[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Proposed Rules]
[Pages 9576-9831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28987]
[[Page 9575]]
Vol. 86
Tuesday,
No. 29
February 16, 2021
Part II
Department of Labor
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Occupational Safety and Health Administration
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29 CFR Part 1910
Hazard Communication Standard; Proposed Rule
Federal Register / Vol. 86 , No. 29 / Tuesday, February 16, 2021 /
Proposed Rules
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2019-0001]
RIN 1218-AC93
Hazard Communication Standard
AGENCY: Occupational Safety and Health Administration (OSHA), Labor.
ACTION: Proposed rule; request for comments.
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SUMMARY: OSHA is proposing through this notice of proposed rulemaking
(NPRM) to modify the Hazard Communication Standard (HCS) to conform to
the United Nations' Globally Harmonized System of Classification and
Labelling of Chemicals (GHS) Revision 7 (GHS, Rev. 7), to address
issues that arose during the implementation of the 2012 update to the
HCS, and provide better alignment with other U.S. agencies and
international trading partners, without lowering overall protections of
the standard. OSHA has preliminarily determined that the proposed
revisions to the HCS will reduce costs and burdens while also improving
the quality and consistency of information provided to employers and
employees regarding chemical hazards and associated protective
measures. Consistent with the Executive order entitled ``Improving
Regulation and Regulatory Review'' (January 18, 2011) and section 3(a)
of the Regulatory Flexibility Act, which call for assessment and, where
appropriate, modification and improvement of existing rules to minimize
any significant economic impact upon a substantial number of small
entities, OSHA has reviewed the existing HCS. The agency has
preliminarily determined that the proposed revisions will enhance the
effectiveness of the HCS by ensuring employees are appropriately
apprised of the chemical hazards to which they may be exposed, thus
reducing the incidence of chemical-related occupational illnesses and
injuries. The proposed modifications to the standard include revised
criteria for classification of certain health and physical hazards,
revised provisions for updating labels, new labeling provisions for
small containers, technical amendments related to the contents of
safety data sheets (SDSs), and related revisions to definitions of
terms used in the standard.
DATES: Comments on this NPRM (including requests for hearing) and other
information must be submitted by April 19, 2021.
Informal public hearing: OSHA will schedule an informal public
hearing on the proposed rule if requested during the comment period. If
a hearing is requested, the location and date of the hearing,
procedures for interested parties to notify the agency of their
intention to participate, and procedures for participants to submit
their testimony and documentary evidence will be announced in the
Federal Register.
ADDRESSES:
Written comments: You may submit comments and attachments,
identified by Docket No. OSHA-2019-0001, electronically at http://www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
the instructions online for making electronic submissions. After
accessing ``all documents and comments'' in the docket (Docket No.
OSHA-2019-0001), check the ``proposed rule'' box in the column headed
``Document Type,'' find the document posted on the date of publication
of this document, and click the ``Comment Now'' link. When uploading
multiple attachments to regulations.gov, please number all of your
attachments because www.regulations.gov will not automatically number
the attachments. This will be very useful in identifying all
attachments in the preamble. For example, Attachment 1_title of your
document, Attachment 2_title of your document, Attachment 3_title of
your document. For assistance with commenting and uploading documents,
please see the Frequently Asked Questions on regulations.gov.
Instructions: All submissions must include the agency's name and
the docket number for this rulemaking (Docket No. OSHA-2019-0001). All
comments, including any personal information you provide, are placed in
the public docket without change and may be made available online at
http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting information they do not want made available to the public,
or submitting materials that contain personal information (either about
themselves or others), such as Social Security Numbers and birthdates.
Docket: To read or download comments and materials submitted in
response to this Federal Register document, go to Docket No. OSHA-2019-
0001 at http://www.regulations.gov. All comments and submissions are
listed in the http://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through that website. All comments and submissions,
including copyrighted material, are available for inspection through
the OSHA Docket Office.\1\
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\1\ Documents submitted to the docket by OSHA or stakeholders
are assigned document identification numbers (Document ID) for easy
identification and retrieval. The full Document ID is the docket
number plus a unique four-digit code. OSHA is identifying supporting
information in this NPRM by author name, publication year, and the
last four digits of the Document ID.
FOR FURTHER INFORMATION CONTACT:
For press inquiries: Contact Frank Meilinger, Director, Office of
Communications, Occupational Safety and Health Administration, U.S.
Department of Labor; telephone: (202) 693-1999; email:
[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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BILLING CODE 4510-26-P
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[GRAPHIC] [TIFF OMITTED] TP16FE21.000
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BILLING CODE 4510-26-C
II. Introduction
This preamble to the proposal to modify the HCS includes a review
of the events leading to the proposal, a discussion of the reasons why
OSHA believes these modifications are necessary, the preliminary
economic and regulatory flexibility analysis for the proposal, and an
explanation of the specific revisions OSHA is proposing to make to the
standard.
III. Events Leading to the Proposed Modifications to the Hazard
Communication Standard
OSHA first promulgated the HCS in 1983, covering only the chemical
manufacturing industry (48 FR 53280). The purpose of the standard was
to provide a standardized approach for communicating workplace hazards
associated with exposure to hazardous chemicals. OSHA updated the HCS
in 1987 to expand coverage to all industries where workers are exposed
to hazardous chemicals (52 FR 31852). In 1994, OSHA promulgated an
additional update to the HCS with technical changes and amendments
designed to ensure better comprehension and greater compliance with the
standard (59 FR 6126). In adopting the original HCS in 1983, the agency
noted the benefits of an internationally harmonized chemical hazard
communication standard (48 FR 53287), and actively participated in
efforts to develop one over the subsequent decades. In 2012, the agency
officially harmonized the HCS with the third revision of the United
Nations' Globally Harmonized System of Classification and Labelling of
Chemicals (GHS) (UN GHS, Rev. 3, 2009, Document ID 0085) (77 FR 17574).
OSHA has always envisioned that the HCS would require periodic
rulemakings to maintain consistency with the GHS and incorporate the
progression of scientific principles and best approaches for
classification and communication of workplace hazards related to
hazardous chemical exposure (77 FR 17574). This section provides
information on the events that have occurred since promulgation of the
2012 HCS, with additional information on the development of the GHS and
its relationship to the HCS, and explains the impetus for this proposed
rule.
Several international and domestic activities have impacted the
direction of the HCS and led to the updates proposed in this NPRM,
including negotiations at the UN, OSHA's participation in the U.S.-
Canada Regulatory Cooperation Council (RCC) with Health Canada, and
information OSHA has received from HCS stakeholders. These are
discussed below.
A. International Events Affecting the Standard
The evolution of what was to become the GHS had its early
beginnings with the work started in 1956 by the United Nations Economic
and Social Council Committee of Experts on the Transport of Dangerous
Goods (TDG) and continued in the 1990s through the United Nations
Conference on Environment and Economic Development (UNCED), the United
Nations International Labour Organization (ILO), and the Organization
for Economic Cooperation and Development (OECD) (UN GHS, 2019, Document
ID 0053). The overarching goal was to provide an internationally
harmonized system to convey information to workers, consumers, and the
general public on the physical, health, and environmental effects of
hazardous chemicals across the globe, as well as to provide a
foundation for the safe management of those chemicals.
Finalized by the UN in 2002, the GHS is intended to harmonize
elements of hazard communication, including SDSs and labels, by
providing a unified classification system of chemicals based on their
physical and health-related hazards. The GHS is updated and revised
every two years based on information and experience gained by
regulatory agencies, industry, and non-governmental organizations (UN
GHS, 2020, Document ID 0052). OSHA largely adopted the third revision
to the GHS in 2012.
OSHA leads the U.S. Interagency GHS Coordinating Group, an
interagency group that serves as a U.S. delegation to the UN. The
Interagency Group works to ensure that modifications to the GHS
continue to reflect U.S. agencies' key priorities and do not conflict
with U.S. hazard communication and associated requirements. The group
meets regularly to discuss issues related to the domestic
implementation of the GHS, as well as international work being done at
the United Nations Sub-Committee of Experts on the GHS (UNSCEGHS). The
Interagency Group consists of representatives from OSHA, the Department
of State, the Department of Transportation (DOT), the Environmental
Protection Agency (EPA), the U.S. Coast Guard, the Consumer Product
Safety Commission (CPSC), the Department of Energy (DOE), the
Department of Defense (DOD), and the Bureau of Alcohol, Tobacco,
Firearms and Explosives (ATF). To date, OSHA is the only U.S. agency to
have implemented the GHS, although CPSC regulations contain elements of
the GHS (e.g., precautionary statements) (CPSC, 2006, Document ID
0175). The EPA (which initiated the U.S. working group) has proposed
changes to its regulations governing significant new uses of chemical
substances under the Toxic Substances Control Act that would align with
the HCS and the GHS as well as OSHA's respiratory protection standard
(29 CFR 1910.134) and National Institute for Occupational Safety and
Health (NIOSH) respirator certification requirements (81 FR 49598).
Since OSHA's adoption of Revision 3 in 2012, the GHS has been
updated five times; the latest revision, Revision 8, was published in
July 2019 (UN GHS, Rev. 8, 2019, Document ID 0065). Updates to the GHS
in Revision 4 (2011) included changes to hazard categories for
chemically unstable gases and non-flammable aerosols and updates to,
and clarification of, precautionary statements (UN GHS, 2011, Document
ID 0240). Changes in Revision 5 of the GHS (2013) included a new test
method for oxidizing solids; miscellaneous provisions intended to
further clarify the criteria for some hazard classes (skin corrosion/
irritation, severe eye damage/irritation, and aerosols) and to
complement the information to be included in the SDS; revised and
simplified classification and labeling summary tables; a new
codification system for hazard pictograms; and revised precautionary
statements (UN GHS, 2013, Document ID 0241).
Revision 6 of the GHS (2015) included a new hazard class for
desensitized explosives and a new hazard category for pyrophoric gases;
miscellaneous provisions intended to clarify the criteria for some
hazard classes (explosives, specific target organ toxicity following
single exposure, aspiration hazard, and hazardous to the aquatic
environment); additional information to be included in section 9 of the
SDS; revised precautionary statements; and a new example in Annex 7
addressing labelling of small packages (UN GHS, 2015, Document ID
0134). Changes in Revision 7 (2017) included revised criteria for
categorization of flammable gases within Category 1; miscellaneous
amendments intended to clarify the definitions of some health hazard
classes; additional guidance regarding the coverage of section 14 of
the SDS (which is non-mandatory under the HCS); and a new example in
Annex 7 addressing labelling of small packages
[[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, http://medlineplus.gov/householdproducts.html, Document ID 0059).
Thus, aggregate exposure information is available to the public for
many chemicals where occupational, consumer, and environmental
exposures are possible, as intended by the GHS.
An additional international activity impacting the HCS is OSHA's
participation in the RCC. The RCC was established in 2011 to promote
economic growth, job creation, and other benefits through increased
regulatory coordination and transparency between the U.S. and Canada
(US EOP, 2011, Document ID 0057). In June 2018, U.S.-Canada RCC
principles were reaffirmed through a memorandum of understanding
between the U.S. Office of Information and Regulatory Affairs (OIRA)
within the White House Office of Management and Budget and the Treasury
Board of Canada (US-Canada MOU, 2018, Document ID 0199). Since the
RCC's inception, OSHA and Health Canada, Canada's corresponding
governmental agency, have developed joint guidance products and
consulted on respective regulatory activities. In keeping with the
RCC's goal of regulatory cooperation, OSHA is proposing several updates
to the HCS that will align with Canada's Hazardous Products Regulations
(HPR), such as changes to exemptions for labeling small containers and
using prescribed concentration ranges when claiming trade secrets
(Health Canada, 2015, Document ID 0051).
B. Stakeholder Engagement
Since updating the HCS in 2012, OSHA has engaged stakeholders in
various ways in order to keep them apprised of changes to the GHS that
may have an impact on future updates to the HCS, as well as to gather
information about stakeholders' experience implementing the standard.
For example, in November 2016, OSHA convened a meeting (International/
Globally Harmonized System (GHS), Docket No. OSHA-2016-0005) to inform
the public that OSHA was beginning rulemaking efforts to maintain
alignment of the HCS with more recent revisions of the GHS. Meeting
attendees discussed topics and issues that OSHA should consider during
the rulemaking. In addition, attendees provided suggestions as to the
types of publications (such as guidance products) that would be helpful
in complying with the standard and the topics they would like OSHA to
address in future compliance assistance materials.
OSHA has also engaged stakeholders through Interagency Group public
meetings, prior to each UNSCEGHS Session, to discuss the issues and
proposals being presented at the UN. During this forum, stakeholders
have the opportunity to provide comments or voice concerns regarding
the various proposals under discussion. Stakeholders are also able to
provide comments on these proposals in writing via OSHA's docket for
International/Globally Harmonized System (GHS) (Docket No. OSHA-2016-
0005). The Interagency Group considers the comments and information
gathered at these public meetings and in the docket when developing the
United States' position on issues before the UN.
Additionally, in December 2018, the RCC held a stakeholder forum in
Washington, DC. The purpose of the forum was to conduct senior-level
discussions to proactively identify and discuss challenges,
opportunities, and lessons learned regarding Canada-U.S, regulatory
cooperation'' (US EOP, 2018, Document ID 0252). OSHA led the session
regarding chemicals management and workplace chemicals.
C. OSHA Guidance Products, Letters of Interpretation, and Directives
Since OSHA's publication of the HCS update in 2012, the agency has
published guidance documents, issued letters of interpretation (LOI),
and implemented an enforcement directive. To see the guidance
documents, please go to OSHA's web page at: https://www.osha.gov/dsg/hazcom/guidance.html. OSHA will continue to develop guidance documents
to assist employers and employees with their understanding of the HCS
and is seeking comments in this NPRM on types of guidance documents
that the public may find useful to understand the updated HCS. Any
guidance provided will accord with the Department's regulation at 29
CFR part 89, with a primary aim of providing helpful, plain language
explanations.
OSHA has issued several letters of interpretation (LOI) in response
to questions from the regulated community. These LOI provide
clarification on provisions in the 2012 update to the HCS, and how they
apply in particular circumstances. Some of the major issues covered in
the LOI include the labeling of small containers, the labeling of
chemicals released for shipment, and the use of concentration ranges
for trade secrets. OSHA's LOI on the HCS may be found at https://www.osha.gov/laws-regs/standardinterpretations/standardnumber/1910/1910.1200%20-%20Index/result. In addition, the agency has published a
directive that provides guidance to enforcement compliance officers
intended to ensure uniform enforcement of the standard by the OSHA
field offices (CPL 02-02-079, OSHA, 2015, Document ID 0007; https://www.osha.gov/OshDoc/Directive_pdf/CPL_02-02-079.pdf). Several of the
updates in this proposal would codify specific elements of the
enforcement guidance the agency has already
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provided in the LOI and the directive (see Section XV: Summary and
Explanation for Regulatory Text, Appendix B and Appendix D).
IV. Need and Support for the Proposed Modifications to the Hazard
Communication Standard
The HCS is the cornerstone of OSHA's risk mitigation strategy for
controlling hazardous chemicals in the workplace. The importance of
hazard communication in general and the HCS specifically have been well
established over the past few decades, ever since OSHA first
established the HCS in 1983 as a worker's ``right to know'' standard
(OSHA Publication 3021--Workers' Rights, 2017). However, even prior to
OSHA's promulgation of the HCS, there was recognition that workers
needed to know the hazards encountered in the workplace and the
importance of communicating, classifying, and training how to address,
those hazards. The foundational goal of the HCS is to identify,
understand, and communicate the hazards associated with exposure to
chemicals before workers experience chronic exposure to those hazards.
OSHA first established the need for the HCS in the 1983 standard
(48 FR 53282-53284) and most recently reiterated the need for the
standard in 2012, when OSHA adopted the GHS hazard communication
framework (77 FR 17584-17600). The 2012 HCS emphasized the need for
improved quality, consistency, and comprehensibility of information
provided to workers. The improved information mandated by the current
HCS enables employers and workers to further reduce risks associated
with chemical hazards by enabling them to identify and determine the
hazards and by providing a method to indicate the severity of the
relevant hazards. The HCS, as updated in 2012, also mandates
information on proper storage and handling and other information on
risk mitigation and management. Numerous studies examined in the final
rulemaking for the 2012 HCS supported the need for a hazard
communication standard that was focused on ensuring the
comprehensibility of the conveyed information (77 FR 17584-17585).
OSHA is now proposing additional changes to the HCS that will serve
three primary purposes: (1) Maintaining alignment with the GHS and
ensuring that the standard reflects the current state of science and
knowledge on relevant topics; (2) cooperating with international
trading partners and other Federal agencies; and (3) responding to
stakeholder experiences implementing current HCS requirements. The
proposed changes include clarifying the purpose and scope of the
standard, adding definitions, codifying enforcement policies currently
in OSHA's compliance directive, clarifying requirements related to the
transport of hazardous chemicals, adding labeling provisions for small
containers, and adopting new requirements related to preparation of
SDSs and new provisions related to claiming concentration ranges as
trade secrets. The agency believes that the changes proposed in this
NPRM will further improve the comprehensibility and utility of the
standard and allow the HCS to keep up with advances in relevant science
and technology, thereby better protecting worker health and safety.
A. Maintaining Alignment With the GHS and Ensuring That the Standard
Reflects the Current State of Science and Knowledge on Relevant Topics
Periodic updates to the HCS are needed to maintain pace with the
general advancement of science, technology, and our understanding of
the processes involved in effective communication. As stated in the
2008 ILO report, ``Continuous improvement of occupational safety and
health must be promoted. This is necessary to ensure that national
laws, regulations, and technical standards to prevent occupational
injuries, disease, and deaths are adapted periodically to social,
technical, and scientific progress and other changes in the world of
work.'' (ILO, 2008, Document ID 0181). While the tools and protective
measures in place to reduce or prevent chemical-related occupational
injuries and illnesses are effective, such tools and systems become
less effective as time goes by and new technologies and workplace
hazards emerge. Therefore, there is a need for continual improvement in
the systems and processes designed to identify, communicate about, and
reduce workplace exposures to chemical hazards. OSHA has always
intended for the HCS to be updated periodically to reflect these
advancements, as is the GHS (for further discussion see Section XIV,
Issues and Options).\3\
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\3\ The ILO and the World Health Organization (WHO) have also
adopted an evergreen approach to workplace hazard communication
(i.e., an approach that ensures systems for hazard communication
remain relevant and up-to-date). The ILO and WHO produce
international chemical safety cards (ICSC) and maintain a database
of approximately 500 data sheets designed to provide safety and
health information on hazardous chemicals in a format consistent
with the GHS. While not exactly like SDSs, ICSCs use GHS
precautionary statements to convey safety and health information
about workplace chemicals in a consistent, internationally-
accessible manner. With participation by experts from government
agencies around the world, including the U.S. (CDC/NIOSH), Canada
(Health Canada and Environment Canada), and the European Commission
(ECHA), ICSCs are prepared and periodically updated to account for
the most recent scientific developments. Due to the robust process
of preparation and peer-review, the ICSCs are considered
authoritative in nature and a significant asset for workers and
health professionals across the globe, including in the United
States (ILO, 2019, Document ID 0069).
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The proposed changes to the HCS will result in better alignment
between the standard and the continually-evolving GHS. The first
edition of the UN GHS, adopted in December 2002 and published in 2003,
implemented the 16-section format for SDSs that is now standard across
much of the globe. As information has improved, the GHS has updated the
form and content of SDSs \4\ to improve readability, minimize
redundancies, and ensure hazards are communicated appropriately (UN
GHS, 2017, Document ID 0060; ANS revises standard, 2005, Document ID
0237).
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\4\ SDSs, as adopted by the HCS, are intended to provide
comprehensive information about a substance or mixture for use in
the workplace, including identification of the substance or mixture;
hazard identification; composition/ingredient information; first aid
measures; fire-fighting measures; accidental release measures;
handling and storage; exposure controls/personal protective
measures; physical and chemical properties; stability and
reactivity; toxicological information; ecological information;
disposal considerations; transport information; regulatory
information; and other information that may be relevant to the
workplace (e.g., date the SDS was prepared, key literature
references, and sources of data used to prepare the SDS).
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Information OSHA has collected since publication of the 2012
updates to the HCS indicates that aligning the HCS with the GHS has had
a positive impact. Data from published studies indicate that the hazard
communication approach taken in the 2012 HCS has been effective, when
implemented appropriately, in enabling workers to understand, avoid,
and mitigate exposures to hazardous chemicals in the workplace
(Bechtoldt, 2014, Document ID 0061; Elliott, 2016, Document ID 0119).
Industry representatives have indicated that workers responded
positively to training on pictograms and hazard statements because it
provided an opportunity to address distinctions between acute toxicity
and chronic health effects (Bechtold, 2014, Document ID 0061). In
reference to SDSs, one industry representative stated that ``[b]ecause
the standardized hazard statements and classifications are so precisely
disclosed, it'll be a lot easier for industrial hygienists to identify
the more hazardous chemicals, decide where they may need to take
action, and compare the hazards of one product versus another.''
(Bechtold, 2014,
[[Page 9582]]
Document ID 0061; Elliot, 2016, Document ID 0119). Consistent labeling
requirements have also enabled employers to identify the most hazardous
materials in the workplace, understand more about the health effects of
these chemicals, and address which hazardous chemicals they may want to
replace with safer alternatives (Bechtold, 2014, Document ID 0061).
Several studies published since the 2012 HCS adopted the 16-section
SDS format indicate that the new format improves comprehension in the
workplace (Elliott, 2016, Document ID 0119; Boelhouwer, 2013, Document
ID 0107). However, other recent studies have shown that the system can
still be improved upon. Multiple studies in various industries have
demonstrated that while comprehension has improved, many SDSs lack
information vital to worker protections. Problems include insufficient
information on the identification of substances/mixtures; inadequate
hazard identification and classification information (e.g., missing
information on carcinogens and sensitizers, incorrect chemical
classifications); lack of precautionary statements on safe handling;
missing information on exposure controls/personal protective equipment;
and missing toxicological information (Jang, 2019, Document ID 0110;
Allen, 2017, Document ID 0117; DiMare, 2017, Document ID 0118; Tsai,
2016, Document ID 0116; Friis, 2015, Document ID 0120; Saito, 2015,
Document ID 0191; Suleiman, 2014, Document ID 0192; Lee, 2012, Document
ID 0070). A 2014 study concluded that the contents of the SDSs
evaluated were generic and incomplete, lacking important safety
measures and health information (Suleiman, 2014, Document ID 0192). A
study on mixtures found that information on individual ingredients
within mixtures was sometimes completely missing and that information
on hazard characterization and classification was ambiguous and almost
entirely incorrect (LeBouf, 2019, Document ID 0183). Furthermore, a
2012 study conducted by NIOSH found that SDSs for certain classes of
chemicals lacked sufficient information to communicate the appropriate
hazards and remedies related to engineered nanomaterials (Eastlake,
2012, Document ID 0063). A follow-up NIOSH study found some improvement
in SDS preparation since implementation of the 2012 HCS; however, the
study also found that there are still serious deficiencies in providing
adequate information on the inherent health and safety hazards of
engineered nanomaterials, including handling and storage (Hodson, 2019,
Document ID 0067).
Inadequate information on the chemical hazards and risk management
practices required on SDSs can lead to overexposure to chemical hazards
and puts workers at risk. The studies described above demonstrate the
need for ongoing review and refinement to make certain the standard is
addressing comprehensibility issues and staying relevant with current
occupational safety and health tools, science, and technology. Using
information gained through the experience of global stakeholders, the
GHS is updated with revisions and improvements every two years. These
changes have been outlined in brief in Section III (Events Leading to
the Proposed Modifications to the Hazard Communication Standard) of
this NPRM. The proposed updates to appendix D, which are based in part
on recent revisions to the GHS, seek, among other things, to remedy the
issues that have been identified by clarifying the information needed
in the SDS. For example, the change in section 9 (physical
characteristics to include particle characteristics) will identify
exposure issues that are not addressed by the current format. This
should, among other things, improve the hazard information required for
nanomaterials.
Furthermore, the GHS has been updated to reflect the development of
non-animal test methods for use in hazard determination and
classification. The development of these test methods led to updates in
Chapter 3.2 on skin corrosion/irritation that incorporated new in vitro
test methods, and computational and in silico techniques, to classify
chemicals for this category of hazard (UN GHS, 2018, Document ID 0242).
And techniques and processes developed in the behavioral sciences have
led to the development of more effective communication practices for
occupational safety and health purposes (NIOSH, 2019, Document ID
0126).\5\ Studies evaluating the effectiveness of precautionary
statements and pictograms used in the GHS have led to their evolution
and continued revisions (Fagotto, 2003, Document ID 0125; Ta, 2010,
Document ID 0115; Ta, 2011, Document ID 0194; Chan, 2017, Document ID
0017).
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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).
---------------------------------------------------------------------------
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.
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TP16FE21.001
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[GRAPHIC] [TIFF OMITTED] TP16FE21.002
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BILLING CODE 4510-26-C
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: http://www.reginfo.gov/public/do/PRAMain,
scroll under ``Currently Under Review'' to ``Department of Labor
(DOL)'' to view all of the DOL's ICRs, including those ICRs submitted
for proposed rulemakings. To make inquiries, or to request other
information, contact Ms. Seleda Perryman, Directorate of Standards and
Guidance, telephone (202) 693-2222.
VII. Preliminary Economic Analysis and Initial Regulatory Flexibility
Analysis
A. Introduction and Summary
Under Executive Order 12866, OMB's Office of Information and
Regulatory Affairs (OIRA) determines whether a regulatory action is
significant and, therefore, subject to the requirements of Executive
Order 12866 and OMB review. Section 3(f) of Executive Order 12866
defines a ``significant regulatory action'' as an action that is likely
to result in a rule that (1) has an annual effect on the economy of
$100 million or more, or adversely affects in a material way a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or state, local or tribal governments or
communities (also referred to as economically significant); (2) creates
serious inconsistency or otherwise interferes with an action taken or
planned by another agency; (3) materially alters the budgetary impacts
of entitlements, grants, user fees, or loan programs, or the rights and
obligations of recipients thereof; or (4) raises novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in Executive Order 12866. Upon review, OMB has
determined that this proposed rule is a significant regulatory action
(``Other Significant'') under Executive Order 12866. Pursuant to the
Congressional Review Act (5 U.S.C. 801 et seq.), OIRA designated that
this rule is not a ``major rule,'' as defined by 5 U.S.C. 804(2).
OSHA has made a preliminary determination that this action is not
an economically significant regulatory action under section 3(f)(1) of
Executive Order 12866 because it is not likely to have an annual effect
on the economy of $100 million or more. This proposed rule is expected
to be an Executive Order 13771 deregulatory action. Details on the
estimated cost-savings of this rule can be found in the economic
analysis below. Executive Order 13563 directs agencies to adopt a
regulation only upon a reasoned determination that its benefits justify
its costs; tailor the regulation to impose the least burden on society,
consistent with obtaining the regulatory objectives; and in choosing
among alternative regulatory approaches, select those approaches that
maximize net benefits. Executive Order 13563 recognizes that some
benefits are difficult to quantify and provides that, where appropriate
and permitted by law, agencies may consider and discuss qualitatively
values that are difficult or impossible to quantify, including equity,
human dignity, fairness, and distributive impacts.
OSHA has prepared this Preliminary Economic Analysis (PEA),
including a Preliminary Regulatory Flexibility Analysis Certification,
for the proposed modifications to the HCS. Supporting materials
prepared by OSHA (including spreadsheets) are available in the public
docket for this rulemaking, Docket ID OSHA-2019-0001, through
www.regulations.gov. OSHA invites comment on any aspects of this PEA.
In this PEA, OSHA estimates that the proposed amendments to the HCS
would result in annualized net cost savings of $26.8 million at a 7
percent discount rate. Annualized at a 3 percent discount rate, OSHA
estimates that the proposed amendments to the rule would lead to net
cost savings of $27.5 million per year. Under a perpetual time horizon
to allow for cost comparisons under Executive Order 13771, OSHA
estimates that at a discount rate of 7 percent the net cost savings of
the proposed amendments to the HCS would be $19.6 million per year in
2016 dollars.\8\ OSHA expects that the proposed revisions to the HCS
would also result in modest improvements in worker health and safety
above those already being achieved under the current HCS, but the
agency is unable to quantify the magnitude of these benefits.
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\8\ This calculation (a) converts the costs and cost savings of
the rule from 2019 dollars to 2016 dollars using the BEA (2020)
implicit price deflator for Gross Domestic Product, and (b)
discounts the first year costs by five years, to reflect the five
years between 2016 and 2021, the scheduled year of publication of
this NPRM. For further details, see Document ID 0049, tab Tables,
E.O. 13771 Summary Table.
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B. Need for Regulation
Employees in work environments covered by OSHA's HCS are exposed to
a variety of significant hazards associated with chemicals used in the
workplace that can and do cause serious injury, illness, and death. The
HCS serves to ensure that both employers and employees are provided the
information they need about these chemical hazards. The current HCS
contains a set of requirements for chemical products, including
mandatory hazard classification, labeling requirements, provisions for
providing detailed information (in SDSs), and label updating
requirements. These requirements are based on Revision 3 of the GHS,
which was adopted by the UN Committee and Sub-Committee of Experts on
the GHS in December 2008.
OSHA has preliminarily determined that the proposed revisions to
the HCS would make employers' hazard communication programs more
worker-protective, efficient, and effective through standardizing
practices nationally and internationally. In addition, aligning with
the GHS Rev. 7 would continue to facilitate
[[Page 9591]]
international trade, as a number of U.S. trading partners are also
preparing to align with the GHS Rev. 7.
The proposed revisions to the HCS include the following notable
changes to improve the U.S. hazard communication system:
Maintain alignment with the GHS
[cir] Adding classification categories for aerosols, desensitized
explosives, and flammable gases; and
[cir] Updating select hazard and precautionary statements for
clearer and more precise hazard information.
Address issues identified in implementing the HCS 2012
[cir] Updating labeling requirements for small containers; and
[cir] Updating labeling requirements for packaged containers that
have been released for shipment.
As discussed in Section F of this PEA, the estimated costs and cost
savings resulting from the proposed revisions to the HCS consist of
five main categories: (1) The cost of reclassifying affected chemicals
and revising the corresponding SDSs and labels to achieve consistency
with the reclassification (per proposed changes to appendix B), and the
cost of revising SDSs and labels to conform with new precautionary
statements and other new mandatory language in the appendices to the
HCS (per proposed changes to appendices C and D); (2) the cost of
management familiarization and other management-related costs
(associated with all of the proposed revisions to the standard); (3)
the cost of training employees as necessitated by the proposed changes
to the HCS (see existing 29 CFR 1910.1200(h)(1)); (4) the cost savings
resulting from the new released-for-shipment provision (proposed
revisions to 29 CFR 1910.1200(f)(11)); and (5) the cost savings from
limiting labeling requirements for certain very small containers
(proposed 29 CFR 1910.1200(f)(12)). The first three categories are
considered to be one-time costs and the last two categories are cost
savings that would accrue to employers annually.
The proposed changes to the HCS would maintain the uniformity of
hazard information with the GHS and would, accordingly, serve to
improve the efficiency and effectiveness of the existing hazard
communication system in the U.S., ensure that updated and advanced HCS
methods are recognized, and reduce unnecessary barriers to trade. In
short, the GHS is a ``uniformity standard'' for the presentation of
hazard information (Hemenway, 1975, Document ID 0050). Much like other
uniformity standards, such as driving on the right side of the road (in
the U.S.), screw threads for fire hose connectors, ``handshake''
protocols for communication between computers, and, for that matter,
language, the GHS provides significant efficiencies and economies.\9\
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\9\ A specification standard, such as an engineering standard,
would spell out, in detail, the equipment or technology that must be
used to achieve compliance. The usual rationale for a specification
standard is that compliance would be difficult to verify under a
performance standard; hence, a specification standard would better
protect employees against the risk in question. A specification
standard would generally not provide the efficiencies or economies
(such as easier, less expensive training on uniform pictograms and a
uniform SDS format made possible by the GHS) to the regulated
community that a uniformity standard would. On the contrary, a
specification standard could impose additional costs on some firms
that may be able to effectively protect workers using a cheaper
alternative approach if such flexibility were permitted.
It is also worth noting that, for uniformity standards with
technological implications, the benefits of reduced information
costs, economies of uniformity, and facilitation of exchange may
need to be weighed against possible losses of flexibility,
experimentation, and innovation. However, because the GHS is limited
to the presentation of hazard information and does not involve other
than incidental technological or strategic considerations, the
possible costs of uniformity here would be minuscule.
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Since publication of the update to the HCS in 2012, there continues
to be movement by U.S. trading partners toward maintaining
standardization, consistent with the revisions in the GHS. However,
OSHA does not believe that full and comprehensive standardization in
accordance with the GHS, or the goal of harmonizing the U.S. system
with the international one, can be achieved voluntarily in the absence
of regulation.
First, the market alone will not ensure alignment with the GHS Rev.
7. In some cases (e.g., aerosols, desensitized explosives), the GHS
Rev. 7 contains different hazard classes or classification criteria
than the current HCS, and it would be impermissible for a manufacturer
to comply with the GHS Rev. 7 rather than the criteria in the existing
HCS. Moreover, making compliance with the latest revision of the GHS
optional undermines the goal of harmonizing classification criteria and
label elements. Second, while the costs of creating SDSs and labels are
borne directly by the chemical producers, maintaining alignment with
the GHS benefits the users of hazardous chemicals. These users include
employers who are direct customers of chemical manufacturers, employees
who use or are exposed to workplace chemicals, and emergency responders
who typically have no market relationship with the chemical producers.
Even if market forces could ensure the socially optimal approach to
SDSs between chemical manufacturers and their customers, there are
limited market forces at work between the chemical manufacturer and two
key sets of users--the employees and the emergency response community.
Therefore, the benefits achieved by maintaining alignment with the GHS
are unlikely to be obtained in the private market without regulation.
OSHA recognizes that there will be some market pressure to align
with the GHS Rev. 7 as its adoption expands internationally.\10\ Some
firms in the U.S. may think that they have no need to follow the GHS
because they do not ship their products internationally. These firms
may not realize the extent to which they are involved in international
trade. There are probably few companies that have products that are
never involved in international trade or that never import chemical
products requiring hazard information.\11\ Nonetheless, even the small
percentage of U.S. companies that only conduct business domestically
are required to identify and communicate hazards to workers under the
HCS. Many chemical producers ship their products to distributors and
are unaware of where their products are ultimately used. These
distributors might well put pressure on their suppliers to maintain
compliance with the GHS. Further, small companies sell chemicals to
larger companies. The larger companies may use those chemicals to make
other products that are exported. These larger companies might also
pressure their small-firm suppliers to align with the GHS.
Nevertheless, relying solely on market pressures would surely involve a
long transition period, with attendant
[[Page 9592]]
losses in worker protection and production efficiencies, and it is
unlikely that the market alone will ensure full alignment with the GHS
for reasons described above.
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\10\ See https://www.unece.org/fileadmin/DAM/trans/doc/2018/dgac10c4/ST-SG-AC10-C4-70e.pdf, pp. 12-13 (UN GHS, 2018, Document ID
0040).
\11\ According to the U.S. International Trade Commission, U.S.
imports of chemicals and related products increased 23 percent from
2015 ($260.4 billion) to 2019 ($320.1 billion); and U.S. exports of
chemicals and related products increased 7 percent from 2015 ($227.7
billion) to 2019 ($243.7 billion). See https://usitc.gov/research_and_analysis/trade_shifts_2019/chemicals.htm, accessed
October 2, 2020 (Document ID 0234). The International Trade
Administration reported that the U.S. chemical industry accounted
for 18 percent of global chemical shipments. See https://www.selectusa.gov/chemical-industry-united-states, accessed October
2, 2020 (Document ID 0236). The American Chemistry Council reported
that in 2019, total U.S. chemical exports accounted for 10 percent
of all U.S. goods exports and 10 percent of all global chemical
exports. See https://www.americanchemistry.com/Policy/Trade/US-Chemicals-Trade-by-the-Numbers.pdf, accessed October 2, 2020
(Document ID 0235).
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The proposed changes to the HCS would involve costs and cost
savings mainly for manufacturers and importers. Manufacturers and
importers of chemicals would also achieve benefits--in part because
they themselves benefit as both producers and users, and in part as a
result of foreign trade benefits. Some manufacturers may not obtain
trade benefits unless they engage in chemical export. International
harmonization of hazard communication requirements may also make it
easier for small companies to engage in international trade if they so
desire (see additional discussion below in VII.D. Health and Safety
Benefits and Unquantified Positive Economic Effects).
Of more significance to the concerns of the OSH Act, the proposed
changes would also provide health benefits from improved hazard
classification and communication; although unquantified in this
proposal, these benefits would include reductions in worker illnesses,
injuries, and fatalities (see additional discussion below in VII.D.
Health and Safety Benefits and Unquantified Positive Economic Effects).
Because many of the health and safety benefits and cost savings
described in this analysis require uniformity and are dispersed among a
network of producers and users, only some of which have direct market
relationships with each other, OSHA believes maintaining a single,
uniform standard can best achieve the full benefits available from a
hazard communications system.
C. Profile of Affected Industries, Establishments, and Employees
The proposed modifications to the standard include revised criteria
for classification of certain health and physical hazards; revised
labeling provisions for small containers and packages that have been
released for shipment; revised trade secret disclosure requirements;
updates to certain aspects of SDSs and precautionary statements; and
related revisions to definitions of terms used in the standard.
In this section, OSHA presents a preliminary profile of industries
affected by this proposal to revise the HCS. The profile data in this
section are based upon the 2012 HCS final economic analysis (FEA),
updated in this PEA with the most recent data available.
As a first step, OSHA identifies the North American Industry
Classification System (NAICS) industries affected by the proposed
changes to the HCS. Next, OSHA provides statistical information on the
affected industries, including the number of affected entities and
establishments; the number of workers whose exposure to the chemicals
subject to the HCS could result in injury, illness, or death
(``affected relevant employees''); and the average revenues and profits
for affected entities and establishments by six-digit NAICS
industry.\12\ This information is provided for each affected industry
as a whole, as well as for small entities, as defined by the Small
Business Administration (SBA), and for ``very small'' entities, defined
by OSHA as those with fewer than 20 employees, in each affected
industry (U.S. Census Bureau, 2020a, Document ID 0231; U.S. Census
Bureau, 2020b, Document ID 0232).
---------------------------------------------------------------------------
\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.
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\18\ Technical and analytical support for this preliminary
economic analysis was provided by Eastern Research Group, Inc. under
Contract No. DOL-OPS-16-D-0012.
\19\ This methodology was not challenged by commenters during
the rulemaking that resulted in the 2012 final rule.
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OSHA's estimate of the number of labels per NAICS industry is
constructed using the same methodology developed in the 2012 HCS final
rule (Document ID 0005, pp. 17634-17643), but with more recent data.
The steps in the analysis, elaborated on below, can be summarized as
follows:
Begin with data on shipment weight by commodity code and
shipment weight class.
Estimate the average weight per container for containers
of various sizes.
Allocate the tons shipped in each shipment weight class
for certain sizes of containers.
Divide the tons shipped by the average container weight to
estimate total containers.
Multiply the containers by the average number of labels
per container to estimate total labels.
Allot the labels among NAICS codes using receipts data.
The label analysis begins with the U.S. Census Bureau and the U.S.
Department of Transportation's jointly-produced Commodity Flow Survey
(CFS) (U.S. Census Bureau, 2014a, Document ID 0024) data on shipment
characteristics by commodity and shipment weight. This dataset includes
the number of tons shipped for a range of shipment weight classes by
Standard Classification of Transported Goods (SCTG) code. The number of
tons is converted to pounds, and limited to hazardous non-consumer
products (i.e., those that would have the HCS labeling).\20\ This
estimate is used in conjunction with another CFS dataset (U.S. Census
Bureau, 2014b, Document ID 0030) that has shipment data by NAICS
industry (but not by shipment weight) to divide the detailed shipment
weight data into shipments coming from manufacturers and distributors.
---------------------------------------------------------------------------
\20\ The estimated percentages for the transported goods
identified as hazardous non-consumer products were presented in the
2012 HCS FEA cost model. See ERG/OSHA, 2012, Document ID 0029). At
the time OSHA developed this PEA, the final 2017 CFS data was not
yet available. Therefore, 2012 CFS data was the most recent
information available. OSHA requests public comments on the
estimated percentages for the transported goods identified as
hazardous non-consumer products in this preliminary profile.
---------------------------------------------------------------------------
The next step in the methodology estimated the representative
weight per container for a variety of types of containers (ranging in
size from a 3-milliliter vial to a rail car) and substances (such as
antifreeze, diesel fuel, paint). Using representative substances, OSHA
estimated the shipment weight for one container of each size as
Shipment Weight = (Product Weight per gallon x Container Capacity) +
Container Weight. Because of a lack of available data establishing the
percentage of products shipped by container type (i.e., the breakdown
of the types of products shipped by each container type), the
calculation for each product and container type relied on professional
judgment (by OSHA and its economic contractor, ERG) to select a
``typical'' product weight per gallon and container weight for each
container type. Next, the analysis estimated shipment weight per
container by multiplying the average product weight per gallon times
the number of gallons per container, plus the container weight.
To convert the CFS data on tons (or pounds) shipped by container
size into a number of containers, the analysis estimated the percentage
of each shipment class likely to be shipped in certain sizes of
containers. Shipments of lower weights are generally estimated to be
shipped in smaller containers, and vice versa. Then the total non-
consumer hazardous pounds shipped (from the CFS data) was multiplied by
the estimated percentage shipped in each container type to yield the
number of non-consumer hazardous pounds in each container type.
Finally, the non-consumer hazardous pounds in each container type was
divided by the average weight per container type to yield an estimate
of the total number of containers.
To estimate the number of labels that would be used on these
containers, the analysis first estimated the average number of labels
on a single container for each container size (from Table VII-4 above).
As previously noted, these estimates account for the fact that some
containers have outer packaging that would require an additional label
under this proposed rule (e.g., kits containing containers less than
100 ml where tags and fold out labels are infeasible) or are shipped
with several containers grouped into a single outer container with a
label. This average number of labels per container for each shipment
size class was then multiplied by the number of containers to estimate
the total number of labels.
The final step in the analysis was to allocate the number of labels
shipped from SCTG codes to NAICS codes. The NAICS-to-SCTG mapping was
adapted from the mapping used in the FEA in support of the 2012 HCS
final rule analysis, but with NAICS categories updated from 2007 to
2017 categories. U.S. Census (2020a; 2020b) Statistics of U.S.
Businesses data was used to estimate each NAICS industry's share of
total receipts for the SCTG code with which it corresponds, and then
the number of labels in each SCTG was allocated proportionally. (This
calculation was performed separately for shipments from manufacturers
and from distributors for purposes of estimating cost savings due to
the proposed released-for-shipment provision in paragraph (f)(11)).
This resulted in the estimated number of labels shown in Column 3 of
Table VII-5.\21\
---------------------------------------------------------------------------
\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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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).
---------------------------------------------------------------------------
\28\ OSHA annualized costs for this proposed rule over a 10-year
period in accordance with Executive Order 13563, which directs
agencies ``to use the best available techniques to quantify
anticipated present and future benefits and costs as accurately as
possible.'' In addition, OMB Circular A-4 states that analysis
should include all future costs and benefits using a ``rule of
reason'' to consider for how long it can reasonably predict the
future and limit its analysis to this time period. The 10-year
annualization period is the one OSHA has traditionally used in
rulemakings. Note, however, that OSHA used a 20-year annualization
period for the 2012 HCS final rule (77 FR 17625), but that was
because of the 5-year phase-in of some provisions. This proposed
rule does not have any lengthy phase-in provisions, supporting
OSHA's decision to use a 10-year annualization period for this PEA.
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For the purpose of calculating loaded wage rates, OSHA did not
include an overhead labor cost in the FEA in support of the 2012 HCS
final standard. The Department of Labor has since determined that it is
appropriate, in some circumstances, to account for overhead expenses as
part of the methodology used to estimate the costs and economic impacts
of OSHA regulations. For this PEA, in addition to applying fringe
benefits to hourly (``base'') wages, OSHA also applied an overhead rate
when estimating the marginal cost of labor in its primary cost
calculation.
Overhead costs are indirect expenses that cannot be tied to
producing a specific product or service. Common examples include rent,
utilities, and office equipment; however, there is no general consensus
on the cost elements that fit the definition of overhead in the context
of occupational safety and health. The lack of a common definition has
led to a wide range of overhead estimates. Consequently, the treatment
of overhead costs needs to be case-specific. For this PEA, OSHA has
adopted an overhead rate of 17 percent of base wages, which is
consistent with the overhead rate and methodology used for (1)
sensitivity analyses in the FEA in support of the 2017 final rule
delaying the deadline for submission of OSHA Form 300A data (82 FR
55761, 55765 (Nov. 24, 2017)); and (2) the FEA in support of OSHA's
2016 final standard on Occupational Exposure to Respirable Crystalline
Silica (81 FR 16285, 16488-16492 (March 25, 2016)).\29\
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\29\ This methodology was modeled after an approach used by the
Environmental Protection Agency. More information on this approach
can be found at U.S. Environmental Protection Agency, ``Wage Rates
for Economic Analyses of the Toxics Release Inventory Program,''
June 10, 2002 (Ex. 2066) (Document ID 0046). This analysis itself
was based on a survey of several large chemical manufacturing
plants: Heiden Associates, Final Report: A Study of Industry
Compliance Costs under the Final Comprehensive Assessment
Information Rule, prepared for the Chemical Manufacturers
Association, December 14, 1989 (Ex. 2065) (Document ID 0048).
---------------------------------------------------------------------------
To calculate the total labor cost for an occupational category,
OSHA added together three components: Base wage + fringe benefits
(derived as 45.8 percent of the base wage) \30\ + applicable overhead
costs (derived as 17 percent of the base wage). For example, the median
hourly wage of an Occupational Health and Safety Specialist is $35.63.
Applying a fringe markup of 45.8 percent (applied to the base wage) and
an overhead rate of 17 percent (applied to the base wage) yields a
fully-loaded hourly wage of $ $58.00 ($35.63 x .458 = $16.32; $35.63 x
0.17 = $6.11; $35.63 + $16.32 + $6.11 = $58.00). Note that, for this
labor category, the fringe markup is equal to 28.13 percent of the
fully-loaded hourly wage and that the overhead rate is equal to 10.53
percent of the fully-loaded hourly wage. Using this methodology, OSHA
calculated the fully-loaded labor cost for four occupational
categories: (1) Manager, Standard Occupational Classification (SOC)
code 11-0000, $82.70; (2) Logistics Personnel, SOC code 13-1081,
$58.51; (3) Production Worker, SOC code 51-0000, $28.18; and (4)
Occupational Health and Safety Specialist, SOC code 19-5011, $58.00.
(For further details, see Document ID 0049, tab ``Wages''.)
---------------------------------------------------------------------------
\30\ In June of 2019, BLS reported: ``Employer costs for
employee compensation for civilian workers averaged $36.77 per hour
worked in March 2019 . . . Wages and salaries cost employers $25.22
while benefit costs were $11.55.'' The fringe markup of 31.4 percent
of total compensation ($11.55/$36.77) is equivalent to a benefits
markup of 45.8 percent in relation to the base wage ($11.55/$25.22).
(BLS, 2019, Document ID 0224).
---------------------------------------------------------------------------
Table VII-12 shows the estimated annualized compliance costs and
cost savings by cost category and by industry sector. All costs and
cost savings are reported in 2019 dollars. As shown in Table VII-12,
the total annualized net cost savings of compliance with the proposed
rulemaking is estimated to be $26.8 million--consisting of about $4.4
million of annualized costs and $31.1 million of annual cost savings.
Note that where tables in this PEA report estimated annualized costs,
as in Table VII-12, cost savings appear as a negative number.
As shown by the three-digit NAICS Subsectors 325 (for Chemical
Manufacturing) and 424 (for Merchant Wholesalers, Nondurable Goods) in
Table VII-12, most of the estimated compliance costs and cost savings
associated with the proposed rule would be incurred or realized by the
chemical manufacturing industry and its distributors. However, the
table also shows that familiarization costs would be spread across most
manufacturing and wholesale industries in the U.S. economy subject to
OSHA's jurisdiction, reflecting the fact that employee exposures to
hazardous chemicals occur in many industry sectors.
OSHA expects that all compliance costs would be incurred in the
first year, as the proposed rule would incorporate a one-year
transition period into the compliance schedule for the standard.
Specifically, for purposes of estimating the annualized compliance
costs, OSHA assumed that the compliance costs associated with chemical
reclassification, employee training, and management familiarization
would be incurred in the first year following the effective date of the
proposed revisions to the HCS.
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BILLING CODE 4510-26-C
Estimation of Compliance Costs and Cost Savings
The remainder of his section explains how OSHA calculated the
estimated compliance costs and cost savings arising from the proposed
rule by describing the data and methodology used.
The major elements of the proposed revisions to the HCS that
involve compliance costs or cost savings are (1) the cost of revising
SDSs and labels for select hazardous chemicals to reflect chemical
reclassifications (per proposed changes to appendix B) and to conform
to language criteria in precautionary statements and other mandatory
language (per proposed changes to appendices C and D); (2) the cost of
management familiarization and other management-related costs necessary
to ensure compliance with the revised standard (associated with all of
the proposed revisions to the standard); (3) the cost of training
employees as necessitated by the proposed changes to the HCS (see
existing 29 CFR 1910.1200(h)(1)); (4) cost savings from the new
released-for-shipment provision (proposed revisions to 29 CFR
1910.1200(f)(11)); and (5) cost savings from limiting labeling
requirements for certain very small containers (proposed 29 CFR
1910.1200(f)(12)).
The estimated compliance costs and cost savings presented in this
analysis of the proposed revisions to the HCS are based partly on
analysis conducted in support of the 2012 HCS final rule (77 FR 17605-
17683) and partly on new analysis prepared with the assistance of
OSHA's contractor, ERG.
The estimated costs of compliance with most provisions of the
proposed rule involve wages paid for the labor hours required to
fulfill the requirements. In some cases, compliance could be achieved
by purchasing services or products in lieu of paying employees
directly. The estimated compliance costs are intended to capture the
resources required for compliance regardless of how individual
establishments may choose to achieve compliance.
With the exception of the proposed revision to the standard
addressing precautionary statements and other mandatory language, for
this cost analysis OSHA estimated a baseline compliance of zero
percent. The agency's estimate of baseline compliance for the revisions
in appendices C and D addressing precautionary statements and other
mandatory language are discussed below in the section, Revisions to
SDSs and Labels Due to Revised Precautionary Statements.
Costs Associated With Reclassifications and Revisions to Safety Data
Sheets and Labels
The proposed revisions to the HCS will not change the existing
requirement for firms that sell hazardous chemicals to employers to
provide information about the associated hazards. Information must be
presented in an SDS in the format specified in the standard, and some
information must also be presented on product labels. The proposed rule
would require affected chemical manufacturers to revise SDSs and labels
for select hazardous chemicals to reflect chemical reclassifications
(appendix B) and to conform to language criteria in precautionary
statements and other mandatory language (appendices C and D). Revisions
to SDSs and labels would be required under provisions in the existing
HCS, which require chemical manufacturers and importers to update SDSs
and labels within three months and six months, respectively, of
becoming aware of significant new information regarding the hazards of
the chemicals they produce or import (see 29 CFR 1910.1200(f)(11),
(g)(5)).
It is OSHA's understanding that chemical manufacturers and
importers periodically review, revise, and update the electronic
templates they use to create SDSs and labels. Changes are made, for
example, as information regarding specific hazards becomes available,
new information about protective measures is ascertained, or revisions
are made to product information and marketing materials. Labels and
SDSs are also produced and modified when products are first introduced
to the market or when products change. Therefore, there is a regular
cycle of change for these documents (see 77 FR 17634-17637 in the FEA
of the 2012 final rule for a discussion of factors that compel
employers to update SDSs and labels voluntarily). The proposed rule
would require limited changes to some SDSs and labels. Given the phase-
in period for the proposed changes to the standard,\31\ OSHA expects
that chemical manufacturers and importers would be able to phase in
revisions to their labels and SDSs in accordance with the normal cycle
of change, and therefore would not need to replace existing labels or
SDSs. OSHA requests comments on this preliminary assumption.
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\31\ OSHA proposes that the revisions become effective 60 days
after publication (paragraph (j)(1)) and that chemical
manufacturers, importers, and distributors evaluating substances
comply with all modified provisions within one year after the
effective date (paragraph (j)(2)). OSHA also proposes that chemical
manufacturers, importers, and distributors evaluating mixtures
comply with all modified provisions within two years after the
effective date (paragraph (j)(3)).
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OSHA has, however, estimated costs for the time it will take to
update the electronic files that will be used to generate new SDSs and
labels in accordance with the proposed revisions to the HCS. OSHA
developed cost estimates based on the methodology used in its FEA in
support of the 2012 HCS final rule (77 FR 17634-17637). The estimated
compliance costs represent the incremental costs that would be incurred
to achieve compliance with the proposed rule. These estimated costs,
shown below in Tables VII-13 and VII-14, would be in addition to the
costs that already need to be incurred to comply with applicable
requirements of the existing HCS and represent the time it would take
to identify the changes that need to be made to the relevant computer
files (i.e., the files that are used to generate SDSs and labels) and
then to make those changes.
Producers of affected chemicals already have an obligation, under
the existing HCS, to ensure that the information provided in their SDSs
and labels is accurate and current (29 CFR 1910.1200(f)(2) and (g)(5)).
They also are generally required to revise SDSs and labels in
accordance with new information regarding hazards that may be
associated with their products (29 CFR 1910.1200(f)(11) and (g)(5)).
For every affected product that is newly created, reformulated, mixed
with new ingredients, modified with new or different types of
additives, or has any changes made in the proportions of the
ingredients used, chemical manufacturers and importers are required,
under the existing HCS, to review the available hazard information (29
CFR 1910.1200(d)(2)), to classify the chemical in accordance with
applicable hazard criteria (29 CFR 1910.1200(d)(1)), and to develop
corresponding SDSs (29 CFR 1910.1200(g)) and labels (29 CFR
1910.1200(f)). OSHA is not estimating costs for activities already
required; rather, the agency is estimating costs for activities that
would be newly conducted in conformance with the proposed revisions to
chemical reclassifications (appendix B) and language criteria in
precautionary statements and other mandatory language (appendices C and
D).
[[Page 9637]]
Revisions to SDSs and Labels Due to Chemical Reclassification
The NAICS industries listed in Columns 1 and 2 of Table VII-13 are
those that OSHA expects would manufacture aerosols, desensitized
explosives, or flammable gases. Of course, not all chemicals covered in
these NAICS industries are aerosols, desensitized explosives, or
flammable gases. Column 3 of Table VII-13 reflects OSHA's judgment that
approximately 50 percent of the SDSs (or more specifically, 50 percent
of the electronic templates (files) that are used to produce SDSs and
labels) in these NAICS industries would be affected by the proposed
requirements for aerosols, desensitized explosives, and flammable
gases. OSHA invites public comments on its preliminary projection that
50 percent of the electronic files for SDSs and labels would be
affected in these industries.
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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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\39\ Larger employers were estimated to have greater
familiarization costs for the 2012 HCS final rule because they have
more managers.
---------------------------------------------------------------------------
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.
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\42\ OSHA has preliminarily concluded that these would be the
only training costs associated with the proposed revisions to the
HCS. The agency requests comments on this determination.
---------------------------------------------------------------------------
Similarly, even though desensitized explosives is a new hazard
classification, the explosion hazards were and are well-known and
should have been included in prior hazard training. For example, should
the water or other wetting solution dry out, an explosion could occur.
In this case, even the hazard pictogram (flames) remains unchanged.
OSHA considered whether some increase in user training might be
required for non-flammable aerosols not under pressure, since a small
portion of these may not currently be classified as either flammable
aerosols or gas under pressure; as noted in the Summary and Explanation
section for appendix B, such aerosol containers differ from pressurized
gas cylinders in terms of container characteristics and failure
mechanisms. Training for non-flammable aerosols might include their
revised classification and hazard avoidance measures (such as: Keep
away from heat, hot surfaces, sparks, open flames and other ignition
sources; no smoking; do not pierce or burn, even after use). However,
based on observation of the industry over time, OSHA believes that non-
flammable aerosols not under pressure are fairly uncommon and,
therefore, OSHA has preliminarily concluded that the total user
training time required for non-flammable aerosols not under pressure
would also be negligible. The agency requests comments on its
preliminary conclusions regarding training time for users of
reclassified chemicals.
As discussed above, under the proposed revisions to the HCS, some
chemical production employees who are covered by, and are already
trained in accordance with, the existing standard would need to receive
additional training to become familiar with the updates to SDSs and
labels for impacted aerosols, desensitized explosives, and flammable
gases. OSHA expects that the incremental training costs for these
employees to become familiar with the revisions to the HCS will be
small. In certain cases, affected employers will be able to integrate
the necessary training into existing training programs and related
methods of distributing safety and health information to employees;
those employers would not incur any meaningful additional costs.
OSHA estimates that each affected chemical manufacturing firm \43\
would need to devote 2.5 hours of a Health and Safety Specialist's time
to preparing new training under the proposed rule, and that each
affected logistics or production worker would spend 12 minutes
receiving the training. Multiplying the labor burden for each labor
category by the loaded hourly wages of $58.00 for a Health and Safety
Specialist, $58.51 for logistics personnel, and $28.18 for production
workers, results in unit costs of $145.01, $11.70, and $5.64,
respectively.
---------------------------------------------------------------------------
\43\ OSHA anticipates that, in practice, training would be
organized more efficiently at the corporate (firm) level than at the
establishment level.
---------------------------------------------------------------------------
Multiplying these unit costs by the 2,754 affected firms, 1,179
affected logistics managers, and 76,447 affected production workers
yields an undiscounted estimated one-time cost of $843,940.\44\
Annualizing this one-time cost using a 7 percent discount rate over a
10-year period results in estimated annualized costs of $120,158. The
unit values that factored into OSHA's estimate of training costs are
shown in Table VII-16. The distribution of these training costs by
NAICS code is displayed in Column 4 of Table VII-12. OSHA invites
interested parties to provide comments on these cost estimates and the
assumptions underlying them.
---------------------------------------------------------------------------
\44\ The estimated number of affected firms, logistics managers
and production workers are derived in Document ID 0049, tab
``Training''. The affected number of firms (2,754) can also be
calculated by matching the NAICS codes with training costs from
Table VI-12 with the number of affected firms in the identical NAICS
codes in Table VI-1 and multiplying by 50 percent (only 50 percent
are estimated to require training).
Table VII-16--Training Costs Associated With the Proposed Revisions to the HCS Standard
[2019 Dollars]
----------------------------------------------------------------------------------------------------------------
Health & safety
specialist hours Logistics personnel Production worker
per firm to hours per emp. to hours per emp. to Total
prepare training receive training receive training
----------------------------------------------------------------------------------------------------------------
Affected Firms........................ 2,754 ................... .................. 2,754
Employees Needing Training............ ................. 1,179 76,447 78,489
Wage.................................. $58.00 $58.51 $28.18 ............
Hours................................. 2.5 0.2 0.2 2.9
Unit Cost............................. $145.01 $11.70 $5.64 $162.35
Total One-Time Cost................... $399,289 $13,796 $430,855 $843,940
-------------------------------------------------------------------------
Total Annualized Cost (7%)........ $56,850 $1,964 $61,344 $120,158
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.
Note: Figures may not add to totals due to rounding.
[[Page 9654]]
Released for Shipment
In paragraph (f)(11) of the current HCS, chemical manufacturers,
importers, distributors, or employers who become newly aware of any
significant information regarding the hazards of a chemical must revise
the labels for the chemical within six months of becoming aware of the
new information and ensure that labels on containers of hazardous
chemicals shipped thereafter contain the new information. OSHA proposes
to modify paragraph (f)(11) such that chemicals that have been released
for shipment and are awaiting future distribution need not be
relabeled; however, the manufacturer or importer must provide an
updated label for each individual container with each shipment.
OSHA anticipates that these proposed modifications to paragraph
(f)(11) would provide cost savings to manufacturers and distributors of
certain products--those with large (and typically infrequent)
production runs and lengthy shelf lives (often five years or longer)
that, during production, are labeled, boxed, palletized, and shipped,
and then go through the distribution chain usually without the chemical
contents, packaging, or label being disturbed. In Columns 1 and 2 of
Table VII-17, OSHA has identified the six industries (four
manufacturing and two wholesale) that it expects would be impacted by
the proposed modifications to paragraph (f)(11).\45\ These are
primarily fertilizer manufacturers, paint manufacturers, and
wholesalers of related farm and paint supplies. OSHA invites comments
on whether other industries are potentially affected by this proposed
modification to paragraph (f)(11) and whether there might be other
health or economic effects of this proposed modification that OSHA has
not considered in this proposal.
---------------------------------------------------------------------------
\45\ In principle, pesticide manufacturers would also be
affected by the proposed revision to the standard, but pesticide
labeling in the United States is covered by the U.S. Environmental
Protection Agency under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.). For that reason, any
cost savings due to OSHA's proposed revisions to paragraph (f)(11)
would not apply to manufacturers in NAICS 325320: Pesticide and
other agricultural chemical manufacturing.
---------------------------------------------------------------------------
The first factor used to estimate the cost savings resulting from
the proposed changes to paragraph (f)(11) is the avoided economic loss
for affected manufacturers or wholesalers who would otherwise have to
relabel products being held in storage. To estimate the potential
economic loss avoided, OSHA relied on comments submitted to the agency
by the Council of Producers & Distributors of Agrotechnology (CPDA) on
April 21, 2017.\46\ The CPDA comments included a summary of cost
estimates associated with relabeling non-pesticide agricultural
chemical products in distribution. Those estimates were obtained from
an industry survey and were based on the following unit costs: Shipping
costs to move product out of and back into the warehouse (for off-site
package opening and replacement); relabeling space per square foot per
month; safety equipment and training per employee involved in
relabeling; labor and materials to break down pallets and shrink-wrap
and redo product packaging in new plastic bags; and labor and materials
to move liquid to new containers and dispose of old containers (CPDA,
2017, pp. 4-5, Document ID 0006).
---------------------------------------------------------------------------
\46\ Email to Maureen Ruskin of OSHA Re: Comments Supplementing
a Petition Submitted to OSHA on May 24, 2016 Requesting a Revision
of Paragraph (f)(11) of 29 CFR 1910.1200 (CPDA, 2017, Document ID
0006).
---------------------------------------------------------------------------
For OSHA's purposes, the critical costing information from CPDA is
the estimate of summary relabeling costs presented as a percentage of
the value of the products requiring relabeling. According to the CPDA
survey results, these summary costs range from 1.5 percent to 204
percent of the value of the product, depending on product type (e.g.,
liquid versus dry), container type (plastic bags, etc.), and the volume
and value of the product (CPDA, 2017, p. 8, Document ID 0006). As a
practical matter, OSHA expects that manufacturers and wholesalers would
simply discard a product rather than incur relabeling costs in excess
of the value of the product. Of course, there may be some disposal
costs for the discarded material, but there may also be some salvage
value for the improperly-labeled product. If one assumes that the
disposal cost and the salvage value are relatively minor and, on net,
offset each other, then the upper limit on the relabeling costs for any
product would be approximately 100 percent of the value of the product.
Furthermore, with an effective range of labeling costs from 1.5 percent
to 100 percent of the value of the product, OSHA estimates, without
further information on the distribution of the costs, that the average
labeling cost would be approximately 50 percent of the value of the
products requiring relabeling. While this cost estimate as a percentage
of the value of the product was developed from data on relabeling non-
pesticide agricultural chemical products in distribution, OSHA has
assumed that this same estimate would also apply to relabeling paints
and related chemical products in distribution. The agency invites
comments on this assumption.
The 50 percent average cost savings estimate would apply only to
those products requiring relabeling. In order to estimate the expected
cost savings for all products in the NAICS codes affected by the
proposed revisions to paragraph (f)(11), OSHA also needs to estimate
three other factors (in addition to the average cost savings of 50
percent): (1) What percentage of the products in these NAICS industries
would be warehoused for more than six months; (2) what percentage of
products warehoused for more than six months would be relabeled in any
particular year due to a manufacturer-initiated labeling change; \47\
and (3) the percentage of all products in the NAICS industries that are
covered by this proposed rule.
---------------------------------------------------------------------------
\47\ These labeling changes occur when the manufacturer becomes
newly aware of significant information regarding the hazards of a
chemical. See existing 29 CFR 1910.1200(f)(11).
---------------------------------------------------------------------------
OSHA was unable to identify data relevant to factors (1) and (2)
above and instead worked with its contractor, ERG, to develop estimates
of both of these factors. For (1) above, OSHA expected that the
percentage of products warehoused for more than six months would be
quite low because it is expensive to hold inventory over long periods
of time. Therefore, OSHA estimated that just five percent of the
products in the six NAICS industries potentially impacted by the
proposed modifications to paragraph (f)(11) would be warehoused for
more than six months. For (2) above, OSHA anticipates that
manufacturer-initiated relabeling would be rare, and estimated that
only one percent of products warehoused for more than six months would
be relabeled in any particular year due to a manufacturer-initiated
labeling change to one or more of its chemical ingredients. See
existing 29 CFR 1910.1200(f)(11). OSHA invites comments on these
estimates.
For factor (3) above, OSHA assumed that 100 percent of the products
in the four NAICS manufacturing industries are covered by the HCS.\48\
For the two wholesale industries, however, some substantial portion of
the covered products do not qualify as hazardous chemicals covered by
the HCS or are not subject to the HCS labeling requirements. For NAICS
424910: Farm Supplies Merchant Wholesalers, a significant majority of
the wholesale
[[Page 9655]]
supplies are non-fertilizers, such as grains (e.g., alfalfa, hay,
livestock feeds) and nursery stock (e.g., plant seeds and plant bulbs).
Based on data from the 2012 Economic Census,\49\ ERG estimated that
41.7 percent of the wholesale supplies in NAICS 424910 would be
fertilizers affected by the proposed released-for-shipment provision
(Document ID 0049, tab ``RF Shipment''). For NAICS 424950: Paint,
Varnish, and Supplies Merchant Wholesalers, some proportion of the
wholesale supply consists of non-paints and non-chemicals, such as
wallpaper and painting supplies such as paintbrushes, rollers, and
spray-painting equipment. Based on data from the 2012 Economic Census,
ERG estimated that 77.6 percent of the wholesale supplies in NAICS
424950 would be paints and related chemicals affected by the proposed
released-for-shipment provision (Document ID 0049, tab ``RF
Shipment''). OSHA used ERG's estimates to develop the expected cost
savings attributable to the proposed revisions to paragraph (f)(11).
The agency invites comments on these estimates.\50\
---------------------------------------------------------------------------
\48\ A review of the products covered under the manufacturing
NAICS codes reveals they are all, or almost all, chemicals.
\49\ 2012 Economic Census of the United States, Table
EC1242SLLS1--Wholesale Trade: Subject Series--Product Lines: Product
Lines Statistics by Industry for the U.S. and States: 2012 (Document
ID 0043).
\50\ Under the proposed revisions to paragraph (f)(11), when
relabeling is not required for chemicals that have been released for
shipment, the chemical manufacturer or importer would still be
required to provide an updated label for each individual container
with each shipment. The agency estimates that any incremental costs
associated with providing updated labels are likely to be
negligible, as OSHA believes this is already standard industry
practice.
---------------------------------------------------------------------------
Column 3 of Table VII-18 shows the average product value (revenue)
for each of the six NAICS industries that OSHA expects would be
affected by the proposed modification to paragraph (f)(11).\51\ Column
4 of Table VII-18 shows the number of affected firms (entities) for
each of these six NAICS industries.\52\ Column 5 of Table VII-18 shows
the estimated loss avoided due to the proposed released-for-shipment
provision for each of these six NAICS industries as a percentage of
that industry's revenues. That percentage is the product of the four
factors estimated above: (1) The costs of relabeling as a percentage of
the value of the products requiring relabeling; (2) the percentage of
the products in these NAICS industries that would be warehoused for
more than six months; (3) the percentage of products warehoused for
more than six months that would require relabeling in any particular
year due to a manufacturer-initiated labeling change; and (4) the
percentage of all products in the NAICS industries covered by this
proposed rule.
---------------------------------------------------------------------------
\51\ Derived for each NAICS by dividing Column 3 of Table VII-9
(total industry revenues) by Column 7 of Table VII-1 (number of
affected firms).
\52\ Obtained from Column 7 of Table VII-1.
---------------------------------------------------------------------------
Table VII-17 presents, by NAICS industry, these four factors and
the calculated percentage loss in revenue OSHA anticipates would be
avoided under the proposed released-for-shipment provision.
Table VII-17--Calculation of the Percentage Loss Avoided Due to the Proposed Released-for-Shipment Provision
[2019 Dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percentage of
Percentage of products Percentage of
Percentage products warehoused >= products covered Product of
NAICS NAICS industry cost warehoused >= six months and by the proposed percentages
savings six months require rule
relabeling
(A) (B) (C) (D) (A), (B), (C),
and (D)
--------------------------------------------------------------------------------------------------------------------------------------------------------
325311............................ Nitrogenous Fertilizer 50 5 1 100 0.03
Manufacturing.
325312............................ Phosphatic Fertilizer 50 5 1 100 0.03
Manufacturing.
325314............................ Fertilizer (Mixing Only) 50 5 1 100 0.03
Manufacturing.
325510............................ Paint and Coating Manufacturing.. 50 5 1 100 0.03
424910............................ Farm Supplies Merchant 50 5 1 41.70 0.01
Wholesalers.
424950............................ Paint, Varnish, and Supplies 50 5 1 77.60 0.02
Merchant Wholesalers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.
The estimated cost savings for each of the six affected industries
arising from the proposed modifications to paragraph (f)(11) then is
simply the product of Columns 3, 4, and 5 in Table VII-18. Summing the
cost savings for each of the six industries yields an estimated annual
cost savings of $29.8 million. OSHA requests comments on the
reasonableness of this estimate and the assumptions underlying it
(including the various factor percentage estimates listed in Table VII-
17).
Table VII-18--Cost Savings Associated With the Proposed Released-for-Shipment Provision
[2019 Dollars]
----------------------------------------------------------------------------------------------------------------
Average Loss avoided
NAICS NAICS industry product value Affected firms as a % of Loss avoided
(revenue) revenue
----------------------------------------------------------------------------------------------------------------
325311.................. Nitrogenous Fertilizer $37,902,969 163 0.03 $1,544,546
Manufacturing.
325312.................. Phosphatic Fertilizer 127,231,784 45 0.03 1,431,358
Manufacturing.
325314.................. Fertilizer (Mixing 13,737,854 359 0.03 1,232,972
Only) Manufacturing.
325510.................. Paint and Coating 28,813,229 998 0.03 7,188,901
Manufacturing.
424910.................. Farm Supplies Merchant 28,809,209 4,965 0.01 14,911,683
Wholesalers.
424950.................. Paint, Varnish, and 18,022,834 1,012 0.02 3,538,387
Supplies Merchant
Wholesalers.
---------------------------------------------------------------
[[Page 9656]]
Total............... ...................... .............. 7,542 .............. 29,847,846
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.
Note: Figures may not add to totals due to rounding.
Labels on Very Small Containers
Proposed paragraph (f)(12), which addresses the labeling of small
containers, would limit labeling requirements for chemical
manufacturers, importers, or distributors where they can demonstrate
that it is not feasible to use pull-out labels, fold-back labels, or
tags to provide the full label information as required by paragraph
(f)(1). As proposed in paragraph (f)(12)(ii), manufacturers, importers,
and distributors would be able to use an abbreviated label (requiring
only the product identifier, pictogram(s), signal word, chemical
manufacturer's name and phone number, and a statement that the full
label information is provided on the immediate outer package) on
containers with a volume capacity of 100 ml or less--referred to as
``small containers'' in this PEA. As proposed in paragraph
(f)(12)(iii), manufacturers, importers, and distributors would need to
put only the product identifier on containers with a volume capacity of
3 ml or less--referred to as ``very small containers'' in this PEA--if
they can demonstrate that any label would interfere with the normal use
of the container.
Following publication of the 2012 updates to the HCS, stakeholders
requested that OSHA clarify its enforcement policy on labels for small
containers. In response, through letters of interpretation, OSHA
adopted practical accommodations that specified: (1) The minimum
information required for a label on the immediate container of the
shipped chemical; and (2) the minimum information required for the
outer packaging of shipped small containers (see, e.g., Collatz, 2015,
Document ID 0174; Watters, 2013, Document ID 0200; Blankfield, 2017,
Document ID 0170). Proposed paragraph (f)(12)(ii) would incorporate
into the HCS the accommodations for small containers described in these
letters of interpretation; however, the letters did not contain any
guidance unique to very small containers, which would be covered by
proposed paragraph (f)(12)(iii).
For costing purposes, OSHA estimates that no cost savings will
arise from proposed paragraph (f)(12)(ii) (small containers); OSHA
expects that employers are already benefitting from the practical
accommodations on the labeling of small packages described in the
aforementioned letters of interpretation. OSHA invites public comments
on this preliminary determination and the magnitude of any cost savings
that should be attributed to proposed paragraph (f)(12)(ii).
OSHA has estimated cost savings under proposed paragraph
(f)(12)(iii) for manufacturers, importers, and distributors of very
small containers (volume capacity of 3 ml or less) where the use of any
label (even an abbreviated label as specified in proposed paragraph
(f)(12)(ii)) would interfere with the normal use of the container and
only the product identifier would be required. OSHA has preliminarily
determined that affected manufacturers would fall in only a few NAICS
industries: Other Basic Chemical Manufacturing, Inorganic and Organic
(NAICS 325180 and 325199, respectively) and Pharmaceutical and Medical
Manufacturing (NAICS 3254--encompassing 6-digit NAICS 325411, 325412,
325413, and 325414). As shown in Column 3 of Table VII-19, OSHA
estimates that there are approximately 63.5 million labels on very
small containers in these six 6-digit NAICS manufacturing industries
that OSHA anticipates could be affected by this part of the proposed
rule.\53\
---------------------------------------------------------------------------
\53\ The number of very small containers in Column 3 of Table
VII-19 for each of these six NAICS industries was obtained from
Column 4 of Table VII-5.
---------------------------------------------------------------------------
Even in these six NAICS industries, however, manufacturers would
not be able to take advantage of proposed paragraph (f)(12)(iii) in all
cases because that provision applies only when the manufacturer,
importer, or distributor can demonstrate that it is not feasible to use
pull-out labels, fold-back labels, or tags containing the full label
information and that even an abbreviated label would interfere with the
normal use of the container. Of the 63.5 million potentially affected
labels on very small containers, OSHA estimates that for only 40
percent of them, or for an estimated total of 25.4 million very small
containers, would manufacturers fall under proposed paragraph
(f)(12)(iii) (see Column 5 of Table VII-19 and, equivalently, Column 7
of Table VII-5).
Manufacturers with containers falling under proposed paragraph
(f)(12)(iii) could expect to obtain cost savings from avoided labeling
costs on very small containers (with only the product identifier
required) versus the labeling costs of abbreviated labels (requiring
the product identifier, pictogram(s), signal word, manufacturer's name
and phone number, and a statement that the full label information is
provided on the immediate outer packaging). OSHA estimates an
incremental unit cost savings of $0.051 per label for very small
containers.\54\ That unit cost savings is expected to be net of the
cost of providing a full label on the immediate outer package
(containing a set of very small containers) per proposed paragraph
(f)(12)(iv)(A). As shown in Table VII-19, multiplying the number of
affected labels by the unit cost savings of $0.051 per label for very
[[Page 9657]]
small containers yields estimated annual cost savings of $1.3 million.
OSHA invites interested parties to provide comments on these cost
estimates and the assumptions underlying them.
---------------------------------------------------------------------------
\54\ The Flavor and Extract Manufacturers Association of the
United States (FEMA) provided OSHA (in a letter to Robert Stone of
OSHA, dated April 27, 2018) (Document ID 0257) a summary of survey
results obtained from member companies concerning how they might
benefit from relaxed OSHA labeling requirements on small containers.
Those results included an estimate of $0.85 per label for small
capacity containers compliant with the 2012 HCS. However, this
estimate applies to expensive labels--such as pull-out labels, fold-
back labels, and full-information tags--and therefore is not
applicable to the cost savings associated with using only the
product identifier in lieu of the abbreviated labeling specified in
proposed paragraph (f)(12)(ii). OSHA believes it is likely that most
of the cost savings reported from the FEMA survey would be
attributable to the expensive types of labels.
Based on the unit cost data provided by FEMA, OSHA estimated a
unit cost savings of $0.05 in 2018 dollars for the use of labels
with the minimum information--the product identifier--required for
very small containers (versus abbreviated labels). Updating the 2018
estimate to 2019 dollars using the BEA (2020) implicit price
deflator for Gross Domestic Product, OSHA derived an estimate of
$0.05087 in cost savings per label (with the unrounded estimate used
in the analysis).
Table VII-19--Estimated Cost Savings Associated With Abbreviated Labels on Very Small Containers Under the
Proposed HCS Standard
[2019 Dollars]
----------------------------------------------------------------------------------------------------------------
Labels-- very Percentage of
NAICS NAICS industry small labels with Labels w/cost Annual cost
containers cost savings savings savings
----------------------------------------------------------------------------------------------------------------
325180.................. Other Basic Inorganic 14,768,423 40 5,907,369 $300,518
Chemical
Manufacturing.
325199.................. All Other Basic 35,524,371 40 14,209,748 722,874
Organic Chemical
Manufacturing.
325411.................. Medicinal and 5,106,176 40 2,042,471 103,904
Botanical
Manufacturing.
325412.................. Pharmaceutical 6,471,452 40 2,588,581 131,685
Preparation
Manufacturing.
325413.................. In-Vitro Diagnostic 501,664 40 200,665 10,208
Substance
Manufacturing.
325414.................. Biological Product 1,113,080 40 445,232 22,650
(except Diagnostic)
Manufacturing.
---------------------------------------------------------------
Total............... ...................... 63,485,165 40 25,394,066 1,291,839
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health.
Note: Figures may not add to totals due to rounding.
Sensitivity Analysis
In this section, OSHA presents the results of a sensitivity
analysis to demonstrate how robust the estimates of net cost savings
are to changes in various cost parameters. In this analysis, OSHA made
a series of isolated changes to individual cost input parameters in
order to determine their effects on the agency's estimates of
annualized net cost savings, with a seven-percent discount rate as the
reference point. The agency has conducted these calculations for
informational purposes only.
The methodology and calculations underlying the cost estimates
associated with this rulemaking are generally linear and additive in
nature. Thus, the sensitivity of the results and conclusions of the
analysis will generally be proportional to isolated variations in a
particular input parameter. For example, if the estimated time that
employees will need to devote to attending new training doubles, the
corresponding labor costs would double as well.
OSHA evaluated a series of such changes in input parameters to test
whether and to what extent the general conclusions of the preliminary
economic analysis held up. OSHA considered changes to input parameters
that affected only costs and cost savings and determined that each of
the sensitivity tests on cost parameters had only a very minor effect
on total costs or net costs. On the whole, OSHA found that the
conclusions of the analysis are robust, as changes in any of the cost
input parameters still show significant net cost savings for the final
rule. The results of the individual sensitivity tests are summarized
and are described in more detail in Table VII-20.
In the first of these sensitivity tests, OSHA reduced from 1
percent to 0.5 percent its estimate of the percentage of products
warehoused for more than six months that require relabeling in any
particular year. The effect of this change would be to reduce by 50
percent the estimated cost savings associated with the proposed
released-for-shipment provision. Table VII-20 shows that the estimated
net cost savings from the proposed rule would decline by $14.9 million
annually, from $26.8 million to $11.8 million annually, or by about 56
percent.
In a second sensitivity test, OSHA reversed the first sensitivity
test, that is, the agency increased from 1 percent to 2 percent the
percentage of products warehoused for more than six months that require
relabeling in any particular year. The effect of this change would be
to increase by 100 percent the estimated cost savings associated with
the proposed released-for-shipment provision. Table VII-20 shows that
the estimated net cost savings from the proposed rule would increase by
$29.8 million annually, from $26.8 million to $56.6 million annually,
or by about 112 percent.
In a third sensitivity test, OSHA reduced from 40 percent to 20
percent the percentage of very small containers that would be affected
by proposed paragraph (f)(12). As shown in Table VII-20, if OSHA's
estimates of other input parameters remained unchanged, the estimated
net cost savings from the proposed rule would decline by $0.6 million
annually, from $26.8 million to $26.1 million annually, or by about 2
percent.
In a fourth sensitivity test, OSHA applied the same rule
familiarization costs to all firms regardless of whether they are
affected by other provisions of this proposal, i.e., OSHA did not
reduce estimated familiarization time for firms that are not affected
by other parts of the proposal. The effect of this change would be to
raise compliance costs for 102,624 establishments in manufacturing and
wholesale trade; the estimated net cost savings from the proposed rule
would be reduced by $0.4 million annually, from $26.8 million to $26.4
million annually, or by about 1 percent.
In a fifth sensitivity test, OSHA doubled the estimated labor hours
assigned to revising SDSs and labels due to the reclassification of
chemicals and revised mandatory language in the appendices of the HCS
(from Tables VII-13 and VII-14). The effect of this change would be to
double labor costs for the affected six-digit NAICS industries;
estimated net cost savings would be reduced by $3.5 million annually,
from $26.8 million to $23.2 million, or by 13.2 percent.
In a sixth sensitivity test, OSHA excluded overhead costs from the
fully loaded hourly wage rates used throughout the PEA. Overhead costs
were not applied in the 2012 FEA and this sensitivity test provides
consistency with the treatment of overhead in the 2012 analysis. The
effect of this change would be to remove the factor of 17 percent of
base wages from the hourly costs for the four job categories used in
the cost analysis. Applying this change, the estimated net cost savings
from the proposed rule would increase by $0.5 million annually, or by
1.7 percent, resulting in a total estimate of annualized net cost
savings of $27.2 million.
[[Page 9658]]
Table VII-20--Sensitivity Tests and Regulatory Alternatives--Impacts on Net Cost Savings
[7 Percent discount rate, 2019 dollars]
----------------------------------------------------------------------------------------------------------------
Percentage
Uncertainty (cost) scenarios Change from OSHA's best Difference from impact on net Net cost
estimate proposed rule cost savings savings
----------------------------------------------------------------------------------------------------------------
Proposed Rule--OSHA's midpoint N/A.................... $0 0.0 $26,753,711
estimate.
Reduce from 1 percent to 0.5 percent Halves cost savings -$14,923,923 -55.8 11,829,788
the percentage of products associated with
warehoused for more than six months proposed released-for-
that would require relabeling in any shipment provision.
particular year.
Increase from 1 percent to 2 percent Doubles cost savings 29,847,846 111.6 56,601,557
the percentage of products associated with
warehoused for more than six months proposed released-for-
that would require relabeling in any shipment provision.
particular year.
Reduce from 40% to 20% the percentage Halves cost savings for -645,919 -2.4 26,107,792
of very small containers that would affected firms.
be affected by proposed paragraph
(f)(12).
Rule familiarization time would not Raises costs for the -366,679 -1.4 26,387,032
be reduced for firms that are not 31,577 establishments
affected by any other cost in NAICS 31-33--
provisions; it would be identical to Manufacturing, and the
rule familiarization time for those 71,047 establishments
that are affected by other in NAICS 42--Wholesale
provisions. Trade not affected by
other provisions.
Doubles labor hours for the Doubles labor costs for -3,529,921 -13.2 23,223,790
reclassification of chemicals and the approximately 13
compliance with the new mandatory six-digit NAICS
language in the appendices to the industries affected by
proposed standard. proposed changes to
paragraph (d) and
appendices B, C, and D.
Excludes overhead costs from fully For the four job 458,003 1.7 27,211,714
loaded hourly wage rates. categories in the cost
model, overhead costs
(17 percent of base
wages) are not applied
and estimated wage
rates are
correspondingly lower.
Remove the proposed provisions that Eliminates cost savings -1,291,839 -4.8 25,461,873
result in cost savings for very for affected employers.
small labels.
Eliminate the proposed released-for- Eliminates cost savings -29,847,846 -111.6 -3,094,135
shipment provisions and associated for affected employers.
cost savings.
----------------------------------------------------------------------------------------------------------------
Source: U.S. DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis-Health (Document ID
0049, tab ``Tables'').
Not part of this table, but discussed in A. Introduction and
Summary, the agency examined the effect of lowering the discount rate
for annualizing costs from 7 percent to 3 percent. Lowering the
discount rate to 3 percent would yield annualized net cost savings of
$27.5 million, approximately $700,000 more in annual cost savings than
the net cost savings at a 7 percent discount rate.
Regulatory Alternatives
This section discusses two regulatory alternatives to the changes
OSHA is proposing in this NPRM: (1) Removing the proposed changes to
paragraph (f)(12) regarding labeling of very small containers, which
would eliminate cost savings for manufacturers, importers, and
distributors that label such containers; and (2) removing the proposed
changes to paragraph (f)(11) regarding labeling of containers that have
been released-for-shipment, which would eliminate cost savings for
manufacturers, importers, and distributors that have such containers.
In Table VII-20, each regulatory alternative is described and analyzed
relative to the proposed revisions to the HCS. Midpoint estimates are
presented in all cases. Under Regulatory Alternative (1) (elimination
of changes related to labeling of very small containers), cost impacts
total $1.3 million (4.8 percent of baseline cost savings), resulting in
a reduction of estimated annualized net cost savings to a total of
$25.5 million. Under Regulatory Alternative (2) (elimination of changes
related to labels on packages that have been released for shipment),
cost impacts on employers total $29.8 million (112 percent of baseline
cost savings), resulting in an overall estimate of annualized net costs
of $3.1 million.
In summary, these regulatory alternatives would result in a
reduction of cost savings--a significant reduction in the case of the
second alternative (resulting in positive, but modest, overall net
costs). The elimination of neither alternative, however, would alter
the agency's determination of economic feasibility for the proposed
revisions to the HCS as a whole. Nor would the elimination of these
alternatives result in a significant impact on a substantial number of
small entities (see Section VII. G. Economic Feasibility and Impacts).
G. Economic Feasibility and Impacts
This section presents OSHA's analysis of the potential economic
impacts of the proposed rule and an assessment of economic feasibility.
A separate analysis of the potential economic impacts on small entities
(as defined in accordance with SBA criteria) and on very small entities
(those with fewer than 20 employees) is presented in the following
section as part of the Initial Regulatory Flexibility Screening
Analysis, conducted in accordance with the criteria laid out in the
Regulatory Flexibility Act.
A standard is economically feasible ``if it does not threaten
massive dislocation to, or imperil the existence of, [an] industry.''
Lead I, 647 F.2d at 1265 (internal citations and quotation marks
omitted). To determine whether a rule is economically feasible, OSHA
begins with two screening tests to consider minimum threshold effects
of the rule under two extreme cases: (1) A scenario in which all costs
are passed through to customers in the form of higher prices
(consistent with a price elasticity of demand of zero); and (2) a
scenario in which all costs are absorbed by the firm in the form of
reduced profits (consistent with an infinite price elasticity of
demand).
In profit-earning entities, compliance costs can generally be
expected to be absorbed through a combination of increases in prices
and reductions in profits. The extent to which the impacts of cost
increases affect prices or profits depends on the price elasticity of
demand for the products or services produced and sold by the entity.
The price elasticity of demand refers to the relationship between
changes in the price charged for a product and the resulting changes in
the demand for that product. A larger price elasticity of demand
implies that an entity or industry is less able to pass increases in
costs through to its customers in the form of a price increase and must
absorb more of the cost increase through a reduction in profits.
[[Page 9659]]
If the price elasticity of demand is zero, and all costs can be
passed to customers in the form of higher prices, the immediate impact
of the rule would be observed in the form of increased industry
revenues. In the absence of evidence to the contrary, OSHA generally
considers a standard to be economically feasible for an industry when
the annualized costs of compliance are less than a threshold level of
one percent of annual revenues. Common-sense considerations indicate
that potential impacts of such a small magnitude are unlikely to
eliminate an industry or significantly alter its competitive structure,
particularly since most industries have at least some ability to raise
prices to reflect increased costs and normal price variations for
products typically exceed three percent a year (OSHA, 2016, Chapter VI,
pp. VI-20/VI-23 and Table VI-3). \55\ Of course, OSHA recognizes that
even when costs are within this range, there could be unusual
circumstances requiring further analysis.
---------------------------------------------------------------------------
\55\ Document ID OSHA-2010-0034-4247, Attachment ``Silica FEA
Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility
Determination'' (Document ID 0045).
---------------------------------------------------------------------------
If, however, there is infinite price elasticity of demand, and all
costs are absorbed by affected firms, the immediate impact of the rule
would be observed in reduced industry profits. OSHA uses the ratio of
annualized costs to annual profits as a second check on economic
feasibility. In the absence of evidence to the contrary, OSHA generally
considers a standard to be economically feasible for an industry when
the annualized costs of compliance are less than a threshold level of
ten percent of annual profits. This is a fairly modest threshold level,
given that normal year-to-year variations in profit rates in an
industry can exceed 40 percent or more (OSHA, 2016, Chapter VI, pp. VI-
20/VI-23 and Table VI-5).\56\
---------------------------------------------------------------------------
\56\ Document ID OSHA-2010-0034-4247, Attachment ``Silica FEA
Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility
Determination'' (Document ID 0045).
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In order to assess the nature and magnitude of the economic impacts
associated with compliance with the proposed rule, OSHA developed
quantitative estimates of the potential economic impact of the
requirements on each of the affected industry sectors. The estimated
costs of compliance presented in Section VII.F of this preamble were
compared with industry revenues and profits to provide a measure of
potential economic impacts. Table VII-21 presents data on revenues and
profits for each affected industry sector at the six-digit NAICS
industry level, along with the corresponding estimated annualized costs
of compliance in each sector. Potential impacts in the table are
represented by the ratios of compliance costs to revenues and
compliance costs to profits.
The nature of the proposed revisions to the HCS is such that all
affected firms would incur some costs, but only a small subset would
derive the cost savings that are monetized in this PEA (although most
or all would enjoy non-monetized benefits, e.g., in foreign trade). To
examine the economic impacts of the proposed revisions to the standard
for those affected establishments that obtain no monetized cost savings
from any of the proposed revisions to the HCS, OSHA estimated the ratio
of compliance costs to revenues and the ratio of compliance costs to
profits using only gross positive costs (i.e., costs exclusive of cost
savings) as the numerator in the ratio. Table VII-22 presents this part
of the agency's screening analysis.
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In the case of costs that may be incurred due to the requirements
of the proposed revisions to the HCS, all businesses within each of the
covered industry sectors would be subject to the same requirements.
Thus, to the extent
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potential price increases correspond to costs associated with achieving
compliance with the revised standard, the elasticity of demand for each
entity will approach that faced by the industry as a whole.
Furthermore, if OSHA adopts the proposed revisions to the HCS,
hazardous chemicals distributed in the United States will have to be in
compliance with the updated provisions, and chemical producers and
users in most advanced economies will be operating under comparable
requirements based on the GHS specific to their own country or economic
union. For this reason, affected domestic establishments should not be
susceptible to a loss of domestic market share resulting from the
competition of foreign commercial entities not bound by the
requirements of the HCS or similar GHS requirements.
Given the small increases in prices potentially resulting from
compliance with the proposed revisions to the HCS in any particular
industry, and the lack of readily available substitutes for the
products and services provided by the covered industry sectors, demand
is expected to be sufficiently inelastic in each affected industry to
enable entities to substantially offset compliance costs through minor
price increases without experiencing any significant reduction in
revenues or profits. For example, for NAICS 324191: Petroleum
Lubricating Oil and Grease Manufacturing, even if zero cost savings are
obtained and gross positive costs reach OSHA's estimated total
($1,221,994; see Table VII-22), revenue impacts (0.0074 percent,
rounded to 0.01 percent) and profit impacts (0.108 percent, rounded to
0.11 percent) fall well below OSHA's screening criteria associated with
economic feasibility concerns. OSHA therefore preliminarily concludes
that the proposed rule, if implemented, would be economically feasible.
The agency invites comments on this preliminary conclusion.
H. Preliminary Regulatory Flexibility Act Certification
To determine whether the proposed revisions to the HCS will have a
significant economic impact on a substantial number of small entities,
OSHA evaluated the impact of compliance costs on the revenues and
profits of small entities in affected industries. As discussed
previously, the proposed rule would impose costs on impacted industries
for training; for reclassification of aerosols, desensitized
explosives, and flammable gases; and for becoming familiar with the
proposed changes to the standard. The proposed rule would also result
in cost savings to the extent it would limit employers' duties with
respect to the labeling of some very small containers and provide more
flexible relabeling requirements for packaged chemicals released for
shipment.
OSHA believes that the estimated costs are one-time costs that
would be incurred during the first-year transition period after the
rule is promulgated. In addition, as mentioned above, there will be
annual cost savings due to the flexibilities introduced in the proposed
provision related to the labeling of very small containers and in the
proposed released-for-shipment provision.
Tables VII-23 and VII-24 present OSHA's screening analysis of the
impact of compliance costs and cost savings on revenues and profits of
small and very small entities. Tables VII-25 and VII-26 present OSHA's
screening analysis of impacts on revenues and profits for small and
very small entities under the scenario that zero-cost savings are
realized, i.e., only positive costs are incurred by affected employers.
OSHA's screening criteria for determining whether there are significant
economic impacts on small firms assesses whether, for small entities in
any given industry, the annualized costs exceed one percent of revenues
or five percent of profits.\57\
---------------------------------------------------------------------------
\57\ OSHA's screening criteria underlying the determination of
significant economic impacts were developed in accordance with
published guidelines for implementation of the Small Business
Regulatory Enforcement Fairness Act amendment to the Regulatory
Flexibility Act; Executive Orders 12866, 13563, and 13771; and the
Unfunded Mandates Reform Act. For a recent example of the
application of these screening criteria, see the Final Economic
Analysis and Final Regulatory Flexibility Analysis for the Final
Rule for Occupational Exposure to Respirable Crystalline Silica,
Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility
Determination, Document ID 0045.
---------------------------------------------------------------------------
The total annualized cost savings resulting from the proposed
revisions to the HCS for small entities and very small entities are
estimated to be approximately $17.1 million and $1.7 million,
respectively (see Tables VII-23 and VII-24). To assess the potential
economic impact of the proposed rule on small entities and very small
entities, OSHA calculated the ratios of compliance costs to profits and
to revenues. These ratios are presented for each affected industry in
Tables VII-23 (small entities) and VII-24 (very small entities). Those
tables show that in no industries do the annualized costs of the
proposed revisions to the standard exceed one percent of annual
revenues or five percent of annual profits, either for small entities
or for very small entities. Similarly, under a cost scenario exclusive
of cost savings (shown in Tables VII-25 and VII-26), in no industries
do the annualized costs of the proposed rule exceed one percent of
annual revenues or five percent of annual profits. Because no adverse
revenue and profit impacts are expected to result from this proposed
revision to the HCS, OSHA preliminarily certifies that the proposed
changes to the standard will not have a significant economic impact on
a substantial number of small entities. The agency invites comments on
this preliminary certification.
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VIII. Federalism
OSHA reviewed the proposed updates to the HCS according to the most
recent Executive order on federalism (E.O. 13132, 64 FR 43255), which
requires that Federal agencies, to the extent possible, refrain from
limiting State policy options, consult with States before taking
actions that would restrict States' policy options and take such
actions only when clear constitutional and statutory authority exists
and the problem is of national scope. The Executive order generally
allows Federal agencies to preempt State law only with the expressed
consent of Congress. Federal agencies must limit preemption of State
law to the extent possible.
Under section 18 of the OSH Act, 29 U.S.C. 667, Congress expressly
provides that States and U.S. territories may adopt, with Federal
approval, a plan for the development and enforcement of occupational
safety and health standards. OSHA refers to such States and territories
as State Plan States. Occupational safety and health standards
developed by State Plan States must be at least as effective in
providing safe and healthful employment and places of employment as the
Federal standards and, when applicable to products that are distributed
or used in interstate commerce, must be required by compelling local
conditions and not unduly burden interstate commerce. 29 U.S.C.
667(c)(2). Subject to these requirements, State Plan States are free to
develop and enforce their own requirements for safety and health
standards.
In States without OSHA-approved State plans, Congress expressly
provides for OSHA standards to preempt State occupational safety and
health standards in areas addressed by the Federal standards. In these
States, the proposed revisions to the HCS would limit State policy
options in the same manner as every standard or amendment to a standard
promulgated by OSHA. In States with OSHA-approved State plans, the
proposed revisions to the HCS would not significantly limit State
policy options to adopt stricter standards.
OSHA previously concluded that promulgation of the HCS complies
with E.O. 13132 (77 FR 17687), and reaffirms that finding with respect
to the proposed revisions to that standard.
VIX. State Plan States
When Federal OSHA promulgates a new standard or more stringent
amendment to an existing standard, the 28 States and U.S. territories
with their own OSHA-approved occupational safety and health plans
(``State Plan States'') must amend their standards to reflect the new
standard or amendment or show why such action is unnecessary, e.g.,
because an existing State standard covering this area is ``at least as
effective'' as the new Federal standard or amendment. 29 CFR 1953.5(a).
The State standard must be at least as effective as the final Federal
rule, and, when applicable to products that are distributed or used in
interstate commerce, must be required by compelling local conditions
and not unduly burden interstate commerce. 29 U.S.C. 667(c)(2). State
Plans must adopt the Federal standard or complete their own standard
within six months of the promulgation date of the final Federal rule.
When OSHA promulgates a new rule or amendment that does not impose
additional or more stringent requirements than existing standards,
State Plan States are not required to amend their standards, although
OSHA may encourage them to do so.
The 22 States and territories with OSHA-approved occupational
safety and health plans that cover public and private-sector employees
are Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky,
Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina,
Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont,
Virginia, Washington, and Wyoming. Another six states and territories
have OSHA-approved occupational safety and health plans that cover
State and local government employees only: Connecticut, Illinois,
Maine, New Jersey, New York, and the Virgin Islands.
X. Unfunded Mandates Reform Act
OSHA reviewed this proposal according to the Unfunded Mandates
Reform Act of 1995 (UMRA), U.S.C. 1501 et seq., and Executive Order
13132 (64 FR 43255). As discussed in the Preliminary Economic Analysis,
OSHA has preliminarily concluded that the proposed revisions to the HCS
will not impose a Federal mandate on the private sector in excess of
$100 million (adjusted annually for inflation) in expenditures in any
one year.
As noted previously, OSHA's standards do not apply to State and
local governments except in States that have elected voluntarily to
adopt a State Plan approved by the agency. Consequently, this proposal
does not meet the definition of a ``Federal intergovernmental
mandate.'' See 2 U.S.C. 658(5).
The OSH Act does not cover tribal governments in the performance of
traditional governmental functions, though it generally does cover
tribal governments when they engage in commercial activity. The
proposed changes to the HCS would not require tribal governments to
expend, in the aggregate, $100 million or more in any one year for
their commercial activities.
For these reasons, for the purposes of the UMRA, OSHA certifies
that this proposal would not mandate that State, local, or tribal
governments adopt new, unfunded regulatory obligations of, or increase
expenditures by the private sector by, more than $100 million in any
year. In any event, the Preliminary Economic Analysis constitutes a
written statement containing a qualitative and quantitative assessment
of the anticipated costs and benefits. See 2 U.S.C. 1532.
XI. Protecting Children From Environmental Health and Safety Risks
Executive Order 13045 (62 FR 19885), requires that Federal agencies
submitting covered regulatory actions to OMB's Office of Information
and Regulatory Affairs (OIRA) for review pursuant to E.O. 12866 provide
OIRA with (1) an evaluation of the environmental health or safety
effects that the planned regulation may have on children, and (2) an
explanation of why the planned regulation is preferable to other
potentially effective and reasonably feasible alternatives considered
by the agency. E.O. 13045 defines ``covered regulatory actions'' as
rules that are likely to (1) be economically significant under E.O.
12866 (i.e., a rulemaking that has an annual effect on the economy of
$100 million or more, or would adversely affect in a material way the
economy, a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities), and (2) concern an environmental health
risk or safety risk that an agency has reason to believe may
disproportionately affect children. In this context, the term
``environmental health risks and safety risks'' means risks to health
or safety that are attributable to products or substances that children
are likely to come in contact with or ingest (e.g., through air, food,
water, soil, or product use).
OSHA has preliminarily determined that the proposed revisions to
the HCS are not economically significant under E.O. 12866 (see Section
VII of this preamble) and that the standard would not pose
environmental health or safety
[[Page 9687]]
risks to children as set forth in E.O. 13045.
XII. Environmental Impacts
OSHA has reviewed the proposed revisions to the HCS according to
the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et
seq.), the regulations of the Council on Environmental Quality (40 CFR
part 1500), and the Department of Labor's NEPA procedures (29 CFR part
11). As a result of that review, OSHA has made a preliminary
determination that the proposed regulatory changes will have no impact
on air, water, or soil quality; plant or animal life; or the use of
land or aspects of the external environment. Therefore, OSHA
preliminarily concludes that the proposed revisions to the HCS would
have no significant environmental impacts.
XIII. Consultation and Coordination With Indian Tribal Governments
OSHA reviewed the proposed revisions to the HCS in accordance with
E.O. 13175 on ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249), and determined that it does not have
``tribal implications'' as defined in that order. The amendments, if
promulgated, would not have substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.
XIV. Issues and Options Considered
OSHA is providing this issues and options section to solicit
stakeholder input on various regulatory issues and to allow for some
potential regulatory flexibility with respect to the content of any
final rule resulting from this rulemaking. While OSHA invites
stakeholders to comment on all aspects of this proposal, this section
identifies specific areas of interest to the agency. OSHA is including
certain issues and questions in this section to assist stakeholders as
they review the proposal and consider the comments they plan to submit.
However, to fully understand the questions, and to provide substantive
input and feedback in response to them, the agency suggests commenters
review the other sections of the preamble that address these issues in
detail. Some issues and options that have cost implications are
discussed more thoroughly in the Preliminary Economic Analysis (see
Section VII. Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis).
A. Issues
In this section, OSHA solicits public feedback on specific issues
associated with the proposed revisions to the HCS. It should be noted
that the proposed regulatory text provided at the end of this document
only includes those paragraphs that OSHA is proposing to change.
Therefore, the agency is putting a marked-up version (redline strike
out) of the text of the current rule on its web page and in the docket
to help readers identify and understand the proposed changes in context
(OSHA HCS Redline, 2020, Document ID 0222). The marked-up text will be
found on www.osha.gov under Hazard Communication in the subject index.
OSHA has organized this issues section to follow the order of the
preamble and requests that feedback be organized, to the extent
possible, in similar order. Comments and feedback on particular
provisions should contain the heading of the section (e.g., Regulatory
Text, Appendix A), the associated issue number, and, where appropriate,
the paragraph in the standard that the comment is addressing. Comments
addressing more than one section or paragraph should include all
relevant references. Submitting comments in an organized manner with
clear reference to the issue(s) raised will enable all participants to
better understand the issues the commenter addressed and how they
addressed them. Some commenters may confine their interest (and
comments) to the issues that specifically affect them; correspondingly
they will benefit from being able to quickly identify comments on these
issues in others' submissions. While the agency welcomes relevant
comments on any aspect of this proposal, OSHA is especially interested
in responses, supported by evidence and explanations, to the following
issues and questions:
Timeframe for Updates to the HCS
Since aligning the HCS with the GHS Rev. 3 in 2012, OSHA has
intended for the HCS to stay current with more recent revisions of the
GHS. The GHS is updated biennially through published revisions; most
recently, revision 8 was published in July 2019 (UN GHS, Rev. 8,
Document ID 0065). Regulatory authorities around the world have
implemented the GHS at stages ranging from revision 1 through revision
5. Few regulatory authorities have put programs in place to update
their regulations on a routine schedule. The European Union (EU) has
made the most regular updates, and has most recently implemented the
GHS Rev. 5 in August, 2016 (ECHA, 2016, Document ID 0177). In March
2019, the European Commission (EC) published the adaptation of
technical progress (ATP) to EC regulation 1272/2008 (the
Classification, Labelling, and Packaging (CLP) regulation) to align
with both the sixth and seventh revised editions of the GHS (EC, 2019,
Document ID 0176). These changes to the EC regulation become effective
October 17, 2020. Other regulatory authorities, such as those in
Canada, Australia, and New Zealand, have indicated that they will
continue to update their regulations to align with the GHS and are in
the process of aligning with Rev. 7; however, none of these countries
have a mandate on how often they should do so (Canada, 2019, Document
ID 0172; Australia, 2020, Document ID 0168; New Zealand, 2018, Document
ID 0187). Similarly, to date, OSHA has not adopted a specific timeframe
for regularly updating the HCS to implement GHS updates.
As stated previously, OSHA is proposing to align the HCS with the
GHS Rev. 7, consistent with the actions of most of the countries listed
above (EC, 2019, Document ID 0176; Canada, 2019, Document ID 0172;
Australia, 2020, Document ID 0168; New Zealand, 2018, Document ID
0187). A more thorough explanation of OSHA's preliminary decision to
align the HCS with the GHS Rev. 7 is detailed in the introduction to
Section XV.
OSHA requests public comment on whether the agency should adopt a
schedule for updates to the HCS standard (e.g., every four years or
every two revisions of the GHS) or wait until there are significant
changes to the GHS before initiating rulemaking. More frequently
updating the HCS to align with the GHS may provide greater protection
for workers and reduce uncertainty for manufacturers, distributors, and
employers. For example, in the GHS Rev. 7, several hazard classes have
been updated to include additional hazard sub-categories and improved
hazard information that will increase clarity and, therefore,
protections for workers.
OSHA is interested in receiving public comment about the utility,
costs, or other issues that might be associated with regular updates
and about specific timeframes or criteria that OSHA should consider
when determining when and whether to update the HCS. Specifically,
would longer time periods between updates and realignment with the GHS
and other standards be more or less burdensome for employers,
especially those that operate
[[Page 9688]]
internationally? Would regular, shorter time periods provide more
stability? How would longer or shorter periods between realignment
affect worker protection?
Regulatory Text
(1) Under paragraph (f), Labels and other forms of warning, OSHA is
proposing changes to paragraphs (f)(5) (bulk shipments) and (f)(11)
(released-for-shipment) and is also proposing to add a new paragraph
(f)(12) containing provisions specific to labelling on small
containers.
(a) OSHA is requesting comments on the proposed additions to
paragraph (f)(5), which would be newly titled Transportation. Proposed
paragraph (f)(5)(ii) would provide that labels for bulk shipments may
be placed on the immediate container or may be transmitted with the
shipping papers or bills of lading or by other technological or
electronic means as long as the label is immediately available to
workers in printed form at the receiving end of the shipment. OSHA
requests comments on the usefulness and effectiveness of allowing these
alternate approaches for labeling bulk shipments.
(b) OSHA is proposing to update paragraph (f)(11) to provide that
chemicals that have been released for shipment and are awaiting future
distribution need not be relabeled to incorporate new significant
information about hazards; however, the chemical manufacturer or
importer would still have to provide the updated label for each
individual container with each shipment. The purpose of this proposal
is to account for the long distribution cycles of some products and the
potential hazards workers could face in relabeling the immediate
containers of hazardous chemicals (e.g., chemical exposures, ergonomic
issues). OSHA requests comments on whether it is appropriate to use
``released for shipment'' as the cutoff point for relabeling
requirements, as opposed to, for example, the time of shipment. Would
the proposed provision reduce worker protections, considering OSHA is
also proposing to require that the updated label be sent with the
shipment? Would the proposed change result in any cost savings?
(c) OSHA is proposing a new paragraph (f)(12) addressing labeling
requirements for small containers. All of the provisions in this
proposed paragraph would apply only where the chemical manufacturer,
importer, or distributor can demonstrate that it is not feasible to use
pull-out labels, fold-back labels, or tags containing the full label
information required by paragraph (f)(1). Paragraph (f)(12)(ii), as
proposed, would provide that labels for small containers less than or
equal to 100 ml capacity must include just the product identifier,
pictogram(s), signal word, chemical manufacturer's name and phone
number, and a statement that the full label information for the
hazardous chemical is provided on the immediate outer package. In
addition, proposed (f)(12)(iii) would eliminate labeling requirements
for small containers less than or equal to 3 ml capacity where the
manufacturer, importer, or distributor can demonstrate that any label
would interfere with the normal use of the container; in such cases,
however, the proposed revisions to the standard would require the
container to bear, at a minimum, the product identifier. For example,
the product identifier could be etched on a small glass vial. This
would ensure that each small container can be identified and linked
with the full label information on the immediate outer package. OSHA is
also proposing a provision at paragraph (f)(12)(iv), applicable to all
small containers covered by paragraph (f)(12)(ii) or (iii), providing
that the immediate outer package must include (1) the full label
information for each hazardous chemical in the immediate outer package;
and (2) a statement indicating that the small container(s) inside must
be stored in the immediate outer package (bearing the complete label)
when not in use. OSHA requests comments on the feasibility of, and any
cost savings associated with, these proposed provisions for the
labeling of small containers (both 100 ml and less and 3 ml and less).
The agency also requests information on whether the proposed labeling
requirements would be adequate to provide for safe handling and storage
of chemicals in small containers. In addition, OSHA is interested in
receiving comments on two specific alternatives to proposed paragraph
(f)(12). First, instead of adopting proposed paragraph (f)(12), should
OSHA simply allow for case-by-case exemptions if full labeling is not
feasible? Second, should the agency require a showing that a full label
would interfere with the normal use of the container before permitting
the use of abbreviated labels on containers with a capacity of 100 ml
and less (similar to the condition OSHA is proposing in paragraph
(f)(12)(iii) for containers with a capacity of 3 ml and less)? Please
provide reasons for your answers.
(2) Under paragraph (g) Safety data sheets, OSHA is proposing a
change to paragraph (g)(10), which addresses the form and storage of
safety data sheets, to allow SDSs to be stored, rather than designed,
in a way that covers groups of hazardous chemicals in a work area. The
original term ``design'' was used when OSHA did not require a specific
format for material safety data sheets (MSDSs), but now that OSHA
requires SDSs to be in a standard 16-section format, the agency is
proposing to clarify that this paragraph refers to storage only. OSHA
requests comments regarding whether this proposed revision would
require significant changes to current practices.
(3) Under paragraph (i), Trade secrets, OSHA is proposing two
significant changes.
(a) First, OSHA is proposing to allow manufacturers, importers, and
employers to withhold a chemical's concentration range as a trade
secret.
(b) Second, in proposed paragraphs (i)(1)(iv)(A) through (M), OSHA
is proposing the use of prescriptive concentration ranges in lieu of
the actual concentration or concentration range whenever the actual
concentration or concentration range is claimed as a trade secret; the
proposed ranges are the same as those required by Canada, a major
trading partner of the United States (Canada, 2019, Document ID 0172).
OSHA currently does not permit manufacturers to claim concentration
ranges as trade secrets (Colau, 2017, Document ID 0098; Nelson, 2017,
Document ID 0099), and is requesting comments on its proposal to do so.
Specifically, the agency is interested in any experience stakeholders
have had with developing SDSs using the prescribed concentration ranges
and any concerns stakeholders have about using concentration ranges on
the SDS. The agency is also requesting comments addressing the adequacy
of hazard information provided by these ranges. Do these ranges provide
sufficient information for downstream manufacturers to conduct hazard
classifications? Are the ranges prescribed too wide to provide
sufficient information to protect workers (i.e., should they be
narrowed)? Notably, proposed paragraph (i)(1)(v) provides that the
prescribed concentration range used must be the narrowest range
possible. If the exact concentration range falls between 0.1% and 30%
(proposed paragraphs (i)(1)(iv)(A) through (G)) and does not fit
entirely into one of the prescribed concentration ranges, a single
range created by the combination of two applicable consecutive ranges
could be disclosed instead, provided that the combined concentration
range does not include any range that falls entirely outside the
[[Page 9689]]
exact concentration range in which the ingredient is present. OSHA
invites comments on whether it should allow combinations among all
ranges (i.e., all of the ranges (up to 100% concentration) listed in
proposed paragraphs (i)(1)(iv)(A) through (M)) or whether the rule
applicable to combining ranges should be even more restrictive (e.g.,
only for the ranges (up to 10% concentration) listed in proposed
paragraphs (i)(1)(iv)(A) through (E)). OSHA is also interested in
receiving comments on whether there are any economic implications
associated with including the prescribed concentration ranges.
Appendix B
OSHA is proposing several substantive updates to appendix B (as
outlined in Section XV, Summary and Explanation). These include the
addition of a new hazard class (desensitized explosives) and several
new hazard categories (unstable gases and pyrophoric gases in the
Flammable Gases class and nonflammable aerosols in the Aerosols class).
OSHA has preliminarily determined that the addition of these specific
hazard classes and categories would better differentiate between the
hazards and better communicate hazards on labels for downstream users.
OSHA is requesting comments on whether these changes provide improved
safety through more targeted hazard statements, precautionary
statements and pictograms.
Appendix C
OSHA has proposed numerous changes to appendix C, many of which are
editorial, clarifying, or organizational in nature and are designed to
clarify requirements for preparing labels. The agency is also proposing
some substantive changes to correspond to proposed changes to appendix
B or the regulatory text. In paragraph C.2.4.10, OSHA is proposing to
require prioritization of certain precautionary statements related to
medical response (see Section XV, Summary and Explanation, Appendix C,
Proposed Revisions to Table C.2.4.). The agency requests comments on
the particular system of prioritization specified in proposed C.2.4.10
and on whether the proposed prioritization provisions would improve
clarity on labels.
Appendix D
Many of the issues related to changes proposed for appendix D are
discussed in the summary and explanation of the regulatory text (see
Section XV, Summary and Explanation, Regulatory Text), specifically in
the discussion of OSHA's proposed changes to paragraphs (c), (g), and
(i). OSHA requests comments on the following additional issues:
OSHA is proposing changes to section 2 of the SDS to emphasize that
hazards identified under normal conditions of use that result from a
chemical reaction must appear on the SDS, even though these hazards do
not need to be listed on the label. This proposed change would simply
reorganize the information presented in the SDS, as discussed in
Section XV (Summary and Explanation, Appendix D). OSHA is requesting
comments on whether the text OSHA is proposing for paragraph (c) in
section 2 would clarify when it is appropriate to include information
on the hazards associated with a change in the chemical's physical form
or chemical reaction under normal conditions of use and the type of
information that should be presented in section 2 of the SDS.
With some conditions, the HCS currently requires section 3 of the
SDS to include the chemical name and concentration (exact percentage)
or concentration ranges of all ingredients which are classified as
``health hazards'' in accordance with paragraph (d) of Sec. 1910.1200.
OSHA is not proposing to change this requirement, but is interested in
comments on whether it should be expanded to include all classified
chemicals (i.e., also physical hazards and HNOCSs). Such a requirement
would be similar to the EU REACh regulations, which require SDS
preparers to list the classification of each hazardous ingredient
(ECHA, 2016, Document ID 0177). Would expanding the requirements for
section 3 in this way ensure that both users and manufacturers fully
understand any potential hazard when handling the chemical? Would such
a change result in the provision of additional information that would
allow downstream manufacturers to more accurately classify their
products where the mixture in question is one of their ingredients?
The use of newer electronic technology, such as quick response (QR)
codes and radio-frequency identification (RFID), on package labels give
responsible parties the ability to communicate information on chemical
hazards in a variety of formats. In the December 2018 session of the UN
Sub-committee, the members of an informal working group on labeling of
small containers agreed to extend its scope beyond small containers
and, accordingly, to change its name to ``Practical Labelling Issues.''
Among other activities proposed for the biennium 2019-2020, the working
group planned to ``[r]eview the existing digital means of communication
that can be used to convey the GHS hazard information to users (e.g.,
electronic label, QR code etc.),'' ``consider the development of
general principles and criteria on the provision of this information
digitally,'' and ``develop guidance and examples wherever
appropriate.'' (UN GHS, 2019, Document ID 0198; UN Secretariat, 2019,
Document ID 0196).
As an example, a paper presented at the December 2018 session of
the UN sub-committee noted that there are international efforts
``actively promoting the application of electronic labels for
chemicals'' in such industrial processes as production; management of
cylinders, laboratory samples, and warehouse operations; and the
supervision of competent persons (UN GHS, 2019, Document ID 0198). The
paper noted that common types of electronic labels include QR codes and
RFID. The paper also discussed efforts to develop national standards on
electronic labeling ``to establish a complete integrated information
managing standard system based on chemical electronic labels and safety
data'' in order to ``further ensure the effectiveness of chemical
safety supervision, promote the implementation of the Globally
Harmonized System of Classification and Labelling of Chemicals, and
facilitate . . . trade.'' Among the benefits of practical labeling
cited by the sub-committee expert are the convenience and efficiency
derived from ``unified information collection,'' ``dynamic
management,'' and ``real-time monitoring''; the ability to store a
large capacity of information, reaching multiple mega-byte levels; and
``[improvement in] the level of safety management in complex
scenarios.'' (UN GHS, 2018, Document ID 0082).
OSHA invites comments on the use of electronic labeling for
chemical packaging. If a future revision to the HCS permitted some form
of electronic labeling, what technological, economic, and security
challenges would affected employers face? The agency also requests
comments on the types of electronic chemical labeling already in
existence or under development. For employers already implementing
electronic labeling programs in the United States or in other
countries, please provide information on the types of electronic coding
systems utilized in the program and the costs incurred and benefits
achieved from the program.
[[Page 9690]]
What back-up measures are in place to ensure immediate access to the
hazard information? OSHA is interested in information about workers'
experiences with the use of electronic labels. OSHA also requests
comments on foreseeable challenges that OSHA should consider (e.g.,
worker accessibility to electronic label information).
Preliminary Economic Analysis
(1) As explained in the preliminary economic analysis (see Section
VII.F. Compliance Costs and Cost Savings), some chemical production and
logistics employees who receive training under the provisions of the
existing HCS would need to receive additional training to become
familiar with the updates to SDSs and labels for impacted aerosols,
desensitized explosives, and flammable gases. OSHA has preliminarily
determined that the incremental training costs employers would incur
for these employees will be relatively small (estimated annualized
training costs of $120,158 for all affected employers). OSHA also
believes that users of aerosols, desensitized explosives, and flammable
gases in the workplace are already trained on the hazards of these
chemicals and therefore would need to devote only a trivial amount of
time, if any time at all, to additional training associated with the
reclassification of these chemicals. Per the discussion of this issue
in the preliminary economic analysis (see ``Costs Associated with
Training Employees'' in Section VII.F. Compliance Costs and Cost
Savings), OSHA acknowledges that some user training might be required
for non-flammable aerosols not under pressure; the agency has
preliminarily concluded, however, that such training time would be
negligible given that, as discussed in Section XV.C (see Section XV,
Summary and Explanation for Appendix B), most aerosols are currently
classified as gases under pressure and therefore are already covered
under the HCS. The agency requests comments on all of its preliminary
conclusions regarding training time for users of reclassified
chemicals.
(2) For purposes of estimating the costs associated with the
proposed new hazard classification requirements, OSHA estimates that a
Health & Safety Specialist would spend 1.75 hours per SDS for
establishments with fewer than 100 employees; 1.25 hours per SDS for
establishments with 100-499 employees; and 0.75 hours per SDS for
establishments with 500 or more employees (see ``Costs Associated with
Reclassifications and Revisions to Safety Data Sheets and Labels'' in
Section VII.F, Compliance Costs and Cost Savings). At a loaded hourly
wage of $56.87, this results in estimated unit costs of $101.51,
$72.51, and $43.50 per SDS for small, medium, and large establishments,
respectively. OSHA invites interested parties to comment on these
estimates.
(3) For purposes of estimating the costs associated with revising
labels and SDSs to conform to the revisions OSHA is proposing to
mandatory language in the appendices, OSHA estimates that a Health &
Safety Specialist would spend 0.7 hours per SDS for establishments with
fewer than 100 employees; 0.5 hours per SDS for establishments with
100-499 employees; and 0.3 hours per SDS for establishments with 500 or
more employees (see ``Revisions to SDSs and Labels Due to Revised
Precautionary Statements,'' in Section VII.F. Compliance Costs and Cost
Savings). At a loaded hourly wage of $56.39, this results in estimated
unit costs of $40.60, $29.00, and $17.40 per SDS for small, medium, and
large establishments, respectively. OSHA invites interested parties to
comment on these estimates.
(4) To estimate the costs (cost savings) associated with the
proposed released-for-shipment provisions in paragraph (f)(11), OSHA
presented a cost methodology that required estimating four factors: (1)
Cost savings (estimated relabeling costs) as a percentage of the value
of the products needing relabeling; (2) the percentage of products in
the affected NAICS industries that would be warehoused for more than
six months; (3) the percentage of products warehoused for more than six
months that would require relabeling in any particular year due to a
manufacturer-initiated labeling change; \58\ and (4) the percentage of
all products in the NAICS industries that would be covered by the
proposed revisions to the HCS. The estimated percentages are shown in
Table VI-17: Calculation of the Percentage Loss Avoided Due to the
Proposed Released-for-Shipment Provision. OSHA requests public comments
on its estimates for each of the four factors described above and shown
in Table VI-17.
---------------------------------------------------------------------------
\58\ That is, a labeling change resulting from new information
obtained by the manufacturer and not from a new legal requirement.
---------------------------------------------------------------------------
(5) As described in the PEA (see ``Released for Shipment'' in
Section VII.F. Compliance Costs and Cost Savings), OSHA anticipates
that the proposed modifications to paragraph (f)(11) addressing
chemicals that have been released for shipment would result in cost
savings for manufacturers and distributors of certain products--those
with large (and typically infrequent) production runs and lengthy shelf
lives (often five years or longer) that, during production, are
labeled, boxed, palletized, and shipped, and then go through the
distribution chain usually without the chemical contents, packaging, or
label being disturbed. OSHA identified six industries (NAICS 325311
Nitrogenous fertilizer manufacturing, NAICS 325312 Phosphatic
fertilizer manufacturing, NAICS 325314 Fertilizer (mixing only)
manufacturing, NAICS 325510 Paint and coating manufacturing, NAICS
424910 Farm supplies merchant wholesalers, and NAICS 424950 Paint,
varnish, and supplies merchant wholesalers) that it expects would be
impacted by the proposed modifications to paragraph (f)(11); see Table
VI-17 in Section VII.D. Health and Safety Benefits and Unquantified
Positive Economic Effects. OSHA invites comments on whether other
industries would be affected by this proposed modification and whether
there might be other cost or health effects resulting from this
proposed modification that OSHA did not consider in this proposal.
(6) Also with respect to the estimate of cost savings associated
with the proposed released-for-shipment provisions, OSHA assumes that
if the relabeling costs associated with paragraph (f)(11) exceed the
value of the product, manufacturers and wholesalers will discard the
product rather than pay to relabel it. There may be some disposal costs
for the discarded material, but there may also be some salvage value to
the improperly-labeled product. In the preliminary economic analysis
(see ``Released for Shipment'' in Section VII.F. Compliance Costs and
Cost Savings), OSHA estimates, without further information on the
distribution of the costs, that the average labeling cost is
approximately 50 percent of the value of the products requiring
relabeling. The agency invites comments on this assumption.
B. Options
In this section, OSHA presents a list of options that are under
consideration for the proposed update to the HCS. The agency is
requesting public comment on these options.
Regulatory Text
(1) OSHA is proposing, in paragraph (i), to mandate the use of
prescriptive concentration ranges whenever an actual concentration or
concentration range is being claimed as a trade secret. This change is
being proposed, in part, to better align with Canada's Workplace
[[Page 9691]]
Hazardous Materials Information System (WHMIS), allowing manufacturers,
importers, and employers the ability to use the same SDS for both U.S.
and Canadian workplaces. However, the agency is also considering a non-
mandatory option for this provision. Under this scenario, OSHA would
provide non-mandatory guidance on the use of concentration ranges, but
would not require their use. This would allow manufacturers, importers,
and employers flexibility to follow the current HCS requirements (which
do not require the use of any concentration ranges when the actual
concentration is claimed as a trade secret) or move to a system that
aligns with WHMIS. OSHA is requesting comments on this option. Would
this option provide beneficial flexibility to manufacturers, importers,
and employers? Would this option be too confusing, and potentially
weaken protective effects that would be associated with providing
prescribed concentration ranges? How would this affect employee safety
and comprehension?
(2) Under paragraph (i), OSHA is also considering allowing
manufacturers and importers to provide their own ranges as long as the
range is narrower than any prescribed range. This alternative could
allow manufacturers and importers to provide downstream users with more
precise information while still being able to claim a trade secret.
This would be consistent with an approach Health Canada is considering
(Canada, 2019, Document ID 0172). OSHA is seeking comments on the
usefulness and viability of this option.
Revision 8 Changes
The GHS Rev. 8 was published in July 2019 and contains many changes
from Rev. 7, including updates to certain hazard classification
criteria, systematic updates to the definitions in the health hazard
chapters, updates to hazard and precautionary statements, and updated
labeling examples. An overview of the changes can be found in Document
ID 0243. As discussed more thoroughly in the introduction to the
Summary and Explanation (see Section XV), OSHA has preliminarily
decided to use this proposed update to align the HCS with the GHS Rev.
7. However, OSHA has also identified specific updates found in the GHS
Rev. 8 that are significant enough to warrant consideration in this
rulemaking. Below, the agency highlights several updates from the GHS
Rev. 8 and invites public comments on whether OSHA should consider
adopting these updates.
1. Appendix A (Based on the GHS Rev. 8)
OSHA is proposing substantial revisions to appendix A.2 (skin
corrosion/irritation) that reflect changes the UN subcommittee adopted
through the GHS Rev. 7. However, the GHS Rev. 8, published in July 2019
(UN GHS, 2019, Document ID 0065), expanded the use of non-animal test
methods in Chapter 3.2 (skin corrosion/irritation). These changes
include recognition of specific in vitro test methods, reorganization
of the chapter, reorganization of the tiered approach with an updated
Figure 3.2.1 to reflect those changes, as well as descriptive text on
use of new test methods, structure activity relationship (SAR) and read
across methods, and an updated decision logic diagram. The expansion of
non-animal test methods for use in hazard classification could
potentially result in cost savings, as hazard testing for new chemicals
could be done using potentially cheaper (non-animal) test methods. If
OSHA were to adopt these changes, they would be reflected in appendix
A.2 Skin Corrosion/Irritation.
BILLING CODE 4510-26-P
[[Page 9692]]
[GRAPHIC] [TIFF OMITTED] TP16FE21.079
BILLING CODE 4510-26-C
Table 3.2.1 from the GHS Rev. 8 (shown above) provides an update to
the tiered approach for classification. In recognition of the
advancements made in non-animal test methods, the update includes an
elevation in acceptance of in vitro data to tier 2 of the approach. The
updated tiered approach also includes consideration of conflicting
lower-tiered data when the lower tier suggests a higher classification
level. In addition to the changes in the table, Rev. 8 updates the
background information to provide additional guidance for how to use
non-animal test data to classify chemicals. Adopting these updates in
the HCS would not require a re-evaluation of chemicals already
classified because the overall tiered approach for evaluating existing
data has been retained. The agency believes the greatest benefit would
be for new chemicals where no existing data currently exists. Although
OSHA does not require testing, OSHA currently encourages chemical
manufacturers wanting to develop hazard information for new chemicals
to utilize non-animal testing strategies to develop hazard information.
Should OSHA adopt Chapter 3.2 from the GHS Rev. 8 with all of the
revisions to the classification scheme? Please explain your opinion and
provide any relevant data or other information.
2. Appendix B (Based on the GHS Rev. 8)
In this NPRM, OSHA is proposing updates to the classification and
labeling of aerosols that will align with the GHS Rev. 7. However, the
GHS Rev. 8 contains several significant additional changes in the
aerosol chapter. OSHA requests comments on whether the agency should
adopt two specific changes that appear in the GHS Rev. 8. First, the
GHS Rev. 8 lists classification criteria for aerosols as text in a
table (see the GHS table 2.3.1, Criteria for aerosols), similar to
other hazard chapters, rather than referring classifiers to the
decision logics. When OSHA revised the HCS in 2012, the agency declined
to adopt the GHS decision logics and used its own text for
classification of flammable aerosols (Sec. 1910.1200, appendix B).
OSHA has preliminarily determined that there are no substantive
differences between OSHA's current text and the text
[[Page 9693]]
represented in the new Rev. 8 table (reproduced below), although they
do not contain exactly the same language (UN GHS, Rev. 8, Document ID
0065).
Table XIV--Rev. 8 Classification Criteria for Aerosols
[From the GHS Rev. 8 Table 2.3.1]
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ (1) Any aerosol that contains >=85% flammable
components (by mass) and has a heat of
combustion of >=30 kJ/g;
(2) Any aerosol that dispenses a spray that,
in the ignition distance test, has an
ignition distance of >=75 cm; or
(3) Any aerosol that dispenses a foam that,
in the foam flammability test, has:
(a) a flame height of >=20 cm and a flame
duration of >=2 s; or
(b) a flame height of >=4 cm and a flame
duration of >=7 s.
2........................ (1) Any aerosol that dispenses a spray that,
based on the results of the ignition
distance test, does not meet the criteria
for Category 1, and which has:
(a) A heat of combustion of >=20 kJ/g;
(b) a heat of combustion of <20 kJ/g along
with an ignition distance of >=15 cm; or
(c) a heat of combustion of <20 kJ/g and an
ignition distance of <15 cm along with
either, in the enclosed space ignition test:
A time equivalent of <=300 s/m3; or
a deflagration density of <=300 g/m3; or
(2) Any aerosol that dispenses a foam that,
based on the results of the aerosol foam
flammability test, does not meet the
criteria for Category 1, and which has a
flame height of >=4 cm and a flame duration
of >=2 s.
3........................ (1) Any aerosol that contains <=1% flammable
components (by mass) and that has a heat of
combustion <20 kJ/g; or
(2) Any aerosol that contains >1% (by mass)
flammable components or which has a heat of
combustion of >=20 kJ/g but which, based on
the results of the ignition distance test,
the enclosed space ignition test or the
aerosol foam flammability test, does not
meet the criteria for Category 1 or Category
2.
------------------------------------------------------------------------
Should OSHA adopt the classification criteria for the aerosols
hazard class as presented above? While the criteria themselves would
not change as compared to OSHA's existing standard, adopting the
precise language in the GHS text may minimize confusion.
Second, in Rev. 8, the GHS adopted a new hazard category within the
aerosols class: Chemicals under pressure (UN GHS, 2019, Document ID
0065; UN GHS, 2018, Document ID 0247; UN GHS, 2018, Document ID 0248).
These products function similarly to aerosol dispensers (UN 1950), but
are packed in pressure receptacles (refillable and non-refillable) up
to 450 liters ((UN GHS, 2019, Document ID 0065; UN TDG, 2020, Document
ID 0195). Chemicals under pressure used for spray applications present
hazards that are similar to those presented by aerosol dispensers.
Therefore, the classification criteria and hazard information are the
same as for aerosols. OSHA recognizes that adopting this hazard
classification would bring some chemicals under the purview of the HCS
that currently are not covered (e.g., certain aerosols in refillable
containers). Should OSHA consider adopting the new hazard category of
chemicals under pressure in the aerosol chapter?
3. Appendix C (Based on the GHS Rev. 8)
In this NPRM, OSHA is proposing to update a number of precautionary
statements to align with the GHS Rev. 7. However, the GHS Rev. 8
includes additional revisions to precautionary statements, most notably
an overhaul of the medical response precautionary statements (UN GHS,
2019, Document ID 0065). These precautionary statements were revised
for the GHS Rev. 8 because, among other reasons, manufacturers and
suppliers had difficulty choosing the appropriate wording where options
were given (e.g., choosing between calling a poison center or doctor,
or choosing between medical advice or attention) (UN GHS, 2019,
Document ID 0065).
Table XV--Revised Medical Response Statements From the GHS Rev. 8
----------------------------------------------------------------------------------------------------------------
Response precautionary
Code statements Hazard class Hazard category Conditions for use
----------------------------------------------------------------------------------------------------------------
P316............. Get emergency medical Acute toxicity, oral 1, 2, 3............... Competent Authority
help immediately. (chapter 3.1). 1, 2, 3............... or manufacturer/
Acute toxicity, dermal 1, 2, 3............... supplier may add,
(chapter 3.1). 1, 1A, 1B, 1C......... `Call' followed by
Acute toxicity, the appropriate
inhalation (chapter emergency telephone
3.1). number, or the
Skin corrosion appropriate
(chapter 3.2). emergency medical
help provider, for
example, a Poison
Centre, Emergency
Centre or Doctor.
Respiratory 1, 1A, 1B.............
sensitization
(chapter 3.4).
Specific target organ 1, 2..................
toxicity, single
exposure; (chapter
3.8).
Aspiration hazard 1, 2..................
(chapter 3.10).
P317............. Get medical help...... Gases under pressure Refrigerated liquefied
(chapter 2.5). gas.
Acute toxicity, oral 4, 5..................
(chapter 3.1).
Acute toxicity, dermal 4, 5..................
(chapter 3.1).
Acute toxicity, 4, 5..................
inhalation (chapter
3.1).
Skin irritation 2, 3..................
(chapter 3.2).
Serious eye damage 1.....................
(chapter 3.3).
Eye irritation 2/2A, 2B..............
(chapter 3.3).
Skin sensitization 1, 1A, 1B.............
(chapter 3.4).
P318............. If exposed or Germ cell mutagenicity 1, 1A, 1B, 2..........
concerned, get (chapter 3.5).
medical advice.
Carcinogenicity 1, 1A, 1B, 2..........
(chapter 3.6).
[[Page 9694]]
Reproductive toxicity 1, 1A, 1B, 2..........
(chapter 3.7).
Reproductive toxicity, Additional category...
effects on or via
lactation (chapter
3.7).
P319............. Get medical help if Specific target organ 3.....................
you feel unwell. toxicity, single
exposure; respiratory
tract irritation
(chapter 3.8).
Specific target organ 3.....................
toxicity, single
exposure; narcotic
effects (chapter 3.8).
Specific target organ 1, 2..................
toxicity, repeated
exposure (chapter
3.9).
----------------------------------------------------------------------------------------------------------------
As the new statements used in the GHS Rev. 8 provide standardized
language and do not require manufacturers and suppliers to decide which
statement is most appropriate, adopting these statements in the HCS as
part of this rulemaking might save manufacturers or importers time and/
or money compared to the existing statements. OSHA also believes that
these statements could improve hazard communication and worker safety
by more effectively conveying the type of medical action that is
necessary. OSHA seeks comments on the potential benefits or drawbacks
associated with adopting these revised medical response statements, or
other precautionary statements that are part of the GHS Rev. 8, as a
part of this rulemaking (see also Summary and Explanation, Section
XV.D. Appendix C). OSHA's existing enforcement policy, as described in
the OSHA hazard communication directive (OSHA, 2015, Document ID 0007),
addresses situations in which employers may use precautionary
statements from a more recent version of the GHS; does the policy
described in the directive provide sufficient flexibility?
Incorporation by Reference
OSHA is proposing to revise the general incorporation by reference
section, 29 CFR 1910.6, to include updated test methods referenced in
the proposed revisions to the HCS. OSHA does not intend to require
chemicals already classified using an earlier version of a consensus
standard to be reclassified. OSHA believes that requiring the
reclassification of chemicals based on updated test methods could
result in unnecessary economic impacts and create unnecessary confusion
for stakeholders. OSHA is considering ways to clarify this in the final
regulatory text, e.g., by including a provision in the Dates section of
the rule stating that chemicals classified based on older test methods,
prior to the effective date of the rule, do not need to be
reclassified, and invites comments on this topic.
XV. Summary and Explanation of the Proposed Modifications to the Hazard
Communication Standard
This section of the preamble explains OSHA's proposed changes to
the HCS (29 CFR 1910.1200). OSHA is proposing to align this
modification of the HCS with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060). The agency has preliminarily decided to base most of the GHS
alignment on Rev. 7 for several reasons, even though Rev. 8 of the GHS
was issued in July 2019 (UN GHS, 2019, Document ID 0065). First, OSHA
began its work to update the standard prior to the release of Rev. 8.
While OSHA has always intended the HCS to be evergreen, preparation for
amending any standard is a time-consuming process and changing course
would have resulted in a significant delay to this rulemaking. Second,
the U.S.'s major trading partners (Canada, Europe, Australia, and New
Zealand) are all preparing to align with Rev. 7 (Canada, 2019, Document
ID 0172; Australia, 2020, Document ID 0168; New Zealand, 2018, Document
ID 0187; EC, 2019, Document ID 0176). Third, OSHA has discussed the
potential for adopting some of the most consequential changes from Rev.
8 in the Issues and Options section (see Section XIV, Issues and
Options Considered).
In general, OSHA has received broad support for this rulemaking.
During OSHA's informal discussion with stakeholders in November 2016
about the potential changes to the HCS (Docket No. OSHA-2016-005), the
agency received feedback supporting continued alignment of the HCS with
the GHS and Health Canada, as well as support for addressing various
implementation issues under the existing HCS (API, 2016, Document ID
OSHA-2016-0005-0026; ACC, 2016, Document ID OSHA-2016-0005-0014; NGFA,
2016, Document ID OSHA-2016-0005-0018; AFIA, 2016, Document ID OSHA-
2016-0005-0017). The proposed changes are intended to improve and
enhance worker protection with regard to hazard communication by
incorporating new hazard classes and categories, improving and
streamlining precautionary statements, and providing additional
clarification of existing regulatory requirements. The following is a
discussion, by provision, of the proposed revisions to the standard.
In the discussion of the proposed modifications to the appendices,
OSHA describes certain proposed changes that would affect multiple
hazard classes. OSHA discusses some changes in general terms and
indicates where those changes occur. However, to aid stakeholders, so
they can see the proposed changes in context, OSHA is placing in the
docket and on its website a redline strikeout version of all of the
proposed revisions to the current HCS and appendices (OSHA HCS Redline,
2020, Document ID 0222; https://www.osha.gov/dsg/hazcom/).
A. Incorporation by Reference
OSHA is proposing to update the general incorporation by reference
section, 29 CFR 1910.6, to include the national/international consensus
standards listed below. OSHA does not intend to require chemicals
already classified using an earlier version of a consensus standard to
be reclassified. OSHA believes that requiring the reclassification of
chemicals based on updated test methods could result in unnecessary
economic impacts and create unnecessary confusion for stakeholders.
OSHA is considering ways to clarify this in the final regulatory text,
e.g., by including a provision in the DATES section of the rule stating
that chemicals classified based on older test methods, prior to the
effective date of the rule, do not need to be reclassified, and invites
comments on this topic.
In places where OSHA is proposing to cite to new or updated
national/international consensus standards in the regulatory text and
appendix B, OSHA
[[Page 9695]]
is proposing to include the title, edition/version, and year of the
standard in the relevant reference for the benefit of stakeholders and
for ease of compliance. OSHA is not currently proposing to add/update
all existing references to consensus standards in the regulatory text
and appendix B, but recognizes that in some places in the existing text
consensus standards are cited without specific reference to the year,
edition, or full title of the relevant standard. In such cases,
stakeholders need to consult with Sec. 1910.6 to find more details
regarding the specific consensus standard that has been incorporated by
reference in the HCS. For example, appendix B, Section B.6.3 (Flammable
Liquids), incorporates by reference ASTM D1078, and Sec. 1910.6
specifies that the version of that standard incorporated by reference
is the one approved on May 15, 2005. Since there are many versions of
ASTM D1078 available, OSHA realizes that the general reference to ASTM
D1078 in appendix B could cause confusion to those classifying new
chemicals. OSHA is requesting comments on whether additional
information (year, edition/version, full title) should be added to all
of the references to consensus standards that are already incorporated
by reference in the HCS.
OSHA is proposing to incorporate by reference (in Sec. 1910.6) the
materials below. A brief description of each consensus standard is
provided in the text below. A description of their use can be found in
the Regulatory Text, Appendices, and Summary and Explanation for the
Regulatory Text and Appendices (see Section XV.A and D) where the
standard is referenced. Each standard is available for purchase through
the publication agencies listed below:
Regulatory Text--Paragraph c (Definitions)
[cir] ASTM D 4359-90 (2019)--Standard Test Method for Determining
Whether a Material is a Liquid or a Solid, Re-approved 2019: This
consensus standard provides specific details regarding the test methods
used to determine whether a viscous material is a liquid or solid.
[ssquf] ASTM, International: https://astm.org/Standard/standards-and-publications.html.
[cir] European Agreement Concerning the International Carriage of
Dangerous Goods by Road (ADR): This consensus standard provides test
methods for determining the specific physical characteristics of a
liquid.
[ssquf] https://shop.un.org/series/european-agreement-concerning-international-carriage-dangerous-goods-road-adr.
Appendix B.1.3--Explosives
[cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport
of Dangerous Goods, Manual of Tests and Criteria, Part I: This
consensus standard provides test methods to determine if a substance
has explosive properties, the degree of sensitivity of the explosive
properties, and stability of explosive properties. The consensus
standard also provides information on the procedures for classification
of explosive materials.
[ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
Appendix B.2.3--Flammable Gases
[cir] ISO 10156:2010, Gases and Gas Mixtures--Determination of Fire
Potential and Oxidizing Ability for the Selection of Cylinder Valve
Outlets, Third Edition, April, 2010: This consensus standard provides
specific details of the methods used to determine flammability of a gas
or gas mixture. The standard also provides methods for determining if a
gas or gas mixture is more or less oxidizing than air under atmospheric
conditions. The intention of the standard is for classifying gases and
gas mixtures as flammable gases and can be used to select the
appropriate gas cylinder valve outlet for the flammability
classification.
[ssquf] International Organization for Standards; https://iso.org/store.html.
[cir] ISO 817:2014 Refrigerants--Designation and safety
classification: This consensus standard establishes a safety
classification system based on the toxicity and flammability of the
refrigerant. It also provides guidance on how to determine a
refrigerant concentration limit.
[ssquf] International Organization for Standards; https://iso.org/store.html.
[cir] IEC 60079-20-1 ed. 1.0 (2010-01) Explosive atmospheres--Part
20-1: Material characteristics for gas and vapor classification--Test
methods and data: This consensus standard provides guidance for
classification of gas-air mixtures and vapor-air mixtures under normal
conditions of pressure/temperature while also providing guidance on the
appropriate selection of equipment. In addition, the standard provides
guidance for determining the auto-ignition temperature of gas-air
mixtures and vapor-air mixtures with additional information provided to
guide selection of appropriate equipment for use in hazardous areas.
[ssquf] International Electrotechnical Commission: https://iec.ch/index/htm#buy.
[cir] DIN 51794 Determining the ignition temperature of petroleum
products: This consensus standard provides detailed information on test
methods used to determine the ignition temperature of petroleum
products. The standard applies to flammable gases and liquids in a
specific range of ignition temperature (75-650 [deg]C) with particular
emphasis on mineral oils hydrocarbons and their mixtures,
[ssquf] German Institute of Standards: https://din.de/en/about-standards/buy-standards.
[cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport
of Dangerous Goods, Manual of Tests and Criteria, Part III: This
standard provides test methods for determining the flammability of
aerosols and gases. The standard provides additional information on the
criteria used in classifying gases with regards to their flammability.
[ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
Appendix B.4--Oxidizing Gases
[cir] ISO 10156: 2010, Gases and Gas Mixtures--Determination of
Fire Potential and Oxidizing Ability for the Selection of Cylinder
Valve Outlets, Third Edition, April, 2010: This consensus standard
provides specific details of the methods used to determine flammability
of a gas or gas mixture. The standard also provides methods for
determining if a gas or gas mixture is more or less oxidizing than air
under atmospheric conditions. The standard provides information on
criteria that may be used for classifying gases and gas mixtures as
flammable gases and may be used to select the appropriate gas cylinder
valve outlet for the flammability classification.
[ssquf] https://www.iso.org/store.html.
Appendix B.14.2--Oxidizing Solids
[cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport
of Dangerous Goods, Manual of Tests and Criteria, Part III: This
section of the standard provides detailed test methods for determining
the potential of a solid substance to increase the burning potential or
burning intensity of a combustible substance when the two are
thoroughly mixed. The standard also provides schematic with criteria on
classifying solid substances based on the oxidizing potential.
[ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
Appendix B.17.2--Desensitized Explosives
[cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport
of
[[Page 9696]]
Dangerous Goods, Manual of Tests and Criteria, Part V: This section of
the Manual identifies criteria for classification of desensitized
explosives, and addresses the proper storage of these substances. The
standard provides testing criteria and guidance on classifying,
storing, and properly transporting goods according to their physical
hazards.
[ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
[cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport
of Dangerous Goods, Manual of Tests and Criteria, Part II: This
standard provides information on the definition of desensitized
explosives, the test methods used to evaluate a substance's ability to
suppress its explosive properties when thoroughly mixed as a homogenous
liquid and provides the criteria used to classify these substances
based on their desensitizing properties.
[ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
Appendix B.17.3--Desensitized Explosives
[cir] UN ST/SG/AC.10/30/Rev.6, UN Recommendations on the Transport
of Dangerous Goods, Manual of Tests and Criteria, Part II: This
standard provides information on the definition of desensitized
explosives, the test methods used to evaluate a substance's ability to
suppress its explosive properties when thoroughly mixed as a homogenous
liquid and provides the criteria used to classify these substances
based on their desensitizing properties.
[ssquf] https://www.unece.org/tans/danger/publi/manual/maual_e.html.
The proposed inclusion of UN ST/SG/AC.10/30/Rev.6, UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests
and Criteria, in some sections of appendix B (B.1, B.2, B.3, B.4, B.14,
and B.17) would align with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060). However, an earlier version of UN ST/SG/AC.10 (Rev. 4) was
incorporated by reference as part of the 2012 rulemaking and OSHA is
not currently proposing to update all of the Rev. 4 references to Rev.
6 as part of this rulemaking. OSHA requests comments on whether it
should, in the final rule, update all of the existing references to UN
ST/SG/AC.10/30 to Rev.6 or add Rev. 6 references to the existing Rev. 4
references such that they would be alternative options for compliance.
UN ST/SG/AC.10/Rev.4 is included in the proposed regulatory text as
part of the revision to the structure of Sec. 1910.6(bb).
Copies of the standards are available for purchase from the issuing
organizations at the addresses or through the other contact information
listed in Sec. 1910.6 for these private standards organizations. The
UN documents are available at no cost through the contact information
listed above. In addition, in accordance with Sec. 1910.6(a)(4), these
standards are available for inspection at any Regional Office of the
Occupational Safety and Health Administration (OSHA), or at the OSHA
Docket Office, U.S. Department of Labor, 200 Constitution Avenue NW,
Room N-3508, Washington, DC 20210; telephone: 202-693-2350 (TTY number:
877-889-5627). Due to copyright issues, OSHA cannot post consensus
standards on the OSHA website or through regulations.gov.
B. Regulatory Text
OSHA has proposed numerous revisions to the HCS regulatory text.
The discussion of the proposed modifications is organized by paragraphs
to the regulatory text with each modification/addition, and the reasons
for and anticipated impact of each, described in detail below.
Stakeholders can examine the redline strikeout version of the
regulatory text at the OSHA HCS web page (https://www.osha.gov/dsg/hazcom/) or in the docket of this rulemaking (OSHA, 2020, Document ID
0222).
Paragraph (a) Purpose
Existing paragraph (a)(1) of the HCS states that the purpose of the
standard is to ensure that the hazards of all chemicals produced or
imported are classified, and that information concerning the classified
hazards is transmitted to employers and employees. This provision
currently explains that the requirements of the standard are intended
to be consistent with the GHS Rev. 3. As the changes in this proposal
would align the HCS with the GHS Revision 7, OSHA proposes to change
the reference from Rev. 3 to Rev. 7.
Paragraph (b) Scope and Application
The scope section of the HCS identifies the chemicals that are (and
are not) covered by the standard. Existing paragraph (b)(6)(x) excludes
nuisance particulates from the standard where the chemical manufacturer
or importer can establish that they do not pose any physical or health
hazard covered by the standard. OSHA proposes a slight revision to this
provision to make clear that nuisance particulates are excluded if they
do not pose any physical hazard, health hazard, or other hazards (i.e.,
hazard not otherwise classified (HNOC)) covered by the standard. This
proposal would clarify that all hazards covered by the standard must be
considered when evaluating nuisance particulates.
Paragraph (c) Definitions
OSHA proposes to update three existing definitions and to add eight
new terms and definitions to the HCS. In addition, the agency is
proposing to eliminate one definition from the standard.
OSHA is proposing to add a definition of the term Bulk Shipment to
the standard. The addition of this definition supports proposed
paragraph (f)(5)(ii), which clarifies labeling requirements for bulk
shipments of hazardous chemicals. The proposed definition would state
that ``bulk shipment'' means any hazardous chemical transported where
the mode of transportation (vehicle) comprises the immediate container
(e.g., contained in tanker truck, rail car, or intermodal container).
OSHA is proposing to add the term Combustible Dust to the standard.
In updating the HCS in 2012, OSHA did not include a definition of
combustible dust because the agency was considering a combustible dust
rulemaking and the UNSCEGHS was also considering combustible dust
classification and communication issues (see 77 FR at 17705). However,
OSHA has not promulgated a combustible dust standard. Since 2012, the
UNSCEGHS has adopted a definition; the GHS Rev. 7 defines combustible
dust as ``finely divided solid particles of a substance or mixture that
are liable to catch fire or explode on ignition when dispersed in air
or other oxidizing media'' (definition adopted from ISO/IEC 80079-20-2
as referenced in UN GHS, 2017, Document ID 0060). OSHA has
preliminarily determined that this definition is consistent with
existing OSHA guidance on combustible dust hazards and proposes to
adopt this definition (OSHA, 2020, Document ID 0190; OSHA, 2009,
Document ID 0255). OSHA has several standards that use the term
``combustible dust,'' but do not define the term (e.g., Sec. 1910.272,
Grain Handling Facilities). OSHA believes the proposed definition of
the term for the HCS is consistent with the use of that term in those
other standards.
OSHA is also proposing to revise the definition of exposure or
exposed. The definition currently provides, in relevant part, that
exposure or exposed means that an employee is subjected in the course
of employment to a chemical that is a physical or health hazard. OSHA
proposes to revise the definition to mean an employee is subjected in
the course of employment to a ``hazardous chemical,'' rather than to
``a chemical
[[Page 9697]]
that is a physical or health hazard,'' to clarify that the HCS covers
the hazards of all hazardous chemicals, including those considered to
be HNOCs.
OSHA is proposing to include three new definitions for the terms
Gas, Liquid, and Solid. The agency is proposing to include these terms
to align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060). Although
not included in the GHS, OSHA is proposing to add the temperature in
equivalent degrees Fahrenheit and pressure in equivalent pounds per
square inch (PSI) to the GHS definitions of gas and liquid because
those measurements are more commonly used in the U.S.
Consistent with the GHS, OSHA proposes to define gas as a substance
which (i) at 122 [deg]F (50 [deg]C) has a vapor pressure greater than
43.51 PSI (300 kPa) (absolute); or (ii) is completely gaseous at 68
[deg]F (20 [deg]C) at a standard pressure of 14.69 PSI (101.3 kPa).
Also consistent with the GHS, OSHA proposes to adopt the definition of
liquid as a substance or mixture which at 1220F (50 [deg]C) has a vapor
pressure of not more than 43.51 PSI (300 kPa (3 bar)), which is not
completely gaseous at 680F (20 [deg]C) and at a standard pressure of
101.3 kPa, and which has a melting point or initial melting point of 68
0F (20 [deg]C) or less at a standard pressure of 14.69 PSI (101.3 kPa).
Furthermore, in accordance with the GHS, OSHA is proposing to include
the following as part of the definition of liquid: A viscous substance
or mixture for which a specific melting point cannot be determined
shall be subjected to ASTM D4359-90 (the Standard Test Method for
Determining Whether a Material Is a Liquid or a Solid (2019)); or to
the test for determining fluidity (penetrometer test) prescribed in
section 2.3.4 of Annex A of the European Agreement concerning the
International Carriage of Dangerous Goods by Road (ADR, 2019). Finally,
OSHA proposes to adopt the GHS definition of solid as a substance or
mixture which does not meet the definitions of liquid or gas.
Although OSHA did not include these terms in the 2012 update to the
HCS, the agency is now proposing to include these definitions in order
to improve clarity and ensure consistency in hazard communication both
domestically and internationally. The agency anticipates that including
these terms in the standard will clarify provisions under appendices B
and D for classification of hazardous chemicals and preparation of
SDSs. OSHA does not anticipate that these new definitions will impact
other existing standards for construction or general industry. OSHA is
requesting comments on its preliminary decision to include these
definitions in this update.
OSHA is proposing to update the definition of hazardous chemical to
delete the reference to pyrophoric gas because OSHA is proposing to
classify this hazard as a physical hazard in the flammable gas hazard
class (see discussion of proposed revisions to appendix B.2) and it is
no longer necessary to list it separately in the definition.
Concomitantly, OSHA is proposing to delete the separate definition for
pyrophoric gas.
OSHA proposes to add a definition for immediate outer package to
mean the first packaging enclosing the container of hazardous chemical.
While all containers of chemicals must be labeled, as discussed in the
Summary and Explanation for paragraph (f), below, OSHA is proposing
revised labeling requirements for small containers. Proposed paragraph
(f)(12) would relax labeling requirements for small containers, but
would require complete label information on the ``immediate outer
package.'' For example, in the case of a kit, the container would be
whatever surrounds the chemical itself (e.g., a vial), and the
immediate outer package would be the first box or package surrounding
the container.
The agency is also proposing to update the definition of physical
hazard to mean a chemical that is classified as posing one of the
following hazardous effects: Explosive; flammable (gases, liquids, or
solids); aerosols; oxidizer (liquid, solid or gas); self-reactive;
pyrophoric (liquid or solid); self-heating; organic peroxide; corrosive
to metal; gas under pressure; in contact with water emits flammable
gas; or desensitized explosive. The proposed definition also explicitly
states that the criteria for determining whether a chemical is
classified as a physical hazard are detailed in appendix B of the
standard. The proposal would make two substantive changes to the
current definition: (1) It would move the reference to aerosols out of
the parenthetical following the word ``flammable''; and (2) it would
add a reference to desensitized explosives. These proposed revisions
are intended to reflect the proposed new hazard classes for aerosols
and desensitized explosives in appendix B in accordance with the GHS
Rev. 7. These changes are discussed in greater detail in the Summary
and Explanation of appendix B.
OSHA is proposing to add a definition of Physician or other
licensed health care professional (PLHCP) to the standard. OSHA
proposes to define this term as an individual whose legally permitted
scope of practice (i.e., license, registration, or certification)
allows the individual to independently provide or be delegated the
responsibility to provide some or all of the health care services
referenced in paragraph (i) of the standard. The new definition is
necessary in light of OSHA's proposal to replace the phrase ``physician
and nurse'' in paragraph (i), trade secrets with the term ``PLHCP'' to
be consistent with other OSHA standards that use the term PLHCP, and to
better reflect current medical practices. That change is discussed in
greater detail in the Summary and Explanation of paragraph (i). OSHA
believes the proposed definition of ``PLHCP'' is consistent with the
way the agency has defined that term in all health standards
promulgated since the bloodborne pathogen standard, 29 CFR 1910.1030,
in 1991.
OSHA is also proposing to add a new definition, released-for-
shipment, to mean a chemical that has been packaged and labeled in the
manner in which it will be distributed or sold. This is a new term OSHA
is proposing to use in paragraphs (f)(1) and (11) related to updating
labels when new hazard information becomes available. OSHA notes that
this definition is similar, but not identical to, the definition used
by the U.S. Environmental Protection Agency's (EPA's) Pesticide
Registration and Classification Procedures regulation, 40 CFR 152.3.
EPA defines a product as released for shipment when the producer has
packaged and labeled it in the manner in which it will be distributed
or sold, or if it is stored in an area where finished products are
ordinarily held for shipment. OSHA is not proposing to include
chemicals that are stored in an area where finished products are
usually held (but not packaged and labeled) in the definition of
``released for shipment'' because there do not appear to be any
feasibility issues with ensuring that such chemicals are labeled with
the most updated information. The agency is requesting comments on
whether the proposed definition is appropriate for application to the
HCS. OSHA is also interested in understanding whether the slight
differences between OSHA's and EPA's definitions will pose any
compliance issues for entities dealing with both OSHA and EPA labeling
requirements. See the discussion of the proposed revisions to paragraph
(f) for additional details.
Paragraph (d) Hazard Classification
OSHA is proposing two changes to paragraph (d)(1). OSHA proposes to
revise the second sentence of paragraph
[[Page 9698]]
(d)(1) to read that for each chemical, the chemical manufacturer or
importer shall determine the hazard classes, and where appropriate, the
category of each class that apply to the chemical being classified
under normal conditions of use and foreseeable emergencies. The
language OSHA is proposing to add at the end of that sentence (``under
normal conditions of use and foreseeable emergencies'') simply
reiterates the scope language currently in paragraph (b)(2) and OSHA's
longstanding position that hazard classification must cover the normal
conditions of use and foreseeable emergencies. As OSHA explained in its
compliance directive for the HCS (OSHA, 2015, Document ID 0007), for
example, known intermediates, by-products, and decomposition products
that are produced during normal conditions of use or in foreseeable
emergencies must be addressed in the hazard classification.
OSHA also proposes to add a new sentence to paragraph (d)(1)
stating that the hazard classification shall include any hazards
associated with a change in the chemical's physical form or resulting
from a reaction with other chemicals under normal conditions of use.
OSHA believes this language is necessary because there has been some
confusion about whether chemical reactions that occur during normal
conditions of use must be considered during classification. The
agency's intent has always been to require information on SDSs that
would identify all chemical hazards that workers could be exposed to
under normal conditions of use and in foreseeable emergencies (see
paragraph (b)(2)). This issue has been raised, for instance, when
multiple chemicals are sold together with the intention that they be
mixed together before use. For example, epoxy syringes contain two
individual chemicals in separate sides of the syringe that are mixed
under normal conditions of use. While OSHA intends for the hazards
created by the mixing of these two chemicals to be considered in
classification, those hazards need only appear on the SDS (see appendix
D to Sec. 1910.1200--Safety Data Sheets, section 3) and not on the
label. For additional information, please see the Summary and
Explanation for appendix D.
Paragraph (e) Written Hazard Communication Plan
OSHA is proposing a minor editorial correction in paragraph (e)(4).
OSHA has found that an inadvertent misprint occurred in the print
version of the CFR. Specifically, in the print version of the CFR,
paragraph (e)(4) references Sec. 1910.20 instead of Sec. 1910.1020.
Notably, this error is reflected only in the print version of the CFR;
the eCFR (www.ecfr.gov) is correct. OSHA proposes to fix this error so
that the print and electronic versions of the standard are the same.
Paragraph (f) Labels and Other Forms of Warning
Paragraph (f) of the HCS provides requirements for labeling. OSHA
is proposing to modify paragraphs (f)(1), (5), and (11), and is also
proposing a new paragraph (f)(12).
Paragraph (f)(1), Labels on shipped containers, currently specifies
what information is required on shipped containers of hazardous
chemicals and also provides that HNOCs do not have to be addressed on
the containers. OSHA proposes to revise paragraph (f)(1) to provide
that, in addition to HNOCs, hazards resulting from a reaction with
other chemicals under normal conditions of use do not have to be
addressed on shipped containers. OSHA believes this information is not
appropriate on containers because it might confuse users about the
immediate hazards associated with the chemical in the container.
However, information on hazards resulting from a reaction with other
chemicals under normal conditions of use is important for downstream
users, and OSHA is not proposing to change the existing requirements
for these hazards to be indicated on SDSs (under appendix D) and
addressed in worker training where applicable (under paragraph (h)).
OSHA also proposes to add the word ``distributor'' to the third
sentence of paragraph (f)(1) to make it consistent with the first
sentence.
In new paragraph (f)(1)(vii), OSHA is proposing to add a
requirement that the label include the date a chemical is released for
shipment. The agency is proposing this change in conjunction with
changes in paragraph (f)(11) related to relabeling of containers that
are released for shipment but have not yet been shipped. Providing the
date a chemical is released for shipment on the label would allow
manufacturers and distributors to more easily determine their
obligations when new hazard information becomes available.
Paragraph (f)(5) specifies label requirements that apply to the
transport of hazardous chemicals from workplace to workplace. OSHA
proposes to add the heading ``Transportation'' to this paragraph and to
add two new paragraphs to (f)(5) that specify requirements related to
transportation of hazardous chemicals.
OSHA is proposing to add new paragraph (f)(5)(ii) to address the
transport of bulk shipments of hazardous chemicals (e.g.,, in tanker
trucks or rail cars). The proposed paragraph would specify that labels
for bulk shipments of hazardous chemicals may either be on the
immediate container or may be transmitted with shipping papers, bills
of lading, or other technological or electronic means so that the
information is immediately available in print to workers on the
receiving end of the shipment. The proposed paragraph would codify
policy from a 2016 guidance document that OSHA created jointly with
DOT's Pipeline Hazardous Materials Safety Administration (PHMSA), with
the intent of providing stakeholders with clarity for how to properly
label bulk chemicals in transport (PHMSA, 2016, Document ID 0244). OSHA
requests comments on whether it is appropriate to add proposed
paragraph (f)(5)(ii) to the HCS and whether the addition of that
paragraph would provide clarity regarding labeling of bulk chemical
shipments.
Under the current HCS, appendix C, paragraph C.2.3.3 provides that
where a pictogram required by the DOT appears on a shipped container,
the HCS pictogram for the same hazard (specified in C.4) shall not
appear. This provision was intended to prevent confusion associated
with having two different representations of the same hazard on the
container (77 FR 17728). However, after learning that DOT updated its
regulations to indicate that it does not consider the HCS pictogram to
conflict with the DOT pictogram, OSHA no longer believes that having
both pictograms will create confusion for workers handling the
chemical. Accordingly, OSHA proposes to: (1) Delete the language
currently in paragraph C.2.3.3 from appendix C; and (2) adopt new
paragraph (f)(5)(iii) to provide that where a DOT pictogram appears on
a label for a shipped container, the appendix C pictogram for the same
hazard is allowed, but is not required, on the HCS label.
For example, in the case where a chemical is shipped in only its
immediate container, such as a 55-gallon drum containing a flammable
liquid, both a DOT label and an OSHA-compliant label would be required.
Under the current standard, the flame pictogram on the OSHA-compliant
label would be prohibited because the DOT label would contain the
equivalent pictogram. The proposed rule would allow, but not require,
the flame pictogram to appear on the OSHA-compliant label. This means
chemical
[[Page 9699]]
manufacturers could use the same labels for shipping containers and for
containers that are solely used in the workplace; this would avoid
information loss and eliminate the need to develop or print additional
labels.
Paragraph (f)(11) currently requires that chemical manufacturers,
importers, distributors, or employers who become newly aware of any
significant information regarding the hazards of a chemical revise the
labels within six months of becoming aware of the new information and
ensure that labels on containers of hazardous chemicals shipped after
that time contain the new information. OSHA recognizes that, on some
occasions, a chemical manufacturer or importer may become aware of
significant hazard information after a chemical has already been
labeled but before it ships. Therefore, OSHA proposes to add a sentence
to paragraph (f)(11) providing that chemicals that have been released
for shipment and are awaiting future distribution need not be
relabeled; however, the proposed sentence also states that the chemical
manufacturer or importer must provide the updated label for each
individual container with each shipment. The purpose of this proposal
is to account for the long distribution cycles of some products and the
potential hazards workers could face in relabeling the immediate
containers of hazardous chemicals that have already been prepared for
shipment.
Following publication of the 2012 updates to the HCS, OSHA received
feedback related to difficulties some chemical manufacturers were
having complying with paragraph (f)(11), particularly in the case of
chemicals that travel through long distribution cycles (Kenyon, 2017,
Document ID 0182). Many products have straightforward supply chains and
are packaged, labeled, and promptly shipped downstream. Other products,
for example in the agrochemical sector, are packaged and labeled when
they leave the chemical manufacturer's facility, but they may reside at
a warehouse or distribution facility for extended periods of time
(e.g.,, several years) before being shipped downstream. There are also
instances where products may be returned from the downstream users to
the distribution facility and then shipped to other customers (NGFA,
2016, Document ID OSHA-2016-0005-0018; AFIA, 2016, Document ID OSHA-
2016-0005-0017).
The act of relabeling these products in warehouses or distribution
facilities has the potential to pose occupational safety and health
risks to employees. Relabeling each individual container may require
that employees open already secure packaging, a process that may result
in potential chemical exposures. Furthermore, OSHA believes re-labeling
of sealed hazardous chemical containers is not a common practice in
warehouses and that warehouses may lack the equipment necessary to
relabel products in a safe and effective manner.
OSHA has previously recognized the complexities involved with
relabeling existing stock of hazardous chemicals. Following
promulgation of the 2012 updates to the HCS, the HCS compliance
directive (OSHA, 2015, Document ID 0007) provided enforcement guidance
on the labeling of existing stock. Before June 1, 2015 (for
manufacturers and importers), and before December 1, 2015 (for
distributors), OSHA permitted chemical manufacturers, importers, and
distributors with existing stock that was packaged (e.g.,, boxed,
palletized, shrink wrapped, etc.) for shipment and labeled in
accordance with the pre-2012 version of the HCS to ship those
containers downstream without relabeling the containers with HCS 2012-
compliant labels. However, the chemical manufacturer or importer
generally had to provide an HCS 2012-compliant label for each
individual container shipped and the appropriate HCS 2012-compliant
SDS(s) with each shipment. After June 1, 2015, chemical manufacturers
and importers of hazardous chemicals were required to ensure that each
container was labeled with an HCS 2012-compliant label prior to
shipping, and all distributors were generally required to ensure any
chemicals shipped after December 1, 2015, were labeled in accordance
with the 2012 updates to the HCS. OSHA used this enforcement policy as
a basis for the proposed revisions to paragraph (f)(11).
OSHA has preliminarily determined that the proposed changes to
paragraph (f)(11) would adequately address issues with long
distribution cycles while still ensuring chemical users receive the
most current hazard information. OSHA invites comments on the proposed
revisions to this paragraph. In particular, OSHA requests comments on
whether the proposed changes would adequately address issues associated
with relabeling in cases of long distribution cycles, whether the
proposed changes would provide sufficient flexibility, and whether the
proposed revisions would alleviate safety concerns that would otherwise
be associated with the relabeling of packaged stock.
OSHA is proposing a new paragraph, (f)(12), to address small
container labeling. Currently, the HCS requires that all shipped
containers be labeled with the information specified in paragraph
(f)(1). The HCS, as updated in 2012, requires considerably more
information on the label than the standard required previously; labels
must include all hazards, as well as pictograms and precautionary
statements. Many stakeholders have told OSHA that they have
difficulties including all of the required information from paragraph
(f)(1) on the labels they use for small containers. In some cases, the
information becomes too small for a person to read it, and while it is
sometimes possible to use alternate types of labels (such as pull-out
labels or tags), it is not always feasible to do so (Watters, 2013,
Document ID 0200; Collatz, 2015, Document ID 0174; Blankfield, 2017,
Document ID 0170). In response to these concerns, through letters of
interpretation and the HCS directive (OSHA, 2015, Document ID 0007;
Watters, 2013, Document ID 0200; Collatz, 2015, Document ID 0174;
Blankfield, 2017, Document ID 0170), OSHA provided a practical
accommodation to address situations where it is infeasible to provide
all HCS-required label information directly on small containers through
the use of pull-out labels, fold-back labels, or tags. The practical
accommodation allows limited information to be included on the small
container label, but requires complete label information to be provided
on the outside packaging. OSHA proposes to incorporate this practical
accommodation into the standard in new paragraph (f)(12).
OSHA is proposing that all of the small container labeling
provisions apply only where the chemical manufacturer, importer, or
distributor can demonstrate that it is not feasible to use pull-out
labels, fold-back labels, or tags containing the full label information
required by paragraph (f)(1). Proposed paragraph (f)(12)(ii)(A) through
(E) would provide that labels on small containers that are less than or
equal to 100 milliliter (ml) capacity must include, at minimum: Product
identifier; pictogram(s); signal word; chemical manufacturer's name and
phone number; and a statement that the full label information for the
hazardous chemical is provided on the immediate outer package.
Additionally, proposed paragraph (f)(12)(iii) would provide that no
labels are required for small containers of 3 ml capacity or less where
the chemical manufacturer, importer, or distributor can demonstrate
that any label would interfere with the normal use of the container;
however,
[[Page 9700]]
that same proposed paragraph would state that if no label is required,
the container must bear, at minimum, the product identifier. For
example, the product identifier (e.g., CAS number) could be etched on a
3 ml glass vial (container) to ensure that the identifier remains fixed
to the vial. This type of identification would ensure that the chemical
in the small container can be identified and matched with the
chemical's full label information.
Proposed paragraph (f)(12)(iv) would provide that for any small
container covered by paragraph (f)(12)(ii) or (iii), the immediate
outer package must include the full label information required by
paragraph (f)(1) for each hazardous chemical in the immediate outer
package, along with a statement that the small container(s) inside must
be stored in the immediate outer package bearing the complete label
when not in use. This proposed paragraph would also state that labels
affixed to the immediate outer package must not be removed or defaced,
as required by existing paragraph (f)(9).
OSHA believes that proposed paragraph (f)(12) would provide
chemical manufacturers, importers and distributors with flexibility in
labeling small containers. The proposed paragraph is consistent with
the small packaging examples provided in the GHS Annex 7: Examples of
Arrangements of the GHS Label Elements (UN GHS, 2016, Document ID
0197), and would result in better alignment with Health Canada's
Hazardous Product Regulations (HPR) small capacity container
requirements (Health Canada, 2015, Document ID 0051). Specifically, the
HPR, under 5.4(1), provides exemptions from certain labeling
requirements (such as precautionary statements) for small capacity
containers of 100 ml or less. In addition, under 5.4(2), the HPR
provides labeling exemptions for containers of 3 ml or less if the
label interferes with the normal use of the hazardous product. OSHA
requests comments on the feasibility of the proposed small container
labeling provisions. The agency also requests feedback about whether
the proposed changes would improve safe handling and storage for
chemicals in small containers.
Paragraph (g) Safety Data Sheets
SDSs provide important safety information to employers and
employees on the use of hazardous chemicals in the workplace.
Additionally, SDSs provide detailed technical information and serve as
a reference source for exposed employees, industrial hygienists, safety
professionals, emergency responders, health care professionals, and
other interested parties. While OSHA believes that information in SDSs
has greatly improved with the standardized, 16-section format
prescribed in the 2012 updates to the HCS, the agency is proposing two
minor changes to paragraph (g) to ensure consistency and accessibility
of the SDSs.
The proposed revisions to paragraph (g) are confined to paragraphs
(g)(2) and (10). The purpose of paragraph (g)(2) is to identify what
information must be included on an SDS. The first part of existing
paragraph (g)(2) states that the chemical manufacturer or importer
preparing the SDS shall ensure that it is in English. However, as
permitted by paragraph (g)(1), some chemical manufacturers and
importers may obtain, rather than prepare, SDSs. To minimize any
potential confusion between paragraphs (g)(1) and (2), OSHA is
proposing to revise paragraph (g)(2) by removing the reference to
preparing the SDS. The first part of the first sentence in paragraph
(g)(2) would be revised to read simply that the chemical manufacturer
or importer shall ensure that the SDS is in English. This is a
technical clarification intended to ensure consistency with paragraph
(g)(1).
Paragraph (g)(10) addresses the form and storage of SDSs. The
original intent of paragraph (g)(10) was to allow employers
alternatives to SDSs within a plant site (see 48 FR 53337).
Alternatives to SDSs, such as written operating procedures and manuals,
are generally permitted. Existing paragraph (g)(10) also permits
employers to design SDSs to cover groups of hazardous chemicals in a
work area where it may be more appropriate to address the hazards of a
process rather than individual chemicals. In any case, paragraph
(g)(10) requires the employer to ensure that the required information
is provided for each hazardous chemical and is readily accessible to
employees. However, with the update to the HCS in 2012, OSHA changed
the requirements of the SDS from a performance-oriented format to a
standardized format. Standardizing the SDS format improved hazard
communication by ensuring users could quickly find relevant information
(see 77 FR 17596-98). Because SDSs now have a standardized format and
are specific to individual hazardous chemicals, they are not permitted
to be designed to cover groups of hazards, as currently provided in
paragraph (g)(10). Therefore, OSHA is proposing a change to paragraph
(g)(10) that would allow SDSs to be stored, rather than designed, in a
way to cover groups of hazardous chemicals in a work area. OSHA
believes that this change would allow employers flexibility in how they
keep SDSs in the workplace while also ensuring that the mandatory 16-
section SDS is maintained. The agency is requesting comments regarding
whether this proposed revision would require stakeholders to make any
significant changes to their current practices.
Paragraph (i) Trade Secrets
This paragraph describes certain conditions under which a chemical
manufacturer, importer, or employer may withhold the specific chemical
identity (e.g., chemical name), other specific identification of a
hazardous chemical, or the exact percentage (concentration) of the
substance in a mixture, from the SDS. OSHA is proposing three
significant changes within paragraph (i)(1) and the paragraphs
thereunder. First, OSHA is proposing to revise paragraph (i)(1) to
allow for concentration ranges to be claimed as a trade secret and to
specify that it is section 3 of the SDS from which trade secret
information may be withheld.
Second, OSHA is proposing new paragraph (i)(1)(iv), which would
require that when an ingredient's exact concentration or concentration
range is claimed as a trade secret, the SDS must provide the
ingredient's concentration as a concentration range selected from a
prescribed list of ranges. These ranges are in proposed paragraphs
(i)(1)(iv)(A) through (M) as follows: (1) From 0.1% to 1%; (2) from
0.5% to 1.5%; (3) from 1% to 5%; (4) from 3% to 7%; (5) from 5% to 10%;
(6) from 7% to 13%; (7) from 10% to 30%; (8) from 15% to 40%; (9) from
30% to 60%; (10) from 45% to 70%; (11) from 60% to 80%; (12) from 65%
to 85%; and (13) from 80% to 100%. These ranges are consistent with
those used in Canada, first described under the WHMIS 1988 Controlled
Products Regulation (CPR) and re-implemented in 2018 under the HPR
(Canadian Gazette II, 2018, Document ID 0101). Using the same
concentration ranges as Canada, one of the U.S.'s major trading
partners, is part of the two countries' efforts through the Regulatory
Cooperation Council to align hazard communication to the greatest
extent possible.
OSHA has received numerous inquiries about the use of trade secrets
for concentration ranges (Colau, 2017, Document ID 0098; Nelson, 2017,
Document ID 0099). Although chemical manufacturers and importers are
permitted to use concentration ranges rather than an exact percentage
on the
[[Page 9701]]
SDS when there is batch-to-batch variability in the production of a
mixture or for a group of substantially similar mixtures with similar
chemical composition, OSHA does not currently allow trade secret status
for a concentration range (see 77 FR 17731). However, in response to
feedback from stakeholders who have indicated that there are instances
where a concentration range is also a trade secret, OSHA has
preliminarily determined it is appropriate to permit concentration
ranges to be claimed as trade secrets as long as the ranges prescribed
in proposed paragraphs (i)(1)(iv)(A) through (M) are used (Nelson,
2017, Document ID 0099; Colau, 2017, Document ID 0098).
Third, proposed new paragraph (i)(1)(v) would require that the
concentration range used on the SDS be the narrowest range possible.
This proposed paragraph would also provide that if the actual
concentration range falls between 0.1% and 30% and does not fit
entirely into one of the prescribed ranges in proposed paragraphs
(i)(1)(iv)(A) through (G), a single range created by the combination of
two applicable consecutive ranges between (i)(1)(v)(A) and (G) may be
disclosed instead, provided that the combined concentration range does
not include any range that falls entirely outside the exact range in
which the ingredient is present. For example, a chemical manufacturer
that wishes to claim the concentration of a specific ingredient (e.g.,
2.5%) as a trade secret would have to use the prescribed range in
proposed paragraph (i)(1)(iv)(C) of 1% to 5%. If the ingredient is in
the mixture at a concentration range of 0.9% to 2%, then the chemical
manufacturer could combine the prescribed ranges in proposed paragraphs
(i)(1)(iv)(B) and (C), resulting in a range of 0.5% to 5% on the SDS.
If the ingredient is in the mixture at a concentration range of 5% to
7%, the chemical manufacturer would have to use the range in proposed
paragraph (i)(1)(iv)(D) of 3% to 7%, because it is narrower than the
range in proposed paragraph (i)(1)(iv)(E) of 5% to 10%.
OSHA is requesting comments on the proposed revisions to paragraph
(i)(1). Specifically, the agency is interested in any experience
stakeholders have had with developing SDSs using the prescribed
concentration ranges and any concerns stakeholders have about using
concentration ranges on SDSs. The agency is also requesting comments
addressing the adequacy of hazard information provided by these ranges.
Do these ranges provide sufficient information for downstream chemical
manufacturers to conduct hazard classifications? Are the ranges listed
in proposed paragraphs (i)(1)(iv)(A) through (M) too wide (should they
be narrowed)? Should OSHA allow combinations among all ranges (e.g.,
(i)(1)(v)(A) through (M)) or should the allowance for combining ranges
be even more restrictive than proposed (e.g., (i)(1)(v)(A) through
(E))?
OSHA is also proposing other changes in paragraph (i) to reflect
the proposal to permit concentration ranges to be claimed as trade
secrets and to adopt the ``PLHCP'' terminology in lieu of references to
``physician or nurse.'' See discussion of proposed changes to paragraph
(c), Definitions, where OSHA explains that it is proposing to replace
the phrase ``physician and nurse'' with ``PLHCP'' to be consistent with
other OSHA standards and to better reflect current medical practices.
The specific changes OSHA is proposing are as follows:
OSHA is proposing to revise paragraph (i)(1)(iii) to
change ``percentage'' to ``concentration or concentration range.''
OSHA is proposing to move existing paragraph (i)(1)(iv) to
paragraph (i)(1)(vi) and to change ``percentage'' to ``exact
concentration or concentration range.''
In paragraph (i)(2), OSHA is proposing to change
``physician or nurse'' to ``PLHCP'' and to replace ``percentage of
composition'' with ``concentration or concentration range.''
OSHA is proposing to revise paragraph (i)(3) to change
``percentage composition'' to ``exact concentration or concentration
range'' and to change the parenthetical from ``(i.e., physician,
industrial hygienist, toxicologist, epidemiologist, or occupational
health nurse)'' to ``(e.g., PLHCP, industrial hygienist, toxicologist,
or epidemiologist).''
Paragraph (j) Dates
OSHA is proposing to implement the revised provisions over a two-
year phase-in period. OSHA proposes that the revisions become effective
60 days after the publication date (paragraph (j)(1)) and that chemical
manufacturers, importers, and distributors evaluating substances comply
with all modified provisions of the HCS no later than one year after
the effective date (paragraph (j)(2)). OSHA also proposes that chemical
manufacturers, importers, and distributors evaluating mixtures comply
with all modified provisions no later than two years after the
effective date (paragraph (j)(3)).
Proposed paragraph (j) would replace the regulatory text currently
in paragraph (j), as the dates specified in existing paragraph (j) have
all passed. This proposed paragraph is based in part on stakeholder
comments and the agency's experience implementing the 2012 updates to
the HCS. In 2012, OSHA did not stagger the compliance dates for
substances and mixtures; however, OSHA believes that such a tiered
approach may ease the compliance burden for manufacturers of mixtures
that may rely on the hazard information in the SDSs from their
ingredient suppliers to update the labels and SDSs for the mixtures.
The changes OSHA is proposing in this update are far less complicated
than the 2012 revision and would result in no change in hazard
classification for the vast majority of chemicals. Additionally, the
proposed update to paragraph (f)(11) addressing relabeling requirements
for chemicals that have been released for shipment would also reduce
the need for a lengthier implementation period. OSHA is requesting
comments regarding the adequacy and appropriateness of the proposed
compliance dates and on the feasibility of implementing a tiered
compliance approach for substances and mixtures.
C. Appendix A
OSHA is proposing to update appendix A in several respects. The
proposed changes are discussed in order of revisions to specific health
hazards in appendix A, followed by general changes to definitions and
terminology, clarification of mandatory requirements, and corrections.
OSHA preliminarily concludes that all of the proposed changes to
appendix A will improve classification and communication of hazards and
thus better protect workers. Many of the proposed changes would align
the HCS with the GHS Rev. 7. Aligning the HCS with the GHS would ease
compliance burdens for U.S. stakeholders who must also comply with
international requirements for hazard classification and communication.
OSHA is providing a redline strikeout version of appendix A, which
reflects all of OSHA's proposed revisions, in the docket and on the
OSHA website (OSHA HCS Redline, 2020, Document ID 0222; https://www.osha.gov/dsg/hazcom/). This will allow interested parties to view
all of the proposed changes in context. OSHA strongly encourages
stakeholders to review that document in conjunction with the discussion
of the proposed revisions below, as the discussion below does not fully
describe all of the non-substantive or editorial changes OSHA is
proposing.
[[Page 9702]]
Revisions to Health Hazards in Appendix A
General Classification Considerations
In Paragraph A.0.1, OSHA proposes to add a note from Paragraph
1.3.3.1.3 of the GHS Rev. 7 (UN GHS, 2017, Document ID 0060), providing
that where impurities, additives, or individual constituents of a
substance or mixture have been identified and are themselves
classified, they should be taken into account during classification if
they exceed the cut-off value/concentration limit for a given hazard
class. OSHA did not include this note in the HCS in 2012 because the
definition of ``substance'' in paragraph (c) references additives and
impurities, and therefore the classification of substances necessarily
takes impurities and additives into account. Nonetheless, the agency
now believes that this note is useful to align with the GHS and has
added this note as proposed A.0.1.3. Including this provision would
clarify that manufacturers and importers must consider the hazards of
all classified components when classifying chemicals. This would help
ensure accurate classification of chemicals and therefore improve
protections for workers.
OSHA also proposes to modify the introduction of paragraph A.0.4.1
to include mandatory language. The current text indicates that the
sequence in the process of classification of mixtures is recommended.
OSHA proposes to revise A.0.4.1 to read ``Except as provided in
A.0.4.2, the process of classification of mixtures is based on the
following sequence'' to specify that this process is mandatory.
Acute Toxicity--(Appendix A.1)
In appendix A.1, OSHA proposes to revise the definition of acute
toxicity to refer to serious adverse health effects (i.e., lethality)
occurring after a single or short-term oral, dermal, or inhalation
exposure to a substance or mixture. (The current definition refers to
adverse effects occurring following oral or dermal administration of a
single dose of a substance, or multiple doses given within 24 hours, or
an inhalation exposure of 4 hours.) This change is being proposed to
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2016, Document ID 0131).
OSHA also proposes to revise the classification criteria for
substances in A.1.2.1 to note that while some in vivo methods determine
LD50/LC50 values directly, other newer in vivo
methods (e.g., using fewer animals) consider other indicators of acute
toxicity, such as significant clinical signs of toxicity, which are
used by reference to assign the hazard category. This change is being
proposed to align with classification criteria in the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2016, Document ID 0131).
OSHA is also proposing slight revisions to Table A.1.1, ``Acute
toxicity hazard categories and acute toxicity estimate (ATE) values
defining the respective categories'', to align with the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2016, Document ID 0131). The GHS
presents the ATE range in Table A.1.1 using the term ``ATE'' to express
the range, while the HCS currently uses the term ``AND.'' Therefore,
OSHA proposes to change the ``AND'' in the acute toxicity estimate
(ATE) ranges to ``ATE'' to align with the GHS Rev. 7. This modification
would not change the classification criteria itself, but would be more
technically accurate and consistent with the way the table is expressed
in the European Commission's (EC) Classification, Labelling, and
Packaging of Substances and Mixtures (CLP) regulation (ECHA, 2017,
Document ID 0256).
In paragraph A.1.2.3, OSHA proposes to include a new sentence at
the end of the paragraph to clarify that both data from animal tests
and human studies should be considered in evaluating acute toxicity.
The new text states that in cases where data from human experience
(i.e., occupational data, data from accident databases, epidemiology
studies, clinical reports) is also available, it should be considered
in a weight of evidence approach consistent with the principles
described in A.0.3. To ensure human data is considered in classifying
chemicals for all acute toxicity hazard categories, the GHS added this
clarifying text in paragraph 3.1.2.3 (UN GHS, 2016, Document ID 0131).
OSHA is proposing these changes to paragraph A.1.2.3 to align with the
GHS Rev. 7.
OSHA also proposes a new paragraph A.1.2.4, which is intended to
correspond to Chapter 3.1, (paragraph 3.1.2.6.5) in the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060). This proposed paragraph would provide
that in addition to classification for inhalation toxicity, if data are
available that indicate that the mechanism of toxicity was corrosivity
of the substance or mixture, the classifier must consider whether the
chemical is corrosive to the respiratory tract. This proposed paragraph
would clarify that the hazard corrosive to the respiratory tract is
covered under the HCS. OSHA did not explicitly include the corrosive to
the respiratory tract hazard in the HCS in 2012, but explained in OSHA
3844: Hazard Communication: Hazard Classification Guidance for
Manufacturers, Importers and Employers (OSHA, 2016, Document 0008) that
this hazard should be considered during classification. The Hazard
Classification guidance explains that if the classifier has data
indicating that there is acute inhalation toxicity with corrosion of
the respiratory tract that leads to lethality, then the substance or
mixture may be labeled with the additional hazard statement ``corrosive
to the respiratory tract.'' However, if the classifier has data that
indicates acute inhalation toxicity with corrosion of the respiratory
tract and the effect does not lead to lethality, then the hazard may be
addressed in the Specific Target Organ Toxicity hazard classes (see
appendices A.8 and A.9). OSHA is including these clarifications in
proposed A.1.2.4.1 and A.1.2.4.2, but is modifying the ``may'' language
from the guidance to ``must'' language to ensure that corrosive to the
respiratory tract is appropriately considered during the classification
process.
In Figure A.1.1 and paragraph A.1.3.6.2.2, OSHA proposes to correct
the cross-reference from A.1.3.6.2.3 to A.1.3.6.2.4. OSHA also proposes
to amend paragraph A.1.3.6.2.3. If a mixture contains an ingredient of
unknown acute toxicity at a concentration of at least 1 percent,
paragraph A.1.3.6.2.3 currently requires a statement that ``X'' percent
of a mixture consists of ingredient(s) of unknown toxicity on the label
and SDS. OSHA proposes to revise this paragraph to require the
statement to differentiate by route of exposure. For example, the
statement(s) could read, ``x % of the mixture consists of ingredient(s)
of unknown acute oral toxicity'' or ``x % of the mixture consists of
ingredient(s) of unknown acute dermal toxicity.'' Given that it is
possible to have unknown ingredients for more than one relevant route
of exposure (e.g., oral, dermal, inhalation), differentiating the
statement by route would be helpful to chemical users. This proposed
change would align with paragraph 3.1.3.6.2.2 in the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2010, Document 0089).
OSHA also proposes to delete the second paragraph in A.1.3.6.2.3
because it is duplicative of the first paragraph.
Skin Corrosion/Irritation and Serious Eye Damage/Eye Irritation--
(Appendices A.2 and A.3)
OSHA is proposing more extensive revisions to the sections on skin
corrosion/irritation and serious eye
[[Page 9703]]
damage/irritation (appendices A.2 and A.3) than it is proposing for the
other health hazard sections in appendix A of the HCS. These two
sections correspond to Chapters 3.2 and 3.3 in the GHS. The UNSCEGHS,
in its 16th Session, assembled an informal working group to review the
content of Chapters 3.2 and 3.3 in the GHS, and to propose editorial
revisions in order to enhance clarity and user-friendliness in the
application of the criteria (UN GHS, 2016, Document 0131). The group's
primary focus was to change the order of the text to ensure that the
classification strategy was clear, and to change the testing scheme to
more of an evaluation scheme, since the GHS, like the HCS, is test
method neutral. The work of the informal working group was not complete
before OSHA published its updates to the HCS in 2012. The working group
has since completed its efforts to clarify the skin corrosion/
irritation and serious eye damage/irritation chapters. The work was
approved by the UNSCEGHS in 2012 (UN GHS, 2012, Document ID 0212).
Accordingly, OSHA is now proposing to revise appendices A.2 and A.3 to
incorporate all of the modifications that were made to the GHS skin
corrosion/irritation and serious eye damage/irritation chapters agreed
to by the UNSCEGHS up to and including the GHS Rev. 7. This would
ensure that OSHA remains aligned with the GHS. OSHA is not proposing
any completely new provisions for the HCS; however, OSHA is proposing
to revise the two appendices to align the language and format of the
HCS with the GHS Rev. 7.
In appendix A.2, skin corrosion/irritation, OSHA proposes to modify
paragraph A.2.1.2 to clarify the sequence in which data should be
evaluated when classifying for skin corrosion/irritation using a tiered
evaluation approach. The proposal would align the language in this
paragraph with the tiered approach in Figure A.2.1. The first tier is
existing human data, followed by existing animal data, followed by in
vitro data, and then other sources of information.
The proposed changes to the skin corrosion/irritation criteria in
paragraph A.2.2 are mainly editorial in nature. The classification
criteria would remain the same, but the presentation of the information
would be rearranged in a clearer, more logical fashion. In addition,
OSHA is proposing new paragraph A.2.2.2.2, which is intended to provide
classifiers with factors to be taken into consideration when evaluating
irritant responses.
The proposed changes in paragraph A.2.3 are also mainly editorial
in nature. The criteria would remain the same, but clarifying text
would be introduced into the section and the criteria would be
presented in a more logical sequence.
OSHA also proposes to include a new note to Table A.2.3,
``Concentration of ingredients of a mixture classified as skin Category
1 or 2 that would trigger classification of the mixture as hazardous to
skin (Category 1 or 2),'' to indicate how to classify the mixture when
data are available for sub-categorization of Category 1. The proposed
note would align with the note to Table 3.2.3 in the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0132), and OSHA
believes that it provides useful information for classifiers.
Figure A.2.1, ``Tiered evaluation of skin corrosion and irritation
potential'', would remain largely the same under OSHA's proposed
revisions to the appendix. However, OSHA is proposing to revise the
title to ``Tiered evaluation for skin corrosion and irritation.'' OSHA
is also proposing to revise Steps 1a, 1b, and 1c of Figure A.2.1 to
clarify that the parameter being evaluated is existing human or animal
skin corrosion/irritation data. In addition, OSHA is proposing to
modify the finding in Step 4 to clarify that high acid/alkaline reserve
or no data for acid/alkaline reserve should be considered when the pH
is <=2 or >=11.5. OSHA is also proposing some revisions to the
footnotes of Figure A.2.1.
In proposed footnote (1), OSHA is proposing to revise the
current footnote to include an additional sentence indicating that
although human data from accident or poison center databases can
provide evidence for classification, absence of incidents is not itself
evidence for a not classified determination. In addition, the reference
to evidence from ethically-conducted human clinical studies would be
removed. The text indicating that there is no internationally accepted
test method for human skin irritation testing would also be removed.
In proposed footnote (3), OSHA is proposing to revise the
existing note to exclude the examples currently provided.
In proposed footnote (6), OSHA is proposing to revise the
current note to clarify that all available information on a substance
must (instead of should) be considered in making a determination based
on the total weight of evidence. OSHA is also proposing a new sentence
at the end of the footnote to indicate that negative results from
applicable validated skin corrosion/irritation in vitro tests are
considered in the total weight of evidence evaluation.
In paragraph A.2.4, OSHA is proposing to include in A.2.4.1.1
language stating that the tiered approach must be taken into account
when evaluating mixtures. In addition, a new paragraph A.2.4.1.2 is
proposed to indicate that when considering testing of mixtures,
classifiers must use the tiered approach to help ensure an accurate
classification, as well as to avoid unnecessary animal testing. This
proposed paragraph also indicates that if there are no other data on
the mixture besides pH, and the pH is extreme (pH <=2 or pH >=11.5),
that information is sufficient to classify the mixture as corrosive to
the skin. However, if the acid/alkaline reserve suggests that the
mixture may not be corrosive despite the extreme pH, then further
evaluation may be necessary.
In Table A.2.4, ``Concentration of ingredients of a mixture for
which the additivity approach does not apply, that would trigger
classification of the mixture as hazardous to skin,'' OSHA proposes to
delete the phrase ``for which additivity does not apply'' where it
appears in the text of the table in order to reduce redundancy, as that
language is already included in the title of the table. However, OSHA
is proposing to modify the title of Table A.2.4 from ``for which
additivity does not apply'' to ``when additivity does not apply'' to be
consistent with the GHS Rev.7 (UN GHS, 2017, Document ID 0060).
In appendix A.3, serious eye damage/eye irritation, OSHA proposes
to modify A.3.1.2 to clarify the sequence in which data should be
evaluated when classifying for serious eye damage/eye irritation using
a tiered evaluation approach. The proposal would align the language in
this paragraph with the tiered approach in Figure A.3.1. The first tier
is existing human data, followed by existing animal data, followed by
in vitro data, and then other sources of information.
The changes OSHA is proposing in paragraphs A.3.2 and A.3.3,
including Tables A.3.1 and A.3.2, are mainly editorial in nature. The
classification criteria in these paragraphs would remain the same, but
the presentation of the information would be rearranged and additional
headings would be included to provide a clearer, more logical sequence.
All of these proposed changes would conform with the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2012, Document 0132).
Proposed paragraph A.3.2 provides a summary of the classification
criteria for substances that is provided in Tables A.3.1 and A.3.2. In
addition, proposed paragraph A.3.3.6 is a reorganization of existing
paragraphs A.3.3.3 and A.3.3.4.
[[Page 9704]]
It would provide guidance on using the tiered approach and making
weight of evidence decisions and also indicates a preference for not
conducting new animal tests.
Under OSHA's proposed revisions, Figure A.3.1, ``Tiered Evaluation
for serious eye damage and eye irritation'', currently titled
``Evaluation strategy for serious eye damage and eye irritation'',
would remain largely the same. However, as in Figure A.2.1, OSHA is
proposing to revise Steps 1a, 1b, and 1c to clarify that the parameter
being evaluated is existing human or animal serious eye damage/eye
irritation data. In addition, OSHA is proposing to modify the finding
in Step 4 to clarify that high acid/alkaline reserve or no data for
acid/alkaline reserve should be considered when the pH is <=2 or
>=11.5. OSHA is also proposing modifications to the footnotes of Figure
A.3.1 to reflect the most recent test methods.
In proposed footnote (3), OSHA is proposing to include an
additional sentence that emphasizes that expert judgement should be
exercised when making determinations from existing animal data
indicating serious eye damage/eye irritation, as not all skin irritants
are eye irritants.
In proposed footnote (4), OSHA is proposing to include
OECD Test Guideline 460 (Fluorescein leakage (FL) as an additional
example of an internationally accepted, scientifically validated test
method for identifying eye corrosives and severe irritants. OSHA is
also proposing an additional sentence for this footnote to indicate
that there are presently no scientifically validated and
internationally accepted in vitro test methods for identifying eye
irritation.
In proposed footnote (6), OSHA is proposing to revise
existing language to make it clear that all available information on a
substance must (instead of should) be considered in making a
determination based on the total weight of evidence. In addition, OSHA
is proposing to add two new sentences at the end of the footnote to
indicate that the total weight of evidence, including information on
skin irritation, may lead to classification for eye irritation and that
negative results from applicable scientifically validated in vitro
tests are considered in the total weight of evidence evaluation.
In paragraph A.3.4, OSHA is proposing several minor editorial
changes to ensure consistency in the terminology used. For example,
OSHA is proposing to use the term ``serious eye damage'' (rather than
``eye corrosion'') throughout the text to reflect the name of the
hazard class.
Germ Cell Mutagenicity--(Appendix A.5)
OSHA is proposing to add a definition for germ cell mutagenicity in
A.5.1.1 explaining that germ cell mutagenicity refers to heritable gene
mutations, including heritable structural and numerical chromosome
aberrations in germ cells occurring after exposure to a substance or
mixture. OSHA is proposing this definition to align with the GHS Rev. 7
(UN GHS, 2017, Document ID 0060; UN GHS, 2016, Document ID 0131).
Because of this new paragraph, the subsequent numbering of existing
paragraphs in A.5.1 would be adjusted accordingly.
In A.5.4, Examples of scientifically validated test methods,
paragraph A.5.4.2, OSHA proposes to delete the Mouse spot test (OECD
484) as an example of an in vivo somatic cell mutagenicity test, as it
was deleted by the OECD on April 2, 2014. This change is consistent
with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2014,
Document 0087) and ensures that hazard classifications are being
conducted with the most current scientific principles.
Reproductive Toxicity--(Appendix A.7)
In appendix A.7, Reproductive toxicity, OSHA proposes to revise the
``effects on or via lactation'' hazard category classification criteria
to align with OSHA publication 3844 Hazard Classification Guidance for
Manufacturers, Importers and Employers (OSHA 3844, 2016, Document
0008). During the development of the guidance document, it became
apparent to OSHA that there were issues with regard to the
classification criteria in existing Figure A.7.1(b). The hazard
category for effects on or via lactation captures two separate effects:
i. Substances that can interfere with lactation; and
ii. substances and their metabolites that may be transmitted
through breast milk to children in amounts sufficient to cause concern
for the health of the breast feeding child.
However, the current criteria do not adequately distinguish between
these two separate effects. The first issue has both grammatical and
substantive aspects and is found in the second sentence of Figure
A.7.1(b), which currently reads:
``Chemicals that are absorbed by women and have been shown to
interfere with lactation or that may be present (including metabolites)
in breast milk in amounts sufficient to cause concern for the health of
a breastfed child, shall be classified to indicate this property
hazardous to breastfed babies.''
The italicized phrase is not grammatically correct and is also not
correct as a matter of substance because it ignores the effects on
lactation. As such, OSHA proposes to delete the text to indicate this
property ``hazardous to breastfed babies.'' In addition, the categories
of evidence currently listed in paragraphs (a) through (c) of Figure
A.7.1(b) all provide evidence for effects via lactation rather than
effects on lactation. To be more accurate, and to avoid confusion on
how to apply the criteria for effects on lactation, OSHA proposes to
modify the third sentence in the Figure to read: ``Classification for
effects via lactation shall be assigned on the basis of:'' These
proposed changes would not affect the classification of substances or
mixtures as reproductive toxicants; however, they would be more
accurate and provide more clarity for classifiers.
OSHA proposes to modify paragraph A.7.2.5.1 to include OECD Test
Guideline 443, Extended One Generation Reproductive Toxicity Study, as
an additional method for one or two generation toxicity testing.
Additionally, in Table A.7.1 ``Cut-off values/concentration limits of
ingredients of a mixture classified as reproductive toxicants or for
effects on or via lactation that trigger classification of the
mixture'', OSHA is proposing a correction to the top left heading from
``ingredients classified as'' to ``ingredient classified as.'' OSHA
believes that the use of the word ``ingredients'' in this context may
be confusing, as it may suggest that the additivity principle should be
applied. Therefore, OSHA is proposing this change for clarity. These
proposed modifications in appendix A.7 are consistent with the GHS Rev.
7 (UN GHS, 2017, Document ID 0060; UN GHS, 2014, Document ID 0221).
Specific Target Organ Toxicity-Single Exposure--(Appendix A.8)
In appendix A.8, OSHA proposes to make a correction to paragraph
A.8.1.6 to correctly name the hazard class as ``specific target organ
toxicity--single exposure'' instead of ``specific organ systemic
toxicity single exposure.'' Also, in paragraph A.8.2.1.7.3, OSHA
proposes to delete the erroneous inclusion of the second use of the
word ``evidence'' in the second sentence.
OSHA proposes to include the concept of ``relevant ingredient''
when classifying mixtures containing Category 3 ingredients using the
additivity approach. Under the HCS, as updated in
[[Page 9705]]
2012, the additivity principle was introduced in paragraph A.8.3.4.5.
However, a ``relevant ingredient'' for this procedure had not been
established. Proposed new paragraph A.8.3.4.6 would provide that in
cases where the additivity approach is used for Category 3 ingredients,
the ``relevant ingredients'' of a mixture are those which are present
in concentrations >=1% (w/w for solids, liquids, dusts, mists, and
vapors and v/v for gases), unless there is a reason to suspect that an
ingredient present at a concentration <1% is still relevant when
classifying the mixture for respiratory tract irritation or narcotic
effects. This proposed paragraph would align with the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2014, Document 0221).
Aspiration Hazard--(Appendix A.10)
The proposed changes to appendix A.10 would provide clarification
on the classification criteria for mixtures when data are available for
all ingredients or only for some ingredients. OSHA is proposing new
paragraph A.10.3.3.1 to clarify that the concept of ``relevant
ingredient'' applies and that relevant ingredients are those that are
present in concentrations of at least 1%. In addition, a new heading,
``Category 1,'' is proposed as new paragraph A.10.3.3.2. Proposed
A.10.3.3.2.1 and A.10.3.3.2.2 would clarify that the principle of
additivity applies in appendix A.10, but OSHA is not proposing any
substantive changes to the classification criteria. These proposed
changes would align with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060; UN GHS, 2014, Document 0221).
Changes to Definitions and Terminology, Clarification of Mandatory
Requirements, and Corrections
Definitions
OSHA proposes to update appendix A to include changes to the health
hazard definitions to reflect those adopted by the GHS Rev. 7 (UN GHS,
2017, Document ID 0060; UN GHS, 2016, Document ID 0131). Since OSHA
revised the HCS in 2012, the UNSCEGHS has revised all of the health
hazard definitions in the GHS. These modifications to the health hazard
definitions were incorporated as a result of the work of the UNSCEGHS
Practical Classification Issues working group. The scope of the working
group is to clarify the GHS classification criteria, as appropriate,
and to provide working examples to illustrate application of the
criteria. The previous health hazard definitions were not consistent
with respect to form or content, and many of the definitions were taken
directly from the OECD test guidelines.
The UNSCEGHS determined that the definitions should be more general
and neutral with respect to test guidelines and that test guideline
criteria should not be part of a definition. The group also determined
that the health hazard definitions should be clear and concise and that
there should be a clear differentiation between ``definitions'' and
``general considerations'' text. OSHA is proposing to adopt all of the
revised health hazard definitions from the GHS Rev. 7 in appendix A, as
well as corresponding changes to text throughout the appendix. For
example, in some cases OSHA is proposing to remove OECD test guidelines
from definitions and to move them to paragraphs outlining
classification criteria. The health hazard definitions that OSHA is
proposing in appendix A are:
Acute toxicity refers to serious adverse health effects
(i.e., lethality) occurring after a single or short-term oral, dermal,
or inhalation exposure to a substance or mixture.
Skin corrosion refers to the production of irreversible
damage to the skin; namely, visible necrosis through the epidermis and
into the dermis occurring after exposure to a substance or mixture.
Skin irritation refers to the production of reversible
damage to the skin occurring after exposure to a substance or mixture.
Serious eye damage refers to the production of tissue
damage in the eye, or serious physical decay of vision, which is not
fully reversible, occurring after exposure of the eye to a substance or
mixture.
Eye irritation refers to the production of changes in the
eye, which are fully reversible, occurring after exposure of the eye to
a substance or mixture.
Respiratory sensitization refers to hypersensitivity of
the airways occurring after inhalation of a substance or mixture.
Skin sensitization refers to an allergic response
occurring after skin contact with a substance or mixture.
Germ cell mutagenicity refers to heritable gene mutations,
including heritable structural and numerical chromosome aberrations in
germ cells occurring after exposure to a substance or mixture.
Carcinogenicity refers to the induction of cancer or an
increase in the incidence of cancer occurring after exposure to a
substance or mixture.
Reproductive toxicity refers to adverse effects on sexual
function and fertility in adult males and females, as well as
developmental toxicity in the offspring, occurring after exposure to a
substance or mixture.
Specific target organ toxicity-single exposure (STOT-SE)
refers to specific, non-lethal toxic effects on target organs occurring
after a single exposure to a substance or mixture.
Specific target organ toxicity-repeated exposure (STOT-RE)
refers to specific toxic effects on target organs occurring after
repeated exposure to a substance or mixture.
Aspiration hazard refers to severe acute effects such as
chemical pneumonia, pulmonary injury or death occurring after
aspiration of a substance or mixture.
Aspiration means the entry of a liquid or solid chemical
directly through the oral or nasal cavity, or indirectly from vomiting,
into the trachea and lower respiratory system.
Terminology Issues
The HCS is currently somewhat inconsistent in the way the terms
``hazard category'' and ``toxicity category'' are used throughout
appendix A. In some cases the terms are used interchangeably, while in
other instances the terms are intended to have different meanings. OSHA
has reviewed appendix A and is proposing revisions to ensure that these
terms are used appropriately and consistently. As such, OSHA proposes
to delete the term ``toxicity category'' and replace it with ``hazard
category'' in various places, including paragraphs A.0.5, A.1, A.8,
A.9, and A.10. These proposed changes would align with the GHS Rev. 7
(UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document 0084).
Mandatory Language
OSHA is proposing to update a number of provisions in appendix A to
make it clear that those provisions are mandatory. For example, OSHA
proposes to change the term ``should'' to ``must'' in paragraph
A.3.4.3.3. The change would clarify that the cut-off value/
concentrations in Table A.3.3 are mandatory when determining if a
mixture must be classified as seriously damaging to the eye or an eye
irritant.
Corrections
OSHA proposes to correct a few errors that currently exist in the
HCS. OSHA erroneously did not include appendix A.4, respiratory or skin
sensitization, in the list of health hazards referenced in the
``concentration of mixtures'' paragraph at A.0.5.1.3. OSHA proposes
[[Page 9706]]
to add a reference to appendix A.4 in paragraph A.0.5.1.3 to clarify
that the concentration of mixtures bridging principle applies to
respiratory and skin sensitization. Similarly, appendix A.4 was also
erroneously excluded from the list of health hazards referenced in the
``interpolation within one toxicity category'' paragraph at A.0.5.1.4.
Thus, OSHA also proposes to add a reference to appendix A.4 in
paragraph A.0.5.1.4 to clarify that the interpolation bridging
principle applies to respiratory and skin sensitization. In addition,
OSHA proposes to correct the cross-reference from A.1.3.6.2.3 to
A.1.3.6.2.4 in Figure A.1.1 and paragraph A.1.3.6.2.2.
D. Appendix B
OSHA is proposing a number of changes to appendix B. First, since
the HCS was aligned with the GHS in 2012, new physical hazard classes
or hazard categories have been added to the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060). OSHA proposes to adopt those additions. Second, the
GHS Rev. 7 (UN GHS, 2017, Document ID 0060) contains several updates to
consensus standards and testing methods. Although the HCS does not
require testing and permits classifiers to use data from literature or
experience for classification purposes, OSHA is proposing to update
consensus standards and testing methods referenced in appendix B in
accordance with the GHS Rev. 7 to ensure that data considered for
classification incorporate updated scientific principles. Third, OSHA
is proposing certain corrections and clarifications to appendix B to
address (1) previous inadvertent omissions from the GHS or the HCS; (2)
changes made to the GHS to improve clarity or technical accuracy; and
(3) how some hazard classes should be evaluated in light of the
addition of new hazard classes in the GHS. These proposed changes are
discussed below and would align the HCS with the GHS while improving
the classification and communication of hazards \59\ and maintaining or
enhancing worker safety and health. Additionally, as noted elsewhere,
aligning the HCS with the GHS would ease compliance burdens for U.S.
stakeholders that must also comply with international requirements for
hazard classification and communication.
---------------------------------------------------------------------------
\59\ Specific changes to the hazard and precautionary statements
are discussed below in the section on appendix C.
---------------------------------------------------------------------------
OSHA is also proposing to make a limited number of changes to
appendix B that arise out of its implementation of the HCS, as updated
in 2012. These changes, explained below, would clarify compliance
requirements. OSHA believes that all of these proposed changes maintain
existing safety and health protections while easing or having no effect
on the compliance burdens for regulated entities.
Finally, OSHA explains below that it is not proposing to
incorporate one update reflected in the GHS Rev. 7 because that
particular update is inconsistent with the scope of the HCS.
OSHA is providing a redline strike out version of appendix B, which
reflects all of OSHA's proposed revisions, in the docket and on the
OSHA website (OSHA, 2020, Document ID 0222; https://www.osha.gov/dsg/hazcom). This will allow interested parties to view all of the proposed
changes in context. OSHA strongly encourages stakeholders to review
that document in conjunction with the discussion of the proposed
revisions below, as the discussion below does not fully describe all of
the non-substantive or editorial changes OSHA is proposing.
Explosives--(Appendix B.1)
OSHA is proposing a few minor amendments to appendix B.1,
Explosives. The first change that OSHA is proposing involves a
clarification to the classification criteria for Division 1.6
explosives in B.1.2(f). Under the GHS Rev. 3, one of the criteria for
classification of an article [OSHA uses the term ``item'' in the HCS]
as a Division 1.6 explosive is that it contains ``only'' extremely
insensitive detonating chemicals (UN GHS, 2009, Document ID 0085). The
GHS Rev. 7 (UN GHS, 2017, Document ID 0060) states that the criteria is
met if the article [``item'' in the HCS] ``predominantly'' contains
extremely insensitive detonating chemicals. OSHA is proposing to make
the same change to paragraph B.1.2(f) of appendix B in the HCS.
Changing the criteria from containing ``only'' extremely insensitive
detonating chemicals to ``predominantly'' containing extremely
insensitive detonating chemicals is more technically accurate and
better aligns with the guidance in test series 7 in the UN Manual of
Tests and Criteria (UN TDG, 2016, Document ID 0151). OSHA believes that
consistency in the use of terms will reduce confusion for chemical
manufacturers or importers when classifying explosives.
OSHA is also proposing to add two notes from the GHS (UN GHS, 2017,
Document ID 0060) to appendix B, paragraph B.1.3.1, that are related to
the addition of the desensitized explosives hazards class (proposed
appendix B.17), which is discussed later in this document. The first
new note OSHA is proposing to add (Note 2) would provide that
explosives for which explosive properties have been suppressed or
reduced must be classified as desensitized explosives. The second new
note OSHA proposes (Note 3) would provide that some chemicals that are
exempt from classification as explosives under UN Recommendations on
the Transport of Dangerous Goods guidelines still have explosive
properties, which must be communicated in section 2 (Hazard
identification) and section 9 (Physical and chemical properties) of the
SDS, as appropriate. The notes would be incorporated in the HCS with
edits to change these provisions from recommendations in the GHS to
requirements in the HCS (e.g., ``may be a candidate for classification
as'' in the GHS would be revised to ``shall be classified as'' in the
HCS) and to revise the GHS terminology to terminology more appropriate
for the HCS (e.g., ``substances and mixtures'' in the GHS would be
revised to. ``chemicals'' in the HCS).
Flammable Gases--(Appendix B.2.)
OSHA is proposing several changes to the Flammable Gases hazard
class (appendix B.2). Most significantly, OSHA is proposing to
subdivide Category 1 of this class into two subcategories, 1A and 1B,
and to specify that pyrophoric gases and chemically unstable gases are
to be classified as Category 1A. These proposed changes would provide
more detailed information about the flammable gas hazards and track
changes made in the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) since
OSHA updated the HCS in 2012. These proposed changes would allow
downstream users to have a better understanding of the severity of the
hazards associated with flammable gases. Downstream users could then
use this information to take appropriate precautions or determine if a
substitute chemical is less hazardous.
The HCS currently lists two categories for flammable gases--
Category 1 (Extremely flammable) and Category 2 (flammable)--that are
based on the percentage of the gas in a mixture with air that is
ignitable and on ranges of flammability in air. In practice, with the
current criteria, almost all flammable gases (except ammonia and methyl
bromide, which are treated separately) are classified as Category 1.
This means that, for hazard identification and communication purposes,
no distinctions are being drawn between gases that exhibit a wide
spectrum of flammable properties. OSHA has preliminarily concluded that
Category 1
[[Page 9707]]
is too broad and can lead downstream users to choose a chemical without
realizing that an alternative choice is actually less flammable. For
example, 2,3,3,3-Tetrafluoropropene is a non-ozone depleting
refrigerant which ignites less rapidly or violently than some other
flammable gases. Many of these types of gases were developed as a
result of the Montreal and Kyoto protocols, international treaties
intended to phase out gases that are ozone depleting (UN GHS, 2016,
Document ID 0138). However, with the current classification system,
propane, which has a rapid, explosive ignition with a burn velocity of
46 cm/s, and 2,3,3,3-Tetrafluoropropene (R-1234yf), which has a slow,
weak ignition, with a burn velocity of 1.5 cm/s, would both be
classified as Category 1 gases, thus making it appear that the two
gases are equally flammable when in fact 2,3,3,3-Tetrafluoropropene is
considerably less flammable (UN GHS, 2016, Document ID 0138).
OSHA and DOT actively participated in the UN negotiations (joint
informal working group) in 2015 to ensure that flammable gases are
properly evaluated, classified and communicated. The joint informal
working group activities included identifying, gathering, and reviewing
data on ``less flammable'' gases, including the conduct of numerous
burning velocity tests using approved test methods, as well as tests to
demonstrate ignition behavior, flame propagation, and the speed of the
flame front (UN GHS, 2016, Document ID 0254).
The revised classification criteria in Table 2.2.1 in Chapter 2.2
of the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) reflect
recommendations made by the joint informal working group. The joint
informal working group agreed that all flammable gases currently
classified as Category 1 flammable gases should remain so. This
decision allows the transport classification and communication scheme
to remain the same. However, the joint informal working group agreed
that Category 1 should be separated into two sub-categories, Category
1A and Category 1B, when data is available on burning velocity and
lower flammability limit. This separation allows for more precise
classification of chemicals and more appropriate communication of the
hazards associated with flammable gases.
This proposed approach for classifying flammable gases is also
consistent with the approach described in ANSI/ASHRAE Standard 34-
2013--Designation and Safety Classification of Refrigerants (ANSI/
ASHRAE, 2013, Document ID 0160). The ANSI/ASHRAE standard allows
refrigerant gases (which can be category 1A or 1B) to be classified
based on both the lower flammability limit and burning velocity (see
Figure 6.1.4 and Section 6.1.3.2.1 (ANSI/ASHRAE, 2013, Document ID
0160). OSHA's proposed cut-off for the burning velocity for category 1A
and 1B chemicals is the same as that in the ASHRAE standard. Therefore,
the proposed approach is consistent with accepted scientific principles
and industry norms.
OSHA has preliminary concluded that the classification scheme in
Table 2.2.1 of the GHS Rev. 7 (UN GHS, 2017, Document ID 0060)
maintains safety for workers while allowing for more precise hazard
classification and communication. Therefore, OSHA is proposing to
replace Table B.2.1 of the HCS with the criteria from Table 2.2.1 in
the GHS Rev. 7 (UN GHS, 2017, Document ID 0060). The only modification
that OSHA proposes making to the GHS Table 2.2.1 is to add units of
measurement used in the United States (e.g., degrees Fahrenheit). Under
the proposed new table, all flammable gases that are currently
classified as Category 1 flammable gases would be classified as
Category 1A, unless data on flammability limit or fundamental burning
velocity indicates that the gas should be classified as Category 1B.
For a gas to be classified in Category 1B, data would have to show that
its lower flammability limit is more than 6% by volume in air or its
fundamental burning velocity is less than 10 cm/s; in addition, the gas
could not be either pyrophoric or chemically unstable. Since the HCS
does not require testing, the data required to classify a gas as a
Category 1B flammable gas could be obtained from literature. However,
if data is lacking in the literature, then testing would be necessary
to establish that a newly-developed flammable gas qualifies for
classification as a Category 1B flammable gas. The joint informal
working group compiled a list of data available on burning velocity and
flammability limits for pure flammable gases (OSHA, 2017, Document ID
0164).
When OSHA revised the HCS in 2012, pyrophoric gases were not
classified under the GHS, Rev. 3 (UN GHS, 2009, Document ID 0085).
Therefore, to ensure that the hazards of pyrophoric gases would
continue to be covered and communicated, OSHA maintained the approach
taken in the HCS starting in 1994. This involved addressing pyrophoric
gases under the definition of ``hazardous chemical'' and maintaining a
definition for ``pyrophoric gas'' in paragraph (c) of the HCS (77 FR
17704). While OSHA retained the definition for ``pyrophoric gas'' when
it updated the HCS in 2012, the agency explained it also intended to
continue to work with the UNSCEGHS to add the pyrophoric gas hazard to
the GHS, along with two other hazards that OSHA covered under the HCS
but that were not classified under the GHS: Simple asphyxiants and
combustible dust (77 FR 17704). Since OSHA revised the HCS in 2012, the
UNSCEGHS updated the criteria for flammable gases to include pyrophoric
gases (UN GHS, 2014, Document ID 0086; UN GHS, 2017, Document ID 0060).
The UNSCEGHS agreed that pyrophoric gases, as well as chemically
unstable gases, should always be classified as Category 1A flammable
gases because of the nature of these two types of gases; pyrophoric
gases ignite spontaneously in air at temperatures of 54 [deg]C (130
[deg]F) or below, and chemically unstable gases are able to react
explosively even in the absence of air or oxygen. Under the GHS Rev. 7
(UN GHS, 2017, Document ID 0060), pyrophoric gases and chemically
unstable gases are both classified as Category 1A. OSHA preliminarily
agrees with this decision and proposes incorporating it into appendix
B.2.
If, as proposed, OSHA adds pyrophoric gases as a sub-category of
flammable gases in appendix B.2, and, as proposed, includes a
definition of pyrophoric gas in appendix B.2., it would no longer be
necessary to include these gases as part of the definition of
``hazardous chemical'' or to include a definition for ``pyrophoric
gas'' in Sec. 1910.1200(c). Therefore, OSHA proposes to delete those
terms in Sec. 1910.1200(c). OSHA also proposes to incorporate the
definition of ``pyrophoric gas'' found in the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060), in paragraph B.2.1. OSHA currently defines
pyrophoric gas as a chemical in the gaseous state that ``will ignite''
spontaneously in air at a temperature of 130 [deg]F (54.4 [deg]C) or
below. The GHS Rev. 7 defines a pyrophoric gas as a flammable gas that
is ``liable to ignite'' spontaneously in air at a temperature of 54
[deg]C (130 [deg]F) or below (UN GHS, 2017, Document ID 0060). The
change in the definition from a gas that ``will ignite'' to a gas that
is ``liable to ignite'' was made because some pyrophoric gases may have
a delayed ignition time (UN GHS, 2013, Document ID 0086). OSHA
preliminarily finds the term ``liable to ignite'' to be more accurate,
from a technical perspective. OSHA does not believe that these changes
would have a significant impact on the scope of
[[Page 9708]]
gases considered pyrophoric gases, nor does OSHA expect that chemical
manufacturers or importers would need to reclassify chemicals due to
these changes.
As noted above, OSHA proposes adding a new sub-category for
chemically unstable gases to the flammable gases hazard class to allow
for more accurate communication of the hazards associated with those
gases. OSHA proposes to adopt the GHS Rev. 7 definition of a chemically
unstable gas, i.e., a flammable gas that is able to react explosively
even in the absence of air or oxygen (UN GHS, 2017, Document ID 0060),
in paragraph B.2.1. Consistent with the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060), under proposed Table B.2.1, a Category 1A chemically
unstable gas would be further sub-characterized into one of two
categories based on the temperature and pressure at which it becomes
unstable. The proposed criteria for Category 1A/A chemically unstable
gases are flammable gases which are chemically unstable at 20 [deg]C
(680 [deg]F) and a standard pressure of 101.3 kPa (14.7 psi). The
proposed criteria for Category 1A/B chemically unstable gases are
flammable gases which are chemically unstable at a temperature greater
than 20 [deg]C (680 [deg]F) and/or a pressure greater than 101.3 kPa
(14.7 psi).
As chemically unstable gas is a subcategory of flammable gases, any
chemical that meets the criteria for chemically unstable gas meets the
current definition of flammable gas. While these hazards are currently
classified in flammable gases under the HCS the UNSCEGHS noted that
these gases exhibit slightly different behaviors and have the
propensity to react dangerously even in the absence of any reaction
partner (e.g., air or oxygen) and should have different hazard
communication elements (UN GHS, 2010, Document ID 0210). Types of
flammable gases or gas mixtures that might be candidates for
classification as chemically unstable are flammable gases with
functional groups such as triple-bonds, adjacent or conjugated double-
bonds, halogenated double-bonds, and strained rings (UN GHS, 2010,
Document ID 0210). Because chemical manufacturers are currently
classifying chemically unstable gases as flammable gases, OSHA does not
consider these gases to be a new hazard. Instead, OSHA believes the
addition of chemically unstable gases as a separate category in the
appendix for flammable gases (appendix B.2) would improve the way the
hazards of these gases are identified, evaluated, and communicated.
The GHS Rev. 7 (UN GHS, 2017, Document ID 0060) added three
clarifying notes under Table 2.2.1 that were not included in the GHS
Rev. 3 (UN GHS, 2009, Document ID 0085). The notes provide guidance on
the classification of flammable gases under the new hazard categories.
OSHA is proposing to add these notes to the HCS following Table B.2.1
(as new Note 2, Note 3, and Note 4) because they allow for better
hazard classification.
The GHS Rev. 7, in Chapter 2.2.4.2, provides additional guidance on
the classification of flammable gases, including the new hazard
categories of pyrophoric gases, chemically unstable gases, and 1B
flammable gases (UN GHS, 2017, Document ID 0060). It includes updated
references to consensus standards and test methods (i.e., ISO
10156:2010), and new references to consensus standards and test methods
related to the new hazard categories (i.e., ISO 817:2014, IEC 60079-20-
1 ed1.0 (2010-01), or DIN 51794, and Part III of UN of the Manual of
Tests and Criteria). OSHA proposes to adopt these changes in the HCS
appendix B.2.3, with edits to make the GHS criteria mandatory (i.e.,
changing ``should'' to ``shall''), to add U.S. units of measurement
(e.g., Fahrenheit), and to add statements that cited standards and test
methods are incorporated by reference under 29 CFR 1910.6. This
proposed modification would also align with the GHS Rev. 7 (UN GHS,
2017, Document ID 0060). However, OSHA does not intend to require those
already classified using an earlier version of ISO 10156, only those
classifying new chemicals or chemicals not already classified. To
incorporate this guidance from the GHS Chapter 2.2.4.2, OSHA is
proposing edits to existing paragraph B.2.3. (B.2.3.1, as proposed) and
new paragraphs B.2.3.2, B.2.3.3, and B.2.3.4.
Aerosols--(Appendix B.3)
OSHA is proposing to follow the GHS Rev. 7 (UN GHS, 2017, Document
ID 0060) by expanding the existing Flammable Aerosols hazard class
(appendix B.3) to include non-flammable aerosols as well as flammable
ones. Under the GHS Rev. 3 and the current HCS, Chapter 2.3 and
appendix B.3, respectively, were titled ``Flammable Aerosols.'' Under
the GHS Rev. 3, the hazards presented by non-flammable aerosols were
either not classified at all or, more likely, were classified in
another health hazard class or physical hazard class (e.g., gases under
pressure) (UN GHS, 2009, Document ID 0085). Flammable aerosols were
likely to be classified as both flammable aerosols and gases under
pressure.
OSHA believes that most aerosols are classified as gases under
pressure under the GHS Rev. 3 (and accordingly under the existing HCS)
because of the design criteria of the aerosols (ERG, 2015, Document ID
0163) under DOT regulations. Under DOT regulations, aerosols are non-
refillable receptacles containing a gas compressed, liquefied, or
dissolved under pressure, and the highest permissible pressure is 180
psig at 130 [deg]F (see 49 CFR 171.8, 173.306). Accordingly, under DOT
regulations, most aerosols meet the current HCS criteria for gases
under pressure, which are gases contained in a receptacle at a pressure
of 200 kPa (29 psi) or more, or which are liquefied or liquefied and
refrigerated (see existing paragraph B.5.1 in appendix B.5). However,
OSHA believes that classifying aerosols as gases under pressure may not
accurately identify the hazards of aerosols because aerosol containers
differ from pressurized gas cylinders in terms of container
characteristics and failure mechanisms, as described further below.
Since the GHS Rev. 3 (UN GHS, 2009, Document ID 0085), the UNSCEGHS
and the UN Sub-committee of Experts on the Transport of Dangerous Goods
(UNSCETDG) agreed to rename Chapter 2.3 ``Aerosols'' and to add a new
non-flammable aerosol hazard category, Category 3, to the aerosols
hazard class (UN GHS, 2018, Document ID 0249). This hazard category
captures aerosols that (1) contain 1% or less flammable components (by
mass); and (2) have a heat of combustion that is less than 20 kJ/g.
Before proposing to adopt this category for non-flammable aerosols,
OSHA reviewed the impact of this change to ensure that it would not
compromise worker safety and health. OSHA assessed the hazards
associated with aerosol containers and compressed gas cylinders. An ERG
study evaluated how aerosol products and gases under pressure differ in
terms of container characteristics, failure mechanisms, and previous
incidents (ERG, 2015, Document ID 0009).
The ERG report concluded that sizes and pressures of compressed gas
cylinders far exceed those of hand-held containers typically used for
aerosol products (ERG, 2015, Document ID 0009). The report also noted
differences in failure mechanisms for pressurized cylinders versus
aerosols (ERG, 2015, Document ID 0009). As an example, increased
temperatures can result in the release of container contents from the
activation of pressure relief devices on
[[Page 9709]]
cylinders, whereas increased temperatures can result in the bursting of
aerosol cans, which do not contain pressure relief devices. Also,
hazards from falling cylinders include the release of contents
following the valve breaking, the cylinder becoming a projectile or
pinwheel, or the crushing of employees in the area; although aerosol
containers can be damaged if they are dropped or punctured, they do not
pose the same hazards as falling cylinders.
ERG reported that occupational incidents involving cylinders
included explosions during high temperature activities (such as
welding) and explosions resulting from mechanical deformation (e.g.,
from falling cylinders), over-pressurization of cylinders (e.g., from
overfilling, which can result in a rupture of the cylinder), or leaks
due to corrosion (ERG, 2015, Document ID 0009). Most incidents with
aerosol cans involved explosions following heating or puncture of the
can (ERG, 2015, Document ID 0009). The ERG report concluded that
although non-flammable aerosol cans do not present a significant fire
hazard, they can present a hazard from bursting resulting from thermal
content expansion during heating. (ERG, 2015, Document ID 0009).
In addition to the ERG report, OSHA also considered data from the
agency's Fatality and Catastrophe Information Summary (FatCat)
database, located at https://www.osha.gov/pls/imis/accidentsearch.html
(Document ID 0204), to evaluate the nature and severity of injuries and
fatalities resulting from the use of aerosols and compressed gases. To
determine if an incident was related to aerosols or compressed gas
cylinders, OSHA searched for the keywords ``aerosol,'' ``spray,'' or
``foam'' (to identify aerosols), and the keywords ``compressed,''
``cylinder,'' or ``CNG'' (to identify compressed gases). The data
reviewed is available in the docket (OSHA, 2019, Document ID 0204).
From 1995 to 2014 there were more incidents related to the use of
compressed gas cylinders than to the use of aerosol containers, but the
percentage of the incidents that resulted in fatalities was similar
(29% versus 28%, respectively). However, as explained below, fatalities
are more likely to be associated with the container itself when
compressed gas receptacles are in use as compared to situations
involving aerosol containers. (OSHA, 2019, Document 0204).
Fatalities associated with use of compressed gas cylinders and
aerosol containers primarily fall into three categories: (1) Incidents
due to the contents of the container, such as flash fires or
explosions; (2) incidents due to the container itself, such as
incidents related to pressure, container failure, or ruptures; and (3)
incidents unrelated to the use of the container, such as heart attacks
or falls. A higher percentage of fatalities fell into the second
category (incidents related to the container itself) for compressed gas
cylinders (64% of the compressed gas cylinder fatalities) than for
aerosol containers (17% of the aerosol fatalities). Conversely, a
greater proportion of fatalities related to aerosols were attributed to
reasons other than the container itself (83% for aerosol containers
versus 36% for cylinders) (OSHA, 2019, Document ID 0204). This included
fatalities related to the contents of the container and those in the
third, ``miscellaneous,'' category (where the fatality could not be
directly related to the use of the container, e.g., situations such as
heart attacks, falls, lack of training that occurred while employees
were working with, or that generally related to, the use of aerosol or
compressed gas cylinders) (OSHA, 2019, Document 0204). Thus, it appears
that employees are at greater risk of a fatality due to the failure of
the container if they are working with compressed gas cylinders than
they are if they are working with aerosol cans.
Following a review of the data and the ERG report, OSHA
preliminarily concludes that a new category for non-flammable aerosols
is appropriate. OSHA believes this category would allow the hazards of
non-flammable aerosols to be more appropriately classified and
communicated, resulting in improved worker protection. The new hazard
category would provide downstream users with more appropriate
communication on the label by adding precautionary statements: Keep
away from heat, hot surfaces, sparks, open flames and other ignition
sources; No smoking; and Do not pierce or burn, even after use (see
appendix C). Additionally, this new classification would ensure
compressed gas pictograms are not included on aerosol labels,
eliminating the risk of ``over warning'' about the hazards of aerosol
containers (UN, 2010, Document ID 0095).
Specific changes OSHA is proposing include: Updating the aerosol
hazard class to include non-flammable aerosols (hazard Category 3 in
Table B.3.1), changing the name of appendix B.3 from ``Flammable
Aerosols'' to ``Aerosols,'' replacing the phrase ``flammable aerosols''
with ``aerosols'' throughout appendix B.3, as appropriate, and adding
clarifying information from the GHS Rev. 7 to paragraph B.3.2 (UN GHS,
2017, Document ID 0060). For example, OSHA is proposing to revise Note
2 to B.3.2.1 to explain that aerosols do not fall within the scope of
gases under pressure, but may fall within the scope of other hazard
classes. OSHA's preliminarily conclusion that aerosols (flammable and
non-flammable) should not also be classified as gases under pressure
would ensure that the appropriate hazard warnings are presented on
aerosol containers.
OSHA is proposing to adopt the GHS Rev. 7 (UN GHS, 2017, Document
ID 0060) criteria for a non-flammable aerosol (i.e., an aerosol that
does not meet the criteria for Category 1 or 2, contains less than or
equal to 1 percent flammable components (by mass), and has a heat of
combustion less than 20 kJ/g), and to add those criteria as new
Category 3 in Table B.3.1. This new category, Category 3, would update
hazard communication requirements to better reflect the true hazards of
non-flammable aerosols. This would result in changing the labeling for
any such aerosols that are currently classified as compressed gases. In
these situations, the ``gas cylinder'' pictogram would become
unnecessary, as this hazard class would no longer be considered a
compressed gas, the signal word ``danger'' would change to ``warning,''
due to the decreased hazard, and a hazard statement of ``contains gas
under pressure; may explode if heated'' would change to ``pressurized
container, may burst if heated'', which would more accurately reflect
the hazards associated with this category (see proposed appendix
C.4.16). As discussed above, OSHA believes that this approach would
better differentiate between the hazards associated with compressed
gases and the hazards associated with aerosols.
Oxidizing Gases--(Appendix B.4)
OSHA proposes to revise the note in B.4.1, and the text in the
``Additional classification considerations'' paragraph at B.4.3, to
clarify that the provisions are referring to the most recent version of
the ISO 10156 standard, (ISO, 10156, 2010). This proposed change would
provide more clarity on the definition and classification of oxidizing
gases and lead to more accurate classification and improved
communication. This proposed modification would also align with the GHS
Rev. 7 (UN GHS, 2017, Document ID 0060). However, OSHA does not intend
to require those already classified using an earlier version of ISO
10156, only those classifying new chemicals or chemicals not already
classified.
[[Page 9710]]
Gases Under Pressure--(Appendix B.5)
OSHA is proposing to change the definition of gases under pressure
in B.5.1 to align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060).
OSHA proposes to add a temperature of 20 degrees Celsius (68 degrees
Fahrenheit) to the definition so that the full definition would define
gases under pressure as gases which are contained in a receptacle at a
pressure of 200 kPa (29 psi) (gauge) or more at 20 [deg]C (680 [deg]F),
or which are liquefied or liquefied and refrigerated. The change is
intended to clarify that the pressure of the receptacle is measured at
standard conditions. OSHA is also proposing to add a note to Table
B.5.1 to clarify that aerosols should not be classified as gases under
pressure. This proposed change is a consequence of OSHA's proposal to
add a new hazard category for non-flammable aerosols, as discussed
previously.
Flammable Liquids--(Appendix B.6)
OSHA is proposing to make three clarifying changes to the flammable
liquid hazard class in appendix B.6. First, OSHA is proposing to add a
reference to the Flammable Liquids standard, specifically 29 CFR
1910.106(a)(14), in paragraph B.6.3 in order to provide additional
guidance about methods that can be used to determine flashpoint.
Second, after updating the HCS in 2012, OSHA realized there may be
a concern with ensuring that information needed to determine the
appropriate storage for flammable liquids is adequately documented on
the SDS. Per 29 CFR 1910.106(a)(5), when an accurate boiling point is
unavailable, or for mixtures which do not have a constant boiling
point, the boiling point may be based on the 10% point of a
distillation performed in accordance with the Standard Method of Test
for Distillation of Petroleum Products, ASTM D-86-62. Together with an
appropriately measured flash point, this boiling point can be used to
categorize the mixture for use with Table H-12 in Sec. 1910.106 to
determine the maximum allowable container size and type. Use of a
boiling point reported in section 9 of an SDS (physical properties),
which is based on the ``first drop'' (or initial) distillation
temperature in D-86, will likely be conservative, but may lead to more
restrictive storage requirements than would be the case using the 10%
distillation point (see appendix D, section 9(f)). OSHA is proposing to
add a clarifying footnote to B.6.3 explaining that to determine the
appropriate container size and container type for a flammable liquid,
the boiling point must be determined by the methods specified under
OSHA's Flammable Liquids standard (29 CFR 1910.106(a)(5)) and listed on
the SDS. In addition, the proposed note would explain that the chemical
manufacturer, importer, or distributor must clearly note on the SDS (in
sections 7 and 9) if a calculation other than initial boiling point was
used for storage purposes. OSHA did not intend for the updated HCS
classification requirements for flammable liquids to impact the
longstanding storage requirements under 29 CFR 1910.106 and views this
proposed note as a method to ensure that the proper container size and
type will be used for storing flammable liquids and that all necessary
information is appropriately communicated on the SDS. OSHA is not
proposing any changes to the classification criteria for flammable
liquids under the HCS. OSHA is requesting comments on whether a
footnote like the one proposed for B.6.3 should also be inserted in
appendix D, section 9.
Finally, OSHA realized that a note regarding cross-classification
of aerosols was inadvertently omitted from appendix B.6 (flammable
liquids). In appendix B.3 (flammable aerosols), note 2 to the
classification criteria currently indicates that ``[f]lammable aerosols
do not fall additionally within the scope of flammable gases, flammable
liquids, or flammable solids.'' The HCS currently contains a cross-
referencing note in appendix B.2 (flammable gases), but OSHA
inadvertently omitted the statement in appendix B.6 (flammable
liquids). OSHA is therefore proposing to add a note stating that
aerosols should not be classified as flammable liquids in appendix B.6,
following Table B.6.1, for consistency and to minimize confusion. This
would align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060).
Flammable Solids--(Appendix B.7)
The only change proposed to appendix B. 7 (flammable solids) is a
new note (Note 2) following Table B.7.1 stating that aerosols should
not be classified as flammable solids. As with flammable liquids, the
UNSCEGHS observed this omission in the flammable solids chapter, and
the GHS Rev. 7 includes this note (UN GHS, 2017, Document ID 0060).
Self-Heating Chemicals--(Appendix B.11)
OSHA proposes adding a note to Table B.11.1. This proposed note
would explain that classification of solid chemicals shall be based on
tests performed on the chemical as presented. For example, if the
chemical is presented for supply or transport in a physical form
different from that which was tested and which is considered likely to
materially alter its performance in a classification test,
classification must be based on testing of the chemical in the new
form. Although this note was included in the GHS Rev. 3 (UN GHS, 2009,
Document ID 0085), and incorporated into appendices B.1, B.7, B.10,
B.12 and B.14 in the HCS in 2012, it was inadvertently omitted from
appendix B.11. OSHA is proposing to add the note to be consistent with
the GHS and the way the HCS treats other physical hazards.
Chemicals Which, in Contact With Water, Emit Flammable Gases--(Appendix
B.12)
OSHA proposes to update the classification criteria for Category 3
of this hazard class in Table B.12.1. In the GHS Rev. 3 (UN GHS, 2009,
Document ID 0085) and the existing HCS, one of the criteria for a
Category 3 classification is that the maximum rate of evolution of the
flammable gas is ``equal to or greater than 1 liter per kilogram of
chemical per hour.'' However, this criteria does not accurately reflect
the corresponding criteria in Test N.5 (test method for substances
which, in contact with water, emit flammable gases) in Part III, sub-
section 33.4.1.4.4.4 of the UN Manual of Tests and Criteria (UN TDG,
2016, Document ID 0151), which provides that the maximum rate of
evolution of the flammable gas is greater than 1 liter per kilogram of
chemical per hour. OSHA proposes to delete the words ``equal to or'' in
the Category 3 criteria in Table B.12.1 to make the classification
criteria consistent with the criteria in the test method. This will
align the HCS with the GHS Rev.7 (UN GHS, 2017, Document ID 0060) and
would not affect worker protections.
Oxidizing Solids--(Appendix B.14)
OSHA is proposing to add a second set of classification criteria to
B.14.2 and to Table B.14.1.based on a new UN test method. Under the GHS
Rev. 3 (UN GHS, 2009, Document, ID 0085), classification of oxidizing
solids was based only on Test O.1 from Part III, sub-section 34.4.1 of
the UN Manual of Tests and Criteria (UN TDG, 2016, Document ID 0151).
This is reflected in the current HCS, appendix B.14. However, the test
material used as the reference mixture in Test O.1 has been noted to
pose a cancer hazard and is difficult to purchase. Therefore, a new
test, Test O.3, Gravimetric tests for
[[Page 9711]]
oxidizing solids, has been added to Part III, sub-section 34.4.3 of the
UN Manual of Tests and Criteria (UN TDG MTC, 2016, Document ID 0151).
This new test underwent a thorough evaluation, including round robin
testing, led by the UNSCETDG (UN SCETDG, 2016, Document ID 0150). Test
O.3 uses a reference mixture of calcium peroxide and cellulose, whereas
Test O.1 uses the reference substances potassium bromate and cellulose
(UN TDG, 2016, Document ID 0165).
Consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060),
OSHA proposes to allow oxidizing solids to be classified using either
Test O.1 or Test O.3. Since the proposed classification criteria would
allow the use of data from either Test O.1 or O.3, data from existing
classifications could be used and no new testing would be required for
substances or mixtures that were previously classified based on Test
O.1.
OSHA also proposes to update Note 1 to Table B.14.1 to reflect a
2017 revision to the International Maritime Solid Bulk Cargoes Code for
testing of explosion hazards (IMSBC, 2017, Document ID 0141).
Corrosive to Metals--(Appendix B.16)
OSHA is not proposing to make any changes to appendix B.16,
Corrosive to Metals. This is notable because OSHA has preliminarily
decided not to adopt a note that was added in the GHS Rev. 7. Table
2.16.2 in Chapter 2.16 of the GHS Rev. 7 (UN GHS, 2017, Document ID
0060) contains a note stating: ``Where a substance or mixture is
classified as corrosive to metals but not corrosive to skin and/or
eyes, some competent authorities may allow the labelling provisions
described in 1.4.10.5.5.'' Chapter 1.4.10.5.5 contains labeling
provisions that apply to ``substances or mixtures which are in the
finished state as packaged for consumer use.'' OSHA has preliminarily
concluded that the note in question, and the labeling provisions it
refers to, are not applicable to the HCS because the HCS applies only
to use of chemicals in the workplace, and not to consumer products (see
29 CFR 1910.1200(b)(5)(v)). Therefore, OSHA is not proposing to adopt
the note found in Table 2.16.2 of Chapter 2.16 of the GHS Rev. 7.
Desensitized Explosives--(Appendix B.17)
OSHA is proposing to follow the GHS Rev. 7 (UN GHS, 2017, Document
ID 0060) by adding a new physical hazard class for desensitized
explosives. Desensitized explosives are chemicals that are treated in
such a way to stabilize the chemical or reduce or suppress its
explosive properties. These types of chemicals can pose a hazard in the
workplace when the stabilizer is removed, either as part of the normal
work process or during storage of the chemical. Therefore, it is
important that the hazards be identified and appropriately
communicated.
In the HCS, as revised in 2012, OSHA acknowledged, consistent with
the GHS Rev. 3 (UN GHS, 2009, Document ID 0085), that these chemicals
are considered explosives if the wetting agent is removed, by including
the precautionary statement ``keep wetted with'' and instructing the
chemical manufacturer, importer, or distributor to specify appropriate
material for wetting if drying out increases the explosion hazard (see
existing appendix C at C.4.14). However, the hazard statement, signal
word, pictogram and other precautionary statements required under
existing C.4.14 are geared to more conventional explosives. This gap in
communication was recognized as early as 2005, when the UNSCEGHS noted
that desensitized explosives may become explosive under certain
circumstances--especially after long term storage and during handling
and use (UN GHS, 2005, Document ID 0206). The UNSCEGHS examined the
issue of hazard classification for desensitized explosives and
concluded a new hazard class was warranted to ensure the appropriate
hazard statement, signal word and precautionary statements for
desensitized explosives were incorporated into the GHS (UN GHS, Report,
2014, Document ID 0087). The GHS Rev. 7 (UN GHS, 2017, Document ID
0060; UN GHS, 2016, Document ID 0142) separately classified
desensitized explosives with a full set of unique label elements
(including the appropriate signal word, hazard statement, pictogram,
and precautionary statements). As separately classified, desensitized
explosives are labeled with a flame pictogram rather than the explosive
bomb used for explosives, and the precautionary statements are tailored
to the specific traits of desensitized explosives (e.g., Avoid heating
under confinement or reduction of the desensitizing agent.).
OSHA reviewed the UNSCEGHS reports (UN GHS, 2014, Document ID 0087)
on desensitized explosives and has preliminarily concluded that the
hazard class should also be added to the HCS to improve communication
about these hazards. While the chemicals captured by the desensitized
explosives hazard class are currently covered under the scope of the
HCS as explosives, OSHA believes there is a benefit to providing
classification criteria and corresponding hazard communication specific
to this hazard. Adding the proposed new hazard class to the HCS would
ensure downstream users receive more accurate hazard information on
labels and in SDSs for these chemicals.
For these reasons, and to align with the GHS, OSHA proposes to add
the desensitized explosives hazard class to the HCS as appendix B.17.
Proposed appendix B.17 provides relevant definitions and general
considerations, specifies applicable classification criteria, and
includes information about additional classification considerations for
this hazard class. It also references several sections from the UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests
and Criteria that will be incorporated by reference. As with all hazard
classes, the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) does not
require testing and allows classifiers to use data reported in the
literature (UN TDG, 2016, Document ID 0151) that was generated using
specified (or equivalent) test methods. Proposed appendix C.4.30,
discussed later in this document, contains proposed communication
elements for desensitized explosives.
Proposed appendix B.17 is based on Chapter 2.17 of the GHS Rev. 7
(UN GHS, 2017, Document ID 0060). OSHA is proposing to adopt most of
the classification language on desensitized explosives from Chapter
2.17 of the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) to minimize
deviations from the GHS. However, OSHA has carefully reviewed each of
the hazard classification criteria within the context of the HCS and is
proposing to modify some of the language. These edits include changing
some recommendations in the GHS to mandatory requirements in the HCS
(i.e., changing ``should'' to ``shall''); revising some terms in the
GHS to more accurately reflect terminology in the HCS (e.g., changing
``manufacturer/supplier'' to ``manufacturers, importers, and
distributors''); revising text to make it clear that data for
classification can be obtained from the literature; and removing
references to classifications for transportation that do not apply
under the HCS. Some of the GHS text stressing where a classification
scheme is for scenarios other than transportation would also be removed
(e.g., terms referring to storage, supply, and use); this change is
being proposed because the HCS does not cover transportation, and it is
therefore not necessary to include such language in appendix B of the
HCS. OSHA also proposes adding a definition for ``phlegmatized'' in a
[[Page 9712]]
footnote because many stakeholders may be unfamiliar with that term
from the UN Recommendations (UN GHS, 2017, Document ID 0060).
OSHA is not proposing to include portions of the GHS Chapter 2.17
that do not relate specifically to the method of classification for
desensitized explosives; this is the same approach OSHA took in the
2012 update. For example, similar to how OSHA has addressed the other
hazard classes, OSHA is not proposing to adopt the decision logics from
the GHS in appendix B.17; OSHA may, however, use them in guidance
materials. Also, OSHA did not include text relating to hazard
communication in proposed appendix B.17 because this information is
contained in proposed appendix C.
E. Appendix C
OSHA is proposing a number of updates to appendix C of the HCS in
an effort to improve communication of hazard information on labels.
These proposed changes will: (1) Address labeling requirements for the
new hazard classes and categories in appendix B (physical hazards); (2)
align the HCS with the GHS Rev. 7; and (3) improve alignment of the HCS
and Health Canada's labeling requirements in furtherance of the goals
of the RCC.
Appendix C is the mandatory appendix that includes the requirements
and instructions for the allocation of label elements. Paragraph (f)(2)
of the HCS requires the chemical manufacturer, importer, or distributor
to ensure that the information provided on the label is in accordance
with appendix C. Appendix C provides hazard statements, signal words,
pictograms, and precautionary statements for all four essential aspects
of hazardous chemical management (prevention, response, storage and
disposal), as well as general labeling instructions.
As discussed in the 2009 NPRM proposing to align the HCS with the
GHS, the precautionary statements, unlike the hazard statements, were
not harmonized (but were merely codified) under the GHS, meaning that
numbers were assigned to them. This meant that the statements were not
yet considered to be part of the harmonized text (like hazard
statements); rather they were included in the GHS as suggested language
(74 FR 50282-83). OSHA chose to add these statements in the final HCS
rule in 2012 (77 FR 17574). However, since the promulgation of the
updates to the HCS in 2012, the UNSCEGHS has continued work to improve
the utility of precautionary statements by providing better guidance on
the allocation of statements, updating the statements to provide better
protection, and adding new statements for new hazard classes and
categories. OSHA is proposing a number of changes based on new
precautionary statements and instructions in the GHS Rev. 7.
Additionally, since 2012, OSHA has continued to work with other Federal
agencies on crosscutting labeling issues. The updates proposed in
appendix C would ensure alignment with DOT labeling regulations and are
expected to provide the same level of protection for workers as the
current HCS. OSHA is also proposing updates to appendix C based on the
agency's cooperation with Health Canada under the RCC. The RCC was
reaffirmed through a memorandum of understanding that was signed in
June 2018 (RCC, 2019, Document ID 0217), with the expectation of
aligning efforts for international trade requirements between the two
countries.
Overall, OSHA expects that the proposed changes to appendix C would
provide improved safety information and greater detail and clarity for
downstream users. They also would provide better consistency that
bridges the jurisdictional differences between countries and Federal
agencies. Aligning the HCS with the GHS and other Federal or
international regulations would ease compliance burdens for U.S.
stakeholders that must also comply with those requirements. The changes
that OSHA is proposing would lead to improved communication of hazard
information, which would maintain or enhance the safety and health of
workers.
The changes OSHA is proposing to appendix Care extensive. OSHA
addresses the substantive proposed changes in the discussion below, and
a redline strike out version of appendix C, which reflects all of
OSHA's proposed revisions, is available in the docket and on the OSHA
website (OSHA HCS Redline Document, 2020, Document ID 0222; https://www.osha.gov/dsg/hazcom/). This will allow interested parties to view
all of the proposed changes in context. OSHA strongly encourages
stakeholders to review that document in conjunction with the discussion
of the proposed revisions below, as the discussion below does not fully
describe all of the non-substantive or editorial changes OSHA is
proposing.
Proposed Changes to C.1-C.3
The instructions currently found in the beginning of appendix C
(see C.1-C.3) provide directions and information about the signal
words, pictograms, hazard statements and precautionary statements
required per C.4. OSHA is proposing changes to C.1-C.3 to align with
the GHS Rev. 7, better harmonize the HCS with DOT regulations, and
better harmonize the HCS with Health Canada.
First, OSHA proposes to revise Figure C.1--Hazard Symbols and
Classes to include ``HNOC (non-mandatory)'' as a hazard identified by
the exclamation point pictogram. This proposed change reflects OSHA's
agreement with Health Canada to permit the exclamation mark pictogram
to be used for HNOCs. While OSHA does not require labelling for HNOC
hazards, Health Canada requires a pictogram, signal word, hazard
statements, and precautionary statements for HNOCs. In order to ensure
that U.S. and Canadian requirements can simultaneously be met for
HNOCs, OSHA and Health Canada have provided guidance allowing an
exclamation mark pictogram to be used for HNOCs (OSHA, 2016, Document
ID 0103). Use of the exclamation mark pictogram would not be mandatory
under the HCS.
Relatedly, OSHA is proposing a number of additional changes. As
discussed above, OSHA is proposing to move the current C.2.3.3 from
appendix C to paragraph (f)(5) in the text of the standard, so that all
of the instructions related to the transport of hazardous chemicals and
DOT are in one section of the HCS. OSHA is also proposing to add a new
paragraph C.2.3.3, which would allow the exclamation mark pictogram to
be used for HNOCs if the words ``Hazard Not Otherwise Classified'' or
the letters ``HNOC'' appear below the pictogram on the label. Health
Canada and OSHA have agreed that the exclamation mark pictogram is an
appropriate symbol for the HNOC, HHNOC (Health Hazards Not Otherwise
Classified), and PHNOC (Physical Hazards Not Otherwise Classified)
classifications. Additionally, because any pictogram may appear only
once on a label, OSHA is also proposing to add a new paragraph at
C.2.3.4 to specify that if multiple hazards require use of the same
pictogram, it may not appear a second time on the label. This includes
when the exclamation mark pictogram would be used, including as
supplemental information for another hazard, such as HNOC. OSHA is
requesting comments on these proposed changes, and is particularly
interested in comments on whether the agency should require the
exclamation mark pictogram to be used for HNOCs.
The remaining changes proposed for C.2 reflect updates to the GHS
that are intended to provide additional flexibility to the label
preparer while still communicating the required
[[Page 9713]]
information. OSHA is proposing to add new paragraph C.2.4.7 to note
that precautionary statements may contain minor textual variations from
the text prescribed elsewhere in appendix C (e.g., spelling variations,
synonyms or other equivalent terms), as long as those variations assist
in the communication of safety information without diluting or
compromising the safety advice. This proposed new paragraph would also
provide that any variations must be used consistently throughout the
label and SDS. Because of the proposed addition of new paragraph
C.2.4.7, OSHA is also proposing to renumber existing paragraphs C.2.4.7
and C.2.4.8 to become C.2.4.8 and C.2.4.9, respectively.
OSHA is also proposing to add a new paragraph, C.2.4.10, to further
address cases where substances or mixtures may trigger multiple
precautionary statements for medical responses. Consistent with the GHS
Rev. 7 (UN GHS, 2017, Documents ID 0060), OSHA is proposing principles
for addressing situations where a substance or mixture is classified
for a number of hazards and triggers multiple precautionary statements
for medical responses (e.g., calling a poison center/doctor/. . . . and
getting medical advice/attention). Proposed paragraph C.2.4.10 would
provide for a system of prioritization for precautionary statements.
Under proposed C.2.4.10(a), labels would usually need only include one
precautionary statement reflecting the response at the highest level
with the greatest urgency, combined with at least one route of exposure
or symptom ``IF'' statement. For example, the statement, ``Immediately
call a poison center/doctor/. . .'' would be prioritized over the less
urgent ``call a poison center/doctor.''
OSHA believes there is value in including more than one
precautionary statement related to medical response to address both
immediate (acute) and long-term (chronic) medical concerns; appropriate
medical care may be different depending on whether there is a medical
emergency (e.g., chemical burns) or concerns about potential diseases
(e.g., cancer) due to prolonged exposures. However, OSHA also
understands the difficulty involved in providing a long list of medical
responses and that this could lead to confusion, particularly when
immediate action is required. Therefore, proposed paragraph C.2.4.10(b)
would allow for (but not require) combination of medical response
statements. This means that if a chemical has, for example, inhalation
and skin contact hazards that would require the same level of medical
response, both of these routes of entry could be listed in a combined
statement. Proposed paragraph C.2.4.10(c) would prohibit the
combination of medical response statements where the statements ``Get
medical advice/attention if you feel unwell'' and ``Get immediate
medical/advice attention'' are both indicated. In those cases, both
statements should appear without prioritization. OSHA is requesting
comments on whether precautionary statements for medical responses
should be prioritized and seeks input on the best method(s) to use for
prioritization.
Proposed Revisions to C.4
OSHA is proposing to update the hazard label elements for specific
hazard classes and categories. The following discussion on proposed
revisions to C.4 is organized according to: (1) Labeling changes
resulting from the addition of hazard classes and categories in
appendix B (new subcategories for flammable gases (C.4.15), Aerosols
category 3 (C.4.16), and desensitized explosives (C.4.30)); (2)
revisions to hazard statements, hazard categories and notes; (3)
revisions to precautionary statements; and (4) the GHS revisions that
OSHA is not proposing to adopt. In the discussion of precautionary
statements, OSHA will explain the proposed changes to the statements
and indicate what hazard classes/categories trigger these statements.
As noted previously, a redline strike out version of appendix C is
available in the docket and on OSHA's website so interested parties can
see all of the proposed changes in context (OSHA HCS Redline, 2020,
Document ID 0222; https://www.osha.gov/dsg/hazcom/).
Proposed Revisions Based on Additions of Hazard Classes and Categories
OSHA is proposing a number of consequential revisions to appendix C
based on the proposed additions of hazard classes and categories to
appendix B. As discussed in the Summary and Explanation for appendix B,
OSHA is proposing a number of changes to the flammable gas hazard
class. The changes would include: (1) Subdividing category 1 flammable
gases into categories 1A and 1B; (2) adding pyrophoric gases into
category 1A; and (3) adding chemically unstable gases into category 1A
(further subdivided into chemically unstable gas A and chemically
unstable gas B). The proposed hazard and precautionary statements for
those gases, consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060) are in C.4.15. Each type of category 1A gas (including pyrophoric
gases and chemically unstable gases) would require the hazard statement
``Extremely flammable gas,'' as is currently required for category 1
gases. On the other hand, the hazard statement for the new category 1B
flammable gases would be ``Flammable gas.'' Additional hazard and
precautionary statements would be added to communicate hazards specific
to, and precautions that need to be taken for, pyrophoric and
chemically unstable gases.
As also discussed in the Summary and Explanation for appendix B,
OSHA is proposing to add non-flammable aerosols to the existing
``Flammable Aerosols'' hazard class and to rename the class
``Aerosols.'' Consequently, in appendix C, OSHA proposes to adopt the
GHS Rev. 7 (UN GHS, 2017, Document ID 0060) hazard and precautionary
statements for non-flammable aerosols in C.4.16. OSHA believes that
these communication requirements would better address the true hazards
of aerosols. In cases where aerosols are currently labeled as gases
under pressure, the proposal would require the label to be updated to
include the flame pictogram for hazard categories 1 and 2 (no pictogram
would be required for hazard category 3) and the signal word
``warning'' (if ``danger'' is not required due to flammability); the
hazard statement ``pressurized container, may burst if heated'' would
also be required. These changes would better differentiate the hazards
of non-flammable aerosols from those of gases under pressure.
Finally, OSHA is also proposing to adopt the hazard class of
desensitized explosives in appendix B, and consequently to adopt, in
appendix C, the pictogram, signal word, hazard statements, and
precautionary statements for desensitized explosives from the GHS Rev.
7 (UN GHS, 2017, Document ID 0060). Under the proposal, the labeling
information for desensitized explosives would be at C.4.30.
For flammable gases, aerosols, and desensitized explosives, OSHA is
proposing to adopt the GHS Rev. 7 (UN GHS, 2017, Document ID 0060)
hazard communication information with only minor editorial revisions,
such as the use of HCS instead of GHS terminology (e.g.,
``manufacturer, importer or distributor'' instead of ``manufacturer/
supplier or the competent authority'' in conditional instructions).
OSHA believes that the information called for by the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060) effectively communicates the hazards of
those substances and the precautions that need to be taken when
handling them.
[[Page 9714]]
Therefore, requiring the information to appear on labels would improve
hazard communication and enhance worker safety. In addition, because
the changes would align the HCS with the GHS, adopting them would ease
compliance burdens for U.S. stakeholders that must also comply with
international requirements for hazard communication.
Proposed Revisions to Hazard and Precautionary Statements, Hazard
Categories, and Notes
OSHA is proposing to revise a number of hazard and precautionary
statements to align with the GHS Rev. 7. The hazard and precautionary
statements in the current HCS were adopted from the GHS Rev. 3. Since
the HCS was last updated in 2012, the UNSCEGHS has continued to discuss
the utility and readability of the label elements, including hazard and
precautionary statements, in order to improve the information
presented. The specific goals of the UNSCEGHS are to make labeling
information more comprehensible and useable by explaining and
clarifying ambiguous or unhelpful instructions or statements and
eliminating inconsistencies in statements (UN GHS, 2018, Document ID
0095; UN GHS, 2018, Document ID 0213). In addition, the UNSCEGHS is
considering how precautionary statements could be consolidated or
combined to save label space and make labels more readable and clear,
all of which improve the safety message (UN GHS, 2018, Document ID
0095; UN GHS, 2018, Document ID 0213). OSHA shares these goals with the
UNSCEGHS because they lead to better communication of hazards and
therefore maintain or enhance protection of worker safety and health.
Unless otherwise discussed below, OSHA is proposing to adopt the
updated communication information presented in the GHS Rev. 7 (UN GHS,
2017, Document ID 0060) with only minor editorial revisions, such as
using the HCS terminology instead of the GHS terminology (e.g.,
``manufacturer, importer or distributor'' instead of ``manufacturer/
supplier or the competent authority'' in conditional instructions).
Proposed Revisions to Tables C.4.1, C.4.2, and C.4.3 (Acute Toxicity
Tables)
OSHA is proposing to consolidate hazard category information for
acute toxicity--oral, C.4.1. The change would involve deleting the
table for acute toxicity--oral, category 3 and combining categories 1,
2, and 3 in one table, since all three categories have the same
precautionary statements. None of the substantive communication
information for categories 1, 2, or 3 would change, and the intent of
the proposed modification is simply to make C.4.1 more concise.
Proposed Revisions to Precautionary Statements
The original GHS (UN GHS Rev. 1, 2005, Document ID 0215)
precautionary statements were developed from existing classification
systems, including the IPCS International Chemical Safety Card (ICSC)
Compilers Guide (IPCS International, 2012, Document ID 0158), the
American National Standards (ANSI Z129.1 2010, Document ID 0102), the
EU classification and labelling directives, the Emergency Response
Guidebook (UN TDG, 2016, Document ID 0218), and the Pesticide Label
Review Manual of the United States Environmental Protection Agency
(EPA, 2018, Document ID 0056). Since publication of the updates to the
HCS in 2012, the UNSCEGHS has continued its ongoing review of the
precautionary statements to ensure they are allocated to the correct
hazard class and/or category, reduce redundancies, simplify and clarify
the statements, and clarify and refine the conditions of use. This
section discusses OSHA's proposed revisions to precautionary statements
in appendix C.4. The intent or reasons provided below for the proposed
changes reflect OSHA's preliminary agreement with explanations provided
by the UNSCEGHS, unless otherwise specified. The changes are organized
according to the column headings found in the C.4 tables (i.e.,
prevention, response, storage, and disposal).
Proposed Changes in Prevention Column
Wear protective equipment (e.g., gloves/protective clothing).
A precautionary statement for acute toxicity--dermal (categories 1-
4) (Table C.4.2), skin corrosion/irritation (categories 1A-1C) (Table
C.4.4), eye damage/irritation (categories 1 and 2A) (Table C.4.5), and
sensitization--skin (Table C.4.7) specifies personal protective
equipment, such as ``wear protective gloves'' or ``wear eye protection/
face protection.'' Instructions for the statement currently indicate
that the chemical manufacturer, importer, or distributer is ``to
specify type of equipment.'' OSHA proposes to revise the instruction to
state that the chemical manufacturer, importer, or distributor may
further specify type of equipment where appropriate. The intent of this
proposed revision is to clarify that label preparers may provide
additional specification about the type of protective equipment, where
appropriate, and to align with the GHS Rev. 7 (UN GHS, 2017, Document
ID 0060).
Because specific hazards may require specific protective equipment
or instructions, current precautionary statements and instructions for
certain health hazards (e.g., germ cell mutagenicity, see Table C.4.8;
carcinogenicity, see Table C.4.9; and reproductive toxicity, see Table
C.4.10) and the majority of physical hazard classes specify one or more
types of personal protective equipment and indicate that the chemical
manufacturer, importer, or distributor is to specify the type of
equipment. The types of equipment currently listed in the HCS were
adopted from the GHS Rev. 3 and vary for the different hazard classes.
In 2010, the UNSCEGHS recommended that the precautionary statement
``Wear protective gloves/protective clothing/eye protection/face
protection'' be used for the hazard classes of germ cell mutagenicity
(C.4.8), carcinogenicity (C.4.9), reproductive toxicity (C.4.10),
explosives (C.4.14) and unstable explosives (C.4.30) (UN GHS, 2010,
Document ID 0149), and this statement was included in the HCS in 2012.
In 2015, the UNSCEGHS noted that hearing protection should often be
worn when handling explosives and other physical hazards, such as
desensitized explosives, because an explosion would result in a
potentially hazardous noise level (UN GHS, 2015, Document ID 0219).
Accordingly, the UNSCEGHS revised the precautionary statement to read,
``Wear protective gloves/protective clothing/eye protection/face
protection/hearing protection. . .'' (UN GHS, 2016, Document ID 0147).
Adding the term ``/hearing protection. . .'' provides flexibility
because hearing protection and other equipment can be selected when
appropriate and not selected if not relevant. Adding the ellipsis at
the end of the statement allows other types of personal protective
equipment to be listed as necessary. The UNSCEGHS also revised the
instruction for the precautionary statement to make it clear that it is
referring to personal protective equipment. Consistent with the GHS
Rev. 7 (UN GHS, 2017, Document ID 0060) OSHA is proposing to adopt this
revised precautionary statement and instruction for all relevant
hazards: germ cell mutagenicity (C.4.8), categories 1A, 1B, and 2;
carcinogenicity (C.4.9), categories 1A, 1B, and 2; reproductive
toxicity (C.4.10), categories 1A, 1B, and 2; explosives (C.4.14),
[[Page 9715]]
unstable and division 1.1-1.5; flammable gases (C.4.15), category 1A,
pyrophoric; flammable liquids (C.4.19), categories 1, 2, 3, and 4;
flammable solids (C.4.20), categories 1 and 2; self-reactive substances
and mixtures (C.4.21), categories Types A, B, C, D, E, and F;
pyrophoric liquids (C.4.22), category 1; pyrophoric solids (C.4.23),
category 1; self-heating substances and mixtures (C.4.24), categories
1, and 2; substances and mixtures which, in contact with water, emit
flammable gases (C.4.25), categories 1, 2, and 3; oxidizing liquids
(C.4.26), categories 1, 2, and 3; oxidizing solids (C.4.27), categories
1, 2, and 3; organic peroxides (C.4.28), categories Types A, B, C, D,
E, and F; and desensitized explosives (proposed new C.4.30), categories
1, 2, 3, and 4.
Avoid Contact During Pregnancy/While Nursing
In Table C.4.10, for reproductive toxicity (effects on or via
lactation), OSHA is proposing to revise a precautionary statement that
currently says to avoid contact ``during pregnancy/while nursing'' so
it reads ``during pregnancy and while nursing.'' This proposed revision
would clarify that the chemical manufacturer, importer or distributor
is not to choose between ``during pregnancy'' and ``while nursing'' but
is to include both scenarios on the label. This proposed change would
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2012, Document ID 0155).
Do Not Handle Until all Safety Precautions Have Been Read and
Understood
For unstable explosives (Table C.4.14), OSHA is proposing to delete
the precautionary statement about not handling until all safety
precautions have been read and understood. A statement to obtain
special instructions before use is already included and that statement
is shorter and more relevant to safety. This proposed change would
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2012, Document ID 0155).
Do Not Subject to Grinding/Shock/Friction
OSHA also proposes adding the precautionary statement ``Do not
subject to grinding/shock/friction/. . .'' to the table for unstable
explosives (Table C.4.14). That statement is already included for the
other explosives categories, and is also relevant for unstable
explosives. For each of the explosives categories that contain that
statement, an explanatory conditional note clarifying that the
statement applies only if the explosive is mechanically sensitive would
also be added. These proposed changes would align with the GHS Rev. 7
(UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS
2012, Document ID 0153).
Keep Away From Heat/Sparks/Open Flames/Hot Surfaces
A number of the hazard classes that include flammable chemicals
currently require precautionary statements and instructions about
keeping away from ignition sources (heat/sparks/open flames/hot
surfaces). Those statements generally require the chemical
manufacturer, importer, or distributor to select one or more of the
ignition sources listed, as applicable. OSHA is proposing to include
more ignition sources in the statement and to require that they all be
listed on the label. With that change, the statement would read, ``Keep
away from heat, hot surfaces, sparks, open flames, and other ignition
sources.'' OSHA believes this change, which is consistent with the GHS
Rev.7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152),
would improve hazard communication by making users aware of additional
ignition sources that should be avoided. The change would be made to
precautionary statements for explosives (divisions 1.1-1.5 in Table
C.4.14), flammable gases (Table C.4.15), aerosols (Table C.4.16),
flammable liquids (Table C.4.19), flammable solids (Table C.4.20),
self-reactive substances and mixtures (Table C.4.21), pyrophoric
liquids (Table C.4.22), pyrophoric solids (Table C.4.23), oxidizing
liquids (Table C.4.26), oxidizing solids (Table C.4.27), organic
peroxides (Table C.4.28), and desensitized explosives (Table C.4.30).
Keep Wetted With
A conditional instruction used for division 1.1-1.3 and 1.5
explosives in Table C.4.14 currently states that the chemical
manufacturer, importer, or distributer is to include the precautionary
statement ``Keep wetted with. . .'' under conditions where drying would
increase the explosion hazard, except as needed for manufacturing or
operating processes. The GHS Rev. 7 changes the conditional instruction
to clarify that the ``Keep wetted with. . .'' statement should be used
for ``substances or mixtures which are wetted, diluted, dissolved or
suspended with a phlegmatizer to reduce or suppress their explosive
properties'' (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID
0152; UN GHS, 2012, Document ID 0153). OSHA is proposing to make the
same change in order to clarify when the ``Keep wetted with. . .''
statement is appropriate.
The ``Keep wetted with. . .'' precautionary statement also appears
in proposed C.4.30, desensitized explosives. Consistent with the GHS
Rev. 7 (UN GHS, 2017, Document ID 0060), OSHA is not proposing to add
the conditional statement that appears in C.4.14 because, by
definition, desensitized explosives are phlegmatized to suppress their
explosive properties, and therefore the ``Keep wetted with. . .''
statement is appropriate for all desensitized explosives. OSHA requests
comment on these proposed changes.
Keep Only in Original Container
OSHA proposes to revise the statement ``Keep only in original
container'' to ``Keep only in original packaging'' for self-reactive
substances and mixtures (Table C.4.21), organic peroxides (Table
C.4.28), and corrosive to metals (Table C.4.29). The revised statement
would also be added to explosives in division 1.1-1.5 (Table C.4.14).
OSHA believes that this proposed change is appropriate because the term
``packaging'' is more inclusive than ``container'' and would include
the transport packaging as well as the immediate container. These
proposed changes are consistent with the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060; UN GHS, 2012, Document ID 0152).
Ground/Bond Container and Receiving Equipment
Several hazard classes require the precautionary statement
``Ground/bond container and receiving equipment'' for chemicals that
are electrostatically sensitive. OSHA proposes changing ``Ground/bond''
to ``Ground and bond'' to clarify that both of those precautions are to
be included on the label. Appendix C.2.4.2, states that when a ``/'' is
used the label preparer has a choice and should choose the most
appropriate phrase. However, in this case, both ``ground and bond''
should be stated together to appropriately protect against
electrostatically sensitive chemicals. These proposed changes would
apply to explosives (division 1.1-1.5 in Table C.4.14), flammable
liquids (categories 1-3 in Table C.4.19), and flammable solids (Table
C.4.20). In addition, OSHA is proposing to revise existing conditional
instructions to clarify that the need for grounding and bonding applies
to flammable liquids only if they are volatile and may generate an
explosive atmosphere (Table C.4.19) and to
[[Page 9716]]
explosives and flammable solids only if they are electrostatically
sensitive (Tables C.4.14 and C.4.20). OSHA is also proposing to add the
``ground and bond'' precautionary statement and similar conditional
notes (``if electrostatically sensitive and able to generate an
explosive atmosphere'') to self-reactive substances and mixtures (Table
C.4.21) and organic peroxides (Table C.4.28) because the precaution is
also appropriate for those hazard classes. These proposed changes would
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2012, Document ID 0152).
Keep/Store Away From Clothing, and Other Combustible Materials
OSHA is proposing to standardize precautionary statements regarding
combustible materials for oxidizing chemicals. Currently, the tables
for oxidizing gases (Table C.4.17), oxidizing liquids (Table C.4.26,
hazard categories 2 and 3), and oxidizing solids (Table C.4.27, hazard
categories 2 and 3) require the precautionary statement ``Keep/Store
away from clothing/. . . /combustible materials,'' along with
instructions for the chemical manufacturer, importer, or distributor to
specify incompatible materials. OSHA proposes to change the statement
to read: ``Keep away from clothing and other combustible materials,''
and to delete the instruction regarding incompatible materials, to make
the statement more consistent with the statement currently applicable
to hazard category 1 in both oxidizing liquids (Table C.4.26) and
oxidizing solids (Table C.4.27). OSHA believes the proposed change is
appropriate because the general term ``combustible materials''
encompasses any other materials that are incompatible with oxidizers.
In addition, OSHA believes the term ``keep'' is adequate to encompass
storage as well as use, and that eliminating the choice between
``keep'' and ``store'' would avoid confusion and improve consistency.
Finally, OSHA is also proposing to remove the redundant statement
``Take any precaution to avoid mixing with combustibles/. . .'' under
oxidizing liquids (Table C.4.26) and oxidizing solids (Table C.4.27),
since this information is duplicative of the ``keep away from''
statement. These proposed changes are consistent with the GHS Rev. 7
(UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152).
OSHA is proposing to remove the ``keep/store away from clothing/. .
. /combustible materials'' precautionary statement, along with its
instruction, for self-reactive substances and mixtures (Table C.4.21)
and organic peroxides (Table C.4.28). The wording of the precautionary
statement is pertinent to oxidizing properties, which readily give
oxygen or other oxidizing material, and therefore more readily support
combustion. Neither self-reacting chemicals nor organic peroxides have
oxidizing properties, so the statement is not appropriate for them.
Both self-reacting chemicals and organic peroxides have alternate
storage statements that are designed to more accurately address their
particular chemical properties. These proposed changes would also align
with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012,
Document ID 0152; UN GHS, 2012, Document ID 0153).
Keep Valves and Fittings Free From Oil and Grease
For oxidizing gases (Table C.4.17), a precautionary statement
currently allows the chemical manufacturer, importer, or distributor to
specify that either ``reduction valves'' or ``valves and fittings'' be
kept free from oil and grease. OSHA is proposing to revise the
statement to ``Keep valves and fittings free from oil and grease.''
OSHA believes the change is appropriate because all valves and fittings
must be kept free of oil and grease, not just the reduction valves
attached to pressure receptacles. This proposed change is consistent
with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2010,
Document ID 0149).
Wear Cold Insulating Gloves/Face Shield/Eye Protection
OSHA is proposing to revise the precautionary statement for
refrigerated liquefied gases (Table C.4.18), which currently provides
that either cold insulated gloves, a face shield, or eye protection is
to be used. The proposed change would clarify the intent of the
precautionary statement, which is that cold-insulating gloves are to be
used in addition to either a face shield or eye protection. This
proposed change would align with the GHS Rev. 7 (UN GHS, 2017, Document
ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID
0153).
Keep Container Tightly Closed
The precautionary statement ``Keep container tightly closed'' is
used for flammable liquids (categories 1-3 in Table C.4.19). The GHS
Rev. 7 contains a conditional instruction indicating that the statement
is to be used if the liquid is volatile and may generate an explosive
atmosphere (UN GHS, 2017, Document ID 0060). OSHA is proposing to add
this conditional instruction to the precautionary statement for
flammable liquids (categories 1-3) because it clarifies the types of
flammable liquids for which the statement applies.
OSHA also proposes to add the precautionary statement ``Keep
container tightly closed'' to pyrophoric liquids (Table C.4.22) and
pyrophoric solids (Table C.4.23). OSHA believes it is important to add
that statement because for both pyrophoric liquids and pyrophoric
solids it is necessary to avoid ignition via contact with air. Because
the precaution applies to all chemicals in these hazard classes, OSHA
does not believe a conditional note is necessary. These proposed
changes would also align with the GHS, Rev. 7 (UN GHS, 2017, Document
ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID
0153).
Take Precautionary Measures Against Static Discharge
For flammable liquids (Table C.4.19, hazard categories 1-3), OSHA
proposes to revise the precautionary statement ``Take precautionary
measures against static discharge'' to ``Take action to prevent static
discharge.'' The revision would simply shorten the statement and
clarify what action needs to be taken. OSHA also proposes to add a note
that this precautionary statement is to be used if the liquid is
volatile and may generate an explosive atmosphere. These proposed
changes are consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Flammable Liquids/Solids Conditional Instructions
OSHA is proposing additional conditional instructions for flammable
liquids (Table C.4.19) and flammable solids (Table C.4.20). Some
categories of flammable liquids (categories 1-3) and flammable solids
(categories 1 and 2) contain a precautionary statement specifying the
use of ``explosion-proof [electrical/ventilating/lighting/. . .]
equipment.'' OSHA believes that SDS and label creators are not actually
properly and specifically identifying the prevention measures for the
particular chemical, but rather are listing the entire line without the
required details. For liquids, OSHA proposes a new conditional
instruction to clarify that the statement is required if the chemical
is volatile and may generate an explosive atmosphere. For both liquids
and solids, a conditional instruction would be added to indicate that
text in
[[Page 9717]]
square brackets may be used to specify specific electrical,
ventilating, lighting or other equipment if necessary and as
appropriate. These proposed changes would align with the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS,
2012, Document ID 0153).
OSHA is also proposing to add a conditional instruction to the
precautionary statement to use non-sparking tools for flammable liquids
(categories 1-3, Table C.4.19). The statement would clarify that the
precautionary statement is only needed if the liquid is volatile and
may generate an explosive atmosphere, and if the minimum ignition
energy is very low (<0.1 mJ). The precautionary statement has very
limited applicability for flammable liquids and therefore OSHA believes
that the conditions need to be specified. This proposed change is also
consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Keep Cool
For self-reactive substances and mixtures and organic peroxides
(Tables C.4.21 and C.4.28), OSHA is proposing to move the precautionary
statement ``Keep cool'' from the storage column to the prevention
column. The precautionary statement is not needed in the storage column
because that column includes a precautionary statement about storage
temperatures not to be exceeded, and as discussed below, OSHA is
proposing to add conditional instructions to that column to inform
users of when a storage temperature would need to be listed. Under the
prevention column, OSHA is proposing to include a conditional
instruction indicating that the precautionary statement may be omitted
if storage temperatures are included on the label. This proposed
revision would not materially change the information that is presented
on the label, and is consistent with the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012,
Document ID 0153).
For self-heating substances and mixtures (Table C.4.24), a combined
precautionary statement currently instructs the user to keep cool and
protect from sunlight. OSHA is proposing that a conditional instruction
be added to indicate that ``Keep cool'' can be omitted where storage
temperatures are listed on the label. Because ``Protect from sunlight''
still needs to be included if specific storage temperatures are listed
on the label, OSHA is proposing to delete the combined statement under
the prevention column, and to list only ``Keep cool'' (and the new
conditional instruction) in that column. The statement: ``Protect from
sunlight'' would be moved to the storage column, similar to the way
this is handled for other hazard classes. OSHA believes that these
proposed changes would provide the label preparer better instructions
and would provide the appropriate level of information on the label
without repetition. These proposed changes would also align with the
GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID
0152; UN GHS, 2012, Document ID 0153).
Do Not Allow Contact With
OSHA is proposing to add the conditional note ``if emphasis of the
hazard statement is deemed necessary'' to precautionary statements
indicating that contact is not to be allowed with air (for pyrophoric
gases (proposed C.4.15, category 1A), pyrophoric liquids (C.4.22), and
pyrophoric solids (C.4.23)) or water (for substances and mixtures that
emit flammable gases in contact with water (C.4.25, categories 1 and
2). Because the hazard phrases, which are also included on labels for
these categories, already warn about the hazards of these respective
chemicals when they contact air or water, adding this precautionary
statement as well could be repetitive. However, depending on the
specific chemical, the label preparer may feel that added emphasis is
warranted. These proposed changes would align with the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS,
2012, Document ID 0153).
Handle Contents Under Inert Gas
For substances and mixtures which, in contact with water, emit
flammable gases (Table C.4.25), OSHA proposes changing the
precautionary statement ``Handle under inert gas. Protect from
moisture'' to ``Handle and store contents under inert gas/. . . Protect
from moisture.'' This would clarify that these substances should always
be under inert atmospheres. In addition, conditional instructions would
be added to indicate that if the substance or mixture reacts readily
with moisture in air, then the chemical manufacturer, importer or
distributer also has to specify the appropriate liquid or gas if inert
gas is not appropriate. The new statement would provide greater clarity
and is needed because inert gas is not appropriate in some cases (e.g.,
white phosphorus should be handled and stored under water) (UN GHS,
2010, Document ID 0149). This proposed change is consistent with the
GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID
0152; UN GHS, 2012, Document ID 0153).
OSHA is also proposing to add the statement ``Handle and store
contents under inert gas/. . .'' to pyrophoric liquids (C.4.22) and
pyrophoric solids (C.4.23). A conditional statement would note that the
manufacturer, importer, or distributor is to specify the appropriate
liquid or gas if inert gas is not appropriate. Pyrophoric chemicals, by
definition, are likely to ignite when in contact with air. Both Tables
C.4.22 and C.4.23 currently contain the following statement in the
storage column: ``Store contents under . . . Chemical manufacturer,
importer, or distributor to specify appropriate liquid or inert gas.''
In light of the language OSHA is proposing to include in the prevention
column, OSHA would delete this language from the storage column. OSHA
believes that the language being proposed for the prevention column
would emphasize that pyrophoric chemicals must be handled, as well as
stored, under inert atmospheres. OSHA notes that the statements OSHA is
proposing to add to the prevention column for Tables C.4.22 (pyrophoric
liquids) and C.4.23 (pyrophoric solids) regarding handling and storing
contents under inert gas were included in the GHS Rev. 5, but were
inadvertently omitted from Rev. 7 (UN GHS, 2016, Document ID 0211; UN
GHS, 2017, Document ID 0060). If OSHA finalizes the language as
proposed, it will work with the UNSCEGHS to have this statement
reinstated in future GHS revisions.
Wear Fire/Flame Resistant/Retardant Clothing
Category 1 oxidizing liquids (C.4.26) and category 1 oxidizing
solids (C.4.27) currently have the precautionary statement ``Wear fire/
flame resistant/retardant clothing.'' The intent of that statement is
to alert the users of the chemical that they should wear either fire
resistant or flame retardant clothing, not for the label preparer to
choose between the terms ``fire'' and ``flame'' or ``resistant'' and
``retardant''. Therefore, OSHA proposes to replace the existing
statement with ``Wear fire resistant or flame retardant clothing.''
This would clarify the intent of this statement and is consistent with
the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document
ID 0152; UN GHS, 2012, Document ID 0153).
[[Page 9718]]
Proposed Changes in Response Column
For the response column, a number of the proposed revisions in
appendix C are simply editorial and are made to improve clarity,
correct simple omissions of a word or phrase, or more efficiently and
concisely combine different precautionary statements. For example, OSHA
is proposing to add the phrase ``If on skin'' to the statement ``Brush
off loose particles from skin'' (see C.4.23 (pyrophoric solids) and
hazard categories 1 and 2 in C.4.25 (substances and mixtures which, in
contact with water, emit flammable gasses)) because those statements
are always combined in the GHS Rev. 7 (UN GHS, 2017, Document ID 0060),
and the additional phrase would add clarity. Another example is OSHA's
proposal to add the phrase ``In case of fire'' at the beginning of the
precautionary statements related to fire fighting for unstable
explosives, as is already done for other explosives categories (see
C.4.14). In a number of cases, OSHA is proposing to reorganize the
precautionary statements and to remove redundant wording to improve
clarity. For example, in C.4.14, instead of listing the individual
statements and providing conditions of use, OSHA would now list the
statements grouped together (except for materials for Division 1.4S,
which have another set of statements as explained below).
The following discussion does not address proposed changes that are
simply editorial in nature (although all proposed revisions can be
found in the redlined version of appendix C that is available as part
of the rulemaking record (OSHA HCS Redline, 2020, Document ID 0222) and
on OSHA's website (https://www.osha.gov/dsg/hazcom). The discussion
below highlights the substantive changes OSHA is proposing to make to
the response column in appendix C.
Take Off Immediately All Contaminated Clothing. Rinse Skin With Water/
Shower
The existing precautionary statements for skin corrosion/irritation
(categories 1A to 1C in C.4.4) and flammable liquids (categories 1-3 in
C.4.19) indicate that if the chemical is on hair or skin, the affected
individual is to immediately take off all contaminated clothing and
rinse skin with ``water/shower.'' OSHA proposes to revise the statement
to instruct the affected individual to rinse skin with ``water [or
shower],'' and to add a conditional note indicating that the text in
square brackets is to be used where the chemical manufacturer, importer
or distributor considers it appropriate for the specific chemical. The
reason for the proposed change is that a deluge shower might be most
appropriate for the chemical, and the use of the square brackets allows
for selection of the most appropriate wording. The proposed change
would align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN
GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Get Medical Advice/Attention
A number of health hazards (i.e., skin corrosion/irritation
(category 2 in Table C.4.4), eye damage/irritation (categories 2A and
2B in Table C.4.5), sensitization--skin (Table C.4.7), germ cell
mutagenicity (Table C.4.8), carcinogenicity (Table C.4.9), reproductive
toxicity (Table C.4.10), specific target organ toxicity--repeated
exposure (Table C.4.12), and refrigerated liquefied gases (Table
C.4.18)) have combined precautionary statements that include the
statement ``get medical advice/attention.'' OSHA is proposing to add an
instruction indicating that the chemical manufacturer, importer, or
distributer is to select medical advice or attention as appropriate.
This is to alert label preparers that they should provide more specific
instruction on the type of medical assistance needed based on the
chemical hazard and to align with the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060).
If Breathing Is Difficult, Remove Person to Fresh Air and Keep
Comfortable for Breathing
A precautionary statement used for sensitization--respiratory
(Table C.4.6) currently states ``If inhaled: If breathing is difficult,
remove person to fresh air and keep comfortable for breathing.'' OSHA
is proposing to remove the phrase ``if breathing is difficult.'' This
is because including two conditions, ``if inhaled'' and ``if breathing
is difficult,'' is confusing and unnecessary. Removal of the phrase
would also make the precautionary statement consistent with the
statement as it appears in other hazard classes in appendix C.4, such
as acute toxicity--inhalation (Table C.4.3). This proposed change is
consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2010, Document ID 0149).
Take Off Contaminated Clothing and Wash it Before Reuse
A precautionary statement for skin sensitization (Table C.4.7)
currently says to wash contaminated clothing before reuse. OSHA is
proposing to add the phrase ``Take off contaminated clothing and'' to
this precautionary statement. The UNSCEGHS previously recommended that
this additional phrase be used for acute toxicity--dermal; skin
irritation, category 2; and sensitization--skin (UN GHS, 2010, Document
ID 0154). The phrase was inadvertently omitted for skin sensitization
in the GHS Rev. 3 (UN GHS, 2009, Document ID 0085), and accordingly in
the updates to the HCS in 2012, but it has since been added to the GHS
Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2010, Document ID 0149;
UN GHS, 2010, Document ID 0154).
If Exposed or Concerned
For specific target organ toxicity (single exposure) (Table
C.4.11), OSHA is proposing to revise a precautionary statement
indicating ``If exposed'' to ``If exposed or concerned.'' The revision,
which would be consistent with language currently used for the germ
cell mutagenicity (Table C.4.8), carcinogenicity (Table C.4.9), and
reproductive toxicity (Table C.4.10) hazard classes, would maintain
consistency throughout C.4 and with the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060). In 2010, a GHS subcommittee recommended that
wherever ``If exposed'' is used, it be revised to ``If exposed or
concerned,'' since the user of the chemical may not have evidence of
exposure (UN GHS, 2010, Document ID 0154).
Division 1.4 Explosives (C.4.14) Precautionary Statements
For Division 1.4 explosives, the HCS currently provides fire-
fighting precautionary statements and instructions on when to apply
them (Table C.4.14). OSHA is proposing two changes to these statements.
First, OSHA is proposing to change the instruction note from ``for
explosives are 1.4S ammunition and components thereof'' to ``for
explosives of division 1.4 (compatibility group S) in transport
packaging.'' This revision would provide clarity about when the note
applies and there is no intended change in meaning. Second, OSHA is
proposing to revise the precautionary statement ``Fight fire with
normal precautions from a reasonable distance'' to the statement
``Fight fire remotely due to the risk of explosion.'' OSHA believes the
proposed new statement is more appropriate and protective because it
specifies the explosion risk due to fire associated with 1.4
compatibility group S (1.4S) explosives. These proposed changes would
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
[[Page 9719]]
Eliminate All Ignition Sources, if Safe To Do So
For category 1 and 2 flammable gases (C.4.15), a precautionary
statement currently instructs the user to eliminate all ignition
sources if safe to do so. OSHA proposes to revise the statement to ``In
case of leakage, eliminate all ignition sources.'' The term ``in case
of leakage'' would be added to stress that it is important to eliminate
flammable gas leaks, even where the leaking gas is not burning, because
the leak could create an explosive atmosphere. The term ``if safe to do
so'' would be deleted because it could discourage quick action.
Eliminating gas leaks would not be expected where a fire would hinder
that action. OSHA is also proposing to add this statement to pyrophoric
gases 1A and chemically unstable gases A and B. These proposed changes
would be consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060; UNGHS, 2012, Document ID 0152).
In Case of Fire Use . . . To Extinguish
For self-reactive substances and mixtures (type A) (C.4.21), OSHA
is proposing to delete the precautionary statements ``In case of fire
use . . . to extinguish'' (along with its explanatory note) and ``Fight
fire remotely due to the risk of explosion.'' In place of the language
OSHA is proposing to delete, OSHA proposes to use language stating ``In
case of fire: Explosion risk. Do NOT fight fire when fire reaches
explosives.'' These changes would align with the GHS Rev. 7 (UN GHS,
2017, Document ID 0060) and are proposed because it is dangerous to
fight a fire involving this type of material and individuals should
always be advised against it (UN GHS, 2012, Document ID 0152; UN GHS,
2012, Document ID 0153). OSHA is not proposing to change the existing
statement about evacuating the area.
For type B self-reactive substances and mixtures (C.4.21), OSHA is
proposing to combine existing precautionary statements and to delete
duplicate phrases that would occur with the new combination. OSHA does
not intend these changes to alter the meaning of the statements. OSHA
is proposing to use brackets around the statement ``Use . . . to
extinguish'' with a conditional note to indicate that the text in
square brackets is to be included if water increases risk. This is to
preserve the conditions of use with the new combination of phrases.
These proposed changes would align with the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060; UN GHS, 2012, Document ID 0095).
Fire and Explosion Hazards for Organic Peroxides (C.4.28)
Precautionary statements and instructions related to fire and
explosion hazards or fire-fighting procedures were not included in the
GHS Rev. 3 (UN GHS, 2009, Document ID 0085), or in the current HCS, for
organic peroxides (C.4.28). The UNSCEGHS has since adopted these
precautionary statements (UN GHS, 2012, Document ID 0095). As in GHS
Rev. 7 (UN GHS, 2017, Document ID 0060), OSHA is proposing to adopt the
same precautionary statements in the response column for organic
peroxides (C.4.28) as for self-reactive substances and mixtures
(C.4.21). OSHA believes it is appropriate to include these statements
for organic peroxides, as well as for self-reactive substances and
mixtures, because the fire and explosion hazards of the two classes of
compounds are equivalent (UN GHS, 2012, Document ID 0152; UN GHS,
Document ID 0153; UN GHS, 2012, Document ID 0095).
Immerse in Cool Water/Wrap With Wet Bandages
For pyrophoric liquids (C.4.22), pyrophoric solids (C.4.23), and
substances and mixtures which in contact with water emit flammable
gases (C.4.25), a precautionary statement currently indicates that if
the substance is on the skin, the user should ``immerse in cool water/
wrap with wet bandages.'' For pyrophoric liquids (C.4.22) and solids
(C.4.23), OSHA is proposing to change the forward slash to an ``or'' so
that the statement would read ``Immerse in cool water or wrap in wet
bandages.'' The change is proposed to make clear that the chemical
manufacturer, importer, or distributer is not to choose one action or
the other but is to include both actions on the label. In the case of
substances and mixtures which, in contact with water, emit flammable
gases, OSHA is proposing to delete ``wrap in wet bandages'' from the
statement so that the complete statement reads ``Brush off loose
particles from skin and immerse in cool water.'' This change is
proposed because, for these chemicals, a large volume of water is
needed and wrapping in wet bandages is not enough to address problems
caused by the heat of the reaction (UN GHS, 2012, Document ID 0095).
These proposed changes would align with the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012,
Document ID 0153).
Proposed Changes in Storage Column
Store Away From Other Materials
For self-reactive substances and mixtures (C.4.21), self-heating
substances and mixtures (C.4.24), and organic peroxides (C.4.28), OSHA
proposes to revise the precautionary statement ``Store away from other
materials'' to ``Store separately.'' OSHA believes that the revised
statement is preferable because it is shorter and more appropriate.
OSHA is also proposing to add the ``Store separately'' precautionary
statement to category 1 oxidizing liquids (C.4.26) and category 1
oxidizing solids (C.4.27) because those chemicals are not compatible
with other chemicals and thus must be stored separately. These proposed
changes are consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Store Contents Under. . . .
For pyrophoric liquids (C.4.22) and solids (C.4.23), OSHA proposes
to delete a precautionary statement that says ``Store contents under .
. . ,'' along with the instructional note that the chemical
manufacturer, importer, or distributer is to specify the appropriate
liquid or inert gas. The UNSCEGHS recommended that the statement be
deleted from the storage column because it adopted the statement
``Handle and store contents under inert gas/ . . . ,'' along with a
similar instructional note, in the prevention column (UN GHS, 2012,
Document ID 0152; UN GHS, 2012, Document ID 0153). OSHA believes
placing the statement in the prevention column is more appropriate, as
there it would warn the downstream user that pyrophoric chemicals must
be under inert gas not only during storage but at all times, including
during processing and use. This modification was inadvertently omitted
from the text in the GHS Rev. 7, and the U.S. will work with the U.N.
to submit a paper to add this statement to pyrophoric liquids (C.4.22)
and solids (C.4.23) in a future revision of the GHS.
Maintain Air Gap Between Stacks/Pallets
For self-heating substances and mixtures (C.4.24), OSHA is
proposing to revise the precautionary statement that currently says
``[m]aintain air gap between stacks/pallets'' so it reads instead
``[m]aintain air gap between stacks or pallets.'' The change would
clarify that chemical manufacturers, importers or distributors are not
to choose between ``stacks'' or ``pallets''
[[Page 9720]]
but are to include both words on the label. This proposed change would
align with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Store in Corrosive Resistant/ . . . Container With a Resistant Inner
Liner
A precautionary statement for the corrosive to metals (C.4.29)
class currently says to store in a ``corrosive resistant/ . . .
container with a resistant inner liner.'' OSHA is proposing to change
the word ``corrosive'' to ``corrosion'' because it is the technically
correct term. In addition, a new conditional instruction would be
inserted to indicate that the precautionary statement may be omitted if
the statement ``Keep only in original packaging'' is included on the
label. This would eliminate the redundancy of including both
statements. These proposed changes would align with the GHS Rev. 7 (UN
GHS, 2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS,
2012, Document ID 0153).
Instructional Notes
For acute toxicity--inhalation (C.4.3) (category 1-3) and specific
organ toxicity (single exposure, category 3) (C.4.11), OSHA is
proposing minor, non-substantive edits to the conditional instruction
for precautionary statements about keeping the container tightly closed
and storing in a well-ventilated place. OSHA proposes to revise the
note from ``if product is volatile so as to generate hazardous
atmosphere'' to ``if the chemical is volatile and may generate a
hazardous atmosphere.'' The intent of these edits is to improve clarity
and make the instruction more consistent with a newly added instruction
for flammable liquids (C.4.19). This proposed change is consistent with
the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012, Document
ID 0152; UN GHS, 2012, Document ID 0153).
For flammable liquids (C.4.19), OSHA is proposing to add a
clarifying instruction indicating that the precautionary statement
``Store in a well ventilated place. Keep cool'' applies to flammable
liquids in category 1 and other flammable liquids that are volatile and
may generate an explosive atmosphere. However, for category 4 flammable
liquids, OSHA is proposing to delete ``Keep cool,'' because these
liquids are less volatile and have a flashpoint above 60 [deg]C and
therefore are unlikely to generate a hazardous concentration of vapor
during storage; OSHA believes the precautionary statement ``Store in a
well ventilated place'' is the appropriate level of protection. These
proposed changes would align with the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012,
Document ID 0153).
For explosives (C.4.14), OSHA is proposing minor edits to
precautionary statements and instructions for storing in accordance
with local/regional/national/international regulations. The edits are
intended to clarify that the chemical manufacturer, importer, or
distributer is to specify the applicable regulations. These proposed
changes are consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012, Document ID 0153).
Aerosols (C.4.16), self-reactive substances (C.4.21), self-heating
substances and mixtures (C.4.24), and organic peroxides (C.4.28)
currently include precautionary statements addressing storage
temperatures not to be exceeded, with temperatures listed in degrees
Celsius/Fahrenheit. The GHS has added an instruction that the chemical
manufacturer should use the applicable temperature scale for the region
they are supplying (UN GHS, 2017, Document ID 0060; UN GHS, 2012,
Document ID 0152; UN GHS, 2012, Document ID 0153). In other OSHA
standards, the primary temperature scale used is Fahrenheit. Therefore,
OSHA is proposing to require only the Fahrenheit scale in the
precautionary statements. However, the chemical manufacturer, importer
or distributor would still be permitted to include the temperature in
Celsius (as noted by parens ( )) in addition to Fahrenheit.
In addition, for self-reactive substances and mixtures (C.4.21) and
organic peroxides (C.4.28), OSHA proposes to add conditional
instructions to two precautionary statements. The first conditional
instruction would clarify that the statement to store in a well-
ventilated place should not be used for temperature-controlled
substances and mixtures or organic peroxides because condensation and
freezing may occur. The second would clarify that a storage temperature
is only needed if temperature control is required or deemed necessary.
OSHA also proposes moving the precautionary statement ``Keep cool'' to
the prevention column, as discussed above under the section on proposed
changes to the prevention column. These proposed changes would align
with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS, 2012,
Document ID 0152; UN GHS, 2012, Document ID 0153).
Proposed Changes in Disposal Column
For most of the health and physical hazards addressed by appendix
C, the rule currently includes a precautionary statement to dispose of
contents/container in accordance with local/regional/national/
international regulations (to be specified). OSHA is proposing to add
an instructional note in all relevant places in the appendix indicating
that the chemical manufacturer, importer or distributor is to specify
whether the disposal requirements apply to the contents, the container,
or both. This proposed change would align with the GHS Rev. 7 (UN GHS,
2017, Document ID 0060; UN GHS, 2012, Document ID 0152; UN GHS, 2012,
Document ID 0153).
The tables for explosives (C.4.14), except for hazard category
division 1.6, currently include the precautionary statement to dispose
of contents/container in accordance with local/regional/national/
international regulations (to be specified). However, this
precautionary statement may not give users the information needed to
safely dispose of explosives, particularly malfunctioning, expired, or
non-used explosives where special care is needed. This is of particular
concern for explosives such as fireworks, signal flares and ammunition.
Ill-formulated advice on the label may lead to the disposal of such
explosive waste in a way that poses a risk, e.g., to the workers that
handle the waste (UN GHS, 2015, Document ID 0156). Therefore, OSHA is
proposing to change the precautionary note for explosives (C.4.14) to
read: ``Refer to manufacturer, importer, or distributor . . . for
information on disposal, recovery, or recycling.'' An instructional
note would be added to indicate that the chemical manufacturer,
importer, or distributor is to specify the appropriate source of
information, in accordance with local/regional/national/international
regulations as applicable. The change is proposed to address the
recycling or recovery of unexploded fireworks or other unused explosive
cartridges and signal flares, which can result in unsafe conditions and
should only be performed by specialists. This proposed change is
consistent with the GHS Rev. 7 (UN GHS, 2017, Document ID 0060; UN GHS,
2015, Document ID 0214; UN GHS, 2015, Document ID 0213).
Proposed Revisions to Label Elements for OSHA Defined Hazards (C.4.31)
OSHA is proposing a few changes to label elements for OSHA defined
hazards (currently at C.4.30 and proposed to be renumbered as C.4.31).
[[Page 9721]]
This section of appendix C addresses the labeling of hazards that are
not classified under the GHS, but that the HCS specifically defines as
hazards that must be communicated on the label and SDS.
First, OSHA is proposing to delete the entry for ``Pyrophoric
Gas.'' In the GHS Rev. 7, pyrophoric gases are now a category under the
hazard class of flammable gases, and OSHA proposes to include them
there as well.
OSHA is also proposing a change to the ``Combustible Dust'' hazard
statement. When OSHA finalized the revisions to the HCS in 2012, the
GHS did not address classification of combustible dust; however, it
used combustible dust as an example of ``Other hazards which do not
result in classification'' (UN GHS, 2009, Document ID 0085). In the GHS
Rev. 5, the UN updated A.4.3.2.3 to include a statement ``May form
explosible dust-air mixture if dispersed'' for dust explosion hazards
to provide guidance on the type of statement that should be used in the
case of dust explosion hazards (combustible dust) (UN GHS, 2012,
Document ID 0251). Subsequently, OSHA initiated UNSCEGHS discussions
regarding combustible dust hazards. The UNSCEGHS adopted an annex
(Annex 11) that provides additional guidance on hazard identification,
the factors that contribute to a dust explosion hazard, and the need
for risk assessment, prevention, mitigation, and communication (UN GHS,
2017, Document ID 0157). OSHA is now proposing to allow either the
previously required statement, ``may form combustible dust
concentrations in air,'' or the statement suggested in the GHS Annex 4,
``[m]ay form explosible dust-air mixture.'' OSHA is proposing to add
square brackets after both statements containing the following
language: ``if small particles are generated during further processing,
handling or by other means.'' This bracketed language is designed to
indicate that this language should be added when the material can
create a combustible dust hazard during the processing or handling of
the chemical. OSHA is not proposing any changes to the signal word of
``warning'' or any pictogram requirements. These changes are the result
of working papers presented to the UNSCEGHS meetings for discussion in
December of 2017 (UN GHS, 2017, Document ID 0157).
GHS Revisions That OSHA Is Not Proposing To Adopt
There are a small number of revisions in the GHS Rev. 7 that OSHA
is not proposing to adopt for the HCS. In general, OSHA does not
propose to adopt any statements or conditional instructions that
address consumer products because the HCS does not cover communication
of hazards to consumers. This section discusses specific provisions in
the GHS Rev. 7 (UN GHS, 2017, Document ID 0060) that OSHA is not
proposing to adopt.
A number of tables for inhalation hazards in appendix C.4 (i.e.,
acute toxicity--inhalation (C.4.3, categories 3 and 4), respiratory
sensitization (C.4.6), skin sensitization (C.4.7), and specific target
organ toxicity--single exposure (C.4.11, category 3)) contain a
precautionary statement that says ``Avoid breathing dust/fume/gas/mist/
vapors/spray.'' A conditional note in the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060) indicates that this precautionary statement is not
needed where the precautionary statement ``Do not breathe dust/mist/
fume/gas/vapors/spray'' is included on the label. Also, for skin
corrosion/irritation (C.4.4, category 2), the GHS Rev. 7 (UN GHS, 2017,
Document ID 0060) contains a conditional note indicating that the
statement ``If skin irritation occurs: Get medical advice/attention''
may be omitted if the statement ``If skin irritation or rash occurs:
Get medical advice or treatment'' is used. OSHA is not proposing to
adopt these conditional instructions because it believes that proposed
appendix C.2.4.8 (currently C.2.4.7), which provides instructions for
the precedence of precautionary statements, already provides the
necessary flexibility.
In the GHS Rev. 7, the precautionary statements about explosion-
proof equipment and taking action to prevent static discharge include a
conditional instruction indicating that these precautionary statements
can be omitted if national or local legislation contains provisions
that are more specific (UN GHS, 2017, Document ID 0060). OSHA is not
proposing to adopt this instruction because the agency believes these
precautionary statements contain important information that should
always be included on labels. Although some OSHA and consensus
standards address the use of explosion-proof equipment and preventing
static discharge for flammable liquids or solids, they do not address
hazard communication. Therefore, OSHA does not believe they are
specific enough to justify omitting the relevant precautionary
statement from labels. Label preparers can add more specific
supplementary information from standards as long as it complies with
paragraph C.3. For example, they may reference OSHA's flammable liquids
standard (29 CFR 1910.106), which addresses the requirements for
electrical equipment in workplaces that store or handle flammable
liquids. OSHA requests comments on its preliminary decision not to
include the conditional instruction from the GHS.
Under the HCS, a precautionary statement for gases under pressure
(C.4.18) currently says ``Protect from sunlight.'' The GHS Rev. 7
contains a conditional instruction indicating that this precautionary
statement ``may be omitted for gases filled in transportable gas
cylinders in accordance with packing instruction P200 of the UN
Recommendations on the Transport of Dangerous Goods, Model Regulations,
unless those gases are subject to (slow) decomposition or
polymerization, or the competent authority provides otherwise'' (UN
GHS, 2017, Document ID 0060). These special packaging instructions
under P200 are not applicable to cylinders used in the U.S; therefore,
OSHA is not proposing to add this conditional instruction to C.4.18 (UN
GHS, 2017, Document ID 0060).
F. Appendix D
OSHA is proposing several changes to appendix D. These changes are
being proposed to align with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060) to clarify existing requirements where stakeholders have
expressed confusion, and to ensure consistency with updated scientific
principles. A redline strike out version of appendix D, which reflects
all of OSHA's proposed revisions, is available in the docket and on the
OSHA website (OSHA HCS Redline 2020, Document ID 0222); https://www.osha.gov/dsg/hazcom/). This will allow interested parties to view
all of the proposed changes in context. OSHA strongly encourages
stakeholders to review that document in conjunction with the discussion
of the proposed revisions below.
In the introductory section of appendix D, OSHA proposes to add a
sentence stating that while each section of the SDS must contain all of
the specified information, preparers of SDSs are not required to
present the information in any particular order within each section.
OSHA proposes this change to help clarify that while all required
information must be present on the SDS, there are no mandates about the
order in which the information is presented within each section.
Because the information within each section can be listed in any order,
OSHA does not anticipate any increased burden on SDS preparers from
this change.
In section 1, Identification, OSHA is proposing revisions to
clarify that the address and telephone number provided
[[Page 9722]]
on the SDS must be domestic. Although OSHA explained in a 2016 letter
of interpretation that a U.S. telephone number and U.S. address are
required for the SDS and label (Lee, 2016, Document ID 0090), OSHA
believes it is important to codify this requirement in the text of the
HCS to minimize any future confusion.
In section 2, Hazard(s) identification, OSHA is proposing to
clarify where and how chemical hazard information should be presented.
First, OSHA proposes to clarify that paragrah (a) must include any
hazards associated with a change in the chemical's physical form under
normal conditions of use, an issue the agency has addressed in several
LOIs (Cawthorn, 2014, Document ID 0238; McCarthy, 2015, Document ID
0185; Fox, 2008; Document ID 0239). For example, for a chemical that
poses a combustible dust hazard when processed (but not in the form in
which it is shipped), the combustible dust hazard must be included in
section 2(a). OSHA is also proposing a new paragraph (c) covering
hazards identified under normal conditions of use that result from a
chemical reaction (changing the chemical structure of the original
substance or mixture). One example of such a reaction under normal
conditions of use is the chemical change and subsequent physical
effects of adding water to ready-mix concrete or cement, which creates
additional hazards besides those present before the water is added
(MST; 1995, Document ID 0253). This information is already required on
the SDS (Boros, 2014, Document ID 0171), but OSHA believes that adding
this language in paragraph (c) of section 2 would provide a clear and
separate location for chemical manufacturers, distributors and
importers to place this information. To accommodate the new material
being proposed for paragraph (c), OSHA is proposing to move existing
paragraphs (c) and (d) to paragraphs (d) and (e). OSHA notes that if it
adopts the proposed revisions to section 2, hazards associated with
chemicals as shipped, as well as hazards associated with a change in
the chemical's physical form under normal conditions of use, would be
presented in paragraph (a), and new hazards created by a chemical
reaction under normal conditions of use would be presented in paragraph
(c). OSHA believes this would sufficiently differentiates the different
types of hazards presented under normal conditions of use, but welcomes
stakeholder comments on this issue.
In section 3, OSHA is proposing several changes. Under the
subheading ``For Substances (d)'' OSHA is proposing to add
``(constituents)'' to clarify the term ``additives.'' OSHA intends that
any individual part of an ``additive'' that contributes to the
classification of that material needs to be listed in section 3 of the
SDS. OSHA is also proposing to revise the information provided for
mixtures. In addition to the information required for substances,
section 3 requires the chemical name of all ingredients in a mixture
that are classified as health hazards. OSHA proposes also requiring the
CAS number or other unique identifier for these ingredients. CAS
numbers are unique numerical identifiers assigned by the American
Chemical Society (ACS) (CAS, 2020, Document ID 0173). CAS numbers are
internationally recognized as being reliable and readily validated, are
unique to only one compound, substance or chemical, and provide a
common link between various nomenclature that may be used as
descriptors for the substance or compound (UN, 2005, Document ID 0130;
CAS, 2020, Document ID 0173). CAS numbers have been generated for all
substances identified from the scientific literature from 1957 to the
present, with some substances identified as far back as the early 1900s
(CAS, 2020, Document ID 0173; UN, 2005, Document ID 0130). OSHA
believes that this information provides the downstream user with
important information, since it provides a unique descriptor of the
chemical where the chemical identity may be ambiguous.
OSHA is proposing an additional change in section 3 to reflect the
proposed revision to paragraph (i) (Trade secrets), which would allow
for concentration ranges to be withheld as a trade secret. When the
concentration or concentration range is withheld as a trade secret, the
chemical composition range would have to be provided in accordance with
the prescribed concentration ranges in paragraphs (i)(1)(iv)(A) through
(M). As explained in the summary and explanation section for paragraph
(i), this would create an alignment with the WHMIS under Health Canada
(Canadian Gazette II, 2018, Document ID 0101).
Section 8 of the SDS includes information on exposure controls/
personal protection. Section 8(a) currently requires the SDS to include
the OSHA permissible exposure limit (PEL), American Conference of
Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV),
and any other exposure limit used or recommended by the chemical
manufacturer, importer, or employer preparing the SDS, when available.
OSHA has received questions about whether this requirement applies to
individual ingredients and constituents in the mixture, and has
explained that it applies to any ingredient or constituent identified
in section 3 of the SDS (McVeigh, 2013, Document ID 0088). To clarify
this point, OSHA is proposing to revise section 8(a) to state that it
applies to all ingredients or constituents listed in section 3. OSHA
notes, however, that if the ingredient or constituent does not have an
OSHA PEL, ACGIH TLV or any other exposure limit used or recommend by
the SDS preparer, then the ingredient or constituent would not need to
be listed in section 8.
In addition, OSHA is also proposing to revise section 8 to add
language indicating that SDS preparers must also include a ``range'' of
exposure limits whenever a range is used or recommended by the chemical
manufacturer, importer, or employer preparing the SDS. This revision
would acknowledge new tools, such as occupational exposure banding or
hazard banding methods described by NIOSH and the United Kingdom Health
and Safety Executive (NIOSH, 2017, Document ID 0106; HSE, 2013,
Document ID 0104). Hazard banding and occupational exposure banding
provide a concentration range (band) based on toxicity and hazard
information associated with a known chemical with similar properties;
this range can inform appropriate risk management decisions where a
specific occupational exposure limit (OEL) or permissible exposure
limit (PEL) is not available or out of date (NIOSH, 2017, Document ID
0106) This type of information has been developed and validated over
the last few decades and these types of exposure ranges can provide
hazard information on chemicals that can help reduce risk to workers,
even if limited toxicological information is available (NIOSH, 2017,
Document ID 0106). As noted by NIOSH and the U.S. EPA, more than 85,000
chemicals are in commerce, with only approximately one thousand having
been assessed for hazard and toxicity (either through an authoritative
entity or peer-reviewed process) (NIOSH, 2017, Document ID 0106; EPA,
2016, Document ID 0058).
OSHA is proposing several updates to section 9, Physical and
chemical properties. OSHA proposes to revise section 9 to align with
the GHS Rev. 7 by listing the required physical and chemical properties
of the chemical in the same order that appears in the GHS (UN GHS,
2017, Document ID 0060). While OSHA does not require SDS
[[Page 9723]]
preparers to list the physical and chemical properties in any
particular order, the agency is proposing this change in order to
simplify preparation for those chemical manufacturers that may prepare
SDSs for global distribution. Other proposed changes to section 9
include: Replacing ``appearance'' with ``physical state'' and
``color''; eliminating ``odor threshold'' and ``evaporation rate'' as
separate required properties; adding the term ``kinematic'' to the
property ``viscosity'' in order to better define the appropriate
parameter to be characterized (i.e., kinematic as opposed to dynamic
viscosity); and adding ``particle characteristics'' as a new physical
property. Particle characteristics apply to solids only and the
description should include the particle size (median and range) and, if
available and appropriate, further properties such as size distribution
(range), shape and aspect ratio, and specific surface area. Particle
characteristics can be an important indicator of the potential for a
solid particle to pose a hazard as particles that are less than 100
microns increase the likelihood of exposure, especially through the
route of inhalation (UN GHS, 2017, Document ID 0060; UN GHS, 2016;
Document ID 0143, UN GHS, 2014, Document ID 0129).
OSHA is proposing one change to section 10 of the SDS, Stability
and reactivity. Section 10(c) requires preparers to include the
possibility of hazardous reactions, and OSHA is proposing to clarify
that this includes hazardous reactions associated with foreseeable
emergencies. The proposed language is consistent with the language OSHA
is proposing for paragraph (d)(1) (Hazard classification).
In addition, OSHA is proposing to revise section 11, Toxicological
information, to align with the GHS Rev. 7 (UN GHS, 2017, Document ID
0060) by adding interactive effects as paragraph (e). In light of that
proposed change, OSHA is proposing to move existing paragraph (e) to
paragraph (f). OSHA also proposes to add a new paragraph (g), providing
that when specific chemical data or information is not available, SDS
preparers must indicate if alternative information is used and the
method used to derive the information (e.g., where the preparer is
using information from a class of chemicals rather than the exact
chemical in question and using structure activity relationships (SAR)
to derive the toxicological information). SAR and QSAR (quantitative
SAR) are predictive tools that utilize the properties from known
chemical structures and properties in relation to their biological
activity to predict activities and properties of untested chemicals
based on their structural similarity to tested chemicals (EPA, 2016,
Document ID 0179). Read across is another predictive technique that
uses information on an endpoint from a known (tested) substance to
predict endpoint information from a similar (but unknown or untested)
substance (ECHA, 2016, Document ID 0178). Specific, detailed examples
of read across, SAR and QSAR are provided on the OECD's website for
chemical safety--assessment of chemicals (OECD, 2019, Document ID 0091;
EPA, 2016, Document ID 0179; ECHA, 2016, Document ID 0178). This
proposed change reflects the advancement in the scientific application
of computational toxicology to hazard assessment and identification and
would align with the GHS Rev. 7 (Ballabio, 2018, Document ID 0128;
Idakwo, 2020, Document ID 0123; OECD, Document ID 0091; Mangiatoridi,
2016, Document ID 0122; UN GHS, 2017, Document ID 0060).
Finally, OSHA is proposing to change non-mandatory section 14(f),
Transport information, to read ``Transport in bulk according to IMO
instructions'' \60\ instead of ``Transport in bulk (according to Annex
II of MARPOL 73/78 and the IBC Code)'' \61\ to be consistent with text
in the GHS Rev. 7 (IMSBC, 2017, Document ID 0141). This change is an
update to the reference that previously only covered liquefied gases in
bulk. The proposed change would provide guidance that the information
in section 14 covers all bulk transport regardless of the physical form
of the cargo, in accordance with IMO instruments: e.g., Annex II or
Annex V of MARPOL 73/789, the IBC code10, the IMSBC \62\ code and the
IGC \63\ code. This change would also reflect standardization of
conventions for the technology and safety upgrades in the IMO (a global
standard-setting authority for the safety, security and environmental
performance of international shipping under the United Nations).
---------------------------------------------------------------------------
\60\ IMO Means the International Maritime Organization.
\61\ MARPOL means the International Convention for prevention of
Pollution from Ships.
\62\ IMSBC Code means the International Maritime Solid Bulk
Cargoes Code, as amended.
\63\ IGC Code means The International Code of the Construction
and Equipment of Ships Carrying Liquefied Gases in Bulk, as amended.
---------------------------------------------------------------------------
XVI. Authority and Signature
This document was prepared under the direction of Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health, U.S. Department of Labor, 200 Constitution Avenue NW,
Washington, DC 20210. It is issued under the authority of sections 4,
6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C.
653, 655, 657); 5 U.S.C. 553; section 304, Clean Air Act Amendments of
1990 (Pub. L. 101-549, reprinted at 29 U.S.C.A. 655 Note); section 41,
Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); section
107, Contract Work Hours and Safety Standards Act (40 U.S.C. 3704);
section 1031, Housing and Community Development Act of 1992 (42 U.S.C.
4853); section 126, Superfund Amendments and Reauthorization Act of
1986, as amended (reprinted at 29 U.S.C.A. 655 Note); Secretary of
Labor's Order No. 8-2020 (85 FR 58383-94); and 29 CFR part 1911.
List of Subjects in 29 CFR Part 1910
Chemicals, Diseases, Explosives, Flammable materials, Gases,
Hazardous substances, Incorporation by reference, Labeling,
Occupational safety and health, Safety, Signs and symbols.
Signed at Washington, DC, on December 28, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
Proposed Amendments
For the reasons set forth in the preamble, chapter XVII of title
29, part 1910 of the Code of Federal Regulations is proposed to be
amended as follows:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS
0
1. The authority citation for part 1910 continues to read as follows:
Authority: 33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754); 8-76 (41 FR 25059), 9-83 (48
FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), 1-2012 (77 FR 3912), or 08-2020 (85 FR 58393); 29 CFR part
1911; and 5 U.S.C. 553, as applicable.
0
2. Amend Sec. 1910.6 by:
0
a. Revising the last sentence of paragraph (a)(4);
0
b. Adding paragraphs (h)(29) and (r)(2)(vi);
0
c. Redesignating paragraphs (r)(4) and (5) as paragraphs (r)(6) and
(7), redesignating paragraph (r)(3) as paragraph (r)(4), and adding new
paragraphs (r)(3) and (r)(5);
0
d. Revising paragraph (bb); and
0
e. Adding paragraphs (cc) and (dd).
The revisions and additions read as follows:
[[Page 9724]]
Sec. 1910.6 Incorporation by reference.
(a) * * *
(4) * * * For information on the availability of this material at
NARA, email [email protected] or go to www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
(h) * * *
(29) ASTM D 4359-90 (2019), Standard Test Method for Determining
Whether a Material is a Liquid or a Solid, Re-approved 2019, IBR
approved for Sec. 1910.1200.
* * * * *
(r) * * *
(2) * * *
(vi) International Organization for Standardization, ISO Central
Secretariat, Chemin de Blandonnet 8 CP 401--1214 Vernier, Geneva,
Switzerland; Telephone: +41 22 749 01 11; Fax: +41 22 733 34 30; Email:
[email protected]; website: https://www.iso.org/store.html.
(3) ISO 817:2014, Refrigerants--Designation and safety
classification. Third Edition, June, 2014, IBR approved for appendix B
to Sec. 1910.1200.
* * * * *
(5) ISO 10156:2010, Gases and Gas Mixtures--Determination of Fire
Potential and Oxidizing Ability for the Selection of Cylinder Valve
Outlets, Third Edition, April, 2010, IBR approved for appendix B to
Sec. 1910.1200.
* * * * *
(bb) Except as noted, copies of the standards listed in this
paragraph (bb) are available for purchase from United Nations
Publications, P.O. Box 960 Herndon, VA 20172; telephone: 1-703-661-
1571; fax: 1-703-996-1010; email: [email protected].
(1) European Agreement Concerning the International Carriage of
Dangerous Goods by Road (ADR), section 2.3.4 of Annex A, 2019, IBR
approved for Sec. 1910.1200. Website: https://shop.un.org/series/european-agreement-concerning-international-carriage-dangerous-goods-road-adr.
(2) UN ST/SG/AC.10/Rev.4, The UN Recommendations on the Transport
of Dangerous Goods, Manual of Tests and Criteria, Fourth Revised
Edition, 2003, IBR approved for appendix B to Sec. 1910.1200. Copies
available from:
(i) Bernan, 15200 NBN Way, Blue Ridge Summit, PA 17214; telephone:
1-800-865-3457; fax: 1-800-865-3450; email: customercare@bernan;
website: http://www.bernan.com;
(ii) Renouf Publishing Co. Ltd., 812 Proctor Avenue, Ogdensburg, NY
13669-2205; telephone: 1-888-551-7470; Fax: 1-888-551-7471; email:
[email protected]; website: http://www.renoufbooks.com; and
(iii) United Nations Publications, Customer Service, c/o National
Book Network, 15200 NBN Way, P.O. Box 190, Blue Ridge Summit, PA 17214;
telephone: 1-888-254-4286; fax: 1-800-338-4550; email:
[email protected].
(3) UN ST/SG/AC.10/30/Rev.6, The UN Recommendations on the
Transport of Dangerous Goods, Manual of Tests and Criteria, Sixth
Revised Edition, 2015, IBR approved for appendix B to Sec. 1910.1200.
Website: https://www.unece.org/trans/danger/publi/manual/manual_e.html.
(cc) The following material is available for purchase from
International Electrotechnical Commission through ANSI, 25 West 43rd
Street, 4th Floor, New York, NY 10036; telephone: 1-212-642-4963; fax:
1-212-398-0023; website: https://www.iec.ch.
(1) IEC 60079-20-1 ed. 1.0 (2010-01) Explosive atmospheres--Part
20-1: Material characteristics for gas and vapor classification--Test
methods and data, IBR approved for appendix B to Sec. 1910.1200.
(2) [Reserved]
(dd) The following material is available for purchase from German
Institute for Standardization (DIN) through ANSI, 25 West 43rd Street,
4th Floor, New York, NY 10036; telephone: 1-212-642-4963; fax: 1-212-
398-0023; https://din.de/en/about-standards/buy-standard.
(1) DIN 51794--Determining the ignition temperature of petroleum
products, 2003, IBR approved for appendix B to Sec. 1910.1200.
(2) [Reserved]
0
3. Amend Sec. 1910.1200:
0
a. By revising paragraphs (a)(1) and (b)(6)(x);
0
b. In paragraph (c):
0
i. By removing the period following the subject heading and adding a
colon in its place;
0
ii. By adding in alphabetical order definitions for ``Bulk shipment''
and ``Combustible dust'';
0
iii. By revising the definition of ``Exposure or exposed'';
0
iv. By adding in alphabetical order a definition for ``Gas'';
0
v. By revising the definition of ``Hazardous chemical'';
0
vi. By adding in alphabetical order definitions for ``Immediate outer
package'' and ``Liquid'';
0
vii. By revising the definition of ``Physical hazard'';
0
viii. By adding in alphabetical order a definition for ``Physician or
other licensed health are professional (PLHCP)'';
0
ix. By removing the definition of ``Pyrophoric gas''; and
0
x. By adding in alphabetical order definitions for ``Released for
shipment'' and ``Solid'';
0
c. By revising paragraphs (d)(1), (e)(4), and (f)(1), (5), and (11);
0
d. By adding paragraph (f)(12);
0
e. By revising paragraphs (g)(2) introductory text, (g)(10), (i)(1) and
(2), (i)(3) introductory text, and (j); and
0
f. By revising appendices A through D.
The revisions and additions read as follows:
Sec. 1910.1200 Hazard communication.
(a) * * *
(1) The purpose of this section is to ensure that the hazards of
all chemicals produced or imported are classified, and that information
concerning the classified hazards is transmitted to employers and
employees. The requirements of this section are intended to be
consistent with the provisions of the United Nations Globally
Harmonized System of Classification and Labeling of Chemicals (GHS),
Revision 7. The transmittal of information is to be accomplished by
means of comprehensive hazard communication programs, which are to
include container labeling and other forms of warning, safety data
sheets and employee training.
* * * * *
(b) * * *
(6) * * *
(x) Nuisance particulates where the chemical manufacturer or
importer can establish that they do not pose any physical hazard,
health hazard, or other hazards covered under this section;
* * * * *
(c) * * *
Bulk shipment means any hazardous chemical transported where the
mode of transportation (vehicle) comprises the immediate container
(i.e., contained in tanker truck, rail car, or intermodal container).
* * * * *
Combustible dust means finely divided solid particles of a
substance or mixture that are liable to catch fire or explode on
ignition when dispersed in air or other oxidizing media.
* * * * *
Exposure or exposed means that an employee is subjected in the
course of employment to a hazardous chemical, and includes potential
(e.g., accidental or possible) exposure. ``Subjected'' in terms of
health hazards includes any route of entry (e.g., inhalation,
ingestion, skin contact or absorption).
* * * * *
Gas means a substance which--at 122 [deg]F (50 [deg]C) has a vapor
pressure greater than 43.51 PSI (300 kPa) (absolute); or
[[Page 9725]]
is completely gaseous at 68 [deg]F (20 [deg]C) at a standard pressure
of 14.69 PSI (101.3 kPa).
* * * * *
Hazardous chemical means any chemical which is classified as a
physical hazard or a health hazard, a simple asphyxiant, combustible
dust, or hazard not otherwise classified.
* * * * *
Immediate outer package means the first package enclosing the
container of hazardous chemical.
* * * * *
Liquid means a substance or mixture which at 122 [deg]F (50 [deg]C)
has a vapor pressure of not more than 43.51 PSI (300 kPa (3 bar)),
which is not completely gaseous at 68 [deg]F (20 [deg]C) and at a
standard pressure of 101.3 kPa, and which has a melting point or
initial melting point of 68 [deg]F (20 [deg]C) or less at a standard
pressure of 14.69 PSI (101.3 kPa). A viscous substance or mixture for
which a specific melting point cannot be determined shall be subjected
to ASTM D 4359-90 (2019) (Standard Test Method for Determining Whether
a Material Is a Liquid or a Solid) (incorporated by reference; see
Sec. 1910.6); or to the test for determining fluidity (penetrometer
test) prescribed in the European Agreement Concerning the International
Carriage of Dangerous Goods by Road (ADR), section 2.3.4 of Annex A
(2019) (incorporated by reference; see Sec. 1910.6).
* * * * *
Physical hazard means a chemical that is classified as posing one
of the following hazardous effects: Explosive; flammable (gases,
liquids, or solids); aerosols; oxidizer (liquid, solid or gas); self-
reactive; pyrophoric (liquid or solid); self-heating; organic peroxide;
corrosive to metal; gas under pressure; in contact with water emits
flammable gas; or desensitized explosive. The criteria for determining
whether a chemical is classified as a physical hazard are detailed in
appendix B to this section.
Physician or other licensed health care professional (PLHCP) means
an individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows the individual to independently
provide or be delegated the responsibility to provide some or all of
the health care services referenced in paragraph (i) of this section.
* * * * *
Released for shipment means a chemical that has been packaged and
labeled in the manner in which it will be distributed or sold.
* * * * *
Solid means a substance or mixture which does not meet the
definitions of liquid or gas.
* * * * *
(d) * * *
(1) Chemical manufacturers and importers shall evaluate chemicals
produced in their workplaces or imported by them to classify the
chemicals in accordance with this section. For each chemical, the
chemical manufacturer or importer shall determine the hazard classes,
and where appropriate, the category of each class that apply to the
chemical being classified under normal conditions of use and
foreseeable emergencies. The hazard classification shall include any
hazards associated with a change in the chemical's physical form or
resulting from a reaction with other chemicals under normal conditions
of use. Employers are not required to classify chemicals unless they
choose not to rely on the classification performed by the chemical
manufacturer or importer for the chemical to satisfy this paragraph
(d)(1).
* * * * *
(e) * * *
(4) The employer shall make the written hazard communication
program available, upon request, to employees, their designated
representatives, the Assistant Secretary and the Director, in
accordance with the requirements of Sec. 1910.1020(e).
* * * * *
(f) * * *
(1) Labels on shipped containers. The chemical manufacturer,
importer, or distributor shall ensure that each container of hazardous
chemicals leaving the workplace is labeled, tagged or marked. Hazards
not otherwise classified and hazards resulting from a reaction with
other chemicals under normal conditions of use do not have to be
addressed on the container. Where the chemical manufacturer, importer,
or distributor is required to label, tag or mark the following shall be
provided:
(i) Product identifier;
(ii) Signal word;
(iii) Hazard statement(s);
(iv) Pictogram(s);
(v) Precautionary statement(s);
(vi) Name, address, and telephone number of the chemical
manufacturer, importer, or other responsible party; and
(vii) Date chemical is released for shipment.
* * * * *
(5) Transportation. (i) Chemical manufacturers, importers, or
distributors shall ensure that each container of hazardous chemicals
leaving the workplace is labeled, tagged, or marked in accordance with
this section in a manner which does not conflict with the requirements
of the Hazardous Materials Transportation Act (49 U.S.C. 1801 et seq.)
and regulations issued under that Act by the Department of
Transportation.
(ii) The label for bulk shipments of hazardous chemicals may be on
the immediate container or may be transmitted with the shipping papers,
bills of lading, or other technological or electronic means so that it
is immediately available to workers in printed form on the receiving
end of shipment.
(iii) Where a pictogram required by the Department of
Transportation under title 49 of the Code of Federal Regulations
appears on the label for a shipped container, the pictogram specified
in appendix C.4 of this section for the same hazard is not required on
the label.
* * * * *
(11) Release for shipment. Chemical manufacturers, importers,
distributors, or employers who become newly aware of any significant
information regarding the hazards of a chemical shall revise the labels
for the chemical within six months of becoming aware of the new
information, and shall ensure that labels on containers of hazardous
chemicals shipped after that time contain the new information.
Chemicals that have been released for shipment and are awaiting future
distribution need not be relabeled; however, the chemical manufacturer
or importer must provide the updated label for each individual
container with each shipment. If the chemical is not currently produced
or imported, the chemical manufacturer, importer, distributor, or
employer shall add the information to the label before the chemical is
shipped or introduced into the workplace again.
(12) Small container labelling. (i) This paragraph (f)(12) applies
where the chemical manufacturer, importer, or distributor can
demonstrate that it is not feasible to use pull-out labels, fold-back
labels, or tags containing the full label information required by
paragraph (f)(1) of this section.
(ii) For a container less than or equal to 100 ml capacity, the
chemical manufacturer, importer, or distributor must include, at a
minimum, the following information on the label of the container:
(A) Product identifier;
(B) Pictogram(s);
(C) Signal word;
(D) Chemical manufacturer's name and phone number; and
(E) A statement that the full label information for the hazardous
chemical
[[Page 9726]]
is provided on the immediate outer package.
(iii) For a container less than or equal to 3 ml capacity, where
the chemical manufacturer, importer, or distributor can demonstrate
that any label interferes with the normal use of the container, no
label is required, but the container must bear, at a minimum, the
product identifier.
(iv) For all small containers covered by paragraph (f)(12)(ii) or
(iii) of this section, the immediate outer package must include:
(A) The full label information required by paragraph (f)(1) of this
section for each hazardous chemical in the immediate outer package. The
label must not be removed or defaced, as required by paragraph (f)(9)
of this section.
(B) A statement that the small container(s) inside must be stored
in the immediate outer package bearing the complete label when not in
use.
(g) * * *
(2) The chemical manufacturer or importer shall ensure that the
safety data sheet is in English (although the employer may maintain
copies in other languages as well), and includes at least the following
section numbers and headings, and associated information under each
heading, in the order listed (See appendix D to this section for the
specific content of each section of the safety data sheet):
* * * * *
(10) Safety data sheets may be kept in any form, including as
operating procedures, and may be stored in such a way to cover groups
of hazardous chemicals in a work area where it may be more appropriate
to address the hazards of a process rather than individual hazardous
chemicals. However, the employer shall ensure that in all cases the
required information is provided for each hazardous chemical, and is
readily accessible during each work shift to employees when they are in
their work area(s).
* * * * *
(i) * * *
(1) The chemical manufacturer, importer, or employer may withhold
the specific chemical identity, including the chemical name, other
specific identification of a hazardous chemical, or the exact
percentage (concentration) or concentration range of the substance in a
mixture, from section 3 of the safety data sheet, provided that:
(i) The claim that the information withheld is a trade secret can
be supported;
(ii) Information contained in the safety data sheet concerning the
properties and effects of the hazardous chemical is disclosed;
(iii) The safety data sheet indicates that the specific chemical
identity and/or concentration or concentration range of composition is
being withheld as a trade secret;
(iv) If the concentration or concentration range is being claimed
as a trade secret then the safety data sheet provides the ingredient's
concentration as one of the prescribed ranges in paragraphs
(i)(1)(iv)(A) through (M) of this section.
(A) From 0.1% to 1%;
(B) From 0.5% to 1.5%;
(C) From 1% to 5%;
(D) From 3% to 7%;
(E) From 5% to 10%;
(F) From 7% to 13%;
(G) From 10% to 30%;
(H) From 15% to 40%;
(I) From 30% to 60%;
(J) From 45% to 70%;
(K) From 60% to 80%;
(L) From 65% to 85%; and
(M) From 80% to 100%.
(v) The prescribed concentration range used must be the narrowest
range possible. If the exact concentration range falls between 0.1% and
30% and does not fit entirely into one of the prescribed concentration,
a single range created by the combination of two applicable consecutive
ranges (e.g., between (i)(1)(iv)(A) and (G)) may be disclosed instead,
provided that the combined concentration range does not include any
range that falls entirely outside the exact concentration range in
which the ingredient is present.
(vi) The specific chemical identity and exact concentration or
concentration range is made available to health professionals,
employees, and designated representatives in accordance with the
applicable provisions of this paragraph (i).
(2) Where a treating PLHCP determines that a medical emergency
exists and the specific chemical identity and/or specific concentration
or concentration range of a hazardous chemical is necessary for
emergency or first-aid treatment, the chemical manufacturer, importer,
or employer shall immediately disclose the specific chemical identity
or percentage composition of a trade secret chemical to that treating
PLHCP, regardless of the existence of a written statement of need or a
confidentiality agreement. The chemical manufacturer, importer, or
employer may require a written statement of need and confidentiality
agreement, in accordance with the provisions of paragraphs (i)(3) and
(4) of this section, as soon as circumstances permit.
(3) In non-emergency situations, a chemical manufacturer, importer,
or employer shall, upon request, disclose a specific chemical identity
or exact concentration or concentration range, otherwise permitted to
be withheld under paragraph (i)(1) of this section, to a health
professional (e.g., PLHCP, industrial hygienist, toxicologist, or
epidemiologist) providing medical or other occupational health services
to exposed employee(s), and to employees or designated representatives,
if:
* * * * *
(j) Dates. (1) This section is effective [DATE 60 DAYS AFTER DATE
OF PUBLICATION OF FINAL RULE IN THE FEDERAL REGISTER].
(2) Chemical manufacturers, importers, and distributors evaluating
substances shall be in compliance with all modified provisions of this
section no later than [DATE ONE YEAR AFTER EFFECTIVE DATE OF FINAL
RULE].
(3) Chemical manufacturers, importers, and distributors evaluating
mixtures shall be in compliance with all modified provisions of this
section no later than 24 months after [DATE TWO YEARS AFTER EFFECTIVE
DATE OF FINAL RULE].
* * * * *
Appendix A to Sec. 1910.1200--Health Hazard Criteria (Mandatory)
A.0 General Classification Considerations
A.0.1 Classification
A.0.1.1 The term ``hazard classification'' is used to indicate
that only the intrinsic hazardous properties of chemicals are
considered. Hazard classification incorporates three steps:
(a) Identification of relevant data regarding the hazards of a
chemical;
(b) Subsequent review of those data to ascertain the hazards
associated with the chemical;
(c) Determination of whether the chemical will be classified as
hazardous and the degree of hazard.
A.0.1.2 For many hazard classes, the criteria are semi-
quantitative or qualitative and expert judgment is required to
interpret the data for classification purposes.
A.0.1.3 Where impurities, additives or individual constituents
of a substance or mixture have been identified and are themselves
classified, they should be taken into account during classification
if they exceed the cut-off value/concentration limit for a given
hazard class.
A.0.2 Available Data, Test Methods and Test Data Quality
A.0.2.1 There is no requirement for testing chemicals.
A.0.2.2 The criteria for determining health hazards are test
method neutral, i.e., they do not specify particular test methods,
as long as the methods are scientifically validated.
[[Page 9727]]
A.0.2.3 The term ``scientifically validated'' refers to the
process by which the reliability and the relevance of a procedure
are established for a particular purpose. Any test that determines
hazardous properties, which is conducted according to recognized
scientific principles, can be used for purposes of a hazard
determination for health hazards. Test conditions need to be
standardized so that the results are reproducible with a given
substance, and the standardized test yields ``valid'' data for
defining the hazard class of concern.
A.0.2.4 Existing test data are acceptable for classifying
chemicals, although expert judgment also may be needed for
classification purposes.
A.0.2.5 The effect of a chemical on biological systems is
influenced, by the physico-chemical properties of the substance and/
or ingredients of the mixture and the way in which ingredient
substances are biologically available. A chemical need not be
classified when it can be shown by conclusive experimental data from
scientifically validated test methods that the chemical is not
biologically available.
A.0.2.6 For classification purposes, epidemiological data and
experience on the effects of chemicals on humans (e.g., occupational
data, data from accident databases) shall be taken into account in
the evaluation of human health hazards of a chemical.
A.0.3 Classification Based on Weight of Evidence
A.0.3.1 For some hazard classes, classification results directly
when the data satisfy the criteria. For others, classification of a
chemical shall be determined on the basis of the total weight of
evidence using expert judgment. This means that all available
information bearing on the classification of hazard shall be
considered together, including the results of valid in vitro tests,
relevant animal data, and human experience such as epidemiological
and clinical studies and well-documented case reports and
observations.
A.0.3.2 The quality and consistency of the data shall be
considered. Information on chemicals related to the material being
classified shall be considered as appropriate, as well as site of
action and mechanism or mode of action study results. Both positive
and negative results shall be considered together in a single
weight-of-evidence determination.
A.0.3.3 Positive effects which are consistent with the criteria
for classification, whether seen in humans or animals, shall
normally justify classification. Where evidence is available from
both humans and animals and there is a conflict between the
findings, the quality and reliability of the evidence from both
sources shall be evaluated in order to resolve the question of
classification. Reliable, good quality human data shall generally
have precedence over other data. However, even well-designed and
conducted epidemiological studies may lack a sufficient number of
subjects to detect relatively rare but still significant effects, or
to assess potentially confounding factors. Therefore, positive
results from well-conducted animal studies are not necessarily
negated by the lack of positive human experience but require an
assessment of the robustness, quality and statistical power of both
the human and animal data.
A.0.3.4 Route of exposure, mechanistic information, and
metabolism studies are pertinent to determining the relevance of an
effect in humans. When such information raises doubt about relevance
in humans, a lower classification may be warranted. When there is
scientific evidence demonstrating that the mechanism or mode of
action is not relevant to humans, the chemical should not be
classified.
A.0.3.5 Both positive and negative results are considered
together in the weight of evidence determination. However, a single
positive study performed according to good scientific principles and
with statistically and biologically significant positive results may
justify classification.
A.0.4 Considerations for the Classification of Mixtures
A.0.4.1 Except as provided in A.0.4.2, the process of
classification of mixtures is based on the following sequence:
(a) Where test data are available for the complete mixture, the
classification of the mixture will always be based on those data;
(b) Where test data are not available for the mixture itself,
the bridging principles designated in each health hazard chapter of
this appendix shall be considered for classification of the mixture;
(c) If test data are not available for the mixture itself, and
the available information is not sufficient to allow application of
the above-mentioned bridging principles, then the method(s)
described in each chapter for estimating the hazards based on the
information known will be applied to classify the mixture (e.g.,
application of cut-off values/concentration limits).
A.0.4.2 An exception to the above order or precedence is made
for Carcinogenicity, Germ Cell Mutagenicity, and Reproductive
Toxicity. For these three hazard classes, mixtures shall be
classified based upon information on the ingredient substances,
unless on a case-by-case basis, justification can be provided for
classifying based upon the mixture as a whole. See chapters A.5,
A.6, and A.7 for further information on case-by-case bases.
A.0.4.3 Use of cut-off values/concentration limits
A.0.4.3.1 When classifying an untested mixture based on the
hazards of its ingredients, cut-off values/concentration limits for
the classified ingredients of the mixture are used for several
hazard classes. While the adopted cut-off values/concentration
limits adequately identify the hazard for most mixtures, there may
be some that contain hazardous ingredients at lower concentrations
than the specified cut-off values/concentration limits that still
pose an identifiable hazard. There may also be cases where the cut-
off value/concentration limit is considerably lower than the
established non-hazardous level for an ingredient.
A.0.4.3.2 If the classifier has information that the hazard of
an ingredient will be evident (i.e., it presents a health risk)
below the specified cut-off value/concentration limit, the mixture
containing that ingredient shall be classified accordingly.
A.0.4.3.3 In exceptional cases, conclusive data may demonstrate
that the hazard of an ingredient will not be evident (i.e., it does
not present a health risk) when present at a level above the
specified cut-off value/concentration limit(s). In these cases the
mixture may be classified according to those data. The data must
exclude the possibility that the ingredient will behave in the
mixture in a manner that would increase the hazard over that of the
pure substance. Furthermore, the mixture must not contain
ingredients that would affect that determination.
A.0.4.4 Synergistic or antagonistic effects
When performing an assessment in accordance with these
requirements, the evaluator must take into account all available
information about the potential occurrence of synergistic effects
among the ingredients of the mixture. Lowering classification of a
mixture to a less hazardous category on the basis of antagonistic
effects may be done only if the determination is supported by
sufficient data.
A.0.5 Bridging principles for the classification of mixtures
where test data are not available for the complete mixture
A.0.5.1 Where the mixture itself has not been tested to
determine its toxicity, but there are sufficient data on both the
individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data shall be used in
accordance with the following bridging principles, subject to any
specific provisions for mixtures for each hazard class. These
principles ensure that the classification process uses the available
data to the greatest extent possible in characterizing the hazards
of the mixture.
A.0.5.1.1 Dilution
For mixtures classified in accordance with A.1 through A.10 of
this appendix, if a tested mixture is diluted with a diluent that
has an equivalent or lower toxicity classification than the least
toxic original ingredient, and which is not expected to affect the
toxicity of other ingredients, then:
(a) The new diluted mixture shall be classified as equivalent to
the original tested mixture; or
(b) For classification of acute toxicity in accordance with A.1
of this appendix, paragraph A.1.3.6 (the additivity formula) shall
be applied.
A.0.5.1.2 Batching
For mixtures classified in accordance with A.1 through A.10 of
this appendix, the toxicity of a tested production batch of a
mixture can be assumed to be substantially equivalent to that of
another untested production batch of the same mixture, when produced
by or under the control of the same chemical manufacturer, unless
there is reason to believe there is significant variation such that
the toxicity of the untested batch has changed. If the latter
occurs, a new classification is necessary.
A.0.5.1.3 Concentration of mixtures
For mixtures classified in accordance with A.1, A.2, A.3, A.4,
A.8, A.9, or A.10 of this appendix, if a tested mixture is
classified in Category 1, and the concentration of the
[[Page 9728]]
ingredients of the tested mixture that are in Category 1 is
increased, the resulting untested mixture shall be classified in
Category 1.
A.0.5.1.4 Interpolation within one hazard category
For mixtures classified in accordance with A.1, A.2, A.3, A.4,
A.8, A.9, or A.10 of this appendix, for three mixtures (A, B and C)
with identical ingredients, where mixtures A and B have been tested
and are in the same hazard category, and where untested mixture C
has the same toxicologically active ingredients as mixtures A and B
but has concentrations of toxicologically active ingredients
intermediate to the concentrations in mixtures A and B, then mixture
C is assumed to be in the same hazard category as A and B.
A.0.5.1.5 Substantially similar mixtures
For mixtures classified in accordance with A.1 through A.10 of
this appendix, given the following set of conditions:
(a) Where there are two mixtures: (i) A + B; (ii) C + B;
(b) The concentration of ingredient B is essentially the same in
both mixtures;
(c) The concentration of ingredient A in mixture (i) equals that
of ingredient C in mixture (ii);
(d) And data on toxicity for A and C are available and
substantially equivalent; i.e., they are in the same hazard category
and are not expected to affect the toxicity of B; then
If mixture (i) or (ii) is already classified based on test data,
the other mixture can be assigned the same hazard category.
A.0.5.1.6 Aerosols
For mixtures classified in accordance with A.1, A.2, A.3, A.4,
A.8, or A.9 of this appendix, an aerosol form of a mixture shall be
classified in the same hazard category as the tested, non-
aerosolized form of the mixture, provided the added propellant does
not affect the toxicity of the mixture when spraying.
A.1 Acute Toxicity
A.1.1 Definition
Acute toxicity refers to serious adverse health effects (i.e.,
lethality) occurring after a single or short-term oral, dermal, or
inhalation exposure to a substance or mixture.
A.1.2 Classification Criteria for Substances
A.1.2.1 Substances can be allocated to one of four hazard
categories based on acute toxicity by the oral, dermal or inhalation
route according to the numeric cut-off criteria as shown in Table
A.1.1. Acute toxicity values are expressed as (approximate) LD50
(oral, dermal) or LC50 (inhalation) values or as acute toxicity
estimates (ATE). While some in vivo methods determine
LD50/LC50 values directly, other newer in vivo
methods (e.g., using fewer animals) consider other indicators of
acute toxicity, such as significant clinical signs of toxicity,
which are used by reference to assign the hazard category. See the
footnotes following Table A.1.1 for further explanation on the
application of these values.
[[Page 9729]]
[GRAPHIC] [TIFF OMITTED] TP16FE21.077
A.1.2.3 The preferred test species for evaluation of acute
toxicity by the oral and inhalation routes is the rat, while the rat
or rabbit are preferred for evaluation of acute dermal toxicity.
Test data already generated for the classification of chemicals
under
[[Page 9730]]
existing systems should be accepted when reclassifying these
chemicals under the harmonized system. When experimental data for
acute toxicity are available in several animal species, scientific
judgment should be used in selecting the most appropriate
LD50 value from among scientifically validated tests. In
cases where data from human experience (i.e., occupational data,
data from accident databases, epidemiology studies, clinical
reports) is also available, it should be considered in a weight of
evidence approach consistent with the principles described in A.0.3.
A.1.2.4 In addition to classification for inhalation toxicity,
if data are available that indicates that the mechanism of toxicity
was corrosivity of the substance or mixture, the classifier must
consider if the chemical is corrosive to the respiratory tract.
Corrosion of the respiratory tract is defined as destruction of the
respiratory tract tissue after a single, limited period of exposure
analogous to skin corrosion; this includes destruction of the
mucosa. The corrosivity evaluation could be based on expert judgment
using such evidence as: Human and animal experience, existing (in
vitro) data, pH values, information from similar substances or any
other pertinent data.
A.1.2.4.1 If the classifier determines the chemical is corrosive
to the respiratory tract and data are available that indicate that
the effect leads to lethality, then the chemical must be labelled
with the hazard statement ``corrosive to the respiratory tract.''
A.1.2.4.2 If the classifier determines the chemical is corrosive
to the respiratory tract and the effect does not lead to lethality,
then the chemical must be addressed in the Specific Target Organ
Toxicity hazard classes (see A.8 and A.9).
A.1.3 Classification Criteria for Mixtures
A.1.3.1 The approach to classification of mixtures for acute
toxicity is tiered, and is dependent upon the amount of information
available for the mixture itself and for its ingredients. The flow
chart of Figure A.1.1 indicates the process that must be followed:
[GRAPHIC] [TIFF OMITTED] TP16FE21.080
[[Page 9731]]
A.1.3.2 Classification of mixtures for acute toxicity may be
carried out for each route of exposure, but is only required for one
route of exposure as long as this route is followed (estimated or
tested) for all ingredients and there is no relevant evidence to
suggest acute toxicity by multiple routes. When there is relevant
evidence of acute toxicity by multiple routes of exposure,
classification is to be conducted for all appropriate routes of
exposure. All available information shall be considered. The
pictogram and signal word used shall reflect the most severe hazard
category; and all relevant hazard statements shall be used.
A.1.3.3 For purposes of classifying the hazards of mixtures in
the tiered approach:
(a) The ``relevant ingredients'' of a mixture are those which
are present in concentrations >=1% (weight/weight for solids,
liquids, dusts, mists and vapors and volume/volume for gases). If
there is reason to suspect that an ingredient present at a
concentration <1% will affect classification of the mixture for
acute toxicity, that ingredient shall also be considered relevant.
Consideration of ingredients present at a concentration <1% is
particularly important when classifying untested mixtures which
contain ingredients that are classified in Category 1 and Category
2;
(b) Where a classified mixture is used as an ingredient of
another mixture, the actual or derived acute toxicity estimate (ATE)
for that mixture is used when calculating the classification of the
new mixture using the formulas in A.1.3.6.1 and A.1.3.6.2.4.
(c) If the converted acute toxicity point estimates for all
ingredients of a mixture are within the same category, then the
mixture should be classified in that category.
(d) When only range data (or acute toxicity hazard category
information) are available for ingredients in a mixture, they may be
converted to point estimates in accordance with Table A.1.2 when
calculating the classification of the new mixture using the formulas
in A.1.3.6.1 and A.1.3.6.2.4.
A.1.3.4 Classification of Mixtures Where Acute Toxicity Test Data
Are Available for the Complete Mixture
Where the mixture itself has been tested to determine its acute
toxicity, it is classified according to the same criteria as those
used for substances, presented in Table A.1.1. If test data for the
mixture are not available, the procedures presented below must be
followed.
A.1.3.5 Classification of Mixtures Where Acute Toxicity Test Data
Are Not Available for the Complete Mixture: Bridging Principles
A.1.3.5.1 Where the mixture itself has not been tested to
determine its acute toxicity, but there are sufficient data on both
the individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data will be used in
accordance with the following bridging principles as found in
paragraph A.0.5 of this appendix: Dilution, Batching, Concentration
of mixtures, Interpolation within one hazard category, Substantially
similar mixtures, and Aerosols.
A.1.3.6 Classification of Mixtures Based on Ingredients of the
Mixture (Additivity Formula)
A.1.3.6.1 Data available for all ingredients.
The acute toxicity estimate (ATE) of ingredients is considered
as follows:
(a) *Include ingredients with a known acute toxicity, which fall
into any of the acute toxicity hazard categories, or have an oral or
dermal LD50 greater than 2,000 but less than or equal to
5,000 mg/kg body weight (or the equivalent dose for inhalation);
(b) Ignore ingredients that are presumed not acutely toxic
(e.g., water, sugar);
(c) Ignore ingredients if the data available are from a limit
dose test (at the upper threshold for Category 4 for the appropriate
route of exposure as provided in Table A.1.1) and do not show acute
toxicity.
Ingredients that fall within the scope of this paragraph are
considered to be ingredients with a known acute toxicity estimate
(ATE). See note (b) to Table A.1.1 and paragraph A.1.3.3 for
appropriate application of available data to the equation below, and
paragraph A.1.3.6.2.4.
The ATE of the mixture is determined by calculation from the ATE
values for all relevant ingredients according to the following
formula below for oral, dermal or inhalation toxicity:
[GRAPHIC] [TIFF OMITTED] TP16FE21.081
where:
Ci = concentration of ingredient i
n ingredients and i is running from 1 to n
ATEi = acute toxicity estimate of ingredient i.
A.1.3.6.2 Data are not available for one or more ingredients of
the mixture
A.1.3.6.2.1 Where an ATE is not available for an individual
ingredient of the mixture, but available information provides a
derived conversion value, the formula in A.1.3.6.1 may be applied.
This information may include evaluation of:
(a) Extrapolation between oral, dermal and inhalation acute
toxicity estimates. Such an evaluation requires appropriate
pharmacodynamic and pharmacokinetic data;
(b) Evidence from human exposure that indicates toxic effects
but does not provide lethal dose data;
(c) Evidence from any other toxicity tests/assays available on
the substance that indicates toxic acute effects but does not
necessarily provide lethal dose data; or
(d) Data from closely analogous substances using structure/
activity relationships.
A.1.3.6.2.2 This approach requires substantial supplemental
technical information, and a highly trained and experienced expert,
to reliably estimate acute toxicity. If sufficient information is
not available to reliably estimate acute toxicity, proceed to the
provisions of A.1.3.6.2.4.
A.1.3.6.2.3 In the event that an ingredient with unknown acute
toxicity is used in a mixture at a concentration >=1%, and the
mixture has not been classified based on testing of the mixture as a
whole, the mixture cannot be attributed a definitive acute toxicity
estimate. In this situation the mixture is classified based on the
known ingredients only. Note: A statement that x percent of the
mixture consists of ingredient(s) of unknown acute (oral/dermal/
inhalation) toxicity is required on the label and safety data sheet
in such cases; see appendix C to this section, Allocation of Label
Elements and appendix D to this section, Safety Data Sheets.)
A.1.3.6.2.4 If the total concentration of the relevant
ingredient(s) with unknown acute toxicity is <=10% then the formula
presented in A.1.3.6.1 must be used. If the total concentration of
the relevant ingredient(s) with unknown acute toxicity is >10%, the
formula presented in A.1.3.6.1 is corrected to adjust for the
percentage of the unknown ingredient(s) as follows:
[GRAPHIC] [TIFF OMITTED] TP16FE21.082
A.2 Skin Corrosion/Irritation
A.2.1 Definitions and General Considerations
A.2.1.1 Skin corrosion refers to the production of irreversible
damage to the skin; namely, visible necrosis through the epidermis
and into the dermis occurring after exposure to a substance or
mixture.
Skin irritation refers to the production of reversible damage to
the skin occurring after exposure to a substance or mixture.
A.2.1.2 Skin corrosion/irritation shall be classified using a
tiered approach as detailed in figure A.2.1. Emphasis shall be
placed upon existing human data (See A.0.2.6), followed by existing
animal data, followed by in vitro data and then other sources of
information. Classification results directly when the data satisfy
the criteria in this section. In case the criteria cannot be
directly applied, classification of a substance or a mixture is made
on the basis of the total weight of evidence (See A.0.3.1). This
means that all available information bearing on the determination of
skin corrosion/irritation is considered together, including the
results of appropriate scientifically validated in-vitro tests,
relevant animal data, and human data
[[Page 9732]]
such as epidemiological and clinical studies and well-documented
case reports and observations.
A.2.2 Classification Criteria for Substances
Substances shall be allocated to one of the following categories
within this hazard class:
(a) Category 1 (skin corrosion)
This category may be further divided into up to three sub-
categories (1A, 1B and 1C)
(b) Category 2 (skin irritation)
A.2.2.1 Classification Based on Standard Animal Test Data
A.2.2.1.1 Skin Corrosion
A.2.2.1.2 A substance is corrosive to the skin when it produces
destruction of skin tissue, namely, visible necrosis through the
epidermis and into the dermis, in at least one tested animal after
exposure up to a 4-hour duration.
A.2.2.1.3 Three sub-categories of Category 1 are provided in
Table A.2.1, all of which shall be regulated as Category 1.
Table A.2.1--Skin Corrosion Category and Sub-Categories \a\
------------------------------------------------------------------------
Criteria
------------------------------------------------------------------------
Category 1.............................. Destruction of skin tissue,
namely, visible necrosis
through the epidermis and
into the dermis, in at least
one tested animal after
exposure <=4 h.
Sub-category 1A......................... Corrosive responses in at
least one animal following
exposure <=3 min during an
observation period <=1 h.
Sub-category 1B......................... Corrosive responses in at
least one animal following
exposure >3 min and <=1 h and
observations <=14 days.
Sub-category 1C......................... Corrosive responses in at
least one animal after
exposures >1 h and <=4 h and
observations <=14 days.
------------------------------------------------------------------------
\a\ The use of human data is discussed in A.2.3.
A.2.2.2 Skin Irritation
A.2.2.2.1 A single irritant category (Category 2) is presented
in the Table A.2.2. A substance is irritant to skin when it produces
reversible damage to the skin following its application for up to 4
hours.
The major criterion for the irritant category is that at least 2
tested animals have a mean score of >=2.3 <=4.0.
A.2.2.2.2 An irritation category (Category 2) is provided that:
(a) Recognizes that some test substances may lead to effects
which persist throughout the length of the test; and
(b) acknowledges that animal responses in a test may be
variable.
A.2.2.2.3 Reversibility of skin lesions is another consideration
in evaluating irritant responses. When inflammation persists to the
end of the observation period in two or more test animals, taking
into consideration alopecia (limited area), hyperkeratosis,
hyperplasia and scaling, then a chemical should be considered to be
an irritant.
A.2.2.2.4 Animal irritant responses within a test can be quite
variable, as they are with corrosion. A separate irritant criterion
accommodates cases when there is a significant irritant response but
less than the mean score criterion for a positive test. For example,
a substance might be designated as an irritant if at least 1 of 3
tested animals shows a very elevated mean score throughout the
study, including lesions persisting at the end of an observation
period of normally 14 days. Other responses could also fulfill this
criterion. However, it should be ascertained that the responses are
the result of chemical exposure. Addition of this criterion
increases the sensitivity of the classification system.
Table A.2.2--Skin Irritation Category a b
------------------------------------------------------------------------
Criteria
------------------------------------------------------------------------
Irritant (Category 2)................... (1) Mean score of >=2.3 <=4.0
for erythema/eschar or for
edema in at least 2 of 3
tested animals from gradings
at 24, 48 and 72 hours after
patch removal or, if
reactions are delayed, from
grades on 3 consecutive days
after the onset of skin
reactions; or
(2) Inflammation that persists
to the end of the observation
period normally 14 days in at
least 2 animals, particularly
taking into account alopecia
(limited area),
hyperkeratosis, hyperplasia,
and scaling; or
(3) In some cases where there
is pronounced variability of
response among animals, with
very definite positive
effects related to chemical
exposure in a single animal
but less than the criteria
above.
------------------------------------------------------------------------
\a\ Grading criteria are understood as described in OECD Test Guideline
404.
A.2.3 Classification in a Tiered Approach
A.2.3.1 A tiered approach to the evaluation of initial
information shall be used (Figure A.2.1) recognizing that not all
elements may be relevant.
A.2.3.2 Existing human and animal data including information
from single or repeated exposure should be the first line of
evaluation, as they give information directly relevant to effects on
the skin.
A.2.3.3 Acute dermal toxicity data may be used for
classification. If a substance is highly toxic by the dermal route,
a skin corrosion/irritation study may not be practicable since the
amount of test substance to be applied would considerably exceed the
toxic dose and, consequently, would result in the death of the
animals. When observations are made of skin corrosion/irritation in
acute toxicity studies and are observed up through the limit dose,
these data may be used for classification provided that the
dilutions used and species tested are equivalent. Solid substances
(powders) may become corrosive or irritant when moistened or in
contact with moist skin or mucous membranes.
A.2.3.4 In vitro alternatives that have been scientifically
validated shall be used to make classification decisions.
A.2.3.5 Likewise, pH extremes like <=2 and >=11.5 may indicate
skin effects, especially when associated with significant acid/
alkaline reserve (buffering capacity). Generally, such substances
are expected to produce significant effects on the skin. In the
absence of any other information, a substance is considered
corrosive (Skin Category 1) if it has a pH <=2 or a pH >=11.5.
However, if consideration of acid/alkaline reserve suggests the
substance or mixture may not be corrosive despite the low or high pH
value, this needs to be confirmed by other data, preferably data
from an appropriate validated in vitro test.
A.2.3.6 In some cases sufficient information may be available
from structurally related substances to make classification
decisions.
A.2.3.7 The tiered approach explains how to organize existing
information on a substance and to make a weight of evidence decision
about hazard assessment and hazard classification (ideally without
conducting new animal tests). Although information might be gained
from the evaluation of single parameters within a tier,
consideration should be given to the totality of existing
information and making an overall weight of evidence determination.
This is especially true when there is conflict in information
available on some parameters.
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A.2.4 Classification Criteria for Mixtures
A.2.4.1 Classification of Mixtures When Data Are Available for the
Complete Mixture
A.2.4.1.1 The mixture shall be classified using the criteria for
substances, taking into account the tiered approach to evaluate data
for this hazard class (as illustrated in Figure A.2.1).
A.2.4.1.2 When considering testing of the mixture, classifiers
must use a tiered approach as included in the criteria for
classification of substances for skin corrosion and irritation to
help ensure an accurate classification, as well as to avoid
unnecessary animal testing. In the absence of any other information,
a mixture is considered corrosive (Skin Category 1) if it has a pH
<=2 or a pH >=11.5. However, if consideration of acid/alkaline
reserve suggests the mixture may not be corrosive despite the low or
high pH value, then further evaluation may be necessary.
A.2.4.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.2.4.2.1 Where the mixture itself has not been tested to
determine its skin corrosion/irritation potential, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data will be used in accordance with the following
bridging principles, as found in paragraph A.0.5 of this appendix:
Dilution, Batching, Concentration of mixtures, Interpolation within
one hazard category, Substantially similar mixtures, and Aerosols.
A.2.4.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.2.4.3.1 In order to make use of all available data for
purposes of classifying the skin corrosion/irritation hazards of
mixtures, the following assumption has been made and is applied
where appropriate in the tiered approach:
The ``relevant ingredients'' of a mixture are those which are
present in concentrations >=1% (weight/weight for solids, liquids,
dusts, mists and vapors and volume/volume for gases). If the
classifier has reason to suspect that an ingredient present at a
concentration <1% will affect classification of the mixture for skin
corrosion/irritation, that ingredient shall also be considered
relevant.
A.2.4.3.2 In general, the approach to classification of mixtures
as corrosive or irritant to the skin when data are available on the
ingredients, but not on the mixture as a whole, is based on the
theory of additivity, such that each corrosive or irritant
ingredient contributes to the overall corrosive or irritant
properties of the mixture in proportion to its potency and
concentration. A weighting factor of 10 is used for corrosive
ingredients when they are present at a concentration below the
concentration limit for classification with Category 1, but are at a
concentration that will contribute to the classification of the
mixture as an irritant. The mixture is classified as corrosive or
irritant when the sum of the concentrations of such ingredients
exceeds a cut-off value/concentration limit.
A.2.4.3.3 Table A.2.3 below provides the cut-off value/
concentration limits to be used to determine if the mixture is
considered to be corrosive or irritant to the skin.
A.2.4.3.4 Particular care shall be taken when classifying
certain types of chemicals such as acids and bases, inorganic salts,
aldehydes, phenols, and surfactants. The approach explained in
A.2.4.3.1 and A.2.4.3.2 might not work given that many of such
substances are corrosive or irritant at concentrations <1%. For
mixtures containing strong acids or bases the pH should be used as
classification criteria since pH will be a better indicator of
corrosion than the concentration limits in Table A.2.3. A mixture
containing corrosive or irritant ingredients that cannot be
classified based on the additivity approach shown in Table A.2.3,
due to chemical characteristics that make this approach unworkable,
should be classified as skin corrosion Category 1 if it contains
>=1% of a corrosive ingredient and as skin irritation Category 2
when it contains >=3% of an irritant ingredient. Classification of
mixtures with ingredients for which the approach in Table A.2.3 does
not apply is summarized in Table A.2.4 below.
A.2.4.3.5 On occasion, reliable data may show that the skin
corrosion/irritation of an ingredient will not be evident when
present at a level above the generic cut-off values/concentration
limits mentioned in Tables A.2.3 and A.2.4. In these cases the
mixture could be classified according to those data (See Use of cut-
off values/concentration limits, paragraph A.0.4.3 of this
appendix).
A.2.4.3.6 If there are data showing that (an) ingredient(s) may
be corrosive or irritant to skin at a concentration of <1%
(corrosive) or <3% (irritant), the mixture shall be classified
accordingly (See Use of cut-off values/concentration limits,
paragraph A.0.4.3 of this appendix).
Table A.2.3--Concentration of Ingredients of a Mixture Classified as Skin Category 1 or 2 That Would Trigger
Classification of the Mixture as Hazardous to Skin
[Category 1 or 2]
----------------------------------------------------------------------------------------------------------------
Concentration triggering classification of a mixture
as:
------------------------------------------------------
Sum of ingredients classified as: Skin corrosive Skin irritant
------------------------------------------------------
Category 1 Category 2
----------------------------------------------------------------------------------------------------------------
Skin Category 1.......................................... >=5% >=1% but <5%
Skin Category 2.......................................... ................ >=10%
(10 x Skin Category 1) + Skin Category 2................. ................ >=10%
----------------------------------------------------------------------------------------------------------------
Note: Where data are available and the sub-categories of skin Category 1 (corrosive) are used, the sum of all
ingredients of a mixture classified as sub-category 1A, 1B or 1C respectively, must each be >=5% in order to
classify the mixture as either skin sub-category 1A, 1B or 1C. Where the sum of 1A ingredients is <5% but the
sum of 1A + 1B ingredients is >=5%, the mixturemust be classified as sub-category 1B. Similarly, where the sum
of 1A + 1B ingredients is <5% but the sum of 1A + 1B + 1C ingredients is >=5% the mixture must be classified
as sub-category 1C. Where at least one relevant ingredient in a mixture is classified as Category 1 without
sub-categorization, the mixture must be classified as Category 1 without sub-categorization if the sum of all
ingredients corrosive to skin is >=5%.
Table A.2.4--Concentration of Ingredients of a Mixture When the
Additivity Approach Does Not Apply, That Would Trigger Classification of
the Mixture as Hazardous to Skin
------------------------------------------------------------------------
Mixture classified
Ingredient: Concentration: as: Skin
------------------------------------------------------------------------
Acid with pH <=2................. >=1% Category 1.
Base with pH >=11.5.............. >=1% Category 1.
Other corrosive (Category 1) >=1% Category 1.
ingredient.
Other irritant (Category 2) >=3% Category 2.
ingredient, including acids and
bases.
------------------------------------------------------------------------
[[Page 9736]]
A.3 Serious Eye Damage/Eye Irritation
A.3.1 Definitions and General Considerations
A.3.1.1 Serious eye damage refers to the production of tissue
damage in the eye, or serious physical decay of vision, which is not
fully reversible, occurring after exposure of the eye to a substance
or mixture.
Eye irritation refers to the production of changes in the eye,
which are fully reversible, occurring after exposure of the eye to a
substance or mixture.
A.3.1.2 Serious eye damage/eye irritation shall be classified
using a tiered approach as detailed in Figure A.3.1. Emphasis shall
be placed upon existing human data (See A.0.2.6), followed by
existing animal data, followed by in vitro data and then other
sources of information. Classification results directly when the
data satisfy the criteria in this section. In case the criteria
cannot be directly applied, classification of a substance or a
mixture is made on the basis of the total weight of evidence (See
A.0.3.1). This means that all available information bearing on the
determination of serious eye damage/eye irritation is considered
together, including the results of appropriate scientifically
validated in vitro tests, relevant animal data, and human data such
as epidemiological and clinical studies and well-documented case
reports and observations.
A.3.2 Classification Criteria for Substances
Substances are allocated to one of the categories within this
hazard class, Category 1 (serious eye damage) or Category 2 (eye
irritation), as follows:
(a) Category 1 (serious eye damage/irreversible effects on the
eye): Substances that have the potential to seriously damage the
eyes (see Table A.3.1).
(b) Category 2 (eye irritation/reversible effects on the eye):
Substances that have the potential to induce reversible eye
irritation (see Table A.3.2).
A.3.2.1 Classification based on standard animal test data.
A.3.2.1.1 Serious eye damage (Category 1)/Irreversible effects
on the eye.
A single hazard category is provided in Table A.3.1, for
substances that have the potential to seriously damage the eyes.
Category 1, irreversible effects on the eye, includes the criteria
listed below. These observations include animals with grade 4 cornea
lesions and other severe reactions (e.g., destruction of cornea)
observed at any time during the test, as well as persistent corneal
opacity, discoloration of the cornea by a dye substance, adhesion,
pannus, and interference with the function of the iris or other
effects that impair sight. In this context, persistent lesions are
considered those which are not fully reversible within an
observation period of normally 21 days. Category 1 also contains
substances fulfilling the criteria of corneal opacity >=3 and/or
iritis >1.5 observed in at least 2 of 3 tested animals detected in a
Draize eye test with rabbits, because severe lesions like these
usually do not reverse within a 21-day observation period.
Table A.3.1--Serious Eye Damage/Irreversible Effects on the Eye Category
a
------------------------------------------------------------------------
Criteria
------------------------------------------------------------------------
Category 1: Serious eye damage/ A substance that produces:
Irreversible effects on the eye. (a) In at least one animal
effects on the cornea, iris
or conjunctiva that are not
expected to reverse or have
not fully reversed within an
observation period of
normally 21 days; and/or
(b) in at least 2 of 3 tested
animals, a positive response
of:
(i) Corneal opacity >=3;
and/or
(ii) iritis >1.5;
calculated as the mean scores
following grading at 24, 48
and 72 hours after
instillation of the test
material.
------------------------------------------------------------------------
\a\ Grading criteria are understood as described in OECD Test Guideline
405.
A.3.2.2 Eye irritation (Category 2)/Reversible effects on the
eye.
A.3.2.2.1 A single Category 2 is provided in Table A.3.2 for
substances that have the potential to induce reversible eye
irritation.
When data are available, substances may be classified into
Category 2A and Category 2B:
(a) For substances inducing eye irritant effects reversing
within an observation time of normally 21 days, Category 2A applies.
(b) For substances inducing eye irritant effects reversing
within an observation time of 7 days, Category 2B applies.
When a substance is classified as Category 2, without further
categorization, the classification criteria are the same as those
for 2A.
A.3.2.3 For those substances where there is pronounced
variability among animal responses, this information may be taken
into account in determining the classification.
Table A.3.2--Reversible Effects on the Eye Categories a
------------------------------------------------------------------------
Criteria
------------------------------------------------------------------------
Substances that have the potential to
induce reversible eye irritation.
Category 2/2A................. Substances that produce in at least 2 of
3 tested animals a positive response
of:
(a) corneal opacity >=1; and/or
(b) iritis >=1; and/or
(c) conjunctival redness >=2; and/or
(d) conjunctival edema (chemosis) >=2
calculated as the mean scores following
grading at 24, 48 and 72 hours after
instillation of the test material, and
which fully reverses within an
observation period of normally 21 days.
Category 2B................... Within Category 2A an eye irritant is
considered mildly irritating to eyes
(Category 2B) when the effects listed
above are fully reversible within 7
days of observation.
------------------------------------------------------------------------
\a\ Grading criteria are understood as described in OECD Test Guideline
405.
A.3.3 Classification in a Tiered Approach
A.3.3.1 A tiered approach to the evaluation of initial
information shall be used where applicable, recognizing that all
elements may not be relevant in certain cases (Figure A.3.1).
A.3.3.2 Existing human and animal data should be the first line
of analysis, as they give information directly relevant to effects
on the eye. Possible skin corrosion shall be evaluated prior to
consideration of any testing for serious eye damage/eye irritation
in order to avoid testing for local effects on eyes with skin
corrosive substances.
A.3.3.3 In vitro alternatives that have been scientifically
validated and accepted shall be used to make classification
decisions.
A.3.3.4 Likewise, pH extremes like <=2 and >=11.5, may indicate
serious eye damage, especially when associated with significant
acid/alkaline reserve (buffering capacity). Generally, such
substances are expected to produce significant effects on the eyes.
In the absence of any other information, a substance is considered
to cause serious eye damage (Category 1) if it has a pH <=2 or
>=11.5.
[[Page 9737]]
However, if consideration of acid/alkaline reserve suggests the
substance may not cause serious eye damage despite the low or high
pH value, this needs needs to be confirmed by other data, preferably
by data from an appropriate validated in vitro test.
A.3.3.5 In some cases sufficient information may be available
from structurally related substances to make classification
decisions.
A.3.3.6 The tiered approach explains how to organize existing
information and to make a weight-of-evidence decision about hazard
assessment and hazard classification (ideally without conducting new
animal tests). Animal testing with corrosive substances should be
avoided wherever possible. Although information might be gained from
the evaluation of single parameters within a tier, consideration
should be given to the totality of existing information and making
an overall weight of evidence determination. This is especially true
when there is conflict in information available on some parameters.
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A.3.4 Classification Criteria for Mixtures
A.3.4.1 Classification of Mixtures When Data Are Available for the
Complete Mixture
A.3.4.1.1 The mixture will be classified using the criteria for
substances, and taking into account the tiered approach to evaluate
data for this hazard class (as illustrated in Figure A.3.1).
A.3.4.1.2 When considering testing of the mixture, chemical
manufacturers shall use a tiered approach as included in the
criteria for classification of substances for skin corrosion and
serious eye damage and eye irritation to help ensure an accurate
classification, as well as to avoid unnecessary animal testing. In
the absence of any other information, a mixture is considered to
cause serious eye damage (Category 1) if it has a pH <=2 or >=11.5.
However, if consideration of acid/alkaline reserve suggests the
mixture may not have the potential to cause serious eye damage
despite the low or high pH value, then further evaluation may be
necessary.
A.3.4.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.3.4.2.1 Where the mixture itself has not been tested to
determine its skin corrosivity or potential to cause serious eye
damage or eye irritation, but there are sufficient data on both the
individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data will be used in
accordance with the following bridging principles, as found in
paragraph A.0.5 of this appendix: Dilution, Batching, Concentration
of mixtures, Interpolation within one hazard category, Substantially
similar mixtures, and Aerosols.
A.3.4.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.3.4.3.1 For purposes of classifying the serious eye damage/eye
irritation hazards of mixtures in the tiered approach:
The ``relevant ingredients'' of a mixture are those which are
present in concentrations >=1% (weight/weight for solids, liquids,
dusts, mists and vapors and volume/volume for gases). If the
classifier has reason to suspect that an ingredient present at a
concentration <1% will affect classification of the mixture for
serious eye damage/eye irritation, that ingredient shall also be
considered relevant.
A.3.4.3.2 In general, the approach to classification of mixtures
as seriously damaging to the eye or eye irritant when data are
available on the ingredients, but not on the mixture as a whole, is
based on the theory of additivity, such that each skin corrosive or
serious eye damage/eye irritant ingredient contributes to the
overall serious eye damage/eye irritation properties of the mixture
in proportion to its potency and concentration. A weighting factor
of 10 is used for skin corrosive and serious eye damaging
ingredients when they are present at a concentration below the
concentration limit for classification with Category 1, but are at a
concentration that will contribute to the classification of the
mixture as serious eye damaging/eye irritant. The mixture is
classified as seriously damaging to the eye or eye irritant when the
sum of the concentrations of such ingredients exceeds a threshold
cut-off value/concentration limit.
A.3.4.3.3 Table A.3.3 provides the cut-off value/concentration
limits to be used to determine if the mixture must be classified as
seriously damaging to the eye or an eye irritant.
A.3.4.3.4 Particular care must be taken when classifying certain
types of chemicals such as acids and bases, inorganic salts,
aldehydes, phenols, and surfactants. The approach explained in
A.3.4.3.1 and A.3.4.3.2 might not work given that many of such
substances are seriously damaging to the eye/eye irritating at
concentrations <1%. For mixtures containing strong acids or bases,
the pH should be used as classification criteria (See A.3.4.1) since
pH will be a better indicator of serious eye damage (subject to
consideration of acid/alkali reserve) than the concentration limits
of Table A.3.3. A mixture containing skin corrosive or serious eye
damaging/eye irritating ingredients that cannot be classified based
on the additivity approach applied in Table A.3.3 due to chemical
characteristics that make this approach unworkable, should be
classified as serious eye damage (Category 1) if it contains >=1% of
a skin corrosive or serious eye damaging ingredient and as Eye
Irritation (Category 2) when it contains >=3% of an eye irritant
ingredient. Classification of mixtures with ingredients for which
the approach in Table A.3.3 does not apply is summarized in Table
A.3.4.
A.3.4.3.5 On occasion, reliable data may show that the
irreversible/reversible eye effects of an ingredient will not be
evident when present at a level above the generic cut-off values/
concentration limits mentioned in Tables A.3.3 and A.3.4. In these
cases the mixture could be classified according to those data (See
also A.0.4.3 Use of cut-off values/concentration limits''). On
occasion, when it is expected that the skin corrosion/irritation or
the reversible/irreversible eye effects of an ingredient will not be
evident when present at a level above the generic concentration/cut-
off levels mentioned in Tables A.3.3 and A.3.4, testing of the
mixture may be considered. In those cases, the tiered weight of
evidence approach should be applied as referred to in section A.3.3,
Figure A.3.1 and explained in detail in this chapter.
A.3.4.3.6 If there are data showing that (an) ingredient(s) may
be corrosive to the skin or seriously damaging to the eye/eye
irritating at a concentration of <1% (corrosive to the skin or
seriously damaging to the eye) or <3% (eye irritant), the mixture
shall be classified accordingly (See also paragraph A.0.4.3, Use of
cut-off values/concentration limits).
[[Page 9741]]
Table A.3.3--Concentration of Ingredients of a Mixture Classified as
Skin Category 1 and/or Eye Category 1 or 2 That Would Trigger
Classification of the Mixtures as Hazardous to the Eye
------------------------------------------------------------------------
Concentration triggering classification
of a mixture as
Sum of ingredients classified -----------------------------------------
as Serious eye damage Eye irritation
-----------------------------------------
Category 1 Category 2/2A
------------------------------------------------------------------------
Skin corrosion (Category 1) + >=3% >=1% but <3%.
Serious eye damage (Category
1) \a\.
Eye irritation (Category 2)... ..................... \b\ >=10%.
10 x (Skin corrosion (Category ..................... >=10%.
1) + Serious eye damage
(Category 1)) \a\ + Eye
irritation (Category 2).
------------------------------------------------------------------------
Notes:
\a\ If an ingredient is classified as both skin Category 1 and eye
Category 1 its concentration is considered only once in the
calculation.
\b\ A mixture may be classified as Eye Irritation Category 2B in cases
when all relevant ingredients are classified as Eye Irritation
Category 2B.
Table A.3.4--Concentration of Ingredients of a Mixture for Which the
Additivity Approach Does Not Apply, That Would Trigger Classification of
the Mixture as Hazardous to the Eye
------------------------------------------------------------------------
Concentration Mixture classified as:
Ingredient (%)
------------------------------------------------------------------------
Acid with pH <=2............... >=1 Serious eye damage
(Category 1).
Base with pH >=11.5............ >=1 Serious eye damage
(Category 1).
Other skin corrosive or serious >=1 Serious eye damage
eye damage (Category 1) (Category 1).
ingredients.
Other eye irritant (Category 2) >=3 Eye irritation
ingredients. (Category 2).
------------------------------------------------------------------------
A.4 Respiratory or Skin Sensitization
A.4.1 Definitions and General Considerations
A.4.1.1 Respiratory sensitization refers to hypersensitivity of
the airways occurring after inhalation of a substance or mixture.
Skin sensitization refers to an allergic response occurring
after skin contact with a substance or mixture.
A.4.1.2 For the purpose of this chapter, sensitization includes
two phases: The first phase is induction of specialized
immunological memory in an individual by exposure to an allergen.
The second phase is elicitation, i.e., production of a cell-mediated
or antibody-mediated allergic response by exposure of a sensitized
individual to an allergen.
A.4.1.3 For respiratory sensitization, the pattern of induction
followed by elicitation phases is shared in common with skin
sensitization. For skin sensitization, an induction phase is
required in which the immune system learns to react; clinical
symptoms can then arise when subsequent exposure is sufficient to
elicit a visible skin reaction (elicitation phase). As a
consequence, predictive tests usually follow this pattern in which
there is an induction phase, the response to which is measured by a
standardized elicitation phase, typically involving a patch test.
The local lymph node assay is the exception, directly measuring the
induction response. Evidence of skin sensitization in humans
normally is assessed by a diagnostic patch test.
A.4.1.4 Usually, for both skin and respiratory sensitization,
lower levels are necessary for elicitation than are required for
induction.
A.4.1.5 The hazard class ``respiratory or skin sensitization''
is differentiated into:
(a) Respiratory sensitization; and
(b) Skin sensitization.
A.4.2 Classification Criteria for Substances
A.4.2.1 Respiratory Sensitizers
A.4.2.1.1 Hazard categories
A.4.2.1.1.1 Effects seen in either humans or animals will
normally justify classification in a weight of evidence approach for
respiratory sensitizers. Substances may be allocated to one of the
two sub-categories 1A or 1B using a weight of evidence approach in
accordance with the criteria given in Table A.4.1 and on the basis
of reliable and good quality evidence from human cases or
epidemiological studies and/or observations from appropriate studies
in experimental animals.
A.4.2.1.1.2 Where data are not sufficient for sub-
categorization, respiratory sensitizers shall be classified in
Category 1.
---------------------------------------------------------------------------
\1\ At this writing, recognized and validated animal models for
the testing of respiratory hypersensitivity are not available. Under
certain circumstances, data from animal studies may provide valuable
information in a weight of evidence assessment.
Table A.4.1--Hazard Category and Sub-Categories for Respiratory
Sensitizers
------------------------------------------------------------------------
Category 1: Respiratory sensitizer
------------------------------------------------------------------------
A substance is classified as a
respiratory sensitizer:
(a) If there is evidence in humans that
the substance can lead to specific
respiratory hypersensitivity and/or
(b) if there are positive results from
an appropriate animal test.\1\
Sub-category 1A:.............. Substances showing a high frequency of
occurrence in humans; or a probability
of occurrence of a high sensitization
rate in humans based on animal or other
tests.1 Severity of reaction may also
be considered.
Sub-category 1B:.............. Substances showing a low to moderate
frequency of occurrence in humans; or a
probability of occurrence of a low to
moderate sensitization rate in humans
based on animal or other tests.\1\
Severity of reaction may also be
considered.
------------------------------------------------------------------------
A.4.2.1.2 Human evidence
A.4.2.1.2.1 Evidence that a substance can lead to specific
respiratory hypersensitivity will normally be based on human
experience. In this context, hypersensitivity is normally seen as
asthma, but other hypersensitivity reactions such as rhinitis/
conjunctivitis and alveolitis are also considered. The condition
will have the clinical character of an allergic reaction. However,
immunological mechanisms do not have to be demonstrated.
[[Page 9742]]
A.4.2.1.2.2 When considering the human evidence, it is necessary
that in addition to the evidence from the cases, the following be
taken into account:
(a) The size of the population exposed;
(b) The extent of exposure.
A.4.2.1.2.3 The evidence referred to above could be:
(a) Clinical history and data from appropriate lung function
tests related to exposure to the substance, confirmed by other
supportive evidence which may include:
(i) In vivo immunological test (e.g., skin prick test);
(ii) In vitro immunological test (e.g., serological analysis);
(iii) Studies that may indicate other specific hypersensitivity
reactions where immunological mechanisms of action have not been
proven, e.g., repeated low-level irritation, pharmacologically
mediated effects;
(iv) A chemical structure related to substances known to cause
respiratory hypersensitivity;
(b) Data from positive bronchial challenge tests with the
substance conducted according to accepted guidelines for the
determination of a specific hypersensitivity reaction.
A.4.2.1.2.4 Clinical history should include both medical and
occupational history to determine a relationship between exposure to
a specific substance and development of respiratory
hypersensitivity. Relevant information includes aggravating factors
both in the home and workplace, the onset and progress of the
disease, family history and medical history of the patient in
question. The medical history should also include a note of other
allergic or airway disorders from childhood and smoking history.
A.4.2.1.2.5 The results of positive bronchial challenge tests
are considered to provide sufficient evidence for classification on
their own. It is, however, recognized that in practice many of the
examinations listed above will already have been carried out.
A.4.2.1.3 Animal studies
A.4.2.1.3.1 Data from appropriate animal studies \2\ which may
be indicative of the potential of a substance to cause sensitization
by inhalation in humans \3\ may include:
---------------------------------------------------------------------------
\2\ At this writing, recognized and validated animal models for
the testing of respiratory hypersensitivity are not available. Under
certain circumstances, data from animal studies may provide valuable
information in a weight of evidence assessment.
\3\ The mechanisms by which substances induce symptoms of asthma
are not yet fully known. For preventive measures, these substances
are considered respiratory sensitizers. However, if on the basis of
the evidence, it can be demonstrated that these substances induce
symptoms of asthma by irritation only in people with bronchial
hyperactivity, they should not be considered as respiratory
sensitizers.
---------------------------------------------------------------------------
(a) Measurements of Immunoglobulin E (IgE) and other specific
immunological parameters, for example in mice.
(b) Specific pulmonary responses in guinea pigs.
A.4.2.2 Skin Sensitizers
A.4.2.2.1 Hazard categories
A.4.2.2.1.1 Effects seen in either humans or animals will
normally justify classification in a weight of evidence approach for
skin sensitizers. Substances may be allocated to one of the two sub-
categories 1A or 1B using a weight of evidence approach in
accordance with the criteria given in Table A.4.2 and on the basis
of reliable and good quality evidence from human cases or
epidemiological studies and/or observations from appropriate studies
in experimental animals according to the guidance values provided in
A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 1A and in A.4.2.2.2.2
and A.4.2.2.3.3 for sub-category 1B.
A.4.2.2.1.2 Where data are not sufficient for sub-
categorization, skin sensitizers shall be classified in Category 1.
Table A.4.2--Hazard Category and Sub-Categories for Skin Sensitizers
------------------------------------------------------------------------
Category 1: Skin sensitizer
------------------------------------------------------------------------
A substance is classified as a skin
sensitizer:
(a) If there is evidence in humans that
the substance can lead to sensitization
by skin contact in a substantial number
of persons, or
(b) if there are positive results from
an appropriate animal test.
Sub-category 1A:.............. Substances showing a high frequency of
occurrence in humans and/or a high
potency in animals can be presumed to
have the potential to produce
significant sensitization in humans.
Severity of reaction may also be
considered.
Sub-category 1B:.............. Substances showing a low to moderate
frequency of occurrence in humans and/
or a low to moderate potency in animals
can be presumed to have the potential
to produce sensitization in humans.
Severity of reaction may also be
considered.
------------------------------------------------------------------------
A.4.2.2.2 Human evidence
A.4.2.2.2.1 Human evidence for sub-category 1A may include:
(a) Positive responses at <=500 [micro]g/cm2 (Human Repeat
Insult Patch Test (HRIPT), Human Maximization Test (HMT)--induction
threshold);
(b) Diagnostic patch test data where there is a relatively high
and substantial incidence of reactions in a defined population in
relation to relatively low exposure;
(c) Other epidemiological evidence where there is a relatively
high and substantial incidence of allergic contact dermatitis in
relation to relatively low exposure.
A.4.2.2.2.2 Human evidence for sub-category 1B may include:
(a) Positive responses at >500 [micro]g/cm2 (HRIPT,
HMT--induction threshold);
(b) Diagnostic patch test data where there is a relatively low
but substantial incidence of reactions in a defined population in
relation to relatively high exposure;
(c) Other epidemiological evidence where there is a relatively
low but substantial incidence of allergic contact dermatitis in
relation to relatively high exposure.
A.4.2.2.3 Animal studies
A.4.2.2.3.1 For Category 1, when an adjuvant type test method
for skin sensitization is used, a response of at least 30% of the
animals is considered as positive. For a non-adjuvant Guinea pig
test method a response of at least 15% of the animals is considered
positive. For Category 1, a stimulation index of three or more is
considered a positive response in the local lymph node assay.\4\
---------------------------------------------------------------------------
\4\ Test methods for skin sensitization are described in OECD
Guideline 406 (the Guinea Pig Maximization test and the Buehler
guinea pig test) and Guideline 429 (Local Lymph Node Assay). Other
methods may be used provided that they are scientifically validated.
The Mouse Ear Swelling Test (MEST), appears to be a reliable
screening test to detect moderate to strong sensitizers, and can be
used, in accordance with professional judgment, as a first stage in
the assessment of skin sensitization potential.
---------------------------------------------------------------------------
A.4.2.2.3.2 Animal test results for sub-category 1A can include
data with values indicated in Table A.4.3 below:
Table A.4.3--Animal Test Results for Sub-Category 1A
------------------------------------------------------------------------
Assay Criteria
------------------------------------------------------------------------
Local lymph node assay........ EC3 value <=2%.
Guinea pig maximization test.. >=30% responding at <=0.1% intradermal
induction dose or >=60% responding at
>0.1% to <=1% intradermal induction
dose.
[[Page 9743]]
Buehler assay................. >=15% responding at <=0.2% topical
induction dose or >=60% responding at
>0.2% to <=20% topical induction dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
required to induce a stimulation index of 3 in the local lymph node
assay.
A.4.2.2.3.3 Animal test results for sub-category 1B can include
data with values indicated in the following Table A.4.4:
Table A.4.4--Animal Test Results for Sub-Category 1B
------------------------------------------------------------------------
Assay Criteria
------------------------------------------------------------------------
Local lymph node assay........ EC3 value >2%.
Guinea pig maximization test.. >=30% to <60% responding at >0.1% to
<=1% intradermal induction dose or
>=30% responding at >1% intradermal
induction dose.
Buehler assay................. >=15% to <60% responding at >0.2% to
<=20% topical induction dose or >=15%
responding at >20% topical induction
dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
required to induce a stimulation index of 3 in the local lymph node
assay.
A.4.2.2.4 Specific considerations
A.4.2.2.4.1 For classification of a substance, evidence shall
include one or more of the following using a weight of evidence
approach:
(a) Positive data from patch testing, normally obtained in more
than one dermatology clinic;
(b) Epidemiological studies showing allergic contact dermatitis
caused by the substance. Situations in which a high proportion of
those exposed exhibit characteristic symptoms are to be looked at
with special concern, even if the number of cases is small;
(c) Positive data from appropriate animal studies;
(d) Positive data from experimental studies in humans (See
paragraph A.0.2.6 of this appendix);
(e) Well documented episodes of allergic contact dermatitis,
normally obtained in more than one dermatology clinic;
(f) Severity of reaction.
A.4.2.2.4.2 Evidence from animal studies is usually much more
reliable than evidence from human exposure. However, in cases where
evidence is available from both sources, and there is conflict
between the results, the quality and reliability of the evidence
from both sources must be assessed in order to resolve the question
of classification on a case-by-case basis. Normally, human data are
not generated in controlled experiments with volunteers for the
purpose of hazard classification but rather as part of risk
assessment to confirm lack of effects seen in animal tests.
Consequently, positive human data on skin sensitization are usually
derived from case-control or other, less defined studies. Evaluation
of human data must, therefore, be carried out with caution as the
frequency of cases reflect, in addition to the inherent properties
of the substances, factors such as the exposure situation,
bioavailability, individual predisposition and preventive measures
taken. Negative human data should not normally be used to negate
positive results from animal studies. For both animal and human
data, consideration should be given to the impact of vehicle.
A.4.2.2.4.3 If none of the above-mentioned conditions are met,
the substance need not be classified as a skin sensitizer. However,
a combination of two or more indicators of skin sensitization, as
listed below, may alter the decision. This shall be considered on a
case-by-case basis.
(a) Isolated episodes of allergic contact dermatitis;
(b) Epidemiological studies of limited power, e.g., where
chance, bias or confounders have not been ruled out fully with
reasonable confidence;
(c) Data from animal tests, performed according to existing
guidelines, which do not meet the criteria for a positive result
described in A.4.2.2.3, but which are sufficiently close to the
limit to be considered significant;
(d) Positive data from non-standard methods;
(e) Positive results from close structural analogues.
A.4.2.2.4.4 Immunological contact urticaria
A.4.2.2.4.4.1 Substances meeting the criteria for classification
as respiratory sensitizers may, in addition, cause immunological
contact urticaria. Consideration shall be given to classifying these
substances as skin sensitizers.
A.4.2.2.4.4.2 Substances which cause immunological contact
urticaria without meeting the criteria for respiratory sensitizers
shall be considered for classification as skin sensitizers.
A.4.2.2.4.4.3 There is no recognized animal model available to
identify substances which cause immunological contact urticaria.
Therefore, classification will normally be based on human evidence,
similar to that for skin sensitization.
A.4.3 Classification Criteria for Mixtures
A.4.3.1 Classification of Mixtures When Data Are Available for the
Complete Mixture
When reliable and good quality evidence, as described in the
criteria for substances, from human experience or appropriate
studies in experimental animals, is available for the mixture, then
the mixture shall be classified by weight of evidence evaluation of
these data. Care must be exercised in evaluating data on mixtures
that the dose used does not render the results inconclusive.
A.4.3.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.4.3.2.1 Where the mixture itself has not been tested to
determine its sensitizing properties, but there are sufficient data
on both the individual ingredients and similar tested mixtures to
adequately characterize the hazards of the mixture, these data will
be used in accordance with the following agreed bridging principles
as found in paragraph A.0.5 of this appendix: Dilution, Batching,
Concentration of mixtures, Interpolation within one hazard category/
subcategory, Substantially similar mixtures, and Aerosols.
A.4.3.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
The mixture shall be classified as a respiratory or skin
sensitizer when at least one ingredient has been classified as a
respiratory or skin sensitizer and is present at or above the
appropriate cut-off value/concentration limit for the specific
endpoint as shown in Table A.4.5.
[[Page 9744]]
Table A.4.5--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Either Respiratory
Sensitizers or Skin Sensitizers That Would Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
Cut-off values/concentration limits triggering
classification of a mixture as:
------------------------------------------------------
Respiratory sensitizer Skin sensitizer
Ingredient classified as: Category 1 Category 1
------------------------------------------------------
Solid/Liquid All physical states
(%) Gas (%)
----------------------------------------------------------------------------------------------------------------
Respiratory Sensitizer: Category 1....................... >=0.1 >=0.1 .....................
Respiratory Sensitizer: Sub-category 1A.................. >=0.1 >=0.1 .....................
Respiratory Sensitizer: Sub-category 1B.................. >=1.0 >=0.2 .....................
Skin Sensitizer: Category 1.............................. .............. .............. >=0.1
Skin Sensitizer: Sub-category 1A......................... .............. .............. >=0.1
Skin Sensitizer: Sub-category 1B......................... .............. .............. >=1.0
----------------------------------------------------------------------------------------------------------------
A.5 Germ Cell Mutagenicity
A.5.1 Definitions and General Considerations
A.5.1.1 Germ cell mutagenicity refers to heritable gene
mutations, including heritable structural and numerical chromosome
aberrations in germ cells occurring after exposure to a substance or
mixture.
A.5.1.2 A mutation is defined as a permanent change in the
amount or structure of the genetic material in a cell. The term
mutation applies both to heritable genetic changes that may be
manifested at the phenotypic level and to the underlying DNA
modifications when known (including, for example, specific base pair
changes and chromosomal translocations). The term mutagenic and
mutagen will be used for agents giving rise to an increased
occurrence of mutations in populations of cells and/or organisms.
A.5.1.3 The more general terms genotoxic and genotoxicity apply
to agents or processes which alter the structure, information
content, or segregation of DNA, including those which cause DNA
damage by interfering with normal replication processes, or which in
a non-physiological manner (temporarily) alter its replication.
Genotoxicity test results are usually taken as indicators for
mutagenic effects.
A.5.1.4 This hazard class is primarily concerned with chemicals
that may cause mutations in the germ cells of humans that can be
transmitted to the progeny. However, mutagenicity/genotoxicity tests
in vitro and in mammalian somatic cells in vivo are also considered
in classifying substances and mixtures within this hazard class.
A.5.2 Classification Criteria for Substances
A.5.2.1 The classification system provides for two different
categories of germ cell mutagens to accommodate the weight of
evidence available. The two-category system is described in the
Figure A.5.1.
Figure A.5.1--Hazard Categories for Germ Cell Mutagens
------------------------------------------------------------------------
-------------------------------------------------------------------------
CATEGORY 1: Substances known to induce heritable mutations or to be
regarded as if they induce heritable mutations in the germ cells of
humans.
Category 1A: Substances known to induce heritable mutations in germ
cells of humans. Positive evidence from human epidemiological
studies.
Category 1B: Substances which should be regarded as if they induce
heritable mutations in the germ cells of humans:
(a) Positive result(s) from in vivo heritable germ cell
mutagenicity tests in mammals; or
(b) Positive result(s) from in vivo somatic cell mutagenicity
tests in mammals, in combination with some evidence that the
substance has potential to cause mutations to germ cells. This
supporting evidence may, for example, be derived from
mutagenicity/genotoxicity tests in germ cells in vivo, or by
demonstrating the ability of the substance or its metabolite(s)
to interact with the genetic material of germ cells; or
(c) Positive results from tests showing mutagenic effects in the
germ cells of humans, without demonstration of transmission to
progeny; for example, an increase in the frequency of
aneuploidy in sperm cells of exposed people.
CATEGORY 2: Substances which cause concern for humans owing to the
possibility that they may induce heritable mutations in the germ cells
of humans.
Positive evidence obtained from experiments in mammals and/or in some
cases from in vitro experiments, obtained from:
(a) Somatic cell mutagenicity tests in vivo, in mammals; or
(b) Other in vivo somatic cell genotoxicity tests which are
supported by positive results from in vitro mutagenicity assays.
------------------------------------------------------------------------
Note: Substances which are positive in in vitro mammalian mutagenicity
assays, and which also show chemical structure activity relationship
to known germ cell mutagens, should be considered for classification
as Category 2 mutagens.
A.5.2.2 Specific considerations for classification of substances
as germ cell mutagens:
A.5.2.2.1 To arrive at a classification, test results are
considered from experiments determining mutagenic and/or genotoxic
effects in germ and/or somatic cells of exposed animals. Mutagenic
and/or genotoxic effects determined in in vitro tests shall also be
considered.
A.5.2.2.2 The system is hazard based, classifying chemicals on
the basis of their intrinsic ability to induce mutations in germ
cells. The scheme is, therefore, not meant for the (quantitative)
risk assessment of chemical substances.
A.5.2.2.3 Classification for heritable effects in human germ
cells is made on the basis of scientifically validated tests.
Evaluation of the test results shall be done using expert judgment
and all the available evidence shall be weighed for classification.
A.5.2.2.4 The classification of substances shall be based on the
total weight of evidence available, using expert judgment. In those
instances where a single well-conducted test is used for
classification, it shall provide clear and unambiguously positive
results. The relevance of the route of exposure used in the study of
the substance compared to the route of human exposure should also be
taken into account.
A.5.3 Classification Criteria for Mixtures 5
---------------------------------------------------------------------------
\5\ It should be noted that the classification criteria for
health hazards usually include a tiered scheme in which test data
available on the complete mixture are considered as the first tier
in the evaluation, followed by the applicable bridging principles,
and lastly, cut-off values/concentration limits or additivity.
However, this approach is not used for Germ Cell Mutagenicity. These
criteria for Germ Cell Mutagenicity consider the cut-off values/
concentration limits as the primary tier and allow the
classification to be modified only on a case-by-case evaluation
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------
A.5.3.1 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.5.3.1.1 Classification of mixtures shall be based on the
available test data for the
[[Page 9745]]
individual ingredients of the mixture using cut-off values/
concentration limits for the ingredients classified as germ cell
mutagens.
A.5.3.1.2 The mixture will be classified as a mutagen when at
least one ingredient has been classified as a Category 1A, Category
1B or Category 2 mutagen and is present at or above the appropriate
cut-off value/concentration limit as shown in Table A.5.1 below for
Category 1 and 2 respectively.
Table A.5.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Germ Cell Mutagens
That Would Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
Cut-off/concentration limits triggering
classification of a mixture as:
Ingredient classified as: ---------------------------------------------
Category 1 mutagen Category 2 mutagen
----------------------------------------------------------------------------------------------------------------
Category 1A/B mutagen............................................. >=0.1% .....................
Category 2 mutagen................................................ ..................... >=1.0%
----------------------------------------------------------------------------------------------------------------
Note: The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well
as gases (v/v units).
A.5.3.2 Classification of Mixtures When Data Are Available for the
Mixture Itself
The classification may be modified on a case-by-case basis based
on the available test data for the mixture as a whole. In such
cases, the test results for the mixture as a whole must be shown to
be conclusive taking into account dose and other factors such as
duration, observations and analysis (e.g., statistical analysis,
test sensitivity) of germ cell mutagenicity test systems.
A.5.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.5.3.3.1 Where the mixture itself has not been tested to
determine its germ cell mutagenicity hazard, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data will be used in accordance with the following
bridging principles as found in paragraph A.0.5 of this appendix:
Dilution, Batching, and Substantially similar mixtures.
A.5.4 Examples of Scientifically Validated Test Methods
A.5.4.1 Examples of in vivo heritable germ cell mutagenicity
tests are:
(a) Rodent dominant lethal mutation test (OECD 478)
(b) Mouse heritable translocation assay (OECD 485)
(c) Mouse specific locus test
A.5.4.2 Examples of in vivo somatic cell mutagenicity tests are:
(a) Mammalian bone marrow chromosome aberration test (OECD 475)
(b) Mammalian erythrocyte micronucleus test (OECD 474)
A.5.4.3 Examples of mutagenicity/genotoxicity tests in germ
cells are:
(a) Mutagenicity tests:
(i) Mammalian spermatogonial chromosome aberration test (OECD
483)
(ii) Spermatid micronucleus assay
(b) Genotoxicity tests:
(i) Sister chromatid exchange analysis in spermatogonia
(ii) Unscheduled DNA synthesis test (UDS) in testicular cells
A.5.4.4 Examples of genotoxicity tests in somatic cells are:
(a) Liver Unscheduled DNA Synthesis (UDS) in vivo (OECD 486)
(b) Mammalian bone marrow Sister Chromatid Exchanges (SCE)
A.5.4.5 Examples of in vitro mutagenicity tests are:
(a) In vitro mammalian chromosome aberration test (OECD 473)
(b) In vitro mammalian cell gene mutation test (OECD 476)
(c) Bacterial reverse mutation tests (OECD 471)
A.5.4.6 As new, scientifically validated tests arise, these may
also be used in the total weight of evidence to be considered.
A.6 Carcinogenicity
A.6.1 Definitions
Carcinogenicity refers to the induction of cancer or an increase
in the incidence of cancer occurring after exposure to a substance
or mixture. Substances and mixtures which have induced benign and
malignant tumors in well-performed experimental studies on animals
are considered also to be presumed or suspected human carcinogens
unless there is strong evidence that the mechanism of tumor
formation is not relevant for humans.
Classification of a substance or mixture as posing a
carcinogenic hazard is based on its inherent properties and does not
provide information on the level of the human cancer risk which the
use of the substance or mixture may represent.
A.6.2 Classification Criteria for Substances 6
---------------------------------------------------------------------------
\6\ See Non-mandatory appendix F of this section, part A for
further guidance regarding hazard classification for
carcinogenicity. This appendix is consistent with the GHS and is
provided as guidance excerpted from the International Agency for
Research on Cancer (IARC) ``Monographs on the Evaluation of
Carcinogenic Risks to Humans'' (2006).
---------------------------------------------------------------------------
A.6.2.1 For the purpose of classification for carcinogenicity,
substances are allocated to one of two categories based on strength
of evidence and additional weight of evidence considerations. In
certain instances, route-specific classification may be warranted.
Figure A.6.1--Hazard Categories for Carcinogens
------------------------------------------------------------------------
-------------------------------------------------------------------------
CATEGORY 1: Known or presumed human carcinogens. The classification of a
substance as a Category 1 carcinogen is done on the basis of
epidemiological and/or animal data. This classification is further
distinguished on the basis of whether the evidence for classification
is largely from human data (Category 1A) or from animal data (Category
1B):
Category 1A: Known to have carcinogenic potential for humans.
Classification in this category is largely based on human evidence.
Category 1B: Presumed to have carcinogenic potential for humans.
Classification in this category is largely based on animal
evidence. The classification of a substance in Category 1A and 1B
is based on strength of evidence together with weight of evidence
considerations (See paragraph A.6.2.5). Such evidence may be
derived from:
--human studies that establish a causal relationship between
human exposure to a substance and the development of cancer
(known human carcinogen); or
--animal experiments for which there is sufficient evidence to
demonstrate animal carcinogenicity (presumed human carcinogen).
In addition, on a case by case basis, scientific judgment may
warrant a decision of presumed human carcinogenicity derived from
studies showing limited evidence of carcinogenicity in humans
together with limited evidence of carcinogenicity in experimental
animals.
[[Page 9746]]
CATEGORY 2: Suspected human carcinogens. The classification of a
substance in Category 2 is done on the basis of evidence obtained from
human and/or animal studies, but which is not sufficiently convincing
to place the substance in Category 1A or B. This classification is
based on strength of evidence together with weight of evidence
considerations (See paragraph A.6.2.5). Such evidence may be from
either limited evidence of carcinogenicity in human studies or from
limited evidence of carcinogenicity in animal studies.
Other considerations: Where the weight of evidence for the
carcinogenicity of a substance does not meet the above criteria, any
positive study conducted in accordance with established scientific
principles, and which reports statistically significant findings
regarding the carcinogenic potential of the substance, must be noted on
the safety data sheet.
------------------------------------------------------------------------
A.6.2.2 Classification as a carcinogen is made on the basis of
evidence from reliable and acceptable methods, and is intended to be
used for substances which have an intrinsic property to produce such
toxic effects. The evaluations are to be based on all existing data,
peer-reviewed published studies and additional data accepted by
regulatory agencies.
A.6.2.3 Carcinogen classification is a one-step, criterion-based
process that involves two interrelated determinations: Evaluations
of strength of evidence and consideration of all other relevant
information to place substances with human cancer potential into
hazard categories.
A.6.2.4 Strength of evidence involves the enumeration of tumors
in human and animal studies and determination of their level of
statistical significance. Sufficient human evidence demonstrates
causality between human exposure and the development of cancer,
whereas sufficient evidence in animals shows a causal relationship
between the agent and an increased incidence of tumors. Limited
evidence in humans is demonstrated by a positive association between
exposure and cancer, but a causal relationship cannot be stated.
Limited evidence in animals is provided when data suggest a
carcinogenic effect, but are less than sufficient. (Guidance on
consideration of important factors in the classification of
carcinogenicity and a more detailed description of the terms
``limited'' and ``sufficient'' have been developed by the
International Agency for Research on Cancer (IARC) and are provided
in non-mandatory appendix F of this section.)
A.6.2.5 Weight of evidence: Beyond the determination of the
strength of evidence for carcinogenicity, a number of other factors
should be considered that influence the overall likelihood that an
agent may pose a carcinogenic hazard in humans. The full list of
factors that influence this determination is very lengthy, but some
of the important ones are considered here.
A.6.2.5.1 These factors can be viewed as either increasing or
decreasing the level of concern for human carcinogenicity. The
relative emphasis accorded to each factor depends upon the amount
and coherence of evidence bearing on each. Generally, there is a
requirement for more complete information to decrease than to
increase the level of concern. Additional considerations should be
used in evaluating the tumor findings and the other factors in a
case-by-case manner.
A.6.2.5.2 Some important factors which may be taken into
consideration, when assessing the overall level of concern are:
(a) Tumor type and background incidence;
(b) Multisite responses;
(c) Progression of lesions to malignancy;
(d) Reduced tumor latency;
Additional factors which may increase or decrease the level of
concern include:
(e) Whether responses are in single or both sexes;
(f) Whether responses are in a single species or several
species;
(g) Structural similarity or not to a substance(s) for which
there is good evidence of carcinogenicity;
(h) Routes of exposure;
(i) Comparison of absorption, distribution, metabolism and
excretion between test animals and humans;
(j) The possibility of a confounding effect of excessive
toxicity at test doses; and,
(k) Mode of action and its relevance for humans, such as
mutagenicity, cytotoxicity with growth stimulation, mitogenesis,
immunosuppression.
Mutagenicity: It is recognized that genetic events are central
in the overall process of cancer development. Therefore, evidence of
mutagenic activity in vivo may indicate that a substance has a
potential for carcinogenic effects.
A.6.2.5.3 A substance that has not been tested for
carcinogenicity may in certain instances be classified in Category
1A, Category 1B, or Category 2 based on tumor data from a structural
analogue together with substantial support from consideration of
other important factors such as formation of common significant
metabolites, e.g., for benzidine congener dyes.
A.6.2.5.4 The classification should also take into consideration
whether or not the substance is absorbed by a given route(s); or
whether there are only local tumors at the site of administration
for the tested route(s), and adequate testing by other major
route(s) show lack of carcinogenicity.
A.6.2.5.5 It is important that whatever is known of the physico-
chemical, toxicokinetic and toxicodynamic properties of the
substances, as well as any available relevant information on
chemical analogues, i.e., structure activity relationship, is taken
into consideration when undertaking classification.
A.6.3 Classification Criteria for Mixtures 7
---------------------------------------------------------------------------
\7\ It should be noted that the classification criteria for
health hazards usually include a tiered scheme in which test data
available on the complete mixture are considered as the first tier
in the evaluation, followed by the applicable bridging principles,
and lastly, cut-off values/concentration limit or additivity.
However, this approach is not used for Carcinogenicity. These
criteria for Carcinogenicity consider the cut-off values/
concentration limits as the primary tier and allow the
classification to be modified only on a case-by-case evaluation
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------
A.6.3.1 The mixture shall be classified as a carcinogen when at
least one ingredient has been classified as a Category 1 or Category
2 carcinogen and is present at or above the appropriate cut-off
value/concentration limit as shown in Table A.6.1.
Table A.6.1--Cut-Off Values/Concentration Limits of Ingredients of a
Mixture Classified as Carcinogen That Would Trigger Classification of
the Mixture
------------------------------------------------------------------------
Category 1 Category 2
Ingredient classified as: carcinogen carcinogen
------------------------------------------------------------------------
Category 1 carcinogen............. >=0.1% .................
Category 2 carcinogen............. ................. >=0.1% (note 1)
------------------------------------------------------------------------
Note: If a Category 2 carcinogen ingredient is present in the mixture at
a concentration between 0.1% and 1%, information is required on the
SDS for a product. However, a label warning is optional. If a Category
2 carcinogen ingredient is present in the mixture at a concentration
of =1%, both an SDS and a label is required and the
information must be included on each.
[[Page 9747]]
A.6.3.2 Classification of Mixtures When Data Are Available for the
Complete Mixture
A mixture may be classified based on the available test data for
the mixture as a whole. In such cases, the test results for the
mixture as a whole must be shown to be conclusive taking into
account dose and other factors such as duration, observations and
analysis (e.g., statistical analysis, test sensitivity) of
carcinogenicity test systems.
A.6.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
Where the mixture itself has not been tested to determine its
carcinogenic hazard, but there are sufficient data on both the
individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data will be used in
accordance with the following bridging principles as found in
paragraph A.0.5 of this appendix: Dilution; Batching; and
Substantially similar mixtures.
A.6.4 Classification of Carcinogenicity 8
---------------------------------------------------------------------------
\8\ See Non-mandatory appendix F of this section for further
guidance regarding hazard classification for carcinogenicity and how
to relate carcinogenicity classification information from IARC and
NTP to GHS.
---------------------------------------------------------------------------
A.6.4.1 Chemical manufacturers, importers and employers
evaluating chemicals may treat the following sources as establishing
that a substance is a carcinogen or potential carcinogen for hazard
communication purposes in lieu of applying the criteria described
herein:
A.6.4.1.1 National Toxicology Program (NTP), ``Report on
Carcinogens'' (latest edition);
A.6.4.1.2 International Agency for Research on Cancer (IARC)
``Monographs on the Evaluation of Carcinogenic Risks to Humans''
(latest editions)
A.6.4.2 Where OSHA has included cancer as a health hazard to be
considered by classifiers for a chemical covered by this section
subpart, chemical manufacturers, importers, and employers shall
classify the chemical as a carcinogen.
A.7 Reproductive Toxicity
A.7.1 Definitions and General Considerations
A.7.1.1 Reproductive toxicity refers to adverse effects on
sexual function and fertility in adult males and females, as well as
developmental toxicity in the offspring, occurring after exposure to
a substance or mixture. Some reproductive toxic effects cannot be
clearly assigned to either impairment of sexual function and
fertility or to developmental toxicity. Nonetheless, substances and
mixtures with these effects shall be classified as reproductive
toxicants.
For classification purposes, the known induction of genetically
based inheritable effects in the offspring is addressed in Germ cell
mutagenicity (See A.5).
A.7.1.2 Adverse effects on sexual function and fertility means
any effect of chemicals that interferes with reproductive ability or
sexual capacity. This includes, but is not limited to, alterations
to the female and male reproductive system, adverse effects on onset
of puberty, gamete production and transport, reproductive cycle
normality, sexual behaviour, fertility, parturition, pregnancy
outcomes, premature reproductive senescence, or modifications in
other functions that are dependent on the integrity of the
reproductive systems.
A.7.1.3 Adverse effects on development of the offspring means
any effect of chemicals which interferes with normal development of
the conceptus either before or after birth, which is induced during
pregnancy or results from parental exposure. These effects can be
manifested at any point in the life span of the organism. The major
manifestations of developmental toxicity include death of the
developing organism, structural abnormality, altered growth and
functional deficiency.
A.7.1.4 Adverse effects on or via lactation are also included in
reproductive toxicity, but for classification purposes, such effects
are treated separately (See A.7.2.1).
A.7.2 Classification Criteria for Substances
A.7.2.1 For the purpose of classification for reproductive
toxicity, substances shall be classified in one of two categories in
accordance with Figure A.7.1(a). Effects on sexual function and
fertility, and on development, shall be considered. In addition,
effects on or via lactation shall be classified in a separate hazard
category in accordance with Figure A.7.1(b).
Figure A.7.1(a)--Hazard Categories for Reproductive Toxicants
------------------------------------------------------------------------
-------------------------------------------------------------------------
CATEGORY 1: Known or presumed human reproductive toxicant. Substance
shall be classified in Category 1 for reproductive toxicity when they
are known to have produced an adverse effect on sexual function and
fertility or on development in humans or when there is evidence from
animal studies, possibly supplemented with other information, to
provide a strong presumption that the substance has the capacity to
interfere with reproduction in humans. The classification of a
substance is further distinguished on the basis of whether the evidence
for classification is primarily from human data (Category 1A) or from
animal data (Category 1B).
Category 1A: Known human reproductive toxicant. The classification
of a substance in this category is largely based on evidence from
humans.
Category 1B: Presumed human reproductive toxicant. The
classification of a substance in this category is largely based on
evidence from experimental animals. Data from animal studies shall
provide sufficient evidence of an adverse effect on sexual function
and fertility or on development in the absence of other toxic
effects, or if occurring together with other toxic effects the
adverse effect on reproduction is considered not to be a secondary
non-specific consequence of other toxic effects. However, when
there is mechanistic information that raises doubt about the
relevance of the effect for humans, classification in Category 2
may be more appropriate.
CATEGORY 2: Suspected human reproductive toxicant. Substances shall be
classified in Category 2 for reproductive toxicity when there is some
evidence from humans or experimental animals, possibly supplemented
with other information, of an adverse effect on sexual function and
fertility, or on development, in the absence of other toxic effects, or
if occurring together with other toxic effects the adverse effect on
reproduction is considered not to be a secondary non-specific
consequence of the other toxic effects, and where the evidence is not
sufficiently convincing to place the substance in Category 1. For
instance, deficiencies in the study may make the quality of evidence
less convincing, and in view of this, Category 2 would be the more
appropriate classification.
------------------------------------------------------------------------
Figure A.7.1(b)--Hazard Category for Effects on or Via Lactation
------------------------------------------------------------------------
-------------------------------------------------------------------------
Effects on or Via Lactation
Effects on or via lactation shall be classified in a separate single
category. Chemicals that are absorbed by women and have been shown to
interfere with lactation or that may be present (including metabolites)
in breast milk in amounts sufficient to cause concern for the health of
a breastfed child, shall be classified to indicate this property.
Classification for effects via lactation shall be assigned on the basis
of:
(a) Absorption, metabolism, distribution and excretion studies that
indicate the likelihood the substance would be present in
potentially toxic levels in breast milk; and/or
(b) results of one or two generation studies in animals which
provide clear evidence of adverse effect in the offspring due to
transfer in the milk or adverse effect on the quality of the milk;
and/or
(c) human evidence indicating a hazard to babies during the
lactation period.
------------------------------------------------------------------------
[[Page 9748]]
A.7.2.2 Basis of Classification
A.7.2.2.1 Classification is made on the basis of the criteria,
outlined above, an assessment of the total weight of evidence, and
the use of expert judgment. Classification as a reproductive
toxicant is intended to be used for substances which have an
intrinsic, specific property to produce an adverse effect on
reproduction and substances should not be so classified if such an
effect is produced solely as a non-specific secondary consequence of
other toxic effects.
A.7.2.2.2 In the evaluation of toxic effects on the developing
offspring, it is important to consider the possible influence of
maternal toxicity.
A.7.2.2.3 For human evidence to provide the primary basis for a
Category 1A classification there must be reliable evidence of an
adverse effect on reproduction in humans. Evidence used for
classification shall be from well conducted epidemiological studies,
if available, which include the use of appropriate controls,
balanced assessment, and due consideration of bias or confounding
factors. Less rigorous data from studies in humans may be sufficient
for a Category 1A classification if supplemented with adequate data
from studies in experimental animals, but classification in Category
1B may also be considered.
A.7.2.3 Weight of Evidence
A.7.2.3.1 Classification as a reproductive toxicant is made on
the basis of an assessment of the total weight of evidence using
expert judgment. This means that all available information that
bears on the determination of reproductive toxicity is considered
together. Included is information such as epidemiological studies
and case reports in humans and specific reproduction studies along
with sub-chronic, chronic and special study results in animals that
provide relevant information regarding toxicity to reproductive and
related endocrine organs. Evaluation of substances chemically
related to the material under study may also be included,
particularly when information on the material is scarce. The weight
given to the available evidence will be influenced by factors such
as the quality of the studies, consistency of results, nature and
severity of effects, level of statistical significance for
intergroup differences, number of endpoints affected, relevance of
route of administration to humans and freedom from bias. Both
positive and negative results are considered together in a weight of
evidence determination. However, a single, positive study performed
according to good scientific principles and with statistically or
biologically significant positive results may justify classification
(See also A.7.2.2.3).
A.7.2.3.2 Toxicokinetic studies in animals and humans, site of
action and mechanism or mode of action study results may provide
relevant information, which could reduce or increase concerns about
the hazard to human health. If it is conclusively demonstrated that
the clearly identified mechanism or mode of action has no relevance
for humans or when the toxicokinetic differences are so marked that
it is certain that the hazardous property will not be expressed in
humans then a chemical which produces an adverse effect on
reproduction in experimental animals should not be classified.
A.7.2.3.3 In some reproductive toxicity studies in experimental
animals the only effects recorded may be considered of low or
minimal toxicological significance and classification may not
necessarily be the outcome. These effects include, for example,
small changes in semen parameters or in the incidence of spontaneous
defects in the fetus, small changes in the proportions of common
fetal variants such as are observed in skeletal examinations, or in
fetal weights, or small differences in postnatal developmental
assessments.
A.7.2.3.4 Data from animal studies shall provide sufficient
evidence of specific reproductive toxicity in the absence of other
systemic toxic effects. However, if developmental toxicity occurs
together with other toxic effects in the dam (mother), the potential
influence of the generalized adverse effects should be assessed to
the extent possible. The preferred approach is to consider adverse
effects in the embryo/fetus first, and then evaluate maternal
toxicity, along with any other factors which are likely to have
influenced these effects, as part of the weight of evidence. In
general, developmental effects that are observed at maternally toxic
doses should not be automatically discounted. Discounting
developmental effects that are observed at maternally toxic doses
can only be done on a case-by-case basis when a causal relationship
is established or refuted.
A.7.2.3.5 If appropriate information is available it is
important to try to determine whether developmental toxicity is due
to a specific maternally mediated mechanism or to a non-specific
secondary mechanism, like maternal stress and the disruption of
homeostasis. Generally, the presence of maternal toxicity should not
be used to negate findings of embryo/fetal effects, unless it can be
clearly demonstrated that the effects are secondary non-specific
effects. This is especially the case when the effects in the
offspring are significant, e.g., irreversible effects such as
structural malformations. In some situations it is reasonable to
assume that reproductive toxicity is due to a secondary consequence
of maternal toxicity and discount the effects, for example if the
chemical is so toxic that dams fail to thrive and there is severe
inanition; they are incapable of nursing pups; or they are prostrate
or dying.
A.7.2.4 Maternal Toxicity
A.7.2.4.1 Development of the offspring throughout gestation and
during the early postnatal stages can be influenced by toxic effects
in the mother either through non-specific mechanisms related to
stress and the disruption of maternal homeostasis, or by specific
maternally-mediated mechanisms. So, in the interpretation of the
developmental outcome to decide classification for developmental
effects it is important to consider the possible influence of
maternal toxicity. This is a complex issue because of uncertainties
surrounding the relationship between maternal toxicity and
developmental outcome. Expert judgment and a weight of evidence
approach, using all available studies, shall be used to determine
the degree of influence to be attributed to maternal toxicity when
interpreting the criteria for classification for developmental
effects. The adverse effects in the embryo/fetus shall be first
considered, and then maternal toxicity, along with any other factors
which are likely to have influenced these effects, as weight of
evidence, to help reach a conclusion about classification.
A.7.2.4.2 Based on pragmatic observation, it is believed that
maternal toxicity may, depending on severity, influence development
via non-specific secondary mechanisms, producing effects such as
depressed fetal weight, retarded ossification, and possibly
resorptions and certain malformations in some strains of certain
species. However, the limited numbers of studies which have
investigated the relationship between developmental effects and
general maternal toxicity have failed to demonstrate a consistent,
reproducible relationship across species. Developmental effects
which occur even in the presence of maternal toxicity are considered
to be evidence of developmental toxicity, unless it can be
unequivocally demonstrated on a case by case basis that the
developmental effects are secondary to maternal toxicity. Moreover,
classification shall be considered where there is a significant
toxic effect in the offspring, e.g., irreversible effects such as
structural malformations, embryo/fetal lethality, or significant
post-natal functional deficiencies.
A.7.2.4.3 Classification shall not automatically be discounted
for chemicals that produce developmental toxicity only in
association with maternal toxicity, even if a specific maternally-
mediated mechanism has been demonstrated. In such a case,
classification in Category 2 may be considered more appropriate than
Category 1. However, when a chemical is so toxic that maternal death
or severe inanition results, or the dams (mothers) are prostrate and
incapable of nursing the pups, it is reasonable to assume that
developmental toxicity is produced solely as a secondary consequence
of maternal toxicity and discount the developmental effects.
Classification is not necessarily the outcome in the case of minor
developmental changes, e.g., a small reduction in fetal/pup body
weight or retardation of ossification when seen in association with
maternal toxicity.
A.7.2.4.4 Some of the endpoints used to assess maternal toxicity
are provided below. Data on these endpoints, if available, shall be
evaluated in light of their statistical or biological significance
and dose-response relationship.
(a) Maternal mortality: An increased incidence of mortality
among the treated dams over the controls shall be considered
evidence of maternal toxicity if the increase occurs in a dose-
related manner and can be attributed to the systemic toxicity of the
test material. Maternal mortality greater than 10% is considered
excessive and the data for that dose level shall not normally be
considered to need further evaluation.
(b) Mating index (Number of animals with seminal plugs or sperm/
Number of mated x 100).
[[Page 9749]]
(c) Fertility index (Number of animals with implants/Number of
matings x 100).
(d) Gestation length (If allowed to deliver).
(e) Body weight and body weight change: Consideration of the
maternal body weight change and/or adjusted (corrected) maternal
body weight shall be included in the evaluation of maternal toxicity
whenever such data are available. The calculation of an adjusted
(corrected) mean maternal body weight change, which is the
difference between the initial and terminal body weight minus the
gravid uterine weight (or alternatively, the sum of the weights of
the fetuses), may indicate whether the effect is maternal or
intrauterine. In rabbits, the body weight gain may not be a useful
indicator of maternal toxicity because of normal fluctuations in
body weight during pregnancy.
(f) Food and water consumption (if relevant): The observation of
a significant decrease in the average food or water consumption in
treated dams (mothers) compared to the control group may be useful
in evaluating maternal toxicity, particularly when the test material
is administered in the diet or drinking water. Changes in food or
water consumption must be evaluated in conjunction with maternal
body weights when determining if the effects noted are reflective of
maternal toxicity or more simply, unpalatability of the test
material in feed or water.
(g) Clinical evaluations (including clinical signs, markers, and
hematology and clinical chemistry studies): The observation of
increased incidence of significant clinical signs of toxicity in
treated dams (mothers) relative to the control group is useful in
evaluating maternal toxicity. If this is to be used as the basis for
the assessment of maternal toxicity, the types, incidence, degree
and duration of clinical signs shall be reported in the study.
Clinical signs of maternal intoxication include, but are not limited
to: Coma, prostration, hyperactivity, loss of righting reflex,
ataxia, or labored breathing.
(h) Post-mortem data: Increased incidence and/or severity of
post-mortem findings may be indicative of maternal toxicity. This
can include gross or microscopic pathological findings or organ
weight data, including absolute organ weight, organ-to-body weight
ratio, or organ-to-brain weight ratio. When supported by findings of
adverse histopathological effects in the affected organ(s), the
observation of a significant change in the average weight of
suspected target organ(s) of treated dams (mothers), compared to
those in the control group, may be considered evidence of maternal
toxicity.
A.7.2.5 Animal and Experimental Data
A.7.2.5.1 A number of scientifically validated test methods are
available, including methods for developmental toxicity testing
(e.g., OECD Test Guideline 414, ICH Guideline S5A, 1993), methods
for peri- and post-natal toxicity testing (e.g., ICH S5B, 1995), and
methods for one or two-generation toxicity testing (e.g., OECD Test
Guidelines 415, 416, 443).
A.7.2.5.2 Results obtained from screening tests (e.g., OECD
Guidelines 421--Reproduction/Developmental Toxicity Screening Test,
and 422--Combined Repeated Dose Toxicity Study with Reproduction/
Development Toxicity Screening Test) can also be used to justify
classification, although the quality of this evidence is less
reliable than that obtained through full studies.
A.7.2.5.3 Adverse effects or changes, seen in short- or long-
term repeated dose toxicity studies, which are judged likely to
impair reproductive function and which occur in the absence of
significant generalized toxicity, may be used as a basis for
classification, e.g., histopathological changes in the gonads.
A.7.2.5.4 Evidence from in vitro assays, or non-mammalian tests,
and from analogous substances using structure-activity relationship
(SAR), can contribute to the procedure for classification. In all
cases of this nature, expert judgment must be used to assess the
adequacy of the data. Inadequate data shall not be used as a primary
support for classification.
A.7.2.5.5 It is preferable that animal studies are conducted
using appropriate routes of administration which relate to the
potential route of human exposure. However, in practice,
reproductive toxicity studies are commonly conducted using the oral
route, and such studies will normally be suitable for evaluating the
hazardous properties of the substance with respect to reproductive
toxicity. However, if it can be conclusively demonstrated that the
clearly identified mechanism or mode of action has no relevance for
humans or when the toxicokinetic differences are so marked that it
is certain that the hazardous property will not be expressed in
humans then a substance which produces an adverse effect on
reproduction in experimental animals should not be classified.
A.7.2.5.6 Studies involving routes of administration such as
intravenous or intraperitoneal injection, which may result in
exposure of the reproductive organs to unrealistically high levels
of the test substance, or elicit local damage to the reproductive
organs, e.g., by irritation, must be interpreted with extreme
caution and on their own are not normally the basis for
classification.
A.7.2.5.7 There is general agreement about the concept of a
limit dose, above which the production of an adverse effect may be
considered to be outside the criteria which lead to classification.
Some test guidelines specify a limit dose, other test guidelines
qualify the limit dose with a statement that higher doses may be
necessary if anticipated human exposure is sufficiently high that an
adequate margin of exposure would not be achieved. Also, due to
species differences in toxicokinetics, establishing a specific limit
dose may not be adequate for situations where humans are more
sensitive than the animal model.
A.7.2.5.8 In principle, adverse effects on reproduction seen
only at very high dose levels in animal studies (for example doses
that induce prostration, severe inappetence, excessive mortality) do
not normally lead to classification, unless other information is
available, for example, toxicokinetics information indicating that
humans may be more susceptible than animals, to suggest that
classification is appropriate.
A.7.2.5.9 However, specification of the actual ``limit dose''
will depend upon the test method that has been employed to provide
the test results.
A.7.3 Classification Criteria for Mixtures 9
---------------------------------------------------------------------------
\9\ It should be noted that the classification criteria for
health hazards usually include a tiered scheme in which test data
available on the complete mixture are considered as the first tier
in the evaluation, followed by the applicable bridging principles,
and lastly, cut-off values/concentration limits or additivity.
However, this approach is not used for Reproductive Toxicity. These
criteria for Reproductive Toxicity consider the cut-off values/
concentration limits as the primary tier and allow the
classification to be modified only on a case-by-case evaluation
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------
A.7.3.1 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.7.3.1.1 The mixture shall be classified as a reproductive
toxicant when at least one ingredient has been classified as a
Category 1 or Category 2 reproductive toxicant and is present at or
above the appropriate cut-off value/concentration limit specified in
Table A.7.1 for Category 1 and 2, respectively.
A.7.3.1.2 The mixture shall be classified for effects on or via
lactation when at least one ingredient has been classified for
effects on or via lactation and is present at or above the
appropriate cut-off value/concentration limit specified in Table
A.7.1 for the additional category for effects on or via lactation.
[[Page 9750]]
Table A.7.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Reproductive
Toxicants or for Effects on or Via Lactation That Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
Cut-off values/concentration limits triggering
classification of a mixture as:
----------------------------------------------------
Ingredient classified as: Category 1 Category 2 Additional category
reproductive reproductive for effects on or
toxicant toxicant via lactation
----------------------------------------------------------------------------------------------------------------
Category 1 reproductive toxicant........................... >=0.1%
Category 2 reproductive toxicant........................... .............. >=0.1%
Additional category for effects on or via lactation........ .............. .............. >=0.1%
----------------------------------------------------------------------------------------------------------------
A.7.3.2 Classification of Mixtures When Data Are Available for the
Complete Mixture
Available test data for the mixture as a whole may be used for
classification on a case-by-case basis. In such cases, the test
results for the mixture as a whole must be shown to be conclusive
taking into account dose and other factors such as duration,
observations and analysis (e.g., statistical analysis, test
sensitivity) of reproduction test systems.
A.7.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.7.3.3.1 Where the mixture itself has not been tested to
determine its reproductive toxicity, but there are sufficient data
on both the individual ingredients and similar tested mixtures to
adequately characterize the hazards of the mixture, these data shall
be used in accordance with the following bridging principles as
found in paragraph A.0.5 of this appendix: Dilution, Batching, and
Substantially similar mixtures.
A.8 Specific Target Organ Toxicity Single Exposure
A.8.1 Definitions and General Considerations
A.8.1.1 Specific target organ toxicity--single exposure, (STOT-
SE) refers to specific, non-lethal toxic effects on target organs
occurring after a single exposure to a substance or mixture. All
significant health effects that can impair function, both reversible
and irreversible, immediate and/or delayed and not specifically
addressed in A.1 to A.7 and A.10 of this appendix are included.
Specific target organ toxicity following repeated exposure is
classified in accordance with SPECIFIC TARGET ORGAN TOXICITY--
REPEATED EXPOSURE (A.9 of this appendix) and is therefore not
included here.
A.8.1.2 Classification identifies the chemical as being a
specific target organ toxicant and, as such, it presents a potential
for adverse health effects in people who are exposed to it.
A.8.1.3 The adverse health effects produced by a single exposure
include consistent and identifiable toxic effects in humans; or, in
experimental animals, toxicologically significant changes which have
affected the function or morphology of a tissue/organ, or have
produced serious changes to the biochemistry or hematology of the
organism, and these changes are relevant for human health. Human
data is the primary source of evidence for this hazard class.
A.8.1.4 Assessment shall take into consideration not only
significant changes in a single organ or biological system but also
generalized changes of a less severe nature involving several
organs.
A.8.1.5 Specific target organ toxicity can occur by any route
that is relevant for humans, i.e., principally oral, dermal or
inhalation.
A.8.1.6 The classification criteria for specific target organ
toxicity--single exposure are organized as criteria for substances
Categories 1 and 2 (See A.8.2.1), criteria for substances Category 3
(See A.8.2.2) and criteria for mixtures (See A.8.3). See also Figure
A.8.1.
A.8.2 Classification Criteria for Substances
A.8.2.1 Substances of Category 1 and Category 2
A.8.2.1.1 Substances shall be classified for immediate or
delayed effects separately, by the use of expert judgment on the
basis of the weight of all evidence available, including the use of
recommended guidance values (See A.8.2.1.9). Substances shall then
be classified in Category 1 or 2, depending upon the nature and
severity of the effect(s) observed, in accordance with Figure A.8.1.
Figure A.8.1--Hazard Categories for Specific Target Organ Toxicity
Following Single Exposure
------------------------------------------------------------------------
-------------------------------------------------------------------------
CATEGORY 1: Substances that have produced significant toxicity in
humans, or that, on the basis of evidence from studies in experimental
animals can be presumed to have the potential to produce significant
toxicity in humans following single exposure: Substances are classified
in Category 1 for STOT-SE on the basis of:
(a) Reliable and good quality evidence from human cases or
epidemiological studies; or
(b) observations from appropriate studies in experimental animals in
which significant and/or severe toxic effects of relevance to human
health were produced at generally low exposure concentrations.
Guidance dose/concentration values are provided below (See
A.8.2.1.9) to be used as part of weight-of-evidence evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in
experimental animals, can be presumed to have the potential to be
harmful to human health following single exposure: Substances are
classified in Category 2 for STOT-SE on the basis of observations from
appropriate studies in experimental animals in which significant toxic
effects, of relevance to human health, were produced at generally
moderate exposure concentrations. Guidance dose/concentration values
are provided below (See A.8.2.1.9) in order to help in classification.
In exceptional cases, human evidence can also be used to place a
substance in Category 2 (See A.8.2.1.6).
CATEGORY 3: Transient target organ effects: There are target organ
effects for which a substance does not meet the criteria to be
classified in Categories 1 or 2 indicated above. These are effects
which adversely alter human function for a short duration after
exposure and from which humans may recover in a reasonable period
without leaving significant alteration of structure or function. This
category only includes narcotic effects and respiratory tract
irritation. Substances are classified specifically for these effects as
discussed in A.8.2.2.
------------------------------------------------------------------------
Note: The primary target organ/system shall be identified where
possible, and where this is not possible, the substance shall be
identified as a general toxicant. The data shall be evaluated and,
where possible, shall not include secondary effects (e.g., a
hepatotoxicant can produce secondary effects in the nervous or gastro-
intestinal systems).
A.8.2.1.2 The relevant route(s) of exposure by which the
classified substance produces damage shall be identified.
A.8.2.1.3 Classification is determined by expert judgment, on
the basis of the weight of all evidence available including the
guidance presented below.
[[Page 9751]]
A.8.2.1.4 Weight of evidence of all available data, including
human incidents, epidemiology, and studies conducted in experimental
animals is used to substantiate specific target organ toxic effects
that merit classification.
A.8.2.1.5 The information required to evaluate specific target
organ toxicity comes either from single exposure in humans (e.g.,
exposure at home, in the workplace or environmentally), or from
studies conducted in experimental animals. The standard animal
studies in rats or mice that provide this information are acute
toxicity studies which can include clinical observations and
detailed macroscopic and microscopic examination to enable the toxic
effects on target tissues/organs to be identified. Results of acute
toxicity studies conducted in other species may also provide
relevant information.
A.8.2.1.6 In exceptional cases, based on expert judgment, it may
be appropriate to place certain substances with human evidence of
target organ toxicity in Category 2: (a) When the weight of human
evidence is not sufficiently convincing to warrant Category 1
classification, and/or (b) based on the nature and severity of
effects. Dose/concentration levels in humans shall not be considered
in the classification and any available evidence from animal studies
shall be consistent with the Category 2 classification. In other
words, if there are also animal data available on the substance that
warrant Category 1 classification, the chemical shall be classified
as Category 1.
A.8.2.1.7 Effects considered to support classification for
Category 1 and 2.
A.8.2.1.7.1 Classification is supported by evidence associating
single exposure to the substance with a consistent and identifiable
toxic effect.
A.8.2.1.7.2 Evidence from human experience/incidents is usually
restricted to reports of adverse health consequences, often with
uncertainty about exposure conditions, and may not provide the
scientific detail that can be obtained from well-conducted studies
in experimental animals.
A.8.2.1.7.3 Evidence from appropriate studies in experimental
animals can furnish much more detail, in the form of clinical
observations, and macroscopic and microscopic pathological
examination and this can often reveal hazards that may not be life-
threatening but could indicate functional impairment. Consequently,
all available evidence, and relevance to human health, must be taken
into consideration in the classification process. Relevant toxic
effects in humans and/or animals include, but are not limited to:
(a) Morbidity resulting from single exposure;
(b) Significant functional changes, more than transient in
nature, in the respiratory system, central or peripheral nervous
systems, other organs or other organ systems, including signs of
central nervous system depression and effects on special senses
(e.g., sight, hearing and sense of smell);
(c) Any consistent and significant adverse change in clinical
biochemistry, hematology, or urinalysis parameters;
(d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis or granuloma
formation in vital organs with regenerative capacity;
(f) Morphological changes that are potentially reversible but
provide clear evidence of marked organ dysfunction; and,
(g) Evidence of appreciable cell death (including cell
degeneration and reduced cell number) in vital organs incapable of
regeneration.
A.8.2.1.8 Effects considered not to support classification for
Category 1 and 2.
Effects may be seen in humans and/or animals that do not justify
classification. Such effects include, but are not limited to:
(a) Clinical observations or small changes in bodyweight gain,
food consumption or water intake that may have some toxicological
importance but that do not, by themselves, indicate ``significant''
toxicity;
(b) Small changes in clinical biochemistry, hematology or
urinalysis parameters and/or transient effects, when such changes or
effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ
dysfunction;
(d) Adaptive responses that are not considered toxicologically
relevant; and,
(e) Substance-induced species-specific mechanisms of toxicity,
i.e., demonstrated with reasonable certainty to be not relevant for
human health, shall not justify classification.
A.8.2.1.9 Guidance values to assist with classification based on
the results obtained from studies conducted in experimental animals
for Category 1 and 2.
A.8.2.1.9.1 In order to help reach a decision about whether a
substance shall be classified or not, and to what degree it shall be
classified (Category 1 vs. Category 2), dose/concentration
``guidance values'' are provided for consideration of the dose/
concentration which has been shown to produce significant health
effects. The principal argument for proposing such guidance values
is that all chemicals are potentially toxic and there has to be a
reasonable dose/concentration above which a degree of toxic effect
is acknowledged.
A.8.2.1.9.2 Thus, in animal studies, when significant toxic
effects are observed that indicate classification, consideration of
the dose/concentration at which these effects were seen, in relation
to the suggested guidance values, provides useful information to
help assess the need to classify (since the toxic effects are a
consequence of the hazardous property(ies) and also the dose/
concentration).
A.8.2.1.9.3 The guidance value (C) ranges for single-dose
exposure which has produced a significant non-lethal toxic effect
are those applicable to acute toxicity testing, as indicated in
Table A.8.1.
Table A.8.1--Guidance Value Ranges for Single-Dose Exposures
----------------------------------------------------------------------------------------------------------------
Guidance value ranges for:
----------------------------------------------------------------------------------------------------------------
Route of exposure Units Category 1 Category 2 Category 3
----------------------------------------------------------------------------------------------------------------
Oral (rat)...................... mg/kg body weight. C <= 300.......... 2,000 >= C > 300.. Guidance values do
not apply.
Dermal (rat or rabbit).......... mg/kg body weight. C <= 1,000........ 2,000 >= C > 1,000
Inhalation (rat) gas............ ppmV/4h........... C <= 2,500........ 20,000 >= C >
2,500.
Inhalation (rat) vapor.......... mg/1/4h........... C <= 10........... 20 >= C > 10......
Inhalation (rat) dust/mist/fume. mg/l/4h........... C <= 1.0.......... 5.0 >= C > 1.0....
----------------------------------------------------------------------------------------------------------------
A.8.2.1.9.4 The guidance values and ranges mentioned in Table
A.8.1 are intended only for guidance purposes, i.e., to be used as
part of the weight of evidence approach, and to assist with
decisions about classification. They are not intended as strict
demarcation values. Guidance values are not provided for Category 3
since this classification is primarily based on human data; animal
data may be included in the weight of evidence evaluation.
A.8.2.1.9.5 Thus, it is feasible that a specific profile of
toxicity occurs at a dose/concentration below the guidance value,
e.g., <2,000 mg/kg body weight by the oral route, however the nature
of the effect may result in the decision not to classify.
Conversely, a specific profile of toxicity may be seen in animal
studies occurring at above a guidance value, e.g., >=2,000 mg/kg
body weight by the oral route, and in addition there is
supplementary information from other sources, e.g., other single
dose studies, or human case experience, which supports a conclusion
that, in view of the weight of evidence, classification is the
prudent action to take.
A.8.2.1.10 Other considerations.
A.8.2.1.10.1 When a substance is characterized only by use of
animal data the classification process includes reference to dose/
concentration guidance values as one of
[[Page 9752]]
the elements that contribute to the weight of evidence approach.
A.8.2.1.10.2 When well-substantiated human data are available
showing a specific target organ toxic effect that can be reliably
attributed to single exposure to a substance, the substance shall be
classified. Positive human data, regardless of probable dose,
predominates over animal data. Thus, if a substance is unclassified
because specific target organ toxicity observed was considered not
relevant or significant to humans, if subsequent human incident data
become available showing a specific target organ toxic effect, the
substance shall be classified.
A.8.2.1.10.3 A substance that has not been tested for specific
target organ toxicity shall, where appropriate, be classified on the
basis of data from a scientifically validated structure activity
relationship and expert judgment-based extrapolation from a
structural analogue that has previously been classified together
with substantial support from consideration of other important
factors such as formation of common significant metabolites.
A.8.2.2 Substances of Category 3
A.8.2.2.1 Criteria for respiratory tract irritation.
The criteria for classifying substances as Category 3 for
respiratory tract irritation are:
(a) Respiratory irritant effects (characterized by localized
redness, edema, pruritis and/or pain) that impair function with
symptoms such as cough, pain, choking, and breathing difficulties
are included. It is recognized that this evaluation is based
primarily on human data;
(b) Subjective human observations supported by objective
measurements of clear respiratory tract irritation (RTI) (e.g.,
electrophysiological responses, biomarkers of inflammation in nasal
or bronchoalveolar lavage fluids);
(c) The symptoms observed in humans shall also be typical of
those that would be produced in the exposed population rather than
being an isolated idiosyncratic reaction or response triggered only
in individuals with hypersensitive airways. Ambiguous reports simply
of ``irritation'' should be excluded as this term is commonly used
to describe a wide range of sensations including those such as
smell, unpleasant taste, a tickling sensation, and dryness, which
are outside the scope of classification for respiratory tract
irritation;
(d) There are currently no scientifically validated animal tests
that deal specifically with RTI; however, useful information may be
obtained from the single and repeated inhalation toxicity tests. For
example, animal studies may provide useful information in terms of
clinical signs of toxicity (dyspnoea, rhinitis etc.) and
histopathology (e.g., hyperemia, edema, minimal inflammation,
thickened mucous layer) which are reversible and may be reflective
of the characteristic clinical symptoms described above. Such animal
studies can be used as part of weight of evidence evaluation; and,
(e) This special classification will occur only when more severe
organ effects including the respiratory system are not observed as
those effects would require a higher classification.
A.8.2.2.2 Criteria for narcotic effects.
The criteria for classifying substances in Category 3 for
narcotic effects are:
(a) Central nervous system depression including narcotic effects
in humans such as drowsiness, narcosis, reduced alertness, loss of
reflexes, lack of coordination, and vertigo are included. These
effects can also be manifested as severe headache or nausea, and can
lead to reduced judgment, dizziness, irritability, fatigue, impaired
memory function, deficits in perception and coordination, reaction
time, or sleepiness; and,
(b) Narcotic effects observed in animal studies may include
lethargy, lack of coordination righting reflex, narcosis, and
ataxia. If these effects are not transient in nature, then they
shall be considered for classification as Category 1 or 2.
A.8.3 Classification Criteria for Mixtures
A.8.3.1 Mixtures are classified using the same criteria as for
substances, or alternatively as described below. As with substances,
mixtures may be classified for specific target organ toxicity
following single exposure, repeated exposure, or both.
A.8.3.2 Classification of Mixtures When Data Are Available for the
Complete Mixture
When reliable and good quality evidence from human experience or
appropriate studies in experimental animals, as described in the
criteria for substances, is available for the mixture, then the
mixture shall be classified by weight of evidence evaluation of this
data. Care shall be exercised in evaluating data on mixtures, that
the dose, duration, observation or analysis, do not render the
results inconclusive.
A.8.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.8.3.3.1 Where the mixture itself has not been tested to
determine its specific target organ toxicity, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data shall be used in accordance with the following
bridging principles as found in paragraph A.0.5 of this appendix:
Dilution, Batching, Concentration of mixtures, Interpolation within
one hazard category, Substantially similar mixtures, or Aerosols.
A.8.3.4 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.8.3.4.1 Where there is no reliable evidence or test data for
the specific mixture itself, and the bridging principles cannot be
used to enable classification, then classification of the mixture is
based on the classification of the ingredient substances. In this
case, the mixture shall be classified as a specific target organ
toxicant (specific organ specified), following single exposure,
repeated exposure, or both when at least one ingredient has been
classified as a Category 1 or Category 2 specific target organ
toxicant and is present at or above the appropriate cut-off value/
concentration limit specified in Table A.8.2 for Categories 1 and 2,
respectively.
Table A.8.2--Cut-Off Values/Concentration Limits of Ingredients of a
Mixture Classified as a Specific Target Organ Toxicant That Would
Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
Cut-off values/concentration
limits triggering
classification of a mixture
Ingredient classified as: as:
-------------------------------
Category 1 Category 2
------------------------------------------------------------------------
Category 1: Target organ toxicant....... >=1.0% ..............
Category 2: Target organ toxicant....... .............. >=1.0%
------------------------------------------------------------------------
A.8.3.4.2 These cut-off values and consequent classifications
shall be applied equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.8.3.4.3 Mixtures shall be classified for either or both single
and repeated dose toxicity independently.
A.8.3.4.4 Care shall be exercised when toxicants affecting more
than one organ system are combined that the potentiation or
synergistic interactions are considered, because certain substances
can cause target organ toxicity at <1% concentration when other
ingredients in the mixture are known to potentiate its toxic effect.
A.8.3.4.5 Care shall be exercised when extrapolating the
toxicity of a mixture that contains Category 3 ingredient(s). A cut-
off value/concentration limit of 20%, considered as an additive of
all Category 3 ingredients for each hazard endpoint, is appropriate;
however, this cut-off value/concentration limit may be higher or
lower depending on the Category 3 ingredient(s) involved and the
fact that some effects such as respiratory tract irritation may not
occur below a certain concentration while other effects such as
narcotic effects may occur below this 20% value. Expert judgment
shall be exercised. Respiratory tract irritation and narcotic
[[Page 9753]]
effects are to be evaluated separately in accordance with the
criteria given in A.8.2.2. When conducting classifications for these
hazards, the contribution of each ingredient should be considered
additive, unless there is evidence that the effects are not
additive.
A.8.3.4.6 In cases where the additivity approach is used for
Category 3 ingredients, the ``relevant ingredients'' of a mixture
are those which are present in concentrations >=1% (w/w for solids,
liquids, dusts, mists, and vapours and v/v for gases), unless there
is a reason to suspect that an ingredient present at a concentration
<1% is still relevant when classifying the mixture for respiratory
tract irritation or narcotic effects.
A.9 Specific Target Organ Toxicity Repeated or Prolonged Exposure
A.9.1 Definitions and General Considerations
A.9.1.1 Specific target organ toxicity--repeated exposure (STOT-
RE) refers to specific toxic effects on target organs occurring
after repeated exposure to a substance or mixture. All significant
health effects that can impair function, both reversible and
irreversible, immediate and/or delayed and not specifically
addressed in A.1 to A.7 and A.10 of this appendix are included.
Specific target organ toxicity following a single-event exposure is
classified in accordance with SPECIFIC TARGET ORGAN TOXICITY-SINGLE
EXPOSURE (A.8 of this appendix) and is therefore not included here.
A.9.1.2 Classification identifies the substance or mixture as
being a specific target organ toxicant and, as such, it may present
a potential for adverse health effects in people who are exposed to
it.
A.9.1.3 These adverse health effects produced by repeated
exposure include consistent and identifiable toxic effects in
humans, or, in experimental animals, toxicologically significant
changes which have affected the function or morphology of a tissue/
organ, or have produced serious changes to the biochemistry or
hematology of the organism and these changes are relevant for human
health. Human data will be the primary source of evidence for this
hazard class.
A.9.1.4 Assessment shall take into consideration not only
significant changes in a single organ or biological system but also
generalized changes of a less severe nature involving several
organs.
A.9.1.5 Specific target organ toxicity can occur by any route
that is relevant for humans, e.g., principally oral, dermal or
inhalation.
A.9.2 Classification Criteria for Substances
A.9.2.1 Substances shall be classified as STOT-RE by expert
judgment on the basis of the weight of all evidence available,
including the use of recommended guidance values which take into
account the duration of exposure and the dose/concentration which
produced the effect(s), (See A.9.2.9). Substances shall be placed in
one of two categories, depending upon the nature and severity of the
effect(s) observed, in accordance with Figure A.9.1.
Figure A.9.1--Hazard Categories for Specific Target Organ Toxicity
Following Repeated Exposure
------------------------------------------------------------------------
-------------------------------------------------------------------------
CATEGORY 1: Substances that have produced significant toxicity in
humans, or that, on the basis of evidence from studies in experimental
animals can be presumed to have the potential to produce significant
toxicity in humans following repeated or prolonged exposure. Substances
are classified in Category 1 for specific target organ toxicity
(repeated exposure) on the basis of:
(a) Reliable and good quality evidence from human cases or
epidemiological studies; or,
(b) observations from appropriate studies in experimental animals in
which significant and/or severe toxic effects, of relevance to
human health, were produced at generally low exposure
concentrations. Guidance dose/concentration values are provided
below (See A.9.2.9) to be used as part of weight-of-evidence
evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in
experimental animals can be presumed to have the potential to be
harmful to human health following repeated or prolonged exposure.
Substances are classified in Category 2 for specific target organ
toxicity (repeated exposure) on the basis of observations from
appropriate studies in experimental animals in which significant toxic
effects, of relevance to human health, were produced at generally
moderate exposure concentrations. Guidance dose/concentration values
are provided below (See A.9.2.9) in order to help in classification. In
exceptional cases human evidence can also be used to place a substance
in Category 2 (See A.9.2.6).
------------------------------------------------------------------------
Note: The primary target organ/system shall be identified where
possible, or the substance shall be identified as a general toxicant.
The data shall be carefully evaluated and, where possible, shall not
include secondary effects (e.g., a hepatotoxicant can produce
secondary effects in the nervous or gastro-intestinal systems).
A.9.2.2 The relevant route of exposure by which the classified
substance produces damage shall be identified.
A.9.2.3 Classification is determined by expert judgment, on the
basis of the weight of all evidence available including the guidance
presented below.
A.9.2.4 Weight of evidence of all data, including human
incidents, epidemiology, and studies conducted in experimental
animals, is used to substantiate specific target organ toxic effects
that merit classification.
A.9.2.5 The information required to evaluate specific target
organ toxicity comes either from repeated exposure in humans, e.g.,
exposure at home, in the workplace or environmentally, or from
studies conducted in experimental animals. The standard animal
studies in rats or mice that provide this information are 28 day, 90
day or lifetime studies (up to 2 years) that include hematological,
clinico-chemical and detailed macroscopic and microscopic
examination to enable the toxic effects on target tissues/organs to
be identified. Data from repeat dose studies performed in other
species may also be used. Other long-term exposure studies, e.g.,
for carcinogenicity, neurotoxicity or reproductive toxicity, may
also provide evidence of specific target organ toxicity that could
be used in the assessment of classification.
A.9.2.6 In exceptional cases, based on expert judgment, it may
be appropriate to place certain substances with human evidence of
specific target organ toxicity in Category 2: (a) When the weight of
human evidence is not sufficiently convincing to warrant Category 1
classification, and/or (b) based on the nature and severity of
effects. Dose/concentration levels in humans shall not be considered
in the classification and any available evidence from animal studies
shall be consistent with the Category 2 classification. In other
words, if there are also animal data available on the substance that
warrant Category 1 classification, the substance shall be classified
as Category 1.
A.9.2.7 Effects Considered To Support Classification
A.9.2.7.1 Classification is supported by reliable evidence
associating repeated exposure to the substance with a consistent and
identifiable toxic effect.
A.9.2.7.2 Evidence from human experience/incidents is usually
restricted to reports of adverse health consequences, often with
uncertainty about exposure conditions, and may not provide the
scientific detail that can be obtained from well-conducted studies
in experimental animals.
A.9.2.7.3 Evidence from appropriate studies in experimental
animals can furnish much more detail, in the form of clinical
observations, hematology, clinical chemistry, macroscopic and
microscopic pathological examination and this can often reveal
hazards that may not be life-threatening but could indicate
functional impairment. Consequently, all available evidence, and
relevance to human health, must be taken into consideration in the
classification process. Relevant toxic effects in humans and/or
animals include, but are not limited to:
(a) Morbidity or death resulting from repeated or long-term
exposure. Morbidity or death may result from repeated exposure, even
to relatively low doses/concentrations, due to bioaccumulation of
the substance or its metabolites, or due to the overwhelming of the
de-toxification process by repeated exposure;
(b) Significant functional changes in the central or peripheral
nervous systems or other organ systems, including signs of
[[Page 9754]]
central nervous system depression and effects on special senses
(e.g., sight, hearing and sense of smell);
(c) Any consistent and significant adverse change in clinical
biochemistry, hematology, or urinalysis parameters;
(d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis or granuloma
formation in vital organs with regenerative capacity;
(f) Morphological changes that are potentially reversible but
provide clear evidence of marked organ dysfunction (e.g., severe
fatty change in the liver); and,
(g) Evidence of appreciable cell death (including cell
degeneration and reduced cell number) in vital organs incapable of
regeneration.
A.9.2.8 Effects Considered Not To Support Classification
Effects may be seen in humans and/or animals that do not justify
classification. Such effects include, but are not limited to:
(a) Clinical observations or small changes in bodyweight gain,
food consumption or water intake that may have some toxicological
importance but that do not, by themselves, indicate ``significant''
toxicity;
(b) Small changes in clinical biochemistry, hematology or
urinalysis parameters and/or transient effects, when such changes or
effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ
dysfunction;
(d) Adaptive responses that are not considered toxicologically
relevant;
(e) Substance-induced species-specific mechanisms of toxicity,
i.e., demonstrated with reasonable certainty to be not relevant for
human health, shall not justify classification.
A.9.2.9 Guidance Values To Assist With Classification Based on the
Results Obtained From Studies Conducted in Experimental Animals
A.9.2.9.1 In studies conducted in experimental animals, reliance
on observation of effects alone, without reference to the duration
of experimental exposure and dose/concentration, omits a fundamental
concept of toxicology, i.e., all substances are potentially toxic,
and what determines the toxicity is a function of the dose/
concentration and the duration of exposure. In most studies
conducted in experimental animals the test guidelines use an upper
limit dose value.
A.9.2.9.2 In order to help reach a decision about whether a
substance shall be classified or not, and to what degree it shall be
classified (Category 1 vs. Category 2), dose/concentration
``guidance values'' are provided in Table A.9.1 for consideration of
the dose/concentration which has been shown to produce significant
health effects. The principal argument for proposing such guidance
values is that all chemicals are potentially toxic and there has to
be a reasonable dose/concentration above which a degree of toxic
effect is acknowledged. Also, repeated-dose studies conducted in
experimental animals are designed to produce toxicity at the highest
dose used in order to optimize the test objective and so most
studies will reveal some toxic effect at least at this highest dose.
What is therefore to be decided is not only what effects have been
produced, but also at what dose/concentration they were produced and
how relevant is that for humans.
A.9.2.9.3 Thus, in animal studies, when significant toxic
effects are observed that indicate classification, consideration of
the duration of experimental exposure and the dose/concentration at
which these effects were seen, in relation to the suggested guidance
values, provides useful information to help assess the need to
classify (since the toxic effects are a consequence of the hazardous
property(ies) and also the duration of exposure and the dose/
concentration).
A.9.2.9.4 The decision to classify at all can be influenced by
reference to the dose/concentration guidance values at or below
which a significant toxic effect has been observed.
A.9.2.9.5 The guidance values refer to effects seen in a
standard 90-day toxicity study conducted in rats. They can be used
as a basis to extrapolate equivalent guidance values for toxicity
studies of greater or lesser duration, using dose/exposure time
extrapolation similar to Haber's rule for inhalation, which states
essentially that the effective dose is directly proportional to the
exposure concentration and the duration of exposure. The assessment
should be done on a case-by-case basis; for example, for a 28-day
study the guidance values below would be increased by a factor of
three.
A.9.2.9.6 Thus for Category 1 classification, significant toxic
effects observed in a 90-day repeated-dose study conducted in
experimental animals and seen to occur at or below the (suggested)
guidance values (C) as indicated in Table A.9.1 would justify
classification:
Table A.9.1--Guidance Values To Assist in Category 1 Classification
[Applicable to a 90-day study]
------------------------------------------------------------------------
Guidance values
Route of exposure Units (dose/
concentration)
------------------------------------------------------------------------
Oral (rat)...................... mg/kg body weight/ C <=10
day.
Dermal (rat or rabbit).......... mg/kg body weight/ C <=20
day.
Inhalation (rat) gas............ ppmV/6h/day....... C <=50
Inhalation (rat) vapor.......... mg/liter/6h/day... C <=0.2
Inhalation (rat) dust/mist/fume. mg/liter/6h/day... C <=0.02
------------------------------------------------------------------------
A.9.2.9.7 For Category 2 classification, significant toxic
effects observed in a 90-day repeated-dose study conducted in
experimental animals and seen to occur within the (suggested)
guidance value ranges as indicated in Table A.9.2 would justify
classification:
Table A.9.2--Guidance Values To Assist in Category 2 Classification
[Applicable to a 90-day study]
------------------------------------------------------------------------
Guidance value
Route of exposure Units range (dose/
concentration)
------------------------------------------------------------------------
Oral (rat)...................... mg/kg body weight/ 10 =100 mg/kg body weight/day by the oral route, and in addition there
is supplementary information from other sources, e.g., other long-
term administration studies, or human case experience, which
supports a conclusion that, in view of the weight of evidence,
classification is prudent.
A.9.2.10 Other Considerations
A.9.2.10.1 When a substance is characterized only by use of
animal data the classification process includes reference to dose/
concentration guidance values as one of the elements that contribute
to the weight of evidence approach.
A.9.2.10.2 When well-substantiated human data are available
showing a specific target organ toxic effect that can be reliably
attributed to repeated or prolonged exposure to a substance, the
substance shall be classified. Positive human data, regardless of
probable dose, predominates over animal data. Thus, if a substance
is unclassified because no specific target organ toxicity was seen
at or below the dose/concentration guidance value for animal
testing, if subsequent human incident data become available showing
a specific target organ toxic effect, the substance shall be
classified.
A.9.2.10.3 A substance that has not been tested for specific
target organ toxicity may in certain instances, where appropriate,
be classified on the basis of data from a scientifically validated
structure activity relationship and expert judgment-based
extrapolation from a structural analogue that has previously been
classified together with substantial support from consideration of
other important factors such as formation of common significant
metabolites.
A.9.3 Classification Criteria for Mixtures
A.9.3.1 Mixtures are classified using the same criteria as for
substances, or alternatively as described below. As with substances,
mixtures may be classified for specific target organ toxicity
following single exposure, repeated exposure, or both.
A.9.3.2 Classification of Mixtures When Data Are Available for the
Complete Mixture
When reliable and good quality evidence from human experience or
appropriate studies in experimental animals, as described in the
criteria for substances, is available for the mixture, then the
mixture shall be classified by weight of evidence evaluation of
these data. Care shall be exercised in evaluating data on mixtures,
that the dose, duration, observation or analysis, do not render the
results inconclusive.
A.9.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.9.3.3.1 Where the mixture itself has not been tested to
determine its specific target organ toxicity, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data shall be used in accordance with the following
bridging principles as found in paragraph A.0.5 of this appendix:
Dilution; Batching; Concentration of mixtures; Interpolation within
one hazard category; Substantially similar mixtures; and Aerosols.
A.9.3.4 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.9.3.4.1 Where there is no reliable evidence or test data for
the specific mixture itself, and the bridging principles cannot be
used to enable classification, then classification of the mixture is
based on the classification of the ingredient substances. In this
case, the mixture shall be classified as a specific target organ
toxicant (specific organ specified), following single exposure,
repeated exposure, or both when at least one ingredient has been
classified as a Category 1 or Category 2 specific target organ
toxicant and is present at or above the appropriate cut-off value/
concentration limit specified in Table A.9.3 for Category 1 and 2
respectively.
Table A.9.3--Cut-Off Value/Concentration Limits of Ingredients of a
Mixture Classified as a Specific Target Organ Toxicant That Would
Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
Cut-off values/concentration
limits triggering
classification of a mixture
Ingredient classified as: as:
-------------------------------
Category 1 Category 2
------------------------------------------------------------------------
Category 1: Target organ toxicant....... >=1.0% ..............
Category 2: Target organ toxicant....... .............. >=1.0%
------------------------------------------------------------------------
A.9.3.4.2 These cut-off values and consequent classifications
shall be applied equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.9.3.4.3 Mixtures shall be classified for either or both
single- and repeated-dose toxicity independently.
A.9.3.4.4 Care shall be exercised when toxicants affecting more
than one organ system are combined that the potentiation or
synergistic interactions are considered, because certain substances
can cause specific target organ toxicity at <1% concentration when
other ingredients in the mixture are known to potentiate its toxic
effect.
A.10 Aspiration Hazard
A.10.1 Definitions and General Considerations
A.10.1.1 Aspiration hazard refers to severe acute effects such
as chemical pneumonia, pulmonary injury or death occurring after
aspiration of a substance or mixture.
A.10.1.2 Aspiration means the entry of a liquid or solid
chemical directly through the oral or nasal cavity, or indirectly
from vomiting, into the trachea and lower respiratory system.
A.10.1.3 Aspiration is initiated at the moment of inspiration,
in the time required to take one breath, as the causative material
lodges at the crossroad of the upper respiratory and digestive
tracts in the laryngopharyngeal region.
A.10.1.4 Aspiration of a substance or mixture can occur as it is
vomited following ingestion. This may have consequences for
labelling, particularly where, due to acute toxicity, a
recommendation may be considered to induce vomiting after ingestion.
However, if the substance/mixture also presents an aspiration
toxicity hazard, the recommendation to induce vomiting may need to
be modified.
A.10.1.5 Specific Considerations
A.10.1.5.1 The classification criteria refer to kinematic
viscosity. The following provides the conversion between dynamic and
kinematic viscosity:
[GRAPHIC] [TIFF OMITTED] TP16FE21.088
[[Page 9756]]
A.10.1.5.2 Although the definition of aspiration in A.10.1.1
includes the entry of solids into the respiratory system,
classification according to (b) in table A.10.1 for Category 1 is
intended to apply to liquid substances and mixtures only.
A.10.1.5.3 Classification of aerosol/mist products
Aerosol and mist products are usually dispensed in containers
such as self-pressurized containers, trigger and pump sprayers.
Classification for these products shall be considered if their use
may form a pool of product in the mouth, which then may be
aspirated. If the mist or aerosol from a pressurized container is
fine, a pool may not be formed. On the other hand, if a pressurized
container dispenses product in a stream, a pool may be formed that
may then be aspirated. Usually, the mist produced by trigger and
pump sprayers is coarse and therefore, a pool may be formed that
then may be aspirated. When the pump mechanism may be removed and
contents are available to be swallowed then the classification of
the products should be considered.
A.10.2 Classification Criteria for Substances
Table A.10.1--Criteria for Aspiration Toxicity
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
Category 1: Chemicals known to A substance shall be classified in
cause human aspiration toxicity Category 1:
hazards or to be regarded as if (a) If reliable and good quality
they cause human aspiration human evidence indicates that it
toxicity hazard. causes aspiration toxicity (See
note); or
(b) If it is a hydrocarbon and has a
kinematic viscosity <=20.5 mm2/s,
measured at 40 [deg]C.
------------------------------------------------------------------------
Note: Examples of substances included in Category 1 are certain
hydrocarbons, turpentine and pine oil.
A.10.3 Classification Criteria for Mixtures
A.10.3.1 Classification When Data Are Available for the Complete
Mixture
A mixture shall be classified in Category 1 based on reliable
and good quality human evidence.
A.10.3.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.10.3.2.1 Where the mixture itself has not been tested to
determine its aspiration toxicity, but there are sufficient data on
both the individual ingredients and similar tested mixtures to
adequately characterize the hazard of the mixture, these data shall
be used in accordance with the following bridging principles as
found in paragraph A.0.5 of this appendix: Dilution; Batching;
Concentration of mixtures; Interpolation within one hazard category;
and Substantially similar mixtures. For application of the dilution
bridging principle, the concentration of aspiration toxicants shall
not be less than 10%.
A.10.3.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.10.3.3.1 The ``relevant ingredients'' of a mixture are those
which are present in concentrations >=1%.
A.10.3.3.2 Category 1
A.10.3.3.2.1 A mixture is classified as Category 1 when the sum
of the concentrations of Category 1 ingredients is >=10%, and the
mixture has a kinematic viscosity of <=20.5 mm2/s, measured at 40
[deg]C.
A.10.3.3.2.2 In the case of a mixture which separates into two
or more distinct layers, the entire mixture is classified as
Category 1 if in any distinct layer the sum of the concentrations of
Category 1 ingredients is >=10%, and it has a kinematic viscosity of
<=20.5 mm2/s, measured at 40 [deg]C.
Appendix B to Sec. 1910.1200--Physical Hazard Criteria (Mandatory)
B.1 Explosives
B.1.1 Definitions and General Considerations
B.1.1.1 An explosive chemical is a solid or liquid chemical
which is in itself capable by chemical reaction of producing gas at
such a temperature and pressure and at such a speed as to cause
damage to the surroundings. Pyrotechnic chemicals are included even
when they do not evolve gases.
A pyrotechnic chemical is a chemical designed to produce an
effect by heat, light, sound, gas or smoke or a combination of these
as the result of non-detonative self-sustaining exothermic chemical
reactions.
An explosive item is an item containing one or more explosive
chemicals.
A pyrotechnic item is an item containing one or more pyrotechnic
chemicals.
An unstable explosive is an explosive which is thermally
unstable and/or too sensitive for normal handling, transport, or
use.
An intentional explosive is a chemical or item which is
manufactured with a view to produce a practical explosive or
pyrotechnic effect.
B.1.1.2 The class of explosives comprises:
(a) Explosive chemicals;
(b) Explosive items, except devices containing explosive
chemicals in such quantity or of such a character that their
inadvertent or accidental ignition or initiation shall not cause any
effect external to the device either by projection, fire, smoke,
heat or loud noise; and
(c) Chemicals and items not included under (a) and (b) of this
section which are manufactured with the view to producing a
practical explosive or pyrotechnic effect.
B.1.2 Classification Criteria
Chemicals and items of this class shall be classified as
unstable explosives or shall be assigned to one of the following six
divisions depending on the type of hazard they present:
(a) Division 1.1--Chemicals and items which have a mass
explosion hazard (a mass explosion is one which affects almost the
entire quantity present virtually instantaneously);
(b) Division 1.2--Chemicals and items which have a projection
hazard but not a mass explosion hazard;
(c) Division 1.3--Chemicals and items which have a fire hazard
and either a minor blast hazard or a minor projection hazard or
both, but not a mass explosion hazard:
(i) Combustion of which gives rise to considerable radiant heat;
or
(ii) Which burn one after another, producing minor blast or
projection effects or both;
(d) Division 1.4--Chemicals and items which present no
significant hazard: Chemicals and items which present only a small
hazard in the event of ignition or initiation. The effects are
largely confined to the package and no projection of fragments of
appreciable size or range is to be expected. An external fire shall
not cause virtually instantaneous explosion of almost the entire
contents of the package;
(e) Division 1.5--Very insensitive chemicals which have a mass
explosion hazard: Chemicals which have a mass explosion hazard but
are so insensitive that there is very little probability of
initiation or of transition from burning to detonation under normal
conditions;
(f) Division 1.6--Extremely insensitive items which do not have
a mass explosion hazard: Items which predominantly contain extremely
insensitive detonating chemicals and which demonstrate a negligible
probability of accidental initiation or propagation.
B.1.3 Additional Classification Considerations
B.1.3.1 Explosives shall be classified as unstable explosives or
shall be assigned to one of the six divisions identified in B.1.2 in
accordance with the three-step procedure in Part I of the UN ST/SG/
AC.10 (incorporated by reference; See Sec. 1910.6). The first step
is to ascertain whether the substance or mixture has explosive
effects (Test Series 1). The second step is the acceptance procedure
(Test Series 2 to 4) and the third step is the assignment to a
hazard division (Test Series
[[Page 9757]]
5 to 7). The assessment whether a candidate for ``ammonium nitrate
emulsion or suspension or gel, intermediate for blasting explosives
(ANE)'' is insensitive enough for inclusion as an oxidizing liquid
(See B.13) or an oxidizing solid (See B.14) is determined by Test
Series 8 tests.
Note 1: Classification of solid chemicals shall be based on
tests performed on the chemical as presented. If, for example, for
the purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
Note 2: Some explosive chemicals are wetted with water or
alcohols, diluted with other substances or dissolved or suspended in
water or other liquid substances to suppress or reduce their
explosive properties. These chemicals shall be classified as
desensitized explosives (see Chapter B.17).
Note 3: Chemicals with a positive result in Test Series 2 in
Part I, Section 12, of UN ST/SG/AC.10/30/Rev.6 (UN Recommendations
on the Transport of Dangerous Goods, Manual of Tests and Criteria)
(incorporated by reference; see Sec. 1910.6) UN ST/SG/AC.10/30/
Rev.6 (UN Recommendations on the Transport of Dangerous Goods,
Manual of Tests and Criteria) (incorporated by reference; see Sec.
1910.6)), still have explosive properties. The explosive properties
of the chemical shall be communicated in Section 2 (Hazard
identification) and Section 9 (Physical and chemical properties) of
the Safety Data Sheet, as appropriate.
B.1.3.2 Explosive properties are associated with the presence of
certain chemical groups in a molecule which can react to produce
very rapid increases in temperature or pressure. The screening
procedure in B.1.3.1 is aimed at identifying the presence of such
reactive groups and the potential for rapid energy release. If the
screening procedure identifies the chemical as a potential
explosive, the acceptance procedure (See section 10.3 of the UN ST/
SG/AC.10 (incorporated by reference; See Sec. 1910.6)) is necessary
for classification.
Note: Neither a Series 1 type (a) propagation of detonation test
nor a Series 2 type (a) test of sensitivity to detonative shock is
necessary if the exothermic decomposition energy of organic
materials is less than 800 J/g.
B.1.3.3 If a mixture contains any known explosives, the
acceptance procedure is necessary for classification.
B.1.3.4 A chemical is not classified as explosive if:
(a) There are no chemical groups associated with explosive
properties present in the molecule. Examples of groups which may
indicate explosive properties are given in Table A6.1 in Appendix 6
of the UN ST/SG/AC.10 (incorporated by reference; See Sec. 1910.6);
or
(b) The substance contains chemical groups associated with
explosive properties which include oxygen and the calculated oxygen
balance is less than -200.
The oxygen balance is calculated for the chemical reaction:
CxHyOz + [x + (y/4)-(z/2)] O2
[rarr] x. CO2 + (y/2) H2O
using the formula:
oxygen balance = -1600 [2x + (y/2) -z]/molecular weight; or
(c) The organic substance or a homogenous mixture of organic
substances contains chemical groups associated with explosive
properties but the exothermic decomposition energy is less than 500
J/g and the onset of exothermic decomposition is below 500 [deg]C
(932 [deg]F). The exothermic decomposition energy may be determined
using a suitable calorimetric technique; or
(d) For mixtures of inorganic oxidizing substances with organic
material(s), the concentration of the inorganic oxidizing substance
is:
(i) Less than 15%, by mass, if the oxidizing substance is
assigned to Category 1 or 2;
(ii) less than 30%, by mass, if the oxidizing substance is
assigned to Category 3.
B.2 Flammable Gases
B.2.1 Definition
Flammable gas means a gas having a flammable range with air at
20 [deg]C (68 [deg]F) and a standard pressure of 101.3 kPa (14.7
psi).
A pyrophoric gas means a flammable gas that is liable to ignite
spontaneously in air at a temperature of 54 [deg]C (130 [deg]F) or
below.
A chemically unstable gas means a flammable gas that is able to
react explosively even in the absence of air or oxygen.
B.2.2 Classification Criteria
B.2.2.1 A flammable gas shall be classified in Category 1A, 1B,
or 2 in accordance with Table B.2.1:
[[Page 9758]]
[GRAPHIC] [TIFF OMITTED] TP16FE21.078
B.2.3 Additional Classification Considerations
B.2.3.1 Flammability shall be determined by tests or by
calculation in accordance with ISO 10156 (Gases and Gas Mixtures--
Determination of Fire Potential and Oxidizing Ability for the
Selection of Cylinder Valve Outlets; 1996, first edition or 2010,
third edition) (incorporated by reference; see Sec. 1910.6) and, if
using fundamental burning velocity for Category 1B, use ISO 817:2014
(third edition) (Refrigerants--Designation and safety
classification, Annex C: Method of test for burning velocity
measurement of flammable gases) (incorporated by reference; see
Sec. 1910.6). Where insufficient data are available to use this
method, equivalent validated methods may be used.
B.2.3.2 Pyrophoricity shall be determined at 130 [deg]F (54
[deg]C) in accordance with either IEC 60079-20-1, edition 1.0 (2010-
01) (Explosive atmospheres--Part 20-1: Material characteristics for
gas and vapor classification--Test methods and data) (incorporated
by reference; see Sec. 1910.6) or DIN 51794 (2003) (Determining the
ignition temperature of petroleum products) (incorporated by
reference; see Sec. 1910.6).
B.2.3.3 The classification procedure for pyrophoric gases need
not be applied when experience in production or handling shows that
the substance does not ignite spontaneously on coming into contact
with air at a temperature of 130 [deg]F (54 [deg]C) or below.
Flammable gas mixtures which have not been tested for pyrophoricity
and which contain more than one percent pyrophoric components shall
be classified as a pyrophoric gas. Expert judgement on the
properties and physical hazards of pyrophoric gases and their
mixtures should be used in assessing the need for classification of
flammable gas mixtures containing one percent or less pyrophoric
components. In this case, testing need only be considered if expert
judgement indicates a need for additional data to support the
classification process.
B.2.3.4 Chemical instability shall be determined in accordance
with the method described in Part III of the UN ST/SG/AC.10/30/Rev.6
(UN Recommendations on the Transport of Dangerous Goods, Manual of
Tests and Criteria) (incorporated by reference; see Sec. 1910.6)].
If the calculations performed in accordance with ISO 10156 (Gases
and Gas Mixtures--Determination of Fire Potential and Oxidizing
Ability for the Selection of Cylinder Valve Outlets; 1996, first
edition or 2010, third edition) (incorporated by reference; see
Sec. 1910.6) show that a gas mixture is not flammable, no
additional testing is required for determining chemical instability
for classification purposes.
B.3 Aerosols
B.3.1 Definition
Aerosol means any non-refillable receptacle containing a gas
compressed, liquefied or dissolved under pressure, and fitted with a
release device allowing the contents to be ejected as particles in
suspension in a gas, or as a foam, paste, powder, liquid or gas.
B.3.2 Classification Criteria
B.3.2.1 Aerosols are classified in one of three categories,
depending on their flammable properties and their heat of
combustion. Aerosols shall be considered for classification in
Categories 1 or 2 if they contain more than 1% components (by mass)
which are classified as flammable in accordance with this appendix,
i.e.:
Flammable gases (See B.2);
Flammable liquids (See B.6);
Flammable solids (See B.7);
or if their heat of combustion is at least 20 kJ/g.
Note 1: Flammable components do not include pyrophoric, self-
heating or water-reactive chemicals.
[[Page 9759]]
Note 2: Aerosols do not fall additionally within the scope of
flammable gases, gases under pressure, flammable liquids, or
flammable solids. However, depending on their contents, aerosols may
fall within the scope of other hazard classes.
B.3.2.2 An aerosol shall be classified in one of the three
categories for this class in accordance with Table B.3.1.
Table B.3.1--Criteria for Aerosols
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ Contains >=85% flammable components and the
chemical heat of combustion is >=30 kJ/g; or
(a) For spray aerosols, in the ignition
distance test, ignition occurs at a distance
>=75 cm (29.5 in), or
(b) For foam aerosols, in the aerosol foam
flammability test
(i) The flame height is >=20 cm (7.87 in) and
the flame duration >=2 s; or
(ii) The flame height is >=4 cm (1.57 in) and
the flame duration >=7 s.
2........................ Contains >1% flammable components, or the
heat of combustion is >=20 kJ/g; and
(a) for spray aerosols, in the ignition
distance test, ignition occurs at a distance
>=15 cm (5.9 in), or in the enclosed space
ignition test, the
(i) Time equivalent is <=300 s/m3; or
(ii) Deflagration density is <=300 g/m3
(b) For foam aerosols, in the aerosol foam
flammability test, the flame height is >=4
cm and the flame duration is >=2 s and it
does not meet the criteria for Category 1.
3........................ The chemical does not meet the criteria for
Categories 1 and 2. The chemical contains
<=1% flammable components (by mass) and has
a heat of combustion <20 kJ/g.
------------------------------------------------------------------------
Note: Aerosols containing more than 1% flammable components or
with a heat of combustion of at least 20 kJ/g, which are not
submitted to the flammability classification procedures in this
appendix shall be classified as Category 1.
B.3.3 Additional Classification Considerations
B.3.3.1 To classify an aerosol, data on its flammable
components, on its chemical heat of combustion and, if applicable,
the results of the aerosol foam flammability test (for foam
aerosols) and of the ignition distance test and enclosed space test
(for spray aerosols) are necessary.
B.3.3.2 The chemical heat of combustion ([Delta]Hc), in
kilojoules per gram (kJ/g), is the product of the theoretical heat
of combustion ([Delta]Hcomb), and a combustion efficiency, usually
less than 1.0 (a typical combustion efficiency is 0.95 or 95%).
For a composite aerosol formulation, the chemical heat of
combustion is the summation of the weighted heats of combustion for
the individual components, as follows:
[GRAPHIC] [TIFF OMITTED] TP16FE21.089
where:
[Delta]Hc = chemical heat of combustion (kJ/g);
wi% = mass fraction of component i in the product;
[Delta]Hc(i) = specific heat of combustion (kJ/g) of component i in
the product;
The chemical heats of combustion shall be found in literature,
calculated or determined by tests (See ASTM D240-02; ISO 13943,
Sections 86.1 to 86.3; and NFPA 30B (incorporated by reference; See
Sec. 1910.6)).
B.3.3.3 The Ignition Distance Test, Enclosed Space Ignition Test
and Aerosol Foam Flammability Test shall be performed in accordance
with sub-sections 31.4, 31.5 and 31.6 of the of the UN ST/SG/AC.10
(incorporated by reference; See Sec. 1910.6).
B.4 Oxidizing Gases
B.4.1 Definition
Oxidizing gas means any gas which may, generally by providing
oxygen, cause or contribute to the combustion of other material more
than air does.
Note: ``Gases which cause or contribute to the combustion of
other material more than air does'' means pure gases or gas mixtures
with an oxidizing power greater than 23.5% (as determined by a
method specified in ISO 10156 (Gases and Gas Mixtures--Determination
of Fire Potential and Oxidizing Ability for the Selection of
Cylinder Valve Outlets; 1996, first edition or 2010, third edition)
(incorporated by reference; see Sec. 1910.6) or 10156-2:2005 (E)
(Gas cylinders--Gases and Gas Mixtures--Part 2: Determination of
Oxidizing Ability of Toxic and Corrosive Gases and Gas Mixtures,
First Edition) (incorporated by reference; see Sec. 1910.6) or an
equivalent testing method).
B.4.2 Classification Criteria
An oxidizing gas shall be classified in a single category for
this class in accordance with Table B.4.1:
Table B.4.1--Criteria for Oxidizing Gases
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ Any gas which may, generally by providing
oxygen, cause or contribute to the
combustion of other material more than air
does.
------------------------------------------------------------------------
B.4.3 Additional Classification Considerations
Classification shall be in accordance with tests or calculation
methods as described in ISO 10156 (Gases and Gas Mixtures--
Determination of Fire Potential and Oxidizing Ability for the
Selection of Cylinder Valve Outlets; 1996, first edition or 2010,
third edition) (incorporated by reference; see Sec. 1910.6) and ISO
10156-2:2005 (E) (Gas cylinders--Gases and Gas Mixtures--Part 2:
Determination of Oxidizing Ability of Toxic and Corrosive Gases and
Gas Mixtures, First Edition) (incorporated by reference; see Sec.
1910.6).
B.5 Gases Under Pressure
B.5.1 Definition
Gases under pressure are gases which are contained in a
receptacle at a pressure of 200 kPa (29 psi) (gauge) or more at 20
[deg]C (68 [deg]F), or which are liquefied or liquefied and
refrigerated.
[[Page 9760]]
They comprise compressed gases, liquefied gases, dissolved gases
and refrigerated liquefied gases.
B.5.2 Classification Criteria
Gases under pressure shall be classified in one of four groups
in accordance with Table B.5.1:
Table B.5.1--Criteria for Gases Under Pressure
------------------------------------------------------------------------
Group Criteria
------------------------------------------------------------------------
Compressed gas............... A gas which when under pressure is
entirely gaseous at -50 [deg]C (-58
[deg]F), including all gases with a
critical temperature \1\ <=-50 [deg]C (-
58 [deg]F).
Liquefied gas................ A gas which when under pressure, is
partially liquid at temperatures above -
50 [deg]C (-58 [deg]F). A distinction is
made between:
(a) High pressure liquefied gas: A gas
with a critical temperature1 between
50 [deg]C (-58 [deg]F) and +65 [deg]C
(149 [deg]F); and
(b) Low pressure liquefied gas: A gas
with a critical temperature \1\ above
+65 [deg]C (149 [deg]F).
Refrigerated liquefied gas... A gas which is made partially liquid
because of its low temperature.
Dissolved gas................ A gas which when under pressure is
dissolved in a liquid phase solvent.
------------------------------------------------------------------------
\1\ The critical temperature is the temperature above which a pure gas
cannot be liquefied, regardless of the degree of compression.
Note: Aerosols should not be classified as gases under pressure. See
appendix B.3 of this section.
B.6 Flammable Liquids
B.6.1 Definition
Flammable liquid means a liquid having a flash point of not more
than 93 [deg]C (199.4 [deg]F).
Flash point means the minimum temperature at which a liquid
gives off vapor in sufficient concentration to form an ignitable
mixture with air near the surface of the liquid, as determined by a
method identified in Section B.6.3.
B.6.2 Classification Criteria
A flammable liquid shall be classified in one of four categories
in accordance with Table B.6.1:
Table B.6.1--Criteria for Flammable Liquids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ Flash point <23 [deg]C (73.4 [deg]F) and
initial boiling point <=35 [deg]C (95
[deg]F).
2........................ Flash point <23 [deg]C (73.4 [deg]F) and
initial boiling point >35 [deg]C (95
[deg]F).
3........................ Flash point >=23 [deg]C (73.4 [deg]F) and
<=60 [deg]C (140 [deg]F).
4........................ Flash point >60 [deg]C (140 [deg]F) and <=93
[deg]C (199.4 [deg]F).
------------------------------------------------------------------------
Note: Aerosols should not be classified as flammable liquids. See
appendix B.3 of this section.
B.6.3 Additional Classification Considerations
The flash point shall be determined in accordance with ASTM D56-
05, ASTM D3278, ASTM D3828, ASTM D93-08 (incorporated by reference;
See Sec. 1910.6), any method specified in 29 CFR 1910.106(a)(14),
or any other method specified in GHS Revision 7, Chapter 2.6.
The initial boiling point shall be determined in accordance with
ASTM D86-07a or ASTM D1078 (incorporated by reference; see Sec.
1910.6).\9\
---------------------------------------------------------------------------
\9\ To determine the appropriate flammable liquid storage
container size and type, the boiling point shall be determined by
methods specified under Sec. 1910.106(a)(5) and then listed on the
SDS. In addition, the manufacturer, importer, and distributor shall
clearly note in sections 7 and 9 of the SDS if an alternate
calculation was used for storage purposes.
---------------------------------------------------------------------------
B.7 Flammable Solids
B.7.1 Definitions
Flammable solid means a solid which is a readily combustible
solid, or which may cause or contribute to fire through friction.
Readily combustible solids are powdered, granular, or pasty
chemicals which are dangerous if they can be easily ignited by brief
contact with an ignition source, such as a burning match, and if the
flame spreads rapidly.
B.7.2 Classification Criteria
B.7.2.1 Powdered, granular or pasty chemicals shall be
classified as flammable solids when the time of burning of one or
more of the test runs, performed in accordance with the test method
described in the UN ST/SG/AC.10 (incorporated by reference; See
Sec. 1910.6), Part III, sub-section 33.2.1, is less than 45 s or
the rate of burning is more than 2.2 mm/s (0.0866 in/s).
B.7.2.2 Powders of metals or metal alloys shall be classified as
flammable solids when they can be ignited and the reaction spreads
over the whole length of the sample in 10 min or less.
B.7.2.3 Solids which may cause fire through friction shall be
classified in this class by analogy with existing entries (e.g.,
matches) until definitive criteria are established.
B.7.2.4 A flammable solid shall be classified in one of the two
categories for this class using Method N.1 as described in Part III,
sub-section 33.2.1 of the UN ST/SG/AC.10 (incorporated by reference;
See Sec. 1910.6), in accordance with Table B.7.1:
Table B.7.1--Criteria for Flammable Solids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ Burning rate test:
Chemicals other than metal powders:
(a) Wetted zone does not stop fire; and
(b) Burning time <45 s or burning rate
>2.2 mm/s.
Metal powders: Burning time <=5 min.
2........................ Burning rate test:
[[Page 9761]]
Chemicals other than metal powders:
(a) Wetted zone stops the fire for at
least 4 min; and
(b) Burning time <45 s or burning rate
>2.2 mm/s.
Metal powders: Burning time >5 min and <=10
min.
------------------------------------------------------------------------
Note 1: Classification of solid chemicals shall be based on
tests performed on the chemical as presented. If, for example, for
the purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
Note 2: Aerosols should not be classified as flammable solids.
See appendix B.3 of this section.
B.8 Self-Reactive Chemicals
B.8.1 Definitions
Self-reactive chemicals are thermally unstable liquid or solid
chemicals liable to undergo a strongly exothermic decomposition even
without participation of oxygen (air). This definition excludes
chemicals classified under this section as explosives, organic
peroxides, oxidizing liquids or oxidizing solids.
A self-reactive chemical is regarded as possessing explosive
properties when in laboratory testing the formulation is liable to
detonate, to deflagrate rapidly or to show a violent effect when
heated under confinement.
B.8.2 Classification Criteria
B.8.2.1 A self-reactive chemical shall be considered for
classification in this class unless:
(a) It is classified as an explosive according to B.1 of this
appendix;
(b) It is classified as an oxidizing liquid or an oxidizing
solid according to B.13 or B.14 of this appendix, except that a
mixture of oxidizing substances which contains 5% or more of
combustible organic substances shall be classified as a self-
reactive chemical according to the procedure defined in B.8.2.2;
(c) It is classified as an organic peroxide according to B.15 of
this appendix;
(d) Its heat of decomposition is less than 300 J/g; or
(e) Its self-accelerating decomposition temperature (SADT) is
greater than 75 [deg]C (167 [deg]F) for a 50 kg (110 lb) package.
B.8.2.2 Mixtures of oxidizing substances, meeting the criteria
for classification as oxidizing liquids or oxidizing solids, which
contain 5% or more of combustible organic substances and which do
not meet the criteria mentioned in B.8.2.1(a), (c), (d) or (e),
shall be subjected to the self-reactive chemicals classification
procedure in B.8.2.3. Such a mixture showing the properties of a
self-reactive chemical type B to F shall be classified as a self-
reactive chemical.
B.8.2.3 Self-reactive chemicals shall be classified in one of
the seven categories of ``types A to G'' for this class, according
to the following principles:
(a) Any self-reactive chemical which can detonate or deflagrate
rapidly, as packaged, will be defined as self-reactive chemical TYPE
A;
(b) Any self-reactive chemical possessing explosive properties
and which, as packaged, neither detonates nor deflagrates rapidly,
but is liable to undergo a thermal explosion in that package will be
defined as self-reactive chemical TYPE B;
(c) Any self-reactive chemical possessing explosive properties
when the chemical as packaged cannot detonate or deflagrate rapidly
or undergo a thermal explosion will be defined as self-reactive
chemical TYPE C;
(d) Any self-reactive chemical which in laboratory testing meets
the criteria in (d)(i), (ii), or (iii) will be defined as self-
reactive chemical TYPE D:
(i) Detonates partially, does not deflagrate rapidly and shows
no violent effect when heated under confinement; or
(ii) Does not detonate at all, deflagrates slowly and shows no
violent effect when heated under confinement; or
(iii) Does not detonate or deflagrate at all and shows a medium
effect when heated under confinement;
(e) Any self-reactive chemical which, in laboratory testing,
neither detonates nor deflagrates at all and shows low or no effect
when heated under confinement will be defined as self-reactive
chemical TYPE E;
(f) Any self-reactive chemical which, in laboratory testing,
neither detonates in the cavitated state nor deflagrates at all and
shows only a low or no effect when heated under confinement as well
as low or no explosive power will be defined as self-reactive
chemical TYPE F;
(g) Any self-reactive chemical which, in laboratory testing,
neither detonates in the cavitated state nor deflagrates at all and
shows no effect when heated under confinement nor any explosive
power, provided that it is thermally stable (self-accelerating
decomposition temperature is 60 [deg]C (140 [deg]F) to 75 [deg]C
(167 [deg]F) for a 50 kg (110 lb) package), and, for liquid
mixtures, a diluent having a boiling point greater than or equal to
150 [deg]C (302 [deg]F) is used for desensitization will be defined
as self-reactive chemical TYPE G. If the mixture is not thermally
stable or a diluent having a boiling point less than 150 [deg]C (302
[deg]F) is used for desensitization, the mixture shall be defined as
self-reactive chemical TYPE F.
B.8.3 Additional Classification Considerations
B.8.3.1 For purposes of classification, the properties of self-
reactive chemicals shall be determined in accordance with test
series A to H as described in Part II of the UN ST/SG/AC.10
(incorporated by reference; See Sec. 1910.6).
B.8.3.2 Self-accelerating decomposition temperature (SADT) shall
be determined in accordance with the UN ST/SG/AC.10, Part II,
section 28 (incorporated by reference; See Sec. 1910.6).
B.8.3.3 The classification procedures for self-reactive
substances and mixtures need not be applied if:
(a) There are no chemical groups present in the molecule
associated with explosive or self-reactive properties; examples of
such groups are given in Tables A6.1 and A6.2 in the Appendix 6 of
the UN ST/SG/AC.10 (incorporated by reference; See Sec. 1910.6); or
(b) For a single organic substance or a homogeneous mixture of
organic substances, the estimated SADT is greater than 75 [deg]C
(167 [deg]F) or the exothermic decomposition energy is less than 300
J/g. The onset temperature and decomposition energy may be estimated
using a suitable calorimetric technique (See 20.3.3.3 in Part II of
the UN ST/SG/AC.10 (incorporated by reference; See Sec. 1910.6)).
B.9 Pyrophoric Liquids
B.9.1 Definition
Pyrophoric liquid means a liquid which, even in small
quantities, is liable to ignite within five minutes after coming
into contact with air.
B.9.2 Classification Criteria
A pyrophoric liquid shall be classified in a single category for
this class using test N.3 in Part III, sub-section 33.3.1.5 of the
UN ST/SG/AC.10 (incorporated by reference; See Sec. 1910.6), in
accordance with Table B.9.1:
Table B.9.1--Criteria for Pyrophoric Liquids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ The liquid ignites within 5 min when added to
an inert carrier and exposed to air, or it
ignites or chars a filter paper on contact
with air within 5 min.
------------------------------------------------------------------------
[[Page 9762]]
B.9.3 Additional Classification Considerations
The classification procedure for pyrophoric liquids need not be
applied when experience in production or handling shows that the
chemical does not ignite spontaneously on coming into contact with
air at normal temperatures (i.e., the substance is known to be
stable at room temperature for prolonged periods of time (days)).
B.10 Pyrophoric Solids
B.10.1 Definition
Pyrophoric solid means a solid which, even in small quantities,
is liable to ignite within five minutes after coming into contact
with air.
B.10.2 Classification Criteria
A pyrophoric solid shall be classified in a single category for
this class using test N.2 in Part III, sub-section 33.3.1.4 of the
UN ST/SG/AC.10 (incorporated by reference; See Sec. 1910.6), in
accordance with Table B.10.1:
Table B.10.1--Criteria for Pyrophoric Solids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ The solid ignites within 5 min of coming into
contact with air.
------------------------------------------------------------------------
Note: Classification of solid chemicals shall be based on tests
performed on the chemical as presented. If, for example, for the
purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.10.3 Additional Classification Considerations
The classification procedure for pyrophoric solids need not be
applied when experience in production or handling shows that the
chemical does not ignite spontaneously on coming into contact with
air at normal temperatures (i.e., the chemical is known to be stable
at room temperature for prolonged periods of time (days)).
B.11 SELF-Heating Chemicals
B.11.1 Definition
A self-heating chemical is a solid or liquid chemical, other
than a pyrophoric liquid or solid, which, by reaction with air and
without energy supply, is liable to self-heat; this chemical differs
from a pyrophoric liquid or solid in that it will ignite only when
in large amounts (kilograms) and after long periods of time (hours
or days).
Note: Self-heating of a substance or mixture is a process where
the gradual reaction of that substance or mixture with oxygen (in
air) generates heat. If the rate of heat production exceeds the rate
of heat loss, then the temperature of the substance or mixture will
rise which, after an induction time, may lead to self-ignition and
combustion.
B.11.2 Classification Criteria
B.11.2.1 A self-heating chemical shall be classified in one of
the two categories for this class if, in tests performed in
accordance with test method N.4 in Part III, sub-section 33.3.1.6 of
the UN ST/SG/AC.10 (incorporated by reference; See Sec. 1910.6),
the result meets the criteria shown in Table B.11.1.
Table B.11.1--Criteria for Self-Heating Chemicals
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ A positive result is obtained in a test using
a 25 mm sample cube at 140 [deg]C (284
[deg]F).
2........................ A negative result is obtained in a test using
a 25 mm cube sample at 140 [deg]C (284
[deg]F), a positive result is obtained in a
test using a 100 mm sample cube at 140
[deg]C (284 [deg]F), and:
(a) The unit volume of the chemical is more
than 3 m\3\; or
(b) A positive result is obtained in a test
using a 100 mm cube sample at 120 [deg]C
(248 [deg]F) and the unit volume of the
chemical is more than 450 liters; or
(c) A positive result is obtained in a test
using a 100 mm cube sample at 100 [deg]C
(212 [deg]F).
------------------------------------------------------------------------
Note: Classification of solid chemicals shall be based on tests
performed on the chemical as presented. If, for example, for the
purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.11.2.2 Chemicals with a temperature of spontaneous combustion
higher than 50[deg]C (122 [deg]F) for a volume of 27 m3 shall not be
classified as self-heating chemicals.
B.11.2.3 Chemicals with a spontaneous ignition temperature
higher than 50 [deg]C (122 [deg]F) for a volume of 450 liters shall
not be classified in Category 1 of this class.
B.11.3 Additional Classification Considerations
B.11.3.1 The classification procedure for self-heating chemicals
need not be applied if the results of a screening test can be
adequately correlated with the classification test and an
appropriate safety margin is applied.
B.11.3.2 Examples of screening tests are:
(a) The Grewer Oven test (VDI guideline 2263, part 1, 1990, Test
methods for the Determination of the Safety Characteristics of
Dusts) with an onset temperature 80 [deg]K above the reference
temperature for a volume of 1 l;
(b) The Bulk Powder Screening Test (Gibson, N. Harper, D.J.
Rogers, R. Evaluation of the fire and explosion risks in drying
powders, Plant Operations Progress, 4 (3), 181-189, 1985) with an
onset temperature 60 [deg]K above the reference temperature for a
volume of 1 l.
B.12 Chemicals Which, in Contact With Water, Emit Flammable Gases
B.12.1 Definition
Chemicals which, in contact with water, emit flammable gases are
solid or liquid chemicals which, by interaction with water, are
liable to become spontaneously flammable or to give off flammable
gases in dangerous quantities.
B.12.2 Classification Criteria
B.12.2.1 A chemical which, in contact with water, emits
flammable gases shall be classified in one of the three categories
for this class, using test N.5 in Part III, sub-section 33.4.1.4 of
the UN ST/SG/AC.10 (incorporated by reference; See Sec. 1910.6), in
accordance with Table B.12.1:
[[Page 9763]]
Table B.12.1--Criteria for Chemicals Which, in Contact With Water, Emit
Flammable Gases
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ Any chemical which reacts vigorously with
water at ambient temperatures and
demonstrates generally a tendency for the
gas produced to ignite spontaneously, or
which reacts readily with water at ambient
temperatures such that the rate of evolution
of flammable gas is equal to or greater than
10 liters per kilogram of chemical over any
one minute.
2........................ Any chemical which reacts readily with water
at ambient temperatures such that the
maximum rate of evolution of flammable gas
is equal to or greater than 20 liters per
kilogram of chemical per hour, and which
does not meet the criteria for Category 1.
3........................ Any chemical which reacts slowly with water
at ambient temperatures such that the
maximum rate of evolution of flammable gas
is greater than 1 liter per kilogram of
chemical per hour, and which does not meet
the criteria for Categories 1 and 2.
------------------------------------------------------------------------
Note: Classification of solid chemicals shall be based on tests
performed on the chemical as presented. If, for example, for the
purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.12.2.2 A chemical is classified as a chemical which, in
contact with water, emits flammable gases if spontaneous ignition
takes place in any step of the test procedure.
B.12.3 Additional Classification Considerations
The classification procedure for this class need not be applied
if:
(a) The chemical structure of the chemical does not contain
metals or metalloids;
(b) Experience in production or handling shows that the chemical
does not react with water, (e.g., the chemical is manufactured with
water or washed with water); or
(c) The chemical is known to be soluble in water to form a
stable mixture.
B.13 Oxidizing Liquids
B.13.1 Definition
Oxidizing liquid means a liquid which, while in itself not
necessarily combustible, may, generally by yielding oxygen, cause,
or contribute to, the combustion of other material.
B.13.2 Classification Criteria
An oxidizing liquid shall be classified in one of the three
categories for this class using test O.2 in Part III, sub-section
34.4.2 of the UN ST/SG/AC.10 (incorporated by reference; See Sec.
1910.6), in accordance with Table B.13.1:
Table B.13.1--Criteria for Oxidizing Liquids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ Any chemical which, in the 1:1 mixture, by
mass, of chemical and cellulose tested,
spontaneously ignites; or the mean pressure
rise time of a 1:1 mixture, by mass, of
chemical and cellulose is less than that of
a 1:1 mixture, by mass, of 50% perchloric
acid and cellulose;
2........................ Any chemical which, in the 1:1 mixture, by
mass, of chemical and cellulose tested,
exhibits a mean pressure rise time less than
or equal to the mean pressure rise time of a
1:1 mixture, by mass, of 40% aqueous sodium
chlorate solution and cellulose; and the
criteria for Category 1 are not met;
3........................ Any chemical which, in the 1:1 mixture, by
mass, of chemical and cellulose tested,
exhibits a mean pressure rise time less than
or equal to the mean pressure rise time of a
1:1 mixture, by mass, of 65% aqueous nitric
acid and cellulose; and the criteria for
Categories 1 and 2 are not met.
------------------------------------------------------------------------
B.13.3 Additional Classification Considerations
B.13.3.1 For organic chemicals, the classification procedure for
this class shall not be applied if:
(a) The chemical does not contain oxygen, fluorine or chlorine;
or
(b) The chemical contains oxygen, fluorine or chlorine and these
elements are chemically bonded only to carbon or hydrogen.
B.13.3.2 For inorganic chemicals, the classification procedure
for this class shall not be applied if the chemical does not contain
oxygen or halogen atoms.
B.13.3.3 In the event of divergence between test results and
known experience in the handling and use of chemicals which shows
them to be oxidizing, judgments based on known experience shall take
precedence over test results.
B.13.3.4 In cases where chemicals generate a pressure rise (too
high or too low), caused by chemical reactions not characterizing
the oxidizing properties of the chemical, the test described in Part
III, sub-section 34.4.2 of the UN ST/SG/AC.10 (incorporated by
reference; See Sec. 1910.6) shall be repeated with an inert
substance (e.g., diatomite (kieselguhr)) in place of the cellulose
in order to clarify the nature of the reaction.
B.14 Oxidizing Solids
B.14.1 Definition
Oxidizing solid means a solid which, while in itself is not
necessarily combustible, may, generally by yielding oxygen, cause,
or contribute to, the combustion of other material.
B.14.2 Classification Criteria
An oxidizing solid shall be classified in one of the three
categories for this class using test O.1 in Part III, sub-section
34.4.1 or test O.3 in Part III, sub-section 34.4.3, of the UN ST/SG/
AC.10 (incorporated by reference; See Sec. 1910.6), in accordance
with Table B.14.1:
Table B.14.1--Criteria for Oxidizing Solids
------------------------------------------------------------------------
Criteria using test
Category Criteria using test O.1 O.3
------------------------------------------------------------------------
1...................... Any chemical which, in Any chemical which, in
the 4:1 or 1:1 sample- the 4:1 or 1:1 sample-
to-cellulose ratio (by to-cellulose ratio
mass) tested, exhibits (by mass) tested,
a mean burning time exhibits a mean
less than the mean burning rate greater
burning time of a 3:2 than the mean burning
mixture, (by mass), of rate of a 3:1 mixture
potassium bromate and (by mass) of calcium
cellulose. peroxide and
cellulose.
[[Page 9764]]
2...................... Any chemical which, in Any chemical which, in
the 4:1 or 1:1 sample- the 4:1 or 1:1 sample-
to-cellulose ratio (by to-cellulose ratio
mass) tested, exhibits (by mass) tested,
a mean burning time exhibits a mean
equal to or less than burning rate equal to
the mean burning time or greater than the
of a 2:3 mixture (by mean burning rate of
mass) of potassium a 1:1 mixture (by
bromate and cellulose mass) of calcium
and the criteria for peroxide and
Category 1 are not met. cellulose and the
criteria for Category
1 are not met.
3...................... Any chemical which, in Any chemical which, in
the 4:1 or 1:1 sample- the 4:1 or 1:1 sample-
to-cellulose ratio (by to-cellulose ratio
mass) tested, exhibits (by mass) tested,
a mean burning time exhibits a mean
equal to or less than burning rate equal to
the mean burning time or greater than the
of a 3:7 mixture (by mean burning rate of
mass) of potassium a 1:2 mixture (by
bromate and cellulose mass) of calcium
and the criteria for peroxide and
Categories 1 and 2 are cellulose and the
not met. criteria for
Categories 1 and 2
are not met.
------------------------------------------------------------------------
Note 1: Some oxidizing solids may present explosion hazards
under certain conditions (e.g., when stored in large quantities).
For example, some types of ammonium nitrate may give rise to an
explosion hazard under extreme conditions and the ``Resistance to
detonation test'' (International Maritime Solid Bulk Cargoes Code,
IMO (IMSBC), Appendix 2, Section 5) may be used to assess this
hazard. When information indicates that an oxidizing solid may
present an explosion hazard, it shall be indicated on the Safety
Data Sheet.
Note 2: Classification of solid chemicals shall be based on
tests performed on the chemical as presented. If, for example, for
the purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.14.3 Additional Classification Considerations
B.14.3.1 For organic chemicals, the classification procedure for
this class shall not be applied if:
(a) The chemical does not contain oxygen, fluorine or chlorine;
or
(b) The chemical contains oxygen, fluorine or chlorine and these
elements are chemically bonded only to carbon or hydrogen.
B.14.3.2 For inorganic chemicals, the classification procedure
for this class shall not be applied if the chemical does not contain
oxygen or halogen atoms.
B.14.3.3 In the event of divergence between test results and
known experience in the handling and use of chemicals which shows
them to be oxidizing, judgements based on known experience shall
take precedence over test results.
B.15 Organic Peroxides
B.15.1 Definition
B.15.1.1 Organic peroxide means a liquid or solid organic
chemical which contains the bivalent -0-0- structure and as such is
considered a derivative of hydrogen peroxide, where one or both of
the hydrogen atoms have been replaced by organic radicals. The term
organic peroxide includes organic peroxide mixtures containing at
least one organic peroxide. Organic peroxides are thermally unstable
chemicals, which may undergo exothermic self-accelerating
decomposition. In addition, they may have one or more of the
following properties:
(a) Be liable to explosive decomposition;
(b) Burn rapidly;
(c) Be sensitive to impact or friction;
(d) React dangerously with other substances.
B.15.1.2 An organic peroxide is regarded as possessing explosive
properties when in laboratory testing the formulation is liable to
detonate, to deflagrate rapidly or to show a violent effect when
heated under confinement.
B.15.2 Classification Criteria
B.15.2.1 Any organic peroxide shall be considered for
classification in this class, unless it contains:
(a) Not more than 1.0% available oxygen from the organic
peroxides when containing not more than 1.0% hydrogen peroxide; or
(b) Not more than 0.5% available oxygen from the organic
peroxides when containing more than 1.0% but not more than 7.0%
hydrogen peroxide.
Note: The available oxygen content (%) of an organic peroxide
mixture is given by the formula:
[GRAPHIC] [TIFF OMITTED] TP16FE21.090
where:
ni = number of peroxygen groups per molecule of organic
peroxide i;
ci = concentration (mass %) of organic peroxide i;
mi = molecular mass of organic peroxide i.
B.15.2.2 Organic peroxides shall be classified in one of the
seven categories of ``Types A to G'' for this class, according to
the following principles:
(a) Any organic peroxide which, as packaged, can detonate or
deflagrate rapidly shall be defined as organic peroxide TYPE A;
(b) Any organic peroxide possessing explosive properties and
which, as packaged, neither detonates nor deflagrates rapidly, but
is liable to undergo a thermal explosion in that package shall be
defined as organic peroxide TYPE B;
(c) Any organic peroxide possessing explosive properties when
the chemical as packaged cannot detonate or deflagrate rapidly or
undergo a thermal explosion shall be defined as organic peroxide
TYPE C;
(d) Any organic peroxide which in laboratory testing meets the
criteria in (d)(i), (ii), or (iii) shall be defined as organic
peroxide TYPE D:
(i) Detonates partially, does not deflagrate rapidly and shows
no violent effect when heated under confinement; or
(ii) Does not detonate at all, deflagrates slowly and shows no
violent effect when heated under confinement; or
(iii) Does not detonate or deflagrate at all and shows a medium
effect when heated under confinement;
(e) Any organic peroxide which, in laboratory testing, neither
detonates nor deflagrates at all and shows low or no effect when
heated under confinement shall be defined as organic peroxide TYPE
E;
(f) Any organic peroxide which, in laboratory testing, neither
detonates in the cavitated state nor deflagrates at all and shows
only a low or no effect when heated under confinement as well as low
or no explosive power shall be defined as organic peroxide TYPE F;
(g) Any organic peroxide which, in laboratory testing, neither
detonates in the cavitated state nor deflagrates at all and shows no
effect when heated under confinement nor any explosive power,
provided that it is thermally stable (self-accelerating
decomposition temperature is 60 [deg]C (140 [deg]F) or higher for a
50 kg (110 lb) package), and, for liquid mixtures, a diluent having
a boiling point of not less than 150 [deg]C (302 [deg]F) is used for
desensitization, shall be defined as organic peroxide TYPE G. If the
organic peroxide is not thermally stable or a diluent having a
boiling point less than 150 [deg]C (302 [deg]F) is used for
desensitization, it shall be defined as organic peroxide TYPE F.
B.15.3 Additional Classification Considerations
B.15.3.1 For purposes of classification, the properties of
organic peroxides shall be determined in accordance with test series
A to H as described in Part II of the UN ST/SG/AC.10 (incorporated
by reference; See Sec. 1910.6).
B.15.3.2 Self-accelerating decomposition temperature (SADT)
shall be determined in accordance with the UN ST/SG/AC.10
(incorporated by reference; See Sec. 1910.6), Part II, section 28.
B.15.3.3 Mixtures of organic peroxides may be classified as the
same type of organic peroxide as that of the most dangerous
ingredient. However, as two stable ingredients can form a thermally
less stable mixture, the SADT of the mixture shall be determined.
[[Page 9765]]
B.16 Corrosive to Metals
B.16.1 Definition
A chemical which is corrosive to metals means a chemical which
by chemical action will materially damage, or even destroy, metals.
B.16.2 Classification criteria
A chemical which is corrosive to metals shall be classified in a
single category for this class, using the test in Part III, sub-
section 37.4 of the UN ST/SG/AC.10 (incorporated by reference; See
Sec. 1910.6), in accordance with Table B.16.1:
Table B.16.1--Criteria for Chemicals Corrosive to Metal
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ Corrosion rate on either steel or aluminium
surfaces exceeding 6.25 mm per year at a
test temperature of 55 [deg]C (131 [deg]F)
when tested on both materials.
------------------------------------------------------------------------
Note: Where an initial test on either steel or aluminium
indicates the chemical being tested is corrosive the follow-up test
on the other metal is not necessary.
B.16.3 Additional Classification Considerations
The specimen to be used for the test shall be made of the
following materials:
(a) For the purposes of testing steel, steel types S235JR+CR
(1.0037 resp.St 37-2), S275J2G3+CR (1.0144 resp.St 44-3), ISO 3574,
Unified Numbering System (UNS) G 10200, or SAE 1020;
(b) For the purposes of testing aluminium: non-clad types 7075-
T6 or AZ5GU-T6.
Chapter B.17
Desensitized Explosives
B.17.1 Definitions and General Considerations
Desensitized explosives are solid or liquid explosive chemicals
which are phlegmatized \10\ to suppress their explosive properties
in such a manner that they do not mass explode and do not burn too
rapidly and therefore may be exempted from the hazard class
``Explosives'' (Chapter B.1; see also Note 2 of paragraph
B.1.3).\11\
---------------------------------------------------------------------------
\10\ Phlegmatized means that a substance (or ``phlegmatizer'')
has been added to an explosive to enhance its safety in handling and
transport. The phlegmatizer renders the explosive insensitive, or
less sensitive, to the following actions: Heat, shock, impact,
percussion or friction. Typical phlegmatizing agents include, but
are not limited to: Wax, paper, water, polymers (such as
chlorofluoropolymers), alcohol and oils (such as petroleum jelly and
paraffin). (As defined in Chapter 2.1 of UN ST/SG/AC.10/30/Rev.6 (UN
Recommendations on the Transport of Dangerous Goods, Manual of Test
Criteria) (incorporated by reference; see Sec. 1910.6)).
\11\ Unstable explosives as defined in Chapter B.1 can also be
stabilized by desensitization and consequently may be re-classified
as desensitized explosives, provided all criteria of Chapter B.17
are met. In this case, the desensitized explosive should be tested
according to Test Series 3 (Part I of UN ST/SG/AC.10/30/Rev. 6 (UN
Recommendations on the Transport of Dangerous Goods, Manual of Tests
and Criteria) (incorporated by reference; see Sec. 1910.6)) because
information about its sensitiveness to mechanical stimuli is likely
to be important for determining conditions for safe handling and
use. The results shall be communicated on the safety data sheet.
---------------------------------------------------------------------------
B.17.1.2 The class of desensitized explosives comprises:
(a) Solid desensitized explosives: Explosive substances or
mixtures which are wetted with water or alcohols or are diluted with
other substances, to form a homogeneous solid mixture to suppress
their explosive properties.
Note: This includes desensitization achieved by formation of
hydrates of the substances.
(b) Liquid desensitized explosives: Explosive substances or
mixtures which are dissolved or suspended in water or other liquid
substances, to form a homogeneous liquid mixture to suppress their
explosive properties.
B.17.2 Classification Criteria
B.2.17.2.1 Any explosive which is desensitized shall be
considered in this class, unless:
(a) It is intended to produce a practical, explosive or
pyrotechnic effect; or
(b) It has a mass explosion hazard according to test series 6(a)
or 6(b) or its corrected burning rate according to the burning rate
test described in part V, subsection 51.4 of UN ST/SG/AC.10/30/Rev.6
(UN Recommendations on the Transport of Dangerous Goods, Manual of
Tests and Criteria) (incorporated by reference; see Sec. 1910.6) is
greater than 1200 kg/min; or
(c) Its exothermic decomposition energy is less than 300 J/g.
Note 1: Substances or mixtures which meet the criterion (a) or
(b) shall be classified as explosives (see Chapter B.1). Substances
or mixtures which meet the criterion (c) may fall within the scope
of other physical hazard classes.
Note 2: The exothermic decomposition energy may be estimated
using a suitable calorimetric technique (see section 20, sub-section
20.3.3.3 in Part II of UN ST/SG/AC.10/30/Rev.6 (UN Recommendations
on the Transport of Dangerous Goods, Manual of Tests and Criteria)
(incorporated by reference; see Sec. 1910.6).
B.17.2.2 Desensitized explosives shall be classified in one of
the four categories of this class depending on the corrected burning
rate (Ac) using the test ``burning rate test (external fire)''
described in Part V, sub-section 51.4 of UN ST/SG/AC.10/30/Rev.6 (UN
Recommendations of the Transport of Dangerous Goods, Manual of Tests
and Criteria) (incorporated by reference; see Sec. 1910.6),
according to Table B.17.1:
Table B.17.1 Criteria for Desensitized Explosives
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1........................ Desensitized explosives with a corrected
burning rate (AC) equal to or greater than
300 kg/min but not more than 1200 kg/min.
2........................ Desensitized explosives with a corrected
burning rate (AC) equal to or greater than
140 kg/min but less than 300 kg/min.
3........................ Desensitized explosives with a corrected
burning rate (AC) equal to or greater than
60 kg/min but less than 140 kg/min.
4........................ Desensitized explosives with a corrected
burning rate (AC) less than 60 kg/min.
------------------------------------------------------------------------
Note 1: Desensitized explosives shall be prepared so that they
remain homogeneous and do not separate during normal storage and
handling, particularly if desensitized by wetting. The manufacturer,
importer, or distributor shall provide information in Section 10 of
the safety data sheet about the shelf-life and instructions on
verifying desensitization. Under certain conditions the content of
desensitizing agent (e.g., phlegmatizer, wetting agent or treatment)
may decrease during supply and use, and thus, the hazard potential
of the desensitized explosive may increase. In addition, Sections 5
and/or 8 of the safety data sheet shall include advice on avoiding
increased fire, blast or protection hazards when the chemical is not
sufficiently desensitized.
Note 2: Explosive properties of desensitized explosives shall be
determined using data from Test Series 2 of UN ST/SG/
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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
Sec. 1910.6) and shall be communicated in the safety data sheet.
For testing of liquid desensitized explosives, refer to section 32,
sub-section 32.3.2 of UN ST/SG/AC.10/30/Rev.6 (UN Recommendations on
the Transport of Dangerous Goods, Manual of Tests and Criteria)
(incorporated by reference; see Sec. 1910.6). Testing of solid
desensitized explosives is addressed in section 33, sub-section
33.2.3 of UN ST/SG/AC.10/30/Rev.6 (UN Recommendations on the
Transport of Dangerous Goods, Manual of Tests and Criteria)
(incorporated by reference; see Sec. 1910.6).
Note 3: Desensitized explosives do not fall additionally within
the scope of chapters B.1 (explosives), B.6 (flammable liquids) and
B.7 (flammable solids).
B.17.3 Additional Classification Considerations
B.17.3.1 The classification procedure for desensitized
explosives does not apply if:
(a) The substances or mixtures contain no explosives according
to the criteria in Chapter B.1; or
(b) The exothermic decomposition energy is less than 300 J/g.
B.17.3.2 The exothermic decomposition energy shall be determined
using the explosive already desensitized (i.e., the homogenous solid
or liquids mixture formed by the explosive and the substance(s) used
to suppress its explosive properties). The exothermic decomposition
energy may be estimated using a suitable calorimetric technique (see
Section 20, sub-section 20.3.3.3 in Part II of UN ST/SG/AC.10/30/
Rev. 6 (UN Recommendations on the Transport of Dangerous Goods,
Manual of Tests and Criteria) (incorporated by reference; see Sec.
1910.6).
Appendix C to Sec. 1910.1200--Allocation of Label Elements (Mandatory)
C.1 The label for each hazardous chemical shall include the
product identifier used on the safety data sheet.
C.1.1 The labels on shipped containers shall also include the
name, address, and telephone number of the chemical manufacturer,
importer, or responsible party.
C.2 The label for each hazardous chemical that is classified
shall include the signal word, hazard statement(s), pictogram(s),
and precautionary statement(s) specified in C.4 for each hazard
class and associated hazard category, except as provided for in
C.2.1 through C.2.4.
C.2.1 Precedence of hazard information
C.2.1.1 If the signal word ``Danger'' is included, the signal
word ``Warning'' shall not appear;
C.2.1.2 If the skull and crossbones pictogram is included, the
exclamation mark pictogram shall not appear where it is used for
acute toxicity;
C.2.1.3 If the corrosive pictogram is included, the exclamation
mark pictogram shall not appear where it is used for skin or eye
irritation;
C.2.1.4 If the health hazard pictogram is included for
respiratory sensitization, the exclamation mark pictogram shall not
appear where it is used for skin sensitization or for skin or eye
irritation.
C.2.2 Hazard statement text
C.2.2.1 The text of all applicable hazard statements shall
appear on the label, except as otherwise specified. The information
in italics shall be included as part of the hazard statement as
provided. For example: ``Causes damage to organs (state all organs
affected) through prolonged or repeated exposure (state route of
exposure if no other routes of exposure cause the hazard)''. Hazard
statements may be combined where appropriate to reduce the
information on the label and improve readability, as long as all of
the hazards are conveyed as required.
C.2.2.2 If the chemical manufacturer, importer, or responsible
party can demonstrate that all or part of the hazard statement is
inappropriate to a specific substance or mixture, the corresponding
statement may be omitted from the label.
C.2.3 Pictograms
C.2.3.1 Pictograms shall be in the shape of a square set at a
point and shall include a black hazard symbol on a white background
with a red frame sufficiently wide to be clearly visible. A square
red frame set at a point without a hazard symbol is not a pictogram
and is not permitted on the label.
C.2.3.2 One of eight standard hazard symbols shall be used in
each pictogram. The eight hazard symbols are depicted in Figure C.1.
A pictogram using the exclamation mark symbol is presented in Figure
C.2, for the purpose of illustration.
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C.2.3.3 The exclamation mark pictogram is permitted (but not
required) for HNOCs as long as the words ``Hazard Not Otherwise
Classified'' or the letters ``HNOC'' appear below the pictogram.
C.2.3.4 Pictograms may only appear once on a label. If multiple
hazards require the use of the same pictogram, it may not appear a
second time on the label.
C.2.4 Precautionary statement text
C.2.4.1 There are four types of precautionary statements
presented, ``prevention,'' ``response,'' ``storage,'' and
``disposal.'' The core part of the precautionary statement is
presented in bold print. This is the text, except as otherwise
specified, that shall appear on the label. Where additional
information is required, it is indicated in plain text.
C.2.4.2 When a backslash or diagonal mark (/) appears in the
precautionary
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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 ventilation
wear respiratory protection.'' However, if the chemical is supplied
without such ventilation information, the text in square brackets
should not be used, and the precautionary statement should read:
``Wear respiratory protection.''
C.2.4.6 Precautionary statements may be combined or consolidated
to save label space and improve readability. For example, ``Keep
away from heat, sparks and open flame,'' ``Store in a well-
ventilated place'' and ``Keep cool'' can be combined to read ``Keep
away from heat, sparks and open flame and store in a cool, well-
ventilated place.''
C.2.4.7 Precautionary statements may incorporate minor textual
variations from the text prescribed in this appendix if these
variations assist in communicating safety information (e.g.,
spelling variations, synonyms or other equivalent terms) and the
safety advice is not diluted or compromised. Any variations must be
used consistently on the label and the safety data sheet.
C.2.4.8 In most cases, the precautionary statements are
independent (e.g., the phrases for explosive hazards do not modify
those related to certain health hazards, and products that are
classified for both hazard classes shall bear appropriate
precautionary statements for both). Where a chemical is classified
for a number of hazards, and the precautionary statements are
similar, the most stringent shall be included on the label (this
will be applicable mainly to preventive measures).
C.2.4.9 If the chemical manufacturer, importer, or responsible
party can demonstrate that a precautionary statement is
inappropriate to a specific substance or mixture, the precautionary
statement may be omitted from the label.
C.2.4.10 Where a substance or mixture is classified for a number
of health hazards, this may trigger multiple precautionary
statements relating to medical response, e.g., calling a poison
center/doctor/. . . and getting medical advice/attention.
In general, the following principles should be applied:
(a) Where the classification of a substance or mixture triggers
several different precautionary statements, a system of
prioritization should be applied. Usually, the label need only
include one precautionary statement reflecting the response at the
highest level with the greatest urgency, which should always be
combined with at least one route of exposure or symptom ``IF''
statement.
(b) Routes of exposure, including ``IF exposed or concerned,''
may be combined when triggered with a medical response statement. If
the response statement is triggered with three or more routes of
exposure, ``IF exposed or concerned'' may be used. However, relevant
``IF'' statements describing symptoms must be included in full. If a
route of exposure is triggered multiple times, it need only be
included once.
(c) This does not apply to ``Get medical advice/attention if you
feel unwell'' or ``Get immediate medical advice/attention'' when
they are combined with an ``If'' statement and should appear without
prioritization.
C.3 Supplementary hazard information
C.3.1 To ensure that non-standardized information does not lead
to unnecessarily wide variation or undermine the required
information, supplementary information on the label is limited to
when it provides further detail and does not contradict or cast
doubt on the validity of the standardized hazard information.
C.3.2 Where the chemical manufacturer, importer, or distributor
chooses to add supplementary information on the label, the placement
of supplemental information shall not impede identification of
information required by this section.
C.3.3 Where an ingredient with unknown acute toxicity is used in
a mixture at a concentration >=1%, and the mixture is not classified
based on testing of the mixture as a whole, a statement that X% of
the mixture consists of ingredient(s) of unknown acute toxicity
(oral/dermal/inhalation) is required on the label and safety data
sheet.
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BILLING CODE 4510-26-C
Appendix D to Sec. 1910.1200--Safety Data Sheets (Mandatory)
A safety data sheet (SDS) shall include the information
specified in Table D.1 under the section number and heading
indicated for sections 1-11 and 16. While each section of the SDS
must contain all of the specified information, preparers of safety
data sheets are not required to present the information in any
particular order within each section. If no relevant information is
found for any given subheading within a section, the SDS shall
clearly indicate that no applicable information is available.
Sections 12-15 may be included in the SDS, but are not mandatory.
Table D.1--Minimum Information for an SDS
------------------------------------------------------------------------
Heading Subheading
------------------------------------------------------------------------
1. Identification................. (a) Product identifier used on the
label;
(b) Other means of identification;
(c) Recommended use of the chemical
and restrictions on use;
(d) Name, U.S. address, and U.S.
telephone number of the chemical
manufacturer, importer, or other
responsible party;
(e) Emergency phone number.
2. Hazard(s) identification....... (a) Classification of the chemical
in accordance with paragraph (d) of
Sec. 1910.1200, including any
hazards associated with a change in
the chemical's physical form under
normal conditions of use;
(b) Signal word, hazard
statement(s), symbol(s) and
precautionary statement(s) in
accordance with paragraph (f) of
Sec. 1910.1200. (Hazard symbols
may be provided as graphical
reproductions in black and white or
the name of the symbol, e.g.,
flame, skull and crossbones);
(c) Hazards identified under normal
conditions of use that result from
a chemical reaction (changing the
chemical structure of the original
substance or mixture);
(d) Describe any hazards not
otherwise classified that have been
identified during the
classification process;
(e) Where an ingredient with unknown
acute toxicity is used in a mixture
at a concentration >=1% and the
mixture is not classified based on
testing of the mixture as a whole,
a statement that X% of the mixture
consists of ingredient(s) of
unknown acute toxicity is required.
3. Composition/information on Except as provided for in paragraph
ingredients. (i) of Sec. 1910.1200 on trade
secrets:
For Substances
(a) Chemical name;
(b) Common name and synonyms;
(c) CAS number and other unique
identifiers;
(d) Impurities and stabilizing
additives (constituents) which are
themselves classified and which
contribute to the classification of
the substance.
For Mixtures
In addition to the information
required for substances:
(a) The chemical name, CAS number or
other unique identifier, and
concentration (exact percentage) or
concentration ranges of all
ingredients which are classified as
health hazards in accordance with
paragraph (d) of Sec. 1910.1200
and
(1) are present above their cut-off/
concentration limits; or
(2) present a health risk below the
cut-off/concentration limits.
(b) The concentration (exact
percentage) shall be specified
unless a trade secret claim is made
in accordance with paragraph (i) of
Sec. 1910.1200, when there is
batch-to-batch variability in the
production of a mixture, or for a
group of substantially similar
mixtures (See A.0.5.1.2) with
similar chemical composition. In
these cases, concentration ranges
may be used.
For All Chemicals Where a Trade
Secret is Claimed
Where a trade secret is claimed in
accordance with paragraph (i) of
Sec. 1910.1200, a statement that
the specific chemical identity,
exact percentage (concentration),
or concentration range of
composition has been withheld as a
trade secret is required. When the
concentration or concentration
range is withheld as a trade
secret, the chemical composition
must be provided in accordance with
the prescribed concentration ranges
in Sec. 1910.1200(i)(1)(iv).
4. First-aid measures............. (a) Description of necessary
measures, subdivided according to
the different routes of exposure,
i.e., inhalation, skin and eye
contact, and ingestion;
(b) Most important symptoms/effects,
acute and delayed.
(c) Indication of immediate medical
attention and special treatment
needed, if necessary.
5. Fire-fighting measures......... (a) Suitable (and unsuitable)
extinguishing media.
(b) Specific hazards arising from
the chemical (e.g., nature of any
hazardous combustion products).
(c) Special protective equipment and
precautions for fire-fighters.
6. Accidental release measures.... (a) Personal precautions, protective
equipment, and emergency
procedures.
(b) Methods and materials for
containment and cleaning up.
7. Handling and storage........... (a) Precautions for safe handling.
(b) Conditions for safe storage,
including any incompatibilities.
8. Exposure controls/personal (a) For all ingredients or
protection. constituents listed in Section 3,
the OSHA permissible exposure limit
(PEL), American Conference of
Governmental Industrial Hygienists
(ACGIH) Threshold Limit Value
(TLV), and any other exposure limit
or range used or recommended by the
chemical manufacturer, importer, or
employer preparing the safety data
sheet, where available.
(b) Appropriate engineering
controls.
(c) Individual protection measures,
such as personal protective
equipment.
9. Physical and chemical (a) Physical state.
properties.
(b) Color.
(c) Odor.
(d) Melting point/freezing point.
(e) Boiling point (or initial
boiling point or boiling range).
(f) Flammability.
[[Page 9831]]
(g) Lower and upper explosion limit/
flammability limit.
(h) Flash point.
(i) Auto-ignition temperature.
(j) Decomposition temperature.
(k) pH.
(l) Kinematic viscosity.
(m) Solubility.
(n) Partition coefficient n-octanol/
water (log value).
(o) Vapor pressure.
(p) Density and/or relative density.
(q) Relative vapor density.
(r) Particle characteristics.
10. Stability and reactivity...... (a) Reactivity;
(b) Chemical stability;
(c) Possibility of hazardous
reactions, including those
associated with foreseeable
emergencies;
(d) Conditions to avoid (e.g.,
static discharge, shock, or
vibration);
(e) Incompatible materials;
(f) Hazardous decomposition
products.
11. Toxicological information..... Description of the various
toxicological (health) effects and
the available data used to identify
those effects, including:
(a) Information on the likely routes
of exposure (inhalation, ingestion,
skin and eye contact);
(b) Symptoms related to the
physical, chemical and
toxicological characteristics;
(c) Delayed and immediate effects
and also chronic effects from short-
and long-term exposure;
(d) Numerical measures of toxicity
(such as acute toxicity estimates);
(e) Interactive effects; information
on interactions should be included
if relevant and readily available;
(f) Whether the hazardous chemical
is listed in the National
Toxicology Program (NTP) Report on
Carcinogens (latest edition) or has
been found to be a potential
carcinogen in the International
Agency for Research on Cancer
(IARC) Monographs (latest edition),
or by OSHA.
(g) When specific chemical data or
information is not available, the
preparer must indicate if
alternative information is used and
the method used to derive the
information (e.g., where the
preparer is using information from
a class of chemicals rather than
the exact chemical in question and
using SAR to derive the
toxicological information).
12. Ecological information (Non- (a) Ecotoxicity (aquatic and
mandatory). terrestrial, where available);
(b) Persistence and degradability;
(c) Bioaccumulative potential;
(d) Mobility in soil;
(e) Other adverse effects (such as
hazardous to the ozone layer).
13. Disposal considerations (Non- Description of waste residues and
mandatory). information on their safe handling
and methods of disposal, including
the disposal of any contaminated
packaging.
14. Transport information (Non- (a) UN number;
mandatory).
(b) UN proper shipping name;
(c) Transport hazard class(es);
(d) Packing group, if applicable;
(e) Environmental hazards (e.g.,
Marine pollutant (Yes/No));
(f) Transport in bulk according to
IMO instruments;
(g) Special precautions which a user
needs to be aware of, or needs to
comply with, in connection with
transport or conveyance either
within or outside their premises.
15. Regulatory information (Non- Safety, health and environmental
mandatory). regulations specific for the
product in question.
16. Other information, including The date of preparation of the SDS
date of preparation or last or the last change to it.
revision.
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* * * * *
[FR Doc. 2020-28987 Filed 2-5-21; 8:45 am]
BILLING CODE 4510-26-P