[Federal Register Volume 86, Number 116 (Monday, June 21, 2021)]
[Rules and Regulations]
[Pages 32376-32628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12428]
Vol. 86
Monday,
No. 116
June 21, 2021
Part II
Department of Labor
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Occupational Safety and Health Administration
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29 CFR Part 1910
Occupational Exposure to COVID-19; Emergency Temporary Standard;
Interim Final Rule
Federal Register / Vol. 86 , No. 116 / Monday, June 21, 2021 / Rules
and Regulations
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2020-0004]
RIN 1218-AD36
Occupational Exposure to COVID-19; Emergency Temporary Standard
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Interim final rule; request for comments.
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SUMMARY: The Occupational Safety and Health Administration (OSHA) is
issuing an emergency temporary standard (ETS) to protect healthcare and
healthcare support service workers from occupational exposure to COVID-
19 in settings where people with COVID-19 are reasonably expected to be
present. During the period of the emergency standard, covered
healthcare employers must develop and implement a COVID-19 plan to
identify and control COVID-19 hazards in the workplace. Covered
employers must also implement other requirements to reduce transmission
of COVID-19 in their workplaces, related to the following: Patient
screening and management; Standard and Transmission-Based Precautions;
personal protective equipment (PPE), including facemasks or
respirators; controls for aerosol-generating procedures; physical
distancing of at least six feet, when feasible; physical barriers;
cleaning and disinfection; ventilation; health screening and medical
management; training; anti-retaliation; recordkeeping; and reporting.
The standard encourages vaccination by requiring employers to provide
reasonable time and paid leave for employee vaccinations and any side
effects. It also encourages use of respirators, where respirators are
used in lieu of required facemasks, by including a mini respiratory
protection program that applies to such use. Finally, the standard
exempts from coverage certain workplaces where all employees are fully
vaccinated and individuals with possible COVID-19 are prohibited from
entry; and it exempts from some of the requirements of the standard
fully vaccinated employees in well-defined areas where there is no
reasonable expectation that individuals with COVID-19 will be present.
DATES:
Effective dates: The rule is effective June 21, 2021. The
incorporation by reference of certain publications listed in the rule
is approved by the Director of the Federal Register as of June 21,
2021.
Compliance dates: Compliance dates for specific provisions are in
29 CFR 1910.502(s). Employers must comply with all requirements of this
section, except for requirements in paragraphs (i), (k), and (n) by
July 6, 2021. Employers must comply with the requirements in paragraphs
(i), (k), and (n) by July 21, 2021.
Comments due: Written comments, including comments on any aspect of
this ETS and whether this ETS should become a final rule, must be
submitted by July 21, 2021 in Docket No. OSHA-2020-0004. Comments on
the information collection determination described in Section VII.K of
the preamble (OMB Review under the Paperwork Reduction Act of 1995) may
be submitted by August 20, 2021 in Docket Number OSHA-2021-0003.
ADDRESSES: In accordance with 28 U.S.C. 2112(a), the agency designates
Edmund C. Baird, Associate Solicitor of Labor for Occupational Safety
and Health, Office of the Solicitor, U.S. Department of Labor, to
receive petitions for review of the ETS. Service can be accomplished by
email to zzSOL-Covid19-ETS@dol.gov.
Written comments: You may submit comments and attachments,
identified by Docket No. OSHA-2020-0004, electronically at
www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
the online instructions for making electronic submissions.
Instructions: All submissions must include the agency's name and
the docket number for this rulemaking (Docket No. OSHA-2020-0004). All
comments, including any personal information you provide, are placed in
the public docket without change and may be made available online at
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting information they do not want made available to the public or
submitting materials that contain personal information (either about
themselves or others), such as Social Security Numbers and birthdates.
Docket: To read or download comments or other material in the
docket, go to Docket No. OSHA-2020-0004 at www.regulations.gov. All
comments and submissions are listed in the www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through that website. All comments and
submissions, including copyrighted material, are available for
inspection through the OSHA Docket Office. Documents submitted to the
docket by OSHA or stakeholders are assigned document identification
numbers (Document ID) for easy identification and retrieval. The full
Document ID is the docket number plus a unique four-digit code. OSHA is
identifying supporting information in this ETS by author name and
publication year, when appropriate. This information can be used to
search for a supporting document in the docket at http://www.regulations.gov. Contact the OSHA Docket Office at 202-693-2350
(TTY number: 877-889-5627) for assistance in locating docket
submissions.
FOR FURTHER INFORMATION CONTACT:
General information and press inquiries: Contact Frank Meilinger,
Director, Office of Communications, U.S. Department of Labor; telephone
(202) 693-1999; email meilinger.francis2@dol.gov.
For technical inquiries: Contact Andrew Levinson, Directorate of
Standards and Guidance, U.S. Department of Labor; telephone (202) 693-
1950.
SUPPLEMENTARY INFORMATION: The preamble to the ETS on occupational
exposure to COVID-19 follows this outline:
Table of Contents
I. Executive Summary
II. History of COVID-19
III. Pertinent Legal Authority
IV. Rationale for the ETS
A. Grave Danger
B. Need for the ETS
V. Need for Specific Provisions of the ETS
VI. Feasibility
A. Technological Feasibility
B. Economic Feasibility
VII. Additional Requirements
VIII. Summary and Explanation of the ETS
Authority and Signature
I. Executive Summary
This ETS is based on the requirements of the Occupational Safety
and Health Act (OSH Act or Act) and legal precedent arising under the
Act. Under section 6(c)(1) of the OSH Act, 29 U.S.C. 655(c)(1), OSHA
shall issue an ETS if the agency determines that employees are exposed
to grave danger from exposure to substances or agents determined to be
toxic or physically harmful or from new hazards, and an ETS is
necessary to protect employees from such danger. These legal
requirements are more fully discussed in Pertinent Legal Authority
(Section III of this preamble).
For the first time in its 50-year history, OSHA faces a new hazard
so grave that it has killed nearly 600,000
people in the United States in barely over a year, and infected
millions more (CDC, May 24, 2021a). And the impact of this new illness
has been borne disproportionately by the healthcare and healthcare
support workers tasked with caring for those infected by this disease.
As of May 24, 2021, over 491,816 healthcare workers have contracted
COVID-19, and more than 1,600 of those workers have died (CDC, May 24,
2021b). OSHA has determined that employee exposure to this new hazard,
SARS-CoV-2 (the virus that causes COVID-19), presents a grave danger to
workers in all healthcare settings in the United States and its
territories where people with COVID-19 are reasonably expected to be
present. This finding of grave danger is based on the science of how
the virus spreads and the elevated risk in workplaces where COVID-19
patients are cared for, as well as the adverse health effects suffered
by those diagnosed with COVID-19, as discussed in Grave Danger (Section
IV.A. of this preamble).
OSHA has also determined that an ETS is necessary to protect
healthcare and healthcare support employees in covered healthcare
settings from exposures to SARS-CoV-2, as discussed in Need for the ETS
(Section IV.B. of this preamble). Workers face a particularly elevated
risk of exposure to SARS-CoV-2 in settings where patients with
suspected or confirmed COVID-19 receive treatment or where patients
with undiagnosed illnesses come for treatment (e.g., emergency rooms,
urgent care centers), especially when providing care or services
directly to those patients. Through its enforcement efforts to date,
OSHA has encountered significant obstacles, revealing that existing
standards, regulations, and the OSH Act's General Duty Clause are
inadequate to address the COVID-19 hazard for employees covered by this
ETS. The agency has determined that a COVID-19 ETS is necessary to
address these inadequacies. Additionally, as states and localities have
taken increasingly more divergent approaches to COVID-19 workplace
regulation--ranging from states with their own COVID-19 ETSs to states
with no workplace protections at all--it has become clear that a
Federal standard is needed to ensure sufficient protection for
healthcare employees in all states.
The development of safe and highly effective vaccines and the on-
going nationwide distribution of these vaccines are encouraging
milestones in the nation's response to COVID-19. OSHA recognizes the
promise of vaccines to protect workers, but as of the time of the
promulgation of the ETS, vaccination has not eliminated the grave
danger presented by the SARS-CoV-2 virus to the entire healthcare
workforce. Indeed, approximately a quarter of healthcare workers have
not yet completed COVID-19 vaccination (King et al., April 24, 2021).
Nonetheless, vaccination is critical in combatting COVID-19, and the
standard requires employers to provide paid leave to employees so that
they can be vaccinated and recover from any side effects. Additionally,
certain workplaces and well-defined areas where all employees are fully
vaccinated are exempted from all of the standard's requirements, and
certain fully vaccinated workers are exempted from several of the
standard's requirements. OSHA will continue to monitor trends in COVID-
19 infections and deaths as more of the workforce and the general
population become vaccinated and the pandemic continues to evolve.
Where OSHA finds a grave danger from the virus no longer exists for the
covered workforce (or some portion thereof), or new information
indicates a change in measures necessary to address the grave danger,
OSHA will update the ETS, as appropriate.
To protect workers in the meantime, however, a multi-layered
approach to controlling occupational exposures to SARS-CoV-2 in
healthcare workplaces is required. As discussed in the Need for
Specific Provisions (Section V of this preamble), OSHA relied on the
best available science for its decisions concerning appropriate
provisions for the ETS and its determinations regarding the kind and
degree of protective actions needed to protect against exposure to
SARS-CoV-2 at work and the feasibility of instituting these provisions.
More specifically, the agency's analysis demonstrates that an effective
COVID-19 control program must utilize a suite of overlapping controls
in a layered approach to protect workers from workplace exposure to
SARS-CoV-2. OSHA emphasizes that the infection control practices
required by the ETS are most effective when used together; however,
they are also each individually protective.
The agency has also evaluated the feasibility of this ETS and has
determined that the requirements of the ETS are both economically and
technologically feasible, as outlined in Feasibility (Section VI of
this preamble). Table I.-1, which is derived from material presented in
Section VI of this preamble, provides a summary of OSHA's best estimate
of the costs and benefits of the rule using a discount rate of 3
percent. The specific requirements of the ETS are outlined and
described in the Summary and Explanation (Section VIII of this
preamble). OSHA requests comments on the provisions of the ETS and
whether it should be adopted as a permanent standard.
[GRAPHIC] [TIFF OMITTED] TR21JN21.000
II. History of COVID-19
The global pandemic of respiratory disease (coronavirus disease
2019 or ``COVID-19'') caused by a novel coronavirus (SARS-CoV-2) has
been taking an enormous toll on individuals, workplaces, and
governments around the world since early 2020. According to the World
Health Organization (WHO), as of May 24, 2021, there had been
166,860,081 confirmed cases of COVID-19 globally, resulting in more
than 3,459,996 deaths (WHO, May 24, 2021). In the United States as of
the same date, the CDC reported over 32,947,548 cases in the United
States and over 587,342 deaths due to the disease (CDC, May 24, 2021a;
CDC, May 24, 2021c). Among healthcare workers specifically, as of May
24, 2021, 491,816 healthcare workers in the United States had
contracted COVID-19, and at least 1,611 of those workers had died; both
of those figures are likely an undercount (CDC, May 24, 2021b).
The first confirmed case of COVID-19 was identified in the Hubei
Province of China in December of 2019 (Chen et al., August 6, 2020). On
December 31, 2019, China reported to the WHO that it had identified
several influenza-like cases of unknown cause in Wuhan, China (WHO,
January 5, 2020). Soon, COVID-19 infections had spread throughout Asia,
Europe, and North and South America. By February 2020, 58 other
countries had reported COVID-19 cases (WHO, March 1, 2020). By March
2020, widespread local transmission of the virus was established in 88
countries. Because of the widespread transmission and severity of the
disease, along with what the WHO described as alarming levels of
inaction, the WHO officially declared COVID-19 a pandemic on March 11,
2020 (WHO, March 11, 2020).
The first reported case of COVID-19 in the United States was in the
state of Washington, on January 21, 2020, in a person who had returned
from Wuhan, China on January 15, 2020 (CDC, January 21, 2020). On
January 31, 2020, the COVID-19 outbreak was declared to be a U.S.
public health emergency (US DHHS, January 31, 2020). After the initial
report of the virus in January 2020, a steep increase in COVID-19 cases
in the U.S. was observed though March and early April. In the six weeks
between March 1, 2020 and April 12, 2020, the 7-day moving average of
new cases rose from only 57 to 31,779 (CDC, May 24, 2021d). The
President declared the COVID-19 outbreak a national emergency on March
13, 2020 (The White House, March 13, 2020). As of March 19, 2020, all
50 states and the District of Columbia had declared emergencies related
to the pandemic
(NGA, March 19, 2020; NGA, December 4, 2020; Ayanian, June 3, 2020).
The U.S. Food and Drug Administration (FDA) issued or expanded
emergency use authorizations (EUAs) for three COVID-19 vaccines between
December 2020 and May 2021. Currently, everyone in the United States
age 12 and older is eligible to receive a COVID-19 vaccine. As of May
24, 2021, the CDC reported that 163,907,827 people had received at
least one dose of vaccine and 130,615,797 people were fully vaccinated,
representing 45 percent and 32.8 percent of the total U.S. population,
respectively (CDC, May 24, 2021e). Vaccination rates are higher among
people ages 65 and older than among the rest of the population.
Despite the relatively rapid distribution of vaccines in many areas
of the U.S., a substantial proportion of the working age population
remains unvaccinated and susceptible to COVID-19 infection, including
approximately a quarter of all healthcare and healthcare support
workers (King et al., April 24, 2021). And, as discussed in more detail
in Grave Danger (Section IV.A. of this preamble), because workers in
healthcare settings where COVID-19 patients are treated continue to
have regular exposure to SARS-CoV-2 and any variants that develop, they
remain at an elevated risk of contracting COVID-19 regardless of
vaccination status. Therefore, OSHA has determined that a grave danger
to healthcare and healthcare support workers remains, despite the
fully-vaccinated status of some workers, and that an ETS is necessary
to address this danger (see Grave Danger and Need for the ETS (Sections
IV.A. and IV.B. of this preamble)).
References
Ayanian, JZ. (2020, June 3). Taking shelter from the COVID storm.
JAMA Health Forum. https://jamanetwork.com/channels/health-forum/fullarticle/2766931. (Ayanian, June 3, 2020).
Centers for Disease Control and Prevention (CDC). (2020, January
21). First travel-related case of 2019 novel coronavirus detected in
United States. https://www.cdc.gov/media/releases/2020/p0121-novel-coronavirus-travel-case.html. (CDC, January 21, 2020).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021a)
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
Cases & Deaths among Healthcare Personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel. (CDC, May 24, 2021b)
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021c).
Centers for Disease Control and Prevention (CDC). (2021d, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Daily Trends in Number
of COVID-19 Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May
24, 2021d).
Centers for Disease Control and Prevention (CDC). (2021e, May 24).
COVID-19 Vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccinations. (CDC, May 24, 2021e).
Chen, Y.-T, et al., (2020, August 6). An examination on the
transmission of COVID-19 and the effect of response strategies: A
comparative analysis. International Journal of Environmental
Research and Public Health 17(16):5687. https://www.mdpi.com/1660-4601/17/16/5687. (Chen et al., August 6, 2020).
King, WC, et al., (2021, April 24). COVID-19 vaccine hesitancy
January-March 2021 among 18-64 year old US adults by employment and
occupation. medRxiv; https://www.medrxiv.org/content/10.1101/2021.04.20.21255821v3. (King et al., April 24, 2021).
National Governor's Association (NGA). (2020, March 19).
Coronavirus:what you need to know. https://www.nga.org/coronavirus/.
(NGA, March 19, 2020).
National Governor's Association (NGA). (2020, December 4). Summary
of state pandemic mitigation actions. https://www.nga.org/coronavirus-mitigation-actions/. (NGA, December 4, 2020).
The White House. (2020, March 13). Proclamation on declaring a
national emergency concerning the novel coronavirus disease (COVID-
19) outbreak. https://web.archive.org/web/20200313234554/https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. (The White House, March 13, 2020).
United States Department of Health and Human Services (US DHHS).
(2020, January 31). Determination that a public health emergency
exists. https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx. (US DHHS, January 31, 2020).
World Health Organization (WHO). (2020, January 5). Emergencies
preparedness, response--Pneumonia of unknown cause--China. Disease
outbreak news. https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/. (WHO, January 5, 2020).
World Health Organization (WHO). (2020, March 1). Coronavirus
disease 2019 (COVID-19) situation report--41. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200301-sitrep-41-covid-19.pdf?sfvrsn=6768306d_2. (WHO, March 1, 2020).
World Health Organization (WHO). (2020, March 11). Coronavirus
disease 2019 (COVID-19) situation report--51. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200311-sitrep-51-covid-19.pdf?sfvrsn=1ba62e57_10. (WHO, March 11, 2020).
World Health Organization (WHO). (2021, May 24). WHO Coronavirus
Disease (COVID-19) Dashboard. https://covid19.who.int/table. (WHO,
May 24, 2021).
III. Pertinent Legal Authority
The purpose of the Occupational Safety and Health Act of 1970 (OSH
Act), 29 U.S.C. 651 et seq., is ``to assure so far as possible every
working man and woman in the Nation safe and healthful working
conditions and to preserve our human resources.'' 29 U.S.C. 651(b). To
this end, Congress authorized the Secretary of Labor (Secretary) to
promulgate and enforce occupational safety and health standards under
sections 6(b) and (c) of the OSH Act.\1\ 29 U.S.C. 655(b). These
provisions provide bases for issuing occupational safety and health
standards under the Act. Once OSHA has established as a threshold
matter that a health standard is necessary under section 6(b) or (c)--
i.e., to reduce a significant risk of material health impairment, or a
grave danger to employee health--the Act gives the Secretary ``almost
unlimited discretion to devise means to achieve the congressionally
mandated goal'' of protecting employee health, subject to the
constraints of feasibility. See United Steelworkers of Am. v. Marshall,
647 F.2d 1189, 1230 (D.C. Cir. 1981). A standard's individual
requirements need only be ``reasonably related'' to the purpose of
ensuring a safe and healthful working environment. Id. at 1237, 1241;
see also Forging Industry Ass'n v. Sec'y of Labor, 773 F.2d 1436, 1447
(4th Cir. 1985). OSHA's authority to regulate employers is hedged by
constitutional considerations and, pursuant to section 4(b)(1) of the
OSH Act, the regulations and enforcement policies of other
federal agencies. Chao v. Mallard Bay Drilling, Inc., 534 U.S. 235, 241
(2002).
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\1\ The Secretary has delegated most of his duties under the OSH
Act to the Assistant Secretary of Labor for Occupational Safety and
Health. Secretary's Order 08-2020, 85 FR 58393 (Sept. 18, 2020).
This section uses the terms Secretary and OSHA interchangeably.
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The OSH Act reflects Congress's determination that the costs of
compliance with the Act and OSHA standards are part of the cost of
doing business and OSHA may foreclose employers from shifting those
costs to employees. See Am. Textile Mfrs. Inst., Inc. v. Donovan, 452
U.S. 490, 514 (1981); Phelps Dodge Corp. v. OSHRC, 725 F.2d 1237, 1239-
40 (9th Cir. 1984); see also Sec'y of Labor v. Beverly Healthcare-
Hillview, 541 F.3d 193 (3d Cir. 2008). Furthermore, the Act and its
legislative history ``both demonstrate unmistakably'' OSHA's authority
to require employers to temporarily remove workers from the workplace
to prevent exposure to a health hazard. United Steelworkers of Am., 647
F.2d at 1230.
The OSH Act states that the Secretary ``shall'' issue an emergency
temporary standard (ETS) if he finds that the ETS is necessary to
address a grave danger to workers. See 29 U.S.C. 655(c). In particular,
the Secretary shall provide, without regard to the requirements of
chapter 5, title 5, United States Code, for an emergency temporary
standard to take immediate effect upon publication in the Federal
Register if he determines that employees are exposed to grave danger
from exposure to substances or agents determined to be toxic or
physically harmful or from new hazards, and that such emergency
standard is necessary to protect employees from such danger. 29 U.S.C.
655(c)(1).
A separate section of the OSH Act, section 8(c), authorizes the
Secretary to prescribe regulations requiring employers to make, keep,
and preserve records that are necessary or appropriate for the
enforcement of the Act. 29 U.S.C. 657(c)(1). Section 8(c) also provides
that the Secretary shall require employers to keep records of, and
report, work-related deaths and illnesses. 29 U.S.C. 657(c)(2).
The ETS provision, section 6(c)(1), exempts the Secretary from
procedural requirements contained in the OSH Act and the Administrative
Procedure Act, including those for public notice, comments, and a
rulemaking hearing. See, e.g., 29 U.S.C. 655(b)(3); 5 U.S.C. 552, 553.
For that reason, ETSs have been referred to as the ``most dramatic
weapon in [OSHA's] arsenal.'' Asbestos Info. Ass'n/N. Am. v. OSHA, 727
F.2d 415, 426 (5th Cir. 1984).
The Secretary must issue an ETS in situations where employees are
exposed to a ``grave danger'' and immediate action is necessary to
protect those employees from such danger. 29 U.S.C. 655(c)(1); Pub.
Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156 (D.C. Cir.
1983). The determination of what exact level of risk constitutes a
``grave danger'' is a ``policy consideration that belongs, in the first
instance, to the Agency.'' Asbestos Info. Ass'n, 727 F.2d at 425
(accepting OSHA's determination that eighty lives at risk over six
months was a grave danger); Indus. Union Dep't, AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607, 655 n.62 (1980). However, a ``grave
danger'' represents a risk greater than the ``significant risk'' that
OSHA must show in order to promulgate a permanent standard under
section 6(b) of the OSH Act, 29 U.S.C. 655(b). Int'l Union, United
Auto., Aerospace, & Agr. Implement Workers of Am., UAW v. Donovan, 590
F. Supp. 747, 755-56 (D.D.C. 1984), adopted, 756 F.2d 162 (D.C. Cir.
1985); see also Indus. Union Dep't, AFL-CIO, 448 U.S. at 640 n.45
(noting the distinction between the standard for risk findings in
permanent standards and ETSs).
In determining the type of health effects that may constitute a
``grave danger'' under the OSH Act, the Fifth Circuit emphasized ``the
danger of incurable, permanent, or fatal consequences to workers, as
opposed to easily curable and fleeting effects on their health.'' Fla.
Peach Growers Ass'n, Inc. v. U.S. Dep't of Labor, 489 F.2d 120, 132
(5th Cir. 1974). Although the findings of grave danger and necessity
must be based on evidence of ``actual, prevailing industrial
conditions,'' see Int'l Union, 590 F. Supp. at 751, OSHA need not wait
for deaths to occur before promulgating an ETS, see Fla. Peach Growers
Ass'n., 489 F.2d at 130. When OSHA determines that exposure to a
particular hazard would pose a grave danger to workers, OSHA can assume
an exposure to a grave danger wherever that hazard is present in a
workplace. Dry Color Mfrs. Ass'n, Inc. v. Department of Labor, 486 F.2d
98, 102 n.3 (3d Cir. 1973). In demonstrating that an ETS is necessary,
the Fifth Circuit considered whether OSHA had shown that there were no
other means of addressing the risk than an ETS. Asbestos Info. Ass'n,
727 F.2d at 426 (holding that necessity had not been proven where OSHA
could have increased enforcement of already-existing standards to
address the grave risk to workers from asbestos exposure).
On judicial review of an ETS, OSHA is entitled to great deference
on the determinations of grave danger and necessity required under
section 6(c)(1). See, e.g., Pub. Citizen Health Research Grp., 702 F.2d
at 1156; Asbestos Info. Ass'n, 727 F.2d at 422 (judicial review of
these legislative determinations requires deference to the agency); cf.
American Dental Ass'n v. Martin, 984 F.2d 823, 831 (7th Cir. 1993)
(``the duty of a reviewing court of generalist judges is merely to
patrol the boundary of reasonableness''). These determinations are
``essentially legislative and rooted in inferences from complex
scientific and factual data.'' Pub. Citizen Health Research Grp., 702
F.2d at 1156. The agency is not required to support its conclusions
``with anything approaching scientific certainty'' and has the
``prerogative to choose between conflicting evidence.'' Indus. Union
Dep't, AFL-CIO, 448 U.S. at 656; Asbestos Info. Ass'n, 727 F.2d at 425.
The determinations of the Secretary in issuing standards under
section 6 of the OSH Act, including ETSs, must be affirmed if supported
by ``substantial evidence in the record considered as a whole.'' 29
U.S.C. 655(f). The Supreme Court described substantial evidence as ``
`such relevant evidence as a reasonable mind might accept as adequate
to support a conclusion.' '' Am. Textile Mfrs. Inst., 452 U.S. at 522-
23 (quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 477 (1951)).
The Court also noted that `` `the possibility of drawing two
inconsistent conclusions from the evidence does not prevent an
administrative agency's finding from being supported by substantial
evidence.' '' Am. Textile Mfrs. Inst., 452 U.S. at 523 (quoting Consolo
v. FMC, 383 U.S. 607, 620 (1966)). The Fifth Circuit, recognizing the
size and complexity of the rulemaking record before it in the case of
OSHA's ETS for organophosphorus pesticides, stated that a court's
function in reviewing an ETS to determine whether it meets the
substantial evidence standard is ``basically [to] determine whether the
Secretary carried out his essentially legislative task in a manner
reasonable under the state of the record before him.'' Fla Peach
Growers Ass'n., 489 F.2d at 129.
Although Congress waived the ordinary rulemaking procedures in the
interest of ``permitting rapid action to meet emergencies,'' section
6(e) of the OSH Act, 29 U.S.C. 655(e), requires OSHA to include a
statement of reasons for its action when it issues any standard. Dry
Color Mfrs., 486 F.2d at 105-06 (finding OSHA's statement of reasons
inadequate). By requiring the agency to articulate its reasons for
issuing an ETS, the requirement acts as ``an essential safeguard to
emergency temporary standard-setting.'' Id. at 106. However, the Third
Circuit noted that it did not require justification of ``every
substance, type of use or production
technique,'' but rather a ``general explanation'' of why the standard
is necessary. Id. at 107.
ETSs are, by design, temporary in nature. Under section 6(c)(3), an
ETS serves as a proposal for a permanent standard in accordance with
section 6(b) of the OSH Act (permanent standards), and the Act calls
for the permanent standard to be finalized within six months after
publication of the ETS. 29 U.S.C. 655(c)(3); see Fla. Peach Growers
Ass'n., 489 F.2d at 124. The ETS is effective ``until superseded by a
standard promulgated in accordance with'' section 6(c)(3). 29 U.S.C.
655(c)(2).
It is crucial to note that the language of section 6(c)(1) is not
discretionary: The Secretary ``shall'' provide for an ETS when OSHA
makes the prerequisite findings of grave danger and necessity. Pub.
Citizen Health Research Grp., 702 F.2d at 1156 (noting the mandatory
language of section 6(c)). OSHA is entitled to great deference in its
determinations, and it must also account for ``the fact that `the
interests at stake are not merely economic interests in a license or a
rate structure, but personal interests in life and health.' '' Id.
(quoting Wellford v. Ruckelshaus, 439 F.2d 598, 601 (D.C. Cir. 1971)).
IV. Rationale for the ETS
A. Grave Danger
I. Introduction
On January 31, 2020, the Secretary of Health and Human Services
(HHS) declared COVID-19 to be a public health emergency in the U.S.
under section 319 of the Public Health Service Act. The World Health
Organization declared COVID-19 to be a global health emergency on the
same day. President Donald Trump declared the COVID-19 outbreak to be a
national emergency on March 13, 2020 (The White House, March 13, 2020).
HHS renewed its declaration of COVID-19 as a public health emergency
effective April 21, 2021 (HHS, April 15, 2021).\2\
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\2\ HHS declarations of public health emergencies last for 90
days and then can be considered for renewal (https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx).
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Consistent with these declarations, and in carrying out its legal
duties under the OSH Act, OSHA has determined that healthcare employees
face a grave danger from the new hazard of workplace exposures to SARS-
CoV-2 except under a limited number of situations (e.g., a fully
vaccinated workforce in a breakroom).\3\ The virus is both a physically
harmful agent and a new hazard, and it can cause severe illness,
persistent health effects, and death (morbidity and mortality,
respectively) from the subsequent development of the disease, COVID-
19.\4\ OSHA bases its grave danger determination on evidence
demonstrating the lethality of the disease, the serious physical and
psychiatric health effects of COVID-19 morbidity (in mild-to-moderate
as well as in severe cases), and the transmissibility of the disease in
healthcare settings where people with COVID-19 are reasonably expected
to be present. The protections of this ETS--which will apply, with some
exceptions, to healthcare settings where people may share space with
COVID-19 patients or interact with others who do--are designed to
protect employees from infection with SARS-CoV-2 and from the dire,
sometimes fatal, consequences of such infection.
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\3\ References in this preamble to healthcare employees and
healthcare workers indicate those employees covered by the
protections in the ETS, including employees providing healthcare
support services.
\4\ OSHA is defining the grave danger as workplace exposure to
SARS-CoV-2, the virus that causes the development of COVID-19.
COVID-19 is the disease that can occur in people exposed to SARS-
CoV-2, and that leads to the health effects described in this
section. This distinction applies despite OSHA's use of these two
terms interchangeably in some parts of this preamble.
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The fact that COVID-19 is not a uniquely work-related hazard does
not change the determination that it is a grave danger to which
employees are exposed, nor does it excuse employers from their duty to
protect employees from the occupational transmission of SARS-CoV-2. The
OSH Act is intended to ``assure so far as possible every working man
and woman in the Nation safe and healthful working conditions,'' 29
U.S.C. 651(b), and there is nothing in the Act to suggest that its
protections do not extend to hazards which might occur outside of the
workplace as well as within. Indeed, COVID-19 is not the first hazard
that OSHA has regulated that occurs both inside and outside the
workplace. For example, the hazard of noise is not unique to the
workplace, but the Fourth Circuit has upheld OSHA's Occupational Noise
Exposure standard, 29 CFR 1910.95 (Forging Industry Ass'n v. Secretary,
773 F.2d 1437, 1444 (4th Cir. 1985)). Diseases caused by bloodborne
pathogens, including HIV/AIDS and hepatitis B, are also not unique to
the workplace, but the Seventh Circuit upheld the majority of OSHA's
Bloodborne Pathogens standard, 29 CFR 1910.1030 (Am. Dental Ass'n v.
Martin, 984 F.2d 823 (7th Cir. 1993)). Moreover, employees have more
freedom to control their environment outside of work, and to make
decisions about their behavior and their contact with others to better
minimize their risk of exposure. However, during the workday, while
under the control of their employer, healthcare employees providing
care directly to known or suspected COVID-19 patients are required to
have close contact with infected individuals, and other employees in
those settings also work in an environment in which they have little
control over their ability to limit contact with individuals who may be
infected with COVID-19 even when not engaged in direct patient care.
Accordingly, even though SARS-CoV-2 is a hazard to which employees are
exposed both inside and outside the workplace, healthcare employees in
workplaces where individuals with suspected or confirmed COVID-19
receive care have limited ability to avoid exposure resulting from a
work setting where those individuals are present. OSHA has a mandate to
protect employees from hazards they are exposed to at work, even if
they may be exposed to similar hazards before and after work.
As described above in Section III, Legal Authority, ``grave
danger'' indicates a risk that is more than ``significant'' (Int'l
Union, United Auto., Aerospace, & Agr. Implement Workers of Am., UAW v.
Donovan, 590 F. Supp. 747, 755-56 (D.D.C. 1984); Indus. Union Dep't,
AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 640 n.45, 655 (1980)
(stating that a rate of 1 worker in 1,000 workers suffering a given
health effect constitutes a ``significant'' risk)). ``Grave danger,''
according to one court, refers to ``the danger of incurable, permanent,
or fatal consequences to workers, as opposed to easily curable and
fleeting effects on their health'' (Fla. Peach Growers Ass'n, Inc. v.
U. S. Dep't of Labor, 489 F.2d 120, 132 (5th Cir. 1974)). Fleeting
effects were described as nausea, excessive salivation, perspiration,
or blurred vision and were considered so minor that they often went
unreported, which is in contrast to the adverse health effects of cases
of COVID-19, which are formally referenced as ranging from ``mild'' to
``critical.'' \5\ Beyond this, however, ``the determination of what
constitutes a risk worthy of Agency action is a policy consideration
that belongs, in the first instance, to the Agency'' (Asbestos Info.
Ass'n/N. Am. v. OSHA, 727 F.2d 415, 425 (5th Cir. 1984)).
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\5\ Definitions of severity of COVID-19 illness used in this
document are found in the National Institutes of Health's COVID-19
treatment guidelines (https://www.covid19treatmentguidelines.nih.gov/overview/clinical-spectrum/)
(NIH, December 17, 2020).
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In the context of ordinary 6(b) rulemaking, the Supreme Court has
said that the OSH Act is not a ``mathematical straitjacket,'' nor does
it require the agency to support its findings ``with anything
approaching scientific certainty,'' particularly when operating on the
``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
Am. Petroleum Inst., 448 U.S. 607, 656, 100 S. Ct. 2844, 2871, 65 L.
Ed. 2d 1010 (1980)). Courts reviewing OSHA's determination of grave
danger do so with ``great deference'' (Pub. Citizen Health Research
Grp. v. Auchter, 702 F.2d 1150, 1156 (D.C. Cir. 1983)). In one case,
the Fifth Circuit, in reviewing an OSHA ETS for asbestos, declined to
question the agency's finding that 80 worker lives at risk over six
months constituted a grave danger (Asbestos Info. Ass'n/N. Am., 727
F.2d at 424). In stark contrast, as of May 24, 2021, 1,611 healthcare
personnel have died (out of 491,816 healthcare COVID-19 cases where
healthcare personnel status and death status is known by the CDC) (May
24, 2021a). This is likely an undercount of cases and deaths as the
healthcare personnel status is not known for 81.63% of cases and death
status is unknown in 20.42% of cases where healthcare personnel status
is known. OSHA estimates that this rule would save almost 800 worker
lives over the course of the next six months as noted in Table I.-1 in
the Executive Summary. Here, the mortality and morbidity risk to
employees from COVID-19 is so dire that the grave danger from exposures
to SARS-CoV-2 is clear.
OSHA's previous ETSs addressed physically harmful agents that had
been familiar to the agency for many years prior to the ETS. In most
cases, the ETSs were issued in response to new information about
substances that had been used in workplaces for decades (e.g., Vinyl
Chloride (39 FR 12342 (April 5, 1974)); Benzene (42 FR 22516 (May 3,
1977)); 1,2-Dibromo-3-chloropropane (42 FR 45536 (Sept. 9, 1977))). In
some cases, the hazards of the toxic substance were already so well
established that OSHA promulgated an ETS simply to update an existing
standard (e.g., Vinyl cyanide (43 FR 2586 (Jan. 17, 1978)). In no case
did OSHA claim that an ETS was required to address a grave danger from
a substance that had only recently come into existence. Thus, no court
has had occasion to separately examine OSHA's authority under section
(6)(c) of the OSH Act (29 U.S.C. 655(c)) to address a grave danger from
a ``new hazard.'' Yet by any measure, SARS-CoV-2 is a new hazard.
Unlike any of the hazards addressed in previous ETSs, SARS-CoV-2 was
not known to exist until January 2020. Since then, more than 3 million
people have died worldwide and nearly 600,000 people have died in the
U.S. alone (WHO, May 24, 2021; CDC, May 24, 2021b). This monumental
tragedy is largely handled by healthcare employees who provide care for
those who are ill and dying, leading to introduction of the virus not
only in their daily lives in the community but also in their workplace,
and more than a thousand healthcare workers have died from COVID-19.
Clearly, exposure to SARS-CoV-2 is a new hazard that presents a grave
danger to workers in the U.S.
In the following sections within Grave Danger, OSHA summarizes the
best available scientific evidence on employee exposure to SARS-CoV-2
and shows how that evidence establishes COVID-19 to be a grave danger
to healthcare employees. OSHA's determination that there is a grave
danger to healthcare employees rests on the severe health consequences
of COVID-19, the high risk to employees of developing the disease as a
result of transmission of SARS-CoV-2 in the workplace, and that these
workplace settings provide direct care to known or suspected COVID-19
cases. With respect to the health consequences of COVID-19, OSHA finds
a grave danger to employees based on mortality data showing
unvaccinated people of working age (18-64 years old) have a 1 in 217
chance of dying when they contract the disease (May 24, 2021c; May 24,
2021d). When broken down by age range, that includes a 1 in 788 chance
of dying for those aged 30-39, a 1 in 292 chance of dying for those
aged 40-49, and as much as a 1 in 78 chance of dying for those aged 50-
64 (May 24, 2021c; May 24, 2021d). Furthermore, workers in racial and
ethnic minority groups are often over-represented in many healthcare
occupations and face higher risks for SARS-CoV-2 exposure and
infection, as noted in a study on workers in Massachusetts (Hawkins,
June 15, 2020) and discussed in more detail in the section ``Observed
Disparities in Risk Based on Race and Ethnicity,'' below. While
vaccination greatly reduces adverse health outcomes to healthcare
workers, it does not eliminate the grave danger faced by vaccinated
healthcare workers in settings where patients with suspected or
confirmed COVID-19 receive treatment (CDC, April 27, 2021; Howard, May
22, 2021).
OSHA also finds a grave danger based on the severity and prevalence
of other health effects caused by COVID-19, short of death. While some
SARS-CoV-2 infections are asymptomatic, even the cases labeled ``mild''
by the CDC involve symptoms that far exceed in severity the group of
symptoms dismissed in the Florida Peach Growers Ass'n decision as not
rising to the level of grave danger required by the OSH Act (i.e.,
minor cases of nausea, excessive salivation, perspiration, or blurred
vision) (489 F.2d at 132). Even ``mild'' cases of COVID-19--where
hypoxia (low oxygen in the tissues) is not present--require isolation
and may require medical intervention and multiple weeks of
recuperation, while severe cases of COVID-19 typically require
hospitalization and a long recovery period (see the section on ``Health
Effects,'' below). For example, in a study of 1,733 patients, three
quarters of remaining hospitalized cases and approximately half of all
symptomatic cases resulted in the individual continuing to experience
at least one symptom (e.g., fatigue, breathing difficulties) at least
six months after initial infection (Huang et al., January 8, 2021;
Klein et al., February 15, 2021). These cases might be referred to as
``long COVID'' because symptoms persist long after recovery from the
initial illness, and could potentially be significant enough to
negatively affect an individual's ability to work or perform other
everyday activities.
Finally, OSHA concludes that the serious and potentially fatal
consequences of COVID-19 pose a particular threat to employees, as the
nature of SARS-CoV-2 transmission readily enables the virus to spread
when employees are working in spaces shared with others (e.g., co-
workers, patients, visitors), a common characteristic of healthcare
settings where direct care is provided. While not every setting is
represented in the evidence that OSHA has assembled, the best available
evidence illustrates that clusters and outbreaks \6\ of COVID-19 have
occurred in a wide variety of occupations in healthcare settings. The
scientific
evidence of SARS-CoV-2 transmission, presented below, makes clear that
the virus can be spread wherever an infectious person is present and
shares space with other people, and OSHA therefore expects transmission
across healthcare workplaces where known or suspected COVID-19 patients
are treated (see Dry Color Mfrs. Ass'n, Inc. v. Dep't of Labor, 486
F.2d 98, 102 n.3 (3d Cir. 1973) (holding that when OSHA determines a
substance poses a grave danger to workers, OSHA can assume an exposure
to a grave danger wherever that substance is present in a workplace)).
OSHA's conclusion that there is a grave danger to which employees are
specifically exposed is further supported by evidence demonstrating the
widespread prevalence of the disease across the country generally. As
of May 2021, over 32 million cases of COVID-19 have been reported in
the United States (CDC, May 24, 2021e). Over 1 in 11 people of working
age have been reported infected (cases for individuals age 18-64, CDC,
May 24, 2021d; estimated number of people ages 15-64, Census Bureau,
June 25, 2020). And data shows that employees across a myriad of
workplace settings have suffered death and serious illness from COVID-
19 through the duration of the pandemic (WSDH and WLNI, December 17,
2020; Allan-Blitz et al., December 11, 2020; Marshall et al., June 30,
2020).\7\ From May 18, 2021 to May 24, 2021, COVID-19 resulted in 4,216
cases and nine deaths for healthcare personnel each day (CDC, May 18,
2021; CDC, May 24, 2021a). Thus, COVID-19 continues to present a grave
danger to the nation's healthcare employees.
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\6\ ``Outbreaks'' are generally defined as an increase, often
sudden, in the number of cases of a disease above what is normally
expected in a limited geographic area. ``Clusters'' are generally
defined as an unusual number of cases grouped in one place that is
more than expected to occur (CDC, May 18, 2012). Researchers
investigating outbreaks and have to decide how to define the
geographic area, while researchers investigating clusters may use a
variety of strategies to determine what is ``unusual.'' While the
terms are slightly different, their overall significance to the
grave danger discussion is the same. For the studies and reports
relied upon in this section, OSHA will generally use whichever term
is used in the study or report itself.
\7\ Of note, on February 25, 2021, the Superior Court of
California issued a decision denying a motion for a preliminary
injunction seeking to restrain the California Occupational Safety
and Health Standards Board from enforcing a COVID-19 ETS promulgated
on November 30, 2020 (Nat'l Retail Fed'n v. Cal. Dep't of Indus.
Relations, Div. of Occupational Safety & Health, Case Nos. CGC-20-
588367, CPF-21-517344 (Cal. Super. Ct., Feb. 25, 2021)). In its
decision, the court found that COVID-19 presents an emergency to
employees, noting that any argument to the contrary was ``fatuous''
(id. at 17). The court found that ``the virus spreads any place
where persons gather and come into contact with one another--whether
it happens to be an office building, a meatpacking plant, a wedding
reception, a business conference, or an event in the Rose Garden of
the White House. Workplaces, where employees often spend eight hours
a day or more in close proximity to one another, are no exception,
which of course is why the pandemic has emptied innumerable office
buildings, stores, shopping centers, restaurants, and bars around
the world'' (id. at 17-18 (emphasis in original) (footnotes
omitted)).
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References
Allan-Blitz, LT et al., (2020, December 11). High frequency and
prevalence of community-based asymptomatic SARS-CoV-2
infection.medRxivpre-print. https://www.medrxiv.org/content/10.1101/2020.12.09.20246249v1. (Allan-Blitz et al., December 11, 2020).
Centers for Disease Control and Prevention (CDC). (2021, April 27).
Updated healthcare infection prevention and control recommendation
in response to COVID-19 vaccination. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html.
(CDC, April 27, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 18).
COVID Data Tracker: Cases & deaths among healthcare personnel.
https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
(CDC, May 18, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
Cases & Deaths among Healthcare Personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel. (CDC, May 24, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
Demographic Trends of COVID-19 cases and deaths in the US reported
to CDC: Deaths by age group. https://covid.cdc.gov/covid-data-tracker/#demographics (CDC, May 24, 2021c).
Centers for Disease Control and Prevention (CDC). (2021d, May 24).
Demographic Trends of COVID-19 cases and deaths in the US reported
to CDC: Cases by age group. https://covid.cdc.gov/covid-data-tracker/#demographics (CDC, May 24, 2021d).
Centers for Disease Control and Prevention (CDC). (2021e, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021e).
Census Bureau. (2020, June 25). Annual estimates of the resident
population for selected age groups by sex for the United States:
April 2010 to July 1, 2019. https://www2.census.gov/programs-surveys/popest/tables/2010-2019/national/asrh/nc-est2019-agesex.xlsx. (Census Bureau, June 25, 2020).
Hawkins, D. (2020, June 15). Differential occupational risk for
COVID-19 and other infection exposure according to race and
ethnicity. American Journal of Industrial Medicine 63:817-820.
https://doi.org/10.1002/ajim.23145. (Hawkins, June 15, 2020).
Howard, J. (2021). ``Response to request for an assessment by the
National Institute for Occupational Safety and Health, Centers for
Disease Control and Prevention, U.S. Department of Health and Human
Services, of the current hazards facing healthcare workers from
Coronavirus Disease-2019 (COVID-19).'' (Howard, May 22, 2021).
Huang, C et al., (2021, January 8). 6-month consequences of COVID-19
in patients discharged from hospital: A cohort study. The Lancet
397:220-232. https://doi.org/10.1016/S0140-6736(20)32656-8. (Huang
et al., January 8, 2021).
Klein, H et al., (2021, February 15). Onset, duration and unresolved
symptoms, including smell and taste changes, in mild COVID-19
infections: A cohort study in Israeli patients. Clinical
Microbiology and Infection 27(5):769-774. https://doi.org/10.1016/j.cmi.2021.02.008. (Klein et al., February 15, 2021).
Marshall, K et al., (2020, June 30). Exposure before issuance of
stay-at-home orders among persons with laboratory-confirmed COVID-
19--Colorado, March 2020. Morbidity and Mortality Weekly Report:
69(26):847-9. (Marshall et al., June 30, 2020).
United States Department of Health and Human Services (US DHHS).
(2021, April 15). Renewal of Determination That A Public Health
Emergency Exists. https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-15April2021.aspx. (HHS, April 15, 2021).
Washington State Department of Health and Washington State
Department of Labor and Industries (WSDH and WDLI). (2020, December
17). COVID-19 confirmed cases by industry sector. Publication Number
421-002. https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/data-tables/IndustrySectorReport.pdf. (WSDH and WDLI,
December 17, 2020).
The White House. (2020, March 13). Proclamation on declaring a
national emergency concerning the novel coronavirus disease (COVID-
19) outbreak. https://web.archive.org/web/20200313234554/https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. (The White House, March 13, 2020).
World Health Organization (WHO). (2021, May 24). WHO Coronavirus
Disease (COVID-19) Dashboard. https://covid19.who.int/table. (WHO,
May 24, 2021).
II. Nature of the Disease
a. Health and Other Adverse Effects of COVID-19
Death From COVID-19
COVID-19 is a potentially fatal disease. As of May 24, 2021, there
had been 587,432 deaths from the disease out of 32,947,548 million
infections in the United States alone (CDC, May 24, 2021a; CDC, May 24,
2021b). For the U.S. population as a whole (i.e., unlinked to known
SARS-CoV-2
infections) as of May 24, 2021, 1.8 out of every 1,000 people have died
from COVID-19 (CDC, May 24, 2021a). COVID-19 was the third leading
cause of death in the United States in 2020 among those aged 45 to 84,
trailing only heart disease and cancer (Woolf, January 12, 2021).
During the surges in the spring and fall/winter of 2020, COVID-19 was
the leading cause of death. Despite a decrease in recent weeks, the
death rate remains high (7-day moving average death rate of 500 on May
23, 2021) (CDC, May 24, 2021c). Not only are healthcare employees
included in these staggering figures, they are exposed to COVID-19 at a
much higher frequency than the general population while providing
direct care for both sick and dying COVID-19 patients during their most
infectious moments.
The impact of morbidity and mortality on healthcare employees might
also be underreported. The information associated with cases and deaths
are incomplete. Only 18.37% of cases were reported with information on
whether or not the infected individual was a healthcare employee (CDC,
May 24, 2021d). For those who were identified as healthcare personnel,
only 79.58% of these cases noted whether the individual survived the
illness (CDC, May 24, 2021d). Despite the incomplete data, the toll on
healthcare personal is clear. As of May 24, 2021, CDC reported 491,816
healthcare personnel cases (10% of cases that included information on
healthcare personnel status) and 1,611 fatalities (0.4% of healthcare
employee cases with known death status). This number is staggering when
compared with, for example, the 2018-2019 influenza season, during
which only 0.1% of known influenza infections were estimated to be
fatal for the entire population (CDC, October 5, 2020).
The risk of mortality and morbidity from COVID-19 has changed, and
may continue to change over time. Viruses mutate and those mutations
can result in variants of concern that may be more transmissible, cause
more severe illness, or impact diagnostics, treatments, or vaccines
(CDC, May 5, 2021). For example, the UK's New and Emerging Respiratory
Virus Threats Advisory Group (NERVTAG) issued a report on how risk
might have changed with the development of a new variant there called
``B.1.1.7'' (February 11, 2021). The group determined that analysis
from multiple different datasets indicated that B.1.1.7 infections
resulted in an increased risk of hospitalization and death compared
with the ancestral virus and other variants in circulation. Challen et
al., (March 10, 2021) found that B.1.1.7 increased mortality risk by
64%. As virus mutations result in variants of concern, the
effectiveness of medical countermeasures such as therapeutics and
vaccines might be affected. Lastly, depending on the variant, potential
immune escape properties of the virus may increase a person's
susceptibility to reinfection.
Severe and Critical Cases of COVID-19
Apart from mortality, COVID-19 causes significant morbidity that
can result in incurable, permanent, and non-fleeting consequences. As
discussed below, people who become ill with COVID-19 might require
hospitalization and specialized treatment, and can suffer respiratory
failure, blood clots, long-term cardiovascular effects, organ damage,
and significant neurological and psychiatric effects. Approximately
6.7% of COVID-19 cases are severe and require hospitalization and more
specialized care (total hospitalizations and total cases, CDC, May 24,
2021e; CDC, May 24, 2021f). Given that this is a novel virus, long-term
effects are still unknown. A severe case of COVID-19 is described as
when the patient presents with hypoxia and is in need of oxygen therapy
(NIH, April 21, 2021a). Cases become critical when respiratory failure,
septic shock, and/or multiple organ dysfunction occurs.
The majority of the data currently available on the health outcomes
for hospitalized patients is derived from the first surge of the
pandemic between March and May of 2020. However, newer data indicates
that health outcomes for hospitalized patients have changed over the
course of the pandemic. A study from Emory University reviewed COVID-19
patient data from a large multi-hospital healthcare network and
compared the data from the first surge early in the pandemic (March 1
to May 30, 2020) with the second surge that occurred in the summer of
2020 (June 1 to September 13, 2020) (Meena et al., March 1, 2021). The
study found that during the second surge, ICU admission decreased from
38% to 30%, ventilator use decreased from 26% to 15%, and mortality
decreased from 15% to 9%. The study authors postulated that improved
patient outcomes during the second stage may have resulted in part from
aggressive anticoagulation therapies to prevent venous thromboembolism.
Similar findings were reported in a retrospective study of 20,736
COVID-19 patients admitted to 107 hospitals in 31 states from March
through November 2020 (Roth et al., May 3, 2021). The proportions of
patients placed on mechanical ventilation dropped from 23.3% in March
and April 2020 to 13.9% in September through November 2020. During
those same respective time periods, mortality rates dropped from 19.1%
to 10.8%. The reasons for the reductions in mechanical ventilation and
mortality are not known, but study authors postulated that reductions
in mechanical ventilation may have resulted from increased use of
noninvasive ventilation, high flow nasal oxygen, and prone positioning.
They hypothesized that the high patient count and staff unfamiliarity
with infection control procedures that were being rapidly implemented
in March and April could have accounted for the high mortality rate
during that period. In addition, the authors noted that changes in
pharmacology treatments occurred during that time period, but their
impact on improved outcomes is not known.
This data on improvements in health outcomes between earlier and
later stages of the pandemic is significant, but also demonstrates that
overall health outcomes for hospitalized COVID-19 patients still remain
poor. Even with these improvements in health outcomes, COVID-19 still
results in considerable loss of life and significant adverse health
outcomes for patients hospitalized with COVID-19. The COVID-19-
Associated Hospitalization Surveillance Network (COVID-NET), which
conducts population-based surveillance in select U.S. counties,
reported a cumulative hospitalization rate of 1 in 255 people between
the ages of 18 and 49 as well as 1 in 123 people between the ages of 50
and 64 between March 1, 2020, and May 15, 2021 (CDC, May 24, 2021g).
Patients hospitalized with COVID-19 frequently need supplemental
oxygen and supportive management of the disease's most common
complications, which are discussed in further detail below and include
pneumonia, respiratory failure, acute respiratory distress syndrome
(ARDS), acute kidney injury, sepsis, myocardial injury, arrhythmias,
and blood clots. Among 35,302 inpatients in a nationwide U.S. study,
median length of stay was 6 days overall (Rosenthal, et al., December
10, 2020). When cases required treatment in the ICU, ICU stays were on
median 5 days in addition to time spent hospitalized outside of the
ICU. The Roth et al., (May 3, 2021) study described above reported that
mean length of hospital stays decreased from 10.7 days in April and May
2020 to 7.5 days from September to November 2020, and the respective
values for ICU stays over the same time period decreased from 13.9 days
to 6.6 days. As discussed
in more detail above, improvements in infection control and treatment
interventions might be responsible for the improved outcome, but the
specific reason is not known, and the numbers of individuals
hospitalized with COVID-19 remains high.
The pneumonia associated with the SARS-CoV-2 virus can become
severe, resulting in respiratory failure and ARDS, a life-threatening
lung injury. In a U.S. study of 35,302 COVID-19 inpatients, 55.8%
suffered respiratory failure with 8.1% experiencing ARDS (Rosenthal, et
al., December 10, 2020). Thus, the need for oxygen therapy is a key
reason for hospitalization. The specific therapy received during
hospitalization often depends on the severity of lung distress and can
include supplemental oxygen, noninvasive ventilation, intubation for
invasive mechanical ventilation, and extracorporeal membrane
oxygenation when mechanical ventilation is insufficient (NIH, April 21,
2021a).
Although COVID-19 was initially considered to be primarily a
respiratory disease, adverse effects in numerous organs have now been
reported. For example, in a New York City area study of 9,657 COVID-19
patients, 39.9% of patients developed acute kidney injury (AKI), a
sudden episode of kidney failure or kidney damage; of the approximately
40% of patients who developed AKI, 17% required dialysis (Ng et al.,
September 19, 2020). AKI similarly occurred in 33.9% of 35,302
inpatients in a nationwide U.S. study (Rosenthal et al., December 10,
2020). For patients who experience AKI associated with COVID-19, a
study of patients in the New York area reported a median length of stay
in the hospital of 11.6 days for patients who did not require dialysis,
but for those who did, the median length of stay almost tripled to 29.2
days (Ng et al., September 19, 2020). Many critically ill COVID-19
patients require renal replacement therapy (NIH, April 21, 2021a). For
example, one study including 67 U.S. hospitals found that 20.6% of
critically ill COVID-19 patients developed AKI that requires renal
replacement therapy (Gupta et al., 2021).
COVID-19 is also capable of causing viral sepsis, a condition where
the immune response dysregulates and causes life-threatening harm to
organs (e.g., lungs, brain, kidneys, heart, and liver). In Rosenthal et
al.'s, (December 10, 2020) U.S. study through May 31, 2020, 33.7% of
COVID-19 inpatients developed sepsis. A study of 18-49 year olds in the
COVID-NET surveillance system found that 16.6% of patients in that age
range developed sepsis (Owusu et al., December 3, 2020). In a study of
VA hospitals, sepsis was found to be the most common complication that
resulted in readmission within 60 days of being discharged (Donnelly et
al., January 19, 2020).
COVID-19 patients have also been reported to experience a number of
adverse cardiac complications, including arrhythmias, myocardial injury
with elevated troponin levels, and myocarditis (Caforio, December 2,
2020). Acute ischemic heart disease occurred in 8% of 35,302 inpatients
in a nationwide U.S. study (Rosenthal et al., December 10, 2020).
Patients hospitalized with COVID-19 may also experience shock, a
critical condition caused by a sudden drop in blood pressure that can
lead to fatal cardiac complications. Shock occurred in 4,028 of 35,302
(11.4%) inpatients in a nationwide U.S. study (Rosenthal et al.,
December 10, 2020). And a study of 70 COVID-19 patients in a Freiburg
ICU found that shock was a complicating factor in 24% of fatal cases
(Rieg et al., November 12, 2020). A New York City area study reported
that 21.5% of the study's 9,657 patients experience serious drops in
blood pressure that required medical intervention during their hospital
stay (Ng et al., September 19, 2020).
In addition to its adverse effects on specific organs, COVID-19 may
cause patients to develop a hypercoagulable state, a condition in which
blood clots can develop in someone's legs and embolize to their lungs,
further worsening oxygenation. Blood clots in COVID-19 patients have
also been reported in arteries, resulting in strokes--even in young
people--as well as heart attacks and acute ischemia from lack of oxygen
in limbs in which arterial clots have occurred (Cuker and Peyvandi,
November 19, 2020; Oxley et al., May 14, 2020). Blood clots have been
reported even in COVID-19 patients on prophylactic-dose
anticoagulation. A systematic review of more than 28,000 COVID-19
patients found that venous thromboembolism (deep vein thrombosis,
pulmonary embolism or catheter-related thrombosis) occurred in 14% of
hospitalized patients overall and 22.7% of ICU patients (Nopp et al.,
September 25, 2020). Pulmonary embolism was reported in 3.5% of non-ICU
and 13.7% of ICU patients. Embolism and thrombosis can cause death.
COVID-19 poses such a threat of blood clots that NIH guidelines now
recommend that hospitalized non-pregnant adults with COVID-19 should
receive prophylactic dose anticoagulation (NIH, April 21, 2021a).
These health effects are particularly relevant to healthcare
workers because there is evidence that healthcare workers are more
likely to develop more severe COVID-19 symptoms than workers in non-
healthcare settings. While the reason for this is not certain, one
cause could be that healthcare workers are exposed to higher viral
loads (more viral particles entering the body) because of the nature of
their work often involving frequent and sustained close contact with
COVID-19 patients. For example, a British study compared healthcare
workers to other ``essential'' and ``non-essential'' workers and found
that healthcare workers were more than 7 times as likely to experience
severe COVID-19 disease following infection (i.e., disease requiring
hospitalization) than infected non-essential workers (Mutambudzi et
al., 2020).
Mild to Moderate Cases of COVID-19
Even the less severe health effects of COVID-19 cover a wide range
of symptoms and severity, from serious illness to milder symptomatic
illness to asymptomatic cases. The most common symptoms include fever
or chills, cough, shortness of breath or difficulty breathing, fatigue,
muscle or body aches, headache, developing a loss of taste or smell,
sore throat, congestion or runny nose, nausea, vomiting, and/or
diarrhea (CDC, February 22, 2021).
Approximately 80% of symptomatic COVID-19 cases are mild to
moderate (Wu and McGoogan, April 7, 2020), which is defined as having
any symptom of COVID-19 but without substantially decreased oxygen
levels, shortness of breath, or difficulty breathing (NIH, April 21,
2021b). Moderate cases, however, also show evidence of lower
respiratory disease, although these cases largely do not require
admission into hospitals (CDC, February 16, 2021). While deaths and
severe health consequences of COVID-19 are sufficiently robust in
support of OSHA's finding that COVID-19 presents a grave danger, even
many of the typical mild or moderate cases surpass the Florida Peach
Growers threshold of ``fleeting effects . . . so minor that they often
went unreported'' (supra). Mild and moderate cases can be treated at
home but may still require medical intervention (typically through
telehealth visits) (Wu and McGoogan, April 7, 2020). Individuals with
mild cases often need at least one to two weeks to recover enough to
resume work, but effects can potentially last for months. Fatigue,
headache, and muscle aches are among the most commonly-reported
symptoms in people who are
not hospitalized (CDC, February 16, 2021), and their effects are not
fleeting and often linger. In a multistate telephone survey of 292
adults with COVID-19, the majority of whom did not eventually require
hospitalization, 274 (94%) of the survey respondents were symptomatic
at the time of their SARS-CoV-2 test, reporting illness for a median of
three days prior to the positive test (Tenforde et al., July 24, 2020).
Around one third of symptomatic respondents (95 of 274) reported that
they still had not returned to their usual state of health 2-3 weeks
after testing positive. Even among the young adults (aged 18-34 years)
with no chronic medical conditions, nearly one in five had not returned
to their usual state of health 2-3 weeks after testing.
Even though these cases rarely result in hospitalization,
individuals with mild to moderate cases of COVID-19 are also
significantly impacted by their illness as a result of CDC isolation
recommendations. According to the current CDC criteria, a person with
symptomatic COVID-19 should generally discontinue isolation only when
all three of the following conditions have been met: (1) At least 10
days have passed since symptom onset; (2) at least 24 hours have passed
since experiencing a fever without the use of fever-reducing
medications; and (3) other symptoms have improved (other than loss of
taste or smell) (CDC, February 18, 2021). And the CDC notes with
respect to the first criteria that individuals with severe illness or
with compromised immunity might require up to 20 days of isolation.
Even those with mild or moderate cases of COVID-19 may be prevented by
their illness from working from home during the period of isolation.
Longer-Term Health Effects
Recovery from acute infection with the SARS-CoV-2 virus can be
prolonged. Three categories of patients in particular are known to
require ongoing care after resolution of their acute viral infection:
Those with a severe illness requiring hospitalization (especially ICU
care); those with a specific medical complication from the infection,
such as a stroke; and those with milder acute illnesses who experience
persistent symptoms such as fatigue and breathlessness. The lingering
of, or development of, related health effects after a SARS-CoV-2
infection is known as post-acute sequelae. Dr. Francis Collins,
Director of the National Institutes of Health, testified that recovery
can be prolonged even in previously healthy young adults with milder
infections. Some people experience persistent symptoms for weeks or
even months after the acute infection (Collins, April 28, 2021). Post-
Acute COVID-19 syndrome has been proposed as a diagnostic term for
these patients, although the term ``long COVID'' is more common outside
the medical community. According to the CDC, the most common symptoms
of Post-Acute COVID-19 syndrome are fatigue, shortness of breath,
cough, and joint and chest pain (CDC, April 8, 2020). Other symptoms
reported by these patients include decreased memory and concentration,
depression, muscle pain, headache, intermittent fever, and racing heart
(CDC, April 8, 2021). Additional common symptoms, as reported by Dr.
Collins, are abnormal sleep patterns and persistent loss of taste or
smell (Collins, April 28, 2021). The cause of these long-term effects
and effective treatments have yet to be established. The report from
the Pulmonary Breakout Session of the National Institute of Allergy and
Infectious Diseases (NIAID) Workshop on Post-Acute Sequelae of COVID-19
stated that the ``burden of post-acute sequelae overall could be
enormous'' (NIAID, December 4, 2020). Dr. John Brooks, the chief
medical officer for the CDC's COVID-19 response, said he expected long-
term symptoms would affect ``on the order of tens of thousands in the
United States and possibly hundreds of thousands'' (Belluck, December
5, 2020). Dr. Collins testified that longer-term health impairments may
occur in up to 30% of recovered COVID-19 patients (Collins, April 28,
2021).
Prolonged illness is common in patients who required
hospitalization because of COVID-19, and particularly in those who
required ICU admission. In a large nationwide U.S. study, 18.5% of
hospitalized patients were discharged to a long-term care or
rehabilitation facility (Rosenthal et al., December 10, 2020). Of 1,250
patients in a Michigan study, 12.6% were discharged to a skilled
nursing or rehabilitation facility and 15.1% of hospital survivors were
re-hospitalized within 60 days of discharge (Chopra et al., November
11, 2020). Of the 195 who were employed prior to hospitalization, 23%
were unable to return to work due to health reasons and 26% of those
who returned to work required reduced hours or modified duties (Chopra
et al., November 11, 2020). Those who returned to work did so a median
of 27 days after hospital discharge (Chopra et al., November 11, 2020).
Existing evidence indicates that COVID-19 patients requiring ICU care
and mechanical ventilation may experience Post Intensive Care Syndrome
(PICS), which is a constellation of cognitive dysfunction, psychiatric
conditions, and/or physical disability that persists after patients
leave the ICU (Society of Critical Care Medicine, 2013). In a study at
3 months post-discharge of 19 COVID-19 patients who required mechanical
ventilation while hospitalized, 89% reported pain or discomfort, 47%
experienced decreased mobility, and 42% experienced anxiety/depression
(Valent, October 10, 2020). The authors noted that these results are
similar to those reported in follow-up studies of patients who survived
ARDS due to other viral infections. Many employees hospitalized with
COVID-19 may require a long period of recovery should this trajectory
continue to hold. In a 5-year follow-up of 67 previously-employed ARDS
survivors, 34 had not returned to work within one year of discharge and
21 had not returned at five years (Kamdar, February 1, 2018). ARDS is a
serious complication that may have an impact on employees' ability to
return to work after a COVID-19 diagnosis.
Several studies conducted outside the U.S. have also noted the
persistence of COVID-19 symptoms after hospital discharge. In a study
of 1,733 discharged patients in China, 76% reported at least one
symptom of COVID-19 six months after hospital discharge with 63%
experiencing persistent fatigue or muscle weakness (Huang et al.,
January 8, 2021). Similarly, an Irish study found 52% of 128 patients
reported persistent fatigue a median of 10 weeks after initial symptoms
first appeared (Townsend et al., November 9, 2020). A study of 991
pregnant women (5% hospitalized) in the U.S. found that the median time
for symptoms to resolve was 37 days and that 25% had persistent
symptoms (mainly cough, fatigue, headache, and shortness of breath)
eight weeks after onset (Afshar et al., December, 2020). A study of 86
previously-hospitalized Austrian patients observed that 88% had CT
scans still indicating lung damage at 6 weeks after their hospital
discharge; at 12 weeks, 56% of CT scans still revealed damage (European
Respiratory Society, September 7, 2020). A study of 152 previously-
hospitalized patients with laboratory-confirmed COVID-19 disease who
required at least 6 liters of oxygen during admission found that 30 to
40 days after discharge, 74% reported shortness of breath and 13.5%
still required oxygen at home (Weerahandi et al., August 14, 2020). A
UK study found that among 100
hospitalized patients (32% required ICU care), 72% of the ICU patients
and 60% of the non-ICU patients reported fatigue a mean of 48 days
after discharge (Halpin et al., July 27, 2020). Breathlessness was also
common, affecting 65.6% of ICU patients and 42.6% of non-ICU patients.
In a New York City study, of the 638 COVID-19 patients who required
dialysis for AKI while hospitalized, only 108 survived. Of those 108,
33 still needed dialysis at discharge (Ng et al., September 19, 2020).
A study of Chinese patients reported that 11% of 333 hospitalized
patients with COVID-19 pneumonia developed AKI (Pei et al., June,
2020). Only half (45.7%) experienced complete recovery of kidney
function with a median follow up of 12 days. A similar study in Spain
also found only half (45.72%) experienced complete recovery with a
median follow up of 11 days (Procaccini et al., February 14, 2021). A
Hong Kong study provided a longer follow-up period including 30 and 90
days after the initial AKI event. At 7, 30, and 90 days after the
initial AKI event, recovery was observed in 84.6, 87.3% and 92.1%,
respectively (Teoh et al., 2021). A study in New York City found that
77.1% of patients with AKI experienced complete recovery during the
follow up period, excluding those who died or were sent to hospice
(Charytan et al., January 25, 2021). While 88% of these AKI cases were
in March and April with a final follow-up date of August 25, it is
uncertain how long it took for recovery to occur.
Long-term cardiovascular effects also appear to be common after
SARS-CoV-2 infections, even among those who did not require hospital
care. A German study evaluated the presence of myocardial injury in 100
patients a median of 71 days after COVID-19 diagnosis (Puntmann et al.,
July 27, 2020). While only a third (33%) of study participants required
hospitalization, cardiovascular magnetic resonance (CMR) imaging was
abnormal in 78%. In the U.S., a study of COVID-19 cases in college
athletes, of whom 16 of 54 (30%) were asymptomatic, identified abnormal
findings in 27 (56.3%) of the 48 athletes who completed both imaging
studies, with 39.5% consistent with resolving pericardial inflammation
(Brito et al., November 4, 2020). A small number remained symptomatic
with fatigue and shortness of breath at 5 weeks and were referred to
cardiac rehabilitation (Lowry, November 12, 2020).
A database for clinicians in the UK to report COVID-19 patients
with neurological complications revealed that 62% of the initial 125
patients enrolled presented with a cerebrovascular event including
ischemic strokes and intracerebral hemorrhages (Varatharaj et al., June
25, 2020). A UK study comparing COVID-19 ischemic stroke and
intracerebral cases with similar non-COVID-19 cases found a fatality
rate of 19.8% for COVID-19 patients in comparison to a fatality rate of
6.9% for non-COVID-19 patients (Perry et al., 2021). As discussed
above, PICS, involving prolonged impairments in cognition, physical
health, and/or mental health, may also occur. Other neurologic
diagnoses, including encephalopathy, Guillain-Barre syndrome, and a
range of other less-common diagnoses, may cause morbidity that persists
during recovery (Elkind et al., April 9, 2021; Sharifian-Dorche et al.,
August 7, 2020). A recent autopsy study of brain tissue from 18 COVID-
19 patients reported the presence of small blood vessel inflammation
and damage in multiple different brain areas (Lee et al., February 4,
2021). Persistent abnormalities in brain imaging have also been
reported in patients after discharge (Lu et al., August 3, 2020). A
study of 509 hospitalized patients in the Chicago area early in the
pandemic reported that a third had encephalopathy, resulting in
symptoms such as confusion or decreased levels of consciousness (Liotta
et al., October 5, 2020). Encephalopathy was associated with worse
functional outcomes at discharge (only 32% were able to handle their
own affairs without assistance) and higher deaths in the 30 days post-
discharge.
COVID-19 also impacts mental health, both as a result of the toll
of living and working through such a disruptive pandemic, but also
because of actual medical impacts the virus might have on the brain
itself. As de Erausquin et al., (January 5, 2021) notes, SARS-CoV-2 is
a suspected neurotropic virus and ``neurotropic respiratory viruses
have long been known to result in chronic brain pathology including
emerging cognitive decline and dementia, movement disorders, and
psychotic illness. Because brain inflammation accompanies the most
common neurodegenerative disorders and may contribute to major
psychiatric disorders, the neurological and psychiatric sequelae of
COVID[hyphen]19 need to be carefully tracked.'' An international
consortium guided by WHO is attempting to determine these long-term
neurodegenerative consequences more definitively, with follow up
studies ending in 2022 (de Erausquin et al., January 5, 2021).
In the short term, a number of studies have already demonstrated
the potential mental health effects caused by COVID-19. In the UK
database mentioned above, 21 of 125 COVID-19 patients had new
psychiatric diagnoses, including 10 who became psychotic and others
with dementia-like symptoms or depression (Varatharaj et al., June 25,
2020). An Italian study screened 402 adults with COVID-19 for
psychiatric symptoms with clinical interviews and self-report
questionnaires at one month follow-up after hospital treatment for
COVID-19. Patients rated in the psychopathological range as follows:
28% for post-traumatic stress disorder (PTSD), 31% for depression, 42%
for anxiety, 20% for obsessive-compulsive symptoms, and 40% for
insomnia. Overall, 56% scored in the pathological range in at least one
clinical dimension (Mazza et al., July 30, 2020). The TriNetX analytics
network was used to capture de-identified data from electronic health
records of a total of 69.8 million patients from 54 healthcare
organizations in the United States (Taquet et al., November 9, 2020).
Of those patients, 62,354 adults were diagnosed with COVID-19 between
January 20 and August 1, 2020. Within 14 to 90 days after being
diagnosed with COVID-19, 5.8% of those patients received a first
recorded diagnosis of psychiatric illness, which was measured as
significantly greater than psychiatric onset incidence during the same
time period after diagnoses of other medical issues including influenza
(2.8%), other respiratory diseases (3.4%), skin infections (3.3%),
cholelithiasis (3.2%), urolithiasis (2.5%), and fractures (2.5%). At
the NIAID Workshop on Post-Acute Sequelae of COVID-19, medical
personnel discussed their experiences treating COVID-19 patients in the
Johns Hopkins Post-Acute COVID-19 Team (PACT) Clinic. Among 49 patients
in the Clinic, more than 50% had some form of cognitive impairment 3
months after acute illness (Parker, December 3, 2020). Both ICU and
non-ICU patients were affected, but impairment was more pronounced in
ICU survivors (Parker, December 3, 2020). The medical personnel also
reported mental health impairments among patients treated at the PACT
Clinic.
The studies and evidence discussed above give some indication of
the many serious long-term health effects COVID-19 patients might
experience, including respiratory, cardiovascular, neurological, and
psychiatric complications. However, the full extent of the long-term
health consequences of COVID-19 is unknown because the
virus has only been transmitted between humans since the end of 2019.
Therefore, to fully appreciate the likely long-term risks to
individuals with COVID-19, it is important to consider the long-term
impacts of similar coronaviruses found among human populations where
there has been more time to gather data.
The previous SARS outbreak in 2002 to 2003, caused by the SARS-CoV-
1 virus, is one such example, and it indicates long-term impacts to
infection survivors, which might result from the viral infection,
medications used, or a combination of those factors. Patients who
survived a SARS-CoV-1 infection report that they have a reduced quality
of life at least 6 months after illness (Hui et al., October 1, 2005).
These patients were found to have reduced exercise capacity; some had
abnormal chest radiographs and lung function, and weak respiratory
muscles at least 6 months after illness (Hui et al., October 1, 2005).
Survivors reported experiencing depression, insomnia, anxiety, PTSD,
chronic fatigue, and decreased lung capacity with patient follow up as
long as four years after infection (Lam et al., December 14, 2009; Lee
et al., April 1, 2007; Hui et al., October 1, 2005). Long term studies
have revealed that some survivors of SARS-CoV-1 infections have chronic
pulmonary and skeletal damage after a 15 year follow up (Zhang et al.,
February 14, 2020). Zhang et al., found that approximately half of the
area of ground glass opacities present after infection in a 2003 CT
scan (9.4%) remained after 15 years (4.6%). The study also found
significant femoral head loss (25.52%) remained in 2018. Bone loss was
likely an indirect effect caused by the high pulse steroid therapies
used to treat the infection in many patients with severe disease.
Survivors also suffer long-term neurologic complications, deficits in
cognitive function, musculoskeletal pain, fatigue, depression, and
disordered sleep up to at least three years after infection (Moldofsky
and Patcai, March 24, 2011).
Individuals at Increased Risk From COVID-19
Many members of the workforce are at increased risk of death and
severe disease from COVID-19 because of their age or pre-existing
health conditions. Comorbidities are fairly common among adults of
working age in the U.S. For instance, 46.1% of individuals with cancer
are in the 20-64 year old age range (NCI, April 29, 2015), and over 40%
of working age adults are obese (Hales et al., February 2020).
Furthermore, over a quarter of those between 65 and 74 years old remain
in the workforce, as well as almost 10% of those 75 and older (BLS, May
29, 2019). In hospitals and other health services (e.g., physician
offices, residential care facilities), 1,078,000 workers are employed
who are 65 years old and older (BLS, January 22, 2021). Individuals who
are at increased risk of severe infection (hospitalization, admission
to the ICU, or death) include: Individuals who have cancer, chronic
kidney disease, chronic lung disease (e.g., chronic obstructive
pulmonary disease (COPD), asthma (moderate-to-severe), interstitial
lung disease, cystic fibrosis, and pulmonary hypertension), serious
heart conditions, obesity, pregnancy, sickle cell disease, type 2
diabetes, and individuals who are over 65 years of age,
immunocompromised and/or smokers (CDC, May 13, 2021). Of 5,700 COVID-19
patients hospitalized from March 1 to April 4, 2020 in the New York
City area, the most common comorbidities were hypertension (56.6%),
obesity (41.7%), and diabetes (33.8%), excluding age (Richardson et
al., April 22, 2020).
Observed Disparities in Risk Based on Race and Ethnicity
During the COVID-19 pandemic, research has found that employees in
racial and ethnic minority groups, and especially Black and Latinx
employees, have often faced substantially higher risks of SARS-CoV-2
exposure and infection through the workplace than have non-Hispanic
White employees (Hawkins, June 15, 2020; Hertel-Fernandez et al., June
2020; Roberts et al., November 26, 2020). Among the general U.S.
population, American Indian, Alaskan Native, Latinx, and Black
populations are more likely than White populations to be infected with
SARS-CoV-2 (CDC, April 23, 2021). Once infected, people in these
demographics are also more likely than their White counterparts to be
hospitalized for and/or die from COVID-19 (CDC, April 23, 2021). These
observed disparities in risk of infection, risk of adverse health
consequences, and risk of death may be attributable to a number of
factors, including that people from racial and ethnic minority groups
are often disproportionately represented in essential frontline
occupations that require close contact with the public and that offer
limited ability to work from home or take paid sick days. Disease
severity is also likely exacerbated by long-standing healthcare
inequities (CDC, April 19, 2021).
Hawkins (June 15, 2020) compared data on worker demographics from
the Bureau of Labor Statistics' 2019 Current Population Survey and
O*NET (a Department of Labor database that contains detailed
occupational information on the nature of work for more than 900
occupations across the U.S.) to determine occupation-specific COVID-19
risks. The model found that among O*NET's 57 physical and social
factors related to work, the two predictive variables of COVID-19 risk
were frequency of exposure to diseases and physical proximity to other
people. The author found that Black individuals were overwhelmingly
employed in essential industries and that people of color--which in
this study included Black, Asian, and Hispanic populations--were more
likely than White individuals to work in essential occupations (e.g.,
healthcare and social assistance, personal care aids) that were
identified as having greater disease exposure risk characteristics. A
similar evaluation of workers employed in frontline industries (e.g.,
healthcare) found that people of color--defined in this study to
include individuals who are Black, Hispanic, Asian-American/Pacific
Islander, or some category other than White--are well represented in
these types of work (Rho et al., April 7, 2020). These studies suggest
that people in racial and ethnic minority groups are greatly
represented among the American workforce in jobs associated with
greater risk of exposure to SARS-CoV-2, including those in healthcare
and related industries.
Through April 2021, infection rates compared to White, Non-Hispanic
persons in the United States are 60% greater for American Indian or
Alaskan Native persons, 100% greater for Latinx persons, and 10%
greater for Black persons (CDC, April 23, 2021). This disparity is also
reflected in studies addressing infections by occupation, race, and
ethnicity. In a large study of healthcare employees in Los Angeles,
researchers found that increased risk of infection was significantly
related to whether an employee was Latinx or Black (Ebinger et al.,
February 12, 2021). Another study of frontline healthcare workers in
the U.S. and UK found that Black, Asian, and minority ethnic workers
were more likely to report a positive COVID-19 test than non-Hispanic,
White workers (Nguyen et al., September 1, 2020). The study also found
that Black, Asian, and minority ethnic healthcare workers were more
likely to report reuse of or inadequate PPE, were more likely to work
in higher-risk clinical settings (e.g., in-patient hospitals or nursing
homes), and were more likely to care for patients with
suspected or documented COVID-19. These studies illustrate that racial
and ethnic minorities are likely to be at increased risk of
occupational SARS-CoV-2 exposures and related infections.
In addition to an increased likelihood of exposures and potential
infection, Native American, Alaskan Native, Latinx, and Black
populations all have increased risk of hospitalization and/or death
from COVID-19 in comparison to White populations (CDC, April 23, 2021).
Chen et al., (January 22, 2021) studied increased mortality risk
between different racial and ethnic minority groups and occupations for
working age Californians in pre-pandemic and pandemic time frames.
Measured mortality risks increased during the pandemic for all races
and ethnicities, but White populations had lower increased risk (6%
increase) compared to Asian populations (18%), Black populations (28%)
and Latinx populations (36%). A similar disparity in excess mortality
was also observed between races and ethnicities within the same
occupational sector (Chen et al., January 22, 2021). In the ``health or
emergency'' sector, risk ratios were far greater for Asian (1.40),
Black (1.27), and Latinx (1.32) workers in comparison to White workers
(1.02).
Health equity is a major concern in assessing the pandemic's
effects (CDC, April 19, 2021). Some of the factors that contribute to
increased risk of morbidity and mortality from COVID-19 include:
Discrimination, healthcare access/utilization, economic issues, and
housing (CDC, April 23, 2021). And although racial and ethnic minority
groups are more likely to be exposed to and infected with SARS-CoV-2,
research indicates that testing for the virus is not markedly higher
for these demographic groups (Rubin-Miller et al., September 16, 2020).
Rubin-Miller et al., note that there may be barriers to testing that
decrease access or delay testing to a greater degree than in White
populations. These barriers to testing can delay needed medical care
and lead to worse outcomes. And even when able to seek care, other
barriers may exist. In discussing widespread health inequities, studies
have noted that American Indian communities lacked sufficient
facilities to respond to COVID-19 (Hatcher et al., August 28, 2020; van
Dorn et al., April 18, 2020).
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b. Transmission of SARS-CoV-2
SARS-CoV-2 is a highly transmissible virus. Since the first case
was detected in the U.S., there have been over 32 million reported
cases of COVID-19, affecting every state and territory, with thousands
more infected each day. According to the CDC, the primary way the SARS-
CoV-2 virus spreads from an infected person to others is through the
respiratory droplets that are produced when an infected person coughs,
sneezes, sings, talks, or breathes (CDC, May 7, 2021).\8\ Infection
could then occur when another person breathes in the virus. Most
commonly this occurs when people are in close contact with one another
in indoor spaces (within approximately six feet for at least fifteen
minutes) (CDC, May, 2021).
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\8\ On May 7, 2021, the CDC updated its guidance regarding
airborne transmission (CDC, May 7, 2021; https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2-transmission.html). OSHA notes that this change does not alleviate
the need for any of the controls in this ETS. Because OSHA has
determined that the controls in this ETS are necessary to address a
grave danger as quickly as possible, the agency determined that it
was appropriate to issue the ETS while it continues to evaluate the
new evidence to determine whether additional controls may be
necessary at a later date.
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The best available current scientific evidence demonstrates that
the farther a person is away from the source of the respiratory
droplets, the fewer infectious viral particles will reach that person's
eyes, nose, or mouth because gravity pulls the droplets to the ground
(see the Need for Specific Provisions, Section V of the preamble, on
Physical Distancing). For example, a systematic review of SARS-CoV-2
(up to early May 2020) and similar coronaviruses (i.e., SARS-CoV-1 (a
virus related to SARS-CoV-2) and Middle Eastern Respiratory Syndrome
(MERS) (a disease caused by a virus that is similar to SARS-CoV-2 and
spreads through droplet transmission)) found 38 studies, containing
18,518 individuals, to use in a meta-analysis that found that the risk
of viral infection decreased significantly as distance increased (Chu
et al., June 27, 2020). A second COVID-19 study from Thailand reviewed
physical distancing information collected from 1,006 individuals who
had an exposure to infected individuals (Doung-ngern et al., September
14, 2020). The study revealed that the group with direct physical
contact and the group within one meter but without physical contact
were equally likely to become infected with SARS-CoV-2. However, the
group that remained more than one meter away had an 85% lower infection
risk than the other two groups. The studies' findings on physical
distancing combined with expert opinion firmly establish the importance
of droplet transmission as a driver of SARS-CoV-2 infections and COVID-
19 disease.
COVID-19 may also be spread through airborne particles under
certain conditions (Schoen, May 2020; CDC, May 7, 2020; Honein et al.,
December 11, 2020). That airborne transmission can occur during
aerosol-generating procedures (AGPs) in healthcare (such as when
intubating an infected patient) is a reasonable concern (see CDC, March
12, 2020). CDC provides recommendations for infection prevention and
control practices when caring for a patient with suspected or confirmed
SARS-CoV-2 infection that include the use of a respirator (CDC,
February 23, 2021). There are several studies examining the risks
associated with AGPs. For example, a publication detailing one of the
first known SARS-CoV-2 occupational transmission events in U.S.
healthcare providers reported a statistically significant increased
risk from AGPs (Heinzerling et al., April 17, 2020). However, the
currently available information specifically related to SARS-CoV-2
exposure during AGPs is limited (Harding et al., June 1, 2020).
Data from the Respiratory Protection Effectiveness Trial (ResPECT),
designed to assess effectiveness of PPE to prevent respiratory
infections, were analyzed to identify risk factors for endemic
coronavirus infections among healthcare personnel (Cummings et al.,
July 9, 2020). This study found that AGPs may double the risk of
infection among healthcare providers. Although the infectious agents
studied were surrogate coronaviruses and not the SARS-CoV-2 virus, the
study indicates increased risk from such procedures for infections from
the coronavirus family, and thus the study is relevant. In addition, a
systematic review of research on transmission of acute respiratory
infections from patients to healthcare employees focused on
publications from the first SARS virus outbreak (Tran et al., April 26,
2012). Risks of SARS-CoV-1 infection in those performing AGPs were
several times higher than in healthcare workers not exposed to AGPs.
Workers may also be exposed to the SARS-CoV-2 virus during AGPs
conducted outside of the hospital setting, including certain dental
surgical procedures (Leong et al., December 2020), cardiopulmonary
resuscitation (CPR) provided by homecare workers (Payne and Peache,
February 4, 2021), and endoscopy (Teng et al., September 16, 2020;
Sagami et al., January 2021).
Risk from AGPs during autopsies is evident from reports of staff
infections during autopsies on decedents infected with tuberculosis,
which is a well-known airborne infectious agent (Nolte et al., December
14, 2020). Additionally, research that measured airborne particles
released during the use of an oscillating saw with variable saw blade
frequencies and different saw blade contact loads concluded that, even
in the best-case scenario tested on dry bone, the number of aerosol
particles produced was still high enough to provide a potential health
risk to forensic practitioners (Pluim et al., June 6, 2018). Other
reports from healthcare settings have raised the possibility of spread
of airborne particles from suspected or confirmed COVID-19 patients,
absent AGPs. For example, infectious viral particles were collected
from in the room of a COVID-19 patient from distances as far as 4.8
meters away in non-AGP hospital settings (Lednicky et al., September
11, 2020), and transmission via aerosol was suspected in a
Massachusetts hospital (Klompas et al., February 9, 2021). For more
discussion of this subject, see the Need for Specific Provisions
(Section V of the preamble) on Respirators.
The extent to which COVID-19 may spread through airborne particles
in other contexts is less clear. CDC has noted that in some
circumstances airborne particles can remain suspended in the air and be
breathed in by others, and travel distances beyond 6 feet (for example,
during choir practice, in restaurants, or in fitness classes) in
situations that would not be defined as involving close contact:
With increasing distance from the source, the role of inhalation
likewise increases. Although infections through inhalation at
distances greater than six feet from an infectious source are less
likely than at closer distances, the phenomenon has been repeatedly
documented under certain preventable circumstances. These
transmission events have involved the presence of an infectious
person exhaling virus indoors for an extended time (more than 15
minutes and in some cases hours) leading to virus concentrations in
the air space sufficient to transmit infections to people more than
6 feet away, and in some cases to people who have passed through
that space soon after the infectious person left.
(CDC, May 7, 2021).
In general, enclosed environments, particularly those without good
ventilation, increase the risk of airborne transmission (CDC, May 7,
2021; Tang et al., August 7, 2020; Fennelly, July 24, 2020). In one
scientific brief, CDC provides a basic overview of how airborne
transmission occurs in indoor spaces. Once respiratory droplets are
exhaled, CDC explains, they move outward from the source and their
concentration decreases through fallout from the air (largest droplets
first, smaller later) combined with dilution of the remaining smaller
droplets and particles into the growing volume of air they encounter
(CDC, May 7, 2020). Without adequate ventilation, continued exhalation
can cause the amount of infectious smaller droplets and particles
produced by people with COVID-19 to become concentrated enough in the
air to spread the virus to other people (CDC, May 7, 2020). For
example, an investigation of a cluster of cases among meat processing
employees in Germany found that inadequate ventilation within the
facility, including low air exchange rates and constant air
recirculation, was one key factor that led to transmission of SARS-CoV-
2 within the workplace (Gunther et al., October 27, 2020). An
epidemiological investigation of a cluster of COVID-19 cases in an
indoor athletic court in Slovenia demonstrated that the humid and warm
environment of the setting, combined with the turbulent air flow that
resulted from the physical activity of the players, allowed COVID-19
particles to remain suspended in the air for hours (Brlek et al., June
16, 2020). A cluster of cases in a restaurant in China also suggested
transmission of SARS-CoV-2 via airborne particles because of little
mixing of air throughout the restaurant (Li et al., November 3, 2020).
Infections have been observed with as little as five minutes of
exposure in an enclosed room (Kwon et al., November 23, 2020). Outdoor
settings (i.e., open air or structures with one wall) typically have a
lower risk of transmission (Bulfone et al., November 29, 2020), which
is likely due to increased ventilation with fresh air and a greater
ability to maintain physical distancing. For more discussion of this
subject, see the Need for Specific Provisions (Section V of the
preamble) on Ventilation.
Transmission of SARS-CoV-2 is also possible via contact
transmission (both direct contact as well as surface contact), though
this risk is generally considered to be low compared to other forms of
transmission (CDC, April 5, 2021). Infectious droplets produced by an
infected person can land on and contaminate surfaces. Surface, or
indirect, transmission can then occur if another person touches the
contaminated surface and then touches their own mouth, nose, or eyes
(CDC, April 5, 2021). Contact transmission can also occur through
direct contact with someone who is infectious. In direct contact
transmission, the hands of a person who has COVID-19 can become
contaminated with the virus when the person touches their face, blows
their nose, coughs, or sneezes. The virus can then spread to another
person through direct contact such as a handshake or a hug.
The risk posed by contact transmission depends on a number of
factors, including airflow and ventilation, as well as environmental
factors (e.g., heat, humidity), time between surface contamination and
a person touching those surfaces, the efficiency of transference of
virus particles, and the dose of virus needed to cause infection.
Studies show that the virus can remain viable on surfaces in
experimental conditions for hours to days, but that under typical
environment conditions 99% of the virus is no longer viable after three
days (Riddell et al., October 7, 2020; van Doremalen, April 16, 2020;
CDC, April 5, 2021). At this time, it is not clear what proportion of
SARS-CoV-2 infection are acquired through contact transmission and
infections can often be attributed to multiple transmission pathways.
In recognition of the potential for contact transmission, CDC
recommends cleaning, hand hygiene, and, under certain circumstances,
disinfection for helping to prevent transmission of SARS-CoV-2 (CDC,
May 17, 2020; CDC, April 5, 2021). These are long established
recommendations to prevent the transmission of viruses that cause
respiratory illnesses (Siegel et al., 2007). The potential for contact
transmission was demonstrated in one study that reviewed cleaning and
disinfection in households (Wang et al., May 11, 2020). The study found
that the transmission of SARS-CoV-2 to family members was 77% lower
when chlorine- or ethanol-based disinfectants were used on a daily
basis compared to use only once in two or more days, irrespective of
other protective measures taken such as mask wearing and physical
distancing. For more discussion of this subject, see the Need for
Specific Provisions (Section V of the preamble) on Cleaning and
Disinfection.
These methods of transmission are not mutually exclusive, and each
can present a risk to employees in healthcare settings. Based on these
methods of transmission, there are a number of factors--often present
in healthcare settings--that can increase the risk of transmission:
Indoor settings, prolonged exposure to respiratory particles, and lack
of proper ventilation (CDC, May 7, 2020). First, and most
significantly, healthcare employees in settings where patients with
suspected or confirmed COVID-19 receive treatment may be required to
have frequent close contact with infectious individuals, these settings
are typically not designed for physical distancing, and many areas in
these facilities are not ventilated for the purpose of minimizing
infectious diseases capable of droplet or airborne transmission.
Employees frequently touch shared surfaces and use shared items. Even
in healthcare settings where employees have their own offices or
equipment, they often share a number of common spaces with other
workers, including bathrooms, break rooms, and elevators. Based on
these characteristics, SARS-CoV-2 appears to be transmissible in
healthcare environments, a conclusion supported by existing data
(Howard, May 22, 2021). COVID-19 incidence rates have increased
significantly for adults of working age as the pandemic has progressed
in comparison with other age groups, with researchers noting that
occupational status might be a driver (Boehmer et al., September 23,
2020). Currently, case rates continue to be predominantly higher in
working age groups in comparison to children and those over the age of
65 (CDC, May 24, 2021).
Given the high transmissibility expected in healthcare
environments, the exposure risk that employees face is high. This risk
is related to some extent to viral prevalence, which refers to the
number of individuals in healthcare settings who may be infectious at
any moment. As explained below, current data indicates that viral
prevalence in the population is based on a number of factors, including
the virus's existing reproductive number, the prevalence of pre-
symptomatic and asymptomatic transmission, and the recent documentation
of mutations of the virus that appear to be more infectious.
The transmissibility of viruses is measured in part by their
reproductive number or ``R0.'' This number represents the average
number of subsequently-infected people (or secondary cases) that are
expected to occur from each existing case, which includes low
transmission events as well as super-spreading phenomenon. Thus, an R0
of ``1'' indicates that on average every one case of infection will
lead to one additional case. As long as a virus has an R0 of more than
1, it is expected to continue to spread throughout the population. The
observed R0 (also known as simply R) must be below 1 to prevent
sustained spread; such a reduction can be achieved through infection
control interventions (e.g., vaccination, non-pharmaceutical
interventions) that either reduce the susceptibility of the population
to the virus or reduce the likelihood of transmission within the
population (Delamater et al., 2019). During the early part of the
COVID-19 outbreak in China, before consistent protective measures were
put into place, the R0 for SARS-CoV-2 was estimated as 2.2 (Riou and
Althaus, January 30, 2020). Higher estimates of the R0 early in China
(5.7) have also been published (Sanche et al., April 7, 2020). R0
ranges from 2 to 5 have been published for earlier MERS and SARS-CoV-1
coronavirus outbreaks (WHO, May 2003; Choi et al., September 25, 2017).
Since the start of the COVID-19 pandemic, the R0 has varied depending
on the natural ebb and flow of rolling infection surges as well as the
fluctuating non-pharmaceutical interventions (NPIs) put in place, such
as face coverings, nonessential business shutdowns, and testing with
follow-up isolation and quarantining. The R0 value in the U.S. early in
the pandemic was estimated to be approximately 2 (Li et al., October
22, 2020), and this value has generally remained above 1 for the
country as a whole throughout the pandemic, with various states well
above and below this value at various times (Harvard Chan School of
Public Health, February 26, 2021; Shi et al., May 18, 2021).
Pre-symptomatic and asymptomatic transmission are significant
drivers of the continued spread of COVID-19 (Johansson et al., January
7, 2021). Individuals are considered most infectious in the 48 hours
before experiencing symptoms and during the first few symptomatic days
(Cevik et al., October 23, 2020). The time it takes for a person to be
infected and then transmit the virus to another individual is called
the serial interval. Several studies have indicated that the serial
interval for COVID-19 is shorter than the time for symptoms to develop,
meaning that many individuals can transmit SARS-CoV-2 before they begin
to feel ill (Nishiura et al., March 4, 2020; Tindale et al., June 22,
2020). It is also possible for individuals to be infected and
subsequently transmit the virus without ever exhibiting symptoms. This
is called asymptomatic transmission. As noted earlier, a recent meta-
analysis reviewed 13 studies in which the asymptomatic prevalence
ranged from 4% to up to 41% (Byambasuren et al., December 11, 2020).
The existence of both pre-symptomatic transmission and asymptomatic
infection and transmission pose serious challenges to containing the
spread of the virus. Although the risk of asymptomatic transmission is
42% lower than from symptomatic COVID-19 patients (Byambasuren et al.,
December 11, 2020), asymptomatic transmission may result in more
transmissions than symptomatic cases, perhaps because asymptomatic
persons are less likely to be aware of their infection and can
unknowingly continue to spread the disease to others. Similarly, pre-
symptomatic individuals can transmit the virus to others before they
know they are sick and should isolate, assuming they are aware of their
exposure. Existing evidence demonstrates that asymptomatic transmission
is a significant contributor to the spread of COVID-19 in the United
States. Johansson et al., (January 7, 2021) conducted a study to assess
the proportion of SARS-CoV-2 transmission from pre-symptomatic, never
symptomatic, and symptomatic individuals in the community. Based on
their modeling, they found 59% of transmission came from asymptomatic
transmission, including 35% from pre-symptomatic individuals and 24%
from individuals who never develop symptoms (Johansson et al., January
7, 2021).
The SARS-CoV-2 virus also regularly mutates over time into
different genetic variants. Many of these variants results in no
increase in transmission or disease severity. However, the CDC monitors
for variants of interest, variants of concern, and variants of high
consequence (CDC, May 5, 2021). A variant of interest is one ``with
specific genetic markers that have been associated with changes to
receptor binding, reduced neutralization by antibodies generated
against previous infection or vaccination, reduced efficacy of
treatments, potential diagnostic impact, or predicted increase in
transmissibility or disease severity'' (CDC, May 5, 2021). CDC-listed
variants of interest include strains first identified in the United
States (e.g., B.1.526, B.1.526.1), the United Kingdom (e.g., B.1.525),
and Brazil (e.g., P.2). A variant of concern is one for which there is
``evidence of an increase in transmissibility, more severe disease
(e.g., increased hospitalizations or deaths), significant reduction in
neutralization by antibodies generated during previous infection or
vaccination, reduced effectiveness of treatments or vaccines, or
diagnostic detection failures'' (CDC, May 5, 2021). CDC-listed variants
of concern include strains first identified in the United States (e.g.,
B.1.427, B.1.429), United Kingdom (e.g., B.1.17), Brazil (e.g., P.1),
and South Africa (e.g., B.1.351). As of April 24, B.1.1.7 made up 60%
of infections in the United States (CDC, May 11, 2021). CDC notes that
B.1.1.7 is associated with a 50% increase in transmission, as well as
potentially increased incidence of hospitalizations and fatalities
(CDC, May 5, 2021). As new strains with increased transmissibility or
more severe effects enter the U.S. population, healthcare workers may
be among the first to be exposed to them when those who are infected
seek medical care (Howard, May 22, 2021).
OSHA also recognizes that reported cases of SARS-CoV-2 likely
undercount actual infections in the U.S. population. This finding is
based on seroprevalence data, which measure the presence of specific
antibodies in the blood that are typically developed when an individual
is infected with SARS-CoV-2. Reported cases, in contrast, are based on
COVID-19 tests that measure active infections. Recent reported case
numbers suggest that approximately 10% of the US population has been
infected. However, only seven states reported seroprevalence below 10%
(i.e., Alaska, Hawaii, Maine, New Hampshire, Oregon, Vermont,
Washington) and 23 states plus Washington DC and Puerto Rico exceeded
20% (CDC, May 14, 2021). The likely reason for this difference is that
serological tests measure antibodies in the blood that can be detected
for a longer period of time than can an active COVID-19 infection. As
such, serological testing may be able to detect past COVID-19
infections in individuals who never sought out a viral test. A sampling
of states from the Nationwide Commercial Laboratory Seroprevalence
Survey illustrates this (CDC, May 14, 2021). On March 30, 2021,
California had reported 3,564,431 cases, but seroprevalence estimates
indicate that there have been 7,986,000 cases in the state (95% CI:
7,023,000-8,965,000). Similarly, Texas has reported 2,780,903 cases,
but seroprevalence data indicate 6,692,000 cases (95% CI: 5,624,000-
7,819,000). Given the very real possibility of higher numbers of cases
than are reported in national case counts, the disease burden discussed
in this document may well be underestimated.
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(WHO, May 2003)
c. The Effect of Vaccines on the Grave Danger Presented by SARS-CoV-2
The development of safe and highly effective vaccines and the on-
going nation-wide distribution of these vaccines are encouraging
milestones in the nation's response to COVID-19. Although there was
initial uncertainty attached to the performance of authorized vaccines
outside of clinical trials, vaccines have been in use for several
months and they have proven effective in reducing transmission as well
as the severity of COVID-19 cases. Data now available clearly establish
that fully-vaccinated persons (defined as two weeks after the second
dose of the mRNA vaccines or two weeks after the single dose vaccine)
have a greatly reduced risk compared to unvaccinated individuals. This
includes reductions in deaths, severe infections requiring
hospitalization, and less severe symptomatic infections. The
combination of data from clinical trials and data from mass vaccination
efforts points increasingly to a significantly lower risk in settings
where all workers are fully vaccinated and are not providing direct
care for individuals with suspected or confirmed COVID-19. OSHA has
therefore determined that there is insufficient evidence in the record
to support a grave danger finding for employees in non-healthcare
workplaces (or discrete segments of workplaces) where all employees are
vaccinated. However, in healthcare settings where workers are
vaccinated, as discussed below, the best available evidence establishes
a grave danger still exists, given the greater potential for
breakthrough cases in light of the greater frequency of exposure to
suspected and confirmed COVID-19 patients in those settings (Birhane et
al., May 28, 2021). In addition, the best available evidence shows that
vaccination has not eliminated the grave danger in mixed healthcare
workplaces (i.e., those where some workers are fully vaccinated and
some are unvaccinated) or in those healthcare workplaces where no one
has yet been vaccinated.
The Effectiveness of Authorized Vaccines
There are currently three vaccines for the prevention of COVID-19
that have received EUAs from the FDA, allowing for their distribution
in the U.S.: The Pfizer-BioNTech COVID-19 vaccine, the Moderna COVID-19
vaccine, and the Janssen COVID-19 vaccine. Pfizer-BioNTech and Moderna
are mRNA vaccines that require two doses administered three weeks and
one month apart, respectively. Janssen is a viral vector vaccine that
requires a single dose (CDC, April 2, 2021). The vaccines were shown to
greatly exceed minimum efficacy standards in preventing COVID-19 in
clinical trial participants (FDA, December 11, 2020; FDA, December 18,
2020; FDA, February 26, 2021). Data from clinical trials for all three
vaccines and observational studies for the two mRNA vaccines clearly
establish that fully vaccinated persons have a greatly reduced risk of
SARS-CoV-2 infection compared to unvaccinated individuals. This
includes severe infections
requiring hospitalization and those resulting in death, as well as less
severe symptomatic infections.
As stated above, the three authorized vaccine were shown to be
highly efficacious in clinical trials. Clinical trial results are
commonly considered a best case scenario (e.g., conducted in relatively
young and healthy populations), while evidence from follow-up
observational studies provides insight on a more diverse population.
This essential data from observational studies in populations who were
vaccinated outside of clinical trials is emerging and shows that the
mRNA vaccines are highly effective. At this time, observational studies
for the single dose, viral vector vaccine are not available. Some of
the studies for mRNA vaccines examined high-risk populations, such as
healthcare workers. Thus, the degree of protection in these studies can
be extrapolated to a wide range of workplace settings in healthcare.
The results from these studies are very encouraging.
A study of 3,950 health care personnel, first responders, and other
essential workers who completed weekly SARS-CoV-2 testing for 13
consecutive weeks reported 90% effectiveness (95% confidence interval
[CI] = 68%-97%) after full vaccination with either mRNA vaccine
(Thompson et al., April 2, 2021). Still, 22.9% of PCR-confirmed
infections required medical care; these included two hospitalizations
but no deaths. A study of more than 8,000 individuals in the U.S.
general population found that two doses of either mRNA vaccine were
88.7% effective in preventing SARS-CoV-2 infection (Pawlowski et al.,
February 27, 2021). Similar to the above results in essential workers,
although breakthrough infection occurred, vaccinated patients in this
study who were subsequently diagnosed with COVID-19 had significantly
lower 14-day hospital admission rates than matched unvaccinated
participants (3.7% vs. 9.2%). Hall et al., (April 23, 2021), in a study
of U.K. healthcare workers with bi-weekly testing, documented an 85%
effectiveness of the Pfizer-BioNTech vaccine, though those authors
required only one week after dose two for classification as fully
vaccinated. Research from Israel provides additional evidence of high
effectiveness for the Pfizer-BioNTech vaccine (Dagan et al., February
24, 2021).
Data available regarding vaccine efficacy against some SARS-CoV-2
variants of concern illustrate that the vaccines remain effective at
reducing symptomatic infections. Two doses of the Pfizer-BioNTech
COVID-19 vaccine was highly effective (85-86%) against SARS-CoV-2
infection and symptomatic COVID-19 during a period when B.1.1.7 was the
predominant circulating strain in the UK (Hall et al., April 23, 2021).
In Israel, the Pfizer-BioNTech vaccine was 92% effective even with the
proportion of cases due to the B.1.1.7 becoming the dominant virus in
circulation towards the end of the evaluation period (Dagan et al.,
February 24, 2021). Another study testing the Pfizer-BioNTech COVID-19
vaccine found that it was equally capable of neutralizing the notable
variants from the United Kingdom and South Africa (Xie et al., February
8, 2021). This finding was then reflected in a Qatari study that found
that the Pfizer-BioNTech vaccine was not only effective at preventing
disease in people infected by those variants, but was observed as 100%
effective in preventing fatalities from COVID-19 (Abu-Raddad et al.,
May 5, 2021). The Janssen vaccine clinical trial was conducted during a
time in which SARS-CoV-2 variants were circulating in South Africa
(B.1.351 variant) and Brazil (P.2 variant). At 28 or more days past
vaccination, efficacy against moderate to severe/critical disease was
72% in the United States; 68% in Brazil; 64% in South Africa (FDA,
February 26, 2021). Although some studies have reported antibodies to
be less effective against the B.1.351 variant, antibody activity in
serum from vaccinated persons was generally higher than activity from
serum of persons who recovered from COVID-19 (CDC, April 2, 2021).
A major question not fully addressed in the original clinical
trials is whether vaccinated individuals can become infected and shed
virus, even if they are asymptomatic. Thompson et al., (April 2, 2021),
reported that 11% of the PCR-confirmed breakthrough infections in their
essential worker population were asymptomatic, indicating a concern for
asymptomatic transmission. However, this concern is based on studies
indicating asymptomatic transmission among unvaccinated individuals and
it is not known if this phenomena occurs in infected vaccinated
individuals. In the Moderna clinical trial, reverse transcription
polymerase chain reaction (RT-PCR) testing was performed on
participants at their second vaccination visit; asymptomatic positives
in the vaccinated group were less than half those in the placebo group
(Baden et al., December 30, 2020, supplemental files Table s18). In a
Mayo clinic study, an 80% reduction in risk of positive pre-procedural
screening tests was observed in patients tested after their second
vaccine dose (Tande et al., March 10, 2021). A study of more than
140,000 healthcare workers and their almost 200,000 household members
reported a 30% reduction in risk of documented COVID-19 cases in the
household members after the healthcare provider was fully vaccinated
(Shah et al., March 21, 2021). In the Israeli general population, the
estimated vaccine effectiveness for the asymptomatic infection proxy
group (infection without documented symptoms, which could have included
undocumented mild symptoms) was 90% at 7 or more days after the second
dose (Dagan et al., February 24, 2021). Preliminary data from Israel
suggest that people vaccinated with the Pfizer-BioNTech COVID-19
vaccine who develop COVID-19 have a four-fold lower viral load than
unvaccinated people (Levine-Tiefenbrun, February 8, 2021). As noted by
CDC (April 2, 2021), this observation may indicate reduced
transmissibility, because viral load is thought to be a major factor in
transmission (Marks et al., February 2, 2021).
The CDC has acknowledged that a ``growing body of evidence suggests
that fully vaccinated people are less likely to have asymptomatic
infection or transmit SARS-CoV-2 to others'' (CDC, April 2, 2021). The
decreased risk for infection, especially serious infection, combined
with decreased risk of transmission to others has allowed the CDC to
relax some recommendations for individuals who are in community or
public settings and who are fully vaccinated with one of the three FDA
authorized vaccines, as follows.
Quarantine is no longer required for fully vaccinated
individuals who remain asymptomatic following exposure to a COVID-19
infected person (CDC, May 13, 2021).
Testing following a known exposure is no longer needed for
a fully vaccinated person, as long as the individual remains
asymptomatic and is not in specific settings such as healthcare (CDC,
April 27, 2021a), non-healthcare congregate facilities (e.g.,
correctional and detention facilities, homeless shelters) or high-
density workplaces (e.g., poultry processing plants) (CDC, May 13,
2021).
In non-healthcare settings, fully vaccinated people no longer need
to wear a mask or physically distance, except where required by
federal, state, local, tribal, or territorial laws, rules, and
regulations, including local business and workplace guidance (CDC, May
13, 2021). In healthcare settings, the picture is more mixed. While the
CDC still recommends source controls for vaccinated healthcare workers
to protect unvaccinated people, it has relaxed several NPIs for health
care providers (HCP) in some circumstances. CDC has stated that ``fully
vaccinated HCP could dine and socialize together in break rooms and
conduct in-person meetings without source control or physical
distancing'' (CDC, April 27, 2021a). The CDC also recommends that fully
vaccinated HCP no longer need to be restricted from work after a high-
risk exposure, as long as they remain symptom-free (CDC, April 27,
2021a). Perhaps more significantly, while acknowledging the growing
body of evidence against SARS-CoV-2 transmission from vaccinated people
to unvaccinated people, the CDC has not identified evidence of a
substantial risk of such transmission even in healthcare settings.
Therefore, pending additional evidence of such transmission, the risk
of transmission from vaccinated healthcare workers to unvaccinated co-
workers does not appear to be high enough to warrant OSHA's imposition
of mandatory controls through an ETS to protect unvaccinated workers
from exposure to vaccinated workers.
On the other hand, HCP treating suspected and confirmed COVID-19
patients are expected to have higher exposures to the SARS-CoV-2 virus
than others in the workforce, because such work involves repeated
instances of close contact with infected patients (Howard, May 22,
2021). Exposure can be even higher in aerosol generating activities.
Indeed, one study reported higher infection rates among vaccinated HCWs
during a regional COVID-19 surge (Keehner et al., Mar. 23, 2021). Thus,
the CDC has not relaxed infection control practices or PPE intended to
protect HCP, including respirator use. (CDC, April 27, 2021a). NIOSH
has stated that the ``available evidence shows that healthcare workers
are continuing to become infected with SARS-CoV-2 . . . including both
vaccinated and unvaccinated workers, and the conditions for the
transmission of the virus exist at healthcare workplaces'' (Howard, May
22, 2021). The CDC has also indicated that it will continue ``to
evaluate the impact of vaccination; the duration of protection,
including in older adults; and the emergence of novel SARS-CoV-2
variants on healthcare infection prevention and control
recommendations'' (CDC, April 27, 2021a). OSHA, too, will continue to
monitor this issue and revise the ETS as appropriate.
Grave Danger Exists in Healthcare Workplaces Where Unvaccinated Workers
Are Present
The evidence shows that the advent of vaccines does not eliminate
the grave danger from exposure to SARS-CoV-2 in healthcare workplaces
where less than 100% of the workforce is fully vaccinated. Unvaccinated
workers can transmit the virus to each other and can become infected as
a result of exposure to persons with COVID-19 who enter the healthcare
facility. An outbreak of COVID-19 due to an unvaccinated, symptomatic
HCP was recently reported in a skilled nursing facility in which 90.4%
of residents had been vaccinated (Cavanaugh, April 30, 2021). The
outbreak, due to the R.1 variant, caused attack rates that were three
to four times higher in unvaccinated residents and HCPs as among those
who were vaccinated. Additionally, unvaccinated persons were
significantly more likely to experience symptoms or require
hospitalization. Therefore, unvaccinated employees at these workplaces
remain at grave danger of infection, along with the serious health
consequences of COVID-19, as discussed in the remainder of this
section.
Although the risk appears to be lower, breakthrough infections of
vaccinated individuals do occur, but the potential for secondary
transmission remains not fully substantiated. For instance, a small yet
significant portion of the population does not respond well to
vaccinations (Agha et al., April 7, 2021; Boyarsky et al., May 5, 2021;
Deepak et al., April 9, 2021; ACI, April 28, 2021) and may be as
vulnerable as unvaccinated individuals. These individuals could
potentially transmit the SARS-CoV-2 infection to unvaccinated
employees. In a California study, seven out of 4,167 fully vaccinated
health care workers experienced breakthrough infections (Keehner et
al., May 6, 2021). A similar study from the Mayo Clinic, included
44,011 fully vaccinated individuals with 30 breakthrough infections
being recorded (Swift et al., April 26, 2021). Of those breakthrough
cases, 73% were symptomatic. Secondary transmission was not evaluated
in the study. A nursing facility in Chicago found 22 possible
breakthrough cases of SARS-COV-2 infection among fully vaccinated staff
and residents (Teran et al., April 30, 2021). Of those cases, 36% were
symptomatic. However, no secondary transmission was observed in the
facility. The lack of secondary transmission was likely due to the
facility's implementation of non-pharmaceutical interventions and high
vaccination rates. The authors concluded that to ensure outbreaks do
not occur from breakthrough infections in workplaces with vaccinated
and unvaccinated workers that the facilities need to maintain high
vaccine coverage and non-pharmaceutical interventions. While these
breakthrough events appear to be uncommon, it is important to remember
how quickly a few cases can result in an outbreak in unvaccinated
populations.
Moreover, even though the U.S. is approaching the time where there
is sufficient vaccine supply for the entire U.S. population,
administering the vaccine throughout the country will still take more
time. As of May 24, 2021, CDC statistics show that 43% of the
population between 18 and 65 has been fully vaccinated (CDC, May 24,
2021a). To this end, there is still a need to strengthen confidence in
the safety and effectiveness of the vaccines for significant portions
of the population, including workers, to reduce vaccine hesitancy. Even
in the healthcare industry, where distribution has enabled entire
worker populations to be completely vaccinated by now, some workers
exhibited reluctance to getting vaccinated. On January 4, 2021, a study
of 1,398 U.S. emergency department health care personnel found that 95%
were offered the vaccine, with 14% declining (Schrading et al.,
February 19, 2021). In February of 2021, the CDC released a study of
initial vaccine efforts at skilled nursing facilities offering long-
term care (Gharpure et al., February 5, 2021). The study found that
only 37.5% of eligible staff were vaccinated, leaving a potentially
significant population vulnerable to SARS-CoV-2 infections and capable
of transmission.
An anonymous survey of employees across the Yale Medicine and Yale
New Haven Health system was used to estimate the prevalence of and
underlying reasons for COVID-19 vaccine hesitancy. The survey was sent
to about 33,000 employees and medical staff across the Yale healthcare
system and included clinical staff and those who support the critical
infrastructure without direct patient contact (e.g., food service
staff). Out of 3,523 responses (an 11% response rate), 85% of
respondents stated they were ``extremely likely'' or ``somewhat
likely'' to receive the COVID-19 vaccine. Of that 85%, 12% expressed
mild hesitancy by stating they would get it within the next 6 months.
But 14.7% of overall respondents expressed reluctance by responding
``neither likely nor unlikely,'' ``somewhat unlikely,'' or ``extremely
unlikely'' to receive the COVID-19 vaccine. Overall, 1 in 6 personnel
in this health system survey expressed at least
some reluctance to get vaccinated (Roy et al., December 29, 2020).
Findings in more recent surveys of the general working population
from 18 to 65 years old show similar rates of people who stated they
would not, probably would not, or would only if required get vaccinated
(18.2%) (Census Bureau, May 5, 2021); 17-26% (KFF, April 22, 2021). In
March 2021, a survey found that healthcare employees reported some of
the highest vaccination percentages of any sector (78.3% and 67.7%,
respectively; King et al., April 24, 2021). However, future growth of
vaccination may be a concern with vaccine hesitation in those sectors
reported as 14.1% and 15.9%, respectively.
That unvaccinated healthcare workers remain in grave danger is
emphasized by the fact that thousands of new hospital admissions still
occur each day (CDC, May 24, 2021b) in the midst of significant
distribution of over three hundred million effective vaccine doses.
These factors indicate that transmission remains robust and significant
portions of the population remain vulnerable to COVID-19. Spread of the
disease within the healthcare workforce may start with a worker
becoming ill through community transmission or an ill patient seeking
treatment. The rate of new cases, hospitalizations, and deaths peaked
in January 2021, just before vaccines became more widely available
outside of healthcare settings. The January to February decline,
however, is likely not attributable in large part to the new vaccines
alone, because only a small portion of the population had received
them. During this time, variants of concern, such as B.1.1.7, that are
more transmissible and may result in worse health outcomes, have become
the majority source of infection (CDC, May 24, 2021c). Hundreds of
people each day are still dying of COVID-19 in early May 2021, many of
them working-age adults (May 24, 2021d).
OSHA will continue to monitor trends as more of the population
becomes vaccinated and the post-vaccine evidence base continues to
grow. If and when OSHA finds a grave danger from the virus no longer
exists for covered healthcare workplaces (or some portion thereof), or
new information necessitates a change in measures necessary to address
the grave danger, OSHA will update the rule as appropriate.
In summary, the availability and use of safe and effective vaccines
for COVID-19 is a critical milestone that has led to a marked decrease
in risk for healthcare employees generally, but grave danger still
remains for those whose jobs require them to work in settings where
patients with suspected or confirmed COVID-19 receive care. CDC has
determined that the remaining risk for fully vaccinated persons outside
of healthcare settings is low enough to justify foregoing other layers
of controls for settings where all persons are fully vaccinated and
asymptomatic (CDC, April 27, 2021), but the CDC continues to recommend
respirators and PPE for fully vaccinated healthcare employees in
settings where patients with suspected or confirmed COVID-19 receive
care. Based on CDC guidance and the best available evidence, OSHA finds
a grave danger in healthcare for vaccinated and unvaccinated HCP
involved in the treatment of COVID-19 patients.
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King, WC et al., (2021, April 24). COVID-19 vaccine hesitancy
January-March 2021 among 18-64 year old US adults by employment and
occupation. medRxiv; https://www.medrxiv.org/content/10.1101/2021.04.20.21255821v3. (King et al., April 24, 2021).
Levine-Tiefenbrun, M et al., (2021, February 8). Decreased SARS-CoV-2 viral load following vaccination. medRxiv. 2021; https://www.medrxiv.org/content/10.1101/2021.02.06.21251283v1.full.pdf.
(Levine-Tiefenbrun, February 8, 2021).
Marks, M et al., (2021, February 2). Transmission of COVID-19 in 282
clusters in Catalonia, Spain: A cohort study. Lancet Infect Dis.
21(5): 629-636. doi: 10.1016/S1473-3099(20)30985-3. Epub 2021 Feb 2.
PMID: 33545090; PMCID: PMC7906723. (Marks et al., February 2, 2021).
Pawlowski, C et al., (2021, February 27). FDA-authorized COVID-19
vaccines are effective per real-world evidence synthesized across a
multi-state health system. medRxiv [Preprint posted online February
27, 2021]. https://www.medrxiv.org/content/10.1101/2021.02.15.21251623v3. (Pawlowski et al., February 27, 2021).
Roy, B et al., (2020, December 29). Health care workers' reluctance
to take the COVID-19 vaccine: A consumer-marketing approach to
identifying and overcoming hesitancy. https://catalyst.nejm.org/doi/full/10.1056/CAT.20.0676. (Roy et al., December 29, 2020).
Schrading, WA et al., (2021, February 19). Vaccination rates and
acceptance of SARS-CoV-2 vaccination among U.S. emergency department
health care personnel. Acad Emerg Med 28: 455-458. (Schrading et
al., February 19, 2021).
Shah, ASV et al., (2021, March 21). Effect of vaccination on
transmission of COVID-19: an observational study in healthcare
workers and their households. medRxiv. 2021 https://www.medrxiv.org/content/10.1101/2021.03.11.21253275v1. (Shah et al., March 21,
2021).
Swift, MD et al., (2021, April 26). Effectiveness of mRNA COVID-19
vaccines against SARS-CoV-2 infection in a cohort of healthcare
personnel. Clinical Infectious Diseases DOI: https://doi.org/10.1093/cid/ciab361. (Swift et al., April 26, 2021).
Tande, AJ et al., (2021, March 10). Impact of the COVID-19 Vaccine
on asymptomatic infection among patients undergoing pre-procedural
COVID-19 molecular screening. Clin Infect Dis. 2021 Mar 10: ciab229.
doi: 10.1093/cid/ciab229. Epub ahead of print. PMID: 33704435;
PMCID: PMC7989519. (Tande et al., March 10, 2021).
Teran, RA et al., (2021, April 30). Postvaccination SARS-CoV-2
infections among skilled nursing facility residents and staff
members--Chicago, Illinois, December 2020-March 2021. MMWR 70(17):
632-638. (Teran et al., April 30, 2021).
Thompson, MG et al., (2021, April 2). Interim estimates of vaccine
effectiveness of BNT162b2 and mRNA-1273 COVID-19 vaccines in
preventing SARS-CoV-2 infection among health care personnel, first
responders, and other essential and frontline workers--eight U.S.
locations, December 2020-March 2021. MMWR 70: 495-500. DOI: http://dx.doi.org/10.15585/mmwr.mm7013e3. (Thompson et al., April 2, 2021).
Xie, X et al., (2021, February 8). Neutralization of SARS-CoV-2
spike 69/70 deletion, E484K and N501Y variants by BNT162b2 vaccine
elicited sera. Nature Medicine. DOI: https://doi.org/10.1038/s41591-021-01270-4. (Xie et al., February 8, 2021).
III. Impact on Healthcare Employees
Data on SARS-CoV-2 infections, illnesses, and deaths among
healthcare employees supports OSHA's finding that COVID-19 poses a
grave danger to these employees. Even fairly brief exposure (i.e., 15
minutes during a 24-hour period) can lead to infection, which in turn
can cause death or serious impairment of health. Employees in
healthcare settings include healthcare employees, who provide direct
patient care (e.g., nurses, doctors, and emergency medical technicians
(EMTs)), and healthcare support employees, who provide services that
support the healthcare industry and may have contact with patients
(e.g., janitorial/housekeeping, laundry, and food service employees).
Employees who perform autopsies are also considered to work in
healthcare. Most employees who work in healthcare perform duties that
put them at elevated risk of exposure to SARS-CoV-2.
SARS-CoV-2 is introduced into healthcare settings by infected
patients, other members of the public, or employees. Workers in
healthcare settings that provide treatment to patients with suspected
or confirmed COVID-19 face a particularly elevated risk of contracting
SARS-CoV-2 (Howard, May 22, 2021). Once the virus is introduced into
the worksite, the virus can be transmitted from person-to-person at
close contact through inhalation of respiratory droplets. In limited
scenarios, it might also be transmitted through inhalation of aerosols,
which consists of small droplets and particles that can linger in the
air, especially in enclosed spaces with inadequate ventilation (CDC,
May 7, 2021). Less frequently, transmission is also possible when
someone touches a contaminated item or surface and then touches their
nose, mouth, or eyes (CDC, April 5, 2021).
A 2021 cross-sectional study of 6,510 healthcare employees from the
Northwestern HCW SARS-CoV-2 Serology Cohort Study (conducted May 28-
June 30, 2020 in Illinois) shows that infections among healthcare
workers were not limited to doctors and nurses; healthcare
administrators had similar rates of seropositivity compared to
physicians, and support services had the highest seroprevalence (this
group included healthcare facility workers in
food service, environmental services, security, and patient access/
registration) (Wilkins et al., 2021). A meta-analysis published in the
American Journal of Epidemiologists compared data from 97 separate
studies and found evidence that COVID-19 infections were both common
(11% of the tested cohort of healthcare employees) and spread among
different healthcare worker occupations. In this study, however, nurses
had the highest rate of seroprevalence while most of the COVID-19-
positive medical personnel were working in hospital nonemergency wards
during screening (Gomez-Ochoa et al., January 2021).
Healthcare employees who provide direct patient care are at high
risk of exposure to SARS-CoV-2 because they have close and sometimes
prolonged contact with patients who are infected or potentially
infected with SARS-CoV-2. This contact occurs when conducting physical
examinations and providing treatment and medical support. The risk can
be amplified when examining or treating a COVID-19 patient who has
symptoms such as coughing and difficulty breathing (leading to more
forceful inhalation and exhalation), both of which can result in the
release of more droplets that can be propelled further. Healthcare
employees who conduct, or provide support during, aerosol-generating
procedures on persons with suspected or confirmed COVID-19 also face a
greater risk of infection (Heinzerling et al., April 17, 2020).
Examples of procedures that can produce aerosols include intubation,
suctioning airways, use of high-speed tools during dental work, and use
of power saws during autopsies. A complete list of aerosol-generating
procedures, as defined by this ETS, is included in 29 CFR 1910.502(b).
Employees in healthcare are also at risk of exposure to SARS-CoV-2 if
they have close contact with co-workers while providing patient care or
performing other duties in enclosed areas such as a nursing station,
laundry room, or kitchen. Based on the biological mechanisms of SARS-
CoV-2 transmission, there is no doubt that some employees in healthcare
are at risk of exposure to SARS-CoV-2. Healthcare employees are
performing some job tasks that create an expectation of exposure to
people or human remains infected with COVID-19. The nature of caring
for a patient known to have COVID-19 or performing on autopsy on
someone who had COVID-19 increases the risk to employees performing
that task.
This section summarizes recent studies about U.S. employees in
healthcare that illustrate the impact of COVID-19 in several types of
settings. Because the pandemic is recent and the evidence generated is
on the frontiers of science, studies are not available for every type
of employee in every type of healthcare setting. The peer-reviewed
scientific journal articles, government reports, and journal pre-print
articles described below establish the widespread prevalence of COVID-
19 among healthcare employees. OSHA's findings are based primarily on
the evidence from peer-reviewed scientific journal articles and
government reports. However, peer review for scientific journal
articles and the assembly of information for government reports and
other official sources of information take time, and therefore those
sources do not always reflect the most up-to-date information (Chan et
al, December 14, 2010). This is critical in the context of the COVID-19
pandemic, where new information is emerging daily. Therefore, OSHA has
supplemented peer-reviewed data and government reports with additional
information on occupational outbreaks contained in other sources of
media (e.g., newspapers). The reported information from newspapers can
provide further evidence of the impact of an emerging and changing
disease, especially for certain workers in healthcare and associated
occupations (e.g., laundry workers, janitors) that are not well
represented in the peer-reviewed scientific literature, and assist OSHA
in protecting these employees from the grave danger posed by
transmission of SARS-CoV-2. OSHA did not make findings based solely on
non-peer-reviewed sources such as pre-prints and news articles, but the
agency found that those sources sometimes provided useful information
when considered in context with more robust sources. Together, these
sources of information represent the best available evidence of the
impact on employees of the pandemic thus far.
The peer-reviewed literature, government reports and, in a limited
number of cases, non-peer-reviewed articles illustrate a significant
number of infections among healthcare employees, but the types of
workplaces or conditions described are not the only ones in which a
grave danger exists. However, the studies add to the evidence that any
healthcare employee is at risk of exposure if they have close contact
with others who are suspected or confirmed to have COVID-19. The
studies also provide evidence that once SARS-CoV-2 is introduced into
the healthcare workplace (e.g., through an infected patient, other
member of the public, or employee), unvaccinated employees in that
workplace are at risk of exposure.
a. General Investigations of Workers or Workplaces
The Washington State Department of Health and the Washington State
Department of Labor and Industries collaborated on a report evaluating
COVID-19 cases and their occupational history (WSDH and WLNI, November
10, 2020). They identified 30,895 confirmed cases of COVID-19 in
Washington State with occupational data, including healthcare settings,
through September 13, 2020. They reported infection rates for 22
occupational groups, and reported that healthcare and social assistance
were among the industry sectors with the highest incidence of
infections (WSDH and WLNI, November 10, 2020). The report states that
some occupations increase the risk to workers of exposure to SARS-CoV-
2, but the data does not demonstrate that all the cases reported
resulted from occupational exposure.
These data were also used to determine how work activities were
related to COVID-19. Zhang used information from a previous Washington
State report with an earlier cutoff date (through June 11, 2020; 10,850
cases) and cross-referenced it with information available from O*NET (a
Department of Labor database that contains detailed occupational
information for more than 900 occupations across the U.S.) to determine
occupation-specific COVID-19 risks (Zhang, November 18, 2020). Zhang
created a model using the O*NET descriptors and correlated it to the
case reports from Washington State to develop a predictive model for
COVID-19 cases. The model found that among O*NET's 57 physical and
social factors related to work, the two predictive variables of COVID-
19 risk were frequency of exposure to diseases and physical proximity
to other people. The author found that healthcare professions in
general had the highest predicted risk for COVID-19. This finding
provides additional evidence that during an active pandemic, healthcare
employees can be exposed to a grave danger during sustained periods in
workspaces where they are working in proximity to others, including
patients with COVID-19.
The Oregon Health Authority (OHA) publishes a weekly report
detailing outbreaks directly related to work settings. OHA
epidemiologists consider cases to be part of a workplace outbreak when
clusters form with respect to space and time unless their
investigation uncovers an alternative source for the outbreak. In their
May 19, 2021, COVID-19 Weekly Report, OHA reported 71 active clusters,
including at three separate hospitals (OHA, May 19, 2021).
In a May 21, 2021 report, the Tennessee Department of Health
reported 238 active clusters (i.e., 2 or more confirmed cases of COVID-
19 linked by the same location of exposure or exposure event that is
not considered a household exposure), with 6 occurring in assisted care
facilities, 37 in nursing homes, and 3 in other healthcare settings
(Tennessee Department of Health, May 21, 2021).
A study on SARS-CoV-2 testing in Los Angeles from mid-September
through October 2020 evaluated 149,957 symptomatic and asymptomatic
positive cases associated with an occupation (Allan-Blitz et al.,
December 11, 2020). Infection rates were found to be particularly high
for healthcare personnel and first responders.
A Morbidity and Mortality Weekly Report (MMWRs) (a weekly
epidemiological digest published by the CDC) reported on the
occupational status of COVID-19 cases in Colorado. In the Colorado
study, 1,738 COVID-19 cases from nine Colorado counties were evaluated;
these cases occurred before the state lockdown that began on March 26,
2020 (Marshall et al., June 30, 2020). Half of the individuals were
exposed in a workplace setting, with the greatest number of COVID-19-
positive employees coming from healthcare (38%).
Chen et al., (January 22, 2021) analyzed records of deaths
occurring on or after January 1, 2016 in California and found that
mortality rates in working aged adults (18-65 years) increased 22%
during the COVID-19 pandemic (March through October 2020) compared to
pre-pandemic periods. Relative to pre-pandemic periods, healthcare or
emergency workers were one occupational group that experienced excess
and statistically significant mortality compared to pre-pandemic
periods (19% increase). The study authors concluded that essential work
conducted in person is a likely avenue of infection transmission.
Hawkins et al., (January 10, 2021) examined death certificates of
individuals who died in Massachusetts between March 1 and July 31,
2020. An age-adjusted mortality rate of 16.4 per 100,000 employees was
determined from 555 death certificates that had useable occupation
information. Employees in healthcare support, personal care services,
and social services had particularly high mortality rates. The study
authors noted that occupation groups expected to have frequent contact
with sick people, close contact with the public, and jobs that are not
practical to do from home had particularly elevated mortality rates.
The impact of COVID-19 across diverse healthcare sectors is not
limited to the United States. The European Centre for Disease
Prevention and Control investigated clusters in occupational settings
throughout Europe (ECDC, August 11, 2020). The Centre reviewed 1,376
occupational clusters from 16 European countries from March through
July of 2020. Indoor settings contributed to 95% of reported clusters.
Hospitals and long-term care facilities accounted for many of the
clusters.
References
Allan-Blitz, L et al., (2020, December 11). High frequency and
prevalence of community-based asymptomatic SARS-CoV-2 Infection.
medRxix. https://doi.org/10.1101/2020.12.09.20246249. (Allan-Blitz
et al., December 11, 2020).
Centers for Disease Control and Prevention (CDC). (2021, April 5).
Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for
Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html. (CDC,
April 5, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. (CDC,
May 7, 2021).
Chan, E et al., (2010, December 14). Global capacity for emerging
infectious disease detection. Proceedings of the National Academy of
Sciences of the United States of America, 107(50), 21701-21706.
https://doi.org/10.1073/pnas.1006219107. (Chan et al, December 14,
2010).
Chen, Y et al., (2021, January 22). Excess mortality associated with
the COVID-19 pandemic among Californians 18-65 years of age, by
occupational sector and occupation: March through October 2020.
MedRxiv. doi: 10.1101/2021.01.21.21250266. (Chen et al., January 22,
2021).
European Centre for Disease Prevention and Control (ECDC). (2020,
August 11). COVID-19 clusters and outbreaks in occupational settings
in the EU/EEA and the UK. (ECDC, August 11, 2020).
G[oacute]mez-Ochoa, SA et al., (2021, January). COVID-19 in health-
care workers: a living systematic review and meta-analysis of
prevalence, risk factors, clinical characteristics, and outcomes.
American journal of epidemiology. 2021 Jan; 190(1): 161-75. (Gomez-
Ochoa et al., January 2021).
Hawkins, D et al., (2020, December 21). COVID-19 deaths by
occupation, Massachusetts, March 1-July 31, 2020. American Journal
of Industrial Medicine 64(4): 238-244. DOI: 10.1002/ajim.23227.
(Hawkins et al., December 21, 2021).
Heinzerling, A et al., (2020, April 17). Transmission of COVID-19 to
Health Care Personnel During Exposures to a Hospitalized Patient--
Solano County, California, February 2020. MMWR Morb Mortal Wkly Rep
2020; 69: 472-476. DOI: http://dx.doi.org/10.15585/mmwr.mm6915e5.
(Heinzerling et al., April 17, 2020).
Howard, J. (2021, May 22). ``Response to request for an assessment
by the National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services, of the current hazards facing healthcare
workers from Coronavirus Disease-2019 (COVID-19).'' (Howard, May 22,
2021).
Marshall, K et al., (2020, June 30). Exposure before issuance of
stay-at-home orders among persons with laboratory-confirmed COVID-
19--Colorado, March 2020. MMWR: 69(26): 847-9. (Marshall et al.,
June 30, 2020).
Oregon Health Authority (OHA). (2021, May 19). COVID-19 weekly
outbreak report. https://www.oregon.gov/oha/covid19/Documents/DataReports/COVID-19-Weekly-Outbreak-Report-2021-1-13-FINAL.pdf.
(OHA, May 19, 2021).
Tennessee Department of Health. (2021, May 21). COVID-19 critical
indicators. (Tennessee Department of Health. May 21, 2021).
Washington State Department of Health (WSDH) and Washington State
Department of Labor and Industries (WLNI). (2020, November 10).
COVID-19 confirmed cases by industry sector. Publication Number 421-
002. https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/IndustrySectorReport.pdf. (WSDH and WLNI, November 10, 2020).
Wilkins, JT et al., (2021). Seroprevalence and correlates of SARS-
CoV-2 antibodies in health care workers in Chicago. Open Forum
Infectious Diseases. 8(1): ofaa582. https://doi.org/10.1093/ofid/ofaa582. (Wilkins et al., 2021).
Zhang, M. (2020, November 18). Estimation of differential
occupational risk of COVID-19 by comparing risk factors with case
data by occupational group. American Journal of Industrial Medicine
64(1):39-47. doi: 10.1002/ajim.23199. (Zhang, November 18, 2020).
b. Studies Focusing on Employees in Healthcare
General Surveillance and Surveys Across the U.S.
Burrer et al., (2020) reported surveillance data on COVID-19 cases
and deaths among ``healthcare personnel'' between February 12 and April
9, 2020. ``Healthcare personnel'' were defined as ``paid and unpaid
persons serving in healthcare settings who have the potential for
direct or indirect exposure to patients or
infectious materials.'' \9\ Although only 16% of all surveillance forms
indicated whether the case was healthcare personnel, 19% of the
reported cases occurred in healthcare personnel. Twelve states
indicated whether the case was healthcare personnel for at least 80% of
all reported cases. An estimated 11% of COVID-19 cases from those 12
states were healthcare personnel. Based on reported known contact with
confirmed COVID-19 cases in the 14 days before illness onset, work
exposures likely caused 55% of those infections. Between 8% and 10% of
infected employees were hospitalized, 2%-5% of the infected employees
were admitted to the ICU, and 0.3%-0.6% of those employees died.
---------------------------------------------------------------------------
\9\ The term ``healthcare personnel'' is consistent with OSHA's
use of the terms ``healthcare employees'' and ``healthcare workers''
to include healthcare support workers.
---------------------------------------------------------------------------
CDC continues to provide general updates for COVID-19 cases and
deaths among healthcare personnel. However, information on healthcare
personnel status was reported for only 18.21% of total cases and death
status reported for only 79.57% of healthcare personnel cases as of May
24, 2021 (CDC, May 24, 2021a). CDC reports 491,816 healthcare personnel
cases (10% of the 4,856,885 cases that included information on
healthcare personnel status) and 1,611 fatalities (0.4% of healthcare
employee cases) as of May 24, 2021 (CDC, May 24, 2021a). Independent
reporting by Kaiser Health News and the Guardian in their ongoing
investigative reporting database found 3,607 fatalities among
healthcare personnel in the United States as of April 2021(Kaiser
Health News and the Guardian, April 2021; February 23, 2021). The
reporters for this effort consider even their own count--which is
higher than the official CDC count--to be an undercount due to various
reporting issues, such as a lack of reporting requirements for long-
term care employees for a significant portion of the initial COVID-19
surge.
Hartmann et al., (2020) analyzed case interview data from February
through May 2020 to assess the burden of COVID-19 on healthcare
employees in Los Angeles County, CA, where it is mandated that all
positive cases be reported to the County Department of Public Health,
and all cases are interviewed. Healthcare employees were defined as any
person working or volunteering in healthcare settings including
hospitals and skilled nursing facilities, medical offices, mental
health facilities, and emergency medical services (EMS). The definition
also includes healthcare employees providing care in non-healthcare
settings such as schools, senior living facilities, and correctional
facilities. Healthcare employees included both staff who interacted
directly with patients and staff who do not provide direct clinical
care to patients. Through May 31, 2020, 5,458 COVID-19 cases among
healthcare employees were reported to the County Health Department,
representing 9.6% of all cases during this time period. Of those
healthcare employees, 46.6% worked in a long-term care setting, 27.7%
worked in a hospital, and 6.9% worked in medical offices. Healthcare
employees from all other settings represented less than 4% of total
healthcare employee cases. Nurses represented 49.4% of all healthcare
employee cases; no other group of healthcare employees represented more
than 6% of the total reported healthcare employee cases. Of note is
that some healthcare associated employees who are expected to have less
close contact with patients represented a greater percentage of cases
than some healthcare employee that are expected to have close and
direct patient contact. For example, employees in administration
(4.3%), environmental services (3.2%), and food services (2.9%)
represented a higher percentage of infected healthcare employees than
physicians (2.7%). When asked about known exposures, 44% of those who
tested positive reported exposure to a COVID-19-positive patient or co-
worker in their health facility, 11% reported exposure to a COVID-19-
positive friend or family member or recent travel, and 45.1% had
unknown exposures. At the time of the interviews, 5.3% of COVID-19-
positive healthcare employees in Los Angeles County reported requiring
hospitalization because of COVID-19, and as of May 31, 2020 there were
40 (0.7%) deaths.
Fell et al., (October 30, 2020) reviewed exposure and infection
data for healthcare personnel in Minnesota between March and July of
2020. After the first confirmed case of COVID-19 in Minnesota (on March
6, 2020), the Minnesota Department of Health (MDH) requested that
healthcare facilities provide a list of exposed healthcare personnel.
Healthcare personnel included EMS personnel, nurses/nursing assistants,
physicians, technicians, therapists, phlebotomists, pharmacists,
students and trainees, contractors, and those who do not provide direct
patient care but could be exposed to infectious agents in a healthcare
setting (e.g., clerical, food services, environmental services,
laundry, security, engineering and facilities management,
administrative, billing, and volunteer personnel). Cases in laboratory
personnel are also reported. The facilities were asked to determine if
each exposure was high-risk, defined as when the healthcare personnel
has close, prolonged contact with a confirmed COVID-19 case or their
secretions/excretions while not wearing PPE, or close, prolonged
contact with persons with COVID-19 in their household or community. MDH
and the 1,217 participating healthcare facilities assessed 17,200
healthcare personnel for 21,406 exposures to COVID-19 cases, of which
5,374 (25%) were classified as higher-risk. It was reported that 373 of
5,374 personnel (6.9%) with high-risk exposures tested positive for
COVID-19 within 14 days of the exposure. The report stated that only
symptomatic personnel were encouraged to get tested for COVID-19, and
therefore it is possible that asymptomatic cases occurred and were not
detected. Of those 373 personnel who tested positive for COVID-19, 242
were exposed to a patient, resident of a congregate setting, in a
congregate setting outbreak, or to another healthcare personnel.
Twenty-one percent of exposures to a confirmed COVID-19 case took place
in acute or ambulatory care settings, 24% of exposures were to
residents in congregate living or long-term care settings, and 25% of
exposures were in congregate setting outbreaks. An additional 25% of
exposures to confirmed COVID-19 cases were exposures to co-workers, and
5% were exposures to household/social contacts.
The Fell study (October 30, 2020) also demonstrated that high risk
exposures can occur to healthcare employees in positions throughout the
healthcare facility. Available data for 4,669 (87%) of the higher risk
exposures in the Fell et al., study indicated that the highest
percentages of high-risk exposures were in nursing assistants or
patient care aides (1,857; 40%) and nursing staff (1,416; 30%). The
proportion of high-risk exposures represented by personnel such as
administrators (247; 5%) and environmental services staff (155; 3%)
were similar to those reported by medical providers, such as physicians
or nurse practitioners (220; 5%). Healthcare personnel working in
congregate living or long-term care settings, including skilled
nursing, assisted living, and group home facilities, were more likely
to receive a positive COVID-19 test result within 14 days of a higher-
risk exposure than were healthcare personnel working in acute care
settings. The study authors note the
potential for employee transmission by cautioning that, in contrast to
the recognized risk associated with patient care, healthcare employees
might have failed to recognize the risk associated with interacting
with co-workers in areas such as breakrooms and nursing stations.
Physical distancing and PPE may therefore not have been used as
consistently in those situations.
The authors of a different study concluded that nurses and EMTs
were, respectively, 26% and 33% more likely to contract COVID-19 than
attending physicians. Nurses and EMTs' job duties require more intense,
close contact with patients compared to physicians, as well as higher
frequency and duration of patient contact. Firew et al., (October 21,
2020) conducted a cross-sectional survey of healthcare employees in May
of 2020 across 48 states, the District of Columbia, and U.S.
territories. The 2,040 respondents who completed at least 80% of the
survey were included in the study. Among included participants, 31.1%
were attending physicians, 26.8% were nurses, 13% were EMTs, 8.82% were
resident physicians or fellows, 3.97% were physician assistants, and
16.32% were other healthcare employees. A total of 598 respondents
(29.3%) reported SARS-CoV-2 infections.
In a prospective study of over 2 million community members and
99,795 frontline healthcare workers that was performed in the U.S. and
UK from March through April 2020, healthcare workers were 3.4 times as
likely to self-report a positive COVID-19 test as the general public,
after adjusting for the increased likelihood of healthcare personnel
receiving a COVID-19 test (Nguyen et al., 2020). In the U.S. alone,
healthcare workers were almost two times more likely to report a
positive test after adjusting for greater likelihood of testing.
Detection of SARS-CoV-2 in Healthcare Employees
OSHA reviewed a number of studies that included hospital employees.
Many hospitals provide short-term and/or long-term care for COVID-19
patients who have symptoms that are severe enough to require
hospitalization. Therefore, close contact with COVID-19 patients is
expected in hospital settings, putting hospital employees at risk of
developing COVID-19. Examples of employees who work in hospitals
include healthcare practitioners, who generally have either licensure
or credentialing requirements (e.g., doctors, nurses, pharmacists,
physical therapists, massage therapists) for the purpose of promoting,
maintaining, monitoring, or restoring health. Individuals who provide
healthcare support services also work at hospitals. Examples of
employees who provide healthcare support services and may have close
contact with COVID-19 patients in some circumstances include patient
intake/admission, patient food services, chaplain services, equipment
and facility maintenance, housekeeping services, healthcare laundry
services, and medical waste handling services. As noted above, hospital
employees are at risk from close contact with patients.
Some of the studies reviewed below were done in employees of
healthcare systems that included both hospitals and ambulatory care
centers such as physician offices, medical clinics (including urgent
care and retail-based clinics), outpatient surgical centers, and
outpatient cancer treatment centers. Although this ETS does not cover
non-hospital ambulatory care settings where all non-employees are
screened prior to entry and people with suspected or confirmed COVID-19
are not permitted to enter, it was not possible to separate out results
for hospital versus ambulatory care employees. Also it is not known to
what extent those ambulatory care centers in the studies reviewed by
OSHA performed screening to identify suspected or confirmed COVID-19.
Risk of exposure and transmission of SARS-CoV-2 is expected to be lower
in ambulatory healthcare settings that perform screening to exclude
persons with suspected or confirmed COVID-19. However some types of
ambulatory medical facilities (e.g., family practice; pediatrics
clinic; urgent care) may choose to test patients for COVID-19 or
examine and treat COVID-19 patients on site. Therefore, healthcare
employees and healthcare support employees in some ambulatory care
centers who do not conduct health screening to identify and exclude
suspected or confirmed COVID-19 patients are at risk of infection due
to close contact with patients who could potentially have COVID-19.
Barrett et al., (2020) conducted a prospective cohort study of
healthcare employees and non-healthcare employees with no known
previous SARS-CoV-2 infection who were recruited and tested for SARS-
CoV-2 from March 24 through April 7, 2020 at Rutgers University and two
of its affiliated university hospitals in New Jersey. As of July 2020,
New Jersey was one of the hardest hit areas, with less than 3% of the
U.S. population but 8.5% of all known U.S. cases. Healthcare employees
were defined as individuals who worked at least 20 hours per week in a
hospital, had occupations with regular patient contact, and were
expected to have contact with at least three patients per shift over
the following three months. Occupations included residents, fellows,
attending physicians, dentists, nurse practitioners, physician
assistants, registered nurses, technicians, respiratory therapists, and
physical therapists. Non-healthcare employees included faculty, staff,
trainees, or students working at Rutgers for at least 20 hours a week
and who had no patient contact. The study reported that 7.3% of
healthcare employees (40 of 546) and 0.4% of non-healthcare employees
(1 of 283) tested positive for SARS-CoV-2 infection. Even after the
authors conducted sensitivity analyses to exclude individuals with
symptoms at baseline and those who had exposure to someone with COVID-
19 or COVID-19 symptoms outside of work, differences between infection
rates in healthcare employees and non-healthcare employees continued to
be observed. OSHA finds this suggests that healthcare employees were
more likely than non-healthcare employees to have developed COVID-19
from a workplace exposure during the early months of the pandemic in
the United States. The study authors concluded that the potential for
workplace exposure is further supported by the fact that only 8% of
infected study subjects reported contact with someone having COVID-19
symptoms outside of work. In addition, higher rates of infection were
observed in healthcare employees who worked in the hospital that had
more COVID-19 patients and was located in the community that had higher
rates of SARS-CoV-2 infections. The study authors noted that because
that hospital was overwhelmed, it was not always possible to separate
COVID-19 vs. non-COVID-19 patients, which may have led to additional
exposures among staff. Among healthcare employees, nurses had the
highest rate of observed infections (11.1% tested positive), and
attending physicians had the lowest rate of observed infection (1.8%
positive). Resident and fellow physicians had a 3.1% positivity rate
and other groups of healthcare employees had a 9% positivity rate.
Increased risk of infection was associated with spending greater
proportions of work time in patients' rooms and higher reported
exposures to patients with suspected or diagnosed COVID-19.
Mani et al., (November 15, 2020) reported results from SARS-CoV-2
testing of 3,477 symptomatic employees in the University of Washington
Medical system and its affiliated organizations in Seattle, WA, between
March 12 and April 23, 2020. During that period, 185 (5.3%) employees
tested positive. Prevalence (i.e., proportion) of SARS-CoV-2 in
frontline healthcare employees (those with face-to-face contact with
patients) was 5.2% and prevalence in non-frontline staff was 5.5%. Some
staff who were asymptomatic also underwent screening as part of
outbreak investigations, and 9 of 151 (6%) tested positive. When
findings from symptomatic and asymptomatic staff were combined, SARS-
CoV-2 prevalence was 5.3% in frontline healthcare employees and 5.3%
among all employees. Of the 174 employees who tested positive and were
followed, six (3.2%) reported COVID-related hospitalization, and one
employee was admitted to the ICU. No deaths were reported. The study
authors suspected that community transmission likely played a major
role in infection among healthcare employees early in the local
epidemic and that similar percentages of infections in frontline and
non-frontline healthcare employees support the PPE protocols
implemented for frontline workers at the institution. In addition,
positive cases were likely underestimated due to the focus on testing
symptomatic employees.
Vahidy et al., (2020) studied asymptomatic infection rates among
staff from a medical center consisting of seven hospitals in Texas and
members of the surrounding community in March through April of 2020.
Healthcare jobs with possible exposure to COVID-19 patients were
classified into five categories, with varying levels of patient
exposure: (1) Nursing (e.g., nurses/nurses aids, emergency medical
technicians), (2) clinicians (e.g., physicians, nurse practitioners),
(3) allied healthcare workers (e.g., therapists, social workers), (4)
support staff (e.g., security, housekeeping), and (5) administrative or
research staff (e.g., managers, research assistants). A total of 2,872
asymptomatic individuals, including 2,787 healthcare personnel and 85
community residents, were tested for SARS-CoV-2 infection. Among the
healthcare personnel tested, the prevalence of SARS-CoV-2 infection was
5.4% among the 1,992 patient-facing staff treating COVID-19 patients
and 0.6% among the 625 patient-facing staff not treating COVID-19
patients. No cases were seen among the 170 nonclinical healthcare staff
that did not interact with patients or in the 85 community residents
(Vahidy et al., 2020). The nonclinical healthcare staff worked in
buildings with separate heating, ventilation, and air conditioning
systems, and with lower population density because of remote work when
compared to clinical healthcare staff. In the different healthcare
categories that cared for COVID-19 patients, prevalence of infection
ranged from 3.6% to 6.5%, with no significant differences in the
different categories of healthcare workers. Therefore, the study
indicates that healthcare workers providing both direct and indirect
care to COVID-19 patients are at risk.
Nagler et al., (June 28, 2020), reported the results of SARS-CoV-2
testing in employees from the New York Langone Health system, an
academic medical center encompassing four hospital campuses and over
250 ambulatory sites, with approximately 43,000 employees. Between
March 25 and May 18, 2020, the health system tested employees who were
symptomatic (4,150), were asymptomatic but exposed to COVID-19 (4,362),
and asymptomatic employees who were returning to work after their
services had been suspended during the peak of the epidemic (6,234).
Among symptomatic employees, the COVID-19 positivity rate across the
duration of the study was 33%. Among asymptomatic employees with self-
reported exposure, the COVID-19 positivity rate was 8%. In asymptomatic
employees returning to work, COVID-19 positivity rate was 3%. In all
groups, the positivity rate in the first week of testing was
substantially higher than in the last week of testing, which occurred
more than a month after the first week. The study authors noted a
temporal correlation of COVID-19 case declines in healthcare employees
and the community, despite continued workplace exposure, and suggested
that infections in healthcare employees may reflect importance of
community transmission and efficacy of stringent infection control and
PPE standards that remained largely unchanged since the start of the
pandemic in March 2020. OSHA finds that the study demonstrates the
potential for COVID-19 to be introduced into the workplace from
uncontrolled community spread and that the effective use of infection
control practices and PPE most likely prevented transmission to
healthcare employees.
Misra-Hebert et al., (September 1, 2020) conducted a retrospective
cohort study to obtain data on rates of COVID-19 and risk factors for
severe disease in healthcare employees and non-healthcare employees
(neither category defined) who were tested for SARS-CoV-2, and listed
in a registry at the Cleveland Clinic Health System, between March 8
and June 9, 2020. The data was drawn from healthcare employees from
different segments of the country. Ninety percent of the healthcare
employees and 75% of non-healthcare employees were from Ohio, and the
remainder were from Florida. Although more healthcare employees than
non-healthcare employees reported exposures to COVID-19 (72% vs. 17%),
similar, and not significantly different, proportions of employees
tested positive for COVID-19 in each group: 9% (551/6145) of healthcare
employees and 6.5% (4353/66,764) of non-healthcare employees. OSHA
finds it difficult to draw conclusions regarding this finding because
the nature of the exposure (e.g., whether it was at close contact) was
not explained. In fact, patient-facing healthcare employees (those
having direct contact with patients) were 1.6 times more likely than
non-patient-facing healthcare employees to test positive. The study
authors suggested that the finding represents an increased risk of
infection with work exposure, however they were not able to confirm if
the exposure occurred 14 days prior to testing or if PPE was worn
during the exposure. Positive cases peaked in early-to-mid April for
both healthcare employees and non-healthcare employees (16% and 12%,
respectively, as estimated from figure 2 of the study), and then
decreased concurrently with the implementation of preventive measures,
such as masking and physical distancing, over the course of the study.
Of those who tested positive, 6.9% of healthcare employees and 27.7% of
non-healthcare employees were hospitalized, and 1.8% and 10.8%
respectively, were admitted to the intensive care unit. The study noted
that the lower rates of hospitalization for the healthcare employee
group could be explained on the basis that the healthcare employee
population was younger and had fewer co-morbidities.
Serology Testing in Employees in Hospitals.
Although most of the studies described in this section relied on
polymerase chain reaction (PCR) tests to detect cases of COVID-19, a
number of studies conducted serology testing to determine how many
individuals had been infected by the SARS-CoV-2 virus in the past.
Serology tests determine if antibodies that respond to the SARS-CoV-2
virus are present in samples of blood serum. Seroprevalence is the
percentage of individuals in a population who have antibodies. Terms
such as seropositive or seroconversion are often used to describe
persons who have tested positive for the SARS-CoV-2 antibody. Most of
the serology tests
conducted looked at a type of antibody known as Immunoglobulin G (IgG).
Seroprevalence studies provide a more complete picture of how many
individuals in a population may have been infected because many
individuals who were infected were not tested for current infections
for reasons such as lack of symptoms and lack of available testing.
Indeed, many individuals who were asymptomatic may be unaware that they
were exposed to SARS-CoV-2 or had COVID-19 (CDC, July 6, 2020). The
studies described below were conducted before vaccination began, and it
is therefore unlikely that the studies are detecting antibodies
produced as a result of vaccination.
Venugopal et al., (2020) conducted a cross-sectional study of
healthcare employees across all hospital services (including
physicians, nurses, ancillary services, and ``others'') who worked at a
level one trauma center in the South Bronx, NY between March 1 and May
1, 2020. The period of analysis included the first few weeks of March,
when New York City experienced a surge of infections that resulted in
strained resources and supplies such as PPE. This hospital was so
highly impacted that it was considered ``the epicenter of the
epicenter.'' Participants were tested for IgG antibodies. They were
also tested for SARS-CoV-2. Of the 500 out of 659 healthcare employees
who completed serology testing, 137 (27%) were positive for SARS-CoV-2
IgG antibodies. Seroprevalence was similar across the different types
of healthcare employees (25% to 28%). The study authors indicated that
seroprevalence in healthcare employees was higher than in the
community, and that seroprevalence likely reflected healthcare and
community exposures.
Sims et al., (November 5, 2020) conducted a prospective cohort
serology study at Beaumont Health, which includes eight hospitals
across the Detroit, MI metropolitan area. In April of 2020, during the
peak of the pandemic's first wave, Michigan had the third highest
number of cases in the U.S. and most cases were in the Detroit
metropolitan area. All 43,000 hospital employees were invited to
participate and seroprevalence was analyzed in 20,614 of them between
April 13 and May 28, 2020. A total of 1,818 (8.8%) of participants were
seropositive. However, when separated according to employees working at
home (n=1,868) versus working in their normal manner, employees working
at home were significantly less likely to be seropositive (5.6%) than
those going into work (9.1%). The authors speculated that the
seropositivity level for employees working at home was representative
of the population sheltering at home and only leaving home when
necessary. Participants involved with direct patient care had a higher
seropositive rate (9.5%) than those who were not (7%). Healthcare
employees with frequent patient contact (phlebotomy, respiratory
therapy, and nursing) had a significantly higher seropositive rate
(11%) than those with intermittent patient contact (physicians or
clinical roles such as physical therapists, radiology technicians,
etc.), who on average had a seropositive rate of 7.4%. The study
authors speculated that the differences in these two groups may have
been based on differences in both duration and proximity of exposure to
patients. Another notable observation is that support personnel such as
facilities/security and administrative support employees had
seropositivity rates of approximately 7% to 8%, which were similar to
rates in physicians (values estimated from Figure 2B). Participants
reporting frequent contact with either 1) non-COVID-19 patients, or 2)
physicians or nurses but not patients, had higher rates of
seropositivity (7.6%) than those reporting no significant contact with
patients, physicians, or nurses (but who handled patient samples)
(6.5%).
Moscola et al., (September 1, 2020) reported the prevalence of
SARS-CoV-2 antibodies in healthcare employees from the Northwell Health
System in the greater New York City area. The healthcare employees were
offered free, voluntary testing at each of the system's 52 sites
between April 20 and June 23, 2020. The analysis included 40,329 of the
system's 70,812 employees and found that 5,523 (13.7%) were
seropositive. The prevalence of SARS-CoV-2 antibodies was similar to
that found in randomly-tested adults in New York State at that time
(14%). Analysis of seropositivity by job type reported the highest
levels of seropositivity (20.9%) in service maintenance staff
(including housekeepers, groundskeepers, medical assistants, and 21
others), followed by 13.1% in nurses, 12.6% in administrative and
clerical staff (including non-clinical professionals such as employees
in information technology, human resources, medical records, and
billing); 11.6% in allied health professionals (including clinical
professionals such as physician assistants, physical therapists/
occupational therapists, social workers, mental health professionals,
pharmacists, and laboratory technicians), and 8.7% in physicians.
Seropositivity rates were highest in employees from the emergency
department and non-ICU hospital units (approximately 17% each),
followed by ``other'' non-specified areas (12.1%), and ICUs (9.9%).
Wilkins et al., (2021) conducted a cross-sectional study to examine
seropositivity rates in 6,510 healthcare workers from a Chicago
healthcare system consisting of hospitals, immediate care centers, and
outpatient practices. Blood samples were collected through July 8,
2020. The study authors then compared the seropositivity rate of
different occupational groups of workers, using administrators as the
referent group to reflect exposure consistent with non-healthcare
workers. Overall seropositivity for all study participants was 4.8%.
Before adjusting for demographics and self-reported out-of-hospital
exposure to COVID-19, the study found that a number of healthcare
occupations had a higher crude prevalence rate than the administrator
group, including: 10.4% for support service healthcare workers; 10.1%
for medical assistants; 9.3% for respiratory technicians; 7.6% for
nurses; and 3.8% for administrators. After adjustment for demographics
and self-reported out-of-hospital exposure to COVID-19, the only type
of healthcare workers that continued to be significantly more likely to
be seropositive than administrators were nurses, who were 1.9 times
more likely to be seropositive. The study authors concluded that the
higher work-related risk in nurses likely occurred as a result of
frequent and close contact with patients. The study also compared
seropositivity rates for different occupational tasks and found that
adjusted seropositivity rates were higher for workers participating in
the care of COVID-19 patients when compared with those who did not
report participating in the care of COVID-19 patients. Being exposed to
patients receiving high-flow oxygen therapy and hemodialysis was
significantly associated with 45% and 57% higher odds for seropositive
status, respectively.
Comparison of Healthcare Worker Serology and the Surrounding Community
Although some serology studies suggest that infections are more
correlated to community transmission than job designation (Jacob et
al., March 10, 2021; Carter et al., May 2021), these studies do not
undermine the robust evidence that healthcare employees with potential
workplace exposure to patients with suspected or confirmed COVID-19 are
exposed to an elevated risk of contracting COVID-19 compared
to the general population. Carter et al., (May 2021) found that
healthcare worker infection rates varied from region to region, noting
the importance of community transmission as a factor in infection
rates. In Jacob et al., (March 10, 2021), health care workers' serology
results were compared to residence location, job designation, and other
characteristics to identify risk factors. The study authors found that
community transmission was a significant factor in acquiring
infections, but were not able to tie in any specific job designation
resulting in increases in infection risk. The authors note, however,
that the study did not show that workplace exposures did not increase
risk; rather it showed that the levels of community transmission
observed may be a greater driver of transmission. It should also be
noted that the non-pharmaceutical interventions for each job
classification are different, so a direct comparison of non-clinical
and clinical personnel may result in conclusions with limited
application.
One might expect that a full shift with fully and properly
implemented non-pharmaceutical interventions should result in lower
infection rates. This appeared evident in a study comparing infection
rates between first and second COVID-19 outbreak surges in Norway
(Magnusson et al., January 6, 2021). For instance, during the first
wave from February 26, 2020 to July 17, 2020, nurses were almost three
times more likely to be infected than those in a similar age range (20
to 70 years old). However, during the second wave from July 18, 2020 to
December 18, 2020, infection rates for nurses were largely
indistinguishable from the population at large of a similar age. The
authors suggested that the decrease in the odds ratio was potentially
due to the implementation of appropriate infection control practices
that were previously lacking.
Studies Examining Risks After Known Exposures
Heinzerling et al., (April 17, 2020) examined the development of
COVID-19 in 120 healthcare employees who were unknowingly exposed to a
patient with COVID-19. The patient was later identified as one of the
first U.S. community cases of COVID-19, and Heinzerling et al., (April
17, 2020) concluded that the ``investigation presented a unique
opportunity to analyze exposures associated with SARS-CoV-2
transmission in a healthcare setting without recognized community
exposures.'' Of the 120 healthcare employees who were exposed, 43
developed symptoms within 14 days of exposure and were tested for
COVID-19. Three of those employees (7% of those tested) were positive
for COVID-19. Although those three employees represent 2.5% of the
total exposed, it is possible that more employees might have developed
COVID-19 because asymptomatic employees were not tested. The healthcare
employees who became infected, when compared to those who were not
infected, were more commonly present during two aerosol-generating
procedures (nebulizer treatment (67% vs. 9%) and non-invasive
ventilation (67% vs. 12%); more commonly performed physical
examinations of the patient (100% vs. 24%); and were exposed to the
patient for longer durations of time (median 120 minutes vs. 25
minutes). None of the exposed healthcare employees had been wearing the
complete set of PPE recommended for contact with COVID-19 patients.
Long-Term Care Facilities
Long-term care facilities include nursing homes, skilled nursing
facilities, and assisted living facilities. They provide both medical
and personal care services to people unable to live independently.
Because long-term care facilities are a congregate living situation,
infections such as COVID-19 can spread rapidly between patients or
residents and the healthcare staff who care for them. Therefore,
employees who work at these facilities have an elevated risk of
exposure and infection. Like employees who work at hospitals, employees
who work at long-term care facilities include both healthcare
practitioners, who may have direct and close contact with patients and
residents, as well as healthcare support staff who could also be
exposed to patients and residents. See the section on ``Detection of
SARS-CoV-2 in Healthcare Employees'' above for a description of the
types of employees who may work at these facilities.
McMichael et al., (March 27, 2020) investigated a COVID-19 outbreak
affecting patients, employees, and visitors at a long-term care
facility in King County, Washington in February of 2020. SARS-CoV-2
infections were identified in 129 persons, including 81 residents, 34
of 170 staff (20%), and 14 visitors. None of the employees died, but 2
of the 34 infected employees (5.9%) had symptoms severe enough to
require hospitalization. The median age of the employees was 42.5 years
(range 22-79 years). Job titles reported for the employees that were
infected included physical therapist, occupational therapist assistant,
environmental care worker, nurse, certified nursing assistant, health
information officer, physician, and case manager. The study authors
noted that infection prevention procedures at the facility were
insufficient, and they concluded that introduction of SARS-CoV-2 into
long-term care facilities will result in high attack rates among
residents, staff, and visitors.
Weil et al., (September 1, 2020) reported a cross-sectional study
of skilled nursing facilities in the Seattle area between March 29 and
May 13, 2020. Testing was performed by Public Health of Seattle and
King County (testing of both residents and staff) or the Seattle Flu
Study (testing of only employees). The authors described the period of
the study to be at the peak of the pandemic, but the skilled nursing
facilities were not experiencing outbreaks at the time of the study.
Testing of employees for SARS-CoV-2 was voluntary, and 1,583 employees
at 16 skilled nursing facilities were tested. Eleven of the 16 skilled
nursing facilities had at least one resident or employee who tested
positive. Forty-six (2.9%) employees had positive or inconclusive
testing for SARS-CoV-2. Of 1208 residents tested, 110 (9.1%) were
positive. Study authors noted shortages in PPE.
Yi et al., (September 7, 2020) evaluated surveillance data on
COVID-19 for assisted living facilities in 39 states (representing 44%
of the total long-term care facilities in the U.S.). The states began
reporting data at various periods ranging from February 27 to April 30,
2020. As of October 15, 2020, 6,440 of 28,623 (22%) assisted living
facilities had at least one COVID-19 case among residents or staff
(ranging from 1.3% of assisted living facilities in Iowa to 92.8% of
assisted living facilities in Connecticut). In 22 states, 17,799 cases
of COVID-19 were reported in staff (total number of staff not
specified). In 9 states, 46 of 7,128 (0.6%) employees with COVID-19
died.
Bagchi et al., (2021) reported on the CDC's National Healthcare
Safety Network (NHSN) surveillance of nursing homes, which began on
April 26, 2020. As of May 25, 2020, the Centers for Medicare & Medicaid
Services (CMS) began requiring nursing homes to report COVID-19 cases
in residents and staff. The authors analyzed data in residents, nursing
home staff, and facility personnel that was reported from May 25
through November 22, 2020 in all 50 states, the District of Columbia,
Guam, and Puerto Rico. Staff members and facility personnel were
defined as ``all persons working or volunteering in the facility,
including contractors,
temporary staff members, resident caregivers, and staff members who
might work at multiple facilities.'' The study authors reported that
``case count data were aggregated weekly, and resident-weeks were
calculated as the total number of occupied beds on the day data were
reported.'' Data on number of staff members employed were not
collected, and therefore ``resident weeks'' was used as ``a closest
best estimate of the at-risk denominator for staff members.'' The study
authors indicated that ``cases per 1,000 resident-week were calculated
for residents and staff members using the number of COVID-19 cases
reported in a week over the corresponding 1,000 resident-weeks.''
COVID-19 cases in staff members increased during June and July (10.9
cases per 1,000 resident-weeks reported in the week of July 26);
declined during August and September (6.3 per 1,000 resident-weeks in
the week of September 13); and increased again by late November (21.3
cases per 1,000 resident-weeks in the week of November 22). The study
authors noted that COVID-19 rates among nursing home staff followed
similar trends in nursing home residents and the surrounding
communities, thereby indicating a possible association between COVID-19
rates in nursing homes and nearby communities.
Terebuh et al., (September 20, 2020) investigated COVID-19 clusters
in 45 congregate living facilities in Ohio, from March 7 to May 15,
2020. Most of the facilities investigated were healthcare worksites.
More than half of the clusters occurred at medical facilities (51% at
nursing homes, 11% at assisted living facilities, 7% at treatment
facilities, and 2% at intermediate care facilities). The remaining
clusters occurred at corrections facilities (7%), group homes (20%),
and shelters (2%). Of the combined 598 residents and healthcare
employees who were either confirmed to have COVID-19 or identified as a
probable case based on symptoms and close contact with a confirmed
case, healthcare employees represented 167 (28%) of the confirmed and
37 (6%) of the probable cases of COVID-19. None of the healthcare
employees died. The study authors were able to identify the index case
in 25 of the clusters, and 88% of the index cases were determined to be
healthcare employees.
Studies Focusing on Healthcare Support Services
Healthcare support services employees, such as personnel that
provide food, laundry, or waste-handling services, are at risk of
exposure to patients with SARS-CoV-2 and contracting COVID-19.
Employees who provide healthcare support services usually have less
direct contact with patients, but they can have close contact with
COVID-19 patients or contaminated materials when performing tasks such
as cleaning patient rooms, removing waste or dirty laundry from patient
rooms, delivering food and picking up used food trays and utensils, or
repairing equipment in the patient's room. In addition, healthcare
support employees can have close and prolonged contact with their co-
workers while performing their duties.
One study discussed above (Sims et al., November 5, 2020), shows an
infection rate among healthcare support services employees that is
similar to healthcare employees, such as physicians, who have some
patient contact. As noted, support personnel such as facilities/
security and administrative support employees had seropositivity rates
of approximately 7% to 8%, which were similar to rates in physicians
(values estimated from Figure 2B). Both healthcare support employees
and physicians had seropositivity rates that were higher than the rates
among employees working from home.
Hale and Dayot (2020) examined an outbreak of COVID-19 among food
service employees that occurred in an academic medical center before
masking and physical distancing requirements were implemented. After an
employee in the food and nutrition department tested positive, 280
asymptomatic staff were tested. The entire food and nutrition
department that was actively working was considered exposed because
employees shared a common locker room and break area. Therefore,
testing was not limited to employees who worked near the index case as
part of their duties. Ten staff members in the department (including
the index case) tested positive during the investigation. At least
seven of the cases were thought to result from transmission from the
index case.
Outbreaks for support services have not been well documented and
may be encapsulated with incidents for the entire hospital. Local
newspaper reports have identified potential incidents in laundry
facilities that handle linens contaminated with SARS-CoV-2. In a New
Jersey unionized laundry facility, representatives noted that eight
employees had been infected with SARS-CoV-2 and demanded improvements
in infectious disease control implementation (Davalos, December 21,
2020). In Canada, a Regina hospital laundry plant was connected with an
18-employee outbreak (Martin, August 10, 2020). The cause of the
outbreak was not determined.
Emergency Medical Services (EMS)
A limited number of studies have examined the impact of COVID-19 on
employees who provide EMS (e.g., EMTs, paramedics), who are considered
healthcare personnel under this standard. The studies that address EMS
often address personnel such as EMTs along with other types of
emergency responders such as firefighters, who are not considered
healthcare personnel under this standard. EMTs and similar occupations,
such as paramedics, have close contact with patients who are or could
be infected with SARS-CoV-2 when they provide medical care or transport
those patients. The medical care they provide includes intubation and
cardiopulmonary resuscitation, which could generate aerosols and put
them at particularly high risk when performing those procedures on
someone with confirmed or suspected COVID-19.
Prezant et al., (2020) reviewed paid medical leave data for EMS
providers and firefighters using New York City fire department
electronic medical records from October 1, 2017 through May 31, 2020.
The study authors found that as of May 31, 2020, 1,792 of 4,408 EMS
providers (40.7%) had been on leave for suspected or confirmed COVID-
19. When compared with the medical leave data from before the
pandemic--including months during influenza periods in prior years--the
authors found that medical leave for EMS providers was 6.8% above
baseline in March 2020 and peaked at 19.3% above baseline in April
2020. The authors determined that COVID-19 was responsible for this
increase. The medical leave levels for EMS providers were above those
for firefighters. Among firefighters, the data showed that 34.5% had
been on leave for suspected or confirmed COVID-19 as of May 31, 2020,
and there was a peak in medical leave at 13.0% above baseline in April
2020. A total of 66 (1.2%) firefighters and EMS providers with COVID-19
were hospitalized and 4 died. Despite EMS providers having been given
the same PPE (not further specified) as firefighters, EMS providers had
higher rates of COVID-19. The study authors concluded that higher rates
in EMS providers were attributable to greater exposure to COVID-19
patients while administering medical care.
Weiden et al., (January 25, 2021) investigated risk factors for
SARS-CoV-2 infection and severe disease (hospitalization or death) in
New York City first responders (EMS and
firefighters) from March 1 through May 31, 2020, based on medical
records. The study had a total of 14,290 participants (3,501 EMS
personnel and 10,789 firefighters). From March 1 to May 31, 2020, 9,115
(63.8%) responders had no COVID-19 diagnosis, 5,175 (36.2%) were
confirmed or suspected COVID-19 cases, and 62 (0.4%) were hospitalized.
Three participants died in a hospital, and one died at home.
Researchers found that EMS respondents had more cases of severe COVID-
19 than firefighters (42/3501 [1.2%] vs. 21/10,789 [0.19%]). The SARS-
CoV-2 infection rate among New York City first responders overall was
15 times the New York City rate. EMS personnel had a 4-fold greater
risk of severe disease and 26% increased risk of confirmed COVID-19
cases when compared with firefighters. Both firefighters and EMS
personnel responded to the pandemic-related emergency medical calls and
followed the same PPE protocols. However, EMS personnel had greater
COVID-19 exposure than firefighters due to greater COVID-19-related
call volume and being solely responsible for patient transport,
nebulization of bronchodilators, and intubation.
Tarabichi et al., (October 30, 2020) recruited first responders
(from EMS and fire departments) to participate in a study in the
Cleveland, Ohio area. The authors conducted a first serologic survey
and virus test in the period between April 20 through May 19, 2020 and
a second between May 18 and June 2, 2020. A total of 296 respondents
completed a first visit and 260 completed the second visit. Seventy-one
percent of respondents reported exposure to SARS-CoV-2 and 16 (5.4%)
had positive serological testing. No subject had a positive virus test.
Fifty percent (8/16) of those who tested positive were either
asymptomatic or mildly symptomatic. Based on responses to questions
about suspected contacts (it does not appear that the time period of
exposure was considered), the study author concluded that likely
sources of transmission in participants who tested positive were
patients or co-workers.
In a study examining COVID-19 antibodies in employees from public
service agencies in the New York City area from May through July of
2020, 22.5% of participants were found to have COVID-19 antibodies
(Sami et al., March 2021). The percentages of EMTs and paramedics found
to have antibodies (38.3 and 31.1%) were among the highest levels
observed in all the occupations. The study authors noted that risk of
exposures may be increased for employees who provide emergency medical
services because those services are provided in uncontrolled,
unpredictable environments, where space is limited (e.g., ambulances)
and quick decisions must often be made. Both emergency technicians and
paramedics perform procedures such as airway management that involve a
high risk of exposure. In fact, the proportions of employees who had
antibodies were found to be increased with increasing frequency of
aerosol-generating procedures.
In-Home Healthcare Providers
In-home healthcare workers provide medical or personal care
services, similar to those provided in long-term care facilities,
inside the homes of people unable to live independently. Patients
receiving in-home care could receive services from different types of
healthcare providers (e.g., a nurse administering medical care, a
physical therapist assisting with exercise, a personal care services
provider assisting with daily functions such as bathing). In addition,
a number of workers may provide services to the same patient, while
working in shifts over the course of the day. In-home healthcare
providers have a high risk of infection from working close to patients
and possibly their family members or other caregivers in enclosed
spaces (e.g., performing a physical examination, helping the patient
bathe).
The impact of COVID-19 on in-home healthcare workers is not well
studied. In-home healthcare workers might be included in reports of
COVID-19 cases and deaths in healthcare workers, but those reports do
not indicate if any of the affected healthcare workers provided home
care. One report from the UK indicated that an occupational category of
``social care'' which included ``care workers and home carers''
experienced significantly increased rates of death involving COVID-19
(50.1 deaths per 100,000 men and 19.1 deaths per 100,000 women) from
March through May of 2020 (Windsor-Shellard et al., June 26, 2020). And
in a related study from March through December of 2020, it was reported
that nearly three in four deaths involving COVID-19 in social care
operations were in ``care workers and home carers,'' with 109.9 deaths
per 100,000 men and 47.1 deaths per 100,000 women (Windsor-Shellard et
al., January 25, 2021).
Conclusion
The representative studies OSHA described in this section on
healthcare provide examples of the pervasive impact that SARS-CoV-2
exposures have had on employees in those industries before vaccines
were available. Even since vaccines have become widely available,
approximately 20 to 30% of healthcare workers remained unvaccinated as
of March 2021 (King et al., April 24, 2021), and breakthrough cases
among vaccinated healthcare employees are evident. The evidence is
consistent with OSHA's determination that SARS-CoV-2 poses a grave
danger to healthcare employees. Cases or outbreaks in settings such as
hospitals, long-term care facilities, and emergency services
departments have had a clear impact on employees in those types of
workplaces. The evidence establishes that employees in those settings,
whether they provide direct patient care or supporting services, have
been infected with SARS-CoV-2 and have developed COVID-19. Some of
these employees have died and others have become seriously ill.
Employees in healthcare are at elevated risk for transmission in the
workplace. Employees in these industry settings are exposed to these
forms of transmission through in-person interaction with patients and
co-workers in settings where individuals with suspected or confirmed
COVID-19 receive care. In many cases, close contact with people who are
suspected or confirmed to have COVID-19 is required of personnel in
these types of workplaces, and such close contact usually occurs
indoors. These employees, who form the backbone of the nation's medical
response to the COVID-19 public health emergency, clearly require
protection under this ETS.
References
Bagchi, S et al., (2021). Rates of COVID-19 among residents and
staff members in nursing homes--United States, May 25-November 22,
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(Bagchi et al., 2021).
Barrett, ES et al., (2020). Prevalence of SARS-CoV-2 infection in
previously undiagnosed health care workers in New Jersey, at the
onset of the US COVID-19 pandemic. BMC infectious diseases 20(1): 1-
0. doi: 10.1101/2020.04.20.20072470. (Barrett et al., 2020).
Burrer, SL et al., (2020). Characteristics of health care personnel
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69(15): 477-481. https://www.cdc.gov/mmwr/volumes/69/wr/mm6915e6.htm. (Burrer et al., 2020).
Carter, RE et al., (2021, March 26). Prevalence of SARS-CoV-2
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Centers for Disease Control and Prevention (CDC). (2020, July, 6).
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2020).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
Cases & Deaths among Healthcare Personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel. (CDC, May 24, 2021a).
Davalos, J. (2020, December 21). Hospital laundry workers fear their
infection risk is rising. Bloomberg. https://www.bloomberg.com/news/articles/2020-12-21/hospital-laundry-workers-say-every-day-at-work-risks-covid-infection. (Davalos, December 21, 2020).
Fell, A et al., (2020, October 30). SARS-CoV-2 exposure and
infection among health care personnel--Minnesota, March 6-July 11,
2020. MMWR 69(43): 1605-1610. https://www.cdc.gov/mmwr/volumes/69/wr/mm6943a5.htm?s_cid=mm6943a5_x. (Fell et al., October 30, 2020).
Firew, TS et al., (2020). Protecting the front line: A cross-
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the COVID-19 pandemic in the USA. BMJ Open 10(10). doi: 10.1136/
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Hale, M and Dayot, A. (2020). Outbreak investigation of COVID-19 in
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Hartmann, S et al., (2020). Coronavirus 2019 (COVID-19) Infections
among healthcare workers, Los Angeles County, February-May 2020.
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Heinzerling, A et al., (2020, April 17). Transmission of COVID-19 to
health care personnel during exposures to a hospitalized patient--
Solano County, California, February 2020. MMWR 69(15): 472-476.
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Jacob, JT et al., (2021, March 10). Risk Factors Associated With
SARS-CoV-2 Seropositivity Among US Health Care Personnel. JAMA Netw
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(Jacob et al., March 10, 2021).
Kaiser Health News and the Guardian. (2021, February 23). Lost on
the Frontline. The Guardian. https://www.theguardian.com/us-news/ng-interactive/2020/aug/11/lost-on-the-frontline-covid-19-coronavirus-us-healthcare-workers-deaths-database. (Kaiser Health News and the
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Kaiser Health News and the Guardian. (2021, April). Lost on the
Frontline. The Guardian. https://www.theguardian.com/us-news/ng-interactive/2020/aug/11/lost-on-the-frontline-covid-19-coronavirus-us-healthcare-workers-deaths-database. (Kaiser Health News and the
Guardian, April 2021).
King, WC et al., (2021, April 24). COVID-19 vaccine hesitancy
January-March 2021 among 18-64 year old US adults by employment and
occupation. medRxiv; https://www.medrxiv.org/content/10.1101/2021.04.20.21255821v3. (King et al., April 24, 2021).
Magnusson, K et al., (2021, January 6). Occupational risk of COVID-
19 in the 1st and 2nd wave of infection. medRxiv https://doi.org/10.1101/2020.10.29.20220426. (Magnussen et al., January 6, 2021).
Mani, NS et al., (2020, November 15). Prevalence of COVID-19
infection and outcomes among symptomatic healthcare workers in
Seattle, Washington. Clin Infectious Disease 71(10): 2702-2707. doi:
10.1093/cid/ciaa761. (Mani et al., November 15, 2020).
Martin, A. (2020, August 10). Outbreak at Regina's K-Bro Linens: 18
employees test positive. Regina Leader-Post. https://leaderpost.com/news/local-news/outbreak-at-reginas-k-bro-linens-18-employees-test-positive. (Martin, August 10, 2020).
McMichael, TM et al., (2020, March 27). Epidemiology of Covid-19 in
a long-term care facility in King County, Washington. New England
Journal of Medicine 382(21): 2005-2011. doi: 10.1056/NEJMoa2005412.
(McMichael et al., March 27, 2020).
Misra-Hebert, AD et al., (2020, September 1). Impact of the COVID-19
pandemic on healthcare workers' risk of infection and outcomes in a
large, integrated health system. Journal of General Internal
Medicine 35: 3293-3301. https://doi.org/10.1007/s11606-020-06171-9.
(Misra-Hebert et al., September 1, 2020).
Moscola, J et al., (2020, September 1). Prevalence of SARS-CoV-2
antibodies in health care personnel in the New York City Area. JAMA
324(9): 893-895. doi: 10.1001/jama.2020.14765. (Moscola et al.,
September 1, 2020).
Nagler, AR et al., (2020, June 28). Early results from SARS-CoV-2
PCR testing of healthcare workers at an academic medical center in
New York City. Clinical Infectious Diseases 72(7): 1241-1243. doi:
10.1093/cid/ciaa867. (Nagler et al., June 28, 2020).
Nguyen, LH et al., (2020). Risk of COVID-19 among front-line health-
care workers and the general community: a prospective cohort study.
The Lancet Public Health 5(9): e475-e483. https://doi.org/10.1016/S2468-2667(20)30164-X. (Nguyen et al., 2020).
Prezant, DJ et al., (2020). Medical leave associated with COVID-19
among emergency medical system responders and firefighters in New
York City. JAMA Netw Open 3(7). https://doi.org/10.1001/jamanetworkopen.2020.16094. (Prezant et al., 2020).
Sami, S et al., (2021, March). Prevalence of SARS-CoV-2 antibodies
in first responders and public safety personnel, New York City, New
York, USA, May-July 2020. Emerging Infectious Diseases 27(3).
https://doi.org/10.3201/eid2703.204340. (Sami et al., March 2021).
Sims, MD et al., (2020). COVID-19 seropositivity and asymptomatic
rates in healthcare workers are associated with job function and
masking. Clinical Infectious Diseases. doi: 10.1093/cid/ciaa1684.
(Sims et al., November 5, 2020).
Tarabichi, Y et al., (2020, October 30). SARS-CoV-2 infection among
serially tested emergency medical services workers. Prehospital
Emergency Care 25(1): 39-45. https://doi.org/10.1080/10903127.2020.1831668. (Tarabichi et al., October 30, 2020).
Terebuh et al., (2020, September 20). Characterization of community-
wide transmission of SARS-CoV-2 in congregate living settings and
local public health-coordinated response during the initial phase of
the COVID-19 pandemic. Influenza Other Respir Viruses. doi: 10.1111/
irv.12819. (Terebuh et al., September 20, 2020).
Vahidy, FS et al., (2020) Prevalence of SARS-CoV-2 infection among
asymptomatic health care workers in the greater Houston, Texas,
area. JAMA Network Open 3(7): e2016451. https://doi.org/10.1001/jamanetworkopen.2020.16451. (Vahidy et al., 2020).
Venugopal, U et al., (2020, January). SARS-CoV-2 seroprevalence
among health care workers in a New York City hospital: A cross-
sectional analysis during the COVID-19 pandemic. International
Journal of Infectious Diseases 102: 63-69. https://doi.org/10.1016/j.ijid.2020.10.036. (Venugopal et al., January 2020).
Weiden, M et al., (2021, January 25). Pre-COVID-19 lung function and
other risk factors for severe COVID-19 in first responders. ERJ open
research 7(1): 00610-2020. https://doi.org/10.1183/23120541.00610-2020. (Weiden et al., January 25, 2021).
Weil, A et al., (2020, September 1). Cross-sectional prevalence of
SARS-CoV-2 among skilled nursing facility employees and residents
across facilities in Seattle. J Gen Intern Med 35: 11. doi: 10.1007/
s11606-020-06165-7. (Weil et al., September 1, 2020).
Wilkins, JT et al., (2021). Seroprevalence and correlates of SARS-
CoV-2 antibodies in health care workers in Chicago. Open Forum
Infectious Diseases 8(1). https://doi.org/10.1093/ofid/ofaa582.
(Wilkins et al., 2021).
Windsor-Shellard, B and Butt, A. (2020, June 26). Coronavirus
(COVID-19) related deaths by occupation, England and Wales: deaths
registered between 9 March and 25 May 2020. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/causesofdeath/bulletins/coronaviruscovid19relateddeathsbyoccupationenglandandwales/deathsregisteredbetween9marchand25may2020.
(Windsor-Shellard and Butt, June 26, 2020).
Windsor-Shellard, B and Nasir, R. (2021, January 25). Coronavirus
(COVID-19) related deaths by occupation, England and Wales: deaths
registered between 9 March and 28 December 2020. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/causesofdeath/bulletins/coronaviruscovid19relateddeathsbyoccupationenglandandwales/deathsregisteredbetween9marchand28december2020. (Windsor-Shellard
and Nasir, January 25, 2021).
Yi, H et al., (2020, September 7). Health equity considerations in
COVID-19: geospatial network analysis of the COVID-19 outbreak in
the migrant population in Singapore. J Travel Med. DOI: 10.1093/jtm/
taaa159. (Yi et al., September 7, 2020).
IV. Conclusion
OSHA finds that healthcare employees face a grave danger from
exposure to SARS-CoV-2 in the United States.\10\ OSHA's determination
is based on three separate manifestations of incurable, permanent, or
non-fleeting health consequences of exposure to the virus, each of
which is independently supported by substantial evidence in the record.
The danger to healthcare employees is further supported by powerful
lines of evidence demonstrating the transmissibility of the virus in
the workplace and the prevalence of infections in employee populations
where individuals with suspected or confirmed COVID-19 receive care.
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\10\ The determination that COVID-19 presents a grave danger to
healthcare employees is not based on a determination that workplace
protections previously adopted by any particular employer to address
the risk of infection are necessarily inadequate. As discussed in
the Feasibility section, many such workplace protections are
consistent with the uniform nationwide requirements set forth in the
ETS. The purpose of the ETS is to ensure sufficient protections for
workers are consistently implemented across the country.
---------------------------------------------------------------------------
First, with respect to the grave health consequences of exposure to
SARS-CoV-2, OSHA has found that regardless of where and how exposure
occurs, COVID-19 can result in death. The risk of death from COVID-19
is especially high for employees who have underlying health conditions,
older employees, and employees who are members of racial and ethnic
minority groups, who together make up a significant proportion of the
working population. Second, even for those who survive a SARS-CoV-2
infection, the virus often causes serious, long-lasting, and
potentially permanent health effects. Serious cases of COVID-19 require
hospitalization and dramatic medical interventions, and might leave
employees with permanent and disabling health effects. Third, even mild
or moderate cases of COVID-19 that do not require hospitalization can
be debilitating and require medical care and significant time off from
work for recovery and quarantine. People who initially appear to have
mild cases can suffer health effects that continue months after the
initial infection. Furthermore, racial and ethnic minority groups are
at increased risk of SARS-CoV-2 infection, as well as hospitalization
and death from COVID-19.
Each of these categories of health consequences independently poses
a grave danger to individuals exposed to the virus. That danger is
amplified for healthcare employees because of the high potential for
transmission of the virus in healthcare settings where individuals with
suspected or confirmed COVID-19 receive care. The best available
evidence on the science of transmission of the virus makes clear that
SARS-CoV-2 is transmissible from person to person in these settings,
which can result in large-scale clusters of infections. Transmission is
most prevalent in healthcare settings where individuals with suspected
or confirmed COVID-19 receive care, and can be exacerbated by, for
example, poor ventilation, close contact with potentially infectious
individuals, and situations where aerosols containing SARS-CoV-2
particles are likely to be generated. Importantly, while older
employees and those with underlying health conditions face a higher
risk of dying from COVID-19 once infected, fatalities are certainly not
limited to that group. Every healthcare workplace exposure or
transmission has the potential to cause severe illness or even death,
particularly in unvaccinated healthcare workers in settings where
patients with suspected or confirmed COVID-19 receive care. Taken
together, the multiple, severe health consequences of COVID-19 and the
evidence of its transmission in environments characteristic of the
healthcare workplaces where this ETS requires worker protections
demonstrate that exposure to SARS-CoV-2 represents a grave danger to
employees in these workplaces throughout the country.\11\
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\11\ Note that OSHA has made no determination regarding the
significance of the risk to employees from exposure to SARS-CoV-2,
as would be required in a permanent rulemaking under section 6(b)(5)
of the OSH Act, 29 U.S.C. 655(b)(5). OSHA has only considered
whether exposure to SARS-CoV-2 poses a grave danger, as required for
promulgation of a permanent standard under section 6(c)(1)(A), 29
U.S.C. 655(c)(1)(A).
---------------------------------------------------------------------------
The existence of a grave danger to employees from SARS-CoV-2 is
further supported by the toll the pandemic has already taken on the
nation as a whole. Although OSHA cannot estimate the total number of
healthcare workers in our nation who contracted COVID-19 at work and
became sick or died, COVID-19 has killed 587,342 people in the United
States as of May 24, 2021 (CDC, May 24, 2021a). That death toll
includes 91,351 people who were 18 to 64 years old (CDC, May 24,
2021b). Current mortality data shows that unvaccinated people of
working age have a 1 in 217 chance of dying when they contract COVID-
19. As of May 24, 2021, more than 32 million people in the United
States have been reported to have infections, and thousands of new
cases were being identified daily (CDC, May 24, 2021c). One in ten
reported cases of COVID-19 becomes severe and requires hospitalization.
Moreover, public health officials agree that these numbers fail to show
the full extent of the deaths and illnesses from this disease, and
racial and ethnic minority groups are disproportionately represented
among COVID-19 cases, hospitalizations, and deaths (CDC, December 10,
2021; CDC, May 26, 2021; Escobar et al., 2021; Gross et al., 2020;
McLaren, 2020). Given this context, OSHA is confident in its finding
that exposure to SARS-CoV-2 poses a grave danger to the healthcare
employees covered by the protections in this ETS.
The above analysis fully satisfies the OSH Act's requirements for
finding a grave danger. Although OSHA usually performs a quantitative
risk assessment before promulgating a health standard under section
6(b)(5) of the OSH Act, 29 U.S.C. 655(b)(5), that type of analysis is
not necessary in this situation. OSHA has most often invoked section
6(b)(5) authority to regulate exposures to chemical hazards involving
much smaller populations, many fewer cases, extrapolations from animal
evidence, long-term exposure, and delayed effects. In those situations,
mathematical modelling is necessary to evaluate the extent of the risk
at different exposure levels. The gravity of the danger presented by a
disease with acute effects like COVID-19, on the other hand, is made
obvious by a straightforward count of deaths and illnesses caused by
the disease, which reach sums not seen in a century. The evidence
compiled above amply support OSHA's finding that SARS-CoV-2 presents a
grave danger in to the healthcare employees covered by the protections
in this ETS. In the context of ordinary 6(b) rulemaking, the Supreme
Court has said
that the OSH Act is not a ``mathematical straitjacket,'' nor does it
require the agency to support its findings ``with anything approaching
scientific certainty,'' particularly when operating on the ``frontiers
of scientific knowledge.'' Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 656, 100 S. Ct. 2844, 2871, 65 L. Ed. 2d 1010
(1980). This is true a fortiori here in the current national crisis
where OSHA must act to ensure employees are adequately protected from
the new hazard presented by the COVID-19 pandemic (see 29 U.S.C
655(c)(1)).
Having made the determination of grave danger, as well as the
determination that an ETS is necessary to protect these employees from
exposure to SARS-CoV-2 (see Need for the ETS, in Section IV.B. of this
preamble), OSHA is required to issue this standard to protect these
employees from getting sick and dying from COVID-19 acquired at work.
See 29 U.S.C. 655(c)(1).
References
Centers for Disease Control and Prevention (CDC). (2020, December
10). COVID-19 racial and ethnic health disparities. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/racial-ethnic-disparities/index.html. (CDC, December 10, 2020).
Centers for Disease Control and Prevention (CDC). (2021, May 26).
Health disparities: race and Hispanic origin. https://www.cdc.gov/nchs/nvss/vsrr/covid19/health_disparities.htm. (CDC, May 26, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
COVID data tracker.Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
Demographic Trends of COVID-19 cases and deaths in the US reported
to CDC: Deaths by age group. https://covid.cdc.gov/covid-data-tracker/#demographics. (CDC, May 24, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
COVID data tracker.Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.(CDC, May 24, 2021c).
Escobar, GJ et al., (2021, February 9). Racial disparities in COVID-
19 testing and outcomes. Annals of Internal Medicine. doi: 10.7326/
M20-6979. (Escobar et al., February 9, 2021).
Gross, CP et al., (2020, October). Racial and ethnic disparities in
population-level COVID-19 mortality. Journal of General Internal
Medicine 35(10): 3097-3099. doi: 10.1007/s11606-020-06081-w. (Gross
et al., October 2020).
McLaren, J. (2020, June). Racial disparity in COVID-19 deaths:
Seeking economic roots with Census data. NBER Working Paper Series.
Working Paper 27407. doi: 10.3386/w27407. (McLaren, June 2020).
B. Need for the ETS
This ETS is necessary to protect the healthcare workers with the
highest risk of contracting COVID-19 at work. Healthcare workers face a
particularly elevated risk of contracting COVID-19 in settings where
patients with suspected or confirmed COVID-19 receive treatment,
especially those healthcare workers providing direct care to patients.
The ETS is necessary to protect these workers through requirements
including patient screening and management, respirators and other
personal protective equipment (PPE), limiting exposure to aerosol-
generating procedures, physical distancing, physical barriers,
cleaning, disinfection, ventilation, health screening and medical
management, access to vaccination, and anti-retaliation provisions and
medical removal protection.
I. Events Leading to the ETS
Since January 2020, OSHA has received numerous petitions and
supporting letters from members of Congress, unions, advocacy groups,
and one group of large employers urging the agency to take immediate
action by issuing an ETS to protect healthcare employees from exposure
to the virus that causes COVID-19 (Scott and Adams, January 30, 2020;
NNU, March 4, 2020; AFL-CIO, March 6, 2020; Wellington, March 12, 2020;
DeVito, March 12, 2020; Carome, March 13, 2020; Murray et al., April
29, 2020; Solt, April 28, 2020; Public Citizen, March 13, 2020;
Pellerin, March 19, 2020; Yborra, March 19, 2020; Owen, March 19, 2020;
ORCHSE, October 9, 2020). These petitions and supporting letters
asserted that many employees have been infected because of workplace
exposures to the virus that causes COVID-19 and immediate, legally
enforceable action is necessary for protection. OSHA quickly began
issuing detailed guidance documents and alerts beginning in March 2020
that helped employers determine employee risk levels of COVID-19
exposure and made recommendations for appropriate controls.
On March 18, 2020, then-OSHA Principal Deputy Assistant Secretary
Loren Sweatt responded to an inquiry from Congressman Robert C.
``Bobby'' Scott, Chairman of the House Committee on Education and
Labor, regarding OSHA's response to the COVID-19 outbreak (OSHA, March
18, 2020). In the letter, she stated that OSHA had ``a number of
existing enforcement tools'' it was using to address COVID-19,
including existing standards such as Personal Protective Equipment
(PPE), Respiratory Protection, and Bloodborne Pathogens, as well as the
General Duty Clause, 29 U.S.C. 654(a)(1). She also stated that OSHA was
working proactively to assist employers by developing guidance
documents. And, given the existing enforcement tools, ``we currently
see no additional benefit from an ETS in the current circumstances
relating to COVID-19,'' and ``OSHA can best meet the needs of America's
workers by being able to rapidly respond in a flexible environment.''
However, she noted that OSHA would continue to monitor ``this quickly
evolving situation and will take appropriate steps to protect workers
from COVID-19 in coordination with the overall U.S. government response
effort.''
Shortly after OSHA's announcement that it did not intend to pursue
an ETS at that time, the American Federation of Labor and Congress of
Industrial Organizations (AFL-CIO), the country's largest federation of
labor unions, filed an emergency petition with the U.S. Court of
Appeals for the D.C. Circuit, for a writ of mandamus to compel OSHA to
issue an ETS for COVID-19, arguing that OSHA's failure to issue legally
enforceable COVID-19-specific rules endangered workers (AFL-CIO, May
18, 2020). On May 29, 2020, OSHA denied the AFL-CIO's pending March 6
petition to OSHA for an ETS \12\ and simultaneously filed a response
brief with the D.C. Circuit, arguing the AFL-CIO was not entitled to a
writ of mandamus (DOL, May 29, 2020). The agency stated that the union
had not clearly and indisputably demonstrated that an ETS was necessary
and expressed its view that an ETS was not necessary at that time
because of the agency's two-pronged strategy for addressing COVID-19 in
the workplace:
Enforcement of existing standards and section 5(a)(1) of the OSH Act
(the General Duty Clause), as well as development of rapid guidance to
provide a flexible response to new and evolving information about the
virus. On June 11, 2020, the U.S. Court of Appeals for the D.C. Circuit
issued a one paragraph per curiam order denying the AFL-CIO's petition,
finding that OSHA's ``decision not to issue an ETS is entitled to
considerable deference,'' and ``[i]n light of the unprecedented nature
of the COVID-19 pandemic, as well as the regulatory tools that the OSHA
has at its disposal to ensure that employers are maintaining hazard-
free work environments, . . . OSHA reasonably determined that an ETS is
not necessary at this time.'' In re Am. Fed'n of Labor & Cong. of
Indus. Orgs., No. 20-1158, 2020 WL 3125324 (AFL-CIO, June 11, 2020),
rehearing en banc denied (AFL-CIO, July 28, 2020).\13\
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\12\ The AFL-CIO had petitioned OSHA on March 6 to issue an ETS
to protect working people from occupational exposure to infectious
diseases broadly, including COVID-19 (AFL-CIO, March 6, 2020). In
OSHA's May 29, 2020 denial, the agency concluded that it lacked
compelling evidence to find that an undefined category of infectious
diseases generally posed a grave danger for which an ETS was
necessary (OSHA, May 29, 2020). With respect to COVID-19
specifically, the agency made no conclusion as to whether the
disease posed a grave danger to workers, but concluded, as it had in
the earlier March 18, 2020 response to congressional inquiry, that a
COVID-19 ETS was not necessary at that time (id.).
\13\ On October 29, 2020, a group of petitioners including the
American Federation of Teachers (AFT), the American Federation of
State, County and Municipal Employees, the Washington State Nurses
Association, and the United Nurses Association of California/Union
of Health Care Professionals filed a separate petition for a writ of
mandamus from the U.S. Court of Appeals for the Ninth Circuit to
compel OSHA to issue a permanent standard to protect healthcare
workers from the risks of infectious diseases (AFT, October 29,
2020). On December 31, 2020, OSHA filed a response brief asserting
that the petitioners were not entitled to the requested writ of
mandamus (DOL, December 31, 2020). OSHA explained that, while the
agency has been considering the need for an infectious disease
standard for healthcare workers since at least 2009, it has not yet
made a final determination on the necessity of such a standard, and
that the agency's limited resources at this time are best directed
toward responding to the broader COVID-19 crisis. The Ninth Circuit
granted the parties' request to stay the case because OSHA now
intends to prioritize the infectious disease rulemaking.
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Following OSHA's decision in May 2020 not to issue an ETS, some
states and local health departments determined enforceable regulation
was necessary, leading to the adoption of a variety of state and local
executive orders and emergency regulations with specific worker
protection requirements. Virginia, Oregon, California, Michigan, and
Washington have issued their own ETSs, (see Section VII, Additional
Requirements, for a full discussion of OSHA-approved State Plans), and
many additional states and localities have issued other kinds of
requirements, guidelines, and protective ordinances for workers. Other
states and localities have not. The resulting patchwork of state and
local regulations led to inadequate and varying levels of protection
for workers across the country, and has caused problems for many
employees and businesses. As a result, on October 9, 2020, ORCHSE
Strategies, LLC (since acquired by the National Safety Council (NSC))--
a group of more than 100 large (mostly Fortune 500) companies in over
28 industries--petitioned OSHA to issue an ETS, recognizing that OSHA
had provided ``very well prepared and thoughtful'' guidance, but
concluding an ETS is still needed and that the lack of a uniform
response has caused confusion and unnecessary burden on already
struggling workplaces (ORCHSE, October 9, 2020).
Notwithstanding the patchwork efforts at the state and local level,
the country experienced a significant increase in COVID-19 deaths and
infections. When OSHA decided not to promulgate an ETS in May 2020, the
COVID-19 death toll in the United States was reaching 100,000 (CDC, May
28, 2020). Since then, an additional 500,000 Americans have died from
COVID-19 (CDC, May 24, 2021a). Despite a decrease in recent weeks, the
death rate remains high (7-day moving average death rate of 500 on May
23, 2021) (CDC, May 24, 2021b), and thousands of Americans are
hospitalized with COVID-19 every day (CDC, May 24, 2021c).
As of May 23, 2021, the agency had issued 689 citations for COVID-
19-related violations of existing OSHA requirements, primarily of
healthcare facilities including nursing homes. Violations have
included, among other things, failure to properly develop written
respiratory protection programs; failure to provide a medical
evaluation, respirator fit test, training on the proper use of a
respirator, and personal protective equipment; failure to report an
injury, illness, or fatality; failure to record an injury or illness on
OSHA recordkeeping forms; and failure to comply with the General Duty
Clause of the OSH Act. In addition, OSHA issued over 230 Hazard Alert
Letters (HALs), including over 100 HALs to employers in healthcare
settings (e.g., hospitals, ambulatory care, and nursing and residential
care facilities), where it found COVID-19-related hazards during
workplace inspections, but did not believe it had sufficient basis to
cite the employer for violating an existing OSHA standard or the
General Duty Clause.
On January 21, 2021, President Biden issued Executive Order 13999,
entitled ``Protecting Worker Health and Safety'' (86 FR 7211). In it,
he declared that:
Ensuring the health and safety of workers is a national priority
and a moral imperative. Healthcare workers and other essential
workers, many of whom are people of color and immigrants, have put
their lives on the line during the coronavirus disease 2019 (COVID-
19) pandemic. It is the policy of my Administration to protect the
health and safety of workers from COVID-19. The Federal Government
must take swift action to reduce the risk that workers may contract
COVID-19 in the workplace.
He further directed OSHA to take a number of steps to better
protect workers from the COVID-19 hazard, including issuing revised
guidance on workplace safety, launching a national emphasis program to
focus OSHA enforcement efforts on COVID-19, conduct a multilingual
outreach program, and evaluate its COVID-19 enforcement policies (id.).
In addition, the President directed OSHA to ``consider whether any
emergency temporary standards on COVID-19, including with respect to
masks in the workplace, are necessary, and if such standards are
determined to be necessary, issue them by March 15, 2021'' (id.). OSHA
began working on the issue at once, and shortly after Secretary Walsh
took office on March 23, he ordered OSHA to ensure its analysis
addressed the latest information regarding the state of vaccinations
and virus variants (Rolfson and Rozen, April 6, 2021). In accordance
with the executive order and Secretary Walsh's directive, OSHA has
reviewed its May 2020 decision not to issue an ETS. For the reasons
explained below, OSHA does not believe its prior approach--enforcement
of existing standards and the General Duty Clause coupled with the
issuance of nonbinding guidance--has proven over time to be adequate to
``reduce the risk that workers may contract COVID-19'' in healthcare
settings. Given the grave danger presented by the hazard, OSHA now
finds that this standard is necessary to protect the healthcare
employees who face the highest risk of contracting COVID-19 at work.
See Nat'l Cable & Telecomm. Ass'n v. Brand X internet Svcs, 545 U.S.
967, 981 (2005) (noting that an agency must ``consider the wisdom of
its policy on a continuing basis . . . for example, in response to
changed factual circumstances, or a change in administrations'');
Asbestos Info. Ass'n, 727 F.2d at 423 (5th Cir. 1984) (``failure to act
does not conclusively establish that a situation is not an emergency .
. . [when there is a grave danger to workers,] to hold that because
OSHA did not act previously it cannot do so now only compounds the
consequences of the Agency's failure to act.'').
References
American Federation of Labor and Congress of Industrial
Organizations. (2020, March 6). ``To Address the Outbreak of COVID-
19: A Petition for an OSHA Emergency Temporary Standard for
Infectious Disease.'' (AFL-CIO, March 6, 2020).
American Federation of Labor and Congress of Industrial
Organizations. (2020, May 18). Emergency Petition For A Writ Of
Mandamus, and Request For Expedited Briefing And Disposition, No.
19-1158. (AFL-CIO, May 18, 2020).
American Federation of Labor and Congress of Industrial
Organizations, USCA Case #20-1158, Document #1846700. (2020, June
11). (AFL-CIO, June 11, 2020).
American Federation of Labor and Congress of Industrial
Organizations. Denial of Petition for Rehearing En Banc on Behalf Of
American Federation of Labor and Congress of Industrial
Organizations. USCA Case #20-1158, Document #1853761. (2020, July
28). (AFL-CIO, July 28, 2020).
American Federation of Teachers, et al., Petition For A Writ Of
Mandamus, No. 20-73203 (9th Cir., October 29, 2020). (2020, October
29). (AFT, October 29, 2020).
Carome, M. (2020, March 13). ``Letter requesting an immediate OSHA
emergency temporary standard for infectious disease.'' (Carome,
March 13, 2020).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
COVID data tracker.Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory: Trends in Total COVID-19
Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May 24, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
COVID data tracker.Trends in number of COVID-19 cases and deaths in
the US reported to CDC, by state/territory Daily Trends in Number of
COVID-19 Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases. (CDC, May
24, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
COVID data tracker. New Admissions of Patients with Confirmed COVID-
19, United States. https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions. (CDC, May 24, 2021c).
Centers for Disease Control and Prevention (CDC). (2020, May 28).
United States Coronavirus (COVID-19) Death Toll Surpasses 100,000.
https://www.cdc.gov/media/releases/2020/s0528-coronavirus-death-toll.html. (CDC, May 28, 2020).
DeVito, J. (2020, March 12). ``Grant OSHA emergency standard for
COVID-19 to protect frontline workers.'' (DeVito, March 12, 2020).
Murray, P, Brown, S, Heinrich, M, Brown, S, Blumenthal, R, Markey,
EJ, Van Hollen, C, Durbin, RJ, Smith, T, Whitehouse, S, Wyden, R,
King Jr., AS, Kaine, T, Reed, J, Menedez, R, Gillibrand, K,
Duckworth, T, Warren, E, Hassan, MW, Casey Jr., RP, Sanders, B,
Udall, T, Hirono, MK, Harris, KD, Feinstein, D, Klobuchar, A,
Booker, CA, Shaheen, J, Cardin, B. (2020, April 29). ``COVID-19 ETS
Petition.''(Murray et al., April 29, 2020).
National Nurses United (NNU). (2020, March 4). ``National Nurses
United Petitions OSHA for an Emergency Temporary Standard on
Emerging Infectious Diseases in Response to COVID-19.'' (NNU, March
4, 2020).
Occupational Safety and Health Administration (OSHA). (2020, March
18). Letter from Loren Sweatt to Congressman Robert C. ``Bobby''
Scott. (OSHA, March 18, 2020).
Occupational Safety and Health Administration (OSHA). (2020, May
29). Letter from Loren Sweatt to AFL-CIO President Richard Trumka.
(OSHA, May 29, 2020).
Owen, M. (2020, March 19). ``Grant OSHA emergency standard to
protect frontline workers from COVID-19.'' (Owen, March 19, 2020) .
ORCHSE Strategies. (2020, October 9). ``Petition to the U.S.
Department of Labor--Occupational Safety and Health Administration
(OSHA) for an Emergency Temporary Standard (ETS) for Infectious
Disease.'' (ORCHSE, October 9, 2020).
Pellerin, C. (2020). ``Grant OSHA emergency standard to protect
frontline workers from COVID-19.'' (Pellerin, March 19, 2020).
Public Citizen. (2020, March 13). ``Support for AFL-CIO's Petition
for an OSHA Emergency Temporary Standard for Infectious Disease to
Address the Epidemic of Novel Coronavirus Disease.'' (Public
Citizen, March 13, 2020).
Rolfson, B, Rozen, C. (2021, April 6). Labor Chief Walsh Puts Hold
on OSHA Virus Rule for More Analysis. Bloomberg Law. https://news.bloomberglaw.com/safety/labor-chief-walsh-puts-hold-on-osha-virus-rule-for-more-analysis. (Rolfson and Rozen, April 6, 2021).
Scott, RC and Adams, AS. (2020, January 30). ``Prioritize OSHA's
Work on Infectious Diseases Standard/Immediate Issue of Temporary
Standard.'' (Scott and Adams, January 30, 2020).
Solt, BE. (2020). ``COVID-19 ETS Petition.'' (Solt, April 28, 2020).
United States Department of Labor (DOL). (2020, May 29). In Re:
American Federation Of Labor And Congress Of Industrial
Organizations. Department Of Labor's Response to the Emergency
Petition for a Writ of Mandamus, No. 20-1158 (D.C. Cir., May 29,
2020). (DOL, May 29, 2020).
United States Department of Labor (DOL). (2020, December 31).
American Federation of Teachers, et al., Department of Labor's
Opposition to the Petition for a Writ of Mandamus, No. 20-73203 (9th
Cir., December 31, 2020). (DOL, December 31, 2020).
Wellington, M. (2020, March 12). ``Grant OSHA emergency standard for
COVID-19 to protect front-line workers''. (Wellington, March 12,
2020).
Yborra, G. (2020, March 19). ``Grant OSHA emergency standard to
protect frontline workers from COVID-19.'' (Yborra, March 19, 2020).
II. No Other Agency Action Is Adequate To Protect Employees Against
Grave Danger
For the first time in its 50-year history, OSHA faces a ``new
hazard'' so grave that it has killed almost 600,000 people in the
United States in barely over a year, and infected millions more. COVID-
19 can be spread to employees whenever an infected person exhales.
Those employees, once infected, could end up unable to breathe without
ventilators or suffer from failure of multiple body organs, and are at
risk of death or long-term debilitation. The COVID-19 pandemic has
taken a particularly heavy toll on workers in healthcare providing
frontline care to patients with suspected or confirmed COVID-19,
creating the precise situation that section 6(c)(1) of the OSH Act was
enacted to address. This ETS is necessary to protect these employees
from the grave danger posed by COVID-19.
When OSHA decided not to issue an ETS last spring, the agency had
preliminarily determined that sufficient employee protection against
COVID-19 could be provided through enforcement of existing workplace
standards and the General Duty Clause of the OSH Act, coupled with the
issuance of industry-specific, non-mandatory guidance. However, in
doing so OSHA indicated that its conclusion that an ETS was not
necessary was specific to the information available to the agency at
that time, and that the agency would continue to monitor the situation
and take additional steps as appropriate (see, e.g., OSHA, March 18,
2020, Letter to Congressman Scott (stating ``[W]e currently see no
additional benefit from an ETS in the current circumstances relating to
COVID-19. OSHA is continuing to monitor this quickly evolving situation
and will take the appropriate steps to protect workers from COVID-19 in
coordination with the overall U.S. government response effort.''
(emphasis supplied); DOL May 29, 2020 at 20 (stating ``OSHA has
determined this steep threshold [of necessity] is not met here, at
least not at this time.'' (emphasis supplied))). OSHA's subsequent
experience has shown that a new approach is needed to protect
healthcare workers from the grave danger posed by the COVID-19
pandemic.
At the outset, employers do not have a reliance interest in OSHA's
prior decision not to issue an ETS on May 29, 2020, which did not alter
the status quo or require employers to change their behavior. See Dep't
of Homeland Security v. Regents of the Univ. of
California, 140 S. Ct. 1891, 1913-14 (2020). As OSHA indicated when it
made the decision, the determination was based on the conditions and
information available to the agency at that time and was subject to
change as additional information indicated the need for an ETS. In
light of the agency's express qualifications and the surrounding
context, any employer reliance would have been unjustified and cannot
outweigh the countervailing urgent need to protect healthcare workers
from the grave danger posed by COVID-19.
Multiple developments support a change in approach. First, as noted
above, although the rates of death and hospitalization from COVID-19
have decreased in recent weeks as vaccines have become more widely
available, COVID-19 continues to pose a grave danger to healthcare
employees in settings where the risk of exposure to an infected person
is elevated because of the nature of the work performed. In addition,
some variability in infection rates in a pandemic is to be expected.
While the curves of new infections and deaths can bend down after
peaks, they often reverse course only to reach additional peaks in the
future (Moore et al., April 30, 2020). Several new mutations--or
variants--of the virus, preliminarily understood to be more contagious
than the original, are now spreading in this country.
Second, as discussed in more detail in Grave Danger (Section IV.A
of this preamble), while vaccines have been authorized for use for
several months, and the nationwide effort to fully vaccinate all
Americans is ongoing, more work is needed to build confidence among
Americans in the vaccines so that enough people are protected to bring
the virus under control, and to ensure that employees can get
vaccinated without the risk of losing their jobs or losing pay. The
standard is therefore necessary to facilitate vaccination among
healthcare workers by requiring employers to ``provid[e] reasonable
time and paid leave . . . to each employee for vaccination and any side
effects experienced following vaccination'' (paragraph (m)).
The standard also further encourages vaccination by fully exempting
``well-defined hospital ambulatory care settings where all employees
are fully vaccinated'' and all non-employees are screened and denied
entry if they are suspected or confirmed to have COVID-19 (paragraph
(a)(2)(iv)) and ``home healthcare settings where all employees are
fully vaccinated'' and all non-employees at that location are screened
prior to employee entry so that people with suspected or confirmed
COVID-19 are not present (paragraph (a)(2)(v)). In addition, the
standard encourages vaccination by exempting fully vaccinated employees
from the requirements for facemasks, physical distancing, and barriers
``in well-defined areas where there is no reasonable expectation that
any person with suspected or confirmed COVID-19 will be present''
(paragraph (a)(4)).
Further, OSHA's actual enforcement experience over the past year--
which had only just begun when OSHA announced its previous views on the
need for an ETS--has demonstrated that existing enforcement options do
not adequately protect healthcare employees from the grave danger posed
by COVID-19. As of May 23, 2021, OSHA and its State Plan partners have
received more than 67,000 COVID-related complaints since March of 2020
(OSHA, May 23, 2021). OSHA has received more complaints about
healthcare settings than any other industry.\14\ Although the number of
employee complaints has gone down in recent months since COVID-19
vaccines have become more widely available, OSHA continues to receive
hundreds of employee complaints every month, including many that
concern healthcare settings, asking for investigations of workplaces
where employees do not believe they are being adequately protected from
COVID-19 and indicating that their employers do not follow the guidance
issued by the agency and the CDC.
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\14\ As a result of these complaints, federal OSHA has conducted
2,305 inspections (State Plans have conducted 7,203 inspections) as
of May 23, 2021. On March 12, 2021, OSHA issued a National Emphasis
program to ensure that OSHA continues to devote a high percentage of
its inspection resources to COVID-19, with a target of roughly 1,600
inspections a year. These can be the result of complaints or
programmed inspections targeted at high hazard industries. However,
as described below, the effectiveness of the NEP will be hampered
without the ETS given the inadequacy of OSHA's current enforcement
tools.
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The following narratives are just a few recent examples of the
kinds of complaints OSHA continues to receive from healthcare employees
on a regular basis:
5/21/21 Doctor's office failed to remove employee with
COVID-19 symptoms.
5/21/21 Assisted living facility for the elderly failed to
notify employees that they were exposed to residents with COVID-19.
5/19/21 Doctor's office did not maintain distancing for
employees, did not notify employees of exposure to COVID-19, and did
not remove employees with COVID-19 symptoms from the workplace.
5/19/21 Doctor's office did not ensure that technician
wore gloves during COVID-19 treatment.
5/10/21 Clinic did not follow guidance for patient
screening or removal from the workplace of potentially infected
employee.
5/7/21 Psychiatric facility did not properly clean rooms
of COVID-19 positive patients, did not train employees to properly
remove infectious disease PPE when exiting COVID-19 positive areas to
other areas of the facility, and allows employees who have tested
positive for COVID-19 to continue to work at the workplace.
5/6/21 Hospital failed to promptly remove employee with
COVID-19 from the workplace, notify other employees of their exposure
to the COVID-19, and did not require employees to wear facemasks.
5/3/21 Doctor's office required employees to reuse
isolation gowns to an extent not consistent with CDC guidance.
This ETS addresses numerous issues raised in these complaints,
including physical distancing, PPE, cleaning and disinfection, and
measures to keep contagious co-workers away from the workplace.
Based on its thorough review of OSHA's existing approach to
protecting employees from COVID-19, OSHA finds that existing OSHA
standards, the General Duty Clause, and non-mandatory guidance issued
by OSHA are not adequate to protect healthcare employees from COVID-19.
Similarly, the numerous guidance products published by other entities,
such as CDC, are not sufficiently effective at protecting these
employees because such guidance is not enforceable and there is no
penalty for noncompliance. OSHA has determined that each of these
tools, as well any combination of them, is inadequate to address COVID-
related hazards in the settings covered by this standard, thereby
establishing the need for this ETS.
This inadequacy has also been reflected in the number of states and
localities that have issued their own mandatory standards in
recognition that existing measures (including non-mandatory guidance,
compliance assistance, and enforcement of existing standards) have
failed to adequately protect workers from COVID-19. While these state
and local requirements may have had positive effects where they have
been implemented, they are no replacement for a national standard that
would establish definitively that COVID-19 safety measures are no
longer
voluntary for the workers covered by this standard. Without a national
standard, the patchwork of inconsistent requirements has proven both
ineffective at a national level and burdensome to employers operating
across jurisdictions, increasing compliance costs and potentially
limiting the ability to implement protective measures at scale (See
ORCHSE, October 9, 2020). Congress has charged OSHA with protecting
America's workforce, and an ETS is the only measure capable of
providing adequate protection to the workers covered by this standard
from the grave danger posed by COVID-19.
a. The Current Standards and Regulations Are Inadequate
In updated enforcement guidance issued in March 2021 (OSHA, March
12, 2021), OSHA identified a number of current standards and
regulations that might apply when workers have occupational exposure to
SARS-CoV-2 (Interim Enforcement Response Plan) (OSHA, March 12,
2021).\15\ In addition to the standards listed there, OSHA has also
cited the Hazard communication standard (29 CFR 1910.1200) during
COVID-19 investigations. Accordingly, the complete list of potentially
applicable standards and regulations follows:
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\15\ The Interim Enforcement Response Plan also suggests that
while OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) does
not typically apply to respiratory secretions that may contain SARS-
CoV-2, the provisions of the standard offer a framework that may
help control some sources of the virus, including exposures to body
fluids (e.g., respiratory secretions) not covered by the standard.
While this is true for some of the controls required by that
standard, such as laundering and cleaning, it does not contain
requirements to implement necessary controls to protect employees
against airborne transmission of SARS-CoV-2, such as distancing,
barriers, and ventilation. And in any event, it imposes no
obligations unless blood or other potentially infectious materials
(as defined in the standard) are present.
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29 CFR part 1904, Recording and Reporting Occupational
Injuries and Illnesses. This regulation requires certain employers to
keep records of work-related fatalities, injuries, and illnesses and
report them to the government in specific circumstances.
29 CFR 1910.132, General requirements--Personal Protective
Equipment (PPE). This standard requires that appropriate PPE, including
PPE for eyes, face, head, and extremities, protective clothing,
respiratory devices, and protective shields and barriers, be provided,
used, and maintained in a sanitary and reliable condition.
29 CFR 1910.134, Respiratory protection. This standard
requires that employers provide, and ensure the use of, appropriate
respiratory protection when necessary to protect employee health.
29 CFR 1910.141, Sanitation. This standard applies to
permanent places of employment and contains, among other requirements,
general housekeeping and waste disposal requirements.
29 CFR 1910.145, Specification for accident prevention
signs and tags. This standard requires the use of biological hazard
signs and tags, in addition to other types of accident prevention signs
and tags.
29 CFR 1910.1020, Access to employee exposure and medical
records. This standard requires that employers provide employees and
their designated representatives access to relevant exposure and
medical records.
29 CFR 1910.1200, Hazard communication. This standard
requires employers to keep Safety Data Sheets (SDS) for chemical
hazards, provide SDSs to employees and their representatives when
requested, and train employees about those hazards. The standard does
not apply to biological hazards, but hazard communication becomes an
issue for the SARS-CoV-2 virus when chemicals are used to disinfect
surfaces. OSHA notes that, when such chemicals are used in the
workplace, the employer is required to comply with the hazard
communication standard. The agency has not incorporated hazard
communication requirements in the ETS, but has included related
training and notification requirements. Section 1910.1200 compliance is
only peripherally related to protection against SARS-CoV-2 hazards,
employers are generally aware of those requirements, and the
requirements of Sec. 1910.1200 are enforceable without being repeated
in the ETS.
Through its enforcement efforts to date, OSHA has encountered
significant obstacles demonstrating that existing standards and
regulations are inadequate to address the COVID-19 hazard for
healthcare workers, and has determined that a COVID-19 ETS is necessary
to address these inadequacies. As discussed in further detail below,
OSHA has determined that some of the above-listed standards--including
Sanitation at Sec. 1910.141--are in practice too difficult to apply to
the COVID-19 hazard and have never been cited in COVID enforcement;
other standards--such as Respiratory Protection at Sec. 1910.134 and
general PPE at Sec. 1910.132--are more clearly applicable to the
COVID-19 hazard, but for a variety of reasons have offered little
protection to the vast majority of employees who are not directly
caring for patients with suspected or confirmed COVID-19. Current CDC
guidance does not indicate that respirators are generally needed
outside of direct patient care, but CDC does support the protective
measures the ETS would require for the workers it covers (Howard, May
22, 2021).
Finally, the remaining listed standards and regulations--for
recordkeeping and reporting, accident prevention signs and tags, access
to employee records, and hazard communication--while applicable to the
COVID-19 hazard and important in the overall scheme of workplace
safety, do not require employers to implement specific measures to
protect workers from COVID-19. Further, as addressed in more detail
below, even applicable regulations like the reporting requirements did
not contemplate a hazard like COVID-19, and have proven to be difficult
to apply to it. Thus, for the reasons elaborated in further detail
below, OSHA has determined that its existing standards and regulations
are insufficient to adequately address the grave danger posed by COVID-
19 to healthcare workers.
First, most of the safety measures known to reduce the hazard of
COVID-19 transmission are not explicitly required by existing
standards: none expressly requires measures such as facilitating
vaccination, facemasks, physical distancing, physical barriers,
cleaning and disinfection (when appropriate), improved ventilation to
reduce virus transmission, isolation of sick employees, minimizing
exposures in the highest hazard settings such as aerosol-generating
procedures on patients with suspected or confirmed COVID-19, patient
screening and management, notification to employees potentially exposed
to people with COVID-19, or training on these requirements. For
example, although OSHA's existing Respiratory Protection and PPE
standards require respirators and PPE such as gloves and face shields
in some settings covered by the ETS, they do not require all of the
other layers of protection required by the ETS that are necessary to
mitigate the spread of COVID-19 in the workplace. See Need for Specific
Provisions (Section V of the preamble).
Similarly, while the Sanitation standard at Sec. 1910.141(a)(3)
requires places of employment ``to be kept clean to the extent that the
nature of the work allows,'' the standard does not require disinfection
of potentially contaminated surfaces nor does it speak to the level or
frequency with which cleaning is required to protect against an
infectious
disease hazard like COVID-19. Accordingly, OSHA has not yet identified
any instance in which the Sanitation standard could be applied in the
agency's COVID-19 enforcement efforts. Thus, OSHA's efforts to enforce
existing standards to address the COVID-19 hazard have been
significantly hindered by the absence of any specific requirements in
these standards related to some of the most important COVID-19-
mitigation measures. The COVID-19 ETS addresses this issue by clearly
mandating each of these necessary protections.
Second, because existing standards do not contain provisions
specifically targeted at the COVID-19 hazard, it may be difficult for
employers and employees to determine what particular COVID-19 safety
measures are required by existing standards, or how the separate
standards are expected to work together as applied to COVID-19. As
explained in more detail in the Need for Specific Provisions (Section V
of the preamble), the infection control practices required to address
COVID-19 are most effective when used together, layering their
protective impact. Because no such layered framework is currently
enforced nationally, the existing standards leave large gaps in
employee protection from COVID-19. An ETS with a national scope that
contains provisions specifically addressing the COVID-19 hazards facing
healthcare workers will provide clearer instructions to the average
employer than the piecemeal application of existing standards. The ETS
bundles all of the relevant requirements, providing a roadmap for
employers and employees to use when developing a plan and implementing
protections, so that employers and employees in the settings covered by
this standard know what is required to protect employees from COVID-19.
More certainty will lead to more compliance, and more compliance will
lead to improved protection of employees.
Third, requirements in some existing standards may be appropriate
for other situations but simply do not contemplate COVID-19 hazards.
For example, as noted above, the Sanitation standard at Sec. 1910.141
requires employers to provide warm water, soap, and towels that can be
used for hand washing, an important protective action against COVID-19,
and generally requires that places of employment be kept ``clean,'' but
it does not specify disinfection as a cleaning procedure, even though
disinfection is an important precaution against COVID-19 transmission.
Nor does it require the provision of hand sanitizer where hand washing
facilities cannot be made readily available. Similarly, existing
standards do not address facemasks for a hazard such as COVID-19, which
protect other workers (source control) as well as provide some degree
of protection to the wearer. The ETS, developed in direct response to
the COVID-19 hazard and associated pandemic, provides this needed
specificity so the employers covered by the ETS understand exactly what
is required during this unprecedented public health emergency.
Fourth, the existing recordkeeping and reporting regulations are
not adequate to help the employer or the agency assess the full scope
of COVID-19 workplace exposures. The recordkeeping regulations were not
written with the nature of COVID-19 transmission or illness in mind. In
order to adequately understand and thereby control the spread of COVID-
19 in the workplace, it is critical that the employer has a record of
all cases of COVID-19 occurring among employees; however, such
information is outside of the scope of OSHA's existing recordkeeping
requirements, which are limited to injuries or illnesses that the
employer knows to be work-related. The existing regulations are
premised on the assumption that employers can easily identify injuries
or illnesses that are work-related, but COVID-19 transmission can occur
in the workplace, the community, or the household, and it can be
difficult to identify the point of transmission. In numerous
investigations, OSHA has identified employee illnesses or deaths from
COVID-19 that were not reflected in the employer's required
recordkeeping logs because the employer was not able to determine
whether the illness or death was work-related. The COVID-19 log
required by the ETS will provide a fuller picture of the prevalence of
SARS-CoV-2 in the workplace by requiring employers to record employee
cases without a work-relatedness determination.
Furthermore, even where work-relatedness can be determined, the
existing reporting regulations are also inadequate in ensuring OSHA has
the full picture of the impact of COVID-19 in the settings covered by
this standard because the regulations only require employers to report
in-patient hospitalizations that occur within 24 hours of the work-
related incident and to report fatalities that occur within thirty days
of the work-related incident. But many COVID-19 infections will not
result in hospitalization or death until well after these limited
reporting periods; consequently they are not required to be reported to
OSHA, which limits the agency's ability to fully understand the impact
of COVID-19 on the workforce. In order to adequately understand and
thereby control the spread of COVID-19 in the workforce, it is critical
that the employer has a record of all cases of COVID-19 occurring among
employees and that OSHA is timely informed of all work-related COVID-19
in-patient hospitalizations and fatalities.
OSHA's existing recordkeeping and reporting requirements are also
inadequate for addressing the COVID-19 hazard in the workplaces covered
by the ETS because the current reporting structure does not require
employers to notify employees of possible exposures in the workplace.
While the recordkeeping requirements require employers to make illness
and injury records available to employees, 29 CFR 1910.35(b)(2), they
do not create an affirmative duty requiring employers to notify
employees when they may have been exposed to another employee with the
disease. Given the transmissibility of COVID-19, timely notification of
an exposure is critical to curbing further spread of COVID-19 and
protecting employees from the COVID-19 hazard.
Thus, OSHA's existing recordkeeping and reporting requirements are
not tailored to address hazards associated with COVID-19 in the
workplaces covered by the ETS. As a result, they do not enable OSHA,
employers, or employees to accurately identify and address such
hazards. The ETS addresses that issue by requiring employers to record
each instance identified by the employer in which an employee is COVID-
19 positive, regardless of whether the instance is connected to
exposure to COVID-19 at work; requiring employers to report work-
related, COVID-19 in-patient hospitalizations and fatalities,
regardless of when the exposure in the work environment occurred; and
imposing an affirmative duty requiring employers to notify employees of
COVID-19 exposure.
In conclusion, OSHA's experience has demonstrated that existing
standards alone are inadequate to address the COVID-19 hazard. The
limitations and inadequacies explained above prevent OSHA from
requiring all of the layers of controls necessary to protect employees
from COVID-19 under these existing standards, even in situations that
are clearly hazardous to employees. Thus, OSHA finds that its existing
standards are not sufficient to protect employees from the grave danger
posed by COVID-19.
b. The General Duty Clause Is Inadequate To Meet the Current Crisis
Section 5(a)(1) of the OSH Act, or the General Duty Clause,
provides the general mandate that each employer ``furnish to each of
[its] employees employment and a place of employment which are free
from recognized hazards that are causing or are likely to cause death
or serious physical harm to his employees.'' 29 U.S.C. 654(a)(1). While
OSHA has attempted to use the General Duty Clause to protect employees
from COVID-19-related hazards, OSHA has found that there are
significant challenges associated with this approach and therefore this
ETS is necessary to protect the workers covered by this standard from
the grave danger posed by COVID-19. While the General Duty Clause can
be used in many contexts, in OSHA's experience over the past year, the
clause falls short of the agency's mandate to protect employees from
the hazards of COVID-19 in the settings covered by the standard. As
explained more fully below, OSHA finds the ETS will more efficiently
and effectively address those hazards. Cf. Bloodborne Pathogens, 56 FR
64004, 64007, 64038 (Dec. 6, 1991) (bloodborne pathogens standard will
more efficiently reduce the risk of the hazard than can enforcement
under the general duty clause).
As an initial matter, the General Duty Clause does not provide
employers with specific requirements to follow or a roadmap for
implementing appropriate abatement measures. The ETS, however, provides
a clear statement of what OSHA expects employers to do to protect
workers, thus facilitating better compliance. The General Duty Clause
is so named because it imposes a general duty to keep the workplace
free of recognized serious hazards; the ETS, in contrast, lays out
clear requirements for COVID-19 plans, facemasks, distancing, barriers,
cleaning, personal protective equipment, and training, among other
things, and identifies the settings in which they are required.
Conveying obligations as clearly and specifically as possible provides
employers with enhanced notice of how to comply with their OSH Act
obligations to protect workers from COVID-19 hazards. See, e.g.,
Integra Health Mgmt., Inc., 2019 WL 1142920, at *7 n.10 (OSHRC No. 13-
1124, 2019) (noting that standards ``give clear notice of what is
required of the regulated community''); 56 FR 64007 (``because the
standard is much more specific than the current requirements [general
standards and the general duty clause], employers and employees are
given more guidance in carrying out the goal of reducing the risks of
occupational exposure to bloodborne pathogens'').
Moreover, several characteristics of General Duty Clause
enforcement actions limit how effectively OSHA can use the clause to
address hazards associated with COVID-19. Most important, the General
Duty Clause is not a good tool for requiring employers to adopt
specific, overlapping, and complementary abatement measures, like those
required by the ETS, and some important worker-protective elements of
the ETS (such as payment for medical removal) would be virtually
impossible for OSHA to require and enforce under the General Duty
Clause. Second, OSHA's burden of proof for establishing a General Duty
Clause violation is heavier than for standards violations.
Third, the ETS will enable OSHA to issue more meaningful penalties
for willful or egregious violations, thus facilitating better
enforcement and more effective deterrence against employers who
intentionally disregard their obligations under the Act or demonstrate
plain indifference to employee safety. Fourth, the General Duty Clause
does not provide complete protection to employees at multi-employer
worksites, which are common situations in hospitals, where more than
one employer controls hazards at the workplace. The ETS will permit
more thorough enforcement in these situations. Each of these is
discussed in more detail below.
General Duty Clause Citations Impose a Heavy Litigation Burden on OSHA
For contested General Duty Clause citations to be upheld, OSHA must
demonstrate elements of proof that are supplementary to, and can be
more difficult to show than, the elements of proof required for
violations of specific standards, where a hazard is presumed.
Specifically, to prove a violation of the General Duty Clause, OSHA
needs to establish--in each individual case--that: (1) An activity or
condition in the employer's workplace presented a hazard to an
employee; (2) the hazard was recognized; (3) the hazard was causing or
was likely to cause death or serious physical harm; and (4) feasible
means to eliminate or materially reduce the hazard existed. BHC Nw.
Psychiatric Hosp., LLC v. Sec'y of Labor, 951 F.3d 558, 563 (D.C. Cir.
2020).
For the first element of a General Duty Clause case, OSHA must
prove that there is a hazard, i.e., a workplace condition or practice
to which employees are exposed, creating the potential for death or
serious physical harm to employees. See SeaWorld of Florida LLC v.
Perez, 748 F.3d 1202, 1207 (D.C. Cir. 2014); Integra Health Management,
2019 WL 1142920, at *5. In the case of COVID-19, this means showing not
just that the virus is a hazard as a general matter--a fairly
indisputable point--but also that the specific conditions in the cited
workplace, such as performing administrative tasks in a waiting room
setting where patients are seeking treatment for suspected or confirmed
COVID-19, create a hazard. In contrast, an OSHA standard that requires
or prohibits specific conditions or practices establishes the existence
of a hazard. See Harry C. Crooker & Sons, Inc. v. Occupational Safety &
Health Rev. Comm'n, 537 F.3d 79, 85 (1st Cir. 2008); Bunge Corp. v.
Sec'y of Labor, 638 F.2d 831, 834 (5th Cir. 1981). Thus, in enforcement
proceedings under OSHA standards, as opposed to the General Duty
Clause, ``the Secretary need not prove that the violative conditions
are actually hazardous.'' Modern Drop Forge Co. v. Sec'y of Labor, 683
F.2d 1105, 1114 (7th Cir. 1982). With OSHA's finding that the hazard of
exposure to COVID-19 can exist in the workplaces covered by this
standard (see Grave Danger, above), the ETS will eliminate the burden
to repeatedly prove the existence of a COVID-19 hazard in each
individual case under the General Duty Clause.
One of the most significant advantages to standards like the ETS
that establish the existence of the hazard at the rulemaking stage is
that the Secretary can require specific abatement measures without
having to prove that the cited workplace is hazardous.\16\ In contrast,
under the General Duty Clause, the Secretary cannot require abatement
before proving in the enforcement proceeding that an existing condition
at the workplace is hazardous. For example, in a facial challenge to
OSHA's Grain Handling Standard, which was promulgated in part to
protect employees from the risk of fire and explosion from
accumulations of grain dust, the Fifth Circuit acknowledged OSHA's
inability to effectively protect employees from these hazards under the
General Duty Clause in upholding, in large part, the standard.
See Nat'l Grain & Feed Ass'n v. Occupational Safety & Health Admin.,
866 F.2d 717, 721 (5th Cir. 1988) (noting Secretary's difficulty in
proving explosion hazards of grain handling under General Duty Clause).
Although OSHA had attempted to address fire and explosion hazards in
the grain handling industry under the General Duty Clause, ``employers
generally were successful in arguing that OSHA had not proved that the
specific condition cited could cause a fire or explosion.'' Id. at 721
& n.6 (citing cases holding that OSHA failed to establish a fire or
explosion hazard under the General Duty Clause). In other words, the
General Duty Clause was not an effective tool because OSHA could not
prove that existing conditions at the cited workplace were hazardous.
The Grain Handling Standard, in contrast, established specific limits
on accumulations of grain dust based on its combustible and explosive
nature, and the standard allowed OSHA to cite employers for exceeding
those limits without the need to prove at the enforcement stage that
each cited accumulation was likely to cause a fire or explosion. See
id. at 725-26. The same logic applies to COVID-19 hazards. Given OSHA's
burden under the General Duty Clause to prove that conditions at the
cited workplace are hazardous, it is difficult for OSHA to ensure
necessary abatement before employee lives and health are unnecessarily
endangered by exposure to COVID-19. The ETS, on the other hand, allows
OSHA to cite employers for each protective requirement they fail to
implement without the need to prove in an enforcement proceeding that
the particular cited workplace was hazardous at the time of citation
without that particular measure in place.
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\16\ ``The Act does not wait for an employee to die or become
injured. It authorizes the promulgation of health and safety
standards and the issuance of citations in the hope that these will
act to prevent deaths and injuries from ever occurring.'' Whirlpool
Corp, v. Marshall, 445 U.S. 1, 12 (1980); see also Arkansas-Best
Freight Sys., Inc. v. Occupational Safety & Health Rev. Comm'n, 529
F.2d 649, 653 (8th Cir. 1976) (noting that the ``[OSH] Act is
intended to prevent the first injury'').
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An additional limitation of the General Duty Clause is that it
requires OSHA to show that there was a feasible and effective means of
abating the hazard. To satisfy this element, OSHA is required to prove
that there are abatement measures that will be effective in materially
reducing the hazard. See Integra Health Management, 2019 WL 1142920, at
*12. Proving the existence of feasible abatement measures that will be
effective in materially reducing the hazard usually requires testimony
from an expert witness, which limits OSHA's ability to prosecute these
cases as broadly as needed to protect more workers. See, e.g., id. at
*13 (requiring expert witness to prove proposed abatement measures
would materially reduce hazard). In contrast, where an OSHA standard
specifies the means of compliance, the agency has already made the
necessary technical determinations in the rulemaking and therefore does
not need to establish feasibility of compliance as part of its prima
facie case in an enforcement proceeding; instead, the employer bears
the burden of proving infeasibility as an affirmative defense. See,
e.g., A.J. McNulty & Co. v. Sec'y of Labor, 283 F.3d 328, 334 (D.C.
Cir. 2002); S. Colorado Prestress Co. v. Occupational Safety & Health
Rev. Comm'n, 586 F.2d 1342, 1351 (10th Cir. 1978). Protecting as many
workers as quickly as possible is especially critical in the context of
COVID-19 because, as explained in Section IV.A, Grave Danger, it can
spread so easily in the workplaces covered by this ETS.
The General Duty Clause Is Ill-Suited to Requiring Employers To Adopt a
Comprehensive Set of Complementary Abatement Measures, Like Those
Required by the ETS
As explained in Section V. Need for the Specific Provisions of the
ETS, effective infection control programs use a suite of overlapping
controls in a layered approach to ensure that no inherent weakness in
any one approach results in an infection incident. Each of the
practices required by the ETS provides some protection from COVID-19 on
its own, but the practices must be used together to ensure adequate
worker protection. However, General Duty Clause enforcement poses key
obstacles that prevent OSHA from requiring the types of overlapping
controls necessary to address COVID-19 hazards. Because the General
Duty Clause requires OSHA to establish the existence and feasibility of
abatement measures that can materially reduce a hazard, it can be
difficult for OSHA to use 5(a)(1) to require a full suite of
overlapping or complementary control measures, or, in other words, to
require additional abatement measures in situations where an employer
is doing something, but not everything the ETS will require, to address
COVID-19 hazards.
In many cases over the past year where OSHA investigated COVID-19-
related complaints, the agency discovered that employers were following
some minimal mitigation strategy while ignoring other crucial
components of employee protection. In such instances, because the
employer had taken some steps to protect workers, successfully proving
a General Duty Clause citation would have required OSHA to show that
additional missing measures would have further materially reduced the
COVID-19 hazard. Although OSHA believes each measure required by this
ETS materially reduces the COVID-19 hazard, there are key challenges
inherent in trying to make such a showing in an individual case, such
as the difficulty of pinpointing exactly when and how employees could
become infected with COVID-19 and establishing the magnitude of the
effect particular abatement measures would have on reducing infection
in the specific conditions present in the employer's workplace. See,
e.g., Pepperidge Farm, Inc., 17 OSH Cas. (BNA) 1993, 1997 WL 212599, at
*51 (OSHRC No. 89-265, Apr. 26, 1997) (finding that additional feasible
abatement measure established by the Secretary to address ergonomic
hazard did not materially reduce the hazard in light of the other steps
the employer had taken). The ETS cures this problem by imposing
separate requirements for, and establishing the general effectiveness
of, each necessary mitigation measure, thereby ensuring employers have
an enforceable obligation to provide the full suite of workplace
protections recommended by the CDC and other expert bodies.
Consider a hospital setting where patients with suspected or
confirmed COVID-19 receive treatment. The employer requires respirators
for employees providing direct care to those patients but little else
to protect those employees or other workers in those settings who are
not directly involved in patient care. Under the ETS, OSHA can cite the
employer for violating the specific requirements necessary to protect
all workers in those settings, such as facemasks for workers who are
not directly caring for patients, physical distancing or barriers
between administrative employees and patients who have not yet been
screened for suspected or confirmed COVID-19, work practice controls
for employees performing aerosol-generating procedures on people with
suspected or confirmed COVID-19, patient screening and management, paid
leave for vaccination, and medical removal protection.
Without the ETS, however, OSHA would have to cite the employer
under the General Duty Clause for the much broader violation of failing
to eliminate the recognized workplace hazard of COVID-19 infection.
This would require OSHA to prove: (1) That the hazard of COVID-19
infection was present and recognized for employees at this particular
healthcare workplace, and (2) that additional abatement methods would
materially reduce the hazard, over and above the reduction achieved by
the use of respirators as already required under 29 CFR 1910.134 for
exposure to people with suspected or confirmed COVID-19. Both of these
elements would likely require expert witness testimony specific to
conditions in this particular workplace, and it may be difficult to
establish that each layer of protection necessary to comprehensively
protect employees would have materially reduced the hazard depending on
the facts of the specific instance.
Further, even where OSHA establishes a violation of the General
Duty Clause, the employer is under no obligation to implement the
precise feasible means of abatement proven by OSHA as part of its prima
facie case. Cyrus Mines Corp., 11 OSH Cas. (BNA) 1063, 1982 WL 22717,
at *4 (OSHRC No. 76-616, Dec. 17, 1983). Thus, even in cases where OSHA
prevails, the employer need not necessarily implement the specific
abatement measure(s) OSHA established would materially reduce the
hazard. The employer could select alternative controls and then it
would be up to OSHA, if it wished to cite the employer again, to
establish that the recognized hazard continued to exist and that adding
physical distancing or barriers, for example, could materially reduce
the hazard even further.
Finally, there are some crucial requirements in the ETS that OSHA
would have difficulty enforcing under the General Duty Clause. Of
particular note, OSHA is adopting provisions in the ETS that require
paid time for vaccination and recovery from vaccine side effects, and
removal of COVID-19-positive employees and other workers exposed to
them from the workplace and payment of salary for employees who are
removed (medical removal protection, or ``MRP''). These provisions are
critical to protecting workers because they facilitate vaccination,
which is the preferred means of protecting workers exposed to COVID-19
hazards, and removal of infected employees and their close contacts as
soon as the employer knows they have COVID-19. Additional discussion of
the importance of these provisions can be found in Section V. Need for
the Specific Provisions of the ETS. While it might be possible for OSHA
to establish the value of vaccination as a protective measure and the
need to remove known infected employees in a General Duty Clause case,
it is highly unlikely that OSHA could require payment to those
employees, or other measures to encourage employees to get vaccinated
or to let their employers know when they test positive for COVID-19.
Rather, paid leave for vaccination and MRP are measures better
implemented through OSHA's statutory authority to promulgate standards.
Standards are forward-looking and can be used to create a comprehensive
network of required, and in this case of layered, worker safety
protections. The ETS creates just such a network, and vaccination and
MRP are important layers of that approach.
The ETS Will Permit OSHA To Achieve Meaningful Deterrence When
Necessary To Address Willful or Egregious Failures To Protect Employees
Against the COVID-19 Hazard
As described above, in contrast to the broad language of the
General Duty Clause, the ETS will clarify what exactly employers are
required to do to protect employees from COVID-19-related hazards,
making it easier for OSHA to determine whether an employer has
intentionally disregarded its obligations or exhibited a plain
indifference to employee safety or health. In such instances, OSHA can
classify the citations as ``willful,'' allowing it to propose higher
penalties, with increased deterrent effects. Early in the pandemic,
shifting guidance on the safety measures employers should take to
protect their employees from COVID-19 created ambiguity regarding
employers' specific obligations. Thus, OSHA could not readily determine
whether a particular employer had ``intentionally'' disregarded
obligations that were not yet clear. And, even as the guidance began to
stabilize, OSHA's ability to determine ``intentional disregard'' or
``plain indifference'' was difficult, for example, when an employer
took some, but not all, of the necessary steps to sufficiently address
the COVID-19 hazard. Given the current understanding that multiple
layers of protection are necessary to adequately protect workers from
COVID-19, an ETS will ensure that employers have clearer notice of
their obligations. This will allow the agency to take appropriate steps
to redress the situation where an employer has intentionally
disregarded the requirements necessary to protect employees from the
COVID-19 hazard, or has acted with plain indifference to employee
safety.
Further, OSHA has adopted its ``egregious'' policy to impose
sufficiently large penalties to achieve appropriate deterrence against
bad actor employers who willfully disregard their obligation to protect
their employees when certain aggravating circumstances are present,
such as a large number of injuries or illnesses, bad faith, or an
extensive history of noncompliance. (OSHA Directive CPL 02-00-080
(October 21, 1990.)) Its purpose is to increase the impact of OSHA's
enforcement ability. This policy uses OSHA's authority to issue a
separate penalty for each instance of willful noncompliance with an
OSHA standard, such as each employee lacking the same required
protections, or each workstation lacking the same required controls. It
can be more difficult to use this policy under the General Duty Clause
because the Fifth Circuit and the Occupational Safety and Health Review
Commission have held that OSHA may only cite a hazardous condition once
under the General Duty Clause, regardless of its scope. Reich v.
Arcadian Corp., 110 F.3d 1192, 1199 (5th Cir. 1997). Thus, even where
OSHA finds that an employer willfully failed to protect a large number
of employees from a COVID-19 hazard, OSHA likely could not cite the
employer on a per-instance basis for failing to protect each of its
employees. A COVID-19-specific ETS will clarify the permissible units
of prosecution and thereby make clear OSHA's authority to separately
cite employers for each instance of the employer's failure to protect
employees and for each affected employee, where appropriate.
By providing needed clarity, the ETS will facilitate ``willful''
and ``egregious'' determinations that are critical enforcement tools
OSHA can use to adequately address violations by employers who have
shown a conscious disregard for the health and safety of their workers
in response to the pandemic. Without the necessary clarity, OSHA has
been limited in its ability to impose penalties high enough to motivate
the very large employers who are unlikely to be deterred by penalty
assessments of tens of thousands of dollars, but whose noncompliance
can endanger thousands of workers. Without a willful classification (or
a substantially similar prior violation), the maximum penalty for a
serious General Duty Clause violation is $13,653, regardless of the
scope of the hazard.
The General Duty Clause Provides Incomplete Protection at Multi-
Employer Worksites
Finally, the General Duty Clause has limited application to multi-
employer worksites like hospitals, as it cannot be used to cite an
employer whose own employees were not exposed to a hazard even if that
employer may have created, contributed to, or controlled the hazard.
See Solis v. Summit Contractors, Inc., 558 F.3d 815, 818 (8th Cir.
2009) (``Subsection (a)(1) [the General Duty Clause] creates a general
duty running only to an employer's own employees,
while subsection (a)(2) creates a specific duty to comply with
standards for the good of all employees on a multi-employer
worksite.''). For example, if a janitorial services contractor were to
send one employee who is COVID-19 positive into a healthcare setting
and knowingly allow that employee to work around employees of other
employers, the janitorial services contractor who created the hazard
could not be issued a General Duty Clause citation because none of that
employer's own employees would have been exposed to the hazard. This
limitation of the General Duty Clause can prevent OSHA from citing the
employer on a multi-employer worksite who may be the most responsible
for an existing COVID-19 hazard or best positioned to mitigate that
hazard.
For all of the reasons described above, OSHA finds that the General
Duty Clause is not an adequate enforcement tool to protect the
employees covered by this standard from the grave danger posed by
COVID-19.
c. OSHA and Other Entity Guidance Is Insufficient
OSHA has issued numerous non-mandatory guidance products to advise
employers on how to protect workers from SARS-CoV-2 infection. (See
https://www.osha.gov/coronavirus) Even the most comprehensive guidance
makes clear, as it must, that the guidance itself imposes no new legal
obligations, and that its recommendations are ``advisory in nature.''
(See OSHA's online guidance, Protecting Workers: Guidance on Mitigating
and Preventing the Spread of COVID-19 in the Workplace (January 29,
2021); and OSHA's earlier 35-page booklet, Guidance on Preparing
Workplaces for Covid-19 (March 9, 2020)). This guidance, as well as
guidance materials issued by other government agencies and
organizations, including the CDC, the Centers for Medicare & Medicaid
Services (CMS), the Institute of Medicine (IOM), and the World Health
Organization (WHO), help protect employees to the extent that employers
voluntarily choose to implement the practices they recommend.\17\
Unfortunately, OSHA's experience shows that does not happen
consistently or rigorously enough, resulting in inadequate protection
for employees.
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\17\ Although the Centers for Medicare & Medicaid Services (CMS)
has issued regulations requiring healthcare employers that accept
payment through Medicare and Medicaid to implement nationally
recognized infection control practices (see 42 CFR Pts. 400-699),
those regulations do not obviate the need for this ETS. As a
preliminary matter, not all healthcare workplaces covered by the ETS
accept Medicare and Medicaid, and those that do not are not required
to comply with the CMS regulations. Furthermore, OSHA has important
enforcement tools that CMS lacks: OSHA can enforce a standard by
responding to complaints, conducting random unannounced inspections,
and issuing citations with penalties, whereas compliance with CMS
regulations is generally validated through periodic accreditation
surveys. The joint effect of the CMS regulations and a new ETS would
improve the breadth, quality and implementation of infection control
programs in a manner that the CMS regulations cannot do, and have
not done, alone. Indeed, that has been OSHA's experience in
enforcing its existing standards against healthcare employers that
overlap with CMS requirements, such as the Respirator, PPE, and
Bloodborne Pathogens standards. Thus, the ETS is necessary to
provide additional coverage and enforcement tools above and beyond
the CMS regulations.
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As documented in numerous peer-reviewed scientific publications,
CDC, IOM, and WHO have recognized a lack of compliance with non-
mandatory recommended infection-control practices (Siegel et al., 2007;
IOM, 2009; WHO, 2009). OSHA was aware of these findings when it
previously concluded that an ETS was not necessary, but at the time of
that conclusion, the agency erroneously believed that it would be able
to effectively use the non-mandatory guidance as a basis for
establishing the mandatory requirements of the General Duty Clause, and
informing employers of their compliance obligations under existing
standards. As explained above, that has not proven to be an effective
strategy. Moreover, when OSHA made its initial necessity determination
at the beginning of the pandemic, it made an assumption that given the
unprecedented nature of the COVID-19 pandemic, there would be an
unusual level of widespread voluntary compliance by the regulated
community with COVID-19-related safety guidelines (see, e.g., DOL, May
29, 2020 at 20 (observing that ``[n]ever in the last century have the
American people been as mindful, wary, and cautious about a health risk
as they are now with respect to COVID-19,'' and that many ``protective
measures are being implemented voluntarily, as reflected in a plethora
of industry guidelines, company-specific plans, and other sources'')).
Since that time, however, developments have led OSHA to conclude
that the same uneven compliance documented by CDC, IOM, and WHO is also
occurring for the COVID-19 guidance issued by OSHA and other agencies.
This was evidenced by a cross-sectional study performed from late
summer to early fall of 2020 in New York and New Jersey that found non-
compliance and widespread inconsistencies in COVID-19 response programs
(Koshy et al., February 4, 2021). Several other factors have also been
found to contribute to uneven implementation of controls to prevent the
spread of COVID-19. For example, there has been a reported rise of
``COVID fatigue'' or ``pandemic fatigue''--i.e., a decrease in
voluntary use of COVID-19 mitigation measures over time (Silva and
Martin, November 14, 2020; Meichtry et al., October 26, 2020; Belanger
and Leander, December 9, 2020). In addition, the fear of financial
loss; skepticism about the danger posed by COVID-19; and even a simple
human tendency, called ``psychological reactance,'' to resist curbs on
personal freedoms, i.e., an urge to do the opposite of what somebody
tells you to do, may also play a role in the uneven implementation of
COVID-19 mitigation measures (Belanger and Leander, December 9, 2020;
Markman, April 20, 2020).
The high number of COVID-19-related complaints and reports also
suggests a lack of widespread compliance with existing voluntary
guidance. Although the number of employee complaints is declining, OSHA
continues to receive hundreds of complaints every month, including
complaints alleging that healthcare employers are not consistently
following non-mandatory CDC guidance to protect employees. If guidance
were followed more strictly, or if there were enough voluntary
compliance with steps to prevent illness, OSHA would expect to see a
significant reduction in COVID-19-related complaints from employees.
The dramatic increases in the percentage of the population that
contracted the virus toward the end of 2020 and in early 2021 indicated
a continued risk of COVID-19 spread in workplace settings (for more
information on the prevalence of COVID-19 see Grave Danger (Section
IV.A of the preamble)) despite OSHA's publication of numerous specific
and comprehensive guidance documents. OSHA has found that neither
reliance on voluntary action by employers nor OSHA non-mandatory
guidance is an adequate substitute for specific, mandatory workplace
standards at the federal level. Public Citizen v. Auchter, 702 F.2d
1150 at 1153 (voluntary action by employers ``alerted and responsive''
to new health data is not an adequate substitute for government
action). The ETS is one aspect of the national response to the pandemic
that is needed to improve compliance with infection control measures by
establishing clear, enforceable measures that put covered employers on
notice that they must,
rather than should, take action to protect their employees. For these
reasons, OSHA finds that non-mandatory guidance efforts are not
sufficient, by themselves or in conjunction with General Duty Clause
enforcement, to protect employees covered by this ETS from being
infected by, and suffering death or serious health consequences from,
COVID-19.
d. A Uniform Nationwide Response to the Pandemic Is Necessary To
Protect Workers
OSHA is charged by Congress with protecting the health and safety
of American workers. Yet OSHA's previous approach proved ineffective in
meeting that charge. While some states and localities stepped in to
fill the gaps in employee protection, these approaches do not provide
consistent protection to workers and have, in some cases, been relaxed
prematurely, leading to additional outbreaks (Hatef et al., April
2021). In some states there are no workplace requirements at all. OSHA
has determined that a Federal standard is needed to ensure sufficient
protection for employees in all states in the settings covered by this
ETS; clarity and consistency about the obligations employers have to
protect their employees in these settings; and a level playing field
among employers.
As the pandemic has continued in the United States, there has been
increasing recognition of the need for a more consistent national
approach (GAO, September 2020; Budryk, November 17, 2020; Horsley, May
1, 2020). One of the justifications for OSHA standards has always been
to ``level the playing field'' so that employers who proactively
protect their workforces are not placed at a competitive disadvantage
(Am. Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 521 n.38 (1981)).
Many employers have advised OSHA that they would welcome a nationwide
ETS for that reason. For example, in its October 9, 2020 petition for a
COVID-19 ETS, ORCHSE Strategies, LLC explained that it is
``imperative'' that OSHA issue an ETS to provide employers one
standardized set of requirements to address safety and health for their
workers (ORCHSE, October 9, 2020). This group of prominent business
representatives explained that an ETS would eliminate confusion and
unnecessary burden on workplaces that are struggling to understand how
best to protect their employees in the face of confusing and differing
requirements across states and localities. While noting that ``OSHA
could not pre-empt a State from keeping its own rule (assuming it is
`at least as effective' as OSHA's standard),'' they also observed that
``historically, the impact of federal rulemaking in similar situations
(e.g., HazCom) has been that most, if not all, of the States ultimately
adhere to the federal requirements . . . . That can only be
accomplished if OSHA takes the lead'' (id.). ``Without an ETS,'' they
continue, ``employers are left on their own to determine the preventive
measures that need to be undertaken'' (id.).
Given that thousands of healthcare employees each week continue to
be infected with COVID-19, many of whom will become hospitalized or
die, OSHA recognizes that a patchwork approach to worker safety has not
been successful in mitigating this infectious disease outbreak, and
that an ETS is necessary to provide clear and consistent protection to
covered employees across the country.
e. OSHA's Other Previous Rationales for Not Promulgating an ETS No
Longer Apply
In addition to asserting that existing standards, guidance, and the
General Duty Clause would provide sufficient tools to address COVID-19
hazards to employees, OSHA had previously cited the need to respond to
evolving scientific knowledge about the virus as part of its rationale
for not issuing an ETS during the late spring of 2020. Knowledge of the
nature of COVID-19 was undoubtedly less certain at the beginning of the
pandemic when OSHA made its initial determination that an ETS was not
necessary. There have been recent changes in CDC recommendations for
vaccinated people outside the healthcare context. However, for
unvaccinated workers, since the summer of 2020 there has been
considerable stability in the guidance from the CDC and other health
organizations regarding the basic precautions that are essential to
protect unvaccinated people from exposure to COVID-19 while indoors.
And the CDC still recommends these precautions to protect vaccinated
workers in healthcare settings. For example, the CDC's COVID-19
guidance on How to Protect Yourself & Others (CDC, March 8, 2021)
includes the same guidance it issued in July 2020 regarding the basic
protections of face coverings, distancing, barriers, and hand hygiene.
Moreover, OSHA's previous concern--that an ETS would unintentionally
enshrine requirements that are subsequently proven ineffective in
reducing transmission--has proven to be overstated. Moreover, even
after issuing an ETS OSHA retains the flexibility to update the ETS to
adjust to the subsequent evolution of CDC workplace guidance. The major
development in infection control over the last year--the development,
authorization, and growing distribution and use of COVID-19 vaccines--
is addressed in the ETS. Going forward, further developments can be
addressed through OSHA's authority to modify the ETS if needed, or to
withdraw it entirely if vaccination and other efforts end the current
emergency. Nothing in the D.C. Circuit's decision in In re Am. Fed'n of
Labor & Cong. of Indus. Orgs., No. 20-1158, 2020 WL 3125324 (AFL-CIO,
June 11, 2020); rehearing en banc denied (July 28, 2020) precludes
OSHA's decision to promulgate an ETS now. To the contrary, at an early
phase of the pandemic, when its most severe effects had not yet been
experienced, the court decided not to second-guess OSHA's decision to
hold off on regulation in order to see if its non-regulatory
enforcement tools could be used to provide adequate protection against
the virus. ``OSHA's decision not to issue an ETS is entitled to
considerable deference,'' the court explained, noting the ``the
unprecedented nature of the COVID-19 pandemic'' and concluding merely
that ``OSHA reasonably determined that an ETS is not necessary at this
time.'' (Id., with emphasis added).
Finally, it is worth noting that OSHA's conclusion as to the
ineffectiveness of the current approach--i.e., relying on existing
enforcement tools and voluntary guidance--is supported by a report
issued by the DOL Office of Inspector General, dated February 25, 2021,
which concluded after an investigation that OSHA's prior approach to
addressing the hazards of COVID-19 leaves employees across the country
at increased risk of COVID-19 infection (DOL OIG, February 25, 2021).
The DOL OIG report specifically recommended that OSHA reconsider its
prior decision not to issue an ETS to provide the necessary protection
to employees from the hazards of COVID-19.
f. Even in Combination, the Guidance and General Duty Clause Are Still
Inadequate
Early in the pandemic, OSHA took the position that existing
standards, together with the combination of non-mandatory guidance and
General Duty Clause citations, would be sufficient to protect employees
so that specific mandatory requirements would not be necessary. In
theory, where existing standards did not address an issue directly, the
remaining regulatory gap could be filled by guidance from OSHA,
which would provide notice of COVID-19 hazards and describe feasible
means of abating them, enabling OSHA to later issue a General Duty
Clause citation to an employer who had failed to follow that guidance.
OSHA's enforcement experience has now disproven that theory. As
explained above, existing standards leave an enormous regulatory gap
that OSHA's guidance, together with the General Duty Clause, cannot
cover for the settings covered by this ETS.
In practice, the combination of guidance and General Duty Clause
authority has done little to protect employees in settings covered by
the standard where employers were not focused on that goal. The
limitations identified above, including the heavy litigation burden for
General Duty Clause citations, remain. Instead of being able to rely on
clear requirements in a standard, employers were left to wade through
guidance not only from OSHA but also from multiple other agencies,
states, media, and other sources without any clarity as to how the
different guidance materials should work together or what to do when
alternative guidance did not square with OSHA's guidance. Perhaps
because OSHA's guidance was not mandatory, it was frequently ignored or
followed only in part. As explained above, the General Duty Clause's
shortcomings as an enforcement tool left OSHA, in most cases,
ultimately unable to impose all of the layers of protection necessary
to protect employees from COVID-19.
In sum, based on its enforcement experience during the pandemic to
date, OSHA concludes that continued reliance on existing standards,
together with the combination of guidance and General Duty Clause
obligations, in lieu of an ETS, will not protect employees covered by
this ETS against the grave danger posed by COVID-19.
g. Recent Vaccine Developments Demonstrate the Importance of the ETS;
They Do Not Obviate the Current Need for an ETS
The development and availability of safe and highly effective
vaccines is an important development in the nation's response to COVID-
19. The very low percentage of breakthrough cases (illness among
vaccinated people) have led to recent updates to CDC guidance
acknowledging vaccination as an effective control to prevent
hospitalization and death from COVID-19 to such an extent that the CDC
has concluded that most other controls are not necessary to protect
vaccinated people outside healthcare settings. In the United States,
all people ages 12 and older are eligible to be vaccinated, and
vaccines are readily available in most parts of the country.
However, despite the remarkable success of our nation's vaccine
program and the substantial promise that vaccines hold, as explained
below, OSHA does not believe they eliminate the need for this standard.
OSHA embraces the value of vaccination and views the ETS as essential
to facilitating access to this critical control for those workers who
wish to receive it while still protecting those who cannot be, or will
not be, vaccinated. And by excluding certain workplaces and well-
defined work areas where all employees are fully vaccinated from all
requirements of the standard (paragraphs (a)(2)(iv) and (v)), and
exempting fully vaccinated workers in certain settings where not all
employees are vaccinated from several requirements of the standard
(paragraph (a)(4)), the ETS encourages vaccination for employers and
employees who do not want to follow those requirements.
In addition, for vaccines to be effective, workers need first to
actually receive them. While the supply of vaccines and their
distribution continues to increase, as of the date of the promulgation
of this standard, approximately a quarter of healthcare workers have
not yet completed COVID-19 vaccination with many of those expressing
vaccine hesitation (King et al., April 24, 2021). Although a majority
of Americans over 65 are vaccinated, the percentage among the working-
age population is much lower (44%) (CDC, May 24, 2021a). There are
several barriers to vaccination for the working-age population. Many
employees who want to be vaccinated may be unable to do so unless the
employer authorizes time off work, or may be financially unable to
absorb a reduced paycheck for taking unpaid leave to be vaccinated or
potentially missing a significantly larger period of time from work
(and a larger financial hit) because of the potential side effects of
the vaccination (SEIU Healthcare, February 8, 2021). A recent Kaiser
Foundation survey of people who expressed reluctance to be vaccinated
indicates that 70% of those respondents (76% and 77% among Black and
Latinx respondents, respectively) were concerned about side effects,
and 45% (57% Black and 54% Latinx) cited fears that they might miss
work if the side effects made them sick (KFF, May 6, 2021). Another
recent study, which surveyed 500 businesses, found that paid time off
for vaccination and recovery was the highest overall motivator for
employees to get vaccinated (51%), which was even higher than employers
offering the vaccine on site (49%) (Azimi et al., April 9, 2021). Yet a
different report indicates that before the pandemic, about 70% of the
lowest-wage workers had no access to paid sick leave, meaning that any
time off for vaccination or recovery would result in lost wages for
those who can least afford those losses (Gould, February 28, 2020).
Despite the American Rescue Plan (ARP) extending tax credits for some
employers to allow this sort of sick leave, such leave is not mandated.
Those surveys are consistent with the experience among healthcare
workers at Yale University and Yale New Haven Hospital. When workers
were surveyed at the time the FDA granted Emergency Use Authorization
of the Pfizer-BioNTech vaccine, the lack of incentives or mitigation of
risk (e.g., not using sick days or pay loss for side effects) was a key
reason stated by people who identified themselves as unlikely to get
the vaccine. (Roy et al., December 29, 2020). Following four months of
vaccination efforts, researchers found that although 75% had been
vaccinated, roughly half of low wage, hourly employees, had not yet
been vaccinated, and based on their previous research, identified the
provision of additional paid sick leave days as a critical barrier for
this population of workers (Roy and Forman, April 7, 2021). Even when
employees can arrange for time off for the first dose, some of the same
difficulties may prevent workers from returning during the designated
time window for the second dose of two-dose vaccines. The ETS addresses
these obstacles with a requirement that employers must authorize paid
leave to cover the time for vaccination and for recovery from side
effects.
Further, there is a need to continue building vaccine confidence in
some parts of the population, making the ETS even more important to
assure safe working conditions during the period before these workers
are vaccinated. Moreover, as discussed in more depth in Grave Danger
(Section IV.A. of the preamble), even though vaccines are now more
readily available, they do not protect all workers. Some workers are
unable to be vaccinated for medical or other reasons, even if they are
willing to be. And in immunocompromised workers, vaccines can be
considerably less effective than in immunocompetent individuals.\18\
And while some
employees may simply elect not to be vaccinated for personal reasons,
OSHA has a statutory duty to ensure that employers protect those
employees from the grave danger of COVID-19 regardless of their basis
for refusing vaccination.
---------------------------------------------------------------------------
\18\ There is concern that vaccines may not be effective for
immunocompromised individuals. A study evaluating 67 individuals
with blood cancers found that 46% of them did not generate an immune
response despite being fully vaccinated (Agha et al., April 7,
2021). Almost three quarters of those with chronic lymphocytic
leukemia were non-responsive. A study on 658 transplant recipients
found that 46% of recipients did not develop an immune response,
including 18% of those not on an immunosuppression regimen and 33%
of those who received their transplant more than 12 years prior
(Boyarsky et al., May 5, 2021). A study on those with chronic
inflammatory disease found a three-fold reduction in immune response
generated by vaccination in comparison to immunocompetent adults,
including a 36 fold reduction for those receiving B cell depletion
therapies (Deepak et al., April 9, 2021). Furthermore, the
Australian Agency for Clinical Innovation issued a summary detailing
significant concerns about the efficacy for vaccination for
immunocompromised persons and need for these individuals to continue
using non-pharmaceutical interventions (ACI, April 28, 2021). While
vaccines are a highly effective tool to minimize infections, it
cannot be overlooked that it is likely not an effective means of
control for all individuals.
---------------------------------------------------------------------------
These factors, along with the uneven vaccination rates among some
sub-populations, make the need for this ETS especially acute. For
example, the Latinx and Black populations who have been
disproportionately harmed by the virus also have the lowest vaccination
rates (Ndugga et al., February 18, 2021; CDC, May 24, 2021a). This ETS
can help facilitate vaccination among those groups, protect those who
cannot or will not be vaccinated, and thereby mitigate the
disproportionate impacts of the virus for workers in these groups.
Even when the ETS helps currently unvaccinated workers overcome the
obstacles to becoming vaccinated, they must still be protected by the
other measures of this standard until they are fully protected by the
vaccine. With the two-dose vaccines in particular, the time from a
first shot to fully effective vaccination is 5 to 6 weeks.
Furthermore, also increasing are new virus variants, the most
prevalent of which, the B.1.1.7 variant first identified in the U.K.,
now appears responsible for almost 66% of the cases in the U.S (CDC,
May 24, 2021b). While the currently authorized vaccines appear
effective against all of the variants now circulating, promoting
vaccination as quickly as possible becomes even more critical because
the variant is not only more transmissible, it also appears to cause
more severe disease.
Finally, while the science continues to develop, the full extent
and duration of the immune response remains unknown. Additional
evidence is also needed to determine the extent to which people who are
vaccinated could still be infected and transmit the disease to others,
even if they themselves are protected from the worst health effects.
Although such cases do not appear to be common, the ETS would help
protect these employees and their co-workers in mixed groups of
vaccinated and unvaccinated people.
These issues, as elaborated further in the discussion of Grave
Danger, demonstrate that the various protections required in this ETS
are still necessary, even for workplaces in which many but not all
members of the workforce have been vaccinated.
This pandemic has taken a devastating toll on all of American
society, and addressing it requires a whole-of-government response
(White House, April 2, 2021). This ETS is part of that response. OSHA
shares the nation's hope for the promise of recovery created by the
vaccines. But in the meantime, it also recognizes that measures to
mitigate the spread of COVID-19, including encouraging and facilitating
vaccination, are still necessary in the settings covered by this
standard. However, although OSHA finds it necessary to continue these
mitigation measures for the immediate future, the agency will adjust as
conditions change. As more of the workforce becomes vaccinated and the
post-vaccination evidence base continues to grow, and the CDC updates
its guidance, OSHA will withdraw or modify the ETS to the extent the
workplace hazard is substantially diminished in the settings covered by
this ETS. However, at this point in time, the available evidence
indicates that the ETS is still necessary to protect employees in the
settings covered by this ETS, and the potential for higher immunity
rates later on does not obviate the need to implement the ETS now.
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at Increased Risk. http://www.oig.dol.gov/public/reports/oa/2021/19-21-003-10-105.pdf. (DOL OIG, February 25, 2021).
World Health Organization (WHO). (2009). WHO Guidelines on Hand
Hygiene in Health Care: A Summary--First Global Patient Safety
Challenge Clean Care is Safer Care. (WHO, 2009).
The White House. (2021, April 2). Press Briefing by White House
COVID-19 Response Team and Public Health Officials. https://www.whitehouse.gov/briefing-room/press-briefings/2021/04/02/press-briefing-by-white-house-covid-19-response-team-and-public-health-officials-23/. (The White House, April 2, 2021).
V. Need for Specific Provisions of the ETS
Grave Danger (Section IV.A. of the preamble) identifies the danger
of exposure to SARS-CoV-2 for healthcare workers and explains how the
SARS-CoV-2 virus is transmitted. This section, on Need for Specific
Provisions, examines the scientific underpinnings for the controls that
OSHA has identified to stop that transmission in workplaces. In Section
VIII, the Summary and Explanation for the various provisions of the
ETS, OSHA
explains how those controls must be implemented in the workplace. Not
all of the requirements of the ETS are examined in this Need for
Specific Provisions section. Some are addressed fully in the Summary
and Explanation sections.
A. Introduction--Effective Infection Prevention Utilizes Overlapping
Controls
An effective infection prevention program utilizing a suite of
overlapping controls in a layered approach better ensures that no
inherent weakness in any one approach results in an infection incident.
OSHA emphasizes that each of the infection prevention practices
required by the ETS provide some protection from COVID-19 by
themselves, but work best when used together, layering their protective
impact to boost overall effectiveness. A common depiction of this
approach in use is Reason's model of accident causation dynamics, more
commonly referred to as the ``Swiss Cheese Model of Accident
Causation'' (Reason, April 12, 1990). Reason combined concepts of
pathogen transmission and airplane accidents to present a model that
illustrated that accidents are the result of the interrelatedness of
imperfect defenses and unsafe actions that are largely unobservable
until an adverse outcome becomes apparent. Using the Swiss cheese
analogy, each control has certain weaknesses or ``holes.'' The
``holes'' differ between different controls. By stacking several
controls together with different weaknesses, the ``holes'' are blocked
by the strengths of the other controls. In other words, if controls
with different weaknesses are layered, then any unexpected failure of a
single control is protected against by the strengths of other controls.
The model provides a guiding approach to reduce incidents across many
sectors (Reason et al., October 30, 2006) and that perspective is
reflected in widely accepted approaches to controlling infectious
diseases (HICPAC, January 1, 1996; Rusnak et al., July 31, 2004; CDC,
2012; WHO, 2016).
The CDC Healthcare Infection Control Practices Advisory Committee's
(HICPAC) Isolation Guidelines, which apply to healthcare settings, are
an example of established national guidelines that illustrate layered
controls to prevent the transmission of infectious diseases (Siegel et
al., 2007). The Isolation Guidelines recommend two tiers of
precautions: Standard Precautions and Transmission-Based Precautions
(e.g., airborne, droplet, contact). Standard Precautions, under the
Isolation Guidelines, are the minimum infection prevention practices
that apply to patient care, regardless of the suspected or confirmed
infection status of the patient, in any setting where health care is
practiced. They are based on the principle that there is a possible
risk of disease transmission from any patient, patient sample, or
interaction with infectious material. For Standard Precautions,
guidance follows that a certain set of controls should be implemented
to reduce infectious disease transmission regardless of the diagnosis
of the patient, in part because there is always baseline risk that is
not necessarily either obvious or detectable. These precautions include
controls such as improved hand hygiene, use of personal protective
equipment, cleaning of equipment, environmental controls, handling of
bed linens, changing work practices, and patient placement. When used
in concert, these approaches protect workers from potential exposure to
infectious agents.
The Isolation Guidelines' second tier of precautions, Transmission-
Based Precautions, takes into consideration the transmission mechanism
of specific diseases and complements Standard Precautions to better
protect workers from the presence of known or suspected infectious
agents. For instance, SARS-CoV-2, the infectious agent that causes
COVID-19, is considered to be mainly transmissible through the droplet
route in most settings (though there is evidence for airborne
transmission as noted throughout this preamble). Droplet transmission
occurs by the direct spray of large droplets onto conjunctiva or mucous
membranes (e.g., the lining of the nose or mouth) of a susceptible host
when an infected person sneezes, talks, or coughs. Droplet precautions
are a suite of layered controls that are designed to prevent the direct
spray of infectious material and supplement the suite of layered
controls used for Standard Precautions. They are designed to protect
workers from infectious agents that can be expelled in large
respiratory droplets from infected individuals. These added
interventions are implemented when infection is known or suspected and
include placing patients in single rooms or physically distant within
the same room, increased mask usage, and limiting patient movement.
COVID-19 is considered capable of spreading through multiple routes of
transmission, including airborne. Thus, the CDC recommends respiratory
protection, isolation gowns, and gloves in healthcare settings to
protect workers in those settings.
While a suite of layered controls is appropriate for controlling
infectious diseases, it is important to use the hierarchy of controls
when choosing which controls to include and the order in which to
implement them. Briefly, the hierarchy of controls refers to the
concept that the best way to control for hazards is to preferentially
utilize the most effective before complementing with less effective
controls.\19\ Ideally, the hazard is eliminated, which would likely
mean using an option such as conducting a telehealth visit outside of a
patient care setting with respect to COVID-19 to ensure that there is
no shared workspace and thus no potential for employee exposure to
COVID-19. When a telehealth visit is not possible, workers must be
protected through the implementation of controls. Outside the realm of
infection control, the utilization of an engineering control or a
change in on-site work practices could alone effectively minimize a
hazard in many cases. However, infection prevention failures often are
not apparent until an outbreak occurs, resulting in many infected
workers. Therefore, it is important for employers to not only adhere to
the hierarchy of controls when identifying controls to implement, but
also to augment layers of feasible engineering controls (e.g., adequate
ventilation, barriers) with administrative and work practice controls
(e.g., physical distancing, cleaning, disinfection, telework, schedule
modification, health screening). Personal protective equipment (e.g.,
gloves, respirators, and facemasks) can provide the final layer of
control. This approach is consistent with both OSHA and CDC guidance
for protecting workers and the public from COVID-19.
---------------------------------------------------------------------------
\19\ The hierarchy of controls is a longstanding occupational
safety practice and OSHA policy. Under its hierarchy of controls
policy reflected in a number of standards, OSHA typically only
allows employers to rely on respirators or other PPE to the extent
that engineering controls to eliminate the hazard are not feasible.
See, e.g., Sec. Sec. 1910.134(a) (respiratory protection) and
1926.103 (respiratory protection); 1910.1000(e) (air contaminants);
1910.95(b) (occupational noise exposure) and 1926.101 (hearing
protection).
---------------------------------------------------------------------------
In addition to the broad recognition and implementation of layered
controls to protect against infectious diseases, a recent study
elucidated the effectiveness of isolated and layered controls, with
respect to close contacts amidst several community COVID-19 outbreaks
in Thailand (Doung-ngern et al., September 14, 2020). While individual
controls, such as wearing a face covering or maintaining at least a
minimum distance from others, significantly reduced cases (28% and 40%,
respectively), the researchers concluded
that a layered approach would be expected to reduce infections by 84%.
Several similar studies evaluated the importance of layering
controls during the 2002/2003 SARS outbreak caused by SARS-CoV-1, which
is a different strain of the same species of virus as the virus that
causes COVID-19 (SARS-CoV-2) and has some similar characteristics;
importantly, both viruses are strains of the same viral species and
exhibit the same modes of transmission. Researchers assessed five Hong
Kong hospitals on how the utilization of interventions affected SARS
transmission (Seto et al., May 3, 2003). In total, the study evaluated
244 workers on their compliance with wearing masks, gowns, and gloves
as well as adhering to hand hygiene protocols. Among the 69 workers who
fully complied with the layered controls, there were no infections.
However, 13 of 185 workers who used only some of the interventions were
infected. The researchers concluded that the combined practice of
droplet and contact precautions together significantly reduced the risk
of infection from exposures to SARS-infected individuals.
Another study investigated the approaches taken to reduce SARS-CoV-
1 transmission in hospitals in Taiwan during the 2003 portion of the
outbreak (Yen et al., February 12, 2010). Researchers surveyed forty-
eight Taiwanese hospitals that provided care for 664 SARS-CoV-1
patients, including 119 healthcare workers, to determine which controls
each hospital implemented. Control measures included isolation of fever
patients in the Emergency Department (ED), installation of handwashing
stations in the ED, routing patients from the ED to an isolation ward,
installation of fever screen stations in the ED, and installation of
handwashing stations throughout the hospital. Analysis showed that
while early SARS-CoV-1 case identification at fever screening stations
outside the hospital could reduce transmission inside the hospital by
half, combining that intervention with other interventions could almost
double that reduction.
A modeling effort to simulate an epidemic of seasonal influenza at
a hypothetical hospital in Ann Arbor, Michigan, found that different
interventions used in a layered approach would result in a greater
predicted reduction in nosocomial cases (i.e., healthcare-associated
infections) (Blanco et al., June 1, 2016). The study evaluated six
different intervention techniques thought to be effective against
influenza, including hand hygiene, employee vaccination, patient pre-
vaccination, patient isolation, therapies (e.g., antibody treatments,
steroids), and face coverings. The researchers found, based on the
model, that while no individual intervention exceeded a 27% percent
reduction in cases, utilizing all controls would prevent half of all
cases. While this model employed influenza as the vehicle to examine
the effectiveness of layered protections, it gives no reason to believe
that this approach would not be equally effective for other viruses
such as SARS-CoV-2.
In 2016, the World Health Organization, a specialized agency of the
United Nations that is focused on international public health (WHO,
2016), addressed the use of layering interventions to reduce infections
in performed systematic reviews in its ``Guidelines on Core Components
of Infection Prevention and Control Programmes at the National and
Acute Health Care Facility Level.'' OSHA's perspective of layered
interventions (e.g., engineering controls, work practice controls,
personal protective equipment, training) is consistent with what the
WHO Guidelines define as ``multimodality.'' WHO defines multimodality
as follows:
A [layered] strategy comprises several elements or components
(three or more; usually five, http://www.ihi.org/topics/bundles/Pages/default.aspx) implemented in an integrated way with the aim of
improving an outcome and changing behavior. It includes tools, such
as bundles and checklists, developed by multidisciplinary teams that
take into account local conditions. The five most common components
include: (i) System change (availability of the appropriate
infrastructure and supplies to enable infection prevention and
control good practices); (ii) education and training of health care
workers and key players (for example, managers); (iii) monitoring
infrastructures, practices, processes, outcomes and providing data
feedback; (iv) reminders in the workplace/communications; and (v)
culture change within the establishment or the strengthening of a
safety climate.
The WHO guidelines strongly recommend practicing multimodality/
layered interventions to reduce infections based on WHO's systematic
review of implementation efforts at facility-level and national scales.
Based on a systematic review of 44 studies on implementing infection
control practices at the facility level, and another systematic review
of 14 studies on the success of National rollout programs using layered
strategies, WHO concluded that using layered strategies was effective
in improving infection prevention and control practices and reducing
hospital-acquired illnesses (WHO, 2016).
Vaccination does not eliminate the need for layered controls for
healthcare workers exposed to COVID-19 patients, which can result in
exposures that are more frequent and potentially carrying higher viral
loads than those faced in workplaces not engaged in COVID-19 patient
care. The Director of the CDC's National Institute for Occupational
Health (NIOSH) recently wrote to OSHA that layers of control are still
needed for vaccinated healthcare workers who remain at ``particularly
elevated risk of being infected'' while treating COVID-19 patients:
``The available evidence shows that healthcare workers are continuing
to become infected with SARS-CoV-2, the virus that causes COVID-19,
including both vaccinated and unvaccinated workers . . . Regardless of
vaccination status, healthcare workers need additional protections such
as respirators and other personal protective equipment (PPE) during
care of patients with suspected or confirmed COVID-19.'' (Howard, May
22, 2021). Further, a recent CDC study found that despite the positive
impact on the roll-out of large-scale vaccination programs on reducing
the transmission of COVID-19, a decline in non-pharmaceutical
interventions (NPIs; e.g., physical distancing, face covering use) may
result in a resurgence of cases (Borchering, May 5, 2021). The authors
concluded that vaccination coverage in addition to compliance with
mitigation strategies are essential to minimize COVID-19 transmission
and prevent surges in hospitalizations and deaths. Thus, to effectively
control COVID-19 transmission to those who are not vaccinated or
immune, an increase in vaccination coverage in addition to NPIs, such
as physical distancing, are crucial.
Based on the above evidence, OSHA is requiring in the ETS that
healthcare employers must not only implement the individual infection
prevention measures discussed in the following sections, but also layer
their controls to protect workers from the COVID-19 hazard due to the
additional protection provided to workers when multiple control
measures are combined.
References
Blanco, N et al., (2016, June 1). What Transmission Precautions Best
Control Influenza Spread in a Hospital. American Journal of
Epidemiology 183 (11): 1045-1054. https://doi.org/10.1093/aje/kwv293. (Blanco et al., June 1, 2016).
Borchering, RK et al., (2021, May 5). Modeling of Future COVID-19
Cases, Hospitalizations, and Deaths, by Vaccination Rates and
Nonpharmaceutical Intervention Scenarios--United States, April-
September 2021. MMWR Morb Mortal Wkly Rep. ePub: 5 May 2021. doi:
http://dx.doi.org/10.15585/mmwr.mm7019e3. (Borchering, May 5, 2021).
Centers for Disease Control and Prevention (CDC). (2012). An
Introduction to Applied Epidemiology and Biostatistics, Lesson 1:
Introduction to Epidemiology, Section 10: Chain of Infection. In:
Principles of Epidemiology in Public Health Practice, Third Edition:
http://www.cdc.gov/ophss/csels/dsepd/SS1978/Lesson1/Section10.html.
(CDC, 2012).
Doung-ngern, P et al., (2020, September 14). Case-control Study of
Use of Personal Protective Measures and Risk for SARS Coronavirus 2
Infection, Thailand. Emerg In Dis 26, 11: 2607-2616. https://doi.org/10.3201/eid2611.203003. (Doung-ngern et al., September 14,
2020) .
Hospital Infection Control Practices Advisory Committee (HICPAC).
(1996, January 1). Guideline for isolation precautions in hospitals.
Infection Control and Hospital Epidemiology 17(1): 53-80. (HICPAC,
January 1, 1996).
Howard, J. (2021, May 22). ``Response to request for an assessment
by the National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services, of the current hazards facing healthcare
workers from Coronavirus Disease-2019 (COVID-19).'' (Howard, May 22,
2021).
Reason, J. (1990, April 12). The Contribution of Latent Human
Failures to the Breakdown of Complex Systems. Philosophical
Transactions of the Royal Society London B327475 B327484. https://dol.org/10.1098/rstb.1990.0090. (Reason et al., April 12, 1990).
Reason, J et al., (2006, October 30). Revisiting the Swiss Cheese
Model of Accidents. EUROCONTROL Experimental Centre, Note No. 13/06.
(Reason et al., October 30, 2006).
Rusnak, JM et al., (2004, July 31). Management guidelines for
laboratory exposures to agents of bioterrorism. Journal of
Occupational and Environmental Medicine 46(8): 791-800. doi:
10.1097/01.jom.0000135536.13097.8a. (Rusnak et al., July 31, 2004).
Seto, WH et al., (2003, May 3). Effectiveness of precautions against
droplets and contact in prevention of nosocomial transmission of
severe acute respiratory syndrome (SARS). The Lancet 361(9368):
1519-1520. https://doi.org/10.1016/s0140-6736(03)13168-6. (Seto et
al., May 3, 2003).
Siegel, J, Rhinehart, E, Jackson M, Chiarello, L, and the Healthcare
Infection Control Practices Advisory Committee. (2007). 2007
Guideline for isolation precautions: preventing transmission of
infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).
World Health Organization (WHO). (2016). Guidelines on Core
Components of Infection Prevention and Control Programmes at the
National and Acute Health Care Facility Level. https://www.who.int/gpsc/ipc-components-guidelines/en/. (WHO, 2016).
Yen, MY et al., (2010, February 12). Quantitative evaluation of
infection control models in the prevention of nosocomial
transmission of SARS virus to healthcare workers: implication to
nosocomial viral infection control for healthcare workers.
Scandinavian Journal of Infectious Diseases 42: 510-515. https://10.3109/00365540903582400. (Yen et al., February 12, 2010).
B. COVID-19 Plan
An effective COVID-19 plan is modeled on the core components of
safety and health programs, which utilize a systematic approach to
reduce injuries and illnesses in the workplace. The occupational safety
and health community uses various names to describe this type of
systematic approach (e.g., safety and health programs, safety and
health management systems, and injury and illness prevention programs)
and uses the terms ``plans'' and ``programs'' interchangeably. An
effective safety and health program involves proactively and
continuously identifying and mitigating hazards, before employees are
injured or develop disease. The approach involves trained employees and
managers working together to identify and address issues before the
issues become a problem. Such an approach helps employers meet their
obligation under the OSH Act to provide employees a place of employment
free from recognized hazards (OSHA, January 2012; OSHA, October 18,
2016). The COVID-19 plan required by this ETS encompasses the core
components of this type of safety and health programs. Developing and
implementing a COVID-19 plan is an essential part of an effective
response to the COVID-19 hazards present in the workplace because the
process involves identifying employees who are at risk of exposure to
the virus and determining how they can be effectively protected from
developing COVID-19 using a multi-layered approach.
Many companies that have received awards for their safety and
health accomplishments have credited safety and health programs for
their success. Because of the value, effectiveness, and feasibility of
such programs, many countries throughout North America, Asia, and
Europe require employers to implement programs to prevent injury and
illness. Numerous studies and data sources provide evidence of such
programs improving safety and health management practices and
performance which leads to reductions in injury, illness, and
fatalities. For example, a review of the impact of implementation of
safety and health programs in eight states showed a reduction of injury
and illness rates ranging from 9% to more than 60% (OSHA, January
2012). In three of these states with mandatory injury and illness
prevention programs, workplace fatality rates were up to 31% lower than
the national average (OSHA, January 2012).
OSHA has traditionally identified seven core elements of successful
safety and health programs including (1) management leadership, (2)
worker participation, (3) hazard identification and assessment, (4)
hazard prevention and controls, (5) evaluation and improvement, (6)
coordination and communication at multi-employer sites, and (7)
education and training (OSHA, January 2012; OSHA, October 18, 2016).
The COVID-19 plan required by this ETS was developed with these
elements in mind. The first core element, management leadership,
involves a demonstrated commitment to establishing a safety and health
culture and continuously improving safety and health in the workplace.
A commitment to health and safety is demonstrated by implementing a
clear plan for preventing illness and injury, and communicating the
plan to all employees (including contractors and temporary staff).
Designating a coordinator to track progress of the plan and ensure that
all aspects of the plan are implemented further demonstrates
management's commitment to employee safety and health (OSHA, 2005;
OSHA, January 2012; OSHA, October 18, 2016).
The second, and one of the most important components of a safety
and health program, is the participation of trained and knowledgeable
employees, including those employed by other employers (e.g.,
contractors, temporary staff). Employees provide unique perspective and
expertise because they are often the most knowledgeable people about
the hazards associated with their jobs and how those hazards can be
controlled. Employees who are trained to recognize hazards and
appropriate controls to address those hazards and know that they can
speak freely to employers, can provide valuable input on hazards that
need to be addressed, which can lead to a reduction in hazards or
exposure to hazards. They can also provide input on improvements that
are needed to protections that have already been implemented. An
emphasis on employee participation is consistent with the OSH Act, OSHA
standards, and
OSHA enforcement policies and procedures, which recognize the rights
and roles of workers and their representatives in matters of workplace
safety and health (OSHA, 2005; OSHA, January 2012; OSHA, October 18,
2016).
The third core element of a safety and health program approach is
hazard identification and assessment. To be most effective, hazard
assessments must be conducted as a team approach with management,
coordinators, and employees involved in the hazard assessment process
(e.g., identifying potential hazards) and the development and
implementation of the COVID-19 plan. An assessment to identify safety
and health hazards can include surveying the facility to observe
employee work habits and evaluating employee input from surveys or
meeting minutes. Specifically, the risk of exposure to biological
hazards, such as the COVID-19 virus, can be assessed by determining if
workers could be exposed (e.g., through close contact with patients,
co-workers, or members of the public; contact with contaminated
surfaces, objects, or waste) and if controls are present to mitigate
those risks (OSHA, 2005; OSHA, October 18, 2016). While a standard can
specify controls applicable to particular hazards, the hazard
assessment can help identify where controls are needed in specific
areas of a particular worksite.
The fourth core element of an effective workplace safety and health
program approach is hazard prevention and control, which involves teams
of managers, coordinators, and employees assessing if a hazard can be
eliminated (e.g., by working at home to eliminate potential virus
exposure in the workplace). When hazards cannot be eliminated, the
hazard prevention process considers which hazards can be controlled by
implementing work practices (e.g., regular cleaning, disinfecting,
physical distancing) or controls (e.g., physical barriers, improvements
to the ventilation system). Additionally, the process of hazard
prevention and control determines if PPE is required as part of a
multi-layered strategy to protect workers from infectious biological
agents (OSHA, 2005; OSHA, October 18, 2016). The controls may function
more effectively when implemented in the most targeted manner following
a hazard assessment and team-based evaluation.
The fifth core element of an effective safety and health program
approach is evaluation and improvement. Safety and health programs
require periodic evaluation to ensure they are implemented as intended
and continue to achieve the goal of preventing injury and illness. This
re-evaluation can reduce hazards, or result in improvements in controls
to help reduce hazards. Managers have the prime responsibility for
ensuring the effectiveness of the program but managers should work as a
team with coordinators and employees to continually monitor the
worksite to identify what is and is not working and make adjustments to
improve worker safety and health measures (OSHA, January 2012; OSHA,
October 18, 2016).
The sixth core element of an effective safety and health program
approach is communication and coordination between host employers,
contractors, and staffing agencies. Because the employees of one
employer may expose employees of a different employer to a hazard, this
communication is essential to protecting all employees. An effective
program ensures that before employees go to a host worksite, both the
host employer and staffing agencies communicate about hazards on the
worksite, procedures for controlling hazards, and how to resolve any
conflicts that could affect employee safety and health (e.g., who will
provide PPE). The exchange of information about each employer's plans
can help reduce exposures by identifying areas where one employer may
need to provide additional protections (barriers, timing of workshifts,
etc.) to its employees. Additionally, exchanging contact information
between employers can facilitate worker protection in case they need to
report hazards or illnesses that may occur (OSHA, October 18, 2016). In
order to reduce COVID-19 transmission in the workplace, it will be
particularly important for employers to have clear plans about how they
can quickly alert other employers if a worker at a multi-employer site
subsequently tests positive for COVID-19 and was in close contact with
workers of other employers.
The seventh core element of an effective safety and health program
is education and training. Education and training ensures that
employees, supervisors, and managers are able to recognize and control
hazards, allowing them to work more safely and contribute to the
development and implementation of the safety and health program (OSHA,
2005; OSHA, January 2012; OSHA, October 18, 2016). Later in this Need
for Specific Provisions section there is a detailed explanation about
the need for training as a separate control to minimize COVID-19
transmission.
The effectiveness of a safety and health program approach in
preventing injury and illnesses is recognized by a number of
authoritative bodies. In its Total Worker Health program, the National
Institute for Occupational Safety and Health (NIOSH) lists a number of
core elements that are consistent with OSHA's safety and health program
approaches, including demonstrating leadership commitment to safety and
health, eliminating or reducing safety and health hazards, and
promoting and supporting employee involvement (NIOSH, December 2016).
The International Organization for Standardization (ISO) developed
ISO 45001, a consensus standard to help organizations implement a
safety and health management system (ISO, 2018). ISO notes that key
potential benefits of the system include reduced workplace incidents,
establishment of a health and safety culture by encouraging active
involvement of employees in ensuring their health and safety,
reinforcement of leadership commitment to health and safety, and
improved ability to comply with regulatory requirements.
The American National Standards Institute (ANSI) and American
Society of Safety Professionals (ASSP) also developed a health and
safety management systems standard for the purpose of reducing hazards
and risk in a systematic manner, based on a team approach that includes
management commitment and employee involvement, with an emphasis on
continual improvement (ANSI/ASSP, 2019). ANSI/ASSP note the widespread
acceptance that safety and health management systems can improve
occupational safety and health performance. (Id.) They further
highlight OSHA reports of improved safety and health performance by
companies who implement programs that rely on management system
principles (e.g., the Voluntary Protection Program), and that major
professional safety and health organizations support management systems
as effective in improving safety and health. As further proof that
safety and health management systems are valuable, they note that many
large and small organizations within the U.S. and internationally are
implementing these systems.
Based on the best available evidence, OSHA concludes that a COVID-
19 plan that is modeled on the safety and health program principles
discussed above, implemented by a COVID-19 coordinator, influenced by
employee input, and continuously evaluated, is an effective tool to
ensure comprehensive identification and mitigation of COVID-19 hazards.
As a result, OSHA concludes that a COVID-19 plan will reduce the
incidence of COVID-19 in
the workplace by helping to ensure that all effective measures are
implemented as part of a multi-layered strategy to minimize employee
exposure to COVID-19.
References
American National Standards Institute (ANSI)/American Society of
Safety Professionals (ASSP). (2019). ANSI/ASSP Z10.0-2019.
Occupational Health and Safety Management Systems. (ANSI/ASSP,
2019).
International Organization for Standardization (ISO). (2018).
Occupational health and safety. ISO 45001. (ISO, 2018).
National Institute for Occupational Safety and Health (NIOSH).
(2016, December). Fundamentals of total worker health approaches:
essential elements for advancing worker safety, health, and well-
being. Publication no. 2017-112. https://www.cdc.gov/niosh/docs/2017-112/pdfs/2017_112.pdf. (NIOSH, December 2016).
Occupational Safety and Health Administration (OSHA). (2005). Small
Business Handbook. Small Business Safety and Health Management
Series. OSHA 2209 02R 2005. https://www.osha.gov/sites/default/files/publications/small-business.pdf. (OSHA, 2005).
Occupational Safety and Health Administration (OSHA). (2012,
January). Injury and Illness Prevention Programs. White Paper.
https://www.osha.gov/dsg/InjuryIllnessPreventionProgramsWhitePaper.html. (OSHA, January
2012).
Occupational Safety and Health Administration (OSHA). (2016, October
18). Recommended Practices for Safety and Health Programs. OSHA
3885. https://www.osha.gov/sites/default/files/publications/OSHA3885.pdf. (OSHA, October 18, 2016).
C. Patient Screening and Management
Limited contact with potentially infectious persons is a
cornerstone of COVID-19 pandemic management. For example, screening and
triage of everyone entering a healthcare setting is an essential means
of identifying those individuals who have symptoms that could indicate
infection with the SARS-CoV-2 virus (CDC, February 23, 2021). Persons
with such symptoms can then be triaged appropriately to minimize
exposure risk to employees. CDC guidance provides a number of
approaches for screening and triage, including screening at entry,
separate triage areas for patients desiring evaluation for COVID-19
concerns, and electronic pre-screening prior to arrival (CDC, February
23, 2021). Once identified, potentially infected individuals can then
be isolated for evaluation, testing, and treatment. Triage increases
the likelihood of implementation of the appropriate level of personal
protective equipment for employees and other protections required for
exposure to potentially infectious patients. Patient segregation in
healthcare settings also reduces nosocomial (healthcare-acquired)
infections for employees. Inpatients continue to require regular re-
evaluation for COVID-19 symptoms.\20\
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\20\ Limiting and monitoring points of entry to the setting will
also help limit contact with potentially infectious persons. For
further discussion, see the Need for Specific Provisions for
Physical Distancing.
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Symptoms-based screening is a standard component of infection
control. This approach was recommended during the 2003 SARS epidemic
(caused by SARS-CoV-1, a different strain of SARS) and is routinely
recommended for airborne infections such as M. tuberculosis and
measles, and as a general practice in infection control programs
(Siegel et al., 2007). Because SARS-CoV-2 can be transmitted by
individuals who are infected but do not have symptoms (asymptomatic and
presymptomatic transmission), symptom-based screening will not identify
all infectious individuals (Viswanathan et al., September 15, 2020).
However, persons with symptoms early in their SARS-CoV-2 infection are
among the most infectious (Cevik et al., November 19, 2020). Therefore,
symptom-based screening will identify some of the highest-risk
individuals for SARS-CoV-2 transmission and thereby reduce the risk to
workers.
References
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Cevik, M. et al., (2020, November). SARS-CoV-2, SARS-CoV, and MERS-
CoV viral load dynamics, duration of viral shedding, and
infectiousness: A systematic review and meta-analysis. Lancet
Microbe 2021; 2: e13-22. https://doi.org/10.1016/S2666-5247(20)30172-5. (Cevik et al., November 19, 2020).
Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L.
(2007). Guideline for isolation precautions: Preventing transmission
of infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).
Viswanathan, M. et al., (2020, September 15). Universal screening
for SARS-CoV-2 infection: A rapid review. Cochrane Database of
Systematic Reviews, Issue 9. Art. No.: CD013718. DOI: 10.1002/
14651858.CD013718. (Viswanathan et al., September 15, 2020).
D. Standard and Transmission-Based Precautions
Standard and Transmission-Based Precautions are well-accepted as
important to controlling disease transmission (HICPAC, December 27,
2018; CDC, January 7, 2016). It should be noted that during times of
significant transmission, such as during this pandemic, additional
protections are needed to supplement the basic level of recommended
precautions and practices in these guidelines. For instance, wearing at
least a facemask regardless of interaction with known or suspected
infectious patients is needed during the pandemic (CDC, February 23,
2021).
Standard Precautions refers to infection prevention practices,
implemented in healthcare settings, where the presence of an infectious
agent is assumed (i.e., without the suspicion or confirmation of
exposure). The use of Standard Precautions thus relies on the
assumption that all patients, patient samples, potentially contaminated
materials (e.g., patient laundry, medical waste), and human remains in
healthcare settings are potentially infected or colonized with an
infectious agent(s). For example, Standard Precautions would include
appropriate hand hygiene and use of personal protective equipment as
well as practices to ensure respiratory hygiene, sharps safety, safe
injection practices, and sterilization and disinfection of equipment
and surfaces (CDC, February 23, 2021).
Transmission-Based Precautions add an additional layer of
protection to Standard Precautions. Transmission-Based Precautions
refers to those good infection prevention practices, used in tandem
with Standard Precautions that are based on the way an infectious
agent(s) may be transmitted. These precautions are needed, for example,
when treating a patient where it is suspected or confirmed that the
patient may be infected or colonized with agents that are infectious
through specific routes of exposure (Siegel et al., 2007). For example,
handwashing and safe handling of sharps (needles, etc.) are routine
Standard Precautions. An infectious agent capable of airborne
transmission through aerosols would require patient care in an airborne
infection isolation room (AIIR), if available, under Transmission-Based
Precautions.
Even before a patient is treated, certain Transmission-Based
Precautions
can be critical to protecting healthcare workers. For example, one
typical precaution is that patients and visitors who enter a waiting
room before being seen or triaged must wear facemasks, or face
coverings, as a source control device to prevent them from spreading
airborne droplets near the employees. These source control devices may
also be critical to reducing the likelihood that COVID-19 is spread as
the patients are transported from the admission area to a treatment
area.
The critical need for implementing Standard and Transmission-Based
Precautions in healthcare settings is evident in the Healthcare
Infection Control Practices Advisory Committee's (HICPAC's) 2017 Core
Infection Prevention and Control Practices for Safe Healthcare Delivery
in All Settings.\21\ The core practices included in that document
include Standard and Transmission-Based Precautions, which, HICPAC
recommended, need to be implemented in all settings where healthcare is
delivered.
---------------------------------------------------------------------------
\21\ HICPAC is a federal advisory committee that provides
guidance to the CDC and the Secretary of the Department of Health
and Human Services (HHS) regarding the practice of infection
control. In March 2013, CDC charged HICPAC with a review of existing
CDC guidelines to identify all recommendations that warrant
inclusion as core practices. In response, a HICPAC workgroup was
formed that contained representatives from the following stakeholder
organizations: America's Essential Hospitals, the Association for
Professionals in Infection Control and Epidemiology (APIC), the
Council of State and Territorial Epidemiologists (CSTE), the Public
Health Agency of Canada (PHAC), the Society for Healthcare
Epidemiology of America (SHEA), and the Society of Hospital Medicine
(SHM) (HICPAC, March 15, 2017). This process resulted in HICPAC's
Core Infection Prevention and Control Practices for Safe Healthcare
Delivery in All Settings.
---------------------------------------------------------------------------
That Standard and Transmission-Based Precautions are a long-
standing and essential element of infection control in healthcare
industries is also evidenced by the CDC's 2007 Guideline for Isolation
Precautions: Preventing Transmission of Infectious Agents in Healthcare
Settings, which incorporate Standard and Transmission-Based Precautions
into their recommendations. This 2007 Guideline updated 1996
guidelines, which introduced the concept of Standard Precautions and
also noted the existence of infection control recommendations dating
back to 1970 (Siegel et al., 2007).
Both Standard and Transmission-Based Precautions are recommended by
the CDC for healthcare personnel during the COVID-19 pandemic (CDC,
February 23, 2021). The CDC considers healthcare personnel (HCP) to
include all paid and unpaid persons serving in healthcare settings who
have the potential for direct or indirect exposure to patients or
infectious materials, including body substances (e.g., blood, tissue,
and specific body fluids); contaminated medical supplies, devices, and
equipment; contaminated environmental surfaces; or contaminated air.
HCP include, but are not limited to, emergency medical service
personnel, nurses, nursing assistants, home healthcare personnel,
physicians, technicians, therapists, phlebotomists, pharmacists,
students and trainees, contractual staff not employed by the healthcare
facility, and persons not directly involved in patient care, but who
could be exposed to infectious agents that can be transmitted in the
healthcare setting (e.g., clerical, dietary, environmental services,
laundry, security, engineering and facilities management,
administrative, billing, and volunteer personnel).
The CDC also has recommendations for protection of workers in
industries associated with healthcare. According to the CDC's Interim
Infection Prevention and Control Recommendations for Healthcare
Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic
(incorporated by reference, Sec. 1910.509), on-site management of
laundry, food service utensils, and medical waste should also be
performed in accordance with routine procedures (CDC, February 23,
2021).
The work of the College of American Pathologists (CAP) illustrates
the importance of taking core precautionary measures in healthcare
industries during the pandemic. CAP has provided recommendations for
staff protection during the COVID-19 pandemic. For example, CAP has
provided COVID-19-specific autopsy recommendations which include
biosafety considerations such as performing autopsies on COVID-19-
positive cases in an airborne infection isolation room (College of
American Pathologists, February 2, 2021).\22\
---------------------------------------------------------------------------
\22\ CAP is known for its peer-based Laboratory Accreditation
Program. The Centers for Medicare & Medicaid Services (CMS) allows a
CAP inspection in lieu of a CMS inspection. CAP inspections have a
similar status with a number of other leading healthcare and
biomedical laboratory authorities including the Joint Commission,
United Network for Organ Sharing, the National Marrow Donor Program,
the Foundation for the Accreditation of Cellular Therapies, and many
state agencies (College of American Pathologists, February 1,
2021b). CAP has worked with the CMS to implement virtual laboratory
inspections allowing labs to remain in compliance with Clinical
Laboratory Improvement Amendments regulations (College of American
Pathologists, February 1, 2021a).
---------------------------------------------------------------------------
The Standard and Transmission-Based Precautions required by the ETS
only extend to exposure to SARS-CoV-2 and COVID-19 protection. The
agency does not intend the ETS to apply to other workplace hazards.
References
Centers for Disease Control and Prevention (CDC). (2016, January 7).
Transmission-based precautions. https://www.cdc.gov/infectioncontrol/basics/transmission-based-precautions.html. (CDC,
January 7, 2016).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
College of American Pathologists. (2021, February 2). Amended COVID-
19 autopsy guideline statement from the CAP Autopsy Committee.
https://documents.cap.org/documents/COVID-Autopsy-Statement.pdf.
(College of American Pathologists, February 2, 2021).
Healthcare Infection Control Practices Advisory Committee (HICPAC).
(2018, December 27). Core infection prevention and control practices
for safe healthcare delivery in all settings. https://www.cdc.gov/hicpac/recommendations/core-practices.html. (HICPAC, December 27,
2018).
Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L.
(2007). Guideline for isolation precautions: Preventing transmission
of infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).
E. Personal Protective Equipment (PPE)
As previously discussed in Grave Danger (Section IV.A. of the
preamble), COVID-19 infections occur mainly through exposure to
respiratory droplets (referred to as droplet transmission) when a
person is in close contact with someone who has COVID-19. COVID-19 can
sometimes also be spread by airborne transmission (CDC, May 13, 2021).
As the CDC explains, when people with COVID-19 cough, sneeze, sing,
talk, or breathe, they produce respiratory droplets, which can travel a
limited distance--thereby potentially infecting people within close
physical proximity--before falling out of the air due to gravity.
Facemasks, face coverings, and face shields are all devices used for
their role in reducing the risk of droplet, and potentially airborne,
transmission of COVID-19 primarily at the source. Additional discussion
on the efficacy of each device, and the need for facemasks and face
shields specifically, is explained below. (Respirator use is also
included in the ETS and more information on the
need for respirators to prevent the spread of COVID-19 is discussed in
the Need for Specific Provisions for Respirators, further below.)
Well-fitting facemasks, not face coverings, are the baseline
requirement in healthcare settings because of their fluid resistant
qualities (discussed in detail below). However, the role of facemasks
and face coverings are otherwise similar in source control and personal
protection for the wearer. OSHA's position on the importance of face
coverings and facemasks is supported by a substantial body of evidence.
Consistent and correct use of face coverings and facemasks is widely
recognized and scientifically supported as an important evidence-based
strategy for COVID-19 control. Accordingly, with specific exceptions
relevant to outdoor areas and vaccinated persons, the CDC recommends
everyone two years of age and older wear a face covering in public
settings and when around people outside of their household (CDC, April
19, 2021). And, on January 21, 2021, President Biden issued Executive
Order 13998, which recognizes the use of face coverings or facemasks as
a necessary, science-based public health measure to prevent the spread
of COVID-19, and therefore directed regulatory action to require that
they be worn in compliance with CDC guidance while traveling on public
transportation (e.g., buses, trains, subway) and while at airports
(Executive Order 13998, 86 FR 7205, 7205 (Jan. 21, 2021); CDC, February
2, 2021). Similarly, the World Health Organization (WHO) has recognized
face coverings as a key measure in suppressing COVID-19 transmission,
and thus, saving lives. The WHO observes that face coverings (and
facemasks) serve two purposes, to both protect healthy people from
acquiring COVID-19 and to prevent sick people from further spreading it
(WHO, December 1, 2020).
I. Need for Facemasks
Facemasks are simple bi-directional barriers that tend to keep
droplets, and to a lesser extent airborne particulates, on the side of
the filter from which they originate. The term ``facemask,'' as used in
this ETS, is defined as a surgical, medical procedure, dental, or
isolation mask that is FDA-cleared, FDA-authorized, or offered or
distributed as described in an FDA enforcement policy. These are most
commonly referred to as ``surgical masks'' or ``medical procedure
masks.'' As previously mentioned, facemasks reduce the risk of droplet
transmission through their dual function as both source control and
personal protection (OSHA, January 28, 2021; Siegel et al., 2007). In
healthcare settings, facemasks have long been recognized as an
important method of source control for preventing the spread of
infectious agents transmitted via respiratory droplets (e.g., in the
operating room to prevent provider saliva and respiratory secretions
from contaminating the surgical field and infecting patients). However,
facemasks do not filter out very small airborne particles and do not
provide complete protection even from larger particles because the mask
seal is not tight (FDA, December 7, 2020).
Facemasks are designed and regulated through various FDA processes
to protect the person wearing them. Not all devices that resemble
facemasks are FDA-cleared or authorized. To receive FDA clearance,
manufacturers are required to submit an FDA premarket notification
(also known as a 510(k) notification) for new products. Data in the
510(k) submission must show that the facemask is substantially
equivalent to a facemask already on the market in terms of safety and
effectiveness. Facemasks are tested for fluid resistance, filtration
efficiency (particulate filtration efficiency and bacterial filtration
efficiency), differential pressure, flammability and biocompatibility
(FDA, July 14, 2004).\23\
---------------------------------------------------------------------------
\23\ Medical devices are subject to premarket review through
risk-based classification under the Federal Food, Drug, and Cosmetic
Act. Premarket approval (PMA) applies to the highest-risk, Class III
devices, and 510(k) notification applies to most Class II and some
Class I devices. Under the 510(k) notification pathway, FDA
determines whether the device is substantially equivalent to a
lawfully marketed predicate device. Medical device manufacturers are
required to submit a 510(k) notification if they intend to introduce
a device into commercial distribution for the first time or
reintroduce a device that will be significantly changed or modified
to the extent that its safety or effectiveness could be affected.
Such change or modification could relate to the design, material,
chemical composition, energy source, manufacturing process, or
intended use. For more information, see https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device and https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances.
---------------------------------------------------------------------------
Research developed during the current SARS-CoV-2 pandemic provides
evidence of the protection afforded by facemasks. First, a universal
surgical masking requirement for all healthcare workers and patients
was implemented in Spring 2020 in the Mass General Brigham healthcare
system, which is the largest in Massachusetts (Wang et al., July 14,
2020). Based on daily infection rates among healthcare workers, the
authors found that universal masking was associated with a
significantly lower rate of SARS-CoV-2 positivity. Although the authors
noted that other interventions, such as restricting visitors, were also
put in place, they concluded that their results supported universal
masking as part of a multi-pronged infection reduction strategy in
healthcare settings.
Second, a systematic review and meta-analysis evaluated research on
healthcare workers exposed to SARS-CoV-2, as well as the SARS and
Middle East respiratory syndrome (MERS) viruses (Chu et al., June 27,
2020). Six studies compared the odds of infection in those who wore
surgical or similar facemasks compared to those who did not wear any
facemask; four of the six studies were on healthcare workers and all
six were from the 2003 SARS epidemic. Participants who wore surgical or
similar facemasks had only a third of the infection risk of those who
did not wear any facemask.
Third, a review of respiratory protection for healthcare workers
during pandemics noted that surgical mask material has been shown to
protect against more than 95% of viral aerosols under laboratory
conditions (Garcia-Godoy et al., May 5, 2020). The authors also
reviewed research showing that surgical masks reduced aerosolized
influenza exposure by an average of six-fold, depending on mask
design.\24\
---------------------------------------------------------------------------
\24\ For a discussion of the efficacy of respirators over
facemasks for protection against aerosolized particles, please see
the respirator discussion in the Need for Specific Provisions
section, below.
---------------------------------------------------------------------------
Finally, in one epidemiological study, a specialized team of
contact tracers at Duke University Health System in North Carolina
categorized recorded COVID-19 cases among their healthcare workers
(Seidelman et al., June 25, 2020). Of the cases that were categorized
as healthcare-acquired (meaning acquired as a result of either an
unmasked exposure for greater than 10 minutes at less than 6 feet to
another healthcare worker who was symptomatic and tested positive for
the virus, or an exposure to a COVID-19-positive patient while not
wearing all CDC-recommended PPE or while there was a breach in PPE),
70% were linked to an unmasked exposure to another healthcare worker.
Although cloth face coverings have gained widespread use outside of
healthcare settings during this pandemic, OSHA has determined that
cloth face coverings do not offer sufficient protection for covered
healthcare workers for multiple reasons. First, cloth face coverings,
as defined by the CDC, encompass such a wide variety of coverings that
there is no assurance
of any consistent protection to the wearer, and even source protection
can vary significantly depending on the construction and fit of the
face covering. Second, a number of studies suggest that, properly worn
over the nose and mouth, facemasks provide better protection than face
coverings, which is an important consideration in healthcare settings
where there are regular, known exposures to COVID-19-positive persons.
For example, one randomized trial of cloth face coverings compared
rates of clinical respiratory illness, influenza-like illness, and
laboratory-confirmed respiratory virus infections in 1,607 healthcare
workers in 14 hospitals in Vietnam (MacIntyre et al., March 26, 2015).
Infection risks were statistically higher in the cloth face covering
group compared to the facemask group: The risk of influenza-like
illness was 6.6 times higher, and the risk of laboratory-confirmed
respiratory virus infection was 1.7 times higher, in those who wore
cloth face coverings compared to those who wore facemasks. Another
study which reviewed respiratory protection for healthcare workers
during pandemics showed greater protection from surgical masks compared
to face coverings (Garcia-Godoy et al., May 5, 2020). Finally, Ueki et
al., (June 25, 2020) evaluated the effectiveness of cotton face
coverings, facemasks, and N95s (a commonly used respirator) in
preventing transmission of SARS-CoV-2 using a laboratory experimental
setting with manikins. The researchers found that all offerings
provided some measure of protection as source control, limiting
droplets expelled from both infected and uninfected wearers, but that
facemasks and N95s provided better protection than cotton face
coverings. Specifically, the researchers found that when spaced roughly
20 inches apart, if both an infected and uninfected individual were
wearing a cotton face covering, the uninfected person reduced
inhalation of infectious virus by 67%. But if both individuals were
wearing facemasks, exposure was reduced by 76% and when an infected
individual was wearing an N95, exposure was reduced by 96%.
Third, cloth face coverings do not function as a barrier to protect
employees from hazards such as splashes or large droplets of blood or
bodily fluids, which is a common hazard in healthcare settings. And
finally, OSHA has previously established that medical facemasks are
essential PPE for many workers in healthcare, as enforced under both
the PPE standard (29 CFR 1910.132) and more specifically, the
Bloodborne Pathogens standard (29 CFR 1910.1030).
Given the health outcomes related to COVID-19 and the exposure
characteristics found in healthcare settings (e.g., splashes or large
droplets of blood or bodily fluids), OSHA has determined that cloth
face coverings are not appropriate for workers in these settings.
Research clearly indicates that facemasks provide essential protection
for workers in covered healthcare settings.
II. Need for Face Shields
The term ``face shield,'' as used in this ETS, is a device
typically made of clear plastic, that covers the wearer's eyes, nose,
and mouth, wraps around the sides of the wearer's face, and extends
below the wearer's chin. Face shields have long been recognized as
effective in preventing splashes, splatters, and sprays of bodily
fluids and have a role in preventing the primary route of droplet
transmission, although not aerosolized transmission. As explained
above, OSHA has determined based on the best available evidence that
facemask usage is a necessary protective measure to prevent the spread
of COVID-19 for any covered employee. However, the use of face shields,
a less protective barrier, is permitted to either supplement facemasks
where there is a particular risk of droplet exposure, or as an
alternative option in certain limited circumstances where facemask
usage is not feasible.
Face shields are proven to provide some protection to the wearer
from exposure to droplets, and OSHA has long considered face shields to
be PPE under the general PPE standard (29 CFR 1910.132) and the Eye and
Face Protection standard (29 CFR 1910.133) for protection of the face
and eyes from splashes and sprays. The potential protective value of
face shields against droplet transmission is supported by a 2014 study,
in which NIOSH investigated the effectiveness of face shields in
preventing the transmission of viral respiratory diseases. The purpose
of the study was to quantify exposure of cough aerosol droplets and
examine the efficacy of face shields in reducing this exposure.
Although face shields were not found to be effective against smaller
particles, which can remain airborne for extended periods and can
easily flow around a face shield to be inhaled, the face shields were
effective in blocking larger aerosol particles (median size of 8.5
[micro]M). Face shields worn over a respirator also reduced surface
contamination of the respirator by 97%. The study's final conclusion
was that face shields can be a useful complement to respiratory
protections; however, they cannot be used as a substitute for
respiratory protection, when needed (Lindsley et al., June 27, 2014). A
recent update of the Lindsley study (Lindsley et al., January 7, 2021)
found that face shields blocked only 2% of aerosol produced by
coughing. These findings suggest that face shields might be a relevant
form of protection in healthcare settings to protect employees from
droplet exposure when they could have close contact with individuals
who are potentially infected with COVID-19.
Face shields have proven less effective as a method of source
control or a method of personal protection than facemasks. For example,
in considering face shields' value as source control, Verma et al.,
(June 30, 2020) observed the effect of a face shield on respiratory
droplets produced by simulating coughs or sneezes with a manikin. The
face shield initially blocked the forward motion of the droplet stream,
but droplets were then able to flow around the shield and into the
surrounding area. The study authors concluded that face shields alone
may not be as effective in blocking droplets.
In another study, Stephenson et al., (February 12, 2021) evaluated
the effectiveness of face coverings, facemasks, and face shields in
reducing droplet transmission. Breathing was simulated in two manikin
heads (a transmitter and receiver) that were placed four feet apart.
Artificial saliva containing a marker simulating viral genetic material
was used to generate droplets from the transmitter head. The
researchers found that face coverings, facemasks, and face shields all
reduced the amount of surrogate genetic material measured in the
environment and the amount that reached the receiver manikin head at
four feet. While face shields reduced surrogate genetic material by
98.6% in the environment and 95.2% at the receiver, genetic material
was still deposited downward in the immediate area of the transmitter,
suggesting that use of face shields without a facemask could result in
a contamination of shared surfaces. This limits the effectiveness of
face shields alone as a method of source control for shared workspaces.
Additionally, face shields used as personal protective devices showed
that the face shields protected the wearer from large cough aerosols
directed at the face, but were much less effective against smaller
aerosols which were able to flow around the edges of the shield and be
inhaled (Lindsley et al., June 27, 2014).
Based on this evidence, OSHA has determined that face shields are
not
generally appropriate as a substitute for a facemask because they are
less effective at reducing the risk of droplet and potential airborne
transmission. However, face shields do offer some protection from
droplet transmission and are, accordingly, required by the ETS to be
used in any circumstance where, for example, an individual may not be
able to wear a facemask due to a medical condition or due to other
hazards (e.g., heat stress, arc flash fire hazards). In such limited
(and often temporary) situations, a face shield may be the most
effective measure to add a layer of protection to reduce workers'
overall COVID-19 transmission risk, particularly when combined with
other protective measures.
Additionally, OSHA recognizes that face shields can provide some
additional protection when used in addition to a facemask by protecting
the wearer's eyes and preventing their facemask from being contaminated
with respiratory droplets from other persons. This additional
protection may be particularly useful for employees who cannot avoid
close contact with others or are unable to work behind barriers.
Accordingly, the ETS allows employers to require face shields in
addition to facemasks where employment circumstances might warrant the
additional protection.
OSHA has always considered recognized consensus standards, with
design and construction specifications, when determining the PPE
requirements of the agency's standards, as required by the OSH Act (29
U.S.C. 655(b)(8)) and the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).
The agency has already incorporated by reference the ANSI/ISEA
Z87.1, Occupational and Educational Personal Eye and Face Protection
Devices consensus standard for face shields in its Eye and Face
Protection standard (29 CFR 1910.133). In this ETS the agency will
incorporate by reference more recent editions of the ANSI/ISEA standard
than are currently provided for in the existing standard. Additionally,
for the limited purpose of complying with the ETS, the agency will also
allow any face shield that meets the criteria outlined in the
definition of ``face shield'' found in the definition sections of the
ETS. That is: (1) Certified to the ANSI/ISEA Z87.1-2010, 2015, or 2020
standard; or (2) covers the wearer's eyes, nose, and mouth to protect
from splashes, sprays, and spatter of body fluids, wraps around the
sides of the wearer's face (i.e., temple-to-temple), and extends below
the wearer's chin. Any face shield that is worn for the purpose of
complying with any OSHA standard other than Subpart U must still meet
the requirements of 29 CFR 1910.133.
III. Need for Other Types of PPE
Gloves and gowns (overgarments) are the two most common types of
PPE used in healthcare settings. A major principle of Standard
Precautions is that all blood and body fluids, whether from a patient,
patient sample, or infectious material, may contain transmissible
infectious agents (Siegel et al., 2007). Therefore, gloves and gowns
(overgarments) are required for certain examinations and all
procedures. These include everything from venipuncture to removing
medical waste to intubation. Similarly, gowns or similar protective
clothing are necessary for any activities in which splashes or clothing
contamination is possible. This applies as part of Standard Precautions
as well as for care of patients on Contact Precautions where
unintentional contact with contaminated environmental surfaces must be
avoided (Siegel et al., 2007).
Eye protection in the form of goggles or face shields (as discussed
above) can be used with facemasks to protect mucous membranes (eyes,
nose, and mouth) in situations where, for example, sprays of blood or
body fluids are possible. CDC recommends that healthcare workers wear
eye protection during patient care encounters to ensure eyes are
protected from infectious bodily fluids (CDC, February 23, 2021).
IV. Conclusion
In closing, the best available experimental and epidemiological
data support consistent use of facemasks in healthcare work settings to
reduce the spread of COVID-19 through droplet transmission. Adopting
facemask policies is necessary, as part of a multi-layered strategy
combined with other non-pharmaceutical interventions such as physical
distancing, hand hygiene, and adequate ventilation, to protect
employees from COVID-19. Based on the proven effectiveness of facemask
use and the effectiveness of face shields in preventing contamination
of facemasks and protecting the eyes when there is a particular risk of
droplet exposure, OSHA's COVID-19 ETS includes necessary provisions for
required use of facemasks and face shields (e.g., either as a
complementary device or in such circumstances where it is not
appropriate or possible to wear a facemask). The ETS also requires
additional PPE, such as gloves, gowns, and eye protection, in certain
limited circumstances where there is likely exposure to persons with
COVID-19.
References
Centers for Disease Control and Prevention (CDC). (2021, February
2). Order under Section 361 of the Public Health Service Act (42
U.S.C. 264) and 42 Code of Federal Regulations 70.2, 71.31(b),
71.32(b). Federal Register notice: wearing of face masks while on
conveyances and at transportation hubs. https://www.cdc.gov/quarantine/masks/mask-travel-guidance.html. (CDC, February 2, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 19).
Guidance for Wearing Masks. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover-guidance.html. (CDC,
April 19, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Chu, DK et al., (2020, June 27). Physical Distancing, Face Masks,
and Eye Protection to Prevent Person-to-Person Transmission of SARS-
CoV-2 and COVID-19: a systematic review and meta-analysis. The
Lancet 395: 1973-1987. https://doi.org/10.1016/. (Chu et al., June
27, 2020).
Food and Drug Administration (FDA). (2004, July 14). Guidance for
industry and FDA staff. Surgical masks--premarket notification
[510(k)] submissions. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surgical-masks-premarket-notification-510k-submissions. (FDA, July 14, 2004).
Food and Drug Administration (FDA). (2020, December 7). N95
respirators, surgical masks, and face masks. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-and-face-masks#s2. (FDA, December 7,
2020).
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(Garcia-Godoy et al., May 5, 2020).
Lindsley, W. et al., (2014, June 27). Efficacy of face shields
against cough aerosol droplets from a cough simulator. Journal of
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10.1080/15459624.2013.877591. (Lindsley et al., June 27, 2014).
Lindsley, W. et al., (2021, January 7). Efficacy of face masks, neck
gaiters and face shields for reducing the expulsion of simulated
cough-generated aerosols. Aerosol Science and Technology, DOI:
10.1080/02786826.2020.1862409. (Lindsley et al., January 7, 2021).
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(MacIntyre et al., March 26, 2015).
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28). Frequently asked questions COVID-19. https://www.osha.gov/coronavirus/faqs. (OSHA, January 28, 2021).
Seidelman, J. et al., (2020, June 25). Universal masking is an
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December 1, 2020).
F. Respirators
I. Respirator Use in Healthcare
As noted in Grave Danger (Section IV.A. of the preamble), it is
well-accepted that COVID-19 might spread through airborne transmission
during aerosol-generating procedures (AGPs) such as intubation.
Moreover, outside of AGP scenarios, CDC has noted growing evidence that
airborne droplets and particles can remain suspended in air, travel
distances beyond 6 feet, and be breathed in by others (CDC, May 13,
2021). Grave Danger (Section IV.A. of the preamble) notes studies
showing that infectious viral particles have been collected at
distances as far as 4.8 meters away from a COVID-19 patient (Lednicky
et al., September 11, 2020), and airborne COVID-19 infection has been
identified in a Massachusetts hospital (Klompas et al., February 9,
2021). Accordingly, the CDC recommends the use of airborne Transmission
Precautions, including the use of respirators, for any healthcare
workers caring for patients with suspected or confirmed COVID-19 (CDC,
March 12, 2020). This airborne transmission risk is in addition to the
risks associated with contact and droplet transmission. Respirators
have long been recognized as an effective and mandatory means of
controlling airborne transmissible diseases and the use of this
personal protective equipment is regulated under OSHA's Respiratory
Protection standard (29 CFR 1910.134).
The CDC has issued core guidelines for when ``healthcare
personnel'' should use respiratory protection against COVID-19
infection (see Interim Infection Prevention and Control Recommendations
for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic (CDC, February 23, 2021)). These recommendations have been
based on the most currently available information about COVID-19, such
as how the virus spreads, and are applicable to all healthcare settings
in the U.S. In the guidance, the CDC defines ``healthcare settings'' as
places where healthcare is delivered, including but not limited to:
acute care facilities, long-term acute care facilities, inpatient
rehabilitation facilities, nursing homes, assisted living facilities,
home healthcare, vehicles where healthcare is delivered (e.g., mobile
clinics), and outpatient facilities (e.g., dialysis centers, physician
offices). In addition, the CDC provides examples of ``healthcare
personnel,'' which include emergency medical service personnel, nurses,
nursing assistants, home healthcare personnel, physicians, technicians,
therapists, phlebotomists, pharmacists, students and trainees,
contractual staff not employed by the healthcare facility, and persons
not directly involved in patient care, but who could be exposed to
infectious agents that can be transmitted in the healthcare setting
(e.g., clerical, dietary, environmental services, laundry, security,
engineering and facilities management, administrative, billing, and
volunteer personnel).
The CDC describes who is at greatest risk for COVID-19 infection in
a set of FAQs designed for healthcare workers (CDC, March 4, 2021). In
the FAQs, the CDC notes that those currently at greatest risk of COVID-
19 infection are persons who have had prolonged, unprotected close
contact (i.e., within 6 feet for a combined total of 15 minutes or
longer in a 24 hour period) with a patient with confirmed COVID-19,
regardless of whether the patient has symptoms. Moreover, according to
the CDC, persons frequently in congregate healthcare settings (e.g.,
nursing homes, assisted living facilities) are at increased risk of
acquiring infection because of the increased likelihood of close
contact. In the FAQs, the CDC also reports that current data suggest
that close-range aerosol transmission by droplet and inhalation, and
contact followed by self-delivery to the eyes, nose, or mouth are
likely routes of transmission for COVID-19, and that long-range aerosol
transmission, has not been a feature of the virus. The CDC further
explains that potential routes of close-range transmission include
splashes and sprays of infectious material onto mucous membranes and
inhalation of infectious virions (i.e., the active, infectious form of
a virus) exhaled by an infected person, but that the relative
contribution of each of these is not known for COVID-19.
As the CDC states in the FAQs (CDC, March 4, 2021), although
facemasks are routinely used for the care of patients with common viral
respiratory infections, N95 filtering facepiece respirators or
equivalent (e.g., elastomeric half-mask respirators) or higher-level
(e.g., full facepiece respirators or PAPRs) respirators are routinely
recommended to protect healthcare workers from emerging pathogens like
the virus that causes COVID-19, which have the potential for
transmission via small particles. The CDC further advises that while
facemasks will provide barrier protection against droplet sprays
contacting mucous membranes of the nose and mouth, they are not
designed to protect wearers from inhaling small particles. Because of
this, the CDC recommends the use of respirators for close-contact care
of patients with suspected or confirmed COVID-19. The CDC recommends
that N95 filtering facepiece respirators (FFRs) and higher-level
respirators, such as other disposable FFRs, powered air-purifying
respirators (PAPRs), and elastomeric respirators, should be used when
both barrier and respiratory protection is
needed for healthcare workers because respirators provide better fit
and filtration characteristics.
The CDC recommendations in Interim Infection Prevention and Control
Recommendations for Healthcare Personnel During the Coronavirus Disease
2019 (COVID-19) Pandemic are divided into two separate categories.
These include: (1) Recommended infection prevention and control
practices when caring for a patient with suspected or confirmed COVID-
19; and (2) recommended routine infection prevention and control
practices during the COVID-19 pandemic (CDC, February 23, 2021).
A topic of interest related to the selection and use of respirators
is their dual role as both personal protective equipment for the wearer
and also source control to reduce the potential for transmission of
potentially infectious exhaled air to others. While many filtering
facepiece respirators do not have an exhalation valve, other filtering
facepiece respirators do. The other ``higher-level'' respirators
referenced above, and in CDC guidance (e.g., half or full facepiece
elastomeric respirators and PAPRs), do have exhalation valves. An
exhalation valve is a portal in the respirator to allow unfiltered air
to leave the respirator in order to reduce breathing resistance for the
wearer and reduce moisture and heat buildup inside the respirator.
While the exhalation valve does allow some particles to escape through
the valve, it is important to compare the performance of a respirator
with an exhalation valve to other acceptable forms of source control in
order to determine if there are actually reduced levels of
effectiveness. NIOSH studied this issue and released a technical report
entitled ``Filtering Facepiece Respirators with an Exhalation Valve:
Measurements of Filtration Efficiency to Evaluate Their Potential for
Source Control'' (NIOSH, December 2020). In the report, NIOSH concluded
that respirators with exhalation valves were equally effective as
facemasks:
this study found that unmitigated FFRs with an exhalation valve that
were tested in an outward position (with particles traveling in the
direction of exhalation) have a wide range of penetration, emitting
between <1% and 55%. Further testing could measure greater particle
penetration. Even without mitigation, FFRs with exhalation valves
can reduce 0.35-[micro]m MMAD particle emissions more consistently
than surgical masks, procedure masks, cloth face coverings, or
fabric from cotton t-shirts; . . . FFRs with an exhalation valve
provide respiratory protection to the wearer, and this study
demonstrates that they can also reduce 0.35-[micro]m MMAD particle
emissions to levels similar to or better than those provided by
surgical masks and unregulated barrier face coverings.
The results that NIOSH observed can be explained in two ways.
First, the majority of the leakage takes place around the seal by the
nose and mouth, and respirators are designed to provide tight seals
around the face so that there is only minimal leakage. Facemasks, on
the other hand, do not typically seal tightly to the face and thus
significant quantities of unfiltered air with small particles will also
escape through the gaps on the side and at the nose, as well as
potentially through the fabric of less protective filter materials.
Second, the level of filtration in facemasks is highly variable, so a
wide range of filter efficiencies have been acceptable under CDC
guidance. The CDC does not recommend that respirators with exhaust
valves be used as source controls, but the CDC's last updated
recommendation on this subject was published in August of 2020, four
months before the NIOSH study, and cited lack of data as the basis for
the warning against relying on such respirators (CDC, April 9, 2021b).
Therefore, the NIOSH study with its conclusion that respirators with
exhaust valves are not less adequate as source controls than other
acceptable source controls, appears to represent the best available
evidence. OSHA therefore concludes that at this time there is no basis
for OSHA to prohibit any NIOSH-approved filtering facepiece respirator
from serving as both personal protective equipment and as source
control. The NIOSH report also details methods of covering the
filtering facepiece respirator's exhalation valve in various manners to
further improve the effectiveness as source control, which OSHA
considers a recommended practice, but not strictly necessary. There are
also other methods that can be used to cover or filter the exhalation
valve of elastomeric respirators (e.g., place a medical mask over the
respirator).
II. The CDC's Recommended Infection Prevention and Control Practices
When Caring for a Patient With Suspected or Confirmed COVID-19
The CDC recommends that healthcare personnel (including workers
that perform healthcare services and those that perform healthcare
support services) who enter the room or area of a patient with
suspected or confirmed COVID-19 adhere to Standard Precautions plus
gown, gloves, and eye protection, and also use a NIOSH-approved N95
filtering facepiece or equivalent or higher-level respirator. The CDC
notes in a set of FAQs that its recommendation to use NIOSH-approved
N95 disposable filtering facepiece or higher-level respirators when
providing care for patients with suspected or known COVID-19 is based
on the current understanding of the COVID-19 virus and related
respiratory viruses (CDC, March 10, 2021).
As noted above, the CDC recommendations listed in Interim Infection
Prevention and Control Recommendations for Healthcare Personnel During
the Coronavirus Disease 2019 (COVID-19) Pandemic are applicable to all
U.S. settings where healthcare is delivered. To this end, the
recommendations on respirator use are repeated in a variety of
additional CDC guidelines for specific categories of healthcare
settings (e.g., nursing homes, dental settings, assisted living
facilities, home health care settings). For example, in its guidance
for nursing homes, the CDC recommends that residents with known or
suspected COVID-19 be cared for while using all recommended PPE,
including an N95 or higher-level respirator (CDC, March 29, 2021). In
addition, in its guidance for dental settings, the CDC recommends that
dental healthcare personnel who enter the room of a patient with
suspected or confirmed COVID-19 use a NIOSH-approved N95 or equivalent
or higher-level respirator, as well as other PPE (CDC, December 4,
2020). Additionally, in its guidance for assisted living facilities,
the CDC recommends an N95 or higher-level respirator for personnel for
situations where close contact with any (symptomatic or asymptomatic)
resident cannot be avoided, if COVID-19 is suspected or confirmed in a
resident of the assisted living facility (i.e., resident reports fever
or symptoms consistent with COVID-19) (CDC, May 29, 2020). Also, in its
guidance for home healthcare settings, the CDC recommends that when
home health agency personnel are involved in the care of people with
confirmed or suspected COVID-19 at their homes, the personnel adhere to
relevant infection prevention and control practices as described in the
core healthcare guidance Interim Infection Prevention and Control
Recommendations for Healthcare Personnel During the Coronavirus Disease
2019 (COVID-19) Pandemic (i.e., that they use N95 or higher-level
respirators) (CDC, October 16, 2020).
In addition to its infection prevention and control guidelines for
healthcare personnel in healthcare settings, the CDC has issued
infection prevention and control guidelines for conducting postmortem
procedures on decedents/
human remains during the COVID-19 pandemic in Collection and Submission
of Postmortem Specimens from Deceased Persons with Confirmed or
Suspected COVID-19 (CDC, December 2, 2020). In this guidance, the CDC
recommends respirators while conducting autopsies on decedents in all
cases due to the likelihood of aerosol generation during the
performance of autopsies (CDC, December 2, 2020). The WHO has also
issued guidelines for COVID-19 infection control for aerosol-generating
procedures during autopsies. For example, WHO recommends respirators
for procedures such as the use of power saws (WHO, September 4, 2020).
As supported by the above evidence and guidance from authoritative
bodies, OSHA has concluded that healthcare employees have a heightened
risk of COVID-19 infection when working with patients with known or
suspected COVID-19. Accordingly, in any healthcare setting where
employees are exposed to patients with known or suspected COVID-19,
whether or not AGPs are performed, employers are required to provide
N95s or higher-level respirators and follow all requirements under 29
CFR 1910.134, including medical evaluations and fit testing.
III. Applicability of the Respiratory Protection Standard to COVID-19
OSHA's Respiratory Protection standard (29 CFR 1910.134) has
general requirements for respiratory protection for workers exposed to
respiratory hazards, including the COVID-19 virus. In the context of
the pandemic, the agency has applied the Respiratory Protection
standard to situations in healthcare settings where workers are exposed
to suspected or confirmed sources of COVID-19. OSHA's Respiratory
Protection standard has been in effect since 1998 and the purpose of
those controls have been established for decades (63 FR 1152, January
8, 1998). The standard contains requirements for the administration of
a respiratory protection program, with worksite-specific procedures,
respirator selection, employee training, fit testing, medical
evaluation, respirator use, respirator cleaning, maintenance, and
repair, among other requirements. It is important to note that the
standard applies to ``biological hazards'' (63 FR 1180, January 8,
1998). Accordingly, the agency will continue to apply the Respiratory
Protection standard to work tasks and situations in healthcare as
covered by 29 CFR 1910.502.
IV. Respirator Provisions Tailored to the COVID-19 Pandemic Will
Clarify Employer Responsibilities
Notwithstanding the applicability of the Respiratory Protection
standard, as OSHA will explain in this discussion, it is imperative
that the ETS contain additional provisions related to the employer's
discretion to select respirators beyond what is required by 29 CFR
1910.134. These additional requirements are necessary in order to
appropriately protect workers in healthcare industries. In the Need for
the ETS (Section IV.B. of the preamble), OSHA has addressed why
existing standards in general are inadequate to address the COVID-19
hazard. In this discussion the agency focuses more specifically on how
clarifications regarding respirator need and use will help address
COVID-19 hazards.
Many employers are confused as to when respiratory protection is
required for protection against COVID-19, leaving many unprotected
healthcare workers at high risk of becoming infected with COVID-19.
This confusion has been exacerbated by two factors. First, many
employers that need to provide respirators to protect their workers
from COVID-19 have never needed to provide respirators to their workers
in the past (e.g., many employers in the home health care or nursing
home sector), or have not had to routinely provide respirators to
certain workers in their facilities to protect them against infectious
disease hazards (e.g., the housekeeping or facilities maintenance staff
in some medical facilities). Second, there have been respirator and fit
testing supply shortages and a widespread misinterpretation by
employers of OSHA's temporary enforcement memoranda on respiratory
protection. One issue of great concern to the agency is a
misunderstanding by employers about crisis capacity strategies, which
were initially suggested by the CDC as a means to optimize supplies of
disposable N95 FFRs in healthcare settings when the alternative would
be no respiratory protection at all. Many workers report that their
employers have employed crisis capacity strategies as the de facto
daily practice, even when additional respirators were available for
use. To address these issues, the ETS contains clear mandates on when
respiratory protection is required for protection against COVID-19 and
contains a note encouraging employers to use elastomeric respirators or
PAPRs instead of filtering facepiece respirators to prevent shortages
and supply chain disruption.
To address initial N95 FFR shortages, the CDC began to create and
issue a series of strategies to optimize supplies of disposable N95
FFRs in healthcare settings when there is limited supply (CDC, April 9,
2021a). The strategies are based on the three general strata that have
been used to describe surge capacity to prioritize measures to conserve
N95 FFR supplies along the continuum of care (Hick et al., June 1,
2009). Contingency measures (temporary measures during expected N95
shortages), and then crisis capacity measures (emergency strategies
during known shortages that are not commensurate with U.S. standards of
care), augment conventional capacity measures and are meant to be
considered and implemented sequentially. However, as the supply of
respirators for healthcare personnel has increased, the CDC and FDA
have encouraged employers to transition away from the most extreme
measures of respirator conservation, crisis and contingency capacity
strategies, to conventional use (FDA, April 9, 2021; CDC, April 9,
2021a). The use of crisis capacity strategies is likely to increase the
risk of COVID-19 exposure when compared to conventional and contingency
capacity strategies.
The CDC's conventional capacity strategies for optimizing the
supply of N95 FFRs, which the CDC recommends be incorporated into
everyday practices, include a variety of measures, such as training on
use and indications for the use of respirators, just-in-time fit
testing, limiting respirators during training, qualitative fit testing,
and the use of alternatives to FFRs. CDC's conventional capacity
strategy recommendation is to use NIOSH-approved alternatives to N95
FFRs where feasible. These include other classes of disposable FFRs,
reusable elastomeric half-mask and full facepiece air-purifying
respirators, and reusable powered air-purifying respirators (PAPRs).
All of these alternatives provide equivalent or higher-level protection
than N95 FFRs when properly worn. To assist employers in this effort,
NIOSH maintains a searchable, online Certified Equipment List
identifying all NIOSH-approved respirators (NIOSH, n.d., retrieved on
January 11, 2021). Since they are reusable, elastomeric respirators and
PAPRs have the added advantage of being able to be disinfected,
cleaned, and reused according to manufacturers' instructions. As such,
they can be used by workers after the COVID-19 pandemic and during
future pandemics that may again create N95 FFR
shortages. Consistent with this, the ETS provides in a note that, where
possible, employers are encouraged to select elastomeric respirators or
PAPRs instead of filtering facepiece respirators to prevent shortages
and supply chain disruption.
Also consistent with this, the ETS provides in the same note that,
when there is a limited supply of filtering facepiece respirators (and
only when there is a limited supply of filtering facepiece
respirators), employers may follow the CDC's Strategies for Optimizing
the Supply of N95 Respirators (April 9, 2021a). This may include the
use of respirators beyond the manufacturer-designated shelf life for
healthcare delivery; use of respirators approved under standards used
in other countries that are similar to NIOSH-approved N95 respirators;
limited re-use of N95 FFRs; and prioritizing the use of N95 respirators
and facemasks by activity type. However, again, the FDA and CDC are
recommending healthcare personnel and facilities transition away from
crisis capacity conservation strategies, such as decontaminating or
bioburden reducing disposable respirators for reuse, due to the
increased domestic supply of new respirators. The FDA and CDC believe
there is an increased supply of respirators to transition away from
these strategies (FDA, April 9, 2021; CDC, April 9, 2021a).
OSHA notes finally that its enforcement of the Respiratory
Protection standard has been complicated by the respirator and fit-
testing supply shortages incurred during the pandemic. In response to
these shortages, the agency issued numerous temporary enforcement
guidance memoranda allowing its Compliance Safety and Health Officers
(CSHOs) to exercise enforcement discretion when considering issuing
citations under the Respiratory Protection standard and/or the
equivalent respiratory protection provisions of other health standards
during the pandemic (OSHA, n.d., Retrieved December 22, 2020). OSHA's
temporary enforcement memoranda are aligned with CDC's Strategies for
Optimizing the Supply of N95 Respirators, which recommend a variety of
conventional, contingency, and crisis capacity control strategies, as
mentioned above (CDC, April 9, 2021a). Unfortunately, these memoranda
have been widely misinterpreted by employers, resulting in additional
confusion about OSHA's respiratory protection requirements during the
pandemic. OSHA bases this conclusion on staff expertise and experience,
as well as on reporting in news media articles (Safety + Health, April
9, 2020; Bailey and Martin, March 19, 2020). (See also Need for the ETS
(Section IV.B. of the preamble).) For example, employers have
misinterpreted the temporary enforcement guidance memoranda as offering
blanket waivers or exemptions for complying with certain provisions of
the Respiratory Protection standard (e.g., annual fit-testing
requirements). In addition, many employers did not understand that
these memoranda allow for enforcement discretion by CSHOs only in
circumstances where an employer can demonstrate that it made
unsuccessful but objectively reasonable efforts to obtain and conserve
supplies of FFRs and fit-testing supplies. While the memoranda were
intended as guidelines for CSHOs, employer misinterpretation of these
memoranda has resulted in fewer protections for workers, particularly
in healthcare industries.
OSHA is therefore clarifying that respirators are required for the
protection of workers exposed to suspected or confirmed sources of
COVID-19 in healthcare settings, and in all of those cases the
respirators must be used in accordance with the Respiratory Protection
standard (29 CFR 1910.134). OSHA also encourages employers, where
possible, to select elastomeric respirators or PAPRs instead of
filtering facepiece respirators to prevent shortages and supply chain
disruption. Because the crisis capacity strategy is less protective,
the employer should only use crisis capacity strategies for a limited
period of time and take immediate steps to purchase and use elastomeric
respirators or PAPRs in order to prevent future shortages and further
expose their workers to the grave danger of COVID-19.
V. Conclusion
The best available evidence demonstrates that respirator use is an
important means of reducing the likelihood of COVID-19 infection of the
wearer when used in accordance with Sec. 1910.134. Respirators are
necessary controls that provide some protection to healthcare workers
and healthcare support service workers when exposed to persons with
known or suspected COVID-19.
Based on the above analysis, the agency concludes that it is
necessary to add into the ETS respiratory protection requirements
tailored specifically to the COVID-19 pandemic. These requirements will
assist employers in identifying when respiratory protection is required
for healthcare workers and will help address and strengthen worker
protection during the pandemic. To this end, the ETS takes a
prioritization approach to the conservation of respirators by requiring
the use of respirators only where airborne transmission is the most
likely (when employees are exposed to persons with suspected or
confirmed COVID-19, or in accordance with Standard and Transmission-
Based Precautions in healthcare settings).
The increased certainty associated with the respirator requirements
in the healthcare section and added flexibility of allowing employers
to follow 29 CFR 1910.504 in some limited circumstances will lead to
more compliance, and more compliance will lead to improved protection
of workers. In addition, a note in the ETS will better inform employers
that they can consider selecting from other NIOSH-approved respirator
options (i.e., elastomeric respirators and PAPRs) as alternatives to
N95 FFRs for protection against COVID-19, as well as other respiratory
infections (e.g., tuberculosis, varicella, etc.) both during the
pandemic and beyond. Knowledge of alternative respiratory protection
options for healthcare employers to consider will help them choose
appropriate alternative respirators and help mitigate respirator supply
shortages.
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Interim Infection Prevention and Control Recommendations to Prevent
SARS-CoV-2 Spread in Nursing Homes. https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html. (CDC, March 29, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, April 9).
Strategies for optimizing the supply of N95 respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html. (CDC, April 9, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, April 9).
Personal Protective Equipment: Questions and Answers. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html. (CDC,
April 9, 2021b).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Food and Drug Administration (FDA). (2021, April 9). FDA Recommends
Transition from Use of Decontaminated Disposable Respirators--Letter
to Health Care Personnel and Facilities. https://www.fda.gov/medical-devices/letters-health-care-providers/fda-recommends-transition-use-decontaminated-disposable-respirators-letter-health-care-personnel-and. (FDA, April 9, 2021).
Hick, J. et al., (2009, June 1). Refining surge capacity:
Conventional, contingency, and crisis capacity. Disaster Medicine
and Public Health Preparedness, 3(2 Suppl), S59-S67. https://doi.org/10.1097/DMP.0b013e31819f1ae2. (Hick et al., June 1, 2009).
Klompas, M. et al., (2021). A SARS-CoV-2 cluster in an acute care
hospital. Annals of Internal Medicine. [Epub ahead of print 9
February 2021] https://doi.org/10.7326/M20-7567. (Klompas et al.,
February 9, 2021).
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air of a hospital room with COVID-19 patients. International Journal
of Infectious Diseases, 100, 476-482. doi: 10.1016/
j.ijid.2020.09.025. (Lednicky et al., September 11, 2020).
National Institute for Occupational Safety and Health (NIOSH) (2020,
December). Filtering facepiece respirators with an exhalation valve:
Measurements of filtration efficiency to evaluate their potential
for source control. By Portnoff, L., Schall, J., Brannen, J., Suhon,
N., Strickland, K., Meyers, J. DHHS (NIOSH) Publication No. 2021-
107. https://www.cdc.gov/niosh/docs/2021-107/pdfs/2021-107.pdf?id=10.26616/NIOSHPUB2021107. Retrieved January 10, 2021.
(NIOSH, December, 2020).
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(n.d.) Certified equipment lists. Retrieved January 11, 2021 from
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(NIOSH, n.d., Retrieved January 11, 2021).
Occupational Safety and Health Administration (OSHA). (n.d.). COVID-
19--regulations--enforcement memoranda. Retrieved December 22, 2020
from https://www.osha.gov/coronavirus/standards#temp_enforcement_guidance. (OSHA, n.d., Retrieved December
22, 2020).
Safety + Health. (2020, April 9). OSHA allowing all employers to
suspend annual respirator fit testing. https://www.safetyandhealthmagazine.com/articles/19685-osha-allowing-all-employers-to-suspend-annual-respirator-fit-testing. (Safety +
Health, April 9, 2020).
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prevention and control for the safe management of a dead body in the
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2020).
G. Mini Respiratory Protection Program
I. Introduction
OSHA emphasizes that when respirators are required under the ETS to
protect employees against exposure to suspected or confirmed sources of
COVID-19, they must be used in accordance with the Respiratory
Protection standard (29 CFR 1910.134). Moreover, nothing in the ETS
changes an employer's obligation to identify hazards or provide a
respirator that must be used in accordance with the Respiratory
Protection standard for any other workplace hazard that might require
respiratory protection (e.g., silica, asbestos, airborne infectious
agents such as Mycobacterium tuberculosis).
OSHA's Respiratory Protection standard requires employers to
develop and implement a comprehensive written respiratory protection
program, required worksite-specific procedures and elements that
include, but are not limited to, respirator selection and use, medical
evaluation, fit testing, respirator maintenance and care, and training.
Establishing such a program can take time to establish and require a
level of expertise that some employers do not have, particularly if
they are a covered healthcare employer that did not typically have
respiratory hazards before COVID-19 (e.g., many employers in the home
health care or nursing home sector). In such cases, these regulatory
requirements may have unintentionally prevented employers from
providing their employees with a higher level of respiratory protection
than afforded by a facemask in circumstances where it may have been
beneficial to do so.
The ``mini respiratory protection program'' section of the ETS (29
CFR 1910.504) is designed to strengthen employee protections with a
small set of provisions for the safe use of respirators designed to be
easier and faster to implement than the more comprehensive respiratory
protection program. The ETS is addressing an emergency health crisis,
so it is critical for employers to be able to get more employee
protection in place quickly. OSHA expects that this approach will
facilitate additional employee choice for the additional protection
provided by respirators while reducing disincentives that may have
discouraged employers from allowing or voluntarily providing
respirators. A mini respirator program is therefore an important
control to protect employees from the hazard posed by COVID-19.
The mini respiratory protection program section is primarily
intended to be used for addressing circumstances where employees are
not exposed to suspected or confirmed sources of COVID-19, but where
respirator use could offer enhanced protection to employees. Examples
include when a respirator could offer enhanced protection in
circumstances where a less protective (in terms of filtering and fit)
facemask is required under the ETS. (See 29 CFR 1910.502(f)(4).) The
decision to use a respirator in place of a facemask could be due to the
higher filter efficiency and better sealing characteristics of
respirators when compared to facemasks and/or in consideration of an
employer's determination during their hazard assessment of constraints
on their
ability to implement other ETS provisions (e.g., physical distancing
and barriers).
If an employee uses a respirator in place of a facemask, then the
employer must ensure that the respirator is used in accordance with the
mini respiratory protection program section of the ETS or in accordance
with the Respiratory Protection standard. For example, if an employee
that is required to wear a facemask instead chooses to wear a
respirator when performing an aerosol-generating procedure (AGP) on a
patient who is not suspected or confirmed with COVID-19, the ETS only
requires the employer to ensure that the respirator is used in
accordance with the mini respiratory protection program section, rather
than in accordance with the Respiratory Protection standard, because
there is no exposure to a suspected or confirmed source of COVID-19
(see 29 CFR 1901.502(f)(4)(ii)). In contrast, employees performing AGPs
on patients with suspected or confirmed COVID-19 must be provided with
respirators that are used in accordance with the Respiratory Protection
standard (see 29 CFR 1901.502(f)(3)(i)). Additionally, employers will
still be obligated to provide a respirator that is used in accordance
with the Respiratory Protection standard for any AGPs performed on
patients suspected or confirmed with an airborne disease, such as
tuberculosis or measles.
II. Experience From the Respiratory Protection Standard (29 CFR
1910.134)
In determining the need for a mini respiratory protection program
section, the agency considered its experience with the existing
Respiratory Protection standard. While the majority of the Respiratory
Protection standard pertains to the use of respirators that are
required for the protection of employees against airborne hazards,
there is one provision allowing, but not requiring, employers to permit
employees to wear respirators in situations where respirators are not
required for protection against airborne hazards. (See 29 CFR
1910.134(c)(2).) In establishing the requirements of this provision of
the Respiratory Protection standard, OSHA also establishes some general
concepts to guide respirator use. These concepts include: (1) That the
respirator use will not in itself create a hazard; (2) that the
employer provides the respirator user with information about the safe
use and limitations of respirators; and (3) that the respirator is
cleaned, stored, and maintained so that its use does not present a
health hazard to the user. (29 CFR 1910.134(c)(2)(i) and (ii)).
OSHA has historically imposed a different set of requirements on
employers for when respirators are required to protect employees from
airborne hazards as compared to when they are not required for
protection against airborne hazards but are instead used voluntarily by
employees. More specifically, paragraph (c)(1) of the Respiratory
Protection standard requires employers to develop and implement a
comprehensive written respiratory protection program with required
worksite-specific procedures and elements whenever respirator use is
required by the standard. As noted earlier, these elements include, but
are not limited to, respirator selection and use, medical evaluation,
fit testing, respirator maintenance and care, and training. In
contrast, paragraph (c)(2) of the Respiratory Protection standard
requires employers to implement only a subset of these elements for the
voluntary use of respirators, greatly reducing the obligations of
employers who allow their employees to use respirators when such use is
not required for employee protection. In the 1998 rulemaking, OSHA
determined that paragraph (c)(2) is necessary because the use of
respirators may itself present a health hazard to employees who are not
medically able to wear them, who do not have adequate information to
use and care for respirators properly, and who do not understand the
limitations of respirators. Paragraph (c)(2) is intended to allow
employers flexibility to permit employees to use respirators in
situations where the employees wish to do so, without imposing the
burden of implementing an entire respirator program. At the same time,
it will help ensure that such use does not create an additional hazard
and that employees are provided with enough information to use and care
for their respirators properly (63 FR 1190, January 8, 1998).
The vast majority of voluntary respirator use situations under the
Respiratory Protection standard have historically involved the use of
FFRs, worn merely for an employee's comfort (63 FR 1190, January 8,
1998). Examples include employees who have seasonal allergies
requesting a FFR for comfort when working outdoors and employees
requesting a FFR for comfort while sweeping a dusty floor (63 FR 1190,
January 8, 1998). In contrast, respirator use situations under this
section of the ETS will involve employers who provide a respirator or
employees who want to wear a respirator, out of an abundance of
caution, as enhanced protection against COVID-19. They may also opt to
wear respirators other than FFRs (e.g., elastomeric respirators,
PAPRs), particularly given the supply shortages of N95 FFRs experienced
during the COVID-19 pandemic. Thus, the circumstances of respirator use
in the ETS are not merely to accommodate individual conditions or
comfort, but rather in recognition of some increased risk due to
asymptomatic and pre-symptomatic transmission of COVID-19 that is not
expected to rise to the level where respirators are required for
exposure to suspected or confirmed sources of COVID-19.
OSHA emphasizes that while the new set of requirements for
respirator use under the ETS differ in some aspects from those
specified under the Respiratory Protection standard, their intent
remains the same; that is, employers who provide respirators at the
request of their employees or who allow their employees to bring their
own respirators into the workplace must ensure that the respirator used
does not present a hazard to the health of the employee.
In the 1998 rulemaking, OSHA concluded in the rare case where an
employee is voluntarily using other than a filtering facepiece (dust
mask) respirator (paragraph (c)(2)(ii)), the employer must implement
some of the elements of a respiratory protection program, e.g., the
medical evaluation component of the program and, if the respirator is
to be reworn, the cleaning, maintenance, and storage components. An
exception to this paragraph makes clear that, where voluntary
respirator use involves only filtering facepieces (dust masks), the
employer is not required to implement a written program. While medical
evaluation is required when employees are voluntarily wearing
respirators other than FFRs under the Respiratory Protection standard,
there are no requirements under the ETS to provide medical evaluations
for employees wearing such respirators. The agency concludes that it
would be too onerous and costly for employers to provide medical
evaluations to employees wearing elastomeric respirators or PAPRs in
place of FFRs used in accordance with crisis capacity strategies during
the short period of the ETS. However, OSHA's experience with its
Respiratory Protection standard suggests that respiratory protection
can still be effective even when subject to particular safety
provisions, but not subject to the full range of requirements. In place
of medical evaluations, the agency has included a training requirement
on how to recognize medical signs and symptoms that may
limit or prevent the effective use of employer-provided respirators and
what to do if the employee experiences signs and symptoms (29 CFR
1910.504(d)(1)(v)), as well as a requirement for the discontinuation of
employer-provided respirator use (see 29 CFR 1910.504(d)(4)). This
requirement mandates that employees who wear employer-provided
respirators must discontinue respirator use when the employer or
supervisor reports medical signs or symptoms that are related to their
ability to use a respirator. In addition, any employee who previously
had a medical evaluation and was determined to not be medically fit to
wear a respirator should not be provided with an employer-provided
respirator under the ETS.
The ETS does not require employers to include any of the use
requirements specified under the ETS into a written respiratory
protection program. OSHA concludes that it would be too onerous for
employers to incorporate these requirements into a written respiratory
protection program during the short period of the ETS, particularly for
those employers who have no need to have a written respiratory
protection program in place for required respirator use. OSHA
reemphasizes that the intent of the requirements in the mini
respiratory protection program are to ensure that employees are
provided with information to safely wear respirators, without imposing
the burden of additional requirements for a written respiratory
protection program on employers.
OSHA notes that unlike the voluntary use requirements specified
under the Respiratory Protection standard, there are different
requirements for the use of employee-provided respirators as compared
to those for employer-provided respirators under the mini respiratory
protection program section. This is because the agency is requiring
employers to permit the use of employee-provided respirators. OSHA
concludes that it is necessary to permit employees to wear their own
respirators in healthcare settings given the risk for asymptomatic and
pre-symptomatic transmission and the nature of much of the work that
precludes such control measures as physical distancing and barriers.
However, the agency concludes that it would be too onerous to mandate
as many requirements for such use as are mandated when employers are
given the option of whether or not to provide employees with
respirators for use.
III. Requirements for Employee-Provided Respirators
In the 1998 rulemaking, OSHA determined that complete training is
not required for employees using respirators voluntarily; instead, the
final rule required employers to provide the information contained in
Appendix D to the Respiratory Protection standard, entitled
``Information for Employees Using Respirators When Not Required Under
the Standard,'' to ensure that employees are informed of proper
respirator use and the limitations of respirators (63 FR 1190-1192,
January 8, 1998). Under the ETS, there is only one requirement for the
use of employee-provided respirators. This requirement is for the
employer to provide these employees with a specific notice, as
specified under paragraph (c) of the mini respiratory protection
program section. This notice is almost identical to the notice
contained in Appendix D to the Respiratory Protection standard, with
some minor changes intended only to tailor the information to the
situational needs of the COVID-19 pandemic.
IV. Requirements for Employer-Provided Respirators
As noted above, under the ETS, the requirements for the use of
employer-provided respirators are more expansive under the mini
respiratory protection program section than the requirements for
employee-provided respirators. However, OSHA notes that employers are
not obligated by the ETS to provide employees with respirators for use
under the mini respiratory protection program section, so these
requirements are only mandated when an employer voluntarily provides
employees with respirators for use under the mini program. The
requirements include provisions pertaining to training, user seal
checks, reuse of respirators, and discontinuing use of respirators.
When employers choose to provide respirators to employees, the same
rationale applies as it did in the 1998 rulemaking requiring employers
to undertake these minimal obligations when they allow voluntary
respirator use is consistent with the fact that employers control the
working conditions of employees and are therefore responsible for
developing procedures designed to protect the health and safety of the
employees. Employers routinely develop and enforce rules and
requirements for employees to follow based on considerations of safety.
For example, although an employer allows employees discretion in the
types of clothing that may be worn on site, the employer would prohibit
the wearing of loose clothing in areas where clothing could get caught
in machinery, or prohibit the use of sleeveless shirts where there is a
potential for skin contact with hazardous materials. Similarly, if an
employer determines that improper or inappropriate respirator use
presents a hazard to the wearer, OSHA finds that the employer must
exert control over such respirator use and take steps to see that
respirators are safely used under an appropriate program (63 FR 1190-
1191, January 8, 1998).
The training requirements for the use of employer-provided
respirators expand on the basic respirator awareness notice required
for the use of employee-provided respirators. They require the employer
to provide training on: (a) How to inspect, put on and remove, and use
a respirator; (b) the limitations and capabilities of the respirator,
particularly when the respirator has not been fit tested; (c)
procedures and schedules for storing, maintaining, and inspecting
respirators; (d) how to perform a user seal check as described in
paragraph (e) of this section; and (e) how to recognize medical signs
and symptoms that may limit or prevent the effective use of respirators
and what to do if the employee experiences signs and symptoms. These
training requirements for respirator use are similar to the training
requirements mandated under the Respiratory Protection standard for
required respirator use. (See 29 CFR 1910.134(k)). OSHA concludes that
more extensive training provisions are required for the use of
employer-supplied respirators under the ETS because such use is likely
to be based on other factors related to the risk of COVID-19, including
the ability to implement other control measure (e.g., physical
distancing and barriers).
The user seal check requirements mandate employers to ensure that
employees conduct user seal checks and to ensure the employees correct
any problems discovered during the user seal check. This is similar to
the user seal check provision for required respirator use under the
Respiratory Protection standard. (See 1910.134(g)(1)(iii)). OSHA
concludes that ensuring that user seal checks are conducted is
necessary because employees who wear respirators are not required to be
fit tested under the ETS. OSHA notes that, in the 1998 rulemaking, OSHA
concluded that user seal checks are important in assuring that
respirators are functioning properly, and that although user seal
checks are not as objective a measure of facepiece leakage as a fit
test, they do
provide a quick and easy means of determining that a respirator is
seated properly (63 FR 1239-40, January 8, 1998). Given that employees
who choose to wear employer-provided respirators will likely be doing
so out of an abundance of caution to protect against potential airborne
transmission of SARS-CoV-2 and will not be fit tested, OSHA concludes
that it is necessary for employers to train employees how to conduct a
user seal check and to ensure that they are performed properly in order
to improve the effectiveness of the respirator.
In the 1998 rulemaking, OSHA determined that ``if the respirators
being used voluntarily are reused, it is necessary to ensure that they
are maintained in proper condition to ensure that the employee is not
exposed to any contaminants that may be present in the facepiece, and
to prevent skin irritation and dermatitis associated with the use of a
respirator that has not been cleaned or disinfected'' (63 FR 1190,
January 8, 1998). To this end, and given the potential for supply
shortages of FFRs necessitating their reuse under certain circumstances
during the COVID-19 pandemic, OSHA concludes that it is necessary to
add specific requirements for the reuse of respirators used
voluntarily. These requirements incorporate some CDC recommendations
for the reuse of FFRs used in accordance with crisis capacity
strategies (CDC, April 9, 2021).
References
Centers for Disease Control and Prevention (CDC). (2021, April 9).
Strategies for Optimizing the Supply of N95 Respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html. (CDC, April 9, 2021).
H. Aerosol-Generating Procedures on Persons With Suspected or Confirmed
COVID-19
As explained in more detail in Grave Danger (Section IV.A. of the
preamble), aerosol-generating procedures (AGP) are well-known to be
high-risk activities for exposure to respiratory infections. Workers in
a wide range of settings, such as emergency responders, healthcare
providers, and medical examiners performing autopsies, are at risk
during AGPs. For the purposes of the ETS, only the following procedures
are considered AGPs: Open suctioning of airways, sputum induction,
cardiopulmonary resuscitation, endotracheal intubation and extubation,
non-invasive ventilation (e.g., BiPAP, CPAP), bronchoscopy, manual
ventilation, medical/surgical/postmortem procedures using oscillating
bone saws, and dental procedures involving ultrasonic scalers, high-
speed dental handpieces, air/water syringes, air polishing, and air
abrasion. For further information on why these procedures are
considered AGPs under the ETS, please see the discussion of aerosol-
generating procedures in Section VIII, Summary and Explanation.
The CDC provides extensive guidance for performance of AGPs (CDC,
February 23, 2021). First, exposure should be limited where possible.
The CDC recommends that the use of procedures or techniques that might
produce infectious aerosols should be minimized when feasible, as
should the number of people in the room.
CAP has also recognized the risks involved in conducting AGPs by
recommending limiting the use of aerosol-generating tools, such as
oscillating bone saws, during autopsies on COVID-19-positive cases
(College of American Pathologists, February 2, 2021). Post-mortem
procedures using oscillating bone saws have specifically been noted as
a COVID-19-related exposure concern (Nolte et al., December 14, 2020).
The following controls are therefore recommended for autopsies
involving the use of oscillating bone saws: Isolation rooms, limiting
the number of people in the room who are exposed, negative pressure
ventilation, adequate air exchange, double door access, and use of
respirators.
As noted in Grave Danger (Section IV.A. of the preamble), it is
well-accepted that COVID-19 may spread through infectious aerosols
during AGPs. Therefore, where these procedures must be performed, there
are two important controls for these situations: Ventilation (for
example, in the form of air infection isolation rooms (AIIR), if
available) and respiratory protection. Both of these controls are
required for AGPs in the ETS. For more information on why there is a
need to include in this ETS a requirement for respirators during
aerosol-generating procedures, please see Need for Specific Provisions
(Section V of this preamble) on Respirators.
It is well-established that insufficient ventilation increases the
risk of airborne disease transmission; indeed, this is the foundation
for the World Health Organization recommendations on ventilation in
healthcare settings (Atkinson et al., 2009). When air is stagnant or
poorly ventilated, aerosols may increase in concentration and increase
exposure. Both a lack of ventilation and inadequate ventilation are
associated with increased infection rates of airborne diseases.
Increasing ventilation rates has been shown to decrease transmission
risk of airborne disease. Ventilation is able to direct airflow away
from uninfected individuals, which reduces risk of transmission.
The American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE) is the authoritative organization for ventilation
standards in the U.S. The U.S. Army Corps of Engineers (USACE) has been
tasked by the U.S. Federal Emergency Management Agency with the design
and construction of alternative care sites during surges in the COVID-
19 pandemic. USACE requested that ASHRAE provide engineering guidance
for ventilation within alternative care sites. The resulting joint
ASHRAE/USACE document makes recommendations for removal of aerosols
generated by patients during AGPs and other patient care activities in
alternative care sites (ASHRAE and USACE. November 20, 2020).
Additionally, ASHRAE provides specific guidance on source control and
AIIRs related to aerosol-generating procedures during the COVID-19
pandemic (ASHRAE, January 30, 2021).
Airborne infection isolation rooms (AIIR) are specifically designed
to control the spread of aerosols and prevent airborne transmission of
disease (Sehulster and Chinn, June 6, 2003). An AIIR has negative
pressure in comparison to accessible areas outside the room, which
causes air to flow into (rather than out of) the room from the room's
access points when they are open (e.g., an open door). When the access
points (e.g., the door) are closed and ventilation is adequate,
contaminated air cannot escape at all into the rest of the facility.
Air exhaust can be delivered directly outdoors or passed through a
special high-efficiency (HEPA) filter. In this way, AIIRs minimize
potentially contaminated air flow outward into the rest of the
facility.
Because of the risk of airborne transmission, the CDC recommends
the use of AIIRs when AGPs are performed on patients with suspected or
confirmed COVID-19. However, increased protection for workers
performing AGPs is not a new recommendation solely for the COVID-19
pandemic. The CDC and WHO both routinely recommend higher levels of
personal protective equipment for workers performing these procedures
on patients with other respiratory infections (CDC, October 30, 2018).
The CDC recommendations for AGPs performed on influenza patients
specify use of AIIRs when feasible. The
recommendations also specify that the use of portable HEPA filtration
units to further reduce the concentration of contaminants in the air
should be considered. Similarly, the World Health Organization
recommends more protective respirators for AGPs (WHO, April, 2008).
Finally, the National Institute for Occupational Safety and Health
(NIOSH) has developed a ventilated headboard that can be used to reduce
employee exposure to patient-generated aerosols containing respiratory
pathogens (NIOSH, May 26, 2020).
References
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE). (2021, January 30). Guide to the COVID-19 Pages.
https://www.ashrae.org/technical-resources/healthcare. (ASHRAE,
January 30, 2021).
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE) and United States Army Corps of Engineers
(USACE). (2020, November 20). Alternate Care Site HVAC Guidebook.
https://www.ashrae.org/about/news/2020/new-alternative-care-site-guidebook-available-to-help-respond-to-the-rising-need-for-hospital-beds-due-to-covid-19. (ASHRAE and USACE, November 20, 2020).
Atkinson, J et al., (2009). Natural Ventilation for Infection
Control in Health-Care Setting World Health Organization Guidelines.
https://www.who.int/water_sanitation_health/publications/natural_ventilation/en/. (Atkinson et al., 2009).
Centers for Disease Control and Prevention (CDC). (2018, October
30). Prevention strategies for seasonal influenza in healthcare
settings. https://www.cdc.gov/flu/professionals/infectioncontrol/healthcaresettings.htm. (CDC, October 30, 2018).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
College of American Pathologists. (2021, February 2). Amended COVID-
19 autopsy guideline statement from the CAP Autopsy Committee.
https://documents.cap.org/documents/COVID-Autopsy-Statement.pdf.
(College of American Pathologists, February 2, 2021).
National Institute for Occupational Safety and Health (NIOSH).
(2020, May 26). Worker protective controls--engineering controls to
reduce airborne, droplet and contact exposures during epidemic/
pandemic response. https://www.cdc.gov/niosh/topics/healthcare/engcontrolsolutions/ventilated-headboard.html. (NIOSH, May 26,
2020).
Nolte, K. et al., (2020, December 14). Design and construction of a
biosafety level-3 autopsy laboratory. Arch Path Lab Med. doi:
10.5858/arpa.2020-0644-SA. (Nolte et al., December 14, 2020).
Sehulster, L. and Chinn, R. (2003, June 6). Guidelines for
Environmental Infection Control in Health-Care Facilities. MMWR
52(RR10); 1-42. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm. (Sehulster and Chinn, June 6, 2003).
World Health Organization (WHO). (2008, April). Epidemic- and
pandemic-prone acute respiratory diseases--Infection prevention and
control in health care. https://www.who.int/csr/resources/publications/aidememoireepidemicpandemid/en/. (WHO, April, 2008).
I. Physical Distancing
The best available current scientific evidence demonstrates that
COVID-19 spreads mainly through transmission between people who are
physically near each other. The basic concept is that the majority of
respiratory droplets expelled from an infected person through talking,
coughing, breathing, or sneezing can travel a limited distance before
falling to the surface below due to gravity. Therefore, the farther a
person is away from the source of the respiratory droplets, the fewer
infectious viral particles are likely to reach that person's eyes,
nose, or mouth. The fewer infectious viral particles that reach that
person, the lower the risk of transmission. Additional explanation of
transmission is discussed in Grave Danger (Section IV.A. of the
preamble). OSHA recognizes that this is a simplification of the complex
issue of how droplets and aerosols moving through space applies to the
transmission of SARS-CoV-2. Nonetheless, the broad scientific
principles described in this preamble enable OSHA to describe to
affected employers and employees why the protective measures required
by this ETS are necessary to protect employees from exposure to the
virus.
The research described below demonstrates that a significant factor
in determining whether a healthy employee will become infected with
COVID-19 is how close that employee is to other people (e.g., co-
workers, patients, visitors, delivery people). Infected individuals can
transmit the virus to others whether or not the infected person is
experiencing symptoms, and symptoms may not be immediately noticeable,
so it is important to keep all employees distanced from other people
whether or not those other people exhibit symptoms. Symptomatic,
asymptomatic, and pre-symptomatic transmission is discussed further in
Grave Danger (Section IV.A. of the preamble). The role that physical
distancing plays in this ETS is thus to ensure that employees are
separated from other people as much as possible so as to reduce the
risk that virus-containing droplets reach employees.
Consistent with CDC guidance, OSHA defines physical distancing as
maintaining a sufficient distance between two people--generally
considered to be at least six feet of separation--such that the risk of
viral transmission through inhalation of virus-containing particles
from an infected individual is significantly reduced. OSHA is aware of
emerging scientific literature that suggests even greater distances may
be beneficial. OSHA is also aware of some literature from other
countries that suggests less than six feet may be appropriate in some
circumstances; however, based on the evidence summarized below, OSHA
believes that anything less than six feet is not sufficient to address
the level of risk established in the studies the agency has reviewed.
While it is likely that a distance of greater than six feet will result
in some lowered risk and OSHA recommends six feet as a minimum
distance, OSHA is not aware of sufficient evidence to justify mandating
a distance farther than the six feet recommended by the CDC. Physical
distancing is a critical component of infectious disease prevention
guidelines and is a key protective measure of the current COVID-19-
specific prevention recommendations from the CDC, WHO, and other public
health entities, as discussed in greater detail below (CDC and OSHA,
March 9, 2020; WHO, June 26, 2020; CalOSHA, 2020; ECDC, March 23, 2020;
PHAC, May 25, 2020).
The importance of physical distancing is evident from CDC's
guidance for determining who qualifies as close contacts of an
individual who is COVID-19 positive. People who have been in close
contact with a COVID-19-positive individual are most likely to become
infected. To become infected with COVID-19, a healthy individual
typically needs to inhale a certain amount of viral particles (i.e., an
infectious dose). The closer that healthy individual is to an infected
person emitting infectious viral particles, the greater their exposure
may be. In practice, a person generally needs to be both close enough
to an infectious person and near them long enough to inhale an
infectious dose. The CDC acknowledges the potential for inhalation at
distances greater than six feet from an infectious source, but notes
that this is less likely than at a closer distance (CDC, May 7, 2021).
This continues to support OSHA's recommendation for a minimum distance
of six feet. It is also important to note that multiple short exposures
over the course of a day can add up to a long enough period of time to
receive an infectious dose of COVID-19. Therefore, CDC's definition of
close contact is dependent on both proximity to one or more infected
people and the time period over which that proximity occurred. The CDC
defines close contact as ``someone who was within 6 feet of an infected
person for a cumulative total of 15 minutes or more over a 24-hour
period starting from 2 days before illness onset (or, for asymptomatic
patients, 2 days prior to test specimen collection) until the time the
patient is isolated'' (CDC, March 11, 2021). The CDC uses this close
contact designation to help determine contact tracing to minimize
transmission spread and to help communicate the risk of transmission to
the public.
The CDC close contact definition describes the likely context for
transmission events under most circumstances. However, it should be
noted that infections can occur from exposures of less than 15 minutes.
For example, one infection event was documented that resulted from only
roughly five minutes of exposure (Kwon et al., November 23, 2020).
Thus, distancing may reduce COVID-19 exposure during even short periods
of exposure.
The notion that physical distancing can protect a healthy
individual from respiratory droplets is well established for droplet-
transmissible diseases and has been a topic of study for well over a
hundred years (Flugge, 1897; Jennison, 1942; Duguid, November 1, 1945;
Wells, November 1, 1955). Carl Flugge (1897) is credited with
originating the concept of droplet transmission. In his study using
settling plates to collect large droplets that were emitted from an
individual, he found that droplets fell to the plates within two meters
(approximately 6.6 feet). Combining this knowledge with the known
presence of infectious materials in respiratory droplets, Flugge
suggested that remaining two meters from infected individuals would be
protective. This understanding of droplet transmission was further
expanded a few decades later, when William F. Wells noted that in
Flugge's study, Flugge was unable to observe a proportion of small
droplets that would evaporate before settling on the plates and that
these evaporated droplets traveled differently, suggesting that some
measure of transmission may happen beyond the large droplet
transmission that Flugge observed (Wells, November 1, 1934).
Subsequently, in the 1940s and 1950s, high-speed photography improved
to the point where it could capture, upon emission, most of the
respiratory droplets--large and small--that formed; this line of study
validated much of the groundwork that Flugge and Wells laid (Jennison,
1942; Duguid, November 1, 1945; Hamburger and Robertson, May 1, 1948;
Wells, November 1, 1955). These studies illustrated that large droplets
can be a major driver of disease transmission, but also that there
might be exceptions to the effectiveness of physical distancing when it
comes to virus-laden small droplets.
Even though COVID-19 is a recent disease, evidence of the
effectiveness of physical distancing in reducing exposures to SARS-CoV-
2 has been illustrated through a variety of scientific approaches,
including an experimental study by Ueki et al., (October 21, 2020), a
modeling study by Li et al., (November 3, 2020), and real world
observational studies by Chu et al., (June 27, 2020) and Doung-ngern et
al., (September 14, 2020). In a controlled laboratory experiment
performed by Ueki et al., (October 21, 2020), researchers developed a
scenario where 6 mL of SARS-CoV-2 viral serum was nebulized from a
mannequin's mouth to form a mist that simulated a cough. Another
mannequin, which was outfitted with an artificial ventilator set to an
average adult ventilation rate, collected a proportion of the mist at
distances of 0.25 meters (approximately 0.8 feet), 0.5 meters
(approximately 1.6 feet), and 1 meter (approximately 3.3 feet). Using
the 0.25-meter distance as a baseline, increasing the distance between
the mannequins reduced viral particle exposure (measured as the number
of viral RNA copies) by 62% at 0.5 meters and 77% at 1 meter. The study
clearly illustrates the increased protection from viral exposure that
results from increasing distance between individuals.
Modeling studies also provide evidence supporting the effectiveness
of physical distancing in preventing exposure to SARS-CoV-2. In Li et
al., (November 3, 2020), researchers modeled exposures resulting from
respiratory droplets dispersed from a simulated typical cough using
simulated saliva with a SARS-CoV-2 viral concentration measured from
infected individuals. The simulated cough emitted 30,558 viral copies
at distances of one meter (approximately 3.3 feet) and two meters
(approximately 6.6 feet) between the infectious person and the person
exposed. At one meter, more than 65% of the droplet volume (about
20,000 viral copies) reached the recipient. However, almost all of the
exposure was deposited below the head, with only 9 viral copies
estimated to land on the area that would normally be covered by a face
covering. When the distance was increased to two meters, 63 viral
copies landed on the recipient, with only 0.6 copies expected to hit
the face covering area. This study illustrates not only the benefit of
distance for reducing inhalation exposure, but also for reducing
contamination of clothing, which can contribute to overall exposure if
a person touches their contaminated clothing and then touches their
eyes, nose, or mouth.
Outside of experimental and modeling scenarios, observations in
real world situations also substantiate the finding that increasing
physical distance protects people from developing infections. A
systematic review of 172 studies on SARS-CoV-2 (up to early May 2020),
SARS-CoV-1 (a viral strain related to SARS-CoV-2), and Middle Eastern
Respiratory Syndrome (MERS) (a disease caused by a virus that is
similar to SARS-CoV-2 and spreads through droplet transmission) found
38 studies, containing 18,518 individuals, to use in a meta-analysis
that evaluated the effectiveness of physical distancing (Chu et al.,
June 27, 2020). The researchers compared the infection rates for
individuals who were within one meter (approximately 3.3 feet) of
infected people versus the infection rates for those who were greater
than one meter away. For individuals who were within one meter, the
chance of viral infection was 12.8%. When distance was greater than one
meter, the chance of viral infection decreased to 2.6%. Furthermore,
researchers projected that with each additional meter of distance the
risk would be reduced by an additional 2.02 times.
The importance of physical distancing even when people are not
exhibiting symptoms was further demonstrated by a COVID-19 study from
Thailand. Researchers reviewed physical distancing information
collected from 1,006 individuals who had an exposure to infected
individuals (Doung-ngern et al., September 14, 2020). At the time of
the exposure, many of the infected individuals were not yet
experiencing symptoms, and none of the exposed individuals included in
the study were experiencing symptoms. The researchers contacted the
individuals 21 days after their exposures to determine if any secondary
infections had occurred. Out of 1,006 participants, 197 tested positive
and 809 either tested
negative or were considered low risk contacts, did not exhibit symptoms
and, therefore, were not tested. The researchers then compared the
incidence of secondary infections to data on how close the exposed
individuals were to the infected individuals. Exposed individuals were
placed into three groups: Those who had direct physical contact with
the infected individual, those who were within one meter (approximately
3.3 feet) but without physical contact, and those who remained more
than one meter away. The study revealed that the group with direct
physical contact and the group within one meter but without physical
contact were equally likely to become infected with SARS-CoV-2.
However, the group that remained more than one meter away had an 85%
lower infection risk than the other two groups.
As noted earlier, there is additional nuance to droplet fate beyond
just the general effects of gravity on large droplets. Studies
evaluating the dispersion of aerosols (i.e., particles that are smaller
than typical droplets) and atypical droplets in the air have created a
more thorough understanding of disease transmission and the limitations
on the effectiveness of physical distancing (Jones et al., August 25,
2020). The distance that droplets may be able to travel depends on
their size, expelled velocity, airflow, and other environmental
considerations (Xie et al., May 29, 2007; Dbouk and Drikakis, May 1,
2020; Li et al., April 22, 2020). Bahl et al., (April 16, 2020)
reviewed ten studies on the horizontal spread of droplets, finding that
seven of the studies observed maximum distances traveled by droplets
that greatly exceeded two meters (approximately 6.6 feet); one of which
suggested the possibility of travel up to eight meters (approximately
26.2 feet). Several case studies have identified incidents where
transmission of SARS-CoV-2 occurred over distances of 15.1 feet (Li et
al., April 22, 2020), 21.3 feet (Kwon et al., November 23, 2020) and
26.2 feet (Gunther et al., October 27, 2020). These studies suggest
that while maintaining a physical distance of two meters reduces
transmission significantly, there is still some risk of transmission
beyond two meters. Thus, these studies illustrate that physical
distancing is an important control, but also why physical distancing
alone is insufficient, and a multi-layered strategy that includes
additional control measures is necessary to protect employees from
contracting COVID-19.
As demonstrated by the studies above, it is widely accepted that
physical distancing reduces transmission of infectious diseases
generally, and COVID-19 specifically. While the specific distance
needed to ensure maximum reduction of COVID-19 transmission can be
debated, six feet has long been used in the U.S. as the minimum
acceptable distance in most situations to prevent transmission of
droplet-transmissible infectious diseases, and the CDC has recommended
that distance to combat COVID-19 since the start of the pandemic (CDC
and OSHA, March 9, 2020).
Physical distancing strategies can be applied on an individual
level (e.g., avoiding coming within six feet of another individual), a
group level (e.g., canceling group activities where individuals would
be in close contact), and an operational level (e.g., promoting
telework, reconfiguring the infrastructure or reducing facility
occupancy levels to allow sufficient space for physical distancing). As
described in further detail in Summary and Explanation (Section VIII of
the preamble), CDC and OSHA have identified various approaches to
maintaining physical distance between employees, such as: Reducing the
number of employees on-site at one time; reducing facility occupancy
levels (both for employees and non-employees); staggering arrival,
break, and departure times to maintain distancing during specific times
at work when adherence is difficult; and holding on-site training or
meeting activities in larger spaces to allow for sufficient distance
between attendees (CDC and OSHA, March 9, 2020).
Physical distancing practices and recommendations are also well-
accepted internationally as an effective measure to reduce the spread
of COVID-19. The World Health Organization (WHO) recommends physical
distance of at least one meter (approximately 3.3 feet) in all
workplace settings, with a preference for two meters (approximately 6.6
feet) (WHO, June 26, 2020). WHO also recommends providing sufficient
work space of at least 10 square meters for each employee where it is
feasible based on work tasks. Some foreign governments have implemented
physical distancing requirements and recommendations varying in
distances of: One meter (e.g., Hong Kong, Singapore, United Kingdom,
Norway), 1.5 meters (e.g., Germany, Spain), and 2 meters (e.g., Japan,
South Korea, Canada) (Han et al., November 7, 2020; PHAC, May 25,
2020). While the required or recommended amount of distance varies
between jurisdictions, it is clear that physical distancing is
considered to be a critical tool in preventing the spread of COVID-19
around the world and that, even where six feet of distance cannot be
maintained, maintaining as much distance as possible can help minimize
the possibility of disease transmission (Chu et al., June 27, 2020;
Doung-ngern et al., September 14, 2020; Li et al., November 3, 2020;
Ueki et al., 2020).
Based on the best available evidence, the agency concludes that
physical distancing of at least six feet is an effective and necessary
tool to protect employees from COVID-19 by reducing incidence of COVID-
19 illness. This conclusion applies to physical distancing on its own
and also when complemented by other measures as part of a multi-layered
strategy to minimize employee exposure to COVID-19.
References
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for Health Workers Treating Coronavirus Disease 2019. The Journal of
Infectious Diseases jiaa189. https://doi.org/10.1093/infdis/jiaa189.
(Bahl et al., April 16, 2020).
California Division of Occupational Safety and Health (CalOSHA).
(2020). COVID-19 Prevention Emergency Standard. OSHSB-98(2/98).
(CalOSHA, 2020).
Centers for Disease Control and Prevention (CDC) and Occupational
Safety and Health Administration (OSHA). (2020, March 9). Guidance
on Preparing Workplaces for COVID-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (CDC and OSHA, March 9,
2020).
Centers for Disease Control and Prevention (CDC). (2021, March 11).
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(CDC, March 11, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. (CDC,
May 7, 2021).
Chu, DK et al., (2020, June 27). Physical Distancing, Face Masks,
and Eye Protection to Prevent Person-to-Person Transmission of SARS-
CoV-2 and COVID-19: a systematic review and meta-analysis. The
Lancet 395: 1973-1987. https://doi.org/10.1016/. (Chu et al., June
27, 2020).
Dbouk, T. and Drikakis, D. (2020). On Coughing and Airborne Droplet
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Doung-ngern, P. et al., (2020, September 14). Case-control Study of
Use of Personal Protective Measures and Risk for SARS Coronavirus 2
Infection, Thailand. Emerging Infectious Diseases 26, 11: 2607-2616.
https://doi.org/10.3201/
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Duguid, JP. (1945). The Numbers and the Sites of Origin of the
Droplets Expelled During Expiratory Activities. Edinburgh Medical
Journal 52, 11: 385-401. (Duguid, November 1, 1945).
European Centre for Disease Prevention and Control (ECDC). (2020,
March 23). Considerations related to social distancing measures in
response to COVID-19--second update. https://www.ecdc.europa.eu/en/publications-data/considerations-relating-social-distancing-measures-response-covid-19-second. (ECDC, March 23, 2020).
Flugge, C. (1897). Uber Luftinfection. Zeitschrift fur Hygiene und
Infektionskrankheiten 25: 179-224. (Flugge, 1897).
Gunther, T. et al., (2020, October 27). SARS-CoV-2 Outbreak
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Hamburger, M. and Robertson, OH. (1948, May 1). Expulsion of Group A
Hemolytic Streptococci in Droplets and Droplet Nuclei by Sneezing,
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(Hamburger and Robertson, May 1, 1948).
Han, E. et al., (2020, November 7). Lessons Learned from Easing
COVID-19 Restrictions: An Analysis of Countries and Regions in Asia
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Jennison, MW. (1942). Atomising of Mouth and Nose Secretions into
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Jones, NR et al., (2020, August 25). Two Metres or One: What is the
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Kwon, KS et al., (2020, November 23). Evidence of Long-Distance
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Restaurant in Korea. J Korean Med Sci 35(46): e415. https://jkms.org/DOIx.php?id=10.3346/jkms.2020.35.e415. (Kwon et al.,
November 23, 2020).
Li, H. et al., (2020, November 3). Dispersion of Evaporating Cough
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Ventilated Restaurant. PREPRINT https://doi.org/10.1101/2020.04.16.20067728. (Li, April 22, 2020).
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Ueki, H. et al., (2020, October 21). Effectiveness of Face Masks in
Preventing Airborne Transmission of SARS-CoV-2. mSphere 5: e00637-
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21, 2020).
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Droplets and Droplet Nuclei. American Journal of Epidemiology 20(3):
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Wells, WF. (1955, November 1). Airborne Contagion and Air Hygiene:
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Xie, X. et al., (2007, May 29). How far droplets can move in indoor
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May 29, 2007).
J. Physical Barriers
When people with COVID-19 cough, sneeze, sing, talk, yell, or
breathe, they produce respiratory droplets. Epidemiological research
has found that most COVID-19 transmission occurs via respiratory
droplets that are spread from an infected individual during close
(within 6 feet) person-to-person interactions (CDC, May 7, 2021; CDC,
May 13, 2021a; WHO, July 9, 2020). The amount of respiratory droplets
and particles released when a person breathes is significant, and the
amount increases when someone talks or yells (Asadi et al., February
20, 2019; Alsved et al., September 17, 2020; Abkarian et al., October
13, 2020).
Barriers can be used to minimize occupational exposure to SARS-CoV-
2. Barriers work by preventing droplets from traveling from the source
(i.e., an infected person) to an employee, thus reducing droplet
transmission. When barriers are used properly, they will intercept
respiratory droplets that may contain SARS-CoV-2. Barriers are
particularly critical when physical distancing of six feet is required
but not feasible (AIHA, September 9, 2020; Fischman and Baker, June 4,
2020; CDC, April 7, 2021; CDC, March 8, 2021; WHO, May 10, 2020;
University of Washington, October 29, 2020).
When engineering controls, such as physical barriers, are
appropriately installed and located, they can reduce exposure to
infectious agents, such as SARS-CoV-2, without relying on changes in
employee behavior (OSHA, 2009). Therefore, engineering controls are
often the most effective type of control and can also be a cost-
effective layer of protection (AIHA, September 9, 2020). Physical
barriers are not a stand-alone measure and are only one part of a
multi-layered approach for infection control. To protect employees from
exposure to SARS-CoV-2, engineering controls need to be combined with
work practice controls, administrative controls, and PPE to ensure
adequate protection (CDC, April 7, 2021; CDC, March 8, 2021).
Physical barriers, such as plastic or acrylic partitions, are well-
established and accepted as an infection control approach to containing
droplet transmissible diseases. Recommendations for the use of physical
barriers are commonly made in connection with pandemic events, such as
the 2010 pandemic influenza (see, for example, OSHA, 2009) or avian
influenza pandemics (see, for example, CDC, January 23, 2014). However,
physical barriers are recognized as effective engineering controls for
preventing the transmission of infectious agents and, therefore, have
been commonly used in other workplace settings even under non-pandemic
conditions. For instance, sneeze guards are included in the FDA's 2017
Food Code, which all 50 states use for their food safety regulations
(FDA, 2017). These barriers, typically placed in front of and above
food items, intercept contaminants, such as respiratory droplets, that
may be expelled from a person's mouth or nose (Todd et al., August 1,
2010).
Impermeable barriers intercept respiratory droplets and prevent
them from reaching another individual (Fischman and Baker, June 4,
2020; Ibrahim et al., June 1, 2020; Dehghani et al., December 22, 2020;
University of Washington, October 29, 2020). Thus, physical barriers
can be a practical solution for decreasing the transmission of
infectious viral particles for a wide range of work activities and
locations. Only barriers that keep respiratory droplets out of an
employee's breathing zone will reduce overall exposure to SARS-CoV-2.
The breathing zone is the area immediately around an individual's mouth
and nose from which a person draws air when they breathe and extends 9
inches beyond a person's nose and mouth (OSHA, February 11, 2014).
Additional considerations for the design and implementation of physical
barriers to
properly block face-to-face pathways of breathing zones, including
acceptable materials and installation, is discussed in the Summary and
Explanation (Section VIII of the preamble).
While COVID-19-related research on barriers is fairly limited due
to the recent emergence and ongoing nature of the pandemic, there is
some evidence of the effectiveness of physical barriers in healthcare
settings during the COVID-19 pandemic. Using a surrogate for SARS-CoV-
2, Mousavi et al., (August 13, 2020) designed an experimental study in
which general patient rooms in a healthcare facility were converted
into isolation rooms constructed out of plastic barriers with zipper
doors. The authors found that the use of the barrier alone could stop
the particles that contacted the barrier and prevent 80% of the
surrogate SARS-CoV-2 particles from spreading to adjacent spaces. In
contrast, without the barrier, particles were easily dispersed to other
areas of the facility. The barrier was actually more effective at
containing particles than a solid door, as the barrier did not create
changes in airflow patterns like a door does when it opens and closes.
A simulation study using a double set of plastic drapes as a
barrier around a patient's head and neck during patient intubation
found that the drapes were effective at minimizing contamination to the
healthcare provider and patient (Ibrahim et al., June 1, 2020).
Similarly, a simulation study performed in a dental healthcare setting
evaluated the use of clear, flexible barriers that were fitted over the
patient chair and covered the patient's head, neck, and chest; the
barriers had small openings for the employee's hands. The barriers were
found to reduce the number of dyed water droplets landing on the
provider and in the surrounding work environment during the dental
procedure (Teichert-Filho et al., August 18, 2020). A simulation study
of peroral endoscopy procedures performed through the mouth found that
the use of an acrylic box around a patient's head during the procedure
may reduce the number of droplets transmitted to the providers
performing the procedure (Gomi et al., October 21, 2020).
A separate group of researchers developed a simulation study in an
open work station environment to evaluate how physical barriers may
impact disease transmission. They found that physical barriers were
able to reduce the transmission of simulated 1um aerosolized particles
from a source individual to others who were over 6 feet away by 92%
(Abuhegazy et al., October 20, 2020). OSHA notes that it would be
expected that large droplets, as opposed to aerosolized particles,
would be reduced to a greater extent because they do not remain
airborne for extended periods of time unlike aerosolized particles, as
noted in the Physical Distancing section of the Need for Specific
Provisions analysis.
Researchers found that a COVID-19 outbreak among hospital food
service employees was effectively contained with the prompt
implementation of physical barriers in the workplace where physical
distancing was not implemented (Hale and Dayot, August 13, 2020). This
included installing partitions at cashier stations between employees
and non-employees, as well as in food preparation areas between
workstations (Hale and Dayot, August 13, 2020). While this evidence of
the effectiveness of barriers was not drawn from healthcare settings,
the same concept would be equally applicable to preventing transmission
between people at similarly fixed locations in healthcare facilities,
such as barriers separating a receptionist from a patient in intake or
barriers separating workers sitting side by side at desks in a
hospital's administrative office.
It is not clear, however, that barriers are necessary to separate
fully vaccinated employees from employees who are not fully vaccinated
and are not suspected or confirmed to have COVID-19. As discussed in
the Grave Danger section and in the explanation for the scope exception
in Sec. 1910.501(a)(4), the CDC has acknowledged a ``growing body'' of
evidence that vaccination can reduce the potential that a vaccinated
person will transmit the SARS-CoV-2 virus to non-vaccinated co-workers
(CDC, April 12, 2021; CDC, May 13, 2021b).
Based on the best available evidence, the agency concludes that
physical barriers are an effective and necessary means of, and play a
vital role in, reducing transmission of SARS-CoV-2 when complemented by
other measures as part of a multi-layered strategy to minimize the
risks of employee exposure to SARS-CoV-2 by employees who are not fully
vaccinated or from non-employees.
References
Abkarian, M. et al., (2020, October 13). Speech can produce jet-like
transport relevant to asymptomatic spreading of virus. PNAS 117: 41,
25237-25245. https://www.pnas.org/cgi/doi/10.1073/pnas.2012156117.
(Abkarian et al., October 13, 2020).
Abuhegazy, A. et al., (2020, October). Numerical investigation of
aerosol transport in a classroom with relevant to COVID-19. Physics
of Fluids 32, 103311. https://doi.org/10.1063/5.0029118. (Abuhegazy
et al., October 20, 2020).
Alsved, M. et al.,(2020, September 17). Exhaled respiratory
particles during singing and talking. Aerosol Science and Technology
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(Alsved et al., September 17, 2020).
American Industrial Hygiene Association (AIHA). (2020, September 9).
Reducing the Risk of COVID-19 Using Engineering Controls: Guidance
Document. https://aiha-assets.sfo2.digitaloceanspaces.com/AIHA/resources/Guidance-Documents/Reducing-the-Risk-of-COVID-19-using-Engineering-Controls-Guidance-Document.pdf. (AIHA, September 9,
2020).
Asadi, S et al., (2019, February 20). Aerosol emission and
superemission during human speech increase with voice loudness.
Scientific Reports 9: 2348. https://doi.org/10.1038/s41598-019-38808-z. (Asadi et al., February 20, 2019).
Centers for Disease Control and Prevention (CDC). (2014, January
23). Interim Guidance for Infection Control Within Healthcare
Settings When Caring for Confirmed Cases, Probable Cases, and Cases
Under Investigation for Infection with Novel Influenza A Viruses
Associated with Severe Disease. https://www.cdc.gov/flu/avianflu/novel-flu-infection-control.htm. Accessed January 28, 2021. (CDC,
January 23, 2014).
Centers for Disease Control and Prevention (CDC). (2021, April 12).
Benefits of getting a COVID-19 vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. (CDC, April
12, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. (CDC,
May 7, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, May 13).
How COVID-19 Spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 13).
Interim Public Health Recommendations for Fully Vaccinated People.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html. (CDC, May 13, 2021b).
Centers for Disease Control and Prevention (CDC). (2021, March 8).
Guidance for Businesses and Employers Responding to Coronavirus
Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html. (CDC, March 8, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 7).
COVID-19 Employer Information for Office Buildings. https://www.cdc.gov/coronavirus/2019-ncov/community/office-buildings.html.
(CDC, April 7, 2021).
Dehghani, F. et al., (2020, December 22). The hierarchy of
preventive measures to
protect workers against the COVID-19 pandemic: A review. Work 67:
771-777. DOI: 10.3233/WOR-203330. (Dehghani et al., December 22,
2020).
Fischman, ML and Baker, B. (2020, June 4). COVID-19 Resource Center.
American College of Occupational and Environmental Medicine [ACOEM].
https://acoem.org/COVID-19-Resource-Center/COVID-19-Q-A-Forum/Could-you-provide-guidance-on-the-use-of-plexiglass-barriers-for-workplaces-for-sneeze-guard%E2%80%9D-dropl. (Fischman and Baker,
June 4, 2020).
Food and Drug Administration (FDA). (2017). Food Code: 2017
Recommendations of the United States Public Health Service, Food and
Drug Administration. (FDA, 2017).
Gomi, K. et al., (2020, October 21). Peroral endoscopy during the
COVID-19 pandemic: Efficacy of the acrylic box (Endo-Splash
Protective (ESP) box) for preventing droplet transmission. Journal
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jgh3.12438. (Gomi et al., October 21, 2020).
Hale, M. and Dayot, A. (2020). Outbreak Investigation of COVID-19 in
Hospital Food Service Workers. American Journal of Infection
Control. S0196-6553(20)30777-X. https://doi.org/10.1016/j.ajic.2020.08.011. (Hale and Dayot, August 13, 2020).
Ibrahim, M. et al., (2020, June 1). Comparison of the effectiveness
of different barrier enclosure techniques in protection of
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Anesthesia and Analgesia Practice 14: 3. DOI: 10.1213/
XAA.0000000000001252. (Ibrahim et al., June 1, 2020).
Mousavi, ES et al., (2020, August 13). Performance analysis of
portable HEPA filters and temporary plastic anterooms on the spread
of surrogate coronavirus. Building and Environment 183: 107186.
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August 13, 2020).
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Occupational Safety and Health Administration (OSHA). (2014,
February 11). OSHA Technical Manual, Section II: Chapter 1--Personal
Sampling for Air Contaminants. https://www.osha.gov/dts/osta/otm/otm_ii/otm_ii_1.html. (OSHA, February 11, 2014).
Teichert-Filho, R. et al., (2020, August 18). Protective device to
reduce aerosol dispersion in dental clinics during the COVID-19
pandemic. International Endodontic Journal. doi: 10.1111/iej.13373.
(Teichert-Filho et al., August 18, 2020).
Todd, ECD et al., (2010, August 1). Outbreaks where food workers
have been implicated in the spread of foodborne disease. Part 7.
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Prevention Efforts. University of Washington Environmental Health &
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October 29, 2020).
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public health and social measures in the workplace context of COVID-
19: Annex to Considerations in adjusting public health and social
measures in the context of COVID-19, May 2020. https://www.who.int/publications-detail-redirect/considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19. (WHO,
May 10, 2020).
World Health Organization (WHO). (2020, July 9). Transmission of
SARS-CoV-2: Implications for infection prevention precautions.
https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions. (WHO,
July 9, 2020).
K. Hygiene and Cleaning
COVID-19 can also be spread through contact transmission, which
occurs when a person touches another person who has COVID-19 (e.g.,
during a handshake) or a surface or item contaminated with the virus
(e.g., workstations, shared equipment or products) and then touches
their own eyes, nose, or mouth (CDC, May 13, 2021; CDC, April 5,
2021d). Contact transmission via inanimate objects is also known as
fomite transmission. While contact transmission is less common than
droplet transmission, and the risk of infection from touching a surface
is low, contracting COVID-19 via contact transmission remains a concern
in the workplace. Contact transmission is discussed in greater detail
in Grave Danger (Section IV.A. of the preamble).
To protect against COVID-19 transmission, the CDC has recommended
cleaning and situational disinfecting of high-touch surfaces, as well
as frequent handwashing, as key prevention methods (CDC, April 5,
2021a, and CDC, May 17, 2020, respectively). Cleaning means the removal
of dirt and impurities, including germs, from surfaces using soap and
water or other cleaning agents (i.e., not Environmental Protection
Agency (EPA)-registered disinfectants). Cleaning alone reduces germs on
surfaces by removing contaminants and may also weaken or damage some of
the virus particles, which decreases risk of infection from surfaces.
Disinfection means using an EPA-registered List N disinfectant in
accordance with manufacturers' instructions to kill germs on surfaces
or objects. Disinfection further lowers the risk of spreading infection
and the CDC recommends disinfection in indoor community settings where
there has been a suspected or confirmed COVID-19 case in the previous
24 hours (CDC, April 5, 2021d).
I. Cleaning and Hand Hygiene Are Most Effective in Combination
Based on the best available evidence, OSHA has determined that
proper hand hygiene, cleaning, and situational disinfection of high-
touch surfaces and surfaces touched by someone with COVID-19 are
critical provisions of the ETS, both on their own and also when
complemented by other measures as part of a multi-layered strategy to
minimize employee exposure to this grave COVID-19 danger. Practicing
proper hand hygiene combined with routine cleaning of contact surfaces,
minimizes the risk of contracting COVID-19 through contact with
contaminated surfaces, followed by touching the mouth, nose, or eyes
(Honein et al., December 11, 2020). Cleaning surfaces removes harmful
contaminants from surfaces, reducing the risk of COVID-19 transmission
following hand contact with those surfaces. Disinfection of surfaces
and equipment in indoor community settings should be done if a
suspected or confirmed COVID-19 case was utilizing those areas within
the past 24 hours (CDC, April 5, 2021d). Cleaning, disinfection, and
hand hygiene are foundational components of Standard and Transmission-
Based Precautions for infection control and prevention (Siegel et al.,
2007).
II. Cleaning and Disinfection
Respiratory secretions or droplets expelled by infected individuals
can contaminate surfaces and objects (WHO, July 9, 2020). Evidence
suggests that the virus that causes COVID-19 may remain viable on
surfaces for hours to days (Riddell et al., October 7, 2020; van
Doremalen et al., April 16, 2020; CDC, April 5, 2021b), depending on
the ambient environment and the type of surface (WHO, July 9, 2020).
Although fomites and contaminated surfaces are not a common
transmission mode of COVID-19, demonstration of surface contamination
and experiences with surface contamination linked to subsequent
infection transmission with other coronaviruses, have informed the
development of cleaning and situational
disinfection recommendations to mitigate the potential of fomite
transmission of COVID-19 (WHO, May 14, 2020; CDC, April 5, 2021d).
Cleaning of visibly dirty surfaces is a best practice measure for
prevention of COVID-19 and other viral respiratory illnesses in all
settings, including healthcare. Disinfection of these surfaces may be
appropriate if it is reasonable to assume that individuals with COVID-
19 may have been present. Cleaning and disinfection reduces the risk of
spreading infection by removing and killing germs on surfaces people
frequently touch, and in areas that were occupied or visited by a
person confirmed to have COVID-19 (CDC, April 5, 2021a; WHO, May 14,
2020; CDC, April 5, 2021c; CDC, April 5, 2021d).
Scientific evidence and guidelines from the CDC and WHO support
cleaning and situational disinfection of surfaces as an effective
practice to prevent the transmission of infectious viruses. Human
coronaviruses, including MERS coronavirus or endemic human
coronaviruses (HCoV), can be efficiently inactivated by surface
disinfection procedures (Kampf et al., February 6, 2020). A study of
124 Beijing households with one or more laboratory-confirmed COVID-19
positive family members demonstrated the efficacy of disinfection in
preventing the transmission of COVID-19. The study found that disease
transmission to family members was 77% less with use of chlorine- or
ethanol-based disinfectants every day compared to use of disinfectants
once in two or more days, irrespective of other protective measures
taken such as mask wearing and physical distancing (Wang et al., May
11, 2020).
The World Health Organization recommends thoroughly cleaning
environmental surfaces with water and detergent and applying commonly
used hospital-level disinfectants, such as sodium hypochlorite (i.e.,
the active ingredient in chlorine bleach), for effective cleaning and
disinfection (WHO, May 14, 2020). Surface disinfection with 0.1% sodium
hypochlorite or 62-71% ethanol significantly reduces coronavirus
infectivity on surfaces within 1 minute of exposure time (Kampf et al.,
February 6, 2020). The Environmental Protection Agency (EPA) has
compiled List N, a list of disinfectant products that can be used
against the virus that causes COVID-19, including ready-to-use sprays,
concentrates, and wipes (EPA, April 9, 2021). EPA includes products on
List N if they have demonstrated efficacy against the COVID-19 virus,
or a germ that is harder to kill than SARS-CoV-2 virus, or another
human coronavirus that is similar to the SARS-CoV-2 virus (EPA,
February 17, 2021).
III. Hand Hygiene
In all settings, including settings where regular cleaning may be
difficult, frequent hand washing and avoiding touching of the face
should be considered the primary prevention approach to mitigate COVID-
19 transmission associated with surface contamination (WHO, May 14,
2020). Hand hygiene is generally recognized as an effective
intervention at preventing respiratory illnesses and infectious disease
transmission (Rabie and Curtis, March 7, 2006; Haque, July 12, 2020;
Rundle et al., July 22, 2020). The CDC and the WHO have determined that
frequent handwashing, plus sanitization, are essential control measures
for COVID-19 prevention within the workplace, and HICPAC identifies
hand hygiene as an essential element of Standard Precautions (CDC, May
17, 2020; WHO, July 9, 2020; WHO, May 14, 2020; Siegel et al., 2007).
To prevent virus transmission, the CDC recommends that healthcare
workers engage in frequent handwashing with soap and water for at least
20 seconds, or use an alcohol-based hand sanitizer with at least 60%
alcohol (CDC, May 17, 2020). Alcohol-based hand sanitizers are the most
effective products for reducing the number of germs on the hands of
healthcare providers and are the preferred method for cleaning hands in
most clinical situations, while handwashing is necessary whenever hands
are visibly soiled (CDC, January 8, 2021). Handwashing with soap and
water mechanically removes pathogens (Burton et al., January 6, 2011),
and laboratory data demonstrates that hand sanitizers that contain at
least 60% alcohol are effective at killing the virus that causes COVID-
19 (Kratzel et al., July 2020; Siddharta et al., March 15, 2017).
Experience with work settings shows that flexible hand hygiene
approaches are effective to address unique scenarios in various work
environments. For example, handwashing is usually emphasized over hand
sanitizing, but CDC recommends the use of alcohol-based hand sanitizers
as the primary method for hand hygiene in most healthcare situations
(CDC, October 14, 2020). In healthcare settings, alcohol-based hand
sanitizers with 60-95% alcohol effectively reduce the number of
pathogens that may be present on the hands of healthcare providers,
particularly after interacting with patients (CDC, May 17, 2020). In
most clinical settings, unless hands are visibly soiled, an alcohol-
based hand rub is preferred over soap and water due to evidence of
better compliance compared to soap and water. However, CDC does
recommend healthcare workers wash their hands for at least 20 seconds
with soap and water when hands are visibly dirty, before eating, and
after using the restroom (CDC, May 17, 2020). Alcohol-based hand
sanitizers are also important as an alternative to soap and water for
workers who do not have ready access to handwashing facilities (e.g.,
emergency responders).
References
Burton, M. et al., (2011, January 6). The effect of handwashing with
water or soap on bacterial contamination of hands. International
Journal of Environmental Research and Public Health, 8(1), 97-104.
https://doi.org/10.3390/ijerph8010097. (Burton et al., January 6,
2011).
Centers for Disease Control and Prevention (CDC). (2020, May 17).
Hand hygiene recommendations: Guidance for healthcare providers
about hand hygiene and COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html. (CDC, May 17, 2020).
Centers for Disease Control and Prevention (CDC). (2020, October
14). Frequent questions about hand hygiene. https://www.cdc.gov/handwashing/faqs.html. (CDC, October 14, 2020).
Centers for Disease Control and Prevention (CDC). (2021, January 8).
Hand Hygiene in Healthcare Settings. https://www.cdc.gov/handhygiene/providers/index.html. (CDC, January 8, 2021).
Centers for Disease Control and Prevention (CDC) and Environmental
Protection Agency (EPA). (2021a, April 5). Reopening guidance for
cleaning and disinfecting public spaces, workplaces, businesses,
schools, and homes. https://www.cdc.gov/coronavirus/2019-ncov/community/reopen-guidance.html. (CDC, April 5, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, April 5).
Cleaning and disinfection for households: Interim recommendations
for U.S. households with suspected or confirmed COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cleaning-disinfection.html. (CDC, April 5, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, April 5).
Cleaning and disinfecting your facility. https://www.cdc.gov/coronavirus/2019-ncov/community/disinfecting-building-facility.html.
(CDC, April 5, 2021c).
Centers for Disease Control and Prevention (CDC). (2021d, April 5).
Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for
Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html. (CDC,
April 5, 2021d).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Environmental Protection Agency (EPA). (2021, February 17). How does
EPA know that the products on List N work on SARS-CoV-2? https://www.epa.gov/coronavirus/how-does-epa-know-products-list-n-work-sars-cov-2. (EPA, February 17, 2021).
Environmental Protection Agency (EPA). (2021, April 9). List N tool:
COVID-19 disinfectants. https://cfpub.epa.gov/giwiz/disinfectants/index.cfm. (EPA, April 9, 2021).
Haque, M. (2020). Handwashing in averting infectious diseases:
Relevance to COVID-19. Journal of Population Therapeutics and
Clinical Pharmacology, 27(S Pt 1), e37-e52. https://doi.org/10.15586/jptcp.v27SP1.711. (Haque, July 12, 2020).
Honein, MA et al., (2020, December 11). Summary of Guidance for
Public Health Strategies to Address High Levels of Community
Transmission of SARS-CoV-2 and Related Deaths, December 2020. MMWR
Morb Mortal Wkly Rep 2020; 69: 1860-1867. DOI: http://dx.doi.org/10.15585/mmwr.mm6949e2. (Honein et al., December 11, 2020).
Kampf, G. et al., (2020). Persistence of coronaviruses on inanimate
surfaces and their inactivation with biocidal agents. The Journal of
Hospital Infection, 104(3), 246-251. https://doi.org/10.1016/j.jhin.2020.01.022. (Kampf et al., February 6, 2020).
Kratzel, A. et al., (2020, July). Inactivation of SARS-CoV-2 by
WHO--recommended hand rub formulations and alcohols. Emerging
Infectious Diseases, 26(7), 1592-1595. https://doi.org/10.3201/eid2607.200915. (Kratzel et al., July 2020).
Rabie, T. and Curtis, V. (2006). Handwashing and risk of respiratory
infections: A quantitative systematic review. Tropical Medicine &
International Health, 11(3), 258-267. https://doi.org/10.1111/j.1365-3156.2006.01568.x. (Rabie and Curtis, March 7, 2006).
Riddell, S. et al., (2020, October 7). The effect of temperature on
persistence of SARS-CoV-2 on common surfaces. Virology journal,
17(1), 145. https://doi.org/10.1186/s12985-020-01418-7. (Riddell et
al., October 7, 2020).
Rundle, C. et al., (2020, July 22). Hand hygiene during COVID-19:
Recommendations from the American Contact Dermatitis Society.
Journal of the American Academy of Dermatology, 83(6), 1730-1737.
https://doi.org/10.1016/j.jaad.2020.07.057. (Rundle et al., July 22,
2020).
Siddharta, A. et al., (2017, March 15). Virucidal activity of World
Health Organization--recommended formulations against enveloped
viruses, including Zika, Ebola, and Emerging Coronaviruses. The
Journal of Infectious Diseases, 215(6), 902-906. https://doi.org/10.1093/infdis/jix046. (Siddharta et al., March 15, 2017).
Siegel, J., Rhinehart, E., Jackson, M., Chiarello, L., and the
Healthcare Infection Control Practices Advisory Committee. (2007).
2007 Guideline for isolation precautions: Preventing transmission of
infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).
van Doremalen, N. et al., (2020, April 16). Aerosol and surface
stability of SARS-CoV-2 as compared with SARS-CoV-1. The New England
Journal of Medicine, 382(16), 1564-1567. https://doi.org/10.1056/NEJMc2004973. (van Doremalen et al., April 16, 2020).
Wang, Y., Tian, H., Zhang, L., Zhang, M., Guo, D., Wu, W. (2020).
Reduction of secondary transmission of SAR-CoV-2 in households by
face mask use, disinfection and social distancing: A cohort study in
Beijing, China. BMJ Global Health, 5, e002794. doi: 10.1136/bmjgh-
2020-002794. (Wang et al., May 11, 2020).
World Health Organization (WHO). (2020, May 14). Coronavirus disease
2019 (COVID-19): Situation report, 115. https://apps.who.int/iris/handle/10665/332090. (WHO, May 14, 2020).
World Health Organization (WHO). (2020, July 9). Transmission of
SARS-CoV-2: Implications for infection prevention precautions.
https://www.who.int/news-room/commentaries/detail/transmission-of-sars-cov-2-implications-for-infection-prevention-precautions. (WHO,
July 9, 2020).
L. Ventilation
Improving existing ventilation and ensuring optimal performance of
ventilation is an effective way to reduce viral transmission in
occupational populations. Work sites with existing heating,
ventilation, and air conditioning (HVAC) systems can utilize
improvements to, and maintenance of, high performance ventilation as
part of a layered response for infectious disease control. The
effectiveness of ventilation in controlling disease transmission is
based on scientific research and the recommendations of well-respected
occupational safety and health organizations, including government
agencies.
As explained in Grave Danger (Section IV.A. of the preamble), there
is evidence of airborne COVID-19 transmission within enclosed spaces
with inadequate ventilation. As a result, there is considerable support
for ensuring adequate ventilation through maintenance and improvements.
Federal agencies, international organizations, industry associations,
and scientific researchers agree that ensuring adequate ventilation is
important in reducing potential airborne transmission of COVID-19
(ASHRAE, April 14, 2020; Schoen, May 2020; WHO, May 10, 2020; AIHA,
September 9, 2020; CDC, May 7, 2021; CDC, April 7, 2021; CDC, March 23,
2021; Tang et al., August 7, 2020; Morawska et al., May 27, 2020).
In one scientific brief, the CDC provides a basic overview of how
ventilation can reduce the transmission of COVID-19 in indoor spaces.
Once respiratory droplets are exhaled, the CDC explains, they move
outward from the source and their concentration decreases through
fallout from the air (largest droplets first, smaller later) combined
with dilution of the remaining smaller droplets and particles into the
growing volume of air they encounter (CDC, May 7, 2021). Without
adequate ventilation, continued exhalation can lead to the amount of
infectious smaller droplets and particles produced by people with
COVID-19 to become concentrated enough in the air to spread the virus
to other people (CDC, May 13, 2021).
Ventilation controls the transmission of COVID-19 in two ways.
First, improving indoor ventilation by appropriately maximizing air
exchanges and by maintaining and improving heating, ventilation, and
air-conditioning (HVAC) systems can disperse and decrease the
concentration of COVID-19-containing small droplets and particles
suspended in the air. The lower the concentration, the less likely some
of those viral particles can be inhaled into an employee's lungs;
contact their eyes, nose, or mouth; or fall out of the air to
accumulate on surfaces. Protective ventilation practices and
interventions can reduce the airborne concentration, which reduces the
overall viral dose to occupants (CDC, March 23, 2021). Improved
ventilation can also significantly reduce the airborne time of
respiratory droplets (Somsen et al., May 27, 2020; CDC, March 23,
2021). As a result, the risk of transmission of COVID-19 indoors is
reduced, which makes workplaces safer (Schoen, May 2020; CDC, April 7,
2021; CDC, March 23, 2021; Honein et al., December 11, 2020).
Ventilation systems alone cannot completely prevent airborne
transmission (EPA, July 16, 2020; CDC, March 23, 2021), but are
particularly effective when implemented in conjunction with additional
control measures in a layered approach, including other engineering
controls and other protections required in this ETS.
Second, air filters in HVAC systems remove particles, including
aerosolized particles containing COVID-19, from
recirculated air streams before returning the air to workspaces.
Increased filter efficiency is a component of the HVAC system which can
be adjusted to reduce the risk of COVID-19 transmission (Schoen, May
2020; ASHRAE, April 14, 2020; CDC, May 7, 2021; CDC, March 8, 2021;
CDC, March 23, 2021; Morawska et al., May 27, 2020). Minimum Efficiency
Reporting Values (MERV) report a filter's ability to capture larger
particles between 0.3 and 10 microns ([micro]m). MERV ratings range
from 1 to 16, and a higher rating indicates a more efficient filter.
The virus that causes COVID-19 is approximately 0.125 [micro]m in
diameter; however, the virus is contained in infectious particles,
droplets, and droplet nuclei (dried respiratory droplets) that are
predominantly 1 [micro]m in size and larger.
The CDC recommends increasing filtration to the highest extent
possible that is compatible with the design of the HVAC system (CDC,
March 23, 2021). The American Society of Heating, Refrigeration, and
Air-Conditioning Engineers (ASHRAE) recommends using filters with a
MERV rating of at least 13, where feasible, or the highest level
compatible with the specified HVAC system, to help capture the
infectious aerosols containing COVID-19 (Schoen, May 2020; ASHRAE,
December 8, 2020). The use of filtration has also been supported by
others, including Mousavi et al., August 26, 2020. A MERV rating of 13
is at least 85-percent efficient at capturing particles from 1 [micro]m
to 3 [micro]m in size (Schoen, May 2020; CDC, March 8, 2021; CDC, March
23, 2021), which is the size of the particles carrying COVID-19. A
MERV-14 filter is at least 90% efficient at capturing particles of this
same size, and efficiencies for MERV-15 and MERV-16 filters are even
greater. As such, filters with MERV ratings of 13 or greater are much
more efficient at capturing particles of this size than a MERV 8 filter
(CDC, March 23, 2021).
The ability of HVAC systems to reduce the risk of exposure depends
on many factors, including design features, operation and maintenance
practices, and the quality and quantity of outdoor air supplied to the
space. The CDC has emphasized that building owners and operators should
ensure that ventilation systems are functioning properly and providing
acceptable levels of indoor air quality for the occupancy level of the
given space. Consultation with an HVAC professional will help ensure
that improvements to ventilation systems are implemented in accordance
with the capacity and design of the HVAC system, according to state and
local building codes and guidelines, and to avoid imbalances that could
negatively alter other indoor air quality parameters (e.g.,
temperature, humidity, moisture) (EPA, July 16, 2020; CDC, March 23,
2021).
The CDC has also recommended increasing airflow (CDC, March 23,
2021) to occupied spaces, if possible. One way to achieve this is by
opening windows and doors (Howard-Reed et al., February 2002; CDC,
March 23, 2021), where feasible and as weather conditions permit.
However, decisions to open windows and doors should be done after
evaluating other safety and health risks for occupants, such as risk of
falling or breathing outdoor environmental contaminants (e.g., carbon
monoxide, molds, and pollens) (CDC, April 7, 2021; CDC, March 8, 2021;
CDC, March 23, 2021). In order for this type of ventilation to serve as
an effective COVID-19 control, the air flow must be directed so that
contaminated air is not funneled through workspaces toward another
person.
Based on the best available evidence, the agency concludes that
implementation of improved ventilation and maintaining HVAC system
performance is an effective and necessary approach to reduce incidence
of COVID-19 both on its own and also when complemented by other
measures as part of a multi-layered strategy to minimize employee
exposure to the grave COVID-19 danger.
References
American Industrial Hygiene Association (AIHA). (2020, September 9).
Reducing the Risk of COVID-19 Using Engineering Controls: Guidance
Document. https://aiha-assets.sfo2.digitaloceanspaces.com/AIHA/resources/Guidance-Documents/Reducing-the-Risk-of-COVID-19-using-Engineering-Controls-Guidance-Document.pdf. (AIHA, September 9,
2020).
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE). (2020, April 14). ASHRAE Position Document on
Infectious Aerosols. https://www.ashrae.org/file%20library/about/position%20documents/pd_infectiousaerosols_2020.pdf. (ASHRAE, April
14, 2020).
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE). (2020, December 8). Debunking myths about MERV,
air filtration. https://www.ashrae.org/news/ashraejournal/debunking-myths-about-merv-air-filtration. (ASHRAE, December 8, 2020).
Centers for Disease Control and Prevention (CDC). (2021, March 8).
Guidance for Businesses and Employers Responding to Coronavirus
Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html. (CDC, March 8, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 23).
Ventilation. https://www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html. (CDC, March 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 7).
COVID-19 Employer Information for Office Buildings. https://www.cdc.gov/coronavirus/2019-ncov/community/office-buildings.html.
(CDC, April 7, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/coronavirus/2019-ncov/more/scientific-brief-sars-cov-2.html. (CDC,
May 7, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 Spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Environmental Protection Agency (EPA). (2020, July 16). Ventilation
and Coronavirus (COVID-19). https://www.epa.gov/coronavirus/ventilation-and-coronavirus-covid-19. (EPA, July 16, 2020).
Honein, MA et al., (2020, December 11). Summary of Guidance for
Public Health Strategies to Address High Levels of Community
Transmission of SARS-CoV-2 and Related Deaths, December 2020. MMWR
Morb Mortal Wkly Rep 2020; 69: 1860-1867. DOI: http://dx.doi.org/10.15585/mmwr.mm6949e2. (Honein et al., December 11, 2020).
Howard-Reed, C. et al., (2002, February). The effect of opening
windows on air change rates in two homes. Journal of Air and Waste
Management Association 52: 147-159. (Howard-Reed et al., February
2002).
Morawska, L. et al, (2020, May 27). How can airborne transmission of
COVID-19 indoors be minimized? Environmental International 142:
105832. https://doi.org/10.1016/j.envint.2020.105832. (Morawska et
al., May 27, 2020).
Mousavi, ES et al., (2020, August 26). COVID-19 Outbreak and
Hospital Air Quality: A Systematic Review of Evidence on Air
Filtration and Recirculation. Environmental Science and Technology.
acs.est.0c03247. https://doi.org/10.1021/acs.est.0c03247. (Mousavi
et al., August 26, 2020).
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COVID-19 pandemic. ASHRAE Journal. (Schoen, May 2020).
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ventilated spaces and SARS-CoV-2 transmission. The Lancet 8: 658-
659. https://doi.org/10.1016/. (Somsen et al., May 27, 2020).
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al., August 7, 2020).
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19: Annex to Considerations in adjusting public health and social
measures in the context of COVID-19, May 2020. https://www.who.int/publications-detail-redirect/considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19. (WHO,
May 10, 2020).
M. Health Screening and Medical Management
As discussed in more detail in Grave Danger (Section IV.A. of the
preamble), COVID-19 is a disease that is primarily transmitted from
person to person through respiratory droplets that are produced when
someone breaths, talks, sneezes, or coughs, and the droplets contact
the eyes, nose, or mouth of another person. It may also infrequently be
transmitted by someone touching a contaminated surface and then
touching their eyes, nose, or mouth. Consequently, to effectively
reduce the transmission of COVID-19 in the workplace, it is necessary
to have a medical management program that identifies and removes
infected or likely infected employees from the workplace, and notifies
employees about possible exposures to COVID-19 so they can take
appropriate steps to further reduce transmission.
I. Employee Screening
Regular health screening for possible indications of COVID-19 is a
first step in detecting employees who might be COVID-19-positive so
those employees can seek medical care or testing, or inform the
employer if they have certain symptoms. While pre-symptomatic and
asymptomatic infections and the non-specificity of COVID-19 symptoms
make it difficult to quantify the accuracy of symptom screening in
predicting COVID-19, health screening is a strategy supported by the
CDC and the American College of Occupational and Environmental Medicine
(ACOEM). ACOEM recommends that employers implement a medical
surveillance program that includes educating and training employees on
how to recognize when they may have COVID-19, in order to prevent
employees with infections from entering the workplace (ACOEM, August
19, 2020).
The CDC recommends that employers conduct screening at the
worksite, or train employees to be aware of and recognize the signs and
symptoms of COVID-19 and to follow CDC recommendations to self-screen
for symptoms before coming to work (CDC, March 8, 2021). Screening for
employee symptoms, particularly when combined with their recent
activities (e.g., the likelihood they have had a recent exposure to
COVID-19), can help determine if the employee is suspected to have
COVID-19 or should be tested. Testing can be useful in guiding the
treatment that employees receive for their illness as well as
triggering isolation to prevent exposure to others (NASEM, November 9,
2020). The FDA (March 11, 2021) has issued a number of emergency use
authorizations for COVID-19 tests that detect infections with the SARS-
CoV-2 virus. CDC recommends prompt COVID-19 testing of anyone who has
had a known exposure to someone with COVID-19, has had a possible
exposure to someone with COVID-19, or has symptoms of COVID-19, as a
strategy to reduce SARS-CoV-2 transmission (Honein et al., December 11,
2020). Based on medical advice and information provided by testing,
employees can learn if they are suspected or confirmed to have COVID-
19. The earlier employees learn whether they are infected, the more
likely that workplace exposures can be prevented.
As explained below, it is necessary that employees who are
suspected or confirmed to have COVID-19 be removed from the workplace
to prevent transmission to other employees. However, because COVID-19
symptoms are non-specific and common with other infectious and non-
infectious conditions, not all individuals experiencing these symptoms
will necessarily have COVID-19. Thus, Struyf et al., (2021) concluded
that using a single sign or symptom of COVID-19 will result in low
diagnostic accuracy and that combinations of symptoms increase
specificity while decreasing sensitivity (explained in further detail
below); however the authors also noted that studies are lacking on
diagnostic accuracy of combinations of signs and symptoms.
The success of a screening strategy in identifying whether an
employee has COVID-19 is based on two factors: Sensitivity and
specificity for identifying COVID-19. Sensitivity refers to the ability
of the symptom screening strategy to correctly identify persons who
have COVID-19. Specificity refers to the ability of the symptom
screening strategy to correctly identify persons who do not have COVID-
19. As an example, a systematic review and meta-analysis by Pang et
al., (2020) determined a sensitivity of 0.48 and specificity of 0.93
for smell disorders in identifying COVID-19. This means that under the
scenarios in which the studies were conducted, screening for smell
disorders would correctly identify around 48% of individuals who have
COVID-19 (sensitivity), and would correctly identify 93% of individuals
who do not have COVID-19 (specificity).
A number of studies have been conducted to determine common
symptoms associated with COVID-19, along with their sensitivity and
specificity. In addition to the Pang et al., (2020) study, there have
been several other studies strongly linking smell and taste disorders
as a symptom indicative of COVID-19. In a review of 18 studies of
COVID-19 patients, Printza and Constantidis (2020) reported that loss
of either smell or smell and taste was reported in most studies, and
that that symptom is more prevalent in COVID-19 patients than in
patients suffering from other respiratory infections. The report also
found that the loss of smell was more prevalent among patients with a
less severe case of COVID-19 disease. Four systematic reviews, three of
which included meta-analyses, reported that for smell or taste
disorders, sensitivity ranged from 0.41 to 0.65 and specificity ranged
from 0.90 to 0.93 (Pang et al., 2020; Printza and Constantidis, 2020;
Kim et al., 2021; Struyf et al., 2021).
A systematic review found that while loss of taste or smell is the
most specific symptom of COVID-19, the most commonly reported symptoms
of COVID-19 were fever, cough, fatigue, shortness of breath, and sputum
production (Alimohamadi et al., 2020). In another review of a
convenience sample (i.e., a non-randomly selected sample based on
availability, opportunity, or convenience) of COVID-19 patients in the
United States, 96% of patients reported having a fever, a cough, or
shortness of breath (Burke et al., 2020). The review also found that
68% of hospitalized patients experienced all three of those symptoms,
but only 31% of non-hospitalized patients reported all three symptoms.
A systematic review by Kim et al., (2021) determined sensitivity and
specificity, respectively, for fever (0.6, 0.55), cough (0.59, 0.39),
and difficulty breathing (0.18, 0.84).
Although not intended to identify individuals who could potentially
have COVID-19, and the diagnostic accuracy of the approach is not
known, the surveillance definition used by the Council of State and
Territorial Epidemiologists (CSTE) provides insight on an approach to
using symptoms to identify possible cases of COVID-19 in the absence of
a more likely determination by a healthcare provider. The CSTE
surveillance definition for COVID-19 includes: (1) At least two of
the following symptoms: Fever (measured or subjective), chills, rigors
(i.e., shivering), myalgia (i.e., muscle aches), headache, sore throat,
nausea or vomiting, diarrhea, fatigue, congestion or runny nose; or (2)
any one of the following symptoms: Cough, shortness of breath,
difficulty breathing, new olfactory (i.e., smell) disorder, new taste
disorder; or (3) severe respiratory illness with a least one of the
following: Clinical or radiographic evidence of pneumonia, acute
respiratory distress syndrome (ARDS) (CSTE, 2020).
Given the non-specificity of COVID-19 symptoms, consultation with a
licensed healthcare provider can provide more insight on the likelihood
that an employee with certain symptoms has COVID-19. A licensed
healthcare provider can elicit key clinical information, such as
timing, frequency, intensity, and other factors in diagnosing the
patient, after considering different medical explanations. A licensed
healthcare provider can also elicit additional clinical information
(e.g., pre-existing medical conditions), elicit epidemiologic
information (e.g., exposure to COVID-19, travel history, rates of
community transmission), and order laboratory testing to assist with
the diagnosis of COVID-19 and differentiation from other medical
conditions.
In general, the presence of COVID-19 symptoms can alert employees
that they may have COVID-19, which will allow them to take appropriate
next steps. Thus, by monitoring for COVID-19 symptoms through regular
health screening, employees can better address their personal health
and avoid potentially infecting other people by seeking medical
attention and getting tested for COVID-19 as appropriate; informing
their employer if they are suspected or confirmed to have COVID-19,
including concerning symptoms; and remaining away from the workplace
where appropriate. Therefore, health screening is an effective strategy
for preventing the transmission of COVID-19 in the workplace.
II. Employee Notification to Employer of COVID-19 Illness or Symptoms
Employers can reduce workplace exposures by preventing employees
who are, or could be, COVID-19 positive from entering the workplace and
transmitting the disease to others. But to do so, employers must be
aware that an employee is suspected or confirmed to have COVID-19 or is
symptomatic. The Summary and Explanation (Section VIII of the preamble)
includes more discussion of the precise criteria and rationale for when
an employee is required to notify an employer that they are suspected
or confirmed to have COVID-19 or are experiencing certain types of
symptoms. It is critical that employees make their employers aware
promptly after the employee is suspected or confirmed to have COVID-19
through test, medical diagnosis, or the specific symptoms of concern
discussed in the Summary and Explanation (Section VIII of the
preamble). With this information the employer can act to help prevent
transmission in the workplace.
III. Employer Notification to Employees of COVID-19 Exposure in the
Workplace
Notifying employees of a possible exposure to someone confirmed to
have COVID-19 is an important and effective intervention to reduce
transmission. Under the ETS, this includes any employee who was not
wearing a respirator and any other required PPE while in close contact
with the individual with COVID-19 or while working in the same physical
space around the same time as the individual with COVID-19 and
consequently may have had contact with that individual or touched a
contaminated surface. As the CDC has recognized, notification is
important because it allows for an exchange of information with the
person exposed to someone with COVID-19 and helps ensure that person
can pursue quarantine, timely testing, medical evaluation, and other
necessary support services (CDC, February 26, 2021). Notification also
acts as a complement to an employer's regular health screening program
by informing employees who may have been exposed to COVID-19 in the
workplace, so that they can appropriately assess and monitor their
health and report any symptoms that may develop to their employer. It
is also important for employers to notify other employers whose
employees may have had close contact or been in the same area as those
infected individuals while not wearing required PPE so those employers
can notify their employees.
The impact that notification of possible COVID-19 exposures can
have in reducing COVID-19 transmission was demonstrated in a study by
Kucharski et al., (2020), which found that when location-specific
contact tracing and notification was used to make decisions on
isolation and home quarantine, transmission of COVID-19 was reduced by
64% when contact tracing was performed manually and 47% when performed
by an app. However, the authors found that while notification is
effective in helping to decrease the spread of COVID-19 by making
individuals aware of potential infections, it is not a standalone
measure. Notification must be used in a layered approach in order to
create an effective infection control plan.
IV. Medical Removal From the Workplace
Employers can substantially reduce disease transmission in the
workplace by removing employees who are suspected or confirmed to have
COVID-19 based on a COVID-19 test or diagnosis by a healthcare
provider, or who have developed certain symptoms or combinations of
symptoms associated with COVID-19. Employers can also reduce the risk
of COVID-19 in the workplace by removing employees who are at risk of
developing COVID-19 because they were recently exposed to someone with
COVID-19 in the workplace. According to the CDC, a major mitigation
effort for COVID-19 is ``to reduce the rate at which someone infected
comes in contact with someone not infected. . . .'' (CDC, February 16,
2021b).
The ETS focuses on removing employees from the workplace, rather
than specifying requirements for quarantine or isolation that are
typically outside the control of the employer because they would occur
away from the workplace, but the concept of separating infected or
potentially infected individuals from others is the same. Both the CDC
and ACOEM endorse the use of isolation and quarantine as measures
needed to reduce this rate of contact and consequently slow the spread
of COVID-19. Isolation ensures that persons known or suspected to be
infected with the virus stay away from all healthy individuals.
Isolating contagious, or potentially contagious, employees from their
co-workers can prevent further spread at the workplace and safeguard
the health of other employees. Quarantine is used to keep persons at
risk of developing COVID-19 away from all other people until it can be
determined whether the individual is infected following an exposure to
someone with suspected or confirmed COVID-19 (Honein et al., 2020).
The first two categories of employees who should be removed from
the workplace are those employees who are suspected to be or are
confirmed to have COVID-19 based on a COVID-19 test or diagnosis by a
healthcare provider and those employees who develop certain
COVID-19 symptoms.\25\ Removal of these two categories of employees is
consistent with isolation guidance from the CDC (February 11, 2021).
Employers also prevent further transmission of COVID-19 in the
workplace by providing employees a place to isolate from other workers
until they can go home if they arrive with, or develop, COVID-19
symptoms at work (CDC, February 16, 2021a; CDC, March 8, 2021). ACOEM
(August 19, 2020) also recommends that symptomatic employees stay home
to protect healthy workers. Several studies have focused on the impact
of isolating persons with COVID-19 from others during their likely
known infectious period, and those studies show that isolation is a
strategy that reduces the transmission of infections. For example,
Kucharski et al., (2020) found that transmission of SARS-CoV-2 would
decrease by 29% with self-isolation within the household, which would
extend to 37% if the entire household quarantined. Similarly, Wells et
al., (2021) found that isolation of individuals at symptom onset would
decrease the reproductive rate (R0) of COVID-19 from an R0 of 2.5 to an
R0 of 1.6. However, the study authors noted that when assuming low
levels of asymptomatic transmission the R0 never fell below one,
meaning there is a need for isolation to be used in concert with a more
robust and layered infection control program, as is required by other
provisions in the ETS.
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\25\ Evidence on the sensitivity and specificity of certain
symptom triggers is discussed above. The Summary and Explanation
(Section VIII of the preamble) includes more discussion of the
symptoms that trigger removal from the workplace and the rationale
for selection of those symptoms.
---------------------------------------------------------------------------
The third category of employees who should be removed from the
workplace to further reduce disease transmission are those who are at
risk of developing COVID-19 because they have had recent close contact
in the workplace with someone who is COVID-19-positive while not
wearing a respirator and all required PPE (CDC, March 12, 2021). The
need for removal of these employees is based on quarantine guidance
from CDC (December 2, 2020) and is consistent with CDC recommendations
for quarantine as a means of reducing workplace transmission (CDC,
February 16, 2021a). Such removal is important because infected
individuals are capable of transmitting the virus before they start
experiencing symptoms and are aware that they are ill, and many
(estimated to be 17% in one analysis) may never experience symptoms at
all (Byambasuren et al., December 11, 2020). Therefore, ensuring that
exposed employees are removed from work until it is unlikely that they
have developed COVID-19 is critical for preventing the transmission of
infections. CDC defines exposure through unprotected close contact as
being within 6 feet of an infected person for a cumulative total of at
least 15 minutes over a 24-hour period starting at 2 days before
illness onset (or 2 days before samples are collected for testing in
asymptomatic patients) and until the infected person meets the criteria
for ending isolation (CDC, March 1, 2021). The risk level of the
exposure depends on factors such as whether the healthcare provider was
wearing a facemask or respirator, if an AGP was being performed without
all recommended PPE, or if the patient had source control in place.
However, CDC does not recommend quarantine following close contact
with someone who is suspected or confirmed to have COVID-19, if the
person who had close contact meets all of the following criteria: (1)
They have been fully vaccinated for COVID-19; (2) it has been at least
2 weeks since the full vaccination was completed; and (3) they do not
develop any symptoms (CDC, May 13, 2021; CDC, March 12, 2021). CDC also
has analyzed accumulating evidence indicating that persons who have
recovered from laboratory-confirmed COVID-19 and remain symptom-free
may not have to quarantine again if exposed within three months of the
illness. CDC (March 16, 2021) concluded that although the evidence does
not definitively demonstrate the absence of reinfection within a three-
month period, the benefits of avoiding unnecessary quarantine likely
outweigh the risks of reinfection as long as other precautions such as
physical distancing, facemasks, and hygiene continue to be implemented.
CDC's recommendation was based on a review of more than 40 studies
examining evidence of re-infection in recovered individuals (complete
reference list included in CDC, (March 16, 2021). While many studies
demonstrated that reinfection can occur at least 90 days after
infection (e.g., Colson et al., 2020; Van Elslande et al., 2021), other
studies suggest re-infection is possible as early as 45 days after
infection (e.g., Abu-Raddad et al., 2020; Larson et al., 2020; Tillet
et. al., 2020). Although antibodies to the virus that causes COVID-19
have not been definitively correlated with protection from reinfection
and it is not clear what level of antibodies would be required for
protection, increasing numbers of studies are suggesting that the
majority of recovered patients develop antibodies specific for the
virus that causes COVID-19 (e.g., Deeks et al., 2020; Gudbjartsson et
al., 2020). Antibody responses have been reported to last for six
months or more in some studies (e.g., Choe et al., 2021; Dan et al.,
2021), but other studies suggested lower levels of antibodies or
detection of antibodies for shorter periods of time (e.g., Ibarrondo et
al., 2020; Seow et al., 2020). In addition to the production of
antibodies, immunity can be achieved through virus-specific T- and B-
cells (e.g., Kaneko et al., 2020), and some studies show that T- and B-
cell immunity can last for 6 months or more (e.g., Dan et al., 2021;
Hartley et al., 2020). Some studies suggest that T- and B-cell
responses could be higher in symptomatic versus asymptomatic adults
(e.g., Zuo et al., 2021). Results from animal challenge studies (e.g.,
Chandrashekar et al., 2020; Deng et al., 2020), and seropositive adults
in outbreak settings (Abu-Raddad et al., 2020; Lumley et al., 2021)
provide additional evidence that initial infection might protect
against reinfection.
In addition to the uncertainty noted above, CDC notes that risk of
reinfection may be increased in the future, with the circulation of
variants (e.g., CDC, March 16, 2021; Nonaka et al., 2021; Harrington et
al., 2021; Zucman et al., 2021). Because of the uncertainty regarding
reinfection and increased possibility of reinfection following exposure
to variants, the CDC recommends that employees be removed from the
workplace if they develop symptoms after close contact with someone who
has COVID-19, even if the employee is fully vaccinated or was confirmed
to have COVID-19 in the previous three months (CDC, May 13, 2021; CDC,
April 2, 2021).
V. Medical Removal Protection Benefits
Notification and removal will be most effective if the employees
responsible for reporting do not face potential financial hardships for
accurate reporting of symptoms and illnesses. As noted above, employers
must know that an employee is suspected or confirmed to have COVID-19
or has certain symptoms of COVID-19 before they can remove those
employees from the workplace. But removing employees from the workplace
based on their own reports is likely to prove an effective control for
COVID-19 only if the employees are not afraid they will be penalized
for making those reports. OSHA's experience demonstrates that employees
will self-report at a sufficient level to make removal program
effective only when removed employees do not face a significant
financial penalty--
such as lost income during the removal period--and when employees may
return to work after their removal period without any adverse action or
deprivation of rights or benefits because of the removal. Because the
employer will often have no other way to learn whether an employee is
suspected or confirmed to have COVID-19, or has certain symptoms of
COVID-19, medical removal protections are necessary to ensure that
employees are not disincentivized to report suspected or confirmed
COVID-19 or symptoms of COVID-19. Because infectious employees pose a
direct hazard to their co-workers, removing barriers to reporting
symptoms or confirmed diagnoses protects not only the reporting
employee but also every other employee who would otherwise be exposed
to infection.
OSHA's experience shows that the threat of lost earnings, benefits,
and/or seniority protection provides a significant disincentive for
employees to participate in workplace medical screening and reporting
programs (see United Steelworkers of America v. Marshall, 647 F.2d
1189, 1237 (D.C. Cir. 1981) (recognizing the importance of removing
financial disincentives for workers exposed to lead)). In the lead
rulemaking, OSHA adopted a medical removal protection benefits
provision in part due to evidence that employees were using chelating
agents to achieve a rapid, short-term reduction in blood lead levels
because they were desperate to avoid economic loss, despite the
possible hazard to their health from the use of chelating agents (43 FR
54354, 54446 (November 21, 1978)). OSHA's standards for cotton dust and
lead contain testimony from numerous employees indicating that workers
would be reluctant to report symptoms and participate in medical
surveillance if they fear economic consequences (43 FR at 54442-54443;
50 FR at 51154-51155). A major reason that OSHA included medical
removal protection benefits in the formaldehyde standard is because the
standard does not have a medical examination trigger, such as an action
level, but instead relies on annual medical questionnaires and employee
reports of signs and symptoms. Thus, the approach is completely
dependent on employee cooperation (57 FR at 22293). Literature reviews
have similarly reported that lack of compensation is one reason why
employees might go into work while sick (Heymann et al., 2020; Kniffen
et al., 2021). Based on this evidence, OSHA concludes that protection
of benefits for removed employees is necessary to maximize employee
reporting of suspected or confirmed COVID-19 and symptoms associated
with COVID-19. This in turn maximizes protection for all employees at
the workplace.
VI. Return to Work
After employees have been removed from the workplace as required by
this standard, the employer must ensure that they do not return to the
workplace until there is no longer a risk of disease transmission.
Scientific evidence is available to determine the appropriate duration
of isolation for COVID-19, which can be used to determine the
appropriate duration of removal from the workplace. As general
guidance, CDC recommends isolating symptomatic people with COVID-19 for
at least 10 to 20 days after symptom onset, dependent on factors such
as the severity of infection and health of the immune system. In most
cases, the CDC states that a person can end isolation when (i) 10 days
have passed since symptom onset; (ii) fever has been resolved (without
fever-reducing medications) for at least 24 hours; and (iii) other
symptoms (except loss of taste and smell) have improved. In cases of
severe illness, the decision to end isolation may require consultation
with an infection control expert. For persons who are confirmed
positive but never develop symptoms, CDC recommends ending isolation at
10 days after the first positive test (CDC, March 16, 2021). These
recommendations are based on scientific evidence reviewed by CDC which
suggest that levels of viral RNA in upper respiratory tract samples
begin decreasing after the onset of symptoms (CDC, March 16, 2021; CDC,
unpublished data, 2020, as cited in CDC, March 16, 2021; Midgley et
al., 2020; Young et al., 2020; Zou et al., 2020; W[ouml]lfel et al.,
2020; van Kampen et al., 2021). Levels of replication-competent viruses
(i.e., viruses that are able to infect cells and produce more
infectious viral particles) also decrease over time; with only two
possible exceptions, no replication-competent virus was detected after
10 days of symptom onset in individuals with mild-to-moderate disease
(CDC, unpublished data, 2020, as cited in CDC, March 16, 2021;
W[ouml]lfel et al., 2020; Arons et al., 2020; Bullard et al., 2020; Liu
et al., 2020a; Lu et al., 2020; personal communication with Young et
al., 2020, as cited in CDC, March 16, 2021; Korea CDC, May 19, 2020;
Quicke et al., 2020). In a study of persons with severe disease
(possibly complicated in some individuals by an immunocompromised
status), the median duration of shedding infectious virus was 8 days
after onset of symptoms, and the probability of shedding virus after 15
days was estimated at 5% or less (van Kampen et al., 2021). In severely
immunocompromised patients, ``sub-genomic virus RNA'' or replication
competent virus was detected beyond 20 days and as much as 143 days
after a positive virus test (e.g., Avanzato et al., 2020; Choi et al.,
2020). A large contact-tracing study found no evidence of infections in
individuals who had contact with infectious individuals in a household
or hospital when exposure occurred at least 6 days after illness onset
(Cheng et al., 2020). Accordingly, these studies support the CDC's
recommended isolation guidance (CDC, February 16, 2021a; CDC, February
18, 2021a; CDC, February 18, 2021b). However, as noted, CDC's
recommendations for isolation are broad guidance; the appropriate
duration for any given individual may differ depending on factors such
as disease severity or the health of the employee's immune system.
As a general rule, CDC does not recommend a testing strategy as a
means for determining when to end isolation, with the possible
exception of severely immunocompromised persons (CDC, March 16, 2021).
This is because tests to detect viral genetic material may yield
positive results after a person is no longer infectious. Except in a
very limited number of cases, studies have demonstrated that although
some individuals were observed to persistently shed virus (for up to 12
weeks), replication-competent virus has not been recovered at three
weeks past illness (Korea CDC, May 19, 2020; CDC, March 16, 2021; Li et
al., 2020; Xiao et al, 2020; Liu et al., 2020a; Quicke et al., 2020).
In addition, a study of 285 persons with persistent virus shedding,
including 126 who experienced recurrent symptoms, found no evidence
that any of the 790 contacts were infected from exposures to the people
with persistent virus shedding (Korea CDC, May 19, 2020; CDC, March 16,
2021).
On the other hand, testing conducted after onset of sensitive
symptoms associated with COVID-19 can identify individuals who are not
infected. Peak virus shedding has been reported to occur just before
and as symptoms are developing (Beeching et al., 2020; He et al.,
2020). Testing for COVID-19 soon after the onset of symptoms has been
estimated to result in a low false-negative rate of 10%, based on the
reported Polymerase Chain Reaction test sensitivity (Grassley et al.,
2020).
Return-to-work criteria for employees who are removed from the
workplace because they are at risk of developing COVID-19 after
exposure to someone with COVID-19 in the workplace, but have not yet
developed symptoms or tested positive themselves, are based on the
CDC's quarantine guidance. Based on available scientific evidence, the
CDC generally recommends a 14-day quarantine period for individuals who
have been exposed to a confirmed case of COVID-19 and are therefore at
risk of developing COVID-19 (CDC, December 2, 2020; CDC, March 12,
2021). The 14-day quarantine period is based on the conclusion that the
upper bound of the incubation period (the period between the point of
infection and symptom onset) for COVID-19 is 14 days, and that there is
a possibility that an unknowingly infected person can transmit the
disease if quarantine is discontinued before 14 days (CDC, December 2,
2020). The scientific community agrees that a 14-day quarantine period
is ideal. Linton et al., (2020) recommended a quarantine period of at
least 14 days, based on a mean incubation period of 5 days, with a
range of 2-14 days, in patients from and outside of Wuhan, China. Lauer
et al., (2020) concluded that the CDC recommendation to monitor for
symptoms for 14 days is supported by the evidence, including their
study of patients outside the Hubei province that reported a mean
incubation period of 5.1 days and symptom development within 11.5 days
in 97.5% of those who develop symptoms.
Although a 14-day quarantine is ideal and generally recommended,
the CDC has recognized that a shorter quarantine period may be less
burdensome and result in increased compliance. Therefore, the CDC
reviewed emerging scientific evidence to provide shorter quarantine
options that employers can consider if allowed by local public health
authorities (Oran and Topol, 2020; Johansson et al., 2020; Kucirka et
al., 2020; Clifford et al., 2020; Quilty et al., 2021; Wells et al.,
2021; Khader et al., 2020, as cited in CDC, December 2, 2020; Liu et
al., 2020b; Ng et al., 2021; Grijalva et al., 2020). One of those
options is testing for the virus at five days after exposure and ending
quarantine at seven days after exposure if results are negative.
Importantly, this option is only appropriate for individuals who do not
develop symptoms over the quarantine period (as such individuals should
instead be managed according to the CDC's isolation strategies). Based
on the evidence reviewed, CDC concluded that ending quarantine after a
negative test and seven days with no symptoms would result in a
residual transmission risk of about 5%, with an upper limit of about
12% (CDC, December 2, 2020).
VII. Conclusion
As demonstrated above, the best available evidence strongly
supports OSHA's conclusion that implementation of a comprehensive
medical management program which includes health screening;
notifications of potential exposures; removing employees who are COVID-
19 positive, suspected to be positive, have certain symptoms, or have
been exposed to a person with COVID-19 from the workplace until there
is no longer a risk of disease transmission; and protection of removed
employees' compensation, rights, and benefits are necessary measures to
reduce incidence of COVID-19 exposure in the workplace. Because the
virus that causes COVID-19 is spread through exposure to infected
individuals or surfaces contaminated by infected individuals, quickly
identifying and removing employees from the workplace who have
developed, likely developed, or are at heightened risk of developing
COVID-19 will allow employers to significantly reduce the spread of
COVID-19 in the workplace. The prompt identification and removal of
these employees can prevent transmission of the virus to others in the
workplace. In addition, medical removal protection provisions that
ensure compensation and protection of rights and benefits during
removal will encourage employees to report diagnoses of suspected or
confirmed-positive COVID-19 and symptoms. However, as noted above, some
employees with COVID-19 will not have symptoms, and testing to allow
employees to return to work after exposures to COVID-19 or experiencing
symptoms associated with COVID-19 will likely result in some false
negatives. Therefore, a medical management program should be
complemented by other measures as part of a multi-layered strategy to
minimize employee exposure to the grave danger of COVID-19.
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PMC7801729. (van Kampen et al., 2021).
Wells, CR. et al., (2021). Optimal COVID-19 quarantine and testing
strategies. Nature Communications 2021 Jan 7; 12(1): 356. doi:
10.1038/s41467-020-20742-8. PMID: 33414470; PMCID: PMC7788536.
(Wells et al., 2021).
W[ouml]lfel, R. et al., (2020). Virological assessment of
hospitalized patients with COVID-2019. Nature. 2020 May; 581(7809):
465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1. Erratum
in: Nature. 2020 Dec; 588(7839): E35. PMID: 32235945. (W[ouml]lfel
et al., 2020).
Xiao, F. et al., (2020). Infectious SARS-CoV-2 in Feces of Patient
with Severe COVID-19. Emerging Infectious Diseases. 2020 Aug; 26(8):
1920-1922. doi: 10.3201/eid2608.200681. Epub 2020 May 18. PMID:
32421494; PMCID: PMC7392466. (Xiao et al., 2020).
Young, BE. et al., (2020). Epidemiologic Features and Clinical
Course of Patients Infected With SARS-CoV-2 in Singapore. Journal of
the American Medical Association. 2020 Apr 21; 323(15): 1488-1494.
doi: 10.1001/jama.2020.3204. Erratum in: JAMA. 2020 Apr 21; 323(15):
1510. PMID: 32125362; PMCID: PMC7054855. (Young et al., 2020).
Zou, L. et al., (2020). SARS-CoV-2 Viral Load in Upper Respiratory
Specimens of Infected Patients. New England Journal of Medicine.
2020 Mar 19; 382(12): 1177-1179. doi: 10.1056/NEJMc2001737. Epub
2020 Feb 19. PMID: 32074444; PMCID: PMC7121626. (Zou et al., 2020).
Zucman, N. et al., (2021). Severe reinfection with South African
SARS-CoV-2 variant 501Y.V2: A case report. Clinical Infectious
Diseases. 2021 Feb 10: ciab129. doi: 10.1093/cid/ciab129. Epub ahead
of print. PMID: 33566076; PMCID: PMC7929064. (Zucman et al., 2021).
Zuo, J. et al., (2021). Robust SARS-CoV-2-specific T cell immunity
is maintained at 6 months following primary infection. Nature
Immunology. 2021 Mar 5. doi: 10.1038/s41590-021-00902-8. Epub ahead
of print. PMID: 33674800. (Zuo et al., 2021).
N. Vaccination
Vaccines are an important tool to reduce the transmission of COVID-
19 in the workplace. A vaccine serves three critical functions: First,
it can reduce the likelihood that a vaccinated person will develop
COVID-19 after exposure to SARS-CoV-2; second, it can lessen the
symptoms and effects in cases where the vaccinated person does contract
COVID-19; and third, although the CDC still recommends source controls
for vaccinated healthcare workers, it also acknowledges a growing body
of evidence that vaccination can reduce the potential that a vaccinated
person will transmit the SARS-CoV-2 virus to non-vaccinated co-workers
(CDC, April 12, 2021; CDC, April 27, 2021). Vaccination also serves an
important role in reducing health disparities in employees of certain
demographics, who may be especially vulnerable to severe health effects
or death from COVID-19 (Dooling et al., December 22, 2020). Below OSHA
provides a general explanation of the need for vaccination measures in
the ETS; however, a fuller explanation of the efficacy of existing
vaccines and their impact on the risk of COVID-19 infection and
transmission is discussed in Grave Danger (Section IV.A. of the
preamble).
OSHA has long recognized the importance of vaccinating employees
against preventable illnesses to which they may be exposed on the job.
The Bloodborne Pathogens standard, for example, requires the hepatitis
B vaccine be made available to any employees with occupational exposure
to blood and other potentially infectious materials, in order to reduce
the risk of hepatitis B infection and subsequent illness and death (56
FR 64004, 64152 (Dec. 6, 1991)). A number of professional health
organizations have similarly long recognized the importance of
vaccinating employees to prevent illness. This is particularly true in
healthcare industries, where employees are more regularly at risk of
occupational exposure to transmissible diseases. For example, the
Advisory Committee on Immunization Practices (ACIP), which reviews
evidence of risk and vaccine effectiveness, recommends vaccinating
healthcare employees against numerous diseases, including influenza,
another viral disease spread through droplet transmission (Shefer et
al., November 25, 2011). Similarly, both HICPAC and the American
Hospital Association have encouraged and endorsed vaccination programs
or policies for healthcare workers. CDC, WHO, and the National
Academies of Science, among others, have all acknowledged that broad
vaccination of all people for COVID-19, in combination with other
public health measures, is a critical tool that can be used to address
the pandemic (CDC, April 29, 2021; WHO, January 8, 2021; NASEM, 2020).
Any vaccines offered to employees must be demonstrated to be safe
and effective. Fortunately, over the course of the pandemic, there have
been extensive efforts to develop COVID-19 vaccines. As discussed in
greater detail in Grave Danger (Section IV.A. of the preamble), there
are presently three COVID-19 vaccines authorized for emergency use by
the FDA in the United States: the Pfizer-BioNTech COVID-19 vaccine, the
Moderna COVID-19 vaccine, and the Janssen Biotech, Inc. Johnson and
Johnson COVID-19 vaccine, each recommended for use by ACIP in persons
at least 12 years of age and older for the Pfizer-BioNTech vaccines or
18 years of age and older for the Moderna and Johnson and Johnson
(Janssen) vaccines (Oliver et al., December 18, 2020; Oliver et al.,
January 1, 2021; FDA, April 9, 2021; FDA, April 1, 2021; FDA, February
26, 2021; FDA, May 10, 2021). In determining whether to grant EUA for a
new COVID-19 vaccine, the FDA considers several statutory criteria
provided in section 564 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-3). In evaluating an EUA request, FDA considers, among
other things, the totality of scientific evidence available to
determine if it is reasonable to believe that the vaccine may be
effective (i.e., an efficacy of at least 50%) in preventing COVID-19
and that the known and potential benefits of the vaccine, when used to
prevent COVID-19, outweigh the known and potential risks of the vaccine
(FDA, April 9, 2021; FDA, April 1, 2021; FDA, February 26, 2021). The
product manufacturer must also demonstrate quality and consistency in
manufacturing. Accordingly, any COVID-19 vaccine that receives an EUA
from the FDA--including the Pfizer-BioNTech vaccine, Moderna vaccine,
the Johnson and Johnson (Janssen) vaccine, and any future vaccine that
receives such an authorization after the issuance of this ETS--has been
shown to be sufficiently safe and effective.
All three vaccines that have been authorized to date, including the
Pfizer-BioNTech, Moderna, and Johnson & Johnson (Janssen) vaccines,
have been found to be highly effective for the appropriate ages (Oliver
et al., December 18, 2020; Oliver et al., January 1, 2021; Polack et
al., December 31, 2020; FDA, December 17, 2020; FDA, December 10, 2020;
FDA, February 26, 2021). The vaccines were also found to be effective
in preventing disease that is severe or requires hospitalization. The
evidence
available at this time, however, does not yet establish that the
vaccines eliminate the potential for asymptomatic COVID-19 development;
rather, fully vaccinated people are less likely to have asymptomatic
infection or transmit SARS-CoV-2 to others (CDC, May 14, 2021). All
three authorized vaccines have met the authorization standard for
safety, with the majority of adverse effects observed to be mild or
moderate in severity and transient, including: fatigue; headache;
chills; muscle pain; joint pain; lymphadenopathy (swelling or
enlargement of lymph nodes) on the same side as the injection; and
injection site pain, redness, and swelling (CDC, December 13, 2020;
CDC, December 20, 2020; CDC, May 14, 2021; Oliver et al., December 18,
2020; Oliver et al., January 1, 2021; Polack et al., December 31, 2020;
FDA, December 17, 2020; FDA, December 10, 2020; FDA, February 26,
2021).
Further, as discussed more extensively in the Summary and
Explanation (Section VIII of the preamble) requirement for paid time
off for vaccination, vaccination can only function as an effective
control if workers have access to it. Additional explanation of the
importance of removing barriers to controls is also discussed in
Summary and Explanation (see discussion of requirements that employees
receive protections of the ETS at no cost, as well as requirements for
paid time off for vaccination, both in Section VIII of the preamble).
Vaccination References
Centers for Disease Control and Prevention (CDC). (2020, December
13). Local reactions, systemic reactions, adverse events, and
serious adverse events: Pfizer-BioNTech COVID-19 vaccine. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html. (CDC, December 13, 2020).
Centers for Disease Control and Prevention (CDC). (2020, December
20). Local reactions, systemic reactions, adverse events, and
serious adverse events: Moderna COVID-19 vaccine. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html. (CDC, December 20, 2020).
Centers for Disease Control and Prevention (CDC). (2021, April 12).
Benefits of getting a COVID-19 vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html. (CDC, April
12, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 27).
Updated Healthcare Infection Prevention and Control Recommendations
in Response to COVID-19 Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html.
(CDC, April 27, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 29).
FAQ ``Why would a vaccine be needed when we can do other things . .
.?. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html.
(CDC, April 29, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 14).
Interim clinical considerations for use of COVID-19 vaccines
currently authorized in the United States. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fpfizer%2Fclinical-consideratio%E2%80%A6. (CDC, May 14, 2021).
Dooling, K et al., (2020, December 22). The Advisory Committee on
Immunization Practices' updated interim recommendation for
allocation of COVID-19 vaccine--United States, December 2020. MMWR
Rep 2021; 69: 1657-1660. DOI: http://dx.doi.org/10.15585/mmwr.mm695152e2. (Dooling et al., December 22, 2020).
Food and Drug Administration (FDA). (2020, December 10). FDA
briefing document. Pfizer-BioNTech COVID-19 Vaccine. https://www.fda.gov/media/144245/download. (FDA, December 10, 2020).
Food and Drug Administration (FDA). (2020, December 17). MRNA-1273
sponsor briefing document (Moderna). https://www.fda.gov/media/144453/download. (FDA, December 17, 2020).
Food and Drug Administration (FDA). (2021, February 26). FDA
Briefing Document: Janssen Ad.COV2.S Vaccine for the Prevention of
COVID-19. (FDA, February 26, 2021)
Food and Drug Administration (FDA). (2021, April 1). Moderna COVID-
19 vaccine. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine. (FDA,
April 1, 2021).
Food and Drug Administration (FDA). (2021, April 9). Pfizer-BioNTech
COVID-19 vaccine. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine. (FDA, April 9, 2021).
Food and Drug Administration (FDA). (2021, May 10). Pfizer-BioNTech
COVID-19 vaccine EUA Letter of Authorization Reissued. https://www.fda.gov/media/144412/download. (FDA, May 10, 2021).
National Academy of Sciences, Engineering, and Medicine (NASEM).
(2020). Framework for equitable allocation of COVID-19 vaccine.
https://www.nap.edu/download/25917. (NASEM, 2020).
Oliver, S et al., (2020, December 18). The Advisory Committee on
Immunization Practices' interim recommendation for use of Pfizer-
BioNTech COVID-19 vaccine--United States, December 2020. MMWR Rep
2020; 69: 1922-1924. DOI: http://dx.doi.org/10.15585/mmwr.mm6950e2.
(Oliver et al., December 18, 2020).
Oliver, S et al., (2020, December 20). The Advisory Committee on
Immunization Practices' interim recommendation for use of Moderna
COVID-19 vaccine--United States, December 2020. MMWR Rep 2021; 69:
1653-1656. DOI: http://dx.doi.org/10.15585/mmwr.mm695152e1. (Oliver
et al., January 1, 2021).
Polack, F et al., (2020). Safety and efficacy of the BNT162b2 mRNA
Covid-19 vaccine. New England Journal of Medicine, 383(27), 2603-
2615. doi: 10.1056/nejmoa2034577. (Polack et al., December 31,
2020).
Shefer, A. et al., (2011, November 25). Immunization of health-care
personnel: Recommendations of the Advisory Committee on Immunization
Practices (ACIP). MMWR Recommendations and Reports 60(RR07); 1-45.
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm. (Shefer et
al., November 25, 2011).
World Health Organization (WHO). (2021, January 8). COVID-19
vaccine. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines. (WHO, January 8, 2021).
O. Training
The CDC has determined that training is a necessary component of a
comprehensive control plan for COVID-19. The WHO has also determined
that training is an important control strategy for COVID-19 (WHO, May
10, 2020). When providing guidance for employers, the CDC has said that
employees need to be educated on steps they can take to protect
themselves from potential COVID-19 exposures at work. Employers
informing employees of the hazards to which employees may be exposed
while working is a cornerstone of occupational health and safety (OSHA,
2017). Employees play a particularly important role in reducing
exposures because appropriate application of work practices and
controls limit exposure levels. Employees therefore need to be informed
of the grave danger of COVID-19, as well as the workplace measures
included in their employers' COVID-19 plans because those measures are
necessary to reduce risk and provide protection to employees. Employees
must know what protective measures are being utilized and be trained in
their use so that those measures can be effectively implemented.
Training has been shown to be an effective tool to reduce injury
and illness (Burke et al., February 2006), but training is even more
critical when the workplace hazard includes the potential transmission
of the potentially deadly SARS-CoV-2 virus from one employee to
another: One improperly trained employee could increase risk for that
employee and for all of that employee's contacts, including coworkers.
Therefore, training is an essential component of a layered approach to
minimizing the risk of contracting COVID-19 in the workplace.
Training and education provide employees and managers an increased
understanding of existing safety and health programs. A thorough
understanding of these programs is necessary so employees can more
effectively contribute to their development and implementation.
Training provides employers, managers, supervisors, and employees with
the knowledge and skills needed to do their work safely and to avoid
creating hazards that could place themselves or others at risk, as well
as awareness and understanding of workplace hazards and how to
identify, report, and control them. Specialized training can address
unique hazards.
Because OSHA has long recognized the importance of training in
ensuring employee safety and health, many OSHA standards require
employers to train employees (e.g., the Bloodborne Pathogen standard at
29 CFR 1910.1030(g)(2)). When required as a part of OSHA standards,
such as is required by this ETS, training helps to ensure that
employees are able to conduct work in a safe and healthful manner
(OSHA, April 28, 2010). Training is essential to ensure that both
employers and employees understand the sources of potential exposure to
COVID-19 and control measures to reduce exposure to the hazard.
Employee comprehension is critical to ensuring that training is an
effective control. If training information is not presented in a way
that all employees understand, the training will not be effective.
Employers must thus consider language, literacy, and social and
cultural appropriateness when designing and implementing training
programs for employees (O'Connor et al., 2014). Additionally, if
employers do not offer training to employees in a convenient manner,
employees may be less likely to participate in the training. Therefore,
to be effective, training must be offered during scheduled work times
and at no cost to the employee. This will ensure that all employees
will have the time and financial resources to receive training. This is
also consistent with other OSHA standards. For example, the Bloodborne
Pathogen standard requires training be provided at no cost and during
working hours (Sec. 1910.1030(g)(2)(i)) and in a manner employees
understand (Sec. 1910.1030(g)(2)(vi)).
Research dating back to the 1980s has found ``overwhelming
evidence'' of the effectiveness of training programs on employee
knowledge (NIOSH, 1998), as well as employee behaviors (NIOSH, January
2010). With enhanced knowledge of safety and health hazards and
controls, employees can implement safer work practices. This can result
in reductions in workplace-related illnesses (Burke et al., February
2006).
The CDC has stated that information on workplace policies should be
communicated clearly, frequently, and via multiple messages (CDC, March
8, 2021). Training and education on safe work practices and controls
should be used to raise awareness among employees. Emphasizing the
effectiveness of these workplace controls helps to counteract
misinformation. Additional training, such as on PPE and infection
control policies and procedures, should be given to employees in those
workplaces where there is a high risk of exposure to COVID-19 (WHO, May
10, 2020).
Scientific research and case studies have further reinforced the
importance of training in responding to the COVID-19 pandemic.
Researchers found that a COVID-19 outbreak was effectively contained as
a result of prompt implementation of infection control measures,
including early in-person education of employees on the signs,
symptoms, and transmission of COVID-19 (Hale and Dayot, August 13,
2020). Knowledge of PPE was markedly improved following training on PPE
for healthcare employees in China during the COVID-19 pandemic (Tan et
al., June, 2020).
Training has been widely recognized as a key component of
occupational safety and health. Even though the body of scientific
evidence on the importance of training during the COVID-19 pandemic is
limited given its ongoing nature, the evidence that does exist only
further emphasizes the important role of training in protecting the
health and safety of employees. As such, OSHA has concluded that
training is necessary to ensure proper implementation of the employer's
COVID-19 plan and all other control measures, and that such training
will reduce incidence of COVID-19 illness both on its own and when
complemented by other measures as part of a multi-layered strategy to
minimize employee exposure to the grave COVID-19 danger.
References
Burke, M.J. et al., (2006, February). Relative effectiveness of
worker safety and health training methods. American Journal of
Public Health 96: 315-324. (Burke et al., February 2006).
Centers for Disease Control and Prevention (CDC). (2021, March 8).
Guidance for Businesses and Employers Responding to Coronavirus
Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html. (CDC, March 8, 2021).
Hale, M. and Dayot, A. (2020). Outbreak Investigation of COVID-19 in
Hospital Food Service Workers. American Journal of Infectection
Control. S0196-6553(20)30777-X. https://doi.org/10.1016/j.ajic.2020.08.011. (Hale and Dayot, August 13,2020).
National Institute for Occupational Safety and Health (NIOSH).
(1998, June). Assessing Occupational Safety and Health Training: A
literature review, June 1998. https://www.cdc.gov/niosh/docs/98-145/pdfs/98-145.pdf?id=10.26616/NIOSHPUB98145. (NIOSH, June 1998).
National Institute for Occupational Safety and Health (NIOSH) (2010,
January). A systematic review of the effectiveness of training and
education for the protection of workers, January 2010.https://
www.cdc.gov/niosh/docs/2010-127/pdfs/2010-127.pdf. (NIOSH, January
2010).
O'Connor, T. et al., (2014). Occupational safety and health
education and training for underserved populations. New
Solutions24(1): 83-106. (O'Connor et al., 2014).
Occupational Safety and Health Administration (OSHA). (2010, April
28). Training Standards Policy Statement. https://www.osha.gov/dep/standards-policy-statement-memo-04-28-10.html.(OSHA, April 28,
2010).
Occupational Safety and Health Administration (OSHA). (2017).
Workers' Rights. https://www.osha.gov/sites/default/files/publications/osha3021.pdf.(OSHA, 2017).
Tan, W. et al., (2020, June). Whole-process emergency training of
personal protective equipment helps healthcare workers against
COVID-19: Design and effect. Journal of Occupational and
Environmental Medicine 62: 420-423. DOI: 10.1097/
JOM.0000000000001877. (Tan et al., June, 2020).
World Health Organization(WHO).(2020, May 10). Considerations for
public health and social measures in the workplace context of COVID-
19: Annex to Considerations in adjusting public health and social
measures in the context of COVID-19, May 2020. https://www.who.int/publications-detail-redirect/considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19.(WHO,
May 10, 2020).
VI. Feasibility
A. Technological Feasibility
This section presents an overview of the technological feasibility
assessment for OSHA's Emergency Temporary Standard (ETS) for COVID-19.
The ETS has four sections: Healthcare (29 CFR 1910.502); Mini
Respiratory Protection Program (29 CFR 1910.504); Severability (29 CFR
1910.505); and Incorporation by
Reference (29 CFR 1910.509). The ETS applies to all settings where any
employee provides healthcare services or performs healthcare support
services. The settings covered by the ETS are listed in Table VI.A.-1.
[GRAPHIC] [TIFF OMITTED] TR21JN21.001
The mini respiratory protection program section supplements the ETS
to provide additional protection to workers in appropriate cases. The
healthcare and mini respiratory protection program sections of the ETS
will be discussed below. It is not necessary to discuss the
severability or incorporation by reference sections, as those sections
do not by their own terms impose any requirements that raise issues of
technological feasibility.
Technological feasibility has been interpreted broadly to mean
``capable of being done'' (Am. Textile Mfrs. Inst. v. Donovan, 452 U.S.
490, 509-510 (1981)). A standard is technologically feasible if the
protective measures it requires already exist, can be brought into
existence with available technology, or can be created with technology
that can reasonably be expected to be developed, i.e., technology that
``looms on today's horizon'' (United Steelworkers of Am., AFL-CIO-CLC
v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980) (Lead I); Amer. Iron
& Steel Inst. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) (Lead II);
American Iron and Steel Inst. v. OSHA, 577 F.2d 825 (3rd Cir. 1978)).
Courts have also interpreted technological feasibility to mean that a
typical firm in each affected industry or application group will
reasonably be able to implement the requirements of the standard in
most operations most of the time (see Public Citizen v. OSHA, 557 F.3d
165 (3d Cir. 2009); Lead I, 647 F.2d at 1272; Lead II, 939 F.2d at
990).
OSHA's assessment focuses on the controls required by the ETS that
stakeholders may believe raise issues of technological feasibility.
These controls include the implementation of a COVID-19 plan and
healthcare-specific good infection control practices, as well the
following controls: Physical distancing; physical barriers; and
ventilation.\26\ As discussed below, OSHA's finding of technological
feasibility is supported by a large number of COVID-19 transmission
prevention plans and best practice documents it reviewed, as well as
physical distancing scenarios and a job matrix it developed, across the
healthcare sector.
---------------------------------------------------------------------------
\26\ As will be discussed later in this assessment, there are no
technological feasibility barriers related to compliance with other
requirements in the ETS (e.g., facemasks, respirators, cleaning and
disinfection, health screening and medical management, employee
notification).
---------------------------------------------------------------------------
While OSHA focuses on certain types of evidence in specific parts
of the analysis, much of the evidence supports other discrete findings
made by OSHA. Thus, for example, while OSHA focuses on its review of
plans and best practice documents in establishing the feasibility of
developing and implementing a COVID-19 plan, that evidence also
supports the feasibility of implementing healthcare-specific good
infection control practices, physical distancing and physical barriers,
and ventilation.
In addition, this analysis discusses only a few examples of the
plans and best practice documents it reviewed, does not recount every
element of the
plans and best practice documents that it reviewed, and does not
recount all details of the scenarios and job matrix it developed. OSHA
based its technological feasibility assessment on all the evidence in
the docket, and not just the select portions discussed here. The
discussion below is merely illustrative of the full complement of
evidence reviewed to demonstrate that employers have implemented the
controls required by the ETS.
Finally, OSHA's finding of technological feasibility should not be
read to indicate that individual plans or best practice documents OSHA
reviewed are ETS-compliant, that lack of inclusion of a control in a
plan or document indicates the control is infeasible, that the use of a
barrier by employers in a given situation indicates that physical
distancing was not feasible in that situation, or that a particular
control used (e.g., a plastic sheet or curtain used as a physical
barrier) is compliant with the ETS's requirements. The plans and best
practice documents are intended to show two things: (1) That developing
plans to address COVID-19 in various workplaces is both common and
feasible, and (2) that the controls required by the ETS have been
implemented and are feasible in the healthcare settings. The specifics
of the plans may vary, but the ETS COVID-19 plan requirements are
written as performance requirements that provide sufficient flexibility
to ensure that it is feasible for employers to develop and implement
such a plan, including appropriate controls, for any given healthcare
workplace.
I. The ETS's Approach to Employee Protection
The ETS generally includes provisions that are based on and in
accordance with applicable CDC and other well-established guidelines
for good infection control practices relevant to the exposures
encountered by employees during their job tasks. For example, the ETS
requires the employer to develop and implement policies and procedures
to adhere to Standard and Transmission-Based Precautions. As discussed
in detail in the Need for Specific Provisions (Section V of the
preamble, these requirements are consistent with well-established CDC
and other guidelines that are routinely followed by employers subject
to the ETS. That the ETS is based on CDC and other guidelines or
practices that are well established and have been routinely followed by
many employers both before and during the pandemic is compelling
evidence supporting OSHA's finding of technological feasibility.
Moreover, as described in more detail in the Need for Specific
Provisions (Section V of the preamble), COVID-19 transmission control
practices work best when used together, overlapping their protective
impact. To this end, the COVID-19 ETS provides a multilayered approach
in which a combination of control measures must be implemented to
minimize the risks of exposure to COVID-19. Thus, to effectively reduce
the risk, employers must ensure that they follow all requirements of
the ETS that are feasible. As discussed in the Need for Specific
Provisions (Section V of the preamble), the OSHA regulatory text
reflects a multilayered strategy by requiring employers to implement
multiple mitigation strategies with several layers of controls to lower
the risks of exposure and reduce the spread of disease. Utilizing
overlapping controls in a layered approach better ensures that no
inherent weakness in any one approach results in an infection incident.
OSHA emphasizes that the infection control practices required by the
ETS work best when used together, layering their protective impact
(Garner, 1996; Rusnak et al., September 2004; Miller et al., 2012; WHO,
2016). For example, in addition to requiring employers to ensure that
employees engage in physical distancing, wear facemasks and follow
healthy hand hygiene practices, employers must ensure the use of
physical barriers at fixed work locations outside of direct patient
care areas where 6 feet of physical distancing is not feasible and
ensure adequate building ventilation. No one measure can prevent
transmission by itself, but several layers combined can significantly
reduce the overall risk of COVID-19 transmission (e.g., a facemask
alone will not be enough to prevent the spread of COVID-19 without
physical distancing and other controls (Akhtar et al., December 22,
2020)).
Implementing multiple mitigation strategies is even more necessary
to reduce the risk, because it will not be feasible to apply every
control in every workplace situation. Thus, the ETS employs strategies
to ensure that employees will be protected even when a particular
control is not feasible. As discussed below, OSHA concludes that this
multilayered approach to employee protection is feasible based on its
review of commonly implemented healthcare-specific good infection
control practices contained in nationally recognized infection control
practices like CDC guidelines, employer plans, best practice documents,
scenarios, and a job matrix that show these precautions are already in
place or can be readily implemented by typical firms in the healthcare
sector.
OSHA emphasizes, finally, that although the ETS takes a
multilayered approach to employee protection, it also establishes how
and when controls must be used. For example, physical barriers are
required only where physical distancing is not feasible because, as
OSHA discusses in depth in Need for Specific Provisions (Section V of
the preamble), physical barriers work by preventing droplets from
traveling from the source (i.e., an infected person) to an employee,
and are particularly critical when physical distancing of 6 feet is not
feasible because most COVID-19 transmission occurs via respiratory
droplets that are spread from an infected individual during close
(within 6 feet) person-to-person interactions.
a. COVID-19 Plans
Paragraph (c) of the ETS requires the employer to develop and
implement a COVID-19 plan that includes policies and procedures to
minimize the risk of transmission of COVID-19, as reflected in
paragraphs (d) through (n) in the ETS. These provisions are summarized
in Table VI.A.-2 below, and are discussed in detail in Need for
Specific Provisions and Summary and Explanation (Sections V and VIII of
the preamble, respectively).
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OSHA conducted a search for existing COVID-19 plans and best
practices developed by employers, trade associations, and other
organizations and posted on their publicly available websites. OSHA's
search revealed 77 plans and best practice documents from companies and
trade associations in the Health Care and Social Assistance industry
sector that address COVID-19 hazards using the multilayered approach
and controls required by the ETS. To the extent individual plans are
not discussed specifically below, a breakdown with the name of the
company or organization, a description of the contents, and a link to
the plan can be found in the COVID-19 Plans by NAICS spreadsheet (ERG,
February 9, 2021).
Based on its review of these plans, OSHA concludes that it is
feasible for employers in typical firms in the healthcare sector to
comply with the requirements in the ETS for a COVID-19 plan.\27\ Below,
OSHA highlights the elements of a few of the plans and best practice
documents it reviewed. In each case, OSHA presumes that an organization
believes that the particular approaches contained in the organization's
own documents are technologically feasible.
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\27\ As stated, OSHA located 77 plans in the Health Care and
Social Assistance industry sector. Some of these plans do not
address protections that are covered by the ETS (i.e., they do not
cover settings where any employee provides healthcare services or
healthcare support services). OSHA relied on these particular plans
to draw its conclusion that it is feasible for employers in typical
firms in the healthcare sector to comply with the requirements in
the ETS for a COVID-19 plan, but only to the extent they address the
implementation of controls to protect workers in job categories
commonly found in workplaces where healthcare services and
healthcare support services are provided (e.g., public facing
employees, general office workers).
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ETS Workplace-Specific Hazard Assessments Required by Different
Healthcare Organizations
Paragraph (c)(4)(i) of the ETS requires healthcare employers to
conduct a workplace-specific hazard assessment to identify potential
workplace hazards related to COVID-19. The workplace-specific hazard
assessment requirements are discussed in detail in Need for Specific
Provisions and Summary and Explanation (Sections V and VIII of the
preamble, respectively).
OSHA conducted a search for existing COVID-19 plans and best
practices developed by employers, trade associations, and other
organizations and posted on their publicly available websites and found
that many required employers to conduct a workplace hazard assessment
to determine the COVID-19 exposure risks to employees. While the
specifics of the assessments may not mirror the full requirements for
OSHA's COVID-19 plans, those hazard assessments indicate and provide
additional support for OSHA's determination that it is feasible for
healthcare employers to design and implement COVID-19 plans. The best
practices also indicate that it is feasible for healthcare employers to
have policies and procedures to regularly check on the proper
implementation of
controls, which corresponds to OSHA's requirement that employers
regularly re-assess the COVID-19 plan to ensure that it is updated and
useful.
The Santa Clara Valley Medical Center (SCVMC) is a 574-bed acute
care, fully accredited public teaching hospital affiliated with
Stanford University Medical School and provides a full range of
inpatient, emergency rehabilitation, neonatal, intensive care, high-
risk maternity care, psychiatry, pediatric intensive care, and burn
intensive care services. The ambulatory outpatient services include
both primary and specialty clinics located not only at SCVMC, but also
at satellite facilities located throughout the area (SCVMC, December 1,
2020).
The SCVMC plans reviewed includes guidelines for COVID-19 exposure
and risk assessment, contact tracing, testing, and return to work for
their employees (SCVMC, December 1, 2020). Furthermore, the COVID-19
plan includes a policy outlining the worker exposure evaluation process
to be conducted by each department and each ambulatory care clinic that
is part of the SCVMC network. The assessment of exposure risk is
required for all individuals working in the SCVMC hospitals and clinics
including employees, volunteer, staff, physicians, contract personnel,
or other workers. The assessment required by the COVID-19 plan should
evaluate physical distancing, period or duration of exposure, as well
as the implementation of controls such as facemasks and respiratory
protection, and other PPE necessary to protect employees from COVID-19
exposure.
OSHA also reviewed the COVID-19 plan for Michigan Medicine, one of
the largest fully accredited academic medical centers in Michigan made
up of the University of Michigan health system and medical school. The
Michigan Medicine COVID-19 plan includes specific requirements for each
department to conduct employee COVID-19 job hazard assessments to
evaluate and mitigate the risk of COVID-19 for University of Michigan
workers (Michigan Medicine U-M, May 18, 2021).
The U-M COVID-19 plan also requires each department to create a
departmental specific COVID-19 work plan for its area to document their
COVID-19 employee job hazard assessment and plan. The plan also
provides departments with resources to develop and implement the
required COVID-19 employee job hazard assessment as well as a
departmental COVID-19 work plan including blank templates for both. The
hazard assessment and subsequent plan required by each department must
evaluate and address for each employee, the ability to maintain
physical distance from all other persons, employee requirements for
facemasks, respiratory protection, and other PPE, hand hygiene and
respiratory etiquette, workplace cleaning and disinfection within the
department or unit. The requirements of the job hazard assessment cover
employees, vendors, contractors, and all other workers performing task
in the department.
Additionally, OSHA reviewed the COVID-19 plan of Johns Hopkins
Medicine, which is made up of the Johns Hopkins University Health
System with six academic and community hospitals, four suburban health
care and surgery centers, over 40 patient care locations, and a home
care group that offers an array of health care services. The Johns
Hopkins Medicine COVID-19 plan includes requirements that assess the
COVID-19 transmission hazards in the workplace to determine the proper
implementation of controls (Johns Hopkins Medicine, 2021). The plan
also includes policies and procedures to implement a daily COVID-19
safety audit program. Each day, the COVID-19 safety auditor ensures
every hospital, outpatient clinic and care center is practicing proper
masking, physical distancing, handwashing and disinfection of
frequently touched surfaces. As with the SCVMC example, this supports
the feasibility of regular reassessments that employers will need to
conduct for their COVID-19 plans.
Based on its review of these plans, OSHA concludes that it is
feasible for employers in typical firms in the healthcare sector to
comply with the requirements in the ETS for a COVID-19 workplace-
specific hazard assessment.
ETS Controls Are Included in Best Practices Recommended by Healthcare
Professional Associations
Some of OSHA's evidence that the COVID-19 plan, distancing,
barriers, and ventilation modifications are feasible for healthcare
employers is that such measures, or substantially similar measures, are
already recommended by some of the largest professional associations in
the healthcare industry.
The American Society for Health Care Engineering (ASHE) is the
largest professional membership group of the American Hospital
Association. The ASHE is comprised of over 12,000 professionals who
design, build, maintain, and operate healthcare facilities. ASHE
members include health care facility managers, control specialists, and
others. ASHE has developed best practices for minimizing the risk from
COVID-19. These best practices can be, and have been, used by ASHE
members' organizations to develop their individual plans. (ASHE,
December 23, 2020)
The ASHE best practices are a collection of strategies which can be
implemented to reduce the spread of COVID-19. The ASHE best practices
recommend a multilayered control strategy. ASHE states that healthcare
organizations are working to maintain physical distance of at least six
feet and one way that this has been achieved is by scheduling check-in
times to limit occupancy as well as other controls such as floor
markings. When physical distancing is not feasible, employers have
installed physical barriers, such as clear, acrylic plexiglass or
vinyl, along with requiring face masks. ASHE also states that
healthcare organizations have taken a combination of approaches for
cleaning and disinfection, such as cleaning workstations including
high-touch surfaces daily. ASHE also discusses health screening and
medical management. According to ASHE, some healthcare organizations
have implemented self-screening policies and procedures, including, for
example, having employees certify that they have not displayed symptoms
or been in recent contact with someone that has tested positive for
COVID-19. Finally, the ASHE best practices recommend ensuring that
ventilation systems are working properly, including ensuring that all
negative pressure spaces including AIIRs are properly maintained, and
that the circulation of outdoor air is increased as much as possible.
The ASHE best practices also provide employers with steps to verify
that CDC recommended guidelines for air changes and time required for
contaminate removal based on air changes are followed.
The American Health Care Association and the National Center for
Assisted Living (AHCA/NCAL), an association representing long term and
post-acute care providers, with more than 14,000 member facilities
including non-profit and proprietary skilled nursing centers, assisted
living communities, sub-acute centers and homes for individuals with
intellectual and development disabilities, has also developed best
practices for minimizing the risk from COVID-19 (AHCA/NCAL, 2021).
Similar to the ASHE best practices and other plans and best practice
documents that were reviewed, the AHCA/NCAL best practices contain many
of the controls that are required
by the ETS. Also similar to the ASHE and other best practice documents,
the AHCA/NCAL membership can use the AHCA/NCAL best practices to
develop their individual plans. For example, the AHCE/NCAL best
practices recommend implementing controls to maintain physical distance
including rearranging offices and workstations as needed, posting signs
and floor markers, and limiting the number of individuals permitted in
the workplace. In addition, the AHCA/NCAL best practices recommend the
use of facemasks and increased cleaning and disinfection. The best
practices also contain recommendations on health screening and medical
management. Members have implemented recommendations on self-
questionnaire policies and procedures for employees and all other
individuals before they can enter the site, including, for example,
recommendations on having employees certify that they have not
displayed symptoms or been in recent contact with someone that has
tested positive for COVID-19. The AHCE/NCAL best practices also contain
recommendations on conducting contact tracing while protecting the
employee's identity, and engaging in facility-wide protocols to protect
other employees.
The New Mexico EMT Association (NMEMTA) is a professional
organization supporting emergency medical technicians and others
serving the public in the emergency services sector (NMEMTA, March 29,
2020). Similar to other best practice documents that were reviewed, the
NMEMTA best practices contain many of the controls that are required by
the ETS and recommend a multilayered approach to infection control.
Furthermore, NMEMTA members can use this guidance to develop their
individual plans. The NMEMTA best practices recommend implementing
physical distancing controls when responding to an emergency as well as
when transporting patients. For example, NMEMTA provides guidance on
limiting the number of responders by implementing policies for
coordinating with dispatchers prior to initial assessment, and
additional work practices such as using radio communications to
minimize the number of responders on scene. Additionally, the NMEMTA
best practices recommend policies and procedures to limit the number of
EMS workers in the ambulance and provide guidance on installing
physical barriers to separate the driver from the treatment area of the
ambulance. The NMEMTA best practices also recommend policies for
requiring the proper PPE and respiratory protection for EMS employees
as well as for placing facemasks on patients and family members
traveling in the ambulance.
The National Association for Home Care & Hospice (NAHC) is a
nonprofit organization that represents the nation's 33,000 home care
and hospice organizations. NAHC also advocates for the more than two
million nurses, therapists, aides, and other caregivers employed by
such organizations to provide in-home services to some 12 million
Americans each year who are infirm, chronically ill, or disabled (NAHC,
March 3, 2020). NAHC developed best practices for home health and
hospice employers. The NAHC best practices recommend a multilayered
infection control plan to protect employees from COVID-19. These best
practices include strategies for maintaining physical distance,
including ways to limit instances where caregivers are within 6 feet of
other persons. For example, the NAHC best practices contain policies
for requiring household members to stay in separate rooms of the home
as much as possible and to maintain at least 6 feet of distance from
the caregiver when they must be in the same room. In addition, the best
practices recommend procedures to ensure the home space has good air
flow via an HVAC system or by opening windows and doors during the
visit. The best practices also provide guidance on implementing
protocols for performing hand hygiene and cleaning and disinfection of
the workspace, tools, equipment and other high touch surfaces. The best
practices also recommend requirements for the use of facemasks,
respirators, and other PPE for home health and hospice caregivers,
patients, and members of the household during the home visit.
Additionally, the best practices provide strategies for the
implementation of patient telehealth, as well as self-screening before
visits to prevent employee exposure to known or suspected COVID-19
patients without taking appropriate precautions (e.g., PPE and
respirators).
Examples of Existing Healthcare Employer Plans and Controls
OSHA also reviewed a number of existing plans prepared by hospitals
and other healthcare providers that also illustrate that employers in
the healthcare sector have implemented a multilayered approach to
protect their workers from COVID-19. MedStar Health, a not-for-profit
community health system comprised of physician offices, urgent care
centers, regional ambulatory care centers, and 10 community hospitals,
has developed and implemented a COVID-19 plan (MedStar, May 5, 2021).
The plan adopts a multilayered approach to protect workers from COVID-
19 across MedStar's facilities and contains many of the provisions also
required by the ETS. For example, MedStar requires controls to ensure
physical distancing, including, for example, restricting the entry of
visitors and non-essential employees to reduce occupancy. Additionally,
MedStar requires the use of facemasks by employees, patients, and
visitors. MedStar also requires employees to self-screen and monitor
for signs and symptoms of COVID-19 and for visitors to utilize the
telephone triage system when scheduling visits to isolate known or
suspected cases of COVID-19 infection. Finally, MedStar requires
cleaning and disinfection of the workplace daily, as well as hand
hygiene protocols before, during, and after all appointments and
procedures.
Other employer plans reviewed also adopt a multilayered approach to
COVID-19 protection (see, e.g., Cambridge Health Alliance, 2021; Johns
Hopkins Medicine, 2021; HCA Healthcare, 2021; Dignity Healthcare,
2021). With respect to physical distancing, employer plans include
strategies to reduce and restrict occupancy at facilities. For example,
employers have implemented staggered shifts for employees, as well as
teleworking arrangements, to help reduce occupancy and ensure physical
distancing. Employers have also expanded remote telemedicine
consultations so fewer patients with non-emergency conditions need to
visit hospitals and other facilities where patient care occurs to
receive medical care. In this respect, where video conferencing systems
cannot be used, employers have used other virtual options, such as
online secured patient portals with chat and messaging features, to
reduce the occupancy of healthcare facilities. Employers have also
implemented telephone triage systems, and, in this way, patients
identified as low risk for COVID-19 can be cared for virtually, if
appropriate, while patients identified as higher risk for COVID-19 can
be routed to the appropriate care. In addition, employers have reduced
or completely eliminated patient visiting hours for those patients with
suspected or confirmed COVID-19. Finally, employers have installed
floor markings as visual cues to stay six feet apart throughout the
facility, including common areas such as waiting rooms and cafeterias,
spaced public seating six
feet apart, and limited the number of people in a space, whenever
possible.
The employer plans cited above also include policies and procedures
for the installation of physical barriers to protect workers outside of
direct patient care areas when physical distancing may not be possible
at all times. For example, some hospitals have installed physical
barriers at checkpoints, to protect security guards, as well as at
reception desks and patient/visitor information counters, to protect
the employees working there, from exposure to visitors, patients, and
co-workers.
The employer plans reviewed also include policies and procedures
for the use of facemasks. Moreover, the plans include policies on
increased cleaning and disinfection. For example, the plans include
requirements that surfaces and equipment are thoroughly cleaned and
disinfected daily using products that are effective against COVID-19.
The plans also include policies on maintaining HVAC systems and using
system filters with a MERV rating of 13 or higher, as well as polices
for pre-screening patients and employees for COVID-19 (including
requirements for self-questionnaires designed to identify anyone who
has or is suspected to have COVID-19 before their arrival at the
facility).
OSHA has determined that developing a COVID-19 plan, as required by
the ETS, is feasible based on the evidence that employers in the health
care sector have developed plans that address many of the requirements
of the ETS. Additionally, national trade associations and other
organizations in the health care sector have developed best practices
to aid in the development of these plans (ERG, February 9, 2021). As
discussed in the Summary and Explanation (section [VIII]), the plan
must address the hazards identified per the hazard assessment required
by paragraph (c)(4) of the ETS and the employer must do regular
inspections to ensure ongoing effectiveness of the plan and update as
needed.
b. Implementation of Good Infection Control Practices
The ETS contains four provisions for good infection control
practices, each of which is discussed in detail in Need for Specific
Provisions and Summary and Explanation (Sections V and VIII of the
preamble, respectively):
Sec. 1910.502(d)--Patient screening and management. The purpose of
this provision is to limit contact with potentially infectious persons
by, for example, requiring screening and triage of everyone entering a
healthcare setting and limiting and monitoring points of entry to the
setting.
Sec. 1910.502(e)--Standard and transmission-based precautions. The
ETS requires that, in settings where healthcare services, healthcare
support services, are provided, the employer must develop and implement
policies and procedures to adhere to Standard and Transmission-Based
Precautions. Standard and Transmission-Based Precautions are
established and commonly used practices for reducing the risk of
transmission of infectious agents such as COVID-19.
Sec. 1910.502(f)--Personal protective equipment (PPE). The ETS
requires employers to provide and ensure employees use facemasks or
respirators in specified situations, and also requires the use of other
PPE, such as gloves and eye protection, in appropriate circumstances.
Sec. 1910.502(g)--Aerosol-generating procedures on a person with
suspected or confirmed COVID-19. Because aerosol-generating procedures
are known to be high risk activities for exposure to respiratory
infections such as COVID-19, the ETS contains special requirements to
address this hazard. For example, the employer must limit the number of
employees present during the procedure to only those essential for
patient care and procedure support.
Some of these controls are obviously feasible simply because of the
nature of the control. The process of screening, for example, can
typically be accomplished simply through questioning, so there are no
technological feasibility barriers to implementing those controls. To
support its assessment of the technological feasibility of other
controls in the ETS, OSHA reviewed evidence that shows that the
healthcare-specific good infection control practices identified in
Sec. 1910.502(d) through (g) are commonly implemented by employers who
have employees in healthcare settings. This evidence includes: CDC
infection control guidance documents, many of which are COVID-19
specific; regulations issued by the Centers for Medicare & Medicaid
Services (CMS); and accreditation of these settings by The Joint
Commission; and OSHA's Bloodborne Pathogens (BBP) Standard, 29 CFR
1910.1030. For example, Sec. 1910.502(e) requires compliance with the
CDC's Standard and Transmission-Based Precautions. As detailed below,
OSHA can show that this is technologically feasible by demonstrating
that at least some hospitals and other healthcare settings follow these
precautions (thereby showing it is capable of being done and can be
implemented in other healthcare settings).
To demonstrate that, OSHA points to two reasons why healthcare
employers comply with these precautions. First, OSHA's BBP standard
already requires hospitals and other healthcare facilities to implement
a parallel framework, often with similar systems and controls, to
comply with many of the same precautions. Even where the requirements
for some controls must be implemented somewhat differently under this
ETS than under the BBP standard, OSHA is not aware of technological
feasibility challenges that arise from these differences. For example,
a hospital's COVID-19 plan will be different from its BBP Exposure
Plan, but the planning process will already be familiar to the hospital
and there should be enough similarities in the construction of plans
identifying and addressing hazards that there will not be any
feasibility issues with formulating the COVID-19 plan.
Second, healthcare employers must have an infection control program
that includes Standard and Transmission-Based Precautions to be
eligible for certain government funds (CMS distribution of Medicare and
Medicaid funds) or accreditation (The Joint Commission). CMS
regulations only cover providers that accept or collect payments from
Medicare or Medicaid. Compliance with the CMS regulations is generally
validated through periodic accreditation surveys of facilities by CMS-
approved accreditation organizations, including The Joint Commission,
state survey agencies, and other accrediting organizations (e.g.,
Accreditation Association for Ambulatory Health Care (AAAHC)). CMS and
The Joint Commission reliance on largely the same criteria as this ETS
means that the technological feasibility of the ETS is supported by
those hospitals and other healthcare settings who do have to comply by
proving that the requirements are capable of being done.\28\
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\28\ OSHA notes that its assessment in this section addresses
only whether the ETS is technologically feasible. The fact that many
health care facilities have already implemented some version of the
controls required by the ETS does not mean that there is no need for
the ETS to apply to healthcare. Again, CMS regulations only cover
providers that accept or collect payments from Medicare or Medicaid.
In addition, OSHA has in place enforcement mechanisms that CMS does
not have and that would work in concert with CMS to achieve a
greater level of compliance. For example, OSHA can respond to
complaints, conduct random unannounced inspections, and conduct
worksite inspections in response to complaints filed by workers. As
described elsewhere in this preamble, the ETS is necessary to
address the grave danger posed by COVID-19. See Rationale for the
ETS, Grave Danger and Need for the ETS (Section IV of the preamble).
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CDC Infection Control Guidance Documents
The CDC has issued infection control guidance, listed in Table
VI.A.-3, that apply to the following settings and industry groups:
Hospitals and ambulatory care, plasma and blood collection facilities
and dialysis facilities, home health care, emergency responders and
prehospital care, autopsies, long-term care, and dental and oral care.
These guidelines provide infection-control recommendations for use in
the settings covered by the ETS (listed in Table VI.A.-3). The guidance
provides recommendations for implementing policies and practices to
minimize the risk of exposure to respiratory pathogens, and many are
recently issued guidelines specific to COVID-19.
BILLING CODE 4510-26-P
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BILLING CODE 4510-26-C
The CDC guidelines in Table VI.A.-3 are commonly implemented,
longstanding, and essential elements of infection control in healthcare
settings (i.e., the settings listed in Table VI.A.-1), evidenced by the
CDC's 2007 Guideline for Isolation Precautions: Preventing Transmission
of Infectious Agents in Healthcare Settings (Item 8 in Table VI.A.-3,
above), which incorporates Standard and Transmission-Based Precautions
into its recommendations. This 2007 Guideline updated 1996 guidelines,
which introduced the concept of Standard Precautions, and also noted
the existence of infection control recommendations dating back to 1970.
The implementation of the CDC guidelines is also evidenced by
regulations issued by the Centers for Medicare & Medicaid Services
(CMS) that apply to settings in Table VI.A.-1 and the accreditation of
settings in Table VI.A.-1 by The Joint Commission, as described below.
OSHA notes that guidelines that are grouped with one setting in
Table VI.A.-1 may apply to other settings as well. For example, the
Interim Infection Prevention and Control Recommendations for Healthcare
Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic (Item
1 in Table VI.A.-3) applies to Emergency Medical Personnel, Home Health
Care, and Long-Term Care, in addition to applying to Hospitals and
Ambulatory Care.\29\
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\29\ The guidance is applicable to all U.S. settings where
healthcare is delivered, and defines ``healthcare setting'' as
places where healthcare is delivered. According to the guidance,
this includes acute care facilities, long-term acute care
facilities, inpatient rehabilitation facilities, nursing homes and
assisted living facilities, home healthcare, vehicles where
healthcare is delivered (e.g., mobile clinics), and outpatient
facilities, such as dialysis centers, physician offices, and
others.'' Moreover, the guidance defines ``healthcare personnel,''
or HCP, as all paid and unpaid persons serving in healthcare
settings who have the potential for direct or indirect exposure to
patients or infectious materials, including body substances (e.g.,
blood, tissue, and specific body fluids); contaminated medical
supplies, devices, and equipment; contaminated environmental
surfaces; or contaminated air. According to the guidance, HCP
include emergency medical service personnel, nurses, nursing
assistants, home healthcare personnel, physicians, technicians,
therapists, phlebotomists, pharmacists, students and trainees,
contractual staff not employed by the healthcare facility, and
persons not directly involved in patient care, but who could be
exposed to infectious agents that can be transmitted in the
healthcare setting (e.g., clerical, dietary, environmental services,
laundry, security, engineering and facilities management,
administrative, billing, and volunteer personnel).
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CMS Regulations That Condition Participation in Medicare and Medicaid
on Implementation of Nationally Recognized Infection Control Guidelines
The Centers for Medicare & Medicaid Services (CMS) administers
healthcare programs for the elderly (Medicare) and needs-based state
programs that help with medical costs (Medicaid). As a condition for
participation in Medicare or Medicaid, medical providers must comply
with regulations issued by the Department of Health and Human Services
(DHHS), 42 CFR Pts. 400-699. A number of these regulations, which apply
to a broad spectrum of the settings listed in Table VI.A.-1, condition
participation in Medicare and Medicaid on the implementation of
nationally recognized infection control practices like the CDC
guidelines listed in Table VI.A.-3. The applicable CMS regulations are
summarized in Table VI.A.-4.
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Accreditation by The Joint Commission
Founded in 1951, The Joint Commission is an independent, not-for-
profit organization that accredits and certifies more than 22,000
healthcare organizations and programs in the United States (The Joint
Commission, 2021a). Joint Commission accreditation and certification is
recognized nationwide as a symbol of quality that reflects an
organization's commitment to meeting certain performance standards.
Joint Commission standards are the basis of an objective evaluation
process that can help healthcare organizations measure, assess and
improve performance. The standards focus on important patient,
individual, or resident care and organization functions that are
essential to providing safe, high-quality care (The Joint Commission,
2021b). To maintain accreditation, organizations undergo an on-site
survey by a Joint Commission survey team at least every three years
(laboratories are surveyed every two years). In these surveys, The
Joint Commission monitors compliance with its standards for the
implementation of good infection control and biosafety practices
(including, for example, adherence to Standard and Transmission-Based
Precautions, as recommended by the CDC Guidelines in Table VI.A.-3)
(The Joint Commission, 2021c). The Joint Commission offers
accreditation for the following settings (many of which are contained
in Table VI.A.-1) (The Joint Commission, 2021c):
Ambulatory care facilities;
Critical access hospitals;
Behavioral health care;
Hospitals;
Home care services;
Nursing care centers; and
Office-based surgery centers.
OSHA's Bloodborne Pathogens Standard, 29 CFR 1910.1030
Employers subject to the ETS have also been subject to requirements
in the Bloodborne Pathogens (BBP) standard for 30 years, since it was
promulgated in 1991. As the BBP standard was promulgated, OSHA found
``with
respect to the technological feasibility of the standard that its
provisions permit practical means to reduce the risk now faced by those
employees working with blood and other infectious materials and that
there do not appear to be any major obstacles to implementing the
rule.'' (56 FR 64004, 64039 (Dec. 6, 1991)). OSHA's finding of
technological feasibility during the BBP standard rulemaking is
additional evidence that there are no technological feasibility
barriers to complying with the ETS.
For example, Standard Precautions, which are required by the ETS,
are similar to, but more extensive than, ``Universal Precautions'',
which are required by the BBP standard to prevent contact with blood or
other potentially infectious materials (see definitions in the BBP
standard). The BBP standard defines ``Universal Precautions'' as an
approach to infection control wherein all human blood and certain human
body fluids are treated as if known to be infectious for HIV, HBV, and
other bloodborne pathogens. Standard Precautions were developed to
integrate principles of Universal Precautions into broader principles
pertaining to routes of exposure other than the bloodborne route, such
as via the contact, droplet, or airborne routes. For example, although
the BBP standard might not apply, Standard Precautions would be
utilized when workers are exposed to urine, feces, nasal secretions,
sputum, vomit, and other body fluids, and also when workers are exposed
to mucous membranes and non-intact skin. Using Standard Precautions
when there is exposure to these materials, it should be assumed that
the materials potentially contain infectious agents that could be
transmitted via the contact, droplet, or airborne routes. Standard
Precautions not only include the infection control methods specified as
Universal Precautions (e.g., hand hygiene, the use of certain types of
PPE based on anticipated exposure, safe injection practices, and safe
management of contaminated equipment and other items in the patient
environment), but also include, for example, respiratory and cough
etiquette. The respiratory and cough etiquette and other additional
controls for Standard Precautions are minor expansions on the Universal
Precautions already applicable to most healthcare facilities, and OSHA
is not aware of any technological barriers for employers subject to the
ETS.
In addition to the above requirements, the BBP standard contains
requirements for an exposure control plan, engineering and work
practice controls, hand hygiene, personal protective equipment,
housekeeping (e.g., cleaning and decontamination), and vaccination,
which all have corollaries in the ETS. While there are differences
between the BBP standard and the ETS, there is overlap. For example,
although the requirements for a COVID-19 plan in the ETS are different
than those for the exposure control plan required by the BBP standard,
the process for developing and implementing these plans should be
similar. Based on this overlap, there should not be any technological
feasibility barriers to complying with the corollary provisions in the
ETS.
c. Physical Distancing and Physical Barriers
Physical Distancing: The ETS (paragraph (h)) requires the employer
to ensure that each employee is separated from all other people by at
least 6 feet unless the employer can demonstrate that such physical
distancing is not feasible for a specific activity, and that, when the
employer establishes it is not feasible for an employee to maintain a
distance of at least 6 feet from all other people, the employer must
ensure that the employee is as far apart from all other people as
feasible.
Physical Barriers: The ETS (paragraph (i)) requires that at each
fixed work location outside of direct patient care areas where an
employee is not separated from all other people by at least 6 feet of
distance, the employer must install cleanable or disposable solid
barriers, except where the employer can demonstrate it is not feasible
(or the paragraph (a)(4) exception for vaccinated employees applies).
As discussed above, OSHA reviewed a number of plans and best
practice documents developed and employed by the healthcare sector to
reduce the risk of COVID-19 exposure. These plans included
recommendations and requirements for the implementation of physical
distancing and physical barriers in the settings covered by the ETS.
These plans and best practice documents provide strong evidence that it
is technologically feasible to implement these controls in the
healthcare sector. Moreover, OSHA developed physical distancing
scenarios and a job matrix spreadsheet, discussed below, which also
provide strong evidence that the implementation of physical distancing
and physical barriers is technologically feasible in the healthcare
sector.
Physical Distancing Scenarios
OSHA developed ``physical distancing'' scenarios for a variety of
workplaces covering a wide range of situations to describe the controls
that have been put in place to maintain not only physical distancing
but also physical barriers at each fixed work location outside of
direct patient care areas (e.g., entryway/lobby, check-in desks,
triage, hospital pharmacy windows, bill payment), as well as other
controls required by the ETS as part of a multilayered strategy to
reduce or eliminate the transmission of SARS-CoV-2. As OSHA discusses
in more depth below, these scenarios are based primarily on COVID-19
plans developed by employers.
OSHA uses these scenarios (and by extension the plans on which they
are based) to support its feasibility determination regarding the
physical distancing and physical barrier requirements of the ETS, and
also to show that other controls required by the ETS are being, or can
be implemented, by typical employers across affected workplaces.
OSHA also uses these scenarios to explore ways to mitigate the
remaining risk of exposure when it is infeasible to comply with the
requirements for physical distancing. While this portion of the
analysis falls outside the pure examination of the technological
feasibility of the required controls, it is intended to demonstrate the
steps that employers are expected to take to reduce exposure risk. Some
of the plans that OSHA consulted in developing these scenarios include
examples of controls that would not meet the requirements of the ETS,
but OSHA has attempted to incorporate some of these examples into the
scenarios while noting that some of the controls may only be used when
the other controls are infeasible.
Thus, for example, some scenarios describe the use of both physical
distancing and physical barriers by employers. OSHA's description of
the scenarios below should not be read to mean that OSHA sanctions the
use of physical barriers in lieu of physical distancing, when physical
distancing is feasible. For an in-depth discussion on the rationale
underlying OSHA's rulemaking decisions, please see Need for Specific
Provisions (Section V of the preamble).
As another example, some scenarios describe facemasks, ventilation,
and other controls required by the ETS as additional controls when
physical distancing is not feasible. But these controls are not
alternatives to physical distancing under the ETS. Again, physical
distancing (or physical barriers at fixed workstations outside of
direct patient care areas, when physical distancing is not feasible)
must be
implemented alongside these controls under the ETS as part of a
multilayered approach to infection control.
Finally, OSHA emphasizes that physical distancing is feasible for
the vast majority of situations employers may face in their daily job
duties. There are a select number of situations where physical
distancing is not feasible, and for these situations, employers must
implement physical barriers if feasible at fixed work locations outside
of direct patient care areas. And, again, employers must implement the
other controls as required by the standard (e.g., facemasks, and
respirators, cleaning and disinfection, health screening and medical
management, employee notification).
In reviewing the record, OSHA found that, while exposure to COVID-
19 can occur from contact with co-workers or the public as part of
healthcare workers' job duties in a wide range of workplaces covered by
the ETS, many of the processes and controls used to minimize risk are
the same or similar.
The physical distancing scenarios OSHA's contractor--a safety and
health subject matter expert--developed include examples of policies
and procedures implemented to maintain physical distancing, physical
barriers, and other controls based on a review of guidance and existing
pandemic plans and other sources. This information was supplemented
where needed with additional internet searches, for instance, from news
articles, industry surveys, or articles in industry publications that
demonstrate how companies in different industries have been
implementing physical distancing. The contractor also relied on its
professional expert judgment (ERG, February 25, 2021). The scenarios
identify groups of workers who face similar work situations with regard
to physical proximity (within 6 feet) of another person (e.g.,
visitors, members of the public), and for whom the same or similar
precautions to limit physical proximity can be implemented. In this
respect, some of the evidence on which OSHA relies in this assessment
(with respect to the offices, law enforcement, security guards, and
protective services, home healthcare, personal care, and companion
service providers, and postmortem services scenarios) rely on plans and
best practices from both industries affected by this ETS and other
industries not affected by the ETS. In analyzing the evidence of
physical distancing and barriers across multiple industry sectors, OSHA
observed that the feasible methods of implementing physical distancing
and physical barriers for employees with similar exposures was similar
regardless of industry (for example, employing physical distancing and
barriers to protect administrative and clerical staff, receptionists,
those who are exposed to human remains, and those who enter personal
residences to provide care). To this end, OSHA's assessment of the
feasibility of implementing physical distancing and physical barriers
in the healthcare section is based on evidence from other industries to
the extent that workers share similar job roles and perform similar job
tasks such that the feasibility of distancing and barriers would be the
same in either case.
OSHA also developed a job matrix spreadsheet to identify groups of
workers facing similar work situations. To develop this spreadsheet,
OSHA first found and reviewed 418 plans from employers representing
various separate 3-digit North Industry Classification System (NAICS)
codes, and 286 best practice documents from trade associations and
other organizations covering 46 3-digit NAICS codes (ERG, February 9,
2021). As part of the review, OSHA included plans and best practices
from industries outside of healthcare to clearly demonstrate the
feasibility of implementing a multilayered approach to COVID-19
infection control (including facemasks and the installation of physical
barriers where distancing is not feasible) for similar work situations.
Next, OSHA identified unique job categories across the industry
sectors with many categories present across multiple NAICS codes. These
job categories were cross-referenced with the scenarios to develop the
job matrix spreadsheet (February 25, 2021). This job matrix spreadsheet
was used to identify job categories facing similar situations regarding
the ability to maintain physical distance with coworkers and/or members
of the public. OSHA expects that, for these situations, employers can
implement the same or similar precautions, for not only limiting
physical proximity, but also for the other multilayered controls
required by the ETS. Workers with public-facing job duties, such as
receptionists and security guards, share many of the same or similar
exposure control challenges, and employers of these job categories over
a wide variety of industry sectors have implemented similar
multilayered controls such as physical distancing, the installation of
barriers, requirements for face masks, and hand hygiene, among others,
as discussed below (February 25, 2021). OSHA concludes, based on the
job matrix that evidence of feasibility for one scenario also
establishes feasibility for other scenarios to the extent job
categories cut across scenarios.
The scenarios OSHA developed for the healthcare sector are listed
in Table VI.A.-5.
[GRAPHIC] [TIFF OMITTED] TR21JN21.008
Below, OSHA highlights some of the elements of these scenarios and
portions of the job matrix on which it relied. In the discussion below,
OSHA will first describe some of the types of jobs workers conduct in
most workplaces in the scenarios discussed (or across scenarios to the
extent this is supported by the job matrix), and identify some of the
unique work processes that are already conducted in a physically
distanced manner or that can be easily modified to avoid or reduce
physical proximity for each scenario discussed (or, as applicable,
across scenarios). OSHA then describes some of the discrete activities
where physical contact with others (i.e., the public or other workers)
may be necessary or unavoidable, along with the precautions and
controls that can still feasibly be implemented for the scenarios (or,
as applicable, across scenarios) as part of a multilayered approach to
protection, such as facemasks, ventilation, and the use of physical
barriers.
In this respect, OSHA's analysis found employers have implemented
physical barriers at fixed work locations outside of direct patient
care areas (e.g., entryway/lobby, check-in desks, triage, hospital
pharmacy windows, bill payment). Physical barriers are required as part
of the multi-layered approach to infection control that is at the heart
of the ETS. As discussed more fully in the Need for Specific Provisions
(Section V of the preamble), physical barriers, when properly
installed, are effective at intercepting respiratory droplets and
minimizing the risk of exposure to COVID-19, especially in areas where
employees cannot maintain a minimum of 6 feet of distance from
coworkers, customers, and members of the general public.
The ETS does not specify the type of material that must be used for
physical barriers, but the material must be impermeable to infectious
droplets that are transmitted when an infected individual is sneezing,
coughing, breathing, talking, or yelling. In addition, physical
barriers must be made from materials that can be easily cleaned and
disinfected unless in lieu of cleaning the employer may opt to replace
the barrier. Using replaceable materials would allow an employer to
dispose of and replace barriers between uses, instead of cleaning and
disinfecting more permanent barriers. The effective design and
implementation of physical barriers will differ among workplaces based
on job tasks, work processes, and even potential users. Physical
barriers must be designed, constructed, and installed to prevent
droplets from reaching employees when they are in their normal sitting
or standing location relative to the workstation. For example, under
the provision, plastic sheeting can qualify as a physical barrier only
in situations where it is fixed in place and blocks face-to-face
pathways of air between the users on either side while those workers
are performing all of their assigned tasks.
Examples of physical barriers across a variety of workplaces are
discussed in the scenarios below. Further considerations for the design
and implementation of physical barriers to properly block face-to-face
pathways of breathing zones, including whether plastic sheeting, films,
curtains, and other non-rigid materials are acceptable materials, as
well as installation, are discussed in the summary and explanation of
Physical Barriers.
Employers subject to the ETS share a common challenge: Finding ways
to limit physical proximity (of less than 6 feet) between each worker
and other workers, as well as visitors and other non-employees in the
workplace. In the limited situations where physical distancing is not
feasible, employers often face similar challenges and employ similar
solutions in designing and installing physical barriers to help protect
their employees, even though the types of products or services they
offer or the work they do vary. For example, employers often install
physical barriers with a pass-through space at the bottom.
A barrier is thus an effective tool in helping to protect a
security guard at a check point at a hospital's entrance, a
receptionist in the billing department, and any other public-facing
employee. Physical barriers have also been installed to shield
healthcare workers and others from individuals with suspected or
confirmed COVID-19 (for example in triage areas of an emergency
department). Employers have also installed barriers between urinals and
sinks in restrooms both as separations between persons using the
facility and as a splash guard (ERG, February 9, 2021; ERG, February
25, 2021).
As the assessment below makes clear, OSHA has found no feasibility
issues with the implementation of physical distancing or physical
barriers in typical operations in the healthcare sector.
General Office Settings
General office settings are common across a number of industry
sectors, and many healthcare facilities have areas
with administrative offices similar to general office settings. OSHA
developed a physical distance scenario for offices by identifying
industry sectors where office worksites are common. OSHA found that
employers have successfully implemented a variety of physical
distancing measures (measures to keep people 6 feet apart) by
incorporating administrative and engineering controls for the various
job categories that work in offices such as supervisors and managerial
staff, administrative and clerical staff, and receptionists.
Administrative and clerical workers are a common job category
within office worksites across a wide variety of industries. In
addition to the offices scenario, administrative and clerical workers
were identified in a number of other physical distancing scenarios
including: Law enforcement, security guards, and protective services;
postmortem care; and long-term care (although OSHA believes
administrative and clerical workers likely work within most scenarios,
given that administrative and clerical work is usually necessary
regardless of industry sector).
A number of strategies for maintaining physical distancing as part
of a multilayered approach have been implemented for administrative and
clerical staff, including establishing remote work, altering the work
environment to limit the number of chairs and workstations, relocating
workers to locations that ensure proper physical distancing, and
arranging visitor seating areas to be at least 6 feet away from
employees' desks. Employers can also adopt telehealth services to
completely isolate clerical and administrative staff from the patients,
clients, and other people they might otherwise be interacting with in
person. Meetings can be conducted virtually, or conference tables and
chairs can be relocated to areas of the office where physical
distancing can be ensured. Employers may also establish occupancy
limits for certain rooms (e.g., bathrooms, breakrooms, elevators,
lunchrooms, and changing areas), stagger breaks to limit the number of
workers on break at the same time, and use signs and markings to
communicate occupancy limits and to remind workers to keep 6 feet
apart. Shared equipment, such as copiers or printers, can also be
located more than 6 feet apart so that different employees can use that
equipment at the same time without having to be close to each other.
OSHA notes that many supervisors and managers (e.g., hospital
administrators) have many of the same types of exposures as
administrative and clerical staff. They commonly work in communal
office areas, engage in collaborative group work, and hold office
meetings in conference rooms. Moreover, as supervisors and managers,
they implement the physical distancing strategies described above for
the facilities where they work, and not just to apply to administrative
and clerical staff.
While receptionists are a common job category within office
worksites, they are also employed in a variety of industry sectors.
Receptionists are public-facing employees and their jobs include tasks
which routinely put them in contact with the public, such as greeting
and directing patients and families appropriately, responding to
inquiries, coordinating with first responders or law enforcement,
working with patients to process medical billing and paperwork, and
maintaining security and telecommunications systems.
OSHA identified a number of physical distancing strategies that
have been commonly used to increase physical distancing for
receptionists. When telework is not possible, employers have eliminated
reception seating areas, closed lobbies, and required patients and
visitors to phone or text ahead for entry into the workplace. In
addition, signs and floor marks indicating 6-foot spaces where lines
can form in reception areas have been found to help maintain physical
distance between visitors and receptionists. When limiting access to
reception areas is difficult, employers have reduced occupancy by only
allowing seating at every other chair in waiting areas. Touchless or
remote payment and scheduling options have been successfully used to
limit face-to-face interactions with customer clients.
As discussed above there are many options of potential controls to
provide physical distancing for supervisors and managers,
receptionists, administrative and clerical workers, and other office
workers who work in office settings. However, there may be limited
instances where employees might be unable to physically distance all of
the time. As part of a multilayered approach to transmission control,
physical barriers have been installed in office settings across all
industry sectors. For example, workers in office settings (e.g.,
medical billing and financial service, transcription, and medical
records departments) often spend the majority of the day at their desks
or other fixed workstations. For these situations, employers have
installed plexiglass barriers or partitions between workstations and
between public-facing staff and patients, families, customers, clients,
and other non-employees. At public facing workstations, physical
barriers with small openings have been installed to enable the passing
of paperwork and payment machines, for example. Under the ETS, when it
is not feasible for employees to be properly distanced from each other,
barriers must also be installed between the employees.
Law Enforcement, Security Guards, and Protective Services
A physical distance scenario developed particularly for law
enforcement, security guards, and protective services identified a
number of industry sectors where job categories within the scenario are
common. OSHA found that employers of security guards have successfully
implemented a variety of physical distancing controls to maintain 6
feet of physical distance from other people.
Common physical distancing controls for security guards include
staggering work shifts and limiting or ending in-person meetings. The
use of walk-through metal detectors instead of hand-held wands and
electronic mobile credentials to avoid the need for security officers
to physically check individuals have also been implemented (if wands
are used, the person being wanded should face away from the security
guard). Electronic mobile credentials can also be centrally managed
from a remote location, limiting the need for personnel to visit
badging offices. Employers have utilized signs, floor markings, and
ropes to mark a 6-foot distance around security guard stations to
remind people who are standing in line to maintain appropriate distance
from the security officer and other people in line.
As part of a multilayered approach to transmission control,
employers have also installed physical barriers to protect these
workers when they are at fixed workstations. Across healthcare
workplaces, employees working in security checkpoints are commonly
unable to maintain physical distance from non-employees who need to be
checked-in or are waiting in line (for example, during identification
screenings at hospital entrances). In such circumstances, the
installation of barriers helps protect security personnel interacting
with the public.
Emergency Medical Services
OSHA developed a physical distancing scenario for Emergency Medical
Service (EMS) organizations. EMS workers cover a number of job
categories including emergency medical
technicians (EMTs), paramedics, and cross-trained firefighters serving
in the capacity of paramedics or EMTs.
OSHA identified a number of common physical distancing controls
implemented by EMS providers, which limit the number of onsite workers
within physical proximity of patients and others, and also limit crowd
size during emergency response. First, to limit the number of EMS
workers that respond to a call to those absolutely necessary, EMS
employers have implemented polices to coordinate with the emergency
response operator (e.g., the 911 operator/dispatcher) on how many EMS
responders are needed. Also, employers have implemented policies to
ensure that the emergency response operator coordinates with law
enforcement to disburse or move unnecessary people before the ambulance
arrives. Additionally, employers have instituted work practices where
one EMS worker conducts the initial patient evaluation and performs
medical treatment, remaining in radio communication with the other EMS
worker, who will enter to assist only if necessary. EMS employers have
also instituted policies to limit the number of workers in the
ambulance to those who are medically necessary and to encourage family
members to follow the ambulance in their own vehicle rather than riding
in the ambulance.
EMS workers cannot always avoid proximity to coworkers or patients
during some operations including, for example, engaging in emergency
medical care, transporting patients in ambulances, and transferring
patients to healthcare facilities. When EMS workers respond to an
emergency, they are involved in evaluating and treating the patient
onsite before transporting the patient as necessary. EMS workers may
need to work as a team in order to perform some tasks (e.g., while
performing cardiopulmonary resuscitation (CPR) and using a bag valve
mask also known as an Ambu bag). In addition, arriving EMS workers
could be within 6 feet of people at the site, including family members
and the general public who may have gathered.
Employers of emergency medical services (EMS) workers have
installed physical barriers to protect their workers in at least some
of these situations. For example, physical barriers are often installed
between the workstations of emergency response operators, who assist in
coordinating the response to emergency situations (e.g., for the EMS
system or the public health system, and in 911 call centers or
healthcare facilities). Employers have also installed physical barriers
between the treatment compartment of ambulances and the driver's
compartment to protect drivers and other workers who need not be
exposed to patients.
OSHA also identified a number of strategies that have been used by
EMS providers as part of a multilayered approach to infection control.
Employers have implemented policies for requiring employees to wear
appropriate respiratory protection and other PPE, placing a face
covering or facemask on the patient when possible, and requiring family
members to wear face coverings or leave the area while EMS workers
respond to emergencies in patient homes. In addition, employers have
instituted protocols for moving a patient with confirmed or suspected
COVID-19 outside or in a more ventilated area for treatment where
medically possible (note that the ETS requires healthcare workers to
wear respirators when treating a patient who is confirmed or suspected
to have COVID-19 as well as when they are exposed to aerosol-generating
procedures conducted on a patient who is confirmed or suspected to have
COVID-19).
In some situations, EMS workers might need to ride in the cab
within 6 feet of each other as well as the patient being transported.
In these situations, overlapping controls, such as requiring all EMS
workers in the patient compartment to wear appropriate PPE and to wash
their hands or use an alcohol-based hand sanitizer that contains at
least 60% alcohol, have been implemented. Moreover, as stated, where
feasible, physical barriers can be constructed to isolate the driver's
cab from the rear patient care area. In addition, patients riding in
the rear compartment can wear a face covering and face shield, when
possible, or at least a face shield when a face covering is not
possible. Employers have also established procedures to open outside
air vents in the cab and turn on the rear exhaust ventilation fans to
the highest setting to create a pressure gradient toward the patient
area.
It is also common that EMS operations must quickly return an
ambulance to service after responding to an emergency involving, or
transporting patients who are, COVID-19 positive. In such
circumstances, multiple EMS workers must often concurrently participate
in cleaning and disinfection of the patient area in the ambulance. In
these situations, employers have used outdoor cleaning areas or indoor
exhaust ventilation, in addition to following widely-established
polices requiring PPE and face coverings.
Long-Term Care
Long-term care employers operate nursing homes, retirement
communities, assisted living facilities, and intermediate and
continuing care facilities. There are a wide range of job titles for
workers in this industry including healthcare providers (e.g.,
physicians, nurses, nurses' assistants, orderlies, physical,
occupational, and speech therapists, personal care aides, and
psychiatric aides), as well as support staff (e.g., facility
administration, reception, engineering and maintenance, housekeeping,
laundry, food service, transportation, pharmacy, and security).
OSHA identified a number of physical distancing strategies that
have been implemented in various areas of long-term care facilities
such as reception areas, waiting rooms, dining rooms, and common areas.
These strategies include: Restricting the number of visitors; limiting
access to the residential area to essential workers (i.e., maintenance
workers performing non-critical tasks and staff performing billing
services would not be granted access); increasing the number of meal
services; limiting the number of residents in the dining area at one
time; and providing room service.
Although physical distancing can be feasibly maintained most of the
time, there are some situations where workers in long-term care
facilities cannot always avoid physical proximity with residents,
visitors, or co-workers. Long-term care employers have installed
physical barriers to protect employees in many of these situations. For
example, resident care and front desk staff may need to be within 6
feet of visitors during visitor check-in or when providing information
or assistance, and administrative staff may have a central counter for
information and resources for residents. In these situations, employers
have installed physical barriers between workstations and visitor or
resident areas. Food servers and aides may need to be within 6 feet of
a resident when serving food, servicing or clearing buffet food lines,
and when providing assistance. In these situations as well, employers
have installed physical barriers between employees and residents.
Healthcare providers may also need to provide care or therapy in
resident rooms or other care/therapy areas. As part of a multilayered
approach to infection control, some employers have required workers
caring for residents to wear a gown, safety glasses, gloves, and either
a surgical mask or N95 respirator (depending on whether the worker is
providing care to residents with suspected or confirmed COVID-19, for
example). Also, in accordance with American Health Care Association/
National Center for Assisted Living (AHCA/NCAL) recommendations,
employers have, to the extent possible, reduced the frequency of
routine procedures, such as taking vital signs and weights, and have
also required residents to wear a face covering when staff enter their
rooms or when receiving care/therapy from a healthcare provider, unless
they are medically unable to do so. Many employers have also
implemented cohorting procedures for staff and patients (i.e.,
assigning staff to specific residents and only those residents) while
minimizing staff working across units (AHCA and NCAL, April 21, 2020).
Home Healthcare, Personal Care, and Companion Service Providers
OSHA developed a physical distancing scenario for organizations
that visit private residences to provide healthcare services and health
care support services. Employers in this industry use a wide range of
job titles for their workers including professional home healthcare
practitioners (e.g., physicians, nurses, medical technicians); personal
care providers (e.g. self-care aides); and other workers who offer
companion services for disabled persons, the elderly, and persons
diagnosed with intellectual and developmental disabilities.
To help ensure physical distancing, employers in this industry have
switched to virtual services when possible by determining whether some
clients' needs can be met through telehealth or with online technology,
such as video conferencing. Many physical distancing strategies have
also been implemented by employers of this sector when services must be
conducted at a patient's private residence. These include implementing
protocols for workers to maintain 6 feet of distance from clients and
other household members, and for workers providing service in teams to
maintain 6 feet of distance from each other, as much as possible while
they perform their work. Employers have also implemented procedures to
instruct all people within the household (other than the direct client
receiving services) to go to another room, or at a minimum, maintain at
least 6 feet of distance from workers.
Workers performing in-home healthcare or personal care services
cannot always feasibly maintain 6 feet of physical distance from their
clients or co-workers. In these situations, companies have successfully
implemented a multi-layered suite of controls such as requiring all
workers to wear facemasks, respiratory protection, or other PPE, and
requiring patients and members of households to self-screen for COVID-
19 before the visit. Also employers have required all workers to wash
their hands or use an alcohol-based hand sanitizer that contains at
least 60% alcohol before and after each visit, and have implemented
administrative controls such as assigning workers to ``bubbles'' or
cohorts to reduce the number of other individuals with whom a worker
comes in physical proximity. Finally, employers have taken steps to
ensure that private residences have adequate airflow by way of either
an HVAC system or open windows and doors.
Postmortem Services
OSHA developed a physical distancing scenario to address the
conduct of autopsies. Jobs involved in conducting medical autopsies
generally fall within the following categories; medical examiners,
forensic pathologists, and autopsy technicians who examine bodies
postmortem; and administrative and clerical staff who may be essential
for support purposes.
The postmortem care industry has implemented a variety of physical
distancing controls to prevent physical proximity (within 6 feet) of
other people when performing autopsies. Physical distancing controls
for these situations are meant to keep professional healthcare
practitioners and, in some cases guests (e.g., law enforcement, family
members of the deceased), at least 6 feet apart. These strategies
include posting reminders of the need to maintain at least 6 feet of
physical distance from other persons, where possible, training workers
on proper physical distancing relative to other workers and guests, and
establishing work schedules (e.g., alternating days, extra shifts) that
reduce the total number of workers in a facility at any given time. In
addition, many employers require workers to limit the number of staff
in the prep/exam room at any given time to the minimum number
necessary.
In workplaces where autopsies are performed, physical proximity
cannot always be avoided. In these situations, facilities have
successfully implemented a multi-layered suite of controls, such as
wearing appropriate PPE, to protect workers from other people (e.g.,
guests or other staff) during postmortem medical examination, for
example. Physical barriers have also been installed in other areas
where physical distancing may be difficult to maintain including, at
reception counters, in restrooms, in consultation rooms, and in
offices, for example.
Summary of Feasibility Challenges for Distancing and Physical Barriers
While OSHA strongly emphasizes the use of physical distancing and
physical barriers, it recognizes that there are a few situations where
employers have found that it is not feasible to implement either or
both. Physical distancing and physical barriers may not be feasible
during direct patient care, including the conduct of Emergency Medical
Services (EMS) while treating a patient in the back of an ambulance,
for example. Physical barriers may also be infeasible where they
obstruct an emergency egress path or interfere with a facility's fire
safety systems (e.g., fire alarm notification devices, fire sprinklers,
fire pull stations).
OSHA emphasizes a multilayered approach for employers to protect
their workers: Physical distancing and, if necessary, physical barriers
at fixed work locations outside of direct patient care areas must be
used in conjunction with other controls, such as facemasks, hand
hygiene, and ventilation, and not as the sole means of control. When
confronting the rare situations where both physical distancing and
physical barriers are not feasible, employers can still implement the
remaining layers of overlapping controls, including facemasks, hand
hygiene, and ventilation, required by the standard to reduce the risk
of COVID-19 transmission.
Based on the evidence that physical distancing and physical
barriers are already being implemented across a broad range of
healthcare settings, OSHA concludes that it is feasible to implement
the ETS's requirements for physical distancing and for physical
barriers at fixed work locations outside of direct patient care areas
(e.g., entryway/lobby, check-in desks, triage, hospital pharmacy
windows, bill payment). In the few cases where physical distancing and
physical barriers are both not feasible, work can be conducted to
maintain as much distance as possible, and the additional controls such
as facemasks, ventilation, and hygiene required by the ETS will still
provide some measure of protection.
d. Ventilation
Ventilation systems are another necessary part of a multilayered
strategy to control transmission of COVID-19 (CDC, March 23, 2021). As
will be discussed in more detail below, the
ability of heating, ventilation, and air conditioning (HVAC) systems to
reduce the risk of exposure depends on many factors, including design
features, operation and maintenance practices, and the quality and
quantity of outdoor air supplied to the space. Paragraph (k) of the ETS
require employers who own or control buildings or structures with
existing heating, ventilation, and air conditioning (HVAC) systems to
ensure that: (1) Each HVAC system is used in accordance with the HVAC
manufacturer's instructions and its design-specifications; (2) the
amount of outside air circulated through its HVAC system and the number
of air changes per hour (ACHs) are maximized to the extent appropriate;
(3) all air filters are rated Minimum Efficiency Reporting Value (MERV)
13 or higher, if compatible with the HVAC system (or, alternatively,
rated at the highest compatible filtering efficiency); (4) all air
filters are maintained and replaced as necessary; and (5) all outside
air intake ports are clean, maintained, and cleared of any debris that
may affect the function and performance of the HVAC system. Moreover,
where an employer has an existing airborne infection isolation room
(AIIR), the employer must maintain and operate it in accordance with
its design and construction criteria.
In the remainder of this section, OSHA discusses how employers can
comply with these requirements and then draws its conclusion on
technological feasibility.
Using HVAC Systems in Accordance With Manufacturer's Instructions and
Design Specifications
To meet the ETS's requirements, employers must verify that the
system is functioning as designed. Because each building and its
existing HVAC systems will be different, the employer might need to
consult a professional engineer or HVAC specialist to determine the
best way to maximize the system's ventilation and air filtration
capabilities for each specific room in the building and thereby ensure
the system is operating according to design specifications.
The American Society of Heating, Refrigeration and Air Conditioning
Engineers (ASHRAE) Standard 180-2018 Standard Practice for Inspection
and Maintenance of Commercial Building HVAC Systems provides guidance
on preventive maintenance for HVAC systems, including checklists that
employers can use to verify the system is operating as designed
(ASHRAE, June 11, 2018). Additional guidance can be found in CDC's
Guidance for Businesses and Employers Responding to Coronavirus Disease
2019 (COVID-19) (CDC, March 8, 2021), and the ASHRAE Guidance for Re-
Opening Buildings (ASHRAE, October 5, 2020).
Healthcare settings have additional HVAC design parameters for
meeting specifications for directional airflow and relative pressure
differentials. For example, according to ASHRAE's Standard 170
Ventilation of Health Care Facilities, ventilation systems that provide
air movement from clean areas (e.g., nursing stations) to potentially
contaminated areas (e.g., patient airborne infection isolation rooms)
are recommended for preventing airborne transmission. Thus, the air
pressure of the room or space would be maintained at a negative
pressure relative to the hallways and surrounding spaces. This means
that when the door is opened, potentially contaminated air or other
dangerous particles from inside the room will not flow outside into
non-contaminated areas. (ASHRAE, 2017). Normally functioning existing
isolation rooms should already be able to serve this function because
Joint Commission accreditation and Centers for Medicare & Medicaid
Services (CMS) regulations have requirements for negative pressure
airborne infection isolation rooms design.
Using AIIRS in Accordance With Design and Construction Criteria
AIIRs are designed to prevent the transmission of airborne
transmissible agents to areas outside a patient's room. These rooms
have a high air exchange rate and are under negative air pressure,
meaning that the room air has a slight negative pressure compared to
the surrounding rooms. The high air exchange rate (at least 12 air
changes per hour (ACH) for new construction or renovation, 6 ACH
otherwise) helps change the room air frequently and reduces (but does
not eliminate) buildup of airborne disease agents, such as the virus
that causes COVID-19. The negative air pressure differential (0.01 inch
of water [2.5 Pa]) helps reduce the chance that the remaining airborne
virus will exit the room door and contaminate air in adjacent hallways.
An anteroom is a beneficial room feature that helps further isolate the
AIIR from the adjacent hallway. When the AIIR has an anteroom, the
AIIR's air pressure should be negative to the anteroom, while the
anteroom air pressure should be negative to the adjacent hallway. This
arrangement means air from the hallway will flow into the anteroom each
time the door is opened, and air from the anteroom will flow into the
AIIR--minimizing the amount of airborne disease agents (virus) that
exits the room. ASHRAE Standard 170, Ventilation of Health Care
Facilities offers detailed guidance for designing and operating AIIRs
(ASHRAE, 2017).
Maximizing Outside Air Circulated Through HVAC System(s) and the Number
of Air Changes per Hour (ACHs) to the Extent Appropriate
Building HVAC systems are designed to draw in a certain amount of
outdoor air into the building to maintain indoor air quality. By
introducing fresh air into the building, HVAC systems can prevent the
buildup of airborne contaminants through dilution.
The introduction of outdoor air into the building can also help
limit the potential for the virus that causes COVID-19 to accumulate in
the building. The more outdoor air the HVAC system is capable of
drawing into the building, the greater the impact may be on limiting
the potential for the virus to accumulate. Maximizing the amount of
outdoor air introduced to the system can be achieved by fully opening
the building's outdoor air intake dampers; however, this may introduce
other indoor air quality or comfort concerns resulting from humidity,
temperature extremes, or outdoor pollution. Employers should work with
building managers or HVAC professionals to adjust the HVAC system to
bring in as much outdoor air as possible, while taking into
consideration outdoor pollution levels and ensuring that the HVAC
system is capable of maintaining building temperature and humidity
levels within acceptable occupant comfort ranges. OSHA notes that it
does not expect employers to reconfigure duct work to comply with this
provision. When maximizing the outside air, employers should take into
account not to draw in air from potential pollution sources such as
smoking areas, loading docks, vehicle traffic areas, or active
construction zones, or air being re-entrained from the building exhaust
itself.
Balancing refers to the process of measuring the air flow through
the supply ducts and adjusting the dampers to provide an even
distribution of air through the HVAC system duct work and supply vents.
According to ASHRAE Standard 111 Measurement, Testing, Adjusting, and
Balancing of Building HVAC Systems, testing and balancing an HVAC
system provides the means to determine and monitor system performance.
Proper balancing ensures that outdoor air brought into the building
will be evenly supplied to all areas of the building and limit the
potential for ventilation dead zones or stagnant air to accumulate
(ASHRAE, October 31, 2017).
In addition to considering the factors discussed above with respect
to maximizing outside air, employers must also consider how to maximize
ACHs. ACHs are a measure of the air volume that is added to or removed
from a space in one hour divided by the volume of the space. The more
frequently the air within that space is replaced per hour, or the more
ACHs, the more the overall potential concentration of COVID-19 in the
work environment will be reduced. Building owner/operators or employers
can seek assistance from HVAC professionals on maximizing ACHs based on
the workspace and the design capabilities of the HVAC system(s)
(ASHRAE, 2017).
Using Air Filters Rated MERV 13 or Higher, if Compatible With the HVAC
System(s), or, Alternatively, to the Highest Compatible Filtering
Efficiency
Building HVAC systems are equipped with air filters that remove
particles from recirculated air streams before returning the air to
occupied spaces. Air filters are available in a variety of materials
such as pleated paper, cloth, woven fiberglass, and polyester. A
filter's efficiency is measured by the fraction of particles the filter
is able to remove from the air stream. The higher the filter's
efficiency the better it is at removing particles from the air. There
are several systems for rating filter efficiencies. The most common is
the MERV rating system, which was developed by ASHRAE.
Many existing HVAC systems are designed and installed to operate
with filters ranging from MERV 6 to MERV 8. MERV 8 filters are only
about 20 percent efficient in removing particles in the 1 [micro]m to 3
[micro]m size range (the size range of concern for aerosol droplets
containing the virus that causes COVID-19). Employers and building
managers can improve this efficiency by upgrading to MERV 13 or higher
filters, to the extent those filters are currently compatible with
system components (e.g., filter housing slot type, size, and shape).
MERV 13 filters are at least 85 percent efficient at capturing
particles in the 1 [micro]m to 3 [micro]m size range. Increasing filter
efficiency, however, can increase pressure drop across the filters
leading to increased fan energy use, reduced airflow rates, and or/
issues controlling indoor temperature and humidity levels. As a result,
employers and building owners may need to consult an HVAC professional
to optimize filter efficiency consistent with their HVAC system's
capabilities.
Maintaining and Replacing All Air Filters as Necessary
The required frequency for changing filters will vary depending on
the characteristics of the HVAC system, and therefore the ETS does not
specify a frequency for filter changing.
Ensuring All Outside Air Intake Ports Are Clean, Maintained, and
Cleared of Any Debris That May Affect the Function and Performance of
the HVAC System(s)
To comply with this provision, a visual inspection of the outside
air intakes, which can be accomplished as part of a routine maintenance
program, is required.
Additional Ventilation Measures
A note to the ETS's ventilation requirements provides that, in
addition to the requirements for existing HVAC systems and AIIRs, all
employers should also consider other measures to improve ventilation in
accordance with CDC guidance. Below are some additional measures that
an employer should consider to increase total airflow supply to
occupied spaces:
Disabling demand-control ventilation (DCV) controls that
reduce air-supply based on temperature or occupancy;
Using natural ventilation (i.e., opening windows if
possible and safe to do so) to increase outdoor air dilution of indoor
air when environmental conditions and building requirements allow;
Running the HVAC system at maximum outside airflow for 2
hours before and after occupied times;
Generating clean-to-less-clean air movements, re-
evaluating the positioning of supply and exhaust air diffusers and/or
dampers, and adjusting zone supply and exhaust flow rates to establish
measurable pressure differentials;
Requiring that staff work in ``clean'' ventilation zones
and not in higher-risk areas (e.g., visitor reception) to the extent
feasible;
Using portable high-efficiency particulate air (HEPA) fan/
filtration systems to help enhance air cleaning especially in higher-
risk areas; and
Ensuring exhaust fans in restroom facilities are
functional and operating at full capacity when the building is
occupied.
The terms of the ETS make clear that there are no technological
hurdles to compliance with its ventilation requirements. First, the
ventilation requirements apply only to existing systems. A note in the
ETS emphasizes that the requirements do not require installation of new
HVAC systems or AIIRS, or upgrades of existing systems to replace or
augment functioning systems. Therefore, the ventilation requirements do
not raise the questions of feasibility typically associated with
employers needing to install new engineering controls to come into
compliance with a new standard.
Second, the HVAC requirements apply only to employers who own or
control buildings or structures. Thus, for example, the requirements do
not apply to employers who lease space and do not control the building
or structure, and the ETS does not raise questions as to how these
employers would comply with the ventilation requirements.
Third, employers covered by the general section are required only
to ensure that HVAC systems operate with a sufficient filter (MERV-13
where possible) in accordance with manufacturer's instructions and
design specifications, and only in a manner that is appropriate for the
system using methods that are compatible with the system, and that
AIIRs are maintained and operated in accordance with their design and
construction criteria. As such employers are not required by the ETS to
modify their HVAC systems or AIIRs in any manner, only to ensure that
they are operating as designed, which negates questions as to how the
employer would make modifications.
Fourth, a number of the plans, best practice documents, and
scenarios discussed above reference HVAC systems and ventilation. The
use of HVAC systems to manage building air filtration and circulation
of fresh air as part of overlapping controls to address the COVID-19
hazard illustrate that there is no technological feasibility barrier to
compliance with the ETS's ventilation requirements in typical firms in
all affected industries. The ETS's filter requirements are inherently
technologically feasible because they only require the installation of
the
maximum filter that is compatible with the applicable HVAC system.
The design and complexity of HVAC systems can vary widely depending
on a range of factors including the use, size, and age of the building,
and, as discussed, deciding on the maximum appropriate amount of
outside air to circulate through the HVAC system(s) and number of ACHs
can be a complex task. However, larger buildings have dedicated
facilities management staff who are responsible for regular ventilation
system maintenance and adjustment and will have the prerequisite
experience to evaluate the capabilities of the HVAC system, while in
other cases, employers may need to consult with an HVAC professional to
ensure that facilities HVAC is functioning in accordance with the HVAC
manufacturer's instructions and the design specifications of the HVAC
system(s). Based on these factors, OSHA concludes that there are no
technological barriers to compliance with the ETS's ventilation
requirements.
e. Other Provisions
There are no technological feasibility barriers related to
compliance with other requirements in the ETS (e.g., facemasks, and
respirators, cleaning and disinfection, health screening and medical
management, employee notification). Indeed, as explained above, many of
the plans, best practice documents, and scenarios reviewed by OSHA
indicate that these controls have been implemented by employers across
industry sectors as part of a multilayered approach to protecting
workers from the COVID-19 hazard. OSHA highlights a few of the ETS's
other requirements below, but only to point out administrative issues
that will be explored in more depth in other sections of the preamble.
Facemasks. The ETS requires employers to provide, and
ensure that employees wear, facemasks that are FDA-cleared, authorized
by an FDA EUA, or offered or distributed as described in an FDA
enforcement policy. Facemasks that meet these requirements are
currently widely available.
There may be situations where wearing a facemask presents
a hazard to an employee of serious injury or death (e.g., arc flash,
heat stress, interfering with the safe operation of equipment). The
relevant section of the Summary and Explanation provides further
discussion on this topic.
Respirators. As noted in Need for Specific Provisions and
Summary and Explanation (Sections V and VIII of the preamble,
respectively), the increased need for respirators by healthcare workers
during the pandemic has resulted in shortages of N95 filtering
facepiece respirators (FFRs). The ETS addresses these shortages by
encouraging employers to use not only N95 FFRs, but also other
respirators such as elastomeric respirators and powered air-purifying
respirators (PAPRs), where feasible. For further details, see paragraph
(f) of the ETS, as well as relevant sections of Need for Specific
Provisions and Summary and Explanation.
Notification. Paragraphs (l)(2) and (l)(3) of the ETS
contain COVID-19-connected notification requirements for both the
employer and the employee. OSHA identifies no technological feasibility
issues in connection with the ETS's notification requirements. It is
the employer's responsibility to ensure that appropriate instructions
and procedures are in place so that designated representatives of the
employer (e.g., managers, supervisors) and employees conform to the
rule's requirements.
There are also no technological barriers to compliance with the
mini respiratory protection program section of the ETS. That section
requires employers, many of whom have never developed or implemented a
respiratory protection program under the Respiratory Protection
standard, 29 CFR 1910.134, to develop and implement one if their
employees wear respirators. However, the mini respiratory protection
program section will require a program that is far less extensive, and
thus easier to comply with, than what is required under 29 CFR
1910.134. For example, the mini respiratory protection program section
will not require quantitative fit testing or medical evaluations
regarding employees' ability to use respirators, both of which are
required under 29 CFR 1910.134. Therefore, OSHA concludes that
compliance with the mini respiratory protection program section does
not raise issues of technological feasibility. OSHA discusses the
administrative cost of complying with the mini respiratory protection
program section in its economic feasibility analysis.
II. Conclusions
OSHA has reviewed the requirements imposed by the ETS and has
determined that achieving compliance with the rule is technologically
feasible for typical operations in the settings that are covered by the
ETS. In reaching this determination, OSHA reviewed evidence that shows
that healthcare-specific good infection control practices are routinely
implemented by employers who have employees in covered settings. This
evidence includes: Readily available CDC infection control guidance
documents, many of which are COVID-19 specific; regulations issued by
the Centers for Medicare & Medicaid Services (CMS), compliance with
which is typically required for accreditation of these settings by The
Joint Commission; and the application of similar requirements in OSHA's
Bloodborne Pathogens Standard, 29 CFR 1910.1030.
OSHA's assessment also analyzed the technological feasibility of
complying with the requirements of the ETS for developing a COVID-19
Plan: Maintaining physical distancing; installing physical barriers;
and ensuring existing ventilation systems are operating as designed. As
noted, the ETS requires employers to develop and implement a COVID-19
plan through a multilayered approach to addressing the spread of COVID-
19 by taking feasible measures to reduce or eliminate the transmission
of COVID-19. This includes requirements for employers to implement
procedures to ensure employees maintain at least 6 feet of physical
distancing from others to the extent feasible and, when distancing is
not feasible, to install physical barriers, again to the extent
feasible. It also allows flexibility in the material of barriers.
OSHA recognizes that sometimes it may not be feasible to implement
either physical distancing or physical barriers for particular work
activities, but even if this is the case, employers must still protect
their employees through the other provisions of the flexible
multilayered approach required by the ETS. The regulatory text allows
for alternatives in some situations, and OSHA has identified a variety
of alternatives that it believes would be technologically feasible in
those situations most of the time. As explained, there are no
technological feasibility barriers related to compliance with
requirements in the ETS for facemasks and respirators, cleaning and
disinfection, health screening and medical management, or employee
notification. Based on the combination of OSHA's evaluation of
technological feasibility of controls in the various scenarios
examined, OSHA finds that the ETS is technologically feasible.
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Garner, J. (1996). Guideline for isolation precautions in hospitals.
The Hospital Infection Control Practices Advisory Committee.
Infection Control and Hospital Epidemiology 17(1): 53-80. https://doi.org/10.1086/647190. (Garner, 1996).
HCA Healthcare. (2021). Our COVID-19 response. https://hcahealthcare.com/covid-19/index.dot. (HCA Healthcare, 2021).
The Joint Commission. (2021a). About our Standards. https://www.jointcommission.org/standards/about-our-standards/. (The Joint
Commission, 2021a).
The Joint Commission. (2021b). Facts about the Joint Commission.
https://www.jointcommission.org/about-us/facts-about-the-joint-commission/. (The Joint Commission, 2021b).
The Joint Commission. (2021c). Accreditation and Certification.
https://www.jointcommission.org/accreditation-and-certification/.
(The Joint Commission, 2021c).
Johns Hopkins Medicine. (2021). Coronavirus (COVID-19) Information
and Updates: COVID-19 Testing and Care. https://www.hopkinsmedicine.org/coronavirus/testing-and-care.html. (Johns
Hopkins Medicine, 2021).
MedStar Health. (2021, May 5). Information from MedStar Health on
COVID-19. https://www.medstarhealth.org/mhs/about-medstar/covid-19-info/. (MedStar, May 5, 2021).
Michigan Medicine, University of Michigan (Michigan Medicine U-M).
(2021, May 18). U-M COVID-19 Preparedness and Response Plan. https://ehs.umich.edu/wp-content/uploads/2020/05/UM-COVID-19-Preparedness-and-Response-Plan.pdf. (Michigan Medicine U-M, May 18, 2021).
Miller, J et al., (2012, January 6).Guidelines for Safe Work
Practices in Human and Animal Medical Diagnostic Laboratories. MMWR
2012; 61(01); 1-101. https://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm. (Miller et al., January 6, 2012).
National Association for Home Care & Hospice (NAHC). (2020, March
3). Guide for Household Members, Intimate Partners, and Caregivers.
https://www.nahc.org/wp-content/uploads/2020/03/Coronavirus-Caregiver-Guide-Customizable.docx. (NAHC, March 3, 2020).
New Mexico EMT Association (NMEMTA). (2020, March 29). Coronavirus
Guidelines. http://www.nmemta.org/CoronavirusGuideline03-29-2020.pdf. (NMEMTA, March 29, 2020).
Rusnak, J et al., (2004, September). Laboratory exposures to
staphylococcal enterotoxin B. Emerging Infectious Diseases, 10(9):
1544-1549. https://doi.org/10.3201/eid1009.040250. (Rusnak et al.,
September 2004).
Santa Clara Valley Medical Center (SCVMC). (2020, December 1).
COVID-19 Exposure, Risk Assessment, Contact Tracing, Testing, and
Return to Work Guidelines for Healthcare Workers (HCWs). https://www.scvmc.org/COVID19/Employee/12012020%20COVID%20Exposure%20Policy.pdf. (SCVMC, December 1, 2020).
Siegel, J, Rhinehart, E, Jackson, M, Chiarello, L, and the
Healthcare Infection Control Practices Advisory Committee. (2007).
2007 Guideline for isolation precautions: preventing transmission of
infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).
World Health Organization (WHO). (2016). Guidelines on Core
Components of Infection Prevention and Control Programmes at the
National and Acute Health Care Facility Level. (WHO, 2016).
B. Economic Feasibility
I. Introduction
This section presents OSHA's estimates of the costs, benefits, and
other impacts anticipated to result from the ETS. The estimated costs
are based on employers achieving full compliance with the requirements
of the ETS. They do not include prior costs associated with firms whose
current practices are already in compliance with the ETS requirements.
The purpose of this analysis is to:
Identify the establishments and industries affected by the
ETS;
Estimate and evaluate the costs and economic impacts that
regulated establishments will incur to achieve compliance with the ETS;
Evaluate the economic feasibility of the rule for affected
industries; and
Estimate the benefits resulting from employers coming into
compliance with the rule in terms of the reduction in COVID-19 disease
and resulting fatalities.
In this analysis, OSHA is fulfilling the requirement under the OSH
Act to show the economic feasibility of this ETS. This analysis is
different from a benefit-cost analysis prepared in accordance with E.O.
12866 in that the agency is focused only on costs to employers when
evaluating economic feasibility. In a true benefit-cost analysis, the
costs to all parties (e.g., employees,
governments) are included. Throughout this analysis, there are places
where OSHA estimates there are no costs borne by employers. This does
not necessarily mean that there are no costs or burdens imposed on
others but, from the standpoint of establishing feasibility, these are
not being assessed as part of OSHA's analysis of economic
feasibility.\30\
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\30\ For example, there are places in the analysis where OSHA
specifically accounts for costs being shifted away from employers
through tax credits and other programs aimed at responding to the
pandemic. While the direct costs to employers are reduced for
purposes of evaluating feasibility, those costs would be
attributable to the ETS in a true benefit-cost analysis.
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A standard must be economically feasible in order to be
``necessary'' under section 6(c)(1)(B) of the OSH Act. Cf. Am. Textile
Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490, 513 n. 31 (1981) (Cotton
Dust) (``any standard that was not economically . . . feasible would a
fortiori not be `reasonably necessary or appropriate' under the Act'');
Nat'l Maritime Safety Ass'n v. Occupational Safety & Health Admin., 649
F.3d 743, 752 (D.C. Cir. 2011). A standard is economically feasible
when industries can absorb or pass on the costs of compliance without
threatening industry's long-term profitability or competitive
structure, Cotton Dust, 452 U.S. at 530 n. 55, or ``threaten[ing]
massive dislocation to, or imperil[ing] the existence of, the
industry.'' United Steelworkers of Am. v. Marshall, 647 F.2d 1189, 1272
(D.C. Cir. 1981) (Lead I). Given that section 6(c) is aimed at enabling
OSHA to protect workers in emergency situations, the agency is not
required to make the showing with the same rigor as in ordinary section
6(b) rulemaking. Asbestos Info. Ass'n/N. Am. v. OSHA, 727 F.2d 415, 424
n.18 (5th Cir. 1984). In Asbestos Information Association, the Fifth
Circuit concluded that the costs of compliance were not unreasonable to
address a grave danger where the costs of the ETS did not exceed 7.2%
of revenues in any affected industry. Id. at 424.
OSHA's evaluation of the overall costs and benefits of the ETS has
been performed for the purposes of complying with requirements outside
of the OSH Act (e.g., Executive Orders 12866 and 13563, the Unfunded
Mandates Reform Act). ``[T]he Supreme Court has conclusively ruled that
economic feasibility [under the OSH Act] does not involve a cost-
benefit analysis.'' Pub. Citizen Health Research Grp. v. U.S. Dept. of
Labor, 557 F.3d 165, 177 (3d Cir. 2009); see also Asbestos Info. Ass'n,
727 F.2d at 424 n.18 (noting that formal cost benefit is not required
for an ETS, and indeed may be impossible in an emergency). The OSH Act
``place[s] the `benefit' of worker health above all other
considerations save those making attainment of this `benefit'
unachievable.'' Cotton Dust, 452 U.S. at 509. Therefore, ``[a]ny
standard based on a balancing of costs and benefits by the Secretary
that strikes a different balance than that struck by Congress would be
inconsistent with the command set forth in'' the statute. Id. While
this case law arose with respect to health standards issued under
section 6(b)(5) of the Act, which specifically require feasibility,
OSHA finds the same concerns applicable to emergency temporary
standards issued under section 6(c) of the Act. An ETS ``serve[s] as a
proposed rule'' for a section 6(b)(5) standard, and therefore the same
limits on any requirement for cost-benefit analysis should apply.
Indeed, OSHA has also rejected the use of formal cost benefit analysis
for safety standards, which are not governed by section 6(b)(5). See 58
FR 16612, 16622-23 (Mar. 30, 1993) (``in OSHA's judgment, its statutory
mandate to achieve safe and healthful workplaces for the nation's
employees limits the role monetization of benefits and analysis of
extra-workplace effects can play in setting safety standards.'').\31\
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\31\ To support its Asbestos ETS, OSHA conducted an economic
feasibility analysis on these terms. 48 FR 51086, 51136-38 (Nov. 4,
1983). In upholding that analysis, the Fifth Circuit said that OSHA
was required to show that the balance of costs to benefits was not
unreasonable. Asbestos Info. Ass'n, 727 F.2d at 423. As explained
above, OSHA does not believe that is a correct statement of the
economic feasibility test. However, even under that approach this
ETS easily passes muster.
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The scope of judicial review of OSHA's determinations regarding
feasibility (both technological and economic) ``is narrowly
circumscribed.'' N. Am.'s Bldg. Trades Unions v. OSHA, 878 F.3d 271,
296 (D.C. Cir. 2017) (Silica). ``OSHA is not required to prove economic
feasibility with certainty, but is required to use the best available
evidence and to support its conclusions with substantial evidence.''
Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 980-81 (D.C. Cir. 1991)
(Lead II); 29 U.S.C. 655(b)(5), (f). ``Courts, [moreover], `cannot
expect hard and precise estimates of costs.' '' Silica, 878 F.3d at 296
(quoting Lead II, 939 F.2d at 1006). Rather, OSHA's estimates must
represent ``a reasonable assessment of the likely range of costs of its
standard, and the likely effects of those costs on the industry.'' Lead
I, 647 F.2d at 1266. The ``mere `possibility of drawing two
inconsistent conclusions from the evidence,' or deriving two divergent
cost models from the data `does not prevent [the] agency's finding from
being supported by substantial evidence.' '' Silica, 878 F.3d at 296
(quoting Cotton Dust, 452 U.S. at 523).
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of the intended regulation and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, and public health and
safety effects; distributive impacts; and equity). Executive Order
13563 emphasized the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
OSHA has prepared this ETS and the accompanying economic analysis on an
extremely condensed timeline and has complied with E.O. 12866 and E.O.
13563 only to the extent practicable under the circumstances (see Exec.
Order No. 13999, Jan. 21, 2021, 86 FR 7211 (Jan. 26, 2021)). This rule
is an economically significant regulatory action under Sec. 3(f) of
Executive Order 12866 and has been reviewed by the Office of
Information and Regulatory Affairs in the Office of Management and
Budget, as required by executive order.
II. Healthcare Industry Profile
a. Introduction
In this section, OSHA provides estimates of the number of affected
entities, establishments, and employees for the industries that have
settings covered by 29 CFR 1910.502. The term ``entity'' describes a
legal for-profit business, a non-profit organization, or a local
governmental unit, whereas the term ``establishment'' describes a
particular physical site of economic activity. Some entities own and
operate more than one establishment.
Throughout this analysis, where estimates were derived from
available data those sources have been noted in the text. Estimates
without sources noted in the text are based on agency expertise.
b. Scope of the ETS
The ETS applies to all settings where any employee provides
healthcare or healthcare support services except:
The provision of first aid by an employee who is not a
licensed healthcare provider;
the dispensing of prescriptions by pharmacists in retail
settings;
non-hospital ambulatory care settings where all non-
employees are screened prior to entry and people with suspected or
confirmed COVID-19 are not permitted to enter those settings;
well-defined hospital ambulatory care settings where all
employees are fully vaccinated and all non-employees are screened prior
to entry and people with suspected or confirmed COVID-19 are not
permitted to enter those settings;
home healthcare settings where all employees are fully
vaccinated and all non-employees are screened prior to entry and people
with suspected or confirmed COVID-19 are not present;
healthcare support services not performed in a healthcare
setting (e.g., off-site laundry, off-site medical billing); or
telehealth services performed outside of a setting where
direct patient care occurs.
In well-defined areas of covered settings where there is no
reasonable expectation that any person with suspected or confirmed
COVID-19 will be present, paragraphs (f), (h), and (i) do not apply to
employees who are fully vaccinated.
Healthcare services are delivered through various means including,
but not limited to: Hospitalization, long-term care, ambulatory care
(e.g., treatment in physicians' offices, dentists' offices, and medical
clinics), home health and hospice care, and emergency medical response.
Healthcare support services include, but are not limited to, patient
intake/admission, patient food services, equipment and facility
maintenance, housekeeping, healthcare laundry services, medical waste
handling services, and medical equipment cleaning/reprocessing
services.
In order to determine which employers are covered by the ETS, OSHA
identified both the occupations where workers would be providing
healthcare and healthcare support services and the setting where those
tasks would be done. For example, a social worker in a hospital may be
working in conjunction with healthcare providers and therefore
providing healthcare or healthcare support services. However, a social
worker working for a children and family services or social advocacy
organization would not be covered by the ETS since neither they nor
anyone else at their organization would be providing healthcare or
healthcare support services.
OSHA's methodology for determining which establishments and
employees are covered by the ETS focuses on job tasks and settings.
OSHA did not assign costs to certain categories of job tasks because
they are excluded from the scope of the ETS by paragraph (a). These
include: Employees who are teleworking; employees who are providing
services via telehealth; employees providing healthcare support
services at off-site locations; employees who are in uncovered portions
of settings (e.g., retail stores with health clinics, schools with
school nurses) that are not fully covered by the ETS; and employees who
work in parts of hospitals that would meet the ambulatory care
exemption in paragraph (a)(2)(iv). Numerous employees of hospitals,
long-term care facilities, and nursing homes are likely to fall into
one of these categories. While these workers are included in Table
VI.B.3 as employees of covered establishments, OSHA has not assigned
employee-based costs to their employers in this analysis.
Furthermore, OSHA has not determined how many non-hospital
ambulatory care providers will screen patients for COVID-19 infections
and symptoms, and therefore be fully exempt from this rule under
paragraph (a)(2)(iii). To the extent that providers meet these
exemption criteria, they will incur no costs for compliance with
respect to these settings. Therefore, for this subset of
establishments, the costs presented in OSHA's analysis will be dramatic
overestimates (i.e., OSHA assumes full costs where costs should be
zero). Overall, however, OSHA believes that the number of workers
estimated to be covered by the ETS is reasonable and leads to
reasonable aggregate estimates of the average costs of compliance for
employers in covered settings.
Table VI.B.1 summarizes the individual North American Industry
Classification System (NAICS) codes, along with OSHA's estimated
percentage of entities and employees, covered by the ETS. The
percentage of entities covered were generally estimated as the
percentage of firms reporting having employees whose occupation would
have them providing healthcare and healthcare support services (see
Appendix VI.B.A). In some healthcare industries (e.g., many of those in
NAICS 62 Health Care and Social Assistance), 100 percent of entities
are estimated to be affected, but for industries outside of the
healthcare sector, no more than 25 percent of entities were estimated
to be covered by the ETS. The percent of employees covered by the ETS
in covered, non-healthcare entities is estimated based on the
percentage of employees in those industries who are reported to be
employed in the occupation categories identified in Appendix VI.B.A.
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Only some state- and local-government entities are included in this
analysis. State- and local-government entities are specifically
excluded from coverage under the OSH Act (29 U.S.C. 652(5)). Workers
employed by these entities only have OSH Act protections if they work
in states that have an OSHA-approved State Plan. (29 U.S.C. 667).
Consequently, this analysis excludes public entities in states that do
not have OSHA-approved State Plans.
Table VI.B.2 presents the states that have OSHA-approved State Plans
and their public entities are included in the analysis.
[GRAPHIC] [TIFF OMITTED] TR21JN21.010
c. Affected Entities and Employees
OSHA used data from the U.S. Census' 2017 County Business Patterns
(CBP) to identify private sector entities and employees, including for-
profit and non-profit entities affected by the ETS (U.S. Census Bureau,
November 21, 2019, U.S. Census Bureau, March, 2020); and uses the
Bureau of Labor Statistics' (BLS) 2017 Quarterly Census of Employment
and Wages (QCEW) to characterize state and local government entities
(BLS, May 23, 2018). For covered public fire departments and
firefighters cross-trained as EMTs, OSHA relied on data from the U.S.
Fire Administration (USFA) National Fire Department Registry (USFA,
2018).
OSHA similarly obtained estimates of the number of employees in
entities from CBP and QCEW. OSHA used the BLS 2018 Occupational
Employment Statistics (OES), which provides NAICS-specific estimates of
employment by occupation, to determine the subset of employees
performing the tasks outlined in the scope of the ETS (BLS, March 29,
2019). Within the affected NAICS industries, OES includes approximately
700 unique occupations. Of these, OSHA identified 90 occupations
representing jobs where workers would perform healthcare or healthcare
support services (see Appendix VI.B.A). OSHA then calculated the
proportion of total employees that these occupations represented for
the NAICS industries that reported employing these occupations in OES
data, and applied those proportions to the CBP and QCEW employee
estimates for the covered entities. This results in an estimate of the
subset of employees by NAICS industry where workers are covered by the
ETS.
For many regulatory economic analyses, the agency uses the most up-
to-date economic data as its baseline to describe the current state of
the economy. It then applies the anticipated changes due to the new
OSHA standard or regulation to that baseline. However, even the most
current data OSHA uses in a typical economic analysis--including
employment, number of establishments, revenue, etc.--represent economic
conditions from at least one calendar year in the past. Even with that
lag in the data due to reporting and compilation time, the idea is that
the basic structure of the economy changes slowly, so the recent past
is a good predictor of the near future.
Given the unique circumstances of the pandemic and its economic
disruption, OSHA's usual approach is inappropriate for the present
analysis. The agency has therefore also made adjustments to the
baseline industry profile to account for the economic conditions that
are expected to persist during the time period in which this ETS will
be in effect. Specifically, OSHA takes the above data as the baseline
for 2019, the last full year before the onset of the pandemic.\32\ Then
the agency adjusted employment and revenue by industry in order to
capture the current adverse conditions and provide better estimates of
employment and revenue both currently and over the period in which the
ETS will be in effect. The detailed methodology for these adjustments
is presented in Appendix VI.B.D.
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\32\ This includes updating revenue numbers for inflation to
2019 using the GDP deflator.
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Table VI.B.3 summarizes the entities and employees covered by the
ETS. OSHA estimates a total of approximately 563,000 entities,
including approximately 749,000 establishments, and approximately 18.1
million total employees who are employed by establishments covered by
the ETS. All affected establishments are assumed to incur the
establishment-based costs of compliance. In addition, OSHA estimates
that there are approximately 10.3 million employees in those
establishments who would not meet any of the exemptions in paragraph
(a) and whose employers would therefore incur per-employee costs of
compliance as well. However, as shown in Table VI.B.3, the portion of
employees for whom OSHA took per-employee costs varies considerably by
NAICS industry.
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d. Affected Small Entities and Employees
While OSHA has determined that it is impracticable to comply fully
with the requirements of the Regulatory Flexibility Act (RFA) (see
Additional Requirements, Section VII of the preamble), the agency has
nevertheless examined the impact of the ETS on small and very small
entities as part of OSHA's analysis of feasibility. There are three
types of small entities under the
RFA: (1) Small businesses; (2) small non-profit organizations; and (3)
small governmental jurisdictions. The Small Business Administration
(SBA) uses characteristics of businesses classified using the NAICS as
a basis for determining whether businesses are small within a given
industry. SBA small entity size criteria vary by industry, but are
usually based on either number of employees or revenue (Table of Small
Business Size Standards (SBA, August 19, 2019)). A small non-profit
organization is any not-for-profit enterprise that is independently
owned and operated and not dominant in its field. A small governmental
jurisdiction is a government of a city, county, town, township,
village, school district, or special district with a population of less
than 50,000.
To determine the number of private SBA-defined small entities, OSHA
relies on 2017 CBP data, which report total revenues by entity and
employment size. For those industries with a revenue criterion, OSHA
calculated the average revenue for each employment size class in the
Census data and identified the largest size class where average revenue
is less than the SBA-defined small entity threshold. For those
industries with employment criterion, OSHA calculated the average
employees per entity by employment size class and included all entities
below the SBA threshold.
To estimate the subset of local government entities that are small,
OSHA uses additional QCEW data that are specified geographically by
county at the 4-digit NAICS level along with 2017 county-level
population data from the U.S. Census Bureau's (December 6, 2018)
American Community Survey. Using these data, OSHA estimates the
percentage of local government entities, by county, that are small
local governments (i.e., in counties with a population less than
50,000), for each affected setting. OSHA then applies these proportions
to the prior national estimates of all local government entities, by
NAICS industry. The RFA's definition of small nonprofits is those not
``dominant in their field.'' As OSHA customarily does, it assumes all
nonprofits are small based on this definition.\33\
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\33\ While the RFA definition suggests that some nonprofits
might not be small entities, there is no set definition for the term
``dominant'' or delineation of what should be considered a
nonprofit's ``field.'' A nonprofit that is the main entity of its
type in a given city is still unlikely to be the dominant nonprofit
of its type in its state or region and even less likely to be
dominant if the ``field'' encompasses the whole U.S. Given these
ambiguities, OSHA has opted to include all non-profits as small
entities.
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Lastly, Table VI.B.5 presents estimates for very small entities
(those with fewer than 20 employees) affected by the ETS. OSHA
estimates that the ETS affects approximately 472,000 very small
entities, employing approximately 2.2
million workers. Of those, approximately 1.2 million are estimated to
be workers who are in scope and covered by the ETS.
[GRAPHIC] [TIFF OMITTED] TR21JN21.013
BILLING CODE 4510-26-C
e. Summary of Affected Firms, Establishments, and Employees by NAICS
Industry and Setting
Table VI.B.6 presents a summary of the number of affected entities,
establishments, and employees by NAICS industry and setting. The cost
estimates presented in this analysis rely on assumptions that are
specific to the type of services provided in various healthcare
settings in each affected NAICS industry. Table VI.B.6 provides the
mapping between the affected NAICS industries and their typical setting
based on the type of services provided.
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[GRAPHIC] [TIFF OMITTED] TR21JN21.015
BILLING CODE 4510-26-C
III. Cost Analysis for the COVID-19 ETS
In this section, OSHA provides estimates of the per-establishment
costs for the requirements of the ETS. Section 6(c)(3) of the OSH Act
states that the Secretary will publish a final standard ``no later than
six months after publication of the emergency standard.'' Costs are
therefore estimated over a six-month time period. However, during that
period, to the extent OSHA finds that a grave danger from the virus no
longer exists for the covered workforce (or some portion thereof), or
new information indicates a change in measures necessary to address the
grave danger, OSHA will update the ETS, as appropriate.
In developing the cost estimates, OSHA estimates that some
establishments are already following at least some of the ETS's
requirements. The extent to which firms are already meeting the
requirements of this ETS is estimated based, in part, on data presented
in ERG (August 9, 2013), the infectious disease expert panel report
prepared for OSHA. Because the expert panel was conducted pre-pandemic,
OSHA determined that some compliance rates were likely too low given
the heightened awareness of infection control practices, the amount of
time since the pandemic started, and, especially, the outbreaks in
healthcare settings and recognition of the importance of infection
control measures for protecting workers and patients. In those limited
circumstances, OSHA constrained compliance to be no less than 75
percent for large and SBA-defined small entities and 50 percent for
very small entities. Where establishments are already meeting ETS
requirements, those costs are not attributable to the ETS. Throughout
this analysis, where OSHA provides no other estimate, the agency
assumes baseline compliance rates of 50 percent for very small entities
and 75 percent for all other entities.34 35 OSHA recognizes
that the estimated compliance rates are somewhat imprecise, but they
are intended to reflect the relatively widespread adoption by employers
of some of the practices required by the ETS in response to state OSHA
standards, state and local government ordinances, and CDC, OSHA or
other guidance. Exceptions to the 50 percent/75 percent compliance
rates have been made for a few requirements that are highly specific to
OSHA's ETS (like recordkeeping requirements, rule familiarization, and
paid medical removal). While it is likely that levels of current
compliance vary among the elements of this ETS, OSHA lacks data to make
such specific determinations for each provision in the limited time
available under these emergency circumstances. OSHA examined the impact
of lower levels of baseline compliance on costs in a sensitivity
analysis (see section VI.B.III.q).
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\34\ The term ``baseline compliance'' is used to describe
protective workplace measures that would be conducted in the absence
of this ETS, the issuance of which establishes the meaning of and
the parameters for ``compliance.''
\35\ Note that the lower assumed compliance rate for very small
entities sometimes results in the presentation of higher costs for
very small entities than for larger entities. This result seems
counter-intuitive given that very small entities have fewer
employees than larger ones, and many of the costs in this analysis
are based on an average number of employees per entity. The very
small entities do, in fact, have lower costs when baseline
compliance rates are not taken into account. However, because OSHA
estimates that these employers are starting from a lower level of
current compliance, the tables, which incorporate baseline
compliance rates in their estimates, sometimes show higher (or only
negligibly lower) per-establishment costs for very small entities.
Another point on the tables which can seem counter-intuitive is that
average costs per establishment for the category ``all,'' which
includes large and very large entities (along with small and very
small entities) can be smaller (or not much larger) than for, say,
SBA-defined small entities. This is due, again, to the differing
compliance rates which can swamp, in the average, the higher costs
incurred by large and very large entities. Furthermore, because
there are often fewer large entities relative to the number of SBA-
defined small and very small entities in an industry, the average
costs for the smaller entities tend to result in lower average per
entity costs over ``all'' establishments than one might expect.
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Despite this estimated baseline compliance, employer compliance is
not so widespread, nor does it incorporate enough of the practices
required by this ETS, as to render this ETS unnecessary. As discussed
in Section V. Need for Specific Provisions of the ETS, OSHA emphasizes
that each of the infection control practices required by the ETS
provides some protection from COVID-19 by itself, but the controls work
best when used together, layering their protective impact to boost
overall effectiveness. The ``Swiss Cheese Model of Accident Causation''
(Reason, April 12, 1990) argues that each control has certain
weaknesses or ``holes.'' The ``holes'' differ between different
controls. By stacking several controls with different weaknesses on top
of one another, the ``holes'' are blocked by the strengths of the other
controls. In other words, if the controls are layered, then any
unexpected failure of a single control is protected against by the
strengths of other controls. This model also demonstrates the necessity
for high levels of compliance with all requirements of this ETS, since
failure to follow the requirements may leave the ``holes'' exposed and
lead to an increased risk of disease transmission in the workplace.
It should be noted that this analysis deals strictly with averages
and estimates. For any given establishment, actual costs may be higher
or lower than the point estimate shown here, but using an average
allows OSHA to evaluate feasibility by industry as required by the OSH
Act. In addition, OSHA has limited data on many of the parameters
needed in this analysis and has estimated them based on the available
data, estimates for similar requirements for other OSHA standards,
consultation with experts in other government agencies, and internal
agency judgment where necessary. OSHA's estimates are therefore based
on the best evidence available to the agency at the time this analysis
of costs and feasibility was performed.
Many ETS requirements result in labor burdens that are monetized
using the labor rates described in Section VI.B.III.a OSHA
differentiates per-establishment burden by establishment size for
large, SBA-defined small, and very small entities with fewer than 20
employees (which are a subset of SBA-defined small entities). In doing
so, OSHA accounts for the fact that, in most industries, a substantial
portion of the SBA-defined small entity population is also very small.
In most cases, OSHA assigned different unit cost burdens to entities
with fewer than 20 employees and to other SBA-defined small entities
(with 20 or more employees). Both of these groups are combined when
calculating average costs for all SBA-defined small entities.
OSHA estimates that approximately 563,000 entities have employees
who provide healthcare and healthcare support services and would be
subject to the requirements of the ETS, including approximately 749,000
establishments, and 10.3 million employees (see Table VI.B.3).
Section VI.B.III.a describes the wage rates used to estimate the
labor costs incurred by affected entities. Sections VI.B.III.b through
VI.B.III.o present the estimated costs for each of the requirements of
the ETS. Finally, section VI.B.III.p summarizes the total per-
establishment costs and total costs of the ETS.
a. Wage Rates
OSHA estimated occupation-specific wage rates from BLS 2018
Occupational Employment Statistics data (BLS, March 29, 2019). For each
affected NAICS industry, OSHA used the BLS (March 29, 2019) data to
estimate the average wages across the workers in the affected
occupations listed in Appendix VI.B.A. OSHA estimated loaded wages
using a fringe benefit rate of 44.4 percent, the average rate for all
civilian workers in the healthcare and social assistance industries in
the BLS (December 14, 2018) Employer Costs for Employee Compensation
data, as well as OSHA's standard estimate for overhead of 17 percent
times the base wage. The loaded wage rate averages by NAICS industry
and setting are presented in Appendix VI.B.B.
In addition to the wages of the healthcare providers and employees
in other covered occupations in the affected NAICS industries, the cost
analysis also uses an estimated wage rate for occupational health
specialists, training development specialists, and a blended wage rate
that reflects the mix of doctors and nurse practitioners.
[GRAPHIC] [TIFF OMITTED] TR21JN21.016
b. Rule Familiarization and COVID-19 Plan
ETS Requirements--Under Sec. 1910.502(c).
The employer must develop, implement, and update a COVID-19 plan
that addresses the hazards identified in the hazard assessment required
by this paragraph. The COVID-19 plan must include policies and
procedures that minimize the risk of transmission of COVID-19 for each
employee. This provision also requires employers to coordinate and
communicate with other employers at sites with multiple employers in
order to ensure that each employee is protected. Employers must have
policies and procedures to ensure that employees who enter into private
residences or other physical locations controlled by those not covered
by the OSH Act are protected. Non-managerial employees must be given
the opportunity to provide input into the hazard assessment and the
COVID-19 plan. The plan must be written if the employer has more than
10 employees. In order for an employer to be exempt from providing
certain controls for fully-vaccinated employees in a well-defined area
of a workplace where there is no reasonable expectation that any person
with suspected or confirmed COVID-19 will be present, the COVID-19 plan
must include policies and procedures to determine employees'
vaccination status.
This section of the feasibility analysis presents the estimated
costs for developing the plan, while the costs of implementing the plan
are presented in the subsequent sections (VI.B.III.c through
VI.B.III.o) of this report.\36\
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\36\ Estimates were based on the Infectious Diseases Panel
Report (ERG, August 9, 2013).
---------------------------------------------------------------------------
Cost Analysis Assumptions
As part of the Infectious Diseases Small Business Advisory Review
(SBAR) Panel, OSHA estimated that the development of a full Worker
Infection Control Plan (WICP) that included written standard operating
procedures for all infectious disease transmission routes would take
between 20 and 40 hours to develop, depending on the setting (OSHA,
2014). For this ETS, which applies specifically to COVID-19, OSHA
estimates that the written plan, including the hazard assessment, would
take 25 percent of the time needed to develop a full WICP. The
exception is hospitals, which are assumed to need 40 hours to develop
their plans. OSHA has not included additional time for employee
participation and assumes that the time estimated to develop the COVID-
19 plan is extensive enough to account for this activity. In addition
to the costs for developing the COVID-19 plan, OSHA assumes that
establishments with fewer than 20 employees will incur a labor burden
of 1 hour for rule familiarization and larger establishments will incur
a labor burden of 1.5 hours for rule familiarization.
OSHA also assumes an additional recurring daily labor burden to
monitor each workplace to ensure the ongoing effectiveness of the
COVID-19 plan. OSHA estimates this will take 10 minutes per day of
labor per large establishment on average, with 5 minutes per day for
SBA-defined small and very small entities. This burden is incurred
daily, seven days a week,\37\ for six months. OSHA notes that
surveillance on the efficacy of an infection control plan is not a
wholly new activity for healthcare settings (CDC, March 15, 2017). The
Core Infection Prevention and Control Practices for Safe Healthcare
Delivery in All Settings from the Healthcare Infection Control
Practices Advisory Committee (the federal advisory committee appointed
to provide advice and guidance to the Department of Health and Human
Services and CDC regarding the practice of infection control in
healthcare settings) includes performance monitoring as one of its core
elements. Specifically, healthcare providers should ``monitor adherence
to infection control practices'' and ``monitor the incidence of
infections . . . to detect transmission of infectious agents in the
facility'' (CDC, March 15, 2017). OSHA estimates that there will be
some additional burden due to the requirements of this ETS, but that it
would be a small amount of additional time added on to what is a
regular activity that would be undertaken regardless of the ETS.
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\37\ To the extent that businesses are open fewer than seven
days a week or do not have employees on the premises seven days a
week, there will be some tendency toward overestimating the cost of
complying with this provision.
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As part of the planning and on-going monitoring, some employers
will need to communicate with other employers whose employees are at
the site (e.g., contractors, vendors) about the specifics of their plan
and additional information as necessary on an on-going basis. OSHA
estimates that hospitals, nursing homes, and other long-term care
facilities will spend 30 minutes one time after the promulgation of
this ETS
to communicate with contractors and others regarding expectations for
their activities under the requirements of this ETS. Additionally, OSHA
estimates that hospitals, nursing homes, and other long-term care
facilities will spend, on average, 15 minutes every week engaging in
on-going communication with contractors under this provision. Other
settings are estimated to only rarely use contractors, and so their
time burden is set to zero for both initial and on-going communication.
The total cost for this communication for hospitals, long-term care
facilities, and nursing homes is a product of:
One-time labor burden (half an hour for applicable settings)
plus the on-going labor burden (0.25 hours weekly for 26 weeks)
Wage rate (NAICS-specific wages)
Cost per Establishment, Rule Familiarization and COVID-19 Plan
Table VI.B.8 presents a summary of the per-establishment rule
familiarization and COVID-19 plan development, daily monitoring, and
host employer communication time burdens and costs for all
establishments. The baseline compliance estimates in Table VI.B.8 are
based on the estimated compliance rates in ERG (August 9, 2013), the
infectious disease expert panel report prepared for OSHA, and adjusted
so that baseline compliance is no less than 50 percent for
establishments with fewer than 20 employees and no less than 75 percent
for larger establishments. The expert panel survey was done during non-
pandemic conditions, so OSHA assumes compliance may be higher in health
care settings today. See the introduction to this section for more
discussion. OSHA assumes zero current compliance for rule
familiarization. Table VI.B.9 presents the same costs as Table VI.B.8
by establishment size.
[GRAPHIC] [TIFF OMITTED] TR21JN21.017
[GRAPHIC] [TIFF OMITTED] TR21JN21.018
c. Patient Screening and Management
ETS Requirements--Under Sec. 1910.502(d)
In settings where direct patient care is provided, employers must
limit and monitor points of entry, screen and triage all non-employees
entering the setting, and implement other applicable patient management
strategies.
Cost Analysis Assumptions
As noted in Summary and Explanation (Section VIII of the preamble),
screening is a standard part of infection control practices. OSHA
expects that healthcare settings will ask about COVID-19 infections and
perform a quick check of existing symptoms or assessment for newly
emerged symptoms that might suggest the presence of a COVID-19
infection. This screening does not need to be a highly involved
procedure and can be completed through verbal questions and answers.
OSHA estimates the six-month incremental time burden per facility for
screening and triaging non-employees for COVID-19 illness and symptoms
of COVID-19 (for all establishments) as follows:
General Hospitals: An incremental burden of 385.1 hours is
estimated based on a burden of 1 minute per patient each day for an
average of 1 patient per employee \38\ and a baseline compliance rate
of 81 percent. [385.1 = (1-0.81) * (666.3/60) * (365/2); where 81% is
the compliance rate, 666.3 is the number of patients (estimated as
being equal to the average number of employees per establishment),\39\
60 is the number of minutes in an hour (which allows OSHA to calculate
the burden in hours per day), and 365/2 is the number of days of
burden]
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\38\ According to AHA Data Hub 2015-2019 data, there were
785,235,256 outpatient visits, 19,418,138 outpatient surgeries, and
34,078,100 admissions in 2019 (AHA, 2021). These data came from
5,141 community hospitals, which results in an average of 447 visits
per day for each hospital. Thus, since OSHA estimates there are 492
healthcare workers per hospital across all types of hospitals, that
is approximately 1 patient per employee per day.
\39\ The estimated average number of workers per hospital for
General Hospitals is greater than the average number across all
types of hospitals derived from the AHA data cited above.
---------------------------------------------------------------------------
Other Hospitals: An incremental burden of 60.4 hours is
estimated based on a burden of 1 minute per patient each day for an
average of 1 patient per employee \38\ and a baseline compliance rate
of 81 percent. [60.4 = (1-0.81) * (104.5/60) * (365/2); where 81% is
the compliance rate, 104.5 is the number of patients (equal to the
average number of employees per establishment), 60 is the number of
minutes in an hour (which allows OSHA to calculate the burden in hours
per day), and 365/2 is the number of days of burden]
Nursing Homes: An incremental burden of 20.4 hours is
estimated based on a burden of 1 minute per patient each day for an
average of 32 patients per facility \40\ and a baseline compliance rate
of 79 percent. [20.4 = (1-0.79) * (32/60) * (365/2); where 79% is the
compliance rate, 32 is the number of patients, 60 is the number of
minutes in an hour (which allows OSHA to calculate the burden in hours
per day), and 365/2 is the number of days of burden]
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\40\ The number of patients per facility for Nursing Homes and
other Long Term Care is estimated using a 2019 National Center for
Health Statistics study on long term care facilities and their
patients (Harris-Kojetin et al., February, 2019) and OSHA's
estimated number of facilities (estimated using BLS (May 23, 2018),
BLS (March 29, 2019), and U.S. Census Bureau (March, 2020)).
---------------------------------------------------------------------------
Long Term Care (excluding nursing homes): An incremental
burden of 14.7 hours is estimated based on a burden of 1 minute per
patient each day for an average of 23 patients per facility
40 and a baseline compliance rate of 79 percent. [14.7 = (1-
0.79) * (23/60) * (365/2); where 79 percent is the compliance rate, 23
is the number of patients, 60 is the number of minutes in an hour
(which allows OSHA to calculate the burden in hours per day), and 365/2
is the number of days of burden]
Other Patient Care: An incremental burden of 39.9 hours is
estimated as 30 minutes per day \41\ and a baseline compliance rate of
56 percent [39.9 = (1-0.56) * (30/60) * (365/2); where 56 percent is
the compliance rate, 30 is the minutes of burden per day, 60 is the
number of minutes in an hour (which allows OSHA to calculate the burden
in hours per day), and 365/2 is the number of days of burden]
---------------------------------------------------------------------------
\41\ The number of patients at hospitals and ambulatory care was
estimated using AHA Data Hub 2015-2019 data (AHA, 2021).
---------------------------------------------------------------------------
Correctional Facility Clinics: An incremental burden of 18.25
hours is estimated as 30 minutes per day and a baseline compliance rate
of 80 percent [18.25 = (1-0.80) * (30/60) * (365/2); where 80 percent
is the compliance rate, 30 is the minutes of burden per day, 60 is the
number of minutes in an hour (which allows OSHA to calculate the burden
in hours per day), and 365/2 is the number of days of burden]
The baseline compliance estimates are based on ERG (August 9,
2013), the infectious disease expert panel report prepared for OSHA. As
noted above, the rate of compliance with the patient screening and
management requirements was estimated to be relatively high prior to
the COVID pandemic. It is possible that these compliance rates are even
higher now, given the emphasis on screening for symptoms over the
course of the pandemic. However, while OSHA has estimated that those
settings that were judged to have very low compliance pre-COVID are
likely complying with screening requirements more thoroughly now, the
agency has not adjusted those settings with higher rates of patient
screening pre-COVID since the agency lacks data to make these
adjustments. The estimated time spent to screen patients is based on
the agency's evaluation of the time necessary to ask standard COVID
screening questions.
Cost per Establishment, Patient Screening and Management
Table VI.B.10 shows the average cost per establishment for patient
screening and management by setting and size and incorporates the
compliance rates as detailed above.
[GRAPHIC] [TIFF OMITTED] TR21JN21.019
d. Standard and Transmission-Based Precautions
ETS Requirements--Under Sec. 1910.502(e)
Employers must develop and implement policies and procedures that
adhere to standard and transmission-based precautions.
Cost Analysis Assumptions
OSHA estimates that any time spent on the development of policies
and procedures that are in accordance with standard and transmission-
based precautions is included in the cost of developing the COVID-19
plan discussed earlier. OSHA does not expect that employers will need
to deviate significantly from existing practice to account for these
precautions and practices, and any costs associated with following
standard and transmission-based precautions are covered under the cost
estimates for the other sections of this ETS (PPE, hygiene and
cleaning, etc.). Therefore, OSHA did not estimate the costs associated
with compliance with this provision separately.
e. Personal Protective Equipment
ETS Requirements--Under Sec. 1910.502(f)
Employers are required to provide facemasks and ensure those
facemasks are worn by each employee over the nose and mouth when
indoors and when occupying a vehicle with other people for work
purposes. Employers must ensure that each employee changes their
facemask at least once per day, whenever the facemask is soiled or
damaged, and more frequently as necessary (e.g., patient care reasons).
Employers must provide respirators and other PPE for workers exposed to
people with suspected or confirmed COVID-19, for employees involved in
aerosol-generating healthcare procedures on people with suspected or
confirmed COVID-19, and as necessary to comply with standard and
transmission-based precautions under paragraph (e). Required PPE
includes gloves, an isolation gown or protective clothing, and eye
protection.
Cost Analysis Assumptions
The total cost to establishments to provide PPE will vary based on
the type of care provided in a facility and the number of encounters
workers will have with patients during a given period. The cost of
implementing this PPE provision will also vary by the number of
employees and the number of patients that the facility sees, as well as
by whether employees are working with people who are suspected or
confirmed to have COVID-19. A small practice with few employees and low
patient volume may have very low costs for PPE while a large hospital
with hundreds of workers and patients on any given day will likely have
much higher costs for PPE.
For the purposes of estimating costs for this provision, OSHA is
assuming that 25 percent of covered employees in hospitals and nursing
homes (which corresponds roughly with the percent of covered workers
estimated to work in areas of a hospital where patients with suspected
or confirmed COVID-19 infections would be seen) and three percent of
in-scope employees in other covered settings (identified in section
VI.B.II.b as being in the scope) will be provided with, and use,
disposable N95 respirators. These estimates are based on OSHA's best
professional judgment. All other workers in covered settings are
estimated to use two disposable facemasks (surgical masks) per shift.
The general approach for estimating the total cost of PPE used by
employees who have exposure to persons with suspected or confirmed
COVID-19 involves the following steps:
1. Estimate the percentage of healthcare providers and employees
providing healthcare or healthcare support services in each setting
that will use each given type of PPE;
2. For each given type of PPE, estimate how many pieces of
equipment an employee will use over six months (e.g., estimate that
hospital workers need 1 N95 respirator per shift, work 3 shifts per
week on average, so they will need 78 N95 respirators over 6 months);
3. Estimate the unit cost for each PPE item; and
4. Calculate the product of (a) the number of covered employees,
(b) the percent that will use a given type of PPE (step 1), (c) the
number of items needed per affected worker over six months (step 2),
and (d) the unit cost (step 3).
Table VI.B.11 presents the estimated percentages of employees who
will need the required PPE by setting.
[GRAPHIC] [TIFF OMITTED] TR21JN21.020
Table VI.B.12 presents estimates for the units of PPE needed per
employee shift for the employees using a given type of PPE. OSHA
assumes that one N95 respirator and either one disposable face shield
\42\ or protective eyewear will be used per shift. The estimated number
of gowns and gloves needed per shift are based on estimates from Carias
et al., (April 10, 2015) and Swaminathan et al., (October, 2007).
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\42\ Employers may provide reusable face shields which may be
less costly on a per-use basis but require cleaning and storage
which are additional costs. As a simplifying assumption, OSHA has
assumed employers will provide disposable face shields which may
represent a source of overestimation of compliance costs.
[GRAPHIC] [TIFF OMITTED] TR21JN21.021
For general hospital, nursing homes, and long-term care facilities,
OSHA estimates that employees work three twelve-hour shifts per week,
or 78 shifts over six months. For other settings, OSHA estimates that
employees work five eight-hour shifts per week, or 130 shifts over six
months. Table VI.B.13 presents the total units of PPE per establishment
that would need to be used over a six-month period, by setting and
worker type. These estimates combine the numbers of covered workers by
setting with the percentages presented in Table VI.B.11, the pieces of
equipment needed from Table VI.B.12, and the number of shifts per
worker that occur over 6 months, and were adjusted for baseline
compliance (80 percent for general hospitals and nursing home
respirator costs, 90 percent for all other PPE in general hospitals and
nursing homes, and 72 percent for other settings).
[GRAPHIC] [TIFF OMITTED] TR21JN21.022
Table VI.B.14 presents the estimated PPE unit costs. Note that
these unit costs reflect typical costs when there is not a PPE
shortage.
[GRAPHIC] [TIFF OMITTED] TR21JN21.023
Cost per Establishment, Personal Protective Equipment
The results from Table VI.B.14 and Table VI.B.13 are combined to
estimate the per-establishment compliance costs of additional PPE
presented in Table VI.B.15.
[GRAPHIC] [TIFF OMITTED] TR21JN21.024
Cost Analysis Assumptions, Respiratory Protection Program
Under this section of the ETS, where employers are required to
provide respirators, they must be provided and used in accordance with
OSHA's Respiratory Protection standard (29 CFR 1910.134). Note that
costs related to optional respirator use under the mini respiratory
protection program (29 CFR 1910.504) are discussed in sections VI.B.IV
and VI.B.V below but are included in the total average costs presented
below in Table VI.B.20 below.
OSHA estimates that 15 percent of nursing home employers and 50
percent of employers in NAICS 621111 Offices of Physicians who do not
currently have a respirator program would either be required by the ETS
to implement a respiratory protection program or would voluntarily
determine that their employees need additional respiratory
protection.\43\ Of those establishments, OSHA estimates that, at most,
25 percent would, as a result of the requirements in this ETS, need to
establish a full program under Sec. 1910.134 and the remainder would
be able to take advantage of the mini respiratory protection program
under Sec. 1910.504 (see section VI.B.IV.b Scope of the Mini
Respiratory Protection section of the ETS below for additional detail).
In establishments that already have a respirator program, OSHA
estimates that the ETS will cause more employees to be wearing
respirators and their employers will incur the additional costs related
to medical evaluation, fit testing, and training for those employees.
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\43\ While OSHA has no hard data on how many establishments have
or will need to develop a respiratory protection program, the agency
has been assisting numerous nursing homes to establish programs over
the course of the pandemic. OSHA expects that some additional
nursing homes and long term care facilities will still need to
establish a program after the promulgation of this ETS but that most
will have done so already. While most offices of physicians would
not have needed a respiratory protection program prior to the
pandemic, OSHA's estimate for this element reflects an assumption
that healthcare providers may decide to be cautious given the close
proximity to others that is required in order to provide healthcare
services.
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In this section, OSHA is evaluating the costs for program
development, medical evaluation, fit testing, and training related to
respiratory protection. As stated above, OSHA is estimating costs
assuming that all affected employees will use disposable N95
respirators only.
Workers who need respiratory protection (i.e., those assumed to be
using N95 respirators) will need to have a medical evaluation, fit
testing, and training. These are one-time costs per affected worker.
That is, total costs are simply calculated as the number of affected
workers multiplied by the one-time per worker cost.
The estimated average numbers of workers per establishment affected
by respiratory protection requirements under the ETS are presented
below in Table VI.B.16.
[GRAPHIC] [TIFF OMITTED] TR21JN21.025
Table VI.B.17 presents the estimated percentage of baseline
compliance with the respiratory protection requirements by setting. The
baseline estimates are based on ERG (August 9, 2013), the infectious
disease expert panel report prepared for OSHA, but as explained in the
introduction to this section, are assumed to be at least 50 percent for
establishments with fewer than 20 employees and at least 75 percent for
larger establishments.
[GRAPHIC] [TIFF OMITTED] TR21JN21.026
The per worker labor burdens and costs include those associated
with the medical examination and the fit testing, which are described
below.
Respiratory Protection Plan Development
The respiratory protection standard requires employers to develop
and maintain a written respiratory protection program. OSHA estimates
that a physician or other licensed healthcare professional will spend 4
hours for establishments with fewer than 20 employees and 8 hours for
larger establishments (OSHA, 2018) to develop this plan.
Medical Evaluation
The Respiratory Protection standard requires employers to provide a
medical evaluation to determine the employee's ability to use a
respirator before the employee is fit tested or required to use the
respirator in the workplace. 29 CFR 1910.134(e)(1); (OSHA, 2018).
While OSHA's respiratory protection standard requires medical re-
evaluation under certain circumstances, OSHA believes that, given the
limited time this ETS will be in effect, there will not be sufficient
time for conditions to change and trigger the requirement for the re-
evaluation and therefore OSHA did not estimate any costs associated
with medical re-evaluation in this analysis.
The preliminary medical evaluation (medical questionnaire) is
estimated to take 15 minutes of the worker's time and 5 minutes of a
physician or other licensed health care professional's (PLHCP) time.
OSHA estimates that a follow-up medical evaluation is needed 23 percent
of the time (OSHA, 2018). When a follow-up medical evaluation is
needed, OSHA estimates that this has a cost of $391 plus the cost
burden for the 1 hour of the worker's time (OSHA, 2018). In addition,
it is estimated that a travel cost of $5 plus a half hour of the
worker's time is incurred for all settings
except for hospitals (since the follow-up is assumed to occur off-site
for employees in settings other than hospitals).
Fit Testing and Training
The Respiratory Protection standard requires that, before a worker
is required to use a respirator with a negative or positive pressure
tight-fitting face piece, the employee must be fit tested with the same
make, model, style, and size of respirator that will be used. Fit
testing costs and training are estimated as one hour of the workers
time, plus one half hour of the fit tester's time for fit testing, one
half hour per 10 employees of the fit tester's time for training, and
the cost of two N95 respirators (OSHA, 2018).
Summary of per Worker Respiratory Protection Costs
Table VI.B.18 summarizes how the per worker respiratory protection
costs are estimated.
[GRAPHIC] [TIFF OMITTED] TR21JN21.027
Cost per Establishment, Respiratory Protection
Table VI.B.19 presents a summary of the respiratory protection
costs per establishment, including plan development, fit testing,
training, and medical evaluation costs.
[GRAPHIC] [TIFF OMITTED] TR21JN21.028
Table VI.B.20 presents a summary of the average per establishment
combined cost for PPE and respiratory protection. The costs included in
Table VI.B.20 also include the costs associated with the
Mini Respiratory Protection Program described in section VI.B.V.0
[GRAPHIC] [TIFF OMITTED] TR21JN21.029
f. Aerosol-Generating Healthcare Procedures on a Person With Suspected
or Confirmed COVID-19
ETS Requirements--Under Sec. 1910.502(g)
When an aerosol-generating procedure is performed on a person with
suspected or confirmed COVID-19, the employer must limit the number of
employees present during the procedure to only those essential for
patient care and procedure support and ensure that the procedure is
performed in an existing airborne infection isolation room (AIIR), if
available. After the procedure is completed, the employer must clean
and disinfect the surfaces and equipment in the room or area where the
procedure was performed.
Cost Analysis Assumptions
Any costs associated with PPE or enhanced cleaning required under
this provision are included in the sections addressing PPE and cleaning
and disinfection. Costs associated with assuring properly functioning
AIIRs are considered in section VI.B.III.j on ventilation, below.
g. Physical Distancing
ETS Requirements--Under Sec. 1910.502(h)
The employer must ensure that each employee is separated from all
other people by at least six feet when indoors unless the employer can
demonstrate that such physical distancing is not feasible for a
specific activity. When six feet of distancing is not feasible, the
employer must ensure that the employees are as far apart as is
feasible. This provision does not apply to momentary exposure while
people are in movement (e.g., passing in hallways or aisles).
Cost Analysis Assumptions
To implement physical distancing requirements, OSHA assumes
employers post signage encouraging physical distancing: 25 Signs on
average per large establishment, with 15 and 10 signs for SBA-defined
small and very small establishments, respectively. OSHA estimated a
unit cost per sign of $0.10, with the assumption that employers will
use free downloadable signs from the CDC and self-print those signs.
OSHA also includes costs for floor markings, based on the unit cost for
a roll of masking tape ($4.39 (Office Depot, 2020)), and assuming 3
rolls per large establishments, 2 rolls per SBA-defined small
establishment, and 1 roll per very small establishments. OSHA also
assumes 2 minutes of labor per sign, including printing and
installation by an employee.
Cost per Establishment, Physical Distancing
Table VI.B.21 presents a summary of the physical distancing costs
per healthcare establishment, incorporating the baseline compliance
rates of 50 percent for very small entities and 75 percent for all
other entities. These include costs of the signs, the floor markings,
and the labor of installing them (calculated using the average loaded
wage shown in Appendix VI.B.B).
[GRAPHIC] [TIFF OMITTED] TR21JN21.030
h. Physical Barriers
ETS Requirements--Under Sec. 1910.502(i)
The employer must install cleanable or disposable, solid barriers
at each fixed work location outside of direct patient care areas where
each employee is not separated from all other people by at least 6
feet. An exception is made for where the employer can demonstrate that
it is not feasible.
Cost Analysis Assumptions
OSHA estimates that the ETS will result in additional clear plastic
barriers installed in 10 percent of general hospital, other hospital,
first aid and emergency care, and other patient care settings. Other
facilities in these settings are assumed to have installed these
barriers or an equivalent barrier prior to the ETS. OSHA estimates that
each setting will install 3 clear plastic barriers with a cost of $300
per barrier.\44\ This is an average. OSHA also assumes 15 minutes of
labor for 2 maintenance workers for the installation of each barrier.
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\44\ The cost of installing clear plastic barriers in response
to COVID-19 has been reported in the following news articles: (1)
Altoona company starts installing plexiglass cashier shields (Lim,
April 2, 2020)--$300 per barrier, and (2) Franklin County to get
prices on spit/sneeze shields, doors (Perry, April 21, 2020)--$140
per barrier. The higher cost estimate is utilized in the analysis.
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While OSHA has no data on the number of barriers that have been
purchased and installed or how many additional barriers will need to be
made, the agency has included what it has determined, based on agency
judgment, to be a reasonable estimate for this requirement. It is
likely that some workplaces will need more barriers than others; it is
also likely that many establishments will reevaluate their current
barrier set up as a result of this ETS and determine that they need
additional barriers. This is an average, so it also accounts for the
likelihood that some establishments will not need any barriers because
the nature of the work makes spacing feasible, or because barriers are
infeasible.
Cost per Establishment, Physical Barriers
Table VI.B.22 presents the average total physical barrier costs for
establishments covered by the ETS by setting and incorporates the
baseline compliance rate of 90 percent as discussed above for
hospitals, first aid and emergency care, and other patient care.
[GRAPHIC] [TIFF OMITTED] TR21JN21.031
i. Cleaning and Disinfection
ETS Requirements--Under Sec. 1910.502(j)
In patient care areas and resident rooms, and for medical devices
and equipment, the employer must follow standard practices for cleaning
and disinfection of surfaces and equipment in accordance with
applicable CDC guidelines. In other areas, the employer must clean
high-touch surfaces and equipment at least once per day. When an
employer is aware that a person who is COVID-19 positive has been in
the workplace within the last 24 hours, the employer must clean and
disinfect any areas, materials, and equipment under the employer's
control that have likely been contaminated by that person. The employer
must also provide alcohol-based hand rub or readily accessible hand
washing facilities.
Cost Analysis Assumptions
In settings other than hospitals, nursing homes, and long-term care
facilities, OSHA assumes establishments will, in addition to their
current cleaning product purchases, need to purchase a six-month supply
of multipurpose cleaners and disinfectants, at a cost of $4.54 for each
(i.e., a supply of multipurpose cleaner and a supply of disinfectants/
virucides), for a total of about $9 per establishment (W.B. Mason,
2020).
Hospitals are estimated to spend a total of $56 million annually on
soaps and cleaning products, and nursing homes and long-term care
settings are estimated to spend $60 million annually on these supplies
(BEA, November, 2018). OSHA estimates that spending on cleaning
products will increase by 5 percent as a result of the ETS, and
accounts for these increased cleaning product costs on a per employee
basis, which is equivalent to an additional $0.37 per hospital employee
and an additional $0.69 per nursing home and long-term care setting
employee. This increased spending also covers the costs of cleaning
associated with aerosol-generating procedures under paragraph (g) of
the ETS.
OSHA expects that the majority of cleaning that would need to be
done to comply with this provision is already being done in response to
CDC guidelines or could be completed in nonproductive downtime without
affecting worker productivity. Given the emphasis on cleaning and
disinfection in healthcare settings (those in NAICS 622), the agency
believes that all necessary cleaning is being done at healthcare
establishments. However, outside of NAICS 622, OSHA has included a time
burden of 2 additional minutes per shift for 25 percent of covered
workers, for cleaning, in order to err on the side of being overly
inclusive of costs.
This provision of the ETS also requires that the employer provide
alcohol-based hand rub (ABHR) or readily accessible hand washing
facilities. OSHA estimates that this ETS will result in a 10 percent
increase in the use of ABHR or an average incremental increase of
0.0067 ounces \45\ of hand sanitizer per use of ABHR (assumed to be 10
percent of the ABHR needed per use, which translates into a 10 percent
increase in use overall), with an estimated incremental cost of 0.335
cents per use.\46\ The estimated number of uses of ABHR is based on the
estimate for the number of gloves used (see Table VI.B.13), assuming
that there are two ABHR uses per pair of gloves used (i.e., using ABHR
before putting on and after taking off each pair of gloves).
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\45\ According to the makers of Purell, ``If used as directed,
which is to apply enough PURELL[supreg] Hand Sanitizer to thoroughly
cover hands, a consumer can get 29-30 uses out of a 2 fl. oz.
bottle''. Thus, OSHA assumes that each use of hand sanitizer would
be 2/30 = 0.067066667 fl oz. (GOJO US, 2020). Ten percent of
0.067066667 fl oz, is 0.0067 fl oz, which is the incremental
increase in ABHR use per use assumed to be attributable to the rule.
\46\ The cost of bulk hand sanitizer is estimated as $0.50 per
ounce (W.B. Mason, 2020).
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Cost per Establishment, Cleaning and Disinfection
Table VI.B.23 presents the average cleaning and disinfection costs
for healthcare establishments by setting and establishment size and
incorporates the baseline compliance rates of 50 percent for very small
entities and 75 percent for all other entities.
[GRAPHIC] [TIFF OMITTED] TR21JN21.032
j. Ventilation
ETS Requirements--Under Sec. 1910.502(k)
Employers who own or control buildings or structures with an
existing heating, ventilation, and air conditioning (HVAC) system, must
ensure that: The system is used in accordance with the manufacturer's
instructions and the design specifications; the amount of outside air
circulated through the system and the number of air changes per hour
are maximized to the extent appropriate; air filters are rated Minimum
Efficiency Reporting Value (MERV) 13 or higher, if compatible, or the
highest compatible filtering efficiency for the HVAC system(s); air
filters are maintained and replaced as needed; and intake ports are
cleaned, maintained, and cleared of debris. This provision does not
require installation of new HVAC systems or AIIRs to replace or augment
functioning systems. However, where an employer has an existing AIIR,
the AIIR must be maintained and operated in accordance with its design
and construction criteria. The regulatory text does include a note
encouraging additional ventilation measures; however, as they are not a
mandatory component of the ETS, costs have not been taken for those
additional measures.
Cost Analysis Assumptions
For all settings, OSHA assumes each establishment will need an
average of 3 MERV 13 air filters for large establishments, with 2 for
SBA-defined small businesses, and 1 for very small establishments. The
unit cost is $21.50 per filter (Home Depot, 2020).\47\ OSHA assumes
filters are replaced every three months, and this replacement requires
10 minutes of labor per filter for an Installation, Maintenance, and
Repair (SOC 49-0000) employee every three months. For hospitals with 20
or more employees OSHA assumed that a larger filter would be used, with
a unit cost of $79 (HD Supply, 2021) and a replacement labor burden of
20 minutes of labor per filter.
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\47\ Employers will need to upgrade to the highest efficiency
filter compatible with their existing system. To the extent
employers are upgrading to something less efficient than a MERV 13
filter, there will be some tendency toward overestimating costs.
---------------------------------------------------------------------------
While it is a good business practice to maintain the HVAC system in
good working order and OSHA believes that most establishments have HVAC
systems that meet the requirements of the ETS, OSHA estimates that some
small amount will need to have their HVAC systems serviced. In addition
to the cost of purchasing and installing new air filters, OSHA
estimates that large hospitals, nursing homes, and long-term care
settings will require four hours of a general maintenance and repair
worker's time to evaluate the condition of the HVAC system and to
complete any necessary maintenance. In all other settings, 30 percent
of large employers who need this maintenance will need 2 hours of
maintenance work and SBA-defined small employers who need this
maintenance will need 1 hour of maintenance work. OSHA assumes that
very small entities will be less likely to control the HVAC system in
their facility and therefore assigns no additional maintenance costs to
those establishments. Any necessary HVAC work could be done by an
outside source like an HVAC maintenance contractor or could be done by
in-house maintenance workers if they are available.
The draft infectious disease cost analysis prepared for SBREFA
included engineering control costs for hospitals to maintain AIIRs to
manufacturer's specifications (OSHA, 2014). These costs were updated to
current dollars for the analysis of this ETS. And while the infectious
disease cost analysis included both initial costs and annual
maintenance costs, since the ETS is only effective for six months, OSHA
included in this analysis only maintenance costs to bring existing
AIIRs up to the manufacturer's specifications where they are not
already being maintained properly. OSHA estimates that most hospitals
(83 percent) that have AIIRs properly maintain them (ERG, August 9,
2013).
Based on analyses performed in conjunction with OSHA's (1997)
proposed rule addressing occupational exposure to tuberculosis, 64 FR
54160 (Oct. 17, 1997), the agency estimates that there would be a one-
time cost of $8,143 to perform maintenance on an AIIR so that it
functions properly (e.g., maintains negative air pressure relative to
the surrounding areas, completes the recommended number of hourly air
exchanges) (WCG, November 14, 1994; updated to 2020 dollars). This is
based on an estimated cost per square foot to purchase and install
material, including ducting, fans, and HEPA filters, in an average
isolation room measuring 150 square feet (WCG, November 14, 1994;
updated to 2020 dollars). Note that since the analysis timeframe is 6
months, there are no on-going maintenance costs attributable to the
ETS.
Cost per Establishment, Ventilation
Table VI.B.24 presents the average ventilation costs for healthcare
establishments by setting and size. These estimates incorporate the
baseline compliance rates of 50 percent for very small entities and 75
percent for all other entities, and a baseline compliance rate of 83
percent for maintenance of AIIRs in hospitals.
[GRAPHIC] [TIFF OMITTED] TR21JN21.033
k. Health Screening and Medical Management
ETS Requirements--Under Sec. 1910.502(l)
The employer must screen each employee before each work day or
shift for COVID-19 symptoms and require employees to promptly notify
the employer when they are COVID-19 positive, have been told by a
healthcare provider that they are suspected to be COVID-19 positive, or
are experiencing certain specified symptoms of COVID-19. When an
employer is notified that a person who has been in the workplace is
COVID-19 positive, the employer must notify each employee who had, and
other employers whose employees had, close contact with that person in
the workplace. The employer must also notify any employee who worked
in, and any other employers whose employees worked in, a well-defined
portion of a workplace in which the COVID-positive person was present
during the potential transmission period.
This paragraph also contains a requirement that the employer
immediately remove any employee who is positive for COVID-19. Removal,
which in the ETS refers to temporary removal from the workplace, must
continue until that employee meets the criteria for return to work. In
addition, the employer must remove any employee who has been told by
their healthcare provider that they are suspected to have COVID-19 and
any employee who is experiencing certain COVID-19 symptoms. The
employer must ensure that any such employee is kept out of the
workplace until they either meet the return to work criteria or they
test negative for COVID-19 based on a polymerase chain reaction (PCR)
test, which the employer must provide at no cost to the employee. In
addition, the employer must remove any employee who has had close
contact with someone in the workplace who is COVID-19 positive (unless
the employee has either been fully vaccinated or has recently recovered
from COVID-19). Employees who had close contact must be removed for 14
days or until they test negative for COVID-19 via a test provided at
least 5 days after the exposure and paid for by the employer. Employees
who had symptoms or were informed by a licensed healthcare provider
they are suspected to have COVID-19, but did not have close contact,
can return to work immediately if they test negative. Employees removed
because of close contact must stay away from work for at least 7
calendar days from the date of exposure, even if they test negative.
When an employee is removed under the above criteria the employer
must continue to pay the employee's normal earnings, as though the
employee were still at their regular job, up to $1,400 a week for the
first two weeks. If employees remain sick after that first two-week
period and must stay out longer, employers with fewer than 500
employees are only required to pay two thirds of regular pay, up to
$200 per day, after the initial 10 working days. Pay during removal can
be offset with any employer or public benefits, such as paid leave or
workers' compensation, until the employee meets the return to work
criteria.\48\ The requirement to pay the employee terminates if the
employer offers a COVID-19 test at least five days after the exposure
and the employee refuses to take it. Employers may also require
employees who are removed from the workplace under this paragraph to
work remotely or in isolation when suitable work is available. These
employees would be paid as usual for their work. Employers with 10 or
fewer employees are required to remove employees from the workplace
under this paragraph but are not required to pay them during the time
they are removed.
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\48\ Recent legislation, the American Rescue Plan Act, Public
Law 117-2, section 9641, extends tax credits to many employers for
paid leave provided to employees through September 30, 2021 for
COVID-19 related reasons. These tax credits will cover leave
provided to employees removed from work under this ETS. This reduces
costs to employers by shifting those costs to taxpayers.
---------------------------------------------------------------------------
The ETS does not require notification or removal of employees who
were wearing respirators, along with other required PPE, at the time
they had close contact with a person with COVID-19. In addition, an
employee's close contact with a patient with COVID-19 does not trigger
the notification requirements (and therefore does not trigger removal
requirements) if the patient with COVID-19 was in an area where such
patients are normally expected, such as an emergency room or COVID-19
clinic (as opposed to a maternity unit of a hospital, a physician's
office that screens out COVID-19 patients, a physical therapist's
office, etc.).
Cost Analysis Assumptions
The health screening activities could include instructing employees
to perform a self-assessment for symptoms before they arrive to work.
The training on the elements of this self-assessment are included under
the cost of training and there is no cost to the employer for this
activity because it can be completed by the employee concurrent with
other
daily activities without taking time from those activities. Although
employers are not required to use temperature screening for employee
screening, OSHA assumes for purposes of this analysis that this may be
done as part of screening and estimates that it will take an average of
15 seconds per employee per day. OSHA also estimates that
establishments will purchase no-touch thermometers at a rate of 1 per
100 employees, on average, with a minimum of 1 per establishment and
unit cost of $29.50 per thermometer (Rice et al., December 18, 2020).
OSHA also includes 5 minutes of General and Operations Manager (OES
11-1020) labor per case (i.e., each employee required to notify their
employer) to make arrangements for the employee per above, and an
additional 40 minutes per case to notify other potentially exposed
employees. This includes the time to identify which of the exposed
employees would be excluded from the notification and removal
requirements because they were wearing respirators and required PPE at
the time of the exposure.
Cost per Establishment, Health Screening and Notification
In order to estimate the feasibility of the ETS and due to the
highly uncertain path of the pandemic over the period this ETS will be
in effect, OSHA examined feasibility based on historic numbers of cases
and fatalities from two periods: March 19, 2021 through April 19, 2021,
inclusive of the cases on the start and end dates (designated as the
``primary'' scenario) and a monthly average over April 1, 2020 through
April 1, 2021, inclusive of the start and end dates (called the
``alternative'' scenario). Using these scenarios, OSHA estimated cost
per establishment for the screening and notification requirements of
this provision under both scenarios. Costs per establishment are shown
below in Table VI.B.25 by setting and size. They incorporate the
baseline compliance rates of 50 percent for very small entities and 75
percent for all other entities.
[GRAPHIC] [TIFF OMITTED] TR21JN21.034
Medical Removal Protection and Medical Removal Protection Benefits
There are two types of costs that employers can incur to comply
with the ETS requirements for medical removal: Payments to employees
who are removed from work and payment for testing to determine whether
those employees can return to work. OSHA developed cost estimates for
medical removal protection (MRP) benefits for the two scenarios
described above in section VI.B.III.k, Health Screening and
Notification. The estimates for each scenario (primary and alternative)
follow the same procedure.\49\ In order to estimate the cost to
employers of providing MRP benefits to their workers, OSHA needed to
make the following estimates:
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\49\ The provisions for MRP have an exemption for all
establishments with 10 or fewer employees, so these establishments
are not included in calculating the cost of MRP benefits.
---------------------------------------------------------------------------
The number of workers who would need to be removed \50\
from the workplace;
---------------------------------------------------------------------------
\50\ Includes workers who have or are suspected to have COVID-19
illness, those diagnosed to have COVID-19 by a licensed healthcare
provider, those who have specified symptoms, and those who have had
close contact at work with someone who is COVID-19 positive (unless
they have no symptoms and have either been fully vaccinated or
recently recovered from COVID-19).
---------------------------------------------------------------------------
The number of removed workers who would be COVID-19
positive;
The number of workers who would receive a COVID-19 test,
the number of workers who would test negative for COVID-19, and the
cost to the employer of those tests;
The number of days COVID-19 positive employees and
employees who receive a negative COVID-19 test would be paid MRP
benefits;
The daily wage paid to removed workers;
The number of days that can be offset by other paid leave
benefits; and
The impact of the tax credit for paid sick leave included
in the American Rescue Plan Act (ARP), Public Law 117-2, assuming 100
percent take-up for all
qualifying firms (i.e., those with fewer than 500
employees).51 52
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\51\ In estimating the costs and feasibility of an OSHA
standard, OSHA assumes that employers behave rationally to minimize
their costs and thus assumes all eligible employers would take the
tax credit. The agency examines the impact of less than 100 percent
take-up of the tax credit in the sensitivity analysis in section
VI.C.XVII.
\52\ Note that certain government employers (mainly state and
local governments) are qualified for the tax credit regardless of
size.
---------------------------------------------------------------------------
Number of Workers Removed
The base number of COVID-19 cases among workers is determined based
on historic infection data. OSHA's calculations of the number of COVID-
19 cases among workers affected by this ETS, based on the two
scenarios, are shown in the benefits section of this analysis (see
section VI.B.VIII.d for details of those estimates).
As shown in Row A of of the Benefits section, OSHA identified
2,041,229 COVID-19 cases during the period of March 19, 2021 through
April 19, 2021, which serves as the basis for the ``primary'' scenario,
and 2,507,290 cases as the monthly average over the year beginning
April 1, 2020 and ending April 1, 2021, which serves as the
``alternative'' scenario.
As explained in the Benefits analysis, OSHA then adjusted that
number of cases by removing cases that were outside of the range of
working age adults (18-64 years) and then including a further reduction
to account for a percentage of that population that is not employed
(See Benefits, Rows B and C). Using the primary scenario as an example,
there were 1,047,145 remaining cases (See Benefits, Row C). OSHA then
removed an additional 228,797 cases to account for teleworkers, who in
this analysis do not receive any benefit from the ETS nor incur any
costs for the employer. The remaining number of cases (818,348, as
shown on Row E of Benefits) is one month of cases among workers
expected to be in the physical workplace. While OSHA begins its
analysis with the same data as presented in Benefits, the Benefits and
Cost analysis diverge at this point because the Benefits remove
additional cases to account for community spread (see, Row F), while
those cases are not removed for costs because employers will incur
removal costs for those workers regardless of whether they were
infected at work or elsewhere.
Because this analysis is examining the effect of six months of the
ETS, OSHA multiplied that 818,348 by six months to produce a product of
4,910,088 total cases of workers in the workplace over 6 months. Based
on OSHA's industry analysis, 13 percent of all employees in the
workforce are covered by 29 CFR 1910.502 (see the Benefits analysis).
OSHA assumes that the number of cases would be allocated according to
those percentages, so during the entire period of the ETS the number of
workers under the ETS who have COVID-19 are, respectively, 625,933
(primary), and 768,848 (alternative).53 54 In Table VI.B.26,
for convenience, OSHA presents the cases discussed in the following
text.
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\53\ Primary = 13% (rounded) of 625,933 cases in the workplace
over 6 months; Alternative = 13% (rounded) of 768,848 cases in the
workplace over 6 months.
\54\ The products are accurate--13 percent is a rounded number.
These numbers do not include teleworkers since they are not in the
workplace and hence do not qualify for MRP, but they do include
workers at the physical workplace who actually become infected
through community spread rather than at work.
[GRAPHIC] [TIFF OMITTED] TR21JN21.035
Like the benefits analysis, the cost analysis further reduces the
number of cases to account for vaccinations. Due to the prioritization
of healthcare workers for vaccinations, OSHA assumes a vaccination rate
of 75 percent for the healthcare sector.\55\ Since the original CDC
data reflect cases that occurred during periods with a reduced but
positive vaccination rate, the calculation to adjust the data for the
increase to a 75 percent vaccination rate is slightly complicated. It
is explained later in the Benefits section. The final result is that
for the primary scenario OSHA estimates that 62.9 percent of the cases
remain after all adjustments are incorporated, and for the alternative
scenario, 40.4 percent of cases remain. The reduction in the number of
cases prevented through vaccination ultimately means that fewer
employees will need to be temporarily removed from the workplace per
the requirements of the ETS (with a corresponding reduction in
benefits). OSHA thus estimates that under the primary scenario there is
an adjusted total of 393,662 COVID-19 cases (those cases remaining
after the additional number of cases are reduced to reflect cases
prevented by vaccination--75 percent) are removed: (625,933 *
0.629)). The adjusted number of cases under the alternative scenario is
310,637 (768,848 * 0.404).
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\55\ OSHA had no direct estimates of healthcare workers who have
been vaccinated but based this estimate on the following sources.
Workforce COVID-19 vaccination rates among 8 top U.S. hospitals
(Masson, February 22, 2021) found vaccination rates of about 60 to
85% among hospital personnel in February 2021. Early COVID-19 First-
Dose Vaccination Coverage Among Residents and Staff Members of
Skilled Nursing Facilities Participating in the Pharmacy Partnership
for Long-Term Care Program--United States, December 2020-January
2021 (Gharpure et al., February 5, 2021) found vaccination rates of
about 37.5% among nursing home staff. Given the time that has passed
since these studies and the fact that, in the benefits analysis,
there is no way to determine job category or industry, OSHA believes
an overall rate of 75 percent for healthcare workers is a reasonable
average for the job categories and industries being considered here.
---------------------------------------------------------------------------
Finally, the agency adjusts MRP cases to account for a gradual
reduction in the need for MRP as the comprehensive protections of the
standard lower the number of transmissions at the workplace (e.g.,
working with distance or barriers, etc.). Most other costs of the ETS
do not include this type of adjustment because they are not dependent
on reductions in workplace transmission (e.g., barriers would still be
required regardless of whether some workplace transmissions are
prevented). As in the Benefits analysis, OSHA assumes that the
effectiveness rate in the workplace will be an overall 75 percent,
meaning that 75 percent of the infections would be prevented over the
6-month course of the ETS. The final number of cases for the primary
scenario is therefore reduced to 98,445 (393,662 * (1-0.75)), and for
the alternative scenario it is reduced to 77,659 (310,637 * (1-0.75)).
Note that the effectiveness would be higher except that OSHA assumes,
as it does in Benefits, that 20 percent of the cases will be worker
infections resulting from community transmission outside the workplace
and therefore not reduced by the provisions of the ETS. However, unlike
Benefits, those community spread cases are not subtracted from the
total number of remaining cases because the employers will still bear
the same cost for addressing them as if the worker had been infected at
the workplace. For example, whether the employee was infected in the
workplace or outside the workplace, once the employer learns that the
employee has tested positive for COVID-19 the employer must still
remove that employee from the workplace in order to protect its other
employees and must provide MRP benefits to the removed employee.
OSHA estimates that in half of these cases (49,208 for the primary
scenario) workers will know they are COVID-19 positive through a COVID-
19 test or via diagnosis by a licensed healthcare provider of suspected
or confirmed COVID-19 (OSHA assumes this group diagnosed by a
healthcare provider is then confirmed by a positive test). The other
half will have symptoms as described in the ETS (before being tested
and confirmed positive).
Beyond the positive cases, other workers will need to be removed
from the workplace because they are exposed to someone at the workplace
who has COVID-19, or develop the symptoms specified in Sec.
1910.501(i)(2)(iii) or (iv), even though they are not actually infected
with COVID-19 and ultimately test negative (but must still be
temporarily removed from the workplace pending the testing results). To
estimate this number of removed workers, OSHA assumes that for every
worker who has symptoms and who will eventually test positive for
COVID-19 there will be an equal number (49,208 for the primary
scenario) of workers who will have symptoms but who will test negative
and not be infected (Kim et al., Jan 25, 2021, Tostmann et al., April
23, 2020). OSHA further assumes that for every potential COVID-19 case
reported to an employer (based on a test, diagnosis, or symptoms) there
will be 1.5 workers who will have close contact at work with a person
with COVID-19.\56\ The ETS exempts workers who are wearing respirators
and other required PPE from being removed due to close contact with a
person with COVID-19. OSHA assumes 25 percent of the workers are
wearing N95 respirators and the other required PPE (section VI.B.III.e
of this analysis) and therefore would not need to be notified of such
contact nor removed from work as a result of it. This is support for
the assumption that on average 1.5 people covered by the ETS will need
to be removed because they have close contact with an infected person
at work. Thus, focusing just on the primary scenario from above for the
purposes of illustration, with 98,415 COVID-19 cases there will be an
additional 147,263 workers (98,415*1.5) who would need to be removed
from work because they had close contact at work with someone who has
COVID-19.
---------------------------------------------------------------------------
\56\ OSHA examines the effects of varying this assumption in a
sensitivity analysis (see section VI.B.III.q).
---------------------------------------------------------------------------
Number of Workers Who Would Receive a COVID-19 Test
When testing is an option, OSHA expects employers to have employees
tested so that the employees can return to their work as quickly as
possible. For workers with suspected COVID-19 illness with symptoms,
which includes cases diagnosed by a licensed healthcare provider that
are then tested and found to be negative, the employer can offer the
test immediately. If the test is negative, the worker can immediately
return to work upon receipt of the test results. If the test is
positive, the employee would continue removal according to either
guidance from a licensed healthcare provider or CDC's isolation
guidance.
For workers who are removed due to close contact, OSHA has made
several assumptions. Workers removed due to close contact with a
primary worker who is COVID-19 positive will either be removed for 14
calendar days or the employer can provide a COVID-19 test 5 days after
the workplace exposure. If the results of the test are negative, the
worker removed due to close contact can return to work 7 calendar days
after exposure. If the results of the test are positive, the worker
will continue for the full removal of 14 days. The cost of the test is
estimated to be a $10 administrative fee plus $5 in travel costs (this
is an average--some employees will not require any travel
reimbursement, while others may have higher travel costs); all other
costs of testing are assumed to be borne by insurance or other third-
party payers. Note that for testing after an employee is removed there
is no need to factor in lost work time because the employee is not
working and is already compensated for that time.
Number of Days of MRP Benefits
If a worker is COVID-19 positive, OSHA assumes they will be removed
from the workplace on average for 10 working days,\57\ based on
following CDC guidelines on isolation days and accounting for the
severity of the cases.\58\ The CDC guidelines recommend 10 calendar
days minimum for isolation absent a continued fever.
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\57\ OSHA acknowledges that some workers do not work a standard
5-day work week but, for the purposes of this analysis, the agency
assumes all employees who will be removed under MRP do so.
\58\ See CDC (February 18, 2021).
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Workers who are removed from work before they know if they have
COVID-19 fall into two groups: Workers who are removed because they
have specific symptoms, and workers removed because they have been in
close contact with someone at work who is COVID positive. For workers
in this first group (with symptoms) who are provided tests by their
employers but test negative, OSHA estimates they will be tested on the
first day they are removed and will be removed from work for an average
of two days. For workers in the second group, who are removed due to
close contact with a COVID-19 case in the workplace, the employer may
provide the employee with a test at least five days after the exposure
to the COVID positive employee. The regulatory text (paragraph
(i)(4)(iii)(2)(i) also states that an employee removed due to close
contact who tests negative can return to work after 7 calendar days
from exposure. OSHA therefore estimates that employees in the second
group (removed due to having close contact) will be tested five days
after exposure and, if their test comes back negative, they will return
to work after 7 calendar
days (which translates to 5 working days of paid removal).
If their test comes back positive, OSHA assumes employees in both
groups (symptoms and close contact) will on average complete the
remainder of a 10-working day (14 calendar days) period of removal
before returning to work.\59\
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\59\ As support for an average of 14 calendar days for isolation
OSHA drew on several studies to estimate this average based on a
breakdown of cases to asymptomatic, mild/moderate, severe without
hospitalization, and severe with hospitalization. First is the
equation, showing shares of various cases multiplied by their
expected days out, and then an explanation of each term:
(17% * 10) + (66.4% * 12) + (7% * 20) + (9.6% * 35.5) [ap] 14
calendar days.
Where broken down term by term: The first term is asymptomatic
cases where CDC guidelines have a minimum of 10 calendar days for
isolation (CDC, March 12, 2021). The seventeen percent is from
Byambasuren et al., (December 11, 2020). The second term is for mild
to moderate cases which may need a couple of extra days above the
minimum of 10 days (CDC, March 12, 2021). The 66.4 percent comes
from a study finding that approximately 80 percent of symptomatic
COVID-19 cases are mild to moderate (Wu and McGoogan, April 7,
2020). That 80 percent was multiplied by the remaining cases after
removing the asymptomatic cases: (0.8 * (1-0.17) = 0.664). The last
term is for hospitalizations, where the total of 35.5 days is from
both a study by Emory University that found second surge
hospitalization cases had an average length of stay as 8.2 days
(Meena et al., March 1, 2021) and another study that found that the
median number of days to return to work after hospitalization was 27
days (Chopra et al., November 11, 2020). The 9.6 percent is from
Grave Danger (Section IV.A. of this preamble). Finally, the third
term is for severe, but without hospitalization, cases, where the
maximum number of days CDC expects is 20 days (CDC, March 12, 2021).
The 7 percent is the percentage left for severe without
hospitalization after subtracting out the percentages for other
types of cases.
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Daily MRP Benefits Paid to Removed Workers
The ETS includes a $1,400 weekly cap on MRP payments, except that
employers with fewer than 500 workers need not pay more than $200 per
day (\2/3\ of the worker's regular pay, up to $200 per day) after the
first two weeks. Since OSHA uses average wage rates in this analysis,
this analysis necessitated the calculation of a truncated average wage
with a weekly limit of $1,400 as prescribed in paragraph
(i)(5)(iii)(A). The wage data used for this analysis do not have the
kind of detail needed to calculate an exact truncated average wage, so
the agency employed a relatively rough estimate using the median,
rather than the average, wage (since with right-tailed data like wage
distributions the median is below the mean) and then truncating the
median wage at $1,400 for a full-time, 40-hour work week, if needed.
This maximum wage is therefore $35 an hour ($1400/40). Note that this
may overestimate the costs given that wages are capped at \2/3\ of
regular pay (up to $200/day) after the first two weeks for employers
with fewer than 500 workers.
Other Paid Leave Offsetting MRP Benefits
OSHA also considered how much of the MRP payments can be offset by
other payment sources. For this analysis, OSHA only considered the
availability and cost offset due to sick leave and payroll tax credits
for qualifying leave payments made for removal that are part of the
recently enacted ARP (see Pub. L. 117-2, section 9641).
For this analysis, OSHA assumed a 100 percent take-up of the tax
credit for sick leave paid under provisions in the ARP for all eligible
employers (i.e., establishments with fewer than 500 employees) while
these provisions are in effect. Hence, for firms with fewer than 500
employees, all the wage costs associated with providing MRP benefits
are assumed to be zero while the credits are available. These tax
credits will generally be claimed on employers' tax returns, which in
most cases are filed quarterly, although employers may be able to
access funds early in anticipation of claiming the credits. The agency
estimates that approximately three months of the ETS will be in place
while the ARP tax credit will not be unless the tax credit is extended
(these ARP provisions are currently slated to cover leave provided
through September 30, 2021) and so OSHA includes \3/6\ of MRP costs to
account for the three months of costs that would not be reimbursed
through the tax credit.
For cases where the employer applies an employee's sick leave to
days where the employee is both removed from work and is unable to work
at home, OSHA calculated the average number of sick days the employee
will have at the time of the removal and deducted those days in
calculating the wage payments the employer makes. BLS data show that,
overall, 78 percent of workers have access to paid sick leave with an
average length of available leave of 8 days.60 61 Assuming
workers have used, on average, 50 percent of their available paid sick
leave for other reasons by the time the leave is needed during the ETS,
the average employee would have 3.12 days of paid sick leave available
(0.78 * 0.5 * 8). Because there is the possibility of multiple removal
periods for a single individual (in which case the worker would likely
have no sick leave available the second time), OSHA adjusted the
available paid sick leave days per worker down from 3.12 to 3 days.
Hence, for workers who are removed for symptoms or close contact and
tested but ultimately found to not be infected, employers will not have
to pay any quarantine wage costs if the employees are out 3 work days
or fewer. If they are out longer, the employer would have to pay for
each of the days the employee is out after the first 3 work days. For
example, if an employee who was removed for a total of 7 days and
tested negative, the cost to the employer would be for 4 days of
removal following the 3 days of sick leave. For employees who are
COVID-19 positive and must be removed from the workplace for 10 work
days (14 calendar days), the employer will incur costs to pay wages to
those employees for 7 work days, on average, after adjusting for the 3
days of sick leave. The analysis assumes that employers will either
take the tax credit or apply employee sick days to offset medical
removal costs. Because it does not calculate the additional savings
available to the employer if it both applies employee sick days and
takes the tax credit, the estimate of the offsets available may be an
underestimation.
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\60\ See Scalia and Beach (September, 2020), Tables 31 and 34.
These data include a breakdown by employment size class: For
employment 1-49, 7 days leave and 66% access to leave rate;
employment 50-99, 7 and 76%; employment 100-499, 8 and 83%;
employment 500+, 9 and 90%. (Days of leave is for 5 years of
service. Both 1 year and 10 years are also shown, where days of
leave are usually the same, at most differing by one day.)
\61\ While smaller employers may offer less sick leave than
average, the exact amount of sick leave workers have available does
not impact the estimated costs of this provision because the tax
credit will entirely offset the cost of MRP benefits.
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While workers' compensation insurance might offset some costs under
this provision, OSHA did not consider any reduction in costs to
employers due to this insurance. The workers' compensation system
differs by state so it is hard to generalize the overall offset of this
insurance. Some states have moved towards mandating payment for COVID-
19 quarantines for certain types of workers (first responders, health
care) but, at this point, there are few such mandates in place and
generally workers' compensations systems have been reluctant to pay
claims for COVID-19 illnesses.\62\ To the extent that workers'
compensation payments are available to workers removed due to COVID-19,
the costs to employers estimated in this analysis will be overstated.
---------------------------------------------------------------------------
\62\ For one overview from the National Conference on State
Legislatures see Cunningham (December 9, 2020).
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Due to a lack of sufficient data, OSHA has assumed no baseline
compliance
with MRP benefits. To the extent that employers are currently paying
for workers with suspected or confirmed COVID-19 infections to take
leave, this analysis would have some tendency to overstate the cost of
this provision.
An important caveat is that this analysis deals strictly with
averages and estimates: OSHA has made no attempt to model clustering of
infections. Over the year prior to this ETS, there have been multiple
incidents where multiple employees in a single workplace were infected,
but the methodology in this analysis assumes independence across
infections. This means that the cost and feasibility determinations do
not consider situations where a single employer has multiple infections
among their employees. Conversely, in a situation where infections are
clustered, that would mean that, since some employers would be seeing
more cases among their employees than the average, other employers
would have a below-average number of, or even zero, infections. The
effects of modeling clusters of infections on industry-wide feasibility
are unclear, but OSHA believes a methodology that assumes the average
number of infections for all employers is reasonable as part of the
analysis supporting the feasibility of this ETS.
OSHA also notes that, from the standpoint of an analysis that
estimates the costs and benefits to society, much of MRP benefits would
be considered a transfer payment from one party to another, which is
not actually a cost to society as a whole. Since this analysis is
focused on determining economic feasibility, which involves a
determination of costs borne by employers, the nature of these payments
is not taken into account.
This analysis also does not attempt to forecast the course of the
pandemic or the effect this ETS will have on the pandemic. To the
extent that the historical data do not represent the course of the
pandemic over the period the ETS is in effect, and that various
interventions alter the course of the pandemic beyond the adjustments
made for vaccination status, these costs may be overstated or
understated.
Cost per Establishment, Medical Removal Protection and Medical Removal
Protection Benefits
Costs per establishment for medical removal and medical removal
protection benefits are shown below in Table VI.B.27.
[GRAPHIC] [TIFF OMITTED] TR21JN21.036
l. Vaccination
ETS Requirements--Under Sec. 1910.502(m)
The employer must support COVID-19 vaccination for each employee by
providing reasonable time and paid leave (e.g., paid sick leave,
administrative leave) to each employee for vaccination and any side
effects experienced following vaccination.
Cost Analysis Assumptions
The ETS does not require any employer to make a vaccine available
to employees.
Based on the discussion in section VI.B.III.k, OSHA estimates that,
on average, employees will have three days of paid sick leave available
before the employer has to pay any additional cost for sick leave. This
leave will be more than enough to cover the time needed to receive a
vaccine and any needed time off to recover from the side effects of the
vaccine.\63\ Therefore, OSHA estimates that employers will incur no
costs under this provision.\64\
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\63\ See CDC (2021b), Possible Side Effects After Getting a
COVID-19 Vaccine (explaining that vaccine side effects should go
away in a few days and some people have no side effects at all).
\64\ In addition, OSHA notes that, to the extent individual
employees do not have sufficient available paid sick leave to cover
this time, ARP allows employers with fewer than 500 employees to
recover the costs for the paid time they must provide, via tax
credits. Although this funding applies only to leave provided
through September 2021, OSHA anticipates that most workers who
decide to get vaccinated will have done so before then, particularly
in healthcare where most employees became eligible for vaccination
earlier and current vaccination rates are higher than in the rest of
the workforce. Although non-governmental employers with 500 or more
employees are not eligible for the tax credits under ARP, employees
of large employers are also more likely to have paid sick time
available to them. See Scalia and Beach (September, 2020),
``National Compensation Survey: Employee Benefits in the United
States, March 2020,'' BLS, Bulletin 2723, September 2020, Tables 31
and 34. As noted above, this source indicates that for employers
with 500 or more employees, 90% of employees have access to sick
leave, with an average of 9 days available. These figures are higher
than for smaller employers; for example, 66% of employees in firms
with 1-49 employees have paid sick leave, with an average of 7 days
of leave.
---------------------------------------------------------------------------
m. Training
ETS Requirements--Under Sec. 1910.502(n)
Employers must ensure that each employee receives training, in a
language and at a literacy level the employee understands, on topics
such as: COVID-19 transmission, symptoms, and ways to reduce risk;
patient screening and management; and workplace tasks and situations
that could result in COVID-19 infection. The training must also cover
employer policies and procedures related to preventing the spread of
COVID-19; PPE; cleaning and disinfection; health screening and medical
management, including medical removal; and sick leave. Employees must
be provided with information on multi-employer agreements related to
infection control and on the employer's COVID-19 plan, as well as the
identity of the safety coordinator for the COVID-19 plan. Additional
training is required whenever changes occur that affect the employee's
risk, policies or procedures are changed, or there is an indication the
necessary skill or understanding was not retained. The employer must
also inform employees about the anti-retaliation requirements under
paragraph (o).\65\ Finally, the employer must ensure that the training
is conducted by a person knowledgeable about the covered subject
matter, and that employees being trained have an opportunity to ask
questions and get answers from a person knowledgeable about the covered
subject matter.
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\65\ Although the requirement to provide employees with
information about the anti-retaliation provision is in a separate
paragraph from the other training requirements (see paragraph (o)),
OSHA assumes that employers will include it as an element of their
training program to comply with the ETS and is including it with the
other requirements of paragraph (n) for cost purposes.
---------------------------------------------------------------------------
Cost Analysis Assumptions
Based on the infectious disease expert panel report (ERG, August 9,
2013), OSHA estimates that training is already being provided 84
percent of the time for workers in hospitals, 68 percent of the time
for workers in home healthcare, and 74 percent of the time for workers
in long-term care and nursing homes. Estimates of current compliance
were constrained to be no lower than 75 percent for large or SBA-
defined small entities or 50 percent for very small entities in other
settings, as explained in the introduction to this section.
The costs include those associated with the training development
and providing the training to employees, as discussed in the sections
below.
OSHA estimated for the infectious diseases SBAR Panel that it would
take a total of 30 hours for the individual who would be training
workers exposed to infectious agents to develop training materials. And
the initial training was estimated to take either two or three hours,
depending on the job tasks of the workers.
OSHA estimates that developing training materials and providing
training under this ETS will take less time than the training required
under the infectious diseases draft regulatory framework since that
training was more extensive. This ETS also allows training completed
prior to the effective date of the ETS to count towards compliance,
provided it meets the relevant training requirements under this
section. OSHA estimates that, for large establishments, hospitals,
nursing homes, and long-term care settings of all sizes, it will take
\2/3\ of that 30-hour estimate to develop training materials under this
ETS; it will take \1/2\ or slightly less than \1/2\ of 30 hours for
SBA-defined small entities (15 hours for hospitals, nursing homes, and
long-term care settings and 12 hours for other settings); and very
small entities will need 7 hours to develop their training materials.
OSHA also estimates that it will take \1/2\ the time for employees to
receive the training. Delivering the training to workers is estimated
to take between 1 and 1.5 hours depending on the job tasks of the
workers.
As described above, development of the training materials is
assumed to be a one-time cost burden between 7 and 20 hours per
establishment, depending on size and type of facility. The cost per
establishment to develop this training is estimated as the product of
the one-time labor burden and wage rate ($52.73 for a training
development specialist). The baseline adjustments discussed are then
applied to these costs.
OSHA estimates the training cost burden assuming 1.25 hours (i.e.,
the average of 1 hour and 1.5 hours) for each covered employee's time
and an average of 12 employees in each instructor-led training session
(i.e., about 0.1 hours of the instructor's time per covered employee,
estimated at the cost of a training development specialist's loaded
wage or $52.73 per hour).
The total training development costs are estimated as the product
of:
The number of establishments affected; and
The average cost per establishment.
The total costs to deliver training are estimated as the product
of:
The number of workers covered; and
The average cost per worker who receives the training.
Baseline compliance rates for the various settings were described
previously in this section.
Cost per Establishment, Training
The average per-establishment costs of training are summarized in
Table VI.B.28.
[GRAPHIC] [TIFF OMITTED] TR21JN21.037
n. Recordkeeping
ETS Requirements--Under Sec. 1910.502(q)
Employers with more than 10 employees must establish and maintain
records, including all versions of the COVID-19 plan, and a COVID-19
log to record each instance identified by the employer in which an
employee has COVID-19. Employers must also make those records available
to specified individuals, and OSHA, upon request. Employers with 10 or
fewer employees on the effective date of this standard are not required
to comply with this paragraph.
Cost Analysis Assumptions
OSHA assumes 0.5 hours of labor from a General and Operations
Manager (SOC 11-1020) to establish a COVID-19 log. For each COVID-19
case, OSHA assumes 10 minutes of labor from an Information and Records
Clerk (SOC 43-4000) to record the case in the employer's COVID-19
log.\66\ As noted above in section VI.B.III.k, OSHA estimated the costs
for provisions that are dependent on the number of COVID-19 infections
based on numbers of cases under both a primary and an alternative
scenario. Using these data, OSHA calculated the number of cases per
establishment that will need to be recorded under both scenarios, along
with the associated cost.\67\
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\66\ This is comparable to the requirements in the Infectious
Diseases Small Business Regulatory Enforcement Fairness Act Panel
Report (OSHA, January 12, 2015), which estimates that employers
would spend 15 minutes generating and filing exposure incident
records. Note that the draft Infectious Diseases rule presented to
the Panel included more extensive reporting requirements than what
is being required under this ETS.
\67\ See section VI.B.III.k. for additional details.
[GRAPHIC] [TIFF OMITTED] TR21JN21.038
Cost per Establishment, Recordkeeping
Table VI.B.29 presents the average recordkeeping costs for covered
establishments by setting and incorporates the baseline compliance
rates of 50 percent for very small entities and 75 percent for all
others.
o. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
ETS Requirements--Under Sec. 1910.502(r)
The employer must report each work-related COVID-19 fatality within
8 hours of learning about the fatality and each work-related COVID-19
in-patient hospitalization within 24 hours of learning about it. When
reporting work-related COVID-19 fatalities and in-patient
hospitalizations to OSHA, the employer must follow the requirements in
29 CFR 1904.39, except for 29 CFR 1904.39(a)(1) and (2) and Sec.
1904.39(b)(6).
Cost Analysis Assumptions
OSHA assumes 45 minutes of labor from a General and Operations
Manager (SOC 11-1020) to report each hospitalization or fatality. While
this is higher than the 30 minutes estimated to be necessary to report
other fatalities or hospitalizations to OSHA,\68\ OSHA's estimate of 45
minutes is intended to account for any potential complexities in
determining the work-relatedness of COVID-19 fatalities and
hospitalizations. In existing OSHA enforcement guidance, issued in May
of 2020,\69\ OSHA offers several ``considerations'' for determining
whether an employer has made a reasonable determination of work-
relatedness:
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\68\ See OSHA (January 24, 2019), Supporting Statement for the
Information Requirement on Recordkeeping and Reporting Occupational
Injuries and Illnesses (29 CFR part 1904).
\69\ See OSHA (2020), Enforcement Memo: Updated Interim
Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19)
---------------------------------------------------------------------------
The reasonableness of the employer's investigation into
work-relatedness,
The evidence available to the employer, and
The evidence that a COVID-19 illness was contracted at
work.
Under that first consideration, OSHA says:
Employers, especially small employers, should not be expected to
undertake extensive medical inquiries, given employee privacy concerns
and most employers' lack of expertise in this area. It is sufficient in
most circumstances for the employer, when it learns of an employee's
COVID-19 illness, (1) to ask the employee how he believes he contracted
the COVID-19 illness; (2) while respecting employee privacy, discuss
with the employee his work and out-of-work activities that may have led
to the COVID-19 illness; and (3) review the employee's work environment
for potential SARS-CoV-2 exposure. The review in (3) should be informed
by any other instances of workers in that environment contracting
COVID-19 illness.
Based on this guidance, and the fact the healthcare employers
covered by the ETS are typically used to making work-relatedness
determinations for OSHA reporting purposes, OSHA believes 45 minutes
likely overstates the average time necessary to comply with the
reporting provisions.
OSHA calculated costs for this provision based on the numbers of
fatalities among healthcare workers under the primary and alternative
scenarios. Hospitalizations were estimated based on the ratio of
hospitalizations to fatalities reported by CDC of about 8.4
hospitalizations for each fatality.\70\ Based on these parameters, OSHA
estimates the cost of reporting per establishment under both
scenarios.\71\
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\70\ See CDC (April 29, 2021). Feb. 2020-Dec. 2020 4.1 million
hospitalizations. Feb. 2020-Dec. 2020 344,836 Fatalities.
\71\ See section VI.C.XI.e. for additional details.
\72\ OSHA assumes zero compliance for reporting COVID-19-related
in-patient hospitalizations because OSHA's standard reporting
requirements, see 29 CFR part 1904.39, only require reporting of in-
patient hospitalizations when they occur within 24 hours of the
work-related incident. 29 CFR part 1904.39(b)(6). Because
hospitalization for reasons related to COVID-19 is unlikely to occur
within 24 hours of a workplace exposure to COVID-19, reporting of
these cases by employers was probably sporadic. OSHA assumes its
standard levels of compliance with the reporting requirement for
fatalities in this ETS because COVID-19-related fatalities were more
likely to occur within the timeframe specified in 29 CFR part
1904.39(b)(6), which is 30 days from the date of the work-related
incident (exposure). To the extent employers were already reporting
COVID-19-related hospitalizations, OSHA's estimate of zero baseline
compliance would overestimate costs.
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Cost per Establishment, Reporting COVID-19 Fatalities and
Hospitalizations to OSHA
Table VI.B.30 presents the average reporting costs for covered
establishments by setting, incorporating the baseline compliance rates
for reporting fatalities of 50 percent for very small entities and 75
percent for all others. No baseline compliance is assumed for reporting
of hospitalizations.\72\
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TR21JN21.039
p. Total Costs
Table VI.B.31 summarizes the total costs per establishment across
covered establishments. Table VI.B.32 presents the total costs across
all establishments for the primary scenario.
[GRAPHIC] [TIFF OMITTED] TR21JN21.040
[GRAPHIC] [TIFF OMITTED] TR21JN21.041
BILLING CODE 4510-26-C
q. Sensitivity Analyses
OSHA considered two sensitivity analyses in order to consider
alternative values for selected parameters used in the cost analysis
for which there was greater uncertainty. The following sensitivity
analyses are presented below in Table VI.B.33 (all establishments),
Table VI.B.34 (SBA-Defined small establishments), and Table VI.B.35
(very small establishments with fewer than 20 employees):
Sensitivity Analysis 1: Costs estimated assuming a lower
take-up rate for the tax credit available for paid leave that would
apply to paid removal (75 percent and 50 percent take-up rates for
establishments with 100-499 and <100 employees, respectively, instead
of the 100 percent take-up rate for these establishments under the
primary estimate).
Sensitivity Analysis 2: Costs estimated with double the
number of assumed close contacts with COVID-19 positive workers (3
close contacts per infection instead of 1.5).
[GRAPHIC] [TIFF OMITTED] TR21JN21.042
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TR21JN21.043
[GRAPHIC] [TIFF OMITTED] TR21JN21.044
BILLING CODE 4510-26-C
IV. Mini Respiratory Protection Program
a. Introduction
In this section, OSHA provides estimates of the number of affected
entities, establishments, and employees for the industries that will
establish a respirator program in accordance with Sec. 1910.504, the
mini respiratory protection program section of the ETS.\73\
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\73\ Although there are two additional sections of this ETS--
Sec. 1910.505 Severability and Sec. 1910.509 Incorporation by
Reference--neither imposes duties on employers independent of Sec.
1910.502. Therefore, OSHA estimates no separate costs for compliance
with these sections.
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Throughout this analysis, where estimates were derived from
available data those sources have been noted in the text. Estimates
without sources noted in the text are based on agency expertise.
b. Scope of the Mini Respiratory Protection Program Section
This section of the ETS is applicable when employers provide
respirators, or allow employees to provide their own respirators,
instead of a facemask. The mini respiratory protection program section
applies to respirator use not covered by OSHA's respiratory protection
standard at Sec. 1910.134. While no employer is required to establish
a respiratory protection program under this section of the ETS, OSHA
assumes that some employers will take advantage of the mini respiratory
protection program and opt to provide a higher level of respiratory
protection to their workers. OSHA estimates that 50 percent of NAICS
6216 Home Health Care Services, 37.5 percent of NAICS 621111 Offices of
Physicians, and 37.5 percent of NAICS 623 Nursing and Residential Care
Facilities will establish a program under this section of the ETS.
c. Affected Entities and Employees
Table VI.B.36 below shows the entities and employees affected by this section of
the ETS.
[GRAPHIC] [TIFF OMITTED] TR21JN21.045
V. Cost of the Mini Respirator Program
a. Wage Rates
OSHA used occupation-specific wage rates from BLS 2018 Occupational
Employment Statistics data (BLS, March 29, 2019) to calculate hourly
wage costs. Within each affected 6-digit NAICS industry, OSHA
calculated the employee-weighted average wage to be used in the
analysis. OSHA estimated loaded wages using industry-specific fringe
benefit rates for all civilian workers as reported in the BLS 2018
Employer Costs for Employee Compensation data, as well as OSHA's
standard estimate for overhead of 17 percent times the base wage (BLS,
December 14, 2018).
b. Respirators Provided by Employees
ETS Requirements--Under Sec. 1910.504(c)
Where employees provide and use their own respirators, the employer
must provide each employee with a specified notice (provided in the
regulatory text) detailing proper protocols and warnings.
Cost Analysis Assumptions
OSHA estimates that time spent by employers to comply with this
provision will be negligible and the notice required can be provided as
part of the training required under 1910.502(n). Because this provision
is applicable when employees provide their own respirators, OSHA is not
including any cost for respirators.
c. Respirators Provided by Employers
ETS Requirements--Under Sec. 1910.504(d)
Where employers provide respirators to their employees, the
employer must ensure that employees receive specified training. The
employer must also ensure that employees who use tight-fitting
respirators perform a user seal check each time a respirator is put on
to achieve a proper seal, and ensure that problems discovered during
the seal check are corrected. The employer must also ensure that a
single filtering facepiece respirator used by a particular employee is
reused only by that employee and only under the conditions specified.
Reuse of single use respirators is discouraged. When there are medical
signs and symptoms related to an employee's ability to wear a
respirator, the employer must require that employee to discontinue use
of the respirator.
Cost Analysis Assumptions
OSHA estimates that, in order to comply with this provision,
employers will provide training to employees using respirators under
this provision. OSHA estimates that it will take 30 minutes to deliver
the training to employees with 10 employees per training session. The
labor burden for providing the training is estimated using the same fit
tester's wage rate used in section VI.B.III.e. OSHA also includes a
one-time cost of 10 minutes per employee for the initial user seal
check demonstration. The cost for N95 respirators is accounted for in
section VI.B.III.e--PPE.
OSHA has included no baseline compliance in estimating the cost of
this provision (i.e., a zero percent current compliance rate) since
this is a new option for respiratory protection that employers would
not currently be implementing absent this ETS.
Cost per Establishment
Table VI.B.37 below shows the estimated cost per establishment for
establishments affected by this requirement.
[GRAPHIC] [TIFF OMITTED] TR21JN21.046
VI. Economic Feasibility Determination
a. OSHA's Screening Tests for Economic Feasibility
To determine whether a rule is economically feasible, OSHA
typically begins by using two screening tests to determine whether the
costs of the rule are beneath the threshold level at which the economic
feasibility of an affected industry might be threatened. The first
screening test is a revenue test. While there is no hard and fast rule
on which to base the threshold, OSHA generally considers a standard to
be economically feasible for an affected industry when the annualized
costs of compliance are less than one percent of annual revenues. The
one-percent revenue threshold is intentionally set at a low level so
that OSHA can confidently assert that the rule is economically feasible
for industries that are below the threshold (i.e., industries for which
the costs of compliance are less than one percent of annual revenues).
To put the one percent threshold into perspective, in healthcare and
healthcare support industries, prices (and therefore revenues) are
generally observed to change by well more than one percent per year,
indicating that firms are able to withstand such changes.\74\ In other
words, in many industries, prices (and therefore revenues) are
generally observed to change by well more than one percent per year,
indicating that firms are able to withstand such changes.
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\74\ See BLS (June 3, 2021) BLS's CPI medical care index.
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The second screening test that OSHA traditionally uses to consider
whether a standard is economically feasible for an affected industry is
if the costs of compliance are less than ten percent of annual profits
(see, e.g., OSHA's economic analysis of its Silica standard, 81 FR
16286, 16533 (March 25, 2016); upheld in N. Am.'s Bldg. Trades Unions
v. OSHA, 878 F.3d 271, 300 (D.C. Cir. 2017)). The ten-percent profit
test is also intended to be at a sufficiently low level so as to allow
OSHA to identify industries that might require further examination.
Specifically, the profit screening is primarily used to alert OSHA to
potential impacts on industries where the price elasticity of demand
does not allow for ready absorption of new costs (e.g., industries with
foreign competition where the American firms would incur costs that
their foreign competitors would not because they are not subject to
OSHA requirements). In addition, setting the threshold for the profit
test low permits OSHA to reasonably conclude that the rule would be
economically feasible for industries below the threshold. To put the
ten-percent profit threshold test into perspective, evidence used by
OSHA in its 2016 OSHA silica rule indicates that, for the combined
affected manufacturing industries in general industry and maritime from
2000 through 2012, the average year-to-year fluctuation in profit rates
(both up and down) was 138.5 percent (81 FR 16545).\75\
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\75\ Profits are subject to the dynamics of the overall economy.
Many factors, including a national or global recession, a downturn
in a particular industry, foreign competition, or the increased
competitiveness of producers of close domestic substitutes are all
easily capable of causing a decline in profit rates in an industry
of well in excess of ten percent in one year or for several years in
succession (OSHA, March 25, 2016). Final Economic and Regulatory
Flexibility Analysis for OSHA's Rule on Occupational Exposure to
Respirable Crystalline Silica, Chapter VI, p. VI-20.
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When an industry ``passes'' both the ``cost-to-revenue'' and
``cost-to-profit'' screening tests, OSHA is assured that the costs of
compliance with the rule are economically feasible for that industry.
Most of the healthcare and healthcare support industries covered by the
ETS fall into this category.
A rule is not necessarily economically infeasible, however, for the
industries that do not pass the initial revenue screening test (i.e.,
those for which the costs of compliance with the rule are one percent
or more of annual revenues), the initial profit screening test (i.e,
those for which the costs of compliance are ten percent or more of
annual profits), or both. Instead, OSHA normally views those industries
as requiring additional examination as to whether the rule would be
economically feasible (see N. Am.'s Bldg. Trades Unions v. OSHA, 878
F.3d at 291). OSHA therefore conducts further analysis of the
industries that ``fail'' one or both of the screening tests in order to
evaluate whether the rule would threaten the existence or competitive
structure of those industries (see United Steelworkers of Am., AFL-CIO-
CLC v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980)).
b. Time Parameters for Analysis
OSHA's economic analyses almost always measure the costs of a
standard on an annual basis, conducting the screening tests by
measuring the cost of the standard against the annual profits and
annual revenues for a given industry. One year is typically the
minimum period for evaluating the status of a business; for example,
most business filings for tax or financial purposes are annual in
nature.
Some compliance costs are up-front costs and others are spread over
the duration of the ETS; regardless, the costs of the rule overall will
not typically be incurred or absorbed by businesses all at once. For
example, the initial capital costs for equipment that will be used over
many years are typically addressed through installments over a year or
a longer period to leverage loans or payment options to allow more time
to marshal revenue and minimize impacts on reserves.
The compliance costs for this ETS are for a temporary rule of a
limited duration. While the costs of an ETS are only incurred during
that duration, making the examination of costs over a six-month period
expected for the ETS the logical analysis, OSHA believes most
healthcare providers are likely to pay for those costs in installments
when possible in order to minimize cash-flow effects and allow more
time to replenish initial outlays for compliance with the rule.
Using one year of revenues and profits as the denominators in the
cost-to-revenue and cost-to-profit ratios would have resulted in ratios
that are half of the estimated ratios presented in this analysis. Under
that approach, none of the industries would have exceeded the revenue
screen, and only 10 industries would have triggered the profit or
revenue screen.
Nevertheless, faced with some uncertainty about how a given court
might view an analysis involving separate time periods of cost and
revenue/profits, and with only a limited amount of time to complete the
economic analysis for this emergency rule, OSHA determined that there
was not time to conduct a full screening analysis based on both annual
profits and revenues as well as a full screening analysis on a shorter
6-month time period. While OSHA believes the most appropriate screens
would be based on annual profits and revenue, it has followed the more
cautious route of basing the screens on 6 months of profits and revenue
to avoid any potential uncertainty about whether the ETS is
economically feasible for the affected sectors. It is therefore
unsurprising that businesses in a greater number of NAICS industries
exceed the thresholds under this measurement, and OSHA believes that
edging above the screening thresholds is less of an indicator of
economic peril in this context than in the context of a typical
rulemaking analysis. Nevertheless, OSHA has examined each of the NAICS
that did not clear either of these conservative screening tests and has
concluded that the ETS is economically feasible for each one.
c. Data Used for the Screening Tests
The estimated costs of complying with the ETS, which OSHA relied
upon to examine feasibility based on the two tests described above, are
presented, for each provision of the ETS, in section VI.B.III. (see
summary of total costs by establishment in Table VI.B.38). The revenue
numbers used to determine cost-to-revenue ratios were obtained from the
2017 Economic Census. This is the most current information available
from this source, which OSHA considers to be the best available source
of revenue data for U.S. businesses.\76\ OSHA adjusted these figures to
2019 dollars using the Bureau of Economic Analysis's GDP deflator,
which is OSHA's standard source for inflation and deflation analysis.
To account for the economic effects of the pandemic beginning in 2020,
and provide a more reasonable estimate of revenues for the period in
2021 during which the ETS will be in effect, the agency used other
national datasets to derive percentage changes to the baseline data.
Those sources and the method used for adjusting revenues are described
in more detail in Appendix VI.B.D.
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\76\ For information regarding the standards and practices used
by the Census Bureau to ensure the quality and integrity of its
data, see, e.g., U.S. Census Bureau (August 2, 2018).
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The profit screening test for feasibility (i.e., the cost-to-profit
ratio) was calculated as ETS costs divided by profits. Profits were
calculated as profit rates multiplied by revenues. The before-tax
profit rates that OSHA used were estimated using corporate balance
sheet data from the 2013 Corporation Source Book (Internal Revenue
Service, 2013). The IRS discontinued the publication of these data
after 2013, and therefore the most current years available are 2000-
2013.\77\ The most recent version of the Source Book represents the
best available evidence for these data on profit rates.\78\
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\77\ See IRS (2013).
\78\ OSHA also investigated Bizminer and RMA as potential
sources of profit information and determined that they do not
represent adequate and random samples of the affected industries.
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For each of the years 2000 through 2013, OSHA calculated profit
rates by dividing the ``net income'' from all firms (both profitable
and unprofitable) by total receipts from all firms (both profitable and
unprofitable) for each NAICS. OSHA then averaged these rates across the
14-year (2000 through 2013) period. Since some data provided by the IRS
were not available at disaggregated levels for all industries and
profit rates, data at more highly aggregated levels were used for such
industries; that is, where data were not available for each six-digit
NAICS code, data for the corresponding four- and five-digit NAICS codes
were used. Finally, although profit rates were determined using data
from the two previous decades, the profit calculations have been
adjusted, as described in Appendix VI.B.D of this economic analysis, to
reflect declining revenues--and therefore declining profits (profits =
profit rate * revenues) during the pandemic. Profit rates are expressed
as a percentage and are reported in Table VI.B.38, below. Profits
themselves were used to calculate the cost-to-profit estimates, which
are also reported in Table VI.B.38, below.
OSHA has estimated costs over a 6-month timeframe for this ETS. As
discussed above, OSHA has therefore used six months of revenue to
conduct the cost-to-revenue tests and six months of profit to conduct
the cost-to-profit tests.
d. Expected Healthcare Industry Responses to New Temporary Costs
In general, ``[w]hen an industry is subjected to a higher cost, it
does not simply swallow it; it raises its price and reduces its output,
and in this way shifts a part of the cost to its consumers and a part
to its suppliers.'' Am. Dental Ass'n v. Sec'y of Labor, 984 F.2d 823,
829 (7th Cir. 1993). This summary by the Seventh Circuit is in accord
with microeconomic theory. In the face of new compliance costs (or
other external costs), firms that otherwise have a profitable line of
business may have to increase prices to stay viable. Increases in
prices typically result in reduced quantity demanded, but rarely
eliminate all demand for the product. Depending on the cost and profit
structure of individual firms within the industry, a decrease in the
total production of goods or services may result from smaller output
for each establishment within the industry; the closure of some plants
within the industry; a reduced number of new establishments entering
the industry; or a combination of the three.
Whenever demand is relatively inelastic, employers facing new costs
typically can pass them along to customers and thereby avoid economic
harm to their business. To understand the point about the price
elasticity of demand, some economic background is needed. The price
elasticity of demand
refers to the relationship between the price charged for a product or
service and the quantity demanded for that product or service: The more
elastic the relationship, the larger the decrease in the quantity
demanded for a product when the price goes up. When demand is elastic,
establishments have less ability to pass compliance costs on to
customers in the form of a price increase and must absorb such costs in
the form of reduced profits. In contrast, when demand is relatively
inelastic, the quantity demanded for the product or service will be
less affected by a change in price. In such cases, establishments can
recover most of the variable costs of compliance (i.e., costs that are
highly correlated with the quantity of output or service) by raising
the prices they charge; under this scenario, if costs are variable
rather than fixed, business activity and profit rates are largely
unchanged by small changes in costs. Ultimately, any impacts are
primarily borne by those customers who purchase the relevant product or
service for a slightly higher price. A large percentage of the costs of
this ETS are variable costs because they depend primarily on the number
of employees at an establishment.\79\
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\79\ While fixed cost can be more limiting in terms of options
for businesses, most of the costs of this rule are not fixed.
Instead, most of the compliance costs vary with the level of output
or employment at a facility.
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Increases in fixed costs can also be passed along, but with a
likely reduction in output. A reduction in output could happen as a
result of delayed entry of new firms into the industry or the reduction
in the level of service or production by individual incumbent
establishments, which in healthcare could take the form of a reduction
of worker hours and/or fewer appointments. Some marginal establishments
could close, but healthcare providers as a group are more likely to be
insulated from that level of economic jeopardy.
It is important to note at the outset that the infection control
measures necessary for patient safety and worker safety are
substantially the same measures and thus included in the reimbursable
costs for patient care activities. The agency also notes that the
healthcare industry was able to absorb similar types of costs without
significant issues when OSHA implemented its Bloodborne Pathogens rule
(56 FR 64004 (Dec. 6, 1991)), which also required hazard assessment and
similar PPE. OSHA expects healthcare providers will have a number of
options for passing along or addressing any cost increases associated
with the ETS. First, where health care providers are reimbursed by
private health insurers for a percentage of a charge, small increases
in charges such as those that would result from the ETS can be
implemented quickly and the increase will be distributed between the
insurer and the patient (Williams and Saine, December 14, 2015). Even
larger charge increases could be implemented after negotiation with
insurers. In either case, the distribution of the price increase makes
it less likely that any price increases from this rule would
significantly impact demand.
Second, the federal government has already taken steps to provide
economic assistance to any healthcare providers that have difficulty
passing along costs increases to patients and insurers because of
COVID-19. Pursuant to the CARES Act, Public Law 116-136 (March, 2021),
and the COVID Provider Relief Fund, HHS is distributing $178 billion to
hospitals and healthcare providers ``on the front lines of the
coronavirus response,'' which are the providers the ETS focuses on
(HHS, January 21, 2021). Providers who participate in Medicare have
been eligible for loans through the Medicare Accelerated and Advance
Payment Programs, which helps providers facing cash flow disruptions
during an emergency (Kaiser Family Foundation, April 20, 2021).
Medicare has also authorized increased payments to address COVID care
needs, which are often the same as the worker protections required by
the ETS (more facemasks, respirators, gloves, etc.) (Id.)
Third, some health care providers, including some long-term care
facilities, have simply added ``COVID fees'' to directly cover the
increased cost of facemasks and other COVID-19 related worker
protections. (Paavola, November 5, 2020).
Further, the temporary nature of the ETS and its associated costs
suggests that firms may have more flexibility to respond than when
facing a permanent increase in costs. For example, firms may be able to
temporarily increase prices or temporarily defer planned capital
expenditures or other maintenance to cover compliance costs.
When all establishments in an affected industry are covered by a
rule and have to comply with the rule, none of the competitors gain any
economic advantage from the rule and the ability of a competitor to
offer a substitute product or service at a lower price is greatly
diminished. In this case, all the firms in the industry will try to,
and generally be able to, pass on most of the costs of the rule in
increased prices and revenues rather than in reduced profits. The scope
of the ETS is so broad that nearly all firms in nearly all industries
that provide healthcare or healthcare support services (at least those
OSHA examined due to exceeding the threshold for either the revenue or
profit test) would be covered, with the result that even substitution
of a service by a different industry is very unlikely.
Turning now to the specifics of the ETS and giving an advance
summary of the results of the industry investigations that follow all
of the industries that exceed the initial profit or revenue screening
test to determine economic feasibility provide a domestic service that
is not subject to international competition. Thus, in those industries,
competition from establishments that are not also subject to this ETS
and its related costs is unlikely. Because this indicates that entities
in these industries will likely be able to pass most of the costs of
the rule on to customers (patients) in the form of increased prices,
their profits will not be much affected by the ETS.
e. Limitations of Economic Screens
As with other OSHA rulemaking efforts, the agency relies on the two
screening tests (costs less than one percent of revenue and costs less
than ten percent of profit) as an initial indicator of economic
feasibility. Both have their limits in use, and the profit screen in
particularly is subject to several limitations.
First, as previously noted, OSHA has been using corporate balance
sheet data from the IRS as the best available evidence for estimating
corporate profits for years.\80\ Nevertheless, because firms typically
have an incentive to minimize their tax burden, it is reasonable to
expect that some of the reported accounting data may have been
strategically adjusted to reduce reported profits and their associated
tax implications. Business profits are particularly amenable to such
accounting manipulations (relative to business revenues), which can
reduce the accuracy of reliance on profits alone
as a measure for evaluating economic feasibility.\81\
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\80\ OSHA funded and accepted a final report by Contractor Henry
Beale (Beale Report, 2003) that reviewed alternative financial data
sources and concluded that the IRS data were the best. Since then
OSHA has been relying on IRS data to provide the financial data to
support its rulemaking analyses. See, for example, Occupational
Safety and Health Administration (OSHA) (March 25, 2016), Final
Economic and Regulatory Flexibility Analysis for OSHA's Rule on
Occupational Exposure to Respirable Crystalline Silica, Chapter VI,
pp. VI-2 to VI-3, Docket No. OSHA-2010-0034-4247, which includes a
more recent review of data sources for corporate financial profit
data and further support for OSHA's choice of IRS data.
\81\ In fact, all other Department of Labor agencies rely solely
on revenues to assess economic impacts, such as for Regulatory
Flexibility Act certifications, in their rulemakings (see, e.g.,
Employment and Training Administration, Final Rule on Strengthening
Wage Protections for the Temporary and Permanent Employment of
Certain Aliens in the United States; Wage and Hour Division, Tip
Regulations Under the Fair Labor Standards Act (FLSA)).
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Second, and most importantly, the profit test has a fairly limited
function in the economic analysis for this particular rule because it
functions primarily as a screen for a limited purpose: Alerting OSHA to
potential impacts where a high price elasticity of demand will prevent
firms from passing costs along to customers. In particular, the profit
screen test is primarily used to alert OSHA to potential issues with
foreign competition or substitution of goods that could threaten to
disrupt an industry, but neither of those are serious considerations
for the provision of healthcare services in the U.S. subject to the
ETS. The fact that some healthcare provider groups exceed the profit
screen does not mean that there is necessarily an issue of foreign
competition or substitution; it just alerts OSHA of the need to look
more closely.
These issues are discussed further in the sections below as part of
OSHA's examination of the feasibility for particular industries.
VII. Economic Feasibility Analysis: All Establishments
The preceding discussion has been abstract and technical. This
section summarizes OSHA's feasibility findings for specific industries
covered by section 1910.502. As stated previously, the agency uses the
two screening tests (costs less than one percent of revenue and costs
less than ten percent of profit) as an initial indicator of economic
feasibility. However, for this ETS the cost-to-revenue test appears to
be the more reliable indicator of feasibility for the industries
covered by the ETS. In this section, OSHA discusses the industries that
fall above the threshold level for either screening test.
OSHA is aware that the economic climate in which this ETS has been
promulgated is unique, and that many employers and their workers have
been under considerable economic strain for the past year or more.
While some healthcare providers were undoubtedly in that group to the
extent that patients avoided elective services in accordance with CDC
recommendations, the decrease in profits and revenues they experienced
resulted to a large extent from their businesses' inability to service
their customers' and patients' needs because of COVID-19-related safety
issues, rather than a decrease in the demand for their products. On the
other hand, some larger healthcare providers, such as hospitals,
experienced significant increases in demand because of the pandemic.
OSHA has designed the ETS with a flexible approach that provides
options for full and partial scope exemptions to control their costs
while protecting workers as demand increases for their services as the
economy continues to reopen and vaccination becomes increasingly
prevalent.
Table VI.B.38, ``Screening Analysis for all Establishments'' shows
that for the majority of covered NAICS industries, the cost-to-revenue
and cost-to-profit ratios are below both of OSHA's screening
thresholds. Only four six-digit NAICS are estimated to have costs in
excess of one percent of revenues, ranging from a high of 1.46 percent
for NAICS 621310 (Offices of Chiropractors) to 1.05 percent for NAICS
621399 (Offices of All Other Miscellaneous Health Practitioners): The
four industries that exceed the revenue screen are:
1. NAICS 621310--Offices of Chiropractors, 1.46 percent;
2. NAICS 621112--Offices of Physicians, Mental Health Specialists,
1.14 percent;
3. NAICS 621330--Offices of Mental Health Practitioners (except
Physicians), 1.09 percent;
4. NAICS 621399--Offices of All Other Miscellaneous Health
Practitioners, 1.05 percent.
There are several reasons why the ETS will still be economically
feasible for these industries. First, and most critically, the four
NAICS industries for which costs are above the revenue screen all
provide ambulatory care, typically in non-hospital settings. Healthcare
providers in non-hospital ambulatory care settings can avoid the costs
of complying with the ETS simply by performing screening for COVID-19
and preventing people with suspected or confirmed COVID-19 from
entering their facility (see paragraph (a)(2)(iii)). Many providers in
the four NAICS industries that are above the revenue threshold are
likely already taking these actions. If an employer determines that
complying with the rule would cause financial hardship for its
business, that employer could choose to institute these simple policies
and procedures for screening and preventing patients with suspected or
confirmed COVID-19 from entering the facility. OSHA anticipates that
most establishments in the four NAICS industries that are above the
revenue screen will be exempt from the ETS, as there is no regular need
for providers like chiropractors and mental health care specialists to
care for patients who have COVID-19. Those providers who are not
already screening out patients with COVID-19 infections or symptoms may
choose to begin doing so if they have concerns about covering the costs
of complying with the ETS. Therefore, because it is so simple to for
employers in these industries to avoid the costs of the ETS, OSHA finds
that on that basis alone the ETS is inherently feasible for these
industries.
Second, even to the extent that some of these establishments choose
to care for patients with COVID-19, they will likely be a small segment
of these industries. Providers that choose not to screen out patients
with suspected or confirmed COVID-19, and incur the costs to comply
with the ETS, will likely do so because they would be providing a niche
service with sufficient economic incentives to enable them to pass the
costs of compliance on to their COVID-19 patients or to those patients'
insurers. These industries provide domestic services and are not
subject to international competition; in addition, all similarly
situated ambulatory care health care providers would be subject to the
ETS to the extent that they treat COVID-19 patients, so there would be
no opportunity to substitute that service for COVID-19 patients for a
cheaper one by switching providers.
Finally, for mental health practitioners in NAICS 621112 and NAICS
621330, there is the additional option of providing telehealth services
in many cases. This telehealth option would also permit employers to
avoid the costs of complying with the ETS (see Sec.
1910.502(a)(2)(vii). Although the Dingel & Neiman study (Dingel and
Neiman, July 9, 2020) indicated a lack of telework/telemed options,
likely because of medical licensing and legal restrictions on providing
distanced care, that study was performed before the pandemic began.\82\
Since the study was conducted, there has been a significant loosening
of restrictions on the provision of mental health services through non-
geographic settings. On March 6, 2020, the Coronavirus Preparedness and
Response Supplemental Appropriations Act was signed into law. That
statute gave the Secretary of Health and Human Services (HHS) the
authority to waive geographic and originating site Medicare telehealth
reimbursement restrictions for mental health services during certain
emergency periods. On March 17, 2020, a division of HHS released
guidance allowing patients to be seen via live videoconferencing in
their homes, without having to travel to a qualifying ``originating
site'' for Medicare telehealth encounters. As a result, OSHA expects
that many mental health physicians and other practitioners who might
face economic feasibility issues as a result of the ETS would elect to
provide virtual mental health services that fall outside the scope of
the rule. Furthermore, psychiatrists and other mental health
practitioners practice in a highly regulated industry that is typically
based on state licensure that even restricts practice across state
lines, never mind national borders. As a result, there is little
foreign competition in these industries, indicating that these
practitioners would have the ability to pass the costs of compliance
onto patients (or insurers).
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\82\ OSHA used the findings of the Dingel & Neiman study as the
basis for its estimates of the percentages of employees who are able
to work remotely, as discussed in section VI.B.VIII.e of this
analysis.
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For the above reasons, OSHA finds that the ETS is economically
feasible for establishments in NAICS 621310, NAICS 621112, NAICS 621330
and NAICS 621399.
As shown in Table VI.B.38, establishments in 10 six-digit NAICS
covered by the ETS are estimated to have costs in excess of ten percent
of profits, ranging from a high of 23.82 percent for NAICS 621112
(Offices of Physicians, Mental Health Specialists) to 11.51 percent for
NAICS 621320 (Office of Optometrists): The industries with costs that
exceed ten percent of profits are:
1. NAICS 621112--Offices of Physicians, Mental Health Specialists,
23.82 percent;
2. NAICS 621310--Offices of Chiropractors, 23.21 percent;
3. NAICS 621330--Offices of Mental Health Practitioners (except
Physicians), 17.31 percent;
4. NAICS 621399--Offices of All Other Miscellaneous Health
Practitioners, 16.65 percent;
5. NAICS 621340--Offices of Physical, Occupational and Speech
Therapists and Audiologists, 15.69 percent;
6. NAICS 621391--Office of Podiatrists, 14.81 percent;
7. NAICS 621410--Family Planning Centers, 12.41 percent;
8. NAICS 623210--Residential Intellectual and Developmental
Disability Facilities, 12.07 percent;
9. NAICS 621210--Office of Dentists, 11.71 percent; and
10. NAICS 621320--Office of Optometrists, 11.51 percent.
Several of these NAICS industries are the same as those that failed
the revenue-screening test. As discussed above, those NAICS industries,
and nearly all of the rest of the NAICS industries with cost-to-profit
ratios above 10 percent, are expected to avoid the costs of complying
with the ETS by performing screening for COVID-19 and preventing people
with suspected or confirmed COVID-19 infections from entering their
facility (see paragraph (a)(2)(iii)). This exemption is available to
ambulatory care facilities, which describes nine out of the ten NAICS
industries that were above the profit threshold. As noted earlier, in
those NAICS industries, establishments for which full compliance with
the ETS might cause economic feasibility concerns could avoid the costs
of the standard by adopting procedures to screen non-employees prior to
entry and prevent those with suspected or confirmed COVID-19 from
entering.
The one exception is NAICS 623210--Residential Intellectual and
Developmental Disability Facilities. Because facilities in this NAICS
industries provide residential care, they would not fall under any of
the full scope exemptions in the ETS. However, OSHA notes that this
NAICS industry did not fail the cost-to-revenue screening test, which
OSHA believes is the more useful metric for this industry. There is no
foreign competition, and because all facilities in this NAICS industry
must comply with the ETS and incur similar costs, the availability of
cheaper substitute services will be limited. OSHA also notes that the
ETS includes a partial scope exemption for vaccinated workers in
specific areas that could save the employer compliance costs for
facemasks, distancing, and barriers (see Sec. 1910.502(a)(4)),
particularly to the extent that employers in this NAICS industry do not
normally allow residents with COVID-19 into their facilities.
Finally, OSHA notes that none of the 10 industries that are above
the profit screen are subject to foreign competition. The services
provided by these industries are often necessities and covered in part
or total by insurance, both of which are contributing factors to a very
inelastic demand curve, enabling them to pass the cost of the ETS onto
the patients, as described earlier in this section. Accordingly, the
firms in these 10 industries with ETS costs exceeding 10 percent of
profits would not, in fact, have to absorb the costs in the form of
lost profits, but would be able to increase revenue to recover most or
all of the ETS costs. Thus cost-to-revenues is the proper metric for
these industries. And, as explained above, OSHA does not anticipate
feasibility problems in the four industries with cost-to-revenues
ratios above one percent; the remaining six did not fall above the
revenue threshold.
For these reasons, OSHA finds that the ETS is economically feasible
for all covered industries in their entirety.
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TR21JN21.047
[GRAPHIC] [TIFF OMITTED] TR21JN21.048
BILLING CODE 4510-26-C
a. Economic Feasibility Screening Analysis: Small and Very Small
Businesses
The preceding discussion focused on the economic viability of each
affected industry in its entirety, including entities of all sizes.
Even though OSHA found that the ETS does not threaten the economic
viability of these industries, the agency also examines whether there
is still a possibility that the competitive structure of these
industries could be significantly altered. For instance, if the
increase in costs were such that most or all small firms in that
industry would have to close, it could reasonably be concluded that the
competitive structure of the industry had been affected by the rule. To
address this possibility, OSHA will follow its normal rulemaking
procedure for examining the average compliance costs per affected small
entity and very small entity for each industry covered under the ETS.
As with all establishments, the agency relies on the two screening
tests (costs less than one percent of revenue and costs less than ten
percent of profit) to evaluate the impacts on small and very small
entities.\83\ In cases where the small and very small entities in
particular industries are above the threshold level for either
screening test, OSHA will investigate further.\84\
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\83\ Note that OSHA uses the same screening tests (costs less
than one percent of revenue and costs less than ten percent of
profit) to evaluate the economic feasibility of all of its
standards. These economic feasibility screening tests should not be
confused with OSHA's regulatory flexibility screening tests for
small and very small entities, which are whether costs are less than
one percent of revenue and less than five percent of profit for
these entities. These regulatory flexibility screening tests are
used to determine, under the Regulatory Flexibility Act (5 U.S.C.
601 et seq.), whether the rule will have a significant economic
impact on a substantial number of small entities. See e.g. OSHA
(March 25, 2016), Final Economic and Regulatory Flexibility Analysis
for OSHA's Rule on Occupational Exposure to Respirable Crystalline
Silica, Chapter VI, pp. VI-11 to VI-12. The significant economic
impact test is entirely distinct from the determination of economic
feasibility. Because OSHA has certified that compliance with the
requirements of the Regulatory Flexibility Act are not practicable
under the circumstances, OSHA has not performed the significant
impact screening analysis for the ETS.
\84\ One additional factor that is relevant to OSHA's analysis
of feasibility for this particular rule is the high level of
baseline compliance with the ETS's requirements in comparison to
other new OSHA standards. As explained in section VI.C., OSHA
estimates that about 50 percent of very small entities and 75
percent of small entities are already broadly in compliance with
most provisions of the ETS. This current compliance rate indicates
that many businesses will have very low costs to comply with the new
requirements and that the costs would be borne primarily by those
businesses that have lagged in implementing safety measures. See
Lead I, 647 F.2d at 1130 (`` `It would appear to be consistent with
the purposes of the [OSH] Act to envisage the economic demise of an
employer who has lagged behind the rest of the industry in
protecting the health and safety of employees and is consequently
financially unable to comply with new standards as quickly as other
employers' '') (quoting Indus. Union Dep't, AFL-CIO v. Hodgson, 499
F.2d 467, 478 (D.C. Cir. 1974)). The businesses that have already
incurred many of the costs of compliance, including half of very
small entities and the majority of small entities, will presumably
be at low risk of going out of business as a result of the ETS.
Therefore, even when small or very small entities are above the
screening thresholds for particular industries, it would be very
unlikely that this ETS would meet the criteria for alteration of the
economic structure of affected industries based on the failure of
most or all of the small or very small entities in those industries.
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OSHA notes that cost impacts for affected small or very small
entities will generally tend to be somewhat higher, on average, than
the cost impacts for the average business in those affected industries.
That is to be expected. After all, smaller businesses typically suffer
from diseconomies of scale in many aspects of their business, leading
to lower revenue per dollar of cost and higher average costs. Small
businesses are able to overcome these obstacles by providing
specialized products and services, offering local service and better
service, or otherwise creating a market niche for themselves. The
higher cost impacts for smaller businesses estimated for this rule
generally fall within the range observed in other OSHA standards and
OSHA is not aware of any record of major industry failures resulting
from those standards.\85\
---------------------------------------------------------------------------
\85\ For example, OSHA's economic analysis for the agency's 2016
silica rule showed cost-to-profit ratios as high as 39 percent for
small entities and 91 percent for very small entities (OSHA (March
25, 2016), Final Economic and Regulatory Flexibility Analysis for
OSHA's Rule on Occupational Exposure to Respirable Crystalline
Silica, Chapter VI, p. VI-85).
---------------------------------------------------------------------------
As explained above, OSHA is relying on the threshold of a costs-to-
revenue ratio of one percent as the superior indicator of economic
feasibility unless the industries that ``fail'' the cost-to-profits
screening test are unable to pass the costs onto their customers. For
the industries that have a cost-to-profit ratio above ten percent,
therefore, the discussion focuses on the ability of these industries to
pass along their increased costs, rather than absorbing them in the
form of reduced profits. For industries that are below the thresholds
for both the cost-to-revenue and cost-to-profit ratios, the agency
concludes that the costs of complying with the ETS are unlikely to
threaten the survival of small establishments or very small
establishments and are, consequently, unlikely to alter the competitive
structure of the affected industries.
Table VI.B.39, ``Screening Analysis for SBA-Defined Small
Entities,'' shows that the estimated cost of complying with the ETS for
the average small establishment covered by the standard is $5,438.
Table VI.B.40: Screening Analysis for Very Small Entities (fewer than
20 Employees) shows that the estimated cost of the rule for the average
very small entity is $3,432.
Small entities in five six-digit NAICS industries covered by the
ETS are estimated to have costs in excess of one percent of annual
revenues:
1. NAICS 621310--Offices of Chiropractors, 1.47 percent;
2. NAICS 621399--Offices of All Other Miscellaneous Health
Practitioners, 1.24 percent;
3. NAICS 621340--Offices of Physical, Occupational and Speech
Therapists and Audiologists, 1.23 percent;
4. NAICS 621112--Offices of Physicians, Mental Health Specialists,
1.14 percent;
5. NAICS 621330--Offices of Mental Health Practitioners (except
Physicians), 1.09 percent;
As discussed above in the section on feasibility for all
establishments, these NAICS industries that failed the revenue screen
are all ambulatory care facilities that can be easily scoped out of
compliance with the requirements of the ETS pursuant to paragraph
(a)(2)(iii) and therefore most employers will not need to incur the
costs of complying with the standard. The other reasons noted above for
the same NAICS industries still apply to these categories of small
businesses. Because all five NAICS industries that are above the
revenue threshold for small entities are comprised of ambulatory care
providers, OSHA finds the ETS to be feasible for small entities in
those NAICS industries.
Turning to the cost-to-profit test, small entities in 16 six-digit
NAICS industries covered by the ETS are estimated to have costs in
excess of ten percent of profits, ranging from a high of 23.79 percent
for NAICS 621112 (Offices of Physicians, Mental Health Specialists) to
10.90 percent for NAICS 623312 (Assisted Living Facilities for the
Elderly).
The 16 industries with cost-to-profit ratios above 10 percent for
SBA-defined small entities are:
1. NAICS 621112--Offices of Physicians, Mental Health Specialists,
23.79 percent;
2. NAICS 621310--Office of Chiropractors, 23.39 percent;
3. NAICS 621410--Family Planning Centers, 20.32 percent;
4. NAICS 621399--Offices of All Other Miscellaneous Health
Practitioners, 19.70 percent;
5. NAICS 621340--Offices of Physical, Occupational and Speech
Therapists and Audiologists, 19.57 percent;
6. NAICS 622110--General Medical and Surgical Hospitals, 17.76
percent;
7. NAICS 621330--Offices of Mental Health Practitioners (except
Physicians), 17.30 percent;
8. NAICS 621391--Office of Podiatrists, 15.15 percent;
9. NAICS 561311--Employment Placement Agencies, 15.13 percent;
10. NAICS 621111--Offices of Physicians (except Mental Health
Specialists), 14.49 percent;
11. NAICS 623210--Residential Intellectual and Developmental
Disability Facilities, 12.35 percent;
12. NAICS 621210--Office of Dentists, 12.21 percent;
13. NAICS 621320--Office of Optometrists, 12.06 percent;
14. NAICS 621991--Blood and Organ Banks, 12.02 percent;
15. NAICS 621498--All Other Outpatient Care Centers, 11.60 percent;
16. NAICS 623312--Assisted Living Facilities for the Elderly, 10.90
percent.
Of the sixteen industries that fail the profit screening, all but 5
would be eligible for the ambulatory care exemptions in Sec.
1910.502(a)(2)(iii) (for ambulatory care outside hospital settings) or
(a)(2)(iv) (for ambulatory facilities located within hospital settings
where workers are vaccinated). Some, such as mental health care
providers, may also be able to provide care through telehealth, thereby
avoiding the costs of the ETS (see Sec. 1910.502(a)(vii)).
As discussed in the previous section, all the firms in the 5 NAICS
industries that do not provide ambulatory care must comply with the
ETS, substantially diminishing the ability of a competitor to offer a
substitute product or service at a lower price, as they all are
expected to incur the costs of compliance. These industries also
provide domestic services and are not subject to foreign competition.
This, along with the fact that services provided by these industries
are often necessities and covered in part or total by insurance, are
contributing factors to very inelastic demand curves. The inelasticity
of demand enables practitioners in these industries to pass costs along
to their patients. Accordingly, the small entities in these industries
with ETS costs exceeding 10 percent of profits would not, in fact, have
to absorb the costs in the form of lost profits, but would be able to
increase revenue to recover most or all of the ETS costs. Thus, the
cost-to-revenues screen is the more useful metric for these industries,
and none of those firms fail the revenue screen.
The five industries that do exceed the profit threshold are not
obvious candidates for the ambulatory care exemption or any of the
other blanket exemptions to the scope of the standard, although they
may be able to reduce costs through the vaccinated-employee partial
exemption in Sec. 1910.502(a)(4). Each of these is addressed in turn
below with the explanation of why the ETS would be feasible for the
majority of small entities in these NAICS industries.
NAICS 622110--General Medical and Surgical Hospitals: These
essential services have significant inelastic demand and there are no
substitute services that would not also be subject to the ETS. As
described earlier in this section, these establishments can pass along
costs, or can apply for CARES Act Relief funds to help them weather
financial difficulties during the temporary period in which the ETS
will be in effect.
NAICS 561311--Employment Placement Agencies: Entities in this NAICS
industry are included in the scope of the ETS because they place
healthcare personnel into medical facilities or other locations to
provide healthcare services. However, it seems unlikely that they would
be providing healthcare services inside their placement offices, so the
exception for ``healthcare support services not performed in a
healthcare setting'' would likely apply such that they could avoid the
costs of the rule with respect to their administrative offices (Sec.
1910.502(a)(2)(vi)). To the extent that they have employees who
contract to work in other healthcare settings, they could either pass
along the costs through increases in the contract costs or arrange with
the host healthcare provider to directly assume the costs for providing
PPE, barriers, and other protections needed in the host setting. In the
unlikely event that the ETS costs impacted demand in this area,
employers in this field could decrease the number of employees.
NAICS 623210--Residential Intellectual and Developmental Disability
Facilities: It is feasible for the employers in this NAICS industry to
comply with the ETS for the reasons already provided earlier with
respect to the same NAICS industry failing the profit screen for the
all-sized category, as well as the other general reasons identifies in
this section.
NAICS 621991--Blood and Organ Banks: The ETS would be economically
feasible for small businesses in this NAICS industry because blood and
organs are textbook examples of essential goods and services for which
there is such a constant demand that firms in this NAICS industry can
easily pass along costs to the hospitals and other clients who need to
obtain blood or organs.
NAICS 623312--Assisted Living Facilities for the Elderly: This
NAICS industry, which only slightly exceeds the profit-to-cost screen
of 10 percent at 10.9 percent, is not subject to substitution because
there is typically significant demand for these services and all
similar facilities would be covered by the ETS.
For these reasons, the increase in costs are not such that most or
all small firms in those NAICS industries would have to close, and OSHA
concludes that the competitive structure of these industries will not
be affected by the rule. OSHA therefore finds that the ETS is
economically feasible for small entities in these industries.
As shown in Table VI.B.40, very small entities in 10 six-digit
NAICS industries covered by the ETS are estimated to have costs in
excess of one percent of revenues, ranging from a high of 1.63 percent
for NAICS 621330 (Offices of Mental Health Practitioners (except
Physicians)) to 1.02 percent for NAICS 621910 (Ambulance Services):
1. NAICS 621330--Offices of Mental Health Practitioners (except
Physicians), 1.63 percent;
2. NAICS 621399--Offices of All Other Miscellaneous Health
Practitioners, 1.56 percent;
3. NAICS 621310--Office of Chiropractors, 1.54 percent;
4. NAICS 621340--Offices of Physical, Occupational and Speech
Therapists and Audiologists, 1.49 percent;
5. NAICS 621410--Family Planning Centers, 1.41 percent;
6. NAICS 621112--Offices of Physicians, Mental Health Specialists,
1.37 percent;
7. NAICS 621610--Home Health Care Services, 1.13 percent;
8. NAICS 621391--Office of Podiatrists, 1.08 percent;
9. NAICS 922160--Public Firefighter-EMTs, 1.03 percent;
10. NAICS 621910--Ambulance Services, 1.02 percent;
Most employers in all but three of those NAICS industries are
likely eligible for the non-hospital ambulatory care exception in Sec.
1910.502(a)(2)(iii) if they screen out and bar entry to people with
suspected or confirmed COVID-19. That basis alone is sufficient to
support a finding that the ETS will not disrupt any of those
industries. In addition, OSHA notes that all of the very small
businesses in this group that failed the
revenue screen provide services that do not face foreign competition
and cannot be readily substituted by other domestic healthcare
providers because those providers would also be subject to the ETS and
incur the same costs.
There are three groups that are not likely to qualify for the
ambulatory care scope exception. All three have inelastic demand for
their services and no obvious substitutes, so they could easily pass
along costs.
NAICS 621610--Home Health Care Services,
NAICS 922160--Public Firefighter-EMTs,
NAICS 621910--Ambulance Services,
The ETS includes provides a scope exception in Sec.
1910.502(a)(2)(v) for home health care when the employees conducting a
home visit are fully vaccinated and screen their patients and limit
their services to homes where there is no one with suspected or
confirmed to have COVID-19. Public Firefighters-EMTs and Ambulance
Services are both essential services that typically receive enough
support from public funding that it would be very unlikely that any
such employer would be driven out of business by an increase in cost,
and even more unlikely that the industry would be disrupted by the ETS
costs. Both the firefighter/EMTs and ambulance services barely failed
the screen at 1.02 and 1.03, respectively, even when costs were
compared to just 6 months of revenue.
Very small entities in 26 six digit NAICS industries that are
covered by the ETS are estimated to have costs in excess of ten percent
of profits, ranging from 34.14 percent for NAICS 561311 (Employment
Placement Agencies) to 10.02 percent for NAICS 621991 (Blood and Organ
Banks). The 26 very small entities with cost-to-profit ratios above 10
percent are:
1. NAICS 561311--Employment Placement Agencies, 34.14 percent;
2. NAICS 621410--Family Planning Centers, 32.17 percent;
3. NAICS 621112--Offices of Physicians, Mental Health Specialists,
28.69 percent;
4. NAICS 621330--Offices of Mental Health Practitioners (except
Physicians), 25.90 percent;
5. NAICS 621399--Offices of All Other Miscellaneous Health
Practitioners, 24.77 percent;
6. NAICS 621310--Offices of Chiropractors, 24.45 percent;
7. NAICS 621340--Offices of Physical, Occupational and Speech
Therapists and Audiologists, 23.69 percent;
8. NAICS 621420--Outpatient Mental Health and Substance Abuse
Centers, 20.46 percent;
9. NAICS 621610--Home Health Care Services, 19.93 percent;
10. NAICS 922160--Public Firefighters-EMTs, 18.23 percent;
11. NAICS 621111--Offices of Physicians (except Mental Health
Specialists), 17.97 percent;
12. NAICS 621910--Ambulance Services, 17.93 percent;
13. NAICS 621498--All Other Outpatient Care Centers, 17.49 percent;
14. NAICS 621391--Offices of Podiatrists, 17.10 percent;
15. NAICS 623312--Assisted Living Facilities for the Elderly, 16.59
percent;
16. NAICS 623210--Residential Intellectual and Developmental
Disability Facilities, 16.04 percent;
17. NAICS 621320--Offices of Optometrists, 13.74 percent;
18. NAICS 621210--Offices of Dentists, 13.48 percent;
19. NAICS 621492--Kidney Dialysis Centers, 13.31 percent;
20. NAICS 621999--All Other Miscellaneous Ambulatory Health Care
Services, 12.65 percent;
21. NAICS 623311--Continuing Care Retirement Communities, 12.62
percent;
22. NAICS 611710--Educational Support Services, 11.95 percent;
23. NAICS 623990--Other Residential Care Facilities, 11.67 percent;
24. NAICS 611110--Elementary and Secondary Schools, 11.63 percent;
25. NAICS 561210--Facility Support Services, 10.48 percent; and
26. NAICS 621991--Blood and Organ Banks, 10.02 percent.
The feasibility of the ETS has been addressed earlier for employers
in most of these NAICS industries, while a number of the employers not
previously addressed would be eligible for the ambulatory care
exception in Sec. 1910.502(a)(2)(iii) (Outpatient Care, Outpatient
Mental Health and Substance Abuse Centers, Physicians' Offices, Kidney
Dialysis Centers, Miscellaneous Ambulatory Care). As with the small
entities, these industries provide domestic services and are not
subject to international competition. As a result, these industries
would have the ability to pass costs onto the customer. Accordingly,
the very small entities in these industries with ETS costs exceeding 10
percent of profits would not, in fact, have to absorb the costs in the
form of lost profits, but would be able to increase revenue to recover
most or all of the ETS costs.
There do not appear to be any feasibility issues for any of the
remaining very small entities that failed the profit screen for the
reasons below:
NAICS 623311--Continuing Care Retirement Communities: As with
assisted living, these are not subject to substitution because there is
typically significant demand for these services and all similar
facilities would be covered by the ETS.
NAICS 623990--Other Residential Care Facilities: Same as continuing
care retirement communities.
NAICS 611710--Educational Support Services: Employers in this NAICS
are likely small firms who provide school nursing services to public
and private schools. OSHA believes that the demand for such services is
inelastic, and such entities will be able to pass the roughly $2,000 in
one-time costs to their clients.
NAICS 611110--Elementary and Secondary Schools: Employers who are
very small entities within this NAICS industry and failed the profit
screen are likely to be private educational institutions with a school
nurse or similar personnel. However, the NAICS industries includes a
variety of educational institutions, including for profit, non-profit,
and public. Public schools have the ability to pass compliance costs on
to their local funding jurisdictions, while some private schools have
affiliated religious or other institutions that can provide financial
support to these institutions without it counting toward ``profit.'' In
addition, the federal government has distributed significant funding to
schools for the purposes of assisting the schools in protecting against
COVID-19, so many schools will be able to use that money to protect
their healthcare workers in accordance with the ETS. Even in the
unlikely event that a small number of institutions would not be able to
sustain the one-time $2,000 cost of the ETS, the likely result could be
the temporary closure of a school nurse's office, if permitted by law,
as opposed to closure of an entire school. Even in the unlikely event
that a small number of institutions would not be able to sustain the
one-time $2,000 cost of the ETS, OSHA finds it very unlikely that the
failure of such schools for that reason would disrupt the education
sector when many private education institutions are non-profit
organizations.
NAICS 561210--Facility Support Services: Employers providing
services tied to specific facilities will typically be essential to
that facility, especially when any potential source of substitution
would also be subject to the same ETS costs.
For the reasons identified above the increase in costs are not such
that most or all very small firms in that industry would have to close,
the competitive
structure of these industries will not be affected by the rule. OSHA
therefore concludes that compliance with the ETS would be economically
feasible for very small entities in these covered industries.
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TR21JN21.049
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[GRAPHIC] [TIFF OMITTED] TR21JN21.051
[GRAPHIC] [TIFF OMITTED] TR21JN21.052
BILLING CODE 4510-26-C
b. Conclusion
To determine whether compliance with the ETS is economically
feasible for all affected industries, OSHA conducted two screening
tests to determine whether the costs of the rule are beneath the
threshold level at which the economic viability of an affected industry
might be threatened. The two screening tests are the one-percent-of-
revenue test and the ten-percent-of-profit test. For those industries
with costs beneath both of these threshold levels, the rule was
presumed to be economically feasible. Industries that have costs
beneath both thresholds for all establishments constitute the majority
of industries covered by the ETS. For industries with costs above one
percent of revenues or ten percent of profits, OSHA performed
additional analysis regarding whether firms would
be eligible for scope exemptions to avoid the cost of compliance with
the ETS or whether they could generally pass on the compliance costs of
the rule in the form of higher prices or if, instead, firms would have
to absorb the costs of the rule in the form of lost profits. Given the
fact that all competitors in the industries that had costs above the
revenue or profit threshold have to comply with the ETS, OSHA does not
expect foreign competition or other factors to restrict the ability of
affected firms to pass the costs of the ETS on to consumers through
price increases.
OSHA has, for that reason and for the additional reasons described
in more detail above, concluded that the revenue test is the most
appropriate metric to use for determining the economic feasibility of
the ETS. Looking at ETS costs to revenues, OSHA has concluded that
complying with the ETS is economically feasible for all covered
industries in their entirety. Furthermore, none of the economic impacts
on small or very small entities are such as to threaten the structure
of any of the covered healthcare industries (this is further buttressed
by the significant baseline compliance of the small and very small
entities in these industries).
In addition, it is important to note that the costs of compliance
with the ETS will only affect revenues and profits for the period
during which the ETS is in effect, which is expected to be at most 6
months, so it will be easier for employers to withstand the impact of
any additional costs for this time period as opposed to absorbing
ongoing costs typically required by rulemakings.
Finally, OSHA notes that most of the NAICS that failed one or both
of the screens would not have done so if OSHA followed its normal
analysis of comparing costs to annual profit and revenue, as opposed to
only 6 months of profits and revenue. Under a one-year timeframe of
revenues and costs, the economic impacts of the ETS would have been cut
in half.
VIII. COVID-19 ETS Health Benefits
a. Introduction
This chapter estimates the health benefits of the COVID-19
Emergency Temporary Standard (ETS), while the following chapter
discusses other (non-health) benefits of the ETS. Assessing the health
benefits of the ETS accurately is a difficult task because COVID-19
case and fatality counts change rapidly and because the recent
deployment of three new vaccines and the advance of rapidly spreading
variants have complicated the calculation of baseline infections and
deaths for the ETS. As vaccines have become available to an increasing
number of people, fatalities from COVID-19 have dropped over the last
few months. Meanwhile, case counts and hospitalizations have not
uniformly decreased alongside vaccinations, instead at times
increasing--including among people of working age--as a particularly
transmissible variant accounts for more than a quarter of new cases
assessed in the U.S. To be representative of recent experience, OSHA is
examining the number of cases and fatalities during the recent month of
March 20, 2021 through April 20, 2021, to develop an estimate of how
many infections and fatalities will be prevented over the 6-month
period of the ETS if those numbers stay constant during that time. OSHA
labels this its ``primary'' estimate. But there is a great deal of
uncertainty around any estimates of health benefits obtained from the
ETS. OSHA also developed a scenario that uses the historic average over
the first year of the pandemic, divided by two, as an alternative
estimate of impacts for the next six months. There are further
discussions of the effects of vaccines below, as a part of a systematic
construction of possible cases and fatalities avoided.
The estimation of the monetized health benefits of the ETS, taking
into account community transmission (transmission outside the
workplace) and the degree of worker vaccination, as well as other
uncertainties, is developed step by step in the following sections. The
first section describes the scope and limitation of ETS health
benefits. The second section describes the data and underlying
assumptions used in OSHA's estimation of health benefits for workers in
healthcare (HCWs) subject to 29 CFR 1910.502. The third section
addresses how OSHA developed several baseline estimates of infections
and deaths from the SARS-CoV-2 virus for HCWs that might occur in the
absence of the ETS and vaccination. The fourth section describes how
OSHA estimated the infections and deaths that would be prevented by the
ETS relative to (alternative) baseline conditions. In that section,
OSHA takes into account the rapid development and deployment of
vaccines for the working population. The health benefits of infections
and deaths averted due to the ETS are monetized in the fifth section.
The chapter concludes with a summary of estimated health benefits of
the ETS under various scenarios.
b. Scope of OSHA's Estimates of ETS Health Benefits and Discussion of
Secondary Benefits
For the purpose of estimating the ETS benefits, OSHA has not
attempted to quantify or account for a variety of secondary and
feedback health benefits arising as a result of the ETS. For example,
the agency does not account for the secondary benefits of avoided
COVID-19 cases among family and friends (other than co-workers) that
would occur due to exposure to an infected worker absent the ETS. The
agency also does not count the benefits of avoided cases that would
otherwise occur due to workplace transmission from employees to
patients and other visitors to a healthcare facility. Nor does the
agency include the many downstream benefits to the public of keeping
HCWs safe from COVID-19, including maintaining sufficient healthy staff
with the necessary skills to treat patients in need of care. Other
unquantified benefits include those due to the feedback effects of
reduced community spread of the virus that may lead to fewer COVID-19
infections and deaths generally, including reduced spread to workers
outside the workplace. As discussed below in the following two
paragraphs, the agency believes that taken together these non-
quantified benefits are sizable.
Reducing cases of COVID-19 among HCWs will help ensure the
effective functioning of the healthcare system, which in turn protects
workers who become patients, as well as many others, after COVID-19
infection. Patients hospitalized for COVID-19 require substantial
health care resources such as staff, beds, and equipment. Many
hospitals over the course of the pandemic have been at or near ICU
capacity due to the surges in COVID-19 cases, diminishing the health
care system's ability to provide essential healthcare services.
Reducing employee infections can remove one of the stressors on the
healthcare system. Reducing infections among HCWs in particular will
increase the number of staff available to treat patients with both
COVID-19 and non-COVID-19 ailments. In turn, the quality of care will
improve since medical staff will be less time constrained.
Additionally, the estimated quantified ETS benefits do not include
non-health related benefits such as a beneficial impact on the economy
at large or the impact of how the disease has disproportionately
impacted communities of color both financially and in terms of health
effects and lives lost throughout the pandemic. For a
discussion of non-health related benefits please see the section
VI.B.VIII.i, Other (Non-Health) Benefits of the ETS.
c. Limitations of OSHA's Estimates of ETS Health Benefits
OSHA's analysis of potential benefits has a number of analytical
limitations due to the uncertain trajectory of the pandemic, difficulty
forecasting future infection and death rates, difficulty quantifying
the impacts of various factors that might influence this analysis,
unavailability of data and information suitable for extrapolation, and
limits on the time and resources available for this analysis given the
emergency circumstances.
Throughout the analysis, OSHA found it necessary to include a
variety of simplifying assumptions. Some of the most important are
summarized here and discussed further later in the analysis:
The ETS will be in place for six months.
HCWs are age 18-64.
HCWs have the same COVID-19 infection rates as non-health
care workers (NHCWs).\86\
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\86\ OSHA emphasizes that this is a simplifying assumption for
the analysis. OSHA believes that HCW, on average, face higher risks
of COVID-19 illness than most NHCW.
---------------------------------------------------------------------------
Each of the next 6 months of infections and deaths will
duplicate the ``primary'' scenario or the monthly ``alternative''
scenario average.
The average vaccination rate over the next six months for
the HCW population will be 75 percent. Vaccines will have an 85.2
percent efficacy rate at preventing infections and will prevent all
fatalities (U.S. Food and Drug Administration (FDA), December 18, 2020,
U.S. Food and Drug Administration (FDA), December 11, 2020, U.S. Food
and Drug Administration (FDA), February 4, 2021).
80 percent of COVID-19 infections and deaths in HCWs are
workplace-acquired; the remaining 20 percent are attributable to
community spread.
The standard will have preventiveness coefficients of 94
percent of HCW workplace transmissions and, taking into account a
community spread of 20 percent, an overall effectiveness rate of 75
percent for HCWs.
These simplifying assumptions mean that specific analytical inputs
and outputs might be over- or underestimated to the extent that real
world conditions vary from these assumptions. As discussed further, a
sensitivity analysis was conducted exploring some alternative
simplifying assumptions, along with examples with much lower monthly
case counts. This analysis is presented at the end of this document.
OSHA was also not able to adjust its quantitative estimates to
account for several factors that might impact the potential benefits of
the ETS. These include:
Unreported infections or deaths. Infections and deaths may
have been underreported early in the pandemic, when knowledge of, and
testing for, COVID-19 were more limited.
Potential reductions in fatalities from improvements in
medical treatment for COVID-19 in the coming months.
Impacts of mutations or variations in the SARS-CoV-2 virus
on disease transmissibility or severity, virus susceptibility to one or
more class of therapies, and neutralization of antibodies generated
during previous infection or vaccination.
Changes in social and state, local, tribal, and
territorial government practices and restrictions beyond those
reflected in the baseline infection and death counts. These changes
could result in more or fewer vulnerable workers being exposed to
COVID-19.
Decreases in teleworking and more in-person work, which
would increase the benefits for this ETS.
Chronic impacts of COVID-19 disease, including any
potential risk of premature death.
While OSHA relied on the best available evidence in forming its
estimates, it is possible that given these analytical limitations,
aspects of OSHA's quantitative estimate of benefits may be over or
underestimated. Additionally, a variety of potential benefits were not
quantified.
OSHA requests public comments on relevant data, literature, and
methodological suggestions that it might use to improve underlying
assumptions or otherwise address these limitations at the final
standard rule stage, if a final standard is needed. OSHA also welcomes
comments on all aspects of the economic analysis.
d. Data and Estimation Methods
The starting point for estimating the expected number of COVID-19
infections and deaths prevented by the ETS is to estimate the expected
number of the respective health outcomes in the absence of the ETS. The
data source for the baseline estimates is from the Centers for Disease
Control and Prevention (CDC): The CDC's Cases and Deaths, Daily and
Total Trends, found on the CDC Daily Tracker website (CDC April 20,
2021). The CDC collects COVID-19 data from state and county health
departments and publishes a daily update that includes the number of
confirmed infections in the U.S. along with cumulative deaths. The CDC
reports both the total number of ``confirmed'' COVID-19 infections
(i.e., confirmed by a lab test such as a polymerase chain reaction or
serologic test) and ``probable'' cases (i.e., clinical and
epidemiologic evidence without confirmed testing).\87\ Note that the
CDC daily reports likely undercount the number of infections since most
people infected with COVID-19 are not tested.\88\ The characteristics
of the CDC data that OSHA uses to calculate the baseline estimates for
the healthcare worker populations are described below.
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\87\ CDC's (2021a) website notes the following:
A confirmed case or death is defined by meeting confirmatory
laboratory evidence for COVID-19.
A probable case or death is defined by one of the following:
Meeting clinical criteria AND epidemiologic evidence with no
confirmatory laboratory testing performed for COVID-19.
Meeting presumptive laboratory evidence AND either clinical
criteria OR epidemiologic evidence.
Meeting vital records criteria with no confirmatory laboratory
testing performed for COVID19.
Source: CDC, March 23, 2021.
\88\ The Estimated Disease Burden of COVID-19 shows that only
one out of every 4.6 COVID-19 cases in the U.S. was reported from
February 2020 to December 2020 (CDC, April 29, 2021).
---------------------------------------------------------------------------
Forecasts of COVID-19 cases and deaths involve a high level of
uncertainty, because they depend largely on predicting human behavior,
both inside and outside of work; mitigation policies at all levels of
government, which are constantly changing; and the emergence of new
variants of the virus, all of which are major factors influencing COVID
outcomes. Forecasting the course of the pandemic beyond four weeks is
so uncertain that many infectious disease modelers refuse to do it. For
example, one recent review found that, compared to one-week forecasts,
prediction errors doubled when forecasting four weeks out and were five
to six times higher when forecasting 20 weeks out (Cramer et al.,
February 5, 2021). The same review found that, on average, models
looking eight weeks or more ahead estimated ranges that included the
actual outcome less than half the time. Given that degree of
uncertainty, the CDC only forecasts for four weeks and does so as an
ensemble model, which brings together insights from numerous different
models into a combined forecast (CDC, April 20, 2021).
Short-range predictions from models such as the CDC Ensemble Model
have provided useful information. For example, on March 15, 2021 the
CDC Ensemble Model for the week ending April 10, 2021 showed a mid-
point estimate of 272,367 cases. That week there were 451,328 cases,
but this was well within the forecast range of 137,538 to 510,617 cases
per week. On April 25, 2021, this group of models predicted 248,663 to
723,900 (mid-point of 476,970) new cases per week likely to be reported
in the week ending May 15, 2021; the actual number of reported cases
for the week ending May 15 was 218,241. This was below even the models'
97.5 percent lower bound estimate from April.
Rather than using available forecasting models,\89\ OSHA will rely
on the documented number of cases and deaths during either a recent
time period or for the first year of the pandemic as representing a
range of possible baseline estimates. A review of forecasting models
available to the public over the past year shows they have been
universally inaccurate. OSHA has found none are sufficiently reliable
to support an estimate of COVID-19 cases and deaths for the next 6
months. OSHA's estimates of health benefits from the ETS are therefore
derived from its analysis of the cases in this range, with subsequent
adjustments as described below. OSHA believes this approach is
appropriate as a starting point for this analysis, and notes that the
agency's estimates appear in line with the three-week modeling,
although the CDC Ensemble Model produces a range of estimates with a
midpoint (476,970 cases per week) that is near OSHA's estimate of
510,307 cases per week, based on the month before April 20, 2021 (CDC,
April 20, 2021).
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\89\ Since May, 2020 OSHA staff have monitored the UCLA Model
Comparison page (Statistical Machine Learning Lab at UCLA, 2021))
along with models by the University of Texas, Columbia University,
MIT, Iowa State University, IHME, Los Alamos National Lab, and the
YYG model. Of note, the Model Comparison page stopped ranking
forecasts in the summer of 2020.
---------------------------------------------------------------------------
Summary of COVID-19 Cases and Fatalities Prevented by the ETS
Using OSHA's ``primary'' scenario based on actual data from March
19, 2021 through April 19, 2021 (explained below), and taking into
account overall effectiveness of 75 percent, the agency estimates there
would be 295,284 HCW infections and 776 HCW deaths prevented by the
ETS.\90\ These results are summarized in Table VI.B.41.
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\90\ OSHA's analytical framework is based on raw case data.
Although that does not allow a breakdown by type of healthcare
setting, for the reasons identified in Grave Danger (Section IV.A.
of this preamble), the agency expects that a substantial majority of
the cases among healthcare workers will occur in healthcare settings
where COVID-19 patients are treated or persons who are suspected or
confirmed to have COVID-19 will otherwise be located (e.g.,
healthcare establishments offering COVID-19 testing).
[GRAPHIC] [TIFF OMITTED] TR21JN21.053
Most of this section explains OSHA's use of data to discover the
number of cases and fatalities that would occur over six months without
the ETS. OSHA's step-by-step derivation of baseline infections and
deaths over a six-month period is described in the sections below.
Identification of Total COVID-19 Cases by Age Group To Determine
Infected Worker Population
OSHA bases its analysis of the health benefits on the estimated
reduction in the number of COVID-19 infections and deaths among covered
HCWs as a result of compliance with the ETS. Prevented cases of COVID-
19 infections can range widely in severity and include asymptomatic
cases, cases involving mild to moderate symptoms, cases involving
severe symptoms prompting hospitalization, cases with long-term health
effects, including disability, and fatal cases. For other rulemakings,
OSHA has calculated benefits for the reduced risk of premature death
from chronic disease.\91\ For this ETS, given that the COVID-19
pandemic is a little over a year old, the agency believes that
estimates of the costs of premature death due to the disease's chronic
effects would be too speculative to quantify.
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\91\ See for example, the FEA in support of the January 9, 2017
final beryllium rule [(OSHA 2016a), Pages VII-14 to VII-17].
---------------------------------------------------------------------------
OSHA relies on CDC data reported on April 19, 2021, which was as
current as the timeline for this emergency rulemaking allows, to
identify the data sample for baseline estimates of HCWs COVID-19
infections and deaths. HCWs, for purposes of this section of the
preamble, are those covered by Section 1910.502 of the ETS. As of April
19, 2021, the U.S. had 31,484,148 reported COVID-19 infections and
564,292 deaths. Out of the 31,484,148 COVID-19 infections, 24,726,290
individual ``Human Infection with 2019 Novel Coronavirus Case Report
Forms,'' containing more extensive information about each patient, have
been collected
by the CDC.\92\ Of those forms collected, 24,740,863 indicated the age
of the individual who had COVID-19. Based on those forms, 74 percent of
the people who identified their age were of working age (assumed to be
ages 18 to 64 for purposes of this analysis).
---------------------------------------------------------------------------
\92\ The CDC PUI (Person under Investigation) Form lists the
clinical outcome, which can include death (CDC, May 1, 2020).
---------------------------------------------------------------------------
Table VI.B.42, below, presents the total number of cases and deaths
reported by the CDC through April 19, 2021, along with the agency's
estimate of cases and deaths among employed workers ages 18-64. As its
starting point, OSHA used the number of cases reported by the CDC on
April 19, 2021 (31,484,148). From there, OSHA used the 74 percent
figure described in Table VI.B.42 to exclude all cases among people
ages 1-17 years and 65 years and over to obtain the total number of
cases among people ages 18 to 64.\93\ Once OSHA had estimated the
number of cases within the 18-64 age range, the agency applied an
average employment-to-population ratio of 69 percent to the number of
cases among people ages 18-64 to determine the number of employed
people infected.\94\ OSHA's estimate of the number of cases among
employed adults, ages 18-64, is based on the simplifying assumption
that employed and unemployed adults within this broad age range
contract COVID-19 at the same rate. Teleworkers are removed from this
analysis. Although workers who do not telework may actually have a much
higher infection rate than either teleworkers or unemployed individuals
because of increased contact with others at work, this assumption is
necessary because of the lack of specific data on differences in
infection rates between employed and unemployed individuals. OSHA
followed the same procedure to obtain the number of fatalities among
workers aged 18 to 64. The information in Table VI.B.42 was used to
help develop the baseline estimates that follow.
---------------------------------------------------------------------------
\93\ Workers over age 64 are excluded from the analysis because
including higher age cohorts would introduce the possibility of
overestimating the share of COVID infections and deaths among
workers. In these older cohorts, the employment to population ratio
falls rapidly with age, while fatalities related to COVID-19
increase rapidly with age. For example, within the cohort of those
aged 65-74 years, employment is loaded toward the youngest in the
age group (i.e., people who are 65-67 years old), while many more
fatalities occurred at the higher end of that band (i.e., those 73-
74 years old).
\94\ The average employment to population ratio rate of 69%
among people ages 18-64 is based on the 2020 waves of the Basic
Monthly Current Population Survey (CPS). CPS is a monthly U.S.
survey conducted by the U.S. Census Bureau that is commonly used to
identify the demographic and employment characteristics of
individuals in a household (BLS, 2020).
[GRAPHIC] [TIFF OMITTED] TR21JN21.054
In order to estimate benefits arising from the ETS, OSHA provides
``primary'' and ``alternative'' historic estimates of the number of
cases and fatalities based on two different methods of counting cases
and fatalities. These primary and alternative estimates provide a
bounded range for benefits calculations. The primary historic estimate
corresponds to the number of infections and fatalities in the U.S. (not
just workers) among people ages 18 to 64 in a one-month period (March
19-April 19, 2021). OSHA relies on this estimate in its primary
analysis for several reasons: (1) It has a basis in recent historic
fact, (2) the estimate is well within the bounds of short-term CDC
forecasts, and (3) at the time this analysis was conducted, this is a
reasonable estimate considering the current infection numbers and the
uncertainty between the rate of vaccinations and the spread of more
transmissible variants. If the entire epidemic had behaved similarly to
the primary month levels of infections and fatalities, there would have
been a lower number of infections and fatalities over the past year.
The alternative estimate is based on the historic average monthly
infections and fatalities between April 1, 2020 and April 1, 2021,
which covers most of the pandemic.\95\ To obtain this alternative
estimate, OSHA took the total infections and fatalities for this period
among those who were 18 to 64 years old, and then divided by 12 months.
---------------------------------------------------------------------------
\95\ Prior to April 1, 2020 there had been 188,192 cases
reported, and 4,584 fatalities, beginning in January, 2020.
---------------------------------------------------------------------------
OSHA considered using a higher estimate based on the pre-vaccine
December 2020 surge in cases and fatalities but will instead report the
12-month monthly-average as the alternative estimate. A December
estimate of cases and deaths would be at least twice the magnitude of
even the OSHA alternative estimate (the higher of OSHA's two estimates)
and could significantly over-estimate the benefits even after
vaccinations are considered. Furthermore, at the time this analysis was
conducted, a December weekly case count (of over 1 million) seemed
unreasonable and was also significantly higher than the highest
estimate from the CDC Ensemble model. The primary and alternative
historical averages for infections and fatalities for the U.S.
population ages 18 to 64 are summarized in Table VI.B.43.
[GRAPHIC] [TIFF OMITTED] TR21JN21.055
Baseline Estimate Assumptions
For this analysis, OSHA assumes that the ETS will be in effect for
six months. Estimating baseline COVID-19 infections and deaths that
will occur among HCWs over this six-month period is uncertain due to
several factors, including: (1) The novel nature of the virus and
resulting pandemic; (2) heterogeneous timing and conditions of exposure
control policies enacted by various governmental authorities; (3) new
virus variants; and (4) the effect of currently-authorized vaccines.
OSHA was unable to adjust infection or fatality rates for any of these
factors except vaccination, which is discussed further below. OSHA also
includes a simplifying assumption that NHCWs and HCWs have the same
COVID-19 infection rates. OSHA believes this method significantly
undercounts HCW cases. However, in the benefits calculations, OSHA
takes into account the higher vaccination rates for HCWs. This results
in the ETS providing a lower percentage of infections avoided per HCW
relative to per NHCW.
In developing its main set of baseline estimates, OSHA makes an
important simplifying assumption. For the alternative historic
estimates, OSHA assumes that the average monthly number of HCW
infections and fatalities over the next 6 months will, absent this ETS,
equal the average monthly number of HCW infections and fatalities
during the first twelve months of the epidemic, with April 1, 2020 as
the starting point. In other words, OSHA assumes that the average
monthly number of HCW infections and deaths that occurred during the
twelve-month period from April 2020 to April 2021 will also occur on a
monthly basis during the six-month period beginning when the ETS goes
into effect. The same assumption is also true for the primary scenario.
For the primary scenario, absent the ETS, OSHA assumes that the same
monthly number of cases and fatalities that occurred from March 19,
2021 through April 19, 2021 would be prevented each month, on average,
for the next six months. This simplifying assumption of a constant
continuing average number of baseline infections and deaths makes sense
because, among other reasons, one would not expect employers to
institute additional infection control procedures beyond what they
already have in place absent the requirements of the ETS. As a starting
point for creating the baseline, this assumes other influences--
including social and government practices and restrictions; infection
and fatality rates; variants of the virus; and the efficacy,
production, and use of available vaccines--will stay relatively
constant, or, more realistically, will balance each other out.
e. Baseline Estimates of Cases and Deaths
Table VI.B.44 and Table VI.B.45 and the discussion below illustrate
OSHA's process for determining the number of baseline cases and deaths
that can be affected by the ETS.
[GRAPHIC] [TIFF OMITTED] TR21JN21.056
[GRAPHIC] [TIFF OMITTED] TR21JN21.057
OSHA's process for identifying the number of workplace cases of
COVID-19, which for this analysis is treated the same as the number of
infections,\96\ is illustrated in Table VI.B.44.
---------------------------------------------------------------------------
\96\ OSHA recognizes that not all COVID-19 infections are
identified as COVID-19 cases and that there are important
distinctions in those terms, but for the purposes of this benefits
analysis they are equated for simplicity.
---------------------------------------------------------------------------
The primary scenario OSHA is examining extrapolates data from
March-April 2021. While OSHA has data from the CDC indicating the total
number of COVID-19 cases recorded during March 19-April 19 (2,041,229),
those data do not specify which of those cases are infected workers and
which are other members of the community. The data do, however,
identify most of the cases by age. After OSHA has adjusted the number
of these cases for age (to focus on cases of working-age people--see
Table VI.B.42 and Row B of Table VI.B.44), OSHA also reduces that
number to account for working-age persons who are not employed based on
age-specific employment percentages, assuming the employed and non-
employed have an equal chance of becoming infected. The remaining total
number of worker cases from CDC data for this month is estimated to be
1,047,145 (see Row C of Table VI.B.44).
OSHA's benefits calculations include several additional
adjustments, each described in more detail later, to ensure that they
are focused on the prevention of just those infection transmissions
that would have occurred at the workplace. First, OSHA allocated all
infection cases between teleworking employees (by definition they are
not at the workplace so cannot be infected at work) and physical
workplace employees. Second, OSHA adjusted the number of cases
remaining for physical workplace employees by removing some of those
cases as potentially attributable to community spread (infection
transmission occurring outside the workplace) versus workplace
infection. Any infection discovered at work could have been contracted
at work, at home, or elsewhere outside of the workplace. The ETS does
not protect employees when they are away from the workplace, and they
might still become infected in non-work settings. Failure to account
for these non-work-acquired infections would lead to an overestimation
of the number of cases averted by the ETS. Unfortunately, the data
available to the agency for estimating baseline COVID-19 infections and
deaths do not distinguish between workplace infections and those
acquired elsewhere. To make such a distinction, OSHA ultimately must
try to account for the community spread of infections.
Finally, it is important to note that while OSHA is attempting to
remove community spread cases from benefits calculations, many such
community spread cases include workers in the workplace, so OSHA still
takes full ETS costs for them. For example, the employer would still be
required to pay for the medical removal of an employee who was infected
outside the workplace in order to keep that employee from transmitting
the virus to others at the workplace.
As a final step, OSHA removed a number of cases to account for
vaccinations (later in the analysis the vaccinations are also factored
into reducing monetized benefits).
COVID-19 Cases Among Teleworkers
Table VI.B.46 presents percentages of the labor force by
teleworking and non-teleworking sectors. Note that teleworkers are
estimated from all those occupations capable of telework as estimated
by Dingel and Neiman (July 9, 2020) and will be overestimated to the
extent that, as pandemic conditions improve, more workers return to the
physical workplace.\97\
---------------------------------------------------------------------------
\97\ Dingel & Neiman estimate, by detailed occupation, the
proportion of employees who are capable of full-time telework based
on survey data from the Occupational Information Network (O*Net), a
DOL-sponsored program. Dingel & Neiman use the responses to two
surveys included in release 24.2 of the database administered by
O*NET, the Worker Context Questionnaire and the Generalized Work
Activities Questionnaire. The questions are about standard tasks in
an occupation (use of computer, work outdoors, etc.) The median
occupation had 26 respondents for each work context question and 25
respondents for each generalized work activities question per
detailed-level SOC occupation code. See the paper for full details.
---------------------------------------------------------------------------
[GRAPHIC] [TIFF OMITTED] TR21JN21.058
To use these worker percentages to allocate total cases among the
groups we need to know the relative rate of infections for teleworkers
versus employed non-teleworkers. Here OSHA relies on a study conducted
in mid-2020 that found a relative rate of 66 percent.\98\ Applying this
relative rate, along with the teleworking percentage of 33 percent, to
the total number of worker cases, OSHA calculates that the total number
of COVID-19 cases among teleworkers is 228,797 (33% x 66% x 1,047,145)
(See Table IV.B.44, Row D).\99\
---------------------------------------------------------------------------
\98\ See (Fisher et al., November 6, 2020). They find that 35%
of teleworkers and partial teleworkers were COVID positive versus
53% of employees who worked at a physical workplace, giving a
relative rate of 0.35/.53 = 66%.
\99\ This estimate of teleworker infections has various
uncertainties including the relative rate estimate from this Fisher
et al., (November 6, 2020) study. The final number of participants
of the study was 248. The definition of ``teleworking'' used is that
of ``teleworking or working from home at least part of the time.''
This means that some of the infections in their 35% ``teleworking''
rate may actually have occurred at the physical workplace, which
would mean OSHA's estimate of the number of teleworking cases is too
high.
---------------------------------------------------------------------------
Adjustment to physical workplace cases to remove cases from
community spread.
The remaining 818,348 (1,047,145-228,797) cases among people of
working age are attributed to workers who work in the physical
workplace (See Table IV.B.44, Row E). These cases are likely to be
partly due to community spread and partly to workplace transmission.
This analysis includes a simplifying assumption that the community
spread share is 20 percent.\100\ This leaves 654,678 cases attributed
to workplace transmission (818,348 x (1-20%)) (See, Row F).
---------------------------------------------------------------------------
\100\ This is based on the high incidence of workplace infection
documented in the Grave Danger chapter. Some of this research
includes a study of the Nashville Metro Health Department (November
20, 2020) which found 200 COVID-19 clusters occurring under 18
settings, 16 of which were workplace settings. Another paper cited
is Allan-Blitz et al., (December 11, 2020), which found 149,957
cases in Los Angeles associated with an occupation. Marshall et al.,
(2020) found half of the exposure by individuals to COVID-19
occurred in a workplace setting. Bui et al., (August 17, 2020) found
that 210 out of 277 COVID-19 outbreaks (76%) occurred in workplace
settings. Chen et al., (January 22, 2021) found that mortality rates
in working aged adults (18-65 years) increased 22% during the COVID-
19 pandemic compared to pre-pandemic periods. Other studies also
found elevated mortality risk for in-person workers (Hawkins, June
2, 2020).
---------------------------------------------------------------------------
Allocation of workplace transmission to section 502.
Next the remaining 654,678 cases among healthcare workers and non-
healthcare workers are allocated by their relative share of non-
teleworking employment, where healthcare workers are 13 percent (9%/(9%
+ 58%)) and non-health care workers represent the remainder, which is
87 percent (100% - 13%). The number of workplace cases for healthcare
workers is therefore 83,458 (13% x 654,678) (See Table IV.B.44, Row H).
Next, because these numbers are only for a single month, OSHA
multiplies these totals by six to get the total number cases during the
next six months: For healthcare workers, 500,746 cases (6 x 83,458).
(See Table IV.B.44, Row J).
Finally, OSHA reduces cases by vaccination rates, taking into
account vaccine effectiveness. OSHA's adjustment for vaccines has two
steps: (1) Removing some cases to account for vaccination preventing
them; and (2) adding back in some cases to reflect the fact that the
vaccine is not 100 percent effective, so a small number of people who
are vaccinated are still included in the number of COVID-19 cases.
For the first step, if OSHA simply assumed no one was vaccinated
during the period from which the raw data were drawn, and the
vaccination rate stays constant during the period of the ETS with an
average of 75 percent, the reduction for vaccination would be the
simple subtraction of 75 percent of the cases in the raw data.
But that would result in an over-reduction of cases because the
CDC's raw data does in fact already have some vaccination rates built
in. Healthcare workers were some of the first workers to be eligible
for vaccination. For the primary scenario, which is the data from
March/April 2021, OSHA estimates the vaccination rate for healthcare
workers at 50 percent during that period.\101\
---------------------------------------------------------------------------
\101\ See a March 2021 survey of healthcare workers done by the
Kaiser Family Foundation (KFF) (Kaiser Family Foundation, March 19,
2021).
---------------------------------------------------------------------------
In the second step, OSHA must account for the fact that vaccination
will not prevent all COVID-19 cases, so a small group of vaccinated
HCWs will still become COVID-19 cases even after being vaccinated
(although OSHA assumes that the vaccine will still prevent all of them
from dying). In other words, if the vaccine efficacy rate was 100
percent, then OSHA would just focus on vaccinated cases versus
unvaccinated cases, but the vaccines are assumed to have only an 85.2
efficacy rate at preventing COVID-19, which is the average rate derived
from the three available vaccines.\102\ The formula adjusting for the
reduction of vaccinated cases from the 50 percent baseline, as further
adjusted to account for vaccine inefficacy, is:
---------------------------------------------------------------------------
\102\ Vaccine efficacy against infections was calculated by
taking a simple average of the efficacy rates of the three vaccines
that are currently being employed, found from their clinical trial
results: (Pfizer--94.6% Moderna--94.1%, Johnson & Johnson--66.9% for
an average efficacy of 85.2%). See FDA (December 11, 2020), FDA
(December 18, 2020), FDA (February 4, 2021).
cases = (raw data from Table IV.B.44, Row J) * (((75% vaccinated) * (1-
vaccine efficacy) + (1-75%) unvaccinated)/((50% vaccinated) * (1-
---------------------------------------------------------------------------
vaccine efficacy) + (1-50%) unvaccinated))
which translates to
cases = (500,746 adjusted HCW with COVID during month of March/April
2021) * ((0.75 * 0.148) + 0.25)/(0.5 * 0.148) + 0.5)) = 314,929
[314,969 when adjusted for rounding]
or
cases = (500,746) * 0.361/0.574 = 314,929 [314,969 when adjusted for
rounding]
OSHA multiplies the raw data by the ratio of the ETS period adjustment
to that during the data period. For the primary scenario, the result is
that 62.9 percent of raw data cases remain.
For the alternative scenario, which is based on a full year of data
for which vaccination was not available until December 2020 when
vaccines were FDA-authorized for use, the vaccination rates for
healthcare workers was lower than 50 percent. For the average rate for
the alternative scenario the agency assumes a rate of 50%/4 = 12.5
percent. Based on the same adjustment formula used for the primary
scenario, the number of cases in the alternative scenario is reduced by
40.4 percent.\103\ Since the base level of vaccinations was lower for
the alternative scenario, a smaller number of cases are removed from
that total to account for vaccinations.
---------------------------------------------------------------------------
\103\ ETS adjustment -36.1%, alternative scenario adjustment -
9.4%, so 36.1/89.4 = 40.4%.
---------------------------------------------------------------------------
As a result, vaccinations lower the number of cases for HCWs to
295,284. Table IV.B.44 provides these final totals of cases after the
effects of vaccination in Row K.
Another way of explaining this process is that OSHA's method of
calculating the number of infections prevented by the ETS involves a
seven-step process. Again, OSHA illustrates this process from the
``primary'' baseline, although this method is also applicable to the
alternative baseline estimate as well.
First, a count of monthly infections is created by summing daily
infections from CDC's daily tracking data. In this example, for the
period between March 19 and April 19 there were 2,041,229 new
infections (or cases) counted by CDC that month (CDC, April 20, 2021,
file: ``case_daily_trends__united_states''). Next, a count of monthly
infections for working age adults is created by multiplying the number
of recent cases (2,041,229) by the share of those cases (0.74) in which
the person infected with COVID-19 was a working-age adult (aged 18-
64).\104\ The product is 1,513,606 (shown in Table VI.B.43). In the
third step, the share of the population ages 18-64 who are employed
(0.69) is multiplied by the previous product to produce the number of
workers infected in the period March 19-April 19 (1,513,606 x 0.69 =
1,047,145) (see Table IV.B.44, Row C). The fourth step is the removal
of community transmission cases, which was explained above. In that
step 228,797 cases for teleworkers are removed, along with an
additional 20 percent for community spread for in-person workers,
leaving a total of 654,678 cases (see Table IV.B.44, Rows D through F).
For the fifth step, the number of workers infected from March 19-April
19 is divided between HCWs and NHCWs by using the share of each worker
type found in OSHA's industry profile; about 87 percent are NCHWs, and
the remaining 13 percent are HCWs.\105\ For NHCWs, this product is
571,221 (0.87 x 654,678),\106\ and for HCWs, the figure is the
remainder, 83,458 (654,678-571,221) (See Table IV.B.44, Rows G and H).
In the sixth step, the number of NHCW and HCW infections is multiplied
by 6 to convert the estimate for one month to a six-month period. For
NHCWs, this is 3,427,323 (571,221 x 6) infections. For HCWs, this is
500,746 (83,458 x 6) infections. Table IV.B.44 summarizes these results
(See Rows I and J).
---------------------------------------------------------------------------
\104\ Because the percentages reported throughout the text are
rounded, numbers calculated using these percentages may differ
slightly from the exact numbers reported in the text or tables.
\105\ The Industrial Profile for the ETS provides employment
data for covered employees. This allows the analysis to separate
HCWs from NHCWs. In the profile there are 124,286,764 total workers:
105,278,752 NHCWs, and 10,601,734 HCWs. Therefore, NHCWs are 87.26
percent of the total workers, and HCWs are 12.74 percent of the
total workers. (Source: Cost analysis.)
\106\ Because the percentages reported throughout the text are
rounded, numbers calculated using these percentages may differ
slightly from the exact numbers reported in the text or tables.
---------------------------------------------------------------------------
In the final step of determining the number of cases, the numbers
HCW cases are further reduced to account for vaccination as described
above (see Rows K and L).
Fatalities
OSHA's estimation of fatalities uses a slightly modified seven-step
procedure to take advantage of the HCW infection and fatality data
reported to CDC. It is the same methodology used for determining the
number of infections, but beginning with the baseline of CDC data on
fatalities instead of infections. Again, using March 19, 2021 to April
19, 2021 as the basis for the primary scenario, for the first step a
count of monthly fatalities is created by summing daily fatalities from
CDC's tracking data (CDC, April 20, 2021). In this example, for the
recent month there were 23,642 new deaths counted by CDC in that
period. Next, a count of monthly fatalities for working age adults is
created by multiplying the number of deaths from March 19-April 19,
2021 (23,642) by the share of deaths among adults ages 18-64 out of all
deaths from COVID-19 for that month (0.19). This product is 4,561
deaths of working-age adults in the March/April 2021 time period. In
the third step, the share of the population aged 18-64 who are employed
(0.69) is multiplied by the previous product to produce the number of
worker deaths in the recent month (4,561 x 0.69 = 3,155). Fatalities
attributed to community spread are removed, following the same logic as
was used above for infection cases. There were 689 teleworker
fatalities (by definition attributable to community spread), and after
removing the 20 percent of in-person worker fatalities attributable to
community spread, the remainder is 1,973 COVID-19 worker fatalities
attributable to the workplace for that month. The six-month total of
11,835 worker fatalities (for both NHCWs (10,180) and HCWs (1,656)) is
obtained by multiplying the estimated number of worker deaths for one
month by 6.
For the fifth step, the focus shifts to measurement of HCW
fatalities. Since June 2020, CDC has been reporting HCW infections and
fatalities. While there is significant underreporting of HCW status and
possibly HCW infections and fatalities (making this data unsuitable for
direct analysis of HCW impacts), OSHA believes that the ratio of
fatalities to infections for HCWs is unlikely to be much affected by
underreporting of total cases.\107\ OSHA therefore uses the ratio of
HCW fatalities to HCW infections (0.0033), which could be considered a
provisional HCW case fatality rate, to produce the estimate of work-
related HCW fatalities.\108\ For the primary scenario, multiplying
(0.0033 x 500,746 HCW infections) yields 1,656 HCW fatalities projected
over the next six months.\109\
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\107\ OSHA has examined CDC's data on HCW infections and
fatalities, and is only using those data to calculate a preliminary
case fatality ratio. Because the healthcare occupation is rarely
reported on the CDC's COVID-19 Reporting Form, it is likely that
fatalities and, especially, infections are vastly undercounted.
\108\ On March 23, 2021, the CDC Daily Tracker website showed a
total of 1,557 HCW fatalities and 470,942 HCW infections since March
2020. The fatalities divided by the infections produces a ratio of
0.0033 (CDC, April 20, 2021).
\109\ Because the percentages reported throughout the text are
rounded, numbers calculated using these percentages may differ
slightly from the exact numbers reported in the text or tables.
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In the final step for determining the total number of work-related
fatalities that would occur over the next six months without the ETS,
the effects of vaccinations on the number of fatalities are shown. For
fatalities, OSHA assumes that vaccination will prevent all
fatalities for those vaccinated. For HCWs, OSHA assumes that 75 percent
will be vaccinated. The vaccine fatality adjustment explained above is
ultimately expressed as a 50 percent reduction. Because OSHA assumes
that vaccination prevents all fatalities, these adjustments are the
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following:
Fatalities = (raw data from Table VI.B.45, Row K) * (((75%
vaccinated) * (1-100 percent vaccine efficacy) + (1-75%) unvaccinated)/
((50% vaccinated) * (1-100 percent vaccine efficacy) + (1-50%)
unvaccinated))
which translates to
fatalities = (1,656) * ((0.75*0.0 + 0.25)/(0.5*0.0) + 0.5)) = 828
or
fatalities = 1,656 * 0.25/0.5 = 828
In the case of the primary scenario, this equation collapses
because two terms (in bold above) are multiplied by zero, leaving the
multiplier as (0.25)/(0.5) = 0.5, so the fatalities are reduced by half
by the additional vaccinations that would happen over the next six
months. Using the same equation for the alternative scenario,
fatalities are reduced by a factor of 0.29:
Fatalities = (2,034) * ((0.75 * 0.0 + 0.25)/(0.125 * 0.0) + 0.875)) =
581
The final number of fatalities, after taking into account community
spread, preventiveness, and vaccination is 776 HCW under the primary
analysis, and 545 HCW under the alternative analysis (Table VI.B.4546,
Row M).
f. Infections and Deaths Prevented by the ETS
A critical factor in the estimation of the benefits of the ETS is
the percentage of baseline infections and deaths that would be avoided
by full implementation of all ETS requirements. This final adjustment
to reach the number of cases prevented is summarized in Row L of in
Need for Specific Provisions (Section V of the preamble), OSHA reviews
numerous studies evaluating the effectiveness of various infection
control practices in preventing infectious diseases. Given the
consistent, multi-layered approach required by the ETS, the rate of
COVID-19 infection prevention in non-healthcare and healthcare settings
covered by the ETS should approach 100 percent, assuming full
compliance with all requirements.
For the benefits section, OSHA suggests that overall program
effectiveness for workers has two underlying components: Workplace
preventiveness and community spread. Workplace preventiveness is how
well the ETS works to prevent workplace transmission. The community
spread is the transmission that happens outside of the workplace that,
by definition, the ETS is incapable of preventing.\110\ These factors
can be explained by the equation: Overall effectiveness =
Preventiveness after taking into account Community Spread. OSHA
believes the standard will have preventiveness coefficients of about 94
percent of HCW workplace transmissions (see earlier calculations) and,
taking into account a community spread of 20 percent, for an overall
effectiveness rate of 75 percent for HCWs.\111\ A sensitivity analysis
explores potentially higher values of community spread, much lower
monthly case and fatality counts, and the impact of lower overall
effectiveness rates on the estimates of monetized health benefits.
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\110\ Community spread would likely be further reduced because
of reductions of workplace spread, but OSHA has not attempted to
take that into account in order to account for a worst-case scenario
in which only small reductions would occur.
\111\ The equation for 75 percent overall effectiveness is: 0.75
= 0.9375 (1-0.20) where 0.20 is community spread and 0.9375 is
preventiveness.
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Health Care Worker Population
For its main estimates of benefits, OSHA has selected a 75 percent
overall effectiveness rate of the ETS for all HCWs, taking into account
both the workplace preventiveness of the ETS and community
transmission. This higher rate reflects the expectations that workers
covered by the ETS will have enhanced ventilation and that roughly a
quarter of those workers are required to wear respirators and other PPE
because of exposure to people with suspected or confirmed COVID-19.
Additionally, employers in these settings are already accustomed to
infection control practices, even if these practices are different
under normal circumstances. Then, as a sensitivity analysis, the agency
also presents results using a 56 percent overall effectiveness rate,
which corresponds to an overall higher rate of community spread of 40
percent.\112\ These alternative effectiveness and preventiveness rates
are used to derive estimates of the number of COVID-19 infections and
deaths prevented by the ETS among HCWs.
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\112\ The 56 percent overall effectiveness rate was selected for
the sensitivity analysis because it is the mathematical result of
doubling the community spread from 20% to 40%. This equation shows
the overall effectiveness rate equals the preventiveness rate
(0.925) time the non-community spread, which is 60 percent, or 100
percent minus 40 percent [0.56 = 0.925 * (1-0.4)].
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Applying the 75 percent ETS effectiveness rate to the baseline
estimates, along with a vaccination rate of 75 percent for HCWs, yields
benefits of the ETS of 295,284 confirmed COVID-19 HCW infections and
776 deaths prevented over a six-month period as a result of the ETS
(see Table VI.B.41). Applying the 56 percent ETS effectiveness
sensitivity rate to the March/April estimates yields benefits of
221,463 confirmed COVID-19 HCW infections and 466 deaths prevented over
the six-month period as a result of the ETS.
g. Monetizing ETS Health Benefits
OSHA here provides estimates of the monetized value of the COVID-19
infections and fatalities prevented as a result of the ETS. These
estimates are included solely to facilitate the type of analysis
required by E.O. 12866 because the OSH Act, as interpreted by the
courts, prohibits OSHA from using cost-benefit analysis as a basis for
regulatory decisions. See, e.g., Pub. Citizen Health Research Grp. v.
U.S. Dept. of Labor, 557 F.3d 165, 177 (3d Cir. 2009) (``the Supreme
Court has conclusively ruled that economic feasibility does not involve
a cost-benefit analysis''), citing Am. Textile Mfrs. Inst., Inc. v.
Donovan, 452 U.S. 490, 513 (1981).
OSHA has developed estimates of monetized benefits under important
baseline assumptions of partial worker vaccination at the time the ETS
takes effect resulting in an average worker vaccination rate of 75
percent for HCWs over the course of the ETS. This is not an endpoint
prediction of vaccination rates, but rather an approximate average rate
attained over the course of the ETS. This is an assumption of what the
estimated total vaccination rates will be for HCWs under age 65 about
three or four months into the ETS, given that some vaccines take two to
six weeks to be fully effective after the first shot.
Value of Each ETS Fatality Avoided
The agency's methodology for monetizing benefits is based on
relevant academic literature and approaches OSHA and other regulatory
agencies have taken in the past for similar regulatory actions.\113\
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\113\ See, for example, the discussion in the FEA in support of
the 2016 silica final rule (OSHA-2010-0034-4247; ``Benefits and Net
Benefits'') (OSHA, March 25, 2016).
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To estimate the monetary value of each COVID-19-related fatality
prevented as a result of the ETS, OSHA relies on estimates developed
from the willingness of affected individuals to pay to avoid a marginal
increase in their risk of dying.\114\ While a willingness-to-pay (WTP)
approach clearly has theoretical merit, it should be noted that
an individual's willingness to pay to reduce the risk of death may tend
to underestimate the total societal willingness to pay, which could
include the willingness of others--particularly immediate family--to
pay to reduce that individual's risk of fatality.\115\
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\114\ This is the procedure that OMB recommends in Circular A-4.
See (OMB, 2003), pp. 18-19.
\115\ See, for example, Thaler and Rosen (1976), Sunstein
(January, 2004), or Viscusi et al., (January 1, 1988). For a view
that such underestimation of the social willingness to pay would be
offset, more or less, by an analogous social underestimation of
costs, see Bergstrom (March, 2006).
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For estimates using the WTP concept, OSHA relied on existing
studies of the imputed value of fatalities avoided based on the theory
of compensating wage differentials in the labor market. These studies
rely on certain critical assumptions for their accuracy, particularly
that workers understand the risks to which they are exposed and that
workers have legitimate choices between high- and low-risk jobs. Actual
labor markets only imperfectly reflect these assumptions.\116\ A number
of academic studies, as summarized in Viscusi and Aldy (August, 2003),
have shown a correlation between higher job risk and higher wages,
suggesting that employees demand monetary compensation in return for a
greater risk of injury or fatality. The estimated trade-off between
lower wages and marginal reductions in fatal occupational risk--that
is, workers' willingness to pay for marginal reductions in such risk--
yields an imputed value of an avoided fatality: The willingness-to-pay
amount for a reduction in risk divided by the reduction in
risk.117 118 OSHA has used this approach in many recent
proposed and final rules.\119\
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\116\ On the former assumption, see the discussion in the FEA in
support of the 2016 silica final rule (OSHA-2010-0034-4247; p. II-5
to II-7) (OSHA, March 25, 2016). On the latter, see, for example,
the discussion of wage compensation for risk for union versus
nonunion workers in Dorman and Hagstrom (October 1, 1998).
\117\ For example, if workers are willing to pay $100 each for a
1/100,000 reduction in the probability of dying on the job, then the
imputed value of an avoided fatality would be $100 divided by 1/
100,000, or $10,000,000. Another way to consider this result would
be to assume that 100,000 workers made this trade-off. On average,
one life would be saved at a cost of $10,000,000.
\118\ Note that, consistent with the economics literature, most
of the available value-of-a statistical-life (VSL) estimates are for
reducing the risk of an acute (immediate) fatality. They do not
include an individual's willingness to pay to avoid an illness prior
to fatality, which is separately estimated in the following section.
\119\ See, for example, the preliminary economic analysis for
the proposed hexavalent chromium rule (Document ID OSHA-H054A-2006-
0064-1466 (OSHA, 2004)), the benefits analysis for the final
hexavalent chromium rule (Document ID OSHA-H054A-2006-0064-2530
(OSHA, 2016b)), and the preambles for the proposed and final
respirable crystalline silica rules (78 FR 56274; 81 FR 16286).
---------------------------------------------------------------------------
Viscusi and Aldy (August, 2003) conducted a meta-analysis of
studies in the economics literature that use a WTP methodology to
estimate the imputed value of life-saving programs and found that each
fatality avoided was valued at $6.7 million in 2000 dollars. Using the
GDP Deflator (BEA, 2021), this $6.7 million base number in 2000 dollars
yields an estimate of $9.73 million in 2019 dollars for each fatality
avoided. OSHA is also using $9.73 million as the monetary value of each
estimated 2021 fatality prevented as a result of the ETS.
Value of Each COVID-19 Related Infection Avoided
OSHA also reviewed the available research regarding the dollar
value of preventing a generic injury or illness. Using WTP to value
non-fatal injuries or illnesses is the approach recommended in OMB
Circular A-4 (OMB, September 17, 2003). In the paper cited immediately
above, Viscusi and Aldy (August, 2003) conducted a critical review of
39 studies estimating the value of a statistical injury or illness. The
authors found that most studies resulted in estimates in the range of
$20,000 to $70,000 per injury or illness (in 2000 dollars), although
several studies resulted in higher estimates.\120\ A mid-point WTP
estimate for a generic injury or illness would therefore be $45,000, to
be raised to $65,364 (2019 dollars) to account for the rise in the cost
of living since 2000, the base year for the monetized values estimated
by Viscusi and Aldy (August, 2003).
---------------------------------------------------------------------------
\120\ That some studies used an overall injury/illness rate, and
others used only injuries or illnesses resulting in lost workdays,
partly explains the variation in these estimates.
---------------------------------------------------------------------------
For this value to be a representative WTP estimate for the average
COVID-19 infection, the severity of the typical COVID-19 infection must
be similar to that of the typical OSHA recordable injury or illness.
While most COVID-19 infections are asymptomatic or mild and involve
maybe two weeks of forgone earnings and minor medical bills (totaling
perhaps $1,000-$5,000), others are more severe. Some will involve
hospitalization and, in some cases, long-term disability.\121\ For
those persons who have not received an FDA-authorized COVID-19 vaccine,
the percentage of COVID-19 cases involving hospitalization is still
fluctuating, with perhaps 10 percent being a reasonable estimate. The
medical and foregone earnings cost per hospitalization may range from
$10,000 to $300,000 or more.
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\121\ For deaths that would occur after workers are hospitalized
for COVID-19, the benefit of the avoided fatality was included in
the previously-described WTP value of an avoided acute fatality.
OSHA has not included in its estimates of ETS benefits the value of
a premature death due to a chronic COVID-19 disability, because the
likelihood of such occurrences is too speculative to be estimated at
this time.
---------------------------------------------------------------------------
There is a growing body of literature on chronic illnesses that are
linked to prior COVID-19 infections. The coronavirus, once it enters
the body, may attach itself to any organ or tissue, including the
lungs, heart, kidneys, brain, and nervous system. This can lead to
acute or chronic health effects, such as stroke, heart attack, kidney
failure, loss of brain function, extreme mental and physical fatigue,
and various other deleterious effects.\122\ Further discussion and
summary of evidence concerning the persistence of COVID-19 symptoms
after hospital discharge and the occurrence of longer-term disabilities
is presented in Grave Danger (Section IV.A of the preamble). The cost
of chronic conditions resulting from COVID-19 infections is difficult
to estimate because the duration and severity of those chronic
conditions, as well as subsequent reductions in life expectancy (not
considered in these estimates of ETS health benefits), are not well
known at this time. In other rulemakings, however, OSHA has identified
costs (all inflated to 2019 dollars) for other chronic diseases, such
as chronic silicosis (cost of injury of approximately $400,000 from
Miller (November 22, 2005)); chronic bronchitis (approximately $600,000
from EPA (2008)); and chronic beryllium disease (approximately $2.2
million for direct morbidity and medical costs from Bartell et al.,
(2000)).
---------------------------------------------------------------------------
\122\ Both the medical and popular press have recognized the
lingering and possibly longer-term multi-organ health effects of the
disease and given it a name: ``long COVID.'' See for example Huzar
(April 12, 2021) and Walton (April 11, 2021).
---------------------------------------------------------------------------
Because there is still some uncertainty surrounding the frequency
and severity of COVID-19 infections and their distribution, OSHA has
chosen to use the earlier estimate presented for a generic non-fatal
injury or illness of $65,364 as a reasonable approximation of the WTP
value of an avoided COVID-19 non-fatal infection among workers who have
not received the COVID-19 vaccine.
Estimated ETS Monetized Health Benefits
With FDA authorization of several COVID-19 vaccines and increased
vaccination efforts by the Administration, OSHA believes that by the
date of publication of the ETS, approximately 70 percent of HCWs will
have been fully vaccinated. Based on early results, the vaccines appear
to be reducing the number of COVID-19 cases. Crucially, they appear to
be virtually eliminating COVID-19
fatalities and significantly reducing both the number and severity of
COVID-19 infections among the vaccinated population. Still, none of the
vaccines are 100 percent effective, and their usefulness against newer
strains of COVID-19 remains uncertain. With that as background, OSHA
has adjusted the baseline number of COVID-19 infections for HCWs by the
vaccine effectiveness.\123\ OSHA will use the same Value of Statistical
Illness (adjusted for inflation) of $65,364 used in previous rules. In
addition, OSHA has reduced the estimated number of COVID-19 fatalities
prevented by 75 percent for HCWs to account for vaccination in the
workforce, but retained the WTP value of $9.73 million for each
fatality avoided.
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\123\ The vaccines are about 85.2 percent effective against
severe illness, so for example the overall effectiveness rate for a
vaccine given to 30 percent of a population would be (0.3 x 100%) +
(0.7 x 0.148) = 40.3%.
---------------------------------------------------------------------------
The monetized values of infections and fatalities prevented by the
ETS, accounting for HCW vaccination, are shown Table VI.B.46 below.
Table VI.B.46 also includes the subsequent estimated health benefits of
the ETS under various scenarios after taking into account the effect of
worker vaccinations in the baseline. Table VI.B.47 presents the results
when the estimates in Table VI.B.46 are subject to a sensitivity test
using 56 percent overall effectiveness of the ETS, while recognizing
the presence of worker vaccinations in the baseline and accounting for
40 percent community spread versus 20 percent in the baseline
analysis.\124\
---------------------------------------------------------------------------
\124\ 56 percent = 70 percent preventiveness x (1-20 percent
community spread).
[GRAPHIC] [TIFF OMITTED] TR21JN21.059
[GRAPHIC] [TIFF OMITTED] TR21JN21.060
Low-Case Sensitivity Analysis
Cases have declined significantly in recent weeks, and perhaps a
combination of natural causes, herd immunity, vaccinations, and
government policy will result in case numbers continuing to fall
dramatically. To consider this possibility, a sensitivity analysis that
takes into account dramatically lower case and fatality counts is
presented below. Rather than choosing a relatively low historic month,
like June 2020 (847,000 new cases, 21,635 deaths), OSHA creates a
future fictional month, called ``month 13'', based on 20 percent of the
average monthly cases over the pandemic (April 2020-May 2021:32,798,861
cases, or 2,522,989 cases/month). This is 504,598 cases and taking 20
percent of total fatalities, 8,860 fatalities. This estimate would be
considerably lower than the May 2021 monthly case count of 861,373
cases and 14,943 fatalities. ``Month 13'' also has about one-quarter of
the cases of the ``primary'' scenario, and about 58 percent of the
fatalities of the ``primary'' scenario.\125\
---------------------------------------------------------------------------
\125\ OSHA presents these lower numbers of cases and fatalities
as a sensitivity analysis rather than in the primary estimate in
part because the primary estimate is used consistently in both
benefits and costs. Assumptions about the number of cases impact
both costs and benefits, and OSHA used the higher numbers from the
primary estimate for a more conservative (i.e., higher) projection
of costs, thereby ensuring a more robust economic feasibility
analysis. OSHA believes the numbers of cases and fatalities that are
included in the primary scenario are more appropriate for the
purposes of these analyses, while the cases identified in the
sensitivity analysis provide sufficient contrast in the event that
the case numbers were to drop dramatically.
---------------------------------------------------------------------------
Using all of the other assumptions about preventiveness, community
spread, and vaccines, explained above, the fictitious ``month 13''
month would translate into significant benefits over a six-month
period, including 72,893 HCW cases prevented over six months, 192 HCW
fatalities prevented, and monetized benefits of $6.6 billion during
that period.
h. Conclusion
In this chapter, OSHA examined the potential of the ETS to prevent
infections and deaths from COVID-19
among workers in the U.S. OSHA analyzed the possible numbers of cases
in the absence of an ETS using historical monthly data on infections
and fatalities during the pandemic. The monthly baseline scenarios were
based on a primary and an alternative estimate. The primary estimate
reflects cases and fatalities during March/April 2021 while the
alternative estimate is based on an average monthly level of cases and
fatalities for all the pandemic months (April 2020-April 2021).
The benefits of the ETS simply reflect the reduction in infections
and fatalities under different estimates of the overall effectiveness
of the ETS (75 percent for HCWs and 56 HCWs as a sensitivity test) and
assuming an average vaccination rate of 75 percent for HCW. Monetized
benefits were calculated based on WTP estimates developed in the
academic literature and applied in prior OSHA rules. Infections and
deaths prevented among all health care workers, based on the primary
estimate, are 295,284 and 776, respectively. Monetized benefits for the
primary estimate, assuming a 75 percent overall effectiveness rate, are
$26.8 billion (with the alternative scenario yielding monetized
benefits of $20.5 billion).
OSHA's ``primary'' benefits estimate is the agency's preferred
scenario. The ``primary'' scenario uses numbers of cases and deaths
that occurred from March 19, 2021 through April 19, 2021 and assumes an
average vaccination rate of 75 percent for HCW 75 percent overall
effectiveness rate for the HCW.
OSHA's analysis indicates that over a 6-month period the ETS would
prevent 776 deaths at a cost of about $4 billion, while the value of
fatalities avoided is $7.5 billion. This simple calculation ignores the
additional health benefits provided by avoided infections.
i. Other (Non-Health) Benefits of the ETS
It is also helpful to put this rule in context. OSHA's regulatory
authority extends only to workplaces, and not to society as a whole. As
a result, its feasibility analyses are necessarily limited to what is
feasible for the workplaces subject to its authority, and the benefits
analyses it performs for other purposes also focus on the benefits to
workers. Therefore, the foregoing analysis follows the normal OSHA
practice of considering only the costs and benefits to workers and
their employers and fulfills the agency's legal and analytical
obligations with respect to the ETS.
The pandemic, however, affects the economy as a whole, and affects
workplaces within that context. Although the primary purpose of this
COVID-19 emergency temporary standard (ETS) is to help prevent health
care worker infections and deaths due to the pandemic, the ETS also
helps create conditions that will facilitate an equitable economic
recovery. While vaccines show much promise, it will take months before
all of the workforce is fully vaccinated, and even then there is
uncertainty about existing vaccines' efficacy against new virus
variants. Workplace safety measures such as physical distancing, face
coverings, and physical barriers are still needed in parts of the
healthcare sector to prevent immediate infections and reduce the spread
of infections and, thereby, speed and strengthen the economic recovery
(Chudik et al., April, 2021). Such measures will not only safeguard the
health and employment status of vulnerable workers, but will also
provide visible forms of protections to patients to restore consumer
confidence.
More importantly, the ETS benefits society by reducing the spread
of the virus. An uninfected health care worker cannot infect others in
the community, resulting in better control of the pandemic overall. If
the pandemic is better contained in this industry, widespread economic
functions have a greater chance of continuing.
Healthcare workers who are less worried about being infected and
losing their lives or ability to work are more likely to have the
confidence to engage in normal consumption rather than saving to guard
against medical costs and loss of income. Thus, the protections of this
ETS will lower concerns about infection and help give individuals a
sense of safety and security, which will in turn help stimulate
economic activity.
The economic impacts of the pandemic have been unevenly distributed
across demographic and socioeconomic groups and have exacerbated
inequalities. The initial negative impact on employment was larger for
women, minorities, the less educated, and the young, even after
accounting for industry and occupation (Lee et al., January 1, 2021).
Lockdowns of schools and businesses to prevent the spread of COVID-19,
which the successful implementation of the ETS will help avoid, have
had particularly large effects on vulnerable groups, such as women, due
to the disproportionate burden women face in caring for children
(Caselli et al., 2020). Particularly, low-income workers in frontline
healthcare industries are disproportionately Black, Hispanic, female,
and foreign born (Leibenluft and Olinsky, April 20, 2020). Again, OSHA
expects the stimulative effects of the ETS will help ameliorate these
equity concerns created by the pandemic.
Beyond their direct function in protecting workers, several of the
provisions of the ETS have important economic effects. One area of
particular importance is that of paid medical removal protection (MRP).
MRP is a crucial part of this emergency temporary standard. Paid MRP
benefits are not the same as paid sick leave, since the former are to
ensure that (potentially) contagious workers who cannot work remotely
or in isolation may be removed from the workplace without losing pay,
thereby encouraging them to take part in the kind of COVID-19 exposure
prevention program created by this standard. But the benefits of paid
MRP are similar to paid sick leave for these purposes. Indeed, like
paid sick leave, paid MRP encourages workers who have been exposed to
the virus to self-isolate, thereby containing and mitigating the spread
of the virus. Paid MRP, like paid sick leave, allows workers who are
(potentially) infected to stay home rather than infect their coworkers
as collateral damage (OECD, 2020). Keeping these workers out of the
physical workplace lowers the transmission of COVID-19 and saves lives
(McLaren and Wang, December 2020). States that gained access to paid
sick leave through the Families First Coronavirus Response Act (FFCRA)
saw around 400 fewer confirmed cases per state per day relative to the
pre-FFCRA period and to states that had already enacted sick pay
mandates before enactment of the FFCRA (Pichler et al., October 15,
2020).
Paid sick leave also helps reduce income inequality. The ability to
take paid family or medical leave is highly unequal. Low-wage workers
are less likely to have access to paid leave and tend to take unpaid
leave at higher rates than other groups, though they take less leave
overall (Sawhill et al., December 5, 2019). A 2017 study of the
distributional impact of three policy models for providing paid sick
days found that a national paid sick day policy would benefit
proportionately more women than men and proportionally more workers of
color than white workers, compared to the then current policy. Low-
income workers would see their share of paid sick days increase the
most (IMPAQ International LLC, January, 2017). While the American
Rescue Plan of 2021 does not extend the mandate for paid sick leave, as
discussed above, the feasibility of this provision is enhanced by the
tax credits that are available to employers
who provide MRP as required by the standard.
Paid sick leave also helps ward against the impact of losing the
sick workers, and their families, as consumers. It is worth noting that
the American Rescue Plan of 2021 also includes stimulus checks to
individuals in the amount of $1,400, which is roughly the amount of the
maximum required weekly payments under the MRP provision of the ETS,
although the ETS does not prevent employers from paying high-paid
workers their full wages or salary. This reflects the significance of
the impact that the loss of even a single week's income can have on the
economy, and the ETS would prevent this loss on the consumer side.
BILLING CODE 4510-26-P
Appendix VI.B.A: Healthcare and Other Covered Occupations in the Scope
of the ETS
Table VI.B.A.1. lists the BLS occupations used
by OSHA to designate employees in settings where healthcare and
healthcare support services are performed and the entities that employ
them.
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[GRAPHIC] [TIFF OMITTED] TR21JN21.063
Appendix VI.B.B: Average Loaded Wages by NAICS Code and Healthcare
Setting
Table VI.B.B.1 presents the average loaded wages for covered
employees by NAICS code and healthcare setting. Both averages are
weighted by covered employment.
[GRAPHIC] [TIFF OMITTED] TR21JN21.064
[GRAPHIC] [TIFF OMITTED] TR21JN21.065
Appendix VI.B.C: Average Cost per Establishment by 6-Digit NAICS Code
Table VI.B.C.1 presents the average incremental cost per
establishment for compliance with the ETS.
[GRAPHIC] [TIFF OMITTED] TR21JN21.066
Appendix VI.B.D: Adjustment to Economic Analysis for Pandemic Shock and
To Forecast Out to ETS Time Period
For many regulatory economic analyses, the agency uses the most up-
to-date economic data as its baseline to describe the current state of
the economy, as discussed above. It then applies the anticipated
changes due to the new OSHA standard or regulation to that baseline.
However, even the most current data OSHA uses in a typical economic
analysis--including employment, number of establishments, revenue--
represent economic conditions from at least one calendar year in the
past. Even with that lag in the data due to reporting and compilation
time, the basic structure of the economy changes slowly, so the
recent past is a reasonable predictor of the near future.
Given the unique circumstances of the pandemic and its economic
disruption, OSHA's usual approach does not make sense for the present
analysis. The agency has therefore also made adjustments to the
baseline industry profile to account for the economic conditions that
are expected to persist during the time period in which this ETS will
be in effect.
The baseline employment and revenue numbers were obtained from the
2017 Economic Census (the most current information available from the
Economic Census) (U.S. Census Bureau, 2021). Revenue values were
adjusted to 2019 dollars using the BEA's GDP deflator (BEA, 2021). OSHA
adopts these adjusted 2019 revenue data as representing the state of
the economy before the pandemic hit in 2020. Similarly, OSHA uses 2018
OES data for wages, brought forward to 2019 using the GDP deflator to
be consistent with revenue data (BLS, March 29, 2019). To adjust for
the economic effects of the pandemic and provide a more reasonable
estimate of employment and revenue numbers for the period during which
the ETS will be in effect, the agency used other national datasets to
derive percentage changes to this baseline 2019 data.
To adjust for changes in employment since 2019, OSHA relies on the
BLS' Current Employment Statistics (CES), which is published monthly
and provides estimates by NAICS code (BLS, December, 2020). At the time
of this analysis, the December 2020 CES, which contains full data
through November 2020, had been published. The agency uses average
employment, within each NAICS industry, over all months of 2019 as the
``normal'' base economy before COVID-19 arrived. OSHA then uses the
percentage difference between the reported 2019 employment and the
reported employment from November 2020 as its measure of the pandemic
shock, and adjusts the 2019 data by this percentage. The average
employment decline across all covered NAICS industries over the period
2019 to November 2020 is three percent.
The adjustment described above is intended to make the employment
estimates per establishment more representative of conditions as of the
end of 2020. The ultimate objective, however, is to estimate economic
conditions during the forthcoming 6-month period. The exact timing of
the ETS at the time of this analysis is not known; OSHA assumes that
the end of the ETS occurs later in 2021. The agency uses forecasts of
aggregate growth in GDP from the well-known Conference Board (The
Conference Board, May, 2021) to extend its employment estimates from
the end of 2020 through the 3rd quarter of 2021. See Table VI.B.D.1 for
the Conference Board's forecasts.\126\
---------------------------------------------------------------------------
\126\ Since GDP is not produced by labor alone, and hence
employment should not be strictly proportional to GDP, the agency
makes a further adjustment to account for this. One method is to
assume GDP takes the form of an aggregate Cobb-Douglas function,
GDP=LbK(1-b), where L is aggregate employment,
K is capital (but here represents everything other than employment),
and b is between 0 and 1. The Cobb-Douglas function has constant
returns to scale. If, as some economists argue a better
representation has increasing returns to scale, this will actually
lower our estimate of the amount of labor growth entailed by a given
amount of growth in GDP. This would similarly be true for any type
of Solow residual-like technological change. In either case, less
labor will be needed to reach a given GDP level. In this simple
setup, b in fact equals the labor share of income in GDP (the wage,
w, is the marginal product of capital w=dGDP/dL=b*(K/
L)1-b. Then total wages is w*L=b*L*(K/L)1-b=b
LbK(1-b)=b*GDP. Hence the wage share=w*L/
GDP=b*GDP/GDP=b). For the wage share we do have estimates, see FRED
variable LABSHPUSA156NRUG, which most recently has an estimate for
2019 of 59.7 percent. Note a recent paper (Autor et al., February 3,
2020) on the labor share issue is ``The Fall of the Labor Share and
the Rise of Superstar Firms.'' Finally to see how this is reflected
in employment growth estimates, if the Cobb-Douglas assumption
holds, then with growth, g, OSHA has future GDP as (1+g)*GDP =
(1+g)* LbK(1-b) =
((1+g)*L)b((1+g)K)(1-b) so employment grows by
(1+g)b or (1+g).597. This is the adjustment
OSHA made to GDP growth, to account for other factors used in
production, in calculating future employment growth.
[GRAPHIC] [TIFF OMITTED] TR21JN21.067
For revenue (and by extension, profits) OSHA also uses various
estimates to adjust the data forward from the 2019 baseline. First, the
agency uses the percentage change in GDP by industry, reported by the
BEA, to adjust revenue and profits through the 3rd quarter of 2020 (see
Table VI.B.D.2).\127\
---------------------------------------------------------------------------
\127\ GDP data are available, at the time of this analysis,
through the 3rd quarter 2020 at the 2 digit NAICS level (BEA, March
29, 2021).
---------------------------------------------------------------------------
[GRAPHIC] [TIFF OMITTED] TR21JN21.068
[GRAPHIC] [TIFF OMITTED] TR21JN21.069
BILLING CODE 4510-26-C
At the time of this analysis, the BEA only has an aggregate GDP
growth estimate for the 4th quarter of 2020, which is 4.0 percent; that
aggregate estimate is used to bring the data to the end of 2020.\128\
While costs for the rule only occur during the time the ETS is in
effect, the amount of time that firms have to pay for those costs,
through direct revenues, loans, or other means, is not necessarily
limited to the ETS period itself. In theory, the firm could continue
paying the costs through the remaining life of the firm. Here the
agency limits the revenue used for the feasibility analysis to six
months, which extends to the end of 2021. Again, the agency uses the
aggregate GDP forecasts of the Conference Board, shown above in Table
VI.B.D.1, to estimate revenues through 2021.
---------------------------------------------------------------------------
\128\ (BEA, May 26, 2021).
---------------------------------------------------------------------------
Chaining these various datasets together, OSHA estimates final
percentage changes in employment and revenue/profits through 3rd
quarter 2021. There was a big decrease in employment, revenue, and
profits in the middle of 2020 due to the pandemic but there has since
been a rebound and GDP forecasts are somewhat positive going forward.
Of course, there is a great deal of uncertainty in forecasts at this
time, but OSHA believes it has made reasonable estimates of current and
future conditions based on public government datasets and other
substantial evidence in the record. For employment, the overall average
percentage change across all 6-digit NAICS industries from 2019 to 3rd
quarter 2021 is -2.9%. The same average for revenue is 2.5%.
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VII. Additional Requirements
A. Regulatory Flexibility Act
Whenever an agency is required by the Administrative Procedure Act,
5 U.S.C. 553, or another law, to publish a general notice of proposed
rulemaking, the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires the agency to prepare an initial regulatory flexibility
analysis (IRFA). 5 U.S.C. 601(2), 603(a). Since this ETS ``shall serve
as a proposed rule'' for a final standard under section 6(c)(3) of the
OSH Act, it is treated as a general notice of proposed rulemaking under
the RFA. An agency may waive or defer the IRFA in the event a rule is
promulgated in response to an emergency that makes compliance with the
requirements of section 603 impracticable. 5 U.S.C. 608(a). The agency
hereby certifies that compliance with the IRFA requirement is
impracticable under the circumstances. OSHA prepared this ETS on an
expedited basis in response to a national emergency affecting the lives
and health of the nation's healthcare workers; the IRFA is inherently a
relatively lengthy process that would be impracticable to undertake for
a standard of such broad applicability in the limited time available.
Because OSHA is not preparing an IRFA for the ETS, the agency is also
not required to convene a small entity panel under section 609(b).
B. Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1501 et seq.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), 2
U.S.C. 1532, requires agencies to assess the anticipated costs and
benefits of a rule before issuing ``any general notice of proposed
rulemaking'' that includes a Federal mandate that may result in
expenditures in any one year by state, local, or Tribal governments, or
by the private sector, of at least $100 million, adjusted annually for
inflation. The assessment requirement also applies to ``any final rule
for which a general notice of proposed rulemaking was published.'' The
agency has satisfied the assessment requirement in section 202 through
its analysis of the ETS's benefits and economic feasibility.
C. Executive Order 13175
Section 5 of E.O. 13175, on Consultation and Coordination with
Indian Tribal Governments, requires agencies to consult with tribal
officials early in the process of developing regulations that: (1) Have
tribal implications, that impose substantial direct compliance costs on
Indian governments, and that are not required by statute; or (2) have
tribal implications and preempt tribal law. 65 FR 67249, 67250 (Nov. 6,
2000). E.O. 13175 requires that such consultation occur to the extent
practicable. OSHA held a listening session to hear the concerns of
tribal representatives during the preparation of this ETS.
D. National Environmental Policy Act
OSHA has reviewed this ETS according to the National Environmental
Policy Act (NEPA) of 1969, 42 U.S.C. 4321 et seq., the regulations of
the Council on Environmental Quality, 40 CFR chapter V, subchapter A,
and the Department of Labor's NEPA procedures, 29 CFR part 11. The
agency has determined that the rule will have no significant impact on
air, water, or soil quality; plant or animal life; the use of land; or
other aspects of the external environment. The ETS will likely generate
some additional materials that will enter the waste stream ends at
landfills, but that amount will be marginal and is not expected to
impact current waste management practices or channels. First, OSHA's
economic analysis identifies a relatively small, temporary and fixed
increase in disposable materials. Even absent the exclusions for
ambulatory care providers that screen out COVID-19 patients, the ETS
would result in the following approximate totals of additional
disposable items: 197 million gloves, 403 million surgical masks, 15
million N-95 respirators, 108 million disposable gowns, and 15 million
disposable face shields. The personal protective equipment used for
COVID-19 related care is a small fraction of that which is used for all
other healthcare purposes. OSHA has estimated that most personal
protective equipment would increase by 10% during the 6 months the ETS
is expected to remain in effect. Moreover, the number of gloves is
insignificant when compared to aggregate number of gloves already
typically used by hospitals and other healthcare employers. For
context, hospital supply analysts recently estimated that the ``global
demand for nitrile exam gloves exceeds production capacity by about 215
billion units, or about 40 percent'' (Premier Data, April 1, 2021).
That means that roughly 86 billion gloves are already being produced to
meet existing demand, and the amount of gloves required by this
standard would be fewer than 0.2% of that number. Furthermore, based on
the agency's knowledge of the healthcare industry, OSHA believes that
it is already standard practice for the vast majority of health care
staff, if not all, to be wearing some type of face covering even if
they are not currently wearing facemasks or respirators as defined in
the ETS. The use of facemasks and N-95 respirators actually represent a
transfer of disposable products rather than an increase in overall
waste: one type of disposable product with roughly the same physical
dimensions would replace another in landfills.
Second, as acknowledged in the economic analysis for the ETS,
OSHA's estimates are significant overestimates of the actual numbers of
PPE that would be required by the ETS because they do not account for
the very significant carve-out for ambulatory healthcare settings
through which many employers will be able to avoid all of the
requirements of the ETS by screening out people with suspected or
confirmed COVID-19 and excluding them from the employer's facility (see
Sec. 1910.502(a)(2)(iii).
Finally, this ETS is expected to be in place for only six months.
By comparison, OSHA's permanent Bloodborne Pathogens standard requires
roughly the same types of disposable PPE for healthcare staff. OSHA
certified that the Bloodborne standard would not have a significant
environmental impact on the basis that the ``incremental impacts on
landfills'' resulting from the increase in the use of disposable items
required by the standard, such as personal protective equipment,
syringes, and sharps disposal containers would increase in tonnage of
``approximately 50,000 tons per year,'' which would increase the annual
solid waste generation of approximately 160 million tons per year ``by
less than 0.1% per year'' (56 FR 64088 (Dec. 6, 1991). Given that
amount of disposable PPE required by the Bloodborne standard on an
annual basis will certainly be much higher than the cumulative 6 months
of PPE necessitated by the ETS, OSHA's conclusion regarding the
environmental impact of the ETS is consistent with its previous
certification of no significant adverse environmental impact in the
Bloodborne standard.
Based on the foregoing evidence and analysis, OSHA finds that the
ETS will have no significant adverse environmental impacts.
E. Congressional Review Act
This ETS is considered a major rule under the Congressional Review
Act (CRA), 5 U.S.C. 801 et seq. Section 801(a)(3) of the CRA normally
requires a 60-day delay in the effective date of a major rule. 5 U.S.C.
801(a)(3), 804(2). However, section 808(2) of the CRA allows the
issuing agency to make a rule effective sooner than otherwise provided
by the CRA if the agency makes a good cause finding that notice and
public procedure are impracticable, unnecessary, or contrary to the
public interest. 5 U.S.C. 808(2). OSHA finds that there is good cause
to make this rule effective upon publication because notice and public
procedure with respect to this ETS are both impracticable and contrary
to the public interest, given the expedited timeline on which this
standard was developed and the grave danger threatening healthcare
workers' lives and health (see Grave Danger and Need for the ETS, both
in Section IV of this preamble). Congress authorized OSHA to take swift
action in promulgating an ETS to address this type of grave danger, and
provided explicitly that an ETS is effective upon publication, 29
U.S.C. 655(c)(1); delaying the effective date of such an expedited
process would thwart that purpose. It is specifically because of the
emergency nature of this rulemaking that the OSH Act allows for OSHA to
proceed without the extensive public input the agency normally solicits
in issuing occupational safety and health standards. 29 U.S.C.
655(c)(1). For rules to which section 808(2) applies, the agency may
set the effective date. In this case, consistent with the OSH Act
requirement cited above, the ETS takes immediate effect upon
publication in the Federal Register.
F. Administrative Procedure Act
The Administrative Procedure Act (APA) normally requires notice and
comment, and a 30-day delay of the effective date of a final rule, for
recordkeeping and reporting regulations promulgated under section 8(c)
of the OSH Act. 29 U.S.C. 657(c); 5 U.S.C. 553(b), (d). This ETS
contains recordkeeping and reporting requirements tailored to address
COVID-19 illness. To the extent that these requirements are not already
exempt from the APA's requirements for notice and comment and delay in
effective date under section 6(c) of the Act, OSHA invokes the ``good
cause'' exemption to the APA's notice requirement because the agency
finds that notice and public procedure are impracticable and contrary
to the public interest under 5 U.S.C. 553(b)(3)(B). As explained in
more detail in Grave Danger and Need for the ETS (both in Section IV of
the preamble), this finding is based on the critical importance of
implementing the requirements in this ETS, including the recordkeeping
and report provisions, as soon as possible to address the grave danger
that COVID-19 presents to healthcare workers. For the same reason, OSHA
finds good cause to waive the normal 30-day delay in the effective date
of a final rule from the date of its publication in the Federal
Register. See 5 U.S.C. 553(d)(3). As noted above, the ETS is required
by the OSH Act to take immediate effect upon publication. 29 U.S.C.
655(c)(1).
G. Consensus Standards
OSHA must consider adopting existing national consensus standard
that differ substantially from OSHA's standard if the consensus
standard would better effectuate the purposes of the Act. See section
12(d)(1) of the National Technology Transfer and Advancement Act of
1995 (15 U.S.C.A. 272 Note); see also 29 U.S.C. 655(b)(8). OSHA is not
aware of any applicable national consensus standards addressing the
grave danger posed by COVID-19 specifically. OSHA is, however,
incorporating by reference several consensus standards for face shields
and CDC guidance. See Sec. 1910.509, on incorporation by reference.
OSHA considered incorporation of ASTM F3502-21 in this ETS, as
required. However, the agency has determined that it is infeasible for
the timeframe of this ETS to incorporate this consensus standard or to
otherwise establish additional criteria for face coverings beyond that
already recommended by the CDC due to the time needed to manufacture
and distribute such a new product (see the discussion of face coverings
in the Need for Specific Provisions, which is located in Section V of
the preamble).
H. Executive Order 13045
Executive Order 13045, on Protection of Children from Environmental
Health Risks and Safety Risks, requires that Federal agencies
submitting covered regulatory actions to OIRA for review pursuant to
Executive Order 12866 must provide OIRA with (1) an evaluation of the
environmental health or safety effects that the planned regulation may
have on children, and (2) an explanation of why the planned regulation
is preferable to other potentially effective and reasonably feasible
alternatives considered by the agency (62 FR 19885 (4/23/1997)).
Executive Order 13045 defines ``covered regulatory actions'' as rules
that may (1) be economically significant under Executive Order 12866,
and (2) concern an environmental health risk or safety risk that an
agency has reason to believe may disproportionately affect children.
Because OSHA has no reason to believe that the risk from COVID-19
disproportionately affects children, the ETS is not a covered
regulatory action and OSHA is not required to provide OIRA with further
analysis under section 5 of the executive order. However, to the extent
children are exposed to COVID-19 either as employees or at home as a
result of family members' workplace exposures to COVID-19, the ETS
should decrease children's exposures to the virus.
I. Federalism
The agency reviewed this ETS according to Executive Order 13132, on
Federalism, which requires that Federal agencies, to the extent
possible, refrain from limiting State policy options, consult with
States before taking actions that would restrict States' policy
options, and take such actions only when clear constitutional authority
exists and the problem is of national scope. 64 FR 43255 (8/10/1999).
The Executive Order allows Federal agencies to preempt State law only
with the express consent of Congress. In such cases, Federal agencies
must limit preemption of State law to the extent possible.
The Occupational Safety and Health Act is an exercise of Congress's
Commerce Clause authority, and under Section 18 of the Act, 29 U.S.C.
667, Congress expressly provided that States may adopt, with Federal
approval, a plan for the development and enforcement of occupational
safety and health standards. OSHA refers to States that obtain Federal
approval for such plans as ``State Plans.'' Occupational safety and
health standards developed by State Plans must be at least as effective
in providing safe and healthful employment and places of employment as
the Federal standards. Subject to these requirements, State Plans are
free to develop and enforce their own occupational safety and health
standards.
This ETS complies with E.O. 13132. The problems addressed by this
ETS for COVID-19 are national in scope. As explained in Grave Danger
(Section IV.A. of the preamble), healthcare employees face a grave
danger from exposure to COVID-19 in the workplaces where protections
are required by this ETS. Healthcare employees across the country face
the danger of exposure to COVID-19 at
work, and as explained in Need for the ETS (Section IV.B. of the
preamble), a national standard is needed to ensure that a uniform,
baseline approach is taken to protect them. The SARS-CoV-2 virus is
highly communicable and infects workers without regard to state
borders, making a national approach necessary. Accordingly, the ETS
establishes minimum requirements for employers in every State to
protect healthcare employees from the risks of exposure to COVID-19. In
States without OSHA-approved State Plans, Congress expressly provides
for OSHA standards to preempt State occupational safety and health
standards in areas addressed by the Federal standards. In these States,
the ETS limits State policy options in the same manner as every
standard promulgated by the agency. Furthermore, nothing in the ETS is
intended to limit general public health measures instituted by state or
local governments that go beyond, and are not inconsistent with, the
requirements of the ETS. In States with OSHA-approved State Plans, this
ETS does not significantly limit State policy options. Any special
workplace problems or conditions in a State with an OSHA-approved State
Plan may be dealt with by that State's standard, provided the standard
is at least as effective as this ETS. Several State Plans have adopted
COVID-19 workplace requirements, and OSHA has consulted with them in
developing this emergency temporary standard.
J. State Plans
When Federal OSHA promulgates an emergency temporary standard,
States and U.S. Territories with their own OSHA-approved occupational
safety and health plans (``State Plans'') must either amend their
standards to be identical or ``at least as effective as'' the new
standard, or show that an existing State Plan standard covering this
area is ``at least as effective'' as the new Federal standard. 29 CFR
1953.5(b). Adoption of the ETS by State Plans must be completed within
30 days of the promulgation date of the final Federal rule, and State
Plans must notify Federal OSHA of the action they will take within 15
days. The State Plan standard must remain in effect for the duration of
the Federal ETS.
Of the 28 States and Territories with OSHA-approved State Plans, 22
cover both public and private-sector employees: Alaska, Arizona,
California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan,
Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico,
South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and
Wyoming. The remaining six States and Territories cover only state and
local government employees: Connecticut, Illinois, Maine, New Jersey,
New York, and the Virgin Islands.
This ETS imposes new requirements to protect healthcare workers
across the nation from COVID-19.
K. Paperwork Reduction Act
I. Overview
The Emergency Temporary Standard (ETS) for occupational exposure to
COVID-19 (Coronavirus Disease 2019) being published at 29 CFR part
1910, subpart U, (29 CFR 1910.502, et seq.) contains collection of
information requirements that are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA), 44 U.S.C. 3501, et seq, and OMB's regulations at 5 CFR part
1320. The PRA defines a ``collection of information'' to mean ``the
obtaining, causing to be obtained, soliciting, or requiring the
disclosure to third parties or the public, of facts or opinions by or
for an agency, regardless of form or format'' (44 U.S.C. 3502(3)(A)).
This ETS will protect healthcare employees from occupational
exposure to COVID-19. The ETS adds new Subpart U to OSHA's standards in
29 CFR part 1910. Subpart U is divided into several parts, and Sec.
1910.502 contains information collection requirements.
Under the PRA, a Federal agency cannot conduct or sponsor a
collection of information unless OMB approves it, and the agency
displays a currently valid OMB control number (44 U.S.C. 3507). Also,
notwithstanding any other provision of law, no employer shall be
subject to penalty for failing to comply with a collection of
information if the collection of information does not display a
currently valid OMB control number (44 U.S.C. 3512). The PRA has
special provisions for emergency situations applicable to the ETS.
Under 44 U.S.C. 3507(j) and OMB's implementing regulations (5 CFR
1320.13), OMB can authorize a collection of information without regard
to the normal clearance procedures if the relevant agency determines
that the collection of information ``is essential to the mission of the
agency'' and ``public harm is reasonably likely to result if normal
clearance procedures are followed'' or ``the use of normal clearance
procedures . . . is reasonably likely to cause a statutory or court
ordered deadline to be missed.'' OSHA has requested, and OMB has
authorized, the use of these emergency procedures for this ETS because
protecting the health of the healthcare employees covered by the
protections in this ETS is essential to OSHA's mission and employee
health will be harmed if this ETS is not issued in an expeditious
manner. The agency requested that OMB assign the information
collections an OMB control number for 180 days in accordance with 44
U.S.C. 3507(j)(1). On [June 11, 2021, the Department of Labor submitted
to OMB for approval an Information Collection Request (ICR) containing
a full analysis and description of the burden hours and costs
associated with the collections of information in the ETS to OMB. A
copy of the ICR is available to the public at http://www.reginfo.gov.
OSHA will publish a separate notice in the Federal Register that will
announce the results of OMB's review. That notice will also include a
final list of OMB approved collections of information and total burden
hours and costs imposed by the new standard.
The collections of information found in the ETS are listed below.
II. Summary of Information Collection Requirements
The following paragraphs provide information about this ICR.
1. Title: COVID-19 Emergency Temporary Standard (29 part CFR 1910,
subpart U).
2. Type of Review: Emergency.
3. OMB Control Number: 1218-0277.
4. Affected Public: Business or other for-profit. This rule applies
to employers in healthcare who have employees that may have
occupational exposure to COVID-19 while engaging in work activities.
5. Description of the ICR: The COVID-19 ETS contains collection of
information requirements that will assist both employers and employees
in addressing the risk of occupational exposure to COVID-19.
Specifically, OSHA has found that these requirements are necessary to
address the grave danger to healthcare employees from transmission of
the SARS-CoV-2 virus in the workplace, resulting in COVID-19 that can
be fatal. Some of the key means for preventing this transmission at the
workplace are keeping people distanced to make the potential
transmission of the virus less likely, identifying infected employees
who need to be excluded from the workplace, and recordkeeping and
information exchanges necessary to help prevent infected employees from
spreading the virus in the workplace. To be effective, these measures
require information exchanges, such as signage
to direct employees or visitors where to stand, as well as collection
of information such as whether an employee has tested positive for
COVID-19. To identify the best way to address workplace-specific
hazards, OSHA also requires employers to involve their employees in the
development of a COVID-19 plan to identify areas where physical
distancing or other controls are needed, or may be difficult, so that
the employer can implement controls or processes to better protect
employees. OSHA notes that some of these requirements may necessitate
the sharing of personal and confidential information. OSHA has tailored
its requirements to minimize these types of information exchanges, but
the agency finds that the information required to be gathered,
recorded, or shared subject to the limitations specified, are each
necessary to protect workers from a grave danger.
This information collection request for the COVID-19 ETS is
described below:
Section 1910.502--Healthcare
The COVID-19 ETS provisions for healthcare contain collection of
information requirements applicable to all healthcare workplaces where
any employee provides healthcare services or healthcare support
services. The collection of information requirements in this section
require employers to develop and implement a written COVID-19 plan,
perform health screening and medical management (including additional
requirements related to patient screening), maintain records of their
COVID-19 Plans and COVID-19 exposures and infections among their
workers, and report work-related COVID-19 hospitalizations and
fatalities to OSHA.
6. Summary of the Information Collection Requirements: Below is a
summary of the collection of information requirements identified in the
COVID-19 ETS. See Table VII.-1. Each of the provisions of the ETS
identified below, including the requirements resulting in collections
of information and the reasons the agency is requiring them, are
discussed in more detail in Section VIII. Summary and Explanation of
the ETS. OSHA's rationale for identifying the various provisions as
requiring a collection of information, as well as the impact of the
information collections, is also discussed in more detail in Item 8 of
the ICR. A copy of this ICR is available to the public at: http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0277.
[GRAPHIC] [TIFF OMITTED] TR21JN21.070
7. Number of respondents: 748,816.
8. Frequency of responses: One time; on occasion; quarterly.
9. Number of responses: 8,428,134.
10. Average time per response: Varies.
11. Estimated total burden hours: 19,260,202.
12. Estimated cost (capital-operation and maintenance):
$3,016,812.57.
III. Request for Comment
Although the ETS takes effect immediately, with implementation
dates for several provisions specified in the Dates provisions of Sec.
1910.502, it is
a temporary standard that can only be made permanent following an
opportunity for public notice and comment. OSHA therefore invites the
public to submit comments to OMB, in addition to OSHA, on the proposed
collections of information with regard to the following:
Whether the proposed collections of information are
necessary for the proper performance of the Agency's functions,
including whether the information is useful;
The accuracy of OSHA's estimate of the burden (time and
cost) of the collections of information, including the validity of the
methodology and assumptions used;
The quality, utility, and clarity of the information
collected; and
Ways to minimize the compliance burden on employers, for
example, by using automated or other technological techniques for
collecting and transmitting information.
Comments maybe be submitted to OSHA. In addition to submitting
comments directly to the agency, members of the public who wish to
comment on the agency's information collection requirements in this ETS
may send written comments to the Office of Information and Regulatory
Affairs, Attn: OMB Desk Officer for the DOL-OSHA (RIN 1218-AD36),
Office of Management and Budget, Room 10235, Washington, DC 20503. You
may also submit comments to OMB by email at:
OIRA_submission@omb.eop.gov. Please reference the ICR Reference Number
202106-1218-004 in order to help ensure proper consideration. The
agency encourages commenters also to submit their comments related to
the agency's clarification of the information collection requirements
to the rulemaking docket (Docket Number OSHA-2021-0003), along with
their comments on other parts of the proposed rule. For instructions on
submitting these comments to the rulemaking docket, see the sections of
this Federal Register notice titled DATES and ADDRESSES.
References
Premier Data. (2021, April 1). The state of PPE supply one year into
COVID-19. https://www.premierinc.com/newsroom/blog/premier-data-the-state-of-ppe-supply-one-year-in-to-covid-19. (Premier Data, April 1,
2020).
VIII. Summary and Explanation
A. Scope and Application
This ETS applies to employers in settings where any employee
provides healthcare services or healthcare support services. This
includes: Employees in hospitals, nursing homes and assisted living
facilities; emergency responders; home healthcare workers; and
employees in ambulatory care facilities. These settings are
collectively referred to as ``healthcare'' in this Summary and
Explanation.\129\
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\129\ In addition to the scope exceptions contained in the ETS
itself, which are discussed in this section, there may be situations
where the ETS does not apply by operation of the OSH Act. For
example, the ETS does not apply where states with OSHA-approved
occupational safety and health programs (``State Plans'') have
coverage (see 29 U.S.C. 667), State Plans must adopt and enforce
COVID-19 requirements that are at least as effective as the ETS.
Finally, the ETS does not apply to state and local government
employers in states without State Plans (see 29 U.S.C. 652(5)).
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The focus of the ETS is on protecting healthcare workers in
settings where suspected or confirmed COVID-19 patients are treated.
The Director of the CDC's National Institute for Occupational Health
(NIOSH) recently wrote to OSHA expressing concern that workers ``in
settings that provide treatment to patients with suspected or confirmed
COVID-19 face a particularly elevated risk of being infected with SARS-
CoV-2'' because the delivery of such care ``requires repeated instances
of close contact with infected patients'' and healthcare workers ``will
be of greater risk of exposure to new SARS-CoV-2 variants'' because
they will be among the first to be exposed to people carrying the
variants as they emerge and those infected seek medical care (Howard,
May 22, 2021). OSHA does not distinguish between healthcare services
provided outdoors from those same services provided indoors. For
example, the risks to an emergency medical technician who provides
mouth-to-mouth resuscitation to a patient are the same whether the care
is provided outdoors or indoors. Additionally, while the CDC has stated
that the risk of transmission outdoors is low for general activities,
that guidance specifically states that it ``applies in non-healthcare
settings'' (CDC, May 13, 2021).
The heightened risk for healthcare workers is discussed in more
detail in the Grave Danger section.
This standard also addresses the heightened risk faced by employees
of long-term care facilities where the congregate living situation and
weakened immune systems of many of the residents can lead infections
such as COVID-19 to spread rapidly between patients or residents and
then to the healthcare staff who care for them. Like employees who work
at hospitals, clinics, and other healthcare facilities, employees who
work at long-term care facilities include both healthcare
practitioners, who may have direct and close contact with patients and
residents, as well as healthcare support staff who could also be
exposed directly to patients and residents, or indirectly through
aerosols that can remain suspended in rooms for various periods of time
or settle and contaminate surfaces. If the presence of COVID-19
patients does lead to more infection of those providing direct
healthcare services, those infected workers can then spread the virus
to healthcare support personnel who have not yet been vaccinated to
prevent that. Medical examiners and support personnel face similar
danger in settings where autopsies are performed on suspected or
confirmed COVID-19 victims, particularly where aerosol generating
procedures are employed. These heightened risks are also discussed
further in the grave danger section.
Thus, the standard targets healthcare settings where OSHA has found
the elevated risk associated with care of persons with confirmed and
suspected COVID-19, and associated activities, constitute a grave
danger. Accordingly, it exempts out settings where this elevated risk
does not exist. This does not mean there is not a significant risk of
COVID-19 infection in the settings exempted from this standard, and the
OSH Act's general duty clause may require employers to take steps to
protect employees even in settings where an exception applies.
OSHA recognizes that the grave danger is most elevated in those
healthcare settings where people with suspected or confirmed COVID-19
are expected to be treated, but it also acknowledges that there is a
subset of healthcare providers who elect not to treat such people and
instead screen them out to prevent them from entering their facilities.
Paragraph (a)(2) of the ETS therefore includes several scope exclusions
for such employers, which are addressed in more detail in the following
summary and explanation. This is not the only exception--several other
exceptions are identified and explained in the following paragraphs--
but focusing the ETS on settings where COVID-19 is reasonably expected
to be present is particularly significant because it is intended to
tailor the ETS to address the grave danger OSHA has identified and the
need for the ETS to address that danger.
Paragraph (a)(1) provides that the ETS applies to all settings
where any employee provides healthcare services or performs healthcare
support services except as otherwise provided later in paragraph (a).
It is important to note that, for the most part, the ETS is
settings-based; that is, if any employee in any setting performs one of
the tasks enumerated in paragraph (a)(1), each employer with employees
in that setting must (except as otherwise provided in paragraph (a))
follow the ETS, even though some of these employees might not engage in
the enumerated tasks. Thus, for example, the ETS would generally apply
to protect all employees in a hospital (e.g., employees working in the
cafeteria, employees performing administrative tasks in the hospital),
not just those employees providing healthcare services or performing
healthcare support services (e.g., housekeeping). OSHA takes a
settings-based approach in the ETS, rather than a task-based approach,
to ensure that the ETS is consistent with the CDC's COVID-19 guidance,
which also takes a settings-based approach that most healthcare
employers are accustomed to, and to protect all employees in these
high-risk settings from the hazard of COVID-19, which can be spread
from the direct patient care areas to other areas through a variety of
personnel interactions and exposures.
The term ``setting'' can encompass several types of scenarios. On
the one hand, if a service is performed in a facility whose primary
function is the provision of healthcare services (such as a hospital,
urgent care facility, or outpatient clinic), all areas in the facility
would be considered part of the same setting. For example, a pharmacy
or optical department in a hospital would be considered part of the
hospital setting. On the other hand, an embedded healthcare clinic in a
prison, manufacturing facility, or school would be treated as a
healthcare setting that is separate from the remainder of the prison,
manufacturing facility, or school (i.e., the non-healthcare setting).
In the case of mobile healthcare services, where licensed
healthcare providers enter a non-healthcare setting to provide services
(e.g., emergency response or home healthcare), this ETS applies only to
the provision of the healthcare services (i.e., the measures necessary
to ensure safe work practices for the work tasks that the employees
providing the healthcare services are expected to perform) and not to
the entire setting itself. For example, if a nurse provides in-home
healthcare while a cleaning person happens to be working separately in
the house, the ETS applies to the nurse but would not apply to the
cleaning person. OSHA does not intend the ETS to apply generally to
non-healthcare settings even though mobile healthcare services may be
required. For further discussion of this issue, please see discussion
of paragraph (a)(3)(ii), below.
Healthcare services are defined in paragraph (b) as services that
are provided to individuals by professional healthcare practitioners,
who generally have either licensure or credentialing requirements
(e.g., doctors, nurses, emergency medical personnel, oral health
professionals) for the purpose of promoting, maintaining, monitoring,
or restoring health. Healthcare services are delivered through various
means including: Hospitalization, long-term care, ambulatory care
(e.g., treatment in physicians' offices, dentists' offices, and medical
clinics), home health and hospice care, emergency medical response, and
patient transport. For the purposes of this ETS, healthcare services
include autopsies, which are typically performed by licensed medical
examiners. As discussed earlier, while healthcare services are provided
in healthcare settings (e.g., hospitals, ambulatory care facilities,
such as dentists' offices and doctors' offices, ambulatory surgical
centers, medical clinics embedded in schools, correctional facilities,
and industrial settings, ambulances, long-term care facilities, such as
nursing homes and skilled nursing facilities, urgent care centers),
they are also provided in non-healthcare settings (e.g., EMT treating a
patient at the site of an accident).
Healthcare support services is defined in paragraph (b) to mean
services that facilitate the provision of healthcare services.
Healthcare support services include patient intake/admission, patient
food services, equipment and facility maintenance, housekeeping
services, healthcare laundry services, medical waste handling services,
and medical equipment cleaning/reprocessing services. Moreover,
healthcare support services can occur both in healthcare settings and
in other settings, although the ETS does not apply to healthcare
support services not performed in a healthcare setting. For further
discussion of this issue, please see discussion of paragraph (a)(2)(vi)
below.
Paragraph (a)(2) serves to limit the applicability of the ETS and
provides that the ETS does not apply to the following: (i) The
provision of first aid by an employee who is not a licensed healthcare
provider; (ii) the dispensing of prescriptions by pharmacists in retail
settings; (iii) non-hospital ambulatory care settings where all non-
employees are screened prior to entry and people with suspected or
confirmed COVID-19 are not permitted to enter those settings; (iv)
well-defined hospital ambulatory care settings where all employees are
fully vaccinated and all non-employees are screened prior to entry and
people with suspected or confirmed COVID-19 are not permitted to enter
those settings; (v) home healthcare settings where all employees are
fully vaccinated and all non-employees are screened prior to entry and
people with suspected or confirmed COVID-19 are not present; (vi)
healthcare support services not performed in a healthcare setting
(e.g., off-site laundry, off-site medical billing); or (vii) telehealth
services performed outside of a setting where direct patient care
occurs.
Per paragraph (a)(2)(i), the ETS does not apply to the provision of
first aid by an employee who is not a licensed healthcare provider.
First aid typically refers to medical attention that is usually
administered immediately after an injury occurs and at the location
where it occurred. It often consists of a one-time, short-term
treatment and requires relatively little technology or training to
administer. First aid may include cleaning minor cuts, scrapes, or
scratches; treating a minor burn; applying bandages and dressings; the
use of non-prescription medicine; draining blisters; removing debris
from the eyes; massage; and drinking fluids to relieve heat stress.
First aid may also include cardiopulmonary resuscitation (which
includes chest compressions, rescue breathing, and, as appropriate,
other heart and lung resuscitation techniques) of a sick or injured
person until medical treatment by a licensed healthcare provider can be
administered.
The ``first aid'' exception to the ETS applies regardless of
setting. Thus, for example, if an employee who is not a licensed
healthcare provider is expected to administer first aid as part of
their job duties in an industrial facility, the ETS does not apply even
if first aid is provided to a person who develops COVID-19 symptoms
while on the job. OSHA included this exemption to make clear that this
ETS does not impose extra healthcare-related requirements for employees
who are not licensed healthcare providers when they provide first aid.
However, first aid provided by licensed healthcare providers (e.g., a
nurse or emergency responder) is covered by this ETS.
The ETS is aimed at protecting employees facing those COVID-19
hazards that constitute a grave danger. To this end, the scope
exemptions in paragraphs (a)(2)(ii) through (a)(2)(vii) narrowly tailor
the ETS to those settings where there is a reasonable expectation that
persons with suspected or confirmed COVID-19 will be present.
Paragraph (a)(2)(ii) exempts the dispensing of prescriptions by
pharmacists in retail settings (e.g., pharmacies in grocery stores).
Treatment or testing of COVID-19 patients would not be expected there.
This is a situation where employees dispense medications in a setting
and in a manner that is more similar to that of other retail employees
dispensing other goods in retail establishments. OSHA emphasizes that
the exception for the dispensing of prescriptions by pharmacists in
retail settings does not apply when this activity is performed in
healthcare settings such as hospitals or ambulatory care clinics. Such
pharmacists are covered by the ETS because they are located in settings
where treatment of people with suspected or confirmed COVID-19 is more
likely to occur.
It is important to note that the ``retail pharmacist'' exception
applies only to the dispensing of prescriptions and not to other
healthcare services that a pharmacist might provide (e.g., vaccination,
testing). Moreover, OSHA will not consider the setting in which
prescriptions are dispensed to be a retail setting if other healthcare
services are performed in the same setting as the dispensing of
prescriptions. Thus, for example, if a pharmacist performs COVID-19
testing in the same setting where they dispense prescriptions, OSHA
will consider that setting to be a healthcare setting and not a retail
setting. In such cases, the employer will have a reasonable expectation
that persons with suspected or confirmed COVID-19 will be present.
Paragraphs (a)(2)(iii) and (a)(2)(iv) provide exemptions from the
ETS for certain ambulatory care settings. As defined in paragraph (b),
ambulatory care means healthcare services performed on an outpatient
basis, without admission to a hospital or other facility. It is
provided in settings such as: Offices of physicians and other
healthcare professionals; hospital outpatient departments; ambulatory
surgical centers; specialty clinics or centers (e.g., dialysis,
infusion, medical imaging); and urgent care clinics. Ambulatory care
does not include home healthcare settings for the purposes of this ETS.
Paragraph (a)(2)(iii) provides that the ETS does not apply to non-
hospital ambulatory care settings where all non-employees are screened
prior to entry and people with suspected or confirmed COVID-19 are not
permitted to enter those settings. This exception is intended to
exclude from the standard certain healthcare providers that do not
treat, and instead exclude from their facilities, people with suspected
or confirmed COVID-19, either because such treatment is not related to
the nature of their practice or because the provider chooses not to
engage in such treatment as a matter of policy. The exception will
apply so long as the employer meets the exception's conditions: The
employer must screen each non-employee prior to entry, make a
determination based on that screen whether the non-employee has
suspected or confirmed COVID-19, and bar entry to that non-employee if
it is determined that the non-employee has suspected or confirmed
COVID-19.
Under paragraph (b), a person with confirmed COVID-19 (or a COVID-
19 positive person) is one who has a confirmed positive test for, or
who has been diagnosed by a licensed healthcare provider with, COVID-
19. Examples of persons with suspected COVID-19 are those who indicate
(during a COVID-19 screening, for example) that they have symptoms of
COVID-19, or who present at a healthcare facility to receive a COVID-19
test. Per paragraph (b), COVID-19 symptoms mean the following: Fever or
chills; cough; shortness of breath or difficulty breathing; fatigue;
muscle or body aches; headache; new loss of taste or smell; sore
throat; congestion or runny nose; nausea or vomiting; diarrhea. As will
be discussed below, under the ETS, employers must have systems and
processes in place to allow them to ascertain whether persons have
suspected or confirmed COVID-19. OSHA has not attempted to define the
term ``suspected COVID-19'' further because it expects that most
employers in healthcare settings will have the capability to identify
individuals suspected of health ailments. For example, health care
employers should suspect that a person may have COVID-19 if the person
indicates that they have COVID-19 symptoms or if they disclose that
they are getting tested because of a close contact with a person who
has COVID-19. Outside of routine or otherwise mandated COVID-19
testing, a person who is taking a COVID-19 test should generally be
treated as suspected to have COVID-19 until the results of the test are
known.
Paragraph (b) also specifies that screen means asking questions to
determine whether a person is COVID-19 positive or has symptoms of
COVID-19. OSHA notes that screening can typically be accomplished
through questioning. However, employers may choose to employ other
methods in addition to the required questions, such as temperature
checks, in the conduct of screening. Screening may also include
confirming that individuals are abiding by the employer's policies and
procedures for wearing face coverings and assessing the individual's
recent exposure to COVID-19.
Screening may take several forms depending on the design and size
of the facility. For example, at each entrance there may need to be an
employee present to perform a health screening on each individual
entering the facility. In most cases, OSHA expects that facilities will
screen patients by calling them prior to their scheduled appointment to
ask the required screening questions. In some cases, the facility may
permit non-employees to enter momentarily for in-person screening by an
employee who performs the screening while maintaining a distance of 6
feet.
To meet this exception, the employer must not only screen patients
and family members or others accompanying patients to their
appointments, but also every non-employee who seeks to enter the non-
hospital ambulatory care setting. In this context, ``non-employee''
means any person who is not an employee of the employer who owns or
controls the setting. This would include, for example, contractors who
enter the setting to perform work (e.g., work on the HVAC system).
Examples of when the exclusion provided under paragraph (a)(2)(iii)
would apply could be in a podiatrist office, an optometrist's office,
or an oral healthcare setting (e.g., dentistry, orthodontics), if the
employer develops and implements policies and procedures to screen all
non-employees prior to entry and does not permit those with suspected
or confirmed COVID-19 entry into the facility. The employer could state
that the office will not treat, and will reschedule appointments for,
any patients who are experiencing symptoms of COVID-19 or are COVID-19
positive. This would exclude them from this ETS. If, however, the
employer continues to see patients with suspected or confirmed COVID-
19, the employer must comply with the provisions of this ETS.
Per paragraph (a)(2)(iv), this ETS does not apply to well-defined
hospital ambulatory care settings where all employees are fully
vaccinated and all non-employees are screened prior to entry and people
with suspected or confirmed COVID-19 are not permitted to enter those
settings. This is essentially the same exception as for ambulatory care
settings outside the hospital except there are two extra layers of
employee protection for when the ambulatory care setting is inside a
hospital: The area must be well-defined such that it distinct from the
rest of the
hospital (may have a separate entrance, etc.)--for example, radiology
departments, dialysis centers, or laboratories; and all of the
employees in that area must be fully vaccinated (as defined in
paragraph (b), fully vaccinated means 2 weeks or more following the
final dose of a COVID-19 vaccine). This exception recognizes that there
are likely to be patients suspected or confirmed to have COVID-19 in
some portions of the hospital and the need to prevent mixing between
areas with COVID-related care and those well-defined areas that are
expected to be free of COVID-19. The requirement to have all employees
fully vaccinated provides employees with an additional protection
against the increased chance that they might nonetheless be exposed to
suspected or confirmed COVID-19 patients, given the hospital setting.
OSHA notes that though the exception in paragraph (a)(2)(iv) might
apply to employees while they are in a well-defined hospital ambulatory
care setting, the exception is setting-based and does not travel with
that employee. Thus, for example, the exception would not apply when a
fully vaccinated employee enters the hospital, before they enter the
well-defined ambulatory care setting, or when they have lunch in a
cafeteria that is open to all employees, or go to a bathroom outside of
the well-defined area.
Under paragraph (a)(2)(v), the ETS does not apply in home
healthcare settings where all employees are fully vaccinated and all
non-employees are screened prior to the employees' entry into a
patient's home and people with suspected or confirmed COVID-19 are not
present in that home. To meet the conditions of the exception,
employers will need to screen patients and any other non-employees who
will be present in the household during the home visit (e.g., other
family members, friends, contractors, HVAC technicians, etc.) before
the employees enter that setting. If the employer does not make
reasonable efforts to ensure that all non-employees present in the
household have been screened, the exemption would not apply. OSHA
recognizes, however, that because these employers do not control the
settings where home healthcare will be provided, there is also a
reduced ability to screen all people in the location. Additionally,
many home healthcare employees' duties require extended exposure and
greater involvement in more intimate direct patient care tasks (e.g.,
bathing, toileting, feeding) that are performed in the breathing zone
of the patient and likely to result in higher exposures. To address
this and provide an additional layer of controls to ensure that
employees are protected in these settings, the employer must ensure
that all employees are fully vaccinated before they enter the home
healthcare setting to meet the exception in paragraph (a)(2)(v).
Because the employer must ensure that people with suspected or
confirmed COVID-19 are not present during the home visit to fall within
the exception, the employer must specify a clear contingency for
situations where an employee arrives at the home healthcare setting and
finds an unexpected non-employee in the setting: That non-employee must
be screened, the employee must leave that home, or the employer may
allow the employee to continue at the home provided that the employer
complies with all requirements of the ETS.
OSHA notes that a momentary entry by an unvaccinated employee (or
employee whose vaccination status is not known)--delivering mail or
picking up blood samples taken by a nurse during a home visit--would
not disqualify the employer from the exceptions in paragraphs
(a)(2)(iv) or (a)(2)(v). However, if the unvaccinated employee stays
and conducts other activities in the setting that extend beyond
momentary entry, then the workplace would not qualify as ``fully
vaccinated'' and the ETS protections would be required during all
periods where the employee remains in the setting.
OSHA notes also that an employer seeking to fall under one of the
exceptions in paragraphs (a)(2)(iii), (a)(2)(iv), or (a)(2)(v) must be
able to demonstrate that it conducts screenings and excludes non-
employees with suspected or confirmed COVID-19 in order to be eligible
for the exemptions, as well as that it has determined employees'
vaccination status (if applicable).
With regards to determining employees' vaccination status, there
are a number of ways employers could approach this. For example, small
employers may know that all employees are already vaccinated because it
was a topic of conversation as people became eligible and received the
vaccine. Other employers may have required employees to be vaccinated
and will have records of vaccinations because they or their agents, as
permitted under other laws, administered a vaccine. Still others could,
when otherwise not prohibited by law, ask employees to either provide
documentation of, or attest to, their vaccination status. If an
employer is unable to determine the vaccination status of an employee,
the employer would need to comply with the ETS as though the employee
is not vaccinated.
OSHA also notes that, if a setting meets an exception in paragraphs
(a)(2)(iii), (a)(2)(iv) or (a)(2)(v), the momentary entry by a non-
employee (for example, a delivery person) would not render the ETS
applicable to the setting even though the non-employee is not screened
prior to entry. For example, if a delivery person were not screened
prior to entering the setting, this would not trigger application of
the ETS if the delivery person placed the delivery in the entryway or
the setting and then immediately left. However, if the delivery person
intends to stay and conduct other activities in the setting that extend
beyond momentary entry, to continue to fall within the relevant
exception, the employer would need to screen the delivery person prior
to entry and not permit the delivery person to enter the setting if
they had suspected or confirmed COVID-19.
A note to paragraphs (a)(2)(iv) and (a)(2)(v) provides that OSHA
does not intend to preclude the employers from the scope exemption in
paragraphs (a)(2)(iv) and (a)(2)(v) solely because they have employees
who are unable to be vaccinated. OSHA expects that one benefit of these
exceptions will be that more employers will encourage all of their
employees to be vaccinated. However, OSHA also recognizes that some
workers may not be able to be vaccinated because of either medical
conditions, such as allergies to vaccine ingredients, or certain
religious beliefs. OSHA has determined that it is not appropriate to
preclude the employers of workers who are unable to be vaccinated from
any possibility of falling within the exception. Under various anti-
discrimination laws, these workers are entitled to ask for a reasonable
accommodation from their employer. Employers of workers who are
eligible for a reasonable accommodation under disability or other civil
rights laws may therefore take advantage of the exemption if, and only
if, they provide workers who are unable to be vaccinated with a
reasonable accommodation, absent undue hardship, that prevents the
worker from being exposed to COVID-19.\130\
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\130\ Note that OSHA is not stating that unvaccinated workers
are entitled, as an accommodation, to access to the carve-out area
on a sustained basis. The accommodation must be arranged with the
employer in accordance with applicable law. OSHA's intent is simply
to provide the employer with an option to avail itself of the
exception if the employer wishes to do so and satisfies the
conditions.
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This scope exception only applies in a well-defined hospital
ambulatory care or home healthcare settings where all employees are
fully vaccinated, and only allows for reasonable accommodations, absent
undue hardship, for workers who are unable to be vaccinated for the
reasons described above. And the reasonable accommodation must ensure
the accommodated worker is not exposed to the COVID-19 hazard. OSHA is
not setting forth specific reasonable accommodations that an employer
must utilize, but only requiring that the accommodated worker not be
exposed to COVID-19 hazards. OSHA encourages employers to utilize the
Department of Labor's Office of Disability Employment Services Job
Accommodation Network (askjan.org) for assistance in helping identify
appropriate accommodations.
Paragraph (a)(2)(vi) provides that the ETS does not apply to
healthcare support services not performed in a healthcare setting
(e.g., off-site laundry, off-site medical billing), and paragraph
(a)(2)(vii) provides that the ETS does not apply to telehealth services
performed outside of a setting where direct patient care occurs. The
purpose of these exceptions, like other exceptions discussed, is to
narrowly tailor the ETS to those settings where there is a reasonable
expectation that persons with suspected or confirmed COVID-19 will be
present.
Healthcare support services, such as laundering hospital linens,
gowns, and scrubs, medical waste handling, and medical equipment
maintenance and reprocessing, are often performed in healthcare
settings. For example, a laundry facility may be located in the
basement of a hospital. The ETS applies to the provision of these
healthcare support services (and all other work) when performed in
healthcare settings (unless an exception to the standard applies) for
the reasons explained earlier regarding OSHA's decision to take a
settings-based approach to regulation.
However, when healthcare support services such as medical billing
or other administrative activities, or laundering services, are
performed in an off-site office building that does not otherwise
qualify as a healthcare setting, the ETS does not apply in these off-
site facilities.
Some healthcare services are delivered remotely (i.e., telehealth
services). Telehealth services might be delivered from within a setting
where direct patient care occurs (such as a nurse providing telehealth
services from a doctor's office in a hospital or ambulatory care clinic
where patients are also seen in person). In these cases, the ETS
applies (absent another exception). The ETS does not, however, cover
telehealth services delivered from settings where no direct patient
care occurs (such as an employee's home or a suite in an office
building where no direct patient care occurs). In these cases, the
exception in paragraph (a)(2)(vii) applies. It should be noted that,
under paragraph (b), direct patient care means hands-on, face-to-face
contact with patients for the purpose of diagnosis, treatment, and
monitoring.
Paragraph (a)(3)(i) provides that, where a healthcare setting is
embedded within a non-healthcare setting (e.g., nurse's office in a
school, medical clinic in a manufacturing facility or prison, walk-in
clinic in a retail setting such as a grocery store, physician's office
or dentist's office embedded in an office building), the ETS applies
only to the embedded healthcare setting and not to the remainder of the
physical location. OSHA notes that each medical, dental, or similar
practice embedded in an office building would be a separate healthcare
setting from the other medical, dental, or similar practices in the
office building, even if all tenants in the office building are
medical, dental, or similar practices.
Paragraph (a)(3)(ii) provides that, where emergency responders or
other licensed healthcare providers enter a non-healthcare setting to
provide healthcare services, the ETS applies only to the provision of
the healthcare services by that employee. In this limited situation,
the ETS applies to healthcare services provided by employee(s) in a
setting. This provision would apply, for example, where a physician
assigned to work in an embedded clinic or an emergency medical
responder enters the floor of a manufacturing plant or the residential
area of a prison to provide healthcare services to a sick employee or
sick prisoner. In such circumstances, the ETS would apply to the
provision of healthcare services by the physician or emergency
responder, but would not apply to all other employees in the setting.
For example, the ETS would not apply to plant workers or prison guards
who remain on the manufacturing plant floor or in the prison
residential area while the physician provides healthcare services to
the sick employee or prisoner. The requirements of the ETS that are
location-based would not apply to the provision of healthcare services
in this situation (e.g., ventilation outside of the embedded clinic,
barriers).
Paragraph (a)(4) of the ETS is a limited exception applicable to
vaccinated employees in certain situations. That paragraph provides
that the ETS's requirements for PPE (paragraph (f)), physical
distancing (paragraph (h)), and physical barriers (paragraph (i)) do
not apply to employees who are fully vaccinated when they are in well-
defined areas of a workplace where there is no reasonable expectation
that any person with suspected or confirmed COVID-19 will be present.
The requirements in the ETS for PPE, physical distancing, and physical
barriers are designed to both protect employees on an individual basis
from the COVID-19 hazard and reduce the risk that an individual
employee will transmit the virus to others. Thus, for example, the
requirement in paragraph (f) that the employer provide and ensure that
each employee wears facemasks in certain situations serves to protect
other employees from the COVID-19 hazard because facemasks act as a
source control in addition to providing some protection for the wearer
against COVID-19 transmission.
Although the exception goes beyond the CDC guidance allowing
vaccinated healthcare workers to go without masks, distancing, or
barriers only when in a space entirely populated by vaccinated workers,
OSHA is incorporating the exemption in paragraph (a)(4) into the ETS
because, as is further discussed in Grave Danger (Section IV.A of this
preamble), the Centers for Disease Control and Prevention (CDC) has
acknowledged a growing body of studies indicating that there is
significantly lowered risk of transmission of COVID-19 from vaccinated
persons to unvaccinated persons (CDC, May, 13, 2021).
Examples of well-defined areas of a workplace for the purpose of
this ETS are billing or other administrative offices, employee break
rooms, or employee meeting areas. In any of these well-defined area,
there is typically no reasonable expectation that any person with
suspected or confirmed COVID-19 will be present. As noted in the
summary and explanation of the COVID-19 plan required under paragraph
(c)(4), in order to avail themselves of this vaccinated-employee
exception, employers must assess their workplaces to determine where
the applicable well-defined areas exist and must have a process for
determining which employees are vaccinated.
It should be noted that this exemption will never apply to areas of
healthcare facilities (well-defined or not) where there is a reasonable
expectation that persons with suspected or confirmed COVID-19 may be
present, such as in emergency rooms, or patient waiting
areas or hospital wards open to treating COVID-19 patients. In such
areas, paragraphs (f), (h), and (i) of the ETS will apply to all
employees, including those employees who are fully vaccinated.
Note 1 to paragraph (a) indicates that state or local government
mandates or guidance (e.g., legislative action, executive order, health
department order) that go beyond and are not inconsistent with the ETS
are not intended to be limited by this ETS. OSHA recognizes that many
states have taken action to protect employees with mandatory
requirements that may not be appropriate for an ETS on a national
level, and that states have additional powers that OSHA does not (e.g.,
criminal sanctions). OSHA does not intend to preempt these powers or
requirements. For example, OSHA does not intend to preempt state or
local requirements for customers to wear face coverings whenever they
enter a hospital or other health care facility, or in public places
generally.
Note 2 to paragraph (a) encourages employers to follow public
health guidance from the CDC even when not required by the ETS. This
would include following CDC guidance for healthcare settings even where
employees are fully vaccinated.
References
Centers for Disease Control and Prevention (CDC). (2021, March 23).
Ventilation in Buildings. https://www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html. (CDC, March 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
Interim Public Health Recommendations for Fully Vaccinated People.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html. (CDC, May 13, 2021).
Howard, J. (2021, May 22). ``Response to request for an assessment
by the National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services, of the current hazards facing healthcare
workers from Coronavirus Disease-2019 (COVID-19).'' (Howard, May 22,
2021).
B. COVID-19 Plan
Paragraph (c) includes provisions for the development and
implementation of a COVID-19 plan, as well as requirements regarding
what needs to be in the plan. The development of a COVID-19 plan,
including comprehensive policies and procedures, is required in order
to prevent or minimize employee exposure to COVID-19 in the workplace.
All of the requirements in paragraph (c) must be included in the
employer's COVID-19 plan.
Paragraph (c)(1) requires employers to develop and implement a
COVID-19 plan for each workplace. As defined in paragraph (b), a
workplace is a physical location (e.g., fixed, mobile) where the
employer's work or operations are performed. Physical location is also
defined in paragraph (b). It means a site (including outdoor and indoor
areas, a structure or a group of structures) or an area within a site
where work or any work-related activity occurs (e.g., taking breaks,
going to the restroom, eating, entering or exiting work). A physical
location includes the entirety of any space associated with the site
(e.g., workstations, hallways, stairwells, breakrooms, bathrooms,
elevators) and any other space that an employee might occupy in
arriving, working, or leaving. As explained in paragraph (c)(1), if an
employer has multiple workplaces that are substantially similar, its
COVID-19 plan may be developed by workplace type rather than by
individual workplace so long as any site-specific information is
included in the plan. For example, if an employer has developed a
corporate COVID-19 plan that includes information about job tasks or
exposure scenarios that apply in multiple workplaces, this information
can be used in the development of COVID-19 plans for individual
workplaces.
In general, paragraphs (c)(2) through (c)(6) describe the process
by which the COVID-19 plan must be developed and implemented, and
paragraph (c)(7) lists policies and procedures that must be included in
the COVID-19 plan. However, the COVID-19 plan is adaptable to the
physical characteristics of the workplace and the job tasks performed
by employees, as well as the hazards identified by the employer when
designing their COVID-19 plan. As explained in a note to paragraph (c),
employers may also include other policies, procedures, or information
necessary to comply with any applicable federal, state, or local public
health laws, standards, and guidelines in their COVID-19 plans.
Under paragraph (c)(2), an employer with more than 10 employees is
required to develop and implement a written COVID-19 plan. While OSHA
has concluded that a COVID-19 plan is necessary for all employers
covered by the ETS, OSHA has determined that only employers with more
than 10 employees need to have a written plan. This cutoff of 10
employees is consistent with OSHA's employer size cutoff for both the
COVID-19 log requirement in this ETS and in the partial exemption from
recordkeeping requirements in 29 CFR 1904.1. In the case of employers
with 10 or fewer employees, the agency does not believe that there is a
high likelihood of misunderstanding when employers communicate their
COVID-19 plans to employees verbally. As a result, OSHA does not
believe the added burden on small employers of establishing a written
plan is necessary, particularly given the need for rapid implementation
of the ETS. However, small employers may opt to create written COVID-19
plans if they find doing so is helpful in developing and implementing
their COVID-19 plans.
In contrast, the agency is concerned that when employers have more
than 10 employees there is likely sufficient complexity in the
employer's operation that putting the COVID-19 plan in writing is
necessary to establish clear expectations and prevent miscommunication.
For example, employers with more than 10 employees may have employees
working in multiple locations or on multiple shifts, increasing the
likelihood that verbally communicating the employer's COVID-19 plan
will be ineffective. Therefore, OSHA believes that having a written
COVID-19 plan that employees of larger employers can easily access is
essential to ensure those employees are informed about policies,
programs, and protections implemented by their employers to protect
them from COVID-19-associated hazards. This approach is consistent with
OSHA's practice of allowing employers with 10 or fewer employees to
communicate their emergency action plans (29 CFR 1910.38) and fire
prevention plans (29 CFR 1910.39) orally to employees.
An employer may have already developed and implemented a COVID-19
plan to protect employees from exposure to COVID-19. Existing COVID-19
plans may fulfill some of the requirements in this section. It is not
OSHA's intent for employers to duplicate current effective COVID-19
plans, but each employer with a current COVID-19 plan must evaluate
that plan for completeness to ensure it satisfies all of the
requirements of this section. Employers with existing plans must modify
and/or update their current COVID-19 plans to incorporate any missing
required elements, and provide training on these new updates or
modifications to all employees. Employers with more than 10 employees
must ensure their existing COVID-19 plan is in writing.
For those employers who do not already have a COVID-19 plan in
place, OSHA will be releasing significant
compliance assistance materials, including a model healthcare-specific
plan to accompany the standard, which will significantly streamline
this step for many businesses. In addition, the Centers for Disease
Control and Prevention (CDC) has developed Guidance for Businesses and
Employers Responding to Coronavirus Disease 2019 (CDC, March 8, 2021)
and Healthcare Facilities: Managing Operations During the COVID-19
Pandemic (CDC, March 17, 2021), that may be helpful to employers in
developing a plan. OSHA has also published key resources for all
businesses, including Protecting Workers: Guidance on Mitigating and
Preventing the Spread of COVID-19 in the Workplace (OSHA, January 29,
2021), Guidance on Returning to Work (OSHA, June 18, 2020) and Guidance
on Preparing Workplaces for COVID-19 (OSHA, March 9, 2020).\131\ (OSHA
and the U.S. Department of Health and Human Services developed the
latter jointly.) The Guidance on Preparing Workplaces for COVID-19
document is based on traditional infection prevention and industrial
hygiene practices, and is meant to help employers and employees
identify risk levels in workplace settings and determine appropriate
control measures to implement. The Guidance on Returning to Work
document complements Guidance on Preparing Workplaces for COVID-19 and
focuses on the need for employers to develop and implement strategies
for hand hygiene, cleaning and disinfection of high-touch surfaces,
physical distancing, identification and isolation of sick employees,
workplace controls and flexibilities, and employee training. The
Protecting Workers: Guidance on Mitigating and Preventing the Spread of
COVID-19 in the Workplace document is intended to help employers and
workers implement a coronavirus prevention program, with several
essential elements, and better identify risks which could lead to
exposure and contraction.
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\131\ OSHA's Guidance on Returning to Work (OSHA, June 18,
2020), Guidance on Preparing Workplaces for COVID-19 (OSHA, March 9,
2020), and Protecting Workers: Guidance on Mitigating and Preventing
the Spread of COVID-19 in the Workplace (OSHA, January 29, 2021)
have now been archived. However, the information in these documents
can still be a useful resource for employers as they develop or re-
evaluate their COVID-19 plans.
---------------------------------------------------------------------------
Additionally, the U.S. Equal Employment Opportunity Commission
(EEOC) has developed guidance regarding What You Should Know About
COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws (EEOC,
May 28, 2021). Employers are encouraged to review this guidance as they
develop their COVID-19 plan, including policies and procedures for
health screenings, as well as return to work plans. Additional
information about labor, disability, and employment laws is available
on the Summary of the Major Laws of the Department of Labor web page
(DOL, 2020).
Paragraph (c)(3) requires the employer to designate one or more
workplace COVID-19 safety coordinators to implement and monitor the
COVID-19 plan. In order to perform these tasks effectively, the safety
coordinator(s) should be able to understand and identify COVID-19
hazards in the workplace. The COVID-19 safety coordinator(s) must be
knowledgeable in infection control principles and practices as they
apply to the workplace and employee job operations. For example, safety
coordinator(s) must be knowledgeable about the CDC's infection control
recommendations, as well as employer policies and procedures
implemented in accordance with the same (e.g., the patient screening
and management strategies implemented pursuant to paragraph (d)(3)).
Additionally, the safety coordinator(s) must have the authority to
ensure compliance with all aspects of the COVID-19 plan so that they
can take prompt corrective measures when hazards are identified. For
employers with more than 10 employees, the name of the safety
coordinator(s) must be documented in the written COVID-19 plan.
Employers must designate a safety coordinator(s) to implement and
monitor the COVID-19 plan, but the exact responsibilities of a safety
coordinator(s) may vary based on the employer and workplace. Possible
safety coordinator responsibilities may include conducting inspections
of the workplace. Regular inspections would provide a mechanism for
safety coordinator(s) to ensure the COVID-19 plan is being implemented
appropriately and to monitor the ongoing effectiveness of the plan.
During inspections, the safety coordinator(s) could observe employees
to ensure they are physically distancing and using appropriate PPE. At
places like reception or triage counters, where employees would have
encounters with members of the public, the safety coordinator(s) could
conduct inspections to ensure that there are appropriately-sized
physical barriers installed between employees and visitors. If an
employer relies on its safety coordinator to monitor compliance with
the requirements of its COVID-19 plan and this ETS, it must provide the
safety coordinator with adequate training on how to discharge those
duties.
Paragraph (c)(4)(i) requires the employer to conduct a workplace-
specific hazard assessment to identify potential workplace hazards
related to COVID-19. The hazard assessment process is intended to help
employers identify and understand where COVID-19 hazards potentially
exist and what controls must be implemented in their workplace in order
to minimize the risk of transmission of COVID-19. As part of the hazard
assessment, employers must inspect the entire workplace to find
existing and potential risks of employee exposure to COVID-19. The
hazard assessment must include an evaluation of employees' potential
workplace exposure to all people present at the workplace, including
coworkers, employees of other entities, members of the public,
customers or clients, independent contractors, visitors, and other non-
employees. Places and times where people may congregate or come in
contact with one another must be identified and addressed, regardless
of whether employees are performing an assigned work task or not. For
instance, people may congregate during meetings or training sessions,
as well as in and around entrances, bathrooms, hallways, aisles,
walkways, elevators, breakrooms or eating areas, and waiting areas. All
of these areas must be identified and addressed as part of the hazard
assessment. Employers must consider how employees and other persons
enter, leave, and travel through the workplace, in addition to
addressing potential COVID-19 hazards employees are exposed to at fixed
work locations.
Employers have flexibility to determine the best approach to
accomplish the overall hazard assessment. For example, the hazard
assessment could be adapted and tailored to specialized clinical
services, the physical characteristics of the workplace, the number of
people in the workplace, or the prevalence of COVID-19 in the
surrounding community. Employers may also want to consult state or
local public health laws, standards, and guidelines in determining how
best to conduct their hazard assessments. While conducting the hazard
assessment, employers must assess each employee's potential COVID-19
exposure but can do so generally. An employer could make a reasonable
assessment based on commonalities of tasks, environmental factors, and
work practices for one shift and prescribe the same protective
controls and work practices to other shifts or exposure groups of
employees with similar hazards and risk. For example, a hospital
employer may not need to conduct an individual hazard assessment for
each receptionist in an emergency room entrance area because the COVID-
19 hazards to which the receptionists are exposed would be the same.
However, if a particular receptionist has additional responsibilities
(e.g., greeting patients, intake for all COVID-19 patients, cleaning of
barriers), those tasks must be taken into consideration as part of the
overall hazard assessment.
When conducting hazard assessments, employers should document the
following information to assist them in developing and implementing
their COVID-19 plans:
Specific hazards or risk factors identified
A plan to abate the identified hazards or risk factors in a
timely manner
Date(s) the assessment was performed
The names and titles of the individuals who participated in
the evaluation and contributed to the written plan
A description of the actions to be taken
Actions planned to address and prioritize mitigation of
identified hazards or risk factors
Identification of high-risk area(s), tasks, and occupations
Communication of the status of planned or completed actions to
employees who may be affected by the identified hazards or risk factors
The dates by which planned actions are to be completed
Written documentation of completed actions including:
[cir] What method(s) of control was/were decided upon
[cir] Area(s) where control(s) was/were implemented
[cir] Specific date(s) of completion
[cir] The names and titles of the individuals who authorized and
managed implementation of control
When an employer identifies a COVID-19-related exposure hazard
during the hazard assessment, the employer must implement controls to
eliminate or mitigate the hazard, such as physical distancing, physical
barriers where appropriate and when distancing is infeasible, PPE, and
cleaning and disinfection protocols. These hazard controls must be
consistent with the relevant requirements in other paragraphs of this
ETS. The employer must develop a reasonable plan to abate identified
COVID-19 hazards.
OSHA acknowledges that some of the controls required under other
paragraphs of this ETS may be potentially infeasible in some
situations. However, even in cases where an employer can demonstrate
that a particular control is appropriate but is not feasible, the
employer should still identify and implement alternative measures to
protect employees from COVID-19 exposure(s) to the extent feasible.
This ETS relies on a multi-layered strategy to minimize employee
exposure to COVID-19, and each of the controls provides a layer of
protection for employees. Therefore, when an employer is not
implementing a control that is appropriate but is not feasible, the
employer should take alternative abatement measures to account for the
loss of that protective layer.
A finding of infeasibility is made on a case-by-case basis and is
highly dependent on the specific circumstances and facts in each
workplace. The concept of an infeasibility defense for non-compliance
with an OSHA standard is well-established under OSHA case law and is
always potentially available to employers. In general, compliance with
an OSHA standard is feasible when it is capable of being done.
Situations where some of the controls required under this ETS may be
infeasible might include where employees cannot maintain 6 feet of
distance from all other people in the workplace and also cannot remain
behind physical barriers while providing services (see the Summary and
Explanation for Physical Distancing for additional discussion about
distancing requirements). In these situations, employers should
consider implementing additional measures to protect their employees.
An employer might identify other hazards during its hazard
assessment that warrant providing additional PPE to its employees,
beyond what is required by other paragraphs of this ETS. For example,
there may be employees whom the employer would not be required to
provide respirators pursuant to paragraph (f)(2) because the employees
are not exposed to a person with suspected or confirmed COVID-19.
However, those employees may face increased likelihood of COVID-19
exposure because they work in an environment where people with COVID-19
may be present. An employer may also have an employee who has an
underlying medical condition or other risk factors (e.g., chronic
obstructive pulmonary disease, heart condition, pregnancy) that would
place that employee at greater risk for severe illness if they get
COVID-19 (CDC, May 13, 2021). In these situations, employers could
consider upgrading the PPE provided to employees if their health
condition does not prevent it. As explained in paragraph (f)(4)(i), if
an employer provides a respirator in lieu of the required facemask,
then the employer must comply with the requirements under the COVID-19
Emergency Temporary Standard -- Mini Respiratory Protection Program (29
CFR 1910.504, herein referred to as the mini respiratory protection
program section). This ETS reduces the burden on employers and
employees who choose to upgrade to a respirator by allowing them to use
respirators pursuant to the mini respiratory protection program
section. Additional information about the mini respiratory protection
program section can be found in the summary and explanation for that
section.
Paragraph (c)(4)(ii) requires employers seeking to be exempt from
providing controls under paragraph (a)(4) to include policies and
procedures in their COVID-19 plans to determine employees' vaccination
status. Although this requirement only applies to employers seeking the
exemption under paragraph (a)(4), the following discussion is also
relevant to employers seeking the exemption from the scope of the ETS
under paragraphs (a)(2)(iv) and (a)(2)(v). Employers seeking these
exemptions must determine employees' vaccination status in order to
determine whether the exemption from the ETS applies. In order to make
the determination of which workers are fully vaccinated, employers
could, for example, vaccinate their workforce themselves; review CDC
vaccination cards or similar verification issued by a pharmacy,
healthcare provider, or other vaccinator; if available, review state-
issued passes; or simply ask workers to attest whether they have been
fully vaccinated. If the employer is not able to determine that an
employee is fully vaccinated, the employer must treat that employee as
not fully vaccinated. Additional information about the exemptions in
paragraph (a)(4) can be found in the Summary and Explanation for
paragraph (a) (Scope and application).
Under paragraph (c)(5), the employer must seek the input and
involvement of non-managerial employees and their representatives, if
any, in the hazard assessment and the development and implementation of
the COVID-19 plan. An employer can seek feedback from employees through
a variety of means, including safety meetings, a safety committee,
conversations between a supervisor and non-managerial employees, a
process negotiated with the exclusive bargaining agent (if any), or any
other similarly interactive
process. Other tools that may be helpful for employers in soliciting
feedback from employees may include employee surveys or a suggestion
box. The method of soliciting employee input is flexible and may vary
based on the employer and the workplace. For example, a large employer
with many employees may find a safety committee with representatives
from various job categories combined with anonymous suggestion boxes to
be more effective than individual conversations between supervisors and
non-managerial employees. In the case of a unionized workplace, a
safety committee established through a collective bargaining agreement
may be the appropriate source for this input based on the definition
and scope of the committee's work. In contrast, a small employer might
determine that an ongoing interactive process between the employer and
employees (e.g., regular safety meetings) is a more effective means of
soliciting employee feedback.
The employer must monitor each workplace to ensure the ongoing
effectiveness of the COVID-19 plan and update it as needed, as required
in paragraph (c)(6). For example, COVID-19 plans may need to be updated
as more information about COVID-19 becomes available from the CDC, or
state and local agencies. Additionally, the safety coordinator might
learn of a deficiency during an inspection or from another employee.
Any deficiencies identified must be immediately addressed, and re-
training of all affected employees must occur.
Paragraph (c)(7) requires an employer's COVID-19 plan to address
the hazards identified during the hazard assessment required by
paragraph (c)(4), and to include policies and procedures in accordance
with paragraphs (c)(7)(i) through (c)(7)(iii). Paragraph
(c)(7)(i)requires employers to develop policies and procedures to
minimize the risk of transmission of COVID-19 for each employee, as
required by paragraphs (d) through (n). Information about the
requirements of those paragraphs can be found in the corresponding
sections of the Summary and Explanation. Each of these elements, when
implemented together, provide multiple layers of protection for
employees. As explained in the note to paragraph (c)(7)(i), although
the employer's COVID-19 plan must account for the potential COVID-19
exposures to each employee, the plan can do so generally and need not
address each employee individually. For example, employers could
address unvaccinated employees collectively when pointing to hazards
from exposure to other unvaccinated employees, patients, or visitors
and instructing them what protective actions those employees are
expected to follow for specific situations such as when a visitor
enters without the source control of a face covering.
The provisions in paragraph (c)(7)(ii) address effective
communication and coordination among employers. Specifically, these
provisions prescribe the information-sharing responsibilities of
employers who share the same physical location. OSHA intends this
requirement to help prevent employees of one employer from creating
hazards for employees of a different employer, and to facilitate
information-sharing between employers when one employer has the
authority to address ventilation, barrier installation, or cleaning in
an area occupied by employees of a different employer. As explained
above, physical location means a site, or an area within a site, where
work or any work-related activity occurs. The full definition for
physical location can be found in paragraph (b). The provisions in
(c)(7)(ii) are necessary to ensure that critical information-sharing
and coordination take place at all workplaces covered by the ETS.
When employees of different employers share the same physical
location, paragraph (c)(7)(ii)(A) requires that each employer
communicate its COVID-19 plan to all other employers present and
coordinate to ensure that each of its employees is protected.
Additionally, employers must adjust their COVID-19 plans to address any
particular COVID-19 hazards presented by the other employer's employees
who share the physical location.
Paragraph (c)(7)(ii)(A) does not apply to delivery people,
messengers, and other employees who only enter a workplace briefly to
drop off or pick up items. For example, if an employee of a delivery
company enters a workplace to deliver a package and then immediately
leaves the workplace, the employers regularly present at the physical
location (e.g., the employer receiving the package) and the delivery
company do not need to communicate their COVID-19 plans in accordance
with this paragraph.
Multiple employers working in the same physical location occurs
regularly. For example, in a hospital setting, an employer might
subcontract nursing or housekeeping tasks to other employers. When this
happens, each employer performing work at the site must communicate
their COVID-19 plans to the other employers and coordinate with them to
ensure all employees are adequately protected from COVID-19 exposure.
If the subcontracted employee is not properly protected and becomes
infected, that employee could pose a transmission risk to other
healthcare staff. In some cases, multiple employers may need to work
collaboratively for either or both employers to become eligible for
exceptions involving vaccinated employees. Paragraph (c)(7)(ii)(B)
contains a notification requirement for employers with one or more
employees working in a physical location controlled by another
employer. Specifically, those employers must notify the controlling
employer when their employees are exposed to conditions at the location
that do not meet the requirements of this section. Examples of
conditions that might not meet the requirements of this section that
would need to be reported could include communal high-touch surfaces
(e.g., elevator buttons or bathroom facilities) that are not being
adequately cleaned, or a physical barrier that has fallen down.
The communication and coordination provisions in paragraph
(c)(7)(ii) are in addition to, and do not modify, OSHA's existing
multiemployer citation policy, including a controlling employer's
obligation to exercise reasonable care to detect and prevent violations
on the worksite.
Lastly, paragraph (c)(7)(iii) includes requirements for employers
whose employees enter private residences or other physical locations
controlled by people not covered by the OSH Act (e.g., homeowners, sole
proprietors). These employers must include policies and procedures in
their COVID-19 plans to protect their employees entering those
locations, including procedures for leaving the worksite if protections
prove inadequate. Several methods of protecting employees are discussed
in the technological feasibility section of this document.
References
Centers for Disease Control and Prevention (CDC). (2021, March 8).
Guidance for Businesses and Employers Responding to Coronavirus
Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html. (CDC, March 8, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 17).
Healthcare Facilities: Managing Operations During the COVID-19
Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-hcf.html. (CDC, March 17, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
People with Certain Medical Conditions. https://www.cdc.gov/
coronavirus/2019-ncov/need-extra-precautions/people-with-
medical-conditions.html. (CDC, May 13, 2021).
Equal Employment Opportunity Commission (EEOC). (2021, May 28). What
You Should Know About COVID-19 and the ADA, the Rehabilitation Act,
and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. (EEOC,
May 28, 2021).
Occupational Safety and Health Administration (OSHA). (2020, March
9). Guidance on Preparing Workplaces for COVID-19. https://www.osha.gov/Publications/OSHA3990.pdf. (OSHA, March 9, 2020).
Occupational Safety and Health Administration (OSHA). (2020, June
18). Guidance on Returning to Work. https://www.osha.gov/Publications/OSHA4045.pdf. (OSHA, June 18, 2020).
Occupational Safety and Health Administration (OSHA). (2021, January
29). Protecting Workers: Guidance on Mitigating and Preventing the
Spread of COVID-19 in the Workplace. https://www.osha.gov/coronavirus/safework. (OSHA, January 29, 2021).
United States Department of Labor (DOL). (2020). Summary of the
Major Laws of the Department of Labor. https://www.dol.gov/general/aboutdol/majorlaws. (DOL, 2020).
C. Patient Screening/Management
Patient screening and management strategies aim to identify and
manage those individuals who may have COVID-19 before entering a
facility so that appropriate precautions can be implemented to prevent
transmission to others within the workplace. Therefore, paragraph (d)
includes provisions for screening and management of persons, including
patients, entering settings where direct patient care is provided. The
patient screening and management required under paragraph (d) is in
addition to health screening for employees that is required under
paragraph (l)(1). The additional screening required under paragraph (d)
does not extend to employers covered by the ETS that do not provide
direct patient care.
Paragraph (d)(1) requires employers in settings where direct
patient care is provided to limit the number of entrances to the
facility, as well as provide a monitoring system for each point of
entry to ensure that persons do not enter the facility without going
through screening. Paragraph (d)(1) does not apply to emergency
responders or other licensed healthcare providers entering a non-
healthcare setting or private residence to provide healthcare services.
For example, this provision would not apply to a paramedic providing
care to a person in their private residence.
Under paragraph (d)(2), employers must screen all individuals who
enter the facility (e.g., clients, patients, residents, delivery people
and other visitors, and other non-employees). As defined in paragraph
(b), screen means asking questions to determine whether a person is
COVID-19 positive or has symptoms of COVID-19. Although it is not a
perfect tool, screening is an important aspect of a multi-layered
approach to minimizing workplace exposures to COVID-19. Employers must
include their screening and management procedures in their COVID-19
plans, which must be written if the workplace setting has more than 10
employees (see paragraphs (c)(7)(i), (c)(2)). As noted following
paragraph (d), the use of telehealth services, when appropriate and
available, is encouraged. For example, employers may use phone or video
platforms to conduct screening on a patient, client, resident, or other
visitor prior to their arrival at the facility/workplace. Employers
could also schedule patients for telehealth visits, where medically
appropriate. Using telehealth in these ways helps to reduce the number
of individuals entering a facility/workplace as well as reduce employee
exposure, while not compromising the health of the patient.
OSHA notes that it views asking questions about COVID-19 symptoms
and illness as the minimum requirement for screening. Employers may
choose to employ other methods in addition to the required questions,
such as temperature checks, in the conduct of screening. Screening may
also include confirming that individuals are abiding by the employer's
policies and procedures for wearing face coverings in the facility, in
accordance with paragraph (d)(3), as well as assessing individuals'
recent exposures to COVID-19.
Under this same provision (paragraph (d)(2)), employers are also
required to establish policies to triage any individual who may be
experiencing COVID-19 symptoms or illness. The screening and triage
process is a tool to identify patients who require specific patient
management practices under paragraph (d)(3) in order to protect both
employees and other patients or visitors. In some cases, visitors who
present with COVID-19 symptoms or illness may be restricted from
entering and referred to a physician or different facility for proper
evaluation. Other triage policies could include: Rescheduling of
surgery, physician visit, or home health visit; referral for treatment
and isolation of the patient to a separate area; or if at a home visit,
leaving the residence and rescheduling the visit. When an in-person
visit is unavoidable, each employer must develop policies and
procedures, including those required by the remaining provisions of the
ETS, to triage those patients who are identified through screening as
having COVID-19 symptoms or illness and ensure employee protection from
COVID-19 transmission. Those patients should either be isolated in a
separate area (e.g., examination room) with the door closed or asked to
wait in their vehicle to be called in for their appointment. The CDC
offers additional guidance on triaging patients (CDC, February 25,
2021).
Paragraph (d)(3) requires employers to implement other applicable
patient management strategies. OSHA notes that in this context, patient
management strategies must address the management of individuals other
than patients who enter the facility for patient-related reasons, such
as family members or others who accompany patients to ambulatory care
appointments or visit hospitalized patients or nursing home residents.
The applicable patient management strategies the employer must
implement under paragraph (d)(3) must be in accordance with the ``CDC's
COVID-19 Infection Prevention and Control Recommendations'', which is
incorporated by reference as specified in 29 CFR 1910.509 (CDC,
February 23, 2021). For example, that document provides for patients
and visitors to wear well-fitting source control (cloth masks,
facemasks, or respirators) and for appropriate patient placement to
help reduce the risk of COVID-19 transmission. OSHA expects employers
to comply with these and other patient management strategies in the
``CDC's COVID-19 Infection Prevention and Control Recommendations,'' to
the extent they are applicable.
As another example of a patient management strategy, patients who
have been admitted may need to be screened daily for new fever onset or
other suspected COVID-19 symptoms, as they may require additional
medical treatment, or may need placement on appropriate Transmission-
Based Precautions (see next section). If the admitted patient develops
a high fever and persistent cough, which may indicate a possible COVID-
19 infection, that patient may need to be isolated in a private room
and placed under Droplet Precautions or Airborne Precautions.
Transmission-Based Precautions are further described in the Summary and
Explanation of Standard and Transmission-Based Precautions.
Other patient management strategies include posting visual alerts
(e.g., signs,
posters) at the entrance and in other strategic places (e.g., waiting
areas, elevators) relevant to patient management practices that provide
instructions in appropriate languages and education levels about
wearing face coverings, maintaining physical distancing, and performing
timely hand hygiene and proper respiratory etiquette. It may also be
necessary to provide face coverings for patients and visitors, as well
as supplies for hand and respiratory hygiene, including hand sanitizer
(with at least 60% alcohol), tissues, and no-touch waste receptacles at
entrances, in waiting areas, and at patient check-ins.
References
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim Infection Prevention and Control Recommendations for
Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
25). Standard Operating Procedure (SOP) for Triage of Suspected
COVID-19 Patients in non-U.S. Healthcare Settings: Early
Identification and Prevention of Transmission during Triage. https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-us-settings/sop-triage-prevent-transmission.html. (CDC, February 25, 2021).
D. Standard and Transmission-Based Precautions
Standard and Transmission-Based Precautions are the cornerstone for
all infection prevention activities to prevent the transmission of
communicable diseases to employees, patients, and other non-employees
in healthcare settings. Under paragraph (e), employers are required to
develop and implement policies and procedures that adhere to Standard
and Transmission-Based Precautions in accordance with ``CDC's
Guidelines for Isolation Precautions'' (incorporated by reference,
Sec. 1910.509) to reduce the transmission of COVID-19. The Standard
and Transmission-Based Precautions required by the ETS only extend to
exposure to SARS-CoV-2 and COVID-19 protection. The agency does not
intend the ETS to apply to other workplace hazards. The ``CDC's
Guidelines for Isolation Precautions'' (Siegel et al., 2007) is an
authoritative standard for infection prevention and control.
Standard Precautions must be implemented regardless of the presence
of a suspected or confirmed infectious agent, such as COVID-19. The use
of Standard Precautions thus relies on the assumption that every
patient, all potentially-contaminated materials, and all human remains
in healthcare settings are potentially infected or colonized with an
infectious agent. Standard Precautions are similar to, but more
extensive than, ``universal precautions,'' which are required by OSHA's
Bloodborne Pathogens standard (the BBP standard, 29 CFR 1910.1030), to
prevent contact with blood or other potentially infectious materials
(as that term is defined in the BBP standard). Standard Precautions
were developed to integrate principles of universal precautions into
broader principles pertaining to routes of exposure other than the
bloodborne route, such as via the contact, droplet, or airborne routes.
For example, although the BBP standard might not apply, Standard
Precautions would be utilized when employees are exposed to urine,
feces, nasal secretions, sputum, vomit, and other body fluids, and also
when employees are exposed to mucous membranes and non-intact skin
(Siegel et al., 2007). Standard Precautions assume that when there is
exposure to these materials, the materials potentially contain
infectious agents that could be transmitted via the contact, droplet,
or airborne routes.
The infection prevention and control methods used under Standard
Precautions will likely be similar to, but more extensive than, what
employers should already be implementing to protect employees against
exposures under the BBP standard. Standard Precautions not only include
the infection control methods specified as universal precautions (e.g.,
hand hygiene, the use of certain types of PPE based on anticipated
exposure, safe injection practices, and safe management of contaminated
equipment and other items in the patient environment), but also
include, for example, respiratory and cough etiquette (Siegel et al.,
2007).
Transmission-Based Precautions are infection control practices that
are used in tandem with Standard Precautions but are based on the way
an infectious agent(s) may be transmitted. Transmission-Based
Precautions are the second tier of basic infection control and are to
be used in addition to Standard Precautions for patients who may be
infected or colonized with certain infectious agents, such as COVID-19,
for which additional precautions are needed to prevent infection
transmission. Unlike Standard Precautions, Transmission-Based
Precautions are only implemented if the presence of an infectious
agent, such as COVID-19, is suspected or confirmed.
There are three categories of Transmission-Based Precautions:
Contact Precautions, Droplet Precautions, and Airborne Precautions
(Siegel et al., 2007).\132\ For diseases that have multiple routes of
transmission, more than one category of Transmission-Based Precautions
must be used. Whether one category or multiple categories of
Transmission-Based Precautions are used, they are always used in
addition to Standard Precautions. As described in Grave Danger (Section
IV.A. of this preamble), COVID-19 is capable of contact, droplet, and
airborne transmission in healthcare settings. As such, employers must
follow the appropriate precautions specified for these transmission
pathways, as applicable to their workplaces.
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\132\ Contact Precautions are designed to prevent transmission
of infectious agents spread by direct or indirect physical contact
with an infected or contaminated individual, item, or surface.
Droplet Precautions are designed to prevent transmission of
infectious agents spread by direct respiratory or mucous membrane
contact with infectious droplets. Airborne Precautions are designed
to prevent transmission of infectious agents that remain infectious
over long distances and time when suspended in the air. (Siegel et
al., 2007).
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An extensive review of current policies and procedures will help
employers ensure that paragraph (e) is met; when necessary, employers
must develop and implement any missing policies and procedures to
adhere to Standard and Transmission-Based Precautions. Additional
details on Standard and Transmission-Based Precautions are also
available in Need for Specific Provisions (Section V of this preamble).
OSHA notes that the CDC has issued general and COVID-19-specific
recommendations that can inform employers developing and implementing
both Standard and Transmission-Based Precautions in accordance with
``CDC's Guidelines for Isolation Precautions'' (Siegel et al., 2007).
In developing policies and procedures in accordance with paragraph (e),
employers can look to a variety of sources, including Interim Infection
Prevention and Control Recommendations for Healthcare Personnel During
the Coronavirus Disease 2019 (COVID-19) Pandemic (CDC, February 23,
2021); Discontinuation of Transmission-Based Precautions and
Disposition of Patients with COVID-19 in Healthcare Settings (Interim
Guidance) (CDC, February 16, 2021); and Collection and Submission of
Postmortem Specimens from Deceased Persons with Confirmed or Suspected
COVID-19: Postmortem Guidance (CDC, December 2, 2020). As discussed in
Technological Feasibility (Section VI.A. of this preamble), many
employers subject to the ETS have already implemented these guidelines
in their workplaces, and the control practices contained in these
guidelines are technologically feasible.
References
Centers for Disease Control and Prevention (CDC). (2020, December
2). Collection and Submission of Postmortem Specimens from Deceased
Persons with Confirmed or Suspected COVID-19: Postmortem Guidance.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-postmortem-specimens.html. (CDC, December 2, 2020).
Centers for Disease Control and Prevention (CDC). (2021, February
16). Discontinuation of Transmission-Based Precautions and
Disposition of Patients with COVID-19 in Healthcare Settings
(Interim Guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html. (CDC, February 16, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim Infection Prevention and Control Recommendations for
Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Siegel, J.D., Rhinehart, E., Jackson, M., Chiarello, L., and the
Healthcare Infection Control Practices Advisory Committee. (2007).
2007 Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings. Centers for Disease
Control and Prevention. https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html. (Siegel et al., 2007).
E. Personal Protective Equipment (PPE)
I. Facemasks
Paragraph (f) contains requirements for personal protective
equipment (PPE). The PPE requirements in paragraph (f) apply to
employees in covered workplaces, with the exception of fully-vaccinated
employees in well-defined areas where there is no reasonable
expectation that any person with suspected or confirmed COVID-19 will
be present (see paragraph (a)(4) and the Summary and Explanation for
paragraph (a)). First, paragraph (f)(1) addresses the use of facemasks.
Facemasks are required by the ETS because they offer both source
control (i.e., reducing the spread of large respiratory droplets to
others by covering an infected person's mouth and nose) and protection
for the wearer. As defined in paragraph (b), facemasks are surgical,
medical procedure, dental, or isolation masks that are FDA-cleared,
authorized by an FDA EUA, or offered or distributed as described in an
FDA enforcement policy. A detailed discussion on the use of facemasks
is in Need for Specific Provisions (Section V of the preamble).
Paragraph (f)(1)(i) imposes the requirement that employers must
provide, and ensure that employees wear, a facemask that meets the
definition in paragraph (b) of this section. Facemasks provide
protection against exposure to splashes, sprays, and spatter of body
fluids from patients and others. Many employees in healthcare are
exposed to, and therefore need protection from, this hazard. This
requirement is based on CDC recommendations (CDC, February 23, 2021),
and OSHA has previously established that facemasks are essential PPE
for employees in healthcare, under both the general PPE standard (29
CFR 1910.132) and the Bloodborne Pathogens standard (29 CFR 1910.1030).
Paragraph (f)(1)(ii) requires that employers ensure a facemask is
worn over the nose and mouth when an employee is indoors and when
occupying a vehicle with other people for work purposes. To be worn
properly, facemasks need to completely cover the wearer's mouth and
nose, and fit snugly against the sides of the face without gaps.
Employers must train employees on when and how to properly wear a
facemask in accordance with paragraph (n). Additionally, to ensure
facemasks are worn properly, an employer might appoint a manager or
senior employee to check that each employee is properly wearing a
facemask at the start of and throughout each shift. To serve as
additional reminders for employees, employers may want to display
signs/posters throughout the facility about proper facemask usage.
Paragraph (f)(1)(ii) further requires employers to provide a
sufficient number of facemasks to each employee as needed to comply
with paragraph (f) and to ensure that each employee changes facemasks
at least one per day, whenever they are soiled or damaged, and more
frequently as necessary (e.g., patient care reasons). Facemasks can
become soiled or dirty by splashes, sprays, or spatters, from contact
with a contaminated surface, or by touching/adjusting it with
contaminated hands. Because facemasks can become soiled after each use
with bacteria and viruses, including the virus that causes COVID-19, it
is important they are replaced as specified in this paragraph,
including when they are soiled or damaged. Thus, employers are required
to provide a sufficient number of facemasks to each employee to ensure
compliance with these provisions. Employers might consider providing
supplemental face shields (further described below) to wear over
facemasks, which would reduce the frequency with which they become
soiled and the rate at which employees would have to change them during
the day.
Paragraph (f)(1)(iii) contains exceptions to the facemask
requirements imposed in paragraph (f)(1)(ii) of this section. First, as
described in paragraph (f)(1)(iii)(A), when an employee is alone in a
room, they are not required to wear a facemask. However, if the
employee exits the room or another individual enters the room,
facemasks are required.
Under another exception, paragraph (f)(1)(iii)(B), employees are
not required to wear facemasks while eating or drinking at the
workplace, as long as each employee is at least 6 feet apart or
separated by physical barriers from all other people. Employers may
accomplish this by staggering break times, allowing use of non-
traditional break areas (e.g., conference rooms), or letting employees
eat or drink outside where there may be more space, to ensure each
employee is at least 6 feet apart while eating or drinking. Additional
information on physical distancing and physical barriers is discussed
further in the Summary and Explanation for paragraphs (h) and (i),
respectively.
The next exception, under paragraph (f)(1)(iii)(C), provides that
facemasks are not required for employees when they are wearing
respiratory protection in accordance with 29 CFR 1910.134 or paragraph
(f) of this section. Employees required to use respiratory protection
in accordance with 29 CFR 1910.134 for certain workplace hazards
unrelated to the COVID-19 pandemic are exempt from the facemask
requirements outlined in paragraph (f)(1) while they are wearing the
respirators. Respirators provide some source control but also more
critical protection to the wearer. Similarly, while employees are
wearing respirators in connection with the COVID-19 hazard, as required
in paragraphs (f)(2)-(f)(3) and (f)(5), they are exempt from the
facemask requirement. Finally, employees using respirators in
compliance with the mini respiratory protection program section of this
standard for voluntary respirator use are also exempt from the facemask
requirement in paragraph (f)(1) while wearing a respirator. This is
discussed in further detail in paragraph (f)(4) on
employee use of respirators when they are not required.
Paragraph (f)(1)(iii)(D) contains another exception for facemask
use when it is important to see a person's mouth (e.g., communicating
with an individual who is deaf or hard of hearing) and the conditions
do not permit a facemask that is constructed of clear plastic (or
includes a clear plastic window). In such situations, the employer must
ensure that each employee wears an alternative to protect the employee,
such as a face shield, if the conditions permit it.
Similarly, paragraph (f)(1)(iii)(E) contains an exception for
employees who cannot wear facemasks due to a medical necessity, medical
condition, or disability as defined in the Americans with Disabilities
Act (42 U.S.C. 12101 et seq.), or due to a religious belief. Exceptions
must be provided for a narrow subset of persons with a disability who
cannot wear a facemask or cannot safely wear a facemask, because of the
disability, as defined in the Americans with Disabilities Act (42
U.S.C. 12101 et seq.), including a person who cannot independently
remove the facemask. The remaining portion of the subset who cannot
wear a facemask may be exempted on a case-by-case basis as required by
the Americans with Disabilities Act and other applicable laws. In all
such situations, the employer must ensure that each employee wears a
face shield for the protection of the employee, if their condition or
disability permits it. Accommodations may also need to be made for
religious beliefs consistent with Title VII of the Civil Rights Act.
Under the final exception, contained in paragraph (f)(1)(iii)(F), a
facemask is not required for an employee if the employer can
demonstrate that the use of a facemask presents a hazard to the
employee of serious injury or death (e.g., arc flash, heat stress,
interfering with safe operation of equipment). This exception ensures
employees remain protected from other potential or known workplace
hazards that could lead to injury. In such situations, the employer
must ensure that each employee wears an alternative to protect the
employee, such as a face shield, if the conditions permit it. OSHA
notes that specialized facemasks, or other specialized equipment that
does not meet the definition of a facemask in paragraph (b), may be
available to protect against the relevant hazard and also allow
effective protection against COVID-19. Any employee not wearing a
facemask under this exception must remain at least 6 feet away from all
other people unless the employer can demonstrate it is not feasible.
Finally, under this exception, the employee must resume wearing a
facemask when not engaged in the activity where the facemask presents a
hazard.
A note to paragraph (f)(1)(iii)(F) states that, with respect to
paragraphs (f)(1)(iii)(D)-(F), the employer may determine that the use
of a face shield without a facemask, in certain settings, is not
appropriate due to other infection control concerns. These infection
control concerns, along with the rationale for this note, are discussed
in detail in Need for Specific Provisions (Section V of the preamble).
II. Face Shields
Paragraph (f)(1)(iv) outlines requirements for face shields. As
defined in paragraph (b), face shields are devices, typically made of
clear plastic, that (i) are certified to ANSI/ISEA Z87.1, which is
incorporated by reference in 29 CFR 1910.509; or (ii) cover the
wearer's eyes, nose, and mouth to protect from splashes, sprays, and
spatter of body fluids, wrap around the sides of the wearer's face
(i.e., temple-to-temple), and extend below the wearer's chin. These
specifications are critical design parameters for face shields to
effectively contain respiratory droplets and prevent droplet
transmission.
Paragraph (f)(1)(iv) first states that when a face shield is
required to comply with paragraph (f), or is otherwise required by the
employer, the employer must ensure that the face shields are cleaned at
least daily and are not damaged. Like facemasks, face shields can
become soiled or dirty by splashes, sprays, or spatters, from contact
with a contaminated surface, or by touching or adjusting the face
shield with contaminated hands. Each time they are worn, face shields
can become contaminated with bacteria and viruses, including the virus
that causes COVID-19, which poses a risk of transmission to employees
upon contact. Additionally, damaged face shields may not fit properly
and thus not meet the required specifications, thereby reducing their
effectiveness. Thus, employers must ensure that face shields are
regularly cleaned and are not used if damaged.
When an employee provides their own face shield, paragraph
(f)(1)(iv) specifies that such face shield must meet the definition in
paragraph (b) and the employer is not required to reimburse the
employee for that face shield. In order to encourage the voluntary use
of face shields, OSHA is not imposing a separate duty on employers to
inspect or clean employee-provided face shields. Because OSHA
anticipates that employees choosing to voluntarily bring in their own
face shields for extra protection will also wear their face shields
outside of work, employees are expected to continue to care for them
and provide proper cleaning as necessary. The general availability of
cleaning supplies in the workplace, particularly if employer-provided
face shields were also available, would be sufficient to allow workers
to clean their own personal face shields as appropriate. More
significantly, while employer-provided face shields must be thoroughly
cleaned and disinfected because they might be shared between employees,
this particular reason for cleaning would not apply to personal face
shields, which would not be shared. Inspection is not required for
employee-provided face shields because the most likely damage to a face
shield (e.g., failure of the head harness or strap, or cracks in the
face shield) would render the face shield unusable or be blatantly
obvious and employees could revert to an employer-provided face shield,
if required.
III. Respirators and Other PPE
Paragraphs (f)(2) through (f)(5) contain requirements addressing
the provision and use of respirators and other PPE. Information on why
OSHA is requiring the provision and use of respirators is discussed in
greater detail in Need for Specific Provisions (Section V of this
preamble).
As defined in paragraph (b), a respirator is a type of PPE that is
certified by NIOSH under 42 CFR part 84 or is authorized under an EUA
by the FDA. These specifications are intended to ensure some consistent
level of testing, approval, and protection and to prevent the use of
counterfeit respirators that will not offer adequate protection, which
is important because respirators are intended to protect the wearer
when directly exposed to hazards. Respirators protect against airborne
hazards by removing specific air contaminants from the ambient
(surrounding) air or by supplying breathable air from a safe source.
Common types of respirators include filtering facepiece respirators
(FFRs), elastomeric respirators, and powered air-purifying respirators
(PAPRs). Face coverings, facemasks, and face shields are not
respirators.
Paragraph (b) also contains definitions for the types of
respirators referred to in the definition of respirator. A filtering
facepiece respirator (FFR) is a negative-pressure particulate
respirator with a non-replaceable filter as an integral part of the
facepiece or with the entire facepiece composed of the non-
replaceable filtering medium. N95 FFRs are the most common type of FFR
and are the type of respirator most often used to control exposures to
infections transmitted via the airborne route. When properly worn, N95
FFRs filter at least 95% of airborne particles (CDC, January 11, 2021).
An elastomeric respirator, also defined in paragraph (b), is a tight-
fitting respirator with a facepiece that is made of synthetic or rubber
material that permits it to be disinfected, cleaned, and reused
according to the manufacturer's instructions. Elastomeric respirators
are equipped with replaceable cartridges, canisters, or filters.
Lastly, a powered air-purifying respirator (PAPR) is an air-purifying
respirator that uses a blower to force the ambient air through air-
purifying elements to the inlet covering. In general, an employer may
provide and ensure the use of any of these respirator types to comply
with the requirements in paragraphs (f)(2) through (f)(5).
Paragraph (f)(2) addresses the provision and use of respirators and
other PPE for exposure to a person with suspected or confirmed COVID-
19. A detailed discussion of OSHA's rationale for requiring employers
to provide and ensure the use of respirators and other PPE for exposure
to a person with suspected or confirmed COVID-19 is in the Need for
Specific Provisions (Section V of the preamble).
Paragraph (f)(2) requires two types of PPE whenever employees have
``exposure'' to a person with suspected or confirmed COVID-19. In this
context, exposure refers to close proximity, which includes being
within 6 feet or in the same room. As part of their COVID-19 hazard
assessments, employers must assess their facilities and practices and
identify areas where employees are reasonably anticipated to be exposed
to a person with suspected or confirmed COVID-19. This understanding of
exposure is consistent with the process employers are expected to
follow under OSHA's Bloodborne Pathogens standard, 29 CFR 1910.1030.
Employers should always anticipate that personnel involved in
direct patient care will have exposure whenever they are treating
patients who are suspected or confirmed to have COVID-19. For example,
when the patient or client is suspected or confirmed to have COVID-19,
exposure should be anticipated in the following types of situations:
Medical examinations, regardless of where they are
conducted;
Medical assistant performing a nasal swab on a patient at
a COVID-19 testing location;
Home healthcare aide bathing a patient in the patient's
home;
A dental hygienist setting plates in a patient's mouth for
x-rays of a patient in a dental office.
In other cases, whether an employer should reasonably anticipate
exposure to persons with suspected or confirmed COVID-19 depends on the
employee's location and job duties. Thus, for example, employers should
anticipate that an employee conducting screening and triage of patients
in an emergency room would have exposure to persons with suspected or
confirmed COVID-19, as their job involves determining whether patients
have symptoms that are consistent with a COVID-19 diagnosis. Likewise,
a security guard stationed at the entrance of an emergency room or
COVID-19 testing location should anticipate some exposure to visitors
with COVID-19. On the other hand, exposure would not normally be
anticipated for a security guard stationed at an employee-only entrance
where the employees are regularly screened for COVID-19 symptoms. A few
other examples of employees whose anticipation of exposure would vary
by job task or locations include the following:
Housekeeping or other healthcare support personnel whose
duties involve entry into a room (or enclosed space, such as a
partitioned patient area in an emergency room) of a suspected or
confirmed COVID-19 patient to exchange laundry, clean, or remove trash.
A maintenance person who enters the room of a patient with
suspected or confirmed COVID-19 or changes a light in a hallway while
such patients are nearby.
A nutritionist entering the room of a resident with
suspected or confirmed COVID-19 in a nursing home to discuss dietary
requirements.
As part of the COVID-19 plan development, employers must take steps
to minimize avoidable exposure of employees like janitors and
housekeeping personnel to persons with suspected or confirmed COVID-19.
For example, employers can implement administrative controls to
restrict visitors who are suspected to have COVID-19 to specific areas
and away from as many staff as possible. Employers can also designate a
limited group of janitors, food service, or maintenance staff to handle
all entries into rooms of suspected or confirmed COVID-19 patients and
defer maintenance or other services until after the patient has left
the room and there is an opportunity for an air exchange. Employers can
implement policies restricting the movement of patients who are
suspected or confirmed to have COVID-19, keep the doors to their rooms
closed, and locate them in specific areas of the facility where there
is less likelihood of unexpected interaction with staff.
The types of PPE necessary to reduce employee risks from these
exposures are specified in paragraphs (f)(2)(i) and (f)(2)(ii). First,
under paragraph (f)(2)(i), the employer must provide a respirator to
each employee and ensure that it is provided and used in accordance
with OSHA's Respiratory Protection standard (29 CFR 1910.134). Second,
under paragraph (f)(2)(ii), the employer must provide gloves, an
isolation gown or protective clothing, and eye protection to each
employee and ensure that the PPE is used in accordance with OSHA's PPE
standard, 29 CFR part 1910, subpart I. The Respiratory Protection
standard requires, among other things, that the employer develop and
implement a written respiratory protection program with required
worksite-specific procedures and elements for required respirator use.
The program must include several elements, such as procedures for fit
testing and medical evaluations of employees. In any setting covered
under the ETS where employees are exposed to persons with known or
suspected COVID-19, employers are required to provide and ensure the
use of N95 FFRs or higher-level respirators and follow all requirements
under 29 CFR 1910.134.
The COVID-19 pandemic has had an unprecedented impact on the
availability of FFRs, particularly N95 FFRs. While earlier in the
pandemic there were shortages and supply chain disruptions, more
recently the CDC acknowledged that the supply and availability of
NIOSH-approved respirators have increased significantly over the last
several months (CDC, April 9, 2021). Nonetheless, there may be times
when individual employers experience limitations or disruptions to the
supply of FFRs. Thus, a note to paragraph (f)(2) provides that, when
there is a limited supply of FFRs, OSHA will permit employers to follow
the CDC's ``Strategies for Optimizing the Supply of N95 Respirators''
(CDC, April 9, 2021). OSHA will examine whether there is a limited
supply of FFRs on a case-by-case basis, and intends this note to apply
only for the limited time when there is a limited supply of FFRs. For
example, where respirators or associated supplies and services are
readily available, this note will not apply. The note to paragraph
(f)(2) also encourages employers to select elastomeric respirators or
PAPRs instead of FFRs to
prevent shortages and supply chain disruption, where possible. Since
elastomeric respirators and PAPRs are reusable, they offer the
advantage of repeated use by employees, both during and beyond the
pandemic. It should be noted that elastomeric respirators and PAPRs
have specific use limitations and restrictions that need to be
understood when determining whether they are appropriate for specific
applications (CDC, October 13, 2020). Therefore, employers should
evaluate and determine whether elastomeric respirators or PAPRs are
suitable for particular tasks prior to using them as alternatives to
FFRs. For example, an elastomeric respirator with an exhalation valve
should not be used during surgical procedures due to concerns that air
coming out of the valve may contaminate the sterile field (CDC, October
13, 2020).\133\ Additionally, PAPRs should not be used in surgical
settings due to concerns that the blower exhaust and exhaled air may
contaminate the sterile field (CDC, April 9, 2021).
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\133\ There are some newly designed NIOSH-approved half-mask
elastomeric respirators that can not only protect the wearer, but
also provide adequate source control by filtering the wearer's
exhaled air that may contain harmful viruses or bacteria (NIOSH,
March 1, 2021).
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Paragraph (f)(3) addresses the provision and use of respirators and
other PPE during aerosol-generating procedures (AGPs) performed on
persons with suspected or confirmed COVID-19, which, under this
paragraph, includes AGPs performed on suspected or confirmed COVID-19
cases during autopsies. As defined in paragraph (b), an AGP is a
medical procedure that generates aerosols that can be infectious and
are of respirable size. The definition lists a number of types of
procedures that are considered to be AGPs for purposes of the ETS (see
below for additional discussion of the listed procedures). AGPs
performed on persons with suspected or confirmed COVID-19 are more
likely to generate higher concentrations of potentially infectious
respiratory aerosols than coughing, sneezing, talking, or breathing;
therefore, employees performing or assisting in the conduct of AGPs
performed on persons with suspected or confirmed COVID-19 are at an
increased risk for COVID-19 exposure and infection (CDC, March 4,
2021). Given the risks associated with AGPs performed on persons with
suspected or confirmed COVID-19, the ETS requires the provision and use
of respirators and other PPE when AGPs are performed on such persons. A
detailed discussion of OSHA's rationale for requiring employers to
provide and ensure the use of respirators and other PPE in these
circumstances is in the Need for Specific Provisions (Section V of the
preamble).
Development of a comprehensive list of AGPs for healthcare settings
has not been possible due to limitations in available data on which
procedures may generate potentially infectious aerosols and the
challenges in determining if reported transmissions during AGPs are due
to aerosols or other exposures (CDC, March 4, 2021). Furthermore, there
is neither expert consensus, nor sufficient supporting data, to create
a definitive and comprehensive list of AGPs for this ETS (CDC, March 4,
2021). For example, based on limited available data, it is uncertain
whether aerosols generated from some procedures, such as nebulizer
administration and high-flow oxygen delivery, may be infectious. More
specifically, aerosols generated by nebulizers are derived from
medication in the nebulizer, and it is uncertain whether potential
associations between performing this common procedure and increased
risk of infection might be due to aerosols generated by the procedure
or due to increased contact between those administering the nebulized
medication and infected patients (CDC, March 4, 2021).
Therefore, the only medical procedures that are considered AGPs for
the purposes of this ETS are: Open suctioning of airways; sputum
induction; cardiopulmonary resuscitation; endotracheal intubation and
extubation; non-invasive ventilation (e.g., BiPAP, CPAP); bronchoscopy;
manual ventilation; medical/surgical/postmortem procedures using
oscillating bone saws; and dental procedures involving ultrasonic
scalers, high-speed dental handpieces, air/water syringes, air
polishing, and air abrasion. Examples of procedures that are considered
AGPs under the ETS are a dentist or dental hygienist using an
ultrasonic scaler on a patient; a nurse intubating a patient; an
emergency medical technician (EMT) performing cardiopulmonary
resuscitation on a patient; and a coroner or medical examiner using an
oscillating bone saw during an autopsy. These and the other commonly
performed procedures listed above are considered AGPs because they
create uncontrolled respiratory secretions. They are also consistent
with those identified by the CDC as the most common AGPs in healthcare
settings (CDC, March 4, 2021; CDC, December 4, 2020; CDC, December 2,
2020).
Paragraph (f)(3) requires that for AGPs performed on a person with
suspected or confirmed COVID-19, the employer must provide: (i) A
respirator to each employee and ensure that it is provided and used in
accordance with the Respiratory Protection Standard (29 CFR 1910.134);
and (ii) gloves, an isolation gown or protective clothing, and eye
protection to each employee and ensure that the PPE is used in
accordance with the PPE standard (29 CFR part 1910, subpart I). These
requirements are similar to those in paragraph (f)(2), discussed above.
There are two notes to paragraph (f)(3). The first note provides
that, for AGPs performed on a person with suspected or confirmed COVID-
19, employers are encouraged to select elastomeric respirators or PAPRs
instead of FFRs. OSHA included this note in the regulatory text because
of the high risk associated with AGPs conducted on persons with
suspected or confirmed COVID-19. One published article explained why
filters certified as 99, 100, or HEPA (high-efficiency particulate
air), but not N95s, are appropriate for AGPs. Howard (May 12, 2020)
concluded that the correct selection of respirators for AGPs is ``of
the utmost importance in the current COVID-19 pandemic'' because
``high-risk aerosol-generating procedures may create aerosolization of
high viral loads that represent increased risk to healthcare workers.''
PAPRs provide a higher level of respiratory protection than N95
FFRs. PAPRs reduce the aerosol concentration inhaled by the wearer to
at least 1/25th of that in the air, compared to a 1/10th reduction for
FFRs (CDC, November 3, 2020). Because they provide higher-level
respiratory protection than N95 FFRs, the CDC encourages the use of
PAPRs during AGPs regardless of the pathogen (i.e., not just for
protection against COVID-19) (CDC, November 3, 2020). Furthermore, the
CDC encourages the use of PAPRs during autopsy procedures on deceased
persons who had COVID-19 due to the likelihood of generation of
contagious aerosols during various autopsy procedures (CDC, December 2,
2020).
Elastomeric respirators provide at least the level of respiratory
protection as N95 FFRs. Half-mask elastomeric respirators offer the
same level of protection as N95 FFRs (i.e., both N95 FFRs and half-mask
elastomeric respirators reduce the aerosol concentration inhaled by the
wearer to 1/10th of that in the air).\134\ Full-face
elastomeric respirators provide greater protection because of better
sealing characteristics and less face-seal leakage (and also provide
protection to more of the face including the eyes) (CDC, October 13,
2020). Full-face elastomeric respirators reduce the aerosol
concentration inhaled by the wearer to at least 1/50th of that in the
air (CDC, October 13, 2020).
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\134\ For more information on the minimum level of protection
that can be expected from any class of respirator (e.g., FFR, PAPR,
half-mask elastomeric respirator) when the respirator is properly
selected and used, see NIOSH/OSHA's (May 2015) Hospital Respiratory
Protection Program Toolkit at https://www.osha.gov/sites/default/files/publications/OSHA3767.pdf.
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The second note to paragraph (f)(3) is a reminder that additional
requirements, besides respirator requirements, specific to AGPs on
people with suspected or confirmed COVID-19 are contained in paragraph
(g). Additional information on paragraph (g) is discussed later in the
Summary and Explanation.
Paragraph (f)(4) addresses the optional use of respirators by
employees when not required by the ETS. OSHA recognizes that there will
be cases where either an employer or an employee believes that
protection is needed beyond the facemask required by paragraph (f)(1).
Therefore, under paragraph (f)(4)(i), the employer may upgrade an
employee's protection by providing a respirator to the employee when
only a facemask is required by paragraph (f)(1). For example, an
employer that operates a hospital may choose to provide, or an employee
may choose to wear, a respirator instead of a facemask where an
employee is performing administrative work in an area of the hospital
where there is no reasonable anticipation of exposure to persons with
suspected or confirmed COVID-19. Per paragraph (f)(4)(ii), where the
employer provides the employee with a facemask as required by paragraph
(f)(1) of the section, the employer must permit the employee to wear
their own respirator instead of a facemask. In both circumstances, the
employer must comply with the mini respiratory protection program
section of the ETS (29 CFR 1910.504). OSHA intends this flexibility,
combined with lowered administrative requirements, to encourage more
respirator use because properly worn respirators will provide
significantly improved protection from COVID-19. Again, for a detailed
discussion of the mini respiratory protection program section, please
see the relevant discussion in this Summary and Explanation and Need
for Specific Provisions (Section V of the preamble).
Paragraph (f)(5) addresses the provision and use of respirators and
other PPE based on Standard and Transmission-Based Precautions. Under
this paragraph, the employer must provide PPE (e.g., respirators,
gloves, gowns, goggles, face shields) to each employee in accordance
with Standard and Transmission-Based Precautions in healthcare settings
in accordance with CDC's ``Guidelines for Isolation Precautions,''
which is incorporated by reference into the ETS. The employer must also
ensure that the PPE is used in accordance with OSHA's PPE Standard, 29
CFR part 1910, subpart I. OSHA provides a more in-depth explanation and
discussion of Standard and Transmission-Based Precautions in the
relevant section of this Summary and Explanation, as well as Need for
Specific Provisions (Section V of the preamble).
References
Centers for Disease Control and Prevention (CDC). (2020, October
13). Elastomeric Respirators: Strategies During Conventional and
Surge Demand Situations. https://www.cdc.gov/coronavirus/2019-ncov/hcp/elastomeric-respirators-strategy/index.html. (CDC, October 13,
2020).
Centers for Disease Control and Prevention (CDC). (2020, November
3). Considerations for Optimizing the Supply of Powered Air-
Purifying Respirators (PAPRs). https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/powered-air-purifying-respirators-strategy.html. (CDC, November 3, 2020).
Centers for Disease Control and Prevention (CDC). (2020, December
2). Collection and Submission of Postmortem Specimens from Deceased
Persons with Confirmed or Suspected COVID-19: Postmortem Guidance.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-postmortem-specimens.html. (CDC, December 2, 2020).
Centers for Disease Control and Prevention (CDC). (2020, December
4). Guidance for Dental Settings: Interim Infection Prevention and
Control Guidance for Dental Settings During the Coronavirus Disease
2019 (COVID-19) Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/dental-settings.html. (CDC, December 4, 2020).
Centers for Disease Control and Prevention (CDC). (2021, January
11). NIOSH-Approved N95 Particulate Filtering Facepiece Respirators.
https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html. (CDC, January 11, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the coronavirus disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 4).
Clinical questions about COVID-19: questions and answers. Which
procedures are considered aerosol generating procedures in
healthcare settings? https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019
-ncov%2Fhcp%2Finfection-control-faq.html. (CDC, March 4, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 9).
Strategies for Optimizing the Supply of N95 Respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html. (CDC, April 9, 2021).
Howard, BE. (2020, May 12). High-Risk Aerosol-Generating Procedures
in COVID-19: Respiratory Protective Equipment Considerations.
Otolaryngol Head Neck Surg 163(1): 98-103. (Howard, May 12, 2020).
National Institute for Occupational Safety and Health (NIOSH).
(2021, March 1). Advancements in Elastomeric Respirator Technology
for Use as Source Control. https://blogs.cdc.gov/niosh-science-blog/2021/03/01/elastomeric_source-control/. (NIOSH, March 1, 2021).
National Institute for Occupational Safety and Health (NIOSH)/
Occupational Safety and Health Administration (OSHA). (2015, May).
Hospital Respiratory Protection Program Toolkit at https://www.osha.gov/sites/default/files/publications/OSHA3767.pdf. (NIOSH
and OSHA, May 2015).
F. Aerosol-Generating Procedures on Suspected or Confirmed COVID-19
Patients
As discussed in Need for Specific Provisions (Section V of this
preamble), aerosol-generating procedures (AGPs) are well-known to be
high-risk activities for exposure to respiratory infections. As such,
paragraph (g) addresses policies and procedures that employers must
implement to protect employees who perform AGPs on persons with
suspected or confirmed COVID-19. This includes aerosol-generating
postmortem procedures (e.g., autopsies) because human remains can still
produce infectious droplets and particles (i.e., ``person'' includes
``human remains'' for the purpose of paragraph (g)).
As defined in paragraph (b), AGPs are medical procedures that
generate aerosols that can be infectious and are of respirable size.
For the purposes of the ETS, only the following medical procedures are
considered AGPs: Open suctioning of airways; sputum induction;
cardiopulmonary resuscitation; endotracheal intubation and extubation;
non-invasive ventilation (e.g., BiPAP, CPAP); bronchoscopy; manual
ventilation; medical/surgical/postmortem procedures using oscillating
bone saws; and dental procedures involving ultrasonic scalers,
high-speed dental handpieces, air/water syringes, air polishing, and
air abrasion. For further information on why these procedures are
considered AGPs under the ETS, please see Need for Specific Provisions
(Section V of this preamble).\135\
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\135\ CDC guidelines recommend avoiding AGPs during postmortem
activities if possible. The guidelines also provide that, if aerosol
generation is likely and unavoidable (e.g., when using an
oscillating saw), appropriate engineering controls and PPE should be
used, and that these precautions, combined with the use of Standard
Precautions, will help prevent direct contact with infectious
material, percutaneous injury, and other hazards related to moving
human remains and handling embalming chemicals (CDC, December 2,
2020).
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If an AGP is performed on a person with suspected or confirmed
COVID-19, per paragraph (g)(1), the employer must limit the number of
employees present during the procedure to only those essential for
patient care and procedure support. This will ensure that as few
employees as possible are exposed to infectious aerosols.
As noted in Grave Danger (Section IV.A. of this preamble), COVID-19
may spread through airborne transmission during AGPs. To this end,
paragraph (g)(2) requires that when an AGP is performed on a person
with suspected or confirmed COVID-19, the employer must ensure it is
performed in an existing airborne infection isolation room (AIIR), if
available. An AIIR, under paragraph (b), is defined as a dedicated
negative-pressure patient-care room, with special air handling
capability, which is used to isolate persons with a suspected or
confirmed airborne-transmissible infectious disease. AIIRs include both
permanent rooms and temporary structures (e.g., a booth, tent or other
enclosure designed to operate under negative pressure). For further
discussion on the need for adequate ventilation and AIIRs during AGPs,
please see Need for Specific Provisions (Section V of this preamble)
and the Summary and Explanation for ventilation (paragraph (k)(2)).
There are a limited number of AIIRs available across the United
States, and the COVID-19 pandemic has created added demand for AIIRs
(Wilson, April 16, 2020). Based on this, OSHA concludes that the use of
AIIRs needs to be prioritized for those persons that present the
greatest exposure risk to employees (which, for the purposes of the
ETS, means those persons with suspected or confirmed COVID-19). OSHA's
decision to require the use of AIIRs only when AGPs are performed on
persons with suspected or confirmed COVID-19 is consistent with the
CDC's guidance on the use of AIIRs during AGPs (CDC, February 23,
2021).
If an AIIR is not available for an AGP on a person with suspected
or confirmed COVID-19 (because, for example, the facility does not have
an AIIR), the employer may transfer the patient to a facility with an
available AIIR, if feasible. Employers may also consider the use of a
ventilated headboard with a canopy if an AIIR is not available.
However, if the procedure must be performed in the facility that does
not have an available AIIR, the employer should still isolate the
person to the extent feasible and distance that person from others when
isolation is not feasible. For example, the employer could ensure that
the procedure is performed in an isolated area of the facility.
Moreover, the employer will need to comply with other provisions of the
ETS, as well as all other applicable OSHA standards, during the conduct
of the procedure (e.g., providing employees with and ensuring they use
respirators and other PPE in accordance with paragraph (f), and
complying with requirements for ventilation in paragraph (k)).
Paragraph (g)(3) requires that, after an AGP is performed on a
person with suspected or confirmed COVID-19, the employer must clean
and disinfect the surfaces and equipment in the room or area where the
AGP was performed. The employer must also develop and implement
policies and procedures in accordance with paragraphs (c) and (j) to
ensure prompt, proper cleaning and disinfection of the surfaces and
equipment in the room or area.
Finally, a note to paragraph (g) provides that respirator and other
PPE requirements for use during AGPs are contained in paragraph (f)(3).
This note serves as a cross-reference.
References
Centers for Disease Control and Prevention (CDC). (2020, December
2). Collection and Submission of Postmortem Specimens from Deceased
Persons with Confirmed or Suspected COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-postmortem-specimens.html. (CDC,
December 2, 2020).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim Infection Prevention and Control Recommendations for
Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Wilson, M. (2020, April 16). Negative pressure rooms save lives. Why
aren't there more of them? Fast Company. https://www.fastcompany.com/90491094/negative-pressure-rooms-save-lives-why-arent-there-more-of-them. (Wilson, April 16, 2020).
G. Physical Distancing
The virus that causes COVID-19 spreads mainly through droplet
transmission between people who are in physical proximity to each
other. Adequate physical distancing to prevent droplet transmission of
infectious diseases is generally considered to be at least 6 feet, as
addressed under Need for Specific Provisions (Section V of the
preamble). Therefore, paragraph (h)(1) requires employers to ensure
that each employee is separated from all other people by at least 6
feet when indoors. In cases where the employer can demonstrate that
maintaining 6 feet of physical distance is not feasible for a specific
activity, paragraph (h)(2) requires the employer to ensure that each
employee is as far apart as feasible from all other people in the
workplace. The requirements of paragraph (h) do not apply to momentary
exposure while people are in movement, such as when coworkers pass each
other in a hallway. However, this exception has important limits, as
discussed further below.
Paragraph (a)(4) provides one notable exception to the physical
distancing requirements of paragraph (h) for employees who are fully
vaccinated when those employees are in well-defined areas where there
is no reasonable expectation that any person with suspected or
confirmed COVID-19 will be present. When those conditions are
satisfied, the fully vaccinated employees are not required to maintain
6 feet of distance from any other people. By operation of this
exception, employees who are not fully vaccinated are not required to
maintain 6 feet of distance from any fully vaccinated employee;
however, they must continue to follow distancing requirements as to all
other persons because employers may not be able to confidently
ascertain the vaccination status of non-employees. This exception might
arise, for example, if an employer provides a training or holds a
conference for its employees in a conference room where no patients or
persons with suspected or confirmed COVID-19 will be present. In that
example, the employer is not required to keep vaccinated employees
separate from any other people by 6 feet; however, if employees in
attendance are not fully vaccinated, the employer would be required to
ensure that the unvaccinated employees maintain sufficient physical
distance from all people other than the fully vaccinated employees,
such as other non-employee attendees, trainers, or conference
presenters. In another example, where
there is an employee breakroom, any employee who is fully vaccinated
would not be required to maintain physical distancing from any other
persons while using the breakroom. Again, however, any employee who is
not fully vaccinated would still be required to maintain at least 6
feet of distance from any persons other than their fully vaccinated co-
workers who might enter the space. In order for fully vaccinated
employees to be exempt from the requirement for physical distancing in
accordance with paragraph (a)(4), paragraph (c)(4)(ii) of the standard
requires the employer's COVID-19 plan to include policies and
procedures for determining employees' vaccinations status. For further
explanation of the exception for fully vaccinated employees from some
requirements of the ETS, see the Summary and Explanation discussion of
paragraph (a)(4), above.
Employers must rely on the results of the hazard assessment
performed under paragraph (c)(4) to determine when and where physical
distancing is necessary in the workplace. The hazard assessment
requires employers to evaluate their workplaces to determine potential
workplace hazards related to COVID-19. This evaluation will involve
determining when, where, and under what circumstances employees come
within 6 feet of other people during the course of their workdays or
work shifts. After identifying where this is occurring, employers must
then implement, per their COVID-19 plans, policies and procedures to
comply with the physical distancing requirements in paragraph (h).
To comply with the physical distancing requirements of the ETS,
employers must ensure there is at least a full 6 feet of distance
between each employee and any other person, such that neither person's
body intrudes into that 6 feet of space. The employer must evaluate
situations where employees are expected to come close to any other
individuals, including coworkers, patients or residents, visitors,
delivery or repair persons, and any other people present at the
workplace. Employers must also consider all areas accessed by employees
when determining how to implement the physical distancing requirements.
To be in compliance, an employer must ensure that 6 feet of distance
can be maintained when employees are: At their workstations, whether
they are fixed or mobile; arriving at and leaving a worksite; traveling
within a worksite to their designated workstations; using locker rooms
to change in and out of work clothing or PPE; using restroom facilities
and break areas; and otherwise performing their work duties and
activities incidental to those duties. (OSHA notes, however, the
exception for fully vaccinated employees in certain well-defined areas,
discussed above.)
The note to paragraph (h) describes several ways employers can
implement physical distancing that would be in compliance with this
standard. OSHA recognizes that the provided list of examples is not
exhaustive and that some options may be infeasible in some workplace
settings. The agency also recognizes that physical distancing policies
will need to be specific for each workplace. The note to the physical
distancing provision is simply meant to provide a brief list of some of
the primary options for physical distancing that employers are expected
to consider in determining how to comply. For example, if an employee's
job activities can be completed entirely remotely, then physical
distancing could be easily maintained through telework or other remote
work arrangements. Employers should maximize their reliance on telework
or remote work whenever possible.
When employees have job activities that must be done on-site or on-
location, other physical distancing approaches will be required. To
comply with physical distancing requirements, employers may need to
reconfigure workstations. Workstations could be spread out or relocated
to more spacious areas to ensure that employees at the workstations are
at least 6 feet away from each other. Workstations near high-traffic
areas may need to be moved to places with less foot traffic if physical
distance cannot be maintained.
Shared workstations (e.g., security checkpoints, nursing stations)
may also need to be reconfigured to ensure physical distancing can be
maintained. However, for shared workstations that require extended use
over the course of a workday, it may be useful to schedule when
employees can use those stations by adjusting the timing of their use
or providing alternative locations. In settings where security
checkpoints are used, stations can be spread farther apart or
additional, unused desks can be utilized. Similarly, individual
workspaces at nursing stations can be spread farther apart, and visual
cues can be used to ensure nurses and other healthcare employees remain
6 feet apart when communicating.
For workplaces that utilize shift work, minimal-contact shift
changes, in which employees maintain at least 6 feet of distancing
during shift turnover, can be considered. For these shift transitions,
detailed notes, virtual communications, and virtual oversight could be
substituted for in-person contact to help ensure important information
is not overlooked. Shift changes at healthcare facilities that involve
a large number of people may be particularly challenging in terms of
physical distancing. At these times, many employees may be entering or
leaving through a limited number of doors or using the same equipment
to clock in or clock out. It may also be foreseeable that weather
conditions (e.g., rain, heat, cold) could result in employees
congregating at facility entrances and exits. In these situations,
employers can consider permitting employees to utilize additional entry
or exit points, installing additional time clock equipment, or
staggering arrival and departure times to limit employee interactions.
Visual cues, such as signs or floor markings, can be utilized in
parking lots, sidewalks, lobbies, and other walking areas to designate
clear entry and exit routes and to remind employees and non-employees
to remain physically distant, especially during high-traffic times of
the day.
Employers can also consider adjusting work processes to achieve
physical distancing. If workstations and work processes cannot be
physically rearranged in a way that allows 6 feet of distance at all
times, employers must consider additional measures, such as reducing
capacity and occupancy limits or altering work procedures. The
following measures could help ensure compliance with paragraph (h):
Limiting the types of services provided; limiting occupancy in the
establishment; installing visual cues (e.g., signs and floor markers)
to remind employees and others to maintain 6 feet between individuals;
enforcing one-way traffic flow; and using verbal public service
announcements to remind employees and non-employees to practice
physical distancing.
Changing work procedures and utilizing available technologies can
also minimize or eliminate the necessity for close physical proximity
between employees and other people. For example, employers may
implement contactless transaction methods through mobile devices for
payments, signing documents, and pick-up and/or delivery confirmations.
Similarly, employers can consider adopting policies for booking
appointments by phone or online, curbside pickup, and drive-through
options to reduce the need for contact with customers or patients.
Phones or other visual recording and streaming devices may also be
useful in some facilities to perform physically-distanced equipment and
safety
inspections. Employers could maximize the use of telehealth to consult
with patients and clients through phone or video visits, where
appropriate.
Subject to the exception for fully vaccinated employees in well-
defined areas where there is no reasonable expectation that any person
with suspected or confirmed COVID-19 will be present, employers must
also ensure that employees maintain physical distancing during
meetings, trainings, and conferences. This could be achieved through
the use of additional rooms to decrease group sizes or by scheduling
these activities to occur virtually. When on-site or hands-on training,
such as specialized equipment training, is necessary, employers could
consider holding one-on-one sessions instead of large group sessions to
minimize exposure risk. An employer could also consider offering
activities at multiple times to decrease the number of attendees in
each session.
If ensuring physical distancing in compliance with paragraph (h)(1)
is not feasible given how work is currently scheduled, employers can
consider staggering work shifts. This would result in fewer people in
the workplace at a time, which should facilitate physical distancing.
Employers can also consider scheduling employees for fewer, longer
shifts instead of shorter, more-frequent shifts to minimize employee
turnover within the facility.
Unless the exception for fully vaccinated employees in certain
well-defined areas applies, employers must also pay attention to
physical distancing during break times and within common areas where
employees normally congregate (e.g., nursing stations, locker rooms).
To maintain physical distance, employers may decide to replace or add
to existing break areas by using training or conference rooms that
provide more space for employees to spread out. Also, tables and chairs
may be spaced out, removed, or blocked off to limit occupancy and
create distanced seating arrangements. Chairs could be placed 6 feet
apart and only on one side of a table to ensure employees are not
facing each other while eating. An employer could also stagger break
times to reduce the number of employees using those spaces at any one
time.
Also, where the exception in paragraph (a)(4) does not apply,
physical distancing must be implemented in workplace restrooms and
locker rooms. Some sinks, urinals, and stalls may need to be closed or
blocked off to ensure adequate space is maintained. There may be
certain times, such as during breaks, when the number of users
outnumbers the facilities available given the imposition of the
distancing requirement. Employers may find that additional restrooms or
queues outside of restrooms are needed to ensure that an appropriate
number of individuals are inside each restroom and that physical
distance is maintained outside of those spaces. If queues are needed,
visual floor markers may be useful to reinforce physical distancing
requirements. If restrooms have lounge areas, removing lounge furniture
can prevent people from congregating. In small facilities, employers
may have to limit access to a small restroom to only one person at a
time to maintain physical distancing.
As stated in paragraph (h)(1), physical distancing is not required
for momentary exposures while people are in movement. As discussed
further in the Need for Specific Provisions (Section V of the
preamble), an employee generally needs to be both close enough to an
infectious person and near them long enough to get an infectious dose
of COVID-19. The time of exposure is cumulative; multiple short
exposures over the course of a day can add up to a long enough period
of time to receive an infectious dose of the virus. Therefore, OSHA
interprets this exception for momentary exposures as applying only in
situations where the momentary exposures happen on an infrequent or
occasional basis. If an employee quickly passes another person in a
hallway or aisle a few times a day, the distancing requirement of
paragraph (h)(1) would not apply. On the other hand, physical
distancing requirements would be required for short conversations in a
hallway or at a work station, as well as in other situations involving
frequent, brief contact.
Similarly, the exception for momentary exposures in paragraph
(h)(1) does not apply to two employees in a workplace who repeatedly
pass by each other to perform their tasks. For example, physical
distancing (from employees and non-employees alike) is required where
employees are regularly moving around to check on patients. If
employees must pass each other repeatedly during a shift, the employer
must ensure employees maintain a physical distance of 6 feet in
accordance with the standard.
Paragraph (h)(2) applies if an employer can demonstrate that it is
not feasible to maintain 6 feet of physical distance for a certain
activity. In such cases, paragraph (h)(2) requires employers to ensure
that the employee is as far apart from all other people as feasible.
The requirement in paragraph (h)(2) recognizes that, even where 6 feet
of distance cannot be maintained, keeping as much distance between
people as possible can help lower the possibility of transmission of
COVID-19, especially when combined with the other protections required
by the ETS.
Paragraph (h)(2) acknowledges that there will be situations in some
workplaces in which maintaining 6 feet of distance at all times is not
possible. For example, there may be situations where a room or other
workspace is less than 6 feet in length and width and two employees
must be in it at one time. This could include spaces in vehicles, such
as emergency responders in an ambulance. If the employer can
demonstrate that the space cannot be expanded, and that both employees
must be in that space at the same time (i.e., that there are no other
feasible alternatives that would permit 6 feet of physical distancing),
the employer satisfies its burden under paragraph (h)(1) to demonstrate
infeasibility. The employer would then be required, pursuant to
paragraph (h)(2), to ensure that as much distance as possible is
maintained between the two employees in that space. The ETS also
generally requires the employer to ensure the use of physical barriers
at fixed work locations outside of direct patient care areas where each
employee is not separated from all other people by at least 6 feet (see
paragraph (i)) and the use of facemasks or respirators (see paragraph
(f)).
Maintaining physical distance between a healthcare provider and
patient is not always feasible when conducting an in-person exam or
providing medical treatment, particularly within a small exam room.
However, it is more likely that physical distance of 6 feet can be
maintained when healthcare providers are asking patients questions
about their medical history or problems they are experiencing. Again,
the agency requires employers to ensure 6 feet whenever possible.
However, employees who provide medical care will also be protected by
other aspects of the ETS, including the use of facemasks or respirators
and other PPE, depending on the circumstances, and cleaning and
disinfection requirements (see paragraphs (f) and (j), respectively).
Other job duties that may require employees to be within 6 feet of
others include patient transport, operations security, multi-person
maintenance tasks, and confined space work. Physical distancing of 6
feet may be difficult to maintain at all times in constricted areas,
even after the employer has reallocated work tasks or redesigned
workflow to maximize distancing. In all cases, the burden is on
the employer to demonstrate that it is infeasible to comply with the
required physical distancing for a specific activity. And in such
cases, employers must ensure that employees maintain as much physical
distance as feasible under paragraph (h)(2) and that physical
distancing is layered with the other means of protection required by
this standard (e.g., facemask use, cleaning and disinfection,
installation of physical barriers).
Physical distancing may also be challenging to maintain at a shared
worksite or shared facility. In such a case, coordination with other
employers will be critical to determining when and where employees
should perform their tasks at the site. Also, as noted previously with
reference to emergency responders in an ambulance, when employees
operate or ride in work vehicles with other people in them (e.g.,
ambulances, shuttle buses), it might not always be possible to maintain
6 feet of distancing. Employers must first consider reducing capacity
in the vehicle to allow for 6 feet of physical distancing under
paragraph (h)(1). When that is not feasible, employers must ensure that
employees maintain as much distance as possible while in the vehicle
(paragraph (h)(2)).
Although paragraph (h)(1) requires employers to ensure physical
distancing of at least 6 feet, respiratory droplets may at times be
capable of traveling across longer distances, as discussed further in
Grave Danger (Section IV.A. of the preamble). However, as explained in
the Need for Specific Provisions (Section V of the preamble), COVID-19
infections require exposure to a certain quantity of viral particles,
and exposures beyond 6 feet involve exposure to fewer particles.
Therefore, OSHA has concluded that a distance of 6 feet sufficiently
minimizes viral transmission in conjunction with the other aspects of
the layered infection control approach required under this ETS. While
the agency requires that employers, at a minimum, ensure 6 feet of
distance between people in the workplace, the agency also recommends
that employers implement physical distancing of more than 6 feet
whenever possible.
H. Physical Barriers
Physical barriers intercept respiratory droplets, which can contain
COVID-19, and prevent them from being transmitted from person to
person. As such, physical barriers are an important component of this
ETS when workers cannot be separated from all other people by at least
6 feet. Paragraph (i) requires barriers to be installed at each fixed
work location outside of direct patient care areas where each employee
is not separated from all other people by at least 6 feet of distance,
except where the employer can demonstrate it is not feasible to install
the barrier.
Paragraph (a)(4) provides an exception to the physical barrier
requirements of paragraph (i) for employees who are fully vaccinated
when those employees are in well-defined areas where there is no
reasonable expectation that any person with suspected or confirmed
COVID-19 will be present. When those conditions are satisfied, barriers
are not required to separate fully vaccinated employees from those who
are not fully vaccinated. Barriers must be provided in accordance with
paragraph (i) to separate employees who are not fully vaccinated from
other employees who are not fully vaccinated and all non-employees
because employers will not be able to confidently ascertain the
vaccination status of non-employees. In order for fully vaccinated
employees to be exempt from the requirement for physical barriers in
accordance with paragraph (a)(4), paragraph (c)(4)(ii) of the standard
requires the employer's COVID-19 plan to include policies and
procedures for determining employees' vaccinations status. For further
explanation of the exception for fully vaccinated employees from some
requirements of the ETS, see the Summary and Explanation discussion of
paragraph (a)(4), above.
In paragraph (i), the barriers must be sized (e.g., height, width)
and located so that they block face-to-face pathways between the
employee and other individuals, based on where each person would
normally stand or sit. If necessary, barriers may have a pass-through
space at the bottom to be used to pass items from one side of the
barrier to the other. In healthcare and healthcare support services,
physical barriers are not required in patient care areas or resident
rooms, as stated in the note to paragraph (i).
Fixed locations where barriers may be required under paragraph (i)
include entryways, lobbies, check-in desks, admission desks, screening
sites, intake and triage areas, hospital pharmacy windows, security
guard stations, and bill-payment counters; again, barriers would only
be required for these work locations where physical distancing cannot
be achieved. For example, a barrier may be required at a bill-payment
counter if employees or visitors are not able to maintain 6 feet of
physical distancing while at the counter.
As noted following paragraph (i), physical barriers are not
required in direct patient care areas, such as treatment rooms,
examination rooms, and resident rooms in hospitals, long-term care
facilities, rehabilitation facilities, hospice facilities, or other in-
patient healthcare facilities. Direct patient care, as defined in
paragraph (b), is hands-on, face-to-face contact with patients for the
purpose of diagnosis, treatment, and monitoring. The CDC does not
recommend the installation of barriers between healthcare professionals
and their patients during direct patient care, so OSHA is not requiring
them, even when they might be feasible. Employers in healthcare may
consider installing barriers in direct patient care areas if
appropriate. However, in areas where direct patient care is not
provided, barriers are required when individuals cannot maintain at
least 6 feet of physical distancing under this provision.
As part of the hazard assessment under paragraph (c)(4), employers
need to determine which job activities and fixed work locations require
physical barriers. This involves a determination, for each fixed work
location, of whether the employee(s) at that work location can be
separated from other people by at least 6 feet of distance. The
implementation of physical barriers in the workplace, including how
many are needed, where they are needed, and how they should be
installed, may vary with the size and type of the workplace, along with
the work activities performed there. As such, the provision that
requires physical barriers is presented in a manner that gives the
employer flexibility to adapt the design, location, size, and materials
of physical barriers to specific workplace conditions, policies,
procedures, tasks, and layouts, as well as state and local legal
requirements such as zoning and fire codes. Despite this performance
language, employers must ensure that the barriers are installed when
and where they are required, in accordance with paragraph (i), and that
the barriers meet the other criteria in the provision, including those
for material, location, and size.
Physical barriers are only required for fixed work locations
outside of direct patient care areas when an employee is not separated
from all other people by at least 6 feet of distance. A fixed work
location is a workstation where an employee is assigned to work for
significant periods of time, or at which the employee spends much of
their workday or shift, even if they leave that workstation
intermittently as part of their work. Although the employee may
be required to move away from that fixed location to perform their job,
in many cases they would be required to return to the fixed location
throughout the day. Under paragraph (i), physical barriers are not
required at non-fixed workstations. In healthcare settings, examples of
non-fixed workstations may include when employees must move from
patient-to-patient within a waiting room or check-in area to complete
screening procedures. However, if these employees return to a central
desk to complete the check-in process or to enter information into a
computer for multiple patients, that desk would be considered a fixed
work location and would require a barrier. Barriers are also not
required in common areas where employees would pass each other, such as
hallways or break areas, as these are not fixed workstations.
To be effective, barriers must prevent droplets from passing
through them. Therefore, paragraph (i) requires barriers to be solid,
meaning they must be impermeable to the droplets that are expelled when
an individual is sneezing, coughing, breathing, talking, or yelling.
The employer must immediately repair or replace a barrier if it becomes
damaged. Examples of solid physical barriers include clear plastic or
acrylic partitions and sneeze guards, as well as temporary or permanent
walls. In some situations, flexible, transparent plastic sheeting can
qualify as a solid physical barrier, but only if it remains in place
and blocks face-to-face pathways of air between the users on either
side. It is critical that barriers block face-to-face pathways and that
they do not flap or otherwise move out of position when they are being
used. For example, if flexible plastic sheeting is installed between
employees, but the sheeting could easily be swept out of the way in the
course of an employee's work tasks or by ventilation, it would not
comply with this provision. However, employers may use flexible plastic
sheeting if it is installed in a manner such that it remains stationary
and is unlikely to be disturbed during use enough to allow droplets to
pass through that area (e.g., plastic sheeting hung between employees
and anchored--directly or via taut tethers or other devices--to a
surface to prevent movement), or the sheeting is weighted or affixed to
the ceiling and floor (or other fixture) to prevent its movement and
improve stability.
In accordance with paragraph (i), barriers must be made from
materials that can be easily cleaned and disinfected. Replacement is
also acceptable in lieu of cleaning. Since these barriers are
intercepting respiratory droplets that may contain COVID-19, it is
important to clean them frequently. Impermeable materials like plastic
or acrylic are easy to clean and disinfect. Cleaning and disinfection
of physical barriers should occur in accordance with requirements in
paragraph (j). This includes cleaning physical barriers at least once a
day, as well as disinfecting physical barriers if there has been a
COVID-19 positive person present in the workplace. Cleaning and
disinfecting products should be chosen to be compatible with the
barrier material used. If the cleaning and disinfecting products
selected are not compatible with the barrier material, the barrier may
become damaged and would then need to be replaced.
Where appropriate, barriers may be made of easily replaceable
materials, such as flexible, clear plastic sheeting. Using replaceable
materials would allow an employer to dispose of and replace barriers
between uses, instead of cleaning and disinfecting more permanent
barriers. Barriers constructed out of materials like cloth fabric or
mesh would not comply with paragraph (i); these materials are not
impermeable and would allow respiratory droplets to pass through them.
Employers must design and install physical barriers in a manner
that ensures that, given their positioning, height, and width, the
barriers can effectively prevent droplet transmission. Essentially, the
barriers must be designed and installed such that any person cannot
cough, talk, or breathe on an employee when the employee is in their
normal sitting or standing location relative to the workstation.
Therefore, the effective design and implementation of physical barriers
will differ between workplaces based on job tasks, work processes, and
even potential users.
As noted above, paragraph (i) requires barriers to be sized and
located so that they block face-to-face pathways between individuals
effectively, based on where each person would normally sit or stand.
When the individuals on both sides of the barrier will be sitting, the
barrier must be high enough, and extend far enough, to block face-to-
face pathways between those seated individuals effectively. To ensure
compliance with the size and location requirements, employers must
account for where the breathing zones of the users on both sides of the
barrier will likely be, as a barrier is only effective at reducing an
employee's exposure to COVID-19 if it keeps respiratory droplets out of
the employee's breathing zone. As described in the Need for Specific
Provisions (Section V of this preamble), OSHA defines the breathing
zone as the area from which a person draws air when they breathe; it
extends 10 inches beyond a person's nose and mouth. The location of
that breathing zone is critical to designing compliant barriers because
of the requirement that barriers block face-to-face pathways between
the individuals on both sides of the barriers.
The height of employees and other individuals separated by barriers
impacts where their breathing zones will be located, as does whether
those individuals will be sitting or standing when at the fixed work
location. These factors must, therefore, be taken into account when
determining the size and location of each barrier in order to comply
with paragraph (i). If employers are certain that only specific
employees will be at a particular fixed workstation and will not be
exposed to other people (e.g., visitors) of varying heights, then the
barrier can be tailored to those factors (i.e., employers can tailor
the barrier height to the height of the employees that use that
particular workstation). However, in the vast majority of cases, the
heights of employees and visitors will vary and, and employers must
construct their barriers to at least address average heights. The
average height of adults in the US is 63.6 inches for women and 69
inches for men (CDC, May 20, 2020). Employers should consider the
height of typical users and their breathing zones to design and install
barriers in a way that ensures face-to-face pathways are effectively
blocked. Note that OSHA is not mandating a specific barrier height and
enforcement will focus on whether the barrier blocks the breathing
pathway.\136\ For example, for employers who do not know the heights of
the people who are likely to be separated by a barrier, OSHA will
accept as compliant a barrier that extends to at least 6 and a half
feet above the surface on which both people are standing, as this would
block face-to-face transmission at the average heights for both females
and males while also accounting for their breathing zones. Depending on
the job tasks, workstation design, and typical user height, barriers
may be able to be shorter (e.g., if both users are sitting) or may need
to be taller (e.g., a person is standing on an elevated surface) to
ensure that they block face-to-face pathways between users.
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\136\ In the absence of observable interactions at the barriers,
or evidence that the barrier is only used to separate specific
persons of known heights, OSHA's enforcement will focus on whether
the employer has installed the barriers for the average heights.
---------------------------------------------------------------------------
If the barrier is installed on a table, desk, countertop, or other
surface above floor height, the height of those items would be included
in the barrier height. If one user may be sitting and the other may be
standing, barriers should be high enough to reflect the height of the
standing user as well as the sitting user. The average sitting height
of users will vary based on chair height and type, and employers should
consider the workstation design when implementing physical barriers. If
employees utilize sit-and-stand workstations, barriers would need to be
designed to block face-to-face pathways of employees in both sitting
and standing positions. If that is not possible, employers should
consider suspending the use of sit-and-stand workstations during the
pandemic.
To meet the requirement for the barrier to be sized (e.g., height
and width) and located to block face-to-face pathways based on where
individuals would normally stand or sit, the physical barrier must
extend far enough along the workstation to fully contain respiratory
droplets that are expelled during sneezing, coughing, breathing,
talking, or yelling. In addition to being sufficiently tall, barriers
need to be wide enough to protect users on either side during the
entire interaction. To ensure compliance, employers also need to
consider predictable behaviors and movements of employees and non-
employees when designing and installing barriers. The part of paragraph
(i) that refers to where each person would normally stand or sit is
meant to ensure employees are protected in the event users behave in a
way that would reduce the effectiveness of the physical barriers, such
as moving to the side of, around, or above the barrier. If such
behaviors are predictable, and are not taken into account when
designing the barrier, the barrier would not be compliant.
For example, at a service counter, the barrier must be wide enough
to block the face-to-face pathway between an employee and a visitor
when the employee and visitor are positioned directly across from each
other. In situations where the employee and the visitor are positioned
diagonally across from each other but still within 6 feet, the barrier
must still extend to block those diagonal face-to-face pathways.
Barriers do not need to block all of the face-to-face pathways
while employees are briefly moving between the fixed workstations. For
healthcare check in areas, a barrier would likely be necessary to
separate employees from non-employees at reception desks or other in-
take stations where payments are required. Barriers must extend far
enough to cover the area where credit card machines are located to
ensure that both users' breathing zones are behind the barrier during
the entire transaction and to avoid users moving around the barrier at
any point during the transaction. If the visitor has to move away from
that barrier to access a credit card machine in a manner that would
result in a face-to-face pathway between the customer and cashier, the
barrier must extend to block those pathways. Employers should also
consider visual reminders, like floor markings or signs, to remind
employees and non-employees not to step around or move to the side of
or above the barrier when interacting with an employee. Additionally,
when designing barrier placement and implementation, employers should
consider if and how the barrier could alter communication between
users. If a barrier is required, but may interfere with effective
communication between individuals (e.g., when working with individuals
who are hard-of-hearing, when working in an environment with
significant background noise), electronic communication devices could
be installed. Slotted speaking grates should not be installed in the
barrier, as this would allow droplets to pass through the barrier.
Paragraph (i) allows the barrier to have a pass-through space at
the bottom for objects. This limited exception to the requirement for
the barrier to be solid applies when employees or others need to pass
items to someone on the other side of a barrier. For example, when
health screening is utilized at a healthcare facility, to screen either
employees or non-employees before entry, a barrier could be installed
to separate the employee conducting the screening from other
individuals. A small pass-through space could be used to facilitate the
passing of items between users, such as medical screening
questionnaires or COVID-19 testing materials. Such openings should be
as small as possible for the given job tasks and activities, and
openings should not be placed in front of the breathing zone of any
user.
The employer needs to consider the positioning of the individuals
on both sides of the barrier before determining where the pass-through
space should be located. For example, if a standing user is required to
pass items to a seated user on the other side, the pass-through space
must not be placed in front of either user's breathing zone. Instead,
the opening could be installed to the side of the seated individual. In
situations where the barrier extends to the floor, the pass-through
space may be located in the middle of the barrier, as long as it is
below or to the side of the breathing zones of both users and still
effectively blocks face-to-face pathways.
In some cases, when the items being transferred are large, a
sliding door may be installed to ensure the effectiveness of the
barrier. If a sliding door is used, it must be kept closed except when
necessary to transfer an item. As an alternative, work processes can be
established to take turns placing and picking up large items from a
location to the side of a barrier in order for users on either side of
the barrier to maintain 6 feet of physical distance. In addition,
employers must ensure that this high-touch surface is cleaned
frequently, in accordance with paragraph (j).
Physical barriers are typically mounted on hard surfaces or
designed to be free-standing. However, there may be circumstances where
an employer may decide to utilize a hanging barrier, depending on the
surface below or the work tasks being completed. Barriers may be hung
from above, such as from the ceiling or other fixture, as long as they
remain stationary and are unlikely to be disturbed during use. Barriers
that sway back and forth or do not fully block face-to-face pathways,
whether attached from below or hung from overhead, would not comply
with this provision. Hanging barriers may also be appropriate in
situations where pets or children may be present, such that alternate
barrier installations present safety hazards or risks related to
barriers falling down. Where hanging barriers are used above a counter
or other surface that is raised above the floor, they should extend
down as close to that surface as possible, allowing a space for passing
items where necessary. If barriers are hung from the ceiling but do not
fully extend to the floor or counter, policies should be developed to
ensure employees are not placing personal items (e.g., backpacks,
umbrellas, cellphones) on the floor or counter below the barrier where
they could be contaminated by droplets that land under the barrier. For
the same reason, employers must ensure that the surface below the
barrier is frequently cleaned in accordance with the cleaning and
disinfection provisions in paragraph (j).
While barriers provide protection to employees from COVID-19, their
design and installation must also consider employee safety. In the
event of an emergency, employees must be able to quickly leave their
work area, with their entry and exit not hindered by a physical
barrier. Building and fire safety should be considered when installing
barriers. Barriers must not block safety features, such as smoke
detectors, sprinklers, carbon monoxide detectors, fire extinguishers,
or fire alarms. Employers must properly secure large barriers that
could fall and injure an employee. Depending on the size and placement
of the barrier, temporary adhesive may be necessary to keep the barrier
securely in place. If barriers are mounted on floors, employers should
ensure barriers do not present trip-or-fall hazards to employees.
Ventilation should also be considered to ensure that the air in one
workspace is not funneled around a barrier and directly into another
person's workspace.
Barriers serve as a particularly important control when employees
are exposed to many different people, each a potential carrier of
COVID-19, and the barriers must be provided at fixed workstations even
if the employee also has tasks that cannot be performed behind the
barrier. The barrier can still reduce the duration of exposure and
potentially also the number of sources of exposure the employee faces
in the workplace. During these scenarios, barriers are not required
when the employee moves away from their fixed workstation, but the
other controls required by this standard, such as face masks, physical
distancing, and cleaning shared equipment play a vital role in reducing
employee exposure. Further, in these types of circumstances, employers
must also consider additional controls, such as rearranging work flow
to minimize the time an employee has to spend outside of the barrier,
or reducing the number of employees at non-fixed workstations at a
time, to ensure that the other protections required by the ETS are
implemented to the extent feasible.
OSHA also recognizes that some employees may have locations that
they go to frequently but may not qualify as a fixed workstation due to
the employee's frequent movement throughout the workplace during their
work day or shift, and thus physical barriers would not be required.
Under paragraph (i), employers are exempt from compliance with the
requirement to install physical barriers when the employer can
demonstrate that the use of barriers is infeasible. Barriers may not be
feasible during certain tasks that require multiple employees to work
cooperatively within 6 feet of one another in a fixed location for an
extended period of time. There may be some work settings where two
employees must ride in a shared work vehicle and operate shared
controls, such as in an ambulance, where barriers would also be
considered infeasible as they would be too difficult to install or
would block access to the shared controls that both employees need to
access. Finally, the agency notes that where barriers are infeasible,
it is particularly important to implement the other controls required
by this standard, such as facemasks and cleaning and disinfecting are
critical to the layered approach of the ETS in reducing employee
exposure.
Please see the Technological Feasibility section for additional
information about barrier installations in different scenarios.
References
Centers for Disease Control and Prevention (CDC). (2020, May 20).
Body Measurements. ttps://www.cdc.gov/nchs/fastats/body-measurements.htm. (CDC, May 20, 2020).
I. Cleaning and Disinfection
Hand hygiene removes germs from hands, while cleaning and
disinfecting surfaces removes harmful contaminants from surfaces.
Proper hand hygiene, combined with routine cleaning and situational
disinfecting of surfaces, minimizes the risk of COVID-19 transmission
through contact with contaminated surfaces. Therefore, the provisions
under paragraph (j) include cleaning and disinfection requirements for
the workplace. Requirements include cleaning high-touch surfaces and
equipment at least once a day, cleaning and disinfecting areas with
suspected COVID-19 contamination, and providing employees with readily
accessible hand washing facilities or alcohol-based hand rub. The
cleaning and disinfection requirements in this ETS are in addition to
employers' obligations under OSHA's sanitation standards (29 CFR
1910.141, 1926.51, 1928.110). Because the sanitation standards address
workplace hazards other than COVID-19, employers must continue to
comply with their obligations under those standards.
The CDC recommends cleaning surfaces, using soap and water or
detergent, to remove germs, dirt, and impurities (CDC, April 5, 2021).
As defined in paragraph (b), clean (or cleaning) means the removal of
dirt and impurities, including germs, from surfaces using soap and
water or other cleaning agents. Cleaning alone reduces germs on
surfaces by removing contaminants and may also weaken or damage some of
the virus particles, which decreases risk of infection from surfaces.
When no people with confirmed or suspected COVID-19 are known to have
been in a space, cleaning once a day is usually sufficient to remove
virus that may be on surfaces. To kill any additional germs on
surfaces, disinfecting, in addition to cleaning, may be needed. As
defined in paragraph (b), disinfect (or disinfection) means using an
EPA-registered, hospital-grade disinfectant on EPA's ``List N,'' in
accordance with manufacturers' instructions to kill germs on surfaces.
EPA's ``List N,'' which is incorporated by reference in 29 CFR
1910.509, is a list of disinfectant products that can be used against
the virus that causes COVID-19, including ready-to-use sprays,
concentrates, and wipes (EPA, April 9, 2021). When used in accordance
with manufacturers' instructions, EPA-registered disinfectants selected
from List N are expected to kill the virus that causes COVID-19.
Manufacturers' instructions include directions on the product's
appropriate use site (e.g., home, business, healthcare), surface type
(e.g., hard, non-porous surfaces like countertops; porous surfaces like
fabrics) and contact time (i.e., the time the product needs to be
visibly wet).
Under paragraph (j)(1), in patient care areas, resident rooms
(e.g., in-patient long-term care residences, rehabilitation facilities,
hospice facilities, other in-patient healthcare facilities), and for
medical devices and equipment, an employer must follow standard
practices for cleaning and disinfection of surfaces and equipment.
These standard practices must be in accordance with ``CDC's COVID-19
Infection Prevention and Control Recommendations'' (CDC, February 23,
2021), and ``CDC's Guidelines for Environmental Infection Control,''
pp. 86-103, 147-148, (CDC, July 23, 2019), both incorporated by
reference in 29 CFR 1910.509. Patient care areas do not include non-
healthcare settings that emergency responders or other licensed
healthcare providers enter to perform healthcare services. Emphasis for
cleaning and disinfection should be placed on surfaces that are most
likely to become contaminated with pathogens, including those in close
proximity to the patient and frequently-touched surfaces in the
patient-care environment (e.g., bed rails, bed frames, moveable lamps,
tray tables, bedside tables, handles, IV poles, and blood-pressure
cuffs).
Paragraph (j)(2)(i) requires employers to clean high-touch surfaces
and equipment (other than patient care areas, resident rooms, and
medical devices and equipment) at least once a day, following
manufacturers' instructions for application of cleaners. Areas covered
by paragraph (j)(2)(i) may include patient service counters,
waiting rooms, breakrooms, and offices not used for patient care.
Paragraph (b) defines high-touch surfaces and equipment to mean any
surface or piece of equipment that is repeatedly touched by more than
one person. Examples may include doorknobs, light switches,
countertops, handles, desks, tables, phones, keyboards, tools, toilets,
faucets, sinks, credit card terminals, and touchscreen-enabled devices
(e.g., tablets).
Employers must evaluate the workplace to determine which surfaces
and equipment need cleaning, and then ensure cleaning is performed at
least once each workday. While for most situations, daily cleaning will
be sufficient, as part of the hazard assessment required under
paragraph (c)(4)(i), employers may determine that some surfaces should
be cleaned more than once a day. Examples of items that an employer
might consider cleaning more than once per workday include any items
that are shared, such as tools, tablets, and remote controls. For
locations where visitors, patients, or guests frequently touch the same
surfaces and equipment as employees, such as at reception desks and in
waiting rooms, an employer might also consider cleaning these surfaces
and equipment more frequently.
Employers might also consider cleaning high-touch surfaces and
equipment at fixed locations (e.g., workstations, breakrooms) at each
shift change and when each employee rotates into the location. For
example, when employees work at fixed locations, such as transaction
counters (e.g., check-in counter, patient service counter), the
employer may consider cleaning between employees (i.e., whenever a new
employee rotates into the location). An employer may also consider
cleaning high-touch surfaces and equipment in common spaces, such as
bathrooms and breakrooms, at each shift change. Examples of high-touch
surfaces and equipment in these spaces may include faucets, sinks,
handles, and switches. For surfaces that are difficult to clean due to
many interstices, such as keyboards and elevator buttons, the employer
could apply plastic wrap to those surfaces for easier cleaning (Chen et
al., December 1, 2020).
Employers can satisfy their cleaning obligations through a variety
of means (e.g., contracting a cleaning service, shared responsibility
of employees). If the employer is relying on employees to clean, the
employer must provide cleaning supplies at no cost to the employee, and
should consider providing individual cleaning supplies to each employee
to prevent the need for employees to share those items. Employers must
also ensure employees have sufficient time during their work shift to
perform cleaning responsibilities, if applicable. To do this, an
employer could establish a schedule that specifies the time each day
when cleaning of high-touch surfaces and equipment will take place. In
determining how much time to allocate for cleaning, the employer must
ensure employees have enough time to follow the manufacturers'
instructions for cleaners.
When an employer is aware that a person who is COVID-19-positive
has been in the workplace within the last 24 hours, paragraph
(j)(2)(ii) requires employers to clean and disinfect any areas,
materials, and equipment under their control that have likely been
contaminated by the person who is COVID-19-positive (e.g., rooms they
occupied, items they touched). This requirement applies outside of
patient care areas, resident rooms, and medical devices and equipment
(for which employers must follow CDC guidance for cleaning and
disinfection in accordance with paragraph (j)(1)). In making
determinations under paragraph (j)(2)(ii) about which areas, materials,
and equipment have likely been contaminated, OSHA expects employers
will be informed by relevant CDC guidance, the specifics of any notice
received about a COVID-19-positive person in the workplace (see
paragraph (l)(3)(i)), such as when and where they were present, and
relevant information on the COVID-19 log (see paragraph (q)(2)(ii)).
Under this provision, cleaning and disinfection of areas and
equipment other than patient care areas, resident rooms, and medical
devices and equipment, must be done in accordance with ``CDC's Cleaning
and Disinfecting Guidance,'' which is incorporated by reference in 29
CFR 1910.509 (CDC, April 5, 2021). This includes closing off areas used
by the sick person and waiting at least several hours before cleaning
and disinfecting. While cleaning and disinfecting, this includes
opening outside doors and windows or using other methods to increase
air circulation when feasible, using products from EPA's List N, and
wearing a facemask and gloves. OSHA notes that if the employer learns
about a COVID-19-positive person more than 24 hours after the person
was in the area or used the materials or equipment, the employer does
not need to close off any areas or wait any longer before cleaning in
accordance with the rest of the CDC guidance. When the CDC guidance
recommends closing off spaces before cleaning and disinfecting,
employers do not necessarily need to close all operations if they can
close off just the affected areas. An employer should always focus on
cleaning and disinfecting frequently touched surfaces. However, if the
employer is aware that a person who is COVID-19-positive has occupied
the space, all potentially contaminated surfaces, regardless of touch
frequency, need to be cleaned and disinfected. Only after the space has
been cleaned and disinfected can it be reopened for use (CDC, April 5,
2021).
Paragraph (j)(3) requires employers to provide alcohol-based hand
rub that is at least 60% alcohol or provide readily accessible hand
washing facilities for use by employees. Practicing hand hygiene is an
effective way to prevent the spread of COVID-19. Hand hygiene is
defined in paragraph (b) to mean cleaning and/or disinfecting one's
hands using standard handwashing methods with soap and running water or
an alcohol-based hand rub that is at least 60% alcohol. In most
clinical healthcare settings, unless hands are visibly soiled, an
alcohol-based hand rub is preferred over soap and water due to evidence
of better compliance compared to soap and water. However, CDC
recommends healthcare workers wash their hands for at least 20 seconds
with soap and water when hands are visibly dirty, before eating, and
after using the restroom (CDC, May 17, 2020). To promote frequent and
thorough hand hygiene, paragraph (n)(1)(i) requires employers to train
employees on the importance of hand hygiene to reduce the risk of
spreading COVID-19 infections.
Employers must make available enough facilities (e.g., alcohol-
based hand rub dispensers or hand washing stations) and materials
(e.g., alcohol-based hand rub, soap, paper towels) so employees can
implement recommended hand hygiene practices. When determining the
appropriate number and placement of alcohol-based hand rub dispensers
or hand washing facilities, employers must consider the physical
distancing requirements in paragraph (h). Employers can consider
placing hand hygiene stations near building doors to promote hand
hygiene whenever employees enter the worksite and near vending machines
or where employees may eat (e.g., breakrooms, cafeterias) to ensure
hand hygiene prior to eating. When an employee's job tasks require PPE,
employers can also place hand hygiene stations near areas where PPE is
put on or removed. In addition, employees whose job tasks require them
to be away from hand washing facilities must be provided with
sufficient
alcohol-based hand rub to practice recommended hand hygiene. Signs that
encourage proper and frequent hand hygiene for employees can be placed
near hand hygiene stations to promote good hygiene. The CDC has created
hand hygiene materials that may be helpful for employers.
References
Centers for Disease Control and Prevention (CDC). (2019, July 23).
Guidelines for Environmental Infection Control in Health-Care
Facilities: Recommendations of CDC and the Healthcare Infection
Control Practices Advisory Committee (HICPAC). https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html. (CDC, July 23,
2019).
Centers for Disease Control and Prevention (CDC). (2020, May 17).
Hand Hygiene Recommendations: Guidance for Healthcare Providers
about Hand Hygiene and COVID-19. https://www.cdc.gov/coronavirus/
2019-ncov/hcp/hand-
hygiene.html#:~:text=Background,and%20infections%20in%20healthcare%20
settings. (CDC, May 17, 2020).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim Infection Prevention and Control Recommendations for
Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 5).
Cleaning and Disinfecting Your Facility: Every Day and When Someone
is Sick. https://www.cdc.gov/coronavirus/2019-ncov/community/disinfecting-building-facility.html. (CDC, April 5, 2021).
Chen, Y, Pradhan, S, Xue, S. (2020). Novel role of plastic wrap in
COVID-19. JAAD International, 1(2), 77-78. https://doi.org/10.1016/j.jdin.2020.06.001. (Chen et al., December 1, 2020).
Environmental Protection Agency (EPA). (2021, April 9). List N Tool:
COVID-19 Disinfectants. https://cfpub.epa.gov/giwiz/disinfectants/index.cfm. (EPA, April 9, 2021).
J. Ventilation
Improving ventilation is a critical component of an effective
multi-layered approach to controlling the spread of COVID-19 and is
required for compliance with the COVID-19 ETS. Accordingly, paragraph
(k) requires that employers who own or control buildings or structures
with an existing heating, ventilation, and air conditioning (HVAC)
system(s) ensure adequate ventilation in accordance with the specific
provisions of the paragraph.\137\ This requires employers to verify
that the system is functioning as designed.
---------------------------------------------------------------------------
\137\ There may be situations where workplaces have HVAC systems
but employers are not in control of the system, such as at
healthcare offices or clinics located within larger commercial
buildings. In these situations, employers should coordinate with the
building owner or operator to ensure that the requirements of
paragraph (k) are met. Additionally, the ETS does not require the
installation of new HVAC systems to replace or augment functioning
systems.
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All of the provisions in paragraph (k) align with guidance from
both the CDC and the American Society of Heating, Refrigerating and
Air-Conditioning Engineers (ASHRAE) (ASHRAE, 2020a; ASHRAE, 2020b; CDC,
March 23, 2021). The provisions in paragraph (k) aim to improve
ventilation by diluting and filtering the concentration of potentially
infectious particles in the air present in the workplace with fresh,
outside air to reduce exposure risk. Additional explanation of the
function and effectiveness of ventilation as a COVID-19 control is
provided in Need for Specific Provisions (Section V of this preamble).
As part of the ventilation provision, employers are required to
ensure the HVAC system(s) is used in accordance with the HVAC
manufacturer's instructions and the design-specifications of the HVAC
system(s), as outlined in paragraph (k)(1)(i). Because each building or
structure and its existing HVAC system(s) will be different, employers
and building owners/operators may find it necessary to consult with an
HVAC professional to ensure that HVAC systems are working as designed
to provide adequate ventilation according to these provisions. HVAC
professionals can determine the best way to maximize the system's
ventilation and air filtration capabilities for each specific room in
the building and thereby ensure the system is operating according to
the HVAC system(s) design specifications. Whenever implementing
ventilation improvements, employers and building owners should maintain
other indoor environmental quality parameters, such as moisture,
temperature, humidity, and air quality, which may be altered when
opening the building's outdoor air intake dampers. Additional guidance
on implementing these ventilation changes can be found in Technological
Feasibility (Section VI.A. of this preamble).
Paragraph (k)(1)(ii) requires that employers ensure the amount of
outside air supplied to the HVAC system(s) is maximized to the extent
appropriate and compatible with the HVAC system's capabilities.
Employers should work with building owners/operators to increase the
amount of outdoor air provided in the existing HVAC system(s), if
possible and if aligned with the capacity of the system. Maximizing the
amount of outdoor air being circulated through the HVAC system(s) to
the extent appropriate increases the amount of fresh air available
indoors, which decreases the concentration of potentially infectious
particles present in the air of that space. When maximizing outside air
circulation, employers and building owners should use caution in areas
where outdoor environmental contaminants (e.g., extreme heat or cold,
humidity, carbon monoxide, molds, pollen) may pose health risks.
Information on maximizing outdoor air is discussed in more detail in
Technological Feasibility (Section VI.A. of this preamble).
Under paragraph (k)(1)(ii), employers must also maximize, to the
extent appropriate, the number of air changes per hour (ACHs). ACHs are
a measure of the air volume that is added or removed from a space in
one hour per the volume of the space, or how frequently the air within
that space is replaced per hour. Maximizing ACHs will help dilute the
overall potential concentration of COVID-19 particles in the work
environment. ACHs are already commonly considered as a part of the
environment of care within healthcare facilities (CDC, 2003) and, as
such, employers in healthcare settings may already be in compliance
with this provision. As with other elements of this provision, a
ventilation expert or technician can assist a building owner/operator
or employer to maximize ACHs based on the workspace and the design
capabilities of the HVAC system(s). HVAC systems must always be
maintained and operated in accordance with design and manufacturers'
recommendations.
Air filters in HVAC systems remove particles, including aerosolized
particles that may contain COVID-19, from recirculated air streams
before returning the air to workspaces. Air filters are available in
many varieties and are made of different materials such as pleated
paper, cloth, woven fiberglass, and polyester. A filter's efficiency is
measured by the fraction of particles it is able to remove from the air
stream. Increased filter efficiency reduces the risk of COVID-19
transmission. There are several systems for rating filter efficiencies.
The most common is the Minimum Efficiency Reporting Value (MERV) rating
system developed by ASHRAE. Some air filters use alternative rating
systems and do not provide a MERV rating on their packaging. In such
cases, employers or building operators can determine the
filter's MERV rating by contacting the manufacturer or reviewing the
product description on their web page.
Paragraph (k)(1)(iii) requires air filters be rated as MERV-13 or
higher, if compatible with the ventilation system (ASHRAE, 2020a;
ASHRAE, 2020b). OSHA selected the MERV-13 filter as the minimum filter
requirement (assuming compatibility with the system) to follow the
recommendation of ASHRAE. Where a MERV-13 or higher filter is not
compatible with the HVAC system, employers must use the filter with the
highest compatible filtering efficiency for the HVAC system. The CDC
recommends upgrading filtration to the highest level possible without
significantly reducing design airflow (CDC, March 23, 2021). OSHA
agrees with the CDC recommendation that employers should use the
highest filtration system compatible with their HVAC system, but
because this is a mandatory standard OSHA has specified a minimum
filtration level, MERV-13, in order to provide clearer guidance to
employers (the CDC recommendation is non-mandatory guidance).
Filters with MERV ratings of 13 or greater are at least 85%
efficient at capturing particles similar in size to those carrying the
virus that causes COVID-19. Higher-rated filters, such as MERV-14 or
greater, capture particles more efficiently, but they also can slow
down the air flow. Increasing fan speed can help improve air flow to
counterbalance the impact of more efficient filters, but it is not
always possible to do so without stressing the HVAC system beyond its
capabilities, or without significant increases in energy use.
For that reason, HVAC systems are typically designed for specific
filter efficiencies and it is important to use a filter with a MERV
value as high as the system can handle (more efficient filtration), but
not higher. Some HVAC systems in healthcare facilities may be designed
and installed to operate with MERV-7 filters (e.g., in outpatient
spaces or resident care areas in assisted living facilities) (ASHE,
2014). Before upgrading to a higher-level filter, employers should
evaluate their existing HVAC system(s) to determine if it will be able
to operate properly with a MERV-13 or higher filter. In those
situations where MERV-13 or higher filters are not compatible with the
existing ventilation system, employers must use filters with the
highest compatible filtering efficiency for their HVAC system(s) to
maintain compliance with paragraph (k)(1)(iii). Employers should also
note that the requirement to upgrade filters applies to the ``final''
filter in cases where commercial or industrial HVAC systems have more
than one set of filters in series (e.g., the use of pre-filters to
extend the service life of final filters). Employers should consult an
HVAC technician or specialist before upgrading filter efficiencies in
HVAC systems if needed.
Dirty filters can decrease airflow and negatively affect HVAC
system performance. Paragraph (k)(1)(iv) requires employers to maintain
air filters and replace them as necessary to ensure the proper function
and performance of the HVAC system(s). Air filters must be maintained
and replaced in accordance with design and manufacturers'
recommendations. This would include, for example, the establishment of
a planned replacement schedule that identifies the frequency under
which filters should be replaced. Additionally, it is recommended that
a supply of replacement filters is kept on hand to ensure timely
replacement. When replacing filters, employers should follow
manufacturers' recommendations for appropriate PPE and provide PPE in
accordance with other OSHA standards.
Paragraph (k)(1)(v) requires that employers ensure all intake ports
that provide outside air to the HVAC system are cleaned, maintained,
and cleared of any debris that may affect the function and performance
of the HVAC system. This would include, for example, the establishment
and implementation of a planned maintenance schedule that identifies
the frequency with which the removal of dust and debris from ductwork,
vents, and intake ports must occur. These tasks should be completed as
frequently as necessary to ensure the function and performance of the
HVAC system are maintained, which can be determined with the assistance
of an HVAC technician or the building operator. Outdoor air intakes
must be inspected regularly to ensure they are not blocked or
obstructed, and dampers must be evaluated to ensure their proper
functionality, in accordance with ASHRAE recommendations (ASHRAE,
2020a). Employers may consider assessing indoor supply air diffusers
and return air grilles to ensure they are not blocked or obstructed,
are working properly, and their surfaces are clean.
Paragraph (k)(2) requires healthcare employers to maintain and
operate existing airborne infection isolation rooms (AIIR) in
accordance with their original design and construction criteria, where
AIIRs are used. AIIRs are required in healthcare settings when
performing aerosol-generating procedures on someone with suspected or
confirmed COVID-19, subject to feasibility. AIIRs lower the risk of
cross-contamination between patient rooms and reduce the risk of
transmission of COVID-19 between patients and employees (NIH, October
9, 2020). According to the CDC, AIIRs are rooms kept at negative
pressure relative to the surrounding areas with a minimum of 6 ACHs,
and 12 ACHs are recommended for newly constructed or recently renovated
spaces (CDC, February 23, 2021). The doors on AIIRs should be kept
closed except during entry or exit, and air from within AIIRs should be
exhausted directly to the outside of the building or should be filtered
through high-efficiency particulate air (HEPA) filters before it is
recirculated (CDC, February 23, 2021). Employers must ensure that the
proper negative-pressure function of AIIRs is maintained. Again,
employers and building owners/operators should consult with a
ventilation professional to ensure that AIIRs are operating as
designed. As described in note 1 to paragraph (k), this provision does
not require the installation of new AIIRs to replace or augment
functioning systems in healthcare facilities.
Employers should demonstrate a good-faith effort in achieving the
requirements outlined in paragraph (k) in the allotted time (i.e.,
within 30 days of the effective date of this standard, pursuant to
paragraph (s)(2)(ii)). This would include evaluating the existing HVAC
system, having conversations with building owners and operators,
attempting to schedule appointments with HVAC technicians, and
implementing changes to improve ventilation as much as feasible in
their workplace. Additional information on the timing of implementation
of ventilation requirements can be found in the summary and explanation
of Dates.
As note 2 to paragraph (k) states, employers should also consider
other measures to improve ventilation in accordance with guidance from
the CDC (CDC, March 23, 2021). While not required under this standard,
there are a variety of controls employers should consider to maximize
ventilation and filtration in buildings and structures without HVAC
systems or in addition to existing HVAC systems. OSHA is recommending
these, rather than requiring them, because there are too many variables
regarding when they are appropriate to make requirements simple and
clear in the regulatory text or to provide clear guidance as to when
employers would and would not be in compliance. Additional measures
could include increasing airflow to occupied
spaces, such as by opening windows and doors, if possible. Measures
that work to increase the amount of fresh air available could be used
during work hours, but also before and after occupancy to flush the
workspace.
Under note 2 of paragraph (k), employers should also consider ways
to maximize ventilation in vehicles when feasible. To do so, the driver
can open the windows, as weather permits. Similar to in buildings,
avoid opening windows and doors if doing so would pose health or safety
risks to employees or other occupants, such as exposure to outdoor
environmental contaminants (e.g., extreme heat or cold, humidity,
carbon monoxide, air pollution, molds, pollen). Additionally, the air
ventilation or air conditioning should be set to non-recirculation mode
to prevent the same, potentially contaminated, air from recirculating
throughout the vehicle (CDC, February 17, 2021).
Employers may consider using portable air cleaners fitted with
high-efficiency particulate air (HEPA) filters, especially in high-
occupancy areas or spaces with poor ventilation (ASHRAE, 2020a).
Portable air cleaners pull surrounding air in, filter it, and
recirculate cleaner air back into the room. If using portable air
cleaners, employers should consider the size of the room or space where
the unit will be used. Most manufacturers specify the size of the space
for which their units are designed. The Clean Air Delivery Rate (CADR)
is a measure of the effectiveness and capacity of the portable air
cleaner. The higher the CADR, the more particles the air cleaner can
filter and the larger the area it can serve. Units equipped with high-
efficiency particulate air (HEPA) filters typically achieve a higher
CADR and can remove at least 99.97% of dust, pollen, mold, viral
particles, and any airborne particles with a size of 0.3 microns
([micro]m) or greater, including particles containing the virus that
causes COVID-19. Portable air cleaners would be most effective if
placed as close to potential sources of COVID-19 as possible to
increase effective capture of the infectious particles. Additionally,
portable air cleaners should be placed to avoid blocking airflow, and
as such they should not be placed behind furniture or curtains. If
portable air cleaners are being used, employers should avoid creating
directional airflow across employees by drawing contaminated air past
breathing zones of employees. Avoid the use of fans around or above
portable air cleaners which can create currents that direct air away
from the filters and thereby reduce the efficiency of the air cleaner.
Finally, it is also recommended that all local exhaust fans (e.g.,
in restrooms) are functional and operating at full capacity when the
building or structure is occupied (ASHRAE, 2020a; ASHRAE, 2020b; CDC,
March 23, 2021).
References
American Society for Health Care Engineers (ASHE). (2014). Air
Filtration. https://www.ashe.org/compliance/ec_02_05_01/01/airfiltration. (ASHE, 2014).
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE). (2020a). Commercial. https://www.ashrae.org/technical-resources/commercial. (ASHRAE, 2020a).
American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE). (2020b). Filtration/Disinfection. https://www.ashrae.org/technical-resources/filtration-disinfection. (ASHRAE,
2020b).
Centers for Disease Control and Prevention (CDC). (2003). Background
C. Air: Guidelines for Environmental Infection Control in Health-
Care Facilities. https://www.cdc.gov/infectioncontrol/guidelines/environmental/background/air.html. (CDC, 2003).
Centers for Disease Control and Prevention (CDC). (2021, February
17). Protect Yourself when Using Transportation. https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/using-transportation.html. (CDC, February 17, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim Infection Prevention and Control Recommendations for
Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 23).
Ventilation in Buildings. https://www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html. (CDC, March 23, 2021).
National Institutes of Health (NIH). (2020, October 9). Infection
Control. https://www.covid19treatmentguidelines.nih.gov/critical-care/infection-control/. (NIH, October 9, 2020).
K. Health Screening and Medical Management
To reduce the risk of transmitting the virus that causes COVID-19
and possible infection to employees and others in the workplace, it is
essential to screen employees for illness, prevent infectious employees
from entering the workplace, and notify any employees who may have been
unexpectedly exposed to an individual with COVID-19 while not wearing a
respirator and other appropriate PPE. It is also critical to ensure
that employees are not disincentivized by fear of lost pay from
notifying their employer of COVID-19-related concerns that will require
their removal from the workplace. An employee with COVID-19 who does
not report their condition to their employer for fear of losing
essential income endangers everyone else at the workplace. The
provisions under paragraph (l) allow for early intervention to identify
and remove from the workplace employees who have or are likely to have
COVID-19, and to ensure that the employees receive sufficient
protections to encourage honest communication with their employers.
Screening employees for COVID-19 and removing them from the workplace
when they are infected or likely to be infected is critical for an
effective workplace infection prevention program and required for
compliance with these sections.
I. Screening
Paragraph (l)(1) discusses the requirements employers have for
screening employees. As defined in paragraph (b), screen means asking
questions to determine whether a person is COVID-19 positive or has
symptoms of COVID-19. As also defined in paragraph (b), COVID-19
symptoms may include fever or chills; cough; shortness of breath or
difficulty breathing; fatigue; muscle or body aches; headache; new loss
of taste or smell; sore throat; congestion or runny nose; nausea or
vomiting; or diarrhea. The CDC has recognized each of these symptoms as
potentially indicative of COVID-19 (CDC, February 22, 2021). As further
discussed in Grave Danger (Section IV.A. of this preamble), symptomatic
cases of COVID-19 can cause a range of illness, from mild cases to
severe or critical cases requiring hospitalization. Paragraph (l)(1)(i)
requires the employer to screen each employee before each workday and
each shift. Under this provision, screening may be conducted by asking
employees to self-monitor before reporting to work or may be done
through in-person methods conducted by the employer. To ensure this
screening requirement is properly implemented, employers are required
to educate and train all employees on the signs and symptoms of COVID-
19, and on the employer's policies and procedures for reporting
illness, as specified under paragraphs (n)(1)(i) and (n)(1)(viii).
Employers who choose to have employees self-monitor for COVID-19
symptoms can assist employees in that effort by providing them with a
short fact sheet to remind them of the symptoms of concern. Employers
may also consider posting a sign stating that any employee entering the
workplace
certifies that they do not have symptoms of COVID-19, to reinforce the
obligation to self-screen before entering the workplace.
Employers who choose to conduct in-person employee screening for
COVID-19 symptoms may ask the employee if they are experiencing
symptoms consistent with COVID-19. Employers should conduct this
screening before employees come into contact with others in the
workplace, such as co-workers, customers, patients, or visitors. When
implementing in-person screening, there are additional considerations
and responsibilities under this ETS as well as other potentially
applicable laws. Some individuals assisting with in-person screening at
the worksite may not be medical professionals, thus it is important
that the employer ensure that those individuals have any training that
is required as specified under paragraph (n)(1). This training must
include knowledge about the signs and symptoms of COVID-19, the
employer's policies and procedures for health screening, as well as job
tasks they would have to complete while conducting health screening.
When doing in-person screening, employers must protect employee
privacy and ensure that findings are kept confidential as required
under the Americans with Disabilities Act (EEOC, May 28, 2021) and in
accordance with other applicable laws. To maintain privacy, employers
should ask employees about symptoms in an area where others cannot hear
the responses (e.g., private room). To ensure screeners and employees
waiting to be screened are protected, an employer must continue to
maintain compliance with all requirements of this standard for physical
distancing, physical barriers, and facemask use; thus, employers may
need to provide physical barriers to separate employees and screeners
and ensure that employees waiting to be screened can maintain adequate
physical distancing between each other (see paragraphs (f), (h), and
(i)).
Employers have discretion in choosing whether to implement self-
monitoring or in-person screening; an employer can also choose to
utilize both methods. Both options have advantages and disadvantages
that may make them better suited for different types of work
environments. In-person screening allows the screener to remind the
employee about COVID-19 symptoms instead of relying on the employee to
recall the symptoms of concern. Additionally, in-person screening may
be easier for small healthcare employers (e.g., a small urgent care
clinic). For small healthcare facilities, it would likely be efficient
for the employer to ask employees if they are experiencing certain
symptoms in a private area. In-person screening may present more
challenges to larger healthcare facilities (e.g., a hospital), where
many employees may be arriving to work within the same timeframe. In
those cases, if employers choose to conduct in-person screenings, the
employer should ensure screenings are conducted in a timely manner to
minimize potential exposure both to other employees waiting to be
screened and to the screener.
Having employees self-monitor for COVID-19 symptoms before
reporting to work also has some advantages that employers may find
beneficial, such as protecting the employee's privacy, eliminating the
risk of potentially exposing others when commuting to the workplace
(e.g., passengers on public transportation), and avoiding close contact
between potentially infected employees and others when conducting in-
person screenings.
If the screening process reveals that an employee is experiencing
COVID-19 symptoms, the employer should determine whether the symptoms
require the employee's immediate removal from the workplace, discussed
in further detail below. The employer needs to be aware that screening
will not identify some employees who have COVID-19. Some individuals
with COVID-19 may be pre-symptomatic (i.e., have not developed symptoms
yet) or asymptomatic (i.e., do not develop symptoms over the course of
infection) but can still transmit the virus. Therefore, in settings
covered by the standard, employers must continue to follow all
requirements of the standard, using employee health screening as only
one component of a multi-layered approach.
Paragraph (l)(1)(ii) specifies that if the employer requires a
COVID-19 test for screening purposes, the employer must provide the
test to each employee at no cost to the employee. As defined in
paragraph (b), a COVID-19 test means a test for SARS-CoV-2 that is
both: (1) Cleared or approved by the U.S. Food and Drug Administration
(FDA) or is covered by an Emergency Use Authorization (EUA) from the
FDA to diagnose current infection with the SARS-CoV-2 virus; and (2)
administered in accordance with the FDA clearance or approval or the
FDA EUA, as applicable. Although it is not required under this ETS,
OSHA understands that some employers might choose to require employees
to be tested for COVID-19 before entering the workplace. Relatedly,
employers may require employees to undergo COVID-19 testing for other
work-related reasons, such as required screening before or after travel
to another state to perform work duties. If the employer chooses to
require testing, it must ensure it is using a COVID-19 test that
satisfies the definition in this standard, and the employer must pay
the employee for all costs associated with the test. This includes, for
example, costs of the test itself, as well as any time spent getting
the test or time spent waiting for test results before the employee is
allowed to enter the workplace. If getting the test requires the
employee to travel to a location that is not at the workplace, the
employer must pay the employee for the time spent traveling and for any
travel costs (e.g., transportation fare, gasoline). For more
information about the employer's obligation to implement the
requirements of this standard at no cost to employees, see the summary
and explanation discussion of No Cost to Employees below. Employers
should be aware that testing will not detect every employee who has
COVID-19. For example, false negative results could occur if the
employee is infected but is tested at a point in time where the levels
of virus being shed are below the detection limit of the test being
performed. For that reason, employers conducting testing must continue
to follow all requirements of this standard.
II. Employee Notification to Employer of COVID-19 Illness or Symptoms
Paragraph (l)(2) pertains to employee notification of COVID-19
illness or symptoms. Under this paragraph, the employer must require
each employee to promptly notify the employer of four different
circumstances. First, each employee must be required to promptly notify
their employer when the employee learns they are COVID-19 positive
(i.e., confirmed positive test for, or has been diagnosed by a licensed
healthcare provider with, COVID-19) (paragraph (l)(2)(i)). Thus,
employers must require employees to report their illness if they are
COVID-19 positive as confirmed by either a positive test or a licensed
healthcare provider's diagnosis. Second, employers must ensure that
each employee promptly notifies their employer if the employee has been
told by a licensed healthcare provider that they are suspected to have
COVID-19 (paragraph (l)(2)(ii)). Third, employers must ensure that each
employee promptly notifies their employer if the employee is
experiencing recent loss of taste and/or smell with no other
explanation (paragraph (l)(2)(iii)). If the employee
reports having a recent loss of taste and/or smell, the employer should
inquire as to whether there is any other explanation for the symptom
apart from COVID-19, but the employer is not required to ask nor is the
employee required to share any specific information about an
alternative condition that may explain the symptom. (Alternative causes
for recent loss of taste and/or smell could include, e.g., a non-COVID-
19 respiratory infection, sinus infection, or non-infectious
neurological disorder, such as Parkinson's disease.) Finally, under
paragraph (l)(2)(iv), employers must ensure each employee promptly
notifies their employer if the employee is experiencing both a fever
(>=100.4 [deg]F) and new unexplained cough associated with shortness of
breath. Again, if the employee reports having these symptoms, the
employer should inquire as to whether there is any other explanation
for the fever (e.g., an infection that is not related to COVID-19) or
cough associated with shortness of breath apart from COVID-19 (e.g., a
non-COVID-19 respiratory illness; a non-infectious condition such as
chronic obstructive pulmonary disease). And again, the employer is not
required to ask nor is the employee required to share any specific
information about the alternative explanation for the symptoms. To
distinguish from situations where shortness of breath is expected
(e.g., while conducting strenuous exercise or tasks), the employer
could frame the question in terms of whether the employee is
experiencing shortness of breath while at rest or in a way that makes
it more difficult to perform their job tasks or everyday activities.
The COVID-19 symptoms included in these latter two notification
categories should be included in the employer's required daily
screening so that employees are particularly cognizant of monitoring
for those symptoms in order to report them to their employer.
As noted, each of these notifications is required to be made to the
employer ``promptly.'' For employees who are not at the workplace when
they meet a notification criterion, ``promptly'' notifying the employer
would mean notifying the employer before the employee is scheduled to
start their shift or return to work. In the event that the employee is
in the workplace when meeting a notification criterion (e.g., the
employee starts experiencing a reportable symptom of COVID-19),
``promptly'' notifying the employer means notifying the employer as
soon as safely possible. For example, if a nurse caring for patients
starts to develop an unexplained loss of taste while at work, the nurse
should immediately notify their employer of their COVID-19 symptom
while avoiding exposing any other employees or non-employees. The
procedures for these notification requirements can be based on current
protocols that are in place for employees to notify the employer if
they are not able to come to work or need to leave work because of
illness or injury. The employer must train all employees on the
employer's policies and procedures for notifying the employer of
illness and symptoms, as specified under paragraph (n)(1)(viii). This
should include training employees on who to contact and how to contact
that person. For example, employees can be informed to contact
individuals such as their direct supervisor or the COVID-19 safety
coordinator(s) required by paragraph (c)(3). Employees must be given
this person's contact information, such as their email, workplace phone
number, or cellphone number, so that this information can be privately
and confidentially communicated to the employer. If an employer takes
all steps required under this paragraph but an employee fails to report
required information, the ETS does not dictate that any disciplinary
action be taken against the employee. If an employer is cited by OSHA
under this provision under such circumstances, the employer is entitled
to contest the citation if it can establish an employee misconduct
defense in accordance with applicable case law.
Each of these notification requirements are important measures to
ensure employers can take adequate steps to protect their employees
from the hazard of COVID-19 because each notification requirement is
connected to a parallel requirement in (l)(4) to remove the employee at
issue from the workplace. As described in Need for Specific Provisions
(Section V of the preamble), it is important to remove employees who
are confirmed or suspected to have COVID-19 from the workplace to
prevent the transmission of the virus that causes COVID-19 to other
employees. However, because COVID-19 symptoms are non-specific and
common with other infectious and non-infectious conditions, OSHA has
determined that it is not economically feasible to remove all employees
experiencing any potential symptom of COVID-19. Thus, OSHA has limited
required notification--and subsequent removal--to the symptoms
discussed above in paragraphs (l)(2)(iii)-(iv). As discussed in further
detail below, the decision to require notification of these particular
symptoms is based on a strategy that protects the safety of other
employees in the workplace by identifying criteria most likely to
capture COVID-19 employees within the constraints of feasibility. This
does not, however, prevent employers from using a broader range of
symptoms to exclude additional employees, as long as they ensure those
employees also do not suffer any adverse action as a result of that
removal as consistent with paragraph (l)(5)(v), discussed below.
OSHA considered several symptom lists to trigger notification and
removal of employees, each discussed in greater detail in Need for
Specific Provisions (Section V of this preamble). First, OSHA
considered basing notification and removal on the CDC list of symptoms.
However, that list is extremely broad and includes many common symptoms
that are not specific to COVID-19, such as fever or chills, cough,
fatigue, muscle or body aches, headache, congestion or runny nose,
nausea or vomiting, and diarrhea. Use of these symptoms could require
removal of large swaths of the workforce, many of whom may not have
COVID-19, and payment of accompanying medical removal protection
benefits. This would pose economic feasibility concerns (see Economic
Feasibility, Section VI.B), and it could leave employers, especially
small healthcare providers, without an adequate workforce to continue
operations in many cases. OSHA next considered basing notification and
removal on the Council of State and Territorial Epidemiologists (CSTE)
surveillance definition for COVID-19. However, while that list is
narrower than the CDC list, it still contains many common, non-specific
symptoms and thus presents the same concerns. For example, the CSTE
list would require removal of any employee experiencing just a cough,
which OSHA expects would result in removal of many employees who do not
have COVID-19. And although the CSTE definition also includes
consideration for more than one symptom (e.g., fever in addition to
sore throat), many of the symptoms that can be combined are also non-
specific and could potentially lead to removal of many employees who do
not have COVID-19.
Accordingly, OSHA found it necessary to develop its own list of
symptoms requiring notification and removal from the workplace, based
on the evidence discussed in Need for Specific Provisions (Section V of
the preamble), that adequately identifies infection hazards within the
realities of economic feasibility. As noted above,
these symptoms include: recent loss of taste and/or smell with no other
explanation; or fever (>=100.4 [deg]F) and new unexplained cough
associated with shortness of breath. OSHA has determined that recent
loss of taste and/or smell, without another explanation, is a symptom
that is highly specific for COVID-19 and the least likely symptom to
result in removing an employee from the workplace who does not have
COVID-19. The other symptoms--fever, cough, and shortness of breath--
are three of the symptoms that are most common to COVID-19, but fever
and cough are non-specific for COVID-19; accordingly, requiring removal
of any employee who has just fever or cough could result in the removal
of many employees who do not have COVID-19. However, a combination of
fever, cough, and shortness of breath is likely to result in higher
specificity that helps to avoid excluding employees who do not have
COVID-19. Therefore, requiring removal where an employee is
experiencing all three of these common COVID-19 symptoms will
ultimately lead to removal of employees who are likely to have COVID-
19, while not compromising an employer's ability to continue operations
by removing employees who do not have COVID-19. As discussed further in
Section VI.B, Economic Feasibility, OSHA has found removal in these
circumstances feasible.
OSHA's determination that employees must notify their employer, and
be removed from the workplace when they are experiencing the above
symptoms, is based on the best evidence currently available to the
agency. However, OSHA recognizes that it is operating at the frontiers
of science and it will, accordingly, continue to monitor the science,
and will make appropriate modifications to the ETS or adjustments in
enforcement policy as warranted by the evidence. Moreover, nothing in
this ETS precludes an employer from requiring employees to notify the
employer of additional symptoms of COVID-19 not specified by this
paragraph.
It is crucial that employees promptly inform their employer of
these circumstances because this information allows the employer to
take actions to protect other employees, including most critically by
removing employees who pose a direct threat of infection to other
employees in the workplace. The information conveyed by these
notifications also allows the employer to take other important steps to
protect its employees, including cleaning and disinfecting areas that
may have been contaminated (as required under paragraph (j)(2)(ii)). In
addition, the employer can start the required notifications to other
employees who may have been exposed to a COVID-19-positive employee, as
described in further detail below.
III. Employer Notification to Employees of COVID-19 Exposure in the
Workplace
Paragraph (l)(3) pertains to employer notification requirements to
employees regarding COVID-19 exposure in the workplace. An employer's
obligation under this section begins whenever the employer is notified
that a person who has been in its workplace is COVID-19-positive.
Subject to a limited exception with respect to certain COVID-19-
positive patients (discussed in further detail below), this
notification obligation is triggered by any COVID-19-positive person at
the workplace, including employees, clients, patients, residents,
vendors, contractors, customers, delivery people, visitors, or other
non-employees. Employers could be notified of an infected person in the
workplace by numerous sources including the affected individual
themselves, as well as the local or state health department, a family
member of a person confirmed to have COVID-19, or another employer
(e.g., an employer of a facility where a temporary employee was
working). The employer could also be notified by an employee who spoke
to any of the individuals listed above (e.g., an administrative
assistant), and forwarded the message to the employer. Once an employer
is notified of a COVID-19-positive person who has been in its
workplace, the employer has three separate notification obligations
that must be completed within 24 hours.
First, under paragraph (l)(3)(i)(A), the employer must notify each
employee who has been in close contact in the workplace with the person
who is COVID-19 positive while not wearing a respirator and any other
required PPE. ``Other required PPE'' in this provision (as well as in
paragraphs (l)(3)(i)(B) and (C)) refers to the other parts of the PPE
ensemble worn in addition to respirators when employees are exposed to
people with suspected or confirmed COVID-19, e.g., gloves, gowns, and
eye protection. Employees in healthcare settings are likely to be
exposed to ill persons as part of their job and have an understanding
of Standard and Transmission-Based Precautions. Therefore, they have an
understanding of pre- and asymptomatic transmission and how it affects
their risk of contracting COVID-19. Many times employees in healthcare
settings who are wearing respirators and other required PPE are doing
so because they are knowingly treating suspected or confirmed COVID-19
cases (as required by paragraph (f)(2)), so there is no need to inform
them of potential exposure. In some cases, employees in healthcare may
only be required to wear a facemask but are wearing both a respirator
and other PPE either voluntarily or at their employer's request.
Employees who choose to voluntarily upgrade their PPE presumably do so
based on an understanding that they could be exposed to someone who is
pre- or asymptomatic, even when all the other controls (e.g., patient
screening and placement) are properly implemented. An employer choosing
to upgrade PPE is exceeding the minimum requirements of the standard,
thus implying that such an employer is conscientious and would train
employees on the possibility of pre- and asymptomatic transmission.
Therefore, employees who are wearing PPE voluntarily or because their
employer chose to exceed the minimum requirements of the standard are
likely already aware of the potential for pre- and asymptomatic
exposure and the need to be especially vigilant in screening for COVID-
19 symptoms. OSHA does not find notification of close contacts or
exposures to individuals with COVID-19 necessary in these
circumstances.
The notification to these employees under paragraph (l)(3)(i)(A)
must state the fact that the employee was in close contact with someone
with COVID-19 along with the date(s) that the contact occurred. As
defined in paragraph (b), close contact means being within 6 feet of
any other person for a cumulative total of 15 minutes or more over a
24-hour period during that person's potential period of transmission.
The potential transmission period runs from 2 days before the person
felt sick (or, for asymptomatic people, 2 days prior to test specimen
collection) until the time the person is isolated. Examples of
cumulative exposures for 15 minutes could be 3 exposures for 5 minutes
each or 1 exposure for 5 minutes and a second exposure for 10 minutes,
over a 24-hour period. This definition in terms of proximity, duration,
and timing of exposure is consistent with CDC's current definition of
close contact, which is ``an operational definition'' used as the
criteria for conducting contact tracing (CDC, February 25, 2021). It is
based on the assumption that infection risk increases at decreased
distances and increased duration of exposure to an infected person
during the transmission period.
It is important to notify this category of employees because
individuals who have had close contact with a person who is COVID-19-
positive are at the highest risk of contracting COVID-19. Timely notice
of potential close contact with persons who are COVID-19-positive will
allow employees who have had close contact to seek medical advice and
be tested. Notifying those employees about the date that contact
occurred will allow them to verify that they were exposed. It also
allows them to provide that information to a licensed healthcare
provider or public health agency to determine factors such as optimal
time for testing. In addition, this gives employees necessary
information to be particularly vigilant in monitoring their own health
and symptoms, and to take steps to potentially avoid exposing others in
their household or community.
The second notification requirement, under paragraph (l)(3)(i)(B),
requires the employer to notify all other employees who worked in a
well-defined portion of a workplace (e.g., a particular floor) where
the person with confirmed COVID-19 was present during the potential
transmission period if the employees were not wearing a respirator and
any other required PPE. As stated above, the potential transmission
period runs from 2 days before the person felt sick (or, for
asymptomatic people, 2 days prior to test specimen collection) until
the time the person is isolated. This notification must specify the
date(s) the person with COVID-19 was in the workplace during the
potential transmission period. This notification is required if the
employer is aware that any person with confirmed COVID-19 (employee or
non-employee) was present in a facility for any length of time, even if
relatively brief.
OSHA has determined that it is important to notify this category of
employees even though they are generally at lower risk of developing
COVID-19 and do not meet the criteria for notification under CDC
contact tracing recommendations. Notifying these employees is important
because it can remind them to be aware of possible symptom development
in the less likely event that they do develop COVID-19. It will also
allow employees who may be at risk of developing COVID-19 in special
circumstances, despite the lack of close contact, to seek advice from
local or public health departments. CDC notes that infections can
sometimes occur from contact transmission. Thus, notifying a janitor
that an employee from a floor they service developed COVID-19 would
allow the janitor to seek information about possible risk from tasks
such as emptying trash contaminated with used tissues or paper towels.
As indicated above, notifying those employees about the date the person
with COVID-19 was in the workplace during the potential transmission
period will allow them to verify that they were exposed, as well as
provide the date(s) to a licensed healthcare provider or public health
agency to determine factors such as optimal time for testing.
Furthermore, determining which locations of a workplace a COVID-19-
positive person may have visited can also inform the employer about
ways to improve transmission prevention efforts, and improve the COVID-
19 plan under paragraph (c). For example, an employer may learn that a
delivery person confirmed to have COVID-19 visited many departments
throughout a hospital while making deliveries. Such information could
help the employer realize that numbers of persons exposed could be
minimized by leaving deliveries in the lobby and designating
individuals from certain areas of the building to pick up deliveries
while maintaining physical distance from others in the building.
Finally, under paragraph (l)(3)(i)(C), the employer must also
notify other employers whose employees have been in close contact with
the COVID-19-positive person in the workplace, or worked in a well-
defined portion of a workplace (e.g., a particular floor) in which the
COVID-19 positive person was present during the potential transmission
period if the employees were not wearing respirators and any other
required PPE. Again, the potential transmission period runs from 2 days
before the person felt sick (or, for asymptomatic people, 2 days prior
to test specimen collection) until the time the person is isolated. The
notification must specify the date(s) the person with COVID-19 was in
the workplace during the potential transmission period and the
location(s) where the person with COVID-19 was in the workplace. And
again, this notification is required if an employer is aware that any
person with confirmed COVID-19 (employee or non-employee) was present
in a facility for any length of time, even if relatively brief.
The purpose of notifying other employers whose employees had close
contact with or were in the same well-defined portion of a workplace as
the COVID-19 positive person during the potential transmission period
is to ensure that employees who are not directly employed by the
business or facility (e.g., host employer) where they were potentially
exposed will also be notified of exposures. Examples of employers who
would need to be notified include contracting agencies, temporary
staffing agencies, vendors, and delivery services. Providing them with
the information required under paragraph (l)(3)(i)(C) will allow the
employers and employees to determine if they could have been exposed,
and will allow the employee to contact a licensed healthcare provider
or local or state public health official for information to help them
determine factors such as optimal time for testing. Because the host
employer is the one who controls the workplace, OSHA expects that the
host employer would have the details to determine which employees at
the workplace could have had close contact with, and which could have
been in the same well-defined area as, someone who is COVID-19
positive. This would allow the host employer to inform other employers
(e.g., contractors, temporary staffing agencies, vendors, delivery
services) if one of their employees had close contact with or could
have been in the same well-defined area as a COVID-19-positive person
during their transmission period. This would then allow employers such
as contractors, temporary staffing agencies, vendors, and delivery
services to notify their employees, as required under paragraphs
(l)(3)(i)(A) and (B).
Each of the three notification requirements in paragraphs
(l)(3)(i)(A)-(C) is subject to one exception, found in paragraph
(l)(3)(iii). That exception provides that the notification provisions
are not triggered by the presence of a patient with confirmed COVID-19
in a workplace where services are normally provided to suspected or
confirmed COVID-19 patients (e.g., emergency rooms, urgent care
facilities, COVID-19 testing sites, COVID-19 wards in hospitals). This
exception recognizes that the notifications required by paragraph
(l)(3)(i)(A)-(C) are not necessary in workplace settings where
employees already expect to be working near suspected or confirmed
COVID-19 patients and are, therefore, already aware of their potential
for exposure. However, this exception is limited to scenarios where
services are normally provided to patients who are suspected or
confirmed to have COVID-19. For example, this exception would not apply
to a mammography center at a hospital not otherwise excepted from the
ETS that conducts screening to identify patients who have COVID-19 and
excludes them from receiving services at the center. If that center
learns that a person who is COVID-19 positive visited the center during
the
period of transmission, the employer would be required to notify all
employees who were not wearing a respirator and other PPE and either
had close contact with the person or were in the same well-defined
portion of the workplace as the person. In another example, a hospital
has a designated wing for COVID-19 patients, but a COVID-19 patient is
mistakenly taken to a non-COVID-19 wing for treatment first. The
employer would be required to notify all employees who were not wearing
a respirator and other PPE and either had close contact or were in the
same well-defined portion of the workplace as the COVID-19 patient,
outside of the COVID-19 wing.
Each of these three notification requirements is critical to
ensuring that individuals who are at potential risk of developing
COVID-19 are promptly made aware of that risk so that they can take
appropriate steps to monitor their health. As previously noted, the
employer is required to make all of these notifications within 24 hours
of learning that a COVID-19-positive person was in the workplace. OSHA
has determined that this time period is necessary to ensure that
employees receive timely information about a potential risk to their
own health and to the health of those around them, as the notified
employees may now be infectious themselves as a result of their
exposure to a COVID-19-positive person. Prompt notification would allow
the employee to start taking precautions such as physically distancing
from household members to prevent transmission in the event that the
employee is or becomes infectious. When making required notifications,
employers should notify each individual in a language and manner they
understand via a phone call, text message, email, or in person (if
using protections such as physical distancing and face coverings).
However, in some cases, such as when close contact did not occur and
all persons who could have been potentially exposed in a general area
may not be known (e.g., bathroom, building floor), the employer could
satisfy notification requirements by posting notices in languages that
employees understand in common areas. This may include posting notices
in break rooms, time clock areas, or restrooms, as well as using
alternative modes of communication needed to reach employees with
disabilities.
In certain circumstances it may be difficult for employers to
determine every person who is required to be notified of a COVID-19
exposure or close contact in the workplace. Employers should try and
get as many details as possible about areas of the workplace visited
and other areas where employees could have been exposed. Employers will
often learn about a COVID-19-positive person in their workplace through
the local public health authorities (CDC, October 22, 2020), and they
should cooperate with those authorities in identifying potentially
exposed employees. Employers should use reasoned judgment based on the
information that is available to them in making the determination of
who is required to be notified under this standard. Notification
obligations exist under the standard where it is more likely than not
that a COVID-19 person was either in close contact with an employee, or
in the same well-defined area as an employee. However, OSHA recommends
that employers should err on the side of over-inclusion where not
otherwise clear and make notifications whenever it is likely that a
close contact or exposure has occurred.
Paragraph (l)(3)(ii) provides that notifications required by
paragraph (l)(3)(i) must not include any employee's name, contact
information (e.g., phone number, email address), or occupation and the
employer should avoid sharing any unnecessary information that might
reveal the employee's identity. This provision is necessary to ensure
compliance with the ADA and other applicable laws. To notify employees
while still protecting the infected employee's identity, employers
could use vague descriptions such as ``a person confirmed to have
COVID-19 was recently in the workplace and you may have been exposed.''
However, OSHA is aware that even if no personally identifiable
information is provided, other employees may be able to figure out the
identity of the person with COVID-19. For example, at a small urgent
care clinic, it may be obvious that a certain employee has not been
reporting to work. As long as the employer does not reveal any of the
personally identifiable information described above and has made a
good-faith effort to comply with this provision, the employer will be
considered to have complied with this provision even if it is possible
for others to figure out the identity of the affected employee.
However, the employer should review other guidance on privacy and
confidentiality of medical information from other relevant agencies
(see, e.g., EEOC, May 28, 2021). Paragraph (l)(3)(ii) is not intended
to preclude the sharing of information that is permitted between
medical providers under the Health Insurance Portability and
Accountability Act (HIPAA).
IV. Medical Removal From the Workplace
Paragraph (l)(4) contains requirements regarding medical removal of
employees from the workplace. There are three triggers for employer
obligations under this paragraph. The first is if an employer knows
that an employee is COVID-19 positive (i.e., the employee meets the
criteria in paragraph (l)(2)(i)). The second is if an employer knows
that an employee meets the criteria in paragraph (l)(2)(ii) through
(l)(2)(iv)--that is, the employee has been told by a licensed
healthcare provider that they are suspected to have COVID-19; they are
experiencing recent loss of taste and/or smell with no other
explanation; or they are experiencing both fever (>=100.4 [deg]F) and
new unexplained cough associated with shortness of breath. The third is
if an employer is required to notify an employee of close contact in
the workplace to a person who is COVID-19 positive in accordance with
paragraph (l)(3)(i)(A). These triggers result in different exclusion
requirements.
Under the first trigger, where an employer knows an employee is
COVID-19-positive, paragraph (l)(4)(i) requires the employer to
immediately remove the employee from the workplace and keep the
employee removed until the employee meets the return to work criteria
in paragraph (l)(6), as discussed below. OSHA determined that directing
an employee who is COVID-19 positive to stay home until return to work
criteria are achieved is critical to preventing the transmission of
COVID-19 in the workplace.
Following the second trigger, when an employer knows that an
employee meets the criteria in paragraph (l)(2)(ii) through (l)(2)(iv),
paragraph (l)(4)(ii) requires the employer to immediately remove the
employee from the workplace. The employer then may choose between two
options. The first option, described in paragraph (l)(4)(ii)(A), is to
keep the employee removed until the employee meets return-to-work
criteria. The second option, described in paragraph (l)(4)(ii)(B), is
to provide a COVID-19 polymerase chain reaction (PCR) test at no cost
to the employee and keep the employee removed until the employer is
notified by the employee of the test results. If the test results are
negative, the employee may return to work immediately. If the test
results are positive, the employer must comply with paragraph (l)(4)(i)
and keep the
employee removed until the employee meets return-to-work criteria. If
the employee refuses to take the test, the employer must continue to
keep the employee removed from the workplace until return-to-work
criteria are met, but is not obligated to provide the medical removal
protection benefits described in paragraph (l)(5)(iii). Additionally,
absent undue hardship, employers must make reasonable accommodations
for employees who cannot take the test for religious or disability-
related medical reasons, consistent with applicable non-discrimination
laws. For example, in such circumstances OSHA would expect the employer
to consider accommodations such as providing a different kind of test
or medical evaluation that does not raise the same religious or medical
concerns; making arrangements for the employee to work in isolation or
remotely; or proceeding as if the test results were positive, and
keeping the employee removed until return-to-work criteria are met,
while providing medical removal protection benefits.
As the standard does not indicate how the employee must notify the
employer about the results of the test, the employer has flexibility to
decide on the method of notification. For example, the results could be
provided to the employer as a verbal report from the employee of the
results, as a written note from the appropriate medical professional
disclosing only the results, or via other methods that conform to
applicable confidentiality and privacy laws.
Following the third trigger, when an employer is required to notify
an employee of close contact in the workplace with a person who is
COVID-19 positive, paragraph (l)(4)(iii)(A) requires the employer to
immediately remove the employee from the workplace. The employer then
has a choice between two different actions. The first option is that
the employer may keep the employee removed from the workplace for 14
days. The second option is to keep the employee removed and provide a
COVID-19 test, at no cost to the employee, at least 5 days after the
exposure that triggered the notification requirement. If the test
results are negative, the employee may return to work after 7 days have
passed following the exposure. If the test results are positive, the
employer must comply with paragraph (l)(4)(i) and keep the employee
removed until the employee meets return to work criteria specified in
paragraph (l)(6). If the employee refuses to take the test, the
employer must continue to keep the employee removed from the workplace
for 14 days, but is not obligated to provide the medical removal
protection benefits described in paragraph (l)(5)(iii). Absent undue
hardship, employers must make reasonable accommodations for employees
who cannot take the test for religious or disability-related medical
reasons, as described above.
Paragraph (l)(4)(iii)(B) contains an exception to the removal
requirements following the third trigger. An employee who would
otherwise be required to be removed after exposure in the workplace
does not need to be removed if the employee does not have a recent loss
of taste and/or smell or fever combined with cough and shortness of
breath, and the employee has been fully vaccinated against COVID-19
(meaning two or more weeks have passed after receiving the final dose)
or the employee has had COVID-19 and recovered from it within the past
3 months. OSHA included this exception for fully vaccinated employees
because it is consistent with CDC recommendations, as described in more
detail in Need for Specific Provisions (Section V of the preamble). The
exemption for asymptomatic employees who were confirmed to have COVID-
19 and recovered within the last three months from removal is also
consistent with CDC recommendations. As explained in more detail in
Section V, the CDC has analyzed accumulating evidence indicating that
persons who have recovered from laboratory-confirmed COVID-19 and
remain symptom-free may not have to quarantine again if exposed within
three months of the illness. Although the evidence does not
definitively demonstrate the absence of reinfection within a three-
month period, CDC concluded that the benefits of avoiding unnecessary
quarantine likely outweigh the risks of reinfection as long as other
precautions such as physical distancing, face coverings, and hygiene
continue to be implemented. OSHA will continue to follow this issue
closely and will make adjustments to the ETS or modify enforcement
activities as appropriate when additional information becomes available
and/or if the CDC recommendations are updated.
OSHA identified the triggers for medical removal to create a policy
that ensures the safety of other employees in the workplace, consistent
with economic feasibility constraints and the employer's need to
maintain a sufficient workforce to continue operations. OSHA determined
that requiring the removal of employees who are COVID-19 positive or
who are suspected to be COVID-19 positive based on medical advice is
essential to prevent the transmission of the virus that causes COVID-19
through the workplace. Employees who are confirmed COVID-19 positive
pose a clear and direct hazard to their co-workers, and those who are
suspected to be COVID-19 positive also present a significant hazard to
their co-workers because of the likelihood that they do, in fact, have
COVID-19.
Removal of employees based on symptoms is less straightforward
because many symptoms of COVID-19 are common with other diseases or
health conditions. As explained above in the section on notification
requirements, OSHA determined it would not be feasible or reasonable to
require the removal of any employee who merely experiences any symptom
of COVID-19, because many COVID-19 symptoms are also symptoms of less
dangerous illnesses such as the common cold or conditions that are not
infectious, such as allergies. Therefore, removing any employee
experiencing these symptoms alone would likely mean the removal of many
employees who do not have COVID-19, which could be unduly burdensome to
the employer. As discussed in Need for Specific Provisions (Section V
of the preamble), OSHA identified the symptoms of recent loss of taste
and/or smell and fever coupled with new unexplained cough and shortness
of breath as removal triggers because this symptom or symptom
combination is highly specific for COVID-19, and under the scenarios of
the studies described in Section V, would likely result in the removal
of relatively few employees who do not have COVID-19.
OSHA encourages employers who are able to do so to have a more
robust program of medical removal. To this end, a note to paragraph
(l)(4)(ii) explains that the symptoms OSHA has selected as requiring
removal constitute only a partial list of the symptoms that CDC has
recognized as being COVID-19 symptoms. Employers may choose to go
beyond the minimum requirements laid out in the ETS and remove
employees who display additional symptoms from the CDC list (such as
chills, fatigue, or congestion; fever in the absence of cough; or cough
in the absence of fever) or refer those employees to a healthcare
provider.
OSHA has also determined that individuals who have had close
contact with someone in their workplace who is COVID-19-positive are at
risk of contracting COVID-19. As has been established in Grave Danger
(Section IV.A. of this preamble), COVID-19 readily transmits in
healthcare workplaces where employees come into
contact with patients who are suspected or confirmed to have COVID-19,
often for extended periods of time and often in areas that are poorly
ventilated. Thus, if an employee has had a close contact in a
healthcare workplace, the likelihood that they may be COVID-19 positive
is sufficiently high that the employee should be removed from the
workplace, pending the results of a COVID-19 test, in order to mitigate
any risk of transmission to other employees. OSHA determined that
requiring removal of these employees, at least until the employee has
received a negative COVID-19 test, strikes the appropriate balance
between reducing the risk to others in the workplace and maintaining
adequate staffing. As discussed above, employees who have been fully
vaccinated or who have recently recovered from COVID-19 need not be
removed at all, as long as they are not experiencing a recent loss of
taste and/or smell or fever combined with cough and shortness of breath
because of the lower likelihood that they would have COVID-19 at this
time. The timeframes for testing and return to work of employees in the
third category are drawn from CDC guidance, and the scientific
rationale supporting those timeframes is discussed in Need for Specific
Provisions (Section V of the preamble).
Finally, paragraph (l)(4)(iv) provides that whenever an employee is
removed from the workplace as outlined above, the employer may require
the employee to work remotely or in isolation, if suitable work is
available. For example, a physician who ordinarily performs telehealth
visits from a hospital office could be required to work from home as
long as the appropriate technology is available. Alternately, the
physician could work alone in a separate office away from the hospital
(i.e., in isolation) to avoid contact with other people. This provision
helps ensure continuity of healthcare services by allowing a job
function to be performed when the employee is able to work from home or
in an isolated setting. In cases where working remotely is not
possible, OSHA encourages employers to consider flexible and creative
solutions. For example, a temporary reassignment to a position that can
be performed by telework might be a possibility. However, if an
employee is too ill to work, remote work should not be required; and
sick leave or other leave should be made available as consistent with
the employer's general policies and any applicable laws.
OSHA's removal requirements as outlined in this paragraph are
intended to set the floor for what is required; however, as stated
above OSHA encourages employers who are able to do so to have a more
robust program of medical removal, as indeed some employers have
already done. In addition to removal based on other COVID-19 symptoms,
employers may consider removal based on certain exposure or close
contacts employees have had outside of the workplace. Similarly,
employers may consider removal of employees if the employer learns that
the employee was notified by a state or local public health authority
to quarantine or isolate; the employer might even be contacted by such
an authority directly. Although the ETS does not require removal in
those situations, the state or local public health authority may impose
separate obligations or the employer might choose to remove employees
in those circumstances, above and beyond what is required by this ETS.
V. Medical Removal Protection Benefits
Paragraph (l)(5) requires, with some limitations, that employers
continue to pay employees who have been removed from the workplace
under the medical removal provisions found in paragraph (l)(4). OSHA
determined that requiring continued pay for removed employees under the
listed circumstances is necessary to ensure that employees do not
refrain from reporting their COVID-19-positive status or symptoms out
of the fear of losing essential income. It is also necessary to ensure
that during contact tracing, COVID-19-positive employees do not refrain
from reporting close contacts with their co-workers out of fear that
those co-workers will suffer a loss of pay.
The requirement to maintain pay for removed workers applies to
employers that have more than 10 employees on the date the section
becomes effective. OSHA created this exception for very small
employers--those with 10 or fewer employees--to ensure consistency with
the exceptions in other parts of the ETS. As noted earlier, the ETS
does not require these small employers to maintain written COVID-19
plans (paragraph (c)(2)), and exempts them from certain recordkeeping
requirements (paragraph (q)(1)). OSHA acknowledges the concern that
removal may leave smaller employers without an adequate workforce to
continue operations in some cases. For instance, even a small outbreak
at a healthcare facility with fewer than 10 employees could cause the
facility to lose a large percentage of its current staff (e.g., one
confirmed positive case and 2 additional employees removed due to close
contact) with their specific knowledge of the facility's operations.
OSHA also created the exception to the requirement to provide benefits
to employees who are removed from the workplace because, compared to
larger employers, employers with 10 or fewer employees are more likely
to have to close temporarily if enough staff are removed and could be
particularly susceptible to challenges of providing benefits payments
while the business is temporarily closed, as well as weathering any
significant duration of time between the outlay of pay to removed
employees and the receipt of tax offsets. OSHA is therefore requiring
medical removal protection benefits to be paid only by employers that
have more than 10 employees.
When an employee is working remotely or in isolation in accordance
with paragraph (l)(4)(iv), the employer must continue to pay that
employee the same regular pay and benefits the employee would have
received had the employee not been absent from work, until the employee
meets the return-to-work criteria discussed below. If the employee is
able to work remotely or in isolation, then the employee is entitled to
payment for all time worked, including overtime, when applicable. When
an employee has been removed from the workplace under paragraph (l)(4)
(i.e., and is not working remotely or in isolation), the employer must
also continue to pay the employee the same regular pay and benefits the
employee would have received had the employee not been absent from
work, but that regular pay does not include overtime pay even if the
employee had regularly worked overtime hours in recent weeks. If an
employee is removed from work multiple times as required by the ETS,
such as because of being exposed at different times at the workplace to
people with COVID-19, the employer must pay the employee during removal
on each occasion.
When an employee has been removed and is not able to work remotely
or in isolation, however, the amount the employer is required to pay is
capped at a maximum per week. The employer must continue to provide the
benefits to which the employee is normally entitled and must also pay
the employee the same regular pay the employee would have received had
the employee not been absent from work, up to $1,400 per week, until
the employee meets the return to work criteria specified in paragraph
(l)(4)(iii) or (l)(6). For employers with fewer than 500 employees, the
same requirements for benefits and pay apply as for larger employers,
except that beginning in the third week of the employee's removal,
the required payment is reduced to only two-thirds of the same regular
pay, up to $200 per day ($1,000 per week in most cases). The cap
amounts are specified in paragraphs (l)(5)(iii)(A) and (B).
For all employers, the cap is $1,400 per week per employee for the
first two weeks of removal. OSHA considered an analysis by the Council
of Economic Advisers (CEA) in determining the level at which to set the
cap. This analysis found workers well into the middle class were
``liquidity constrained,'' and therefore would be responsive to the
incentives of medical removal pay (CEA, February 18, 2021). Based on an
analysis of the expected cost of MRP versus income distribution, CEA
found that a minimum threshold of $1,300 per week would be appropriate.
It also noted a number of factors that would support increasing the
threshold, including the advent of rapid testing and the spread of
vaccination, both of which lower the cost of MRP. While the CEA
analysis is based on a review of general economic data not specifically
targeted to healthcare industries, there is no evidence to suggest that
healthcare is meaningfully different from other industries with regard
to incentivizing employee reporting. OSHA finds that the increased
amount of $1,400 per week is appropriate because it ensures adequate
incentive effects of replacement pay for a large majority of the
affected workforce.
For employers with fewer than 500 employees, the cap is $1,400 per
week for the first two weeks an employee is removed from work, but is
reduced to only two-thirds of regular pay, up to $200 a day (equivalent
to $1,000 per week over a 40-hour, 5-day work week) beginning in the
third week, if the employee's removal continues that long. This lower
cap amount beginning in the third week is consistent with the maximum
amount of tax credits that employers with fewer than 500 employees may
claim after the first 80 hours of leave under the ARP (IRS, April
2021). Larger employers with 500 or more employees must continue to pay
up to $1,400 per week even after the initial two weeks an employee is
removed from work. (The cap does not preclude employers from paying
more than either of these amounts, however.) OSHA expects most
employees should be able to return to work within 10 days of developing
symptoms or 14 days (2 work weeks) from removal, and only a relatively
small number will need to remain out for a longer period of time
because of COVID-19 symptoms.
Paragraph (l)(5)(iv) provides that if an employee who has been
removed from the workplace and is not working remotely or in isolation
receives compensation for lost earnings from any other source, such as
employer-paid sick leave, administrative leave, or a publicly-funded
compensation program, then the employer may reduce the amount paid to
the removed employee by however much the employee receives from the
outside source. For example, if a removed employee who is not working
remotely or in isolation has accumulated paid sick leave, the employer
may require the employee to use that paid sick leave before paying
medical removal benefits under this paragraph. If an employee has paid
leave available, but the employer is unable to require the employee to
use the leave (as may be the case with federal employers) and the
employee opts not to use it, then the employer may still reduce the
amount paid under this paragraph by the amount of paid leave the
employee has available but is opting not to use. Likewise, if a removed
employee receives, for example, $300 a week from a state or local
government benefits program for quarantined or isolated employees, the
employer's obligation to pay medical removal benefits to the removed
employee would be reduced by $300 per week.
OSHA recognizes that certain employees who are COVID-19 positive
may be required to be removed from the workplace for some time. For
example, as explained in Need for Specific Provisions (Section V of the
preamble), some people such as those with severe illness or immune
disorders might be infectious and need to be removed for 20 days or
more. However, most employees required to be removed will be out of the
workplace for a relatively short period of time, and can return to work
after as little as ten days from their positive test or from when
symptoms first appeared, as described further in the discussion of
paragraph (l)(6), below. Employees removed under paragraph
(l)(4)(iii)(A) after close contact with a COVID-19 positive person in
the workplace can return to work as soon as seven days after the close
contact if their employer-provided COVID-19 test is negative.
Additionally, an employer's obligation to provide paid medical removal
benefits ends when an employee meets the return-to-work criteria (i.e.,
is no longer likely infectious), even if the employee is experiencing
persistent debilitating effects of the disease and is unable to work
for that reason. If a state or local health department requires an
employee to continue isolating after the return to work criteria in
this ETS are met, those entities may impose separate requirements, but
the ETS would not require the employer to continue providing paid
medical removal benefits.
Under paragraph (l)(5)(v), when employees return to work after
their removal period, they must not be subject to any adverse action or
deprivation of rights or benefits because of their removal. This means
that an employer cannot take actions such as terminating the employment
of a removed employee or demoting the employee to a lower-paying
position, regardless of the length of time spent away from the
workplace. Protecting employees' job status and prohibiting adverse
actions by the employer as a result of a COVID-19-related exclusion is
crucial for ensuring that employees report COVID-19 positive status or
symptoms to the employer. If employees fear job loss or other adverse
actions as a result of removal for a COVID-19-related reason, they will
likely be reluctant to make these reports. OSHA realizes there may be
situations where an employee with COVID-19 is out of work for months
before they are well enough to return to work, and the employer may
need to fill the employee's position during the removal period. In this
situation, OSHA would expect that the employer would fill the position
with a temporary employee, who is made aware that the temporary
assignment will end once the removed employee returns to work. The
removed employee's position should not be permanently filled by a
replacement unless the employee notifies the employer, or the employer
is able to verify, that the employee will not be returning to their
former position. The provision is consistent with Section 11(c) of the
OSH Act, 29 U.S.C. 660(c)(1), which prohibits discrimination or
discharge of any employee for exercising any right afforded under the
Act.
VI. Return to Work
Paragraph (l)(6) contains requirements related to an employee's
return to work after a COVID-19-related workplace removal. It provides
that an employer's decision to return an employee to work must be made
in accordance with guidance from a licensed healthcare provider or
applicable guidance from the CDC which are incorporated by reference
(CDC, February 16, 2021; CDC, February 18, 2021a; CDC, February 18,
2021b), unless state or local public health authorities specify a
longer period of removal. The purpose of this provision is to ensure
that an employee who has or likely has COVID-19 does
not return to work until it is highly likely that there is no longer a
significant risk of transmitting disease.
CDC's recommendations for isolation are only broad guidance; the
appropriate duration for any given individual may differ depending on
factors such as disease severity or the health of the employee's immune
system. For this reason, the ETS requires that employers make decisions
about an employee's return to work in accordance with guidance from a
licensed healthcare provider (who would be better acquainted with a
particular employee's condition) or CDC guidance. For example, the
``CDC's Isolation Guidance,'' referenced in paragraph (l)(6) states
that a COVID-19 positive person can stop isolating when three criteria
are met: (1) At least ten days have passed since the first appearance
of the person's symptoms; (2) the person has gone at least 24 hours
without a fever (without the use of fever-reducing medication); and (3)
the person's other symptoms of COVID-19 are improving (excluding loss
of taste and smell). If a person has tested positive but never
experiences symptoms, then the person can stop isolating after ten days
from the date of their positive test. If a licensed healthcare provider
recommends a longer period of isolation for a particular employee,
however, then the employer would need to abide by those longer periods
rather than returning the employee to work after ten days. Employers
are also free to require employees to remain removed for a longer
period than the ETS requires. For example, an employer that serves a
vulnerable population of clients may want to use extra caution and
require employees to stay isolated past the time when a licensed
healthcare provider says the employee may return to work. The
employer's obligation to pay medical removal benefits under paragraph
(l)(5)(iii) ceases when the employee meets the return-to-work criteria
listed in paragraph (l)(6), even if the employer chooses to require a
longer removal period.
Finally, in a note to paragraph (l), OSHA recognizes that CDC's
``Strategies to Mitigate Healthcare Personnel Staffing Shortages''
allows elimination of quarantine for certain healthcare workers, but
only as a last resort, if the workers' absence would mean there are no
longer enough staff to provide safe patient care, other specific
amelioration strategies have already been tried, patients have been
notified, and workers are utilizing additional PPE at all times (CDC,
March 10, 2021). OSHA recognizes that in these limited circumstances,
there are different feasibility constraints, as contemplated by the
CDC, that may be appropriate, and OSHA will enforce the requirements of
paragraph (l) in accordance with these considerations.
References
Centers for Disease Control and Prevention (CDC). (2020, October
22). Case Investigation and Contact Tracing in Non-healthcare
Workplaces: Information for Employers. https://www.cdc.gov/coronavirus/2019-ncov/community/contact-tracing-nonhealthcare-workplaces.html. (CDC, October 22, 2020).
Centers for Disease Control and Prevention (CDC). (2021, February
16). Criteria for Return to Work for Healthcare Personnel with SARS-
CoV-2 Infection (Interim Guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/return-to-work.html. (CDC, February 16, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, February
18). Discontinuation of isolation for persons with COVID-19 not in
healthcare settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html. (CDC, February 18, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, February
18). Isolate if you are sick. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/isolation.html. (CDC, February 18, 2021b).
Centers for Disease Control and Prevention (CDC). (2021, February
22). Symptoms of coronavirus. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. (CDC, February 22, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
25). Contact tracing for COVID-19. https://www.cdc.gov/coronavirus/
2019-ncov/php/contact-tracing/contact-tracing-plan/contact-
tracing.html#:~:text=Summary%20of%20COVID%2D19%20Specific%20Practices
&text=Contact%20tracing%20will%20be%20conducted,or%20probable%20COVID
%2D19%20patients. (CDC, February 25, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 10).
Strategies to mitigate healthcare personnel staffing shortages.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/mitigating-staff-shortages.html. (CDC, March 10, 2021).
Council of Economic Advisers (CEA). (2021, February 18). Staff Memo.
Continuing OSHA emergency temporary standards (ETSs). (CEA, February
18, 2021).
Equal Employment Opportunity Commission (EEOC). (2021, May 28). What
You Should Know About COVID-19 and the ADA, the Rehabilitation Act,
and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. (EEOC,
May 28, 2021).
Internal Revenue Service (IRS). (2021, April). Under the American
Rescue Plan, employers are entitled to tax credits for providing
paid leave to employees who take time off related to COVID-19
vaccinations. FS-2021-09. https://www.irs.gov/newsroom/employer-tax-credits-for-employee-paid-leave-due-to-covid-19. (IRS, April 2021).
L. Vaccination
Vaccination is a vital tool that will help reduce the presence and
severity of COVID-19 cases in the workplace. As discussed further in
Need for Specific Provisions (Section V of the preamble), vaccination
protects employees from developing COVID-19, or from developing a
severe case of the disease if they do contract it. The CDC has also
determined that vaccination may reduce the risk that the vaccinated
person will transmit COVID-19 to another person, such as to other
employees (CDC, April 2, 2021; CDC, April 12, 2021). Despite the robust
protection against COVID-19 that vaccination affords, many individuals
have not yet received the vaccine, including a disproportionate number
of Black and Latinx people (CDC, May 24, 2021). Of those people who
have not yet been vaccinated, at least some are hesitant to receive the
vaccine. For example, the U.S. Census Bureau reported that, as of April
26, 2021, 18.2% of U.S. adults age 18 or older were unsure if they
would receive a COVID-19 vaccine, or would ``definitely not'' or
``probably not'' receive a COVID-19 vaccine (U.S. Census Bureau, May 5,
2021). Additionally, in a March 2021 survey, McKinsey & Company found
that 15% of respondents stated that they were unlikely to get
vaccinated (Azimi et al., April 9, 2021). Despite their increased risk
of exposure to the virus, some healthcare workers are hesitant to
receive a COVID-19 vaccine. As early as December 2020, a survey found
that 15% of healthcare workers who were offered a COVID-19 vaccine
refused to take one (Surgo, January 2021). Similarly, in a survey of
healthcare workers conducted from early January to late February 2021,
15% responded that they would ``definitely not'' or ``probably not''
receive a COVID-19 vaccine (The Delphi Group, March 12, 2021). More
recently, a poll conducted in February and early March 2021 by the
Kaiser Family Foundation (KFF) and the Washington Post found that 30%
of front-line healthcare workers were either unsure about getting
vaccinated or not planning to do so (KFF and Washington Post, March
2021; Wan et al., March 19, 2021).
Vaccine hesitancy is attributable to several factors, but a
principal driver of vaccine hesitancy among healthcare
workers is concern about potential side effects. In the Delphi Group
survey, more than 70% percent of vaccine-hesitant healthcare workers
stated that they were concerned about a side effect (The Delphi Group,
March 12, 2021). In the KFF/Washington Post survey, 82% of vaccine-
hesitant healthcare workers responded that concern about potential side
effects was a major factor in their decision-making (KFF and Washington
Post, March 2021).
Although an individual's decision to receive or not receive a
COVID-19 vaccination may turn on several considerations, removing
logistical barriers to obtaining vaccination is key to encouraging
workers to choose vaccination. One such barrier for many employees is
concerns about taking time off of work to receive the vaccine and
recover from any potential side effects (SEIU Healthcare, February 8,
2021). In a survey conducted of unvaccinated adults in April 2021, 48%
of respondents said that they were very or somewhat concerned that they
might miss work if the vaccine side effects make them feel sick, and
20% said they were very or somewhat concerned that they may need to
take time off to go and get the vaccine (KFF, May 6, 2021). Black and
Hispanic adults were particularly worried about the potential time
necessary to recover from vaccine side effects, with 64% of
unvaccinated Hispanic adults and 55% of unvaccinated Black adults
expressing concern that they might have to miss work due to the side
effects of a COVID-19 vaccine. According to a recent study, Black and
Hispanic workers constitute nearly 30% of the healthcare workforce (Rho
et al., April 2020). In the McKinsey survey, 12% of respondents stated
that the time away from work to be vaccinated or due to side effects is
a barrier to vaccination (Azimi et al., April 9, 2021). Recent news and
journal articles further evince this concern (e.g., Cleveland
Documenters, 2021; Roy et al., December 29, 2020).
To address this barrier to vaccination, while also promoting a more
equitable delivery of vaccines, paragraph (m) provides that employers
must support COVID-19 vaccination for each employee through reasonable
time off and paid leave (e.g., paid sick leave, administrative leave,
etc.) for the full vaccination series (i.e., each required dose) and
any side effects experienced following vaccination. OSHA finds that
requiring employers to support employee vaccination through reasonable
time and paid leave will encourage employee vaccinations and thereby
help ensure effective protection against COVID-19 at the workplace. In
the KFF survey, 28% of unvaccinated respondents who did not want to get
the vaccine as soon as possible said that they would be more likely to
obtain vaccination if their employer gave them paid time off to get
vaccinated and recover from any side effects (KFF, May 6, 2021).
Additionally, McKinsey found from its survey that paid time off for
vaccination and the recovery period post-vaccination was the single
most-influential action for encouraging employee vaccination, with 75%
of respondents indicating that such paid time off would significantly
or moderately increase the likelihood that they would get vaccinated
(Azimi et al., April 9, 2021). The KFF and Washington Post survey
further evinces that this support is needed in the healthcare industry;
12% of non-self-employed healthcare workers stated that their employer
was falling short in ensuring that employees have the ability to get
vaccinated, and 33% of such workers stated that their employer was
falling short in providing paid sick leave for employees who have
COVID-19, which supports an inference that at least some healthcare
workers also lack paid sick leave to recover from the side effects of a
COVID-19 vaccine dose (KFF and Washington Post, March 2021).
Paid time off for vaccination may be particularly critical at this
stage in the pandemic for employees in long-term health care and home
health care. The Pennsylvania Homecare Association surveyed its members
in March and found that ``56% of employees wanted the vaccine--up from
50% in January--but only 32% had been able to get it.'' (Burling, March
28, 2021).
Under paragraph (b), the term vaccine, as used in this ETS, is
defined as a biological product authorized or licensed by the FDA to
prevent or provide protection against COVID-19, whether the substance
is administered through a single dose or a series of doses. As of May
1, 2021, there are three vaccines authorized by the FDA for emergency
use to prevent COVID-19 that therefore meet the definition of COVID-19
vaccine as used in this ETS: The Pfizer-BioNTech vaccine, the Moderna
vaccine, and the Johnson & Johnson (Janssen) vaccine, which received
Emergency Use Authorizations (EUA) on December 11, 2020, December 18,
2020, and February 27, 2021, respectively (CDC, March 3, 2021; Oliver
et al., December 18, 2020; Oliver et al., January 1, 2021; McClung et
al., November 27, 2020; FDA, December 2020; FDA, January 2021; FDA,
February 27, 2021). Any vaccine subsequently authorized or licensed for
use by the FDA would also meet the definition of vaccine used in this
standard. The definition of vaccine includes substances that are
administered through a single dose or a series of doses. Therefore,
when more than one dose is required by the FDA for a particular type of
vaccine, all the requirements discussed below apply to the entire
series of doses. Currently, the Pfizer-BioNTech and Moderna vaccines
require a series of two doses, and the Johnson & Johnson (Janssen)
vaccine only requires one dose.
Paragraph (m) requires that employers support COVID-19 vaccination
for their employees by making reasonable time and paid leave available
to the employee for vaccination and recovery from any side effects.
Reasonable time may include, but is not limited to, time spent during
work hours related to the vaccination appointment(s), such as
registering, completing required paperwork, all time spent at the
vaccination site (e.g., receiving the vaccination dose, post-
vaccination monitoring by vaccine provider), and time spent traveling
to and from the location for vaccination (including travel to an off-
site location (e.g., a pharmacy), or situations in which an employee
working remotely (e.g., telework) or in an alternate location must
travel to the workplace to receive the vaccine). Paid leave provided
may include paid sick leave or administrative leave. The paid leave can
be in the form of an employee's accrued sick leave, if available, or in
additional paid leave provided by the employer for this purpose. Paid
leave for vaccination purposes generally can be recovered by an
employer with fewer than 500 employees as a tax credit under the leave
provisions of the ARP (IRS, April 2021).
Employers may set a cap on the amount of time and paid leave
available to employees to receive each dose of the vaccine and to
recover from any side effects, but the cap must be reasonable.
Accordingly, the amount of reasonable time and paid leave that an
employer must make available to employees may vary depending on the
circumstances. Generally, OSHA presumes that, if an employer makes
available up to four hours of paid leave for each dose of the vaccine,
as well as up to 16 additional hours of leave for any side effects of
the dose(s) (or 8 hours per dose), the employer would be in compliance
with this requirement. OSHA understands that employers may be able to
provide much less than four hours if employees do not need to travel
for vaccinations, for example, if they are provided onsite.
Employers must make reasonable time and paid leave available for
employees to receive all vaccination doses during work hours. If an
employee chooses to receive the vaccine outside of work hours,
employers are not required to grant time and paid leave for the time
that the employee spent receiving the vaccine during non-work hours.
However, even if employees receive the vaccine outside of work hours,
employers must still afford them reasonable time and paid leave to
recover from any side effects that they experience during scheduled
work time.
An employer may make some effort to facilitate voluntary
vaccination of its employees by, for example, hosting a vaccine clinic
at the workplace (e.g., mobile trailer) or partnering with another
entity, such as a pharmacy or healthcare provider, so that employees
can be vaccinated at the workplace or at an off-site location. If an
employer chooses to make the vaccine available to its employees, it
must support full vaccination (i.e., provide both doses in a
vaccination series, if applicable), again by assuring the availability
of reasonable time and paid leave to each employee to receive the full
vaccination series and recover from any side effects they may
experience. Any additional costs incurred by the employer to bring
vaccination on-site would, likewise, have to be covered by the
employer, though such an approach would likely require fewer paid leave
hours for vaccine administration (but not side effects), because of
reduced travel time.
As discussed in the Summary and Explanation for requirements
implemented at no cost to employees (paragraph (p)), the employer is
responsible for all costs associated with implementing the requirements
of the standard, including the costs of complying with the vaccination
support requirement. The employer must pay employees for reasonable
time spent receiving a vaccination during work hours, including any
time spent on required paperwork, vaccine administration, post-
vaccination monitoring, and travel time. The employer must also pay
employees for reasonable time spent recovering from any side effects
that they experience as a result of vaccination. However, to align the
provision with the tax incentives of the ARP, employers are not
obligated to reimburse employees for transportation costs (e.g., gas
money, train/bus fare, etc.) incurred to receive the vaccination, such
as the costs of travel to an off-site vaccination location (e.g., a
pharmacy), or travel from an alternate work location (e.g., telework)
to the workplace to receive a vaccination dose. Paid leave provided may
include paid sick leave or administrative leave.
Paragraph (m) does not require employees to be vaccinated for
COVID-19. Employers should consult applicable law and/or labor
management contracts concerning employee vaccination. While OSHA
encourages all eligible employees to take advantage of the protection
offered by vaccination, the agency recognizes that some employees may
decline vaccination for a number of reasons, including underlying
medical conditions or conscience-based objections (moral or religious).
At the same time, nothing in the ETS precludes an employer from taking
steps beyond the requirements of this standard to encourage employees
to get vaccinated, as appropriate under applicable laws and/or labor
management contracts. The EEOC provides guidance on COVID-19
vaccination as it relates to equal employment opportunity laws (EEOC,
May 28, 2021).
References
Azimi, T et al., (2021, April 9). Getting to work: Employers' role
in COVID-19 vaccination. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/getting-to-work-employers-role-in-covid-19-vaccination#. (Azimi, April 9, 2021).
Burling, S. (2021, March 28). Medical providers still struggle to
convince some workers to get COVID-19 vaccine. The Philadelphia
Inquirer. https://www.inquirer.com/health/coronavirus/some-health-care-employee-vaccination-rates-are-still-low-20210328.html.
(Burling, March 28, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 3).
How CDC Is Making COVID-19 Vaccine Recommendations. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html. (CDC, March 3, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 2).
Science Brief: Background rationale and evidence for public health
recommendations for fully vaccinated people. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. (CDC, April 2, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 12).
Benefits of getting a COVID-19 vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits.html?s_cid=11236:should%20i%20take%20the%20covid%20vaccine:s
em.ga:p:RG:GM:gen:PTN:FY21. (CDC, April 12, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 24).
Demographic Trends of People Receiving COVID-19 Vaccinations in the
United States. https://covid.cdc.gov/covid-data-tracker/?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fcases-updates%2Fcas%E2%80%A6#vaccination-demographic. (CDC,
May 24, 2021).
Cleveland Documenters. (2021). Why some Clevelanders are still on
the fence or not getting vaccinated: Voices on the vaccine. The
Cleveland Observer. https://www.theclevelandobserver.com/blog/2021/04/22/why-some-clevelanders-are-still-on-the-fence-or-not-getting-vaccinated-voices-on-the-vaccine/. (Cleveland Documenters, 2021).
The Delphi Group at Carnegie Mellon University in partnership with
Facebook. (2021, March 12). Topline Report on COVID-19 Vaccination
in the United States. https://www.cmu.edu/delphi-web/surveys/CMU_Topline_Vaccine_Report_20210312.pdf. (Delphi Group, March 12,
2021).
Equal Employment Opportunity Commission (EEOC). (2021, May 28). What
You Should Know About COVID-19 and the ADA, the Rehabilitation Act,
and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. (EEOC,
May 28, 2021).
Food and Drug Administration (FDA). (2020, December). Fact Sheet for
Recipients and Caregivers. Emergency Use Authorization (EUA) of the
Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-
19) in individuals 18 Years of Age or Older. https://www.fda.gov/media/144638/download. (FDA, December 2020).
Food and Drug Administration (FDA). (2021, January). Fact Sheet for
Recipients and Caregivers. Emergency Use Authorization (EUA) of the
Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019
(COVID-19) in individuals 16 Years of Age or Older. https://www.fda.gov/media/144414/download. (FDA, January 2021).
Food and Drug Administration (FDA). (2021, February 27). FDA Issues
Emergency Use Authorization for Third COVID-19 Vaccine. https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine. (FDA, February 27, 2021).
Internal Revenue Service (IRS). (2021, April). Under the American
Rescue Plan, employers are entitled to tax credits for providing
paid leave to employees who take time off related to COVID-19
vaccinations. FS-2021-09. https://www.irs.gov/newsroom/employer-tax-credits-for-employee-paid-leave-due-to-covid-19. (IRS, April 2021).
Kaiser Family Foundation (KFF). (2021, May 6). KFF COVID-19 Vaccine
Monitor: April 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/. (KFF, May 6,
2021).
Kaiser Family Foundation (KFF) and Washington Post. (2021, March).
KFF and Washington Post Frontline Health Care Workers Survey.
https://context-cdn.washingtonpost.com/notes/prod/
default/documents/4d8d1ddf-c192-40f9-9e3a-7a3fefa0d928/note/
91e5f1ac-2cc5-41bb-b164-ecb4d77ed0b5.#page=1. (KFF and Washington
Post, March 2021).
McClung, N et al., (2020, November 27). The Advisory Committee on
Immunization Practices' Ethical Principles for Allocating Initial
Supplies of COVID-19 Vaccine--United States, 2020. MMWR 69: 1782-
1786. DOI: http://dx.doi.org/10.15585/mmwr.mm6947e3. (McClung et
al., November 27, 2020).
Oliver, S et al., (2020, December 18). The Advisory Committee on
Immunization Practices' interim recommendation for use of Pfizer-
BioNTech COVID-19 vaccine--United States, December 2020. MMWR Rep
2020; 69: 1922-1924. DOI: http://dx.doi.org/10.15585/mmwr.mm6950e2.
(Oliver et al., December 18, 2020).
Oliver, S et al., (2020, December 20). The Advisory Committee on
Immunization Practices' interim recommendation for use of Moderna
COVID-19 vaccine--United States, December 2020. MMWR Rep 2021; 69:
1653-1656. DOI: http://dx.doi.org/10.15585/mmwr.mm695152e1. (Oliver
et al., January 1, 2021).
Rho, HJ et al., (2020, April). A Basic Demographic Profile of
Workers in Frontline Industries. Center for Economic and Policy
Research. https://cepr.net/wp-content/uploads/2020/04/2020-04-Frontline-Workers.pdf. (Rho et al., April 2020).
Roy, B et al., (2020, December 29). Health Care Workers' Reluctance
to Take the COVID-19 Vaccine: A Consumer-Marketing Approach to
Identifying and Overcoming Hesitancy. NEJM Catalyst https://catalyst.nejm.org/doi/pdf/10.1056/CAT.20.0676. (Roy et al., December
29, 2020).
SEIU Healthcare. (2021, February 8). Research shows 81% of
healthcare workers willing to take COVID-19 vaccines but personal
financial pressures remain a significant barrier for uptake. https://www.newswire.ca/news-releases/research-shows-81-of-healthcare-workers-willing-to-take-covid-19-vaccines-but-personal-financial-pressures-remain-a-significant-barrier-for-uptake-888810789.html.
(SEIU Healthcare, February 8, 2021).
Surgo Ventures. (2021, January). U.S. Healthcare Workers: COVID-19
Vaccine Uptake & Attitudes. https://surgoventures.org/resource-library/survey-healthcare-workers-and-vaccine-hesitancy. (Surgo,
January 2021).
U.S. Census Bureau. (2021, May 5). Household Pulse Survey COVID-19
Vaccination Tracker. https://www.census.gov/library/visualizations/interactive/household-pulse-survey-covid-19-vaccination-tracker.html. (U.S. Census Bureau, May 5, 2021).
Wan, W et al., (2021, March 19). More than 4 in 10 health-care
workers have not been vaccinated, Post-KFF poll finds. The
Washington Post. https://www.washingtonpost.com/health/2021/03/19/health-workers-covid-vaccine/. (Wan et al., March 19, 2021).
M. Training
Training is critical to controlling the spread of COVID-19 in the
workplace and an important component of the COVID-19 program required
by this ETS. Paragraph (c) requires employers to develop and implement
workplace-specific COVID-19 plans. As part of developing their plans,
employers must conduct a hazard assessment to identify potential
workplace hazards related to COVID-19. This hazard assessment will help
employers identify the specific hazards their employees face and ensure
the employers' COVID-19 plans are appropriately tailored to the
workplace. The hazard assessment will also help employers develop
workplace-specific policies and procedures to mitigate the risk of
COVID-19 transmission. Training on these policies and procedures is an
essential part of this ETS because it helps to ensure that employees
understand the sources of potential exposure to COVID-19, the
workplace-specific control measures implemented to reduce exposure to
the hazard, and the requirements of this ETS. The effectiveness of the
ETS would be undermined if employees did not have sufficient knowledge
and understanding of all aspects of the COVID-19 policies and
procedures implemented by their employers for recognizing and
preventing potential occupational exposures to COVID-19.
Accordingly, paragraph (n)(1) requires employers to provide
training to each employee. The training employers provide pursuant to
this paragraph must be in a language and at a literacy level the
employee understands. Additionally, the employer must ensure the
employee comprehends all of the training elements required in this
paragraph. If an employer has employees that speak different languages
or are at different literacy levels, the employer must ensure all
training materials are presented in a way that each employee can
understand. This may require an employer to create different training
materials for different groups of employees (e.g., materials in
different languages). When translation of training materials is
required, employers must ensure the translation is one the employees
can clearly understand. Training employees in a manner they understand
enables employees to maximize the effectiveness of the workplace
controls they utilize and helps ensure that the employer's training
program is successful. Employers must provide reasonable accommodation,
as required by the Americans with Disabilities Act, if needed by an
employee with a disability.
The implementation of training programs, including how training is
conducted and by whom, may vary based on the size and type of workplace
or business, and employers have some flexibility to adapt training to
their specific workplace. However, employers must ensure each of their
employees comprehends the training elements required in this ETS. Those
key elements are listed in paragraphs (n)(1)(i)-(xii). Employers can
offer training in a variety of formats, including online, virtual,
instructor-led, or application-based methods, but employers must ensure
that employees comprehend the training materials and that they have an
opportunity to get answers to their questions (see paragraph (n)(4)).
Following training, employees must be able to demonstrate their
understanding of the materials. There are different ways employers can
ensure comprehension of the training materials, including a knowledge
check (e.g., written or oral assessment) or discussion after the
training. Post-training assessments may be particularly useful for
ensuring employee participation and comprehension when employers offer
online training.
Paragraph (n)(3) requires employers to ensure training is overseen
or conducted by a person knowledgeable in the covered subject matter as
it relates to the employee's job duties. This individual must be
knowledgeable about the various requirements described in this section,
including all provisions within paragraph (n), as well as infection
control policies and procedures. Additionally, paragraph (n)(4)
requires employers to ensure training provides an opportunity for
interactive questions and answers with a person knowledgeable in the
covered subject matter as it relates to the employee's job duties. For
example, an employer could utilize a virtual or online training but
would need to ensure that training includes the ability to ask
questions and receive answers. In order to ensure that employees
comprehend the material presented during training, it is critical that
employees have the opportunity to ask questions and receive answers
promptly. When video- or computer-based trainings are used, this may
require the employer to make available a qualified trainer to address
questions after the training, or to offer a telephone hotline where
employees can ask questions.
Paragraph (n)(1)(i) requires employers to provide a general
explanation of COVID-19, including how the disease is transmitted
(including pre-symptomatic
and asymptomatic transmission), the importance of hand hygiene to
reduce the risk of spreading COVID-19 infections, ways to reduce the
risk of spreading COVID-19 through the proper covering of the nose and
mouth, the signs and symptoms of the disease, risk factors for severe
illness, and when to seek medical attention, as part of their training
materials. Additional information about COVID-19 that may aide
employers in providing this portion of the training can be found in
Grave Danger (Section IV.A. of the preamble) and in COVID-19-related
guidance from the CDC (CDC, February 22, 2021; CDC, March 17, 2021;
CDC, January 8, 2021; CDC, April 22, 2020; CDC, November 24, 2020; CDC,
May 13, 2021a; CDC, May 13, 2021b). Employers should stay updated and
inform employees on the latest guidance from the CDC related to COVID-
19 to ensure that their training features the most up-to-date
information available.
Paragraph (n)(1)(ii) requires employers to provide training on
employer-specific policies and procedures on patient screening and
management. This training must cover the patient screening and
management requirements under paragraph (d), including how patient
screening will occur. More information about employers' patient
screening and management obligations can be found in the Summary and
Explanation for Patient Screening and Management.
Paragraph (n)(1)(iii) requires employers to provide employees with
an explanation of the tasks and situations in the workplace that could
result in potential COVID-19 infection. Employees' job duties affect
their level of occupational risk. Therefore, employee training will
vary based on the workplace and the employee's job duties. Occupational
risk may also change as employees take on different tasks, requiring
the employer to provide additional training. For example, if cross-
training on multiple job tasks or functions is occurring due to
increased employee shortages and absenteeism related to COVID-19
illness, quarantine, or isolation, employers must ensure that each
employee receives training about potential COVID-19 exposure for all
job tasks and duties they are asked to engage in. The hazard
assessments required by paragraph (c)(4)(i) will help employers
determine employees' potential workplace exposure to COVID-19 and,
consequently, the training they will need to receive.
OSHA recognizes that COVID-19 control practices rely upon a multi-
layered and overlapping strategy of controls. Thus, paragraph
(n)(1)(iv) requires employers to provide training on all workplace-
specific policies and procedures to prevent the spread of COVID-19 that
are applicable to the employee's duties. This may include training on
policies and procedures related to physical distancing, physical
barriers, Standard and Transmission-Based Precautions, ventilation,
aerosol-generating procedures, and other COVID-19-related control
measures in the workplace. Employees play a particularly important role
in reducing exposures because appropriate application of work practices
and controls determines exposure levels. As such, training in those
practices and controls is necessary for employees to implement them
effectively.
OSHA recognizes that there are a number of different types of
multi-employer arrangements in healthcare settings (e.g., contracted
healthcare providers, licensed independent practitioners with
privileges to practice in various workplaces). To ensure employees are
adequately protected from COVID-19 exposure in multi-employer
workplaces, paragraph (n)(1)(v) requires employers to train employees
on employer-specific multi-employer workplace agreements related to
infection-control policies and procedures, the use of common areas, and
the use of shared equipment that affect employees at the workplace.
Common areas, as defined in paragraph (b), are indoor or outdoor
locations under the control of the employer that more than one person
may use or where people congregate (e.g., building lobbies, reception
areas, waiting rooms, restrooms, break rooms, eating areas, conference
rooms).
Paragraph (f) of the ETS contains PPE requirements associated with
COVID-19. Paragraph (n)(1)(vi) requires employers to provide training
on employer-specific policies and procedures for PPE worn to comply
with this ETS. Specifically, paragraphs (n)(1)(vi)(A)-(D) mandate that
this training cover: When PPE is required for protection against COVID-
19; limitations of PPE for protection against COVID-19; how to properly
put on, wear, and take off PPE; and how to properly care for, store,
clean, maintain, and dispose of PPE. Additionally, paragraph
(n)(1)(vi)(E) requires that employers provide training on any
modifications to donning, doffing, cleaning, storage, maintenance, and
disposal procedures needed to address COVID-19 when PPE is worn to
address workplace hazards other than COVID-19. This means that when
employees are using PPE for non-COVID-19 occupational hazards,
employers must train those employees on how to prevent the transmission
of COVID-19 associated with their use of that PPE. The Summary and
Explanation for Personal Protective Equipment provides additional
information on PPE requirements.
Paragraph (n)(1)(vii) requires employers to train each employee on
workplace-specific policies and procedures for cleaning and
disinfection. This training must be consistent with the cleaning and
disinfection requirements in paragraph (j). Training must include
instruction on the proper and safe use of cleaning and disinfection
supplies provided by the employer. For example, if an employee is
tasked with cleaning high-touch surfaces in the lobby of a long-term
care center, the employer must train the employee on which supplies to
use, as well as how to properly and safely use those supplies.
Certain tasks may require employers to provide employees additional
training related to cleaning and disinfection. For example, paragraph
(j)(2)(ii) requires employers to clean and disinfect materials, areas,
and equipment that have likely been contaminated by a person who is
COVID-19-positive, in accordance with CDC guidance. Employers must
ensure employees tasked with cleaning and disinfecting those materials,
areas, and equipment receive training on the cleaning and disinfection
protocols established in accordance with the CDC guidance.
Additionally, under paragraph (j)(1), in patient care areas, resident
rooms, and for medical devices and equipment, employers must follow
standard practices for cleaning and disinfection of surfaces and
equipment in accordance with applicable CDC guidelines. Therefore,
employers must train employees tasked with cleaning and disinfecting
those areas and surfaces in accordance with the CDC guidance.
Additional information regarding cleaning and disinfection is available
in the Summary and Explanation for Cleaning and Disinfection.
Paragraph (n)(1)(viii) requires employers to train employees on all
employer-specific policies and procedures for health screening and
medical management. This training must cover all health screening and
medical management requirements under paragraph (l), including when and
how health screening will occur, what the screening will include, and
how frequently employees will be screened. It is particularly important
that employees are informed about the requirement that they notify
their
employer of COVID-19 illness or symptoms, as described in paragraph
(l)(2). Additionally, employees must receive training on how and when
their employer will notify them of workplace exposures, as described in
paragraph (l)(3). Employees must be informed that these notifications
will contain only the information necessary to provide notice of
potential workplace exposures (e.g., the fact that a close contact
occurred or could have occurred, the date(s), and the general
location(s)). Employees must also be informed that these notifications
will not include the name, contact information (e.g., phone number,
email address), or occupation of the employee who is COVID-19 positive.
Additional information about appropriate information to be included in
the notifications required by paragraph (l)(3) can be found in the
Summary and Explanation for Health Screening and Medical Management.
Employees must also receive training on the situations in which removal
from the workplace is required and when employees who have been removed
can return to work, as described in paragraphs (l)(4) and (l)(6).
Further, training must be provided on the medical removal protection
benefits required by paragraph (l)(5). Additional information about
employer requirements related to health screening and medical
management can be found in the Summary and Explanation for Health
Screening and Medical Management.
Paragraph (n)(1)(ix) requires that employers provide training on
available sick leave policies, any other COVID-19-related benefits to
which the employee may be entitled to under applicable federal, state,
or local laws, and other supportive policies and practices. Employers
must train employees on their company sick leave policies. Employers
should consider implementing sick leave policies that are flexible,
consistent with public health guidance, and encourage potentially
contagious employees to stay home. Employers must also train employees
on any federal, state, or local laws under which they may be entitled
to COVID-19-related benefits. Other examples of potential supportive
policies and practices could include: coordinating leave policies with
businesses that provide your workplace with contract or temporary
employees; maintaining flexible leave policies for those caring for
sick household members or with child care responsibilities; providing
telework and flexible workday options; and communicating with insurance
companies to provide information to employees about medical care in the
event of a COVID-19 outbreak.
OSHA believes that it is important for employees to be familiar
with the ETS and have access to relevant employer-specific policies and
procedures in order to comply. Thus, paragraph (n)(1)(x) requires
employers to identify the safety coordinator(s) specified in the COVID-
19 plan as part of employees' training so they know who to contact with
questions or concerns. Additionally, paragraph (n)(1)(xi) requires
employers to train employees on the requirements of this ETS. For
example, employees must be informed that they will be provided
reasonable time and paid leave for vaccination and any side effects
experienced following vaccination, as required by paragraph (m).
Furthermore, paragraph (n)(1)(xii) requires that employees be informed
about how to obtain a copy of this ETS, as well as any relevant
employer-specific policies and procedures developed under this ETS,
including the employer's written COVID-19 plan, if a written plan is
required.
Prior to the effective date of this ETS, some employers likely
provided some training to their employees in response to the ongoing
COVID-19 pandemic. As explained in the note to paragraph (n)(1),
employers may rely on that training to the extent that it meets the
relevant training requirements under paragraph (n). However, if an
employer intends to rely on training already provided to satisfy its
training requirements under this ETS, then it must review and evaluate
the training already provided and determine whether it covers all of
the training requirements under this section. If the previous training
is missing any of the required elements, then the employer must train
its employees on those elements to come into compliance with the ETS.
For example, if an employer has already provided recent training on the
modes of transmission of COVID-19, the employer would not need to
conduct that part of the training again to meet its initial training
requirements under this ETS. Thus, the employer would not be required
to expend resources to meet a requirement it has already met. However,
the employer would need to provide training to its employees that
satisfies the other requirements in paragraph (n).
Paragraph (n)(2), requires employers to provide additional training
when changes occur related to the employee's risk of contracting COVID-
19 at work, when policies or procedures change, and when there is an
indication that the employee has not retained the necessary
understanding or skill. Both initial and supplemental employee training
(under paragraphs (n)(1) and (n)(2), respectively) are important
components of an effective approach to controlling the spread of COVID-
19. Initial training provides employees with the knowledge and skills
they will need to protect themselves against occupational exposure.
Initial training also emphasizes the importance of following workplace
policies and procedures to mitigate the spread of COVID-19.
Supplemental training is important to ensure employees continue to have
the knowledge and skills they need to protect themselves as conditions
change. Frequent review and updates to training are especially
important under this ETS as more information about COVID-19, as well as
updated medical recommendations and public health practices in relation
to preventing COVID-19 transmission, become available.
Paragraph (n)(2)(i) requires additional training when changes occur
that affect the employee's risk of contracting COVID-19 at work. For
example, changing outbreak conditions in a community may directly
affect an employee's exposure risks for contracting COVID-19, including
at work. Therefore, additional training would be necessary when newly-
available information from the CDC, WHO, OSHA, or local public health
departments renders prior training inadequate or outdated to protect
employees from COVID-19 (e.g., new information on how COVID-19 is most
likely to be transmitted). Additionally, if an employer assigns an
employee new or different job tasks, that employee may be exposed to
new COVID-19 hazards at work and additional training would be required.
Paragraph (n)(2)(ii) requires additional training when policies or
procedures are changed. Therefore, if the employer alters its workplace
policies and procedures related to COVID-19, employees must receive
training on those particular changes. For example, under paragraph (c),
employers must monitor the workplace to ensure the ongoing
effectiveness of their COVID-19 plans and update them as needed. When
monitoring the workplace, the employer may find that the COVID-19 plan
must be updated to better address the COVID-19 transmission risks its
employees are exposed to. Employees must receive training on any new or
altered policies and procedures that the employer implements as a
result. Such additional training ensures that employees are able to
actively participate in protecting themselves from COVID-19 exposure in
the workplace when policies and procedures change.
Paragraph (n)(2)(iii) requires employers to provide additional
training to an employee when there is an indication that the employee
has not retained the necessary understanding or skill. For example, if
an employer observes employees not wearing PPE or wearing it
improperly, not correctly practicing physical distancing, or not
appropriately using physical barriers, the employer would have an
indication that the employees have not retained their understanding of
the necessary training elements. In such cases, the employer would need
to provide additional training to the employees. However, where the
employer discovers that the employee understands a particular workplace
rule (such as wearing a facemask) but is nonetheless willfully not
complying with it, retraining is not necessary if the employer takes
steps to enforce the rule.
Training and information requirements are routine components of
OSHA standards (OSHA, 2015). The inclusion of training and information
requirements reflects the agency's conviction, as noted above, that
informed employees are essential to the implementation of any effective
occupational safety and health policies and procedures, and employer
safety and health programs. OSHA believes that informing and training
employees about the COVID-19 hazards to which they are potentially
exposed will contribute substantially to reducing the incidence of
infections caused by workplace exposure to COVID-19.
References
Centers for Disease Control and Prevention (CDC). (2020, April 22).
Coughing and Sneezing. https://www.cdc.gov/healthywater/hygiene/etiquette/coughing_sneezing.html. (CDC, April 22, 2020).
Centers for Disease Control and Prevention (CDC). (2020, November
24). When and How to Wash Your Hands. https://www.cdc.gov/handwashing/when-how-handwashing.html. (CDC, November 24, 2020).
Centers for Disease Control and Prevention (CDC). (2021, January 8).
Handwashing. https://www.cdc.gov/coronavirus/2019-ncov/global-covid-19/handwashing.html#print. (CDC, January 8, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
22). Symptoms of Coronavirus. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. (CDC, February 22, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 17).
What to Do If You Are Sick. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html. (CDC, March 17, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, May 13).
How COVID-19 Spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 13).
People with Certain Medical Conditions. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. (CDC, May 13, 2021b).
Occupational Safety and Health Administration (OSHA). 2015. Training
Requirements in OSHA Standards. https://www.osha.gov/Publications/osha2254.pdf. (OSHA, 2015).
N. Anti-Retaliation
Paragraph (o) includes provisions to ensure employees are aware of
their rights under the standard, and that they are protected from
retaliation for exercising those rights. Specifically, the paragraph
requires that employers inform each employee of their right to the
protections required by the standard (see paragraph (o)(1)(i)).
Employers are also required to inform each employee of the prohibition
on employers discharging or in any manner discriminating against any
employee for exercising their right to the protections required by the
standard, or for engaging in actions that are required by the standard
(see paragraph (o)(1)(ii)). In addition, it explicitly prohibits
employers from discharging or in any manner discriminating against any
employee for exercising their right to the protections required by the
standard, or for engaging in actions that are required by the standard
(see paragraph (o)(2)).
OSHA's authority to promulgate the anti-retaliation provision of
the ETS stems from section 6(c) of the Act, which requires the Agency
to promulgate an ETS when necessary to protect employees from grave
danger posed by a new hazard such as COVID-19. Once OSHA has
established as a threshold matter, based on substantial evidence in the
record, that an ETS is necessary to protect employees from COVID-19,
OSHA has almost ``unlimited discretion'' to devise the means to achieve
that goal and need only demonstrate that each specific provision of the
standard is ``reasonably necessary'' to protect employees from exposure
to COVID-19. See United Steelworkers of Am. v. Marshall, 647 F.2d 1189,
1230, 1237, 1241 (D.C. Cir. 1981); see also Forging Industry Ass'n v.
Sec'y of Labor, 773 F.2d 1436, 1447 (4th Cir. 1985).
The anti-retaliation provision in paragraph (o) is a reasonably
necessary component of the ETS because employee participation--such as
staying home when they test positive for COVID-19 to protect others,
maintaining physical distancing, and alerting the employer to COVID-19
hazards--is critical to mitigating the spread of COVID-19 at the
workplace, and fear of retaliation would undermine the effectiveness of
the ETS. Although anti-retaliation protections may not be integral to
all OSHA standards given the statutory bar on retaliation under section
11(c) of the OSH Act (29 U.S.C. 660(c)(1)), anti-retaliation
protections are especially critical to the effectiveness of the ETS
because of the emergency nature of the COVID-19 pandemic and the
central role employee participation plays in effectuating the ETS's
purpose.
This is not the first time OSHA has implemented explicit anti-
retaliation protections in a regulation where such protections were
necessary to effectuate the purposes of the OSH Act. In 2016, OSHA
amended its Recordkeeping regulation to require certain employers to
report data from their OSHA injury and illness records to OSHA
electronically each year, and to ensure the accuracy of those records
consistent with the Agency's authority under sections 8 and 24 of the
Act (29 U.S.C. 657, 673), the regulation included a prohibition on
retaliating against employees for reporting work-related injuries and
illnesses. See Improve Tracking of Workplace Injuries and Illnesses, 81
FR 29624, 29627 (May 12, 2016); codified at 29 CFR 1904.35. In that
rulemaking, OSHA received numerous comments indicating that fear of
retaliation motivated employees to conceal work-related injuries and
illnesses from their employers. See 81 FR at 29670. Similar concerns
are implicated here, where fear of retaliation could motivate employees
to conceal information or refrain from taking action critical to
mitigating the spread of COVID-19 in the workplace, such as reporting
their COVID-19 status to their employer and staying home from work
after testing positive, and alerting the employer to COVID-19 hazards
in the workplace. In enforcement proceedings before the Occupational
Safety and Health Review Commission, two administrative law judges have
upheld OSHA's authority to promulgate the anti-retaliation provision of
its Recordkeeping regulation, 29 CFR 1904.35(b)(1)(iv). Sec'y of Labor
v. U.S. Postal Service, No. 18-0188, 2020 WL 4514847, at *14-17
(May 18, 2020), set aside on other grounds, 2020 WL 4514846 (July 28,
2020) (holding that the regulation was validly promulgated and citing
an order of another ALJ reaching the same conclusion). A facial
challenge to the validity of the Recordkeeping rule's anti-retaliation
provision is pending in the U.S. District Court for the Western
District of Oklahoma. See Nat'l Ass'n of Home Builders v. Acosta, CIV-
19-009-PRW (W.D. Okla., Jan. 4, 2017).
The anti-retaliation provision of the ETS partially overlaps with
the statutory retaliation bar in section 11(c)(1) of the OSH Act, 29
U.S.C. 660(c)(1), which provides no person shall discharge or in any
manner discriminate against any employee because such employee has
filed any complaint or instituted or caused to be instituted any
proceeding under or related to [the OSH] Act or has testified or is
about to testify in any such proceeding or because of the exercise by
such employee on behalf of himself or others of any right afforded by
[the] Act.
But the fact that the anti-retaliation provision in the ETS
dovetails with the anti-retaliation goals of section 11(c) does not
limit OSHA's authority to promulgate it. See United Steelworkers, AFL-
CIO v. St. Joe Resources, 916 F.2d 294, 296-98 (5th Cir. 1990) (holding
that section 11(c) is not an exclusive remedy, and OSHA had the
authority to order back pay to remedy a violation of OSHA's Lead
standard even where section 11(c) would require the same relief). And,
to the extent the OSH Act may not unambiguously resolve this question,
OSHA's interpretation of section 6(c) as authorizing the Agency to
promulgate the anti-retaliation requirement in this ETS is entitled to
deference under Chevron USA, Inc. v. NRDC, 467 U.S. 837 (1984). See
Mourning v. Family Publication Serv., Inc., 411 U.S. 356, 369 (1973)
(upholding agency's authority to promulgate regulations ``reasonably
related to the purposes of the enabling legislation''); Pub. Citizen
Health Rsch. Grp. v. U.S. Dep't of Lab., 557 F.3d 165, 178 (3d Cir.
2009), as amended (May 15, 2009) (affording Chevron deference to OSHA's
``choice of methodology to implement the [OSH Act]'').
The anti-retaliation provision of this ETS is necessary to protect
employees from the grave danger posed by COVID-19 because it is
critically important for employees to be aware of, and to be able to
exercise, their rights under the standard given that employee
participation is essential to mitigating the spread of COVID-19 in the
workplace. For example, employees who are COVID-19-positive must be
able to notify their employer of their condition without fear of
retaliation in order to protect others in the workplace; if an employee
refrains from reporting their condition to the employer due to fear of
retaliation, the employee would not be removed from the workplace and
could spread the infection to other employees. Similarly, employees
must be able to notify their employer of other COVID-19 hazards in the
workplace--such as co-workers refusing to wear PPE or wearing it
improperly--without fear of retaliation; if an employee does not report
a hazardous condition due to fear of retaliation, the employer may not
become aware of the hazard and would not be able to address it. A
workplace free from the threat of retaliation promotes collaboration
between employers and employees in the effort to minimize the risk of
transmission of COVID-19.
OSHA publicly tracks complaints alleging retaliation. The agency's
website shows that, as of May 30, 2021, 5,389 complaints of retaliation
related to workplace protections from COVID-19 had been received (OSHA,
June 1, 2021). Over 800 of these complaints were from the healthcare
industry. During the pandemic, OSHA has received an increased number of
complaints from workers alleging retaliation generally (i.e., not just
related to COVID-19), which OSHA attributes primarily to COVID-19-
related incidents. OSHA received a total of 13,648 retaliation
complaints from April 1, 2020 to April 30, 2021 (including COVID-19-
related complaints), compared to 10,973 total complaints during the
same timeframe in 2019-20, and 10,037 total complaints during the same
timeframe in 2018-19. Approximately 37 percent of the docketed COVID-
19-related complaints OSHA has completed investigating have resulted in
merit findings or settlements involving positive outcomes for
complainants.
Retaliation takes many forms; it occurs when an employer (through a
manager, supervisor, or administrator) fires an employee or takes any
other type of adverse action against an employee for engaging in
protected activity. Adverse actions include discipline; reducing pay or
hours; reassignment to a less desirable position; denying overtime or
promotion; intimidation or harassment; and any other action that would
dissuade a reasonable employee from raising a concern about a possible
violation or engaging in other protected activity. See Burlington
Northern & Santa Fe Railway Co. v. White, 548 U.S. 53, 57 (2006)
(holding, in the Title VII context, that the test for determining
whether a particular action is materially adverse is whether it ``could
well dissuade'' a reasonable person from engaging in protected
activity).
Although the ETS does not change the substantive obligations of
employers to refrain from retaliating against employees for engaging in
protected activity under section 11(c), the anti-retaliation provision
in the ETS serves two additional purposes. First, it increases
awareness of the protections provided to employees. Second, it provides
OSHA with an enhanced enforcement tool for ensuring that employees are
protected from retaliation for exercising their right to the
protections required by the ETS, and for engaging in actions required
by the ETS. In other words, the anti-retaliation provision of the
standard serves a preventive purpose as well as a remedial one. ``The
breadth of agency discretion is, if anything, at zenith when the action
assailed relates primarily not to the issue of ascertaining whether
conduct violates the statute, or regulations, but rather to the
fashioning of policies, remedies and sanctions, . . . in order to
arrive at maximum effectuation of Congressional objectives.'' United
Steelworkers, 647 F.2d at 1230 n.64 (citation omitted).
Regarding the standard's preventive purposes, the requirement for
employers to inform each employee of their rights under the standard
and the prohibition on retaliation serves to educate employees who
might not otherwise be aware of their rights. The explicit prohibition
on retaliation reminds employers of their obligation not to discharge
or discriminate against employees for exercising their right to the
protections required by the ETS, or for engaging in actions required by
the ETS. The standard thus serves to enhance protections against
retaliation by increasing awareness of those protections among both
employees and employers. By increasing awareness, OSHA believes that
the provision will prevent acts of retaliation from occurring in the
workplace and encourage employees to exercise their right to the
protections required by the ETS, to engage in actions required by the
ETS, and to communicate their COVID-19 status to the employer to
mitigate the spread of COVID-19 in the workplace.
Employers have flexibility regarding how they will inform employees
of their rights and the prohibition on retaliation. This information
can be provided along with other training required under the standard,
or it can be provided separately. Employees can be informed
in writing, verbally during a staff meeting, or using other methods.
Employers are able to choose any method of informing employees, so long
as each employee is apprised of the information specified in the
standard.
Regarding the standard's remedial purposes, the prohibition on
retaliation in the standard provides OSHA with a means of addressing
workplace retaliation that is vitally important for protecting
employees from the grave danger presented by COVID-19 in the workplace.
Under section 11(c), an employee who believes they have been retaliated
against may file a complaint with OSHA, and if, after investigation,
the Secretary has reasonable cause to believe that section 11(c) has
been violated, then the Secretary may file a complaint against the
employer in U.S. District Court seeking ``all appropriate relief,''
including reinstatement and back pay (29 U.S.C. 660(c)(2)). However,
section 11(c) only authorizes the Secretary to take action against an
employer for retaliating against an employee if the employee files a
complaint with OSHA within 30 days of the retaliation (29 U.S.C.
660(c)). The ETS provides OSHA with an additional enforcement tool for
promoting employee engagement in mitigating the spread of COVID-19 in
the workplace, which is critical given the grave and unusual danger
COVID-19 poses to workers. Some employees may not have the time or
knowledge necessary to file a section 11(c) complaint or may fear
additional retaliation from their employer if they file a complaint.
The standard allows OSHA to issue citations to employers for
retaliating against employees, and require abatement including back pay
and reinstatement, even if no employee has filed a section 11(c)
complaint within 30 days of the retaliation. OSHA has six months from
the occurrence of a violation to issue a citation under the standard
(29 U.S.C. 658(c)).
In addition, OSHA can address retaliation directly and relatively
quickly by issuing a citation, whereas litigation in U.S. District
Court under section 11(c) is a much slower process. Moreover, OSHA can
issue a single citation addressing retaliation against multiple
employees--for example, if OSHA discovers during an inspection that the
employer terminated multiple employees who tested positive for COVID-
19, or multiple employees who wore their own N95 respirators--without
identifying which employee(s), if any, filed a complaint with OSHA. In
contrast, complaints under section 11(c) must identify each individual
complainant. With cases related to COVID-19, it is critically important
for OSHA to be able to act as quickly and efficiently as possible to
ensure that employees are provided the protections required by the
standard, and are taking the precautions required to protect each other
from COVID-19, without fear of retaliation. Any delay in addressing
retaliation in these circumstances could result in additional cases of
COVID-19 in the workplace, for example if employees hide their COVID-19
status or refrain from taking precautions required to protect
themselves and other employees from COVID-19 because they fear
retaliation from the employer.
The standard does not abrogate or interfere with the rights or
restrictions contained in section 11(c) of the OSH Act. An employee who
wishes to file a complaint under section 11(c) may do so within the
statutory 30-day period regardless of whether OSHA is investigating an
alleged violation of the standard involving the same underlying
conduct. Where OSHA's investigation substantiates the violation, OSHA
will determine (in consultation with the complainant, where
appropriate) whether to pursue a remedy under section 11(c) or through
a citation under the ETS, but not both. A note to paragraph (o) is
included in the regulatory text to provide an additional reminder of
the protections from retaliation provided under section 11(c).
References
Occupational Safety and Health Administration (OSHA). (2021, June
1). COVID-19 Response Summary: Summary Data for Federal Programs--
Whistleblower Data. https://www.whistleblowers.gov/covid-19-data.
(OSHA, June 1, 2021).
O. Requirements Implemented at No Cost to Employees
Paragraph (p) specifies that the implementation of all requirements
of the standard, with the exception of any employee self-monitoring
conducted under paragraph (l)(1)(i), must be at no cost to employees.
This provision is included to make it clear that the employer is
responsible for costs associated with implementation of the standard.
The requirement is consistent with the OSH Act, which requires
employers to ensure a safe and healthful work environment. It is also
consistent with OSHA's past practice in numerous rulemakings. In
indicating that the implementation of all requirements of this standard
must be at no cost to the employee, OSHA considers costs to include not
only direct monetary expenses to the employee, but also the time and
other expenses necessary to perform required tasks.
It is vitally important that the protections of the ETS are
provided at no cost to employees. For example, OSHA concluded in the
agency's final rule on Employer Payment for Personal Protective
Equipment (PPE) that requiring employers to pay for PPE results in
significant safety benefits because employees are more inclined to use
PPE if it is provided to them at no cost (72 FR 64341, 64344). As
described in Need for Specific Provisions (Section V of this preamble),
facemasks, face shields, respirators, and other PPE are critical to
minimizing the risk of COVID-19 transmission in the workplace. Employer
payment for these items therefore serves to enhance the protection of
employees from COVID-19 hazards. Similarly, employees are more likely
to take advantage of other workplace protections if they are provided
at no cost. For example, in one instance where employees were
transported to and from a hospital at company expense for a work-
related medical exam, and they received their normal pay during
transportation, waiting, and examination time, employee participation
was 100%. When subsequent examinations were scheduled outside working
hours and employees were not provided with transportation or
compensated for their time, participation dropped to 58%. See Phelps
Dodge Corp. v. OSHRC, 725 F.2d 1237, 1238 (9th Cir. 1984).
The requirement that protections under the standard be provided at
no cost to employees applies broadly to the provisions of the standard.
For example, paragraph (f) includes requirements for facemasks, face
shields, and in some circumstances, respirators and other PPE.\138\
These items must be provided at no cost to employees. Paragraph
(f)(1)(iv) provides an exception to this requirement for employees who
provide their own face shields. When the employer allows employees to
use their own face shields, the employer is not required to reimburse
the employees for the cost of those face shields.
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\138\ This Summary and Explanation of paragraph (p) highlights
some of the requirements that must be implemented at no cost to
employees. This discussion is intended to be illustrative of the
requirement that, with limited exceptions, employees are not to bear
the costs of implementing the standard; it is not intended to be an
exclusive list of the standard's no cost requirements. As stated in
paragraph (p), the implementation of all requirements of the
standard, with the exception of any employee self-monitoring
conducted under paragraph (l)(1)(i), must be at no cost to
employees.
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In addition, paragraph (f)(4)(ii) requires the employer to permit
an employee to wear their own respirator
instead of a required facemask. In this circumstance, when an employee
provides and uses their own respirator, the employer is not obligated
to pay the employee for the cost of procuring or maintaining the
respirator. OSHA believes it is reasonable for the employee to assume
responsibility for the cost of the respirator in this circumstance
because the employee is choosing to wear PPE that is more protective
than what is required under the standard. The employer must provide the
protections required by the standard at no cost to employees, but is
not obligated to pay for protections beyond those required, or for
alternatives chosen by the employee.
Paragraph (l)(1)(i) requires the employer to screen each employee
before each work day and each shift. The provision allows for employee
self-monitoring as well as screening in-person by the employer. Where
employers elect to conduct screening by having employees self-monitor
before reporting to work, the standard does not require them to
compensate employees for any incidental costs they incur (e.g., the
time needed to respond to a questionnaire).
Paragraph (l)(1)(ii) explicitly indicates that any COVID-19 test
required by the employer for screening purposes must be provided at no
cost to the employee. If a test is covered and paid for by an
employee's employer-provided health insurance, and the employee does
not incur any other expenses (e.g., leave time), the test has been
provided at no cost to the employee. Similarly, any COVID-19 test
provided under paragraph (l)(4)(ii)(B) must be provided free of cost to
the employee. If testing under either of these provisions requires
travel by the employee, the employer is required to bear the cost of
travel (e.g., mileage for personal vehicle use, public transportation
fare), and the employee must be paid at their regular rate of pay for
time spent receiving the test, including travel time.
Paragraph (m) requires that employers support COVID-19 vaccination
through reasonable time and paid leave for its employees. Paragraph (m)
requires employers to cover the time off needed for full vaccination
and for recovery from vaccine side effects, through provision of paid
leave to all employees who decide to get vaccinated, resulting in the
requirements of the standard being provided at no cost to employees
(transportation costs are not required to be covered by employers).
Paragraph (n) requires the employer to ensure that each employee
receives training, in a language and at a literacy level the employee
understands, so that the employee comprehends specified elements
regarding COVID-19, associated hazards in the workplace, the measures
in place to protect employees from those hazards, and other specified
topics. Employers must provide this training, including reasonable
accommodation as required by the Americans with Disabilities Act if
needed by an employee with a disability, at no cost to the employee.
The employee must be paid for time spent receiving training. If an
employee must travel away from the workplace to receive training, the
employer is required to bear the cost of travel, and the employee must
be paid for travel time. Any training or other communications provided
under paragraph (o)(1), which requires employers to inform each of
their employees about certain anti-retaliation-related topics, must
similarly be provided at no cost to employees.
P. Recordkeeping
Section 8(c)(1) of the Act requires employers to ``make, keep and
preserve, and make available to the Secretary [of Labor] or the
Secretary of Health and Human Services, such records regarding his
activities relating to this Act as the Secretary, in cooperation with
the Secretary of Health and Human Services, may prescribe by regulation
as necessary or appropriate for the enforcement of this Act or for
developing information regarding the causes and prevention of
occupational accidents and illnesses.'' Section 8(c)(2) of the Act
specifically directs the Secretary of Labor to promulgate regulations
requiring employers to maintain accurate records of work-related
injuries and illnesses. Section 8(c)(3) of the Act requires employers
to ``maintain accurate records of employee exposures to potentially
toxic materials or harmful physical agents which are required to be
monitored or measured under section 6 [of the Act.]'' In accordance
with section 8(c), and after consultation with HHS, OSHA has included
recordkeeping requirements in paragraph (q). This paragraph includes
requirements for the creation, maintenance, and availability of certain
COVID-19-related records, including the retention of the COVID-19 plan
required by paragraph (c), the establishment and maintenance of a
COVID-19 log, as well as the availability of records to employees,
employee representatives, and OSHA.
Although the Act provides OSHA with authority to require all
employers covered by OSHA to keep records, one major class of employers
is not required to keep records under paragraph (q). Paragraph (q)(1)
provides that small employers with 10 or fewer employees on the
effective date of this section are not required to comply with the
recordkeeping provisions in paragraph (q)(2) or (q)(3). The approach to
the scope in this section is generally consistent with the partial
exemption in 29 CFR 1904.1, which provides that an employer in any
industry with 10 or fewer employees at all times during the last
calendar year is not required to maintain OSHA records of occupational
injuries and illnesses during the current year unless required to do so
in writing by OSHA.
The size exemption in paragraph (q)(1) is based on the total number
of employees in a firm, rather than the number of employees at a
particular location or establishment. An exemption based on individual
establishments would be difficult to administer, especially in cases
where an individual employee, such as a physician or nurse, regularly
reports to work at several establishments. Under the 10-or-fewer
employee exception in this paragraph, OSHA expects, based on the
agency's analysis of healthcare employers as part of its economic
analysis, that approximately 70% of healthcare employers potentially
covered by this ETS would not be required to maintain records required
under paragraph (q)(2) or make such records available under paragraph
(q)(3) of this section.
All individuals who are ``employees'' under the OSH Act are counted
in the total; the count includes all full-time, part-time, temporary,
and seasonal employees. For businesses that are sole proprietorships or
partnerships, the owners and partners would not be considered employees
and would not be counted. Another example of individuals who are not
considered to be employees under the OSH Act are unpaid volunteers (see
66 FR 5916, 6038).
Additionally, OSHA's regulation at 29 CFR 1904.2 partially exempts
certain lower-hazard industry groups from the requirement for keeping
occupational injury and illness records. However, the partial exemption
in 29 CFR 1904.2 does not apply to the recordkeeping requirements in
paragraph (q) of this section. All covered employers, even those that
are partially-exempt under OSHA's recordkeeping regulation, must comply
with the recordkeeping requirements in this paragraph if they have more
than 10 employees on the effective date of this section. Also, although
exempted from maintaining records under paragraph (q) of this section,
employers with 10 or fewer
employees are required to report to OSHA each work-related COVID-19
fatality and in-patient hospitalization as required by paragraph (r) of
this section.
Paragraph (c)(6) requires employers to monitor each workplace to
ensure the ongoing effectiveness of the COVID-19 plan and update it as
needed. Employers may also revise an original plan and implement an
updated plan due to the evolving nature of the COVID public health
emergency. Paragraph (q)(2)(i) requires covered employers to retain all
versions of the COVID-19 plans implemented to comply with this ETS
while the ETS remains in effect. As discussed in more detail below, the
retention of the finalized, implemented COVID-19 plans (not drafts)
will aid employers, employees, and employee representatives in several
ways, including assisting with the evaluation of the efficacy of
policies and procedures employers have taken iteratively in response to
changing circumstances. As discussed above, paragraph (c) requires
employers with more than 10 employees to develop, implement, and update
a written COVID-19 plan for each workplace. Since paragraph (c)
requires employers to update their written COVID-19 plan as needed,
paragraph (q)(2)(i) requires employers to retain all versions of the
plan while this ETS is in effect.
One of the main purposes for the retention requirement is to
provide employees, former employees, and their representatives with
access to the written plan. As discussed below, paragraph (q)(3)(i)
requires employers to provide access to employees and employee
representatives to all versions of the written COVID-19 plan.\139\ OSHA
believes that access to the plan will not only inform employees about
the contents of the document, but will also lead to increased employee
involvement in the development and updating of the plan. In addition,
OSHA believes retention of all versions of the plan will ultimately
assist employers in the prevention of COVID-19 exposure in their
workplaces. Retention of all versions of the plan will enable employers
to better evaluate the effectiveness of policies and procedures they
have taken to limit exposure to COVID-19 and will ensure that employees
and their representatives can provide meaningful contributions to the
review and improvement of the COVID-19 plan. Additionally, making all
versions of the plan available to OSHA (as required by paragraph
(q)(3)(iv)) will allow the agency to verify the effectiveness of
employee protections.
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\139\ Consistent with 29 CFR part 1904.35(a)(3), OSHA interprets
the term ``employee'' as used in paragraph (q)(3)(i)-(iii) to
include former employees. In accordance with this interpretation,
OSHA also interprets the phrases ``their personal representatives''
and ``their authorized representatives,'' as used in paragraph
(q)(3)(i) and (q)(3)(iii), to include the personal and authorized
representatives of former employees. These interpretations are
limited to these provisions. Note, as discussed in more detail
below, that for former employees and their representatives, the
requirement to provide access to the written COVID-19 plan under
paragraph (q)(3)(i) is limited to the versions of the plan that were
implemented during the former employees' employment.
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Under paragraph (q)(2)(ii), employers with more than 10 employees
on the effective date of this section are required to establish and
maintain a COVID-19 log and record each instance identified by the
employer in which an employee is ``COVID-19-positive,'' meaning that
person has a confirmed positive test for, or has been diagnosed by a
licensed healthcare provider with, COVID-19, regardless of whether the
instance is connected to exposure to COVID-19 at work. However, the
COVID-19 log should not record incidences for employees who work
exclusively from home and thus could not expose others in the
workplace. As explained in a Note to paragraph (q)(2)(ii), the COVID-19
log is intended to assist employers with tracking and evaluating
instances of employees who are COVID-19-positive without regard to
whether those employees were infected at work. While the workplace is
immediately impacted by having a COVID-19-positive employee because of
the potential exposure to others, it can often be difficult to
determine quickly whether that employee was infected at work or
elsewhere, so OSHA has relieved employers of the burden of trying to
make that determination for the COVID-19 log. Because of the need to
quickly identify and track potential workplace exposure trends and
inform others in the workplace about potential exposures, as well as
implement other requirements of the standard (i.e., medical removal
from the workplace), it is more urgent to record an instance where an
employee is COVID-19-positive and the details surrounding that instance
than to wait to determine whether the instance was work-related. OSHA
believes that the requirement to establish and maintain a COVID-19 log
will ultimately assist employers in preventing workplace transmission,
even when cases arise that do not originate in the work environment.
Paragraph (q)(2)(ii)(A) provides that the COVID-19 log must
contain, for each instance, the employee's name, one form of contact
information (e.g., phone number or email address), occupation, location
where the employee worked, the date of the employee's last day at the
workplace, the date of the positive test for, or diagnosis of, COVID-
19, and the date the employee first had one or more COVID-19 symptoms,
if any were experienced. When making entries on the COVID-19 log,
employers should only enter the specific information required to be
entered. The recording of additional information (not required to be
entered) may result in privacy concerns for the employee who is the
subject of the entry.
The main purpose of the COVID-19 log is to assist employers in
tracking whether there is a COVID-19 outbreak at the worksite.
Information about specific occupations and locations where employees
have worked can be used to pinpoint where exposure has occurred. For
example, if the occupation of the infected employee is ``healthcare
assistant'', the location is ``floors 3 through 5'', and those floors
consist mainly of patient examination and hospital rooms, the employer
may be able to conclude that the employee had spent time working with
other health care providers in rooms on those floors and may be able to
determine what times exposures in each place would have occurred based
on other patient and provider records.
Also, entering information on the COVID-19 log about an employee
with non-work-related COVID-19 illness assists an employer in tracking
how and when the disease entered the workplace. By entering information
about all employee cases of COVID-19, the time needed by employers to
make work-relatedness determinations is eliminated, and thus results in
information being entered on the COVID-19 log in a timely manner. In
addition, the information entered on the log may assist an employer in
determining whether the employer's policies and procedures have been
effective in the prevention of COVID-19 in their workplace.
Additionally, paragraph (q)(2)(ii)(B) requires employers to make
entries on the COVID-19 log within 24 hours of learning that an
employee is COVID-19-positive. The 24-hour timeframe ensures that
information about an employee's confirmed or diagnosed illness is
timely entered on the COVID-19 log. At some worksites, timely
information entered on the COVID-19 log may assist employees and their
representatives, who have a right of access to certain information on
the log, in preventing the spread of the disease throughout a facility.
Specifically, the timely entry of COVID-19 illness information on the
log may assist employee representatives in identifying exposure trends
in different areas of a workplace.
The COVID-19 log required by the ETS differs from the OSHA 300 log
that employers are required to maintain under the OSHA injury and
illness recordkeeping regulation at 29 CFR part 1904. Most importantly,
under 29 CFR part 1904, employers are required to make several
determinations regarding the recordability of specific injuries and
illnesses before information is entered on the 300 log. For example,
employers are not required to record non-work-related illnesses and
injuries on their OSHA 300 logs. Therefore, in order to determine
whether to record COVID-19 illness on the OSHA 300 log, employers must
determine whether the illness is work-related. Under paragraph
(q)(2)(ii), employers are required to enter information on the COVID-19
log regardless of whether an employee's illness is the result of a
work-related exposure. Also, under 29 CFR part 1904, employers must
generally provide access to the 300 log to employees, former employees,
and their representatives with the names of injured or ill employees
included on the form. By contrast, employers must maintain the COVID-19
log as though it is a confidential medical record and must not disclose
it except when providing access as required by paragraph (q)(3), or
other federal law. As a result, while some COVID-19 illnesses may
qualify for entry on both logs, the OSHA 300 log may not be used as a
substitute for the COVID-19 log required by this section.
Finally, as explained in a Note to paragraph (q), employers must
continue to record all work-related confirmed cases of COVID-19 on
their OSHA Forms 300, 300A, and 301, or on equivalent forms, if
required to do so under 29 CFR part 1904. The recordkeeping regulation
at 29 CFR part 1904 includes additional requirements for the recording
of work-related COVID-19 illness from this ETS. Under 29 CFR part 1904,
COVID-19 is a recordable illness and employers are responsible for
recording cases of COVID-19 if: (1) The case is a confirmed case of
COVID-19 as defined by the Centers for Disease Control and Prevention
(CDC); (2) the case is work-related as defined by 29 CFR 1904.5; and
(3) the case involves one or more of the general recording criteria in
set forth in 29 CFR 1904.7 (e.g., medical treatment beyond first aid,
days away from work).
Paragraph (q)(2)(ii)(B) also requires that the information in the
COVID-19 log be maintained as though it is a confidential medical
record and must not be disclosed except as required by this ETS or
other federal law. OSHA historically has recognized that occupational
safety and health records maintained by employers may contain
information of a sufficiently intimate and personal nature that a
reasonable person would wish to remain confidential. While the entries
of information on the COVID-19 log may be brief, they may contain
information that could result in a serious confidentiality or privacy
concern if disclosed to other employees, former employees, or their
representatives. Accordingly, under this section, the disclosure of
personal information entered on the COVID-19 log is limited to the
access provisions set forth in paragraph (q)(3), or as required by
other federal laws. Otherwise, employers must maintain the log as
though it is a confidential medical record.\140\
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\140\ Please note that the employer is still required to enter
work-related COVID-19 cases on the 300 log pursuant to 29 CFR part
1904 and must provide access to them under 29 CFR part
1904.35(b)(2)(iv). However, employees do have the right to ask
employers to record their injury or illness on the 300 log as a
``privacy concern case.'' In such a case, employers do not enter the
employee's name on the 300 log. Instead, the employer enters
``privacy case'' in the space normally used for the employee's name.
Per 29 CFR part 1904.29(b)(6), the employer would then keep a
separate, confidential list of the case numbers and employee names
for their privacy concern cases so they can update the cases and
provide the information to the government if asked to do so (see 29
CFR part 1904.29(b)(6)-(9)). Also, 29 CFR part 1904.29(b)(9)
provides that, even after the employee's name has been removed, if
an employer has a reasonable basis to believe that the information
describing a privacy concern case may identify the employee, the
employer may use discretion in describing the case on the OSHA
recordkeeping forms to protect the identity of the employee while
still accomplishing the purpose of keeping the record.
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One of the major federal regulations addressing the privacy of
individuals' health information is the U.S. Department of Health and
Human Services (HHS) regulations at 45 CFR parts 160 and 164, known as
the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
``Privacy Rule.'' The Privacy Rule protects the privacy of individually
identifiable health information (referred to as ``protected health
information'' or ``PHI'') maintained or transmitted by HIPAA-covered
entities \141\ and their business associates. The Privacy Rule is also
balanced to ensure that appropriate uses and disclosures of PHI can be
made when necessary to treat a patient, to protect the nation's public
health, and for other important purposes. A covered entity may not use
or disclose PHI except as permitted or required by the Privacy Rule
(see 45 CFR part 164.502).
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\141\ ``Covered entities'' are health plans, health care
clearinghouses, and health care providers who conduct certain
standard transactions electronically (see 45 CFR 160.103).
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The term ``covered entity'' includes health plans, health care
clearing houses, and health care providers who transmit health
information in electronic form. For OSHA purposes, this mainly refers
to a health care provider, defined in the Privacy Rule as any person or
organization that furnishes, bills, or is paid for health care in the
normal course of business.
The HIPAA Privacy Rule excludes certain individually identifiable
health information from the definition of PHI. For example, employment
records held by a covered entity in its role as an employer are not PHI
and the HIPAA Privacy Rule would not affect the disclosure of health
information contained in employment records to OSHA (see 45 CFR part
160.103).
With respect to disclosures of PHI made by covered entities
directly to OSHA, the agency notes that the Privacy Rule specifically
permits disclosures of PHI without an individual's authorization for
certain purposes. Of particular significance is 45 CFR part 164.512,
``Uses and disclosures for which an authorization or opportunity to
agree or object is not required.'' These standards do not compel a
covered entity to disclose PHI. Instead, they permit the covered entity
to make the requested disclosure without obtaining authorization from
the individuals who are the subjects of the PHI. Section 164.512(a) of
the Privacy Rule permits covered entities to use and disclose PHI,
without an individual's authorization, when they are required to do so
by another law. HHS has made clear that this provision encompasses an
array of binding legal authorities, including statutes, agency orders,
regulations, or other federal, state, or local governmental actions
having the effect of law (see 65 FR 82668). As a result, the Privacy
Rule, in and of itself, generally does not provide a justification for
a covered entity to refuse to disclose PHI to OSHA as required by an
OSHA standard or regulation. Based on its finding that the ETS is
necessary to address the grave danger that the SARS-CoV-2 virus
presents to workers, OSHA further finds that the COVID-19 log is
critical to convey the specified information in a timely manner that is
critical for worker protection.
A covered entity may also disclose PHI without an individual's
authorization to ``public health authorities'' and to ``health
oversight agencies'' (see 45 CFR parts 164.512(b) and (d)). The
preamble to the Privacy Rule issued in 2000 specifically mentions OSHA
as an example of both
(see 65 FR 82492, 82526). Accordingly, while employers must maintain
the COVID-19 log in a manner consistent with federal and state privacy
requirements, they generally may not refuse to disclose PHI when
required or requested by OSHA based solely on the provisions of the
Privacy Rule. Also, because paragraph (q)(3) of this ETS includes a
specific, legally enforceable right of access, the Privacy Rule permits
employers to disclose certain PHI to employees, former employees, and
their representatives, to the extent the disclosure is ``required by
law'' (and must do so as required by the ETS).
Paragraph (q)(2)(ii)(C) provides that the COVID-19 log must be
maintained and preserved while this section remains in effect. The
purpose of this retention requirement is twofold. First, retention of
the log allows employers to review previously entered information over
a long period of time. This can be useful to determine which policies
and procedures at a workplace have been effective in reducing
occupational exposure to COVID-19. Second, retention of the log allows
for access of the entered information by employees, former employees,
and their representatives, and OSHA, which can facilitate tracing of
potential exposures at a particular worksite and at other worksites
where infected employees may have traveled.
The maintenance requirement in paragraph (q)(2)(ii)(C) does not
specify a particular method by which employers must maintain the log.
Employers have flexibility in choosing a method for maintaining the
information on the log. In making these decisions, employers should
consider using a method that gives them the ability to effectively
enter, update, and retain the information on the log while this section
remains in effect, and ensures that the entered information is both
accurate and secured. Also, employers should use a method that can
allow for transmission of data when employees, former employees, and
their representatives, and OSHA, request access to information under
paragraph (q)(3), especially when information is maintained at a
centralized location.
For purposes of centralized recordkeeping, the COVID-19 log may be
maintained at a location other than the establishment, such as a
company's central office. Employers with several distinct
establishments or workplaces may keep several versions of the log at a
centralized location. However, if the COVID-19 log(s) is maintained at
a central location, the employer must ensure that the information on
the log can be accessed by employees, employee representatives, and
OSHA at the relevant worksite in accordance with the requirements of
the ETS.
Finally, if a business changes ownership while the ETS is in
effect, the selling employer is responsible for transferring
information on the COVID-19 log to the new owner. Under these
circumstances, the previous owner is responsible for transferring all
of the information entered on the COVID-19 log to the new owner, and
the new employer becomes responsible for retaining that COVID-19 log.
This will help ensure that the new employer is aware of previously
entered COVID-19 exposure information, and that employees and their
representatives who remain after the sale, as well as former employees
and their representatives, will have continued access to all of the
COVID-19 log information at their workplace or former workplace.
Paragraph (q)(3) includes requirements for the access, upon
request, by employees, former employees, and their representatives to
records retained or maintained by employers under paragraph (q). In
addition, paragraph (q)(3) includes requirements for records access for
the Assistant Secretary. One of the goals of the access requirements is
to enhance employee involvement in the process for preventing COVID-19
exposure in the workplace. OSHA believes employee access to information
about COVID-19 is an essential part of an effective COVID-19 plan. When
employees do not have access to accurate information about hazards they
face in their workplace, the likelihood increases that employees may
suffer occupational injuries and illnesses. This would mean, for
purposes of COVID-19, that employers and employees would not have
information they need to prevent the outbreak and spread of the virus
in their workplace.
Paragraph (q)(3) specifies that the employer must provide the
records specified in paragraph (q)(3)(i)-(iv) to the specified
individuals for examination and copying by the end of the next business
day after a request. By requiring prompt production of these records,
the provision ensures that requesters, who are limited to employees and
their representatives, can have the information necessary to take an
active role in their employers' efforts to prevent COVID-19 exposure in
the workplace.
Paragraph (q)(3)(i)-(iv) provides more details about which records
the employers must provide access to and to whom that access must be
provided. Paragraph (q)(3)(i)-(iii) focuses on records access for
employees and their representatives. As noted above, and consistent
with 29 CFR 1904.35(a)(3), OSHA interprets the term ``employee'' as
used in paragraph (q)(3)(i)-(iii) to include former employees. In
accordance with this interpretation, OSHA also interprets the phrases
``their personal representatives'' and ``their authorized
representatives,'' as used in paragraphs (q)(3)(i) and (iii), to
include the personal and authorized representatives of former
employees. These interpretations are limited to these provisions.
In addition, for purposes of paragraph (q)(3), the term
``representative'' is intended to have the same meanings as in 29 CFR
1904.35(b)(2), which encompasses two types of employee representatives.
The first is a personal representative of the employee or former
employee, who is a person the employee or former employee designates,
in writing, as his or her personal representative, or is a legal
representative of a diseased or legally incapacitated employee or
former employee. The second is an authorized representative, which is
defined as an authorized collective bargaining agent of one or more
employees working at the employer's worksite. Authorized
representatives do not require separate written authorization to access
the version of the COVID-19 log described in paragraph (q)(3)(iii)
because they have received broad authorization (see below for more
details regarding this version of the log).
Under paragraph (q)(3)(i)-(iii), employees, former employees, and
their representatives have three specific access rights. First,
pursuant to paragraph (q)(3)(i), employees and their representatives
have access to all versions of the written COVID-19 plan at any
workplace where the employee or former employee has worked. Second,
pursuant to paragraph (q)(3)(ii), any employee, former employee, and
anyone having written consent of that employee or former employee have
access to the COVID-19 log entry for that employee or former employee.
Finally, under paragraph (q)(3)(iii), employees, former employees, and
their representatives have a right to access a version of the COVID-19
log that removes the names of employees, contact information, and
occupation, and only includes, for each employee in the COVID-19 log,
the location where the employee worked,\142\
the last day that the employee was at the workplace before removal, the
date of that employee's positive test for, or diagnosis of, COVID-19,
and the date the employee first had one or more COVID-19 symptoms, if
any were experienced. As noted above, the employer must provide these
records to these individuals upon request for examination and copying
not later than by the end of the next business day after the request.
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\142\ The employer should use discretion when possible. This
location should be specific enough to accomplish the purpose of this
recordkeeping in alerting people where the COVID-19 hazard was
located, but avoid the level of specificity that might reveal the
employee's identity unnecessarily. In some cases, such as when only
a single employee works in a location, it will be infeasible to
avoid alerting others to the employee's identity. But in other
cases, instead of saying that employee worked at a particular piece
of equipment or in a particular portion of a room, the employer
could just identify the room where the employee was.
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Employee, and employee representative, access to this information
is critical to ensuring full employee participation in employer efforts
to prevent COVID-19 exposure in the workplace. For example, access to
the COVID-19 log may be helpful for a requesting employee in
determining the likelihood of COVID-19 exposure in specific occupations
or areas at a workplace. Also, access to information by employee
representatives allows them to potentially evaluate exposure
information for the employees they represent in different areas
throughout a worksite. In addition, access to the information on the
COVID-19 log provides a useful check on the accuracy of information
entered by the employer and provides greater employee involvement in
the COVID-19 protection program at the workplace.
Former employee access to these records is important as well. OSHA
finds that the needs of former employees for access to records that
could speak to their health are as compelling as the needs of current
employees. Therefore, as noted above, OSHA interprets the term
``employee'' as used in paragraph (q)(3)(i)-(iii) to provide records
access to former employees and their representatives. Employers should
note, however, that they may limit the access of a former employee and
their representatives to versions of the written COVID-19 plan and the
COVID-19 log that were current or otherwise relevant to the former
employee's time of employment. In other words, as to the requirement in
paragraph (q)(3)(i) to provide all versions of the written COVID-19
plan to former employees and their representatives, employers need only
provide the versions of the plan that were implemented during the
former employees' employment. Similarly, as to the requirement in
paragraph (q)(3)(iii) to provide the version of the COVID-19 log that
removes the names of employees, contact information, and occupation,
and only includes, for each employee in the COVID-19 log, the location
where the employee worked, the last day that the employee was at the
workplace before removal, the date of that employee's positive test
for, or diagnosis of, COVID-19, and the date the employee first had one
or more COVID-19 symptoms, if any were experienced, to former employees
and their representatives, employers are only required to provide log
entries for dates on which the former employee was employed by the
employer.
Employers should note that employee privacy is protected under the
access to records provisions in paragraph (q)(3). Unlike the OSHA 300
log, employers are not permitted to disclose the names of employees or
occupations entered on the COVID-19 log when they provide the COVID-19
log to employees, former employees, or their representatives for
copying under paragraph (q)(3)(iii). However, paragraph (q)(3)(ii) does
allow a limited exception to this privacy requirement. Specifically, as
noted above, upon request, employers must provide access to the COVID-
19 log entry for an individual employee or former employee to that
employee or former employee, or to anyone having that employee or
former employee's written permission. Consequently, employees, former
employees, their representatives, and others can request and receive
access to entries about another employee or former employee with that
employee or former employee's written permission.
In order to create the version of the COVID-19 log that would be
provided under paragraph (q)(3)(iii), an employer must remove the
names, contact information, and occupation of employees. Other
information on the COVID-19 log relating to the location where the
employee worked, the last day the employee was at the workplace before
removal, the date of the employee's positive test for, or diagnosis of,
COVID-19, and the date the employee first had COVID-19 symptoms, if any
were experienced, must be included in the privacy-protected log. This
information is critical for employees and their representatives to
assess potential exposures to COVID-19 in the workplace and is the only
information that may be included on the version of the log provided to
employees and representatives under paragraph (q)(3)(iii). Without the
provision of this information to employees and their representatives,
the only potential check on whether the employer is accurately
complying with the notification requirements of the ETS would be OSHA
inspections. The agency believes that making this information available
to employee representatives in a manner that still addresses privacy
concerns will help ensure compliance with the requirements of the ETS
and thereby protect workers.
In addition, as noted above, paragraph (q)(2)(ii)(B) provides that
the information in the COVID-19 log must be maintained as though it is
a confidential medical record and must not be disclosed except as
required by this ETS or other federal law. These provisions work
together to take steps to preserve employee privacy and
confidentiality.
Under the ETS, employees, former employees, and their
representatives are entitled to one free copy of each requested record,
which is consistent with 29 CFR 1904.35. The cost of providing one free
copy to employees, former employees, and/or their representatives is
minimal, and these individuals are more likely to access the records if
it is without cost. Allowing the employer to charge for a copy of the
record would only delay the production of the information. After
receiving an initial, free copy of a requested record or document, an
employee, former employee, or representative may be charged a
reasonable fee for copying duplicative records. However, no fee may be
charged for an update to a previously requested record.
Lastly, paragraph (q)(3)(iv) provides OSHA with a specific right of
access. Under this paragraph, employers must provide OSHA with access
to the records required to be created and maintained by this section.
This means that employers must allow OSHA representatives to examine
and copy all versions of the COVID-19 written plan, as well as all
information entered on the COVID-19 log, when the OSHA representative
asks for the records during a workplace safety and health inspection.
OSHA does not believe that its inspectors need to obtain employee
permission to access and review personally-identifiable information
entered on the COVID-19 log. Gaining this permission would essentially
make it impossible to obtain full access to the log in a timely manner,
which is needed by OSHA to perform a meaningful workplace
investigation. Also, without complete access to the information entered
on the log, Agency efforts to conduct immediate intervention or
remediation of COVID-19 exposure at a specific workplace would be
limited. Finally, OSHA representatives need
access to the names entered on the log in order to interview employees
at the workplace, and to access employee personnel and medical records.
Q. Reporting
OSHA has required employers to report work-related fatalities and
certain work-related hospitalizations under its recordkeeping
regulation since 1971. These requirements have been an important part
of the agency's statutory mission to assure safe and healthful working
conditions for all working men and women. All employers covered by the
OSH Act, including employers who are partially exempt from maintaining
injury and illness records, are required to comply with OSHA reporting
requirements at 29 CFR 1904.39. Under OSHA's current reporting
regulation, employers are required to report each work-related fatality
to OSHA within 8 hours of the event, and each work-related in-patient
hospitalization, amputation, and loss of an eye within 24 hours of the
event.
The purpose of the reporting requirement in Sec. 1904.39 is to
provide OSHA with information to determine whether it is necessary for
the agency to conduct an immediate investigation at a specific
establishment. Employer reports of work-related COVID-19 fatalities and
in-patient hospitalizations are an important element of the agency's
efforts to reduce occupational exposure to the virus. After receiving
an employer report, OSHA decides whether an inspection is needed to
determine the cause of a work-related COVID-19 fatality or in-patient
hospitalization, and whether any OSHA standards may have been violated.
These reports are critical for the agency to respond quickly to COVID-
19 exposure that may pose an ongoing risk to other employees at the
worksite. Timely investigation also allows OSHA to view evidence at a
workplace soon after a work-related COVID-19 fatality or in-patient
hospitalization has occurred, and can make it easier for the agency to
gather relevant information from others at the worksite that might be
useful in protecting other employees. Moreover, prompt inspection
enables OSHA to gather information to evaluate whether its current
standards adequately address the workplace hazard presented from COVID-
19. The information gathered from employer reports is also used by the
agency to form the basis of statistical data on the causes and
remediation of work-related COVID-19 fatalities and in-patient
hospitalizations.
In order to address the unique circumstances presented by COVID-19,
and to facilitate OSHA investigation and better workplace health
surveillance, paragraph (r)(1) requires covered employers to report
each work-related COVID-19 fatality to OSHA within 8 hours of the
employer learning about the fatality, and each work-related COVID-19
in-patient hospitalization to OSHA within 24 hours of the employer
learning about the in-patient hospitalization. As discussed in more
detail in the following discussion, OSHA is adding these additional
COVID-19 reporting requirements because of the delay in the
manifestation and progression of symptoms of COVID-19 can lead to
hospitalization or fatality outside the normal window for reporting
those workplace events.
Paragraph (r)(1)(i) provides that employers must report each work-
related COVID-19 fatality to OSHA within 8 hours of the employer
learning about the fatality. Under this paragraph, an employer must
make a report to OSHA within 8 hours of learning both (1) that an
employee has died from a confirmed case of COVID-19, and (2) that the
cause of death was the result of a work-related exposure to COVID-19.
Employers are only required to report confirmed case of COVID-19 as
defined by the Centers for Disease Control and Prevention (CDC) (CDC,
May 20, 2020). Typically, the cause of death is determined by the
physician who was responsible for a patient who died in a hospital,
although the cause of death can also be determined by others such as
medical examiners or coroners (Pappas, May 19, 2020).
The requirement in paragraph (r)(1)(i) is similar to the fatality
reporting requirement in OSHA's regulation at 29 CFR 1904.39(a)(1),
which requires an employer to report to OSHA within 8 hours after the
death of any employee as the result of a work-related incident.
However, 29 CFR 1904.39(b)(6) requires employers to report a work-
related fatality to OSHA only if the fatality occurs within 30 days of
``the work-related incident.'' Prior to this ETS, for purposes of
reporting events involving COVID-19, OSHA interpreted the phrase ``the
work-related incident'' to mean ``exposure'' in the work environment.
Therefore, in order to be reportable under 29 CFR 1904.39(a)(1), a
work-related fatality due to COVID-19 needed to have occurred within 30
days of an employee's exposure in the work environment. Given the
possibility of long-term illness before death, the 30-day limitation
for reporting fatalities to OSHA could restrict OSHA's ability to
receive information about work-related COVID-19 fatalities.
To address these issues, OSHA has chosen not to apply the 30-day
limitation period from 29 CFR 1904.39(b)(6) to the reporting provision
in paragraph (r) (see paragraph (r)(2). Therefore, the requirement to
report these fatalities is not limited by the length of time between
workplace exposure and death. The reporting of work-related COVID-19
fatalities that occur beyond 30 days from the time of exposure will
enable the agency to evaluate more work-related COVID-19 fatalities to
determine whether immediate investigations are needed to prevent other
employees at the same worksite from being exposed to the virus. Unlike
entries in the employer's COVID-19 log, which would typically only be
viewed by OSHA if an investigation occurs, the report of these
fatalities to OSHA facilitates the agency's timely tracking of this
data. Accordingly, paragraph (r)(1)(i) requires employers to report
each work-related COVID-19 fatality to OSHA within 8 hours of the
employer learning about the fatality regardless of when the exposure in
the work environment occurred.
Paragraph (r)(1)(ii) of the standard requires an employer to report
each work-related COVID-19 in-patient hospitalization to OSHA within 24
hours of the employer learning about the in-patient hospitalization.
Under this paragraph, and similar to OSHA's reporting regulation at 29
CFR 1904.39, an employer must make a report to OSHA within 24 hours of
learning that (1) an employee has been in-patient hospitalized due to a
confirmed case of COVID-19, and (2) the reason for the hospitalization
was the result of a work-related exposure to the illness.
OSHA's current reporting regulation at 29 CFR 1904.39(a)(2)
provides that, within 24 hours after the in-patient hospitalization of
one or more employees, as the result of a work-related incident, an
employer must report the in-patient hospitalization to OSHA. 29 CFR
1904.39(b)(6) requires employers to only report in-patient
hospitalizations to OSHA if the hospitalization occurs within 24 hours
of the work-related incident. For example, if an employee trips in the
workplace and sustains an injury on Monday, but is not hospitalized
until Thursday, the employer does not need to report the event. In this
example, ``the work-related incident'' occurred on Monday when the
employee tripped and was injured in the workplace. Also, under Sec.
1904.39, employers must report in-patient hospitalizations to OSHA
within 24 hours of knowing both that the employee has been in-patient
hospitalized and that the reason for the hospitalization was the result
of ``the work-related incident'' (see 29 CFR 1904.39(a)(2), (b)(7)
and(8)). In non-COVID cases, the work-relatedness of the injury is
typically apparent immediately.
Since the beginning of the pandemic, the reporting of work-related
COVID-19 in-patient hospitalizations under 29 CFR 1904.39 has presented
unique challenges. As noted above, for purposes of reporting COVID-19
fatalities and in-patient hospitalizations, OSHA has interpreted the
phrase ``the work-related incident'' in 29 CFR 1904.39(b)(6) to mean an
employee's ``exposure'' to COVID-19 in the work environment. Thus, in
order to be reportable, an in-patient hospitalization needed to occur
within 24 hours of an employee's exposure to COVID-19 in the work
environment. Given the incubation period of the virus, and the typical
timeframe between exposure and the emergence of symptoms serious enough
to require hospitalization, it is extremely unlikely for an in-patient
hospitalization to occur within 24 hours of an employee's exposure to
the virus.
To address these issues, paragraph (r)(1)(ii) does not limit the
COVID-19 reporting requirement to only those hospitalizations that
occur within 24 hours of exposure, as in 29 CFR 1904.39(b)(6). This
change in the reporting requirement will result in OSHA making more
determinations as to whether immediate investigations are needed at
additional worksites. Given the severity of the disease, and how
quickly it can spread, it is essential that remediation efforts at a
workplace be undertaken immediately. As noted above, it is critical for
OSHA to respond quickly to hazardous conditions where employees have
been hospitalized. The elimination of the 24-hour limitation period
will not only allow OSHA to receive more employer reports about work-
related COVID-19 in-patient hospitalizations and, as a result, shed
light on where severe COVID-19 events are occurring, but it will also
enable the agency to respond more quickly and effectively to these
situations. Accordingly, employers must report each work-related COVID-
19 in-patient hospitalization to OSHA regardless of when the employee's
exposure in the workplace occurred (paragraph (r)(1)(ii)). But
consistent with OSHA's normal reporting requirements, when
hospitalization for a work-related case of COVID-19 does occur, the
employer must report it within 24 hours of learning about the
hospitalization.
Additionally, for purposes of this section, OSHA defines in-patient
hospitalization as a formal admission to the in-patient services of a
hospital or clinic for care or treatment (see 29 CFR 1904.39(b)(9) and
(10)). The determination as to whether an employee is formally admitted
into the in-patient service is made by the hospital or clinic.
Treatment in an Emergency Room only is not reportable.
I. Work-Relatedness Determinations
Given the nature of the disease, and the extent of community
spread, in some cases, it may be difficult for an employer to determine
whether an employee's COVID-19 illness is work-related, especially when
an employee has experienced potential exposure both in and out of the
workplace. For purposes of this ETS, when evaluating whether a fatality
or in-patient hospitalization is the result of a work-related case of
COVID-19, employers must follow the criteria in OSHA's recordkeeping
regulation at 29 CFR 1904.5 for determining work-relatedness. Applying
the criteria in 29 CFR 1904.5 under paragraph (r) of this standard is
consistent with how employers make work-relatedness determinations when
reporting fatalities and other serious events under 29 CFR 1904.39.
Under Sec. 1904.5, employers must consider an injury or illness to
be work-related if an event or exposure in the work environment either
caused or contributed to the resulting condition, or significantly
aggravated a pre-existing injury or illness. An injury or illness is
presumed work-related if it results from events or exposures occurring
in the work environment, unless an exception in Sec. 1904.5(b)(2)
specifically applies. Under this language, an injury or illness is
presumed work-related if an event or exposure in the work environment
is a discernable cause of the injury or illness (see 66 FR 66,943
(December 27, 2001)).
According to 29 CFR 1904.5(b)(3), the ``work environment'' includes
the employer's establishment and any other location where work is
performed or where employees are present as a condition of their
employment. Under 29 CFR 1904.5(b)(3), employers should evaluate the
employee's work duties and environment and determine whether it is more
likely than not that exposure at work caused or contributed to the
illness (see 66 FR 5958-59 (January 19, 2001)).
Because of the typical incubation period of 3 to 14 days, an
employee's exposure to COVID-19 will usually be determined after the
fact. Employers must make reasonable efforts to acquire the necessary
information to make good-faith work-relatedness determinations under
this section. In addition, the employer should rely on information that
is reasonably available at the time of the fatality or in-patient
hospitalization.
A work-related exposure in the work environment would likely
include close contact with a person known to be infected with COVID-19
or common high-touch areas or items. For example, although work-
relatedness must be determined on a case-by-case basis, if a number of
COVID-19 illnesses develop among coworkers who work closely together
without an alternative explanation, it is reasonable to conclude that
an employee's fatality or in-patient hospitalization is work-related.
On the other hand, if there is not a known exposure to COVID-19 that
would trigger the presumption of work-relatedness, the employer must
evaluate the employee's work duties and environment to determine
whether it is more likely than not that the employee was exposed to
COVID-19 during the course of their employment. Employers should
consider factors such as:
The type, extent, and duration of contact the employee had
at the work environment with other people, particularly the general
public.
Physical distancing and other controls that impact the
likelihood of work-related exposure.
The extent and duration of time spent in a shared indoor
space with limited ventilation.
Whether the employee had work-related contact with anyone
who exhibited signs and symptoms of COVID-19.
Since 1971, under OSHA's recordkeeping system, employers have been
making work-relatedness determinations regarding workplace fatalities,
injuries, and illnesses. In general, employers are in the best position
to obtain information, both from the employee and the workplace,
necessary to make a work-relatedness determination. Although employers
may rely on experts and healthcare professionals for guidance, the
determination of work-relatedness ultimately rests with the employer.
OSHA anticipates that the vast majority of employers who are
subject to the reporting requirements in paragraph (r) of this ETS are
already familiar with OSHA's reporting requirements in 29 CFR 1904.39.
In fact, many of the healthcare providers subject to this ETS may have
been involved in assisting non-healthcare employers in making work-
relatedness determinations. OSHA expects that healthcare employers will
typically report confirmed cases of COVID-19 among employees working in
areas where suspected or confirmed COVID-19 patients are treated absent
evidence suggesting other sources. For example, if a nurse is working
on a hospital floor dedicated to the treatment and care of COVID-19
patients, and there is an outbreak among co-workers, it is likely that
a COVID illness contracted by the nurse is work-related, absent
evidence of an outside exposure.
Finally, OSHA wishes to emphasize that, under OSHA's recordkeeping
regulation at 29 CFR part 1904, employers must record on the OSHA 300
log each work-related fatality, injury, and illness reported to OSHA
under Sec. 1904.39. The work-relatedness determination for fatality
and in-patient hospitalization is no different than the requirement to
determine work-relatedness when entering fatalities, injuries and
illness on the OSH 300 log. Accordingly, the work-relatedness
determination for reporting COVID-19 fatalities and in-patient
hospitalizations is a determination that is already required to be made
by the employer.
II. Time Periods for Reporting COVID-19 Fatalities and In-Patient
Hospitalizations
As noted above, under paragraph (r), employers must report each
work-related COVID-19 fatality or hospitalization to OSHA within the
specified timeframes based on when any agent or employee of the
employer becomes aware of the reportable event. For example, an
employer ``learns'' of a COVID-19 fatality or in-patient
hospitalization when a supervisor, receptionist, or other employee at
the company receives information from a family member or medical
professional about an employee fatality or in-patient hospitalization.
It is the employer's responsibility to ensure that appropriate
instructions and procedures are in place so that managers, supervisors,
medical personnel, as well as other employees or agents of the company,
who learn of an employee's death or in-patient hospitalization due to
COVID-19 know that the company must make a report to OSHA.
Consistent with OSHA's regulation at 29 CFR 1904.39, the reporting
clock begins to run with the occurrence of the reportable event. Under
paragraph (r), in situations where the employer or the employer's agent
does not learn about the work-related COVID-19 fatality or in-patient
hospitalization right away, the employer must make the report to OSHA
within 8 hours for a fatality, or 24 hours for an in-patient
hospitalization, from the time the employer (or the employer's agent)
learns about the reportable event. For example, if an employee dies
from a work-related case of COVID-19 on Sunday at 6:00 a.m., but the
employer does not learn about the death until Monday at 8:00 a.m., the
employer has until 4:00 p.m. that day to make the report to OSHA.
Similarly, if an employee is in-patient hospitalized for a work-related
case of COVID-19 at 8:30 p.m. on Monday, but the employer or the
employer's agent(s) does not learn about the hospitalization until 9:00
a.m. the next day (Tuesday), then the employer would be required to
make the report to OSHA within 24 hours of learning of the in-patient
hospitalization (i.e., by 9:00 a.m. on Wednesday) (see 29 CFR
1904.39(b)(7)).
Likewise, if an employer does not learn right away that a
reportable fatality or in-patient hospitalization is work-related, the
employer must make the report to OSHA within 8 hours or 24 hours of
learning that the death or in-patient hospitalization was the result of
a work-related COVID-19 exposure. For example, if an employee is in-
patient hospitalized for a case of COVID-19 at 9:00 a.m. on Monday, but
the employer does not have enough information to make a work-
relatedness determination until 11:00 a.m. on Monday, then the employer
would be required to report the hospitalization within 24 hours of
learning that the hospitalization was work-related (i.e., by 11:00 a.m.
on Tuesday) (see 29 CFR 1904.39(b)(8)).
Finally, if an employer makes a report to OSHA concerning a work-
related COVID-19 in-patient hospitalization and that employee
subsequently dies from the illness, the employer does not need to make
an additional fatality report to OSHA.
III. How To Report COVID-19 Fatalities and In-Patient Hospitalizations
and What Information Must be Included in the Report
Paragraph (r)(2) of the standard provides that when reporting work-
related COVID-19 fatalities and in-patient hospitalizations to OSHA in
accordance with paragraph (r)(1), the employer must follow the
requirements in 29 CFR part 1904.39, except for 29 CFR 1904.39(a)(1)-
(2) and (b)(6). As explained above, OSHA has included specific
provisions for the reporting of work-related COVID-19 fatalities and
in-patient hospitalizations that differ from 29 CFR 1904.39. However,
when making COVID-19 fatality and in-patient hospitalization reports to
OSHA, employers must follow the other reporting procedures set forth in
Sec. 1904.39. Specifically, under Sec. 1904.39(a)(3), employers have
three options for reporting work-related fatalities and in-patient
hospitalizations to OSHA:
1. By telephone to the OSHA Area Office that is nearest to the site
of the incident;
2. By telephone to the OSHA toll-free central telephone number, 1-
800-321-OSHA (1-800-321-6742);
3. By electronic submission using the reporting application located
on OSHA's public website at www.osha.gov.
Section 1904.39(a)(3) also allows employers to report work-related
fatalities and in-patient hospitalizations to OSHA in person to the
OSHA Area Office that is nearest to the site of the incident. However,
because many OSHA Area Offices are closed to the public during the
COVID-19 pandemic, employers must use one of the three options listed
above. In addition, Sec. 1904.39(b)(1) makes clear that, if the OSHA
Area Office is closed, an employer may not report a work-related
fatality or in-patient hospitalization by leaving a message on OSHA's
answering machine, faxing the Area Office, or sending an email.
Instead, the employer must make the report by using the 800 number or
the reporting application located on OSHA's public website at
www.osha.gov.
The other provisions in 29 CFR 1904.39 (except for 29 CFR
1904.39(a)(1) and(2) and (b)(6)) also apply to the reports required by
paragraph (r). For example, employers should consult 29 CFR
1904.39(b)(2) to determine what information employers must give to OSHA
when making reports of COVID-19 fatality or in-patient hospitalization.
Per that provision, employers must give OSHA the following information
for each fatality or in-patient hospitalization: The establishment
name, the location of the work-related incident, the time of the work-
related incident, the type of reportable event (i.e., fatality or in-
patient hospitalization), the number of employees who suffered a
fatality or in-patient hospitalization, the names of the employees who
suffered a fatality or in-patient hospitalization, the employer's
contact person and his or her phone number, and a brief description of
the work-related incident.
References
Centers for Disease Control and Prevention. (2020, May 20).
Reporting and Coding Deaths Due to COVID-19. https://www.cdc.gov/nchs/covid19/coding-and-reporting.htm. (CDC, May 20, 2020).
Pappas, S. (2020, May 19). How COVID-19 Deaths are Counted.
Scientific American. https://www.scientificamerican.com/article/how-
covid-19-
deaths-are-counted1/. (Pappas, May 19, 2020).
R. Dates
To minimize transmission of COVID-19 in the workplace, it is
essential that employers ensure that the provisions of this ETS are
implemented as quickly as possible, but no later than the dates
outlined in paragraph (s). This paragraph sets forth the effective date
of the section and the compliance dates for specific requirements of
the standard. Additionally, paragraph (e) of the mini respiratory
protection program section of this ETS (29 CFR 1910.504) contains the
effective date for that section. The effective date for both the
healthcare and the mini respiratory protection program sections, as
required by section 6(c)(1) of the OSH Act (29 U.S.C. 655(c)(1)), is
the date of publication in the Federal Register. The compliance date
for all provisions in the healthcare section is 14 days after the
effective date, except for paragraphs (i), (k), and (n), which must be
complied with within 30 days of the effective date. Given the delayed
compliance dates in this section, and the fact that the mini
respiratory protection program section applies only to respirator use
in accordance with certain provisions in this section, OSHA has
determined it is unnecessary to also include compliance dates in the
mini respiratory protection program section. The Secretary determined
that all requirements under Sec. Sec. 1910.502 and 1910.504 are
necessary and feasible. Given the grave danger to healthcare employees
from occupational exposure to COVID-19, as previously described, the
effective date and compliance dates provided for this ETS are
reasonable and appropriate.
For over a year--since at least January 2020, when the Secretary of
Health and Human Services declared COVID-19 to be a public health
emergency for the entire United States--all healthcare employers have
been made acutely aware of the importance of minimizing employees'
exposure to COVID-19 and many have willingly joined the global response
to stop the spread of COVID-19. Therefore, OSHA anticipates that many
healthcare employers will already be compliant with many of the
requirements of this standard by the effective date. However, the rule
provides flexibility for employers who may need some time to become
compliant with all of the provisions in the ETS. OSHA set the
compliance dates to allow sufficient time for employers to obtain and
read the standard, figure out its requirements, and undertake the
necessary steps for compliance.
OSHA anticipates that employers will be able to implement measures
to comply with most provisions of the standard within 14 days. Even in
situations where an employer has not previously taken the necessary
steps to address COVID-19 hazards in the workplace, the requirements
for COVID-19 plans, physical distancing, and most other measures
required under the standard can readily be met within the 14-day time
period. These measures do not require extensive lead times to
implement. Similarly, the mini respiratory protection program in Sec.
1910.504 was expressly designed to simplify compliance for employers,
and such a program can be readily implemented.
The standard provides a longer period of time for employers to
comply with the requirements for physical barriers. Paragraph (i)
requires the use of cleanable or disposable solid barriers at fixed
work locations outside of direct patient care areas when physical
distancing cannot be maintained, unless the employer can demonstrate
barriers are not feasible. Many employers installed physical barriers
prior to the publication of this ETS in order to mitigate the risks of
COVID-19 exposure, but OSHA anticipates that some employers may need to
adjust existing barriers or install new barriers to comply with the
standard. Some of these employers may find it necessary to use designs
that require custom fabrication or installation by contractors.
Consequently, the standard provides 30 days from the date of
publication before compliance with the provision addressing physical
barriers is required so that employers have adequate time, where
necessary, to design and install effective barriers in their
workplaces.
The standard also provides a longer period of time for employers to
comply with the ventilation requirements. Paragraph (k) requires
employers to ensure existing HVAC systems serving their workplace are
used in accordance with the HVAC manufacturer's instructions, the
design specifications of the HVAC system(s), and the requirements in
this paragraph. The ventilation provision also requires employers to
ensure the use of MERV-13 filters or the highest-efficiency filters
that are compatible with their HVAC system and to replace filters as
necessary. OSHA anticipates that some employers may need additional
time to assess their existing HVAC systems to ensure they are operating
in accordance with the requirements of the standard, including
upgrading filters when necessary. For example, some employers may need
to make arrangements with an HVAC technician to assess, adjust, and
maintain the HVAC system. Consequently, the standard provides 30 days
from the date of publication in the Federal Register before compliance
with the provisions addressing ventilation of workplaces is required.
Finally, OSHA has provided employers with additional time (again,
30 days from the effective date) to comply with the training
requirements in paragraph (n). Paragraph (n) requires employers to
provide training to each employee and, as per paragraph (n)(3) of that
section, to ensure that the training is overseen or conducted by a
person knowledgeable in the covered subject matter as it relates to the
employee's job duties. Additionally, paragraph (n)(4) requires training
which provides an opportunity for interactive questions and answers
with a person knowledgeable in the covered subject matter. Because of
these additional requirements, OSHA recognizes that employers may need
more time to fully meet the training requirements in paragraph (n).
Therefore, the standard requires compliance with the training
provisions in the healthcare section within 30 days from the date of
publication in the Federal Register.
Compliance with the requirements of the ETS within the specified
dates is achievable. Many employers are likely already in compliance
with many of the provisions of the ETS, such as provisions for physical
distancing, physical barriers, and cleaning and disinfection. Resources
are also readily available to help employers achieve compliance. These
resources include guidance issued by OSHA, the CDC, state and local
governments, trade associations, and other organizations to help
employers understand the risks and successfully minimize the
transmission of COVID-19 in the workplace. OSHA therefore concludes
that the compliance dates in this ETS are reasonable.
Still, OSHA's experience with promulgating standards shows that, in
isolated circumstances, some employers will, despite their best
efforts, be unable to comply with all requirements by the specified
compliance dates. In particular, OSHA recognizes that requirements for
physical barriers and ventilation may involve factors that are outside
of the employer's control. For example, in exceptional circumstances,
specialized barriers may require design, fabrication, and installation
that may require more than 30 days to complete. OSHA is willing to use
its enforcement discretion in situations where an
employer can show it has made good-faith efforts to comply with the
requirements of the standard, but has been unable to do so.
S. Mini Respiratory Protection Program
Compliance with the mini respiratory protection program section of
the ETS (29 CFR 1910.504) is required whenever respirators are used in
lieu of required facemasks under Sec. 1910.502. The mini respiratory
protection program is designed to improve employee protections during
the pandemic by streamlining respiratory protection program
requirements under the ETS. This program provides a limited set of
requirements for the safe use of respirators; these requirements are
meant to be easier and quicker to implement than the more comprehensive
respiratory protection program under 29 CFR 1910.134. OSHA designed the
mini respiratory protection program to allow employers and employees
increased flexibility in selecting respirators while ensuring that
employees remain protected. The rationale for including the mini
respiratory protection program section in the ETS is discussed in more
detail in the Need for Specific Provisions (Section V of the preamble).
Paragraph (a) establishes that the mini respiratory protection
program section applies only to respirator use in accordance with Sec.
1910.502 (f)(4). In any other situation where respirator use is
required under the ETS (or another OSHA standard), the employer must
follow the requirements in OSHA's respiratory protection standard, 29
CFR 1910.134. This includes when respirator use is required under Sec.
1910.502 (f)(2)(i) for exposure to people with suspected or confirmed
COVID-19; under Sec. 1910.502 (f)(3)(i) for aerosol-generating
procedures performed on a person with suspected or confirmed COVID-19;
under Sec. 1910.502 (f)(5) based on Standard and Transmission-Based
Precautions; and where respirator use is required for protection from
any hazards other than COVID-19.
Under Sec. 1910.502 (f)(4), employers must comply with the mini
respiratory protection program section when they elect to provide a
respirator to an employee instead of a facemask (paragraph (f)(4)(i))
or permit an employee to wear an employee-provided respirator instead
of a facemask (paragraph (f)(4)(ii)).
Paragraph (b) of the mini respiratory protection program section
contains the definitions used in that section. Most of the definitions
have already been discussed in other sections of the preamble. The
previously discussed definitions are COVID-19, elastomeric respirator,
filtering facepiece respirator, hand hygiene, respirator, and powered
air-purifying respirator (PAPR). The definitions of tight-fitting
respirator, and user seal check are explained below, where paragraph
(d)(2) is discussed.
Paragraph (c) of the mini respiratory protection program section
applies to respirators provided by employees, as opposed to employer-
provided respirators. When the employer permits an employee to use the
employee's own respirator under Sec. 1910.502(f)(4)(ii), the employer
must provide the employee with a specific notice, the text of which is
included in paragraph (c) of the mini respiratory protection program
section. The notice is similar to the notice provided to employees for
voluntary respirator use under 29 CFR 1910.134, Appendix D. It explains
that respirators can provide effective protection against COVID-19
hazards when properly selected and worn, but notes that a respirator
can itself become a hazard if used improperly or not kept clean. The
notice also instructs employees to read and follow the respirator
manufacturer's instructions and warnings and to ensure that they do not
mistakenly use another person's respirator. Further, the notice tells
employees that if they need a respirator for a non-COVID-19 hazard,
such as a chemical hazard, then their employer must provide them with a
respirator and ensure that it is used in accordance with 29 CFR
1910.134. Employers that must comply with this paragraph have
substantial flexibility in how they provide the information to the
employee. The agency expects that most employers will simply provide
the information in written form, either through a printed page of
information or electronically through a company email system. Employers
could also deliver the information orally through a training session.
Paragraph (d) of the mini respiratory protection program section
applies to employer-provided respirators, in contrast to employee-
provided respirators. Paragraph (d) applies whenever employers provide
respirators, instead of facemasks, to their employees under Sec.
1910.502(f)(4)(i). The use of FFRs, elastomeric respirators, and PAPRs
is covered under paragraph (d), although a small number of individual
provisions apply only to particular categories of respirators (e.g.,
paragraph (d)(3)(i) of the mini respiratory protection program section
applies only to FFRs).
Paragraph (d)(1) of the mini respiratory protection program section
requires employers to ensure that each employee wearing a respirator
receives training prior to first use of the respirator and whenever the
employee begins using a different type of respirator. Employee training
is an essential component of any OSHA standard, and is needed so
employees understand the requirements of the standard and what must be
done to keep themselves safe. In keeping with other OSHA training
requirements, the training must be given in a language and at a
literacy level the employee understands. The training must result in
employee comprehension of how to inspect, put on, use, and remove the
respirator. The employee must also understand the limitations and
capabilities of the respirator, including limitations when the
respirator has not been fit tested. Because employees are not required
to be fit tested under the mini respiratory protection program section
as they are under 29 CFR 1910.134, a key aspect of this portion of the
training is to emphasize that without a fit test, an employer has less
control over whether employees are receiving the full, expected level
of protection that a respirator is capable of providing to the wearer.
In the absence of a fit test, the employer should inform the employee
that a user seal check is very important to determining whether the
respirator is properly placed on their face in order to allow the
respirator to function as intended. After the training is provided, the
employee must also comprehend the proper way to store, maintain, and
inspect the respirator; how to perform a user seal check; and how to
recognize medical signs and symptoms that may limit or prevent the
effective use of the respirator, along with what to do if the employee
experiences those signs and symptoms.
Employers have substantial flexibility regarding the format in
which training is provided under the mini respiratory protection
program section of this ETS. The training can be provided along with
the other training required under Sec. 1910.502(n), or it can be
provided separately. Training may be provided in-person, remotely
through online training, or by distributing educational materials. The
requirement for employee comprehension of the training materials does
not require a formal test and may be assessed in other ways so long as
the employer can ensure that the requirement for comprehension has been
met. Employers looking for training resources on respiratory protection
can consult OSHA's website for materials and information.
Paragraph (d)(2) of the mini respiratory protection program section
requires the employer to ensure that each employee who uses a tight-
fitting
respirator performs a user seal check each time they put on the
respirator. A tight-fitting respirator is defined as a respirator in
which the air pressure inside the facepiece is negative during
inhalation with respect to the ambient air pressure outside the
respirator (e.g., filtering facepiece). Tight-fitting respirators
include all FFRs (e.g., N95s) and most elastomeric respirators, and
under paragraph (d)(2) of the mini respiratory protection program
section, they require a user seal check. Many PAPRs used in healthcare
settings are loose-fitting and therefore do not require a user seal
check. User seal check is defined as an action conducted by the
respirator user to determine if the respirator is properly seated to
the user's face. A user seal check ensures an adequate seal is
achieved, and can be conducted by either a positive pressure or
negative pressure check.
Under paragraph (d)(2) of the mini respiratory protection program
section, employers must ensure that employees perform a user seal check
each time a tight-fitting respirator is put on. This requirement is
meant to ensure that the respirator is properly seated on the user's
face (i.e., that the proper seal has been achieved) whenever they are
wearing it. Paragraphs (d)(2)(i)(A) and (B) of the mini respiratory
protection program section explain methods for conducting positive
pressure and negative pressure seal checks. Both methods require, as
the first step, that the employee conducts proper hand hygiene and
properly dons their respirator. When conducting hand hygiene in most
clinical settings, the CDC recommends use of an alcohol-based hand rub
over soap and water, unless hands are visibly soiled; this is due to
evidence of better compliance with the use of hand rub compared to soap
and water. However, the CDC does recommend that healthcare workers wash
their hands for at least 20 seconds with soap and water when hands are
visibly dirty, before eating, and after using the restroom (CDC, May
17, 2020).
As described in paragraph (d)(2)(i)(A), the proper method for
conducting a positive pressure user seal check is to have the employee
exhale into the respirator while covering the filter surface with their
hands. If there is no evidence of leaks and the employee can feel a
slight outward pressure on the surface of the respirator, proper fit
has likely been achieved and the fit is considered satisfactory. The
proper method for performing a negative pressure user seal check, under
paragraph (d)(2)(i)(B), is to have the employee inhale while covering
the filter surface with their hands. Proper fit has likely been
achieved, and the fit is considered satisfactory, if the respirator
collapses on the face and the employee does not feel air passing
between their face and the facepiece of the respirator. Paragraph
(d)(2)(ii) of the mini respiratory protection program section requires
the employer to ensure that the employee corrects any seal problems
discovered during the user seal check by readjusting how the respirator
sits on the employee's face, readjusting the nosepiece, if applicable,
and readjusting the straps along the sides of the head.
When an employee is required to wear a respirator and a problem
with the seal check arises due to interference with the seal by an
employee's facial hair, a note to paragraph (d)(2)(i) and (ii) of the
mini respiratory protection program section reminds employers that they
may provide a different type of respirator to accommodate an employee
who cannot trim or cut facial hair due to their religious beliefs. In
such cases, if the employee cannot achieve a seal with a FFR or
elastomeric respirator, a loose-fitting PAPR may be the only
alternative that provides effective protection.
Paragraph (d)(3) of the mini respiratory protection program section
describes the requirements employers must follow for reuse of
respirators that are provided by the employer, with specific
requirements for FFRs (paragraph (d)(3)(i)) and for elastomeric
respirators and PAPRs (paragraph (d)(3)(ii)). Reuse of respirators has
been necessary in some cases during the COVID-19 pandemic, particularly
at the beginning of the pandemic when shortages of respirators were
most acute. When respirators are reused, it is important that proper
procedures are followed and that reuse is limited to ensure they
continue to effectively protect the user.
Paragraph (d)(3)(i) of the mini respiratory protection program
section describes the requirements for reuse of FFRs. FFRs are designed
and manufactured as disposable items of personal protective equipment
that should normally be discarded after a single use. Therefore, the
note to paragraph (d)(3)(i) states that reuse of single-use respirators
is discouraged. Reuse of FFRs used under this section, however, poses
less of a concern than reuse of respirators used in other situations,
given that there should be no suspected or confirmed sources of COVID-
19 present when such reuse occurs. Even so, it is important that reuse
of FFRs is permitted only under the conditions set out in paragraph
(d)(3)(i).
There are several requirements for the reuse of FFRs under
paragraph (d)(3)(i) of the mini respiratory protection program section.
The employer must ensure that an FFR is only reused by one employee,
and that it is only reused when not visibly soiled or damaged. The
employer must ensure that the employee visually checks the respirator's
fabric and seal for damage in adequate lighting. In addition, the
employer must ensure that the employee completes the user seal check
(as described in paragraph (d)(2) of the same section) before each use.
As explained earlier, the user seal check is needed to ensure the
respirator is properly seated on the user's face. The employer must
also ensure that the employee uses proper hand hygiene before putting
on their respirator and conducting the user seal check. Proper hand
hygiene will help keep the respirator clean and avoid the transmission
of potentially infectious material from the employee's hands to the
respirator.
The employer must ensure that each FFR reused in accordance with
paragraph (d)(3)(i) of the mini respiratory protection program is not
worn for more than five days, in total. This limit is generally
consistent with CDC guidance, which recommends that, in the absence of
guidance from the manufacturer, reuse be limited to no more than five
uses per device to ensure adequate respirator performance (CDC, April
9, 2021). The CDC's technical literature regarding how to ensure safe
reuse of an FFR discusses the number of times a user may don a single
FFR, as well as variability among FFRs made by different manufacturers.
Given these factors, OSHA has set the limit at five days to provide
flexibility and improve the feasibility of the standard, while ensuring
employees remain protected. It should also be noted that the inspection
of the respirator, as well as the user seal check, both of which must
be performed by the employee each time a respirator is put on, provide
additional safeguards to ensure the respirator is still in proper
condition for reuse. It is also important that employers track usage to
ensure that each respirator is discarded after five days of use. One
way to do so is to attach a small tag to a respirator strap and mark it
after each day's use. Similarly, a tag could be attached to the
respirator's storage bag to track total use, or the information could
be written directly on a paper bag.
Finally, under paragraph (d)(3)(i) of the mini respiratory
protection program, employers must also ensure that each reused
respirator is stored in a breathable container, such as a paper
bag or hard container with air holes, for at least five calendar days
between use. This provides time for pathogens that may be on the
respirator to ``die off'' during storage and avoids exposing the
employee to those pathogens during subsequent usage. The respirator
must also be stored in a dry place to avoid exposure to water and
moisture, which could deform the respirator and lead to poor fit.
Combining the five-day total use limitation with the five-day rest
requirement, the employer could direct the employee to wear one FFR
each day and store it in a breathable paper bag at the end of each day,
rotating to the next respirator each day. This strategy requires a
minimum of five FFRs per five-day period per employee and an effective
and user-friendly tracking system to make sure that each respirator is
used in the proper sequence. The five respirators, each used five
times, would provide respiratory protection for the employee for 25
days. More information on FFR reuse is available from the CDC (October
19, 2020).
Paragraph (d)(3)(ii) of the mini respiratory protection program
section contains the requirements employers must comply with when
employees are reusing elastomeric respirators and PAPRs that are
provided by the employer. Reusing these respirators is much simpler
than reusing FFRs because elastomeric respirators and PAPRs are
designed for reuse and made of more durable materials. The employer
must ensure that the respirator is not damaged, which will be
identified when the employee inspects the respirator before each use.
The respirator must be cleaned and disinfected as often as necessary to
be maintained in a sanitary condition following the requirements of 29
CFR 1910.134, Appendix B-2. Further, the employer must implement a
change schedule for filter cartridges, canisters, or filters that is
consistent with the manufacturer's recommendations. For more
information about reuse of elastomeric respirators and PAPRs during the
pandemic, refer to the CDC Guidance for Contingency and Crisis
Strategies (CDC, October 13, 2020; CDC, November 3, 2020,
respectively).
Finally, paragraph (d)(4) of the mini respiratory protection
program section requires the employer to ensure that an employee
discontinues use of a respirator if the employee or supervisor reports
medical signs or symptoms related to the employee's ability to use a
respirator. These signs and symptoms include shortness of breath,
coughing, wheezing, or chest pain. They also include any signs or
symptoms related to problems associated with lung or cardiovascular
function. If an employee has had a previous medical evaluation that
determined they were medically unfit for respirator use, the employer
must not provide them with a respirator until they are re-evaluated and
medically cleared to use a respirator. These provisions are necessary
because the medical evaluation that would normally be required by the
29 CFR 1910.134 respiratory protection standard is not required in the
mini respiratory protection program section, and it is important to
ensure that employee health is not compromised by respirator use.
Paragraph (e) contains the effective date for the mini respiratory
protection program. The effective date is consistent with the effective
date for Sec. 1910.502; the mini respiratory protection program
section becomes effective on the date of publication. A compliance date
specific to the mini respiratory protection program is not included, as
compliance with these provisions would be required on the compliance
dates for Sec. 1910.502(f) (i.e., within 14 days of publication). For
more information on compliance dates, please see the Summary and
Explanation on Dates (Section VIII of this preamble).
References
Centers for Disease Control and Prevention (CDC). (2020, May 17).
Hand hygiene recommendations: Guidance for healthcare providers
about hand hygiene and COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/hand-hygiene.html. (CDC, May 17, 2020).
Centers for Disease Control and Prevention (CDC). (2020, October
13). Elastomeric respirators: Conventional, contingency, and crisis
strategies. https://www.cdc.gov/coronavirus/2019-ncov/hcp/elastomeric-respirators-strategy/index.html. (CDC, October 13,
2020).
Centers for Disease Control and Prevention (CDC). (2020, October
19). Implementing Filtering Facepiece Respirator (FFR) Reuse,
Including Reuse after Decontamination, When There Are Known
Shortages of N95 Respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html#print.
(CDC, October 19, 2020).
Centers for Disease Control and Prevention (CDC). (2020, November
3). Considerations for Optimizing the Supply of Powered Air-
Purifying Respirators (PAPRs). https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/powered-air-purifying-respirators-strategy.html. (CDC, November 3, 2020).
Centers for Disease Control and Prevention (CDC). (2021, April 9).
Strategies for optimizing the supply of N95 respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html. (CDC, April 9, 2021).
T. Severability
The severability clause under 29 CFR 1910.505 of this ETS serves
two purposes. First, it expresses OSHA's intent that if any section or
provision of the ETS is held invalid or unenforceable or is stayed or
enjoined by any court of competent jurisdiction, the remaining sections
or provisions should remain effective and operative. Second, the
severability clause also serves to express OSHA's judgment, based on
its technical and scientific expertise, that each individual section
and provision of the ETS can continue to sensibly function in the event
that some sections or provisions are invalidated, stayed, or enjoined.
Under the principle of severability, a reviewing court will
generally presume that an offending provision of a regulation is
severable from the remainder of the regulation, so long as that outcome
appears consistent with the issuing agency's intent, and the remainder
of the regulation can function sensibly without the offending
provision. See K Mart Corp. v. Cartier, Inc., 486 U.S. 281, 294 (1988)
(invalidating and severing subsection of a regulation where it would
not impair the function of the statute as a whole and there was no
indication the regulation would not have been passed but for inclusion
of the invalidated subsection); Virginia v. EPA, 116 F.3d 499, 501
(D.C. Cir. 1997) (same); Davis Cnty. Solid Waste Mgmt. v. EPA, 108 F.3d
1454, 1459-60 (D.C. Cir. 1997) (same). The principle of severability
has always applied to OSHA's standards, including OSHA's prior ETSs,
and reviewing courts have regularly severed invalid provisions, or
prohibited invalid applications, of both OSHA's permanent and emergency
standards, while allowing the remainder of the standards to continue in
effect. See e.g., Am. Dental Ass'n v. Martin, 984 F.2d 823, 830-31 (7th
Cir. 1993) (affirming and allowing most of OSHA's bloodborne pathogens
standard to take effect while vacating application of the standard to
certain employers); United Steelworkers of Am., AFL-CIO-CLC v.
Marshall, 647 F.2d 1189, 1311 (D.C. Cir. 1980) (affirming and allowing
most of OSHA's lead standard to take immediate effect while staying
application of the standard to certain industries pending further
agency action); Dry Color Mfrs. Ass'n, Inc. v. Dep't of Labor, 486 F.2d
98, 108-09 (3d Cir. 1973) (vacating and remanding OSHA's ETS on
carcinogens as to only 2 of 14 regulated chemicals, allowing ETS to
take effect as to
remaining 12 chemicals); cf. N. Am.'s Bldg. Trades Unions v. OSHA, 878
F.3d 271, 309 (D.C. Cir. 2017) (affirming and allowing all of OSHA's
silica standard to take effect while remanding for reconsideration of
decision not to require broader medical removal protection provisions).
With respect to this ETS, it is OSHA's intent that all provisions
and sections be considered severable. In this regard, the agency
intends that: (1) In the event that any provision within a section of
the ETS is stayed, enjoined, or invalidated, all remaining provisions
within that section shall remain effective and operative; (2) in the
event that any whole section of the ETS is stayed, enjoined, or
invalidated, all remaining sections shall remain effective and
operative; and (3) in the event that any application of a provision is
stayed, enjoined, or invalidated, the provision shall be construed so
as to continue to give the maximum effect to the provision permitted by
law. Although OSHA always intends for a presumption of severability to
be applied to its standards, the agency has opted to include an
explicit severability clause in this ETS to remove any potential for
doubt as to its intent. OSHA determined that such clarity is useful
here given the unique nature of this emergency rulemaking proceeding,
the unprecedented hazard at issue, and the urgent need for
implementation of this ETS without delay. Having identified a grave
danger to healthcare employees that requires immediate emergency
rulemaking (see Section IV of the preamble), it is OSHA's intent to
have as many protective measures in place as quickly as possible to
begin to reduce the hazard of exposure to COVID-19 in the workplace.
Thus, should a court of competent jurisdiction determine that any
provision or section of this ETS is invalid on its face or as applied,
the court should presume that OSHA would have issued the remainder of
the ETS without the invalidated provision(s) or application(s).
Similarly, should a court of competent jurisdiction determine that any
provision, section, or application of this ETS is required to be stayed
or enjoined, the court should presume that OSHA intends for the
remainder of the ETS to take effect as specified in the rule. See Casa
de Maryland, Inc. v. Wolf, 486 F. Supp. 3d 928, 973 (D. Md. 2020)
(noting that existence of a severability clause creates a presumption
that the agency did not intend the validity of the remaining rules to
depend on the validity of the offensive provision and thus without
strong evidence to the contrary objectionable provision should be
severed); Consumer Fin. Prot. Bureau v. Mortg. Law Grp., LLP, 182 F.
Supp. 3d 890, 894-95 (W.D. Wis. 2016) (finding severability clause a
clear expression of agency intent and therefore severing specific
offending requirements within an otherwise valid provision); cf. Alaska
Airlines, Inc. v. Brock, 480 U.S. 678, 686 (1987) (holding that
inclusion of a severability clause in a statute creates a presumption
of Congress's intent).
It is also OSHA's position, based on its technical and scientific
expertise, that each of the provisions and sections of the ETS can
continue to function sensibly in the event that any specific
provisions, sections, or applications are invalidated, enjoined, or
stayed. As explained in greater detail in Need for Specific Provisions
(Section V of this preamble), and specifically in the subsection
Introduction--Effective Infection Prevention Utilizes Overlapping
Controls, the best available evidence shows that each control measure
required by this ETS is important both individually and collectively to
protect healthcare employees from the grave danger of COVID-19. The ETS
requires employers to implement multiple infection control measures
together because an infection control program is most effective when it
utilizes a suite of overlapping controls in a layered approach. This
ensures that no inherent weakness in any one measure will result in an
infection incident. As noted in Section V of the preamble, this is
commonly referred to as the ``Swiss Cheese Model of Accident
Causation,'' which recognizes that each control has certain weaknesses
or ``holes,'' and that by stacking several controls together with
different weaknesses, the ``holes'' are blocked by the strengths of the
other controls. However, while these control measures work best when
used together, each individual measure will still independently result
in some reduction of risk to employees, regardless of the
implementation of any other measure. Indeed, to the extent any
individual measures are not implemented, the remaining measures become
increasingly more important as a means of reducing the hazard of COVID-
19 to which employees are exposed. Accordingly, if a court of competent
jurisdiction were to invalidate, enjoin, or stay any protections
required by this ETS, the remaining protections would still serve to
reduce the risk of employee exposure to COVID-19--becoming more
important in that role absent the invalidated, enjoined, or stayed
provisions--and, therefore, should be allowed to take effect. Moreover,
as described in greater detail in Technological Feasibility (Section
VI.A. of the preamble), each of the individual protective measures
required by this ETS is capable of being implemented independent of all
other measures. While OSHA has emphasized throughout this rule that a
multilayered approach is intended for the ETS, the various requirements
imposed by this ETS are not required to rise or fall as a whole.
OSHA notes that 29 CFR 1910.504, the mini respiratory protection
program, applies only to respirator use in accordance with Sec.
1910.502(f)(4). Thus, in the event that Sec. 1910.502(f)(4)
specifically is stayed, enjoined, or invalidated, the mini respiratory
protection program should also be stayed, enjoined, or invalidated, as
it cannot function sensibly in that context. OSHA also notes that in
the event that the entirety of 29 CFR 1910.502 is stayed, enjoined, or
invalidated, the remaining sections of the ETS--including the mini
respiratory protection program, severability, and incorporation by
reference--should also be stayed, enjoined or invalidated, as their
implementation is dependent on the existence of Sec. 1910.502.
The severability clause contained in the ETS is included to make
clear OSHA's intent that the general presumption of severability should
be applied to this standard. The clause is further included to make
clear that, in the agency's scientific and technical judgment, and with
the exceptions noted above, the severance of any provisions, sections,
or applications of this ETS will not undercut the structure or function
of the rule more broadly. Consequently, in the event that a court of
competent jurisdiction stays, enjoins, or invalidates any provision,
section, or application of this ETS, the remainder of the rule should
be allowed to take effect, particularly given the urgent need to
address the grave danger COVID-19 poses to healthcare employees.
U. Incorporation by Reference
OSHA's ETS incorporates by reference a number of consensus
standards and evidence-based guidelines. Those documents, which are
listed below, will all be fixed in time and made publicly available. To
aid readers in locating the publicly available copies of those
documents, OSHA has created a new centralized incorporation by
reference (IBR) section, 29 CFR 1910.509, that is specific to the ETS
provisions in subpart U of 29 CFR part 1910. For the benefit of the
reader and for administrative convenience, this centralized IBR section
is located in the
same subpart. If the ETS is not made permanent, 29 CFR 1910.509 will
expire along with the rest of subpart U. If the ETS is made permanent,
OSHA intends to recodify the standards from 29 CFR 1910.509 into 29 CFR
1910.6, the centralized IBR section for part 1910.
In this new section, OSHA is including a list of the titles,
editions/versions, and years of the incorporated documents.
Stakeholders may consult 29 CFR 1910.509 both to locate all of the
documents incorporated by reference in subpart U (the paragraph in
which the document is incorporated is listed there) and to find more
details regarding how to locate the specific consensus standard and
guidelines that have been incorporated by reference in the ETS.
OSHA recognizes that the Centers for Disease Control and Prevention
(CDC) and the Environmental Protection Agency (EPA) may update their
guidelines based on the most current available scientific evidence, but
OSHA is only requiring compliance with the standards or guidelines
incorporated by reference, which are fixed in time at the point of
publication.
OSHA notes that the ETS largely tracks CDC guidance, some of which
is labeled as recommendations or guidance and is not always expressed
in mandatory terms. As discussed in the Need for the ETS (Section IV.B.
of this preamble), while non-mandatory guidance has been effective for
informing the public, it is not sufficiently protective, and thus is
not a meaningful alternative to a mandatory standard. The CDC has
limited regulatory authority, such that many of its recommendations are
framed in non-mandatory terms, including the documents incorporated by
reference in this ETS. Nevertheless, as discussed in detail elsewhere
in this preamble, OSHA has reviewed those materials and determined that
compliance with the safety measures and specific instructions in the
CDC materials is important to protect workers. OSHA is concerned that
converting these hundreds of pages into regulatory text would be
cumbersome and make the ETS more difficult for employers and employees
to understand and comply with. Moreover, OSHA believes that many
employers and employees are already familiar with existing CDC
materials and thus incorporation by reference will therefore facilitate
compliance. Therefore, while OSHA is incorporating those materials by
reference, compliance with the recommendations will be mandatory. OSHA
will be able to cite employers who do not follow them. Compliance with
all applicable provisions of the incorporated document is required
where the provisions into which they are incorporated are mandatory,
whether the incorporated document sets out its directions in mandatory
language or recommendations. OSHA recognizes that the documents
incorporated by reference into the ETS may become outdated when newer
versions of those documents are published or other entities revise
those documents. In that case, OSHA will work quickly to update the ETS
through a new rulemaking or issue enforcement guidance, as appropriate.
But OSHA also has a longstanding de minimis enforcement policy to allow
employers to rely on documents that are at least as protective.
OSHA is incorporating by reference (in 29 CFR 1910.509) the
materials below. A brief description of each consensus standard and
guideline is provided in the text below. A description of their use can
be found in the Regulatory Text, and Summary and Explanation (Section
VIII of this preamble), where the standards and guidelines are
referenced.
Regulatory Text--Sec. 1910.502(b)
ANSI/ISEA Z87.1 (2010, 2015, and 2020) Occupational and Educational
Personal Eye and Face Protection Devices: These consensus standards,
versions dated 2010, 2015, and 2020, provide criteria and requirements
for selection, use, and maintenance of the different face and eye
protectors to eliminate hazards such as liquid splash and droplets
exposures in occupational and educational environments. The 2010
version was updated in 2015 and 2020 to add new and innovative designs
and streamline language. These consensus standards are available for
purchase at https://webstore.ansi.org/.
Regulatory Text--Sec. 1910.502(j)(2)(ii)
CDC's Cleaning and Disinfecting Guidance (2021): This guidance
provides direction on cleaning and disinfecting frequently touched
surfaces, materials, and equipment regularly or when contaminated by a
person who is COVID-19 positive using appropriate disinfectants and
other equipment. This document is available at www.osha.gov/coronavirus/ets/ibr.
Regulatory Text--Sec. 1910.502(d)(3); 1910.502(j)(1)
CDC's COVID-19 Infection Prevention and Control Recommendations
(2021): This guidance provides recommendations for routine infection
prevention and control practices in healthcare settings to protect
healthcare workers. This document is available at www.osha.gov/coronavirus/ets/ibr.
Regulatory Text--Sec. 1910.502(e); 1910.502(f)(5)
CDC's Guidelines for Isolation Precautions (Updated 2019): These
guidelines provide direction on developing, implementing, and
evaluating infection control programs for healthcare settings across a
variety of care. It also provides guidance on reducing the prevalence
of hospital-acquired infections. This document is available at
www.osha.gov/coronavirus/ets/ibr.
Regulatory Text--Sec. 1910.502(j)(1)
CDC's Guidelines for Environmental Infection Control (2019): These
guidelines provide evidence-based strategies for the prevention of
environmentally mediated infection among healthcare workers and
immunocompromised patients. Pages 86-103 and 147-149 focus on
Environmental Services in healthcare settings. This document is
available at www.osha.gov/coronavirus/ets/ibr.
Regulatory Text--Sec. 1910.502(l)(6)
CDC's Isolation Guidance (2021): This guidance provides steps to
take when someone is experiencing COVID-19 symptoms and/or tested
positive for COVID-19. This document is available at www.osha.gov/coronavirus/ets/ibr.
Regulatory Text--Sec. 1910.502(l)(6)
CDC's Return to Work Healthcare Guidance (2021): These guidelines
provide guidance for occupational and public health professionals to
develop policies to determine when an employee can return to work after
quarantine and/or isolation in healthcare settings. This document is
available at www.osha.gov/coronavirus/ets/ibr.
Regulatory Text--Sec. 1910.502(b)
EPA's List N (2021): The products listed in this list meet EPA's
criteria for use against SARS-CoV-2 (COVID-19) to clean and disinfect
surfaces. This document is available at www.osha.gov/coronavirus/ets/ibr.
Copies of the consensus standards are available for purchase from
the issuing organizations at the addresses or through the other contact
information listed in Sec. 1910.509. The CDC and EPA documents are
available at no cost through the contact information listed above. In
addition, in accordance with Sec. 1910.509(a)(1), these standards are
available for inspection at any Regional Office of the Occupational
Safety and Health Administration (OSHA), or at the OSHA Docket Office,
U.S. Department of Labor, 200 Constitution Avenue NW, Room N-3508,
Washington, DC 20210; telephone: 202-693-2350 (TTY number:
877-889-5627). Due to copyright issues, OSHA cannot post consensus
standards on the OSHA website or through www.regulations.gov.
List of Subjects in 29 CFR Part 1910
COVID-19, Disease, Health facilities, Health, Healthcare,
Incorporation by reference, Occupational health and safety, Public
health, Quarantine, Reporting and recordkeeping requirements,
Respirators, SARS-CoV-2, Telework, Vaccines, Viruses.
Authority and Signature
James S. Frederick, Acting Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Avenue NW, Washington, DC 20210, authorized the
preparation of this document pursuant to the following authorities:
Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, 657); Secretary of Labor's Order 8-2020 (85 FR
58393 (Sept. 18, 2020)); 29 CFR part 1911; and 5 U.S.C. 553.
James S. Frederick,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
For the reasons set forth in the preamble, chapter XVII of title 29
of the Code of Federal Regulations is amended as follows:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS
0
1. Add subpart U to read as follows:
Subpart U--COVID-19 Emergency Temporary Standard
Sec.
1910.502 Healthcare.
1910.504 Mini Respiratory Protection Program.
1910.505 Severability.
1910.509 Incorporation by Reference.
Authority: 29 U.S.C. 653, 655, and 657; Secretary of Labor's
Order No. 8-2020 (85 FR 58393); 29 CFR part 1911; and 5 U.S.C. 553.
Sec. 1910.502 Healthcare.
(a) Scope and application. (1) Except as otherwise provided in this
paragraph, this section applies to all settings where any employee
provides healthcare services or healthcare support services.
(2) This section does not apply to the following:
(i) The provision of first aid by an employee who is not a licensed
healthcare provider;
(ii) The dispensing of prescriptions by pharmacists in retail
settings;
(iii) Non-hospital ambulatory care settings where all non-employees
are screened prior to entry and people with suspected or confirmed
COVID-19 are not permitted to enter those settings;
(iv) Well-defined hospital ambulatory care settings where all
employees are fully vaccinated and all non-employees are screened prior
to entry and people with suspected or confirmed COVID-19 are not
permitted to enter those settings;
(v) Home healthcare settings where all employees are fully
vaccinated and all non-employees are screened prior to entry and people
with suspected or confirmed COVID-19 are not present;
(vi) Healthcare support services not performed in a healthcare
setting (e.g., off-site laundry, off-site medical billing); or
(vii) Telehealth services performed outside of a setting where
direct patient care occurs.
Note to paragraph (a)(2). OSHA does not intend to preclude the
employers of employees who are unable to be vaccinated from the
scope exemption in paragraphs (a)(2)(iv) and (v) of this section.
Under various anti-discrimination laws, workers who cannot be
vaccinated because of medical conditions, such as allergies to
vaccine ingredients, or certain religious beliefs may ask for a
reasonable accommodation from their employer. Accordingly, where an
employer reasonably accommodates an employee who is unable to be
vaccinated in a manner that does not expose the employee to COVID-19
hazards (e.g., telework, working in isolation), that employer may be
within the scope exemption in paragraphs (a)(2)(iv) and (v) of this
section.
(3)(i) Where a healthcare setting is embedded within a non-
healthcare setting (e.g., medical clinic in a manufacturing facility,
walk-in clinic in a retail setting), this section applies only to the
embedded healthcare setting and not to the remainder of the physical
location.
(ii) Where emergency responders or other licensed healthcare
providers enter a non-healthcare setting to provide healthcare
services, this section applies only to the provision of the healthcare
services by that employee.
(4) In well-defined areas where there is no reasonable expectation
that any person with suspected or confirmed COVID-19 will be present,
paragraphs (f), (h), and (i) of this section do not apply to employees
who are fully vaccinated.
Note 1 to paragraph (a). Nothing in this section is intended to
limit state or local government mandates or guidance (e.g.,
executive order, health department order) that go beyond the
requirements of and are not inconsistent with this section.
Note 2 to paragraph (a): Employers are encouraged to follow
public health guidance from the Centers for Disease Control and
Prevention (CDC) even when not required by this section.
(b) Definitions. The following definitions apply to this section:
Aerosol-generating procedure means a medical procedure that
generates aerosols that can be infectious and are of respirable size.
For the purposes of this section, only the following medical procedures
are considered aerosol-generating procedures: Open suctioning of
airways; sputum induction; cardiopulmonary resuscitation; endotracheal
intubation and extubation; non-invasive ventilation (e.g., BiPAP,
CPAP); bronchoscopy; manual ventilation; medical/surgical/postmortem
procedures using oscillating bone saws; and dental procedures
involving: Ultrasonic scalers; high-speed dental handpieces; air/water
syringes; air polishing; and air abrasion.
Airborne infection isolation room (AIIR) means a dedicated negative
pressure patient-care room, with special air handling capability, which
is used to isolate persons with a suspected or confirmed airborne-
transmissible infectious disease. AIIRs include both permanent rooms
and temporary structures (e.g., a booth, tent or other enclosure
designed to operate under negative pressure).
Ambulatory care means healthcare services performed on an
outpatient basis, without admission to a hospital or other facility. It
is provided in settings such as: Offices of physicians and other health
care professionals; hospital outpatient departments; ambulatory
surgical centers; specialty clinics or centers (e.g., dialysis,
infusion, medical imaging); and urgent care clinics. Ambulatory care
does not include home healthcare settings for the purposes of this
section.
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, or designee.
Clean/cleaning means the removal of dirt and impurities, including
germs, from surfaces using soap and water or other cleaning agents.
Cleaning alone reduces germs on surfaces by removing contaminants and
may also weaken or damage some of the virus particles, which decreases
risk of infection from surfaces.
Close contact means being within 6 feet of any other person for a
cumulative total of 15 minutes or more over a 24-hour period during
that person's potential period of transmission. The potential
transmission period runs from 2 days before the person felt sick (or,
for asymptomatic people, 2 days prior to test specimen collection)
until the time the person is isolated.
Common areas means indoor or outdoor locations under the control of
the employer that more than one person may use or where people
congregate (e.g., building lobbies, reception areas, waiting rooms,
restrooms, break rooms, eating areas, conference rooms).
COVID-19 (Coronavirus Disease 2019) means the respiratory disease
caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
For clarity and ease of reference, this section refers to ``COVID-19''
when describing exposures or potential exposures to SARS-CoV-2.
COVID-19 positive and confirmed COVID-19 refer to a person who has
a confirmed positive test for, or who has been diagnosed by a licensed
healthcare provider with, COVID-19.
COVID-19 symptoms mean the following: Fever or chills; cough;
shortness of breath or difficulty breathing; fatigue; muscle or body
aches; headache; new loss of taste or smell; sore throat; congestion or
runny nose; nausea or vomiting; diarrhea.
COVID-19 test means a test for SARS-CoV-2 that is:
(i) Cleared or approved by the U.S. Food and Drug Administration
(FDA) or is authorized by an Emergency Use Authorization (EUA) from the
FDA to diagnose current infection with the SARS-CoV-2 virus; and
(ii) Administered in accordance with the FDA clearance or approval
or the FDA EUA as applicable.
Direct patient care means hands-on, face-to-face contact with
patients for the purpose of diagnosis, treatment, and monitoring.
Disinfect/disinfection means using an EPA-registered, hospital-
grade disinfectant on EPA's ``List N'' (incorporated by reference,
Sec. 1910.509), in accordance with manufacturers' instructions to kill
germs on surfaces.
Elastomeric respirator means a tight-fitting respirator with a
facepiece that is made of synthetic or rubber material that permits it
to be disinfected, cleaned, and reused according to manufacturer's
instructions. It is equipped with a replaceable cartridge(s),
canister(s), or filter(s).
Facemask means a surgical, medical procedure, dental, or isolation
mask that is FDA-cleared, authorized by an FDA EUA, or offered or
distributed as described in an FDA enforcement policy. Facemasks may
also be referred to as ``medical procedure masks.''
Face shield means a device, typically made of clear plastic, that:
(i) Is certified to ANSI/ISEA Z87.1 (incorporated by reference,
Sec. 1910.509); or
(ii) Covers the wearer's eyes, nose, and mouth to protect from
splashes, sprays, and spatter of body fluids, wraps around the sides of
the wearer's face (i.e., temple-to-temple), and extends below the
wearer's chin.
Filtering facepiece respirator means a negative pressure
particulate respirator with a non-replaceable filter as an integral
part of the facepiece or with the entire facepiece composed of the non-
replaceable filtering medium.
Fully vaccinated means 2 weeks or more following the final dose of
a COVID-19 vaccine.
Hand hygiene means the cleaning and/or disinfecting of one's hands
by using standard handwashing methods with soap and running water or an
alcohol-based hand rub that is at least 60% alcohol.
Healthcare services mean services that are provided to individuals
by professional healthcare practitioners (e.g., doctors, nurses,
emergency medical personnel, oral health professionals) for the purpose
of promoting, maintaining, monitoring, or restoring health. Healthcare
services are delivered through various means including:
Hospitalization, long-term care, ambulatory care, home health and
hospice care, emergency medical response, and patient transport. For
the purposes of this section, healthcare services include autopsies.
Healthcare support services mean services that facilitate the
provision of healthcare services. Healthcare support services include
patient intake/admission, patient food services, equipment and facility
maintenance, housekeeping services, healthcare laundry services,
medical waste handling services, and medical equipment cleaning/
reprocessing services.
High-touch surfaces and equipment means any surface or piece of
equipment that is repeatedly touched by more than one person (e.g.,
doorknobs, light switches, countertops, handles, desks, tables, phones,
keyboards, tools, toilets, faucets, sinks, credit card terminals,
touchscreen-enabled devices).
Physical location means a site (including outdoor and indoor areas,
a structure, or a group of structures) or an area within a site where
work or any work-related activity (e.g., taking breaks, going to the
restroom, eating, entering, or exiting work) occurs. A physical
location includes the entirety of any space associated with the site
(e.g., workstations, hallways, stairwells, breakrooms, bathrooms,
elevators) and any other space that an employee might occupy in
arriving, working, or leaving.
Powered air-purifying respirator (PAPR) means an air-purifying
respirator that uses a blower to force the ambient air through air-
purifying elements to the inlet covering.
Respirator means a type of personal protective equipment (PPE) that
is certified by NIOSH under 42 CFR part 84 or is authorized under an
EUA by the FDA. Respirators protect against airborne hazards by
removing specific air contaminants from the ambient (surrounding) air
or by supplying breathable air from a safe source. Common types of
respirators include filtering facepiece respirators, elastomeric
respirators, and PAPRs. Face coverings, facemasks, and face shields are
not respirators.
Screen means asking questions to determine whether a person is
COVID-19 positive or has symptoms of COVID-19.
Surgical mask means a mask that covers the user's nose and mouth
and provides a physical barrier to fluids and particulate materials.
The mask meets certain fluid barrier protection standards and Class I
or Class II flammability tests. Surgical masks are generally regulated
by FDA as Class II devices under 21 CFR 878.4040--Surgical apparel.
Vaccine means a biological product authorized or licensed by the
FDA to prevent or provide protection against COVID-19, whether the
substance is administered through a single dose or a series of doses.
Workplace means a physical location (e.g., fixed, mobile) where the
employer's work or operations are performed.
(c) COVID-19 plan. (1) The employer must develop and implement a
COVID-19 plan for each workplace. If the employer has multiple
workplaces that are substantially similar, its COVID-19 plan may be
developed by workplace type rather than by individual workplace so long
as all required site-specific information is included in the plan.
Note to paragraph (c)(1). For those employers who do not already
have a COVID-19 plan in place, OSHA's website contains significant
compliance assistance materials, including a model plan.
(2) If the employer has more than 10 employees, the COVID-19 plan
must be written.
(3) The employer must designate one or more workplace COVID-19
safety coordinators to implement and monitor the COVID-19 plan
developed under this section. The COVID-19 safety coordinator(s) must
be knowledgeable in infection control principles and
practices as they apply to the workplace and employee job operations.
The identity of the safety coordinator(s) must be documented in any
written COVID-19 plan. The safety coordinator(s) must have the
authority to ensure compliance with all aspects of the COVID-19 plan.
(4)(i) The employer must conduct a workplace-specific hazard
assessment to identify potential workplace hazards related to COVID-19.
(ii) In order for an employer to be exempt from providing controls
in a well-defined area under paragraph (a)(4) of this section based on
employees' fully vaccinated status, the COVID-19 plan must include
policies and procedures to determine employees' vaccination status.
(5) The employer must seek the input and involvement of non-
managerial employees and their representatives, if any, in the hazard
assessment and the development and implementation of the COVID-19 plan.
(6) The employer must monitor each workplace to ensure the ongoing
effectiveness of the COVID-19 plan and update it as needed.
(7) The COVID-19 plan must address the hazards identified by the
assessment required by paragraph (c)(4) of this section, and include
policies and procedures to:
(i) Minimize the risk of transmission of COVID-19 for each
employee, as required by paragraphs (d) through (n) of this section;
Note to paragraph (c)(7)(i). Although the employer's COVID-19
plan must account for the potential COVID-19 exposures to each
employee, the plan can do so generally and need not address each
employee individually.
(ii) Effectively communicate and coordinate with other employers:
(A) When employees of different employers share the same physical
location, each employer must effectively communicate its COVID-19 plan
to all other employers, coordinate to ensure that each of its employees
is protected as required by this section, and adjust its COVID-19 plan
to address any particular COVID-19 hazards presented by the other
employees. This requirement does not apply to delivery people,
messengers, and other employees who only enter a workplace briefly to
drop off or pick up items.
(B) An employer with one or more employees working in a physical
location controlled by another employer must notify the controlling
employer when those employees are exposed to conditions at that
location that do not meet the requirements of this section; and
(iii) Protect employees who in the course of their employment enter
into private residences or other physical locations controlled by a
person not covered by the OSH Act (e.g., homeowners, sole proprietors).
This must include procedures for employee withdrawal from that location
if those protections are inadequate.
Note to paragraph (c). The employer may include other policies,
procedures, or information necessary to comply with any applicable
federal, state, or local public health laws, standards, and
guidelines in their COVID-19 plan.
(d) Patient screening and management. In settings where direct
patient care is provided, the employer must:
(1) Limit and monitor points of entry to the setting. This
provision does not apply where emergency responders or other licensed
healthcare providers enter a non-healthcare setting to provide
healthcare services.
(2) Screen and triage all clients, patients, residents, delivery
people and other visitors, and other non-employees entering the
setting.
(3) Implement other applicable patient management strategies in
accordance with CDC's ``COVID-19 Infection Prevention and Control
Recommendations'' (incorporated by reference, Sec. 1910.509).
Note to paragraph (d). The employer is encouraged to use
telehealth services where available and appropriate in order to
limit the number of people entering the workplace.
(e) Standard and Transmission-Based Precautions. Employers must
develop and implement policies and procedures to adhere to Standard and
Transmission-Based Precautions in accordance with CDC's ``Guidelines
for Isolation Precautions'' (incorporated by reference, Sec.
1910.509).
(f) Personal protective equipment (PPE)--(1) Facemasks. (i)
Employers must provide, and ensure that employees wear, facemasks that
meet the definition in paragraph (b) of this section; and
(ii) The employer must ensure a facemask is worn by each employee
over the nose and mouth when indoors and when occupying a vehicle with
other people for work purposes. The employer must provide a sufficient
number of facemasks to each employee to comply with this paragraph and
must ensure that each employee changes them at least once per day,
whenever they are soiled or damaged, and more frequently as necessary
(e.g., patient care reasons).
(iii) The following are exceptions to the requirements for
facemasks in paragraph (f)(1)(ii) of this section:
(A) When an employee is alone in a room.
(B) While an employee is eating and drinking at the workplace,
provided each employee is at least 6 feet away from any other person,
or separated from other people by a physical barrier.
(C) When employees are wearing respiratory protection in accordance
with Sec. 1910.134 or paragraph (f) of this section.
(D) When it is important to see a person's mouth (e.g.,
communicating with an individual who is deaf or hard of hearing) and
the conditions do not permit a facemask that is constructed of clear
plastic (or includes a clear plastic window). In such situations, the
employer must ensure that each employee wears an alternative to protect
the employee, such as a face shield, if the conditions permit it.
(E) When employees cannot wear facemasks due to a medical
necessity, medical condition, or disability as defined in the Americans
with Disabilities Act (42 U.S.C. 12101 et seq.), or due to a religious
belief. Exceptions must be provided for a narrow subset of persons with
a disability who cannot wear a facemask or cannot safely wear a
facemask, because of the disability, as defined in the Americans with
Disabilities Act (42 U.S.C. 12101 et seq.), including a person who
cannot independently remove the facemask. The remaining portion of the
subset who cannot wear a facemask may be exempted on a case-by-case
basis as required by the Americans with Disabilities Act and other
applicable laws. In all such situations, the employer must ensure that
any such employee wears a face shield for the protection of the
employee, if their condition or disability permits it. Accommodations
may also need to be made for religious beliefs consistent with Title
VII of the Civil Rights Act.
(F) When the employer can demonstrate that the use of a facemask
presents a hazard to an employee of serious injury or death (e.g., arc
flash, heat stress, interfering with the safe operation of equipment).
In such situations, the employer must ensure that each employee wears
an alternative to protect the employee, such as a face shield, if the
conditions permit it. Any employee not wearing a facemask must remain
at least 6 feet away from all other people unless the employer can
demonstrate it is not feasible. The employee must resume wearing a
facemask when not engaged in the
activity where the facemask presents a hazard.
Note to paragraph (f)(1)(iii)(F). With respect to paragraphs
(f)(1)(iii)(D) through (F) of this section, the employer may
determine that the use of face shields, without facemasks, in
certain settings is not appropriate due to other infection control
concerns.
(iv) Where a face shield is required to comply with this paragraph
or is otherwise required by the employer, the employer must ensure that
face shields are cleaned at least daily and are not damaged. When an
employee provides a face shield that meets the definition in paragraph
(b) of this section, the employer may allow the employee to use it and
is not required to reimburse the employee for that face shield.
(2) Respirators and other PPE for exposure to people with suspected
or confirmed COVID-19. When employees have exposure to a person with
suspected or confirmed COVID-19, the employer must provide:
(i) A respirator to each employee and ensure that it is provided
and used in accordance with Sec. 1910.134 and
(ii) Gloves, an isolation gown or protective clothing, and eye
protection to each employee and ensure that the PPE is used in
accordance with subpart I of this part.
Note to paragraph (f)(2). When there is a limited supply of
filtering facepiece respirators, employers may follow the CDC's
``Strategies for Optimizing the Supply of N95 Respirators''
(available at: https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html). Where possible, employers are
encouraged to select elastomeric respirators or PAPRs instead of
filtering facepiece respirators to prevent shortages and supply
chain disruption.
(3) Respirators and other PPE during aerosol-generating procedures.
For aerosol-generating procedures performed on a person with suspected
or confirmed COVID-19, the employer must provide:
(i) A respirator to each employee and ensure that it is provided
and used in accordance with Sec. 1910.134; and
(ii) Gloves, an isolation gown or protective clothing, and eye
protection to each employee and ensure that the PPE is used in
accordance with subpart I of this part.
Note 1 to paragraph (f)(3). For aerosol-generating procedures on
a person suspected or confirmed with COVID-19, employers are
encouraged to select elastomeric respirators or PAPRs instead of
filtering facepiece respirators.
Note 2 to paragraph (f)(3). Additional requirements specific to
aerosol-generating procedures on people with suspected or confirmed
COVID-19 are contained in paragraph (g) of this section.
(4) Use of respirators when not required. (i) The employer may
provide a respirator to the employee instead of a facemask as required
by paragraph (f)(1) of this section. In such circumstances, the
employer must comply with Sec. 1910.504.
(ii) Where the employer provides the employee with a facemask as
required by paragraph (f)(1) of this section, the employer must permit
the employee to wear their own respirator instead of a facemask. In
such circumstances, the employer must also comply with Sec. 1910.504.
(5) Respirators and other PPE based on Standard and Transmission-
Based Precautions. The employer must provide protective clothing and
equipment (e.g., respirators, gloves, gowns, goggles, face shields) to
each employee in accordance with Standard and Transmission-Based
Precautions in healthcare settings in accordance with CDC's
``Guidelines for Isolation Precautions'' (incorporated by reference,
Sec. 1910.509) and ensure that the protective clothing and equipment
is used in accordance with subpart I of this part.
(g) Aerosol-generating procedures on a person with suspected or
confirmed COVID-19. When an aerosol-generating procedure is performed
on a person with suspected or confirmed COVID-19:
(1) The employer must limit the number of employees present during
the procedure to only those essential for patient care and procedure
support.
(2) The employer must ensure that the procedure is performed in an
existing AIIR, if available.
(3) After the procedure is completed, the employer must clean and
disinfect the surfaces and equipment in the room or area where the
procedure was performed.
Note to paragraph (g). Respirators and other PPE requirements
during aerosol-generating procedures are contained in paragraph
(f)(3) of this section.
(h) Physical distancing. (1) The employer must ensure that each
employee is separated from all other people by at least 6 feet when
indoors unless the employer can demonstrate that such physical
distancing is not feasible for a specific activity (e.g., hands-on
medical care). This provision does not apply to momentary exposure
while people are in movement (e.g., passing in hallways or aisles).
(2) When the employer establishes it is not feasible for an
employee to maintain a distance of at least 6 feet from all other
people, the employer must ensure that the employee is as far apart from
all other people as feasible.
Note to paragraph (h). Physical distancing can include methods
such as: Telehealth; telework or other remote work arrangements;
reducing the number of people, including non-employees, in an area
at one time; visual cues such as signs and floor markings to
indicate where employees and others should be located or their
direction and path of travel; staggered arrival, departure, work,
and break times; and adjusted work processes or procedures to allow
greater distance between employees.
(i) Physical barriers. At each fixed work location outside of
direct patient care areas (e.g., entryway/lobby, check-in desks,
triage, hospital pharmacy windows, bill payment) where each employee is
not separated from all other people by at least 6 feet of distance, the
employer must install cleanable or disposable solid barriers, except
where the employer can demonstrate it is not feasible. The barrier must
be sized (e.g., height and width) and located to block face-to-face
pathways between individuals based on where each person would normally
stand or sit. The barrier may have a pass-through space at the bottom
for objects and merchandise.
Note to paragraph (i). Physical barriers are not required in
direct patient care areas or resident rooms.
(j) Cleaning and disinfection. (1) In patient care areas, resident
rooms, and for medical devices and equipment, the employer must follow
standard practices for cleaning and disinfection of surfaces and
equipment in accordance with CDC's ``COVID-19 Infection Prevention and
Control Recommendations'' and CDC's ``Guidelines for Environmental
Infection Control,'' pp. 86-103, 147-149 (both incorporated by
reference, Sec. 1910.509).
(2) In all other areas, the employer must:
(i) Clean high-touch surfaces and equipment at least once a day,
following manufacturers' instructions for application of cleaners; and
(ii) When the employer is aware that a person who is COVID-19
positive has been in the workplace within the last 24 hours, clean and
disinfect, in accordance with CDC's ``Cleaning and Disinfecting
Guidance'' (incorporated by reference, Sec. 1910.509), any areas,
materials, and equipment under the employer's control that have likely
been contaminated by the person who is COVID-19 positive (e.g., rooms
they occupied, items they touched).
(3) The employer must provide alcohol-based hand rub that is at
least 60% alcohol or provide readily accessible hand washing
facilities.
(k) Ventilation. (1) Employers who own or control buildings or
structures with an existing heating, ventilation, and air conditioning
(HVAC) system(s) must ensure that:
(i) The HVAC system(s) is used in accordance with the HVAC
manufacturer's instructions and the design specifications of the HVAC
system(s);
(ii) The amount of outside air circulated through its HVAC
system(s) and the number of air changes per hour are maximized to the
extent appropriate;
(iii) All air filters are rated Minimum Efficiency Reporting Value
(MERV) 13 or higher, if compatible with the HVAC system(s). If MERV-13
or higher filters are not compatible with the HVAC system(s), employers
must use filters with the highest compatible filtering efficiency for
the HVAC system(s);
(iv) All air filters are maintained and replaced as necessary to
ensure the proper function and performance of the HVAC system(s); and
(v) All intake ports that provide outside air to the HVAC system(s)
are cleaned, maintained, and cleared of any debris that may affect the
function and performance of the HVAC system(s).
(2) Where the employer has an existing AIIR, the employer must
maintain and operate it in accordance with its design and construction
criteria.
Note 1 to paragraph (k). This section does not require
installation of new HVAC systems or AIIRs to replace or augment
functioning systems.
Note 2 to paragraph (k). In addition to the requirements for
existing HVAC systems and AIIRs, all employers should also consider
other measures to improve ventilation in accordance with ``CDC's
Ventilation Guidance,'' (available at www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html) (e.g., opening windows and doors).
This could include maximizing ventilation in buildings without HVAC
systems or in vehicles.
(l) Health screening and medical management--(1) Screening. (i) The
employer must screen each employee before each work day and each shift.
Screening may be conducted by asking employees to self-monitor before
reporting to work or may be conducted in-person by the employer.
(ii) If a COVID-19 test is required by the employer for screening
purposes, the employer must provide the test to each employee at no
cost to the employee.
(2) Employee notification to employer of COVID-19 illness or
symptoms. The employer must require each employee to promptly notify
the employer when the employee:
(i) Is COVID-19 positive (i.e., confirmed positive test for, or has
been diagnosed by a licensed healthcare provider with, COVID-19); or
(ii) Has been told by a licensed healthcare provider that they are
suspected to have COVID-19; or
(iii) Is experiencing recent loss of taste and/or smell with no
other explanation; or
(iv) Is experiencing both fever (>=100.4 [deg]F) and new
unexplained cough associated with shortness of breath.
(3) Employer notification to employees of COVID-19 exposure in the
workplace.
(i) Except as provided for in paragraph (l)(3)(iii) of this
section, when the employer is notified that a person who has been in
the workplace(s) (including employees, clients, patients, residents,
vendors, contractors, customers, delivery people and other visitors, or
other non-employees) is COVID-19 positive, the employer must, within 24
hours:
(A) Notify each employee who was not wearing a respirator and any
other required PPE and has been in close contact with that person in
the workplace. The notification must state the fact that the employee
was in close contact with someone with COVID-19 along with the date(s)
that contact occurred.
(B) Notify all other employees who were not wearing a respirator
and any other required PPE and worked in a well-defined portion of a
workplace (e.g., a particular floor) in which that person was present
during the potential transmission period. The potential transmission
period runs from 2 days before the person felt sick (or, for
asymptomatic people, 2 days prior to test specimen collection) until
the time the person is isolated. The notification must specify the
date(s) the person with COVID-19 was in the workplace during the
potential transmission period.
(C) Notify other employers whose employees were not wearing
respirators and any other required PPE and have been in close contact
with that person, or worked in a well-defined portion of a workplace
(e.g., a particular floor) in which that person was present, during the
potential transmission period. The potential transmission period runs
from 2 days before the person felt sick (or, for asymptomatic people, 2
days prior to test specimen collection) until the time the person is
isolated. The notification must specify the date(s) the person with
COVID-19 was in the workplace during the potential transmission period
and the location(s) where the person with COVID-19 was in the
workplace.
(ii) The notifications required by paragraph (l)(3)(i) of this
section must not include any employee's name, contact information
(e.g., phone number, email address), or occupation.
(iii) The notification provisions are not triggered by the presence
of a patient with confirmed COVID-19 in a workplace where services are
normally provided to suspected or confirmed COVID-19 patients (e.g.,
emergency rooms, urgent care facilities, COVID-19 testing sites, COVID-
19 wards in hospitals).
(4) Medical removal from the workplace. (i) If the employer knows
an employee meets the criteria listed in paragraph (l)(2)(i) of this
section, then the employer must immediately remove that employee and
keep the employee removed until they meet the return to work criteria
in paragraph (l)(6) of this section.
(ii) If the employer knows an employee meets the criteria listed in
paragraphs (l)(2)(ii) through (iv) of this section, then the employer
must immediately remove that employee and either:
(A) Keep the employee removed until they meet the return to work
criteria in paragraph (l)(6) of this section; or
(B) Keep the employee removed and provide a COVID-19 polymerase
chain reaction (PCR) test at no cost to the employee.
(1) If the test results are negative, the employee may return to
work immediately.
(2) If the test results are positive, the employer must comply with
paragraph (l)(4)(i) of this section.
(3) If the employee refuses to take the test, the employer must
continue to keep the employee removed from the workplace consistent
with paragraph (l)(4)(ii)(A) of this section, but the employer is not
obligated to provide medical removal protection benefits in accordance
with paragraph (l)(5)(iii) of this section. Absent undue hardship,
employers must make reasonable accommodations for employees who cannot
take the test for religious or disability-related medical reasons.
Note to paragraph (l)(4)(ii). This partial symptom list in
paragraphs (l)(2)(iii) and (l)(2)(iv) of this section informs the
employer of the minimum requirements for compliance. The full list
of COVID-19 symptoms provided by CDC includes additional symptoms
not listed in paragraphs (l)(2)(iii) through (iv) of this section.
Employers may choose to remove or test employees with additional
symptoms from the CDC list, or refer the employees to a healthcare
provider.
(iii)(A) If the employer is required to notify the employee of
close contact in
the workplace to a person who is COVID-19 positive in accordance with
paragraph (l)(3)(i)(A) of this section, then the employer must
immediately remove that employee and either:
(1) Keep the employee removed for 14 days; or
(2) Keep the employee removed and provide a COVID-19 test at least
five days after the exposure at no cost to the employee.
(i) If the test results are negative, the employee may return to
work after seven days following exposure.
(ii) If the test results are positive, the employer must comply
with paragraph (l)(4)(i) of this section.
(iii) If the employee refuses to take the test, the employer must
continue to keep the employee removed from the workplace consistent
with paragraph (l)(4)(iii)(A)(1) of this section, but the employer is
not obligated to provide medical removal protection benefits in
accordance with paragraph (l)(5)(iii) of this section. Absent undue
hardship, employers must make reasonable accommodations for employees
who cannot take the test for religious or disability-related medical
reasons, consistent with applicable non-discrimination laws.
(B) Employers are not required to remove any employee who would
otherwise be required to be removed under paragraph (i)(4)(iii)(A) of
this section if the employee does not experience the symptoms in
paragraph (l)(2)(iii) or (iv) of this section and has:
(1) Been fully vaccinated against COVID-19 (i.e., 2 weeks or more
following the final dose); or
(2) Had COVID-19 and recovered within the past 3 months.
(iv) Any time an employee is required to be removed from the
workplace for any reason under paragraph (l)(4) of this section, the
employer may require the employee to work remotely or in isolation if
suitable work is available.
(5) Medical removal protection benefits. (i) Employers with 10 or
fewer employees on the effective date of this section are not required
to comply with paragraphs (l)(5)(iii) through (iv) of this section.
(ii) When an employer allows an employee to work remotely or in
isolation in accordance with paragraph (l)(4)(iv) of this section, the
employer must continue to pay the employee the same regular pay and
benefits the employee would have received had the employee not been
absent from work, until the employee meets the return to work criteria
specified in paragraph (l)(4)(iii) or (l)(6) of this section.
(iii) When an employer removes an employee in accordance with
paragraph (l)(4) of this section:
(A) The employer must continue to provide the benefits to which the
employee is normally entitled and must also pay the employee the same
regular pay the employee would have received had the employee not been
absent from work, up to $1,400 per week, until the employee meets the
return to work criteria specified in paragraph (l)(4)(iii) or (l)(6) of
this section.
(B) For employers with fewer than 500 employees, the employer must
pay the employee up to the $1,400 per week cap but, beginning in the
third week of an employee's removal, the amount is reduced to only two-
thirds of the same regular pay the employee would have received had the
employee not been absent from work, up to $200 per day ($1,000 per week
in most cases).
(iv) The employer's payment obligation under paragraph (l)(5)(iii)
of this section is reduced by the amount of compensation that the
employee receives from any other source, such as a publicly or
employer-funded compensation program (e.g., paid sick leave,
administrative leave), for earnings lost during the period of removal
or any additional source of income the employee receives that is made
possible by virtue of the employee's removal.
(v) Whenever an employee returns to the workplace after a COVID-19-
related workplace removal, that employee must not suffer any adverse
action as a result of that removal from the workplace and must maintain
all employee rights and benefits, including the employee's right to
their former job status, as if the employee had not been removed.
(6) Return to work. The employer must make decisions regarding an
employee's return to work after a COVID-19-related workplace removal in
accordance with guidance from a licensed healthcare provider or CDC's
``Isolation Guidance'' (incorporated by reference, Sec. 1910.509); and
CDC's ``Return to Work Healthcare Guidance'' (incorporated by
reference, Sec. 1910.509).
Note to paragraph (l). OSHA recognizes that CDC's ``Strategies
to Mitigate Healthcare Personnel Staffing Shortages'' (available at
www.cdc.gov/coronavirus/2019-ncov/hcp/mitigating-staff-shortages.html) allows elimination of quarantine for certain
healthcare workers, but only as a last resort, if the workers'
absence would mean there are no longer enough staff to provide safe
patient care, specific other amelioration strategies have already
been tried, patients have been notified, and workers are utilizing
additional PPE at all times.
(m) Vaccination. The employer must support COVID-19 vaccination for
each employee by providing reasonable time and paid leave (e.g., paid
sick leave, administrative leave) to each employee for vaccination and
any side effects experienced following vaccination.
(n) Training. (1) The employer must ensure that each employee
receives training, in a language and at a literacy level the employee
understands, and so that the employee comprehends at least the
following:
(i) COVID-19, including how the disease is transmitted (including
pre-symptomatic and asymptomatic transmission), the importance of hand
hygiene to reduce the risk of spreading COVID-19 infections, ways to
reduce the risk of spreading COVID-19 through the proper covering of
the nose and mouth, the signs and symptoms of the disease, risk factors
for severe illness, and when to seek medical attention;
(ii) Employer-specific policies and procedures on patient screening
and management;
(iii) Tasks and situations in the workplace that could result in
COVID-19 infection;
(iv) Workplace-specific policies and procedures to prevent the
spread of COVID-19 that are applicable to the employee's duties (e.g.,
policies on Standard and Transmission-Based Precautions, physical
distancing, physical barriers, ventilation, aerosol-generating
procedures);
(v) Employer-specific multi-employer workplace agreements related
to infection control policies and procedures, the use of common areas,
and the use of shared equipment that affect employees at the workplace;
(vi) Employer-specific policies and procedures for PPE worn to
comply with this section, including:
(A) When PPE is required for protection against COVID-19;
(B) Limitations of PPE for protection against COVID-19;
(C) How to properly put on, wear, and take off PPE;
(D) How to properly care for, store, clean, maintain, and dispose
of PPE; and
(E) Any modifications to donning, doffing, cleaning, storage,
maintenance, and disposal procedures needed to address COVID-19 when
PPE is worn to address workplace hazards other than COVID-19;
(vii) Workplace-specific policies and procedures for cleaning and
disinfection;
(viii) Employer-specific policies and procedures on health
screening and medical management;
(ix) Available sick leave policies, any COVID-19-related benefits
to which the employee may be entitled under
applicable federal, state, or local laws, and other supportive policies
and practices (e.g., telework, flexible hours);
(x) The identity of the safety coordinator(s) specified in the
COVID-19 plan;
(xi) The requirements of this section; and
(xii) How the employee can obtain copies of this section and any
employer-specific policies and procedures developed under this section,
including the employer's written COVID-19 plan, if required.
Note to paragraph (n)(1). Employers may rely on training
completed prior to the effective date of this section to the extent
that it meets the relevant training requirements under this
paragraph.
(2) The employer must ensure that each employee receives additional
training whenever:
(i) Changes occur that affect the employee's risk of contracting
COVID-19 at work (e.g., new job tasks);
(ii) Policies or procedures are changed; or
(iii) There is an indication that the employee has not retained the
necessary understanding or skill.
(3) The employer must ensure that the training is overseen or
conducted by a person knowledgeable in the covered subject matter as it
relates to the employee's job duties.
(4) The employer must ensure that the training provides an
opportunity for interactive questions and answers with a person
knowledgeable in the covered subject matter as it relates to the
employee's job duties.
(o) Anti-Retaliation. (1) The employer must inform each employee
that:
(i) Employees have a right to the protections required by this
section; and
(ii) Employers are prohibited from discharging or in any manner
discriminating against any employee for exercising their right to the
protections required by this section, or for engaging in actions that
are required by this section.
(2) The employer must not discharge or in any manner discriminate
against any employee for exercising their right to the protections
required by this section, or for engaging in actions that are required
by this section.
Note to paragraph (o). In addition, section 11(c) of the OSH
Act also prohibits the employer from discriminating against an
employee for exercising rights under, or as a result of actions that
are required by, this section. That provision of the Act also
protects the employee who files a safety and health complaint, or
otherwise exercises any rights afforded by the OSH Act.
(p) Requirements implemented at no cost to employees. The
implementation of all requirements of this section, with the exception
of any employee self-monitoring conducted under paragraph (l)(1)(i) of
this section, must be at no cost to employees.
(q) Recordkeeping. (1) Small employer exclusion. Employers with 10
or fewer employees on the effective date of this section are not
required to comply with paragraph (q)(2) or (q)(3) of this section.
(2) Required records. Employers with more than 10 employees on the
effective date of this section must:
(i) Retain all versions of the COVID-19 plan implemented to comply
with this section while this section remains in effect.
(ii) Establish and maintain a COVID-19 log to record each instance
identified by the employer in which an employee is COVID-19 positive,
regardless of whether the instance is connected to exposure to COVID-19
at work.
(A) The COVID-19 log must contain, for each instance, the
employee's name, one form of contact information, occupation, location
where the employee worked, the date of the employee's last day at the
workplace, the date of the positive test for, or diagnosis of, COVID-
19, and the date the employee first had one or more COVID-19 symptoms,
if any were experienced.
(B) The information in the COVID-19 log must be recorded within 24
hours of the employer learning that the employee is COVID-19 positive
and must be maintained as though it is a confidential medical record
and must not be disclosed except as required by this ETS or other
federal law.
(C) The COVID-19 log must be maintained and preserved while this
section remains in effect.
Note to paragraph (q)(2)(ii): The COVID-19 log is intended to
assist employers with tracking and evaluating instances of employees
who are COVID-19 positive without regard to whether those employees
were infected at work. The tracking will help evaluate potential
workplace exposure to other employees.
(3) Availability of records. By the end of the next business day
after a request, the employer must provide, for examination and
copying:
(i) All versions of the written COVID-19 plan to all of the
following: Any employees, their personal representatives, and their
authorized representatives.
(ii) The individual COVID-19 log entry for a particular employee to
that employee and to anyone having written authorized consent of that
employee.
(iii) A version of the COVID-19 log that removes the names of
employees, contact information, and occupation, and only includes, for
each employee in the COVID-19 log, the location where the employee
worked, the last day that the employee was at the workplace before
removal, the date of that employee's positive test for, or diagnosis
of, COVID-19, and the date the employee first had one or more COVID-19
symptoms, if any were experienced, to all of the following: Any
employees, their personal representatives, and their authorized
representatives.
(iv) All records required to be maintained by this section to the
Assistant Secretary.
Note to paragraph (q). Employers must continue to record all
work-related confirmed cases of COVID-19 on their OSHA Forms 300,
300A, and 301, or the equivalent forms, if required to do so under
29 CFR part 1904.
(r) Reporting COVID-19 fatalities and hospitalizations to OSHA. (1)
The employer must report to OSHA:
(i) Each work-related COVID-19 fatality within 8 hours of the
employer learning about the fatality.
(ii) Each work-related COVID-19 in-patient hospitalization within
24 hours of the employer learning about the in-patient hospitalization.
(2) When reporting COVID-19 fatalities and in-patient
hospitalizations to OSHA in accordance with paragraph (r)(1) of this
section, the employer must follow the requirements in 29 CFR 1904.39,
except for 29 CFR 1904.39(a)(1) and (2) and (b)(6).
(s) Dates. (1) Effective date. This section is effective as of June
21, 2021.
(2) Compliance dates. (i) Employers must comply with all
requirements of this section, except for requirements in paragraphs
(i), (k), and (n) of this section by July 6, 2021.
(ii) Employers must comply with the requirements of this section in
paragraphs (i), (k), and (n) of this section by July 21, 2021.
Sec. 1910.504 Mini Respiratory Protection Program.
(a) Scope and application. This section applies only to respirator
use in accordance with Sec. 1910.502(f)(4).
(b) Definitions. The following definitions apply to this section:
COVID-19 (Coronavirus Disease 2019) means the respiratory disease
caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
For clarity and ease of reference, this section refers to ``COVID-19''
when describing exposures or potential exposures to SARS-CoV-2.
Elastomeric respirator means a tight-fitting respirator with a
facepiece that is made of synthetic or rubber material that permits it
to be disinfected, cleaned, and reused according to
manufacturer's instructions. It is equipped with a replaceable
cartridge(s), canister(s), or filter(s).
Filtering facepiece respirator means a negative-pressure
particulate respirator with a non-replaceable filter as an integral
part of the facepiece or with the entire facepiece composed of the non-
replaceable filtering medium.
Hand hygiene means the cleaning and/or disinfecting of one's hands
by using standard handwashing methods with soap and running water or an
alcohol-based hand rub that is at least 60% alcohol.
Respirator means a type of personal protective equipment (PPE) that
is certified by the National Institute for Occupational Safety and
Health (NIOSH) under 42 CFR part 84 or is authorized under an Emergency
Use Authorization (EUA) by the US Food and Drug Administration.
Respirators protect against airborne hazards by removing specific air
contaminants from the ambient (surrounding) air or by supplying
breathable air from a safe source. Common types of respirators include
filtering facepiece respirators, elastomeric respirators, and PAPRs.
Face coverings, facemasks, and face shields are not respirators.
Powered air-purifying respirator (PAPR) means an air-purifying
respirator that uses a blower to force the ambient air through air-
purifying elements to the inlet covering.
Tight-fitting respirator means a respirator in which the air
pressure inside the facepiece is negative during inhalation with
respect to the ambient air pressure outside the respirator (e.g.,
filtering facepiece).
User seal check means an action conducted by the respirator user to
determine if the respirator is properly seated to the face.
(c) Respirators provided by employees. Where employees provide and
use their own respirators, the employer must provide each employee with
the following notice: Respirators can be an effective method of
protection against COVID-19 hazards when properly selected and worn.
Respirator use is encouraged to provide an additional level of comfort
and protection for workers even in circumstances that do not require a
respirator to be used. However, if a respirator is used improperly or
not kept clean, the respirator itself can become a hazard to the
worker. If your employer allows you to provide and use your own
respirator, you need to take certain precautions to be sure that the
respirator itself does not present a hazard. You should do the
following:
(1) Read and follow all instructions provided by the manufacturer
on use, maintenance, cleaning and care, and warnings regarding the
respirator's limitations.
(2) Keep track of your respirator so that you do not mistakenly use
someone else's respirator.
(3) Do not wear your respirator where other workplace hazards
(e.g., chemical exposures) require use of a respirator. In such cases,
your employer must provide you with a respirator that is used in
accordance with OSHA's respiratory protection standard (29 CFR
1910.134). For more information about using a respirator, see OSHA's
respiratory protection safety and health topics page (https://www.osha.gov/respiratory-protection).
(d) Respirators provided by employers. Where employers provide
respirators to their employees, the employer must comply with the
following requirements:
(1) Training. The employer must ensure that each employee wearing a
respirator receives training prior to first use and if they change the
type of respirator, in a language and at a literacy level the employee
understands, and comprehends at least the following:
(i) How to inspect, put on and remove, and use a respirator;
(ii) The limitations and capabilities of the respirator,
particularly when the respirator has not been fit tested;
(iii) Procedures and schedules for storing, maintaining, and
inspecting respirators;
(iv) How to perform a user seal check as described in paragraph
(d)(2) of this section; and
(v) How to recognize medical signs and symptoms that may limit or
prevent the effective use of respirators and what to do if the employee
experiences signs and symptoms.
(2) User seal check. (i) The employer must ensure that each
employee who uses a tight-fitting respirator performs a user seal check
to ensure that the respirator is properly seated to the face each time
the respirator is put on. Acceptable methods of user seal checks
include:
(A) Positive pressure user seal check (i.e., blow air out). Once
you have conducted proper hand hygiene and properly donned the
respirator, place your hands over the facepiece, covering as much
surface area as possible. Exhale gently into the facepiece. The face
fit is considered satisfactory if a slight positive pressure is being
built up inside the facepiece without any evidence of outward leakage
of air at the seal. Examples of evidence that it is leaking could be
the feeling of air movement on your face along the seal of the
facepiece, fogging of your glasses, or a lack of pressure being built
up inside the facepiece. If the particulate respirator has an
exhalation valve, then performing a positive pressure check may not be
possible unless the user can cover the exhalation valve. In such cases,
a negative pressure check must be performed.
(B) Negative pressure user seal check (i.e., suck air in). Once you
have conducted proper hand hygiene and properly donned the respirator,
cover the filter surface with your hands as much as possible and then
inhale. The facepiece should collapse on your face and you should not
feel air passing between your face and the facepiece.
(ii) The employer must ensure that each employee corrects any
problems discovered during the user seal check. In the case of either
type of user seal check (positive or negative), if air leaks around the
nose, use both hands to readjust how the respirator sits on your face
or adjust the nosepiece, if applicable. Readjust the straps along the
sides of your head until a proper seal is achieved.
Note to paragraph (d)(2). When employees are required to wear a
respirator and a problem with the seal check arises due to
interference with the seal by an employee's facial hair, employers
may provide a different type of respirator to accommodate employees
who cannot trim or cut facial hair due to religious belief.
(3) Reuse of respirators. (i) The employer must ensure that a
filtering facepiece respirator used by a particular employee is only
reused by that employee, and only when:
(A) The respirator is not visibly soiled or damaged;
(B) The respirator has been stored in a breathable storage
container (e.g., paper bag) for at least five calendar days between use
and has been kept away from water or moisture;
(C) The employee does a visual check in adequate lighting for
damage to the respirator's fabric or seal;
(D) The employee successfully completes a user seal check as
described in paragraph (d)(2) of this section;
(E) The employee uses proper hand hygiene before putting the
respirator on and conducting the user seal check; and
(F) The respirator has not been worn more than five days total.
Note to paragraph (d)(3)(i). The reuse of single-use
respirators (e.g., filtering facepiece respirators) is discouraged.
(ii) The employer must ensure that an elastomeric respirator or
PAPR is only reused when:
(A) The respirator is not damaged;
(B) The respirator is cleaned and disinfected as often as necessary
to be maintained in a sanitary condition in accordance with Sec.
1910.134, Appendix B-2; and
(C) A change schedule is implemented for cartridges, canisters, or
filters.
(4) Discontinuing use of respirators. Employers must require
employees to discontinue use of a respirator when either the employee
or a supervisor reports medical signs or symptoms (e.g., shortness of
breath, coughing, wheezing, chest pain, any other symptoms related to
lung problems, cardiovascular symptoms) that are related to ability to
use a respirator. Any employee who previously had a medical evaluation
and was determined to not be medically fit to wear a respirator must
not be provided with a respirator under this standard unless they are
re-evaluated and medically cleared to use a respirator.
(e) Effective date. This section is effective as of June 21, 2021.
Sec. 1910.505 Severability.
Each section of this subpart U, and each provision within those
sections, is separate and severable from the other sections and
provisions. If any provision of this subpart is held to be invalid or
unenforceable on its face, or as applied to any person, entity, or
circumstance, or is stayed or enjoined, that provision shall be
construed so as to continue to give the maximum effect to the provision
permitted by law, unless such holding shall be one of utter invalidity
or unenforceability, in which event the provision shall be severable
from this subpart and shall not affect the remainder of the subpart.
Sec. 1910.509 Incorporation by Reference.
(a)(1) The material listed in this section is incorporated by
reference into this subpart with the approval of the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
To enforce any edition other than that specified in this section, OSHA
must publish a document in the Federal Register and the material must
be available to the public. All approved material is available for
inspection at any Regional Office of the Occupational Safety and Health
Administration (OSHA), or at the OSHA Docket Office, U.S. Department of
Labor, 200 Constitution Avenue NW, Room N-3508, Washington, DC 20210;
telephone: 202-693-2350 (TTY number: 877-889-5627). It is also
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of these
standards at NARA, email fedreg.legal@nara.gov, or go to
www.archives.gov/federal-register/cfr/ibr-locations.html.
(2) The material is available from the sources listed in this
section and as follows:
(i) The material listed in paragraphs (b) and (c) of this section
(CDC and EPA) is available at this permanent weblink hosted by OSHA:
www.osha.gov/coronavirus/ets/ibr.
(ii) The material listed in paragraph (d) of this section (ISEA) is
available from the American National Standards Institute (ANSI), 25
West 43rd Street, 4th Floor, New York, NY 10036; telephone: 212-642-
4900; fax: 212-398-0023; website: http://www.ansi.org.
(b) Centers for Disease Control and Prevention (CDC): 1600 Clifton
Road, Atlanta, GA 30329; websites: https://www.cdc.gov/, https://www.cdc.gov/coronavirus/2019-ncov/communication/guidance.html, and
https://www.cdc.gov/infectioncontrol/guidelines/.
(1) Cleaning and Disinfecting Guidance. COVID-19: Cleaning and
Disinfecting Your Facility; Every Day and When Someone is Sick, updated
April 5, 2021, IBR approved for Sec. 1910.502(j).
(2) COVID-19 Infection Prevention and Control Recommendations.
COVID-19: Interim Infection Prevention and Control Recommendations for
Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic, updated February 23, 2021, IBR approved for Sec. Sec.
1910.502(d) and (j).
(3) Guidelines for Isolation Precautions. 2007 Guideline for
Isolation Precautions: Preventing Transmission of Infectious Agents in
Healthcare Settings, updated July 2019, IBR approved for Sec. Sec.
1910.502(e) and (f).
(4) Guidelines for Environmental Infection Control. Guidelines for
Environmental Infection Control in Health-Care Facilities, updated July
2019, IBR approved for Sec. 1910.502(j).
(5) Isolation Guidance. COVID-19: Isolation If You Are Sick;
Separate yourself from others if you have COVID-19, updated February
18, 2021, IBR approved for Sec. 1910.502(l).
(6) Return to Work Healthcare Guidance. COVID-19: Return to Work
Criteria for Healthcare Personnel with SARS-CoV-2 Infection (Interim
Guidance), updated February 16, 2021, IBR approved for Sec.
1910.502(l).
(c) U.S. Environmental Protection Agency (EPA): 1200 Pennsylvania
Avenue NW, Washington, DC 20460; website: https://www.epa.gov/.
(1) List N. Pesticide Registration List N: Disinfectants for
Coronavirus (COVID-19), updated April 9, 2021, IBR approved for Sec.
1910.502(b).
(2) [Reserved]
(d) International Safety Equipment Association (ISEA): 1901 North
Moore Street, Suite 808, Arlington, VA 22209; website:
www.safetyequipment.org
(1) ANSI/ISEA Z87.1-2010, American National Standard for
Occupational and Educational Personal Eye and Face Protection Devices,
ANSI-approved April 13, 2010, IBR approved for Sec. 1910.502(b).
(2) ANSI/ISEA Z87.1-2015, American National Standard for
Occupational and Educational Personal Eye and Face Protection Devices,
ANSI-approved May 28, 2015, IBR approved for Sec. 1910.502(b).
(3) ANSI/ISEA Z87.1-2020, American National Standard for
Occupational and Educational Personal Eye and Face Protection Devices,
ANSI-approved March 11, 2020, IBR approved for Sec. 1910.502(b).
[FR Doc. 2021-12428 Filed 6-17-21; 4:15 pm]
BILLING CODE 4510-26-P
