[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]



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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: 
[email protected].
    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: 
[email protected].

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

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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/
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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

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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

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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).
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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).

[[Page 44151]]

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.

[[Page 44152]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 44153]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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).
---------------------------------------------------------------------------

    \6\ https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=1218-AC93.
---------------------------------------------------------------------------

    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

[[Page 44154]]

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.

[[Page 44155]]

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

[[Page 44156]]

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

[[Page 44170]]

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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BILLING CODE 4510-26-C
    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

[[Page 44172]]

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

[[Page 44175]]

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

[[Page 44176]]

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--

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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

[[Page 44196]]

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).
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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

[[Page 44197]]

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.

[[Page 44198]]

    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

[[Page 44204]]

(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

[[Page 44205]]

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-

[[Page 44206]]

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.

[[Page 44207]]

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.
BILLING CODE 4510-26-P

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[[Page 44211]]


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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 44212]]

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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BILLING CODE 4510-26-C

[[Page 44222]]

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.
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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

[[Page 44223]]

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.
BILLING CODE 4510-26-P
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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

[[Page 44224]]

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.
---------------------------------------------------------------------------

    \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

[[Page 44225]]

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).
[GRAPHIC] [TIFF OMITTED] TR20MY24.187

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,

[[Page 44226]]

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

[[Page 44227]]

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\
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \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.

[[Page 44228]]

[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

[[Page 44229]]

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\
---------------------------------------------------------------------------

    \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.

[[Page 44230]]

[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

[[Page 44231]]

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).
BILLING CODE 4510-26-P

[[Page 44232]]

[GRAPHIC] [TIFF OMITTED] TR20MY24.191

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.
---------------------------------------------------------------------------

    \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).
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    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

[[Page 44233]]

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).
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    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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    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.

[[Page 44242]]

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\
---------------------------------------------------------------------------

    \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

[[Page 44260]]

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

[[Page 44261]]

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:

[[Page 44262]]

    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

[[Page 44267]]

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

[[Page 44268]]

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

[[Page 44269]]

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

[[Page 44270]]

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

[[Page 44271]]

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.

[[Page 44272]]

    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

[[Page 44273]]

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

[[Page 44274]]

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,

[[Page 44275]]

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.

[[Page 44276]]

    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

[[Page 44277]]

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

[[Page 44278]]

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.
---------------------------------------------------------------------------

    \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

[[Page 44279]]

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

[[Page 44280]]

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

[[Page 44281]]

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

[[Page 44282]]

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

[[Page 44283]]

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

[[Page 44284]]

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

[[Page 44285]]

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

[[Page 44286]]

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

[[Page 44287]]

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

[[Page 44288]]

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

[[Page 44289]]

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

[[Page 44290]]

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

[[Page 44291]]

(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.

[[Page 44292]]

    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

[[Page 44293]]

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

[[Page 44294]]

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

[[Page 44295]]

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).

[[Page 44296]]

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

[[Page 44297]]

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

[[Page 44298]]

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.
---------------------------------------------------------------------------

    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

[[Page 44299]]

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

[[Page 44300]]

``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

[[Page 44301]]

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

[[Page 44302]]

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

[[Page 44303]]

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

[[Page 44304]]

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,

[[Page 44305]]

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.

[[Page 44306]]

    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.,

[[Page 44307]]

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).

[[Page 44308]]

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

[[Page 44309]]

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

[[Page 44310]]

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

[[Page 44311]]

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

[[Page 44312]]

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

[[Page 44313]]

``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

[[Page 44314]]

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

[[Page 44315]]

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

[[Page 44316]]

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

[[Page 44317]]

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

[[Page 44318]]

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

[[Page 44319]]

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

[[Page 44320]]

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

[[Page 44321]]

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

[[Page 44322]]

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.

[[Page 44323]]

    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

[[Page 44324]]

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

[[Page 44325]]

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.
---------------------------------------------------------------------------

    \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

[[Page 44326]]

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

[[Page 44327]]

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

[[Page 44328]]

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

[[Page 44329]]

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.

[[Page 44330]]

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

[[Page 44331]]

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

[[Page 44332]]

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,

[[Page 44333]]

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,

[[Page 44334]]

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

[[Page 44335]]

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

[[Page 44336]]

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

[[Page 44337]]

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

[[Page 44338]]

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

[[Page 44339]]

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

[[Page 44340]]

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

[[Page 44341]]

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

[[Page 44342]]

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.

[[Page 44343]]

    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

[[Page 44344]]

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,

[[Page 44345]]

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

[[Page 44346]]

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

[[Page 44347]]

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

[[Page 44348]]

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''

[[Page 44349]]

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).

[[Page 44350]]

    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

[[Page 44351]]

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

[[Page 44352]]

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-

[[Page 44353]]

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).

[[Page 44354]]

    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:

[[Page 44355]]



------------------------------------------------------------------------
               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 [email protected].
    (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: [email protected]; 
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: [email protected]; 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: 
[email protected]; 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: [email protected]; 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: [email protected]; 
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: [email protected]; 
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

[[Page 44356]]

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

[[Page 44357]]

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

[[Page 44358]]

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

[[Page 44359]]

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,

[[Page 44360]]

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.

[[Page 44361]]

    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.

[[Page 44362]]



       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

[[Page 44363]]

[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

[[Page 44364]]

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

[[Page 44365]]

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

[[Page 44366]]

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.:


[[Page 44367]]


--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%.


[[Page 44368]]


 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.

[[Page 44369]]

 
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


[[Page 44370]]


[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

[[Page 44371]]

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.

[[Page 44372]]



                   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.
----------------------------------------------------------------------------------------------------------------


[[Page 44373]]

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

[[Page 44374]]

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:

[[Page 44375]]

    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.

[[Page 44376]]

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%  .................

[[Page 44377]]

 
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.

[[Page 44378]]

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

[[Page 44379]]

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.

[[Page 44380]]



     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

[[Page 44381]]

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.

[[Page 44382]]

    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,

[[Page 44383]]

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.

[[Page 44384]]

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.

[[Page 44385]]

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

[[Page 44386]]

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

[[Page 44387]]

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

[[Page 44388]]

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

[[Page 44389]]

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-

[[Page 44390]]

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

[[Page 44391]]

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;

[[Page 44392]]

    (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:

[[Page 44393]]



               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

[[Page 44394]]

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.
---------------------------------------------------------------------------

    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/

[[Page 44395]]

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
[GRAPHIC] [TIFF OMITTED] TR20MY24.232


[[Page 44396]]



Figure C.2--Exclamation Mark Pictogram
[GRAPHIC] [TIFF OMITTED] TR20MY24.233

    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.

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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;

[[Page 44460]]

 
                                              (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;

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                                              (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