[Federal Register Volume 89, Number 98 (Monday, May 20, 2024)]
[Rules and Regulations]
[Pages 44144-44461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08568]
Vol. 89
Monday,
No. 98
May 20, 2024
Part IV
Department of Labor
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Occupational Safety and Health Administration
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29 CFR Part 1910
Hazard Communication Standard; Final Rule
Federal Register / Vol. 89, No. 98 / Monday, May 20, 2024 / Rules and
Regulations
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2019-0001]
RIN 1218-AC93
Hazard Communication Standard
AGENCY: Occupational Safety and Health Administration (OSHA), Labor.
ACTION: Final rule.
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SUMMARY: OSHA is amending the Hazard Communication Standard (HCS) to
conform to the United Nations' Globally Harmonized System of
Classification and Labelling of Chemicals (GHS), primarily Revision 7
(Rev. 7), address issues that arose during the implementation of the
2012 update to the HCS, and provide better alignment with other U.S.
agencies and international trading partners, while enhancing the
effectiveness of the standard. Consistent with Executive Order 13563
and the Regulatory Flexibility Act, which call for assessment and,
where appropriate, modification and improvement of existing rules, OSHA
has reviewed the existing HCS. The agency has determined that the
revisions in this final rule will enhance the effectiveness of the HCS
by ensuring employees are appropriately apprised of the chemical
hazards to which they may be exposed, thus reducing the incidence of
chemical-related occupational illnesses and injuries. The modifications
to the standard include revised criteria for classification of certain
health and physical hazards, revised provisions for updating labels,
new labeling provisions for small containers, new provisions related to
trade secrets, technical amendments related to the contents of safety
data sheets (SDSs), and related revisions to definitions of terms used
in the standard.
DATES: This final rule is effective July 19, 2024. The incorporation by
reference of certain publications listed in this final rule is approved
by the Director of the Federal Register as of July 19, 2024. The
incorporation by reference of certain other publications listed in the
rule was approved by the Director as of July 15, 2019.
ADDRESSES: In compliance with 28 U.S.C. 2112(a), the agency designates
Edmund C. Baird, Associate Solicitor for Occupational Safety and
Health, Office of the Solicitor, Room S-4004, U.S. Department of Labor,
200 Constitution Avenue NW, Washington, DC 20210, as the recipient of
petitions for review of this final rule.
Docket: To read or download comments or other material in the
docket, go to Docket No. OSHA-2019-0001 at www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through that website. All comments and
submissions, including copyrighted material, are available for
inspection through the OSHA Docket Office. Documents submitted to the
docket by OSHA or stakeholders are assigned document identification
numbers (Document ID) for easy identification and retrieval. The full
Document ID is the docket number plus a unique four-digit code. For
example, the Document ID number for the 2021 HCS Notice of Proposed
Rulemaking (NPRM) is OSHA-2019-0001-0258. Some Document ID numbers also
include one or more attachments.
When citing exhibits in the docket, OSHA includes the term
``Document ID'' followed by the last four digits of the Document ID
number. For example, document OSHA-2019-0001-0258 would appear as
Document ID 0258. Citations may also include the attachment number
(designated ``Att.'') or other attachment identifier, if applicable,
page numbers (designated ``p.'', or ``Tr.'' for pages from a hearing
transcript), and in a limited number of cases a footnote number
(designated ``Fn.'').
This information can be used to search for a supporting document in
the docket at 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:
For press inquiries: Contact Frank Meilinger, Director, Office of
Communications, Occupational Safety and Health Administration, U.S.
Department of Labor; telephone: (202) 693-1999; email:
meilinger.francis2@dol.gov.
For general information and technical inquiries: Contact Tiffany
DeFoe, Director, Office of Chemical Hazards--Metals, Directorate of
Standards and Guidance, Occupational Safety and Health Administration,
U.S. Department of Labor; telephone: (202) 693-1950; email:
defoe.tiffany@dol.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Introduction
III. Events Leading to the Revised Hazard Communication Standard
IV. Need and Support for the Revised Hazard Communication Standard
V. Pertinent Legal Authority
VI. Final Economic Analysis and Regulatory Flexibility Analysis
VII. OMB Review Under the Paperwork Reduction Act of 1995
VIII. Federalism
IX. State Plans
X. Unfunded Mandates Reform Act
XI. Protecting Children From Environmental Health and Safety Risks
XII. Environmental Impacts
XIII. Consultation and Coordination With Indian Tribal Governments
XIV. Summary and Explanation of the Final Rule
XV. Issues and Options Considered
List of Subjects in 29 CFR Part 1910
Authority and Signature
I. Executive Summary
The Globally Harmonized System of Classification and Labelling of
Chemicals (GHS) has been implemented around the world. In 2012, OSHA
revised its Hazard Communication Standard (HCS), 29 CFR 1910.1200, to
align with Revision 3 (Rev. 3) of the GHS (77 FR 17574). However, the
GHS is updated with improvements and clarifications every two years.
This rulemaking amends the HCS primarily to align with Revision 7 (Rev.
7) of the GHS, published in 2017, where appropriate. OSHA is also
finalizing updates to address specific issues that have arisen since
the 2012 rulemaking and to provide better alignment with other U.S.
agencies and international trading partners, while enhancing the
effectiveness of the standard. This action is consistent with Executive
Order 13563, ``Improving Regulation and Regulatory Review'' (January
18, 2011), and the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
which require retrospective analysis of rules that may be out-of-date,
ineffective, or excessively burdensome.
OSHA is required by the Occupational Safety and Health Act of 1970
(OSH Act) (29 U.S.C. 651 et seq.) to assure, as far as possible, safe
and healthful working conditions for workers. As part of this effort,
OSHA first promulgated the HCS in 1983 to provide a standardized
approach to workplace hazard communication associated with exposure to
hazardous chemicals. The HCS requires chemical manufacturers or
importers to classify the hazards of chemicals they produce or import.
It also requires all employers to provide information to their
employees about the hazardous chemicals to which they are exposed, by
means of a hazard communication program, labels and other forms of
warning, safety data sheets (SDSs), and information and training. This
final rule
does not change the fundamental structure of the HCS.
OSHA has determined that the amendments to the HCS contained in
this final rule enhance the effectiveness of the standard by ensuring
that employees are appropriately apprised of the chemical hazards to
which they may be exposed. The modifications to the standard include
revised criteria for classification of certain health and physical
hazards to better capture and communicate the hazards to downstream
users; revised provisions for labels (including provisions addressing
the labeling of small containers and the relabeling of chemicals that
have been released for shipment); amendments related to the contents of
SDSs; and new provisions relating to concentrations or concentration
ranges being claimed as trade secrets.
Additionally, in accordance with Executive Orders 12866 and 13563,
the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act (2
U.S.C. 1501 et seq.), OSHA has prepared a Final Economic Analysis
(FEA), including a Final Regulatory Flexibility Analysis Certification,
for the final modifications to the HCS (see the full FEA in Section VI
of this notice). Supporting materials prepared by OSHA, such as cost-
estimate spreadsheets, are available in the public docket for this
rulemaking, Docket ID OSHA-2019-0001, through www.regulations.gov.
In the FEA, OSHA estimates that, annualized at a 7 percent discount
rate, the final rule would result in net cost savings of $29.8 million
per year, as shown in Table ES-1 below (a summary of annualized costs
by affected industry). Annualized at a 3 percent discount rate, OSHA
estimates that the final rule would result in net cost savings of $30.7
million per year. OSHA also expects that the final revisions to the HCS
will result in modest improvements in worker health and safety above
those already being achieved under the current HCS, but the agency was
unable to quantify the magnitude of these health and safety benefits
(see Section VI.D: Health and Safety Benefits and Unquantified Positive
Economic Effects).
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II. Introduction
This preamble includes a review of the events leading to the final
rule, a discussion of the reasons why OSHA finds these modifications to
the HCS necessary, the final economic analysis and regulatory
flexibility analysis for the standard, and an explanation of the
specific revisions OSHA is making to the standard.
Section XIV: Summary and Explanation of the Final Rule is organized
by paragraph of regulatory text affected by this update, followed by
the appendices to the regulatory text. Stakeholders can examine the
redline strikeout of the regulatory text (changes from 2012 HCS to this
final) at OSHA's HCS web page (https://www.osha.gov/dsg/hazcom/) to
view all of the changes to the 2012 HCS made in this final rule.
III. Events Leading to the Revised Hazard Communication Standard
OSHA first promulgated the HCS in 1983, covering only the chemical
manufacturing industry (48 FR 53280). The purpose of the standard was
to provide a standardized approach for communicating workplace hazards
associated with exposure to hazardous chemicals. OSHA updated the HCS
in 1987 to expand coverage to all industries where workers are exposed
to hazardous chemicals (52 FR 31852). In 1994, OSHA promulgated an
additional update to the HCS with technical changes and amendments
designed to ensure better comprehension and greater compliance with the
standard (59 FR 6126). In adopting the original HCS in 1983, the agency
noted the benefits of an internationally harmonized chemical hazard
communication standard (48 FR 53287), and actively participated in
efforts to develop one over the subsequent decades. In 2012, the agency
officially harmonized the HCS with the third revision of the GHS
(Document ID 0085) (77 FR 17574).
On February 16, 2021, OSHA published a Notice of Proposed
Rulemaking (NPRM) to modify the HCS, to bring it into alignment with
the seventh revision of the GHS (Document ID 0060) (86 FR 9576), to
address specific issues that have arisen since the 2012 rulemaking, and
to provide better alignment with other U.S. agencies and international
trading partners. On September 21-23, 2021, the agency held an informal
public hearing to gather additional input from interested stakeholders.
OSHA received more than 170 public submissions (e.g., written comments,
exhibits, and briefing materials) during the public comment period.
This rulemaking finalizes the amendments proposed in 2021 with
modifications based on stakeholder input through the public comment
process.
The HCS requires periodic revision to maintain consistency with the
GHS and incorporate the progression of scientific principles and best
approaches for classification and communication of workplace hazards
related to hazardous chemical exposure. Several international and
domestic activities have impacted the direction of the HCS and led to
the updates of this rule, including international negotiations at the
United Nations (UN), coordination with other U.S. agencies, OSHA's
participation in the U.S.-Canada Regulatory Cooperation Council (RCC)
with Health Canada, and information OSHA has received from HCS
stakeholders. Below, the agency provides information on the events that
have occurred since promulgation of the 2012 HCS, with additional
information on the development of the GHS and its relationship to the
HCS, and explains the impetus for this rule.
A. International Events Affecting the Standard
The evolution of what was to become the GHS had its early
beginnings with the work started in 1956 by the UN Economic and Social
Council Committee of Experts on the Transport of Dangerous Goods (TDG)
and continued in the 1990s through the UN Conference on Environment and
Economic Development (UNCED), the UN International Labour Organization
(ILO), and the Organization for Economic Cooperation and Development
(OECD) (Document ID 0053). The overarching goal was to provide an
internationally harmonized system to convey information to workers,
consumers, and the general public on the physical, health, and
environmental effects of hazardous chemicals across the globe, as well
as to provide a foundation for the safe management of those chemicals.
Finalized by the UN in 2002, the GHS is intended to harmonize
elements of hazard communication, including SDSs and labels, by
providing a unified classification system of chemicals based on their
physical and health-related hazards. The GHS is updated and revised
every two years based on information and experience gained by
regulatory agencies, industry, and non-governmental organizations
(Document ID 0052).
Since OSHA's adoption of Rev. 3 in 2012, the GHS has been updated
six times; the latest revision, Rev. 9, was published in July 2021
(https://unece.org/transport/standards/transport/dangerous-goods/ghs-rev9-2021). Updates to the GHS in Rev. 4 (2011) included changes to
hazard categories for chemically unstable gases and non-flammable
aerosols and updates to, and clarification of, precautionary statements
(Document ID 0240). Changes in Rev. 5 (2013) included a new test method
for oxidizing solids; miscellaneous provisions intended to further
clarify the criteria for some hazard classes (skin corrosion/
irritation, severe eye damage/irritation, and aerosols) and to
complement the information to be included in the SDS; revised and
simplified classification and labeling summary tables; a new
codification system for hazard pictograms; and revised precautionary
statements (Document ID 0241). Rev. 6 (2015) included a new hazard
class for desensitized explosives and a new hazard category for
pyrophoric gases; miscellaneous provisions intended to clarify the
criteria for some hazard classes (explosives, specific target organ
toxicity following single exposure, aspiration hazard, and hazardous to
the aquatic environment); additional information to be included in
Section 9 of the SDS; revised precautionary statements; and a new
example in Annex 7 addressing labelling of small packages (Document ID
0197). Changes in Rev. 7 (2017) included revised criteria for
categorization of flammable gases within Category 1; miscellaneous
amendments intended to clarify the definitions of some health hazard
classes; additional guidance regarding the coverage of Section 14 of
the SDS (which is non-mandatory under the HCS); and a new example in
Annex 7 addressing labeling of small packages with fold-out labels
(Document ID 0094). Rev. 8 (2019) added a table for the classification
criteria versus only relying on the decision logics for chemicals under
pressure; minor changes to precautionary statements for skin irritation
and serious eye damage; new provisions for use of non-animal test
methods for the skin irritation/corrosion hazard class; and new
precautionary pictograms for ``keep out of reach of children''
(Document ID 0065). Rev. 9 (2021) included changes to chapter 2.1 to
better address explosive hazards when not in transport, revisions to
decision logics, revisions to Annex 1--classification and labeling
summary tables, revisions to precautionary statements, and updates to
OECD test guidelines in Annexes 9 and 10 (https://unece.org/transport/
standards/
transport/dangerous-goods/ghs-rev9-2021).
I. U.S. Participation at the United Nations and Interagency
Coordination
OSHA leads the U.S. Interagency GHS Coordinating Group, an
interagency group that serves as a U.S. delegation to the UN
(``Interagency Group''). The Interagency Group works to ensure that
modifications to the GHS continue to reflect U.S. agencies' key
priorities and do not conflict with U.S. hazard communication and
associated requirements. The group meets regularly to discuss issues
related to the domestic implementation of the GHS, as well as
international work being done at the UN Sub-Committee of Experts on the
GHS (UNSCEGHS). It consists of representatives from OSHA, the
Department of State, the Department of Transportation (DOT), the
Environmental Protection Agency (EPA), the U.S. Coast Guard, the
Consumer Product Safety Commission (CPSC), the Department of Energy
(DOE), the Department of Defense (DOD), the Bureau of Alcohol, Tobacco,
Firearms and Explosives (ATF), and other agencies as appropriate. To
date, OSHA is the only U.S. agency to have implemented the GHS,
although CPSC regulations contain elements of the GHS (e.g.,
precautionary statements) (Document ID 0175). EPA (which initiated the
U.S. working group) finalized changes to its regulations governing
significant new uses of chemical substances under the Toxic Substances
Control Act (TSCA) that would align with the HCS and the GHS as well as
with OSHA's respiratory protection standard (29 CFR 1910.134) and
National Institute for Occupational Safety and Health (NIOSH)
respirator certification requirements (87 FR 39756).
II. U.S.-Canada Coordination
An additional international activity impacting the HCS is OSHA's
participation in the RCC. The RCC was established in 2011 to promote
economic growth, job creation, and other benefits through increased
regulatory coordination and transparency between the U.S. and Canada
(Document ID 0057; 0199). In June 2018, U.S.-Canada RCC principles were
reaffirmed through a memorandum of understanding between the U.S.
Office of Information and Regulatory Affairs (OIRA) within the White
House Office of Management and Budget (OMB) and the Treasury Board of
Canada. Since the RCC's inception, OSHA and Health Canada, Canada's
corresponding governmental agency, have developed joint guidance
products and consulted on respective regulatory activities. In keeping
with the RCC's goal of regulatory cooperation, this final rule contains
several updates to the HCS that will align with Canada's Hazardous
Products Regulations (HPR), such as changes to exemptions for labeling
small containers and using prescribed concentration ranges when
claiming trade secrets (Document ID 0051).
B. Stakeholder Engagement
Since updating the HCS in 2012, OSHA has engaged stakeholders in
various ways in order to keep them apprised of changes to the GHS that
may have an impact on future updates to the HCS, as well as to gather
information about stakeholders' experience implementing the standard.
For example, in November 2016, OSHA convened a meeting to inform the
public that OSHA was beginning rulemaking efforts to maintain alignment
of the HCS with more recent revisions of the GHS (International/
Globally Harmonized System (GHS), Docket No. OSHA-2016-0005). Meeting
attendees discussed topics and issues that OSHA should consider during
the rulemaking. In addition, attendees provided suggestions as to the
types of publications (such as guidance products) that would be helpful
in complying with the standard and the topics they would like OSHA to
address in future compliance assistance materials.
OSHA has also engaged stakeholders through Interagency Group public
meetings held prior to each UNSCEGHS Session to discuss the issues and
proposals being presented at the UN. During this forum, stakeholders
have the opportunity to provide comments regarding the various
proposals under discussion. Stakeholders are also able to provide
comments on these proposals in writing via OSHA's docket for
International/Globally Harmonized System (GHS) (Docket No. OSHA-2016-
0005). The Interagency Group considers the comments and information
gathered at these public meetings and in the docket when developing the
U.S. position on issues before the UN.
Additionally, in December 2018, the RCC held a stakeholder forum in
Washington, DC. The purpose of the forum was to ``bring together senior
regulatory officials, industry, and other interested members of the
public from both sides of the border to discuss recent accomplishments
and new opportunities for regulatory cooperation'' (Document ID 0057).
OSHA led the session regarding chemicals management and workplace
chemicals.
C. OSHA Guidance Products, Letters of Interpretation, and Directives
Since OSHA's publication of the 2012 HCS update, the agency has
published guidance documents, issued letters of interpretation (LOIs),
and implemented an enforcement directive. These guidance documents are
available at: https://www.osha.gov/dsg/hazcom/guidance.html. OSHA will
continue to develop guidance documents to assist employers and
employees with their understanding of the HCS.
OSHA has issued several LOIs in response to questions from the
regulated community. These LOIs provide clarification on provisions in
the 2012 update to the HCS and how they apply in particular
circumstances. Some of the major issues covered in the LOIs include the
labeling of small containers, the labeling of chemicals released for
shipment, and the use of concentration ranges for trade secrets. OSHA's
LOIs on the HCS may be found at https://www.osha.gov/laws-regs/standardinterpretations/standardnumber/1910/1910.1200%20-%20Index/result. Several of the updates in this final rule clarify specific
elements of the enforcement guidance the agency has already provided in
LOIs and the directive. The agency anticipates publishing an updated
directive to provide guidance to OSHA compliance officers; however, the
2015 directive is still in force until rescinded or updated (Document
ID 0007).
OSHA requested comments in the NPRM on types of guidance documents
that the public may find useful to understand the updated HCS. The
American Society of Safety Professionals (ASSP) suggested that OSHA
``create training modules focused on the changes to the HCS once the
rule is finalized'' (Document ID 0284, p. 2). Hugo Hidalgo suggested
that the agency ``leverage technology to effectively communicate
hazards of chemicals to customers and end-users once the information
becomes available'' (Document ID 0297, p. 4). Other comments received
in response to OSHA's request for comments on guidance documents are
highlighted in Section XV., Issues and Options Considered. OSHA has
considered all requests for guidance and is evaluating the best
approaches to implement those requests and suggestions.
IV. Need and Support for the Revised Hazard Communication Standard
Hazardous chemical exposures in workplaces in the United States
present
a serious and ongoing danger to workers. Acute and chronic exposures to
hazardous chemicals in the workplace can have serious health
consequences. As described in the 2012 HCS, chemical exposures are
either directly responsible for or contribute to serious adverse health
effects including cancer; heart, lung, reproductive, and immunological
diseases; hearing loss; and eye and skin damage (77 FR 17584). In
addition to health effects, exposure to hazardous chemicals can result
in physical hazards, such as fires, explosions, and other dangerous
incidents (77 FR 17584). Recognition of the significant risk posed by
these workplace hazards was the impetus for OSHA to promulgate the
original hazard communication standard in order to promote responsible
chemical management practices (48 FR 53282-53283).
Hazard communication is a fundamental element of sound chemical
management practices. As stated in the GHS, ``[a]vailability of
information about chemicals, their hazards, and ways to protect people,
will provide the foundation for national programmes for the safe
management of chemicals'' (Document ID 0060, p. iii). An anonymous
comment on the NPRM stated that ``[a]rming employers with this
information, since the 1980s, has undoubtedly reduced the potential
for, and severity of, chemical and toxic substance injuries and
illnesses, to include a reduced number of fatalities. Globally
harmonizing the system for classification and labeling across a big
part of the world was also beneficial as it provided consistency, and
more simplicity, especially for foreign products utilized
domestically'' (Document ID 0300, p. 1). The commenter went on to state
that ``[p]roviding safety and health information to product users is
imperative. Ultimately, this information equals a form of protection''
(Document ID 0300, p. 1).
OSHA recognized the importance of a robust hazard communication
strategy as early as the 1980s, when the agency first promulgated the
HCS (48 FR 53282-53284). The agency also recognized the need for a
global strategy and was instrumental in the development of the GHS (48
FR 53287). From its inception, OSHA indicated that the HCS would be
updated periodically to keep pace with the advancement of scientific
principles underlying the hazard determination process as well as
improvements in communication systems (48 FR 53287). In hearing
testimony and post-hearing briefs, NIOSH provided documentation
supporting the continual updating of occupational safety and health
information, stating that the ``process should be a never-ending loop
of research and translation, allowing for ongoing integration of
effective approaches'' (Document ID 0456, Att. 15, p. 4).
The ``research and translation'' described by NIOSH is at the heart
of the GHS and HCS process--continually evaluating and updating to
improve worker protections and make hazard communication clearer and
more effective for both workers and employers. In addition to directly
enhancing worker protections through improved hazard communication,
updating the HCS to maintain alignment with the GHS also improves the
availability of important information to support larger efforts to
address workplace hazards. Commenters on the NPRM recognized this
principle. For example, Ameren stated that the modifications to the HCS
``takes a positive approach in our efforts of eliminating risk events''
(Document ID 0309, p. 2). ASSP commented, ``[w]e believe that aligning
the HCS to international regulations is beneficial overall to the OSH
profession and our members will assist in ensuring employers use these
enhanced requirements to better protect their workers'' (Document ID
0284, p. 1). The following sections provide more detailed information
on the need for the updates being finalized in this final rule.
A. Maintaining Alignment With the GHS and Ensuring That the Standard
Reflects the Current State of Science and Knowledge on Relevant Topics
Periodic updates to the HCS are needed to maintain pace with the
general advancement of science, technology, and our understanding of
the processes involved in effective communication. As stated in a
report published by the ILO in 2008, ``[c]ontinuous improvement of
occupational safety and health must be promoted. This is necessary to
ensure that national laws, regulations, and technical standards to
prevent occupational injuries, disease, and deaths are adapted
periodically to social, technical, and scientific progress and other
changes in the world of work'' (ILO, 2008, Document ID 0181).\1\ While
the tools and protective measures in place to reduce or prevent
chemical-related occupational injuries and illnesses are effective,
such tools and systems become less effective as time goes by and new
technologies and workplace hazards emerge. Therefore, there is a need
for continual improvement in the systems and processes designed to
identify, communicate about, and reduce workplace exposures to chemical
hazards.
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\1\ The ILO and the World Health Organization (WHO) have also
adopted an evergreen approach to workplace hazard communication
(i.e., an approach that ensures systems for hazard communication
remain relevant and up-to-date). The ILO and WHO produce
international chemical safety cards (ICSC) and maintain a database
of approximately 1,700 data sheets designed to provide safety and
health information on hazardous chemicals in a format consistent
with the GHS. While not exactly like SDSs, ICSCs use phrases similar
to GHS precautionary statements to convey safety and health
information about workplace chemicals in a consistent,
internationally accessible manner. ICSCs also display classification
information (hazard pictograms, signal words, and hazard statements)
in line with GHS classification criteria--this information is added
during updates. With participation by experts from government
agencies around the world, including the U.S. (Centers for Disease
Control and Prevention (CDC)/NIOSH), Canada (Quebec-CNESST), Japan
(National Institute of Health Sciences), and several European
countries, ICSCs are prepared and periodically updated to account
for the most recent scientific developments. Due to the robust
process of preparation and peer review, the ICSCs are considered
authoritative in nature and a significant asset for workers and
health professionals across the globe, including in the United
States (ILO, 2019, Document ID 0069).
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The changes finalized in this update to the HCS will result in
better alignment between the standard and the continually evolving GHS.
The first edition of the GHS, adopted in December 2002 and published in
2003, implemented the 16-section format for SDSs \2\ that is now
standard across much of the globe. As information has improved, the GHS
has updated the form and content of SDSs to improve readability,
minimize redundancies, and ensure hazards are communicated
appropriately (Document ID 0060; Document ID 0237).
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\2\ SDSs, as adopted by the HCS, are intended to provide
comprehensive information about a substance or mixture for use in
the workplace, including identification of the substance or mixture;
hazard identification; composition/ingredient information; first aid
measures; fire-fighting measures; accidental release measures;
handling and storage; exposure controls/personal protective
measures; physical and chemical properties; stability and
reactivity; toxicological information; ecological information;
disposal considerations; transport information; regulatory
information; and other information that may be relevant to the
workplace (e.g., date the SDS was prepared, key literature
references, and sources of data used to prepare the SDS).
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Information OSHA has collected since publication of the 2012 update
to the HCS indicates that aligning the HCS with the GHS has had a
positive impact on workplace hazard communication. Data from published
studies indicate that the hazard communication
approach taken in the 2012 HCS has been effective, when implemented
appropriately, in enabling workers to understand, avoid, and mitigate
exposures to hazardous chemicals in the workplace (Bechtold, 2014,
Document ID 0061; Elliott, 2016, Document ID 0119). Industry
representatives have indicated that workers responded positively to
training on pictograms and hazard statements because it explained
distinctions between acute toxicity and chronic health effects
(Bechtold, 2014, Document ID 0061). Consistent labeling requirements
have also enabled employers to identify the most hazardous materials in
the workplace, understand more about the health effects of these
chemicals, and address which hazardous chemicals they may want to
replace with safer alternatives (Bechtold, 2014, Document ID 0061).
Labels and SDSs are often the first indication to a worker that
they are handling a hazardous chemical, so it is imperative that labels
and SDSs be as accurate and complete as possible. While the HCS does
not require testing of chemicals, it does require that labels and SDSs
have accurate information based on all available evidence and that
manufacturers, importers, distributors, and employers provide the
complete information on the hazards available to them. Without a
complete picture of the hazards associated with a particular chemical,
workers cannot know how to adequately protect themselves or safely
handle these chemicals. North America's Building Trades Unions (NABTU)
commented that ``[It] is really important to have . . . the labels on
the products that are being used because that's the first source of
information. The SDS is the backup source . . . . [Labels and SDSs are]
where they're going to get information on the hazards of what they're
using and the precautions that need to be taken, including . . . any
engineering controls or any personal protective equipment'' (Document
ID 0464, p. 2).
Several studies published since the 2012 HCS adopted the 16-section
SDS format indicate that the new format has improved comprehension in
the workplace (Elliott, 2016, Document ID 0119; Boelhouver, 2013,
Document ID 0107). However, other recent studies have shown that the
system can still be improved upon. Multiple studies in various
industries have demonstrated that while comprehension has improved,
many SDSs lack information vital to worker protection. Problems include
insufficient information on the identification of substances/mixtures;
inadequate hazard identification and classification information (e.g.,
missing information on carcinogens and sensitizers, incorrect chemical
classifications); lack of precautionary statements on safe handling;
missing information on exposure controls/personal protective equipment;
and missing toxicological information (Jang, 2019, Document ID 0110;
Allen, 2017, Document ID 0117; DiMare, 2017, Document ID 0118; Tsai,
2016, Document ID 0016; Friis, 2015, Document ID 0120; Saito, 2015,
Document ID 0191; Suleiman, 2014, Document ID 0192; Lee, 2012, Document
ID 0070). A 2014 study concluded that the contents of the SDSs
evaluated were generic and incomplete, lacking important safety
measures and health information (Suleiman, 2014, Document ID 0192). A
study on mixtures found that information on individual ingredients
within mixtures was sometimes completely missing and that information
on hazard characterization and classification was ambiguous and almost
entirely incorrect (LeBouf, 2019, Document ID 0183). Furthermore, a
2012 study conducted by NIOSH found that SDSs for certain classes of
chemicals lacked sufficient information to communicate the appropriate
hazards and remedies related to engineered nanomaterials (Eastlake,
2012, Document ID 0063). A follow-up NIOSH study found some improvement
in SDS preparation since implementation of the 2012 HCS; however, the
study also found that there are still serious deficiencies in providing
adequate information on the inherent health and safety hazards of
engineered nanomaterials, including handling and storage (Hodson, 2019,
Document ID 0167).
Inadequate information on the chemical hazards and risk management
practices required on SDSs can lead to overexposure to chemical hazards
and puts workers at risk. An anonymous commenter stated that
``[i]naccurate information makes it difficult for downstream users who
have to rely on inaccurate or incomplete information . . . '' (Document
ID 0308, p. 1). The studies described above demonstrate the need for
ongoing review and refinement to make certain the standard is
addressing comprehensibility issues and staying relevant with current
occupational safety and health tools, science, and technology. This
final rule's updates to Appendix D, which are based in part on recent
revisions to the GHS, seek, among other things, to remedy the issues
that have been identified by clarifying the information needed in the
SDS. For example, a change in Section 9 (physical characteristics to
include particle characteristics) will identify exposure issues that
were not addressed by the previous format. This should, among other
things, improve the hazard information required for nanomaterials.
Furthermore, the GHS has been updated to reflect the development of
non-animal test methods for use in hazard determination and
classification. The development of these test methods led to updates in
Chapter 3.2 (which correspond to updates in this final rule to Appendix
A.2 of the HCS) on skin corrosion/irritation that incorporated new in
vitro test methods, and computational or in silico techniques, to
classify chemicals for this category of hazard (Document ID 0242). And
techniques and processes developed in the behavioral sciences have led
to the development of more effective communication practices for
occupational safety and health purposes (NIOSH, 2019, Document ID
0126).\3\ Studies evaluating the effectiveness of precautionary
statements and pictograms used in the GHS have led to their evolution
and continued revisions (Fagotto, 2003, Document ID 0125; ISHN, 2019,
Document ID 0068; Ta, 2010, Document ID 0115; Ta, 2011, Document ID
0194; Chan, 2017, Document ID 0017).
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\3\ Holistic programs such as NIOSH's Total Worker Health
program, where behavioral science is integrated into more
traditional risk-management practices, require robust hazard
communication practices (Tamers, 2019, Document ID 0076).
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Regularly updating the HCS to align with international practices
also eases compliance for global corporations because it provides
greater international consistency (Bechtold, 2014, Document ID 0061).
Industry groups such as the American Petroleum Institute (API) have
indicated their support for regular HCS updates as long as there is
sufficient input from stakeholders (Document ID 0167). During the 2012
rulemaking, numerous safety organizations (including NIOSH, the
American Chemical Society (ACS), the American Industrial Hygiene
Association (AIHA), the American Society of Safety Engineers (ASSE),
the Center for Protection of Workers' Rights (CPWR), and the Society
for Chemical Hazard Communication (SCHC)) publicly supported OSHA's
continued updates to the HCS (see 77 FR 17585, 17603). The Society of
Toxicology (SOT) also expressed support for updating the HCS to align
with the GHS as this ``creates consistent communication about the
hazards of chemicals across the globe'' (see 77 FR 17585).
B. Cooperating With International Trading Partners and Other Federal
Agencies
OSHA expects that the updates to the HCS will facilitate
cooperation with international trading partners and other federal
agencies. The U.S. and Canada participate in the RCC, which has a goal
to ``enhance regulatory cooperation and economic competitiveness that
maintain high standards when it comes to health, safety, and the
environment'' (Document ID 0127). OSHA continues to work with Health
Canada through the RCC to develop guidance documents pertaining to
hazard communication issues the two countries share and to work
cooperatively through the UNSCEGHS subcommittee. In addition, OSHA and
Health Canada share regular updates on regulatory activity. As
explained in the Section XIV., Summary and Explanation of the Final
Rule, several updates in this final rule will align U.S. and Canadian
hazard communication practices, thereby facilitating cooperation
between the two countries, easing compliance for employers who
participate in both markets, and strengthening worker protections by
providing harmonized hazard communication standards across trade
borders.
In addition, OSHA is updating the requirements for bulk shipment
under paragraph (f)(5) to provide additional clarity for shipments that
are also regulated by the DOT. For bulk shipments, the finalized new
paragraph should increase flexibility by allowing labels to be placed
on the immediate container or transmitted with shipping papers, bills
of lading, or by other technological or electronic means so that they
are immediately available to workers in printed form on the receiving
end of the shipment. This allows for the full label information to be
available to the downstream user upon receipt while recognizing the
unique DOT placarding issues for bulk shipments. And in another effort
to facilitate inter-agency cooperation, OSHA is finalizing new language
for paragraph (f)(5) providing that where a pictogram required by the
DOT appears on the label for a shipped container, the HCS pictogram for
the same hazard may also be provided, but is not required to
acknowledge that the DOT regulations allow for the GHS pictogram to be
on the shipped container (49 CFR 172.401(c)(5)).
C. Responding to Stakeholder Experiences Implementing the 2012 HCS
Finally, some of the changes in this final rule, including those
related to labeling of small containers and relabeling requirements for
chemicals that have been released for shipment, were developed in
response to feedback and comments received from stakeholders since the
promulgation of the 2012 updates to the HCS (Collatz, 2015, Document ID
0174; Ghosh, 2015, Document ID 0180). With respect to the labeling of
small containers, issues raised by stakeholders included concerns about
insufficient space on the label to highlight the most relevant safety
information, problems with the readability of information on small
labels, and challenges associated with using fold-out labels for
certain small containers that need special handling (Watters, 2013,
Document ID 0200; Collaltz, 2015, Document ID 0174; Blankfield, 2017,
Document ID 0170). This final rule includes revisions designed to
address these issues with small container labeling as well as revisions
addressing other issues raised by commenters. Furthermore, OSHA
believes that adopting a uniform approach to labeling small containers
will enhance worker protections by ensuring that critical information
on the hazards posed by the chemicals is included on the label
regardless of the size of the container. For a full discussion of this
change, see the Summary and Explanation for (f)(12).
Similarly, the finalized revisions to paragraph (f)(11), which
address the relabeling of chemicals that have been released for
shipment, are designed to address stakeholder concerns about the
difficulty some manufacturers have in complying with the HCS's
requirements to update labels when new information becomes available,
especially in the case of chemicals that travel through long
distribution cycles (Kenyon, 2017, Document ID 0182). This final rule
revises paragraph (f)(11) to address these concerns while maintaining
worker protections.
V. Pertinent Legal Authority
A. Background
The purpose of the Occupational Safety and Health Act of 1970 (the
OSH Act or Act) (29 U.S.C. 651 et seq.) is ``to assure so far as
possible every working man and woman in the Nation safe and healthful
working conditions and to preserve our human resources.'' 29 U.S.C.
651(b). To achieve this goal, Congress authorized the Secretary of
Labor to promulgate occupational safety and health standards after
notice and comment. 29 U.S.C. 655(b). An occupational safety and health
standard is a standard ``which requires conditions, or the adoption or
use of one or more practices, means, methods, operations, or processes,
reasonably necessary or appropriate to provide safe or healthful
employment and places of employment.'' 29 U.S.C. 652(8).
The OSH Act also authorizes the Secretary to ``modify'' or
``revoke'' any occupational safety or health standard, 29 U.S.C.
655(b), and under the Administrative Procedure Act, regulatory agencies
generally may revise their rules if the changes are supported by a
reasoned analysis. See Encino Motorcars, LLC v. Navarro, U.S., 136 S.
Ct. 2117, 2125-26 (2016); Motor Vehicle Mfrs. Ass'n v. State Farm Mut.
Auto. Ins. Co., 463 U.S. 29, 42 (1983). In passing the OSH Act,
Congress recognized that OSHA should revise and replace its standards
as ``new knowledge and techniques are developed.'' S. Rep. 91-1282 at 6
(1970). The Supreme Court has observed that administrative agencies
``do not establish rules of conduct to last forever, and . . . must be
given ample latitude to adapt their rules and policies to the demands
of changing circumstances.'' Motor Vehicle Mfrs. Ass'n, 463 U.S. at 42
(internal quotation marks and citations omitted).
Before the Secretary can promulgate any permanent health or safety
standard, they must make a threshold finding that significant risk is
present and that such risk can be eliminated or lessened by a change in
practices. Indus. Union Dep't v. Am. Petroleum Inst., 448 U.S. 607, 642
(1980) (plurality opinion) (``Benzene''). As explained more fully in
Section V.D., Significant Risk, OSHA need not make additional findings
on risk for this final rule because OSHA previously determined that the
HCS addresses a significant risk. 77 FR 17603-17604.
In promulgating a standard under, and making the determinations
required by, the OSH Act, OSHA's determinations will be deemed
conclusive if they are ``supported by substantial evidence in the
record considered as a whole.'' 29 U.S.C. 655(f). OSHA must use the
``best available evidence,'' which includes ``the latest available
scientific data in the field''; ``research, demonstrations,
experiments, and such other information as may be appropriate''; and
``experience gained under this and other health and safety laws.'' 29
U.S.C. 655(b)(5).
B. Authority--Section 6(b)(5)
The HCS is a health standard promulgated under the authority of
section 6(b)(5) of the OSH Act. See Associated Builders & Contractors,
Inc. v. Brock, 862 F.2d 63, 67-68 (3d Cir.
1988); United Steelworkers of Am. v. Auchter, 763 F.2d 728, 735 (3d
Cir. 1985); 77 FR 17601. Section 6(b)(5) of the OSH Act provides that
``in promulgating health standards dealing with toxic materials or
harmful physical agents,'' the Secretary must ``set the standard which
most adequately assures, to the extent feasible, on the basis of the
best available evidence, that no employee will suffer material
impairment of health or functional capacity even if such employee has
regular exposure to the hazard dealt with by such standard for the
period of his working life.'' 29 U.S.C. 655(b)(5). Thus, once OSHA
determines that a significant risk due to a health hazard is present
and that such risk can be reduced or eliminated by an OSHA standard,
section 6(b)(5) requires OSHA to issue the standard, based on the best
available evidence, that ``most adequately assures'' employee
protection, subject only to feasibility considerations. As the Supreme
Court has explained, in passing section 6(b)(5), Congress ``place[d] .
. . worker health above all other considerations save those making
attainment of this `benefit' unachievable.'' Am. Textile Mfrs. Inst.,
Inc. v. Donovan, 452 U.S. 490, 509 (1981) (``Cotton Dust'').
C. Other Authority
The HCS is also promulgated under the authority of section 6(b)(7)
of the OSH Act. See United Steelworkers, 763 F.2d at 730; 77 FR 17601.
Section 6(b)(7) of the OSH Act provides in part: ``Any standard
promulgated under this subsection shall prescribe the use of labels or
other appropriate forms of warning as are necessary to insure that
employees are apprised of all hazards to which they are exposed,
relevant symptoms and appropriate emergency treatment, and proper
conditions and precautions of safe use or exposure.'' 29 U.S.C.
655(b)(7). Section 6(b)(7)'s labeling and employee warning requirements
provide basic protections for employees, particularly in the absence of
specific permissible exposure limits, by providing employers and
employees with information necessary to design work processes that
protect employees against exposure to hazardous chemicals in the first
instance.
The last sentence of section 6(b)(7) provides that the Secretary,
in consultation with the Secretary of Health and Human Services, may
issue a rule pursuant to 5 U.S.C. 553 to ``make appropriate
modifications in the foregoing requirements relating to the use of
labels or other forms of warning . . . as may be warranted by
experience, information, or medical or technological developments
acquired subsequent to the promulgation of the relevant standard.'' 29
U.S.C. 655(b)(7). OSHA used the authority granted by this paragraph to
promulgate the 2012 revisions to the HCS, 77 FR 17602, and this
provision provides additional authority for this final rule.
This final rule, which is an update to the existing HCS, fits well
within the authority granted by the last sentence of section 6(b)(7).
The changes in the final rule constitute a ``modification'' of the HCS
regarding ``the use of labels or other forms of warning.'' As explained
more fully elsewhere in this preamble, OSHA has determined the updates
are ``appropriate'' based on ``experience, information, or medical or
technological developments acquired subsequent to the promulgation of
the relevant standard.'' The updates found in GHS Rev. 7 are a
``technological development'' that has occurred since the 2012
revisions to the HCS and are also ``warranted by experience [and]
information.'' The GHS was negotiated and drafted through the
involvement of labor, industry, and governmental agencies, and thus
represents the collective experience and information on hazard
communication gathered by the participants in these sectors over the
last several decades. See 71 FR 53617, 53618-53619; \4\ see also
Section III.: Events Leading to the Revised Hazard Communication
Standard in this preamble.
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\4\ The last sentence of section 6(b)(7) requires consultation
with the Secretary of Health and Human Services. OSHA briefed NIOSH
on the proposal for this rule during a collaboration meeting held in
December 2018, which was attended by the Director of NIOSH, and
NIOSH expressed its support. NIOSH continued to express support in
its comments on the proposed rule (Document ID 0281) and also
supported OSHA's update of the HCS in 2012, see 77 FR 17603.
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Authority for the HCS is also found in Section 8, paragraphs (c)
and (g), of the OSH Act. Section 8(c)(1) of the OSH Act empowers the
Secretary to require employers to make, keep, and preserve records
regarding activities related to the OSH Act and to make such records
available to the Secretary. 29 U.S.C. 657(c)(1). Section 8(g)(2) of the
OSH Act empowers the Secretary to ``prescribe such rules and
regulations as he may deem necessary to carry out [his]
responsibilities'' under the Act. 29 U.S.C. 657(g)(2).
D. Significant Risk
As required by section 6(b)(5) of the OSH Act, OSHA originally
determined that the HCS would substantially reduce a significant risk
of material harm when promulgating the standard in 1983. Many OSHA
health standards protect employees by imposing requirements when
employees are exposed to a concentration of a hazardous substance that
OSHA has found creates a significant risk of material health
impairment. Thus, in making the significant risk determination in those
cases, OSHA measures and assesses the hazards of employee exposures to
determine the level at which a significant risk arises.
OSHA took a different approach to its significant risk
determination when first promulgating the HCS. Rather than attempting
to assess the risk associated with exposures to each hazardous chemical
in each industry to determine if that chemical posed a significant risk
in that industry, OSHA took a more general approach. It relied on NIOSH
data showing that about 25 million or about 25 percent of American
employees were potentially exposed to one or more of 8,000 NIOSH-
identified chemical hazards and that for the years 1977 and 1978 more
than 174,000 illnesses were likely caused by exposure to hazardous
chemicals. 48 FR 53282. OSHA then noted the consensus evident in the
record among labor, industry, health professionals, and government that
an ``effective [F]ederal standard requiring employers to identify
workplace hazards, communicate hazard information to employees, and
train employees in recognizing and avoiding those hazards'' was
necessary to protect employee health. 48 FR 53283. Based on that
evidence, OSHA determined that the HCS addressed a significant risk
because ``inadequate communication about serious chemical hazards
endangers workers,'' and that the practices required by the standard
were ``necessary or appropriate to the elimination or mitigation of
these hazards.'' 48 FR 53321. The U.S. Court of Appeals for the Third
Circuit agreed that ``inadequate communication is itself a hazard,
which the standard can eliminate or mitigate.'' United Steelworkers,
763 F.2d at 735. That court has upheld OSHA's determination of
significant risk as sufficient to justify the HCS. See Associated
Builders & Contractors, 862 F.2d at 67-68 (discussing the history of
its review of the issue).
OSHA reaffirmed its finding of significant risk in adopting
revisions to the HCS in 1994. See 59 FR 6126-6133. When revising the
HCS to adopt the GHS model in 2012, OSHA found that there remained a
``significant risk of inadequate communication'' of chemical hazards in
the workplace and that adopting the standardized requirements of the
GHS would
substantially reduce that risk by improving chemical hazard
communications. 77 FR 17603-17604.
For the changes in this final rule, OSHA has not made a new finding
of significant risk but is making changes that are reasonably related
to the purpose of the HCS as a whole. When, as here, OSHA has
previously determined that its standard substantially reduces a
significant risk, it is unnecessary for the agency to make additional
findings on risk for every provision of that standard. See, e.g., Pub.
Citizen Health Research Grp. v. Tyson, 796 F.2d 1479, 1502 n.16 (D.C.
Cir. 1986) (rejecting the argument that OSHA must ``find that each and
every aspect of its standard eliminates a significant risk''). Rather,
once OSHA makes a general significant risk finding in support of a
standard, the next question is whether a particular requirement is
reasonably related to the purpose of the standard as a whole. See
Asbestos Info. Ass'n/N. Am. v. Reich, 117 F.3d 891, 894 (5th Cir.
1997); Forging Indus. Ass'n v. Sec'y of Labor, 773 F.2d 1436, 1447 (4th
Cir. 1985); United Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647
F.2d 1189, 1237-38 (D.C. Cir. 1980) (``Lead I'').
Furthermore, the Supreme Court has recognized that protective
measures like those called for by the HCS may be imposed in workplaces
where chemical exposure levels are below that for which OSHA has found
a significant risk. In Benzene, the Court recognized that the
``backstop'' provisions of section 6(b)(7) allow OSHA to impose
information requirements even before the employee is exposed to the
significant risk. See Benzene, 448 U.S. at 657-58 & n.66. Rather than
requiring a finding of significant risk, the last sentence of section
6(b)(7) provides other assurances that OSHA is exercising its authority
appropriately by requiring the involvement of the Secretary of Health
and Human Services, and by limiting the authority only to modifications
that are based on ``experience, information, or medical or
technological developments'' acquired since the promulgation of the
standard in the limited areas of hazard communication, monitoring, and
medical examinations. Therefore, OSHA need not make any new significant
risk findings; rather, the final rule is supported by the significant
risk findings that OSHA made when it adopted the current HCS.\5\ See 77
FR 17602.
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\5\ Section 6(b)(7) of the OSH Act also exempts modifications to
hazard communication, monitoring, and medical examination
requirements from the standard-setting requirements of section 6(b),
and so evidences Congress' intent to provide OSHA with an expedited
procedure to update these requirements. The last sentence of section
6(b)(7) merely allows these requirements to be updated to reflect
the latest knowledge available. The authorization to use
Administrative Procedure Act notice and comment procedures rather
than the more elaborate framework established by section 6(b)
demonstrates congressional intent to treat such modifications
differently from rulemakings to adopt standards. Congress envisaged
a simple, expedited process that is inconsistent with the idea that
OSHA must undertake additional significant risk analyses before
exercising this authority, See 77 FR 17602.
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E. Feasibility
Because section 6(b)(5) of the OSH Act explicitly requires OSHA to
set health standards that eliminate risk ``to the extent feasible,''
OSHA uses feasibility analyses to make standards-setting decisions
dealing with toxic materials or harmful physical agents. 29 U.S.C.
655(b)(5); Cotton Dust, 452 U.S. at 509. Feasibility in this context
means ``capable of being done, executed, or effected.'' Id. at 508-09.
Feasibility has two aspects, economic and technological. Lead I, 647
F.2d at 1264. A standard is technologically feasible if the protective
measures it requires already exist, can be brought into existence with
available technology, or can be created with technology that can
reasonably be expected to be developed. See id. at 1272. A standard is
economically feasible if industry can absorb or pass on the cost of
compliance without threatening its long-term profitability or
competitive structure. See Cotton Dust, 452 U.S. at 530 n.55; Lead I,
647 F.2d at 1265. OSHA's determinations regarding feasibility are
discussed more fully in Section VI.E., Technological Feasibility, and
Section VI.G., Economic Feasibility and Impacts, in this preamble.
VI. Final Economic Analysis and Regulatory Flexibility Analysis
A. Introduction and Summary
Under Executive Order 12866 (E.O.) 12866, OIRA determines whether a
regulatory action is significant and, therefore, subject to the
requirements of E.O. 12866 and OMB review. Section 3(f) of E.O. 12866,
as amended by E.O. 14094, defines a ``significant regulatory action''
as an action that is likely to result in a rule that: (1) has an annual
effect on the economy of $200 million or more, or adversely affects in
a material way a sector of the economy, productivity, competition,
jobs, the environment, public health or safety, or State, local or
tribal governments or communities (also referred to as significant
under Section 3(f)(1)); (2) creates serious inconsistency or otherwise
interferes with an action taken or planned by another agency; (3)
materially alters the budgetary impacts of entitlements, grants, user
fees, or loan programs, or the rights and obligations of recipients
thereof; or (4) raises novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in E.O. 12866. Upon review, OMB has determined that this final rule is
a significant regulatory action under E.O. 12866.\6\ Pursuant to the
Congressional Review Act (5 U.S.C. 801 et seq.), OIRA designated that
this rule is not a ``major rule,'' as defined by 5 U.S.C. 804(2).
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\6\ https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=1218-AC93.
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OIRA has made a determination that this action is not a significant
regulatory action under section 3(f)(1) of E.O. 12866, as amended by
E.O. 14094, because it is not likely to have an annual effect on the
economy of $200 million or more. Nor is this final standard a major
rule under the Congressional Review Act because this rule will not
result in (1) an annual effect on the economy of $100 million or more;
(2) a major increase in costs or prices for consumers, individual
industries, federal, state, or local government agencies, or geographic
regions; nor (3) significant adverse effects on competition,
employment, investment, productivity, or innovation, or on the ability
of United States-based enterprises to compete with foreign-based
enterprises in domestic and export markets. 5 U.S.C. 804(2). Details on
the estimated cost-savings of this rule can be found in the economic
analysis below.
E.O. 13563 directs agencies to adopt a regulation only upon a
reasoned determination that its benefits justify its costs; tailor the
regulation to impose the least burden on society, consistent with
obtaining the regulatory objectives; and in choosing among alternative
regulatory approaches, select those approaches that maximize net
benefits. E.O. 13563 recognizes that some benefits are difficult to
quantify and provides that, where appropriate and permitted by law,
agencies may consider and discuss qualitatively values that are
difficult or impossible to quantify, including equity, human dignity,
fairness, and distributive impacts.
Because section 6(b)(5) of the OSH Act explicitly imposes the ``to
the extent feasible'' limitation on the setting of health standards,
OSHA is not permitted to use cost-benefit analysis to make its
standards-setting decisions (see 29 U.S.C. 655(b)(5); Cotton Dust, 452
U.S. at 509). In addition to determining economic feasibility, OSHA
estimates the costs and benefits of its proposed and final rules to
ensure compliance with other requirements such as those in E.O. 12866
and E.O. 13563.
In this FEA, OSHA estimates that the proposed amendments to the HCS
would result in annualized net cost savings of $29.8 million at a seven
percent discount rate. Annualized at a three percent discount rate,
OSHA estimates that the proposed amendments to the rule would lead to
net cost savings of $30.7 million per year. OSHA expects that the
revisions to the HCS will also result in modest improvements in worker
health and safety above those already being achieved under the current
HCS, but the agency is unable to quantify the magnitude of these
benefits.
The remainder of this FEA includes the following sections:
B. Need for Regulation
C. Profile of Affected Industries, Establishments, and Employees
D. Health and Safety Benefits and Unquantified Positive Economic
Effects
E. Technological Feasibility
F. Compliance Costs and Cost Savings
G. Economic Feasibility and Impacts
H. Final Regulatory Flexibility Screening Analysis and FRFA
Certification
B. Need for Regulation
Employees in work environments covered by OSHA's HCS are exposed to
a variety of significant hazards associated with chemicals used in the
workplace that can and do cause serious injury, illness, and death. The
HCS serves to ensure that both employers and employees are provided the
information they need about these chemical hazards. The HCS contains a
set of requirements for chemical products, including mandatory hazard
classification, labeling requirements, provisions for communication of
detailed information (in SDSs), and label updating requirements. These
requirements are based on Rev. 3 of the GHS, which was adopted by the
UNSCEGHS in December 2008.
OSHA, in the 2021 Preliminary Economic Analysis (PEA), determined
that the revisions to the HCS would make employers' hazard
communication programs more worker-protective, efficient, and effective
through standardizing practices nationally and internationally (86 FR
9590). In addition, OSHA found that aligning with the GHS Rev. 7 would
continue to facilitate international trade, as a number of U.S. trading
partners are also preparing to align with Rev. 7 (86 FR 9590-91).
The revisions to the HCS include the following notable changes:
Maintaining alignment with the GHS:
[cir] Adding classification categories for aerosols, desensitized
explosives, and flammable gases; and
[cir] Updating select hazard and precautionary statements for
clearer and more precise hazard information.
Addressing issues identified in implementing the 2012 HCS:
[cir] Updating labeling requirements for small containers;
[cir] Updating labeling requirements for packaged containers that
have been released for shipment or that constitute bulk shipping; and
[cir] Allowing the withholding of concentration ranges of
substances for reasons related to trade secrets.
As discussed in Section VI.F., Compliance Costs and Cost Savings,
of this FEA, the estimated costs and cost savings resulting from the
final revisions to the HCS consist of five main categories: (1) the
cost of reclassifying affected chemicals and revising the corresponding
SDSs and labels to achieve consistency with the reclassification (per
changes to Appendix B), and the cost of revising SDSs and labels to
conform with new precautionary statements and other new mandatory
language in the appendices to the HCS (per changes to Appendices C and
D); (2) the cost of management familiarization and other management-
related costs (associated with all of the revisions to the standard);
(3) the cost of training employees as necessitated by the changes to
the HCS (see paragraph (h)(1) of the 2012 HCS); (4) the cost savings
resulting from the new released-for-shipment provision (revisions to
paragraph (f)(11)); and (5) the cost savings from limiting labeling
requirements for certain very small containers (proposed paragraph
(f)(12)). The first three categories are considered to be one-time
costs and the last two categories are cost savings that would accrue to
employers annually.
The changes to the HCS will maintain the uniformity of hazard
information with the GHS and will, accordingly, serve to improve the
efficiency and effectiveness of the existing hazard communication
system in the U.S., ensure that updated and advanced HCS methods are
recognized, and reduce unnecessary barriers to trade. In short, the GHS
is a ``uniformity standard'' for the presentation of hazard information
(Document ID 0050). And much like other uniformity standards, such as
driving on the right side of the road (in the U.S.), screw threads for
fire hose connectors, ``handshake'' protocols for communication between
computers, and, for that matter, language, the GHS provides significant
efficiencies and economies.\7\
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\7\ A specification standard, such as an engineering standard,
would spell out, in detail, the equipment or technology that must be
used to achieve compliance. The usual rationale for a specification
standard is that compliance would be difficult to verify under a
performance standard; hence, a specification standard would better
protect employees against the risk in question. A specification
standard would generally not provide the efficiencies or economies
(such as easier, less expensive training on uniform pictograms and a
uniform SDS format made possible by the GHS) to the regulated
community that a uniformity standard would. On the contrary, a
specification standard could impose additional costs on some firms
that may be able to effectively protect workers using a cheaper
alternative approach if such flexibility were permitted. It is also
worth noting that, for uniformity standards with technological
implications, the benefits of reduced information costs, economies
of uniformity, and facilitation of exchange may need to be weighed
against possible losses of flexibility, experimentation, and
innovation. However, because the GHS is limited to the presentation
of hazard information and does not involve other than incidental
technological or strategic considerations, the possible costs of
uniformity here would be minuscule.
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Since publication of the update to the HCS in 2012, there continues
to be movement by U.S. trading partners toward maintaining
standardization, consistent with the revisions in the GHS. However,
OSHA does not believe that full and comprehensive standardization in
accordance with the GHS, or the goal of harmonizing the U.S. system
with the international one, can be achieved voluntarily in the absence
of regulation.
First, the market alone will not ensure timely alignment with the
GHS as it undergoes revision periodically. Additionally, in some cases
(e.g., aerosols, desensitized explosives), Rev. 7 contains different
hazard classes or classification criteria than the 2012 HCS, and it
would be impermissible for a manufacturer to comply with Rev. 7 rather
than the criteria in the existing HCS. Second, while the costs of
creating SDSs and labels are borne directly by the chemical producers,
maintaining alignment with the GHS benefits the users of hazardous
chemicals. These users include employers who are direct customers of
chemical manufacturers, employees who use or are exposed to workplace
chemicals, and emergency responders who typically have no market
relationship with the chemical producers. Even if market forces could
ensure the socially optimal approach to SDSs between chemical
manufacturers and their customers, there are limited market forces at
work between the chemical manufacturer and two key sets of users: the
employees and the emergency response community.
Therefore, the benefits achieved by maintaining alignment with the GHS
are unlikely to be obtained in the private market without regulation.
OSHA recognizes that there will be some market pressure to align
with Rev. 7 as its adoption expands internationally.\8\ Some firms in
the U.S. may think that they have no need to follow the GHS because
they do not ship their products internationally. These firms may not
realize the extent to which they are involved in international trade.
There are probably few companies that have products that are never
involved in international trade or that never import chemical products
requiring hazard information.\9\ Many chemical producers ship their
products to distributors and are unaware of where their products are
ultimately used. These distributors might well put pressure on their
suppliers to maintain compliance with the GHS. Further, small companies
sell chemicals to larger companies. The larger companies may use those
chemicals to make other products that are exported. These larger
companies might also pressure their small-firm suppliers to align with
the GHS. Nevertheless, relying solely on market pressures would surely
involve a long transition period, with attendant losses in worker
protection and production efficiencies, and it is unlikely that the
market alone will ensure full alignment with the GHS for reasons
described above.
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\8\ See UN, 2018, pp. 12-13 (Document ID 0040).
\9\ According to the U.S. International Trade Commission, U.S.
imports of chemicals and related products increased 23 percent from
2015 ($260.4 billion) to 2019 ($320.1 billion); and U.S. exports of
chemicals and related products increased 7 percent from 2015 ($227.7
billion) to 2019 ($243.7 billion) (Document ID 0234). And the
American Chemistry Council reported that in 2019, total U.S.
chemical exports accounted for 10 percent of all U.S. goods exports
and 10 percent of all global chemical exports (Document ID 0235).
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The changes to the HCS will involve costs and cost savings mainly
for manufacturers, importers, and distributors. Manufacturers and
importers of chemicals will also achieve benefits, in part because they
themselves benefit as both producers and users, and in part because of
foreign trade benefits. Some manufacturers may not obtain trade
benefits unless they engage in chemical export. International
harmonization of hazard communication requirements may also make it
easier for small companies to engage in international trade if they so
desire (see additional discussion below in VI.D., Health and Safety
Benefits and Unquantified Positive Economic Effects).
Of more significance to the concerns of the OSH Act, the changes
will also provide health benefits from improved hazard classification
and communication; although unquantified in this final rule, these
benefits include reductions in worker illnesses, injuries, and
fatalities (see additional discussion below in VI.D., Health and Safety
Benefits and Unquantified Positive Economic Effects).
Because many of the health and safety benefits and cost savings
described in this analysis require uniformity and are dispersed among a
network of producers and users, only some of whom have direct market
relationships with each other, OSHA believes maintaining a single,
uniform standard will best achieve the full benefits available from a
hazard communications system.
C. Profile of Affected Industries, Establishments, and Employees
In this section, OSHA presents a final profile of industries
affected by this revision to the HCS. The profile data in this section
are based upon the 2012 HCS FEA and the PEA supporting the 2021 HCS
NPRM, updated in this FEA with the most recent data available.
As a first step, OSHA identifies the North American Industry
Classification System (NAICS) industries affected by the changes to the
HCS.\10\ Next, OSHA provides statistical information on the affected
industries, including the number of affected entities and
establishments; the number of workers whose exposure to the chemicals
subject to the HCS could result in injury, illness, or death
(``affected relevant employees''); and the average revenues and profits
for affected entities and establishments by six-digit NAICS
industry.\11\ This information is provided for each affected industry
as a whole, as well as for small entities, as defined by the Small
Business Administration (SBA) \12\ and for ``very small'' entities,
defined by OSHA as those with fewer than 20 employees, in each affected
industry (U.S. Census Bureau, 2020a, Document ID 0231; U.S. Census
Bureau, 2020b, Document ID 0232).
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\10\ For this FEA, OSHA used 2017 NAICS industry categorization
and nomenclature. Although the 2017 NAICS categorization was updated
in 2022, OSHA notes that all profile data presented in this FEA were
published in 2022 or earlier years but are pre-2022 in content, and
therefore were assigned 2017 NAICS IDs.
\11\ 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 (Document ID
0047).
\12\ According to the SBA, ``The size standards are for the most
part expressed in either millions of dollars (those preceded by
``$'') or number of employees (those without the ``$''). A size
standard is the largest that a concern can be and still qualify as a
small business for Federal Government programs. For the most part,
size standards are the average annual receipts or the average
employment of a firm. How to calculate average annual receipts and
average employment of a firm can be found in 13 CFR 121.104 and 13
CFR 121.106, respectively'' (SBA, 2019, Table of Small Business Size
Standards--Effective Aug 19, 2019, Document ID 0225)). In December
2022, SBA published an update to the table of small business size
standards. However, the schedule for this final HCS rulemaking did
not allow for a timely adoption of the 2022 table.
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The revisions to the HCS affect establishments in a variety of
different industries in which employees are exposed to hazardous
chemicals or in which hazardous chemicals are produced. The changes to
the HCS do not change the overall list of affected industries or
establishments. However, some changes specifically affect certain
establishment groupings that manufacture aerosols, desensitized
explosives, and flammable gases. Other changes affect certain
manufacturers of hazardous chemicals that are packaged in small
containers and manufacturers of chemicals that are not immediately
distributed after being released for shipment.
The revisions define and revise specific classifications and
categories of hazards, but the scope of the requirements under which a
chemical (whether a substance or mixture of substances) becomes subject
to the standard is not substantially different from the 2012 version of
the HCS. Therefore, OSHA believes that the revisions have little or no
effect on whether specific establishments fall within the scope of the
standard.
OSHA's estimates of the number of employees who will require new
training under the revisions to the standard are based on BLS's (2023)
Occupational Employment Statistics data for May 2022, specifically the
estimates of the number of employees in SOC 51-0000 Production
Occupations and SOC 13-1081 Logisticians working in firms in the NAICS
industries that are affected by the revised requirements to reclassify
aerosols, desensitized explosives, and flammable gases.\13\ (See
the analysis and discussion of training costs below in VI.F.,
Compliance Costs and Cost Savings.)
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\13\ The NAICS industries estimated to be affected by the
revised requirement to reclassify aerosols, desensitized explosives,
and flammable gases are the following: 211130 Natural Gas
Extraction, 324110 Petroleum Refineries, 325110 Petrochemical
Manufacturing, 325120 Industrial Gas Manufacturing, 325320 Pesticide
and Other Agricultural Chemical Manufacturing, 325412 Pharmaceutical
Preparation Manufacturing, 325510 Paint and Coating Manufacturing,
325520 Adhesive Manufacturing, 325611 Soap and Other Detergent
Manufacturing, 325612 Polish and Other Sanitation Good
Manufacturing, 325613 Surface Active Agent Manufacturing, 325620
Toilet Preparation Manufacturing, and 325920 Explosives
Manufacturing. Bureau of Labor Statistics (BLS, 2023). Occupational
Employment Statistics--May 2022 (Released April 25, 2023). Available
at https://www.bls.gov/oes/#data (Accessed April 27, 2023) (Document
ID 0482).
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Table VI-1 provides an overview of the estimated numbers of firms,
establishments, and employees in each covered NAICS industry; the
estimated number of employees in covered occupations (e.g., logistics
personnel); and the estimated numbers of affected firms, affected
establishments, and affected employees in covered occupations.\14\
Tables VI-2 and VI-3, respectively, provide parallel information for
all affected business entities defined as small by the SBA \15\ and all
affected very small business entities, defined by OSHA as those with
fewer than 20 employees. The data in these tables update the estimates
provided in the PEA in support of the 2021 HCS NPRM (Document ID 0258)
and rely on the most recent comprehensive set of data (including
revenues) available from the Bureau of Labor Statistics (BLS, 2023) and
the U.S. Census Bureau (2022a; 2022b; 2022c).\16\
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\14\ The overall percentage of firms, establishments, or
employees affected is based on the largest percentage affected for
any single cost item--as shown in Table VI-10 later in this section.
To estimate the overall number of affected firms, establishments,
and employees, OSHA multiplied the total number of firms,
establishments, and employees by the maximum percentage of firms,
establishments, and/or employees affected by any single provision.
Because most of the NAICS industries shown in the table would be
affected by rule familiarization, this percentage is 100 percent for
most of the NAICS industries shown.
\15\ For the 2019 SBA U.S. Small Business Administration Table
of Small Business Size Standards matched to North American Industry
Classification System Codes (Effective August 19, 2019), see
Document ID 0225. In Table VI-2 in the PEA, the numbers shown for
Total Employees and Employees in Covered Occupations (columns 5 and
6) erroneously understated the correct estimates. However, because
OSHA's underlying calculations utilized the correct estimates, the
errors in that table did not affect compliance cost estimates or any
other results derived in the PEA.
\16\ U.S. Census Bureau, Statistics of U.S. Businesses, 2017
(Document ID 0231; 0232).
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The PEA and Initial Regulatory Flexibility Analysis in the NPRM did
not include the construction industry (NAICS 23) within its scope and
in
written comments the Construction Industry Safety Coalition (CISC)
questioned the basis for the exclusion (Document ID 0335, pp. 2-3). In
response, OSHA notes that the scope and application of the final
standard primarily refers to manufacturers, importers, and
distributors. OSHA anticipates that the compliance burden of this rule,
and therefore the economic impacts, will primarily be borne by the
general industry sectors noted above, and although the construction
industry is not exempted from the scope and application of the final
standard, any economic impact upon construction employers will likely
take the form of downstream effects as consumers of affected chemical
products.
To the extent that there are costs for the construction industry
associated with training workers on new SDSs, OSHA believes that these
costs will be de minimis. As OSHA notes below in the section on
training costs, the agency estimated training costs for health and
safety personnel, but not users of chemicals with new hazards because
OSHA concluded that there would only be a trivial amount of training
associated with reclassification for those users. OSHA's understanding
of the construction industry is that there are relatively few employees
who are affected by the HCS standard who are not users of the
chemicals, and therefore has not taken costs for that industry.
The costs and cost savings of some of the revised provisions (new
classification criteria for select hazards and labels on very small
containers) are driven by the number of SDSs (and labels) that
manufacturers must redesign as a result of the new criteria and the
number of labels on very small containers. In support of the cost
analysis that appears later in this FEA, Table VI-4 presents OSHA's
estimate of the number of labels per container by container size (and
type).\17\ Starting with the fifth row (container type: 250 ml
container), Table VI-4 is drawn from data in a table (Table VI-5)
presented in the FEA in support of the 2012 HCS final rule (77 FR
17639-40), but OSHA has updated the data to include smaller containers
to permit evaluation of the impacts of the small container and very
small container labeling provisions introduced in (new) paragraph
(f)(12). Also, the term ``jug'' has been changed to the more generic
term ``container.'' The figures in Table VI-4 are slightly different
than some of the figures in Table VI-5 of the 2012 FEA due to a change
in OSHA's approach to rounding and the reporting of more significant
digits.
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\17\ As reflected in Table VI-4, OSHA assumes one outer
packaging with an additional label for every two 2.5-gallon
containers; one outer packaging with an additional label for every
four 1-liter, 2-liter and 1-gallon containers; and one outer
packaging with an additional label for every eight containers
smaller than 1 liter. In the PEA, OSHA requested public comment on
the label-container specifications presented in Table VI-4. OSHA
received no comments addressing the specifications proposed in Table
VI-4; therefore, in this FEA Table VI-4 remains unchanged from its
preliminary appearance.
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As will be discussed at greater length below in Section VI.F.,
Compliance Costs and Cost Savings, it has been OSHA's understanding
that chemical manufacturers and importers periodically review, revise,
and update the electronic templates they use to create SDSs and labels.
Changes are made, for example, as information regarding specific
hazards becomes available, new information about protective measures is
ascertained, or revisions are made to product information and marketing
materials. Labels and SDSs are also produced and modified when products
are first introduced to the market or when products change. In the PEA,
the terms ``electronic templates'' and ``electronic files'' were used
interchangeably with, and as proxies for, the term ``SDS.'' All three
terms refer to electronic files that are used to generate SDSs and
labels. Table VI-5 provides, by covered NAICS industry, estimates of
the total number of labels, the number of labels on very small
containers (containers of 3 ml capacity or less), the total number of
SDSs, and the number of labels and SDSs affected by the proposed
revisions to the HCS classification criteria. The term ``SDS'' in the
column headers and in the discussion below represents the
estimated number of electronic templates (files) that are used to
create SDSs and labels. The derivation of these estimates is discussed
below.
OSHA's estimate of the total number of SDSs per NAICS industry, as
presented in Table VI-5, was developed by its contractor to support the
agency's FEA for the 2012 final standard.\18\ The analysis started with
the number of SDSs per establishment by establishment size, as
originally derived in the economic analysis in support of the 2009
proposed HCS rule (Document ID 0029) using a sampling of company
websites and the SDSs posted there.\19\ The analysis then combined the
estimated number of SDSs per establishment by establishment size with
the estimated number of establishments to estimate the weighted average
number of SDSs per establishment in a given NAICS industry. This
estimate was then multiplied by the average number of establishments
per firm to estimate the number of SDSs per firm for each NAICS
industry. Multiplying by the number of firms per NAICS industry yields
the total number of SDSs in each NAICS industry (as shown in Column 5
of Table VI-5).
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\18\ Technical and analytical support for the PEA and this FEA
was provided by Eastern Research Group, Inc. (ERG) under Contract
No. DOL-OPS-16-D-0012.
\19\ This methodology was not challenged by commenters during
the rulemaking that resulted in the 2012 final rule.
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BILLING CODE 4510-26-C
OSHA's preliminary estimate of the number of labels per NAICS
industry was constructed using the same methodology developed in the
2012
HCS final rule (Document ID 0005, pp. 17634-17643), but with more
recent data.
The steps in the analysis, elaborated on below, were summarized in
the PEA as follows:
Begin with data on shipment weight by commodity code and
shipment weight class.
Estimate the average weight per container for containers
of various sizes.
Allocate the tons shipped in each shipment weight class
for certain sizes of containers.
Divide the tons shipped by the average container weight to
estimate total containers.
Multiply the containers by the average number of labels
per container to estimate total labels.
Allot the labels among NAICS codes using receipts data.
(86 FR 9610)
The label analysis in the PEA began with the U.S. Census Bureau and
the U.S. Department of Transportation's jointly produced Commodity Flow
Survey (CFS) (U.S. Census Bureau, 2014a, Document ID 0024) data on
shipment characteristics by commodity and shipment weight. This dataset
includes the number of tons shipped for a range of shipment weight
classes by Standard Classification of Transported Goods (SCTG) code.
The number of tons is converted to pounds, and limited to hazardous
non-consumer products (i.e., those that would have the HCS labeling).
The estimated percentages for the transported goods identified as
hazardous non-consumer products were presented in the 2012 HCS FEA cost
model (See ERG/OSHA, 2012, Document ID 0029). At the time OSHA
developed the PEA, the final 2017 CFS data was not yet available.
Therefore, 2012 CFS data was the most recent information available.
OSHA requested public comments, and received none, on the estimated
percentages for the transported goods identified as hazardous non-
consumer products in the preliminary profile. For this FEA, OSHA has
revised the preliminary percentages of hazardous non-consumer products
to reflect data from the 2017 CFS (U.S. Census Bureau, 2020d, Document
ID 0474), which is the most recent available.
The CFS-based percentage estimates are used in conjunction with
another CFS dataset (U.S. Census Bureau, 2020e, Document ID 0475) that
has shipment data by NAICS industry (but not by shipment weight) to
divide the detailed shipment weight data into shipments coming from
manufacturers and distributors.
The next step in the methodology estimated the representative
weight per container for a variety of types of containers (ranging in
size from a 3-milliliter vial to a rail car) and substances (such as
antifreeze, diesel fuel, paint). Using representative substances, OSHA
estimated the shipment weight for one container of each size as
Shipment Weight = (Product Weight per gallon x Container Capacity) +
Container Weight. Because of a lack of available data establishing the
percentage of products shipped by container type (i.e., the breakdown
of the types of products shipped by each container type), the
calculation for each product and container type relied on professional
judgment (by OSHA and its economic contractor, ERG) to select a
``typical'' product weight per gallon and container weight for each
container type, and no commenters provided data that contradicted this
approach. Next, the analysis estimated shipment weight per container by
multiplying the average product weight per gallon times the number of
gallons per container, plus the container weight.
To convert the CFS data on tons (or pounds) shipped by container
size into a number of containers, the analysis estimated the percentage
of each shipment class likely to be shipped in certain sizes of
containers. Shipments of lower weights are generally estimated to be
shipped in smaller containers, and vice versa. Then the total non-
consumer hazardous pounds shipped (from the CFS data) was multiplied by
the estimated percentage shipped in each container type to yield the
number of non-consumer hazardous pounds in each container type.
Finally, the non-consumer hazardous pounds in each container type were
divided by the average weight per container type to yield an estimate
of the total number of containers.
To estimate the number of labels that would be used on these
containers, the analysis first estimated the average number of labels
on a single container for each container size (from Table VI-4 above).
As previously noted, these estimates account for the fact that some
containers have outer packaging that would require an additional label
under this proposed rule (e.g., kits containing containers less than
100 ml where tags and fold out labels are infeasible) or are shipped
with several containers grouped into a single outer container with a
label. This average number of labels per container for each shipment
size class was then multiplied by the number of containers to estimate
the total number of labels.
The final step in the analysis was to allocate the number of labels
shipped from SCTG codes to NAICS codes. The NAICS-to-SCTG mapping was
adapted from the mapping used in the FEA in support of the 2012 HCS
final rule analysis, but with NAICS categories updated from 2007 to
2017 categories. U.S. Census (2022) Statistics of U.S. Businesses data
was used to estimate each NAICS industry's share of total receipts for
the SCTG code with which it corresponds, and then the number of labels
in each SCTG was allocated proportionally. (This calculation was
performed separately for shipments from manufacturers and from
distributors for purposes of estimating cost savings due to the
proposed released-for-shipment provision in paragraph (f)(11)). This
resulted in the estimated number of labels shown in Column 3 of Table
VI-5.\20\
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\20\ For example, NAICS 211130--Natural Gas Extraction is
categorized as a basic chemicals manufacturer, or Code 20 in the
SCTG commodity coding system. Across the range of container types
and container weights shown in Table VI-4, the analysis led to an
estimate of the total number of labels (600,645,446) required by all
SCTG Code 20 manufacturers (see Document ID 0481, tab ``Labels per
NAICS'', cell O11). The percentage of receipts (30.7 percent) for
NAICS 211130 relative to total receipts for SCTG Code 20 employers
(Document ID 0481, tab ``Labels per NAICS'', cells N11-P11) was then
applied to this total number of labels. The result, shown in Column
3 in Table VI-5, is an estimated 184,330,155 labels for NAICS
2111130. Note that multiplying factors may yield a slightly
different total due to rounding of the factors in the table (but not
in the spreadsheet).
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To estimate the number of labels on very small containers (those on
containers with a volume capacity of 3 ml or less), the same analysis
was performed, but it was limited to containers in that size range. The
resulting estimates of the number of labels on very small containers
are shown in Column 4 of Table VI-5.
Not every SDS and label, and not every label on very small
containers, would be affected by the rule. Only SDSs and labels for
certain products (aerosols, desensitized explosives, and flammable
gases) would be affected by the new classification criteria. And only
certain very small containers would be covered by proposed paragraph
(f)(12)(iii), which would eliminate some labeling requirements in
certain circumstances. In particular, under paragraph (f)(12)(iii),
only a product identifier would be required on very small containers (3
ml or less) where the manufacturer, importer, or distributor can
demonstrate that a label would interfere with the normal use of the
container and that it is not feasible to use pull-out labels, fold-back
labels, or tags containing the full label
information, although the immediate outer packaging would need to
include the full label. Thus, in addition to the estimated total number
of SDSs, labels, and labels on very small containers, Table VI-5 shows
the number of each estimated to be affected by the revised
standard.\21\
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\21\ Note that OSHA's cost estimates for reclassifying affected
chemicals and revising the corresponding SDSs and labels to achieve
consistency with the reclassification (per changes to Appendix B),
and for revising SDSs and labels to conform with new precautionary
statements and other new mandatory language in the appendices to the
HCS (per changes to Appendices C and D), are based on the costs
associated with chemical manufacturers editing their electronic
files (which are used to produce labels and SDSs) for each product
for which reclassification would be required as a result of the
final rule. They are not based on the number of labels or SDSs
produced or used. The number of labels and labels affected by
revision in the tables provided represent the total number produced;
that number is provided to include all relevant information even
though it is not being used in calculating costs.
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Although OSHA preliminarily determined that this methodology
remains sound, in the NPRM the agency invited public comment on the
reasonableness of this methodology for the current analysis and on its
understanding about the use of electronic template files to create SDSs
and labels. One commenter, Ameren Corporation (Ameren), directly
addressed OSHA's nomenclature for SDS electronic files and the ability
of stakeholders to understand the agency's preliminary methodology for
estimating SDSs and labels, with the comment, ``Ameren agrees with
OSHA's understanding of electronic template files to create SDSs and
labels'' (Document ID 0309, p. 5). Another commenter, Michele Sullivan,
noted that ``every HCS SDS will need to be revised'' due to the changes
in Appendix D. As shown in Table VI-5, OSHA already estimates that
almost every SDS will be revised due to the provisions in the final
rule.
Responsible Industry for a Sound Environment (RISE) and CropLife
America (CropLife) noted that the labeling requirements of the HCS do
not apply to pesticides that are regulated under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), but Table VI-5
lists over 23 million labels affected by this revision for the
Pesticide and Other Agricultural Manufacturing industry. RISE and
CropLife requested clarification on this apparent conflict (Document ID
0343, pp. 3-4).
In response to the concerns expressed by the two trade associations
about the number of pesticide labels affected by the revised HCS, OSHA
notes that the agency lacks data indicating what proportion of
chemicals produced by the Pesticide and Other Agricultural
Manufacturing industry fall within FIFRA's definition of pesticide,
which is the category of chemicals exempt from the HCS. The agency has
chosen to err on the side of caution and to the extent that the
preliminary estimate overstates the actual number of labels affected,
any such differential would only over-estimate the costs of the rule.
This assumption has no bearing on the scope of the HCS and the HCS is
clear that pesticides that meet FIFRA's definition are exempt.
Several commenters described the common practices found within
their industry for updating SDSs and labels, which support OSHA's
understanding of the use of electronic templates for SDSs and labels.
The Independent Lubricant Manufacturers Association (ILMA) surveyed
their membership on several of the technical and economic issues raised
in the NPRM. Based on 16 responses to the ILMA survey, all from the
association's manufacturing members, ILMA stated that ``[t]he majority
of ILMA members responding to the survey indicated that they rely on
third-party services to generate SDS and labels, whether it be software
or contracted work'' (Document ID 0460, Att. 1, p. 5).
On the topic of the outsourcing of SDS software development, the
National Association of Chemical Distributors (NACD) polled a few of
their member companies on how employers process SDSs. At least one
member company noted that they outsourced the creation of their SDSs to
a firm that specializes in that work because ``like many NACD members,
most of whom are small businesses,'' their staff do not have time to do
that work (Document ID 0446, p. 2).
The Hach Company (Hach), a manufacturer of chemical reagents and
instruments for water quality analysis, indicated during testimony at
the public hearing and in a post-hearing comment that it used software
it purchased from an outside vendor to create its SDSs (Document ID
0427, pp. 1-2). Tables VI-6 and VI-7, respectively, provide information
on total numbers of SDSs, labels, and labels on very small containers,
and on the numbers of SDSs and labels (including labels on very small
containers) affected by reclassification and the provisions for labels
on very small containers, for all covered small entities and very small
entities.
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Table VI-8 shows average estimated profit rates for affected NAICS
industries based on Internal Revenue Service (IRS) (2016) SOI Tax
Stats--
Corporation Source Book profit data for each of the 14 years 2000-2013.
OSHA's final estimate of average profit rates by six-digit NAICS
industry replicate the agency's preliminary estimate of profit rates
\22\ (Document ID 0004).
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\22\ In the PEA, OSHA requested public comment on the estimated
profit rates presented in Table VI-8. OSHA received no comments
addressing the estimates proposed in Table VI-8; therefore, in this
FEA Table VI-8 remains unchanged from its preliminary appearance.
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Table VI-9 presents OSHA's final estimates of total revenues and
total profits by NAICS industry code for all entities, small entities,
and very small entities affected by the revised standard rule. For this
FEA, OSHA extrapolated the receipts reported in the 2017 Statistics of
U.S. Businesses (SUSB) by NAICS industry to 2022 dollars using the
Bureau of Economic Advisors (BEA) GDP deflator. To assign revenue for
2022 at the six-digit NAICS level, OSHA benchmarked per-establishment
revenue to per-establishment payroll based on 2017 SUSB revenue-payroll
ratios and projected to 2022 dollars using the BEA GDP deflator.
OSHA calculated total profits per NAICS industry by multiplying the
average profit rate (NAICS industry) (Document ID 0004) by total
revenues (NAICS industry) (U.S. Census Bureau, 2022a, Document ID 0476;
U.S. Census Bureau, 2022b, Document ID 0477).
Table VI-10 shows, by NAICS industry code, OSHA's best estimates of
the percentage of establishments or entities affected for each element
of the proposed revisions to the HCS that is projected to result in
costs (see Section VI.F., Compliance Costs and Cost Savings, in this
FEA for an explanation of the cost categories presented in this
table).\23\
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\23\ Note that the provisions that are projected to result in
cost savings are not included in Table VI-10 because, for those
provisions, OSHA estimates a percentage of product, rather than a
percentage of entities or establishments, that would be affected.
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Finally, Table VI-11 summarizes key estimates for the combined
covered industries, labels, and SDSs affected by the final rule. The
data in this table are drawn from profile tables presented earlier in
this FEA and summarize both the magnitude of the global profile metrics
(within the scope of OSHA jurisdiction) and the magnitude of affected
inputs critical to the agency's analysis of the final economic impacts.
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D. Health and Safety Benefits and Unquantified Positive Economic
Effects
As part of the rulemakings that resulted in the promulgation of the
original HCS in 1983 and the 1987 updates, OSHA conducted research to
identify and estimate expected health and safety benefits, as described
in the preambles to those final rules (48 FR 53327-53329; 52 FR 31868-
31869). Combining the estimates from the 1983 rulemaking with those
from the 1987 update, OSHA estimated that the HCS would prevent 31,841
non-lost-workday injuries and illnesses, 20,263 lost-workday injuries
and illnesses, 6,410 chronic illnesses, and 4,260 fatalities annually
(77 FR 17621). In the 2012 final rule to modify the HCS to conform with
the GHS, OSHA estimated that compliance with those revisions to the HCS
would result in additional health and safety benefits equal to 1
percent of the previously-estimated health and safety benefits--that
is, they would result in the prevention of an additional 318 non-lost-
workday injuries and illnesses, 203 lost-workday injuries and
illnesses, 64 chronic illnesses, and 43 fatalities annually (77 FR
17620-17624).
Relative to the HCS rulemakings that resulted in the promulgation
of final rules in 1983, 1987, and 2012, the revisions to the HCS
finalized in this current rulemaking are incremental and minor.
Accordingly, OSHA expects that the revisions to the standard will
result in more modest improvements in employee health and safety than
the estimated benefits OSHA attributed to the earlier rulemakings. But
OSHA expects that the promulgation of the revisions to the HCS will
result in an increased degree of health and safety for affected
employees and a corresponding reduction in the annual numbers of
injuries, illnesses, and fatalities associated with workplace exposures
to hazardous chemicals. Aligning with Rev. 7 will improve worker health
and safety by ensuring the provision of more and better hazard
information to employers and workers. For example, OSHA anticipates
that the improved criteria for aerosols and flammable gases and the new
hazard class for desensitized explosives, along with updated
precautionary statements, will better differentiate the hazards
associated with those chemicals. In addition, the revised released-for-
shipment provisions will remove the risk of injury and chemical
exposures for employees who previously would have confronted the
possibility of, for example, having to break down pallets of sealed,
shrink-wrapped, or packaged containers to replace labels when new
hazards were identified.
Although OSHA expects that the revisions to the HCS will reduce
injuries, illnesses, and fatalities, the limited scope and nature of
the changes being finalized have led OSHA to a determination that it
cannot reasonably quantify an estimate of how many injuries, illnesses,
and fatalities will be prevented. As the agency noted in the 2012 FEA,
any assessment of benefits that are incremental to the original
estimated benefits, e.g., benefits associated with minor improvements
to an existing standard, broadens the range of uncertainty associated
with the original estimates (77 FR 17621).\24\ In the NPRM, OSHA
invited interested parties to provide comments and evidence on how the
proposed revisions to the HCS are likely to affect worker safety and
health.
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\24\ As described above, OSHA estimated that the 2012 revisions
to the HCS would result in benefits equal to 1 percent of the health
and safety benefits previously estimated for the standard (77 FR
17620-17624). In the 2012 rulemaking, OSHA and stakeholders
collectively noted the considerable uncertainty inherent in
estimating benefits that are additional (incremental) to the set of
benefits associated with the original rule (see 77 FR 17620-17624).
The agency stated: ``OSHA believes that a reasonable range for the
magnitude of the health and safety benefits resulting from the
proposed revisions would be between 0.5 percent and 5 percent of the
benefits associated with the current HCS'' (77 FR 17621 (n 14)). In
addition, OSHA stated in the 2012 FEA that ``[i]t is conceivable
that actual benefits might be somewhat lower, but because the GHS is
expected to result, in some situations, in more timely and
appropriate treatment of exposed workers, OSHA expects that actual
benefits may be larger, perhaps several times larger'' (77 FR
17621).
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NABTU commented that the organization ``strongly supports OSHA's
proposal to improve elements of the standard, as it is imperative to
have accurate information available to workers on the hazards of the
chemicals to which they are exposed'' (Document ID 0334, p. 1). NIOSH
commended OSHA for proposing to update the HCS to reflect revisions to
the GHS and for applying ``sound reasoning'' as the basis for using
Rev. 7 as the primary guidance (Document ID 0281, Att. 2, p. 2). Also
voicing broad approval of the proposed standard was the Ameren, who
stated, ``whenever worker knowledge is increased on the hazards of
working with chemicals, such as is done in the proposed revision to the
HCS, worker safety will be increased'' (Document ID 0309, p. 5).
Furthermore, Ameren concurred with OSHA's preliminary assessment of the
benefits of the proposed standard, noting that it agreed with OSHA that
the proposed changes would enhance the clarity and accessibility of
hazard information and workers would receive better training (Document
ID 0309, p. 2).
OSHA received many other comments supporting the positive impact of
specific provisions on worker safety. Several commenters argued that
the proposed changes would reduce worker safety and referred to
specific proposed changes (see, e.g., Document ID 0322, Att. 1, p. 1;
0354, p. 1). OSHA has addressed both kinds of comments and explained
why it disagrees with commenters suggesting that the rule will
negatively impact worker safety throughout the relevant parts of
Section XIV., Summary and Explanation of the Final Rule.
In addition to health and safety benefits, OSHA expects that the
revisions to the HCS will result in other positive economic effects.
For example, being better aligned with the GHS will help facilitate
international trade, thereby enhancing competition, increasing export
opportunities for U.S. businesses, reducing costs for imported
products, and generally expanding the selection of chemicals and
products available to U.S. businesses and consumers. As a result of the
direct savings expected to result from better harmonization and the
associated increase in international competition, prices for the
affected chemicals and products, and the corresponding goods and
services that use them, should decline, even if only to a limited
extent.
Similarly, better alignment between the HCS and the GHS will have
the additional benefit of meeting the international goals for adoption
and implementation of the GHS that have been supported by the U.S.
government.\25\ Maintaining alignment with the GHS in U.S. laws and
policies through appropriate legislative and regulatory action was
anticipated by the U.S. when it supported international mandates
regarding the GHS in the Intergovernmental Forum on Chemical Safety,
the World Summit on Sustainable Development, and the United Nations. It
is also consistent with the established goals of the Strategic Approach
to International Chemical Management that the U.S. helped to craft
(SAICM, 2006, Document ID 0039).
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\25\ The European Union (EU), Canada, Australia, and New Zealand
have also indicated that they are proposing updates to align with
Rev. 7 (Report of the Sub-Committee of Experts on the Globally
Harmonized System of Classification and Labelling of Chemicals on
its thirty-fifth session ST/SG/AC.10/C.4/7, Document ID 0040). For
the history of U.S. government support for adoption and
implementation of the GHS, see the 2012 Final HCS Rule, Document ID
OSHA-H022K-2006-0062-0656, Section II. Events Leading to the Revised
Hazard Communication Standard (77 FR 17577).
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E. Technological Feasibility
In accordance with the OSH Act, OSHA is required to demonstrate
that occupational safety and health standards promulgated by the agency
are technologically feasible. A standard is technologically feasible if
the protective measures it requires already exist, can be brought into
existence with available technology, or can be created with technology
that can reasonably be expected to be developed. See Lead I, 647 F.2d
at 1272.
OSHA has reviewed the requirements that will be imposed by the
final rule and determined that compliance with the final rule is
technologically feasible for all affected industries.
The revisions to OSHA's HCS will require manufacturers and
importers to reclassify aerosols, desensitized explosives, and
flammable gases in accordance with the new classification criteria and
make corresponding revisions to SDSs and labels. Compliance with these
requirements will mainly involve revisions to the presentation of
information and is not expected to involve any technological obstacles.
On the question of the technological feasibility of compliance with
the proposed provisions for reclassification criteria and the
subsequent revisions to SDSs and labels, ILMA expressed concern about
``whether software will even be capable of adopting the proposed rule
changes. Currently, the technology aims to make it easy to select
applicable fields for inclusion in the final SDS, but under the
proposed rule, the software would likely need narrative fields for
explanation, something that is not included in the widely-used
authoring programs'' (Document ID 0460, Att. 1, p. 5). The agency
believes ILMA's membership misunderstands the extent of what was
intended by the addition of clarifying language in paragraph (d), as
discussed elsewhere. Many commenters indicated a belief that the
information required on the SDS would be much more extensive and
comprehensive than OSHA intends. Because these revisions will not in
fact require a fundamental change to how SDSs and labels are prepared,
the agency does not believe that the available software is incapable of
generating compliant SDSs and labels. Additionally, even if ILMA's
understanding of the impact of these revisions was correct, sample
product data sheets and SDSs submitted into the record by NABTU (see,
for example, Document ID 0450, Atts. 2, 3, 4, 6, and 7) indicate that
narrative text is routinely provided in succinct form for sections on
hazard identification and safety warning, and thus there should be
existing software capable of including narrative content, contrary to
ILMA's statement. Further, as an industry partner with a large number
of chemical producers, importers, and distributors, ILMA seemingly
would have access to a wide range of SDSs for chemicals handled by ILMA
members and would therefore encounter multiple examples of the use of
narrative fields in SDS
production. Regardless, even if some programs do not currently have
this feature, a requirement is not technologically infeasible simply
because existing software programs are not tailored to that
requirement. See Lead I, 647 F.2d at 1272. ILMA has not demonstrated
that technological barriers prevent the development of compliant
software or otherwise hinder compliance with the revised requirements
for reclassification criteria on SDSs.
The revised requirements for the labeling of very small containers,
which would eliminate full labeling requirements for some containers
with a volume capacity of three ml or less, are expected to address
current feasibility issues related to labeling these containers. When a
label would interfere with the normal use of the container, and it is
not feasible to use pullout labels, fold-back labels, or tags
containing full label information, the rule will permit the container
to bear only the product identifier, which could be etched onto the
container itself. Similarly, the revised released-for-shipment
provisions will alleviate employer concerns regarding the
practicability of breaking down pallets of sealed, shrink-wrapped
packaged containers to replace labels when new hazards are identified.
OSHA requested public comment on any employer concerns about
technological feasibility associated with the provisions for labeling
very small containers or addressing the relabeling of containers that
have been released for shipment. No commenter challenged the
feasibility of the revised provisions. For comments affirming the
benefits of adopting this new labeling flexibility, see the section on
paragraph (f) in Section XIV, Summary and Explanation of the Final
Rule.
OSHA has determined that compliance with all of the requirements of
the final rule can be achieved with widely available technologies. No
new technologies are required for compliance with the modifications to
the HCS. Therefore, OSHA finds that there are no technological
constraints associated with compliance with any of the provisions in
this final rule.
F. Compliance Costs and Cost Savings
I. Introduction
This section presents OSHA's estimates of the costs and cost
savings expected to result from the revisions to the HCS. The estimated
costs and cost savings are based on employers achieving full compliance
with the new requirements of the rule. They do not include prior costs
and cost savings associated with firms whose current practices are
already in compliance with the revised requirements (where prior
compliance is possible).
The estimated costs and cost savings resulting from the revisions
to the HCS consist of five main categories: (1) the cost of revising
SDSs and labels for select hazardous chemicals to reflect chemical
reclassifications (per changes to Appendix B) and to conform to
language criteria in precautionary statements and other mandatory
language (per changes to Appendices C and D); (2) the cost of
management familiarization and other management-related costs
(associated with all of the revisions to the standard); (3) the cost of
training employees as necessitated by the revisions to the HCS (see
paragraph (h)(1)); (4) the cost savings due to the new released-for-
shipment provision (revisions to paragraph (f)(11)); and (5) the cost
savings from limiting labeling requirements for certain very small
containers (paragraph (f)(12)). The first three categories are
considered to be one-time costs and the last two categories are cost
savings that will accrue to employers annually. Although OSHA in the
PEA preliminarily determined that these were the only elements of the
revisions to the HCS that were expected to result in more than de
minimis costs or cost savings, the agency requested comments on whether
any other changes to the standard could cause employers to incur costs
or obtain cost savings.
The discussion following this introduction addresses public
comments on OSHA's preliminary analysis of compliance costs for each of
the five main cost categories listed above, as well as a section on
costs of the proposed changes regarding trade secrets, which OSHA
received several comments about.
The estimated compliance costs do not include any indirect costs or
impacts that may result from the reclassification or relabeling of
chemicals and products already subject to the HCS, such as possible
changes in production or in demand for products. Theoretically, such
impacts, if any, with regard to possible changes in the uses and
applications of affected chemicals, could result in costs or cost
savings. In the PEA, OSHA requested input from stakeholders on such
changes but received none. Therefore, no costs or other impacts
resulting from significant changes in the use or application of
affected chemicals are assessed in this FEA. This is consistent with
the determination OSHA made with regard to reclassification costs for
the 2012 final rule (77 FR 17625).
This FEA presents compliance costs and cost savings on a consistent
and comparable basis across various regulatory activities and expresses
all costs in annualized terms in the final summation. Annualized costs
and cost savings represent the most appropriate measure for assessing
the longer-term potential impacts of this rulemaking and for purposes
of comparing net costs across diverse regulations with a consistent
metric. In addition, annualized net costs are often used for accounting
purposes to assess the cumulative net costs of regulations on the
economy or specific parts of the economy across different regulatory
programs or across years.
As presented in this FEA (unless otherwise specified), a seven-
percent discount rate was applied to costs and cost savings arising in
future years to calculate the present value of these costs and cost
savings for the base year in which the standard becomes effective, and
the same discount rate was then applied to the total present value
costs, over a 10-year period, to calculate the annualized cost.\26\ The
economic effects using a three-percent discount rate are also provided
in the Excel spreadsheets that support this FEA, which can be found in
the docket (Document ID 0481).
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\26\ OSHA annualized costs for this final rule over a 10-year
period in accordance with E.O. 13563, which directs agencies ``to
use the best available techniques to quantify anticipated present
and future benefits and costs as accurately as possible.'' In
addition, OMB Circular A-4 states that regulatory analysis should
include all future costs and benefits using a ``rule of reason'' to
consider for how long it can reasonably predict the future and limit
its analysis to this time period. The 10-year annualization period
is the one OSHA has traditionally used in rulemakings. Note,
however, that OSHA used a 20-year annualization period for the 2012
HCS final rule (77 FR 17625), but that was because of the 5-year
phase-in of some provisions. This HCS final rule does not have any
phase-in provisions longer than 42 months, supporting OSHA's
decision to use a 10-year annualization period for this FEA. ).
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For the purpose of calculating loaded wage rates, OSHA did not
include an overhead labor cost in the FEA in support of the 2012 HCS
final standard. The Department of Labor (DOL) has since determined that
it is appropriate, in some circumstances, to account for overhead
expenses as part of the methodology used to estimate the costs and
economic impacts of OSHA regulations. For this FEA, in addition to
applying fringe benefits to hourly (``base'') wages, OSHA also applied
an overhead rate when estimating the marginal cost of labor in its
primary cost calculation.
Overhead costs are indirect expenses that cannot be tied to
producing a specific product or service. Common examples include rent,
utilities, and office equipment; however, there is no general consensus
on the cost elements that fit the definition of overhead in the context
of occupational safety and health. The lack of a common definition has
led to a wide range of overhead estimates. Consequently, the treatment
of overhead costs needs to be case-specific. For this FEA, OSHA has
adopted an overhead rate of 17 percent of base wages, which is
consistent with the overhead rate and methodology used for, among
others: (1) sensitivity analyses in the FEA in support of the 2017
final rule delaying the deadline for submission of OSHA Form 300A data
(82 FR 55761, 55765); and (2) the FEA in support of OSHA's 2016 final
standard on Occupational Exposure to Respirable Crystalline Silica (81
FR 16285, 16488-16492).\27\
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\27\ This methodology was modeled after an approach used by the
EPA. More information on this approach can be found at: U.S.
Environmental Protection Agency, Wage Rates for Economic Analyses of
the Toxics Release Inventory Program, June 10, 2002 (Document ID
0046). This analysis itself was based on a survey of several large
chemical manufacturing plants: Heiden Associates, Final Report: A
Study of Industry Compliance Costs under the Final Comprehensive
Assessment Information Rule, Prepared for the Chemical Manufacturers
Association, December 14, 1989 (Document ID 0048).
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To calculate the total labor cost for an occupational category,
OSHA added together three components: base wage + fringe benefits (45
percent of the base wage) \28\ + applicable overhead costs (17 percent
of the base wage). For example, the median hourly wage of an
Occupational Health and Safety Specialist is $37.77. Applying a fringe
markup of 45 percent (applied to the base wage) and an overhead rate of
17 percent (applied to the base wage) yields a fully-loaded hourly wage
of $61.18 ($37.77 x .450 = $17.00; $37.77 x 0.17 = $6.42; $37.77 +
$17.00 + $6.42 = $61.18 (unrounded)). Using this methodology, OSHA
calculated the fully-loaded labor cost for four occupational
categories: (1) Manager, Standard Occupational Classification (SOC)
code 11-0000, $83.62; (2) Logistics Personnel, SOC code 13-1081,
$60.37; (3) Production Worker, SOC code 51-0000, $31.09; and (4)
Occupational Health and Safety Specialist, SOC code 19-5011, $61.18.
(For further details, see Document ID 0481, tab ``Wages''.)
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\28\ In March 2023, the Bureau of Labor Statistics (BLS)
reported: ``Total employer compensation costs for civilian workers
averaged $42.48 per hour worked in December 2022 . . . Wages and
salaries cost employers $29.32 while benefits cost $13.17. . .'' The
fringe markup of 31 percent of total compensation ($13.17/$42.48) is
equivalent to a benefits markup of 45.0 percent (technically 0.449,
or 0.45 after rounding) in relation to the base wage ($13.17/
$29.32). (BLS, 2022b, Document ID 0471).
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Table VI-12 shows the estimated annualized compliance costs and
cost savings by cost category and by industry sector. All costs and
cost savings are reported in 2022 dollars. As shown in Table VI-12, the
total annualized net cost savings of compliance with the final rule is
estimated to be $29.8 million--consisting of about $5.1 million of
annualized costs and $35.0 million of annual cost savings. Note that
where tables in this FEA report estimated annualized costs, as in Table
VI-12, cost savings appear as a negative number.
As shown by the three-digit NAICS Subsectors 325 (for Chemical
Manufacturing) and 424 (for Merchant Wholesalers, Nondurable Goods) in
Table VI-12, most of the estimated compliance costs and cost savings
associated with the final rule will be incurred or realized by the
chemical manufacturing industry and its distributors. However, the
table also shows that familiarization costs will be spread across most
manufacturing and wholesale industries in the U.S. economy subject to
OSHA's jurisdiction, reflecting the fact that employee exposures to
hazardous chemicals occur in many industry sectors.
For purposes of annualizing costs for this FEA, OSHA estimated that
all compliance costs will be incurred in the first year. This
simplifying methodological assumption may upwardly bias the compliance
costs for chemical reclassification, revised precautionary statements,
management familiarization, and training, insofar as the final rule
schedules compliance dates in phases of 18 months, 24 months, 36
months, and 42 months after the effective date. Nonetheless, despite
the simplifying assumption of an immediate implementation of all
provisions in the final rule, OSHA believes that its final
determination of economic feasibility and regulatory flexibility
certification is supported by the rulemaking evidence.
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II. Estimation of Compliance Costs and Cost Savings
The remainder of this section explains how OSHA calculated the
estimated compliance costs and cost savings arising from the final rule
by describing the data and methodology used and addresses relevant
comments from stakeholders.
As explained above, the major elements of the revisions to the HCS
that involve compliance costs or cost savings are: (1) the cost of
revising SDSs and labels for select hazardous chemicals to reflect
chemical reclassifications (per changes to Appendix B) and to conform
to language criteria in precautionary statements and other mandatory
language (per changes to Appendices C and D); (2) the cost of
management familiarization and other management-related costs necessary
to ensure compliance with the revised standard (associated with all of
the revisions to the standard); (3) the cost of training employees as
necessitated by the changes to the HCS (see HCS 2012 paragraph (h)(1));
(4) cost savings from the new released-for-shipment provision
(revisions to paragraph (f)(11)); and (5) cost savings from limiting
labeling requirements for certain very small containers (new paragraph
(f)(12)).
The estimated compliance costs and cost savings presented in this
analysis of the revisions to the HCS are based partly on analysis
conducted in support of the 2012 HCS final rule (77 FR 17605-17683) and
partly on new analysis prepared with the assistance of OSHA's
contractor, ERG.
The estimated costs of compliance with most provisions of the final
rule involve wages paid for the labor hours required to fulfill the
requirements. In some cases, compliance could be achieved by purchasing
services or products in lieu of paying employees directly. The
estimated compliance costs are intended to capture the resources
required for compliance regardless of how individual establishments may
choose to achieve compliance.
With the exception of the provisions addressing precautionary
statements and other mandatory language, for this cost analysis OSHA
estimated a baseline compliance of zero percent. The agency's estimate
of baseline compliance for the revisions in Appendices C and D
addressing precautionary statements and other mandatory language are
discussed below in the section titled Revisions to SDSs and Labels Due
to Revised Precautionary Statements.
III. Costs Associated With Reclassifications and Revisions to Safety
Data Sheets and Labels
The revisions to the HCS will not change the existing requirement
for firms that sell hazardous chemicals to employers to provide
information about the associated hazards. Information must be presented
in an SDS in the format specified in the standard, and some information
must also be presented on product labels. The final rule will require
affected chemical manufacturers to revise SDSs and labels for select
hazardous chemicals to reflect chemical reclassifications (Appendix B)
and to conform to language criteria in precautionary statements and
other mandatory language (Appendices C and D).
It is OSHA's understanding that chemical manufacturers and
importers periodically review, revise, and update the electronic
templates they use to create SDSs and labels. Changes are made, for
example, as information regarding specific hazards becomes available,
new information about protective measures is ascertained, or revisions
are made to product information and marketing materials. Labels and
SDSs are also produced and modified when products are first introduced
to the market or when products change. Therefore, there is a regular
cycle of change for these documents (see the FEA of the 2012 final rule
(77 FR 17634-17637) for a discussion of factors that compel employers
to update SDSs and labels voluntarily). OSHA received comments from the
American Cleaning Institute (ACI) indicating that a longer compliance
window would facilitate companies only needing to make one round of
revisions to their labels because if a company knows they already need
to make one revision to an SDS or label within a certain window of time
they will make all changes at the same time, thereby reducing costs
(Document ID 0424, Tr. 53-54). As explained in the paragraph (j)
discussion in Section XIV., Summary and Explanation of the Final Rule),
OSHA is extending the phase-in period beyond what the agency proposed
in the NPRM.
Also similar to the rule in 2012, OSHA anticipates that many firms
have implemented or are beginning to implement hazard
reclassifications, SDS revisions, software modifications, and other
changes associated with this proposed rule, because these provisions
are generally anticipated to be adopted as part of the implementation
of the GHS in countries and regions around the world and Canada has
already amended the HPR to align with Rev. 7. Since some other
countries are already implementing the GHS, companies in the U.S. that
ship to those countries are already having to comply with the GHS for
products being exported (77 FR 17636).
The final rule requires limited changes to some SDSs and labels.
Given the phase-in period for the changes to the standard,\29\ which
OSHA has extended from what was proposed in the NPRM, the agency
expects that chemical manufacturers and importers will be able to phase
in revisions to their labels and SDSs in accordance with the normal
cycle of change, and therefore will not need to replace existing labels
or SDSs.
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\29\ The final standard requires that the revisions become
effective 60 days after publication (paragraph (j)(1)); chemical
manufacturers, importers, and distributors evaluating substances
comply with all modified provisions within eighteen months after the
effective date (paragraph (j)(2)(i)); employers updating alternative
labeling, hazard communication programs, and training for substances
comply with all modified provisions within two years after the
effective date (paragraph (j)(2)(ii)); chemical manufacturers,
importers, and distributors evaluating mixtures comply with all
modified provisions within three years after the effective date
(paragraph (j)(3)(i)); and employers updating alternative labeling,
hazard communication programs, and training for mixtures comply with
all modified provisions within three and a half years (paragraph
(j)(3)(ii)).
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OSHA has, however, estimated costs for the time it will take to
update the electronic files that will be used to generate new SDSs and
labels in accordance with the revisions to the HCS. OSHA developed cost
estimates based on the methodology used in its FEA in support of the
2012 HCS final rule (77 FR 17634-17637). The estimated compliance costs
represent the incremental costs that will be incurred to achieve
compliance with the final rule. These estimated costs will be in
addition to the costs that already need to be incurred to comply with
applicable requirements of the 2012 HCS that remain in place and
represent the time it will take to identify the changes that need to be
made to the relevant computer files (i.e., the files that are used to
generate SDSs and labels) and then to make those changes.
Producers of affected chemicals already had an obligation under the
2012 HCS, which continues unchanged in this final rule, to ensure that
the information provided in their SDSs and labels is accurate and
current (paragraphs (f)(2) and (g)(5)). They also are generally
required to revise SDSs and labels in accordance with new information
regarding hazards that may be associated with their products
(paragraphs (f)(11) and (g)(5)). For every affected product that is
newly created, reformulated, mixed with new ingredients, modified with
new or different types of additives, or has any changes made in the
proportions of the ingredients used, chemical manufacturers and
importers are required, under the 2012 HCS and this final rule, to
review the available hazard information (paragraph (d)(2)), to classify
the chemical in accordance with applicable hazard criteria (paragraph
(d)(1)), and to develop corresponding SDSs (paragraph (g)) and labels
(paragraph (f)). OSHA is not estimating costs for activities already
required; rather, the agency is estimating costs for activities that
will be newly conducted in conformance with the proposed revisions to
chemical reclassifications (Appendix B) and language criteria in
precautionary statements and other mandatory language (Appendices C and
D).
IV. Revisions to SDSs and Labels Due to Chemical Reclassification
In the PEA, OSHA identified the NAICS industries involved in the
manufacture of aerosols, desensitized explosives, or flammable gases
and affected by the proposed requirements for chemical
reclassification. Of course, not all chemicals covered in these NAICS
industries are aerosols, desensitized explosives, or flammable gases.
In the PEA, OSHA estimated that approximately 50 percent of the SDSs
(or more specifically, 50 percent of the electronic templates (files)
that are used to produce SDSs and labels) \30\ in these NAICS
industries would be affected by the proposed requirements for aerosols,
desensitized explosives, and flammable gases.
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\30\ In this section OSHA uses the terms ``SDSs'' and ``SDSs and
labels'' interchangeably because the agency's understanding is that
one electronic file is used, from which both SDSs and labels can be
generated, and therefore there is not a separate calculation of the
number of electronic files for labels.
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OSHA in the PEA derived the number of directly affected electronic
files for SDSs and labels by applying the 50 percent factor to the
overall number of affected SDSs (electronic files). For example, in
NAICS 211130, the overall number of affected SDSs (technically, the
number of electronic files) was 15,810 (Table VI-5 in the PEA).
Applying a factor of 50 percent, OSHA estimated the number of SDSs
(electronic files) that would be directly affected by the
reclassification provision as 7,905. All of the preliminary estimates
of directly affected SDSs (electronic files) were similarly derived
from Table VI-5 (in the PEA), but only those NAICS industries with
affected SDSs (electronic files) were reported in the PEA.
The estimated compliance costs associated with the reclassification
of hazards and related changes to SDSs and labels are directly related
to the number of chemicals for which electronic files will need to be
updated in order to prepare updated SDSs and labels. OSHA developed
estimates of the number of potentially affected SDSs for each of the
industries producing the corresponding chemicals and products (based on
estimates of the total number of SDSs (and the supporting electronic
files) by industry as shown in Table VI-5). In the PEA, OSHA expected
that downstream users, distributors, and wholesalers would continue to
rely on SDSs and labels provided by manufacturers to fulfill their
obligations under the OSHA standard and would not incur costs
associated with chemical reclassification under the proposed revisions
to the HCS. It was OSHA's understanding that this has been the practice
for decades, and no comments in the record challenged that
understanding.
In the PEA, OSHA presented preliminary estimates of the amount of
time the agency expected it will take to update electronic files for
SDSs and labels under the proposed revisions to the standard. OSHA
believed that the estimates provided in the PEA were reasonable because
they reflected only the incremental time needed to identify affected
labels and SDSs (electronic files) and to update electronic files
through modification of the templates that are used to prepare labels
and SDSs, without allocating costs to any time that would be spent
updating files in the absence of any revisions to the HCS.
OSHA also believed that the estimated time to update SDSs and
labels (electronic files) used in this analysis represented a
reasonable average for most chemicals. In the FEA in support of the
2012 HCS final rule (77 FR 17635-17637), OSHA estimated that a Health
and Safety Specialist would spend between three and seven hours per SDS
requiring reclassification--with smaller entities, having fewer SDSs,
incurring larger costs per SDS. The revisions to the HCS in this final
rule are significantly more limited in scope than the 2012 final rule,
with fewer affected hazard categories and more limited changes;
however, they still present opportunities for scale efficiencies in
reclassification. As a result, OSHA estimated that a Health and Safety
Specialist would spend about 25 percent as much time to reclassify a
chemical as OSHA estimated for the 2012 HCS rule--depending on
establishment size, from 0.75 hours to 1.75 hours per SDS (electronic
file) requiring reclassification (1.75 hours per SDS for establishments
with fewer than 100 employees; 1.25 hours per SDS for establishments
with 100-499 employees; and 0.75 hours per SDS for establishments with
500 or more employees).\31\ At a loaded hourly wage (including
overhead) of $58.00 for a Health and Safety Specialist, this resulted
in unit costs in the PEA of $101.51, $72.51, and $43.50 per SDS for
small, medium, and large establishments, respectively. Multiplying
these unit costs by the estimated number of affected chemicals (i.e.,
electronic files) and summing the totals yielded an undiscounted one-
time estimated cost of $6.4 million for affected employers to comply
with this provision. Annualizing this one-time cost using a seven
percent discount rate over a ten-year period results in estimated
annualized costs of approximately $915,095. OSHA invited public
comments on its preliminary projection that 50 percent of the
electronic files for SDSs and labels would be affected in these
industries and the other preliminary assumptions and unit estimates
presented in the PEA and described above.
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\31\ Note that OSHA estimated no baseline compliance for
chemical manufacturers already having revised electronic files to
reflect reclassified chemicals as specified in the proposed rule;
the current HCS does not allow SDSs or labels to display chemical
classifications that are not in conformance with the current rule.
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OSHA received some comments on its general analysis in this
section. NACD characterized the updates to SDSs as ``a major
undertaking for chemical manufacturers and distributors'' and further
noted, ``[t]aking into account not only the actual updates to these
documents by vendors or company personnel, but also company staff
review time, supply chain communications, and training, NACD members
estimate that the cost of updating a single SDS ranges from $400 to
nearly $1600'' (Document ID 0465, p. 2).
As noted earlier in this FEA, ILMA surveyed its members on impacts
of the proposed standard. On the question of the incremental costs of
updating SDSs, ILMA submitted the following summary of survey
responses. They noted that, of 16 respondents, 12 indicated they
authored 400 or more SDSs (one company reported between 7,000 and
8,000), and that they estimated the cost
of updating each SDS as $400-600. They also stated that ``Some
respondents to the survey noted that, while updates to labels and SDS
occur on a regular basis, these updates usually involve editorial
changes made to incorporate information such as name changes. Therefore
. . . the $400-$600 cost estimate to review each and every SDS needs to
be included as incremental costs, as those costs would not be part of
the companies' `routine' compliance costs'' (Document ID 0444, Att. 1,
pp. 1-2).
In their comments, the North American Insulation Manufacturers
Association (NAIMA) described the contractual arrangements and
operational practices typically conducted by their members when there
arises the need for updating SDSs and labels. In particular, they noted
that every time a change is made to a label, the manufacturer must
redesign the entire label to make sure it all fits on the packaging,
which is expensive, and some label printers still use printing plates
which need to be replaced. They also noted that they spent time
reviewing materials received from contractors and getting labels
translated into other languages, and that there were often costly
delays in receiving packaging materials. They argued that OSHA needed
to account for these costs (Document ID 0461, pp. 3-4). Several
commenters discussed costs of labels specifically. The American
Coatings Association (ACA) testified that member employers would incur
substantial additional expense to update labels if the proposed
revisions were published as the final rule and stated that members had
indicated costs between $300,000 and $800,000 to update their labels
alone. They also noted that disposal of existing labels can be two to
three percent of labeling costs and that small businesses cannot absorb
these costs as operating expenses (Document ID 0425, Tr. 109-110).
Similarly, Ameren stated ``Ameren would incur an additional cost for
having to re-print and replace current labels based on the new OSHA
changes. The cost is estimated at $5 [m]illion and would take over two
years to complete'' (Document ID 0309, p. 5). OSHA notes that ACA and
Ameren did not provide details underlying their estimates so the
magnitude and severity of the cost increase cannot be evaluated by OSHA
without further information on baseline costs and company revenue that
factor into these estimates. Moreover, the final standard does not
include the proposed requirement that a released-for-shipment date
appear on the label, which will lower the labeling costs for
manufacturers, importers, and distributors compared to what they
anticipated at the time comments were submitted.
The Sporting Arms and Ammunition Manufacturers' Institute (SAAMI)
voiced concerns similar to those of ACA with regard to labeling costs
and noted the costs of new printing plates and disposal of existing
labels, particularly for manufacturers who may have as many as 4,000
products that need to go through this process (Document ID 0423, Att.
1, Tr. 84). Hach also noted skepticism regarding the idea that these
costs could be absorbed under the normal costs of business, partly due
to the limited space on their labels (Document ID 0425, Tr. 102). Hach
further commented on the costs of the proposed rule by providing
information on its cost data for SDS templates provided by a software
service vendor. They provided data on two different vendors, one of
which cost $230,000 to purchase, $120,000 in annual maintenance costs
for global regulatory updates and another $1,100 for annual maintenance
specific to SDSs for the United States. The other vendor cost $60,215
for the initial implementation of the templates and $100,825 for an
annual license (Document ID 0427, p. 2).
OSHA does not agree with these commenters' arguments that the
preliminary cost analysis did not account for the costs for new or
updated printing plates, the disposal of existing labels, and other
operational changes associated with the proposed revisions to the
reclassification requirements in HCS. As noted earlier, OSHA's
understanding is that in many cases responsible parties would have
needed to update their SDSs and labels within the extended compliance
time frame even if there were no updates to the HCS, and therefore some
of these costs (such as label disposal and new printing plates) would
already be incurred. The agency expects that responsible parties will
fold the HCS updates into those standard updating cycles so that they
only need to incur these costs once and this means the HCS updates are
not creating those costs. Therefore, OSHA is not persuaded that the
compliance burden described by the stakeholders discussed above will
exceed the customary and usual business practices or the business
practices expected during the implementation timeline prescribed in
final paragraph (j) for chemical employers affected by the final rule
and is thus not taking additional costs for those issues. OSHA is,
however, adjusting the time it expects it to take responsible parties
to update the electronic SDS and label files, partly based on the
content of these comments (see discussion below).
OSHA also received several comments expressing concerns regarding
the economic costs of the proposed language in paragraph (d)(1). The
United States Beet Sugar Association, the National Grain and Feed
Association, the North American Millers Association, Corn Refiners
Association, the National Oilseed Processors Association, and the
United States Chamber of Commerce (USBSA et al.) stated that the
proposed language in (d)(1) would ``greatly increase the cost of
chemical classification'' (Document ID 0325, p. 9). The American
Chemistry Council (ACC) surveyed their membership to identify and
characterize current practices on communicating hazards within their
industry. Based on that information, ACC stated that OSHA had failed to
account for hazard classification costs associated with the proposed
revisions to paragraph (d)(1), including the large number of SDSs that
would need to be changed, the amount of time required to produce the
SDSs, and the software costs associated with needing new or updated
technology to comply. They argued that this could cost manufacturers
and importers millions of dollars (Document ID 0468, pp. 3-5). The ACC
survey results included statements from their membership with estimates
about the time and costs associated with the proposed paragraph (d)(1),
including an estimate that it would take about 16 hours to update each
SDS and about 50 percent of products would require communication with
customers to ascertain downstream uses, which would result in an
additional 17,500-70,000 hours of work. Concern was also expressed that
this would cover as many as 5,000-7,000 products that were not
previously within the scope of the HCS (Document ID 0468, p. 10).
The NAIMA expressed concerns about the proposed implementation
schedule and the costs of compliance moving forward under the proposed
language in paragraph (d)(1). Specifically, they noted ``it appears
that every newly discovered hazard of the substance identified by a
chemical manufacturer's ongoing investigation of downstream hazards
would trigger the three- and six-month updating provisions of the HCS
for SDSs and labels, which could lead to a continuous series of
reclassifications triggering those updating requirements'' and argued
that ``[e]ach SDS revision cascading down would incur costs which do
not seem to have been adequately accounted in OSHA's cost-
benefit analysis'' (Document ID 0461, p. 2).
The American Composite Manufacturers Association (ACMA) stated that
the proposed changes to paragraph (d)(1) would result in upstream
chemical suppliers needing to perform a hazard analysis similar to what
is required under OSHA's Process Safety Management of Highly Hazardous
Chemicals (PSM) standard and that ``[t]he [process hazard analyses
(PHAs)] that would be required by OSHA's proposed change to
1910.1200(d)(1) would extend to every hazardous chemical in the U.S.
and would cover every use of a flammable liquid or gas as a fuel.''
They also noted that ``[a]ccording to EPA, the TSCA chemical inventory
contains 86,557 chemicals of which 41,864 are active. Any reasonably
chosen ratio of the number of active hazardous chemicals in the EPA
inventory to the 110 HHCs covered by the PSM standard suggests the
costs of compliance with OSHA's proposed change to 1910.1200(d)(1)
would be enormous'' (Document ID 0318, p. 8). OSHA notes that ACMA also
asserted in their comment that the proposed language in paragraph
(d)(1) is economically infeasible but did not provide financial data to
corroborate the assertion. As explained in Section G of this FEA, OSHA
has determined based on the record evidence that the requirements of
this final rule are economically feasible.
The Plastics Industry Association (PLASTICS) also likened the
proposed language in paragraph (d)(1) to PHAs and discussed the
associated burden of collecting the process safety information for
``nearly one million hazardous chemical products . . . previously
estimated . . . to be in U.S. workplaces'' as well as the need to
determine foreseeable emergencies, ``some of which may produce new
chemicals'' (Document ID 0314, Att. 1, p. 12) (footnote omitted). They
indicated that such a requirement would require upstream suppliers to
hire personnel to collect the necessary information as well. They
argued that OSHA needed to incorporate the costs of this provision and
stated that OSHA had not done so (Document ID 0314, Att. 1, pp. 10-12).
They stated that ``[f]or a chemical with broad applications,
classifying it to include all of the classified hazards of every
downstream reaction, and then creating an SDS to cover all of these
issues would be a monumental, infeasible and counterproductive task.''
(Document ID 0467, p. 21). ACC's survey of its members also discussed
the role of PHAs in company operations and the rigorous procedures
necessary to develop and communicate such analyses (Document ID 0468,
pp. 6-7).
In the Summary and Explanation for paragraph (d), OSHA responds to
the concerns voiced by stakeholders about the scope of paragraph (d)
and the comparisons to PHAs. In its response, OSHA states that it did
not intend for an upstream supplier or manufacturer to identify and
classify every single hazard associated with the downstream use of
chemicals, only those where the manufacturer knows or can reasonably
anticipate the chemical's uses. OSHA has changed the language in
paragraph (d)(1) from the proposed language in the NPRM to clarify this
scope and concludes that many of the comments discussing the economic
ramifications of this proposed language were based on this
misunderstanding of what OSHA intended SDS and label preparers to do.
In response to the comments on OSHA's preliminary unit cost
estimates for chemical reclassification on SDSs and labels in relation
to paragraph (d)(1), the agency has reviewed the preliminary number of
affected SDSs and labels and the preliminary time estimates for
updating and expanding the use of SDSs and labels.
As noted earlier, OSHA in the PEA derived the number of directly
affected electronic files for SDSs and labels by applying the 50
percent factor to the overall number of affected SDSs (electronic
files) from Table VI-5. None of the public criticisms quoted above
specifically referenced the 50 percent factor. Many of the commenters
indicated that they believed the HCS updates to paragraph (d)(1) would
impact many more SDSs than OSHA accounted for in its PEA but, as OSHA
states in the Summary and Explanation for paragraph (d), this
requirement already existed under the 2012 HCS and the language in
paragraph (d) is merely a clarification of the existing requirements.
Because many commenters misinterpreted the scope of what OSHA was
proposing, the agency does not believe these comments are
representative of the number of SDSs that will need to be updated and
the agency does not take costs associated with clarifications that do
not change the underlying requirements of the standard. Therefore, for
this FEA OSHA has maintained the percentage factor of affected SDSs and
labels estimated in the PEA at 50 percent and the industries it expects
will be impacted by reclassification requirements.
As discussed earlier in this section, OSHA presented in the PEA
estimates of the amount of time it will take to update electronic files
for SDSs and labels under the proposed revisions to the standard.
OSHA's estimates in the PEA reflected the agency's initial assessment
of the incremental time needed to identify affected labels and SDSs
(electronic files) and to update electronic files through modification
of the templates that are used to prepare labels and SDSs, without
allocating costs to any time that would be spent updating files in the
absence of any revisions to the HCS.
In the FEA in support of the 2012 HCS final rule (77 FR 17635-
17637), OSHA estimated that a Health and Safety Specialist would spend
between three and seven hours per SDS requiring reclassification--with
smaller entities, having fewer SDSs, incurring larger costs per SDS.
The revisions to the HCS in this final rulemaking are significantly
more limited in scope than the 2012 final rule, with fewer affected
hazard categories and more limited changes; nonetheless, based on
public comments, OSHA recognizes that affected employers may face
adjustments to their schedule for updating SDSs and labels due to
chemical reclassification. OSHA also recognizes based on comments that
it may have underestimated in the 2012 HCS FEA and the 2021 PEA the
time and costs associated with identifying hazards from downstream
uses. While those costs have already been incurred for all existing
products because this is an existing requirement, OSHA recognizes that
for the products undergoing reclassification (aerosols, flammable
gases, and desensitized explosives), these costs will be incurred again
and is therefore adjusting upwards its time estimates. As a result,
OSHA in this FEA estimates that a Health and Safety Specialist would
spend about 30 percent (increased from 25 percent in the PEA) as much
time to reclassify a chemical as OSHA estimated for the 2012 HCS rule--
depending on establishment size, from 0.90 hours to 2.10 hours per SDS
(electronic file) requiring reclassification (2.10 hours per SDS for
establishments with fewer than 100 employees; 1.50 hours per SDS for
establishments with 100-499 employees; and 0.90 hours per SDS for
establishments with 500 or more employees).\32\ At a loaded hourly wage
(including overhead) of $61.18 for a Health and Safety Specialist, this
would result in unit costs of $128.48, $91.77, and $55.06 per SDS for
small, medium, and large establishments, respectively.
Multiplying these unit costs by the estimated number of affected
chemicals (i.e., electronic files) and summing the totals yields an
undiscounted one-time estimated cost of $8.2 million for affected
employers to comply with this provision. Annualizing this one-time cost
using a 7 percent discount rate over a 10-year period results in
estimated annualized costs of approximately $1,168,932 for
reclassification in accordance with the criteria specified in the
revisions to the HCS.
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\32\ Note that OSHA estimated no baseline compliance for
chemical manufacturers already having revised electronic files to
reflect reclassified chemicals as specified in the final rule; the
current HCS does not allow SDSs or labels to display chemical
classifications that are not in conformance with the current rule.
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OSHA does not agree, however, with commenters who argued that the
proposed language in paragraph (d)(1) would create burdens that are
cost prohibitive. First, as discussed, the requirement to classify
based on downstream hazards already existed and OSHA is simply
clarifying that requirement by adding this language to paragraph
(d)(1). Additionally, OSHA received comments and testimony from several
entities regarding existing SDSs that include information about
downstream hazards and companies that maintain product stewardship
programs to address these issues. NABTU cited field observation of
companies who routinely include on SDSs and labels information on
reasonably anticipated downstream use of products: ``[i]t is . . .
worth noting that there are companies producing building materials that
are responsibly anticipating the downstream uses of their products and
creating product stewardship programs aimed at improving recognition
and control of hazards during the life cycle of their products. Where
it is reasonable to assume that manufacturers can anticipate their
products' `normal conditions of use,' it is equally reasonable--and
critically important--to require those manufacturers to include the
attendant chemical reaction hazard information on their SDSs and
labels, and to do so in a consistent manner'' (Document ID 0464, p. 5).
NIOSH stated that they are aware of more manufacturers developing
this type of product stewardship to inform downstream users (Document
ID 0423, Tr. 39; 0456, Att. 2, p. 2). ACC also submitted information on
several product stewardship programs their organization undertakes to
inform downstream users of potential hazards that may result upon use
of their chemicals (Document ID 0468, p. 5). ACC product stewardship
resources include technical and regulatory data sheets, literature,
product handling guidelines, site visits, and special instructions for
safe handling of materials of more concern (Document ID 0468, p. 5).
These comments highlight the significant and ongoing stewardship
initiatives among chemical producers, importers, and distributors and
substantiate OSHA's preliminary judgment of the economic feasibility of
the revised HCS standard. Therefore, in OSHA's view, the modest
adjustment to the preliminary unit cost estimate in this FEA reflects,
in approximate terms, current industry practices in the
reclassification of chemical hazards on SDSs and labels.
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BILLING CODE 4510-26-C
V. Revisions to SDSs and Labels Due to Revised Precautionary
Statements, etc.
The revisions to the HCS require establishments to revise their
electronic templates for SDSs and labels to conform to formatting and
language criteria in precautionary statements and other mandatory
language specified in Appendices C and D. Under the changes to the
standard, affected establishments must update labels and SDSs for
select hazardous chemicals to include updated signal word(s), hazard
statement(s), pictogram(s), and precautionary statement(s) for each
hazard class and associated hazard category (see paragraphs (f) and
(g)). The modification of SDSs and labels under the revisions in
Appendices C and D involves conforming to formatting and language
standards, but does not require any testing, studies, or research. As
previously stated, OSHA believes that chemical manufacturers and
importers generally review, revise, and update their electronic
templates for SDSs and labels periodically, such that there is a
regular cycle of change for these documents.\33\ The changes to the
appendices require only limited changes to the electronic content of
SDSs and labels, and, as explained previously and in the PEA, OSHA
expects that the phase-in period for the changes to the standard will
allow chemical manufacturers and importers to take advantage of the
normal cycle of change to phase in the revisions to their labels and
SDSs, and therefore that it will not be necessary to replace existing
labels or SDSs. OSHA also believes that the extended phase-in period
will accommodate the need for the purchase of software packages or
renewal of licenses for SDSs and labels, impacts noted by ILMA at the
public hearings (Document ID 0404, Att. 1, p. 2).
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\33\ See discussion in the preamble to the 2012 HCS final rule
(77 FR 17634).
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The estimated compliance costs for revising electronic templates
for SDSs and labels to conform to formatting and language criteria in
precautionary statements and other mandatory language specified in the
revisions to Appendices C and D represent the incremental costs that
will be incurred to achieve compliance with the final changes to the
appendices. In the PEA, OSHA estimated that the time needed to revise
electronic templates for labels and SDSs to comply with the proposed
revisions to Appendices C and D would vary by establishment size and
would be equal to 10 percent of the unit time (from three to seven
hours per SDS (electronic template)) estimated in the 2012 FEA (77 FR
17635-17637), as the changes the proposed revisions would require are
relatively minor in comparison to the types of changes costed in
2012.\34\ OSHA estimated that Health and Safety Specialists would spend
0.7 hours per SDS (electronic template) in small establishments with
fewer than 100 employees; 0.5 hours per SDS in medium establishments
with 100 to 499 employees; and 0.3 hours per SDS in large
establishments with 500 or more employees to comply with the proposed
mandatory changes to Appendices C and D.
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\34\ By comparison, the 2012 rule changes included completely
revised SDS formats, the addition of pictograms, and various other
revisions for specific SDS sections and chemical designations. Note
that there are no estimated new software costs associated with the
proposed revisions to the standard, as there were for the 2012 final
rule, because OSHA expects that the necessary software is already in
place in those larger firms for which the software is economically
justified.
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As in the FEA for the 2012 HCS final rule, OSHA anticipates that
some manufacturers, particularly larger ones heavily involved in
international trade, are more likely because of their size to have
created SDSs and labels that need to be GHS-compliant and therefore are
likely to have already adopted the mandatory language proposed in
Appendices C and D. For the affected NAICS industries, OSHA estimates
baseline compliance rates of 75 percent for establishments with 500 or
more employees, 25 percent for establishments with 100 to 499
employees, 5 percent for establishments with 20 to 99 employees, and 1
percent for establishments with fewer than 20 employees.\35\ These
baseline compliance rates are the same ones OSHA used in the 2012 FEA
(77 FR 17636).
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\35\ As noted above, because the current HCS does not allow SDSs
or labels to display chemical classifications that are not in
conformance with the current rule, OSHA estimated no baseline
compliance for chemical manufacturers already having revised
electronic files to reflect reclassified chemicals as specified in
the proposed rule. With respect to the mandatory language proposed
in Appendices C and D, however, SDSs and labels could present
standards stricter than seen under previous GHS revisions (for
example, if mandatory language is adopted internationally by
consensus) and still remain in conformance with the current HCS
standard. Therefore, baseline compliance can be non-zero for
industry practices involving use of precautionary statements and
other mandatory language.
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Multiplying the number of affected SDSs (electronic files) by the
unit cost of Health and Safety Specialists, and accounting for the
relevant non-compliance rates,\36\ results in an estimated total one-
time cost of $18.9 million associated with revising SDSs and labels to
conform to the proposed appendix language on precautionary statements
and other mandatory language. Annualizing this one-time cost using a
seven percent discount rate over a 10-year period results in estimated
annualized costs of approximately $2.7 million for affected employers
to revise SDSs and labels to comply with the proposed revisions to
Appendices C and D.
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\36\ That is, mathematically, (1--the relevant baseline
compliance rate). Estimated non-compliance rates are shown in Column
6 of Table VI-14 by employment size for each affected NAICS
industry.
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OSHA requested comments on the preliminary unit cost estimates and
other underlying assumptions for the preliminary cost analysis of
revisions to the mandatory appendices. There were no comments
specifically addressing the unit cost estimates and other
methodological assumptions underlying OSHA's preliminary cost estimate.
Earlier in this FEA, OSHA responds to the comments voiced by
commenters about label costs specifically. To the extent that new
precautionary statements are needed on labels due to reclassification,
OSHA believes it has incorporated those costs into its upward
adjustment of the costs of reclassification and will not double count
those costs by also increasing its estimate of costs for updating
precautionary statements and other mandatory language. Thus, for this
final analysis of the incremental compliance costs associated with the
mandatory appendices, OSHA applied the unit labor time and baseline
compliance assumptions from the PEA, and, combined with fully-loaded
2022 wage rates, generated final cost estimates, by NAICS category. As
noted earlier, these estimated costs are in addition to the costs that
are already incurred to comply with applicable requirements of the
existing HCS.
NACD questioned OSHA's preliminary time allocation to the employer
class sizes (small, medium and large companies) in the estimation of
costs. NACD cited an estimate for a member company that has ``10,000
SDSs to review to meet the new standard and 4,000 to update. Even at
OSHA's .7 hours per SDS, that is 16 months of dedicated work''
(Document ID 0329, p. 11). Additionally, they stated that ``OSHA's
estimates are only somewhat realistic if a company has in-house SDS
authoring software and has maintained formulas and data used in
classification. If updated formulas or other data need to be obtained .
. . these documents will take significantly longer to update.''
Alternatively, they noted that if
companies use a vendor, they will likely be charged between $400 and
$800 for the production of an SDS and label for a single product
(Document ID 0329, p. 11).
To the extent that NACD is concerned that some chemical
distributors may need additional time to comply, either with additional
in-house staff or with contractors, OSHA has updated the final rule to
provide for eighteen to thirty-six months (depending on the nature of
the chemical compound) following publication of the rule for chemical
distributors to implement compliance with all modified provisions. To
the extent that NACD is arguing that OSHA has underestimated the in-
house labor costs for updating SDSs and labels, they have only argued
that OSHA has possibly underestimated for a subset of companies and has
not provided data on how OSHA could differentiate which companies this
would be true for or how significant they think OSHA's underestimates
are, so OSHA is unable to evaluate this claim. And finally, to the
extent that NACD is arguing that the vendor prices will result in
higher costs than the agency estimates, as OSHA has previously stated
it believes that updates are going to be folded into the normal cycle
of updates for which companies would also use these contractors so the
full cost of a contractor producing an SDS or label is not attributable
to the HCS updates as NACD suggests.
Table VI-14 shows the estimated costs associated with modifications
to electronic templates for SDSs and labels to conform to formatting
and language criteria in precautionary statements and other mandatory
language specified in the revisions to Appendices C and D by NAICS
industry and establishment size. The NAICS industries listed in Columns
1 and 2 of Table VI-14 are those that OSHA expects will need to update
SDSs and labels under the revisions to Appendices C and D. The
industries included are the ones OSHA identified as incurring costs for
SDSs in the FEA in support of OSHA's 2012 HCS final rule (77 FR 17644-
17650). The estimated costs associated with the revisions to the
appendices are directly related to the number of SDSs (or, in other
words, the number of electronic templates) affected. These numbers were
previously derived and presented in Tables VI-5, VI-6, and VI-7.
The estimates of total costs in Table VI-14 are included within a
broader cost category shown earlier in the aggregate costs presented in
Table VI-12. Column 5 of Table VI-12 displays, by NAICS code, the
combined annualized cost estimates for reclassifying chemicals (from
Table VI-13) and revising SDSs and labels to be consistent with the
precautionary statements and other language specified in the revisions
to the mandatory appendices (from Table VI-14).
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VI. Management Familiarization and Other Management-Related Costs
In order to implement the new requirements in the HCS or determine
whether they need to implement any of the revisions to the standard,
all employers currently covered by the standard will need to become
familiar with the updates OSHA is making in this final rule. The nature
and extent of the familiarization required will vary depending on the
employer's business.
In the 2012 HCS final rule (77 FR 17637-17638), OSHA estimated that
eight hours of time per manager, or an equivalent cost, would be
associated with the necessary familiarization and implementation of
revisions to hazard communication programs in affected establishments
in the manufacturing sector.\37\ This final rule requires some changes
to hazard communication programs in affected establishments, but those
changes are significantly less extensive than those required by the
2012 rule. Therefore, OSHA believes that much less time will be needed
for familiarization and implementation under this rule than was
necessary under the 2012 rule.
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\37\ Larger employers were estimated to have greater
familiarization costs for the 2012 HCS final rule because they have
more managers.
---------------------------------------------------------------------------
For the present rule, OSHA in the PEA estimated that management
familiarization time would vary by establishment size and would also
vary depending on whether an establishment would simply be
familiarizing itself with the revised standard or would also need to
take further action because it would be affected by one or more of the
revisions to the standard. Above in Section VI.C, Profile of Affected
Industries, Establishments, and Employees, Table VI-10 presents, by
NAICS industry, the percentage of establishments (and for training,
entities) expected to be affected by rule familiarization and whether
those establishments or entities will incur additional costs or no
additional costs--that is, whether those establishments or entities
will incur additional costs for revising SDSs/labels or for training
employees as a result of the final rule.\38\ In terms of manufacturing
establishments that would have costs in addition to management
familiarization costs, OSHA in the PEA estimated that there are 38,018
small establishments (those with fewer than 20 employees), 11,273
medium establishments (those with 20 to 499 employees), and 394 large
establishments (those with 500 or more employees). In terms of
establishments that would not have costs other than management
familiarization costs, OSHA estimated in the PEA that there are 79,500
small establishments, 22,657 medium establishments, and 467 large
establishments; their only costs associated with this final standard
would be as a result of rule familiarization.\39\
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\38\ Wholesalers in NAICS 424910 and NAICS 424950 are not
expected to incur costs for revising SDSs/labels or for training
employees, but OSHA expects that they will be affected by the
provisions of the proposed rule that are anticipated to result in
cost savings.
\39\ Note that the numbers of small, medium, and large
establishments reported above are derived in the ``Rule Fam'' tab of
the OSHA spreadsheets in support of this proposed rule (see Document
ID 0049).
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To estimate unit costs, OSHA in the PEA first considered
establishments that would incur costs, in addition to rule
familiarization costs, because of the proposed rule. As noted earlier,
for the 2012 FEA OSHA applied a Manager hourly wage to estimate
familiarization costs (Document ID 0005, Section VI, pp. 17612-17613,
17623; Document ID 0029). For the PEA, because the new requirements are
significantly less extensive than those in the 2012 rule, OSHA expected
that the employer will delegate to a Health and Safety Specialist the
responsibility for management familiarization of the new requirements
found within this proposed standard. OSHA invited public comment on the
agency's preliminary assumptions for estimating the cost of management
familiarization. As discussed above in the section on the revised
hazard classification provisions, commenters tended to focus on the
overall effect of the proposed standard on labor efforts required to
update SDS software and labels. For example, in response to a request
for comment on costs for management familiarization in relation to the
proposed rule, Ameren stated that it did not agree with OSHA's
assumptions on the cost of management familiarization but based that
statement on the time required to train all of the employees, which is
a separate cost that OSHA accounts for (Document ID 0309, p. 8).
CISC, however, disagreed with OSHA's preliminary assessment of the
unit time burden for management familiarization and specifically noted
that the estimate of 4 hours, 1 hour, and .25 hours for large, medium,
and small establishments that are not chemical manufacturers
respectively were too low and particularly for small entities who were
unlikely to employ a safety and health specialist and therefore would
need more time for familiarization (Document ID 0335, p. 2).
In estimating costs for establishments that would incur costs in
addition to rule familiarization costs, for small establishments OSHA
preliminarily estimated management familiarization costs of 0.5 hours
of a Health and Safety Specialist's labor time. For medium
establishments, OSHA in the PEA estimated two hours of a Health and
Safety Specialist's labor time. For large establishments, OSHA
estimated eight hours of a Health and Safety Specialist's labor time
for the purpose of estimating costs of management familiarization.
Multiplying these labor burdens by the loaded hourly wage of $58.00
resulted in preliminary management familiarization costs per
establishment of $29.00, $116.01, and $464.04 for small, medium, and
large establishments, respectively.
For this FEA, based on the evidence submitted by commenters
regarding the complexity of some of the updates, as well as the need
for managers to understand the substantive revisions to the Appendices,
OSHA believes that it would be appropriate to double the preliminary
time estimates for management familiarization for employers affected by
other provisions in the revised standard. Therefore, for small
establishments, OSHA in this FEA estimates management familiarization
costs of one hour of a Health and Safety Specialist's labor time. For
medium establishments, OSHA in this FEA estimates four hours of a
Health and Safety Specialist's labor time. For large establishments,
OSHA estimates 16 hours of a Health and Safety Specialist's labor time
for the purpose of estimating costs of management familiarization.
Multiplying these labor burdens by the loaded hourly wage of $61.18
results in final management familiarization costs per establishment of
$61.18, $244.73, and $978.92 for small, medium, and large
establishments, respectively.
For establishments that would not incur other costs as a result of
the proposed rule (below, these employers are termed ``indirectly
affected establishments''), OSHA in the PEA estimated that rule
familiarization will take half as long as the time estimated in the PEA
for establishments that would incur other costs under the proposed
rule. In those cases, management will not need to devote as much time
to considering (or making compliance decisions about) the provisions in
the proposed rule that are expected to result in costs, and they would
primarily need to familiarize themselves with the rule only to the
extent of understanding that they did not fall within the scope of the
changes being made. Therefore, OSHA adopted
estimates of 0.25 hours, 1 hour, and 4 hours of a Health and Safety
Specialist's labor time for small, medium, and large establishments,
respectively. CISC's comment on the estimate of hours required for
indirectly affected establishments did not provide evidence to support
the argument that OSHA's understanding of these management
familiarization costs was incorrect because they did not provide
information about how many small entities might not employ a Safety and
Health Specialist, what person other than a Health and Safety
Specialist would perform the work, or how long it would take them, nor
did they explain how downstream users would be more directly impacted
by any of the proposed changes, so OSHA has left unchanged the
preliminary per-establishment labor burden estimates for indirectly
affected establishments. Multiplying the labor burdens by the loaded
hourly wage of $61.18 results in management familiarization costs per
establishment of $15.30 for small establishments, $61.18 for medium
establishments, and $244.73 for large establishments.
These management familiarization costs per establishment are
multiplied by the relevant number of small, medium, and large
establishments, resulting in an estimated undiscounted one-time
familiarization cost of $8.0 million. Annualizing this one-time cost
using a seven percent discount rate over a 10-year period results in an
estimate of annualized costs of $1.1 million. Table VI-15 presents the
detailed unit values factoring into OSHA's estimate of management-
related costs. The distribution of these management-familiarization
costs by NAICS code is displayed in Column 3 of Table VI-12.
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BILLING CODE 4510-26-C
VII. Costs Associated With Training Employees
In the PEA, OSHA estimated the incremental costs to train health
and safety personnel who are covered by the HCS and are already trained
in accordance with the 2012 standard but would need to receive
additional training to become familiar with the updates to SDSs and
labels for impacted aerosols, desensitized explosives, and flammable
gases. This analysis is described below.
OSHA preliminarily concluded that these would be the only training
costs associated with the revisions to the HCS. The agency requested
comments on this determination and received comments, from NACD,
indicating that they believed OSHA should include training costs for
retraining workers across all areas (Document ID 0329, p. 11).
As OSHA noted in the PEA, however, OSHA did not estimate any
training costs for users of aerosols, desensitized explosives, or
flammable gases in the workplace because the agency does not believe
that these users would need to dedicate more than a trivial amount of
time to training associated with the reclassification of these
chemicals. This is because the hazards associated with these chemicals
have not changed; the only thing that is changing under the revisions
to the HCS is the way the hazards are classified. For example, users of
pyrophoric gases should already have received training on the fire- and
explosive-related hazards associated with these chemicals, whereas
health and safety personnel who are processing the inputs to the gases
upstream or reviewing revised SDSs and labels for the first time may
need additional training to learn about the hazards. At most,
downstream users might require notification of a change in the
classification of those chemicals. Similarly, even though
``desensitized explosives'' is a new hazard classification, the
explosion hazards were and are well-known and should have been included
in prior hazard training. For example, should the water or other
wetting solution dry out, an explosion could occur. In this case, even
the hazard pictogram (flames) remains unchanged. For this final
analysis of costs for training, OSHA declines to add costs for
retraining because such additional time would double-count the costs
associated with both (1) the baseline training already assigned costs
in the 2012 FEA and (2) the incremental training estimated in this FEA.
Therefore, OSHA does not agree with NACD that it should take costs for
all the workers who are required to receive training under the HCS.
OSHA also received a comment from NAIMA indicating that ``NAIMA and
its members conduct training, but the cost would not be in more
training, but in the review of the training materials to make certain
that the different changes are captured in the training materials''
(Document ID 0461, p. 3). OSHA notes that, as indicated in Table VI-16
below, the agency has already incorporated the cost for the preparation
of training materials and has used an estimate of 2.5 hours of labor
for a safety and health specialist to develop the materials necessary
for instructing personnel on chemical hazards communicated through the
revised standard.
OSHA considered whether some increase in user training might be
required for some aerosols, since a small portion of these may not
currently be classified as either flammable aerosols or gas under
pressure; as noted in the discussion of Appendix B in Section XIV.,
Summary and Explanation of the Final Rule, such aerosol containers
differ from pressurized gas cylinders in terms of container
characteristics and failure mechanisms. Training for non-flammable
aerosols might include their revised classification and hazard
avoidance measures (such as: keep away from heat, hot surfaces, sparks,
open flames and other ignition sources; no smoking; do not pierce or
burn, even after use). However, based on observation of the industry
over time, OSHA believes that aerosols that are neither flammable nor
fall under gases under pressure are fairly uncommon and, therefore,
OSHA preliminarily concluded that the total user training time required
for non-flammable aerosols not under pressure would also be negligible.
As discussed above, under the final rule, some health and safety
personnel who are covered by, and are already trained in accordance
with, the existing standard will need to receive additional training to
become familiar with the updates to SDSs and labels for impacted
aerosols, desensitized explosives, and flammable gases. OSHA expects
that the incremental training costs for these employees to become
familiar with the revisions to the HCS will be small. In certain cases,
affected employers will be able to integrate the necessary training
into existing training programs and related methods of distributing
safety and health information to employees; those employers would not
incur any meaningful additional costs.
In the PEA, OSHA estimated that each affected chemical
manufacturing firm \40\ would need to devote 2.5 hours of a Health and
Safety Specialist's time to preparing new training under the proposed
rule, and that each affected logistics or production worker would spend
12 minutes receiving the training. Multiplying these unit time
estimates by the respective hourly wage and by the number of affected
firms (2,754), the number of affected logistics managers (1,179), and
the number of affected production workers (76,447) yielded a
preliminary undiscounted one-time cost of $843,940. Annualizing this
one-time cost using a seven percent discount rate over a 10-year period
resulted in estimated annualized costs of $120,158.
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\40\ OSHA anticipates that, in practice, training would be
organized more efficiently at the corporate (firm) level than at the
establishment level.
---------------------------------------------------------------------------
OSHA invited interested parties to provide comments on the
preliminary total cost estimates and the assumptions underlying them.
Specifically, the agency requested comments on its preliminary
conclusions regarding training time for users of reclassified
chemicals.
Ameren described the scope of their organization's current GHS
training program and outlined the impact of the proposed training
requirements in OSHA's 2021 NPRM. They estimated that for their
corporation, which has 9,231 employees, the total spent on training
would be approximately $3,000,000 and it would take one year to update
all of their training materials. This estimate was based on an
assumption that they would need to retrain all of their employees,
including on the combustible dust provisions and the labels on small
containers (Document ID 0309, p. 4).
As discussed above, however, OSHA has concluded that the training
times necessary for informing workers will be trivial because they will
not need to be trained on fundamental changes to hazards. The
information Ameren provided only indicated that they thought they
needed to train all of their workers on all of the changes but did not
provide estimates of how much time each worker would need to spend on
receiving such training under their assumptions, and therefore their
comment is difficult to compare with OSHA's assumption that only a
trivial amount of time will be spent on training based on these updates
for users of chemicals. Similarly, NAIMA briefly commented on the
compliance burden imposed by the proposed training requirements,
stating workers would need to be trained on the new hazard class and
hazard categories and that OSHA needed to account for these costs
(Document ID 0338, p. 4). In response, OSHA notes that this FEA
accounts for the incremental compliance burden imposed by the proposed
training requirements and that NAIMA did not elaborate further on the
costs of employee training, nor did the association provide any
quantitative details on the expected cost burden that would allow
comparison with the estimates in the PEA.
Therefore, because stakeholders in this rulemaking provided few if
any details on specific changes in OSHA's preliminary estimate of
incremental training costs necessary to align with employer
expectations of changes to training programs, and because these
expectations are based on an incorrect assumption about the amount of
training required, the agency has no basis in the record to depart from
its preliminary estimate of incremental training costs and believes
that it adequately reflects the real-world changes among affected
employers.
Multiplying the labor burden for each labor category by the loaded
hourly wages of $61.18 for a Health and Safety Specialist, $60.37 for
logistics personnel, and $31.09 for production workers, results in unit
costs of $152.96, $12.07, and $6.22, respectively.
As shown in Table VI-16, expressed in 2022 dollars, the incremental
one-time undiscounted final training costs are expected to total $0.96
million and, annualized over ten years, incremental final training
costs are expected to total $136,953 at a 7 percent discount rate. The
unit values that factored into OSHA's estimate of training costs are
shown in Table VI-16.\41\ The distribution of these training costs by
NAICS code is displayed in Column 4 of Table VI-12.
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\41\ The estimated number of affected firms, logistics managers
and production workers are derived in Document ID 0481, tab
``Training''. The affected number of firms (3,469) can also be
calculated by matching the NAICS codes with training costs from
Table VI-12 with the number of affected firms in the identical NAICS
codes in Table VI-1 and multiplying by 50 percent (only 50 percent
are estimated to require training).
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VIII. Cost Savings Associated With the New Released for Shipment
Provisions
In paragraph (f)(11) of the 2012 HCS, chemical manufacturers,
importers, distributors, or employers who become newly aware of any
significant information regarding the hazards of a chemical must revise
the labels for the chemical within six months of becoming aware of the
new information and ensure that labels on containers of hazardous
chemicals shipped thereafter contain the new information. In the NPRM,
OSHA proposed to modify paragraph (f)(11) such that chemicals that have
been released for shipment and are awaiting future distribution need
not be relabeled; however, if the manufacturer or importer opts not to
relabel the chemicals they must provide an updated label for each
individual container with each shipment. Relatedly, OSHA also proposed
in the NPRM to add new paragraph (f)(1)(vii) to require the inclusion
of a released for shipment date on labels on shipped containers.
OSHA anticipated that these proposed modifications to paragraph
(f)(11) would provide cost savings to manufacturers and distributors of
certain products--those with large (and typically infrequent)
production runs and lengthy shelf lives (often five years or longer)
that, during production, are labeled, boxed, palletized, and shipped,
and then go through the distribution chain usually without the chemical
contents, packaging, or label being disturbed. OSHA invited public
comment on the agency's preliminary determination that the proposed
modifications to paragraph (f)(11) would generate cost savings and on
its preliminary analysis of the factors that would contribute to the
cost savings. Specifically, in its preliminary determination of
technological feasibility, OSHA invited public comment ``on any
employer concerns associated with . . . the proposed provision
addressing the relabeling of containers that have been released for
shipment.
In the PEA, OSHA identified six industries (four manufacturing and
two wholesale) that it expected would be impacted by the proposed
modifications to paragraph (f)(11).\42\ These are primarily fertilizer
manufacturers, paint manufacturers, and wholesalers of related farm and
paint supplies. OSHA invited comments on whether other industries are
potentially affected by this proposed modification to paragraph (f)(11)
and whether there might be other health or economic effects of this
proposed modification that OSHA had not considered in its proposal.
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\42\ In principle, pesticide manufacturers would also be
affected by the revision to the standard, but pesticide labeling in
the United States is covered by the U.S. EPA under FIFRA (7 U.S.C.
136 et seq.). For that reason, any cost savings due to OSHA's
proposed revisions to paragraph (f)(11) would not apply to
manufacturers in NAICS 325320: Pesticide and other agricultural
chemical manufacturing.
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The Society of Chemical Manufacturers & Affiliates (SOCMA)
supported proposed (f)(11) and noted that ``SOCMA . . . believes it
will significantly reduce the compliance burdens for chemicals that
have been released for distribution'' (Document ID 0447, p. 3).
Ameren commented that it ``would incur an additional cost for
having to re-print and replace current labels based on the new OSHA
changes. The cost is estimated at $5 Million and would take over two
years to complete'' (Document ID 0309, p. 6). The National Propane Gas
Association (NPGA) also addressed the cost associated with the addition
of a released for shipment date. They indicated that there are at least
40 million propane gas cylinders that are up to 20 pounds and another
10 million tanks and cylinders that range from 33.5 to 420 pounds. They
estimated that the cost of updating all the labels to add a released
for shipment date would be about $55 million, with a $1 cost per label
for the smaller size tanks and a cost of $1.50 per label for the larger
tanks (Document ID 0440, pp. 1-2). Carbide Industries LLC also
indicated concerns with the requirement to add a release for shipment
date and noted that ``the additional cost to chemical manufacturers,
importers, or distributors of implementing and complying with [the]
proposed requirement will be significant in many cases (Document ID
0290, p. 1). Industrial Minerals Association--North America (IMA-NA)
stated their belief that ``[t]his exemption, while well-meaning will
not alleviate any burden to manufacturers'' because of the released for
shipment date requirement'' (Document ID 0363, pp. 7-8).
In response to these and other comments discussed in the discussion
of paragraph (f) in Section XIV., Summary and Explanation of the Final
Rule, OSHA has removed the proposal to include a released for shipment
date,
and therefore the costs that these commenters highlight for needing to
update all labels to include the release for shipment date will not be
incurred.
Commenters also expressed concerns about the costs of this
provision that indicated they did not understand the provision is
optional. ACI argued that ``Complying with these proposed requirements
could slow the release of products, needlessly complicate the timing of
shipments, and cause confusion on labels with a process that has an
unclear safety outcome. These requirements could also cascade down to
the storage and distribution chain causing logistical burdens and
additional labor costs'' (Document ID 0319, p. 2). NACD stated that the
impacts of the proposed requirement to send printed labels with each
shipment ``would be prohibitively expensive'' and that tracking
shipments on label status is ``not feasible.'' NACD further stated that
``[e]xtensive new programming and software would be needed to handle
this'' (Document ID 0465, p. 3).
The language that was proposed and is being finalized in paragraph
(f)(11) only creates a new option for companies to comply with the HCS.
If they want to, they can choose not to relabel chemicals that have
been released for shipment, in which case they would have to provide an
updated label with the shipment (although the label no longer includes
the proposed requirement for the release for shipment date). OSHA
believes that this revision to the proposed regulatory text addresses
comments about the feasibility of this provision. However, if the
company believes that choosing to not relabel their chemicals before
shipment would, as ACI indicated, slow the release of products or
create additional labor costs, or would be prohibitively expensive, as
NACD suggested, then they can simply choose to relabel the chemicals
before they are shipped, as is already allowed by the standard. OSHA
believes that these companies are rational actors who will choose to
relabel their shipments if choosing the option to not relabel would be
more expensive. Regardless of whether the company chooses to relabel or
not, they would need to create an updated label, just as they do under
the 2012 HCS, so the creation of the label itself is not a new cost.
Therefore, OSHA is not accounting for additional costs when these
companies have the option to continue complying with the HCS as they
have and therefore will not face an increase in compliance costs above
their current baseline.
For the PEA, the first factor used to estimate the cost savings
resulting from the proposed changes to paragraph (f)(11) was the
avoided economic loss for affected manufacturers or wholesalers who
would otherwise have to relabel products being held in storage. To
estimate the potential economic loss avoided, OSHA relied on comments
submitted to the agency by the Council of Producers & Distributors of
Agrotechnology (CPDA) on April 21, 2017 (Document ID 0006). The CPDA
comments included a summary of cost estimates associated with
relabeling non-pesticide agricultural chemical products in
distribution. Those estimates were obtained from an industry survey and
were based on the following unit costs: shipping costs to move product
out of and back into the warehouse (for off-site package opening and
replacement); relabeling space per square foot per month; safety
equipment and training per employee involved in relabeling; labor and
materials to break down pallets and shrink-wrap and redo product
packaging in new plastic bags; and labor and materials to move liquid
to new containers and dispose of old containers (Document ID 0006, pp.
4-6).
For OSHA's purposes, the critical costing information from CPDA was
the estimate of summary relabeling costs presented as a percentage of
the value of the products requiring relabeling. According to the CPDA
survey results, these summary costs range from 1.5 percent to 204
percent of the value of the product, depending on product type (e.g.,
liquid versus dry), container type (plastic bags, etc.), and the volume
and value of the product (Document ID 0006, p. 8). As a practical
matter, OSHA expects that manufacturers and wholesalers would simply
discard a product rather than incur relabeling costs in excess of the
value of the product. Of course, there may be some disposal costs for
the discarded material, but there may also be some salvage value for
the improperly-labeled product. If one assumes that the disposal cost
and the salvage value are relatively minor and, on net, offset each
other, then the upper limit on the relabeling costs for any product
would be approximately 100 percent of the value of the product. With an
effective range of labeling costs from 1.5 percent to 100 percent of
the value of the product, OSHA estimated, without further information
on the distribution of the costs, that the average labeling cost would
be approximately 50 percent of the value of the products requiring
relabeling. While this cost estimate as a percentage of the value of
the product was developed from data on relabeling non-pesticide
agricultural chemical products in distribution, OSHA assumed that this
same estimate would also apply to relabeling paints and related
chemical products in distribution.
The agency invited comments on this assumption. No commenters
addressed specifically the estimate of 50 percent of product value as a
measure of cost savings. As discussed above, several commenters broadly
criticized OSHA's preliminary analysis of costs for paragraph (f)(11)
for omitting substantial administrative and handling expenses but did
not provide specific data with which OSHA could evaluate these
purported costs. Based on professional judgment in evaluating these
comments, OSHA is not convinced that it has underestimated costs
associated with the provision and has decided to leave unchanged the
preliminary product-value cost savings of 50 percent for the final cost
analysis of paragraph (f)(11). The agency anticipates that the above
clarification of the intent of paragraph (f)(11) along with the
discussion on (f)(11) in Section XIV., Summary and Explanation of the
Final Rule, will address any misconceptions concerning additional
compliance burden imposed by final paragraph (f)(11).
The 50 percent average cost savings estimate would apply only to
those products that previously required relabeling and are likely to
take advantage of this option under (f)(11). In order to estimate the
expected cost savings for all products in the NAICS codes affected by
the revisions to paragraph (f)(11), OSHA also needed to estimate three
other factors (in addition to the average cost savings of 50 percent):
(1) what percentage of the products in these NAICS industries would be
warehoused for more than six months; (2) what percentage of products
warehoused for more than six months would, under the 2012 HCS, be
relabeled in any particular year due to a manufacturer becoming newly
aware of significant information regarding the hazards of the product;
and (3) the percentage of all products in the NAICS industries that are
covered by the HCS.
OSHA was unable to identify data relevant to factors (1) and (2)
above and instead worked with its contractor, ERG, to develop estimates
of both of these factors. For (1) above, OSHA expected that the
percentage of products warehoused for more than six months would be
quite low because it is expensive to hold inventory over long periods
of time. Therefore, OSHA estimated that just 5 percent of the products
in the six NAICS industries potentially impacted by the proposed
modifications to paragraph (f)(11) would be warehoused for more than
six
months. For (2) above, OSHA anticipated that manufacturer-initiated
relabeling would be rare and estimated that only 1 percent of products
warehoused for more than six months would be relabeled in any
particular year due to a manufacturer-initiated labeling change. OSHA
invited comments on the preliminary estimates described above and
received no comments specifically on the estimates.
For factor (3) above, OSHA assumed that 100 percent of the products
in the four NAICS manufacturing industries are covered by the HCS.\43\
For the two wholesale industries, however, a substantial portion of the
covered products do not qualify as hazardous chemicals covered by the
HCS or are not subject to the HCS labeling requirements. For NAICS
424910: Farm Supplies Merchant Wholesalers, a significant majority of
the wholesale supplies are non-fertilizers, such as grains (e.g.,
alfalfa, hay, livestock feeds) and nursery stock (e.g., plant seeds and
plant bulbs) that are not subject to the HCS. Based on data from the
2012 Economic Census,\44\ ERG estimated that 41.7 percent of the
wholesale supplies in NAICS 424910 would be fertilizers affected by the
proposed released-for-shipment provision (Document ID 0049, tab ``RF
Shipment''). For NAICS 424950: Paint, Varnish, and Supplies Merchant
Wholesalers, some proportion of the wholesale supply consists of non-
paints and non-chemicals, such as wallpaper and painting supplies such
as paintbrushes, rollers, and spray-painting equipment. Based on data
from the 2012 Economic Census, ERG estimated that 77.6 percent of the
wholesale supplies in NAICS 424950 would be paints and related
chemicals affected by the proposed released-for-shipment provision
(Document ID 0049, tab ``Variables''). OSHA used ERG's estimates to
develop the expected cost savings attributable to the proposed
revisions to paragraph (f)(11). The agency invited comments on the
preliminary estimates of factor (3) in the cost model and received no
comments specifically on the estimates.\45\
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\43\ A review of the products covered under the manufacturing
NAICS codes reveals they are all, or almost all, chemicals.
\44\ 2012 Economic Census of the United States, Table
EC1242SLLS1--Wholesale Trade: Subject Series--Product Lines: Product
Lines Statistics by Industry for the U.S. and States: 2012 (Document
ID 0043).
\45\ Under the revisions to paragraph (f)(11), when relabeling
is not required for chemicals that have been released for shipment,
the chemical manufacturer or importer would still be required to
provide an updated label for each individual container with each
shipment. However, the manufacturer and importer already had to
provide an updated label under the 2012 HCS, so this is not a new
cost.
---------------------------------------------------------------------------
For this FEA, OSHA updated factor (3) to reflect the affected
product line sales data (as a percentage of total sales) reported in
the 2017 Economic Census for the two affected NAICS industries in the
wholesale sector. OSHA estimated that 37.1 percent of the wholesale
supplies in NAICS 424910 would be fertilizers affected by the released-
for-shipment provision. For NAICS 424950, OSHA estimated that 82.0
percent of the wholesale supplies would be paints and related chemicals
affected by the released-for-shipment provision.\46\
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\46\ 2017 Economic Census for Wholesale Trade: All Sectors:
Industry by Products for the U.S. and States. (Series
EC1700NAPCSINDPRD) Release Date: December 16, 2021. (Document ID
0479). According to the census data for wholesale trade, OSHA
derived an estimate of 37.1 percent of wholesale agricultural
chemicals and fertilizers that are affected by the released-for-
shipment provision for NAICS 424910 Farm Supplies Merchant
Wholesalers--derived as product line sales as a percentage of total
sales of all establishments for North American Product Code System
code 4004550015 Other agricultural chemicals and fertilizers. For
NAICS 424950 Paint, Varnish, and Supplies Merchant Wholesalers,
based on the wholesale trade census data, OSHA estimated that 82.0
percent of wholesale paints and related chemicals are affected by
the released-for-shipment provision (merchant wholesalers product
line sales as a percentage of total sales of all establishments for
NAPCS products codes 4004875003 Architectural coatings, enamels,
primers, stains, solvents, and lacquers; 4004875006 Industrial/
Original Equipment Manufacturer (OEM) coatings; and 4005485012
Special purpose coatings, including automotive, refinish, marine,
and traffic coatings). (Document ID 0481, tab ``Variables'')
---------------------------------------------------------------------------
Column 3 of Table VI-18 shows the average product value (revenue)
for each of the six NAICS industries that OSHA expects will be affected
by the modification to paragraph (f)(11).\47\ And Column 4 of Table VI-
18 shows the number of affected firms (entities) for each of these six
NAICS industries.\48\ Column 5 of Table VI-18 shows the estimated loss
avoided due to the released-for-shipment provision for each of these
six NAICS industries as a percentage of that industry's revenues. That
percentage is the product of the four factors estimated above: (1) the
costs of relabeling as a percentage of the value of the products
requiring relabeling; (2) the percentage of the products in these NAICS
industries that will be warehoused for more than six months; (3) the
percentage of products warehoused for more than six months that would
have required generation of a new label in any particular year due to a
manufacturer-initiated labeling change; and (4) the percentage of all
products in the NAICS industries covered by the HCS.
---------------------------------------------------------------------------
\47\ Derived for each NAICS by dividing Column 3 of Table VI-9
(total industry revenues) by Column 7 of Table VI-1 (number of
affected firms).
\48\ Obtained from Column 7 of Table VI-1.
---------------------------------------------------------------------------
Table VI-17 presents, by NAICS industry, these four factors and the
calculated percentage loss in revenue OSHA anticipates will be avoided
under the revised released-for-shipment provision.
[GRAPHIC] [TIFF OMITTED] TR20MY24.188
The estimated cost savings for each of the six affected industries
arising from the modifications to paragraph (f)(11) then is simply the
product of Columns 3, 4, and 5 in Table VI-18. Summing the cost savings
for each of the six industries yields an estimated annual cost savings
of $33.3 million.
[GRAPHIC] [TIFF OMITTED] TR20MY24.189
In the PEA OSHA requested comments on the reasonableness of the
agency's preliminary cost estimate for the proposed revision to
paragraph (f)(11) and the assumptions underlying it (including the
various factor percentage estimates listed in Table VI-17). Ameren
agreed that there are ``potential cost savings'' resulting from the
revision to (f)(11) (Document ID 0309, p. 11) and SOCMA agreed that
this would ``reduce the compliance burdens'' (Document ID 0447, p. 3);
no other commenters addressed this issue.
Therefore, OSHA's estimate of cost savings shown in Table VI-18
reflects, in the agency's view, a reasonable determination of the
impacts of final paragraph (f)(11).
Cost Savings Associated With the New Provisions for Labels on Very
Small Containers
Proposed new paragraph (f)(12), which addresses the labeling of
small and very small containers, limits labeling requirements for
chemical manufacturers, importers, or distributors where they can
demonstrate that it is not feasible to use pull-out labels, fold-back
labels, or tags to provide the full label information as required by
paragraph (f)(1). As specified in paragraph (f)(12)(ii), manufacturers,
importers, and distributors would be able to use an abbreviated label
(requiring only the product identifier, pictogram(s), signal word,
chemical manufacturer's name and phone number, and a statement that the
full label information is provided on the immediate outer package) on
containers with a volume capacity of 100 ml or less--referred to as
``small containers'' in this FEA. As specified in paragraph
(f)(12)(iii), manufacturers, importers, and distributors would need to
put only the product identifier on containers with a volume capacity of
3 ml or less--referred to as ``very small containers'' in this FEA--if
they can demonstrate that any label would interfere with the normal use
of the container.
Following publication of the 2012 updates to the HCS, stakeholders
requested that OSHA clarify its enforcement policy on labels for small
containers. In response, through letters of interpretation, OSHA
adopted practical accommodations that specified: (1) the minimum
information required for a label on the immediate container of the
shipped chemical; and (2) the minimum information required
for the outer packaging of shipped small containers (see, e.g.,
Document ID 0170; 0174; 0200). Paragraph (f)(12)(ii) in this final rule
incorporates the accommodations for small containers described in these
letters of interpretation. However, the letters of interpretation did
not contain any guidance unique to very small containers, which are now
covered by paragraph (f)(12)(iii).
For costing purposes, OSHA in the PEA estimated that no cost
savings will arise from proposed paragraph (f)(12)(ii) (small
containers); OSHA expected that employers are already benefitting from
the practical accommodations on the labeling of small packages
described in the aforementioned letters of interpretation. OSHA invited
public comments on that preliminary determination and the magnitude of
any cost savings that should be attributed to proposed paragraph
(f)(12)(ii). OSHA received no comments on either of the two questions
pertaining to the agency's preliminary determination of current
practical benefits and zero cost savings associated with paragraph
(f)(12)(ii).
In the PEA, OSHA estimated cost savings under proposed paragraph
(f)(12)(iii) for manufacturers, importers, and distributors of very
small containers (volume capacity of 3 ml or less) where the use of any
label (even an abbreviated label as specified in proposed paragraph
(f)(12)(ii)) would interfere with the normal use of the container and
only the product identifier would be required. OSHA preliminarily
determined that affected manufacturers would fall in only a few NAICS
industries: Other Basic Chemical Manufacturing, Inorganic and Organic
(NAICS 325180 and 325199, respectively) and Pharmaceutical and Medical
Manufacturing (NAICS 3254--encompassing 6-digit NAICS 325411, 325412,
325413, and 325414). As shown in Table VI-19 in the PEA, OSHA estimated
that there are approximately 63.5 million labels on very small
containers in these six 6-digit NAICS manufacturing industries that
could be affected by that part of the proposed rule.\49\
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\49\ The number of very small containers in Column 3 of Table
VI-19 for each of these six NAICS industries was obtained from
Column 4 of Table VI-5, both in the PEA and in this FEA.
---------------------------------------------------------------------------
Even in these six NAICS industries, however, OSHA in the PEA
expected that manufacturers would not be able to take advantage of
proposed paragraph (f)(12)(iii) in all cases because that provision
applies only when the manufacturer, importer, or distributor can
demonstrate that it is not feasible to use pull-out labels, fold-back
labels, or tags containing the full label information and that even an
abbreviated label would interfere with the normal use of the container.
Of the 63.5 million potentially affected labels on very small
containers, OSHA estimated in the PEA that for only 40 percent of them,
or for an estimated total of 25.4 million very small containers, would
manufacturers fall under proposed paragraph (f)(12)(iii) (see Column 5
of Table VI-19 and, equivalently, Column 7 of Table VI-5 in the PEA).
Manufacturers with containers falling under paragraph (f)(12)(iii)
could expect to obtain cost savings from avoided labeling costs on very
small containers (with only the product identifier required) versus the
labeling costs of abbreviated labels (requiring the product identifier,
pictogram(s), signal word, manufacturer's name and phone number, and a
statement that the full label information is provided on the immediate
outer packaging). In the PEA, OSHA estimated an incremental unit cost
savings of $0.051 per label for very small containers.\50\ That unit
cost savings was expected to be net of the cost of providing a full
label on the immediate outer package (containing a set of very small
containers) per paragraph (f)(12)(iv)(A). OSHA requested public comment
on the agency's preliminary estimate ($0.051) of unit cost savings for
paragraph (f)(12)(iii). OSHA did not receive any comments objecting to
the preliminary estimate of unit cost savings; therefore, updating the
preliminary estimate to 2022 dollars, the agency estimates unit cost
savings of $0.058 per label for paragraph (f)(12)(iii).
---------------------------------------------------------------------------
\50\ The Flavor and Extract Manufacturers Association of the
United States provided to OSHA (in a letter dated April 27, 2018)
(Document ID 0257) a summary of survey results obtained from member
companies concerning how they might benefit from relaxed OSHA
labeling requirements on small containers. Those results included an
estimate of $0.85 per label for small capacity containers compliant
with the 2012 HCS. However, this estimate applies to expensive
labels--such as pull-out labels, fold-back labels, and full-
information tags--and therefore is not applicable to the cost
savings associated with using only the product identifier in lieu of
the abbreviated labeling specified in proposed paragraph
(f)(12)(ii). In the PEA, OSHA stated that it is likely that most of
the cost savings reported from the Flavor and Extract Manufacturers
Association survey would be attributable to the expensive types of
labels. Based on the unit cost data provided by the Flavor and
Extract Manufacturers Association, OSHA estimated a unit cost
savings of $0.05 in 2018 dollars for the use of labels with the
minimum information--the product identifier--required for very small
containers (versus abbreviated labels). Updating the 2018 estimate
to 2019 dollars using the BEA (2020) implicit price deflator for
Gross Domestic Product, OSHA in the PEA derived an estimate of
$0.05087 (or rounding, $0.051) in cost savings per label (with the
unrounded estimate used in the analysis).
---------------------------------------------------------------------------
As shown in Table VI-19, multiplying the number of affected labels
by the unit cost savings of $0.058 per label for very small containers
yields estimated annual cost savings of $1.7 million.
[GRAPHIC] [TIFF OMITTED] TR20MY24.190
In the PEA, OSHA invited interested parties to provide comments on
the preliminary cost estimates for the proposed paragraph (f)(12) and
the assumptions underlying them. Elsewhere in the NPRM, the agency
requested comments on the feasibility of, and any cost savings
associated with, the proposed provisions for the labeling of small and
very small containers and whether the proposed labeling requirements
would be adequate to provide for safe handling and storage of chemicals
in small containers. Ameren noted the costs of needing to re-print and
replace current labels but stated, ``experience [within Ameren]
indicates there is potential cost savings associated with the proposed
provisions for the labeling of small containers (both 100 ml and 3 ml
and less). . . . Ameren agrees that the proposed labeling requirements
would be adequate to provide for safe handling and storage of chemicals
in small containers'' (Document ID 0309, p. 12). OSHA infers from
Ameren's comment and the absence of any opposing comments that the
proposed labeling requirement (paragraph (f)(12)) for small containers
could, and in OSHA's estimation likely will, provide cost savings.
Therefore, OSHA's final estimate of cost savings for paragraph
(f)(12)(iii) is $1.7 million, as reported above and shown in Table VI-
19.
IX. Concentration Ranges
In addition to the five categories discussed above where
significant costs or cost savings are expected, OSHA received comments
on a set of provisions addressing concentration ranges in relation to
confidential business information that, in OSHA's final assessment,
will not create significant economic impacts.
IMA-NA expressed concern that compliance with paragraph (i) will
impose labeling costs that were not recognized in OSHA's economic
analysis because ``it will take considerable time and money to realign
product lines with the new ranged approach to CBI'' (Document ID 0363,
p. 6). The Vinyl Institute warned that ``a significant anti-competitive
impact on the market'' could result from too-narrow prescribed
concentration ranges (Document ID 0369, Att. 2, p. 9). ILMA also
predicted that the concentration range requirement would create market
disruptions, noting that the majority of its members who responded to
ILMA's survey indicated that overly narrow concentration ranges would
erode competitive advantage (Document ID 0460, Att. 2, p. 2). Ameren
recommended that the final rule allow combinations of concentration
ranges across all conceivable percentages because such flexibility
would potentially yield cost savings (Document ID 0309, p. 13).
In response to stakeholder concerns about the loss of competitive
advantage through the reverse engineering of confidential information
on chemical concentration ranges, OSHA's final set of requirements in
paragraph (i) prescribe reasonably narrow concentration ranges that may
be used in combination to preserve trade secrets. OSHA believes that
final paragraph (i) strikes a responsible balance between averting
significant economic impacts among affected employers and the
disclosure of sufficient information on the chemical properties of
commercial products to communicate workplace hazards. And because
stakeholders provide no evidence demonstrating that loss of CBI and
trade secrets were likely outcomes under any scenarios that incorporate
OSHA's final set of requirements in paragraph (i), the agency foresees
no additional significant costs. In response to comments that it will
take time to update labels to align with this provision, OSHA expects
that many companies have already created labels that align with
Canada's system and therefore will have already aligned their labels
with these ranges. IMA-NA also did not provide any suggestion of what
the costs might be in order to do such updating for companies that have
not already aligned with Canada, so OSHA does not have any basis for
incorporating an estimate of time needed for compliance. Additionally,
because it is optional for companies to claim trade secrets and
therefore to use these ranges, companies that are concerned about costs
can simply choose not to claim trade secrets and not incur costs
related to this provision.
X. Sensitivity Analysis
In this section, OSHA presents the results of a sensitivity
analysis to demonstrate how robust the estimates of net cost savings
are to changes in various cost parameters. In this analysis, OSHA made
a series of isolated changes to individual cost input parameters in
order to determine their effects on the agency's estimates of
annualized net cost savings, with a seven-percent discount rate as the
reference point. The agency has conducted these calculations for
informational purposes only.
The methodology and calculations underlying the cost estimates
associated with this rulemaking are generally linear and additive in
nature. Thus, the sensitivity of the results and conclusions of the
analysis will generally be proportional to isolated variations in a
particular input parameter. For example, if the estimated time that
employees will need to devote to attending new training doubles, the
corresponding labor costs would double as well.
OSHA evaluated a series of such changes in input parameters to test
whether and to what extent the general conclusions of this FEA held up.
OSHA considered changes to input parameters that affected only costs
and cost savings and determined that each of the sensitivity tests on
cost parameters had only a very minor effect on total costs or net
costs. On the whole, OSHA found that the conclusions of the analysis
are robust, as changes in any of the cost input parameters still show
significant net cost savings for the final rule. The results of the
individual sensitivity tests are summarized and are described in more
detail in Table VI-20.
In the first of these sensitivity tests, OSHA reduced from 1
percent to 0.5 percent its estimate of the percentage of products
warehoused for more than six months that require relabeling in any
particular year. The effect of this change would be to reduce by 50
percent the estimated cost savings associated with the revised
released-for-shipment provision. Table VI-20 shows that the estimated
net cost savings from the final rule would decline by $16.6 million
annually, from $29.8 million to $13.2 million annually, or by about 56
percent.
In a second sensitivity test, OSHA reversed the first sensitivity
test, that is, the agency increased from 1 percent to 2 percent the
percentage of products warehoused for more than six months that require
relabeling in any particular year. The effect of this change would be
to increase by 100 percent the estimated cost savings associated with
the released-for-shipment provision. Table VI-20 shows that the
estimated net cost savings from the final rule would increase by $33.3
million annually, from $29.8 million to $63.1 million annually, or by
about 112 percent.
In a third sensitivity test, OSHA reduced from 40 percent to 20
percent the percentage of very small containers that would be affected
by revised paragraph (f)(12). As shown in Table VI-20, if OSHA's
estimates of other input parameters remained unchanged, the estimated
net cost savings from the final rule would decline by $0.9 million
annually (after rounding), from $29.8 million to $29.0 million
annually, or by about three percent.
In a fourth sensitivity test, OSHA applied the same rule
familiarization costs to all firms regardless of whether they are
affected by other provisions of this final rule, i.e., OSHA did not
reduce estimated familiarization time for firms that are not affected
by other parts of the standard. The effect of this change would be to
raise compliance costs for 100,961 establishments in manufacturing and
wholesale trade; the estimated net cost savings from the final rule
would be reduced by a little under $1.2 million annually, from $29.8
million to $28.7 million annually, or by about four percent.
In a fifth sensitivity test, OSHA doubled the estimated labor hours
assigned to revising SDSs and labels due to the reclassification of
chemicals and revised mandatory language in the appendices of the HCS
(from Tables VI-13 and VI-14). The effect of this change would be to
double labor costs for the affected six-digit NAICS industries;
estimated net cost savings would be reduced by $3.9 million annually,
from $29.8 million to $26.0 million, or by about 13 percent.
In a sixth sensitivity test, OSHA excluded overhead costs from the
fully loaded hourly wage rates used throughout the PEA. Overhead costs
were not applied in the 2012 FEA and this sensitivity test provides
consistency with the treatment of overhead in the 2012 analysis. The
effect of this change would be to remove the factor of 17 percent of
base wages from the hourly costs for the four job categories used in
the cost analysis. Applying this change, the estimated net cost savings
from the final rule would increase by $0.5 million annually, or by
about two percent, resulting in a total estimate of annualized net cost
savings of $30.4 million.
Not part of this table but discussed in the Introduction and
Summary of this FEA, the agency examined the effect of lowering the
discount rate for annualizing costs from seven percent to three
percent. Lowering the discount rate to three percent would yield
annualized net cost savings of $30.7 million, approximately $908,000
more in annual cost savings than the net cost savings at a seven
percent discount rate.
XI. Regulatory Alternatives
This section discusses two regulatory alternatives to the changes
OSHA is promulgating in this final standard: (1) removing the changes
to paragraph (f)(12) regarding labeling of very small containers, which
would eliminate cost savings for manufacturers, importers, and
distributors that label such containers; and (2) removing the changes
to paragraph (f)(11) regarding labeling of containers that have been
released for shipment, which would eliminate cost savings for
manufacturers, importers, and distributors that have such containers.
In Table VI-20, each regulatory alternative is described and analyzed
relative to the final rule. Midpoint estimates are presented in all
cases. Under Regulatory Alternative (1) (elimination of changes related
to labeling of very small containers), cost impacts total $1.7 million
(5.7 percent of baseline cost savings), resulting in a reduction of
estimated annualized net cost savings to a total of $28.1 million
(after rounding). Under Regulatory Alternative (2) (elimination of
changes related to labels on packages that have been released for
shipment), cost impacts on manufacturers, distributors, and importers
total $33.3 million (112 percent of baseline cost savings), resulting
in an overall estimate of annualized net costs of $3.4 million.
In summary, these regulatory alternatives would result in a
reduction of cost savings--a significant reduction in the case of the
second alternative (resulting in positive, but modest, overall net
costs). Neither alternative, however, would alter the agency's
determination of economic feasibility for the proposed revisions to the
HCS as a whole. Nor would these alternatives result in a significant
impact on a substantial number of small entities (see Section VI.G.,
Economic Feasibility and Impacts).
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BILLING CODE 4510-26-C
G. Economic Feasibility and Impacts
This section presents OSHA's analysis of the economic impacts of
the final rule and an assessment of economic feasibility. A separate
analysis of the potential economic impacts on small entities (as
defined in accordance with SBA criteria) and on very small entities
(those with fewer than 20 employees) is presented in the following
section as part of the Final Regulatory Flexibility Screening Analysis,
conducted in accordance with the criteria laid out in the Regulatory
Flexibility Act.
A standard is economically feasible ``if it does not threaten
massive dislocation to, or imperil the existence of, [an] industry.''
Lead I, 647 F.2d at 1265 (internal citations and quotation marks
omitted). To determine whether a rule is economically feasible, OSHA
begins with two screening tests to consider minimum threshold effects
of the rule under two extreme cases: (1) a scenario in which all costs
are passed through to customers in the form of higher prices
(consistent with a price elasticity of demand of zero); and (2) a
scenario in which all costs are absorbed by the firm in the form of
reduced profits (consistent with an infinite price elasticity of
demand).
In profit-earning entities, compliance costs can generally be
expected to be absorbed through a combination of increases in prices
and reductions in profits. The extent to which the impacts of cost
increases affect prices or profits depends on the price elasticity of
demand for the products or services produced and sold by the entity.
The price elasticity of demand refers to the relationship between
changes in the price charged for a product and the resulting changes in
the demand for that product. A larger price elasticity of demand
implies that an entity or industry is less able to pass increases in
costs through to its customers in the form of a price increase and must
absorb more of the cost increase through a reduction in profits.
If the price elasticity of demand is zero, and all costs can be
passed to customers in the form of higher prices, the immediate impact
of the rule would be observed in the form of increased industry
revenues. In the absence of evidence to the contrary, OSHA generally
considers a standard to be economically feasible for an industry when
the annualized costs of compliance are less than a threshold level of
one percent of annual revenues. Common-sense considerations indicate
that potential impacts of such a small magnitude are unlikely to
eliminate an industry or significantly alter its competitive structure,
particularly since most industries have at least some ability to raise
prices to reflect increased costs and normal price variations for
products typically exceed three percent a year.\51\ Of course, OSHA
recognizes that even when costs are within this range, there could be
unusual circumstances requiring further analysis.
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\51\ OSHA, 2016, Silica FEA Chapter VI: Economic Feasibility
Analysis and Regulatory Flexibility Determination, pp. VI-20 to VI-
23, and Table VI-3 (Document ID 0045).
---------------------------------------------------------------------------
If, however, there is infinite price elasticity of demand, and all
costs are absorbed by affected firms, the immediate impact of the rule
would be observed in reduced industry profits. OSHA uses the ratio of
annualized costs to annual profits as a second check on economic
feasibility. In the absence of evidence to the contrary, OSHA generally
considers a standard to be
economically feasible for an industry when the annualized costs of
compliance are less than a threshold level of ten percent of annual
profits. This is a fairly modest threshold level, given that normal
year-to-year variations in profit rates in an industry can exceed 40
percent or more.\52\
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\52\ OSHA, 2016, Silica FEA Chapter VI: Economic Feasibility
Analysis and Regulatory Flexibility Determination, pp. VI-20 to VI-
23, and Table VI-5 (Document ID 0045).
---------------------------------------------------------------------------
In order to assess the nature and magnitude of the economic impacts
associated with compliance with the proposed rule, OSHA developed
quantitative estimates of the potential economic impact of the
requirements on each of the affected industry sectors. The estimated
costs of compliance presented in Section VI.F., Compliance Costs and
Cost Savings, of this preamble were compared with industry revenues and
profits to provide a measure of potential economic impacts. Table VI-21
presents data on revenues and profits for each affected industry sector
at the six-digit NAICS industry level, along with the corresponding
estimated annualized costs of compliance in each sector. Potential
impacts in the table are represented by the ratios of compliance costs
to revenues and compliance costs to profits.
The nature of the revisions to the HCS is such that all affected
firms will incur some costs, but only a small subset will derive the
cost savings that are monetized in this FEA (although most or all will
enjoy non-monetized benefits, e.g., in foreign trade). To examine the
economic impacts of the revisions to the standard for those affected
establishments that obtain no monetized cost savings from any of the
final changes to the HCS, OSHA estimated the ratio of compliance costs
to revenues and the ratio of compliance costs to profits using only
gross positive costs (i.e., costs exclusive of cost savings) as the
numerator in the ratio. Table VI-22 presents this part of the agency's
screening analysis.
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BILLING CODE 4510-26-C
In the case of costs incurred due to the requirements of the
revisions to the HCS, all businesses within each of the covered
industry sectors will be subject to the same requirements. Thus, to the
extent potential price increases correspond to costs associated with
achieving compliance with the revised standard, the elasticity of
demand for each entity will approach that faced by the industry as a
whole.
Furthermore, hazardous chemicals distributed in the United States
will have to be in compliance with the updated provisions, and chemical
producers and users in most advanced economies will be operating under
comparable GHS-based requirements specific to their own country or
economic union. For this reason, affected domestic establishments
should not be susceptible to a loss of domestic market share resulting
from the competition of foreign commercial entities not bound by the
requirements of the HCS or similar GHS requirements.
Given the small increases in prices potentially resulting from
compliance with the revisions to the HCS in any particular industry,
and the lack of readily available substitutes for the products and
services provided by the covered industry sectors, demand is expected
to be sufficiently inelastic in each affected industry to enable
entities to substantially offset compliance costs through minor price
increases without experiencing any significant reduction in revenues or
profits. For example, for NAICS 324191: Petroleum Lubricating Oil and
Grease Manufacturing, even if zero cost savings are obtained and gross
positive costs reach OSHA's estimated total ($1,240,097; see Table VI-
22), revenue impacts (0.0063 percent, rounded to 0.01 percent) and
profit impacts (0.092 percent, rounded to 0.1 percent) fall well below
OSHA's screening criteria associated with economic feasibility
concerns. OSHA therefore concludes that the final rule is economically
feasible. To supplement OSHA's determination of economic feasibility,
the agency conducted a final regulatory flexibility screening analysis,
discussed immediately below.
H. Final Regulatory Flexibility Screening Analysis and FRFA
Certification
The Regulatory Flexibility Act (5 U.S.C. 601-612), as amended in
1996, requires the preparation of a Final Regulatory Flexibility
Analysis (FRFA) for rules where there would be a significant economic
impact on a substantial number of small firms. Under the provisions of
the law, each such analysis shall contain:
1. A statement of the need for, and objectives of, the rule;
2. A statement of the significant issues raised by the public
comments in response to the initial regulatory flexibility analysis, a
statement of the assessment of the agency of such issues, and a
statement of any changes made in the proposed rule as a result of such
comments;
3. The response of the agency to any comments filed by the Chief
Counsel for Advocacy of the Small Business Administration in response
to the proposed rule, and a detailed statement of any change made to
the proposed rule in the final rule as a result of the comments;
4. A description of and an estimate of the number of small entities
to which the rule will apply or an explanation of why no such estimate
is available;
5. A description of the projected reporting, recordkeeping and
other compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirements and
the type of professional skills necessary for preparation of the report
or record; and
6. A description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of the applicable statutes, including a statement of
the factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each one of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.
The Regulatory Flexibility Act further states that the required
elements of the FRFA may be performed in conjunction with or as part of
any other agenda or analysis required by any other law if such other
analysis satisfies the relevant provisions (5 U.S.C. 605(a)).
As explained below, OSHA has determined that the final rule will
not have a significant economic impact on a substantial number of small
entities, and therefore a FRFA is not required by the Regulatory
Flexibility Act. Nonetheless, OSHA has prepared a voluntary Final
Regulatory Flexibility Screening Assessment (FRFSA) to assure the
regulated community that the agency has considered the impacts of the
final rule on small entities. While a full understanding of OSHA's
analysis and conclusions with respect to costs and economic impacts on
small businesses requires a reading of the complete FEA and its
supporting materials, this voluntary FRFSA will summarize the key
aspects of OSHA's analysis as they affect small businesses and includes
a description of the impact of the rule on small entities, which is not
required under the Regulatory Flexibility Act.
I. Final Regulatory Flexibility Screening Assessment
(A). Description of the impact of the rule on small entities.
To determine whether the final revisions to the HCS will have a
significant economic impact on a substantial number of small entities,
OSHA evaluated the impact of compliance costs on the revenues and
profits of small entities in affected industries. As discussed
previously, the final rule will impose costs on impacted industries for
training; for reclassification of aerosols, desensitized explosives,
and flammable gases; and for becoming familiar with the final changes
to the standard. The rule will also result in cost savings to the
extent it limits employers' duties with respect to the labeling of some
very small containers and provides more flexible relabeling
requirements for packaged chemicals released for shipment.
Although the phase-in periods for evaluation and training on the
hazards of chemical substances and mixtures under the final rule range
from eighteen months to forty-two months, as an analytical
simplification for this FEA, OSHA has estimated costs as one-time costs
that will be incurred during the first year after the rule is
promulgated. In addition, as mentioned above, there will be annual cost
savings due to the flexibilities introduced in the provision related to
the labeling of very small containers and in the released-for-shipment
provision.
Tables VI-23 and VI-24 present OSHA's screening analysis of the
impact of compliance costs and cost savings on revenues and profits of
small and very small entities. Tables VI-25 and VI-26 present OSHA's
screening analysis of impacts on revenues and profits for small and
very small entities under the scenario that zero cost savings are
realized, i.e., only positive costs are incurred by affected employers.
OSHA's screening criteria for determining whether there are significant
economic impacts on small firms assesses whether, for small entities in
any given industry, the annualized costs exceed one percent of revenues
or five percent of profits.\53\
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\53\ OSHA's screening criteria underlying the determination of
significant economic impacts were developed in accordance with
published guidelines for implementation of the Small Business
Regulatory Enforcement Fairness Act amendment to the Regulatory
Flexibility Act; E.O.s 12866, 13563, and 13771; and the Unfunded
Mandates Reform Act. For a recent example of the application of
these screening criteria, see the FEA and FRFA for the Final Rule
for Occupational Exposure to Respirable Crystalline Silica, Chapter
VI: Economic Feasibility Analysis and Regulatory Flexibility
Determination, Document ID 0045.
---------------------------------------------------------------------------
The total annualized cost savings resulting from the revisions to
the HCS for small entities and very small entities are estimated to be
approximately $25.5 million and $1.6 million, respectively (see Tables
VI-23 and VI-24). To assess the economic impact of the final rule on
small entities and very small entities, OSHA calculated the ratios of
compliance costs to profits and to revenues. These ratios are presented
for each affected industry in Tables VI-23 (small entities) and VI-24
(very small entities). Those tables show that in no industries do the
annualized costs of the revisions to the standard exceed one percent of
annual revenues or five percent of annual profits, either for small
entities or for very small entities. Similarly, under a cost scenario
exclusive of cost savings (shown in Tables VI-25 and VI-26), in no
industries do the annualized costs of the final rule exceed one percent
of annual revenues or five percent of annual profits. Because no
adverse revenue and profit impacts are expected to result from this
revision to the HCS, OSHA certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
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(B) Statement of the need for, and objectives of, the rule.
The HCS is the cornerstone of OSHA's risk mitigation strategy for
controlling hazardous chemicals in the workplace. The importance of
hazard communication in general and the HCS specifically have been well
established over the past few decades, ever since OSHA first
established the HCS in 1983 as a worker's ``right to know'' standard
(OSHA Publication 3021--Workers' Rights, 2017). However, even prior to
OSHA's promulgation of the HCS, there was recognition that workers
needed to know the hazards encountered in the workplace and the
importance of communicating, classifying, and training about how to
address those hazards.
The foundational goal of the HCS is to identify, understand, and
communicate the hazards associated with exposure to chemicals before
workers experience chronic exposure to those hazards. For further
discussion on the need for this revision to the HCS, see Section IV.,
Need and Support for the Revised Hazard Communication Standard, earlier
in this preamble.
(C) The response of the agency to any comments filed by the Chief
Counsel for Advocacy of the Small Business Administration in response
to the proposed rule, and a detailed statement of any change made to
the proposed rule in the final rule as a result of the comments.
No comments were filed by the Chief Counsel for Advocacy of the SBA
in response to the proposed rule.
(D) A statement of the significant issues raised by the public
comments in response to the initial regulatory flexibility analysis, a
statement of the assessment of the agency of such issues, and a
statement of any changes made in the proposed rule as a result of such
comments.
Significant issues raised by public comments in relation to the PEA
were addressed earlier in this FEA, within discussion of the
preliminary cost analysis and revisions (if any) to the
preliminary cost analysis in response to public comments.
(E) A description of and an estimate of the number of small
entities to which the rule will apply or an explanation of why no such
estimate is available.
As shown above in Table VI-2, OSHA estimates that 114,585
establishments within 106,017 private (business) firms/enterprises
defined as small by the SBA will be affected by the final rule.
As shown above in Table VI-3, OSHA estimates that 84,754 very small
establishments (fewer than 20 employees) within 83,952 private
(business) firms/enterprises identified as very small will be affected
by the final rule.
(F) A description of the projected reporting, recordkeeping and
other compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirements and
the type of professional skills necessary for preparation of the report
or record.
This final standard revises the HCS by, among other things,
updating the criteria for classification of certain chemical and
physical hazards, simplifying the requirements for providing updated
labels and labels for small containers, strengthening the awareness of
hazard information related to the contents of SDSs, and modernizing
definitions. The preamble to the final standard provides a
comprehensive description of, and further detail regarding, the
compliance requirements of the rulemaking.
Small business enterprises in Mining, Quarrying, and Oil and Gas
Extraction, Manufacturing, and Wholesale Trade who import, produce,
distribute, or otherwise come into contact with hazardous chemicals
will be subject to the requirements of the final standard. For details
on the affected NAICS industries and the number of affected small
business enterprises (firms), see Section VI.C., Profile of Affected
Industries, Establishments, and Employees in this FEA.
All affected establishments must have a written hazard
communication program explaining how the establishment meets the
criteria of the standard with respect to labeling, SDSs, and worker
information and training as discussed under paragraph (e) of the
standard.
Chemical manufacturers and importers must evaluate chemicals
produced in their workplaces or imported by them to classify the
chemicals in accordance with the standard. For each chemical, the
chemical manufacturer or importer must determine the hazard classes,
and, where appropriate, the category of each class that apply to the
chemical being classified. Employers are not required to classify
chemicals unless they choose not to rely on the classification
performed by the chemical manufacturer or importer for the chemical to
satisfy this requirement. A description of the types of entities
subject to the new and revised requirements, and the types of
professional skills necessary for compliance with the requirements, is
presented in the relevant sections of this economic analysis; the
corresponding unit time burdens are summarized below. These costs would
apply only to those businesses not already in compliance with the
revisions.
Costs associated with chemical reclassifications and related
revisions to safety data sheets and labels; Health and Safety
Specialist, fully loaded hourly wage of $61.18:
Medium establishments (100-499 employees): an average of
1.5 hours per SDS,
Small establishments (1-99 employees): an average of 2.1
hours per SDS.
Costs associated with revisions to appendix language on
precautionary statements and other mandatory language; Health and
Safety Specialist:
Medium establishments (100-499 employees): an average of
0.5 hours per SDS,
Small establishments (1-99 employees): an average of 0.7
hours per SDS.
Costs associated with management familiarization with the revisions
to the HCS; Health and Safety Specialist:
Medium directly affected establishments (20-499
employees): an average of 4.0 hours per establishment,
Medium indirectly affected establishments (20-499
employees): an average of 1.0 hours per establishment,
Small directly affected establishments (1-19 employees):
an average of 1.0 hours per establishment,
Small indirectly affected establishments (1-19 employees):
an average of 0.25 hours per establishment.
Training costs associated with the revisions to the HCS; Mining,
Quarrying, and Oil and Gas Extraction, and Manufacturing Sectors, per
affected firm:
2.5 hours, Health and Safety Specialist, fully loaded
hourly wage of $61.18;
0.2 hours, Logistics Personnel, fully loaded hourly wage
of $60.37;
0.2 hours, Production Worker, fully loaded hourly wage of
$31.09.
Cost savings associated with the released-for-shipment provision,
small firms in fertilizer and paint manufacturing, and small
wholesalers of related farm and paint supplies:
Percentage loss avoided ranging from 0.009 percent to
0.025 percent, applied to average product value.
Cost savings associated with abbreviated labels on very small
containers, small firms in six manufacturing industries within NAICS
325--Chemical Manufacturing:
Cost savings of $0.058 per label for very small containers
multiplied by the number of affected labels.
(G) A description of the steps the agency has taken to minimize the
significant economic impact on small entities consistent with the
stated objectives of the applicable statutes, including a statement of
the factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each one of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.
As was the case with the 2012 HCS, OSHA in this final rule has
published an implementation schedule (paragraph (j) Dates) that
minimizes the impacts on small employers. The final rule requires that
chemical manufacturers, importers, and distributors, and employers
evaluating substances be in compliance with all modified provisions of
the HCS no later than eighteen months after the effective date of the
final rule (paragraph (j)(2)(i)) and that chemical manufacturers,
importers, and distributors, and employers evaluating mixtures must be
in compliance with all modified provisions of the HCS no later than
thirty-six months after the effective date of the final rule (paragraph
(j)(3)(i)). Finally the final rule requires that all employers, as
necessary, update any alternative workplace labeling used under
paragraph (f)(6) of this section, update the hazard communication
program required by paragraph (h)(1), and provide any additional
employee training in accordance with paragraph (h)(3) for newly
identified physical hazard, or health hazards or other hazards covered
under this section no later than twenty-four months after the effective
date of the final rule for substances and forty-two months after the
effective date for mixtures (paragraphs (j)(2)(ii) and (j)(3)(ii)).
Taking into consideration all of the information received from the
public during the comment periods and in hearing testimony, as well as
the results of the economic analysis that examine the effects of
different compliance dates on the overall costs of compliance, OSHA
believes the implementation
schedule published in this final rule sets a proper balance between
employee safety and the economic interests of small business
enterprises.
VII. OMB Review Under the Paperwork Reduction Act of 1995
A. Overview
OSHA is publishing a final rule to revise the HCS, 29 CFR
1910.1200, which contains collections of information that are subject
to review by OMB under the Paperwork Reduction Act of 1995 (PRA), 44
U.S.C. 3501 et seq., and OMB regulations at 5 CFR part 1320. This rule
is revising and updating the existing previously approved paperwork
package under OMB control number 1218-0072.
The PRA defines collection of information to mean ``the obtaining,
causing to be obtained, soliciting, or requiring the disclosure to
third parties or the public of facts or opinions by or for an agency
regardless of form or format.'' 44 U.S.C. 3502(3)(A). Under the PRA, a
Federal agency cannot conduct or sponsor a collection of information
unless OMB approves it and the agency displays a currently valid OMB
control number (44 U.S.C. 3507). Also, notwithstanding any other
provision of law, no employer shall be subject to penalty for failing
to comply with a collection of information if the collection of
information does not display a currently valid OMB control number (44
U.S.C. 3512).
On February 16, 2021, OSHA published an NPRM (86 FR 9576) to modify
the HCS to align with Rev. 7 (Document ID 0060), to address issues that
arose during the implementation of the 2012 update to HCS, and to
better align with other U.S. agencies and international trading
partners, while improving the effectiveness of the standard. The NPRM
proposed to revise the OMB-approved information collection requirements
contained in the HCS. Specifically, OSHA proposed to (1) clarify that
under paragraph (d)(1) the chemical manufacturer or importer must
determine for each chemical the hazard classes, and where appropriate,
the category of each class, that apply to the chemical being classified
under normal conditions of use and foreseeable emergencies; (2) add
language to paragraph (f)(1) requiring that the chemical manufacturer,
importer, or distributor ensure labels on shipped containers bear the
date the chemical is released for shipment; (3) revise paragraph (f)(5)
by adding two new provisions related to bulk shipments of chemicals;
(4) revise paragraph (f)(11) by adding a provision related to release
for shipment that allows chemical manufacturers, importers, and
distributors to provide updated labels with each shipment instead of
relabeling; and (5) add new provisions allowing more limited labeling
for small containers in paragraph (f)(12). On February 16, 2021, the
agency prepared and submitted to OMB an Information Collection Request
(ICR) for the 2021 proposed rule for review in accordance with 44
U.S.C. 3507(d).
B. Solicitation of Comments
In accordance with the PRA (44 U.S.C. 3506(c)(2)), OSHA solicited
public comments on the collection of information contained in the NPRM.
OSHA encouraged commenters to submit their comments on the information
collection requirements contained in the proposed rule under docket
number OSHA-2019-0001, along with their comments on other parts of the
proposed rule. In addition to generally soliciting comments on the
collection of information requirements, the proposed rule indicated
that OSHA and OMB were particularly interested in comments that
addressed the following:
Whether the proposed collections of information are
necessary for the proper performance of the functions of the agency,
including whether the information is useful;
The accuracy of the OSHA's estimate of the burden (time
and cost) of the proposed collection of information, including the
validity of the methodology and assumptions used;
The quality, utility, and clarity of the information to be
collected; and
Ways to minimize the compliance burden on regulated
entities, including through the use of appropriate automated or other
technological techniques for collecting and transmitting information.
On August 4, 2021, OMB issued a Notice of Action (NOA) stating,
``Terms of the previous clearance remain in effect. Prior to
publication of the final rule, the agency should provide to OMB a
summary of all comments received on the proposed information collection
and identify any changes made in response to these comments'' (see
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202102-1218-002).
The agency received numerous public comments in response to the
NPRM during the initial comment period. In addition, OSHA held public
hearings on the proposal from September 21-23, 2021, where the agency
heard testimony from stakeholders (see Document ID 0423; 0424; 0425).
Participants who filed notices of intention to appear at the hearing
were permitted to submit additional evidence and data relevant to the
proceedings for a period of 60 days following the hearing. The record
remained open for the submission of final briefs, arguments, and
summations until December 22, 2021. OSHA received additional post-
hearing comments.
OSHA received one comment from Ameren specifically on the proposed
ICR, which stated that they agree with the collection of information
requirements listed in Table 1--Collection of Information Requirements
Being Revised in the Hazard Communication Standard in the NPRM,
although they noted that ``[t]his does not necessarily indicate that
Ameren agrees with these as a change to the HCS'' (Document ID 0309, p.
3).
The comments submitted in response to the rest of the proposed rule
and the hearing proceedings resulted in modifications to the provisions
containing collections of information. OSHA considered these responses
and resulting modifications when preparing the revised ICR for the
final rule. Summaries of comments received on the NPRM and OSHA's
responses are found in Sections VI., Final Economic Analysis and
Regulatory Flexibility Analysis, and Section XIV., Summary and
Explanation of the Final Rule, in this preamble.
OSHA submitted the final ICR concurrent with the publication of
this final rule, containing the full analysis and description of the
burden hours and costs associated with the final rule, to OMB for
approval. A copy of this ICR will be available to the public at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202002-1218-002 (this link
will become active on the day following publication of this notice). At
the conclusion of OMB's review, OSHA will publish a separate notice in
the Federal Register to announce the results.
C. Summary of Information Collection Requirements
As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the
following paragraphs provide information about the ICR.
1. Title: Hazard Communication Standard (29 CFR 1910.1200).
2. Description of the ICR: The final rule revises the currently
approved Hazard Communication ICR and changes the existing collection
of information requirements currently approved by OMB.
3. Brief Summary of the Information Collection Requirements:
This final rule revises and clarifies the collection of information
contained in the existing ICR. Specifically, OSHA is (1) modifying the
language in paragraph (d)(1) to clarify what hazards are required to be
classified; (2) adding language to paragraph (f)(1) providing that
hazards identified and classified under subparagraph (d)(1)(ii) do not
have to be addressed on labels of shipped containers; (3) revising
paragraph (f)(5) by adding two new provisions related to bulk shipments
of chemicals; (4) revising paragraph (f)(11) to include a provision
that adds flexibility related to updating labels for products already
released for shipment; (5) adding paragraph (f)(12) to provide new
labeling requirements for small containers; (6) clarifying the language
in paragraph (g)(2); and (10); and (7) adding language in paragraph (i)
to include requirements for how concentrations and concentration ranges
can be claimed as trade secrets on SDSs. See Table VII.1.
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1. OMB Control Number: 1218-0072.
2. Affected Public: Business or other for-profit.
3. Number of Respondents: 5,580,906.
4. Frequency of Responses: Varies.
5. Number of Reponses: 98,762,005.
6. Average Time per Response: Varies.
7. Estimated Annual Total Burden Hours: 7,206,569.
8. Estimated Annual Total Cost (Operation and maintenance):
$69,207,596.
VIII. Federalism
OSHA reviewed this final rule according to the Executive Order on
Federalism (E.O. 13132, 64 FR 43255, Aug. 10, 1999), which requires
that Federal agencies, to the extent possible, refrain from limiting
State policy options, consult with States before taking actions that
would restrict State policy options, and take such actions only when
clear constitutional and statutory authority exists and the problem is
of national scope. E.O. 13132 permits preemption of State law only as
provided by Congress or where State law conflicts with Federal law.
Federal agencies must limit preemption of State law to the minimum
level necessary to achieve the objectives of the statute pursuant to
which the regulations are promulgated.
Under section 18 of the OSH Act, 29 U.S.C. 667, Congress expressly
provides that States and U.S. territories may adopt, with Federal
approval, a plan for the development and enforcement of occupational
safety and health standards. OSHA refers to States that obtain Federal
approval for such OSHA-approved occupational safety and health plans as
``State Plans.'' Occupational safety and health standards developed by
State Plans must be at least as effective in providing safe and
healthful employment and places of employment as the Federal standards
and, when applicable to products that are distributed or used in
interstate commerce, must be required by compelling local conditions
and not unduly burden interstate commerce. 29 U.S.C. 667(c)(2). Subject
to these requirements, State Plans are free to develop and enforce
under State law their own occupational safety and health standards.
In States without OSHA-approved State Plans, Congress expressly
provides for OSHA standards to preempt State occupational safety and
health standards in areas addressed by the Federal standards. In these
States, this final rule limits State policy options in the same manner
as every standard promulgated by OSHA. In States with OSHA-approved
State Plans, this final rule does not significantly limit State policy
options to adopt equally effective or stricter standards.
OSHA previously concluded that promulgation of the HCS complies
with E.O. 13132 (77 FR 17687) and reaffirms that finding with respect
to this final rule.
IX. State Plans
When Federal OSHA promulgates a new standard or more stringent
amendment to an existing standard, OSHA-approved State Plans must
either amend their standards to reflect the new standard or amendment
or show OSHA why such action is unnecessary, e.g., because an existing
State standard covering this area is ``at least as effective'' as the
new Federal standard or amendment. 29 CFR 1953.5(a). State
Plans must adopt the Federal standard or complete their own standard
within six months of the promulgation date of the final Federal rule.
The 22 States and territories with OSHA-approved occupational
safety and health plans that cover public and private-sector employees
are Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky,
Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina,
Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont,
Virginia, Washington, and Wyoming. Another seven states and territories
have OSHA-approved occupational safety and health plans that cover
State and local government employees only: Connecticut, Illinois,
Maine, Massachusetts, New Jersey, New York, and the Virgin Islands.
This final rule updates the HCS to conform with updates to the GHS,
improve alignment with other U.S. agencies and international trading
partners, and address certain implementation concerns. This rule will
increase worker protection by improving the quality and consistency of
information provided to employers and employees regarding chemical
hazards and protective measures.
OSHA received one comment relevant to the relationship between
State Plans and Federal OSHA from the California Department of Public
Health/Hazard Evaluation System and Information Service (Cal/HESIS).
Cal/HESIS proposed that State Plans such as California be allowed to
require manufacturers that sell chemicals in their states or
territories to classify chemicals as carcinogens or reproductive or
developmental toxicants when the chemical is listed as such by a state
or territory body (such as California's Prop 65 list) and disclose this
information on SDSs (Document ID 0313, p. 8). OSHA disagrees with this
suggestion. As the agency discussed regarding State Plan amendments to
their hazard communication standards in the 2012 HCS ``OSHA intends to
closely scrutinize amendments to previously approved State hazard
communication standards submitted under current or future State plans
to ensure equal or greater effectiveness, including assurance that any
additional requirements do not conflict with, or adversely affect, the
effectiveness of the national application of OSHA's standard. OSHA must
also determine in its review whether any State plan standard provisions
that differ from the Federal provisions, when applicable to products
distributed or used in interstate commerce, are ``required by
compelling local conditions and do not unduly burden interstate
commerce.'' OSH Act section 18(c), 29 U.S.C. 667(c).'' (77 FR 17687).
The key benefit in aligning the HCS with the GHS in 2012 was to
provide a uniform and consistent method for classification and
dissemination of the information on the label and the SDS (77 FR
17605). Allowing states to develop their own classification criteria,
which could lead to vastly different and potentially contradictory
information on the labels, would diminish and eliminate significant
portions of those benefits. In 2012 stakeholders agreed that a dual
system would undermine the benefits of aligning with the GHS (77 FR
17583). OSHA also finds that if State Plans were allowed to require
different elements on labels and SDSs from state to state that this
could disrupt and unduly burden interstate commerce as it could mean
that manufacturers would need to develop different labels and SDSs
depending upon the state. Therefore, State Plans must adopt comparable
provisions within six months of publication of the final rule.
X. Unfunded Mandates Reform Act
OSHA reviewed this final rule according to the Unfunded Mandates
Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., and E.O. 13132 (64 FR
43255, Aug. 10, 1999). As discussed above in Section VI., Final
Economic Analysis and Regulatory Flexibility Analysis, OSHA has
concluded that this final rule will not impose a Federal mandate on the
private sector in excess of $100 million (adjusted annually for
inflation) in expenditures in any one year.
As noted above in Section IX., State Plans, OSHA's standards do not
apply to State and local governments except in States that have elected
voluntarily to adopt a State Plan approved by the agency. Consequently,
this proposal does not meet the definition of a ``Federal
intergovernmental mandate.'' See 2 U.S.C. 658(5).
For the reasons discussed above in Section VI., Final Economic
Analysis and Regulatory Flexibility Analysis, the changes to the HCS
would not require tribal governments to expend, in the aggregate, $100
million or more in any one year for their commercial activities.
Therefore, for the purposes of the UMRA, OSHA certifies that this
final rule would not mandate that State, local, or tribal governments
adopt new, unfunded regulatory obligations of, or increase expenditures
by the private sector by, more than $100 million in any year.
XI. Protecting Children From Environmental Health and Safety Risks
E.O. 13045 (62 FR 19885, Apr. 23, 1997), requires that Federal
agencies submitting covered regulatory actions to OMB's Office of
Information and Regulatory Affairs (OIRA) for review pursuant to E.O.
12866 provide OIRA with (1) an evaluation of the environmental health
or safety effects that the planned regulation may have on children, and
(2) an explanation of why the planned regulation is preferable to other
potentially effective and reasonably feasible alternatives considered
by the agency. E.O. 13045 defines ``covered regulatory actions'' as
rules that are likely to (1) be economically significant under E.O.
12866 (now amended by E.O. 14094) (i.e., a rulemaking that has an
annual effect on the economy of $200 million or more, or would
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities), and (2) concern an environmental health risk or safety
risk that an agency has reason to believe may disproportionately affect
children. In this context, the term ``environmental health risks and
safety risks'' means risks to health or safety that are attributable to
products or substances that children are likely to come in contact with
or ingest (e.g., through air, food, water, soil, or product use).
OIRA has determined that this final rule is not significant under
Section 3(f)(1) of E.O. 12866, as amended (see Section VI., Final
Economic Analysis and Regulatory Flexibility Analysis) and that the
environmental health and safety risks addressed through this final rule
do not present a disproportionate risk to children as set forth in E.O.
13045.
XII. Environmental Impacts
OSHA has reviewed this final rule according to the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.), the
regulations of the Council on Environmental Quality (40 CFR part 1500),
and DOL's NEPA procedures (29 CFR part 11). In the NPRM, OSHA
preliminarily determined that the proposed regulatory changes would
have no impact on air, water, or soil quality; plant or animal life; or
the use of land or aspects of the external environment and thus would
have no significant environmental impacts (86 FR 9687). No commenter
challenged this determination. Based on its review of the final rule,
OSHA has determined
that the regulatory changes will have no impact on air, water, or soil
quality; plant or animal life; the use of land; or aspects of the
external environment and the final rule will therefore have no
significant environmental impact.
XIII. Consultation and Coordination With Indian Tribal Governments
OSHA reviewed this final rule in accordance with E.O. 13175 (65 FR
67249, Nov. 6, 2000) and determined that it does not have tribal
implications as defined in that order. The final rule will not have
substantial direct effects on one or more Indian tribes, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes (see E.O. 13175 Sec. 1(a)).
XIV. Summary and Explanation of the Final Rule
This section of the preamble explains OSHA's changes to the HCS (29
CFR 1910.1200). OSHA proposed to align this update of the HCS with the
GHS Rev. 7 (Document ID 0060), where appropriate. The agency had
preliminarily decided to base most of the GHS alignment on Rev. 7 for
several reasons, even though Rev. 8 was issued in July 2019 (Document
ID 0065). First, OSHA had preliminarily determined that there were
sufficient significant updates to the GHS to warrant the initiation of
the rulemaking process and OSHA began its work to update the standard
prior to the release of Rev. 8. Second, the U.S.'s major trading
partners (including Canada, Europe, and Australia) have or are
preparing to align with Rev. 7 (Document ID 0172; Document ID 0168;
Document ID 0176). While the proposal was largely based on Rev. 7, OSHA
asked for comment on adopting some of the most consequential changes
from Rev. 8 in the Issues and Options section (86 FR 9691-9694).
In addition, OSHA proposed several changes that were unrelated to
alignment with the GHS but were intended to address specific issues
that have arisen since the 2012 rulemaking to revise the HCS and to
provide better alignment with international trading partners, without
lowering the protections provided by the standard.
OSHA received numerous comments on which GHS revision to align with
in this rulemaking and received overwhelming support from commenters
for its proposal to update to Rev. 754 \54\ (See, e.g., Document ID
0293, p. 1; 0327, pp. 1-2; 0359, p. 7; 0339, p. 1; 0323, p. 1; 0281,
Att. 2, p. 2; 0358, p. 2). The most prevalent reasons given for
supporting the update to Rev. 7 were better alignment with
international trading partners, especially Health Canada's HPR, and
improvements in hazard communications such as updating and adding
additional hazard classes with the updates to the GHS. Specifically,
Givaudan and the Household & Commercial Products Association (HCPA)
supported alignment with Rev. 7 in order to increase consistency
between OSHA's HCS and Health Canada's HPR (Document ID 0293, p. 1;
0327, pp. 1-2). Similarly, Dow Chemical (Dow) supported alignment with
Rev. 7 on the basis that OSHA's proposed update would improve alignment
with major trading partners (Document ID 0359, p. 7). Hach and the
Dangerous Goods Advisory Council (DGAC) also supported the update to
Rev. 7 to better align with trading partners (Document ID 0323, p. 1;
0339, p. 1).
---------------------------------------------------------------------------
\54\ Comments regarding specific adoption of particular
provisions are discussed in the appropriate sections of the Summary
and Explanation.
---------------------------------------------------------------------------
Only two commenters objected to OSHA's proposal to align with Rev.
7. Toby Threet stated that OSHA should not adopt Rev. 7 because the
agency should strive to align as closely as possible with other
countries in order to meet the goal of GHS harmonization and argued
that OSHA has not shown that the majority of other countries have
aligned with Rev. 7, both because (1) at the time OSHA issued the NPRM
several countries were preparing to align with Rev. 7 but had not yet
(Canada, Europe, Australia, and New Zealand) and (2) OSHA failed to
consider whether this would align with other, potentially more major,
trading partners (such as China, Russia, Brazil, and India) (Document
ID 0279, pp. 1-2).
OSHA disagrees with this comment. As indicated in the NPRM, Canada,
Europe, Australia, and New Zealand all announced their intention to
update their regulations to Rev. 7 (86 FR 9694). The U.S.'s closest
trading partner, Canada, updated the HPR to align with Rev. 7 on
January 4, 2023 (see https://www.canada.ca/en/health-canada/services/environmental-workplace-health/occupational-health-safety/workplace-hazardous-materials-information-system/amendments-hazardous-products-regulations.html), and the European Union (EU) updated its
Classification, Labelling, and Packaging (CLP) regulation in 2023 as
well (see https://echa.europa.eu/new-hazard-classes-2023). OSHA works
diligently with our UN partners through the UNSCEGHS to address
stakeholder concerns regarding the timing of updates across U.S.
international trading partners. However, given the lengthy and complex
process of regulatory development, exact timelines are difficult to
manage. Nevertheless, OSHA does not believe that there will be
meaningful differences in timing of updates between the international
trading partners as OSHA's compliance deadline will allow stakeholders
extended time to comply with the updated standard. The compliance dates
for the HCS are discussed in more detail in the Summary and Explanation
for paragraph (j).
Additionally, Brazil and Russia are currently in the process of
aligning with Rev. 7, further indicating that this is the correct
revision for OSHA to align with. China is using the fourth version of
the GHS and therefore is currently not aligned with OSHA's HCS. India
has not yet implemented the GHS and does not participate at the
UNSCEGHS. OSHA does not believe it is acceptable to postpone its
rulemaking until all trading partners, particularly those that have
never adopted the GHS, adopt Rev. 7 as this would result in OSHA not
updating the HCS for an indefinite period of time, meanwhile depriving
U.S. workers of these important protections. While OSHA strives to
align with major trading partners that are similarly committed to
maintaining a harmonized GHS system where possible, the agency's
primary mission is to protect workers.
ASSP also stated that OSHA should not align with GHS Rev. 7. They
suggested that the agency should align with Rev. 8 because it is a
newer version (Document ID 0284, p. 1). ASSP went on to state that
updating to Rev. 7 would result in OSHA continuing to play `catch-up'
since the European Union's Registration, Evaluation, Authorisation, and
Restriction of Chemicals (REACH) regulation is updated every two years.
OSHA notes that currently Health Canada HPR and the EU CLP have updated
to Rev. 7, so the agency does not agree that the United States is
falling behind its trading partners (Document ID 0176; 0172).
Other commenters expressed concerns about deviating from a single
version of the GHS, either due to incorporating elements of another
revision or due to incorporating elements that differed from the GHS
altogether. Several commenters noted that they disapproved of
selectively adopting elements of Rev. 8, and two of
these commenters noted that this was because selective adoption would
cause misalignment with trading partners (Document ID 0323, p. 2; 0423,
Tr. 105; 0359, p. 7; 0368, p. 11). However, Ameren noted that adopting
specific provisions from Rev. 8 ``could improve worker safety now in
lieu of waiting until the next revision of the HCS'' (Document ID 0309,
p. 14). While OSHA strives to align with trading partners where
possible, OSHA's primary mission is to protect workers. Therefore, OSHA
has concluded that some elements of Rev. 8 improve the safety of
workers and the clarity of information being communicated and is
adopting those provisions instead of their Rev. 7 equivalent.
Other stakeholders indicated that OSHA should not include changes
that are not included in the GHS. The International Carbon Black
Association (ICBA) supported alignment with Rev. 7, but opposed adding
the sections of the proposal, such as the requirement to classify
hazards based on downstream use, that went beyond GHS obligations
because they felt this would lead to misalignment with international
trading partners (Document ID 0291, p. 6). ACC provided similar
comments and stated that ``we strongly urge OSHA to pull directly from
the UN GHS wherever possible, while retaining flexibility for existing
provisions that provide similar levels of protection'' (Document ID
0347, p. 4). NAIMA supported aligning with the GHS, but noted that
``[t]here are also proposals from OSHA that have nothing to do with the
GHS but will create heavy and unprecedented burdens upon all industries
subject to the HCS'' and stated that they did not support such changes
(Document ID 0338, p. 1). These commenters provided greater specificity
about their opposition to specific proposals that differ from Rev. 7,
and OSHA discusses these specific comments in detail in the
corresponding sections in the Summary and Explanation below.
OSHA received several comments asking the agency to completely
withdraw the proposal or repropose it with significant changes due to
concerns about the proposed rule decreasing worker protections
(Document ID 0305, p. 1; 0312, p. 7; 0322, Att. 1, p. 1; 0344, p. 4;
0350, p. 1; 0354, p. 1). OSHA disagrees with the conclusion that this
rule will decrease worker protections; as the agency has stated, and as
discussed throughout the Summary and Explanation below, it expects this
update of the HCS to improve worker safety by incorporating new hazard
classes and categories, improving and streamlining precautionary
statements, and providing additional clarification of existing
regulatory requirements. Therefore, OSHA is moving forward with
finalizing the update to the HCS in this rulemaking. To the extent
these commenters raised concerns about worker safety with respect to
specific provisions, those comments are addressed in their respective
sections of the Summary and Explanation.
Finally, OSHA received a variety of non-substantive comments
pointing out minor errors such as missing punctuation or European
spelling differences. OSHA has updated the regulatory text to
incorporate these minor changes where appropriate, but does not discuss
non-substantive edits in the Summary and Explanation below.
A. Discussion of Incorporation by Reference
OSHA is updating the agency's incorporation by reference section,
29 CFR 1910.6, to include the national and international consensus
standards listed below. Where OSHA has updated consensus standards,
OSHA does not intend to require chemicals already classified using an
earlier version of a consensus standard to be reclassified and has
retained earlier versions of the consensus standards in the text of the
standard where relevant to avoid suggesting retesting is necessary (for
the U.N. Recommendations on the Transport of Dangerous Goods, Manual of
Tests and Criteria, this is reflected in the use of a generic citation
where either Rev. 4 or Rev. 6 is acceptable, and a specific citation to
Rev. 6 where there is new material included and only Rev. 6 is
acceptable to use). OSHA believes that requiring the reclassification
of chemicals based on updated test methods could result in unnecessary
economic impacts and create unnecessary confusion for stakeholders.
OSHA had considered alternative ways to clarify this in the final
regulatory text, for instance by including a provision in the DATES
section of the rule stating that chemicals classified based on older
test methods, prior to the effective date of the rule, do not need to
be reclassified, and invited comments on this topic (86 FR 9694). OSHA
received one comment from Ameren on this issue (Document ID 0309, p.
14), which is addressed in the Summary and Explanation for Appendix B.
OSHA has decided to not make the change to the DATES section but rather
to retain references to the older versions of the consensus standards
where relevant and has clarified this matter in the relevant portions
of the Summary and Explanation for Appendix B.
In the NPRM, OSHA requested comment on whether it should update all
of the consensus standards and received no comments on that particular
question. ASTM International (ASTM) submitted a comment indicating that
they believe OSHA should, in the future, update all references to
consensus standards in bulk through the Federal Register, as the Food
and Drug Administration (FDA) does (Document ID 0307, pp. 2-3). OSHA
has decided to only add or update the references that the agency
proposed, rather than updating all existing references to consensus
standards in the regulatory text and Appendix B, but will consider the
approach suggested by ASTM in a future rulemaking. OSHA is finalizing
the proposed references to the consensus standards as proposed with one
exception: DOD pointed out that one of OSHA's proposed citations to
consensus standards was incorrect and OSHA has updated the reference
throughout the final rule (Document ID 0299, p. 3).
OSHA is finalizing its decision to incorporate by reference the
materials below. Each standard is available for purchase through the
publication agencies listed below.
The following standards appear in the amendatory text of this
document and were previously approved for appendix B to Sec.
1910.1200: ASTM D56-05; ASTM D3278-96, ASTM D3828-07a, ASTM D93-08,
ASTM D86-07a, ASTM D240-02 (Reapproved 2007), ASTM D1078-05, ISO
1056:1996(E) ISO 1056-2:2005, ISO 13943:2000(E/F), NFPA 30B, UN ST/SG/
AC.10/Rev.4.
ADR 2019, European Agreement Concerning the International
Carriage of Dangerous Goods by Road, Annex A, January 1, 2019.
This standard describes test methods, units of measurement,
definitions, and applicable standards and regulations for determining
fluidity of liquids for classification purposes.
[cir] United Nations: https://shop.un.org/product/18246?v=22452 r.
ASTM D 4359-90 (reapproved 2019), Standard Test Method for
Determining Whether a Material is a Liquid or a Solid, Approved July 1,
2019.
This standard covers test methods used to determine whether a
viscous material is a liquid or a solid for regulatory purposes and was
developed under internationally recognized principles established in
``Decision on Principles for the Development of International
Standards, Guides and Recommendations'' by the World Trade Organization
Technical Barriers to Trade (TBT) Committee. The standard
only addresses test methods for the specified purpose of determining
state of a material and is not intended to address all safety concerns
associated with use of the material being tested.
[cir] ASTM International: https://astm.org/Standard/standards-and-publications.html.
DIN 51794:2003-05, Determining the ignition temperature of
petroleum products, May 2003.
This standard specifies test methods for determining the ignition
temperature of flammable gases and liquids, as well as petroleum
products and their mixtures at temperatures between 75 [deg]C and 650
[deg]C. The ignition temperature is a measurement of a flammable
substance's tendency to ignite when in contact with hot objects. The
standard also provides guidance for classification purposes.
[cir] German Institute for Standardisation (DIN): https://din.de/en/about-standards/buy-standards.
IEC 60079-20-1, Explosive atmospheres--Part 20-1: Material
characteristics for gas and vapor classification--Test methods and
data, Edition 1.0, 2010-01 This standard describes test methods for
measurement of the maximum experimental safe gaps of a gas- or vapor-
air mixture under normal conditions of temperature and pressure in
order to make a determination of appropriate safety equipment as well
as describes test methods for use in the determination of auto-ignition
temperature of a chemically pure vapor or gas. This standard also
provides guidance for classifying gases and vapors for explosive
potential.
[cir] International Electrotechnical Commission (IEC): https://webstore.ansi.org/standards/iec/iec6007920ed2010.
ISO 817:2014(E), Refrigerants--Designation and safety
classification, Third Edition, 2014-04-15.
This standard provides guidance for determining the lowest
temperature a substance can spontaneously ignite under normal
atmospheric conditions without an external source of ignition, such as
a spark or flame. The standard also provides guidance for
classification of these materials for safety purposes. The standard was
developed under internationally recognized principles established in
``Decision on Principles for the Development of International
Standards, Guides and Recommendations'' by the World Trade Organization
Technical Barriers to Trade (TBT) Committee.
[cir] ISO: https://iso.org/store.html.
[cir] ISO 10156:2017(E), Gases and Gas Mixtures--Determination of
Fire Potential and Oxidizing Ability for the Selection of Cylinder
Valve Outlets, Fourth Edition, 2017-07.
This standard provides test methods for determining the
flammability of a gas or gas mixture and determining whether a gas or
gas mixture is more or less oxidizing than air under atmospheric
conditions. The standard also provides guidance for classifying gases
or gas mixtures and for determining the appropriate selection of gas
cylinder valve outlets. The standard was developed under
internationally recognized principles established in ``Decision on
Principles for the Development of International Standards, Guides and
Recommendations'' by the World Trade Organization Technical Barriers to
Trade (TBT) Committee.
[cir] International Organization for Standardization (ISO): https://iso.org/store.html.
UN ST/SG/AC.10/11/Rev.6, UN Recommendations on the
Transport of Dangerous Goods, Manual of Tests and Criteria, Sixth
Revised Edition, copyright 2015.
This standard provides test methods, classification procedures, and
criteria for classification of explosives, self-reactive substances,
organic peroxides, and other various hazards (e.g., flammability of
aerosols, desensitized explosives, flammable solids, liquids, oxidizing
solids and liquids, corrosive to metals).
[cir] United Nations: https://unece.org/info/Transport/Dangerous-Goods/pub/2581.
OSHA is making all documents available for review by the public in
accordance with the agency's policies regarding availability of
documents. Copies of the standards are available for purchase from the
issuing organizations at the addresses or through the other publisher
contact information listed in Sec. 1910.6 of the amendatory text in
this document. In addition, these standards are available for
inspection at any Regional Office of the Occupational Safety and Health
Administration (OSHA), or at the OSHA Docket Office, U.S. Department of
Labor, 200 Constitution Avenue NW, Room N-3508, Washington, DC 20210;
telephone: 202-693-2350 (TTY number: 877-889-5627). Due to copyright
issues, OSHA cannot post consensus standards on the OSHA website or
through regulations.gov.
B. Discussion of Regulatory Text
(a) Purpose
Paragraph (a)(1) of the HCS states that ``[t]he purpose of this
section is to ensure that the hazards of all chemicals produced or
imported are classified, and that information concerning the classified
hazards is transmitted to employers and employees.'' In the 2012 HCS,
paragraph (a)(1) explained that the requirements of the standard were
intended to be consistent with Rev. 3. The NPRM proposed to change the
reference from Rev. 3 to Rev. 7. As stated in the introduction to the
Summary and Explanation, revisions included in this final rule
primarily serve to align the HCS with Rev. 7, with the exception of
selected provisions which either align with Rev. 8 or do not relate to
the GHS. OSHA is therefore finalizing paragraph (a)(1) to update the
reference to the GHS to ``Revision 7,'' replacing ``Revision 3.'' In
addition, OSHA is inserting ``primarily'' before ``Revision'' because
the agency is finalizing some of the proposed changes from Rev. 8.
(b) Scope and Application
Paragraph (b) of the HCS specifies the scope and application of the
rule, including the chemicals that are (and are not) covered by the
standard. This final rule modifies paragraph (b)(6)(x) of the 2012 HCS,
which excludes nuisance particulates from coverage under the HCS under
certain circumstances. Specifically, OSHA is modifying paragraph
(b)(6)(x) to clarify that nuisance particulates are excluded from the
scope of the standard when the chemical manufacturer or importer can
establish they do not pose any physical hazard, health hazard, or other
hazards covered under the HCS.
Paragraph (b)(6)(x) of the 2012 HCS stated that the standard does
not apply to nuisance particulates ``where the chemical manufacturer or
importer can establish that they do not pose any physical or health
hazard covered under this section.'' However, this could be interpreted
as excluding hazards not otherwise classified (HNOC), which is not
OSHA's intent. Therefore, in the NPRM OSHA proposed a slight revision
to this provision to make clear that nuisance particulates are excluded
if they do not pose any physical hazard, health hazard, or other
hazards (i.e., HNOC) covered by the standard (86 FR 9696). This
proposed change was intended to clarify that all hazards covered by the
standard must be considered when evaluating nuisance particulates.
OSHA's proposal did not alter the requirement, first adopted in 1994,
that nuisance particulates are excluded if they pose no hazard.
OSHA received no comments specifically regarding the addition of
HNOC to this provision. However, OSHA received comments regarding
paragraph (b)(6)(x) as a whole (Document ID 0325, pp. 12-13; 0397, pp.
12-13; 0279, p. 13). USBSA et al. commented that OSHA's proposal to add
``other hazards'' to the existing text of paragraph (b)(6)(x) would
``contravene the burden-of-proof provision of the Administrative
Procedure Act, 5 U.S.C. 556(d)'' \55\ (Document ID 0325, pp. 12-13;
0397, pp. 12-13). USBSA et al. argued that OSHA's proposed change would
improperly place the burden of proof on manufacturers and importers to
determine whether nuisance particulates present ``other hazards'' under
the HCS, in order to meet the requirements of (b)(6)(x) for when
nuisance particulates may be excluded from the scope of the HCS
(Document ID 0325, p. 12).
---------------------------------------------------------------------------
\55\ The ``burden of proof'' provision to which USBSA et al.
referred is located in 5 U.S.C. 556, which applies to federal agency
hearings. See 5 U.S.C. 556(a). The provision states, in pertinent
part, ``Except as otherwise provided by statute, the proponent of a
rule or order has the burden of proof.'' 5 U.S.C. 556(d).
---------------------------------------------------------------------------
Similarly, Toby Threet commented that paragraph (b)(6)(x) requires
the manufacturer or importer to establish the absence of a hazard and
suggested that OSHA should revise the paragraph to exclude nuisance
particulates where the chemical manufacturer or importer can establish
that they are not classified as a physical hazard, health hazard, or
any other hazards covered under the HCS. According to Threet, ``the
requirement to `establish' the absence of a hazard'' suggests that OSHA
is intending to mandate testing, which the HCS does not require
(Document ID 0279, p. 13).
OSHA disagrees with these comments. First, both comments pertain to
aspects of paragraph (b)(6)(x) that have been part of the HCS since
1994 and that OSHA's proposed change does not affect. Regardless,
contrary to USBSA et al.'s contention, paragraph (b)(6)(x) does not
improperly shift the burden of proof onto the chemical manufacturer or
importer. As USBSA et al. recognized, courts considering similar
language in other OSHA standards have rejected the same argument. They
have done so based on the well-established principle that the party
seeking to claim an exemption from a legal requirement bears the burden
of demonstrating it applies. See Triumph Constr. Corp. v. Sec'y of
Labor, 885 F.3d 95, 98 (2d Cir. 2018); Harry C. Crooker & Sons v.
OSHRC, 537 F.3d 79, 86 (1st Cir. 2008). Paragraph (b)(6)(x) is such an
exemption (see 59 FR 6154 (stating in promulgation the provision that
``the burden of proof for this exemption belongs to the manufacturer or
importer'')).
Likewise, contrary to Threet's assertion, paragraph (b)(6)(x) does
not establish testing requirements or otherwise affect methods of
classification under the HCS, as OSHA made clear when promulgating the
provision in 1994 (59 FR 6126 (``The hazard evaluation process for
nuisance particulates is not any different than for any other
chemical.'')). Therefore, the suggestion to change the words ``do not
pose'' to ``are not classified'' is unnecessary and OSHA declines to
adopt it. OSHA's addition of ``other hazards'' to this paragraph is
merely clarifying that nuisance particulates also must not pose an
HNOC. Because the revision will clarify OSHA's original intent and
ensure that nuisance particulates posing a combustible dust hazard or
an HNOC are properly addressed by the standard, OSHA is finalizing
paragraph (b)(6)(x) as proposed.
OSHA received several additional comments that are related to
paragraph (b), but that are outside the scope of this rulemaking. An
anonymous submitter commented that they support the rule and stated
that ``all chemical labels should follow the same guidelines and get
approved before being used [in] an . . . establishment or put on a
shelf'' (Document ID 0296). OSHA interprets this comment as supporting
its proposal, but to the extent that the commenter was suggesting that
OSHA should apply the HCS to all chemicals in the United States or that
it should approve the labels before they are placed on chemicals, these
suggestions are outside the scope of this rule because they would
involve fundamental changes to the HCS that OSHA has not proposed and
in some cases does not have the authority to do.
NAIMA commented that the HCS should apply to all labels within the
U.S. Specifically, NAIMA commented that OSHA should not cede labeling
authority for products regulated by other agencies and should not allow
states to create additional requirements for labelling or
classification requirements (Document ID 0338, pp. 11-12). Both of
these suggestions are outside the scope of this rulemaking as the
agency did not propose anything related to these issues. Additionally,
OSHA only has jurisdiction to address the occupational hazards posed by
chemicals and, even in that sphere, is in some cases preempted from
enforcing safety and health standards where other Federal agencies
exercise statutory authority (see 29 U.S.C. 653(b)(1)). OSHA cannot
mandate how other agencies address labeling issues under their
jurisdiction, and it already exercises its authority over State Plans
in order to ensure that no states create requirements that conflict
with the HCS.
OSHA received several comments on pesticide labels and SDSs and
consumer product labeling (e.g., Document ID 0275; 0343, pp. 3-4; 0331,
pp. 2-3; 0407, p. 9; 0341; 0340, pp. 3-4). As discussed in the 2012
HCS, OSHA and EPA have worked together to provide guidance to the
regulated communities on preparing labels and SDSs for pesticide
products (77 FR 17696-17697). In addition, consumer product labeling is
outside of OSHA's jurisdiction. Since OSHA did not propose to address
these issues in the NPRM, these comments are out of scope for this
rulemaking and the agency declines to take any of the requested
actions.
(c) Definitions
Paragraph (c) of the HCS provides definitions for terms used
throughout the rest of the HCS. Paragraph (c) is designed to increase
stakeholders' comprehension of requirements under the HCS and improve
compliance with the standard. Many of the definitions in paragraph (c)
align with the GHS, but some are unique to the HCS. For definitions
that are specifically related to individual health and physical hazards
please see Appendices A and B.
In the NPRM, OSHA proposed modifications to three existing
definitions in paragraph (c), the addition of definitions for eight new
terms, and the deletion of one definition. OSHA proposed modifications
to: exposure or exposed, hazardous chemical, and physical hazard. The
eight new terms proposed were: bulk shipment, combustible dust, gas,
immediate outer package, liquid, physician or other licensed health
care professional (PLHCP), released for shipment, and solid. OSHA
proposed to delete the definition of pyrophoric gas.
For the reasons discussed in the remainder of this section, OSHA is
finalizing the definitions of bulk shipment, exposure or exposed, gas,
hazardous chemical, immediate outer package, physician or other
licensed health care professional (PLHCP), released for shipment, and
solid as proposed. In addition, OSHA is eliminating the definition of
pyrophoric gas as proposed. The agency is finalizing the definitions of
combustible dust, liquid, and physical hazard with changes from the
NPRM based on comments the agency received. These definitions are
discussed below in alphabetical order.
Bulk shipment. OSHA proposed adding a definition of the term bulk
shipment to the standard. The proposed definition stated that bulk
shipment means any hazardous chemical transported where the mode of
transportation (vehicle) comprises the immediate container (i.e.,
contained in tanker truck, rail car, or intermodal container). This
definition clarifies paragraph (f)(5)(ii), which OSHA proposed in the
NPRM to explain that labels for bulk shipments need not be placed on
the immediate container but may instead be transmitted with the
shipping papers or bills of lading or by other technological or
electronic means, as long as the label is immediately available to
workers in printed form at the receiving end of the shipment. The
proposed definition also distinguishes OSHA's bulk shipment
requirements from the DOT's Pipeline and Hazardous Materials Safety
Administration (PHMSA) requirements for bulk packaging (49 CFR parts
100-185).
OSHA received multiple comments on this proposed definition. The
Fragrance Creators Association (FCA) requested clarification as to
whether the proposed definition of bulk shipment would encompass
intermediate bulk containers (IBCs). An IBC is ``a rigid or flexible
portable packaging, other than a cylinder or portable tank, which is
designed for mechanical handling'' (49 CFR 171.8), typically holding
110-350 gallons (Document ID 0345, p. 5). According to FCA, these IBCs
are commonly placed into inventory as-is, and therefore should be
labeled to ensure employee health and safety (Document ID 0345, pp. 5-
6). OSHA intends the definition of ``bulk shipment'' to apply only when
the mode of transportation is the immediate container, such as a tanker
truck, rail car, or intermodal container. Therefore, IBCs do not fall
within OSHA's definition of a bulk shipment.
DGAC, Interested Parties for Hazardous Materials Transportation
(IPHMT), NACD, and NPGA suggested that OSHA should adopt DOT's
definition of ``bulk packaging'' (Document ID 0339, pp. 1-2; 0423, Tr.
62; 0336, pp. 3-4; 0329, pp. 2-3; 0423, Tr. 124; 0465, pp. 2-3; 0364,
pp. 6-7; 0423, Tr. 229). DOT defines ``bulk packaging'' as: ``a
packaging, other than a vessel or a barge, including a transport
vehicle or freight container, in which hazardous materials are loaded
with no intermediate form of containment. A Large Packaging in which
hazardous materials are loaded with an intermediate form of
containment, such as one or more articles or inner packagings, is also
a bulk packaging. Additionally, a bulk packaging has:
(1) A maximum capacity greater than 450 L (119 gallons) as a
receptacle for a liquid;
(2) A maximum net mass greater than 400 kg (882 pounds) and a
maximum capacity greater than 450 L (119 gallons) as a receptacle for a
solid; or
(3) A water capacity greater than 454 kg (1000 pounds) as a
receptacle for a gas as defined in Sec. 173.115 of this subchapter.''
49 CFR 171.8.
NACD expressed concern that OSHA's proposed definition of ``bulk
shipment'' would conflict with DOT's definition of ``bulk packaging''
(Document ID 0329, pp. 2-3; 0465, pp. 2-3; 0423, Tr. 124). DGAC stated
that the definition of bulk shipment ``should be similar or identical
to those contained in the DOT regulations in Section 171 of the
Hazardous Materials Regulations . . . [because] many of the packaging
described as bulk are used for international movement of hazardous
materials, but they're also used as a containment system in
manufacturing. So to have different definitions would create problems''
(Document ID 0423, Tr. 62). NPGA and IPHMT suggested that OSHA
incorporate the DOT definition, on the basis that incorporation would
provide clarity on requirements for bulk shipments where both HCS and
DOT's Hazardous Materials Regulations (HMR) requirements apply; would
offer uniformity in the training and education of workers on the types
of containers and the required information to be displayed for bulk
shipments; and would allow for updates to the definition of bulk
shipment without requiring revision to the HCS (Document ID 0336, pp.
3-4; 0364, pp. 6-7). They also noted that the definition of bulk
shipment needed to be ``clear between the agencies'' in order to codify
the joint DOT and OSHA policy from a 2016 guidance document regarding
labeling of bulk chemical shipments (Document ID 0244).
OSHA disagrees with these comments. The agency intends for its
definition of bulk shipment to differ from DOT's definition of bulk
packaging, as DOT's definition would not adequately support OSHA's
requirements in HCS paragraph (f)(5)(ii). OSHA's use of the term bulk
shipment solely refers to situations where the mode of transportation
is also the immediate container, while DOT's definition for bulk
packaging encompasses a broader range of forms of packaging, including
those with an intermediate form of containment such as 55-gallon drums
or super sacks (flexible intermediate bulk containers) which can hold
over a ton of material. OSHA only intends to create an exception in
(f)(5)(ii) for shipments that do not have intermediate forms of
packaging. Thus, adopting the DOT definition would not align with
OSHA's intent and would provide less information to workers. The
guidance created with DOT in 2016 does not conflict with this
interpretation and a single definition is not required in order to
codify it, as suggested by NPGA and IPHMT. That guidance uses the terms
bulk shipment and bulk packaging correctly to refer to each agency's
separate definitions and does not use the terms interchangeably.
Therefore, OSHA is declining to adopt the suggestion that the agency
incorporate or otherwise align with the DOT definition for bulk
packaging and is finalizing the definition of bulk shipment as
proposed.
Combustible dust. OSHA proposed adding a definition of the term
combustible dust to the HCS. In the 2012 update to the HCS, OSHA
included combustible dust under the definition of hazardous chemical,
but did not provide a separate definition of the term. At that time,
OSHA did not include a definition of combustible dust because the
agency was considering a separate combustible dust rulemaking, OSHA had
already begun work at the GHS on a definition for combustible dust, and
the UNSCEGHS was also considering combustible dust classification and
communication issues (see 77 FR at 17705). Additionally, OSHA explained
that it had previously provided considerable guidance on the nature and
definition of combustible dust in a variety of materials, including
OSHA's Hazard Communication Guidance for Combustible Dusts (77 FR
17704). Since the 2012 rulemaking, however, OSHA has not promulgated a
combustible dust standard and the UNSCEGHS has adopted a definition for
combustible dust.
Rev. 7 defines combustible dust as ``finely divided solid particles
of a substance or mixture that are liable to catch fire or explode on
ignition when dispersed in air or other oxidizing media'' (Document ID
0060). In the NPRM, OSHA preliminarily determined that the definition
developed in the GHS was consistent with existing OSHA guidance on
combustible dust hazards and proposed adopting this definition (86 FR
9697; Document ID 0190; 0255). In addition, OSHA has other standards
that use the term combustible dust but do not define the term (e.g.,
Grain Handling Facilities, 29 CFR 1910.272). In the NPRM, OSHA
preliminarily
determined that the proposed definition was consistent with uses of the
term in other standards (86 FR 9696). While OSHA still believes the
final definition to be consistent with other standards' use of the
term, the agency wishes to clarify its position should inconsistencies
arise or become evident. Where the term combustible dust is used but
not defined in another standard, and where OSHA has guidance specific
to that standard, that guidance, rather than the HCS definition, is the
relevant interpretive source.
OSHA received comments from ACC, API, and DGAC supporting the
proposed addition of a combustible dust definition consistent with Rev.
7 (Document ID 0347, pp. 26-27; 0316, p. 2; 0339, p. 1). The agency
also received several critical comments. First, several commenters
believed that the proposed definition for combustible dust was
confusing, ambiguous, and too broad (Document ID 0287, pp. 2-4; 0325,
pp. 3-4; 0329, p. 3; 0369, Att. 2, pp. 2-3). For example, the Vinyl
Institute found the proposed text ``is ambiguous and confusing, is
provided without context, appears to be inconsistent with accepted
scientific practice and OSHA guidance, and may conflict with the
existing HCS classification for flammable solids'' (Document ID 0369,
p. 2).
Several commenters stated that they or their member companies are
accustomed to relying on National Fire Protection Association (NFPA)
standards to provide a clear and well-defined definition of combustible
dust, including testing procedures, and would prefer for OSHA to adopt
or align with NFPA's definition. PLASTICS stated that OSHA has, in the
past, referenced NFPA standards that define combustible dust as ``[a]
finely divided combustible particulate solid that presents a flash-fire
hazard or explosion hazard when suspended in air or the process-
specific oxidizing medium over a range of concentrations.'' PLASTICS
argued that this definition ``clearly state[s] it is necessary to
perform testing to determine if a material is a combustible dust and
specify the design and energy levels of the igniters to be used''
(Document ID 0314, p. 15). NACD noted that OSHA's proposed definition
is broader than the NFPA definition and that chemical distributors who
import products ``need to be able to provide their foreign suppliers
with clear parameters and test methods so they can objectively
determine whether or not their material is a combustible dust''
(Document ID 0329, p. 3). The American Forest & Paper Association
(AF&PA) and the American Wood Council (AWC) jointly submitted a comment
that their members ``have comfortably relied on the well-established,
harmonized definition of that term contained in the NFPA combustible
dust standards, which specifies the tests to be performed on the
material'' (Document ID 0287, pp. 3-4). AF&PA, AWC and PLASTICS also
commented that while the GHS references the ISO/IEC 80079-20-2 standard
for combustible dust, the GHS definition, and therefore also the
proposed HCS definition, for combustible dust are inconsistent with the
current ISO/IEC and NFPA standards (Document ID 0287, pp. 3-4; 0314,
pp. 15-16). PLASTICS further commented that the benefits of
harmonization with the GHS on the definition of combustible dust would
be limited since combustible dust is not a classified hazard in the GHS
and is only recognized under Canada's Workplace Hazardous Materials
Information System (WHMIS) (Document ID 0314, p. 16).
Several of these commenters requested that OSHA either align its
proposed definition with NFPA's definition or finalize the HCS without
adding a definition for combustible dust, effectively allowing
employers to continue using the NFPA definition (Document ID 0314, pp.
15-16; 0369, p. 3; 0287, pp. 3-4).
OSHA disagrees with commenters' suggestion to adopt the NFPA
definition in lieu of the agency's proposed definition for combustible
dust. OSHA acknowledges that the wording in the GHS is not precisely
the same as the definition in the ISO/IEC testing method consensus
standard or the NFPA definition. However, the ISO/IEC method was the
starting point for the definition in the GHS and the UN Subcommittee
modified it to ensure that it was compatible with other consensus
standards and would cover various conditions under which a dust could
deflagrate. Similarly, OSHA proposed a broad definition with the
intention of providing classifiers with a general understanding of the
intrinsic properties of the category described. This definition, along
with others in paragraph (c), is not intended to provide the detailed
descriptions and/or test methods required to classify materials, which
are instead provided through guidance materials and consensus
standards. This is consistent with other hazards included in the HCS
and GHS, for which the HCS and GHS provide a general definition and
also provide further criteria or guidance on how to determine if a
chemical exhibits this hazard.
Additionally, the NFPA definition indicates that specific tests
would be required to determine explosibility. Adopting the NFPA
definition in its entirety would be contrary to the general HCS
principle that the standard does not require the label and SDS preparer
to conduct testing. OSHA is aware that NFPA standards address
combustible dust hazards in NFPA 652 as well as other NFPA consensus
standards and believes that the agency's proposed definition of
combustible dust is compatible with NFPA standards, even though it does
not replicate them. Classifiers can therefore continue to rely on the
NFPA standards to determine whether a material is a combustible dust.
Several stakeholders also provided comments on specific terms used
in OSHA's proposed definition which differ from the terms used by NFPA.
AF&PA and AWC commented that ``catch fire'' is undefined and could be
conflated with ``ignition'' (Document ID 0287, pp. 3-4). PLASTICS also
stated that OSHA's phrase ``catch fire'' is unclear, in part because it
suggests that ignition energy levels are irrelevant, whereas NFPA
standards use and define the term ``flash-fire'' instead (Document ID
0314, pp. 15-16). The Vinyl Institute commented that ``catch fire''
could be interpreted as meaning ignition or resulting in a self-
sustaining propagation, which could be confused with flammable solid
(Document ID 0369, Att. 2, pp. 2-3). USBSA et al. similarly commented
that the use of the phrase ``catch fire'' in OSHA's definition of
combustible dust would cause an overlap between the proposed category
of combustible dust and the existing category of flammable solids
(Category B.7 in Appendix B). As a result of this overlap, a substance
might be classified as a combustible dust because of a flammability
hazard (rather than because of an explosion hazard) and also classified
as a flammable solid for the same reason (Document ID 0325, pp. 3-4;
0425, Tr. 15). USBSA et al. concluded that OSHA should adopt criteria
that permit manufacturers to distinguish between the categories of
``combustible dust'' and ``flammable solids'' (Document ID 0325, p. 4).
OSHA agrees with the comments that the phrase ``catch fire'' is
insufficiently clear. Accordingly, OSHA has eliminated the phrases
``are liable to catch fire'' and ``on ignition'' and replaced ``catch
fire'' with ``pose a flash-fire hazard,'' similar to NFPA standards 652
and 654 (Document ID 0433; 0457). However, OSHA disagrees that the
definition will cause confusion between the category of combustible
dust and the
separate category of flammable solids, which have very specific
classification criteria and clear test methods for determining
flammability. To the extent that there is overlap between the
classifications, this is because flammable solids are one type of
combustible dust. Even so, it is important to identify both hazards
because they can occur under different conditions. For further
discussion on flammable solids, please see the Summary and Explanation
for Appendix B.7.
USBSA et al. also commented on the word ``explode,'' stating that
it ``is inaccurate and misleading'' (Document ID 0325, p. 4). USBSA et
al. noted that, of the elements needed for an explosion (fuel, ignition
source, oxygen, dispersion of dust particles in sufficient quantity and
concentration, and confinement of the dust cloud), several were missing
from the proposed definition. USBSA et al. stated that without
confinement as a criterion, the proper term is ``deflagrate'' instead
of ``explode.'' USBSA et al. went on to state that OSHA should include
the NFPA confinement and particle size criteria of less than 500
microns in the HCS definition of combustible dust (Document ID 0325,
pp. 4-6; 0425, Tr. 15-17).
OSHA agrees that ``explode'' was not sufficiently clear in the
proposed definition. In order to provide clarity and consistency with
the NFPA definition of combustible dust, as commenters requested, OSHA
has replaced the term ``explode'' with ``explosion hazard'' which
refers to when solid particulates are dispersed in air or an oxidizing
media. It is the oxidizing media that is especially important for the
explosion hazard to be present (Document ID 0433; 0457). Additionally,
deflagration is a type of explosion hazard, as indicated by the NFPA
definition of explosion hazard, and therefore OSHA believes that it is
more appropriate to use the broader term ``explosion hazard'' here,
rather than USBSA et al.'s suggested ``deflagration.'' Also, to be
consistent with the NFPA definition and the term ``explosion hazard''
OSHA is making a corresponding change of the term ``particle'' to
``particulate'' in the HCS definition of combustible dust.
OSHA disagrees, however, with USBSA et al.'s suggestion to include
criteria for confinement and particle size because these criteria are
not appropriate to OSHA's purpose in providing the definition of
combustible dust. While OSHA agrees that certain conditions must apply
before a combustible dust explosion can occur, OSHA does not believe
the confinement and particle size criteria should be part of the HCS
definition, which OSHA has written to include intrinsic properties of
combustible dusts but not the conditions required for their ignition.
OSHA has taken a similar approach to defining other physical hazards in
the HCS. For example, the definition of flammable liquids (Appendix
B.6) includes the flash point, which is an intrinsic property of a
material. For a flammable liquid to ignite, several conditions, such as
vapor layer and source of ignition, are needed, but these are not
properties of the material that render it intrinsically flammable and
are therefore excluded from OSHA's definition. Such conditions are
important to evaluating the risk of ignition in handling and use, but
not to identifying whether a liquid is itself flammable. Similarly, in
the case of combustible dust, confinement is a condition wholly
external to the material itself, and the particle size of the material
does not determine whether it can ignite (even though it is relevant,
together with other factors including the confinement area, to the
likelihood of ignition). Therefore, OSHA has chosen not to add
confinement and particle size to the HCS definition of combustible
dust.
ACC recommended that OSHA place ``measurable parameters around the
definition or specify that it is ideally meant for organic and metal
dusts'' (Document ID 0347, p. 26). OSHA has determined that it is
neither necessary to add more specific parameters to the definition of
combustible dust nor helpful to limit it as ACC proposes. OSHA and NFPA
have both provided guidance documents that outline how to determine if
a dust is combustible as well as lists of materials that are commonly
considered combustible. Moreover, combustible dust hazards are not
limited to organic and metal dusts, so to limit the definition as ACC
suggests would potentially result in some chemicals that pose
combustible dust hazards not being labeled as such.
Dow commented that the agency should make a clear distinction
between the definition of combustible dust and the phrase ``explosible
dust'' as it is used in Appendix C.4.31 (Document ID 0359, p. 5). OSHA
intends these terms to be interchangeable and uses both terms in its
own guidance products. For further discussion on this issue please see
the Summary and Explanation for Appendix C.4.31.
USBSA et al. also asked OSHA to clarify that the definition of
combustible dust is for hazard communication purposes only and is not
for other regulatory purposes. As OSHA stated earlier, the proposed
definition is sufficiently broad to be consistent with uses of the term
in other standards (86 FR 9696) and would not be the primary source for
interpreting those existing standards when the agency has guidance
specific to those standards.
The Edison Electric Institute (EEI) asked OSHA to include a
statement addressed to its compliance officers in the preamble of this
rule acknowledging that a product labeled as posing a combustible dust
hazard may not necessarily be combustible in a particular workplace
(Document ID 0360, pp. 7-8). As EEI points out, OSHA has repeatedly
stated that the determination of a hazard for classification purposes
does not necessarily indicate risk in any particular workplace.
However, OSHA addresses compliance issues and instructions to its
compliance officers in other documents and therefore will not use the
preamble of this rule to address this issue.
For the reasons discussed above, OSHA is finalizing the definition
of combustible dust as proposed with the following modifications: the
phrases ``liable to catch fire'' and ``ignition'' are replaced with
``pose a flash-fire hazard''; the term ``explode'' is replaced with
``explosion hazard''; and the term ``particles'' is changed to
``particulates.'' The final version defines combustible dust as
``finely divided solid particulates of a substance or mixture that pose
a flash-fire hazard or explosion hazard when dispersed in air or other
oxidizing media.'' While these modifications represent departures from
the GHS definition, the agency believes the definition as finalized
best effectuates the purpose of the HCS by remaining consistent with
the intent of the GHS definition while addressing the Vinyl Institute
and others' concerns, discussed above, that OSHA's original definition
was confusing, ambiguous, and overly broad (Document ID 0287, pp. 2-4;
0325, pp. 3-4; 0329, p. 3; 0369, Att. 2, pp. 2-3).
Exposure or exposed. OSHA proposed revising the definition of
exposure or exposed. The definition in the 2012 HCS provided, in
relevant part, that exposure or exposed means that an employee is
subjected in the course of employment to a chemical that is a physical
or health hazard. In the NPRM, OSHA proposed revising the definition to
mean that an employee is subjected in the course of employment to a
``hazardous chemical,'' rather than to ``a chemical that is a physical
or health hazard,'' to clarify that the HCS covers the hazards of all
hazardous chemicals,
including those considered to be HNOCs. OSHA received no comments on
this proposed revision, and is therefore finalizing the definition of
exposure or exposed as proposed.
Gas, liquid, and solid. OSHA proposed to include three new
definitions for the terms gas, liquid, and solid. The agency proposed
including these terms to align with Rev. 7 (Document ID 0060). Although
not included in the GHS definitions of these terms, OSHA also proposed
adding the temperature in equivalent degrees Fahrenheit and pressure in
equivalent pounds per square inch (PSI) to the new HCS definitions of
gas and liquid because those measurements are more commonly used in the
U.S.
OSHA proposed defining gas and liquid to be consistent with Rev. 7.
Furthermore, in accordance with Rev. 7, OSHA proposed including, as
part of the definition of liquid, that a viscous substance or mixture
for which a specific melting point could not be determined ``shall be
subjected to ASTM 4359-90 . . . or to the test for determining fluidity
(penetrometer test) prescribed in section 2.3.4 of Annex A of the
European Agreement concerning the International Carriage of Dangerous
Goods by Road (ADR) . . .'' Finally, OSHA proposed adopting the GHS
definition of solid as a substance or mixture not meeting the
definitions of liquid or gas.
The agency proposed to include these definitions to improve clarity
and ensure consistency in hazard communication and classification both
domestically and internationally. The agency believes that defining
these terms in the standard will clarify provisions under Appendices B
and D for classification of hazardous chemicals and preparation of
SDSs. OSHA indicated in the proposal that it did not anticipate that
these new definitions would impact other existing standards for
construction or general industry. OSHA requested comments on its
proposal to include these definitions in this update.
OSHA received multiple comments on the specific proposed
definitions for gas, liquid and solid. NIOSH supported the definitions,
indicating that aligning with the GHS definitions would provide
transparent, consistent, and clear language that is universally
understood and would facilitate hazard communication and inform risk
management decisions across multiple scenarios (Document ID 0456, Att.
2, p. 2). API, Michele Sullivan, and DGAC also supported aligning the
definitions with the GHS (Document ID 0316, p. 2; 0339, p. 1; 0366, p.
2; 0423, Tr. 62). Ameren supported the new definitions and noted that
OSHA should consistently implement these and other definitions in the
NPRM in all affected OSHA standards (Document ID 0309, p. 15). OSHA
discusses the impact of this final rule on other OSHA standards further
below.
Since no commenters objected to the proposed definition of gas,
OSHA is finalizing it as proposed.
OSHA received two comments that were critical of the definition of
liquid. Specifically, PLASTICS and Toby Threet both commented that the
phrase ``shall be subjected to'' in the proposed definition seemed to
indicate OSHA was requiring testing even though the HCS has never
required testing to comply with the standard (Document ID 0314, p. 16;
0279, p. 14).
OSHA agrees with these commenters that the proposed language
implies a testing requirement and needs clarification. Since it was
first promulgated in 1983, the HCS has required that manufacturers,
importers, distributors, and employers evaluate the chemical hazards in
the workplace and communicate those hazards to workers, but has not
required testing in order to meet the provisions of the standard (48 FR
53280, 53290). The HCS specifies in paragraph (d)(2) that there is no
requirement to test a chemical for hazard classification purposes.
Moreover, the GHS specifically states, in Chapter 1.3.2.4.1, that it
``does not include requirements for testing substances or mixtures''
(Document ID 0060, p. 19).
To clarify OSHA's intention on testing for this provision, Threet
recommended removing the phrase ``shall be subjected to'' from the
definition and to state instead that either of the cited testing
methods ``can establish whether a viscous substance or mixture is a
liquid if a specific melting point cannot be determined'' (Document ID
0279, p. 14). OSHA agrees that these revisions are more consistent with
the agency's intent and is amending the definition of liquid to include
these revisions. Additionally, OSHA did not provide the PSI conversion
for the first time the value 101.3 kPa is used. OSHA is inserting 14.69
PSI with 101.3 kPa in parentheses in the midsection of the definition
so that it reads: ``. . . which is not completely gaseous at 68 [deg]F
(20 [deg]C) and at a standard pressure of 14.69 PSI (101.3 kPa) . . .''
Accordingly, this final rule defines a liquid as shown in the
amendatory text of this final rule.
Finally, OSHA received one additional comment on the definition of
solid beyond the supportive comments noted above. PLASTICS suggested
revising the proposed definition to recognize plasma as an additional
state of matter. PLASTICS noted that plasma is ``a generally accepted
state of matter generated in certain lighting and has both cutting and
arc welding applications'' (Document ID 0314, pp. 16-17).
OSHA does not believe that revising the proposed definition of
solid would serve OSHA's purpose in adding the term, which was to
clarify the HCS and align with the GHS (86 FR 9697). The GHS and the
HCS do not define or use the term plasma. The terms in paragraph (c)
include those that are relevant to the GHS and the HCS, are needed for
comprehension of provisions within the standard, and improve global
harmonization (77 FR 17697). Since the term plasma is not defined in
the GHS, is not referenced in the GHS definitions of gas, liquid, or
solid, and is not related to any physical hazard covered under the HCS,
the agency declines to revise the proposed definition of solid to
recognize plasma as a state of matter. OSHA notes that, insofar as the
physical properties of the material noted by PLASTICS as ``plasma'' in
lighting, cutting, and arc welding meet the criteria of one of these
definitions, they would be covered under the relevant hazard classes.
For the reasons discussed above, OSHA is finalizing the definitions
of gas and solid as proposed and is revising the term liquid to
incorporate the changes suggested by commenters.
Hazardous chemical. OSHA proposed updating the definition of
hazardous chemical to delete a reference to pyrophoric gas because OSHA
proposed classifying pyrophoric gas as a physical hazard in the
flammable gas hazard class (see discussion in the Summary and
Explanation for Appendix B.2). OSHA received one comment, from Ameren,
stating that the revised definition is acceptable (Document ID 0309, p.
15). No commenter opposed the revision. The agency is therefore
finalizing the definition of hazardous chemical as proposed.
Immediate outer package. OSHA proposed to add a definition for
immediate outer package. In this final rule, paragraph (f)(12)
(discussed in more detail in the Summary and Explanation for paragraph
(f)) relaxes labeling requirements for small containers, but still
requires complete label information on the immediate outer package. For
example, in the case of a kit, the container would be whatever
surrounds the chemical itself (e.g., a vial), and the immediate outer
package would be the first box or package surrounding the container.
OSHA received several comments in support of the proposed
definition. Both Ameren and SAAMI supported the definition as proposed
and SAAMI commended the agency for providing better harmonization with
DOT (Document ID 0309, p. 15; 0294, p. 3; 0412, p. 2). DGAC supported
the proposed definition as it provides clarity to the regulation and
should enhance compliance with the standard (Document ID 0339, p. 1).
No commenter opposed the proposed definition. OSHA is therefore
finalizing the definition of immediate outer package as proposed.
Physical hazard. OSHA proposed to update the definition of physical
hazard. The proposed definition also explicitly stated that ``[t]he
criteria for determining whether a chemical is classified as a physical
hazard are detailed in Appendix B''. The proposal included two
substantive changes to the previous definition: (1) it moved the
reference to aerosols out of the parenthetical following the word
``flammable''; and (2) it added a reference to desensitized explosives.
These proposed revisions reflect the new hazard classes proposed for
aerosols and desensitized explosives in Appendix B to align with Rev. 7
(see the Summary and Explanation for Appendix B). OSHA received one
comment, from Ameren, indicating the revised definition is acceptable
(Document ID 0309, p. 15). No commenter opposed the revised definition.
Therefore OSHA is finalizing the definition of physical hazard as
proposed with two minor technical amendments: OSHA is changing the
contents of the parentheticals following ``flammable'' and
``oxidizers'' to read ``. . . flammable (gases, liquids, or solids) . .
.'' and ``. . . oxidizers (gases, liquids, or solids) . . .'' for
grammatical consistency with each other.
Physician or other licensed health care professional (PLHCP). OSHA
proposed adding a definition of physician or other licensed health care
professional (PLHCP) to the standard. The new definition is necessary
in light of OSHA's proposal to replace the phrase ``physician and
nurse'' in paragraph (i) with the term PLHCP to be consistent with
other OSHA standards that use the term PLHCP and to better reflect
current medical practices. That change is also discussed in the Summary
and Explanation for paragraph (i). The proposed definition of PLHCP is
consistent with the way the agency has defined that term in all health
standards promulgated since the bloodborne pathogen standard, 29 CFR
1910.1030, in 1991. One commenter, Ameren, indicated that the
definition is appropriate because it is already used in other OSHA
standards and reduces confusion with other OSHA standards (Document ID
0309, p. 15). No commenter opposed the proposed definition. OSHA is
therefore finalizing the definition of physician or other licensed
health care professional (PLHCP) as proposed.
Pyrophoric gas. OSHA proposed deleting the definition for
pyrophoric gas from paragraph (c) in conjunction with its proposals to
delete the reference to pyrophoric gas from the HCS definition of
hazardous chemical and add the definition of pyrophoric gas to Appendix
B.2, discussed earlier in this section of the Summary and Explanation.
OSHA received one comment from Ameren indicating the change was
acceptable (Document ID 0309, p. 15). No commenter opposed the change.
OSHA is therefore deleting the definition of pyrophoric gas from
paragraph (c).
Released for shipment. OSHA proposed to add a new definition,
released for shipment, to mean ``a chemical that has been packaged and
labeled in the manner in which it will be distributed or sold.'' This
is a new term OSHA proposed for use in paragraphs (f)(1) and (f)(11)
related to updating labels when new hazard information becomes
available. This definition is similar, but not identical to, the
definition used by the EPA's Pesticide Registration and Classification
Procedures regulation, 40 CFR 152.3. EPA defines a product as released
for shipment ``when the producer has packaged and labeled it in the
manner in which it will be distributed or sold, or has stored it in an
area where finished products are ordinarily held for shipment.'' OSHA
did not propose to include chemicals that are stored in an area where
finished products are usually held but have not been packaged and
labeled in the HCS definition of released for shipment because there do
not appear to be any feasibility issues with ensuring that such
chemicals are labeled with the most updated information. The agency
requested comments on whether the proposed definition is appropriate
for application to the HCS. In addition, OSHA was interested in
understanding whether the slight differences between OSHA's and EPA's
definitions would pose any compliance issues for entities dealing with
both OSHA and EPA labeling requirements.
OSHA received several comments on the proposed definition of
released for shipment. SOCMA supported the proposed definition
(Document ID 0447, p. 3). The Vinyl Institute also supported the
definition, commenting that it reflects the realities of manufacturing
operations by recognizing the occurrence of delayed or returned
manufactured shipments (Document ID 0369, Att. 2, pp. 8-9).
A few other commenters were concerned that the proposed definition
would cause confusion. Tom Murphy commented that workers may
misunderstand the intention of the proposed definition; for example,
the proposed language could be interpreted by workers as meaning
products that had passed quality control testing, were correctly
packaged for shipment, were ``approved for presentation to the
customers,'' and were ready to move into inventory (Document ID 0277,
p. 2). Murphy suggested that ``packaged for shipment'' may be a better
term and would reduce misinterpretation by workers (Document ID 0277,
p. 2). ACC similarly commented that released for shipment might be
misunderstood to mean that the package ``has met the business need or
logistics criteria'' and is ready for shipment, and suggested that OSHA
adopt ``packaged for shipment'' or ``labeled for shipment'' instead
(Document ID 0347, p. 9).
NACD recommended that OSHA reconsider including this definition,
which they commented could create confusion and uncertainty as to
whether the label must state ``released for shipment.'' Similar to
other commenters, NACD noted that many products may be packaged and
labeled but are still awaiting a final quality control check, third-
party testing, or customer approval (Document ID 0329, p. 3; 0465, p.
3).
OSHA has decided not to adopt these suggestions for several
reasons. First, the suggested changes would misalign the agency and
EPA's terms. Specifically, under EPA's regulation, released for
shipment is defined as product or stock that is packaged and labeled in
a manner in which it will be distributed or sold, and the producer or
distributor must provide the pesticide label to the receiver before or
at the time of distribution (40 CFR part 152.3). Many of the regulated
entities who are affected by OSHA's proposal to add a definition of
released for shipment are also required to comply with EPA's
regulations, and OSHA does not want to cause confusion for parties who
must comply with both, so OSHA finds that the proposed changes are not
necessary and would be contrary to OSHA's purpose for including this
definition.
Moreover, OSHA disagrees that the definition will result in
confusion. In response to NACD's comments, OSHA
does not intend for the manufacturer, importer, or distributor to
include the phrase ``released for shipment'' on the label. The
definition is only provided in paragraph (c) to help classifiers and
other stakeholders understand the meaning of paragraph (f)(11).
Furthermore, as is discussed in the Summary and Explanation for
paragraphs (f)(1) and (f)(11), OSHA is eliminating the proposed
requirement for the released for shipment date to be included on the
label. Therefore, it is unnecessary for manufacturers to use the date
of manufacture as a stand in for that term, as suggested by NACD. OSHA
believes this clarification that the phrase ``released for shipment''
is not intended to be printed on the label (or anywhere on the package)
may also relieve commenters' concerns that the phrase ``released for
shipment'' will be confused with readiness for shipment in a business
or logistical sense by individuals working in facilities where packages
are stored for shipment.
Toby Threet commented that the ``date of labeling and the date of
release for shipment are the same thing, under OSHA's definition''
(Document ID 0279, p. 15). Since the agency is eliminating the proposed
requirement to include the released for shipment date on the label, no
such confusion should arise from the definition that OSHA proposed for
released for shipment.
After considering the comments and testimony submitted, OSHA has
determined that the definition for released for shipment should be
retained in the final rule and should use the term ``released'' in
order to align with EPA's definition of released for shipment in its
Pesticide Registration and Classification Procedures regulation, 40 CFR
152.3. Therefore, OSHA is finalizing the definition of released for
shipment as proposed.
OSHA also received a few comments not related to any specific
proposed definition. API commented that in general ``any definitions
used should align with the GHS'' (Document ID 0316, p. 2). API stated
that if a GHS definition is not available then the term should not be
used. Alternatively, they suggested that if OSHA uses a term that is
not taken directly from the GHS, then OSHA should ``be transparent that
the definition has not yet been harmonized in GHS and could change once
harmonized'' (Document ID 0316, p. 2). OSHA disagrees that only terms
from the GHS should be used in the HCS. The OSHA HCS regulatory
framework existed well before the GHS. While OSHA has aligned with the
hazard classes of the GHS and most provisions in the annexes of the GHS
that apply to occupational situations, the HCS includes additional
provisions to inform and protect workers while providing a consistent
framework for businesses regulated under the HCS. In addition, OSHA has
been clear in both the NPRM and this final rule about the extent to
which each definition aligns with the GHS.
OSHA also received a comment from PRINTING United Alliance
(PRINTING) requesting the addition of a definition for ``injurious
corrosive material'' (Document ID 0357, pp. 4-5). This is a term that
appears in OSHA's Medical Services and First Aid standard at 29 CFR
1910.151(c), not in the HCS. PRINTING expressed difficulty ascertaining
which chemicals are ``injurious corrosive materials'' that require
provision of eye wash or flushing stations pursuant to 29 CFR
1910.151(c) and asked OSHA to add a definition to the HCS similar to
that used by Michigan Occupational Safety & Health Administration
(MIOSHA) in a guidance document related to eyewash facilities (Document
ID 0357, pp. 4-5). However, the HCS is not an appropriate location for
a definition of ``injurious corrosive material'' because that term is
not used in the HCS. Therefore, the agency will not be including this
definition in the update to the HCS.
OSHA also received a comment from IMA-NA stating that OSHA should
``align any definition of nanomaterials in the HCS to the EPA's
definition'' (Document ID 0363, pp. 5-6). While OSHA has addressed
particle characteristics, including particle size, in the context of
Section 9 of the SDS in Appendix D (see Summary and Explanation for
Appendix D), the agency has not proposed to add a definition of
nanomaterials to the HCS and finds this comment to be outside the scope
of this rulemaking.
Finally, as indicated above, OSHA received one general comment on
the potential impact of several of the new or revised definitions on
other standards. While Ameren commented that the definitions are
generally acceptable, they also commented that they believed these new
and revised definitions would impact other OSHA standards, contrary to
OSHA's assertion, and that OSHA needed to ensure that for several of
the new and revised definitions they were consistently implemented in
other OSHA standards. Specifically, they cited potential impacts on 29
CFR 1910.120, Hazardous waste operations and emergency response, and 29
CFR 1926.1101, Asbestos. However, Ameren did not provide any specifics
as to how these two standards might be impacted.
Many of the terms that OSHA is adding or updating in this final
rule are not used in the standards referenced by Ameren. Of the terms
Ameren cited, only gas and liquid are used in 29 CFR 1910.120 and 29
CFR 1926.1101. In both standards, the terms are used in a very
different way in contexts that make clear what is meant by the term gas
or liquid. For instance, the term gas is used to modify the word meter
(1910.120 (c)(6)(ii)) and used in reference to gas leakage in chemical
protective suits (1910.120 (g)(4)(iii)). OSHA is not convinced that
there will be any confusion on what is meant by the terms gas or liquid
in these cases.
As stated above in the discussion under the combustible dust
definition, while OSHA indicated in the proposal that it did not
anticipate that these new definitions would conflict with or otherwise
impact other existing standards for construction or general industry,
the agency notes that where the same term is used but not defined in
another standard, and where OSHA has guidance specific to that
standard, that guidance, rather than the HCS definition, is the
relevant interpretive source.
(d) Hazard Classification
Paragraph (d)(1) of the HCS outlines the requirements for chemical
manufacturers and importers to evaluate the hazards of chemicals that
are in the workplace or being imported to determine the hazard classes,
and where appropriate, the category of each class that apply to the
chemical being classified.
In the NPRM, OSHA proposed two changes to paragraph (d)(1). OSHA
proposed to revise the second sentence of paragraph (d)(1) to read that
for each chemical, the chemical manufacturer or importer shall
determine the hazard classes, and where appropriate, the category of
each class that apply to the chemical being classified under normal
conditions of use and foreseeable emergencies (emphasis added to
indicate the proposed new language). The intent of the language that
OSHA proposed was to simply reiterate the scope language currently in
paragraph (b)(2) and OSHA's longstanding position that hazard
classification must cover hazards associated with normal conditions of
use and foreseeable emergencies. As OSHA explained in its compliance
directive for the HCS (Document ID 0007), for example, known
intermediates, by-products, and decomposition products that are
produced during normal conditions of use or in foreseeable emergencies
must be addressed in the hazard
classification. OSHA also proposed to add a new sentence to paragraph
(d)(1) stating that the hazard classification shall include any hazards
associated with a change in the chemical's physical form or resulting
from a reaction with other chemicals under normal conditions of use.
OSHA believed adding this language to be necessary because there
had been some confusion about whether chemical reactions that occur
during normal conditions of use must be considered during
classification and whether this information should be placed on the
label and/or the SDS. This issue has arisen, for instance, when
multiple chemicals are sold together with the intention that they be
mixed together before use. For example, epoxy syringes contain two
individual chemicals in separate sides of the syringe that are mixed
under normal conditions of use. The intent of this proposed new
language was to ensure that manufacturers and importers understood what
information should be on the label (hazards associated with the
chemical as shipped, including changes in physical form) versus what
belonged on the SDS (all hazard information including information on
hazards created through downstream use), and OSHA accordingly proposed
a change in paragraph (f)(1) as well to reflect the new language in
(d)(1). In addition, the proposed new language better aligns with
international trading partners' label requirements under REACH and
WHMIS and provides consistency on where this information is located so
workers can easily find the information.
OSHA received several comments agreeing on the need for
clarification about the requirements related to classification of
hazards resulting from downstream uses. NABTU agreed that OSHA's
clarification on the hazards covered under (d)(1) would help workers
find information more quickly and minimize mistakes, as well as aid in
training, because it would improve consistency in the location of
information (Document ID 0425, Tr. 37). Additionally, NABTU provided
several examples where hazards created by chemical reactions as part of
the intended use of the product were not being conveyed consistently
and, in some cases, not at all (see, e.g., Document ID 0450, Att. 2, p.
5). NABTU provided safety data sheets for spray foams, epoxies, and
cement where a chemical reaction occurs in downstream workplaces
following the manufacturer's instructions. The information on the SDSs
for these chemicals does not differentiate the hazards of the original
chemical versus the hazards the worker might be exposed to through
prescribed use of the product (see, e.g., Document ID 0450, Att. 2, p.
5). Additionally, California's Department of Industrial Relations,
Division of Occupational Safety and Health (Cal/OSHA) provided the
example of a hair smoothing product used in professional hair salons
where the intended use of the product created different hazards due to
chemical reactions (formation of formaldehyde during use which caused
various adverse health effects) than the hazards associated with the
original chemical. In this case, these hazards were not identified on
either the label or the SDS (Document ID 0451, pp. 3-4). Without this
information, downstream users are unaware of the potential exposures
and therefore do not have the information necessary to adequately
protect themselves. NIOSH also supported the change and said that it
would be helpful for worker safety and health (Document ID 0281, Att.1,
p. 6).
However, OSHA also received numerous comments indicating that
OSHA's proposed language could be misunderstood and cause confusion on
what would be required under paragraph (d)(1). Many of these commenters
opposed inclusion of the proposed language as written. Based on the
comments received, as explained further below, OSHA is modifying the
proposed language to more clearly articulate OSHA's intent for the
scope of this requirement as well as to better distinguish between
hazards associated with the chemical as shipped and hazards associated
with downstream use. Specifically, OSHA is deleting the phrase ``under
normal conditions of use and foreseeable emergencies.'' The agency is
adding at the end of (d)(1) the phrase ``The hazard classification
shall include any hazards associated with the chemical's intrinsic
properties including:'' and then adding two subparagraphs, (d)(1)(i)
and (d)(1)(ii).\56\ New paragraph (d)(1)(i) reads, ``a change in the
chemical's physical form and;'' and new paragraph (d)(1)(ii) reads,
``chemical reaction products associated with known or reasonably
anticipated uses or applications.'' OSHA is also changing the language
in paragraph (f)(1) to clarify that hazards identified and classified
under new paragraph (d)(1)(ii) will not be required to appear on a
product's label (see the Summary and Explanation for paragraph (f)(1)).
Changes in Appendix D clarify that hazards identified and classified
under both paragraphs (d)(1)(i) and (d)(1)(ii) must be included in
Section 2 of the product's SDS. As stated above, OSHA considers the
language, as finalized, to be a rephrasing of the language proposed in
the NPRM to more clearly articulate OSHA's intent and not a substantive
change from what OSHA originally intended in the NPRM or the
preexisting requirement to incorporate downstream uses. The rest of the
section therefore still relies on previous guidance and statements OSHA
made regarding ``normal conditions of use and foreseeable emergencies''
to support the language OSHA is finalizing in this rule.
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\56\ Throughout this section and in the regulatory text, OSHA
refers to the ``intrinsic'' properties of chemicals. OSHA considers
this to be synonymous with ``inherent'' properties, a term used by
some commenters and in the original HCS.
---------------------------------------------------------------------------
In the following discussion, OSHA addresses the comments received
on paragraph (d)(1), separated by theme.
I. Arguments That the HCS Has Historically Not Required Manufacturers
To Classify Chemicals Due to Hazards Related to Downstream Use
Several stakeholders commented that the HCS historically has not
required manufacturers to classify hazards based on downstream
reactions (Document ID 0318, pp. 3-4; 0325, pp. 7-15; 0326, p. 3; 0337,
p. 2; 0314, pp. 4-5; 0348, p. 2; 0356, p. 7; 0369, p. 4). For example,
ACC stated, ``[n]ot only is OSHA's approach incompatible with the
current language of the HCS, it is not supported in the text or
regulatory history of the HCS'' (Document ID 0347, p. 3). ACC quoted
OSHA's preamble from the 2012 update, where OSHA stated that
manufacturers and importers have greater knowledge and expertise with
regards to the composition of the chemicals they make or import than do
downstream employers and are usually in the best position to assess the
intrinsic hazards associated with them, whereas downstream employers
are usually in the best position to determine the risk arising from the
use of the chemical in their workplaces (Document ID 0347, p. 3). ACC
also quoted OSHA's compliance directive, where OSHA acknowledges that
downstream users who alter the product become the manufacturer and
become the responsible party, so would need to consider all the known
or intended uses of the products when classifying for hazards. ACC
commented that OSHA has not identified any guidance documents that
would support the agency's interpretation of (d)(1) (Document ID 0347,
pp. 2-3). Additionally, PLASTICS indicated that OSHA has not
historically required manufacturers to classify the hazards of by-
products produced during
downstream use of a chemical. PLASTICS provided several examples dating
back to 2004 indicating that OSHA did not intend to have the byproducts
included in the hazard determination process or that the downstream
employer was responsible for the hazard determination process for
byproducts. PLASTICS also indicated that OSHA has been unclear and that
various guidance documents have appeared to be inconsistent in their
discussion of the scope of the hazard classification process (Document
ID 0314, Att. 1, pp. 4-9).
NAIMA suggested that OSHA should address the hazard classification
revision in a separate rulemaking, and request information from the
regulated community. NAIMA viewed the proposed changes as OSHA's
attempt to impose new burdens and regulatory changes in the guise of
harmonizing the HCS with the GHS (Document ID 0338, p. 9).
OSHA disagrees that the HCS has not historically required
manufacturers to identify hazards related to downstream uses of the
chemical they produce or provided any guidance to this effect. While
ACC is correct that OSHA, in the preamble to the 2012 HCS,
distinguished between the relative knowledge of manufacturers and
downstream employers, ACC neglected to include in their comment the
paragraph immediately following the one it quoted. That paragraph
states: ``OSHA's approach in promulgating the HCS reflects this
reality. It places the duty to ascertain and disclose chemical hazards
on manufacturers and importers, so that downstream users can use this
information to avoid harmful exposures to chemical hazards. But because
manufacturers and importers will often have less information about the
particular exposures of downstream users, their hazard assessment and
communication obligations are imposed only for all normal conditions of
use of their chemicals and foreseeable emergencies associated with
those chemicals'' (emphasis added) (77 FR 17601-02). Additionally,
during the 2012 rulemaking, in paragraph (a)(1) OSHA changed the
language to specify that the purpose of the HCS is to ensure
classification of hazards, rather than merely assessment or evaluation
of them, further indicating that the language in the scope section
regarding normal conditions of use and foreseeable emergencies was
intended to apply to the classification process, not just assessment of
hazards more broadly (77 FR 17693). Thus, the 2012 HCS did, in fact,
contemplate that manufacturers would classify their chemicals for
hazards associated with these types of downstream uses.
This concept has been part of the HCS since the beginning. As
indicated in the preamble to the 1983 HCS, stakeholders raised concerns
then regarding responsibility for providing information on MSDSs (now
referred to as SDSs) that only the downstream employer could know. In
response, OSHA agreed that ``[t]he chemical manufacturer or importer,
in making hazard determinations, should evaluate and communicate
information concerning all the potential hazards associated with a
chemical, whereas the employer may supplement this information by
instructing employees on the specific nature and degree of hazard they
are likely to encounter in their particular exposure situations'' (48
FR 53296). The preamble of the 1983 HCS went on to explicitly state
``[t]herefore, the chemical manufacturer must provide thorough hazard
information, which would be applicable to a full range of reasonably
foreseeable exposure situations, rather than limiting the information
on the basis of presumed use. The downstream employer will then be
assured of having the information reasonably necessary to make informed
choices for control measures'' (48 FR 53307). When OSHA updated the HCS
in 2012, it replaced the hazard determination process with the hazard
classification process and indicated that hazard classification was
``very similar to the process of hazard determination that is currently
in the HCS, with the exception of determining the degree of hazard
where appropriate'' (58 FR 17698).
Another example of OSHA's longstanding view that manufacturers must
consider downstream hazards is found in a 1994 LOI regarding normal
conditions of use for wood products. The LOI stated that wood and wood
products are exempt from the hazard communication standard as articles
``if the only hazard presented from use of the product is flammability
or combustibility, which are hazards that are well-known among users of
wood products. However, it may not be generally known among users that
inhalation of certain types of wood dust or chemicals used to treat
wood can present a serious lung disease hazard. For this reason, OSHA
has always required under the hazard communication standard that
distributors of wood products provide MSDS to employers whose employees
may be exposed to these inhalation hazards'' (available at https://www.osha.gov/laws-regs/standardinterpretations/1994-12-05). As in 1994,
OSHA does not intend that every possible downstream use be accounted
for, only those that are known or can be reasonably anticipated. This
policy was reiterated in a 2016 LOI which stated that manufacturers
``must make a reasonable effort to obtain reliable information to
determine how their product(s) or by-product(s) may expose workers
under normal conditions of use or in foreseeable emergencies. A
manufacturer's or importer's hazard classification must anticipate the
full range of downstream uses of its products and account for any
hazardous by-products that are known to be present and may be formed''
(available at https://www.osha.gov/laws-regs/standardinterpretations/2016-05-20). The LOI went on to state that manufacturers are not
required to contact every downstream workplace to obtain this
information, but a reasonable effort should be made.
Finally, contrary to ACC's and PLASTICS' assertions, OSHA guidance
documents have included in the hazard determination step that ``[a]ll
possible physical or health hazards that might be associated with a
chemical's use must be considered,'' including in OSHA's 2007 Guidance
For Hazard Determination (available at https://www.osha.gov/hazcom/ghd053107). This concept was carried forward into the 2015 HCS
compliance directive which also indicates that manufacturers must
consider downstream uses of their chemicals when classifying. For
example, the directive, which provides in-depth guidance on how to
apply the criteria for classification, explains that a HNOC means an
adverse physical or health effect that is not covered under one of the
existing hazard classes in the standard. The directive then explains
that: ``The term physical effect generally refers to a material
impairment of health or functional capacity caused by the intrinsic
hazard(s) of a particular chemical in normal conditions of use or
foreseeable emergencies'' (Document ID 0007, pp. 19-20). These
statements in combination make clear that OSHA expected the hazards of
downstream uses to be accounted for in the classification process.
Additionally, what PLASTICS identified as inconsistency in OSHA's
guidance actually represents its misinterpretation of the level of
knowledge that can be expected from a manufacturer, importer, or
distributor in two different scenarios: one where the chemical in
question is used downstream to manufacture other chemicals and the
other where the chemical is used by end-users. However, the confusion
that PLASTICS
points to is exactly why OSHA has decided to clarify in this final rule
the scope of this existing obligation.
Additionally, OSHA has enforced the HCS in accordance with this
understanding of the obligations to label for downstream hazards, which
further reinforces the longstanding nature of this requirement. For
instance, in 2011 and 2012 OSHA cited a number of manufacturers under
the HCS for failing to communicate the hazards of formaldehyde exposure
to salons, stylists, and consumers using hair products containing that
chemical (see https://www.osha.gov/hair-salons/government-response).
As indicated above, OSHA has determined that the language it
originally proposed to add to paragraph (d)(1), which would have stated
that hazard classification shall include any hazards associated with a
change in the chemical's physical form or resulting from a reaction
with other chemicals under normal conditions of use, is insufficiently
precise, and is therefore adopting revised language in this final rule.
The final language provides that hazard classification ``shall include
any hazards associated with the chemical's intrinsic properties
including: (i) a change in the chemical's physical form and; (ii)
chemical reaction products associated with known or reasonably
anticipated uses or applications.'' This language in the final rule
ties a responsible party's classification obligations to what the
manufacturer, importer, or distributor knows or can reasonably
anticipate and avoids the concerns that several commenters raised that
the language was too vague (see, e.g., Document ID 0368, pp. 3-4; 0402,
p. 1; 0283, p. 13; 0461, pp. 2-3; 0315, pp. 3-4; 0313, p. 3).
Stakeholders should be familiar with the term ``reasonably
anticipated'' because OSHA has used similar language in multiple
standards, guidance products, and LOIs, including the bloodborne
pathogens standard (29 CFR 1910.1030), the respirable crystalline
silica standard (29 CFR 1910.1053), and the hazardous waste operations
and emergency response standard (29 CFR 1910.120). Moreover, this term
is commonly used by other agencies as well; for example, the National
Toxicology Program (NTP) uses ``reasonably anticipated'' as a
classification for carcinogens (reasonably anticipated to be a human
carcinogen) (86 FR 72988). EPA's TSCA regulations (40 CFR 723.250) also
use the term ``reasonably anticipated'' in their scoping language:
``Reasonably anticipated means that a knowledgeable person would expect
a given physical or chemical composition or characteristic to occur
based on such factors as the nature of the precursors used to
manufacture the polymer, the type of reaction, the type of
manufacturing process, the products produced in polymerization, the
intended uses of the substance, or associated use conditions (40 CFR
723.250).''
II. Arguments That Classification Should Be Based on Inherent or
Intrinsic Hazards
OSHA received multiple comments from a variety of stakeholders
stating that hazard classification is based on the intrinsic or
inherent properties of the chemical and the proposed changes in
paragraph (d)(1) go beyond the meaning of intrinsic or inherent
properties (Document ID 0303, p. 1; 0347, pp. 2-3; 0322, p. 14; 0424,
Tr. 116, 117, 138, 195, 205; 0366, p. 3; 0323, pp. 2-5; 0214, pp. 1-
15).
OSHA agrees that the intention of the hazard communication standard
is to provide information based on the intrinsic or inherent hazards of
the chemical that are presented in the workplace and that are not tied
to the level of exposure to the chemical, but disagrees that the change
in paragraph (d)(1), either as proposed or as finalized here, goes
beyond the meaning of intrinsic or inherent hazards. In final paragraph
(d)(1), OSHA has made explicit that hazard classification under the HCS
should be based on the intrinsic properties of the chemical to which
workers are exposed. As finalized, paragraph (d)(1) also identifies two
examples of intrinsic properties: changes in the chemical's physical
form and chemical reaction products associated with known or reasonably
anticipated uses or applications. Label and SDS preparers must consider
both when classifying the chemicals they produce, import, or
distribute. These examples are consistent with OSHA's longstanding
interpretation of intrinsic properties or hazards.
To clarify the meaning of intrinsic hazards, OSHA provided several
examples in guidance issued in 2015 and 2016 regarding what the agency
would consider non-intrinsic hazards (Document ID 0007, p. 20; 0008, p.
385). For instance, the agency explained that hazards due to scalds
caused by exposure to chemicals at high temperatures and slips and
falls caused by treading on a solid chemical shaped in a rounded form
or spilled liquids are not physical effects caused by the chemical's
intrinsic properties under the HCS. Any substance that is heated to
high temperatures can cause a scald, and any spilled liquids could be a
slip hazard. Intrinsic hazards are hazards that are derived from the
essential nature or character of the substance, reaction product, or
mixture, which would not simply be true of any substance under those
conditions. Even prior to adopting the GHS in 2012, OSHA had identified
intrinsic hazards as the basis for identification and hazard
determination for the information on the labels, SDSs, and worker
training. OSHA is not deviating from this approach. How a chemical will
behave when its physical form changes and what chemical reaction
products form when it is used downstream are based on the properties
that are intrinsic to that chemical and would not be true of simply any
substance under those circumstances, and thus fall within OSHA's
conception of what constitutes an intrinsic hazard.
Michele Sullivan suggested that the agency should instead take a
two-pronged approach to address the issue of inherent hazards and
require (1) classification of chemicals as shipped, with hazard class
and category and (2) inclusion of hazards or warnings, rather than
classification, for chemical products with directions for downstream
use, such as kits (Document ID 0366, p. 3). OSHA does not agree with
this approach because it incorrectly applies the idea of intrinsic
hazards as a more limited concept, and the agency believes that the
language ``known or reasonably anticipated uses or applications''
cabins the breadth of the language in (d)(1)(ii) so that it is feasible
for manufacturers, importers, and distributors to classify in
accordance with the requirements.
As noted above, to address these concerns, OSHA is updating the
regulatory text to include the term ``intrinsic'' in (d)(1) to clarify
that the hazard information required is based on classification of
hazards related to the intrinsic properties of the chemicals workers
are exposed to. The agency believes that this clarifies OSHA's intent
that the hazard be of an intrinsic nature and that it considers hazards
from both changes in the chemical's physical form and chemical reaction
products associated with downstream use to be related to intrinsic
properties.
III. Arguments That the Proposed Revision to (d)(1) Would Shift the
Burden From Downstream Users to the Originating Manufacturer (or
Upstream)
Several commenters expressed concern that OSHA's proposed changes
to paragraph (d)(1) would improperly shift the responsibility for
determining and classifying chemical hazards from downstream users,
such as
manufacturers and employers that process chemicals, to the original
manufacturer of the chemical (Document ID 0314, p. 2; 0323, p. 3; 0326,
pp. 4-5; 0337, p. 2; 0347, p. 2; 0423, Tr. 134; 0348, pp. 1-2; 0404,
pp. 3-4; 0361, p. 1; 0362, pp. 2-3; 0329, p. 8; 0287, p. 6). For
example, ACMA noted that ``. . . unlike the PSM standard where the
responsibility for the analysis is properly placed on the employer
operating the covered process, OSHA's proposal would shift that
obligation upstream to each of the multiple chemical manufacturers or
importers who supplied a reactant in the downstream chemical reaction''
(Document ID 0318, p. 9). The Vinyl Institute noted that ``[a] broad
expansion of the scope of the hazard classification of the upstream
supplier to reflect the hazards of downstream chemical reactions and
the products of those reactions (including ``foreseeable emergencies'')
would be inappropriate. It would shift the responsibility from where it
belongs (on the downstream manufacturer) to an upstream supplier who
generally has not specified the chemicals to be used in the downstream
reaction, has not designed the process chemistry, has not designed the
process equipment in which the reaction occurs, has no control over the
operation of the process and has no idea what other chemicals in the
facility might be involved in what might be a foreseeable emergency
from the perspective of the downstream manufacturer-employer''
(Document ID 0369, p. 5). NACD stated that determining downstream
hazards is outside the scope of responsibilities for a distributor or
producer under the standard and that it is downstream employers who,
under the HCS, bear the responsibility to conduct hazard assessments
that apply to their own workplaces. NACD also commented that any
chemical that can be mixed with a wide range of other chemicals could
have an exponentially long and unknown list of hazards that ``result
from a chemical reaction'' and that such hazards cannot reasonably be
documented by an upstream user (Document ID 0465, p. 4). The Council of
Chemical Association Executives (CCAE) provided similar comments
(Document ID 0469, p. 2). Dow stated that the concept of classifying
reaction products is overly broad and expands OSHA's existing
requirement for manufacturers to assess chemical hazards of the product
as manufactured and shipped (Document ID 0359, p. 2).
OSHA disagrees that the proposed new language in paragraph (d)(1)
shifts any burden from the downstream user to the manufacturer. First,
as explained above, the revisions to paragraph (d)(1) clarify the
existing requirements for hazard classification and do not create new
requirements. Regardless, the intent of the new language is not to
require manufacturers, distributors, or importers to predict how
downstream employees will be exposed to a chemical or to anticipate
every conceivable way the chemical could be used, but rather to
classify the chemical for hazards that arise through known or
reasonably anticipated uses, thereby providing downstream users with
sufficient information to perform a hazard assessment specific to their
own workplace and how employees use the chemical there. As described
above, OSHA has revised the language in this final rule to better
reflect this intent. OSHA agrees that downstream users still must
assess whether the specific processes they use will cause hazards in
the workplace and is only adding this language to clarify that if the
upstream manufacturer, distributor, or importer is aware of hazardous
chemical reactions with the known or reasonably anticipated uses of its
product it must include hazard classifications for those hazards.
IV. Arguments That the Proposed Change to (d)(1) Would Be Infeasible or
Overly Burdensome to Manufacturers as It Would Require Knowledge of All
the Downstream Uses To Classify Correctly
Many comments indicated that it would be infeasible or extremely
burdensome for manufacturers, distributers, and importers of chemicals
to learn all downstream uses of products and correctly classify them
accordingly (Document ID 0291, pp. 5-6; 0303, p. 2; 0314, p. 10; 0315,
p. 3; 0316, pp. 3-4; 0317, pp. 2-3; 0318, pp. 4-5; 0319, pp. 1-2; 0323,
p. 3; 0324, p. 2; 0327, p. 7; 0347, Att. 1, pp. 2-4; 0468, pp. 1, 3;
0348, p. 2; 0356, pp. 7-9; 0357, pp. 1-3; 0359, p. 2; 0363, pp. 3-4;
0366, p. 3; 0367, p. 4; 0329, p. 2; 0369, p. 6). For example, Worksafe
stated that ``[b]oth `normal conditions of use' and `foreseeable
emergencies' are largely unknowable by producers'' (Document ID 0354,
p. 4). HCPA also stated that it is not practical to list every
potential hazard of the cleaning product which could interact with any
number of unknown soils when used by downstream consumers (Document ID
0327, pp. 7-8; 0424, Tr. 15-17).
NAIMA asserted that under the proposed new language, the upstream
chemical manufacturer or supplier would be responsible for performing a
chemical process hazard analysis and hazard classification for each
downstream chemical reaction and the reaction products of that
downstream chemical reaction conducted by a downstream customer or
manufacturer. NAIMA stated that downstream reactions typically involve
at least two chemicals, and often mixtures, that would require multiple
manufacturers' suppliers to provide redundant and overlapping chemical
process hazard analysis and hazard classification to all of these
downstream manufacturers. They also noted this same requirement would
also apply upstream to the suppliers' suppliers, and ``the real world
problem with such astounding overreach is it is unlikely that any
manufacturers will take the risk of such a convoluted and impossible
evaluation'' (Document ID 0338, p. 10).
Dow also stated that proposed changes implied that the manufacturer
and SDS preparer are responsible for knowing all foreseeable downstream
uses of the substance, including chemical reactions and resulting
chemicals generated, that could occur in the downstream supply chain
with that substance. Dow suggested that to require this level of
knowledge would present a significant compliance challenge for chemical
manufacturers because manufacturers cannot reasonably know all possible
resulting chemical reactions and uses by downstream users and the
hazards they may create. Dow further explained that the hazards created
by manufacturing and the resulting chemical reactions are the
responsibility of the manufacturer performing that manufacturing, as
they are the experts in the product and the chemistry they are
performing (Document ID 0359, pp. 1-2).
NACD commented that its members do business in different markets,
which makes it difficult for them to ascertain every type of downstream
use that could be considered normal conditions of use. NACD stated that
it is impractical for a manufacturer or distributor to know all
possible uses, hazards, or potential reactions associated with
downstream customers, and manufacturers should be only responsible for
communicating the hazards present in the form of the chemical as sold
(Document ID 0329, p. 8; 0423, Tr. 128-130; 0465, p. 4).
Innovative Chemical Technologies (ICT) stated that a chemical
producer cannot adequately guess all possibilities and then analyze
those scenarios for hazards to include on the SDS because a reaction
results in one or more new chemical substances, which may be more or
less hazardous than the reactants. ICT expressed concern that
compliance with the proposed revision would require chemical producers
to
essentially do a portion of a process hazard analysis (PHA) for
reaction products, focused on customer sites that it does not own or
control (Document ID 0324, p. 2). ACMA and PLASTICS submitted similar
comments (Document ID 0314, Att. 1, p. 12; 0318, p. 8). OSHA notes that
ACMA also asserted in their comment that the proposed language in
paragraph (d)(1) is economically infeasible but did not provide
financial data to corroborate the assertion. As explained in Section
VI.G., Economic Feasibility and Impacts, OSHA has determined based on
the record evidence that the requirements of this final rule are
economically feasible.
After reviewing the concerns expressed in the numerous comment
submissions on this provision, OSHA concludes that the agency's
intention was not clear as written and was therefore misinterpreted.
OSHA did not intend for an upstream supplier or manufacturer to
identify every conceivable use or process in which a downstream user
might apply the chemical and to classify these potential hazards of
chemicals downstream. OSHA's intent was to ensure classification only
for those downstream uses where the manufacturer knows or could
reasonably anticipate how the chemical will be used and where that use
creates a hazard that needs to be communicated in the workplace. The
record demonstrates that manufacturers have basic information on how
their chemicals will be used by downstream users and markets to those
uses. For instance, many chemical manufacturers have product
stewardship programs to address these very issues (Document ID 0443,
p.1; 0330, p.1). However, the agency is also aware that product
research and new uses will continue to be developed and that some
chemicals have so many uses it would be difficult to anticipate them
all. Therefore, the agency finds it would be unreasonable to expect
manufacturers to predict and account for every possible use downstream.
For example chemicals, such as toluene, that are often used as starting
materials for manufacturing other chemicals, would likely have too many
possible uses for the upstream chemical manufacturer to know or
reasonably anticipate the ways that it could be combined with other
chemicals. OSHA would not expect manufacturers of toluene, for
instance, to classify hazards of the products that use toluene as a
starting material in the manufacture of a downstream user's products.
However, manufacturers of toluene would still need to ensure that the
SDS had the appropriate information in Section 10 on stability and
reactivity that would help those downstream manufacturers consider the
risks of their specific processes.
Therefore, as explained above, OSHA has modified the language to
better reflect the agency's intent that hazard classification should
encompass hazards present during downstream uses or applications that
are known or reasonably anticipated by the manufacturer, importer, or
distributor, such as the intended use for which the substance is
manufactured.
Moreover, OSHA received comments describing situations where not
only would it be feasible for manufacturers to include hazard
information regarding known or reasonably anticipated uses or
applications, it would also greatly improve worker safety. Cal/OSHA
provided several examples of uses of materials that manufacturers
should have been aware of but did not include on the SDS (Document ID
0322, pp. 13-14; 0375, pp. 13-14). One such use was an aerosol
degreaser used in automotive repair facilities that was linked to cases
of neuropathy in automotive repair technicians. Cal/OSHA stated that it
was standard practice in the industry for the technicians who were
assigned the dirtiest jobs in an automotive repair facility to use
between six and 10 cans of degreasing solvent products in just one day
(Document ID 0322, pp. 13-14; 0375, pp. 13-14). The agency finds that
this example shows the utility of the new language in paragraph (d)(1)
because not only does it illustrate the intrinsic hazard presented by
the product, but demonstrates that this type of use would be
``reasonably anticipated'' to a manufacturer familiar with the
automotive repair industry, given Cal/OSHA's findings that this was a
pervasive practice in that industry.
Cal/OSHA also provided an example of workers in hair salons being
exposed to excessive amounts of formaldehyde formed as a reaction
product to hair straightening products used in the salons (Document ID
0451, Att. 1, pp. 3-4). Cal/OSHA had submitted this as an example of
their concerns that the proposed language ``normal conditions of use''
would ``open the door for producers--without sufficient downstream
information--to not disclose a chemical based on the assumption that
under `normal conditions of use,' no health-hazardous exposures would
occur,'' concerns which Worksafe echoed in their comments (Document ID
0451, p. 2; 0354, p. 1). However, OSHA finds just the opposite,
particularly with respect to the revised language that the agency is
adopting in this final rule. Since the conditions described by Cal/OSHA
are apparently commonplace in the salon industry, the formaldehyde
hazard would result from a ``known or reasonably anticipated use'' for
a manufacturer or distributor familiar with that industry and would
therefore be encompassed by paragraph (d)(1). OSHA believes that
clarifying hazard classification requirements under paragraph (d)(1)
will ensure that manufacturers, distributors, and employers understand
how to meet their obligation to disclose this information to workers
and that workers will be better protected.
Additionally, OSHA received examples of product stewardship
programs and SDSs that demonstrate companies are aware of and able to
determine the uses of their products, which further underscores the
feasibility and utility of requiring them to identify known or
reasonably anticipated uses. NIOSH also indicated that both individual
manufacturers and coalitions have product stewardship programs, which
allow sharing of information related to product uses, and cited ACC's
``Responsible Care'' program as an example. NIOSH described these
programs as a ``great tool'' for hazard communication (Document ID
0423, Tr. 39; 0456, Att. 2, p. 2). ACC, in its post hearing comments,
also discussed at length the various ways that some of their members
engaged with downstream users to ensure safety information was
thoroughly provided, including on-site training, customer notification
letters, surveys and questionnaires, and indicating additional
information on the SDS regarding typical reactions (Document ID 0468,
p. 5). NABTU also provided examples of SDSs and product stewardship
programs that account for downstream uses of chemicals (Document ID
0450, Att. 7).
In conclusion, OSHA agrees with commenters that it would not be
possible for every manufacturer, importer, and distributor to be aware
of every single use or application of its products, and the agency is
not requiring these entities to do the kind of intensive investigations
that many of the commenters described as infeasible. Additionally,
regulated parties will not immediately be aware of all uses when new
products are developed or when there are trade secret issues with
downstream users. Similarly, OSHA would not expect a manufacturer to
know every use of feedstocks (raw materials used to make other chemical
products), starting materials or commodity chemicals, solvents,
reactants, or chemical intermediates
where there could be thousands of uses or the substances are used in
downstream manufacturing to produce new chemical products. However, the
agency concludes that manufacturers must make a good faith effort to
provide downstream users with sufficient information about hazards
associated with known or reasonably anticipated uses of the chemical in
question. As discussed above, OSHA is finalizing language to make this
clear, and to tie the classification obligation to either the
manufacturer, importer, or distributor's own knowledge or facts that
the manufacturer or importer can reasonably be expected to know.
V. Arguments That It Would Be Impossible To Correctly Classify Uses Due
to Downstream Manufacturers' Trade Secret/CBI Issues
Several commenters suggested that full classification might not be
possible in situations where downstream users may not share usage
information due to confidential business information (CBI) or trade
secret concerns (see, e.g., Document ID 0291, pp. 5-6; 0324, p. 2;
0326, p. 4; 0337, pp. 2-3; 0348, p. 4; 0363, p. 4; 0367, p. 4; 0369, p.
5; 0347, p. 2; 0468, p. 3). OSHA would not consider a manufacturer or
supplier to know or be able to reasonably anticipate a downstream use
if the downstream user uses the chemical in a proprietary process,
producing derivatives that are trade secrets. Therefore, this situation
would not trigger the classification requirements under paragraph
(d)(1).
VI. Arguments That This Would Lead to Duplicative Classification
ICBA and others expressed concern about how OSHA's proposed new
language in paragraph (d)(1) would apply to chemicals like carbon
black, which are typically sold in bulk quantities for use in a
multitude of different downstream products. ICBA noted that because
those downstream products also contain various other substances, all of
the upstream manufacturers of the ingredient substances would have to
``independently and duplicatively classify[ ] downstream products,''
which would be inefficient and could lead to ``divergent hazard
classifications of the same product'' (Document ID 0291, p. 6; 0318, p.
2-9; 0348, pp. 1-4; 0461, pp. 1-2). ICBA stated that ``the downstream
user is in the best position to classify its own product.'' Similarly,
NAIMA stated that ``It is unclear how manufacturer-suppliers and
manufacturer-users would resolve a situation in which multiple
suppliers of reactants used in a particular downstream chemical
reaction are required to perform a hazard classification for that
reaction and reach different conclusions, which seems likely for any
chemical with broad uses'' (Document ID 0338, p. 3).
OSHA agrees that manufacturers of chemicals are responsible for the
classification of their own chemical products. As discussed above,
OSHA's intent in adding clarifying language to paragraph (d)(1) was not
to require upstream manufacturers to engage in hazard analyses with
respect to products created downstream, but rather to ensure that
upstream manufacturers provide sufficient hazard information about
their own products so that downstream users have the information they
need to conduct their own hazard analyses and/or take other appropriate
action. This will not result in duplicative or divergent classification
because the manufacturers, importers, and distributors will not be
required to do hazard classification unless they know or could
reasonably anticipate the uses with sufficient information to classify
the hazard. ICBA and NAIMA's concerns about duplicative classification
rest on the assumption that the responsible party will be required to
learn the processes of every downstream user and perform hazard
classification for each process, but as OSHA has clarified above, that
is not the case. Additionally, this change would not decrease the
quality of information provided to workers. On the contrary, as
indicated in the 1983 HCS, when manufacturers provide thorough hazard
information, applicable to a full range of reasonably foreseeable uses,
downstream manufacturers and employers will have the information
necessary to make informed choices for control measures without
limiting the downstream manufacturer from providing additional
information as warranted (48 FR 53307).
VII. Arguments That the Information Is Already Covered Under Other
Specific Sections of the SDS
The clarifying changes OSHA is making to paragraph (d)(1) also
clarify the requirements of Section 2 of the SDS because that section
requires the presentation of hazard information for chemicals.
Accordingly, several commenters provided comments relevant to paragraph
(d)(1) as it relates to the SDS. Several stakeholders commented that
the information OSHA proposed to clarify is required in section 2 of
the SDS is already covered in other sections of the SDS (Document ID
0303, p. 2; 0347, p. 2; 0468, Att. 2, p. 12; 0361, p. 1; 0329, pp. 7-8;
0356, p. 6; 0467, p. 4). Tom Murphy commented that there are limits to
the concept of ``foreseeable'' in the context of an emergency and that
the information is better covered under paragraph (h) Employee
information and training and placed under section 10(c) of the SDS
(Document ID 0277, p. 3). The American Welding Society (AWS) commented
that ``current requirements are adequate to ensure that manufacturers
continue to warn about the general nature of the anticipated physical
and health hazards arising out of product use, as appropriate, in
Sections 2, 8, 10 and 11 of the product Safety Data Sheet'' (Document
ID 0303, p. 2), while ACC commented that ``the requirement is
unnecessary as these hazards are already identified in sections 5, 9,
and 10 of the SDS. Anything beyond that is unrealistic and entirely
speculative'' (Document ID 0467, Att. 2, p. 14). ILMA commented that
this information should be in section 11 and section 15 (Document ID
0356, p. 6). The Archer-Daniels-Midland Company (ADM) and PLASTICS
stated that this information should be in other sections without
further explanation (Document ID 0361, p. 1; 0467, p. 11).
As OSHA discussed in the 2012 update to the HCS, the
standardization of the SDS format improves the effectiveness of the SDS
by providing a format that makes it easier for users to find
information (77 FR 17596). Additionally, the information commonly
wanted and used by employees, and of the greatest interest for
emergency responders is presented early in the SDS while more complex
or technical information is presented later (58 FR 17596). While it is
true that similar, but not identical, information may be contained in
multiple sections of the SDS and used for different purposes and
potentially by different readers of the SDS, the changes to paragraph
(d)(1) specifically require Section 2 to contain information on hazards
resulting from a change in the chemical's physical form and from
chemical reaction products when they are known or can be reasonably
anticipated. Although there does exist some overlap between Section 2
and Section 10, Section 2 provides workers with necessary, easily
understandable health and safety information, whereas Section 10
provides health and safety professionals information on when and how to
design safety systems to protect workers. Similarly, Section 5 of the
SDS provides information on fire-fighting measures which are specific
to types of hazards related to fire; Section 8 provides information on
exposure controls and personal protection but
does not indicate the actual hazards associated with the chemicals;
Section 11 provides information on stability and reactivity of a
chemical which is used primarily by medical professionals, occupational
health and safety professionals, and toxicologists (Document ID 0060,
p. 394); and Section 15, which is a non-mandatory section, permits
additional information on regulatory requirements. Therefore, Section 2
is the appropriate location for information about actual hazards and
the specific hazard classifications that workers can easily access. For
more detailed discussion on the various sections of the SDS, please see
the Summary and Explanation for Appendix D.
VIII. Arguments That the Proposed Paragraph (d)(1) Does Not Align With
the GHS or International Trading Partners
Several stakeholders commented that the language proposed in the
NPRM does not align with international trading partners, or the GHS
(Document ID 0314, pp. 12-13; 0326, p. 3; 0338, p. 2; 0348, p. 3; 0362,
p. 1; 0369, pp. 5-7; 0366, p. 1; 0347, pp. 4-5; 0468, Att. 2, p. 12).
AWS stated that the GHS uses the term ``hazard classification'' to
indicate only intrinsic properties of substances (or mixtures). AWS
said these hazardous properties are based on the hazards exhibited in
the form substances (or mixtures) are purchased, shipped, and received
in commerce, not from subsequent use in the workplace. AWS urged OSHA
to ``not deviate from the principles of classification based upon
intrinsic hazards and be consistent with the reasoned approach taken by
the authors of the GHS'' (Document ID 0303, p. 2). Hach made the same
point (Document ID 0323, pp. 4-5). Similarly, NACD commented that since
the proposed requirements in the SDS are not included in the GHS, the
proposal would make OSHA's requirements more divergent from the global
system rather than aligning with it (Document 0465, p. 5). ACC stated
that ``the requirement is not part of the GHS, so rather than
facilitating alignment, the change would have the opposite effect of
making the U.S. rules even more divergent from the global system''
(Document ID 0468, Att. 2, p. 12). The Vinyl Institute commented that
the language proposed in the 2021 NPRM was in contrast to language in
the EU CLP citing Article 5: ``The information shall relate to the
forms or physical states in which the substance is placed on the market
and in which it can reasonably be expected to be used'' (Document ID
0369, pp. 6-7).
Contrary to commenters' arguments, the GHS does not specify that it
only applies to chemicals in their shipped form or in commerce; it
states that it applies to all hazardous chemicals across stages in
their life cycles (Document ID 0060, p. 5). As explained above, OSHA
believes commenters have conflated the idea of intrinsic or inherent
hazards with hazards of a chemical as shipped. Additionally, OSHA
opined on the development and implementation of the GHS in the 2012
rulemaking to update the HCS. As discussed there, in developing the
GHS, it was recognized that countries' regulatory authorities would
need to have the discretion to address national circumstances in ways
that are suited to the regulatory perspective of the country. Thus,
authorities such as OSHA are free to make determinations about scope
and application issues while still being harmonized with the primary
provisions of the GHS (58 FR 17695). Therefore, OSHA disagrees with the
commenters' premise that any difference between the HCS and the GHS
means that OSHA is improperly deviating from the GHS or from its
trading partners.
In any event, OSHA interprets the EU CLP differently than the Vinyl
Institute and finds the changes to paragraph (d)(1) actually align with
similar provisions in other jurisdictions since the CLP guidance quoted
by the Vinyl Institute explicitly requires consideration of
``reasonably expected use'' during the classification process (Document
ID 0256, p. 55).
Additionally, since a number of other countries separately regulate
hazards of chemicals as shipped and chemicals in the workplace, OSHA is
improving alignment of labels with other countries that may only
regulate hazards of chemicals as shipped by clearly stating that
hazards related to downstream use only need to be on the SDS.
Therefore, the agency believes that the inclusion of this language
actually strengthens trading relations because it better aligns the HCS
with international jurisdictional requirements for labeling and
workplace hazard communication.
IX. Arguments That Proposed Paragraph (d)(1) Will Result in Expansion
of Tort Liability for Manufacturers
Several commenters stated that the proposed changes to paragraph
(d) would expand tort liability for manufacturers (Document ID 0314, p.
12; 0326, p. 4; 0366, p. 3; 0369, p. 4). Hach commented that ``expanded
legal obligation to perform hazard classifications at the downstream
levels creates more opportunities for inadequate hazard
communication,'' which could cause plaintiffs' attorneys to pursue
claims against upstream manufacturers (Document ID 0323, p. 5). NACD
and CCAE stated that because of liability concerns with attempting to
determine all downstream uses and chemical reactivity hazards, the
proposed change will result in several pages of ``legalese'' to
indemnify the entity on the SDS, which will not enhance worker safety.
Consequently, they stated, manufacturers and distributors should be
responsible for communicating the hazards of the material in the form
sold only (Document ID 0329, p. 8; 0423, Tr. 128-130; 0465, pp. 4-5;
0469, p. 3).
However, no commenter provided specific examples of case law or
other evidence to support their contentions that the proposed language
to update paragraph (d) would result in an expansion of tort liability.
Moreover, the OSH Act expressly provides that nothing in the statute
shall supersede, or in any manner affect, workers' compensation laws or
other common law or statutory rights, duties, or liabilities related to
employment-related injuries, illnesses, or fatalities (29 U.S.C.
653(b)(4)). Therefore, OSHA finds no merit to arguments that adoption
of the proposed changes to paragraph (d) would expand tort liability.
X. Arguments That the Proposed Paragraph (d)(1) Will Result in Software
Issues
Both ACC and NACD commented that computer systems used by most
larger companies to generate SDSs are automated using existing
formulations based on current rules and companies would incur a
significant burden to update the systems (Document ID 0347, Att. 1, p.
8; 0329, p. 5). NACD reasoned that, because many chemical manufacturers
and distributors rely on the services of outside software companies to
prepare SDSs, adopting the proposed changes in the SDS would create
complications for manufacturers and distributors. NACD indicated that
this change would require product-by-product evaluation of hazards,
``which is contrary to the basic principles of the GHS'' and which
would cause problems because much of the software used by manufacturers
relies on GHS classifications and data from the EU (Document ID 0465,
p. 5).
OSHA is not convinced that the changes to paragraph (d)(1) will
lead to significant burdens for industry. First, as to NACD's assertion
that there are no data sources for downstream reactions, SDS preparers
can use the same sources as they do for classification of other
chemicals as well as information from the manufacturer. Additionally,
if it were true that software companies could not respond to updates to
the GHS and changes in classification procedures, then neither OSHA nor
other countries would ever be able to make regulatory changes to
maintain alignment with the GHS (see Section VI., Final Economic
Analysis and Regulatory Flexibility Analysis). In fact, NACD did not
contend that there are technological barriers to creating compliant
software, only that existing software is not currently configured to
meet these requirements. Finally, because the new language simply
clarifies that classifiers must include hazards associated with known
or reasonably anticipated uses, these hazards are most likely already
classified elsewhere, such as the example discussed above where
formaldehyde was generated as a by-product during use of hair
straightening products (Document ID 0451, pp. 2-8). Accordingly, OSHA
finds that software-related concerns do not pose an obstacle to
adopting the new language in paragraph (d)(1).
XI. Arguments That the Inclusion of the Proposed Language Could Be
Misinterpreted as Including ``Articles''
Some commenters believed that inclusion of the originally proposed
language, ``normal conditions of use'' and/or ``foreseeable
emergencies,'' could be misinterpreted as including ``articles,'' which
are generally exempted from the HCS (Document ID 0339, p. 2; 0332, pp.
1-2, 4; 0358, p. 2; 0369, pp. 3-4). The Portable Rechargeable Battery
Association (PRBA) suggested that the proposed language demonstrated
``OSHA's intention to expand the purview of the HCS to include certain
products that have previously been exempted as articles'' (Document ID
0332, p. 4). The Vinyl Institute commented that ``it would be
inappropriate to consider changes in physical form through destruction
or recycling to be a normal condition of use that would change the
classification of a product as an article. Under such an unprecedented
approach, OSHA would disqualify almost every current article from
continuing to be treated as an article'' (Document ID 0369, pp. 3-4).
The Vinyl Institute indicated this concern was prompted by OSHA's
classification requirement with respect to downstream changes in
physical form under normal conditions of use such as: ``(a) Reduction
in particle size from combustible solids to combustible dust, (b)
Reduction in particle size from non-respirable to respirable, (c) solid
substances becoming corrosive or irritant when moistened or in contact
with moist skin or mucous membranes'' (Document ID 0369, pp. 3-4).
Similarly, AF&PA and AWC's joint comment stated that destruction and
demolition of wood products could be considered ``normal conditions of
use'' (Document ID 0287, pp. 5-6).
OSHA did not and does not intend the change in paragraph (d)(1) to
affect the definition of ``article'' or change the exemption status of
any product. The HCS defines ``article'' as ``a manufactured item . . .
which is formed to a specific shape or design during manufacture . . .
which under normal conditions of use does not release more than very
small quantities . . . of a hazardous chemical . . . and does not pose
a physical hazard or health risk to employees'' (29 CFR 1910.1200(c)).
Nothing in paragraph (d)(1) affects this definition. Moreover, to the
extent the commenters were concerned about the originally proposed
language ``normal conditions of use and foreseeable emergencies,'' that
language, as explained above, has been revised and does not appear in
the final rule.
XII. Arguments That Proposed Paragraph (d)(1) Will Result in Over-
Warning or Warning Fatigue for Downstream Chemical Users
Several commenters suggested that the proposed changes in paragraph
(d)(1) would lead to confusion and complexity of the SDS that could
lead to ``over-warning'' or ``warning fatigue'' as workers could be
receiving multiple warnings on the same chemical, or irrelevant hazard
information potentially turning the SDS into a ``novel.'' They argued
this could lead to workers being overloaded or overwhelmed with hazard
information that may be too confusing to discern the real hazards they
would be potentially exposed to (Document ID 0314, p. 10; 0318, p. 6;
0319, p. 2; 0337, p. 2; 0343, pp. 2-3; 0356, p. 8; 0369, p. 6; 0468,
Att. 2, p. 12; 0348, p. 4; 0444, p. 3; 0361, p. 1; 0362, p. 7; 0329, p.
8). Many of these comments are related to chemicals that are produced
in bulk quantities and intended to be ingredients in various downstream
chemical products. For example, NACD indicated that ``[a]ny chemical
that can be mixed with a wide range of other chemicals could have an
exponentially long and unknown list of hazards that `result from a
chemical reaction' '' (Document ID 0329, p. 8).
OSHA disagrees that the changes to paragraph (d)(1) create any
problem with warning fatigue. First, as explained above, manufacturers
need not classify hazards for every conceivable future use, just those
that are known or reasonably anticipated. Second, the SDS and the
product label serve two different purposes. As provided for in
paragraph (f)(1) of this final rule, hazards associated with known or
reasonably anticipated uses do not need to be included on a product's
label. Such hazards must be included in Section 2 of the SDS, but this
is appropriate because the SDS is meant to have more comprehensive
information available to workers who need or desire more details about
the product. OSHA is not dictating how this information is presented in
Section 2 of the SDS. SDS preparers have discretion to present the
information in an organized fashion to prevent confusion for the
downstream user.
XIII. Additional Comments
OSHA received additional comments that did not fit neatly within
any of the above categories. ACC stated its belief ``that OSHA has
conflated two separate obligations under the Hazard Communication
Standard--the scope of the HCS with respect to an employer's workplace,
and the scope of the hazard classification (known as the `hazard
determination' prior to HCS 2012'' (Document ID 0468, p. 2). ILMA and
PLASTICS made similar comments (Document ID 0314, pp. 2-3; 0356, p. 6).
OSHA believes that these concerns arose from the agency's proposed use
in paragraph (d)(1) of the terms ``normal conditions of use'' and
``foreseeable emergency,'' which both appear in paragraph (b)(2) of the
HCS, which describes the scope of the entire standard. Because the use
of those terms in paragraph (d)(1) created significant
misinterpretations, OSHA has changed the regulatory language for this
final rule, as explained above.
Several commenters also argued that the examples OSHA provided were
insufficient to support the broad nature of the proposed language in
paragraph (d)(1) (Document ID 0325, pp. 8-13; 0323, p. 4; 0316, pp. 3-
5, 0362, pp. 2-3). For example, Hach claimed that the examples OSHA
provided were unique situations and did not warrant the ``proposed over
broadening of the classification scope'' (Document ID 0323, p. 4).
OSHA disagrees with commenters who suggest that there is
insufficient evidence presented to support the requirement. While OSHA
provided several examples in the NPRM, other commenters, such as Cal/
OSHA and NABTU (as discussed above), have also provided additional
examples of situations where manufacturers should have reasonably
anticipated
downstream hazards but failed to warn of these hazards and workers were
harmed.
SAAMI was concerned that the proposed language in paragraph (d)(1)
would impose additional requirements on explosives since these types of
materials can be used for demolition or destruction as a normal
condition of use and that the classification as an explosive and the
resulting hazard communication is sufficient to alert users to the
potentialities (Document ID 0412, p. 3). OSHA believes that the
classification of explosives already accounts for many of the hazards
that would be associated with demolition or destruction because the
hazard is still explosiveness regardless of whether that risk is in
transport or during actual use of the explosives. However, the HCS
covers all health and physical hazards and there are some circumstances
of downstream use that need to be accounted for during the
classification process, such as if the explosive itself creates a toxic
atmosphere when used.
The National Association of Printing Ink Manufacturers (NAPIM)
suggested that OSHA should define the term ``reaction'' for paragraph
(d)(1) because some members of the regulated community may not
understand what OSHA intends it to mean in this context (Document ID
0317, p. 2). OSHA does not believe this is necessary. First, the term
``reaction'' is used in multiple ways throughout the HCS depending on
the context of the requirement. For example, in Appendix A it is used
to describe health effects (e.g., Table A.4.2) while in Appendix B the
term ``chemical reaction'' is part of the definition for explosives
(see B.1.1.1). Thus, OSHA believes that providing a single definition
of ``reaction'' for the whole standard could create confusion. OSHA
also does not believe the term ``chemical reaction'' needs a definition
because it is common knowledge for SDS preparers that ``chemical
reaction'' refers to a change of the chemical structure versus a mere
change in the physical form of a substance. Several commenters
indicated that the proposed language would only be reasonable if it
were limited to uses specified or directed by the upstream supplier and
that OSHA should ensure that paragraph (d)(1) only applies to a narrow
range of downstream reactions (see, e.g., Document ID 0316, p. 4; 0362,
p. 3; 0404, p. 3; 0367, p. 5; 0315, p. 3, 0359, p. 1-2). For example,
HCPA agreed that ``the chemical reactions should be included in the
hazard assessment in cases when multiple chemicals are sold together
with the intention that they'd be mixed together before use.'' However,
HCPA stated that the proposed changes in paragraph (d)(1) constitute
agency overreach, giving the example of concentrated cleaning products
that downstream customers dilute with water and the inability of the
manufacturer to know every type of a soil a cleaning product might be
used on (Document ID 0327, pp. 7-9; 0424, Tr. 15-17). They recommended
that the mixing of two or more chemicals be considered in
classification only when the label directs the user to use the chemical
in such a manner and excludes products where the label directs users to
only mix with water (Document ID 0327, p. 7). Similarly, Dow suggested
that the proposed paragraph be revised to state that the manufacturer
need only provide product chemical reaction hazard assessment based on
its intent and the knowledge of a chemical reaction that will occur
during the downstream use of its product as manufactured and sold
(Document ID 0359, pp. 1-2).
OSHA disagrees with these comments for several reasons. First, OSHA
would not expect any additional hazard classifications simply for
diluting a more concentrated chemical with water because, as HCPA
noted, such an action would only reduce the chemical's hazards, not
increase them. Second, under the finalized language in paragraph
(d)(1), manufacturers of cleaning products need only classify hazards
associated with known or reasonably anticipated uses of the products,
not every potential type of soil that a downstream customer might
clean. OSHA believes that ``known and reasonably anticipated uses'',
rather than only uses that are explicitly directed by the product's
label, is the appropriate requirement to provide sufficient information
to downstream employers and workers.
Two commenters suggested that OSHA should rescind the proposed text
and address unique situations of hazard identification and downstream
uses affecting the scope of HCS in a letter of interpretation rather
than updating the standard (Document ID 0323, p. 5; 0368, p. 3). OSHA
disagrees. The regulatory text is the first and primary place the
regulated community turns to understand its obligations under the HCS.
The agency is exercising its statutory authority to promulgate and
revise safety and health standards through notice-and-comment
rulemaking. OSHA has provided an opportunity for stakeholders to
comment on the proposed regulatory text changes, reviewed and
considered all of the comments, and made changes to the regulatory
text, where appropriate, based on the record as whole. By making this
change in the regulatory text, OSHA intends to ensure all regulated
parties are aware of this requirement and alleviate confusion on this
point. Addressing this issue in letters of interpretation would not
achieve the full extent of that goal.
XIV. Suggested Edits/Proposed New Language
OSHA also received several recommendations for changing the
proposed text for paragraph (d)(1), in addition to those discussed
above. PLASTICS and Vinyl Institute recommended that OSHA state
detailed and narrow conditions under which classification of downstream
reactions would be required. Their recommendations for such conditions
included where the manufacturer specifies the uses, provides all of the
chemicals, and specifies the complete process and process conditions.
Additionally, they recommended adding that the classification is only
contingent on the downstream users following the specified processes
(Document ID 0314, pp. 14-15; 0369, pp. 7-8). A joint comment from RISE
and CropLife also provided recommendations for new text that would
limit the classification requirement to only ``approved'' uses
(Document ID 0343, p. 3). RISE and CropLife explained that their
proposed revision ``narrows the scope of the hazard classification and
provides clarity so the provision can be more readily implemented
without over classification of the chemical hazards'' (Document ID
0343, p. 3).
ACC submitted proposed new text for paragraph (d)(1): ``In the case
of a hazardous product for which instructions for use, provided at the
time of the sale or importation, require its combination with one or
more products, mixtures, materials or substances resulting in the
creation of one or more new materials or substances that present one or
more new or more severe hazards not already identified on the safety
data sheet of the hazardous product, the safety data sheet must also
provide the following information elements, in respect of each new
material or substance and clearly indicate that they pertain to that
new material or substance: (a) the nature of the new or more severe
hazard; and (b) the content of the applicable specific information
elements set out in Appendix D to Sec. 1910.1200--SAFETY DATA SHEETS
(Sections 4-11)'' (Document ID 0347, Att. 1, p. 8). ACC stated that
while their preference was for OSHA to remove the proposed
language entirely, if the agency was unwilling to remove the language,
then OSHA should consider utilizing their draft text as it was modeled
after a similar Canadian provision (Document ID 0347, Att. 1, p. 9).
OSHA appreciates these stakeholders providing thoughtful proposals
for new language, but the agency finds that the suggested changes do
not represent the original intent which OSHA's proposal sought to
clarify. The commenters' suggested changes would narrow the current
obligations of the HCS (thereby reducing protections for workers) and,
in some cases, would introduce new ambiguity. PLASTICS' and Vinyl
Institute's suggested edits, while appearing to give clarity to what
they perceived OSHA's intent to be, contain qualifications that would
actually narrow the scope of the HCS and the classification
requirements. Similarly, in the language suggested by RISE and
CropLife, requiring classification only for uses specified on the label
would not only narrow the scope of the HCS but might incentivize
manufacturers to minimize the information provided to downstream users
to limit the need for classification. OSHA also does not believe that
ACC's language is less ambiguous. It would require the manufacturer to
decide if or when a hazard is more severe than a hazard already
identified or whether it is identified on the SDS. This also defeats
the purpose of having the hazards in one section upfront on the SDS to
ensure that the workers are aware of all of the potential hazards
without having to read the entire SDS. Accordingly, OSHA declines to
adopt the suggestions.
XV. Out of Scope Comments
OSHA received two comments on paragraph (d) that are out of scope
for this rulemaking. First, Cal/HESIS recommended that OSHA add a new
paragraph (d)(4) which would provide a source for authoritative lists
for chemical classifications (Document ID 0313, p. 4). This comment is
out of scope for this rulemaking, as OSHA did not propose a change
related to this issue. In addition, OSHA notes that this is already
addressed in the non-mandatory Appendix F of the HCS. Second, Cal/OSHA,
Worksafe, and the National Council for Occupational Safety and Health
(National COSH) commented that OSHA should include in paragraph (d)(2)
the ``single study rule'' (Document ID 0322, p. 2; 0354, p. 1; 0407, p.
12). This comment, too, is out of scope because OSHA did not propose a
change related to this issue. OSHA notes that the extent of its
incorporation of the single positive study is explained in the preamble
to the 2012 HCS (77 FR 17708) and is discussed further in the Summary
and Explanation for Appendix A.0.3.5 of this final rule.
To summarize, for the reasons discussed above, OSHA is finalizing
different language than what was proposed in the NPRM to better clarify
the extent of the obligations of manufacturers, importers, and
distributors and to better distinguish the requirements for hazard
classifications that must appear on the label and those that appear
only in the SDS. OSHA is not finalizing the proposed phrase ``under
normal conditions of use and foreseeable emergencies,'' but is adding
language providing that hazard classification shall include hazards
associated with the chemical's intrinsic properties, including ``(i) Ca
change in the chemical's physical form and; (ii) chemical reaction
products associated with known or reasonably anticipated uses or
applications.'' As discussed above, OSHA believes that stakeholders
should be familiar with the terms ``known'' and ``reasonably
anticipated'' as OSHA has used these terms in multiple standards,
guidance products, and LOIs. The agency finds that this language
captures the intent of the original language from 1983 and the intent
of the proposal while minimizing ambiguity. Finally, this clarification
will ensure that workers have the information necessary to protect
themselves from the hazards posed by chemicals to which they are
occupationally exposed.
(e) Written Hazard Communication Program
Paragraph (e) of the HCS provides specific requirements for
chemical manufacturers, importers, distributors, or employers to
develop, implement, and maintain a written hazard communication
program. Paragraph (e)(4) requires employers to make their written
hazard communication program available, upon request, to employees,
their designated representatives, the Assistant Secretary and the
Director of NIOSH.
The final rule contains one change to correct a reference in
paragraph (e)(4) that erroneously referred to 29 CFR 1910.20 instead of
29 CFR 1910.1020 when specifying when and how employers must make the
written hazard communication program available. OSHA's Access to
Employee Exposure and Medical Records standard was originally located
at Sec. 1910.20, but was renumbered to Sec. 1910.1020 in 1996 (61 FR
31429), resulting in the incorrect reference OSHA is now correcting. In
the NPRM, OSHA proposed this minor editorial correction after finding
that an inadvertent misprint occurred in the print version of the CFR.
Specifically, in the print version of the CFR, paragraph (e)(4)
references Sec. 1910.20 instead of Sec. 1910.1020 (OSHA's Access to
Employee Exposure and Medical Records standard). OSHA proposed to fix
this error. At the time the NPRM was published, the error was reflected
only in the print version of the CFR and the eCFR (www.ecfr.gov) was
correct, but at the time of this final rule, the eCFR is also
incorrect.
No stakeholders objected to the correction of the reference.
However, OSHA received one comment suggesting that a different standard
should be referenced to explain when and how employers must make
written hazard communication programs available. The U.S. Department of
Defense, Force Safety and Occupational Health (DOD) asserted that Sec.
1910.1020 ``is not a relevant reference for the hazard communication
program'' because it ``likely will not contain specific employee
exposure information'' (Document ID 0299, p. 2). They suggested that
OSHA cite to Sec. 1910.120(l)(1)(i) (the Hazardous Waste Operations
and Emergency Response (HAZWOPER) standard) instead and included
proposed language to implement their suggestion. They also suggested
adding a provision stating that the employer may limit employee
requests for copies of SDSs to chemicals that the requesting employee
was personally potentially exposed to (Document ID 0299, p. 2).
OSHA disagrees with DOD's suggestion that Sec. 1910.1020 is not
relevant and that Sec. 1910.120 should be referenced instead. Rather,
Sec. 1910.1020 is the appropriate reference here. Paragraph (e) of the
hazard communication standard has referenced OSHA's Access to Employee
Exposure and Medical Records standard since 1983. Section
1910.1020(c)(5) states that an ``employee exposure record'' means a
record containing any of several kinds of information including a
safety data sheet indicating a material may pose a hazard to human
health (Sec. 1910.1020(c)(5)(iii)) and a chemical inventory or any
other record that reveals the identity of a toxic substance or harmful
physical agent and where and when it is used (Sec.
1910.1020(c)(5)(iv)). Paragraph (e)(1)(i) of the HCS (Sec. 1910.1200)
requires that the written hazard communication program contain a list
of the hazardous chemicals known to be present using a product
identifier that is referenced on the appropriate safety
data sheet. Thus, the information a written hazard communication
program is required to contain classifies the program as an employee
exposure record within the meaning of Sec. 1910.1020. Section
1910.1020 also contains specific access requirements, including the
requirement to assure that employees are provided with records in a
reasonable time, location, and manner and the requirement that
employers assume the costs of records provision to employees and their
representatives. Therefore, citing to Sec. 1910.1020 for requirements
pertaining to an employer's written hazard communication program is
appropriate regardless of whether the program contains any specific
employees' exposure information.
On the other hand, Sec. 1910.120(l)(1), which addresses the
requirements for an emergency response plan under the HAZWOPER
standard, is intended to cover only procedures for emergency response
situations, does not reference exposure information, lacks the detailed
access procedures included in Sec. 1910.1020, and is not intended to
cover all workplaces with hazardous chemicals. As such, it is less
relevant to records access pertaining to routine and regular employee
exposures than Sec. 1910.1020.
OSHA also disagrees with DOD's suggestion that the agency amend
paragraph (e)(4) to include a statement that an employer need only
provide copies of a chemical's SDS to an employee if the employee was
potentially exposed to that chemical. This suggestion is beyond the
scope of this rulemaking because OSHA only proposed a typographical
revision to this section and did not propose any changes to the
substance of paragraph (e)(4). OSHA notes that the HCS does not require
employers to provide copies of SDSs to employees, only immediate
access. Where an SDS constitutes an exposure record under 29 CFR
1910.1020(c)(5), then 1910.1020's requirement to allow employee access
(which includes the opportunity to examine and copy) would apply.
For the reasons discussed above, OSHA has determined that Sec.
1910.1020(e) is appropriate to reference for access requirements
pertaining to written exposure control plans under HCS, rather than
Sec. 1910.120(l)(1). In the final rule, the agency has corrected the
technical error and retained the reference to Sec. 1910.1020.
(f) Labels and Other Forms of Warning
Paragraph (f) of the HCS provides requirements for labeling. In the
NPRM, OSHA proposed to modify paragraphs (f)(1), (f)(5), and (f)(11),
and also proposed a new paragraph (f)(12).
Paragraph (f)(1) of the HCS, Labels on shipped containers,
specifies what information is required on shipped containers of
hazardous chemicals and also provides that hazards not otherwise
classified (HNOCs) do not have to be addressed on these containers.
OSHA proposed to revise paragraph (f)(1) to provide that, in addition
to HNOCs, hazards resulting from a reaction with other chemicals under
normal conditions of use do not have to be addressed on shipped
containers. OSHA believed this information was not appropriate on
containers because it might confuse users about the immediate hazards
associated with the chemical in the container. However, because OSHA
believed information on hazards resulting from a reaction with other
chemicals under normal conditions of use is important for downstream
users, the agency did not propose to change the existing requirements
for these hazards to be indicated on SDSs (under Appendix D) and
addressed in worker training where applicable (under paragraph (h)).
OSHA also proposed to add the word ``distributor'' to the third
sentence of paragraph (f)(1) to make it consistent with the first
sentence.
OSHA did not receive comments on inclusion of ``distributor'' in
this paragraph, so the agency is finalizing that addition as proposed.
OSHA received several comments on the proposal that ``hazards resulting
from a reaction with other chemicals under normal conditions of use''
be exempt from inclusion on shipping labels. Michele Sullivan agreed
with OSHA that including this information on the label could be
confusing and potentially misleading, stating that including downstream
hazards on the container could cause confusion with DOT requirements
(Document ID 0366, p. 3). However, Cal/OSHA and Worksafe expressed
concern that exempting this type of information from the label would
withhold important information on chemical reactivity and hazards from
workers throughout the supply chain (Document ID 0322, pp. 2-3, 15-16;
0424, Tr. 166-168, 193-195; 0354, p. 5). Cal/OSHA also took issue with
using the term ``under normal conditions of use'' as the trigger for
the labeling exemption, contending that it is unrealistic to expect
chemical producers to be able to accurately identify such situations.
Cal/OSHA stated that chemical manufacturers would need to rely on
assumptions about downstream uses and if a manufacturer relied on
incorrect assumptions, this could result in essential chemical hazard
information being withheld (Document ID 0322, pp. 13-14).
OSHA disagrees with the assertion that not requiring this
information on the shipping label would allow manufacturers to withhold
important hazard information from workers. As explained in the NPRM,
information about downstream hazards is required to appear in Section 2
(Hazard(s) Identification) of the SDS, which must be readily available
to workers using the product. Additionally, omitting hazard information
created from later chemical reactions from the label properly places
the label's emphasis on the hazards associated with the chemical in the
container, while minimizing the potential for over-warning, which could
mask the hazards to which workers are exposed. However, as discussed in
the Summary and Explanation for paragraph (d), OSHA received many
comments expressing uncertainty about what the agency meant by the term
``under normal conditions of use.'' Accordingly, in this final rule,
OSHA has revised paragraph (d)(1) to remove the ``under normal
conditions of use'' language and replace it with language that more
clearly describes obligations for classification. Correspondingly, in
paragraph (f)(1), this final rule removes the reference to ``under
normal conditions of use'' and replaces it with a direct reference to
paragraph (d)(1)(ii). As finalized, this change to paragraph (f)(1)
maintains the proposed exemption but ensures consistency and minimizes
confusion about which hazards are required on both the label and the
SDS and which hazards are required solely on the SDS.
Hach commented that OSHA should update (f)(1)(vi) to be consistent
with the proposed changes in Appendix D to specify that the address and
phone number of the responsible party should be the U.S. address and
phone number (Document ID 0323, p. 11). OSHA is specifying that the
address and telephone number of the chemical manufacturer, importer, or
other responsible party required in Section 1 of the SDS,
Identification, must be United States domestic, in order to minimize
confusion on this point. As OSHA discussed in the NPRM, this change is
not a new requirement, but clarifies the previously existing
requirements of Appendix D, which requires that the name, address, and
telephone number of the responsible party, such as the chemical
manufacturer or importer, be listed on the SDS (86 FR 9722). OSHA
explained in a 2016 LOI that when chemicals are
imported into the United States, the importer (defined by the HCS as
being the first business with employees in the United States to receive
hazardous chemicals produced in other countries for distribution in the
United States) is the responsible party for purposes of compliance with
the HCS and is required to use a U.S. address and U.S. phone number on
the SDS (Document ID 0090). For the same reasons that OSHA is making
this change in Appendix D (see the Summary and Explanation for Appendix
D), OSHA agrees that the change should be made here as well. Therefore,
this final rule revises (f)(1)(vi) to include ``U.S.'' before
``address'' and ``telephone number.''
OSHA also proposed to add a new paragraph, (f)(1)(vii), that would
introduce a requirement that the label include the date a chemical is
released for shipment. The agency proposed this change in conjunction
with changes in paragraph (f)(11) related to relabeling of containers
that are released for shipment but have not yet been shipped. The
agency believed that providing the date a chemical is released for
shipment on the label would allow manufacturers and distributors to
more easily determine their obligations under paragraph (f)(11) when
new hazard information becomes available.
OSHA received numerous comments on this proposal. NAIMA supported
the inclusion of a date for release for shipment on the basis that
including such a date aligns with OSHA's other proposed changes related
to chemicals that have been released for shipment (Document ID 0338, p.
7). Tom Murphy commented that including a date on the label could
benefit workers but suggested that OSHA change the title ``Release for
Shipment'' to ``Packaged for Shipment'' to better reflect the intent of
(f)(1) (Document ID 0277, p. 2). Many commenters, however, objected to
or had concerns about the requirement of adding the release for
shipment date on the label. Some raised practical objections, such as
inadequate space on the label and lack of clarity about what the proper
date would be (Document ID 0361, pp. 1-2; 0362, pp. 3-4). Many others
questioned the need for such a requirement since manufacturers already
track the date of manufacturing through various means such as lot
numbers or manufacturing dates (Document ID 0327, p. 4; 0359, p. 3;
0323, pp. 8-9; 0315, pp. 1-2; 0321, p. 1; 0333, p. 1; 0339, p. 2; 0340,
pp. 4-5; 0348, p. 2; 0349 p. 1; 0423, Tr. 103, 195-196, 210-216; 0424,
Tr. 21). For example, Epson America, Inc. (Epson) commented that the
proposed requirement was ``not necessary and meaningless'' and that the
proposal did not make clear which date to use (Document ID 0288, p. 1).
NPGA, Dow, and Hach also commented that a required date on the label
would add unnecessary burdens and create confusion (Document ID 0364,
pp. 1-2; 0359, pp. 3-4; 0323, pp. 8-9). IMA-NA suggested that such a
date would not bear a connection to when the container was actually
ready to ship (Document ID 0363, p. 8). Michele Sullivan commented that
requiring the date on the label was contrary to international
harmonization because the GHS does not have such a requirement
(Document ID 0366, p. 4). Similarly, Hach observed that other
international partners (e.g., Canada) do not require the date of
release for shipment on the labels (Document ID 0323, pp. 8-9).
Some commenters indicated that OSHA underestimated the burden of
this requirement since either manufacturers would need to modify their
processes or the new requirement would preclude the use of pre-existing
labels, which save manufacturers time and cost (Document ID 0290, p. 1;
0315, pp. 1-2; 0358; p. 2; 0324, pp. 2-3, 7; 0359, pp. 3-4; 0323, pp.
8-9; 0424, Tr. 21; 0425, Tr. 73; 0368, p. 6). Others questioned whether
the proposal would create issues with labeling requirements imposed by
other agencies. For example, ILMA commented that some of their members
are also regulated by FDA and the use of a ship date as opposed to a
batch code may violate FDA regulations (Document ID 0444, p. 6).
Several commenters commented that the addition of this date on the
label could create confusion with very little benefit. AmeriGas stated
that a ``released for shipment'' date could lead to confusion with DOT
requalification dates (Document ID 0423, Tr. 210-216), and SAAMI
suggested that there could be confusion with expiration dates (Document
ID 0421, p. 2).
In addition, HCPA, ACC, and others recommended that OSHA allow
manufacturers and importers to use their own methods to track their
inventory throughout distribution rather than require an additional
date on the label (Document ID 0301, p. 1; 0315, pp. 1-2; 0327, p. 5;
0324, pp. 3, 7; 0423, Tr. 103). A comment jointly submitted by the
Compressed Gas Association (CGA) and the Gases & Welding Distributors
Association (GAWDA) recommended that the date be optional to provide
manufacturers flexibility, especially those that reuse containers and
inspect labels regularly (Document ID 0310, pp. 1-2).
OSHA appreciates the various views and comments submitted by
stakeholders. The agency finds compelling the arguments that the date a
chemical was released for shipment is not needed on labels because this
information is already available through other means and that the
addition of the date could cause confusion for downstream users due to
other (non-HCS) date requirements on the label. Since OSHA indicated in
the NPRM that the primary reason to include the ``release for
shipment'' date was to aid manufacturers and distributors in complying
with (f)(11), the agency finds it relevant that manufacturers and
distributors believe they already have adequate means to track their
inventory (86 FR 9698). OSHA therefore concludes it is unnecessary to
require dates be included on the label and is not including this
proposed requirement in the final rule.
Paragraph (f)(5) specifies label requirements that apply to the
transport of hazardous chemicals from workplace to workplace. In the
NPRM, OSHA proposed to add the heading ``Transportation'' to this
paragraph. The agency received no comments on the proposed new
paragraph heading, so is finalizing the heading ``Transportation'' as
proposed. In addition, OSHA is making one technical correction to
(f)(5)(i). The citation for the requirements of the Hazardous Materials
Transportation Act has been changed from 49 U.S.C. 1801 et seq. to 49
U.S.C. 5101 et seq. OSHA has updated the reference.
Finally, OSHA proposed to add two new subparagraphs to (f)(5) that
specify requirements related to the transportation of hazardous
chemicals. OSHA proposed to add a new paragraph (f)(5)(ii) to address
the transportation of bulk shipments of hazardous chemicals (i.e., in
tanker trucks, rail cars, or intermodal containers). The proposed
paragraph would specify that labels for bulk shipments of hazardous
chemicals may either be on the immediate container or may be
transmitted with shipping papers, bills of lading, or by other
technological or electronic means so that the information is
immediately available in print to workers on the receiving end of the
shipment.
OSHA received numerous comments on this proposed provision. Several
comments supported the proposed paragraph. ILMA indicated that the
option of using either physical or technological means to transmit the
information was beneficial (Document ID 0365, p. 12). ADM supported the
proposed language, finding it to be in full agreement with pre-existing
OSHA
guidance and industry practice (Document ID 0361, p. 2). Similarly, FCA
supported the addition of paragraph (f)(5)(ii) as long as the term bulk
shipment is not expanded to encompass intermediate containers (Document
ID 0345, pp. 5-6). OSHA notes that the regulatory text narrowly defines
bulk shipment to include only tanker trucks, rail cars, and intermodal
containers.
NAIMA, Hugo Hidalgo, and Ameren also supported the proposed new
paragraph, stating it provided needed clarity (Document ID 0297, pp. 2-
3; 0309, pp. 11, 16; 0338, p. 7). National Refrigerants, Inc. (NRI)
supported the addition of (f)(5)(ii) but requested that OSHA permit
sending the label electronically just once for multiple shipments with
the same materials (Document ID 0326, p. 7). Similarly, NACD and a
comment submitted jointly by the Association of American Railroads
(AAR) and the American Short Line and Regional Railroad Association
(ASLRRA) stated that there need only be one electronic transmission of
a label if multiple shipments are made of the same material (Document
ID 0329, pp. 3-4; 0351, pp. 2-4; 0465, pp. 3-4). OSHA disagrees with
these suggested changes since sending the label just once would not
provide the label to the receiver of each shipment at the time of
delivery. The intent of (f)(5)(ii) is to ensure the label is
immediately available to the person receiving the shipment while
recognizing advances in technology that allow manufacturers or
suppliers alternate methods of ensuring a hard copy is available.
While IPHMT and NPGA also supported the addition of (f)(5)(ii),
they requested that OSHA revise the paragraph to read as follows: ``It
is permissible for the label for bulk packaging of hazardous chemicals
to be on the container in a manner that does not conflict with the
requirements of the Hazardous Materials Transportation Act (49 U.S.C.
1801 et seq.) [now 49 U.S.C. 5105 et seq.] and regulations issued under
that Act by the Department of Transportation, or to be transmitted with
the shipping papers, bills of lading, or other technological or
electronic means so that it is immediately available to workers in
printed form on the receiving end of the shipment.'' These commenters
stated that their proposed language would clarify that OSHA does not
intend to prohibit markings required by DOT (Document ID 0336, p. 2;
0364, pp. 5-6). OSHA does not agree that this change is needed, since
(f)(5)(i) already provides that labeling used to comply with the HCS
must not conflict with the Hazardous Materials Transportation Act (49
U.S.C. 1801 et seq.) [now 49 U.S.C. 5101 et seq.] and regulations
issued under that Act by DOT.
Toby Threet also supported, in general, the provision for sending
electronic labels, with a minor edit to clarify that it is not the
worker who should be in printed form (Document ID 0279, p. 3). OSHA is
not convinced that the language as proposed is truly ambiguous and in
need of clarification.
Dow requested a slight change to the proposed text to allow for
greater latitude for where to affix the label on the bulk shipping
container, suggesting OSHA change ``may be on the immediate container''
to ``may be attached or affixed to the immediate container'' (Document
ID 0359, p. 2). DGAC expressed similar support for revisions that would
allow for flexibility of label placement (Document ID 0339, p. 2). OSHA
disagrees that this language is necessary or adds any additional
flexibility. OSHA already allows flexibility in its definition of label
in paragraph (c). The definition notes that labels may be affixed to,
printed on, or attached to the immediate container (or outside
packaging). Therefore, OSHA is maintaining the language as proposed.
NACD and others questioned the need for a label on a bulk shipping
container, suggesting that since the DOT placard and SDS are already
required, the end user will have the necessary safety and health
information without a label (Document ID 0329, pp. 3-4; 0315, p. 2).
OSHA disagrees with this assertion. OSHA does not require the SDS to
accompany the actual shipment of the chemical and therefore it may not
be immediately available upon delivery (although it must be readily
accessible to employees). Also, the DOT placard does not include the
full range of hazards covered by the HCS. Additionally, Idemitsu
Lubricants America Corporation (ILA) suggested that a hard copy of the
label was not necessary since the storage container on the receiving
side should already be appropriately labeled (Document ID 0315, p. 2).
OSHA disagrees, since the person who is unloading the material from the
bulk shipment may not have immediate access to the storage vessel and
its label.
NIOSH commented that proposed (f)(5)(ii) was practical and would
not result in additional risk to the worker. However, NIOSH recommended
that OSHA have a mechanism to verify that the label information is
transmitted (Document ID 0281, Att. 2, p. 4). OSHA agrees that some
sort of acknowledgement or acceptance of this information from the end
user is important to ensure that the information is appropriately
received. Therefore, in this final rule OSHA is revising the proposed
language to include that if the label is transmitted in a means other
than a label on the bulk shipment container or in printed form, the
recipient of the shipment must agree to receive the labels by an
alternate method. OSHA is also revising the word ``may'' to ``must'' in
the first sentence of (f)(5)(ii) to clarify that the label preparer
must choose one of the options provided in the paragraph.
Both Cal/OSHA and Worksafe objected to permitting shippers to send
labeling information electronically, expressing concern that this
method could leave workers who handle containers during shipment
unaware of their contents and leave emergency responders unaware of the
presence of hazardous materials and unable to respond safely to an
emergency that occurs during shipment (Document ID 0322, pp. 2, 14-15;
0375, pp. 2, 14-15; 0354, p. 5). DOT has jurisdiction over hazardous
chemicals while they are in transport and has provided alternate
methods to ensure the safety of people transporting hazardous materials
via packaging and labeling as well as to ensure that emergency
responders are aware of the hazards in case of an emergency. The HCS,
in contrast, is concerned with chemical hazards in the workplace after
transport has concluded. The purpose of providing the HCS label either
on the bulk shipping container or with the bill of lading is to ensure
that the downstream recipient has the information immediately upon
delivery. This long-standing requirement ensures that the recipient has
the information immediately while not posing any potential conflicts
with the placarding required by DOT.
Steven Wodka expressed concern that permitting electronic
transmission of labels will result in workers on the receiving end of
the shipment not having necessary hazard information quickly enough.
Wodka stated that warning labels should appear at the point of danger
where they would be most effectively seen, and that permitting
electronic transmission of labels will lead to a delay between the bulk
shipment's arrival at the customer's plant and the placement of the
appropriate label, even at the most OSHA-compliant workplaces (Document
ID 0312, pp. 2-5). As noted above, to further address the concern that
labels should be immediately available at the point of danger, OSHA is
revising the proposed language of
(f)(5)(ii) to include a requirement that the recipient of a shipment
must agree to receive labels electronically. OSHA believes that the
proposed regulatory language requiring that labels be ``immediately
available to workers in printed form on the receiving end of
shipment,'' coupled with the new language in the final version
requiring recipients to consent to electronic delivery of labels,
addresses the delay concerns.
If a manufacturer, importer, or distributor uses electronic
transmission of product labels for bulk shipments, they must ensure the
recipient chooses to ``opt-in'' to accept the electronic transmission.
A downstream user/recipient may choose to ``opt-out'' of an electronic
distribution system from a manufacturer, importer, or distributor at
any time. If a downstream user/recipient does opt out, the
manufacturer, importer, or distributor must then ensure a product label
is on each bulk shipment in accordance with paragraph (f)(1) or provide
a hard copy of the product label with shipping papers or bills of
lading. As a note, this provision does not change the existing
obligations of the downstream employer to ensure that any chemical
container in the workplace is labeled in accordance with paragraph
(f)(6) before any worker uses the chemical. A tanker truck or railroad
tank car may be labeled in accordance with paragraph (f)(7) when
considered a stationary process container.
In sum, OSHA is finalizing paragraph (f)(5)(ii) with revisions to
clarify that the label may be electronically transmitted only with
agreement from the receiving end. Electronic transmission of product
labels for bulk shipment may be accomplished in numerous ways through
various electronic platforms including computer systems, facsimile, or
bar or QR code, as long as the product label is immediately available
in printed form on the receiving end of the shipment.
As discussed in the NPRM, under the 2012 HCS, Appendix C paragraph
C.2.3.3 provides that where a pictogram required by DOT appears on a
shipped container, the HCS pictogram for the same hazard (specified in
C.4) shall not appear. This provision was intended to prevent confusion
associated with having two different representations of the same hazard
on the container (77 FR 17728). However, since 2012, DOT has updated
its regulations to indicate that it does not consider the HCS pictogram
to conflict with the DOT pictogram, and based on this, OSHA no longer
believes that having both pictograms will create confusion for workers
handling the chemical (49 CFR 172.401). Accordingly, in the NPRM OSHA
proposed to: (1) delete the language currently in paragraph C.2.3.3
from Appendix C and (2) add new paragraph (f)(5)(iii) to provide that
where a DOT pictogram appears on a shipped container, the Appendix C
pictogram for the same hazard is allowed, but is not required, on the
HCS label.
For example, in the case where a chemical is shipped in only its
immediate container, such as a 55-gallon drum containing a flammable
liquid, both a DOT label and an OSHA-compliant label would be required.
Under the 2012 standard, the flame pictogram on the OSHA-compliant
label would be prohibited because the DOT label would contain the
equivalent pictogram. The proposed change would allow, but not require,
the flame pictogram to appear on the OSHA-compliant label. This means
chemical manufacturers could use the same labels for shipping
containers and for containers that are solely used in the workplace;
this would avoid information loss and eliminate the need to develop or
print additional labels.
OSHA received several comments relevant to this proposed change.
ILMA supported harmonizing the HCS with DOT because it will ``reduc[e]
confusion regarding hazards, not only for workers but for the
businesses that must juggle two different labeling rules'' (Document ID
0356, p. 12). IPHMT commented that the proposed regulatory language did
not make it sufficiently clear that adding the HCS pictogram was
permissible but optional, rather than required. They requested the
agency amend the proposed language to clarify that the addition of the
HCS pictogram with the DOT pictogram is permissible but not required
(Document ID 0336, p. 3). OSHA disagrees that additional language is
needed; the proposed regulatory text states clearly that the HCS
pictogram ``is not required on the label.'' NPGA and IPHMT also
commented that the agency had not made a compelling case that no
confusion would ensue if both pictograms were required and this might
affect emergency responders' response (Document ID 0336, p. 3; 0364, p.
6). However, these commenters did not provide any evidence that there
would be or has been confusion due to two distinctly different
pictograms. OSHA notes that the DOT placard is larger than and separate
from the OSHA-compliant label, enabling emergency responders to
distinguish between the two types of labels. Moreover, these commenters
provided no reason for OSHA to disagree with DOT's conclusion, based on
that agency's experience and expertise, that confusion should not arise
from inclusion of both pictograms.
SOCMA supported the proposed change, stating that ``DOT has updated
its regulations to indicate that it does not consider the HCS pictogram
to conflict or cause confusion with the DOT pictogram for the same
identified hazard. This provision simply harmonizes labeling
regulations between OSHA and DOT while simplifying the dual labeling
requirements for regulated entities'' (Document ID 0367, p. 5).
DOD asked OSHA to clarify whether the HCS pictogram is permitted or
required once the container reaches its destination (Document ID 0299,
p. 2). OSHA intends that if the immediate container bears a DOT
pictogram, the same pictogram does not need to also be on the HCS
label, as long as the DOT pictogram is not removed or defaced. The end
user would not need to add the corresponding HCS pictogram.
NACD suggested alternate language to distinguish between DOT
terminology for ``marking'' a shipping container and OSHA terminology
for ``labeling'' hazardous chemicals. They suggested that OSHA remove
two references to ``the label'' from proposed (f)(5)(iii) (Document ID
0329, p. 4). OSHA partially agrees that the use of the term ``the
label'' for both DOT requirements and OSHA requirements may be
confusing because DOT sometimes uses the term marking rather than
labeling. However, the use of the term ``on the label'' to reference
OSHA labeling is appropriate. Therefore, OSHA is removing the first
reference to ``the label'' from the text of (f)(5)(iii); the text as
finalized reads, ``Where a pictogram required by the Department of
Transportation under Title 49 of the Code of Federal Regulations
appears on a shipped container, the pictogram specified in Appendix C.4
of this section for the same hazard is not required on the label.''
NACD also suggested that OSHA require that the pictogram(s), hazard
statement(s) and signal word(s) be in the same field of view as the
DOT's hazard class symbol, so workers could view all hazard information
at once, in order for the HCS pictogram to not be required (Document ID
0329, p. 4). OSHA disagrees with this suggestion. The DOT markings are
used for different purposes and the size and location may be dictated
in such a way that it would not be feasible to have them in the same
field of view. Therefore, the agency is finalizing (f)(5)(iii) as
proposed with the exception of removing the phrase ``the label for''
where it referred to DOT requirements.
In the 2012 HCS, paragraph (f)(11) requires that chemical
manufacturers, importers, distributors, or employers who become newly
aware of any significant information regarding the hazards of a
chemical revise the labels within six months of becoming aware of the
new information and ensure that labels on containers of hazardous
chemicals shipped after that time contain the new information. OSHA
recognizes that, on some occasions, a chemical manufacturer or importer
may become aware of significant hazard information after a chemical has
already been labeled but before it is shipped. Therefore, in the NPRM
OSHA proposed to add a sentence to paragraph (f)(11) providing that
chemicals that have been released for shipment and are awaiting future
distribution need not be relabeled; however, the chemical manufacturer
or importer must provide the updated label for each individual
container with each shipment. The purpose of these changes is to
account for the long distribution cycles of some products and the
potential hazards workers could face in relabeling the immediate
containers of hazardous chemicals that have already been prepared for
shipment.
Following publication of the 2012 updates to the HCS, OSHA received
feedback related to difficulties some chemical manufacturers were
having complying with paragraph (f)(11), particularly in the case of
chemicals that travel through long distribution cycles (see 86 FR
9699). Many products have straightforward supply chains and are
packaged, labeled, and promptly shipped downstream. Other products, for
example in the agrochemical sector, are packaged and labeled when they
leave the chemical manufacturer's facility, but they may reside at a
warehouse or distribution facility for extended periods of time (e.g.,
several years) before being shipped downstream. There are also
instances where products may be returned from the downstream users to
the distribution facility and then shipped to other customers (86 FR
9699).
In addition to the compliance difficulties noted by manufacturers,
OSHA is aware that the act of relabeling (or in some cases repackaging)
these products in warehouses or distribution facilities has the
potential to pose occupational safety and health risks to employees.
Relabeling each individual container may require that employees open
already secure packaging, a process that may result in workplace
hazards such as the potential for chemical exposures.
OSHA has previously recognized the complexities involved with
relabeling existing stock of hazardous chemicals. Following
promulgation of the 2012 HCS, the HCS compliance directive (Document ID
0007) provided enforcement guidance on the labeling of existing stock.
Before June 1, 2015 (for manufacturers and importers), and before
December 1, 2015 (for distributors), OSHA permitted chemical
manufacturers, importers, and distributors with existing stock that was
packaged (e.g., boxed, palletized, shrink wrapped, etc.) for shipment
and labeled in accordance with the pre-2012 version of the HCS to ship
those containers downstream without relabeling the containers with HCS
2012-compliant labels. However, the chemical manufacturer or importer
generally had to provide an HCS 2012-compliant label for each
individual container shipped and the appropriate HCS 2012-compliant
SDS(s) with each shipment. After those deadlines, employers were
required to ensure that each container was labeled with an HCS 2012-
compliant label prior to shipping. OSHA used this enforcement policy as
a basis for the proposed revisions to paragraph (f)(11). OSHA sought
commenters' input on whether the proposed changes would adequately
address issues associated with relabeling in cases of long distribution
cycles, whether the proposed changes would provide sufficient
flexibility, and whether the proposed revisions would alleviate safety
concerns that would otherwise be associated with the relabeling of
packaged stock.
OSHA received numerous comments on this proposed provision. A
comment jointly submitted by the Fertilizer Institute (TFI) and the
Agricultural Retailers Association (ARA) supported the proposal and
stated that it would reduce their burden without impacting the hazard
information (Document ID 0340, pp. 4-5). Tom Murphy supported the
provision but indicated it could be clearer if the agency changed the
term ``release for shipment'' to ``packaged for shipment'' (Document ID
0277, p. 2). NIOSH, NAIMA and Ameren also expressed support, noting
that the provision would allow manufacturers with long distribution
cycles the opportunity to send updated labels with the shipment while
avoiding unnecessary risk to workers (Document ID 0281, Att. 2, p. 4;
0338, p. 7; 0309, p. 11). NIOSH recommended that clear responsibility
be established to ensure labels accompany shipment. OSHA agrees; it is
the responsibility of the originator to ensure updated labels accompany
the shipment.
Some commenters expressed confusion about what the proposed
provision would require; in particular, they appeared to interpret the
proposed provision as mandatory rather than optional. API and Michele
Sullivan urged OSHA to make the proposed provision optional, as it
would not be relevant to many supply chain operations (Document ID
0316, pp. 4-5; 0366, p. 4). NAPIM appeared to read the proposed
provision as requiring manufacturers to place an updated label on each
container that had already been prepared for shipment (Document ID
0317, p. 2). NPGA and a comment jointly submitted by CGA and GAWDA
stated that the proposed provision would be inappropriate for
manufacturers of cylinder gas products and urged the agency not to
include it in the final rule (Document ID 0310, p. 2; 0385, p. 2; 0364,
p. 4). OSHA notes that the proposed provision was intended to be
optional and is revising the language in the final version to clarify
that manufacturers have the option to adopt the provision's alternate
labeling procedures but are not required to do so. Manufacturers,
distributors and importers can always follow the requirements for
updating labels as laid out in the first part of (f)(11). OSHA is also
revising the title of paragraph (f)(11) from ``Release for Shipment''
to ``Label Updates'' to better reflect the true purpose of this
provision: providing requirements for updating information on labels.
This change is similar to a suggestion submitted by Toby Threet, that
OSHA should revise the title ``to something more representative of the
entire paragraph, such as `Revision of Labels''' (Document ID 0279, p.
5).
Some commenters conditioned support for the changes on OSHA
eliminating or adjusting the correlating proposed requirement to add
the date of ``release for shipment'' on the label (Document ID 0327, p.
5; 0347, Att. 1, pp. 9-11; 0361, p. 1). As discussed above, OSHA has
decided not to adopt its proposed requirement to include the ``release
for shipment'' date on the label in this final rule.
Other commenters, while supporting this provision in principle, did
not support shipping the updated label with the shipment. Several
commented that doing so would inappropriately place the burden on the
downstream user to update the label on site. For example, the Medical
Device Transport Council (MDTC) strongly supported the relief from
relabeling that (f)(11) would afford but did not support placing the
burden
on subsequent distributors and customers to apply the updated labels to
the containers (Document ID 0358, pp. 2-3). Likewise, DGAC commented
that it does not support this provision as it places the burden on
subsequent distributors and their customers (Document ID 0339, p. 3).
Similarly, others including Dow commented that shipping unaffixed
labels could create issues with safety and raise liability issues, and
that there would be no way to ensure that relabeling would even take
place (Document ID 0349, p. 1; 0359, pp. 2-3; 0368, pp. 5-6). The
agency believes that the commenters are exaggerating the nature of any
additional burden on downstream users. The purpose of the accommodation
proposed in (f)(11) is to avoid the burdens and hazards that can come
with relabeling containers in a specific, narrow set of circumstances,
while still providing the up-to-date information to downstream users.
If upstream manufacturers are concerned about liability, they can opt
not to take advantage of this optional accommodation and instead update
the label at the point of shipment.
Other commenters requested flexibility on how and when to send the
labels downstream, such as sending them electronically and/or in
advance of the shipment, or suggested it is not necessary to send
updated labels at all since the downstream user already has the
information on the SDS (Document ID 0279, p. 5; 0297, pp. 5-7; 0319, p.
2; 0327, p. 5; 0345, pp. 4-5; 0349, p. 1; 0368, pp. 5-6). ACI indicated
that new processes would need to be put in place to provide the updated
label (Document ID 0319, p. 2). However, it is important to ensure that
downstream users have the most up-to-date information at the time the
hazardous chemical is received. Allowing the label to be sent
separately from the shipment or relying on the SDS would fail to ensure
that the downstream user has the updated label with each container.
OSHA again notes that this provision is optional, so if a manufacturer
does not have a mechanism to provide the updated label with the
shipment or is concerned about liability, they can relabel each
container prior to shipment.
Several commenters stated that they found the term released for
shipment to be confusing (Document ID 0329, p. 4; 0465, p. 4; 0324, p.
3). OSHA is adding a definition of released for shipment in the final
rule (see the Summary and Explanation discussion for paragraph (c)).
Cal/OSHA opposed the proposed update, characterizing it as an
``additional delay in relabeling'' that would ``expose[ ] workers
throughout the supply chain to undisclosed chemical hazards'' (Document
ID 0322, p. 15). OSHA disagrees that the proposed provision will cause
a delay in downstream workers receiving the correct label information
because it would require updated labels to be sent together with every
shipped container. In providing this accommodation OSHA is providing
flexibility to manufacturers in a way that minimizes potential hazards
to upstream workers who could be exposed to hazards due to relabeling
while still providing the updated label information with the shipped
product within the required timeframe.
Finally, several commenters requested clarification about aspects
of the proposed provision. NRI asked whether this accommodation applies
to any container filled, sealed, and labeled by the manufacturer before
the expiration of the six-month deadline (Document ID 0326, p. 6). The
answer is yes. NRI also asked whether the provision would apply to
labels on a chemical's immediate container as well as labels on
immediate outer packages holding small containers (Document ID 0326, p.
6). This answer is also yes: this accommodation would apply to
containers within an immediate outer package, as long as the immediate
outer package is already released for shipment.
The Vinyl Institute asked whether the exception applies when the
immediate container is filled and labeled, but the immediate container
has not yet been placed in its kit or outer container, palletized, and/
or shrink wrapped (Document ID 0369, pp. 8-9). PLASTICS supported the
proposed provision but suggested a supplemental statement to state
that: ``The `released for shipment' criterion would be satisfied if the
immediate container were filled, sealed, and labeled by the deadline
even if the immediate container (1) has not yet been placed in its kit
or outer container, palletized, and/or shrink wrapped, or (2) the
product is on a temporary QA hold and is subsequently cleared for
distribution'' (Document ID 0314, p. 19). In the Vinyl Institute's
question and in PLASTICS' suggestion, it appears that the immediate
containers still would need to be packaged for shipment, so they would
not meet the definition of released for shipment discussed previously
in the Summary and Explanation for paragraph (c), and the exception
would not apply.
IMA-NA asked OSHA to implement staggered timelines for label
updates based on the severity of the hazard, indicating that a Class 1
hazard should have a short timeline and a Class 2B hazard could wait as
much as twelve months for new labeling (Document ID 0363, p. 8). This
comment is out of scope for this rulemaking since OSHA did not propose
to change the basic schedule for updating labels after learning of new
hazard information. In addition, the agency believes downstream users
must have the updated information available on the immediate container
as quickly as possible regardless of the severity of the hazard.
For the reasons discussed above, OSHA is modifying the proposed
text for (f)(11) to make clear that for chemicals that have been
released for shipment and are awaiting further distribution, the
chemical manufacturer, importer, or distributor has the option not to
relabel after learning significant new hazard information. However, if
they choose to take that option, they must produce updated labels for
each container and send those labels with the shipment for the
downstream users.
Finally, OSHA proposed a new paragraph, (f)(12), to address small
container labeling. The 2012 HCS required that all shipped containers
be labeled with the information specified in paragraph (f)(1). Many
stakeholders have told OSHA that they have difficulty including all of
the required information from paragraph (f)(1) on the labels they use
for small containers. In some cases, the information becomes too small
for a person to read it, and while it is sometimes possible to use
alternate types of labels (such as pull-out labels or tags), it is not
always feasible to do so (86 FR 9699). In response to these concerns,
through LOIs and the HCS compliance directive, OSHA provided a
practical accommodation to address situations where it is infeasible to
provide all HCS-required label information directly on small containers
through the use of pull-out labels, fold-back labels, or tags (see 86
FR 9699). This practical accommodation allows limited information to be
included on the small container label, but requires complete label
information to be provided on the outside packaging. In the NPRM, OSHA
proposed to incorporate this practical accommodation into the standard
in new paragraph (f)(12).
OSHA proposed that all of the new small container labeling
provisions apply only where the chemical manufacturer, importer, or
distributor can demonstrate that it is not feasible to use pull-out
labels, fold-back labels, or tags containing the full label information
required by paragraph (f)(1). Proposed paragraphs (f)(12)(ii)(A)-(E)
would provide that labels on small
containers that are less than or equal to 100 milliliter (ml) capacity
must include, at minimum: product identifier; pictogram(s); signal
word; chemical manufacturer's name and phone number; and a statement
that the full label information for the hazardous chemical is provided
on the immediate outer package. Proposed paragraph (f)(12)(iii) would
provide that no labels are required for small containers of 3 ml
capacity or less where the chemical manufacturer, importer, or
distributor can demonstrate that any label would interfere with the
normal use of the container; however, that same proposed provision
states that if a container meets the conditions of (f)(12)(iii) and no
label is required, the container must bear, at minimum, the product
identifier. For example, the product identifier (e.g., chemical name,
code number or batch number) could be etched on a 3 ml glass vial
(container) to ensure that the identifier remains fixed to the vial.
This type of identification would ensure that the chemical in the small
container can be identified and matched with the chemical's full label
information.
Proposed paragraph (f)(12)(iv) would provide that for any small
container covered by paragraph (f)(12)(ii) or (iii), the immediate
outer package must include the full label information required by
paragraph (f)(1) for each hazardous chemical in the immediate outer
package, along with a statement that the small container(s) inside must
be stored in the immediate outer package bearing the complete label
when not in use. This proposed provision would also state that labels
affixed to the immediate outer package must not be removed or defaced,
as required by existing paragraph (f)(9).
OSHA intended these proposed changes to provide chemical
manufacturers, importers and distributors with flexibility in labeling
small containers. The proposal was consistent with the small packaging
examples provided in the GHS Annex 7: Examples of Arrangements of the
GHS Label Elements (Document ID 0197, pp. 431-436), and would result in
better alignment with Health Canada's HPR small capacity container
requirements (Document ID 0051). Specifically, the HPR, under 5.4(1),
provides exemptions from certain labeling requirements (such as
precautionary statements) for small capacity containers of 100 ml or
less. In addition, under 5.4(2), the HPR provides labeling exemptions
for containers of 3 ml or less if the label interferes with the normal
use of the hazardous product. OSHA requested comments on the
feasibility of the proposed small container labeling provisions as well
as whether the proposed changes would improve safe handling and storage
for chemicals in small containers.
OSHA received numerous comments on proposed paragraph (f)(12). Most
commenters supported adoption of (f)(12) (Document ID 0281, Att. 1, p.
4; 0309, p. 16; 0316, p. 6; 0323, pp. 6-8; 0329, pp. 5-6; 0338, pp. 7;
0339, pp. 3-4; 0345, p. 3; 0346, pp. 1-2; 0347, Att. 1, pp. 12-13;
0349, p. 1; 0359, p. 4; 0361, pp. 2-3; 0366, p. 4; 0367, p. 3). FCA
described proposed (f)(12) as a ``substantial improvement'' and
``strongly urge[d]'' adoption of the provision (Document ID 0345, p.
3). The Flavor and Extract Manufacturers Association agreed that trying
to include all the information required on a full-sized label on small
packages is infeasible and voiced support for the flexibility that
(f)(12) would provide (Document ID 0346, pp. 1-2). NAIMA called
proposed (f)(12) a ``common sense'' solution (Document ID 0338, p. 7).
While API noted that the addition of proposed paragraph (f)(12) to the
HCS would likely impact laboratory samples, they indicated no concerns
about adding it (Document ID 0316, p. 6).
Other commenters, while supporting this accommodation, had
additional recommendations. ACC voiced general support for adding
paragraph (f)(12) but recommended that the agency expand full relief to
any container below 100 ml, eliminating the need for separate
provisions for 3 ml and 100 ml (Document ID 0347, Att. 1, pp. 12-13;
0406, Att. 1, pp. 12-13). OSHA disagrees with this recommendation. The
information on the immediate container is essential for worker safety
and most containers, except for the very smallest, have enough room on
the immediate container (either attached directly or with the use of
tags or pull-out labels) to provide at least minimal information.
NACD and Loren Lowy recommended that the small package label also
reference the SDS (Document ID 0329, pp. 5-6; 0333, p. 1; 0465, pp. 4-
5). OSHA does not believe this is necessary. Workers should already be
trained on the hazards they are exposed to and have ready access to the
SDSs. Space on small containers is at a premium and including
unnecessary references to the SDS might detract from the hazard
information. However, NACD or others can add this statement if they
deem it appropriate.
NIOSH recommended that outer packages be ``water resistant''
(Document ID 0281, Att. 1, p. 4). While OSHA believes ``water
resistant'' packaging might be beneficial, this suggestion is beyond
the scope of this rulemaking because OSHA did not propose any new
requirements related to the durability of labels.
Hach supported the small package labeling provision but suggested
that OSHA eliminate the requirement to include a U.S. phone number,
stating that this takes up valuable label space and reduces
harmonization with trading partners such as Canada and Mexico (Document
ID 0323, pp. 6-8). OSHA disagrees with this suggestion. The phone
number should be maintained on the label since this provides the worker
with immediate access to where they can seek additional information if
the SDS is not in the immediate vicinity.
Givaudan, PLASTICS, the Vinyl Institute, and ACA suggested that
OSHA eliminate the need to show infeasibility while ICT requested that
OSHA explain what the agency means by ``demonstrating that it is not
feasible'' (Document ID 0293, p. 1; 0314, pp. 17-18; 0369, p. 9; 0324,
p. 4; 0368, pp. 7-9). Michele Sullivan also noted that neither Canada
nor the GHS requires proof of infeasibility (Document ID 0366, p. 4).
OSHA maintains that requiring a showing of infeasibility is
appropriate. It is imperative that, wherever possible, workers have the
full label information on the immediate container to ensure safe use at
all times. If this is demonstrated to be not feasible (for example, due
to space considerations or extraordinary economic considerations), then
OSHA has provided a way to minimize these impacts while still providing
valuable information to workers. The label provides a concise,
immediate, and conspicuous visual reminder of chemical hazards at the
site where the chemical is used; reducing this information where it is
feasible to provide the entire label would reduce protections for the
downstream user of the chemicals. Relatedly, Ameren commented that
prior approval should not be required for using the abbreviated labels
(Document ID 0309, p. 12). To clarify, new paragraph (f)(12) would not
require prior approval, only that the company must demonstrate that the
full label was infeasible.
HCPA's comment supported the agency's efforts, but requested that
OSHA follow the approach of Canada, which does not require entire label
elements on the outer package (Document ID 0327, pp. 5-6). OSHA
believes that not having this information on the immediate outer
package would be a reduction in protections that the HCS currently
affords and removing this information would not provide any benefits
other than aligning with Canada. While OSHA strives to align
with Canada where possible, OSHA's primary mission is to protect
workers. OSHA believes providing the full label on the immediate outer
package is appropriate and provides the workers downstream with the
information they need.
While not endorsing or disagreeing with the proposal, Epson asked
if OSHA would offer the same exemptions as the EU CLP regulation which
provides exemption for containers not exceeding 125 ml (Document ID
0288, p. 1). OSHA has chosen to provide labeling flexibility for
containers of 100 ml or less because OSHA believes that the information
on the immediate container is essential and the chemicals even in very
small containers can be extremely hazardous. OSHA's determination to
place the cut-off at 100 ml also aligns with Canada's small container
labeling requirements and therefore serves the important purpose of
consistency with our largest trading partner. Hach asked for the 3 ml
limit for very small containers to be raised to 5 ml and provided
photos in comments and testimony to demonstrate their concerns
(Document ID 0323, pp. 6-8; 0425, Tr. 83-84). OSHA believes, however,
that 3 ml is the appropriate cut-off for a total exemption of hazard
information. This cut-off is consistent with Canada's requirements for
small container labeling, and while Hach provided pictures of small
containers of less than 5 ml, there is no indication that a label would
interfere with the use of the product.
PLASTICS expressed concern about a ``mixed kit'' scenario, where an
outer package would contain smaller containers of varying sizes or
where some containers in a kit do not contain hazardous materials and
would not be covered by the HCS, and proposed alternate regulatory
language that would accommodate this type of situation (Document ID
0314, pp. 18-19). PLASTICS also requested that OSHA permit downstream
users to relabel containers in such a scenario. While OSHA acknowledges
that a ``mixed kit'' scenario might pose challenges in applying this
accommodation, OSHA does not believe that the appropriate response is
to move the responsibility of labeling the immediate container to the
downstream users. This would require each downstream user to open each
kit and figure out which container would need to be relabeled, creating
the potential for mislabeling. OSHA already provides multiple
flexibilities, including the use of attached tags which can be applied
to the immediate outer container for the full information. Rev. 8 shows
several different options on how to label ``kits'' in Annex 7 (example
10--scenario A and B) (Document ID 0065, pp. 451-457).
Toby Threet suggested regulatory text changes for proposed
paragraph (f)(12). Threet stated that any container less than or equal
to 3 ml capacity is automatically also less than or equal to 100 ml
capacity and label preparers cannot comply with both paragraphs
(f)(12)(ii) and (f)(12)(iii); therefore, OSHA should modify paragraph
(f)(12)(ii) to add a lower limit of ``greater than 3 ml'' (Document ID
0279, pp. 25-26). OSHA does not believe that this change is appropriate
because paragraphs (f)(12)(ii) and (f)(12)(iii) have separate
conditions that trigger their applicability; thus, there is no conflict
between the two provisions. Threet also requested that OSHA exclude
situations where the immediate outer container might itself present a
hazard, such as if it became contaminated with radiation (Document ID
0279, p. 26). In such a situation, the downstream user would have an
obligation to ensure appropriate labeling under paragraph (f)(9); the
agency does not believe it would be beneficial to complicate the
regulatory text here.
OSHA received one additional comment that was beyond the scope of
proposed changes related to paragraph (f). PLASTICS submitted a comment
relating specifically to (f)(6)(iii) that recommends using color-coded
charts to replace labels at workstations where solvents present an
issue with label integrity (Document ID 0357, pp. 3-4). This comment is
out of scope because it does not relate to any changes proposed in the
NPRM. OSHA notes that this issue has already been addressed in the 2015
HCS compliance directive (Document ID 0007).
For the reasons discussed above, OSHA is finalizing paragraph
(f)(12) of the rule as proposed.
PLASTICS and Vinyl Institute also asked OSHA to address the
difficulties associated with creating labels to meet the requirements
of multiple jurisdictions with inconsistent requirements even though
the manufacturer ``does not know where the product will be shipped at
the time it is packaged and labeled'' (Document ID 0314, Att. 1, p. 20;
0369, Att. 2, p. 10). PLASTICS and Vinyl Institute did not provide any
specific suggestions regarding how OSHA should address this issue. The
HCS has always differed in some respects from other jurisdictions that
adopt the GHS, and the GHS anticipates that countries will adopt the
GHS with slight variation, so OSHA does not believe this is a new issue
presented by the updates in this rulemaking. OSHA does not have control
over the requirements of other jurisdictions, but notes that many of
the changes in this final rule are designed to better align with other
jurisdictions to avoid issues with inconsistent requirements.
OSHA received two additional comments that are pertinent to
paragraph (f), but that are out of scope for this rulemaking. PLASTICS
requested that the agency codify the guidance in an LOI from November
23, 2015, that provides an exception for containers that are shipped to
destinations outside of the U.S. and sent directly overseas with no
anticipated exposures to downstream U.S. workers (Document ID 0314,
Att. 1, p. 20). Vinyl Institute also identified this as a change that
was missing from the proposals in the NPRM (Document ID 0369, Att. 2,
p. 10). OSHA did not propose to codify this LOI in the NPRM, therefore
this comment is outside the scope of this rulemaking and the agency
declines to take the requested action.
(g) Safety Data Sheets
Paragraph (g) specifies the requirements for chemical manufacturers
and importers to obtain or develop an SDS for each hazardous chemical
in the workplace. SDSs provide important safety information to
employers and employees on the use of hazardous chemicals in the
workplace. Additionally, SDSs provide detailed technical information
and serve as a reference for employees who are exposed to a hazardous
chemical, industrial hygienists, safety professionals, emergency
responders, health care professionals, and other interested parties.
This final rule revises paragraphs (g)(2), which identifies what
information must be included on an SDS, and (g)(10), which addresses
the form and storage of SDSs, and corrects erroneous references to
material safety data sheets in (g)(7).
The first sentence of paragraph (g)(2) previously stated that the
chemical manufacturer or importer preparing the SDS shall ensure that
it is in English. However, as permitted by paragraph (g)(1), some
chemical manufacturers and importers may obtain, rather than prepare,
SDSs. To minimize any potential confusion between paragraphs (g)(1) and
(2), OSHA proposed to revise paragraph (g)(2) by removing the reference
to preparing the SDS. The sentence as proposed reads ``The chemical
manufacturer or importer shall ensure that the safety data sheet is in
English . . . . ''. This is a technical clarification intended to
ensure consistency with paragraph (g)(1).
OSHA also changed the wording in the parenthetical at the end of
paragraph (g)(2) from ``Sec. 1910.1200-Safety Data Sheets'' to ``to
this section.'' OSHA received no comments on these proposed revision to
(g)(2); therefore, OSHA is finalizing (g)(2) as proposed.
OSHA also proposed a change to paragraph (g)(10) to allow SDSs to
be stored, rather than designed, in a way that covers groups of
hazardous chemicals in a work area. When the HCS was first promulgated
in 1983, paragraph (g)(10) permitted employers to design SDSs to cover
groups of hazardous chemicals in a work area where it may have been
more appropriate to address the hazards of a process rather than
addressing the hazards of each chemical individually (48 FR 53337).
In 2012, OSHA changed the SDS provisions of the HCS to require a
standardized 16-section format, which improved hazard communication by
ensuring users could quickly find relevant information (see 77 FR
17596-98). The standardized format requires each SDS to address a
single hazardous chemical rather than groups of hazardous chemicals.
Therefore, OSHA has proposed a change to paragraph (g)(10) that would
allow SDSs to be stored, rather than designed, in a way to cover groups
of hazardous chemicals in a work area. As OSHA explained in the NPRM,
the proposed change would allow employers flexibility in how they keep
SDSs in the workplace while also ensuring that the required SDS format
is maintained (86 FR 9700). The agency requested comments regarding
whether the proposed revision would require stakeholders to make any
significant changes to their current practices (86 FR 9688).
Several commenters expressed support for this proposed revision.
NAIMA supported the proposed revision, as SDSs must currently follow a
standard format (Document ID 0338, p. 8). NACD similarly observed that
the proposed revision ``makes sense as the HCS requires SDSs to use a
standard format'' and further noted that it would not require any major
changes to chemical distribution operations (Document ID 0329, p. 6).
Ameren also noted that the proposed revision would not require
significant changes to its current practices (Document ID 0309, p. 12).
In addition, NIOSH stated that it is unaware of any changes to current
practices that will be required by the proposed revision (Document ID
0281, p. 4; 0423, Tr. 19). OSHA received no comments or testimony
objecting to the proposed revision to (g)(10).
Several commenters requested clarification regarding the proposed
change to paragraph (g)(10). API asked for ``further clarification
about the storing language'' (Document ID 0316, p. 9). ACC asked if the
revision would allow electronic storage of SDSs, or merely allow
employers to group the SDSs together (Document ID 0347, p. 12). Dow
also asked for clarification on electronic storage, stating that they
``do not foresee an impact as long as OSHA can confirm that this change
will still allow for on-site back-up storage of SDS's while also
allowing employers to provide electronic access to employees''
(Document ID 0359, p. 4).
In response to API's request for clarification, OSHA notes that the
general intent of the change to (g)(10), as discussed in the NPRM and
reiterated above, is to allow the individual 16-section SDSs required
by the 2012 HCS to be stored in a way that covers groups of hazardous
chemicals in a work area (86 FR 9700). Because the HCS now requires an
individual SDS for each chemical, however, employers can no longer
``design'' SDSs that cover groups of hazardous chemicals. Following
publication of the final rule, OSHA will issue guidance materials and
respond to inquiries on any aspects of the HCS for which stakeholders
request information or clarification.
In response to questions regarding electronic storage, OSHA notes
that paragraph (g)(8) of the HCS, which requires the employer to
maintain copies of the required SDSs for each hazardous chemical and
make sure that they are readily accessible to employees when they are
in their work areas, specifically permits electronic access to SDSs
provided that such access poses no barriers to immediate employee
access. OSHA elaborated on this in the preamble to the 2012 HCS (77 FR
17729). OSHA's revision to (g)(10) does not change the requirements of
(g)(8); the HCS still allows employers to provide SDSs via electronic
access as long as employees have immediate access to the SDSs and
employers are able to immediately provide copies of SDSs to medical
personnel.
For the reasons discussed above, OSHA is finalizing paragraph
(g)(10) as proposed.
Additionally, OSHA is also correcting references to material safety
data sheets in (g)(7)(i), (iii), and (iv) which it identified after the
NPRM. In this final rule, OSHA is updating those references to reflect
the change to the terminology safety data sheets in the 2012 HCS.
Finally, OSHA received one out-of-scope comment regarding paragraph
(g)(4). TFI and ARA jointly commented that (g)(4) permits agricultural
retailers to create a single SDS for all custom fertilizer blends of
the same hazard classification, and asked OSHA to include a statement
in the preamble adopting this interpretation (Document ID 0340, pp. 4-
6).
Paragraph (g)(4) allows chemical importers, manufacturers and
retailers to prepare a single SDS where complex mixtures have similar
hazards and contents (i.e., the chemical ingredients are essentially
the same, but the specific composition varies from mixture to mixture).
Where a single SDS is used for similar mixtures or in cases of batch-
to-batch variability, concentration ranges of ingredients may be used.
If the composition differences are small, and the hazard(s) remain the
same, concentration ranges may be used for multiple, similar products;
however, separate SDSs are required for blends containing distinct
ingredients. TFI and ARA's comment is beyond the scope of this
rulemaking because OSHA did not propose any revisions to paragraph
(g)(4). In addition, as TFI and ARA noted in their comment, OSHA has
previously addressed this question in a letter of interpretation
requested by TFI. As stated in that letter, OSHA cannot provide a
blanket approval because the agency does not approve or endorse SDSs
(available at https://www.osha.gov/laws-regs/standardinterpretations/2016-02-25.)
(i) Trade Secrets
Paragraph (i) of the HCS describes certain conditions under which a
chemical manufacturer, importer, or employer may withhold the specific
chemical identity (e.g., chemical name), other specific identification
of a hazardous chemical, or the exact percentage (concentration) of the
substance in a mixture, from the SDS.
In the NPRM, OSHA proposed several changes to paragraph (i). First,
OSHA proposed to allow manufacturers, importers, and employers to
withhold a chemical's concentration range as a trade secret, which had
not previously been permitted, and to add language specifying that it
is Section 3 of the SDS from which trade secret information may be
withheld. Second, OSHA proposed to require the use of prescriptive
concentration ranges in lieu of the actual concentration or
concentration range whenever the actual concentration or concentration
range is claimed as a trade secret. These changes were proposed to
align with Canada's WHMIS, allowing manufacturers, importers, and
employers the ability to use the same SDS for both U.S. and Canadian
workplaces. The proposed
ranges are the same as those required by Canada (Document ID 0172).
Third, OSHA proposed to replace the phrase ``physician and nurse'' in
paragraph (i) with the term Physician or other licensed health care
professional (PLHCP), defined as an individual whose legally permitted
scope of practice (i.e., license, registration, or certification)
allows the individual to independently provide or be delegated the
responsibility to provide some or all of the health care services
referenced in paragraph (i) of the standard.
OSHA requested comments on the proposed changes to paragraph (i),
including information on stakeholders' experiences with developing SDSs
using the prescribed concentration ranges for compliance with Canada's
WHMIS and any concerns they might have about using concentration ranges
on the SDS. OSHA also requested comments on whether the proposed ranges
would provide sufficient information for downstream manufacturers to
conduct hazard classifications and whether the proposed ranges would be
too wide to provide sufficient information to protect workers.
Additionally, OSHA requested comments specific to proposed new
paragraph (i)(1)(v), which would require use of the narrowest
applicable concentration range, but in cases where the concentration
range to be withheld falls between 0.1 percent and 30 percent and does
not fit entirely into one of the prescribed concentration ranges, would
permit use of a single range created by the combination of two
applicable consecutive ranges instead, provided that the combined
concentration range does not include any range that falls entirely
outside the actual concentration range in which the ingredient is
present. OSHA requested comments on this proposal and on two
alternatives to the proposed provision: a more lenient version,
allowing combinations among all ranges up to 100 percent concentration,
and a more restrictive version, such as allowing combinations only for
the ranges up to 10 percent concentration.
Several commenters expressed general support for OSHA's proposal to
allow actual concentration ranges to be withheld as a trade secret and
to require the use of prescribed concentration ranges (Document ID
0316, p. 28; 0323, p. 9; 0329, p. 6; 0359, p. 4; 0361, pp. 2-3; 0363,
pp. 6-7; 0368, p. 12; 0425, Tr. 75-78). IMA-NA supported the trade
secret protections in the NPRM, stating that the proposed revisions
would provide necessary flexibility in the use of concentration ranges
for mixtures omitted from SDS disclosures and protect sensitive
information (Document ID 0363, pp. 6-7). NACD commented that the
prescription of ranges would improve accuracy of companies' hazard
assessments and reporting by introducing a standardized set of ranges
and reducing ``guesswork'' in the selection of an appropriate range and
would ease compliance with OSHA's PSM standard and the EPA's Risk
Management Program, (Document ID 0329, p. 6; 0423, Tr. 178-179). Dow
also supported the use of prescribed ranges to protect trade secrets,
stating that OSHA's proposal ``strikes a fair balance between
disclosure of information and worker protection'' (Document ID 0359, p.
4). NABTU strongly supported the proposed requirement of mandatory
concentration ranges (Document ID 0334, p. 4; 0425, Tr. 24-25).
Several commenters, including industrial entities or associations
such as Hach, NACD, Dow, and ACA, additionally supported the specific
ranges OSHA proposed, which align with those already in use by Health
Canada (Document ID 0323, p. 9; 0329, p. 8; 0359, p. 4; 0368, p. 12).
ACA noted that some ACA members already use the ranges prescribed by
Canada and have found that the ranges provide adequate information to
downstream users (Document ID 0368, p. 12).
OSHA also received comments critical of its proposal. Some
stakeholders argued that the proposed requirement would weaken
protections for CBI relative to the provisions of the 2012 HCS. Among
these, most suggested that OSHA should make the use of prescribed
concentration ranges optional for entities claiming the actual
concentration range as a trade secret (Document ID 0319, p. 2; 0321,
pp. 2-3; 0327, p. 6; 0343, p. 3; 0356, p. 4; 0343, p. 3; 0347, pp. 13-
14; 0366, p. 6; 0367, p. 3; 0369, p. 9; 0374, p. 2; 0424, Tr. 13; 0447,
pp. 4-5), while FCA favored maintaining the existing trade secret
provisions (Document ID 0345, p. 4). Several stated that the specific
ranges OSHA proposed would be too narrow to adequately protect CBI
(Document ID 0324, p. 4; 0345, p. 4; 0366, p. 6; 0367, p. 3; 0369, p.
9; 0468, pp. 3-4), or could be confusing because some of the ranges
overlap one another (Document ID 0345, p. 4) or cross some hazard
classification thresholds (Document ID 0347, p. 14; 0349, pp. 1-2;
0366, p. 6). Michele Sullivan commented that ranges which cross hazard
classification thresholds ``could also cause a conflict with the EU CLP
requirements'' (Document ID 0366, p. 6).
A few commenters stated that requiring the use of prescribed ranges
would be expensive and time-consuming for companies who would need to
program changes to their SDSs for use in the U.S. if claiming actual
concentration range as a trade secret (Document ID 0343, p. 3; 0347,
pp. 13-14); NAIMA, on the other hand, commented that it ``is not aware
of any economic implications associated with including the prescribed
concentration ranges so long as they are not so narrow as to
effectively annul the Trade Secret'' (Document ID 0338, p. 8). Others
argued that workers are adequately protected under the standard's
existing provision allowing medical professionals to obtain chemical
composition from the chemical manufacturer, importer, or employer in an
emergency, in addition to the standard's existing provisions for OSHA
and certain others to obtain it in some non-emergency situations
(Document ID 0366, p. 6; 0356, p. 4; 0337, p. 2; 0349, pp. 1-2). APA
commented that the previously existing HCS provisions for trade secrets
and medical personnel access to information are appropriate because
errors in judgment may occur if emergency responders opt to rely on
information from a prescribed range instead of contacting the
manufacturer to get an exact percentage (Document ID 0337, p. 2).
While most commenters who expressed concern about protection of CBI
or the potential costs of compliance did not give further information,
examples, or analysis to support their position, a few provided
additional explanation. ILMA noted that, because their products are
often customized, a requirement to provide concentration range
information could compromise CBI for their customers as well as
themselves, and that legal protections of CBI may be lost once a trade
secret is revealed through non-illicit means (Document ID 0356 p. 4;
0424, Tr. 120-121). ACC stated that the concentration of a substance
within a mixture could possibly be determined ``for example, if the
classification limit is close to one of the concentration cutoffs''
(Document ID 0347, p. 14). In their post-hearing comments, ACC provided
a hypothetical example: ``If there are 2-3 components in a solution one
at 95% and two at 2 and 3%, the 1 to 5% range could just be a few
competitor tests away from getting it right. . . [A] wide range
protects more'' (Document ID 0468, pp. 7-8). NAIMA's post-hearing
comment stated that ``For mixtures, any [range] less than 10 percent
would be too narrow.'' NAIMA also stated that the following ranges
``have been identified as . . . sufficient to protect trade secrets:
(a) 7 to 13%; (b) 10 to 30%; (c) 15 to
40%; (d) 30 to 60%; (e) 45 to 70%; (f) 60 to 80%; (g) 65 to 85%; (h) 80
to 100%; and 0-10%'' (Document ID 0461, p. 1).
Some commenters suggested that companies should be allowed to
design ranges appropriate to their CBI or other business needs
(Document ID 0319, p. 2; 0324, p. 4; 0345, p. 4; 0363, p. 6; 0366, p.
6; 0425, Tr. 24-25). For example, ICT commented that OSHA should permit
mixture manufacturers/importers to prepare SDSs with concentration
ranges that sufficiently protect their trade secrets (Document ID 0324,
p. 4) and FCA requested that manufacturers be allowed to utilize ranges
customary within their industry (Document ID 0345, p. 4). In addition,
several commenters suggested that OSHA should allow companies to select
ranges narrower than those OSHA proposed (Document ID 0299, pp. 2-3;
0309, pp. 13-16; 0321, p. 2; 0334, pp. 3-4; 0349, p. 1; 0359, p. 4;
0368, p. 12; 0425, Tr. 24-25, 35-36, 117-118; 0464, p. 6). Dow noted
that Health Canada's latest proposed revision to their HPR codifies a
similar allowance for smaller ranges that fit within the prescribed
ranges, so that adoption of a similar provision by OSHA would maintain
alignment with Canada (Document ID 0359, p. 4).\57\ Industrial Health
and Safety Consultants (IHSC) suggested that the issue of over-
classification (i.e., cases in which use of a prescribed range could
result in classifying a substance in an additional and/or higher hazard
category) could be alleviated by allowing the use of concentration
ranges narrower than those proposed (Document ID 0349, pp. 1-2).
PLASTICS asked whether a classifier would be required to classify a
product to reflect the most severe category into which the highest
point of a range selected to represent batch variability would fall
(Document ID 0314, p. 21).
---------------------------------------------------------------------------
\57\ Health Canada published the update to their HPR in December
2022. Their final rule includes the allowance for narrower ranges.
Canada Gazette, Part II, Volume 157, Number 1.
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NABTU supported permitting manufacturers and importers to use their
own concentration ranges if they are narrower than the prescribed
ranges (Document ID 0425, Tr. 24-25; see also Document ID 0334, p. 4;
0424, Tr. 35-36, 0464, p. 6).
NIOSH testified at the public hearing that ``non-mandatory use of
the prescribed concentration ranges . . . could weaken protection of
workers by downplaying the contribution of the chemical in question to
the hazards of the product'' (Document ID 0423, Tr. 20) and that the
prescribed concentration ranges ``will allow handlers of the materials
better protections and better hazard communication, as well as
emergency responders potentially dealing with a substance and having to
access that information readily'' (Document ID 0423, Tr. 31-32). NIOSH
also commented that allowing manufacturers to use their own
concentration ranges could result in ranges so broad as to be nearly
useless, providing the example of an SDS that listed a concentration
range from one-half of one percent to 50 percent (Document ID 0281, p.
6; 0423, Tr. 30-31, 47-48). NABTU echoed this concern, stating in post-
hearing comments, ``[t]he wide concentration ranges manufacturers are
currently listing on their SDSs make it more difficult to determine if
the use of a given product is likely to result in exposures above or
below levels considered to be safe'' (Document ID 0464, p. 6).
After considering all comments received on the agency's proposed
requirement to use prescribed ranges which align with those in use by
Health Canada, OSHA has decided to finalize the requirement to utilize
prescribed concentration ranges when claiming exact concentration as
proposed, with the exception that OSHA is adding a new paragraph
(i)(1)(vi). This new provision allows the use of narrower ranges than
those prescribed in (i)(1)(iv) and (i)(1)(v), meaning that the range
must be fully within the bounds of a prescribed range listed in
(i)(1)(iv) or fully within the bounds of a combination of ranges
allowed by (i)(1)(v). OSHA's responses to the concerns received
regarding proposed paragraph (i) are given below.
First, OSHA is not persuaded that requiring the use of prescribed
ranges, or the specific ranges the agency proposed, would significantly
compromise CBI. The trade secret provisions of the HCS do not rely only
on withholding of concentration information in order to protect CBI,
but also allow the manufacturer or supplier to claim the chemical
identity as CBI (paragraph (i)(1)). In addition, OSHA does not require
listing the chemical's generic chemical identity or alternative name
(e.g., ``Alcohol'' for propanol vs. ``Component 1''), which provides
additional CBI protection. And, while several commenters opined that
required use of the ranges OSHA proposed could compromise CBI, none
provided persuasive information, argument, or analysis to support their
concerns or preferred alternative. While NAIMA provided alternate
ranges for OSHA's consideration in post-hearing comments, which they
said, ``have been identified as . . . sufficient to protect trade
secrets,'' this statement is not supported by the source NAIMA cites.
That source is a document summarizing the thirteen prescribed
concentration ranges included in Canada's 2015 update to the HPR for
use in protecting trade secrets. These ranges include the ranges (a)
0.1 to 1 percent; (b) 0.5 to 1.5 percent; and (c) 1 to 5 percent, which
are not included in the set of ranges NAIMA gave when citing the
summary document. They do not include the range 0-10 percent, which was
included in NAIMA's post-hearing comment citing the document. NAIMA's
statement that the ranges it listed ``have been identified'' as
protective of CBI therefore does not accurately reflect the content of
the source it cited; rather, that source refers to the prescribed
ranges that Canada adopted and that OSHA proposed in the NPRM (Document
ID 0461, p. 2).
Furthermore, OSHA's proposed ranges have been in use by entities
trading in Canada since 1988 (previously under WHMIS 1988 and then
reinstated under the HPR in 2018), yet no commenter provided a real-
world example of CBI compromised due to the use of Canada's prescribed
ranges. Notably, ACA stated that some of its members already use the
ranges prescribed by Canada and have found they provide adequate
information to downstream users (Document ID 0368, p. 12); ACA did not
report that using the prescribed ranges compromised any of their
members' trade secrets. NACD commented that individuals involved in the
commercial and sales aspects of chemical distribution ``reported no
concerns that the prescribed ranges would inadvertently disclose trade
secret information'' (Document ID 0329, p. 6; 0423, Tr. 178-179). API
stated it had no concerns with the proposed change (Document ID 0316,
pp. 10, 28). And, as previously noted, OSHA received comments from
several industrial entities or associations including Hach, NACD, Dow,
and ACA, specifically supporting the requirement to use the ranges used
by Health Canada (Document ID 0323, p. 9; 0329, p. 8; 0359, p. 4; 0368,
p. 12).
After consideration of the comments received on possible compromise
of CBI, OSHA finds that these commenters have not adequately supported
their position that the proposed requirement to use prescribed
concentration ranges would significantly compromise CBI. OSHA is also
not persuaded that paragraph (i) should include broader ranges than
those proposed or allow companies flexibility to design ranges
broader than those proposed. Creating broader ranges would be less
informative to workers and other downstream users, and would negate the
benefit of consistency with Canada's system. However, OSHA notes in
response to PLASTICS that classifiers would be required to classify a
substance according to the most severe hazard associated with the range
they select, and agrees with comments that allowing the use of narrower
concentration ranges than those prescribed would alleviate some of the
classification concerns raised by stakeholders without compromising the
information provided to workers and other users. Therefore, OSHA is
adding a new paragraph (i)(1)(vi) which states that the SDS preparer
may provide a range narrower than those prescribed in (i)(1)(iv) or
(i)(1)(v). This means that the range selected must be fully contained
within the range or combination of ranges required under (i)(1)(iv) and
(i)(1)(v), inclusive of the boundaries of such ranges. For example,
when the ingredient's concentration range in the mixture is 0.9 to 2
percent and that range is claimed as CBI, paragraph (i) as proposed
would have required the manufacturer or supplier to give the range 0.5
to 5 percent (a combination of the prescribed ranges 0.5 to 1.5 percent
and 1 to 5 percent). The revision to the proposed text allows the
manufacturer or supplier to disclose a narrower range such as 0.5 to 2
percent, or 0.9 to 5 percent, or 0.5 to 2.5 percent. If a manufacturer
or supplier finds that the concentration range they intend to claim as
a trade secret is below a certain hazard classification/category
threshold but using a prescribed range (or allowable combination of
prescribed ranges) would trigger other requirements (e.g., shipping,
storage) which would not have been triggered by the actual
concentration range, they may use a narrower range or combination of
ranges to avoid this issue. The allowance for the use of narrower
concentration ranges that fall within the prescribed ranges aligns with
Canada's WHMIS (Document ID 0172).
OSHA also disagrees with commenters who stated that requiring the
use of prescribed concentration ranges would provide no benefit to
workers beyond the existing provisions pertaining to medical emergency
situations, which allow medical professionals to obtain chemical
composition from the chemical manufacturer, importer, or employer in
the event of a medical emergency. OSHA has determined that providing
ready access to information about the concentration range of hazardous
substances to workers and other users is also essential to the purposes
of the HCS when such ranges are claimed as trade secrets. Workers have
a right to know, and to be able to readily access, information about
the nature and extent of their occupational exposures to hazardous
substances for their own information, records, and use--for example, in
the event that health concerns arise that may be work-related. In
addition, OSHA believes that emergency responders will benefit from
ready access to the prescribed concentration range of a hazardous
substance, particularly in cases where it may not be possible to
achieve immediate contact with the producer. Furthermore, the use of
prescribed ranges will help employers and other users to appropriately
assess risk in the workplace, even before an emergency arises. This
requirement provides information to help manage risk proactively.
Some commenters objected that OSHA's proposed changes to paragraph
(i) would not sufficiently inform workers regarding hazardous materials
in the workplace (Document ID 0268; 0299, pp. 2-3; 0341, pp. 38-39;
0354, p. 1, 0354, p. 6, 0356, p. 6). National COSH and Worksafe jointly
commented that the proposal would increase uncertainty for workers as
well as for regulators, employers, worker representatives and other
decision-makers (Document ID 0354). In contrast, NABTU found the
proposed approach to be an acceptable alternative to the current
standard as the prescribed concentration ranges ``would at least
provide some information [about] concentration in every instance of the
trade secret claim'' (Document ID 0425, Tr. 24-25). NIOSH stated that
the proposed change would not increase risk to workers provided that
the trade secret exemption is applied only in limited and specific
situations, and that complete information on hazardous properties,
special handling requirements, and necessary PPE is provided on the SDS
(Document ID 0281, p. 4; 0423, Tr. 19-20).
OSHA disagrees with comments that the proposed revisions to
paragraph (i) would lessen protections and/or information for workers.
Under paragraph (i), there are three types of information that
manufacturers can claim as a trade secret: the name of a chemical, the
exact percentage of a chemical's concentration in a mixture, and/or a
concentration range. In the 2012 HCS, OSHA allowed manufacturers to
completely withhold the name and/or the exact percentage; manufacturers
who withheld a chemical's exact percentage were not required to list a
concentration range in its place. Under this final rule, manufacturers
may no longer completely withhold the exact percentage; they must now
provide a concentration range in its place. This change will result in
additional information available to workers.
The Work Health and Survival Project (WHSP) and an anonymous
commenter suggested that OSHA should adopt the trade secret policies of
Australia's Work Health and Safety (WHS) regulation, in which the
identities of chemicals presenting moderate hazards may be withheld as
trade secrets on the SDS and disclosed using a generic name (Document
ID 0341, pp. 38-39; 0268). A different anonymous commenter, who claimed
to have experience with companies that make insufficiently supported
trade secret claims as a pretext for withholding the identity or
percentage of hazardous ingredients, opined that OSHA's proposal to
allow the concentration range to be withheld as a trade secret would
make it more difficult for downstream users to conduct hazard
classifications, and that ``the inappropriate claiming of trade secret
status should be addressed before companies are allowed to also claim
the range as a trade secret'' (Document ID 0308, p. 1). They suggested
that the HCS should not allow ``chemical ingredients of public
knowledge or of general knowledge in an industry'' to be claimed as a
trade secret.
OSHA did not propose to require the use of a generic name when the
identity of chemicals presenting moderate hazards are withheld as trade
secrets or to disallow trade secret protection for generally known
chemical components. These suggestions are therefore out of scope for
this rulemaking. For OSHA to consider these changes they would need to
be addressed in a future rulemaking. Furthermore, OSHA does not agree
that the proposal to allow concentration ranges to be withheld as a
trade secret must not be finalized until the possibility that some
manufacturers may be using the trade secret provisions inappropriately
is eliminated. OSHA believes that potential misuse of trade secret
protections is best addressed through enforcement.
Several commenters gave input on the proposed rules for combining
ranges, including responses to the question OSHA posed in the NPRM as
to whether it should allow more expansive combination of the prescribed
ranges. NAIMA and Ameren supported combination of all ranges listed
(Document ID 0309, p. 13; 0338, p. 8; 0423, Tr. 162-163). Ameren cited
``potential cost savings by OSHA allowing combinations among all
ranges'' (Document ID 0309, p. 13).
DOD opposed allowance for combinations of all prescribed ranges,
arguing that the benefits to be gained by requiring use of prescribed
ranges would be negated by allowing combination of an unlimited number
of concentration ranges. DOD recommended instead that OSHA should
``allow no more than 2 prescribed concentration ranges, below 20%, to
be combined as this would still provide actionable information for
managers and safety professionals to protect worker health'' and that
the use of any concentration range greater than 20% (or combined
concentration ranges greater than 20%) should require some form of
special exemption (Document ID 0299, pp. 2-3).
OSHA agrees with DOD that allowing employers to combine prescribed
ranges from (i)(1)(iv)(A) through (M) would prevent important
information from reaching employees and health and safety
professionals. However, OSHA does not agree that limiting concentration
ranges to no greater than 20% will materially improve the effectiveness
of the standard over the concentration ranges OSHA proposed. Most of
the concentration ranges OSHA proposed to adopt in paragraph (i)(1)(iv)
are 25% or less, with the exception of paragraph (i)(1)(iv)(I)
(concentrations between 30% and 60%). The largest range that could be
created through combining ranges is 23% (for concentrations of 7% to
30%). As explained above, the ranges chosen have been in use by
entities trading in Canada since 1988 and OSHA finds no evidence in the
record, or in DOD's comment, demonstrating that these ranges are
insufficient to effectively inform workers and downstream users of
chemical hazards. In addition, altering the concentration ranges would
negate the benefit of consistency with Canada's system. Therefore, OSHA
is not adopting DOD's suggestion.
PLASTICS asked OSHA to clarify what is required if the actual
concentration range straddles two prescribed ranges, in two situations.
First, PLASTICS stated that the proposal ``does not clearly convey the
options available if the exact range falls between 0.1% and 30% and
does not fit entirely into one of the prescribed ranges.'' Second,
PLASTICS asked for clarification on what should be done if the actual
concentration range straddles two prescribed ranges and it exceeds 30%.
PLASTICS proposed the following revision to address these situations:
``[w]hen the concentration or concentration range for an ingredient is
withheld as a trade secret, the SDS must list the narrowest prescribed
concentration range(s) in Sec. 1910.1200(i)(1)(iv) which include(s)
the actual concentration or concentration range for that ingredient''
(Document ID 0314, p. 21; see also 0423, Tr. 142-143).
OSHA disagrees with PLASTICS' suggestion. First, OSHA believes
proposed paragraph (i)(1)(v) does clearly specify what a manufacturer
must do when the exact range falls between 0.1 and 30 percent but does
not fit entirely into one of the prescribed ranges (A) through (G). In
that case, the manufacturer must combine two consecutive ranges between
(A) and (G) and may supply the resulting range in place of selecting a
single prescribed range to represent the concentration range on the
SDS.
Regarding PLASTICS' question as to what should be done when a
concentration range above 30 percent cannot be captured by the use of a
single prescribed range, OSHA believes in such a circumstance it would
be inappropriate for a manufacturer to withhold the concentration range
from the SDS. In the hypothetical case where representing a
manufacturer's batch would require a combination of ranges above 30
percent, the resulting range would generally be too wide to provide
meaningful information to workers, and permitting such combinations
would bring the HCS out of alignment with Canada. Therefore, OSHA is
not adopting PLASTICS' proposed revision. OSHA notes that manufacturers
would still, in such cases, have the option of withholding the chemical
identity in order to protect trade secret information.
ADM similarly suggested that OSHA revise paragraph (i) ``to clarify
that any of the prescriptive concentration ranges be allowed, if
accurate'' (Document ID 0361, p. 3). OSHA notes that ADM's requested
change would contradict, rather than clarify, the agency's intent.
Manufacturers must use the narrowest range possible that includes the
true concentration range, so that workers will have access to the most
precise information possible under a system of prescribed ranges which
align with Health Canada's requirements.
For the reasons discussed above, OSHA is finalizing the rules for
combination of prescribed ranges as proposed, with the exception that
OSHA has added paragraph (i)(1)(vi) to allow use of narrower ranges,
and narrower combinations of ranges, than those described in (i)(1)(iv)
and (i)(1)(v) respectively.
PLASTICS also suggested revising (i)(1) to state that the chemical
manufacturer, importer, or employer may withhold the chemical identity
and/or concentration or concentration range of a hazardous chemical
``substance . . . from Section 3 (as well as every other section) of
the safety data sheet . . .'' (emphasis added to indicate PLASTICS'
suggested additions to (i)(1)) (Document ID 0314, p. 20). PLASTICS
opined that the reference to Section 3 in paragraph (i)(1) ``could
imply that it must still be included elsewhere'' on the SDS.
OSHA does not believe that PLASTICS' suggested text is necessary or
appropriate. OSHA intended the instructions contained in paragraph
(i)(1) to pertain to how to treat chemical trade secrets for Section 3
of the SDS. This is evident in OSHA's HCS Compliance Directive, which
specifies that if a trade secret is claimed, the SDS must indicate that
the identity and/or concentration of the chemical is claimed as a trade
secret in Section 3 (Document ID 0007, pp. 76-77). OSHA proposed to add
``in Section 3'' to paragraph (i)(1) to ensure that its intent for the
directions contained in paragraph (i)(1) to apply specifically to the
SDS Section 3 is clear. However, OSHA did not intend for this
clarification to imply that a manufacturer who withholds the identity
of a hazardous chemical from Section 3 in accordance with paragraph (i)
must provide the name of that chemical in other sections, such as in
conjunction with its OSHA Permissible Exposure Limit (PEL) or American
Conference of Governmental Industrial Hygienists (ACGIH) Threshold
Limit Value (TLV) (if applicable) in Section 8. Rather, the identifier
provided for that chemical in Section 3 should be used consistently
throughout the SDS. This is also conveyed by the directive, which
indicates that the identifier used in Section 3 and Section 8 must be
the same if there is a PEL or TLV associated with the constituent. In
addition to the requirement to use a single identifier for a hazardous
chemical throughout the SDS, OSHA notes that in other sections where a
manufacturer may make specific claims about a chemical constituent's
health effects and provides supporting evidence for those claims (e.g.,
Section 11, Toxicological information) the manufacturer must provide
sufficient information regarding the chemical identity for others to
assess these claims.
Furthermore, OSHA notes that PLASTICS does not explain the addition
of ``substance'' in its suggested text. The agency finds that adding
``substance'' in the place indicated does not improve on
the original text and is not making this change to the regulatory text.
Toby Threet was concerned that if a range is broader than OSHA's
specified `` `trade secret' ranges, but . . . not being withheld as a
trade secret . . . an Agency inspector [may] misunderstand and issue a
citation, believing that these broad ranges did not comply with
paragraphs (i)(1)(iv) and (i)(1)(v).'' Threet requested ``clarification
from OSHA that the provisions of paragraphs (i)(1)(iv) and (i)(1)(v)
apply only to concentration ranges that are withheld as a trade secret,
not to actual concentration ranges that are disclosed in the SDS. Thus,
if the actual concentration range is broader than the ranges stated in
paragraph (i), and is disclosed, this does not constitute noncompliance
with paragraph (i)'' (Document ID 0279, p. 7). OSHA does not believe
this to be an issue because paragraphs (i)(1)(iv)-(v) unambiguously
apply only to trade secret claims and paragraph (i)(1)(iii) requires
the SDS to indicate when the specific chemical identity and/or
percentage concentration or concentration range of composition is being
withheld as a trade secret. Moreover, OSHA expects that its inspectors
will be adequately trained in the proper application of the standard's
requirements. Therefore, OSHA does not believe there will be any
confusion on this point and is not adopting Threet's suggestion.
As explained in the Summary and Explanation for paragraph (c), OSHA
proposed in the NPRM to add a definition of Physician or other licensed
health care professional (PLHCP) to the standard, defined as an
individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows the individual to independently
provide or be delegated the responsibility to provide some or all of
the health care services referenced in paragraph (i) of the standard.
Correspondingly, OSHA proposed to replace the phrase ``physician and
nurse'' in paragraph (i) with ``PLHCP'' to be consistent with other
OSHA standards that use the term PLHCP and to better reflect current
medical practices. No commenter objected to this revision.
In their comments and at the public hearing, PLASTICS requested
guidance on what measures an employer may take prior to disclosing a
trade secret in the event of a medical emergency to verify it would be
disclosed to an appropriate individual (Document ID 0314, p. 21; 0423,
Tr. 142-143). Paragraph (i)(2) specifies that where a treating PLHCP
determines that a medical emergency exists and the chemical identity
and/or specific percentage concentration of a hazardous chemical is
needed for emergency or first-aid treatment, the chemical manufacturer,
importer, or employer must immediately disclose the specific chemical
identity or percentage composition of a trade secret chemical to that
treating PLHCP, regardless of whether a written statement of need or a
confidentiality agreement exists. However, the chemical manufacturer,
importer, or employer may require a written statement of need and
confidentiality agreement, in accordance with the provisions of
paragraphs (i)(3) and (4), as soon as circumstances allow. The
confidentiality agreement authorized by paragraph (i)(3)(iv) provides
remedies to ensure CBI is protected.
Finally, PLASTICS and Michele Sullivan expressed concern that the
use of ``or'' in paragraph (i)(1) could suggest that either the
identity or the concentration of an ingredient may be withheld as CBI,
but not both. (Document ID 0314, pp. 20-21; 0366, p. 5). OSHA's intent
is that both chemical identity and the exact percentage (or the
concentration range) may be claimed as a trade secret. To clarify this,
and to be consistent with similar language in paragraph (i)(1)(iii),
OSHA has revised paragraph (i)(1) in the final rule to state that the
manufacturer, importer, or employer may withhold the specific chemical
identity and/or the exact percentage (concentration) or concentration
range of the chemical for which a trade secret is claimed.
(j) Dates
Paragraph (j) of the HCS specifies the dates by which compliance
with the updated provisions of the HCS is required. This final rule
modifies the previous dates in paragraph (j), which pertained to
implementation of the 2012 update to the HCS and have all passed. As
explained below, OSHA has modified the compliance dates in the final
rule from those proposed in the NPRM to address stakeholders' concerns
that the proposed dates did not provide sufficient time for chemical
manufacturers, importers, and distributors to comply.
In the NPRM, OSHA proposed a two-year tiered compliance period.
First, OSHA proposed that the final rule would become effective 60 days
after the publication date (paragraph (j)(1)). The agency then proposed
two staggered compliance dates: chemical manufacturers, importers, and
distributors evaluating substances would be required to comply with all
modified provisions of the HCS no later than one year after the
effective date (paragraph (j)(2)) and chemical manufacturers,
importers, and distributors evaluating mixtures would need to comply no
later than two years after the effective date (paragraph (j)(3)) (86 FR
9701).
OSHA received numerous comments on the proposed dates in paragraph
(j), including requests for extension of compliance dates; comments
related to the proposed differentiation between compliance dates for
substances and mixtures; and requests for clarification.
Two commenters stated that they believed the proposed compliance
dates were adequate (Document IDs 0309, p. 17; 0360, p. 9). Many
commenters, however, requested more time to comply with the proposed
changes to the HCS. Suggestions included extension of compliance dates
ranging from an additional six months to two years for substances and
six months to three years for mixtures (see, e.g., Document ID 0347,
pp. 14-16; 0423, Tr. 106; 0327, pp. 2-3; 0329, pp. 9-10; 0343, p. 4;
0349, pp. 2-3; 0338, pp. 5; 0461, pp. 3-5; 0368, p. 10; 0323, p. 10;
0367, p. 6; 0447, p. 6; 0291, pp. 2-4; 0356, p. 11; 0339, p. 4; 0316,
p. 11; 0364, p. 3; 0283, p. 6). Commenters based these recommendations
on a number of considerations related to the difficulty of updating
labels and SDSs. For example, ACC stated that a significant number of
the proposed changes to the HCS would either require updating a large
number of SDSs, such as the requirement to list particle
characteristics, or would require extensive time to implement properly
due to the need to purchase new software, test and approve changes to
software, and update precautionary statements on SDSs (Document ID
0347, pp. 15-17). NAIMA noted additional reasons that updating labels
and SDSs would be time-consuming, including the time required to
replace language or change color on a product label; review the changes
for quality, accuracy, and compliance with all regulatory requirements;
and redesign the labels (Document ID 0338, pp. 4-5; 0461, pp. 3-5).
Several commenters expressed support for OSHA's proposed tiered
approach which provided a later compliance date for chemical
manufacturers, importers, and distributors responsible for evaluating
mixtures than for those evaluating substances (See, e.g., Document ID
0323, p. 10; 0327, p. 2; 0356, p. 10; 0366, p. 6; 0367, p. 6; 0447, p.
6; 0347, p. 14; 0287, p. 12; 0309, p. 17; 0316, p. 11). However, some
commenters expressed concern that the compliance windows were too short
because downstream
users might not receive key information from upstream manufacturers,
importers, or distributors in time to comply with the requirement to
update SDSs or labels (See, e.g., Document ID 0327, pp. 2-3; 0329, p.
10; 0356, p. 10; 0317, p. 2; 0314, pp. 22-23; 0338, pp. 3-5; 0323, p.
10; 0287, p. 11; 0362, pp. 4-5). The National Association of
Manufacturers (NAM) noted that many downstream manufacturers,
importers, or distributors may not know whether there are any updates
in classification coming from upstream (Document ID 0362, pp. 4-5).
Hach echoed this concern, stating that this issue had previously caused
problems with OSHA's 2012 update to the HCS (Document ID 0323, p. 10).
Hach suggested that OSHA extend the compliance deadline for chemical
manufacturers of mixtures to two years beyond the compliance date for
substances (Document ID 0323, p. 10).
For similar reasons, some commenters recommended adding an
additional tier for chemical manufacturers who combine multiple
mixtures since they will be reliant on upstream manufacturers,
importers, or distributors for new information, which may come at the
end of the compliance period for the mixture tier (Document ID 0317, p.
2; 0362, pp. 4-5; 0326, p. 8). NAM and NRI recommended that in this
potential third tier OSHA should explicitly state that such companies
are allowed three months to update SDSs and six months to update labels
from the date the companies receive new information from upstream
suppliers (Document ID 0362, p. 5; 0326, p. 8). NACD proposed a
slightly different change to the tiered compliance dates and requested
that OSHA adopt a staggered implementation timeline based on role in
the supply chain, where the original chemical producer would have 18
months to comply, and the next segment of the supply chain (typically
chemical distributors) would have an additional year (Document ID 0329,
pp. 9-10).
As the following discussion explains, OSHA believes that the
proposed compliance dates will be adequate for implementation of most
of the HCS revisions included in this final rule. However, OSHA is
adopting a modest extension to the proposed compliance dates to account
for the possibility that some of the issues cited by stakeholders could
present a significant challenge to meeting the proposed timeline.
As discussed further in Section VI., Final Economic Analysis and
Regulatory Flexibility Analysis, OSHA has analyzed the time, effort,
and cost of the changes in this rule and has concluded that most of the
revisions will require only limited changes to SDSs and labels for
select hazardous chemicals to reflect chemical reclassifications
(Appendix B) and to conform to language criteria in precautionary
statements and other mandatory language (Appendix C and Appendix D). As
also noted in that section, chemical manufacturers and importers
periodically review, revise, and update the electronic templates they
use to create SDSs and labels when new information becomes available,
changes are made to the product, or new products are introduced to the
market, allowing many chemical manufacturers and importers to phase in
any required revisions to their labels and SDSs in accordance with the
normal cycle of updating these items. The arguments raised by
commenters were accounted for in that analysis. Therefore, the agency
estimates that the revisions it is finalizing will, for the most part,
be possible to work into the normal cycle of SDS and label updates.
Although OSHA believes that the proposed one- to two-year tiered
compliance dates will accommodate implementation of most revisions
included in this final rule, the agency also recognizes that some of
the changes to the HCS in this update will result in major changes to
classifications, and that some of the changes to Appendix C and
Appendix D may result in significant changes to some labels or SDSs,
which could pose difficulties for some stakeholders to meet the
compliance dates originally proposed. Therefore, OSHA is extending the
compliance date for chemical manufacturers, importers, and distributors
evaluating substances to be 18 months after the publication date and
the compliance date for mixtures to be 36 months after the publication
date. OSHA is amending the designation of the compliance date for
substances to be paragraph (j)(2)(i) and is amending the designation of
the compliance date for mixtures to be paragraph (j)(3)(i) in order to
accommodate the addition of paragraphs (j)(2)(ii) and (j)(3)(ii),
discussed later in this section. OSHA is not further differentiating
the compliance timeline between manufacturers of mixtures from
substances and manufacturers of mixtures from mixtures, as some
commenters suggested. Nor is OSHA adopting a staggered implementation
timeline based on role in the supply chain, as NACD suggested. OSHA is
concerned that adding such additional tiers could potentially create a
very long compliance timeline, leaving workers along the supply chain
with uneven protections and undermining the purpose of the HCS, which
is to have a single harmonized system. As the agency explained in
finalizing the 2012 HCS, although some overlap between the current
requirements and the new ones is inevitable during the phase-in period,
``hazard communication during this transition period will be confusing
and less effective'' (77 FR 17739). OSHA seeks to limit this effect by
ensuring that the transition is completed in a timely fashion.
OSHA has determined that the changes in this final rule can be
implemented within the timeframes set for compliance. OSHA believes
that the extended dates and tiered approach based on substances and
mixtures will alleviate the vast majority of compliance issues.
However, OSHA recommends that manufacturers of mixtures and downstream
clients who use their products for further processing and/or
manufacture of other mixtures work together to ensure that all parties
have sufficient time to comply with this standard. OSHA believes, as it
did in 2012, that ``[t]hese types of issues are generally addressed by
the market, and the needs of a manufacturer's customers'' (77 FR
17739). In addition, where particular circumstances warrant special
consideration (such as where a downstream user has not received the
necessary information despite its best efforts), OSHA retains
enforcement discretion to address those situations as appropriate.
Hach and ACA also requested an unlimited sell-through period for
products labeled prior to the compliance deadlines to prevent waste and
unnecessary compliance burden (Document IDs 0323, p. 10; 0368, p. 10).
Hach noted that ``[e]xisting label stock would cover thousands of
products. Without an unlimited sell-through these existing stocks would
need to be disposed of and manufactured products would need to be
relabeled'' (Document ID 0323, p. 10). While OSHA is not specifically
providing unlimited time to use already-created labels on existing
stock, the agency is finalizing an update to paragraph (f)(11) which
allows manufacturers, importers, and distributors to not relabel
chemicals that have been released for shipment and are awaiting
distribution, which will reduce the need to dispose of existing label
stock and eliminate relabeling for those products. See the Summary and
Explanation for paragraph (f) for further discussion of the update to
paragraph (f)(11).
Several commenters recommended that the compliance dates should
align
with other countries (Document ID 0279, p. 2; 0327, p. 2; 0347, p. 15;
0359, p. 5). In particular, HCPA, Dow, and ACC recommended that OSHA
coordinate compliance dates with Health Canada's WHMIS update (Document
ID 0347, p. 15; 0327, p. 2). OSHA notes that Health Canada has already
published their update to the HPR and they are now aligned with Rev. 7
(see https://www.canada.ca/en/health-canada/services/environmental-workplace-health/occupational-health-safety/workplace-hazardous-materials-information-system/amendments-hazardous-products-regulations.html) with a compliance date of December 14, 2025. The
agency will, however, work with Canada to address stakeholder concerns
regarding the timing of updates and related compliance dates as OSHA
has done with other cross-cutting issues. Additionally, OSHA notes that
chemical manufacturers have the option to coordinate their compliance
with Canada and OSHA's updated requirements by coming into compliance
with whichever country's compliance dates occur first.
OSHA also received requests for clarification related to the
proposed compliance deadlines. ICBA, NRI, AF&PA and AWC, and ILMA
stated that the terms ``evaluating substances'' and ``evaluating
mixtures'' in proposed paragraphs (j)(2) and (j)(3) were unclear
(Document ID 0291, pp. 2-4; 0356, p. 10; 0326, pp. 7-9; 0287, p. 10).
ICBA noted that if OSHA meant the term ``evaluating'' to refer only to
the task of hazard classification, the proposed regulation is unclear
as to when manufacturers, importers, or distributors must comply with
other new or revised requirements in this final rule, particularly
those that normally occur after a determination of a hazard
classification, as no other compliance dates were provided (Document ID
0291, p. 3). ICBA, ILMA, and AF&PA and AWC sought to clarify which
provisions of the final rule have a compliance deadline of 60 days, one
year, and two years after the effective date of the final rule
(Document ID 0291, p. 3; 0356, p. 10; 0287, p. 10). Relatedly, ASSP
raised concerns about the sufficiency of the compliance periods for
training requirements specifically, and recommended that OSHA implement
a transition period to allow employers adequate time to retrain workers
(Document ID 0284, p. 2).
OSHA intends that the terms ``evaluating substances'' and
``evaluating mixtures'' include hazard evaluations and updates to
classification, labeling, and SDSs required to comply with the
revisions in this final rule. These changes are to be completed by 18
months from the effective date for substances (paragraph (j)(2)(i)) and
by 36 months from the effective date for mixtures (paragraph
(j)(3)(i)). Because this final rule contains only limited revisions of
the hazard classification rules, the agency does not anticipate that
most employers will need to complete additional requirements that
follow from changes to hazard classification, namely, updating any
alternative workplace labeling used under paragraph (f)(6), updating
the hazard communication program required by paragraph (h)(1), and
providing any additional employee training in accordance with paragraph
(h)(3) for newly identified hazards. However, recognizing that some
employers will need to complete these requirements, OSHA is adding new
paragraphs (j)(2)(ii) and (j)(3)(ii) to the final rule. Those
paragraphs provide an additional six months after the compliance dates
to complete any necessary updates to alternative workplace labeling,
updates to the hazard communication program, and additional employee
training for newly identified physical or health hazards resulting from
evaluation of substances and mixtures (that is, 24 months after the
effective date for substances and 42 months after the effective date
for mixtures).
None of the provisions revised in this final rule have an immediate
compliance deadline on the effective date of the final rule (i.e., 60
days after the date of publication of the final rule). To further
clarify how employers can comply with the HCS through the
implementation phase of the final rule, OSHA is adding a new paragraph
(j)(4), which provides that chemical manufacturers, importers,
distributors, and employers may comply with either Sec. 1910.1200
revised as of May 20, 2024, or the previous version of this standard,
or both during the transition period.
In conclusion, for the reasons discussed above, OSHA is finalizing
paragraph (j) with the following modifications: chemical manufacturers,
importers, and distributors evaluating substances are required to
comply with all modified provisions of the HCS no later than 18 months
after the effective date (paragraph (j)(2)(i)) and those entities
evaluating mixtures must comply with all modified provisions no later
than 36 months after the effective date (paragraph (j)(3)(i)); new
paragraphs (j)(2)(ii) and (j)(3)(ii) require employers to update any
alternative workplace labeling under paragraph (f)(6), update the
hazard communication program required by paragraph (h)(1), and provide
any additional employee training in accordance with paragraph (h)(3)
for newly identified hazards no later than 24 months following the
effective date for substances and 42 months following the effective
date for mixtures; and new paragraph (j)(4) provides that chemical
manufacturers, importers, distributors, and employers may comply with
either the previous version of this standard, the version finalized in
this rule, or both during the transition period. The revised paragraph
(j) will replace the regulatory text previously included in paragraph
(j).
C. Appendix A
Appendix A addresses the health hazards covered by the HCS,
including classification criteria consistent with the GHS.
OSHA proposed to update Appendix A in several respects. The
agency's finalized changes to Appendix A, its review of the comments
and testimony received on the proposed changes to Appendix A, and
OSHA's response to these comments and testimony are discussed in order
of revisions to specific health hazards in Appendix A, followed by
general changes to definitions and terminology, clarification of
mandatory requirements, and corrections.
At the time that OSHA's NPRM was published, OSHA provided a redline
strikeout version of Appendix A, which reflected all of OSHA's proposed
revisions, in the docket and on the OSHA website (Document ID 0222, pp.
39-115) so that interested parties could view all of the proposed
changes in context. OSHA will update this document to show the changes
being made in this final rule and strongly encourages stakeholders to
review that document in conjunction with the discussion of the
revisions, as the discussion provided in this final rule's Summary and
Explanation does not fully describe all of the non-substantive or
editorial changes OSHA is making in Appendix A. Stakeholders can
examine the redline strikeout of the regulatory text (changes from 2012
HCS to this final) at OSHA's HCS web page (https://www.osha.gov/dsg/hazcom/) to view all of the changes to the 2012 HCS made in this final
rule.
OSHA received comments broadly supporting its proposed revisions to
Appendix A. (NAIMA stated that it ``supports the extensive changes to
Appendix A because the classification is clarified in a positive manner
and not changed . . . NAIMA agrees [with OSHA] that proposed amendments
will bring greater clarity'' (Document ID
0338, p. 7). ILMA stated, ``ILMA and its members are generally
supportive of OSHA's proposed changes to Appendix A. While largely
editorial, these changes better synchronize the Hazard Communication
Standard with the GHS and, with respect to ease of international trade,
such synchronization to those other jurisdictions, which are adopting
more recent versions of the GHS, assist ILMA members who do business
internationally'' (Document ID 0404, Att. 2, p. 1). ILMA further
requested that OSHA publish guides to assist the regulated community
with classification, particularly smaller companies who may not use
subscriptions to database-driven hazard communication software and who
may not understand how to incorporate non-animal testing results in
their classifications of mixture products (Document ID 0404, Att. 2, p.
2). OSHA anticipates updating some of the existing hazard communication
standard guidance products, such as the Hazard Classification guidance
(Document ID 0008), and also anticipates developing new products to
assist the regulated community in complying with the updated standard.
OSHA's proposed revisions to Appendix A are reviewed in detail
below, together with a review of the comments and testimony received on
each proposed revision and discussion of the provisions adopted in the
final rule.
I. General Classification Considerations (Appendix A.0)
In paragraph A.0.1, OSHA proposed to add a note from paragraph
1.3.3.1.3 of Rev. 7 (Document ID 0060, p. 21), providing that ``Where
impurities, additives or individual constituents of a substance or
mixture have been identified and are themselves classified, they should
be taken into account during classification if they exceed the cut-off
value/concentration limit for a given hazard class.'' OSHA did not
include this note in the HCS in 2012 because the definition of
substance in paragraph (c) references additives and impurities, and
therefore the classification of substances necessarily takes impurities
and additives into account. Nonetheless, the agency came to believe
that this note adds clarity and is useful for aligning with the GHS, so
proposed to add this note as paragraph A.0.1.3. OSHA's intent in
proposing this provision was to clarify that manufacturers and
importers must consider the hazards of all classified components when
classifying chemicals, which the agency believed would help ensure
accurate classification of chemicals and therefore improve protections
for workers.
OSHA received one comment regarding its proposed addition (Document
ID 0316, pp. 11-12). API supported the proposed revision, noting that
the proposed language aligns with the UN GHS and prior OSHA guidance
(Document ID 0316, pp. 11-12). OSHA did not receive any comments
objecting to the proposed addition of the note from Paragraph 1.3.3.1.3
of Rev. 7; therefore, the agency has finalized the addition of this
provision in new paragraph A.0.1.3.
Cal/OSHA, Cal/HESIS, Worksafe and National COSH submitted
suggestions that OSHA should modify paragraph A.0.3.5 to require a
single positive study to determine the hazard classification (Document
ID 0322, Att. 1, p. 9; 0313, p. 5; 0354, p. 1; 0407, p. 12). Cal/OSHA
stated that ``[r]equiring disclosure of the findings of a single
positive study that reports `statistically and biologically significant
positive results' is important for a number of reasons.'' They noted
that this single positive study rule would (1) represent the highest
possible standard of evidence in establishing causation in health
studies, (2) address the issue that scientific standards of evidence
can bias health effects studies toward false negative results, (3)
remove the economic incentive for a manufacturer, importer or
classifier not to classify based on a single study, and (4) reduce
``information asymmetries'' between producers and downstream buyers
(Document ID 0322, Att. 1, pp. 9-12).
OSHA did not propose any changes to A.0.3.5, therefore, these
comments are out of scope for this rulemaking. Additionally, OSHA
discussed its decision to remove the across-the-board ``one-study''
approach in the 2012 update to the HCS. The agency explained that the
hazard evaluation process in the HCS goes beyond simply identifying one
study and was preferable because it includes a complete evaluation of
all of the information available when determining what information to
transmit to users of the chemical, although the one-study approach was
still included in some criteria in the 2012 HCS (77 FR 17708).
OSHA also proposed to modify the introduction of paragraph A.0.4.1,
which previously characterized the process of mixture classification
provided in A.0.4.1(a) through (c) as ``recommended,'' to instead
characterize the specified process as mandatory. OSHA did not receive
any comments objecting to the proposed revision. Therefore, the agency
has finalized the introduction of paragraph A.0.4.1 to state that,
except as provided in A.0.4.2, the process of mixture classification is
based on the specified sequence of steps in A.0.4.1(a) through (c).
John Baker submitted a comment expressing support for the existing
language of paragraph A.0.4.3.2, which specifies that, if the
classifier has information that the hazard of an ingredient will be
evident (i.e., it presents a health risk) below the specified cut-off
value/concentration limit, the mixture containing that ingredient must
be classified accordingly, in light of the unique hazards posed by
nanoscale particles. Baker noted that ``[t]his is important because the
health (and to some extent, physical) hazard posed by nanoscale
particles is related to the large number of particles rather than their
aggregate weight percentage in the mixture'' (Document ID 0302). OSHA
did not propose to alter paragraph A.0.4.3.2, therefore, it is
unchanged in the final rule.
II. Acute Toxicity (Appendix A.1)
In paragraph A.1.1, OSHA proposed to revise the definition of acute
toxicity to refer to serious adverse health effects (i.e., lethality)
occurring after a single or short-term oral, dermal, or inhalation
exposure to a substance or mixture. The previous definition referred to
adverse effects occurring following oral or dermal administration of a
single dose of a substance, or multiple doses given within 24 hours, or
an inhalation exposure of four hours. This change was proposed to align
with Rev. 7 (Document ID 0060, p. 115; 0131).
Cal/OSHA commented that the acute toxicity definition needed more
clarity. Specifically, they noted that a ``serious health effect'' is
not synonymous with death (i.e., lethality) and that OSHA contradicted
itself in A.1.2.1 if it intended ``serious health effect'' to mean
death (Document ID 0322, Att. 2, p. 1). Cal/OSHA also commented that
``acute toxicity has to do with the timing of health effects, not their
nature; therefore, it is not appropriate to use the term `serious' to
qualify `health effects' '', and that ``there are many forms of acute
toxicity that do not lead to death,'' ranging from mild (e.g., skin
irritation) to serious (e.g., eye damage) to deadly (e.g., pulmonary
edema) (Document ID 0322, Att. 2, pp. 1-2). Finally, they noted that
non-lethal health effects are covered by their respective sections in
Appendix A and that the introductory material for acute toxicity should
make this clear.
OSHA agrees with Cal/OSHA that the general term ``acute'' refers to
timing,
rather than severity, of effects. In the proposed language, the term
``acute'' refers to health effects ``occurring after a single or short-
term oral, dermal, or inhalation exposure to a substance or mixture.''
However, as Cal/OSHA observed, non-lethal health effects are covered by
their respective sections in Appendix A, and thus the inclusion of
``serious adverse health effects (i.e., lethality)'' is a necessary
component of the definition to indicate to regulated parties that
within the HCS framework the classification of acute toxicity is only
used when the effects are sufficiently severe in order to avoid
duplicative classifications or unnecessary confusion between hazard
classifications.
Furthermore, the phrase ``serious adverse health effects (i.e.,
lethality)'' in the proposed definition is not intended to imply that
OSHA considers serious adverse health effects to be, in general,
synonymous with death. Rather, this phrase is taken from the GHS and is
intended to signify that the endpoint of the toxicological test methods
used to classify for ``acute toxicity'' is the death of animals in the
test population. The definition's reference to lethality is intended to
distinguish between hazards that meet the classification criteria
established for ``acute toxicity,'' utilizing toxicological test
methods with an endpoint of lethality, from hazards which are acute in
nature, but which should be classified under other sections in Appendix
A because the available information does not indicate lethality. The
phrase does not represent a determination by OSHA that other health
effects are not serious in the sense of being ``material'' for the
purposes of the OSH Act.
Finally, OSHA disagrees with Cal/OSHA that the new text added to
A.1.2.1 contradicts the agency's use of ``lethality'' in the proposed
definition of ``acute toxicity.'' Although some in vivo methods include
indicators such as ``significant clinical signs of toxicity'' to
approximate LD50/LC50 values, these methods are
using the clinical signs of toxicity to indirectly determine the acute
toxicity estimate (ATE) which is nevertheless intended to characterize
the lethality of a toxic substance. Therefore, OSHA maintains that its
revisions to A.1.2.1 do not contradict its use of the term
``lethality'' to characterize the endpoint used to classify a hazard
under ``acute toxicity.'' OSHA therefore declines to adopt the
recommendations made by Cal/OSHA regarding the definition of acute
toxicity.
John Baker commented that the modified definition is ``vague as to
the dimension of time'' and recommended that OSHA amend the proposed
definition of acute toxicity to refer to serious health effects (i.e.,
lethality) occurring following oral or dermal administration of a
single dose of a substance, or multiple doses ``given within 24 hours
or an inhalation exposure of 4 hours'' (Document ID 0302). However,
OSHA notes that the references to time in the acute toxicity definition
were purposely removed so that the definition would be more general and
neutral with respect to test guidelines (86 FR 9705). Since the HCS is
test method neutral, OSHA believes that the definitions in the HCS
should not include timeframes as listed in specific test guidelines.
Therefore, OSHA has retained the proposed modifications in the acute
toxicity definition to exclude timeframes in the final rule.
For the reasons discussed above, OSHA is finalizing the definition
of acute toxicity in paragraph A.1.1 as proposed.
OSHA also proposed to revise the classification criteria for
substances in A.1.2.1 to indicate that ``[w]hile some in vivo methods
determine LD50/LC50 values directly, other newer
in vivo methods (e.g., using fewer animals) consider other indicators
of acute toxicity, such as significant clinical signs of toxicity,
which are used by reference to assign the hazard category.'' This
change was proposed to align with classification criteria in the Rev. 7
(Document ID 0060, p. 115; 0131).
The Physicians Committee for Responsible Medicine (PCRM) supported
this revision and recommended that OSHA include the Collaborative Acute
Toxicity Modeling Suite (CATMoS) for screening chemicals for acute oral
toxicity, which can be used to predict GHS classification (Document ID
0295, p. 2). As the HCS is test method neutral and, as stated in
A.0.2.2, test guidelines that have been scientifically validated are
acceptable, OSHA has not included a specific reference to CATMoS in
paragraph A.1.2.1 in the final rule. However, the agency will consider
including information about CATMoS in one of its guidance products, as
it may be helpful to classifiers. API also supported the proposed
revision, noting its alignment with the GHS (Document ID 0316, p. 15).
Therefore, OSHA has finalized the classification criteria for
substances in A.1.2.1 as proposed.
OSHA also proposed slight revisions to Table A.1.1 to align with
Rev. 7 (Document ID 0060, p. 115; 0131). The GHS presents the ATE range
in Table A.1.1 using the term ``ATE'' to express the range, while the
2012 HCS uses the term ``and.'' OSHA proposed to change the ``and'' in
the ATE ranges to ``ATE'' to align with Rev. 7. The proposed
modification was not to change the classification criteria itself, but
as OSHA explained in the NPRM, would be more technically accurate and
consistent with the way the table is expressed in the European
Chemicals Agency's Guidance on the Application of the CLP Criteria:
Guidance to Regulation (EC) No 1272/2008 on classification, labelling,
and packaging of substances and mixtures (Document ID 0256, pp. 237-
238).
Michele Sullivan suggested that the format used in the 2012 HCS
Table A.1.1 should be retained, as it is familiar to small businesses,
businesses, and stakeholders operating in the U.S. According to
Sullivan, the ``focus of the USA OSHA HCS should be to express
technically correct values in a format easy to understand for USA
stakeholders, not to be consistent with formatting in EU regulations''
(Document ID 0366, p. 7).
Tom Murphy commented that ``the information to be conveyed in
[Table A.1.1] is in the format `>5 ATE <=50.' The placement of the
acronym in the format of the proposed rule makes the information
difficult to comprehend at a glance, and this opportunity for a
systemic failure is easily addressed: please consider changing the
format of the table entries to either `5 < ATE <= 50' or `ATE > 5 and
ATE <= 50' '' (Document ID 0277, p. 1).
OSHA believes that the proposed format, in addition to aligning
with Rev. 7 and the EU's CLP regulation, is also more technically
correct than the format used in the 2012 Table A.1.1. The ATE values
define the hazard categories for acute toxicity. For example, if a gas
has an ATE of less than or equal to 100, then it should be classified
as Category 1. The format used in the 2012 version of the standard
included just the number ``<= 100'' under the Category 1 column, while
the proposed Table A.1.1 includes ``ATE <= 100''. OSHA believes that
the proposed format displays the criteria in a more technically
accurate way, and that classifiers will understand the information
presented in this format. As such, OSHA has retained the modifications
to Table A.1.1 in the final rule. While Tom Murphy's suggested change
is technically equivalent to OSHA's proposal, it is not evident that
Murphy's notation would be significantly easier to understand ``at a
glance'' nor would it be consistent with the GHS or other international
partners. Therefore, OSHA is not adopting the suggestion.
OSHA is also making a correction to the heading of Table A.1.1 in
the final rule. The heading of Table 3.1.1 in Rev. 7 states, ``Acute
toxicity estimate (ATE) values and criteria for acute toxicity hazard
categories.'' OSHA inadvertently left out the change to the heading in
the NPRM and is making the editorial correction in this final rule to
maintain alignment with the GHS.
OSHA proposed to include a new sentence at the end of paragraph
A.1.2.3 to clarify that data from both animal tests and human studies
should be considered in evaluating acute toxicity. The proposed text
stated that ``[i]n cases where data from human experience (i.e.,
occupational data, data from accident databases, epidemiology studies,
clinical reports) is also available, it should be considered in a
weight of evidence approach consistent with the principles described in
A.0.3.'' To ensure human data is considered in classifying chemicals
for all acute toxicity hazard categories, the GHS added this clarifying
text in paragraph 3.1.2.3 (Document ID 0131, p. 116) and OSHA proposed
adding this sentence to align with Rev. 7. OSHA did not receive any
comments pertaining to the proposed revision. Therefore, the agency is
finalizing paragraph A.1.2.3 as proposed.
OSHA proposed a new paragraph A.1.2.4 which corresponds to Chapter
3.1 (paragraph 3.1.2.6.5) in Rev. 7 (Document ID 0060, p. 117). The
agency proposed this paragraph and its subparagraphs to require the
classifier to consider whether the chemical is corrosive to the
respiratory tract if data are available that indicate that the
mechanism of toxicity was corrosivity of the substance or mixture. The
proposed paragraph was also to clarify that the hazard corrosive to the
respiratory tract is covered under the HCS.
As OSHA explained in the NPRM, the agency did not explicitly
include the corrosive to the respiratory tract hazard in the HCS in
2012 but explained in its guidance, OSHA 3844: Hazard Communication:
Hazard Classification Guidance for Manufacturers, Importers, and
Employers, that this hazard should be considered during classification
(Document ID 0008, p. 48). The Hazard Classification guidance explains
that if the classifier has data indicating that there is acute
inhalation toxicity with corrosion of the respiratory tract that leads
to lethality, then the substance or mixture may be labeled with the
additional hazard statement ``corrosive to the respiratory tract.''
However, if the classifier has data that indicate acute inhalation
toxicity with corrosion of the respiratory tract and the effect does
not lead to lethality, then the guidance explains that the hazard may
be addressed in the Specific Target Organ Toxicity (STOT) hazard
classes included in Appendices A.8 and A.9 of the HCS. OSHA proposed to
include these clarifications in paragraphs A.1.2.4.1 and A.1.2.4.2, and
to change the ``may'' language from the guidance to ``must'' language
to ensure that corrosive to the respiratory tract is appropriately
considered during the classification process.
OSHA received several comments on proposed paragraph A.1.2.4. NIOSH
supported OSHA's proposed addition of paragraph A.1.2.4, noting that it
``adds information to help protect workers' safety and health,'' is in
line with the intent of the original 1983 HCS, and facilitates the
design and implementation of protective measures appropriate to the
hazard (Document ID 0281, Att. 2, p. 5). ILMA also supported the
addition of proposed paragraph A.1.2.4, noting that it would assure
appropriate consideration of hazards corrosive to the respiratory tract
during the classification process (Document ID 0356, Att. 1, p. 5). ICT
agreed that the addition of A.1.2.4 ``clarifies that some lethal
inhalation effects are not due to systemic poisoning but are due to
local destruction of respiratory tissue'' (Document ID 0324, p. 5).
ICT also requested clarification on when the statement would be
applicable. Both ICT and an anonymous commenter asked whether OSHA
intended the ``Corrosive to the respiratory tract'' hazard statement
for use instead of, or in addition to, the existing hazard statements
(e.g., ``Fatal if inhaled'') related to acute toxicity by the
inhalation route (Document ID 0265; 0324, p. 5).
ACC asked OSHA to clarify the proposed text in paragraphs A.1.2.4.1
and A.1.2.4.2. ACC indicated that ``in many cases, suppliers may choose
to warn for corrosion to the respiratory tract simply based on a
substance being corrosive to eyes and skin,'' and that ``without
knowledge as to whether this effect leads to lethality, it is not clear
how suppliers should classify.'' ACC further stated that it is unclear
what OSHA's intent is in referring to the regulatory text for STOT
classifications and questioned what the agency meant by the term
``addressed'' in A.1.2.4.2 (Document ID 0347, p. 16). In answer to
these requests for clarification, OSHA has modified the proposed
language. The following discussion explains the general classification
process and how label preparers are to apply a hazard statement for
corrosion of the respiratory tract based on the final text. To further
clarify how corrosive effect to the respiratory tract should be
addressed, OSHA is adding a note to each of the relevant tables in
Appendix C.
When classifying for corrosive to the respiratory tract the
classifier should take a tiered approach. If the classifier has data to
indicate the chemical is corrosive to the respiratory tract and the
effect leads to lethality, then the label should contain the hazard
statement ``Corrosive to the respiratory tract'' and the corrosion
pictogram in addition to the prescribed acute toxicity hazard
statement(s) and other label and SDS elements. If the classifier has
data that indicate the chemical is corrosive to the respiratory tract
but does not lead to lethality, then the chemical should be classified
using the criteria as provided under STOT single exposure (STOT-SE).
The label should then include the hazard statement ``Corrosive to the
respiratory tract if inhaled.'' This hazard statement should be used
instead of a more general STOT-SE hazard statement for the respiratory
tract (e.g., ``Causes damage to respiratory tract if inhaled'') and
unlike the corresponding statement for acute toxicity, this hazard
statement includes ``if inhaled'' because A.8.2.1.2 requires the
relevant route(s) of exposure by which the classified substance
produces damage to be identified. Additionally, OSHA is requiring the
use of the more specific corrosion pictogram instead of the more
general health pictogram when this hazard is addressed under STOT.
However, if there are other target organ hazards, the current STOT
hazard statement and pictogram should be used to communicate those
hazards, in addition to the required hazard statement and pictogram for
corrosive to the respiratory tract.
Finally, in response to ACC's comment on classifiers' current
practices, OSHA is modifying the proposed language to state that if the
classifier does not have direct data on corrosivity to the respiratory
tract (and would therefore not classify the chemical under STOT-SE) but
the chemical is classified under either skin corrosion/irritation or
serious eye damage/eye irritation, the classifier must consider the
available data (including skin and/or eye data) to determine whether
the chemical may be corrosive to the respiratory tract if inhaled. If
they determine that it may be corrosive to the respiratory tract, they
must include the hazard statement corrosive to the respiratory tract
along with the already required hazard statement (e.g., causes severe
skin burns and eye damage) and pictogram (e.g.,
corrosion) to ensure that the respiratory corrosion hazard is
communicated to downstream users. This is intended to ensure workers
have complete hazard information when handling a substance or mixture
that may cause corrosion to the respiratory tract in order to avoid
gases, vapors, or mists that may be generated under certain conditions
(e.g., accidental spill) even if the substance or mixture is not
intended for such an exposure route.
As OSHA indicated in proposed paragraph A.1.2.4, the corrosive to
the respiratory tract classification is intended to be used, when
appropriate, in addition to the inhalation toxicity classification and
the hazard statement ``corrosive to the respiratory tract'' would be
used in addition to the hazard statements for acute toxicity. To
clarify this provision, OSHA has modified proposed paragraph A.1.2.4.1
to state, ``If the classifier determines the chemical is corrosive to
the respiratory tract and data are available that indicate that the
effect leads to lethality, then in addition to the appropriate acute
toxicity pictogram and hazard statement, the chemical must be labeled
with the hazard statement `corrosive to the respiratory tract' and the
corrosion pictogram.'' OSHA anticipates providing additional guidance
on the ``Corrosive to the respiratory tract'' hazard statement
following publication of the final rule.
Cal/OSHA commented that paragraph A.1.2.4.1, as written in the
NPRM, would not adequately warn workers and emergency responders,
reasoning that when inhalation of a corrosive chemical substance
``leads to lethality,'' that information should be communicated on the
label, not just on the SDS (in some cases ``Fatal if inhaled'' would
appear on the SDS) (Document ID 0451, Att. 1, p. 2). Cal/OSHA suggested
alternative language for A.1.2.4.1 to require that, if the classifier
determines a chemical is corrosive to the respiratory tract and data
are available that indicate that the effect leads to lethality, then
the chemical must be labeled with either the hazard statement, ``This
chemical is corrosive to the respiratory tract and can cause death if
inhaled'' or ``This chemical is corrosive to the respiratory tract and
can be fatal if inhaled'' (Document ID 0451, Att. 1, p. 2).
Because the hazard statement ``Corrosive to the respiratory tract''
would supplement, rather than replace, the appropriate acute toxicity
pictogram and hazard statement, OSHA disagrees with Cal/OSHA that the
proposed supplemental hazard statement ``Corrosive to the respiratory
tract'' should be modified from the GHS statement when the data
indicate lethality. The acute toxicity statements already indicate
lethality when appropriate. For example, a chemical that is acute
inhalation toxicity Category 1 and is corrosive to the respiratory
tract will carry the skull and crossbones pictogram and the hazard
statement ``Fatal if inhaled'' in addition to the ``Corrosive to the
respiratory tract'' statement.
An anonymous commenter asked whether hazard categories are being
established for ``Corrosive to the respiratory tract'' and, if so, how
the categories will be defined, how mixtures should be classified that
contain component(s) deemed ``Corrosive to the respiratory tract,'' and
if cut-off values would be established. They also noted that this
hazard statement does not appear in Appendix C of the proposed standard
and asked what signal word, pictogram, and precautionary statements
should appear on the SDS and label when the ``Corrosive to the
respiratory tract'' hazard statement is used (Document ID 0265).
As explained above, the ``corrosive to the respiratory tract''
hazard is not a distinct hazard class. Therefore, no hazard categories
will be established for it. Classification of mixtures would follow the
same principles as for other health hazards. If there are no data for
the mixture as a whole, mixtures that contain component(s) deemed
corrosive to the respiratory tract should be classified as acutely
toxic, STOT-SE, skin corrosion/irritation, or eye damage/irritation and
carry the appropriate pictogram(s), signal word, hazard statement(s)
and precautionary statement(s) on the label and SDS based on the hazard
class and category. The SDS and label for the mixture will also contain
the hazard statement ``Corrosive to the respiratory tract'' (for acute
toxicity, skin corrosion/irritation, or eye damage/irritation) or
``Corrosive to the respiratory tract, if inhaled'' (for STOT-SE). As
discussed above and in the Summary and Explanation for Appendix C, OSHA
agrees that the hazard statements for corrosion to the respiratory
tract should be included in Appendix C along with the other label
element information and has included it there in the final rule. The
Summary and Explanation for Appendix C includes further discussion of
the label element requirements associated with corrosion to the
respiratory tract.
ACC expressed concern about the impact of this proposal on GHS
harmonization, stating that ``[t]he introduction of a new Acute
Toxicity and Specific target organ toxicity (single exposure) (STOT SE)
classification for corrosion to the respiratory tract will cause a
number of significant classification differences between jurisdictions
and confusion among manufacturers and importers'' and argued that the
information could be accurately represented in Section 11 of the SDS.
They noted the EU as an example which ``includes supplementary EUH
[European Union hazard] phrases, but does not require the use of an
entirely separate classification'' (Document ID 0347, p. 16).
Furthermore, ACC stated that STOT classifications are not
appropriate for classifying respiratory corrosion. According to ACC,
STOT repeat exposure (STOT-RE) is not appropriate because respiratory
corrosion is an acute effect; STOT-SE Category 1 or Category 2 are also
not appropriate because respiratory corrosion is not a systemic effect;
and STOT-SE Category 3 is not appropriate because it only refers to
respiratory irritation (Document ID 0347, p. 17). VelocityEHS similarly
opined that corrosion to the respiratory tract does not fit the
criteria under STOT because ``damage from corrosivity/causticity is not
usually tied to a specific organ, but damages multiple tissues (skin,
eyes, mucus membranes). Corrosive/caustic substances damage whatever
tissue they come into contact with, and therefore do not meet the
definition of being target organ specific'' (Document ID 0320, p. 2).
OSHA disagrees with ACC and VelocityEHS' position that STOT
criteria should not be used for corrosion to the respiratory tract.
Specifically, OSHA disagrees with ACC's position that STOT-SE Category
1 and Category 2 cover only systemic effects and are therefore not the
appropriate hazard classes and categories to address the corrosion of
the respiratory tract hazard. The GHS recognized that local effects are
also covered under STOT in Rev. 2, published in 2007. Prior to Rev. 2,
the hazard class chapter was entitled ``Specific Target Organ/Systemic
Toxicity.'' In Rev. 2, the UNSCECHS agreed to replace the term
``Specific target organ/systemic toxicity'' and all its related terms
with ``Specific target organ toxicity'' on the understanding that,
according to paragraphs 3.8.1.1 and 3.9.1.1 of the GHS, ``all
significant health effects that impair function (both reversible and
irreversible, immediate and/or delayed) are regarded to be ``target
organ toxicity'', irrespective of the toxic effects being local or
not'' (ST/SG/AC.10/C.4/22, available at https://unece.org/DAM/trans/doc/2006/ac10c4/ST-SG-AC10-C4-22e.pdf, p. 6).
Corrosion to the respiratory tract fits the meaning of ``Specific
target organ toxicity'' as explained by the UNSCECHS.
Similarly, OSHA disagrees with VelocityEHS's reasoning that the
occurrence of corrosion in multiple organs (e.g., skin, eye, mucus
membranes) excludes classification for a respiratory tract STOT. Under
STOT-SE in the HCS (A.8.1.4), classifiers should take into
consideration both changes in a single organ or biological system and
generalized changes of a less severe nature involving several organs.
However, OSHA agrees with ACC that since respiratory tract
corrosion is an acute effect, STOT RE is not an appropriate hazard
class for corrosion of the respiratory tract. OSHA is therefore
removing the reference to A.9 from A.1.2.4.2. OSHA also agrees that
corrosion of the respiratory tract would not be appropriately
classified as STOT-SE Category 3 because it would not meet the criteria
in A.8.2.2. The language in A.1.2.4.2 is a general reference that
corrosive to the respiratory tract should be classified under STOT and
therefore no regulatory text change is necessary to exclude STOT
Category 3. Additionally, to make this clear, OSHA has not included a
note regarding corrosive to the respiratory tract in Appendix C under
the table for STOT-SE Category 3. For the reasons explained above, OSHA
maintains that STOT-SE Category 1 and Category 2 should be used for
classifying corrosive to the respiratory tract hazards when the data
meet the criteria and indicate the effect does not lead to lethality.
OSHA disagrees with ACC's comment that the use of STOT criteria
would cause significant classification differences between
jurisdictions, including diverging from the EU's approach to
classification. OSHA notes that ACC may have misunderstood OSHA's
intent regarding corrosive to the respiratory tract since paragraph
A.1.2.4 incorporates additional hazard phrases but does not create an
entirely separate classification, which is also, as ACC noted, how the
EU treats corrosion of the respiratory tract. However, OSHA has made
changes to the approach so that the label and SDS would be more
consistent with other jurisdictions, including the EU. First, OSHA has
updated the label elements under STOT-SE for consistency so the hazard
statement and pictogram on the label (and SDS) would be equivalent to
the EU. Additionally, OSHA has updated its approach to include the
hazard statement ``Corrosive to the respiratory tract'' under
Appendices A.2 and A.3 when there are insufficient data to support
classification under STOT. This is similar to the EU approach where if
a chemical is corrosive and the chemical may be inhaled then the EUH071
``Corrosive to the Respiratory Tract'' hazard phrase must be used.
Furthermore, OSHA disagrees with ACC that information on corrosivity to
the respiratory tract can be sufficiently covered in Section 11 of the
SDS, as Section 11 is not typically used to convey important toxicity
information to workers at a level of generality appropriate to a lay
reader, but rather to safety and health experts at a more detailed
level.
VelocityEHS further commented that labeling elements present for
corrosive to the respiratory tract versus acute toxicity and STOT could
be confusing or misleading to a worker since the pictogram for
corrosion is different. To illustrate this issue, VelocityEHS provided
an example indicating that if a chemical is corrosive to the
respiratory tract, but the effect does not lead to lethality, corrosion
still occurs and is likely corrosive to the skin and eye. In that case,
they noted that providing the health hazard pictogram to represent the
STOT along with the corrosion pictogram could be misleading and
confusing as to why the health hazard pictogram was included (Document
ID 0320, p. 3)
VelocityEHS suggested alternate criteria for evaluating corrosive
to the respiratory tract when it does not lead to lethality, including
modified text for paragraph A.1.2.4 and its subparagraphs that lays out
a tiered approach for classifying chemicals as corrosive to the
respiratory tract. They suggested first classifying chemicals as
corrosive to the respiratory tract under the skin or eye hazard
classes, and then if not classified under either of these hazard
classes, classifying under STOT-SE. VelocityEHS provided additional
text for Appendices A.2 (Skin Corrosion/Irritation) and A.3 (Serious
Eye Damage/Eye Irritation) including classification guidance and label
elements for corrosive to the respiratory tract (Document ID 0320, pp.
2-7).
OSHA agrees with VelocityEHS that Appendices A.2 and A.3 are
relevant for corrosive to the respiratory tract and has updated the
text of A.1.2.4.2 accordingly, but disagrees with VelocityEHS's
suggestion that they should be the primary hazard classes that should
address corrosive to the respiratory tract. As discussed above, OSHA
believes that STOT-SE criteria are appropriate when the data indicate
corrosion to the respiratory tract and indicate non-lethality;
therefore, Appendix A.8 (STOT-SE) is appropriate. However, the agency
recognizes that in many cases the data may be insufficient to justify a
STOT-SE classification and therefore it would be appropriate to include
corrosive to the respiratory tract based on data used for either skin
corrosion/irritation classification or serious eye damage/eye
irritation classification.
OSHA also disagrees with VelocityEHS that workers will find the
label elements for acute toxicity confusing or misleading when used
alongside label elements for corrosion of the respiratory tract. OSHA
understands that workers may be already familiar with the corrosion
pictogram because of skin and eye corrosion, and with effective
training, the combination of the corrosion pictogram and the skull and
bones pictogram for acute toxicity will helpfully and accurately convey
the level of severity of the hazard and thus are helpful to include
together. However, OSHA does believe that more targeted hazard
communication is warranted for STOT SE and, as explained above, is
adding a new hazard statement ``Corrosive to the respiratory tract, if
inhaled'' and requiring the use of the corrosivity pictogram instead of
the health pictogram. Workers will also need to be trained on the
corrosive to respiratory tract hazard and that they may see the
corrosion pictogram in addition to the skull and crossbones, but OSHA
believes that with the training required under the HCS these
modifications will ultimately provide better information and will not
be confusing.
However, OSHA also notes that in Appendix C, the agency gives
direction on the label elements and in particular has added a new
paragraph in this rulemaking (C.3.2.4) to make clear that if multiple
hazards require the same pictogram only one pictogram should appear on
the label (see discussion in Appendix C). Additionally, Appendix C
provides flexibilities under C.2 (Hazard statements) and C.4
(Precautionary statements) indicating that the label preparer can omit
statements if they can show that a statement is inappropriate or that
modified statements improve readability. Lastly, the label preparer can
provide supplemental information to the label (or SDS) as long as the
information does not contradict or cast doubt on the required
information. With all of these flexibilities, OSHA believes SDS and
label preparers will be able to minimize any confusion that VelocityEHS
suggests will exist.
Following the discussion above, OSHA is finalizing the new
paragraph A.1.2.4 which provides that if the
classifier has data indicating that there is acute inhalation toxicity,
based on lethality data, with corrosion of the respiratory tract, then
the substance or mixture should be labeled with the additional hazard
statement ``Corrosive to the respiratory tract'' and the corrosion
pictogram. OSHA is retaining the provision that if the classifier has
data that indicates corrosion of the respiratory tract and the effect
does not lead to lethality, then the hazard must be addressed in the
STOT-SE (A.8) hazard class, with the modified hazard statement and
corrosion pictogram in lieu of the usual STOT-SE requirements. If there
are insufficient data to classify the hazard as STOT, and the
classifier determines based on relevant skin and/or eye data that the
chemical may cause corrosion of the respiratory tract, then the hazard
statement ``Corrosive to the respiratory tract'' must be used in A.2
and/or A.3, as appropriate. As described further in the summary and
explanation for Appendix C, OSHA has also added notes to the relevant
sections in Appendix C to further clarify this issue. However, OSHA is
removing the reference to STOT-RE (A.9) from paragraph A.1.2.4.2.
Additionally, OSHA intends to update its Hazard Classification guidance
document (Document ID 0008) following the publication of the final rule
and anticipates adding further guidance for ``Corrosive to the
respiratory tract.''
Paragraph A.1.3.6.1 explains how to classify a mixture when there
are data for all of the ingredients in the mixture. Cal/OSHA commented
on paragraph A.1.3.6.1 that the units that are used in the ATE formula
are unclear and suggested that OSHA provide more explanation and an
example using each of the applicable units (Document ID 0322, Att. 2,
p. 3). OSHA did not propose a change to the ATE formula in A.1.3.6.1
and therefore this comment is outside the scope of this rulemaking.
However, Table A.1.1, Acute toxicity estimate (ATE) values and criteria
for acute toxicity hazard categories, provides the units that should be
used to calculate the ATE by route of exposure. Additionally, OSHA
provides guidance on classification of acute toxicity and examples
using the ATE formula in its Hazard Classification guidance document
(Document ID 0008, pp. 33-35).
In Figure A.1.1 and paragraph A.1.3.6.2.2, OSHA proposed to correct
the cross-reference from A.1.3.6.2.3 to A.1.3.6.2.4. OSHA did not
receive any comments pertaining to this proposed revision and is
therefore finalizing the corrections to Figure A.1.1 and paragraph
A.1.3.6.2.2 as proposed.
OSHA also proposed to amend paragraph A.1.3.6.2.3. If a mixture
contains an ingredient of unknown acute toxicity at a concentration of
at least one percent, paragraph A.1.3.6.2.3 previously required a
statement that ``X'' percent of a mixture consists of ingredient(s) of
unknown toxicity on the label and SDS. OSHA proposed to revise this
paragraph to require a statement that ``X'' percent of the mixture
consists of ingredient(s) of unknown acute (oral/dermal/inhalation)
toxicity on the label and SDS in such cases (emphasis added), thus
indicating that the percentage of unknown acute toxicity must be
differentiated by route of exposure. Given that it is possible to have
unknown ingredients for more than one relevant route of exposure (e.g.,
oral, dermal, inhalation), OSHA reasoned that differentiating the
statement by route would be helpful to chemical users. This proposed
change aligns with paragraph 3.1.3.6.2.2 in Rev. 7 (Document ID 0060,
p. 121). OSHA also proposed to delete the second paragraph in
A.1.3.6.2.3 because it is duplicative of the first paragraph.
ILA supported the proposed revision in A.1.3.6.2.3, stating that
the change ``adds value to the label and provides valuable information
to the end user'' (Document ID 0315, p. 3). However, ILA also commented
that more clarity is needed surrounding when the statement should be
used, and that it may be difficult for users to understand when the
statement of unknown toxicity is required on a label. Specifically,
they asked ``[s]hould the statement be used when the material is
classified as Acute Oral/Dermal/Inhalation without testing AND contains
components greater than 1% with unknown toxicity? OR if the intention
is to place this statement on labels when no testing data is available,
the material does not have an acute oral/dermal/inhalation
classification but contains components greater than 1% with unknown
toxicity?'' (Document ID 0315, p. 3).
OSHA's proposed changes to A.1.3.6.2.3 do not affect when the
statement of unknown acute toxicity is required. As clarified in OSHA's
classification guidance (Document ID 0008, p. 42), the unknown acute
toxicity statement is required on the label and the SDS where the
chemical mixture is already classified as acutely toxic for a
particular route of exposure, and there are one or more other
``relevant ingredients'' of unknown acute toxicity for that particular
route. In the event that an ingredient with unknown acute toxicity is
used in a mixture at a concentration >= one percent, and the mixture as
whole has not been tested, the mixture cannot be attributed a
definitive acute toxicity estimate. In this situation, the mixture is
classified based on the known ingredients only. A statement that X
percent of the mixture consists of ingredient(s) of unknown acute
toxicity (oral, dermal/inhalation) is required on the label and SDS in
such cases. Conversely, if a mixture as a whole has been tested but is
not classified based on this testing, then no statement is required
regardless of ingredients (Document ID 0008, p. 42). OSHA anticipates
updating this guidance following the publication of the final rule and
including a discussion of this provision.
An anonymous commenter submitted a question pertaining to
paragraphs A.1.3.6.2.3, C.3.3, and Appendix D of the proposed HCS,
which require a statement of the concentration of ingredients of
unknown acute toxicity to appear in Section 2 of the SDS and on the
label: ``[c]onsider the case of a mixture in which the exact
concentration(s) of hazardous component(s) are withheld as trade
secrets and reported as prescribed concentration range(s) (pursuant to
paragraph (i)(1)(iv)) in Section 3 of the SDS. In Section 2 of the SDS
and on the label, is it acceptable to report the percentage of
ingredient(s) of unknown acute toxicity as a range corresponding to one
of the prescribed ranges, or must the exact percentage be reported?''
(Document ID 0266). OSHA has addressed this comment below in the
Summary and Explanation for Appendix D.
OSHA received an anonymous comment that referred to the ``split
entry concept'' and the agency's 2013 LOI (available at https://www.osha.gov/laws-regs/standardinterpretations/2013-04-02), which
describes ``split entry'' as a concept used in the EU that allows for a
modified GHS classification in certain situations, such as when
particle size in laboratory tests differs from the particle size
expected in workplace exposures (Document ID 0270). The commenter asked
OSHA to clarify in the HCS how SDS providers should classify
``substances that are acutely toxic by inhalation that are not
respirable in the form in which they are supplied'' (Document ID 0270).
OSHA did not propose to address this issue in the NPRM, therefore,
the request for clarification in the HCS is outside the scope of this
rulemaking. However, OSHA notes that the 2013 LOI states that the HCS
2012 classification process does not support the use of the split entry
concept. The agency will
consider addressing this issue in updated guidance to clarify that the
use of ``split entry'' is still not allowed under the standard.
After reviewing these comments, OSHA is finalizing the proposed
changes to paragraph A.1.3.6.2.3.
III. Skin Corrosion/Irritation and Serious Eye Damage/Eye Irritation
(Appendices A.2 and A.3)
OSHA proposed revisions to the sections on skin corrosion/
irritation and serious eye damage/irritation (Appendices A.2 and A.3),
which correspond to Chapters 3.2 and 3.3 in the GHS, respectively. As
OSHA explained in the NPRM (86 FR 9703), the UNSCEGHS, in its 16th
Session (December 2008), assembled an informal working group to review
the content of Chapters 3.2 and 3.3 in the GHS and to propose editorial
revisions in order to enhance clarity and user-friendliness in the
application of the criteria (Document ID 0093). The group's primary
focus was to change the order of the text to ensure that the
classification strategy was clear, and to change the testing scheme to
more of an evaluation scheme, since the GHS, like the HCS, is test
method neutral. The work of the informal working group was not complete
before OSHA published its updates to the HCS in 2012. However, the
working group completed its efforts to clarify the skin corrosion/
irritation and serious eye damage/eye irritation chapters prior to
publication of the NPRM. The work was approved by the UNSCEGHS in 2012
(Document ID 0212). Accordingly, in 2021, OSHA proposed to revise
Appendices A.2 and A.3 to incorporate all the modifications to the GHS
skin corrosion/irritation and serious eye damage/eye irritation
chapters agreed to by the UNSCEGHS up to and including Rev. 7. The
agency reasoned that this would ensure that OSHA's HCS remains aligned
with the GHS.
OSHA proposed substantial revisions to Appendix A.2 (Skin
Corrosion/Irritation) that reflect the final changes the UNSCEGHS
adopted through Rev. 7. However, Rev. 8, published in July 2019
(Document ID 0065, pp. 129-145), expanded the use of non-animal test
methods in Chapter 3.2 (skin corrosion/irritation). These changes
include recognition of specific in vitro test methods, reorganization
of the chapter, reorganization of the tiered approach with an updated
Figure 3.2.1 to reflect those changes, as well as descriptive text on
use of new test methods, structure activity relationship (SAR) and read
across methods, and an updated decision logic diagram. Table 3.2.1 from
Rev. 8 updated the tiered approach for classification, including an
elevation in acceptance of in vitro data to tier 2 of the approach. The
updated tiered approach also included consideration of conflicting
lower-tiered data when the lower tier suggests a higher classification
level. In addition to the changes in the table, Rev. 8 updated the
background information to provide additional guidance for how to use
non-animal test data to classify chemicals.
In Section XV., Issues and Options Considered, in the NPRM, OSHA
requested comments from the regulated community to determine if the
agency should adopt Chapter 3.2 from Rev. 8 with all of the revisions
to the classification scheme. The agency noted that adoption would
greatly benefit classification for new chemicals where no existing data
currently exists. It also explained that adopting these updates in the
HCS would not require a re-evaluation of chemicals already classified
because the overall tiered approach for evaluating existing data has
been retained.
OSHA received several comments that favored including updates from
Rev. 8 in the revised HCS. ILMA supported the inclusion of Rev. 8's
tiered approach in Appendix A.2 and indicated that their members would
benefit from the inclusion of data from non-animal testing protocols,
although they also noted that changes in criteria for skin and eye
irritation would present the biggest compliance challenge to ILMA
members and would require ILMA members to spend more time reviewing the
updated criteria to assure that all available data are considered
(Document ID 0356, pp. 5-6). PCRM also supported incorporating in
Appendix A.2 ``all revisions to the classification scheme for skin
corrosion/irritation'' from Rev. 8 (Document ID 0295, p. 1). ACC
thanked OSHA ``for taking into consideration the additional flexibility
that the inclusion of Chapter 3.2 (specifically Table 3.2.1) provides''
and expressed support for the use of non-animal test methods for
classification purposes (Document ID 0347, p. 6). PETA, HCPA, and NAIMA
also expressed support for OSHA expanding the use of non-animal testing
(Document ID 0282, p. 1; 0327, p. 8; 0338, p. 7).
NIOSH supported adoption of a tiered approach to classification of
chemicals for skin irritation and corrosion (Document ID 0281, Att. 2,
p. 5). NIOSH also recommended that OSHA consider the NIOSH Current
Intelligence Bulletin 61: A Strategy for Assigning New NIOSH Skin
Notations as a resource (NIOSH [2017]. A strategy for assigning new
NIOSH skin notations. Cincinnati, OH: U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health, DHHS (NIOSH) Publication
No. 2009-147). NIOSH stated that the proposed expansion of the use of
nonanimal test methods in evaluating skin corrosion/irritation from
Rev. 8 ``would elevate the use of in vitro methods in the tiered
approach to the classification of chemicals under Appendix A.2 Skin
Corrosion/Irritation . . . [and] would be beneficial if systemic
effects of the chemical in question have been ruled out. In vitro
methods predictive of in vivo outcomes continue to improve but may not
accurately predict systemic response [Stueckle and Roberts 2019]''
(Document ID 0281, Att. 2, p. 5).
A few commenters expressed concerns with adopting Rev. 8. Michele
Sullivan commented that it was good planning for OSHA to consider
adopting Rev. 8, but expressed concern that the regulatory text was not
provided (Document ID 0366, p. 2). API similarly requested that OSHA
provide the exact regulatory language (Document ID 0316, p. 31). In
response to these stakeholder concerns regarding the regulatory text,
OSHA notes that the NPRM provided the updated criteria from Rev. 8
which describes the classification criteria as well as the full text of
the GHS purple book for Rev. 8 (Document ID 0065, pp. 129-136). OSHA
believes that this provided ample notice for interested parties. No
commenter expressed specific concerns about the GHS classification
criteria provided in the docket.
OSHA agrees with commenters that including the updates in Rev. 8 to
the skin corrosion/irritation chapter would benefit classification and
has revised Appendix A.2 in the final rule to align with the updates in
Rev. 8. The agency is not including any revisions regarding Category 3
because the agency did not adopt Category 3 in 2012, which is primarily
for consumer products, and commenters agreed this decision was
appropriate (77 FR 17709). OSHA did not receive any comments suggesting
that the agency should adopt Category 3 in this final rule and is not
including it in this update. OSHA has also not included the guidance
material in Rev. 8.
OSHA will take NIOSH's concern regarding systemic effects into
account when updating its classification guidance. The agency also
acknowledges ILMA's concern regarding the additional time required to
review the updated criteria. However, OSHA reiterates that the agency
is not
changing the HCS classification criteria. The updates from Rev. 8
provide additional guidance for how to use non-animal test data to
classify new chemicals. Inclusion of these updates in the HCS does not
require a re-evaluation of chemicals already classified because the
overall tiered approach for evaluating existing data has been retained
(86 FR 9692). However, OSHA has taken ILMA's suggestion and extended
the compliance deadlines from the timelines in the NPRM (see Summary
and Explanation for paragraph (j)).
In the NPRM, OSHA's proposed text for Appendix A.2 was based on
Rev. 7, so the agency's decision, based on the comments it received, to
align with Rev. 8 necessarily entails changes from the proposed text.
Thus, many of the sections discussed below are now numbered differently
or may be rephrased. Additionally, several new sections have been
added. These changes are discussed below in the order in which they
appear in Appendix A.2.
In Appendix A.2, skin corrosion/irritation, Paragraph A.2.1.1
provides updated definitions of skin corrosion and skin irritation, and
those definitions are the same in Rev. 7 and Rev. 8. Cal/OSHA suggested
that OSHA should clarify the revised definitions in paragraph A.2.1.1
since the time references were removed from the definition (Document ID
0322, Att. 2, pp. 3-4). As discussed below, OSHA proposed to modify the
HCS health hazard definitions to make the definitions more general and
to remove the references to the test guidelines. OSHA believes these
revisions provide clearer and more concise definitions and a clear
differentiation between the ``definitions'' section and ``general
considerations'' section. Therefore, OSHA has retained the revised
definitions of skin corrosion and skin irritation in the final rule.
However, in response to Cal/OSHA's comments, OSHA has modified the
final definitions of skin corrosion and skin irritation to include the
word ``initial'' to clarify the time parameters. The updated
definitions in the final rule read, ``Skin corrosion refers to the
production of irreversible damage to the skin; namely, visible necrosis
through the epidermis and into the dermis occurring after initial
exposure to a substance or mixture'' and ``Skin irritation refers to
the production of reversible damage to the skin occurring after initial
exposure to a substance or mixture.'' Additionally, OSHA has included
information about the time parameters in A.2.2.2.1.1, A.2.2.2.2.1, and
A.2.2.2.2.2. For skin corrosion in A.2.2.2.1.1, the agency is adding
the word ``initial.'' For skin irritation in A.2.2.2.2.1, OSHA is
including the text ``following its application for up to 4 hours'' and
in A.2.2.2.2.2 is adding the text ``when after the first application''
to indicate that these provisions refer to a one-time exposure.
OSHA originally proposed that new paragraph A.2.1.2 would clarify
the sequence in which data should be evaluated when classifying for
skin corrosion/irritation using a tiered evaluation approach. However,
since OSHA is now aligning Appendix A.2 with Rev. 8, it is finalizing
language based on Rev. 8's language in 3.2.1.2, which clarifies that
all available and relevant information must be considered when
conducting classifications. It also indicates that all classifications
must be based on data generated using internationally validated and
accepted methods. OSHA believes that the content of its original
proposal for A.2.1.2 is adequately clarified in Figure A.2.1 and is not
necessary to include in A.2.1.2. Also to align with Rev. 8, OSHA is
adding paragraph A.2.1.3, which was not in the text of the proposed
rule, to provide information on the tiered approach to classification
of skin corrosion/irritation hazards.
OSHA proposed to revise paragraph A.2.2 to present the information
in a clearer, more logical fashion but did not propose to change the
classification criteria. The text OSHA originally included in the NPRM
for this paragraph was based on Rev. 7, but because the agency has
decided to align it with Rev. 8, the language and numbering has changed
since the proposal. Paragraph A.2.2 contains more information on when
to use sub-categories 1A, 1B, and 1C. New paragraphs A.2.2.1 and
A.2.2.2 provide information on classification based on standard human
data and animal test data, respectively. Paragraph A.2.2.2.1 and
subparagraphs A.2.2.2.1.1 and A.2.2.2.1.2, as well as Table A.2.1,
provide classification information and criteria for skin corrosion.
Skin irritation information and criteria are included in paragraph
A.2.2.2.2.
ACC commented that OSHA should retain flexibility in classification
and ``avoid an overly prescriptive inclusion of Table 3.2.1'' of Rev.
8. ACC did not explain what it might consider an ``overly prescriptive
inclusion of Table 3.2.1'' to be. Since ACC expressed general support
of updating Appendix A.2 to expand the use of non-animal test methods
as outlined in Rev. 8 and praised ``the additional flexibility that the
inclusion of Chapter 3.2 (specifically Table 3.2.1) provides'' in their
comments, and since OSHA has not added any requirements for testing or
requirements to re-evaluate chemicals already classified, the agency
believes its approach to incorporating Rev. 8 changes into Table A.2.1
(which is drawn from Table 3.2.1) would not likely be ``overly
prescriptive'' in ACC's view (Document ID 0347, p. 6).
Tom Murphy commented on paragraph A.2.2.2.1 (now A.2.2.2.2.1),
suggesting that OSHA consider a change from the proposed text ``A
substance is irritant to skin when it produces reversible damage to the
skin following its application for up to 4 hours'' to ``A substance is
an irritant to the skin when it produces reversible damage to the skin
within 4 hours of the initial application'' (Document ID 0277, p. 1).
Murphy reasoned that an improper reading of the proposed wording could
lead a reader to misunderstand that the application is constantly
applied (rather than applied once and allowed to remain) for up to four
hours while observing the subject for reversible damage.
The language in paragraph A.2.2.2.1 (now A.2.2.2.2.1), ``for up to
4 hours,'' is consistent with the language used in the GHS and was
taken from the Organisation for Economic Co-operation and Development
(OECD) test guidelines, which are widely recognized and accepted around
the world. Classifiers are already familiar with the language and the
associated test guideline. Therefore, OSHA is maintaining this
provision as proposed in the final rule. However, as discussed above,
OSHA has updated the definition of skin irritation in A.2.1.1 to
include the word initial and paragraph A.2.2.2.1 (now A.2.2.2.2.2) with
the additional phrase ``when after the first application'' for
classification for skin irritation (category 2), which should provide
the requested clarity.
OSHA also received comments on paragraph A.2.2.2.4 (now
A.2.2.2.2.4), which discusses the variability of animal irritant
responses within a test. Cal/OSHA commented that the text in the
paragraph is not clear (Document ID 0322, Att. 2, p. 4). They asked
what OSHA meant by the word ``might,'' and if the manufacturer or
importer is required to act on this information or not. They also
inquired about the meaning of a ``very elevated mean score,'' how
``other responses'' fulfill this criterion, and how this increases
``the sensitivity of the classification system.'' In response to Cal/
OSHA's comments, OSHA modified the text in the third sentence of
paragraph A.2.2.2.2.4 from ``might'' to ``should'' to
clarify that manufacturers should designate a substance as an irritant
when at least one of three test animals show a very elevated mean score
according to the test method used throughout the study, including
lesions persisting at the end of an observation period of normally 14
days. OSHA also modified the text in the fourth sentence, from
``could'' to ``should'' to indicate that other irritant responses
should also fulfill the same criterion. OSHA notes that the agency did
not propose to modify this paragraph, which is in the 2012 HCS as
A.2.2.2.2, but the agency believes adopting this change is consistent
with the changes made throughout Appendix A to provide clarity. With
regard to Cal/OSHA's questions about other language in A.2.2.2.4, OSHA
has provided detailed guidance on classification which discusses each
hazard class. In particular, OSHA has provided numerous examples for
skin corrosion and irritation classification scenarios which provide
detailed rationale on applying the classification principles (Document
ID 0008, pp. 69-85) and therefore does not believe that the intention
of the text is unclear to regulated parties, but will review the
guidance to determine if additional material should be added to clarify
the terms addressed by Cal/OSHA.
Table A.2.2 provides the classification criteria for skin
irritation Category 2. Cal/OSHA asked why the classification criteria
indicate that a chemical should be deemed a skin irritant if the
criteria are met in Table A.2.2 in at least two animals, rather than
one (Document ID 0322, Att. 2, p. 4). OSHA notes that the HCS skin
irritation classification criteria align with the current criteria used
for classification of skin irritation in the GHS reference tests where
irritant responses are present in two of three tested animals.
Regardless, to the extent Cal/OSHA seeks a modification in the criteria
in Table A.2.2, such changes were not proposed in the NPRM and thus
would be beyond the scope of this rulemaking.
As previously explained, OSHA is introducing changes to the final
rule which align with Rev. 8. To that end OSHA has added additional
paragraphs to Appendix A.2 in the final rule. New paragraph A.2.2.3
provides information on classification based on in vitro/ex vivo data.
New paragraph A.2.2.4 provides information on classification based on
other existing skin data in animals. New paragraph A.2.2.5 includes
information on classification based on chemical properties. New
paragraph A.2.2.6 includes information on classification based on non-
test methods. New paragraph A.2.2.7 outlines the approach to evaluation
of information that should be considered. In addition, Figure A.2.1 was
updated to make it consistent with the text and to show the tiered
evaluation process.
PCRM supported adding these sections, specifically highlighting the
revised Figure 3.2.1 and Sections 3.2.2.3, Classification based on in
vitro/ex vivo data, and 3.2.2.6, Classification based on non-test
methods (Document ID 0295, pp. 1-2).
Cal/OSHA commented that the phrase ``buffering capacity'' in
paragraph A.2.3.5 is used inconsistently in paragraph A.2.3.5, and is
not defined in the chapter, nor is the term ``acid/alkaline reserve''
(Document ID 0322, Att. 2, p. 5). Due to the changes made to align with
Rev. 8, the content Cal/OSHA is referring to is now in A.2.2.5. OSHA
intends to update some of its existing compliance assistance products
following the publication of the final rule and anticipates providing
further guidance on acid/alkaline reserve (buffering capacity).
Paragraph A.2.3 (proposed as A.2.4) provides information on
classification criteria for mixtures. OSHA had proposed changes to
align with Rev. 7, including changes to proposed A.2.4.1.1 and
A.2.4.1.2. As with the other classification criteria in A.2, in this
final rule OSHA is aligning this section with Rev. 8 instead.
Therefore, OSHA is updating A.2.3.1.1 (proposed as A.2.4.1.1) and
A.2.3.1.3 (proposed as A.2.4.1.2) and adding a new paragraph A.2.3.1.2.
In the new A.2.3.1.1, OSHA is including language stating that the
tiered approach specified in Figure A.2.1 must be taken into account
when evaluating mixtures. New paragraph A.2.3.1.2 provides information
on using in vitro/ex vivo data and limitations regarding applicability
domains. The new A.2.3.1.3 is also included to indicate that if there
are no other data on the mixture besides pH, and the pH is extreme (pH
<=2 or pH >=11.5), that information is sufficient to classify the
mixture as corrosive to the skin. However, if the acid/alkaline reserve
suggests that the mixture may not be corrosive despite the extreme pH,
then this needs to be confirmed by other data.
OSHA also proposed to include a new note to Table A.2.3,
``Concentration of ingredients of a mixture classified as skin Category
1 or 2 that would trigger classification of the mixture as hazardous to
skin (Category 1 or 2),'' to indicate how to classify the mixture when
data are available for sub-categorization of Category 1. The proposed
note was to align with the note to Table 3.2.3 in Rev. 7 (Document ID
0060, p. 133), in order to provide information OSHA believes will be
useful for classifiers. OSHA received no comments on this proposed
note, and is finalizing it as proposed except to remove the phrase
``data are available and'' to align with Rev. 8 as discussed previously
(Document ID 0065, p. 136).
ACC suggested that OSHA consider adding Tables 3.2.6 and 3.2.7 from
the GHS to either the standard or an updated guidance document
(Document ID 0347, p. 6). OSHA anticipates updating some of its
guidance products following the publication of the final rule and
providing relevant guidance, including the content of Tables 3.2.6,
Skin corrosion criteria for in vitro/ex vivo methods, and 3.2.7, Skin
irritation criteria for in vitro methods from Rev. 8, as well as
references to NIOSH's Current Intelligence Bulletin and/or other
relevant NIOSH guidance.
For the reasons discussed above, OSHA is finalizing Appendix A.2 to
align with Rev. 8 in several respects, including the changes to
numbering and wording, and the additional paragraphs described above.
In Appendix A.3, OSHA proposed updates to align with Rev. 7. API
supported these changes and noted that they were in alignment with the
GHS (Document ID 0316, p. 19).
OSHA proposed to modify A.3.1.2 to clarify the sequence in which
data should be evaluated when classifying for serious eye damage/eye
irritation using a tiered evaluation approach. The proposed revision
was to align the language in this paragraph with the tiered approach in
Figure A.3.1. The first tier is existing human data, followed by
existing animal data, followed by in vitro data, and then other sources
of information. OSHA received no comments on this change, and is
finalizing it as proposed.
The changes OSHA proposed in paragraphs A.3.2 and A.3.3, including
Tables A.3.1 and A.3.2, are mainly editorial in nature. The
classification criteria in these paragraphs would remain the same, but
the proposed revisions rearrange the presentation of the information
and include additional headings to provide a clearer, more logical
sequence. All of the proposed changes were to conform with Rev. 7
(Document ID 0060, pp. 139-145).
OSHA proposed a new paragraph A.3.2 to provide a summary of the
classification criteria for substances that is provided in Tables A.3.1
and A.3.2. Paragraph A.3.2.3 of the 2012 HCS (now renumbered as
A.3.2.1.3) provided that if there is pronounced variability among
animal responses, that information
``may be taken into account'' when determining the classification.
Worksafe and Cal/OSHA commented that the language in the 2012 HCS would
allow producers to withhold evidence of a serious health effect in
toxicological studies if the effect occurs among a range of other
effects (Document ID 0354, p. 4; 0322, Att. 1, p. 3). While Worksafe
and Cal/OSHA incorrectly suggest that this is a new problem with the
language, since the word ``may'' was already in the 2012 HCS, OSHA
agrees with these comments and has concluded that making a change would
be consistent with the editorial and clarifying nature of the edits
OSHA proposed for A.3.2 and A.3.3 and the broader goal of this update
to Appendix A to clarify which elements are mandatory. The agency has
therefore revised proposed paragraph A.3.2.1.3 in the final rule to
indicate that the provision is mandatory and that information on
pronounced variability ``must'' be taken into account when making
classification decisions.
OSHA received a comment from Cal/OSHA asking why two out of three
test animals are required for category 1(b) while only one positive
test is required in (a). Additionally, they stated the text in the
table is unclear about the meaning of irreversible effects (Document ID
0322, p. 5). While OSHA proposed to modify the title and added a
footnote to Table A.3.1, OSHA did not propose to modify the actual
criteria and they remain consistent with the GHS. Therefore, this
comment is outside the scope of this rulemaking.
OSHA proposed a new paragraph A.3.3.6 (now A.3.2.2.6 in the final
rule) as a reorganization of the 2012 HCS paragraphs A.3.3.3 and
A.3.3.4. Proposed paragraph A.3.3.6 (now A.3.2.2.6) was to provide
guidance on using the tiered approach and making weight-of-evidence
decisions, and also to indicate OSHA's preference for not conducting
new animal tests. OSHA received no comments on proposed paragraph
A.3.3.6 (now A.3.2.2.6), and is therefore finalizing it as proposed.
OSHA proposed to modify Figure A.3.1 to align with the tiered
evaluation scheme in Figure 3.3.1 of Rev. 7 (Document ID 0060, p. 142).
Under OSHA's proposed revisions, Figure A.3.1, ``Tiered Evaluation for
serious eye damage and eye irritation'' (previously titled ``Evaluation
strategy for serious eye damage and eye irritation'' in the 2012 HCS),
would remain largely the same. However, as in Figure A.2.1, OSHA
proposed to revise Steps 1a, 1b, and 1c to clarify that the parameter
being evaluated is existing human or animal serious eye damage/eye
irritation data. In addition, OSHA proposed to modify the finding in
Step 4 to clarify that high acid/alkaline reserve or no data for acid/
alkaline reserve should be considered when the pH is <=2 or >=11.5.
OSHA also proposed modifications to the footnotes of Figure A.3.1 to
reflect the most recent test methods. Specifically:
OSHA proposed to include two additional sentences in
footnote c (previously footnote (3)) that emphasizes that expert
judgement should be exercised when making determinations from existing
animal data indicating serious eye damage/eye irritation, as not all
skin irritants are eye irritants.
OSHA proposed to include OECD Test Guideline 460
(Fluorescein leakage (FL)) in footnote d (previously footnote (4)) as
an additional example of an internationally accepted, scientifically
validated test method for identifying eye corrosives and severe
irritants. OSHA also proposed an additional sentence for this footnote
to indicate that there are presently no scientifically validated and
internationally accepted in vitro test methods for identifying eye
irritation.
OSHA proposed to revise footnote f (previously footnote
(6)) to make it clear that all available information on a substance
must (instead of should) be considered in making a determination based
on the total weight of evidence. In addition, OSHA proposed to remove
the last two sentences at the end of footnote f and add a new sentence
indicating that negative results from applicable scientifically
validated in vitro tests are considered in the total weight of evidence
evaluation.
PCRM supported updating the footnotes for Figure A.3.1 (Document ID
0295, p. 2). OSHA received no other comments on the changes to Figure
A.3.1 and is therefore finalizing them as proposed.
In proposed paragraph A.3.4 (now A.3.3 in the final rule), OSHA
proposed several minor editorial changes to ensure consistency in the
terminology used. For example, OSHA proposed to use the term ``serious
eye damage'' (rather than ``eye corrosion'') throughout the text to
reflect the name of the hazard class. OSHA received no comments on
these revisions and is therefore finalizing them as proposed.
For the reasons discussed above, OSHA is finalizing the entirety of
A.3 as proposed, except for changing ``may'' to ``must'' in A.3.2.3 and
renumbering some of the paragraphs to better align with the GHS.
IV. Respiratory or Skin Sensitization (Appendix A.4)
OSHA proposed a small number of primarily editorial changes in
Appendix A.4, Respiratory or Skin Sensitization. It received no
comments on those changes, but did receive an out of scope comment on
this section.
Cal/OSHA commented that in paragraph A.4.2.1.3.1, ``[t]he proposal
requires disclosure of chemical asthmagens that cause respiratory
sensitization, but does not require disclosure of chemicals that
produce bronchospasm without a sensitization (immune) effect, also
known as reactive airway dysfunction syndrome (RADS), or acute-onset,
irritant induced asthma (IIA)'' (Document ID 0322, Att. 1, pp. 17-18).
Cal/OSHA therefore recommended adding a category 1C to this hazard
class (Document ID 0322, Att. 2, p. 6). OSHA notes that the agency did
not propose to modify paragraph A.4.2.1.3.1, therefore, Cal/OSHA's
proposal is outside the scope of this rulemaking. Additionally, as
stated above, OSHA has provided considerable guidance on each hazard
category under its Hazard Classification guidance (Document ID 0008).
In this case, OSHA's classification guidance covers organ dysfunction,
such as RADS, under the hazard classes STOT-SE and STOT-RE (Document ID
0008, pp. 192, 213).
V. Germ Cell Mutagenicity (Appendix A.5)
As discussed below, OSHA proposed to add a definition for germ cell
mutagenicity in A.5.1.1. Because of this new paragraph, OSHA also
proposed adjusting the subsequent numbering of existing paragraphs in
A.5.1. OSHA received no comments on these changes and is finalizing
them as proposed.
In A.5.4, Examples of scientifically validated test methods,
paragraph A.5.4.2, OSHA proposed to delete the Mouse spot test (OECD
484) as an example of an in vivo somatic cell mutagenicity test, as it
was deleted by the OECD on April 2, 2014. The proposed change was to
align with Rev. 7 (Document ID 0060, p. 163) and to ensure that hazard
classifications are being conducted with the most current scientific
principles. OSHA received no comments on this revision and is therefore
finalizing it as proposed.
Toby Threet stated that Figure A.5.1 ``should not place all human
epidemiological studies on an equal footing. Sometimes an
epidemiological study, by itself, is not sufficient to establish that a
chemical is a known human germ cell mutagen'' and proposed modified
text (Document ID
0279, p 16). OSHA did not propose to modify Figure A.5.1; therefore,
the proposed revision is out of scope for this rulemaking and OSHA
declines to change the text as requested.
VI. Carcinogenicity (Appendix A.6)
Paragraph A.6.4.2 indicates that when OSHA has identified a
chemical as a carcinogen in 29 CFR part 1910, subpart Z, Toxic and
Hazardous Substances, that chemical must be classified as a carcinogen
for purposes of the HCS (for instance, the respirable crystalline
silica standard references the HCS and silica being a carcinogen in 29
CFR 1910.1053(j)(1)). OSHA proposed to strike the specific citation to
29 CFR part 1910, subpart Z, Toxic and Hazardous Substances, and
replace it with the text ``this section subpart.'' Toby Threet and the
Vinyl Institute stated that the proposed text was unclear, and the
Vinyl Institute commented that the reason for the revision was vague
(Document ID 0279, p. 17; 0369, p. 10). OSHA included the text
``section subpart'' in error in the NPRM. The proposed text should have
replaced the citation to 29 CFR part 1910, subpart Z, Toxic and
Hazardous Substances with the text ``this subpart.'' However, OSHA
agrees with these comments and is retaining the original text for
clarity.
Cal/HESIS, Cal/OSHA, Worksafe, National COSH, and Steve Wodka
commented that manufacturers should be required to classify chemicals
as carcinogens and provide carcinogenicity information when the
chemical is listed as a carcinogen by authoritative organizations. Cal/
HESIS specified these should include ``the NTP, the IARC, the EPA, and
OSHA when OSHA has included cancer as a health hazard to be considered
by classifiers for the chemical under 29 CFR part 1910, subpart Z,
Toxic and Hazardous Substances'' (Document ID 0313, pp. 6-7). Some of
these commenters provided suggested text for paragraph A.6.4 (Document
ID 0313, pp. 6-7; 0312, p. 6; 0322, Att. 1, pp. 5-7; 0354, pp. 5-6;
0407, p. 15). OSHA did not propose to modify the paragraphs that Cal/
HESIS proposed revisions to (except to use the term ``of this subpart''
in A.6.4, which is unrelated to this issue). Therefore, the suggested
revisions are out of scope for this rulemaking and OSHA declines to
make those changes. Furthermore, OSHA provides ample guidance in both
Appendix F, which includes a table on how to classify carcinogens based
on NTP and the International Agency for Research on Cancer (IARC)
classifications, and Appendix C of the compliance directive (Document
ID 0007, p. 103) which OSHA anticipates updating after issuing this
final rule.
Cal/HESIS also commented that OSHA should ``allow State Plan States
such as California to require manufacturers that sell chemicals in
their states or territories to classify chemicals as carcinogens or as
having reproductive toxicity or developmental toxicity when the
chemicals are listed by a state- or territory-specific body. . . as
carcinogens or as reproductive or developmental toxicants'' (Document
ID 0313, p. 8). This issue is outside the scope of this rulemaking as
OSHA proposed nothing related to this issue in the NPRM. However, OSHA
notes that it has already addressed the issue of labeling of hazardous
chemicals in its 1997 approval of the California State Standard on
Hazard Communication Incorporating Proposition 65 (Prop 65) (62 FR
31159).
VII. Reproductive Toxicity (Appendix A.7)
In Appendix A.7, OSHA proposed to revise the ``effects on or via
lactation'' hazard category classification criteria in Figure A.7.1(b)
to align with OSHA's Hazard Classification guidance (Document 0008, p.
172). During the development of the Hazard Classification guidance
document, it became apparent to OSHA that there were issues with regard
to the classification criteria in Figure A.7.1(b). The hazard category
for effects on or via lactation captures two separate effects: (1)
substances that can interfere with lactation and (2) substances and
their metabolites that may be transmitted through breast milk to
children in amounts sufficient to cause concern for the health of the
breastfeeding child. However, the criteria in effect at that time did
not adequately distinguish between these two separate effects. OSHA
therefore proposed to delete the text ``hazardous to breastfed babies''
in the second sentence in Figure A.7.1(b), which was not grammatical
and excluded the effects on lactation. OSHA also proposed to modify the
third sentence in the figure to read: ``Classification for effects via
lactation shall be assigned on the basis of:'' in order to avoid
confusion on how to apply the criteria for effects on lactation. These
proposed changes would not affect the classification of substances or
mixtures as reproductive toxicants. OSHA received no comments on this
revision and is therefore finalizing it as proposed.
OSHA also proposed to modify paragraph A.7.2.5.1 to include OECD
Test Guideline 443, Extended One Generation Reproductive Toxicity
Study, as an additional method for one or two generation toxicity
testing. Additionally, in Table A.7.1 ``Cut-off values/concentration
limits of ingredients of a mixture classified as reproductive toxicants
or for effects on or via lactation that trigger classification of the
mixture,'' OSHA proposed a correction to the top left heading from
``ingredients classified as'' to ``ingredient classified as.'' OSHA
explained in the NPRM that the use of the word ``ingredients'' in this
context could be confusing, as it could suggest that the additivity
principle should be applied. Therefore, OSHA proposed this change for
clarity. These proposed modifications in Appendix A.7 were to align
with Rev. 7 (Document ID 0060, pp. 185-187). OSHA received one comment
from PCRM in support of the addition of OECD TG 443, and no comments
objecting to its addition. OSHA is therefore finalizing these changes
as proposed.
Cal/HESIS commented that OSHA should add a requirement that
manufacturers refer to authoritative organizations when classifying
chemicals that have reproductive toxicity as follows: ``Manufacturers
classifying chemicals shall treat the following source as establishing
that a substance is a reproductive or developmental toxicant for hazard
communication purposes in lieu of applying the criteria described
herein: 1. Reproductive or developmental toxicants identified in the
Monographs on the Potential Human Reproductive and Developmental
Effects, National Toxicology Program, Office of Health Assessment and
Translation'' (Document ID 0313, p. 6). OSHA did not propose any
modifications to the classification criteria in Appendix A.7 related to
authoritative organizations when classifying chemicals that have
reproductive toxicity, therefore, Cal/HESIS's comment is therefore
outside the scope of this rulemaking and OSHA declines to accept their
proposal.
VIII. Specific Target Organ Toxicity Single Exposure (Appendix A.8)
In addition to non-substantive changes in A.8.1.6 and A.8.2.1.7.3,
OSHA proposed adding new paragraph A.8.3.4.6 to include the concept of
``relevant ingredient'' when classifying mixtures containing Category 3
ingredients using the additivity approach. Under the 2012 HCS, the
additivity principle was introduced in paragraph A.8.3.4.5. However, a
``relevant ingredient'' for this procedure had not been established.
OSHA therefore proposed paragraph A.8.3.4.6 to provide that in cases
where the
additivity approach is used for Category 3 ingredients, the ``relevant
ingredients'' of a mixture are those which are present in
concentrations >= one percent (w/w for solids, liquids, dusts, mists,
and vapors and v/v for gases), unless there is a reason to suspect that
an ingredient present at a concentration < one percent is still
relevant when classifying the mixture for respiratory tract irritation
or narcotic effects. This proposed paragraph would align with Rev. 7
(Document ID 0060, p. 198). OSHA received no comments on these
revisions and is finalizing them as proposed.
OSHA received a comment from Toby Threet arguing that in Tables
A.8.1, A.9.1, A.9.2, and paragraph A.8.3.4.6, the use of the words
``gas,'' ``vapor,'' and ``mist'' as three distinct categories is
scientifically incorrect and that either ``gas'' and ``vapor'' are
synonymous or ``vapor'' and ``mist'' are synonymous, depending on
OSHA's intended meaning of ``vapor.'' Threet suggested that OSHA modify
these sections to only have two categories (Document ID 0279, p. 17).
OSHA notes that the agency did not propose to modify the use of these
three terms in Tables A.8.1, A.9.1, or A.9.2 or how those terms are
used more generally in the HCS, and A.8.3.4.6, while new, reflects that
underlying concept. Therefore, such changes would be out of scope for
this rulemaking. OSHA notes that its Hazard Classification guidance
provides substantial guidance and examples regarding how to apply the
hazard criteria to vapors, mists, and gases (Document ID 0008, pp. 189-
226).
IX. Specific Target Organ Toxicity Repeated or Prolonged Exposure
(Appendix A.9)
OSHA made a few changes to Appendix A.9 that are discussed below in
the section on broader changes made throughout Appendix A. OSHA
received one comment on Appendix A.9 unrelated to its proposed changes.
Cal/HESIS commented that OSHA should add the following requirement:
``For chemicals that affect the nervous system, manufacturers shall
treat the following sources as establishing that a substance is a
neurotoxicant for hazard communication purposes in lieu of applying the
criteria described herein: 1. Agency for Toxic Substances and Disease
Registry (ATSDR), Health Effects of Toxic Substances and Carcinogens,
Nervous System. 2. Chemicals for which a reference dose or
concentration has been developed based on neurotoxicity in the United
States Environmental Protection Agency's Integrated Risk Information
System database (searching for ``Organ/System affected: Nervous'')''
(Document ID 0313, pp. 7-8). While OSHA agrees that these sources are
relevant and the classifiers can rely on this information for
classification purposes, OSHA did not propose to modify the
classification criteria in Appendix A.9 to include a requirement that
manufacturers refer to authoritative organizations when classifying
chemicals that have specific target organ toxicity, therefore, it is
outside the scope of this rulemaking to modify Appendix A.9 as
suggested by Cal/HESIS.
X. Aspiration Hazard (Appendix A.10)
OSHA proposed changes to Appendix A.10 to clarify the
classification criteria for mixtures when data are available for all
ingredients or only for some ingredients and to align with Rev. 7
(Document ID 0060, p. 213). OSHA proposed new paragraph A.10.3.3.1 to
clarify that the concept of ``relevant ingredient'' applies and that
relevant ingredients are those that are present in concentrations of at
least 1%. In addition, OSHA proposed a new heading, ``Category 1,'' as
new paragraph A.10.3.3.2. and proposed paragraphs A.10.3.3.2.1 and
A.10.3.3.2.2 to clarify that the principle of additivity applies in
Appendix A.10. OSHA did not propose any substantive changes to the
classification criteria. ILMA commented in support of the changes in
A.10.3.3, stating that the clarifications provided ``will assist ILMA
members (many of whom compound and market low-viscosity petroleum
product mixtures) in properly classifying their products for aspiration
toxicity'' (Document ID 0356, p, 6). OSHA received no objections to the
changes and is finalizing them as proposed.
XI. Changes to Definitions and Terminology, Clarification of Mandatory
Requirements, and Corrections
(A) Definitions
OSHA proposed to update Appendix A to include changes to the health
hazard definitions to reflect those adopted in Rev. 7 (Document ID
0060; 0131). In the time since OSHA revised the HCS in 2012, the
UNSCEGHS revised all of the health hazard definitions in the GHS. The
previous health hazard definitions were not consistent with respect to
form or content, and many of the definitions were taken directly from
the OECD test guidelines.
The UNSCEGHS determined that the definitions should be more general
and neutral with respect to test guidelines and that test guideline
criteria should not be part of a definition. The group also determined
that the health hazard definitions should be clear and concise and that
there should be a clear differentiation between ``definitions'' and
``general considerations'' text. OSHA proposed to adopt all the revised
health hazard definitions from Rev. 7 in Appendix A, as well as
corresponding changes to text throughout the appendix. For example, in
some cases OSHA proposed to remove OECD test guidelines from
definitions and to move them to paragraphs outlining classification
criteria. OSHA has discussed in the respective sections above the
definition changes that had substantive impacts on the rest of their
hazard classifications and has made alterations to some of the proposed
definitions. These health hazard definitions are the definitions that
OSHA is finalizing in Appendix A:
Acute toxicity refers to serious adverse health effects
(i.e., lethality) occurring after a single or short-term oral, dermal,
or inhalation exposure to a substance or mixture.
Skin corrosion refers to the production of irreversible
damage to the skin; namely, visible necrosis through the epidermis and
into the dermis occurring after initial exposure to a substance or
mixture.
Skin irritation refers to the production of reversible
damage to the skin occurring after initial exposure to a substance or
mixture.
Serious eye damage refers to the production of tissue
damage in the eye, or serious physical decay of vision, which is not
fully reversible, occurring after exposure of the eye to a substance or
mixture.
Eye irritation refers to the production of changes in the
eye, which are fully reversible, occurring after exposure of the eye to
a substance or mixture.
Respiratory sensitization refers to hypersensitivity of
the airways occurring after inhalation of a substance or mixture.
Skin sensitization refers to an allergic response
occurring after skin contact with a substance or mixture.
Germ cell mutagenicity refers to heritable gene mutations,
including heritable structural and numerical chromosome aberrations in
germ cells occurring after exposure to a substance or mixture.
Carcinogenicity refers to the induction of cancer or an
increase in the incidence of cancer occurring after exposure to a
substance or mixture. Substances and mixtures which have induced benign
and malignant tumors in well-performed experimental studies
on animals are considered also to be presumed or suspected human
carcinogens unless there is strong evidence that the mechanism of tumor
formation is not relevant for humans.
Reproductive toxicity refers to adverse effects on sexual
function and fertility in adult males and females, as well as
developmental toxicity in the offspring, occurring after exposure to a
substance or mixture. Some reproductive toxic effects cannot be clearly
assigned to either impairment of sexual function and fertility or to
developmental toxicity. Nonetheless, substances and mixtures with these
effects shall be classified as reproductive toxicants.
Specific target organ toxicity--single exposure (STOT-SE)
refers to specific, non-lethal toxic effects on target organs occurring
after a single exposure to a substance or mixture. All significant
health effects that can impair function, both reversible and
irreversible, immediate and/or delayed and not specifically addressed
in A.1 to A.7 and A.10 of this Appendix are included. Specific target
organ toxicity following repeated exposure is classified in accordance
with SPECIFIC TARGET ORGAN TOXICITY--REPEATED EXPOSURE (A.9 of this
Appendix) and is therefore not included here.
Specific target organ toxicity--repeated exposure (STOT-
RE) refers to specific toxic effects on target organs occurring after
repeated exposure to a substance or mixture. All significant health
effects that can impair function, both reversible and irreversible,
immediate and/or delayed and not specifically addressed in A.1 to A.7
and A.10 of this Appendix are included. Specific target organ toxicity
following a single-event exposure is classified in accordance with
SPECIFIC TARGET ORGAN TOXICITY--SINGLE EXPOSURE (A.8 of this Appendix)
and is therefore not included here.
Aspiration hazard refers to severe acute effects such as
chemical pneumonia, pulmonary injury or death occurring after
aspiration of a substance or mixture.
Aspiration means the entry of a liquid or solid chemical
directly through the oral or nasal cavity, or indirectly from vomiting,
into the trachea and lower respiratory system.
NAIMA and API commented in support of the proposed modifications to
the health hazard definitions (Document ID 0338, p. 7; 0316, p. 12).
OSHA received comments on some of the specific definitions, which are
addressed in their respective sections (including acute toxicity, skin
corrosion, and skin irritation definitions) and the definitions listed
above include any responsive modifications OSHA decided to make based
on those comments. OSHA received no objections to the changes to the
serious eye damage, eye irritation, respiratory sensitization, skin
sensitization, germ cell mutagenicity, carcinogenicity, reproductive
toxicity, STOT-SE, and STOT-RE definitions, and is therefore finalizing
these definitions as proposed.
(B) Terminology Issues
The 2012 HCS was somewhat inconsistent in the way the terms
``hazard category'' and ``toxicity category'' were used throughout
Appendix A. In some cases, the terms were used interchangeably, while
in other instances the terms were intended to have different meanings.
OSHA therefore proposed revisions to ensure that these terms are used
appropriately and consistently. As such, OSHA proposed to delete the
term ``toxicity category'' and replace it with ``hazard category'' in
various places, including paragraphs A.0.5, A.1, A.3, A.8, A.9, and
A.10. These proposed changes also align with Rev. 7 (Document ID 0060;
0084). OSHA received no comments on these changes and is finalizing
them as proposed.
(A) Mandatory Language
OSHA proposed to update a number of provisions in Appendix A to
make it clear that those provisions are mandatory. For example, OSHA
proposed to change the term ``should'' to ``must'' in paragraph
A.3.4.3.3 (now paragraph A.3.3.3.3) to clarify that the cut-off value/
concentrations in Table A.3.3 are mandatory when determining if a
mixture must be classified as seriously damaging to the eye or an eye
irritant. OSHA received no comments on these changes and is finalizing
them as proposed.
(B) Corrections
OSHA proposed to correct a few errors that currently exist in the
HCS. OSHA erroneously did not include Appendix A.4, respiratory or skin
sensitization, in the list of health hazards referenced in the
``concentration of mixtures'' paragraph at A.0.5.1.3 of the 2012 HCS.
OSHA therefore proposed to add a reference to Appendix A.4 in paragraph
A.0.5.1.3 to clarify that the concentration of mixtures bridging
principle applies to respiratory and skin sensitization. Similarly,
Appendix A.4 was also erroneously excluded from the list of health
hazards referenced in the ``interpolation within one toxicity
category'' paragraph at A.0.5.1.4 of the 2012 HCS. Thus, OSHA also
proposed to add a reference to Appendix A.4 in paragraph A.0.5.1.4 to
clarify that the interpolation bridging principle applies to
respiratory and skin sensitization. OSHA received no comments on these
changes and is finalizing them as proposed.
D. Appendix B
Appendix B addresses the physical hazards covered by the HCS,
including classification criteria consistent with the GHS. OSHA
proposed several substantive updates to Appendix B, including the
addition of a new hazard class (desensitized explosives) and several
new hazard categories (splitting Category 1 into 1A and 1B and further
subdividing Category 1A into flammable gases, chemically unstable gases
and pyrophoric gases in the Flammable Gases class, as well as
nonflammable aerosols in the Aerosols class), revisions to the
consensus standards and testing methods referenced in Appendix B, and
clarifications based on implementation issues that arose from the 2012
HCS.
OSHA proposed to include the new hazard class and hazard categories
because, since the HCS aligned with the GHS in 2012, new physical
hazard classes or hazard categories have been added to Rev. 7 which
better identify and communicate hazard information to downstream
workers (Document ID 0060). OSHA proposed to adopt those additions to
maintain alignment with the GHS. As explained in the NPRM and in the
discussion to follow on individual classes within Appendix B, OSHA
preliminarily determined that the addition of these specific hazard
classes and categories would better differentiate between the hazards
and better communicate hazards on labels for downstream users by using
more targeted hazard statements, precautionary statements, and
pictograms.
In order to maintain alignment with Rev. 7 (Document ID 0060), OSHA
also proposed several updates to references to consensus standards and
testing methods. Although the HCS does not require testing and permits
classifiers to use data from literature or experience for
classification purposes, OSHA proposed to update consensus standards
and testing methods referenced in Appendix B in accordance with Rev. 7
to ensure that data considered for classification incorporate updated
scientific principles. OSHA is not, however, implying that data
obtained from the older methods would no longer be valid or that
classifiers would need to retest or reclassify chemicals due to
these updated methods. Third, OSHA proposed certain corrections and
clarifications to Appendix B to address (1) previous inadvertent
omissions from the GHS or the HCS; (2) changes made to the GHS to
improve clarity or technical accuracy; and (3) how some hazard classes
should be evaluated in light of the addition of new hazard classes in
the GHS. These changes, discussed further below, were proposed to align
the HCS with the GHS while improving the classification and
communication of hazards[thinsp]and maintaining or enhancing worker
safety and health. As noted elsewhere in this preamble, OSHA has
determined that primarily aligning the HCS with Rev. 7 will not only
improve safety and health but will also ease compliance burdens for
U.S. stakeholders that must also comply with international requirements
for hazard classification and communication.
OSHA also proposed to make several changes to Appendix B to clarify
compliance requirements. These changes arose from the agency's
experience with implementing the HCS and are expected to maintain
existing safety and health protections while easing or having no effect
on the compliance burdens for regulated entities. They are described in
more detail in the discussions below on individual classes within
Appendix B.
Finally, OSHA provided a redline strike out version of Appendix B,
which reflected all of OSHA's proposed revisions, in the docket and on
the OSHA website to allow interested parties to view all of the
proposed changes in context (Document ID 0222). OSHA will update this
document to show the changes being made in this final rule and strongly
encourages stakeholders to review that document in conjunction with the
discussion of the revisions, as the discussion provided in this final
rule's summary and explanation does not fully describe all of the non-
substantive or editorial changes OSHA is making in Appendix B.
Stakeholders can examine the redline strikeout of the regulatory text
(changes from 2012 HCS to this final rule) at OSHA's HCS web page
(https://www.osha.gov/dsg/hazcom/) to view all of the changes from the
2012 HCS made in this final rule.
I. Explosives (Appendix B.1)
OSHA proposed several minor amendments to Appendix B.1. First, OSHA
proposed a clarification to the classification criteria for Division
1.6 explosives in B.1.2 (f). Under Rev. 3, one of the criteria for
classification of an article (OSHA uses the term ``item'' in the HCS)
as a Division 1.6 explosive is that it contains ``only'' extremely
insensitive detonating chemicals (Document ID 0085, Att. 2, p. 4). Rev.
7 (Document ID 0060, p. 44) states that the criteria are met if the
article (``item'' in the HCS) ``predominantly'' contains extremely
insensitive detonating chemicals. OSHA proposed to make the same change
to paragraph B.1.2 (f) of Appendix B on the basis that changing the
criteria from containing ``only'' extremely insensitive detonating
chemicals to ``predominantly'' containing extremely insensitive
detonating chemicals would be more technically accurate and better
align with the guidance in test series 7 in the UN Manual of Tests and
Criteria (Document ID 0151). It would also reduce confusion for
chemical manufacturers or importers when classifying explosives. OSHA
did not receive any comments on this change and is finalizing it as
proposed.
OSHA also proposed to add two notes from the GHS (Document ID 0060,
pp. 44-45) to Appendix B, paragraph B.1.3.1, that are related to the
addition of the desensitized explosives hazards class (Appendix B.17,
newly added in this final rule and discussed later in this document).
The first new note OSHA proposed to add (Note 2) provides an
explanation that explosives for which explosive properties have been
suppressed or reduced by being wetted with water or alcohols, diluted
with other substances, or dissolved or suspended in water or other
liquid substances must be classified as desensitized explosives.
The second new note OSHA proposed (Note 3) explains that some
chemicals that are exempt from classification as explosives under UN
Recommendations on the Transport of Dangerous Goods guidelines still
have explosive properties, which must be communicated in Section 2
(Hazard identification) and Section 9 (Physical and chemical
properties) of the SDS, as appropriate. OSHA proposed that the notes
would be incorporated in the HCS with edits to change these provisions
from recommendations in the GHS to requirements in the HCS (e.g., ``may
be a candidate for classification as'' in the GHS would be revised to
``shall be classified as'' in the HCS) and to revise the GHS
terminology to terminology more appropriate for the HCS (e.g.,
``substances and mixtures'' in the GHS would be revised to
``chemicals'' in the HCS).
OSHA received comments on proposed Note 2 from DOD. DOD stated that
``The techniques cited in B.1.3.1. . .do not necessarily `suppress or
reduce explosive properties' as indicated within NOTE 2. Instead, those
techniques simply result in sensitivity suppression or reduction by
homogeneously dispersing certain concerning molecules amongst other
inert molecules, which is why the resultant chemicals are known as
`desensitized explosives' '' (Document ID 0299, p. 3). DOD recommended
that OSHA change the first sentence of Note 2 to read: ``Some explosive
chemicals are wetted with water or alcohols, diluted with other
substances, or dissolved or suspended in water or other liquid
substances, to suppress or reduce their explosive properties or
sensitivity'' (Document ID 0299, p. 3; emphasis added).
OSHA believes the language proposed in the NPRM captured the idea
of a reduction of sensitivity in the phrase ``suppress or reduce their
explosive properties.'' However, to ensure clarity, OSHA has added the
term ``sensitivity'' at the end of the first sentence of Note 2 as DOD
requested.
DOD additionally recommended that OSHA should address the concept
of desensitizing an explosive by mixing it with an inert solid (e.g.,
silica) in Note 2 (Document ID 0299, p. 3). OSHA does not agree that
this addition is necessary. The primary purpose of this note is to
alert the classifier that a mixture may be a desensitized explosive and
that they should consider this in their classification process. The
note is not intended to give guidance on how to dilute an explosive to
become desensitized or list every mechanism by which such
desensitization can be achieved. OSHA notes that mixing explosives with
solids is not excluded from this note because it includes the phrase
``diluted with other substances.'' Additionally, this wording matches
the wording in Rev. 7, which is reflected in both this proposed note
and proposed Section B.17, Desensitized Explosives. Furthermore, OSHA
notes that the addition of solids to explosive chemicals is not an
unequivocal abatement of the explosive hazard nor does it automatically
create a desensitized explosive. Under certain circumstances such an
addition would be a new mixture that may need to be reevaluated to
determine whether it is an explosive or desensitized explosive. OSHA
does not want to suggest that solids can in all cases be used to create
a desensitized explosive. Thus, OSHA is not adding the suggested edits
by DOD but anticipates providing additional information on this issue
as it updates its classification guidance.
DOD provided two suggestions for Note 3. First, DOD noted that
there is an
error in OSHA's citation of the is UN Recommendations on the Transport
of Dangerous Goods, Manual of Tests and Criteria and that it should be
to UN ST/SG/AC.10/11/Rev.6 instead of UN ST/SG AC.10/30/Rev.6. Second,
DOD recommended that OSHA add the phrase ``which are exempted from
classification as explosives (based on a negative result in Test Series
6 in Part I, Section 16, of UN ST/SG/AC.10/11/Rev.6)'' (Document ID
0299, pp. 3-4). OSHA agrees with both suggested revisions and notes
that DOD's second recommended change is in the Rev. 7 note which OSHA's
Note 3 was based on (Document ID 0060, p. 45, Note 2 under table
2.1.2). Therefore, OSHA is updating Note 3 as recommended by DOD.
OSHA received several comments from SAAMI. First, SAAMI commented
that, similar to OSHA's approach to changes from Rev. 8 of the GHS,
OSHA should provide an option in the final rule for industry to change
over to Rev. 9 for GHS chapter 2.1 (Document ID 0370, p. 2). However,
unlike the changes in Rev. 8, OSHA did not propose or raise as an issue
the potential to adopt Rev. 9 updates to chapter 2.1 in this final
rule. OSHA does not believe there has been sufficient notice and
comment to make such sweeping changes to this final rule. However,
while OSHA is not making a finding in this rulemaking that this will be
the case for every explosive, OSHA believes that under many
circumstances following the Rev. 9 update to chapter 2.1 will result in
full compliance with the requirements of the HCS, and manufacturers,
importers, and distributors can determine whether in a given case
following Rev. 9 would also comply with the HCS.
OSHA's conclusion is based on several factors unique to explosives.
First, OSHA notes that following Rev. 9 would meet the HCS requirement
to not use updated classification criteria from subsequent GHS
revisions. As illustrated by SAAMI's comparison spreadsheet (Document
ID 0294, Att. 2), which OSHA has reviewed and concluded is accurate,
the same TDG classification criteria are used. The categories are
simply called different names (e.g., Divisions 1.1-1.3 and 1.5 are now
called 2A, Division 1.4 is called 2B or 2C) and are regrouped to better
break down the classification into low, medium, and high hazards when
outside of the packaging. A label preparer could follow all of the
classification instructions in Appendix B and simply call it a
different category name as a result, which would not confuse workers
because the category name is not used on labels.
Second, explosives have unique flexibility under Appendix C with
regard to the language used on labels compared to other hazards and the
labeling language in Rev. 9 is generally quite similar to the language
used in Rev. 7. Specifically, in Appendix C, in the note under C.4.14,
if a label preparer determines that an unpackaged or repackaged
explosive corresponds to a hazard category other than Division 1.1,
OSHA allows the use of the corresponding symbol (i.e., pictogram),
signal word, and/or hazard statement. Since labels are attached to the
immediate container, which would be exposed when explosives are
unpackaged or repackaged, OSHA believes that it is often appropriate to
use this flexibility on HCS labels for explosives. OSHA therefore
believes that this provision, in combination with the usual
flexibilities regarding hazard statements under C.2.2.1 and C.2.2.2,
can allow the label preparer to determine, on a case-by-case basis,
that the hazard statements in Chapter 2.1 of Rev. 9 are appropriate.
Similarly, because deviations in precautionary statements between Rev.
7 and Rev. 9 are infrequent and usually small, OSHA believes that the
labeling flexibility under C.2.4 would allow for the use of
precautionary phrases from Rev. 9. OSHA would allow deviations in
labeling language, for both hazard statements and precautionary
statements, if the label preparer can show that based on their analysis
of the explosive the label elements in Rev. 9 are more appropriate and
therefore would be in full compliance with the HCS (see Appendix C,
C.2.2.2 and renumbered C.2.4.9). The hazard statements, pictograms and
signal words for explosives in Rev. 9 are all at least as protective as
the Rev. 7 elements that OSHA proposed to include in the updated HCS,
except for the low hazard explosives (Category 2C, which corresponds to
explosive 1.4S in Rev. 7 and the HCS) where an exclamation mark
pictogram is used instead of an exploding bomb (Document ID 0294, Att.
2). While there is no general flexibility regarding pictograms in
C.2.3, in Appendix C, Category 1.4S small arms and ammunition are
specifically exempted from the requirement to include a pictogram,
meaning that the pictogram requirements in the HCS and Rev. 9 are not
in conflict.
Considering all of the flexibilities outlined above, OSHA concludes
that a label preparer may, on a case-by-case basis, determine that
using the label elements prescribed in Rev. 9 for labeling explosives
would be in compliance with the HCS. OSHA also believes that this could
help harmonize labeling since Rev. 9 categorization gives labelers a
clearer path forward to an appropriate labeling scheme where explosives
are removed from their original packaging and the use of alternate
labeling elements are appropriate as allowed under the HCS. However,
OSHA is not making a finding in this rulemaking that it will be
appropriate to follow Rev. 9 in every case because this was not put
through notice and comment and the agency has not, therefore, had the
opportunity to consider every possibility that might cause a conflict
between the HCS and Rev. 9. Label preparers who wish to follow Rev. 9
in a given situation must carefully consider whether doing so will
comply with the HCS.
OSHA also received several comments regarding explosives that are
out of scope for this rulemaking. SAAMI commented about potential
confusion between the definitions of the term article in the HCS versus
in DOT regulations as they applied to ``explosive articles.'' SAAMI
noted that ``in the HCS, `explosive articles' are `items' rather than
`articles' and are thus covered by the HCS'' (Document ID 0294, p. 3).
They expressed concern that the term ``article'' is used in DOT
regulations, but has a different meaning than the term used in the HCS,
which could cause confusion since DOT articles may not be OSHA
articles. They suggested that OSHA should clarify the distinction ``in
the preamble of the final rule or in the HCS itself'' (Document ID
0294, p. 3).
OSHA did not propose any updates to the definition of article in
the NPRM, therefore this comment is out of scope for this rulemaking.
Furthermore, since OSHA does not use the term ``explosive article'' in
the HCS and has carefully delineated between ``articles'' and ``items''
as it pertains to explosives, the agency disagrees with SAAMI that the
differences between the DOT and HCS terms will cause confusion. OSHA
notes that in the 2012 update to the HCS, the agency was careful to
explain the difference between the long-standing definition of article
in the HCS and the term ``item'' when referring to explosives (77 FR
17722). OSHA will consider explaining, as suggested by SAAMI, the
terminology in the updated guidance products it will produce following
the promulgation of this final rule.
DOD also commented on the definition of article and argued that
paragraph 1.3.2.1.1 of Rev. 7 creates confusion regarding whether
explosives are covered by the HCS. They suggested
clarifying that explosive and pyrotechnic items, as defined in
paragraph B.1.1.1 of Appendix B, are within the definition of
``chemical.'' As stated above OSHA did not propose changes to the term
``article'' or ``chemical'', therefore this comment is out of scope for
this rulemaking. The agency also believes that under the regulatory
text of the HCS it is clear that all explosives are covered under the
HCS. However, OSHA will consider further clarifying that explosives are
covered as it updates guidance products to reflect this final rule.
OSHA also received a comment from Daniel Nicponski of Albany
Molecular, resubmitting his e-correspondence communication with OSHA
regarding his concern that the calculation in B.1.3.4 is incorrect
(Document ID 0304, p. 1). Because OSHA did not propose a change to this
formula, this comment is out of scope for this rulemaking. However, the
agency notes that this issue has been brought up in a variety of fora
including an OSHA and DOT Public meeting, the UN Subcommittee of
Experts on the Transport of Dangerous Goods (UNSCETDG) and the
International Group of Experts on the Explosion Risks of Unstable
Substances (IGUS) meeting. These discussions are ongoing and may result
in an update to the formula in a future revision of the GHS. If the GHS
decides to update the formula, OSHA will consider updating the formula
in B.1.3.4 in a subsequent rulemaking.
OSHA received a comment and supporting documents from Ben Barrett,
a private citizen, providing information for the docket documents that
identified potential inconsistencies and potential solutions for the
classification of unintentionally energetic substances in the UN Manual
of Tests and Criteria (Document ID 0463). These proposals are still
under consideration by the UN Subcommittee of Experts on the Transport
of Dangerous Goods and have yet to be incorporated into the manual.
Similar to the discussion above, Barrett's comment is not related to a
proposed change and is therefore out of scope for this rulemaking;
however, if the Manual of Tests and Criteria is updated in the future,
OSHA will consider incorporating by reference the updated version in a
subsequent rulemaking.
II. Flammable Gases (Appendix B.2)
OSHA proposed several changes to the Flammable Gases hazard class
(Appendix B.2). Most significantly, OSHA proposed to subdivide Category
1 of this class into two subcategories, 1A and 1B, and to specify that
pyrophoric gases and chemically unstable gases are to be classified as
Category 1A, in alignment with changes made in Rev. 7 (Document ID
0060, p. 53) since OSHA updated the HCS in 2012. As explained in the
NPRM, the proposed subcategories would provide downstream users with a
better understanding of the severity of the hazards associated with the
flammable gases in each category in order to take appropriate
precautions or determine if a substitute chemical is less hazardous.
Furthermore, OSHA noted that the proposed bifurcation (splitting
flammable gases Category 1 into Category 1A and 1B) would not alter
transportation requirements for flammable gases because all flammable
gases categorized as either 1A or 1B would still count as Category 1
flammable gases for the transportation classification and communication
scheme.
Most comments that OSHA received on this change supported the
proposal to subdivide Category 1 of the Flammable Gases hazard class.
Commenters supported this change for a variety of reasons, including
that it improves alignment with the GHS (Document ID 0316, pp. 21-22;
0366, p. 7), it will encourage the use of less harmful substances
(Document ID 0298, p. 1), and it will facilitate the transition to low
Global Warming Potential (GWP), lower flammability refrigerants which
will fit into the new GHS Category 1B classification (Document ID 0355,
pp. 1-2; 0311, pp. 1-2).
OSHA received one comment objecting to the proposal to split
flammable gases into subcategories. NPGA noted that similar federal
regulations, codes, and standards do not distinguish by categories of
flammability and argued that this is because it is inconsequential and
that employers, employees, or emergency responders do not apply
different handling or safeguard protocols to `extremely flammable'
products compared to `flammable' products. Additionally, they asserted
that the agency's discussion in the NPRM indicated an ambition to
direct chemical choices for purposes they consider to be beyond the
scope of the HCS. They asked the agency to consider eliminating
distinctions in flammability and promulgate one flammability hazard
statement for a single category of flammability (Document ID 0364, pp.
4-5).
OSHA disagrees with NPGA's assertions. The agency notes that NPGA's
comments did not include any information to support their claim that
distinctions among flammable products are inconsequential to the
selection of handling procedures and safeguards. OSHA has good reason
to believe that the two categories previously provided for flammable
gases should be further refined, and in particular that splitting
flammable gas Category 1 into Category 1A and Category 1B will better
articulate the hazards of flammable gases to support appropriate hazard
communication, identification, and assessment of alternatives. Category
1 and Category 2 were based on the percentage of the gas in a mixture
with air that is ignitable and on ranges of flammability in air. In
practice, based on those criteria, almost all flammable gases (except
ammonia and methyl bromide, which are treated separately) are
classified as Category 1. Therefore, no distinctions were drawn between
gases that exhibit a wide spectrum of flammable properties for hazard
identification and communication purposes. The new subcategories of
flammable gases provide greater information on the exact conditions
under which the gas is flammable (i.e., flammability limit and its
fundamental burning velocity) and how flammable the gas is. Therefore,
under the proposed divisions downstream users will have the information
necessary to determine whether an alternative product would be not only
less flammable but also less likely to propagate, and thereby cause
less risk to workers (86 FR 9707).
Furthermore, NPGA's claim that OSHA exceeded the scope and purpose
of the HCS misstates OSHA's position. In the NPRM, OSHA noted that the
subdivision of Category 1 flammable gases would facilitate users
choosing a less flammable product where possible and gave an example
where a non-ozone depleting refrigerant was less flammable than propane
although they were both classified as Category 1. This example is
consistent with the purpose of the HCS to ensure that chemicals are
appropriately classified and information is transmitted to employers
and workers to enable better choices for worker safety and health, such
as choosing a chemical that is less flammable than an alternative. OSHA
was not suggesting in the NPRM that it would prefer to see the non-
ozone depleting chemical used because it would reduce ozone depletion,
but rather because of its lower flammability. Therefore, OSHA disagrees
with NPGA's objections and is finalizing the update to divide flammable
gases into Category 1A and 1B as proposed.
Heating, Air-conditioning, & Refrigeration Distributors
International (HARDI) asked OSHA to update its
Process Safety Management standard (PSM), 29 CFR 1910.119, to reflect
this change once this rule is finalized (Document ID 0355, p. 2).
HARDI's comment is out of scope for this rulemaking, which pertains
solely to updating the HCS. However, OSHA notes, as stated above, that
both subdivisions of Category 1 flammable gases (1A and 1B) remain
Category 1 flammable gases and therefore are covered by the PSM
Standard.
When OSHA revised the HCS in 2012, pyrophoric gases were not
classified under Rev. 3 (Document ID 0085). Therefore, to ensure that
the 2012 update did not reduce protections and that the hazards of
pyrophoric gases would continue to be covered and communicated
following the alignment with the GHS, OSHA specifically added
pyrophoric gases under the HCS. This involved addressing pyrophoric
gases under the definition of ``hazardous chemical'' and maintaining a
definition for ``pyrophoric gas'' in paragraph (c) of the HCS (77 FR
17704).
Since OSHA revised the HCS in 2012, the UNSCEGHS updated the
criteria for flammable gases to include pyrophoric gases (Document ID
0086; 0060, p. 53). Rev. 7 reflects the decision from the UNSCEGHS that
pyrophoric gases, as well as chemically unstable gases, should always
be classified as Category 1A flammable gases because pyrophoric gases
ignite spontaneously in air at temperatures of 54 [deg]C (130 [deg]F)
or below, and chemically unstable gases are able to react explosively
even in the absence of air or oxygen. In the NRPM, OSHA preliminarily
agreed with this decision and proposed incorporating it into Appendix
B.2.
OSHA also proposed to adjust the definitions in paragraph (c)
related to pyrophoric gases to reflect this change in Appendix B.2.
Further discussion of changes to the definition section can be found in
the Summary and Explanation for paragraph (c).
OSHA had previously defined pyrophoric gas in paragraph (c) as ``a
chemical in a gaseous state that will ignite spontaneously in air at a
temperature of 130 degrees F (54.4 degrees C) or below.'' The GHS
defines a pyrophoric gas as ``a flammable gas that is liable to ignite
spontaneously in air at a temperature of 54 [deg]C [130 [deg]F] or
below'' (Document ID 0065, p. 51). This change was officially made in
Rev. 8 of the GHS. OSHA proposed to align with the GHS use of the term
``liable to ignite'' to be more technically accurate, since some
pyrophoric gases may have a delayed ignition time (see, e.g., Document
ID 0065, p. 51, Note 4). OSHA also proposed to move the pyrophoric gas
definition to Appendix B.2. OSHA anticipated that these proposed
changes would have no significant impact on the scope of gases
considered pyrophoric gases, and did not expect that chemical
manufacturers or importers would need to reclassify chemicals due to
these changes.
As noted above, OSHA also proposed adding a new subcategory for
chemically unstable gases to the flammable gases hazard class to allow
for more accurate communication of the hazards associated with those
gases. OSHA proposed to adopt the Rev. 7 definition of a chemically
unstable gas: ``a flammable gas that is able to react explosively even
in the absence of air or oxygen'' (Document ID 0060, p. 53) in
paragraph B.2.1. Consistent with Rev. 7, under proposed Table B.2.1, a
Category 1A chemically unstable gas would be further sub-classified
into one of two categories based on the temperature and pressure at
which it becomes unstable. The proposed criteria for Category 1A/A
chemically unstable gases are ``flammable gases which are chemically
unstable at 20 [deg]C (68 [deg]F) and a standard pressure of 101.3 kPa
(14.7 psi).'' The proposed criteria for Category 1A/B chemically
unstable gases are ``flammable gases which are chemically unstable at a
temperature greater than 20 [deg]C (68 [deg]F) and/or a pressure
greater than 101.3 kPa (14.7 psi).''
As OSHA explained in the NPRM, a chemically unstable gas is a
subcategory of flammable gases, and any chemical that meets the
criteria for chemically unstable gas would have met the previous HCS
definition of flammable gas. While these hazards were classified in
flammable gases, the UNSCEGHS noted that these gases exhibit slightly
different behaviors, have the propensity to react dangerously even in
the absence of any reaction partner (e.g., air or oxygen), and should
have different hazard communication elements (Document ID 0250, p. 5).
Because chemical manufacturers are currently classifying chemically
unstable gases as flammable gases, OSHA did not propose a new hazard
category for these gases. Instead, OSHA proposed the addition of
chemically unstable gases as a separate category in the appendix for
flammable gases (Appendix B.2) to improve the way the hazards of these
gases are identified, evaluated, and communicated.
Rev. 7 (Document ID 0060, p. 53) also added three clarifying notes
under Table 2.2.1 that were not included in Rev. 3 (Document ID 0085).
The notes provide guidance on the classification of flammable gases
under the new hazard categories. OSHA proposed to add these notes to
the HCS following Table B.2.1 because they allow for better clarity and
communication of hazards. Proposed Note 2 states ``In the absence of
data allowing classification into Category 1B, a flammable gas that
meets the criteria for Category 1A shall be classified by default in
Category 1A.'' Proposed Note 3 states ``Spontaneous ignition for
pyrophoric gases is not always immediate, and there may be a delay.''
Proposed Note 4 states ``In the absence of data on its pyrophoricity, a
flammable gas mixture should be classified as a pyrophoric gas if it
contains more than 1% (by volume) of pyrophoric component(s).''
Rev. 7, in Chapter 2.2.4.2, provides additional guidance on the
classification of flammable gases, including the new hazard categories
(Document ID 0060, p. 57). It includes updated references to consensus
standards and test methods (i.e., ISO 10156:2017), and new references
to consensus standards and test methods related to the new hazard
categories (i.e., ISO 817:2014, IEC 60079-20-1 ed1.0 (2010-01), DIN
51794, and Part III of the UN Manual of Tests and Criteria). OSHA
proposed to adopt these changes, with edits to make the GHS criteria
mandatory (i.e., changing ``should'' to ``shall''), to add U.S. units
of measurement (e.g., Fahrenheit), and to incorporate by reference the
cited standards and test methods. To incorporate this guidance from the
GHS Chapter 2.2.4.2, OSHA proposed edits to the already-existing
paragraph B.2.3. (B.2.3.1, as proposed) and proposed similar language
in new paragraphs B.2.3.2, B.2.3.3 and B.2.3.4. However, OSHA did not
propose to require chemicals that were already classified using an
earlier version of ISO 10156 to be reevaluated with the updated test
method; the updated criteria would apply only to new chemicals or
chemicals not already classified.
The revisions to B.2.3.1 proposed to update the consensus standards
and testing methods that were previously referenced in that section.
Proposed B.2.3.2 included guidance on the test methods to determine
pyrophoricity. Proposed B.2.3.3 includes guidance regarding when
testing should be considered for pyrophoric gases and how to classify
flammable gas mixtures if testing has not been done. Proposed B.2.3.4
provides guidance on the test methods to determine chemical stability,
including references to the most up-to-date editions.
OSHA received a few comments on the additions of pyrophoric gases
and chemically unstable gases as
subcategories to the flammable gases hazard class. API indicated they
supported the proposed changes as they would align with the GHS
(Document ID 0316, pp. 21-22). Cal/OSHA submitted several comments on
OSHA's proposed changes in Appendix B.2. pertaining to Notes 3 and 4
below Table 2.1 and proposed paragraph B.2.3.3.
First, Cal/OSHA observed that Note 3 ``describes a uniquely
hazardous property of pyrophoric gases; that is, their potential delay
in ignition,'' which in their view demonstrates the necessity of clear
testing protocols and ``erring on the side of classification and
labelling to protect downstream users'' (Document ID 0322, Att. 2, p.
7). Cal/OSHA requested that OSHA revise proposed Note 3, which states
that spontaneous ignition is not always immediate, by removing ``and
there may be a delay'' from the first sentence, and adding in a second
sentence a discussion of the factors which influence the time it takes
for pyrophoric gases to spontaneously ignite and by stipulating that a
rigorous testing regime is required for all flammable gases that
contain pyrophoric components in any amount. Cal/OSHA's suggested text
also states that ``when experience or past practice indicates a higher
degree of hazard [than indicated by testing], the classification must
reflect that experience'' (Document ID 0322, Att. 2, pp. 7-8).
Second, Cal/OSHA submitted comments on OSHA's proposed paragraph
B.2.3.3 and argued that it ``gives undue discretion to producers at the
expense of workers and downstream users'' since it would allow
producers to avoid classifying and labeling a flammable gas as
pyrophoric ``when experience in production or handling shows that the
substance does not ignite spontaneously on coming into contact with air
at a temperature of 130 [deg]F (54 [deg]C) or below'' (Document ID
0322, Att. 1, p. 17). Finally, they asserted that the paragraph is
inconsistent with Note 3 since OSHA in one place is providing
manufacturers the discretion on when to test and in another place
indicating caution because there is variability and cases where the
pyrophoric effects may be delayed, which indicates pyrophoric gases are
``uniquely hazardous.'' Cal/OSHA commented that this introduces
``ambiguities and unclear regulatory direction with regard to
pyrophoric gases'' and suggested deleting paragraph B.2.3.3 in its
entirety (Document ID 0322, Att. 2, pp. 7-8).
Finally, Cal/OSHA requested that OSHA revise proposed Note 4, which
states that a flammable gas mixture should be classified as a
pyrophoric gas if data on its pyrophoricity is absent and it contains
more than 1% (by volume) of pyrophoric component(s). Cal/OSHA suggested
revising this note to state that ``All flammable gases that contain
0.01% or more of a pyrophoric gas must be subjected to testing for
pyrophoricity and classified accordingly.'' They also suggested
changing ``should'' to ``must'' and ``1%'' to ``0.01%'' in the existing
sentence. Finally, they suggested adding a sentence indicating that
``when experience or past practice indicates pyrophoricity with a
lesser percentage, the classification must reflect that experience''
(Document ID 0322, Att. 2, pp. 7-8).
OSHA disagrees with most of Cal/OSHA's suggested changes. First,
OSHA does not require testing under the HCS. This has been a long-
standing position (48 FR 53291, 53336). Therefore, it would not be
appropriate to add testing requirements or imply testing requirements
under this hazard class. This does not negate the fact that SDS and
label preparers must use all available data and relevant experience
when classifying chemicals. But to the extent that Cal/OSHA's suggested
revisions to Notes 3 and 4 would mandate testing in order to comply
with the HCS, they would be contrary to the approach taken in the HCS.
Therefore, OSHA is not adopting them.
OSHA also does not see B.2.3.3 and Note 3 as creating
inconsistencies or ambiguities in requirements for classification of
pyrophoric gases. B.2.3.3 provides the requirements for classification
and Note 3 provides some guidance on the potential properties of
pyrophoric gases that SDS and label preparers need to be aware of. OSHA
does not believe that either B.2.3.3 alone or these paragraphs in
combination give manufacturers undue discretion but rather accounts for
the inherent challenges of requiring classification without requiring
testing. B.2.3.3's statement that experience can be used to determine
whether to apply the classification procedures for pyrophoric gases
does not mean that experience can override test data; if there are
already test data available for these chemicals that indicate it is
pyrophoric, the test data would be used over ``experience'' or ``expert
judgement.'' B.2.3.3 also requires that the manufacturer classify the
chemical if it contains 1 percent or greater of a pyrophoric gas in the
absence of testing, which means the classifier only has discretion when
a mixture contains less than 1.0 percent pyrophoric gas. OSHA therefore
disagrees with Cal/OSHA's request to delete paragraph B.2.3.3. OSHA
also does not agree that 1% should be changed to 0.01% in Note 4. Cal/
OSHA did not supply any additional information or data supporting why
OSHA should deviate from the GHS text that was developed by the subject
matter experts at the GHS subcommittee. However, OSHA will consider
whether to include some of the discussion regarding variability of
spontaneous ignition that Cal/OSHA suggested for Note 3 as
recommendations when OSHA updates its classification guidance following
promulgation of this final rule.
OSHA agrees with Cal/OSHA that the wording in Note 4 should include
mandatory language instead of ``should.'' OSHA's original intent was to
update proposed GHS text where appropriate to make it mandatory,
including Note 4.
For the reasons discussed above, OSHA is finalizing all of section
B.2 as proposed, with the exception of changing ``should'' to the
mandatory language ``shall be'' in Note 4.
III. Aerosols and Chemicals Under Pressure (Appendix B.3)
OSHA proposed to align with Rev. 7 (Document ID 0060, pp. 59-62) by
expanding the existing Flammable Aerosols hazard class (Appendix B.3)
to include non-flammable aerosols as well as flammable aerosols. Under
Rev. 3 and the 2012 HCS, Chapter 2.3 and Appendix B.3, were each titled
``Flammable Aerosols.'' Under Rev. 3, the hazards presented by non-
flammable aerosols were either not classified at all or were classified
in another health hazard class or physical hazard class (e.g., gases
under pressure) (Document ID 0085).
As OSHA explained in the NPRM (86 FR 9708), the agency believes
that most aerosols are classified as gases under pressure under Rev. 3
(and were classified accordingly under the HCS) because of the design
criteria of the aerosols under DOT regulations (Document ID 0163).
Under DOT regulations, aerosols are ``any non-refillable receptacle
containing a gas compressed, liquefied, or dissolved under pressure''
and the highest permissible pressure is 180 psig at 130 [deg]F in most
cases (see 49 CFR 171.8, 173.306). Accordingly, under DOT regulations,
most aerosols meet the current HCS criteria for gases under pressure,
which are gases contained in a receptacle at a pressure of 200 kPa (29
psig) or more, or which are liquefied or liquefied and refrigerated
(see existing paragraph B.5.1). However, OSHA believes that classifying
aerosols as gases under pressure may not accurately identify the
hazards of aerosols because aerosol containers differ from
pressurized gas cylinders in terms of container characteristics and
failure mechanisms.
Since Rev. 3, the UNSCEGHS and the UNSCETDG agreed to rename
Chapter 2.3 ``Aerosols'' and to add a new non-flammable aerosol hazard
category, Category 3, to the aerosols hazard class (Document ID 0060,
pp. 59-60). This hazard category now captures aerosols that (1) contain
1% or less flammable components (by mass); and (2) have a heat of
combustion that is less than 20 kilojoules per gram (kJ/g).
As OSHA described in the NPRM, OSHA assessed the hazards associated
with aerosol containers and compressed gas cylinders to consider the
impacts of the proposed change and ensure that it would not compromise
worker safety and health. A study conducted for OSHA by ERG, an OSHA
contractor, evaluated how aerosol products and gases under pressure
differ in terms of container characteristics, failure mechanisms, and
previous incidents (Document ID 0009). The ERG report concluded that
sizes and pressures of compressed gas cylinders far exceed those of
hand-held containers typically used for aerosol products. The report
also noted differences in failure mechanisms for pressurized cylinders
versus aerosols, including that although non-flammable aerosol cans do
not present a significant fire hazard, they can present a hazard from
bursting resulting from thermal content expansion during heating
(Document ID 0009). This conclusion was also supported by data from
OSHA's Fatality and Catastrophe Information Summary (FatCat) database,
located at https://www.osha.gov/pls/imis/accidentsearch.html, which
revealed that employees are at greater risk of a fatality due to the
failure of the container if they are working with compressed gas
cylinders than they are if they are working with aerosol cans (86 FR
9709).
Following a review of the data and the ERG report, OSHA
preliminarily determined that a new category for non-flammable aerosols
is appropriate. Additionally, OSHA noted that this new classification
would ensure compressed gas pictograms are not included on aerosol
labels, eliminating the risk of ``over warning'' about the hazards of
aerosol containers (UN, 2010, Document ID 0095).
OSHA proposed several other changes related to changes in the GHS
including: updating the aerosol hazard class to include non-flammable
aerosols (Category 3 in Table B.3.1); changing the name of Appendix B.3
from ``Flammable Aerosols'' to ``Aerosols;'' replacing the phrase
``flammable aerosols'' with ``aerosols'' throughout Appendix B.3, as
appropriate; and adding clarifying information from Rev. 7 to paragraph
B.3.2 (now B.3.1.2) (Document ID 0060, p. 59). For example, OSHA
proposed to revise Note 2 to B.3.2.1 (now B.3.1.2.1) to explain that
aerosols do not fall within the scope of gases under pressure, but may
fall within the scope of other hazard classes. OSHA preliminarily
concluded that aerosols (flammable and non-flammable) should not also
be classified as gases under pressure in order to ensure that the
appropriate hazard warnings are presented on aerosol containers.
OSHA also proposed to adopt Rev. 7 (Document ID 0060) criteria for
a non-flammable aerosol (i.e., an aerosol that does not meet the
criteria for Category 1 or 2, contains less than or equal to 1 percent
flammable components (by mass), and has a heat of combustion less than
20 kJ/g)), and to add those criteria as new Category 3 in Table B.3.1.
This new category, Category 3, was proposed to update hazard
communication requirements to better reflect the true hazards of non-
flammable aerosols. As further discussed below in the Summary and
Explanation for Appendix C, OSHA reasoned that this would also result
in changing the labeling for any such aerosols that are currently
classified as compressed gases, including the pictogram and hazard
statements, and would better differentiate between the hazards
associated with compressed gases and the hazards associated with
aerosols.
OSHA received several comments on the proposed changes to the
aerosol hazard class. ACA, IHSC, and Seymour of Sycamore supported the
inclusion of non-flammable aerosols (Document ID 0368, p. 9; 0349, p.
2; 0321, p. 2). HCPA also expressed support, noting that ``Expanding
the current `Flammable Aerosols' hazard class to include all aerosol
products not only makes logical sense but aligns with both the GHS
Rev.7 and GHS Rev. 8'' (Document ID 0327, pp. 8-9). Michele Sullivan
commented that ``The proposed changes to the Flammable Aerosols/
Aerosols Chapter are particularly welcomed'' because they re-align the
HCS with the GHS. NIOSH agreed with OSHA that the addition of a new
hazard class and several new hazard categories to Appendix B would
improve worker safety through more specific descriptions of hazards
(Document ID 0281, Att. 2, p. 5; 0423 pp. 22-23). ACC commented in
support of changes to the aerosols category that more closely align
with the GHS (Document ID 0347, p. 6).
Two commenters recommended that OSHA make the compressed gas
cylinder pictogram optional (Document ID 0368, p. 9; 0321, p. 2).
Seymour of Sycamore suggested allowing the optional use of the
pressurized cylinder pictogram for both non-flammable and flammable
aerosols because ``[t]he use of the pressurized cylinder icon provides
information to the end user that the product is under pressure and the
end user needs to be aware of conditions that could make the product
unsafe if the product is exposed to those conditions'' (Document ID
0321, p. 2). ACA similarly asked OSHA to make the use of the
pressurized cylinder pictogram optional because aerosols are common in
both consumer products and the workplace, even though they also noted
``[i]n environments where workers have a more sophisticated
understanding of pictograms, the symbol could lead to some confusion as
to whether the product is a non-flammable aerosol or a gas under
pressure'' (Document ID 0368, pp. 9-10).
OSHA disagrees with these comments for several reasons. First, as
OSHA indicated in the NPRM, the main reason for revising the aerosol
chapter is to better differentiate the hazards of aerosols and
compressed gases. As discussed above and in the NPRM, allowing the
compressed gas cylinder to aerosols would lead to ``over warning'' on
aerosols and could also dilute the message for compressed gases. In
addition, allowing the optional use of compressed gas pictogram would
introduce inconsistency between labels of similar products, and may
confuse downstream users, which ACA noted even as it suggested allowing
the pictogram. OSHA also notes that the hazard statement for
nonflammable aerosols makes clear that the container is pressurized and
therefore believes the hazard noted by Seymore of Sycamore is already
accounted for appropriately. Therefore, OSHA will not allow the
optional use of the compressed gas pictogram for aerosol products.
However, aerosol cans that have already been released for shipment as
of the compliance date of this final rule for labelling updates do not
need to be relabeled and may bear the compressed gas pictogram.
Although OSHA proposed updates to the classification and labeling
of aerosols to align with Rev. 7, the agency also noted in the NPRM
that Rev. 8 contains several significant additional changes in the
aerosol chapter and requested comments on whether the agency should
adopt two specific changes that appear in Rev. 8.
First, Rev. 8 lists classification criteria for aerosols as text in
a table (see the GHS Table 2.3.1, Criteria for aerosols), similar to
other hazard chapters, rather than referring classifiers to the
decision logics (Document ID 0065, pp. 57-58). When OSHA revised the
HCS in 2012, the agency declined to adopt the GHS decision logics and
used its own text for classification of flammable aerosols in Appendix
B. In the NPRM, OSHA preliminarily determined that there are no
substantive differences between OSHA's current text and the text
represented in the new Rev. 8 table, although they contain slightly
different language.
Several commenters suggested that OSHA should adopt the updated
language in Rev. 8 instead of Rev. 7 (Document ID 0316, p. 22; 0347, p.
6; 0327, p. 9; 0309, p. 14). ACC indicated updating to the Rev. 8
criteria table would maximize harmonization, thereby reducing the
regulatory burden on their members (Document ID 0347, p. 6).
While HCPA supported aligning with Rev. 8, they asked OSHA to
change proposed Table B.3.1 by deleting ``Contains >1% flammable
components'' from the Category 2 criteria to align with the table in
Rev. 8. HCPA reasoned that the proposed version of Table B.3.1 could be
misinterpreted to mean that an aerosol product Category 3 cannot
contain one percent or more of flammable material by mass or have a
heat of combustion equal to or greater than 20 kJ/g, which would
conflict with the GHS's two different criteria for an aerosol product
to be classified as a Category 3 aerosol (Document ID 0327, pp. 9-10).
OSHA disagrees with HCPA's comment. The first step in the decisions
logics for aerosols in Rev. 7 and Rev. 8 clearly states that only if an
aerosol has both less than one percent flammable component and less
than 20 kJ/g can it directly go to category three. Only after it fails
the subsequent criteria for Category 1 and 2 can it also become a
Category 3 aerosol (Document ID 0060, pp. 60-62; 0065, p. 59). OSHA has
taken this into account by using the word ``and'' in Category 3 to
indicate that the additional criterion applies to an aerosol that has
either greater than one percent flammable components or >=20 kJ/g. The
proposed criterion for Category 3 was intended to encompass both
scenarios as described by HCPA. Additionally, OSHA disagrees that the
HCS table could be interpreted to mean that a Category 3 aerosol could
not have greater than one percent flammable components because the
language ``Contains >1% flammable components, or the heat of combustion
is >=20 kJ/g'' in Category 2 is linked to the other criteria with an
``and''. Therefore the correct interpretation is that a chemical that
does not meet all of the criteria of Category 2 is a Category 3
chemical, rather than that just having more than one percent flammable
components or a heat combustion greater than or equal to 20 kJ/g
indicates a chemical belongs in Category 2. Therefore, OSHA declines to
make the modifications requested by HCPA. However, to avoid any
potential confusion with the proposed layout, OSHA is making an
editorial change to Category 3 by placing a (1) before the phrase ``The
chemical does not meet the criteria for Categories 1 and 2'' and a (2)
before the phrase ``the chemical contains <1% flammable components (by
mass) and has a heat of combustion <20 kJ.g.''
NIOSH expressed concern that incorporating the Rev. 8 changes might
lower worker protections relative to the proposed paragraph B.3.1 in
the HCS (Document ID 0281, Att. 2, p. 5). They noted that Table 2.3.1
in Rev. 8 allows certain aerosols with a heat of combustion >=20 kJ/g
to be classified in Category 3, while the proposed paragraph B.3.1,
which aligns with Rev. 7, requires all aerosols with a heat of
combustion >=20 kJ/g to be classified in Category 1 or 2. Therefore,
NIOSH reasoned, adoption of Rev. 8 provisions in Table B.3.1 might
lower worker protections from aerosols which could be classified in
Category 3 under the Rev. 8, but not the Rev. 7, decision logic.
OSHA agrees with NIOSH that there appears to be to an inconsistency
between Category 2 and Category 3 as they are presented in Table 2.3.1
of Rev. 8. OSHA notes that the Table B.3.1 in the HCS is consistent
with the decision logics provided in paragraph 2.3.4.1 of Rev. 7
(Document ID 0060, p. 60) and paragraph 2.3.1.4 of Rev. 8 (Document ID
0065, p. 59).
To avoid confusion and to harmonize with trading partners, such as
Canada, which adopted Rev. 7, OSHA is finalizing changes to the
aerosols hazard class to align with Rev. 7, as proposed. OSHA will
review the criteria in Rev. 8 for aerosols at the UN subcommittee to
ensure that it accurately reflects the original decision logics.
The second update to the classification and labeling of aerosols in
Rev. 8 that OSHA requested comment on was the adoption of a new hazard
category, chemicals under pressure, within the aerosols class (Document
ID 0065, pp. 61-63). OSHA noted that these products function similarly
to aerosol dispensers covered under DOT (49 CFR 173.115) but are packed
in pressure receptacles (refillable and non-refillable) of up to 450
liters (86 FR 9693). Chemicals under pressure used for spray
applications present hazards similar to those presented by aerosol
dispensers. Therefore, the classification criteria and hazard
information for the Rev. 8 hazard category of chemicals under pressure
are the same as for aerosols. In the NPRM, OSHA recognized that
adopting this hazard classification would bring some chemicals under
the purview of the HCS that currently are not covered (e.g., certain
aerosols in refillable containers) (86 FR 9693).
OSHA requested comment on whether the agency should adopt the Rev.
8 hazard category and classification criteria for chemicals under
pressure in the aerosol chapter. The agency received several comments
supporting the addition of chemicals under pressure. Michele Sullivan
was also generally supportive and noted that ``[t]his new hazard
category can be helpful to some stakeholders'' but requested that OSHA
stay as close as possible to the GHS text (Document ID 0366, p. 2).
NIOSH supported the addition of chemicals under pressure since it would
improve worker safety and health by covering certain chemicals that
might not be otherwise captured under the HCS (Document ID 0281, Att.
2, p. 5). Ameren and ACC also supported the addition of chemicals under
pressure (Document ID 0309, p. 14; 0347, p. 6). HCPA supported the
addition of chemicals under pressure to the HCS, but as a separate
chapter from aerosols. They noted that there are differences between
aerosols and chemicals under pressure such as the difference in size
limitations. HCPA concluded that since aerosols and chemicals under
pressure are independent hazard classes, ``it would be logical for
chemicals under pressure to be its own chapter . . . and separate from
aerosols'' (Document ID 0327, p. 9).
OSHA does not agree with HCPA that chemicals under pressure should
be in its own chapter. The agency believes that adding these categories
to the current chapter B.3 to keep the aerosols and chemicals under
pressure hazard classifications in the same chapter is appropriate,
since they are often similar chemicals in different receptacles, but is
providing separate definitions, hazard criteria, and hazard
communication elements to ensure that the differences between these two
hazards are recognized. The agency expects that clearly separating the
two categories with different definitions, criteria, and communication
elements will avoid
creating any confusion related to its inclusion in chapter B.3.
Furthermore, including it in the aerosols chapter allows the HCS to
remain aligned with the GHS and its numbering system.
For the reasons discussed above, OSHA is adding chemicals under
pressure as a separate hazard classification in the HCS within the
aerosols chapter. In adopting the chemical under pressure hazard
classification, OSHA is following a similar structure to the GHS. OSHA
is renaming B.3 ``Aerosols and Chemicals Under Pressure'' and adding a
new B.3.2 ``Chemicals under pressure'', including B.3.2.1
``Definition'' and B.3.2.2 ``Classification criteria.'' OSHA is
renumbering B.3.2 ``Classification criteria (under Aerosols) to B.3.1.2
to maintain consistency with the GHS. In finalizing the chemicals under
pressure hazard classification, OSHA is including all three categories
as defined in Table 2.3.3 in Rev. 8 as well as the hazard communication
elements in Table 2.3.4 in Rev. 8 (Document ID 0065, p. 62) in Appendix
C.16. OSHA has also removed the word ``aerosol'' from B.3.3.2 to
maintain alignment with the updates from Rev. 8 and to indicate that
the formation calculation relates to both aerosols and chemicals under
pressure.
For the reasons discussed above, OSHA is finalizing Appendix B.3 as
Aerosols and Chemicals Under Pressure. In the aerosols section, the
agency is aligning with Rev. 7 by including non-flammable aerosols as a
category and making the necessary revisions associated with that
change. The agency is not adopting Table 2.3.1 from Rev. 8. The agency
is, however, adding chemicals under pressure to B.3 in alignment with
Rev. 8.
OSHA received one out of scope comment on Appendix B.3. Toby Threet
suggested that OSHA change the word ``aerosol,'' as used in the context
of physical hazards, to ``spray cans'' in order to better differentiate
between the meaning of aerosol in Appendix A and Appendix B (Document
ID 0279, pp. 6-8). OSHA did not propose any changes to the definition
or use of the term aerosol so this comment is out of scope; therefore,
the agency is not making the suggested change. Furthermore, the agency
does not believe that the inconsistency in how aerosol is used in
Appendix A and Appendix B is an issue in practice. Over the past 10
years, while OSHA has published many letters of interpretation
pertaining to requests for clarification of terms in the HCS, the usage
of the term aerosol has not been raised as an issue, nor has OSHA seen
issues pertaining to these definitions in classifications.
IV. Oxidizing Gases (Appendix B.4)
OSHA proposed to revise the note in B.4.1, and the text in B.4.3
``Additional classification considerations,'' to clarify that the
provisions are referring to the most recent version of the ISO 10156
standard. In the NPRM, OSHA explained that the proposed change would
provide more clarity on the definition and classification of oxidizing
gases and lead to more accurate classification and improved
communication and would also align with Rev. 7 (Document ID 0060, pp.
63-65). OSHA noted that it did not propose to require reclassification
of chemicals already classified using an earlier version of ISO 10156,
only that new chemicals or chemicals not already classified needed be
classified according to the new ISO standard. OSHA did not receive any
comments on this revision and is finalizing it as proposed.
V. Gases Under Pressure (Appendix B.5)
OSHA proposed to align the definition of gases under pressure in
B.5.1 with Rev. 7 (Document ID 0060, p. 67) by adding a temperature of
20 degrees Celsius (68 degrees Fahrenheit) so that the full definition
reads ``gases which are contained in a receptacle at a pressure of 200
kPa (29 psi) (gauge) or more at 20 [deg]C (68 [deg]F), or which are
liquefied or liquefied and refrigerated.'' The proposed change was
intended to clarify that the pressure of the receptacle is measured at
standard conditions. OSHA also proposed to align with Rev. 7 by adding
a note to Table B.5.1 to clarify that aerosols should not be classified
as gases under pressure (Document ID 0060, p. 67). The proposed change
was a consequence of OSHA's proposal to add a new hazard category for
non-flammable aerosols, as discussed previously. OSHA received one
comment from HCPA indicating that they supported the proposed note
under Table B.5.1 (Document ID 0327, p. 9). OSHA is therefore
finalizing these changes as proposed.
VI. Flammable Liquids (Appendix B.6)
OSHA proposed to make several clarifying changes to the flammable
liquid hazard class in Appendix B.6. First, OSHA proposed to add a
reference to paragraph (a)(14) of the Flammable Liquids standard (29
CFR 1910.106), in paragraph B.6.3 in order to provide additional
guidance about methods that can be used to determine flash point for
storage purposes. Second, after updating the HCS in 2012, OSHA realized
there may be a concern with ensuring that information needed to
determine the appropriate storage for flammable liquids is adequately
documented on the SDS. Per 29 CFR 1910.106(a)(5), when an accurate
boiling point is unavailable, or for mixtures which do not have a
constant boiling point, the boiling point may be based on the 10% point
of a distillation performed in accordance with the Standard Method of
Test for Distillation of Petroleum Products, ASTM D-86-62. Together
with an appropriately measured flash point, this boiling point can be
used to categorize the mixture for use with Table H-12 in Sec.
[thinsp]1910.106 to determine the maximum allowable container size and
type. Use of a boiling point reported in Section 9 of an SDS (physical
properties), which is based on the ``first drop'' (or initial)
distillation temperature in D-86, will likely be conservative, but may
lead to more restrictive storage requirements than would be the case
using the 10% distillation point (see Appendix D, section 9(f)). OSHA
therefore proposed to add a clarifying footnote to B.6.3 explaining
that to determine the appropriate container size and container type for
a flammable liquid, the boiling point must be determined by the methods
specified under OSHA's Flammable Liquids standard (29 CFR
1910.106(a)(5)) and listed on the SDS.\58\ In addition, the proposed
note would explain that if the chemical manufacturer, importer, or
distributor used an alternative calculation (namely, the 10%
distillation point method) to find the boiling point to determine the
appropriate storage for flammable liquids, this must be clearly noted
on the SDS (in sections 7 and 9) to alert downstream users. In the
NPRM, OSHA explained that the agency did not intend for the updated HCS
classification requirements for flammable liquids to impact the
longstanding storage requirements under 29 CFR 1910.106. Manufacturers
can still use the flexibilities under Sec. 1910.106 for mixtures which
do not have a constant boiling point when determining storage
requirements. The proposed note was intended to ensure that the proper
container size and type will be used for storing flammable liquids
while still
appropriately communicating all necessary information on the SDS. OSHA
did not propose any changes to the classification criteria for
flammable liquids under the HCS. OSHA also requested comments on
whether a footnote like the one proposed for B.6.3 should be inserted
in Appendix D, Section 9.
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\58\ The flammable liquids standard states ``Boiling point shall
mean the boiling point of a liquid at a pressure of 14.7 pounds per
square inch absolute (p.s.i.a.) (760mm). Where an accurate boiling
point is unavailable for the material in question, or for mixtures
which do not have a constant boiling point, for purposes of this
section the 10 percent point of a distillation performed in
accordance with the Standard Method of Test for Distillation of
Petroleum Products, ASTM D-86-62 . . . may be used as the boiling
point of the liquid.'' 29 CFR 1910.106(a)(5).
---------------------------------------------------------------------------
Finally, OSHA realized that a note regarding cross-classification
of aerosols was inadvertently omitted from Appendix B.6. In the 2012
HCS, Appendix B.3 (formerly flammable aerosols) includes note 2 to the
classification criteria, which previously indicated that ``[f]lammable
aerosols do not fall additionally within the scope of flammable gases,
flammable liquids, or flammable solids.'' The HCS contains a cross-
referencing note in Appendix B.2 (flammable gases), but OSHA
inadvertently omitted the statement in Appendix B.6. OSHA therefore
proposed to add a note stating that aerosols should not be classified
as flammable liquids following Table B.6.1, for consistency and to
minimize confusion, in alignment with Rev. 7 (Document ID 0060, p. 71).
Several commenters expressed concerns about OSHA's proposed
addition of footnote 9 to Appendix B.6 (Document ID 0339, p. 3; 0316,
p. 23; 0359, p. 5; 0347, p. 23). API indicated that they were concerned
about this change not aligning with GHS (Document ID 0316, p. 23). DGAC
stated that they did not support limiting the determination of the
initial boiling point to just two ASTM standards because they believe
it is not necessary to list how to determine it and they were concerned
that OSHA was excluding the methods for determining initial boiling
point in the HMR (Document ID 0339, p. 3). Similarly, IHSC commented
that they did not support the addition to require the initial boiling
point to be determined by methods in Sec. 1910.106 and suggested that
OSHA limit this requirement for mixtures that contain an ingredient
(greater than 1 percent) with a boiling point less than 95 [deg]F
(Document ID 0349, p. 2). Dow commented that they disagreed with the
proposal to determine the initial boiling point by methods in Sec.
1910.106 because they believed this was a change to OSHA's position
that it does not require testing (Document ID 0359, p. 5). ACC
commented on the second half of the footnote specifically, requesting
that OSHA remove the requirement to note an alternate calculation in
Sections 7 and 9 of the SDS and asking why this was included as a
proposal in the update (Document ID 0347, p. 23).
OSHA believes that several of these commenters may have
misunderstood OSHA's proposed changes. Contrary to DGAC, IHSC, and
Dow's assertion, OSHA did not intend to suggest that the boiling point
could only be determined by the methods specified under OSHA's
Flammable Liquids standard. First, 29 CFR 1910.106(a)(5) does not
specify the means of determining the initial boiling point except
``Where an accurate boiling point is unavailable for the material in
question, or for mixtures which do not have a constant boiling point,''
so footnote 9 only addresses the calculation of boiling point when it
is being used to determine a storage container and type and where the
conditions in the flammable liquids standard are met. Second, while the
language of footnote 9 is mandatory (``shall be determined by methods
specified under Sec. 1910.106(a)(5)''), the language in paragraph
(a)(5) of the flammable liquids standard is permissive (``may be used
as the boiling point of the liquid''). When read together it is clear
that manufacturers, importers, and distributors can use other methods
approved by the HCS to determine boiling point and the flammable
liquids standard only adds another option for calculating boiling point
under specified conditions. This was intended to ensure that the HCS is
compatible with Sec. 1910.106 and to clarify situations where using
the initial boiling point for HCS classification would result in
storage requirements that might differ from the requirements under
Sec. 1910.106.
This alternate calculation is solely allowed in determining the
storage requirements for flammable liquids where an accurate boiling
point is not available and practically speaking would only apply to
Category 1 flammable liquid mixtures. For example, if a Category 1
flammable liquid had an initial boiling point of 80 [deg]F under the
methods in the HCS, but using the 10 percent point of distillation
accommodation for mixtures under Sec. 1910.106(a)(5) resulted in a
boiling point of 100 [deg]F, then for storage purposes under Sec.
1910.106 it would be considered a Category 2 flammable liquid. The new
footnote makes explicit that this second calculation is allowed to be
used for determining storage requirements under the HCS, but the SDS
preparer would need to add in Sections 7 and 9 of the SDS a note
stating that an alternate calculation was used for determining storage
requirements. For the example given above, an appropriate note would be
``Initial boiling point 80 [deg]F/estimated boiling point 100 [deg]F
(for storage purposes).'' However, if a category 1 flammable liquid
mixture had an initial boiling point of 80 [deg]F under the HCS methods
and the boiling point using the accommodation for mixtures under Sec.
1910.106(a)(5) was 92 [deg]F, then for storage purposes the flammable
liquid mixture would still be a Category 1 flammable liquid and there
would be no obligation to put in the additional note on the SDS. OSHA
believes this clarification addresses the concerns raised by these
commenters. However, to the extent that DGAC was commenting on the
sentence ``The initial boiling point shall be determined in accordance
with ASTM D86-07a or ASTM D1078,'' OSHA did not propose any changes to
that section and has previously also limited the calculation of boiling
point to these two ASTM standards, so that comment would be out of
scope.
Additionally, nothing in the proposal should be read to require
testing as Dow asserted. As with all of the references to testing
standards in the HCS, OSHA is only stating what methods are acceptable
for determining certain characteristics, not requiring the SDS or label
preparer to do these kinds of testing themselves. As to ACC's question
regarding why the calculation of initial boiling point should be
included in Sections 7 and 9 of the SDS if an alternate calculation was
used for storage purposes, OSHA proposed including that requirement to
ensure clarity on what underlying information about the chemical was
used so that users are able to apply that information accurately to
their own workplace and ensure worker safety. OSHA therefore disagrees
with ACC that this requirement should be removed. Finally, OSHA
disagrees with API's assertion that this footnote is problematic
because it is not aligned with the GHS. The alternate calculation is
not used in the ultimate classification of flammable liquids under the
HCS, therefore the HCS is in full alignment with the GHS. The addition
of the footnote is supplemental information (as allowed by the GHS)
and, as stated above, OSHA is including this requirement to ensure
clarity about the underlying information.
Even so, these comments indicate that the proposed language may be
confusing, so although OSHA is finalizing the proposed changes to B.6
(Flammable Liquids), the agency has updated the footnote for clarity.
As finalized, Footnote 9 to Appendix B.6 reads: ``To determine the
appropriate flammable liquid storage container size and type, the
boiling point shall be
determined by Sec. 1910.106(a)(5). In addition, the manufacturer,
importer, and distributor shall clearly note in Sections 7 and 9 of the
SDS if an alternate calculation was used for storage purposes and the
classification for storage differs from the classification listed in
Section 2 of the SDS.'' (Emphasis added to new text.)
OSHA received comments from ACA and Hach asking OSHA to add Note 2
from beneath Table 2.6.1 of Rev. 7 to the HCS (Document ID 0323, pp.
11-13; 0368, p. 12). That note states that liquids with a flash point
of more than 35 [deg]C and not more than 60 [deg]C need not be
classified as non-flammable liquids for some regulatory purposes, such
as transport, if negative results have been obtained in the sustained
combustibility test according to the sustained combustibility test L.2
of Part III, section 32 of the UNTDG, Manual of Tests and Criteria
(Document ID 0060, p. 71). Hach commented that adding this note to the
HCS would relieve compliance burdens and customer confusion regarding
the classification of certain liquids and suggested a slightly altered
version of the note in order to align with DOT PHMSA's regulation under
49 CFR 173.120 (Document ID 0323, pp. 11-13). Hach's comment is out of
scope for this rulemaking since the agency did not propose any changes
relating to this aspect of liquids classification. Furthermore, this
note was also part of Rev. 3 and OSHA opted not to incorporate Note 2
when promulgating the HCS in 2012 because it would reduce protections
in workplaces, where conditions may vary highly when handling chemicals
(e.g., heating chemicals above their flashpoint) (77 FR 17722).
VII. Flammable Solids (Appendix B.7)
OSHA proposed one change to Appendix B.7 (Flammable Solids): a new
Note 2 following Table B.7.1 stating that aerosols should not be
classified as flammable solids. As with flammable liquids, the UNSCEGHS
observed this omission in the flammable solids chapter, and Rev. 7
includes this note (Document ID 0060, p. 75). OSHA did not receive any
comments relating specifically to the addition of the new note and is
finalizing it as proposed.
OSHA received one comment pertaining to Appendix B.7. Toby Threet
asserted that OSHA should not promulgate provisions for flammable
solids until the agency has definitive criteria for ``fire by
friction'' (Document ID 0279, pp. 18-20). OSHA notes that this hazard
class was first promulgated in 2012 and OSHA did not propose to update
the criteria for flammable solids. Therefore, Threet's comment is
outside the scope of this rulemaking.
VIII. Self-Heating Chemicals (Appendix B.11)
OSHA proposed adding a note beneath Table B.11.1 to explain that
classification of solid chemicals must be based on tests performed on
the chemicals as presented. The note also provides an example
indicating that if a chemical is presented for supply or transport in a
physical form different from that which was tested and which is
considered likely to materially alter its performance in a
classification test, classification must be based on testing of the
chemical in the new form. Although this note was included in Rev. 3
(Document ID 0085, Att. 2, p. 84), and incorporated into Appendices
B.1, B.7, B.10, B.12 and B.14 in the HCS in 2012, it was inadvertently
omitted from Appendix B.11. OSHA proposed to add the note to be
consistent with the GHS and the way the HCS treats other physical
hazards. OSHA did not receive any comments on the new note and is
finalizing it as proposed.
IX. Chemicals Which, in Contact With Water, Emit Flammable Gases
(Appendix B.12)
OSHA proposed to update the classification criteria for Category 3
of this hazard class in Table B.12.1. In Rev. 3 (Document ID 0085, Att.
2, p. 87) and in the 2012 HCS, one of the criteria for a Category 3
classification is that the maximum rate of evolution of the flammable
gas is equal to or greater than 1 liter per kilogram of chemical per
hour. OSHA explained in the NPRM that this criterion does not
accurately reflect the corresponding criteria in Test N.5 in Part III,
sub-section 33.5.4.4.1 of the UN Manual of Tests and Criteria, which
provides that the maximum rate of evolution of the flammable gas is
greater than 1 liter per kilogram of chemical per hour (Document ID
0151, p. 379). OSHA proposed to delete the words ``equal to or'' in the
Category 3 criteria in Table B.12.1 to make the classification criteria
consistent with the criteria in the test methods, aligning with Rev. 7
(Document ID 0060, p. 91). OSHA preliminarily determined this proposed
change would not affect worker protections. OSHA did not receive any
comments on this change and is finalizing it as proposed.
X. Oxidizing Solids (Appendix B.14)
OSHA proposed to add a second set of classification criteria to
B.14.2 and to Table B.14.1 based on a new UN test method. Under Rev. 3
(Document ID 0085, Att. 2, p. 95), classification of oxidizing solids
was based only on Test O.1 from Part III, sub-section 34.4.1 of the UN
Manual of Tests and Criteria (Document ID 0151, p. 382). This was
reflected in the 2012 HCS, Appendix B.14. In the NPRM, OSHA explained
that the test material used as the reference mixture in Test O.1 has
been noted to pose a cancer hazard and is difficult to purchase.
Therefore, a new test, Test O.3 (Gravimetric tests for oxidizing
solids), which uses a reference mixture of calcium peroxide, has been
added to Part III, sub-section 34.4.3 of the UN Manual of Tests and
Criteria and the Recommendations on the Transport of Dangerous Goods
Model Regulations (TDG MR) (Document ID 0151, p. 393; 0150, p. 100).
Consistent with Rev. 7 (Document ID 0060, p. 97), OSHA proposed to
allow oxidizing solids to be classified using either Test O.1 or Test
O.3. The agency further noted that since the proposed classification
criteria would allow the use of data from either Test O.1 or O.3, data
from existing classifications could be used and no new testing would be
required for substances or mixtures that were previously classified
based on Test O.1.
OSHA also proposed to update Note 1 to Table B.14.1 to reflect a
2017 revision to the International Maritime Solid Bulk Cargoes Code for
testing of explosion hazards (Document ID 0141). OSHA did not receive
any comments on the addition of Test O.3 or on the update to this note
and is therefore finalizing both as proposed (with a technical
amendment to reorganize B.14.2 to better clarify which version of the
Manual of Tests and Criteria is appropriate for Test O.1 and Test O.3).
OSHA received one comment on Appendix B.14 from Cal/OSHA opposing
the language in B.14.3.3, which requires that, in the event of a
difference between test results and known experience in the handling
and use of chemicals which shows them to be oxidizing, judgements based
on known experience take precedence over test results. Cal/OSHA
suggested revising B.14.3.3 to state that ``experience demonstrating an
oxidizing hazard shall take precedence over negative test results''
(Document ID 0322, Att. 1, pp. 12-13). OSHA did not propose any changes
to B.14.3.3 in the NPRM, therefore this comment is outside the scope of
this rulemaking. OSHA notes that Cal/OSHA's suggested language, while
structured differently than B.14.3.3, presents the same requirement:
producers must disclose oxidizing hazards for a chemical if the
producer has experience that indicates those hazards, even if test
results for the chemical are negative. Further
discussion on the use of expert judgement in the classification process
can be found in the Summary and Explanation for Section B.2 (flammable
gases).
XI. Corrosive to Metals (Appendix B.16)
OSHA did not propose to make any changes to Appendix B.16,
Corrosive to Metals. This is notable because OSHA preliminarily decided
not to adopt a note that was added in Chapter 2.16 of Rev. 7, under
Table 2.16.2, which states: ``Where a substance or mixture is
classified as corrosive to metals but not corrosive to skin and/or
eyes, some competent authorities may allow the labelling provisions
described in 1.4.10.5.5'' (Document ID 0060, p. 107). Chapter
1.4.10.5.5 contains, in relevant part, labeling provisions that state
competent authorities can allow the corrosive to metals pictogram to be
omitted from labels for ``substances or mixtures which are in the
finished state as packaged for consumer use'' (Document ID 0060, p.
32). As was discussed in the NPRM, OSHA preliminarily concluded that
the note in question, and the labeling provisions it refers to, are not
applicable to the HCS because the HCS applies only to use of chemicals
in the workplace, and not to consumer products (29 CFR 1910.1200
(b)(5)(v)) and therefore OSHA did not propose to adopt the note. OSHA
did not receive any comments on this preliminary conclusion and is
therefore finalizing its decision not to add the note to Appendix B.16.
OSHA received one out of scope comment on this hazard class. Toby
Threet commented that OSHA should add copper to Table 16.1 (Document ID
0279, p. 22). OSHA notes that since the agency did not propose adding
copper to Table 16.1 or otherwise changing it, this comment is outside
the scope of this rulemaking.
XII. Desensitized Explosives (Appendix B.17)
OSHA proposed to add a new physical hazard class for desensitized
explosives to align with Rev. 7 (Document ID 0060, p. 109).
Desensitized explosives are chemicals that are treated so that they are
stabilized, or their explosive properties are reduced or suppressed. As
OSHA discussed in the NPRM, these types of chemicals can pose a hazard
in the workplace when the stabilizer is removed, either as part of the
normal work process or during storage of the chemical. Therefore, it is
important that the hazards be identified and appropriately
communicated.
In the 2012 HCS, OSHA acknowledged, consistent with Rev. 3
(Document ID 0085, Att. 6, p. 15), that these chemicals are considered
explosives if the wetting agent is removed by including in Appendix C,
C.4.14, the precautionary statement ``Keep wetted with'' and
instructing the chemical manufacturer, importer, or distributor to
specify appropriate material for wetting if drying out increases the
explosion hazard. However, the hazard statement, signal word, pictogram
and other precautionary statements required under the 2012 HCS C.4.14
primarily target more conventional explosives. This gap in
communication was recognized as early as 2005, when the UNSCEGHS noted
that desensitized explosives may become explosive under certain
circumstances--especially after long-term storage and during handling
and use (Document ID 0206). In 2014, the UNSCEGHS concluded that a new
hazard class was warranted for desensitized explosives in the GHS
(Document ID 0087). Rev. 7 separately classified desensitized
explosives with a full set of unique label elements (including the
appropriate signal word, hazard statement, pictogram, and precautionary
statements) (Document ID 0060, pp. 109-112). Desensitized explosives
are labeled with a flame pictogram rather than the explosive bomb used
for explosives, and the precautionary statements are tailored to the
specific traits of desensitized explosives.
As discussed in the NPRM, OSHA reviewed the UNSCEGHS reports on
desensitized explosives and preliminarily concluded that the hazard
class should also be added to the HCS to improve communication about
these hazards. While the chemicals captured by the desensitized
explosives hazard class were covered under the scope of the 2012 HCS as
explosives, OSHA preliminarily determined that adding the proposed new
hazard class to the HCS would ensure downstream users receive more
accurate hazard information on labels and in SDSs for these chemicals.
For these reasons, and to align with the GHS, OSHA proposed to add
the desensitized explosives hazard class to the HCS as Appendix B.17.
As explained in the NPRM, OSHA intended the new Appendix B.17 to
provide relevant definitions and general considerations, specify
applicable classification criteria, and include information about
additional classification considerations for this hazard class, as well
as reference several sections from the UN Manual of Tests and Criteria
that would be incorporated by reference. As with all hazard classes,
Rev. 7 does not require testing and allows classifiers to use data
reported in the literature that was generated using specified or
equivalent test methods. Proposed Appendix C.4.30 included the proposed
communication elements for desensitized explosives relevant to proposed
Appendix B.17.
The proposed Appendix B.17 was based on Chapter 2.17 of Rev. 7
(Document ID 0060, p. 109-112). OSHA proposed to adopt most of the
classification language on desensitized explosives from Chapter 2.17 to
minimize deviations from the GHS. However, similar to the 2012
rulemaking, OSHA carefully reviewed each of the hazard classification
criteria within the context of the HCS and proposed to modify some of
the language. These edits included changing some recommendations in the
GHS to mandatory requirements in the HCS (i.e., changing ``should'' to
``shall''); revising some terms in the GHS to more accurately reflect
terminology in the HCS (e.g., changing ``manufacturer/supplier'' to
``manufacturers, importers, and distributors''); revising text to make
it clear that data for classification can be obtained from the
literature; and removing references to classifications for
transportation that do not apply under the HCS. OSHA also proposed
adding a definition for ``phlegmatized,'' which is drawn from the TDG
MR, in a footnote because many stakeholders may be unfamiliar with that
term from the UN Recommendations.
OSHA did not propose to include portions of Chapter 2.17 that do
not relate specifically to the method of classification for
desensitized explosives, such as the text relating to hazard
communication (which is in Appendix C) and the decision logics. OSHA
may, however, use the decision logics in guidance materials.
OSHA received several comments on the proposed addition of Appendix
B.17, all of which supported adopting the desensitized explosive hazard
class. ACC, API, Michele Sullivan, and Dow expressed support for
aligning the classification of desensitized explosives with the GHS and
trading partners (Document ID 0347, p. 17; 0316, p. 23; 0366, p. 7;
0359, p. 5). API commented that ``[d]esensitized explosives should be
classified in accordance with GHS'' (Document ID 0316, p. 23). Other
than ensuring that the language is appropriate for OSHA's jurisdiction
and written in regulatory language, OSHA's proposal follows the GHS
classification criteria. For the reasons explained above, OSHA is
finalizing Appendix
B.17 as proposed with minor editorial changes. Stakeholders can examine
the redline strikeout of the regulatory text (changes from 2012 HCS to
this final) at OSHA's HCS web page (https://www.osha.gov/dsg/hazcom/)
to view all of the changes to the 2012 HCS made in this final rule.
Additionally, in the NPRM OSHA requested comments on whether the agency
should, in the final rule, update all of the existing references to UN
ST/SG/AC.10 (many of which are in Appendix B) to Rev. 6 or add Rev. 6
references to the existing Rev. 4 references such that they would be
alternative options for compliance. OSHA only received one comment on
this, which was from Ameren, and which supported adding the Rev. 6
references to allow for compliance alternatives (Document ID 0309, p.
14).
As discussed in the Summary and Explanation for Incorporation by
Reference, OSHA has decided to retain the generic citation to ST/SG/
AC.10 in all places where compliance with Rev. 4 or Rev. 6 is allowed,
and has inserted specific citations to ST/SG/AC.10/11/Rev.6 where only
Rev. 6 is allowed for compliance (for instance, in situations where new
text was added to Rev. 6 and there was no comparable material in Rev.
4). For further discussion of that issue, see the Summary and
Explanation for Incorporation by Reference.
OSHA also received one general comment on Appendix B from Cal/OSHA,
noting that ``In several places, referenced technical documents are
out-of-date'' and recommending that the most recent versions of
document should be used ``unless there is a specific reason not to,
such as where an updated test method is less sensitive than the
previous method, for example'' (Document ID 0322, Att. 2, p. 14). Cal/
OSHA did not provide further details on which references to technical
documents it believed were out of date. OSHA is updating several
references to technical documents in this rulemaking, which are
discussed throughout the Summary and Explanation, and it concludes that
it has updated all of the appropriate references.
E. Appendix C
Appendix C includes requirements and instructions for the
allocation of label elements. Paragraph (f)(2) requires the chemical
manufacturer, importer, or distributor to ensure that the information
provided on the label is in accordance with Appendix C. Appendix C
provides hazard statements, signal words, pictograms, and precautionary
statements for all four essential aspects of hazardous chemical
management (prevention, response, storage, and disposal), as well as
general labeling instructions.
OSHA proposed several updates to Appendix C to improve
communication of hazard information on labels. These changes were
proposed in order to: (1) address labeling requirements for the new
hazard classes and categories in Appendix B (physical hazards); (2)
align the HCS with Rev. 7; and (3) improve alignment of the HCS with
other federal agencies and Health Canada's labeling requirements in
furtherance of the goals of the RCC.
As was discussed in OSHA's 2009 proposal to align the HCS with the
GHS, the precautionary statements, unlike the hazard statements, were
not harmonized (but were merely codified) under the GHS, meaning that
numbers were assigned to them. This meant that the statements were not
yet considered to be part of the harmonized text (like hazard
statements); rather they were included in the GHS as suggested language
(74 FR 50282-83). OSHA chose to add these statements in the final HCS
rule in 2012 (77 FR 17574). However, since the promulgation of the
updates to the HCS in 2012, the UNSCEGHS has continued work to improve
the utility of precautionary statements by providing better guidance on
the allocation of statements, updating the statements to provide better
protection, and adding new statements for new hazard classes and
categories. In the 2021 NPRM, OSHA proposed several changes based on
new precautionary statements and instructions in Rev. 7. Additionally,
since 2012, OSHA has continued to work with other Federal agencies on
crosscutting labeling issues. Some updates to Appendix C were proposed
to align with DOT labeling regulations. OSHA also proposed updates to
Appendix C based on the agency's cooperation with Health Canada under
the RCC. The RCC was reaffirmed through a memorandum of understanding
signed in June 2018 (Document ID 0217), with the expectation of
aligning efforts for international trade requirements between the two
countries.
Overall, OSHA anticipated that the proposed changes to Appendix C
would provide improved communication of hazard information and greater
detail and clarity for downstream users, which would maintain or
enhance the safety and health of workers. The agency also expected the
updates would more consistently align the HCS with other Federal and
international regulations, thereby easing compliance burdens for U.S.
stakeholders that must also comply with those requirements.
The changes OSHA proposed to Appendix C and the changes OSHA is now
finalizing are extensive. OSHA addresses the substantive changes in the
discussion below, and in addition to the regulatory text below, OSHA
will provide a redline strike-out version of the final text of Appendix
C on the OSHA website (https://www.osha.gov/dsg/hazcom/), as it did for
the NPRM. This version will reflect all of OSHA's revisions, including
all non-substantive updates. This will allow interested parties to view
all of the changes in context to aid in the implementation of the
updated regulatory text. OSHA encourages stakeholders to use that
document in conjunction with the discussion of the revisions below, as
the discussion does not fully describe all of the non-substantive or
editorial changes OSHA is making.
I. Sections C.1-C.3
The instructions in the beginning of Appendix C (C.1-C.3) provide
directions and information about the signal words, pictograms, hazard
statements and precautionary statements required in C.4. OSHA proposed
several changes to C.1-C.3.
First, OSHA proposed to revise Figure C.1, Hazard Symbols and
Classes, to include ``HNOC (non-mandatory)'' as a hazard identified by
the exclamation point pictogram. This proposed change would codify
OSHA's agreement with Health Canada to permit the exclamation mark
pictogram to be used for HNOCs. While OSHA does not require labeling
for HNOC hazards, Health Canada requires a pictogram, signal word,
hazard statements, and precautionary statements for HNOCs. To ensure
that U.S. and Canadian requirements can simultaneously be met for
HNOCs, OSHA and Health Canada have provided guidance allowing an
exclamation mark pictogram to be used for HNOCs (Document ID 0103). Use
of the exclamation mark pictogram would not be mandatory under the HCS.
OSHA also added desensitized explosives under the flame pictogram in
Figure C.1, and that change is discussed with the other changes related
to desensitized explosives below (see discussion of revisions to C.4).
OSHA proposed several additional related changes. As discussed
above under the Summary and Explanation for paragraph (f), OSHA
proposed to move the existing text in paragraph C.2.3.3 from Appendix C
to paragraph (f)(5)(iii) in the text of the standard, so that all of
the instructions related to the transport of hazardous chemicals and
DOT regulations are in one section of the HCS. OSHA also proposed to
replace
that text in C.2.3.3 with a new paragraph, which would allow the
exclamation mark pictogram to be used for HNOCs if the words ``Hazard
Not Otherwise Classified'' or the letters ``HNOC'' appear below the
pictogram on the label. Additionally, because any pictogram may appear
only once on a label, OSHA proposed to add a new paragraph at C.2.3.4
to specify that if multiple hazards require use of the same pictogram,
it may not appear a second time on the label. This includes situations
when the exclamation mark pictogram would be used for both an HNOC and
for another hazard. OSHA requested comments on these proposed changes,
particularly whether the agency should require the exclamation mark
pictogram to be used for HNOCs.
OSHA received several comments supporting the proposal to include
``HNOC (non-mandatory)'' as a hazard identified by the exclamation
point pictogram (Document ID 0349, p. 2; 0309, p. 17) and agreeing that
use of the pictogram for HNOCs should not be mandatory (Document ID
0316, p. 25; 0347, p. 18; 0366, p. 7). OSHA received no comments
objecting to these revisions to Figure C.1, C.2.3.3, and C.2.3.4 and is
therefore finalizing them as proposed.
The remaining changes OSHA proposed for C.2 reflect updates to the
GHS that are intended to provide additional flexibility to the label
preparer while still communicating the required information. OSHA
proposed to add new paragraph C.2.4.7 to note that precautionary
statements may contain minor textual variations from the text
prescribed elsewhere in Appendix C (e.g., spelling variations,
synonyms, or other equivalent terms), as long as those variations
assist in the communication of safety information without diluting or
compromising the safety advice. This proposed new paragraph also
required that any variations must be used consistently throughout the
label and SDS. Because of the proposed addition of new paragraph
C.2.4.7, OSHA also proposed to renumber existing paragraphs C.2.4.7 and
C.2.4.8 to become C.2.4.8 and C.2.4.9, respectively.
ACC and Michele Sullivan generally supported the addition of
proposed paragraph C.2.4.7 because it adds flexibility (Document ID
0347, p. 18; 0366, p. 8). ACC, however, requested that OSHA remove the
proposed requirement to use any variations in precautionary statements
consistently on the label and SDS. According to ACC, most companies use
SDS software that comes with the GHS precautionary phrases from the
regulation already pre-loaded and ready for use; therefore, in their
view, modifying the phrases in the SDS software in small ways to
exactly match the text on the label would create a significant burden
without enhancing worker protection (Document ID 0347, pp. 18-19).
Michele Sullivan similarly stated that making small changes to
precautionary statements that do not change their meaning requires
significant time and money without improving worker protection or
safety (Document ID 0366, p. 8).
OSHA disagrees with ACC's request. New paragraph C.2.4.7 is
permissive, not mandatory, so label preparers can opt to rely on
language provided in Appendix C and used by their existing software
rather than expend additional time and resources to modify the
statements if they do not find it beneficial. In addition, OSHA's
understanding is that the software used to create SDSs and labels can
be updated, if necessary, to apply variations in precautionary
statements consistently across both SDSs and labels in order to comply
with the proposed requirement. OSHA has determined that variations
should be applied consistently on the label and in the safety data
sheet in order to avoid confusion and convey health and safety
information consistently to workers.
Cal/OSHA objected to proposed C.2.4.7 and stated that ``[s]tandard
language is essential for workers to become accustomed to particular
signal words. The proposed change could open the door for legal
disputes with OSHA over synonyms and the meaning of `other equivalent
terms,' `diluted' and `compromised' '' (Document ID 0322, Att. 2, pp.
8-9).
OSHA has considered Cal/OSHA's concerns and has concluded that
minor variations should be allowed as they can, in some cases, improve
communication of safety information to workers. OSHA notes that the
provision to allow minor variations in precautionary statements only
allows label preparers to use variations that at least equally convey
the required safety information to workers. For example, this provision
would allow for spelling variations, synonyms, or other equivalent
terms appropriate to the region where the product is supplied and used,
which may improve readability and comprehensibility for workers in some
situations. OSHA also does not agree that these terms would be
difficult to enforce or would result in significant litigation issues.
For the reasons discussed above, OSHA is finalizing paragraph C.2.4.7
as proposed.
OSHA also proposed to add a new paragraph, C.2.4.10, to address
cases where substances or mixtures that are classified for multiple
hazards may trigger multiple precautionary statements for medical
responses. Precautionary statements involve both an ``if'' statement,
either based on route of exposure or the symptoms being experienced,
and a medical response, such as ``call a poison center/doctor'' or
``get medical advice/attention.'' In a situation where a substance or
mixture is classified for multiple hazards and therefore triggers
multiple precautionary statements, this could result in redundancy of
either the ``if'' statement component or the medical response
component.
To address this concern, consistent with Rev. 7 (Document ID 0060,
pp. 302-303), OSHA proposed a system of prioritization and combination
for precautionary statements. Under proposed C.2.4.10(a), when the
hazards have similar routes of exposure or health outcomes, labels
would usually only need to include one precautionary statement
reflecting the medical response at the highest level with the greatest
urgency, combined with at least one route of exposure or symptom ``if''
statement. For example, in a situation where a substance was classified
as two different hazards (such as skin corrosion Category 1C and acute
toxicity Category 3 for dermal) which required different medical
responses to the same route of exposure, the statement, ``Immediately
call a poison center/doctor/. . .'' would be prioritized over the less
urgent ``call a poison center/doctor'' and would be the only medical
response required on the label for that route of exposure. Proposed
paragraph C.2.4.10(b) would allow for (but not require) combination of
medical response statements where multiple routes would trigger similar
medical statements. This means that if a chemical has, for example,
inhalation and skin contact hazards that would require the same level
of medical response, both of these routes of entry could be listed in a
combined statement. Thus, if a chemical is classified as acute toxicity
Category 2 inhalation and acute toxicity Category 2 dermal then the
statement can read ``if inhaled or on skin immediately call poison
center/doctor.'' Proposed paragraphs (a) and (b) can also be used in
combination. However, proposed paragraph C.2.4.10(c) would prohibit the
combination of medical response statements where the statements ``Get
medical advice/attention if you feel unwell'' and ``Get immediate
medical advice/attention'' are both indicated.
The agency requested comments on this system of prioritization in
proposed C.2.4.10 and on whether the proposed prioritization provisions
would improve clarity on labels.
Several commenters supported the addition of proposed paragraph
C.2.4.10. NIOSH stated that the proposed changes to paragraph C.2.4.10
would clarify hazards, citing a pre-GHS study of the comprehensibility
of material safety data sheets (MSDSs) which showed that ``wordiness
contributed to difficulty in understanding them [Kolp et al. 1993]''
(Document ID 0281, Att. 2, p. 5). Dow similarly commented that by
reducing the amount of text on labels, the prioritization specified in
C.2.4.10 would make the labels less confusing and easier to understand.
Dow further observed that some manufacturers are already doing this,
and that the proposed change would align with requirements of major
trading partners (Document ID 0359, p. 5). Ameren also agreed that
precautionary statements for medical responses should be prioritized
(Document ID 0309, p. 17).
OSHA also received several critical comments on proposed paragraph
C.2.4.10. Cal/OSHA and Worksafe raised concerns that the proposed
change would allow label preparers to present medical response
precautionary statement for only one of several hazards to users
(Document ID 0322, p. 3; 0354, p. 4), and that prioritization can lead
to misinterpretation (Document ID 0344, p. 3) or would leave workers,
emergency responders and downstream users without the information they
need to formulate an appropriate medical response to exposure (Document
ID 0322, p. 3; 0405, p. 20). The American Federation of State, County,
and Municipal Employees (AFSCME) noted similar concerns and recognized
the value specifically in including medical response precautionary
statements to address both immediate (acute) and long-term (chronic)
medical concerns when needed, since the appropriate medical care may
differ for a medical emergency versus potential chronic diseases such
as may occur from prolonged or repeated exposures (Document ID 0344, p.
3).
OSHA disagrees with these commenters that the proposed paragraph
C.2.4.10, if the general principles are followed as OSHA intended,
would result in information being omitted from the label. However, OSHA
acknowledges that the use of the term ``usually'' is ambiguous and
might create confusion. OSHA also agrees that only one precautionary
statement will not suffice in every situation. As OSHA discussed in the
NPRM, the agency believes there is value in including more than one
precautionary statement related to medical response to address both
immediate (acute) and long-term (chronic) medical concerns; appropriate
medical care may be different depending on whether there is a medical
emergency (e.g., chemical burns) or concerns about potential diseases
(e.g., cancer) due to prolonged exposures. Therefore, to clarify the
requirements for combination and prioritization of medical response
statements, OSHA is revising C.2.4.10(a) to read ``If the same medical
response statement is triggered multiple times, the label need only
include one precautionary statement reflecting the response at the
highest level with the greatest urgency, which should always be
combined with at least one route of exposure or symptom ``IF''
statement.'' OSHA believes this more specific version better expresses
the agency's expectations for when and how label preparers may combine
and prioritize medical response statements, to simplify the
presentation of medical response information while retaining the
information most important for end users to view on the label.
Additionally, OSHA notes that nothing in paragraph C.2.4.10 changes the
requirements of C.2.2 that all applicable hazard statements must appear
on the label, so producers are still required to include all hazards
associated with their products under the HCS.
OSHA received several requests for clarification regarding proposed
paragraph C.2.4.10. Toby Threet asked OSHA to clarify the meaning of
proposed paragraph C.2.4.10(c) (Document ID 0279, pp. 22-23). OSHA
intended paragraph C.2.4.10 (c) to create a limited exception to
C.2.4.10(a) (which allows for label preparers to present only the
highest priority medical response statement) and C.2.4.10(b) (which
allows combination of medical response statements for multiple routes
of exposure). Paragraph C.2.4.10(c) requires that, in the specific case
where the medical response precautionary statements ``Get medical
advice/attention if you feel unwell'' and ``Get immediate medical
advice/attention'' are both applicable to a chemical or mixture, due to
multiple hazards triggering multiple precautionary statements, they
must both appear as separate statements on the label. In the NPRM, OSHA
explained its intent that both of those statements should appear
``without prioritization,'' by which the agency meant that both should
appear on the label, and that the label preparer does not have
discretion to decide that they should be combined into a single
statement.
ICT asked OSHA to clarify the extent to which proposed paragraph
C.2.4.10 was intended to be mandatory, noting that terms such as
``should'' and ``may'' in C.2.4.10(a) and (b) seem to indicate that
combining or reducing is optional, while C.2.4.10(c) uses similar
language (``should appear'') to indicate something that is required
(Document ID 0324, p. 6).
OSHA intended for proposed paragraphs C.2.4.10, (a) and (b) to
allow, but not require the label preparer to prioritize and/or combine
elements of medical response precautionary statements on the label. In
contrast, OSHA intended proposed paragraph C.2.4.10(c) to be a
requirement. OSHA agrees with ICT that the use of ``should'' in
C.2.4.10(c) does not clearly convey the agency's intent and is
therefore modifying the proposed language of C.2.4.10(c) to replace
``should'' with ``must''.
ICT further noted that paragraph (f)(2) requires that labels must
bear the information specified in Appendix C, and that Appendix D
states that precautionary statements in the SDS must be in accordance
with paragraph (f). ICT inquired whether it follows that, in a case
where medical response statements have been prioritized and/or combined
for presentation on the label, the medical response statements may be
similarly presented in the SDS (Document ID 0324, pp. 5-6).
ICT is correct that the SDS is not required to include any more or
different medical statements than are presented on the label. If a
label is only required to have one medical response statement in
accordance with paragraph C.2.4.10, then the SDS may also contain only
that statement. OSHA further notes that it is permissible, but not
required, for SDS preparers to include additional medical response
statements beyond those included on the label.
OSHA also received several comments generally requesting
clarification regarding the principles in C.2.4.10 (Document ID 0339,
p. 3; 0358, p. 3; 0349, p. 2) and two commenters requested that OSHA
develop guidance (Document ID 0358, p. 3; 0349, p. 2). OSHA notes that
Annex 3 of Rev. 7, Annex 3 (A3.3.2.4) contains useful information on
the application of precautionary statements regarding medical response.
In A3.3.2.4, Application of precautionary statements concerning medical
response, the GHS provides a number of examples of how the principles
in C.2.4.10 can be applied
when choosing precautionary statements to ensure clarity of the most
appropriate safety message (Document ID 0094, pp. 302-303). Because
OSHA's language is intended to align with the GHS, the guidance
provided in the GHS about how to prioritize and combine precautionary
statements also provides information on how to comply with the HCS.
Additionally, OSHA will be updating its guidance and anticipates
providing additional guidance and examples on this topic.
OSHA requested input on alternative language for paragraph
C.2.4.10, based on Rev. 8, in which the medical response precautionary
statements would be standardized according to the Hazard Class and
Category (86 FR 9576). CGA and GAWDA recommended adoption of the Rev. 8
language on the basis that the standardized statements would make the
statement selection process easier when several options are available
(Document ID 0310, p. 3). NIOSH supported adoption of the Rev. 8
standardization but recommended that label preparers be given the
option to choose a stronger medical response precautionary statement if
supported by available information (Document ID 0281, Att. 2, p. 6;
0423, Tr. 23). In contrast, ACC advised OSHA not to adopt the Rev. 8
provision, which ACC believes would be overly prescriptive, would not
provide any additional protection, and would not reduce the cost or
difficulty of compliance for manufacturers (Document ID 0347, p. 7).
ACC testified that the revisions required under the Rev. 8 provision
would be a major financial burden because of the cost of updating
product labels and that the changes were semantic in nature, providing
the example that ``many Appendix C tables include a response statement
that directs the user to seek medical care, in addition to the phrase,
get medical advice/attention. Revising the label to include the
additional phrase is not a meaningful change in the precautionary
information being shared with the user'' (Document ID 0423, Tr. 105).
Michelle Sullivan supported optional use of the Rev. 8 precautionary
statements (Document ID 0366, p. 2).
After consideration of the comments received about adopting Rev. 8
revisions to medical precautionary statements, OSHA has decided to
finalize C.4.2.10 in alignment with Rev. 7, as proposed, because major
U.S. trading partners are also aligning with Rev. 7, and OSHA believes
the medical precautionary statements in Rev. 7 and Rev. 8 provide
equivalent information to downstream user. Furthermore, as discussed in
the HCS compliance directive (Document ID 0007, p. 6), OSHA allows for
the use of updated precautionary statements where the messaging directs
the user to similar actions. OSHA has determined that the precautionary
statements included in Rev. 8 provide similar information and follow
the general principles set out in C.2.4.10; therefore, label preparers
may use the Rev. 8 precautionary statements in lieu of the Rev. 7
precautionary statements.
In conclusion, OSHA is modifying paragraph C.2.4.10 as explained
above to clarify the requirements pertaining to the combination and
prioritization of medical response statements and to change the term
``should'' to ``must'' in C.4.2.10(c).
OSHA received two comments that recommended the agency add hazard
and precautionary phrase codes to Appendix C. DGAC commented that many
of their member companies use software that uses these phrase codes to
automate hazard classification to populate Section 2 and generate
translations, and noted that ``We are not suggesting that the codes be
required on the labels or SDS, only in Appendix C for reference only''
(Document ID 0339, pp. 4-5). Similarly, IHSC recommended that OSHA add
the hazard and precautionary statement codes to Appendix C, on the
basis that presenting the statement codes in the tables would help
users to compare the statements that may be in use under the different
versions of the GHS that countries have adopted, and could also assist
with translations of SDSs and labels (Document ID 0349, p. 2). This
request is out of scope for this rulemaking, as it does not pertain to
any of the changes OSHA proposed to the HCS in the NPRM; therefore, the
agency is not making the suggested addition.
OSHA also received a comment asking OSHA to change a specific
hazard statement. Steven Wodka asked OSHA to change the labeling
requirement for chemicals categorized by the HCS as a carcinogen from
``Danger May Cause Cancer'' to ``Danger Causes Cancer'' (Document ID
0312, p. 6). OSHA aligned its carcinogen warnings with the GHS in 2012
(77 FR 17742) but did not propose any changes to this language in the
2021 NPRM. Because OSHA did not propose to change this hazard
statement, Wodka's request is out of scope for this rulemaking.
Therefore, OSHA is not making the suggested change.
Paragraph C.3.3 of the 2012 HCS required that where an ingredient
with unknown acute toxicity is used in a mixture at a concentration >1
percent, and the mixture is not classified based on testing of the
mixture as a whole, a statement that X percent of the mixture consists
of ingredient(s) of unknown acute toxicity is required on the label. To
clarify the requirements of that paragraph, OSHA proposed in the NPRM
to add ``(oral/dermal/inhalation)'' and ``and safety data sheet'' to
the latter clause so that it reads ``a statement that X% of the mixture
consists of ingredient(s) of unknown acute toxicity (oral/dermal/
inhalation) is required on the label and safety data sheet'' (emphasis
added). DOD noted that paragraph C.3.3 ``should be more explicit about
the exact nature of the unknown toxicity . . . e.g., if dermal toxicity
is unknown, the label should be explicit that the product contains
materials of unknown dermal toxicity'' (Document ID 0299, p. 4). As
previously discussed in the Summary and Explanation for Appendix A
regarding the similar language added in A.1.3.6.2.3, OSHA intended for
the percentage of unknown acute toxicity to be differentiated by route
of exposure, given that it is possible to have ingredients with unknown
toxicity for more than one relevant route of exposure, and that is
reflected in the inclusion of the language ``(oral/dermal/inhalation)''
in the text of this paragraph. OSHA anticipates updating the HCS
guidance and will include discussion on this point to remove any
lingering confusion. Accordingly, OSHA is finalizing the revisions to
paragraph C.3.3 as proposed.
II. Section C.4
OSHA is updating the hazard label elements for specific hazard
classes and categories. The following discussion on revisions to C.4 is
organized according to: (1) Labeling changes resulting from the
addition of hazard classes and categories in Appendix B (new
subcategories for flammable gases (C.4.15), Aerosols category 3
(C.4.16), and desensitized explosives (C.4.30)); (2) revisions to
hazard statements, hazard categories, and notes; (3) revisions to
precautionary statements; and (4) the GHS revisions that OSHA is not
adopting.
(A) Revisions Based on Additions of Hazard Classes and Categories in
Appendix B
OSHA proposed several revisions to Appendix C based on the proposed
additions of hazard classes and categories to Appendix B. As discussed
in the Summary and Explanation for Appendix B, OSHA proposed and is
finalizing several changes to the flammable gas hazard class. The
changes include: (1) Subdividing category 1 flammable gases into
categories 1A and 1B; (2) adding
pyrophoric gases into category 1A; and (3) adding chemically unstable
gases into category 1A (further subdivided into chemically unstable gas
A and chemically unstable gas B). The hazard and precautionary
statements for those gases, which OSHA proposed to align with Rev. 7
(Document ID 0060, pp. 307-309), are located in C.4.15. OSHA proposed
that each type of category 1A gas (including pyrophoric gases and
chemically unstable gases) would require the hazard statement
``Extremely flammable gas,'' as is currently required for Category 1
gases. On the other hand, OSHA proposed that the hazard statement for
the new Category 1B flammable gases would be ``Flammable gas.'' OSHA
also proposed that additional hazard and precautionary statements would
be added to communicate hazards specific to, and precautions that need
to be taken for, pyrophoric and chemically unstable gases.
As was also discussed in the Summary and Explanation for Appendix
B, OSHA proposed and is finalizing the addition of non-flammable
aerosols to the existing ``Flammable Aerosols'' hazard class and
renaming the class ``Aerosols.'' Consequently, in Appendix C, OSHA
proposed to adopt the Rev. 7 hazard and precautionary statements for
non-flammable aerosols in C.4.16. OSHA reasoned that these statements
would better address the true hazards of aerosols. In cases where
aerosols were labeled as gases under pressure, OSHA proposed to require
that the label be updated to include the flame pictogram for Categories
1 and 2 (no pictogram would be required for hazard category 3) and the
signal word ``warning'' (if ``danger'' is not required due to
flammability). OSHA also proposed to require the hazard statement
``pressurized container, may burst if heated.'' OSHA reasoned that
these changes would better differentiate the hazards of non-flammable
aerosols from those of gases under pressure.
Finally, OSHA also proposed and is finalizing adoption of the
hazard class of desensitized explosives in Appendix B. OSHA
consequently proposed to adopt, in Appendix C, the pictogram, signal
word, hazard statements, and precautionary statements for desensitized
explosives from Rev. 7. OSHA proposed that the labeling information for
desensitized explosives would be added at C.4.30.
For flammable gases, aerosols, and desensitized explosives, OSHA
proposed to adopt the Rev. 7 hazard communication information with only
minor editorial revisions, such as the use of HCS instead of GHS
terminology (e.g., ``manufacturer, importer, or distributor'' instead
of ``manufacturer/supplier or the competent authority'' in conditional
instructions). As OSHA discussed in the NPRM, the agency believes that
the information called for by Rev. 7 effectively communicates the
hazards of those substances and the precautions that need to be taken
when handling them. Therefore, requiring the information to appear on
labels would improve hazard communication and enhance worker safety. In
addition, because the changes proposed would align the HCS with the
GHS, OSHA reasoned that adopting them would ease compliance burdens for
U.S. stakeholders that must also comply with international requirements
for hazard communication.
OSHA received several comments pertaining to these topics that
concern both Appendices B and C. To the extent that the agency received
comments on Appendix B that would involve ramifications to Appendix C,
those comments have been addressed in the Summary and Explanation for
Appendix B. This includes comments requesting that OSHA allow the
optional use of the pressurized cylinder icon for non-flammable and
flammable aerosols. OSHA disagrees with these comments, as discussed
above. Also as discussed in the Summary and Explanation for Appendix B,
OSHA received a comment from Toby Threet about changing the use of the
term ``aerosol'' to ``spray cans,'' which also included a request to
change the hazard statements in C.4.16 to use the word ``contents''
instead of ``aerosol'' (Document ID 0279, p. 12). For the same reasons
described in the Summary and Explanation for Appendix B, OSHA considers
this comment out of scope and declines to accept this proposal.
For the reasons discussed above the agency is finalizing these
revisions as proposed.
(B) Hazard Statements, Hazard Categories, and Notes
OSHA proposed to revise several hazard statements to align with
Rev. 7. The hazard statements in the 2012 HCS were adopted from Rev. 3.
Since then, the UNSCEGHS continued to discuss the utility and
readability of the label elements, including hazard statements, to
improve the information presented by clarifying language and
eliminating inconsistencies, and to save label space by consolidating
or combining language. Except where otherwise discussed below, OSHA
proposed to adopt the updated language presented in Annex 3 of Rev. 7
(Document ID 0060) with only minor editorial revisions, such as using
the HCS terminology instead of the GHS terminology (e.g.,
``manufacturer, importer or distributor'' instead of ``manufacturer/
supplier or the competent authority'' in conditional instructions).
III. C.4.1 (Acute Toxicity--Oral)
OSHA proposed to consolidate hazard category information for C.4.1
acute toxicity--oral, by deleting the table for Category 3 and
combining Categories 1, 2, and 3 in one table, since all three
categories have the same precautionary statements. The change does not
affect the substantive communication information for categories 1, 2,
or 3; it would simply make C.4.1 more concise. OSHA received no
comments on this proposed revision and is finalizing it as proposed.
IV. C.4.31 (Label Elements for OSHA Defined Hazards)
OSHA is making several changes to label elements for OSHA defined
hazards (C.4.30 in the 2012 HCS and now in C.4.31). This section of
Appendix C addresses the labeling of hazards that are not classified
under the GHS, but that the HCS specifically defines as hazards that
must be communicated on the label and SDS.
In the NPRM, OSHA proposed to delete the entry for ``Pyrophoric
Gas.'' In Rev. 7, pyrophoric gases were made a category under the
hazard class of flammable gases, and OSHA proposed to include them
there in the HCS as well. OSHA received no comments on removing
pyrophoric gas from proposed C.4.31. Therefore, the agency is
finalizing it as proposed.
OSHA also proposed a change to the ``Combustible Dust'' hazard
statement. When OSHA finalized the revisions to the HCS in 2012, the
GHS did not address classification of combustible dust; however, it
used combustible dust as an example of ``Other hazards which do not
result in classification'' in Annex 4 of Rev. 7 (A4.3.2.3) (Document ID
0085, Att. 8, p. 408). The GHS had previously recognized combustible
dust. In Rev. 5, the UN updated A4.3.2.3 to include the statement ``May
form explosible dust/air mixture if dispersed'' for dust explosion
hazards to provide guidance on the type of statement that should be
used in the case of dust explosion hazards (Document ID 0251).
Subsequently, OSHA initiated UNSCEGHS discussions regarding combustible
dust hazards. The UNSCEGHS adopted an annex (Annex 11) that provides
additional guidance on hazard identification, the factors that
contribute to a dust explosion hazard, and the need for risk
assessment,
prevention, mitigation, and communication (Document ID 0157). In the
2021 NPRM, OSHA therefore proposed to allow either the previously
required statement, ``May form combustible dust concentrations in
air,'' or a statement based on Rev. 7 suggested language, ``May form
explosible dust-air mixture'' (Document ID 0060, p. 386). OSHA proposed
to add square brackets after both statements containing the following
language: ``if small particles are generated during further processing,
handling or by other means.'' This bracketed language was proposed to
indicate that this language should be added when the material can only
create a combustible dust hazard due to the creation of small particles
during the processing or handling of the chemical. OSHA did not propose
any changes to the signal word of ``warning'' or any pictogram
requirements.
Michele Sullivan asked OSHA to provide guidance on the meaning of
square brackets around text in the combustible dust hazard statements,
to explain in what circumstances the enclosed text should be used
(Document ID 0366, p. 8).
Under C.2.4.5, where square brackets appear around text in a
precautionary statement, this indicates that the text in square
brackets is not appropriate in every case and should be used only in
certain circumstances. In these cases, conditions for use explaining
when the text should be used are provided (see, e.g., C.4.3, C.4.4,
C.4.19, C.4.20, C.4.21, and C.4.28). In the case of combustible dust,
OSHA did not propose to provide an explanation for the brackets. OSHA
agrees that additional explanation is warranted, and has revised the
hazard statement for combustible dust to include the following
explanation for the brackets for combustible dust: ``Text in square
brackets may be used when the material can only create a combustible
dust hazard due to the creation of small particles during the
processing or handling of the chemical.''
API supported the proposed revision, noting that it is consistent
with prior OSHA guidance (Document ID 0316, pp. 24-25). Dow expressed
support for the codification of OSHA's prior statements that label
preparers can provide additional information on the Hazard Statement to
indicate that the hazard occurs during downstream processing but voiced
concern regarding the proposed change in C.4.31 which would allow for
use of either the term ``combustible dust'' or ``explosible dust'' as
part of the hazard phrase, on the basis that allowing for the use of
either name without clear definitions for each could lead to confusion.
Dow asked OSHA to provide definitions for the terms combustible dust
and explosible dust to differentiate between them or, alternatively,
withdraw its proposal to allow for use of the term explosible dust and
require use of the term combustible dust (Document ID 0359, pp. 5-6).
OSHA acknowledges that neither the GHS nor the HCS include a
definition of ``Explosible'' or ``Explosible Dust'', but notes that the
term ``explosible'' is widely used in industry, and OSHA uses the term
``explosible'' in its publication on the Hazard Communication Guidance
for Combustible Dusts (Document ID 0255). OSHA therefore does not find
it necessary to provide a new definition in the HCS. For the purposes
of the HCS, OSHA believes there is no significant difference between
``explosible dust-air mixture'' and ``combustible dust concentrations
in air'' and intends that these terms can be used interchangeably by
label preparers. Further discussion on these terms can be found in OSHA
Publication 3644-04, 2013, Firefighting Precautions at Facilities with
Combustible Dust (available at https://www.osha.gov/sites/default/files/publications/OSHA_3644.pdf).
AF&PA and AWC also supported the changes to paragraph C.4.31,
noting that ``The proposed hazard statements . . . are similar to
existing OSHA guidance and represent a significant improvement over the
current regulatory text'' (Document ID 0287, p. 5). They also
recommended clarifying edits to the footnote in C.4.31 regarding
combustible dust: adding ``1)'' at the beginning of the footnote;
reformatting the footnote to be three separate sentences instead of
one; and adding the phrase ``that follows the approach described'' in
the second numbered segment of the sentence to clarify that the
sentence is not limited to wood, metal, and plastic items and whole
grain. The text would then read ``. . . the chemical manufacturer or
importer shipping chemicals that are in a form that is not yet a dust
must provide a label to customers that follows the approach described
under paragraph (f)(4) of this section . . .'' OSHA agrees that these
edits clarify the text and has finalized the labeling provisions for
combustible dust as AF&PA and AWC suggested.
OSHA is making further revisions to Appendix C in response to
comments which pointed out an oversight in the agency's proposed
revisions to the appendix. WHSP and an additional anonymous commenter
noted that the ``Corrosive to the respiratory tract'' hazard statement
that OSHA introduced in its proposal to add paragraph A.1.2.4 to
Appendix A did not appear in Appendix C of the proposed standard. The
commenters asked ``what signal word, pictogram, and precautionary
statements should appear on the SDS and label when the `Corrosive to
the respiratory tract' hazard statement is used?'' (Document ID 0265;
0341, p. 39). As stated above in the Summary and Explanation for
Appendix A, OSHA is adding a note to each of the relevant tables in
Appendix C to clarify the labelling requirements related to new
paragraph A.1.2.4. In accordance with the provisions of paragraph
A.1.2.4 included in the final rule, OSHA is adding notes to Tables
C.4.3, C.4.4,C.4.5 and C.4.11.
First, OSHA added a note below Table C.4.3, Acute Toxicity--
Inhalation, Categories 1 and 2 to indicate the required label elements
for corrosive to the respiratory tract. The note requires that if the
substance/mixture is determined to be corrosive to the respiratory
tract leading to lethality, the corrosivity hazard must also be
communicated with the corrosion pictogram and hazard statement
``corrosive to the respiratory tract.'' Second, OSHA added a note to
Table C.4.4, Skin Corrosion/Irritation, Categories 1A to 1C. The note
indicates that if the classifier determines, based on skin data, that
the chemical may be corrosive to the respiratory tract, then the
corrosivity hazard must be communicated with the hazard statement
``corrosive to the respiratory tract'' and the corrosion pictogram. (As
instructed in Appendix C.2.3.4, pictograms may only appear once on a
label. If multiple hazards require the use of the same pictogram, it
may not appear a second time on the label.) Third, OSHA added a note
below Table C.4.5, Eye damage/Irritation, Category 1, indicating that
if a classifier determines that a chemical may be corrosive to the
respiratory tract based on eye data, then the corrosivity hazard must
be communicated with the hazard statement ``corrosive to the
respiratory tract'' and the corrosion pictogram. Fourth, OSHA added a
note below Table C.4.11, Specific Target Organ Toxicity (Single
Exposure), Category 1. The note states that if the chemical is
determined to be corrosive to the respiratory tract, corrosive to the
respiratory tract must be communicated with the hazard statement
``corrosive to the respiratory tract, if inhaled,'' and the corrosivity
pictogram in lieu of the current STOT hazard statement and health
hazard pictogram. The hazard statement for corrosive to the respiratory
tract under STOT SE, unlike the other corrosive to the respiratory
tract statements,
includes ``if inhaled'' because A.8.2.1.2 requires the relevant
route(s) of exposure by which the classified substance produces damage
to be identified.
(A) Revisions to Precautionary Statements
As mentioned in Rev. 7, A3.3.1.5 (Document ID 0060, p. 301), the
original GHS (Document ID 0215) precautionary statements were developed
from existing classification systems, including the IPCS International
Chemical Safety Card (ICSC) Compilers Guide, the American National
Standards, the EU classification and labelling directives, the
Emergency Response Guidebook, and EPA's Pesticide Label Review Manual.
Since OSHA's 2012 updates to the HCS, the UNSCEGHS continued its
ongoing review of the precautionary statements to ensure they are
allocated to the correct hazard class and/or category, reduce
redundancies, simplify and clarify the statements, and clarify and
refine the conditions of use. This section discusses OSHA's revisions
to precautionary statements in Appendix C.4. As OSHA explained in the
NPRM, the intent or reasons provided below for the changes it proposed
in the NPRM (and is now finalizing) reflect OSHA's agreement with
explanations provided by the UNSCEGHS, unless otherwise specified. The
changes are organized according to the column headings found in the C.4
tables (i.e., prevention, response, storage, and disposal).
(B) Changes in Prevention Column
1. Wear Protective Equipment (e.g., Gloves/Protective Clothing)
A precautionary statement for acute toxicity--dermal (all
categories) (C.4.2), skin corrosion/irritation (Categories 1A to 1C and
Category 2 (as outlined in Appendix C tables in the NPRM)) (C.4.4), eye
damage/irritation (Categories 1 and 2A) (C.4.5), and sensitization--
skin (C.4.7) specifies personal protective equipment, such as ``wear
protective gloves'' or ``wear eye protection/face protection.'' OSHA
proposed to revise the instruction accompanying ``Wear protective
gloves/protective clothing,'' which previously instructed the chemical
manufacturer, importer, or distributor ``to specify type of
equipment.'' The proposed instruction stated that the chemical
manufacturer, importer, or distributor ``may further specify type of
equipment where appropriate'' to align with Rev. 7 (Document ID 0060,
pp. 347-348, 350-351, 354).
Cal/OSHA, AFSCME and Worksafe objected that, under the proposed
version, producers would not be required to specify the types of PPE
that are required to handle specific types of chemicals (Document ID
0322, p. 3; 0344, p. 3; 0354, p. 5; 0405, p. 18; 0424, Tr. 196-197).
According to Cal/OSHA, the proposed revision ``would leave workers who
handle chemicals during shipment and at the point-of-use with less
information about the type of gloves, protective garments, eyewear and
other PPE needed to protect themselves from exposure, and it would
complicate an emergency response to a loss of containment during
transportation or use'' (Document ID 0322, p. 3).
OSHA did not intend for the proposed revision to suggest that label
preparers are no longer required to identify the specific types of PPE
needed to protect employees. Rather, the proposed revision was to align
with Rev. 7, A4.3.8.3.3. As explained there, ``[s]pecial requirements
may exist for gloves or other protective clothing to prevent skin, eye
or lung exposure. Where relevant, this type of PPE should be clearly
stated. For example, `PVC gloves' or `nitrile rubber gloves', and
thickness and breakthrough time of the glove material'' (Document ID
0060, p. 385). While this level of specificity is appropriate for some
chemicals and mixtures, there are also chemicals and mixtures for which
the more general prevention statement to wear protective gloves is
adequate. OSHA's intent in aligning with the GHS language is to
continue to require the label preparer to specify the appropriate PPE
and maintain the longstanding requirement of the HCS that label
preparers must specify the type of protective gloves and/or equipment
when a specific type (such as PVC or nitrile) must be used to protect
workers. The label preparer may use a more general statement only when
a specific type of PPE is not needed to protect workers.
OSHA therefore agrees with Cal/OSHA that the use of ``may'' in the
proposed revision could be misinterpreted to mean that label preparers
are not required to specify the type of gloves and clothing which will
be protective whenever a specific type is needed for a given chemical
or mixture. Accordingly, OSHA is amending the instruction accompanying
``Wear protective gloves/protective clothing'' in Appendix C to read
``Chemical manufacturer, importer, or distributor to specify type of
equipment where appropriate''. OSHA added this statement to C.4.2,
C.4.4, C.4.5 and C.4.7.
OSHA also proposed to adopt a precautionary statement revision and
instruction adding the term ``/hearing protection . . .'' for several
hazard classes, in alignment with similar changes made in Rev. 7. In
2015, the UNSCEGHS noted that hearing protection should often be worn
when handling explosives and other physical hazards, such as
desensitized explosives, because an explosion would result in a
potentially hazardous noise level (Document ID 0219). Accordingly, the
UNSCEGHS revised the precautionary statement to read, ``Wear protective
gloves/protective clothing/eye protection/face protection/hearing
protection . . .'' (Document ID 0147). Consistent with Rev. 7 (Document
ID 0060, pp. 284-285), OSHA proposed to adopt this revised
precautionary statement and instruction for germ cell mutagenicity
(C.4.8), all categories; carcinogenicity (C.4.9), all categories;
reproductive toxicity (C.4.10), all categories; explosives (C.4.14),
unstable explosives and Divisions 1.1-1.5; flammable gases (C.4.15),
Category 1A, pyrophoric; flammable liquids (C.4.19), all categories;
flammable solids (C.4.20), all categories; self-reactive substances and
mixtures (C.4.21), all categories; pyrophoric liquids (C.4.22),
Category 1; pyrophoric solids (C.4.23), Category 1; self-heating
substances and mixtures (C.4.24), all categories; substances and
mixtures which, in contact with water, emit flammable gases (C.4.25),
all categories; oxidizing liquids (C.4.26), all categories; oxidizing
solids (C.4.27), all categories; organic peroxides (C.4.28), all
categories; and desensitized explosives (proposed C.4.30), all
categories.
NIOSH commented that the addition of hearing protection to the list
of PPE shown in the `prevention' columns for the hazard classes of germ
cell mutagenicity (C.4.8), carcinogenicity (C.4.9), and reproductive
toxicity (C.4.10) ``seems inappropriate because hearing protection will
not protect against exposure to these hazardous substances'' (Document
ID 0281, p. 5).
OSHA notes that the use of the backslash ``/'' as outlined in
C.2.4.2 indicates that the label and SDS preparer can choose the
appropriate phrases. OSHA agrees that hearing protection is not an
appropriate recommendation for the hazard classes of germ cell
mutagenicity (C.4.8), carcinogenicity (C.4.9), and reproductive
toxicity (C.4.10), and would not expect that this would be included by
label and SDS preparers for these hazard classes. Since OSHA does not
believe hearing protection is appropriate for these hazards and in
order to minimize the misuse of this statement, OSHA is not adding the
term ``hearing protection'' for those hazard classes.
For C.4.15, Flammable Gases, NIOSH recommended adding PPE to
include protective gloves/protective clothing/eye protection/face
protection'' for Hazard Categories 1A, Chemically Unstable Gas A, and
1B, Chemically Unstable Gas B (Document ID 0281, Att. 2, p. 6). While
OSHA updated the presentation of the hazard category for flammable gas
it did not propose to make substantial changes to the actual statements
required and therefore views these changes as out of scope. The only
exceptions to this are the changes made to the prevention column for 1A
pyrophoric gases, where PPE was added to address the specific hazard of
pyrophoricity and that language mirrors the precautionary statements of
pyrophoric solids and pyrophoric liquids, and it is thus not one of the
categories NIOSH recommends making changes to. The agency also notes
that PPE is not included in Rev. 7 for the hazard categories NIOSH
indicated (Document ID 0060, pp. 307-309). However, label preparers can
add additional statements they deem appropriate.
NIOSH additionally recommended adding ``respiratory protection'' to
the list of PPE shown in the prevention column for C.4.8 Germ Cell
Mutagenicity, C.4.9 Carcinogenicity, and C.4.10 Reproductive Toxicity
(Document ID 0281, Att. 2, p. 5). AFSCME similarly commented that since
inhalation is a main route of entry when working with chemicals,
respiratory protection language should be included in the PPE
specifications in the tables that do currently list specific types of
PPE (Document ID 0344, pp. 3-4). NIOSH also suggested PPE-related
changes for several hazard classes in which OSHA either did not propose
any revision to the prevention column or did not propose any PPE-
related revisions. NIOSH recommended adding PPE to include respiratory
protection/protective clothing/protective gloves to the prevention
column for C.4.11 (Specific Target Organ Toxicity, Single Exposure) and
C.4.12 (Specific Target Organ Toxicity, Repeated Exposure). For C.4.16,
Aerosols, and C.4.17, Oxidizing Gases, NIOSH recommended adding PPE to
include protective gloves/protective clothing/eye protection/face
protection to the prevention column. For C.4.18, Gases Under Pressure
(compressed gas, liquified and dissolved gas), NIOSH recommended adding
PPE to include eye protection/face protection (Document ID 0281, p. 6).
Regarding NIOSH and AFSCME's requests to add the term ``respiratory
protection'' as an option in the PPE prevention column for Germ Cell
Mutagenicity, Carcinogenicity, and Reproductive Toxicity, and in the
prevention column for various other hazard classes, such a revision
would be out of scope for this rulemaking since OSHA did not raise the
possibility of adding ``respiratory protection'' to any of these PPE
precautionary statements in the NPRM. However, OSHA notes that it is
finalizing the ellipses that it proposed to include at the end of the
lists of PPE in the prevention column for these hazards, which allows
addition of other types of PPE (including respiratory protection) and
which should be added if appropriate. With regard to the other types of
PPE that NIOSH recommended adding, these changes too would be outside
the scope of this rulemaking because they are unrelated to what OSHA
proposed in the NPRM.
Cal/OSHA commented that OSHA should strengthen the precautionary
statements to indicate that the PPE is required and suggested the
agency change the language to ``Chemical manufacturer, importer, or
distributor to specify the appropriate personal protective equipment as
required'' (Document ID 0322, Att. 2, p. 11-13). OSHA disagrees with
Cal/OSHA's suggested change. The precautionary statement indicates that
PPE should be worn with the declarative statement of ``Wear protective
gloves/. . .'' which makes clear what PPE is needed in order to safely
use the chemical. Cal/OSHA's suggested revision only changes the
language around the duty of the label preparer to specify the details
of the PPE, and in this case ``as required'' does not add strength to
this requirement because the language already makes clear that the
label preparer must specify the appropriate PPE. For these reasons,
OSHA declines to alter the precautionary statement as Cal/OSHA
suggests.
For C.4.13, Aspiration Hazard, NIOSH recommended adding a statement
that ``Mouth pipetting is to be prohibited. When pipetting is required,
use a pipette bulb or a mechanical device'' (Document ID 0281, p. 6).
While OSHA agrees this is sound laboratory practice, it was not
discussed in the NPRM and would therefore be out of scope for this
rulemaking. OSHA also notes that the suggested statement is not
included in the GHS, and that 29 CFR 1910.1450, Occupational exposure
to hazardous chemicals in laboratories, Appendix A, Paragraph E,
provides a list of general procedures from the National Research
Council for working with chemicals, including ``Pipetting should never
be done by mouth.''
2. Avoid Contact During Pregnancy/While Nursing
In C.4.10, for reproductive toxicity (effects on or via lactation),
OSHA proposed to revise a precautionary statement that said to avoid
contact ``during pregnancy/while nursing'' so it would read ``during
pregnancy and while nursing''. OSHA proposed this revision to clarify
that the chemical label preparer is not to choose between ``during
pregnancy'' and ``while nursing'' but is to include both scenarios on
the label. OSHA also noted that the proposed change would align with
Rev. 7 (Document ID 0060, p. 358). OSHA received no comments on this
proposed revision. Therefore, the agency is finalizing it as proposed.
3. Do Not Handle Until All Safety Precautions Have Been Read and
Understood
For unstable explosives in C.4.14, OSHA proposed to delete a
precautionary statement included in the 2012 HCS about not handling
until all safety precautions have been read and understood. OSHA
reasoned that a statement to obtain special instructions before use is
already included and that statement is shorter and more relevant to
safety. OSHA also noted that the proposed change would align with Rev.
7 (Document ID 0060, p. 304). OSHA received no comments on this
proposed revision. Therefore, the agency is finalizing it as proposed.
4. Do Not Subject to Grinding/Shock/Friction
OSHA also proposed adding the precautionary statement ``Do not
subject to grinding/shock/friction/. . .'' to the table for unstable
explosives in C.4.14. As OSHA explained in the NPRM, that statement was
already included for the other explosives categories in the HCS and is
also relevant for unstable explosives. For each of the explosives
categories that contain that statement, OSHA proposed to add an
explanatory conditional note clarifying that the statement applies only
if the explosive is mechanically sensitive. OSHA noted that these
proposed changes would align with Rev. 7 (Document ID 0060, p. 304).
OSHA received no comments on this proposed revision. Therefore, the
agency is finalizing it as proposed.
5. Keep Away From Heat/Sparks/Open Flames/Hot Surfaces
In the NPRM, OSHA noted that several of the hazard classes that
include flammable chemicals require precautionary statements and
instructions about keeping away from ignition sources (heat/sparks/open
flames/hot surfaces). Those statements generally require the label
preparer to select one or more of the ignition sources listed, as
applicable. OSHA proposed to include more ignition sources in the
statement and to require that they all be listed on the label. The
revised statement would read, ``Keep away from heat, hot surfaces,
sparks, open flames, and other ignition sources.'' OSHA stated its
belief that this change, which is consistent with Rev. 7 (Document ID
0060, p. 280), would improve hazard communication by making users aware
of additional ignition sources that should be avoided. The change was
proposed for precautionary statements for explosives (divisions 1.1-1.5
in C.4.14), flammable gases (C.4.15), aerosols (C.4.16), flammable
liquids (C.4.19), flammable solids (C.4.20), self-reactive substances
and mixtures (C.4.21), pyrophoric liquids (C.4.22), pyrophoric solids
(C.4.23), oxidizing liquids (C.4.26), oxidizing solids (C.4.27),
organic peroxides (C.4.28), and desensitized explosives (C.4.30).
NPGA objected to the proposed change because it would require all
ignition sources to be listed. NPGA commented that ``the chemical
manufacturer, importer or distributor is best equipped to determine
which ignition sources should be listed. Further to this, it is not
clear how this change improves safety to the level that it justifies
the cost of redesigning, printing and relabeling all
containers''(Document ID 0364, p. 5).
OSHA disagrees with NPGA that the chemical manufacturer, importer,
or distributor would be best equipped to determine which ignition
sources are relevant, since there may be ignition sources at worksites
where the chemical is used that the manufacturer, importer, or
distributor is unaware of. OSHA believes the value of this
clarification is evident because expanding the list of potential
ignition sources increases worker awareness of and protection from the
variety of ignition sources that may be present at their worksite.
Furthermore, due to the significant changes included in this final rule
to several aspects of C.4.15, label preparers will already need to
redesign these labels and print new ones. Therefore, this change alone
does not specifically incur the costs that NPGA cites as either those
costs would exist without the addition of this provision or are not
costs due to other flexibilities provided. In addition, contrary to
NPGA's assertion, all containers would not need to be relabeled. OSHA
is finalizing a new sentence in paragraph (f)(11) that allows
manufacturers, importers, and distributors to not relabel containers
that have already been released for shipment. For these reasons, OSHA
disagrees with NPGA's arguments and is finalizing these revisions as
proposed.
6. Keep Wetted With
In the 2012 HCS a conditional instruction used for Divisions 1.1-
1.3 and 1.5 explosives in C.4.14 stated that the chemical manufacturer,
importer, or distributer is to include the precautionary statement
``Keep wetted with . . . '' under conditions where drying out would
increase the explosion hazard, except as needed for manufacturing or
operating processes. Rev. 7 changed the conditional instruction to
clarify that the ``Keep wetted with . . . '' statement should be used
for ``substances or mixtures which are wetted, diluted, dissolved or
suspended with a phlegmatizer to reduce or suppress their explosive
properties'' (Document ID 0060, p. 305). OSHA proposed to make the same
change in order to clarify when the ``Keep wetted with . . . ''
statement is appropriate. OSHA received no comments on this proposed
revision. Therefore, the agency is finalizing it as proposed.
OSHA further notes that the ``Keep wetted with . . . ''
precautionary statement also appears in C.4.30, desensitized
explosives. Consistent with Rev. 7 (Document ID 0060, p. 334), OSHA did
not propose to add the conditional statement that appears in C.4.14
because, by definition, desensitized explosives are phlegmatized to
suppress their explosive properties, and therefore the ``Keep wetted
with . . . '' statement is appropriate for all desensitized explosives.
7. Keep Only in Original Packaging
OSHA proposed to revise the statement ``Keep only in original
container'' to ``Keep only in original packaging'' for self-reactive
substances and mixtures (C.4.21), organic peroxides (C.4.28), and
corrosive to metals (C.4.29). OSHA also proposed that the revised
statement would be added to explosives in Divisions 1.1-1.5 (C.4.14).
OSHA reasoned that the proposed change in term is appropriate because
the term ``packaging'' is more inclusive than ``container'' and would
include the transport packaging as well as the immediate container.
OSHA also noted that the proposed changes are consistent with Rev. 7
(Document ID 0060, p. 281). OSHA received no comments on these proposed
revisions. Therefore, the agency is finalizing them as proposed.
8. Ground and Bond Container and Receiving Equipment
Several hazard classes require the precautionary statement
``Ground/bond container and receiving equipment'' for chemicals that
are electrostatically sensitive. OSHA proposed changing ``Ground/bond''
to ``Ground and bond'' to clarify that both of those precautions are to
be included on the label. C.2.4.2 states that when a ``/'' is used the
label preparer has a choice and should choose the most appropriate
phrase. However, in this case, both ``ground'' and ``bond'' should be
stated together to appropriately protect against electrostatically
sensitive chemicals. OSHA proposed making this change for explosives
(Divisions 1.1 to 1.5 in C.4.14), flammable liquids (Categories 1 to 3
in C.4.19), and flammable solids (C.4.20). In addition, OSHA proposed
to revise the conditional instructions to clarify that the need for
grounding and bonding applies to flammable liquids only if they are
volatile and may generate an explosive atmosphere (C.4.19) and to
explosives and flammable solids only if they are electrostatically
sensitive (C.4.14 and C.4.20). OSHA also proposed to add the ``ground
and bond'' precautionary statement and similar conditional notes (``if
electrostatically sensitive and able to generate an explosive
atmosphere'') to self-reactive substances and mixtures (C.4.21) and
organic peroxides (C.4.28) because the precaution is also appropriate
for those hazard classes. OSHA noted that the proposed changes would
align with Rev. 7 (Document ID 0060, p. 282). OSHA received no comments
on these proposed revisions. Therefore, the agency is finalizing them
as proposed.
9. Keep Away From Clothing and Other Combustible Materials
OSHA proposed to standardize precautionary statements regarding
combustible materials for oxidizing chemicals. In the 2012 HCS, the
tables for oxidizing gases (C.4.17), oxidizing liquids (C.4.26, hazard
categories 2 and 3), and oxidizing solids (C.4.27, hazard categories 2
and 3) required the precautionary statement ``Keep/Store away from
clothing/ . . . /combustible materials,'' along with instructions for
the chemical manufacturer, importer, or distributor to specify
incompatible materials. The table for Category 1 in C.4.26 required the
precautionary statement ``Keep/Store away from clothing and other
combustible
materials.'' OSHA proposed to change these statements to read: ``Keep
away from clothing and other combustible materials,'' and to delete the
instruction regarding incompatible materials, to make the statement
consistent with the statement currently applicable to Category 1 in
oxidizing solids (C.4.27). OSHA reasoned that the proposed change is
appropriate because the general term``combustible materials''
encompasses any other materials that are incompatible with oxidizers.
In addition, OSHA reasoned that the term ``keep'' is adequate to
encompass storage as well as use, and that eliminating the choice
between``keep'' and``store'' would avoid confusion and improve
consistency. OSHA also proposed to remove the redundant statement``Take
any precaution to avoid mixing with combustibles/ . . . '' under
oxidizing liquids (C.4.26) and oxidizing solids (C.4.27), since this
information is duplicative of the ``keep away from'' statement. OSHA
noted that the proposed changes would be consistent with Rev. 7
(Document ID 0060, p. 280).
OSHA proposed to remove the``Keep/store away from clothing/ . . . /
combustible materials'' precautionary statement, along with its
instruction, for self-reactive substances and mixtures (C.4.21) and
organic peroxides (C.4.28). As OSHA explained in the NPRM, the wording
of the precautionary statement is pertinent to oxidizing properties,
which readily give oxygen or other oxidizing material, and therefore
more readily support combustion. Neither self-reacting chemicals nor
organic peroxides have oxidizing properties, so the statement is not
appropriate for them. Both self-reacting chemicals and organic
peroxides have alternate storage statements that are designed to more
accurately address their particular chemical properties. OSHA noted
these proposed changes would also align with Rev. 7 (Document ID 0060,
pp. 318-320, 330-332).
OSHA received no comments on these proposed revisions. Therefore,
the agency is finalizing them as proposed.
10. Keep Valves and Fittings Free From Oil and Grease
For oxidizing gases (C.4.17), a precautionary statement in the 2012
HCS allowed the chemical manufacturer, importer, or distributor to
specify that either ``reduction valves'' or ``valves and fittings'' be
kept free from oil and grease. OSHA proposed to revise the statement to
``Keep valves and fittings free from oil and grease.'' OSHA reasoned
that the change would be appropriate because all valves and fittings
must be kept free of oil and grease, not just the reduction valves
attached to pressure receptacles, and also noted it would be consistent
with Rev. 7 (Document ID 0060, p. 312). OSHA received no comments on
this proposed revision. Therefore, the agency is finalizing it as
proposed.
11. Wear Cold Insulating Gloves/Face Shield/Eye Protection
OSHA proposed to revise the precautionary statement for
refrigerated liquefied gases (C.4.18), which in the 2012 HCS required
the use of either cold insulated gloves, a face shield, or eye
protection. The revised precautionary statement reads ``Wear cold
insulating gloves and either face shield or eye protection.'' OSHA
proposed the change to clarify the intent of the precautionary
statement, which is that cold-insulating gloves are to be used in
addition to either a face shield or eye protection, and noted that it
would align with Rev. 7 (Document ID 0060, p. 314). OSHA received no
comments on this proposed revision. Therefore, the agency is finalizing
it as proposed.
12. Keep Container Tightly Closed
The precautionary statement ``Keep container tightly closed'' is
used for flammable liquids (categories 1 to 3 in C.4.19). Rev. 7
contains a conditional instruction for flammable liquids indicating
that the statement is to be used if the liquid is volatile and may
generate an explosive atmosphere (Document ID 0060, p. 321). OSHA
proposed to add this conditional instruction to the precautionary
statement for flammable liquids (categories 1 to 3) because it
clarifies the types of flammable liquids for which the statement
applies.
OSHA also proposed to add the precautionary statement ``Keep
container tightly closed'' to pyrophoric liquids (C.4.22), pyrophoric
solids (C.4.23), and desensitized explosives (new C.4.30) (as part of
adopting the new hazard class of desensitized explosives). OSHA
reasoned that it is important to add that statement because for both
pyrophoric liquids and pyrophoric solids it is necessary to avoid
ignition via contact with air. Because the precaution applies to all
chemicals in these hazard classes, OSHA preliminarily determined that a
conditional note is not necessary. The agency noted that these proposed
changes would also align with Rev. 7 (Document ID 0060, p. 281).
OSHA received no comments on these proposed revisions. Therefore,
the agency is finalizing them as proposed.
13. Take Precautionary Measures Against Static Discharge
For flammable liquids (C.4.19, Hazard Categories 1 to 3), OSHA
proposed to revise the precautionary statement ``Take precautionary
measures against static discharge'' to ``Take action to prevent static
discharge.'' As explained in the NPRM, the proposed revision would
simply shorten the statement and clarify what action needs to be taken.
OSHA also proposed to add a note that this precautionary statement is
to be used if the liquid is volatile and may generate an explosive
atmosphere. OSHA noted that these proposed changes are consistent with
Rev. 7 (Document ID 0060, p. 315). OSHA received no comments on this
proposed revision. Therefore, the agency is finalizing it as proposed.
14. Flammable Liquids/Solids Precautionary Statements and Conditional
Instructions
OSHA proposed additional conditional instructions for flammable
liquids (C.4.19) and flammable solids (C.4.20). For some categories of
flammable liquids (Categories 1 to 3) and flammable solids (categories
1 and 2), OSHA proposed to modify one of the precautionary statements
to add square brackets in the phrase ``Use explosion-proof [electrical/
ventilating/lighting/. . .] equipment.'' As OSHA explained in the NPRM,
the agency believes that SDS and label creators are not properly and
specifically identifying the prevention measures for the particular
chemical, but rather are listing the entire line without the required
details, and the brackets are intended to help clarify this issue. For
both liquids and solids, OSHA proposed adding a conditional instruction
to indicate that the text in square brackets may be used to specify
specific electrical, ventilating, lighting, or other equipment if
necessary and as appropriate. For liquids, OSHA also proposed a new
conditional instruction to clarify that the statement is required if
the chemical is volatile and may generate an explosive atmosphere. OSHA
noted that these proposed changes would align with Rev. 7 (Document ID
0060, p. 282).
OSHA also proposed to add a conditional instruction to the
precautionary statement to use non-sparking tools for flammable liquids
(C.4.19, categories 1 to 3). The statement would clarify that the
precautionary statement is only needed if the liquid is volatile and
may generate an explosive atmosphere, and if the minimum ignition
energy is very low (<0.1 mJ). The precautionary statement has very
limited applicability for flammable liquids and therefore OSHA reasoned
that the conditions need to be specified. OSHA noted that this proposed
change is also consistent with Rev. 7 (Document ID 0060, p. 315).
OSHA received no comments on these changes to the precautionary
statements and additional conditional instructions it proposed for
flammable liquids (C.4.19) and flammable solids (C.4.20). Therefore,
the agency is finalizing them as proposed.
15. Keep Cool
For self-reactive substances and mixtures (C.4.21) and organic
peroxides (C.4.28), OSHA proposed to move the precautionary statement
``Keep cool'' from the storage column to the prevention column. OSHA
reasoned that the precautionary statement is not needed in the storage
column because that column includes a precautionary statement about
storage temperatures not to be exceeded under storage conditions, and
as discussed below, OSHA also proposed to add conditional instructions
to that column to inform users of when a storage temperature would need
to be listed. To ensure that the chemicals are kept at appropriate
temperatures at all times (not just during storage), OSHA proposed to
place ``Keep cool'' in the prevention column; but OSHA also proposed to
include a conditional instruction indicating that the precautionary
statement may be omitted if storage temperatures are included on the
label. The agency noted that the proposed revision would not materially
change the information that is presented on the label and is consistent
with Rev. 7 (Document ID 0060, pp. 318-320, 330-332).
For self-heating substances and mixtures (C.4.24), a combined
precautionary statement included in the 2012 HCS instructed the user to
keep cool and protect from sunlight. OSHA proposed that a conditional
instruction be added to indicate that ``Keep cool'' can be omitted
where storage temperatures are listed on the label. Because ``Protect
from sunlight'' still needs to be included if specific storage
temperatures are listed on the label, OSHA proposed to delete the
combined statement under the prevention column, and to list only ``Keep
cool'' (and the new conditional instruction) in that column. The
statement: ``Protect from sunlight'' would be moved to the storage
column, similar to the way this is handled for other hazard classes.
OSHA reasoned that these proposed changes would provide the label
preparer better instructions and would provide the appropriate level of
information on the label without repetition. OSHA noted that the
proposed changes would also align with Rev. 7 (Document ID 0060, p.
323). OSHA received no comments on these proposed revisions. Therefore,
the agency is finalizing them as proposed.
16. Do Not Allow Contact With
OSHA proposed to add the conditional note ``if emphasis of the
hazard statement is deemed necessary'' to precautionary statements
indicating that contact is not to be allowed with air (for proposed
Category 1A, pyrophoric gases (C.4.15), pyrophoric liquids (C.4.22),
and pyrophoric solids (C.4.23)) or water (for substances and mixtures
which, in contact with water, emit flammable gases (C.4.25, categories
1 and 2)). Because the hazard phrases, which are also included on
labels for these categories, already warn about the hazards of these
respective chemicals when they contact air or water, OSHA reasoned that
adding this precautionary statement as well could be repetitive.
However, depending on the specific chemical, the label preparer may
feel that added emphasis is warranted. OSHA noted that these proposed
changes would align with Rev. 7 (Document ID 0060, p. 280). OSHA
received no comments on these proposed revisions. Therefore, the agency
is finalizing them as proposed.
17. Handle and Store Contents Under Inert Gas
For substances and mixtures which, in contact with water, emit
flammable gases (C.4.25, all categories), OSHA proposed changing the
precautionary statement ``Handle under inert gas. Protect from
moisture'' to ``Handle and store contents under inert gas/. . . Protect
from moisture'' to clarify that these substances should always be under
inert atmospheres. In addition, OSHA proposed to add conditional
instructions to indicate that if the substance or mixture reacts
readily with moisture in air, then the chemical manufacturer, importer
or distributer must also specify the appropriate liquid or gas if inert
gas is not appropriate. As explained in the NPRM, OSHA anticipated the
new statement would provide greater clarity and is needed because inert
gas is not appropriate in some cases (e.g., white phosphorus should be
handled and stored under water) (86 FR 9717). The agency noted that
this proposed change is also consistent with Rev. 7 (Document ID 0060,
pp. 324-325).
OSHA also proposed to add the statement ``Handle and store contents
under inert gas/. . . '' to pyrophoric liquids (C.4.22) and pyrophoric
solids (C.4.23) and a conditional statement would note that the
manufacturer, importer, or distributor is to specify the appropriate
liquid or gas if inert gas is not appropriate. As explained in the
NPRM, pyrophoric chemicals, by definition, are likely to ignite when in
contact with air. Both C.4.22 and C.4.23 of the 2012 HCS contained the
following statement in the storage column: ``Store contents under . . .
Chemical manufacturer, importer, or distributor to specify appropriate
liquid or inert gas.'' In light of the language OSHA proposed to
include in the prevention column, OSHA proposed to delete this language
from the storage column. OSHA reasoned that the language it proposed
for the prevention column would emphasize that pyrophoric chemicals
must be handled, as well as stored, under inert atmospheres. OSHA noted
that the statements it proposed to add to the prevention column for
C.4.22 (pyrophoric liquids) and C.4.23 (pyrophoric solids) regarding
handling and storing contents under inert gas were included in Table
A3.2.2 of Rev. 7 but were inadvertently left off of tables in Annex 3,
Section 3 for both pyrophoric liquids and pyrophoric solids (Document
ID 0060, p. 281). OSHA received no comments on these proposed
revisions. Therefore, the agency is finalizing them as proposed.
18. Wear Fire Resistant or Flame Retardant Clothing
Category 1 oxidizing liquids (C.4.26) and Category 1 oxidizing
solids (C.4.27) of the 2012 HCS had the precautionary statement ``Wear
fire/flame resistant/retardant clothing.'' That statement was intended
to alert the users of the chemical that they should wear either fire
resistant or flame retardant clothing, not for the label preparer to
choose between the terms ``fire'' and ``flame'' or ``resistant'' and
``retardant''. Therefore, OSHA proposed to replace the 2012 HCS
statement with ``Wear fire resistant or flame retardant clothing'' in
order clarify OSHA's intent. The agency also noted that the proposed
change is consistent with Rev. 7 (Document ID 0060, p. 285). OSHA
received no comments on these proposed revisions. Therefore, the agency
is finalizing them as proposed.
19. Changes in Response Column
Several of the revisions OSHA proposed for the response column are
simply editorial changes intended to improve clarity, correct simple
omissions of a word or phrase, or more efficiently and concisely
combine different precautionary statements. For
example, OSHA proposed to add the phrase ``If on skin'' to the
statement ``Brush off loose particles from skin'' (see C.4.23
(pyrophoric solids) and hazard categories 1 and 2 in C.4.25 (substances
and mixtures which, in contact with water, emit flammable gasses))
because those statements are always combined in Rev. 7 (Document ID
0060, pp. 293-294), and the additional phrase would add clarity. In a
number of cases, OSHA proposed to reorganize the precautionary
statements and to remove redundant wording to improve clarity. For
example, in C.4.14, instead of listing the individual statements and
providing conditions of use, OSHA proposed to list the statements
grouped together (except for materials for Division 1.4S, which have
another set of statements as explained below).
The following discussion does not address changes that are simply
editorial in nature (although, as discussed above, OSHA will make
available a redline version of Appendix C on OSHA's website (https://www.osha.gov/dsg/hazcom). The discussion below highlights substantive
changes to the response column in Appendix C.
20. Rinse Skin With Water [or Shower]
The HCS 2012 precautionary statements for Categories 1A to 1C of
skin corrosion/irritation (C.4.4) and Categories 1 to 3 of flammable
liquids (C.4.19) indicated that if the chemical is on hair or skin, the
affected individual is to immediately take off all contaminated
clothing and rinse skin with ``water/shower.'' OSHA proposed to revise
the statement to instruct the affected individual to rinse skin with
``water [or shower],'' and to add a conditional note indicating that
the text in square brackets is to be used where the chemical
manufacturer, importer or distributor considers it appropriate for the
specific chemical. OSHA reasoned that a deluge shower might be most
appropriate for the chemical, and the use of the square brackets allows
for selection of the most appropriate wording. OSHA also noted that the
proposed change would align with Rev. 7 (Document ID 0060, p. 289).
OSHA received no comments on this proposed revision. Therefore, the
agency is finalizing it as proposed.
21. Get Medical Advice/Attention
In the 2012 HCS, a number of health hazards (i.e., skin corrosion/
irritation (Category 2 in C.4.4), eye damage/irritation (Categories 2A
and 2B in C.4.5), sensitization--skin (C.4.7), germ cell mutagenicity
(C.4.8), carcinogenicity (C.4.9), reproductive toxicity (C.4.10),
specific target organ toxicity--repeated exposure (C.4.12), and
refrigerated liquefied gases (C.4.18)) had combined precautionary
statements that included the statement ``get medical advice/
attention.'' OSHA proposed to add an instruction indicating that the
chemical manufacturer, importer, or distributer is to select medical
advice or attention as appropriate in order to alert label preparers
that they should provide more specific instruction on the type of
medical assistance needed based on the chemical hazard and to align
with Rev. 7 (Document ID 0060, p. 287).
ACC disagreed with the mandatory addition of the requirement to
choose between medical advice or medical attention, stating that it
would provide no added benefit to those handling the chemical and that
it would be costly for companies required to modify the statement
(Document ID 0347, pp. 19-20).
OSHA disagrees with ACC's assertion that a requirement to select
medical advice or attention would not benefit those handling the
chemical. Getting medical attention in response to a toxic exposure
indicates that in-person evaluation is required, while getting medical
advice indicates that consultation may take place by remote means.
There may be situations in which it is always more appropriate for an
exposed worker to seek in-person evaluation and therefore clarifying
between attention and advice is substantively different and conveys
important information to workers. OSHA also finds this is not an overly
burdensome requirement, given the importance of specifying whether
medical attention or medical advice is required following exposure.
OSHA also notes that Rev. 8 has replaced all medical precautionary
statements that included ``advice/attention'' with statements that
provide more detailed instructions. As was discussed above, OSHA is
aligning with Rev. 7 in this and most other updates to the HCS, but
will allow the use of precautionary statements included in Rev. 8. OSHA
is therefore finalizing this revision as proposed.
22. If Inhaled: Remove Person to Fresh Air and Keep Comfortable for
Breathing
A precautionary statement used for sensitization--respiratory
(C.4.6) in the 2012 HCS stated ``If inhaled: If breathing is difficult,
remove person to fresh air and keep comfortable for breathing.'' OSHA
proposed to remove the phrase ``if breathing is difficult,'' reasoning
that including two conditions, ``if inhaled'' and ``if breathing is
difficult,'' is confusing and unnecessary. OSHA also noted that
removing the phrase would make the precautionary statement consistent
with the statement as it appears in other hazard classes in Appendix
C.4, such as acute toxicity--inhalation (C.4.3) and would be consistent
with Rev. 7 (Document ID 0060, p. 353). OSHA received no comments on
this proposed revision. Therefore, the agency is finalizing it as
proposed.
23. Take Off Contaminated Clothing and Wash It Before Reuse
A precautionary statement for skin sensitization (C.4.7) in the
2012 HCS said to wash contaminated clothing before reuse. OSHA proposed
to add the phrase ``Take off contaminated clothing and'' to this
precautionary statement. As explained in the NPRM, the phrase was
inadvertently omitted for skin sensitization in Rev. 3 (Document ID
0085, Att. 7), and therefore in the updates to the HCS in 2012 as well,
but it has since been added to Rev. 7 (Document ID 0060, p. 293). OSHA
received no comments on this proposed revision. Therefore, the agency
is finalizing it as proposed.
24. If Exposed or Concerned
For specific target organ toxicity (single exposure) (C.4.11), OSHA
proposed to revise a precautionary statement indicating ``If exposed''
to ``If exposed or concerned.'' OSHA reasoned that the revision, which
would be consistent with language already used for the germ cell
mutagenicity (C.4.8), carcinogenicity (C.4.9), and reproductive
toxicity (C.4.10) hazard classes, would maintain consistency throughout
C.4 and with Rev. 7 (Document ID 0060, p. 360). OSHA received no
comments on this proposed revision. Therefore, the agency is finalizing
it as proposed.
V. Division 1.4 Explosives (C.4.14) Precautionary Statements
For Division 1.4 explosives, the HCS provides fire-fighting
precautionary statements and instructions on when to apply them
(C.4.14). OSHA proposed two changes to these statements. First, OSHA
proposed to change the instructional note from ``except if explosives
are 1.4S ammunition and components thereof'' to ``except for explosives
of division 1.4 (compatibility group S) in transport packaging'' to
provide clarity about when the note applies; there is no intended
change in meaning. Second, OSHA proposed to revise the precautionary
statement ``Fight fire with normal precautions
from a reasonable distance'' to the statement ``Fight fire remotely due
to the risk of explosion.'' OSHA reasoned that the proposed new
statement would be more appropriate and protective because it specifies
the explosion risk due to fire associated with Division 1.4
(Compatibility Group S) explosives. OSHA also noted that these proposed
changes would align with Rev. 7 (Document ID 0060, p. 306). OSHA
received no comments on these revisions, and is therefore finalizing
them as proposed.
Toby Threet commented that OSHA should revise another precautionary
statement which appears in C.4.14 as well as other categories: ``Do NOT
fight fire when fire reaches explosives.'' According to Threet, this
statement ``implies that it is OK to fight the fire until almost the
very moment when the fire reaches the explosives . . . Fire . . . can
ignite things, even if the fire (i.e., the flame) has not `reached'
them yet.'' Threet suggested ``Stop fighting fire before it nears
explosives'' and ``Leave the area before fire nears explosives'' as
alternatives to the existing language (Document ID 0279, p. 23-24).
OSHA notes that the existing precautionary statement was adopted
from the GHS in 2012 and OSHA did not propose to modify it in the NPRM.
Threet's suggestion to change it is therefore outside the scope of this
rulemaking. Furthermore, updates to the GHS have not changed this
precautionary statement (Document ID 0060, p. 306) and OSHA is not
aware of any confusion regarding the meaning of this statement or any
incidents where misinterpretation of this statement has caused harm to
workers. OSHA therefore has not accepted Threet's recommendation.
(A) Eliminate All Ignition Sources, if Safe To Do So
For flammable gases (C.4.15), a precautionary statement in the 2012
HCS instructed the user to ``Eliminate all ignition sources if safe to
do so.'' OSHA proposed to revise the statement to ``In case of leakage,
eliminate all ignition sources'' by adding the phrase ``in case of
leakage'' to stress the dangers of flammable gas leaks, even where the
leaking gas is not yet burning, because the leak could create an
explosive atmosphere; and by deleting the term ``if safe to do so''
because it could discourage quick action. OSHA reasoned that
eliminating gas leaks or ignition sources would not be expected where a
fire would hinder that action. OSHA also proposed to add this statement
to all of the new flammable gas categories it proposed in the NPRM.
OSHA noted that these proposed changes would be consistent with Rev. 7
(Document ID 0060, pp. 307-309).
Toby Threet commented regarding the precautionary statement ``In
case of leakage, eliminate all ignition sources'' that eliminating
ignition sources may require a person to enter a hazardous area and
suggested that the statement should be ``In case of leakage, eliminate
all ignition sources if safe to do so'' (Document ID 0279, p. 24).
As discussed above, OSHA proposed to delete the phrase ``if safe to
do so'' because it could discourage quick action. OSHA believes that
removing the phrase ``if safe to do so'' will not cause workers to
enter a hazardous area in order to eliminate ignition sources. OSHA
believes that workers will have training on the safe use and handling
of chemicals under OSHA regulations such as the HCS, as well as the
requirement under the PSM standard to implement an emergency action
plan, which must include procedures for handling small releases (29 CFR
1910.119(n)). Additionally, OSHA's regulations for hazardous waste
operations and emergency response ensure that workers will be made
aware of dangers related to gas leaks and the work practices that will
minimize risks from these hazards (see 29 CFR 1910.120 and 1926.65).
OSHA concludes that these additional regulatory requirements will
ensure that employees do not place themselves in harm's way in the
event of a gas leak, particularly where there is a source of ignition
present. Therefore, OSHA has not included ``if safe to do so'' in the
precautionary statement.
For the reasons discussed above, OSHA is finalizing the changes to
the precautionary statement regarding eliminating ignition sources in
case of flammable gas leaks as proposed.
(B) Type A and B Self-Reactive Substances and Mixtures (C.4.21)
For Type A self-reactive substances and mixtures (C.4.21), OSHA
proposed to delete the precautionary statements ``In case of fire use .
. . to extinguish'' (along with its explanatory note) and ``Fight fire
remotely due to the risk of explosion.'' In place of the statements
OSHA proposed to delete, OSHA proposed to add the statement ``In case
of fire: Explosion risk. Evacuate area. DO NOT fight fire when fire
reaches explosives.'' OSHA explained that it proposed these changes
because it is dangerous to fight a fire involving this type of material
so individuals should always be advised against it, and noted that
these changes would align with Rev. 7 (Document ID 0060, p. 318).
For Type B self-reactive substances and mixtures (C.4.21), OSHA
proposed to combine existing precautionary statements and to delete
duplicate phrases that would occur with the new combination. As noted
in the NPRM, OSHA did not intend these changes to alter the meaning of
the statements. OSHA proposed to use brackets around the statement
``Use . . . to extinguish'' with a conditional note to indicate that
the text in square brackets is to be included if water increases risk,
in order to preserve the conditions of use with the new combination of
phrases. OSHA noted that these proposed changes would align with Rev. 7
(Document ID 0060, p. 319).
OSHA received no comments on these proposed revisions. Therefore,
the agency is finalizing them as proposed.
(C) Fire and Explosion Hazards for Organic Peroxides (C.4.28)
Precautionary statements and instructions related to fire and
explosion hazards or fire-fighting procedures were not included in Rev.
3 (Document ID 0085, Att. 7, pp. 65-67) or in the 2012 HCS for organic
peroxides (C.4.28). The UNSCEGHS has since adopted these precautionary
statements (Document ID 0060, pp. 330-332). OSHA proposed to adopt the
Rev. 7 precautionary statements in the response column for organic
peroxides as for self-reactive substances and mixtures (C.4.21). OSHA
reasoned that it is appropriate to include these statements for organic
peroxides, as well as for self-reactive substances and mixtures,
because the fire and explosion hazards of the two classes of compounds
are equivalent (Document ID 0095). OSHA received no comments on this
proposed revision. Therefore, the agency is finalizing it as proposed.
(D) Immerse in Cool Water or Wrap in Wet Bandages
For pyrophoric liquids (C.4.22), pyrophoric solids (C.4.23), and
categories 1 and 2 of substances and mixtures which in contact with
water emit flammable gases (C.4.25), a precautionary statement in the
2012 HCS indicated that if the substance is on the skin, the user
should ``immerse in cool water/wrap with wet bandages.'' For pyrophoric
liquids (C.4.22) and solids (C.4.23), OSHA proposed to change the
forward slash to an ``or'' and the ``with'' to ``in'' so that the
statement would read ``Immerse in cool water or wrap in wet bandages''
in order to make clear that the chemical manufacturer, importer, or
distributer is not to choose one action or the other but is to include
both actions on the label. In the case of
substances and mixtures which, in contact with water, emit flammable
gases (C.4.25), OSHA proposed to delete ``/wrap in wet bandages'' from
the statement so that the complete statement reads ``Brush off loose
particles from skin and immerse in cool water.'' OSHA reasoned that,
for these chemicals, a large volume of water is needed and wrapping in
wet bandages is not enough to address problems caused by the heat of
the reaction. OSHA also noted that the proposed changes would align
with Rev. 7 (Document ID 0060, p. 324). OSHA received no comments on
these proposed revisions. Therefore, the agency is finalizing them as
proposed.
(E) Changes in Storage Column
1. Store Separately
For self-reactive substances and mixtures (C.4.21), self-heating
substances and mixtures (C.4.24), and organic peroxides (C.4.28), OSHA
proposed to revise the precautionary statement ``Store away from other
materials'' to ``Store separately.'' OSHA reasoned that the revised
statement is preferable because it is shorter and more appropriate.
OSHA also proposed to add the ``Store separately'' precautionary
statement to Category 1 oxidizing liquids (C.4.26) and Category 1
oxidizing solids (C.4.27) because those chemicals are not compatible
with other chemicals and thus must be stored separately. OSHA noted
that these proposed changes are consistent with Rev. 7 (Document ID
0060, p. 297). OSHA received no comments on these proposed revisions.
Therefore, the agency is finalizing them as proposed.
2. Store Contents Under . . .
OSHA proposed to delete a precautionary statement that says ``Store
contents under . . . '' and an instructional note that the chemical
manufacturer, importer, or distributer is to specify the appropriate
liquid or inert gas which were previously in pyrophoric liquids
(C.4.22) and solids (C.4.23). The UNSCEGHS recommended that the
statement be deleted from the storage column because it adopted the
statement ``Handle and store contents under inert gas/ . . . , '' along
with a similar instructional note, in the prevention column (Document
ID 0152, p. 46). OSHA reasoned that placing the statement in the
prevention column would be more appropriate, as there it would warn the
downstream user that pyrophoric chemicals must be under inert gas not
only during storage but at all times, including during processing and
use. OSHA received no comments on this proposed revision. Therefore,
the agency is finalizing it as proposed.
3. Maintain Air Gap Between Stacks or Pallets
For self-heating substances and mixtures (C.4.24), OSHA proposed to
revise the precautionary statement that currently says ``Maintain air
gap between stacks/pallets'' so it reads instead ``Maintain air gap
between stacks or pallets'' in order to clarify that chemical label
preparers are not to choose between ``stacks'' or ``pallets'' but are
to include both words on the label. OSHA noted that this proposed
change would align with Rev. 7 (Document ID 0060, p. 323). OSHA
received no comments on this proposed revision. Therefore, the agency
is finalizing it as proposed.
4. Store in Corrosion Resistant/ . . . Container With a Resistant Inner
Liner
A precautionary statement for the corrosive to metals (C.4.29)
class in the 2012 HCS said to store in a ``corrosive resistant/ . . .
container with a resistant inner liner.'' OSHA proposed to change the
word ``corrosive'' to ``corrosion'' because it is the technically
correct term. In addition, OSHA proposed to insert a new conditional
instruction to indicate that the precautionary statement may be omitted
if the statement ``Keep only in original packaging'' is included on the
label. OSHA reasoned that this would eliminate the redundancy of
including both statements. OSHA noted that these proposed changes would
align with Rev. 7 (Document ID 0060, p. 333). OSHA received no comments
on this proposed revision. Therefore, the agency is finalizing it as
proposed.
(F) Additional Instructional Notes
For acute toxicity--inhalation (C.4.3) (category 1-3) and specific
organ toxicity (single exposure, category 3) (C.4.11), OSHA proposed
minor, non-substantive edits to the conditional instruction for
precautionary statements about keeping the container tightly closed and
storing in a well-ventilated place. OSHA proposed to revise the note
from ``if product is volatile so as to generate hazardous atmosphere''
to ``if the chemical is volatile and may generate a hazardous
atmosphere.'' The agency intended these edits is to improve clarity and
make the instruction more consistent with a newly added instruction for
flammable liquids (C.4.19). OSHA noted that this proposed change would
be consistent with Rev. 7 (Document ID 0060, p. 281).
For flammable liquids (C.4.19), OSHA proposed to add a clarifying
instruction indicating that the precautionary statement ``Store in a
well-ventilated place. Keep cool'' applies to flammable liquids in
Category 1 and other flammable liquids that are volatile and may
generate an explosive atmosphere. However, for Category 4 flammable
liquids, OSHA proposed to delete ``Keep cool,'' because these liquids
are less volatile and have a flashpoint above 60[deg] C and therefore
are unlikely to generate a hazardous concentration of vapor during
storage. OSHA stated in the NPRM its preliminary finding that the
precautionary statement ``Store in a well ventilated place'' would
provide the appropriate level of protection, and noted that these
proposed changes would align with Rev. 7 (Document ID 0060, pp. 315-
316).
For explosives (C.4.14), OSHA proposed minor edits to precautionary
statements and instructions for storing in accordance with local/
regional/national/international regulations to clarify that the
chemical manufacturer, importer, or distributer is to specify the
contents of the applicable regulations. OSHA noted that these proposed
changes would be consistent with Rev. 7 (Document ID 0060, p. 295). APA
expressed concern that this would require responsible parties to list
regulations regarding the storage of explosives from every country,
district, region, and municipality in the world, and that ``Shipping
internationally would not only become a nightmare for the manufacturer/
creator of the SDS but impossible.'' They also asked that OSHA consider
allowing manufacturers to just list the storage information for the
country of origin of the manufacturer instead, along with a statement
that customers should consult their local regulations (Document ID
0337, pp. 3-4).
OSHA does not believe the proposed requirements are as burdensome
as the APA suggests. First, although APA framed this as an issue
regarding the SDS, the disposal requirements they point to in Appendix
C are only required on labels. OSHA is not suggesting that label
preparers need to address any regulations outside of the United States
and thus the breadth of what is required is much narrower than what APA
suggested. The agency has provided guidance indicating that when
chemicals are prepared for direct shipment to a destination outside of
the U.S. and are placed inside of a DOT or other similarly-approved
shipping container, the manufacturer can label the sealed containers
for the destination
country (HCS labeling of imports and exports, 2015, available at
https://www.osha.gov/laws-regs/standardinterpretations/2015-09-10).
Additionally, OSHA is not suggesting that the label preparer needs to
include every state, local, or federal regulation. Rather, they must
include the content of the storage requirements, and since explosives
are heavily regulated, for instance under OSHA 29 CFR 1910.109 as well
as ATF 27 CFR 555 subpart K, OSHA does not anticipate that storage
requirements will vary widely across states and localities in the
United States, so label preparers may only need to include federal
requirements or a few additional state or local requirements in
addition to the federal requirements. OSHA also believes that producers
of highly hazardous materials, such as explosives, already have
programs in place to instruct their customers on how to safely ship,
use, store and dispose of explosives in the United States, and
therefore can readily identify state and local storage regulations that
may differ from federal regulations. For these reasons, OSHA declines
to accept APA's alternative suggestion for this language.
The 2012 HCS Appendix C sections on aerosols (C.4.16), self-
reactive substances (C.4.21), self-heating substances and mixtures
(C.4.24), and organic peroxides (C.4.28) included precautionary
statements addressing storage temperatures not to be exceeded, with
temperatures listed in degrees Celsius/Fahrenheit. The GHS added an
instruction that the chemical manufacturer should use the applicable
temperature scale for the region they are supplying (Document ID 0060,
p. 297). In other OSHA standards, the primary temperature scale used is
Fahrenheit. Therefore, OSHA proposed to require only the Fahrenheit
scale in the precautionary statements, but to allow the chemical
manufacturer, importer or distributor to include the temperature in
Celsius (as noted by the parentheses ``( )'' around [deg]C) in addition
to the required temperature in Fahrenheit.
In addition, for self-reactive substances and mixtures (C.4.21) and
organic peroxides (C.4.28), OSHA proposed to add conditional
instructions to two precautionary statements. The first conditional
instruction was proposed to clarify that the statement to store in a
well-ventilated place should not be used for temperature controlled
self-reactive substances and mixtures or organic peroxides because
condensation and consequent freezing may occur. The second was proposed
to clarify that a storage temperature is only needed if temperature
control is required or deemed necessary. OSHA noted that these proposed
changes would align with Rev. 7 (Document ID 0060, pp. 295, 297).
OSHA received no comments on these proposed revisions, other than
the comment on storage of explosives. Therefore, the agency is
finalizing them as proposed.
VI. Changes in Disposal Column
For most of the health and physical hazards addressed by Appendix
C, the HCS includes a precautionary statement to dispose of contents/
container in accordance with local/regional/national/international
regulations (to be specified). OSHA proposed to add an instructional
note in all relevant places in the appendix indicating that the
chemical manufacturer, importer, or distributor is to specify whether
the disposal requirements apply to the contents, the container, or
both. OSHA noted that this proposed change would align with Rev. 7
(Document ID 0060, pp. 298-299).
ACC disagreed with the proposed instructional note to the disposal
precautionary statement. They urged OSHA ``to retain flexibility,''
noting that some of their members' use disposal precautionary
statements that are more general and asserting that there is ``no added
benefit to whomever is handling the chemical by specifying if the
phrase applies to the contents and/or container'' (Document ID 0347, p.
19). OSHA disagrees. Workers need to know whether they need to exercise
the same level of caution when disposing of the contents and the
container. Without such specificity, workers confront ambiguous
messaging that may put them at greater risk if they do not understand
what is intended. The agency is therefore finalizing this change as
proposed.
OSHA also proposed to revise the precautionary note for disposal of
explosives (C.4.14). The 2012 HCS tables for explosives (C.4.14),
except for hazard category division 1.6, included a precautionary
statement to dispose of contents/container in accordance with local/
regional/national/international regulations (to be specified). However,
as explained in the NPRM, this precautionary statement may not give
users the information needed to safely dispose of explosives,
particularly malfunctioning, expired, or non-used explosives where
special care is needed. OSHA found this issue to be of particular
concern for explosives such as fireworks, signal flares, and
ammunition. Poorly formulated advice on the label may lead to the
disposal of such explosive waste in a way that poses a risk to the
workers that handle the waste (Document ID 0156). Therefore, OSHA
proposed to change the precautionary note for explosives (C.4.14) to
read: ``Refer to manufacturer, importer, or distributor . . . for
information on disposal, recovery, or recycling'' and to add an
instructional note to indicate that the chemical manufacturer,
importer, or distributor is to specify the appropriate source of
information, in accordance with local/regional/national/international
regulations as applicable. OSHA proposed this change to address the
recycling or recovery of unexploded fireworks or other unused explosive
cartridges and signal flares, which can result in unsafe conditions and
should only be performed by specialists. OSHA noted that this proposed
change is consistent with Rev. 7 (Document ID 0060, p. 299).
APA raised the same concerns with regards to OSHA's proposed
revision to the disposal precautionary note for explosives as it did on
the storage precautionary statement and also suggested that
manufacturers should instead provide information for storage and
disposal for the country where the manufacturer is located and then
alert customers and recipients of the products on the SDS to consult
local regulations for proper storage and disposal (Document ID 0337,
pp. 3-4).
OSHA disagrees that this proposal creates a new, unwieldy burden
for manufacturers. The intent of this language was to clarify
requirements, not create a new one. Label preparers were already
required to provide this information in the disposal column, and OSHA
is not aware of any concerns raised by other regulated parties
regarding this requirement or its feasibility. Therefore, OSHA
disagrees with APA's suggested revision, which the agency believes
would put undue burden on the downstream users and could be confusing
to them, and is finalizing the changes to the disposal column for
explosives as proposed.
(A) GHS Revisions That OSHA Is Not Adopting
Rev. 7 includes a small number of revisions that OSHA did not
propose to adopt for this update to Appendix C. In general, OSHA did
not propose to adopt any statements or conditional instructions that
address consumer products because the HCS does not cover communication
of hazards to consumers. This section discusses other specific
provisions in Rev. 7 (Document ID 0060) that OSHA did not propose to
adopt.
In the HCS, a number of tables for inhalation hazards in Appendix
C.4 (i.e., acute toxicity--inhalation (C.4.3, Categories 3 and 4),
respiratory sensitization (C.4.6), skin sensitization (C.4.7), and
specific target organ toxicity--single exposure (C.4.11, Category 3))
contain a precautionary statement that says ``Avoid breathing dust/
fume/gas/mist/vapors/spray.'' A conditional note in Rev. 7 (Document ID
0060, p. 283) indicates that this precautionary statement is not needed
where the precautionary statement ``Do not breathe dust/mist/fume/gas/
vapors/spray'' is included on the label. Also, for skin corrosion/
irritation (C.4.4, Category 2), Rev. 7 contains a conditional note
indicating that the statement ``If skin irritation occurs: Get medical
advice/attention'' may be omitted if the statement ``If skin irritation
or rash occurs: Get medical advice or treatment'' is used (Document ID
0060, p. 292). OSHA did not propose to adopt these conditional
instructions because it believes that the rules in C.2.4 regarding
precautionary statement text provide the necessary flexibility. The
agency received no comments on its decision not to include these
conditional instructions in the HCS.
In Rev. 7, the precautionary statements used in flammable liquids
(C.4.19) and flammable solids (C.4.20) about explosion-proof equipment
and taking action to prevent static discharge include a conditional
instruction indicating that these precautionary statements can be
omitted if national or local legislation contains provisions that are
more specific (Document ID 0060, p. 282). OSHA did not propose to adopt
this instruction because the agency believes these precautionary
statements contain important information that should always be included
on labels. Although some OSHA and consensus standards address the use
of explosion-proof equipment and preventing static discharge for
flammable liquids or solids, they do not address hazard communication.
Therefore, OSHA does not believe they are specific enough to justify
omitting the relevant precautionary statement from labels. Label
preparers can add more specific supplementary information from
standards as long as it complies with paragraph C.3. For example, they
may reference OSHA's flammable liquids standard (29 CFR 1910.106),
which addresses the requirements for electrical equipment in workplaces
that store or handle flammable liquids. OSHA received no comments on
its preliminary decision not to include this conditional instruction in
the HCS.
Under the HCS, a precautionary statement for gases under pressure
(C.4.18) currently says ``Protect from sunlight.'' Rev. 7 contains a
conditional instruction indicating that this precautionary statement
``may be omitted for gases filled in transportable gas cylinders in
accordance with packing instruction P200 of the UN Recommendations on
the Transport of Dangerous Goods, Model Regulations, unless those gases
are subject to (slow) decomposition or polymerization, or the competent
authority provides otherwise'' (Document ID 0060, p. 313). These
special packaging instructions are not applicable to cylinders used in
the United States; therefore, OSHA did not propose to add this
conditional instruction to C.4.18. OSHA received no comments on its
preliminary decision not to include this conditional instruction in the
HCS. OSHA has therefore decided not to include these revisions.
F. Appendix D
Appendix D provides specific requirements for what information
chemical manufacturers, distributors, importers, and employers must
provide on the SDS, including rules regarding specific headings, sub-
headings, and information to be contained under each subheading. The
information specified as mandatory in Appendix D is the minimum
required information on the SDS, however, an SDS may include additional
information as long as it does not contradict or undermine the required
SDS elements.
In the NPRM, OSHA proposed several changes in Appendix D to align
with Rev. 7, clarify existing requirements about which stakeholders
have expressed confusion, and ensure consistency with updated
scientific principles (86 FR 9576; Document ID 0060, pp. 377-399).
I. Introductory Text
In the introductory section of Appendix D, OSHA proposed to add a
sentence stating that ``[w]hile each section of the SDS must contain
all of the specified information, preparers of safety data sheets are
not required to present the information in any particular order within
each section.'' OSHA proposed this change to clarify the existing text.
As the information within each section can be listed in any order, OSHA
noted that it did not anticipate any increased burden on SDS preparers
from this change.
API commented that the proposed revision could be helpful,
especially in light of other changes OSHA proposed regarding the
presentation of physical and chemical properties elsewhere on the SDS
(Document ID 0316, p. 27). Similarly, Michele Sullivan supported the
proposal and commented that the proposed clarification would provide
flexibility (Document ID 0366, p. 8). OSHA received no comments
objecting to the proposed clarification, and is therefore finalizing
the addition of the proposed sentence to the introductory paragraph of
Appendix D.
II. Section 1: Identification
Section 1 of Table D.1 requires SDS preparers to provide
identifying information. In the NPRM, OSHA proposed to clarify that the
address and telephone number of the chemical manufacturer, importer, or
other responsible party which the HCS requires must be United States
domestic.
API and NAIMA supported the proposed revision (Document ID 0316, p.
27; 0338, p. 9; 0366, p. 8). Michele Sullivan also supported it, and
stated that it would be helpful to clarify that the address and phone
number provided in the SDS must be in the United States since there has
been confusion about this in the past (Document ID 0366, p. 8).
ACC sought clarification on how this revision would impact foreign
suppliers and inquired what the options would be for a foreign supplier
who ships products into the United States to comply with this
provision. In addition, ACC recommended that OSHA make this requirement
non-mandatory ``due to length and complexity of the chemicals supply
chain'' (Document ID 0347, p. 21). NACD commented that the proposed
revision would present challenges for foreign suppliers who are not
willing to have U.S. addresses and phone numbers, which would in turn
require importers to generate a new SDS with their own U.S. address and
phone number and assume the liability for all the information in the
SDS. However, NACD also pointed out that having a U.S. address and
phone number on the SDS would be consistent with labeling requirements
specified in Appendix C and could help demonstrate to foreign suppliers
and importers that this is required (Document ID 0329, pp. 7-8).
OSHA disagrees that the proposed language would impose new burdens
on either foreign suppliers or domestic importers. As OSHA discussed in
the NPRM, a U.S. telephone number and U.S. address were already
required on the SDS based on the previously existing requirements of
Appendix D, which requires that the name, address, and telephone number
of the responsible party, such as the chemical manufacturer or
importer, be listed on
the SDS (86 FR 9722). OSHA explained in a 2016 LOI that when chemicals
are imported into the United States, the importer (defined by the HCS
as being the first business with employees in the United States to
receive hazardous chemicals produced in other countries for
distribution in the United States) is the responsible party for
purposes of compliance with the HCS and is required to use a U.S.
address and U.S. phone number on the SDS (Document ID 0090).
Therefore, in response to ACC's question and NACD's concern
regarding foreign suppliers, OSHA notes that foreign companies that
ship products to importers in the United States are not required to
maintain U.S. contact information or to include their address and
telephone number on the SDS. Furthermore, NACD's comment that importers
must include their own U.S. address and phone number on the SDS and
must assume responsibility for information in the SDS is correct, but
is not a new burden associated with OSHA's proposed change.
OSHA believes it is important to codify the requirement for a U.S.
telephone number and U.S. address in Section 1 of Table D.1 in the text
of the HCS to minimize any further confusion. This change would clarify
the existing requirement, which--as comments received by the agency
demonstrate--continues to be a point of confusion in cases where
hazardous chemicals are imported to the United States. ACC's request to
make the inclusion of a U.S. phone number and address non-mandatory
would conflict with the pre-existing requirement as explained in the
2016 interpretation discussed above, adding to rather than mitigating
stakeholder confusion. OSHA is therefore finalizing the proposed
revision to clarify that the address and telephone number of the
chemical manufacturer, importer, or other responsible party which the
HCS requires in Section 1 of the SDS must be United States domestic.
III. Section 2: Hazard(s) Identification
In Section 2, Hazard(s) identification, OSHA proposed to clarify
where and how chemical hazard information should be presented. First,
OSHA proposed to clarify that Section 2 (a) must include any hazards
associated with a change in the chemical's physical form under normal
conditions of use. OSHA also proposed a new Section 2 (c) to clarify
that hazards identified under normal conditions of use that result from
a chemical reaction (changing the chemical structure of the original
substance or mixture) needed to be included. To accommodate the new
proposed Section 2 (c), OSHA proposed to move existing Section 2 (c)
and (d) to Section 2 (d) and (e).
As OSHA noted in the NPRM, the proposed revisions to Section 2
would require hazards associated with chemicals as shipped, as well as
hazards associated with a change in the chemical's physical form under
normal conditions of use, to be presented in Section 2 (a), and new
hazards created by a chemical reaction under normal conditions of use
to be presented in Section 2 (c). OSHA believed this would sufficiently
differentiate the different types of hazards presented under normal
conditions of use. OSHA sought stakeholder comments on this issue.
After reviewing stakeholders' comments pertaining to proposed
changes in paragraph (d)(1), OSHA made significant changes to proposed
paragraph (d) and made related changes to proposed Appendix D
requirements for Table D.1 Section 2 of the SDS. As previously
described in the Summary and Explanation for paragraph (d)(1), OSHA
removed the terms ``under normal conditions of use and foreseeable
emergencies'' from paragraph (d)(1). In the final rule, paragraph
(d)(1) has two subparagraphs, indicating that hazard classification
must include hazards associated with the chemical's intrinsic
properties including: (i) a change in the chemical's physical form and;
(ii) chemical reaction products associated with known or reasonably
anticipated uses or applications.
To align with these changes to paragraph (d)(1), in Section 2 (a),
OSHA replaced its original proposed language with ``in accordance with
paragraph (d)(1)(i) of Sec. 1910.1200.'' OSHA also removed the
proposed language from Section 2 (c) and replaced it with ``Hazards
classified under paragraph (d)(1)(ii) of Sec. 1910.1200.'' The new
language in these two paragraphs clarifies OSHA's intentions and fully
aligns Appendix D with paragraph (d)(1) so that there is no conflict
between those two sections that would create confusion. Further
discussion of the scope of these requirements and comments regarding
these changes that were not specific to the language in Section 2 can
be found in the Summary and Explanation for paragraph (d).
OSHA received several comments specific to the proposed changes to
Section 2 of Table D.1. NIOSH and Ameren supported the proposed changes
(Document ID 0281, Att. 2, p. 6; 0309, p. 13). ACC commented that the
proposed change to paragraph (d)(1) used the words ``hazard
classification shall include . . .'', but the original proposed Section
2 (c) in Table D.1 only said ``Hazards identified under normal
conditions of use. . . .'', without referring to classification. ACC
found the proposed language unclear as to whether manufacturers and
importers need to classify for reaction hazards, or just mention them
in Section 2 of the SDS (Document ID 0347, p. 21). As noted above, OSHA
is changing Section 2 (c) to begin with ``Hazards classified under
paragraph (d)(1)(ii) . . .'' (emphasis added) to clarify this issue and
better align Section 2 with paragraph (d)(1).
An anonymous commenter asked whether hazardous substances formed by
chemical reactions under normal conditions of use must be disclosed in
Section 3 and/or Section 8 of the SDS (Document ID 0267). For
situations where hazardous substances form during use but the substance
is not present in its hazardous state in the mixture as shipped,
manufacturers are not required to provide this information in Sections
3 or 8 because the resulting hazardous substance is not an ingredient
or constituent. However, as discussed in a 2016 LOI, OSHA expects
manufacturers to include information on substances formed by chemical
reactions in Sections 2 and 10 (available at https://www.osha.gov/laws-regs/standardinterpretations/2016-05-20). OSHA notes that this requires
the inclusion of occupational exposure limits, including PELs and TLVs,
under Section 10 (d): Conditions to Avoid.
The High Temperature Industrial Wool Coalition (HTIW) urged OSHA to
allow hazards from a downstream chemical reaction to be addressed in
Section 16 of the SDS, rather than Section 2, in cases ``where the
nature of the hazard is unclear, and the potential [hazard] is
extremely limited'' (Document ID 0330, p. 3). By way of example, HTIW
explained that glassy refractory ceramic fibers (RCF) do not contain
crystalline silica, but that depending on the duration and temperature
of exposure, fiber chemistry, and/or the presence of fluxing agents or
furnace contaminants, devitrifying RCF may form crystalline silica dust
in amounts which HTIW said were usually undetectable in the furnace
conditions. HTIW stated that they believe the evidence is not
sufficient to list RCF as a hazard in Section 2 of the SDS. They noted
that ``the possibility of hazard is discussed in Section 16, which
addresses other potential issues'' and opined that in this case,
inclusion of after-service RCF in Section 2 of the SDS would
``overemphasize the potential hazard,
potentially fostering misunderstanding of the issue and leading to
unnecessary or inappropriate workplace `corrective' actions'' (Document
ID 0330, pp. 3-5).
OSHA disagrees with HTIW's suggestion and with its conclusion that
the hazard presented by RCF should be excluded from Section 2 because,
as HTIW explained in its example, RCF may form crystalline silica dust
in the process. Section 2 requirements are set to address these very
types of situations. Manufacturers must provide additional information
on toxicity, if known, in Section 11, and may provide additional
information in Section 16. However, any hazard information must be
included in Section 2. Classification is based on the intrinsic
properties of the chemical, not the anticipated level of exposure in
the workplace, except in cases where the chemical is bound in such a
way as to be incapable of resulting in exposure (see OSHA, Feb. 10,
2015, Letter of Interpretation, available at https://www.osha.gov/laws-regs/standardinterpretations/2015-02-10-0). OSHA, therefore, does not
agree that hazards from downstream chemical reactions may be addressed
solely in Section 16 under the circumstances described by HTIW.
Finally, OSHA received a question pertaining to Section 2 (e),
which addresses requirements for stating the percentage of ingredients
of unknown toxicity in a mixture. The anonymous commenter noted that
Appendix A paragraph A.1.3.6.2.3, Appendix C paragraph C.3.3, and
Appendix D of the proposed standard require a statement of the
concentration of ingredients of unknown acute toxicity to appear in
Section 2 of the SDS and on the label. They asked, in the case of a
mixture for which the exact concentration(s) of hazardous component(s)
are withheld as trade secrets and are reported as prescribed
concentration range(s) in Section 3 of the SDS, in accordance with
proposed paragraph (i)(1)(iv), whether it would be permissible to
report the percentage of ingredient(s) of unknown acute toxicity as a
range corresponding to one of the prescribed ranges in Section 2 of the
SDS, or whether the exact percentage of those ingredients must be
reported (Document ID 0266).
Manufacturers are required to state the exact percentage of a
mixture that is composed of ingredients of unknown acute toxicity if
the concentration of at least one such ingredient is >= one percent and
the mixture is not classified based on testing of the mixture as a
whole. In this case, manufacturers are not required to report the
individual concentrations of ingredients with unknown toxicity in
Section 2, but rather the total percentage of unknown toxicity, which
may include multiple chemicals. They may not use the prescribed ranges
included in paragraph (i) for the purpose of reporting the
concentration of unknown acute toxicity. To the extent that this
presents concerns for CBI due to a single chemical having unknown
toxicity, OSHA notes that SDS preparers still have the option to
withhold the name of that chemical.
Based on the comments received, OSHA is finalizing different
language from its proposal in Section 2, as described above, to more
accurately convey its intent and align the text of Section 2 with the
revised regulatory text of paragraph (d)(1).
IV. Section 3: Composition/Information on Ingredients
Section 3 of the SDS contains information on the composition of the
chemical and its ingredients, with specific requirements for substances
and mixtures, as well as for chemicals where a trade secret is claimed.
In the NPRM, OSHA proposed several changes to this section. Under the
subheading For Substances OSHA proposed to add ``(constituents)'' to
paragraph (d) to clarify the term ``additives.'' The intention of this
proposal was to clarify that any individual part of an ``additive''
that contributes to the classification of that material needs to be
listed in Section 3 of the SDS. OSHA received no comments objecting to
the addition of ``(constituents)'' in Section 3 and is therefore
finalizing it as proposed.
OSHA also proposed to revise the information required for mixtures.
Section 3 requires, among other things, the chemical name of each
ingredient in a mixture that is classified as a health hazard. OSHA
proposed requiring the inclusion of the CAS number or other unique
identifier for these ingredients. As noted in the NPRM, CAS numbers are
unique numerical identifiers assigned by the American Chemical Society
(ACS), internationally recognized as being reliable and readily
validated; unique to only one compound, substance or chemical; and a
common link between various nomenclatures that may be used as
descriptors for a substance or compound (86 FR 9722). OSHA believes
that the proposed requirement would provide the downstream user with
important information, since it provides a unique descriptor of the
chemical, whereas the chemical identity may be ambiguous.
PLASTICS and API supported the proposed requirement to include the
CAS number or other unique identifier for ingredients in mixtures
(Document ID 0314, p. 21; 0316, p. 28). ICT commented that CAS numbers
are not assigned to all chemicals and accession numbers exist only for
substances on the confidential TSCA inventory and therefore identifying
numbers may not be available for all chemicals which SDS preparers are
required to disclose in Section 3. ICT suggested that OSHA should allow
manufacturers to use ``not available'' for those chemicals without
identifying numbers (Document ID 0324, p. 6).
OSHA recognizes that a CAS number may not be available for all
chemicals. OSHA notes, however, that the proposal required
manufacturers to provide CAS or other unique identifier numbers for
hazardous ingredients. While OSHA intends that CAS numbers be provided
when available, in cases where a CAS number is not available or is
protected as CBI, another unique identifier must be provided. For
example, an identification number used internally by the manufacturer
(e.g., product number) can be used to identify the ingredient upon
request in emergency and non-emergency situations. Accordingly, OSHA
disagrees with ICT's concern that SDS preparers will be unable to
provide an appropriate unique identifier.
However, ICT's comment does raise the concern that in choosing an
identifier, an SDS preparer might select one for which the source is
not readily apparent. Certain product numbers or other identifiers used
internally by the manufacturer may be of little use when placed on the
SDS without context. Though OSHA proposed to permit the use of ``other
unique identifiers'' for mixtures in Section 3 of the SDS, the agency
wishes to clarify that it would only consider such a number to be an
adequate identifier if it can actually be used by downstream recipients
of the SDS to identify the chemical. Accordingly, OSHA has added a
requirement in the final rule that, where a preparer of an SDS uses a
unique identifier other than a CAS number, they must include the source
of that unique identifier. This will ensure that any unique identifier
functions as such for recipients of the SDS. OSHA is finalizing this
language with the changes described above.
OSHA also proposed a set of changes in Section 3 to reflect the
proposed revision to paragraph (i), Trade secrets, which would allow
companies to withhold concentration ranges as a trade secret. Under the
proposed language in Section 3, when a company withholds the
concentration or concentration range as a trade secret, it must provide
a chemical concentration range in
accordance with the prescribed concentration ranges in paragraph
(i)(1)(iv).
OSHA received a variety of comments about the proposed revisions to
paragraph (i), which the agency addressed in the Summary and
Explanation for paragraph (i). Ameren supported the proposed changes to
Section 3 of the SDS, stating that the changes could allow downstream
manufacturers to more accurately classify their products where the
mixture in question is one of their ingredients (Document ID 0309, p.
13). Toby Threet commented that the language in this section on trade
secrets needed clarification. First, Threet noted that the word ``or''
in the phrase ``. . . the specific chemical identity, exact percentage
(concentration), or concentration range of composition has been
withheld as a trade secret is required . . .'' could imply that a trade
secret may be claimed for only one of these three categories. Threet
suggested that it is possible that both the specific chemical identity
and either the exact concentration or the concentration range may need
to be withheld and therefore an ``and/or'' should be inserted in an
appropriate location in the sentence (Document ID 0279, p. 24).
Toby Threet also commented that in the proposed language, the word
``composition'' normally refers to or includes chemical identities but
in the proposed text, the word is used twice to refer to the
concentration. Threet suggested that this could cause confusion and SDS
preparers may believe that when the concentration of chemical is
withheld, the chemical identity must be disclosed. Further, Threet
suggested that the proposed language implied that an SDS could merely
acknowledge that something was withheld as a trade secret but not
specify which category of information was withheld, and recommended
that OSHA add ``as appropriate'' to clarify (Document ID 0279, pp. 24-
25).
ICBA commented that the proposed language, which states the
chemical composition must be provided in accordance with the prescribed
concentration ranges, did not align with the language in paragraph
(i)(1)(iv), which requires that the concentration must be provided in
accordance with the prescribed ranges. ICBA expressed concern that
requiring the chemical composition as part of the concentration ranges
could reveal industry trade secrets, and requested that OSHA change the
language in Appendix D to reflect the same requirement as paragraph
(i)(1)(iv) (Document ID 0291, pp. 4-5). Michele Sullivan asked OSHA to
clarify that both the specific chemical identity and the percentage
concentration or concentration range can be claimed as trade secrets at
the same time (Document ID 0366, p. 9).
After reviewing comments from stakeholders, OSHA is modifying the
proposed text under For All Chemicals Where a Trade Secret is Claimed
in Section 3 of Table D.1. OSHA is adding ``and/or'' to the first
sentence and modifying the language about concentrations to read ``When
a trade secret is claimed in accordance with paragraph (i) of Sec.
1900.1200, a statement that the specific chemical identity, and/or
concentration (exact or range) of the composition has been withheld as
a trade secret is required.'' This should clarify that manufacturers
can claim the chemical identity and the concentration (exact or range)
as trade secrets at the same time or can claim any subset of these as a
trade secret. OSHA also agrees with the comments regarding the use of
the term ``composition'' in the second sentence and has accordingly
reworded to clarify that when the concentration or concentration range
is withheld as a trade secret, the HCS requires SDS preparers to use
the prescribed concentration ranges in Sec. 1910.1200(f)(1)(iv)-(vi)
in Section 3. OSHA is not, however, adding ``as appropriate'' to the
first sentence because the proposed language already makes clear that
the SDS must include a statement about which information is withheld as
a trade secret. OSHA is finalizing this version of the language
regarding trade secrets in Section 3.
In addition, as described in the NPRM, the HCS requires Section 3
of the SDS to include the chemical name and concentration (exact
percentage or ranges) of all ingredients which are classified as
``health hazards'' in accordance with paragraph (d). OSHA did not
propose changes to this requirement but requested comments on whether
the requirement should be expanded to also include chemicals classified
as physical hazards and HNOCs. In particular, OSHA asked whether
expanding the requirements for Section 3 in this way would ensure that
both users and manufacturers fully understand any potential hazard when
handling the chemical and whether such a change would result in the
provision of additional information that would allow downstream
manufacturers to more accurately classify their products where a
mixture with an ingredient that presents a physical hazard or HNOC is
one of their ingredients (86 FR 9689).
NIOSH supported expanding Section 3's requirements to all
classified chemicals for its potential to improve worker safety
(Document ID 0281, Att. 2, p. 6; 0423, Tr. 24). Similarly, John Baker
supported the change, noting it would be beneficial particularly
because of the potential for some nanoscale materials to form
combustible dusts (Document ID 0302). NABTU also stated that OSHA
should expand the requirements and that doing so would provide
construction workers and their employers with more complete information
on all exposure hazards. NABTU commented that ``specifying physical
hazards will also require more careful examination of potentially
deleterious effects to workers beyond health effects'' and noted that
construction workers would benefit from additional information about a
variety of hazards, such as aerosols, flammable gases and liquids, and
HNOCs. NABTU also expressed the belief that the HNOC classification
would be used infrequently (Document ID 0334, pp. 2-3; 0425, Tr. 23).
Several commenters opposed expanding the requirements of Section 3
to include ingredients classified as presenting physical hazards or
HNOCs (see, e.g., Document ID 0293; 0316, pp. 28-29; 0327, p. 7; 0345,
p. 6; 0346, pp. 2-3; 0347, pp. 22-23; 0359, p. 6; 0361, p. 3; 0366, p.
9). Several commenters stated that because the physical hazards of a
mixture as a whole cannot be determined based on the physical
properties of its ingredients, this requirement would only add
complexity to the SDS without increasing worker protection, and could
make it harder for workers to find relevant information (Document ID
0293; 0327, p. 7; 0329, p. 9; 0345, p. 6; 0346, pp. 2-3; 0347, pp. 22-
23; 0359, p. 6; 0366, p. 9).
Givaudan, Dow, ACC, and Michele Sullivan recommended against
expanding Section 3's requirements because it would be inconsistent
with the GHS and requirements of other U.S. trade partners (Document ID
0293; 0347, p. 22; 0359, p. 6; 0366, p. 9). Dow noted that doing so
could put the United States at a competitive disadvantage since some of
these components may be considered intellectual property (Document ID
0359, p. 6). The Flavor and Extract Manufacturers Association, HCPA,
NACD, and ADM also stated that expanding the Section 3 requirements
would not provide any additional helpful information regarding safe
handling of chemicals because other sections of the SDS provide that
information (Document ID 0327, p. 7; 0329, p. 9; 0346, pp. 2-3; 0347,
pp. 22-23; 0361, p. 3). NAIMA opposed expanding Section 3 requirements,
noting that doing so would impose
significant burdens (Document ID 0338, p. 10). OSHA appreciates
stakeholders' response to its request for comments. OSHA will consider
these comments in determining whether Section 3's requirements should
be expanded in a future update.
OSHA received one comment from an anonymous commenter about
inaccurate information presented in Section 3 of SDSs. The commenter
provided examples of inaccurate information such as SDSs listing
chemical composition as ``100% fertilizer'' or ``mixture,'' and not
providing accurate nutrient percentages (Document ID 0308). Although
this comment is beyond the scope of this rulemaking because it does not
relate to OSHA's proposed updates to the HCS, OSHA notes that many of
the changes in this final rule are intended to clarify the requirements
of the HCS for SDS preparers, in order to improve the accuracy of SDSs.
OSHA received a request from PRINTING regarding the existing
requirement to list impurities and stabilizing additives. PRINTING
requested guidance stating that downstream manufacturers may continue
to rely on information provided by their upstream suppliers. (Document
ID 0357, p. 3; 0423, Tr. 184-185). OSHA agrees that its modifications
to paragraph (d) and Appendix D, Table D.1 Section 3 have not altered
the ability of downstream manufacturers to rely on information from
upstream suppliers.
V. Section 8: Exposure Controls/Personal Protection
Section 8 of the SDS includes information on exposure controls and
personal protection. Section 8 (a) requires the SDS to include the OSHA
PEL, the ACGIH TLV, and any other exposure limit used or recommended by
the chemical manufacturer, importer, or employer preparing the SDS,
when available. OSHA proposed to revise Section 8 (a) to clarify that
this requirement applies to all ingredients or constituents listed in
Section 3 regardless of the concentration at which they are present in
a mixture. As OSHA noted in the NPRM, however, if the ingredient or
constituent does not have an OSHA PEL, ACGIH TLV, or any other exposure
limit or range used or recommended by the SDS preparer, then the
ingredient or constituent would not need to be listed in Section 8.
Several commenters supported this proposed revision to Section 8
(a) (Document ID 0313, p. 8; 0316, p. 29; 0338, pp. 8-9). Specifically,
NAIMA strongly supported the proposed revision and pointed out that
sharing information about PELs and TLVs with users communicates a clear
message about appropriate protections and supports intelligent and
informed choice on the use of respiratory protection (Document ID 0338,
pp. 8-9).
The American Pyrotechnics Association (APA) described the proposal
as ``adding known permissible exposure limits (PELs) and Threshold
Limit Values (TLVs) for every ingredient or constituent listed in
Section 3 of the SDS . . .'' and argued that PELs and TLVs are
irrelevant for finished pyrotechnic products because (1) these products
are designed to combust and are consumed by the reaction before any
personal exposure can occur and (2) if the products broke open in the
workplace workers would not be exposed to the chemicals themselves. APA
added that they ``believe this is also applicable to numerous mixtures
and compositions wherein the hazardous substances do not segregate nor
return to their separate ingredients after being bound together
chemically and/or physically'' and that including numerous PELs and
TLVs would lengthen the SDS. They requested that OSHA revisit this
proposal (Document ID 0337, p. 4).
APA's comment that OSHA has ``proposed adding'' known PELs and TLVs
for every ingredient or constituent misconstrues the nature of OSHA's
proposal. Following the publication of the 2012 HCS, the agency
received requests to clarify how an ingredient's concentration and role
in hazard classification relate to Section 8 requirements and
requirements to list the ingredients in Section 3 and, as discussed in
the NPRM (86 FR 9722), OSHA has issued LOIs clarifying that the
required exposure limits must be provided for any ingredient or
constituent identified in Section 3 of the SDS (see, e.g., Document ID
0088). OSHA's proposal in this rulemaking thus does not change any
existing requirements; it simply clarifies which ingredients Section 8
(a) applies to.
In addition, OSHA is not persuaded by APA's argument that the
consumption of chemicals contained in pyrotechnic products during their
use precludes occupational exposure to those chemicals. APA provided no
evidence demonstrating that the consumption of chemical components
during use of pyrotechnics results in no exposures to individuals in
the vicinity. Furthermore, APA's comment specifically references
circumstances where workers can experience exposure to hazardous
chemical components of pyrotechnic products: such products can rupture
in the workplace and workers must clean up the spilled materials
resulting from such accidents. For the reasons discussed above, OSHA
declines APA's request to reconsider the application of Section 8 (a)'s
requirements to individual ingredients of chemical mixtures.
Therefore, after reviewing the comments received on the inclusion
of the proposed language in Section 8 (a) to clarify that this
requirement applies to all ingredients or constituents listed in
Section 3 regardless of the concentration, OSHA is finalizing the
requirement as proposed.
OSHA also proposed to add a new requirement for SDS preparers to
include a range of exposure limits in Section 8 whenever a range is
used or recommended by the chemical manufacturer, importer, or employer
preparing the SDS. As explained in the NPRM, OSHA proposed this
requirement due to the availability of new tools, such as occupational
exposure banding or hazard banding methods, that provide a
concentration range (band) based on toxicity and hazard information
associated with a known chemical with similar properties. This range
can help inform appropriate risk management decisions where a specific
occupational exposure limit (OEL) or PEL is not available or is out of
date (86 FR 9722).
NIOSH, NABTU, and John Baker supported the proposed revision
(Document ID 0281, Att. 2, p. 6; 0302; 0334, p. 3; 0425, Tr. 23-24).
NABTU stated that, since quantitative and health-based occupational
exposure limits are only available for a small number of chemicals, the
inclusion of a range of exposure limits such as occupational exposure
banding improves hazard communication and safeguards workers. NABTU
added that exposure banding would move OSHA closer to the precautionary
principle embodied in the EU's REACH regulations that is intended to
protect workers when uncertainty exists about chemical hazards
(Document ID 0334, p. 3; 0425, Tr. 23-24).
John Baker recommended that the SDS should include a hyperlink or
other instructions on where the user can find supporting documentation
regarding how the range was established. Baker gave the example of
ranges established for nanomaterials, stating that these may be highly
dependent on parameters selected for the banding analysis (Document ID
0302). OSHA agrees that supporting documentation can provide valuable
information about exposure ranges. However, based on the format of and
preparation process for SDSs the
agency does not believe it is practical to require inclusion of this
information. Maintaining accurate and up-to-date hyperlinks and/or
instructions on where to locate appropriate contextual information can
be burdensome for SDS preparers, and employees who only have access to
paper copies of SDSs would not be able to use hyperlinks or similar
instructions to find supporting documentation. OSHA also notes that SDS
preparers may provide information on supporting documentation to users
in Section 16 of the SDS. OSHA is therefore not mandating inclusion of
a hyperlink or instructions for locating supporting information on how
the range was established.
OSHA received no comments objecting to the proposed requirement for
SDS preparers to include a range of exposure limits whenever a range is
used or recommended by the chemical manufacturer, importer, or employer
preparing the SDS, and is finalizing the requirement as proposed.
Several commenters did not oppose the proposed revisions but
suggested additional changes to the section. NIOSH recommended adding
the NIOSH Recommended Exposure Limit (REL) to the list of relevant
exposure limits, noting NIOSH is the only organization that offers OELs
in some cases, such as engineered nanomaterials (Document ID 0281, Att.
2, p. 6; 0423, Tr. 24). NABTU similarly stated that, because few
occupational exposure limits for engineered nanomaterials have been
established, NIOSH RELs should be required on SDSs to convey the most
accurate and appropriate hazard information for engineered
nanomaterials (Document ID 0464, p. 7). Cal/HESIS also recommended
adding the NIOSH REL to the list of occupational exposure limits, as
well as California's Risk Management Limit for Carcinogens (RML-CA).
Cal/HESIS further recommended requiring state- or territory-specific
PELs (such as Cal/OSHA PELs) to be listed for substances that lack
federal occupational exposure limits and are sold in a particular state
with an OSHA-approved State Plan. Cal/HESIS reasoned that SDSs should
advise employers and workers that an exposure limit has been
established by a specific state or other non-regulatory organization
for a substance, even if a PEL is not established by federal OSHA. Cal/
HESIS provided supporting information from its review of SDSs for
products sold in California that contained 1-bromopropane, a carcinogen
that lacks a federal OSHA PEL, and the agency found that 80 percent of
SDSs did not include the Cal/OSHA PEL for 1-bromopropane. Therefore,
Cal/HESIS concluded, California users of these SDSs could erroneously
conclude California does not regulate 1-bromopropane (Document ID 0313,
p. 8).
ICT suggested that OSHA should add a provision from Section G.5.d
of OSHA's compliance directive (Document ID 0007), which allows
chemical manufacturers and importers to state ``The following
constituents are the only constituents of the product which have a PEL,
TLV or other recommended exposure limit. At this time, the other
constituents have no known exposure limits'' in Section 8 of the SDS
(Document ID 0066, p. 66). ICT requested that OSHA modify Section 8 to
codify this language, noting that Section 3 of the SDS often contains
substances that do not have established OELs (Document ID 0324, pp. 6-
7).
OSHA agrees with those commenters who stated that the NIOSH REL and
state-specific limits can provide important information to chemical
users; however, the suggested changes are out of scope for this
rulemaking. While OSHA did propose to add ``or range'' to Section 8,
indicating a broader scope of what needs to be listed, it did not
propose to add RELs or otherwise modify the information required
regarding OELs. Adding these limits as requirements would be a
substantive change to the content of an SDS. Because OSHA did not
indicate in the proposal that it was considering such a change, the
agency believes stakeholders lacked sufficient notice for OSHA to adopt
the commenters' suggestions in this final rule. The agency notes,
however, that Section 8 (a) may include any exposure limit or range
used or recommended by the chemical manufacturer, importer, or employer
preparing the safety data sheet, where available.
With regard to ICT's request to add language from OSHA's directive,
OSHA notes that ICT did not provide any justification for why adding
this language to the HCS text of Appendix D would be useful and OSHA
has not received any other comments suggesting that there is ambiguity
about the fact that employers are allowed to add that statement. To the
extent that ICT is requesting that OSHA mandate the inclusion of that
statement about no other known exposure limits on SDSs, OSHA did not
propose such a change and the agency considers such a suggestion
outside the scope of this rulemaking.
ACC submitted a comment requesting that OSHA remove the requirement
to list OELs developed by voluntary standards organizations such as
ACGIH TLVs. ACC suggested that OSHA should only require the listing of
OELs that have been developed through a federal rulemaking process
because those limits have been determined to be feasible. ACC argued
that the requirement to include OELs developed by voluntary standards
organizations creates the erroneous impression that they carry the same
regulatory weight as OSHA PELs (Document ID 0347, p. 24).
Inclusion of the TLVs and other OELs on the SDS has been a
requirement since 1983 (48 FR 53280, 53343). During the rulemaking
process for the 2012 HCS, OSHA received comments similar to ACC's; the
agency explained and reaffirmed its longstanding position that TLVs and
other OELs provide useful information and should continue to be
included (77 FR 17573, 17731-34). OSHA continues to affirm this
position. Regardless, this comment is out of scope because the agency
did not propose a change to this requirement.
OSHA also received one comment regarding Section 8 (c), which the
agency did not propose to change in the NPRM. Monica Hale commented
that OSHA should add a requirement for manufacturers to list the
specific types of required PPE in Section 8 based on the ``actual
hazard'' and should not be permitted to include generic statements such
as ``use appropriate glove'' or ``use appropriate NIOSH Approved
Respirator'' (Document ID 0286). Because OSHA did not propose to change
Section 8(c), this comment is out of scope for this rulemaking and the
agency has not added the suggested language. Several other commenters
raised similar concerns with regard to the language about PPE required
on labels in Appendix C, and this issue is discussed in more depth in
the Summary and Explanation of Appendix C.
In conclusion, for the reasons discussed above, OSHA is finalizing
all changes as proposed in Section 8 of the SDS.
VI. Section 9: Physical and Chemical Properties
OSHA proposed several updates to Section 9, Physical and chemical
properties. OSHA proposed to revise the text of Section 9 to align with
Rev. 7 by listing the required physical and chemical properties of the
chemical in the same order that appears in Annex 4 of the GHS (Document
ID 0060, p. 38). OSHA reasoned that this change would simplify the
preparation of SDSs for chemical manufacturers who prepare them for
global distribution. Similarly, OSHA also proposed aligning Section 9
with Rev. 7 by replacing ``appearance''
with ``physical state'' and ``color''; eliminating ``odor threshold''
and ``evaporation rate'' as separate required properties; adding the
term ``kinematic'' to the property ``viscosity'' to better define the
appropriate parameter to be characterized (i.e., kinematic as opposed
to dynamic viscosity); and adding ``particle characteristics'' as a new
physical property for solids. OSHA stated in the NPRM that particle
characteristics only apply to solids and should include the particle
size (median and range) and, if available and appropriate, further
properties such as size distribution (range), shape, aspect ratio, and
specific surface area (86 FR 9723).
OSHA received several comments on these proposed changes. API
requested clarification on whether the physical and chemical properties
must be ordered on the SDS in the same sequence that OSHA proposed to
list them in the text of Appendix D (Document ID 0316, pp. 29-30). NACD
expressed concern that individuals who read SDSs and labels would need
to adjust to a re-ordered list of physical and chemical properties and
that making this change would not enhance safety (Document ID 0329, p.
9).
As OSHA explained in the NPRM, the proposal to list the required
physical and chemical properties of the chemical in the same order that
appears in the GHS applies to the order in which they appear in the
text of the HCS, not to the order in which they appear on the SDS. SDS
preparers are not required to list the physical and chemical properties
in any particular order (86 FR 9722-9723). This also means that the
order of the physical and chemical properties on the SDSs would not
need to change and therefore individuals who use SDSs would not need to
adjust or relearn anything about where the information is located.
NIOSH recommended that information on odor threshold be retained on
the SDS because detection of odor can be usefully combined with other
information on toxic potency, for example, in cases where an odor
threshold concentration can be compared to health-based ambient
criteria (Document ID 0281, Att. 2, p. 7). Cal/OSHA commented that
since odor threshold can be an important way to ``roughly'' assess the
risk level, it should be provided for all chemicals. Cal/OSHA
recommended retaining the odor threshold along with a statement
regarding olfactory fatigue (Document ID 0322, Att. 2, p. 13). NIOSH
and Cal/HESIS commented that, since the evaporation rate can be
important for assessing the risk from material spills, it should be
retained on the SDS (Document ID 0281, Att. 2, p. 7; 0423, Tr. 24-25;
0313, p. 9).
OSHA did not intend to eliminate the requirement to state the odor
threshold on the SDS. The agency proposed to remove ``Odor threshold''
as a separate property from Section 9 in order to align with Rev. 7,
which does not require an ``Odor threshold'' property in Section 9.
However, Annex 4 of Rev. 7 states that a substance's odor property
should indicate the odor threshold, if available (Document ID 0060, p.
387). OSHA's intent was to align with Rev. 7 by eliminating ``odor
threshold'' from the list of properties but maintaining the requirement
to report it by requiring it under the existing odor property already
in Section 9. To prevent any future confusion, OSHA is adding a
parenthetical stating ``includes odor threshold'' in Section 9 (c)
Odor, thus indicating that SDSs preparers need to specify odor
threshold for the substance, if available. OSHA is declining the
recommendation to require a statement regarding olfactory fatigue since
this recommendation does not align with Rev. 7 and Section 9
information requirements are limited to physical and chemical
properties. However, OSHA notes that manufacturers may elect to include
a statement regarding olfactory fatigue.
With regard to evaporation rate, OSHA did propose to remove it from
the list of properties in Section 9 to align with Rev. 7. The UNSCEGHS
agreed to remove ``evaporation rate'' during revision of the GHS Annex
4 on the basis that it ``is effectively covered by the vapour pressure,
and all aspects that are important with regard to occupational safety
and the risk of exposure can be dealt with based on the vapour pressure
and the saturated vapour concentration'' (Document ID 0129, p. 3).
However, OSHA agrees with the point made by NIOSH and Cal/HESIS that
``Evaporation rate'' is important to include in Section 9, as ready
access to this information may be needed to evaluate the health and
fire hazard qualities of chemicals and other substances in emergency
situations. OSHA is therefore adding a parenthesis stating ``includes
evaporation rate'' in Section 9 (o), Vapor pressure.
NIOSH, Cal/HESIS, NABTU and John Baker supported the addition of
``particle characteristics'' as a new physical property in Section 9
(Document ID 0281, p. 7; 0313, pp. 8-9; 0302; 0423, Tr. 24; 0425, Tr.
24; 0464, p. 7). Cal/HESIS recommended that the proposed text should be
revised to specifically include particle size distribution as a
required type of particle characteristic, noting that particle size is
an important determinant of particle behavior in air and how the
inhaled particles are deposited in the respiratory system (Document ID
0313, pp. 8-9). NIOSH stated that ``particle characteristics are
critical determinants of the toxicity of inhaled particles'' and
provided suggested particle characteristics with standardized methods
(Document ID 0456, Att. 2, p. 3). NIOSH suggested that surface
reactivity and density are also important determinants of the toxicity
of particles, and suggested standardized test methods for those
measurements (Document ID 0456, Att. 2, p. 3). In addition, NIOSH
stated that over the last 20 years particle characteristics have become
critical in terms of their hazard potential and the kinds of control
approaches that are needed, particularly with the advancement of
commercial nanotechnology (Document ID 0423, Tr. 40-41). NABTU
concurred with NIOSH's assertion and pointed out that manufacturers are
utilizing nanoparticles (or engineered nanomaterials) increasingly in
numerous industry sectors, but not necessarily including information
about nanoparticles in SDSs, and there is a clear need to improve
hazard communication concerning particle size and other particle
characteristics in order to understand the associated hazards to
construction workers (Document ID 0425, Tr. 24; 0464, p. 7).
OSHA agrees that particle size distribution can be an important
indicator of the potential for a solid particle to pose a hazard; as
discussed in the NPRM, particles that are less than 100 microns
increase the likelihood of exposure, especially through the route of
inhalation (86 FR 9723; Document ID 0060, p. 117; 0129). OSHA also
agrees with NIOSH regarding surface reactivity and density; if
information on these characteristics is available, it should be
included in the SDS. OSHA is not, however, including a list of particle
characteristics that must be included because not all of this
information is available for all chemicals covered by this provision.
Additionally, because the HCS does not require testing, OSHA is not
requiring testing for particle characteristics as NIOSH suggested, but
notes that manufacturers must include these measurements, if available.
John Baker argued that the proposed requirement to provide particle
characteristics to Section 9 of the SDS should not be restricted to
solids because liquids containing nanoparticles could pose a hazard
particularly if there is a change in physical form (Document ID 0302).
OSHA recognizes that solid nanoparticles in liquid can pose a
hazard, especially when the liquid is aerosolized and the nanoparticles
become airborne. In the NPRM, when OSHA stated that ``particle
characteristics apply to solids only . . .,'' it intended to include
nanoparticles in its meaning of solid (86 FR 9723). Nanoparticles in a
liquid are themselves in a solid form, and therefore SDS preparers are
required to list characteristics of those nanoparticles in Section 9.
Some commenters expressed confusion over the addition of ``particle
characteristics.'' ICBA and PLASTICS asked for clarification about what
data OSHA is seeking to capture by adding this term to Section 9
(Document ID 0291, p. 5; 0314, p. 21). As noted above, OSHA included in
the NPRM a list of particle characteristics it intended for SDS
preparers to provide, when available, and agrees with NIOSH that
surface reactivity and density are also relevant particle
characteristics that should be included.
NAIMA opposed the addition of ``particle characteristics'' as a new
physical property in Section 9, including the proposed requirements to
include median and range of particle size, size distribution, aspect
ratio, and specific surface area. According to NAIMA, these particle
characteristics are highly sensitive to certain production
characteristics, and it would be hard to address attrition that might
occur during application (Document ID 0338, p. 8).
In response to NAIMA's comment, OSHA notes that the requirement
pertaining to particle characteristics is limited to cases where a
substance's particle characteristics are available and appropriate. If
particle characteristics are not known, OSHA does not expect importers
or manufacturers to perform testing to determine particle
characteristics, consistent with the fact that the HCS does not require
testing. However, the agency notes that many manufacturers already have
this information available since this is an important commercial
attribute provided to customers. Additionally, OSHA would not expect
the SDS preparer to include the particle characteristics following
attrition that could occur during downstream processing since, as NAIMA
pointed out, this would be difficult to predict for all situations.
For the reasons discussed above, OSHA is finalizing the proposed
revisions with clarifying additions in Section 9 (c) and (o).
VII. Footnote in Sections 7 and 9
OSHA requested comments on whether it should add a footnote to
Section 9 that is similar to the footnote the agency proposed to add to
Appendix B.6.3. This footnote would explain that to determine the
appropriate storage container size and type, the boiling point for a
flammable liquid must be determined by paragraph (a)(5) of OSHA's
Flammable Liquids standard (29 CFR 1910.106(a)(5)), which allows for an
alternate method to determine the boiling point under certain
circumstances. If a manufacturer uses the alternative method to
determine the boiling point for storage purposes, they must note that
on the SDS in Sections 7 and 9 if the classification for storage
differs from the classification listed in Section 2 of the SDS.
ACC objected to the proposed note, including the requirements
pertaining to Sections 7 and 9 of the SDS, because they believe that it
would not provide any additional worker protection. ACC further asked
OSHA to clarify why this provision was proposed, noting that it is not
in the GHS Rev. 7 or 8 (Document ID 0347, p. 23). OSHA addressed ACC's
comments, along with other comments specifically on the footnote in
B.6.3, in the Summary and Explanation for Appendix B and finalized the
footnote, with modifications for clarity.
OSHA received one comment specifically on the addition of the
footnote to Appendix D, from Ameren, which agreed that it would be
appropriate to add a footnote like the one proposed for B.6.3 to
Appendix D for Section 9 (Document ID 0309, p. 17). OSHA agrees that a
similar footnote should be included in Appendix D since Appendix D,
Table D.1 lists what must be included in the SDS, and the footnote
requires that in some cases this additional information is added to the
SDS. However, OSHA has concluded that the footnote should be referenced
in both Section 7 and Section 9, since it refers to information in both
SDS sections. Adding the footnote, as modified, will ensure that if the
storage recommendations appear to be in conflict with classification
for flammable liquids in section 2 of the SDS, the preparer will
appropriately mark the SDS in both Section 7 and Section 9 so the
downstream user knows that the recommendations for storage of flammable
liquids are correct. While OSHA believes this will be a rare
occurrence, the addition of the use of the alternative method for
boiling point ensures that the accuracy of the SDS is not in doubt.
Therefore, OSHA is adding the footnote, as modified for B.6.3, in
Appendix D.
VIII. Section 10: Stability and Reactivity
Section 10 of the SDS, Stability and reactivity, includes the
requirement in Section 10 (c) that preparers include information about
the possibility of hazardous reactions. In the NPRM, OSHA proposed to
clarify that this includes hazardous reactions associated with
foreseeable emergencies.
OSHA received several comments expressing concerns about the
proposed requirement. These arguments largely mirror the arguments
raised regarding paragraph (d). For instance, commenters raised
concerns about the feasibility of preparing comprehensive hazard
classifications for every possible use of a product (Document ID 0277,
p. 3); the vagueness and breadth of the language proposed (Document ID
0347, pp. 25-26); the difficulty of obtaining continuous information
from downstream users (Document ID 0348, p. 2); and the likelihood of
over-warnings to avoid risk of regulatory citations and confusion about
what hazards are associated with a chemical substance (Document ID
0356, pp. 9-10). These arguments and others are discussed further in
the Summary and Explanation for paragraph (d).
Several commenters also suggested changes to the proposed text. Tom
Murphy suggested that Section 10 (c) should be limited to universal
conditions applicable to anyone in possession of the chemical product
(Document ID 0277, p. 3). ACC suggested adding the phrase ``for
directed uses'' (Document ID 0347, pp. 25-26). The Vinyl Institute
suggested removing the proposed text from Section 10 of Table D.1 for
the same reason they opposed the proposed revisions to paragraph (d)
(Document ID 0369, Att. 2, p. 8) (see the Summary and Explanation of
paragraph (d)).
The proposed change in Section 10 (c) was consistent with the
language OSHA proposed for paragraph (d)(1). OSHA proposed to add
``including those associated with foreseeable emergencies'' in Section
10 (c) to clarify that possible hazardous reactions also include
hazardous reactions which may occur during foreseeable emergencies and
to be consistent with the proposed revision to paragraph (d)(1). While
the version of paragraph (d)(1) that OSHA is finalizing no longer
aligns with the proposed change in 10 (c), OSHA still believes this
clarification is warranted to ensure that downstream users are aware of
potential hazardous reactions associated with foreseeable emergencies.
OSHA is not convinced
that this would be a heavy burden since it is not tied to the
classification process but a general warning of when a hazardous
situation can occur. Therefore, adding the phrase ``for directed use''
as ACC suggests would not capture the intent of this requirement. This
revision is also consistent with the GHS which indicates that the SDS
preparer should describe the conditions in which the hazardous reaction
could occur (Document ID 0060, p. 400).
IX. Section 11: Toxicological Information
OSHA proposed to revise Section 11, Toxicological information, to
align with Rev. 7 (Document ID 0060, p. 395) by adding a new Section 11
(e), Interactive Effects. Because of that proposed change, OSHA also
proposed moving the former Section 11 (e) to Section 11 (f).
Additionally, OSHA proposed to add a new Section 11 (g) providing that
when specific chemical data or information is not available, SDS
preparers must indicate if alternative information was used and what
method was used to derive the information (e.g., where the preparer is
using information from a class of chemicals rather than the exact
chemical in question and using structure-activity relationships (SAR)
to derive the toxicological information).
With regard to proposed Section 11 (e), several commenters
requested a definition of ``interactive effects'' and sought
clarification of specific requirements of the proposal. Tom Murphy
commented that the proposal did not contain a definition of interactive
effects and that a lack of clarity creates a ``potential for systemic
failure.'' Murphy suggested that this issue could be resolved by
defining the term interactive effects or striking the requirement
(Document ID 0277, p. 2). Similarly, ACC requested clarification of
``interactive effects'' as they felt it was not clear from the NPRM or
GHS what this proposed provision entails (Document ID 0347, p. 26).
Michele Sullivan asked why OSHA proposed to add interactive effects
to the SDS, suggesting that the requirement was inadequately explained
in both the GHS and NPRM and noting it is not included in UN GHS Table
1.5.2 Minimum information for an SDS. Sullivan suggested that including
this information was not ``necessary or related to worker safety'' and
that OSHA should align as closely as possible with the GHS Table 1.5.2
from the UN GHS Purple Book to promote global harmonization (Document
ID 0366, p. 9).
While ``interactive effects'' are not listed in Table 1.5.2, the
term is mentioned in Appendix 4 Guidance on the preparation of the
safety data sheet (SDS) paragraph 4.3.11.11 (Document ID 0060, p. 401).
``Interactive effects'' such as synergistic or antagonistic effects
occur when some or all individual components (ingredients) of a mixture
influence the toxicity of individual ingredients and the combined
effects deviate from additive predictions (see related considerations
in Appendix A.0.4--Considerations for the classification of mixtures).
When an SDS preparer has information that the combination of chemicals
in a mixture have a different level and/or type of toxicity than would
be predicted by adding the toxicity of its components, the preparer
should state that on the SDS and describe the nature of the interactive
effects. OSHA recognizes that testing and studies are often required to
produce information on interactive effects. Since neither the GHS nor
OSHA require testing, this information need only be disclosed if the
toxicological data is available without testing. OSHA disagrees with
Michele Sullivan's comment that this requirement would not benefit
worker safety; OSHA proposed adding this provision because it
understood this to be a gap in the information provided in the SDS that
could be important for understanding the hazards present in a
workplace.
With regard to proposed Section 11 (g), ACC supported the inclusion
of QSAR (quantitative SAR) and read across, which it characterized as
``powerful and valuable tools for evaluating toxicological
information.'' However, ACC requested clarity regarding what OSHA
intended with the phrase ``if alternative information is used'' in
proposed Section 11(g). (Document ID 0347, p. 26).
In the NPRM, OSHA noted several tools that would qualify as ``using
alternative information'' under proposed Section 11 (g), including SAR,
QSAR, and read across, which are used in the absence of specific data
on a particular chemical to predict activities, properties, and
endpoint information of untested chemicals based on their structural
similarity to tested chemicals (86 FR 9723). When SDS preparers lack
known chemical specific data, OSHA intends for this provision to
require preparers to note that they have used other methods such as
SAR, QSAR, and read across to provide toxicological information in
Section 11, and then to describe the method they used for translating
the non-specific data into toxicological information relevant to the
untested chemical in question. Making such information accessible in
the SDS to health and safety professionals could be useful to determine
what kind of controls and PPE may be needed to protect workers who
handle these chemicals.
NACD commented that the proposed Section 11 (g) ``essentially asks
[SDS] preparers to provide information about their data sources.'' NACD
recommended that OSHA clarify when this is required and what specific
information the agency is seeking. They also suggested that OSHA should
update its chemical registries and chemical substance guidebook online
(Document ID 0329, p. 9). OSHA notes that, while it is not clear which
specific materials NACD is asking OSHA to update, the agency will be
updating its HCS guidance to provide additional information and support
for compliance with the final rule and anticipates including these
topics.
Proposed Section 11 (g) requires that SDS preparers note if the
toxicity information for a chemical on the SDS is derived from studies
which used data that is not specific to the chemical in question and
which method was used to make that determination (for instance, QSAR or
read-across methods). As NIOSH stated at the hearing, ``structure-
activity relationships, analogs of chemicals, and chemical families are
all useful characteristics for understanding the toxicity of a
chemical, particularly when there is little toxicity information about
the particular chemical of interest'' (Document ID 0423, Tr. 42-43).
NIOSH noted that it would be particularly useful to include such
information on the SDS ``for those chemicals for which the chemical
families or the SAR have been well studied and well supported in the
scientific literature'' (Document ID 0423, Tr. 42-43). NIOSH also
cautioned that ``when the analogs, the SAR, and the chemical families
are not well-defined or there is conflicting information about the
critical characteristics of the analog chemicals for comparison'' it
can be difficult to interpret that information. Further, because no
standard set of information on which to characterize SAR, analog, or
chemical families currently exists, it may be difficult to provide
guidelines to employers on what information to include (Document ID
0423, Tr. 42-43). OSHA agrees with this analysis of the state of the
science regarding these methodologies. Ultimately, the SDS preparer
must include the information in the toxicological information section
unless they determine that it is of such
a quality as would not materially aid hazard communication.
Michele Sullivan also noted that Section 11 (g) does not appear in
GHS Table 1.5.2 and therefore is not harmonized with the GHS, so SDS
preparers should be allowed to use alternative methods (i.e., SAR,
QSAR, read-across) to derive toxicity information but they should not
be required to specify that alternative methods were used on the SDS
because it would not be helpful or necessary for workers' safety
(Document ID 0366, p. 9).
While OSHA supports the use of alternative methods to derive
toxicity information, the agency notes that most of these methods would
not be used as stand-alone (without the addition of in vivo or in vitro
data) to classify hazardous substances. The requirement to provide
information on the use of alternative methods in the classification
allows the reader to evaluate the basis for the classification.
Further, OSHA disagrees with the assertation that the proposed
requirement does not align with GHS simply because the requirement is
not listed on Table 1.5.2. Table 1.5.2 in the GHS is meant to list
minimum information for an SDS (Document ID 0060, pp. 38-39). The GHS
provides more detail about SDS requirements in the paragraph A4.3.11.12
of Annex 4 which specifies that when genetic data are used, or where
data are not available, that information should be noted in the SDS
(Document ID 0060, p. 396).
For the reasons discussed above, OSHA is finalizing all of the
changes to Section 11 of the SDS as proposed, including new Section 11
(e), the shifting of the prior Section 11 (e) to Section 11 (f), and
the new Section 11 (g).
X. Section 14: Transport Information (Nonmandatory)
OSHA proposed to change non-mandatory Section 14 (f), Transport
information, to read ``Transport in bulk according to IMO instruments''
instead of ``Transport in bulk (according to Annex II of MARPOL 73/78
and the IBC Code)'' to be consistent with the text in Rev. 7, which
better aligns with the IMO (Document ID 0060, p. 39; 0141). OSHA
received no comments objecting to the revision in Section 14.
Therefore, OSHA is finalizing Section 14 as proposed.
G. Out of Scope Comments
As explained in the introduction to the Summary and Explanation,
OSHA addresses all relevant comments submitted as part of a rulemaking.
The agency received some comments that were submitted as part of the
rulemaking process but are outside the scope of the rulemaking. This
section addresses any such comments that are not addressed in other
sections of the Summary and Explanation.
DOD commented that OSHA should expand the types of hazards reported
on SDSs and labels by aligning with the EU REACH regulation (Document
ID 0299, p. 5). OSHA did not propose the adoption of any provision
within REACH and cannot expand the types of hazards covered by the HCS
without notice and comment on the issue, so the agency declines to
adopt DOD's proposed changes.
OSHA received an anonymous comment regarding the classification of
plastic articles which requested that ``the correct approach for the
classification of polymer compounds and concentrates . . . be specified
in the proposed rule'' (Document ID 0269). Since articles are exempt
from the HCS and OSHA did not propose any changes to the standard that
are relevant to the commenter's concerns, this comment is out of scope
for this rulemaking and the agency declines to take the action
requested in this comment.
An anonymous commenter suggested that OSHA should revise the
training requirements for SDSs to reduce the amount of training but
make it more useful for workers (Document ID 0300). OSHA did not
propose any changes to the training provisions of the HCS, therefore
the suggestion is out of scope for this rulemaking and the agency
declines to adopt the commenter's proposed changes.
OSHA received another anonymous comment asking OSHA to extend the
HCS to workers who are not currently covered by the standard, including
State employees not covered by OSHA's regulations (Document ID 0306).
The comment suggested a number of options for extending the population
of workers covered by the HCS that are not within OSHA's power to
implement. The agency appreciates the dilemma faced by the commenter
and those not protected by the HCS, but States are specifically
exempted from being an employer under the OSH Act (29 U.S.C. 652(5)).
OSHA therefore cannot take any action in response to this comment.
Loren Lowry, a private citizen, commented that SDS preparers and
hazard classifiers do not apply the HCS or GHS the same way when
developing hazard classifications for the same chemicals (Document ID
0333). OSHA recognizes this issue and has developed guidance to help
stakeholders correctly apply the HCS hazard classification criteria to
their chemical or substance. In addition, Lowry noted that countries
are able to adopt parts or all of the GHS which leads to
disharmonization (Document ID 0333, p. 1). While OSHA recognizes the
issue as well, it is not within the agency's power to address uneven or
incomplete adoption of the GHS amongst foreign nations.
WHSP submitted comments related to nanotechnology and international
developments (Document ID 0341). While the agency appreciates the
submission, these comments are outside the scope of this rulemaking.
Cal/OSHA commented that the decision-making procedures for
classifying and labelling chemicals are absent from this proposal
(Document ID 0322, Att. 1, p. 2). OSHA notes that this issue was
discussed during the 2012 HCS update (77 FR 17719, 17795, 17799) and
OSHA did not propose any changes related to this issue in this
rulemaking. Therefore, Cal/OSHA's comments on this matter are outside
the scope of this rulemaking and OSHA declines to make any changes to
the rule in response.
XV. Issues and Options Considered
In the NPRM, OSHA solicited public feedback on specific issues
associated with the proposed revisions to the HCS in the Issues and
Options section, including timeframes for updates, issues related to
proposed regulatory text and appendices (e.g., questions on (f)(12)
small container labeling requirements), economic analyses, and
potential guidance documents. The Issues and Options section also
presented optional potential changes to the regulatory text and
appendices associated with Rev. 8 of the GHS (e.g., inclusion of non-
animal test methods in Appendix A.3.1--skin irritation and corrosion).
For discussion of issues and options related to economic analyses,
regulatory text, and appendices, please refer to those specific
discussions in Section VI, Final Economic Analysis and Regulatory
Flexibility Analysis, or Section XIV, Summary and Explanation of the
Final Rule, for that specific provision. The remainder of this
discussion addresses comments submitted on the timeframe for updates to
the HCS and on electronic labeling.
A. Timeframe for Updates to the HCS
Since aligning the HCS with Rev. 3 in 2012, OSHA has intended for
the HCS to stay current with more recent revisions of the GHS. The GHS
is updated biennially through published revisions; most recently, Rev.
9 was published in July 2021 (available at https://unece.org/transport/
standards/transport/dangerous-goods/ghs-rev9-
2021). Regulatory authorities around the world have implemented the GHS
at stages ranging from Rev. 1 through Rev. 7. Few regulatory
authorities have put programs in place to update their regulations on a
routine schedule. The EU has made the most regular updates, and in
March 2019, the European Commission (EC) published the adaptation of
technical progress (ATP) to EC regulation 1272/2008 (the CLP
regulation) to align with both the sixth and seventh revised editions
of the GHS (Document ID 0176). These changes to the CLP regulation
became effective October 2020. Other regulatory authorities, such as
those in Canada, Australia, and New Zealand, have updated their
regulations to align with the GHS and have either finalized or are in
the process of aligning with Rev. 7; however, none of these countries
have a mandate on how often they should do so (Document ID 0172; 0168;
0187). Similarly, to date, OSHA has not adopted a specific timeframe
for regularly updating the HCS to implement GHS updates.
OSHA requested public comment on whether the agency should adopt a
schedule for updates to the HCS standard (e.g., every four years or
every two revisions of the GHS) or wait until there are significant
changes to the GHS before initiating rulemaking. The agency received
several comments on the question but received no consensus on a
specific timeframe for updating the HCS.
Hugo Hidalgo commented that ``the revision and updates to the HCS
must be close together with the GHS latest versions to ensure alignment
with the rest of the world, requiring a strong relationship with US
major trading partners'' (Document ID 0297, p. 4).
CGA and GAWDA commented that OSHA should review the HCS every two
revisions of the GHS to determine if the changes are substantive enough
to reach ``a threshold that would necessitate'' implementing a change,
which they noted ``would help to ensure that the time, cost, and effort
required to meet new requirements would result in enhanced employee
safety'' (Document ID 0310, p. 3). Similarly, SAAMI suggested that OSHA
realign with the GHS every four years or two revisions (Document ID
0370, pp. 2-3). Hach recommended updates to the HCS every 8 years, or
every fourth revision, while Michele Sullivan indicated that every 5 or
6 years may be more appropriate (Document ID 0323, p. 11; 0366, p. 10).
Others indicated it would be more appropriate to coordinate updates
either with trading partners or the DOT (Document ID 0279, p. 3; 0347,
p. 27; 0364, pp. 2-3).
The Flavor Extract Manufacturers Association, Hawkins, and FCA
suggested that OSHA should maintain a regular schedule for updates to
provide more regulatory certainty to companies, but did not provide a
suggested schedule (Document ID 0346, p. 3; 0423, Tr. 193; 0349, p. 6).
IHSC noted ``it is important to periodically revise the standard to
stay aligned with the international standards to take advantage of the
hard work done by our representatives to the UN subcommittee and the
various working agencies'' (Document ID 0349, p. 1).
Cal/HESIS recommended that OSHA update the HCS ``only when there
are significant changes to the GHS that would justify opening
rulemaking'' and that OSHA should have flexibility in determining the
need as a fixed schedule ``may not be in the interest of all involved
given the resources and effort required'' (Document ID 0313, p. 3).
Some other stakeholders' comments similarly suggested that OSHA should
update the HCS when significant or substantial changes to the GHS have
occurred, or when these changes will lead to improved worker
protections (Document ID 0309, p. 11; 0327, p. 3; 0329, p. 2; 0344, p.
3; 0368, p. 11).
NIOSH also recommended that OSHA update the HCS only when
significant changes to the GHS warrant rulemaking, noting that
``[a]dhering to a regular schedule to update the OSHA HCS might not be
prudent given the resources and effort required--especially if there
were minor adjustments to the GHS that would not require major
revisions to the HCS'' (Document ID 0456, Att. 2, p. 2). Dow also
supported updating the HCS when there are substantial updates in order
to maintain harmonization with trading partners, but noted that ``an
update should be justified by advancement in science or technology
resulting in clear benefits to worker safety'' (Document ID 0359, p.
1). NAIMA supported less frequent HCS updates to incorporate
significant changes to the GHS because there are significant compliance
costs associated with HCS updates (Document ID 0461, pp. 8-9).
After careful consideration, the agency agrees with commenters who
argued it is more prudent to only update the HCS when significant
changes have occurred to the GHS that require realignment to improve
worker safety.
B. Electronic Labeling
In the NPRM, OSHA requested comments on using electronic
technology, such as quick response (QR) codes and radio-frequency
identification (RFID) for labeling chemical packaging. OSHA was
interested in gathering information from stakeholders on what
technological, economic, and security challenges employers would face
if electronic labeling was permitted in a future HCS revision. The
agency also requested comments on the types of electronic chemical
labeling already in existence or under development, information on the
types of electronic coding systems utilized and the costs incurred, and
benefits achieved from the programs if implemented. In addition, OSHA
asked what backup measures are in place to ensure immediate access to
the hazard information. OSHA was interested in gathering information
about workers' experiences with electronic labels, and foreseeable
challenges that OSHA should consider (e.g., worker accessibility to
electronic label information) (86 FR 9690).
Many commenters supported exploring the use of electronic labels in
the future (Document ID 0309, p. 13; 0327, p. 6; 0347, pp. 20-21; 0297,
p. 3). Commenters stated that using technology (e.g., QR codes and
RFID) for labels and SDSs will provide a quick (Document ID 0261), easy
(Document ID 0368, p. 8), universal (Document ID 0271), and efficient
(Document ID 0281, Att. 2, p. 7) way to access hazard information about
the chemicals at workplaces. Givaudan indicated strong support and
urged OSHA to implement the use of electronic labels (Document ID 0293,
p. 1). Hugo Hidalgo indicated that given the worldwide use of this
technology, hard copies should not be the only way to comply with the
HCS (Document ID 0297, p. 4).
Some commenters suggested that OSHA should make electronic labeling
optional, but raised concerns about the possibility of broad
implementation (Document ID 0316, p. 7; 0329, p. 9). Specifically, API
indicated that this provision should be optional and further
stakeholder engagement would be beneficial as there may be concerns
related to wide use of electronic labels, including limited use of
mobile phones in many workplaces, additional costs for implementation,
and no demonstrated need for (and perhaps limited benefit of)
electronic labels (Document ID 0316, pp. 7-8). They indicated that
using digital hazard information during the transport phase could be
useful, but implementing such provisions could require extensive
revisions to the GHS (Document ID 0316, p. 8). Relatedly, IMA-NA
commented that this would be costly and not work as a blanket approach
across industries (Document ID 0363, pp. 8-9).
Additionally, NIOSH supported OSHA's consideration of utilizing
newer technology options, such as QR codes, RFID, or website addresses,
to link to pertinent labeling information and SDSs. However, they also
commented that electronic labeling should not be a substitute for
maintaining label information and SDSs in the workplace in a physical
form because in emergencies there must be a backup means of accessing
the label and SDS in case the container becomes compromised or
inaccessible (Document ID 0281, Att. 2, p. 7).
Similarly, NABTU commented that electronic technology for labeling
could improve the ability of manufacturers and importers to provide
chemical hazard information, including access to emergency medical and
first aid information, which they noted remains a challenge on
construction sites. However, they stated that it should not be
substituted for the hazard information and pictograms already required
on labels. They provided examples of QR codes that are already being
used in the construction industry to train workers on using hazardous
equipment, working at heights, and accessing SDSs for masonry and
concrete products. NABTU pointed out that the HCS already permits
employers to provide electronic access to SDSs, therefore ``amending
the HCS to permit use of QR codes on labels for SDSs would not
materially alter the standard's requirement for SDSs but would
encourage use of the technology'' (Document ID 0334, p. 5).
HCPA supported OSHA's exploration of the HCS permitting electronic
labeling in some situations. They stated that the product identifier,
pictograms, and hazard statements should remain on labels affixed to
the product, but employers should be able to convey other aspects
digitally. In their view, this would allow employees to access the most
important information in the event of an emergency, but they could
still have ready access to the rest of the information. They
specifically noted that it would facilitate employee access to SDSs in
the case of an electrical failure. Additionally, HCPA stated that
manufacturers and importers should still have labels online with
complete information that can be downloaded, printed, and applied to
containers when the employer cannot access information digitally
(Document ID 0327, p. 6). Similarly, ADM supported the use of
electronic labeling to provide enhanced safety information and reduce
label sizes, but suggested that essential information should still be
required on printed labels, including signal words and hazard
statements, in the event of a power failure or for businesses not fully
equipped with the latest technologies (Document ID 0361, p. 3).
NACD stated that use of electronic labels and SDSs could benefit
small packages and emergency responders, but requiring the use of
electronic devices might present challenges because, among other
things, some employers do not allow workers to use cell phones, there
would need to be a standard format across operating systems, and
network accessibility is not universal (Document ID 0329, p. 9).
ACC supported the use of electronic labeling for chemical packaging
and particularly supported the distribution of SDSs via electronic
means. However, ACC noted a number of issues would need to be clarified
in order to determine whether it would be realistic to incorporate
electronic labeling in the HCS, including what would be considered an
electronic label, whether it would only add to the label or replace
elements of the label, and whether it would apply to the label or the
SDS. ACC also raised concerns about using electronic devices in
restricted areas due to potential fire hazards. Additionally, ACC
requested clarification on how these changes would be coordinated with
maintaining the pertinent data online for products. ACC suggested that
OSHA provide clarification on the timing of OSHA's adoption of
electronic labeling and create a working group rather than attempting
to address the issue in this rulemaking (Document ID 0347, pp. 20-21).
Similarly, Dow raised concerns regarding the potential fire and
explosion hazards that would occur if unrated electronic devices such
as cell phones were used in ``electrically classified areas'' to read
electronic labels. Dow also stated that codes would have to link to a
website to access the label information, which can be challenging for
companies to maintain and update for extended periods at the same web
address. Further, workers might be unable to access important safety
information on the label if a company fails to maintain its website due
to the company restructuring or shutting down. For these reasons, Dow
suggested that electronic labeling should only be voluntary (Document
ID 0359, pp. 6-7).
OSHA appreciates commenters providing information on electronic
labeling. OSHA is not proposing any new changes in this rulemaking on
this issue, but the agency will consider these comments and concerns in
future discussions at the UN and in future HCS revisions.
List of Subjects in 29 CFR Part 1910
Chemicals, Diseases, Explosives, Flammable materials, Gases,
Hazardous substances, Incorporation by reference, Labeling,
Occupational safety and health, Safety, Signs and symbols.
Authority and Signature
This document was prepared under the direction of Douglas L.
Parker, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor, 200 Constitution Avenue NW,
Washington, DC 20210. It is issued under the authority of sections 4,
6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C.
653, 655, 657); 5 U.S.C. 553; section 304, Clean Air Act Amendments of
1990 (Pub. L. 101-549, reprinted at 29 U.S.C.A. 655 Note); section 41,
Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); section
107, Contract Work Hours and Safety Standards Act (40 U.S.C. 3704);
section 1031, Housing and Community Development Act of 1992 (42 U.S.C.
4853); section 126, Superfund Amendments and Reauthorization Act of
1986, as amended (reprinted at 29 U.S.C.A. 655 Note); Secretary of
Labor's Order No. 8-2020 (85 FR 58393-94); and 29 CFR part 1911.
Signed at Washington, DC.
Douglas L. Parker,
Assistant Secretary of Labor for Occupational Safety and Health.
For the reasons set forth in the preamble, Chapter XVII of Title
29, part 1910 of the Code of Federal Regulations is amended as follows:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS
0
1. The authority citation for part 1910 continues to read as follows:
Authority: 33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754); 8-76 (41 FR 25059), 9-83 (48
FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), 1-2012 (77 FR 3912), or 08-2020 (85 FR 58393); 29 CFR part
1911; and 5 U.S.C. 553, as applicable.
0
2. Amend Sec. 1910.6 as follows:
0
a. Revise paragraph (a), the introductory text of paragraph (e), and
the introductory text of paragraph (h);
0
b. Redesignate paragraphs (h)(27) and (28) as (h)(28) and (29) and add
new paragraph (h)(27);
0
c. Redesignate paragraphs n through (bb) as shown in the following
redesignation table:
------------------------------------------------------------------------
Old paragraph New paragraph
------------------------------------------------------------------------
n......................................... p.
o......................................... s.
p through x............................... t through bb.
y......................................... o.
z......................................... cc.
aa........................................ r.
bb........................................ dd.
------------------------------------------------------------------------
0
d. Add new paragraphs (n) and (q); and
0
e. Revise newly redesignated paragraphs (v) and (dd).
The revisions and additions read as follows:
Sec. 1910.6 Incorporation by Reference.
(a)(1) Certain material is incorporated by reference into this part
with the approval of the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other
than that specified in this section, the Occupational Safety and Health
Administration (OSHA) must publish a document in the Federal Register
and the material must be available to the public.
(i) The standards of agencies of the U.S. Government, and
organizations which are not agencies of the U.S. Government which are
incorporated by reference in this part, have the same force and effect
as other standards in this part. Only the mandatory provisions (i.e.,
provisions containing the word ``shall'' or other mandatory language)
of standards incorporated by reference are adopted as standards under
the Occupational Safety and Health Act.
(ii) Any changes in the standards incorporated by reference in this
part and an official historic file of such changes are available for
inspection in the Docket Office at the national office of OSHA, U.S.
Department of Labor, Washington, DC 20210; telephone: 202-693-2350 (TTY
number: 877-889-5627).
(2) All approved incorporation by reference (IBR) material is
available for inspection at OSHA and at the National Archives and
Records Administration (NARA).
(i) Contact OSHA at any Regional Office of the Occupational Safety
and Health Administration (OSHA), or at the OSHA Docket Office, U.S.
Department of Labor, 200 Constitution Avenue NW, Room N-3508,
Washington, DC 20210; telephone: 202-693-2350 (TTY number: 877-889-
5627).
(ii) For information on the availability of these standards at
NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or
email fr.inspection@nara.gov.
(3) The IBR material may be obtained from the sources in the
following paragraphs of this section or from one or more private
resellers listed in this paragraph (a)(3). For material that is no
longer commercially available, contact OSHA (see paragraph (a)(2)(i) of
this section).
(i) Accuris Standards Store, 321 Inverness Drive, South Englewood,
CO 80112; phone: (800) 332-6077; website: https://store.accuristech.com.
(ii) American National Standards Institute (see paragraph (e) for
contact information).
(iii) GlobalSpec, 257 Fuller Road, Suite NFE 1100, Albany, NY
12203-3621; phone: (800) 261-2052; website: https://standards.globalspec.com.
(iv) Nimonik Document Center, 401 Roland Way, Suite 224, Oakland,
CA 94624; phone (650)591-7600; email: center.com info@document-center.com;
website: www.document-center.com.
(v) Techstreet, phone: (855) 999-9870; email: store@techstreet.com;
website: www.techstreet.com.
* * * * *
(e) American National Standards Institute (ANSI), 25 West 43rd
Street, Fourth Floor, New York, NY 10036-7417; phone: (212) 642-4980;
email: info@ansi.org; website: www.ansi.org.
* * * * *
(h) ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West
Conshohocken, PA 19428-2959; phone: (610) 832-9585; email:
sevice@astm.org; website: www.astm.org. (27) ASTM D4359-90, Standard
Test Method for Determining Whether a Material is a Liquid or a Solid,
approved July 1, 2019; IBR approved for Sec. 1910.1200.
* * * * *
(27) ASTM D 4359-90, Standard Test Method for Determining Whether a
Material is a Liquid or a Solid, Approved 2019, IBR approved for Sec.
1910.1200.
* * * * *
(n) German Institute for Standardization (DIN) (Beuth Verlag GmbH)
Am DIN-Platz Burggrafenstra[szlig]e 6 10787 Berlin, Germany; phone: +49
30 58885 70070; website: https://din.de/en/about-standards/buy-standard.
(1) DIN 51794:2003-05--Determining the ignition temperature of
petroleum products, May 2003, IBR approved for appendix B to Sec.
1910.1200.
(2) [Reserved]
* * * * *
(q) International Electrotechnical Commission (IEC), IEC
Secretariat, 3 rue de Varemb[eacute], PO Box 131, CH-1211 Geneva 20,
Switzerland; phone: +41 22 919 02 11; email: sales@iec.ch; website:
https://www.iec.ch.
(1) IEC 60079-20-1, Explosive atmospheres--Part 20-1: Material
characteristics for gas and vapor classification--Test methods and
data, Edition 1.0, 2010-01; IBR approved for appendix B to Sec.
1910.1200.
(2) [Reserved]
* * * * *
(v) International Organization for Standardization (ISO), ISO
Central Secretariat, Chemin de Blandonnet 8 CP 401--1214 Vernier,
Geneva, Switzerland; phone: +41 22 749 01 11; email: central@iso.org;
website: www.iso.org/store.html.
(1) ISO 817:2014(E), Refrigerants--Designation and safety
classification, Third edition, 2014-04-15; IBR approved for appendix B
to Sec. 1910.1200.
(2) ISO 10156:1996 (E), Gases and Gas Mixtures--Determination of
Fire Potential and Oxidizing Ability for the Selection of Cylinder
Valve Outlets, Second Edition, Feb. 15, 1996; IBR approved for appendix
B to Sec. 1910.1200.
(3) ISO 10156:2017(E), Gas Cylinders--Gases and gas mixtures--
Determination of fire potential and oxidizing ability for the selection
of cylinder valve outlets, Fourth edition, 2017-07; IBR approved for
appendix B to Sec. 1910.1200.
(4) ISO 10156-2:2005 (E), Gas cylinders--Gases and Gas Mixtures--
Part 2: Determination of Oxidizing Ability of Toxic and Corrosive Gases
and Gas Mixtures, First Edition, Aug. 1, 2005; IBR approved for
appendix B to subpart Z.
(5) ISO 13943:2000 (E/F); Fire Safety--Vocabulary, First Edition,
April, 15, 2000, IBR approved for appendix B to Sec. 1910.1200.
* * * * *
(dd) United Nations (UN), United Nations Publications, P.O. Box 960
Herndon, VA 20172; phone: (703) 661-1571;; email:
order@un.org;
website: https://shop.un.org/.
(1) ADR 2019, European Agreement Concerning the International
Carriage of Dangerous Goods by Road; Annex A: General provisions and
provisions concerning dangerous substances and articles; (Volumes I and
II) including December 2018 corrigendum to Volume II, applicable
January 1, 2019; IBR approved for Sec. 1910.1200.
(2) ST/SG/AC.10/Rev.4 (``UN ST/SG/AC.10/Rev.4''), The UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests
and Criteria, Fourth Revised Edition, 2003; IBR approved for appendix B
to Sec. 1910.1200.
(3) ST/SG/AC.10/11/Rev.6 (``UN ST/SG/AC.10/11/Rev.6''),
Recommendations on the Transport of
Dangerous Goods: Manual of Tests and Criteria, sixth revised edition,
copyright 2015; IBR approved for appendix B to Sec. 1910.1200.
0
3. Amend Sec. 1910.1200 as follows:
0
a. Revise paragraphs (a)(1) and (b)(6)(x);
0
b. Revise and republish paragraph (c);
0
c. Revise paragraphs (d)(1), (e)(4), (f)(1), (5), and (11);
0
d. Add paragraph (f)(12); and
0
e. Revise paragraphs (g)(1) and (2), (7) and (10), (i)(1) through (3),
(j), and appendices A through D.
The revisions and additions read as follows:
Sec. 1910.1200 Hazard Communication Standard.
(a) * * *
(1) The purpose of this section is to ensure that the hazards of
all chemicals produced or imported are classified, and that information
concerning the classified hazards is transmitted to employers and
employees. The requirements of this section are intended to be
consistent with the provisions of the United Nations Globally
Harmonized System of Classification and Labeling of Chemicals (GHS),
primarily Revision 7. The transmittal of information is to be
accomplished by means of comprehensive hazard communication programs,
which are to include container labeling and other forms of warning,
safety data sheets and employee training.
* * * * *
(b) * * *
(6) * * *
(x) Nuisance particulates where the chemical manufacturer or
importer can establish that they do not pose any physical hazard,
health hazard, or other hazards covered under this section;
* * * * *
(c) Article means a manufactured item other than a fluid or
particle:
(i) Which is formed to a specific shape or design during
manufacture;
(ii) Which has end use function(s) dependent in whole or in part
upon its shape or design during end use; and
(iii) Which under normal conditions of use does not release more
than very small quantities, e.g., minute or trace amounts of a
hazardous chemical (as determined under paragraph (d) of this section),
and does not pose a physical hazard or health risk to employees.
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, or designee.
Bulk shipment means any hazardous chemical transported where the
mode of transportation comprises the immediate container (i.e.
contained in tanker truck, rail car, or intermodal container).
Chemical means any substance, or mixture of substances.
Chemical manufacturer means an employer with a workplace where
chemical(s) are produced for use or distribution.
Chemical name means the scientific designation of a chemical in
accordance with the nomenclature system developed by the International
Union of Pure and Applied Chemistry (IUPAC) or the Chemical Abstracts
Service (CAS) rules of nomenclature, or a name that will clearly
identify the chemical for the purpose of conducting a hazard
classification.
Classification means to identify the relevant data regarding the
hazards of a chemical; review those data to ascertain the hazards
associated with the chemical; and decide whether the chemical will be
classified as hazardous according to the definition of hazardous
chemical in this section. In addition, classification for health and
physical hazards includes the determination of the degree of hazard,
where appropriate, by comparing the data with the criteria for health
and physical hazards.
Combustible dust means finely divided solid particulates of a
substance or mixture that pose a flash-fire hazard or explosion hazard
when dispersed in air or other oxidizing media.
Commercial account means an arrangement whereby a retail
distributor sells hazardous chemicals to an employer, generally in
large quantities over time and/or at costs that are below the regular
retail price.
Common name means any designation or identification such as code
name, code number, trade name, brand name or generic name used to
identify a chemical other than by its chemical name.
Container means any bag, barrel, bottle, box, can, cylinder, drum,
reaction vessel, storage tank, or the like that contains a hazardous
chemical. For purposes of this section, pipes or piping systems, and
engines, fuel tanks, or other operating systems in a vehicle, are not
considered to be containers.
Designated representative means any individual or organization to
whom an employee gives written authorization to exercise such
employee's rights under this section. A recognized or certified
collective bargaining agent shall be treated automatically as a
designated representative without regard to written employee
authorization.
Director means the Director, National Institute for Occupational
Safety and Health, U.S. Department of Health and Human Services, or
designee.
Distributor means a business, other than a chemical manufacturer or
importer, which supplies hazardous chemicals to other distributors or
to employers.
Employee means a worker who may be exposed to hazardous chemicals
under normal operating conditions or in foreseeable emergencies.
Workers such as office workers or bank tellers who encounter hazardous
chemicals only in non-routine, isolated instances are not covered.
Employer means a person engaged in a business where chemicals are
either used, distributed, or are produced for use or distribution,
including a contractor or subcontractor.
Exposure or exposed means that an employee is subjected in the
course of employment to a hazardous chemical, and includes potential
(e.g., accidental or possible) exposure. ``Subjected'' in terms of
health hazards includes any route of entry (e.g., inhalation,
ingestion, skin contact or absorption.)
Foreseeable emergency means any potential occurrence such as, but
not limited to, equipment failure, rupture of containers, or failure of
control equipment which could result in an uncontrolled release of a
hazardous chemical into the workplace.
Gas means a substance which
(i) At 122 [deg]F (50 [deg]C) has a vapor pressure greater than
43.51 PSI (300 kPa) (absolute); or
(ii) Is completely gaseous at 68 [deg]F (20 [deg]C) at a standard
pressure of 14.69 PSI (101.3 kPa).
Hazard category means the division of criteria within each hazard
class, e.g., oral acute toxicity and flammable liquids include four
hazard categories. These categories compare hazard severity within a
hazard class and should not be taken as a comparison of hazard
categories more generally.
Hazardous chemical means any chemical which is classified as a
physical hazard or a health hazard, a simple asphyxiant, combustible
dust, or hazard not otherwise classified.
Hazard class means the nature of the physical or health hazards,
e.g., flammable solid, carcinogen, oral acute toxicity.
Hazard not otherwise classified (HNOC) means an adverse physical or
health effect identified through evaluation of scientific evidence
during the classification process that does not meet the specified
criteria for the physical and health hazard classes addressed in this
section. This does not extend coverage to adverse physical and health
effects for which there is a hazard
class addressed in this section, but the effect either falls below the
cut-off value/concentration limit of the hazard class or is under a GHS
hazard category that has not been adopted by OSHA (e.g., acute toxicity
Category 5).
Hazard statement means a statement assigned to a hazard class and
category that describes the nature of the hazard(s) of a chemical,
including, where appropriate, the degree of hazard.
Health hazard means a chemical which is classified as posing one of
the following hazardous effects: acute toxicity (any route of
exposure); skin corrosion or irritation; serious eye damage or eye
irritation; respiratory or skin sensitization; germ cell mutagenicity;
carcinogenicity; reproductive toxicity; specific target organ toxicity
(single or repeated exposure); or aspiration hazard. The criteria for
determining whether a chemical is classified as a health hazard are
detailed in Appendix A to Sec. 1910.1200--Health Hazard Criteria.
Immediate outer package means the first package enclosing the
container of hazardous chemical.
Immediate use means that the hazardous chemical will be under the
control of and used only by the person who transfers it from a labeled
container and only within the work shift in which it is transferred.
Importer means the first business with employees within the Customs
Territory of the United States which receives hazardous chemicals
produced in other countries for the purpose of supplying them to
distributors or employers within the United States.
Label means an appropriate group of written, printed or graphic
information elements concerning a hazardous chemical that is affixed
to, printed on, or attached to the immediate container of a hazardous
chemical, or to the outside packaging.
Label elements means the specified pictogram, hazard statement,
signal word and precautionary statement for each hazard class and
category.
Liquid means a substance or mixture which at 122 [deg]F (50 [deg]C)
has a vapor pressure of not more than 43.51 PSI (300 kPa (3 bar)),
which is not completely gaseous at 68 [deg]F (20 [deg]C) and at a
standard pressure of 101.3 kPa, and which has a melting point or
initial melting point of 68 [deg]F (20 [deg]C) or less at a standard
pressure of 14.69 PSI (101.3 kPa). Either ASTM D4359-90 (R2019)
(incorporated by reference, see Sec. 1910.6); or the test for
determining fluidity (penetrometer test) prescribed in section 2.3.4 of
ADR 2019 (incorporated by reference, see Sec. 1910.6) can establish
whether a viscous substance or mixture is a liquid if a specific
melting point cannot be determined.
Mixture means a combination or a solution composed of two or more
substances in which they do not react.
Physical hazard means a chemical that is classified as posing one
of the following hazardous effects: explosive; flammable (gases,
liquids, or solids); aerosols; oxidizer (gases, liquids, or solids);
self-reactive; pyrophoric (liquid or solid); self-heating; organic
peroxide; corrosive to metal; gas under pressure; in contact with water
emits flammable gas; or desensitized explosive. The criteria for
determining whether a chemical is classified as a physical hazard are
detailed in appendix B to this section.
Physician or other licensed health care professional (PLHCP) means
an individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows the individual to independently
provide or be delegated the responsibility to provide some or all of
the health care services referenced in paragraph (i) of this section.
Pictogram means a composition that may include a symbol plus other
graphic elements, such as a border, background pattern, or color, that
is intended to convey specific information about the hazards of a
chemical. Eight pictograms are designated under this standard for
application to a hazard category.
Precautionary statement means a phrase that describes recommended
measures that should be taken to minimize or prevent adverse effects
resulting from exposure to a hazardous chemical, or improper storage or
handling.
Produce means to manufacture, process, formulate, blend, extract,
generate, emit, or repackage.
Product identifier means the name or number used for a hazardous
chemical on a label or in the SDS. It provides a unique means by which
the user can identify the chemical. The product identifier used shall
permit cross-references to be made among the list of hazardous
chemicals required in the written hazard communication program, the
label and the SDS.
Released for shipment means a chemical that has been packaged and
labeled in the manner in which it will be distributed or sold.
Responsible party means someone who can provide additional
information on the hazardous chemical and appropriate emergency
procedures, if necessary.
Safety data sheet (SDS) means written or printed material
concerning a hazardous chemical that is prepared in accordance with
paragraph (g) of this section.
Signal word means a word used to indicate the relative level of
severity of hazard and alert the reader to a potential hazard on the
label. The signal words used in this section are ``danger'' and
``warning.'' ``Danger'' is used for the more severe hazards, while
``warning'' is used for the less severe.
Simple asphyxiant means a substance or mixture that displaces
oxygen in the ambient atmosphere, and can thus cause oxygen deprivation
in those who are exposed, leading to unconsciousness and death.
Solid means a substance or mixture which does not meet the
definitions of liquid or gas.
Specific chemical identity means the chemical name, Chemical
Abstracts Service (CAS) Registry Number, or any other information that
reveals the precise chemical designation of the substance.
Substance means chemical elements and their compounds in the
natural state or obtained by any production process, including any
additive necessary to preserve the stability of the product and any
impurities deriving from the process used, but excluding any solvent
which may be separated without affecting the stability of the substance
or changing its composition.
Trade secret means any confidential formula, pattern, process,
device, information or compilation of information that is used in an
employer's business, and that gives the employer an opportunity to
obtain an advantage over competitors who do not know or use it.
Appendix E to Sec. 1910.1200--Definition of Trade Secret, sets out the
criteria to be used in evaluating trade secrets.
Use means to package, handle, react, emit, extract, generate as a
byproduct, or transfer.
Work area means a room or defined space in a workplace where
hazardous chemicals are produced or used, and where employees are
present.
Workplace means an establishment, job site, or project, at one
geographical location containing one or more work areas.
(d)(1)(i) Chemical manufacturers and importers shall evaluate
chemicals produced in their workplaces or imported by them to classify
the chemicals in accordance with this section. For each chemical, the
chemical manufacturer or importer shall determine the hazard classes,
and where appropriate, the category of each class
that apply to the chemical being classified. The hazard classification
shall include any hazards associated with the chemical's intrinsic
properties including:
(A) a change in the chemical's physical form and;
(B) chemical reaction products associated with known or reasonably
anticipated uses or applications.
(ii) Employers are not required to classify chemicals unless they
choose not to rely on the classification performed by the chemical
manufacturer or importer for the chemical to satisfy this paragraph
(d)(1).
* * * * *
(e) * * *
(4) The employer shall make the written hazard communication
program available, upon request, to employees, their designated
representatives, the Assistant Secretary and the Director, in
accordance with the requirements of Sec. 1910.1020(e).
* * * * *
(f) * * *
(1) Labels on shipped containers. The chemical manufacturer,
importer, or distributor shall ensure that each container of hazardous
chemicals leaving the workplace is labeled, tagged or marked. Hazards
not otherwise classified and hazards identified and classified under
(d)(1)(ii) do not have to be addressed on the container. Where the
chemical manufacturer, importer, or distributor is required to label,
tag or mark the following shall be provided:
(i) Product identifier;
(ii) Signal word;
(iii) Hazard statement(s);
(iv) Pictogram(s);
(v) Precautionary statement(s);
(vi) Name, U.S. address, and U.S. telephone number of the chemical
manufacturer, importer, or other responsible party.
* * * * *
(5) Transportation. (i) Chemical manufacturers, importers, or
distributors shall ensure that each container of hazardous chemicals
leaving the workplace is labeled, tagged, or marked in accordance with
this section in a manner which does not conflict with the requirements
of the Hazardous Materials Transportation Act (49 U.S.C. 5101 et seq.)
and regulations issued under that Act by the Department of
Transportation (49 CFR subtitle B).
(ii) The label for bulk shipments of hazardous chemicals must be on
the immediate container, transmitted with the shipping papers or the
bills of lading, or, with the agreement of the receiving entity,
transmitted by technological or electronic means so that it is
immediately available to workers in printed form on the receiving end
of shipment.
(iii) Where a pictogram required by the Department of
Transportation under title 49 of the Code of Federal Regulations
appears on a shipped container, the pictogram specified in appendix C.4
to this section for the same hazard is not required on the label.
* * * * *
(11) Label Updates. (i) Chemical manufacturers, importers,
distributors, or employers who become newly aware of any significant
information regarding the hazards of a chemical shall revise the labels
for the chemical within six months of becoming aware of the new
information, and shall ensure that labels on containers of hazardous
chemicals shipped after that time contain the new information. For
chemicals that have been released for shipment and are awaiting future
distribution, chemical manufacturers, importers, distributors, or
employers have the option not to relabel those containers; however, if
they do not relabel the containers, they must either provide the
updated label for each individual container with each shipment or, with
the agreement of the receiving entity, transmit the labels by
electronic or other technological means.
(ii) If the chemical is not currently produced or imported, the
chemical manufacturer, importer, distributor, or employer shall add the
information to the label before the chemical is shipped or introduced
into the workplace again.
(12) Small container labelling. (i) This paragraph applies where
the chemical manufacturer, importer, or distributor can demonstrate
that it is not feasible to use pull-out labels, fold-back labels, or
tags containing the full label information required by paragraph (f)(1)
of this section.
(ii) For a container less than or equal to 100 ml capacity, the
chemical manufacturer, importer, or distributor must include, at a
minimum, the following information on the label of the container:
(A) Product identifier;
(B) Pictogram(s);
(C) Signal word;
(D) Chemical manufacturer's name and phone number; and
(E) A statement that the full label information for the hazardous
chemical is provided on the immediate outer package.
(iii) For a container less than or equal to 3 ml capacity, where
the chemical manufacturer, importer, or distributor can demonstrate
that any label interferes with the normal use of the container, no
label is required, but the container must bear, at a minimum, the
product identifier.
(iv) For all small containers covered by paragraph (f)(12)(ii) or
(iii) of this section, the immediate outer package must include:
(A) The full label information required by paragraph (f)(1) of this
section for each hazardous chemical in the immediate outer package. The
label must not be removed or defaced, as required by paragraph (f)(9)
of this section.
(B) A statement that the small container(s) inside must be stored
in the immediate outer package bearing the complete label when not in
use.
(g) Safety data sheets. (1) Chemical manufacturers and importers
shall obtain or develop a safety data sheet for each hazardous chemical
they produce or import. Employers shall have a safety data sheet in the
workplace for each hazardous chemical which they use.
(2) The chemical manufacturer or importer shall ensure that the
safety data sheet is in English (although the employer may maintain
copies in other languages as well), and includes at least the following
section numbers and headings, and associated information under each
heading, in the order listed (see appendix D to this section, for the
specific content of each section of the safety data sheet):
(i) Section 1, Identification;
(ii) Section 2, Hazard(s) identification;
(iii) Section 3, Composition/information on ingredients;
(iv) Section 4, First-aid measures;
(v) Section 5, Fire-fighting measures;
(vi) Section 6, Accidental release measures;
(vii) Section 7, Handling and storage;
(viii) Section 8, Exposure controls/personal protection;
(ix) Section 9, Physical and chemical properties;
(x) Section 10, Stability and reactivity;
(xi) Section 11, Toxicological information.
(xii) Section 12, Ecological information;
(xiii) Section 13, Disposal considerations;
(xiv) Section 14, Transport information;
(xv) Section 15, Regulatory information; and
(xvi) Section 16, Other information, including date of preparation
or last revision.
Note 1 to paragraph (g)(2): To be consistent with the GHS, an
SDS must also include the headings in paragraphs (g)(2)(xii) through
(g)(2)(xv) of this section in order.
Note 2 to paragraph (g)(2): OSHA will not be enforcing
information requirements in
sections 12 through 15, as these areas are not under its
jurisdiction.
* * * * *
(7)(i) Distributors shall ensure that safety data sheets, and
updated information, are provided to other distributors and employers
with their initial shipment and with the first shipment after a safety
data sheet is updated;
(ii) The distributor shall either provide safety data sheets with
the shipped containers, or send them to the other distributor or
employer prior to or at the time of the shipment;
(iii) Retail distributors selling hazardous chemicals to employers
having a commercial account shall provide a safety data sheet to such
employers upon request, and shall post a sign or otherwise inform them
that a safety data sheet is available;
(iv) Wholesale distributors selling hazardous chemicals to
employers over-the-counter may also provide safety data sheets upon the
request of the employer at the time of the over-the-counter purchase,
and shall post a sign or otherwise inform such employers that a safety
data sheet is available;
(v) If an employer without a commercial account purchases a
hazardous chemical from a retail distributor not required to have
safety data sheets on file (i.e., the retail distributor does not have
commercial accounts and does not use the materials), the retail
distributor shall provide the employer, upon request, with the name,
address, and telephone number of the chemical manufacturer, importer,
or distributor from which a safety data sheet can be obtained;
(vi) Wholesale distributors shall also provide safety data sheets
to employers or other distributors upon request; and,
(vii) Chemical manufacturers, importers, and distributors need not
provide safety data sheets to retail distributors that have informed
them that the retail distributor does not sell the product to
commercial accounts or open the sealed container to use it in their own
workplaces.
* * * * *
(10) Safety data sheets may be kept in any form, including as
operating procedures, and may be stored in such a way to cover groups
of hazardous chemicals in a work area where it may be more appropriate
to address the hazards of a process rather than individual hazardous
chemicals. However, the employer shall ensure that in all cases the
required information is provided for each hazardous chemical, and is
readily accessible during each work shift to employees when they are in
their work area(s).
* * * * *
(i) Trade secrets. (1) The chemical manufacturer, importer, or
employer may withhold the specific chemical identity, including the
chemical name, other specific identification of a hazardous chemical,
and/or the exact percentage (concentration) or concentration range of
the substance in a mixture, from section 3 of the safety data sheet,
provided that:
(i) The claim that the information withheld is a trade secret can
be supported;
(ii) Information contained in the safety data sheet concerning the
properties and effects of the hazardous chemical is disclosed;
(iii) The safety data sheet indicates that the specific chemical
identity and/or concentration or concentration range of composition is
being withheld as a trade secret;
(iv) If the concentration or concentration range is being claimed
as a trade secret then the safety data sheet provides the ingredient's
concentration as one of the prescribed ranges below in paragraphs
(i)(1)(iv)(A) through (M) of this section.
(A) from 0.1% to 1%;
(B) from 0.5% to 1.5%;
(C) from 1% to 5%;
(D) from 3% to 7%;
(E) from 5% to 10%;
(F) from 7% to 13%;
(G) from 10% to 30%;
(H) from 15% to 40%;
(I) from 30% to 60%;
(J) from 45% to 70%;
(K) from 60% to 80%;
(L) from 65% to 85%; and
(M) from 80% to 100%.
(v) The prescribed concentration range used must be the narrowest
range possible. If the exact concentration range falls between 0.1% and
30% and does not fit entirely into one of the prescribed concentration
ranges of paragraphs (i)(1)(iv)(A) to (G) of this section, a single
range created by the combination of two applicable consecutive ranges
between paragraphs (i)(1)(iv)(A) and (G) of this section may be
disclosed instead, provided that the combined concentration range does
not include any range that falls entirely outside the exact
concentration range in which the ingredient is present.
(vi) Manufacturers may provide a range narrower than those
prescribed in (i)(1)(v).
(vii) The specific chemical identity and exact concentration or
concentration range is made available to health professionals,
employees, and designated representatives in accordance with the
applicable provisions of this paragraph (i) of this section.
(2) Where a treating PLHCP determines that a medical emergency
exists and the specific chemical identity and/or specific concentration
or concentration range of a hazardous chemical is necessary for
emergency or first-aid treatment, the chemical manufacturer, importer,
or employer shall immediately disclose the specific chemical identity
or percentage composition of a trade secret chemical to that treating
PLHCP, regardless of the existence of a written statement of need or a
confidentiality agreement. The chemical manufacturer, importer, or
employer may require a written statement of need and confidentiality
agreement, in accordance with the provisions of paragraphs (i)(3) and
(4) of this section, as soon as circumstances permit.
(3) In non-emergency situations, a chemical manufacturer, importer,
or employer shall, upon request, disclose a specific chemical identity
or exact concentration or concentration range, otherwise permitted to
be withheld under paragraph (i)(1) of this section, to a health
professional (e.g., PLHCP, industrial hygienist, toxicologist, or
epidemiologist) providing medical or other occupational health services
to exposed employee(s), and to employees or designated representatives,
if:
(i) The request is in writing;
(ii) The request describes with reasonable detail one or more of
the following occupational health needs for the information:
(A) To assess the hazards of the chemicals to which employees will
be exposed;
(B) To conduct or assess sampling of the workplace atmosphere to
determine employee exposure levels;
(C) To conduct pre-assignment or periodic medical surveillance of
exposed employees;
(D) To provide medical treatment to exposed employees;
(E) To select or assess appropriate personal protective equipment
for exposed employees;
(F) To design or assess engineering controls or other protective
measures for exposed employees; and,
(G) To conduct studies to determine the health effects of exposure.
(iii) The request explains in detail why the disclosure of the
specific chemical identity or percentage composition is essential and
that, in lieu thereof, the disclosure of the following information to
the health professional, employee, or designated representative,
would not satisfy the purposes described in paragraph (i)(3)(ii) of
this section:
(A) The properties and effects of the chemical;
(B) Measures for controlling workers' exposure to the chemical;
(C) Methods of monitoring and analyzing worker exposure to the
chemical; and,
(D) Methods of diagnosing and treating harmful exposures to the
chemical;
(iv) The request includes a description of the procedures to be
used to maintain the confidentiality of the disclosed information; and,
(v) The health professional, and the employer or contractor of the
services of the health professional (i.e. downstream employer, labor
organization, or individual employee), employee, or designated
representative, agree in a written confidentiality agreement that the
health professional, employee, or designated representative, will not
use the trade secret information for any purpose other than the health
need(s) asserted and agree not to release the information under any
circumstances other than to OSHA, as provided in paragraph (i)(6) of
this section, except as authorized by the terms of the agreement or by
the chemical manufacturer, importer, or employer.
* * * * *
(j) Dates--(1) Effective date. This section shall become effective
July 19, 2024.
(2) Substances. (i) Manufacturers, importers, and distributors,
evaluating substances shall be in compliance with all modified
provisions of this section no later than January 19, 2026.
(ii) For substances, all employers shall, as necessary, update any
alternative workplace labeling used under paragraph (f)(6) of this
section, update the hazard communication program required by paragraph
(h)(1) of this section, and provide any additional employee training in
accordance with paragraph (h)(3) of this section for newly identified
physical hazard, or health hazards or other hazards covered under this
section no later than July 20, 2026.
(3) Mixtures. (i) Chemical manufacturers, importers, and
distributors evaluating mixtures shall be in compliance with all
modified provisions of this section no later than July 19, 2027.
(ii) For mixtures, all employers shall, as necessary, update any
alternative workplace labeling used under paragraph (f)(6) of this
section, update the hazard communication program required by paragraph
(h)(1) of this section, and provide any additional employee training in
accordance with paragraph (h)(3) of this section for newly identified
physical hazards, health hazards, or other hazards covered under this
section no later than January 19, 2028.
(4) Compliance. Between May 20, 2024 and the dates specified in
paragraphs (j)(2) and (3) of this section, as applicable, chemical
manufacturers, importers, distributors, and employers may comply with
either this section or Sec. 1910.1200 revised as of July 1, 2023, or
both during the transition period.
Appendix A to Sec. 1910.1200--Health Hazard Criteria (Mandatory)
A.0 General Classification Considerations
A.0.1 Classification
A.0.1.1 The term ``hazard classification'' is used to indicate
that only the intrinsic hazardous properties of chemicals are
considered. Hazard classification incorporates three steps:
(a) Identification of relevant data regarding the hazards of a
chemical;
(b) Subsequent review of those data to ascertain the hazards
associated with the chemical;
(c) Determination of whether the chemical will be classified as
hazardous and the degree of hazard.
A.0.1.2 For many hazard classes, the criteria are semi-
quantitative or qualitative and expert judgment is required to
interpret the data for classification purposes.
A.0.1.3 Where impurities, additives or individual constituents
of a substance or mixture have been identified and are themselves
classified, they should be taken into account during classification
if they exceed the cut-off value/concentration limit for a given
hazard class.
A.0.2 Available Data, Test Methods and Test Data Quality
A.0.2.1 There is no requirement for testing chemicals.
A.0.2.2 The criteria for determining health hazards are test
method neutral, i.e., they do not specify particular test methods,
as long as the methods are scientifically validated.
A.0.2.3 The term ``scientifically validated'' refers to the
process by which the reliability and the relevance of a procedure
are established for a particular purpose. Any test that determines
hazardous properties, which is conducted according to recognized
scientific principles, can be used for purposes of a hazard
determination for health hazards. Test conditions need to be
standardized so that the results are reproducible with a given
substance, and the standardized test yields ``valid'' data for
defining the hazard class of concern.
A.0.2.4 Existing test data are acceptable for classifying
chemicals, although expert judgment also may be needed for
classification purposes.
A.0.2.5 The effect of a chemical on biological systems is
influenced, by the physico-chemical properties of the substance and/
or ingredients of the mixture and the way in which ingredient
substances are biologically available. A chemical need not be
classified when it can be shown by conclusive experimental data from
scientifically validated test methods that the chemical is not
biologically available.
A.0.2.6 For classification purposes, epidemiological data and
experience on the effects of chemicals on humans (e.g., occupational
data, data from accident databases) shall be taken into account in
the evaluation of human health hazards of a chemical.
A.0.3 Classification Based on Weight of Evidence
A.0.3.1 For some hazard classes, classification results directly
when the data satisfy the criteria. For others, classification of a
chemical shall be determined on the basis of the total weight of
evidence using expert judgment. This means that all available
information bearing on the classification of hazard shall be
considered together, including the results of valid in vitro tests,
relevant animal data, and human experience such as epidemiological
and clinical studies and well-documented case reports and
observations.
A.0.3.2 The quality and consistency of the data shall be
considered. Information on chemicals related to the material being
classified shall be considered as appropriate, as well as site of
action and mechanism or mode of action study results. Both positive
and negative results shall be considered together in a single
weight-of-evidence determination.
A.0.3.3 Positive effects which are consistent with the criteria
for classification, whether seen in humans or animals, shall
normally justify classification. Where evidence is available from
both humans and animals and there is a conflict between the
findings, the quality and reliability of the evidence from both
sources shall be evaluated in order to resolve the question of
classification. Reliable, good quality human data shall generally
have precedence over other data. However, even well-designed and
conducted epidemiological studies may lack a sufficient number of
subjects to detect relatively rare but still significant effects, or
to assess potentially confounding factors. Therefore, positive
results from well-conducted animal studies are not necessarily
negated by the lack of positive human experience but require an
assessment of the robustness, quality and statistical power of both
the human and animal data.
A.0.3.4 Route of exposure, mechanistic information, and
metabolism studies are pertinent to determining the relevance of an
effect in humans. When such information raises doubt about relevance
in humans, a lower classification may be warranted. When there is
scientific evidence demonstrating that the mechanism or mode of
action is not relevant to humans, the chemical should not be
classified.
A.0.3.5 Both positive and negative results are considered
together in the weight of evidence determination. However, a single
positive study performed according to good scientific principles and
with statistically and biologically significant positive results may
justify classification.
A.0.4 Considerations for the Classification of Mixtures
A.0.4.1 Except as provided in A.0.4.2, the process of
classification of mixtures is based on the following sequence:
(a) Where test data are available for the complete mixture, the
classification of the mixture will always be based on those data;
(b) Where test data are not available for the mixture itself,
the bridging principles designated in each health hazard chapter of
this appendix shall be considered for classification of the mixture;
(c) If test data are not available for the mixture itself, and
the available information is not sufficient to allow application of
the above-mentioned bridging principles, then the method(s)
described in each chapter for estimating the hazards based on the
information known will be applied to classify the mixture (e.g.,
application of cut-off values/concentration limits).
A.0.4.2 An exception to the above order or precedence is made
for Carcinogenicity, Germ Cell Mutagenicity, and Reproductive
Toxicity. For these three hazard classes, mixtures shall be
classified based upon information on the ingredient substances,
unless on a case-by-case basis, justification can be provided for
classifying based upon the mixture as a whole. See A.5, A.6, and A.7
of this section for further information on case-by-case bases.
A.0.4.3 Use of cut-off values/concentration limits
A.0.4.3.1 When classifying an untested mixture based on the
hazards of its ingredients, cut-off values/concentration limits for
the classified ingredients of the mixture are used for several
hazard classes. While the adopted cut-off values/concentration
limits adequately identify the hazard for most mixtures, there may
be some that contain hazardous ingredients at lower concentrations
than the specified cut-off values/concentration limits that still
pose an identifiable hazard. There may also be cases where the cut-
off value/concentration limit is considerably lower than the
established non-hazardous level for an ingredient.
A.0.4.3.2 If the classifier has information that the hazard of
an ingredient will be evident (i.e., it presents a health risk)
below the specified cut-off value/concentration limit, the mixture
containing that ingredient shall be classified accordingly.
A.0.4.3.3 In exceptional cases, conclusive data may demonstrate
that the hazard of an ingredient will not be evident (i.e., it does
not present a health risk) when present at a level above the
specified cut-off value/concentration limit(s). In these cases the
mixture may be classified according to those data. The data must
exclude the possibility that the ingredient will behave in the
mixture in a manner that would increase the hazard over that of the
pure substance. Furthermore, the mixture must not contain
ingredients that would affect that determination.
A.0.4.4 Synergistic or antagonistic effects
When performing an assessment in accordance with these
requirements, the evaluator must take into account all available
information about the potential occurrence of synergistic effects
among the ingredients of the mixture. Lowering classification of a
mixture to a less hazardous category on the basis of antagonistic
effects may be done only if the determination is supported by
sufficient data.
A.0.5 Bridging Principles for the Classification of Mixtures Where
Test Data Are Not Available for the Complete Mixture
A.0.5.1 Where the mixture itself has not been tested to
determine its toxicity, but there are sufficient data on both the
individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data shall be used in
accordance with the following bridging principles, subject to any
specific provisions for mixtures for each hazard class. These
principles ensure that the classification process uses the available
data to the greatest extent possible in characterizing the hazards
of the mixture.
A.0.5.1.1 Dilution
For mixtures classified in accordance with A.1 through A.10 of
this Appendix, if a tested mixture is diluted with a diluent that
has an equivalent or lower toxicity classification than the least
toxic original ingredient, and which is not expected to affect the
toxicity of other ingredients, then:
(a) The new diluted mixture shall be classified as equivalent to
the original tested mixture; or
(b) For classification of acute toxicity in accordance with A.1
of this Appendix, paragraph A.1.3.6 (the additivity formula) shall
be applied.
A.0.5.1.2 Batching
For mixtures classified in accordance with A.1 through A.10 of
this Appendix, the toxicity of a tested production batch of a
mixture can be assumed to be substantially equivalent to that of
another untested production batch of the same mixture, when produced
by or under the control of the same chemical manufacturer, unless
there is reason to believe there is significant variation such that
the toxicity of the untested batch has changed. If the latter
occurs, a new classification is necessary.
A.0.5.1.3 Concentration of mixtures
For mixtures classified in accordance with A.1, A.2, A.3, A.4,
A.8, A.9, or A.10 of this Appendix, if a tested mixture is
classified in Category 1, and the concentration of the ingredients
of the tested mixture that are in Category 1 is increased, the
resulting untested mixture shall be classified in Category 1.
A.0.5.1.4 Interpolation within one hazard category
For mixtures classified in accordance with A.1, A.2, A.3, A.4,
A.8, A.9, or A.10 of this Appendix, for three mixtures (A, B and C)
with identical ingredients, where mixtures A and B have been tested
and are in the same hazard category, and where untested mixture C
has the same toxicologically active ingredients as mixtures A and B
but has concentrations of toxicologically active ingredients
intermediate to the concentrations in mixtures A and B, then mixture
C is assumed to be in the same hazard category as A and B.
A.0.5.1.5 Substantially similar mixtures
For mixtures classified in accordance with A.1 through A.10 of
this Appendix, given the following set of conditions:
(a) Where there are two mixtures:
(i) A + B;
(ii) C + B;
(b) The concentration of ingredient B is essentially the same in
both mixtures;
(c) The concentration of ingredient A in mixture (i) equals that
of ingredient C in mixture (ii);
(d) And data on toxicity for A and C are available and
substantially equivalent; i.e., they are in the same hazard category
and are not expected to affect the toxicity of B; then
If mixture (i) or (ii) is already classified based on test data,
the other mixture can be assigned the same hazard category.
A.0.5.1.6 Aerosols
For mixtures classified in accordance with A.1, A.2, A.3, A.4,
A.8, or A.9 of this Appendix, an aerosol form of a mixture shall be
classified in the same hazard category as the tested, non-
aerosolized form of the mixture, provided the added propellant does
not affect the toxicity of the mixture when spraying.
A.1 Acute Toxicity
A.1.1 Definition
Acute toxicity refers to serious adverse health effects (i.e.,
lethality) occurring after a single or short-term oral, dermal, or
inhalation exposure to a substance or mixture.
A.1.2 Classification Criteria for Substances
A.1.2.1 Substances can be allocated to one of four hazard
categories based on acute toxicity by the oral, dermal or inhalation
route according to the numeric cut-off criteria as shown in Table
A.1.1. Acute toxicity values are expressed as (approximate) LD50
(oral, dermal) or LC50 (inhalation) values or as acute
toxicity estimates (ATE). While some in vivo methods determine LD50/
LC50 values directly, other newer in vivo methods (e.g., using fewer
animals) consider other indicators of acute toxicity, such as
significant clinical signs of toxicity, which are used by reference
to assign the hazard category. See the footnotes following Table
A.1.1 for further explanation on the application of these values.
Table A.1.1--Acute Toxicity Estimate (ATE) Values and Criteria for Acute Toxicity Hazard Categories
----------------------------------------------------------------------------------------------------------------
Exposure route Category 1 Category 2 Category 3 Category 4
----------------------------------------------------------------------------------------------------------------
Oral (mg/kg bodyweight) see:
Note (a).................... ATE <= 5.......... >5 ATE <= 50...... >50 ATE <= 300.... >300 ATE <= 2000.
Note (b)....................
Dermal (mg/kg bodyweight) see:
Note (a).................... ATE <= 5.......... >50 ATE <= 200.... >200 ATE <= 1000.. >1000 ATE <= 2000.
Note (b)....................
Inhalation--Gases (ppmV) see:
Note (a).................... ATE <= 100........ >100 ATE <= 500... >500 ATE <= 2500.. >2500 ATE <=
20000.
Note (b)....................
Note (c)....................
Inhalation--Vapors (mg/l) see:
Note (a).................... ATE <= 0.5........ >0.5 ATE <= 2.0... >2.0 ATE <= 10.0.. >10.0 ATE <= 20.0.
Note (b)....................
Note (c)....................
Note (d)....................
Inhalation--Dusts and Mists (mg/
l) see:
Note (a).................... ATE <= 0.05....... >0.05 ATE <= 0.5.. >0.5 ATE <= 1.0... >1.0 ATE <= 5.0.
Note (b)....................
Note (c)....................
----------------------------------------------------------------------------------------------------------------
Note: Gas concentrations are expressed in parts per million per volume (ppmV). Notes to Table A.1.1:
(a) The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50 where
available.
(b) The acute toxicity estimate (ATE) for the classification of a substance or ingredient in a mixture is
derived using:
(i) the LD50/LC50 where available. Otherwise,
(ii) the appropriate conversion value from Table 1.2 that relates to the results of a range test, or
(iii) the appropriate conversion value from Table 1.2 that relates to a classification category;
(c) Inhalation cut-off values in the table are based on 4 hour testing exposures. Conversion of existing
inhalation toxicity data which has been generated according to 1 hour exposure is achieved by dividing by a
factor of 2 for gases and vapors and 4 for dusts and mists;
(d) For some substances the test atmosphere will be a vapor which consists of a combination of liquid and
gaseous phases. For other substances the test atmosphere may consist of a vapor which is nearly all the
gaseous phase. In these latter cases, classification is based on ppmV as follows: Category 1 (100 ppmV),
Category 2 (500 ppmV), Category 3 (2500 ppmV), Category 4 (20000 ppmV).
The terms ``dust'', ``mist'' and ``vapor'' are defined as follows:
(i) Dust: solid particles of a substance or mixture suspended in a gas (usually air);
(ii) Mist: liquid droplets of a substance or mixture suspended in a gas (usually air);
(iii) Vapor: the gaseous form of a substance or mixture released from its liquid or solid state.
A.1.2.3 The preferred test species for evaluation of acute
toxicity by the oral and inhalation routes is the rat, while the rat
or rabbit are preferred for evaluation of acute dermal toxicity.
Test data already generated for the classification of chemicals
under existing systems should be accepted when reclassifying these
chemicals under the harmonized system. When experimental data for
acute toxicity are available in several animal species, scientific
judgment should be used in selecting the most appropriate
LD50 value from among scientifically validated tests. In
cases where data from human experience (i.e., occupational data,
data from accident databases, epidemiology studies, clinical
reports) is also available, it should be considered in a weight of
evidence approach consistent with the principles described in A.0.3.
A.1.2.4 In addition to classification for inhalation toxicity,
if data are available that indicates that the mechanism of toxicity
was corrosivity of the substance or mixture, the classifier must
consider if the chemical is corrosive to the respiratory tract.
Corrosion of the respiratory tract is defined as destruction of the
respiratory tract tissue after a single, limited period of exposure
analogous to skin corrosion; this includes destruction of the
mucosa. The corrosivity evaluation could be based on expert judgment
using such evidence as: human and animal experience, existing (in
vitro) data, Ph values, information from similar substances or any
other pertinent data.
A.1.2.4.1 If the classifier determines the chemical is corrosive
to the respiratory tract and data are available that indicate that
the effect leads to lethality, then in addition to the appropriate
acute toxicity pictogram and hazard statement, the chemical must be
labelled with the hazard statement ``corrosive to the respiratory
tract'' and the corrosive pictogram.
A.1.2.4.2 If the classifier determines the chemical is corrosive
to the respiratory tract and the effect does not lead to lethality,
then the chemical must be addressed in the Specific Target Organ
Toxicity hazard classes (see A.8). If data is insufficient for
classification under STOT, but the classifier determines, based on
skin or eye data, that the chemical may be corrosive to the
respiratory tract, then the hazard must be addressed using data for
classification in the skin corrosion/irritation hazard class (see
A.2) or Serious Eye Damage/Eye irritation hazard class (see A.3).
A.1.3 Classification Criteria for Mixtures
A.1.3.1 The approach to classification of mixtures for acute
toxicity is tiered, and is dependent upon the amount of information
available for the mixture itself and for its ingredients. The flow
chart of Figure A.1.1 indicates the process that must be followed:
A.1.1 Figure--1 Tiered Approach to Classification of Mixtures for Acute
Toxicity
[GRAPHIC] [TIFF OMITTED] TR20MY24.223
A.1.3.2 Classification of mixtures for acute toxicity may be
carried out for each route of exposure, but is only required for one
route of exposure as long as this route is followed (estimated or
tested) for all ingredients and there is no relevant evidence to
suggest acute toxicity by multiple routes. When there is relevant
evidence of acute toxicity by multiple routes of exposure,
classification is to be conducted for all appropriate routes of
exposure. All available information shall be considered. The
pictogram and signal word used shall reflect the most severe hazard
category; and all relevant hazard statements shall be used.
A.1.3.3 For purposes of classifying the hazards of mixtures in
the tiered approach:
(a) The ``relevant ingredients'' of a mixture are those which
are present in concentrations >=1% (weight/weight for solids,
liquids, dusts, mists and vapors and volume/volume for gases). If
there is reason to suspect that an ingredient present at a
concentration <1% will affect classification of the mixture for
acute toxicity, that ingredient shall also be considered relevant.
Consideration of ingredients present at a concentration <1% is
particularly important when classifying untested mixtures which
contain ingredients that are classified in Category 1 and Category
2;
(b) Where a classified mixture is used as an ingredient of
another mixture, the actual or derived acute toxicity estimate (ATE)
for that mixture is used when calculating the classification of the
new mixture using the formulas in A.1.3.6.1 and A.1.3.6.2.4.
(c) If the converted acute toxicity point estimates for all
ingredients of a mixture are within the same category, then the
mixture should be classified in that category.
(d) When only range data (or acute toxicity hazard category
information) are available for ingredients in a mixture, they may be
converted to point estimates in accordance with Table A.1.2 when
calculating the classification of the new mixture using the formulas
in A.1.3.6.1 and A.1.3.6.2.4.
A.1.3.4 Classification of mixtures where acute toxicity test
data are available for the complete mixture
Where the mixture itself has been tested to determine its acute
toxicity, it is classified according to the same criteria as those
used for substances, presented in Table A.1.1. If test data for the
mixture are not available, the procedures presented below must be
followed.
A.1.3.5 Classification of mixtures where acute toxicity test
data are not available for the complete mixture: bridging principles
Where the mixture itself has not been tested to determine its
acute toxicity, but there are sufficient data on both the individual
ingredients and similar tested mixtures to adequately characterize
the hazards of the mixture, these data will be used in accordance
with the following bridging principles as found in paragraph A.0.5
of this Appendix: Dilution, Batching, Concentration of mixtures,
Interpolation within one hazard category, Substantially similar
mixtures, and Aerosols.
A.1.3.6 Classification of mixtures based on ingredients of the
mixture (additivity formula)
A.1.3.6.1 Data available for all ingredients.
The acute toxicity estimate (ATE) of ingredients is considered
as follows:
(a) Include ingredients with a known acute toxicity, which fall
into any of the acute hazard categories, or have an oral or dermal
LD50 greater than 2000 but less than or equal to 5000 mg/
kg body weight (or the equivalent dose for inhalation);
(b) Ignore ingredients that are presumed not acutely toxic
(e.g., water, sugar);
(c) Ignore ingredients if the data available are from a limit
dose test (at the upper threshold for Category 4 for the appropriate
route of exposure as provided in Table A.1.1) and do not show acute
toxicity.
Ingredients that fall within the scope of this paragraph are
considered to be ingredients with a known acute toxicity estimate
(ATE). See note (b) to Table A.1.1 and paragraph A.1.3.3 for
appropriate application of available data to the equation below, and
paragraph A.1.3.6.2.4.
The ATE of the mixture is determined by calculation from the ATE
values for all relevant ingredients according to the following
formula below for oral, dermal or inhalation toxicity:
[GRAPHIC] [TIFF OMITTED] TR20MY24.224
Where:
Ci = concentration of ingredient i;
n ingredients and i is running from 1 to n;
ATEi = Acute toxicity estimate of ingredient i;
A.1.3.6.2 Data are not available for one or more ingredients of
the mixture.
A.1.3.6.2.1 Where an ATE is not available for an individual
ingredient of the mixture, but available information provides a
derived conversion value, the formula in A.1.3.6.1 may be applied.
This information may include evaluation of:
(a) Extrapolation between oral, dermal and inhalation acute
toxicity estimates. Such an evaluation requires appropriate
pharmacodynamic and pharmacokinetic data;
(b) Evidence from human exposure that indicates toxic effects
but does not provide lethal dose data;
(c) Evidence from any other toxicity tests/assays available on
the substance that indicates toxic acute effects but does not
necessarily provide lethal dose data; or
(d) Data from closely analogous substances using structure/
activity relationships.
A.1.3.6.2.2 This approach requires substantial supplemental
technical information, and a highly trained and experienced expert,
to reliably estimate acute toxicity. If sufficient information is
not available to reliably estimate acute toxicity, proceed to the
provisions of A.1.3.6.2.4.
A.1.3.6.2.3 In the event that an ingredient with unknown acute
toxicity is used in a mixture at a concentration >=1%, and the
mixture has not been classified based on testing of the mixture as a
whole, the mixture cannot be attributed a definitive acute toxicity
estimate. In this situation the mixture is classified based on the
known ingredients only.
Note: A statement that x percent of the mixture consists of
ingredient(s) of unknown acute (oral/dermal/inhalation) toxicity is
required on the label and safety data sheet in such cases; see
appendix C to this section, Allocation of Label Elements and
appendix D to this section, Safety Data Sheets).
A.1.3.6.2.4 If the total concentration of the relevant
ingredient(s) with unknown acute toxicity is <=10% then the formula
presented in A.1.3.6.1 must be used. If the total concentration of
the relevant ingredient(s) with unknown acute toxicity is <=10%, the
formula presented in A.1.3.6.1 is corrected to adjust for the
percentage of the unknown ingredient(s) as follows:
[GRAPHIC] [TIFF OMITTED] TR20MY24.225
Table A.1.2--Conversion From Experimentally Obtained Acute Toxicity
Range Values (or Acute Toxicity Hazard Categories) to Acute Toxicity
Point Estimates for Use in the Formulas for the Classification of
Mixtures
------------------------------------------------------------------------
Classification
category or
experimentally Converted
Exposure routes obtained acute acute toxicity
toxicity range point estimate
estimate
------------------------------------------------------------------------
Oral (mg/kg bodyweight)........... 0 < Category 1 <= 5. 0.5
5 < Category 2 <= 50 5
50 < Category 3 <= 100
300.
300 < Category 4 <= 500
2000.
Dermal (mg/kg bodyweight)......... 0 < Category 1 <= 50 5
50 < Category 2 <= 50
200.
200 < Category 3 <= 300
1000.
1000 < Category 4 <= 1100
2000.
Gases (ppmV)...................... 0 < Category 1 <= 10
100.
100 < Category 2 <= 100
500.
500 < Category 3 <= 700
2500.
2500 < Category 4 <= 4500
20000.
Vapors (mg/l)..................... 0 < Category 1 <= 0.05
0.5.
0.5 < Category 2 <= 0.5
2.0.
2.0 < Category 3 <= 3
10.0.
10.0 < Category 4 <= 11
20.0.
Dust/mist (mg/l).................. 0 < Category 1 <= 0.005
0.05.
0.05 < Category 2 <= 0.05
0.5.
0.5 < Category 3 <= 0.5
1.0.
1.0 < Category 4 <= 1.5
5.0.
------------------------------------------------------------------------
Note: Gas concentrations are expressed in parts per million per volume
(ppmV).
A.2 Skin Corrosion/Irritation
A.2.1 Definitions and General Considerations
A.2.1.1 Skin corrosion refers to the production of irreversible
damage to the skin; namely, visible necrosis through the epidermis
and into the dermis occurring after initial exposure to a substance
or mixture.
Skin irritation refers to the production of reversible damage to
the skin occurring after initial exposure to a substance or mixture.
A.2.1.2 To classify, all available and relevant information on
skin corrosion/irritation is collected and its quality in terms of
adequacy and reliability is assessed. Wherever possible
classification should be based on data generated using
internationally validated and accepted methods, such as OECD Test
Guidelines (TG) or equivalent methods. Sections A.2.2.1 to A.2.2.6
provide classification criteria for the different types of
information that may be available.
A.2.1.3 A tiered approach (see A.2.2.7) organizes the available
information into levels/tiers and provides for decision-making in a
structured and sequential manner. Classification results directly
when the information consistently satisfies the criteria. However,
where the available information gives inconsistent and/or
conflicting results within a tier, classification of a substance or
a mixture is made on the basis of the weight of evidence within that
tier. In some cases when information from different tiers gives
inconsistent and/or conflicting results (see A.2.2.7.3) or where
data individually are insufficient to conclude on the
classification, an overall weight of evidence approach is used (see
A.0.3).
A.2.2 Classification Criteria for Substances
Substances shall be allocated to one of the following categories
within this hazard class:
(a) Category 1 (skin corrosion)
This category may be further divided into up to three sub-
categories (1A, 1B, and 1C), which can be used by those authorities
requiring more than one designation for corrosivity.
Corrosive substances should be classified in Category 1 where
sub-categorization is not required by a competent authority or where
data are not sufficient for sub-categorization.
When data are sufficient, substances may be classified in one of
the three sub-categories 1A, 1B, or 1C.
(b) Category 2 (skin irritation)
A.2.2.1 Classification Based on Standard Human Data
Existing reliable and good quality human data on skin corrosion/
irritation should be given high weight for classification. Existing
human data could be derived from single or repeated exposure(s), for
example in occupational, consumer, transport or emergency response
scenarios and
epidemiological and clinical studies in well-documented case reports
and observations (see A.0.2.6 and A.0.3). Although human data from
accident or poison center databases can provide evidence for
classification, absence of incidents is not itself evidence for no
classification, as exposures are generally unknown or uncertain.
A.2.2.2 Classification Based on Standard Animal Test Data
OECD TG 404 is the currently available internationally validated
and accepted animal test for classification as skin corrosive or
irritant (See Table A.2.1 and A.2.2) and is the standard animal
test. The current version of OECD TG 404 uses a maximum of 3
animals. Results from animal studies conducted under previous
versions of OECD TG 404 that used more than 3 animals are also
considered standard animal tests.
A.2.2.2.1 Skin Corrosion
A.2.2.2.1.1 A substance is corrosive to the skin when it
produces destruction of skin tissue, namely, visible necrosis
through the epidermis and into the dermis, in at least one tested
animal after initial exposure up to a 4-hour duration.
A.2.2.2.1.2 Three sub-categories of Category 1 are provided in
Table A.2.1, all of which shall be regulated as Category 1.
Table A.2.1--Skin Corrosion Category and Sub-Categories \a\
----------------------------------------------------------------------------------------------------------------
Criteria
----------------------------------------------------------------------------------------------------------------
Category 1..................................... Destruction of skin tissue, namely, visible necrosis through
the epidermis and into the dermis, in at least one tested
animal after exposure <=4 h.
Sub-category 1A................................ Corrosive responses in at least one animal following exposure
<=3 min during an observation period <=1 h.
Sub-category 1B................................ Corrosive responses in at least one animal following exposure
>3 min and <=1 h and observations <=14 days.
Sub-category 1C................................ Corrosive responses in at least one animal after exposures >1 h
and <= 4 h and observations <=14 days.
----------------------------------------------------------------------------------------------------------------
\a\ The use of human data is discussed in A.2.2.1.
A.2.2.2.2 Skin Irritation
A.2.2.2.2.1 A substance is irritant to skin when it produces
reversible damage to the skin following its application for up to 4
hours.
A.2.2.2.2.2 A single irritant category (Category 2) is presented
in the Table A.2.2. A substance is irritant to skin, when after the
first application, it produces reversible damage to the skin
following its application for up to 4 hours. An irritation category
(Category 2) is provided that:
(a) recognizes that some test substances may lead to effects
which persist throughout the length of the test; and
(b) acknowledges that animal responses in a test may be
variable.
A.2.2.2.2.3 Reversibility of skin lesions is another
consideration in evaluating irritant responses. When inflammation
persists to the end of the observation period in two or more test
animals, taking into consideration alopecia (limited area),
hyperkeratosis, hyperplasia and scaling, then a chemical should be
considered to be an irritant.
A.2.2.2.2.4 Animal irritant responses within a test can be quite
variable, as they are with corrosion. A separate irritant criterion
accommodates cases when there is a significant irritant response but
less than the mean score criterion for a positive test. For example,
a substance should be designated as an irritant if at least 1 of 3
tested animals shows a very elevated mean score according to test
method used throughout the study, including lesions persisting at
the end of an observation period of normally 14 days. Other
responses should also fulfil this criterion. However, it should be
ascertained that the responses are the result of chemical exposure.
Addition of this criterion increases the sensitivity of the
classification system.
Table A.2.2--Skin Irritation Categories \a\
----------------------------------------------------------------------------------------------------------------
Criteria
----------------------------------------------------------------------------------------------------------------
Irritant (Category 2).......................... (1) Mean score of >=2.3 <=4.0 for erythema/eschar or for edema
in at least 2 of 3 testedanimals from gradings at 24, 48, 72
hours after patch removal or, if reactions are delayed, from
grades on 3 consecutive days after the onset of skin
reactions; or
(2) Inflammation that persists to the end of the observation
period normally 14 days in at hyerplasia, and scaling; or
(3) In some cases where there is pronounced variability of
response among animals, with very definite positive effects
related to chemical exposure in a single animal but less than
the criteria above.
----------------------------------------------------------------------------------------------------------------
\a\ Grading criteria are understood as described in OECD Test Guideline 404.
A.2.2.3 Classification Based on In Vitro/Ex Vivo Data
A.2.2.3.1 The currently available individual in vitro/ex vivo
test methods address either skin irritation or skin corrosion, but
do not address both endpoints in one single test. Therefore,
classification based solely on in vitro/ex vivo test results may
require data from more than one method.
A.2.2.3.2 Wherever possible classification should be based on
data generated using internationally validated and accepted in
vitro/ex vivo test methods, and the classification criteria provided
in these test methods needs to be applied. In vitro/ex vivo data can
only be used for classification when the tested substance is within
the applicability domain of the test methods used. Additional
limitations described in the published literature should also be
taken into consideration.
A.2.2.3.3 Skin corrosion
A.2.2.3.3.1 Where tests have been undertaken in accordance with
OECD Test Guidelines (TGs) 430, 431, or 435, a substance is
classified for skin corrosion in category 1 (and, where possible and
required into sub-categories 1A, 1B, or 1C) based on the criteria in
Table A.2.6.
A.2.2.3.3.2 Some in vitro/ex vivo methods do not allow
differentiation between sub-categories 1B and 1C. Where existing in
vitro/ex vivo data cannot distinguish between the sub-categories,
additional information has to be taken into account to differentiate
between these two sub-categories. Where no or insufficient
additional information is available, category 1 is applied.
A.2.2.3.3.3 A substance identified as not corrosive should be
considered for classification as skin irritant.
A.2.2.3.4 Skin irritation
A.2.2.3.4.1 Where a conclusion of corrosivity can be excluded
and where tests have been undertaken in accordance with OECD Test
Guideline 439, a substance is classified for skin irritation in
category 2 based on the criteria in Table A.2.7.
A.2.2.3.4.2 A negative result in an internationally accepted and
validated in vitro/ex vivo test for skin irritation, e.g., OECD TG
439, can be used to conclude as not classified for skin irritation.
A.2.2.4 Classification Based on Other, Existing Skin Data in Animals
Other existing skin data in animals may be used for
classification, but there may be limitations regarding the
conclusions that
can be drawn if a substance is highly toxic via the dermal route, an
in vivo skin corrosion/irritation study may not have been conducted
since the amount of test substance to be applied would considerably
exceed the toxic dose and, consequently, would result in the death
of the animals. When observations of skin corrosion/irritation in
acute toxicity studies are made, these data may be used for
classification, provided that the dilutions used and species tested
are relevant. Solid substances (powders) may become corrosive or
irritant when moistened or in contact with moist skin or mucous
membranes. This is generally indicated in the standardized test
methods.
A.2.2.5 Classification Based on Chemical Properties
Skin effects may be indicated by pH extremes such as <=2 and
>=11.5 especially when associated with significant acid/alkaline
reserve (buffering capacity). Generally, such substances are
expected to produce significant effects on the skin. In the absence
of any other information, a substance is considered corrosive (Skin
Category 1) if it has a pH <=2 or a pH >=11.5. However, if
consideration of acid/alkaline reserve suggests the substance may
not be corrosive despite the low or high pH, this needs to be
confirmed by other data, preferably from an appropriate validated in
vitro/ex vivo test. Buffering capacity and pH can be determined by
test methods including OECD TG 122.
A.2.2.6 Classification Based on Non-Test Methods
A.2.2.6.1 Classification, including non-classification, can be
based on non-test methods, with due consideration of reliability and
applicability, on a case-by-case basis. Such methods include
computer models predicting qualitative structure-activity
relationships (structural alerts, SAR); quantitative structure-
activity relationships (QSARs); computer expert systems; and read-
across using analogue and category approaches.
A.2.2.6.2 Read-across using analogue or category approaches
requires sufficiently reliable test data on similar substance(s) and
justification of the similarity of the tested substance(s) with the
substance(s) to be classified. Where adequate justification of the
read-across approach is provided, it has in general higher weight
than (Q)SARs.
A.2.2.6.3 Classification based on (Q)SARs requires sufficient
data and validation of the model. The validity of the computer
models and the prediction should be assessed using internationally
recognized principles for the validation of (Q)SARs. With respect to
reliability, lack of alerts in a SAR or expert system is not
sufficient evidence for no classification.
A.2.2.7 Classification in a Tiered Approach
A.2.2.7.1 A tiered approach to the evaluation of initial
information should be considered, where applicable (Figure A.2.1),
recognizing that not all elements may be relevant. However, all
available and relevant information of sufficient quality needs to be
examined for consistency with respect to the resulting
classification.
A.2.2.7.2 In the tiered approach (Figure A.2.1), existing human
and animal data form the highest tier, followed by in vitro/ex vivo
data, other existing skin data in animals, and then other sources of
information. Where information from data within the same tier is
inconsistent and/or conflicting, the conclusion from that tier is
determined by a weight of evidence approach.
A.2.2.7.3 Where information from several tiers is inconsistent
and/or conflicting with respect to the resulting classification,
information of sufficient quality from a higher tier is generally
given a higher weight than information from a lower tier. However,
when information from a lower tier would result in a stricter
classification than information from a higher tier and there is
concern for misclassification, then classification is determined by
an overall weight of evidence approach. The same would apply in the
case where there is human data indicating irritation but positive
results from an in vitro/ex vivo test for corrosion.
Figure A.2.1--Application of the Tiered Approach for Skin Corrosion and
Irritation
[GRAPHIC] [TIFF OMITTED] TR20MY24.226
(a) Before applying the approach, the explanatory text in
A.2.2.7 should be consulted. Only adequate and reliable data of
sufficient quality should be included in applying the tiered
approach.
(b) Information may be inconclusive for various reasons, e.g.:
--The available data may be of insufficient quality, or otherwise
insufficient/inadequate for the purpose of classification, e.g., due
to quality issues related to experimental design and/or reporting.
--The available data may be insufficient to conclude on the
classification, e.g., they might be adequate to demonstrate
irritancy, but inadequate to demonstrate absence of corrosivity.
--The method used to generate the available data may not be suitable
for concluding on no classification (see A.2.2. for details).
Specifically, in vitro/ex vivo and non-test methods need to be
validated explicitly for this purpose.
A.2.3 Classification Criteria for Mixtures
A.2.3.1 Classification of Mixtures When Data Are Available for the
Complete Mixture
A.2.3.1.1 In general, the mixture shall be classified using the
criteria for substances, taking into account the tiered approach to
evaluate data for this hazard class (as illustrated in Figure A.2.1)
and A.2.3.1.2 and A.2.3.1.3. If classification is not possible using
the tiered approach, then the approach described in A.2.3.2, or, if
that is not applicable A.2.2.3.3 should be followed.
A.2.3.1.2 In vitro/ex vivo data generated from validated test
methods may not have been validated using mixtures; although these
methods are considered broadly applicable to mixtures, they can only
be used for classification of mixtures when all ingredients of the
mixture fall within the applicability domain of the test methods
used. Specific limitations regarding applicability domains are
described in the respective test methods, and should be taken into
consideration as well as any further information on the limitations
from the published literature. Where there is reason to assume or
evidence indicating that the applicability domain of a particular
test method is limited, data interpretation should be exercised with
caution, or the results should be considered not applicable.
A.2.3.1.3 In the absence of any other information, a mixture is
considered corrosive (Skin Category 1) if it has a pH <=2 or a pH
>=11.5. However, if consideration of acid/alkaline reserve suggests
the mixture may not be corrosive despite the low or high pH value,
this needs to be confirmed by other data, preferably from an
appropriate validated in vitro/ex vivo test.
A.2.3.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.2.3.2.1 Where the mixture itself has not been tested to
determine its skin corrosion/irritation potential, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data will be used in accordance with the following
bridging principles, as found in paragraph A.0.5 of this Appendix:
Dilution, Batching, Concentration of mixtures, Interpolation within
one hazard category, Substantially similar mixtures, and Aerosols.
A.2.3.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.2.3.3.1 In order to make use of all available data for
purposes of classifying the skin corrosion/irritation hazards of
mixtures, the following assumption has been made and is applied
where appropriate in the tiered approach:
The ``relevant ingredients'' of a mixture are those which are
present in concentrations >=1% (weight/weight for solids, liquids,
dusts, mists and vapors and volume/volume for gases.). If the
classifier has reason to suspect that an ingredient present at a
concentration <1% will affect classification of the mixture for skin
corrosion/irritation, that ingredient shall also be considered
relevant.
A.2.3.3.2 In general, the approach to classification of mixtures
as corrosive or irritant to the skin when data are available on the
ingredients, but not on the mixture as a whole, is based on the
theory of additivity, such that each corrosive or irritant
ingredient contributes to the overall corrosive or irritant
properties of the mixture in proportion to its potency and
concentration. A weighting factor of 10 is used for corrosive
ingredients when they are present at a concentration below the
concentration limit for classification with Category 1, but are at a
concentration that will contribute to the classification of the
mixture as an irritant. The mixture is classified as corrosive or
irritant when the sum of the concentrations of such ingredients
exceeds a cut-off value/concentration limit.
A.2.3.3.3 Table A.2.3 below provides the cut-off value/
concentration limits to be used to determine if the mixture is
considered to be corrosive or irritant to the skin.
A.2.3.3.4 Particular care shall be taken when classifying
certain types of chemicals such as acids and bases, inorganic salts,
aldehydes, phenols, and surfactants. The approach explained in
A.2.3.3.1 and A.2.3.3.2 might not work given that many of such
substances are corrosive or irritant at concentrations <1%. For
mixtures containing strong acids or bases the pH should be used as
classification criteria since pH will be a better indicator of
corrosion than the concentration limits in Table A.2.3. A mixture
containing corrosive or irritant ingredients that cannot be
classified based on the additivity approach shown in Table A.2.3,
due to chemical characteristics that make this approach unworkable,
should be classified as skin corrosion Category 1 if it contains
>=1% of a corrosive ingredient and as skin irritation Category 2
when it contains >=3% of an irritant ingredient. Classification of
mixtures with ingredients for which the approach in Table A.2.3 does
not apply is summarized in Table A.2.4 below.
A.2.3.3.5 On occasion, reliable data may show that the skin
corrosion/irritation of an ingredient will not be evident when
present at a level above the generic cut-off values/concentration
limits mentioned in Tables A.2.3 and A.2.4. In these cases the
mixture could be classified according to those data (See Use of cut-
off values/concentration limits, paragraph A.0.4.3 of this
Appendix).
A.2.3.3.6 If there are data showing that (an) ingredient(s) may
be corrosive or irritant to skin at a concentration of <1%
(corrosive) or <3% (irritant), the mixture shall be classified
accordingly (See Use of cut-off values/concentration limits,
paragraph A.0.4.3 of this Appendix).
Table A.2.3--Concentration of Ingredients of a Mixture Classified as
Skin Category 1 or 2 That Would Trigger Classification of the Mixture as
Hazardous to Skin
[Category 1 or 2]
------------------------------------------------------------------------
Concentration triggering classification
of a mixture as:
Sum of ingredients classified ----------------------------------------
as: Skin corrosive Skin irritant
----------------------------------------
Category 1 Category 2
------------------------------------------------------------------------
Skin Category 1................ >=5% >=1% but <5%
Skin Category 2................ .............. >=10%
(10 x Skin Category 1) + Skin .............. >=10%
Category 2.
------------------------------------------------------------------------
Note: Where the sub-categories of skin Category 1 (corrosive) are used,
the sum of all ingredients of a mixture classified as sub-category 1A,
1B or 1C respectively, must each be >=5% in order to classify the
mixture as either skin sub-category 1A, 1B or 1C. Where the sum of 1A
ingredients is <5% but the sum of 1A + 1B ingredients is >=5%, the
mixture must be classified as sub-category 1B. Similarly, where the
sum of 1A + 1B ingredients is <5% but the sum of 1A + 1B + 1C
ingredients is >=5% the mixture must be classified as sub-category 1C.
Where at least one relevant ingredient in a mixture is classified as a
Category 1 categorization, the mixture must be classified as Category
1 without sub-categorization if the sum of all ingredients corrosive
to skin is >=5%.
Table A.2.4--Concentration of Ingredients of a Mixture When the Additivity Approach Does Not Apply, That Would
Trigger Classification of the Mixture as Hazardous to Skin
----------------------------------------------------------------------------------------------------------------
Concentration
Ingredient (percent) Mixture classified as: Skin
----------------------------------------------------------------------------------------------------------------
Acid with pH <=2.............................. >=1 Category 1.
Base with pH >=11.5........................... >=1 Category 1.
Other corrosive (Category 1) ingredient....... >=1 Category 1.
Other irritant (Category 2) ingredient, >= 3 Category 2.
including acids and bases.
----------------------------------------------------------------------------------------------------------------
A.3 Serious Eye Damage/Eye Irritation
A.3.1 Definitions and General Considerations
A.3.1.1 Serious eye damage refers to the production of tissue
damage in the eye, or serious physical decay of vision, which is not
fully reversible, occurring after exposure of the eye to a substance
or mixture.
Eye irritation refers to the production of changes in the eye,
which are fully reversible, occurring after exposure of the eye to a
substance or mixture.
A.3.1.2 Serious eye damage/eye irritation shall be classified
using a tiered approach as detailed in Figure A.3.1. Emphasis shall
be placed upon existing human data (See A.0.2.6), followed by
existing animal data, followed by in vitro data and then other
sources of information. Classification results directly when the
data satisfy the criteria in this section. In case the criteria
cannot be directly applied, classification of a substance or a
mixture is made on the basis of the total weight of evidence (See
A.0.3.1). This means that all available information bearing on the
determination of serious eye damage/eye irritation is considered
together, including the results of appropriate scientifically
validated in vitro tests, relevant animal data, and human data such
as epidemiological and clinical studies and well-documented case
reports and observations.
A.3.2 Classification Criteria for Substances
Substances are allocated to one of the categories within this
hazard class, Category 1 (serious eye damage) or Category 2 (eye
irritation), as follows:
(a) Category 1 (serious eye damage/irreversible effects on the
eye): substances that have the potential to seriously damage the
eyes (see Table A.3.1).
(b) Category 2 (eye irritation/reversible effects on the eye):
substances that have the potential to induce reversible eye
irritation (see Table A.3.2).
A.3.2.1 Classification Based on Standard Animal Test Data
A.3.2.1.1 Serious eye damage (Category 1)/Irreversible effects
on the eye
A single hazard category is provided in Table A.3.1, for
substances that have the potential to seriously damage the eyes.
Category 1, irreversible effects on the eye, includes the criteria
listed below. These observations include animals with grade 4 cornea
lesions and other severe reactions (e.g., destruction of cornea)
observed at any time during the test, as well as persistent corneal
opacity, discoloration of the cornea by a dye substance, adhesion,
pannus, and interference with the function of the iris or other
effects that impair sight. In this context, persistent lesions are
considered those which are not fully reversible within an
observation period of normally 21 days. Category 1 also contains
substances fulfilling the criteria of corneal opacity >= 3 and/or
iritis > 1.5 observed in at least 2 of 3 tested animals detected in
a Draize eye test with rabbits, because severe lesions like these
usually do not reverse within a 21-day observation period.
Table A.3.1--Serious Eye Damage/Irreversible Effects on the Eye Category a
----------------------------------------------------------------------------------------------------------------
Criteria
----------------------------------------------------------------------------------------------------------------
Category 1: Serious eye damage/Irreversible A substance that produces:
effects on the eye. (a) in at least one animal effects on the cornea, iris or
conjunctiva that are not expected to reverse or have not fully
reversed within an observation period of normally 21 days; and/or
(b) in at least 2 of 3 tested animals, a positive response of:
(i) corneal opacity >=3; and/or
(ii) iritis >1.5;
calculated as the mean scores following grading at 24, 48 and 72
hours after instillation of the test material.
----------------------------------------------------------------------------------------------------------------
\a\ Grading criteria are understood as described in OECD Test Guideline 405.
A.3.2.1.2 Eye irritation (category 2)/reversible effects on the
eye
A single Category 2 is provided in Table A.3.2 for substances
that have the potential to induce reversible eye irritation.
When data are available, substances may be classified into
Category 2A and Category 2B:
(a) For substances inducing eye irritant effects reversing
within an observation time of normally 21 days, Category 2A applies.
(b) For substances inducing eye irritant effects reversing
within an observation time of 7 days, Category 2B applies.
When a substance is classified as Category 2, without further
categorization, the classification criteria are the same as those
for 2A.
A.3.2.1.3 For those substances where there is pronounced
variability among animal responses this information must be taken
into account in determining the classification.
Table A.3.2--Reversible Effects on the Eye Categories a
----------------------------------------------------------------------------------------------------------------
Criteria
----------------------------------------------------------------------------------------------------------------
Substances that have the potential to induce reversible eye
irritation.
Category 2/2A............................... Substances that produce in at least 2 of 3 tested animals a
positive response of:
(a) corneal opacity >=1; and/or.
(b) iritis >=1; and/or.
(c) conjunctival redness >=2; and/or.'
(d) conjunctival oedema (chemosis) >=2.
calculated as the mean scores following grading at 24, 48 and 72
hours after instillation of the test material, and which fully
reverses within an observation period of normally 21 days.
Category 2B................................. Within Category 2A an eye irritant is considered mildly irritating
to eyes (Category 2B) when the effects listed above are fully
reversible within 7 days of observation.
----------------------------------------------------------------------------------------------------------------
\a\ Grading criteria are understood as described in OECD Test Guideline 405.
A.3.2.2 Classification in a Tiered Approach
A.3.2.2.1 A tiered approach to the evaluation of initial
information shall be used where applicable, recognizing that all
elements may not be relevant in certain cases (Figure A.3.1).
A.3.2.2.2 Existing human and animal data should be the first
line of analysis, as they give information directly relevant to
effects on the eye. Possible skin corrosion shall be evaluated prior
to consideration of any testing for serious eye damage/eye
irritation in order to avoid testing for local effects on eyes with
skin corrosive substances.
A.3.2.2.3 In vitro alternatives that have been validated and
accepted should be used to make classification decisions.
A.3.2.2.4 Likewise, pH extremes like <=2 and >=11.5, may
indicate serious eye damage, especially when associated with
significant acid/alkaline reserve (buffering capacity). Generally,
such substances are expected to produce significant effects on the
eyes. In the absence of any other information, a substance is
considered to cause serious eye damage (Category 1) if it has a pH
<=2 or >=11.5. However, if consideration of acid/alkaline reserve
suggests the substance may not cause serious eye damage despite the
low or high pH value, this needs to be confirmed by other data,
preferably by data from an appropriate validated in vitro test.
A.3.2.2.5 In some cases sufficient information may be available
from structurally related substances to make classification
decisions.
A.3.2.2.6 The tiered approach provides guidance on how to
organize existing information and to make a weight-of-evidence
decision about hazard assessment and hazard classification (ideally
without conducting new animal tests). Animal testing with corrosive
substances should be avoided wherever possible. Although information
might be gained from the evaluation of single parameters within a
tier, consideration should be given to the totality of existing
information and making an overall weight of evidence determination.
This is especially true when there is conflict in information
available on some parameters.
A.3.2.2.7 The tiered approach explains how to organize existing
information and to make a weight-of-evidence decision about hazard
assessment and hazard classification. Although information might be
gained from the evaluation of single parameters within a tier,
consideration should be given to the totality of existing
information and making an overall weight of evidence determination.
This is especially true when there is conflict in information
available.
BILLING CODE 4510-26-P
Figure A.3.1--Tiered Evaluation for Serious Eye Damage and Eye
Irritation (See Also Figure A.2.1)
[GRAPHIC] [TIFF OMITTED] TR20MY24.227
[GRAPHIC] [TIFF OMITTED] TR20MY24.228
BILLING CODE 4510-26-C
\a\ Existing human or animal data could be derived from single
or repeated exposure(s), for example in occupational, consumer,
transport, or emergency response scenarios; or from purposely-
generated data from animal studies conducted according to validated
and internationally accepted test methods. Although human data from
accident or poison center databases can provide evidence for
classification, absence of incidents is not itself evidence for no
classification as exposures are generally unknown or uncertain;
\b\ Classify in the appropriate category as applicable;
\c\ Existing animal data should be carefully reviewed to
determine if sufficient serious eye damage/eye irritation evidence
is available through other, similar information. It is recognized
that not all skin irritants are eye irritants. Expert judgment
should be exercised prior to making such a determination;
\d\ Evidence from studies using validated protocols with
isolated human/animal tissues or other non-tissue-based, validated
protocols should be assessed. Examples of internationally accepted,
validated test methods for identifying eye corrosives and severe
irritants (i.e., Serious Eye Damage) include OECD Test Guidelines
437 (Bovine Corneal Opacity and Permeability (BCOP)), 438 (Isolated
Chicken Eye (ICE) and 460 (Fluorescein leakage (FL)). Presently
there are no validated and internationally accepted in vitro test
methods for identifying eye irritation. A positive test result from
a validated in vitro test on skin corrosion would lead to the
conclusion to classify as causing serious eye damage;
\e\ Measurement of pH alone may be adequate, but assessment of
acid/alkaline reserve (buffering capacity) would be preferable.
Presently, there is no validated and internationally accepted method
for assessing this parameter;
\f\ All information that is available on a substance must be
considered and an overall determination made on the total weight of
evidence. This is especially true when there is conflict in
information available on some parameters. The weight of evidence
including information on skin irritation may lead to classification
for eye irritation. Negative results from applicable validated in
vitro tests are considered in the total weight of evidence
evaluation.
A.3.3 Classification Criteria for Mixtures
A.3.3.1 Classification of Mixtures When Data Are Available for the
Complete Mixture
A.3.3.1.1 The mixture will be classified using the criteria for
substances, and taking into account the tiered approach to evaluate
data for this hazard class (as illustrated in Figure A.3.1).
A.3.3.1.2 When considering testing of the mixture, chemical
manufacturers shall use a tiered approach as included in the
criteria for classification of substances for skin corrosion and
serious eye damage and eye irritation to help ensure an accurate
classification, as well as to avoid unnecessary animal testing. In
the absence of any other information, a mixture is considered to
cause serious eye damage (Category 1) if it has a pH <=2 or >=11.5.
However, if consideration of acid/alkaline reserve suggests the
mixture may not have the potential to cause serious eye damage
despite the low or high pH value, then further evaluation may be
necessary.
A.3.3.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.3.3.2.1 Where the mixture itself has not been tested to
determine its skin corrosivity or potential to cause serious eye
damage or eye irritation, but there are sufficient data on both the
individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data will be used in
accordance with the following bridging principles, as found in
paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration
of mixtures, Interpolation within one hazard category, Substantially
similar mixtures, and Aerosols.
A.3.3.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.3.3.3.1 For purposes of classifying the serious eye damage/eye
irritation hazards of mixtures in the tiered approach:
The ``relevant ingredients'' of a mixture are those which are
present in concentrations >=1% (weight/weight for solids, liquids,
dusts, mists and vapors and volume/volume for gases.) If the
classifier has reason to suspect that an ingredient present at a
concentration <1% will affect classification of the mixture for
serious eye damage/eye irritation, that ingredient shall also be
considered relevant.
A.3.3.3.2 In general, the approach to classification of mixtures
as seriously damaging to the eye or eye irritant when data are
available on the ingredients, but not on the mixture as a whole, is
based on the theory of additivity, such that each skin corrosive or
serious eye damage/eye irritant ingredient contributes to the
overall serious eye damage/eye irritation properties of the mixture
in proportion to its potency and concentration. A weighting factor
of 10 is used for skin corrosive and serious eye damaging
ingredients when they are present at a concentration below the
concentration limit for classification with Category 1, but are at a
concentration that will contribute to the classification of the
mixture as serious eye damaging/eye irritant. The mixture is
classified as seriously damaging to the eye or eye irritant when the
sum of the concentrations of such ingredients exceeds a threshold
cut-off value/concentration limit.
A.3.3.3.3 Table A.3.3 provides the cut-off value/concentration
limits to be used to determine if the mixture must be classified as
seriously damaging to the eye or an eye irritant.
A.3.3.3.4 Particular care must be taken when classifying certain
types of chemicals such as acids and bases, inorganic salts,
aldehydes, phenols, and surfactants. The
approach explained in A.3.3.3.1 and A.3.3.3.2 might not work given
that many of such substances are seriously damaging to the eye/eye
irritating at concentrations <1%. For mixtures containing strong
acids or bases, the pH should be used as classification criteria
(See A.3.3.1.2) since pH will be a better indicator of serious eye
damage (subject to consideration of acid/alkali reserve) than the
concentration limits of Table A.3.3. A mixture containing skin
corrosive or serious eye damaging/eye irritating ingredients that
cannot be classified based on the additivity approach applied in
Table A.3.3 due to chemical characteristics that make this approach
unworkable, should be classified as serious eye damage (Category 1)
if it contains >=1% of a skin corrosive or serious eye damaging
ingredient and as Eye Irritation (Category 2) when it contains >=3%
of an eye irritant ingredient. Classification of mixtures with
ingredients for which the approach in Table A.3.3 does not apply is
summarized in Table A.3.4.
A.3.3.3.5 On occasion, reliable data may show that the
irreversible/reversible eye effects of an ingredient will not be
evident when present at a level above the generic cut-off values/
concentration limits mentioned in Tables A.3.3 and A.3.4. In these
cases the mixture could be classified according to those data (See
also A.0.4.3 Use of cut-off values/concentration limits''). On
occasion, when it is expected that the skin corrosion/irritation or
the reversible/irreversible eye effects of an ingredient will not be
evident when present at a level above the generic concentration/cut-
off levels mentioned in Tables A.3.3 and A.3.4, testing of the
mixture may be considered. In those cases, the tiered weight of
evidence approach should be applied as referred to in section A.3.2,
Figure A.3.1 and explained in detail in this chapter.
A.3.3.3.6 If there are data showing that (an) ingredient(s) may
be corrosive to the skin or seriously damaging to the eye/eye
irritating at a concentration of <=1% (corrosive to the skin or
seriously damaging to the eye) or <=3% (eye irritant), the mixture
shall be classified accordingly (See also paragraph A.0.4.3, Use of
cut-off values/concentration limits).
Table A.3.3--Concentration of Ingredients of a Mixture Classified as
Skin Category 1 and/or Eye Category 1 or 2 That Would Trigger
Classification of the Mixtures as Hazardous to the Eye
------------------------------------------------------------------------
Concentration triggering classification
of a mixture as
----------------------------------------
Sum of ingredients classified Serious eye Eye irritation
as damage ------------------------
----------------
Category 1 Category 2/2A
------------------------------------------------------------------------
Skin corrosion (Category 1) + >=3% >=1% but <3%
Serious eye damage (Category
1) \a\.
Eye irritation (Category 2).... .............. >=10% \b\
10 x (Skin corrosion (Category .............. >=10%
1) + Serious eye damage
(Category 1)) \a\ + Eye
irritation (Category 2).
------------------------------------------------------------------------
Notes:
\a\ If an ingredient is classified as both skin Category 1 and eye
Category 1 its concentration is considered only once in the
calculation.
\b\ A mixture may be classified as Eye Irritation Category 2B in cases
when all relevant ingredients are classified as Eye Irritation
Category 2B.
Table A.3.4--Concentration of Ingredients of a Mixture for Which the
Additivity Approach Does Not Apply, That Would Trigger Classification of
the Mixture as Hazardous to the Eye
------------------------------------------------------------------------
Concentration Mixture classified
Ingredient (percent) as
------------------------------------------------------------------------
Acid with pH <2................... >=1 Serious eye damage
(Category 1).
Base with pH >=11.5............... >=1 Serious eye damage
(Category 1).
Other skin corrosive or serious >=1 Serious eye damage
eye damage (Category 1) (Category 1).
ingredients.
Other eye irritant (Category 2) >=3 Eye irritation
ingredients. (Category 2).
------------------------------------------------------------------------
A.4 Respiratory or Skin Sensitization
A.4.1 Definitions and General Considerations
A.4.1.1 Respiratory sensitization refers to hypersensitivity of
the airways occurring after inhalation of a substance or mixture.
Skin sensitization refers to an allergic response occurring
after skin contact with a substance or mixture.
A.4.1.2 For the purpose of this chapter, sensitization includes
two phases: the first phase is induction of specialized
immunological memory in an individual by exposure to an allergen.
The second phase is elicitation, i.e., production of a cell-mediated
or antibody-mediated allergic response by exposure of a sensitized
individual to an allergen.
A.4.1.3 For respiratory sensitization, the pattern of induction
followed by elicitation phases is shared in common with skin
sensitization. For skin sensitization, an induction phase is
required in which the immune system learns to react; clinical
symptoms can then arise when subsequent exposure is sufficient to
elicit a visible skin reaction (elicitation phase). As a
consequence, predictive tests usually follow this pattern in which
there is an induction phase, the response to which is measured by a
standardized elicitation phase, typically involving a patch test.
The local lymph node assay is the exception, directly measuring the
induction response. Evidence of skin sensitization in humans
normally is assessed by a diagnostic patch test.
A.4.1.4 Usually, for both skin and respiratory sensitization,
lower levels are necessary for elicitation than are required for
induction.
A.4.1.5 The hazard class ``respiratory or skin sensitization''
is differentiated into:
(a) Respiratory sensitization; and
(b) Skin sensitization
A.4.2 Classification Criteria for Substances
A.4.2.1 Respiratory Sensitizers
A.4.2.1.1 Hazard Categories
A.4.2.1.1.1 Effects seen in either humans or animals will
normally justify classification in a weight of evidence approach for
respiratory sensitizers. Substances may be allocated to one of the
two sub-categories 1A or 1B using a weight of evidence approach in
accordance with the criteria given in Table A.4.1 and on the basis
of reliable and good quality evidence from human cases or
epidemiological studies and/or observations from appropriate studies
in experimental animals.
A.4.2.1.1.2 Where data are not sufficient for sub-
categorization, respiratory sensitizers shall be classified in
Category 1.
Table A.4.1--Hazard Category and Sub-Categories for Respiratory Sensitizers
----------------------------------------------------------------------------------------------------------------
Category 1 Respiratory sensitizer
----------------------------------------------------------------------------------------------------------------
A substance is classified as a respiratory sensitizer
(a) if there is evidence in humans that the substance can lead
to specific respiratory hypersensitivity and/or
(b) if there are positive results from an appropriate animal
test.\1\
Sub-category 1A............................. Substances showing a high frequency of occurrence in humans; or a
probability of occurrence of a high sensitization rate in humans
based on animal or other tests.\1\ Severity of reaction may also
be considered.
Sub-category 1B............................. Substances showing a low to moderate frequency of occurrence in
humans; or a probability of occurrence of a low to moderate
sensitization rate in humans based on animal or other tests.\1\
Severity of reaction may also be considered.
----------------------------------------------------------------------------------------------------------------
A.4.2.1.2 Human Evidence
---------------------------------------------------------------------------
\1\ As of May 20, 2024, recognized and validated animal models
for the testing of respiratory hypersensitivity are not available.
Under certain circumstances, data from animal studies may provide
valuable information in a weight of evidence assessment.
---------------------------------------------------------------------------
A.4.2.1.2.1 Evidence that a substance can lead to specific
respiratory hypersensitivity will normally be based on human
experience. In this context, hypersensitivity is normally seen as
asthma, but other hypersensitivity reactions such as rhinitis/
conjunctivitis and alveolitis are also considered. The condition
will have the clinical character of an allergic reaction. However,
immunological mechanisms do not have to be demonstrated.
A.4.2.1.2.2 When considering the human evidence, it is necessary
that in addition to the evidence from the cases, the following be
taken into account:
(a) The size of the population exposed;
(b) The extent of exposure.
A.4.2.1.3 The evidence referred to above could be:
(a) Clinical history and data from appropriate lung function
tests related to exposure to the substance, confirmed by other
supportive evidence which may include:
(i) In vivo immunological test (e.g., skin prick test);
(ii) In vitro immunological test (e.g., serological analysis);
(iii) Studies that may indicate other specific hypersensitivity
reactions where immunological mechanisms of action have not been
proven, e.g., repeated low-level irritation, pharmacologically
mediated effects;
(iv) A chemical structure related to substances known to cause
respiratory hypersensitivity;
(b) Data from positive bronchial challenge tests with the
substance conducted according to accepted guidelines for the
determination of a specific hypersensitivity reaction.
A.4.2.1.2.4 Clinical history should include both medical and
occupational history to determine a relationship between exposure to
a specific substance and development of respiratory
hypersensitivity. Relevant information includes aggravating factors
both in the home and workplace, the onset and progress of the
disease, family history and medical history of the patient in
question. The medical history should also include a note of other
allergic or airway disorders from childhood and smoking history.
A.4.2.1.2.5 The results of positive bronchial challenge tests
are considered to provide sufficient evidence for classification on
their own. It is, however, recognized that in practice many of the
examinations listed above will already have been carried out.
A.4.2.1.3 Animal studies
A.4.2.1.2.3 Data from appropriate animal studies \2\ which may
be indicative of the potential of a substance to cause sensitization
by inhalation in humans \3\ may include:
---------------------------------------------------------------------------
\2\ At this writing, recognized and validated animal models for
the testing of respiratory hypersensitivity are not available. Under
certain circumstances, data from animal studies may provide valuable
information in a weight of evidence assessment.
\3\ The mechanisms by which substances induce symptoms of asthma
are not yet fully known. For preventive measures, these substances
are considered respiratory sensitizers. However, if on the basis of
the evidence, it can be demonstrated that these substances induce
symptoms of asthma by irritation only in people with bronchial
hyperactivity, they should not be considered as respiratory
sensitizers.
---------------------------------------------------------------------------
(a) Measurements of Immunoglobulin E (IgE) and other specific
immunological parameters, for example in mice
(b) Specific pulmonary responses in guinea pigs.
A.4.2.2 Skin Sensitizers
A.4.2.2.1 Hazard categories
A.4.2.2.1.1 Effects seen in either humans or animals will
normally justify classification in a weight of evidence approach for
skin sensitizers. Substances may be allocated to one of the two sub-
categories 1A or 1B using a weight of evidence approach in
accordance with the criteria given in Table A.4.2 and on the basis
of reliable and good quality evidence from human cases or
epidemiological studies and/or observations from appropriate studies
in experimental animals according to the guidance values provided in
A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 1A and in A.4.2.2.2.2
and A.4.2.2.3.3 for sub-category 1B.
A.4.2.2.1.2 Where data are not sufficient for sub-
categorization, skin sensitizers shall be classified in Category 1.
Table A.4.2--Hazard Category and Sub-Categories for Skin Sensitizers
----------------------------------------------------------------------------------------------------------------
Category 1 Skin sensitizer
----------------------------------------------------------------------------------------------------------------
A substance is classified as a skin sensitizer
(a) if there is evidence in humans that the substance can lead to
sensitization by skin contact in a substantial number of persons,
or
(b) if there are positive results from an appropriate animal test.
Sub-category 1A............................. Substances showing a high frequency of occurrence in humans and/or
a high potency in animals can be presumed to have the potential
to produce significant sensitization in humans. Severity of
reaction may also be considered.
Sub-category 1B............................. Substances showing a low to moderate frequency of occurrence in
humans and/or a low to moderate potency in animals can be
presumed to have the potential to produce sensitization in
humans. Severity of reaction may also be considered.
----------------------------------------------------------------------------------------------------------------
A.4.2.2.2 Human Evidence
A.4.2.2.2.1 Human evidence for sub-category 1A may include:
(a) Positive responses at <=500 [mu]g/cm2 (Human Repeat Insult
Patch Test (HRIPT), Human Maximization Test (HMT)--induction
threshold);
(b) Diagnostic patch test data where there is a relatively high
and substantial incidence of reactions in a defined population in
relation to relatively low exposure;
(c) Other epidemiological evidence where there is a relatively
high and substantial incidence of allergic contact dermatitis in
relation to relatively low exposure.
A.4.2.2.2.2 Human evidence for sub-category 1B may include:
(a) Positive responses at >500 [mu]g/cm2 (HRIPT, HMT--induction
threshold);
(b) Diagnostic patch test data where there is a relatively low
but substantial incidence of reactions in a defined population in
relation to relatively high exposure;
(c) Other epidemiological evidence where there is a relatively
low but substantial incidence of allergic contact dermatitis in
relation to relatively high exposure.
A.4.2.2.3 Animal Studies
A.4.2.2.3.1 For Category 1, when an adjuvant type test method
for skin sensitization is used, a response of at least 30% of the
animals is considered as positive. For a non-adjuvant Guinea pig
test method, a response of at least 15% of the animals is considered
positive. For Category 1, a stimulation index of three or more is
considered a positive response in the local lymph node assay.\4\
---------------------------------------------------------------------------
\4\ Test methods for skin sensitization are described in OECD
Guideline 406 (the Guinea Pig Maximization test and the Buehler
guinea pig test) and Guideline 429 (Local Lymph Node Assay). Other
methods may be used provided that they are scientifically validated.
The Mouse Ear Swelling Test (MEST), appears to be a reliable
screening test to detect moderate to strong sensitizers, and can be
used, in accordance with professional judgment, as a first stage in
the assessment of skin sensitization potential.
---------------------------------------------------------------------------
A.4.2.2.3.2 Animal test results for sub-category 1A can include
data with values indicated in the following Table A.4.3:
Table A.4.3--Animal Test Results for Sub-Category 1A
------------------------------------------------------------------------
Assay Criteria
------------------------------------------------------------------------
Local lymph node assay............ EC3 value <=2%.
Guinea pig maximization test...... >=30% responding at <=0.1%
intradermal induction dose or
>=60% responding at >0.1% to <=1%
intradermal induction dose.
Buehler assay..................... >=15% responding at <=0.2% topical
induction dose or
>=60% responding at >0.2% to <=20%
topical induction dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
required to induce a stimulation index of 3 in the local lymph node
assay.
A.4.2.2.3.3 Animal test results for sub-category 1B can include
data with values indicated in Table A.4.4 below:
Table A.4.4--Animal Test Results for Sub-Category 1B
------------------------------------------------------------------------
Assay Criteria
------------------------------------------------------------------------
Local lymph node assay............ EC3 value >2%.
Guinea pig maximization test...... >=30% to <60% responding at >0.1% to
<=1% intradermal induction dose or
>=30% responding at >1% intradermal
induction dose.
Buehler assay..................... >=15% to <60% responding at >0.2% to
<=20% topical induction dose or
>=15% responding at >20% topical
induction dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
required to induce a stimulation index of 3 in the local lymph node
assay.
A.4.2.2.4 Specific Considerations
A.4.2.2.4.1 For classification of a substance, evidence shall
include one or more of the following using a weight of evidence
approach:
(a) Positive data from patch testing, normally obtained in more
than one dermatology clinic;
(b) Epidemiological studies showing allergic contact dermatitis
caused by the substance. Situations in which a high proportion of
those exposed exhibit characteristic symptoms are to be looked at
with special concern, even if the number of cases is small;
(c) Positive data from appropriate animal studies;
(d) Positive data from experimental studies in humans (See
paragraph A.0.2.6 of this Appendix);
(e) Well documented episodes of allergic contact dermatitis,
normally obtained in more than one dermatology clinic;
(f) Severity of reaction.
A.4.2.2.4.2 Evidence from animal studies is usually much more
reliable than evidence from human exposure. However, in cases where
evidence is available from both sources, and there is conflict
between the results, the quality and reliability of the evidence
from both sources must be assessed in order to resolve the question
of classification on a case-by-case basis. Normally, human data are
not generated in controlled experiments with volunteers for the
purpose of hazard classification but rather as part of risk
assessment to confirm lack of effects seen in animal tests.
Consequently, positive human data on skin sensitization are usually
derived from case-control or other, less defined studies. Evaluation
of human data must, therefore, be carried out with caution as the
frequency of cases reflect, in addition to the inherent properties
of the substances, factors such as the exposure situation,
bioavailability, individual predisposition and preventive measures
taken. Negative human data should not normally be used to negate
positive results from animal studies. For both animal and human
data, consideration should be given to the impact of vehicle.
A.4.2.2.4.3 If none of the above-mentioned conditions are met,
the substance need not be classified as a skin sensitizer. However,
a combination of two or more indicators of skin sensitization, as
listed below, may alter the decision. This shall be considered on a
case-by-case basis.
(a) Isolated episodes of allergic contact dermatitis;
(b) Epidemiological studies of limited power, e.g., where
chance, bias or confounders have not been ruled out fully with
reasonable confidence;
(c) Data from animal tests, performed according to existing
guidelines, which do not meet the criteria for a positive result
described in A.4.2.2.3, but which are sufficiently close to the
limit to be considered significant;
(d) Positive data from non-standard methods;
(e) Positive results from close structural analogues.
A.4.2.2.4.4 Immunological contact urticaria
A.4.2.2.4.4.1 Substances meeting the criteria for classification
as respiratory
sensitizers may, in addition, cause immunological contact urticaria.
Consideration shall be given to classifying these substances as skin
sensitizers.
A.4.2.2.4.4.2 Substances which cause immunological contact
urticaria without meeting the criteria for respiratory sensitizers
shall be considered for classification as skin sensitizers.
A.4.2.2.4.4.3 There is no recognized animal model available to
identify substances which cause immunological contact urticaria.
Therefore, classification will normally be based on human evidence,
similar to that for skin sensitization.
A.4.3 Classification Criteria for Mixtures
A.4.3.1 Classification of Mixtures When Data Are Available for the
Complete Mixture
When reliable and good quality evidence, as described in the
criteria for substances, from human experience or appropriate
studies in experimental animals, is available for the mixture, then
the mixture shall be classified by weight of evidence evaluation of
these data. Care must be exercised in evaluating data on mixtures
that the dose used does not render the results inconclusive.
A.4.3.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.4.3.2.1 Where the mixture itself has not been tested to
determine its sensitizing properties, but there are sufficient data
on both the individual ingredients and similar tested mixtures to
adequately characterize the hazards of the mixture, these data will
be used in accordance with the following agreed bridging principles
as found in paragraph A.0.5 of this Appendix: Dilution, Batching,
Concentration of mixtures, Interpolation within one hazard category/
subcategory, Substantially similar mixtures, and Aerosols.
A.4.3.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
The mixture shall be classified as a respiratory or skin
sensitizer when at least one ingredient has been classified as a
respiratory or skin sensitizer and is present at or above the
appropriate cut-off value/concentration limit for the specific
endpoint as shown in Table A.4.5.
Table A.4.5--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Either Respiratory
Sensitizers or Skin Sensitizers That Would Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
Cut-off values/concentration limits triggering
classification of a mixture as
--------------------------------------------------
Respiratory sensitizer Skin sensitizer
Ingredient classified as Category 1 Category 1
--------------------------------------------------
Solid/liquid All physical
(%) Gas (%) states (%)
----------------------------------------------------------------------------------------------------------------
Respiratory Sensitizer Category 1............................ >=0.1 >=0.1 .................
Respiratory Sensitizer Sub-category 1A....................... >=0.1 >=0.1 .................
Respiratory Sensitizer Sub-category 1B....................... >=1.0 >=0.2 .................
Skin Sensitizer Category 1................................... .............. .............. >=0.1
Skin Sensitizer Sub-category 1A.............................. .............. .............. >=0.1
Skin Sensitizer Sub-category 1B.............................. .............. .............. >=1.0
----------------------------------------------------------------------------------------------------------------
A.5 Germ Cell Mutagenicity
A.5.1 Definitions and General Considerations
A.5.1.1 Germ cell mutagenicity refers to heritable gene
mutations, including heritable structure and numerical chromosome
aberrations in germ cells occurring after exposure to a substance or
mixture.
A.5.1.2 A mutation is defined as a permanent change in the
amount or structure of the genetic material in a cell. The term
mutation applies both to heritable genetic changes that may be
manifested at the phenotypic level and to the underlying DNA
modifications when known (including, for example, specific base pair
changes and chromosomal translocations). The term mutagenic and
mutagen will be used for agents giving rise to an increased
occurrence of mutations in populations of cells and/or organisms.
A.5.1.3 The more general terms genotoxic and genotoxicity apply
to agents or processes which alter the structure, information
content, or segregation of DNA, including those which cause DNA
damage by interfering with normal replication processes, or which in
a non-physiological manner (temporarily) alter its replication.
Genotoxicity test results are usually taken as indicators for
mutagenic effects.
A.5.1.4 This hazard class is primarily concerned with chemicals
that may cause mutations in the germ cells of humans that can be
transmitted to the progeny. However, mutagenicity/genotoxicity tests
in vitro and in mammalian somatic cells in vivo are also considered
in classifying substances and mixtures within this hazard class.
A.5.2 Classification Criteria for Substances
A.5.2.1 The classification system provides for two different
categories of germ cell mutagens to accommodate the weight of
evidence available. The two-category system is described in the
Figure A.5.1.
Figure A.5.1--Hazard Categories for Germ Cell Mutagens
CATEGORY 1: Substances known to induce heritable mutations or to be
regarded as if they induce heritable mutations in the germ cells of
humans
Category 1A: Substances known to induce heritable mutations in germ
cells of humans
Positive evidence from human epidemiological studies.
Category 1B: Substances which should be regarded as if they induce
heritable mutations in the germ cells of humans
(a) Positive result(s) from in vivo heritable germ cell
mutagenicity tests in mammals; or
(b) Positive result(s) from in vivo somatic cell mutagenicity
tests in mammals, in combination with some evidence that the
substance has potential to cause mutations to germ cells. This
supporting evidence may, for example, be derived from mutagenicity/
genotoxic tests in germ cells in vivo, or by demonstrating the
ability of the substance or its metabolite(s) to interact with the
genetic material of germ cells; or
(c) Positive results from tests showing mutagenic effects in the
germ cells of humans, without demonstration of transmission to
progeny; for example, an increase in the frequency of aneuploidy in
sperm cells of exposed people.
CATEGORY 2: Substances which cause concern for humans owing to the
possibility that they may induce heritable mutations in the germ
cells of humans
Positive evidence obtained from experiments in mammals and/or in
some cases from in vitro experiments, obtained from:
(a) Somatic cell mutagenicity tests in vivo, in mammals; or
(b) Other in vivo somatic cell genotoxicity tests which are
supported by positive results from in vitro mutagenicity assays.
Note: Substances which are positive in in vitro mammalian
mutagenicity assays, and which also show structure activity
relationship to known germ cell mutagens, should be considered for
classification as Category 2 mutagens.
A.5.2.2 Specific considerations for classification of substances
as germ cell mutagens:
A.5.2.2.1 To arrive at a classification, test results are
considered from experiments determining mutagenic and/or genotoxic
effects in germ and/or somatic cells of exposed animals. Mutagenic
and/or genotoxic effects determined in in vitro tests shall also be
considered.
A.5.2.2.2 The system is hazard based, classifying chemicals on
the basis of their intrinsic ability to induce mutations in germ
cells. The scheme is, therefore, not meant for the (quantitative)
risk assessment of chemical substances.
A.5.2.2.3 Classification for heritable effects in human germ
cells is made on the basis of scientifically validated tests.
Evaluation of the test results shall be done using expert judgment
and all the available evidence shall be weighed for classification.
A.5.2.2.4 The classification of substances shall be based on the
total weight of evidence available, using expert judgment. In those
instances where a single well-conducted test is used for
classification, it shall provide clear and unambiguously positive
results. The relevance of the route of exposure used in the study of
the substance compared to the route of human exposure should also be
taken into account.
A.5.3 Classification Criteria for Mixtures 5
---------------------------------------------------------------------------
\5\ It should be noted that the classification criteria for
health hazards usually include a tiered scheme in which test data
available on the complete mixture are considered as the first tier
in the evaluation, followed by the applicable bridging principles,
and lastly, cut-off values/concentration limits or additivity.
However, this approach is not used for Germ Cell Mutagenicity. These
criteria for Germ Cell Mutagenicity consider the cut-off values/
concentration limits as the primary tier and allow the
classification to be modified only on a case-by-case evaluation
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------
A.5.3.1 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.5.3.1.1 Classification of mixtures shall be based on the
available test data for the individual ingredients of the mixture
using cut-off values/concentration limits for the ingredients
classified as germ cell mutagens.
A.5.3.1.2 The mixture will be classified as a mutagen when at
least one ingredient has been classified as a Category 1A, Category
1B or Category 2 mutagen and is present at or above the appropriate
cut-off value/concentration limit as shown in Table A.5.1 below for
Category 1 and 2 respectively.
Table A.5.1--Cut-off Values/Concentration Limits of Ingredients of a
Mixture Classified as Germ Cell Mutagens That Would Trigger
Classification of the Mixture
------------------------------------------------------------------------
Cut-off/concentration limits
triggering classification of a
mixture as:
Ingredient classified as -------------------------------
Category 1 Category 2
mutagen mutagen
------------------------------------------------------------------------
Category 1A/B mutagen................... >=0.1% ..............
Category 2 mutagen...................... .............. >=1.0%
------------------------------------------------------------------------
Note: The cut-off values/concentration limits in the table above apply
to solids and liquids (w/w units) as well as gases (v/v units).
A.5.3.2 Classification of Mixtures When Data Are Available for the
Mixture Itself
The classification may be modified on a case-by-case basis based
on the available test data for the mixture as a whole. In such
cases, the test results for the mixture as a whole must be shown to
be conclusive taking into account dose and other factors such as
duration, observations and analysis (e.g., statistical analysis,
test sensitivity) of germ cell mutagenicity test systems.
A.5.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.5.3.3.1 Where the mixture itself has not been tested to
determine its germ cell mutagenicity hazard, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data will be used in accordance with the following
bridging principles as found in paragraph A.0.5 of this Appendix:
Dilution, Batching, and Substantially similar mixtures.
A.5.4 Examples of Scientifically Validated Test Methods
A.5.4.1 Examples of in vivo heritable germ cell mutagenicity
tests are:
(a) Rodent dominant lethal mutation test (OECD 478)
(b) Mouse heritable translocation assay (OECD 485)
(c) Mouse specific locus test
A.5.4.2 Examples of in vivo somatic cell mutagenicity tests are:
(a) Mammalian bone marrow chromosome aberration test (OECD 475)
(b) Mammalian erythrocyte micronucleus test (OECD 474)
A.5.4.3 Examples of mutagenicity/genotoxicity tests in germ
cells are:
(a) Mutagenicity tests:
(i) Mammalian spermatogonial chromosome aberration test (OECD
483)
(ii) Spermatid micronucleus assay
(b) Genotoxicity tests:
(i) Sister chromatid exchange analysis in spermatogonia
(ii) Unscheduled DNA synthesis test (UDS) in testicular cells
A.5.4.4 Examples of genotoxicity tests in somatic cells are:
(a) Liver Unscheduled DNA Synthesis (UDS) in vivo (OECD 486)
(b) Mammalian bone marrow Sister Chromatid Exchanges (SCE)
A.5.4.5 Examples of in vitro mutagenicity tests are:
(a) In vitro mammalian chromosome aberration test (OECD 473)
(b) In vitro mammalian cell gene mutation test (OECD 476)
(c) Bacterial reverse mutation tests (OECD 471)
A.5.4.6 As new, scientifically validated tests arise, these may
also be used in the total weight of evidence to be considered.
A.6 Carcinogenicity
A.6.1 Definitions
Carcinogenicity refers to the induction of cancer or an increase
in the incidence of cancer occurring after exposure to a substance
or mixture. Substances and mixtures which have induced benign and
malignant tumors in well-performed experimental studies on animals
are considered also to be presumed or suspected human carcinogens
unless there is strong evidence that the mechanism of tumor
formation is not relevant for humans.
Classification of a substance or mixture as posing a
carcinogenic hazard is based on its inherent properties and does not
provide information on the level of the human cancer risk which the
use of the substance or mixture may represent.
A.6.2 Classification Criteria for Substances 6
---------------------------------------------------------------------------
\6\ See Non-mandatory appendix F of this section, part A for
further guidance regarding hazard classification for
carcinogenicity. This appendix is consistent with the GHS and is
provided as guidance excerpted from the International Agency for
Research on Cancer (IARC) ``Monographs on the Evaluation of
Carcinogenic Risks to Humans'' (2006).
---------------------------------------------------------------------------
A.6.2.1 For the purpose of classification for carcinogenicity,
substances are allocated to one of two categories based on strength
of evidence and additional weight of evidence considerations. In
certain instances, route-specific classification may be warranted.
Figure A.6.1--Hazard Categories for Carcinogens
CATEGORY 1: Known or presumed human carcinogens
The placing of a substance in Category 1 is done on the basis of
epidemiological and/or animal data. An individual substance may be
further distinguished:
Category 1A: Known to have carcinogenic potential for humans; the
placing of a substance is largely based on human evidence.
Category 1B: Presumed to have carcinogenic potential for humans; the
placing of a substance is largely based on animal evidence.
Based on strength of evidence together with additional
considerations, such evidence may be derived from human studies that
establish a causal relationship between human exposure to a
substance and the development of cancer (known human carcinogen).
Alternatively, evidence may be derived from animal experiments for
which there is sufficient evidence to demonstrate animal
carcinogenicity (presumed human carcinogen). In addition, on a case
by case basis, scientific judgement may warrant a decision of
presumed human carcinogenicity derived from studies showing limited
evidence of carcinogenicity in humans together with limited evidence
of carcinogenicity in experimental animals.
Classification: Category 1 (A and B) Carcinogen
CATEGORY 2: Suspected human carcinogens
The placing of a substance in Category 2 is done on the basis of
evidence obtained from human and/or animal studies, but which is not
sufficiently convincing to place the substance in Category 1. Based
on strength of evidence together with additional considerations,
such evidence may be from either limited evidence of carcinogenicity
in human studies or from limited evidence of carcinogenicity in
animal studies.
Classification: Category 2 Carcinogen
A.6.2.2 Classification as a carcinogen is made on the basis of
evidence from reliable and acceptable methods, and is intended to be
used for substances which have an intrinsic property to produce such
toxic effects. The evaluations are to be based on all existing data,
peer-reviewed published studies and additional data accepted by
regulatory agencies.
A.6.2.3 Carcinogen classification is a one-step, criterion-based
process that involves two interrelated determinations: evaluations
of strength of evidence and consideration of all other relevant
information to place substances with human cancer potential into
hazard categories.
A.6.2.4 Strength of evidence involves the enumeration of tumors
in human and animal studies and determination of their level of
statistical significance. Sufficient human evidence demonstrates
causality between human exposure and the development of cancer,
whereas sufficient evidence in animals shows a causal relationship
between the agent and an increased incidence of tumors. Limited
evidence in humans is demonstrated by a positive association between
exposure and cancer, but a causal relationship cannot be stated.
Limited evidence in animals is provided when data suggest a
carcinogenic effect, but are less than sufficient. (Guidance on
consideration of important factors in the classification of
carcinogenicity and a more detailed description of the terms
``limited'' and ``sufficient'' have been developed by the
International Agency for Research on Cancer (IARC) and are provided
in non-mandatory appendix F of this section.)
A.6.2.5 Weight of evidence: Beyond the determination of the
strength of evidence for carcinogenicity, a number of other factors
should be considered that influence the overall likelihood that an
agent may pose a carcinogenic hazard in humans. The full list of
factors that influence this determination is very lengthy, but some
of the important ones are considered here.
A.6.2.5.1 These factors can be viewed as either increasing or
decreasing the level of concern for human carcinogenicity. The
relative emphasis accorded to each factor depends upon the amount
and coherence of evidence bearing on each. Generally, there is a
requirement for more complete information to decrease than to
increase the level of concern. Additional considerations should be
used in evaluating the tumor findings and the other factors in a
case-by-case manner.
A.6.2.5.2 Some important factors which may be taken into
consideration, when assessing the overall level of concern are:
(a) Tumor type and background incidence;
(b) Multisite responses;
(c) Progression of lesions to malignancy;
(d) Reduced tumor latency;
Additional factors which may increase or decrease the level of
concern include:
(e) Whether responses are in single or both sexes;
(f) Whether responses are in a single species or several
species;
(g) Structural similarity or not to a substance(s) for which
there is good evidence of carcinogenicity;
(h) Routes of exposure;
(i) Comparison of absorption, distribution, metabolism and
excretion between test animals and humans;
(j) The possibility of a confounding effect of excessive
toxicity at test doses; and,
(k) Mode of action and its relevance for humans, such as
mutagenicity, cytotoxicity with growth stimulation, mitogenesis,
immunosuppression.
Mutagenicity: It is recognized that genetic events are central
in the overall process of cancer development. Therefore, evidence of
mutagenic activity in vivo may indicate that a substance has a
potential for carcinogenic effects.
A.6.2.5.3 A substance that has not been tested for
carcinogenicity may in certain instances be classified in Category
1A, Category 1B, or Category 2 based on tumor data from a structural
analogue together with substantial support from consideration of
other important factors such as formation of common significant
metabolites, e.g., for benzidine congener dyes.
A.6.2.5.4 The classification should also take into consideration
whether or not the substance is absorbed by a given route(s); or
whether there are only local tumors at the site of administration
for the tested route(s), and adequate testing by other major
route(s) show lack of carcinogenicity.
A.6.2.5.5 It is important that whatever is known of the physico-
chemical, toxicokinetic and toxicodynamic properties of the
substances, as well as any available relevant information on
chemical analogues, i.e., structure activity relationship, is taken
into consideration when undertaking classification.
A.6.3 Classification Criteria for Mixtures 7
---------------------------------------------------------------------------
\7\ It should be noted that the classification criteria for
health hazards usually include a tiered scheme in which test data
available on the complete mixture are considered as the first tier i
the evaluation, followed by the applicable bridging principles, and
lastly, cut-off values/concentration limit or addivity. However,
this approach is not used for Carcinogenicity. These criteria for
Carcinogenicity consider the cut-off values/concentration limits as
the primary tier and allow the classification to be modified only on
a case-by-case evaluation based on available test data for the
mixture as a whole.
---------------------------------------------------------------------------
A.6.3.1 The mixture shall be classified as a carcinogen when at
least one ingredient has been classified as a Category 1 or Category
2 carcinogen and is present at or above the appropriate cut-off
value/concentration limit as shown in Table A.6.1.
Table A.6.1--Cut-Off Values/Concentration Limits of Ingredients of a
Mixture Classified as Carcinogen That Would Trigger Classification of
the Mixture
------------------------------------------------------------------------
Category 1 Category 2
Ingredient classified as carcinogen carcinogen
------------------------------------------------------------------------
Category 1 carcinogen................ >=0.1% .................
Category 2 carcinogen................ .............. >=0.1% (note 1)
------------------------------------------------------------------------
Note: If a Category 2 carcinogen ingredient is present in the mixture at
a concentration between 0.1% and 1%, information is required on the
SDS for a product. However, a label warning is optional. If a Category
2 carcinogen ingredient is present in the mixture at a concentration
of =1%, both an SDS and a label is required and the
information must be included on each.
A.6.3.2 Classification of mixtures when data are available for
the complete mixture
A mixture may be classified based on the available test data for
the mixture as a whole. In such cases, the test results for the
mixture as a whole must be shown to be conclusive taking into
account dose and other factors such as duration, observations and
analysis (e.g., statistical analysis, test sensitivity) of
carcinogenicity test systems.
A.6.3.3 Classification of mixtures when data are not available
for the complete mixture: bridging principles
Where the mixture itself has not been tested to determine its
carcinogenic hazard, but there are sufficient data on both the
individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data will be used in
accordance with the following bridging principles as found in
paragraph A.0.5 of this Appendix: Dilution; Batching; and
Substantially similar mixtures.
A.6.4 Classification of Carcinogenicity \8\
---------------------------------------------------------------------------
\8\ See Non-mandatory appendix f of this section for further
guidance regarding hazard classification for carcinogenicity and how
to relate carcinogenicity classification information from IARC and
NTP to GHS.
---------------------------------------------------------------------------
A.6.4.1 Chemical manufacturers, importers and employers
evaluating chemicals may treat the following sources as establishing
that a substance is a carcinogen or potential carcinogen for hazard
communication purposes in lieu of applying the criteria described
herein:
A.6.4.1.1 National Toxicology Program (NTP), ``Report on
Carcinogens'' (latest edition);
A.6.4.1.2 International Agency for Research on Cancer (IARC)
``Monographs on the Evaluation of Carcinogenic Risks to Humans''
(latest editions)
A.6.4.2 Where OSHA has included cancer as a health hazard to be
considered by classifiers for a chemical covered by 29 CFR part
1910, subpart Z, chemical manufacturers, importers, and employers
shall classify the chemical as a carcinogen.
A.7 Reproductive Toxicity
A.7.1 Definitions and General Considerations
A.7.1.1 Reproductive toxicity refers to adverse effects on
sexual function and fertility in adult males and females, as well as
developmental toxicity in the offspring, occurring after exposure to
a substance or mixture. Some reproductive toxic effects cannot be
clearly assigned to either impairment of sexual function and
fertility or to developmental toxicity. Nonetheless, substances and
mixtures with these effects shall be classified as reproductive
toxicants. For classification purposes, the known induction of
genetically based inheritable effects in the offspring is addressed
in Germ cell mutagenicity (See A.5).
A.7.1.2 Adverse effects on sexual function and fertility means
any effect of chemicals that interferes with reproductive ability or
sexual capacity. This includes, but is not limited to, alterations
to the female and male reproductive system, adverse effects on onset
of puberty, gamete production and transport, reproductive cycle
normality, sexual behavior, fertility, parturition, pregnancy
outcomes, premature reproductive senescence, or modifications in
other functions that are dependent on the integrity of the
reproductive systems.
A.7.1.3 Adverse effects on development of the offspring means
any effect of chemicals which interferes with normal development of
the conceptus either before or after birth, which is induced during
pregnancy or results from parental exposure. These effects can be
manifested at any point in the life span of the organism. The major
manifestations of developmental toxicity include death of the
developing organism, structural abnormality, altered growth and
functional deficiency.
A.7.1.4 Adverse effects on or via lactation are also included in
reproductive toxicity, but for classification purposes, such effects
are treated separately (See A.7.2.1).
A.7.2 Classification Criteria for Substances
A.7.2.1 For the purpose of classification for reproductive
toxicity, substances shall be classified in one of two categories in
accordance with Figure A.7.1(a). Effects on sexual function and
fertility, and on development, shall be considered. In addition,
effects on or via lactation shall be classified in a separate hazard
category in accordance with Figure A.7.1(b).
Figure A.7.1(a)--Hazard Categories for Reproductive Toxicants
CATEGORY 1: Known or presumed human reproductive toxicant
This category includes substances which are known to have
produced an adverse effect on sexual function and fertility or on
development in humans or for which there is evidence from animal
studies, possibly supplemented with other information, to provide a
strong presumption that the substance has the capacity to interfere
with reproduction in humans. For regulatory purposes, a substance
can be further distinguished on the basis of whether the evidence
for classification is primarily from human data (Category 1A) or
from animal data (Category 1B).
CATEGORY 1A: Known human reproductive toxicant
The placing of the substance in this category is largely based
on evidence from humans.
CATEGORY 1B: Presumed human reproductive toxicant
The placing of the substance in this category is largely based
on evidence from experimental animals. Data from animal studies
should provide clear evidence of an adverse effect on sexual
function and fertility or on development in the absence of other
toxic effects, or if occurring together with other toxic effects the
adverse effect on reproduction is considered not to be a secondary
non-specific consequence of other toxic effects. However, when there
is mechanistic information that raises doubt about the relevance of
the effect for humans, classification in Category 2 may be more
appropriate.
CATEGORY 2: Suspected human reproductive toxicant
This category includes substances for which there is some
evidence from humans or experimental animals, possibly supplemented
with other information, of an adverse effect on sexual function and
fertility, or on development, in the absence of other toxic effects,
or if occurring together with other toxic effects the adverse effect
on reproduction is considered not to be a secondary non-specific
consequence of the other toxic effects, and where the evidence is
not sufficiently convincing to place the substance in Category 1.
For instance, deficiencies in the study may make the quality of
evidence less convincing, and in view of this Category 2 could be
the more appropriate classification.
Figure A.7.1(b)--Hazard Category for Effects on or Via Lactation
EFFECTS ON OR VIA LACTATION
Effects on or via lactation are allocated to a separate category. It
is appreciated that for many substances there is no information on
the potential to cause adverse effects on the offspring via
lactation. However, substances which are absorbed by women and have
been shown to interfere with lactation, or which may be present
(including metabolites) in breast milk in amounts sufficient to
cause concern for the health of a breastfed child, should be
classified to indicate this property.
Classification for effects via lactation shall be assigned on the
basis of:
(a) absorption, metabolism, distribution and excretion studies
that would indicate the likelihood the substance would be present in
potentially toxic levels in breast milk; and/or
(b) results of one or two generation studies in animals which
provide clear evidence of adverse effect in the offspring due to
transfer in the milk or adverse effect on the quality of the milk;
and/or
(c) human evidence indicating a hazard to babies during the
lactation period.
A.7.2.2 Basis of Classification
A.7.2.2.1 Classification is made on the basis of the criteria,
outlined above, an assessment of the total weight of evidence, and
the use of expert judgment. Classification as a reproductive
toxicant is intended to be used for substances which have an
intrinsic, specific property to produce an adverse effect on
reproduction and substances should not be so classified if such an
effect is produced solely as a non-specific secondary consequence of
other toxic effects.
A.7.2.2.2 In the evaluation of toxic effects on the developing
offspring, it is important to consider the possible influence of
maternal toxicity.
A.7.2.2.3 For human evidence to provide the primary basis for a
Category 1A classification there must be reliable evidence of an
adverse effect on reproduction in humans. Evidence used for
classification shall be from well conducted epidemiological studies,
if available, which include the use of appropriate controls,
balanced assessment, and due consideration of bias or confounding
factors. Less rigorous data from studies in humans may be sufficient
for a Category 1A classification if supplemented with adequate data
from studies in experimental animals, but classification in Category
1B may also be considered.
A.7.2.3 Weight of Evidence
A.7.2.3.1 Classification as a reproductive toxicant is made on
the basis of an assessment of the total weight of evidence using
expert judgment. This means that all available information that
bears on the determination of reproductive toxicity is considered
together. Included is information such as epidemiological studies
and case reports in humans and specific reproduction studies along
with sub-chronic, chronic and special study results in animals that
provide relevant information regarding toxicity to reproductive and
related endocrine organs. Evaluation of substances chemically
related to the material under study may also be included,
particularly when information on the material is scarce. The weight
given to the available evidence will be influenced by factors such
as the quality of the studies, consistency of results, nature and
severity of effects, level of statistical significance for
intergroup differences, number of endpoints affected, relevance of
route of administration to humans and freedom from bias. Both
positive and negative results are considered together in a weight of
evidence determination. However, a single, positive study performed
according to good scientific principles and with statistically or
biologically significant positive results may justify classification
(See also A.7.2.2.3).
A.7.2.3.2 Toxicokinetic studies in animals and humans, site of
action and mechanism or mode of action study results may provide
relevant information, which could reduce or increase concerns about
the hazard to human health. If it is conclusively demonstrated that
the clearly identified mechanism or mode of action has no relevance
for humans or when the toxicokinetic differences are so marked that
it is certain that the hazardous property will not be expressed in
humans then a chemical which produces an adverse effect on
reproduction in experimental animals should not be classified.
A.7.2.3.3 In some reproductive toxicity studies in experimental
animals the only effects recorded may be considered of low or
minimal toxicological significance and classification may not
necessarily be the outcome. These effects include, for example,
small changes in semen parameters or in the incidence of spontaneous
defects in the fetus, small changes in the proportions of common
fetal variants such as are observed in skeletal examinations, or in
fetal weights, or small differences in postnatal developmental
assessments.
A.7.2.3.4 Data from animal studies shall provide sufficient
evidence of specific reproductive toxicity in the absence of other
systemic toxic effects. However, if developmental toxicity occurs
together with other toxic effects in the dam (mother), the potential
influence of the generalized adverse effects should be assessed to
the extent possible. The preferred approach is to consider adverse
effects in the embryo/fetus first, and then evaluate maternal
toxicity, along with any other factors which are likely to have
influenced these effects, as part of the weight of evidence. In
general, developmental effects that are observed at maternally toxic
doses should not be automatically discounted. Discounting
developmental effects that are observed at maternally toxic doses
can only be done on a case-by-case basis when a causal relationship
is established or refuted.
A.7.2.3.5 If appropriate information is available it is
important to try to determine whether developmental toxicity is due
to a specific maternally mediated mechanism or to a non-specific
secondary mechanism, like maternal stress and the disruption of
homeostasis. Generally, the presence of maternal toxicity should not
be used to negate findings of embryo/fetal effects, unless it can be
clearly demonstrated that the effects are secondary non-specific
effects. This is especially the case when the effects in the
offspring are significant, e.g., irreversible effects such as
structural malformations. In some situations it is reasonable to
assume that reproductive toxicity is due to a secondary consequence
of maternal toxicity and discount the effects, for example if the
chemical is so toxic that dams fail to thrive and there is severe
inanition; they are incapable of nursing pups; or they are prostrate
or dying.
A.7.2.4 Maternal Toxicity
A.7.2.4.1 Development of the offspring throughout gestation and
during the early postnatal stages can be influenced by toxic effects
in the mother either through non-specific mechanisms related to
stress and the disruption of maternal homeostasis, or by specific
maternally-mediated mechanisms. So, in the interpretation of the
developmental outcome to decide classification for developmental
effects it is important to consider the possible influence of
maternal toxicity. This is a complex issue because of uncertainties
surrounding the relationship between maternal toxicity and
developmental outcome. Expert judgment and a weight of evidence
approach, using all available studies, shall be used to determine
the degree of influence to be attributed to maternal toxicity when
interpreting the criteria for classification for developmental
effects. The adverse effects in the embryo/fetus shall be first
considered, and then maternal toxicity, along with any other factors
which are likely to have influenced these effects, as weight of
evidence, to help reach a conclusion about classification.
A.7.2.4.2 Based on pragmatic observation, it is believed that
maternal toxicity may, depending on severity, influence development
via non-specific secondary mechanisms, producing effects such as
depressed fetal weight, retarded ossification, and possibly
resorptions and certain malformations in some strains of certain
species. However, the limited numbers of studies which have
investigated the relationship between developmental effects and
general maternal toxicity have failed to demonstrate a consistent,
reproducible relationship across species. Developmental effects
which occur even in the presence of maternal toxicity are considered
to be evidence of developmental toxicity, unless it can be
unequivocally demonstrated on a case by case basis that the
developmental effects are secondary to maternal toxicity. Moreover,
classification shall be considered where there is a significant
toxic effect in the offspring, e.g., irreversible effects such as
structural malformations, embryo/fetal lethality, or significant
post-natal functional deficiencies.
A.7.2.4.3 Classification shall not automatically be discounted
for chemicals that produce developmental toxicity only in
association with maternal toxicity, even if a specific maternally-
mediated mechanism has been demonstrated. In such a case,
classification in Category 2 may be considered more appropriate than
Category 1. However, when a chemical is so toxic that maternal death
or severe inanition results, or the dams (mothers) are prostrate and
incapable of nursing the pups, it is reasonable to assume that
developmental toxicity is produced solely as a secondary consequence
of maternal toxicity and discount the developmental effects.
Classification is not necessarily the outcome in the case of minor
developmental changes, e.g., a small reduction in fetal/pup body
weight or retardation of ossification when seen in association with
maternal toxicity.
A.7.2.4.4 Some of the endpoints used to assess maternal toxicity
are provided below. Data on these endpoints, if available, shall be
evaluated in light of their statistical or biological significance
and dose-response relationship.
(a) Maternal mortality: An increased incidence of mortality
among the treated dams over the controls shall be considered
evidence of maternal toxicity if the increase occurs in a dose-
related manner and can be attributed to the systemic toxicity of the
test material. Maternal mortality greater than 10% is considered
excessive and the data for that dose level shall not normally be
considered to need further evaluation.
(b) Mating index (Number of animals with seminal plugs or sperm/
Number of mated x 100)
(c) Fertility index (Number of animals with implants/Number of
matings x 100)
(d) Gestation length (If allowed to deliver)
(e) Body weight and body weight change: Consideration of the
maternal body weight change and/or adjusted (corrected) maternal
body weight shall be included in the evaluation of maternal toxicity
whenever such data are available. The calculation of an adjusted
(corrected) mean maternal body weight change, which is the
difference between the initial and terminal body weight minus the
gravid uterine weight (or alternatively, the sum of the weights of
the fetuses), may indicate whether the effect is maternal or
intrauterine. In rabbits, the body weight gain may not be a useful
indicator of maternal toxicity because of normal fluctuations in
body weight during pregnancy.
(f) Food and water consumption (if relevant): The observation of
a significant decrease in the average food or water consumption in
treated dams (mothers) compared to the control group may be useful
in evaluating maternal toxicity, particularly when the test material
is administered in the diet or drinking water. Changes in food or
water consumption must be evaluated in conjunction with maternal
body weights when determining if the effects noted are reflective of
maternal toxicity or more simply, unpalatability of the test
material in feed or water.
(g) Clinical evaluations (including clinical signs, markers, and
hematology and clinical chemistry studies): The observation of
increased incidence of significant clinical signs of toxicity in
treated dams (mothers) relative to the control group is useful in
evaluating maternal toxicity. If this is to be used as the basis for
the assessment of maternal toxicity, the types, incidence, degree
and duration of clinical signs shall be reported in the study.
Clinical signs of maternal intoxication include, but are not limited
to: coma, prostration, hyperactivity, loss of righting reflex,
ataxia, or labored breathing.
(h) Post-mortem data: Increased incidence and/or severity of
post-mortem findings may be indicative of maternal toxicity. This
can include gross or microscopic pathological findings or organ
weight data, including absolute organ weight, organ-to-body weight
ratio, or organ-to-brain weight ratio. When supported by findings of
adverse histopathological effects in the affected organ(s), the
observation of a significant change in the average weight of
suspected target organ(s) of treated dams (mothers), compared to
those in the control group, may be considered evidence of maternal
toxicity.
A.7.2.5 Animal and Experimental Data
A.7.2.5.1 A number of scientifically validated test methods are
available, including methods for developmental toxicity testing
(e.g., OECD Test Guideline 414, ICH Guideline S5A, 1993), methods
for peri- and post-natal toxicity testing (e.g., ICH S5B, 1995), and
methods for one or two-generation toxicity testing (e.g., OECD Test
Guidelines 415, 416, 443).
A.7.2.5.2 Results obtained from screening tests (e.g., OECD
Guidelines 421--Reproduction/Developmental Toxicity Screening Test,
and 422--Combined Repeated Dose Toxicity Study with Reproduction/
Development Toxicity Screening Test) can also be used to justify
classification, although the quality of this evidence is less
reliable than that obtained through full studies.
A.7.2.5.3 Adverse effects or changes, seen in short- or long-
term repeated dose toxicity studies, which are judged likely to
impair reproductive function and which occur in the absence of
significant generalized toxicity, may be used as a basis for
classification, e.g., histopathological changes in the gonads.
A.7.2.5.4 Evidence from in vitro assays, or non-mammalian tests,
and from analogous substances using structure-activity relationship
(SAR), can contribute to the procedure for classification. In all
cases of this nature, expert judgment must be used to assess the
adequacy of the data. Inadequate data shall not be used as a primary
support for classification.
A.7.2.5.5 It is preferable that animal studies are conducted
using appropriate routes of administration which relate to the
potential route of human exposure. However, in practice reproductive
toxicity studies are commonly conducted using the oral route, and
such studies will normally be suitable for evaluating the hazardous
properties of the substance with respect to reproductive toxicity.
However, if it can be conclusively demonstrated that the clearly
identified mechanism or mode of action has no relevance for humans
or when the toxicokinetic differences are so marked that it is
certain that the hazardous property will not be expressed in humans
then a substance which produces an adverse effect on reproduction in
experimental animals should not be classified.
A.7.2.5.6 Studies involving routes of administration such as
intravenous or intraperitoneal injection, which may result in
exposure of the reproductive organs to unrealistically high levels
of the test substance, or elicit local damage to the reproductive
organs, e.g., by irritation, must be interpreted with extreme
caution and on their own are not normally the basis for
classification.
A.7.2.5.7 There is general agreement about the concept of a
limit dose, above which the production of an adverse effect may be
considered to be outside the criteria which lead to classification.
Some test guidelines specify a limit dose, other test guidelines
qualify the limit dose with a statement that higher doses may be
necessary if anticipated human exposure is sufficiently high that an
adequate margin of exposure would not be achieved. Also, due to
species differences in toxicokinetics, establishing a specific limit
dose may not be adequate for situations where humans are more
sensitive than the animal model.
A.7.2.5.8 In principle, adverse effects on reproduction seen
only at very high dose levels in animal studies (for example doses
that induce prostration, severe inappetence, excessive mortality) do
not normally lead to classification, unless other information is
available, for example, toxicokinetics information indicating that
humans may be more susceptible than animals, to suggest that
classification is appropriate.
A.7.2.5.9 However, specification of the actual ``limit dose''
will depend upon the test method that has been employed to provide
the test results.
A.7.3 Classification Criteria for Mixtures 9
---------------------------------------------------------------------------
\9\ It should be noted that the classification criteria for
health hazards usually include a tiered scheme in which test data
available on the complete mixture are considered as the first tier
in the evaluation, followed by the applicable bridging principles,
and lastly, cut-off values/concentration limits or additivity.
However, this approach is not used for Reproductive Toxicity. These
criteria for Reproductive Toxicity consider the cut-off values/
concentration limits as the primary tier and allow the
classification to be modified only on a case-by-case evaluation
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------
A.7.3.1 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.7.3.1.1 The mixture shall be classified as a reproductive
toxicant when at least one ingredient has been classified as a
Category 1 or Category 2 reproductive toxicant and is present at or
above the appropriate cut-off value/concentration limit specified in
Table A.7.1 for Category 1 and 2, respectively.
A.7.3.1.2 The mixture shall be classified for effects on or via
lactation when at least one ingredient has been classified for
effects on or via lactation and is present at or above the
appropriate cut-off value/concentration limit specified in Table
A.7.1 for the additional category for effects on or via lactation.
Table A.7.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Reproductive
Toxicants or for Effects on or Via Lactation That Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
Cut-off values/concentration limits triggering
classification of a mixture as
-----------------------------------------------
Ingredient classified as Additional
Category 1 Category 2 category for
reproductive reproductive effects on or
toxicant toxicant via lactation
----------------------------------------------------------------------------------------------------------------
Category 1 reproductive toxicant................................ >=0.01% .............. ..............
Category 2 reproductive toxicant................................ .............. >=0.01% ..............
Additional category for effects on or via lactation............. .............. .............. >=0.01%
----------------------------------------------------------------------------------------------------------------
A.7.3.2 Classification of Mixtures When Data Are Available for the
Complete Mixture
Available test data for the mixture as a whole may be used for
classification on a case-by-case basis. In such cases, the test
results for the mixture as a whole must be shown to be conclusive
taking into account dose and other factors such as duration,
observations and analysis (e.g., statistical analysis, test
sensitivity) of reproduction test systems.
A.7.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.7.3.1.1 Where the mixture itself has not been tested to
determine its reproductive toxicity, but there are sufficient data
on both the individual ingredients and similar tested mixtures to
adequately characterize the hazards of the mixture, these data shall
be used in accordance with the following bridging principles as
found in paragraph A.0.5 of this Appendix: Dilution, Batching, and
Substantially similar mixtures.
A.8 Specific Target Organ Toxicity Single Exposure
A.8.1 Definitions and General Considerations
A.8.1.1 Specific target organ toxicity--single exposure, (STOT-
SE) refers to specific, non-lethal toxic effects on target organs
occurring after a single exposure to a substance or mixture. All
significant health effects that can impair function, both reversible
and irreversible, immediate and/or delayed and not specifically
addressed in A.1 to A.7 and A.10 of this Appendix are included.
Specific target organ toxicity following repeated exposure is
classified in accordance with SPECIFIC TARGET ORGAN TOXICITY--
REPEATED EXPOSURE (A.9 of this Appendix) and is therefore not
included here.
A.8.1.2 Classification identifies the chemical as being a
specific target organ toxicant and, as such, it presents a potential
for adverse health effects in people who are exposed to it.
A.8.1.3 The adverse health effects produced by a single exposure
include consistent and identifiable toxic effects in humans; or, in
experimental animals, toxicologically significant changes which have
affected the function or morphology of a tissue/organ, or have
produced serious changes to the biochemistry or hematology of the
organism, and these changes are relevant for human health. Human
data is the primary source of evidence for this hazard class.
A.8.1.4 Assessment shall take into consideration not only
significant changes in a single organ or biological system but also
generalized changes of a less severe nature involving several
organs.
A.8.1.5 Specific target organ toxicity can occur by any route
that is relevant for humans, i.e., principally oral, dermal or
inhalation.
A.8.1.6 The classification criteria for specific target organ
toxicity--single exposure are organized as criteria for substances
Categories 1 and 2 (See A.8.2.1), criteria for substances Category 3
(See A.8.2.2) and criteria for mixtures (See A.8.3). See also Figure
A.8.1.
A.8.2 Classification Criteria for Substances
A.8.2.1 Substances of Category 1 and Category 2
A.8.2.1.1 Substances shall be classified for immediate or
delayed effects separately, by the use of expert judgment on the
basis of the weight of all evidence available, including the use of
recommended guidance values (See A.8.2.1.9). Substances shall then
be classified in Category 1 or 2, depending upon the nature and
severity of the effect(s) observed, in accordance with Figure A.8.1.
Figure A.8.1--Hazard Categories for Specific Target Organ Toxicity
Following Single Exposure
CATEGORY 1: Substances that have produced significant toxicity in
humans, or that, on the basis of evidence from studies in
experimental animals can be presumed to have the potential to
produce significant toxicity in humans following single exposure
Placing a substance in Category 1 is done on the basis of:
(a) reliable and good quality evidence from human cases or
epidemiological studies; or
(b) observations from appropriate studies in experimental
animals in which significant and/or severe toxic effects of
relevance to human health were produced at generally low exposure
concentrations. Guidance dose/concentration values are provided
below (see 3.8.2.1.9) to be used as part of weight-of-evidence
evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies
in experimental animals can be presumed to have the potential to be
harmful to human health following single exposure
Placing a substance in Category 2 is done on the basis of
observations from appropriate studies in experimental animals in
which significant toxic effects, of relevance to human health, were
produced at generally moderate exposure concentrations. Guidance
dose/concentration values are provided below (see 3.8.2.1.9) in
order to help in classification.
In exceptional cases, human evidence can also be used to place a
substance in Category 2 (see 3.8.2.1.9).
CATEGORY 3: Transient target organ effects
There are target organ effects for which a substance/mixture may
not meet the criteria to be classified in Categories 1 or 2
indicated above. These are effects which adversely alter human
function for a short duration after exposure and from which humans
may recover in a reasonable period without leaving significant
alteration of structure or function. This category only includes
narcotic effects and respiratory tract irritation. Substances/
mixtures may be classified specifically for these effects as
discussed in 3.8.2.2.
Note: For these categories the specific target organ/system that
has been primarily affected by the classified substance may be
identified, or the substance may be identified as a general
toxicant. Attempts should be made to determine the primary target
organ/system of toxicity and classify for that purpose, e.g.,
hepatotoxicants, neurotoxicants. One should carefully evaluate the
data and, where possible, not include secondary effects, e.g., a
hepatotoxicant can produce secondary effects in the nervous or
gastro-intestinal systems.
A.8.2.1.2 The relevant route(s) of exposure by which the
classified substance produces damage shall be identified.
A.8.2.1.3 Classification is determined by expert judgment, on
the basis of the weight of all evidence available including the
guidance presented below.
A.8.2.1.4 Weight of evidence of all available data, including
human incidents, epidemiology, and studies conducted in experimental
animals is used to substantiate specific target organ toxic effects
that merit classification.
A.8.2.1.5 The information required to evaluate specific target
organ toxicity comes either from single exposure in humans (e.g.,
exposure at home, in the workplace or
environmentally), or from studies conducted in experimental animals.
The standard animal studies in rats or mice that provide this
information are acute toxicity studies which can include clinical
observations and detailed macroscopic and microscopic examination to
enable the toxic effects on target tissues/organs to be identified.
Results of acute toxicity studies conducted in other species may
also provide relevant information.
A.8.2.1.6 In exceptional cases, based on expert judgment, it may
be appropriate to place certain substances with human evidence of
target organ toxicity in Category 2: (a) when the weight of human
evidence is not sufficiently convincing to warrant Category 1
classification, and/or (b) based on the nature and severity of
effects. Dose/concentration levels in humans shall not be considered
in the classification and any available evidence from animal studies
shall be consistent with the Category 2 classification. In other
words, if there are also animal data available on the substance that
warrant Category 1 classification, the chemical shall be classified
as Category 1.
A.8.2.1.7 Effects Considered To Support Classification for Category 1
and 2
A.8.2.1.7.1 Classification is supported by evidence associating
single exposure to the substance with a consistent and identifiable
toxic effect.
A.8.2.1.7.2 Evidence from human experience/incidents is usually
restricted to reports of adverse health consequences, often with
uncertainty about exposure conditions, and may not provide the
scientific detail that can be obtained from well-conducted studies
in experimental animals.
A.8.2.1.7.3 Evidence from appropriate studies in experimental
animals can furnish much more detail, in the form of clinical
observations, and macroscopic and microscopic pathological
examination and this can often reveal hazards that may not be life-
threatening but could indicate functional impairment. Consequently,
all available evidence, and relevance to human health, must be taken
into consideration in the classification process. Relevant toxic
effects in humans and/or animals include, but are not limited to:
(a) Morbidity resulting from single exposure;
(b) Significant functional changes, more than transient in
nature, in the respiratory system, central or peripheral nervous
systems, other organs or other organ systems, including signs of
central nervous system depression and effects on special senses
(e.g., sight, hearing and sense of smell);
(c) Any consistent and significant adverse change in clinical
biochemistry, hematology, or urinalysis parameters;
(d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis or granuloma
formation in vital organs with regenerative capacity;
(f) Morphological changes that are potentially reversible but
provide clear evidence of marked organ dysfunction; and,
(g) Evidence of appreciable cell death (including cell
degeneration and reduced cell number) in vital organs incapable of
regeneration.
A.8.2.1.8 Effects Considered Not To Support Classification for Category
1 and 2
Effects may be seen in humans and/or animals that do not justify
classification. Such effects include, but are not limited to:
(a) Clinical observations or small changes in bodyweight gain,
food consumption or water intake that may have some toxicological
importance but that do not, by themselves, indicate ``significant''
toxicity;
(b) Small changes in clinical biochemistry, hematology or
urinalysis parameters and/or transient effects, when such changes or
effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ
dysfunction;
(d) Adaptive responses that are not considered toxicologically
relevant; and,
(e) Substance-induced species-specific mechanisms of toxicity,
i.e., demonstrated with reasonable certainty to be not relevant for
human health, shall not justify classification.
A.8.2.1.9 Guidance Values To Assist With Classification Based on the
Results Obtained From Studies Conducted in Experimental Animals for
Category 1 and 2
A.8.2.1.9.1 In order to help reach a decision about whether a
substance shall be classified or not, and to what degree it shall be
classified (Category 1 vs. Category 2), dose/concentration
``guidance values'' are provided for consideration of the dose/
concentration which has been shown to produce significant health
effects. The principal argument for proposing such guidance values
is that all chemicals are potentially toxic and there has to be a
reasonable dose/concentration above which a degree of toxic effect
is acknowledged.
A.8.2.1.9.2 Thus, in animal studies, when significant toxic
effects are observed that indicate classification, consideration of
the dose/concentration at which these effects were seen, in relation
to the suggested guidance values, provides useful information to
help assess the need to classify (since the toxic effects are a
consequence of the hazardous property(ies) and also the dose/
concentration).
A.8.2.1.9.3 The guidance value (C) ranges for single-dose
exposure which has produced a significant non-lethal toxic effect
are those applicable to acute toxicity testing, as indicated in
Table A.8.1.
Table A.8.1--Guidance Value Ranges for Single-Dose Exposures
----------------------------------------------------------------------------------------------------------------
Guidance value ranges for:
Route of exposure Units -----------------------------------------------------------
Category 1 Category 2 Category 3
----------------------------------------------------------------------------------------------------------------
Oral (rat)...................... mg/kg body weight. C <= 300.......... 2,000 >= C > 300.. Guidance values do
not apply.
Dermal (rat or rabbit).......... mg/kg body weight. C <= 1,000........ 2,000 >= C > 1,000
Inhalation (rat) gas............ ppmV/4h........... C <= 2,500........ 20,000 >= C >
2,500.
Inhalation (rat) vapor.......... mg/1/4h........... C <= 10........... 20 >= C > 10......
Inhalation (rat) dust/mist/fume. mg/l/4h........... C <= 1.0.......... 5.0 >= C > 1.0....
----------------------------------------------------------------------------------------------------------------
A.8.2.1.9.4 The guidance values and ranges mentioned in Table
A.8.1 are intended only for guidance purposes, i.e., to be used as
part of the weight of evidence approach, and to assist with
decisions about classification. They are not intended as strict
demarcation values. Guidance values are not provided for Category 3
since this classification is primarily based on human data; animal
data may be included in the weight of evidence evaluation.
A.8.2.1.9.5 Thus, it is feasible that a specific profile of
toxicity occurs at a dose/concentration below the guidance value,
e.g., <2,000 mg/kg body weight by the oral route, however the nature
of the effect may result in the decision not to classify.
Conversely, a specific profile of toxicity may be seen in animal
studies occurring at above a guidance value, e.g., >=2,000 mg/kg
body weight by the oral route, and in addition there is
supplementary information from other sources, e.g., other single
dose studies, or human case experience, which supports a conclusion
that, in view of the weight of evidence, classification is the
prudent action to take.
A.8.2.1.10 Other Considerations
A.8.2.1.10.1 When a substance is characterized only by use of
animal data the classification process includes reference to dose/
concentration guidance values as one of the elements that contribute
to the weight of evidence approach.
A.8.2.1.10.2 When well-substantiated human data are available
showing a specific target organ toxic effect that can be reliably
attributed to single exposure to a substance, the substance shall be
classified. Positive human data, regardless of probable dose,
predominates over animal data. Thus, if a substance is unclassified
because specific target organ toxicity observed was considered not
relevant or significant to humans, if subsequent human incident data
become available showing a specific target organ toxic effect, the
substance shall be classified.
A.8.2.1.10.3 A substance that has not been tested for specific
target organ toxicity shall, where appropriate, be classified on the
basis of data from a scientifically validated structure activity
relationship and expert judgment-based extrapolation from a
structural analogue that has previously been classified together
with substantial support from consideration of other important
factors such as formation of common significant metabolites.
A.8.2.2 Substances of Category 3
A.8.2.2.1 Criteria for respiratory tract irritation
The criteria for classifying substances as Category 3 for
respiratory tract irritation are:
(a) Respiratory irritant effects (characterized by localized
redness, edema, pruritis and/or pain) that impair function with
symptoms such as cough, pain, choking, and breathing difficulties
are included. It is recognized that this evaluation is based
primarily on human data;
(b) Subjective human observations supported by objective
measurements of clear respiratory tract irritation (RTI) (e.g.,
electrophysiological responses, biomarkers of inflammation in nasal
or bronchoalveolar lavage fluids);
(c) The symptoms observed in humans shall also be typical of
those that would be produced in the exposed population rather than
being an isolated idiosyncratic reaction or response triggered only
in individuals with hypersensitive airways. Ambiguous reports simply
of ``irritation'' should be excluded as this term is commonly used
to describe a wide range of sensations including those such as
smell, unpleasant taste, a tickling sensation, and dryness, which
are outside the scope of classification for respiratory tract
irritation;
(d) There are currently no scientifically validated animal tests
that deal specifically with RTI; however, useful information may be
obtained from the single and repeated inhalation toxicity tests. For
example, animal studies may provide useful information in terms of
clinical signs of toxicity (dyspnoea, rhinitis etc.) and
histopathology (e.g., hyperemia, edema, minimal inflammation,
thickened mucous layer) which are reversible and may be reflective
of the characteristic clinical symptoms described above. Such animal
studies can be used as part of weight of evidence evaluation; and,
(e) This special classification will occur only when more severe
organ effects including the respiratory system are not observed as
those effects would require a higher classification.
A.8.2.2.2 Criteria for Narcotic Effects
The criteria for classifying substances in Category 3 for
narcotic effects are:
(a) Central nervous system depression including narcotic effects
in humans such as drowsiness, narcosis, reduced alertness, loss of
reflexes, lack of coordination, and vertigo are included. These
effects can also be manifested as severe headache or nausea, and can
lead to reduced judgment, dizziness, irritability, fatigue, impaired
memory function, deficits in perception and coordination, reaction
time, or sleepiness; and,
(b) Narcotic effects observed in animal studies may include
lethargy, lack of coordination righting reflex, narcosis, and
ataxia. If these effects are not transient in nature, then they
shall be considered for classification as Category 1 or 2.
A.8.3 Classification Criteria for Mixtures
A.8.3.1 Mixtures are classified using the same criteria as for
substances, or alternatively as described below. As with substances,
mixtures may be classified for specific target organ toxicity
following single exposure, repeated exposure, or both.
A.8.3.2 Classification of Mixtures When Data Are Available for the
Complete Mixture
When reliable and good quality evidence from human experience or
appropriate studies in experimental animals, as described in the
criteria for substances, is available for the mixture, then the
mixture shall be classified by weight of evidence evaluation of this
data. Care shall be exercised in evaluating data on mixtures, that
the dose, duration, observation or analysis, do not render the
results inconclusive.
A.8.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.8.3.3.1 Where the mixture itself has not been tested to
determine its specific target organ toxicity, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data shall be used in accordance with the following
bridging principles as found in paragraph A.0.5 of this Appendix:
Dilution, Batching, Concentration of mixtures, Interpolation within
one hazard category, Substantially similar mixtures, or Aerosols.
A.8.3.4 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.8.3.4.1 Where there is no reliable evidence or test data for
the specific mixture itself, and the bridging principles cannot be
used to enable classification, then classification of the mixture is
based on the classification of the ingredient substances. In this
case, the mixture shall be classified as a specific target organ
toxicant (specific organ specified), following single exposure,
repeated exposure, or both when at least one ingredient has been
classified as a Category 1 or Category 2 specific target organ
toxicant and is present at or above the appropriate cut-off value/
concentration limit specified in Table A.8.2 for Categories 1 and 2,
respectively.
Table A.8.2--Cut-Off Values/Concentration Limits of Ingredients of a
Mixture Classified as a Specific Target Organ Toxicant That Would
Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
Cut-off values/concentration limits
triggering classification of a
Ingredient classified as mixture as
-------------------------------------
Category 1 Category 2
------------------------------------------------------------------------
Category 1 Target organ toxicant.. >=1.0% .................
Category 2 Target organ toxicant.. ................. >=1.0%
------------------------------------------------------------------------
A.8.3.4.2 These cut-off values and consequent classifications
shall be applied equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.8.3.4.3 Mixtures shall be classified for either or both single
and repeated dose toxicity independently.
A.8.3.4.4 Care shall be exercised when toxicants affecting more
than one organ system are combined that the potentiation or
synergistic interactions are considered, because certain substances
can cause target organ toxicity at <1% concentration when other
ingredients in the mixture are known to potentiate its toxic effect.
A.8.3.4.5 Care shall be exercised when extrapolating the
toxicity of a mixture that contains Category 3 ingredient(s). A cut-
off value/concentration limit of 20%, considered as an additive of
all Category 3 ingredients for each hazard endpoint, is appropriate;
however, this cut-off value/concentration limit may be higher or
lower depending on the Category 3 ingredient(s) involved and the
fact that some effects such as respiratory tract irritation may not
occur below a certain concentration while other effects such as
narcotic effects may occur below this 20% value. Expert judgment
shall be exercised. Respiratory tract irritation and narcotic
effects are to be evaluated separately in accordance with the
criteria given in A.8.2.2. When conducting classifications for these
hazards, the contribution of each ingredient should be considered
additive, unless there is evidence that the effects are not
additive.
A.8.3.4.6 In cases where the additivity approach is used for
Category 3 ingredients, the ``relevant ingredients'' of a mixture
are those which are present in concentrations >=1% (w/w for solids,
liquids, dusts, mists,
and vapours and v/v for gases), unless there is a reason to suspect
that an ingredient present at a concentration <1% is still relevant
when classifying the mixture for respiratory tract irritation or
narcotic effects.
A.9 Specific Target Organ Toxicity--Repeated or Prolonged Exposure
A.9.1 Definitions and General Considerations
A.9.1.1 Specific target organ toxicity--repeated exposure (STOT-
RE) refers to specific toxic effects on target organs occurring
after repeated exposure to a substance or mixture. All significant
health effects that can impair function, both reversible and
irreversible, immediate and/or delayed and not specifically
addressed in A.1 to A.7 and A.10 of this Appendix are included.
Specific target organ toxicity following a single-event exposure is
classified in accordance with SPECIFIC TARGET ORGAN TOXICITY--SINGLE
EXPOSURE (A.8 of this Appendix) and is therefore not included here.
A.9.1.2 Classification identifies the substance or mixture as
being a specific target organ toxicant and, as such, it may present
a potential for adverse health effects in people who are exposed to
it.
A.9.1.3 These adverse health effects produced by repeated
exposure include consistent and identifiable toxic effects in
humans, or, in experimental animals, toxicologically significant
changes which have affected the function or morphology of a tissue/
organ, or have produced serious changes to the biochemistry or
hematology of the organism and these changes are relevant for human
health. Human data will be the primary source of evidence for this
hazard class.
A.9.1.4 Assessment shall take into consideration not only
significant changes in a single organ or biological system but also
generalized changes of a less severe nature involving several
organs.
A.9.1.5 Specific target organ toxicity can occur by any route
that is relevant for humans, e.g., principally oral, dermal or
inhalation.
A.9.2 Classification Criteria for Substances
A.9.2.1 Substances shall be classified as STOT--RE by expert
judgment on the basis of the weight of all evidence available,
including the use of recommended guidance values which take into
account the duration of exposure and the dose/concentration which
produced the effect(s), (See A.9.2.9). Substances shall be placed in
one of two categories, depending upon the nature and severity of the
effect(s) observed, in accordance with Figure A.9.1.
Figure A.9.1--Hazard Categories for Specific Target Organ Toxicity
Following Repeated Exposure
CATEGORY 1: Substances that have produced significant toxicity in
humans, or that, on the basis of evidence from studies in
experimental animals can be presumed to have the potential to
produce significant toxicity in humans following repeated or
prolonged exposure
Substances are classified in Category 1 for specific target organ
toxicity (repeated exposure) on the basis of:
(a) reliable and good quality evidence from human cases or
epidemiological studies; or,
(b) observations from appropriate studies in experimental
animals in which significant and/or severe toxic effects, of
relevance to human health, were produced at generally low exposure
concentrations. Guidance dose/concentration values are provided
below (See A.9.2.9) to be used as part of weight-of-evidence
evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies
in experimental animals can be presumed to have the potential to be
harmful to human health following repeated or prolonged exposure
Substances are classified in Category 2 for specific target organ
toxicity (repeated exposure) on the basis of observations from
appropriate studies in experimental animals in which significant
toxic effects, of relevance to human health, were produced at
generally moderate exposure concentrations. Guidance dose/
concentration values are provided below (See A.9.2.9) in order to
help in classification.
In exceptional cases human evidence can also be used to place a
substance in Category 2 (See A.9.2.6).
Note: The primary target organ/system shall be identified where
possible, or the substance shall be identified as a general
toxicant. The data shall be carefully evaluated and, where possible,
shall not include secondary effects (e.g., a hepatotoxicant can
produce secondary effects in the nervous or gastro-intestinal
systems).
A.9.2.2 The relevant route of exposure by which the classified
substance produces damage shall be identified.
A.9.2.3 Classification is determined by expert judgment, on the
basis of the weight of all evidence available including the guidance
presented below.
A.9.2.4 Weight of evidence of all data, including human
incidents, epidemiology, and studies conducted in experimental
animals, is used to substantiate specific target organ toxic effects
that merit classification.
A.9.2.5 The information required to evaluate specific target
organ toxicity comes either from repeated exposure in humans, e.g.,
exposure at home, in the workplace or environmentally, or from
studies conducted in experimental animals. The standard animal
studies in rats or mice that provide this information are 28 day, 90
day or lifetime studies (up to 2 years) that include hematological,
clinico-chemical and detailed macroscopic and microscopic
examination to enable the toxic effects on target tissues/organs to
be identified. Data from repeat dose studies performed in other
species may also be used. Other long-term exposure studies, e.g.,
for carcinogenicity, neurotoxicity or reproductive toxicity, may
also provide evidence of specific target organ toxicity that could
be used in the assessment of classification.
A.9.2.6 In exceptional cases, based on expert judgment, it may
be appropriate to place certain substances with human evidence of
specific target organ toxicity in Category 2: (a) when the weight of
human evidence is not sufficiently convincing to warrant Category 1
classification, and/or (b) based on the nature and severity of
effects. Dose/concentration levels in humans shall not be considered
in the classification and any available evidence from animal studies
shall be consistent with the Category 2 classification. In other
words, if there are also animal data available on the substance that
warrant Category 1 classification, the substance shall be classified
as Category 1.
A.9.2.7 Effects Considered To Support Classification
A.9.2.7.1 Classification is supported by reliable evidence
associating repeated exposure to the substance with a consistent and
identifiable toxic effect.
A.9.2.7.2 Evidence from human experience/incidents is usually
restricted to reports of adverse health consequences, often with
uncertainty about exposure conditions, and may not provide the
scientific detail that can be obtained from well-conducted studies
in experimental animals.
A.9.2.7.3 Evidence from appropriate studies in experimental
animals can furnish much more detail, in the form of clinical
observations, hematology, clinical chemistry, macroscopic and
microscopic pathological examination and this can often reveal
hazards that may not be life-threatening but could indicate
functional impairment. Consequently, all available evidence, and
relevance to human health, must be taken into consideration in the
classification process. Relevant toxic effects in humans and/or
animals include, but are not limited to:
(a) Morbidity or death resulting from repeated or long-term
exposure. Morbidity or death may result from repeated exposure, even
to relatively low doses/concentrations, due to bioaccumulation of
the substance or its metabolites, or due to the overwhelming of the
de-toxification process by repeated exposure;
(b) Significant functional changes in the central or peripheral
nervous systems or other organ systems, including signs of central
nervous system depression and effects on special senses (e.g.,
sight, hearing and sense of smell);
(c) Any consistent and significant adverse change in clinical
biochemistry, hematology, or urinalysis parameters;
(d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis or granuloma
formation in vital organs with regenerative capacity;
(f) Morphological changes that are potentially reversible but
provide clear evidence of marked organ dysfunction (e.g., severe
fatty change in the liver); and,
(g) Evidence of appreciable cell death (including cell
degeneration and reduced cell number) in vital organs incapable of
regeneration.
A.9.2.8 Effects Considered Not To Support Classification
Effects may be seen in humans and/or animals that do not justify
classification. Such effects include, but are not limited to:
(a) Clinical observations or small changes in bodyweight gain,
food consumption or water intake that may have some toxicological
importance but that do not, by themselves, indicate ``significant''
toxicity;
(b) Small changes in clinical biochemistry, hematology or
urinalysis parameters and/or transient effects, when such changes or
effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ
dysfunction;
(d) Adaptive responses that are not considered toxicologically
relevant;
(e) Substance-induced species-specific mechanisms of toxicity,
i.e., demonstrated with reasonable certainty to be not relevant for
human health, shall not justify classification.
A.9.2.9 Guidance Values To Assist With Classification Based on the
Results Obtained From Studies Conducted in Experimental Animals
A.9.2.9.1 In studies conducted in experimental animals, reliance
on observation of effects alone, without reference to the duration
of experimental exposure and dose/concentration, omits a fundamental
concept of toxicology, i.e., all substances are potentially toxic,
and what determines the toxicity is a function of the dose/
concentration and the duration of exposure. In most studies
conducted in experimental animals the test guidelines use an upper
limit dose value.
A.9.2.9.2 In order to help reach a decision about whether a
substance shall be classified or not, and to what degree it shall be
classified (Category 1 vs. Category 2), dose/concentration
``guidance values'' are provided in Table A.9.1 for consideration of
the dose/concentration which has been shown to produce significant
health effects. The principal argument for proposing such guidance
values is that all chemicals are potentially toxic and there has to
be a reasonable dose/concentration above which a degree of toxic
effect is acknowledged. Also, repeated-dose studies conducted in
experimental animals are designed to produce toxicity at the highest
dose used in order to optimize the test objective and so most
studies will reveal some toxic effect at least at this highest dose.
What is therefore to be decided is not only what effects have been
produced, but also at what dose/concentration they were produced and
how relevant is that for humans.
A.9.2.9.3 Thus, in animal studies, when significant toxic
effects are observed that indicate classification, consideration of
the duration of experimental exposure and the dose/concentration at
which these effects were seen, in relation to the suggested guidance
values, provides useful information to help assess the need to
classify (since the toxic effects are a consequence of the hazardous
property(ies) and also the duration of exposure and the dose/
concentration).
A.9.2.9.4 The decision to classify at all can be influenced by
reference to the dose/concentration guidance values at or below
which a significant toxic effect has been observed.
A.9.2.9.5 The guidance values refer to effects seen in a
standard 90-day toxicity study conducted in rats. They can be used
as a basis to extrapolate equivalent guidance values for toxicity
studies of greater or lesser duration, using dose/exposure time
extrapolation similar to Haber's rule for inhalation, which states
essentially that the effective dose is directly proportional to the
exposure concentration and the duration of exposure. The assessment
should be done on a case- by-case basis; for example, for a 28-day
study the guidance values below would be increased by a factor of
three.
A.9.2.9.6 Thus for Category 1 classification, significant toxic
effects observed in a 90-day repeated-dose study conducted in
experimental animals and seen to occur at or below the (suggested)
guidance values (C) as indicated in Table A.9.1 would justify
classification:
Table A.9.1--Guidance Values To Assist in Category 1 Classification
[Applicable to a 90-day study]
----------------------------------------------------------------------------------------------------------------
Route of exposure Units Guidance values (dose/concentration)
----------------------------------------------------------------------------------------------------------------
Oral (rat).............................. mg/kg body weight/day...... C <= 10
Dermal (rat or rabbit).................. mg/kg body weight/day...... C <= 20
Inhalation (rat) gas.................... ppmV/6h/day................ C <= 50
Inhalation (rat) vapor.................. mg/liter/6h/day............ C <= 0.2
Inhalation (rat) dust/mist/fume......... mg/liter/6h/day............ C <= 0.02
----------------------------------------------------------------------------------------------------------------
A.9.2.9.7 For Category 2 classification, significant toxic
effects observed in a 90-day repeated-dose study conducted in
experimental animals and seen to occur within the (suggested)
guidance value ranges as indicated in Table A.9.2 would justify
classification:
Table A.9.2--Guidance Values To Assist in Category 2 Classification
[Applicable to a 90-day study]
----------------------------------------------------------------------------------------------------------------
Route of exposure Units Guidance value range (dose/concentration)
----------------------------------------------------------------------------------------------------------------
Oral (rat).............................. mg/kg body weight/day...... 10 < C <= 100
Dermal (rat or rabbit).................. mg/kg body weight/day...... 20 < C <= 200
Inhalation (rat) gas.................... ppmV/6h/day................ 50 < C <= 250
Inhalation (rat) vapor.................. mg/liter/6h/day............ 0.2 < C <= 1.0
Inhalation (rat) dust/mist/fume......... mg/liter/6h/day............ 0.02 < C <= 0.2
----------------------------------------------------------------------------------------------------------------
A.9.2.9.8 The guidance values and ranges mentioned in A.2.9.9.6
and A.2.9.9.7 are intended only for guidance purposes, i.e., to be
used as part of the weight of evidence approach, and to assist with
decisions about classification. They are not intended as strict
demarcation values.
A.9.2.9.9 Thus, it is possible that a specific profile of
toxicity occurs in repeat-dose animal studies at a dose/
concentration below the guidance value, e.g., <100 mg/kg body
weight/day by the oral route, however the nature of the effect,
e.g., nephrotoxicity seen only in male rats of a particular strain
known to be susceptible to this effect, may result in the decision
not to classify. Conversely, a specific profile of toxicity may be
seen in animal studies occurring at above a guidance value, e.g.,
>=100 mg/kg body weight/day by the oral route, and in addition there
is supplementary information from other sources, e.g., other long-
term administration studies, or human case experience, which
supports a conclusion that, in view of the weight of evidence,
classification is prudent.
A.9.2.10 Other Considerations
A.9.2.10.1 When a substance is characterized only by use of
animal data the classification process includes reference to dose/
concentration guidance values as one of the elements that contribute
to the weight of evidence approach.
A.9.2.10.2 When well-substantiated human data are available
showing a specific target organ toxic effect that can be reliably
attributed to repeated or prolonged exposure to a substance, the
substance shall be classified. Positive human data, regardless of
probable dose, predominates over animal data. Thus, if a substance
is unclassified because no specific target organ toxicity was seen
at or below the dose/concentration guidance value for animal
testing, if subsequent human incident data become available showing
a specific target organ toxic effect, the substance shall be
classified.
A.9.2.10.3 A substance that has not been tested for specific
target organ toxicity may in certain instances, where appropriate,
be classified on the basis of data from a scientifically validated
structure activity relationship and expert judgment-based
extrapolation from a structural analogue that has previously been
classified together with substantial support from consideration of
other important factors such as formation of common significant
metabolites.
A.9.3 Classification Criteria for Mixtures
A.9.3.1 Mixtures are classified using the same criteria as for
substances, or alternatively as described below. As with substances,
mixtures may be classified for specific target organ toxicity
following single exposure, repeated exposure, or both.
A.9.3.2 Classification of Mixtures When Data Are Available for the
Complete Mixture
When reliable and good quality evidence from human experience or
appropriate studies in experimental animals, as described in the
criteria for substances, is available for the mixture, then the
mixture shall be classified by weight of evidence evaluation of
these data. Care shall be exercised in evaluating data on mixtures,
that the dose, duration, observation or analysis, do not render the
results inconclusive.
A.9.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.9.3.3.1 Where the mixture itself has not been tested to
determine its specific target organ toxicity, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data shall be used in accordance with the following
bridging principles as found in paragraph A.0.5 of this Appendix:
Dilution; Batching; Concentration of mixtures; Interpolation within
one hazard category; Substantially similar mixtures; and Aerosols.
A.9.3.4 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.9.3.4.1 Where there is no reliable evidence or test data for
the specific mixture itself, and the bridging principles cannot be
used to enable classification, then classification of the mixture is
based on the classification of the ingredient substances. In this
case, the mixture shall be classified as a specific target organ
toxicant (specific organ specified), following single exposure,
repeated exposure, or both when at least one ingredient has been
classified as a Category 1 or Category 2 specific target organ
toxicant and is present at or above the appropriate cut-off value/
concentration limit specified in Table A.9.3 for Category 1 and 2
respectively.
Table A.9.3--Cut-Off Value/Concentration Limits of Ingredients of a
Mixture Classified as a Specific Target Organ Toxicant That Would
Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
Cut-off values/concentration limits
triggering classification of a
Ingredient classified as mixture as
-------------------------------------
Category 1 Category 2
------------------------------------------------------------------------
Category 1 Target organ toxicant.. >=1.0% .................
Category 2 Target organ toxicant.. ................. >=1.0%
------------------------------------------------------------------------
A.9.3.4.2 These cut-off values and consequent classifications
shall be applied equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.9.3.4.3 Mixtures shall be classified for either or both
single- and repeated-dose toxicity independently.
A.9.3.4.4 Care shall be exercised when toxicants affecting more
than one organ system are combined that the potentiation or
synergistic interactions are considered, because certain substances
can cause specific target organ toxicity at <1% concentration when
other ingredients in the mixture are known to potentiate its toxic
effect.
A.10 Aspiration Hazard
A.10.1 Definitions and General Considerations
A.10.1.1 Aspiration hazard refers to severe acute effects such
as chemical pneumonia, pulmonary injury or death occurring after
aspiration of a substance or mixture.
A.10.1.2 Aspiration means the entry of a liquid or solid
chemical directly through the oral or nasal cavity, or indirectly
from vomiting, into the trachea and lower respiratory system.
A.10.1.3 Aspiration is initiated at the moment of inspiration,
in the time required to take one breath, as the causative material
lodges at the crossroad of the upper respiratory and digestive
tracts in the laryngopharyngeal region.
A.10.1.4 Aspiration of a substance or mixture can occur as it is
vomited following ingestion. This may have consequences for
labeling, particularly where, due to acute toxicity, a
recommendation may be considered to induce vomiting after ingestion.
However, if the substance/mixture also presents an aspiration
toxicity hazard, the recommendation to induce vomiting may need to
be modified.
A.10.1.5 Specific Considerations
A.10.1.5.1 The classification criteria refer to kinematic
viscosity. The following provides the conversion between dynamic and
kinematic viscosity:
[GRAPHIC] [TIFF OMITTED] TR20MY24.229
A.10.1.5.2 Although the definition of aspiration in A.10.1.1
includes the entry of solids into the respiratory system,
classification according to (b) in table A.10.1 for Category 1 is
intended to apply to liquid substances and mixtures only.
A.10.1.5.3 Classification of aerosol/mist products
Aerosol and mist products are usually dispensed in containers
such as self- pressurized containers, trigger and pump sprayers.
Classification for these products shall be considered if their use
may form a pool of product in the mouth, which then may be
aspirated. If the mist or aerosol from a pressurized container is
fine, a pool may not be formed. On the other hand, if a pressurized
container dispenses product in a stream, a pool may be formed that
may then be aspirated. Usually, the mist produced by trigger and
pump sprayers is coarse and therefore, a pool may be formed that
then may be aspirated. When the pump mechanism may be removed and
contents are
available to be swallowed then the classification of the products
should be considered.
A.10.2 Classification Criteria for Substances
Table A.10.1--Criteria for Aspiration Toxicity
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
Category 1: Chemicals known to A substance shall be classified in
cause human aspiration toxicity Category 1:
hazards or to be regarded as if (a) If reliable and good quality
they cause human aspiration human evidence indicates that it
toxicity hazard. causes aspiration toxicity (See
note); or
(b) If it is a hydrocarbon and has a
kinematic viscosity <=20.5 mm2/s,
measured at 40 [deg]C.
------------------------------------------------------------------------
Note: Examples of substances included in Category 1 are certain
hydrocarbons, turpentine and pine oil.
A.10.3 Classification Criteria for Mixtures
A.10.3.1 Classification When Data Are Available for the Complete
Mixture
A mixture shall be classified in Category 1 based on reliable
and good quality human evidence.
A.10.3.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.10.3.2.1 Where the mixture itself has not been tested to
determine its aspiration toxicity, but there are sufficient data on
both the individual ingredients and similar tested mixtures to
adequately characterize the hazard of the mixture, these data shall
be used in accordance with the following bridging principles as
found in paragraph A.0.5 of this Appendix: Dilution; Batching;
Concentration of mixtures; Interpolation within one hazard category;
and Substantially similar mixtures. For application of the dilution
bridging principle, the concentration of aspiration toxicants shall
not be less than 10%.
A.10.3.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.10.3.3.1 The ``relevant ingredients'' of a mixture are those
which are present in concentrations >=1%.
A.10.3.3.2 Category 1
A.10.3.3.2.1 A mixture is classified as Category 1 when the sum
of the concentrations of Category 1 ingredients is >=10%, and the
mixture has a kinematic viscosity of <=20.5 mm\2\/s, measured at 40
[deg]C.
A.10.3.3.2.2 In the case of a mixture which separates into two
or more distinct layers, the entire mixture is classified as
Category 1 if in any distinct layer the sum of the concentrations of
Category 1 ingredients is >=10%, and it has a kinematic viscosity of
<=20.5 mm\2\/s, measured at 40 [deg]C.
Appendix B to Sec. 1910.1200--Physical Hazard Criteria (Mandatory)
B.1 Explosives
B.1.1 Definitions and General Considerations
B.1.1.1 An explosive chemical is a solid or liquid chemical
which is in itself capable by chemical reaction of producing gas at
such a temperature and pressure and at such a speed as to cause
damage to the surroundings. Pyrotechnic chemicals are included even
when they do not evolve gases.
A pyrotechnic chemical is a chemical designed to produce an
effect by heat, light, sound, gas or smoke or a combination of these
as the result of non-detonative self-sustaining exothermic chemical
reactions.
An explosive item is an item containing one or more explosive
chemicals.
A pyrotechnic item is an item containing one or more pyrotechnic
chemicals.
An unstable explosive is an explosive which is thermally
unstable and/or too sensitive for normal handling, transport, or
use.
An intentional explosive is a chemical or item which is
manufactured with a view to produce a practical explosive or
pyrotechnic effect.
B.1.1.2 The class of explosives comprises:
(a) Explosive chemicals;
(b) Explosive items, except devices containing explosive
chemicals in such quantity or of such a character that their
inadvertent or accidental ignition or initiation shall not cause any
effect external to the device either by projection, fire, smoke,
heat or loud noise; and
(c) Chemicals and items not included under (a) and (b) of this
section which are manufactured with the view to producing a
practical explosive or pyrotechnic effect.
B.1.2 Classification Criteria
Chemicals and items of this class shall be classified as
unstable explosives or shall be assigned to one of the following six
divisions depending on the type of hazard they present:
(a) Division 1.1--Chemicals and items which have a mass
explosion hazard (a mass explosion is one which affects almost the
entire quantity present virtually instantaneously);
(b) Division 1.2--Chemicals and items which have a projection
hazard but not a mass explosion hazard;
(c) Division 1.3--Chemicals and items which have a fire hazard
and either a minor blast hazard or a minor projection hazard or
both, but not a mass explosion hazard:
(i) Combustion of which gives rise to considerable radiant heat;
or
(ii) Which burn one after another, producing minor blast or
projection effects or both;
(d) Division 1.4--Chemicals and items which present no
significant hazard: chemicals and items which present only a small
hazard in the event of ignition or initiation. The effects are
largely confined to the package and no projection of fragments of
appreciable size or range is to be expected. An external fire shall
not cause virtually instantaneous explosion of almost the entire
contents of the package;
(e) Division 1.5--Very insensitive chemicals which have a mass
explosion hazard: chemicals which have a mass explosion hazard but
are so insensitive that there is very little probability of
initiation or of transition from burning to detonation under normal
conditions;
(f) Division 1.6--Extremely insensitive items which do not have
a mass explosion hazard: items which predominantly contain extremely
insensitive detonating chemicals and which demonstrate a negligible
probability of accidental initiation or propagation.
B.1.3 Additional Classification Considerations
B.1.3.1 Explosives shall be classified as unstable explosives or
shall be assigned to one of the six divisions identified in B.1.2 in
accordance with the three step procedure in Part I of UN ST/SG/AC.10
(incorporated by reference, see Sec. 1910.6). The first step is to
ascertain whether the substance or mixture has explosive effects
(Test Series 1). The second step is the acceptance procedure (Test
Series 2 to 4) and the third step is the assignment to a hazard
division (Test Series 5 to 7). The assessment whether a candidate
for ``ammonium nitrate emulsion or suspension or gel, intermediate
for blasting explosives (ANE)'' is insensitive enough for inclusion
as an oxidizing liquid (see B.13 of this appendix) or an oxidizing
solid (see B.14 of this appendix) is determined by Test Series 8
tests of UN ST/SG/AC.10/.
Note 1: Classification of solid chemicals shall be based on
tests performed on the chemical as presented. If, for example, for
the purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
Note 2: Some explosive chemicals are wetted with water or
alcohols, diluted with other substances or dissolved or suspended in
water or other liquid substances to suppress or reduce their
explosive properties or sensitivity.
These chemicals shall be classified as desensitized explosives
(see Chapter B.17).
Note 3: Chemicals with a positive result in Test Series 2 in
Part I, Section 12 of UN ST/SG/AC.10/11/Rev.6 (incorporated by
reference; see Sec. 1910.6) which are exempted from classification
as explosives (based on a negative result in Test Series 6 in Part
I, Section 16 of UN ST/SG/AC.10/11/Rev.6 (incorporated by reference;
see Sec. 1910.6)), still have explosive properties. The explosive
properties of the chemical shall be communicated in Section 2
(Hazard identification) and Section 9 (Physical and chemical
properties) of the Safety Data Sheet, as appropriate.
B.1.3.2 Explosive properties are associated with the presence of
certain chemical groups in a molecule which can react to produce
very rapid increases in temperature or pressure. The screening
procedure in B.1.3.1 is aimed at identifying the presence of such
reactive groups and the potential for rapid energy release. If the
screening procedure identifies the chemical as a potential
explosive, the acceptance procedure (see section 10.3 of the UN ST/
SG/AC.10 (incorporated by reference; see Sec. 1910.6)) is necessary
for classification.
Note: Neither a Series 1 type (a) propagation of detonation
test nor a Series 2 type (a) test of sensitivity to detonative shock
is necessary if the exothermic decomposition energy of organic
materials is less than 800 J/g.
B.1.3.3 If a mixture contains any known explosives, the
acceptance procedure is necessary for classification.
B.1.3.4 A chemical is not classified as explosive if:
(a) There are no chemical groups associated with explosive
properties present in the molecule. Examples of groups which may
indicate explosive properties are given in Table A6.1 in Appendix 6
of the UN ST/SG/AC.10 (incorporated by reference; See Sec. 1910.6);
or
(b) The substance contains chemical groups associated with
explosive properties which include oxygen and the calculated oxygen
balance is less than -200.
The oxygen balance is calculated for the chemical reaction:
CxHyOz + [x + (y/4)-(z/2)] O2 [rarr] x. CO2 + (y/2)
H2O
using the formula: oxygen balance = -1600 [2x + (y/2)-z]/molecular
weight; or
(c) The organic substance or a homogenous mixture of organic
substances contains chemical groups associated with explosive
properties but the exothermic decomposition energy is less than 500
J/g and the onset of exothermic decomposition is below 500 [deg]C
(932 [deg]F). The exothermic decomposition energy may be determined
using a suitable calorimetric technique; or
(d) For mixtures of inorganic oxidizing substances with organic
material(s), the concentration of the inorganic oxidizing substance
is:
(i) less than 15%, by mass, if the oxidizing substance is
assigned to Category 1 or 2;
(ii) less than 30%, by mass, if the oxidizing substance is
assigned to Category 3.
B.2 Flammable Gases
B.2.1 Definition
Flammable gas means a gas having a flammable range with air at
20 [deg]C (68 [deg]F) and a standard pressure of 101.3 kPa (14.7
psi).
A pyrophoric gas means a flammable gas that is liable to ignite
spontaneously in air at a temperature of 54 [deg]C (130 [deg]F) or
below.
A chemically unstable gas means a flammable gas that is able to
react explosively even in the absence of air or oxygen.
B.2.2 Classification Criteria
B.2.2.1 A flammable gas shall be classified in Category 1A, 1B,
or 2 in accordance with Table B.2.1:
Table B.2.1--Criteria for Flammable Gases
----------------------------------------------------------------------------------------------------------------
Category Criteria
----------------------------------------------------------------------------------------------------------------
1A......................... Flammable gas............... Gases, which at 20 [deg]C (68 [deg]F) and a standard
pressure of 101.3 kPa (14.7 psi):
(a) are ignitable when in a mixture of 13% or less by
volume in air; or
(b) have a flammable range with air of at least 12
percentage points regardless of the lower
flammability limit,
unless data show they meet the criteria for Category
1B.
Pyrophoric gas.............. Flammable gases that ignite spontaneously in air at a
temperature of 54 [deg]C (130 [deg]F) or below.
Chemically unstable gas:
A........................ Flammable gases which are chemically unstable at 20
[deg]C (68 [deg]F) and a standard pressure of 101.3
kPa (14.7 psi).
B........................ Flammable gases which are chemically unstable at a
temperature greater than 20 [deg]C (68 [deg]F) and/
or a pressure greater than 101.3 kPa (14.7 psi).
1B......................... Flammable gas............... Gases which meet the flammability criteria for
Category 1A, but which are not pyrophoric, nor
chemically unstable, and which have at least either:
(a) a lower flammability limit of more than 6% by
volume in air; or
(b) a fundamental burning velocity of less than 10 cm/
s.
2.......................... Flammable gas............... Gases, other than those of Category 1A or 1B, which,
at 20 [deg]C (68 [deg]F) and a standard pressure of
101.3 kPa (14.7 psi), have a flammable range while
mixed in air.
----------------------------------------------------------------------------------------------------------------
Note 1: Aerosols should not be classified as flammable gases.
See B.3.
Note 2: In the absence of data allowing classification into
Category 1B, a flammable gas that meets the criteria for Category 1A
shall be classified by default in Category 1A.
Note 3: Spontaneous ignition for pyrophoric gases is not always
immediate, and there may be a delay.
Note 4: In the absence of data on its pyrophoricity, a
flammable gas mixture shall be classified as a pyrophoric gas if it
contains more than 1% (by volume) of pyrophoric component(s).
B.2.3 Additional Classification Considerations
B.2.3.1 Flammability shall be determined by tests or by
calculation in accordance with ISO 10156:1996 or ISO 10156:2017
(incorporated by reference; see Sec. 1910.6) and, if using
fundamental burning velocity for Category 1B, use Annex C: Method of
test for burning velocity measurement of flammable gases of ISO
817:2014(E) (incorporated by reference; see Sec. 1910.6). Where
insufficient data are available to use this method, equivalent
validated methods may be used.
B.2.3.2 Pyrophoricity shall be determined at 130 [deg]F (54
[deg]C) in accordance with either IEC 60079-20-1 or DIN 51794:2003
(incorporated by reference; see Sec. 1910.6).
B.2.3.3 The classification procedure for pyrophoric gases need
not be applied when experience in production or handling shows that
the substance does not ignite spontaneously on coming into contact
with air at a temperature of 130 [deg]F (54 [deg]C) or below.
Flammable gas mixtures, which have not been tested for pyrophoricity
and which contain more than one percent pyrophoric components shall
be classified as a pyrophoric gas. Expert judgement on the
properties and physical hazards of pyrophoric gases and their
mixtures should be used in assessing the need for classification of
flammable gas mixtures containing one percent or less pyrophoric
components. In this case, testing need only be considered if expert
judgement indicates a need for additional data to support the
classification process.
B.2.3.4 Chemical instability shall be determined in accordance
with the method described in Part III of the UN ST/SG/AC.10/11/Rev.6
(incorporated by reference; see Sec. 1910.6). If the calculations
performed in accordance with ISO 10156:1996 or ISO 10156:2017
(incorporated by reference; see Sec. 1910.6) show that a gas
mixture is not flammable, no additional testing is required
for determining chemical instability for classification purposes.
B.3 Aerosols and Chemicals Under Pressure
B.3.1 Aerosols
B.3.1.1 Definition
Aerosol means any non-refillable receptacle containing a gas
compressed, liquefied or dissolved under pressure, and fitted with a
release device allowing the contents to be ejected as particles in
suspension in a gas, or as a foam, paste, powder, liquid or gas.
B.3.1.2 Classification Criteria
B.3.1.2.1 Aerosols are classified in one of three categories,
depending on their flammable properties and their heat of
combustion. Aerosols shall be considered for classification in
Categories 1 or 2 if they contain more than 1% components (by mass)
which are classified as flammable in accordance with this Appendix
B, i.e.:
Flammable gases (see B.2);
Flammable liquids (see B.6)
Flammable solids (see B.7)
or if their heat of combustion is at least 20 kJ/g.
B.3.1.2.2 An aerosol shall be classified in one of the three
categories for this class in accordance with Table B.3.1.
Table B.3.1--Criteria for Aerosols
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1................................. Contains >=85% flammable components
and the chemical heat of combustion
is >=30 kJ/g; or
(a) For spray aerosols, in the
ignition distance test, ignition
occurs at a distance >=75 cm
(29.5 in), or
(b) For foam aerosols, in the
aerosol foam flammability test.
(i) The flame height is >=20 cm
(7.87 in) and the flame
duration >=2 s; or
(ii) The flame height is >=4 cm
(1.57 in) and the flame
duration >=7 s.
2................................. Contains >1% flammable components,
or the heat of combustion is >=20
kJ/g; and
(a) for spray aerosols, in the
ignition distance test, ignition
occurs at a distance >=15 cm
(5.9 in), or
in the enclosed space ignition
test, the
(i) Time equivalent is <=300 s/
m\3\; or
(ii) Deflagration density is
<=300 g/m\3\
(b) For foam aerosols, in the
aerosol foam flammability test,
the flame height is >=4 cm and
the flame duration is >=2 s
and it does not meet the criteria
for Category 1.
3................................. (1) The chemical does not meet the
criteria for Categories 1 and 2.
(2) The chemical contains <=1%
flammable components (by mass) and
has a heat of combustion <20 kJ/g.
------------------------------------------------------------------------
Note 1: Flammable components do not include pyrophoric, self-
heating or water-reactive chemicals.
Note 2: Aerosols do not fall additionally within the scope of
flammable gases, gases under pressure, flammable liquids, or
flammable solids. However, depending on their contents, aerosols may
fall within the scope of other hazard classes.
Note 3: Aerosols containing more than 1% flammable components
or with a heat of combustion of at least 20 kJ/g, which are not
submitted to the flammability classification procedures in this
Appendix shall be classified as Category 1.
B.3.2 Chemicals Under Pressure
B.3.2.1 Definition
Chemicals under pressure are liquids or solids (e.g., pastes or
powders), pressurized with a gas at a pressure of 200 kPa (gauge) or
more at 20 [deg]C in pressure receptacles other than aerosol
dispensers and which are not classified as gases under pressure.
Note: Chemicals under pressure typically contain 50% or more by
mass of liquids or solids whereas mixtures containing more than 50%
gases are typically considered as gases under pressure.
B.3.2.2 Classification Criteria
B.3.2.2.1 Chemicals under pressure are classified in one of
three categories of this hazard class, in accordance with Table
B.3.2, depending on their content of flammable components and their
heat of combustion
B.3.2.2.2 Flammable components are components which are
classified as flammable in accordance with the GHS criteria, i.e.:
--Flammable gases (see B..2 of this section);
--Flammable liquids (see B.6 of this section);
--Flammable solids (see B.7 of this section).
Table B.3.2--Criteria for Chemicals Under Pressure
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1................................. Any chemical under pressure that:
(a) contains >=85% flammable
components (by mass); and
(b) has a heat of combustion of >=20
kJ/g.
2................................. Any chemical under pressure that:
(a) contains >1% flammable
components (by mass); and
(b) has a heat of combustion <20 kJ/
g;
or that:
(a) contains <85% flammable
components (by mass); and
(b) has a heat of combustion >=20 kJ/
g.
3................................. Any chemical under pressure that:
(a) contains <=1% flammable
components (by mass); and
(b) has a heat of combustion of <20
kJ/g.
------------------------------------------------------------------------
Note 1: The flammable components in a chemical under pressure
do not include pyrophoric, self-heating or water-reactive,
substances and mixtures because such components are not allowed in
chemicals under pressure in accordance with the UN Model
Regulations.
Note 2: Chemicals under pressure do not fall additionally within
the scope of section B.3.1 (aerosols), B.2.2 (flammable gases),
B.2.5 (gases under pressure), B.2.6 (flammable liquids) and B.2.7
(flammable solids). Depending on their contents, chemicals under
pressure may however fall within the scope of other hazard classes,
including their labelling elements.
B.3.3 Additional Classification Considerations
B.3.3.1 To classify an aerosol, data on its flammable
components, on its chemical heat of combustion and, if applicable,
the results
of the aerosol foam flammability test (for foam aerosols) and of the
ignition distance test and enclosed space test (for spray aerosols)
are necessary.
B.3.3.2 The chemical heat of combustion ([Delta]Hc), in
kilojoules per gram (kJ/g), is the product of the theoretical heat
of combustion ([Delta]Hcomb), and a combustion efficiency, usually
less than 1.0 (a typical combustion efficiency is 0.95 or 95%).
For a composite formulation, the chemical heat of combustion is
the summation of the weighted heats of combustion for the individual
components, as follows:
[GRAPHIC] [TIFF OMITTED] TR20MY24.230
where:
[Delta]Hc(product) = specific heat of combustion (kJ/g)
of the product;
[Delta]Hc(i) = specific heat of combustion (kJ/g) of
component i in the product;
w(i) = mass fraction of component i in the product;
n = total number of components in the product.
B.3.3.3 The chemical heats of combustion shall be found in
literature, calculated or determined by tests: (see ASTM D240;
Sections 86.1 to 86.3 of ISO 13943; and NFPA 30B (incorporated by
reference; see Sec. 1910.6)).
B.3.3.4 The Ignition Distance Test, Enclosed Space Ignition Test
and Aerosol Foam Flammability Test shall be performed in accordance
with sub-sections 31.4, 31.5 and 31.6 of UN ST/SG/AC.10
(incorporated by reference; see Sec. 1910.6).
B.4 Oxidizing Gases
B.4.1 Definition
Oxidizing gas means any gas which may, generally by providing
oxygen, cause or contribute to the combustion of other material more
than air does.
Note: ``Gases which cause or contribute to the combustion of
other material more than air does'' means pure gases or gas mixtures
with an oxidizing power greater than 23.5% (as determined by a
method specified in ISO 10156:1996, ISO 10156:2017 or 10156-2:2005
(incorporated by reference; see Sec. 1910.6) or an equivalent
testing method).
B.4.2 Classification Criteria
An oxidizing gas shall be classified in a single category for
this class in accordance with Table B.4.1:
Table B.4.1--Criteria for Oxidizing Gases
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1...................................... Any gas which may, generally by
providing oxygen, cause or
contribute to the combustion
of other material more than
air does.
------------------------------------------------------------------------
B.4.3 Additional Classification Considerations
Classification shall be in accordance with tests or calculation
methods as described in ISO 10156:1996, ISO 10156:2017 or 10156-
2:2005 (incorporated by reference; see Sec. 1910.6).
B.5 Gases Under Pressure
B.5.1 Definition
Gases under pressure are gases which are contained in a
receptacle at a pressure of 200 kPa (29 psi) (gauge) or more at 20
[deg]C (68 [deg]F), or which are liquefied or liquefied and
refrigerated.
They comprise compressed gases, liquefied gases, dissolved gases
and refrigerated liquefied gases.
B.5.2 Classification Criteria
Gases under pressure shall be classified in one of four groups
in accordance with Table B.5.1:
Table B.5.1--Criteria for Gases Under Pressure
----------------------------------------------------------------------------------------------------------------
Group Criteria
----------------------------------------------------------------------------------------------------------------
Compressed Gas.............................. A gas which when inder pressure is entirely gaseous at -50 [deg]C
(-58 [deg]F), including all gases with a critical temperature \1\
<=-50 [deg]C (-58 [deg]F)
Liquedfied gas.............................. A gas which when inder pressure, is partially liquid at
termperatures above -50 [deg]C (-58 [deg]F) A disinction is made
between:
(a) High pressure liquefied gas: a gas with a critical
termperature \1\ between -50 [deg]C (-58 [deg]F) and +65
[deg]C (149 [deg]F); and
(b) Low pressure liquefied gas: a gas with a critical
temperature \1\ above +65 [deg]C (149 [deg]F)
Refrigerated liquefied gas.................. A gas which is made partially liquid becuase of its low
temperature.
Dissolved gas............................... A gas which when under pressure is dissolved in a liquid phase
solvent.
----------------------------------------------------------------------------------------------------------------
\1\ The critical temperature is the temperature above which a pure gas cannot be liquefied, regardless of the
degree of compression.
Note: Aerosols should not be classified as gases under pressure.
See Appendix B.3 of this section.
B.6 Flammable Liquids
B.6.1 Definition
Flammable liquid means a liquid having a flash point of not more
than 93 [deg]C (199.4 [deg]F).
Flash point means the minimum temperature at which a liquid
gives off vapor in sufficient concentration to form an ignitable
mixture with air near the surface of the liquid, as determined by a
method identified in Section B.6.3 of this appendix.
B.6.2 Classification Criteria
A flammable liquid shall be classified in one of four categories
in accordance with Table B.6.1 of this appendix:
Table B.6.1--Criteria for Flammable Liquids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1...................................... Flash point <23 [deg]C (73.4
[deg]F) and initial boiling
point <=35 [deg]C (95 [deg]F).
2...................................... Flash point <23 [deg]C (73.4
[deg]F) and initial boiling
point >35 [deg]C (95 [deg]F).
3...................................... Flash point >=23 [deg]C (73.4
[deg]F) and <=60 [deg]C (140
[deg]F).
4...................................... Flash point >60 [deg]C (140
[deg]F) and <=93 [deg]C (199.4
[deg]F).
------------------------------------------------------------------------
Note: Aerosols should not be classified as flammable liquids.
See Appendix B.3 of this section.
B.6.3 Additional Classification Considerations
The flash point shall be determined in accordance with ASTM D56-
05, ASTM D3278, ASTM D3828, ASTM D93-08 (incorporated by reference,
see Sec. 1910.6), or any method specified in 29 CFR
1910.106(a)(14). It may also be determined by any other method
specified in GHS Revision 7, Chapter 2.6.
The initial boiling point shall be determined in accordance with
ASTM D86-
07a or ASTM D1078 (incorporated by reference; see Sec. 1910.6).\9\
---------------------------------------------------------------------------
\9\ To determine the appropriate flammable liquid storage
container size and type, the boiling point shall be determined by
Sec. 1910.106(a)(5). In addition, the manufacturer, importer, and
distributor shall clearly note in sections 7 and 9 of the SDS if an
alternate calculation was used for storage purposes and the
classification for storage differs from the classification listed in
Section 2 of the SDS.
---------------------------------------------------------------------------
B.7 Flammable Solids
B.71 Definitions
Flammable solid means a solid which is a readily combustible
solid, or which may cause or contribute to fire through friction.
Readily combustible solids are powdered, granular, or pasty
chemicals which are dangerous if they can be easily ignited by brief
contact with an ignition source, such as a burning match, and if the
flame spreads rapidly.
B.7.2 Classification Criteria
B.7.2.1 Powdered, granular or pasty chemicals shall be
classified as flammable solids when the time of burning of one or
more of the test runs, performed in accordance with the test method
described in Part III, sub-section 33.2.1 of UN ST/SG/AC.10
(incorporated by reference; see Sec. 1910.6), is less than 45 s or
the rate of burning is more than 2.2 mm/s (0.0866 in/s).
B.7.2.2 Powders of metals or metal alloys shall be classified as
flammable solids when they can be ignited and the reaction spreads
over the whole length of the sample in 10 min or less.
B.7.2.3 Solids which may cause fire through friction shall be
classified in this class by analogy with existing entries (e.g.,
matches) until definitive criteria are established.
B.7.2.4 A flammable solid shall be classified in one of the two
categories for this class using Method N.1 as described in Part III,
sub-section 33.2.1 of UN ST/SG/AC.10 (incorporated by reference; see
Sec. 1910.6), in accordance with Table B.7.1:
Table B.7.1--Criteria for Flammable Solids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1................................ Burning rate test:
Chemicals other than metal
powders:
(a) Wetted zone does not stop
fire; and
(b) Burning time <45 s or
burning rate >2.2 mm/s
Metal powders: burning time <=5
min.
2................................ Burning rate test:
Chemicals other than metal
powders:
(a) Wetted zone stops the fire
for at least 4 min; and
(b) Burning time <45 s or
burning rate >2.2 mm/s
Metal powders: burning time >5 min
and <=10 min.
------------------------------------------------------------------------
Note 1: Classification of solid chemicals shall be based on
tests performed on the chemical as presented. If, for example, for
the purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
Note 2: Aerosols should not be classified as flammable solids.
See Appendix B.3.
B.8 Self-Reactive Chemicals
B.8.1 Definitions
Self-reactive chemicals are thermally unstable liquid or solid
chemicals liable to undergo a strongly exothermic decomposition even
without participation of oxygen (air). This definition excludes
chemicals classified under this section as explosives, organic
peroxides, oxidizing liquids or oxidizing solids.
A self-reactive chemical is regarded as possessing explosive
properties when in laboratory testing the formulation is liable to
detonate, to deflagrate rapidly or to show a violent effect when
heated under confinement.
B.8.2 Classification Criteria
B.8.2.1 A self-reactive chemical shall be considered for
classification in this class unless:
(a) It is classified as an explosive according to B.1 of this
appendix;
(b) It is classified as an oxidizing liquid or an oxidizing
solid according to B.13 or B.14 of this appendix, except that a
mixture of oxidizing substances which contains 5% or more of
combustible organic substances shall be classified as a self-
reactive chemical according to the procedure defined in B.8.2.2;
(c) It is classified as an organic peroxide according to B.15 of
this appendix;
(d) Its heat of decomposition is less than 300 J/g; or
(e) Its self-accelerating decomposition temperature (SADT) is
greater than 75[deg] C (167 [deg]F) for a 50 kg (110 lb) package.
B.8.2.2 Mixtures of oxidizing substances, meeting the criteria
for classification as oxidizing liquids or oxidizing solids, which
contain 5% or more of combustible organic substances and which do
not meet the criteria mentioned in B.8.2.1(a), (c), (d) or (e),
shall be subjected to the self-reactive chemicals classification
procedure in B.8.2.3. Such a mixture showing the properties of a
self-reactive chemical type B to F shall be classified as a self-
reactive chemical.
B.8.2.3 Self-reactive chemicals shall be classified in one of
the seven categories of ``types A to G'' for this class, according
to the following principles:
(a) Any self-reactive chemical which can detonate or deflagrate
rapidly, as packaged, will be defined as self-reactive chemical TYPE
A;
(b) Any self-reactive chemical possessing explosive properties
and which, as packaged, neither detonates nor deflagrates rapidly,
but is liable to undergo a thermal explosion in that package will be
defined as self-reactive chemical TYPE B;
(c) Any self-reactive chemical possessing explosive properties
when the chemical as packaged cannot detonate or deflagrate rapidly
or undergo a thermal explosion will be defined as self-reactive
chemical TYPE C;
(d) Any self-reactive chemical which in laboratory testing meets
the criteria in (d)(i), (ii), or (iii) will be defined as self-
reactive chemical TYPE D:
(i) Detonates partially, does not deflagrate rapidly and shows
no violent effect when heated under confinement; or
(ii) Does not detonate at all, deflagrates slowly and shows no
violent effect when heated under confinement; or
(iii) Does not detonate or deflagrate at all and shows a medium
effect when heated under confinement;
(e) Any self-reactive chemical which, in laboratory testing,
neither detonates nor deflagrates at all and shows low or no effect
when heated under confinement will be defined as self-reactive
chemical TYPE E;
(f) Any self-reactive chemical which, in laboratory testing,
neither detonates in the cavitated state nor deflagrates at all and
shows only a low or no effect when heated under confinement as well
as low or no explosive power will be defined as self-reactive
chemical TYPE F;
(g) Any self-reactive chemical which, in laboratory testing,
neither detonates in the cavitated state nor deflagrates at all and
shows no effect when heated under confinement nor any explosive
power, provided that it is thermally stable (self- accelerating
decomposition temperature is 60 [deg]C (140 [deg]F) to 75[deg] C
(167 [deg]F) for a 50 kg (110 lb) package), and, for liquid
mixtures, a diluent having a boiling point greater than or equal to
150 [deg]C (302 [deg]F) is used for desensitization will be defined
as self-reactive chemical TYPE G. If the mixture is not thermally
stable or a diluent having a boiling point less than 150 [deg]C (302
[deg]F) is used for desensitization, the mixture shall be defined as
self-reactive chemical TYPE F.
B.8.3 Additional Classification Considerations
B.8.3.1 For purposes of classification, the properties of self-
reactive chemicals shall be determined in accordance with test
series A to H as described in Part II of UN ST/SG/AC.10
(incorporated by reference; see Sec. 1910.6).
B.8.3.2 Self-accelerating decomposition temperature (SADT) shall
be determined in accordance with Part II, section 28 of UN ST/SG/
AC.10, (incorporated by reference; see Sec. 1910.6).
B.8.3.3 The classification procedures for self-reactive
substances and mixtures need not be applied if:
(a) There are no chemical groups present in the molecule
associated with explosive or self-reactive properties; examples of
such groups are given in Tables A6.1 and A6.2 in the Appendix 6 of
UN ST/SG/AC.10 (incorporated by reference; see Sec. 1910.6); or
(b) For a single organic substance or a homogeneous mixture of
organic substances, the estimated SADT is greater than 75[deg]C (167
[deg]F) or the exothermic decomposition energy is less than 300 J/g.
The onset temperature and decomposition energy may
be estimated using a suitable calorimetric technique (See 20.3.3.3
in Part II of UN ST/SG/AC.10 (incorporated by reference; see Sec.
1910.6)).
B.9 Pyrophoric Liquids
B.9.1 Definition
Pyrophoric liquid means a liquid which, even in small
quantities, is liable to ignite within five minutes after coming
into contact with air.
B.9.2 Classification Criteria
A pyrophoric liquid shall be classified in a single category for
this class using test N.3 in Part III, sub-section 33.3.1.5 of UN
ST/SG/AC.10 (incorporated by reference; see Sec. 1910.6), in
accordance with Table B.9.1 of this appendix:
Table B.9.1-- Criteria for Pyrophoric Liquids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1................................. The liquid ignites within 5 min when
added to an inert carrier and
exposed to air, or it ignites or
chars a filter paper on contact
with air within 5 min.
------------------------------------------------------------------------
B.9.3 Additional Classification Considerations
The classification procedure for pyrophoric liquids need not be
applied when experience in production or handling shows that the
chemical does not ignite spontaneously on coming into contact with
air at normal temperatures (i.e., the substance is known to be
stable at room temperature for prolonged periods of time (days)).
B.10 Pyrophoric Solids
B.10.1 Definition
Pyrophoric solid means a solid which, even in small quantities,
is liable to ignite within five minutes after coming into contact
with air.
B.10.2 Classification Criteria
A pyrophoric solid shall be classified in a single category for
this class using test N.2 in Part III, sub-section 33.3.1.4 of UN
ST/SG/AC.10 (incorporated by reference; see Sec. 1910.6), in
accordance with Table B.10.1 of this appendix:
Table B.10.1-- Criteria for Pyrophoric Solids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1................................. The solid ignites within 5 min of
coming into contact with air.
------------------------------------------------------------------------
Note: Classification of solid chemicals shall be based on tests
performed on the chemical as presented. If, for example, for the
purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.10.3 Additional Classification Considerations
The classification procedure for pyrophoric solids need not be
applied when experience in production or handling shows that the
chemical does not ignite spontaneously on coming into contact with
air at normal temperatures (i.e., the chemical is known to be stable
at room temperature for prolonged periods of time (days)).
B.11--Self-Heating Chemicals
B.11.1 Definition
A self-heating chemical is a solid or liquid chemical, other
than a pyrophoric liquid or solid, which, by reaction with air and
without energy supply, is liable to self-heat; this chemical differs
from a pyrophoric liquid or solid in that it will ignite only when
in large amounts (kilograms) and after long periods of time (hours
or days).
Note: Self-heating of a substance or mixture is a process where
the gradual reaction of that substance or mixture with oxygen (in
air) generates heat. If the rate of heat production exceeds the rate
of heat loss, then the temperature of the substance or mixture will
rise which, after an induction time, may lead to self-ignition and
combustion.
B.11.2 Classification Criteria
B.11.2.1 A self-heating chemical shall be classified in one of
the two categories for this class if, in tests performed in
accordance with test method N.4 in Part III, sub-section 33.3.1.6 of
UN ST/SG/AC.10 (incorporated by reference, see Sec. 1910.6), the
result meets the criteria shown in Table B.11.1.
Table B.11.1-- Criteria for Self-Heating Chemicals
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1................................ A positive result is obtained in a
test using a 25 mm sample cube at
140 [deg] C (284 [deg] F).
2................................ A negative result is obtained in a
test using a 25 mm cube sample at
140 [deg] C (284 [deg] F), a
positive result is obtained in a
test using a 100 mm sample cube at
140 [deg] C (284 [deg] F), and:
(a) The unit volume of the
chemical is more than 3 m3; or
(b) A positive result is obtained
in a test using a 100 mm cube
sample at 120 [deg] C (248 [deg]
F) and the unit volume of the
chemical is more than 450 liters;
or
(c) A positive result is obtained
in a test using a 100 mm cube
sample at 100 [deg] C (212 [deg]
F).
------------------------------------------------------------------------
Note: Classification of solid chemicals shall be based on tests
performed on the chemical as presented. If, for example, for the
purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.11.2.2 Chemicals with a temperature of spontaneous combustion
higher than 50 [deg] C (122 [deg] F) for a volume of 27 m3 shall not
be classified as self-heating chemicals.
B.11.2.3 Chemicals with a spontaneous ignition temperature
higher than 50[deg] C (122[deg] F) for a volume of 450 liters shall
not be classified in Category 1 of this class.
B.11.3 Additional Classification Considerations
B.11.3.1 The classification procedure for self-heating chemicals
need not be applied if the results of a screening test can be
adequately correlated with the classification test and an
appropriate safety margin is applied.
B.11.3.2 Examples of screening tests are:
(a) The Grewer Oven test (VDI guideline 2263, part 1, 1990, Test
methods for the Determination of the Safety Characteristics of
Dusts) with an onset temperature 80[deg]K above the reference
temperature for a volume of 1 l;
(b) The Bulk Powder Screening Test (Gibson, N. Harper, D. J.
Rogers, R. Evaluation of the fire and explosion risks in drying
powders, Plant Operations Progress, 4 (3), 181-189, 1985) with an
onset temperature 60[deg]K above the reference temperature for a
volume of 1 l.
B.12 Chemicals Which, in Contact With Water, Emit Flammable Gases
B.12.1 Definition
Chemicals which, in contact with water, emit flammable gases are
solid or liquid chemicals which, by interaction with water, are
liable to become spontaneously flammable or to give off flammable
gases in dangerous quantities.
B.12.2 Classification Criteria
B.12.2.1 A chemical which, in contact with water, emits
flammable gases shall be classified in one of the three categories
for this class, using test N.5 in Part III, sub-section 33.4.1.4 of
UN ST/SG/AC.10 (incorporated by reference, see Sec. 1910.6), in
accordance with Table B.12.1 of this appendix:
Table B.12.1-- Criteria for Chemicals Which, in Contact With Water, Emit
Flammable Gases
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1...................................... Any chemical which, in the 1:1
mixture, by mass, of chemical
and cellulose tested,
spontaneously ignites; or the
mean pressure rise time of a
1:1 mixture, by mass, of
chemical and cellulose is less
than that of a 1:1 mixture, by
mass, of 50% perchloric acid
and cellulose;
2...................................... Any chemical which, in the 1:1
mixture, by mass, of chemical
and cellulose tested, exhibits
a mean pressure rise time less
than or equal to the mean
pressure rise time of a 1:1
mixture, by mass, of 40%
aqueous sodium chlorate
solution and cellulose; and
the criteria for Category 1
are not met;
3...................................... Any chemical which, in the 1:1
mixture, by mass, of chemical
and cellulose tested, exhibits
a mean pressure rise time less
than or equal to the mean
pressure rise time of a 1:1
mixture, by mass, of 65%
aqueous nitric acid and
cellulose; and the criteria
for Categories 1 and 2 are not
met.
------------------------------------------------------------------------
Note: Classification of solid chemicals shall be based on tests
performed on the chemical as presented. If, for example, for the
purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.12.2.2 A chemical is classified as a chemical which, in
contact with water, emits flammable gases if spontaneous ignition
takes place in any step of the test procedure.
B.12.3 Additional Classification Considerations
The classification procedure for this class need not be applied
if:
(a) The chemical structure of the chemical does not contain
metals or metalloids;
(b) Experience in production or handling shows that the chemical
does not react with water, (e.g., the chemical is manufactured with
water or washed with water); or
(c) The chemical is known to be soluble in water to form a
stable mixture.
B.13 Oxidizing Liquids
B.13.1 Definition
Oxidizing liquid means a liquid which, while in itself not
necessarily combustible, may, generally by yielding oxygen, cause,
or contribute to, the combustion of other material.
B.13.2 Classification Criteria
An oxidizing liquid shall be classified in one of the three
categories for this class using test O.2 in Part III, sub-section
34.4.2 of UN ST/SG/AC.10 (incorporated by reference, see Sec.
1910.6), in accordance with Table B.13.1:
Table B.13.1-- Criteria for Oxidizing Liquids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1...................................... Any chemical which, in the 1:1
mixture, by mass, of chemical
and cellulose tested,
spontaneously ignites; or the
mean pressure rise time of a
1:1 mixture, by mass, of
chemical and cellulose is less
than that of a 1:1 mixture, by
mass, of 50% perchloric acid
and cellulose;
2...................................... Any chemical which, in the 1:1
mixture, by mass, of chemical
and cellulose tested, exhibits
a mean pressure rise time less
than or equal to the mean
pressure rise time of a 1:1
mixture, by mass, of 40%
aqueous sodium chlorate
solution and cellulose; and
the criteria for Category 1
are not met;
3...................................... Any chemical which, in the 1:1
mixture, by mass, of chemical
and cellulose tested, exhibits
a mean pressure rise time less
than or equal to the mean
pressure rise time of a 1:1
mixture, by mass, of 65%
aqueous nitric acid and
cellulose; and the criteria
for Categories 1 and 2 are not
met.
------------------------------------------------------------------------
B.13.3 Additional Classification Considerations
B.13.3.1 For organic chemicals, the classification procedure for
this class shall not be applied if:
(a) The chemical does not contain oxygen, fluorine or chlorine;
or
(b) The chemical contains oxygen, fluorine or chlorine and these
elements are chemically bonded only to carbon or hydrogen.
B.13.3.2 For inorganic chemicals, the classification procedure
for this class shall not be applied if the chemical does not contain
oxygen or halogen atoms.
B.13.3.3 In the event of divergence between test results and
known experience in the handling and use of chemicals which shows
them to be oxidizing, judgments based on known experience shall take
precedence over test results.
B.13.3.4 In cases where chemicals generate a pressure rise (too
high or too low), caused by chemical reactions not characterizing
the oxidizing properties of the chemical, the test described in Part
III, sub-section 34.4.2 of UN ST/SG/AC.10 (incorporated by
reference, see Sec. 1910.6) shall be repeated with an inert
substance (e.g., diatomite (kieselguhr)) in place of the cellulose
in order to clarify the nature of the reaction.
B.14 Oxidizing Solids
B.14.1 Definition
Oxidizing solid means a solid which, while in itself is not
necessarily combustible, may, generally by yielding oxygen, cause,
or contribute to, the combustion of other material.
B.14.2 Classification Criteria
An oxidizing solid shall be classified in one of the three
categories for this class using test O.1 in Part III, sub-section
34.4.1, of UN ST/SG/AC.10 (incorporated by reference, see Sec.
1910.6) or test O.3 in Part III, sub-section 34.4.3 of UN ST/SG/
AC.10/11 (incorporated by reference, see Sec. 1910.6), in
accordance with Table B.14.1:
Table B.14.1--Criteria for Oxidizing Solids
------------------------------------------------------------------------
Criteria using test Criteria using test
Category O.1 O.3
------------------------------------------------------------------------
1........................... Any chemical which, Any chemical which,
in the 4:1 or 1:1 in the 4:1 or 1:1
sample-to-cellulose sample-to-
ratio (by mass) cellulose ratio (by
tested, exhibits a mass) tested,
mean burning time exhibits a mean
less than the mean burning rate
burning time of a greater than the
3:2 mixture, (by mean burning rate
mass), of potassium of a 3:1 mixture
bromate and (by mass) of
cellulose. calcium peroxide
and cellulose.
2........................... Any chemical which, Any chemical which,
in the 4:1 or 1:1 in the 4:1 or 1:1
sample-to-cellulose sample-to-
ratio (by mass) cellulose ratio (by
tested, exhibits a mass) tested,
mean burning time exhibits a mean
equal to or less burning rate equal
than the mean to or greater than
burning time of a the mean burning
2:3 mixture (by rate of a 1:1
mass) of potassium mixture (by mass)
bromate and of calcium peroxide
cellulose and the and cellulose and
criteria for the criteria for
Category 1 are not Category 1 are not
met. met.
3........................... Any chemical which, Any chemical which,
in the 4:1 or 1:1 in the 4:1 or 1:1
sample-to-cellulose sample-to-
ratio (by mass) cellulose ratio (by
tested, exhibits a mass) tested,
mean burning time exhibits a mean
equal to or less burning rate equal
than the mean to or greater than
burning time of a the mean burning
3:7 mixture (by rate of a 1:2
mass) of potassium mixture (by mass)
bromate and of calcium peroxide
cellulose and the and cellulose and
criteria for the criteria for
Categories 1 and 2 Categories 1 and 2
are not met. are not met.
------------------------------------------------------------------------
Note 1: Some oxidizing solids may present explosion hazards
under certain conditions (e.g., when stored in large quantities).
For example, some types of ammonium nitrate may give rise to an
explosion hazard under extreme conditions and the ``Resistance to
detonation test'' (International Maritime Solid Bulk Cargoes Code,
IMO (IMSBC), Appendix 2, Section 5) may be used to assess this
hazard. When information indicates that an oxidizing solid may
present an explosion hazard, it shall be indicated on the Safety
Data Sheet.
Note 2: Classification of solid chemicals shall be based on
tests performed on the chemical as presented. If, for example, for
the purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.14.3 Additional Classification Considerations
B.14.3.1 For organic chemicals, the classification procedure for
this class shall not be applied if:
(a) The chemical does not contain oxygen, fluorine or chlorine;
or
(b) The chemical contains oxygen, fluorine or chlorine and these
elements are chemically bonded only to carbon or hydrogen.
B.14.3.2 For inorganic chemicals, the classification procedure
for this class shall not be applied if the chemical does not contain
oxygen or halogen atoms.
B.14.3.3 In the event of divergence between test results and
known experience in the handling and use of chemicals which shows
them to be oxidizing, judgements based on known experience shall
take procedure over test results.
B.15 Organic Peroxides
B.15.1 Definition
B.15.1.1 Organic peroxide means a liquid or solid organic
chemical which contains the bivalent -0-0- structure and as such is
considered a derivative of hydrogen peroxide, where one or both of
the hydrogen atoms have been replaced by organic radicals. The term
organic peroxide includes organic peroxide mixtures containing at
least one organic peroxide. Organic peroxides are thermally unstable
chemicals, which may undergo exothermic self-accelerating
decomposition. In addition, they may have one or more of the
following properties:
(a) Be liable to explosive decomposition;
(b) Burn rapidly;
(c) Be sensitive to impact or friction;
(d) React dangerously with other substances.
B.15.1.2 An organic peroxide is regarded as possessing explosive
properties when in laboratory testing the formulation is liable to
detonate, to deflagrate rapidly or to show a violent effect when
heated under confinement.
B.15.2 Classification Criteria
B.15.2.1 Any organic peroxide shall be considered for
classification in this class, unless it contains:
(a) Not more than 1.0% available oxygen from the organic
peroxides when containing not more than 1.0% hydrogen peroxide; or
(b) Not more than 0.5% available oxygen from the organic
peroxides when containing more than 1.0% but not more than 7.0%
hydrogen peroxide.
Note: The available oxygen content (%) of an organic peroxide
mixture is given by the formula:
[GRAPHIC] [TIFF OMITTED] TR20MY24.231
where:
ni = number of peroxygen groups per molecule of organic peroxide i;
ci = concentration (mass %) of organic peroxide i;
mi = molecular mass of organic peroxide i.
B.15.2.2 Organic peroxides shall be classified in one of the
seven categories of ``Types A to G'' for this class, according to
the following principles:
(a) Any organic peroxide which, as packaged, can detonate or
deflagrate rapidly shall be defined as organic peroxide TYPE A;
(b) Any organic peroxide possessing explosive properties and
which, as packaged, neither detonates nor deflagrates rapidly, but
is liable to undergo a thermal explosion in that package shall be
defined as organic peroxide TYPE B;
(c) Any organic peroxide possessing explosive properties when
the chemical as packaged cannot detonate or deflagrate rapidly or
undergo a thermal explosion shall be defined as organic peroxide
TYPE C;
(d) Any organic peroxide which in laboratory testing meets the
criteria in (d)(i), (ii), or (iii) shall be defined as organic
peroxide TYPE D:
(i) Detonates partially, does not deflagrate rapidly and shows
no violent effect when heated under confinement; or
(ii) Does not detonate at all, deflagrates slowly and shows no
violent effect when heated under confinement; or
(iii) Does not detonate or deflagrate at all and shows a medium
effect when heated under confinement;
(e) Any organic peroxide which, in laboratory testing, neither
detonates nor deflagrates at all and shows low or no effect when
heated under confinement shall be defined as organic peroxide TYPE
E;
(f) Any organic peroxide which, in laboratory testing, neither
detonates in the cavitated state nor deflagrates at all and shows
only a low or no effect when heated under confinement as well as low
or no explosive power shall be defined as organic peroxide TYPE F;
(g) Any organic peroxide which, in laboratory testing, neither
detonates in the cavitated state nor deflagrates at all and shows no
effect when heated under
confinement nor any explosive power, provided that it is thermally
stable (self-accelerating decomposition temperature is 60 [deg] C
(140 [deg] F) or higher for a 50 kg (110 lb) package), and, for
liquid mixtures, a diluent having a boiling point of not less than
150 ;[deg] C (302 [deg] F) is used for desensitization, shall be
defined as organic peroxide TYPE G. If the organic peroxide is not
thermally stable or a diluent having a boiling point less than 150
[deg] C (302[deg] F) is used for desensitization, it shall be
defined as organic peroxide TYPE F.
B.15.3 Additional Classification Considerations
B.15.3.1 For purposes of classification, the properties of
organic peroxides shall be determined in accordance with test series
A to H as described in Part II of UN ST/SG/AC.10 (incorporated by
reference, see Sec. 1910.6).
B.15.3.2 Self-accelerating decomposition temperature (SADT)
shall be determined in accordance with UN ST/SG/AC.10 (incorporated
by reference, see Sec. 1910.6), Part II, section 28.
B.15.3.3 Mixtures of organic peroxides may be classified as the
same type of organic peroxide as that of the most dangerous
ingredient. However, as two stable ingredients can form a thermally
less stable mixture, the SADT of the mixture shall be determined.
B.16 Corrosive to Metals
B.16.1 Definition
A chemical which is corrosive to metals means a chemical which
by chemical action will materially damage, or even destroy, metals.
B.16.2 Classification Criteria
A chemical which is corrosive to metals shall be classified in a
single category for this class, using the test in Part III, sub-
section 37.4 of UN ST/SG/AC.10 (incorporated by reference, see Sec.
1910.6), in accordance with Table B.16.1:
Table B.16.1--Criteria for Chemicals Corrosive to Metal
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1...................................... Corrosion rate on either steel
or aluminum surfaces exceeding
6.25 mm per year at a test
temperature of 55 [deg] C (131
[deg] F) when tested on both
materials.
------------------------------------------------------------------------
Note: Where an initial test on either steel or aluminium
indicates the chemical being tested is corrosive the follow-up test
on the other metal is not necessary.
B.16.3 Additional Classification Considerations
The specimen to be used for the test shall be made of the
following materials:
(a) For the purposes of testing steel, steel types S235JR+CR
(1.0037 resp. St 37- 2), S275J2G3+CR (1.0144 resp. St 44-3), ISO
3574, Unified Numbering System (UNS) G 10200, or SAE 1020;
(b) For the purposes of testing aluminium: non-clad types 7075-
T6 or AZ5GU-T6.
B.17 Desensitized Explosives
B.17.1 Definitions and General Considerations
Desensitized explosives are solid or liquid explosive chemicals
which are phlegmatized \10\ to suppress their explosive properties
in such a manner that they do not mass explode and do not burn too
rapidly and therefore may be exempted from the hazard class
``Explosives'' (Chapter B.1; see also Note 2 of paragraph
B.1.3).\11\
---------------------------------------------------------------------------
\10\ Phlegmatized means that a substance (or ``phlegmatizer'')
has been added to an explosive to enhance its safety in handling and
transport. The phlegmatizer renders the explosive insensitive, or
less sensitive, to the following actions: heat, shock, impact,
percussion or friction. Typical phlegmatizing agents include, but
are not limited to: wax, paper, water, polymers (such as
chlorofluoropolymers), alcohol and oils (such as petroleum jelly and
paraffin).
\11\ Unstable explosives as defined in Chapter B.1 can also be
stabilized by desensitization and consequently may be re-classified
as desensitized explosives, provided all criteria of Chapter B.17
are met. In this case, the desensitized explosive should be tested
according to Test Series 3 (Part I of UN ST/SG/AC.10/11/Rev. 6
(incorporated by reference, see Sec. 1910.6)) because information
about its sensitiveness to mechanical stimuli is likely to be
important for determining conditions for safe handling and use. The
results shall be communicated on the safety data sheet.
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B.17.1.1 The class of desensitized explosives comprises:
(a) Solid desensitized explosives: explosive substances or
mixtures which are wetted with water or alcohols or are diluted with
other substances, to form a homogeneous solid mixture to suppress
their explosive properties.
Note: This includes desensitization achieved by formation of
hydrates of the substances.
(b) Liquid desensitized explosives: explosive substances or
mixtures which are dissolved or suspended in water or other liquid
substances, to form a homogeneous liquid mixture to suppress their
explosive properties.
B.17.2 Classification Criteria
B.17.2.1 Any explosive which is desensitized shall be considered
in this class, unless:
(a) It is intended to produce a practical, explosive or
pyrotechnic effect; or
It has a mass explosion hazard according to test series 6 (a) or
6 (b) or its corrected burning rate according to the burning rate
test described in part V, subsection 51.4 of UN ST/SG/AC.10/11/Rev.6
(incorporated by reference, see Sec. 1910.6) is greater than 1200
kg/min; or
(b) Its exothermic decomposition energy is less than 300 J/g.
Note 1: Substances or mixtures which meet the criterion (a) or
(b) shall be classified as explosives (see Chapter B.1). Substances
or mixtures which meet the criterion (c) may fall within the scope
of other physical hazard classes.
Note 2: The exothermic decomposition energy may be estimated
using a suitable calorimetric technique (see section 20, sub-section
20.3.3.3 in Part II of UN ST/SG/AC.10/11/Rev.6 (incorporated by
reference, see Sec. 1910.6).
B.17.2.2 Desensitized explosives shall be classified in one of
the four categories of this class depending on the corrected burning
rate (Ac) using the test ``burning rate test (external fire)''
described in Part V, sub-section 51.4 of UN ST/SG/AC.10/11/Rev.6
(incorporated by reference, see Sec. 1910.6), according to Table
B.17.1:
Table B.17.1--Criteria for Desensitized Explosives
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1.................................. Desensitized explosives with a
corrected burning rate (AC) equal
to or greater than 300 kg/min but
not more than 1200 kg/min.
2.................................. Desensitized explosives with a
corrected burning rate (AC) equal
to or greater than 140 kg/min but
less than 300 kg/min.
3.................................. Desensitized explosives with a
corrected burning rate (AC) equal
to or greater than 60 kg/min but
less than 140 kg/min.
4.................................. Desensitized explosives with a
corrected burning rate (AC) less
than 60 kg/min.
------------------------------------------------------------------------
Note 1: Desensitized explosives shall be prepared so that they
remain homogeneous and do not separate during normal storage and
handling, particularly if desensitized by wetting. The manufacturer,
importer, or distributor shall provide information in Section 10 of
the safety data sheet about the shelf-life and instructions on
verifying desensitization. Under certain conditions the content of
desensitizing agent (e.g., phlegmatizer, wetting agent or treatment)
may decrease during supply and use, and thus, the hazard potential
of the desensitized explosive may increase. In addition, Sections 5
and/or 8 of the safety data sheet shall include advice on avoiding
increased fire, blast or protection hazards when the chemical is not
sufficiently desensitized.
Note 2: Explosive properties of desensitized explosives shall
be determined using data from Test Series 2 of UN ST/SG/
AC.10/11/Rev.6 (incorporated by reference, see Sec. 1910.6) and
shall be communicated in the safety data sheet. For testing of
liquid desensitized explosives, refer to section 32, sub-section
32.3.2 of UN ST/SG/AC.10/11/Rev.6 (incorporated by reference, see
1910.6). Testing of solid desensitized explosives is addressed in
section 33, sub-section 33.2.3 of UN ST/SG/AC.10/11/Rev.6
(incorporated by reference, see Sec. 1910.6).
Note 3: Desensitized explosives do not fall additionally within
the scope of chapters B.1 (explosives), B.6 (flammable liquids) and
B.7 (flammable solids).
B.17.3 Additional Classification Considerations
B.17.3.1 The classification procedure for desensitized
explosives does not apply if:
(a) The substances or mixtures contain no explosives according
to the criteria in Chapter B.1; or
(b) The exothermic decomposition energy is less than 300 J/g.
B.17.3.2 The exothermic decomposition energy shall be determined
using the explosive already desensitized (i.e., the homogenous solid
or liquids mixture formed by the explosive and the substance(s) used
to suppress its explosive properties). The exothermic decomposition
energy may be estimated using a suitable calorimetric technique (see
Section 20, sub-section 20.3.3.3 in Part II of UN ST/SG/AC.10/11/
Rev. 6 (incorporated by reference, see Sec. 1910.6).
Appendix C to Sec. 1910.1200--Allocation of Label Elements
(Mandatory)
C.1 The label for each hazardous chemical shall include the
product identifier used on the safety data sheet.
C.1.1 The labels on shipped containers shall also include the
name, address, and telephone number of the chemical manufacturer,
importer, or responsible party.
C.2 The label for each hazardous chemical that is classified
shall include the signal word, hazard statement(s), pictogram(s),
and precautionary statement(s) specified in C.4 for each hazard
class and associated hazard category, except as provided for in
C.2.1 through C.2.4.
C.2.1 Precedence of Hazard Information
C.2.1.1 If the signal word ``Danger'' is included, the signal
word ``Warning'' shall not appear;
C.2.1.2 If the skull and crossbones pictogram is included, the
exclamation mark pictogram shall not appear where it is used for
acute toxicity;
C.2.1.3 If the corrosive pictogram is included, the exclamation
mark pictogram shall not appear where it is used for skin or eye
irritation;
C.2.1.4 If the health hazard pictogram is included for
respiratory sensitization, the exclamation mark pictogram shall not
appear where it is used for skin sensitization or for skin or eye
irritation.
C.2.2 Hazard Statement Text
C.2.2.1 The text of all applicable hazard statements shall
appear on the label, except as otherwise specified. The information
in italics shall be included as part of the hazard statement as
provided. For example: ``causes damage to organs (state all organs
affected) through prolonged or repeated exposure (state route of
exposure if no other routes of exposure cause the hazard)''. Hazard
statements may be combined where appropriate to reduce the
information on the label and improve readability, as long as all of
the hazards are conveyed as required.
C.2.2.2 If the chemical manufacturer, importer, or responsible
party can demonstrate that all or part of the hazard statement is
inappropriate to a specific substance or mixture, the corresponding
statement may be omitted from the label.
C.2.3 Pictograms
C.2.3.1 Pictograms shall be in the shape of a square set at a
point and shall include a black hazard symbol on a white background
with a red frame sufficiently wide to be clearly visible. A square
red frame set at a point without a hazard symbol is not a pictogram
and is not permitted on the label.
C.2.3.2 One of eight standard hazard symbols shall be used in
each pictogram. The eight hazard symbols are depicted in Figure C.1.
A pictogram using the exclamation mark symbol is presented in Figure
C.2, for the purpose of illustration.
Figure C.1--Hazard Symbols and Classes
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Figure C.2--Exclamation Mark Pictogram
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C.2.3.3 The exclamation mark pictogram is permitted (but not
required) for HNOCs as long as the words ``Hazard Not Otherwise
Classified'' or the letters ``HNOC'' appear below the pictogram.
C.2.3.4 Pictograms may only appear once on a label. If multiple
hazards require the use of the same pictogram, it may not appear a
second time on the label.
C.2.4 Precautionary Statement Text
C.2.4.1 There are four types of precautionary statements
presented, ``prevention,'' ``response,'' ``storage,'' and
``disposal.'' The core part of the precautionary statement is
presented in bold print. This is the text, except as otherwise
specified, that shall appear on the label. Where additional
information is required, it is indicated in plain text.
C.2.4.2 When a backslash or diagonal mark (/) appears in the
precautionary statement text, it indicates that a choice has to be
made between the separated phrases. In such cases, the chemical
manufacturer, importer, or responsible party can choose the most
appropriate phrase(s). For example, ``Wear protective gloves/
protective clothing/eye protection/face protection'' could read
``wear eye protection''.
C.2.4.3 When three full stops (. . .) appear in the
precautionary statement text, they indicate that all applicable
conditions are not listed. For example, in ``Use explosion-proof
electrical/ventilating/lighting/. . ./equipment'', the use of ``. .
.'' indicates that other equipment may need to be specified. In such
cases, the chemical manufacturer, importer, or responsible party can
choose the other conditions to be specified.
C.2.4.4 When text in italics is used in a precautionary
statement, this indicates specific conditions applying to the use or
allocation of the precautionary statement. For example, ``Use
explosion-proof electrical/ventilating/lighting/. . ./equipment'' is
only required for flammable solids ``if dust clouds can occur''.
Text in italics is intended to be an explanatory, conditional note
and is not intended to appear on the label.
C.2.4.5 Where square brackets ([ ]) appear around text in a
precautionary statement, this indicates that the text in square
brackets is not appropriate in every case and should be used only in
certain circumstances. In these cases, conditions for use explaining
when the text should be used are provided. For example, one
precautionary statement states: ``[In case of inadequate
ventilation] wear respiratory protection.'' This statement is given
with the condition for use ``- text in square brackets may be used
if additional information is provided with the chemical at the point
of use that explains what type of ventilation would be adequate for
safe use''. This means that, if additional information is provided
with the chemical explaining what type of ventilation would be
adequate for safe use, the text in square brackets should be used
and the statement would read: ``In case of inadequate ventilation
wear respiratory protection.'' However, if the chemical is supplied
without such ventilation information, the text in square brackets
should not be used, and the precautionary statement should read:
``Wear respiratory protection.''
C.2.4.6 Precautionary statements may be combined or consolidated
to save label space and improve readability. For example, ``Keep
away from heat, sparks and open flame,'' ``Store in a well-
ventilated place'' and ``Keep cool'' can be combined to read ``Keep
away from heat, sparks and open flame and store in a cool, well-
ventilated place.''
C.2.4.7 Precautionary statements may incorporate minor textual
variations from the text prescribed in this Appendix if these
variations assist in communicating safety information (e.g.,
spelling variations, synonyms or other equivalent terms) and the
safety advice is not diluted or compromised. Any variations must be
used consistently on the label and the safety data sheet.
C.2.4.8 In most cases, the precautionary statements are
independent (e.g., the phrases for explosives hazards do not modify
those related to certain health hazards, and products that are
classified for both hazard classes shall bear appropriate
precautionary statements for both). Where a chemical is classified
for a number of hazards, and the precautionary statements are
similar, the most stringent shall be included on the label (this
will be applicable mainly to preventive measures).
C.2.4.9 If the chemical manufacturer, importer, or responsible
party can demonstrate that a precautionary statement is
inappropriate to a specific substance or mixture, the precautionary
statement may be omitted from the label.
C.2.4.10 Where a substance or mixture is classified for a number
of health hazards, this may trigger multiple precautionary
statements relating to medical response, e.g., calling a poison
center/doctor/. . . and getting medical advice/attention.
In general, the following principles should be applied:
(a) Where the classification of a substance or mixture triggers
several different precautionary statements, a system of
prioritization should be applied. If the same medical response
statement is triggered multiple times, the label need only include
one precautionary statement reflecting the response at the highest
level with the greatest urgency, which should always be combined
with at least one route of exposure or symptom ``IF'' statement.
(b) Routes of exposure, including ``IF exposed or concerned,''
may be combined when triggered with a medical response statement. If
the response statement is triggered with three or more routes of
exposure, ``IF exposed or concerned'' may be used. However, relevant
``IF'' statements describing symptoms must be included in full. If a
route of exposure is triggered multiple times, it need only be
included once.
(c) This does not apply to ``Get medical advice/attention if you
feel unwell'' or ``Get immediate medical advice/attention'' when
they are combined with an ``If'' statement and must appear without
prioritization.
C.3 Supplementary Hazard Information
C.3.1 To ensure that non-standardized information does not lead
to unnecessarily wide variation or undermine the required
information, supplementary information on the label is limited to
when it provides further detail and does not contradict or cast
doubt on the validity of the standardized hazard information.
C.3.2 Where the chemical manufacturer, importer, or distributor
chooses to add supplementary information on the label, the placement
of supplemental information shall not impede identification of
information required by this section.
C.3.3 Where an ingredient with unknown acute toxicity is used in
a mixture at a concentration >=1%, and the mixture is not classified
based on testing of the mixture as a whole, a statement that X% of
the mixture consists of ingredient(s) of unknown acute toxicity
(oral/dermal/inhalation) is required on the label and safety data
sheet.
C.4 Requirements for Signal Words, Hazard Statements, Pictograms, and
Precautionary Statements
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Appendix D to Sec. 1910.1200--Safety Data Sheets (Mandatory)
A safety data sheet (SDS) shall include the information
specified in Table D.1 under the section number and heading
indicated for sections 1-11 and 16. While each section of the SDS
must contain all of the specified information, preparers of safety
data sheets are not required to present the information in any
particular order within each section. If no relevant information is
found for any given subheading within a section, the SDS shall
clearly indicate that no applicable information is available.
Sections 12-15 may be included in the SDS, but are not mandatory.
Table D.1--Minimum Information for an SDS
----------------------------------------------------------------------------------------------------------------
Headings Subheadings
----------------------------------------------------------------------------------------------------------------
1. Identification........................... (a) Product identifier used on the label;
(b) Other means of identification;
(c) Recommended use of the chemical and restrictions on use;
(d) Name, U.S. address, and U.S. telephone number of the chemical
manufacturer, importer, or other responsible party;
(e) Emergency phone number.
2. Hazard Identification.................... (a) Classification of the chemical in accordance with paragraph
(d)(1)(i) of Sec. 1910.1200;
(b) Signal word, hazard statement(s), symbol(s) and precautionary
statement(s) in accordance with paragraph (f) of Sec.
1910.1200. (Hazard symbols may be provided as graphical
reproductions in black and white or the name of the symbol, e.g.,
flame, skull and crossbones);
(c) Hazards classified under paragraph (d)(1)(ii) of Sec.
1910.12000;
(d) Describe any hazards not otherwise classified that have been
identified during the classification process;
(e) Where an ingredient with unknown acute toxicity is used in a
mixture at a concentration >=1% and the mixture is not classified
based on testing of the mixture as a whole, a statement that X%
of the mixture consists of ingredient(s) of unknown acute
toxicity is required.
3. Composition/information on ingredients... Except as provided for in paragraph (i) of Sec. 1910.1200 on
trade secrets:
For Substances
(a) Chemical name;
(b) Common name and synonyms;
(c) CAS number and other unique identifiers;
(d) Impurities and stabilizing additives (constituents) which are
themselves classified and which contribute to the classification
of the substance.
For Mixtures
In addition to the information required for substances:
(a) The chemical name, CAS number or other unique identifier, and
concentration (exact percentage) or concentration ranges of all
ingredients which are classified as health hazards in accordance
with paragraph (d) of Sec. 1910.1200 and
(1) are present above their cut-off/concentration limits; or
(2) present a health risk below the cut-off/concentration
limits.
Note: When CAS number is not available or claimed as a trade
secret, the preparer must indicate the source of unique
identifier.
(b) The concentration (exact percentage) shall be specified unless
a trade secret claim is made in accordance with paragraph (i) of
Sec. 1910.1200, when there is batch-to-batch variability in the
production of a mixture, or for a group of substantially similar
mixtures (See A.0.5.1.2) with similar chemical composition. In
these cases, concentration ranges may be used.
For All Chemicals Where a Trade Secret is Claimed
Where a trade secret is claimed in accordance with paragraph (i)
of Sec. 1910.1200, a statement that the specific chemical
identity, and/or concentration (exact or range) of the
composition has been withheld as a trade secret is required. When
the concentration or concentration range is withheld as a trade
secret, the prescribed concentration ranges used in Sec.
1910.1200(i)(1)(iv)-(vi) must be used.
4. First aid measures....................... (a) Description of necessary measures, subdivided according to the
different routes of exposure, i.e., inhalation, skin and eye
contact, and ingestion;
(b) Most important symptoms/effects, acute and delayed.
(c) Indication of immediate medical attention and special
treatment needed, if necessary.
5. Fire-fighting measures................... (a) Suitable (and unsuitable) extinguishing media.
(b) Specific hazards arising from the chemical (e.g., nature of
any hazardous combustion products).
(c) Special protective equipment and precautions for fire-
fighters.
6. Accidental release measures.............. (a) Personal precautions, protective equipment, and emergency
procedures.
(b) Methods and materials for containment and cleaning up.
7. Handling and storage..................... (a) Precautions for safe handling.
(b) Conditions for safe storage, including any incompatibilities.
8. Exposure controls/personal protection.... (a) For all ingredients or constituents listed in Section 3, the
OSHA permissible exposure limit (PEL), American Conference of
Governmental Industrial Hygienists (ACGIH) Threshold Limit Value
(TLV), and any other exposure limit or range used or recommended
by the chemical manufacturer, importer, or employer preparing the
safety data sheet, where available.
(b) Appropriate engineering controls.
(c) Individual protection measures, such as personal protective
equipment.
9. Physical and chemical properties [dagger] (a) Physical state.
(b) Color.
(c) Odor (includes odor threshold).
(d) Melting point/freezing point.
(e) Boiling point (or initial boiling point or boiling range).
(f) Flammability.
(g) Lower and upper explosion limit/flammability limit.
(h) Flash point.
(i) Auto-ignition temperature.
(j) Decomposition temperature.
(k) pH.
(l) Kinematic viscosity.
(m) Solubility.
(n) Partition coefficient n-octanol/water (log value).
(o) Vapor pressure (includes evaporation rate).
(p) Density and/or relative density.
(q) Relative vapor density.
(r) Particle characteristics.
10. Stability and reactivity................
(a) Reactivity;
(b) Chemical stability;
(c) Possibility of hazardous reactions, including those associated
with foreseeable emergencies;
(d) Conditions to avoid (e.g., static discharge, shock, or
vibration);
(e) Incompatible materials;
(f) Hazardous decomposition products.
11. Toxicological information............... Description of the various toxicological (health) effects and the
available data used to identify those effects, including:
(a) Information on the likely routes of exposure (inhalation,
ingestion, skin, and eye contact);
(b) Symptoms related to the physical, chemical, and toxicological
characteristics;
(c) Delayed and immediate effects and also chronic effects from
short- and long-term exposure;
(d) Numerical measures of toxicity (such as acute toxicity
estimates);
(e) Interactive effects; information on interactions should be
included if relevant and readily available;
(f) Whether the hazardous chemical is listed in the National
Toxicology Program (NTP) Report on Carcinogens (latest edition)
or has been found to be a potential carcinogen in the
International Agency for Research on Cancer (IARC) Monographs
(latest edition), or by OSHA.
(g) When specific chemical data or information is not available,
the preparer must indicate if alternative information is used and
the method used to derive the information (e.g., where the
preparer is using information from a class of chemicals rather
than the exact chemical in question and using SAR to derive the
toxicological information).
12. Ecological information (Non-mandatory).. (a) Ecotoxicity (aquatic and terrestrial, where available);
(b) Persistence and degradability;
(c) Bioaccumulative potential;
(d) Mobility in soil;
(e) Other adverse effects (such as hazardous to the ozone layer).
13. Disposal considerations (Non-mandatory). Description of waste residues and information on their safe
handling and methods of disposal, including the disposal of any
contaminated packaging.
14. Transport information (Non-mandatory)... (a) UN number;
(b) UN proper shipping name;
(c) Transport hazard class(es);
(d) Packing group, if applicable;
(e) Environmental hazards (e.g., Marine pollutant (Yes/No));
(f) Transport in bulk (according to IMO instruments
(g) Special precautions which a user needs to be aware of, or
needs to comply with, in connection with transport or conveyance
either within or outside their premises
15. Regulatory information (Non-mandatory).. Safety, health and environmental regulations specific for the
product in question.
16. Other information, including date of The date of preparation of the SDS or the last change to it.
preparation or last revision.
----------------------------------------------------------------------------------------------------------------
[dagger] Note: To determine the appropriate flammable liquid storage container size and type, the boiling point
shall be determined by methods specified under Sec. 1910.106(a)(5) and then listed on the SDS. In addition,
the manufacturer, importer, and distributor shall clearly note in sections 7 and 9 of the SDS if an alternate
calculation was used for storage purposes and the classification for storage differs from the classification
listed in section 2 of the SDS.
[FR Doc. 2024-08568 Filed 5-17-24; 8:45 am]
BILLING CODE 4510-26-P
