[Federal Register Volume 87, Number 123 (Tuesday, June 28, 2022)]
[Proposed Rules]
[Pages 38343-38362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13696]


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DEPARTMENT OF LABOR

29 CFR Parts 1910 and 1926

[Docket No. OSHA-2018-0004]
RIN 1218-AD10


Advance Notice of Proposed Rule Making (ANPRM)--Blood Lead Level 
for Medical Removal

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Advance Notice of Proposed Rulemaking (ANPRM).

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SUMMARY: OSHA is considering rulemaking to revise its standards for 
occupational exposure to lead based on medical findings since the 
issuance of OSHA's lead standards that adverse health effects in adults 
can occur at Blood Lead Levels (BLLs) lower than the medical removal 
level (>=60 [mu]g/dL in general industry, >=50 [mu]g/dL in 
construction) and lower than the level required under current standards 
for an employee to return to their former job status (<40 [mu]g/dL).\1\ 
The agency is seeking input on reducing the current BLL triggers in the 
medical surveillance and medical removal protection provisions of the 
general industry and construction standards for lead. The agency is 
also seeking input about how current ancillary provisions in the lead 
standards can be modified to reduce worker BLLs.
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    \1\ OSHA's standard for lead in general industry expresses blood 
lead in units of [mu]g/100g of whole blood. The standard for lead in 
construction expresses blood lead in units of [mu]g/dL, which the 
agency explained is essentially equivalent to [mu]g/100g of whole 
blood (29 CFR 1926.62, Appendix A, II.B.3: Health Protection Goals 
of the Standard). For simplicity, this ANPRM expresses blood lead in 
units of [mu]g/dL throughout.

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DATES: Submit comments on or before August 29, 2022.

ADDRESSES: You may submit comments and attachments, identified by 
Docket No. OSHA-2018-0004, electronically at www.regulations.gov, which 
is the Federal e-Rulemaking Portal. Follow the instructions online for 
making electronic submissions.
    Instructions: All submissions must include the agency's name and 
the docket number for this ANPRM (Docket No. OSHA-2018-0004). When 
uploading multiple attachments into Regulations.gov, please number all 
of your attachments because www.regulations.gov will not automatically 
number the attachments. For example, Attachment 1_title of your 
document, Attachment 2_title of your document, Attachment 3_title of 
your document, etc. When submitting comments or recommendations on the 
issues that are raised in this ANPRM, commenters should explain their 
rationale and, if possible, provide data and information to support 
their comments or recommendations. Wherever possible, please indicate 
the title of the person providing the information and the type and 
number of employees at your worksite.
    All comments, including any personal information you provide, will 
be placed in the public docket without change and will be publicly 
available online at www.regulations.gov. Therefore, OSHA cautions 
commenters about submitting information they do not want to be 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-2018-0004 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 submissions, 
including copyrighted material, are available for inspection at 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 ANPRM by author name and publication 
year, when appropriate. This information can be used to search for a 
supporting document in the docket at https://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: 
    Press Inquiries: Contact Frank Meilinger, Director, Office of 
Communications, U.S. Department of Labor; telephone (202) 693-1999; 
email meilinger.francis2@dol.gov.
    General and technical information: Contact Andrew Levinson, Acting 
Director, Directorate of Standards and Guidance, U.S. Department of 
Labor; telephone (202) 693-1950; email Levinson.andrew@dol.gov.

SUPPLEMENTARY INFORMATION: The Supplementary Information section 
follows this outline:

Table of Contents

I. Background
    A. Events Leading to This Action
    B. Industry Profile Information
    C. Health Effects of Lead Exposure
II. Request for Input
    A. Blood Lead Triggers for Medical Removal Protection
    B. Medical Surveillance Provisions
    C. Permissible Exposure Limit (PEL)
    D. Personal Protective Equipment (PPE), Hygiene, and Training
    E. Safe Harbor Compliance Protocols
    F. Environmental Effects
    G. Duplicative, Overlapping, or Conflicting Rules
    H. Questions for Employers on Current Practices

I. Background

A. Events Leading to This Action

    OSHA's lead standard for general industry (29 CFR 1910.1025), 
adopted in 1978, established a permissible exposure limit (PEL) 
airborne concentration of 50 [mu]g/m\3\ averaged over an 8-hour period 
and was based on consideration of health effects, feasibility issues, 
and the goal to keep BLLs below 40 [mu]g/dL for the majority of workers 
occupationally exposed to lead (43 FR 54191). During approximately the 
same time-frame, the United States Congress enacted a law to provide 
Federal financial assistance to help cities and communities eliminate 
the causes of lead-based paint poisoning and detect and treat 
incidences of lead poisoning (Pub. L., 91-695; 42 U.S.C. Ch. 63). 
Additionally, the Consumer Products Safety Commission (CPSC) 
implemented regulations prohibiting lead from most consumer products 
and banned lead from residential paint (16 CFR 1303). The U.S. 
Environmental Protection Agency (EPA) and the U.S. Department of 
Housing and Urban Development (HUD) enacted rules to reduce human and 
environmental exposure to lead (24 CFR 35; 40 CFR 80; 40 CFR 745).
    In 1992, OSHA promulgated an interim final rule for lead exposure 
in construction (29 CFR 1926.62) as required by Title X of the Housing 
and Community Development Act of 1992 (102 Pub. L. 550). This rule 
amended Subpart D of 29 CFR part 1926 by adding a new section, 1926.62, 
that lowered the existing lead PEL in construction to 50 [mu]g/m\3\ and 
included ancillary provisions similar to those in the general industry 
lead standard. OSHA's general industry and construction standards 
contain medical removal provisions for workers whose BLLs exceed a 
certain level: in general industry, when a periodic and a follow-up 
blood test result show BLL >=60 [mu]g/dL, or an average of the last 
three blood lead tests show BLL >=50 [mu]g/dL; and in construction, 
when a periodic and a follow-up blood test result show BLL >=50 [mu]g/
dL. These workers must be temporarily removed to a job with exposures 
at or below the action level (58 FR 26590).
    In 1992, the U.S. Congress passed the Workers' Family Protection 
Act (29 U.S.C. 671a). The Act required the National Institute for 
Occupational Safety and Health (NIOSH) to report on take-home 
contamination from workplace chemicals and substances, including 
lead.\2\ NIOSH found take-home exposure to be a widespread problem 
(NIOSH, 1995). The report identified workplace measures that are 
effective in reducing take-home exposure such as changing clothes 
before going home and leaving soiled clothing at work for laundering, 
storing street clothes in areas separate from work clothes, showering 
before leaving work, and prohibiting removal of toxic substances or 
contaminated items from the workplace, in addition to citing the 
importance of primary prevention by limiting exposure in the workplace. 
NIOSH noted that preventing take-home exposure is critical because 
decontaminating homes and vehicles is not always effective.
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    \2\ Take-home lead contamination occurs when lead dust is 
transferred from the workplace on employees' skin, clothing, shoes, 
and other personal items to their vehicle and home. Take-home lead 
can be a chronic source of exposure for workers and exposures to 
household members (NIOSH 1995).
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    In 1996, OSHA implemented a Special Emphasis Program (SEP) for lead 
in construction (CPL 2.105) in response to documented elevated BLLs in 
construction workers. The SEP established a mechanism for programmed 
health inspections of construction sites where lead may be present. In 
2001, OSHA implemented a National Emphasis Program (NEP) for lead (CPL 
2-0.130). The NEP was implemented to direct OSHA's field inspection 
efforts to reduce occupational exposures to lead. This ongoing NEP 
includes general industry, construction, longshoring, and marine 
terminals. OSHA updated its NEP for lead in 2008 and expanded its 
targeting in 2013 to include indoor and outdoor firing ranges and 
recycling industries (OSHA, 2008; OSHA, 2013). In 2007, OSHA completed 
a Regulatory Flexibility Act Section 610 review and Executive Order 
12866 lookback review of 29 CFR 1926.62 Lead in Construction (OSHA, 
2007). The agency found that for the hazards associated with lead in 
the construction industry, a mandatory standard remains necessary to 
adequately protect employees. The lookback study also concluded that 
the lead in construction standard has not had negative economic impacts 
on business, including small businesses, and therefore remains 
economically feasible.
    Exposure to lead is associated with adverse health effects, 
including but not limited to effects on the reproductive, 
cardiovascular, neurological, respiratory, and immune systems. Since 
promulgation of OSHA's lead standards, extensive research has been 
published indicating adverse health effects in adults at lower levels 
than had been previously documented (see, e.g., AOEC 2007; NTP 2012; 
ATSDR 2020; ACGIH 2013; EPA 2013). A variety of public health and 
government organizations have developed recommendations or revisions to 
standards to more stringently limit occupational exposures to lead and 
manage the effects of exposure in exposed workers. In 2007, the 
Association of Occupational and Environmental Clinics (AOEC) published 
guidelines for medical management of lead exposed adults (with special 
emphasis on those exposed to lead at work). The recommendations 
included: clinical assessment with detailed medical, occupational, and 
environmental history, physical exam, BLL determination, and other labs 
(CBC, BUN, Creatinine, Urine Analysis, EP); medical surveillance with 
follow-up BLL; and medical management with evaluation of exposures and 
risk factors, family and social context, and consideration for 
potential removal from exposure (AOEC, 2007). In 2016, the American 
College of Occupational and Environmental Medicine (ACOEM) released a 
Position Statement on Workplace Lead Exposure recommending revisions to 
OSHA's AL and PEL; workplace hygiene requirements; medical surveillance 
and medical removal protection provisions; and introduction of surface 
lead dust requirements (ACOEM 2016, p. e371). The Department of Defense 
(DOD) commissioned the National Research Council (NRC) to conduct a 
study to determine whether current OSHA exposure standards used on 
firing ranges are protective. The committee concluded that the current 
OSHA standard of a BLL of under 40 [mu]g/dL is not sufficiently 
protective of personnel who have repeated lead exposures on firing 
ranges (NRC, 2013). DOD subsequently lowered the medical removal 
triggers for BLLs in military and civilian DOD personnel. DOD's medical 
removal is based on BLLs at or greater than 20 [mu]g/dl, and employee 
return to work when BLL is at or below 15 [mu]g/dL (DOD, 2018, p. 55; 
Table C4.T2, pp. 57-61). In 2018, NIOSH published a Request for 
Information (RFI) indicating NIOSH's intent to update its recommended 
exposure limit (REL) for inorganic lead and to develop updated 
recommendations for handling of inorganic lead and medical surveillance 
in the workplace (NIOSH 2018).
    Several states have initiated updates to their occupational lead 
standards. In 2018 Michigan OSHA's State Plan


(MIOSHA) in the Michigan Department of Licensing & Regulatory Affairs 
revised its lead standards for general industry and construction. The 
revisions included changing the BLL at which an employee is required to 
be removed from lead exposure, previously 50 [mu]g/dL, to 30 [mu]g/dL 
for both standards. In addition, the BLL at which an employee may be 
returned to work involving lead exposure was changed from < 40 [mu]g/dL 
to 15 [mu]g/dL in both standards. MIOSHA also removed a previous 
requirement to analyze for the zinc protoporphyrin (ZPP) level. 
MIOSHA's revisions followed recommendations developed by a group of 
stakeholders over the course of meetings held in 2017 and 2018. The 
group's proposed revisions to the occupational standards were the 
subject of public hearings in August 2018 and became effective in 
December 2018 (MOEMA 2019, p. 8). Michigan's revisions did not alter 
the PEL for lead.
    The California Department of Public Health (CDPH) Occupational Lead 
Poisoning Prevention Program made recommendations for revisions to the 
California OSHA (Cal/OSHA) lead standards for general industry in 2010 
and construction in 2011, including recommendations to lower the BLLs 
for medical removal and return to former job status; require more 
frequent BLL testing; broaden the provision and notification processes 
for BLL testing for exposed workers; and lower the 8-hour time-weighted 
average (TWA) PEL (CDPH, 2010; CDPH, 2011). CDPH's recommendation for 
lowering the PEL was based on a report produced by the California 
Environmental Protection Agency (Cal/EPA, Office of Environmental 
Health Hazard Assessment (OEHHA)) that used an updated physiologically-
based pharmacokinetic (PBPK) model to characterize the relationship 
between air lead levels and BLLs (OEHHA, 2014).
    Cal/OSHA has held advisory meetings to discuss potential changes to 
its lead standards and has published a discussion draft of possible 
amendments to the existing regulations in general industry and 
construction operations. California's most recent discussion draft 
includes a medical removal level of 30 [mu]g/dL for a single test 
result; or when the last two monthly blood lead tests are >= 20 [mu]g/
dL; or when the average of the results of all blood lead tests 
conducted in the last 6 months is at or above 20 [mu]g/dL of whole 
blood. The discussion draft includes a return to former job status when 
two consecutive blood lead tests are <= 15 [mu]g/dL. The discussion 
draft also includes a reduction in the PEL from 50 [mu]g/m\3\ to 10 
[mu]g/m\3\ and the AL from 30 [mu]g/m\3\ to 2 [mu]g/m\3\, among other 
changes. The discussion draft and related documents are available at 
https://www.dir.ca.gov/dosh/DoshReg/5198Meetings.htm.
    Washington State Department of Labor & Industries, Division of 
Occupational Safety and Health (Washington DOSH), is also developing a 
variety of updates to Washington State's occupational lead standards. 
In 2012, Public Health--Seattle and King County (PHSKC) petitioned the 
Washington State Department of Labor & Industries to update the 
occupational lead standards, including the BLLs for medical removal and 
return to former job status; the AL and PEL; and provisions for 
protective clothing, hygiene, medical surveillance, training, and 
education. Washington DOSH has proposed lowering its medical removal 
BLL to >= 30 [mu]g/dL for a single test result, >= 20 [mu]g/dL for 
multi-test results, and a return to former work status BLL of < 15 
[mu]g/dL. Washington DOSH has also proposed a reduction in the PEL from 
50 [mu]g/m\3\ to 20 [mu]g/m\3\, among other changes to the lead 
standard. Washington DOSH's stakeholder review draft (2019) and other 
information related to its stakeholder meetings on the lead rule 
revision process are available at https://lni.wa.gov/safety-health/safety-rules/rulemaking-stakeholder-information/sh-rules-stakeholder-lead.
    OSHA is also considering revisions to its lead standards. Through 
this ANPRM, OSHA seeks input on the BLL triggers used for medical 
removal and return to work status. The agency also requests information 
on other potential changes to the current standards to reduce the risk 
of adverse health effects from occupational lead exposure.

B. Industry Profile Information

    In accordance with OSHA's intent to assess the potential impacts of 
revising blood lead triggers for medical removal protection, the agency 
made preliminary estimates of the annual number of firms, by industry, 
expected to have workers with elevated BLLs. For these estimates, OSHA 
used the reporting levels in CDC's Adult Blood Lead Epidemiology and 
Surveillance (ABLES) dataset of 5 [mu]g/dL, 10 [mu]g/dL, and 25 [mu]g/
dL, and OSHA's lead standards' medical removal levels (50 [mu]g/dL for 
construction and 60 [mu]g/dL for general industry).
    OSHA identified the industry sectors associated with lead exposure 
as those found in the ABLES dataset. This dataset shows that the 
national prevalence rate of BLLs >=10 [mu]g/dL for adults declined from 
26.6 adults per 100,000 employed in 2010 (among 37 reporting states) to 
15.8 in 2016 (among 26 reporting states). For context, the geometric 
mean BLL for all adults in the US (including workers) was 0.855 [mu]g/
dL in 2018 (HHS, 2022). Historically, in the U.S., most lead exposures 
among adults have been occupational. Among the 11,695 adults with known 
lead exposures at BLL of >=10 [mu]g/dL in 2016, 90.3% had occupational 
exposures. The majority of these adults were employed in four main 
industry sectors: manufacturing, construction, services, and mining 
(NIOSH, 2016).
    To help inform the rulemaking process, OSHA contracted with Abt 
Associates to generate preliminary estimates of the number of 
establishments and cases across all states at the ABLES reporting 
levels of 5 [mu]g/dL, 10 [mu]g/dL, 25 [mu]g/dL, and the lead standards' 
medical removal levels (50 [mu]g/dL for construction and 60 [mu]g/dL 
for general industry). The first step was to identify industry sectors 
associated with lead exposure by 4-digit NAICS that were identified in 
a 2017 CDPH report (Payne, 2017), industries identified by OSHA in the 
personal sampling data reported by the OSHA Information System (OIS) 
(OSHA, 2020a), and industries with violations of lead exposure medical 
surveillance requirements in the last 10 years of OSHA inspections and 
violations (OSHA, 2020b; OSHA, 2020c). To estimate the number of 
workers with BLLs at or above each ABLES reporting level and the OSHA 
standards' medical removal levels by NAICS, BLL data from the ABLES 
program and the CDPH Occupational Blood Lead Registry for the years 
2012-2014 and 2015-2018 (Payne, 2017; CDPH, 2020a; CDPH, 2020b) were 
pooled. Because ABLES data are limited to those states that report 
testing results to ABLES, the next step was to use U.S. Census data to 
extrapolate a preliminary estimate of the national number of cases from 
the ABLES state data. The method and results are described in full in 
the memorandum entitled Estimated Number of Work-Related BLL Cases and 
Firms (Abt Associates, 2021). This memorandum includes a table that 
provides the number of firms with preliminary BLL estimates at or above 
the relevant levels (the ABLES reporting levels and the OSHA standards' 
medical removal levels) and a table that provides the number of workers 
with preliminary BLL estimates at or above the relevant levels; the 
preliminary BLL estimates are presented by industry. In Appendix A at 
the end of this ANPRM, Table 1 ``Summary of Annual Number of Firms


with BLL Tests and Cases'' presents the estimated number of firms where 
employees received test results that were at or above each ABLES 
reporting level and the OSHA standards' medical removal levels.
    Of 44,144 firms where employee BLLs are tested, 8,611 firms were 
estimated to have recorded BLLs equal to or above 5 [mu]g/dL, while 
2,087, were estimated to have recorded BLLs at or above 25 [mu]g/dL; 
only 137 firms were estimated to have baseline BLL cases annually 
resulting in medical removal protection under OSHA's existing 
requirements (BLLs greater than or equal to 50 and 60 [mu]g/dL for 
construction and general industry, respectively).
    This preliminary analysis shows that, among all affected employers, 
approximately 44 percent of firms where employee BLL is tested are in 
five industry groups: NAICS 7139: Other Amusement and Recreation 
Industries (6,656 firms); NAICS 3272: Glass and Glass Product 
Manufacturing (5,156 firms); NAICS 8111: Automotive Repair and 
Maintenance (3,333 firms); NAICS 2383: Building Finishing Contractors 
(2,746 firms); and NAICS 5629: Remediation and Other Waste Management 
Services (1,663 firms). OSHA requests public input on the agency's 
preliminary profile of affected industries, in particular the list of 
affected NAICS industries and the estimated number of firms that have 
workers with BLLs at or above the selected thresholds.

C. Health Effects of Lead Exposure

    Exposure to lead is associated with adverse health effects, 
including but not limited to effects on the reproductive, 
cardiovascular, neurological, respiratory, and immune systems. As 
highlighted by a National Research Council report (NRC, 2013), lead has 
been shown to have both acute and chronic toxic effects, affecting 
virtually every organ and system in the body (ATSDR, 2020). Since 
OSHA's lead standard for general industry was promulgated, BLLs in the 
general adult population have declined from an overall mean blood-lead 
level of 15.8 [mu]g/dL (1976-1980) to 0.855 [mu]g/dL in 2018, primarily 
reflecting the decrease in lead used in gasoline production, as well as 
the removal of lead from consumer paint (CDC, 1982; HHS, 2022, p. 212; 
ATSDR, 2020, p. 2). However, extensive research has emerged indicating 
that adverse health effects can occur in adults with lower BLLs than 
was previously recognized (ATSDR, 2020; ACGIH, 2013; CDPH, 2009 and 
2013; EPA, 2013; NTP, 2012). For example, BLLs as low as 5 [mu]g/dL 
have been associated with impaired kidney and reproductive function, 
high blood pressure, and cognitive effects attributed to prenatal 
exposure. Poorer performance on neurocognitive and neuropsychologic 
assessments were observed in adults with BLLs as low as 5-19 [mu]g/dL 
compared with adults with BLLs below 5 [mu]g/dL (Kosnett, 2007, pp. 
464, 466; EPA, 2013, pp. 4-311--4-313, 2013; NTP, 2012, pp. 19-42). 
While there is also evidence of adverse health effects in adults with 
BLLs below 5 [mu]g/dL, those are not discussed in OSHA's literature 
review (please see ATSDR, 2020). Table 1 provides an overview of the 
adverse health effects associated with adult lead exposure, including 
the effects of exposure on pregnant workers and their developing 
fetuses, and longer-term effects on children/adolescents exposed in 
utero to lead.

 Table 1--Overview of Adverse Health Effects Associated With Exposure to
                             Lead in Adults
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------------------------------------------------------------------------
          Health Effect             Descriptive Detail of Health Effect
------------------------------------------------------------------------
Reproductive and Developmental    Reduced fertility, low sperm mobility,
 \3\.                              increased risk of miscarriage.
                                  Effects on developing fetus due to
                                   lead exposure in utero--decreased
                                   birth size, adverse effects on
                                   developing brain, kidney, nervous
                                   system, cognitive and learning
                                   disabilities, decreased child growth,
                                   delayed onset puberty.
                                 ---------------------------------------
Vascular/Cardiovascular.........  Hypertension......  Increased systolic
                                                       and/or diastolic
                                                       pressure, stroke,
                                                       heart disease.
                                  Cerebrovascular...  Stroke.
                                  Cardiac/            Heart disease,
                                   cardiovascular.     atherosclerosis,
                                                       altered cardiac
                                                       conduction.
                                 ---------------------------------------
Hematological...................  Heme synthesis (interference with iron
                                   uptake), anemia, altered levels of
                                   plasma erythropoietin.
Neurological....................  Reduced performance on neurocognitive
                                   and neuropsychological tests,
                                   peripheral neuropathy, psychiatric
                                   symptoms (depression, panic
                                   disorders, anxiety, hostility, anger,
                                   schizophrenia) cognitive decrements,
                                   lead intoxication, dementia, hearing
                                   loss.
Renal...........................  Nephrotoxicity (proximal tubular
                                   nephropathy, glomerular sclerosis,
                                   interstitial fibrosis, tubular
                                   necrosis).
Respiratory.....................  Decreased lung function, increased
                                   bronchial hyperreactivity, increased
                                   risk of asthma and obstructive lung
                                   disease.
Endocrine (excluding              Alteration of serum thyroid levels
 reproductive).                    (T3, T4, TSH), decreased levels of
                                   serum vitamin D.
Hepatic.........................  Liver enlargement, increased gall
                                   bladder wall thickness, increased
                                   total cholesterol.
Musculoskeletal.................  Bone loss, increased bone metabolism/
                                   turnover, adverse periodontal and
                                   dental effects.
Gastrointestinal................  Constipation, colic, abdominal cramps.
Body weight.....................  Decreased body mass index (BMI) in
                                   adolescents and adults.
Immunological...................  Decreased complement, changes in
                                   indicators of inflammation
                                   (monocytes, macrophages, neutrophils)
                                   and cell-mediated immunity (T cells,
                                   natural killer cells).
Cancer..........................  Lung, stomach, kidney, and brain
                                   cancer.
------------------------------------------------------------------------
Based on information contained in ATSDR, 2020.



1. Routes and Kinetics of Lead Exposure
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    \3\ For more information on pregnancy and lead exposure please 
see https://www.cdc.gov/nceh/lead/publications/leadandpregnancy2010.pdf.
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    Lead exposures in adults above background or baseline levels are 
typically associated with occupational exposures. Background or 
baseline levels occur from incidental exposures through ambient air, 
foods, drinking water, soil, and dust and result in an average BLL for 
adults of 0.855 [mu]g/dL (geometric average) (ATSDR, 2020; HHS, 2022). 
Occupational exposure to lead can occur through inhalation, oral, and/
or dermal routes (EPA, 2013, pp. 7-18; NAS, 2013, pp. 9, 15-17, 47). 
The Agency for Toxic Substances and Disease Registry (ATSDR) has stated 
that all the health effects discussed here can result from all three of 
these routes of exposure (ATSDR, 2020).
    Lead accumulates in the body with continued or chronic exposure 
(ATSDR, 2020; AOEC, 2007; EPA, 2013; NTP, 2012; Shih, 2007). In adults, 
90 percent of lead is stored in bone, with only 1 percent in blood 
(EPA, 2013, pp. 4-324--4-326). Lead can be released from bone to blood 
and other soft tissues over time. In particular, lead can be mobilized 
from bone even after removal from occupational exposure; after use of 
chelation therapy to reduce BLLs; during age-related bone loss, 
especially menopause and osteoporosis; and during pregnancy and 
lactation (EPA, 2013; NTP, 2012). Because lead is retained in the bones 
and can be released into the bloodstream over time, it is difficult to 
predict individuals' BLLs from their recent external exposures (NAS, 
2013; ATSDR, 2020).
    Multiple factors can influence the toxico- and pharmacokinetics of 
lead in the body, including genetic polymorphisms, nutrition and diet, 
smoking, gender, and age (NAS, 2013). California OEHHA developed a 
pharmacokinetic model which indicated that when BLLs during the working 
lifetime (characterized in the model as 40 hours per week over a 40-
year working life) are maintained below 20 [mu]g/dL, medical removal is 
expected to result in a fairly rapid decline to a BLL of 15 [mu]g/dL, 
which was selected as an acceptable BLL for the purposes of the model 
(OEHHA, 2014, pp. 3-4). For example, the 95th percentile worker \4\ 
removed after forty years of exposure with a BLL of 20 [mu]g/dL would 
be expected to decline to 15 [mu]g/dL within ten weeks. If BLLs are 
allowed to reach the 50 [mu]g/dL currently allowed under OSHA 
standards, the California OEHHA model estimates that medical removal 
periods greater than 18 months would be generally necessary to reduce 
BLLs to 15 [mu]g/dL, even among workers with only one year of 
occupational exposure (OEHHA, 2014, pp. 3-4).
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    \4\ The phrase `95th percentile worker' in this context means 
that ninety five percent of the workers removed from lead exposure 
after a 40-year work life of lead exposure resulting in a BLL of 20 
[mu]g/dL would be expected to take 10 weeks for their BLLs to 
decline 5 [mu]g/dL to 15 [mu]g/dL.
---------------------------------------------------------------------------

    Table 2 highlights some of the adverse health effects associated 
with various BLLs. While these findings are based on clinical 
assessments from comprehensive reviews, they do not necessarily 
represent strict threshold values as certain health endpoints may 
manifest at lower or higher levels in some individuals or groups.

   Table 2--Overview of Health Effects Associated With Elevated BLL in
                                 Adults
------------------------------------------------------------------------
          BLL ([mu]g/dL)                       Health effects
------------------------------------------------------------------------
5-10..............................  Acute decrease in renal function.
                                    Elevated blood pressure.
                                    Altered heme synthesis.
                                    Impaired neurocognitive and
                                     neuropsychological assessment.
                                    Developmental effects (e.g.,
                                     decreased cognitive and reduced
                                     birthweights)--fetuses exposed to
                                     lead in utero through pregnant
                                     worker lead exposure.
10-20.............................  Spontaneous abortion (miscarriage).
                                    Hypertension.
                                    Decreased renal function.
                                    Decreased platelet count.
                                    Decreased blood hemoglobin.
20-40.............................  Headache.
                                    Fatigue.
                                    Anemia.
                                    Sleep disturbance.
                                    Anorexia.
                                    Bowel changes.
                                    Arthralgia.
                                    Myalgia.
                                    Decreased libido.
                                    Personality changes
40-60.............................  Sperm effects (decreased number and
                                     function).
                                    Subclinical peripheral neuropathy.
                                    Altered red blood cell function.
                                    Renal damage.
                                    Cognitive dysfunction.
60-80.............................  Hemolytic anemia.
                                    Renal failure.
                                    Stroke.
Above 80..........................  Central Nervous System (CNS)
                                     effects.
                                    Nephropathy.
                                    Gout.
                                    Hearing loss.
                                    Encephalopathy.
------------------------------------------------------------------------
Adapted from AOEC, 2007. For additional resources please also see: NTP
  Monograph on Health Effects of Low-Level Lead, available at https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf.



2. Medical Surveillance and Management for Elevated Blood Lead
    A comprehensive medical surveillance program can be an invaluable 
tool in assessing the healthfulness of a workplace. Medical 
surveillance incorporates a systematic assessment of employees' health 
through medical monitoring and management practices (NIOSH, 2018). OSHA 
included a medical surveillance provision in the 1978 lead standard in 
part to mitigate some of the most detrimental effects of lead exposure 
to workers. However, since OSHA promulgated the standard, much more has 
become known regarding acute and chronic exposures (especially at low 
levels) and susceptible populations.
Measurement and Management of Blood Lead Levels (BLLs)
    OSHA, as well as a number of agencies and public health groups 
state that the BLL is the best method available to monitor lead 
exposure (1910.1025, Appendix C; ACOEM 2016, p. e372; AOEC 2007, p. 4; 
CDPH 2009, p. 4; CSTE 2015, p. 2). OSHA and others have noted that BLL 
is generally a good indicator of current or recent external lead 
exposure; however, it is not necessarily correlated with total body 
burden of lead or cumulative exposure (29 CFR 1910.1025, Appendix C; 
AOEC 2016, pp. 4-7; CDPH 2009, p. 4; NAS 2013, pp. 48-56). This is 
because, over time, a high percentage of lead is deposited in bone, and 
after exposure ends, mobilization from bone occurs very slowly. As a 
result, a high BLL may represent a high recent exposure without an 
excess of total body burden, and a low BLL does not necessarily mean 
that total body burden is low (29 CFR 1910.1025). For long-term, long-
latency, or cumulative exposures, lead body burden is generally 
considered the most adequate method (NAS 2013, p. 64). Lead body burden 
can be measured using x-ray fluorescence techniques but such methods 
are currently not widely or readily available (ACOEM 2016, p. e372; 
CSTE 2015, p. 2).
    Medical management guidelines for adult lead exposure were 
developed by a national expert panel coordinated by the Association of 
Occupational and Environmental Clinics (AOEC 2007, pp. 5-9, 13), in 
collaboration with the ABLES program. The authors recommend that 
maintaining BLLs below 20 [mu]g/dL over a twenty-year period, or under 
10 [mu]g/dL over a forty-year period, would be sufficient to prevent 
chronic effects associated with adult lead exposure. They further 
recommend maintaining BLLs below 20 [mu]g/dL in order to prevent 
recognized acute health effects (Schwartz and Hu, 2007). ACOEM states 
that the most compelling evidence for adverse health effects occurs at 
moderate levels of blood lead ranging from 10 to 20 [mu]g/dL (ACOEM 
2016, p. 1). In the context of general population screening, the CDC 
recommends adult BLLs (persons >=16 years of age) from a venous blood 
specimen of >=5 [mu]g/dL be considered for case classification for the 
purposes of medical surveillance (CDC 2016, p. 260); ABLES uses 5 
[mu]g/dL to indicate an elevated BLL for surveillance purposes (ABLES, 
2021). NIOSH additionally provides a reference guide to BLL regulations 
and recommendations (ABLES, 2021).
    The following sections outline the current medical management and 
monitoring practices required under OSHA's lead standards, in order to 
contextualize OSHA's later questions regarding possible changes to 
these requirements in Section II, Request for Input.
Methods for Monitoring Blood Lead Levels in OSHA's Standards
    OSHA's lead standards do not specify a particular method for 
analyzing BLL but require that the method of sampling and analysis used 
is accurate to plus or minus 15 percent or 6 [mu]g/100 ml, whichever is 
greater (to a 95 percent confidence level). The general industry 
standard once required the analysis to be conducted by a laboratory 
licensed by the CDC or which has received a satisfactory grade in blood 
lead proficiency testing from the CDC within the previous 12 months 
(per 29 CFR 1910.1025(j)(2)(iii)), but now allows testing to be 
conducted in a CLIA compliant laboratory (OSHA, 2018).\5\ The 
construction standard requires the analysis to be conducted by a 
laboratory approved by OSHA (29 CFR 1926.62(j)(2)(iii)). The medical 
surveillance guidelines in Appendix C of OSHA's lead standards indicate 
that any method that meets the accuracy specified by the standards can 
be used to analyze the blood sample.
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    \5\ In a memorandum to OSHA Regional Administrators, the agency 
specified that in lieu of approval by OSHA or CDC, the agency will 
accept the use of a blood lead analysis laboratory that has been 
approved under the U.S. Department of Health and Human Services 
(HHS), Centers for Medicare and Medicaid Services (CMS), blood lead 
laboratory monitoring system pursuant to the Clinical Laboratory 
Improvement Amendments (CLIA) regulations, 42 CFR part 493 (OSHA 
2018).
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OSHA's Requirements for Blood Lead and Zinc Protoporphyrin Testing, 
Worker Notification of Blood Lead Levels, Medical Removal, and Return 
to Work
    The medical surveillance and medical removal protection provisions 
in OSHA's lead standards contain BLL triggers for medical removal, 
return to work status, and employee notification of blood test results. 
The general industry standard requires employers to institute a medical 
surveillance program for all employees who are or may be exposed at or 
above the action level of 30 [mu]g/m\3\ for more than 30 days per year 
(29 CFR 1910.1025(j)). Employers must make biological monitoring in the 
form of blood lead testing and ZPP levels available to these employees 
in accordance with the following schedule provided in 29 CFR 
1910.1025(j)(2)(i):
     At least every six months to each employee covered under 
paragraph (j)(1)(i) of the standard;
     At least every two months for each employee whose last 
blood lead test indicated a BLL at or above 40 [mu]g/dL. This frequency 
shall continue until two consecutive blood lead tests indicate a BLL 
below 40 [mu]g/dL; and
     At least monthly during the removal period of each 
employee removed from exposure to lead due to an elevated BLL.
    OSHA's lead standard for construction requires the employer to make 
blood sampling and analysis for lead and ZPP levels available to 
employees occupationally exposed on any day to lead at or above the 
action level (29 CFR 1926.62 (j)(1)(i)). It further requires the 
employer to institute a medical surveillance program for all employees 
who are or may be exposed by the employer at or above the action level 
for more than 30 days in any consecutive 12 months (29 CFR 1926.62 
(j)(1)(ii)) and requires employers to provide blood lead testing to 
employees in the medical surveillance program at least every two months 
for the first six months, and every six months thereafter (29 CFR 
(1926.62 (j)(2)(i)(A)). Furthermore, the employer is required to 
provide blood lead testing at least every two months for employees 
covered under (j)(1)(i) or (ii) whose last test indicated a BLL at or 
above 40 [micro]g/dL, until two consecutive tests show the BLL has 
declined below 40 [micro]g/dL. And, the standard requires the employer 
to provide blood lead testing at least monthly during the removal 
period of each employee removed from exposure to lead due to an 
elevated BLL (29 CFR 1926.62(j)(2)(i)(C)).


    OSHA's general industry standard requires the employer to notify 
each employee whose BLL is at or above 40 [micro]g/dL within five 
working days after the receipt of biological monitoring results. OSHA's 
construction standard requires the employer to notify each employee in 
writing of their BLL within five working days after the receipt of 
biological monitoring results, regardless of the BLL detected.
    The general industry standard requires an employer to remove an 
employee from work involving exposure to lead at or above the action 
level when two consecutive blood lead tests are at or above 60 
[micro]g/dL; or when the average of the last three tests (or the 
average of all tests conducted over the previous six months, whichever 
period is longer) is at or above 50 [micro]g/dL, with the exception 
that medical removal is not required if the last test indicates a BLL 
below 40 [micro]g/dL. It also requires medical removal when a final 
medical determination concludes that an employee has a medical 
condition that places the employee at increased risk of material 
impairment to health from exposure to lead (29 CFR 1910.1025(k)). The 
construction standard requires an employer to remove an employee from 
work involving exposure to lead at or above the action level when the 
employee's BLL is at or above 50 [micro]g/dL for two consecutive tests 
or a final medical determination concludes that the employee has a 
medical condition that places the employee at increased risk of 
material impairment to health from exposure to lead (29 CFR 
1926.62(k)). Both standards specify that the employer shall return an 
employee to the employee's former job status when two consecutive blood 
sampling tests indicate that the BLL is below 40 [micro]g/dL (29 CFR 
1910.1025(k)(1)(iii)(A)(1); 29 CFR 1926.62(k)(1)(iii)(A)(1)).
Zinc Protoporphyrin (ZPP) Testing
    Along with BLLs, ZPP testing is required by OSHA's lead standards 
as part of its medical surveillance and management plan (29 CFR 
1910.1025(j)(2); 29 CFR 1926.62(j)(2)). ZPP is a metabolite found in 
erythrocytes during hemoglobin synthesis. The zinc in ZPP replaces iron 
in hemoglobin synthesis during times of iron deficiency. Elevated lead 
levels in the blood interfere with iron ion transfer, creating a 
condition similar to iron deficiency, thus elevating zinc in the 
production of hemoglobin and ZPP.
    The clinical utility of ZPP testing to identify elevated BLL is now 
understood to be limited by several factors:
     Low sensitivity: ZPP is generally not elevated until BLLs 
exceed 25 [micro]g/dL (Kosnett et al 2007, p. 468). Thus, workers may 
reach harmful BLLs well before the ZPP level registers as abnormal.
     Low specificity: ZPP is not specific to lead. In other 
words, elevated levels of ZPP can be caused by conditions other than 
blood lead, such as iron deficiency anemia, jaundice, and sickle cell 
anemia (ATSDR 2020, p. 336). Thus, an elevated ZPP does not always mean 
that a worker has an elevated BLL.
     Lag time: ZPP levels generally lag behind BLLs by two to 
six weeks (CDPH 2009, p. 4). Thus, a worker may have an elevated BLL 
while the ZPP level is still within normal range. The reverse is also 
true; a worker's BLL may begin to decline, while the lagging ZPP level 
remains elevated (Martin 2004, pp. 589-590). This delay limits the 
utility of ZPP as a screening or biomonitoring tool.
     High individual variability: Individuals with the same BLL 
can have widely differing ZPP levels (Martin 2004, pp. 588-590). This 
may be due to differences in individual susceptibility to lead 
(Grandjean 1991, pp. 111-112) or other factors. However, such 
variations can complicate interpretation of test results.
    Both AOEC and CDPH recommend against routine clinical use of ZPP--
unless legally required--for monitoring lead-exposed patients (AOEC, 
2007; CDPH 2009, p. 4). Similarly, ATSDR notes that ``ZPP is not 
sufficiently sensitive at lower BLLs and therefore is not as useful a 
screening test for lead exposure as previously thought'' (ATSDR 2007, 
pp. 232-233). OSHA's enforcement policy currently allows employers to 
use methods other than the ZPP test for determining lead toxicity. See 
www.osha.gov/laws-regs/standardinterpretations/1996-03-04-1. Due to 
these issues, OSHA is requesting input on whether to eliminate the 
requirement for ZPP monitoring (see Section II, Request for Input).

II. Request for Input

    This ANPRM seeks input on the following areas: OSHA's triggers for 
medical removal of workers with elevated BLLs and their return to lead-
exposed work; OSHA's requirements for medical surveillance and 
management of lead-exposed employees; several additional provisions and 
compliance protocols that are undergoing public review in State Plans' 
ongoing work to update their occupational lead standards; and the costs 
and effectiveness of lead exposure identification and control 
strategies. This Request for Input section includes a series of 
questions on the OSHA standards' requirements and possible revisions to 
them, followed by a series of questions on employers' requirements, 
which may in some cases be more protective than OSHA standards. While 
the questions pertaining to current requirements are primarily 
addressed to employers, OSHA will review and consider all information 
submitted in response to these questions.
    This section includes questions about several provisions of OSHA's 
lead standards that are addressed in recent or proposed changes to 
State Plan lead standards in Michigan, Washington State, and 
California. As previously discussed, in January 2019 MIOSHA revised its 
lead standards for general industry and construction, changing the BLL 
at which an employee is required to be removed from lead exposure and 
the BLL at which an employee may be returned to lead exposure. Cal/OSHA 
has held advisory meetings to discuss a variety of potential changes to 
its lead standards and has published a draft of possible amendments to 
the existing regulations in general industry and construction 
operations. 6 7 Washington DOSH is also developing a variety 
of updates to DOSH's occupational lead standards.\8\ For several lead 
standard provisions that State Plans have made or proposed changes to, 
this section describes the changes in the relevant State Plan(s) and 
requests input on whether similar revisions to federal lead standards 
should be considered. The State Plan changes and proposals include 
revisions to state blood lead triggers for medical removal protection 
and return to work; permissible exposure limits; and several ``safe 
harbor'' protocols that employers in certain industries, or who meet 
specified requirements, may opt to use as alternatives to complying 
with the main rule.
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    \6\ California's most recent discussion draft and other 
materials related to the advisory meetings are available at https://www.dir.ca.gov/dosh/DoshReg/5198Meetings.htm.
    \7\ The California Department of Public Health (CDPH) 
Occupational Lead Poisoning Prevention Program (OLPPP) made 
recommendations to Cal/OSHA for revising its General Industry Lead 
Standard and Construction Industry lead standards for the protection 
of workers who are exposed to lead on the job, available at https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/OLPPP/Pages/LeadStdRecs.aspx.
    \8\ Washington DOSH's stakeholder review draft (2019) and other 
information related to its stakeholder meetings on the lead rule 
revision process are available at https://lni.wa.gov/safety-health/safety-rules/rulemaking-stakeholder-information/sh-rules-stakeholder-lead.
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    Several questions in this section also relate to recommendations 
made by the



Association of Occupational and Environmental Clinics (AOEC, 2007) and 
ACOEM (2016, pp. e371-e372) for updates to OSHA's Lead standards. 
ACOEM's recommendations refer to ``significant lead exposure'', defined 
as an airborne or surface lead content known or reasonably anticipated 
to cause elevated BLL (ACOEM 2016, p. e372, Table 1); and refer to a 
``lead-exposed worker'', defined as ``any worker who is handling or 
disturbing materials with a significant lead content in a manner that 
could reasonably be expected to cause potentially harmful exposure 
through lead dust inhalation or ingestion, regardless of airborne lead 
concentrations or surface contamination levels'' (ACOEM 2016, p. e372).
    OSHA notes that this ANPRM focuses primarily on medical 
surveillance/medical removal protection and on state-based innovations. 
Therefore, it does not request input on every provision OSHA might seek 
to modernize or otherwise revise in its lead standards through a Notice 
of Proposed Rulemaking (NPRM) in the future.
    When answering the numbered questions below, please label your 
responses with the number of the question, explain the reasons 
supporting your views, and identify and provide relevant information on 
which you rely, including, but not limited to, data, studies, and 
articles.

A. Blood Lead Triggers for Medical Removal Protection

1. Requirements for Medical Removal
    OSHA's general industry standard for lead requires an employer to 
remove an employee from work involving exposure to lead at or above the 
action level (30 [micro]g/m\3\) when two consecutive blood lead tests 
are at or above 60 [micro]g/dL or when the average of the last three 
tests is at or above 50 [micro]g/dL. OSHA's construction standard 
requires an employer to remove an employee from work involving exposure 
to lead at or above the AL when the employee's BLL is at or above 50 
[micro]g/dL for two consecutive tests. (See Section I.C, Health Effects 
of Lead Exposure, for a full description of OSHA's blood lead 
requirements for Medical Removal Protection (MRP)).
    ACOEM has recommended medical removal of workers who have repeat 
BLLs over 20 [micro]g/dL (measured in four weeks), or if any single BLL 
exceeds 30 [micro]g/dL (ACOEM 2016, p. e372, Table 1). MIOSHA's 2019 
update to Michigan's occupational lead standard changed the BLL at 
which an employee in general industry or construction is to be removed 
from lead exposure, previously 50 [micro]g/dL, to 30 [micro]g/dL for 
both standards. Cal/OSHA's discussion draft includes a medical removal 
BLL of >= 30 [micro]g/dL; when the last two monthly blood lead tests 
are >= 20 [micro]g/dL; or when the average of the results of all blood 
lead tests conducted in the last six months is at or above 20 [micro]g/
dL of whole blood. Washington DOSH's stakeholder review draft would 
lower its medical removal BLL to >= 30 [micro]g/dL for a single test 
result and >= 20 [micro]g/dL for multi-test results for both general 
industry and construction lead standards. After commissioning the 
National Research Council (NRC) to conduct a study to determine whether 
current OSHA exposure standards used on firing ranges are protective 
(NRC, 2013), DOD lowered the medical removal triggers for BLLs in 
military and civilian DOD personnel, which previously were aligned with 
OSHA's standards. DOD's medical removal is now based on BLLs at or 
greater than 20 [micro]g/dL (DOD, 2018, p. 55; Table C4.T2, pp. 57-
61)).
    (1) Should OSHA consider changing the BLL at which an employee in 
general industry or construction is to be removed from lead exposure to 
match any of the approaches described above? Is there a different BLL 
trigger for removing a worker from lead-exposed work that you would 
suggest? Please explain your answer and provide supporting information 
or data, if available.
2. Requirements for Return to Lead-Exposed Work
    OSHA's lead standards for general industry and construction both 
specify that the employer shall return an employee to their former job 
when two consecutive blood-sampling tests indicate that the BLL is 
below 40 [micro]g/dL.
    ACOEM has recommended that return to lead-exposed work should be 
considered after two BLLs are below 15 [micro]g/dL (ACOEM 2016, p. 
e372, Table 1). MIOSHA changed the BLL at which an employee may return 
to lead exposure from below 40 [micro]g/dL to below 15 [micro]g/dL in 
both general industry and construction. Cal/OSHA's discussion draft 
would provide that a removed worker may return to former job status 
when two consecutive blood lead tests are below 15 [micro]g/dL. 
Washington DOSH's stakeholder review draft similarly includes a return-
to-work BLL of below 15 [micro]g/dL for both general industry and 
construction lead standards. DOD's updated policy provides for employee 
return to work when BLL is at or below 15 [micro]g/dL (DOD, 2018, p. 
55; Table C4.T2, pp. 57-61)).
    (2) Should OSHA consider changing the BLL below which an employee 
shall be returned to lead exposure to 15 [micro]g/dL? Is there a 
different BLL trigger for returning a worker to lead-exposed work 
following medical removal that you would suggest? Please explain your 
answer and provide supporting information or data, if available.

B. Medical Surveillance Provisions

1. Medical Examination and Consultation Requirements
    OSHA's lead standards require employers to make a full medical 
examination and consultation available to an employee: (1) before the 
first assignment to an area that has lead at or above the action level; 
(2) at least once a year for an employee who had a BLL of 40 [micro]g/
dL or over at any time during the preceding 12 months; and (3) as soon 
as possible on notification by an employee that they have developed 
signs or symptoms of lead intoxication, desire medical advice 
concerning the effects of lead (past or current) and the ability to 
procreate a healthy child, or who has difficulty in breathing during 
respirator fit test or use. In addition, an examination must be made 
available as medically appropriate for each employee either removed 
from exposure to lead due to a risk of sustaining material impairment 
to health, or whose lead exposure is otherwise limited based on a final 
medical determination.
    For the purposes of the lead standard, a full medical examination 
includes: (1) a detailed work and medical history; (2) a thorough 
physical examination; (3) measurement of blood pressure; (4) analysis 
of BLL, hemoglobin and hematocrit, erythrocyte indexes, peripheral 
smear morphology, zinc protoporphyrin (ZPP), blood urea nitrogen and 
creatinine, and urinalysis with microscopic examination; and (5) any 
other tests that a physician thinks are appropriate, including a 
pregnancy test or laboratory evaluation of male fertility if requested 
by the employee.
    (3) Are these still appropriate tests or should a full medical 
examination include any other tests? OSHA is also requesting comment on 
the appropriateness of including the ZPP given its limitations (see 
also Section #6, ``ZPP'', below).
2. Triggers for Routine Blood Lead Monitoring
    OSHA's lead standards require the employer to institute a medical 
surveillance program, including blood lead testing prior to lead 
exposure and at regular intervals thereafter, for employees who are or 
may be exposed


to airborne lead at or above 30 [micro]g/m\3\ for more than 30 days per 
year.
Airborne Lead Exposure Trigger for Blood Lead Monitoring
    The Washington DOSH stakeholder review draft would require 
employers to provide ongoing blood lead monitoring for employees 
exposed to lead for more than 10 days per year, including any day with 
airborne exposure totaling 10 [micro]g/m\3\ as an 8-hour TWA or greater 
or any day with a task lasting 30 minutes or more that involves 
exposure above 20 [micro]g/m\3\. Cal/OSHA's discussion draft would 
require employers to institute a medical surveillance program, 
including blood lead testing, for employees who are or may be exposed 
at or above a revised action level of 2 [micro]g/m\3\ for 10 or more 
days per year.
    (4) Should OSHA consider expanding its criteria for blood lead 
monitoring to resemble the ongoing blood lead monitoring criteria that 
Washington DOSH and/or Cal/OSHA is considering? Are there different 
criteria you would suggest? Please explain your answers.
Additional Triggers
    In OSHA's lead standards, worker eligibility for blood lead 
monitoring is based solely on airborne lead exposure criteria. In 
contrast, the Washington DOSH stakeholder review draft would require 
employers to provide ongoing blood lead monitoring for employees 
exposed at or above any action level for more than 10 days per year, 
including any day involving a combined total of at least one hour of: 
(1) activity disturbing or touching metals containing 20 percent or 
more lead (by weight); (2) activity disturbing non-metals containing 
0.5 percent or more lead by weight; (3) creating aerosols or fumes from 
materials containing 0.1 percent or more lead by weight; or (4) work in 
areas with surfaces at a ``Surface Action Level'' of 1000 [micro]g/
dm\2\ (equivalent to 9290 [micro]g/ft\2\).\9\
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    \9\ See Surface Sampling and Material Content Requirements below 
for percentage and contamination specifications. The Washington DOSH 
Stakeholder Review Draft states that ``work is timed from beginning 
the contact or disturbance activity to the time when the worker 
accesses washing facilities where personal protective equipment can 
be doffed properly and the worker can thoroughly wash off lead 
contamination.''
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    Cal/OSHA's discussion draft includes a requirement that employers 
must institute a medical surveillance program, including blood lead 
testing, for employees who perform a ``trigger amount of lead work'', 
defined as altering or disturbing material that is known or reasonably 
anticipated to contain at least 0.5 percent lead by weight, or torch 
cutting any scrap metal, for a combined total of at least 8 hours 
during any 30-day period.
    In addition, ACOEM has recommended that BLL be measured routinely 
for all lead workers, where a ``lead-exposed worker'' is defined as 
``any worker who is handling or disturbing materials with a significant 
lead content in a manner that could reasonably be expected to cause 
potentially harmful exposure through lead dust inhalation or ingestion, 
regardless of airborne lead concentrations or surface contamination 
levels'' (ACOEM 2016, p. e372).
    (5) Should OSHA consider adding criteria other than airborne lead 
exposure to its requirements for blood lead testing, such as contact 
with lead-contaminated surfaces, disturbance of lead-containing 
materials or direct contact with high-percentage lead materials? In 
particular, should OSHA consider adopting criteria based on contact 
with lead-contaminated surfaces, disturbance of lead-containing 
materials, or contact high lead-content metals, as Washington DOSH's 
stakeholder review draft and Cal/OSHA's discussion draft contemplate? 
Please explain your answer.
3. Frequency of Blood Lead Monitoring
    OSHA's lead standard for general industry requires employers to 
provide blood lead testing to employees in the medical surveillance 
program at least every six months, with the following exceptions: (1) 
every two months if a previous BLL was at or above 40 [micro]g/dL of 
whole blood, until two consecutive results are below 40 [micro]g/dL and 
(2) at least monthly during the removal period of each employee removed 
from exposure to lead due to an elevated BLL.
    For those employees who are in the medical surveillance program 
because they are or may be exposed to airborne lead at or above the 
action level (30 [micro]g/m\3\) for more than 30 days in any 
consecutive 12 months, OSHA's lead standard for construction requires 
the employer to provide blood lead testing at least every two months 
for the first six months, and every six months thereafter. In addition, 
for employees who were exposed on any day to lead at or above the 
action level, and for employees who have been exposed to lead at or 
above the action level for more than 30 days in a 12 month period and 
whose last blood sample indicated a BLL at or above 40 ug/dL, the 
standard requires blood testing at least every two months until two 
consecutive results indicate a BLL below 40 [micro]g/dL. The standard 
also requires the employer to provide blood lead testing at least 
monthly during the removal period of each employee removed from 
exposure to lead due to an elevated BLL. (See Section I.C, Health 
Effects of Lead Exposure, for a full description of OSHA's blood lead 
requirements for MRP).
    ACOEM has recommended that lead workers' BLLs be measured every two 
months for the first six months of placement, or upon change to tasks 
resulting in higher exposure, and that BLLs should be measured every 
six months thereafter (ACOEM 2016, p. e372, Table 1). In addition, 
ACOEM has recommended BLL measurement every two months for workers with 
results between 10 and 19 [micro]g/dL and monthly measurement for 
workers with results of at least 20 [micro]g/dL.\10\
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    \10\ ACOEM's recommendations refer to ``significant lead 
exposure'', defined as an airborne or surface lead content known or 
reasonably anticipated to cause elevated BLL (ACOEM 2016, p. e372, 
Table 1); and refer to a ``lead-exposed worker'', defined as ``any 
worker who is handling or disturbing materials with a significant 
lead content in a manner that could reasonably be expected to cause 
potentially harmful exposure through lead dust inhalation or 
ingestion, regardless of airborne lead concentrations or surface 
contamination levels'' (ACOEM 2016, p. e372).
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    The Washington DOSH stakeholder review draft and Cal/OSHA's 
discussion draft would require that blood lead testing be made 
available every two months for a worker's first six months of testing, 
and every six months after that. In addition, testing would be made 
available at least every two months if a worker's BLL is greater than 
10 [micro]g/dL.
    The Washington DOSH stakeholder review draft would require testing 
to be offered monthly if an employee has been medically removed, until 
two consecutive tests show the worker's BLL has decreased to below the 
proposed return-to-work level.\11\ Cal/OSHA's discussion draft 
stipulates testing at least monthly for each employee whose last BLL 
was at or above 20 [micro]g/dL of whole blood, and during the removal 
period of each employee removed from exposure to lead due to an 
elevated BLL.
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    \11\ The proposed return-to-work level is 15 [micro]g/dL in 
Washington and 10 [micro]g/dL in California.
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    (6) Should OSHA consider revising the required frequency and the 
BLLs related to the schedule of blood lead testing? Would requirements 
similar to those included in Washington DOSH and Cal/OSHA's drafts be 
appropriate? If not, what would be an appropriate frequency for blood 
lead testing? Please explain your answer.
4. Analytical Methods for BLL Testing
    As discussed previously in Section I.C.2, Medical Surveillance and 
Management for Elevated Blood Lead, OSHA standards do not specify a


particular method for analyzing BLL but require that the method of 
sampling and analysis used is accurate to plus or minus 15 percent or 6 
[micro]g/100 ml, whichever is greater (to a 95 percent confidence 
level). In a memorandum to OSHA Regional Administrators, the agency 
specified that in lieu of approval by OSHA or CDC, the agency will 
accept the use of a blood lead analysis laboratory that has been 
approved under the U.S. Department of Health and Human Services (HHS), 
Centers for Medicare and Medicaid Services (CMS), blood lead laboratory 
monitoring system pursuant to the Clinical Laboratory Improvement 
Amendments (CLIA) regulations, 42 CFR part 493 (OSHA 2018). All blood 
lead analysis performed in a CLIA-compliant lab must meet the 
Proficiency Testing requirement of 4 [micro]g/dL or 10%, 
whichever is greater.
    (7) Should OSHA consider revising its standard to require the use 
of a blood lead analysis laboratory that has been approved under the 
CMS blood lead laboratory monitoring system pursuant to the CLIA 
regulations, consistent with OSHA's 2018 memorandum? Please explain 
your answer.
    (8) Are there methods other than collecting a venous sample that 
would meet the accuracy requirements of the lead standard? Please 
describe the advantages and limitations of such methods.
    (9) Are portable direct reading instruments for measuring BLL 
available that meet the accuracy requirements of the OSHA lead 
standards and would be considered equivalent to an analysis conducted 
by a laboratory approved by OSHA or CDC?
    (10) Do you use or have knowledge of other measures of lead in the 
body? Please describe and explain whether and how they could be used 
effectively for medical monitoring of workers exposed to lead and the 
relative costs of those measures (i.e., cost-effectiveness).
5. Employee Notification of BLL Results
    OSHA's general industry standard requires the employer to notify 
each employee whose BLL is at or above 40 [micro]g/dL within five 
working days after the receipt of biological monitoring results. OSHA's 
construction standard requires the employer to notify each employee in 
writing of their BLL within five working days after the receipt of 
biological monitoring results, regardless of the BLL detected.
    The Washington DOSH stakeholder review draft and Cal/OSHA's 
discussion draft include a requirement that employers must make sure 
workers receive all blood testing results, regardless of level, within 
five days of receiving them from the medical providers.
    (11) Should OSHA revise its general industry standard to require 
employers to notify all employees who receive blood lead testing of 
their results, similar to the requirements of its construction standard 
and requirements under consideration by Washington DOSH and Cal/OSHA? 
If not, what criteria should be used to determine which employees 
should be notified of their results? Please explain your answer.
6. ZPP
    ACOEM's Position Statement (2016) advised OSHA that ZPP testing is 
insufficiently sensitive as a measure of lead exposure when BLLs are 
below 25 mg/dL and is no longer needed since BLL testing is superior 
and readily available (ACOEM 2016, p. e372). In January 2019, MIOSHA 
removed a previous requirement to analyze for the zinc protoporphyrin 
level. Washington DOSH's stakeholder review draft and Cal/OSHA's 
discussion draft also would eliminate ZPP testing requirements.
    (12) Should OSHA remove the requirement for ZPP testing currently 
included in its lead standards? Please explain your recommendation to 
continue or discontinue ZPP testing as part of medical surveillance for 
lead-exposed workers.
7. Provisions for Worker Privacy
    Under the medical surveillance provisions of OSHA's lead standards, 
employers are provided with the results of an individual employee's BLL 
measurements, in addition to the physician's opinion as to whether the 
employee has any detected medical condition that would place the 
employee at increased risk from lead exposure; recommended special 
protective measures or lead exposure limitations; and any recommended 
limitation upon the employee's use of respirators. Physicians are 
prohibited from revealing to the employer any findings, including 
laboratory results, or diagnoses unrelated to an employee's 
occupational exposure to lead.
    More recent OSHA standards include measures to enhance employee 
privacy and encourage employees to participate in medical surveillance 
by minimizing fears about retaliation or discrimination based on 
medical findings. In OSHA's beryllium standard, for example, the 
information provided to the employer may not contain the results of 
medical exams performed. The physician may, if authorized by the 
employee in writing, inform the employer of any recommendations for 
limitations on exposure to beryllium and for further testing at another 
facility and/or continued medical surveillance.
    (13) Should OSHA update the lead standards' employee privacy 
protections, including restriction of employer access to an individual 
employee's BLL measurements? Please explain your recommendation.

C. Permissible Exposure Limit (PEL)

    For workers exposed to lead above the PEL of 50 [micro]g/m\3\ for 
more than 30 days per year, OSHA's general industry lead standard 
requires employers to implement engineering and work practice controls 
(including administrative controls) to maintain exposures at or below 
the PEL. For workers exposed to lead above the PEL for 30 days or less 
per year, the standard requires employers to implement engineering 
controls to reduce exposures to lead to 200 [micro]g/m\3\ and then 
allows the use of any combination of controls (engineering, work 
practice, respiratory controls) to maintain exposures at or below 50 
[micro]g/m\3\.
    California and Washington State's drafts include revisions to their 
permissible exposure limits. Cal/OSHA's discussion draft includes a 
reduction in the PEL from 50 [micro]g/m\3\ to 10 [micro]g/m\3\ and the 
action level from 30 [micro]g/m\3\ to 2 [micro]g/m\3\.\12\ The 
Washington DOSH stakeholder review draft includes a reduction in the 
PEL from 50 [micro]g/m\3\ to 20 [micro]g/m\3\.
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    \12\ CDPH contracted with Cal/EPA to evaluate the relationship 
between occupational airborne lead exposure and BLLs. Using health-
based biokinetic modeling, Cal/EPA found that workplace air lead 
levels should be limited to an 8-hour time-weighted average (TWA) of 
2.1 [micro]g/m\3\ in order to prevent BLLs exceeding 10 [micro]g/dL 
in at least 95% of workers with regular and long-term exposure. See 
CDPH 2013 for further details. CDPH's PEL recommendation can be 
viewed at: https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/OLPPP/CDPH%20Document%20Library/LeadStdPELRec.pdf.
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    (14) Should OSHA consider reducing its PEL of 50 [micro]g/m\3\ for 
occupational lead exposure or its action level of 30 [micro]g/m\3\? At 
what level do you believe the PEL should be set to reduce the harmful 
effects of lead exposure in exposed workers? Do you think this level 
would be technologically and economically feasible for affected 
industries (see OSH Act Sec. 6(b)(5), 29 U.S.C. 655(b)(5))? Please 
explain your answer and, if available, provide data pertinent to the 
benefits, feasibility, and expected increase in costs of revising the 
federal PEL or action level for airborne lead. (Please note that OSHA 
requests detailed information on costs of already-existing requirements 
and voluntary


practices in a series of provision-specific questions in Section H, 
Questions for Employers on Current Practices).
    (15) Cal/OSHA's discussion draft includes a Separate Engineering 
Control Airborne Limit (SECAL) for selected processes in lead acid 
battery manufacturing.\13\ Should OSHA consider implementing a SECAL 
for occupational lead exposure for specific processes if industry-wide 
compliance with a proposed revision to the PEL is demonstrably 
infeasible for specific processes?
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    \13\ Specifically, the Cal/OSHA Discussion Draft's SECAL for 
oxide production, paste mixing, grid pasting and parting, and 
battery assembly would require employers to comply with a 50 
[micro]g/m\3\ exposure limit at the effective date, then with a 
limit of 40 [micro]g/m\3\ at five years from the effective date. The 
Cal/OSHA Discussion Draft SECAL for grid production and small parts 
casting, and plate formation would require employers to comply with 
an exposure limit of 50 [micro]g/m\3\ at the effective date, then 
with a limit of 30 [micro]g/m\3\ at five years from the effective 
date.
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    (16) Should OSHA consider removing the provision of OSHA's general 
industry lead standard that allows employers to use respiratory 
protection to comply with the PEL for workers exposed to lead above the 
PEL for 30 days or less per year? Please explain your answer and, if 
applicable, your recommendation on how employers should be required to 
limit exposures of workers exposed above the PEL for 30 days or less 
per year.

D. Personal Protective Equipment (PPE), Hygiene, and Training

    (17) The Washington DOSH stakeholder review draft would require 
employers to provide and ensure the use of impermeable PPE when 
employees are working with lead compounds that may be absorbed through 
the skin for any work covered by the scope of the rule. Should OSHA 
consider a similar requirement for its lead standards? Please explain 
your answer and any evidence available on the feasibility and cost of 
this requirement if adopted by OSHA.
    (18) The Washington DOSH stakeholder review draft would require 
employers to prohibit workers covered by the scope of the rule from 
cleaning or laundering protective clothing or equipment at home. Should 
OSHA consider a similar requirement for its lead standards? Please 
explain your answer and any evidence available on the feasibility and 
cost of this requirement if adopted by OSHA.
    (19) The Washington DOSH stakeholder review draft includes 
requirements that employees be provided with hygiene facilities and PPE 
when any of the following criteria are met:
    1. Employees work in areas with surfaces at a ``Surface Action 
Level'' of 1000 [micro]g/dm\2\ (equivalent to 9290 [micro]g/ft\2\); 
\14\
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    \14\ The Washington DOSH stakeholder review draft defines 
surface contamination as ``free lead in dust or residues on a 
surface that can be transferred to other surfaces on contact'' and 
specifies that single sample testing is sufficient for determining 
whether surfaces are contaminated.
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    2. Employees disturb or touch metals with a ``Metals Action Level'' 
of 20 percent or more lead content by weight;
    3. Employees disturb any materials with a ``Non-metal Action 
Level'' of 0.5 percent or more lead content by weight (5000 ppm); or
    4. Employees welding, burning, or grinding, or otherwise creating 
aerosols or fumes from materials with a ``Burning/Grinding/Blasting 
Action Level'' of 0.1 percent or more lead content by weight (1000 
ppm).
    Material content criteria (items #2 through 4) are applied during 
any activity that could release lead or lead compounds from the 
material in a form that could be inhaled, ingested, or absorbed through 
the skin. The metals action level (item #2) also applies when workers 
directly contact the metal with skin, personal protective equipment, or 
clothing.
    Should OSHA add hygiene and PPE provisions similar to any or all of 
those described above, which are being considered for adoption by 
Washington DOSH? Please explain your answer and, if available, provide 
information on the feasibility and cost of these requirements if 
adopted by OSHA.
    (20) Are there issues or concerns related to surface contamination 
or material content criteria for hygiene and PPE requirements that OSHA 
should consider?
    OSHA's lead standards require employers to provide PPE in a clean 
and dry condition daily to employees whose exposure levels (without 
regard to respirator use) are over 200 [micro]g/m\3\ of lead as an 8-
hour TWA, and weekly for other lead-exposed employees. Cal/OSHA's 
discussion draft would require the employer to provide PPE in a clean 
and dry condition daily to employees whose exposure levels (without 
regard to respirator use) exceed 30 [micro]g/m\3\ of lead as an 8-hour 
TWA. It would maintain the requirement to provide required PPE at least 
weekly for all other lead workers exposed above the proposed PEL (10 
[micro]g/m\3\). Washington DOSH's stakeholder review draft would 
require the employer to replace or launder PPE at least daily for 
employees whose exposure levels exceed 50 [micro]g/m\3\ of lead as an 
8-hour TWA. In addition, it would require the employer to repair, 
replace, or launder protective clothing at least weekly, and when 
visibly contaminated or damaged, for employees whose exposure levels 
exceed 20 [micro]g/m\3\ of lead as an 8-hour TWA.
    (21) Should OSHA consider revising the requirements for employers 
to provide clean or new PPE to workers? Please provide specific 
recommendations for frequency and exposure triggers, and please explain 
your answers.
    (22) Washington DOSH's stakeholder review draft would require that 
the training provided to all lead-exposed workers include information 
on special precautions for pregnant workers. Should OSHA consider 
including a similar requirement to include material on precautions for 
pregnant workers in the training provisions of its lead standards?

E. Safe Harbor Compliance Protocols

    The Washington DOSH stakeholder review draft includes several safe 
harbor protocols which provide employers alternative methods of 
compliance, including some provisions that would relax requirements for 
exposure monitoring and for use of engineering and work practice 
controls to meet the proposed PEL. Employers following a safe harbor 
compliance protocol completely would be considered in compliance with 
the lead rule for tasks covered and would not be cited for departing 
from the main body of requirements of the lead rule for those tasks. 
However, if an employer does not follow the provided safe harbor 
protocol properly, the criteria and requirements of the main body of 
the Washington DOSH rule would be used to assess compliance. The 
Washington DOSH stakeholder review draft includes protocols that could 
potentially be used by an employer in any industry, including the Well 
Managed Blood Lead Levels Safe Harbor Protocol and the Clean Areas Safe 
Harbor Protocol described below, as well as industry- or task-specific 
protocols, including the Safe Harbor Protocol for Handling Lead-
Containing Articles in Retail Settings, the Safe Harbor Protocol for 
Office and Residential Settings, and the Safe Harbor Protocol for 
Incidental Lead Paint in Construction/Renovation, Repair, and Painting 
(RRP) Work described below.
1. Well Managed Blood Lead Levels Safe Harbor Protocol
    The Washington DOSH stakeholder review draft describes a protocol 
that


provides an employer greater flexibility than would otherwise be 
required for implementing PPE, work practices, and other lead exposure 
controls, where the employer demonstrates that their program 
effectively controls employee BLLs. The compliance protocol would 
provide a safe harbor for employers who voluntarily submit worksite 
blood lead records demonstrating that employee BLLs are effectively 
managed. To demonstrate effective control of employee BLLs, the 
employer would be required to conduct blood lead testing for all 
workers at the facility with known or potential exposure to lead; 
provide ongoing documentation of effective blood level management to 
Washington DOSH; and, upon request, communicate with Washington DOSH if 
questions or concerns arise from review of the documentation provided. 
Employers following this protocol would not be subject to scheduled 
inspections for lead related issues, and the requirements associated 
with a new PEL of 20 [micro]g/m\3\ (8-hour TWA) would not be enforced 
where airborne exposures are below the proposed Secondary Permissible 
Exposure Limit (SPEL) of 50 [micro]g/m\3\ (8-hour TWA).\15\
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    \15\ Under this protocol, the following medical surveillance 
provisions would apply: workers with BLLs found above 20 [micro]g/dL 
would be tested monthly until their BLL is below 15 [micro]g/dL for 
two monthly tests; workers would be eligible for the medical removal 
requirements included in the rule; and workers with a BLL greater 
than 10 [micro]g/dL for more than 4 months must have their case 
reviewed by a physician.
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    In the Washington DOSH stakeholder review draft, effective 
management of BLLs is indicated by: blood lead testing for all workers 
at the facility with exposure to lead covered by the rule, including 
baseline tests for all exposed workers, annual tests for all exposed or 
potentially exposed workers, and more frequent tests for all workers 
meeting the requirements for periodic testing in the Washington DOSH 
lead rule; and a record of well managed BLLs, meaning that: (1) the 
average BLLs for workers exposed above 20 [micro]g/m\3\ is below 10 
[micro]g/dL and the BLLs for each worker in the group is kept below 20 
[micro]g/dL; and (2) BLLs for the group of all other workers (those 
exposed below 20 [micro]g/m\3\) are kept below 10 [micro]g/dL.\16\
---------------------------------------------------------------------------

    \16\ Under the Washington DOSH stakeholder review draft, 
infrequent elevated BLLs above 20 [micro]g/dL would not disqualify 
an employer when: (1) the elevated BLL is documented as a baseline 
level prior to work with the company at this facility or any other 
facility operated by the employer, or (2) the employer documents the 
exposure incident responsible for the elevated BLL and takes 
corrective action to effectively prevent further exposures.
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    To qualify for this safe harbor, the employer would be required to 
submit documentation annually for each establishment for which the safe 
harbor will be claimed.\17\ The required documentation includes the 
employer's lead control programs for the establishment; the employer's 
assessments of lead exposures for the establishment; names of all 
workers onsite during the previous two years (including workers of 
other employers); for each worker, whether they are known to have had 
exposures at any action level, at the PEL or at the SPEL; the record of 
all blood lead testing for the establishment for the past two years (or 
new testing only when resubmitting annually); and a report detailing 
actions taken in response to increased lead exposure or elevated blood 
BLLs found during the previous year.
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    \17\ Under the Washington DOSH stakeholder review draft, 
documentation would be submitted annually to maintain coverage by 
the safe harbor, using forms and formats supplied by the DOSH. The 
employer would need to be responsive to questions from the 
department regarding the submitted documentation and must allow for 
onsite auditing of the submission by DOSH. If DOSH reviews the 
documentation and does not agree that it shows that the 
establishment qualifies for this safe harbor, the department would 
notify the employer in writing, including a description of how the 
documentation fails to qualify. If information in the submission 
appears to constitute a violation of a Washington Industrial Safety 
and Health Act (WISHA) rule, the employer would be informed and 
asked to provide proof of abatement for serious violations.
---------------------------------------------------------------------------

    (23) Should OSHA consider a safe harbor protocol approach similar 
to the Well Managed Blood Lead Levels protocol described above, which 
is being considered for adoption in Washington State? What aspects of 
the protocol would be beneficial? Are there issues, concerns, or 
different approaches to a ``safe harbor'' based on well-managed BLLs 
that OSHA should consider?
2. Clean Areas Safe Harbor Protocol
    The Washington DOSH stakeholder review draft describes a protocol 
that would relieve employers from implementing the requirements of the 
lead rule for workers in clean areas who do not have lead-related 
tasks. The clean areas protocol described by Washington DOSH could be 
used to designate parts of a facility, such as offices or work areas 
where lead-containing materials are not present, as clean so that 
workers in those areas are not covered by the lead rule. The protocol 
could also be used for facilities where lead is present in building 
materials, such as lead based paint, but is normally undisturbed by 
activities of the employer. Where a clean area is designated within a 
work establishment, workers and other individuals are not required to 
use protective equipment, work practices, or controls to prevent lead 
exposure and will not necessarily be trained about lead hazards.
    The Washington DOSH stakeholder review draft sets out criteria for 
establishing clean areas, wherein all worker-accessible surfaces must 
be shown using ongoing surface sampling for free lead. Lead coatings 
and lead-containing materials may be present where lead is well 
contained and not released to surface sampling. When sampling indicates 
that lead is being brought into the clean area or released from damaged 
materials in the area, non-lead workers must be kept from the vicinity 
until the hazard is abated and sampling in the area of the release 
indicates the area is clean.
    The following criteria would be used to determine if routine 
cleaning is sufficient to maintain surface lead on all worker 
accessible surfaces below 4.3 [mu]g/dm\2\ (equivalent to 40 [mu]g/
ft\2\). Single sample testing, conducted as specified in Washington 
DOSH's stakeholder review draft, may be used to identify clean areas. 
If initial sampling indicates that lead on worker accessible surfaces 
is below 4.3 [mu]g/dm\2\, the area represented by such sampling is 
considered ``clean'' and the employer would not be required to 
implement requirements of the lead rule (outside of this protocol) 
therein.\18\ When there is activity that could reintroduce lead into 
the area, repeat sampling would be required every two years.
---------------------------------------------------------------------------

    \18\ Note: Washington DOSH's stakeholder review draft 
contemplates that maintenance and housekeeping staff working in a 
clean area may be doing work covered by the lead rule.
---------------------------------------------------------------------------

    In an area where initial sampling indicates the presence of surface 
lead on worker accessible surfaces at or above 4.3 [mu]g/dm\2\, 
Washington DOSH's proposed protocol would provide for representative 
four-sample testing to demonstrate that ongoing cleaning is sufficient 
to maintain minimal lead levels.
    (24) Should OSHA consider a safe harbor protocol approach similar 
to the Clean Areas protocol described above, which is being considered 
for adoption in Washington State? What aspects of the protocol would be 
beneficial? Are there issues, concerns, or different approaches to a 
``safe harbor'' based on identification of clean areas using surface 
sampling that OSHA should consider?
3. Safe Harbor Protocol for Handling Lead-Containing Articles in Retail 
Settings
    The Washington DOSH stakeholder review draft describes a protocol 
that


could be applied to workers handling lead-containing products for sale 
in retail settings where it is expected that lead will be generally 
well controlled. The Retail Settings protocol would not cover areas of 
a retail facility used for maintenance or repair work that may disturb 
lead-containing materials, and would not cover retail gun shops co-
located with gun ranges. For areas of a retail establishment where lead 
products are not sold, retail employers could selectively apply the 
Clean Areas compliance protocol described above. Under the Retail 
Settings protocol, retail employers could assume that workers are 
covered by the Basic Rules set out in the DOSH stakeholder review 
draft, which include requirements for cleaning practices, hygiene, PPE, 
and provisions for hazard communication and training. Exposure 
assessments would not be required for workers who only handle lead-
containing materials in retail activities including receiving, 
stocking, sales, and housekeeping in the retail activity areas. In 
addition, retail workers would not be covered under the Action Rules 
(which include ongoing exposure monitoring and blood lead testing) or 
the PEL and SPEL Rules (which include requirements covering routine 
control of airborne lead exposure and respirator use, as well as 
heightened requirements in the provisions for cleaning, hygiene, PPE, 
hazard communication and training, exposure monitoring and medical 
surveillance).
    The Washington DOSH stakeholder review draft sets out several 
conditions that must be met by the employer to implement the Retail 
Settings Protocol, such as requiring that lead-containing materials be 
kept segregated from other materials in the establishment and inspected 
when received in the establishment for damage to packaging or the 
product that could release lead; that any manufacturing, repair, 
assembly, or maintenance work involving lead-containing products that 
generates lead aerosols or dust must be performed in a separate area of 
the establishment away from the retail space and must follow protocols 
to prevent lead contamination of the retail space; and that the 
employer must implement specific housekeeping practices (e.g., 
prohibition of dry sweeping, use of wet wiping/mopping and/or HEPA 
filtered vacuums) around lead-containing products or areas where these 
products are stored.
    (25) Should OSHA consider a safe harbor protocol approach similar 
to the Retail Settings Protocol described above, which is being 
considered for adoption in Washington? What aspects of the Protocol 
would be beneficial? Are there issues, concerns, or different 
approaches to a ``safe harbor'' for retail settings that OSHA should 
consider?
4. Safe Harbor Protocol for Office and Residential Settings
    The Washington DOSH stakeholder review draft describes a protocol 
for employees working within a facility that has lead-based paint or 
paint with lead pigments doing work that does not disturb painted 
surfaces. This protocol would, for example, allow the employer to 
assume that workers in office and residential settings are not covered 
by the lead rule unless doing maintenance, remodeling, or repair work. 
Under this protocol, workers occupying a facility for office work are 
not covered by the rule, except when there is an incident causing a 
significant release and exposure to lead; and except for workers doing 
housekeeping work, who would be covered under the Basic Rules 
requirements for cleaning practices, hygiene, PPE, and provisions for 
hazard communication and training.
    To implement this protocol, employers and building owners may 
assume that paint contains lead or conduct screening tests to determine 
lead content. For this protocol, it is expected that there may be minor 
releases due to normal wear and tear and light repair work in the 
facility. The building owner or employer would be required to make 
written documentation of the lead assessment available in the facility 
for occupants, housekeeping workers, and maintenance workers. 
Maintenance or housekeeping staff would be required to make at least 
quarterly visual inspections of the facility for damage to lead paint 
surfaces in occupied areas. Whenever damage is discovered, by 
inspection, occupant report, or other observations, the building owner 
or employer would be required to assess the damage and ensure any 
repair and clean-up is done in a timely manner using methods that limit 
the spread of lead-containing materials (e.g., wet wiping, use of HEPA 
filtered vacuums).
    (26) Should OSHA consider a safe harbor protocol approach similar 
to the Office and Residential Settings protocol described above, which 
is being considered for adoption in Washington? What aspects of the 
protocol would be beneficial? Are there issues, concerns, or different 
approaches to a ``safe harbor'' that OSHA should consider for work in 
office and residential settings that does not involve maintenance, 
remodeling, or repair work?
5. Safe Harbor Protocol for Incidental Lead Paint in Construction/
Renovation, Repair, and Painting (RRP) Work
    The Washington DOSH stakeholder review draft describes a protocol 
for use by contractors and maintenance operations handling lead-
containing paint. This protocol would apply to employers conducting 
incidental lead paint work covered by the EPA renovation, repair and 
painting work rules, or doing similar work. It is not intended for lead 
abatement work as defined by the U.S. Department of Commerce and EPA, 
which would be expected to involve greater levels of exposure than is 
contemplated by this protocol.
    This protocol assumes that: (1) work will be done with hand tools 
or power tools with HEPA filtered dust collection systems; (2) the work 
occurs in residential or similar construction where the primary lead-
containing material is finish paint on wood or wallboard substrates, 
rather than structural steel; (3) contractors conducting this work are 
in compliance with the Department of Commerce and EPA programs and have 
certification from them when required; and (4) training required for 
environmental certification will be supplemented with additional 
information on Washington DOSH rules, including for personal protective 
equipment, respiratory protection, hygiene practices, and work 
practices.
    This protocol would require workers disturbing painted surfaces to 
wear half-face respirators with P100 filters or more protective 
respirators and would allow for workers to request Powered Air 
Purifying Respirators (PAPRs) with HEPA cartridges. The employer must 
implement a respiratory protection program (including identification of 
a respirator program administrator; identification of the respirator 
models and configuration the employer will require for each task 
performed; and the process for medical clearance and fit testing of 
workers) and must provide personal protective equipment including 
either safety glasses/goggles or full face respirators; disposable 
overalls or overalls that are laundered per Washington DOSH rule 
requirements; work boots; disposable shoe covers or dedicated work 
boots that are not worn off the worksite for workers scraping or 
sanding paint; gloves or a glove combination sufficient to prevent lead 
accumulation on the hands and provide necessary protection from cuts or 
other hand hazards; and other personal protective equipment


necessary based on other hazards at the worksite.
    Employers using this protocol would provide workers with workplace-
specific training (see DOSH Stakeholder Review Draft--Action Rules). 
Work covered under the EPA/Department of Commerce rules must be 
conducted by workers meeting the minimum training and certification 
standards of that program, with additional training on worker safety 
issues including health effects of lead, respiratory protection, PPE, 
work practices specific to the worksite, and limits of work practices. 
An on-site competent person must be able to recognize lead-related 
hazards and have authority to take action to correct lead issues at the 
worksite.
    Under this protocol, direct monitoring of employee exposure would 
not be required. The employer could presume that employee exposure to 
airborne lead is no greater than 10 times the proposed PEL of 20 [mu]g/
m\3\ as an eight-hour TWA.\19\ While this presumption is used, the 
employer must meet all requirements of the rule consistent with this 
level of exposure, including: baseline blood lead testing for all 
workers contacting lead-containing coatings \20\ or in the vicinity of 
any work disturbing these materials, follow-up blood lead testing every 
two months for the first six months and every six months thereafter, 
and blood lead testing at the conclusion of work; lead control areas 
around any work disturbing lead-containing coatings; respirator use for 
all workers disturbing lead-containing coatings; and provision of 
appropriate PPE, a clean change area, and hygiene facilities including 
dedicated handwashing, boot cleaning, and showers as necessary.
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    \19\ Employers could choose to conduct exposure assessments to 
determine actual lead exposure levels and tailor their program under 
this protocol as indicated by those results. However, direct 
monitoring of exposure would not be required when not feasible in 
the timeframe of the project. Employers would assume paint in 
structures built before 1978 contains lead in quantities that will 
require controls and PPE as specified in this protocol. Paint could 
be tested by collecting samples for laboratory analysis, use of X-
ray fluorescence, or following EPA/Department of Commerce rules for 
colorimetric testing kits. The protocol would require any paint 
found to potentially contain 5000 ppm lead or more than 1 mg/cm\2\ 
of lead on the surface to be treated as a lead-containing material.
    \20\ ``Lead-containing coatings'' refers to coatings that are 
known or presumed to contain lead.
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    (27) Should OSHA adopt a safe harbor protocol approach similar to 
the protocol described above for incidental lead paint in RRP work that 
is being considered for adoption in Washington? What aspects of the 
protocol would be beneficial? Are there issues, concerns, or different 
approaches to a protocol for RRP work that OSHA should consider?

F. Environmental Effects

    The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 
4321, et seq.), the Council on Environmental Quality (CEQ) regulations 
(40 CFR part 1500), and the Department of Labor (DOL) NEPA Compliance 
Procedures (29 CFR part 11) require that OSHA give appropriate 
consideration to environmental issues and the impacts of proposed 
actions significantly affecting the quality of the human environment. 
OSHA intends to collect written information and data on possible 
environmental impacts that could occur outside of the workplace (e.g., 
exposure to the community through contaminated air/water, contaminated 
waste sites, etc.) if the agency were to revise the existing standard 
for occupational exposure to lead. Such information should include both 
negative and positive environmental effects that could be expected to 
result from guidance or a revised standard. Specifically, OSHA requests 
comments and information on the following:
    (28) What is the potential direct or indirect environmental impact 
(for example, the effect on air and water quality, energy usage, solid 
waste disposal, and land use) from a reduction in BLL triggers or other 
changes to the OSHA lead standards?
    (29) Are there any situations in which reducing lead exposures to 
employees would be inconsistent with meeting environmental regulations?

G. Duplicative, Overlapping, or Conflicting Rules

    This section examines whether there are any duplicative, 
overlapping, or conflicting regulations concerning lead that OSHA 
should be aware of. In your explanation, please explain in detail if 
there are any such concerns of which the agency should be aware.
    (30) Are there any federal regulations that might duplicate, 
overlap, or conflict with modifications to the current lead standards? 
If yes, please identify and explain how they would duplicate, overlap, 
or conflict.
    (31) Are there any federal programs in areas such as defense or 
energy that might be impacted by modifications to the current lead 
standards? If yes, please identify and explain how they would be 
impacted.

H. Questions for Employers on Current Practices

    OSHA requests that commenters, when answering questions regarding 
economic impact, be as specific as possible. For example, if an 
employer is using a modified medical surveillance program, then helpful 
information would include the following: the medical testing necessary; 
the exposure status or types of employees who would receive medical 
testing; the frequency of the testing; and the medical surveillance 
costs. The agency invites comment on the labor time and level of labor 
expertise required to implement proposed methods, even if dollar-cost 
estimates are not available. For discussion of equipment-related costs, 
OSHA requests that commenters estimate relevant factors such as 
purchase price, cost of installation, cost of equipment maintenance, 
cost of training, and expected life of the equipment. Also, please 
discuss the quantitative benefits (e.g., reductions in BLLs) and the 
associated costs (e.g., cost of an exposure control method). Because 
there are some differences between OSHA's lead standards for general 
industry and construction, please specify which standard is applicable 
to your work.
    (32) If you use criteria more stringent than OSHA's requirements 
for conducting blood lead testing on your employees, how do your 
criteria differ from OSHA's requirements?
    (33) If you use criteria more stringent than OSHA's requirements 
for notifying employees of their BLL and ZPP results, how do your 
criteria differ from OSHA's requirements?
    (34) If you use criteria more stringent than OSHA's requirements 
for medical removal protection in your work environment or industry, 
how do your criteria differ from OSHA's requirements? Please include 
the criteria, such as the BLL, for both medical removal and return to 
work status.
    (35) What are your current costs of medical removal per employee 
(where possible, please monetize in terms of dollars per time unit 
(e.g., per month, per year))? Would your company be able to reassign 
the medically removed worker to a job at least at the clerical level 
that the employee would find acceptable? Please include specific 
examples of hourly wages (per job category) for the employee's regular 
occupation and the hourly wages for the medically assigned clerical 
job, if available.
    (36) How many of your employees, over the past 10 years, have been 
removed from lead-exposed work due to elevated BLLs? If possible, 
please submit anonymized examples of employees who were brought into 
the medical removal program, their BLL level at the time of removal, 
and the


time required to bring the BLL level below 40 [mu]g/dL (or an 
alternative specified level).
    (37) Over the past ten years, how many, or what percentage, of your 
employees were removed from lead-exposed work due to elevated BLLs 
exceeding the maximum 18-month time period and were unable to return to 
work?
    (38) OSHA's lead standards set a BLL of below 40 [mu]g/dL (two 
consecutive tests) for return to lead-exposed work for medically 
removed workers. As discussed earlier in this ANPRM, in Section I.A. 
Background; Events Leading to this Action, OSHA is considering lowering 
the BLL for medical removal. If possible, please submit estimated 
increases in the number of affected employees and in costs if the BLL 
for allowing return to work were reduced to a level lower than OSHA's 
current BLL of 40 [mu]g/dL. Please specify the BLL for return to work 
you assume in your estimation.
    (39) How many and what percentage of your employees are currently 
in your medical surveillance program? How many of these employees 
receive BLL testing? How many receive ZPP monitoring?
    (40) What are your current costs of medical surveillance per 
employee? Please include specific examples of resource requirements in 
terms of additional staffing or time commitments (per job category), 
costs for purchase of testing materials (dollar cost per unit), 
expected life of equipment, and costs for energy usage and any other 
additional expenses.
    (41) The OSHA lead standard for general industry requires the 
employer to institute a medical surveillance program for all employees 
who are or may be exposed at or above the AL (30 [mu]g/m\3\) for more 
than 30 days per year. There are three requirements for biological 
monitoring that are triggered by the current AL (30 [mu]g/m\3\):
     At least every 6 months for each employee;
     At least every two months for each employee whose last 
blood lead test indicated a BLL at or above 40 [mu]g/dL. This frequency 
shall continue until two consecutive blood lead tests indicate a BLL 
below 40 [mu]g/dL; and
     At least monthly during the removal period of each 
employee removed from exposure to lead due to an elevated BLL.
    If possible, please discuss and/or submit quantitative estimates of 
the increases in the number of affected employees and in medical 
surveillance costs or other pertinent costs if the AL (30 [mu]g/m\3\) 
were decreased. Please specify the AL you assume in your estimation.
    (42) Have you upgraded engineering controls to reduce airborne 
concentrations of lead in your facility? If yes, please describe the 
controls and whether you observed a subsequent reduction in BLLs. If 
so, did you monitor to what extent workers' BLLs were reduced following 
implementation of upgraded controls? Please provide data, if available, 
on airborne lead concentrations in your facility and on workers' BLLs 
prior to and following the upgrades. Also provide related initial and 
annual engineering control costs of upgraded controls, as well as the 
expected life of the equipment.
    (43) Please describe your control strategies to reduce lead surface 
contamination and the potential for dermal exposure to lead in your 
facility, such as housekeeping procedures, hygiene areas and practices, 
and personal protective clothing and equipment (PPE). Please describe 
such controls, their costs, and explain how well they work and why. To 
what extent were you able to lower the surface levels of lead? Did you 
see a subsequent reduction in employee BLLs? Please provide supporting 
data, if available.
Personal Protective Clothing and Equipment (PPE)
    Employers are required to provide work clothing and equipment if an 
employee is exposed to lead above the PEL or where the possibility of 
skin or eye irritation exists.
    (44) Do you provide PPE in your workplace, including equipment 
providing respiratory protection? If yes, has it reduced BLLs in your 
workers? Please describe the type of PPE that you provide.
    (45) Does your company have triggers for PPE that are different 
from requirements under OSHA's lead standards? Please describe the 
triggers used for providing PPE.
    (46) If your firm purchases clothing and equipment to protect 
employees from lead exposure, please estimate the PPE costs necessary 
to comply with the current OSHA lead standard. Please give costs on a 
per employee basis and at an aggregated level, if available.
    (47) Have you upgraded PPE to reduce worker exposure to lead? If 
yes, please describe the controls and whether you observed a subsequent 
reduction in BLLs. If so, to what extent were workers' BLLs reduced 
following implementation of upgraded PPE, if applicable? Please provide 
data, if available.
Housekeeping
    OSHA's lead standards contain a housekeeping provision that 
requires employers to keep surfaces as free as practicable from lead, 
encourages the use of vacuuming to clean surfaces, limits the use of 
dry sweeping and shoveling, and prohibits using compressed air to clean 
surfaces. Some variation exists between the housekeeping provisions for 
general industry and construction.
    (48) Do you have housekeeping procedures? If yes, please describe.
    (49) Does your company have cleaning criteria specific to surfaces? 
This may include a schedule for cleaning and periodic surface 
cleanliness measurements, specific types of cleaning practices and 
activities, or other activities associated with surface 
decontamination.
    (50) What are your current housekeeping costs to comply with the 
OSHA lead standard? Please provide the amount of time allocated for 
housekeeping costs calculated on an hourly basis.
Hygiene Facilities and Practices
    OSHA's lead standards contain hygiene facilities and practices 
provisions that require employers to provide showers, change rooms, and 
lunchrooms when workers are exposed to lead above the PEL without 
regard to the use of respirators. The employer must also ensure that 
food or beverage is not present or consumed, tobacco products are not 
present or used, and cosmetics are not applied in areas where workers 
are exposed above the PEL. Some variation exists between the hygiene 
facilities and practices provisions for general industry and 
construction.
    (51) Have you provided hygiene facilities or used hygiene practices 
beyond the requirements of OSHA's lead standards? This may include more 
frequent hand washing breaks or providing access and time for showers 
at exposures below the PEL. Please describe how your practices differ 
from requirements in OSHA's lead standards.
    (52) What are your current costs to comply with the hygiene 
provisions of OSHA's lead standards? Please provide the amount of time 
allocated for hygiene costs calculated on an hourly basis.
BLLs and Lead Dust Contamination
    Some federal agencies, such as the U.S. Department of Housing and 
Urban Development (HUD) and the EPA, have established lead dust hazard 
action levels for surfaces (HUD, 2012; EPA 2001). OSHA is interested in

information on using lead dust hazard surface measurements and any 
observed correlation between surface lead dust levels and elevated 
BLLs.
    (53) Have you taken lead dust surface measurements in your work 
environment? If so, what are your procedures and current costs for this 
testing? Please specify the labor and equipment costs for the testing. 
Have you experienced any impediments or limitations when using wipe 
sampling to identify surface contamination with lead? What can be done 
to overcome these barriers?
    (54) If you have taken lead dust surface measurements, are they 
qualitative (presence of lead only) or quantitative? If quantitative, 
do you use lead dust hazard levels established by HUD and EPA? Please 
provide any data you have on quantitative surface contamination 
measurements in your work environment.
    (55) Have you evaluated lead surface contamination to investigate 
elevated employee BLLs in areas where airborne lead exposure was below 
the PEL? If yes, what were your findings?
    (56) Have you taken wipe samples of skin or clothing to identify 
lead contamination? If yes, what were your findings?
    (57) Have you found any correlation between BLLs and lead surface 
contamination, particularly when airborne exposures are below the PEL?
Impact on Small Business Entities
    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), OSHA 
is required to assess the impact of proposed and final rules on small 
entities. OSHA requests that members of the small business community, 
or other parties familiar with regulation of small business, address 
any special circumstances facing small firms in controlling 
occupational exposure to lead.
    (58) How many and what kinds of small businesses or other small 
entities in your industry could be affected by lower protective BLL 
triggers in the OSHA lead standard for general industry? Describe any 
such effects.
    (59) How many and what kinds of small businesses or other small 
entities in your industry could be affected by lower BLL triggers in 
the OSHA lead standard for construction? Describe any such effects.
    (60) Are there special issues or reasons that lower BLL triggers 
are more difficult or costlier to implement in small firms? Please 
describe.
    (61) Are there any reasons why benefits from reducing worker BLLs 
would be different in small firms than in larger firms? With regard to 
potential impacts on small firms, please describe specific concerns 
that OSHA should address and any alternatives that might serve to 
minimize these impacts while meeting the requirements of the OSH Act.

Authority and Signature

    Douglas Parker, 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's Order 8-2020 (Sept. 18, 2020), and 29 CFR part 1911.

    Signed at Washington, DC, on June 21, 2022.
Douglas L. Parker,
Assistant Secretary of Labor for Occupational Safety and Health.

References

Abt Associates (Abt). (2021). Revised Number of BLL Cases and Firms. 
Memorandum. Abt Associates, Division of Health and Environment. 
August 9, 2021.
Adult Blood Lead Epidemiology and Surveillance (ABLES). (2019). 
Elevated Blood Lead Levels (BLL) among Employed Adults--United 
States, 2016.
Adult Blood Lead Epidemiology and Surveillance (ABLES). (2020). 
Tables provided by Rebecca Tsai (NIOSH) to Matt LaPenta (Abt 
Associates).
Adult Blood Lead Epidemiology and Surveillance (ABLES). (2021). BLL 
Reference Guide. Retrieved from: https://www.cdc.gov/niosh/topics/ables/ReferenceBloodLevelsforAdults.html. Accessed on October 7, 
2021.
Agency for Toxic Substance and Disease Registry (ASTDR). (2007). 
Toxicological Profile for Lead. http://www.atsdr.cdc.gov/ToxProfiles/tp13.pdf. Accessed on November 10, 2020.
Agency for Toxic Substance and Disease Registry (ASTDR). (2020). 
Toxicological Profile for Lead. Retrieved from: http://www.atsdr.cdc.gov/ToxProfiles/tp13.pdf. Accessed on November 10, 
2020.
American College of Government Industrial Hygienists (ACGIH). 
(2013). Threshold limit values for chemical substances and physical 
agents and biological exposure indices. American Conference of 
Governmental Industrial Hygienists, Cincinnati, OH.
American College of Occupational and Environmental Medicine (ACOEM). 
(2016). Workplace Lead Exposure: ACOEM Position Statement. JOEM. 
58(12): e371-374.
Association of Occupational and Environmental Clinics (AOEC). 
(2007). Medical Management Guidelines for Lead-Exposed Adults. 
Retrieved from: http://www.aoec.org/documents/positions/MMG_FINAL.pdf. Accessed on November 10, 2020.
California Department of Public Health (CDPH). (2009). Medical 
Guidelines for the Lead-Exposed Worker. Retrieved from: http://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/OLPPP/CDPH%20Document%20Library/medgdln.pdf. Accessed on November 10, 
2020.
California Department of Public Health (CDPH). (2010). Summary of 
CDPH Proposed Changes to the General Industry Lead Standard. 
Retrieved from https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/OLPPP/CDPH%20Document%20Library/LeadStdRecsSummary.pdf. Accessed on 
July 14, 2021.
California Department of Public Health (CDPH). (2011). Background to 
OLPPP's Proposed Changes to the Lead in Construction Standard. 
Retrieved from: https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/OLPPP/CDPH%20Document%20Library/LICStdRecsSummary.pdf. Accessed on 
July 14, 2021.
California Department of Public Health (CDPH). (2013). Occupational 
Lead Poisoning Prevention Program (OLPPP). Retrieved from: https://www.cdph.ca.gov/Programs/CCDPHP/DEODC/OHB/OLPPP/Pages/OLPPP.aspx. 
Accessed on November 10, 2020.
California Department of Public Health (CDPH). (2020a). Table 1. 
Number of California Workers Tested in 2015-2018, by BLL Threshold 
and Industry.
California Department of Public Health (CDPH). (2020b). Table 2. 
Number of California Employers Testing BLLs from 2015-2018, by BLL 
Threshold and Industry.
Centers for Disease Control and Prevention (CDC). (1982.) Centers 
for Disease Control and Prevention (CDC). (1982, March 19). Current 
Trends Blood-Lead Levels in U.S. Population. MMWR. Morbidity and 
Mortality Weekly Reports. Retrieved from: https://www.cdc.gov/mmwr/preview/mmwrhtml/00000225.htm. Accessed on July 14, 2021.
Centers for Disease Control and Prevention, National Notifiable 
Diseases Surveillance system (NNDSS). (2016). Lead, Elevated Blood 
Levels, 2016 Case Definition. Retrieved from: https://ndc.services.cdc.gov/case-definitions/lead-elevated-blood-levels-2016/. Accessed on November 10, 2020.
Council on State and Territorial Epidemiologists (CSTE). (2015). 
Public Health Reporting and National Notification for Elevated Blood 
Lead Levels. 15-EH-01.
Environmental Protection Agency (U.S. EPA). (2013). Final Report: 
Integrated Science Assessment for Lead. U.S. Environmental 
Protection Agency, Washington, DC, EPA/600/R-10/075F, 2013. 
Retrieved from: https://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=255721. Accessed November 23, 2021.
Grandjean P, Jorgensen PJ, Viskum S. (1991). Temporal and inter-
individual variation


in erythrocyte zinc-protoporphyrin in lead exposed workers. Br J Ind 
Med. 94: 111-115.
Hu H, Shih R, Rothenberg S, Schwartz BS. (2007). The Epidemiology of 
Lead Toxicity in Adults: Measuring Dose and Consideration of Other 
Methodologic Issues. Environ Health Perspect. 115: 455-462.
Kosnett MJ, Wedeen RP, Rothenberg SJ, Hipkins KL, Materna BL, 
Schwartz BS, Hu H, Woolf A. (2007). Recommendations for medical 
management of adult lead exposure. Environ Health Perspect. 115: 
463-471.
Martin CJ, Werntz CL, Ducatman AM. (2004). The interpretation of 
zinc protoporphyrin changes in lead intoxication: a case report and 
review of the literature. Occup Med. 54 (8): 587-591.
Michigan Occupational and Environmental Medicine Association 
(MOEMA). (2019). MOEMA Update, Volume 19, Issue 1. Retrieved from: 
http://www.moema.org/files/MOEMA_UPDATE_SUMMER_2019.pdf.
National Institute for Occupational Safety and Health (NIOSH). 
(1995). Report to Congress on Workers' Home Contamination Study 
Conducted Under the Workers' Family Protection Act (29 U.S.C. 671a). 
Retrieved from: https://www.cdc.gov/niosh/docs/95-123/default.html. 
Accessed on November 23, 2021.
National Institute for Occupational Safety and Health (NIOSH). 
(2016). ABLES Data Summaries (2016). Retrieved from: https://www.cdc.gov/niosh/topics/ables/data.html. Accessed on November 10, 
2020.
National Institute for Occupational Safety and Health (NIOSH). 
(2021). Understanding Blood Lead Levels (February 2021). Retrieved 
from: https://www.cdc.gov/niosh/topics/ables/ReferenceBloodLevelsforAdults.html. Accessed on November 10, 2020.
National Institute for Occupational Safety and Health (NIOSH). 
(2018). Request for Information About Inorganic Lead (CAS No. 7439-
92-1). August 2018. Retrieved from: https://www.cdc.gov/niosh/docket/review/docket315/pdfs/315-FRN-2018-18019.pdf. Accessed on 
July 14, 2021.
National Research Council (NRC). (2013). Potential Health Risks to 
DOD Firing-Range Personnel from Recurrent Lead Exposure. Committee 
on Potential Health Risks from Recurrent Lead Exposure of DOD Firing 
Range Personnel Committee on Toxicology Board on Environmental 
Studies and Toxicology Division on Earth and Life Studies; National 
Research Council of the National Academies. The National Academies 
Press, Washington, DC.
National Toxicology Program (NTP). (2012). NTP Monograph: Health 
effects of low-level lead. Retrieved from: https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf. Accessed on 
November 10, 2020.
Occupational Safety and Health Administration (OSHA). (2007). 
Regulatory Review of 29 CFR 1926.62 lead in Construction. August 
2007. Retrieved from: https://www.osha.gov/dea/lookback/lead-construction-review.html. Accessed on November 10, 2020.
Occupational Safety and Health Administration (OSHA). (2008). OSHA 
Instruction, National Emphasis Program--Lead. Directive number CPL 
03-00-009. August 14, 2008. Retrieved from: https://www.osha.gov/sites/default/files/enforcement/directives/CPL_03-00-0009.pdf. 
Accessed on November 10, 2020.
Occupational Safety and Health Administration (OSHA). (2013). 
Memorandum. Expanded Targeting of Establishments Under the Lead NEP. 
November 2013. Retrieved from: https://www.osha.gov/laws-regs/standardinterpretations/2013-11-25. Accessed on July 14, 2021.
Occupational Safety and Health Administration (OSHA). (2018). 
Memorandum. [De Minimis] Violation Notices: Blood Laboratory 
Proficiency Testing and Approval. Retrieved from: https://www.osha.gov/laws-regs/standardinterpretations/2018-10-01. Accessed 
on July 14, 2021.
Occupational Safety and Health Administration (OSHA). (2020a). Lead 
Exposure--Table 2--Industry Group Profile (Subcategory) OSHA 
Information System (OIS) Personal Sampling Data for Lead (2014-
2018). Salt Lake Technical Center. Retrieved from: https://www.osha.gov/lead/industry-group-profile. Accessed on November 10, 
2020.
Occupational Safety and Health Administration (OSHA). (2020b). OSHA 
Enforcement Data, Inspection. Retrieved from: https://enforcedata.dol.gov/views/data_summary.php. Accessed on April 3, 
2020.
Occupational Safety and Health Administration (OSHA). (2020c). OSHA 
Enforcement Data, Violation. Retrieved from: https://enforcedata.dol.gov/views/data_summary.php. Accessed on April 3, 
2020.
Office of Environmental Health Hazard Assessment (OEHHA). (2014). 
California Environmental Protection Agency; (2014). Estimating 
Workplace Air and Worker Blood Lead Concentration using an Updated 
Physiologically-based Pharmacokinetic (PBPK) Model. Retrieved from: 
https://oehha.ca.gov/air/document/oehha-presentation-pbpk-model-blood-lead-and-worker-exposure. Accessed on July 12, 2021.
Payne S, et al. (2017). Blood Lead Levels in California Workers: 
Data Reported to the Occupational Blood Lead Registry, 2012-2014. 
Richmond, CA, California Department of Public Health, Occupational 
Health Branch.
Schwartz BS, Hu H. (2007). Adult lead exposure: time for change. 
Environ Health Perspect. 115(3): 451-454.
Shih RA, Hu H, Weisskopf MG, Schwartz BS. (2007). Environ Health 
Perspect. 115(3): 483-492.
U.S. Census Bureau, 2017, Statistics of US Businesses, Program 
Glossary. Available at: https://www.census.gov/programs-surveys/susb/about/glossary.html.
U.S. Department of Defense (DOD). (2018.) DoD 6055.05-M. 
Occupational Medical Examinations and Surveillance Manual, 
Incorporating Change 3, August 31, 2018.
U.S. Department of Health and Human Services (HHS). (2022). Fourth 
national report on human exposure to environmental chemicals, 
updated tables, March 2022, volume one. Retrieved from: https://www.cdc.gov/exposurereport/data_tables.html. Accessed April 25, 
2022.
U.S. Department of Housing and Urban Development (HUD). (2012). 
Guidelines for the Evaluation and Control of Lead-Based Paint 
Hazards in Housing (2012 Edition). Retrieved from: https://www.hud.gov/program_offices/healthy_homes/lbp/hudguidelines. 
Accessed on November 10, 2020.

Appendix A



                     Table 1--Summary of Annual Number of Firms With BLL Tests and Cases \1\
----------------------------------------------------------------------------------------------------------------
                                     Estimated               Estimated number of firms with BLL cases
                                     number of   ---------------------------------------------------------------
                                    firms where
    NAICS      NAICS description     employees                                                    BLL >= medical
                                    receive BLL       BLL >=5        BLL >=10        BLL >=25       removal BLL
                                       tests                                                            \2\
----------------------------------------------------------------------------------------------------------------
1151.........  Support                         2               1               0               0               0
                Activities for
                Crop Production.
2122.........  Metal Ore Mining.             466              78              36              11               0
2123.........  Nonmetallic                    17               2               0               0               0
                Mineral Mining
                and Quarrying.
2131.........  Support                        35               5               0               0               0
                Activities for
                Mining.
2211.........  Electric Power                 25              22              22              10               0
                Generation,
                Transmission and
                Distribution.
2212.........  Natural Gas                   138              19              11               2               0
                Distribution.


 
2213.........  Water, Sewage and               9               9               0               0               0
                Other Systems.
2361.........  Residential                   769             145              83              37               2
                Building
                Construction.
2362.........  Nonresidential                864             323             204              67               9
                Building
                Construction.
2371.........  Utility System                 87              50              36              10               1
                Construction.
2373.........  Highway, Street,              386             136              91              43               4
                and Bridge
                Construction.
2379.........  Other Heavy and                51              10              10               8               1
                Civil
                Engineering
                Construction.
2381.........  Foundation,                   251             171              95              11               1
                Structure, and
                Building
                Exterior
                Contractors.
2382.........  Building                      488             132              58              31               4
                Equipment
                Contractors.
2383.........  Building                    2,746             655             452             199              34
                Finishing
                Contractors.
2389.........  Other Specialty             1,305             354             227              47               9
                Trade
                Contractors.
2399.........  Construction                  516              86              25              25               0
                (Specific
                industry
                unknown).
3231.........  Printing and                  146              20              11               2               0
                Related Support
                Activities.
3241.........  Petroleum and                  11              11               0               0               0
                Coal Products
                Manufacturing.
3251.........  Basic Chemical                 42              20              11               2               0
                Manufacturing.
3252.........  Resin, Synthetic              175              25              13               3               0
                Rubber, and
                Artificial and
                Synthetic Fibers
                and Filaments
                Manufacturing.
3255.........  Paint, Coating,                38              21              12               2               0
                and Adhesive
                Manufacturing.
3259.........  Other Chemical                158              22              12               2               0
                Product and
                Preparation
                Manufacturing.
3271.........  Clay Product and               99              50              27               5               0
                Refractory
                Manufacturing.
3272.........  Glass and Glass             5,156             715             398             113               2
                Product
                Manufacturing.
3279.........  Other Nonmetallic              12               2               0               0               0
                Mineral Product
                Manufacturing.
3311.........  Iron and Steel                 99              13              13              13               1
                Mills and
                Ferroalloy
                Manufacturing.
3312.........  Steel Product                 184              26              14               3               0
                Manufacturing
                from Purchased
                Steel.
3314.........  Nonferrous Metal            1,431             224             189             187              13
                (except
                Aluminum)
                Production and
                Processing.
3315.........  Foundries........           1,103             152             102              28               1
3323.........  Architectural and             994             142              91              44               2
                Structural
                Metals
                Manufacturing.
3324.........  Boiler, Tank, and             261              38              23               7               0
                Shipping
                Container
                Manufacturing.
3325.........  Hardware                      166              23              13               2               0
                Manufacturing.
3327.........  Machine Shops;                 53              15              15              14               0
                Turned Product;
                and Screw, Nut,
                and Bolt
                Manufacturing.
3328.........  Coating,                      256              39              22              10               0
                Engraving, Heat
                Treating, and
                Allied
                Activities.
3329.........  Other Fabricated            1,100             187             154              46               1
                Metal Product
                Manufacturing.
3333.........  Commercial and                133              19              10               2               0
                Service Industry
                Machinery
                Manufacturing.
3336.........  Engine, Turbine,               17              17               0               0               0
                and Power
                Transmission
                Equipment
                Manufacturing.
3339.........  Other General                  65               9               9               2               0
                Purpose
                Machinery
                Manufacturing.
3341.........  Computer and                    6               1               0               0               0
                Peripheral
                Equipment
                Manufacturing.
3342.........  Communications                146              31              17               3               0
                Equipment
                Manufacturing.
3343.........  Audio and Video                 4               0               0               0               0
                Equipment
                Manufacturing.
3344.........  Semiconductor and             323              37              25               9               1
                Other Electronic
                Component
                Manufacturing.
3345.........  Navigational,                 394              72              37              11               0
                Measuring,
                Electromedical,
                and Control
                Instruments
                Manufacturing.
3359.........  Other Electrical              851             165             136             136              24
                Equipment and
                Component
                Manufacturing.
3363.........  Motor Vehicle                 994             142              89              33               2
                Parts
                Manufacturing.
3364.........  Aerospace Product             427              96              40              21               1
                and Parts
                Manufacturing.
3366.........  Ship and Boat                  23              23              13              13               0
                Building.
3369.........  Other                           9               8               0               0               0
                Transportation
                Equipment
                Manufacturing.
3399.........  Other                         296              53              53              12               0
                Miscellaneous
                Manufacturing.
4231.........  Motor Vehicle and             305              57              31               6               0
                Motor Vehicle
                Parts and
                Supplies
                Merchant
                Wholesalers.
4236.........  Household                     330              46              25               6               0
                Appliances and
                Electrical and
                Electronic Goods
                Merchant
                Wholesalers.


 
4237.........  Hardware, and                 130              18              10               2               0
                Plumbing and
                Heating
                Equipment and
                Supplies
                Merchant
                Wholesalers.
4238.........  Machinery,                     12               2               0               0               0
                Equipment, and
                Supplies
                Merchant
                Wholesalers.
4239.........  Miscellaneous                 629             141             141             130               3
                Durable Goods
                Merchant
                Wholesalers.
4244.........  Grocery and                     7               1               0               0               0
                Related Product
                Merchant
                Wholesalers.
4247.........  Petroleum and                  14               2               0               0               0
                Petroleum
                Products
                Merchant
                Wholesalers.
4413.........  Automotive Parts,             136              19              10               2               0
                Accessories, and
                Tire Stores.
4441.........  Building Material             134              19              10               2               0
                and Supplies
                Dealers.
4451.........  Grocery Stores...               8               1               0               0               0
4483.........  Jewelry, Luggage,             125              18              10               2               0
                and Leather
                Goods Stores.
4511.........  Sporting Goods,               780             109              60              11               0
                Hobby, and
                Musical
                Instrument
                Stores.
4821.........  Rail                            8               8               8               2               0
                Transportation.
4841.........  General Freight                13              13               0               0               0
                Trucking.
4842.........  Specialized                    12               3               0               0               0
                Freight Trucking.
4851.........  Urban Transit                   3               3               3               2               0
                Systems.
4881.........  Support                        21              21              21              12               0
                Activities for
                Air
                Transportation.
4883.........  Support                       306              45              25               6               0
                Activities for
                Water
                Transportation.
4884.........  Support                       183              11              10               3               0
                Activities for
                Road
                Transportation.
4911.........  Postal Service...               0               0               0               0               0
4921.........  Couriers and                    8               1               0               0               0
                Express Delivery
                Services.
5111.........  Newspaper,                    131              18              10               2               0
                Periodical,
                Book, and
                Directory
                Publishers.
5173.........  Wired and                      10               1               0               0               0
                Wireless
                Telecommunicatio
                ns Carriers.
5182.........  Data Processing,                0               0               0               0               0
                Hosting, and
                Related Services.
5211.........  Monetary                      131              18              10               2               0
                Authorities-
                Central Bank.
5242.........  Agencies,                      10               3               0               0               0
                Brokerages, and
                Other Insurance
                Related
                Activities.
5311.........  Lessors of Real                 7               4               0               0               0
                Estate.
5313.........  Activities                    231              32              18               3               0
                Related to Real
                Estate.
5323.........  General Rental                 53              19              10               4               0
                Centers.
5324.........  Commercial and                113              16               9               2               0
                Industrial
                Machinery and
                Equipment Rental
                and Leasing.
5413.........  Architectural,                218              88              65              12               0
                Engineering, and
                Related Services.
5415.........  Computer Systems              121              17               9               2               0
                Design and
                Related Services.
5416.........  Management,                   153              53              19               7               0
                Scientific, and
                Technical
                Consulting
                Services.
5417.........  Scientific                     12              12               8               2               0
                Research and
                Development
                Services.
5419.........  Other                         125              18              10               2               0
                Professional,
                Scientific, and
                Technical
                Services.
5611.........  Office                        118              17               9               2               0
                Administrative
                Services.
5613.........  Employment                    119              45              34              10               0
                Services.
5614.........  Business Support               12               2               0               0               0
                Services.
5616.........  Investigation and             395              66              36               7               0
                Security
                Services.
5617.........  Services to                   127              18              10               2               0
                Buildings and
                Dwellings.
5621.........  Waste Collection.             102              35              19               4               0
5622.........  Waste Treatment                39              28              22               6               0
                and Disposal.
5629.........  Remediation and             1,663             739             494             190               4
                Other Waste
                Management
                Services.
6111.........  Elementary and                  4               3               3               2               0
                Secondary
                Schools.
6112.........  Junior Colleges..             146              20              11               2               0
6113.........  Colleges,                      11               8               0               0               0
                Universities,
                and Professional
                Schools.
6115.........  Technical and                 714             100              46              10               0
                Trade Schools.
6116.........  Other Schools and             745             111              61              19               0
                Instruction.
6211.........  Offices of                      9               9               0               0               0
                Physicians.
6214.........  Outpatient Care                 9               5               0               0               0
                Centers.
6215.........  Medical and                     9               9               0               0               0
                Diagnostic
                Laboratories.
6219.........  Other Ambulatory                9               4               4               4               0
                Health Care
                Services.
6221.........  General Medical                10               4               0               0               0
                and Surgical
                Hospitals.


 
6222.........  Psychiatric and                12              12               0               0               0
                Substance Abuse
                Hospitals.
6232.........  Residential                    15              15               0               0               0
                Intellectual and
                Developmental
                Disability,
                Mental Health,
                and Substance
                Abuse Facilities.
6241.........  Individual and                 51              18              10               2               0
                Family Services.
6243.........  Vocational                     10               1               0               0               0
                Rehabilitation
                Services.
7115.........  Independent                     3               1               0               0               0
                Artists,
                Writers, and
                Performers.
7121.........  Museums,                      309              50              30              21               0
                Historical
                Sites, and
                Similar
                Institutions.
7131.........  Amusement Parks                 3               3               0               0               0
                and Arcades.
7139.........  Other Amusement             6,656            1024             619             205               9
                and Recreation
                Industries.
8111.........  Automotive Repair           3,333             553             310              72               1
                and Maintenance.
8112.........  Electronic and                 29              17              17              11               0
                Precision
                Equipment Repair
                and Maintenance.
8113.........  Commercial and                 79              14              10               6               0
                Industrial
                Machinery and
                Equipment
                (except
                Automotive and
                Electronic)
                Repair and
                Maintenance.
8114.........  Personal and                  953             133              71              34               1
                Household Goods
                Repair and
                Maintenance.
8122.........  Death Care                    145              20              11               2               0
                Services.
8131.........  Religious                      12               3               0               0               0
                Organizations.
8139.........  Business,                     488              72              50              28               1
                Professional,
                Labor,
                Political, and
                Similar
                Organizations.
9211.........  Executive,                      0               0               0               0               0
                Legislative, and
                Other General
                Government
                Support.
9221.........  Justice, Public                 0               0               0               0               0
                Order, and
                Safety
                Activities.
9231.........  Administration of               0               0               0               0               0
                Human Resource
                Programs.
9241.........  Administration of               0               0               0               0               0
                Environmental
                Quality Programs.
9251.........  Administration of               0               0               0               0               0
                Housing
                Programs, Urban
                Planning, and
                Community
                Development.
9261.........  Administration of               0               0               0               0               0
                Economic
                Programs.
9281.........  National Security               0               0               0               0               0
                and
                International
                Affairs.
----------------------------------------------------------------------------------------------------------------
              Total                       44,144           8,611           5,302           2,087             137
----------------------------------------------------------------------------------------------------------------
\1\ The Census Bureau defines an establishment as a single physical location at which business is conducted or
  services or industrial operations are performed. The Census Bureau defines a business firm or entity as a
  business organization consisting of one or more domestic establishments in the same state and industry that
  are specified under common ownership or control. The firm and the establishment are the same for single-
  establishment firms. For each multi-establishment firm, establishments in the same industry within a state
  will be counted as one firm; the firm employment and annual payroll are summed from the associated
  establishments.
\2\ Medical removal levels are BLL >=50 [micro]g/dL in Construction (NAICS 23) and BLL >=60 [micro]g/dL in
  General Industry.

[FR Doc. 2022-13696 Filed 6-27-22; 8:45 am]
BILLING CODE 4510-26-P