Hazard Communication Standard, 9576-9831 [2020-28987]
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Proposed Rules
Occupational Safety and Health
Administration
29 CFR Part 1910
[Docket No. OSHA–2019–0001]
RIN 1218–AC93
Hazard Communication Standard
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Proposed rule; request for
comments.
AGENCY:
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.
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SUMMARY:
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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.
DATES:
DEPARTMENT OF LABOR
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ADDRESSES:
Written comments: You may submit
comments and attachments, identified
by Docket No. OSHA–2019–0001,
electronically at https://
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 https://
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 https://
www.regulations.gov. All comments and
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submissions are listed in the https://
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
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).
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.
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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
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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.
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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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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)
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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 nongovernmental 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,
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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 nonflammable 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, https://
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
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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/
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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/standard
interpretations/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
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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 chemicalrelated 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
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,
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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 16section 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).
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,
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).
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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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
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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).
In addition to directly enhancing
worker protections through improved
hazard communication, updating the
5 Holistic programs such as NIOSH’s Total
Worker Health (TWH) program, where behavioral
science is integrated into more traditional riskmanagement practices, require robust hazard
communication practices (Tamers, 2019, Document
ID 0076).
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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).
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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.
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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)
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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)
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(‘‘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
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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 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
6 The last sentence of section 6(b)(7) requires
consultation with the Secretary of Health and
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Section III of this preamble, Events
Leading to the Proposed Modifications
to the Hazard Communication Standard.
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
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.
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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
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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.
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E. Feasibility
Because section 6(b)(5) of the OSH
Act explicitly requires OSHA to set
health standards that eliminate risk ‘‘to
the extent feasible,’’ OSHA uses
feasibility analysis to make standardssetting 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
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B. Solicitation of Comments
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.
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
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.
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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.
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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.
BILLING CODE 4510–26–P
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4. OMB Control Number: 1218–0072.
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5. Affected Public: Business or other
for-profit.
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6. Number of Respondents: 2,206,700.
7. Frequency of Responses: Varies.
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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.
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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: https://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
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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
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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.
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 SubCommittee 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 workerprotective, efficient, and effective
through standardizing practices
nationally and internationally. In
addition, aligning with the GHS Rev. 7
would continue to facilitate
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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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
Æ Adding classification categories for
aerosols, desensitized explosives,
and flammable gases; and
Æ Updating select hazard and
precautionary statements for clearer
and more precise hazard
information.
• Address issues identified in
implementing the HCS 2012
Æ Updating labeling requirements for
small containers; and
Æ 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,
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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
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
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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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
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/USChemicals-Trade-by-the-Numbers.pdf, accessed
October 2, 2020 (Document ID 0235).
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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.
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.
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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.
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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).
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
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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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.)
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
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).
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).
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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
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revenues) available from the U.S.
Census Bureau (2020a; 2020b).16
16 U.S. Census Bureau, Statistics of U.S.
Businesses, 2017 https://www.census.gov/data/
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(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
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classification criteria for select hazards
and labels on very small containers) are
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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
9607
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.
TABLE VII–4—CHEMICAL CONTAINER ESTIMATED TYPICAL SHIPMENT WEIGHTS
Estimated shipment weight (lbs.)
Container type
Minimum
3 ml container ..................................................................................................
30 ml container ................................................................................................
60 ml container ................................................................................................
125 ml container ..............................................................................................
250 ml container ..............................................................................................
500 ml container ..............................................................................................
1 liter container ................................................................................................
2 liter container ................................................................................................
1 gallon container ............................................................................................
2.5 gallon container .........................................................................................
5 gallon drum ...................................................................................................
30 gallon drum .................................................................................................
55 gallon drum .................................................................................................
275 gallon tote .................................................................................................
330 gallon tote .................................................................................................
Tank Truck—5.5k g .........................................................................................
Tank Truck—7.0k g .........................................................................................
Rail Car—20k g ...............................................................................................
Rail Car—30k g ...............................................................................................
Barge ...............................................................................................................
0.01
0.06
0.12
0.25
0.50
0.92
1.84
3.57
6.83
18.00
34.95
202.00
371.00
1,830.00
2,196.00
34,100.00
43,400.00
128,805.00
186,000.00
2,670,774.00
Typical
0.01
0.08
0.16
0.33
0.67
1.26
2.51
4.92
9.38
24.38
47.71
278.56
511.37
2,531.84
3,038.21
48,136.79
61,265.00
181,825.77
262,564.29
3,770,160.58
Maximum
Number of
labels per
container a
0.01
0.13
0.26
0.54
1.08
2.08
4.16
8.22
15.63
40.00
78.95
466.00
855.00
4,250.00
5,100.00
82,500.00
105,000.00
311,625.00
450,000.00
6,461,550.00
1.13
1.13
1.13
1.13
1.13
1.13
1.25
1.25
1.25
1.50
1.00
1.00
1.00
1.00
1.00
0.00
0.00
0.00
0.00
0.00
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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
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
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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.
BILLING CODE 4510–26–P
an additional label for every eight containers
smaller than 1 liter.
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OSHA’s estimate of the total number
of SDSs per NAICS industry, as
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presented in Table VII–5, was
developed by its contractor to support
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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.
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 jointlyproduced Commodity Flow Survey
(CFS) (U.S. Census Bureau, 2014a,
Document ID 0024) data on shipment
characteristics by commodity and
shipment weight. This dataset includes
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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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.
The next step in the methodology
estimated the representative weight per
container for a variety of types of
containers (ranging in size from a 3milliliter 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 × 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 nonconsumer hazardous pounds in each
container type was divided by the
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.
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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
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
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).
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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
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(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
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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.
BILLING CODE 4510–26–P
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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Table VI–8 shows average estimated
profit rates for affected NAICS
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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).
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23 IRS,
2016, Document ID 0004.
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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
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
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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.
a percentage of product, rather than a percentage of
entities or establishments, that would be affected.
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BILLING CODE 4510–26–C
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9629
TABLE VII–11—CHARACTERISTICS OF INDUSTRIES AND LABELS/SDSS AFFECTED BY OSHA’S PROPOSED REVISIONS TO
THE HCS a
Percentage
affected
Total
Firms ............................................................................................................................................
Establishments .............................................................................................................................
Relevant Employees ....................................................................................................................
Labels Being Revised Due to Chemical Reclassification and Labels Revisions ........................
Labels for Very Small Containers ................................................................................................
Firms w/Warehoused Labels that Change ..................................................................................
SDSs ............................................................................................................................................
6,077,430
7,780,863
148,004,068
1,512,219,200
147,599,473
230
1,519,506
1.91
1.96
2.82
63.55
17.21
1.00
94.40
Affected
115,758
152,427
4,178,738
961,053,993
25,394,066
2.30
1,434,377
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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 AnalysisHealth.
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.
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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, shrinkwrapped, 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
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
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invites interested parties to provide
comments and evidence on how the
proposed revisions to the HCS are likely
to affect worker safety and health.
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
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)
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).
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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
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
27 https://2009-2017.state.gov/e/oes/eqt/
chemicalpollution/83012.htm (SAICM, 2006,
Document ID 0039).
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breaking down pallets of sealed, shrinkwrapped 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-forshipment 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
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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
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
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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).
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 casespecific. 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
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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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Crystalline Silica (81 FR 16285, 16488–
16492 (March 25, 2016)).29
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 × .458
= $16.32; $35.63 × 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
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).
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).
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Specialist, SOC code 19–5011, $58.00.
(For further details, see Document ID
0049, tab ‘‘Wages’’.)
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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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
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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
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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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.
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).
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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
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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
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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.
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OSHA derived the number of directly
affected electronic files for SDSs and
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labels in Column 4 of Table VII–13 by
applying the 50 percent factor to the
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overall number of affected SDSs
(electronic files) from Table VII–5. For
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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.
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.
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.
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.
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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Table VII–14 shows the estimated
costs associated with modifications to
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to conform to formatting and language
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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
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
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.
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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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.
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).
Multiplying the number of affected
SDSs (electronic files) by the unit cost
of Health and Safety Specialists, and
accounting for the relevant noncompliance 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
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.
38 That is, mathematically, (1—the relevant
baseline compliance rate). Estimated noncompliance rates are shown in Column 6 of Table
VI–14 by employment size for each affected NAICS
industry.
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9651
interested parties to provide comments
on these cost estimates and the
assumptions underlying them.
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.
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,
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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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
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 managementfamiliarization 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]
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Small
establishments
(<20 employees)
affected
Medium
establishments
(20–499 employees)
affected
Large
establishments
(≥ 500 employees)
affected
Total
Directly Affected Establishments
Total Establishments ............................................................................................
Wage ....................................................................................................................
Hours ....................................................................................................................
Unit Cost Per Establishment ................................................................................
Total One-Time Cost ...........................................................................................
38,018
$58.00
0.50
$29.00
$1,102,609
11,273
$58.00
2.00
$116.01
$1,307,771
394
$58.00
8.00
$464.04
$182,830
49,685
......................
......................
......................
$2,593,210
Total Annualized Cost (7%) ..........................................................................
$156,987
$186,197
$26,031
$369,215
Indirectly Affected Establishments
Total Establishments ............................................................................................
Wage ....................................................................................................................
Hours ....................................................................................................................
Unit Cost Per Establishment ................................................................................
Total One-Time Cost ...........................................................................................
79,500
$58.00
0.25
$14.50
$1,152,841
22,657
$58.00
1.00
$58.00
$1,314,209
467
$58.00
4.00
$232.02
$108,353
102,624
......................
......................
......................
$2,575,403
Total Annualized Cost (7%) ..........................................................................
$164,139
$187,114
$15,427
$366,679
Total
Total Establishments ............................................................................................
Total One-Time Cost ...........................................................................................
117,518
$2,255,450
33,930
$2,621,980
861
$291,183
152,309
$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.
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
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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
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the ‘‘Rule Fam’’ tab of the OSHA spreadsheet in
support of this proposed rule (see Document ID
0049).
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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.
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 nonflammable 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 nonflammable 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.
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.
TABLE VII–16—TRAINING COSTS ASSOCIATED WITH THE PROPOSED REVISIONS TO THE HCS STANDARD
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[2019 Dollars]
Health & safety
specialist hours
per firm to
prepare training
Logistics
personnel hours
per emp. to
receive training
Production
worker hours per
emp. to receive
training
Total
Affected Firms .............................................................................................................
Employees Needing Training ......................................................................................
Wage ...........................................................................................................................
Hours ...........................................................................................................................
Unit Cost .....................................................................................................................
Total One-Time Cost ...................................................................................................
2,754
..............................
$58.00
2.5
$145.01
$399,289
..................................
1,179
$58.51
0.2
$11.70
$13,796
................................
76,447
$28.18
0.2
$5.64
$430,855
2,754
78,489
......................
2.9
$162.35
$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.
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.
43 OSHA anticipates that, in practice, training
would be organized more efficiently at the
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corporate (firm) level than at the establishment
level.
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
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calculated by matching the NAICS codes with
training costs from Table VI–12 with the number of
affected firms in the identical NAICS codes in Table
VI–1 and multiplying by 50 percent (only 50
percent are estimated to require training).
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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.
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
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.
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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).
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
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).
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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.
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
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).
48 A review of the products covered under the
manufacturing NAICS codes reveals they are all, or
almost all, chemicals.
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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
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.
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-forshipment provision.
TABLE VII–17—CALCULATION OF THE PERCENTAGE LOSS AVOIDED DUE TO THE PROPOSED RELEASED-FOR-SHIPMENT
PROVISION
[2019 Dollars]
NAICS
325311
325312
325314
325510
424910
424950
NAICS industry
...........
...........
...........
...........
...........
...........
Percentage
cost
savings
Percentage of
products
warehoused
≥ six months
Percentage of
products
warehoused
≥ six months
and require
relabeling
Percentage of
products
covered by the
proposed rule
Product of
percentages
(A)
(B)
(C)
(D)
(A), (B), (C), and
(D)
Nitrogenous Fertilizer Manufacturing ...............................
Phosphatic Fertilizer Manufacturing .................................
Fertilizer (Mixing Only) Manufacturing .............................
Paint and Coating Manufacturing .....................................
Farm Supplies Merchant Wholesalers .............................
Paint, Varnish, and Supplies Merchant Wholesalers .......
50
50
50
50
50
50
5
5
5
5
5
5
1
1
1
1
1
1
100
100
100
100
41.70
77.60
0.03
0.03
0.03
0.03
0.01
0.02
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]
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NAICS
325311
325312
325314
325510
424910
424950
........
........
........
........
........
........
Nitrogenous Fertilizer Manufacturing .....................................
Phosphatic Fertilizer Manufacturing ......................................
Fertilizer (Mixing Only) Manufacturing ...................................
Paint and Coating Manufacturing ..........................................
Farm Supplies Merchant Wholesalers ...................................
Paint, Varnish, and Supplies Merchant Wholesalers ............
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
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(revenue)
NAICS industry
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$37,902,969
127,231,784
13,737,854
28,813,229
28,809,209
18,022,834
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
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Affected
firms
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163
45
359
998
4,965
1,012
Loss avoided
as a % of
revenue
0.03
0.03
0.03
0.03
0.01
0.02
Loss
avoided
$1,544,546
1,431,358
1,232,972
7,188,901
14,911,683
3,538,387
to be negligible, as OSHA believes this is already
standard industry practice.
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.
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TABLE VII–18—COST SAVINGS ASSOCIATED WITH THE PROPOSED RELEASED-FOR-SHIPMENT PROVISION—Continued
[2019 Dollars]
NAICS industry
Average
product
value
(revenue)
................................................................................................
........................
NAICS
Total .....
Affected
firms
7,542
Loss avoided
as a % of
revenue
........................
Loss
avoided
29,847,846
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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).
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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
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
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.
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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
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).
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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.
TABLE VII–19—ESTIMATED COST SAVINGS ASSOCIATED WITH ABBREVIATED LABELS ON VERY SMALL CONTAINERS
UNDER THE PROPOSED HCS STANDARD
[2019 Dollars]
NAICS
325180
325199
325411
325412
325413
325414
Labels—
very small
containers
NAICS industry
Percentage
of labels
with cost
savings
Labels
w/cost
savings
Annual cost
savings
........
........
........
........
........
........
Other Basic Inorganic Chemical Manufacturing ....................
All Other Basic Organic Chemical Manufacturing .................
Medicinal and Botanical Manufacturing .................................
Pharmaceutical Preparation Manufacturing ...........................
In-Vitro Diagnostic Substance Manufacturing .......................
Biological Product (except Diagnostic) Manufacturing ..........
14,768,423
35,524,371
5,106,176
6,471,452
501,664
1,113,080
40
40
40
40
40
40
5,907,369
14,209,748
2,042,471
2,588,581
200,665
445,232
$300,518
722,874
103,904
131,685
10,208
22,650
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.
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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.
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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
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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.
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TABLE VII–20—SENSITIVITY TESTS AND REGULATORY ALTERNATIVES—IMPACTS ON NET COST SAVINGS
[7 Percent discount rate, 2019 dollars]
Difference from
proposed rule
Percentage
impact on
net cost
savings
Net cost
savings
Uncertainty (cost) scenarios
Change from OSHA’s best estimate
Proposed Rule—OSHA’s midpoint estimate .................
Reduce from 1 percent to 0.5 percent the percentage
of products warehoused for more than six months
that would require relabeling in any particular year.
Increase from 1 percent to 2 percent the percentage
of products warehoused for more than six months
that would require relabeling in any particular year.
Reduce from 40% to 20% the percentage of very
small containers that would be affected by proposed
paragraph (f)(12).
Rule familiarization time would not be reduced for
firms that are not affected by any other cost provisions; it would be identical to rule familiarization
time for those that are affected by other provisions.
Doubles labor hours for the reclassification of chemicals and compliance with the new mandatory language in the appendices to the proposed standard.
Excludes overhead costs from fully loaded hourly
wage rates.
N/A ................................................................................
Halves cost savings associated with proposed released-for-shipment provision.
$0
¥$14,923,923
0.0
¥55.8
$26,753,711
11,829,788
Doubles cost savings associated with proposed released-for-shipment provision.
29,847,846
111.6
56,601,557
Halves cost savings for affected firms ..........................
¥645,919
¥2.4
26,107,792
Raises costs for the 31,577 establishments in NAICS
31–33—Manufacturing, and the 71,047 establishments in NAICS 42—Wholesale Trade not affected
by other provisions.
Doubles labor costs for the approximately 13 six-digit
NAICS industries affected by proposed changes to
paragraph (d) and appendices B, C, and D.
For the four job categories in the cost model, overhead costs (17 percent of base wages) are not applied and estimated wage rates are correspondingly
lower.
Eliminates cost savings for affected employers ...........
¥366,679
¥1.4
26,387,032
¥3,529,921
¥13.2
23,223,790
458,003
1.7
27,211,714
¥1,291,839
¥4.8
25,461,873
¥29,847,846
¥111.6
¥3,094,135
Remove the proposed provisions that result in cost
savings for very small labels.
Eliminate the proposed released-for-shipment provisions and associated cost savings.
Eliminates cost savings for affected employers ...........
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health (Document ID 0049, tab ‘‘Tables’’).
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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
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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.
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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.
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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.
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
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
55 Document ID OSHA–2010–0034–4247,
Attachment ‘‘Silica FEA Chapter VI: Economic
Feasibility Analysis and Regulatory Flexibility
Determination’’ (Document ID 0045).
56 Document ID OSHA–2010–0034–4247,
Attachment ‘‘Silica FEA Chapter VI: Economic
Feasibility Analysis and Regulatory Flexibility
Determination’’ (Document ID 0045).
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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 nonmonetized 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.
BILLING CODE 4510–26–P
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In the case of costs that may be
incurred due to the requirements of the
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proposed revisions to the HCS, all
businesses within each of the covered
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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.
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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
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agency invites comments on this
preliminary conclusion.
one percent of revenues or five percent
of profits.57
H. Preliminary Regulatory Flexibility
Act Certification
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.
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
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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.
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BILLING CODE 4510–26–C
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 OSHAapproved 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
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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).
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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
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A. Issues
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.
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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).
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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 markedup 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
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9687
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
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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) (releasedfor-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).
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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-bycase 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,
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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
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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.
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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,
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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
§ 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 Subcommittee, 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
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‘‘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.
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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 nonflammable 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
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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 releasedfor-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 Releasedfor-Shipment Provision. OSHA requests
public comments on its estimates for
each of the four factors described above
and shown in Table VI–17.
(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
58 That is, a labeling change resulting from new
information obtained by the manufacturer and not
from a new legal requirement.
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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
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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
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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
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9691
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
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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
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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
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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
(§ 1910.1200, appendix B). OSHA has
preliminarily determined that there are
no substantive differences between
OSHA’s current text and the text
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represented in the new Rev. 8 table
(reproduced below), although they do
9693
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.
(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.
(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.
2 ........................
3 ........................
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
Code
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P316 ......
P317 ......
P318 ......
Response precautionary
statements
Get emergency medical
help immediately.
Get medical help .................
If exposed or concerned,
get medical advice.
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Hazard class
Hazard category
Acute toxicity, oral (chapter 3.1) .....
Acute toxicity, dermal (chapter 3.1)
Acute toxicity, inhalation (chapter
3.1).
Skin corrosion (chapter 3.2) ...........
Respiratory sensitization (chapter
3.4).
Specific target organ toxicity, single
exposure; (chapter 3.8).
Aspiration hazard (chapter 3.10) ....
Gases under pressure (chapter 2.5)
Acute toxicity, oral (chapter 3.1) .....
Acute toxicity, dermal (chapter 3.1)
Acute toxicity, inhalation (chapter
3.1).
Skin irritation (chapter 3.2) .............
Serious eye damage (chapter 3.3)
Eye irritation (chapter 3.3) ..............
Skin sensitization (chapter 3.4) ......
Germ cell mutagenicity (chapter
3.5).
Carcinogenicity (chapter 3.6) ..........
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2, 3.
2, 3.
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Competent Authority or manufacturer/supplier may
add, ‘Call’ followed by the appropriate emergency
telephone number, or the appropriate emergency
medical help provider, for example, a Poison Centre, Emergency Centre or Doctor.
1, 1A, 1B.
1, 2.
1, 2.
Refrigerated liquefied gas.
4, 5.
4, 5.
4, 5.
2, 3.
1.
2/2A, 2B.
1, 1A, 1B.
1, 1A, 1B, 2.
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TABLE XV—REVISED MEDICAL RESPONSE STATEMENTS FROM THE GHS REV. 8—Continued
Code
P319 ......
Response precautionary
statements
Get medical help if you feel
unwell.
Hazard class
Reproductive toxicity (chapter 3.7)
Reproductive toxicity, effects on or
via lactation (chapter 3.7).
Specific target organ toxicity, single
exposure; respiratory tract irritation (chapter 3.8).
Specific target organ toxicity, single
exposure; narcotic effects (chapter 3.8).
Specific target organ 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?
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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
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1, 1A, 1B, 2.
Additional category.
3.
3.
1, 2.
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,
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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
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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 § 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 § 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 § 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)
Æ ASTM D 4359–90 (2019)—Standard
Test Method for Determining Whether a
Material is a Liquid or a Solid, Reapproved 2019: This consensus
standard provides specific details
regarding the test methods used to
determine whether a viscous material is
a liquid or solid.
D ASTM, International: https://
astm.org/Standard/standards-andpublications.html.
Æ 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.
D https://shop.un.org/series/
european-agreement-concerning-
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international-carriage-dangerous-goodsroad-adr.
• Appendix B.1.3—Explosives
Æ 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.
D https://www.unece.org/tans/danger/
publi/manual/maual_e.html.
• Appendix B.2.3—Flammable Gases
Æ 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.
D International Organization for
Standards; https://iso.org/store.html.
Æ 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.
D International Organization for
Standards; https://iso.org/store.html.
Æ 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.
D International Electrotechnical
Commission: https://iec.ch/index/
htm#buy.
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Æ 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 °C) with particular
emphasis on mineral oils hydrocarbons
and their mixtures,
D German Institute of Standards:
https://din.de/en/about-standards/buystandards.
Æ 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.
D https://www.unece.org/tans/danger/
publi/manual/maual_e.html.
• Appendix B.4—Oxidizing Gases
Æ 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.
D https://www.iso.org/store.html.
• Appendix B.14.2—Oxidizing Solids
Æ 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.
D https://www.unece.org/tans/danger/
publi/manual/maual_e.html.
• Appendix B.17.2—Desensitized
Explosives
Æ UN ST/SG/AC.10/30/Rev.6, UN
Recommendations on the Transport of
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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.
D https://www.unece.org/tans/danger/
publi/manual/maual_e.html.
Æ 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.
D https://www.unece.org/tans/danger/
publi/manual/maual_e.html.
• Appendix B.17.3—Desensitized
Explosives
Æ 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.
D 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
§ 1910.6(bb).
Copies of the standards are available
for purchase from the issuing
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organizations at the addresses or
through the other contact information
listed in § 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
§ 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
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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., § 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
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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 °F (50 °C) has a vapor
pressure greater than 43.51 PSI (300
kPa) (absolute); or (ii) is completely
gaseous at 68 °F (20 °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 °C) has a vapor pressure of
not more than 43.51 PSI (300 kPa (3
bar)), which is not completely gaseous
at 680F (20 °C) and at a standard
pressure of 101.3 kPa, and which has a
melting point or initial melting point of
68 0F (20 °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
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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); selfheating; 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
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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
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(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 § 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
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CFR, paragraph (e)(4) references
§ 1910.20 instead of § 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.
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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 55gallon drum containing a flammable
liquid, both a DOT label and an OSHAcompliant 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 OSHAcompliant label. This means chemical
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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
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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 2012compliant 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
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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 HCSrequired label information directly on
small containers through the use of pullout 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,
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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
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professionals, emergency responders,
health care professionals, and other
interested parties. While OSHA believes
that information in SDSs has greatly
improved with the standardized, 16section 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
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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 reimplemented 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
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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
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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
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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.
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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
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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
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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
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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.
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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 subcategorization 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.
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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.
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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.
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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
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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
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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
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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
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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.
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• 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 toxicityrepeated 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
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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.
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
59 Specific changes to the hazard and
precautionary statements are discussed below in the
section on appendix C.
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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
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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
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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 nonozone 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 2,3,3,3Tetrafluoropropene 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 subcategories, 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,
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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 newlydeveloped 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
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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 °C (130 °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
§ 1910.1200(c). Therefore, OSHA
proposes to delete those terms in
§ 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 °F (54.4 °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 °C (130 °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
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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 subcharacterized 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 °C (680 °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 °C (680 °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 triplebonds, adjacent or conjugated doublebonds, 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.
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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 nonflammable 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 nonflammable 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
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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 °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 nonflammable 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
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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
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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 nonflammable 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
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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 nonflammable 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.
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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 °C (680 °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.
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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
§ 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
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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
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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
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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
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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
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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
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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,
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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
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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
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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
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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
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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 nonflammable 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 nonflammable 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.
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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.
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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
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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
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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),
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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; selfreactive 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).
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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
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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
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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
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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
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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 selfreacting 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,
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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
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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 nonsparking 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
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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,
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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).
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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.
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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
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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.
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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).
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Eliminate All Ignition Sources, if Safe
To Do So
Fire and Explosion Hazards for Organic
Peroxides (C.4.28)
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).
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).
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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).
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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).
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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’’
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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).
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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 °C and therefore are
unlikely to generate a hazardous
concentration of vapor during storage;
OSHA believes the precautionary
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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).
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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).
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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 dustair 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
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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
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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
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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
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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.
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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
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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
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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).
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.
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.
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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
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.
2. Amend § 1910.6 by:
a. Revising the last sentence of
paragraph (a)(4);
■ b. Adding paragraphs (h)(29) and
(r)(2)(vi);
■ 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);
■ d. Revising paragraph (bb); and
■ e. Adding paragraphs (cc) and (dd).
The revisions and additions read as
follows:
■
■
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Proposed Rules
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 § 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 § 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 § 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
§ 1910.1200. Website: https://
shop.un.org/series/european-agreementconcerning-international-carriagedangerous-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
§ 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: customercare@bernan; website:
https://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:
https://www.renoufbooks.com; and
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(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
§ 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
§ 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/buystandard.
(1) DIN 51794—Determining the
ignition temperature of petroleum
products, 2003, IBR approved for
appendix B to § 1910.1200.
(2) [Reserved]
■ 3. Amend § 1910.1200:
■ a. By revising paragraphs (a)(1) and
(b)(6)(x);
■ b. In paragraph (c):
■ i. By removing the period following
the subject heading and adding a colon
in its place;
■ ii. By adding in alphabetical order
definitions for ‘‘Bulk shipment’’ and
‘‘Combustible dust’’;
■ iii. By revising the definition of
‘‘Exposure or exposed’’;
■ iv. By adding in alphabetical order a
definition for ‘‘Gas’’;
■ v. By revising the definition of
‘‘Hazardous chemical’’;
■ vi. By adding in alphabetical order
definitions for ‘‘Immediate outer
package’’ and ‘‘Liquid’’;
■ vii. By revising the definition of
‘‘Physical hazard’’;
■ viii. By adding in alphabetical order a
definition for ‘‘Physician or other
licensed health are professional
(PLHCP)’’;
■ ix. By removing the definition of
‘‘Pyrophoric gas’’; and
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x. By adding in alphabetical order
definitions for ‘‘Released for shipment’’
and ‘‘Solid’’;
■ c. By revising paragraphs (d)(1), (e)(4),
and (f)(1), (5), and (11);
■ d. By adding paragraph (f)(12);
■ e. By revising paragraphs (g)(2)
introductory text, (g)(10), (i)(1) and (2),
(i)(3) introductory text, and (j); and
■ f. By revising appendices A through D.
The revisions and additions read as
follows:
■
§ 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
°F (50 °C) has a vapor pressure greater
than 43.51 PSI (300 kPa) (absolute); or
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is completely gaseous at 68 °F (20 °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 °F (50 °C) has a vapor
pressure of not more than 43.51 PSI (300
kPa (3 bar)), which is not completely
gaseous at 68 °F (20 °C) and at a
standard pressure of 101.3 kPa, and
which has a melting point or initial
melting point of 68 °F (20 °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
§ 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 § 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.
*
*
*
*
*
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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
§ 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,
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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
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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
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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.
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(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 § 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.
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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-
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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 caseby-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 nonhazardous 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
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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
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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;
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(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
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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.
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A.1.2.3 The preferred test species for
evaluation of acute toxicity by the oral and
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inhalation routes is the rat, while the rat or
rabbit are preferred for evaluation of acute
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dermal toxicity. Test data already generated
for the classification of chemicals under
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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
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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
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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:
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A.1.3.4 Classification of Mixtures Where
Acute Toxicity Test Data Are Available for
the Complete Mixture
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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
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.
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procedures presented below must be
followed.
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 ×
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:
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
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:
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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.
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such as epidemiological and clinical studies
and well-documented case reports and
observations.
A.2.2
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
Classification Criteria for Substances
Substances shall be allocated to one of the
following categories within this hazard class:
(a) Category 1 (skin corrosion)
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 .....................
Sub-category 1A ............
Sub-category 1B ............
Sub-category 1C ............
a The
Destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least one tested
animal after exposure ≤4 h.
Corrosive responses in at least one animal following exposure ≤3 min during an observation period ≤1 h.
Corrosive responses in at least one animal following exposure >3 min and ≤1 h and observations ≤14 days.
Corrosive responses in at least one animal after exposures >1 h and ≤4 h and observations ≤14 days.
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) ........
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a Grading
(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.
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,
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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,
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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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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 Category 1 ..................................................................................................................................................
Skin Category 2 ..................................................................................................................................................
(10 × Skin Category 1) + Skin Category 2 .........................................................................................................
Skin corrosive
Skin irritant
Category 1
Category 2
≥5%
............................
............................
≥1% but <5%
≥10%
≥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%.
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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
Ingredient:
Concentration:
Acid with pH ≤2 .........................................................................................................
Base with pH ≥11.5 ...................................................................................................
Other corrosive (Category 1) ingredient ....................................................................
Other irritant (Category 2) ingredient, including acids and bases ............................
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≥1%
≥1%
≥1%
≥3%
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Serious Eye Damage/Eye Irritation
A.3.1 Definitions and General
Considerations
A.3.1.1 Serious eye damage refers to the
production of tissue damage in the eye, or
serious physical decay of vision, which is not
fully reversible, occurring after exposure of
the eye to a substance or mixture.
Eye irritation refers to the production of
changes in the eye, which are fully
reversible, occurring after exposure of the eye
to a substance or mixture.
A.3.1.2 Serious eye damage/eye irritation
shall be classified using a tiered approach as
detailed in Figure A.3.1. Emphasis shall be
placed upon existing human data (See
A.0.2.6), followed by existing animal data,
followed by in vitro data and then other
sources of information. Classification results
directly when the data satisfy the criteria in
this section. In case the criteria cannot be
directly applied, classification of a substance
or a mixture is made on the basis of the total
weight of evidence (See A.0.3.1). This means
that all available information bearing on the
determination of serious eye damage/eye
irritation is considered together, including
the results of appropriate scientifically
validated in vitro tests, relevant animal data,
and human data such as epidemiological and
clinical studies and well-documented case
reports and observations.
A.3.2
Classification Criteria for Substances
Substances are allocated to one of the
categories within this hazard class, Category
1 (serious eye damage) or Category 2 (eye
irritation), as follows:
(a) Category 1 (serious eye damage/
irreversible effects on the eye): Substances
that have the potential to seriously damage
the eyes (see Table A.3.1).
(b) Category 2 (eye irritation/reversible
effects on the eye): Substances that have the
potential to induce reversible eye irritation
(see Table A.3.2).
A.3.2.1 Classification based on standard
animal test data.
A.3.2.1.1 Serious eye damage (Category
1)/Irreversible effects on the eye.
A single hazard category is provided in
Table A.3.1, for substances that have the
potential to seriously damage the eyes.
Category 1, irreversible effects on the eye,
includes the criteria listed below. These
observations include animals with grade 4
cornea lesions and other severe reactions
(e.g., destruction of cornea) observed at any
time during the test, as well as persistent
corneal opacity, discoloration of the cornea
by a dye substance, adhesion, pannus, and
interference with the function of the iris or
other effects that impair sight. In this context,
persistent lesions are considered those which
are not fully reversible within an observation
period of normally 21 days. Category 1 also
contains substances fulfilling the criteria of
corneal opacity ≥3 and/or iritis >1.5 observed
in at least 2 of 3 tested animals detected in
a Draize eye test with rabbits, because severe
lesions like these usually do not reverse
within a 21-day observation period.
TABLE A.3.1—SERIOUS EYE DAMAGE/IRREVERSIBLE EFFECTS ON THE EYE CATEGORY a
Criteria
Category 1: Serious eye
damage/Irreversible effects on the eye.
a Grading
A substance that produces:
(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.
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
Category 2/2A .................
Category 2B ....................
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a Grading
Substances that have the potential to induce reversible eye irritation.
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.
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.
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
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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.
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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.
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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
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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.
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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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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:
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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
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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 cutoff 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).
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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
Skin corrosion (Category 1) + Serious eye damage (Category 1) a ...........................................................
Eye irritation (Category 2) ............................................................................................................................
10 × (Skin corrosion (Category 1) + Serious eye damage (Category 1)) a + Eye irritation (Category 2) ...
Serious eye damage
Eye irritation
Category 1
Category 2/2A
≥3%
....................................
....................................
≥1% but <3%.
b ≥10%.
≥10%.
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
(%)
Ingredient
Acid with pH ≤2 ..........................................................................
Base with pH ≥11.5 ...................................................................
Other skin corrosive or serious eye damage (Category 1) ingredients.
Other eye irritant (Category 2) ingredients ................................
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
Mixture classified as:
≥1
≥1
≥1
Serious eye damage (Category 1).
Serious eye damage (Category 1).
Serious eye damage (Category 1).
≥3
Eye irritation (Category 2).
sensitization. For skin sensitization, an
induction phase is required in which the
immune system learns to react; clinical
symptoms can then arise when subsequent
exposure is sufficient to elicit a visible skin
reaction (elicitation phase). As a
consequence, predictive tests usually follow
this pattern in which there is an induction
phase, the response to which is measured by
a standardized elicitation phase, typically
involving a patch test. The local lymph node
assay is the exception, directly measuring the
induction response. Evidence of skin
sensitization in humans normally is assessed
by a diagnostic patch test.
A.4.1.4 Usually, for both skin and
respiratory sensitization, lower levels are
necessary for elicitation than are required for
induction.
A.4.1.5 The hazard class ‘‘respiratory or
skin sensitization’’ is differentiated into:
(a) Respiratory sensitization; and
(b) Skin sensitization.
A.4.2
Classification Criteria for Substances
A.4.2.1
Respiratory Sensitizers
A.4.2.1.1 Hazard categories
A.4.2.1.1.1 Effects seen in either humans
or animals will normally justify classification
in a weight of evidence approach for
respiratory sensitizers. Substances may be
allocated to one of the two sub-categories 1A
or 1B using a weight of evidence approach
in accordance with the criteria given in Table
A.4.1 and on the basis of reliable and good
quality evidence from human cases or
epidemiological studies and/or observations
from appropriate studies in experimental
animals.
A.4.2.1.1.2 Where data are not sufficient
for sub-categorization, respiratory sensitizers
shall be classified in Category 1.
TABLE A.4.1—HAZARD CATEGORY AND SUB-CATEGORIES FOR RESPIRATORY SENSITIZERS
Category 1:
Respiratory sensitizer
Sub-category 1A: ............
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Sub-category 1B: ............
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
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.
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.
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.
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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:
(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
Sub-category 1A: ............
Sub-category 1B: ............
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.
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.
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 subcategory 1A may include:
(a) Positive responses at ≤500 mg/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 subcategory 1B may include:
(a) Positive responses at >500 mg/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
A.4.2.2.3.2 Animal test results for subcategory 1A can include data with values
indicated in Table A.4.3 below:
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TABLE A.4.3—ANIMAL TEST RESULTS FOR SUB-CATEGORY 1A
Assay
Criteria
Local lymph node assay
Guinea pig maximization
test.
EC3 value ≤2%.
≥30% responding at ≤0.1% intradermal induction dose or ≥60% responding at >0.1% to ≤1% intradermal induction
dose.
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
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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.
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).
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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.
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TABLE A.4.3—ANIMAL TEST RESULTS FOR SUB-CATEGORY 1A—Continued
Assay
Buehler assay .................
Criteria
≥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 subcategory 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
Guinea pig maximization
test.
Buehler assay .................
EC3 value >2%.
≥30% to <60% responding at >0.1% to ≤1% intradermal induction dose or ≥30% responding at >1% intradermal induction dose.
≥15% to <60% responding at >0.2% to ≤20% topical induction dose or ≥15% responding at >20% topical induction
dose.
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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 casecontrol 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
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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 abovementioned 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
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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.
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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
Category 1
Ingredient classified as:
Respiratory Sensitizer: Category 1 ................................................................................
Respiratory Sensitizer: Sub-category 1A ......................................................................
Respiratory Sensitizer: Sub-category 1B ......................................................................
Skin Sensitizer: Category 1 ...........................................................................................
Skin Sensitizer: Sub-category 1A ..................................................................................
Skin Sensitizer: Sub-category 1B ..................................................................................
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
Skin sensitizer
Category 1
Solid/Liquid
(%)
Gas
All physical states
(%)
≥0.1
≥0.1
≥1.0
........................
........................
........................
≥0.1
≥0.1
≥0.2
........................
........................
........................
......................................
......................................
......................................
≥0.1
≥0.1
≥1.0
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.
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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
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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
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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
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
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
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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
9745
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 1A/B mutagen ..................................................................................................................
Category 2 mutagen ........................................................................................................................
Category 1 mutagen
Category 2 mutagen
≥0.1%
....................................
....................................
≥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
A.6.1
Carcinogenicity
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
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, routespecific classification may be warranted.
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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.
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
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the classification to be modified only on a case-bycase evaluation based on available test data for the
mixture as a whole.
6 See Non-mandatory appendix F of this section,
part A for further guidance regarding hazard
classification for carcinogenicity. This appendix is
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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).
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FIGURE A.6.1—HAZARD CATEGORIES FOR CARCINOGENS—Continued
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 onestep, 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
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
Ingredient classified as:
Category 1 carcinogen ....................................................................................................................................
Category 2 carcinogen ....................................................................................................................................
Category 1
carcinogen
Category 2
carcinogen
≥0.1%
............................
............................
≥0.1% (note 1)
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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.
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
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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
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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
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
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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.
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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.
8 See Non-mandatory appendix F of this section
for further guidance regarding hazard classification
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for carcinogenicity and how to relate
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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
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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 nonspecific 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
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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 ×
100).
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(c) Fertility index (Number of animals with
implants/Number of matings × 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.
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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 twogeneration 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.
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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
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.
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-bycase evaluation based on available test data for the
mixture as a whole.
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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 reproductive toxicant .......................................................................................
Category 2 reproductive toxicant .......................................................................................
Additional category for effects on or via lactation .............................................................
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,
Category 1
reproductive
toxicant
Category 2
reproductive
toxicant
≥0.1%
........................
........................
≥0.1%
........................
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
Additional category
for effects on or
via lactation
≥0.1%
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.
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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.
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A.8.2.1.3 Classification is determined by
expert judgment, on the basis of the weight
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guidance presented below.
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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
khammond on DSKJM1Z7X2PROD with PROPOSALS2
Guidance value ranges for:
Route of exposure
Units
Category 1
Category 2
Oral (rat) ............................
mg/kg body weight ............
C ≤ 300 .............................
2,000 ≥ C > 300 ................
Dermal (rat or rabbit) .........
Inhalation (rat) gas ............
Inhalation (rat) vapor .........
Inhalation (rat) dust/mist/
fume.
mg/kg body weight ............
ppmV/4h ............................
mg/1/4h .............................
mg/l/4h ..............................
C
C
C
C
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.
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≤
≤
≤
≤
1,000 ..........................
2,500 ..........................
10 ...............................
1.0 ..............................
2,000 ≥ C > 1,000.
20,000 ≥ C > 2,500.
20 ≥ C > 10.
5.0 ≥ C > 1.0.
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
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Category 3
Guidance values do not
apply.
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
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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 as:
Ingredient classified as:
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Category 1: Target organ toxicant ...........................................................................................................................
Category 2: Target organ toxicant ...........................................................................................................................
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
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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
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Category 1
Category 2
≥1.0%
........................
........................
≥1.0%
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
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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
9753
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).
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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
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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
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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
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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
(dose/concentration)
Route of exposure
Units
Oral (rat) .............................................................
Dermal (rat or rabbit) .........................................
Inhalation (rat) gas .............................................
Inhalation (rat) vapor ..........................................
Inhalation (rat) dust/mist/fume ...........................
mg/kg body weight/day ....................................
mg/kg body weight/day ....................................
ppmV/6h/day ....................................................
mg/liter/6h/day ..................................................
mg/liter/6h/day ..................................................
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
C
C
C
C
C
≤10
≤20
≤50
≤0.2
≤0.02
as indicated in Table A.9.2 would justify
classification:
TABLE A.9.2—GUIDANCE VALUES TO ASSIST IN CATEGORY 2 CLASSIFICATION
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[Applicable to a 90-day study]
Guidance value range
(dose/concentration)
Route of exposure
Units
Oral (rat) .............................................................
Dermal (rat or rabbit) .........................................
Inhalation (rat) gas .............................................
Inhalation (rat) vapor ..........................................
Inhalation (rat) dust/mist/fume ...........................
mg/kg body weight/day ....................................
mg/kg body weight/day ....................................
ppmV/6h/day ....................................................
mg/liter/6h/day ..................................................
mg/liter/6h/day ..................................................
A.9.2.9.8 The guidance values and ranges
mentioned in A.2.9.9.6 and A.2.9.9.7 are
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be used as part of the weight of evidence
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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
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Category 2
≥1.0%
........................
........................
≥1.0%
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:
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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
cause human aspiration toxicity
hazards or to be regarded as if
they cause human aspiration toxicity hazard.
A substance shall be classified in Category 1:
(a) If reliable and good quality human evidence indicates that it causes aspiration toxicity (See note);
or
(b) If it is a hydrocarbon and has a kinematic viscosity ≤20.5 mm2/s, measured at 40 °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%.
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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 °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 °C.
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Appendix B to § 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 selfsustaining 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
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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 § 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
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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 § 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 § 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.
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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
§ 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
§ 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 → x. CO2 +
(y/2) H2O
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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 °C
(932 °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
B.2.1
Flammable Gases
Definition
Flammable gas means a gas having a
flammable range with air at 20 °C (68 °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 °C (130 °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:
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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 § 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
§ 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 °F (54 °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 § 1910.6) or
DIN 51794 (2003) (Determining the ignition
temperature of petroleum products)
(incorporated by reference; see § 1910.6).
B.2.3.3 The classification procedure for
pyrophoric gases need not be applied when
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experience in production or handling shows
that the substance does not ignite
spontaneously on coming into contact with
air at a temperature of 130 °F (54 °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 § 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 § 1910.6)
show that a gas mixture is not flammable, no
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additional testing is required for determining
chemical instability for classification
purposes.
B.3
B.3.1
Aerosols
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 waterreactive chemicals.
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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.
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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.
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.
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.
2 ........................
3 ........................
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
where:
DHc = chemical heat of combustion (kJ/g);
wi% = mass fraction of component i in the
product;
DHc(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 § 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
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
(DHc), in kilojoules per gram (kJ/g), is the
product of the theoretical heat of combustion
(DHcomb), 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:
and 31.6 of the of the UN ST/SG/AC.10
(incorporated by reference; See § 1910.6).
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 § 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
§ 1910.6) or an equivalent testing method).
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—
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:
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
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reference; see § 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 § 1910.6).
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B.5
B.5.1
Gases Under Pressure
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 °C (68 °F),
or which are liquefied or liquefied and
refrigerated.
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TABLE B.4.1—CRITERIA FOR OXIDIZING GASES
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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 °C (¥58 °F), including all gases with a critical temperature 1 ≤¥50 °C (¥58 °F).
A gas which when under pressure, is partially liquid at temperatures above ¥50 °C (¥58 °F). A distinction is
made between:
(a) High pressure liquefied gas: A gas with a critical temperature1 between ¥50 °C (¥58 °F) and +65 °C
(149 °F); and
(b) Low pressure liquefied gas: A gas with a critical temperature 1 above +65 °C (149 °F).
A gas which is made partially liquid because of its low temperature.
A gas which when under pressure is dissolved in a liquid phase solvent.
Liquefied gas ........................
Refrigerated liquefied gas ....
Dissolved gas .......................
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 °C (199.4 °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
1
2
3
4
Criteria
........................
........................
........................
........................
Flash
Flash
Flash
Flash
point
point
point
point
<23 °C (73.4 °F) and initial boiling point ≤35 °C (95 °F).
<23 °C (73.4 °F) and initial boiling point >35 °C (95 °F).
≥23 °C (73.4 °F) and ≤60 °C (140 °F).
>60 °C (140 °F) and ≤93 °C (199.4 °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 § 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 § 1910.6).9
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 § 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
§ 1910.6), in accordance with Table B.7.1:
TABLE B.7.1—CRITERIA FOR FLAMMABLE SOLIDS
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Category
Criteria
1 ........................
2 ........................
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.
Burning rate test:
9 To determine the appropriate flammable liquid
storage container size and type, the boiling point
shall be determined by methods specified under
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§ 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
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TABLE B.7.1—CRITERIA FOR FLAMMABLE SOLIDS—Continued
Category
Criteria
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
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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 °C
(167 °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 selfreactive 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 (selfaccelerating decomposition temperature is 60
°C (140 °F) to 75 °C (167 °F) for a 50 kg (110
lb) package), and, for liquid mixtures, a
diluent having a boiling point greater than or
equal to 150 °C (302 °F) is used for
desensitization will be defined as selfreactive chemical TYPE G. If the mixture is
not thermally stable or a diluent having a
boiling point less than 150 °C (302 °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
§ 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
§ 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 § 1910.6); or
(b) For a single organic substance or a
homogeneous mixture of organic substances,
the estimated SADT is greater than 75 °C (167
°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 § 1910.6)).
B.9
B.9.1
Pyrophoric Liquids
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
§ 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.
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B.9.3 Additional Classification
Considerations
be stable at room temperature for prolonged
periods of time (days)).
five minutes after coming into contact with
air.
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
B.10
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
§ 1910.6), in accordance with Table B.10.1:
Pyrophoric Solids
B.10.1
Definition
Pyrophoric solid means a solid which, even
in small quantities, is liable to ignite within
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 § 1910.6), the
result meets the criteria shown in Table
B.11.1.
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TABLE B.11.1—CRITERIA FOR SELF-HEATING CHEMICALS
Category
Criteria
1 ........................
2 ........................
A positive result is obtained in a test using a 25 mm sample cube at 140 °C (284 °F).
A negative result is obtained in a test using a 25 mm cube sample at 140 °C (284 °F), a positive result is obtained in a test
using a 100 mm sample cube at 140 °C (284 °F), and:
(a) The unit volume of the chemical is more than 3 m3; or
(b) A positive result is obtained in a test using a 100 mm cube sample at 120 °C (248 °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 °C (212 °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°C
(122 °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 °C
(122 °F) for a volume of 450 liters shall not
be classified in Category 1 of this class.
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B.11.3 Additional Classification
Considerations
°K above the reference temperature for a
volume of 1 l.
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 °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
B.12 Chemicals Which, in Contact With
Water, Emit Flammable Gases
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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, subsection 33.4.1.4 of the UN ST/SG/AC.10
(incorporated by reference; See § 1910.6), in
accordance with Table B.12.1:
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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.
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.
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.
2 ........................
3 ........................
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
B.13
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.
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 § 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;
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;
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.
2 ........................
3 ........................
B.13.3 Additional Classification
Considerations
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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, subsection 34.4.2 of the UN ST/SG/AC.10
(incorporated by reference; See § 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
§ 1910.6), in accordance with Table B.14.1:
TABLE B.14.1—CRITERIA FOR OXIDIZING SOLIDS
Category
Criteria using test O.1
Criteria using test O.3
1 .........................
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose
ratio (by mass) tested, exhibits a mean burning time less
than the mean burning time of a 3:2 mixture, (by mass), of
potassium bromate and cellulose.
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose
ratio (by mass) tested, exhibits a mean burning rate greater than the mean burning rate of a 3:1 mixture (by mass)
of calcium peroxide and cellulose.
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TABLE B.14.1—CRITERIA FOR OXIDIZING SOLIDS—Continued
Category
Criteria using test O.1
Criteria using test O.3
2 .........................
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose
ratio (by mass) tested, exhibits a mean burning time equal
to or less than the mean burning time of a 2:3 mixture (by
mass) of potassium bromate and cellulose and the criteria
for Category 1 are not met.
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose
ratio (by mass) tested, exhibits a mean burning time equal
to or less than the mean burning time of a 3:7 mixture (by
mass) of potassium bromate and cellulose and the criteria
for Categories 1 and 2 are not met.
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose
ratio (by mass) tested, exhibits a mean burning rate equal
to or greater than the mean burning rate of a 1:1 mixture
(by mass) of calcium peroxide and cellulose and the criteria for Category 1 are not met.
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose
ratio (by mass) tested, exhibits a mean burning rate equal
to or greater than the mean burning rate of a 1:2 mixture
(by mass) of calcium peroxide and cellulose and the 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.
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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
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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:
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),
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(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 (selfaccelerating decomposition temperature is 60
°C (140 °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
°C (302 °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
°C (302 °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
§ 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 § 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.
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B.16
B.16.1
Corrosive to Metals
will materially damage, or even destroy,
metals.
Definition
A chemical which is corrosive to metals
means a chemical which by chemical action
B.16.2 Classification criteria
A chemical which is corrosive to metals
shall be classified in a single category for this
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class, using the test in Part III, sub-section
37.4 of the UN ST/SG/AC.10 (incorporated
by reference; See § 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 °C (131 °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
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
TABLE B.17.1
CRITERIA FOR DESENSITIZED EXPLOSIVES
Category
Criteria
1 ........................
2 ........................
3 ........................
4 ........................
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Transport of Dangerous Goods, Manual of
Tests and Criteria) (incorporated by
reference; see § 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, subsection 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 § 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
§ 1910.6), according to Table B.17.1:
Desensitized
min.
Desensitized
Desensitized
Desensitized
explosives with a corrected burning rate (AC) equal to or greater than 300 kg/min but not more than 1200 kg/
explosives with a corrected burning rate (AC) equal to or greater than 140 kg/min but less than 300 kg/min.
explosives with a corrected burning rate (AC) equal to or greater than 60 kg/min but less than 140 kg/min.
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/
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 § 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
§ 1910.6)) because information about its
sensitiveness to mechanical stimuli is likely to be
important for determining conditions for safe
handling and use. The results shall be
communicated on the safety data sheet.
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AC.10/30/Rev.6 (UN Recommendations on
the Transport of Dangerous Goods, Manual of
Tests and Criteria) (incorporated by
reference; see § 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
§ 1910.6). Testing of solid desensitized
explosives is addressed in section 33, subsection 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
§ 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).
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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
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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 § 1910.6).
Appendix C to § 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
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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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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
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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
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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
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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
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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:
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(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 § 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.
(a) Classification of the chemical in accordance with paragraph (d) of § 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 § 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.
Except as provided for in paragraph (i) of § 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 § 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 § 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 § 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 § 1910.1200(i)(1)(iv).
(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.
(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.
(a) Personal precautions, protective equipment, and emergency procedures.
(b) Methods and materials for containment and cleaning up.
(a) Precautions for safe handling.
(b) Conditions for safe storage, including any incompatibilities.
(a) For all ingredients or constituents listed in Section 3, the OSHA permissible exposure limit (PEL),
American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV), and
any other exposure limit or range used or recommended by the chemical manufacturer, importer, or employer preparing the safety data sheet, where available.
(b) Appropriate engineering controls.
(c) Individual protection measures, such as personal protective equipment.
(a) Physical state.
(b) Color.
(c) Odor.
(d) Melting point/freezing point.
(e) Boiling point (or initial boiling point or boiling range).
(f) Flammability.
2. Hazard(s) identification ...............
3. Composition/information on ingredients.
4. First-aid measures ......................
5. Fire-fighting measures ................
6. Accidental release measures .....
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7. Handling and storage .................
8. Exposure controls/personal protection.
9. Physical and chemical properties
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TABLE D.1—MINIMUM INFORMATION FOR AN SDS—Continued
Heading
Subheading
10. Stability and reactivity ...............
11. Toxicological information ..........
12. Ecological information (Nonmandatory).
13. Disposal considerations (Nonmandatory).
14. Transport information (Nonmandatory).
15. Regulatory information (Nonmandatory).
16. Other information, including
date of preparation or last revision.
*
*
*
*
(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.
(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.
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).
(a) Ecotoxicity (aquatic and terrestrial, where available);
(b) Persistence and degradability;
(c) Bioaccumulative potential;
(d) Mobility in soil;
(e) Other adverse effects (such as hazardous to the ozone layer).
Description of waste residues and information on their safe handling and methods of disposal, including
the disposal of any contaminated packaging.
(a) UN number;
(b) UN proper shipping name;
(c) Transport hazard class(es);
(d) Packing group, if applicable;
(e) Environmental hazards (e.g., Marine pollutant (Yes/No));
(f) Transport in bulk according to IMO instruments;
(g) Special precautions which a user needs to be aware of, or needs to comply with, in connection with
transport or conveyance either within or outside their premises.
Safety, health and environmental regulations specific for the product in question.
The date of preparation of the SDS or the last change to it.
*
[FR Doc. 2020–28987 Filed 2–5–21; 8:45 am]
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Agencies
[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
[[Page 9576]]
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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 https://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
https://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 https://www.regulations.gov. All comments and submissions are
listed in the https://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:
[email protected].
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:
[email protected].
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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[GRAPHIC] [TIFF OMITTED] TP16FE21.000
[[Page 9579]]
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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
[[Page 9580]]
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, https://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
[[Page 9581]]
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).
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\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).
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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.
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\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.
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Authority for the HCS is also found in section 8, paragraphs (c)
and (g), of the OSH Act. Section 8(c)(1) of the OSH Act empowers the
Secretary to require employers to make, keep, and preserve records
regarding activities related to the OSH Act and to make such records
available to the Secretary. 29 U.S.C. 657(c)(1). Section 8(g)(2) of the
OSH Act empowers the Secretary to ``prescribe such rules and
regulations as he may deem necessary to carry out [his]
responsibilities'' under the Act. 29 U.S.C. 657(g)(2).
D. Significant Risk
As required 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.
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\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.
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E. Feasibility
Because section 6(b)(5) of the OSH Act explicitly requires OSHA to
set health standards that eliminate risk ``to the extent feasible,''
OSHA uses feasibility 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:
[email protected]. 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: https://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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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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
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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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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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[[Page 9629]]
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.
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\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).
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\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.
---------------------------------------------------------------------------
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''.)
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\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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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.
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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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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
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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
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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
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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.
---------------------------------------------------------------------------
\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.
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\55\ Document ID OSHA-2010-0034-4247, Attachment ``Silica FEA
Chapter VI: Economic Feasibility Analysis and Regulatory F