Document ID: OSHA-2019-0001-0258
Agency: osha
Document Type: Proposed Rule
Title: Hazard Communication Standard
Posted Date: 2021-02-16T05:00Z

[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Proposed Rules]
[Pages 9576-9831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28987]

[[Page 9575]]

Vol. 86

Tuesday,

No. 29

February 16, 2021

Part II

Department of Labor

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 Occupational Safety and Health Administration

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29 CFR Part 1910

 Hazard Communication Standard; Proposed Rule

  Federal Register / Vol. 86 , No. 29 / Tuesday, February 16, 2021 / 
Proposed Rules  

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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: Proposed rule; request for comments.

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SUMMARY: OSHA is proposing through this notice of proposed rulemaking 
(NPRM) to modify the Hazard Communication Standard (HCS) to conform to 
the United Nations' Globally Harmonized System of Classification and 
Labelling of Chemicals (GHS) Revision 7 (GHS, Rev. 7), to 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, without lowering overall protections of 
the standard. OSHA has preliminarily determined that the proposed 
revisions to the HCS will reduce costs and burdens while also improving 
the quality and consistency of information provided to employers and 
employees regarding chemical hazards and associated protective 
measures. Consistent with the Executive order entitled ``Improving 
Regulation and Regulatory Review'' (January 18, 2011) and section 3(a) 
of the Regulatory Flexibility Act, which call for assessment and, where 
appropriate, modification and improvement of existing rules to minimize 
any significant economic impact upon a substantial number of small 
entities, OSHA has reviewed the existing HCS. The agency has 
preliminarily determined that the proposed revisions 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 proposed 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, technical amendments related to the contents of 
safety data sheets (SDSs), and related revisions to definitions of 
terms used in the standard.

DATES: Comments on this NPRM (including requests for hearing) and other 
information must be submitted by April 19, 2021.
    Informal public hearing: OSHA will schedule an informal public 
hearing on the proposed rule if requested during the comment period. If 
a hearing is requested, the location and date of the hearing, 
procedures for interested parties to notify the agency of their 
intention to participate, and procedures for participants to submit 
their testimony and documentary evidence will be announced in the 
Federal Register.

ADDRESSES: 
    Written comments: You may submit comments and attachments, 
identified by Docket No. OSHA-2019-0001, electronically at http://www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow 
the instructions online for making electronic submissions. After 
accessing ``all documents and comments'' in the docket (Docket No. 
OSHA-2019-0001), check the ``proposed rule'' box in the column headed 
``Document Type,'' find the document posted on the date of publication 
of this document, and click the ``Comment Now'' link. When uploading 
multiple attachments to regulations.gov, please number all of your 
attachments because www.regulations.gov will not automatically number 
the attachments. This will be very useful in identifying all 
attachments in the preamble. For example, Attachment 1_title of your 
document, Attachment 2_title of your document, Attachment 3_title of 
your document. For assistance with commenting and uploading documents, 
please see the Frequently Asked Questions on regulations.gov.
    Instructions: All submissions must include the agency's name and 
the docket number for this rulemaking (Docket No. OSHA-2019-0001). All 
comments, including any personal information you provide, are placed in 
the public docket without change and may be made available online at 
http://www.regulations.gov. Therefore, OSHA cautions commenters about 
submitting information they do not want made available to the public, 
or submitting materials that contain personal information (either about 
themselves or others), such as Social Security Numbers and birthdates.
    Docket: To read or download comments and materials submitted in 
response to this Federal Register document, go to Docket No. OSHA-2019-
0001 at http://www.regulations.gov. All comments and submissions are 
listed in the http://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.\1\
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    \1\ Documents submitted to the docket by OSHA or stakeholders 
are assigned document identification numbers (Document ID) for easy 
identification and retrieval. The full Document ID is the docket 
number plus a unique four-digit code. OSHA is identifying supporting 
information in this NPRM by author name, publication year, and the 
last four digits of the Document ID.

FOR FURTHER INFORMATION CONTACT: 
    For press inquiries: Contact Frank Meilinger, Director, Office of 
Communications, Occupational Safety and Health Administration, U.S. 
Department of Labor; telephone: (202) 693-1999; email: 
meilinger.francis2@dol.gov.
    For general information and technical inquiries: Contact Maureen 
Ruskin, Acting Director, Directorate of Standards and Guidance, 
Occupational Safety and Health Administration, U.S. Department of 
Labor; telephone (202) 693-1950 or fax (202) 693-1678; email: 
ruskin.maureen@dol.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
II. Introduction
III. Events Leading to the Proposed Modifications to the Hazard 
Communication Standard
IV. Need and Support for the Proposed Modifications to the Hazard 
Communication Standard
V. Pertinent Legal Authority
VI. OMB Review Under the Paperwork Reduction Act of 1995
VII. Preliminary Economic Analysis and Initial Regulatory 
Flexibility Analysis
VIII. Federalism
IX. State-Plan States
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. Issues and Options Considered
XV. Summary and Explanation of the Proposed Modifications to the 
Hazard Communication Standard
XVI. Authority and Signature

I. Executive Summary

    The Globally Harmonized System of Classification and Labeling of 
Chemicals (GHS) has been implemented around the world. In 2012, OSHA 
updated its Hazard Communication Standard (HCS), 29 CFR 1910.1200, to 
align with Revision 3 of the GHS (77 FR 17574).

[[Page 9577]]

However, the GHS is updated with improvements and clarifications every 
two years. This proposed rulemaking would amend the HCS to align with 
Revision 7 of the GHS, published in 2017. OSHA is also proposing 
updates to address specific issues that have arisen since the 2012 
rulemaking and to provide better alignment with international trading 
partners, without lowering the protections provided by 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. 610, which requires periodic 
review 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) to assure, as far as possible, safe and healthful working 
conditions for the Nation's working men and women. As part of this 
effort, OSHA first promulgated the HCS in 1983 to provide a 
standardized approach to workplace hazard communications associated 
with exposure to hazardous chemicals. The HCS requires chemical 
manufacturers or importers to classify the hazards of chemicals they 
produce or import. The standard 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. OSHA is not proposing to change the fundamental structure 
of the HCS.
    OSHA has preliminarily determined that the proposed amendments to 
the HCS would enhance the effectiveness of the standard by ensuring 
that employees are appropriately apprised of the chemical hazards to 
which they may be exposed. The proposed 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 proposed 
provisions addressing the labeling of small containers and the 
relabeling of chemicals that have been released for shipment), 
technical 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 all applicable Executive Orders, 
the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act, 
OSHA has prepared a Preliminary Economic Analysis (PEA), including a 
Preliminary Regulatory Flexibility Analysis Certification, for the 
proposed modifications to the HCS (see the full PEA in Section VII of 
this document). Supporting materials prepared by OSHA, such as 
spreadsheets, are available in the public docket for this rulemaking, 
Docket ID OSHA-2019-0001, through www.regulations.gov. OSHA invites 
comments on all aspects of the PEA.
    In the PEA, OSHA estimates that the proposed rule would result in 
net cost savings of $26.8 million per year at a 7 percent discount 
rate, 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 proposed rule would result in net cost savings of 
$27.5 million per year. Under a perpetual time horizon to allow for 
cost comparisons under Executive Order 13771, OSHA estimates that the 
net cost savings of the proposed rule at a discount rate of 7 percent 
would be $19.6 million per year in 2016 dollars.\2\ OSHA also expects 
that the proposed revisions to the HCS would 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 VII.D. 
Health and Safety Benefits and Unquantified Positive Economic Effects).
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    \2\ This calculation (a) converts the costs and cost savings of 
the rule from 2019 dollars to 2016 dollars using the BEA (2020) 
implicit price deflator for Gross Domestic Product, and (b) 
discounts the first year costs by five years, to reflect the five 
years between 2016 and 2021, the scheduled year of publication of 
this NPRM. For further details, see Document ID 0049, tab 
``Tables'', E.O. 13771 Summary Table.
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BILLING CODE 4510-26-P

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[GRAPHIC] [TIFF OMITTED] TP16FE21.000

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BILLING CODE 4510-26-C

II. Introduction

    This preamble to the proposal to modify the HCS includes a review 
of the events leading to the proposal, a discussion of the reasons why 
OSHA believes these modifications are necessary, the preliminary 
economic and regulatory flexibility analysis for the proposal, and an 
explanation of the specific revisions OSHA is proposing to make to the 
standard.

III. Events Leading to the Proposed Modifications to the 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 United 
Nations' Globally Harmonized System of Classification and Labelling of 
Chemicals (GHS) (UN GHS, Rev. 3, 2009, Document ID 0085) (77 FR 17574).
    OSHA has always envisioned that the HCS would require periodic 
rulemakings 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 (77 FR 17574). This section 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 proposed 
rule.
    Several international and domestic activities have impacted the 
direction of the HCS and led to the updates proposed in this NPRM, 
including negotiations at the UN, OSHA's participation in the U.S.-
Canada Regulatory Cooperation Council (RCC) with Health Canada, and 
information OSHA has received from HCS stakeholders. These are 
discussed below.

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 United Nations Economic 
and Social Council Committee of Experts on the Transport of Dangerous 
Goods (TDG) and continued in the 1990s through the United Nations 
Conference on Environment and Economic Development (UNCED), the United 
Nations International Labour Organization (ILO), and the Organization 
for Economic Cooperation and Development (OECD) (UN GHS, 2019, 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 (UN 
GHS, 2020, Document ID 0052). OSHA largely adopted the third revision 
to the GHS in 2012.
    OSHA leads the U.S. Interagency GHS Coordinating Group, an 
interagency group that serves as a U.S. delegation to the UN. 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 United Nations Sub-Committee of Experts on the GHS (UNSCEGHS). The 
Interagency Group 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), and the Bureau of Alcohol, Tobacco, 
Firearms and Explosives (ATF). 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) (CPSC, 2006, Document ID 
0175). The EPA (which initiated the U.S. working group) has proposed 
changes to its regulations governing significant new uses of chemical 
substances under the Toxic Substances Control Act that would align with 
the HCS and the GHS as well as OSHA's respiratory protection standard 
(29 CFR 1910.134) and National Institute for Occupational Safety and 
Health (NIOSH) respirator certification requirements (81 FR 49598).
    Since OSHA's adoption of Revision 3 in 2012, the GHS has been 
updated five times; the latest revision, Revision 8, was published in 
July 2019 (UN GHS, Rev. 8, 2019, Document ID 0065). Updates to the GHS 
in Revision 4 (2011) included changes to hazard categories for 
chemically unstable gases and non-flammable aerosols and updates to, 
and clarification of, precautionary statements (UN GHS, 2011, Document 
ID 0240). Changes in Revision 5 of the GHS (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 (UN GHS, 2013, Document ID 0241).
    Revision 6 of the GHS (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 (UN GHS, 2015, Document ID 
0134). Changes in Revision 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 labelling of small packages

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with fold-out labels (UN GHS, 2017, Document ID 0094). Revision 8 
(published July 2019) includes a change in classification criteria for 
aerosols (based on flammable properties, heat of combustion); 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'' (UN GHS, Rev. 8, 2019, Document ID 
0065). OSHA is proposing to revise the HCS to align with the GHS 
Revision 7; however, the agency has included select provisions from 
Revision 8 for consideration in this rulemaking. Major U.S. trading 
partners are also aligning with Revision 7. This is discussed in more 
detail in the introduction to Issues and Options (see Section XIV) and 
the introduction to Summary and Explanation (see Section XV).
    The GHS model is comprehensive and forward-looking, embracing 
concepts defined in the principles of aggregate exposure and cumulative 
risk, which have been developed and/or adopted by agencies such as the 
U.S. EPA pesticides program and NIOSH (US EPA, 2017, Document ID 0054; 
Lentz, 2015, Document ID 0071). In brief, aggregate exposure considers 
the combined exposures of a single chemical from multiple pathways 
(e.g., oral, dermal, inhalation), while cumulative risk evaluates the 
potential adverse effects from multiple chemicals or stressors (such as 
heat and noise). Because of its comprehensive approach, the GHS takes 
into consideration multiple aspects of the intrinsic hazards of a 
chemical (e.g., physical, health, and environmental hazards) and makes 
this information available in a manner that facilitates the assessment 
of aggregate exposures from a single chemical and identifies factors 
that may contribute to cumulative risk from multiple chemical 
exposures. While the HCS requires employers to provide information on 
SDSs in sections 1-11 and 16 (12-15 are non-mandatory) for workplace 
settings (29 CFR 1910.1200(g)(2)), many consumer products have SDSs 
available to the public through the National Library of Medicine (NLM, 
2020, http://medlineplus.gov/householdproducts.html, Document ID 0059). 
Thus, aggregate exposure information is available to the public for 
many chemicals where occupational, consumer, and environmental 
exposures are possible, as intended by the GHS.
    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 
(US EOP, 2011, Document ID 0057). 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 and the Treasury 
Board of Canada (US-Canada MOU, 2018, Document ID 0199). 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, OSHA is proposing 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 
(Health Canada, 2015, 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 (International/
Globally Harmonized System (GHS), Docket No. OSHA-2016-0005) to inform 
the public that OSHA was beginning rulemaking efforts to maintain 
alignment of the HCS with more recent revisions of the GHS. 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, 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 or voice concerns 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 
United States' 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 conduct senior-level 
discussions to proactively identify and discuss challenges, 
opportunities, and lessons learned regarding Canada-U.S, regulatory 
cooperation'' (US EOP, 2018, Document ID 0252). 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 HCS update in 2012, the agency has 
published guidance documents, issued letters of interpretation (LOI), 
and implemented an enforcement directive. To see the guidance 
documents, please go to OSHA's web page 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 
and is seeking comments in this NPRM on types of guidance documents 
that the public may find useful to understand the updated HCS. Any 
guidance provided will accord with the Department's regulation at 29 
CFR part 89, with a primary aim of providing helpful, plain language 
explanations.
    OSHA has issued several letters of interpretation (LOI) in response 
to questions from the regulated community. These LOI 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 LOI include the labeling of small containers, the labeling of 
chemicals released for shipment, and the use of concentration ranges 
for trade secrets. OSHA's LOI on the HCS may be found at https://www.osha.gov/laws-regs/standardinterpretations/standardnumber/1910/1910.1200%20-%20Index/result. In addition, the agency has published a 
directive that provides guidance to enforcement compliance officers 
intended to ensure uniform enforcement of the standard by the OSHA 
field offices (CPL 02-02-079, OSHA, 2015, Document ID 0007; https://www.osha.gov/OshDoc/Directive_pdf/CPL_02-02-079.pdf). Several of the 
updates in this proposal would codify specific elements of the 
enforcement guidance the agency has already

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provided in the LOI and the directive (see Section XV: Summary and 
Explanation for Regulatory Text, Appendix B and Appendix D).

IV. Need and Support for the Proposed Modifications to the Hazard 
Communication Standard

    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 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.
    OSHA first established the need for the HCS in the 1983 standard 
(48 FR 53282-53284) and most recently reiterated the need for the 
standard in 2012, when OSHA adopted the GHS hazard communication 
framework (77 FR 17584-17600). The 2012 HCS emphasized the need for 
improved quality, consistency, and comprehensibility of information 
provided to workers. The improved information mandated by the current 
HCS enables employers and workers to further reduce risks associated 
with chemical hazards by enabling them to identify and determine the 
hazards and by providing a method to indicate the severity of the 
relevant hazards. The HCS, as updated in 2012, also mandates 
information on proper storage and handling and other information on 
risk mitigation and management. Numerous studies examined in the final 
rulemaking for the 2012 HCS supported the need for a hazard 
communication standard that was focused on ensuring the 
comprehensibility of the conveyed information (77 FR 17584-17585).
    OSHA is now proposing additional changes to the HCS that will serve 
three primary purposes: (1) Maintaining alignment with the GHS and 
ensuring that the standard reflects the current state of science and 
knowledge on relevant topics; (2) cooperating with international 
trading partners and other Federal agencies; and (3) responding to 
stakeholder experiences implementing current HCS requirements. The 
proposed changes include clarifying the purpose and scope of the 
standard, adding definitions, codifying enforcement policies currently 
in OSHA's compliance directive, clarifying requirements related to the 
transport of hazardous chemicals, adding labeling provisions for small 
containers, and adopting new requirements related to preparation of 
SDSs and new provisions related to claiming concentration ranges as 
trade secrets. The agency believes that the changes proposed in this 
NPRM will further improve the comprehensibility and utility of the 
standard and allow the HCS to keep up with advances in relevant science 
and technology, thereby better protecting worker health and safety.

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 the 
2008 ILO report, ``Continuous 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). 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. OSHA has always 
intended for the HCS to be updated periodically to reflect these 
advancements, as is the GHS (for further discussion see Section XIV, 
Issues and Options).\3\
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    \3\ 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 500 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 GHS 
precautionary statements to convey safety and health information 
about workplace chemicals in a consistent, internationally-
accessible manner. With participation by experts from government 
agencies around the world, including the U.S. (CDC/NIOSH), Canada 
(Health Canada and Environment Canada), and the European Commission 
(ECHA), 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 proposed changes to the HCS will result in better alignment 
between the standard and the continually-evolving GHS. The first 
edition of the UN GHS, adopted in December 2002 and published in 2003, 
implemented the 16-section format for SDSs that is now standard across 
much of the globe. As information has improved, the GHS has updated the 
form and content of SDSs \4\ to improve readability, minimize 
redundancies, and ensure hazards are communicated appropriately (UN 
GHS, 2017, Document ID 0060; ANS revises standard, 2005, Document ID 
0237).
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    \4\ 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 
updates to the HCS indicates that aligning the HCS with the GHS has had 
a positive impact. Data from published studies indicate that the hazard 
communication approach taken in the 2012 HCS has been effective, when 
implemented appropriately, in enabling workers to understand, avoid, 
and mitigate exposures to hazardous chemicals in the workplace 
(Bechtoldt, 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 
provided an opportunity to address distinctions between acute toxicity 
and chronic health effects (Bechtold, 2014, Document ID 0061). In 
reference to SDSs, one industry representative stated that ``[b]ecause 
the standardized hazard statements and classifications are so precisely 
disclosed, it'll be a lot easier for industrial hygienists to identify 
the more hazardous chemicals, decide where they may need to take 
action, and compare the hazards of one product versus another.'' 
(Bechtold, 2014,

[[Page 9582]]

Document ID 0061; Elliot, 2016, Document ID 0119). 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).
    Several studies published since the 2012 HCS adopted the 16-section 
SDS format indicate that the new format improves comprehension in the 
workplace (Elliott, 2016, Document ID 0119; Boelhouwer, 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 protections. 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 0116; 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 0067).
    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. 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. Using 
information gained through the experience of global stakeholders, the 
GHS is updated with revisions and improvements every two years. These 
changes have been outlined in brief in Section III (Events Leading to 
the Proposed Modifications to the Hazard Communication Standard) of 
this NPRM. The proposed 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, the change in section 9 (physical 
characteristics to include particle characteristics) will identify 
exposure issues that are not addressed by the current 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 on skin corrosion/irritation that incorporated new in vitro 
test methods, and computational and in silico techniques, to classify 
chemicals for this category of hazard (UN GHS, 2018, 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).\5\ 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; Ta, 2010, 
Document ID 0115; Ta, 2011, Document ID 0194; Chan, 2017, Document ID 
0017).
---------------------------------------------------------------------------

    \5\ Holistic programs such as NIOSH's Total Worker Health (TWH) 
program, where behavioral science is integrated into more 
traditional risk-management practices, require robust hazard 
communication practices (Tamers, 2019, Document ID 0076).
---------------------------------------------------------------------------

    In addition to directly enhancing worker protections through 
improved hazard communication, updating the HCS (based on the GHS) will 
also improve the availability of important information to support 
larger efforts to address workplace hazards. For example, NIOSH is 
exploring the use of aggregate exposures (exposures to a specific 
chemical or hazard from several different sources) and cumulative risk 
models for use in setting occupational exposure limits and assessing 
impacts on worker health (Lentz, 2015, Document ID 0071; Redingert, 
2015, Document ID 0100). A real-world example of the potential effects 
of aggregate exposure comes from the increased use of nanosilver in 
consumer products. A recent NIOSH review of nanosilver indicates that 
the current OSHA PEL for silver is adequate to protect workers from 
silver's adverse health effects (NIOSH, 2018, Document ID 0188). 
However, a 2013 study looking at the increased presence of nanosilver 
in consumer products (e.g., use of nanosilver as an antimicrobial in 
clothing and materials that come into contact with food), and the 
increased environmental exposures from the manufacture, use, and 
disposal of these consumer products, indicates that the OSHA PEL may be 
inadequate to protect workers if nanosilver continues to be added to 
new consumer products (Balcher, 2013, Document ID 0097). This example 
highlights the importance of an effective overarching hazard 
communication strategy in understanding and managing exposures and 
risk.
    Regularly updating the HCS to align with international practices 
also eases compliance for regulated entities 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 (API, 2009, 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), and the Society for Chemical Hazard Communication (SCHC)) have 
publicly supported OSHA's continued updates to the HCS (see 77 FR 
17585, 17603, 17604). The Society of Toxicology has also expressed 
support for updating the HCS to align with the GHS as this ``is ani 
important step toward creating consistent communication about the 
hazards of chemicals used around the world.'' (see 77 FR 17585).

[[Page 9583]]

B. Cooperating With International Trading Partners and Other Federal 
Agencies

    In support of the second goal of this NPRM, OSHA expects that the 
proposed updates to the HCS will facilitate cooperation with 
international trading partners and other Federal agencies. With respect 
to the U.S. and Canada specifically, the two countries participate in 
the RCC, which has a goal to ``reduce, eliminate, or prevent 
unnecessary regulatory differences between both countries while 
maintaining high levels of protection for health, safety, and the 
environment'' (US-Canada MOU, 2018, Document ID 0252). 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 UN GHS subcommittee (see 
Section III, Events Leading to the Proposed Modifications to the Hazard 
Communication Standard). In addition, OSHA and Health Canada share 
regular updates on regulatory activity. As explained in the Summary and 
Explanation (see Section XV), a number of the updates OSHA is proposing 
in this NPRM would 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 proposing to update the requirements for bulk 
shipment under paragraph (f)(5), Transportation to provide additional 
clarity for shipments that are also regulated by the U.S. Department of 
Transportation (DOT). For bulk shipments, the proposed new paragraph 
would 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. And in another effort to facilitate inter-agency 
cooperation, OSHA is proposing 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.

C. Responding to Stakeholder Experiences Implementing the 2012 HCS

    Finally, some of the proposed changes in this NPRM, 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). The proposed updates to the HCS related to the 
labeling of small containers are designed to address these issues. 
Furthermore, OSHA believes that adopting a uniform standard for the 
labeling of small containers will enhance worker protections by 
providing more clarity and certainty about the hazards posed by the 
chemicals contained in such containers (see Section X Summary and 
Explanation for (f)(12), Small container labelling).
    Similarly, the proposed 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 paragraph (f)(11), 
especially in the case of chemicals that travel through long 
distribution cycles (Kenyon, 2017, Document ID 0182). 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 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 (NGFA, 2016, Document ID 
OSHA-2016-0005-0018; AFIA, 2016, Document ID OSHA-2016-0005-0017). OSHA 
believes the proposed revisions to paragraph (f)(11) to provide that 
relabeling is not required for chemicals that have been released for 
shipment and are awaiting future distribution will accommodate these 
concerns; the proposal would also maintain worker protections by 
requiring the chemical manufacturer or importer to provide an updated 
label for each individual container with each shipment.

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 
pursuant to 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, he 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)

[[Page 9584]]

(``Benzene''). As explained more fully below, OSHA need not make 
additional findings on risk for this proposal because OSHA previously 
determined that the HCS addresses a significant risk. 77 FR 17603-
17604.
    In promulgating a standard under, and making the determinations 
required by, the OSH Act, OSHA's determinations will be deemed 
conclusive if they are ``supported by substantial evidence in the 
record considered as a whole.'' 29 U.S.C. 655(f). OSHA must use the 
``best available evidence,'' which includes ``the latest available 
scientific data in the field''; ``research, demonstrations, 
experiments, and such other information as may be appropriate''; and 
``experience gained under this and other health and safety laws.'' 29 
U.S.C. 655(b)(5).

B. Authority--Section 6(b)(5)

    The HCS is a health standard promulgated under the authority of 
section 6(b)(5) of the OSH Act. See Associated Builders & Contractors, 
Inc. v. Brock, 862 F.2d 63, 67-68 (3d Cir. 1988); United Steelworkers 
of Am. v. Auchter, 763 F.2d 728, 735 (3d Cir. 1985); 77 FR 17601. 
Section 6(b)(5) of the OSH Act provides that in promulgating health 
standards dealing with toxic materials or harmful physical agents, the 
Secretary must ``set the standard which most adequately assures, to the 
extent feasible, on the basis of the best available evidence, that no 
employee will suffer material impairment of health or functional 
capacity even if such employee has regular exposure to the hazard dealt 
with by such standard for the period of his working life.'' 29 U.S.C. 
655(b)(5). Thus, once OSHA determines that a significant risk due to a 
health hazard is present and that such risk can be reduced or 
eliminated by an OSHA standard, section 6(b)(5) requires OSHA to issue 
the standard, based on the best available evidence, that ``most 
adequately assures'' employee protection, subject only to feasibility 
considerations. As the Supreme Court has explained, in passing section 
6(b)(5), Congress ``place[d] . . . worker health above all other 
considerations save those making attainment of this `benefit' 
unachievable.'' Am. Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490, 
509 (1981) (``Cotton Dust'').

C. Other Authority

    The HCS is also promulgated under the authority of section 6(b)(7) 
of the OSH Act. See United Steelworkers, 763 F.2d at 730; 77 FR 17601. 
Section 6(b)(7) of the OSH Act provides in part: ``Any standard 
promulgated under this subsection shall prescribe the use of labels or 
other appropriate forms of warning as are necessary to insure that 
employees are apprised of all hazards to which they are exposed, 
relevant symptoms and appropriate emergency treatment, and proper 
conditions and precautions of safe use or exposure.'' 29 U.S.C. 
655(b)(7). Section 6(b)(7)'s labeling and employee warning requirements 
provide basic protections for employees in the absence of specific 
permissible exposure limits, particularly 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 by 
rule promulgated pursuant to section 553 of Title 5, make appropriate 
modifications in the foregoing requirements relating to the use of 
labels or other forms of warning, monitoring or measuring, and medical 
examinations, 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 the current proposal.
    This proposal to update the HCS fits well within the authority 
granted by the last sentence of section[thinsp]6(b)(7). The changes 
proposed would 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 believes the proposed updates to be 
``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 may be 
considered a ``technological development'' that has occurred since the 
promulgation of the HCS in 2012 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.\6\ See also Section 
III of this preamble, Events Leading to the Proposed Modifications to 
the Hazard Communication Standard.
---------------------------------------------------------------------------

    \6\ The last sentence of section 6(b)(7) requires consultation 
with the Secretary of Health and Human Services. OSHA briefed NIOSH 
on this proposal during a collaboration meeting held in December 
2018, which was attended by the Director of NIOSH, and NIOSH 
expressed its support. NIOSH 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 for standards promulgated under section 6(b)(5) of the 
OSH Act, OSHA determined that the HCS would substantially reduce a 
significant risk of material harm. Most 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 these cases, OSHA measures and 
assesses the hazards of employee exposures in order 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 in 1983. 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

[[Page 9585]]

53283. OSHA determined that the HCS addressed a significant risk 
because ``inadequate communication about serious chemical hazards 
endangers workers,'' and that the practices required by the standard 
were ``necessary or appropriate to the elimination or mitigation of 
these hazards.'' 48 FR 53321. The U.S. Court of Appeals for the Third 
Circuit agreed that ``inadequate communication is itself a hazard, 
which the standard can eliminate or mitigate.'' United Steelworkers, 
763 F.2d at 735. That court has upheld OSHA's determination of 
significant risk as sufficient to justify the HCS. See Associated 
Builders & Contractors, 862 F.2d at 67-68 (discussing the history of 
its review of the issue).
    OSHA reaffirmed its finding of significant risk in adopting 
revisions to the HCS in 1994. See 59 FR 6126-6133. When revising the 
HCS to adopt the GHS model in 2012, OSHA found that there remained a 
``significant risk of inadequate communication'' of chemical hazards in 
the workplace and that adopting the standardized requirements of the 
GHS would substantially reduce that risk by improving chemical hazard 
communications. 77 FR 17603-17604.
    In previous rulemakings, OSHA rejected suggestions that the hazard 
assessment and communication obligations of the HCS should arise only 
where the downstream use creates a significant risk because it is 
difficult, if not impossible, for OSHA or manufacturers and importers 
to know in advance where these risks might occur. See 48 FR 53295-
53296; 59 FR 6132. Further, it is only by the provision of hazard 
information that downstream employers and employees can determine how 
to use the chemical so that exposure and risk may be minimized. See 48 
FR 53295-53296; 59 FR 6132. Thus, the HCS protects employees from 
significant risk by requiring communications about all chemicals that 
may present a hazard to employees, regardless of the exposure or risk 
levels any particular downstream user might actually experience. See 
Durez Div. of Occidental Chem. Corp. v. OSHA, 906 F.2d 1, 3-4 (D.C. 
Cir. 1990); Gen. Carbon Co. v. OSHRC, 860 F.2d 479, 484-85 (D.C. Cir. 
1988).
    For the changes proposed in this NPRM, OSHA has not made a new 
preliminary finding of significant risk, but is proposing 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.\7\ See 77 
FR 17602.
---------------------------------------------------------------------------

    \7\ 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 analysis 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.'' Cotton Dust, 
452 U.S. 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. As discussed more fully in Section 
VII.E of this preamble, Technological Feasibility, OSHA has 
preliminarily determined that compliance with the proposed revisions to 
the HCS is technologically feasible for all affected industries because 
compliance can be achieved with readily and widely available 
technologies. As discussed more fully in Section VII.G, Economic 
Feasibility and Impacts, OSHA has preliminarily determined that the 
proposed changes to the HCS are economically feasible because employers 
can comply without threatening the long-term profitability or 
competitive structure of any affected industries.

VI. OMB Review Under the Paperwork Reduction Act of 1995

A. Overview

    OSHA is proposing to revise the Hazard Communication Standard 
(HCS), 29 CFR 1910.1200, which contains collection of information that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et 
seq., and OMB regulations at 5 CFR part 1320. The agency is planning to 
revise and update 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

[[Page 9586]]

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.

B. Solicitation of Comments

    OSHA prepared and submitted an Information Collection Request (ICR) 
to OMB proposing to revise certain collection of information currently 
contained in that paperwork package in accordance with 44 U.S.C. 
3507(d). The agency solicits comments on the revision of the collection 
of information requirements and reduction in estimated burden hours 
associated with these requirements, including comments on the following 
items:
     Whether the collection of information are necessary for 
the proper performance of the agency's functions, including whether the 
information is useful;
     The accuracy of OSHA's estimate of the burden (time and 
cost) of the collection of information, including the validity of the 
methodology and assumptions used;
     The quality, utility, and clarity of the information 
collected; and
     Ways to minimize the compliance burden on employers, for 
example, by using automated or other technological techniques for 
collecting and transmitting information.

C. Proposed 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.
    2. Description of the ICR: The proposal would revise the currently 
approved Hazard Communication ICR and change the existing collection of 
information requirements currently approved by OMB.
    3. Brief Summary of the Information Collection Requirements: This 
proposal would revise and clarify the collection of information 
contained in the existing ICR. Specifically, OSHA is proposing to (1) 
add to paragraph (d)(1) that the chemical manufacturer or importer 
shall 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 requires updated labels 
accompany each shipment; and (5) add new labeling requirements for 
small containers at paragraph (f)(12). See Table 1.
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    4. OMB Control Number: 1218-0072.
    5. Affected Public: Business or other for-profit.
    6. Number of Respondents: 2,206,700.
    7. Frequency of Responses: Varies.

[[Page 9590]]

    8. Number of Reponses: 74,019,955.
    9. Average Time per Response: Varies.
    10. Estimated Annual Total Burden Hours: 7,023,513.
    11. Estimated Annual Total Cost (Operation and maintenance): 
$45,676,443.

D. Submitting Comments

    Members of the public who wish to comment on the revisions to the 
paperwork requirements in this proposal must send their written 
comments to the Office of Information and Regulatory Affairs, Attn: OMB 
Desk Officer for the Department of Labor, OSHA (RIN-1218-AC93), Office 
of Management and Budget, Room 10235, Washington, DC 20503, email: 
OIRA_submission@omb.eop.gov. The agency encourages commenters also to 
submit their comments on the paperwork requirements to the rulemaking 
docket (Docket Number OSHA-2019-0001) along with comments on other 
parts of the proposed rule. For instructions on submitting these 
comments to the rulemaking docket, see the sections of this Federal 
Register document titled DATES and ADDRESSES. Comments submitted in 
response to this document are public records; therefore, OSHA cautions 
commenters about submitting personal information such as Social 
Security numbers and dates of birth.

E. Docket and Inquiries

    To access the docket to read or download comments and other 
materials related to this paperwork determination, including the 
complete ICR (containing the Supporting Statement with attachments 
describing the paperwork determinations in detail) use the procedures 
described under the section of this document titled ADDRESSES.
    You also may obtain an electronic copy of the complete ICR by 
visiting the web page at: http://www.reginfo.gov/public/do/PRAMain, 
scroll under ``Currently Under Review'' to ``Department of Labor 
(DOL)'' to view all of the DOL's ICRs, including those ICRs submitted 
for proposed rulemakings. To make inquiries, or to request other 
information, contact Ms. Seleda Perryman, Directorate of Standards and 
Guidance, telephone (202) 693-2222.

VII. Preliminary Economic Analysis and Initial Regulatory Flexibility 
Analysis

A. Introduction and Summary

    Under Executive Order 12866, OMB's Office of Information and 
Regulatory Affairs (OIRA) determines whether a regulatory action is 
significant and, therefore, subject to the requirements of Executive 
Order 12866 and OMB review. Section 3(f) of Executive Order 12866 
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 
$100 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 economically significant); (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 Executive Order 12866. Upon review, OMB has 
determined that this proposed rule is a significant regulatory action 
(``Other Significant'') under Executive Order 12866. 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).
    OSHA has made a preliminary determination that this action is not 
an economically significant regulatory action under section 3(f)(1) of 
Executive Order 12866 because it is not likely to have an annual effect 
on the economy of $100 million or more. This proposed rule is expected 
to be an Executive Order 13771 deregulatory action. Details on the 
estimated cost-savings of this rule can be found in the economic 
analysis below. Executive Order 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. Executive Order 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.
    OSHA has prepared this Preliminary Economic Analysis (PEA), 
including a Preliminary Regulatory Flexibility Analysis Certification, 
for the proposed modifications to the HCS. Supporting materials 
prepared by OSHA (including spreadsheets) are available in the public 
docket for this rulemaking, Docket ID OSHA-2019-0001, through 
www.regulations.gov. OSHA invites comment on any aspects of this PEA.
    In this PEA, OSHA estimates that the proposed amendments to the HCS 
would result in annualized net cost savings of $26.8 million at a 7 
percent discount rate. Annualized at a 3 percent discount rate, OSHA 
estimates that the proposed amendments to the rule would lead to net 
cost savings of $27.5 million per year. Under a perpetual time horizon 
to allow for cost comparisons under Executive Order 13771, OSHA 
estimates that at a discount rate of 7 percent the net cost savings of 
the proposed amendments to the HCS would be $19.6 million per year in 
2016 dollars.\8\ OSHA expects that the proposed revisions to the HCS 
would 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.
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    \8\ This calculation (a) converts the costs and cost savings of 
the rule from 2019 dollars to 2016 dollars using the BEA (2020) 
implicit price deflator for Gross Domestic Product, and (b) 
discounts the first year costs by five years, to reflect the five 
years between 2016 and 2021, the scheduled year of publication of 
this NPRM. For further details, see Document ID 0049, tab Tables, 
E.O. 13771 Summary Table.
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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 current HCS 
contains a set of requirements for chemical products, including 
mandatory hazard classification, labeling requirements, provisions for 
providing detailed information (in SDSs), and label updating 
requirements. These requirements are based on Revision 3 of the GHS, 
which was adopted by the UN Committee and Sub-Committee of Experts on 
the GHS in December 2008.
    OSHA has preliminarily determined that the proposed revisions to 
the HCS would make employers' hazard communication programs more 
worker-protective, efficient, and effective through standardizing 
practices nationally and internationally. In addition, aligning with 
the GHS Rev. 7 would continue to facilitate

[[Page 9591]]

international trade, as a number of U.S. trading partners are also 
preparing to align with the GHS Rev. 7.
    The proposed revisions to the HCS include the following notable 
changes to improve the U.S. hazard communication system:

 Maintain 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.
 Address issues identified in implementing the HCS 2012
    [cir] Updating labeling requirements for small containers; and
    [cir] Updating labeling requirements for packaged containers that 
have been released for shipment.

    As discussed in Section F of this PEA, the estimated costs and cost 
savings resulting from the proposed 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 proposed 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 proposed changes to appendices C and D); (2) the cost of 
management familiarization and other management-related costs 
(associated with all of the proposed revisions to the standard); (3) 
the cost of training employees as necessitated by the proposed changes 
to the HCS (see existing 29 CFR 1910.1200(h)(1)); (4) the cost savings 
resulting from the new released-for-shipment provision (proposed 
revisions to 29 CFR 1910.1200(f)(11)); and (5) the cost savings from 
limiting labeling requirements for certain very small containers 
(proposed 29 CFR 1910.1200(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 proposed changes to the HCS would maintain the uniformity of 
hazard information with the GHS and would, 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 (Hemenway, 1975, Document ID 0050). 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.\9\
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    \9\ 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 alignment with the GHS Rev. 
7. In some cases (e.g., aerosols, desensitized explosives), the GHS 
Rev. 7 contains different hazard classes or classification criteria 
than the current HCS, and it would be impermissible for a manufacturer 
to comply with the GHS Rev. 7 rather than the criteria in the existing 
HCS. Moreover, making compliance with the latest revision of the GHS 
optional undermines the goal of harmonizing classification criteria and 
label elements. Second, while the costs of creating SDSs and labels are 
borne directly by the chemical producers, maintaining alignment with 
the GHS benefits the users of hazardous chemicals. These users include 
employers who are direct customers of chemical manufacturers, employees 
who use or are exposed to workplace chemicals, and emergency responders 
who typically have no market relationship with the chemical producers. 
Even if market forces could ensure the socially optimal approach to 
SDSs between chemical manufacturers and their customers, there are 
limited market forces at work between the chemical manufacturer and two 
key sets of users--the employees and the emergency response community. 
Therefore, the benefits achieved by maintaining alignment with the GHS 
are unlikely to be obtained in the private market without regulation.
    OSHA recognizes that there will be some market pressure to align 
with the GHS Rev. 7 as its adoption expands internationally.\10\ 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.\11\ Nonetheless, even the small 
percentage of U.S. companies that only conduct business domestically 
are required to identify and communicate hazards to workers under the 
HCS. 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

[[Page 9592]]

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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    \10\ See https://www.unece.org/fileadmin/DAM/trans/doc/2018/dgac10c4/ST-SG-AC10-C4-70e.pdf, pp. 12-13 (UN GHS, 2018, Document ID 
0040).
    \11\ 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). See https://usitc.gov/research_and_analysis/trade_shifts_2019/chemicals.htm, accessed 
October 2, 2020 (Document ID 0234). The International Trade 
Administration reported that the U.S. chemical industry accounted 
for 18 percent of global chemical shipments. See https://www.selectusa.gov/chemical-industry-united-states, accessed October 
2, 2020 (Document ID 0236). 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. See https://www.americanchemistry.com/Policy/Trade/US-Chemicals-Trade-by-the-Numbers.pdf, accessed October 2, 2020 
(Document ID 0235).
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    The proposed changes to the HCS would involve costs and cost 
savings mainly for manufacturers and importers. Manufacturers and 
importers of chemicals would also achieve benefits--in part because 
they themselves benefit as both producers and users, and in part as a 
result 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 VII.D. Health and Safety 
Benefits and Unquantified Positive Economic Effects).
    Of more significance to the concerns of the OSH Act, the proposed 
changes would also provide health benefits from improved hazard 
classification and communication; although unquantified in this 
proposal, these benefits would include reductions in worker illnesses, 
injuries, and fatalities (see additional discussion below in VII.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 which have direct market 
relationships with each other, OSHA believes maintaining a single, 
uniform standard can best achieve the full benefits available from a 
hazard communications system.

C. Profile of Affected Industries, Establishments, and Employees

    The proposed modifications to the standard include revised criteria 
for classification of certain health and physical hazards; revised 
labeling provisions for small containers and packages that have been 
released for shipment; revised trade secret disclosure requirements; 
updates to certain aspects of SDSs and precautionary statements; and 
related revisions to definitions of terms used in the standard.
    In this section, OSHA presents a preliminary profile of industries 
affected by this proposal to revise the HCS. The profile data in this 
section are based upon the 2012 HCS final economic analysis (FEA), 
updated in this PEA with the most recent data available.
    As a first step, OSHA identifies the North American Industry 
Classification System (NAICS) industries affected by the proposed 
changes to the HCS. 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.\12\ 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), 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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    \12\ 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. (U.S. Census 
Bureau, Document ID 0047).
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    The revisions to the HCS would affect establishments in a variety 
of different industries in which employees are exposed to hazardous 
chemicals or in which hazardous chemicals are produced. The proposed 
changes to the HCS are not expected to change the overall list of 
affected industries or establishments. However, the changes are 
expected to affect certain establishment groupings that manufacture 
aerosols, desensitized explosives, and flammable gases. These proposed 
changes are also expected to 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 proposed 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 current 
version of the HCS. Therefore, OSHA believes that the revisions would 
have little or no effect on whether specific establishments fall within 
the scope of the standard. OSHA requests comments on its preliminary 
determinations about the scope of the proposed revisions to the HCS and 
the details within the industrial profile presented in this section.
    OSHA's estimates of the number of employees who will require new 
training under the proposed revisions to the standard are based on BLS' 
(2020) Occupational Employment Statistics data for May 2019, 
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 would be affected by the proposed 
requirements to reclassify aerosols, desensitized explosives, and 
flammable gases.\13\ (See the analysis and discussion of training costs 
below in VII.F. Compliance Costs and Cost Savings.)
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    \13\ The NAICS industries estimated to be affected by the 
proposed 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, 2020). Occupational 
Employment Statistics--May 2019 (Released March 3, 2020). Available 
at https://www.bls.gov/oes/#data (Accessed April 3, 2020) (Document 
ID 0223).
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    Table VII-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 VII-2 and VII-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

[[Page 9593]]

these tables update the estimates provided in the FEA in support of the 
2012 HCS final rule (Document ID 0005, Section VI) and rely on the most 
recent comprehensive set of data (including revenues) available from 
the U.S. Census Bureau (2020a; 2020b).\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 SBA, 
2019, Document ID 0225).
    \16\ U.S. Census Bureau, Statistics of U.S. Businesses, 2017 
https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html (Document ID 0231) and https://www.census.gov/data/datasets/2017/econ/susb/2017-susb.html (Document ID 0232) (accessed 
August 14, 2020).

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    The costs and cost savings of some of the proposed provisions (new 
classification criteria for select hazards and labels on very small 
containers) are

[[Page 9607]]

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 to follow later 
in this PEA, Table VII-4 presents OSHA's preliminary 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 
VII-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 17640), 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 proposed in paragraph (f)(12). Also, the term ``jug'' has 
been changed to the more generic term ``container.'' The figures in 
Table VII-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.

                       Table VII-4--Chemical Container Estimated Typical Shipment Weights
----------------------------------------------------------------------------------------------------------------
                                                         Estimated shipment weight (lbs.)            Number of
                                                 ------------------------------------------------   labels per
                 Container type                                                                     container a
                                                      Minimum         Typical         Maximum
----------------------------------------------------------------------------------------------------------------
3 ml container..................................            0.01            0.01            0.01            1.13
30 ml container.................................            0.06            0.08            0.13            1.13
60 ml container.................................            0.12            0.16            0.26            1.13
125 ml container................................            0.25            0.33            0.54            1.13
250 ml container................................            0.50            0.67            1.08            1.13
500 ml container................................            0.92            1.26            2.08            1.13
1 liter container...............................            1.84            2.51            4.16            1.25
2 liter container...............................            3.57            4.92            8.22            1.25
1 gallon container..............................            6.83            9.38           15.63            1.25
2.5 gallon container............................           18.00           24.38           40.00            1.50
5 gallon drum...................................           34.95           47.71           78.95            1.00
30 gallon drum..................................          202.00          278.56          466.00            1.00
55 gallon drum..................................          371.00          511.37          855.00            1.00
275 gallon tote.................................        1,830.00        2,531.84        4,250.00            1.00
330 gallon tote.................................        2,196.00        3,038.21        5,100.00            1.00
Tank Truck--5.5k g..............................       34,100.00       48,136.79       82,500.00            0.00
Tank Truck--7.0k g..............................       43,400.00       61,265.00      105,000.00            0.00
Rail Car--20k g.................................      128,805.00      181,825.77      311,625.00            0.00
Rail Car--30k g.................................      186,000.00      262,564.29      450,000.00            0.00
Barge...........................................    2,670,774.00    3,770,160.58    6,461,550.00            0.00
----------------------------------------------------------------------------------------------------------------
a Assumes 8 units per package for containers smaller than 1 liter, 4 units per package for containers from 1
  liter to 1 gallon in volume, and 2 units per package for 2.5-gallon containers.
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.

    As will be discussed at greater length below in Section VII.F. 
Compliance Costs and Cost Savings, 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. In this 
PEA, the terms ``electronic templates'' and ``electronic files'' are 
used interchangeably with, and as proxies for, the term ``SDS.'' All 
three terms refer to the electronic files that are used to generate 
SDSs and labels. Table VII-5 provides, by covered NAICS industry, 
estimates of the total number of labels, the number of labels on very 
small containers (containers of 3 ml capacity or less), the total 
number of SDSs, and the number of labels and SDSs affected by the 
proposed revisions to the HCS classification criteria. The term ``SDS'' 
in the column headers and in the discussion below represents the 
estimated number of electronic templates (files) that are used to 
create SDSs and labels. The derivation of these estimates is discussed 
below. OSHA invites public comment on its understanding about the use 
of electronic template files to create SDSs and labels.
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BILLING CODE 4510-26-C
    OSHA's estimate of the total number of SDSs per NAICS industry, as 
presented in Table VII-5, was developed by its contractor to support

[[Page 9610]]

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 VII-5). Although OSHA has preliminarily determined that this 
methodology remains sound, the agency invites public comment on the 
reasonableness of this methodology for the current analysis.
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    \18\ Technical and analytical support for this preliminary 
economic analysis was provided by Eastern Research Group, Inc. 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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    OSHA's estimate of the number of labels per NAICS industry is 
constructed using the same methodology developed in the 2012 HCS final 
rule (Document ID 0005, pp. 17634-17643), but with more recent data. 
The steps in the analysis, elaborated on below, can be summarized 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.
    The label analysis begins 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).\20\ This 
estimate is used in conjunction with another CFS dataset (U.S. Census 
Bureau, 2014b, Document ID 0030) 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.
---------------------------------------------------------------------------

    \20\ 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 this PEA, the final 2017 CFS data was not 
yet available. Therefore, 2012 CFS data was the most recent 
information available. OSHA requests public comments on the 
estimated percentages for the transported goods identified as 
hazardous non-consumer products in this preliminary profile.
---------------------------------------------------------------------------

    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. 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 was 
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 VII-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 (2020a; 2020b) 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 VII-5.\21\
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    \21\ 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 VII-4, the analysis led to an 
estimate of the total number of labels (474,629,165) required by all 
SCTG Code 20 manufacturers (see Document ID 0049, tab ``Labels per 
NAICS'', cell O11). The percentage of receipts (22.3 percent) for 
NAICS 211130 relative to total receipts for SCTG Code 20 employers 
(Document ID 0049, tab ``Labels per NAICS'', cells N11-P11) was then 
applied to this total number of labels. The result, shown in Column 
3 in Table VII-5, is an estimated 105,723,103 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).
---------------------------------------------------------------------------

    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

[[Page 9611]]

labels on very small containers is shown in Column 4 of Table VII-5.
    Not every SDS and label, and not every label on very small 
containers, would be affected by the proposed rule. Only SDSs and 
labels for certain products (aerosols, desensitized explosives, and 
flammable gases) would be affected by the new classification criteria. 
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 proposed 
paragraph (f)(12)(iii), only a product identifier would be required on 
the immediate outer package of very small containers (3 ml or less) 
where the manufacturer, importer, or distributor can demonstrate that a 
label would interfere with the normal use of the container and that it 
is not feasible to use pull-out labels, fold-back labels, or tags 
containing the full label information. Thus, in addition to the 
estimated total number of SDSs, labels, and labels on very small 
containers, Table VII-5 shows the number of each estimated to be 
affected by this proposed rule.\22\
---------------------------------------------------------------------------

    \22\ Note that OSHA's cost estimates for reclassifying affected 
chemicals and revising the corresponding SDSs and labels to achieve 
consistency with the reclassification (per proposed 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 proposed 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 proposed rule. They are not based on the number 
of labels or SDSs actually produced or used.
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    Tables VII-6 and VII-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 IRS (2016) SOI Tax Stats--Corporation Source Book 
profit data for each of the 14 years 2000-

[[Page 9616]]

2013.\23\ Table VII-9 presents estimates of total revenues and total 
profits by NAICS industry code for all entities, small entities, and 
very small entities affected by this proposed rule. OSHA calculated 
total profits per NAICS industry by multiplying the average profit rate 
(NAICS industry) (IRS, 2016, Document ID 0004) by total revenues (NAICS 
industry) (U.S. Census Bureau, 2020a, Document ID 0231; U.S. Census 
Bureau, 2020b, Document ID 0232).
---------------------------------------------------------------------------

    \23\ IRS, 2016, Document ID 0004.
---------------------------------------------------------------------------

    Table VII-10 shows, by NAICS industry code, OSHA's best estimates 
of the percentage of establishments or entities estimated to be 
affected for each element of the proposed revisions to the HCS that is 
projected to result in costs (see Section VII.F. Compliance Costs and 
Cost Savings in this PEA for an explanation of the cost categories 
presented in this table).\24\
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    \24\ Note that the provisions that are projected to result in 
cost savings are not included in Table VII-10 because, for those 
provisions, OSHA estimates a percentage of product, rather than a 
percentage of entities or establishments, that would be affected.
---------------------------------------------------------------------------

    Finally, Table VII-11 summarizes key estimates for the combined 
covered industries, labels, and SDSs affected by this proposed rule. 
The data in this table are drawn from profile tables presented earlier 
in this PEA and summarize both the magnitude of the global profile 
metrics (within the scope of Federal OSHA jurisdiction) and the 
magnitude of affected inputs critical to the agency's analysis of 
preliminary economic impacts.

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 Table VII-11--Characteristics of Industries and Labels/SDSs Affected by OSHA's Proposed Revisions to the HCS a
----------------------------------------------------------------------------------------------------------------
                                                                                    Percentage
                                                                       Total         affected        Affected
----------------------------------------------------------------------------------------------------------------
Firms...........................................................       6,077,430            1.91         115,758
Establishments..................................................       7,780,863            1.96         152,427
Relevant Employees..............................................     148,004,068            2.82       4,178,738
Labels Being Revised Due to Chemical Reclassification and Labels   1,512,219,200           63.55     961,053,993
 Revisions......................................................
Labels for Very Small Containers................................     147,599,473           17.21      25,394,066
Firms w/Warehoused Labels that Change...........................             230            1.00            2.30
SDSs............................................................       1,519,506           94.40       1,434,377
----------------------------------------------------------------------------------------------------------------
Sources: U.S. Census Bureau, 2020a (Document ID 0231); U.S. Census Bureau, 2020b (Document ID 0232); U.S. Census
  Bureau, 2019a (Document ID 0227); BLS, 2020 (Document ID 0223); U.S. DOL, OSHA, Directorate of Standards and
  Guidance, Office of Regulatory Analysis-Health.
Note: Due to rounding, data derived by applying the percentages shown in the table to the figures shown in the
  ``Total'' column may not be identical to the figures shown in the ``Affected'' column.
a The data in this table are drawn from tables presented earlier in this PEA (for firms, establishments and
  employees, see Table VII-1; for labels and SDSs, see Table VII-5).

D. Health and Safety Benefits and Unquantified Positive Economic 
Effects

    As part of the rulemakings that resulted in 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 1983 and 1987 rulemakings, 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 (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 one 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, these proposed revisions to the 
HCS are incremental and minor. Accordingly, OSHA expects that the 
proposed 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 proposed 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 the GHS 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 proposed 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, packaged 
containers to replace labels when new hazards were identified.
    Although OSHA expects that the proposed revisions to the HCS would 
reduce injuries, illnesses, and fatalities, the limited scope and 
nature of the changes being proposed have led OSHA to a preliminary 
determination that it cannot reasonably quantify an estimate of how 
many injuries, illnesses, and fatalities would be prevented. As the 
agency noted in the 2012 FEA, any assessment of benefits that are 
incremental to the original estimated benefits, e.g., benefits 
associated with minor improvements to an existing standard, broaden the 
range of uncertainty associated with the original estimates (77 FR 
17621).\25\ OSHA invites interested parties to provide comments and 
evidence on how the proposed revisions to the HCS are likely to affect 
worker safety and health.
---------------------------------------------------------------------------

    \25\ As described above, OSHA estimated that the 2012 revisions 
to the HCS would result in benefits equal to one 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)
---------------------------------------------------------------------------

    In addition to the aforementioned health and safety benefits, OSHA 
expects that the proposed revisions to the HCS would result in other 
positive economic effects. For example, being better aligned with the 
GHS would 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 would 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.\26\ Maintaining alignment with the GHS in U.S. laws and 
policies through appropriate legislative and

[[Page 9630]]

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.\27\
---------------------------------------------------------------------------

    \26\ The EU, Canada, Australia, and New Zealand have also 
indicated that they are proposing updates to align with the 7th 
revision to the GHS (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).
    \27\ https://2009-2017.state.gov/e/oes/eqt/chemicalpollution/83012.htm (SAICM, 2006, Document ID 0039).
---------------------------------------------------------------------------

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 would be imposed by the 
proposed rule and has assessed their technological feasibility. As a 
result of this review, OSHA has preliminarily determined that 
compliance with the requirements of the rule is technologically 
feasible for all affected industries.
    The proposed revisions to OSHA's HCS would 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 would mainly involve revisions to the presentation of 
information and is not expected to involve any technological obstacles.
    The proposed changes to the requirements for the labeling of very 
small containers, which would eliminate full labeling requirements for 
some containers with a volume capacity of 3 ml or less, is expected to 
address current feasibility issues related to labeling these small 
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 proposal would 
require the container to bear only the product identifier, which could 
be etched onto the container itself. Similarly, the proposed released-
for-shipment provisions would 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 requests public comment on any employer concerns associated with 
the proposed provision for labeling very small containers or with the 
proposed provision addressing the relabeling of containers that have 
been released for shipment.
    OSHA has preliminarily determined that compliance with all of the 
requirements of the proposed revisions to the HCS can be achieved with 
readily and widely available technologies. No new technologies are 
required for compliance with the proposed modifications to the HCS. 
Therefore, OSHA believes that there are no technological constraints 
associated with compliance with any of the proposed revisions to the 
HCS. OSHA invites comment on these preliminary findings of 
technological feasibility.

F. Compliance Costs and Cost Savings

Introduction
    This section presents OSHA's estimates of the costs and cost 
savings expected to result from the proposed revisions to the HCS. The 
estimated costs and cost savings are based on employers achieving full 
compliance with the new requirements of the proposed rule. They do not 
include prior costs and cost savings associated with firms whose 
current practices are already in compliance with the proposed 
requirements (where prior compliance is possible).
    The estimated costs and cost savings resulting from the proposed 
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 proposed changes to appendix B) and to 
conform to language criteria in precautionary statements and other 
mandatory language (per proposed changes to appendices C and D); (2) 
the cost of management familiarization and other management-related 
costs (associated with all of the proposed revisions to the standard); 
(3) the cost of training employees as necessitated by the proposed 
changes to the HCS (see existing 29 CFR 1910.1200(h)(1)); (4) the cost 
savings due to the new released-for-shipment provision (proposed 
revisions to 29 CFR 1910.1200(f)(11)); and (5) the cost savings from 
limiting labeling requirements for certain very small containers 
(proposed 29 CFR 1910.1200(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. Although OSHA has 
preliminarily determined that these are the only elements of the 
proposed revisions to the HCS that are expected to result in more than 
de minimis costs or cost savings, OSHA requests comments on whether any 
other proposed changes to the standard could cause employers to incur 
costs or obtain cost savings.
    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. OSHA expects that such effects, if any, will not be 
significant, but the agency would welcome input from stakeholders. This 
is consistent with the determination OSHA made with regard to 
reclassification costs for the 2012 final rule (77 FR 17625).
    In order to present compliance costs and cost savings on a 
consistent and comparable basis across various regulatory activities, 
they are expressed in annualized terms. Annualized costs and cost 
savings represent the most appropriate measure for assessing the 
longer-term potential impacts of this proposed 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 PEA (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.\28\ The 
economic effects

[[Page 9631]]

using a three percent discount rate are also provided in the Excel 
spreadsheets that support this PEA, which are contained in the docket 
(OSHA, 2020, Document ID 0049).
---------------------------------------------------------------------------

    \28\ OSHA annualized costs for this proposed rule over a 10-year 
period in accordance with Executive Order 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 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 proposed 
rule does not have any lengthy phase-in provisions, supporting 
OSHA's decision to use a 10-year annualization period for this PEA.
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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 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 PEA, in addition to applying fringe 
benefits to hourly (``base'') wages, OSHA also applied an overhead rate 
when estimating the marginal cost of labor in its primary cost 
calculation.
    Overhead costs are indirect expenses that cannot be tied to 
producing a specific product or service. Common examples include rent, 
utilities, and office equipment; however, there is no general consensus 
on the cost elements that fit the definition of overhead in the context 
of occupational safety and health. The lack of a common definition has 
led to a wide range of overhead estimates. Consequently, the treatment 
of overhead costs needs to be case-specific. For this PEA, OSHA has 
adopted an overhead rate of 17 percent of base wages, which is 
consistent with the overhead rate and methodology used for (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 (Nov. 24, 2017)); and (2) the FEA in support of OSHA's 
2016 final standard on Occupational Exposure to Respirable Crystalline 
Silica (81 FR 16285, 16488-16492 (March 25, 2016)).\29\
---------------------------------------------------------------------------

    \29\ This methodology was modeled after an approach used by the 
Environmental Protection Agency. 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 (Ex. 2066) (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 (Ex. 2065) (Document ID 0048).
---------------------------------------------------------------------------

    To calculate the total labor cost for an occupational category, 
OSHA added together three components: Base wage + fringe benefits 
(derived as 45.8 percent of the base wage) \30\ + applicable overhead 
costs (derived as 17 percent of the base wage). For example, the median 
hourly wage of an Occupational Health and Safety Specialist is $35.63. 
Applying a fringe markup of 45.8 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 $ $58.00 ($35.63 x .458 = $16.32; $35.63 x 
0.17 = $6.11; $35.63 + $16.32 + $6.11 = $58.00). Note that, for this 
labor category, the fringe markup is equal to 28.13 percent of the 
fully-loaded hourly wage and that the overhead rate is equal to 10.53 
percent of the fully-loaded hourly wage. Using this methodology, OSHA 
calculated the fully-loaded labor cost for four occupational 
categories: (1) Manager, Standard Occupational Classification (SOC) 
code 11-0000, $82.70; (2) Logistics Personnel, SOC code 13-1081, 
$58.51; (3) Production Worker, SOC code 51-0000, $28.18; and (4) 
Occupational Health and Safety Specialist, SOC code 19-5011, $58.00. 
(For further details, see Document ID 0049, tab ``Wages''.)
---------------------------------------------------------------------------

    \30\ In June of 2019, BLS reported: ``Employer costs for 
employee compensation for civilian workers averaged $36.77 per hour 
worked in March 2019 . . . Wages and salaries cost employers $25.22 
while benefit costs were $11.55.'' The fringe markup of 31.4 percent 
of total compensation ($11.55/$36.77) is equivalent to a benefits 
markup of 45.8 percent in relation to the base wage ($11.55/$25.22). 
(BLS, 2019, Document ID 0224).
---------------------------------------------------------------------------

    Table VII-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 2019 dollars. As shown in Table VII-12, 
the total annualized net cost savings of compliance with the proposed 
rulemaking is estimated to be $26.8 million--consisting of about $4.4 
million of annualized costs and $31.1 million of annual cost savings. 
Note that where tables in this PEA report estimated annualized costs, 
as in Table VII-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 VII-12, most of the estimated compliance costs and cost savings 
associated with the proposed rule would be incurred or realized by the 
chemical manufacturing industry and its distributors. However, the 
table also shows that familiarization costs would 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.
    OSHA expects that all compliance costs would be incurred in the 
first year, as the proposed rule would incorporate a one-year 
transition period into the compliance schedule for the standard. 
Specifically, for purposes of estimating the annualized compliance 
costs, OSHA assumed that the compliance costs associated with chemical 
reclassification, employee training, and management familiarization 
would be incurred in the first year following the effective date of the 
proposed revisions to the HCS.
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BILLING CODE 4510-26-C
Estimation of Compliance Costs and Cost Savings
    The remainder of his section explains how OSHA calculated the 
estimated compliance costs and cost savings arising from the proposed 
rule by describing the data and methodology used.
    The major elements of the proposed 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 proposed changes to appendix B) and to conform 
to language criteria in precautionary statements and other mandatory 
language (per proposed 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 proposed revisions to the standard); (3) the cost of training 
employees as necessitated by the proposed changes to the HCS (see 
existing 29 CFR 1910.1200(h)(1)); (4) cost savings from the new 
released-for-shipment provision (proposed revisions to 29 CFR 
1910.1200(f)(11)); and (5) cost savings from limiting labeling 
requirements for certain very small containers (proposed 29 CFR 
1910.1200(f)(12)).
    The estimated compliance costs and cost savings presented in this 
analysis of the proposed 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 
proposed 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 proposed revision to the standard 
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, Revisions to 
SDSs and Labels Due to Revised Precautionary Statements.
Costs Associated With Reclassifications and Revisions to Safety Data 
Sheets and Labels
    The proposed 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 proposed rule 
would 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). Revisions 
to SDSs and labels would be required under provisions in the existing 
HCS, which require chemical manufacturers and importers to update SDSs 
and labels within three months and six months, respectively, of 
becoming aware of significant new information regarding the hazards of 
the chemicals they produce or import (see 29 CFR 1910.1200(f)(11), 
(g)(5)).
    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 77 FR 17634-17637 in the FEA 
of the 2012 final rule for a discussion of factors that compel 
employers to update SDSs and labels voluntarily). The proposed rule 
would require limited changes to some SDSs and labels. Given the phase-
in period for the proposed changes to the standard,\31\ OSHA expects 
that chemical manufacturers and importers would be able to phase in 
revisions to their labels and SDSs in accordance with the normal cycle 
of change, and therefore would not need to replace existing labels or 
SDSs. OSHA requests comments on this preliminary assumption.
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    \31\ OSHA proposes that the revisions become effective 60 days 
after publication (paragraph (j)(1)) and that chemical 
manufacturers, importers, and distributors evaluating substances 
comply with all modified provisions within one year after the 
effective date (paragraph (j)(2)). OSHA also proposes that chemical 
manufacturers, importers, and distributors evaluating mixtures 
comply with all modified provisions within two years after the 
effective date (paragraph (j)(3)).
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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 proposed 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 would be incurred 
to achieve compliance with the proposed rule. These estimated costs, 
shown below in Tables VII-13 and VII-14, would be in addition to the 
costs that already need to be incurred to comply with applicable 
requirements of the existing HCS and represent the time it would 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 have an obligation, under 
the existing HCS, to ensure that the information provided in their SDSs 
and labels is accurate and current (29 CFR 1910.1200(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 (29 CFR 1910.1200(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 existing HCS, to review the available hazard information (29 
CFR 1910.1200(d)(2)), to classify the chemical in accordance with 
applicable hazard criteria (29 CFR 1910.1200(d)(1)), and to develop 
corresponding SDSs (29 CFR 1910.1200(g)) and labels (29 CFR 
1910.1200(f)). OSHA is not estimating costs for activities already 
required; rather, the agency is estimating costs for activities that 
would 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).

[[Page 9637]]

Revisions to SDSs and Labels Due to Chemical Reclassification
    The NAICS industries listed in Columns 1 and 2 of Table VII-13 are 
those that OSHA expects would manufacture aerosols, desensitized 
explosives, or flammable gases. Of course, not all chemicals covered in 
these NAICS industries are aerosols, desensitized explosives, or 
flammable gases. Column 3 of Table VII-13 reflects OSHA's judgment 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) in these NAICS industries would be affected by the proposed 
requirements for aerosols, desensitized explosives, and flammable 
gases. OSHA invites public comments on its preliminary projection that 
50 percent of the electronic files for SDSs and labels would be 
affected in these industries.
BILLING CODE 4510-26-P

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    OSHA derived the number of directly affected electronic files for 
SDSs and labels in Column 4 of Table VII-13 by applying the 50 percent 
factor to the overall number of affected SDSs (electronic files) from 
Table VII-5. For

[[Page 9641]]

example, in NAICS 211130, Table VII-5 shows the overall number of 
affected SDSs (technically, the number of electronic files) is 15,810. 
Applying a factor of 50 percent, OSHA estimated that 7,905 SDSs 
(electronic files) would be directly affected by the reclassification 
provision (see Table VII-13, NAICS 211130 within the section ``Total/
Average''). All of the estimates of directly affected SDSs (electronic 
files) presented in Table VII-13 are similarly derived from Table VII-
5, but only those NAICS industries with affected SDSs (electronic 
files) are reported in Table VII-13.
    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 VII-5 of this PEA). OSHA expects 
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 is OSHA's understanding that this has been the practice 
for decades.
    Table VII-13 also contains estimates of the amount of time OSHA 
expects it will take to update electronic files for SDSs and labels 
under the proposed revisions to the standard. OSHA believes that the 
estimates provided in Table VII-13 are reasonable because they reflect 
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 believes that the estimated time to update SDSs and 
labels (electronic files) used in this analysis represents 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 currently being proposed 
are significantly more limited in scope than the 2012 final rule, with 
fewer affected hazard categories and more limited changes; however, the 
proposed revisions to the standard still present opportunities for 
scale efficiencies in reclassification. As a result, OSHA estimates 
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).\32\ At a loaded hourly 
wage (including overhead) of $58.00 for a Health and Safety Specialist, 
this would result in unit costs 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 yields 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 7 percent 
discount rate over a 10-year period results in estimated annualized 
costs of approximately $915,095 for reclassification in accordance with 
the criteria specified in the proposed revisions to the HCS. OSHA 
invites interested parties to comment on these cost estimates and the 
assumptions underlying them.
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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 proposed rule; 
the current HCS does not allow SDSs or labels to display chemical 
classifications that are not in conformance with the current rule.
---------------------------------------------------------------------------

Revisions to SDSs and Labels Due to Revised Precautionary Statements, 
etc.
    The proposed revisions to the HCS would 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 proposed 
changes to the standard, affected establishments would have to 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 
existing 29 CFR 1910.1200(f) and (g)). The modification of SDSs and 
labels under the revisions proposed in appendices C and D would involve 
conforming to formatting and language standards, but would not require 
any additional 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 proposed changes to the appendices would 
require only limited changes to the electronic content of SDSs and 
labels, and, as explained previously, OSHA expects that the phase-in 
period for the proposed changes to the standard would 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 would not be necessary to replace existing labels or 
SDSs.\34\ OSHA requests comments on this preliminary assumption.
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    \33\ See discussion in the 2012 preamble (77 FR 17634).
    \34\ OSHA proposes that the revisions become effective 60 days 
after publication (paragraph (j)(1)) and that chemical 
manufacturers, importers, and distributors evaluating substances 
comply with all modified provisions within one year after the 
effective date (paragraph (j)(2)). OSHA also proposes that chemical 
manufacturers, importers, and distributors evaluating mixtures 
comply with all modified provisions within two years after the 
effective date (paragraph (j)(3)).
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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 
proposed revisions to appendices C and D represent the incremental 
costs that would be incurred to achieve compliance with the proposed 
changes to the appendices. These estimated costs, shown below in Table 
VII-14, would be in addition to the costs that are already incurred to 
comply with applicable requirements of the existing HCS.

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BILLING CODE 4510-26-C
    Table VII-14 shows the estimated costs associated with 
modifications to electronic templates for SDSs and labels to conform to 
formatting and language

[[Page 9651]]

criteria in precautionary statements and other mandatory language 
specified in the proposed revisions to appendices C and D by NAICS 
industry and establishment size. The NAICS industries listed in Columns 
1 and 2 of Table VII-14 are those that OSHA expects would need to 
update SDSs and labels under the proposed 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 proposed 
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 VII-5, 
VII-6, and VII-7.\35\
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    \35\ As described above in the discussion explaining Table VI-5, 
OSHA's estimate of the total number of SDSs per NAICS industry was 
developed to support the agency's FEA for the 2012 final standard. 
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 revisions to the HCS using a 
sampling of company websites and the SDSs posted there. (ERG, 2012, 
Document ID 0029). 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). Although OSHA has preliminarily determined that this 
methodology remains sound, the agency invites public comment on the 
reasonableness of this methodology for the current analysis.
---------------------------------------------------------------------------

    OSHA estimates 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 3 to 7 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.\36\ As shown in 
Column 4 of Table VII-14, OSHA estimates 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. Multiplying these 
labor burdens by the loaded hourly wage of $58.00 results in unit costs 
for Health and Safety Specialists of $40.60, $29.00, and $17.40 per SDS 
for small, medium, and large establishments, respectively.
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    \36\ 36 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, 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.\37\ 
These baseline compliance rates are the same ones OSHA used in the 2012 
FEA (77 FR 17636).
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    \37\ 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,\38\ results in an estimated total one-
time cost associated with revising SDSs and labels to conform to the 
proposed appendix language on precautionary statements and other 
mandatory language. As shown in Column 7 of Table VII-14, this total 
one-time cost is estimated to be about $18.4 million. Annualizing this 
one-time cost using a 7 percent discount rate over a 10-year period 
results in estimated annualized costs of approximately $2.6 million for 
affected employers to revise SDSs and labels to comply with the 
proposed revisions to appendices C and D. OSHA invites interested 
parties to provide comments on these cost estimates and the assumptions 
underlying them.
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    \38\ 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.
---------------------------------------------------------------------------

    The estimates of total costs in Table VII-14 are included within a 
broader cost category shown earlier in the aggregate costs presented in 
Table VII-12. Column 5 of Table VII-12 displays, by NAICS code, the 
combined annualized cost estimates for reclassifying chemicals (from 
Table VII-13) and revising SDSs and labels to be consistent with the 
precautionary statements and other language specified in the proposed 
revisions to the mandatory appendices (from Table VII-14).
Management Familiarization and Other Management-Related Costs
    In order to implement the proposed 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 would need to 
become familiar with the updates OSHA is making as part of this 
rulemaking. The nature and extent of the familiarization required would 
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.\39\ This proposed rule would require some 
changes to hazard communication programs in affected establishments, 
but those changes would be significantly less extensive than those 
required by the 2012 rule. Therefore, OSHA believes that much less time 
would be needed for familiarization and implementation under this 
proposed rule than was necessary under the 2012 rule.
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    \39\ Larger employers were estimated to have greater 
familiarization costs for the 2012 HCS final rule because they have 
more managers.
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    For the present proposed rule, OSHA estimates that management 
familiarization time would vary by establishment size. It would also 
vary depending on whether an establishment would simply be 
familiarizing itself with the proposed rule or would also need to take 
further action because it would be affected by one or more of the 
proposed changes to the standard. Above in Section VII.C Profile of 
Affected Industries, Establishments, and Employees, Table VII-10 
presents, by NAICS industry, the percentage of establishments (and for 
training,

[[Page 9652]]

entities) expected to be affected by rule familiarization and whether 
those establishments or entities would incur additional costs or no 
additional costs--that is, whether those establishments or entities 
would or would not incur additional costs for revising SDSs/labels or 
for training employees as a result of the proposed rule.\40\ In terms 
of manufacturing establishments that would have costs in addition to 
management familiarization costs resulting from the provisions of the 
proposed rule, OSHA estimates 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 resulting from the provisions of this proposed 
rule, OSHA estimates that there are 79,500 small establishments, 22,657 
medium establishments, and 467 large establishments; their only costs 
associated with this proposal would be as a result of rule 
familiarization.\41\
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    \40\ 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.
    \41\ Note that the numbers of small, medium, and large 
establishments reported above are derived in the ``Rule Fam'' tab of 
the OSHA spreadsheet in support of this proposed rule (see Document 
ID 0049).
---------------------------------------------------------------------------

    To estimate unit costs, OSHA 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. For this PEA, 
because the new requirements found within this proposed standard would 
be significantly less extensive than those required by the 2012 rule, 
OSHA expects 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 requests public 
comment on the agency's preliminary assumptions for estimating the cost 
of management familiarization.
    For small establishments, OSHA estimated management familiarization 
costs of 0.5 hours of a Health and Safety Specialist's labor time. For 
medium establishments, OSHA estimated 2 hours of a Health and Safety 
Specialist's labor time. For large establishments, OSHA estimated 8 
hours of a Health and Safety Specialist's labor time. Multiplying these 
labor burdens by the loaded hourly wage of $58.00 results in estimated 
management familiarization costs per establishment of $29.00, $116.01, 
and $464.04 for small, medium, and large establishments, respectively.
    For establishments that would not incur other costs as a result of 
the proposed rule, OSHA estimates that rule familiarization will take 
half as long; 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. 
Therefore, OSHA adopted estimates of 0.25 hours, 1 hour, and 4 hours of 
a Health and Safety Specialist's labor time for small, medium, and 
large establishments, respectively. Multiplying these labor burdens by 
the loaded hourly wage of $58.00 results in management familiarization 
costs per establishment of $14.50 for small establishments, $58.00 for 
medium establishments, and $232.02 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 $5.2 million. Annualizing this one-time cost 
using a 7 percent discount rate over a 10-year period results in an 
estimate of annualized costs of $735,894. Table VII-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 VII-12. OSHA 
invites interested parties to provide comments on these cost estimates 
and the assumptions underlying them.

   Table VII-15--Total Costs Associated With Management Familiarization With the Proposed Revisions to the HCS
                                     [by establishments size, 2019 dollars]
----------------------------------------------------------------------------------------------------------------
                                              Small               Medium               Large
                                          establishments   establishments (20-  establishments (>=
                                         (<20 employees)      499 employees)      500 employees)        Total
                                             affected            affected            affected
----------------------------------------------------------------------------------------------------------------
Directly Affected Establishments
    Total Establishments..............             38,018               11,273                 394        49,685
    Wage..............................             $58.00               $58.00              $58.00  ............
    Hours.............................               0.50                 2.00                8.00  ............
    Unit Cost Per Establishment.......             $29.00              $116.01             $464.04  ............
    Total One-Time Cost...............         $1,102,609           $1,307,771            $182,830    $2,593,210
                                       -------------------------------------------------------------------------
        Total Annualized Cost (7%)....           $156,987             $186,197             $26,031      $369,215
----------------------------------------------------------------------------------------------------------------
Indirectly Affected Establishments
    Total Establishments..............             79,500               22,657                 467       102,624
    Wage..............................             $58.00               $58.00              $58.00  ............
    Hours.............................               0.25                 1.00                4.00  ............
    Unit Cost Per Establishment.......             $14.50               $58.00             $232.02  ............
    Total One-Time Cost...............         $1,152,841           $1,314,209            $108,353    $2,575,403
                                       -------------------------------------------------------------------------
        Total Annualized Cost (7%)....           $164,139             $187,114             $15,427      $366,679
----------------------------------------------------------------------------------------------------------------
Total
    Total Establishments..............            117,518               33,930                 861       152,309
    Total One-Time Cost...............         $2,255,450           $2,621,980            $291,183    $5,168,613
                                       -------------------------------------------------------------------------
        Total Annualized Cost (7%)....           $321,125             $373,311             $41,458      $735,894
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.

[[Page 9653]]

 
Note: Figures may not add to totals due to rounding.

Costs Associated With Training Employees
    For this preliminary economic analysis, OSHA estimated the 
incremental costs to train chemical production employees who are 
covered by, and are already trained in accordance with, the existing 
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.\42\ This analysis is 
described below. OSHA is not estimating any training costs for users of 
aerosols, desensitized explosives, or flammable gases in the workplace. 
OSHA 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 
would change under the proposed 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. At most, such users might 
require notification of a change in the classification of those 
chemicals.
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    \42\ OSHA has preliminarily concluded that these would be the 
only training costs associated with the proposed revisions to the 
HCS. The agency requests comments on this determination.
---------------------------------------------------------------------------

    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.
    OSHA considered whether some increase in user training might be 
required for non-flammable aerosols not under pressure, since a small 
portion of these may not currently be classified as either flammable 
aerosols or gas under pressure; as noted in the Summary and Explanation 
section for appendix B, 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 non-
flammable aerosols not under pressure are fairly uncommon and, 
therefore, OSHA has preliminarily concluded that the total user 
training time required for non-flammable aerosols not under pressure 
would also be negligible. The agency requests comments on its 
preliminary conclusions regarding training time for users of 
reclassified chemicals.
    As discussed above, under the proposed revisions to the HCS, some 
chemical production employees who are covered by, and are already 
trained in accordance with, the existing standard would 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.
    OSHA estimates that each affected chemical manufacturing firm \43\ 
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 the labor burden for each labor 
category by the loaded hourly wages of $58.00 for a Health and Safety 
Specialist, $58.51 for logistics personnel, and $28.18 for production 
workers, results in unit costs of $145.01, $11.70, and $5.64, 
respectively.
---------------------------------------------------------------------------

    \43\ OSHA anticipates that, in practice, training would be 
organized more efficiently at the corporate (firm) level than at the 
establishment level.
---------------------------------------------------------------------------

    Multiplying these unit costs by the 2,754 affected firms, 1,179 
affected logistics managers, and 76,447 affected production workers 
yields an undiscounted estimated one-time cost of $843,940.\44\ 
Annualizing this one-time cost using a 7 percent discount rate over a 
10-year period results in estimated annualized costs of $120,158. The 
unit values that factored into OSHA's estimate of training costs are 
shown in Table VII-16. The distribution of these training costs by 
NAICS code is displayed in Column 4 of Table VII-12. OSHA invites 
interested parties to provide comments on these cost estimates and the 
assumptions underlying them.
---------------------------------------------------------------------------

    \44\ The estimated number of affected firms, logistics managers 
and production workers are derived in Document ID 0049, tab 
``Training''. The affected number of firms (2,754) 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).

             Table VII-16--Training Costs Associated With the Proposed Revisions to the HCS Standard
                                                 [2019 Dollars]
----------------------------------------------------------------------------------------------------------------
                                         Health & safety
                                         specialist hours  Logistics personnel   Production worker
                                           per firm to      hours per emp. to    hours per emp. to      Total
                                         prepare training    receive training    receive training
----------------------------------------------------------------------------------------------------------------
Affected Firms........................              2,754  ...................  ..................         2,754
Employees Needing Training............  .................                1,179              76,447        78,489
Wage..................................             $58.00               $58.51              $28.18  ............
Hours.................................                2.5                  0.2                 0.2           2.9
Unit Cost.............................            $145.01               $11.70               $5.64       $162.35
Total One-Time Cost...................           $399,289              $13,796            $430,855      $843,940
                                       -------------------------------------------------------------------------
    Total Annualized Cost (7%)........            $56,850               $1,964             $61,344      $120,158
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.
Note: Figures may not add to totals due to rounding.

[[Page 9654]]

Released for Shipment
    In paragraph (f)(11) of the current 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. OSHA proposes 
to modify paragraph (f)(11) such that chemicals that have been released 
for shipment and are awaiting future distribution need not be 
relabeled; however, the manufacturer or importer must provide an 
updated label for each individual container with each shipment.
    OSHA anticipates 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. In Columns 1 and 2 of 
Table VII-17, OSHA has identified the six industries (four 
manufacturing and two wholesale) that it expects would be impacted by 
the proposed modifications to paragraph (f)(11).\45\ These are 
primarily fertilizer manufacturers, paint manufacturers, and 
wholesalers of related farm and paint supplies. OSHA invites 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 has 
not considered in this proposal.
---------------------------------------------------------------------------

    \45\ In principle, pesticide manufacturers would also be 
affected by the proposed revision to the standard, but pesticide 
labeling in the United States is covered by the U.S. Environmental 
Protection Agency under the Federal Insecticide, Fungicide, and 
Rodenticide Act (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.
---------------------------------------------------------------------------

    The first factor used to estimate the cost savings resulting from 
the proposed changes to paragraph (f)(11) is 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.\46\ 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 (CPDA, 
2017, pp. 4-5, Document ID 0006).
---------------------------------------------------------------------------

    \46\ Email to Maureen Ruskin of OSHA Re: Comments Supplementing 
a Petition Submitted to OSHA on May 24, 2016 Requesting a Revision 
of Paragraph (f)(11) of 29 CFR 1910.1200 (CPDA, 2017, Document ID 
0006).
---------------------------------------------------------------------------

    For OSHA's purposes, the critical costing information from CPDA is 
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 (CPDA, 2017, p. 8, Document ID 0006). 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. 
Furthermore, with an effective range of labeling costs from 1.5 percent 
to 100 percent of the value of the product, OSHA estimates, 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 has 
assumed that this same estimate would also apply to relabeling paints 
and related chemical products in distribution. The agency invites 
comments on this assumption.
    The 50 percent average cost savings estimate would apply only to 
those products requiring relabeling. In order to estimate the expected 
cost savings for all products in the NAICS codes affected by the 
proposed revisions to paragraph (f)(11), OSHA also needs 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 be relabeled in any 
particular year due to a manufacturer-initiated labeling change; \47\ 
and (3) the percentage of all products in the NAICS industries that are 
covered by this proposed rule.
---------------------------------------------------------------------------

    \47\ These labeling changes occur when the manufacturer becomes 
newly aware of significant information regarding the hazards of a 
chemical. See existing 29 CFR 1910.1200(f)(11).
---------------------------------------------------------------------------

    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 five percent of the 
products in the six NAICS industries potentially impacted by the 
proposed modifications to paragraph (f)(11) would be warehoused for 
more than six months. For (2) above, OSHA anticipates that 
manufacturer-initiated relabeling would be rare, and estimated that 
only one percent of products warehoused for more than six months would 
be relabeled in any particular year due to a manufacturer-initiated 
labeling change to one or more of its chemical ingredients. See 
existing 29 CFR 1910.1200(f)(11). OSHA invites comments on these 
estimates.
    For factor (3) above, OSHA assumed that 100 percent of the products 
in the four NAICS manufacturing industries are covered by the HCS.\48\ 
For the two wholesale industries, however, some 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

[[Page 9655]]

supplies are non-fertilizers, such as grains (e.g., alfalfa, hay, 
livestock feeds) and nursery stock (e.g., plant seeds and plant bulbs). 
Based on data from the 2012 Economic Census,\49\ 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 ``RF 
Shipment''). OSHA used ERG's estimates to develop the expected cost 
savings attributable to the proposed revisions to paragraph (f)(11). 
The agency invites comments on these estimates.\50\
---------------------------------------------------------------------------

    \48\ A review of the products covered under the manufacturing 
NAICS codes reveals they are all, or almost all, chemicals.
    \49\ 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).
    \50\ Under the proposed 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. The agency estimates that any incremental costs 
associated with providing updated labels are likely to be 
negligible, as OSHA believes this is already standard industry 
practice.
---------------------------------------------------------------------------

    Column 3 of Table VII-18 shows the average product value (revenue) 
for each of the six NAICS industries that OSHA expects would be 
affected by the proposed modification to paragraph (f)(11).\51\ Column 
4 of Table VII-18 shows the number of affected firms (entities) for 
each of these six NAICS industries.\52\ Column 5 of Table VII-18 shows 
the estimated loss avoided due to the proposed 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 would be warehoused for 
more than six months; (3) the percentage of products warehoused for 
more than six months that would require relabeling in any particular 
year due to a manufacturer-initiated labeling change; and (4) the 
percentage of all products in the NAICS industries covered by this 
proposed rule.
---------------------------------------------------------------------------

    \51\ Derived for each NAICS by dividing Column 3 of Table VII-9 
(total industry revenues) by Column 7 of Table VII-1 (number of 
affected firms).
    \52\ Obtained from Column 7 of Table VII-1.
---------------------------------------------------------------------------

    Table VII-17 presents, by NAICS industry, these four factors and 
the calculated percentage loss in revenue OSHA anticipates would be 
avoided under the proposed released-for-shipment provision.

                      Table VII-17--Calculation of the Percentage Loss Avoided Due to the Proposed Released-for-Shipment Provision
                                                                     [2019 Dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                      Percentage of
                                                                                     Percentage of       products       Percentage of
                                                                        Percentage      products      warehoused >=   products covered     Product of
               NAICS                          NAICS industry               cost      warehoused >=    six months and   by the proposed     percentages
                                                                         savings       six months        require            rule
                                                                                                        relabeling
                                                                               (A)              (B)              (C)               (D)    (A), (B), (C),
                                                                                                                                                 and (D)
--------------------------------------------------------------------------------------------------------------------------------------------------------
325311............................  Nitrogenous Fertilizer                      50                5                1               100              0.03
                                     Manufacturing.
325312............................  Phosphatic Fertilizer                       50                5                1               100              0.03
                                     Manufacturing.
325314............................  Fertilizer (Mixing Only)                    50                5                1               100              0.03
                                     Manufacturing.
325510............................  Paint and Coating Manufacturing..           50                5                1               100              0.03
424910............................  Farm Supplies Merchant                      50                5                1             41.70              0.01
                                     Wholesalers.
424950............................  Paint, Varnish, and Supplies                50                5                1             77.60              0.02
                                     Merchant Wholesalers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.

    The estimated cost savings for each of the six affected industries 
arising from the proposed modifications to paragraph (f)(11) then is 
simply the product of Columns 3, 4, and 5 in Table VII-18. Summing the 
cost savings for each of the six industries yields an estimated annual 
cost savings of $29.8 million. OSHA requests comments on the 
reasonableness of this estimate and the assumptions underlying it 
(including the various factor percentage estimates listed in Table VII-
17).

             Table VII-18--Cost Savings Associated With the Proposed Released-for-Shipment Provision
                                                 [2019 Dollars]
----------------------------------------------------------------------------------------------------------------
                                                      Average                      Loss avoided
          NAICS               NAICS industry       product value  Affected firms     as a % of     Loss avoided
                                                     (revenue)                        revenue
----------------------------------------------------------------------------------------------------------------
325311..................  Nitrogenous Fertilizer     $37,902,969             163            0.03      $1,544,546
                           Manufacturing.
325312..................  Phosphatic Fertilizer      127,231,784              45            0.03       1,431,358
                           Manufacturing.
325314..................  Fertilizer (Mixing          13,737,854             359            0.03       1,232,972
                           Only) Manufacturing.
325510..................  Paint and Coating           28,813,229             998            0.03       7,188,901
                           Manufacturing.
424910..................  Farm Supplies Merchant      28,809,209           4,965            0.01      14,911,683
                           Wholesalers.
424950..................  Paint, Varnish, and         18,022,834           1,012            0.02       3,538,387
                           Supplies Merchant
                           Wholesalers.
                                                 ---------------------------------------------------------------

[[Page 9656]]

 
    Total...............  ......................  ..............           7,542  ..............      29,847,846
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.
Note: Figures may not add to totals due to rounding.

Labels on Very Small Containers
    Proposed paragraph (f)(12), which addresses the labeling of small 
containers, would limit 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 proposed 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 PEA. As proposed 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 PEA--if 
they can demonstrate that any label would interfere with the normal use 
of the container.
    Following publication of the 2012 updates to the HCS, stakeholders 
requested that OSHA clarify its enforcement policy on labels for small 
containers. In response, through letters of interpretation, OSHA 
adopted practical accommodations that specified: (1) The minimum 
information required for a label on the immediate container of the 
shipped chemical; and (2) the minimum information required for the 
outer packaging of shipped small containers (see, e.g., Collatz, 2015, 
Document ID 0174; Watters, 2013, Document ID 0200; Blankfield, 2017, 
Document ID 0170). Proposed paragraph (f)(12)(ii) would incorporate 
into the HCS the accommodations for small containers described in these 
letters of interpretation; however, the letters did not contain any 
guidance unique to very small containers, which would be covered by 
proposed paragraph (f)(12)(iii).
    For costing purposes, OSHA estimates that no cost savings will 
arise from proposed paragraph (f)(12)(ii) (small containers); OSHA 
expects that employers are already benefitting from the practical 
accommodations on the labeling of small packages described in the 
aforementioned letters of interpretation. OSHA invites public comments 
on this preliminary determination and the magnitude of any cost savings 
that should be attributed to proposed paragraph (f)(12)(ii).
    OSHA has 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 has 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 Column 3 of Table VII-19, OSHA 
estimates that there are approximately 63.5 million labels on very 
small containers in these six 6-digit NAICS manufacturing industries 
that OSHA anticipates could be affected by this part of the proposed 
rule.\53\
---------------------------------------------------------------------------

    \53\ The number of very small containers in Column 3 of Table 
VII-19 for each of these six NAICS industries was obtained from 
Column 4 of Table VII-5.
---------------------------------------------------------------------------

    Even in these six NAICS industries, however, 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 estimates 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 VII-19 and, equivalently, Column 7 
of Table VII-5).
    Manufacturers with containers falling under proposed 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). OSHA estimates an 
incremental unit cost savings of $0.051 per label for very small 
containers.\54\ That unit cost savings is 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 proposed paragraph 
(f)(12)(iv)(A). As shown in Table VII-19, multiplying the number of 
affected labels by the unit cost savings of $0.051 per label for very

[[Page 9657]]

small containers yields estimated annual cost savings of $1.3 million. 
OSHA invites interested parties to provide comments on these cost 
estimates and the assumptions underlying them.
---------------------------------------------------------------------------

    \54\ The Flavor and Extract Manufacturers Association of the 
United States (FEMA) provided OSHA (in a letter to Robert Stone of 
OSHA, 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). OSHA believes it is likely that most 
of the cost savings reported from the FEMA survey would be 
attributable to the expensive types of labels.
    Based on the unit cost data provided by FEMA, 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 derived an estimate of 
$0.05087 in cost savings per label (with the unrounded estimate used 
in the analysis).

   Table VII-19--Estimated Cost Savings Associated With Abbreviated Labels on Very Small Containers Under the
                                              Proposed HCS Standard
                                                 [2019 Dollars]
----------------------------------------------------------------------------------------------------------------
                                                   Labels-- very   Percentage of
          NAICS               NAICS industry           small        labels with    Labels w/cost    Annual cost
                                                    containers     cost savings       savings         savings
----------------------------------------------------------------------------------------------------------------
325180..................  Other Basic Inorganic       14,768,423              40       5,907,369        $300,518
                           Chemical
                           Manufacturing.
325199..................  All Other Basic             35,524,371              40      14,209,748         722,874
                           Organic Chemical
                           Manufacturing.
325411..................  Medicinal and                5,106,176              40       2,042,471         103,904
                           Botanical
                           Manufacturing.
325412..................  Pharmaceutical               6,471,452              40       2,588,581         131,685
                           Preparation
                           Manufacturing.
325413..................  In-Vitro Diagnostic            501,664              40         200,665          10,208
                           Substance
                           Manufacturing.
325414..................  Biological Product           1,113,080              40         445,232          22,650
                           (except Diagnostic)
                           Manufacturing.
                                                 ---------------------------------------------------------------
    Total...............  ......................      63,485,165              40      25,394,066       1,291,839
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.
Note: Figures may not add to totals due to rounding.

Sensitivity Analysis
    In this section, OSHA presents the results of a sensitivity 
analysis to demonstrate how robust the estimates of net cost savings 
are to changes in various cost parameters. In this analysis, OSHA made 
a series of isolated changes to individual cost input parameters in 
order to determine their effects on the agency's estimates of 
annualized net cost savings, with a seven-percent discount rate as the 
reference point. The agency has conducted these calculations for 
informational purposes only.
    The methodology and calculations underlying the cost estimates 
associated with this rulemaking are generally linear and additive in 
nature. Thus, the sensitivity of the results and conclusions of the 
analysis will generally be proportional to isolated variations in a 
particular input parameter. For example, if the estimated time that 
employees will need to devote to attending new training doubles, the 
corresponding labor costs would double as well.
    OSHA evaluated a series of such changes in input parameters to test 
whether and to what extent the general conclusions of the preliminary 
economic analysis 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 VII-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 proposed 
released-for-shipment provision. Table VII-20 shows that the estimated 
net cost savings from the proposed rule would decline by $14.9 million 
annually, from $26.8 million to $11.8 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 proposed released-for-shipment provision. Table VII-20 shows that 
the estimated net cost savings from the proposed rule would increase by 
$29.8 million annually, from $26.8 million to $56.6 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 proposed paragraph (f)(12). As shown in Table VII-20, if OSHA's 
estimates of other input parameters remained unchanged, the estimated 
net cost savings from the proposed rule would decline by $0.6 million 
annually, from $26.8 million to $26.1 million annually, or by about 2 
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 proposal, i.e., OSHA did not 
reduce estimated familiarization time for firms that are not affected 
by other parts of the proposal. The effect of this change would be to 
raise compliance costs for 102,624 establishments in manufacturing and 
wholesale trade; the estimated net cost savings from the proposed rule 
would be reduced by $0.4 million annually, from $26.8 million to $26.4 
million annually, or by about 1 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 VII-13 and VII-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 $3.5 million annually, 
from $26.8 million to $23.2 million, or by 13.2 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 proposed rule would increase by $0.5 million annually, or by 
1.7 percent, resulting in a total estimate of annualized net cost 
savings of $27.2 million.

[[Page 9658]]

            Table VII-20--Sensitivity Tests and Regulatory Alternatives--Impacts on Net Cost Savings
                                     [7 Percent discount rate, 2019 dollars]
----------------------------------------------------------------------------------------------------------------
                                                                                    Percentage
     Uncertainty (cost) scenarios      Change from OSHA's best   Difference from   impact on net     Net cost
                                               estimate           proposed rule    cost savings       savings
----------------------------------------------------------------------------------------------------------------
Proposed Rule--OSHA's midpoint         N/A....................                $0             0.0     $26,753,711
 estimate.
Reduce from 1 percent to 0.5 percent   Halves cost savings          -$14,923,923           -55.8      11,829,788
 the percentage of products             associated with
 warehoused for more than six months    proposed released-for-
 that would require relabeling in any   shipment provision.
 particular year.
Increase from 1 percent to 2 percent   Doubles cost savings           29,847,846           111.6      56,601,557
 the percentage of products             associated with
 warehoused for more than six months    proposed released-for-
 that would require relabeling in any   shipment provision.
 particular year.
Reduce from 40% to 20% the percentage  Halves cost savings for          -645,919            -2.4      26,107,792
 of very small containers that would    affected firms.
 be affected by proposed paragraph
 (f)(12).
Rule familiarization time would not    Raises costs for the             -366,679            -1.4      26,387,032
 be reduced for firms that are not      31,577 establishments
 affected by any other cost             in NAICS 31-33--
 provisions; it would be identical to   Manufacturing, and the
 rule familiarization time for those    71,047 establishments
 that are affected by other             in NAICS 42--Wholesale
 provisions.                            Trade not affected by
                                        other provisions.
Doubles labor hours for the            Doubles labor costs for        -3,529,921           -13.2      23,223,790
 reclassification of chemicals and      the approximately 13
 compliance with the new mandatory      six-digit NAICS
 language in the appendices to the      industries affected by
 proposed standard.                     proposed changes to
                                        paragraph (d) and
                                        appendices B, C, and D.
Excludes overhead costs from fully     For the four job                  458,003             1.7      27,211,714
 loaded hourly wage rates.              categories in the cost
                                        model, overhead costs
                                        (17 percent of base
                                        wages) are not applied
                                        and estimated wage
                                        rates are
                                        correspondingly lower.
Remove the proposed provisions that    Eliminates cost savings        -1,291,839            -4.8      25,461,873
 result in cost savings for very        for affected employers.
 small labels.
Eliminate the proposed released-for-   Eliminates cost savings       -29,847,846          -111.6      -3,094,135
 shipment provisions and associated     for affected employers.
 cost savings.
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health (Document ID
  0049, tab ``Tables'').

    Not part of this table, but discussed in A. Introduction and 
Summary, the agency examined the effect of lowering the discount rate 
for annualizing costs from 7 percent to 3 percent. Lowering the 
discount rate to 3 percent would yield annualized net cost savings of 
$27.5 million, approximately $700,000 more in annual cost savings than 
the net cost savings at a 7 percent discount rate.
Regulatory Alternatives
    This section discusses two regulatory alternatives to the changes 
OSHA is proposing in this NPRM: (1) Removing the proposed 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 proposed 
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 VII-20, each regulatory alternative is described and analyzed 
relative to the proposed revisions to the HCS. Midpoint estimates are 
presented in all cases. Under Regulatory Alternative (1) (elimination 
of changes related to labeling of very small containers), cost impacts 
total $1.3 million (4.8 percent of baseline cost savings), resulting in 
a reduction of estimated annualized net cost savings to a total of 
$25.5 million. Under Regulatory Alternative (2) (elimination of changes 
related to labels on packages that have been released for shipment), 
cost impacts on employers total $29.8 million (112 percent of baseline 
cost savings), resulting in an overall estimate of annualized net costs 
of $3.1 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). The elimination of neither alternative, however, would alter 
the agency's determination of economic feasibility for the proposed 
revisions to the HCS as a whole. Nor would the elimination of these 
alternatives result in a significant impact on a substantial number of 
small entities (see Section VII. G. Economic Feasibility and Impacts).

G. Economic Feasibility and Impacts

    This section presents OSHA's analysis of the potential economic 
impacts of the proposed 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 Initial 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.

[[Page 9659]]

    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 (OSHA, 2016, Chapter VI, 
pp. VI-20/VI-23 and Table VI-3). \55\ Of course, OSHA recognizes that 
even when costs are within this range, there could be unusual 
circumstances requiring further analysis.
---------------------------------------------------------------------------

    \55\ Document ID OSHA-2010-0034-4247, Attachment ``Silica FEA 
Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility 
Determination'' (Document ID 0045).
---------------------------------------------------------------------------

    If, however, there is infinite price elasticity of demand, and all 
costs are absorbed by affected firms, the immediate impact of the rule 
would be observed in reduced industry profits. OSHA uses the ratio of 
annualized costs to annual profits as a second check on economic 
feasibility. In the absence of evidence to the contrary, OSHA generally 
considers a standard to be economically feasible for an industry when 
the annualized costs of compliance are less than a threshold level of 
ten percent of annual profits. This is a fairly modest threshold level, 
given that normal year-to-year variations in profit rates in an 
industry can exceed 40 percent or more (OSHA, 2016, Chapter VI, pp. VI-
20/VI-23 and Table VI-5).\56\
---------------------------------------------------------------------------

    \56\ Document ID OSHA-2010-0034-4247, Attachment ``Silica FEA 
Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility 
Determination'' (Document ID 0045).
---------------------------------------------------------------------------

    In order to assess the nature and magnitude of the economic impacts 
associated with compliance with the proposed rule, OSHA developed 
quantitative estimates of the potential economic impact of the 
requirements on each of the affected industry sectors. The estimated 
costs of compliance presented in Section VII.F of this preamble were 
compared with industry revenues and profits to provide a measure of 
potential economic impacts. Table VII-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 proposed revisions to the HCS is such that all 
affected firms would incur some costs, but only a small subset would 
derive the cost savings that are monetized in this PEA (although most 
or all would enjoy non-monetized benefits, e.g., in foreign trade). To 
examine the economic impacts of the proposed revisions to the standard 
for those affected establishments that obtain no monetized cost savings 
from any of the proposed revisions 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 VII-22 presents this part 
of the agency's screening analysis.
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    In the case of costs that may be incurred due to the requirements 
of the proposed revisions to the HCS, all businesses within each of the 
covered industry sectors would be subject to the same requirements. 
Thus, to the extent

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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, if OSHA adopts the proposed revisions to the HCS, 
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 
requirements based on the GHS 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 proposed 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 
($1,221,994; see Table VII-22), revenue impacts (0.0074 percent, 
rounded to 0.01 percent) and profit impacts (0.108 percent, rounded to 
0.11 percent) fall well below OSHA's screening criteria associated with 
economic feasibility concerns. OSHA therefore preliminarily concludes 
that the proposed rule, if implemented, would be economically feasible. 
The agency invites comments on this preliminary conclusion.

H. Preliminary Regulatory Flexibility Act Certification

    To determine whether the proposed 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 proposed rule would impose costs on impacted industries 
for training; for reclassification of aerosols, desensitized 
explosives, and flammable gases; and for becoming familiar with the 
proposed changes to the standard. The proposed rule would also result 
in cost savings to the extent it would limit employers' duties with 
respect to the labeling of some very small containers and provide more 
flexible relabeling requirements for packaged chemicals released for 
shipment.
    OSHA believes that the estimated costs are one-time costs that 
would be incurred during the first-year transition period after the 
rule is promulgated. In addition, as mentioned above, there will be 
annual cost savings due to the flexibilities introduced in the proposed 
provision related to the labeling of very small containers and in the 
proposed released-for-shipment provision.
    Tables VII-23 and VII-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 VII-25 and VII-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.\57\
---------------------------------------------------------------------------

    \57\ 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; Executive Orders 12866, 13563, and 13771; and the 
Unfunded Mandates Reform Act. For a recent example of the 
application of these screening criteria, see the Final Economic 
Analysis and Final Regulatory Flexibility Analysis 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 proposed 
revisions to the HCS for small entities and very small entities are 
estimated to be approximately $17.1 million and $1.7 million, 
respectively (see Tables VII-23 and VII-24). To assess the potential 
economic impact of the proposed 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 VII-23 (small entities) and VII-24 (very small entities). Those 
tables show that in no industries do the annualized costs of the 
proposed 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 VII-25 and VII-26), in no industries 
do the annualized costs of the proposed 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 proposed 
revision to the HCS, OSHA preliminarily certifies that the proposed 
changes to the standard will not have a significant economic impact on 
a substantial number of small entities. The agency invites comments on 
this preliminary certification.

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VIII. Federalism

    OSHA reviewed the proposed updates to the HCS according to the most 
recent Executive order on federalism (E.O. 13132, 64 FR 43255), which 
requires that Federal agencies, to the extent possible, refrain from 
limiting State policy options, consult with States before taking 
actions that would restrict States' policy options and take such 
actions only when clear constitutional and statutory authority exists 
and the problem is of national scope. The Executive order generally 
allows Federal agencies to preempt State law only with the expressed 
consent of Congress. Federal agencies must limit preemption of State 
law to the extent possible.
    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 such States and territories 
as State Plan States. Occupational safety and health standards 
developed by State Plan States 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 Plan States are free to 
develop and enforce their own requirements for 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, the proposed revisions to the HCS would limit State policy 
options in the same manner as every standard or amendment to a standard 
promulgated by OSHA. In States with OSHA-approved State plans, the 
proposed revisions to the HCS would not significantly limit State 
policy options to adopt 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 the proposed revisions to that standard.

VIX. State Plan States

    When Federal OSHA promulgates a new standard or more stringent 
amendment to an existing standard, the 28 States and U.S. territories 
with their own OSHA-approved occupational safety and health plans 
(``State Plan States'') must amend their standards to reflect the new 
standard or amendment or show 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). 
The State standard must be at least as effective as the final Federal 
rule, 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). State 
Plans must adopt the Federal standard or complete their own standard 
within six months of the promulgation date of the final Federal rule. 
When OSHA promulgates a new rule or amendment that does not impose 
additional or more stringent requirements than existing standards, 
State Plan States are not required to amend their standards, although 
OSHA may encourage them to do so.
    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 six states and territories 
have OSHA-approved occupational safety and health plans that cover 
State and local government employees only: Connecticut, Illinois, 
Maine, New Jersey, New York, and the Virgin Islands.

X. Unfunded Mandates Reform Act

    OSHA reviewed this proposal according to the Unfunded Mandates 
Reform Act of 1995 (UMRA), U.S.C. 1501 et seq., and Executive Order 
13132 (64 FR 43255). As discussed in the Preliminary Economic Analysis, 
OSHA has preliminarily concluded that the proposed revisions to the HCS 
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 previously, 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).
    The OSH Act does not cover tribal governments in the performance of 
traditional governmental functions, though it generally does cover 
tribal governments when they engage in commercial activity. The 
proposed 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.
    For these reasons, for the purposes of the UMRA, OSHA certifies 
that this proposal 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. In any event, the Preliminary Economic Analysis constitutes a 
written statement containing a qualitative and quantitative assessment 
of the anticipated costs and benefits. See 2 U.S.C. 1532.

XI. Protecting Children From Environmental Health and Safety Risks

    Executive Order 13045 (62 FR 19885), 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 (i.e., a rulemaking that has an annual effect on the economy of 
$100 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).
    OSHA has preliminarily determined that the proposed revisions to 
the HCS are not economically significant under E.O. 12866 (see Section 
VII of this preamble) and that the standard would not pose 
environmental health or safety

[[Page 9687]]

risks to children as set forth in E.O. 13045.

XII. Environmental Impacts

    OSHA has reviewed the proposed revisions to the HCS 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 the Department of Labor's NEPA procedures (29 CFR part 
11). As a result of that review, OSHA has made a preliminary 
determination that the proposed regulatory changes will have no impact 
on air, water, or soil quality; plant or animal life; or the use of 
land or aspects of the external environment. Therefore, OSHA 
preliminarily concludes that the proposed revisions to the HCS would 
have no significant environmental impacts.

XIII. Consultation and Coordination With Indian Tribal Governments

    OSHA reviewed the proposed revisions to the HCS in accordance with 
E.O. 13175 on ``Consultation and Coordination with Indian Tribal 
Governments'' (65 FR 67249), and determined that it does not have 
``tribal implications'' as defined in that order. The amendments, if 
promulgated, would 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.

XIV. Issues and Options Considered

    OSHA is providing this issues and options section to solicit 
stakeholder input on various regulatory issues and to allow for some 
potential regulatory flexibility with respect to the content of any 
final rule resulting from this rulemaking. While OSHA invites 
stakeholders to comment on all aspects of this proposal, this section 
identifies specific areas of interest to the agency. OSHA is including 
certain issues and questions in this section to assist stakeholders as 
they review the proposal and consider the comments they plan to submit. 
However, to fully understand the questions, and to provide substantive 
input and feedback in response to them, the agency suggests commenters 
review the other sections of the preamble that address these issues in 
detail. Some issues and options that have cost implications are 
discussed more thoroughly in the Preliminary Economic Analysis (see 
Section VII. Preliminary Economic Analysis and Initial Regulatory 
Flexibility Analysis).

A. Issues

    In this section, OSHA solicits public feedback on specific issues 
associated with the proposed revisions to the HCS. It should be noted 
that the proposed regulatory text provided at the end of this document 
only includes those paragraphs that OSHA is proposing to change. 
Therefore, the agency is putting a marked-up version (redline strike 
out) of the text of the current rule on its web page and in the docket 
to help readers identify and understand the proposed changes in context 
(OSHA HCS Redline, 2020, Document ID 0222). The marked-up text will be 
found on www.osha.gov under Hazard Communication in the subject index.
    OSHA has organized this issues section to follow the order of the 
preamble and requests that feedback be organized, to the extent 
possible, in similar order. Comments and feedback on particular 
provisions should contain the heading of the section (e.g., Regulatory 
Text, Appendix A), the associated issue number, and, where appropriate, 
the paragraph in the standard that the comment is addressing. Comments 
addressing more than one section or paragraph should include all 
relevant references. Submitting comments in an organized manner with 
clear reference to the issue(s) raised will enable all participants to 
better understand the issues the commenter addressed and how they 
addressed them. Some commenters may confine their interest (and 
comments) to the issues that specifically affect them; correspondingly 
they will benefit from being able to quickly identify comments on these 
issues in others' submissions. While the agency welcomes relevant 
comments on any aspect of this proposal, OSHA is especially interested 
in responses, supported by evidence and explanations, to the following 
issues and questions:
Timeframe for Updates to the HCS
    Since aligning the HCS with the GHS 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, revision 8 was published in July 2019 (UN GHS, Rev. 8, 
Document ID 0065). Regulatory authorities around the world have 
implemented the GHS at stages ranging from revision 1 through revision 
5. Few regulatory authorities have put programs in place to update 
their regulations on a routine schedule. The European Union (EU) has 
made the most regular updates, and has most recently implemented the 
GHS Rev. 5 in August, 2016 (ECHA, 2016, Document ID 0177). In March 
2019, the European Commission (EC) published the adaptation of 
technical progress (ATP) to EC regulation 1272/2008 (the 
Classification, Labelling, and Packaging (CLP) regulation) to align 
with both the sixth and seventh revised editions of the GHS (EC, 2019, 
Document ID 0176). These changes to the EC regulation become effective 
October 17, 2020. Other regulatory authorities, such as those in 
Canada, Australia, and New Zealand, have indicated that they will 
continue to update their regulations to align with the GHS and are in 
the process of aligning with Rev. 7; however, none of these countries 
have a mandate on how often they should do so (Canada, 2019, Document 
ID 0172; Australia, 2020, Document ID 0168; New Zealand, 2018, Document 
ID 0187). Similarly, to date, OSHA has not adopted a specific timeframe 
for regularly updating the HCS to implement GHS updates.
    As stated previously, OSHA is proposing to align the HCS with the 
GHS Rev. 7, consistent with the actions of most of the countries listed 
above (EC, 2019, Document ID 0176; Canada, 2019, Document ID 0172; 
Australia, 2020, Document ID 0168; New Zealand, 2018, Document ID 
0187). A more thorough explanation of OSHA's preliminary decision to 
align the HCS with the GHS Rev. 7 is detailed in the introduction to 
Section XV.
    OSHA requests 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. More frequently 
updating the HCS to align with the GHS may provide greater protection 
for workers and reduce uncertainty for manufacturers, distributors, and 
employers. For example, in the GHS Rev. 7, several hazard classes have 
been updated to include additional hazard sub-categories and improved 
hazard information that will increase clarity and, therefore, 
protections for workers.
    OSHA is interested in receiving public comment about the utility, 
costs, or other issues that might be associated with regular updates 
and about specific timeframes or criteria that OSHA should consider 
when determining when and whether to update the HCS. Specifically, 
would longer time periods between updates and realignment with the GHS 
and other standards be more or less burdensome for employers, 
especially those that operate

[[Page 9688]]

internationally? Would regular, shorter time periods provide more 
stability? How would longer or shorter periods between realignment 
affect worker protection?
Regulatory Text
    (1) Under paragraph (f), Labels and other forms of warning, OSHA is 
proposing changes to paragraphs (f)(5) (bulk shipments) and (f)(11) 
(released-for-shipment) and is also proposing to add a new paragraph 
(f)(12) containing provisions specific to labelling on small 
containers.
    (a) OSHA is requesting comments on the proposed additions to 
paragraph (f)(5), which would be newly titled Transportation. Proposed 
paragraph (f)(5)(ii) would provide that labels for bulk shipments may 
be placed on the immediate container or may 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. OSHA 
requests comments on the usefulness and effectiveness of allowing these 
alternate approaches for labeling bulk shipments.
    (b) OSHA is proposing to update paragraph (f)(11) to provide that 
chemicals that have been released for shipment and are awaiting future 
distribution need not be relabeled to incorporate new significant 
information about hazards; however, the chemical manufacturer or 
importer would still have to provide the updated label for each 
individual container with each shipment. The purpose of this proposal 
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 (e.g., chemical exposures, ergonomic 
issues). OSHA requests comments on whether it is appropriate to use 
``released for shipment'' as the cutoff point for relabeling 
requirements, as opposed to, for example, the time of shipment. Would 
the proposed provision reduce worker protections, considering OSHA is 
also proposing to require that the updated label be sent with the 
shipment? Would the proposed change result in any cost savings?
    (c) OSHA is proposing a new paragraph (f)(12) addressing labeling 
requirements for small containers. All of the provisions in this 
proposed paragraph would 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). Paragraph (f)(12)(ii), as 
proposed, would provide that labels for small containers less than or 
equal to 100 ml capacity must include just the 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. In 
addition, proposed (f)(12)(iii) would eliminate labeling requirements 
for small containers less than or equal to 3 ml capacity where the 
manufacturer, importer, or distributor can demonstrate that any label 
would interfere with the normal use of the container; in such cases, 
however, the proposed revisions to the standard would require the 
container to bear, at a minimum, the product identifier. For example, 
the product identifier could be etched on a small glass vial. This 
would ensure that each small container can be identified and linked 
with the full label information on the immediate outer package. OSHA is 
also proposing a provision at paragraph (f)(12)(iv), applicable to all 
small containers covered by paragraph (f)(12)(ii) or (iii), providing 
that the immediate outer package must include (1) the full label 
information for each hazardous chemical in the immediate outer package; 
and (2) a statement indicating that the small container(s) inside must 
be stored in the immediate outer package (bearing the complete label) 
when not in use. OSHA requests comments on the feasibility of, and any 
cost savings associated with, these proposed provisions for the 
labeling of small containers (both 100 ml and less and 3 ml and less). 
The agency also requests information on whether the proposed labeling 
requirements would be adequate to provide for safe handling and storage 
of chemicals in small containers. In addition, OSHA is interested in 
receiving comments on two specific alternatives to proposed paragraph 
(f)(12). First, instead of adopting proposed paragraph (f)(12), should 
OSHA simply allow for case-by-case exemptions if full labeling is not 
feasible? Second, should the agency require a showing that a full label 
would interfere with the normal use of the container before permitting 
the use of abbreviated labels on containers with a capacity of 100 ml 
and less (similar to the condition OSHA is proposing in paragraph 
(f)(12)(iii) for containers with a capacity of 3 ml and less)? Please 
provide reasons for your answers.
    (2) Under paragraph (g) Safety data sheets, OSHA is proposing a 
change to paragraph (g)(10), which addresses the form and storage of 
safety data sheets, to allow SDSs to be stored, rather than designed, 
in a way that covers groups of hazardous chemicals in a work area. The 
original term ``design'' was used when OSHA did not require a specific 
format for material safety data sheets (MSDSs), but now that OSHA 
requires SDSs to be in a standard 16-section format, the agency is 
proposing to clarify that this paragraph refers to storage only. OSHA 
requests comments regarding whether this proposed revision would 
require significant changes to current practices.
    (3) Under paragraph (i), Trade secrets, OSHA is proposing two 
significant changes.
    (a) First, OSHA is proposing to allow manufacturers, importers, and 
employers to withhold a chemical's concentration range as a trade 
secret.
    (b) Second, in proposed paragraphs (i)(1)(iv)(A) through (M), OSHA 
is proposing 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; the 
proposed ranges are the same as those required by Canada, a major 
trading partner of the United States (Canada, 2019, Document ID 0172).
    OSHA currently does not permit manufacturers to claim concentration 
ranges as trade secrets (Colau, 2017, Document ID 0098; Nelson, 2017, 
Document ID 0099), and is requesting comments on its proposal to do so. 
Specifically, the agency is interested in any experience stakeholders 
have had with developing SDSs using the prescribed concentration ranges 
and any concerns stakeholders have about using concentration ranges on 
the SDS. The agency is also requesting comments addressing the adequacy 
of hazard information provided by these ranges. Do these ranges provide 
sufficient information for downstream manufacturers to conduct hazard 
classifications? Are the ranges prescribed too wide to provide 
sufficient information to protect workers (i.e., should they be 
narrowed)? Notably, proposed paragraph (i)(1)(v) provides that the 
prescribed concentration range used must be the narrowest range 
possible. If the exact concentration range falls between 0.1% and 30% 
(proposed paragraphs (i)(1)(iv)(A) through (G)) and does not fit 
entirely into one of the prescribed concentration ranges, a single 
range created by the combination of two applicable consecutive ranges 
could be disclosed instead, provided that the combined concentration 
range does not include any range that falls entirely outside the

[[Page 9689]]

exact concentration range in which the ingredient is present. OSHA 
invites comments on whether it should allow combinations among all 
ranges (i.e., all of the ranges (up to 100% concentration) listed in 
proposed paragraphs (i)(1)(iv)(A) through (M)) or whether the rule 
applicable to combining ranges should be even more restrictive (e.g., 
only for the ranges (up to 10% concentration) listed in proposed 
paragraphs (i)(1)(iv)(A) through (E)). OSHA is also interested in 
receiving comments on whether there are any economic implications 
associated with including the prescribed concentration ranges.
Appendix B
    OSHA is proposing several substantive updates to appendix B (as 
outlined in Section XV, Summary and Explanation). These include the 
addition of a new hazard class (desensitized explosives) and several 
new hazard categories (unstable gases and pyrophoric gases in the 
Flammable Gases class and nonflammable aerosols in the Aerosols class). 
OSHA has 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. 
OSHA is requesting comments on whether these changes provide improved 
safety through more targeted hazard statements, precautionary 
statements and pictograms.
Appendix C
    OSHA has proposed numerous changes to appendix C, many of which are 
editorial, clarifying, or organizational in nature and are designed to 
clarify requirements for preparing labels. The agency is also proposing 
some substantive changes to correspond to proposed changes to appendix 
B or the regulatory text. In paragraph C.2.4.10, OSHA is proposing to 
require prioritization of certain precautionary statements related to 
medical response (see Section XV, Summary and Explanation, Appendix C, 
Proposed Revisions to Table C.2.4.). The agency requests comments on 
the particular system of prioritization specified in proposed C.2.4.10 
and on whether the proposed prioritization provisions would improve 
clarity on labels.
Appendix D
    Many of the issues related to changes proposed for appendix D are 
discussed in the summary and explanation of the regulatory text (see 
Section XV, Summary and Explanation, Regulatory Text), specifically in 
the discussion of OSHA's proposed changes to paragraphs (c), (g), and 
(i). OSHA requests comments on the following additional issues:
    OSHA is proposing changes to section 2 of the SDS to emphasize that 
hazards identified under normal conditions of use that result from a 
chemical reaction must appear on the SDS, even though these hazards do 
not need to be listed on the label. This proposed change would simply 
reorganize the information presented in the SDS, as discussed in 
Section XV (Summary and Explanation, Appendix D). OSHA is requesting 
comments on whether the text OSHA is proposing for paragraph (c) in 
section 2 would clarify when it is appropriate to include information 
on the hazards associated with a change in the chemical's physical form 
or chemical reaction under normal conditions of use and the type of 
information that should be presented in section 2 of the SDS.
    With some conditions, the HCS currently requires section 3 of the 
SDS to include the chemical name 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. 
OSHA is not proposing to change this requirement, but is interested in 
comments on whether it should be expanded to include all classified 
chemicals (i.e., also physical hazards and HNOCSs). Such a requirement 
would be similar to the EU REACh regulations, which require SDS 
preparers to list the classification of each hazardous ingredient 
(ECHA, 2016, Document ID 0177). Would expanding the requirements for 
section 3 in this way ensure that both users and manufacturers fully 
understand any potential hazard when handling the chemical? Would such 
a change result in the provision of additional information that would 
allow downstream manufacturers to more accurately classify their 
products where the mixture in question is one of their ingredients?
    The use of newer electronic technology, such as quick response (QR) 
codes and radio-frequency identification (RFID), on package labels give 
responsible parties the ability to communicate information on chemical 
hazards in a variety of formats. In the December 2018 session of the UN 
Sub-committee, the members of an informal working group on labeling of 
small containers agreed to extend its scope beyond small containers 
and, accordingly, to change its name to ``Practical Labelling Issues.'' 
Among other activities proposed for the biennium 2019-2020, the working 
group planned to ``[r]eview the existing digital means of communication 
that can be used to convey the GHS hazard information to users (e.g., 
electronic label, QR code etc.),'' ``consider the development of 
general principles and criteria on the provision of this information 
digitally,'' and ``develop guidance and examples wherever 
appropriate.'' (UN GHS, 2019, Document ID 0198; UN Secretariat, 2019, 
Document ID 0196).
    As an example, a paper presented at the December 2018 session of 
the UN sub-committee noted that there are international efforts 
``actively promoting the application of electronic labels for 
chemicals'' in such industrial processes as production; management of 
cylinders, laboratory samples, and warehouse operations; and the 
supervision of competent persons (UN GHS, 2019, Document ID 0198). The 
paper noted that common types of electronic labels include QR codes and 
RFID. The paper also discussed efforts to develop national standards on 
electronic labeling ``to establish a complete integrated information 
managing standard system based on chemical electronic labels and safety 
data'' in order to ``further ensure the effectiveness of chemical 
safety supervision, promote the implementation of the Globally 
Harmonized System of Classification and Labelling of Chemicals, and 
facilitate . . . trade.'' Among the benefits of practical labeling 
cited by the sub-committee expert are the convenience and efficiency 
derived from ``unified information collection,'' ``dynamic 
management,'' and ``real-time monitoring''; the ability to store a 
large capacity of information, reaching multiple mega-byte levels; and 
``[improvement in] the level of safety management in complex 
scenarios.'' (UN GHS, 2018, Document ID 0082).
    OSHA invites comments on the use of electronic labeling for 
chemical packaging. If a future revision to the HCS permitted some form 
of electronic labeling, what technological, economic, and security 
challenges would affected employers face? The agency also requests 
comments on the types of electronic chemical labeling already in 
existence or under development. For employers already implementing 
electronic labeling programs in the United States or in other 
countries, please provide information on the types of electronic coding 
systems utilized in the program and the costs incurred and benefits 
achieved from the program.

[[Page 9690]]

What back-up measures are in place to ensure immediate access to the 
hazard information? OSHA is interested in information about workers' 
experiences with the use of electronic labels. OSHA also requests 
comments on foreseeable challenges that OSHA should consider (e.g., 
worker accessibility to electronic label information).
Preliminary Economic Analysis
    (1) As explained in the preliminary economic analysis (see Section 
VII.F. Compliance Costs and Cost Savings), some chemical production and 
logistics employees who receive training under the provisions of the 
existing HCS would need to receive additional training to become 
familiar with the updates to SDSs and labels for impacted aerosols, 
desensitized explosives, and flammable gases. OSHA has preliminarily 
determined that the incremental training costs employers would incur 
for these employees will be relatively small (estimated annualized 
training costs of $120,158 for all affected employers). OSHA also 
believes that users of aerosols, desensitized explosives, and flammable 
gases in the workplace are already trained on the hazards of these 
chemicals and therefore would need to devote only a trivial amount of 
time, if any time at all, to additional training associated with the 
reclassification of these chemicals. Per the discussion of this issue 
in the preliminary economic analysis (see ``Costs Associated with 
Training Employees'' in Section VII.F. Compliance Costs and Cost 
Savings), OSHA acknowledges that some user training might be required 
for non-flammable aerosols not under pressure; the agency has 
preliminarily concluded, however, that such training time would be 
negligible given that, as discussed in Section XV.C (see Section XV, 
Summary and Explanation for Appendix B), most aerosols are currently 
classified as gases under pressure and therefore are already covered 
under the HCS. The agency requests comments on all of its preliminary 
conclusions regarding training time for users of reclassified 
chemicals.
    (2) For purposes of estimating the costs associated with the 
proposed new hazard classification requirements, OSHA estimates that a 
Health & Safety Specialist would spend 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 (see ``Costs Associated with 
Reclassifications and Revisions to Safety Data Sheets and Labels'' in 
Section VII.F, Compliance Costs and Cost Savings). At a loaded hourly 
wage of $56.87, this results in estimated unit costs of $101.51, 
$72.51, and $43.50 per SDS for small, medium, and large establishments, 
respectively. OSHA invites interested parties to comment on these 
estimates.
    (3) For purposes of estimating the costs associated with revising 
labels and SDSs to conform to the revisions OSHA is proposing to 
mandatory language in the appendices, OSHA estimates that a Health & 
Safety Specialist would spend 0.7 hours per SDS for establishments with 
fewer than 100 employees; 0.5 hours per SDS for establishments with 
100-499 employees; and 0.3 hours per SDS for establishments with 500 or 
more employees (see ``Revisions to SDSs and Labels Due to Revised 
Precautionary Statements,'' in Section VII.F. Compliance Costs and Cost 
Savings). At a loaded hourly wage of $56.39, this results in estimated 
unit costs of $40.60, $29.00, and $17.40 per SDS for small, medium, and 
large establishments, respectively. OSHA invites interested parties to 
comment on these estimates.
    (4) To estimate the costs (cost savings) associated with the 
proposed released-for-shipment provisions in paragraph (f)(11), OSHA 
presented a cost methodology that required estimating four factors: (1) 
Cost savings (estimated relabeling costs) as a percentage of the value 
of the products needing relabeling; (2) the percentage of products in 
the affected NAICS industries that would be warehoused for more than 
six months; (3) the percentage of products warehoused for more than six 
months that would require relabeling in any particular year due to a 
manufacturer-initiated labeling change; \58\ and (4) the percentage of 
all products in the NAICS industries that would be covered by the 
proposed revisions to the HCS. The estimated percentages are shown in 
Table VI-17: Calculation of the Percentage Loss Avoided Due to the 
Proposed Released-for-Shipment Provision. OSHA requests public comments 
on its estimates for each of the four factors described above and shown 
in Table VI-17.
---------------------------------------------------------------------------

    \58\ That is, a labeling change resulting from new information 
obtained by the manufacturer and not from a new legal requirement.
---------------------------------------------------------------------------

    (5) As described in the PEA (see ``Released for Shipment'' in 
Section VII.F. Compliance Costs and Cost Savings), OSHA anticipates 
that the proposed modifications to paragraph (f)(11) addressing 
chemicals that have been released for shipment would result in cost 
savings for 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 identified six industries (NAICS 325311 
Nitrogenous fertilizer manufacturing, NAICS 325312 Phosphatic 
fertilizer manufacturing, NAICS 325314 Fertilizer (mixing only) 
manufacturing, NAICS 325510 Paint and coating manufacturing, NAICS 
424910 Farm supplies merchant wholesalers, and NAICS 424950 Paint, 
varnish, and supplies merchant wholesalers) that it expects would be 
impacted by the proposed modifications to paragraph (f)(11); see Table 
VI-17 in Section VII.D. Health and Safety Benefits and Unquantified 
Positive Economic Effects. OSHA invites comments on whether other 
industries would be affected by this proposed modification and whether 
there might be other cost or health effects resulting from this 
proposed modification that OSHA did not consider in this proposal.
    (6) Also with respect to the estimate of cost savings associated 
with the proposed released-for-shipment provisions, OSHA assumes that 
if the relabeling costs associated with paragraph (f)(11) exceed the 
value of the product, manufacturers and wholesalers will discard the 
product rather than pay to relabel it. There may be some disposal costs 
for the discarded material, but there may also be some salvage value to 
the improperly-labeled product. In the preliminary economic analysis 
(see ``Released for Shipment'' in Section VII.F. Compliance Costs and 
Cost Savings), OSHA estimates, without further information on the 
distribution of the costs, that the average labeling cost is 
approximately 50 percent of the value of the products requiring 
relabeling. The agency invites comments on this assumption.

B. Options

    In this section, OSHA presents a list of options that are under 
consideration for the proposed update to the HCS. The agency is 
requesting public comment on these options.
Regulatory Text
    (1) OSHA is proposing, in paragraph (i), to mandate the use of 
prescriptive concentration ranges whenever an actual concentration or 
concentration range is being claimed as a trade secret. This change is 
being proposed, in part, to better align with Canada's Workplace

[[Page 9691]]

Hazardous Materials Information System (WHMIS), allowing manufacturers, 
importers, and employers the ability to use the same SDS for both U.S. 
and Canadian workplaces. However, the agency is also considering a non-
mandatory option for this provision. Under this scenario, OSHA would 
provide non-mandatory guidance on the use of concentration ranges, but 
would not require their use. This would allow manufacturers, importers, 
and employers flexibility to follow the current HCS requirements (which 
do not require the use of any concentration ranges when the actual 
concentration is claimed as a trade secret) or move to a system that 
aligns with WHMIS. OSHA is requesting comments on this option. Would 
this option provide beneficial flexibility to manufacturers, importers, 
and employers? Would this option be too confusing, and potentially 
weaken protective effects that would be associated with providing 
prescribed concentration ranges? How would this affect employee safety 
and comprehension?
    (2) Under paragraph (i), OSHA is also considering allowing 
manufacturers and importers to provide their own ranges as long as the 
range is narrower than any prescribed range. This alternative could 
allow manufacturers and importers to provide downstream users with more 
precise information while still being able to claim a trade secret. 
This would be consistent with an approach Health Canada is considering 
(Canada, 2019, Document ID 0172). OSHA is seeking comments on the 
usefulness and viability of this option.
Revision 8 Changes
    The GHS Rev. 8 was published in July 2019 and contains many changes 
from Rev. 7, including updates to certain hazard classification 
criteria, systematic updates to the definitions in the health hazard 
chapters, updates to hazard and precautionary statements, and updated 
labeling examples. An overview of the changes can be found in Document 
ID 0243. As discussed more thoroughly in the introduction to the 
Summary and Explanation (see Section XV), OSHA has preliminarily 
decided to use this proposed update to align the HCS with the GHS Rev. 
7. However, OSHA has also identified specific updates found in the GHS 
Rev. 8 that are significant enough to warrant consideration in this 
rulemaking. Below, the agency highlights several updates from the GHS 
Rev. 8 and invites public comments on whether OSHA should consider 
adopting these updates.
1. Appendix A (Based on the GHS Rev. 8)
    OSHA is proposing substantial revisions to appendix A.2 (skin 
corrosion/irritation) that reflect changes the UN subcommittee adopted 
through the GHS Rev. 7. However, the GHS Rev. 8, published in July 2019 
(UN GHS, 2019, Document ID 0065), 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. The expansion of 
non-animal test methods for use in hazard classification could 
potentially result in cost savings, as hazard testing for new chemicals 
could be done using potentially cheaper (non-animal) test methods. If 
OSHA were to adopt these changes, they would be reflected in appendix 
A.2 Skin Corrosion/Irritation.
BILLING CODE 4510-26-P

[[Page 9692]]

[GRAPHIC] [TIFF OMITTED] TP16FE21.079

BILLING CODE 4510-26-C
    Table 3.2.1 from the GHS Rev. 8 (shown above) provides an update to 
the tiered approach for classification. In recognition of the 
advancements made in non-animal test methods, the update includes an 
elevation in acceptance of in vitro data to tier 2 of the approach. The 
updated tiered approach also includes 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 updates the 
background information to provide additional guidance for how to use 
non-animal test data to classify chemicals. 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. The agency believes the greatest benefit would 
be for new chemicals where no existing data currently exists. Although 
OSHA does not require testing, OSHA currently encourages chemical 
manufacturers wanting to develop hazard information for new chemicals 
to utilize non-animal testing strategies to develop hazard information. 
Should OSHA adopt Chapter 3.2 from the GHS Rev. 8 with all of the 
revisions to the classification scheme? Please explain your opinion and 
provide any relevant data or other information.
2. Appendix B (Based on the GHS Rev. 8)
    In this NPRM, OSHA is proposing updates to the classification and 
labeling of aerosols that will align with the GHS Rev. 7. However, the 
GHS Rev. 8 contains several significant additional changes in the 
aerosol chapter. OSHA requests comments on whether the agency should 
adopt two specific changes that appear in the GHS Rev. 8. First, the 
GHS 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. 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 (Sec.  1910.1200, appendix B). 
OSHA has preliminarily determined that there are no substantive 
differences between OSHA's current text and the text

[[Page 9693]]

represented in the new Rev. 8 table (reproduced below), although they 
do not contain exactly the same language (UN GHS, Rev. 8, Document ID 
0065).

         Table XIV--Rev. 8 Classification Criteria for Aerosols
                    [From the GHS Rev. 8 Table 2.3.1]
------------------------------------------------------------------------
         Category                             Criteria
------------------------------------------------------------------------
1........................  (1) Any aerosol that contains >=85% flammable
                            components (by mass) and has a heat of
                            combustion of >=30 kJ/g;
                           (2) Any aerosol that dispenses a spray that,
                            in the ignition distance test, has an
                            ignition distance of >=75 cm; or
                           (3) Any aerosol that dispenses a foam that,
                            in the foam flammability test, has:
                           (a) a flame height of >=20 cm and a flame
                            duration of >=2 s; or
                           (b) a flame height of >=4 cm and a flame
                            duration of >=7 s.
2........................  (1) Any aerosol that dispenses a spray that,
                            based on the results of the ignition
                            distance test, does not meet the criteria
                            for Category 1, and which has:
                           (a) A heat of combustion of >=20 kJ/g;
                           (b) a heat of combustion of <20 kJ/g along
                            with an ignition distance of >=15 cm; or
                           (c) a heat of combustion of <20 kJ/g and an
                            ignition distance of <15 cm along with
                            either, in the enclosed space ignition test:
                              A time equivalent of <=300 s/m3; or
                              a deflagration density of <=300 g/m3; or
                           (2) Any aerosol that dispenses a foam that,
                            based on the results of the aerosol foam
                            flammability test, does not meet the
                            criteria for Category 1, and which has a
                            flame height of >=4 cm and a flame duration
                            of >=2 s.
3........................  (1) Any aerosol that contains <=1% flammable
                            components (by mass) and that has a heat of
                            combustion <20 kJ/g; or
                           (2) Any aerosol that contains >1% (by mass)
                            flammable components or which has a heat of
                            combustion of >=20 kJ/g but which, based on
                            the results of the ignition distance test,
                            the enclosed space ignition test or the
                            aerosol foam flammability test, does not
                            meet the criteria for Category 1 or Category
                            2.
------------------------------------------------------------------------

    Should OSHA adopt the classification criteria for the aerosols 
hazard class as presented above? While the criteria themselves would 
not change as compared to OSHA's existing standard, adopting the 
precise language in the GHS text may minimize confusion.
    Second, in Rev. 8, the GHS adopted a new hazard category within the 
aerosols class: Chemicals under pressure (UN GHS, 2019, Document ID 
0065; UN GHS, 2018, Document ID 0247; UN GHS, 2018, Document ID 0248). 
These products function similarly to aerosol dispensers (UN 1950), but 
are packed in pressure receptacles (refillable and non-refillable) up 
to 450 liters ((UN GHS, 2019, Document ID 0065; UN TDG, 2020, Document 
ID 0195). Chemicals under pressure used for spray applications present 
hazards that are similar to those presented by aerosol dispensers. 
Therefore, the classification criteria and hazard information are the 
same as for aerosols. OSHA recognizes 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). Should OSHA consider adopting the new hazard category of 
chemicals under pressure in the aerosol chapter?
3. Appendix C (Based on the GHS Rev. 8)
    In this NPRM, OSHA is proposing to update a number of precautionary 
statements to align with the GHS Rev. 7. However, the GHS Rev. 8 
includes additional revisions to precautionary statements, most notably 
an overhaul of the medical response precautionary statements (UN GHS, 
2019, Document ID 0065). These precautionary statements were revised 
for the GHS Rev. 8 because, among other reasons, manufacturers and 
suppliers had difficulty choosing the appropriate wording where options 
were given (e.g., choosing between calling a poison center or doctor, 
or choosing between medical advice or attention) (UN GHS, 2019, 
Document ID 0065).

                        Table XV--Revised Medical Response Statements From the GHS Rev. 8
----------------------------------------------------------------------------------------------------------------
                   Response precautionary
       Code              statements             Hazard class           Hazard category       Conditions for use
----------------------------------------------------------------------------------------------------------------
P316.............  Get emergency medical   Acute toxicity, oral    1, 2, 3...............  Competent Authority
                    help immediately.       (chapter 3.1).         1, 2, 3...............   or manufacturer/
                                           Acute toxicity, dermal  1, 2, 3...............   supplier may add,
                                            (chapter 3.1).         1, 1A, 1B, 1C.........   `Call' followed by
                                           Acute toxicity,                                  the appropriate
                                            inhalation (chapter                             emergency telephone
                                            3.1).                                           number, or the
                                           Skin corrosion                                   appropriate
                                            (chapter 3.2).                                  emergency medical
                                                                                            help provider, for
                                                                                            example, a Poison
                                                                                            Centre, Emergency
                                                                                            Centre or Doctor.
                                           Respiratory             1, 1A, 1B.............
                                            sensitization
                                            (chapter 3.4).
                                           Specific target organ   1, 2..................
                                            toxicity, single
                                            exposure; (chapter
                                            3.8).
                                           Aspiration hazard       1, 2..................
                                            (chapter 3.10).
P317.............  Get medical help......  Gases under pressure    Refrigerated liquefied
                                            (chapter 2.5).          gas.
                                           Acute toxicity, oral    4, 5..................
                                            (chapter 3.1).
                                           Acute toxicity, dermal  4, 5..................
                                            (chapter 3.1).
                                           Acute toxicity,         4, 5..................
                                            inhalation (chapter
                                            3.1).
                                           Skin irritation         2, 3..................
                                            (chapter 3.2).
                                           Serious eye damage      1.....................
                                            (chapter 3.3).
                                           Eye irritation          2/2A, 2B..............
                                            (chapter 3.3).
                                           Skin sensitization      1, 1A, 1B.............
                                            (chapter 3.4).
P318.............  If exposed or           Germ cell mutagenicity  1, 1A, 1B, 2..........
                    concerned, get          (chapter 3.5).
                    medical advice.
                                           Carcinogenicity         1, 1A, 1B, 2..........
                                            (chapter 3.6).

[[Page 9694]]

 
                                           Reproductive toxicity   1, 1A, 1B, 2..........
                                            (chapter 3.7).
                                           Reproductive toxicity,  Additional category...
                                            effects on or via
                                            lactation (chapter
                                            3.7).
P319.............  Get medical help if     Specific target organ   3.....................
                    you feel unwell.        toxicity, single
                                            exposure; respiratory
                                            tract irritation
                                            (chapter 3.8).
                                           Specific target organ   3.....................
                                            toxicity, single
                                            exposure; narcotic
                                            effects (chapter 3.8).
                                           Specific target organ   1, 2..................
                                            toxicity, repeated
                                            exposure (chapter
                                            3.9).
----------------------------------------------------------------------------------------------------------------

    As the new statements used in the GHS Rev. 8 provide standardized 
language and do not require manufacturers and suppliers to decide which 
statement is most appropriate, adopting these statements in the HCS as 
part of this rulemaking might save manufacturers or importers time and/
or money compared to the existing statements. OSHA also believes that 
these statements could improve hazard communication and worker safety 
by more effectively conveying the type of medical action that is 
necessary. OSHA seeks comments on the potential benefits or drawbacks 
associated with adopting these revised medical response statements, or 
other precautionary statements that are part of the GHS Rev. 8, as a 
part of this rulemaking (see also Summary and Explanation, Section 
XV.D. Appendix C). OSHA's existing enforcement policy, as described in 
the OSHA hazard communication directive (OSHA, 2015, Document ID 0007), 
addresses situations in which employers may use precautionary 
statements from a more recent version of the GHS; does the policy 
described in the directive provide sufficient flexibility?
Incorporation by Reference
    OSHA is proposing to revise the general incorporation by reference 
section, 29 CFR 1910.6, to include updated test methods referenced in 
the proposed revisions to the HCS. OSHA does not intend to require 
chemicals already classified using an earlier version of a consensus 
standard to be reclassified. 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 is considering ways to clarify this in the final 
regulatory text, e.g., 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 invites comments on this topic.

XV. Summary and Explanation of the Proposed Modifications to the Hazard 
Communication Standard

    This section of the preamble explains OSHA's proposed changes to 
the HCS (29 CFR 1910.1200). OSHA is proposing to align this 
modification of the HCS with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060). The agency has preliminarily decided to base most of the GHS 
alignment on Rev. 7 for several reasons, even though Rev. 8 of the GHS 
was issued in July 2019 (UN GHS, 2019, Document ID 0065). First, OSHA 
began its work to update the standard prior to the release of Rev. 8. 
While OSHA has always intended the HCS to be evergreen, preparation for 
amending any standard is a time-consuming process and changing course 
would have resulted in a significant delay to this rulemaking. Second, 
the U.S.'s major trading partners (Canada, Europe, Australia, and New 
Zealand) are all preparing to align with Rev. 7 (Canada, 2019, Document 
ID 0172; Australia, 2020, Document ID 0168; New Zealand, 2018, Document 
ID 0187; EC, 2019, Document ID 0176). Third, OSHA has discussed the 
potential for adopting some of the most consequential changes from Rev. 
8 in the Issues and Options section (see Section XIV, Issues and 
Options Considered).
    In general, OSHA has received broad support for this rulemaking. 
During OSHA's informal discussion with stakeholders in November 2016 
about the potential changes to the HCS (Docket No. OSHA-2016-005), the 
agency received feedback supporting continued alignment of the HCS with 
the GHS and Health Canada, as well as support for addressing various 
implementation issues under the existing HCS (API, 2016, Document ID 
OSHA-2016-0005-0026; ACC, 2016, Document ID OSHA-2016-0005-0014; NGFA, 
2016, Document ID OSHA-2016-0005-0018; AFIA, 2016, Document ID OSHA-
2016-0005-0017). The proposed changes are intended to improve and 
enhance worker protection with regard to hazard communication by 
incorporating new hazard classes and categories, improving and 
streamlining precautionary statements, and providing additional 
clarification of existing regulatory requirements. The following is a 
discussion, by provision, of the proposed revisions to the standard.
    In the discussion of the proposed modifications to the appendices, 
OSHA describes certain proposed changes that would affect multiple 
hazard classes. OSHA discusses some changes in general terms and 
indicates where those changes occur. However, to aid stakeholders, so 
they can see the proposed changes in context, OSHA is placing in the 
docket and on its website a redline strikeout version of all of the 
proposed revisions to the current HCS and appendices (OSHA HCS Redline, 
2020, Document ID 0222; https://www.osha.gov/dsg/hazcom/).

A. Incorporation by Reference

    OSHA is proposing to update the general incorporation by reference 
section, 29 CFR 1910.6, to include the national/international consensus 
standards listed below. OSHA does not intend to require chemicals 
already classified using an earlier version of a consensus standard to 
be reclassified. 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 is considering ways to clarify this in the final regulatory text, 
e.g., 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 invites 
comments on this topic.
    In places where OSHA is proposing to cite to new or updated 
national/international consensus standards in the regulatory text and 
appendix B, OSHA

[[Page 9695]]

is proposing to include the title, edition/version, and year of the 
standard in the relevant reference for the benefit of stakeholders and 
for ease of compliance. OSHA is not currently proposing to add/update 
all existing references to consensus standards in the regulatory text 
and appendix B, but recognizes that in some places in the existing text 
consensus standards are cited without specific reference to the year, 
edition, or full title of the relevant standard. In such cases, 
stakeholders need to consult with Sec.  1910.6 to find more details 
regarding the specific consensus standard that has been incorporated by 
reference in the HCS. For example, appendix B, Section B.6.3 (Flammable 
Liquids), incorporates by reference ASTM D1078, and Sec.  1910.6 
specifies that the version of that standard incorporated by reference 
is the one approved on May 15, 2005. Since there are many versions of 
ASTM D1078 available, OSHA realizes that the general reference to ASTM 
D1078 in appendix B could cause confusion to those classifying new 
chemicals. OSHA is requesting comments on whether additional 
information (year, edition/version, full title) should be added to all 
of the references to consensus standards that are already incorporated 
by reference in the HCS.
    OSHA is proposing to incorporate by reference (in Sec.  1910.6) the 
materials below. A brief description of each consensus standard is 
provided in the text below. A description of their use can be found in 
the Regulatory Text, Appendices, and Summary and Explanation for the 
Regulatory Text and Appendices (see Section XV.A and D) where the 
standard is referenced. Each standard is available for purchase through 
the publication agencies listed below:
 Regulatory Text--Paragraph c (Definitions)
    [cir] ASTM D 4359-90 (2019)--Standard Test Method for Determining 
Whether a Material is a Liquid or a Solid, Re-approved 2019: This 
consensus standard provides specific details regarding the test methods 
used to determine whether a viscous material is a liquid or solid.
    [ssquf] ASTM, International: https://astm.org/Standard/standards-and-publications.html.
    [cir] European Agreement Concerning the International Carriage of 
Dangerous Goods by Road (ADR): This consensus standard provides test 
methods for determining the specific physical characteristics of a 
liquid.
    [ssquf] https://shop.un.org/series/european-agreement-concerning-international-carriage-dangerous-goods-road-adr.
 Appendix B.1.3--Explosives
    [cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport 
of Dangerous Goods, Manual of Tests and Criteria, Part I: This 
consensus standard provides test methods to determine if a substance 
has explosive properties, the degree of sensitivity of the explosive 
properties, and stability of explosive properties. The consensus 
standard also provides information on the procedures for classification 
of explosive materials.
    [ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
 Appendix B.2.3--Flammable Gases
    [cir] ISO 10156:2010, Gases and Gas Mixtures--Determination of Fire 
Potential and Oxidizing Ability for the Selection of Cylinder Valve 
Outlets, Third Edition, April, 2010: This consensus standard provides 
specific details of the methods used to determine flammability of a gas 
or gas mixture. The standard also provides methods for determining if a 
gas or gas mixture is more or less oxidizing than air under atmospheric 
conditions. The intention of the standard is for classifying gases and 
gas mixtures as flammable gases and can be used to select the 
appropriate gas cylinder valve outlet for the flammability 
classification.
    [ssquf] International Organization for Standards; https://iso.org/store.html.
    [cir] ISO 817:2014 Refrigerants--Designation and safety 
classification: This consensus standard establishes a safety 
classification system based on the toxicity and flammability of the 
refrigerant. It also provides guidance on how to determine a 
refrigerant concentration limit.
    [ssquf] International Organization for Standards; https://iso.org/store.html.
    [cir] IEC 60079-20-1 ed. 1.0 (2010-01) Explosive atmospheres--Part 
20-1: Material characteristics for gas and vapor classification--Test 
methods and data: This consensus standard provides guidance for 
classification of gas-air mixtures and vapor-air mixtures under normal 
conditions of pressure/temperature while also providing guidance on the 
appropriate selection of equipment. In addition, the standard provides 
guidance for determining the auto-ignition temperature of gas-air 
mixtures and vapor-air mixtures with additional information provided to 
guide selection of appropriate equipment for use in hazardous areas.
    [ssquf] International Electrotechnical Commission: https://iec.ch/index/htm#buy.
    [cir] DIN 51794 Determining the ignition temperature of petroleum 
products: This consensus standard provides detailed information on test 
methods used to determine the ignition temperature of petroleum 
products. The standard applies to flammable gases and liquids in a 
specific range of ignition temperature (75-650 [deg]C) with particular 
emphasis on mineral oils hydrocarbons and their mixtures,
    [ssquf] German Institute of Standards: https://din.de/en/about-standards/buy-standards.
    [cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport 
of Dangerous Goods, Manual of Tests and Criteria, Part III: This 
standard provides test methods for determining the flammability of 
aerosols and gases. The standard provides additional information on the 
criteria used in classifying gases with regards to their flammability.
    [ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
 Appendix B.4--Oxidizing Gases
    [cir] ISO 10156: 2010, Gases and Gas Mixtures--Determination of 
Fire Potential and Oxidizing Ability for the Selection of Cylinder 
Valve Outlets, Third Edition, April, 2010: This consensus standard 
provides specific details of the methods used to determine flammability 
of a gas or gas mixture. The standard also provides methods for 
determining if a gas or gas mixture is more or less oxidizing than air 
under atmospheric conditions. The standard provides information on 
criteria that may be used for classifying gases and gas mixtures as 
flammable gases and may be used to select the appropriate gas cylinder 
valve outlet for the flammability classification.
    [ssquf] https://www.iso.org/store.html.
 Appendix B.14.2--Oxidizing Solids
    [cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport 
of Dangerous Goods, Manual of Tests and Criteria, Part III: This 
section of the standard provides detailed test methods for determining 
the potential of a solid substance to increase the burning potential or 
burning intensity of a combustible substance when the two are 
thoroughly mixed. The standard also provides schematic with criteria on 
classifying solid substances based on the oxidizing potential.
    [ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
 Appendix B.17.2--Desensitized Explosives
    [cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport 
of

[[Page 9696]]

Dangerous Goods, Manual of Tests and Criteria, Part V: This section of 
the Manual identifies criteria for classification of desensitized 
explosives, and addresses the proper storage of these substances. The 
standard provides testing criteria and guidance on classifying, 
storing, and properly transporting goods according to their physical 
hazards.
    [ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
    [cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport 
of Dangerous Goods, Manual of Tests and Criteria, Part II: This 
standard provides information on the definition of desensitized 
explosives, the test methods used to evaluate a substance's ability to 
suppress its explosive properties when thoroughly mixed as a homogenous 
liquid and provides the criteria used to classify these substances 
based on their desensitizing properties.
    [ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
 Appendix B.17.3--Desensitized Explosives
    [cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport 
of Dangerous Goods, Manual of Tests and Criteria, Part II: This 
standard provides information on the definition of desensitized 
explosives, the test methods used to evaluate a substance's ability to 
suppress its explosive properties when thoroughly mixed as a homogenous 
liquid and provides the criteria used to classify these substances 
based on their desensitizing properties.
    [ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
    The proposed inclusion of UN ST/SG/AC.10/30/Rev.6, UN 
Recommendations on the Transport of Dangerous Goods, Manual of Tests 
and Criteria, in some sections of appendix B (B.1, B.2, B.3, B.4, B.14, 
and B.17) would align with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060). However, an earlier version of UN ST/SG/AC.10 (Rev. 4) was 
incorporated by reference as part of the 2012 rulemaking and OSHA is 
not currently proposing to update all of the Rev. 4 references to Rev. 
6 as part of this rulemaking. OSHA requests comments on whether it 
should, in the final rule, update all of the existing references to UN 
ST/SG/AC.10/30 to Rev.6 or add Rev. 6 references to the existing Rev. 4 
references such that they would be alternative options for compliance.
    UN ST/SG/AC.10/Rev.4 is included in the proposed regulatory text as 
part of the revision to the structure of Sec.  1910.6(bb).
    Copies of the standards are available for purchase from the issuing 
organizations at the addresses or through the other contact information 
listed in Sec.  1910.6 for these private standards organizations. The 
UN documents are available at no cost through the contact information 
listed above. In addition, in accordance with Sec.  1910.6(a)(4), 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. Regulatory Text

    OSHA has proposed numerous revisions to the HCS regulatory text. 
The discussion of the proposed modifications is organized by paragraphs 
to the regulatory text with each modification/addition, and the reasons 
for and anticipated impact of each, described in detail below. 
Stakeholders can examine the redline strikeout version of the 
regulatory text at the OSHA HCS web page (https://www.osha.gov/dsg/hazcom/) or in the docket of this rulemaking (OSHA, 2020, Document ID 
0222).
Paragraph (a) Purpose
    Existing paragraph (a)(1) of the HCS states that the purpose of the 
standard 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. This provision 
currently explains that the requirements of the standard are intended 
to be consistent with the GHS Rev. 3. As the changes in this proposal 
would align the HCS with the GHS Revision 7, OSHA proposes to change 
the reference from Rev. 3 to Rev. 7.
Paragraph (b) Scope and Application
    The scope section of the HCS identifies the chemicals that are (and 
are not) covered by the standard. Existing paragraph (b)(6)(x) excludes 
nuisance particulates from the standard where the chemical manufacturer 
or importer can establish that they do not pose any physical or health 
hazard covered by the standard. OSHA proposes 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., 
hazard not otherwise classified (HNOC)) covered by the standard. This 
proposal would clarify that all hazards covered by the standard must be 
considered when evaluating nuisance particulates.
Paragraph (c) Definitions
    OSHA proposes to update three existing definitions and to add eight 
new terms and definitions to the HCS. In addition, the agency is 
proposing to eliminate one definition from the standard.
    OSHA is proposing to add a definition of the term Bulk Shipment to 
the standard. The addition of this definition supports proposed 
paragraph (f)(5)(ii), which clarifies labeling requirements for bulk 
shipments of hazardous chemicals. The proposed definition would state 
that ``bulk shipment'' means any hazardous chemical transported where 
the mode of transportation (vehicle) comprises the immediate container 
(e.g., contained in tanker truck, rail car, or intermodal container).
    OSHA is proposing to add the term Combustible Dust to the standard. 
In updating the HCS in 2012, OSHA did not include a definition of 
combustible dust because the agency was considering a combustible dust 
rulemaking and the UNSCEGHS was also considering combustible dust 
classification and communication issues (see 77 FR at 17705). However, 
OSHA has not promulgated a combustible dust standard. Since 2012, the 
UNSCEGHS has adopted a definition; the GHS 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'' (definition adopted from ISO/IEC 80079-20-2 
as referenced in UN GHS, 2017, Document ID 0060). OSHA has 
preliminarily determined that this definition is consistent with 
existing OSHA guidance on combustible dust hazards and proposes to 
adopt this definition (OSHA, 2020, Document ID 0190; OSHA, 2009, 
Document ID 0255). OSHA has several standards that use the term 
``combustible dust,'' but do not define the term (e.g., Sec.  1910.272, 
Grain Handling Facilities). OSHA believes the proposed definition of 
the term for the HCS is consistent with the use of that term in those 
other standards.
    OSHA is also proposing to revise the definition of exposure or 
exposed. The definition currently provides, 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. OSHA 
proposes to revise the definition to mean an employee is subjected in 
the course of employment to a ``hazardous chemical,'' rather than to 
``a chemical

[[Page 9697]]

that is a physical or health hazard,'' to clarify that the HCS covers 
the hazards of all hazardous chemicals, including those considered to 
be HNOCs.
    OSHA is proposing to include three new definitions for the terms 
Gas, Liquid, and Solid. The agency is proposing to include these terms 
to align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060). Although 
not included in the GHS, OSHA is proposing to add the temperature in 
equivalent degrees Fahrenheit and pressure in equivalent pounds per 
square inch (PSI) to the GHS definitions of gas and liquid because 
those measurements are more commonly used in the U.S.
    Consistent with the GHS, OSHA proposes to define gas as 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). 
Also consistent with the GHS, OSHA proposes to adopt the definition of 
liquid as a substance or mixture which at 1220F (50 [deg]C) has a vapor 
pressure of not more than 43.51 PSI (300 kPa (3 bar)), which is not 
completely gaseous at 680F (20 [deg]C) and at a standard pressure of 
101.3 kPa, and which has a melting point or initial melting point of 68 
0F (20 [deg]C) or less at a standard pressure of 14.69 PSI (101.3 kPa). 
Furthermore, in accordance with the GHS, OSHA is proposing to include 
the following as part of the definition of liquid: A viscous substance 
or mixture for which a specific melting point cannot be determined 
shall be subjected to ASTM D4359-90 (the Standard Test Method for 
Determining Whether a Material Is a Liquid or a Solid (2019)); 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, 2019). Finally, 
OSHA proposes to adopt the GHS definition of solid as a substance or 
mixture which does not meet the definitions of liquid or gas.
    Although OSHA did not include these terms in the 2012 update to the 
HCS, the agency is now proposing to include these definitions in order 
to improve clarity and ensure consistency in hazard communication both 
domestically and internationally. The agency anticipates that including 
these terms in the standard will clarify provisions under appendices B 
and D for classification of hazardous chemicals and preparation of 
SDSs. OSHA does not anticipate that these new definitions will impact 
other existing standards for construction or general industry. OSHA is 
requesting comments on its preliminary decision to include these 
definitions in this update.
    OSHA is proposing to update the definition of hazardous chemical to 
delete the reference to pyrophoric gas because OSHA is proposing to 
classify this hazard as a physical hazard in the flammable gas hazard 
class (see discussion of proposed revisions to appendix B.2) and it is 
no longer necessary to list it separately in the definition. 
Concomitantly, OSHA is proposing to delete the separate definition for 
pyrophoric gas.
    OSHA proposes to add a definition for immediate outer package to 
mean the first packaging enclosing the container of hazardous chemical. 
While all containers of chemicals must be labeled, as discussed in the 
Summary and Explanation for paragraph (f), below, OSHA is proposing 
revised labeling requirements for small containers. Proposed paragraph 
(f)(12) would relax labeling requirements for small containers, but 
would require 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.
    The agency is also proposing to update the definition of physical 
hazard to mean a chemical that is classified as posing one of the 
following hazardous effects: Explosive; flammable (gases, liquids, or 
solids); aerosols; oxidizer (liquid, solid or gas); 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 proposed definition also explicitly 
states that the criteria for determining whether a chemical is 
classified as a physical hazard are detailed in appendix B of the 
standard. The proposal would make two substantive changes to the 
current definition: (1) It would move the reference to aerosols out of 
the parenthetical following the word ``flammable''; and (2) it would 
add a reference to desensitized explosives. These proposed revisions 
are intended to reflect the proposed new hazard classes for aerosols 
and desensitized explosives in appendix B in accordance with the GHS 
Rev. 7. These changes are discussed in greater detail in the Summary 
and Explanation of appendix B.
    OSHA is proposing to add a definition of Physician or other 
licensed health care professional (PLHCP) to the standard. OSHA 
proposes to define this term 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. The new definition is 
necessary in light of OSHA's proposal to replace the phrase ``physician 
and nurse'' in paragraph (i), trade secrets 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 discussed in 
greater detail in the Summary and Explanation of paragraph (i). OSHA 
believes 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.
    OSHA is also proposing 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 
is proposing to use in paragraphs (f)(1) and (11) related to updating 
labels when new hazard information becomes available. OSHA notes that 
this definition is similar, but not identical to, the definition used 
by the U.S. Environmental Protection Agency's (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 if it is stored in an area where finished products are 
ordinarily held for shipment. OSHA is not proposing to include 
chemicals that are stored in an area where finished products are 
usually held (but not packaged and labeled) in the 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 is requesting comments on 
whether the proposed definition is appropriate for application to the 
HCS. OSHA is also interested in understanding whether the slight 
differences between OSHA's and EPA's definitions will pose any 
compliance issues for entities dealing with both OSHA and EPA labeling 
requirements. See the discussion of the proposed revisions to paragraph 
(f) for additional details.
Paragraph (d) Hazard Classification
    OSHA is proposing two changes to paragraph (d)(1). OSHA proposes to 
revise the second sentence of paragraph

[[Page 9698]]

(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. The 
language OSHA is proposing to add at the end of that sentence (``under 
normal conditions of use and foreseeable emergencies'') simply 
reiterates the scope language currently in paragraph (b)(2) and OSHA's 
longstanding position that hazard classification must cover the normal 
conditions of use and foreseeable emergencies. As OSHA explained in its 
compliance directive for the HCS (OSHA, 2015, Document ID 0007), for 
example, known intermediates, by-products, and decomposition products 
that are produced during normal conditions of use or in foreseeable 
emergencies must be addressed in the hazard classification.
    OSHA also proposes 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 believes this language is necessary because there has been some 
confusion about whether chemical reactions that occur during normal 
conditions of use must be considered during classification. The 
agency's intent has always been to require information on SDSs that 
would identify all chemical hazards that workers could be exposed to 
under normal conditions of use and in foreseeable emergencies (see 
paragraph (b)(2)). This issue has been raised, 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. While OSHA intends for the hazards 
created by the mixing of these two chemicals to be considered in 
classification, those hazards need only appear on the SDS (see appendix 
D to Sec.  1910.1200--Safety Data Sheets, section 3) and not on the 
label. For additional information, please see the Summary and 
Explanation for appendix D.
Paragraph (e) Written Hazard Communication Plan
    OSHA is proposing a minor editorial correction in paragraph (e)(4). 
OSHA has found 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. 
Notably, this error is reflected only in the print version of the CFR; 
the eCFR (www.ecfr.gov) is correct. OSHA proposes to fix this error so 
that the print and electronic versions of the standard are the same.
Paragraph (f) Labels and Other Forms of Warning
    Paragraph (f) of the HCS provides requirements for labeling. OSHA 
is proposing to modify paragraphs (f)(1), (5), and (11), and is also 
proposing a new paragraph (f)(12).
    Paragraph (f)(1), Labels on shipped containers, currently specifies 
what information is required on shipped containers of hazardous 
chemicals and also provides that HNOCs do not have to be addressed on 
the containers. OSHA proposes 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 believes this information is not 
appropriate on containers because it might confuse users about the 
immediate hazards associated with the chemical in the container. 
However, information on hazards resulting from a reaction with other 
chemicals under normal conditions of use is important for downstream 
users, and OSHA is not proposing 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 proposes to add the word ``distributor'' to the third 
sentence of paragraph (f)(1) to make it consistent with the first 
sentence.
    In new paragraph (f)(1)(vii), OSHA is proposing to add a 
requirement that the label include the date a chemical is released for 
shipment. The agency is proposing 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. Providing the 
date a chemical is released for shipment on the label would allow 
manufacturers and distributors to more easily determine their 
obligations when new hazard information becomes available.
    Paragraph (f)(5) specifies label requirements that apply to the 
transport of hazardous chemicals from workplace to workplace. OSHA 
proposes to add the heading ``Transportation'' to this paragraph and to 
add two new paragraphs to (f)(5) that specify requirements related to 
transportation of hazardous chemicals.
    OSHA is proposing to add new paragraph (f)(5)(ii) to address the 
transport of bulk shipments of hazardous chemicals (e.g.,, in tanker 
trucks or rail cars). 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 other technological or electronic means so that the 
information is immediately available in print to workers on the 
receiving end of the shipment. The proposed paragraph would codify 
policy from a 2016 guidance document that OSHA created jointly with 
DOT's Pipeline Hazardous Materials Safety Administration (PHMSA), with 
the intent of providing stakeholders with clarity for how to properly 
label bulk chemicals in transport (PHMSA, 2016, Document ID 0244). OSHA 
requests comments on whether it is appropriate to add proposed 
paragraph (f)(5)(ii) to the HCS and whether the addition of that 
paragraph would provide clarity regarding labeling of bulk chemical 
shipments.
    Under the current HCS, appendix C, paragraph C.2.3.3 provides that 
where a pictogram required by the 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, after learning that DOT updated its 
regulations to indicate that it does not consider the HCS pictogram to 
conflict with the DOT pictogram, OSHA no longer believes that having 
both pictograms will create confusion for workers handling the 
chemical. Accordingly, OSHA proposes to: (1) Delete the language 
currently in paragraph C.2.3.3 from appendix C; and (2) adopt new 
paragraph (f)(5)(iii) to provide that where a DOT pictogram appears on 
a label for 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 current standard, the flame pictogram on the OSHA-compliant 
label would be prohibited because the DOT label would contain the 
equivalent pictogram. The proposed rule would allow, but not require, 
the flame pictogram to appear on the OSHA-compliant label. This means 
chemical

[[Page 9699]]

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.
    Paragraph (f)(11) currently 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 ships. Therefore, OSHA proposes 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 proposed sentence also states that the chemical 
manufacturer or importer must provide the updated label for each 
individual container with each shipment. The purpose of this proposal 
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 (Kenyon, 2017, 
Document ID 0182). 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 (NGFA, 
2016, Document ID OSHA-2016-0005-0018; AFIA, 2016, Document ID OSHA-
2016-0005-0017).
    The act of relabeling 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 potential chemical exposures. Furthermore, OSHA believes re-labeling 
of sealed hazardous chemical containers is not a common practice in 
warehouses and that warehouses may lack the equipment necessary to 
relabel products in a safe and effective manner.
    OSHA has previously recognized the complexities involved with 
relabeling existing stock of hazardous chemicals. Following 
promulgation of the 2012 updates to the HCS, the HCS compliance 
directive (OSHA, 2015, 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 June 1, 2015, chemical manufacturers 
and importers of hazardous chemicals were required to ensure that each 
container was labeled with an HCS 2012-compliant label prior to 
shipping, and all distributors were generally required to ensure any 
chemicals shipped after December 1, 2015, were labeled in accordance 
with the 2012 updates to the HCS. OSHA used this enforcement policy as 
a basis for the proposed revisions to paragraph (f)(11).
    OSHA has preliminarily determined that the proposed changes to 
paragraph (f)(11) would adequately address issues with long 
distribution cycles while still ensuring chemical users receive the 
most current hazard information. OSHA invites comments on the proposed 
revisions to this paragraph. In particular, OSHA requests comments 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 is proposing a new paragraph, (f)(12), to address small 
container labeling. Currently, the HCS requires that all shipped 
containers be labeled with the information specified in paragraph 
(f)(1). The HCS, as updated in 2012, requires considerably more 
information on the label than the standard required previously; labels 
must include all hazards, as well as pictograms and precautionary 
statements. Many stakeholders have told OSHA that they have 
difficulties 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 (Watters, 2013, 
Document ID 0200; Collatz, 2015, Document ID 0174; Blankfield, 2017, 
Document ID 0170). In response to these concerns, through letters of 
interpretation and the HCS directive (OSHA, 2015, Document ID 0007; 
Watters, 2013, Document ID 0200; Collatz, 2015, Document ID 0174; 
Blankfield, 2017, Document ID 0170), 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. The 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. OSHA proposes to incorporate this practical 
accommodation into the standard in new paragraph (f)(12).
    OSHA is proposing that all of the 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 paragraph (f)(12)(ii)(A) through 
(E) would provide that labels on small containers that are less than or 
equal to 100 milliliter (ml) capacity must include, at minimum: Product 
identifier; pictogram(s); signal word; chemical manufacturer's name and 
phone number; and a statement that the full label information for the 
hazardous chemical is provided on the immediate outer package. 
Additionally, 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,

[[Page 9700]]

that same proposed paragraph would state that if no label is required, 
the container must bear, at minimum, the product identifier. For 
example, the product identifier (e.g., CAS 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 paragraph 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 believes that proposed paragraph (f)(12) would provide 
chemical manufacturers, importers and distributors with flexibility in 
labeling small containers. The proposed paragraph is consistent with 
the small packaging examples provided in the GHS Annex 7: Examples of 
Arrangements of the GHS Label Elements (UN GHS, 2016, Document ID 
0197), and would result in better alignment with Health Canada's 
Hazardous Product Regulations (HPR) small capacity container 
requirements (Health Canada, 2015, 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 
requests comments on the feasibility of the proposed small container 
labeling provisions. The agency also requests feedback about whether 
the proposed changes would improve safe handling and storage for 
chemicals in small containers.
Paragraph (g) Safety Data Sheets
    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 source for exposed employees, industrial hygienists, safety 
professionals, emergency responders, health care professionals, and 
other interested parties. While OSHA believes that information in SDSs 
has greatly improved with the standardized, 16-section format 
prescribed in the 2012 updates to the HCS, the agency is proposing two 
minor changes to paragraph (g) to ensure consistency and accessibility 
of the SDSs.
    The proposed revisions to paragraph (g) are confined to paragraphs 
(g)(2) and (10). The purpose of paragraph (g)(2) is to identify what 
information must be included on an SDS. The first part of existing 
paragraph (g)(2) states 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 is 
proposing to revise paragraph (g)(2) by removing the reference to 
preparing the SDS. The first part of the first sentence in paragraph 
(g)(2) would be revised to read simply that the chemical manufacturer 
or importer shall ensure that the SDS is in English. This is a 
technical clarification intended to ensure consistency with paragraph 
(g)(1).
    Paragraph (g)(10) addresses the form and storage of SDSs. The 
original intent of paragraph (g)(10) was to allow employers 
alternatives to SDSs within a plant site (see 48 FR 53337). 
Alternatives to SDSs, such as written operating procedures and manuals, 
are generally permitted. Existing paragraph (g)(10) also permits 
employers to design SDSs 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 chemicals. In any case, paragraph 
(g)(10) requires the employer to ensure that the required information 
is provided for each hazardous chemical and is readily accessible to 
employees. However, with the update to the HCS in 2012, OSHA changed 
the requirements of the SDS from a performance-oriented format to a 
standardized format. Standardizing the SDS format improved hazard 
communication by ensuring users could quickly find relevant information 
(see 77 FR 17596-98). Because SDSs now have a standardized format and 
are specific to individual hazardous chemicals, they are not permitted 
to be designed to cover groups of hazards, as currently provided in 
paragraph (g)(10). Therefore, OSHA is proposing 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. OSHA 
believes that this change would allow employers flexibility in how they 
keep SDSs in the workplace while also ensuring that the mandatory 16-
section SDS is maintained. The agency is requesting comments regarding 
whether this proposed revision would require stakeholders to make any 
significant changes to their current practices.
Paragraph (i) Trade Secrets
    This paragraph 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. OSHA is proposing three 
significant changes within paragraph (i)(1) and the paragraphs 
thereunder. First, OSHA is proposing to revise paragraph (i)(1) to 
allow for concentration ranges to be claimed as a trade secret and to 
specify that it is section 3 of the SDS from which trade secret 
information may be withheld.
    Second, OSHA is proposing new paragraph (i)(1)(iv), which would 
require that when an ingredient's exact concentration or concentration 
range is claimed as a trade secret, the SDS must provide the 
ingredient's concentration as a concentration range selected from a 
prescribed list of ranges. These ranges are in proposed paragraphs 
(i)(1)(iv)(A) through (M) as follows: (1) From 0.1% to 1%; (2) from 
0.5% to 1.5%; (3) from 1% to 5%; (4) from 3% to 7%; (5) from 5% to 10%; 
(6) from 7% to 13%; (7) from 10% to 30%; (8) from 15% to 40%; (9) from 
30% to 60%; (10) from 45% to 70%; (11) from 60% to 80%; (12) from 65% 
to 85%; and (13) from 80% to 100%. These ranges are consistent with 
those used in Canada, first described under the WHMIS 1988 Controlled 
Products Regulation (CPR) and re-implemented in 2018 under the HPR 
(Canadian Gazette II, 2018, Document ID 0101). Using the same 
concentration ranges as Canada, one of the U.S.'s major trading 
partners, is part of the two countries' efforts through the Regulatory 
Cooperation Council to align hazard communication to the greatest 
extent possible.
    OSHA has received numerous inquiries about the use of trade secrets 
for concentration ranges (Colau, 2017, Document ID 0098; Nelson, 2017, 
Document ID 0099). Although chemical manufacturers and importers are 
permitted to use concentration ranges rather than an exact percentage 
on the

[[Page 9701]]

SDS when there is batch-to-batch variability in the production of a 
mixture or for a group of substantially similar mixtures with similar 
chemical composition, OSHA does not currently allow trade secret status 
for a concentration range (see 77 FR 17731). However, in response to 
feedback from stakeholders who have indicated that there are instances 
where a concentration range is also a trade secret, OSHA has 
preliminarily determined it is appropriate to permit concentration 
ranges to be claimed as trade secrets as long as the ranges prescribed 
in proposed paragraphs (i)(1)(iv)(A) through (M) are used (Nelson, 
2017, Document ID 0099; Colau, 2017, Document ID 0098).
    Third, proposed new paragraph (i)(1)(v) would require that the 
concentration range used on the SDS be the narrowest range possible. 
This proposed paragraph would also provide that if the actual 
concentration range falls between 0.1% and 30% and does not fit 
entirely into one of the prescribed ranges in proposed paragraphs 
(i)(1)(iv)(A) through (G), a single range created by the combination of 
two applicable consecutive ranges between (i)(1)(v)(A) and (G) may be 
disclosed instead, provided that the combined concentration range does 
not include any range that falls entirely outside the exact range in 
which the ingredient is present. For example, a chemical manufacturer 
that wishes to claim the concentration of a specific ingredient (e.g., 
2.5%) as a trade secret would have to use the prescribed range in 
proposed paragraph (i)(1)(iv)(C) of 1% to 5%. If the ingredient is in 
the mixture at a concentration range of 0.9% to 2%, then the chemical 
manufacturer could combine the prescribed ranges in proposed paragraphs 
(i)(1)(iv)(B) and (C), resulting in a range of 0.5% to 5% on the SDS. 
If the ingredient is in the mixture at a concentration range of 5% to 
7%, the chemical manufacturer would have to use the range in proposed 
paragraph (i)(1)(iv)(D) of 3% to 7%, because it is narrower than the 
range in proposed paragraph (i)(1)(iv)(E) of 5% to 10%.
    OSHA is requesting comments on the proposed revisions to paragraph 
(i)(1). Specifically, the agency is interested in any experience 
stakeholders have had with developing SDSs using the prescribed 
concentration ranges and any concerns stakeholders have about using 
concentration ranges on SDSs. The agency is also requesting comments 
addressing the adequacy of hazard information provided by these ranges. 
Do these ranges provide sufficient information for downstream chemical 
manufacturers to conduct hazard classifications? Are the ranges listed 
in proposed paragraphs (i)(1)(iv)(A) through (M) too wide (should they 
be narrowed)? Should OSHA allow combinations among all ranges (e.g., 
(i)(1)(v)(A) through (M)) or should the allowance for combining ranges 
be even more restrictive than proposed (e.g., (i)(1)(v)(A) through 
(E))?
    OSHA is also proposing other changes in paragraph (i) to reflect 
the proposal to permit concentration ranges to be claimed as trade 
secrets and to adopt the ``PLHCP'' terminology in lieu of references to 
``physician or nurse.'' See discussion of proposed changes to paragraph 
(c), Definitions, where OSHA explains that it is proposing to replace 
the phrase ``physician and nurse'' with ``PLHCP'' to be consistent with 
other OSHA standards and to better reflect current medical practices. 
The specific changes OSHA is proposing are as follows:
     OSHA is proposing to revise paragraph (i)(1)(iii) to 
change ``percentage'' to ``concentration or concentration range.''
     OSHA is proposing to move existing paragraph (i)(1)(iv) to 
paragraph (i)(1)(vi) and to change ``percentage'' to ``exact 
concentration or concentration range.''
     In paragraph (i)(2), OSHA is proposing to change 
``physician or nurse'' to ``PLHCP'' and to replace ``percentage of 
composition'' with ``concentration or concentration range.''
     OSHA is proposing to revise paragraph (i)(3) to change 
``percentage composition'' to ``exact concentration or concentration 
range'' and to change the parenthetical from ``(i.e., physician, 
industrial hygienist, toxicologist, epidemiologist, or occupational 
health nurse)'' to ``(e.g., PLHCP, industrial hygienist, toxicologist, 
or epidemiologist).''
Paragraph (j) Dates
    OSHA is proposing to implement the revised provisions over a two-
year phase-in period. OSHA proposes that the revisions become effective 
60 days after the publication date (paragraph (j)(1)) and that chemical 
manufacturers, importers, and distributors evaluating substances comply 
with all modified provisions of the HCS no later than one year after 
the effective date (paragraph (j)(2)). OSHA also proposes that chemical 
manufacturers, importers, and distributors evaluating mixtures comply 
with all modified provisions no later than two years after the 
effective date (paragraph (j)(3)).
    Proposed paragraph (j) would replace the regulatory text currently 
in paragraph (j), as the dates specified in existing paragraph (j) have 
all passed. This proposed paragraph is based in part on stakeholder 
comments and the agency's experience implementing the 2012 updates to 
the HCS. In 2012, OSHA did not stagger the compliance dates for 
substances and mixtures; however, OSHA believes that such a tiered 
approach may ease the compliance burden for manufacturers of mixtures 
that may rely on the hazard information in the SDSs from their 
ingredient suppliers to update the labels and SDSs for the mixtures. 
The changes OSHA is proposing in this update are far less complicated 
than the 2012 revision and would result in no change in hazard 
classification for the vast majority of chemicals. Additionally, the 
proposed update to paragraph (f)(11) addressing relabeling requirements 
for chemicals that have been released for shipment would also reduce 
the need for a lengthier implementation period. OSHA is requesting 
comments regarding the adequacy and appropriateness of the proposed 
compliance dates and on the feasibility of implementing a tiered 
compliance approach for substances and mixtures.

C. Appendix A

    OSHA is proposing to update appendix A in several respects. The 
proposed changes 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. 
OSHA preliminarily concludes that all of the proposed changes to 
appendix A will improve classification and communication of hazards and 
thus better protect workers. Many of the proposed changes would align 
the HCS with the GHS Rev. 7. Aligning the HCS with the GHS would ease 
compliance burdens for U.S. stakeholders who must also comply with 
international requirements for hazard classification and communication.
    OSHA is providing a redline strikeout version of appendix A, which 
reflects all of OSHA's proposed revisions, in the docket and on the 
OSHA website (OSHA HCS Redline, 2020, Document ID 0222; https://www.osha.gov/dsg/hazcom/). This will allow interested parties to view 
all of the proposed changes in context. OSHA strongly encourages 
stakeholders to review that document in conjunction with the discussion 
of the proposed revisions below, as the discussion below does not fully 
describe all of the non-substantive or editorial changes OSHA is 
proposing.

[[Page 9702]]

Revisions to Health Hazards in Appendix A
General Classification Considerations
    In Paragraph A.0.1, OSHA proposes to add a note from Paragraph 
1.3.3.1.3 of the GHS Rev. 7 (UN GHS, 2017, Document ID 0060), 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 
now believes that this note is useful to align with the GHS and has 
added this note as proposed A.0.1.3. Including this provision would 
clarify that manufacturers and importers must consider the hazards of 
all classified components when classifying chemicals. This would help 
ensure accurate classification of chemicals and therefore improve 
protections for workers.
    OSHA also proposes to modify the introduction of paragraph A.0.4.1 
to include mandatory language. The current text indicates that the 
sequence in the process of classification of mixtures is recommended. 
OSHA proposes to revise A.0.4.1 to read ``Except as provided in 
A.0.4.2, the process of classification of mixtures is based on the 
following sequence'' to specify that this process is mandatory.
Acute Toxicity--(Appendix A.1)
    In appendix A.1, OSHA proposes 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 current definition refers 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 4 hours.) This change is being proposed to 
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2016, Document ID 0131).
    OSHA also proposes to revise the classification criteria for 
substances in A.1.2.1 to note that 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. This change is being 
proposed to align with classification criteria in the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2016, Document ID 0131).
    OSHA is also proposing slight revisions to Table A.1.1, ``Acute 
toxicity hazard categories and acute toxicity estimate (ATE) values 
defining the respective categories'', to align with the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2016, Document ID 0131). The GHS 
presents the ATE range in Table A.1.1 using the term ``ATE'' to express 
the range, while the HCS currently uses the term ``AND.'' Therefore, 
OSHA proposes to change the ``AND'' in the acute toxicity estimate 
(ATE) ranges to ``ATE'' to align with the GHS Rev. 7. This modification 
would not change the classification criteria itself, but would be more 
technically accurate and consistent with the way the table is expressed 
in the European Commission's (EC) Classification, Labelling, and 
Packaging of Substances and Mixtures (CLP) regulation (ECHA, 2017, 
Document ID 0256).
    In paragraph A.1.2.3, OSHA proposes to include a new sentence at 
the end of the paragraph to clarify that both data from animal tests 
and human studies should be considered in evaluating acute toxicity. 
The new text states that 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. 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 (UN GHS, 2016, Document ID 0131). 
OSHA is proposing these changes to paragraph A.1.2.3 to align with the 
GHS Rev. 7.
    OSHA also proposes a new paragraph A.1.2.4, which is intended to 
correspond to Chapter 3.1, (paragraph 3.1.2.6.5) in the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060). This proposed paragraph would provide 
that in addition to classification for inhalation toxicity, if data are 
available that indicate that the mechanism of toxicity was corrosivity 
of the substance or mixture, the classifier must consider whether the 
chemical is corrosive to the respiratory tract. This proposed paragraph 
would clarify that the hazard corrosive to the respiratory tract is 
covered under the HCS. OSHA did not explicitly include the corrosive to 
the respiratory tract hazard in the HCS in 2012, but explained in OSHA 
3844: Hazard Communication: Hazard Classification Guidance for 
Manufacturers, Importers and Employers (OSHA, 2016, Document 0008) that 
this hazard should be considered during classification. 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 
indicates acute inhalation toxicity with corrosion of the respiratory 
tract and the effect does not lead to lethality, then the hazard may be 
addressed in the Specific Target Organ Toxicity hazard classes (see 
appendices A.8 and A.9). OSHA is including these clarifications in 
proposed A.1.2.4.1 and A.1.2.4.2, but is modifying the ``may'' language 
from the guidance to ``must'' language to ensure that corrosive to the 
respiratory tract is appropriately considered during the classification 
process.
    In Figure A.1.1 and paragraph A.1.3.6.2.2, OSHA proposes to correct 
the cross-reference from A.1.3.6.2.3 to A.1.3.6.2.4. OSHA also proposes 
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 1 percent, 
paragraph A.1.3.6.2.3 currently requires a statement that ``X'' percent 
of a mixture consists of ingredient(s) of unknown toxicity on the label 
and SDS. OSHA proposes to revise this paragraph to require the 
statement to differentiate by route of exposure. For example, the 
statement(s) could read, ``x % of the mixture consists of ingredient(s) 
of unknown acute oral toxicity'' or ``x % of the mixture consists of 
ingredient(s) of unknown acute dermal toxicity.'' Given that it is 
possible to have unknown ingredients for more than one relevant route 
of exposure (e.g., oral, dermal, inhalation), differentiating the 
statement by route would be helpful to chemical users. This proposed 
change would align with paragraph 3.1.3.6.2.2 in the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2010, Document 0089).
    OSHA also proposes to delete the second paragraph in A.1.3.6.2.3 
because it is duplicative of the first paragraph.
Skin Corrosion/Irritation and Serious Eye Damage/Eye Irritation--
(Appendices A.2 and A.3)
    OSHA is proposing more extensive revisions to the sections on skin 
corrosion/irritation and serious eye

[[Page 9703]]

damage/irritation (appendices A.2 and A.3) than it is proposing for the 
other health hazard sections in appendix A of the HCS. These two 
sections correspond to Chapters 3.2 and 3.3 in the GHS. The UNSCEGHS, 
in its 16th Session, 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 (UN GHS, 2016, Document 0131). 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. The working group 
has since completed its efforts to clarify the skin corrosion/
irritation and serious eye damage/irritation chapters. The work was 
approved by the UNSCEGHS in 2012 (UN GHS, 2012, Document ID 0212). 
Accordingly, OSHA is now proposing to revise appendices A.2 and A.3 to 
incorporate all of the modifications that were made to the GHS skin 
corrosion/irritation and serious eye damage/irritation chapters agreed 
to by the UNSCEGHS up to and including the GHS Rev. 7. This would 
ensure that OSHA remains aligned with the GHS. OSHA is not proposing 
any completely new provisions for the HCS; however, OSHA is proposing 
to revise the two appendices to align the language and format of the 
HCS with the GHS Rev. 7.
    In appendix A.2, skin corrosion/irritation, OSHA proposes to modify 
paragraph A.2.1.2 to clarify the sequence in which data should be 
evaluated when classifying for skin corrosion/irritation using a tiered 
evaluation approach. The proposal would align the language in this 
paragraph with the tiered approach in Figure A.2.1. The first tier is 
existing human data, followed by existing animal data, followed by in 
vitro data, and then other sources of information.
    The proposed changes to the skin corrosion/irritation criteria in 
paragraph A.2.2 are mainly editorial in nature. The classification 
criteria would remain the same, but the presentation of the information 
would be rearranged in a clearer, more logical fashion. In addition, 
OSHA is proposing new paragraph A.2.2.2.2, which is intended to provide 
classifiers with factors to be taken into consideration when evaluating 
irritant responses.
    The proposed changes in paragraph A.2.3 are also mainly editorial 
in nature. The criteria would remain the same, but clarifying text 
would be introduced into the section and the criteria would be 
presented in a more logical sequence.
    OSHA also proposes 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 would align with the note to Table 3.2.3 in the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0132), and OSHA 
believes that it provides useful information for classifiers.
    Figure A.2.1, ``Tiered evaluation of skin corrosion and irritation 
potential'', would remain largely the same under OSHA's proposed 
revisions to the appendix. However, OSHA is proposing to revise the 
title to ``Tiered evaluation for skin corrosion and irritation.'' OSHA 
is also proposing to revise Steps 1a, 1b, and 1c of Figure A.2.1 to 
clarify that the parameter being evaluated is existing human or animal 
skin corrosion/irritation data. In addition, OSHA is proposing 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 is also proposing some revisions to the 
footnotes of Figure A.2.1.
     In proposed footnote (1), OSHA is proposing to revise the 
current footnote to include an additional sentence indicating that 
although human data from accident or poison center databases can 
provide evidence for classification, absence of incidents is not itself 
evidence for a not classified determination. In addition, the reference 
to evidence from ethically-conducted human clinical studies would be 
removed. The text indicating that there is no internationally accepted 
test method for human skin irritation testing would also be removed.
     In proposed footnote (3), OSHA is proposing to revise the 
existing note to exclude the examples currently provided.
     In proposed footnote (6), OSHA is proposing to revise the 
current note to clarify that all available information on a substance 
must (instead of should) be considered in making a determination based 
on the total weight of evidence. OSHA is also proposing a new sentence 
at the end of the footnote to indicate that negative results from 
applicable validated skin corrosion/irritation in vitro tests are 
considered in the total weight of evidence evaluation.
    In paragraph A.2.4, OSHA is proposing to include in A.2.4.1.1 
language stating that the tiered approach must be taken into account 
when evaluating mixtures. In addition, a new paragraph A.2.4.1.2 is 
proposed to indicate that when considering testing of mixtures, 
classifiers must use the tiered approach to help ensure an accurate 
classification, as well as to avoid unnecessary animal testing. This 
proposed paragraph also indicates 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 further 
evaluation may be necessary.
    In Table A.2.4, ``Concentration of ingredients of a mixture for 
which the additivity approach does not apply, that would trigger 
classification of the mixture as hazardous to skin,'' OSHA proposes to 
delete the phrase ``for which additivity does not apply'' where it 
appears in the text of the table in order to reduce redundancy, as that 
language is already included in the title of the table. However, OSHA 
is proposing to modify the title of Table A.2.4 from ``for which 
additivity does not apply'' to ``when additivity does not apply'' to be 
consistent with the GHS Rev.7 (UN GHS, 2017, Document ID 0060).
    In appendix A.3, serious eye damage/eye irritation, OSHA proposes 
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 proposal would 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.
    The changes OSHA is proposing 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 presentation of the information would be rearranged and additional 
headings would be included to provide a clearer, more logical sequence. 
All of these proposed changes would conform with the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2012, Document 0132).
    Proposed paragraph A.3.2 provides a summary of the classification 
criteria for substances that is provided in Tables A.3.1 and A.3.2. In 
addition, proposed paragraph A.3.3.6 is a reorganization of existing 
paragraphs A.3.3.3 and A.3.3.4.

[[Page 9704]]

It would provide guidance on using the tiered approach and making 
weight of evidence decisions and also indicates a preference for not 
conducting new animal tests.
    Under OSHA's proposed revisions, Figure A.3.1, ``Tiered Evaluation 
for serious eye damage and eye irritation'', currently titled 
``Evaluation strategy for serious eye damage and eye irritation'', 
would remain largely the same. However, as in Figure A.2.1, OSHA is 
proposing 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 is proposing 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 is also proposing modifications to the footnotes of Figure 
A.3.1 to reflect the most recent test methods.
     In proposed footnote (3), OSHA is proposing to include an 
additional sentence 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.
     In proposed footnote (4), OSHA is proposing to include 
OECD Test Guideline 460 (Fluorescein leakage (FL) as an additional 
example of an internationally accepted, scientifically validated test 
method for identifying eye corrosives and severe irritants. OSHA is 
also proposing 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.
     In proposed footnote (6), OSHA is proposing to revise 
existing language 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 
is proposing to add two new sentences at the end of the footnote to 
indicate that the total weight of evidence, including information on 
skin irritation, may lead to classification for eye irritation and that 
negative results from applicable scientifically validated in vitro 
tests are considered in the total weight of evidence evaluation.
    In paragraph A.3.4, OSHA is proposing several minor editorial 
changes to ensure consistency in the terminology used. For example, 
OSHA is proposing to use the term ``serious eye damage'' (rather than 
``eye corrosion'') throughout the text to reflect the name of the 
hazard class.
Germ Cell Mutagenicity--(Appendix A.5)
    OSHA is proposing to add a definition for germ cell mutagenicity in 
A.5.1.1 explaining that 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. OSHA is proposing this definition to align with the GHS Rev. 7 
(UN GHS, 2017, Document ID 0060; UN GHS, 2016, Document ID 0131). 
Because of this new paragraph, the subsequent numbering of existing 
paragraphs in A.5.1 would be adjusted accordingly.
    In A.5.4, Examples of scientifically validated test methods, 
paragraph A.5.4.2, OSHA proposes 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. This change is consistent 
with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2014, 
Document 0087) and ensures that hazard classifications are being 
conducted with the most current scientific principles.
Reproductive Toxicity--(Appendix A.7)
    In appendix A.7, Reproductive toxicity, OSHA proposes to revise the 
``effects on or via lactation'' hazard category classification criteria 
to align with OSHA publication 3844 Hazard Classification Guidance for 
Manufacturers, Importers and Employers (OSHA 3844, 2016, Document 
0008). During the development of the guidance document, it became 
apparent to OSHA that there were issues with regard to the 
classification criteria in existing Figure A.7.1(b). The hazard 
category for effects on or via lactation captures two separate effects:
    i. Substances that can interfere with lactation; and
    ii. substances and their metabolites that may be transmitted 
through breast milk to children in amounts sufficient to cause concern 
for the health of the breast feeding child.
    However, the current criteria do not adequately distinguish between 
these two separate effects. The first issue has both grammatical and 
substantive aspects and is found in the second sentence of Figure 
A.7.1(b), which currently reads:
    ``Chemicals that are absorbed by women and have been shown to 
interfere with lactation or that may be present (including metabolites) 
in breast milk in amounts sufficient to cause concern for the health of 
a breastfed child, shall be classified to indicate this property 
hazardous to breastfed babies.''
    The italicized phrase is not grammatically correct and is also not 
correct as a matter of substance because it ignores the effects on 
lactation. As such, OSHA proposes to delete the text to indicate this 
property ``hazardous to breastfed babies.'' In addition, the categories 
of evidence currently listed in paragraphs (a) through (c) of Figure 
A.7.1(b) all provide evidence for effects via lactation rather than 
effects on lactation. To be more accurate, and to avoid confusion on 
how to apply the criteria for effects on lactation, OSHA proposes to 
modify the third sentence in the Figure to read: ``Classification for 
effects via lactation shall be assigned on the basis of:'' These 
proposed changes would not affect the classification of substances or 
mixtures as reproductive toxicants; however, they would be more 
accurate and provide more clarity for classifiers.
    OSHA proposes 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 is proposing a correction to the top left heading from 
``ingredients classified as'' to ``ingredient classified as.'' OSHA 
believes that the use of the word ``ingredients'' in this context may 
be confusing, as it may suggest that the additivity principle should be 
applied. Therefore, OSHA is proposing this change for clarity. These 
proposed modifications in appendix A.7 are consistent with the GHS Rev. 
7 (UN GHS, 2017, Document ID 0060; UN GHS, 2014, Document ID 0221).
Specific Target Organ Toxicity-Single Exposure--(Appendix A.8)
    In appendix A.8, OSHA proposes to make a correction to paragraph 
A.8.1.6 to correctly name the hazard class as ``specific target organ 
toxicity--single exposure'' instead of ``specific organ systemic 
toxicity single exposure.'' Also, in paragraph A.8.2.1.7.3, OSHA 
proposes to delete the erroneous inclusion of the second use of the 
word ``evidence'' in the second sentence.
    OSHA proposes to include the concept of ``relevant ingredient'' 
when classifying mixtures containing Category 3 ingredients using the 
additivity approach. Under the HCS, as updated in

[[Page 9705]]

2012, the additivity principle was introduced in paragraph A.8.3.4.5. 
However, a ``relevant ingredient'' for this procedure had not been 
established. Proposed new paragraph A.8.3.4.6 would provide that in 
cases where the additivity approach is used for Category 3 ingredients, 
the ``relevant ingredients'' of a mixture are those which are present 
in concentrations >=1% (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 <1% is still relevant when 
classifying the mixture for respiratory tract irritation or narcotic 
effects. This proposed paragraph would align with the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2014, Document 0221).
Aspiration Hazard--(Appendix A.10)
    The proposed changes to appendix A.10 would provide clarification 
on the classification criteria for mixtures when data are available for 
all ingredients or only for some ingredients. OSHA is proposing 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, a new heading, 
``Category 1,'' is proposed as new paragraph A.10.3.3.2. Proposed 
A.10.3.3.2.1 and A.10.3.3.2.2 would clarify that the principle of 
additivity applies in appendix A.10, but OSHA is not proposing any 
substantive changes to the classification criteria. These proposed 
changes would align with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060; UN GHS, 2014, Document 0221).
Changes to Definitions and Terminology, Clarification of Mandatory 
Requirements, and Corrections
Definitions
    OSHA proposes to update appendix A to include changes to the health 
hazard definitions to reflect those adopted by the GHS Rev. 7 (UN GHS, 
2017, Document ID 0060; UN GHS, 2016, Document ID 0131). Since OSHA 
revised the HCS in 2012, the UNSCEGHS has revised all of the health 
hazard definitions in the GHS. These modifications to the health hazard 
definitions were incorporated as a result of the work of the UNSCEGHS 
Practical Classification Issues working group. The scope of the working 
group is to clarify the GHS classification criteria, as appropriate, 
and to provide working examples to illustrate application of the 
criteria. 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 is proposing to adopt all of the 
revised health hazard definitions from the GHS Rev. 7 in appendix A, as 
well as corresponding changes to text throughout the appendix. For 
example, in some cases OSHA is proposing to remove OECD test guidelines 
from definitions and to move them to paragraphs outlining 
classification criteria. The health hazard definitions that OSHA is 
proposing in appendix A are:
     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 exposure to a substance or mixture.
     Skin irritation refers to the production of reversible 
damage to the skin occurring after 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.
     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.
     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.
     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.
     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.
Terminology Issues
    The HCS is currently somewhat inconsistent in the way the terms 
``hazard category'' and ``toxicity category'' are used throughout 
appendix A. In some cases the terms are used interchangeably, while in 
other instances the terms are intended to have different meanings. OSHA 
has reviewed appendix A and is proposing revisions to ensure that these 
terms are used appropriately and consistently. As such, OSHA proposes 
to delete the term ``toxicity category'' and replace it with ``hazard 
category'' in various places, including paragraphs A.0.5, A.1, A.8, 
A.9, and A.10. These proposed changes would align with the GHS Rev. 7 
(UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document 0084).
Mandatory Language
    OSHA is proposing to update a number of provisions in appendix A to 
make it clear that those provisions are mandatory. For example, OSHA 
proposes to change the term ``should'' to ``must'' in paragraph 
A.3.4.3.3. The change would 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.
Corrections
    OSHA proposes 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. OSHA proposes

[[Page 9706]]

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. 
Thus, OSHA also proposes 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. In addition, 
OSHA proposes to correct the cross-reference from A.1.3.6.2.3 to 
A.1.3.6.2.4 in Figure A.1.1 and paragraph A.1.3.6.2.2.

D. Appendix B

    OSHA is proposing a number of changes to appendix B. First, since 
the HCS was aligned with the GHS in 2012, new physical hazard classes 
or hazard categories have been added to the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060). OSHA proposes to adopt those additions. Second, the 
GHS Rev. 7 (UN GHS, 2017, Document ID 0060) contains several updates 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 is proposing to update 
consensus standards and testing methods referenced in appendix B in 
accordance with the GHS Rev. 7 to ensure that data considered for 
classification incorporate updated scientific principles. Third, OSHA 
is proposing 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 proposed changes are 
discussed below and would align the HCS with the GHS while improving 
the classification and communication of hazards \59\ and maintaining or 
enhancing worker safety and health. Additionally, as noted elsewhere, 
aligning the HCS with the GHS would ease compliance burdens for U.S. 
stakeholders that must also comply with international requirements for 
hazard classification and communication.
---------------------------------------------------------------------------

    \59\ Specific changes to the hazard and precautionary statements 
are discussed below in the section on appendix C.
---------------------------------------------------------------------------

    OSHA is also proposing to make a limited number of changes to 
appendix B that arise out of its implementation of the HCS, as updated 
in 2012. These changes, explained below, would clarify compliance 
requirements. OSHA believes that all of these proposed changes maintain 
existing safety and health protections while easing or having no effect 
on the compliance burdens for regulated entities.
    Finally, OSHA explains below that it is not proposing to 
incorporate one update reflected in the GHS Rev. 7 because that 
particular update is inconsistent with the scope of the HCS.
    OSHA is providing a redline strike out version of appendix B, which 
reflects all of OSHA's proposed revisions, in the docket and on the 
OSHA website (OSHA, 2020, Document ID 0222; https://www.osha.gov/dsg/hazcom). This will allow interested parties to view all of the proposed 
changes in context. OSHA strongly encourages stakeholders to review 
that document in conjunction with the discussion of the proposed 
revisions below, as the discussion below does not fully describe all of 
the non-substantive or editorial changes OSHA is proposing.
Explosives--(Appendix B.1)
    OSHA is proposing a few minor amendments to appendix B.1, 
Explosives. The first change that OSHA is proposing involves a 
clarification to the classification criteria for Division 1.6 
explosives in B.1.2(f). Under the GHS 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 (UN GHS, 2009, Document ID 0085). The 
GHS Rev. 7 (UN GHS, 2017, Document ID 0060) states that the criteria is 
met if the article [``item'' in the HCS] ``predominantly'' contains 
extremely insensitive detonating chemicals. OSHA is proposing to make 
the same change to paragraph B.1.2(f) of appendix B in the HCS. 
Changing the criteria from containing ``only'' extremely insensitive 
detonating chemicals to ``predominantly'' containing extremely 
insensitive detonating chemicals is more technically accurate and 
better aligns with the guidance in test series 7 in the UN Manual of 
Tests and Criteria (UN TDG, 2016, Document ID 0151). OSHA believes that 
consistency in the use of terms will reduce confusion for chemical 
manufacturers or importers when classifying explosives.
    OSHA is also proposing to add two notes from the GHS (UN GHS, 2017, 
Document ID 0060) to appendix B, paragraph B.1.3.1, that are related to 
the addition of the desensitized explosives hazards class (proposed 
appendix B.17), which is discussed later in this document. The first 
new note OSHA is proposing to add (Note 2) would provide that 
explosives for which explosive properties have been suppressed or 
reduced must be classified as desensitized explosives. The second new 
note OSHA proposes (Note 3) would provide 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. 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).
Flammable Gases--(Appendix B.2.)
    OSHA is proposing several changes to the Flammable Gases hazard 
class (appendix B.2). Most significantly, OSHA is proposing 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. These proposed changes would provide 
more detailed information about the flammable gas hazards and track 
changes made in the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) since 
OSHA updated the HCS in 2012. These proposed changes would allow 
downstream users to have a better understanding of the severity of the 
hazards associated with flammable gases. Downstream users could then 
use this information to take appropriate precautions or determine if a 
substitute chemical is less hazardous.
    The HCS currently lists two categories for flammable gases--
Category 1 (Extremely flammable) and Category 2 (flammable)--that are 
based on the percentage of the gas in a mixture with air that is 
ignitable and on ranges of flammability in air. In practice, with the 
current criteria, almost all flammable gases (except ammonia and methyl 
bromide, which are treated separately) are classified as Category 1. 
This means that, for hazard identification and communication purposes, 
no distinctions are being drawn between gases that exhibit a wide 
spectrum of flammable properties. OSHA has preliminarily concluded that 
Category 1

[[Page 9707]]

is too broad and can lead downstream users to choose a chemical without 
realizing that an alternative choice is actually less flammable. For 
example, 2,3,3,3-Tetrafluoropropene is a non-ozone depleting 
refrigerant which ignites less rapidly or violently than some other 
flammable gases. Many of these types of gases were developed as a 
result of the Montreal and Kyoto protocols, international treaties 
intended to phase out gases that are ozone depleting (UN GHS, 2016, 
Document ID 0138). However, with the current classification system, 
propane, which has a rapid, explosive ignition with a burn velocity of 
46 cm/s, and 2,3,3,3-Tetrafluoropropene (R-1234yf), which has a slow, 
weak ignition, with a burn velocity of 1.5 cm/s, would both be 
classified as Category 1 gases, thus making it appear that the two 
gases are equally flammable when in fact 2,3,3,3-Tetrafluoropropene is 
considerably less flammable (UN GHS, 2016, Document ID 0138).
    OSHA and DOT actively participated in the UN negotiations (joint 
informal working group) in 2015 to ensure that flammable gases are 
properly evaluated, classified and communicated. The joint informal 
working group activities included identifying, gathering, and reviewing 
data on ``less flammable'' gases, including the conduct of numerous 
burning velocity tests using approved test methods, as well as tests to 
demonstrate ignition behavior, flame propagation, and the speed of the 
flame front (UN GHS, 2016, Document ID 0254).
    The revised classification criteria in Table 2.2.1 in Chapter 2.2 
of the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) reflect 
recommendations made by the joint informal working group. The joint 
informal working group agreed that all flammable gases currently 
classified as Category 1 flammable gases should remain so. This 
decision allows the transport classification and communication scheme 
to remain the same. However, the joint informal working group agreed 
that Category 1 should be separated into two sub-categories, Category 
1A and Category 1B, when data is available on burning velocity and 
lower flammability limit. This separation allows for more precise 
classification of chemicals and more appropriate communication of the 
hazards associated with flammable gases.
    This proposed approach for classifying flammable gases is also 
consistent with the approach described in ANSI/ASHRAE Standard 34-
2013--Designation and Safety Classification of Refrigerants (ANSI/
ASHRAE, 2013, Document ID 0160). The ANSI/ASHRAE standard allows 
refrigerant gases (which can be category 1A or 1B) to be classified 
based on both the lower flammability limit and burning velocity (see 
Figure 6.1.4 and Section 6.1.3.2.1 (ANSI/ASHRAE, 2013, Document ID 
0160). OSHA's proposed cut-off for the burning velocity for category 1A 
and 1B chemicals is the same as that in the ASHRAE standard. Therefore, 
the proposed approach is consistent with accepted scientific principles 
and industry norms.
    OSHA has preliminary concluded that the classification scheme in 
Table 2.2.1 of the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) 
maintains safety for workers while allowing for more precise hazard 
classification and communication. Therefore, OSHA is proposing to 
replace Table B.2.1 of the HCS with the criteria from Table 2.2.1 in 
the GHS Rev. 7 (UN GHS, 2017, Document ID 0060). The only modification 
that OSHA proposes making to the GHS Table 2.2.1 is to add units of 
measurement used in the United States (e.g., degrees Fahrenheit). Under 
the proposed new table, all flammable gases that are currently 
classified as Category 1 flammable gases would be classified as 
Category 1A, unless data on flammability limit or fundamental burning 
velocity indicates that the gas should be classified as Category 1B. 
For a gas to be classified in Category 1B, data would have to show that 
its lower flammability limit is more than 6% by volume in air or its 
fundamental burning velocity is less than 10 cm/s; in addition, the gas 
could not be either pyrophoric or chemically unstable. Since the HCS 
does not require testing, the data required to classify a gas as a 
Category 1B flammable gas could be obtained from literature. However, 
if data is lacking in the literature, then testing would be necessary 
to establish that a newly-developed flammable gas qualifies for 
classification as a Category 1B flammable gas. The joint informal 
working group compiled a list of data available on burning velocity and 
flammability limits for pure flammable gases (OSHA, 2017, Document ID 
0164).
    When OSHA revised the HCS in 2012, pyrophoric gases were not 
classified under the GHS, Rev. 3 (UN GHS, 2009, Document ID 0085). 
Therefore, to ensure that the hazards of pyrophoric gases would 
continue to be covered and communicated, OSHA maintained the approach 
taken in the HCS starting in 1994. 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). While OSHA retained the definition for ``pyrophoric gas'' when 
it updated the HCS in 2012, the agency explained it also intended to 
continue to work with the UNSCEGHS to add the pyrophoric gas hazard to 
the GHS, along with two other hazards that OSHA covered under the HCS 
but that were not classified under the GHS: Simple asphyxiants and 
combustible dust (77 FR 17704). Since OSHA revised the HCS in 2012, the 
UNSCEGHS updated the criteria for flammable gases to include pyrophoric 
gases (UN GHS, 2014, Document ID 0086; UN GHS, 2017, Document ID 0060). 
The UNSCEGHS agreed that pyrophoric gases, as well as chemically 
unstable gases, should always be classified as Category 1A flammable 
gases because of the nature of these two types of gases; 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. Under the GHS Rev. 7 
(UN GHS, 2017, Document ID 0060), pyrophoric gases and chemically 
unstable gases are both classified as Category 1A. OSHA preliminarily 
agrees with this decision and proposes incorporating it into appendix 
B.2.
    If, as proposed, OSHA adds pyrophoric gases as a sub-category of 
flammable gases in appendix B.2, and, as proposed, includes a 
definition of pyrophoric gas in appendix B.2., it would no longer be 
necessary to include these gases as part of the definition of 
``hazardous chemical'' or to include a definition for ``pyrophoric 
gas'' in Sec.  1910.1200(c). Therefore, OSHA proposes to delete those 
terms in Sec.  1910.1200(c). OSHA also proposes to incorporate the 
definition of ``pyrophoric gas'' found in the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060), in paragraph B.2.1. OSHA currently defines 
pyrophoric gas as a chemical in the gaseous state that ``will ignite'' 
spontaneously in air at a temperature of 130 [deg]F (54.4 [deg]C) or 
below. The GHS Rev. 7 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 (UN GHS, 2017, Document ID 0060). The 
change in the definition from a gas that ``will ignite'' to a gas that 
is ``liable to ignite'' was made because some pyrophoric gases may have 
a delayed ignition time (UN GHS, 2013, Document ID 0086). OSHA 
preliminarily finds the term ``liable to ignite'' to be more accurate, 
from a technical perspective. OSHA does not believe that these changes 
would have a significant impact on the scope of

[[Page 9708]]

gases considered pyrophoric gases, nor does OSHA expect that chemical 
manufacturers or importers would need to reclassify chemicals due to 
these changes.
    As noted above, OSHA proposes adding a new sub-category for 
chemically unstable gases to the flammable gases hazard class to allow 
for more accurate communication of the hazards associated with those 
gases. OSHA proposes to adopt the GHS Rev. 7 definition of a chemically 
unstable gas, i.e., a flammable gas that is able to react explosively 
even in the absence of air or oxygen (UN GHS, 2017, Document ID 0060), 
in paragraph B.2.1. Consistent with the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060), under proposed Table B.2.1, a Category 1A chemically 
unstable gas would be further sub-characterized 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 
(680 [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 (680 [deg]F) and/or a pressure greater than 101.3 kPa 
(14.7 psi).
    As chemically unstable gas is a subcategory of flammable gases, any 
chemical that meets the criteria for chemically unstable gas meets the 
current definition of flammable gas. While these hazards are currently 
classified in flammable gases under the HCS the UNSCEGHS noted that 
these gases exhibit slightly different behaviors and 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 (UN GHS, 2010, Document ID 0210). Types of 
flammable gases or gas mixtures that might be candidates for 
classification as chemically unstable are flammable gases with 
functional groups such as triple-bonds, adjacent or conjugated double-
bonds, halogenated double-bonds, and strained rings (UN GHS, 2010, 
Document ID 0210). Because chemical manufacturers are currently 
classifying chemically unstable gases as flammable gases, OSHA does not 
consider these gases to be a new hazard. Instead, OSHA believes the 
addition of chemically unstable gases as a separate category in the 
appendix for flammable gases (appendix B.2) would improve the way the 
hazards of these gases are identified, evaluated, and communicated.
    The GHS Rev. 7 (UN GHS, 2017, Document ID 0060) added three 
clarifying notes under Table 2.2.1 that were not included in the GHS 
Rev. 3 (UN GHS, 2009, Document ID 0085). The notes provide guidance on 
the classification of flammable gases under the new hazard categories. 
OSHA is proposing to add these notes to the HCS following Table B.2.1 
(as new Note 2, Note 3, and Note 4) because they allow for better 
hazard classification.
    The GHS Rev. 7, in Chapter 2.2.4.2, provides additional guidance on 
the classification of flammable gases, including the new hazard 
categories of pyrophoric gases, chemically unstable gases, and 1B 
flammable gases (UN GHS, 2017, Document ID 0060). It includes updated 
references to consensus standards and test methods (i.e., ISO 
10156:2010), 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), or DIN 51794, and Part III of UN of the Manual of 
Tests and Criteria). OSHA proposes to adopt these changes in the HCS 
appendix B.2.3, 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 add statements that cited standards and test 
methods are incorporated by reference under 29 CFR 1910.6. This 
proposed modification would also align with the GHS Rev. 7 (UN GHS, 
2017, Document ID 0060). However, OSHA does not intend to require those 
already classified using an earlier version of ISO 10156, only those 
classifying new chemicals or chemicals not already classified. To 
incorporate this guidance from the GHS Chapter 2.2.4.2, OSHA is 
proposing edits to existing paragraph B.2.3. (B.2.3.1, as proposed) and 
new paragraphs B.2.3.2, B.2.3.3, and B.2.3.4.
Aerosols--(Appendix B.3)
    OSHA is proposing to follow the GHS Rev. 7 (UN GHS, 2017, Document 
ID 0060) by expanding the existing Flammable Aerosols hazard class 
(appendix B.3) to include non-flammable aerosols as well as flammable 
ones. Under the GHS Rev. 3 and the current HCS, Chapter 2.3 and 
appendix B.3, respectively, were titled ``Flammable Aerosols.'' Under 
the GHS Rev. 3, the hazards presented by non-flammable aerosols were 
either not classified at all or, more likely, were classified in 
another health hazard class or physical hazard class (e.g., gases under 
pressure) (UN GHS, 2009, Document ID 0085). Flammable aerosols were 
likely to be classified as both flammable aerosols and gases under 
pressure.
    OSHA believes that most aerosols are classified as gases under 
pressure under the GHS Rev. 3 (and accordingly under the existing HCS) 
because of the design criteria of the aerosols (ERG, 2015, Document ID 
0163) under DOT regulations. Under DOT regulations, aerosols are non-
refillable receptacles containing a gas compressed, liquefied, or 
dissolved under pressure, and the highest permissible pressure is 180 
psig at 130 [deg]F (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 psi) or more, or which are liquefied or liquefied and 
refrigerated (see existing paragraph B.5.1 in appendix B.5). However, 
OSHA believes that classifying aerosols as gases under pressure may not 
accurately identify the hazards of aerosols because aerosol containers 
differ from pressurized gas cylinders in terms of container 
characteristics and failure mechanisms, as described further below.
    Since the GHS Rev. 3 (UN GHS, 2009, Document ID 0085), the UNSCEGHS 
and the UN Sub-committee of Experts on the Transport of Dangerous Goods 
(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 (UN GHS, 2018, Document ID 0249). This hazard category 
captures aerosols that (1) contain 1% or less flammable components (by 
mass); and (2) have a heat of combustion that is less than 20 kJ/g.
    Before proposing to adopt this category for non-flammable aerosols, 
OSHA reviewed the impact of this change to ensure that it would not 
compromise worker safety and health. OSHA assessed the hazards 
associated with aerosol containers and compressed gas cylinders. An ERG 
study evaluated how aerosol products and gases under pressure differ in 
terms of container characteristics, failure mechanisms, and previous 
incidents (ERG, 2015, 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 (ERG, 2015, Document ID 0009). The report also noted 
differences in failure mechanisms for pressurized cylinders versus 
aerosols (ERG, 2015, Document ID 0009). As an example, increased 
temperatures can result in the release of container contents from the 
activation of pressure relief devices on

[[Page 9709]]

cylinders, whereas increased temperatures can result in the bursting of 
aerosol cans, which do not contain pressure relief devices. Also, 
hazards from falling cylinders include the release of contents 
following the valve breaking, the cylinder becoming a projectile or 
pinwheel, or the crushing of employees in the area; although aerosol 
containers can be damaged if they are dropped or punctured, they do not 
pose the same hazards as falling cylinders.
    ERG reported that occupational incidents involving cylinders 
included explosions during high temperature activities (such as 
welding) and explosions resulting from mechanical deformation (e.g., 
from falling cylinders), over-pressurization of cylinders (e.g., from 
overfilling, which can result in a rupture of the cylinder), or leaks 
due to corrosion (ERG, 2015, Document ID 0009). Most incidents with 
aerosol cans involved explosions following heating or puncture of the 
can (ERG, 2015, Document ID 0009). The ERG report concluded 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. (ERG, 2015, Document ID 0009).
    In addition to the ERG report, OSHA also considered data from the 
agency's Fatality and Catastrophe Information Summary (FatCat) 
database, located at https://www.osha.gov/pls/imis/accidentsearch.html 
(Document ID 0204), to evaluate the nature and severity of injuries and 
fatalities resulting from the use of aerosols and compressed gases. To 
determine if an incident was related to aerosols or compressed gas 
cylinders, OSHA searched for the keywords ``aerosol,'' ``spray,'' or 
``foam'' (to identify aerosols), and the keywords ``compressed,'' 
``cylinder,'' or ``CNG'' (to identify compressed gases). The data 
reviewed is available in the docket (OSHA, 2019, Document ID 0204).
    From 1995 to 2014 there were more incidents related to the use of 
compressed gas cylinders than to the use of aerosol containers, but the 
percentage of the incidents that resulted in fatalities was similar 
(29% versus 28%, respectively). However, as explained below, fatalities 
are more likely to be associated with the container itself when 
compressed gas receptacles are in use as compared to situations 
involving aerosol containers. (OSHA, 2019, Document 0204).
    Fatalities associated with use of compressed gas cylinders and 
aerosol containers primarily fall into three categories: (1) Incidents 
due to the contents of the container, such as flash fires or 
explosions; (2) incidents due to the container itself, such as 
incidents related to pressure, container failure, or ruptures; and (3) 
incidents unrelated to the use of the container, such as heart attacks 
or falls. A higher percentage of fatalities fell into the second 
category (incidents related to the container itself) for compressed gas 
cylinders (64% of the compressed gas cylinder fatalities) than for 
aerosol containers (17% of the aerosol fatalities). Conversely, a 
greater proportion of fatalities related to aerosols were attributed to 
reasons other than the container itself (83% for aerosol containers 
versus 36% for cylinders) (OSHA, 2019, Document ID 0204). This included 
fatalities related to the contents of the container and those in the 
third, ``miscellaneous,'' category (where the fatality could not be 
directly related to the use of the container, e.g., situations such as 
heart attacks, falls, lack of training that occurred while employees 
were working with, or that generally related to, the use of aerosol or 
compressed gas cylinders) (OSHA, 2019, Document 0204). Thus, it appears 
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.
    Following a review of the data and the ERG report, OSHA 
preliminarily concludes that a new category for non-flammable aerosols 
is appropriate. OSHA believes this category would allow the hazards of 
non-flammable aerosols to be more appropriately classified and 
communicated, resulting in improved worker protection. The new hazard 
category would provide downstream users with more appropriate 
communication on the label by adding precautionary statements: Keep 
away from heat, hot surfaces, sparks, open flames and other ignition 
sources; No smoking; and Do not pierce or burn, even after use (see 
appendix C). Additionally, 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).
    Specific changes OSHA is proposing include: Updating the aerosol 
hazard class to include non-flammable aerosols (hazard 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 the GHS Rev. 7 to paragraph B.3.2 (UN GHS, 
2017, Document ID 0060). For example, OSHA is proposing to revise Note 
2 to B.3.2.1 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's preliminarily conclusion that aerosols (flammable and 
non-flammable) should not also be classified as gases under pressure 
would ensure that the appropriate hazard warnings are presented on 
aerosol containers.
    OSHA is proposing to adopt the GHS Rev. 7 (UN GHS, 2017, 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, would update 
hazard communication requirements to better reflect the true hazards of 
non-flammable aerosols. This would result in changing the labeling for 
any such aerosols that are currently classified as compressed gases. In 
these situations, the ``gas cylinder'' pictogram would become 
unnecessary, as this hazard class would no longer be considered a 
compressed gas, the signal word ``danger'' would change to ``warning,'' 
due to the decreased hazard, and a hazard statement of ``contains gas 
under pressure; may explode if heated'' would change to ``pressurized 
container, may burst if heated'', which would more accurately reflect 
the hazards associated with this category (see proposed appendix 
C.4.16). As discussed above, OSHA believes that this approach would 
better differentiate between the hazards associated with compressed 
gases and the hazards associated with aerosols.
Oxidizing Gases--(Appendix B.4)
    OSHA proposes to revise the note in B.4.1, and the text in the 
``Additional classification considerations'' paragraph at B.4.3, to 
clarify that the provisions are referring to the most recent version of 
the ISO 10156 standard, (ISO, 10156, 2010). This proposed change would 
provide more clarity on the definition and classification of oxidizing 
gases and lead to more accurate classification and improved 
communication. This proposed modification would also align with the GHS 
Rev. 7 (UN GHS, 2017, Document ID 0060). However, OSHA does not intend 
to require those already classified using an earlier version of ISO 
10156, only those classifying new chemicals or chemicals not already 
classified.

[[Page 9710]]

Gases Under Pressure--(Appendix B.5)
    OSHA is proposing to change the definition of gases under pressure 
in B.5.1 to align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060). 
OSHA proposes to add a temperature of 20 degrees Celsius (68 degrees 
Fahrenheit) to the definition so that the full definition would define 
gases under pressure as gases which are contained in a receptacle at a 
pressure of 200 kPa (29 psi) (gauge) or more at 20 [deg]C (680 [deg]F), 
or which are liquefied or liquefied and refrigerated. The change is 
intended to clarify that the pressure of the receptacle is measured at 
standard conditions. OSHA is also proposing to add a note to Table 
B.5.1 to clarify that aerosols should not be classified as gases under 
pressure. This proposed change is a consequence of OSHA's proposal to 
add a new hazard category for non-flammable aerosols, as discussed 
previously.
Flammable Liquids--(Appendix B.6)
    OSHA is proposing to make three clarifying changes to the flammable 
liquid hazard class in appendix B.6. First, OSHA is proposing to add a 
reference to the Flammable Liquids standard, specifically 29 CFR 
1910.106(a)(14), in paragraph B.6.3 in order to provide additional 
guidance about methods that can be used to determine flashpoint.
    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.  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 is proposing 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. In addition, the proposed note would explain that the chemical 
manufacturer, importer, or distributor must clearly note on the SDS (in 
sections 7 and 9) if a calculation other than initial boiling point was 
used for storage purposes. OSHA did not intend for the updated HCS 
classification requirements for flammable liquids to impact the 
longstanding storage requirements under 29 CFR 1910.106 and views this 
proposed note as a method to ensure that the proper container size and 
type will be used for storing flammable liquids and that all necessary 
information is appropriately communicated on the SDS. OSHA is not 
proposing any changes to the classification criteria for flammable 
liquids under the HCS. OSHA is requesting comments on whether a 
footnote like the one proposed for B.6.3 should also be inserted in 
appendix D, section 9.
    Finally, OSHA realized that a note regarding cross-classification 
of aerosols was inadvertently omitted from appendix B.6 (flammable 
liquids). In appendix B.3 (flammable aerosols), note 2 to the 
classification criteria currently indicates that ``[f]lammable aerosols 
do not fall additionally within the scope of flammable gases, flammable 
liquids, or flammable solids.'' The HCS currently contains a cross-
referencing note in appendix B.2 (flammable gases), but OSHA 
inadvertently omitted the statement in appendix B.6 (flammable 
liquids). OSHA is therefore proposing to add a note stating that 
aerosols should not be classified as flammable liquids in appendix B.6, 
following Table B.6.1, for consistency and to minimize confusion. This 
would align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060).
Flammable Solids--(Appendix B.7)
    The only change proposed to appendix B. 7 (flammable solids) is a 
new note (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 
the GHS Rev. 7 includes this note (UN GHS, 2017, Document ID 0060).
Self-Heating Chemicals--(Appendix B.11)
    OSHA proposes adding a note to Table B.11.1. This proposed note 
would explain that classification of solid chemicals shall be based on 
tests performed on the chemical as presented. For example, if the 
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 the GHS Rev. 3 (UN GHS, 2009, 
Document ID 0085), 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 is proposing to add the note to be consistent with 
the GHS and the way the HCS treats other physical hazards.
Chemicals Which, in Contact With Water, Emit Flammable Gases--(Appendix 
B.12)
    OSHA proposes to update the classification criteria for Category 3 
of this hazard class in Table B.12.1. In the GHS Rev. 3 (UN GHS, 2009, 
Document ID 0085) and the existing 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.'' However, this criteria does not accurately reflect 
the corresponding criteria in Test N.5 (test method for substances 
which, in contact with water, emit flammable gases) in Part III, sub-
section 33.4.1.4.4.4 of the UN Manual of Tests and Criteria (UN TDG, 
2016, Document ID 0151), which provides that the maximum rate of 
evolution of the flammable gas is greater than 1 liter per kilogram of 
chemical per hour. OSHA proposes 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 method. This will 
align the HCS with the GHS Rev.7 (UN GHS, 2017, Document ID 0060) and 
would not affect worker protections.
Oxidizing Solids--(Appendix B.14)
    OSHA is proposing 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 the GHS 
Rev. 3 (UN GHS, 2009, Document, ID 0085), 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 (UN TDG, 2016, Document ID 0151). 
This is reflected in the current HCS, appendix B.14. However, 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

[[Page 9711]]

oxidizing solids, has been added to Part III, sub-section 34.4.3 of the 
UN Manual of Tests and Criteria (UN TDG MTC, 2016, Document ID 0151). 
This new test underwent a thorough evaluation, including round robin 
testing, led by the UNSCETDG (UN SCETDG, 2016, Document ID 0150). Test 
O.3 uses a reference mixture of calcium peroxide and cellulose, whereas 
Test O.1 uses the reference substances potassium bromate and cellulose 
(UN TDG, 2016, Document ID 0165).
    Consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060), 
OSHA proposes to allow oxidizing solids to be classified using either 
Test O.1 or Test O.3. 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 proposes 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 (IMSBC, 2017, Document ID 0141).
Corrosive to Metals--(Appendix B.16)
    OSHA is not proposing to make any changes to appendix B.16, 
Corrosive to Metals. This is notable because OSHA has preliminarily 
decided not to adopt a note that was added in the GHS Rev. 7. Table 
2.16.2 in Chapter 2.16 of the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060) contains a note stating: ``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.'' Chapter 1.4.10.5.5 contains labeling 
provisions that apply to ``substances or mixtures which are in the 
finished state as packaged for consumer use.'' OSHA has 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 (see 
29 CFR 1910.1200(b)(5)(v)). Therefore, OSHA is not proposing to adopt 
the note found in Table 2.16.2 of Chapter 2.16 of the GHS Rev. 7.
Desensitized Explosives--(Appendix B.17)
    OSHA is proposing to follow the GHS Rev. 7 (UN GHS, 2017, Document 
ID 0060) by adding a new physical hazard class for desensitized 
explosives. Desensitized explosives are chemicals that are treated in 
such a way to stabilize the chemical or reduce or suppress its 
explosive properties. 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 HCS, as revised in 2012, OSHA acknowledged, consistent with 
the GHS Rev. 3 (UN GHS, 2009, Document ID 0085), that these chemicals 
are considered explosives if the wetting agent is removed, by including 
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 (see 
existing appendix C at C.4.14). However, the hazard statement, signal 
word, pictogram and other precautionary statements required under 
existing C.4.14 are geared to 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 (UN GHS, 2005, Document ID 0206). The UNSCEGHS examined the 
issue of hazard classification for desensitized explosives and 
concluded a new hazard class was warranted to ensure the appropriate 
hazard statement, signal word and precautionary statements for 
desensitized explosives were incorporated into the GHS (UN GHS, Report, 
2014, Document ID 0087). The GHS Rev. 7 (UN GHS, 2017, Document ID 
0060; UN GHS, 2016, Document ID 0142) separately classified 
desensitized explosives with a full set of unique label elements 
(including the appropriate signal word, hazard statement, pictogram, 
and precautionary statements). As separately classified, 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 (e.g., Avoid heating 
under confinement or reduction of the desensitizing agent.).
    OSHA reviewed the UNSCEGHS reports (UN GHS, 2014, Document ID 0087) 
on desensitized explosives and has 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 are currently covered under the scope of the 
HCS as explosives, OSHA believes there is a benefit to providing 
classification criteria and corresponding hazard communication specific 
to this hazard. 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 proposes to add 
the desensitized explosives hazard class to the HCS as appendix B.17. 
Proposed appendix B.17 provides relevant definitions and general 
considerations, specifies applicable classification criteria, and 
includes information about additional classification considerations for 
this hazard class. It also references several sections from the UN 
Recommendations on the Transport of Dangerous Goods, Manual of Tests 
and Criteria that will be incorporated by reference. As with all hazard 
classes, the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) does not 
require testing and allows classifiers to use data reported in the 
literature (UN TDG, 2016, Document ID 0151) that was generated using 
specified (or equivalent) test methods. Proposed appendix C.4.30, 
discussed later in this document, contains proposed communication 
elements for desensitized explosives.
    Proposed appendix B.17 is based on Chapter 2.17 of the GHS Rev. 7 
(UN GHS, 2017, Document ID 0060). OSHA is proposing to adopt most of 
the classification language on desensitized explosives from Chapter 
2.17 of the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) to minimize 
deviations from the GHS. However, OSHA has carefully reviewed each of 
the hazard classification criteria within the context of the HCS and is 
proposing to modify some of the language. These edits include 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. Some of the GHS text stressing where a classification 
scheme is for scenarios other than transportation would also be removed 
(e.g., terms referring to storage, supply, and use); this change is 
being proposed because the HCS does not cover transportation, and it is 
therefore not necessary to include such language in appendix B of the 
HCS. OSHA also proposes adding a definition for ``phlegmatized'' in a

[[Page 9712]]

footnote because many stakeholders may be unfamiliar with that term 
from the UN Recommendations (UN GHS, 2017, Document ID 0060).
    OSHA is not proposing to include portions of the GHS Chapter 2.17 
that do not relate specifically to the method of classification for 
desensitized explosives; this is the same approach OSHA took in the 
2012 update. For example, similar to how OSHA has addressed the other 
hazard classes, OSHA is not proposing to adopt the decision logics from 
the GHS in appendix B.17; OSHA may, however, use them in guidance 
materials. Also, OSHA did not include text relating to hazard 
communication in proposed appendix B.17 because this information is 
contained in proposed appendix C.

E. Appendix C

    OSHA is proposing a number of updates to appendix C of the HCS in 
an effort to improve communication of hazard information on labels. 
These proposed changes will: (1) Address labeling requirements for the 
new hazard classes and categories in appendix B (physical hazards); (2) 
align the HCS with the GHS Rev. 7; and (3) improve alignment of the HCS 
and Health Canada's labeling requirements in furtherance of the goals 
of the RCC.
    Appendix C is the mandatory appendix that includes the requirements 
and instructions for the allocation of label elements. Paragraph (f)(2) 
of the HCS 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.
    As discussed in the 2009 NPRM proposing 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. OSHA is proposing a number of changes based on new 
precautionary statements and instructions in the GHS Rev. 7. 
Additionally, since 2012, OSHA has continued to work with other Federal 
agencies on crosscutting labeling issues. The updates proposed in 
appendix C would ensure alignment with DOT labeling regulations and are 
expected to provide the same level of protection for workers as the 
current HCS. OSHA is also proposing 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 that was signed in 
June 2018 (RCC, 2019, Document ID 0217), with the expectation of 
aligning efforts for international trade requirements between the two 
countries.
    Overall, OSHA expects that the proposed changes to appendix C would 
provide improved safety information and greater detail and clarity for 
downstream users. They also would provide better consistency that 
bridges the jurisdictional differences between countries and Federal 
agencies. Aligning the HCS with the GHS and other Federal or 
international regulations would ease compliance burdens for U.S. 
stakeholders that must also comply with those requirements. The changes 
that OSHA is proposing would lead to improved communication of hazard 
information, which would maintain or enhance the safety and health of 
workers.
    The changes OSHA is proposing to appendix Care extensive. OSHA 
addresses the substantive proposed changes in the discussion below, and 
a redline strike out version of appendix C, which reflects all of 
OSHA's proposed revisions, is available in the docket and on the OSHA 
website (OSHA HCS Redline Document, 2020, Document ID 0222; https://www.osha.gov/dsg/hazcom/). This will allow interested parties to view 
all of the proposed changes in context. OSHA strongly encourages 
stakeholders to review that document in conjunction with the discussion 
of the proposed revisions below, as the discussion below does not fully 
describe all of the non-substantive or editorial changes OSHA is 
proposing.
Proposed Changes to C.1-C.3
    The instructions currently found in the beginning of appendix C 
(see C.1-C.3) provide directions and information about the signal 
words, pictograms, hazard statements and precautionary statements 
required per C.4. OSHA is proposing changes to C.1-C.3 to align with 
the GHS Rev. 7, better harmonize the HCS with DOT regulations, and 
better harmonize the HCS with Health Canada.
    First, OSHA proposes 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 reflects OSHA's 
agreement with Health Canada to permit the exclamation mark pictogram 
to be used for HNOCs. While OSHA does not require labelling for HNOC 
hazards, Health Canada requires a pictogram, signal word, hazard 
statements, and precautionary statements for HNOCs. In order 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 (OSHA, 2016, Document 
ID 0103). Use of the exclamation mark pictogram would not be mandatory 
under the HCS.
    Relatedly, OSHA is proposing a number of additional changes. As 
discussed above, OSHA is proposing to move the current C.2.3.3 from 
appendix C to paragraph (f)(5) in the text of the standard, so that all 
of the instructions related to the transport of hazardous chemicals and 
DOT are in one section of the HCS. OSHA is also proposing to add a new 
paragraph C.2.3.3, 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. Health 
Canada and OSHA have agreed that the exclamation mark pictogram is an 
appropriate symbol for the HNOC, HHNOC (Health Hazards Not Otherwise 
Classified), and PHNOC (Physical Hazards Not Otherwise Classified) 
classifications. Additionally, because any pictogram may appear only 
once on a label, OSHA is also proposing 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 
when the exclamation mark pictogram would be used, including as 
supplemental information for another hazard, such as HNOC. OSHA is 
requesting comments on these proposed changes, and is particularly 
interested in comments on whether the agency should require the 
exclamation mark pictogram to be used for HNOCs.
    The remaining changes 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

[[Page 9713]]

information. OSHA is proposing 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 would also 
provide 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 is also proposing 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.
    OSHA is also proposing to add a new paragraph, C.2.4.10, to further 
address cases where substances or mixtures may trigger multiple 
precautionary statements for medical responses. Consistent with the GHS 
Rev. 7 (UN GHS, 2017, Documents ID 0060), OSHA is proposing principles 
for addressing situations where a substance or mixture is classified 
for a number of hazards and triggers multiple precautionary statements 
for medical responses (e.g., calling a poison center/doctor/. . . . and 
getting medical advice/attention). Proposed paragraph C.2.4.10 would 
provide for a system of prioritization for precautionary statements. 
Under proposed C.2.4.10(a), labels would usually need only include one 
precautionary statement reflecting the response at the highest level 
with the greatest urgency, combined with at least one route of exposure 
or symptom ``IF'' statement. For example, the statement, ``Immediately 
call a poison center/doctor/. . .'' would be prioritized over the less 
urgent ``call a poison center/doctor.''
    OSHA 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. However, OSHA also 
understands the difficulty involved in providing a long list of medical 
responses and that this could lead to confusion, particularly when 
immediate action is required. Therefore, proposed paragraph C.2.4.10(b) 
would allow for (but not require) combination of medical response 
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. 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. In those cases, both 
statements should appear without prioritization. OSHA is requesting 
comments on whether precautionary statements for medical responses 
should be prioritized and seeks input on the best method(s) to use for 
prioritization.
Proposed Revisions to C.4
    OSHA is proposing to update the hazard label elements for specific 
hazard classes and categories. The following discussion on proposed 
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 proposing to adopt. In the discussion of precautionary 
statements, OSHA will explain the proposed changes to the statements 
and indicate what hazard classes/categories trigger these statements. 
As noted previously, a redline strike out version of appendix C is 
available in the docket and on OSHA's website so interested parties can 
see all of the proposed changes in context (OSHA HCS Redline, 2020, 
Document ID 0222; https://www.osha.gov/dsg/hazcom/).
Proposed Revisions Based on Additions of Hazard Classes and Categories
    OSHA is proposing a number of consequential 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 is proposing a number of changes to the flammable gas hazard 
class. The changes would include: (1) Subdividing category 1 flammable 
gases into categories 1A and 1B; (2) adding pyrophoric gases into 
category 1A; and (3) adding chemically unstable gases into category 1A 
(further subdivided into chemically unstable gas A and chemically 
unstable gas B). The proposed hazard and precautionary statements for 
those gases, consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060) are in C.4.15. 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, the hazard statement for the new category 1B 
flammable gases would be ``Flammable gas.'' 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 also discussed in the Summary and Explanation for appendix B, 
OSHA is proposing to add non-flammable aerosols to the existing 
``Flammable Aerosols'' hazard class and to rename the class 
``Aerosols.'' Consequently, in appendix C, OSHA proposes to adopt the 
GHS Rev. 7 (UN GHS, 2017, Document ID 0060) hazard and precautionary 
statements for non-flammable aerosols in C.4.16. OSHA believes that 
these communication requirements would better address the true hazards 
of aerosols. In cases where aerosols are currently labeled as gases 
under pressure, the proposal would require the label to be updated to 
include the flame pictogram for hazard 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); the 
hazard statement ``pressurized container, may burst if heated'' would 
also be required. These changes would better differentiate the hazards 
of non-flammable aerosols from those of gases under pressure.
    Finally, OSHA is also proposing to adopt the hazard class of 
desensitized explosives in appendix B, and consequently to adopt, in 
appendix C, the pictogram, signal word, hazard statements, and 
precautionary statements for desensitized explosives from the GHS Rev. 
7 (UN GHS, 2017, Document ID 0060). Under the proposal, the labeling 
information for desensitized explosives would be at C.4.30.
    For flammable gases, aerosols, and desensitized explosives, OSHA is 
proposing to adopt the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) 
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). 
OSHA believes that the information called for by the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060) effectively communicates the hazards of 
those substances and the precautions that need to be taken when 
handling them.

[[Page 9714]]

Therefore, requiring the information to appear on labels would improve 
hazard communication and enhance worker safety. In addition, because 
the changes would align the HCS with the GHS, adopting them would ease 
compliance burdens for U.S. stakeholders that must also comply with 
international requirements for hazard communication.
Proposed Revisions to Hazard and Precautionary Statements, Hazard 
Categories, and Notes
    OSHA is proposing to revise a number of hazard and precautionary 
statements to align with the GHS Rev. 7. The hazard and precautionary 
statements in the current HCS were adopted from the GHS Rev. 3. Since 
the HCS was last updated in 2012, the UNSCEGHS has continued to discuss 
the utility and readability of the label elements, including hazard and 
precautionary statements, in order to improve the information 
presented. The specific goals of the UNSCEGHS are to make labeling 
information more comprehensible and useable by explaining and 
clarifying ambiguous or unhelpful instructions or statements and 
eliminating inconsistencies in statements (UN GHS, 2018, Document ID 
0095; UN GHS, 2018, Document ID 0213). In addition, the UNSCEGHS is 
considering how precautionary statements could be consolidated or 
combined to save label space and make labels more readable and clear, 
all of which improve the safety message (UN GHS, 2018, Document ID 
0095; UN GHS, 2018, Document ID 0213). OSHA shares these goals with the 
UNSCEGHS because they lead to better communication of hazards and 
therefore maintain or enhance protection of worker safety and health. 
Unless otherwise discussed below, OSHA is proposing to adopt the 
updated communication information presented in the GHS Rev. 7 (UN GHS, 
2017, 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).
Proposed Revisions to Tables C.4.1, C.4.2, and C.4.3 (Acute Toxicity 
Tables)
    OSHA is proposing to consolidate hazard category information for 
acute toxicity--oral, C.4.1. The change would involve deleting the 
table for acute toxicity--oral, category 3 and combining categories 1, 
2, and 3 in one table, since all three categories have the same 
precautionary statements. None of the substantive communication 
information for categories 1, 2, or 3 would change, and the intent of 
the proposed modification is simply to make C.4.1 more concise.
Proposed Revisions to Precautionary Statements
    The original GHS (UN GHS Rev. 1, 2005, Document ID 0215) 
precautionary statements were developed from existing classification 
systems, including the IPCS International Chemical Safety Card (ICSC) 
Compilers Guide (IPCS International, 2012, Document ID 0158), the 
American National Standards (ANSI Z129.1 2010, Document ID 0102), the 
EU classification and labelling directives, the Emergency Response 
Guidebook (UN TDG, 2016, Document ID 0218), and the Pesticide Label 
Review Manual of the United States Environmental Protection Agency 
(EPA, 2018, Document ID 0056). Since publication of the updates to the 
HCS in 2012, the UNSCEGHS has 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 proposed revisions to precautionary statements 
in appendix C.4. The intent or reasons provided below for the proposed 
changes reflect OSHA's preliminary 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).
Proposed Changes in Prevention Column
    Wear protective equipment (e.g., gloves/protective clothing).
    A precautionary statement for acute toxicity--dermal (categories 1-
4) (Table C.4.2), skin corrosion/irritation (categories 1A-1C) (Table 
C.4.4), eye damage/irritation (categories 1 and 2A) (Table C.4.5), and 
sensitization--skin (Table C.4.7) specifies personal protective 
equipment, such as ``wear protective gloves'' or ``wear eye protection/
face protection.'' Instructions for the statement currently indicate 
that the chemical manufacturer, importer, or distributer is ``to 
specify type of equipment.'' OSHA proposes to revise the instruction to 
state that the chemical manufacturer, importer, or distributor may 
further specify type of equipment where appropriate. The intent of this 
proposed revision is to clarify that label preparers may provide 
additional specification about the type of protective equipment, where 
appropriate, and to align with the GHS Rev. 7 (UN GHS, 2017, Document 
ID 0060).
    Because specific hazards may require specific protective equipment 
or instructions, current precautionary statements and instructions for 
certain health hazards (e.g., germ cell mutagenicity, see Table C.4.8; 
carcinogenicity, see Table C.4.9; and reproductive toxicity, see Table 
C.4.10) and the majority of physical hazard classes specify one or more 
types of personal protective equipment and indicate that the chemical 
manufacturer, importer, or distributor is to specify the type of 
equipment. The types of equipment currently listed in the HCS were 
adopted from the GHS Rev. 3 and vary for the different hazard classes. 
In 2010, the UNSCEGHS recommended that the precautionary statement 
``Wear protective gloves/protective clothing/eye protection/face 
protection'' be used for the hazard classes of germ cell mutagenicity 
(C.4.8), carcinogenicity (C.4.9), reproductive toxicity (C.4.10), 
explosives (C.4.14) and unstable explosives (C.4.30) (UN GHS, 2010, 
Document ID 0149), and this statement was included in the HCS in 2012. 
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 (UN GHS, 2015, Document ID 0219). 
Accordingly, the UNSCEGHS revised the precautionary statement to read, 
``Wear protective gloves/protective clothing/eye protection/face 
protection/hearing protection. . .'' (UN GHS, 2016, Document ID 0147). 
Adding the term ``/hearing protection. . .'' provides flexibility 
because hearing protection and other equipment can be selected when 
appropriate and not selected if not relevant. Adding the ellipsis at 
the end of the statement allows other types of personal protective 
equipment to be listed as necessary. The UNSCEGHS also revised the 
instruction for the precautionary statement to make it clear that it is 
referring to personal protective equipment. Consistent with the GHS 
Rev. 7 (UN GHS, 2017, Document ID 0060) OSHA is proposing to adopt this 
revised precautionary statement and instruction for all relevant 
hazards: germ cell mutagenicity (C.4.8), categories 1A, 1B, and 2; 
carcinogenicity (C.4.9), categories 1A, 1B, and 2; reproductive 
toxicity (C.4.10), categories 1A, 1B, and 2; explosives (C.4.14),

[[Page 9715]]

unstable and division 1.1-1.5; flammable gases (C.4.15), category 1A, 
pyrophoric; flammable liquids (C.4.19), categories 1, 2, 3, and 4; 
flammable solids (C.4.20), categories 1 and 2; self-reactive substances 
and mixtures (C.4.21), categories Types A, B, C, D, E, and F; 
pyrophoric liquids (C.4.22), category 1; pyrophoric solids (C.4.23), 
category 1; self-heating substances and mixtures (C.4.24), categories 
1, and 2; substances and mixtures which, in contact with water, emit 
flammable gases (C.4.25), categories 1, 2, and 3; oxidizing liquids 
(C.4.26), categories 1, 2, and 3; oxidizing solids (C.4.27), categories 
1, 2, and 3; organic peroxides (C.4.28), categories Types A, B, C, D, 
E, and F; and desensitized explosives (proposed new C.4.30), categories 
1, 2, 3, and 4.
Avoid Contact During Pregnancy/While Nursing
    In Table C.4.10, for reproductive toxicity (effects on or via 
lactation), OSHA is proposing to revise a precautionary statement that 
currently says to avoid contact ``during pregnancy/while nursing'' so 
it reads ``during pregnancy and while nursing.'' This proposed revision 
would clarify that the chemical manufacturer, importer or distributor 
is not to choose between ``during pregnancy'' and ``while nursing'' but 
is to include both scenarios on the label. This proposed change would 
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2012, Document ID 0155).
Do Not Handle Until all Safety Precautions Have Been Read and 
Understood
    For unstable explosives (Table C.4.14), OSHA is proposing to delete 
the precautionary statement about not handling until all safety 
precautions have been read and understood. A statement to obtain 
special instructions before use is already included and that statement 
is shorter and more relevant to safety. This proposed change would 
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2012, Document ID 0155).
Do Not Subject to Grinding/Shock/Friction
    OSHA also proposes adding the precautionary statement ``Do not 
subject to grinding/shock/friction/. . .'' to the table for unstable 
explosives (Table C.4.14). That statement is already included for the 
other explosives categories, and is also relevant for unstable 
explosives. For each of the explosives categories that contain that 
statement, an explanatory conditional note clarifying that the 
statement applies only if the explosive is mechanically sensitive would 
also be added. These proposed changes would align with the GHS Rev. 7 
(UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS 
2012, Document ID 0153).
Keep Away From Heat/Sparks/Open Flames/Hot Surfaces
    A number of the hazard classes that include flammable chemicals 
currently require precautionary statements and instructions about 
keeping away from ignition sources (heat/sparks/open flames/hot 
surfaces). Those statements generally require the chemical 
manufacturer, importer, or distributor to select one or more of the 
ignition sources listed, as applicable. OSHA is proposing to include 
more ignition sources in the statement and to require that they all be 
listed on the label. With that change, the statement would read, ``Keep 
away from heat, hot surfaces, sparks, open flames, and other ignition 
sources.'' OSHA believes this change, which is consistent with the GHS 
Rev.7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152), 
would improve hazard communication by making users aware of additional 
ignition sources that should be avoided. The change would be made to 
precautionary statements for explosives (divisions 1.1-1.5 in Table 
C.4.14), flammable gases (Table C.4.15), aerosols (Table C.4.16), 
flammable liquids (Table C.4.19), flammable solids (Table C.4.20), 
self-reactive substances and mixtures (Table C.4.21), pyrophoric 
liquids (Table C.4.22), pyrophoric solids (Table C.4.23), oxidizing 
liquids (Table C.4.26), oxidizing solids (Table C.4.27), organic 
peroxides (Table C.4.28), and desensitized explosives (Table C.4.30).
Keep Wetted With
    A conditional instruction used for division 1.1-1.3 and 1.5 
explosives in Table C.4.14 currently states that the chemical 
manufacturer, importer, or distributer is to include the precautionary 
statement ``Keep wetted with. . .'' under conditions where drying would 
increase the explosion hazard, except as needed for manufacturing or 
operating processes. The GHS Rev. 7 changes 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'' (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 
0152; UN GHS, 2012, Document ID 0153). OSHA is proposing to make the 
same change in order to clarify when the ``Keep wetted with. . .'' 
statement is appropriate.
    The ``Keep wetted with. . .'' precautionary statement also appears 
in proposed C.4.30, desensitized explosives. Consistent with the GHS 
Rev. 7 (UN GHS, 2017, Document ID 0060), OSHA is not proposing 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. OSHA requests 
comment on these proposed changes.
Keep Only in Original Container
    OSHA proposes to revise the statement ``Keep only in original 
container'' to ``Keep only in original packaging'' for self-reactive 
substances and mixtures (Table C.4.21), organic peroxides (Table 
C.4.28), and corrosive to metals (Table C.4.29). The revised statement 
would also be added to explosives in division 1.1-1.5 (Table C.4.14). 
OSHA believes that this proposed change is appropriate because the term 
``packaging'' is more inclusive than ``container'' and would include 
the transport packaging as well as the immediate container. These 
proposed changes are consistent with the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060; UN GHS, 2012, Document ID 0152).
Ground/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 proposes changing ``Ground/bond'' 
to ``Ground and bond'' to clarify that both of those precautions are to 
be included on the label. Appendix 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. These proposed changes would 
apply to explosives (division 1.1-1.5 in Table C.4.14), flammable 
liquids (categories 1-3 in Table C.4.19), and flammable solids (Table 
C.4.20). In addition, OSHA is proposing to revise existing 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 (Table C.4.19) and to

[[Page 9716]]

explosives and flammable solids only if they are electrostatically 
sensitive (Tables C.4.14 and C.4.20). OSHA is also proposing 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 (Table 
C.4.21) and organic peroxides (Table C.4.28) because the precaution is 
also appropriate for those hazard classes. These proposed changes would 
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2012, Document ID 0152).
Keep/Store Away From Clothing, and Other Combustible Materials
    OSHA is proposing to standardize precautionary statements regarding 
combustible materials for oxidizing chemicals. Currently, the tables 
for oxidizing gases (Table C.4.17), oxidizing liquids (Table C.4.26, 
hazard categories 2 and 3), and oxidizing solids (Table C.4.27, hazard 
categories 2 and 3) require the precautionary statement ``Keep/Store 
away from clothing/. . . /combustible materials,'' along with 
instructions for the chemical manufacturer, importer, or distributor to 
specify incompatible materials. OSHA proposes to change the statement 
to read: ``Keep away from clothing and other combustible materials,'' 
and to delete the instruction regarding incompatible materials, to make 
the statement more consistent with the statement currently applicable 
to hazard category 1 in both oxidizing liquids (Table C.4.26) and 
oxidizing solids (Table C.4.27). OSHA believes the proposed change is 
appropriate because the general term ``combustible materials'' 
encompasses any other materials that are incompatible with oxidizers. 
In addition, OSHA believes 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. 
Finally, OSHA is also proposing to remove the redundant statement 
``Take any precaution to avoid mixing with combustibles/. . .'' under 
oxidizing liquids (Table C.4.26) and oxidizing solids (Table C.4.27), 
since this information is duplicative of the ``keep away from'' 
statement. These proposed changes are consistent with the GHS Rev. 7 
(UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152).
    OSHA is proposing to remove the ``keep/store away from clothing/. . 
. /combustible materials'' precautionary statement, along with its 
instruction, for self-reactive substances and mixtures (Table C.4.21) 
and organic peroxides (Table C.4.28). 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. These proposed changes would also align 
with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, 
Document ID 0152; UN GHS, 2012, Document ID 0153).
Keep Valves and Fittings Free From Oil and Grease
    For oxidizing gases (Table C.4.17), a precautionary statement 
currently allows the chemical manufacturer, importer, or distributor to 
specify that either ``reduction valves'' or ``valves and fittings'' be 
kept free from oil and grease. OSHA is proposing to revise the 
statement to ``Keep valves and fittings free from oil and grease.'' 
OSHA believes the change is appropriate because all valves and fittings 
must be kept free of oil and grease, not just the reduction valves 
attached to pressure receptacles. This proposed change is consistent 
with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2010, 
Document ID 0149).
Wear Cold Insulating Gloves/Face Shield/Eye Protection
    OSHA is proposing to revise the precautionary statement for 
refrigerated liquefied gases (Table C.4.18), which currently provides 
that either cold insulated gloves, a face shield, or eye protection is 
to be used. The proposed change would 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. This 
proposed change would align with the GHS Rev. 7 (UN GHS, 2017, Document 
ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 
0153).
Keep Container Tightly Closed
    The precautionary statement ``Keep container tightly closed'' is 
used for flammable liquids (categories 1-3 in Table C.4.19). The GHS 
Rev. 7 contains a conditional instruction indicating that the statement 
is to be used if the liquid is volatile and may generate an explosive 
atmosphere (UN GHS, 2017, Document ID 0060). OSHA is proposing to add 
this conditional instruction to the precautionary statement for 
flammable liquids (categories 1-3) because it clarifies the types of 
flammable liquids for which the statement applies.
    OSHA also proposes to add the precautionary statement ``Keep 
container tightly closed'' to pyrophoric liquids (Table C.4.22) and 
pyrophoric solids (Table C.4.23). OSHA believes 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 
does not believe a conditional note is necessary. These proposed 
changes would also align with the GHS, Rev. 7 (UN GHS, 2017, Document 
ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 
0153).
Take Precautionary Measures Against Static Discharge
    For flammable liquids (Table C.4.19, hazard categories 1-3), OSHA 
proposes to revise the precautionary statement ``Take precautionary 
measures against static discharge'' to ``Take action to prevent static 
discharge.'' The revision would simply shorten the statement and 
clarify what action needs to be taken. OSHA also proposes to add a note 
that this precautionary statement is to be used if the liquid is 
volatile and may generate an explosive atmosphere. These proposed 
changes are consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Flammable Liquids/Solids Conditional Instructions
    OSHA is proposing additional conditional instructions for flammable 
liquids (Table C.4.19) and flammable solids (Table C.4.20). Some 
categories of flammable liquids (categories 1-3) and flammable solids 
(categories 1 and 2) contain a precautionary statement specifying the 
use of ``explosion-proof [electrical/ventilating/lighting/. . .] 
equipment.'' OSHA believes that SDS and label creators are not actually 
properly and specifically identifying the prevention measures for the 
particular chemical, but rather are listing the entire line without the 
required details. For liquids, OSHA proposes a new conditional 
instruction to clarify that the statement is required if the chemical 
is volatile and may generate an explosive atmosphere. For both liquids 
and solids, a conditional instruction would be added to indicate that 
text in

[[Page 9717]]

square brackets may be used to specify specific electrical, 
ventilating, lighting or other equipment if necessary and as 
appropriate. These proposed changes would align with the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 
2012, Document ID 0153).
    OSHA is also proposing to add a conditional instruction to the 
precautionary statement to use non-sparking tools for flammable liquids 
(categories 1-3, Table C.4.19). The statement would clarify that the 
precautionary statement is only needed if the liquid is volatile and 
may generate an explosive atmosphere, and if the minimum ignition 
energy is very low (<0.1 mJ). The precautionary statement has very 
limited applicability for flammable liquids and therefore OSHA believes 
that the conditions need to be specified. This proposed change is also 
consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Keep Cool
    For self-reactive substances and mixtures and organic peroxides 
(Tables C.4.21 and C.4.28), OSHA is proposing to move the precautionary 
statement ``Keep cool'' from the storage column to the prevention 
column. The precautionary statement is not needed in the storage column 
because that column includes a precautionary statement about storage 
temperatures not to be exceeded, and as discussed below, OSHA is 
proposing to add conditional instructions to that column to inform 
users of when a storage temperature would need to be listed. Under the 
prevention column, OSHA is proposing to include a conditional 
instruction indicating that the precautionary statement may be omitted 
if storage temperatures are included on the label. This proposed 
revision would not materially change the information that is presented 
on the label, and is consistent with the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, 
Document ID 0153).
    For self-heating substances and mixtures (Table C.4.24), a combined 
precautionary statement currently instructs the user to keep cool and 
protect from sunlight. OSHA is proposing 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 is proposing 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 believes that these 
proposed changes would provide the label preparer better instructions 
and would provide the appropriate level of information on the label 
without repetition. These proposed changes would also align with the 
GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 
0152; UN GHS, 2012, Document ID 0153).
Do Not Allow Contact With
    OSHA is proposing 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 pyrophoric 
gases (proposed C.4.15, category 1A), pyrophoric liquids (C.4.22), and 
pyrophoric solids (C.4.23)) or water (for substances and mixtures that 
emit flammable gases in contact with water (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, 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. These proposed changes would align with the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 
2012, Document ID 0153).
Handle Contents Under Inert Gas
    For substances and mixtures which, in contact with water, emit 
flammable gases (Table C.4.25), OSHA proposes changing the 
precautionary statement ``Handle under inert gas. Protect from 
moisture'' to ``Handle and store contents under inert gas/. . . Protect 
from moisture.'' This would clarify that these substances should always 
be under inert atmospheres. In addition, conditional instructions would 
be added to indicate that if the substance or mixture reacts readily 
with moisture in air, then the chemical manufacturer, importer or 
distributer also has to specify the appropriate liquid or gas if inert 
gas is not appropriate. 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) (UN GHS, 
2010, Document ID 0149). This proposed change is consistent with the 
GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 
0152; UN GHS, 2012, Document ID 0153).
    OSHA is also proposing to add the statement ``Handle and store 
contents under inert gas/. . .'' to pyrophoric liquids (C.4.22) and 
pyrophoric solids (C.4.23). 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. Pyrophoric chemicals, by 
definition, are likely to ignite when in contact with air. Both Tables 
C.4.22 and C.4.23 currently contain 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 is proposing to include in the prevention 
column, OSHA would delete this language from the storage column. OSHA 
believes that the language being proposed for the prevention column 
would emphasize that pyrophoric chemicals must be handled, as well as 
stored, under inert atmospheres. OSHA notes that the statements OSHA is 
proposing to add to the prevention column for Tables C.4.22 (pyrophoric 
liquids) and C.4.23 (pyrophoric solids) regarding handling and storing 
contents under inert gas were included in the GHS Rev. 5, but were 
inadvertently omitted from Rev. 7 (UN GHS, 2016, Document ID 0211; UN 
GHS, 2017, Document ID 0060). If OSHA finalizes the language as 
proposed, it will work with the UNSCEGHS to have this statement 
reinstated in future GHS revisions.
Wear Fire/Flame Resistant/Retardant Clothing
    Category 1 oxidizing liquids (C.4.26) and category 1 oxidizing 
solids (C.4.27) currently have the precautionary statement ``Wear fire/
flame resistant/retardant clothing.'' The intent of that statement is 
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 proposes to replace the existing 
statement with ``Wear fire resistant or flame retardant clothing.'' 
This would clarify the intent of this statement and is consistent with 
the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document 
ID 0152; UN GHS, 2012, Document ID 0153).

[[Page 9718]]

Proposed Changes in Response Column
    For the response column, a number of the proposed revisions in 
appendix C are simply editorial and are made to improve clarity, 
correct simple omissions of a word or phrase, or more efficiently and 
concisely combine different precautionary statements. For example, OSHA 
is proposing 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 the GHS Rev. 7 (UN GHS, 2017, Document ID 0060), 
and the additional phrase would add clarity. Another example is OSHA's 
proposal to add the phrase ``In case of fire'' at the beginning of the 
precautionary statements related to fire fighting for unstable 
explosives, as is already done for other explosives categories (see 
C.4.14). In a number of cases, OSHA is proposing 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 would now 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 proposed changes that are 
simply editorial in nature (although all proposed revisions can be 
found in the redlined version of appendix C that is available as part 
of the rulemaking record (OSHA HCS Redline, 2020, Document ID 0222) and 
on OSHA's website (https://www.osha.gov/dsg/hazcom). The discussion 
below highlights the substantive changes OSHA is proposing to make to 
the response column in appendix C.
Take Off Immediately All Contaminated Clothing. Rinse Skin With Water/
Shower
    The existing precautionary statements for skin corrosion/irritation 
(categories 1A to 1C in C.4.4) and flammable liquids (categories 1-3 in 
C.4.19) indicate 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 proposes 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. The 
reason for the proposed change is 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. The proposed change 
would align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN 
GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Get Medical Advice/Attention
    A number of health hazards (i.e., skin corrosion/irritation 
(category 2 in Table C.4.4), eye damage/irritation (categories 2A and 
2B in Table C.4.5), sensitization--skin (Table C.4.7), germ cell 
mutagenicity (Table C.4.8), carcinogenicity (Table C.4.9), reproductive 
toxicity (Table C.4.10), specific target organ toxicity--repeated 
exposure (Table C.4.12), and refrigerated liquefied gases (Table 
C.4.18)) have combined precautionary statements that include the 
statement ``get medical advice/attention.'' OSHA is proposing to add an 
instruction indicating that the chemical manufacturer, importer, or 
distributer is to select medical advice or attention as appropriate. 
This is 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 the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060).
If Breathing Is Difficult, Remove Person to Fresh Air and Keep 
Comfortable for Breathing
    A precautionary statement used for sensitization--respiratory 
(Table C.4.6) currently states ``If inhaled: If breathing is difficult, 
remove person to fresh air and keep comfortable for breathing.'' OSHA 
is proposing to remove the phrase ``if breathing is difficult.'' This 
is because including two conditions, ``if inhaled'' and ``if breathing 
is difficult,'' is confusing and unnecessary. Removal of the phrase 
would also make the precautionary statement consistent with the 
statement as it appears in other hazard classes in appendix C.4, such 
as acute toxicity--inhalation (Table C.4.3). This proposed change is 
consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2010, Document ID 0149).
Take Off Contaminated Clothing and Wash it Before Reuse
    A precautionary statement for skin sensitization (Table C.4.7) 
currently says to wash contaminated clothing before reuse. OSHA is 
proposing to add the phrase ``Take off contaminated clothing and'' to 
this precautionary statement. The UNSCEGHS previously recommended that 
this additional phrase be used for acute toxicity--dermal; skin 
irritation, category 2; and sensitization--skin (UN GHS, 2010, Document 
ID 0154). The phrase was inadvertently omitted for skin sensitization 
in the GHS Rev. 3 (UN GHS, 2009, Document ID 0085), and accordingly in 
the updates to the HCS in 2012, but it has since been added to the GHS 
Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2010, Document ID 0149; 
UN GHS, 2010, Document ID 0154).
If Exposed or Concerned
    For specific target organ toxicity (single exposure) (Table 
C.4.11), OSHA is proposing to revise a precautionary statement 
indicating ``If exposed'' to ``If exposed or concerned.'' The revision, 
which would be consistent with language currently used for the germ 
cell mutagenicity (Table C.4.8), carcinogenicity (Table C.4.9), and 
reproductive toxicity (Table C.4.10) hazard classes, would maintain 
consistency throughout C.4 and with the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060). In 2010, a GHS subcommittee recommended that 
wherever ``If exposed'' is used, it be revised to ``If exposed or 
concerned,'' since the user of the chemical may not have evidence of 
exposure (UN GHS, 2010, Document ID 0154).
Division 1.4 Explosives (C.4.14) Precautionary Statements
    For Division 1.4 explosives, the HCS currently provides fire-
fighting precautionary statements and instructions on when to apply 
them (Table C.4.14). OSHA is proposing two changes to these statements. 
First, OSHA is proposing to change the instruction note from ``for 
explosives are 1.4S ammunition and components thereof'' to ``for 
explosives of division 1.4 (compatibility group S) in transport 
packaging.'' This revision would provide clarity about when the note 
applies and there is no intended change in meaning. Second, OSHA is 
proposing to revise the precautionary statement ``Fight fire with 
normal precautions from a reasonable distance'' to the statement 
``Fight fire remotely due to the risk of explosion.'' OSHA believes the 
proposed new statement is more appropriate and protective because it 
specifies the explosion risk due to fire associated with 1.4 
compatibility group S (1.4S) explosives. These proposed changes would 
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2012, Document ID 0152; UN GHS, 2012, Document ID 0153).

[[Page 9719]]

Eliminate All Ignition Sources, if Safe To Do So
    For category 1 and 2 flammable gases (C.4.15), a precautionary 
statement currently instructs the user to eliminate all ignition 
sources if safe to do so. OSHA proposes to revise the statement to ``In 
case of leakage, eliminate all ignition sources.'' The term ``in case 
of leakage'' would be added to stress that it is important to eliminate 
flammable gas leaks, even where the leaking gas is not burning, because 
the leak could create an explosive atmosphere. The term ``if safe to do 
so'' would be deleted because it could discourage quick action. 
Eliminating gas leaks would not be expected where a fire would hinder 
that action. OSHA is also proposing to add this statement to pyrophoric 
gases 1A and chemically unstable gases A and B. These proposed changes 
would be consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060; UNGHS, 2012, Document ID 0152).
In Case of Fire Use . . . To Extinguish
    For self-reactive substances and mixtures (type A) (C.4.21), OSHA 
is proposing 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 language 
OSHA is proposing to delete, OSHA proposes to use language stating ``In 
case of fire: Explosion risk. Do NOT fight fire when fire reaches 
explosives.'' These changes would align with the GHS Rev. 7 (UN GHS, 
2017, Document ID 0060) and are proposed because it is dangerous to 
fight a fire involving this type of material and individuals should 
always be advised against it (UN GHS, 2012, Document ID 0152; UN GHS, 
2012, Document ID 0153). OSHA is not proposing to change the existing 
statement about evacuating the area.
    For type B self-reactive substances and mixtures (C.4.21), OSHA is 
proposing to combine existing precautionary statements and to delete 
duplicate phrases that would occur with the new combination. OSHA does 
not intend these changes to alter the meaning of the statements. OSHA 
is proposing 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. This is to 
preserve the conditions of use with the new combination of phrases. 
These proposed changes would align with the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060; UN GHS, 2012, Document ID 0095).
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 the 
GHS Rev. 3 (UN GHS, 2009, Document ID 0085), or in the current HCS, for 
organic peroxides (C.4.28). The UNSCEGHS has since adopted these 
precautionary statements (UN GHS, 2012, Document ID 0095). As in GHS 
Rev. 7 (UN GHS, 2017, Document ID 0060), OSHA is proposing to adopt the 
same precautionary statements in the response column for organic 
peroxides (C.4.28) as for self-reactive substances and mixtures 
(C.4.21). OSHA believes 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 (UN GHS, 2012, Document ID 0152; UN GHS, 
Document ID 0153; UN GHS, 2012, Document ID 0095).
Immerse in Cool Water/Wrap With Wet Bandages
    For pyrophoric liquids (C.4.22), pyrophoric solids (C.4.23), and 
substances and mixtures which in contact with water emit flammable 
gases (C.4.25), a precautionary statement currently indicates 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 is proposing to change the forward slash to an ``or'' so 
that the statement would read ``Immerse in cool water or wrap in wet 
bandages.'' The change is proposed to make clear that the chemical 
manufacturer, importer, or distributer is not to choose one action or 
the other but is to include both actions on the label. In the case of 
substances and mixtures which, in contact with water, emit flammable 
gases, OSHA is proposing 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.'' This change is 
proposed because, 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 (UN GHS, 2012, Document ID 0095). 
These proposed changes would align with the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, 
Document ID 0153).
Proposed Changes in Storage Column
Store Away From Other Materials
    For self-reactive substances and mixtures (C.4.21), self-heating 
substances and mixtures (C.4.24), and organic peroxides (C.4.28), OSHA 
proposes to revise the precautionary statement ``Store away from other 
materials'' to ``Store separately.'' OSHA believes that the revised 
statement is preferable because it is shorter and more appropriate. 
OSHA is also proposing 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. These proposed 
changes are consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Store Contents Under. . . .
    For pyrophoric liquids (C.4.22) and solids (C.4.23), OSHA proposes 
to delete a precautionary statement that says ``Store contents under . 
. . ,'' along with the instructional note that the chemical 
manufacturer, importer, or distributer is to specify the appropriate 
liquid or inert gas. 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 (UN GHS, 2012, 
Document ID 0152; UN GHS, 2012, Document ID 0153). OSHA believes 
placing the statement in the prevention column is 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. This modification was inadvertently omitted 
from the text in the GHS Rev. 7, and the U.S. will work with the U.N. 
to submit a paper to add this statement to pyrophoric liquids (C.4.22) 
and solids (C.4.23) in a future revision of the GHS.
Maintain Air Gap Between Stacks/Pallets
    For self-heating substances and mixtures (C.4.24), OSHA is 
proposing to revise the precautionary statement that currently says 
``[m]aintain air gap between stacks/pallets'' so it reads instead 
``[m]aintain air gap between stacks or pallets.'' The change would 
clarify that chemical manufacturers, importers or distributors are not 
to choose between ``stacks'' or ``pallets''

[[Page 9720]]

but are to include both words on the label. This proposed change would 
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Store in Corrosive Resistant/ . . . Container With a Resistant Inner 
Liner
    A precautionary statement for the corrosive to metals (C.4.29) 
class currently says to store in a ``corrosive resistant/ . . . 
container with a resistant inner liner.'' OSHA is proposing to change 
the word ``corrosive'' to ``corrosion'' because it is the technically 
correct term. In addition, a new conditional instruction would be 
inserted to indicate that the precautionary statement may be omitted if 
the statement ``Keep only in original packaging'' is included on the 
label. This would eliminate the redundancy of including both 
statements. These proposed changes would align with the GHS Rev. 7 (UN 
GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 
2012, Document ID 0153).
Instructional Notes
    For acute toxicity--inhalation (C.4.3) (category 1-3) and specific 
organ toxicity (single exposure, category 3) (C.4.11), OSHA is 
proposing 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 proposes 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 intent of these edits is to improve clarity 
and make the instruction more consistent with a newly added instruction 
for flammable liquids (C.4.19). This proposed change is consistent with 
the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document 
ID 0152; UN GHS, 2012, Document ID 0153).
    For flammable liquids (C.4.19), OSHA is proposing 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 is proposing 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 believes the precautionary statement ``Store in a 
well ventilated place'' is the appropriate level of protection. These 
proposed changes would align with the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, 
Document ID 0153).
    For explosives (C.4.14), OSHA is proposing minor edits to 
precautionary statements and instructions for storing in accordance 
with local/regional/national/international regulations. The edits are 
intended to clarify that the chemical manufacturer, importer, or 
distributer is to specify the applicable regulations. These proposed 
changes are consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
    Aerosols (C.4.16), self-reactive substances (C.4.21), self-heating 
substances and mixtures (C.4.24), and organic peroxides (C.4.28) 
currently include precautionary statements addressing storage 
temperatures not to be exceeded, with temperatures listed in degrees 
Celsius/Fahrenheit. The GHS has added an instruction that the chemical 
manufacturer should use the applicable temperature scale for the region 
they are supplying (UN GHS, 2017, Document ID 0060; UN GHS, 2012, 
Document ID 0152; UN GHS, 2012, Document ID 0153). In other OSHA 
standards, the primary temperature scale used is Fahrenheit. Therefore, 
OSHA is proposing to require only the Fahrenheit scale in the 
precautionary statements. However, the chemical manufacturer, importer 
or distributor would still be permitted to include the temperature in 
Celsius (as noted by parens ( )) in addition to Fahrenheit.
    In addition, for self-reactive substances and mixtures (C.4.21) and 
organic peroxides (C.4.28), OSHA proposes to add conditional 
instructions to two precautionary statements. The first conditional 
instruction would clarify that the statement to store in a well-
ventilated place should not be used for temperature-controlled 
substances and mixtures or organic peroxides because condensation and 
freezing may occur. The second would clarify that a storage temperature 
is only needed if temperature control is required or deemed necessary. 
OSHA also proposes moving the precautionary statement ``Keep cool'' to 
the prevention column, as discussed above under the section on proposed 
changes to the prevention column. These proposed changes would align 
with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, 
Document ID 0152; UN GHS, 2012, Document ID 0153).
Proposed Changes in Disposal Column
    For most of the health and physical hazards addressed by appendix 
C, the rule currently includes a precautionary statement to dispose of 
contents/container in accordance with local/regional/national/
international regulations (to be specified). OSHA is proposing 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. This proposed change would align with the GHS Rev. 7 (UN GHS, 
2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, 
Document ID 0153).
    The tables for explosives (C.4.14), except for hazard category 
division 1.6, currently include the precautionary statement to dispose 
of contents/container in accordance with local/regional/national/
international regulations (to be specified). However, 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. This is of particular 
concern for explosives such as fireworks, signal flares and ammunition. 
Ill-formulated advice on the label may lead to the disposal of such 
explosive waste in a way that poses a risk, e.g., to the workers that 
handle the waste (UN GHS, 2015, Document ID 0156). Therefore, OSHA is 
proposing 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.'' An instructional 
note would be added 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. The change is proposed 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. This proposed change is 
consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 
2015, Document ID 0214; UN GHS, 2015, Document ID 0213).
Proposed Revisions to Label Elements for OSHA Defined Hazards (C.4.31)
    OSHA is proposing a few changes to label elements for OSHA defined 
hazards (currently at C.4.30 and proposed to be renumbered as C.4.31).

[[Page 9721]]

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.
    First, OSHA is proposing to delete the entry for ``Pyrophoric 
Gas.'' In the GHS Rev. 7, pyrophoric gases are now a category under the 
hazard class of flammable gases, and OSHA proposes to include them 
there as well.
    OSHA is also proposing 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'' (UN GHS, 2009, Document ID 0085). In the GHS 
Rev. 5, the UN updated A.4.3.2.3 to include a 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 (combustible dust) (UN GHS, 2012, 
Document ID 0251). Subsequently, OSHA initiated UNSCEGHS discussions 
regarding combustible dust hazards. The UNSCEGHS adopted an annex 
(Annex 11) that provides additional guidance on hazard identification, 
the factors that contribute to a dust explosion hazard, and the need 
for risk assessment, prevention, mitigation, and communication (UN GHS, 
2017, Document ID 0157). OSHA is now proposing to allow either the 
previously required statement, ``may form combustible dust 
concentrations in air,'' or the statement suggested in the GHS Annex 4, 
``[m]ay form explosible dust-air mixture.'' OSHA is proposing 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 is designed to 
indicate that this language should be added when the material can 
create a combustible dust hazard during the processing or handling of 
the chemical. OSHA is not proposing any changes to the signal word of 
``warning'' or any pictogram requirements. These changes are the result 
of working papers presented to the UNSCEGHS meetings for discussion in 
December of 2017 (UN GHS, 2017, Document ID 0157).
GHS Revisions That OSHA Is Not Proposing To Adopt
    There are a small number of revisions in the GHS Rev. 7 that OSHA 
is not proposing to adopt for the HCS. In general, OSHA does 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 specific provisions in 
the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) that OSHA is not 
proposing to adopt.
    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 the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060) 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), the GHS Rev. 7 (UN GHS, 2017, 
Document ID 0060) 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. OSHA is not proposing to 
adopt these conditional instructions because it believes that proposed 
appendix C.2.4.8 (currently C.2.4.7), which provides instructions for 
the precedence of precautionary statements, already provides the 
necessary flexibility.
    In the GHS Rev. 7, the precautionary statements 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 (UN GHS, 2017, Document ID 0060). OSHA is not 
proposing 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 requests comments on its preliminary decision not to 
include the conditional instruction from the GHS.
    Under the HCS, a precautionary statement for gases under pressure 
(C.4.18) currently says ``Protect from sunlight.'' The GHS 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'' (UN 
GHS, 2017, Document ID 0060). These special packaging instructions 
under P200 are not applicable to cylinders used in the U.S; therefore, 
OSHA is not proposing to add this conditional instruction to C.4.18 (UN 
GHS, 2017, Document ID 0060).

F. Appendix D

    OSHA is proposing several changes to appendix D. These changes are 
being proposed to align with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060) to clarify existing requirements where stakeholders have 
expressed confusion, and to ensure consistency with updated scientific 
principles. A redline strike out version of appendix D, which reflects 
all of OSHA's proposed revisions, is available in the docket and on the 
OSHA website (OSHA HCS Redline 2020, Document ID 0222); https://www.osha.gov/dsg/hazcom/). This will allow interested parties to view 
all of the proposed changes in context. OSHA strongly encourages 
stakeholders to review that document in conjunction with the discussion 
of the proposed revisions below.
    In the introductory section of appendix D, OSHA proposes to add a 
sentence stating that while each section of the SDS must contain all of 
the specified information, preparers of SDSs are not required to 
present the information in any particular order within each section. 
OSHA proposes this change to help clarify that while all required 
information must be present on the SDS, there are no mandates about the 
order in which the information is presented within each section. 
Because the information within each section can be listed in any order, 
OSHA does not anticipate any increased burden on SDS preparers from 
this change.
    In section 1, Identification, OSHA is proposing revisions to 
clarify that the address and telephone number provided

[[Page 9722]]

on the SDS must be domestic. Although OSHA explained in a 2016 letter 
of interpretation that a U.S. telephone number and U.S. address are 
required for the SDS and label (Lee, 2016, Document ID 0090), OSHA 
believes it is important to codify this requirement in the text of the 
HCS to minimize any future confusion.
    In section 2, Hazard(s) identification, OSHA is proposing to 
clarify where and how chemical hazard information should be presented. 
First, OSHA proposes to clarify that paragrah (a) must include any 
hazards associated with a change in the chemical's physical form under 
normal conditions of use, an issue the agency has addressed in several 
LOIs (Cawthorn, 2014, Document ID 0238; McCarthy, 2015, Document ID 
0185; Fox, 2008; Document ID 0239). For example, for a chemical that 
poses a combustible dust hazard when processed (but not in the form in 
which it is shipped), the combustible dust hazard must be included in 
section 2(a). OSHA is also proposing a new paragraph (c) covering 
hazards identified under normal conditions of use that result from a 
chemical reaction (changing the chemical structure of the original 
substance or mixture). One example of such a reaction under normal 
conditions of use is the chemical change and subsequent physical 
effects of adding water to ready-mix concrete or cement, which creates 
additional hazards besides those present before the water is added 
(MST; 1995, Document ID 0253). This information is already required on 
the SDS (Boros, 2014, Document ID 0171), but OSHA believes that adding 
this language in paragraph (c) of section 2 would provide a clear and 
separate location for chemical manufacturers, distributors and 
importers to place this information. To accommodate the new material 
being proposed for paragraph (c), OSHA is proposing to move existing 
paragraphs (c) and (d) to paragraphs (d) and (e). OSHA notes that if it 
adopts the proposed revisions to section 2, 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, would be 
presented in paragraph (a), and new hazards created by a chemical 
reaction under normal conditions of use would be presented in paragraph 
(c). OSHA believes this would sufficiently differentiates the different 
types of hazards presented under normal conditions of use, but welcomes 
stakeholder comments on this issue.
    In section 3, OSHA is proposing several changes. Under the 
subheading ``For Substances (d)'' OSHA is proposing to add 
``(constituents)'' to clarify the term ``additives.'' OSHA intends 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 is also proposing to revise the information provided for 
mixtures. In addition to the information required for substances, 
section 3 requires the chemical name of all ingredients in a mixture 
that are classified as health hazards. OSHA proposes also requiring the 
CAS number or other unique identifier for these ingredients. CAS 
numbers are unique numerical identifiers assigned by the American 
Chemical Society (ACS) (CAS, 2020, Document ID 0173). CAS numbers are 
internationally recognized as being reliable and readily validated, are 
unique to only one compound, substance or chemical, and provide a 
common link between various nomenclature that may be used as 
descriptors for the substance or compound (UN, 2005, Document ID 0130; 
CAS, 2020, Document ID 0173). CAS numbers have been generated for all 
substances identified from the scientific literature from 1957 to the 
present, with some substances identified as far back as the early 1900s 
(CAS, 2020, Document ID 0173; UN, 2005, Document ID 0130). OSHA 
believes that this information provides the downstream user with 
important information, since it provides a unique descriptor of the 
chemical where the chemical identity may be ambiguous.
    OSHA is proposing an additional change in section 3 to reflect the 
proposed revision to paragraph (i) (Trade secrets), which would allow 
for concentration ranges to be withheld as a trade secret. When the 
concentration or concentration range is withheld as a trade secret, the 
chemical composition range would have to be provided in accordance with 
the prescribed concentration ranges in paragraphs (i)(1)(iv)(A) through 
(M). As explained in the summary and explanation section for paragraph 
(i), this would create an alignment with the WHMIS under Health Canada 
(Canadian Gazette II, 2018, Document ID 0101).
    Section 8 of the SDS includes information on exposure controls/
personal protection. Section 8(a) currently requires the SDS to include 
the OSHA permissible exposure limit (PEL), American Conference of 
Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV), 
and any other exposure limit used or recommended by the chemical 
manufacturer, importer, or employer preparing the SDS, when available. 
OSHA has received questions about whether this requirement applies to 
individual ingredients and constituents in the mixture, and has 
explained that it applies to any ingredient or constituent identified 
in section 3 of the SDS (McVeigh, 2013, Document ID 0088). To clarify 
this point, OSHA is proposing to revise section 8(a) to state that it 
applies to all ingredients or constituents listed in section 3. OSHA 
notes, however, that if the ingredient or constituent does not have an 
OSHA PEL, ACGIH TLV or any other exposure limit used or recommend by 
the SDS preparer, then the ingredient or constituent would not need to 
be listed in section 8.
    In addition, OSHA is also proposing to revise section 8 to add 
language indicating that SDS preparers must also include a ``range'' of 
exposure limits whenever a range is used or recommended by the chemical 
manufacturer, importer, or employer preparing the SDS. This revision 
would acknowledge new tools, such as occupational exposure banding or 
hazard banding methods described by NIOSH and the United Kingdom Health 
and Safety Executive (NIOSH, 2017, Document ID 0106; HSE, 2013, 
Document ID 0104). Hazard banding and occupational exposure banding 
provide a concentration range (band) based on toxicity and hazard 
information associated with a known chemical with similar properties; 
this range can inform appropriate risk management decisions where a 
specific occupational exposure limit (OEL) or permissible exposure 
limit (PEL) is not available or out of date (NIOSH, 2017, Document ID 
0106) This type of information has been developed and validated over 
the last few decades and these types of exposure ranges can provide 
hazard information on chemicals that can help reduce risk to workers, 
even if limited toxicological information is available (NIOSH, 2017, 
Document ID 0106). As noted by NIOSH and the U.S. EPA, more than 85,000 
chemicals are in commerce, with only approximately one thousand having 
been assessed for hazard and toxicity (either through an authoritative 
entity or peer-reviewed process) (NIOSH, 2017, Document ID 0106; EPA, 
2016, Document ID 0058).
    OSHA is proposing several updates to section 9, Physical and 
chemical properties. OSHA proposes to revise section 9 to align with 
the GHS Rev. 7 by listing the required physical and chemical properties 
of the chemical in the same order that appears in the GHS (UN GHS, 
2017, Document ID 0060). While OSHA does not require SDS

[[Page 9723]]

preparers to list the physical and chemical properties in any 
particular order, the agency is proposing this change in order to 
simplify preparation for those chemical manufacturers that may prepare 
SDSs for global distribution. Other proposed changes to section 9 
include: Replacing ``appearance'' with ``physical state'' and 
``color''; eliminating ``odor threshold'' and ``evaporation rate'' as 
separate required properties; adding the term ``kinematic'' to the 
property ``viscosity'' in order 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. Particle characteristics apply to solids only and the 
description should include the particle size (median and range) and, if 
available and appropriate, further properties such as size distribution 
(range), shape and aspect ratio, and specific surface area. Particle 
characteristics can be an important indicator of the potential for a 
solid particle to pose a hazard as particles that are less than 100 
microns increase the likelihood of exposure, especially through the 
route of inhalation (UN GHS, 2017, Document ID 0060; UN GHS, 2016; 
Document ID 0143, UN GHS, 2014, Document ID 0129).
    OSHA is proposing one change to section 10 of the SDS, Stability 
and reactivity. Section 10(c) requires preparers to include the 
possibility of hazardous reactions, and OSHA is proposing to clarify 
that this includes hazardous reactions associated with foreseeable 
emergencies. The proposed language is consistent with the language OSHA 
is proposing for paragraph (d)(1) (Hazard classification).
    In addition, OSHA is proposing to revise section 11, Toxicological 
information, to align with the GHS Rev. 7 (UN GHS, 2017, Document ID 
0060) by adding interactive effects as paragraph (e). In light of that 
proposed change, OSHA is proposing to move existing paragraph (e) to 
paragraph (f). OSHA also proposes to add a new paragraph (g), providing 
that when specific chemical data or information is not available, SDS 
preparers 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 structure activity relationships (SAR) 
to derive the toxicological information). SAR and QSAR (quantitative 
SAR) are predictive tools that utilize the properties from known 
chemical structures and properties in relation to their biological 
activity to predict activities and properties of untested chemicals 
based on their structural similarity to tested chemicals (EPA, 2016, 
Document ID 0179). Read across is another predictive technique that 
uses information on an endpoint from a known (tested) substance to 
predict endpoint information from a similar (but unknown or untested) 
substance (ECHA, 2016, Document ID 0178). Specific, detailed examples 
of read across, SAR and QSAR are provided on the OECD's website for 
chemical safety--assessment of chemicals (OECD, 2019, Document ID 0091; 
EPA, 2016, Document ID 0179; ECHA, 2016, Document ID 0178). This 
proposed change reflects the advancement in the scientific application 
of computational toxicology to hazard assessment and identification and 
would align with the GHS Rev. 7 (Ballabio, 2018, Document ID 0128; 
Idakwo, 2020, Document ID 0123; OECD, Document ID 0091; Mangiatoridi, 
2016, Document ID 0122; UN GHS, 2017, Document ID 0060).
    Finally, OSHA is proposing to change non-mandatory section 14(f), 
Transport information, to read ``Transport in bulk according to IMO 
instructions'' \60\ instead of ``Transport in bulk (according to Annex 
II of MARPOL 73/78 and the IBC Code)'' \61\ to be consistent with text 
in the GHS Rev. 7 (IMSBC, 2017, Document ID 0141). This change is an 
update to the reference that previously only covered liquefied gases in 
bulk. The proposed change would provide guidance that the information 
in section 14 covers all bulk transport regardless of the physical form 
of the cargo, in accordance with IMO instruments: e.g., Annex II or 
Annex V of MARPOL 73/789, the IBC code10, the IMSBC \62\ code and the 
IGC \63\ code. This change would also reflect standardization of 
conventions for the technology and safety upgrades in the IMO (a global 
standard-setting authority for the safety, security and environmental 
performance of international shipping under the United Nations).
---------------------------------------------------------------------------

    \60\ IMO Means the International Maritime Organization.
    \61\ MARPOL means the International Convention for prevention of 
Pollution from Ships.
    \62\ IMSBC Code means the International Maritime Solid Bulk 
Cargoes Code, as amended.
    \63\ IGC Code means The International Code of the Construction 
and Equipment of Ships Carrying Liquefied Gases in Bulk, as amended.
---------------------------------------------------------------------------

XVI. Authority and Signature

    This document was prepared under the direction of Loren Sweatt, 
Principal Deputy 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 58383-94); and 29 CFR part 1911.

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.

    Signed at Washington, DC, on December 28, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety 
and Health.

Proposed Amendments

    For the reasons set forth in the preamble, chapter XVII of title 
29, part 1910 of the Code of Federal Regulations is proposed to be 
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 by:
0
a. Revising the last sentence of paragraph (a)(4);
0
b. Adding paragraphs (h)(29) and (r)(2)(vi);
0
c. Redesignating paragraphs (r)(4) and (5) as paragraphs (r)(6) and 
(7), redesignating paragraph (r)(3) as paragraph (r)(4), and adding new 
paragraphs (r)(3) and (r)(5);
0
d. Revising paragraph (bb); and
0
e. Adding paragraphs (cc) and (dd).
    The revisions and additions read as follows:

[[Page 9724]]

Sec.  1910.6  Incorporation by reference.

    (a) * * *
    (4) * * * For information on the availability of this material at 
NARA, email fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
    (h) * * *
    (29) ASTM D 4359-90 (2019), Standard Test Method for Determining 
Whether a Material is a Liquid or a Solid, Re-approved 2019, IBR 
approved for Sec.  1910.1200.
* * * * *
    (r) * * *
    (2) * * *
    (vi) International Organization for Standardization, ISO Central 
Secretariat, Chemin de Blandonnet 8 CP 401--1214 Vernier, Geneva, 
Switzerland; Telephone: +41 22 749 01 11; Fax: +41 22 733 34 30; Email: 
central@iso.org; website: https://www.iso.org/store.html.
    (3) ISO 817:2014, Refrigerants--Designation and safety 
classification. Third Edition, June, 2014, IBR approved for appendix B 
to Sec.  1910.1200.
* * * * *
    (5) ISO 10156:2010, Gases and Gas Mixtures--Determination of Fire 
Potential and Oxidizing Ability for the Selection of Cylinder Valve 
Outlets, Third Edition, April, 2010, IBR approved for appendix B to 
Sec.  1910.1200.
* * * * *
    (bb) Except as noted, copies of the standards listed in this 
paragraph (bb) are available for purchase from United Nations 
Publications, P.O. Box 960 Herndon, VA 20172; telephone: 1-703-661-
1571; fax: 1-703-996-1010; email: order@un.org.
    (1) European Agreement Concerning the International Carriage of 
Dangerous Goods by Road (ADR), section 2.3.4 of Annex A, 2019, IBR 
approved for Sec.  1910.1200. Website: https://shop.un.org/series/european-agreement-concerning-international-carriage-dangerous-goods-road-adr.
    (2) 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. Copies 
available from:
    (i) Bernan, 15200 NBN Way, Blue Ridge Summit, PA 17214; telephone: 
1-800-865-3457; fax: 1-800-865-3450; email: [email protected]; 
website: http://www.bernan.com;
    (ii) Renouf Publishing Co. Ltd., 812 Proctor Avenue, Ogdensburg, NY 
13669-2205; telephone: 1-888-551-7470; Fax: 1-888-551-7471; email: 
orders@renoufbooks.com; website: http://www.renoufbooks.com; and
    (iii) United Nations Publications, Customer Service, c/o National 
Book Network, 15200 NBN Way, P.O. Box 190, Blue Ridge Summit, PA 17214; 
telephone: 1-888-254-4286; fax: 1-800-338-4550; email: 
unpublications@nbnbooks.com.
    (3) UN ST/SG/AC.10/30/Rev.6, The UN Recommendations on the 
Transport of Dangerous Goods, Manual of Tests and Criteria, Sixth 
Revised Edition, 2015, IBR approved for appendix B to Sec.  1910.1200. 
Website: https://www.unece.org/trans/danger/publi/manual/manual_e.html.
    (cc) The following material is available for purchase from 
International Electrotechnical Commission through ANSI, 25 West 43rd 
Street, 4th Floor, New York, NY 10036; telephone: 1-212-642-4963; fax: 
1-212-398-0023; website: https://www.iec.ch.
    (1) IEC 60079-20-1 ed. 1.0 (2010-01) Explosive atmospheres--Part 
20-1: Material characteristics for gas and vapor classification--Test 
methods and data, IBR approved for appendix B to Sec.  1910.1200.
    (2) [Reserved]
    (dd) The following material is available for purchase from German 
Institute for Standardization (DIN) through ANSI, 25 West 43rd Street, 
4th Floor, New York, NY 10036; telephone: 1-212-642-4963; fax: 1-212-
398-0023; https://din.de/en/about-standards/buy-standard.
    (1) DIN 51794--Determining the ignition temperature of petroleum 
products, 2003, IBR approved for appendix B to Sec.  1910.1200.
    (2) [Reserved]
0
3. Amend Sec.  1910.1200:
0
a. By revising paragraphs (a)(1) and (b)(6)(x);
0
b. In paragraph (c):
0
i. By removing the period following the subject heading and adding a 
colon in its place;
0
ii. By adding in alphabetical order definitions for ``Bulk shipment'' 
and ``Combustible dust'';
0
iii. By revising the definition of ``Exposure or exposed'';
0
iv. By adding in alphabetical order a definition for ``Gas'';
0
v. By revising the definition of ``Hazardous chemical'';
0
vi. By adding in alphabetical order definitions for ``Immediate outer 
package'' and ``Liquid'';
0
vii. By revising the definition of ``Physical hazard'';
0
viii. By adding in alphabetical order a definition for ``Physician or 
other licensed health are professional (PLHCP)'';
0
ix. By removing the definition of ``Pyrophoric gas''; and
0
x. By adding in alphabetical order definitions for ``Released for 
shipment'' and ``Solid'';
0
c. By revising paragraphs (d)(1), (e)(4), and (f)(1), (5), and (11);
0
d. By adding paragraph (f)(12);
0
e. By revising paragraphs (g)(2) introductory text, (g)(10), (i)(1) and 
(2), (i)(3) introductory text, and (j); and
0
f. By revising appendices A through D.
    The revisions and additions read as follows:

Sec.  1910.1200   Hazard communication.

    (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), 
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) * * *
    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).
* * * * *
    Combustible dust means 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.
* * * * *
    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).
* * * * *
    Gas means a substance which--at 122 [deg]F (50 [deg]C) has a vapor 
pressure greater than 43.51 PSI (300 kPa) (absolute); or

[[Page 9725]]

is completely gaseous at 68 [deg]F (20 [deg]C) at a standard pressure 
of 14.69 PSI (101.3 kPa).
* * * * *
    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.
* * * * *
    Immediate outer package means the first package enclosing the 
container of hazardous chemical.
* * * * *
    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). A viscous substance or mixture for 
which a specific melting point cannot be determined shall be subjected 
to ASTM D 4359-90 (2019) (Standard Test Method for Determining Whether 
a Material Is a Liquid or a Solid) (incorporated by reference; see 
Sec.  1910.6); or to the test for determining fluidity (penetrometer 
test) prescribed in the European Agreement Concerning the International 
Carriage of Dangerous Goods by Road (ADR), section 2.3.4 of Annex A 
(2019) (incorporated by reference; see Sec.  1910.6).
* * * * *
    Physical hazard means a chemical that is classified as posing one 
of the following hazardous effects: Explosive; flammable (gases, 
liquids, or solids); aerosols; oxidizer (liquid, solid or gas); 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.
* * * * *
    Released for shipment means a chemical that has been packaged and 
labeled in the manner in which it will be distributed or sold.
* * * * *
    Solid means a substance or mixture which does not meet the 
definitions of liquid or gas.
* * * * *
    (d) * * *
    (1) Chemical manufacturers and importers shall evaluate chemicals 
produced in their workplaces or imported by them to classify the 
chemicals in accordance with this section. For each chemical, the 
chemical manufacturer or importer shall determine the hazard classes, 
and where appropriate, the category of each class that apply to the 
chemical being classified under normal conditions of use and 
foreseeable emergencies. 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. 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 resulting from a reaction with 
other chemicals under normal conditions of use 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, address, and telephone number of the chemical 
manufacturer, importer, or other responsible party; and
    (vii) Date chemical is released for shipment.
* * * * *
    (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. 1801 et seq.) 
and regulations issued under that Act by the Department of 
Transportation.
    (ii) The label for bulk shipments of hazardous chemicals may be on 
the immediate container or may 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 shipment.
    (iii) Where a pictogram required by the Department of 
Transportation under title 49 of the Code of Federal Regulations 
appears on the label for a shipped container, the pictogram specified 
in appendix C.4 of this section for the same hazard is not required on 
the label.
* * * * *
    (11) Release for shipment. 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. 
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. 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 (f)(12) 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

[[Page 9726]]

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) * * *
    (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):
* * * * *
    (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) * * *
    (1) The chemical manufacturer, importer, or employer may withhold 
the specific chemical identity, including the chemical name, other 
specific identification of a hazardous chemical, 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 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, 
a single range created by the combination of two applicable consecutive 
ranges (e.g., between (i)(1)(iv)(A) and (G)) 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) 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).
    (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:
* * * * *
    (j) Dates. (1) This section is effective [DATE 60 DAYS AFTER DATE 
OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER].
    (2) Chemical manufacturers, importers, and distributors evaluating 
substances shall be in compliance with all modified provisions of this 
section no later than [DATE ONE YEAR AFTER EFFECTIVE DATE OF FINAL 
RULE].
    (3) Chemical manufacturers, importers, and distributors evaluating 
mixtures shall be in compliance with all modified provisions of this 
section no later than 24 months after [DATE TWO YEARS AFTER EFFECTIVE 
DATE OF FINAL RULE].
* * * * *

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.

[[Page 9727]]

    A.0.2.3 The term ``scientifically validated'' refers to the 
process by which the reliability and the relevance of a procedure 
are established for a particular purpose. Any test that determines 
hazardous properties, which is conducted according to recognized 
scientific principles, can be used for purposes of a hazard 
determination for health hazards. Test conditions need to be 
standardized so that the results are reproducible with a given 
substance, and the standardized test yields ``valid'' data for 
defining the hazard class of concern.
    A.0.2.4 Existing test data are acceptable for classifying 
chemicals, although expert judgment also may be needed for 
classification purposes.
    A.0.2.5 The effect of a chemical on biological systems is 
influenced, by the physico-chemical properties of the substance and/
or ingredients of the mixture and the way in which ingredient 
substances are biologically available. A chemical need not be 
classified when it can be shown by conclusive experimental data from 
scientifically validated test methods that the chemical is not 
biologically available.
    A.0.2.6 For classification purposes, epidemiological data and 
experience on the effects of chemicals on humans (e.g., occupational 
data, data from accident databases) shall be taken into account in 
the evaluation of human health hazards of a chemical.

A.0.3 Classification Based on Weight of Evidence

    A.0.3.1 For some hazard classes, classification results directly 
when the data satisfy the criteria. For others, classification of a 
chemical shall be determined on the basis of the total weight of 
evidence using expert judgment. This means that all available 
information bearing on the classification of hazard shall be 
considered together, including the results of valid in vitro tests, 
relevant animal data, and human experience such as epidemiological 
and clinical studies and well-documented case reports and 
observations.
    A.0.3.2 The quality and consistency of the data shall be 
considered. Information on chemicals related to the material being 
classified shall be considered as appropriate, as well as site of 
action and mechanism or mode of action study results. Both positive 
and negative results shall be considered together in a single 
weight-of-evidence determination.
    A.0.3.3 Positive effects which are consistent with the criteria 
for classification, whether seen in humans or animals, shall 
normally justify classification. Where evidence is available from 
both humans and animals and there is a conflict between the 
findings, the quality and reliability of the evidence from both 
sources shall be evaluated in order to resolve the question of 
classification. Reliable, good quality human data shall generally 
have precedence over other data. However, even well-designed and 
conducted epidemiological studies may lack a sufficient number of 
subjects to detect relatively rare but still significant effects, or 
to assess potentially confounding factors. Therefore, positive 
results from well-conducted animal studies are not necessarily 
negated by the lack of positive human experience but require an 
assessment of the robustness, quality and statistical power of both 
the human and animal data.
    A.0.3.4 Route of exposure, mechanistic information, and 
metabolism studies are pertinent to determining the relevance of an 
effect in humans. When such information raises doubt about relevance 
in humans, a lower classification may be warranted. When there is 
scientific evidence demonstrating that the mechanism or mode of 
action is not relevant to humans, the chemical should not be 
classified.
    A.0.3.5 Both positive and negative results are considered 
together in the weight of evidence determination. However, a single 
positive study performed according to good scientific principles and 
with statistically and biologically significant positive results may 
justify classification.

A.0.4 Considerations for the Classification of Mixtures

    A.0.4.1 Except as provided in A.0.4.2, the process of 
classification of mixtures is based on the following sequence:
    (a) Where test data are available for the complete mixture, the 
classification of the mixture will always be based on those data;
    (b) Where test data are not available for the mixture itself, 
the bridging principles designated in each health hazard chapter of 
this appendix shall be considered for classification of the mixture;
    (c) If test data are not available for the mixture itself, and 
the available information is not sufficient to allow application of 
the above-mentioned bridging principles, then the method(s) 
described in each chapter for estimating the hazards based on the 
information known will be applied to classify the mixture (e.g., 
application of cut-off values/concentration limits).
    A.0.4.2 An exception to the above order or precedence is made 
for Carcinogenicity, Germ Cell Mutagenicity, and Reproductive 
Toxicity. For these three hazard classes, mixtures shall be 
classified based upon information on the ingredient substances, 
unless on a case-by-case basis, justification can be provided for 
classifying based upon the mixture as a whole. See chapters A.5, 
A.6, and A.7 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

[[Page 9728]]

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 9729]]

[GRAPHIC] [TIFF OMITTED] TP16FE21.077

    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

[[Page 9730]]

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 the chemical must be labelled 
with the hazard statement ``corrosive to the respiratory tract.''
    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 and A.9).

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:
[GRAPHIC] [TIFF OMITTED] TP16FE21.080

[[Page 9731]]

    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

    A.1.3.5.1 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 toxicity hazard categories, or have an oral or 
dermal LD50 greater than 2,000 but less than or equal to 
5,000 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] TP16FE21.081

where:

Ci = concentration of ingredient i
n ingredients and i is running from 1 to n
ATEi = acute toxicity estimate of ingredient i.

    A.1.3.6.2 Data are not available for one or more ingredients of 
the mixture
    A.1.3.6.2.1 Where an ATE is not available for an individual 
ingredient of the mixture, but available information provides a 
derived conversion value, the formula in A.1.3.6.1 may be applied. 
This information may include evaluation of:
    (a) Extrapolation between oral, dermal and inhalation acute 
toxicity estimates. Such an evaluation requires appropriate 
pharmacodynamic and pharmacokinetic data;
    (b) Evidence from human exposure that indicates toxic effects 
but does not provide lethal dose data;
    (c) Evidence from any other toxicity tests/assays available on 
the substance that indicates toxic acute effects but does not 
necessarily provide lethal dose data; or
    (d) Data from closely analogous substances using structure/
activity relationships.
    A.1.3.6.2.2 This approach requires substantial supplemental 
technical information, and a highly trained and experienced expert, 
to reliably estimate acute toxicity. If sufficient information is 
not available to reliably estimate acute toxicity, proceed to the 
provisions of A.1.3.6.2.4.
    A.1.3.6.2.3 In the event that an ingredient with unknown acute 
toxicity is used in a mixture at a concentration >=1%, and the 
mixture has not been classified based on testing of the mixture as a 
whole, the mixture cannot be attributed a definitive acute toxicity 
estimate. In this situation the mixture is classified based on the 
known ingredients only. Note: A statement that x percent of the 
mixture consists of ingredient(s) of unknown acute (oral/dermal/
inhalation) toxicity is required on the label and safety data sheet 
in such cases; see appendix C to this section, Allocation of Label 
Elements and appendix D to this section, Safety Data Sheets.)
    A.1.3.6.2.4 If the total concentration of the relevant 
ingredient(s) with unknown acute toxicity is <=10% then the formula 
presented in A.1.3.6.1 must be used. If the total concentration of 
the relevant ingredient(s) with unknown acute toxicity is >10%, the 
formula presented in A.1.3.6.1 is corrected to adjust for the 
percentage of the unknown ingredient(s) as follows:
[GRAPHIC] [TIFF OMITTED] TP16FE21.082

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 exposure to a substance or 
mixture.
    Skin irritation refers to the production of reversible damage to 
the skin occurring after exposure to a substance or mixture.
    A.2.1.2 Skin corrosion/irritation shall be classified using a 
tiered approach as detailed in figure A.2.1. 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 
skin corrosion/irritation is considered together, including the 
results of appropriate scientifically validated in-vitro tests, 
relevant animal data, and human data

[[Page 9732]]

such as epidemiological and clinical studies and well-documented 
case reports and observations.

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)
    (b) Category 2 (skin irritation)

A.2.2.1 Classification Based on Standard Animal Test Data

A.2.2.1.1 Skin Corrosion

    A.2.2.1.2 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 
exposure up to a 4-hour duration.
    A.2.2.1.3 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.2.3.

A.2.2.2 Skin Irritation

    A.2.2.2.1 A single irritant category (Category 2) is presented 
in the Table A.2.2. A substance is irritant to skin when it produces 
reversible damage to the skin following its application for up to 4 
hours.
    The major criterion for the irritant category is that at least 2 
tested animals have a mean score of >=2.3 <=4.0.
    A.2.2.2.2 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.2.2.2.3 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.2.2.2.4 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 might be designated as an irritant if at least 1 of 3 
tested animals shows a very elevated mean score throughout the 
study, including lesions persisting at the end of an observation 
period of normally 14 days. Other responses could also fulfill 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 Category a b
------------------------------------------------------------------------
                                                     Criteria
------------------------------------------------------------------------
Irritant (Category 2)...................  (1) Mean score of >=2.3 <=4.0
                                           for erythema/eschar or for
                                           edema in at least 2 of 3
                                           tested animals from gradings
                                           at 24, 48 and 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
                                           least 2 animals, particularly
                                           taking into account alopecia
                                           (limited area),
                                           hyperkeratosis, hyperplasia,
                                           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.2.3 Classification in a Tiered Approach

    A.2.3.1 A tiered approach to the evaluation of initial 
information shall be used (Figure A.2.1) recognizing that not all 
elements may be relevant.
    A.2.3.2 Existing human and animal data including information 
from single or repeated exposure should be the first line of 
evaluation, as they give information directly relevant to effects on 
the skin.
    A.2.3.3 Acute dermal toxicity data may be used for 
classification. If a substance is highly toxic by the dermal route, 
a skin corrosion/irritation study may not be practicable 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 are made of skin corrosion/irritation in 
acute toxicity studies and are observed up through the limit dose, 
these data may be used for classification provided that the 
dilutions used and species tested are equivalent. Solid substances 
(powders) may become corrosive or irritant when moistened or in 
contact with moist skin or mucous membranes.
    A.2.3.4 In vitro alternatives that have been scientifically 
validated shall be used to make classification decisions.
    A.2.3.5 Likewise, pH extremes like <=2 and >=11.5 may indicate 
skin effects, 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 or mixture may not be corrosive despite the low or high pH 
value, this needs to be confirmed by other data, preferably data 
from an appropriate validated in vitro test.
    A.2.3.6 In some cases sufficient information may be available 
from structurally related substances to make classification 
decisions.
    A.2.3.7 The tiered approach explains how to organize existing 
information on a substance and to make a weight of evidence decision 
about hazard assessment and hazard classification (ideally without 
conducting new animal tests). 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.
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[[Page 9734]]

[GRAPHIC] [TIFF OMITTED] TP16FE21.084

[[Page 9735]]

BILLING CODE 4510-26-C

A.2.4 Classification Criteria for Mixtures

A.2.4.1 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    A.2.4.1.1 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).
    A.2.4.1.2 When considering testing of the mixture, classifiers 
must use a tiered approach as included in the criteria for 
classification of substances for skin corrosion and 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 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, then further evaluation may be necessary.

A.2.4.2 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.2.4.2.1 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.2.4.3 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.2.4.3.1 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.2.4.3.2 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.2.4.3.3 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.2.4.3.4 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.2.4.3.1 and A.2.4.3.2 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.2.4.3.5 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.2.4.3.6 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 Category 2.................  ................  >=10%
----------------------------------------------------------------------------------------------------------------
Note: Where data are available and 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 mixturemust 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 Category 1 without
  sub-categorization, the mixture must be classified as Category 1 without sub-categorization if the sum of all
  ingredients corrosive to skin is >=5%.

     Table A.2.4--Concentration of Ingredients of a Mixture When the
Additivity Approach Does Not Apply, That Would Trigger Classification of
                    the Mixture as Hazardous to Skin
------------------------------------------------------------------------
                                                      Mixture classified
           Ingredient:              Concentration:         as: Skin
------------------------------------------------------------------------
Acid with pH <=2.................              >=1%  Category 1.
Base with pH >=11.5..............              >=1%  Category 1.
Other corrosive (Category 1)                   >=1%  Category 1.
 ingredient.
Other irritant (Category 2)                    >=3%  Category 2.
 ingredient, including acids and
 bases.
------------------------------------------------------------------------

[[Page 9736]]

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/           A substance that produces:
 Irreversible 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.3.2.2 Eye irritation (Category 2)/Reversible effects on the 
eye.
    A.3.2.2.1 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.3.2.3 For those substances where there is pronounced 
variability among animal responses, this information may 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 edema (chemosis) >=2
                                calculated as the mean scores following
                                 grading at 24, 48 and 72 hours after
                                 instillation of the test material, and
                                 which fully reverses within an
                                 observation period of normally 21 days.
Category 2B...................  Within Category 2A an eye irritant is
                                 considered mildly irritating to eyes
                                 (Category 2B) when the effects listed
                                 above are fully reversible within 7
                                 days of observation.
------------------------------------------------------------------------
\a\ Grading criteria are understood as described in OECD Test Guideline
  405.

A.3.3 Classification in a Tiered Approach

    A.3.3.1 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.3.3.2 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.3.3.3 In vitro alternatives that have been scientifically 
validated and accepted shall be used to make classification 
decisions.
    A.3.3.4 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.

[[Page 9737]]

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 needs to be confirmed by other data, preferably 
by data from an appropriate validated in vitro test.
    A.3.3.5 In some cases sufficient information may be available 
from structurally related substances to make classification 
decisions.
    A.3.3.6 The tiered approach explains 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.
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[GRAPHIC] [TIFF OMITTED] TP16FE21.086

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[GRAPHIC] [TIFF OMITTED] TP16FE21.087

BILLING CODE 4510-26-C

A.3.4 Classification Criteria for Mixtures

A.3.4.1 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    A.3.4.1.1 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.3.4.1.2 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.3.4.2 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.3.4.2.1 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.3.4.3 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.3.4.3.1 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.3.4.3.2 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.3.4.3.3 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.3.4.3.4 Particular care must be taken when classifying certain 
types of chemicals such as acids and bases, inorganic salts, 
aldehydes, phenols, and surfactants. The approach explained in 
A.3.4.3.1 and A.3.4.3.2 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.3.4.1) 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.3.4.3.5 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.3.3, 
Figure A.3.1 and explained in detail in this chapter.
    A.3.4.3.6 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).

[[Page 9741]]

  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 -----------------------------------------
              as                  Serious eye damage     Eye irritation
                               -----------------------------------------
                                      Category 1         Category 2/2A
------------------------------------------------------------------------
Skin corrosion (Category 1) +                   >=3%   >=1% but <3%.
 Serious eye damage (Category
 1) \a\.
Eye irritation (Category 2)...  .....................  \b\ >=10%.
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 as:
           Ingredient                  (%)
------------------------------------------------------------------------
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.
---------------------------------------------------------------------------

    \1\ 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.

     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
    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.

[[Page 9742]]

    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.4.2.1.2.3 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.4.2.1.3.1 Data from appropriate animal studies \2\ which may 
be indicative of the potential of a substance to cause sensitization 
by inhalation in humans \3\ may include:
---------------------------------------------------------------------------

    \2\ At this writing, recognized and validated animal models for 
the testing of respiratory hypersensitivity are not available. Under 
certain circumstances, data from animal studies may provide valuable 
information in a weight of evidence assessment.
    \3\ The mechanisms by which substances induce symptoms of asthma 
are not yet fully known. For preventive measures, these substances 
are considered respiratory sensitizers. However, if on the basis of 
the evidence, it can be demonstrated that these substances induce 
symptoms of asthma by irritation only in people with bronchial 
hyperactivity, they should not be considered as respiratory 
sensitizers.
---------------------------------------------------------------------------

    (a) Measurements of Immunoglobulin E (IgE) and other specific 
immunological parameters, for example in mice.
    (b) Specific pulmonary responses in guinea pigs.

A.4.2.2 Skin Sensitizers

    A.4.2.2.1 Hazard categories
    A.4.2.2.1.1 Effects seen in either humans or animals will 
normally justify classification in a weight of evidence approach for 
skin sensitizers. Substances may be allocated to one of the two sub-
categories 1A or 1B using a weight of evidence approach in 
accordance with the criteria given in Table A.4.2 and on the basis 
of reliable and good quality evidence from human cases or 
epidemiological studies and/or observations from appropriate studies 
in experimental animals according to the guidance values provided in 
A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 1A and in A.4.2.2.2.2 
and A.4.2.2.3.3 for sub-category 1B.
    A.4.2.2.1.2 Where data are not sufficient for sub-
categorization, skin sensitizers shall be classified in Category 1.

  Table A.4.2--Hazard Category and Sub-Categories for Skin Sensitizers
------------------------------------------------------------------------
          Category 1:                        Skin sensitizer
------------------------------------------------------------------------
                                A substance is classified as a skin
                                 sensitizer:
                                (a) If there is evidence in humans that
                                 the substance can lead to sensitization
                                 by skin contact in a substantial number
                                 of persons, or
                                (b) if there are positive results from
                                 an appropriate animal test.
Sub-category 1A:..............  Substances showing a high frequency of
                                 occurrence in humans and/or a high
                                 potency in animals can be presumed to
                                 have the potential to produce
                                 significant sensitization in humans.
                                 Severity of reaction may also be
                                 considered.
Sub-category 1B:..............  Substances showing a low to moderate
                                 frequency of occurrence in humans and/
                                 or a low to moderate potency in animals
                                 can be presumed to have the potential
                                 to produce sensitization in humans.
                                 Severity of reaction may also be
                                 considered.
------------------------------------------------------------------------

    A.4.2.2.2 Human evidence
    A.4.2.2.2.1 Human evidence for sub-category 1A may include:
    (a) Positive responses at <=500 [micro]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 [micro]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 Table A.4.3 below:

          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.

[[Page 9743]]

 
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 the following Table A.4.4:

          Table A.4.4--Animal Test Results for Sub-Category 1B
------------------------------------------------------------------------
             Assay                              Criteria
------------------------------------------------------------------------
Local lymph node assay........  EC3 value >2%.
Guinea pig maximization test..  >=30% to <60% responding at >0.1% to
                                 <=1% intradermal induction dose or
                                 >=30% responding at >1% intradermal
                                 induction dose.
Buehler assay.................  >=15% to <60% responding at >0.2% to
                                 <=20% topical induction dose or >=15%
                                 responding at >20% topical induction
                                 dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
  required to induce a stimulation index of 3 in the local lymph node
  assay.

    A.4.2.2.4 Specific considerations
    A.4.2.2.4.1 For classification of a substance, evidence shall 
include one or more of the following using a weight of evidence 
approach:
    (a) Positive data from patch testing, normally obtained in more 
than one dermatology clinic;
    (b) Epidemiological studies showing allergic contact dermatitis 
caused by the substance. Situations in which a high proportion of 
those exposed exhibit characteristic symptoms are to be looked at 
with special concern, even if the number of cases is small;
    (c) Positive data from appropriate animal studies;
    (d) Positive data from experimental studies in humans (See 
paragraph A.0.2.6 of this appendix);
    (e) Well documented episodes of allergic contact dermatitis, 
normally obtained in more than one dermatology clinic;
    (f) Severity of reaction.
    A.4.2.2.4.2 Evidence from animal studies is usually much more 
reliable than evidence from human exposure. However, in cases where 
evidence is available from both sources, and there is conflict 
between the results, the quality and reliability of the evidence 
from both sources must be assessed in order to resolve the question 
of classification on a case-by-case basis. Normally, human data are 
not generated in controlled experiments with volunteers for the 
purpose of hazard classification but rather as part of risk 
assessment to confirm lack of effects seen in animal tests. 
Consequently, positive human data on skin sensitization are usually 
derived from case-control or other, less defined studies. Evaluation 
of human data must, therefore, be carried out with caution as the 
frequency of cases reflect, in addition to the inherent properties 
of the substances, factors such as the exposure situation, 
bioavailability, individual predisposition and preventive measures 
taken. Negative human data should not normally be used to negate 
positive results from animal studies. For both animal and human 
data, consideration should be given to the impact of vehicle.
    A.4.2.2.4.3 If none of the above-mentioned conditions are met, 
the substance need not be classified as a skin sensitizer. However, 
a combination of two or more indicators of skin sensitization, as 
listed below, may alter the decision. This shall be considered on a 
case-by-case basis.
    (a) Isolated episodes of allergic contact dermatitis;
    (b) Epidemiological studies of limited power, e.g., where 
chance, bias or confounders have not been ruled out fully with 
reasonable confidence;
    (c) Data from animal tests, performed according to existing 
guidelines, which do not meet the criteria for a positive result 
described in A.4.2.2.3, but which are sufficiently close to the 
limit to be considered significant;
    (d) Positive data from non-standard methods;
    (e) Positive results from close structural analogues.
    A.4.2.2.4.4 Immunological contact urticaria
    A.4.2.2.4.4.1 Substances meeting the criteria for classification 
as respiratory sensitizers may, in addition, cause immunological 
contact urticaria. Consideration shall be given to classifying these 
substances as skin sensitizers.
    A.4.2.2.4.4.2 Substances which cause immunological contact 
urticaria without meeting the criteria for respiratory sensitizers 
shall be considered for classification as skin sensitizers.
    A.4.2.2.4.4.3 There is no recognized animal model available to 
identify substances which cause immunological contact urticaria. 
Therefore, classification will normally be based on human evidence, 
similar to that for skin sensitization.

A.4.3 Classification Criteria for Mixtures

A.4.3.1 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    When reliable and good quality evidence, as described in the 
criteria for substances, from human experience or appropriate 
studies in experimental animals, is available for the mixture, then 
the mixture shall be classified by weight of evidence evaluation of 
these data. Care must be exercised in evaluating data on mixtures 
that the dose used does not render the results inconclusive.

A.4.3.2 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.4.3.2.1 Where the mixture itself has not been tested to 
determine its sensitizing properties, but there are sufficient data 
on both the individual ingredients and similar tested mixtures to 
adequately characterize the hazards of the mixture, these data will 
be used in accordance with the following agreed bridging principles 
as found in paragraph A.0.5 of this appendix: Dilution, Batching, 
Concentration of mixtures, Interpolation within one hazard category/
subcategory, Substantially similar mixtures, and Aerosols.

A.4.3.3 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    The mixture shall be classified as a respiratory or skin 
sensitizer when at least one ingredient has been classified as a 
respiratory or skin sensitizer and is present at or above the 
appropriate cut-off value/concentration limit for the specific 
endpoint as shown in Table A.4.5.

[[Page 9744]]

  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 states
                                                                 (%)             Gas                (%)
----------------------------------------------------------------------------------------------------------------
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 structural 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/genotoxicity 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 chemical structure activity relationship
  to known germ cell mutagens, should be considered for classification
  as Category 2 mutagens.

    A.5.2.2 Specific considerations for classification of substances 
as germ cell mutagens:
    A.5.2.2.1 To arrive at a classification, test results are 
considered from experiments determining mutagenic and/or genotoxic 
effects in germ and/or somatic cells of exposed animals. Mutagenic 
and/or genotoxic effects determined in in vitro tests shall also be 
considered.
    A.5.2.2.2 The system is hazard based, classifying chemicals on 
the basis of their intrinsic ability to induce mutations in germ 
cells. The scheme is, therefore, not meant for the (quantitative) 
risk assessment of chemical substances.
    A.5.2.2.3 Classification for heritable effects in human germ 
cells is made on the basis of scientifically validated tests. 
Evaluation of the test results shall be done using expert judgment 
and all the available evidence shall be weighed for classification.
    A.5.2.2.4 The classification of substances shall be based on the 
total weight of evidence available, using expert judgment. In those 
instances where a single well-conducted test is used for 
classification, it shall provide clear and unambiguously positive 
results. The relevance of the route of exposure used in the study of 
the substance compared to the route of human exposure should also be 
taken into account.

A.5.3 Classification Criteria for Mixtures 5
---------------------------------------------------------------------------

    \5\ It should be noted that the classification criteria for 
health hazards usually include a tiered scheme in which test data 
available on the complete mixture are considered as the first tier 
in the evaluation, followed by the applicable bridging principles, 
and lastly, cut-off values/concentration limits or additivity. 
However, this approach is not used for Germ Cell Mutagenicity. These 
criteria for Germ Cell Mutagenicity consider the cut-off values/
concentration limits as the primary tier and allow the 
classification to be modified only on a case-by-case evaluation 
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------

A.5.3.1 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.5.3.1.1 Classification of mixtures shall be based on the 
available test data for the

[[Page 9745]]

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 mutagen     Category 2 mutagen
----------------------------------------------------------------------------------------------------------------
Category 1A/B mutagen.............................................                >=0.1%   .....................
Category 2 mutagen................................................  .....................                >=1.0%
----------------------------------------------------------------------------------------------------------------
Note: The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well
  as gases (v/v units).

A.5.3.2 Classification of Mixtures When Data Are Available for the 
Mixture Itself

    The classification may be modified on a case-by-case basis based 
on the available test data for the mixture as a whole. In such 
cases, the test results for the mixture as a whole must be shown to 
be conclusive taking into account dose and other factors such as 
duration, observations and analysis (e.g., statistical analysis, 
test sensitivity) of germ cell mutagenicity test systems.

A.5.3.3 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.5.3.3.1 Where the mixture itself has not been tested to 
determine its germ cell mutagenicity hazard, but there are 
sufficient data on both the individual ingredients and similar 
tested mixtures to adequately characterize the hazards of the 
mixture, these data will be used in accordance with the following 
bridging principles as found in paragraph A.0.5 of this appendix: 
Dilution, Batching, and Substantially similar mixtures.

A.5.4 Examples of Scientifically Validated Test Methods

    A.5.4.1 Examples of in vivo heritable germ cell mutagenicity 
tests are:
    (a) Rodent dominant lethal mutation test (OECD 478)
    (b) Mouse heritable translocation assay (OECD 485)
    (c) Mouse specific locus test
    A.5.4.2 Examples of in vivo somatic cell mutagenicity tests are:
    (a) Mammalian bone marrow chromosome aberration test (OECD 475)
    (b) Mammalian erythrocyte micronucleus test (OECD 474)
    A.5.4.3 Examples of mutagenicity/genotoxicity tests in germ 
cells are:
    (a) Mutagenicity tests:
    (i) Mammalian spermatogonial chromosome aberration test (OECD 
483)
    (ii) Spermatid micronucleus assay
    (b) Genotoxicity tests:
    (i) Sister chromatid exchange analysis in spermatogonia
    (ii) Unscheduled DNA synthesis test (UDS) in testicular cells
    A.5.4.4 Examples of genotoxicity tests in somatic cells are:
    (a) Liver Unscheduled DNA Synthesis (UDS) in vivo (OECD 486)
    (b) Mammalian bone marrow Sister Chromatid Exchanges (SCE)
    A.5.4.5 Examples of in vitro mutagenicity tests are:
    (a) In vitro mammalian chromosome aberration test (OECD 473)
    (b) In vitro mammalian cell gene mutation test (OECD 476)
    (c) Bacterial reverse mutation tests (OECD 471)
    A.5.4.6 As new, scientifically validated tests arise, these may 
also be used in the total weight of evidence to be considered.

A.6 Carcinogenicity

A.6.1 Definitions

    Carcinogenicity refers to the induction of cancer or an increase 
in the incidence of cancer occurring after exposure to a substance 
or mixture. Substances and mixtures which have induced benign and 
malignant tumors in well-performed experimental studies on animals 
are considered also to be presumed or suspected human carcinogens 
unless there is strong evidence that the mechanism of tumor 
formation is not relevant for humans.
    Classification of a substance or mixture as posing a 
carcinogenic hazard is based on its inherent properties and does not 
provide information on the level of the human cancer risk which the 
use of the substance or mixture may represent.

A.6.2 Classification Criteria for Substances 6
---------------------------------------------------------------------------

    \6\ See Non-mandatory appendix F of this section, part A for 
further guidance regarding hazard classification for 
carcinogenicity. This appendix is consistent with the GHS and is 
provided as guidance excerpted from the International Agency for 
Research on Cancer (IARC) ``Monographs on the Evaluation of 
Carcinogenic Risks to Humans'' (2006).
---------------------------------------------------------------------------

    A.6.2.1 For the purpose of classification for carcinogenicity, 
substances are allocated to one of two categories based on strength 
of evidence and additional weight of evidence considerations. In 
certain instances, route-specific classification may be warranted.

             Figure A.6.1--Hazard Categories for Carcinogens
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Known or presumed human carcinogens. The classification of a
 substance as a Category 1 carcinogen is done on the basis of
 epidemiological and/or animal data. This classification is further
 distinguished on the basis of whether the evidence for classification
 is largely from human data (Category 1A) or from animal data (Category
 1B):
    Category 1A: Known to have carcinogenic potential for humans.
     Classification in this category is largely based on human evidence.
    Category 1B: Presumed to have carcinogenic potential for humans.
     Classification in this category is largely based on animal
     evidence. The classification of a substance in Category 1A and 1B
     is based on strength of evidence together with weight of evidence
     considerations (See paragraph A.6.2.5). 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); or
        --animal experiments for which there is sufficient evidence to
         demonstrate animal carcinogenicity (presumed human carcinogen).
    In addition, on a case by case basis, scientific judgment 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.

[[Page 9746]]

 
CATEGORY 2: Suspected human carcinogens. The classification 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 1A or B. This classification is
 based on strength of evidence together with weight of evidence
 considerations (See paragraph A.6.2.5). Such evidence may be from
 either limited evidence of carcinogenicity in human studies or from
 limited evidence of carcinogenicity in animal studies.
Other considerations: Where the weight of evidence for the
 carcinogenicity of a substance does not meet the above criteria, any
 positive study conducted in accordance with established scientific
 principles, and which reports statistically significant findings
 regarding the carcinogenic potential of the substance, must be noted on
 the safety data sheet.
------------------------------------------------------------------------

    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 
in the evaluation, followed by the applicable bridging principles, 
and lastly, cut-off values/concentration limit or additivity. 
However, this approach is not used for Carcinogenicity. These 
criteria for Carcinogenicity consider the cut-off values/
concentration limits as the primary tier and allow the 
classification to be modified only on a case-by-case evaluation 
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------

    A.6.3.1 The mixture shall be classified as a carcinogen when at 
least one ingredient has been classified as a Category 1 or Category 
2 carcinogen and is present at or above the appropriate cut-off 
value/concentration limit as shown in Table A.6.1.

  Table A.6.1--Cut-Off Values/Concentration Limits of Ingredients of a
  Mixture Classified as Carcinogen That Would Trigger Classification of
                               the Mixture
------------------------------------------------------------------------
                                        Category 1         Category 2
     Ingredient classified as:          carcinogen         carcinogen
------------------------------------------------------------------------
Category 1 carcinogen.............            >=0.1%   .................
Category 2 carcinogen.............  .................   >=0.1% (note 1)
------------------------------------------------------------------------
Note: If a Category 2 carcinogen ingredient is present in the mixture at
  a concentration between 0.1% and 1%, information is required on the
  SDS for a product. However, a label warning is optional. If a Category
  2 carcinogen ingredient is present in the mixture at a concentration
  of =1%, both an SDS and a label is required and the
  information must be included on each.

[[Page 9747]]

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 this section 
subpart, 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 behaviour, 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. Substance
 shall be classified in Category 1 for reproductive toxicity when they
 are known to have produced an adverse effect on sexual function and
 fertility or on development in humans or when 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. The classification of a
 substance is 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 classification
     of a substance in this category is largely based on evidence from
     humans.
    Category 1B: Presumed human reproductive toxicant. The
     classification of a substance in this category is largely based on
     evidence from experimental animals. Data from animal studies shall
     provide sufficient 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. Substances shall be
 classified in Category 2 for reproductive toxicity when 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 would 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 shall be classified in a separate single
 category. Chemicals that are absorbed by women and have been shown to
 interfere with lactation or that may be present (including metabolites)
 in breast milk in amounts sufficient to cause concern for the health of
 a breastfed child, shall be classified to indicate this property.
 Classification for effects via lactation shall be assigned on the basis
 of:
    (a) Absorption, metabolism, distribution and excretion studies that
     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.
------------------------------------------------------------------------

[[Page 9748]]

A.7.2.2 Basis of Classification

    A.7.2.2.1 Classification is made on the basis of the criteria, 
outlined above, an assessment of the total weight of evidence, and 
the use of expert judgment. Classification as a reproductive 
toxicant is intended to be used for substances which have an 
intrinsic, specific property to produce an adverse effect on 
reproduction and substances should not be so classified if such an 
effect is produced solely as a non-specific secondary consequence of 
other toxic effects.
    A.7.2.2.2 In the evaluation of toxic effects on the developing 
offspring, it is important to consider the possible influence of 
maternal toxicity.
    A.7.2.2.3 For human evidence to provide the primary basis for a 
Category 1A classification there must be reliable evidence of an 
adverse effect on reproduction in humans. Evidence used for 
classification shall be from well conducted epidemiological studies, 
if available, which include the use of appropriate controls, 
balanced assessment, and due consideration of bias or confounding 
factors. Less rigorous data from studies in humans may be sufficient 
for a Category 1A classification if supplemented with adequate data 
from studies in experimental animals, but classification in Category 
1B may also be considered.

A.7.2.3 Weight of Evidence

    A.7.2.3.1 Classification as a reproductive toxicant is made on 
the basis of an assessment of the total weight of evidence using 
expert judgment. This means that all available information that 
bears on the determination of reproductive toxicity is considered 
together. Included is information such as epidemiological studies 
and case reports in humans and specific reproduction studies along 
with sub-chronic, chronic and special study results in animals that 
provide relevant information regarding toxicity to reproductive and 
related endocrine organs. Evaluation of substances chemically 
related to the material under study may also be included, 
particularly when information on the material is scarce. The weight 
given to the available evidence will be influenced by factors such 
as the quality of the studies, consistency of results, nature and 
severity of effects, level of statistical significance for 
intergroup differences, number of endpoints affected, relevance of 
route of administration to humans and freedom from bias. Both 
positive and negative results are considered together in a weight of 
evidence determination. However, a single, positive study performed 
according to good scientific principles and with statistically or 
biologically significant positive results may justify classification 
(See also A.7.2.2.3).
    A.7.2.3.2 Toxicokinetic studies in animals and humans, site of 
action and mechanism or mode of action study results may provide 
relevant information, which could reduce or increase concerns about 
the hazard to human health. If it is conclusively demonstrated that 
the clearly identified mechanism or mode of action has no relevance 
for humans or when the toxicokinetic differences are so marked that 
it is certain that the hazardous property will not be expressed in 
humans then a chemical which produces an adverse effect on 
reproduction in experimental animals should not be classified.
    A.7.2.3.3 In some reproductive toxicity studies in experimental 
animals the only effects recorded may be considered of low or 
minimal toxicological significance and classification may not 
necessarily be the outcome. These effects include, for example, 
small changes in semen parameters or in the incidence of spontaneous 
defects in the fetus, small changes in the proportions of common 
fetal variants such as are observed in skeletal examinations, or in 
fetal weights, or small differences in postnatal developmental 
assessments.
    A.7.2.3.4 Data from animal studies shall provide sufficient 
evidence of specific reproductive toxicity in the absence of other 
systemic toxic effects. However, if developmental toxicity occurs 
together with other toxic effects in the dam (mother), the potential 
influence of the generalized adverse effects should be assessed to 
the extent possible. The preferred approach is to consider adverse 
effects in the embryo/fetus first, and then evaluate maternal 
toxicity, along with any other factors which are likely to have 
influenced these effects, as part of the weight of evidence. In 
general, developmental effects that are observed at maternally toxic 
doses should not be automatically discounted. Discounting 
developmental effects that are observed at maternally toxic doses 
can only be done on a case-by-case basis when a causal relationship 
is established or refuted.
    A.7.2.3.5 If appropriate information is available it is 
important to try to determine whether developmental toxicity is due 
to a specific maternally mediated mechanism or to a non-specific 
secondary mechanism, like maternal stress and the disruption of 
homeostasis. Generally, the presence of maternal toxicity should not 
be used to negate findings of embryo/fetal effects, unless it can be 
clearly demonstrated that the effects are secondary non-specific 
effects. This is especially the case when the effects in the 
offspring are significant, e.g., irreversible effects such as 
structural malformations. In some situations it is reasonable to 
assume that reproductive toxicity is due to a secondary consequence 
of maternal toxicity and discount the effects, for example if the 
chemical is so toxic that dams fail to thrive and there is severe 
inanition; they are incapable of nursing pups; or they are prostrate 
or dying.

A.7.2.4 Maternal Toxicity

    A.7.2.4.1 Development of the offspring throughout gestation and 
during the early postnatal stages can be influenced by toxic effects 
in the mother either through non-specific mechanisms related to 
stress and the disruption of maternal homeostasis, or by specific 
maternally-mediated mechanisms. So, in the interpretation of the 
developmental outcome to decide classification for developmental 
effects it is important to consider the possible influence of 
maternal toxicity. This is a complex issue because of uncertainties 
surrounding the relationship between maternal toxicity and 
developmental outcome. Expert judgment and a weight of evidence 
approach, using all available studies, shall be used to determine 
the degree of influence to be attributed to maternal toxicity when 
interpreting the criteria for classification for developmental 
effects. The adverse effects in the embryo/fetus shall be first 
considered, and then maternal toxicity, along with any other factors 
which are likely to have influenced these effects, as weight of 
evidence, to help reach a conclusion about classification.
    A.7.2.4.2 Based on pragmatic observation, it is believed that 
maternal toxicity may, depending on severity, influence development 
via non-specific secondary mechanisms, producing effects such as 
depressed fetal weight, retarded ossification, and possibly 
resorptions and certain malformations in some strains of certain 
species. However, the limited numbers of studies which have 
investigated the relationship between developmental effects and 
general maternal toxicity have failed to demonstrate a consistent, 
reproducible relationship across species. Developmental effects 
which occur even in the presence of maternal toxicity are considered 
to be evidence of developmental toxicity, unless it can be 
unequivocally demonstrated on a case by case basis that the 
developmental effects are secondary to maternal toxicity. Moreover, 
classification shall be considered where there is a significant 
toxic effect in the offspring, e.g., irreversible effects such as 
structural malformations, embryo/fetal lethality, or significant 
post-natal functional deficiencies.
    A.7.2.4.3 Classification shall not automatically be discounted 
for chemicals that produce developmental toxicity only in 
association with maternal toxicity, even if a specific maternally-
mediated mechanism has been demonstrated. In such a case, 
classification in Category 2 may be considered more appropriate than 
Category 1. However, when a chemical is so toxic that maternal death 
or severe inanition results, or the dams (mothers) are prostrate and 
incapable of nursing the pups, it is reasonable to assume that 
developmental toxicity is produced solely as a secondary consequence 
of maternal toxicity and discount the developmental effects. 
Classification is not necessarily the outcome in the case of minor 
developmental changes, e.g., a small reduction in fetal/pup body 
weight or retardation of ossification when seen in association with 
maternal toxicity.
    A.7.2.4.4 Some of the endpoints used to assess maternal toxicity 
are provided below. Data on these endpoints, if available, shall be 
evaluated in light of their statistical or biological significance 
and dose-response relationship.
    (a) Maternal mortality: An increased incidence of mortality 
among the treated dams over the controls shall be considered 
evidence of maternal toxicity if the increase occurs in a dose-
related manner and can be attributed to the systemic toxicity of the 
test material. Maternal mortality greater than 10% is considered 
excessive and the data for that dose level shall not normally be 
considered to need further evaluation.
    (b) Mating index (Number of animals with seminal plugs or sperm/
Number of mated x 100).

[[Page 9749]]

    (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 9750]]

     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:                     Category 1      Category 2    Additional category
                                                              reproductive    reproductive    for effects on or
                                                                toxicant        toxicant        via lactation
----------------------------------------------------------------------------------------------------------------
Category 1 reproductive toxicant...........................          >=0.1%
Category 2 reproductive toxicant...........................  ..............          >=0.1%
Additional category for effects on or via lactation........  ..............  ..............               >=0.1%
----------------------------------------------------------------------------------------------------------------

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.7.3.3.1 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: Substances are classified
 in Category 1 for STOT-SE 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.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: Substances are
 classified in Category 2 for STOT-SE 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.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 A.8.2.1.6).
CATEGORY 3: Transient target organ effects: There are target organ
 effects for which a substance does 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 are classified specifically for these effects as
 discussed in A.8.2.2.
------------------------------------------------------------------------
Note: The primary target organ/system shall be identified where
  possible, and where this is not possible, the substance shall be
  identified as a general toxicant. The data shall be 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.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.

[[Page 9751]]

    A.8.2.1.4 Weight of evidence of all available data, including 
human incidents, epidemiology, and studies conducted in experimental 
animals is used to substantiate specific target organ toxic effects 
that merit classification.
    A.8.2.1.5 The information required to evaluate specific target 
organ toxicity comes either from single exposure in humans (e.g., 
exposure at home, in the workplace or environmentally), or from 
studies conducted in experimental animals. The standard animal 
studies in rats or mice that provide this information are acute 
toxicity studies which can include clinical observations and 
detailed macroscopic and microscopic examination to enable the toxic 
effects on target tissues/organs to be identified. Results of acute 
toxicity studies conducted in other species may also provide 
relevant information.
    A.8.2.1.6 In exceptional cases, based on expert judgment, it may 
be appropriate to place certain substances with human evidence of 
target organ toxicity in Category 2: (a) When the weight of human 
evidence is not sufficiently convincing to warrant Category 1 
classification, and/or (b) based on the nature and severity of 
effects. Dose/concentration levels in humans shall not be considered 
in the classification and any available evidence from animal studies 
shall be consistent with the Category 2 classification. In other 
words, if there are also animal data available on the substance that 
warrant Category 1 classification, the chemical shall be classified 
as Category 1.
    A.8.2.1.7 Effects considered to support classification for 
Category 1 and 2.
    A.8.2.1.7.1 Classification is supported by evidence associating 
single exposure to the substance with a consistent and identifiable 
toxic effect.
    A.8.2.1.7.2 Evidence from human experience/incidents is usually 
restricted to reports of adverse health consequences, often with 
uncertainty about exposure conditions, and may not provide the 
scientific detail that can be obtained from well-conducted studies 
in experimental animals.
    A.8.2.1.7.3 Evidence from appropriate studies in experimental 
animals can furnish much more detail, in the form of clinical 
observations, and macroscopic and microscopic pathological 
examination and this can often reveal hazards that may not be life-
threatening but could indicate functional impairment. Consequently, 
all available evidence, and relevance to human health, must be taken 
into consideration in the classification process. Relevant toxic 
effects in humans and/or animals include, but are not limited to:
    (a) Morbidity resulting from single exposure;
    (b) Significant functional changes, more than transient in 
nature, in the respiratory system, central or peripheral nervous 
systems, other organs or other organ systems, including signs of 
central nervous system depression and effects on special senses 
(e.g., sight, hearing and sense of smell);
    (c) Any consistent and significant adverse change in clinical 
biochemistry, hematology, or urinalysis parameters;
    (d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;
    (e) Multi-focal or diffuse necrosis, fibrosis or granuloma 
formation in vital organs with regenerative capacity;
    (f) Morphological changes that are potentially reversible but 
provide clear evidence of marked organ dysfunction; and,
    (g) Evidence of appreciable cell death (including cell 
degeneration and reduced cell number) in vital organs incapable of 
regeneration.
    A.8.2.1.8 Effects considered not to support classification for 
Category 1 and 2.
    Effects may be seen in humans and/or animals that do not justify 
classification. Such effects include, but are not limited to:
    (a) Clinical observations or small changes in bodyweight gain, 
food consumption or water intake that may have some toxicological 
importance but that do not, by themselves, indicate ``significant'' 
toxicity;
    (b) Small changes in clinical biochemistry, hematology or 
urinalysis parameters and/or transient effects, when such changes or 
effects are of doubtful or of minimal toxicological importance;
    (c) Changes in organ weights with no evidence of organ 
dysfunction;
    (d) Adaptive responses that are not considered toxicologically 
relevant; and,
    (e) Substance-induced species-specific mechanisms of toxicity, 
i.e., demonstrated with reasonable certainty to be not relevant for 
human health, shall not justify classification.
    A.8.2.1.9 Guidance values to assist with classification based on 
the results obtained from studies conducted in experimental animals 
for Category 1 and 2.
    A.8.2.1.9.1 In order to help reach a decision about whether a 
substance shall be classified or not, and to what degree it shall be 
classified (Category 1 vs. Category 2), dose/concentration 
``guidance values'' are provided for consideration of the dose/
concentration which has been shown to produce significant health 
effects. The principal argument for proposing such guidance values 
is that all chemicals are potentially toxic and there has to be a 
reasonable dose/concentration above which a degree of toxic effect 
is acknowledged.
    A.8.2.1.9.2 Thus, in animal studies, when significant toxic 
effects are observed that indicate classification, consideration of 
the dose/concentration at which these effects were seen, in relation 
to the suggested guidance values, provides useful information to 
help assess the need to classify (since the toxic effects are a 
consequence of the hazardous property(ies) and also the dose/
concentration).
    A.8.2.1.9.3 The guidance value (C) ranges for single-dose 
exposure which has produced a significant non-lethal toxic effect 
are those applicable to acute toxicity testing, as indicated in 
Table A.8.1.

                          Table A.8.1--Guidance Value Ranges for Single-Dose Exposures
----------------------------------------------------------------------------------------------------------------
                                                                      Guidance value ranges for:
----------------------------------------------------------------------------------------------------------------
        Route of exposure                Units            Category 1          Category 2          Category 3
----------------------------------------------------------------------------------------------------------------
Oral (rat)......................  mg/kg body weight.  C <= 300..........  2,000 >= C > 300..  Guidance values do
                                                                                               not apply.
Dermal (rat or rabbit)..........  mg/kg body weight.  C <= 1,000........  2,000 >= C > 1,000
Inhalation (rat) gas............  ppmV/4h...........  C <= 2,500........  20,000 >= C >
                                                                           2,500.
Inhalation (rat) vapor..........  mg/1/4h...........  C <= 10...........  20 >= C > 10......
Inhalation (rat) dust/mist/fume.  mg/l/4h...........  C <= 1.0..........  5.0 >= C > 1.0....
----------------------------------------------------------------------------------------------------------------

    A.8.2.1.9.4 The guidance values and ranges mentioned in Table 
A.8.1 are intended only for guidance purposes, i.e., to be used as 
part of the weight of evidence approach, and to assist with 
decisions about classification. They are not intended as strict 
demarcation values. Guidance values are not provided for Category 3 
since this classification is primarily based on human data; animal 
data may be included in the weight of evidence evaluation.
    A.8.2.1.9.5 Thus, it is feasible that a specific profile of 
toxicity occurs at a dose/concentration below the guidance value, 
e.g., <2,000 mg/kg body weight by the oral route, however the nature 
of the effect may result in the decision not to classify. 
Conversely, a specific profile of toxicity may be seen in animal 
studies occurring at above a guidance value, e.g., >=2,000 mg/kg 
body weight by the oral route, and in addition there is 
supplementary information from other sources, e.g., other single 
dose studies, or human case experience, which supports a conclusion 
that, in view of the weight of evidence, classification is the 
prudent action to take.
    A.8.2.1.10 Other considerations.
    A.8.2.1.10.1 When a substance is characterized only by use of 
animal data the classification process includes reference to dose/
concentration guidance values as one of

[[Page 9752]]

the elements that contribute to the weight of evidence approach.
    A.8.2.1.10.2 When well-substantiated human data are available 
showing a specific target organ toxic effect that can be reliably 
attributed to single exposure to a substance, the substance shall be 
classified. Positive human data, regardless of probable dose, 
predominates over animal data. Thus, if a substance is unclassified 
because specific target organ toxicity observed was considered not 
relevant or significant to humans, if subsequent human incident data 
become available showing a specific target organ toxic effect, the 
substance shall be classified.
    A.8.2.1.10.3 A substance that has not been tested for specific 
target organ toxicity shall, where appropriate, be classified on the 
basis of data from a scientifically validated structure activity 
relationship and expert judgment-based extrapolation from a 
structural analogue that has previously been classified together 
with substantial support from consideration of other important 
factors such as formation of common significant metabolites.

A.8.2.2 Substances of Category 3

    A.8.2.2.1 Criteria for respiratory tract irritation.
    The criteria for classifying substances as Category 3 for 
respiratory tract irritation are:
    (a) Respiratory irritant effects (characterized by localized 
redness, edema, pruritis and/or pain) that impair function with 
symptoms such as cough, pain, choking, and breathing difficulties 
are included. It is recognized that this evaluation is based 
primarily on human data;
    (b) Subjective human observations supported by objective 
measurements of clear respiratory tract irritation (RTI) (e.g., 
electrophysiological responses, biomarkers of inflammation in nasal 
or bronchoalveolar lavage fluids);
    (c) The symptoms observed in humans shall also be typical of 
those that would be produced in the exposed population rather than 
being an isolated idiosyncratic reaction or response triggered only 
in individuals with hypersensitive airways. Ambiguous reports simply 
of ``irritation'' should be excluded as this term is commonly used 
to describe a wide range of sensations including those such as 
smell, unpleasant taste, a tickling sensation, and dryness, which 
are outside the scope of classification for respiratory tract 
irritation;
    (d) There are currently no scientifically validated animal tests 
that deal specifically with RTI; however, useful information may be 
obtained from the single and repeated inhalation toxicity tests. For 
example, animal studies may provide useful information in terms of 
clinical signs of toxicity (dyspnoea, rhinitis etc.) and 
histopathology (e.g., hyperemia, edema, minimal inflammation, 
thickened mucous layer) which are reversible and may be reflective 
of the characteristic clinical symptoms described above. Such animal 
studies can be used as part of weight of evidence evaluation; and,
    (e) This special classification will occur only when more severe 
organ effects including the respiratory system are not observed as 
those effects would require a higher classification.
    A.8.2.2.2 Criteria for narcotic effects.
    The criteria for classifying substances in Category 3 for 
narcotic effects are:
    (a) Central nervous system depression including narcotic effects 
in humans such as drowsiness, narcosis, reduced alertness, loss of 
reflexes, lack of coordination, and vertigo are included. These 
effects can also be manifested as severe headache or nausea, and can 
lead to reduced judgment, dizziness, irritability, fatigue, impaired 
memory function, deficits in perception and coordination, reaction 
time, or sleepiness; and,
    (b) Narcotic effects observed in animal studies may include 
lethargy, lack of coordination righting reflex, narcosis, and 
ataxia. If these effects are not transient in nature, then they 
shall be considered for classification as Category 1 or 2.

A.8.3 Classification Criteria for Mixtures

    A.8.3.1 Mixtures are classified using the same criteria as for 
substances, or alternatively as described below. As with substances, 
mixtures may be classified for specific target organ toxicity 
following single exposure, repeated exposure, or both.

A.8.3.2 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    When reliable and good quality evidence from human experience or 
appropriate studies in experimental animals, as described in the 
criteria for substances, is available for the mixture, then the 
mixture shall be classified by weight of evidence evaluation of this 
data. Care shall be exercised in evaluating data on mixtures, that 
the dose, duration, observation or analysis, do not render the 
results inconclusive.

A.8.3.3 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.8.3.3.1 Where the mixture itself has not been tested to 
determine its specific target organ toxicity, but there are 
sufficient data on both the individual ingredients and similar 
tested mixtures to adequately characterize the hazards of the 
mixture, these data shall be used in accordance with the following 
bridging principles as found in paragraph A.0.5 of this appendix: 
Dilution, Batching, Concentration of mixtures, Interpolation within 
one hazard category, Substantially similar mixtures, or Aerosols.

A.8.3.4 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.8.3.4.1 Where there is no reliable evidence or test data for 
the specific mixture itself, and the bridging principles cannot be 
used to enable classification, then classification of the mixture is 
based on the classification of the ingredient substances. In this 
case, the mixture shall be classified as a specific target organ 
toxicant (specific organ specified), following single exposure, 
repeated exposure, or both when at least one ingredient has been 
classified as a Category 1 or Category 2 specific target organ 
toxicant and is present at or above the appropriate cut-off value/
concentration limit specified in Table A.8.2 for Categories 1 and 2, 
respectively.

  Table A.8.2--Cut-Off Values/Concentration Limits of Ingredients of a
    Mixture Classified as a Specific Target Organ Toxicant That Would
        Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
                                           Cut-off values/concentration
                                                 limits triggering
                                            classification of a mixture
        Ingredient classified as:                       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

[[Page 9753]]

effects are to be evaluated separately in accordance with the 
criteria given in A.8.2.2. When conducting classifications for these 
hazards, the contribution of each ingredient should be considered 
additive, unless there is evidence that the effects are not 
additive.
    A.8.3.4.6 In cases where the additivity approach is used for 
Category 3 ingredients, the ``relevant ingredients'' of a mixture 
are those which are present in concentrations >=1% (w/w for solids, 
liquids, dusts, mists, and vapours and v/v for gases), unless there 
is a reason to suspect that an ingredient present at a concentration 
<1% is still relevant when classifying the mixture for respiratory 
tract irritation or narcotic effects.

A.9 Specific Target Organ Toxicity Repeated or Prolonged Exposure

A.9.1 Definitions and General Considerations

    A.9.1.1 Specific target organ toxicity--repeated exposure (STOT-
RE) refers to specific toxic effects on target organs occurring 
after repeated exposure to a substance or mixture. All significant 
health effects that can impair function, both reversible and 
irreversible, immediate and/or delayed and not specifically 
addressed in A.1 to A.7 and A.10 of this appendix are included. 
Specific target organ toxicity following a single-event exposure is 
classified in accordance with SPECIFIC TARGET ORGAN TOXICITY-SINGLE 
EXPOSURE (A.8 of this appendix) and is therefore not included here.
    A.9.1.2 Classification identifies the substance or mixture as 
being a specific target organ toxicant and, as such, it may present 
a potential for adverse health effects in people who are exposed to 
it.
    A.9.1.3 These adverse health effects produced by repeated 
exposure include consistent and identifiable toxic effects in 
humans, or, in experimental animals, toxicologically significant 
changes which have affected the function or morphology of a tissue/
organ, or have produced serious changes to the biochemistry or 
hematology of the organism and these changes are relevant for human 
health. Human data will be the primary source of evidence for this 
hazard class.
    A.9.1.4 Assessment shall take into consideration not only 
significant changes in a single organ or biological system but also 
generalized changes of a less severe nature involving several 
organs.
    A.9.1.5 Specific target organ toxicity can occur by any route 
that is relevant for humans, e.g., principally oral, dermal or 
inhalation.

A.9.2 Classification Criteria for Substances

    A.9.2.1 Substances shall be classified as STOT-RE by expert 
judgment on the basis of the weight of all evidence available, 
including the use of recommended guidance values which take into 
account the duration of exposure and the dose/concentration which 
produced the effect(s), (See A.9.2.9). Substances shall be placed in 
one of two categories, depending upon the nature and severity of the 
effect(s) observed, in accordance with Figure A.9.1.

   Figure A.9.1--Hazard Categories for Specific Target Organ Toxicity
                       Following Repeated Exposure
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Substances that have produced significant toxicity in
 humans, or that, on the basis of evidence from studies in experimental
 animals can be presumed to have the potential to produce significant
 toxicity in humans following repeated or prolonged exposure. Substances
 are classified in Category 1 for specific target organ toxicity
 (repeated exposure) on the basis of:
    (a) Reliable and good quality evidence from human cases or
     epidemiological studies; or,
    (b) observations from appropriate studies in experimental animals in
     which significant and/or severe toxic effects, of relevance to
     human health, were produced at generally low exposure
     concentrations. Guidance dose/concentration values are provided
     below (See A.9.2.9) to be used as part of weight-of-evidence
     evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in
 experimental animals can be presumed to have the potential to be
 harmful to human health following repeated or prolonged exposure.
 Substances are classified in Category 2 for specific target organ
 toxicity (repeated exposure) on the basis of observations from
 appropriate studies in experimental animals in which significant toxic
 effects, of relevance to human health, were produced at generally
 moderate exposure concentrations. Guidance dose/concentration values
 are provided below (See A.9.2.9) in order to help in classification. In
 exceptional cases human evidence can also be used to place a substance
 in Category 2 (See A.9.2.6).
------------------------------------------------------------------------
Note: The primary target organ/system shall be identified where
  possible, or the substance shall be identified as a general toxicant.
  The data shall be carefully evaluated and, where possible, shall not
  include secondary effects (e.g., a hepatotoxicant can produce
  secondary effects in the nervous or gastro-intestinal systems).

    A.9.2.2 The relevant route of exposure by which the classified 
substance produces damage shall be identified.
    A.9.2.3 Classification is determined by expert judgment, on the 
basis of the weight of all evidence available including the guidance 
presented below.
    A.9.2.4 Weight of evidence of all data, including human 
incidents, epidemiology, and studies conducted in experimental 
animals, is used to substantiate specific target organ toxic effects 
that merit classification.
    A.9.2.5 The information required to evaluate specific target 
organ toxicity comes either from repeated exposure in humans, e.g., 
exposure at home, in the workplace or environmentally, or from 
studies conducted in experimental animals. The standard animal 
studies in rats or mice that provide this information are 28 day, 90 
day or lifetime studies (up to 2 years) that include hematological, 
clinico-chemical and detailed macroscopic and microscopic 
examination to enable the toxic effects on target tissues/organs to 
be identified. Data from repeat dose studies performed in other 
species may also be used. Other long-term exposure studies, e.g., 
for carcinogenicity, neurotoxicity or reproductive toxicity, may 
also provide evidence of specific target organ toxicity that could 
be used in the assessment of classification.
    A.9.2.6 In exceptional cases, based on expert judgment, it may 
be appropriate to place certain substances with human evidence of 
specific target organ toxicity in Category 2: (a) When the weight of 
human evidence is not sufficiently convincing to warrant Category 1 
classification, and/or (b) based on the nature and severity of 
effects. Dose/concentration levels in humans shall not be considered 
in the classification and any available evidence from animal studies 
shall be consistent with the Category 2 classification. In other 
words, if there are also animal data available on the substance that 
warrant Category 1 classification, the substance shall be classified 
as Category 1.

A.9.2.7 Effects Considered To Support Classification

    A.9.2.7.1 Classification is supported by reliable evidence 
associating repeated exposure to the substance with a consistent and 
identifiable toxic effect.
    A.9.2.7.2 Evidence from human experience/incidents is usually 
restricted to reports of adverse health consequences, often with 
uncertainty about exposure conditions, and may not provide the 
scientific detail that can be obtained from well-conducted studies 
in experimental animals.
    A.9.2.7.3 Evidence from appropriate studies in experimental 
animals can furnish much more detail, in the form of clinical 
observations, hematology, clinical chemistry, macroscopic and 
microscopic pathological examination and this can often reveal 
hazards that may not be life-threatening but could indicate 
functional impairment. Consequently, all available evidence, and 
relevance to human health, must be taken into consideration in the 
classification process. Relevant toxic effects in humans and/or 
animals include, but are not limited to:
    (a) Morbidity or death resulting from repeated or long-term 
exposure. Morbidity or death may result from repeated exposure, even 
to relatively low doses/concentrations, due to bioaccumulation of 
the substance or its metabolites, or due to the overwhelming of the 
de-toxification process by repeated exposure;
    (b) Significant functional changes in the central or peripheral 
nervous systems or other organ systems, including signs of

[[Page 9754]]

central nervous system depression and effects on special senses 
(e.g., sight, hearing and sense of smell);
    (c) Any consistent and significant adverse change in clinical 
biochemistry, hematology, or urinalysis parameters;
    (d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;
    (e) Multi-focal or diffuse necrosis, fibrosis or granuloma 
formation in vital organs with regenerative capacity;
    (f) Morphological changes that are potentially reversible but 
provide clear evidence of marked organ dysfunction (e.g., severe 
fatty change in the liver); and,
    (g) Evidence of appreciable cell death (including cell 
degeneration and reduced cell number) in vital organs incapable of 
regeneration.

A.9.2.8 Effects Considered Not To Support Classification

    Effects may be seen in humans and/or animals that do not justify 
classification. Such effects include, but are not limited to:
    (a) Clinical observations or small changes in bodyweight gain, 
food consumption or water intake that may have some toxicological 
importance but that do not, by themselves, indicate ``significant'' 
toxicity;
    (b) Small changes in clinical biochemistry, hematology or 
urinalysis parameters and/or transient effects, when such changes or 
effects are of doubtful or of minimal toxicological importance;
    (c) Changes in organ weights with no evidence of organ 
dysfunction;
    (d) Adaptive responses that are not considered toxicologically 
relevant;
    (e) Substance-induced species-specific mechanisms of toxicity, 
i.e., demonstrated with reasonable certainty to be not relevant for 
human health, shall not justify classification.

A.9.2.9 Guidance Values To Assist With Classification Based on the 
Results Obtained From Studies Conducted in Experimental Animals

    A.9.2.9.1 In studies conducted in experimental animals, reliance 
on observation of effects alone, without reference to the duration 
of experimental exposure and dose/concentration, omits a fundamental 
concept of toxicology, i.e., all substances are potentially toxic, 
and what determines the toxicity is a function of the dose/
concentration and the duration of exposure. In most studies 
conducted in experimental animals the test guidelines use an upper 
limit dose value.
    A.9.2.9.2 In order to help reach a decision about whether a 
substance shall be classified or not, and to what degree it shall be 
classified (Category 1 vs. Category 2), dose/concentration 
``guidance values'' are provided in Table A.9.1 for consideration of 
the dose/concentration which has been shown to produce significant 
health effects. The principal argument for proposing such guidance 
values is that all chemicals are potentially toxic and there has to 
be a reasonable dose/concentration above which a degree of toxic 
effect is acknowledged. Also, repeated-dose studies conducted in 
experimental animals are designed to produce toxicity at the highest 
dose used in order to optimize the test objective and so most 
studies will reveal some toxic effect at least at this highest dose. 
What is therefore to be decided is not only what effects have been 
produced, but also at what dose/concentration they were produced and 
how relevant is that for humans.
    A.9.2.9.3 Thus, in animal studies, when significant toxic 
effects are observed that indicate classification, consideration of 
the duration of experimental exposure and the dose/concentration at 
which these effects were seen, in relation to the suggested guidance 
values, provides useful information to help assess the need to 
classify (since the toxic effects are a consequence of the hazardous 
property(ies) and also the duration of exposure and the dose/
concentration).
    A.9.2.9.4 The decision to classify at all can be influenced by 
reference to the dose/concentration guidance values at or below 
which a significant toxic effect has been observed.
    A.9.2.9.5 The guidance values refer to effects seen in a 
standard 90-day toxicity study conducted in rats. They can be used 
as a basis to extrapolate equivalent guidance values for toxicity 
studies of greater or lesser duration, using dose/exposure time 
extrapolation similar to Haber's rule for inhalation, which states 
essentially that the effective dose is directly proportional to the 
exposure concentration and the duration of exposure. The assessment 
should be done on a case-by-case basis; for example, for a 28-day 
study the guidance values below would be increased by a factor of 
three.
    A.9.2.9.6 Thus for Category 1 classification, significant toxic 
effects observed in a 90-day repeated-dose study conducted in 
experimental animals and seen to occur at or below the (suggested) 
guidance values (C) as indicated in Table A.9.1 would justify 
classification:

   Table A.9.1--Guidance Values To Assist in Category 1 Classification
                     [Applicable to a 90-day study]
------------------------------------------------------------------------
                                                        Guidance values
        Route of exposure                Units              (dose/
                                                        concentration)
------------------------------------------------------------------------
Oral (rat)......................  mg/kg body weight/  C <=10
                                   day.
Dermal (rat or rabbit)..........  mg/kg body weight/  C <=20
                                   day.
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]
------------------------------------------------------------------------
                                                        Guidance value
        Route of exposure                Units           range (dose/
                                                        concentration)
------------------------------------------------------------------------
Oral (rat)......................  mg/kg body weight/  10 =100 mg/kg body weight/day by the oral route, and in addition there 
is supplementary information from other sources, e.g., other long-
term administration studies, or human case experience, which 
supports a conclusion that, in view of the weight of evidence, 
classification is prudent.

A.9.2.10 Other Considerations

    A.9.2.10.1 When a substance is characterized only by use of 
animal data the classification process includes reference to dose/
concentration guidance values as one of the elements that contribute 
to the weight of evidence approach.
    A.9.2.10.2 When well-substantiated human data are available 
showing a specific target organ toxic effect that can be reliably 
attributed to repeated or prolonged exposure to a substance, the 
substance shall be classified. Positive human data, regardless of 
probable dose, predominates over animal data. Thus, if a substance 
is unclassified because no specific target organ toxicity was seen 
at or below the dose/concentration guidance value for animal 
testing, if subsequent human incident data become available showing 
a specific target organ toxic effect, the substance shall be 
classified.
    A.9.2.10.3 A substance that has not been tested for specific 
target organ toxicity may in certain instances, where appropriate, 
be classified on the basis of data from a scientifically validated 
structure activity relationship and expert judgment-based 
extrapolation from a structural analogue that has previously been 
classified together with substantial support from consideration of 
other important factors such as formation of common significant 
metabolites.

A.9.3 Classification Criteria for Mixtures

    A.9.3.1 Mixtures are classified using the same criteria as for 
substances, or alternatively as described below. As with substances, 
mixtures may be classified for specific target organ toxicity 
following single exposure, repeated exposure, or both.

A.9.3.2 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    When reliable and good quality evidence from human experience or 
appropriate studies in experimental animals, as described in the 
criteria for substances, is available for the mixture, then the 
mixture shall be classified by weight of evidence evaluation of 
these data. Care shall be exercised in evaluating data on mixtures, 
that the dose, duration, observation or analysis, do not render the 
results inconclusive.

A.9.3.3 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.9.3.3.1 Where the mixture itself has not been tested to 
determine its specific target organ toxicity, but there are 
sufficient data on both the individual ingredients and similar 
tested mixtures to adequately characterize the hazards of the 
mixture, these data shall be used in accordance with the following 
bridging principles as found in paragraph A.0.5 of this appendix: 
Dilution; Batching; Concentration of mixtures; Interpolation within 
one hazard category; Substantially similar mixtures; and Aerosols.

A.9.3.4 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.9.3.4.1 Where there is no reliable evidence or test data for 
the specific mixture itself, and the bridging principles cannot be 
used to enable classification, then classification of the mixture is 
based on the classification of the ingredient substances. In this 
case, the mixture shall be classified as a specific target organ 
toxicant (specific organ specified), following single exposure, 
repeated exposure, or both when at least one ingredient has been 
classified as a Category 1 or Category 2 specific target organ 
toxicant and is present at or above the appropriate cut-off value/
concentration limit specified in Table A.9.3 for Category 1 and 2 
respectively.

   Table A.9.3--Cut-Off Value/Concentration Limits of Ingredients of a
    Mixture Classified as a Specific Target Organ Toxicant That Would
        Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
                                           Cut-off values/concentration
                                                 limits triggering
                                            classification of a mixture
        Ingredient classified as:                       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 
labelling, 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] TP16FE21.088

[[Page 9756]]

    A.10.1.5.2 Although the definition of aspiration in A.10.1.1 
includes the entry of solids into the respiratory system, 
classification according to (b) in table A.10.1 for Category 1 is 
intended to apply to liquid substances and mixtures only.
    A.10.1.5.3 Classification of aerosol/mist products
    Aerosol and mist products are usually dispensed in containers 
such as self-pressurized containers, trigger and pump sprayers. 
Classification for these products shall be considered if their use 
may form a pool of product in the mouth, which then may be 
aspirated. If the mist or aerosol from a pressurized container is 
fine, a pool may not be formed. On the other hand, if a pressurized 
container dispenses product in a stream, a pool may be formed that 
may then be aspirated. Usually, the mist produced by trigger and 
pump sprayers is coarse and therefore, a pool may be formed that 
then may be aspirated. When the pump mechanism may be removed and 
contents are available to be swallowed then the classification of 
the products should be considered.

A.10.2 Classification Criteria for Substances

             Table A.10.1--Criteria for Aspiration Toxicity
------------------------------------------------------------------------
             Category                             Criteria
------------------------------------------------------------------------
Category 1: Chemicals known to      A substance shall be classified in
 cause human aspiration toxicity     Category 1:
 hazards or to be regarded as if    (a) If reliable and good quality
 they cause human aspiration         human evidence indicates that it
 toxicity hazard.                    causes aspiration toxicity (See
                                     note); or
                                    (b) If it is a hydrocarbon and has a
                                     kinematic viscosity <=20.5 mm2/s,
                                     measured at 40 [deg]C.
------------------------------------------------------------------------
Note: Examples of substances included in Category 1 are certain
  hydrocarbons, turpentine and pine oil.

A.10.3 Classification Criteria for Mixtures

A.10.3.1 Classification When Data Are Available for the Complete 
Mixture

    A mixture shall be classified in Category 1 based on reliable 
and good quality human evidence.

A.10.3.2 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.10.3.2.1 Where the mixture itself has not been tested to 
determine its aspiration toxicity, but there are sufficient data on 
both the individual ingredients and similar tested mixtures to 
adequately characterize the hazard of the mixture, these data shall 
be used in accordance with the following bridging principles as 
found in paragraph A.0.5 of this appendix: Dilution; Batching; 
Concentration of mixtures; Interpolation within one hazard category; 
and Substantially similar mixtures. For application of the dilution 
bridging principle, the concentration of aspiration toxicants shall 
not be less than 10%.

A.10.3.3 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.10.3.3.1 The ``relevant ingredients'' of a mixture are those 
which are present in concentrations >=1%.
    A.10.3.3.2 Category 1
    A.10.3.3.2.1 A mixture is classified as Category 1 when the sum 
of the concentrations of Category 1 ingredients is >=10%, and the 
mixture has a kinematic viscosity of <=20.5 mm2/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 mm2/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 the 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

[[Page 9757]]

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) or an oxidizing solid (See B.14) is determined by Test 
Series 8 tests.
    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. 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.10/30/Rev.6 (UN Recommendations 
on the Transport of Dangerous Goods, Manual of Tests and Criteria) 
(incorporated by reference; see Sec.  1910.6) UN ST/SG/AC.10/30/
Rev.6 (UN Recommendations on the Transport of Dangerous Goods, 
Manual of Tests and Criteria) (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:

[[Page 9758]]

[GRAPHIC] [TIFF OMITTED] TP16FE21.078

B.2.3 Additional Classification Considerations

    B.2.3.1 Flammability shall be determined by tests or by 
calculation in accordance with ISO 10156 (Gases and Gas Mixtures--
Determination of Fire Potential and Oxidizing Ability for the 
Selection of Cylinder Valve Outlets; 1996, first edition or 2010, 
third edition) (incorporated by reference; see Sec.  1910.6) and, if 
using fundamental burning velocity for Category 1B, use ISO 817:2014 
(third edition) (Refrigerants--Designation and safety 
classification, Annex C: Method of test for burning velocity 
measurement of flammable gases) (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, edition 1.0 (2010-
01) (Explosive atmospheres--Part 20-1: Material characteristics for 
gas and vapor classification--Test methods and data) (incorporated 
by reference; see Sec.  1910.6) or DIN 51794 (2003) (Determining the 
ignition temperature of petroleum products) (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.10/30/Rev.6 
(UN Recommendations on the Transport of Dangerous Goods, Manual of 
Tests and Criteria) (incorporated by reference; see Sec.  1910.6)]. 
If the calculations performed in accordance with ISO 10156 (Gases 
and Gas Mixtures--Determination of Fire Potential and Oxidizing 
Ability for the Selection of Cylinder Valve Outlets; 1996, first 
edition or 2010, third edition) (incorporated by reference; see 
Sec.  1910.6) show that a gas mixture is not flammable, no 
additional testing is required for determining chemical instability 
for classification purposes.

B.3 Aerosols

B.3.1 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.3.2 Classification Criteria

    B.3.2.1 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, 
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.
    Note 1: Flammable components do not include pyrophoric, self-
heating or water-reactive chemicals.

[[Page 9759]]

    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.
    B.3.2.2 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/m3; or
                           (ii) Deflagration density is <=300 g/m3
                           (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........................  The chemical does not meet the criteria for
                            Categories 1 and 2. The chemical contains
                            <=1% flammable components (by mass) and has
                            a heat of combustion <20 kJ/g.
------------------------------------------------------------------------

    Note: 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.3.3 Additional Classification Considerations

    B.3.3.1 To classify an aerosol, data on its flammable 
components, on its chemical heat of combustion and, if applicable, 
the results of the aerosol foam flammability test (for foam 
aerosols) and of the ignition distance test and enclosed space test 
(for spray aerosols) are necessary.
    B.3.3.2 The chemical heat of combustion ([Delta]Hc), in 
kilojoules per gram (kJ/g), is the product of the theoretical heat 
of combustion ([Delta]Hcomb), and a combustion efficiency, usually 
less than 1.0 (a typical combustion efficiency is 0.95 or 95%).
    For a composite aerosol formulation, the chemical heat of 
combustion is the summation of the weighted heats of combustion for 
the individual components, as follows:
[GRAPHIC] [TIFF OMITTED] TP16FE21.089

where:

[Delta]Hc = chemical heat of combustion (kJ/g);
wi% = mass fraction of component i in the product;
[Delta]Hc(i) = specific heat of combustion (kJ/g) of component i in 
the product;

    The chemical heats of combustion shall be found in literature, 
calculated or determined by tests (See ASTM D240-02; ISO 13943, 
Sections 86.1 to 86.3; and NFPA 30B (incorporated by reference; See 
Sec.  1910.6)).
    B.3.3.3 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 the of the 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 (Gases and Gas Mixtures--Determination 
of Fire Potential and Oxidizing Ability for the Selection of 
Cylinder Valve Outlets; 1996, first edition or 2010, third edition) 
(incorporated by reference; see Sec.  1910.6) or 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) (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 (Gases and Gas Mixtures--
Determination of Fire Potential and Oxidizing Ability for the 
Selection of Cylinder Valve Outlets; 1996, first edition or 2010, 
third edition) (incorporated by reference; see Sec.  1910.6) and 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) (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.

[[Page 9760]]

    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 under 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).
Liquefied gas................  A gas which when under pressure, is
                                partially liquid at temperatures above -
                                50 [deg]C (-58 [deg]F). A distinction is
                                made between:
                                  (a) High pressure liquefied gas: A gas
                                   with a critical temperature1 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
                                because 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.

B.6.2 Classification Criteria

    A flammable liquid shall be classified in one of four categories 
in accordance with Table B.6.1:

               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), any method specified in 29 CFR 1910.106(a)(14), 
or any other method specified in GHS Revision 7, Chapter 2.6.
    The initial boiling point shall be determined in accordance with 
ASTM D86-07a or ASTM D1078 (incorporated by reference; see Sec.  
1910.6).\9\
---------------------------------------------------------------------------

    \9\ To determine the appropriate flammable liquid storage 
container size and type, the boiling point shall be determined by 
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.
---------------------------------------------------------------------------

B.7 Flammable Solids

B.7.1 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 the UN ST/SG/AC.10 (incorporated by reference; See 
Sec.  1910.6), Part III, sub-section 33.2.1, 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 the 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:

[[Page 9761]]

 
                           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 of this section.

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 the 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 the UN ST/SG/AC.10, Part II, 
section 28 (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 
the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6); or
    (b) For a single organic substance or a homogeneous mixture of 
organic substances, the estimated SADT is greater than 75 [deg]C 
(167 [deg]F) or the exothermic decomposition energy is less than 300 
J/g. The onset temperature and decomposition energy may be estimated 
using a suitable calorimetric technique (See 20.3.3.3 in Part II of 
the 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 the 
UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), in 
accordance with Table B.9.1:

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

[[Page 9762]]

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 the 
UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), in 
accordance with Table B.10.1:

              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 
the 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 m\3\; or
                           (b) A positive result is obtained in a test
                            using a 100 mm cube sample at 120 [deg]C
                            (248 [deg]F) and the unit volume of the
                            chemical is more than 450 liters; or
                           (c) A positive result is obtained in a test
                            using a 100 mm cube sample at 100 [deg]C
                            (212 [deg]F).
------------------------------------------------------------------------

    Note: Classification of solid chemicals shall be based on tests 
performed on the chemical as presented. If, for example, for the 
purposes of supply or transport, the same chemical is to be 
presented in a physical form different from that which was tested 
and which is considered likely to materially alter its performance 
in a classification test, classification must be based on testing of 
the chemical in the new form.
    B.11.2.2 Chemicals with a temperature of spontaneous combustion 
higher than 50[deg]C (122 [deg]F) for a volume of 27 m3 shall not be 
classified as self-heating chemicals.
    B.11.2.3 Chemicals with a spontaneous ignition temperature 
higher than 50 [deg]C (122 [deg]F) for a volume of 450 liters shall 
not be classified in Category 1 of this class.

B.11.3 Additional Classification Considerations

    B.11.3.1 The classification procedure for self-heating chemicals 
need not be applied if the results of a screening test can be 
adequately correlated with the classification test and an 
appropriate safety margin is applied.
    B.11.3.2 Examples of screening tests are:
    (a) The Grewer Oven test (VDI guideline 2263, part 1, 1990, Test 
methods for the Determination of the Safety Characteristics of 
Dusts) with an onset temperature 80 [deg]K above the reference 
temperature for a volume of 1 l;
    (b) The Bulk Powder Screening Test (Gibson, N. Harper, D.J. 
Rogers, R. Evaluation of the fire and explosion risks in drying 
powders, Plant Operations Progress, 4 (3), 181-189, 1985) with an 
onset temperature 60 [deg]K above the reference temperature for a 
volume of 1 l.

B.12 Chemicals Which, in Contact With Water, Emit Flammable Gases

B.12.1 Definition

    Chemicals which, in contact with water, emit flammable gases are 
solid or liquid chemicals which, by interaction with water, are 
liable to become spontaneously flammable or to give off flammable 
gases in dangerous quantities.

B.12.2 Classification Criteria

    B.12.2.1 A chemical which, in contact with water, emits 
flammable gases shall be classified in one of the three categories 
for this class, using test N.5 in Part III, sub-section 33.4.1.4 of 
the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), in 
accordance with Table B.12.1:

[[Page 9763]]

 Table B.12.1--Criteria for Chemicals Which, in Contact With Water, Emit
                             Flammable Gases
------------------------------------------------------------------------
         Category                             Criteria
------------------------------------------------------------------------
1........................  Any chemical which reacts vigorously with
                            water at ambient temperatures and
                            demonstrates generally a tendency for the
                            gas produced to ignite spontaneously, or
                            which reacts readily with water at ambient
                            temperatures such that the rate of evolution
                            of flammable gas is equal to or greater than
                            10 liters per kilogram of chemical over any
                            one minute.
2........................  Any chemical which reacts readily with water
                            at ambient temperatures such that the
                            maximum rate of evolution of flammable gas
                            is equal to or greater than 20 liters per
                            kilogram of chemical per hour, and which
                            does not meet the criteria for Category 1.
3........................  Any chemical which reacts slowly with water
                            at ambient temperatures such that the
                            maximum rate of evolution of flammable gas
                            is greater than 1 liter per kilogram of
                            chemical per hour, and which does not meet
                            the criteria for Categories 1 and 2.
------------------------------------------------------------------------

    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 the 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 the 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 or test O.3 in Part III, sub-section 34.4.3, of the UN ST/SG/
AC.10 (incorporated by reference; See Sec.  1910.6), in accordance 
with Table B.14.1:

               Table B.14.1--Criteria for Oxidizing Solids
------------------------------------------------------------------------
                                                    Criteria using test
        Category         Criteria using test O.1            O.3
------------------------------------------------------------------------
1......................  Any chemical which, in   Any chemical which, in
                          the 4:1 or 1:1 sample-   the 4:1 or 1:1 sample-
                          to-cellulose ratio (by   to-cellulose ratio
                          mass) tested, exhibits   (by mass) tested,
                          a mean burning time      exhibits a mean
                          less than the mean       burning rate greater
                          burning time of a 3:2    than the mean burning
                          mixture, (by mass), of   rate of a 3:1 mixture
                          potassium bromate and    (by mass) of calcium
                          cellulose.               peroxide and
                                                   cellulose.

[[Page 9764]]

 
2......................  Any chemical which, in   Any chemical which, in
                          the 4:1 or 1:1 sample-   the 4:1 or 1:1 sample-
                          to-cellulose ratio (by   to-cellulose ratio
                          mass) tested, exhibits   (by mass) tested,
                          a mean burning time      exhibits a mean
                          equal to or less than    burning rate equal to
                          the mean burning time    or greater than the
                          of a 2:3 mixture (by     mean burning rate of
                          mass) of potassium       a 1:1 mixture (by
                          bromate and cellulose    mass) of calcium
                          and the criteria for     peroxide and
                          Category 1 are not met.  cellulose and the
                                                   criteria for Category
                                                   1 are not met.
3......................  Any chemical which, in   Any chemical which, in
                          the 4:1 or 1:1 sample-   the 4:1 or 1:1 sample-
                          to-cellulose ratio (by   to-cellulose ratio
                          mass) tested, exhibits   (by mass) tested,
                          a mean burning time      exhibits a mean
                          equal to or less than    burning rate equal to
                          the mean burning time    or greater than the
                          of a 3:7 mixture (by     mean burning rate of
                          mass) of potassium       a 1:2 mixture (by
                          bromate and cellulose    mass) of calcium
                          and the criteria for     peroxide and
                          Categories 1 and 2 are   cellulose and the
                          not met.                 criteria for
                                                   Categories 1 and 2
                                                   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 precedence 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] TP16FE21.090

where:

ni = number of peroxygen groups per molecule of organic 
peroxide i;
ci = concentration (mass %) of organic peroxide i;
mi = molecular mass of organic peroxide i.

    B.15.2.2 Organic peroxides shall be classified in one of the 
seven categories of ``Types A to G'' for this class, according to 
the following principles:
    (a) Any organic peroxide which, as packaged, can detonate or 
deflagrate rapidly shall be defined as organic peroxide TYPE A;
    (b) Any organic peroxide possessing explosive properties and 
which, as packaged, neither detonates nor deflagrates rapidly, but 
is liable to undergo a thermal explosion in that package shall be 
defined as organic peroxide TYPE B;
    (c) Any organic peroxide possessing explosive properties when 
the chemical as packaged cannot detonate or deflagrate rapidly or 
undergo a thermal explosion shall be defined as organic peroxide 
TYPE C;
    (d) Any organic peroxide which in laboratory testing meets the 
criteria in (d)(i), (ii), or (iii) shall be defined as organic 
peroxide TYPE D:
    (i) Detonates partially, does not deflagrate rapidly and shows 
no violent effect when heated under confinement; or
    (ii) Does not detonate at all, deflagrates slowly and shows no 
violent effect when heated under confinement; or
    (iii) Does not detonate or deflagrate at all and shows a medium 
effect when heated under confinement;
    (e) Any organic peroxide which, in laboratory testing, neither 
detonates nor deflagrates at all and shows low or no effect when 
heated under confinement shall be defined as organic peroxide TYPE 
E;
    (f) Any organic peroxide which, in laboratory testing, neither 
detonates in the cavitated state nor deflagrates at all and shows 
only a low or no effect when heated under confinement as well as low 
or no explosive power shall be defined as organic peroxide TYPE F;
    (g) Any organic peroxide which, in laboratory testing, neither 
detonates in the cavitated state nor deflagrates at all and shows no 
effect when heated under confinement nor any explosive power, 
provided that it is thermally stable (self-accelerating 
decomposition temperature is 60 [deg]C (140 [deg]F) or higher for a 
50 kg (110 lb) package), and, for liquid mixtures, a diluent having 
a boiling point of not less than 150 [deg]C (302 [deg]F) is used for 
desensitization, shall be defined as organic peroxide TYPE G. If the 
organic peroxide is not thermally stable or a diluent having a 
boiling point less than 150 [deg]C (302 [deg]F) is used for 
desensitization, it shall be defined as organic peroxide TYPE F.

B.15.3 Additional Classification Considerations

    B.15.3.1 For purposes of classification, the properties of 
organic peroxides shall be determined in accordance with test series 
A to H as described in Part II of the 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 the 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.

[[Page 9765]]

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 the 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 aluminium
                            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.

Chapter 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). (As defined in Chapter 2.1 of UN ST/SG/AC.10/30/Rev.6 (UN 
Recommendations on the Transport of Dangerous Goods, Manual of Test 
Criteria) (incorporated by reference; see Sec.  1910.6)).
    \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.10/30/Rev. 6 (UN 
Recommendations on the Transport of Dangerous Goods, Manual of Tests 
and Criteria) (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.17.1.2 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.2.17.2.1 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
    (b) 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.10/30/Rev.6 
(UN Recommendations on the Transport of Dangerous Goods, Manual of 
Tests and Criteria) (incorporated by reference; see Sec.  1910.6) is 
greater than 1200 kg/min; or
    (c) 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.10/30/Rev.6 (UN Recommendations 
on the Transport of Dangerous Goods, Manual of Tests and Criteria) 
(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.10/30/Rev.6 (UN 
Recommendations of the Transport of Dangerous Goods, Manual of Tests 
and Criteria) (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 9766]]

AC.10/30/Rev.6 (UN Recommendations on the Transport of Dangerous 
Goods, Manual of Tests and Criteria) (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.10/30/Rev.6 (UN Recommendations on 
the Transport of Dangerous Goods, Manual of Tests and Criteria) 
(incorporated by reference; see Sec.  1910.6). Testing of solid 
desensitized explosives is addressed in section 33, sub-section 
33.2.3 of UN ST/SG/AC.10/30/Rev.6 (UN Recommendations on the 
Transport of Dangerous Goods, Manual of Tests and Criteria) 
(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.10/30/
Rev. 6 (UN Recommendations on the Transport of Dangerous Goods, 
Manual of Tests and Criteria) (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.
BILLING CODE 4510-26-P

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[GRAPHIC] [TIFF OMITTED] TP16FE21.091

    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

[[Page 9768]]

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 explosive 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. Usually, 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 should 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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BILLING CODE 4510-26-C

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
------------------------------------------------------------------------
              Heading                            Subheading
------------------------------------------------------------------------
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(s) identification.......  (a) Classification of the chemical
                                     in accordance with paragraph (d) of
                                     Sec.   1910.1200, including any
                                     hazards associated with a change in
                                     the chemical's physical form under
                                     normal conditions of use;
                                    (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 identified under normal
                                     conditions of use that result from
                                     a chemical reaction (changing the
                                     chemical structure of the original
                                     substance or mixture);
                                    (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       Except as provided for in paragraph
 ingredients.                        (i) of Sec.   1910.1200 on trade
                                     secrets:
                                    For Substances
                                    (a) Chemical name;
                                    (b) Common name and synonyms;
                                    (c) CAS number and other unique
                                     identifiers;
                                    (d) Impurities and stabilizing
                                     additives (constituents) which are
                                     themselves classified and which
                                     contribute to the classification of
                                     the substance.
                                    For Mixtures
                                    In addition to the information
                                     required for substances:
                                    (a) The chemical name, CAS number or
                                     other unique identifier, and
                                     concentration (exact percentage) or
                                     concentration ranges of all
                                     ingredients which are classified as
                                     health hazards in accordance with
                                     paragraph (d) of Sec.   1910.1200
                                     and
                                     (1) are present above their cut-off/
                                     concentration limits; or
                                     (2) present a health risk below the
                                     cut-off/concentration limits.
                                    (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,
                                     exact percentage (concentration),
                                     or concentration range of
                                     composition has been withheld as a
                                     trade secret is required. When the
                                     concentration or concentration
                                     range is withheld as a trade
                                     secret, the chemical composition
                                     must be provided in accordance with
                                     the prescribed concentration ranges
                                     in Sec.   1910.1200(i)(1)(iv).
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       (a) For all ingredients or
 protection.                         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            (a) Physical state.
 properties.
                                    (b) Color.
                                    (c) Odor.
                                    (d) Melting point/freezing point.
                                    (e) Boiling point (or initial
                                     boiling point or boiling range).
                                    (f) Flammability.

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                                    (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.
                                    (p) Density and/or relative density.
                                    (q) Relative vapor density.
                                    (r) Particle characteristics.
10. Stability and reactivity......  (a) Reactivity;
                                    (b) Chemical stability;
                                    (c) Possibility of hazardous
                                     reactions, including those
                                     associated with foreseeable
                                     emergencies;
                                    (d) Conditions to avoid (e.g.,
                                     static discharge, shock, or
                                     vibration);
                                    (e) Incompatible materials;
                                    (f) Hazardous decomposition
                                     products.
11. Toxicological information.....  Description of the various
                                     toxicological (health) effects and
                                     the available data used to identify
                                     those effects, including:
                                    (a) Information on the likely routes
                                     of exposure (inhalation, ingestion,
                                     skin and eye contact);
                                    (b) Symptoms related to the
                                     physical, chemical and
                                     toxicological characteristics;
                                    (c) Delayed and immediate effects
                                     and also chronic effects from short-
                                      and long-term exposure;
                                    (d) Numerical measures of toxicity
                                     (such as acute toxicity estimates);
                                    (e) Interactive effects; information
                                     on interactions should be included
                                     if relevant and readily available;
                                    (f) Whether the hazardous chemical
                                     is listed in the National
                                     Toxicology Program (NTP) Report on
                                     Carcinogens (latest edition) or has
                                     been found to be a potential
                                     carcinogen in the International
                                     Agency for Research on Cancer
                                     (IARC) Monographs (latest edition),
                                     or by OSHA.
                                    (g) When specific chemical data or
                                     information is not available, the
                                     preparer must indicate if
                                     alternative information is used and
                                     the method used to derive the
                                     information (e.g., where the
                                     preparer is using information from
                                     a class of chemicals rather than
                                     the exact chemical in question and
                                     using SAR to derive the
                                     toxicological information).
12. Ecological information (Non-    (a) Ecotoxicity (aquatic and
 mandatory).                         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-   Description of waste residues and
 mandatory).                         information on their safe handling
                                     and methods of disposal, including
                                     the disposal of any contaminated
                                     packaging.
14. Transport information (Non-     (a) UN number;
 mandatory).
                                    (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-    Safety, health and environmental
 mandatory).                         regulations specific for the
                                     product in question.
16. Other information, including    The date of preparation of the SDS
 date of preparation or last         or the last change to it.
 revision.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-28987 Filed 2-5-21; 8:45 am]
 BILLING CODE 4510-26-P