Hazard Communication, 50280-50549 [E9-22483]
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Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Proposed Rules
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Parts 1910, 1915, and 1926
[Docket No. OSHA–H022K–2006–0062
(formerly Docket No. H022K)]
RIN 1218–AC20
Hazard Communication
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AGENCY: Occupational Safety and Health
Administration (OSHA), Department of
Labor.
ACTION: Proposed rule; request for
comments.
SUMMARY: OSHA is proposing to modify
its existing Hazard Communication
Standard (HCS) to conform with the
United Nations’ (UN) Globally
Harmonized System of Classification
and Labelling of Chemicals (GHS).
OSHA has made a preliminary
determination that the proposed
modifications will improve the quality
and consistency of information
provided to employers and employees
regarding chemical hazards and
associated protective measures. The
Agency anticipates this improved
information will enhance the
effectiveness of the HCS in ensuring that
employees are apprised of the chemical
hazards to which they may be exposed,
and in reducing the incidence of
chemical-related occupational illnesses
and injuries.
The proposed modifications to the
standard include revised criteria for
classification of chemical hazards;
revised labeling provisions that include
requirements for use of standardized
signal words, pictograms, hazard
statements, and precautionary
statements; a specified format for safety
data sheets; and related revisions to
definitions of terms used in the
standard, requirements for employee
training on labels and safety data sheets.
OSHA is also proposing to modify
provisions of a number of other
standards, including standards for
flammable and combustible liquids,
process safety management, and most
substance-specific health standards, to
ensure consistency with the modified
HCS requirements.
DATES: Written comments. Written
comments, including comments on the
information collection determination
described in Section VIII of the
preamble (OMB Review under the
Paperwork Reduction Act of 1995), must
be submitted by the following dates:
Hard copy: Comments must be
submitted (postmarked or sent) by
December 29, 2009.
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Facsimile and electronic
transmissions: Comments must be sent
by December 29, 2009.
Informal public hearings. The Agency
will schedule an informal public
hearing on the proposed rule. 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 by any of the
following methods:
Electronically: You may submit
comments electronically at https://
www.regulations.gov, which is the
Federal e-Rulemaking Portal. Follow the
instructions on-line for making
electronic submissions.
Fax: If your submissions, including
attachments, are not longer than 10
pages, you may fax them to the OSHA
Docket Office at (202) 693–1648.
Mail, hand delivery, express mail,
messenger or courier service: You must
submit three copies of your comments
to the OSHA Docket Office, Docket No.
OSHA–H022K–2006–0062, U.S.
Department of Labor, Room N–2625,
200 Constitution Avenue, NW.,
Washington, DC 20210. Deliveries
(hand, express mail, messenger and
courier service) are accepted during the
Department of Labor’s and Docket
Office’s normal business hours, 8:15
a.m.–4:45 p.m., E.T.
Instructions: All submissions must
include the Agency name and the
docket number for this rulemaking
(Docket No. OSHA–H022K–2006–0062).
All comments, including any personal
information you provide, are placed in
the public docket without change and
may be made available online at
https://www.regulations.gov. Therefore,
OSHA cautions you about submitting
personal information such as social
security numbers and birthdates.
Docket: To read or download
comments submitted in response to this
Federal Register notice, go to Docket
No. OSHA–H022K–2006–0062 at
https://www.regulations.gov or to the
OSHA Docket Office at the address
above. All comments are listed in the
https://www.regulations.gov index;
however, some information (e.g.,
copyrighted material) is not publicly
available to read or download through
that Web page. All comments, including
copyrighted material, are available for
inspection and copying at the OSHA
Docket Office.
Electronic copies of this Federal
Register document are available at
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https://regulations.gov. Copies also are
available from the OSHA Office of
Publications, Room N–3101, U.S.
Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210;
telephone (202) 693–1888. This
document, as well as news releases and
other relevant information, are also
available at OSHA’s Web page at
https://www.osha.gov.
FOR FURTHER INFORMATION CONTACT: For
general information and press inquiries,
contact Jennifer Ashley, Office of
Communications, Room N–3647, OSHA,
U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC 20210; telephone (202) 693–1999.
For technical information, contact
Maureen O’Donnell, Directorate of
Standards and Guidance, Room N–3718,
OSHA, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC 20210; telephone (202) 693–1950.
SUPPLEMENTARY INFORMATION:
I. Introduction
The preamble to the proposal to
modify the Hazard Communication
Standard 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 provisions
set forth in the proposed standard. The
discussion follows this outline:
I. Introduction
II. Issues
III. Events Leading to the Proposed
Modifications to the Hazard
Communication Standard
IV. Overview and Purpose of the Proposed
Modifications to the Hazard
Communication Standard
V. Need and Support for the Proposed
Modifications to the Hazard
Communication Standard
VI. Pertinent Legal Authority
VII. Preliminary Economic Analysis and
Initial Regulatory Flexibility Analysis
VIII. OMB Review Under the Paperwork
Reduction Act of 1995
IX. Federalism
X. State Plans
XI. Unfunded Mandates
XII. Protecting Children From Environmental
Health and Safety Risks
XIII. Environmental Impacts
XIV. Public Participation
XV. Summary and Explanation of the
Proposed Modifications to the Hazard
Communication Standard
(a) Purpose
(b) Scope
(c) Definitions
(d) Hazard Classification
(e) Written Hazard Communication
Program
(f) Labels and Other Forms of Warning
(g) Safety Data Sheets
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(h) Employee Information and Training
(i) Trade Secrets
(j) Effective Dates
(k) Other Standards Affected
(l) Appendices
XVI. References
XVII. Authority and Signature
XVIII. Proposed Amendments
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In the preamble, OSHA references a
number of supporting materials.
References to these materials are given
as ‘‘Document ID#’’ followed by the last
four digits of the document number. The
referenced materials are posted in
Docket No. OSHA–H022K–2006–0062
(which is available at https://
www.regulations.osha.gov). The
documents are also available at the
OSHA Docket Office (see ADDRESSES
section above). For further information
about accessing documents referenced
in this Federal Register notice, see
Section XIV (Public Participation—
Notice of Hearing).
II. Issues
OSHA requests comment on all
relevant issues, including economic
impact and feasibility, environmental
impact, effects on small entities,
proposed revisions to the HCS, and
subsequent modifications to other
standards. OSHA has received many
comments on the issues raised in the
Advance Notice of Proposed
Rulemaking (ANPR) (71 FR 53617,
September 12, 2006), and the Agency
has considered those comments in the
development of this proposal. This
section identifies issues on which the
Agency seeks additional information
and comment to supplement that
received in response to the ANPR, as
well as new topics related to this
proposal. While new comments are
welcome, OSHA requests that
comments submitted in response to the
ANPR not be resubmitted as they are
retained in the rulemaking record and
reconsidered throughout the process.
OSHA is including these issues at the
beginning of the document to assist
readers as they consider the comments
they plan to submit. However, to fully
understand the questions and provide
substantive input in response to them,
the parts of the preamble that address
these issues in detail should be read and
reviewed. These include Section VII,
which addresses the impacts of the
NPRM, and thus provides the
background related questions 2 through
5. Section XV provides the Summary
and Explanation of the proposed
regulatory text, and Section XVII is the
text itself. These are key to
understanding questions 6 through 26. It
should be noted that the Federal
Register’s required format for a
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modification of an existing standard
does not allow the Agency to provide
the full text of the rule, i.e., the
regulatory text in this document only
addresses those paragraphs that OSHA
is proposing to change. Therefore, the
Agency is putting a marked up version
of the text of the current rule on its web
page to help readers understand the
proposed changes in context. The
marked up text will be found on
www.osha.gov under Hazard
Communication in the subject index.
OSHA requests that comments be
organized, to the extent possible, around
the following issues and numbered
questions. Submitting comments in an
organized manner and with clear
reference to the issue raised will enable
all participants to easily see what issues
the commenter addressed and how they
were addressed. This is particularly
important in a rulemaking such as GHS
which affects many diverse industries.
Many commenters, especially small
businesses, are likely to confine their
interest (and comment) to the issues that
affect them, and they will benefit from
being able to quickly identify comment
on their issues in others’ submissions.
Of course, OSHA also welcomes
relevant comments concerning the
proposal that fall outside the issue
questions raised in this section.
However, the Agency is particularly
interested in receiving public responses,
supported by evidence and reasons, to
the following questions:
Need and Support for the Standard
1. OSHA has made a preliminary
determination that the proposed
modifications to the HCS would
increase the quality and consistency of
information provided to employers and
employees. Specifically, OSHA believes
that standardized label elements would
be more effective in communicating
hazard information; standardized
headings and a consistent order of
information would improve the utility
of SDSs; and training would support
and enhance the effectiveness of the
new label and SDS requirements. Is this
assessment correct? OSHA requests
information that reflects on the
effectiveness of the proposed
modifications to the HCS in protecting
employees from chemical hazards in the
workplace.
Economic Impacts and Economic
Feasibility
2. The preliminary economic analysis
in Section VII raises a variety of specific
questions and issues with respect to the
preliminary economic analysis. OSHA
would appreciate it if you could place
answers to these issues as heading 2 in
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your comments and further organize
comments on the preliminary economic
analysis (PEA) as follows:
a. Industrial profiles. This covers
issues concerning how many
employees, establishments and products
would be affected by the proposed
standard. OSHA welcomes comments
on all aspects of the industrial profile
and is particularly interested in
comments on the number of affected
employees, and the number of SDSs that
would need revision, by industry.
b. Issues with respect to estimated
benefits of the proposed standard.
OSHA considers three kinds of benefits
in this preliminary analysis: Benefits
associated with preventing injuries,
illnesses, and fatalities through clearer
and more accessible information;
benefits associated with reducing the
time that safety and health managers
and logistics and emergency response
personnel spend on hazardous
chemicals through clearer and easier-tofind information; and benefits
associated with reducing the time
needed to develop and review SDSs
because of international harmonization.
OSHA is particularly interested in
comments on the scope of these
benefits; the extent to which they are
already being achieved by existing
practices; and the extent to which they
depend on other countries following the
harmonization effort.
c. Issues with respect to the costs and
range of costs of the proposed standard.
OSHA preliminarily estimated the
principal costs of the standard to
chemical producers for reclassification
of chemicals; remaking SDS’s; and
redoing labels; and to chemical users for
familiarization and program changes for
managers and for training exposed
employees. OSHA welcomes comments
on all aspects of the costs, and is
particularly interested in comments on
the extent to which chemical producers
may have already met some of the
requirements of the standard and the
time and professional skills needed for
the activities the standard would
require.
d. Issues with respect to economic
impacts and feasibility of the proposed
standard, including the sensitivity of
OSHA’s economic feasibility
determination with respect to various
assumptions. OSHA welcomes
comments on all aspects of the
economic impact and economic
feasibility analyses.
e. All other issues with respect to the
PEA.
Effects on Small Entities
3. OSHA has certified that the
proposed standard will not have a
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significant impact on a substantial
number of small entities. Nevertheless,
because of the number of small entities
affected, OSHA has prepared a
voluntary initial regulatory flexibility
analysis, the results of which are
described in Section VII of the proposed
rule. Do you consider the estimated
costs and impacts on small entities
presented there to be reasonable? Why
or why not?
4. Are there alternatives to the rule as
a whole or specific requirements of the
rule that reduce impacts on small
entities while still protecting the health
of employees and meeting the broad
goal of a globally harmonized system?
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Environmental Impacts
5. OSHA has preliminarily
determined that the proposed standard
will not have any adverse effects on the
environment, and may have positive
effects on the environment. OSHA
welcomes comments on this
determination.
Hazard Classification
6. OSHA is proposing to adopt all of
the physical and health hazard classes
in the GHS. Among the physical and
health hazard classes, OSHA is
proposing to include all hazard
categories in the GHS except Acute
Toxicity Category 5 for oral, dermal, or
inhalation exposures; Skin Corrosion/
Irritation Category 3; and Aspiration
Hazard Category 2. If you believe that
the exclusion of these hazard categories
is not consistent with the scope and/or
level of protection provided by the
current HCS, please describe any
recommended changes to this proposal
and the reasons you think these changes
are necessary.
7. OSHA has proposed a definition for
unclassified hazards be added to the
HCS to ensure that all hazards currently
covered by the HCS—or new hazards
that are identified in the future—are
included in the scope of the revised
standard until such time as specific
criteria for the effect are added to the
GHS and subsequently adopted by
OSHA. Will this approach provide
sufficient interim coverage for hazards
such as combustible dust? Are there
other hazards for which criteria should
be developed and added to the GHS?
Please provide information regarding
these hazards, and the information
available to characterize them.
8. OSHA believes it may be more
appropriate to add specific coverage for
simple asphyxiants to the standard in
the final rule to ensure everyone
properly addresses their coverage rather
than addressing them under the
unclassified hazard definition. This
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effect is simple and straightforward, and
could be addressed in a definition that
does not involve extensive criteria.
OSHA is requesting comment on this
approach. A possible definition would
be as follows:
‘‘Simple asphyxiants’’ are substances that
displace oxygen in the ambient atmosphere,
and can thus cause oxygen deprivation in
exposed workers that leads to
unconsciousness and death. They are of
particular concern in confined spaces.
Examples of asphyxiants include: nitrogen,
helium, argon, propane, neon, carbon
dioxide, and methane.
OSHA would also like to solicit
comments on specific label elements for
simple asphyxiants. No symbol would
be required, but the signal word
‘‘warning’’ would be used, with the
hazard statement ‘‘may be harmful if
inhaled’’. In addition, a precautionary
statement such as the following would
be required: May displace oxygen in
breathing air and lead to suffocation and
death, particularly in confined spaces.
All other requirements of the standard
that apply to hazardous chemicals
would also apply to chemicals that meet
this definition. These substances would
generally be covered already under the
proposed rule as compressed gases, and
may also pose other effects such as
flammability that would have to be
addressed as well. They are also already
covered under the existing HCS. Is the
definition suggested by OSHA sufficient
to cover this effect? Do you have
suggestions for modifying this
definition? Are the label elements
suggested appropriate?
9. In order to help to ensure that
health hazard determinations are
properly conducted under a
performance-oriented approach, the
HCS includes a ‘‘floor’’ of chemicals
that are to be considered hazardous
based on several cited reference lists. In
addition, the existence of one
toxicological study indicating a possible
adverse effect is considered sufficient
for a finding of hazard for any health
effect. Under the GHS, there is no floor
of chemicals cited, nor is there an
across-the-board provision such as the
one-study criterion. Instead, specific,
detailed criteria are provided for each
type of health hazard to guide the
evaluation of relevant data and
subsequent classification of the
chemical. The proposed modifications
to the HCS would align the standard to
the GHS approach, and thus do not
include the floor of chemicals nor the
universal one-study rule. Would the
proposed detailed criteria provide
sufficient guidance for a thorough
hazard evaluation?
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10. OSHA has edited the chapters in
the GHS for classification of physical
and health hazards to remove material
not directly related to classification and
to otherwise streamline the text. OSHA
anticipates providing the decision logics
separately to serve as guidance, but has
not included them in the regulatory text.
Are there any additions, subtractions, or
clarifications of the classification
criteria from the GHS that OSHA needs
to consider?
11. Certain physical hazard
classification criteria (i.e., for selfreactive chemicals, organic peroxides,
self-heating chemicals, explosives)
either directly reference packaging or
quantity, or rely on test methods that
reference packaging or quantity. The
criteria were developed for transport
concerns. Clearly, quantity and
packaging can greatly affect safe
transport of chemicals that pose hazards
such as those listed above. However,
OSHA seeks comments on whether the
criteria as stated in the GHS are
appropriate for the workplace. Does use
of these criteria present any obstacles to
classification or create any difficulties
for suppliers or users of chemicals?
Describe any difficulties these criteria
may present and any suggestions for
addressing these issues, particularly
recommendations that would be
consistent with the GHS and maintain
the GHS level of safety for these
chemicals.
12. The GHS gives countries guidance
on a cut-off or concentration limit for
chemical mixtures containing target
organ toxicity hazards. In Appendix A,
Section A.8.3, OSHA is proposing to
make the suggested 20% concentration
limit mandatory so that label preparers
are clear on what needs to be done.
Please comment on whether this
mandatory concentration limit is
appropriate. If you have an alternative,
please provide it along with the
rationale.
Labels
13. The proposal would require
pictograms to have a red frame. As
discussed in Section V, OSHA believes
that use of the color red will make
warnings more noticeable and will aid
in communicating the presence of a
hazard. However, the GHS gives
competent authorities such as OSHA the
discretion to allow use of a black frame
when the pictogram appears on a label
for a package which will not be
exported. For packages that will not be
exported, should the modified standard
allow black frames on pictograms, or
should the pictogram frame be required
to be presented in red?
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14. In addition to the pictograms,
signal word and hazard statements, GHS
labels must include precautionary
statements. OSHA is proposing to
require the text in the precautionary
statements in the GHS to be on HCS
labels. As discussed in Section XV
Summary and Explanation of the
Proposed Standard, these statements are
codified under the GHS, meaning that
numbers have been assigned to them. In
addition, the appropriate statements to
use for each hazard class and category
have been indicated in the GHS
annexes. This means that label
preparers will know exactly what
precautionary statements to apply once
they complete their hazard
classification, and chemical users will
see consistent language on labels to
indicate the necessary precautionary
measures. However, the statements are
not yet considered to be part of the
harmonized text like hazard statements
are; rather they are included in the GHS
as an suggested language. OSHA expects
that other countries may adopt the
codified precautionary statements when
they put GHS in place. For example the
EU has required that labels use the GHS
codified precautionary statement text in
adapting the GHS. Since OSHA did not
previously require the use of
precautionary statements, and had no
such recommended statements to
provide, the Agency is proposing to use
those currently in the GHS as the
mandatory requirements with the option
of consolidating statements where
appropriate (See Appendix C). OSHA
anticipates this approach will provide
the maximum benefit. OSHA is also
seeking comment on whether any of
these statements should be modified or
if other precautionary statements should
be included.
In addition, as discussed in Section
IV, OSHA has presented other
alternatives with regards to
precautionary statements, and OSHA is
soliciting comment on these options as
well. Specifically, OSHA is seeking
feedback on whether the Agency should
include the GHS precautionary
statements as nonbinding examples,
through a non mandatory appendix or
guidance, rather than as required
statements, or whether OSHA should
allow label preparers to develop their
own precautionary statements rather
than specifying the text to be used.
15. OSHA has not proposed to require
the exploding bomb pictogram or
specific precautionary statements for
Division 1.4S ammunition and
ammunition components because the
specified GHS label elements may not
accurately reflect the hazards of these
materials. Is this sufficiently protective?
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Are any adjustments to the label
elements for Division 1.4S ammunition
and ammunition components
necessary? Describe any requested
changes and explain why such revisions
are necessary.
16. In the current HCS, OSHA has a
provision that requires labels to be
updated within three months of
obtaining new and significant
information about the hazards. The
Agency has not been enforcing this
provision for many years, and there has
been an administrative stay on
enforcement. OSHA is including the
provision in this proposal, and inviting
comment on it with the intention of
including it in the final rule and lifting
the stay. Is three months the appropriate
time interval for updating? Are there
any practical accommodations that need
to accompany this limit (for example,
related to stockpiles of chemicals)?
Provide any alternatives you consider
appropriate, as well as documentation
to support them.
Safety Data Sheets (SDSs)
17. As discussed in Section XV, the
Agency is proposing to require that
OSHA permissible exposure limits
(PELs) be included on the SDS, as well
as any other exposure limit used or
recommended by the chemical
manufacturer, importer, or employer
preparing the safety data sheet. OSHA
welcomes comments on this approach,
along with an explanation of the basis
for your position.
18. OSHA is proposing that Section
15 of the SDS be non-mandatory. As
indicated in Appendix D, Section 15
addresses regulatory information
concerning the chemical. OSHA is
considering requiring the substance
specific standards be referenced in this
section, which would make Section 15
mandatory. Would employers and
employees benefit from having this
information in this section of the SDS?
Other Standards Affected
19. OSHA is proposing to align the
definitions of the physical hazards to
the requirements of the GHS categories
in safety standards for general industry,
construction, and maritime standards,
which either directly reference the HCS
or provide information pertinent to the
Safety Data Sheets (SDSs). In most cases
OSHA has modified the standards to
maintain scope and protection.
However, the changes in definitions for
flammable liquids Category 1 and 2 and
flammable aerosols appear to be more
than simply rounding to the nearest
significant number.
Æ Flammable liquids Category 1 and
2: The boiling point cut-off for Category
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1 is reduced from 100 deg F (37.8 deg
C) or less to 95 deg F (35 deg C) or less,
which could shift some liquids from
Category 1 to Category 2.
Æ Flammable aerosols: OSHA is
proposing to adopt the GHS method to
determine flammability rather than the
method defined by the Consumer
Product Safety Commission (CPSC).
OSHA’s decision to change these
definitions to be consistent with the
GHS is based not only upon
harmonizing its standards with those of
other countries that have adopted or
may adopt the GHS, but OSHA is also
concerned with making its standards
internally consistent. OSHA believes the
methods used to classify these physical
hazards are similar enough so that
substances that are currently regulated
by OSHA would continue to be
regulated and that few, if any, changes
would result in a shift in regulatory
coverage. Would the proposed changes
have any impact on your operations? If
so, describe the anticipated effects.
20. OSHA is proposing to eliminate
the term ‘‘combustible liquid’’ in 29
CFR 1910.106. 1910.107, 1910.123,
1910.124, 1910.125, and 1926.155 for
liquids with a flashpoint above 100 °F.
To reflect consistency with the revised
HCS where appropriate, OSHA is
proposing to add the specific flashpoint
criteria. This will maintain equivalent
protection. Are there other standards
that OSHA should update with the new
terminology?
21. OSHA is proposing to modify the
language required on signs in substancespecific health standards. The Agency
developed the proposed language to
reflect the terminology of the revised
HCS while, at the same time, providing
adequate warning through language that
is consistent with the current sign
requirements for these chemicals. An
added benefit is the hazard warnings on
signs specified for these standards will
now be consistent throughout OSHA
standards. For example, all carcinogens
will now bear the hazard statement
‘‘MAY CAUSE CANCER’’. OSHA
believes that providing language that is
consistent on both signs and labels will
improve comprehension for employees.
Does the proposed language on signs
accurately convey the hazards?
22. OSHA is proposing to revise the
substance-specific health standards’
provisions on labeling for producers and
importers of chemicals and substances.
Currently in the substance-specific
standards OSHA requires specific
language on labels for certain chemicals.
OSHA is proposing to change these
labeling requirements by referring those
responsible for labeling to the modified
HCS and including in each substance-
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specific standard a list of health effects
that must be considered for hazard
classification. The modified HCS will
dictate the specific language (i.e., signal
word, hazard statement(s), and
precautionary statement(s)) that is
required on labels through the
classification process. However, OSHA
is proposing to maintain specific
language for labels on contaminated
clothing and waste/debris containers to
ensure adequate hazard communication
for the downstream recipients. How
would the removal of required language
for labels from substance-specific
standards affect your work place? Are
there hazard warnings that will be lost
that do not have an equivalent hazard or
precautionary statement? Are there
alternatives to OSHA’s approach for the
substance-specific standards that will
assure information is disseminated in a
manner that is consistent with the
modified HCS labeling requirements?
23. In determining the health hazards
that need to be considered by
manufacturers, importers and
distributors when classifying chemicals
regulated by the substance-specific
standards, OSHA is proposing to
primarily rely on the determinations
made by the Agency in each
rulemaking, the NIOSH Pocket Guide to
Chemical Hazards (2005) and the
International Chemical Safety Cards,
and use as a secondary source the health
effects identified by the European
Commission (2007). OSHA is proposing
to include a health hazard only if it is
identified as such by two or more of
these organizations. Are there other
sources of information that OSHA
should consult?
24. As detailed in the Summary and
Explanation section of this document,
OSHA is not proposing in this
rulemaking to update the electrical
standards (general industry 1910
subpart S and construction 1926 subpart
K) or Explosives and blasting agents
(general industry 1910.109 and
construction 1926.914). These subparts
are ‘‘self-contained’’ in that they do not
rely on other OSHA standards for
regulatory scope or definitions, but
reference external organizations (such as
the National Fire Protection Association
[NFPA]). OSHA believes that these
standards could be updated when the
referenced external organizations adopt
applicable GHS elements. If OSHA were
to change these standards to comply
with the GHS, how would this impact
your operations?
Effective Dates
25. OSHA has proposed to require
that employers train employees
regarding the new labels and safety data
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sheets within two years after
publication of the final rule to ensure
they are familiar with the new approach
when they begin to see new labels and
SDSs in their workplaces. Is the
proposed time appropriate?
26. OSHA has proposed that chemical
manufacturers, importers, distributors,
and employers be required to comply
with all provisions of the modified final
rule within three years after its
publication. Does this allow adequate
time to review hazard classifications
and amend them as necessary, and to
revise labels and safety data sheets to
reflect the new requirements? Would a
shorter time frame be sufficient?
27. Are there any other factors that
should be considered in establishing the
phase-in period?
Compliance Assistance and Outreach
28. OSHA received many comments
in response to the questions in the
ANPR regarding compliance assistance
and outreach and is seeking additional
comment in this proposal. However,
comments already submitted need not
be resubmitted. Please refer to the
discussion in Section XV. Specifically,
OSHA is interested in your responses to
the following: What types of materials
or products would best assist employers
in understanding and complying with
the modified HCS? OSHA seeks input to
identify the tools that would be most
useful to employers and employees, the
subjects of greatest interest (e.g.,
classification criteria, labels, safety data
sheets), and the best means of
distributing these materials.
29. OSHA received a number of
comments that suggested that a data
base of chemical classifications should
be developed and maintained to assist
chemical manufacturers and importers
in performing hazard classifications.
This approach has been adopted in
some other countries. Would such a
data base be helpful? Who would be
responsible for doing the classifications
and maintaining them? How would the
data base be kept aligned with other
countries’ classifications?
Alternative Approaches
30. OSHA has described alternatives
to the scope and application of the
proposed rule in the preamble, Section
IV. These include consideration of
allowing voluntary implementation of
the GHS; exemptions based on size of
the business; adopting some
components of the GHS but not others;
and not adopting all of the required
label elements. The Agency requests
comments on these alternatives, with
data to support the views expressed.
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Suggestions and support for other
alternatives are requested as well.
III. Events Leading to the Proposed
Modifications to the Hazard
Communication Standard
OSHA’s Hazard Communication
Standard (HCS) (29 CFR 1910.1200;
1915.1200; 1917.28; 1918.90; and
1926.59) was first issued in 1983 and
covered the manufacturing sector of
industry (48 FR 53280, November 25,
1983). In 1987, the Agency expanded
the scope of coverage to all industries
where employees are potentially
exposed to hazardous chemicals (52 FR
31852, August 24, 1987). Although full
implementation in the nonmanufacturing sector was delayed by
various court and administrative
actions, the rule has been fully enforced
in all industries covered by OSHA since
March 17, 1989 (54 FR 6886, February
15, 1989). In 1994, OSHA made a
number of minor changes and technical
amendments to the HCS to help ensure
full compliance and achieve better
protection of employees (59 FR 6126,
February 9, 1994). The development of
the HCS is discussed in detail in the
preambles to the original and revised
final rules (see 48 FR 53280–53281; 52
FR 31852–31854; and 59 FR 6127–
6131). This discussion will focus on the
sequence of events leading to the
development of the Globally
Harmonized System of Classification
and Labelling of Chemicals (GHS) and
the modifications to the HCS included
in this proposed rule.
The HCS requires chemical
manufacturers and importers to evaluate
the chemicals they produce or import to
determine if they are hazardous. The
rule provides definitions of health and
physical hazards to use as the criteria
for determining hazards in the
evaluation process. Information about
hazards and protective measures is then
required to be conveyed to downstream
employers and employees through
labels on containers and safety data
sheets. All employers with hazardous
chemicals in their workplaces are
required to have a hazard
communication program, including
container labels, safety data sheets, and
employee training. (Note: The HCS uses
the term ‘‘material safety data sheet’’ or
‘‘MSDS’’, while the GHS uses ‘‘safety
data sheet’’ or ‘‘SDS’’. For convenience
and for consistency with the GHS, safety
data sheet or SDS is being used
throughout this document and that term
would replace MSDS in the modified
HCS.)
To protect employees and members of
the public who are potentially exposed
to chemicals during their production,
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transportation, use, and disposal, a
number of countries have developed
laws that require information about
those chemicals to be prepared and
transmitted to affected parties. These
laws vary with regard to the scope of
chemicals covered, definitions of
hazards, the specificity of requirements
(e.g., specification of a format for safety
data sheets), and the use of symbols and
pictograms. The inconsistencies
between the various laws are substantial
enough that different labels and safety
data sheets must often be developed for
the same product when it is marketed in
different nations.
Within the U.S., several regulatory
authorities exercise jurisdiction over
chemical hazard communication. In
addition to OSHA’s HCS, the
Department of Transportation (DOT)
regulates chemicals in transport, the
Consumer Product Safety Commission
(CPSC) regulates consumer products,
and the Environmental Protection
Agency (EPA) regulates pesticides, as
well as having other authority over
labeling under the Toxic Substances
Control Act. Each of these regulatory
authorities operates under different
statutory mandates, and has adopted
distinct hazard communication
requirements.
Tracking the hazard communication
requirements of different regulatory
authorities is a burden for
manufacturers, importers, distributors,
and transporters engaged in commerce
in the domestic arena. This burden is
magnified by the need to develop
multiple sets of labels and safety data
sheets for each product in international
trade. Small businesses may have
particular difficulty in coping with the
complexities and costs involved. The
problems associated with differing
national and international requirements
were recognized and discussed when
the HCS was first issued in 1983. The
preamble to the final rule included a
commitment by OSHA to review the
standard regularly to address
international harmonization of hazard
communication requirements. OSHA
was asked to include this commitment
in recognition of an interagency trade
policy that supported the U.S. pursuing
international harmonization of
requirements for chemical classification
and labeling. The potential benefits of
harmonization were noted in the
preamble:
* * * [O]SHA acknowledges the long-term
benefit of maximum recognition of hazard
warnings, especially in the case of containers
leaving the workplace which go into
interstate and international commerce. The
development of internationally agreed
standards would make possible the broadest
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recognition of the identified hazards while
avoiding the creation of technical barriers to
trade and reducing the costs of dissemination
of hazard information by elimination of
duplicative requirements which could
otherwise apply to a chemical in commerce.
As noted previously, these regulations will
be reviewed on a regular basis with regard to
similar requirements which may be evolving
in the United States and in foreign countries.
(48 FR 53287)
OSHA has actively participated in a
number of such efforts in the years since
that commitment was made, including
trade-related discussions on the need for
harmonization with major U.S. trading
partners. The Agency also issued a
Request for Information (RFI) in the
Federal Register in January 1990 to
obtain input regarding international
harmonization efforts, and on work
being done at that time by the
International Labor Organization (ILO)
to develop a convention and
recommendations on safety in the use of
chemicals at work (55 FR 2166, January
22, 1990). On a closely related matter,
OSHA published an RFI in May 1990
requesting comments and information
on improving the effectiveness of
information transmitted under the HCS
(55 FR 20580, May 17, 1990). Possible
development of a standardized format or
order of information was raised as an
issue in the RFI. Nearly 600 comments
were received in response to this
request. The majority of responses
expressed support for a standard SDS
format, and the majority of responses
that expressed an opinion on the topic
favored a standardized format for labels
as well.
In June 1992, the United Nations
Conference on Environment and
Development issued a mandate (Chapter
19 of Agenda 21), supported by the U.S.,
calling for development of a globally
harmonized chemical classification and
labeling system:
A globally harmonized hazard
classification and compatible labelling
system, including material safety data sheets
and easily understandable symbols, should
be available, if feasible, by the year 2000.
This international mandate initiated a
substantial effort to develop the GHS,
involving numerous international
organizations, many countries, and
extensive stakeholder representation.
A coordinating group comprised of
countries, stakeholder representatives,
and international organizations was
established to manage the work. This
group, the Inter-Organization
Programme for the Sound Management
of Chemicals Coordinating Group for the
Harmonization of Chemical
Classification Systems, established
overall policy for the work and assigned
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tasks to other organizations to complete.
The Coordinating Group then took the
work of these organizations and
integrated it to form the GHS. OSHA
served as chair of the Coordinating
Group.
The work was divided into three main
parts: Classification criteria for physical
hazards; classification criteria for health
and environmental hazards (including
criteria for mixtures); and hazard
communication elements, including
requirements for labels and safety data
sheets. The criteria for physical hazards
were developed by a United Nations
Subcommittee of Experts on the
Transport of Dangerous Goods/
International Labour Organization
working group and were based on the
already harmonized criteria for the
transport sector. The criteria for
classification of health and
environmental hazards were developed
under the auspices of the Organization
for Economic Cooperation and
Development. The ILO developed the
hazard communication elements. OSHA
participated in all of this work, and
served as U.S. lead on classification of
mixtures and hazard communication.
Four major existing systems served as
the primary basis for development of the
GHS. These systems were the
requirements in the U.S. for the
workplace, consumers and pesticides;
the requirements of Canada for the
workplace, consumers and pesticides;
European Union directives for
classification and labeling of substances
and preparations; and the United
Nations Recommendations on the
Transport of Dangerous Goods. The
requirements of other systems were also
examined as appropriate, and taken into
account as the GHS was developed. The
primary approach to reconciling these
systems involved identifying the
relevant provisions in each system;
developing background documents that
compared, contrasted, and explained
the rationale for the provisions; and
undertaking negotiations to find an
agreed approach that addressed the
needs of the countries and stakeholders
involved. Principles to guide the work
were established, including an
agreement that protections of the
existing systems would not be reduced
as a result of harmonization. Thus
countries could be assured that the
existing protections of their systems
would be maintained or enhanced in the
GHS.
An interagency committee under the
auspices of the Department of State
coordinated U.S. involvement in the
development of the GHS. In addition to
OSHA, DOT, CPSC, and EPA, there
were a number of other agencies
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involved that had interests related to
trade or other aspects of the GHS
process. Different agencies took the lead
in various parts of the discussions.
Positions for the U.S. in these
negotiations were coordinated through
the interagency committee. Interested
stakeholders were kept informed
through e-mail dissemination of
information, as well as periodic public
meetings. In addition, the Department of
State published a notice in the Federal
Register that described the
harmonization activities, the agencies
involved, the principles of
harmonization, and other information,
as well as invited public comment on
these issues (62 FR 15951, April 3,
1997). Stakeholders also actively
participated in the discussions at the
international level and were able to
present their views directly in the
negotiating process.
The GHS was formally adopted by the
new United Nations Committee of
Experts on the Transport of Dangerous
Goods and the Globally Harmonized
System of Classification and Labelling
of Chemicals in December 2002. In
2003, the adoption was endorsed by the
Economic and Social Council of the
United Nations. The GHS will be
updated as necessary to reflect new
technology and scientific developments,
or provide additional explanatory text.
This proposed rule is based on Revision
3 of the GHS, published in 2009.
Countries have been encouraged to
implement the GHS as soon as possible,
and established a goal to have fully
operational systems by 2008. This goal
was adopted by countries in the
Intergovernmental Forum on Chemical
Safety, and was endorsed by the World
Summit on Sustainable Development.
The U.S. participated in these groups,
and agreed to work toward achieving
these goals. While much progress was
made by the U.S. and other countries by
the end of 2008, most are still in the
process of implementing the GHS.
OSHA published an Advance Notice
of Proposed Rulemaking (ANPR) on the
GHS in September of 2006 (71 FR
53617, September 12, 2006). The ANPR
provided information about the GHS
and its potential impact on the HCS,
and sought input from the public on
issues related to GHS implementation.
Over 100 responses were received, and
the comments and information provided
were taken into account in the
development of the modifications to the
HCS included in this proposed rule. At
the same time the ANPR was published,
OSHA made a document summarizing
the GHS available on its Web site
(https://www.osha.gov).
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OSHA remains engaged in a number
of activities related to the GHS. The U.S.
is a member of both the United Nations
Committee of Experts on the Transport
of Dangerous Goods and the Globally
Harmonized System of Classification
and Labeling of Chemicals, as well as
the Subcommittee of Experts on the
Globally Harmonized System of
Classification and Labeling of
Chemicals. These permanent UN bodies
have international responsibility for
maintaining, updating as necessary, and
overseeing the implementation of the
GHS. OSHA and other affected Federal
agencies actively participate in these
UN groups. In addition, OSHA and EPA
also participate in the GHS Programme
Advisory Group under the United
Nations Institute for Training and
Research (UNITAR). UNITAR is
responsible for helping countries
implement the GHS, and has ongoing
programs to prepare guidance
documents, conduct regional
workshops, and implement pilot
projects in a number of nations. OSHA
also continues to be involved in
interagency discussions related to
coordination of domestic
implementation of the GHS, and in
discussions related to international
work to implement and maintain the
GHS.
IV. Overview and Purpose of the
Proposed Modifications to the Hazard
Communication Standard
The intent of the HCS is to ensure that
the hazards of all chemicals are
evaluated, and that information
concerning chemical hazards and
associated protective measures is
transmitted to employers and
employees. The standard achieves this
goal by requiring chemical
manufacturers and importers to review
available scientific evidence concerning
the physical and health hazards of the
chemicals they produce or import to
determine if they are hazardous. For
every chemical found to be hazardous,
the chemical manufacturer or importer
must develop a container label and an
SDS and provide both documents to
downstream users of the chemical. All
employers with employees exposed to
hazardous chemicals must develop a
hazard communication program, and
ensure that exposed employees are
provided with labels, access to SDSs,
and training on the hazardous chemicals
in their workplace.
The three information components in
this system—labels, SDSs, and
employee training—are all essential to
the effective functioning of the program.
Labels provide a brief, but immediate
and conspicuous summary of hazard
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information at the site where the
chemical is used. 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. Training is designed
to ensure that employees understand the
chemical hazards in their workplace
and are aware of protective measures to
follow. Labels, SDSs, and training are
complementary parts of a
comprehensive hazard communication
program—each element reinforces the
knowledge necessary for effective
protection of employees.
Information required by the HCS
reduces the incidence of chemicalrelated illnesses and injuries by
enabling employers and employees to
implement protective measures in the
workplace. Employers can select less
hazardous chemical alternatives and
ensure that appropriate engineering
controls, work practices, and personal
protective equipment are in place.
Improved understanding of chemical
hazards by supervisory personnel
results in safer handling of hazardous
substances, as well as proper storage
and housekeeping measures.
Employees provided with information
and training on chemical hazards are
able to fully participate in the protective
measures instituted in their workplaces.
Knowledgeable employees can take the
steps required to work safely with
chemicals, and are able to determine
what actions are necessary if an
emergency occurs. Information on
chronic effects of exposure to hazardous
chemicals helps employees recognize
signs and symptoms of chronic disease
and seek early treatment. Information
provided under the HCS also enables
health and safety professionals to
provide better services to exposed
employees. Medical surveillance,
exposure monitoring, and other services
are enhanced by the ready availability of
health and safety information.
OSHA believes that the
comprehensive approach adopted in the
HCS—requiring evaluation of chemicals
and the transmittal of information
through labels, SDSs, and training—is
sound. The proposed modifications to
the rule do not alter that approach.
Rather, the proposed modifications to
the rule are intended to improve the
effectiveness of the HCS by enhancing
the quality and consistency of the
information provided to employers and
employees. OSHA believes this can be
accomplished by modifying the
requirements of the standard to conform
with the more specific and detailed
provisions of the GHS for classification,
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labeling, and SDSs. OSHA’s rationale
for this belief is summarized below. The
evidence supporting this preliminary
conclusion is presented in Section V of
this preamble, and the proposed
revisions to the HCS are discussed in
detail in Section XV.
HCS Provisions for Classification,
Labeling, and SDSs
The HCS covers a broad range of
health and physical hazards. The
standard is performance-oriented,
providing definitions of hazards and
parameters for evaluating the evidence
to determine whether a chemical is
considered hazardous. The evaluation is
based upon evidence that is currently
available, and no testing of chemicals is
required.
The standard covers every type of
health effect that may occur, including
both acute and chronic effects.
Definitions of a number of adverse
health effects are provided in the
standard. These definitions are
indicative of the wide range of coverage,
but are not exclusive. Any adverse
health effect that is substantiated by a
study conducted according to
established scientific principles, and
reporting a statistically significant
outcome, is sufficient for determining
that a chemical is hazardous under the
rule.
Most chemicals in commerce are not
present in the pure state (i.e., as
individual elements or compounds), but
are provided as mixtures of chemicals.
Evaluation of the health hazards of
mixtures is based on data for the
mixture as a whole when such data are
available. When data on the mixture as
a whole are not available, the mixture is
considered to present the same health
hazards as any ingredients present at a
concentration of 1% or greater, or, in the
case of carcinogens, concentrations of
0.1% or greater. The HCS also
recognizes that risk may remain at
concentrations below these cut-offs, and
where there is evidence that is the case,
the mixtures are considered hazardous
under the standard.
The current definitions of physical
hazards in the HCS were derived from
other OSHA standards that address such
chemicals (e.g., flammable chemicals),
or from the DOT criteria for physical
hazards at the time OSHA promulgated
the HCS. DOT subsequently changed
their criteria to be consistent with the
internationally harmonized transport
requirements, and the HCS criteria for
classification of physical hazards are
generally not consistent with current
DOT requirements.
The HCS establishes requirements for
minimum information that must be
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included on labels and SDSs, but does
not provide specific language to convey
the information or a format in which to
provide it. When the HCS was issued in
1983, the public record strongly
supported this performance-oriented
approach (see 48 FR 53300–53310).
Many chemical manufacturers and
importers were already providing
information voluntarily, and in the
absence of specific requirements had
developed their own formats and
approaches. The record indicated that a
performance-oriented approach would
reduce the need for chemical
manufacturers and importers to revise
these existing documents to comply
with the HCS, thus reducing the cost
impact of the standard. In recognition of
the work that had been voluntarily
completed, OSHA decided to allow
labels and SDSs to be presented in any
format desired, as long as the minimum
information requirements of the
standard were met.
GHS Provisions for Classification,
Labeling, and SDSs
The GHS is an internationally
harmonized system for classifying
chemical hazards and developing labels
and safety data sheets. However, the
GHS is not a model standard that can be
adopted verbatim. Rather, it is a set of
criteria and provisions that regulatory
authorities can incorporate into existing
systems, or use to develop a new
system.
The GHS is designed to allow
regulatory authorities to choose
provisions that are appropriate to their
particular sphere of regulation. This is
referred to as the ‘‘building block
approach.’’ The GHS includes all of the
regulatory components, or building
blocks, that might be needed for
classification and labeling requirements
for chemicals in the workplace,
transport, pesticides, and consumer
products.
Regulatory authorities such as OSHA
adopt the provisions of the GHS that are
appropriate for their particular
regulatory sector, but do not need to
adopt all of the criteria and provisions
of the GHS. For example, the GHS
includes criteria for classifying
chemicals for aquatic toxicity. Since
OSHA does not have the regulatory
authority to address environmental
concerns, OSHA would not adopt the
GHS criteria for aquatic toxicity. The
building block approach may also be
applied to the criteria for defining
hazards. For example, the acute toxicity
criteria in the GHS are much broader
than those currently found in the HCS.
This is to allow consumer product
authorities the ability to address the
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protection of children and other
vulnerable populations. OSHA would
not need to adopt all of the acute
toxicity categories to maintain
protection of employees in the
workplace.
The building block approach can also
be applied when a regulatory authority
decides which parts of the system to
adopt. For example, the GHS includes
classification criteria and provisions for
labels and SDSs. While OSHA is
proposing to adopt all of these elements
because the current HCS cover labels
and SDSs, consumer product and
transportation authorities are not
expected to require SDSs.
Under the GHS, each hazard or
endpoint (e.g., Explosives,
Carcinogenicity) is considered to be a
hazard class. The classes are generally
sub-divided into categories of hazard.
The definitions of hazards are more
specific and detailed than those
currently in the HCS. For example,
under the HCS, a chemical is either an
explosive or it is not. Under the GHS,
there are seven categories of explosives,
and assignment to these categories is
based on the classification criteria
provided.
The GHS generally applies a tiered
approach to evaluation of mixtures. The
first step is consideration of data on the
mixture as a whole. The second step
allows the use of ‘‘bridging principles’’
to estimate the hazards of the mixture
based on information about its
components. The third step of the tiered
approach involves use of cut-off values
based on the composition of the
mixture, or for acute toxicity, a formula
which is used for classification. The
approach is generally consistent with
the current requirements of the HCS, but
provides more detail and specification
and allows for extrapolation of data
available on the components of a
mixture to a greater extent—particularly
for acute effects.
Hazard communication requirements
under the GHS are directly linked to the
hazard classification. For each class and
category of hazard, a harmonized signal
word (e.g., Danger), pictogram (e.g.,
skull and crossbones), and hazard
statement (e.g., Fatal if Swallowed) are
specified. These specified elements are
referred to as the core information for a
chemical. Thus, once a chemical is
classified, the GHS provides the specific
core information to convey to users of
that chemical. The core information
allocated to each category generally
reflects the degree of severity of the
hazard. Precautionary statements are
also required on GHS labels. The GHS
provides example precautionary
statements, but they are not yet
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considered formally harmonized. In
other words, it would be possible for
regulatory authorities to use different
language for the precautionary
statements. However, it appears likely
that the language in the examples will
become the harmonized text of the GHS
on precautionary statements in the near
future. The most recent revision to the
GHS has codified these statements (i.e.,
assigned numbers to them) as well as
aligned them with the hazard classes
and categories. Codification allows
reference to them in a shorthand form,
and makes it easier for authorities using
them in regulatory text to organize
them. In addition, there are provisions
to allow supplementary information so
that chemical manufacturers can
provide data in addition to the specified
core information.
The GHS establishes a standardized
16-section format for SDSs to provide a
consistent sequence for presentation of
information to SDS users. Items of
primary interest to exposed employees
and emergency responders are
presented at the beginning of the
document, while more technical
information is presented later. Headings
for the sections (e.g., First Aid
Measures, Handling and Storage) are
standardized to facilitate locating
information of interest. The harmonized
data sheets are consistent with the order
of information included in the voluntary
industry consensus standard for safety
data sheets (ANSI Z400.1).
Advantages of the Proposed
Modifications to the Standard
OSHA believes that the detailed and
specific classification requirements of
the GHS would result in better, more
consistent information being provided
to employers and employees.
Classification under the revised criteria
would not only indicate the type of
hazard, but would generally give an
indication of the degree of severity of
the hazard as well. This information
would be helpful to both employers and
employees in understanding chemical
hazards and identifying and
implementing protective measures. The
detailed criteria for classification are
also expected to result in greater
accuracy in hazard classification and
more consistency among classifiers. By
following the detailed criteria,
classifiers are less likely to reach
different interpretations of the same
data.
OSHA also believes that standardized
presentation of information on labels
and safety data sheets would improve
the comprehensibility of chemical
hazard information. Employers and
employees would be given the same
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core information on a chemical
regardless of the supplier. Use of
standardized pictograms would
complement and reinforce the
information provided through signal
words and hazard statements.
Pictograms are also anticipated to
improve communication for those who
are not functionally literate, or who are
not literate in the language used on the
label. The standardized format for SDSs
is expected to make the information
easier for users to find, with the
information employees and emergency
responders need most appearing in the
beginning of the document for easy
identification and reference.
Standardized requirements for labels
and SDSs are also expected to increase
the accuracy of chemical hazard
information. With consistent
presentation of information, the task of
reviewing SDSs and labels to assure
accuracy would be simplified.
Individuals preparing and reviewing
these documents should find it easier to
identify any missing elements, and
OSHA enforcement personnel should be
able to more efficiently examine SDSs
and labels when conducting
inspections.
Another advantage that will result
from adopting a system that has
harmonized hazard statements in it
relates to the use of ‘‘control banding,’’
a guidance approach to recommending
control measures for chemical
exposures. The approach uses
information that is readily available to
small and medium-sized employers
with chemicals in their workplaces to
provide them with workplace-specific
control recommendations. Basically, the
system uses such information to
estimate the degree of severity of the
hazard and the amount of chemical
present, and relates that to the degree of
control needed. The control banding
approach relies on harmonized hazard
statements to allow the system to
estimate the degree of severity of the
hazard. Initially based on the European
hazard classification system, it has now
been converted to the GHS phrases. The
use of control banding to provide
guidance for chemical safety and health
approaches in U.S. workplaces cannot
be accomplished until harmonized
hazard statements are readily available.
Adoption of the GHS and its phrases
would open up the possibility that
control banding guidance can be used in
the U.S. to help small and mediumsized employers select and implement
appropriate control measures. For more
information on control banding, please
see https://www.cdc.gov/niosh/topics/
ctrlbanding/.
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OSHA is proposing modifications to
the HCS that are necessary for
consistency with the GHS. The GHS
does not include requirements for a
written hazard communication program
or for employee training. OSHA is not
proposing any substantive changes to
the requirements for a written hazard
communication program. However,
OSHA believes that additional training
would be necessary to ensure that
employees understand some elements of
the new system. In particular, some
training and familiarization would be
needed for pictograms to be effective.
The Agency is therefore proposing
modified training requirements to
address the new label elements and SDS
format that would be required under the
revised standard.
The GHS leaves certain matters to the
competent authority (i.e., the regulatory
authority with jurisdiction over that
sector) to determine. OSHA would
maintain its current approaches in these
situations. For example, the scope and
application provisions in the HCS
address the interface of the OSHA
requirements with requirements of other
agencies. These scope provisions would
remain unchanged under the proposed
rule.
The proposed modifications to the
HCS primarily affect manufacturers and
importers of hazardous chemicals.
Chemical manufacturers and importers
would be required to re-evaluate
chemicals according to the new criteria
in order to ensure they are classified
appropriately. For health hazards, this
will necessitate placing the chemical in
the appropriate hazard category as well
as the hazard class. For physical
hazards, however, the new criteria are
generally consistent with current DOT
requirements for transport. Therefore, if
the chemicals are transported (i.e., they
are not produced and used in the same
workplace), this classification should
already be done for physical hazards for
purposes of complying with DOT’s
transport requirements. This should
minimize the additional work required
for classification of physical hazards.
Preparation and distribution of modified
labels and safety data sheets by
chemical manufacturers and importers
would also be required. Those chemical
manufacturers and importers already
following the ANSI Z400.1 standard for
safety data sheets should already have
the appropriate format, and would only
be required to make some small
modifications to the content of the
sheets to be in compliance.
Compliance requirements for
chemical users would be limited.
Workplaces where chemicals are used
would need to integrate the new
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approach into their hazard
communication program, assuring that
employees understand the pictograms
and other information provided on
labels and SDSs. Employers who use
chemicals, and exposed employees,
would benefit from receiving labels and
safety data sheets presented in a
consistent format. The information
should be easier to find and
comprehend, allowing it to be used
more effectively for the protection of
employees.
Changing the HCS to make it conform
to the GHS will also make it necessary
to modify a number of other OSHA
standards. Modifications are proposed
to the standards for Flammable and
Combustible Liquids in general industry
(29 CFR 1910.106) and construction (29
CFR 1926.152) to align the requirements
of the standards with the GHS hazard
categories for flammable liquids. A
modification to the Process Safety
Management standard (29 CFR
1910.119) is proposed to ensure that the
scope of the standard is not changed by
the proposed modifications to the HCS.
In addition, modifications to most of
OSHA’s substance-specific health
standards are proposed to ensure that
requirements for signs and labels are
consistent with the modified HCS.
OSHA’s preliminary determination to
modify the HCS is based on its
assessment of the potential to improve
employee safety and health by adopting
the GHS approach to hazard
communication. However, GHS
implementation is also expected to
accomplish a number of other
objectives, and produce additional
benefits. By providing an internationally
comprehensible system for hazard
communication, the GHS is anticipated
to enhance the protection of the
environment and of human health in all
sectors, not only the workplace. The
GHS provides a framework for
developing a hazard communication
system for those countries without an
existing system, thus protecting
employees around the world and
helping to ensure that the appropriate
information is received with chemicals
imported into American workplaces.
Implementation of the GHS is also
expected to reduce the need for testing
and evaluation of chemicals, since
classification would be based on
existing data and would only need to be
performed once for each substance. In
addition, implementation of the GHS is
expected to facilitate international trade
in chemicals, as the need to identify and
comply with diverse and complex
hazard communication requirements in
different countries would be reduced or
eliminated.
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Alternative Approaches
In this section OSHA presents several
alternatives to the proposed GHS
modification to the HCS to respond to
concerns raised by commenters through
the ANPR. OSHA provides the
following discussion of these
alternatives and their potential impacts
and requests comments regarding their
relative costs, benefits, feasibility,
impact on small businesses, impact on
worker safety and health, and any other
issues on which commenters may wish
to provide feedback.
This rulemaking seeks to improve
employee protections by adopting an
internationally harmonized approach to
hazard communication issues. While
the current HCS provides protections for
exposed workers by disseminating
information about chemicals in their
workplaces, OSHA believes, as
discussed in Section V, that the
adoption of GHS strengthens and refines
the system, and gives OSHA the
opportunity to improve worker safety by
improving hazard communications. The
GHS has the same general concept of an
integrated, comprehensive process of
identifying and communicating hazards,
but provides more extensive criteria to
define the hazards in a consistent
manner, as well as standardizes label
elements and SDS formats to help to
ensure that the information is conveyed
consistently.
Additionally, the Agency believes that
adoption of the GHS as proposed will
simplify implementation insofar as
OSHA’s preferred alternative would
clearly be considered ‘‘harmonized’’
with other regulatory authorities in the
world, and thereby acquire the full
benefits of harmonization.
This is in line with the GHS, which
anticipates that countries will adopt the
hazard classification criteria and
required label elements, as well as SDS
requirements in workplaces. As stated
in the introduction to the GHS (3rd
revision):
1.1.3.1.3 In the workplace, it is expected
that all of the GHS elements will be adopted,
including labels that have the harmonized
core information under the GHS, and safety
data sheets. It is also anticipated that this
will be supplemented by employee training
to help ensure effective communication.
As addressed in Section XV, many
commenters supported the concept of
OSHA moving forward to adopt the
GHS (Document ID #s 0003, 0007, 0047,
0050, 0052, 0062, 0106, 0011, 0033,
0038, 0123, 0130, 0151, 0163, and
0171). While others objected to
adoption, OSHA has identified and
responded to their concerns in Section
XV as well. In addition, there were
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several commenters who noted that
small chemical manufacturers that are
not in international trade of chemicals
would have a large burden associated
with adopting the GHS, and
questionable benefits due to their lack of
international trade. (Document ID #
0022). Others simply noted that they
believed there would be high costs and
limited benefits for such employers, or
that it would be costly and difficult to
adopt (Document ID #s 0015, 0026,
0178, and 0144). There was no
discussion in any of these comments
about potential alternatives.
It should be noted that it appears that
all of these commenters assumed the
primary benefits of adopting the GHS
would be in facilitating international
trade. As has been addressed in Section
VII, OSHA has based the benefits of this
action on improved communication to
workers and has provided initial
estimates of a range of benefits that
would be achieved in this area; trade
benefits which, while recognized, have
not been quantified. Therefore,
grandfathering or other exemptions
related to this rule might result in
workers in those facilities receiving
lower benefits of increased
comprehensibility relative to workers in
other types and sizes of workplaces;
OSHA considers this a serious concern
that could potentially exclude a group
of workers exposed to hazardous
chemicals from the increased benefits
associated with clearer and more
specific classification criteria, as well as
standardized label elements.
Alternatives:
In order to respond to the concerns
raised in these comments, OSHA
solicits comment on several options:
1. The first option is designed to
facilitate voluntary adoption of GHS
within the existing HCS framework.
Specifically, this approach would
involve recognition and adoption of the
GHS, with minimal changes to the
current HCS. Under this approach,
entities could opt to adopt GHS or
continue to follow their current practice
under HCS.
Therefore, companies would decide
whether they would continue
complying with the existing standard, or
comply with the GHS. This would
reduce the costs for those companies
that choose to remain in compliance
with the existing HCS, and allow those
companies that foresee the benefits of
GHS compliance from a trade
perspective to adopt its provisions.
Another version of this option would be
to exempt small chemical producers
from complying.
2. A second option that OSHA is
seeking to solicit comment on would
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make modifications to the current HCS
in order to improve hazard
communication through adoption of
components of the GHS. Under this
option OSHA would add requirements
for standardized hazard statements,
signal words, and precautionary
statements being added to the current
HCS, but otherwise would follow the
approach outlined in Alternative 1
above.
Since the standardized labels are
relatively inexpensive to implement,
while reviewing classifications is more
costly, this has the potential to reduce
the overall cost of implementation of the
revised rule.
A variation on this alternative would
entail incorporation of some, but not all,
of the label elements. In particular, the
Agency would not adopt the
precautionary statements since these are
not yet considered to be ‘‘harmonized’’
under the GHS—they are provided for
guidance and reference, but competent
authorities may choose to implement
other statements. The precautionary
statements could be adopted later when
they are harmonized under the GHS. Or,
alternatively, OSHA could either allow
label preparers to use whatever
precautionary statements they deem
appropriate or develop its own set of
statements to require.
From OSHA’s perspective, a key issue
regarding the alternative approaches
presented is that the classification
criteria in the GHS are different from the
hazard definitions in the current HCS.
In general, as discussed in Section XV,
they cover the same scope of hazard so
these differences do not result in
significant differences in the chemicals
covered. But the GHS criteria divide
most of the hazard classes into hazard
categories that convey the severity of the
effect, while few of the hazard classes in
the current HCS take this approach. The
standardized label elements are
associated with these specific hazard
categories, i.e., the harmonized
pictograms, signal words, and hazard
statements are assigned by hazard
category and reflect the degree of hazard
it presents to those exposed. Likewise,
the precautionary statements assigned
are also reflective of the degree of
hazard, with responses related to these
presumed hazard levels.
Additionally, with regard to the first
alternative, there will be chemicals that
will be classified in different hazards
classes under the GHS classification
scheme versus the HCS hazard
determination step. In addition, these
chemicals will also be assigned to
hazard categories under GHS where
there are none now. This is particularly
true for the classification of mixtures for
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all hazards, except the chronic health
hazards, since the hazard determination
scheme in the current HCS is based
solely on concentration limits and the
GHS classification scheme is based on
bridging principles. Under the
alternatives presented workers might be
given different hazard information when
exposed to a chemical purchased from
two different suppliers. OSHA notes
that this would be similar to the
situation under the current
performance-oriented HCS, but this
approach may forego an opportunity to
make the system more consistent.
OSHA is interested in comments
related to the alternatives addressing the
extent to which differences in
classification between the GHS and HCS
might create confusion or otherwise
result in problems. OSHA is further
interested in comments addressing the
classification of mixtures under the
alternatives discussed, given the
differences in classification under HCS
and GHS applicable to mixtures.
Given the current variability in MSDS
and labels under the performance based
HCS, OSHA believes that this approach
might not have a negative impact on
safety and health relative to our current
HCS. However, the Agency anticipates
that components of the GHS would
confer benefits external to producers
(e.g., the benefits associated with clearer
and more specific classification criteria,
as well as labels or other changes that
could potentially make easier for users
to locate and understand the
information they are seeking), adoption
of this alternative could result in
foregone benefits. In addition, a small
number of chemicals or mixtures might
be labeled differently due to differing
categorization results between the
existing HCS and GHS.
OSHA is generally seeking comment
on the possible cost impacts associated
with the alternatives on the chain of
chemical suppliers. OSHA notes that
large and small producers are not
mutually exclusive so that a large
business or distributers engaged in
international trade cannot simply and
straightforwardly choose to implement
the GHS regardless of their suppliers.
Small businesses sell to large
businesses. If small businesses do not
adopt the GHS, then the large
businesses or the distributor would
either have to generate GHS
classifications for chemicals they buy
from them or request that small
businesses supply data and labels using
GHS classifications. Likewise, chemical
producers often provide their products
to distributors who then sell them to
customers unknown to the original
producer. Thus knowing whether or not
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a product will wind up in international
trade may be questionable in some
situations. A producer may provide a
substance to another company, who
then formulates it into a product that is
sold internationally—thus the original
producer is involved in international
trade without necessarily realizing it. In
theses cases, costs would be incurred for
the conversion to GHS. This issue was
raised in comments regarding the
effective dates for the rule, when many
suggested it was not appropriate to
differentiate dates based on the size of
the business. For example, ORC
Worldwide, Inc. stated (Document ID #
0123):
OSHA should consider a company’s place
in the manufacturing supply chain, not size,
in determining how the phase-in is
implemented. It would be sensible to start
with producers of raw materials and basic
chemicals. The technical information,
classification and categorization they perform
will be useful downstream for the
intermediate chemical producers and
specialty chemical manufacturers. Lastly, the
end user will benefit from the influx of
information developed by the upstream
professionals.
OSHA solicits comment on whether a
voluntary system, or a system based on
business size, could be successfully
implemented given the structure of the
supply system.
OSHA seeks comment on how
companies that use chemicals, but don’t
produce them, would be affected under
an alternative approach. Rather than
potentially simplifying compliance and
improving comprehensibility, the user
of chemicals would continue to see
variation in labels on purchased
chemicals. This would be further
complicated by the fact that the
underlying criteria for these labels may
be different as well, and thus the
warnings would be too. If there is no
requirement for such employers to be
familiar with the new system, and train
their employees, then there will be new
pictograms and signal words with no
structure for ensuring they are
understood and the appropriate
precautions are implemented.
Regarding Alternative 2, under
OSHA’s proposed approach the label
provisions are relatively cost-efficient to
adopt given that the GHS assigns the
various required elements by hazard
class and category and once the
classification or re-classification has
been accomplished, the GHS provides
the specific information for the label.
OSHA solicits comment on whether
requiring this standardized approach to
labeling under the HCS, without the
infrastructure of the GHS will be
burdensome for the chemical
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manufacturer to accomplish OSHA
further solicits comment on whether
confusion may result from labels that
may look the same but which actually
reflect different classification criteria.
Under this approach, chemical
producers will have to assess their
current determinations and attempt to
relate them to the established hazard
classes and categories. Alternatively,
OSHA could create a regulatory system
assigning HCS categories to each GHS
label elements; comments are welcomed
on the impact on benefits and costs, and
the feasibility of such an approach.
OSHA believes it is unlikely that this
component of Alternative 2 would
provide significant savings over
reviewing classifications for purposes of
putting the chemicals into GHS classes
and categories.
OSHA is concerned that chemical
producers following this approach
might not be able to use their labels in
other countries where the GHS has been
adopted. OSHA is further concerned
that adopting only some elements of the
GHS label may be confusing and may
fail to provide useful information
regarding the possible hazardous effects
of exposure. Delaying adoption of the
precautionary statements may also
reduce the effectiveness of the labels
significantly, and reduce the
appropriate information on the SDSs as
well. A variation on this alternative—to
simply require precautionary
statements, but not to specify what they
are, may generate significant variation
due to the performance-oriented
approach that allows the label preparer
to determine what they are or if they are
included. One communication
advantage of providing the information
in the same language from label-to-label
is that workers and other users can be
assured that the same action is required.
If you take a simple preventive measure
such as ‘‘wash your hands,’’ but convey
it in several different ways, the reader
of the label will think you mean
something different. This is one of the
advantages of providing the text for
these statements in the revised HCS. In
addition, since these precautionary
statements will be translated, this
should make it easier for those
participating in international trade to
produce and use labels.
Thus, OSHA solicits comment on a
range of alternative approaches to
regulatory adoption of GHS and
welcomes comments on these options.
The costs and benefits are further
addressed in Section VII.
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V. Need and Support for the Proposed
Modifications to the Hazard
Communication Standard
Chemical exposure can cause or
contribute to many serious adverse
health effects such as cancer, sterility,
heart disease, lung damage, and burns.
Some chemicals are also physical
hazards and have the potential to cause
fires, explosions, and other dangerous
incidents. It is critically important that
employees and employers are apprised
of the hazards of chemicals that are used
in the workplace, as well as associated
protective measures. This knowledge is
needed to understand the precautions
necessary for safe handling and use, to
recognize signs and symptoms of
adverse health effects related to
exposure when they do occur, and to
identify appropriate measures to be
taken in an emergency.
OSHA established the need for
disclosure of chemical hazard
information when the HCS was issued
in 1983 (48 FR 53282–53284). This need
continues to exist. The Agency
estimates that 880,000 hazardous
chemicals are currently used in the U.S.,
and over 40 million employees are now
potentially exposed to hazardous
chemicals in over 5 million workplaces.
Chemical exposures result in a
substantial number of serious injuries
and illnesses among exposed
employees. The Bureau of Labor
Statistics estimates that employees
suffered 55,400 illnesses that could be
attributed to chemical exposures in
2007, the latest year for which data are
available (BLS, 2008). In that same year,
17,340 chemical-source injuries and
illnesses involved days away from work
(BLS, 2009).
The BLS data, however, do not
indicate the full extent of the problem,
particularly with regard to illnesses. As
noted in the preamble to the HCS in
1983, BLS figures probably only reflect
a small percentage of the incidents
occurring in exposed employees (48 FR
53284). Many occupational illnesses are
not reported because they are not
recognized as being related to workplace
exposures, are subject to long latency
periods between exposure and the
manifestation of disease, and other
factors (e.g., Herbert and Landrigan,
2000; Leigh et al., 1997; Landrigan and
Markowitz, 1989).
The HCS currently serves to ensure
that information concerning chemical
hazards and associated protective
measures is provided to employers and
employees. However, OSHA’s
experience, along with information
acquired since the HCS was issued,
indicates that modifications to the
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standard may be appropriate. The
Agency believes that the proposed
changes, based on the GHS, will
substantially improve the quality and
consistency of the information provided
to employers and employees. OSHA
further believes the proposed revisions
to the HCS will enhance workplace
protections, because better information
will enable employers and employees to
take measures that would result in a
reduction in the number and severity of
chemical-related injuries and illnesses.
A key foundation underlying this
belief relates to the comprehensibility of
information conveyed under the GHS.
All hazard communication systems deal
with complicated scientific information
being transmitted to largely nontechnical audiences. During the
development of the GHS, in order to
construct the most effective hazard
communication system, information
about and experiences with existing
systems were sought to help ensure that
the best approaches would be used.
Ensuring the comprehensibility of the
GHS was a key issue during its
development. As noted in a Federal
Register notice published by the U.S.
Department of State (62 FR 15956, April
3, 1997): ‘‘A major concern is to ensure
that the requirements of the globally
harmonized system address issues
related to the comprehensibility of the
information conveyed.’’ This concern is
also reflected in the principles of
harmonization that were used to guide
the negotiations and discussions during
the development of the GHS. As
described in Section 1.1.1.6(g) of the
GHS, the principles included the
following: ‘‘[T]he comprehension of
chemical hazard information, by the
target audience, e.g., workers,
consumers and the general public
should be addressed.’’
To help in the development of the
GHS, OSHA had a review of the
literature conducted to identify studies
on effective hazard communication, and
made the review and the analysis of the
studies available to other participants in
the GHS process. Prepared by
researchers at the University of
Maryland, the document entitled
‘‘Hazard Communication: A Review of
the Science Underpinning the Art of
Communication for Health and Safety’’
(Sattler et al., 1997) has also long been
available to the public on OSHA’s
Hazard Communication web page. More
recently, OSHA conducted an updated
review of the literature published since
the 1997 review. This updated review
examined the literature relevant to
specific hazard communication
provisions of the GHS (ERG, 2007).
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Further work related to
comprehensibility was conducted
during the GHS negotiations by
researchers in South Africa at the
University of Cape Town—the result is
an annex to the GHS related to
comprehensibility testing (see GHS
Annex 6, Comprehensibility Testing
Methodology) (United Nations, 2009).
Such testing has been conducted in
some of the developing countries
preparing to implement the GHS, and
has provided these countries with
information about which areas in the
GHS will require more training in their
programs to ensure people understand
the information. The primary purpose of
these activities was to ensure that the
system developed was designed in such
a way that the messages would be
effectively conveyed to the target
audiences, with the knowledge that the
system would be implemented
internationally in different cultures with
varying interests and concerns.
Also among the agreed principles that
were established to guide development
of the GHS was that the level of
protection offered by an existing hazard
communication system should not be
reduced. Following these principles, the
best aspects of existing systems were
identified and included in a single,
harmonized approach to classification,
labeling, and development of SDSs.
The GHS was developed by a large
group of experts representing a variety
of perspectives. Over 200 experts
provided technical input on the project.
The United Nations Sub-Committee of
Experts on the GHS, the body that
formally adopted the GHS and is now
responsible for its maintenance,
includes 32 member nations as well as
17 observer nations. Authorities from
these member states are able to convey
the insight and understanding acquired
by regulatory authorities in different
sectors, and to relate their own
experiences in implementation of
hazard communication requirements. In
addition, over two dozen international
and intergovernmental organizations,
trade associations, and unions are
represented, and their expertise serves
to inform the member nations. The GHS
consequently represents a consensus
recommendation of experts with regard
to best practices for effective chemical
hazard communication, reflecting the
collective knowledge and experience of
regulatory authorities in many nations
and in different regulatory sectors, as
well as other organizations that have
expertise in this area. A number of
United States-based scientific and
professional associations have endorsed
adoption of the GHS. The American
Chemical Society indicated its support
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for the GHS, stating: ‘‘The American
Chemical Society (ACS) strongly
supports the adoption of the GHS for
hazard communication in general and
specifically as outlined in the ANPR’’
adding that ‘‘* * * ACS anticipates that
OSHA implementation of GHS in the
U.S. will enhance protection of human
health and the environment through
warnings and precautionary language
that are consistent across different
products and materials as well as across
all workplaces’’ (Document ID #0165).
In comments submitted in response to
the ANPR, the American Industrial
Hygiene Association (AIHA) affirmed its
support for modification of the HCS to
adopt the GHS. AIHA maintained that
standardized labels and safety data
sheets will make hazard information
easier to use, thereby improving
protection of employees (Document ID
#0034). The American Society of Safety
Engineers also indicated its support for
the GHS rulemaking (Document ID
#0139). While acknowledging that the
GHS presents a number of concerns and
challenges, the Society of Toxicology
has also expressed its support for the
GHS, stating that ‘‘a globally
harmonized system for the classification
of chemicals is an important step
toward creating consistent
communications about the hazards of
chemicals used around the world’’
(SOT, 2007). The American Association
of Occupational Health Nurses joined
these organizations in advocating
adoption of the GHS, arguing that
standardization of chemical hazard
information is critical to protecting the
safety and health of employees
(Document ID #0099). The positions
taken by these organizations point to
wide support for the GHS among the
scientific and professional communities.
In addition to the endorsement of the
GHS by a group of experts with
extensive knowledge and experience in
chemical hazard communication and
support from scientific and professional
associations with expertise in this area,
a substantial body of evidence indicates
that the proposed modifications to the
HCS will better protect employees.
Specifically, this evidence supports
OSHA’s belief that: (1) Standardized
label elements—signal words,
pictograms, hazard statements and
precautionary statements—would be
more effective in communicating hazard
information; (2) standardized headings
and a consistent order of information
would improve the utility of SDSs; and
(3) training would support and enhance
the effectiveness of the new label and
SDS requirements.
This evidence was obtained from a
number of sources. OSHA has
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commissioned several studies to
examine the quality of information on
SDSs (Karstadt, 1988; Kearney/Centaur
1991a, 1991b; Lexington Group, 1999);
the General Accounting Office (GAO)
has issued two reports based on its
evaluation of certain aspects of the HCS
(GAO 1991, 1992); a National Advisory
Committee on Occupational Safety and
Health (NACOSH) workgroup
conducted a review of hazard
communication and published a report
of its findings (NACOSH, 1996); and a
substantial amount of scientific
literature relating to hazard
communication has been published. As
mentioned previously, OSHA
commissioned a review of the literature,
and a report based on that review was
published in 1997 (Sattler et al., 1997).
An updated review was published in
2007 (ERG, 2007). In addition, OSHA
conducted a review of the requirements
of the HCS and published its findings in
March of 2004 (OSHA, 2004). Key
findings derived from these sources are
discussed below.
OSHA’s rationale for adopting the
GHS is tied to anticipated
improvements in the quality and
consistency of the information that
would be provided to employers and
employees. Hazard classification is the
foundation for development of this
improved information. Indeed, hazard
classification is the procedure of
identifying and evaluating available
scientific evidence in order to determine
if a chemical is hazardous, and the
degree of hazard, pursuant to the criteria
for health and physical hazards set forth
in the standard. Hazard classification
provides the basis for the hazard
information that is provided in labels,
SDSs, and employee training. As such,
it is critically important that
classification be performed accurately
and consistently.
The GHS provides detailed scientific
criteria to direct the evaluation process.
The specificity and detail provided help
ensure that different evaluators would
reach the same conclusions when
evaluating the same chemical.
Moreover, the GHS refines that
classification process by establishing
categories of hazard within most hazard
classes. These categories indicate the
relative degree of hazard, and thereby
provide a basis for determining precise
hazard information that is tailored to the
level of hazard posed by the chemical.
The classification criteria established in
the GHS thus provide the necessary
basis for development of the specific,
detailed hazard information that would
enhance the protection of employees.
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Labels
Labels provide a brief, conspicuous
hazard summary at the work site where
a chemical is used. Labels serve as an
immediate visual reminder of chemical
hazards, and complement the
information presented in training and
on SDSs.
The HCS currently requires that labels
on hazardous chemical containers
include the identity of the hazardous
chemical; appropriate hazard warnings
that convey the specific physical and
health hazards, including target organ
effects; and the name and address of the
chemical manufacturer, importer, or
other responsible party. The HCS does
not specify a standard format or design
elements for labels.
OSHA is proposing a requirement that
labels include four new, standardized
elements: a signal word; hazard
statement(s); pictogram(s); and
precautionary statement(s) (see Section
XV for a detailed discussion of the
proposed requirements). The
appropriate label elements for a
chemical would be determined by the
hazard classification. OSHA believes
that these standardized label elements
would better convey critically important
hazard warnings, and provide useful
information regarding precautionary
measures that would serve to better
protect employees.
A great deal of literature has been
developed that examines the
effectiveness of warnings on labels.
However, some important limitations
must be recognized in applying this
information to workplace labels for
hazardous chemical products. Most
studies have examined labels for
prescription and non-prescription
medications, alcoholic beverages, or
consumer products. Relatively few
studies pertain specifically to labels for
hazardous chemicals in the workplace.
Much of the literature is also
characterized by the use of research
subjects such as college students or
consumers. Such subjects may not be
representative of workplace
populations, as these subjects may differ
from typical employees in terms of
product knowledge, hazard perception,
perceptual abilities, and safety
motivation. In addition, some studies
involve non-U.S. populations that may
not be representative of the U.S.
workforce.
Nevertheless, the literature provides a
substantial body of information
applicable to workplace chemical labels.
In spite of the differences in affected
populations, workplace chemical labels
have many characteristics that are
comparable to those found in other
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sectors. Pharmaceutical labels, for
example, are similar to chemical labels
in that they often have explicit
instructions for use which, if not
followed, can cause adverse health
effects or death. Designers of
pharmaceutical labels also encounter
many of the same challenges faced by
those who design chemical labels, such
as container space limitations and the
need to convey information to lowliterate or non-English literate users. In
addition, some of the research is not
directly related to any particular sector
or type of product. Some findings
related to use of color, for example,
could reasonably be applied to a wide
variety of label applications. Relevant
finding from the literature are presented
in the sections that follow.
Signal Words
A signal word is a word that typically
appears near the top of a warning,
sometimes in all capital letters.
Common examples include DANGER,
WARNING, CAUTION, and NOTICE.
The signal word is generally understood
to serve a dual purpose: alerting the user
to a hazard and indicating a particular
level of hazard. For example, users
generally perceive the word DEADLY to
indicate a far greater degree of hazard
than a term like NOTICE.
The proposal prescribes one of two
signal words for labels—DANGER or
WARNING—depending on the hazard
classification of the substance in
question. These are the same two signal
words used in the GHS. DANGER is
used for the more severe hazard
categories, while WARNING denotes a
less serious hazard. These signal words
are similar to those in other established
hazard communication systems, except
that some other systems have three or
more tiers. For example, ANSI Z129.1
(the American National Standard for
Hazardous Industrial Chemicals—
Precautionary Labeling) uses DANGER,
WARNING, and CAUTION, in order of
descending severity (ANSI, 2006).
A number of recent studies have
examined how people perceive signal
words and, in particular, how they
perceive signal words to be different
from one another. Overall, this research
supports the use of signal words in
labels, demonstrating that they can
attract attention and help people clearly
distinguish between levels of hazard.
The research also supports the decision
to use only two tiers, as many recent
studies have found clear differences
between DANGER and WARNING but
little perceived difference between
WARNING and CAUTION.
Wogalter et al. investigated the
influence of signal words on
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perceptions of hazard for consumer
products (Wogalter et al., 1992). Under
the pretext of a marketing research
study, 90 high school and college
students rated product labels on
variables such as product familiarity,
frequency of use, and perceived hazard.
Results showed that the presence of a
signal word increased perceived hazard
compared to its absence. Between
extreme terms (e.g., NOTE and
DANGER), significant differences were
noted.
Seeking to test warning signs in
realistic settings, Adams et al. tested
five industrial warning signs on a group
of 40 blue-collar workers employed in
heavy industry, as well as a group of
students (Adams et al., 1998). Signs
were manipulated to include four key
elements (signal word, hazard
statement, consequences statement, and
instructions statement) or a subset of
those elements. Participants were asked
questions to gauge their reaction and
behavioral intentions. Overall, 77
percent (66 percent of the worker group)
recognized DANGER as the key word
when it appeared, and more than 80
percent recognized BEWARE and
CAUTION, suggesting that the signal
word was generally noticed, and it was
recognized as the key alerting element.
DANGER was significantly more likely
than other words to influence
behavioral intentions.
Laughery et al. also demonstrated the
usefulness of signal words. The authors
tested the warnings on alcoholic
beverage containers in the U.S., and
found that a signal word (WARNING)
was one of several factors that decreased
the amount of time it took for
participants to locate the warning.
(Laughery et al., 1993).
Several studies have tested the
arousal strength or perceived hazard of
different signal words. Arousal strength
is a term used to indicate the overall
importance of the warning, and
incorporates both the likelihood and
severity of the potential threat. Silver
and Wogalter tested the arousal strength
of signal words on college students and
found that DANGER connoted greater
strength than WARNING and CAUTION
(Silver and Wogalter, 1993). The results
failed to show a difference between
WARNING and CAUTION. Among other
words tested, DEADLY was seen as
having the strongest arousal
connotation, and NOTE the least.
Griffith and Leonard asked 80 female
undergraduates (who were unlikely to
have already received industrial safety
training) to rate signal words. Results
included a list of terms in order of
‘‘meaningfulness,’’ representing
conceptual ‘‘distance’’ from the neutral
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term NOTICE (Griffith and Leonard,
1997). From most to least meaningful,
these terms were reported to be
DANGER, URGENT, BEWARE,
WARNING, STOP, CAUTION, and
IMPORTANT.
Wogalter et al. asked over 100
undergraduates and community
volunteers to rank signal words
(Wogalter et al., 1998). DEADLY was
perceived as most hazardous, followed
by DANGER, WARNING, and
CAUTION. All differences were
statistically significant. In a follow-up
experiment using labels produced in the
ANSI Z535.2 (American National
Standard for Environmental and Facility
Safety Signs), ANSI Z535.4 (American
National Standard for Product Safety
Signs and Labels), and alternative
formats, the authors found a similar
rank order for signal words with all
labeling systems. Finally, the authors
tested the same terms on employees
from manufacturing and assembly
plants and found the same general
order: DEADLY, then DANGER, then
WARNING and CAUTION with no
significant difference between the last
two terms.
In more of a free-form experiment,
Young asked 30 subjects to produce
warning signs for a set of scenarios,
using different sign components
available on a computer screen (Young,
1998). In roughly 80 percent of the
signs, the participant chose to use a
signal word. DANGER, DEADLY, and
LETHAL were more likely to be used for
scenarios with severe hazards;
CAUTION and NOTICE for non-severe
scenarios. WARNING was used equally
in both types of scenarios. The author
suggests that these results support a
two-tiered system of signal words. In a
separate task, users ranked the
perceived hazard of signal words,
resulting in the following list from most
to least severe: DEADLY, LETHAL,
DANGER, WARNING, CAUTION, and
NOTICE.
While these studies have focused on
the relative perceptions of signal words,
others have sought to evaluate how the
absolute meaning of common signal
words is perceived. Drake et al. asked a
group of students and community
volunteers to match signal words with
definitions borrowed from consensus
standards and other sources (Drake et
al., 1998). Participants matched
DANGER to a correct definition 64
percent of the time, while NOTICE was
matched correctly 68 percent of the
time. WARNING and CAUTION were
matched correctly less than half of the
time, suggesting confusion. The authors
recommended using WARNING and
CAUTION interchangeably. The authors
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also suggested that a standard set of
signal words (but not synonyms) is
helpful for users with limited English
skills, who can be trained to recognize
a few key words.
Signal word perceptions are reported
to be consistent among some non-U.S.
populations, as well. Hellier et al. asked
984 adults in the UK to rate DANGER,
WARNING, and CAUTION on a hazard
scale from 1 (low) to 10 (high) (Hellier
et al., 2000a). DANGER was ranked as
8.5, WARNING was ranked as 7.8, while
CAUTION was rated as 7.25. These
results are consistent with the findings
of studies on subjects in the U.S. In a
second study published in 2000, Hellier
et al. asked a mixed-age group of
participants in the UK to rate the
arousal strength of 84 signal words
commonly used in the U.S. (Hellier et
al., 2000b).The authors found that
DANGER is stronger than WARNING,
while WARNING and CAUTION are not
significantly different from each other.
Similar results were found among
workers in Zambia. Banda and
Sichilongo tested GHS-style labels using
four different signal words (as well as
other variables) (Banda and Sichilongo,
2006). Among workers in the industrial
and transport sectors, DANGER was
generally perceived as the most
hazardous signal word. WARNING was
one of a group of terms that were largely
indistinguishable from one another, but
distinct from DANGER. The authors
support adoption of the GHS, suggesting
that having just two possible signal
words will lead to ‘‘more impact and
less confusion about the extent of
hazard.’’
In addition, comparable results were
found in South Africa (London, 2003).
In a large study on SDS and label
comprehensibility conducted for South
Africa’s National Economic
Development and Labour Council
(NEDLAC), DANGER was generally
ranked as more hazardous than
WARNING by participants in the four
sectors tested: industry, transport,
agriculture, and consumers.
Cumulatively, these studies provide a
clear indication that signal words are
effective in alerting readers that a
hazard exists, and in conveying the
existence of a particular level of hazard.
The studies have found a generally
consistent hierarchy of signal words
with respect to perceived hazard.
DANGER and WARNING appear to
connote different levels of hazard, while
the perceived difference between
WARNING and CAUTION is often
insignificant.
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Pictograms
A pictogram is a graphical
composition that may include a symbol
along with other graphical elements,
such as a border or background color. A
pictogram is a communication tool and
is intended to convey specific
information.
The proposed rule includes
requirements for use of eight different
pictograms. Each of these pictograms
consists of a different symbol in black
on a white background within a red
square frame set on a point (i.e., a red
diamond). The specific pictograms that
are required on a label would be
determined based on the hazard
classification of the substance in
question.
OSHA believes that the proposed
pictograms would make warnings on
labels more noticeable and easier for
employees to understand. In particular,
symbols are expected to improve
comprehension among people with low
literacy and those who are not literate
in the English language. It should be
remembered that pictograms would be
used not only in conjunction with other
label elements, but in the context of the
hazard communication program as a
whole. Training that includes an
explanation of labels (included in the
proposed rule) would ensure that
pictograms are understood by
employees.
A considerable amount of evidence
supports the belief that pictograms can
serve as useful and effective
communication tools. In reviewing this
evidence, it should be noted that some
sources offer distinct definitions for
‘‘pictogram,’’ ‘‘pictorial,’’ ‘‘symbol,’’ and
other terms describing graphical
elements. For example, Rogers et al.
state that: ‘‘Pictorials refer to pictures
that represent the concept of interest
(e.g., a picture of a fire extinguisher).
Symbols are more abstract
representations of a concept, the
meaning of which must be learned (e.g.,
the use of a skull and crossbones to
denote poison)’’ (Rogers et al., 2000).
ANSI and others combine these terms in
the definition of ‘‘symbol,’’ however,
and for the purposes of discussing the
literature on this subject, these terms are
used interchangeably.
Symbols serve several important
functions in warning labels. As
Wogalter et al. explain, symbols may
alert the user to a hazard more
effectively than text alone:
Symbols may be more salient than text
because of visual differentiations of shape,
size, and color. Usually symbols have unique
details and possess more differences in
appearance than do the letters of the
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alphabet. Letters are highly familiar and are
more similar to one another than most
graphical symbols (Wogalter et al., 2006).
Symbols also can bolster a text message
and improve label comprehension
among individuals with low literacy,
and those who do not understand the
language in which the label text is
written (Parsons et al., 1999).
Several researchers have sought to
evaluate how people comprehend
symbols, including those symbols that
are incorporated in the proposed rule.
Some studies have found that the skull
and crossbones icon—one of the
symbols included in the proposed
rule—is among the most recognizable
safety symbols. For example, Wogalter
et al. asked 112 undergraduates and
community volunteers to rank various
label elements (Wogalter et al., 1998).
Among shapes and icons, the skull
symbol (in this case, without the
crossbones) was rated most hazardous
and most noticeable. The skull connoted
the greatest hazard among industrial
employees as well. Smith-Jackson and
Wogalter asked 48 English-speaking
workers to rate the perceived hazards of
six alerting symbols (Smith-Jackson and
Wogalter, 2000). The skull was rated
significantly higher than all other
symbols.
Some research has examined other
pictograms included in the proposed
rule. As part of an experiment to see
how individuals comprehend warnings
on household chemical labels,
Akerboom and Trommelen asked 60
university students whether they
understood the meaning of several
pictograms, including four that are
included in the proposed rule
(Akerboom and Trommelen, 1998). The
authors reported the following levels of
comprehension for these pictograms:
• Flame: 93 percent comprehension;
• Skull and crossbones: 85 percent
comprehension;
• Corrosion: 20 percent
comprehension; and
• Flame over circle: 13 percent
comprehension.
Only the flame and skull and
crossbones pictograms met the 85
percent comprehension criteria
suggested by ANSI Z535.3 (the
American National Standard Criteria for
Safety Symbols) (ANSI, 2002a). The
authors recommend that labels present
the hazard phrase [statement] and
symbol together, along with
corresponding precautions, as would be
required under the proposed rule.
Banda and Sichilongo tested
comprehension of labels that included
the proposed pictograms among 364
workers in four sectors in Zambia
(transport, agriculture, industrial, and
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household consumers) (Banda and
Sichilongo, 2006). Within this
population, the skull and crossbones
symbol was widely understood, as was
the ‘‘flame’’ symbol. Based on these
results, the authors suggest a preference
for symbols that depict familiar,
meaningful, and recognizable images.
London performed a similar study
among the same four sectors in South
Africa, finding that the skull and
crossbones was understood by at least
96 percent of each sector and ‘‘flame’’
by at least 89 percent (London, 2003).
‘‘Exploding bomb’’ was correctly
comprehended by 44 to 71 percent of
each sector. Many health-related
symbols did not fare well, and six
symbols had less than 50 percent
comprehension across all four sectors.
Outside the transport sector, ‘‘Gas
cylinder’’ was the least well
comprehended symbol.
These findings indicate that some of
the pictograms included in the proposed
rule are already widely recognized by a
general audience. Others, however, are
not commonly understood. Therefore,
simply adding some of the proposed
pictograms on labels will not provide
useful information unless efforts are
also undertaken to ensure that
employees understand the meaning of
the pictograms. As Wogalter et al. noted,
some studies have found slower
processing, poorer recognition, and
greater learning difficulties with
symbols versus with text—particularly
if the symbols are complex or nonintuitive (Wogalter et al., 2006). These
results emphasize the need to train
employees on the meaning of the
pictograms that would be included on
chemical labels.
Where pictograms are used and
understood, communication of hazards
can be improved. Houts et al. studied
long-term recall of spoken medical
instructions when accompanied by a
handout with pictograms (Houts et al.,
2001). Nearly 200 pictograms were
tested with 21 low-literate adults (less
than grade 5 reading level). Immediately
after training, participants recalled the
meaning of 85 percent of the
pictograms, and they recalled 71 percent
after 4 weeks. This study found that
recall was better for simple pictograms
where there is a direct relationship
between the image and its meaning—
that is, where no inference is required.
Another body of literature focuses on
the utility of symbols in general. Ganier
found that people generally construct
mental representations faster with
pictures than they do with text,
supporting earlier findings on the
usefulness of symbols (Ganier, 2001).
Evans et al. found similar results with
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a task in which undergraduates were
asked to sort items into categories using
either text clues, visual clues, or a
combination of pictures and text (Evans
et al., 2002). When categories were fixed
(i.e., sorting instructions were specific),
people sorted the cards more
consistently with one another when
presented with pictures than when
presented with text alone.
In a follow-up article on the South
African study mentioned previously,
Dowse and Ehlers found that patients
receiving antibiotics adhered to
instructions much better when the
instructions included pictograms (54
percent with high adherence, versus 2
percent when given text-only
instructions) (Dowse and Ehlers, 2005).
Pictograms also serve to attract
attention to the hazard warnings on a
label. To examine factors that influence
the effectiveness of pharmaceutical
labels, Kalsher et al. asked subjects to
rate the noticeability, ease of reading,
and overall appeal of labels with or
without pictorials (Kalsher et al., 1996).
A group of 84 undergraduates gave
consistently higher ratings to labels with
pictorials. A group of elderly subjects
had similar preferences, rating labels
with pictorials as significantly more
noticeable and likely to be read.
Laughery et al. found similar results
with a timed test on alcoholic beverage
labels (Laughery et al., 1993). When a
pictorial was present to the left of the
warning showing what not to do when
drinking, the amount of time it took to
find the label was significantly reduced.
An icon consisting of the alert symbol
(an exclamation mark set within a
triangle) and the signal word WARNING
also decreased response time. The
fastest response time came when four
different enhancements (including the
pictorial and the icon) were included. In
a follow-up exercise, an eye scan test
found that the pictorial had a
particularly strong influence on reaction
time, compared with other
enhancements.
As far as chemical labels are
concerned, London found that symbols
tend to be the most easily recalled label
elements (London, 2003). In the
comprehensibility test of labels among
South African workers mentioned
previously, symbols were the most
commonly recalled elements—
particularly the skull and crossbones—
and people recalled looking at symbols
first. Symbols were also cited as by far
the most important factor in
determining hazard perception. Overall,
the author concludes that ‘‘Symbols are
therefore key to attracting attention, and
informing risk perception regarding a
chemical.’’
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Wogalter et al. found less encouraging
evidence on pictorials, however
(Wogalter et al., 1993). The authors
tested the influence of various warning
variables on whether subjects wore
proper protective equipment during a
task involving measuring and mixing
chemicals. Warning location and the
amount of clutter around the warning
had significant effects on compliance,
but the presence or absence of pictorials
did not.
Meingast asked subjects to recall
warning content after viewing labels
that were considered either high quality
(with color signal icons, pictorials, and
organized text conforming to ANSI
Z535.4, the American National Standard
for Product Safety Signs and Labels) or
low quality (text only) (Meingast, 2001).
Pictorials were the items remembered
most often, accounting for 48 percent of
what viewers of high quality labels
recalled. The author suggests that these
pictorials also served the role of dual
coding, meaning that they help to
improve the retention of corresponding
text.
Other recent studies support this
dual-coding function of pictorials,
finding that symbols tend to be most
effective when paired with redundant or
reinforcing text. For example, Sojourner
and Wogalter asked 35 participants to
rate several prescription label formats in
terms of ease of reading, ease of
understanding, overall effectiveness,
likelihood of reading, overall
preference, pictorial understanding, and
how helpful pictorials are in helping to
remember the instructions (Sojourner
and Wogalter, 1997). The authors found
that people prefer fully redundant text
and pictorials, which they judged
easiest to read, most effective, and
preferred overall. Dual-coded pictorials
aided understanding and memory more
than labels with pictorials only (no
text). In a follow-up study, Sojourner
and Wogalter gave undergraduates,
young adults, and older adults a free
recall test after viewing medication
labels (Sojourner and Wogalter, 1998).
Fully redundant text and pictorials led
to significantly greater recall than other
formats, and were rated most effective
by all age groups.
Similarly, Sansgiry et al. found that
pictograms on over-the-counter drug
labels improved comprehension, but
only when they were congruent with the
corresponding text (Sansgiry et al.,
1997). A group of 96 adults were less
confused, more satisfied, more certain
about their knowledge, and understood
more when shown labels that contained
congruent pictures and verbal
instructions, versus verbal instructions
alone. The results were significantly
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better with congruent pictures and text
than with either pictures alone or
incongruent pictures and text.
Some evidence links use of
pictograms directly to safer behavior.
Jaynes and Boles investigated whether
different warning designs, specifically
those with symbols, affect compliance
rates (Jaynes and Boles, 1993). Five
conditions were tested: a verbal
warning, a pictograph warning with a
circle enclosing each graphic, a
pictograph warning with a triangle on
its vertex enclosing each graphic, a
warning with both words and
pictographs, and a control (no warning).
Participants performed a chemistry
laboratory task using a set of
instructions that contained one of the
five conditions. The warnings instructed
them to wear safety goggles, mask and
gloves. All four warning conditions had
significantly greater compliance than
the no-warning condition. A significant
effect was also found for the ‘‘presence
of pictographs’’ variable, suggesting that
the addition of pictographs will increase
compliance rates.
In addition to the evidence pertaining
to the other graphical elements in
pictograms, research indicates that the
use of the color red in pictograms will
serve to make warnings more noticeable.
Red is also generally perceived to reflect
the greatest degree of hazard, and is thus
well-suited to identifying serious
chemical hazards in the workplace.
In their review of the literature on
warning effectiveness on behavioral
compliance, Kalsher and Williams
summarize several studies that
examined the effects of adding color to
warnings (Kalsher and Williams, 2006).
Overall, Kalsher and Williams suggest
that adding color can influence both the
noticeability and effectiveness of
warnings.
In a test on the noticeability of
warnings, Swindell measured the
amount of time it took subjects to locate
warning text that had been embedded in
medication instructions (Swindell,
1999). Warnings were found
significantly faster when the icon and
signal word were presented in either red
or blue, causing the warning to stand
out from the black text. Swindell’s
findings echo the results reported by
Laughery et al., who found that
alcoholic beverage labels were located
significantly faster when the text was
red instead of black (Laughery et al.,
1993). While these studies involve color
on label elements other than the
pictogram border, they provide a general
indication that color attracts the
attention of label users.
A number of researchers have
investigated the hazard connotations of
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different colors. These investigations
indicate that red is generally perceived
to reflect the greatest degree of hazard.
Yellow, orange, and black reflect a
lesser degree of hazard. In a review of
the literature, Parsons et al. suggest that
the red-orange-yellow hierarchy
generally matches people’s perceptions
of risk, including perceptions among
native Spanish speakers (Parsons et al.,
1999). Experimental results that support
the conclusion that red generally
connotes the highest degree of hazard
include:
› Smith-Jackson and Wogalter asked
English-speaking community members
to rate the perceived hazard of ten ANSI
safety colors (Smith-Jackson and
Wogalter, 2000). Red, yellow, black, and
orange were rated the highest (in
descending order). Differences were
statistically significant except the
difference between yellow and black.
› Among 80 college students asked
to rate colors by Griffith and Leonard,
red was rated the most ‘‘meaningful’’
color (i.e., most distinct in meaning
from neutral gray), followed by green,
orange, black, white, blue, and yellow
(Griffith and Leonard, 1997).
› Wogalter et al. asked Spanish
speakers to rank the perceived hazard of
ANSI safety colors (Wogalter et al.,
1997b). Red was ranked highest,
followed by orange, black, and yellow.
› Dunlap et al. surveyed 1169
subjects across several different
language groups including English,
German, and Spanish speakers (Dunlap
et al., 1986). Subjects rated the color
words red, orange, yellow, blue, green,
and white according to the level of
perceived hazard. The results
demonstrated that the hazard
information communicated by different
colors followed a consistent pattern
across language groups, with red having
the highest hazard ratings.
› Wogalter et al. asked
undergraduates and community
volunteers to rank various warning
components (Wogalter et al., 1998). Red
connoted a significantly greater hazard
than other colors, followed by yellow,
orange, and black (in that order). A
group of industrial workers ranked the
colors from greatest to least hazard as
follows: red, yellow, black, orange.
› London asked workers in four
sectors in South Africa to rank the
colors red, yellow, green, and blue in
terns of perceived hazard; 95 percent
said red represents the greatest hazard,
and 58 percent said yellow is the second
greatest hazard (London, 2003).
› Banda and Sichilongo asked
workers in Zambia to rate the perceived
hazard of various colors used in
chemical labels (Banda and Sichilongo,
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2006). Red was associated with the
greatest hazard, followed by yellow.
› Among a sample of 30
undergraduates who rated the perceived
hazard of 105 signal word/color
combinations, Braun et al. reported that
red conveyed the highest level of
perceived hazard followed by orange,
black, green, and blue (Braun et al.,
1994).
These reports are consistent in
indicating that red is commonly
understood to be associated with a high
level of hazard—the highest of any
color. OSHA anticipates that by using
the color red on labels for hazardous
chemicals, labels will be more effective
in communicating hazards to
employees—both by drawing the
attention of employees and indicating
the presence of a hazard through nonverbal means.
Hazard and Precautionary Statements
Hazard statements describe the
hazards associated with a chemical.
Precautionary statements describe
recommended measures that should be
taken to protect against hazardous
exposures, or improper storage or
handling of a chemical. The HCS
currently includes a performanceoriented requirement for ‘‘appropriate
hazard warnings’’ on labels. The
proposed rule would require specific
hazard statements and precautionary
statements on labels. The statements
would be determined based on the
hazard classification of the chemical.
Standardized requirements for hazard
and precautionary statements would
provide a degree of consistency that is
currently lacking among chemical
labels. This lack of consistency makes it
difficult in some instances for users to
understand the nature and degree of
hazard associated with a chemical, and
to compare chemical hazards. For
example, Beach relates experiences from
the perspective of a doctor treating
occupationally exposed patients (Beach,
2002). The author noted that different
suppliers use different risk phrases for
the same chemical, making it difficult
for users to compare relative risks.
ANSI standard Z129.1 was developed
to provide a consistent approach to
labeling of hazardous chemicals. This
standard gives manufacturers and
importers guidance on how to provide
information on a label, including
standardized phrases and other
information that can improve the
quality of labels. Because it is a
voluntary standard, however, the ANSI
approach has not been adopted by all
chemical manufacturers and importers.
As a result of the diverse formats and
language used, consistent and
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understandable presentation of
information has not been fully achieved.
A preference for hazard statements
was shown in EPA’s Consumer Labeling
Initiative (Abt Associates, 1999). This
study asked consumers about their
attitudes toward labels on household
chemical products. Overall, consumers
indicated that they like to have
information that clearly connects
consequences with actions, and they
prefer to know why they are being
instructed to take a particular
precaution. A clear hazard statement
can provide this information.
In some cases, clear and concise
precautionary information is necessary
to enable employees to identify
appropriate protective measures. For
example, Frantz et al. examined the
impact of flame and poison warning
symbols prescribed in certain
regulations by the Canadian government
(Frantz et al., 1994). The results suggest
that although the generic meanings of
these two symbols are well understood,
people may have difficulty inferring the
specific safety precautions necessary for
a particular product.
Other reports have indicated that
users prefer information that includes
both an indication of the hazard and the
recommended action (i.e., the
precautionary statement). Braun et al.
examined statements in product
instructions for a pool treatment
chemical and a polyvinyl chloride
(PVC) adhesive, asking subjects to rate
the injury risk posed by each product
(Braun et al., 1995). The experimenters
manipulated the instructions to include
either recommended actions only,
actions followed by consequences,
consequences followed by actions, or a
simple restatement of the product label.
The authors found that actions paired
with consequences led to significantly
higher risk perception than a
restatement of the label or actions alone.
Although the preferred wording was
longer than the alternatives, subjects did
not feel that the instructions were too
complex, suggesting that they appreciate
having actions and consequences paired
together. Freeman echoed these findings
in a discussion on communicating
health risks to fishermen and farmers,
noting that to be useful, risk statements
should be balanced with equally strong
statements of ways to reduce or avoid
the risk (Freeman, 2001).
Explicit precautionary statements may
make it more likely that employees will
take appropriate precautions. Bowles et
al. asked subjects to review product
warnings, then either decide what
actions they should take or evaluate
whether someone else’s actions were
safe, based on the warning (Bowles et
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al., 2002). In general, situations that
required the user to make inferences
about a hazard—particularly when they
had to come up with their own ideas for
protective actions—led to decreased
intent to comply. By providing clear
precautionary instructions on the label,
the proposed rule would eliminate the
need for users to infer protective
actions.
Some evidence indicates that using
key label elements together can improve
warning performance, compared with
labels that only contain a subset of these
elements. This is the approach taken in
the proposed rule, which would require
the signal word, pictogram(s), hazard
statement(s), and precautionary
statement(s) together on the label. In one
study, Meingast asked students to recall
information from two variations of
warning labels: enhanced warnings with
color, signal icons, pictorials, and
organized text (following the ANSI
Z535.4 standard); and warnings with
text only (Meingast, 2001). The authors
reported that the enhanced warnings
were more noticeable, led to
significantly greater recall, and made
people report a higher likelihood of
compliance.
Other findings agree that improving
all label elements can improve warning
performance. For example, Lehto tested
information retrieval from three
chemical label formats and found that
subjects generally did best with an
‘‘extensive’’ format that included
pictograms, paragraphs, and horizontal
bars indicating the degree of hazard
(Lehto, 1998). Subjects were able to
answer more questions correctly when
the label included a range of content—
particularly information on first aid and
spill procedures.
Wogalter et al. reported similar results
in a test of four different signs that
discouraged people from using an
elevator for short trips (Wogalter et al.,
1997a). Three signs were text-only. The
fourth sign had a signal word panel,
icons, a pictorial, and more explicit
wording indicating the desired behavior
(i.e., ‘‘use the stairs’’). Subjects rated the
enhanced sign as more understandable,
and a field test found that it
significantly increased compliance over
the other options.
The effectiveness of a combination of
elements was also investigated in a
study of warnings on alcoholic beverage
containers (Laughery et al., 1993).
Laughery et al. tested warnings to
determine which elements influenced
noticeability. The authors manipulated
labels by adding a pictorial, adding an
alert symbol with a signal word, making
the text red, and/or adding a border
around the warning. The warning was
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located fastest when all four of these
modifications were present, suggesting
that the best designs include a
combination of enhancements.
These findings support the belief that
the proposed label elements, in
combination, would likely be more
effective in communicating hazard
information than the individual
elements would be if presented alone.
Although the warnings examined in
these studies are different than those
included in the proposed rule, they
indicate that enhancements such as
color and symbols can increase the
effectiveness of a label, and that
presenting hazard information and
corresponding precautions together may
improve understanding. OSHA therefore
believes that this evidence substantiates
its belief that the proposed labeling
requirements will result in more
effective transmittal of information to
employees.
Overall, the presentation of
information on labels through
standardized signal words, hazard
statements, pictograms, and
precautionary statements would provide
clearer, more consistent, and more
complete information to chemical users.
Comments received in response to the
ANPR support this view (e.g., Document
ID #s 0054, 0032, 0124, 0124, and 0158).
For example, the Refractory Ceramic
Fibers Coalition (Document ID #0030)
pointed to the benefits of this approach,
stating:
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Employers and employees would be given
the same information on a chemical
regardless of the supplier. This consistency
should improve communication of the
hazards. It may also improve communication
for those who are not functionally literate, or
who are not literate in the language written
on the label. In addition, having the core
information developed already, translated
into multiple languages, and readily available
to whomever wishes to access it, should
eliminate the burden on manufacturers and
users to develop and maintain their own
such systems. Thus the specification
approach should be beneficial both to the
producers and the users of chemicals.
Labels are intended to provide an
immediate visual reminder of chemical
hazards. Whereas labels currently may
be presented in a variety of formats
using inconsistent terminology and
visual elements, labels prepared in
accordance with the proposed
requirements would be consistent.
Standardized signal words and hazard
statements would attract attention and
communicate the degree of hazard.
Pictograms would reinforce the message
presented in text and enhance
communication for low-literacy
populations. Precautionary statements
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would provide useful instructions for
protecting against chemical-source
injuries and illnesses.
Safety Data Sheets
The HCS requires chemical
manufacturers and importers to develop
an SDS for each hazardous chemical
they produce or import. SDSs serve as
a source of detailed information on
chemical hazards and protective
measures. Each SDS must indicate the
identity of the chemical used on the
label; the chemical and common
name(s) of hazardous ingredients;
physical and chemical characteristics;
physical and health hazards; the
primary route(s) of entry; exposure
limits; generally applicable precautions
for safe handling and use; generally
applicable control measures; emergency
and first aid procedures; the date of
preparation of the SDS; and the name,
address and telephone number of the
party preparing or distributing the SDS.
The HCS does not require this
information to be presented in any
particular order or to follow a specific
format.
Since the HCS was adopted in 1983,
access to chemical information has
improved dramatically due to the
availability of SDSs. While the
effectiveness of SDSs is evident, there
are concerns regarding the quality of
information provided. In particular,
concerns have been raised regarding the
accuracy (i.e., the correctness and
completeness of the information
provided) and comprehensibility (i.e.,
the ability of users to understand the
information presented) of information
provided on SDSs.
OSHA is proposing a requirement that
the information on SDSs be presented
using consistent headings in the
sequence specified in the GHS (see
Section XV for a detailed discussion of
the proposed requirements). The
Agency believes that a standardized
order of information would improve the
utility of SDSs by making it easier for
users to locate and understand the
information they are seeking. A
standardized format would also be
expected to improve the accuracy of the
information presented on SDSs.
A number of studies have
demonstrated the benefits provided by
SDSs. In May 1992, the General
Accounting Office (GAO) issued a report
presenting the findings of an
examination of difficulties small
employers were said to experience in
complying with the HCS, as well as
issues relating to the costs of
compliance (GAO, 1992). The findings
were based on the results of a national
survey of construction, manufacturing,
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and personal services providers. A total
of 1,120 responses were received from
employers.
One very important finding of the
GAO survey was that almost 30% of
employers reported that they had
replaced a hazardous chemical with a
less hazardous substitute because of
information presented on an SDS. With
regard to the HCS as a whole, GAO
found that over 56% of employers
reported ‘‘great’’ or ‘‘very great’’
improvement in the availability of
hazard information in the workplace
and in management’s awareness of
workplace hazards. Forty-five percent of
those in compliance with the HCS
considered the standard to have a
positive effect on employees, compared
with only 9% who viewed the effect as
negative. The results indicate that when
chemical hazard information is
provided, the result is generally
recognized as beneficial to employees.
A number of other studies support
this conclusion. For example, in a
survey of 160 workers at a large national
laboratory, more than 90 percent of
respondents said that SDSs are
satisfactory or very satisfactory in
providing protective information and
answering questions (Phillips et al.,
1999).
Conklin demonstrated the utility of
SDSs among employees of a
multinational petrochemical company
(Conklin, 2003). Across three countries
(the U.S., Canada, and the United
Kingdom), 98 percent felt that the SDS
is a satisfactory information source (the
percentage was similar across all three
countries). Seventy-two percent said
they would request an SDS all or most
of the time when introduced to a new
chemical, although 46 percent of
workers said that SDSs are too long. The
author notes, however, that this sample
did not include any workers with low
literacy.
A number of investigations have
raised concerns that, in some cases, the
information on SDSs is not
comprehensible to employees. In 1991,
OSHA commissioned a study that
evaluated the comprehensibility of SDSs
by a group of unionized employees in
manufacturing industries located in the
State of Maryland (Kearney/Centaur,
1991). The study assessed the ability of
these employees to understand
information regarding the route of entry
of the substance, the type of health
hazard present, appropriate protective
measures, and sources of additional
help.
Each of the 91 participating workers
was provided with and tested on four
different SDSs. The workers answered
the test questions based on information
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supplied on each of the SDSs. It should
be noted that the employees who
volunteered for this study understood
that it relied on reading comprehension.
This created a selection bias, as
employees with reading difficulties
would not be likely to volunteer for the
study.
The results of the tests indicated that
workers on average understood about
two-thirds of the health and safety
information on the SDSs. The best
comprehension was associated with
information providing straightforward
procedures to follow (e.g., in furnishing
first aid, dealing with a fire, or in using
personal protective equipment) or
descriptions of how a chemical
substance can enter the body. Workers
had greater difficulty understanding
health information addressing different
target organs, particularly when more
technical language was used. Workers
also reportedly had difficulty
distinguishing acute from chronic
effects based on information presented
in the SDSs.
A similar result was reported by
Conklin in a study involving employees
of a multinational petrochemical
company (Conklin, 2003). After viewing
information on an unfamiliar chemical
in a variety of SDS formats, a
questionnaire was administered to
workers to gauge their comprehension
of the material presented. The workers
reportedly answered 65 percent of the
questions correctly.
A study that examined the
comprehensibility of SDS to master
printers was reported by the Printing
Industries of America in 1990 (PIA,
1990). The subjects had an average of
13.9 years of formal education, or
approximately two years beyond high
school. In this study, 27 SDSs were
selected and analyzed for reading levels
using a software program, finding an
average reading grade level of 14. The
investigators found that employees with
15 years of education or more
understood 66.2% of the information
presented.
Some of the difficulty workers
experience in understanding
information presented on SDSs may be
due to the vocabulary used in the
document. Information presented at a
reading level that exceeds the capability
of the user is unlikely to be well
understood. An example of this
situation was reported by Frazier et al.
(Frazier et al., 2001). The authors
evaluated a sample of SDSs from 30
manufacturers of toluene diisocyanate, a
chemical known to cause asthma. Half
of the SDSs indicated that asthma was
a potential health effect. One SDS made
no mention of any respiratory effects,
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while others used language (e.g., allergic
respiratory sensitization) that the
authors believed may not clearly
communicate that asthma is a risk.
However, the more technical language
meets the requirements of the HCS.
Other reports substantiate the belief
that many SDS users have difficulty
understanding the information on the
documents. For example, in a study
evaluating the comprehensibility of
SDSs at a large research laboratory, 39
percent of the workers found SDSs
‘‘difficult to understand’’ (Phillips,
1997). The study also indicated that a
third of the information provided on
SDSs was not understood. These results
were obtained from a study population
of literate, trained workers who spoke
English as their first language.
Smith-Jackson and Wogalter
corroborated this finding in a study
involving 60 undergraduates and
community volunteers (Smith-Jackson
and Wogalter, 1998). The subjects were
asked to sort SDS data into a logical
order. After completing the task,
subjects were asked for their opinions
on the difficulty of the content. Overall,
43 percent found the information easy
to understand, 42 percent said it was
not easy, and the remaining 15 percent
felt that only scientists, experts, or very
experienced workers would be able to
understand the information.
These studies are consistent in
reporting that workers have difficulty
understanding a substantial portion of
the information presented on SDSs. This
finding can be explained at least in part
by the fact that not all of the information
on SDSs is intended for workers. SDSs
are intended to provide detailed
technical information on a hazardous
chemical. While they serve as a
reference source for exposed employees,
SDSs are also meant for other audiences
as well. SDSs provide information for
the benefit of emergency responders,
industrial hygienists, safety
professionals, and health care providers.
Much of this information may be of a
technical nature and would not be
readily understood by individuals who
do not have training or experience in
these areas. For example, language that
may be readily understood by a
population of firefighters may be poorly
understood by chemical workers.
In addition, Title III of the Superfund
Amendments and Reauthorization Act
(SARA, also known as the Emergency
Response and Community Right-toKnow Act of 1986) mandated that SDSs
be made available to State emergency
response commissions, local emergency
planning committees, and fire
departments in order to assist in
planning and response to emergencies,
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50299
as well as to provide members of the
general public with information about
chemicals used in their communities. It
is difficult, if not impossible, for a
document to meet the informational
needs of all of these audiences while
being comprehensible to all as well.
Product liability concerns also play a
role in the comprehensibility of SDSs.
Producers of chemicals may be subject
to ‘‘failure to warn’’ lawsuits that can
have significant financial implications.
Attempts to protect themselves against
lawsuits can affect the length and
complexity of SDSs, as well as the way
in which information is presented.
In some cases the length and
complexity of SDSs reportedly make it
difficult to locate desired information
on the documents. For example, in
testimony before the U.S. Senate
Subcommittee on Employment, Safety,
and Training, one hospital safety
director described a situation in which
an employee was unable to find critical
information on an SDS in an emergency
situation:
* * * two gallons of the chemical xylene
spilled in the lab of my hospital. By the time
an employee had noticed the spill, the
ventilation had already sucked most of the
vapors into the HVAC. This, in turn, became
suspended in the ceiling tile over our
radiology department. Twelve employees
were sent to the emergency room. To make
the matter worse, the lab employee was
frantically searching through the MSDS
binder in her area for the xylene MSDS. Once
she found it, she had difficulty locating the
spill response section. After notifying our
engineering department, she began to clean
up the spill with solid waste rags, known for
spontaneous combustion, and placing the
rags into a clear plastic bag for disposal. She
did not know that xylene has a flash point
of 75 degrees Fahrenheit. She then walked
the bag down to our incinerator room and left
it there, basically creating a live bomb.
Twelve people were treated from this
exposure. The lab employee was very upset
and concerned about the safety of the
affected employees and visitors, and
hysterically kept stating that she could not
find the necessary spill response information
(Hanson, 2004).
SDSs at this particular hospital were
reported to range from one page to 65
pages in length.
To accommodate the needs of the
diverse groups who rely on SDSs, a
standardized format has been viewed as
a way to make the information on SDSs
easier for users to find, and to segregate
technical sections of the document from
more basic elements. A standardized
format was also thought to facilitate
computerized information retrieval
systems and to simplify employee
training.
OSHA established a voluntary format
for SDSs in 1985 to assist manufacturers
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and importers who desired some
guidance in organizing SDS
information. This 2-page form (OSHA
Form 174) includes spaces for each of
the items included in the SDS
requirements of the standard, to be
filled in with the appropriate
information as determined by the
manufacturer or importer. However,
some members of the regulated
community desired a more
comprehensive, structured approach for
developing clear, complete, and
consistent SDSs.
In order to develop this structure, the
Chemical Manufacturers Association
(now known as the American Chemistry
Council) formed a committee to
establish guidelines for the preparation
of SDSs. This effort resulted in the
development of American National
Standards Institute (ANSI) standard
Z400.1, a voluntary consensus standard
for the preparation of SDSs. Employers,
workers, health care professionals,
emergency responders, and other SDS
users participated in the development
process. The standard established a 16section format for presenting
information as well as standardized
headings for sections of the SDS. An
updated version of the ANSI standard
published in 2004 is consistent with the
GHS format that is included in the
proposed rule.
By following the recommended
format, the information of greatest
concern to employees is featured at the
beginning of the document, including
information on ingredients and first aid
measures. More technical information
that addresses topics such as the
physical and chemical properties of the
material and toxicological data appears
later in the document. The ANSI
standard also includes guidance on the
appearance and reading level of the text
in order to provide a document that can
be easily understood by readers.
OSHA currently allows the ANSI
format to be used as long as the SDS
includes all of the information required
by the HCS. Because it is a voluntary
standard, however, the ANSI format has
not been adopted by all chemical
manufacturers and importers. As a
result, different formats are still used on
many SDSs.
The International Organization for
Standardization (ISO) has published its
own standard for SDS preparation. This
standard, ISO 11014–1, has been revised
for consistency with the GHS (new
version issued in 2009). The standard
includes the same 16 sections as the
GHS, as well as similar data
requirements in each section. These two
consensus standards, ANSI Z400.1–
2004 and ISO 11014–1 (2009), have
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essentially the same provisions and are
consistent with GHS. There are minor
differences, such as units of measure
recommended in the national ANSI
standard versus the international ISO
standard.
Another development has been the
creation of International Chemical
Safety Cards (ICSCs). The documents,
developed by the International
Programme on Chemical Safety,
summarize essential health and safety
information on chemicals for use at the
‘‘shop floor’’ level by workers and
employers (Niemeier, 1997). ICSCs are
intended to present information in a
concise and simple manner, and they
follow a standardized format that is
shorter (one double-sided page) and less
complex than the ANSI approach. The
ICSCs were field tested in their initial
stages of development, and new ICSCs
are verified and peer reviewed by
internationally recognized experts
(Niemeier, 1997). ICSCs have been
developed in English for 1,646
chemicals, and are also available in 16
other languages. The ICSCs are being
updated to be consistent with the GHS.
A study by Phillips compared the
effectiveness of different SDS formats as
well as ICSCs among workers at a large
national laboratory (Phillips, 1997). The
employees represented a variety of
trades, including painters, carpenters,
truck drivers, and general laborers. Each
worker was tested for knowledge
regarding a hazardous chemical before
and after viewing an SDS or ICSC. Three
designs were tested: a 9-section OSHA
form, the 16-section ANSI Z400.1 format
(an earlier and slightly different version
of the current ANSI Z400.1 format), and
the 9-section ICSC. A subsequent paper
described the final results of this study
(Phillips, 1999). All three formats led to
significant improvements in subjects’
knowledge, and there was no
statistically significant difference among
the three formats in terms of total test
score. However, there were a few
significant differences in how well
readers of each SDS format answered
specific types of questions:
• The ICSC performed better than the
OSHA form regarding chronic and
immediate health effects.
• The other two formats performed
better than the ANSI format on firerelated questions.
• The OSHA form performed better
than the other two formats on spill
response questions.
• The OSHA form was better than the
ANSI format regarding carcinogenic
potential.
In a separate comparison, Conklin
also found similarities in the overall
performance of several standard SDS
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formats (Conklin, 2003). In this study,
employees of a multinational
petrochemical company were given one
of three versions of an SDS for an
unfamiliar chemical: a U.S. version
(OSHA’s required content within an
ANSI Z400.1–1998 16-part structure); a
Canadian version following the 9-part
structure prescribed by Canada’s
Workplace Hazardous Materials
Information System (WHMIS); and a
version following the European Union’s
content and 16-part structure. SDSs
were controlled for font, layout, and
reading level. Overall, Conklin found no
statistically significant difference in
mean post-test scores using the three
different formats, although there were
significant differences on 5 out of 10
questions (no one format was
consistently better).
Because extensive searching can be a
barrier to SDS use, researchers have
examined whether there is a preferred
order of information that more closely
matches users’ cognitive expectations.
Smith-Jackson and Wogalter asked 60
undergraduates and community
volunteers to arrange portions of six
SDSs in the order they considered most
usable (Smith-Jackson and Wogalter,
1998). The authors found a few
consistent results:
• Information about health hazards,
protective equipment, and fire and
explosion data tended to be placed
toward the beginning.
• Physical and reactivity data tended
to be placed near the end.
• Spill or leak procedures were
placed near the beginning or the middle,
depending on the type of chemical.
A majority of subjects reported that
they had attempted to prioritize the
hazard information that needed to be
communicated. The participants’
suggested order of information generally
did not match either the original SDS
order or the order listed in the HCS—
particularly the subjects’ emphasis on
health hazard information near the
beginning.
In the previously discussed 1991
study that evaluated the
comprehensibility of SDSs by a group of
91 unionized workers in manufacturing
industries in the State of Maryland, a
subset of the group (18 workers) was
also tested on an ICSC (Kearney/Centaur
1991). While the results indicated that
workers on average understood about
two-thirds of the health and safety
information on SDSs, ICSCs provided
better results. The average ICSC test
score ranged from 6% to 23% higher
than the average test score on the four
SDSs evaluated. This finding was
considered by the authors to suggest
that an improved format for SDSs may
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serve to increase user comprehension of
the information presented.
OSHA believes that a standardized
format would improve the effectiveness
of SDSs. The primary basis for this
belief is very simple: A consistent
format would make it easier for users to
find information on an SDS. Headings
for SDS sections would be standardized,
so SDS users would know which section
to consult for the information they
desire. The sections would be presented
in a consistent, logical sequence to
further facilitate locating information of
interest. Information commonly desired
by exposed employees and of greatest
interest to emergency responders (e.g.,
Hazards Identification; First Aid
Measures) would be presented in the
beginning of the document for easy
reference. More technical information
(e.g., Stability and Reactivity;
Toxicological Information) would be
presented later.
By segregating more complex
information on an SDS from the
information that is generally easier to
understand, the standardized format
included in the proposed rule has the
potential to address many of the
concerns that have been raised
regarding the comprehensibility of
information on SDSs. The standardized
order of information will allow SDS
users who desire only basic information
about a hazardous chemical to find that
information without having to sift
through a great deal of technical
information that may have little
meaning to them. In emergency
situations, rapid access to information
such as first-aid measures, fire-fighting
measures, and accidental release
measures can be critically important.
A standardized format does not
address all issues affecting SDS
comprehensibility. Reading level and
some design elements would continue
to vary. In many respects, this is
inevitable given the different target
audiences that SDSs have, and the
varying qualifications of those who
prepare SDSs. Nevertheless, OSHA
believes that the proposed revisions will
result in a substantial improvement in
the quality and ease of comprehension
of information provided on SDSs.
In addition to the issues regarding
comprehensibility, a number of
researchers have raised concerns that
some SDSs may be incomplete or
contain erroneous information. The
magnitude of the problem is unclear,
because only very limited numbers of
SDSs have been evaluated in these
studies and in some cases the
investigations were performed so long
ago that the results may not reflect
current practices. Nevertheless, the
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evidence appears to indicate that a
substantial number of SDSs may not
contain complete and correct
information.
An initial examination of the accuracy
of SDSs was commissioned by OSHA
shortly after the scope of the rule was
expanded to cover all industries in 1987
(Karstadt, 1988). The report, which
analyzed the content of 196 SDSs for
products used in auto repair and body
shops, provided a general indication
that the content and presentation of
information was inconsistent on the
SDSs examined. In 1991, OSHA
commissioned an additional study that
examined the accuracy of SDSs
(Kearnet/Centaur, 1991). The study
examined information presented in five
areas considered crucial to the health of
workers potentially exposed to
hazardous substances. These five areas
assessed were chemical identification of
ingredients; reported health effects of
ingredients; recommended first aid
procedures; use of personal protective
equipment; and exposure level
regulations and guidelines. The
evaluation indicated that 37% of the
SDSs examined accurately identified
health effects data, 76% provided
complete and correct first aid
procedures, 47% accurately identified
proper personal protective equipment,
and 47% correctly noted all relevant
occupational exposure limits. Only 11%
of the SDSs were accurate in all four
information areas, but more (51%) were
judged accurate, or considered to
include both accurate and partially
accurate information, than were judged
inaccurate (10%). The study also
concluded that the more recent SDSs
examined (those prepared between 1988
and 1990) appeared to be more accurate
than those prepared earlier.
This belief that some SDSs are not
complete and correct was corroborated
by an examination of SDSs for lead and
ethylene glycol ethers (Paul and Kurtz,
1994). Although these substances are
known reproductive and developmental
toxicants, researchers found that 421 of
678 SDSs examined (62%) made no
mention of effects on the reproductive
system. OSHA also commissioned a
study, completed in 1999, focusing
specifically on the accuracy of first aid
information provided on SDSs
(Lexington Group, 1999). A total of 56
SDSs for seven chemicals were
examined. First aid information on the
SDSs was compared with information
from established references. The
researchers reported that nearly all of
the SDSs reviewed had at least minor
inaccuracies.
A standardized format does not
directly address the concerns that have
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been raised regarding the accuracy of
information present on SDSs. However,
standardization would improve the
accuracy of chemical hazard
information indirectly. With consistent
presentation of information, the task of
reviewing SDSs and labels to assure
accuracy would be simplified.
Individuals preparing and reviewing
these documents should find it easier to
identify any missing elements, and
compare information presented on an
SDS to reference sources and other
SDSs. OSHA enforcement personnel
would be able to more efficiently
examine SDSs when conducting
inspections. The detailed entries
proposed for the SDS are particularly
noteworthy in this regard. The subheadings would provide an organized
and detailed list of pertinent
information to be included under the
headings on the SDS. For example,
while the HCS currently requires
physical and chemical characteristics of
a hazardous chemical to be included on
the SDS, the proposed rule would
provide a list of 18 properties for
Section 9 of the SDS. The party
preparing the SDS would either include
the relevant information for these
entries, or indicate that the information
is not available or not applicable. This
approach would provide both a
reminder to the party preparing the SDS
regarding the information required, and
a convenient means of reviewing the
section to ensure that relevant
information is included and is accurate.
OSHA anticipates that the
classification criteria included in the
proposed rule would also improve the
accuracy and precision of information
on SDSs. The detailed criteria provided
would direct evaluators to the
appropriate classification for a
chemical. For example, while directing
the evaluator to use expert judgment in
taking all existing hazard information
into account, the criteria for serious eye
damage/eye irritation is tied to specific
results found in animal testing. In
addition, assignment to hazard
categories would lead to provision of
detailed information that would be
specific to the degree of hazard
presented by the chemical.
Classification of hazards would also
play an important role in increasing the
usefulness of SDSs under the proposed
rule. By including the classification of
the substance on the SDS, employers
would be in a much better position to
compare the hazards of different
chemicals. Hazard categories generally
give an indication of the severity of the
hazard associated with a chemical. For
example, all other things being equal, a
chemical classified for skin corrosion/
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irritation in category 1 as a skin
corrosive would be more hazardous
than a chemical classified in category 2
as a skin irritant. If chemicals are
classified into hazard categories, this
information can be used to simplify the
process of comparing chemicals. As
noted previously, employers use SDSs
as a means of comparing chemical
hazards to select less hazardous
alternatives. Thus it is reasonable to
believe that the proposed rule would
result in more effective use of the SDS
as an instrument for identifying less
hazardous substitutes for hazardous
chemicals.
Support for a standard SDS format has
been expressed consistently by a variety
of stakeholders for a long period of time.
The development of an industry
consensus standard for preparation of
SDSs, ANSI Z400.1, in itself, shows a
desire on the part of many parties for a
consistent approach to SDSs. As noted
previously, ANSI Z400.1 was updated
in 2004 to include the same sections
and sequence as the proposed rule.
Responses to OSHA’s Request for
Information in the Federal Register of
May 17, 1990 (55 FR 20580) indicated
widespread support for a standard SDS
format, with many specifically
supporting the ANSI format.
In its report of its evaluation of the
HCS, the GAO included several
recommendations. Among these was a
recommendation that OSHA clearly
specify the language and presentation of
information on SDSs (GAO, 1991). In
addition, the report of the National
Advisory Committee for Occupational
Safety and Health Review of Hazard
Communication (September 12, 1996)
indicated that during the public
presentations and workgroup
discussions, there was general
agreement that a uniform format should
be encouraged and most workgroup
members agreed that OSHA should
endorse use of the ANSI Z400.1 format
(NACOSH, 1996).
Comments received in response to the
ANPR also indicate widespread support
for a standard format for SDS (e.g.,
Document ID #s 0054, 0064, 0030, 0124,
and 0158). The American Foundry
Society, for example, said that
consistent SDSs make it easier for users
to find information and compare
products (Document ID #0158). The
Jefferson County Local Emergency
Planning Committee maintained that
critical information can be missed by
first responders due to the current lack
of consistency in presentation of
information on SDSs, stating: ‘‘It is not
overreaching for us to say that lives will
be saved through harmonization’’
(Document ID #0037). Based on the
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information in the record, OSHA thus
believes not only that the proposed
standardized SDS format would
improve the quality of information
provided on SDSs, but that stakeholders
generally prefer a standardized format.
Training
Along with labels on containers and
SDSs, employee training is one of three
core components of a comprehensive
hazard communication program.
Training is needed to explain and
reinforce the information presented on
labels and SDSs, to ensure that
employees understand the chemical
hazards in their workplace and are
aware of the protective measures to
follow. The proposed rule includes a
relatively minor revision to the HCS
training requirements, intended to
ensure that labels and SDSs are
adequately explained to employees (see
Section XV for a detailed discussion of
the proposed requirements). In light of
the evidence previously discussed
relating to label and SDS
comprehension, the importance of
training should not be underestimated.
Training is necessary to ensure that
employees understand the standardized
heading and sequence of information on
SDSs. Likewise, employees must be able
to understand the meaning of the
proposed standardized label elements in
order for them to be effective. In certain
instances, label elements already appear
to be fairly well understood. For
example, ‘‘Danger’’ already appears to
be generally recognized to represent a
higher degree of hazard than
‘‘Warning’’. Other label elements,
particularly some pictograms, are less
well understood. This finding is not
surprising given the limited amount of
exposure that most of the population
has had to these pictograms.
A relatively high level of
understanding is generally
recommended for pictograms. For
example, ANSI Z535.3, the American
National Standard that addresses
criteria for safety symbols, contains a
test method for determining the
effectiveness of a pictogram. The
criterion for success is 85% correct
responses, with no more than 5%
critical confusion. (Critical confusion
refers to when the message conveyed is
the opposite of the intended message.)
A score below 85% does not mean the
pictogram should not be used, but rather
that it should not be used without some
additional element, such as written text.
The International Standards
Organization has similar criteria in ISO
9186, Procedures for the Development
and Testing of Public Information
Symbols. This standard recommends
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testing methodologies to evaluate
symbols intended to be used
internationally. It sets a somewhat lower
level of acceptability (66%) than the
ANSI standard.
While initial understanding of some
pictograms may not be satisfactory,
research shows that training can
improve comprehension. In one study,
Wogalter et al. tested how well
undergraduate subjects comprehended a
set of 40 pharmaceutical and industrial
safety pictorials before and after training
(Wogalter et al., 1997c). Training led to
a significant increase in pictorial
comprehension. The improvement was
greatest for the most complex symbols.
Training was equally effective whether
the subject was given a simple printed
label (e.g., ‘‘Danger, cancer-causing
substance’’) or a label with additional
explanatory text.
Lesch conducted a similar study,
testing how well workers recognized a
set of 31 chemical and physical safety
symbols before and after training (Lesch,
2002; 2003). Training significantly
improved comprehension, which
remained higher up to 8 weeks later. As
in the Wogalter et al. study described
above, Lesch found little difference in
performance whether training took the
form of a written label assigned to each
symbol, a label plus explanatory text, or
an accident scenario. Training also
improved response speed.
In a survey of South African workers,
London examined the impact of brief
training on the meaning of symbols and
hazard phrases (London, 2003). Here,
the author found no statistical
difference in comprehensibility of four
familiar hazard symbols, but did find
that training improved comprehension
of one symbol (the proposed health
hazard symbol), and it also reduced the
overall incidence of critical confusion.
This study also found that workers with
previous workplace training were more
likely to understand label text and some
pictograms, and were better able to
identify the active ingredient. A similar
result was reported by Banda and
Sichilongo in their evaluation of GHS
labels in Zambia. The authors found
that ‘‘correct responses to label elements
were not a result of social class and/or
age but appeared to be influenced by
extent of duration of exposure either
through specialized training or
acquaintance’’ (Banda and Sichilongo,
2006). Recognizing that symbols are the
items most often recalled from a label,
London advised a strong emphasis on
training for GHS symbols, particularly
the ‘‘flame over circle’’ and ‘‘flame’’
symbols—which were reported to be
easily confused—and symbols that may
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generate critical confusion (London,
2003).
These reports serve to reinforce
OSHA’s longstanding belief that labels,
SDSs, and training are complementary
parts of a comprehensive hazard
communication program—each element
reinforces the knowledge necessary for
effective protection of employees. The
need for training to ensure
comprehension of hazard information is
widely recognized. Annex A of ANSI
Z535.2 (the American National Standard
for Environmental and Facility Safety
Signs), for example, recommends
training on the meaning of standard
safety symbols and signal words, and
ANSI Z535.4 contains similar guidance.
It is a longstanding Agency position
that employees have the ‘‘right to know’’
and understand the hazards of
chemicals they are exposed to in the
workplace (FR 53:29826; FR 59:6126).
This knowledge is needed in order to
take the precautions necessary for safe
handling and use, to recognize adverse
health effects associated with chemical
exposure, and to respond appropriately
in emergency situations.
Equally important in terms of
employee protection is that employers
have access to chemical hazard
information as well. Chemical
information is the foundation of
workplace chemical safety programs—
without it, sound management of
chemicals cannot occur. By ensuring
that emergency responders, physicians,
nurses, industrial hygienists, safety
engineers and other professionals have
the information they need to devise
protections, the HCS serves to reduce
the likelihood of chemical source
illnesses and injuries. Selection of
appropriate engineering controls, work
practices, and personal protective
equipment is predicated knowing the
chemicals that are present, the form
they are present in, and their hazardous
properties.
OSHA believes that the proposed
requirements would improve the quality
and consistency of the chemical hazard
information provided to employers and
employees. A combination of label
elements—signal word, hazard
statement(s), pictogram(s), and
precautionary statement(s)—is expected
to make label warnings more noticeable,
easier to understand, and better
communicate hazard and precautionary
information. Standardized headings and
a consistent order of information are
anticipated to make it easier for users to
find information on SDSs, improve their
accuracy, and better enable users to
compare the relative hazards of different
substances. Along with effective
training in the context of a
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comprehensive chemical hazard
communication program, these
revisions would serve to more
adequately inform employees of
chemical hazards, and lead to better
protections in the workplace.
OSHA’s preliminary determination to
modify the HCS is based on its
assessment of the potential to improve
employee safety and health. While
enhancing protection of employees is
the Agency’s objective in this
rulemaking, implementation of the GHS
is also anticipated to provide other
benefits. As indicated in Section IV,
modification of the HCS is expected to
promote a range of objectives.
Many countries do not currently have
regulatory requirements addressing
chemical hazard communication. Those
countries that do not have the resources
to develop a regulatory system can use
the GHS as a basis for establishing such
requirements. Implementation in these
countries will thus lead to
dissemination of information about
chemical hazards and protective
measures to individuals who would not
otherwise be afforded this benefit.
Transmittal of information provides a
basis for the sound management of
chemicals, which is beneficial not only
to the country where it is practiced, but
to neighboring countries as well. For
example, uncontrolled releases of
hazardous chemicals are not confined
by national borders. A coordinated and
harmonized approach to developing and
providing chemical hazard information
is beneficial to all.
The United Nations Institute for
Training and Research (UNITAR) and
the International Labor Organization
(ILO) have initiated a program to
support GHS implementation. The
program provides assistance regarding
development of national GHS
implementation strategies, legislation,
and other topics. UNITAR is supporting
national GHS implementation and
capacity building projects in Cambodia,
Indonesia, Laos, Nigeria, Senegal,
Slovenia, Thailand, the Gambia, and the
Philippines, and has supported
meetings, workshops, and regional
activities as well. Over 80 countries
have requested assistance from
UNITAR/ILO, indicating widespread
interest in GHS adoption throughout the
world.
Adoption of the GHS is also expected
to reduce the amount of testing
performed to identify hazardous
properties of chemicals. The HCS does
not currently require testing of
chemicals, and will not require testing
with adoption of the GHS. However,
testing is often performed to determine
how a chemical will be classified under
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the various systems currently in place.
By harmonizing definitions of hazards,
such testing would be minimized,
saving unnecessary use of test animals
and associated costs.
Implementation of the GHS is
expected to lessen the regulatory burden
associated with classification of
chemical hazards and labeling of
hazardous chemicals. In the U.S.,
regulatory authorities with jurisdiction
over the workplace, environment,
consumer and transport sectors (i.e.,
OSHA, EPA, CPSC, and DOT) are not
currently harmonized with regard to
definitions of hazards and other
requirements related to classification
and labeling of chemicals. Widespread
adoption of the GHS among the agencies
would simplify the process of
classifying chemicals and developing
labels. For example, most chemicals are
produced in a workplace and shipped
elsewhere. As a result, manufacturers
must comply with at least two sets of
requirements that are currently not
harmonized. Adoption of the GHS
would simplify this process. Thus every
chemical manufacturer would be likely
to experience some benefits from
harmonization, even if they are not
involved in international trade.
For those who are involved in
international trade in hazardous
chemicals, the expected benefits would
be even greater. As discussed in Section
III, different countries have established
requirements for chemical hazard
classification, labeling, and SDSs that
vary with regard to the scope of
chemicals covered, definitions of
hazards, the specificity of requirements,
and the use of symbols and pictograms.
Tracking the requirements of different
regulatory authorities and developing
different labels and SDSs is a burden for
all manufacturers, importers,
distributors, and transporters. Chemical
manufacturers that do not have the
resources to identify and comply with
the requirements of regulatory
authorities in different countries are
precluded from engaging in trade with
those countries. Small businesses are
particularly affected. Implementation of
the GHS would alleviate this burden
and simplify the provision of chemical
hazard information in international
commerce.
VI. Pertinent Legal Authority
The primary purpose of the
Occupational Safety and Health Act (the
‘‘OSH Act’’ or ‘‘Act’’) (29 U.S.C. 651 et
seq.) is to assure, so far as possible, safe
and healthful working conditions for
every American employee over the
period of his or her working lifetime.
One means prescribed by the Congress
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to achieve this goal is the mandate given
to, and the authority vested in, the
Secretary of Labor to ‘‘promulgate,
modify, or revoke’’ mandatory
occupational safety and health
standards. OSH Act § 6(b), 29 U.S.C.
655(b).
An occupational safety and health
standard is defined under the Act as:
[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 a safe or healthful employment and
places of employment.
srobinson on DSKHWCL6B1PROD with PROPOSALS2
OSH Act § 3(8), 29 U.S.C. 652(8). The
Supreme Court has interpreted this
provision as requiring OSHA to
determine, before promulgating a
permanent standard under section 6(b)
of the Act, that the standard is
reasonably necessary and appropriate to
remedy a significant risk of material
health impairment. Industrial Union
Dep’t v. American Petroleum Institute,
448 U.S. 607, 642 (1980) (‘‘Benzene’’).
This ‘‘significant risk’’ determination
constitutes a finding that, absent the
change in practices mandated by the
standard, the workplaces in question
would be ‘‘unsafe’’ in the sense that
employees would be threatened with a
significant risk of harm. Id.
OSHA’s Hazard Communication
Standard (‘‘HCS’’) is a health standard
promulgated under the authority of
sections 6(b)(5) and 6(b)(7) of the Act.
Associated Builders & Contractors, Inc.
v. Brock, 862 F.2d 63, 67–68 (3d Cir.
1988); United Steelworkers of America
v. Auchter, 763 F.2d 728, 738 (3d Cir.
1985); United Steelworkers of America
v. Auchter, 819 F.2d 1263, 1267 (3d Cir.
1987). Authority for the HCS may also
be found in section 8(c) and 8(g) of the
Act. Section 8(c)(1) of the Act empowers
the Secretary to require employers to
make, keep, and preserve records
regarding activities related to the Act
and to make such records available to
the Secretary. 29 U.S.C. 657(c)(1).
Section 8(g)(2) of the Act empowers the
Secretary to ‘‘prescribe such rules and
regulations as (she) may deem necessary
to carry out (her) responsibilities under
this Act * * *’’ 29 U.S.C. 657(g)(2).
Section 6(b)(5) provides that:
The Secretary, in promulgating standards
dealing with toxic materials, or harmful
physical agents under this subsection, shall
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. Development of standards
under this subsection shall be based upon
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research, demonstrations, experiments, and
such other information as may be
appropriate. In addition to the attainment of
the highest degree of health and safety
protection for the employee, other
considerations shall be the latest available
scientific data in the field, the feasibility of
standards, and experience gained under this
and other health and safety laws. Whenever
practicable, the standard promulgated shall
be expressed in terms of objective criteria
and of the performance desired.
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 a
proposed standard, section 6(b)(5)
requires it 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.’’ American Textile
Manufacturers Institute, Inc. v.
Donovan, 452 U.S. 490, 509 (1981)
(‘‘Cotton Dust’’). Where, however,
OSHA is confronted with two feasible
methods of reducing risk to the
appropriate level, OSHA must chose the
cheaper method. Id. at 513 n.32;
International Union, UAW v. OSHA, 37
F.3d 665, 668 (D.C. Cir. 1994).
In addition, section 6(b)(7) of the Act
provides in part that:
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
medical 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
Supreme Court has recognized such
protective measures may be imposed in
workplaces where chemical exposure
levels are below that for which OSHA
has found a significant risk. Benzene,
448 U.S. at 657–58 & n.66. In Benzene,
the Court relied on § 6(b)(7) to uphold
the imposition of exposure and medical
monitoring requirements at exposures to
benzene below the permissible exposure
limit. Id. These requirements serve as a
‘‘backstop,’’ the Court said, allowing
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OSHA to check the validity of its
assumptions in developing the PEL and
employers to remove workers before
they suffered any permanent damage.
Id. at 657–58.
In making the determinations
required by the Act, OSHA’s
conclusions must be ‘‘supported by
substantial evidence in the record
considered as a whole.’’ OSH Act § 6(f),
29 U.S.C. 655(f). OSHA must use the
‘‘best available evidence,’’ which
includes ‘‘the latest 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.’’ OSH Act
§ 6(b)(5), 29 U.S.C. 655(b)(5). The
Supreme Court has held that OSHA is
not required to support its finding of
significant risk ‘‘with anything
approaching scientific certainty,’’ and
that the determination of whether a
particular risk is ‘‘ ‘significant’ will be
based largely on policy considerations.’’
Benzene, 448 U.S. at 655–56 & n.62.
The OSH Act allows the Secretary to
‘‘modify’’ and ‘‘revoke’’ existing
occupational safety or health standards.
OSH Act § 6(b), 29 U.S.C. 655(b). In
passing the 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 v. State Farm Mut.
Automobile Ins. Co., 463 U.S. 29, 42
(1983) (internal quotation marks and
citations omitted).
A. Significant Risk. Most OSHA
health standards protect employees by
imposing requirements when employees
are exposed to a concentration of a
hazardous substance that OSHA has
found to create a significant risk of
material health impairment. Thus, in
making the significant risk
determination in these cases, OSHA is
concerned with measuring the exposure
an employee may be expected to incur
when dealing with these substances to
determine the level at which a
significant risk arises.
OSHA took a different approach to its
significant risk determinations in
promulgating the HCS in 1983 and
revising it in 1994. Rather than
attempting to assess the exposure—and
therefore the risk—associated with the
use of each hazardous chemical in each
industry to determine if that chemical
posed a significant risk in that industry,
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OSHA took a more general approach. It
relied on NIOSH data showing that
about 25 million or about 25% of
American employees were potentially
exposed to one or more of 8,000 NIOSHidentified 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. It then noted the consensus
evident in the record among labor,
industry, health professionals, and
government that an ‘‘effective federal
standard requiring employers to identify
workplace hazards, communicate
hazard information to employees, and
train employees in recognizing and
avoiding those hazards’’ was necessary
to protect employee health. 48 FR
53283.
Thus, OSHA found that because
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inadequate communication about serious
chemical hazards endangers workers and that
the practices required by this standard are
necessary or appropriate to the elimination or
mitigation of these hazards, the Secretary is
hereby able to make the threshold
‘‘significant risk’’ determination that is an
essential attribute of all permanent standards.
48 FR 53321. The U.S. Court of Appeals
for the Third Circuit has on several
occasions upheld this determination of
significant risk as sufficient to justify
the HCS under OSH Act § 6(b). See
Associated Builders & Contractors, 862
F.2d at 67 (discussing the history of its
review of the issue).
A characteristic of hazard
communication that OSHA confronted
in adopting the HCS is that information
about the hazards associated with a
particular chemical, and the exposures
associated with its use, are not
uniformly distributed across industry.
That is, chemical manufacturers and
importers tend to have greater
knowledge and scientific expertise with
respect to the composition of the
chemicals they make or import. See 48
FR 53306, 53322. Therefore, they are
usually in the best position to assess the
inherent hazards associated with them.
Id. However, it is the downstream users
and their employees who tend to have
the best information about the means
and methods of exposure, and are
therefore usually in the best position to
determine the risk arising from the use
of the chemical in their workplaces. See
48 FR 53295–96, 53307; 59 FR 6132.
OSHA’s approach in promulgating the
HCS reflects this reality. It places the
duty to ascertain and disclose chemical
hazards on manufacturers and
importers, so that downstream users can
use this information to avoid harmful
exposures to chemical hazards. But
because manufacturers and importers
will often have less information about
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the particular exposures of downstream
users, their hazard assessment and
communication obligations are imposed
only for all normal conditions of use of
their chemicals and foreseeable
emergencies associated with those
chemicals. 29 CFR 1910.1200(b)(2).
In previous rulemakings, OSHA
rejected suggestions that these
obligations 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 where these risks
might occur before the fact. 49 FR
53295–96; 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. Id. 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. Durez Div. of
Occidental Chemical Corp v. OSHA, 906
F.2d 1, 4 (D.C. Cir. 1990); General
Carbon Co. v. OSHRC, 860 F.2d 479,
485 (D.C. Cir. 1988).
For these reasons, hazard
communication—as opposed to risk
communication—‘‘most adequately
assures’’ employee protection from the
significant risk of material impairment
of health arising from the use of
hazardous chemicals in the workplace
for purposes of OSHA’s authority under
section 6(b)(5) of the Act. In addition,
HCS is authorized under section 6(b)(7),
which requires OSHA to prescribe
‘‘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.’’ As
noted above, the Benzene case
recognizes 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. In this
way, the HCS assures that employers
and employees have the information
they need to avoid situations of
exposure in the work place even before
the employee is exposed to a hazardous
chemical.
The current proposal makes no
conceptual or theoretical change in this
approach. It still imposes the same
general requirements: Hazard
identification, labeling, safety data
sheets, a written hazard communication
program, and employee training.
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OSHA’s determination that inadequate
communication about hazardous
chemicals constitutes a significant risk
supports the incorporation of the GHS
into the HCS, just as it supported the
promulgation of the original HCS and its
subsequent modifications. Further, the
data discussed in parts V and VII of this
preamble show that the significant risk
continues to exist even under the
current standard. OSHA estimates that
over 40 million employees are
potentially exposed to hazardous
chemicals. BLS data show that in 2007,
there were approximately 54,000
illnesses related to hazardous chemical
exposure and 125 chemically-related
fatalities. These new statistics probably
represent only a small portion of the
illnesses experienced by exposed
employees because many illnesses are
not reported as being related to
workplace exposures, due to long
latency periods, and other factors. For
all the reasons detailed in Section V, the
agency believes that adoption of the
GHS will improve communication of
the hazards associated with the use of
chemicals, and reduce significant risk.
B. Section 6(b)(7) Authority. With
respect to labels and employee
warnings, 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 4, United States Code, 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 has used the authority of
section 6(b)(7) in the past to revise its
standards. See, e.g., Standards
Improvement Project—Phase II, 70 FR
1112 (January 5, 2005); Standards
Improvement (Miscellaneous Changes)
for General Industry and Construction
Standards, 63 FR 33450, 33458 (June 18,
1998). For example, it used this
authority to revise the inorganic arsenic
and coke oven emissions standards to
eliminate the requirement of sputum
cytology testing and to reduce the
required frequency of mandatory chest
x-rays from semi-annual to annual. 63
FR 33458. OSHA justified these changes
on the grounds that studies reported
after the promulgation of the relevant
standards showed that sputum-cytology
did not improve employee survival rates
and the survival rates for semi-annual xrays were not higher than annual exams.
63 FR 33458–59. In addition, OSHA has
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used its section 6(b)(7) authority to
authorize new respirator fit protocols
under its respiratory protection
standard. 69 FR 46986 (August 4, 2004);
see generally 29 CFR 1910.134 App. A,
Pt. II.
OSHA’s proposal to revise the HCS
fits well within the authority granted by
the last sentence of § 6(b)(7). Adoption
of GHS provisions would constitute a
‘‘modification[]’’ of the HCS regarding
‘‘the use of labels or other forms of
employee warning.’’ For the reasons
summarized above and explained more
fully elsewhere in this preamble, OSHA
believes that the adoption of GHS to be
‘‘appropriate’’ based on ‘‘experience,
information, or medical or technological
developments acquired subsequent to
the promulgation of the relevant
standard.’’ The formulation of GHS may
also be considered a ‘‘technological
development’’ that has occurred since
the promulgation of the original
standard in 1983. 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 Part III above
and 71 FR 53618–19. Indeed, OSHA
noted the possibility of a future
internationally harmonized standard in
the preamble accompanying the original
rule. 48 FR 53287.
The last sentence of section 6(b)(7)
also requires consultation with the
Secretary of Health and Human
Services. OSHA briefed NIOSH on this
proposal as a part of the October 2008
OSHA–NIOSH Issues Exchange
meeting, which was attended by
NIOSH’s Acting Director, and NIOSH
expressed its support. OSHA has also
briefed NIOSH on the GHS in previous
Issues Exchange meetings. In addition,
NIOSH has actively supported the GHS
during its development and has been
involved in the development of control
banding, international chemical safety
cards, and employee training for the
GHS. NIOSH has submitted a comment
supporting OSHA’s proposal, (Ex. 2–46–
1), and reviewed a draft of both this
NPRM and the ANPR before it was
published. NIOSH has stated that it
supports OSHA in its proposal to update the
HCS and to address the changes in hazard
criteria, to include all 16 physical hazard
criteria, and to adopt the specific labeling
requirements and the safety data sheet (SDS)
order of information in the Globally
Harmonized System of Classification and
Labelling of Chemicals.
(Document ID # 0082) These
consultations coupled with OSHA’s ongoing relationship with NIOSH are more
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than sufficient to satisfy the
requirement. For all the reasons set forth
above, revision of the HCS through
adoption of the GHS as proposed by
OSHA is authorized by section 6(b)(7) of
the OSH Act, 29 U.S.C. 655(b)(7).
C. Section 6(b)(5) Authority. OSHA
also has authority to adopt the proposal
under section 6(b)(5) of the Act, 29
U.S.C. § 655(b)(5). As noted above,
section 6(b) explicitly allows OSHA to
‘‘modify’’ standards, and adoption of the
GHS is justified because it ‘‘most
adequately assures’’ employee
protection for purposes of section
6(b)(5) for the reasons detailed in part V
of this preamble. Section 6(b)(5) also
requires a finding that the proposed
standard is feasible, which means
‘‘capable of being done, executed or
effected.’’ Cotton Dust, 452 U.S. at 508–
09.
Feasibility has two aspects, economic
and technological. United Steelworkers
of America v. Marshall, 647 F.2d 1189,
1264 (D.C. Cir. 1981) (‘‘Lead I’’). 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. A standard
is economically feasible if industry can
absorb or pass on the cost of compliance
without threatening its longer term
profitability or competitive structure.
See Cotton Dust, 452 U.S. at 530 n.55;
Lead I, 647 F.2d at 1265.
In addressing feasibility in the 1994
HCS revisions, OSHA found that:
The feasibility question raised by the HCS
is not difficult to resolve. This standard does
not relate to activities on the frontiers of
scientific knowledge; the requirements are
not the sorts of obligations that approach the
limits of feasibility. Associated Builders &
Contractors, 862 F.2d at 68. The record on
which the original and expanded HCS’s were
based did not contain credible evidence that
the HCS would be technologically or
economically infeasible for any industrial
sector, id., and there was substantial
evidence of feasibility, 52 FR 31855–58.
59 FR 6133. OSHA has repeatedly found
that the requirements of the HCS are
technologically feasible. See 52 FR
31855–57; 59 FR 6133. While the GHS
modifications to HCS impose more
specific requirements for hazard
classification, labeling, and safety data
sheets, employers may use the same
methods to meet these requirements as
they are already utilizing to comply
with the requirements of HCS.
The most important resource
employers will need to comply with the
GHS modifications to HCS is technical
expertise in hazard classification and
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the communication of those hazards.
OSHA found that such expertise was
already available in promulgating the
initial HCS rule in 1983. 48 FR 53296–
99. OSHA believes that the availability
of professionals with this expertise has
only increased in the intervening time.
At least one professional organization
provides training in hazard
communication to professionals and
businesses. (Document ID #s 0021 and
0145.) Through OSHA’s Alliance with
the Society for Chemical Hazard
Communication, training to small
businesses in the requirements of
hazard communication and information
about the GHS modifications has been
made available. See https://
www.osha.gov/dcsp/alliances/schc/
schc.html. NIOSH is preparing a
program for employers to use in training
their employees in the new labeling
scheme. (Document ID # 0082.) OSHA
received numerous comments in
response to its September 12, 2006
ANPR discussing the professionals and
tools (both manual and electronic) that
employers have available to comply
with current hazard communication
requirements. (See, e.g., Document ID #s
0042, 0046, 0050, 0053, 0072, 0077,
0015, 0024, 0026, 0036, 0038, 0107,
0108, 0116, 0123, 0128, 0141, 0144,
0145, 0154, 0155, and 0163.) The
Agency has been engaged on several
fronts to facilitate the transition from
the current standard to the GHS
modifications, if ultimately adopted. For
instance, the United Nations Institute
for Training and Research (UNITAR) is
developing basic and more advanced
training courses for the GHS, and OSHA
has been involved with and committed
resources to this effort. NIOSH’s
comment also discussed the
development of the WHO/IPCS
International Chemical Safety Cards,
which includes the GHS pictograms and
signal words. (Document ID # 0082.)
OSHA believes that adopting the GHS
modifications as proposed poses no
technological feasibility issues.
Likewise, for the reasons more fully
discussed in the Preliminary Regulatory
Analysis, OSHA believes that there is
nothing about the adoption of GHS that
will pose economic feasibility issues.
Again, OSHA has found that the
implementation of HCS in the first
instance would have no such effect. See
52 FR 31855–57; 59 FR 6133. Most
commenters agreed that, once
conversion to the new system is
completed, compliance with the GHSmodified HCS will not be more
expensive than compliance with the
current HCS. (Document ID #s 0046,
0047, 0080, 0103, 0104, 0105, 0179,
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0119, 0123, 0129, 0135, 0139, 0145,
0147, and 0163.) While industry will
incur the cost of converting to the new
system, OSHA does not believe that this
cost is so substantial as to threaten long
term profitability or the competitive
structure of any industry.
Finally, OSHA is not proposing to
‘‘delegate[e] power to an international
body’’ through the adoption of the GHS
or justifying this proposal as a means to
reduce ‘‘potential barriers to
international trade,’’ as suggested in the
comments. (Document ID #s 0065 and
0026). OSHA recognizes, however, that
there are potential benefits to
international trade by adopting the GHS,
and these are discussed in section VII of
this preamble, OSHA is proposing to
comply with the OSH Act’s mandate to
assure as far as possible safe and
healthful working conditions in this
country by incorporating the GHS’s
improved hazard communications
requirements into the HCS through the
process authorized by section 6 of the
OSH Act. Adoption of the GHS
modifications into the HCS would not
place any new obligations on OSHA to
comply with the requirements of any
foreign or international body.
VII. Preliminary Economic Analysis
and Initial Regulatory Flexibility
Screening Analysis
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A. Introduction and Summary
Introduction
OSHA is required by the
Occupational Safety and Health (OSH)
Act of 1970 to ensure and demonstrate
that standards promulgated under the
Act are reasonably necessary and
appropriate, as well as technologically
and economically feasible. Executive
Order 12866, the Regulatory Flexibility
Act, and the Unfunded Mandates
Reform Act also require OSHA to
estimate the costs, assess the benefits,
and analyze the impacts of certain rules
that the Agency promulgates.
Accordingly, OSHA has prepared this
Preliminary Economic Analysis (PEA),
including an Initial Regulatory
Flexibility Screening Analysis (IRFSA),
for the proposed modifications to the
Hazard Communication Standard (HCS).
The OSHA PEA is based largely on
research conducted for this purpose by
Policy, Planning, and Evaluation, Inc.
(PP&E), as presented in their report,
‘‘Data and Analysis in Support of an
Economic Analysis of Proposed Changes
to the OSHA Hazard Communication
Standard,’’ prepared under contract to
OSHA. The PP&E report is available in
the public docket for this rulemaking,
OSHA–H022K–2006–0062, through
www.regulations.gov.
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Need for Regulation
Employees in work environments
covered by the HCS are exposed to a
variety of significant hazards that can
and do cause serious injury and death.
The HCS serves to assure that both
employers and employees are provided
needed information about chemical
hazards that was not provided by
markets in the absence of such a
standard. The HCS also facilitates
interstate commerce by promoting
consistency among Federal and
individual State requirements.
The proposed changes would create a
uniformity standard for the presentation
of risk information and, as such, would
serve to improve the efficiency and
effectiveness of the existing hazard
communication system in the U.S., and
to reduce unnecessary barriers to trade.
Hazard communication is currently
addressed by many different
international, national, and State
authorities. As described in Section V of
the preamble, these existing
requirements are not always consistent
and often contain different definitions
of hazards and varying provisions for
what information is required on labels
and safety data sheets. Complying with
these different rules results in increased
costs for employers with hazardous
chemicals in their workplace and for
chemical manufacturers, distributors,
and transporters involved in
international trade. In addition to these
effects on businesses, the different
existing requirements result in
workplaces receiving chemicals with
varying information, with potential
adverse impacts on the safety and health
of employees. The proposed revisions to
the OSHA HCS would standardize the
hazard communication requirements for
products used in U.S. workplaces, and
thus provide employees with uniform
and consistent hazard communication
information. Secondarily, because these
proposed revisions would harmonize
the U.S. system with international
norms, they would facilitate
international trade.
Affected Industries
The proposal would affect employers
and employees in many different
industries across the economy. Based on
the PP&E report, OSHA estimates in
Table VII–2 that the HCS covers over
five million workplaces in which
employees are potentially exposed to
hazardous chemicals.
For establishments with employees
whose exposures to hazardous
chemicals results from their use of the
chemical products, the proposed
revisions to the HCS would generally
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50307
involve minor effects, such as
familiarization with new warning labels.
For establishments producing hazardous
chemicals, which are generally part of
the chemical manufacturing industry,
the revisions to the standard would
involve reclassifying chemicals in
accordance with the new classification
system and revising safety data sheets
(SDSs) and labels associated with
hazardous chemicals. OSHA has
preliminarily judged that SDSs for
imported chemicals would normally be
produced in the country of origin, and
thus would not represent expenses for
importers. OSHA welcomes comment
on this judgment.
Benefits, Net Benefits, and CostEffectiveness
There is ample evidence of the
substantial risks of chemical exposure
in the workplace. In 2007, according to
the Bureau of Labor Statistics,
employees suffered an estimated 55,400
illnesses attributable to chemical
exposures (BLS, 2008), and some 17,340
chemical-source injuries and illnesses
involved days away from work (BLS,
2009). However, as noted in the
preamble to the HCS in 1983, BLS
estimates probably only reflect a small
percentage of occupational illnesses (48
FR 53284) because most occupational
illnesses are not reported. The principal
reasons are that they are not recognized
as being related to workplace exposures
and are subject to long latency periods
between exposure and the manifestation
of disease. The key study of the issue of
the number of fatalities from chronic
illnesses, not recorded in any way by
BLS, is Leigh et al., 1997. That study
found that in 1992, there were from
46,900 to 73,700 fatalities from chronic
illnesses related to occupational
exposures to chemicals. This critical
category dwarfs all acute injuries and
illnesses due to chemicals recorded by
BLS.1
Section V of the preamble describes
some of the incidents that may have
been related to the non-standardized
approach to SDSs in the current HCS,
1 A more recent study prepared by the University
of California Centers for Occupational and
Environmental Health, and commissioned by the
California Environmental Protection Agency,
suggests that fatalities from chronic illnesses remain
an important problem (University of California
COEH, 2008, p. 18). That study estimated that, in
2004, more than 200,000 workers, in California
alone, were diagnosed with serious chronic diseases
(encompassing cancer, COPD, asthma,
pneumoconiosis, chronic renal failure, and
Parkinson’s disease) attributable to chemical
exposures in the workplace, and that an additional
4,400 workers in California died during that year
from chemical exposures in the workplace.
Underlying studies are to appear in forthcoming
publications.
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including xylene exposure at a hospital
when an employee was unable to find
critical information on an SDS in an
emergency spill situation (Hanson,
2004). As a result, twelve employees
required emergency room treatment.
Another example is the explosion at a
manufacturing plant in Corbin, KY,
which resulted in the death of 7 workers
and injuries to another 37 workers. A
Federal investigation into the explosion
concluded that the cause was the
inability to effectively identify and
respond to the inherent explosive
hazards of phenolic resin and
specifically referenced the MSDS for
phenolic resin dust (U.S. Chemical
Safety and Hazard Investigation Board,
February 2005). Were the information
on SDSs more uniformly formatted and
comprehensible, as required under the
proposed modifications to HCS,
incidents such as those described above
would be less likely to occur.
In general, the proposed
modifications to the HCS are expected
to result in increased safety and health
for the affected employees and to reduce
the numbers of accidents, fatalities,
injuries, and illnesses associated with
exposures to hazardous chemicals.
It is difficult to quantify precisely
how many injuries, illnesses, and
fatalities would be prevented due to the
proposed revisions to the HCS. The
benefits associated with the existing
HCS may indirectly help provide a
general sense of the potential magnitude
of the benefits of the proposed revisions
to the HCS. OSHA preliminarily
estimates that if the proposed rule could
capture one percent of the benefits
estimated for the original 1983 and 1987
HCS rules, the proposed revisions
would result in the prevention of 318
non-lost-workday injuries and illnesses,
203 lost-workday injuries and illnesses,
64 chronic illnesses, and 43 fatalities
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annually. The monetized value of the
corresponding reduction in
occupational risks among the affected
employees is an estimated $266 million
on an annualized basis.
The harmonization of hazard
classifications, safety data sheet formats,
and warning labels for affected
chemicals and products would also
involve substantial savings to
businesses. Fewer different SDSs would
have to be produced for affected
chemicals, and many SDSs would be
able to be produced at lower cost due
to harmonization and standardization.
The benefits represented by these cost
reductions would primarily affect
businesses involved in chemical
manufacturing. In addition, businesses
that purchase or use hazardous
chemicals can expect reductions in
operating costs as a result of the
promulgation and implementation of
the proposed modifications.
PP&E conducted extensive research
on the processes that companies use to
classify chemical hazards, to develop
SDSs and labels, and to handle, store,
and use hazardous chemicals. PP&E
evaluated how these processes would be
affected by the proposed revisions to the
HCS and analyzed the potential savings
that would be realized as a result of
adopting these revisions. Based on
PP&E’s research, OSHA has concluded
that the annual cost savings for these
companies would be an estimated $585
million.
As an additional benefit, the
modification of the HCS by the
inclusion of the globally harmonized
system (GHS) of classification and
labelling of chemicals would be
expected to facilitate international trade,
increasing competition, increasing
export opportunities for U.S. businesses,
reducing costs for imported products,
and generally expanding the selection of
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chemicals and products available to
U.S. businesses and consumers. As a
result of both the direct savings
resulting from harmonization and the
increased competitiveness, prices for
the affected chemicals and products,
and the corresponding goods and
services using them, would be lowered.
The proposed revisions may also
result in reductions in the costs
associated with providing training for
employees as required by the existing
OSHA HCS.
Finally, the proposed GHS
modifications to the OSHA HCS would
meet the international goals for
adoption and implementation of the
GHS that were supported by the U.S.
government. Implementing GHS in U.S.
Federal laws and policies through
appropriate legislative and regulatory
action was anticipated by the U.S.
support of 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 (see https://
www.chem.unep.ch/saicm/).
Table VII–1 provides a summary of
the costs and benefits of the proposed
modifications to the OSHA HCS, and it
shows the net benefits of the
modifications to the standard, which are
estimated to be $754 million annually.
Because compliance with the proposed
standard would result in cost savings
that exceed costs, OSHA has not
provided estimates of costs per life
saved or other metrics of costeffectiveness. However, it should be
noted that the estimated benefits exceed
costs by a factor of eight.
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Compliance Costs
The estimated compliance costs for
the proposed revisions to the HCS
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represent the additional costs necessary
for employers to achieve full
compliance. They do not include costs
associated with current compliance that
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has already been achieved with regard
to the new requirements; nor do they
include costs necessary to achieve
compliance with existing requirements,
to the extent that some employers may
currently not be fully complying with
applicable regulatory requirements.
The costs associated with compliance
with the proposed revisions to the HCS
would generally be incurred by the
affected industries as one-time
transition costs over the phase-in period
of three years. Aside from the transition
costs, the ongoing annual compliance
costs associated with the proposed
revisions to the HCS generally are
expected to be the same or lower than
under the existing standard.
The compliance costs are expressed as
an annualized cost for purposes of
assessing the cost-effectiveness of the
proposed revisions, in order to be able
to compare the economic impact of the
rulemaking with other regulatory
actions, and to be able to add and track
Federal regulatory compliance costs and
economic impacts in a consistent
manner. Annualized costs also represent
a better measure for assessing the
longer-term potential impacts of the
rulemaking. The annualized cost was
calculated by annualizing the one-time
costs over a period of 20 years and
applying a discount rate of 7 percent, as
recommended by the Office of
Management and Budget.
The total annualized cost of
compliance with the proposed standard
is estimated to be about $97 million.
The major cost elements associated with
the revisions to the standard include the
classification of chemical hazards in
accordance with the GHS criteria and
the corresponding revision of safety data
sheets and labels to meet new format
and content requirements ($11 million);
training for employees to become
familiar with new warning symbols and
the revised safety data sheet format ($44
million); and management
familiarization and other managementrelated costs as may be necessary ($42
million).
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Economic Impacts
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
new requirements on entities in each of
the affected industry sectors. The
estimated compliance costs were
compared with industry revenues and
profits to provide an assessment of the
economic feasibility of complying with
the revised standard and an evaluation
of the potential economic impacts.
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Only the compliance costs were
considered for purposes of assessing the
potential economic impacts and
economic feasibility of the proposed
revisions. As described in section D of
this PEA, the overall economic impacts
associated with this rulemaking are
expected to result in significant net
benefits to employers, employees, and
the economy generally.
As described in greater detail in
section G of this PEA, the costs of
compliance with the proposed
rulemaking are not large in relation to
the corresponding annual financial
flows associated with each of the
affected industry sectors. The estimated
costs of compliance represent about
0.0004 percent of revenues and about
0.007 percent of profits, on average,
across all entities; compliance costs do
not represent more than 0.02 percent of
revenues or more than 0.3 percent of
profits in any individual affected
industry sector.
The economic impact of achieving
compliance with the proposal, without
considering the associated benefits, is
most likely to consist of an extremely
small increase in prices of about 0.0004
percent, on average, for affected
hazardous chemicals. It is highly
unlikely that a price increase of this
magnitude would significantly alter the
types or amounts of goods and services
demanded by the public or any other
affected customers or intermediaries. If
the compliance costs of the proposal can
be substantially recouped with a
minimal increase in prices, there may be
little or no effect on profits.
In general, for most establishments, it
would be very unlikely that none of the
compliance costs could be passed along
in the form of increased prices. In the
event that a price increase of 0.0004
percent were not possible, profits in the
affected industries would be reduced by
an average of about 0.007 percent.
Given the minimal potential impact
on prices or profits in the affected
industries, OSHA has preliminarily
concluded that compliance with the
requirements of the proposed
rulemaking would be economically
feasible in every affected industry
sector.
In addition, based on an analysis of
the costs and economic impacts
associated with this rulemaking, OSHA
preliminarily concludes that the effect
of the proposed standard on
employment, wages, and economic
growth for the United States would be
negligible. The effect on international
trade is likely to be beneficial and
similar to the effect of a small reduction
in non-tariff trade barriers.
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Initial Regulatory Flexibility Screening
Analysis
OSHA has analyzed the potential
impact of the proposed rule on small
entities, and has prepared an Initial
Regulatory Flexibility Screening
Analysis (IRFSA) in conjunction with
this rulemaking to describe the potential
effects on small entities. The IRFSA is
included as a part of this PEA in section
H.
As a result of the analysis of the
potential impact on small entities,
OSHA concludes and certifies that the
rulemaking would not have a significant
impact on a substantial number of small
entities. Therefore, an Initial Regulatory
Flexibility Analysis (IRFA) is not
required for this rulemaking.
Nevertheless, OSHA has voluntarily
provided the elements of the IRFA as
part of the IRFSA presented in Section
H. In proceeding with this rulemaking,
OSHA will fulfill its requirements under
the Regulatory Flexibility Act and under
the Small Business Regulatory
Enforcement Fairness Act, as applicable,
to ensure that no unnecessary burdens
are imposed on small businesses.
The remainder of this PEA includes
the following sections:
B. Need for Regulation;
C. Profile of Affected Industries;
D. Benefits, Net Benefits, and CostEffectiveness;
E. Technological Feasibility;
F. Costs of Compliance;
G. Economic Feasibility and Impacts;
H. Initial Regulatory Flexibility Screening
Analysis;
I. Environmental Impacts;
J. Unfunded Mandates Reform Act
Analysis;
K. Sensitivity Analysis.
B. Market Failure and the Need for
Regulation
Employees in work environments
addressed by the HCS are exposed to a
variety of significant hazards associated
with chemicals used in the workplace
that can and do cause serious injury and
death. OSHA’s HCS was designed to
assure that employers and employees
are provided the information they need
about the chemical hazards in chemical
products both to make informed
purchases and to provide for safe use. In
the existing HCS, OSHA developed a set
of requirements for chemical products,
to include mandatory classification,
labeling, and detailed information
provision (in safety data sheets). OSHA
believes that the improvements in the
proposed rule would make the hazard
communication system more workerprotective and more efficient and
effective. In addition, the improvements
would have the effect of harmonizing
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hazard communication to facilitate
international trade—replacing a
plethora of national rules with a single
international system.
The proposed standard, through
conformance with GHS (as explained in
Section IV of the preamble), contains a
number of changes to improve the
performance of the U.S. hazard
communication system:
• Revised criteria for more consistent
classification of chemical hazards;
• Standardized signal words,
pictograms, hazard statements, and
precautionary statements on labels; and
• A standardized format for SDSs.
In short, GHS is a ‘‘uniformity
standard’’ for the presentation of hazard
information (Hemenway, 1975, p. 8).
And much like other uniformity
standards, such as driving on the right
side of the road (in the U.S.), screw
threads for fire hose connectors,
‘‘handshake’’ protocols for
communication between computers,
and, for that matter, language, GHS
would provide significant efficiencies
and economies.2 In the case of GHS,
manufacturers would be able to produce
SDSs at lower cost, and users of SDSs
would be able to more fully and quickly
utilize the information contained in the
SDSs, thereby reducing costs and, more
importantly, better protect workers
against chemical hazards.3
Since publication of the existing HCS,
there has been some movement by
industry toward standardization,
consistent with the proposed revisions.
However, OSHA does not believe that
full and comprehensive standardization,
as required under the proposed
revisions, or that the goal of
2 In contrast to a uniformity standard, 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, only a
specification standard would guarantee that
employees are protected against the risk in
question. Note that an engineering standard would
generally not provide efficiencies or economies to
the regulated community. On the contrary, an
engineering standard would impose additional
costs on some firms, in that they could effectively
protect workers using an alternative approach, if it
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
GHS is limited to the presentation of hazard
information and does not involve technological or
strategic considerations, the possible costs of
uniformity here would be non-existent or
minuscule.
3 On the ability of individuals to more fully and
effectively utilize knowledge when uniformity
requirements are present, see Hemenway, 1975, pp.
34–35.
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harmonizing the U.S. system with the
international one could be achieved
voluntarily in the absence of regulation.
First, in a basic sense, GHS cannot
simply be implemented by the market.
Some aspects of GHS, such as the
reorganization of SDSs, would be
allowed under the existing OSHA
standard, but other aspects, such as the
classifications system, would not be.
Use of differing classification criteria
would lead to label warnings that are
not consistent with current HCS
requirements in some situations. Thus,
at a minimum, OSHA would need to
modify HCS to allow the use of GHS in
the U.S. OSHA cannot simply provide a
compliance interpretation that labels
and safety data sheets prepared in
accordance with the GHS meet the HCS
requirements because the requirements
of a standard cannot be changed through
a compliance interpretation. While there
is considerable overlap between the
HCS and the GHS in terms of coverage,
there are differences in the criteria used
to classify both substances and mixtures
that will result in different hazards
being covered in some situations. This
is particularly true in the area of acute
toxicity, where OSHA is covering more
substances under the modified rule than
the current HCS, but potentially fewer
mixtures.4
Second, it is important to understand
that while the costs of creating SDSs
and labels under GHS are borne directly
by the chemical producers, the bulk of
the benefits of adopting GHS accrue to
the users. The set of all users includes
employers who are direct customers of
a chemical manufacturer, employees
who use or are exposed to workplace
chemicals, and emergency responders,
who typically have no market
relationship with the producers of the
chemical. Even if one thought that
market forces might assure the socially
optimal approach to SDSs between
manufacturers of chemicals and their
customers, there are limited market
forces at work between the chemical
manufacturer and these two other sets of
users—the employees and the
emergency response community.
Therefore, the presence of positive GHS
externalities would prevent the private
market, without regulation, from
achieving the socially optimal adoption
of GHS.
OSHA does anticipate that there will
be some increased market pressure to
comply with GHS that will affect some
firms that may think that they have no
4 The coverage of fewer mixtures is due to the
bridging principles and formula being applied to
their classification, rather than being based strictly
on a 1 percent cut-off.
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need to switch to the GHS system
because they do not ship their products
internationally. Many small firms do not
realize the extent to which they are
involved in international trade. There
are probably few companies who have
products that are never involved in
international trade, or who never import
chemical products and need hazard
communication information for them.
Many chemical producers ship their
products to distributors and are
unaware of where their products are
ultimately used. OSHA can envision a
likely scenario in which these
distributors provide pressure to their
suppliers to become GHS-compliant.
Further, small companies sell products
to larger companies. The larger
companies may use those products to
prepare goods that are exported. These
larger companies might also be expected
to pressure their small firm suppliers to
be GHS-compliant. Nevertheless, such
an approach would surely involve a
long transition period, with attendant
losses in worker protection and
production efficiencies, and it is
doubtful that market pressure alone
would achieve full compliance.
The changes made by GHS will
involve costs for all parties. Producers
of chemicals will incur substantial costs
but will also achieve benefits—in part
because they themselves benefit as both
producers and users, and in part, as a
result of foreign trade benefits that
OSHA has not quantified. Some
producers will not see these types of
trade benefits if they do not engage in
exporting chemicals. However, many
small companies are currently
prevented from engaging in
international trade because of the
substantial burdens of complying with
many different countries’ requirements.
International harmonization of hazard
communication requirements would
enable these small companies to become
involved in international trade if they so
desire.
Of more significance to the concerns
of the OSH Act, the changes also
provide substantial benefits to users,
including:
• Fewer illnesses, injuries, fatalities,
and accidents due to a more consistent,
comprehensible, and clearer system that
does not require English literacy to
obtain some minimal hazard
information;
• Greater ease of use of SDSs; and
• Reduced training requirements for
workers due to a clearer and more
uniform system.
Because many of these benefits
require uniformity, and the benefits are
dispersed throughout a network of
producers and users, only some of
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which have direct market relationships
with each other, OSHA believes that
only a single, uniform standard can
achieve the full net benefits available to
a hazard communications system.
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C. Profile of Affected Industries
The proposed 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. Every
workplace in OSHA’s jurisdiction in
which employees are exposed to
hazardous chemicals is covered by the
HCS and is required to have a hazard
communication program.
The proposed revisions to the HCS are
not anticipated to either increase or
decrease the scope of affected industries
or establishments. The proposed
revisions define and revise specific
classifications and categories of hazards,
but the scope of the requirements under
which a chemical, substance, or mixture
becomes subject to the requirements of
the standard are not substantially
different from the current HCS.
Therefore, the proposed revisions
should have little or no effect on
whether an entire establishment falls
within the scope of the standard. OSHA
requests comments from the public
regarding this preliminary
determination.
For establishments with employees
exposed to hazardous chemicals, the
proposed revisions to the HCS would
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generally involve management
becoming familiar with and employees
receiving training on the new warning
labels and the new format of the SDSs.
For establishments producing or
importing hazardous chemicals,
generally as part of the chemical
manufacturing industry, the revisions to
the standard would involve
reclassifying chemicals in accordance
with the new classification system and
revising safety data sheets and labels
associated with hazardous chemicals.
OSHA’s estimates of the number of
employees covered by the standard are
based on the preliminary determination
that all production employees in
manufacturing would be covered, and
that, in addition, employees in other
industries working in any of the
occupations specified in the PP&E
report would also be exposed to
hazardous chemicals.
Table VII–2 provides an overview of
the industries and estimated numbers of
employees potentially affected by the
HCS. OSHA welcomes additional
information and data that may help
improve the accuracy of these estimates.
The industries and establishments
affected by the proposed revisions can
be divided into two categories. The first
category contains establishments that
are required to produce labels and SDSs;
the second category contains
establishments that do not produce
labels or SDSs but are required to
provide employee access to labels and
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SDSs, supplied by others, for the
chemicals to which their employees
may be exposed in the workplace. As
noted, OSHA has preliminarily judged
that SDSs for imported chemicals would
normally be produced in the country of
origin, and thus would not represent
expenses for importers or other US
firms.
As shown in Table VII–2,
approximately 75,000 firms, in over
90,000 establishments, create hazardous
chemicals (i.e., products, substances, or
mixtures) for which a label and an SDS
are required in accordance with the
OSHA HCS. Approximately 880,000
SDSs and corresponding container
labels would be potentially affected by
the proposed revisions to the HCS.
OSHA estimates that the adoption of
GHS through this proposal would not
significantly change the numbers of
labels and SDSs produced. OSHA
welcomes comment on this issue.
In many instances, firms may be
already producing several different
versions of SDSs and labels for the same
product to satisfy different regulatory
requirements in different jurisdictions,
including SDSs and labels consistent
with GHS criteria. For these products,
the proposed revisions to the OSHA
HCS would be satisfied relatively easily
and may result in a reduction in overall
compliance costs by reducing the
number of different labels and SDSs
needed for each affected product.
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OSHA requests comments from the
public regarding these preliminary
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conclusions and requests information
on the number and type of labels and
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SDSs that would be affected or
produced as a result of this proposal.
The second category of industries and
establishments affected by the proposed
revisions contains those that do not
produce SDSs but are required to
provide their employees with access to
SDSs supplied by others as part of a
hazard communication program
covering chemicals to which employees
may be exposed in the workplace. The
effects on these establishments would
generally involve promoting employee
awareness of and management
familiarization with the revisions to
SDSs and labels.
As shown in Table VII–2, an
estimated 38 million employees are
potentially exposed to hazardous
chemicals in these workplaces and are
covered by the OSHA HCS. Including
employees working in establishments
that produce SDSs, a total of 41 million
employees would potentially need to
become familiar with the proposed
revisions to SDSs and labels. As also
shown in Table VII–2, OSHA estimates
that there are over five million
workplaces where employees may be
potentially exposed to hazardous
chemicals. OSHA requests comments
and information from the public
regarding these estimates.
D. Benefits, Net Benefits, and CostEffectiveness
OSHA estimates that the
promulgation of the proposed revisions
would result in substantial benefits from
a variety of sources. OSHA’s estimates
of the benefits include improvements in
occupational safety and health and a
corresponding reduction in the annual
number of injuries, illnesses, and
fatalities sustained by employees from
exposure to hazardous chemicals;
reductions in costs for producers of
hazardous chemicals; increased
efficiencies in the handling and use of
hazardous chemicals; and other benefits
as described in this section. OSHA
requests comments and information
from the public regarding the nature and
extent of any benefits that may be
associated with the proposed revisions.
OSHA expects the proposed revisions
to the HCS would result in an increased
degree of safety and health for the
affected employees and to reduce the
number of accidents, fatalities, injuries,
and illnesses associated with exposure
to hazardous chemicals.
As explained in detail in Section V of
the preamble, the design of GHS was
based on years of extensive research that
demonstrated the effectiveness of
pictograms, specific signal words, and a
standardized format. As a result of this
research, OSHA is confident that the
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GHS revisions to the HCS standard for
labeling and safety data sheets would
enable employees exposed to workplace
chemicals to more quickly obtain and
more easily understand information
about the hazards associated with those
chemicals. Warning labels on products
covered by the standard, which provide
an immediate visual reminder of the
chemical hazards involved, would be
made more intuitive, self-explanatory,
and logical, and the nature and extent
of any associated hazards would be
more readily understood as a result of
the training required under the
proposal. Relatedly, the revisions are
expected to improve the use of
appropriate exposure controls and work
practices that can reduce the safety and
health risks associated with exposure to
hazardous chemicals.
In addition, the standardized format
of the safety data sheets would enable
critical information to be accessed more
easily and quickly during emergencies.
This can reduce the risk of injury,
illness, and death to exposed employees
and to rescue personnel and can reduce
property damage.
It is difficult to quantify precisely
how many injuries, illnesses, and
fatalities would be prevented due to the
proposed revisions to the HCS. The
benefits associated with the existing
HCS may help provide a general sense
of the potential magnitude of the
benefits of the proposed revisions to the
HCS. A discussion and analysis of the
benefits that would result from the
implementation of the existing OSHA
HCS were included as part of the
rulemaking process for the
promulgation of the existing standard in
the 1980s.
The existing HCS was originally
promulgated in two parts. First, a final
rule covering the manufacturing
industry was published in the Federal
Register in 1983 (48 FR 53280,
November 25, 1983); a second final rule
covering other general industries,
maritime industries, construction
industries, and agricultural industries
was published in the Federal Register
in 1987 (52 FR 31852, August 24, 1987).
For both of these final rules, OSHA
conducted research specifically
regarding the benefits that could be
expected from the promulgation of these
standards, as described in the preambles
to the final rules. In addition, through
the rulemaking process, OSHA
evaluated the best available evidence,
including the data and comments
submitted by the public.
The information, data sources,
analyses, and findings related to the
estimation of the benefits associated
with the standards are included in the
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public records for the rulemakings. The
complete rulemaking records for these
standards can be found in OSHA public
dockets H–022B and H–022D.
The estimated benefits associated
with the Hazard Communication
Standards were published in the
Federal Register with the promulgation
of the final standards (48 FR 53329,
November 25, 1983 and 52 FR 31872,
August 24, 1987). OSHA estimated that
compliance with the various Hazard
Communication Standards would
produce annual benefits that would
include the prevention of 31,841 nonlost-workday injuries and illnesses,
20,263 lost-workday injuries and
illnesses, 6,410 chronic illnesses, and
4,260 fatalities.
Using a willingness-to-pay approach
for valuing these benefits, OSHA
determined that the annual safety and
health benefits would be over $18.2
billion annually, expressed in 1985
dollars. According to the inflation
calculator provided by the Bureau of
Labor Statistics, the buying power of
$18.2 billion in 1985 is equivalent to the
buying power of about $35.3 billion in
2007 after adjusting for inflation of 94
percent over the period.5
Based on the material presented in
this preamble, OSHA expects that the
proposed revisions to the HCS would
result in incremental improvements in
employee health and safety above that
already achieved under the existing
HCS. For purposes of this proposal,
OSHA has selected an estimate of 1
percent of the health and safety benefits
due to the existing HCS as the benefits
that could be attributed to compliance
with the proposed revisions. It is
conceivable that actual benefits might
be somewhat lower, but because GHS is
expected to result, in some situations, in
more timely and appropriate treatment
of exposed workers, OSHA believes
actual benefits may be larger, perhaps
several times larger.6 7
5 https://data.bls.gov/cgi-bin/cpicalc.pl. BLS
inflation calculator used on September 23, 2008.
6 For example, one commenter on the ANPR,
representing an organization whose membership
includes first response and emergency management,
wrote the following: ‘‘The emergency planning and
first responder community depends upon MSDS
information for life and safety. The ability to
immediately examine an MSDS and glean hazard
and response information at the scene of an
incident is critically important. The lives of first
responders, employees of the facility and the public
depend upon the accuracy and ease of use of the
MSDS.’’ (Document ID # 0033.)
7 OSHA believes that a reasonable range for the
magnitude of the health and safety benefits
resulting from the proposed revisions would be
equal to between 0.5 percent and 5 percent of the
benefits associated with the existing HCS. These
ranges are considered in the sensitivity analysis
presented in Section VII.K.
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If the 1 percent estimate is correct,
then once all requirements take effect,
they would result in the prevention of
318 non-lost-workday injuries and
illnesses, 203 lost-workday injuries and
illnesses, 64 chronic illnesses, and 43
fatalities annually. The monetized value
of these health and safety benefits is an
estimated $353 million annually.
In order to obtain a sense of how
realistic these estimated safety and
health benefits are in light of the current
level of occupational injuries, illnesses,
and fatalities that are chemicallyrelated, OSHA reviewed relevant BLS
data for the periods 1992–2007. OSHA’s
examination of these data shows a 42
percent decline in chemically-related
acute injuries and illnesses over the
period, but both remain significant
problems—55,400 chemically-related
illnesses and 125 chemically relatedfatalities in 2007. However these readily
measurable reported acute illnesses and
fatalities are dwarfed by chronic
illnesses and fatalities. For chronic
illness fatalities, there is little
information available, and certainly no
annual time series data. The most recent
estimate is that there were 46,900 to
73,700 fatalities due to occupational
illnesses in 1992 (Leigh et al., 1997).
OSHA believes these more recent data
from 1992–2007 show that it is
plausible that HCS has had a desirable
effect on chemically-related illnesses
and injuries, but there remains a very
significant role for further and better
hazard information, as would be
provided by GHS.
OSHA requests information and data
from the public that could assist the
agency in more accurately determining
the safety and health benefits associated
with the proposed revisions.
The annual benefits associated with
the proposed revisions to the OSHA
HCS would generally begin after full
implementation of the changes and
associated employee training. The
phase-in period is expected to take
about three years. Thus, in order to
calculate the estimated annualized
benefits over a twenty-year period
associated with this proposed rule in a
manner that would be comparable to the
corresponding annualized costs, the
delay in the realization of the benefits
was incorporated into the calculation.
Using a discount rate of 7 percent, the
annual benefits beginning three years
after the effective date of the revisions
were multiplied by 0.7523 to calculate
the annualized benefits over a twentyyear period beginning with the effective
date of the final rule.8 Thus, the
8 The
formula for annualizing the benefits is equal
to:
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annualized monetized benefit associated
with the reduction in safety and health
risks attributable to the proposed
revisions is an estimated $266 million.
Other substantial benefits, in addition
to the improved occupational safety and
health of affected employees, are also
expected to result from this rulemaking,
as discussed in the following
paragraphs.
The harmonization of hazard
classifications, safety data sheet formats,
and warning labels for affected
chemicals and products would yield
substantial savings to the businesses
involved in these activities. Fewer
different SDSs would have to be
produced for affected chemicals, and
many SDSs would be able to be
produced at lower cost due to
harmonization and standardization. The
benefits represented by these cost
reductions would primarily affect
businesses involved in chemical
manufacturing.
In addition, reductions in operating
costs are also expected as a result of the
promulgation of the proposed revisions
for many businesses that purchase or
use hazardous chemicals. The current
non-uniformity of SDSs and labels
received by establishments in
practically all industries requires
employees and managers in numerous
positions to spend additional time on a
daily basis to ascertain the appropriate
way to handle and store the hazardous
chemicals in their workplace. Under the
revised standard, the presence of
uniform and consistent information
would help employers and employees to
make decisions more efficiently and
save substantial time.
PP&E conducted extensive research
on the processes that companies use to
classify chemical hazards, to develop
SDSs and labels, and to handle, store,
and use hazardous chemicals. PP&E
evaluated how these processes would be
affected by the proposed revisions to the
HCS and analyzed the potential savings
that would be realized as a result of
adopting these revisions.
Based on the PP&E report, OSHA
developed estimates of the cost
reductions that the affected companies
would expect to obtain as a result of the
proposed revisions to the OSHA HCS.
Among the various benefits expected to
be realized as a result of the
[(1.07)¥3] * [ (1¥(1.07)¥17)/0.07] * [0.07/
((1¥(1.07)¥20)],
where the first term in brackets reflects the three
year delay until annual benefits are realized; the
second term in brackets reflects the present value
of seventeen years of annual benefits (from years 4
through 20), and the third term in brackets
annualizes the present value of benefits over a 20year period.
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implementation of the proposed
revisions, as described in this section,
OSHA quantified two general categories
of cost savings. First, OSHA estimated
the number of hours that each industry
would save by improving the efficiency
and productivity of personnel who use
SDSs in performing their job functions.
OSHA estimated that the amount of
time spent during affected activities in
the manufacturing sector could be
reduced by 3 percent for health and
safety supervisors and by 15 percent for
logistics personnel specializing in
handling hazardous chemicals.9 OSHA
further estimated that this time
reduction, and the associated cost
savings, would apply to about 7,000
health and safety supervisors and
52,000 logistics personnel in the
manufacturing sector and would yield
annualized benefits of approximately
$569 million.10 Similar potential time
and cost savings as a result of the
proposed revisions to the OSHA HCS
were not quantified for the nonmanufacturing sectors.
Second, OSHA estimated that, for the
manufacturing sectors, the costs
associated with the creation and
revision of SDSs in future years would
be reduced by the proposed revisions.
The creation and revision of individual
SDSs would be less burdensome, and, in
addition, fewer different versions of
SDSs would need to be produced for
affected chemicals and products. OSHA
estimated that, depending on firm size,
the combination of these two effects
9 For example, as described by PP&E, the job of
a logistics person, depending on the company,
consists of the following tasks: (1) Receive
hazardous chemicals; (2) gather the associated
SDSs—either those that are attached to the
shipment or those that are attached to the invoice;
(3) extract the relevant information from the SDSs
and enter it in the plant’s SDS management system;
(4) insert paper copies of the SDSs into the (hard
copy) SDS management folder; (5) if the
information is not available (particularly in the
older 9-section SDSs), then look for 12-section SDSs
prepared by some other manufacturer; (6) prepare
in-plant labels; (7) determine special storage and
use requirements, make appropriate arrangements
for short-term and long-term storage, and distribute
information to different process lines or field
offices; (9) participate in the training of line
supervisors and production workers; (10) train new
employees; and (11) carry out other logistics duties
at the plant. The proposed GHS standard, by
making the structure and content of SDS uniform,
would help to reduce the time it takes to perform
each of the above tasks.
10 These estimates assume 2,000 hours of work a
year for 7,070 health and safety supervisors and
52,280 logistics personnel specializing in handling
hazardous chemicals in the manufacturing sector;
an hourly wage of $47; and a time savings of 3
percent and 15 percent, respectively, for health and
safety supervisors and logistics personnel. The
resulting annual savings of $757 million was
multiplied by 0.7523 to annualize the savings over
a twenty-year period with savings not accruing
until three years after the effective date of the
revisions.
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would result in annual savings
equivalent to between 2.5 and 4 hours
of a professional’s time per existing SDS
and a total annualized savings of $16
million.11
Combining the improved productivity
of personnel who use SDSs and the
improved efficiency of those who revise
SDSs and labels, OSHA concluded that
the annual cost savings for companies in
the manufacturing sector would be an
estimated $585 million.
A secondary benefit of the adoption of
GHS is that it would facilitate
international trade, increasing
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 resulting
from the harmonization and the
associated increase in international
competition, prices for the affected
chemicals and products, and the
corresponding goods and services using
them, should decline, although perhaps
only by a small amount.
The proposed revisions may also
result in reductions in the costs
associated with providing training for
employees as required by the existing
OSHA HCS. Companies would save
considerable time and effort in training
new employees in the future. The
potential savings would be attributable
in part to reducing or eliminating the
need to explain the different types of
formats used to convey hazard
information and the different types of
information included in the contents of
SDSs and labels.
Finally, the proposed GHS
modifications to the OSHA HCS would
meet the international goals for
adoption and implementation of the
GHS that were supported by the U.S.
government. Implementing GHS in U.S.
Federal laws and policies through
appropriate legislative and regulatory
action was anticipated by the U.S.
support of international mandates
regarding the GHS in the
Intergovernmental Forum on Chemical
Safety, the World Summit on
Sustainable Development, and the
11 These estimates assume 1⁄3 of the estimated
880,260 SDSs are reviewed each year; savings per
SDS is between 21⁄2 and 4 hours, depending on firm
size (with an average per SDS of about 3.2 hours);
personnel reviewing the SDSs receive an hourly
wage of $47; and existing compliance rates are
between 1 percent and 75 percent, depending on
firm size (with an average per SDS of about 53
percent). The resulting annual savings of $21
million was multiplied by 0.7523 to annualize the
savings over a twenty-year period with savings not
accruing until three years after the effective date of
the revisions.
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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.
Table VII–1 provides a summary of
the costs and benefits of the proposed
revisions to the OSHA HCS, and it
shows the net benefits and costeffectiveness of the revisions to the
standard. Net monetized benefits are
estimated to be $754 million annually.
The cost-effectiveness of the standard
can be expressed as more than eight
dollars of benefits for every dollar of
cost.
Some qualitative evidence of the costeffectiveness of the standard was
provided by comments submitted in
response to the Advance Notice for
Proposed Rulemaking (ANPR)
published by OSHA in the Federal
Register on September 12, 2006 (71 FR
53617). There was widespread (but not
unanimous) support among the
commenters for the adoption of GHS in
the United States. This included
commenters who provided some of the
largest estimates of the costs of the
proposed revisions. (Document IDs #
0032 and # 0050).12
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. In
fulfillment of this requirement, OSHA
has reviewed the requirements that
would be imposed by the proposal, and
has assessed their technological
feasibility. As a result of this review,
OSHA has determined that compliance
with the requirements of the proposal is
technologically feasible for all affected
industries. OSHA requests comments
and information from the public with
regard to this preliminary
determination.
The proposal would require
employers producing chemicals to
reclassify chemicals in accordance with
the new classification criteria and revise
safety data sheets and labels associated
with hazardous chemicals. Compliance
with these requirements is not expected
to involve any technological obstacles.
The proposal would also require
employers whose workplaces involve
12 One of these commenters is an international
trade association for the institutional and industrial
cleaning industry that represents over 4,600
manufacturer, distributor, building service
contractor, and in-house service provider members
worldwide. The other is a trade association
representing some 400 manufacturers of paints,
coatings, adhesives, sealants, and caulks, raw
materials suppliers to the industry, and product
distributors.
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potential exposure to hazardous
chemicals to train employees on the
relevant aspects of the revised approach
to hazard communication. Affected
employees would need additional
training to explain the new labels and
safety data sheets. Compliance with
these requirements is not expected to
involve any technological obstacles.
Compliance with all of the proposed
requirements can be achieved with
readily and widely available
technologies. Businesses in the affected
industries have long been required to be
in compliance with the existing HCS
which includes similar requirements.
The revised HCS would simply require
modifying the labels and SDSs for
hazardous chemicals and adding some
training to ensure employee
familiarization with the changes made.
Therefore, there are no new
technologies required for compliance
with the modifications. In addition,
some businesses in the affected
industries have already implemented
many of the requirements of the
proposed standard to varying degrees.
OSHA believes that there are no
technological constraints associated
with compliance with any of the
proposed requirements, and welcomes
comments regarding this conclusion.
F. Costs of Compliance
Introduction
This section presents the estimated
costs of compliance for the proposed
revisions to the OSHA HCS. The
estimated costs of compliance represent
the additional costs necessary for
employers to achieve full compliance.
They do not include costs associated
with current compliance with the new
requirements.
The compliance costs associated with
the proposal generally consist of the
one-time transition costs to adopt the
modified criteria for classifications and
formats as required under the new
system. Ongoing annual costs associated
with compliance with the existing
OSHA HCS are not expected to increase.
As discussed in the benefits section, the
adoption of the new system is expected
to reduce some of the ongoing costs
associated with compliance with the
HCS after the completion of the
transition period.
The costs of compliance with the
proposed revisions consist of three main
categories: the cost of reclassification
and revision of SDSs and labels, the cost
of training employees, and the cost of
management familiarization and other
management costs associated with the
administration of hazard
communication programs.
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The estimated compliance costs
associated with the proposed revisions
are based on a preliminary
determination that the revisions would
not significantly change the number of
chemicals or products for which an SDS
will be required, which also means that
there will be no change in the number
of establishments required to implement
a hazard communication program.
OSHA requests comments and
information from the public regarding
this preliminary determination.
Other than the direct costs of
reclassification and relabeling, the
estimated compliance costs do not
include any further 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
demand for products. Theoretically,
such impacts, if any, with regard to
possible changes in the uses and
applications of affected chemicals,
could be positive as well as negative.
OSHA has preliminarily determined
that such effects, if any, will not be
significant, and requests comments and
information from the public regarding
this determination.
In addition to the proposed revisions
to the HCS, the proposed rulemaking
also includes related proposed revisions
to other OSHA standards. The revisions
to the other standards generally ensure
that all OSHA requirements related to
hazard communication remain
consistent with each other and become
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consistent with the GHS. OSHA has
preliminarily determined that the
proposed revisions to the other
standards would not impose significant
costs beyond those reflected in the
preliminary compliance cost estimates
for this rulemaking, and requests
comments and information from the
public regarding this determination.
In order to have compliance costs
presented on a consistent and
comparable basis across various
regulatory activities, the costs of
compliance for this proposed rule are
expressed in annualized terms.
Annualized costs represent the more
appropriate measure for assessing the
longer-term potential impacts of the
rulemaking. The estimated annualized
cost of compliance is also provided for
purposes of comparing compliance costs
and cost-effectiveness across diverse
regulations with a consistent metric. In
addition, annualized costs are often
used for accounting purposes to assess
the cumulative costs of regulations on
the economy or specific parts of the
economy across different regulatory
programs or across years. Annualized
costs also permit costs and benefits to be
presented in a comparable manner. The
annualized cost was calculated by
annualizing the one-time transition
costs over a period of 20 years and
applying a discount rate of 7 percent.
Table VII–3 shows the estimated
annualized compliance cost by cost
category and by industry sector. As
shown in Table VII–3, the total
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annualized cost of compliance with the
proposed rulemaking is estimated to be
about $97 million. Of this amount, the
cost of chemical hazard reclassification
and revision of SDSs and labels is an
estimated $11 million, the cost of
training employees is an estimated $44
million, and the cost of management
familiarization and other management
costs is an estimated $42 million.
As shown in Table VII–3, most of the
compliance cost associated with
chemical hazard reclassification and
revision of SDSs and labels would be
borne by the chemical manufacturing
industry. Table VII–3 also shows that
compliance costs are spread across all
industries in the U.S. economy subject
to OSHA jurisdiction, reflecting the fact
that employee exposures to hazardous
chemicals occur in almost every
industry sector.
OSHA expects that the compliance
costs would be incurred over a period
of three years, as the proposal would
incorporate a three-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
employee training would be incurred in
the two-year period following the
effective date of the final standard, and
that other compliance costs would be
incurred in the three-year period
following the effective date of the final
standard.
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In order to make the compliance cost
estimates comparable with the
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corresponding benefits estimates, the
expected timing of these costs was taken
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into account. A seven percent discount
rate was applied to costs incurred in
future years to calculate the present
value of these costs 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 20-year period, to calculate the
$97 million annualized costs.
In the appendix to this cost section,
Table VII–4 shows, by industry and by
cost element, total non-annualized (nondiscounted) compliance costs of about
$1.1 billion estimated to be incurred
during the three-year phase-in of the
proposed revisions.
Estimation of Compliance Costs
The remainder of this section explains
how the compliance costs were
calculated by describing the data and
methodology used to estimate each of
the major cost elements. A more
complete and detailed description of the
estimation of compliance costs can be
found in the PP&E report.
The major elements of the proposed
revisions that involve compliance costs
include (1) the classification of
chemicals in accordance with the
proposed criteria and the revisions to
the safety data sheets and labels
corresponding to the affected hazardous
chemicals; (2) incremental training for
employees already trained under the
existing OSHA hazard communication
programs to ensure their familiarization
with the new formats, information, and
symbols that would be introduced into
the workplace as a result of the
proposed revisions; and in addition, (3)
even though it is not directly a result of
any specific requirement included in
the proposed revisions, the cost for
managers and administrators of hazard
communication programs to become
familiar with the revisions to the
standard and to manage, update, and
revise their programs as may be
necessary to ensure compliance with the
revised standard.
The estimated compliance costs
presented in this analysis of the
proposed revisions to the HCS are
largely based on research conducted by
PP&E. PP&E performed this research
under contract to the Department of
Labor specifically for the purpose of
developing estimates of compliance
costs for, and assessing the potential
impacts that may be associated with,
possible revisions that may be made to
the OSHA HCS in order to implement
the GHS.
The estimated costs of compliance
with many of the provisions of the
proposed standard involve wages paid
for the labor hours required to fulfill the
requirements. In some cases,
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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.
Costs Associated With Chemical
Classifications and Revisions to Safety
Data Sheets and Labels
The proposed revisions to the OSHA
HCS would continue to require firms
that sell hazardous chemicals to
employers to provide information about
the associated hazards. Information is
required to be presented in a safety data
sheet (SDS) in the format specified in
the revised standard, and some
information is also required to be
presented on product labels.
The existing OSHA HCS already
requires information about hazardous
chemicals to be provided in SDSs and
on labels. In addition, under the existing
standard, SDSs are to be revised after a
manufacturer or employer becomes
aware of any significant new
information about the hazards of a
chemical.
The proposed revisions to the
standard would require chemicals to be
classified into the appropriate hazard
classes and categories based on the
information about the chemicals that the
manufacturers currently have. This
information would have been assembled
for purposes of conducting a hazard
determination under the current HCS. In
addition, the current HCS requires
chemical manufacturers and importers
to remain aware of developments
regarding the hazards of the chemicals
they produce or import in order to
update the labels and SDSs for the
chemicals in a timely manner. The
classification of the chemicals into the
hazard classes and categories under the
revised provisions would not require
any additional testing, studies, or
research to be conducted. Manufacturers
would be able to rely on the information
they already have in determining how to
properly classify their chemicals.
Generally, chemical manufacturers
and importers periodically review,
revise, and update SDSs and labels.
Changes are made as necessary as
information regarding specific hazards
develops, new information about
protective measures is ascertained, or
changes are made to product
information and marketing materials.
Labels and SDSs must also be produced
or modified when products are
introduced or changed. Therefore, there
is a regular cycle of change for these
documents for a variety of reasons. The
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proposed revisions may require a more
extensive change than would normally
occur, but the phase-in period is such
that the chemical manufacturers and
importers can take advantage of the
normal cycle of change to phase in the
revisions for all their products over a
reasonable time period. This should
have less impact on normal operations
than a short time period that would
require all SDSs and labels to be revised
at the same time.
The transition period that would be
allowed by the delayed effective date for
the requirement to adopt the new format
should help ensure that the transition
can be completed in conjunction with
revisions and updates that would
normally be expected to occur even
without the implementation of the
proposed revisions. In addition, the
format required by the proposed
revisions for SDSs is consistent with the
format already adopted by the American
National Standards Institute (ANSI) and
therefore has already been implemented
by many of the affected businesses.
Based on the PP&E report, OSHA
developed estimates of the costs that
would be associated with the
classification of chemicals in
accordance with the proposed criteria
and with the revisions to the
corresponding SDSs and labels for those
chemicals. The estimated compliance
costs represent the incremental costs
that would need to be incurred to
achieve compliance with the proposed
revisions; these estimated costs would
be in addition to the costs that would
already be incurred to continue to
remain in compliance with applicable
requirements of the existing HCS.
The proposed revisions would allow
for a transition period of three years
following the publication of a final rule.
During this period, even in the absence
of any pertinent OSHA rulemaking,
producers of affected chemicals would
presumably be ensuring that the
information provided in their SDSs and
labels remains accurate and current.
Producers of hazardous chemicals are
generally expected to regularly review
the available information regarding any
hazards that may be associated with
their products and to revise SDSs and
labels accordingly.
In addition, 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, the
chemical producer would be required
under existing OSHA and other
applicable standards to review the
available hazard information, to classify
the chemical in accordance with
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applicable hazard criteria, and to
develop corresponding SDSs and labels.
The estimated costs of compliance
with the proposed revisions do not
include the costs associated with
activities such as those described in the
above paragraphs, but rather reflect only
the additional costs that chemical
producers would not already be
expected to incur.
The estimated compliance costs
associated with the proposed
reclassification of hazards and changes
to SDSs and labels are based on the
numbers of SDSs affected. Based on the
PP&E report, OSHA developed estimates
of the number of potentially affected
SDSs by industry, for each of the
industries producing the corresponding
chemicals and products (as shown in
Table VII–2). Downstream users,
distributors, and wholesalers are
expected to continue to rely on SDSs
provided by manufacturers to fulfill
their obligations under the OSHA
standard, as has been the practice for
decades. OSHA requests comments and
information from the public regarding
this aspect of compliance with the
standard.
The costs of compliance associated
with the classification of chemicals in
accordance with the proposed criteria
and with the revisions to the
corresponding SDSs and labels for those
chemicals were based on PP&E industry
interviews and estimated as follows.
Generally, for smaller establishments
with relatively few chemicals affected,
OSHA estimated the incremental
compliance costs to be the equivalent of
the cost of seven hours of time of a
professional with the requisite expertise
for each affected chemical, on average.
Based on the PP&E report, OSHA
estimated the cost of hourly
compensation for a professional for this
purpose to be $47. As a result, a small
establishment (with fewer than 100
employees) with 20 SDSs for 20
chemicals, for example, would have
estimated incremental compliance costs
of $6,580 (7 hours times 20 SDSs times
$47).
In larger establishments with more
affected chemicals, the incremental
compliance costs were estimated to
consist of two parts. First, labor costs
were estimated according to the size of
the establishment. OSHA, based on
PP&E interviews with stakeholders,
estimated that entities with 100 to 499
employees would incur, on average, the
equivalent of five hours of time of a
professional with the requisite expertise
for each affected chemical, and that
entities with 500 or more employees
would incur the equivalent of three
hours of professional time per chemical.
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Based on the PP&E report, OSHA
estimated the hourly compensation for a
professional for this purpose to be $47.
The labor cost per SDS was estimated
to be lower for larger companies based
on the determination that larger
companies produce more SDSs, and
would therefore experience efficiencies
associated with producing them. These
efficiencies include economies of scale,
the use of software specifically designed
to classify hazards and produce SDSs,
and the generally lower cost per SDS
associated with many mixtures.
Second, many of these larger
establishments may incur additional
expenditures to purchase or modify
software that can be used to classify
chemicals and to produce
corresponding SDSs and labels. Such
software is available from a variety of
vendors; the software can be purchased
or used on a subscription basis. Publicly
available information about the
products and services being offered and
sold to businesses for purposes of
complying with hazard communication
requirements indicates that most of the
relevant vendors are aware of and
prepared for an upcoming transition to
the GHS, and that their products and
services are or will be adapted to enable
compliance with the proposed
revisions. In addition, some firms may
purchase custom or proprietary software
from private vendors to achieve
compliance with existing or proposed
revisions to hazard communication
requirements and for other purposes.
Regardless of the particular approach
individual companies may choose to
most efficiently fulfill their obligations
under the existing or proposed HCS,
OSHA expects that a part of the costs
associated with achieving compliance
with the proposed revisions would
involve costs attributable to software
modifications. Based on industry data
obtained by PP&E, OSHA apportioned
these costs on a per-SDS basis and
estimated the cost per SDS to be $200,
on average.
Based on the PP&E report, OSHA
estimated the numbers of SDSs
produced in each industry that would
potentially need to be revised under the
proposed standard, as shown in Table
VII–2. A total of about 880,000 SDSs,
one for each type of chemical produced
by an individual manufacturer in the
United States, were estimated to be in
potential need of revision.
In developing estimates of the
compliance costs associated with the
proposed rule, PP&E also considered the
extent to which many firms have
already performed the necessary
reclassifications of chemical hazards
and revisions to SDSs. Some chemical
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hazards have already been reclassified
as would be required by the proposed
OSHA standard because the U.S.
Department of Transportation has
required such classifications as part of
their regulations for the transportation
of hazardous chemicals (49 CFR parts
171–180). The criteria for physical
hazard classifications for purposes of
transport have been internationally
harmonized for some years, and these
criteria formed the basis for the physical
hazard criteria in the GHS. Therefore,
many products intended for transport
have already been classified under the
new proposed physical hazard criteria
as well as the existing criteria in the
HCS.
Many current SDSs are already
produced to varying degrees in
accordance with the requirements of the
proposed OSHA standard because the
widely-followed ANSI industry
consensus standard already reflects
many of these requirements in its
relevant criteria. In addition, many
firms have implemented or are
beginning to implement hazard
reclassifications, SDS revisions,
software modifications, and other
changes in accordance with the
requirements of the proposed OSHA
standard, because these provisions are
generally anticipated to be adopted as
part of the implementation of the GHS
in countries and regions around the
world. Since some other countries are
already implementing the GHS,
companies in the U.S. that ship to those
countries are already having to comply
with the GHS for products being
exported.
Research conducted by PP&E
indicates that all of these factors
contribute to a substantial degree of
current compliance with the proposed
rule, even if the existing OSHA standard
remains unchanged.13 Based on the
PP&E report, OSHA estimates that, on
average, about 53 percent of the gross
costs that would otherwise be associated
with the proposed revisions to the HCS
have already been incurred by firms.
However, this average is a result of very
different levels of current compliance
for different sizes of firms. PP&E
estimated that the percentage of firms in
current compliance with the proposed
revisions—with the exception of
employee training—is 75 percent for
firms with over 500 employees; 25
percent for firms with 100 to 500
employees; 5 percent for firms with 20
13 By current compliance, OSHA means firms that
have already reclassified chemicals and prepared
SDSs and labels in accordance with proposed GHS
requirements and would therefore be ready to
introduce these modifications at negligible
additional cost when GHS becomes effective.
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to 99 employees; and 1 percent for firms
with fewer than 20 employees. OSHA
used these percentages to reduce the
number of firms reported in Table VII–
2 for purposes of estimating the costs for
affected firms to comply with the
proposed revisions (again, with the
exception of employee training).
Based on the preceding analysis,
OSHA estimates an annualized cost of
approximately $11 million for the
classification of chemicals in
accordance with the proposed criteria
and for revisions to the corresponding
SDSs and labels for those chemicals.14
OSHA requests data and information
from the public that would assist the
Agency in ensuring that any costs
associated with the proposed revisions
are accurately estimated. For example,
OSHA would appreciate data from
individual companies on the number of
actively distributed SDSs; the number
that would be affected by the GHS
proposal; the time required to revise
SDSs; the occupation and hourly cost of
the individuals working on the
revisions; and whether software would
need to be modified or purchased and
the costs of the modification or
purchase.
As discussed below, OSHA received
some comments from the public
regarding the estimated costs associated
with chemical classifications and
revisions to safety data sheets in
response to the Advance Notice for
Proposed Rulemaking (ANPR)
published by OSHA in the Federal
Register on September 12, 2006 (71 FR
53617). The comments received are
publicly available as part of the
rulemaking record, accessible through
regulations.gov, in docket OSHA–
H022K–2006–0062. Relevant
information submitted by the public
was incorporated into the development
of the methodology and estimates
14 This annualized estimate of $11 million reflects
software costs of $32 million and labor costs of
$100 million multiplied by 0.082573 to annualize
these costs (incurred over the first three years) over
a 20-year period. The $32 million in software costs
is the result of about 160,000 modified SDSs
[(574,000 SDSs for large establishments × 25% not
in existing compliance × 95% requiring
modification) + (128,000 SDSs for establishments
with 100–500 employees × 75% not in existing
compliance × 25% requiring modification)] at a cost
of $200 per SDS. The $100 million in labor cost is
the result of about 413,000 affected SDSs multiplied
by an average of 5.14 hours per SDS (from 3 to 7
hours per SDS) multiplied by $47 per hour.
The annualization factor, 0.082573, is equal to:
[(1⁄3] * [ (1—(1.07)¥3)/0.07] * [0.07/((1—
(1.07)¥20)],
where the first term in brackets reflects the fact
that these costs are assumed to be spread equally
over the first three years; the second term in
brackets calculates the present value of the costs,
and the third term in brackets annualizes the
present value of the costs over a 20-year period.
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presented in this preliminary economic
analysis.
Some commenters provided examples
of cost estimates that generally support
the estimates of the preliminary
economic analysis. Information from
other commenters provided a wide
range of cost estimates. The figures
presented in some comments appeared
to correspond to gross costs of creating
SDSs, and in other cases it was not clear
whether gross or incremental costs were
being presented. In general, commenters
did not provide the rationale underlying
their cost estimates. OSHA requests
that, in submitting any data or
information on compliance costs,
commenters distinguish between the
costs attributable to compliance with
existing requirements, costs already
incurred voluntarily or in compliance
with another standard, and the
incremental costs attributable to the
new requirements associated with this
rulemaking. The rationale or basis for
assigning these compliance costs would
also assist OSHA in developing accurate
cost estimates.
One commenter, the Fragrance
Materials Association of the United
States, stated that its best assessment is
that it would take anywhere from two to
eight hours to review information and
prepare new labels and safety data
sheets for each hazardous chemical.
(Document ID # 0061). Another
commenter, the Flavor and Extract
Manufacturers Association of the United
States, also reported that it would take
from two to eight hours to review the
necessary information and produce new
labels and safety data sheets for each
hazardous chemical. (Document ID #
0062).
One company that produces and
distributes about 4,000 different
hazardous chemicals estimated that it
will take four to six hours per product
to prepare a GHS SDS. (Document ID #
0026).
The National Paint and Coatings
Association stated that it would take
approximately five hours to research the
information for a product SDS/label at
a small company, at a cost of about $300
per product; it also estimated that, at a
medium-sized company, this same task
would take from 3–5 days to 3 weeks at
a cost of approximately $1,000 to
$1,800, and that at a larger company, the
task would be even more expensive.
(Document ID # 0050).
The National Association of Chemical
Distributors estimated that converting
an existing SDS to the new GHS format
would require about 150 hours as
compared to about 100 hours currently
to revise an MSDS. (Document ID #
0060).
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Another commenter, Merck, which
produces, imports, or distributes about
500 hazardous chemicals annually,
estimated that, on average, it takes
approximately 3 weeks to generate a
single safety data sheet at an average
cost of $1,500. Merck also stated that
with a sufficient transition period of
three to six years, the costs of moving
to GHS would be minimal. Merck noted
that the time and cost for additional
changes to the GHS format should be
minimal because it had already
converted its SDSs to the 16-section
ANSI/GHS format several years ago.
(Document ID # 0072).
One trade association estimated that
the costs associated with revising SDSs
and labels for the 1,600 firms in the
cleaning product formulator industry
would total $575 million, not including
the time needed to review changes to
hazard classifications. The total
numbers of SDSs per establishment are
generally higher for the establishments
represented by the trade association
than the OSHA estimates for the
industry category as a whole.
(Document ID # 0032).
This trade association also provided
some of the details underlying its cost
estimates for individual companies.
Cost estimates provided by the trade
association for individual companies
included costs per SDS as low as $30
and $80, and as high as $600 or more.
One company (identified as Company
#11) estimated the cost to revise the
label and SDS would be $120 per
product; another company (Company
#2) estimated that this cost would be
$2,600 per product. Some of the higher
compliance cost estimates appear to be
unrealistically high; for example, the
estimated costs associated only with
revising labels for company #3 appear to
represent about 3 percent of total annual
sales. While acknowledging that some
firms may incur higher costs than others
to revise SDSs and labels, these data
generally appear to support that, at least
for several firms in the industry, the
costs minimally necessary to achieve
compliance would be close to or less
than the costs estimated by OSHA.
Several other commenters provided
cost estimates related to the adoption of
GHS requirements for chemical
classifications and revisions to safety
data sheets and labels. See, for example,
Document ID #s 0015, 0018, 0024, 0036,
0079, 0105, 0107, 0116, 0128, 0141, and
0145, among others. Many estimates are
broadly consistent with OSHA’s
estimates; in addition, some estimates
appear to be similar to, but may actually
be substantially lower than, OSHA’s
estimates to the extent they include
costs attributable to the existing
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standard rather than just the
incremental costs associated with the
proposed modifications. Other estimates
are substantially higher, but many of
these also appear to represent gross
costs associated with fulfilling hazard
communication requirements without
consideration of the incremental nature
of the compliance costs for the proposed
revisions, as discussed above.
OSHA requests additional comments
and information from affected
establishments and from the public
regarding the nature of the incremental
costs of classifying chemicals and
modifying SDSs and labels associated
with the proposed revisions. Comments
would be most helpful to the Agency if
they included the underlying data and
methodology used to develop the cost
estimates.
Management Familiarization and Other
Management-Related Costs
The implementation of GHS as part of
the OSHA HCS would require that
employees currently covered by the
standard become familiar with the new
system. The nature and extent of the
familiarization required would vary
depending on an employee’s job and
business. OSHA considered separately
various training needs that may be
imposed by the proposed revisions.
Although it would not be explicitly
required by the proposed revisions,
some establishments may choose to
provide training to managers and other
employees that are not directly covered
by the training requirements of the HCS.
Other management-related costs may
include revisions, if necessary, to
existing hazard communication
programs; promoting awareness of and
providing information about the
revisions to hazard communication
programs; coordinating and integrating
changes to hazard communication
programs with other programs,
processes, and functions; serving as an
in-house resource for supporting the
general adoption of GHS; creating
supplemental capacity for providing
training and assistance to affected
employees; and other ancillary costs for
company-specific changes and general
hazard communication program
administration that may be incurred at
some establishments.
These costs could be considered
discretionary in that they would not be
explicitly required by the proposed
regulatory provisions; however, OSHA
recognizes that these costs may be
incurred in practice due to the manner
in which some companies have
implemented and integrated hazard
communication programs in their
facilities. The particular circumstances
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that would cause these costs to be
incurred partly reflect the fact that
hazard communications programs often
are not implemented solely for purposes
of complying with the OSHA standard,
but may serve a variety of other
purposes that are part of and that benefit
the overall production process.
In some cases, health and safety
supervisors, logistics personnel, and
other personnel involved in
administering, implementing, and
ensuring compliance with the
requirements of the HCS in affected
establishments would be expected by
company managers to become familiar
with the proposed revisions. The
responsibilities of these employees may
include modifying written hazard
communication programs as necessary,
reviewing and preparing training
materials, and training new and existing
employees regarding the changes. An
estimated 8 hours of time, 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.
In many potentially affected
establishments that do not produce
SDSs, and that have few affected
chemicals or few affected employees, a
very basic hazard communication
program may achieve compliance with
the OSHA standard. For these
establishments, outside of the
manufacturing sector, that have a health
and safety supervisor, the incremental
management and administrative costs
associated with the proposed revisions
to the OSHA standard were estimated to
be 2 hours per establishment. For
establishments outside of the
manufacturing sector that do not have a
health and safety supervisor, OSHA
estimated that these costs would be
negligible.
Based on the preceding analysis,
OSHA estimates an annualized cost of
approximately $42 million for
management familiarization and other
related management activities in
response to GHS.15
15 This annualized estimate of $42 million reflects
total costs of $490 million multiplied by 0.085332
to annualize these costs (incurred over the first two
years) over a 20-year period. The $490 million is
equal to $5.9 million for health and safety managers
(5,900 affected managers × $1000 per manager) plus
$16.4 million for logistics personnel in
manufacturing (43,600 affected logistics persons ×
8 hours × $47 per hour) plus $116 million for health
and safety supervisors in manufacturing (309,000
affected health and safety supervisors in
manufacturing × 8 hours × $47 per hour) plus
$351.7 million for health and safety supervisors in
non-manufacturing (3,740,000 affected H&S
supervisors in non-manufacturing × 2 hours × $47
per hour).
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OSHA requests additional comments
and information from affected
establishments and from the public
regarding the nature of the incremental
management familiarization costs
associated with the proposed revisions.
Costs Associated With Training
Employees
Production employees who are
currently covered by and trained under
the provisions of the existing HCS
would need to receive some additional
training to become familiar with the
proposed changes to SDSs and labels.
In many potentially affected
establishments that do not produce
SDSs, and that have few affected
chemicals or few affected employees, a
very basic hazard communication
program may achieve compliance with
the OSHA standard. In these
establishments, the incremental
employee training costs associated with
the proposed revisions to the OSHA
standard may be relatively small. In
other cases, employers may be able to
integrate the necessary training into
existing training programs and other
methods of distributing safety and
health information to employees, and
thus may not incur much additional
cost. Nevertheless, in order to
adequately reflect the opportunity costs
of devoting time and resources to the
necessary training, and in order to
ensure that the estimated compliance
costs reflect an adequate emphasis on
the familiarization with the proposed
new hazard communication system, a
more substantial training cost was
estimated.
An estimated 30 minutes of training,
in addition to training that would
otherwise be received, would provide
adequate time for employees to become
familiar with the new system. For some
occupations for which the use of
hazardous chemicals is minimal and the
number of hazards for which training is
needed is small, OSHA estimated that
15 minutes of training would be
sufficient. For some occupations in the
transportation sector, where GHS
pictograms are already in use, OSHA
estimated that only 5 minutes of
training would be needed. A complete
occupation-by-occupation review of
OSHA’s estimates is provided in the
PP&E report.
The annualization factor, 0.085332, is equal to:
[(1⁄2] * [ (1¥(1.07)¥2)/0.07] * [0.07/
((1¥(1.07)¥20)],
where the first term in brackets reflects the fact
that these costs are assumed to be spread equally
over the first two years; the second term in brackets
calculates the present value of the costs, and the
third term in brackets annualizes the present value
of the costs over a 20-year period.
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The training costs associated with the
proposed revisions are expected to be
incurred during the transition to the
new hazard communication system.
Compliance with the proposed revisions
is not expected to involve any
additional training costs after the
transition period.
Based on the preceding analysis,
OSHA estimates that the annualized
cost of training employees in response
to GHS would be approximately $44
million.16
The proposed revisions may result in
reductions in the costs associated with
providing training for employees as
required by the existing OSHA HCS.
Affected companies could save
considerable time and effort in training
new employees in the future. The
savings may be attributable in part to
reducing or eliminating the need to
explain the different types of formats
used to convey hazard information and
the different types of information
included in the contents of SDSs and
labels. OSHA did not quantify these
potential savings in training costs
associated with the proposed revisions.
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16 This annualized estimate of $44 million reflects
total costs of $519 million multiplied by 0.085332
to annualize these costs (incurred over the first two
years) over a 20-year period. The $519 million is
equal to $444 million in employee hours to receive
training (40.6 million affected employees × 0.42
hours × $26 per hour) plus $75 million in
management hours to provide the training (3.8
million managers × 0.42 hours × $47 per hour). The
0.42 hours is the average estimated training time for
all affected employees, with most receiving 30
minutes of training, some receiving 15 minutes of
training, and a very few receiving 5 minutes of
training. The total number of managers providing
training (3.8 million) would, on average, be equal
to approximately 9.4 percent of the number of
employees receiving training in response to GHS.
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OSHA requests additional comments
and information from affected
establishments and from the public
regarding the nature of the incremental
training costs associated with the
proposed revisions.
Summary of Unit Cost Estimates
The following list provides a
summary of the input estimates
underlying the calculation of the
compliance costs. It should be noted
that these costs are intended to reflect
only the incremental costs that would
be incurred in addition to the associated
costs that would be incurred in the
absence of the proposed revisions to the
standard. Except for employee training,
these costs would apply only to those
businesses not already in compliance
with the proposed revisions. OSHA
requests comments and information
from the public regarding these
estimates.
Reclassifying chemicals and
modifying SDSs and labels:
• Large establishments (over 500
employees): An average of 3 hours per
SDS; in addition, for 95 percent of
establishments, an average of $200 per
SDS for software modifications.
• Medium establishments (100–499
employees): An average of 5 hours per
SDS; in addition, for 25 percent of
establishments, an average of $200 per
SDS for software modifications.
• Small establishments (1–99
employees): An average of 7 hours per
SDS.
Management familiarization and other
costs:
• Eight hours for health and safety
managers and logistics personnel in the
manufacturing sector.
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• Two hours for each hazard
communication program manager not in
the manufacturing sector.
Employee training:
• 30 minutes per production
employee in most industries;
• 15 minutes in occupations exposed
to few hazardous chemicals and types of
hazards;
• 5 minutes per employee in some
occupations where GHS-type
pictograms are already in use.
Appendix to Section F: Total Nonannualized Costs of Compliance
Table VII–4 shows the total nonannualized (non-discounted)
compliance costs by industry and by
cost element that are estimated to be
incurred during the three-year phase-in
of the proposed revisions. Except for
employee training, these estimates
include no costs for businesses already
in compliance with the proposed
revisions.
As shown in Table VII–4, the total
cost of compliance with the proposed
rulemaking over the course of the
transition period of three years is
estimated to be about $1.14 billion. This
amount also represents the total nonannualized cost of compliance for the
proposed rule. Of this amount, the cost
of chemical hazard reclassification and
revision of SDSs and labels is an
estimated $132 million, the cost of
training employees is an estimated $519
million, and the cost of management
familiarization and other costs such as
updates to hazard communication
programs is an estimated $490 million.
BILLING CODE 4510–26–P
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G. Economic Feasibility and Impacts
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This section presents OSHA’s analysis
of the potential economic impacts of the
proposal and an assessment of economic
feasibility. A separate analysis of the
potential economic impacts on small
entities (as defined in accordance with
the criteria established by the Small
Business Administration) 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.
In order to assess the nature and
magnitude of the economic impacts
associated with compliance with the
proposal, 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 F of this economic analysis
were compared with industry revenues
and profits to provide a measure of
potential economic impacts.
Table VII–5 presents data on revenues
and profits for each affected industry
sector, along with the corresponding
estimated annualized costs of
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compliance in each sector. Potential
impacts in the table are represented by
the ratios of compliance costs to
revenues and compliance costs to
profits.
As is evident from the data and
estimates presented in Table VII–5, the
costs of compliance for the proposal are
not large in relation to the
corresponding revenues and profits in
each of the industry sectors. The
estimated costs of compliance represent
about 0.0004 percent of revenues and
about 0.00712 percent of profits on
average across all entities; compliance
costs do not represent more than 0.02
percent of revenues or more than 0.3
percent of profits in any individual
industry sector.
The Agency preliminarily concludes
that the proposal is economically
feasible for the affected industries. In
general, the courts have held that a
standard is economically feasible if
there is a reasonable likelihood that the
estimated costs of compliance ‘‘will not
threaten the existence or competitive
structure of an industry, even if it does
portend disaster for some marginal
firms’’ (United Steelworkers of America
v. Marshall, 647 F.2d 1189, 1272 (D.C.
Cir. 1980)). The potential impacts of
employer costs associated with
achieving compliance with the proposal
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fall well within the bounds of economic
feasibility in each industry sector.
OSHA does not expect compliance with
the requirements of the proposal to
threaten the viability of employers or
the competitive structure of any of the
affected industry sectors.
The economic impact of the proposal
is most likely to consist of a very small
increase in prices for affected hazardous
chemicals, of about 0.0004 percent on
average. Chemical manufacturing
companies, all of whom must incur the
costs of compliance unless they are
already doing so, should be able to pass
through costs to customers. The
additional costs of a one-time change to
revised SDS and labeling criteria are
extremely small in relation to the value
of the corresponding products, and
there are generally no economic
substitutes, or alternatives, that would
not be subject to the same requirements.
It is unlikely that a price increase of this
magnitude would significantly alter the
types or amounts of goods and services
demanded by the public or any other
affected customers or intermediaries. If
the compliance costs of the proposal can
be substantially recouped with a
minimal increase in prices, there would
be little or no effect on profits.
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In profit-earning entities, compliance
costs can generally be expected to be
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increases in prices or reduction in
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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 greater degree of 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.
In the case of cost increases that may
be incurred due to the requirements of
the proposal, all businesses within each
of the covered industry sectors would be
subject to the same requirements. Thus,
to the extent potential price increases
correspond to costs associated with
achieving compliance with the
standards, the elasticity of demand for
each entity will approach that faced by
the industry as a whole.
Given the small incremental increases
in prices potentially resulting from
compliance with the proposed
standards 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.
OSHA expects the economic impact
of the proposed rulemaking to be both
an increase in the efficiency of
production of goods and services and an
improvement in the welfare of society.
First, as demonstrated by the analysis
of costs and benefits associated with
compliance with the requirements of the
proposal, OSHA expects that societal
welfare will increase as a result of these
standards, as the benefits exceed the
necessary compliance costs. The
proposal is estimated to yield net
benefits of over $500 million annually
that would be achieved in a costeffective manner.
Second, until now, many of the costs
associated with the injuries, illnesses,
and fatalities resulting from the risks
addressed by the proposal have been
externalized. For example, the costs
incurred by society to supply certain
products and services that are
accompanied by injuries, illnesses, or
fatalities from employee exposure to
hazardous chemicals have not been
fully reflected in the prices of those
products and services. To the extent that
fewer of these costs are externalized
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because of improved employer and
employee information about hazardous
chemicals in the workplace, the price
mechanism will enable the market to
produce a more efficient allocation of
resources. However, reductions in
externalities by themselves do not
necessarily increase efficiency or social
welfare unless the costs of achieving the
reductions (including indirect and
unintended consequences of regulatory
approaches) are outweighed by the
associated benefits, as they are in this
instance.
In addition, based on an analysis of
the costs and economic impacts
associated with this rulemaking, OSHA
preliminarily concludes that the effects
of the proposal on employment, wages,
and economic growth for the United
States would be negligible. The effects
on international trade are expected to be
small but not negligible, because of the
increased import and export
opportunities with U.S. trading partners
arising from harmonization of the U.S.
system with GHS. Hence, the primary
effect on international trade is likely to
be beneficial.
OSHA requests comments from the
public regarding these preliminary
conclusions and requests information
on whether and how much this proposal
would affect international trade.
Statement of Energy Effects
As required by Executive Order
13211, and in accordance with the
guidance for implementing Executive
Order 13211 and with the definitions
provided therein as prescribed by the
Office of Management and Budget
(OMB), OSHA has analyzed the
proposed standard with regard to its
potential to have a significant adverse
effect on the supply, distribution, or use
of energy.
As a result of this analysis, OSHA has
determined that this action is not a
significant energy action as defined by
the relevant OMB guidance.
H. Initial Regulatory Flexibility
Screening Analysis
The Regulatory Flexibility Act, as
amended in 1996, requires the
preparation of an Initial Regulatory
Flexibility Analysis (IRFA) for proposed
rules where there would be a significant
economic impact on a substantial
number of small firms. (5 U.S.C. 601–
612). Under the provisions of the law,
each such analysis shall contain:
1. A description of the impact of the
proposed rule on small entities;
2. A description of the reasons why
action by the agency is being
considered;
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3. A succinct statement of the
objectives of, and legal basis for, the
proposed rule;
4. A description of and, where
feasible, an estimate of the number of
small entities to which the proposed
rule will apply;
5. A description of the projected
reporting, recordkeeping and other
compliance requirements of the
proposed rule, including an estimate of
the classes of small entities which will
be subject to the requirements and the
type of professional skills necessary for
preparation of the report or record;
6. An identification, to the extent
practicable, of all relevant Federal rules
which may duplicate, overlap or
conflict with the proposed rule; and
7. A description and discussion of any
significant alternatives to the proposed
rule which accomplish the stated
objectives of applicable statutes and
which minimize any significant
economic impact of the proposed rule
on small entities, such as
(a) The establishment of differing
compliance or reporting requirements or
timetables that take into account the
resources available to small entities;
(b) The clarification, consolidation, or
simplification of compliance and
reporting requirements under the rule
for such small entities;
(c) The use of performance rather than
design standards; and
(d) An exemption from coverage of
the rule, or any part thereof, for such
small entities.
The Regulatory Flexibility Act further
states that the required elements of the
IRFA may be performed in conjunction
with or as part of any other agenda or
analysis required by any other law if
such other analysis satisfies the relevant
provisions.
While a full understanding of OSHA’s
analysis and conclusions with respect to
costs and economic impacts on small
businesses requires a reading of the
complete PEA and its supporting
materials, this IRFA will summarize the
key aspects of OSHA’s analysis as they
affect small businesses.
1. A Description of the Impact of the
Proposed Rule on Small Entities.
The proposed regulation would
require classification of chemicals,
especially chemical mixtures, somewhat
different from current hazard
determination methods; a standardized
format for the organization of MSDSs
(now called SDSs); standardized labels
and standardized pictograms; and
training for affected employees on these
changes. (Some commenters argued that
GHS would also impose more stringent
testing requirements, but as explained
in Section V of the preamble, the HCS
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does not currently require testing of
chemicals, and will not require testing
with adoption of the GHS.)
For the purpose of its cost analysis,
OSHA estimated three types of cost:
(1) Costs to chemical producers of
classifying chemicals, reformatting
SDSs, and developing new labels;
(2) Costs for safety and health
managers and logistics personnel to
familiarize themselves with the
standard (although not required by the
regulation, this is a necessary step in its
implementation); and
(3) Costs of training affected
employees on how to find the
information they need on SDSs and to
comprehend pictograms and standard
labels.
OSHA believes that each of these is a
one-time cost that would be incurred
during the three-year transition period
after the final rule is published. OSHA
anticipates that, once the final rule is
implemented, the costs under GHS will
be equivalent to the costs under the
existing HCS system. In other words,
once chemical producers and
distributors set up for and shift to the
GHS system, OSHA expects there will
be no additional costs arising from the
proposed rule for classification, SDSs,
and labeling.
OSHA also anticipates that, after the
three-year transition period, the
familiarization costs for health and
safety managers, logistics personnel,
and emergency response planners and
the training costs for affected employees
will be lower under the uniform GHS
system than under the existing HCS
system. (However, in its estimates of
economic impacts, OSHA has not
included any cost savings for the
expected lower training costs.)
OSHA welcomes comments on these
points, which are critical to OSHA’s
economic analysis of costs, benefits, and
economic impacts.
OSHA’s criteria for determining
whether there are significant economic
impacts on a substantial number of
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small firms are that, for any given
industry, the annualized costs as a
percentage of revenues do not exceed 1
percent and that the annualized costs as
a percentage of profits do not exceed 5
percent. All of OSHA’s calculations of
the economic impacts on small firms
totally ignore any offsetting benefits of
any kind, even though OSHA estimates
that, for most small firms, the benefits
of this rule will actually exceed the
costs.
OSHA’s industry-by-industry
analysis, both for small firms as defined
by SBA and for very small firms with
fewer than 20 employees, shows that in
no industry size class do the annualized
costs exceed 0.013 percent of revenues
or 0.4 percent of profits. For affected
small firms as defined by SBA, the
average annualized cost per firm of the
proposed rule would be $16 per year. In
terms of chemical producing industries
only, the average annualized cost per
small firm as defined by SBA would be
$452 per year. For affected firms with
fewer than 20 employees, the average
annualized cost per firm of the proposed
rule would be $12 per year, and the
average annualized cost per firm that
produces chemicals would be $167 per
year.
Given these results, OSHA concludes
that the proposed rule will not have a
significant economic impact on a
substantial number of small firms. Thus,
an IRFA is not required for this
rulemaking. However, recognizing the
possible value that such an analysis may
provide, OSHA has voluntarily included
the elements of the IRFA as part of this
Initial Regulatory Flexibility Screening
Analysis (IRFSA) and has analyzed the
potential impact of the proposed
revisions on small entities. As described
in Section D of this economic analysis,
the proposed revisions to HCS, on the
whole, are expected to result in
significant net benefits to employers, as
the associated cost savings outweigh the
corresponding compliance costs. The
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underlying analysis included the effects
on small entities, and this conclusion
generally applies to the small entities
affected by the proposed rule.
In order to ensure that any potential
significant adverse impact on a
substantial number of small entities
would be appropriately considered,
OSHA also specifically evaluated the
impact on small entities of the costs of
compliance alone, without regard to the
associated savings.
The total annualized cost of
compliance with the proposal for small
entities is estimated to be approximately
$63 million, as shown by industry in
Table VII–6.
To assess the potential economic
impact of the proposal on small entities,
OSHA calculated the ratios of
compliance costs to profits and to
revenues. These ratios are presented for
each affected industry in Table VII–6.
OSHA expects that among small entities
potentially affected by the proposal, the
average increase in prices necessary to
completely offset the compliance costs
would be 0.0009 percent. The average
price increase necessary to completely
offset compliance costs would not
exceed 0.02 percent among small
entities in any single affected industry
sector.
In the event that no costs could be
passed through, the compliance costs
could be completely absorbed through
an average reduction in profits of less
than 0.02 percent. In most affected
industries the compliance costs could
be completely absorbed through an
average reduction in profits of less than
0.05 percent; the reduction would be no
more than 0.4 percent in any of the
affected industries.
To further evaluate the potential for
any adverse effects on small entities
resulting from the proposal, OSHA
assessed the short-term impacts that
may be associated with the compliance
costs during the transition period.
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The total non-annualized compliance
costs for small entities during the three-
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year transition period are estimated to
be $740 million, or about $247 million
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per year for three years. Thus, the
potential temporary impact would be
about 0.003 percent of revenues or about
0.1 percent of profits, on average, per
year for three years.
In order to further ensure that
potential impacts on small entities were
fully analyzed and considered, OSHA
also separately examined the potential
impacts of the proposed standard on
very small entities, defined as those
with fewer than 20 employees. As
shown in Table VII–7, the total
annualized costs for entities in this size
class would be an estimated $40
million. The annualized costs represent
about 0.001 percent of revenues and less
than 0.03 percent of profits. The total
non-annualized compliance costs for
very small entities during the three-year
transition period are estimated to be
$463 million, or about $154 million per
year for three years. Thus, the potential
temporary impact would be less than
0.005 percent of revenues or 0.15
percent of profits, on average, per year
for three years.
In order to more carefully focus on the
industry sectors most likely to have
significant economic impacts, OSHA
carefully examined those industries in
the chemical manufacturing and
petroleum and coal products
manufacturing sectors (‘‘chemical and
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petroleum producers’’) that produce
chemicals and SDSs. OSHA examined
the extent to which these firms might
have significant economic impacts if
they produced an unusually high
number of chemical products requiring
SDSs.
To examine this issue, OSHA
examined all small chemical and
petroleum producers with respect to
their costs as a percentage of revenues
and profits. Using the same cost
estimation methods as the base analysis,
OSHA estimated how many separate
chemical products a small firm would
have to produce for its annualized costs
of compliance with the proposed rule to
exceed 5 percent of profits. OSHA found
that the firm would have to produce
3,385 distinct chemical products, each
requiring its own SDS. OSHA thinks it
very unlikely that there are substantial
numbers of small firms (with an average
of 27 employees) that produce 3,385 or
more distinct chemical products.
Swedish data show that less than 0.1
percent of all firms (including large
firms) in Sweden produce more than
500 distinct chemical products.
(Swedish Chemical Agency, https://
www.kemi.se/templates/
Page____4268.aspx, 2007 data.)
OSHA conducted a similar analysis
for very small firms with fewer than
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twenty employees. This analysis found
that such firms, with an average of 4.7
employees, would need to produce
more than 140 distinct chemical
products for costs to exceed 5 percent of
profits. OSHA estimates that this would
be a very rare situation.
Further, even if small firms could be
found that produce more than 3,385
chemical products and very small firms
that produce more than 140 chemical
products, the costs would probably be
much lower than OSHA estimates. First,
firms producing this many distinct
products probably would not produce
SDSs and labels by hand, as OSHA
assumes most small firms do, but would
instead invest in appropriate software to
lower their costs, as most larger firms
do. Second, firms producing large
numbers of chemical products
commonly do so because they sell a
variety of different mixtures. Once
appropriate data for the ingredients of
these mixtures had been developed,
using the bridging principles outlined in
Appendix A of the preamble, small
firms developing SDSs and labels for
each mixture would take far less than
the 7 hours per chemical product that
OSHA has estimated for small firms to
convert to the GHS system.
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OSHA therefore concludes that there
are not a substantial number of firms
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that would incur significant economic
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impacts as a result of producing a very
large number of chemical products.
OSHA remains concerned with the
possible problems of small and very
small firms that might produce very
large numbers of distinct chemical
products. OSHA welcomes comments
on the issue of whether there are small
and very small firms that produce a very
large number of products, what
industries they are in, and their
anticipated costs to convert to the GHS
system.
2. A description of the reasons why
action by the agency is being
considered.
OSHA’s HCS was first adopted in
1983 for manufacturing (48 FR 53280).
Later the Agency expanded the scope of
coverage to include all industries where
employees are potentially exposed to
hazardous chemicals (52 FR 31852).
The HCS requires chemical
manufacturers and importers to evaluate
the hazards of the chemicals they
produce or import. The rule provides
definitions of health and physical
hazards to use as the criteria for
determining hazards in the evaluation
process. The information about the
hazards and protective measures is then
required to be conveyed to downstream
employers and employees by putting
labels on containers and preparing and
distributing safety data sheets. All
employers with hazardous chemicals in
their workplaces are required to have a
hazard communication program,
including container labels, safety data
sheets, and employee training.
Ensuring that this information is
available in workplaces helps employers
design and implement appropriate
controls for chemical exposures, and
gives employees the right-to-know and
the knowledge of the hazards and
identities of the chemicals, as well as
allowing them to participate actively in
the successful control of exposures.
Together, these actions of employers
and employees reduce the potential for
adverse effects to occur. The
information transmitted under the HCS
requirements provides the foundation
upon which a chemical safety and
health program is built in the
workplace. Without this information,
appropriate controls could not be
identified and implemented.
OSHA’s HCS is designed to
disseminate information on chemicals
to precipitate changes in handling
methods and thus protect those exposed
to the chemical from experiencing
adverse effects. To protect employees
and members of the public who are
potentially exposed to chemicals during
their production, transportation, use,
and disposal, a number of countries
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have developed laws that require
information about those chemicals to be
prepared and transmitted to affected
parties. These laws vary with regard to
the scope of chemicals covered,
definitions of hazards, the specificity of
requirements (e.g., specification of a
format for safety data sheets), and the
use of symbols and pictograms. The
inconsistencies between the various
laws are substantial enough that
different labels and safety data sheets
must often be used for the same product
when it is marketed in different nations.
For example, Canada has established
requirements for labels under its
Workplace Hazardous Materials
Information System (WHMIS). WHMIS
requires that labels include specified
symbols within a defined circle. U.S.
chemical manufacturers must label their
chemicals accordingly for marketing in
Canada.
Development of multiple sets of labels
and safety data sheets for each product
when shipped to different countries is a
major compliance burden for chemical
manufacturers, distributors, and
transporters involved in international
trade. Small businesses may have
particular difficulty in coping with the
complexities and costs involved, and it
has been argued that these differing
requirements may be a technical (nontariff) barrier to trade.
These concerns led, in June 1992, to
a mandate from the United Nations
Conference on Environment and
Development (UNCED) (Chapter 19 of
Agenda 21), supported by the U.S.,
calling for development of a globally
harmonized chemical classification and
labeling system. The negotiations were
extensive and spanned a number of
years. The product resulting from this
effort, the Globally Harmonized System
of Classification and Labeling of
Chemicals, was formally adopted by the
new United Nations Committee of
Experts on the Transport of Dangerous
Goods and the Globally Harmonized
System of Classification and Labeling of
Chemicals in December 2002.
The proposed modifications to the
HCS incorporate the GHS’s
requirements. They would require
chemical manufacturers to apply new
hazard classification criteria to their
chemicals and to prepare and distribute
new labels and safety data sheets.
Further, these SDSs and labels would be
standardized in a way that they are not
under the existing hazard
communication standard. OSHA’s
current performance-based approach to
SDSs and labeling can create confusion
among those who seek to use hazard
information effectively. For example,
labels and safety data sheets may
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include symbols and hazard statements
that are unfamiliar to readers or not well
understood. This lack of standardization
and the absence of pictograms are
particularly a problem for U.S. workers
not literate in English. Containers may
be labeled with such a large volume of
information that important statements
are not easily recognized.
OSHA believes that adoption of these
new requirements would benefit
employers and enhance employee
safety. Employers who use chemicals,
and exposed employees, would benefit
from receiving the revised labels and
safety data sheets prepared in a
consistent format. The information
should be easier to comprehend and
access in the new approach, allowing it
to be used more effectively for the
protection of employees. The primary
effect in workplaces where chemicals
are used but not produced would be to
integrate the new approach into the
workplace hazard communication
program, including assuring that both
employers and employees understand
the pictograms and other information
provided on the chemicals.
OSHA believes that adoption of the
GHS would improve labels and SDS
comprehensibility through
implementation of a standardized
approach. The current regulatory system
includes a performance-oriented
approach to labels and SDSs, allowing
the producers to use whatever language
or format they choose to provide the
necessary information. This results in a
lack of consistency that makes it
difficult for users of chemicals to
properly identify their hazards and
protective measures, particularly when
purchasing the same product from
multiple suppliers. Having the
information provided in the same words
and pictograms on labels, as well as
having a standardized order of
information on SDSs, would help all
users, including employers, employees,
and safety and health responders, more
easily identify the critical information
necessary to protect employees.
In addition, American employees and
employers should receive benefits from
the international adoption of GHS.
Development of the GHS system
required extensive work by a great
number of people, and resources from
many countries and organizations. The
reason it received such support is that
there is a belief that there are significant
benefits associated with implementation
of a globally harmonized approach to
hazard communication. Countries,
international organizations, chemical
producers, and users of chemicals
would all benefit. There are at least four
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reasons to expect that GHS will be
adopted globally.
First and foremost, implementation of
the GHS would enhance protection of
humans and the environment.
Occupationally related injuries,
illnesses, and fatalities remain a serious
problem in the U.S. For example,
although likely to contain very
significant underreporting, data from
the Bureau of Labor Statistics indicate
that, in 2007, employees suffered an
estimated 55,400 illnesses attributable
to chemical exposures (BLS, 2008), and
that some 17,340 chemical-source
injuries and illnesses involved days
away from work (BLS, 2009). As shown
in the preliminary economic analysis,
the adoption of the proposed revisions
is expected to result in a significant
reduction in injuries, illnesses, and
fatalities among U.S. employees
exposed to hazardous chemicals. In
addition, while some countries, such as
ours, already have the benefits of
protection under existing systems, the
majority of countries do not have such
comprehensive approaches. Thus,
implementation of the GHS would
provide these countries with the
important protections that result from
dissemination of information about
chemical hazards and protective
measures. In our country, we expect to
improve and build on protections we
already have.
Second, implementation of such an
approach would facilitate international
trade in chemicals. It would reduce the
burdens caused by having to comply
with differing requirements for the same
product, and allow companies who do
not have the resources to deal with
those burdens to be involved in
international trade.
Third, one of the initial reasons this
system was pursued internationally
involved concerns about animal welfare
and the proliferation of requirements for
animal testing and evaluation. Existing
systems with different definitions of
hazards often result in duplicative
testing to produce data related to the
varying cut-offs in the different systems.
Having one agreed definition would
reduce this duplicative testing. It should
be noted, however, that OSHA has never
had testing requirements. The HCS is
based on collecting and evaluating the
best available existing evidence on the
hazards of each chemical.
Fourth, information transmittal
systems provide the underlying
infrastructure for the sound
management of chemicals in a country.
Those countries that do not have the
resources to develop and maintain such
a system can use the GHS to build their
chemical safety and health programs.
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Since it has been developed, and will be
maintained, through an international
approach, national resources to
accomplish chemical safety and health
can be streamlined. Unlike some other
issues, a country’s approach to the
sound management of chemicals
definitely affects others countries. In
some cases, bordering countries may
experience pollution and other effects of
uncontrolled chemical exposures. In all
countries, there is a need to acquire
sufficient information to properly
handle the chemical when it is imported
from other countries. Thus having a
coordinated and harmonized approach
to the development and dissemination
of information about chemicals would
be mutually beneficial to importing and
exporting countries.
In the U.S., there are four primary
regulatory agencies that exercise
jurisdiction over chemical hazard
communication: OSHA; the Department
of Transportation, which regulates
chemicals in transport; the Consumer
Product Safety Commission, which
regulates consumer products; and the
Environmental Protection Agency,
which regulates pesticides and has other
labeling authority under the Toxic
Substances Control Act. These agencies
are not domestically harmonized in
terms of definitions of hazards and other
requirements. If all four agencies adopt
the GHS, the U.S. would have the
additional benefit of harmonizing the
overall U.S. approach to classification
and labeling. Since most chemicals are
produced in a workplace and shipped
elsewhere, nearly every employer deals
with at least two sets of Federal
requirements. Thus every producer
would be likely to experience some
benefits from domestic harmonization.
OSHA has made a preliminary
determination that the proposed
revisions would improve the quality
and consistency of information
provided to employers and employees
regarding chemical hazards and
associated protective measures. The
Agency anticipates this improved
information would enhance the
effectiveness of the HCS in ensuring that
employees are apprised of the chemical
hazards to which they are exposed, and
in reducing the incidence of chemicalrelated occupational illnesses and
injuries. OSHA preliminarily estimates
that (1) savings in benefits from
improved employee health and safety
exceed the costs of the proposed rule,
and (2) cost savings to chemical users
exceed the costs of the proposed rule.
An additional and more complete
discussion of the reasons why this
standard is being proposed by the
Agency is provided in other parts of the
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preamble section of this Notice of
Proposed Rulemaking (NPRM).
3. Statement of the objectives of, and
legal basis for, the proposed rule.
The primary objective of the proposed
revisions to the OSHA HCS is to achieve
the potential benefits of the OSHA HCS
in a more comprehensive, efficient, and
effective manner. The revisions are
expected to provide an increased degree
of occupational safety and health for
employees exposed to hazardous
chemicals in the workplace.
Another objective of the proposed
revisions is to provide updated, clear,
and comprehensive standards regarding
the classification of chemical hazards
and the manner in which relevant
information about chemical hazards is
disseminated to affected employees.
The intent of the HCS is to ensure that
the hazards of all chemicals are
evaluated and that information
concerning chemical hazards and
associated protective measures is
transmitted to employers and
employees. The standard achieves this
goal by requiring chemical
manufacturers and importers to review
available scientific evidence concerning
the physical and health effects of the
chemicals they produce or import to
determine if they are hazardous.
For every chemical found to be
hazardous, the chemical manufacturer
or importer must develop a container
label and an SDS and provide both to
downstream users of the chemical. All
employers with employees exposed to
hazardous chemicals must develop a
hazard communication program and
ensure that exposed employees are
provided with labels, access to SDSs,
and training on the hazardous chemicals
in their workplace.
The three information components in
this system—labels, SDSs, and
employee training—are all essential to
the effective functioning of the program.
Labels provide a brief, conspicuous
summary of hazard information at the
site where the chemical is used. 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. Training is designed to ensure
that employees understand the chemical
hazards in their workplace and are
aware of protective measures to follow.
Labels, SDSs, and training are
complementary parts of a
comprehensive hazard communication
program—each element reinforces the
knowledge necessary for effective
protection of employees.
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Information provided in accordance
with the HCS serves to reduce the
incidence of chemical-related illnesses
and injuries in the workplace. This is
accomplished by modifying the
behavior of both employers and
employees. Providing information to
employers enables them to implement
protective measures in the workplace.
Less hazardous alternatives may be
chosen, or appropriate engineering
controls, work practices, and personal
protective equipment can be selected.
Improved understanding of chemical
hazards by supervisory personnel
results in safer handling of hazardous
substances, as well as proper storage
and housekeeping measures.
Employees provided with information
and training on chemical hazards are
able to fully participate in the protective
measures instituted in their workplaces.
Knowledgeable employees can take the
steps required to work safely with
chemicals in their workplace and are
able to determine what actions are
necessary if an emergency occurs.
Information on chronic effects of
exposure to hazardous chemicals helps
employees recognize signs and
symptoms of chronic disease and seek
early treatment. Information provided
under the HCS also enables health and
safety professionals to provide better
services to exposed employees. Medical
surveillance, exposure monitoring, and
other services are enhanced by the ready
availability of health and safety
information.
OSHA believes that the
comprehensive approach adopted in the
HCS, which includes requiring
evaluation of chemicals and the
transmittal of information through
labels, SDSs, and training, is sound.
This proposed rule does not alter that
approach. Rather, the proposed rule is
intended to improve the effectiveness of
the HCS by enhancing the quality and
consistency of the information provided
to employers and employees. OSHA
believes this can be accomplished by
revising the requirements of the
standard to conform to the more specific
and detailed provisions of the GHS for
classification, labeling, and SDSs.
The legal basis for the rule is the
responsibility given the Department of
Labor through the Occupational Safety
and Health (OSH) Act of 1970. The OSH
Act authorizes and obligates the
Secretary of Labor to promulgate
mandatory occupational safety and
health standards as necessary ‘‘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). The OSH Act gives the
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Agency authority to issue and revise
standards and regulations to further this
goal. A thorough discussion of the legal
basis can be found in the preamble to
the proposed standard in Section VI—
Pertinent Legal Authority.
4. Description of and estimate of the
number of small entities to which the
proposed rule will apply.
OSHA has completed a preliminary
analysis of the impacts associated with
this proposal, including an analysis of
the type and number of small entities to
which the proposed rule would apply,
as described above. In order to
determine the number of small entities
potentially affected by this rulemaking,
OSHA used the definitions of small
entities developed by the Small
Business Administration (SBA) for each
industry.
The proposed standard would impact
firms that are the primary producers or
distributors of hazardous chemicals, and
firms whose employees are exposed to
hazardous chemicals. Based on the
definitions of small entities developed
by SBA for each industry, the proposal
is estimated to potentially affect a total
of 4,215,404 small entities, as shown in
Table VII–6. The rule would have its
greatest impacts on the 72,000 small
firms that produce chemicals that
require SDSs and labels.
5. Description of the projected
reporting, recordkeeping and other
compliance requirements of the
proposed rule.
The proposed standard includes
revised criteria for classification of
chemical hazards; revised labeling
provisions that include requirements for
use of standardized signal words,
pictograms, and hazard statements; a
specified format for safety data sheets;
and related revisions to definitions of
terms used in the standard, employee
information and training requirements,
and other sections of HCS.
The preamble to the proposed
standard provides a comprehensive
description of, and further detail
regarding, the compliance requirements
of the proposed rulemaking. A
description of the types of entities
which would be subject to the new and
revised requirements, and the types of
professional skills necessary for
compliance with the requirements, is
presented in the relevant sections of this
economic analysis and the
corresponding supporting research, and
is summarized below with a summary of
unit costs. Except for employee training,
these costs would apply only to those
businesses not already in compliance
with the proposed revisions. OSHA
requests comments and information
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from the public regarding these
estimates:
Reclassifying chemicals and
modifying SDSs and labels:
• Medium establishments (100–499
employees): an average of 5 hours per
SDS; in addition, for 25 percent of
establishments, an average of $200 per
SDS for software modifications.
• Small establishments (1–99
employees): an average of 7 hours per
SDS.
Management familiarization and
other costs:
• Eight hours for health and safety
managers and logistics personnel in the
manufacturing sector.
• Two hours for each hazard
communication program manager not in
the manufacturing sector.
Employee training:
• 30 minutes per production
employee in most industries;
• 15 minutes in occupations exposed
to few hazardous chemicals and types of
hazards;
• 5 minutes per employee in some
occupations where GHS-type
pictograms are already in use.
6. Federal rules which may duplicate,
overlap or conflict with the proposed
rule.
OSHA has not identified any other
Federal rules which may duplicate,
overlap, or conflict with the proposal,
and requests comments from the public
regarding this issue.
7. Alternatives to the proposed rule
which accomplish the stated objectives
of applicable statutes and which
minimize any significant economic
impact of the proposed rule on small
entities.
As discussed in Section IV, this
rulemaking is unique for OSHA in that
it seeks to improve employee
protections by adopting an
internationally harmonized approach to
hazard communication issues. While
the current HCS has provided
protections for exposed workers by
disseminating information about
chemicals in their workplaces for many
years now, the approach taken in the
GHS strengthens and refines the system,
and gives OSHA the opportunity to
improve hazard communication by
adopting it. The GHS has the same
general concept of an integrated,
comprehensive process of identifying
and communicating hazards, but
provides more extensive criteria to
define the hazards in a consistent
manner, as well as standardizes label
elements and SDS formats to help to
ensure that the information is conveyed
consistently.
OSHA has preliminarily concluded
that required adoption of GHS is the
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best approach to modifying the HCS to
achieve the goals of global
harmonization, ease of use, and
improved health and safety. As
addressed in Section XV of the
preamble, many commenters supported
the concept of OSHA moving forward to
adopt the GHS. Several objected to
adoption, and OSHA has identified and
responded to their concerns in Section
XV of the preamble as well. In addition,
there were several commenters who
noted that small chemical
manufacturers that are not engaged in
international trade of chemicals would
have a large burden associated with
adopting the GHS, and questionable
benefits due to their lack of involvement
in international trade. The Small
Business Administration (SBA)
suggested that OSHA ‘‘consider
‘grandfathering’ or exempting small
businesses that do not export regulated
chemicals.’’ (Document ID # 0022)
Others simply noted that they believed
there would be high costs and limited
benefits for such employers, or that it
would be costly and difficult to adopt
(Document ID #s 0015, 0026, 0178, and
0144). There was no discussion in any
of these comments about how this might
work in the revised standard.
None of these commenters suggested
a detailed approach to exactly how such
a grandfathering or exemptions might
work. OSHA welcomes comments on
how such approaches might work.
A somewhat different alternative that
might achieve the goals of those
employers who anticipate high costs for
little benefit to themselves would be for
OSHA to consider simply facilitating
the voluntary adoption of GHS. With
some very minor exceptions that could
easily be changed by rule, the existing
HCS performance-based approach to
MSDS would permit chemical
producers and importers to use the
proposed GHS SDS format and
approach. They could not however,
adopt the GHS classifications without a
change to the rule allowing the use of
GHS classifications where they differed
from those in HCS. The use of labels
adopting GHS signal words,
precautionary statements, formats, and
pictograms could be possible under the
HCS performance-based approach to
labels. However, it should be carefully
noted that, although the resulting label
might appear GHS compliant, it need
not actually be GHS-compliant, and in
some case would not be based on the
GHS classifications. Further, individual
firms could produce labels using GHS
formats, etc., with meanings quite
different from those in GHS.
The advantages of a system that
simply facilitated voluntary adoption of
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GHS are that (1) those engaged in
international trade, whether as exporters
or importers, could obtain the full
benefits of international harmonization;
(2) those producers of chemicals who
saw no market advantage to changing
systems would not need to incur the
costs associated with changing their
hazard classification, MSDSs, and labels
and (3) it is possible that employee
training under a performance-based
system for MSDSs and labels would not
need to be required or changed.
OSHA sees a number of disadvantages
to a rule that simply facilitates the
voluntary adoption of GHS. First
consider the issues of a common MSDS/
SDS format versus MSDS/SDS formats
that can vary in any way whatsoever
while meeting a standard of what an
MSDS must contain. Such an approach
would eliminate a proportion of the
possible benefits from knowing where to
look in an SDS for the information one
wants or needs, since many SDSs will
still not be standardized.
From OSHA’s perspective, a key issue
of concern in such an approach is that
the classification criteria in the GHS are
different from the hazard definitions in
the current HCS. In general, as
discussed in Section XV of the
preamble, they cover the same scope of
hazard, so these differences do not
result in significant differences in the
chemicals covered. But the GHS criteria
divide most of the hazard classes into
hazard categories that convey the
severity of the effect, while few of the
hazard definitions in the current HCS
take this approach. The standardized
label elements are associated with these
specific hazard categories, i.e., the
harmonized pictograms, signal words,
and hazard statements are assigned by
hazard category and reflect the degree of
hazard it presents to those exposed.
Likewise, the precautionary statements
assigned are also reflective of the degree
of hazard, with responses related to
these presumed hazard levels.
Third, consider the possible
disadvantages of not having a common,
well-understood labeling system with
signal words, pictograms, precautionary
statements and common formatting. In
the absence of such a system it would
be extremely difficult to teach persons
not literate in English how to
understand labels, and even those
literate in English may have difficulty
with major differences in the symbols
and language used for the same
substance or hazard.
It should also be noted that allowing
the voluntary use of GHS might not be
considered GHS-compliant as the
phrase is used in GHS publications.
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It is difficult to quantify the benefits
and costs of the alternative of simply
facilitating adoption of GHS. Part of the
problem is that it is difficult to forecast
the extent to which persons would
voluntarily adopt GHS. OSHA therefore
considered two scenarios. In the first
scenario, there is no extensive adoption
of GHS and GHS becomes simply a
minor sub-class of the performanceoriented options already available. This
scenario has the effect of minimizing the
costs associated with the facilitation of
voluntary adoption of GHS, but at the
expense of minimizing the benefits of
this alternative. In the second scenario,
GHS would be adopted widely enough
to become the norm for hazard
communication, but some would
continue their existing HCS approaches
unchanged. Under this scenario, most
firms would insist that their health and
safety managers and logistics personnel
be thoroughly familiar with GHS, and
that employees be trained on GHS. This
scenario minimizes the loss in benefits
associated with the first scenario, but
involves much greater costs than
scenario 1 and may involve significantly
increased costs over the option of full
compliance with GHS. OSHA believes
that the actual results will fall between
these two scenarios and is seeking
comment on the relative likelihood of
these or other scenarios.
OSHA suspects that second scenario
might be the more likely possibility. For
example, the standardized MSDS
system adopted by GHS is widely used
in the U.S., particularly by large firms
and firms with many MSDSs, though
many have not adopted this system.
Domestic and international producers,
and large and small producers are not
mutually exclusive—a large business
engaged in international trade can not
simply implement the GHS regardless of
its suppliers. Small businesses sell to
large businesses. If small businesses do
not adopt the GHS, then the large
businesses would have to generate GHS
classifications for chemicals they buy
from them in order to follow the GHS.
It would be difficult for them to do this,
particularly for mixtures, since they are
not the producer of the chemicals. This
concept was addressed in comments
regarding the effective dates for the rule,
when many suggested it was not
appropriate to differentiate dates based
on the size of the business. For example,
ORC Worldwide, Inc. stated (Document
ID # 0123):
OSHA should consider a company’s place
in the manufacturing supply chain, not size,
in determining how the phase-in is
implemented. It would be sensible to start
with producers of raw materials and basic
chemicals. The technical information,
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classification and categorization they perform
will be useful downstream for the
intermediate chemical producers and
specialty chemical manufacturers. Lastly, the
end user will benefit from the influx of
information developed by the upstream
professionals.
Just as the size of the company may not
be an appropriate criterion to determine
when that company should be in
compliance, it also does not appear to
be a useful way to determine whether
the GHS provisions should be adopted
by them. It is difficult to determine how
a voluntary system, or a system based
on business size, would be successfully
implemented and enforced given the
structure of the supply system. Because
of these factors, OSHA anticipates that
many smaller firms who may think they
do not need GHS may be forced through
the market to adopt the system to satisfy
the needs of customers who do engage
in international trade.
Under the first scenario, with no
extensive voluntary adoption of GHS,
the annualized costs $11 million per
year for reclassification of chemicals
and the $44 million in annualized costs
for one-time retraining of workers
would be largely eliminated. OSHA
estimates that the $45 million in
annualized costs for health and safety
managers and logistics personnel to
familiarize themselves with the GHS
system would still be incurred. This
alternative might add a continuing cost
not present under either system of the
need for new health and safety
managers and logistics personnel to be
familiar with both systems. Assuming a
5 percent annual turnover among such
professional, assuring continuing
knowledge of both systems would add
costs of $25 million per year. This
alternative under Scenario 1 would thus
reduce the costs from $97 million per
year to between $42 million per year
and $77 million per year depending on
whether it is assumed that new health
and safety managers and logistics
personnel would need to be familiar
with both systems. In return for this
reduction in costs, under Scenario 1,
because of the assumption of no
significant adoption of GHS, the benefits
of $851 million per year are also lost.
Furthermore, this analysis ignores nonquantified benefits of full adoption of
GHS, such as decreases in training costs
associated a full GHS system.
In choosing the voluntary adoption of
GHS alternative, OSHA would be
ignoring the potentially substantial
health and safety benefits arising from
the economically feasible (and, for most
businesses, the economically desirable)
option of full compliance with GHS and
instead adopting a system with no such
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health and safety benefits for the sole
reason of possibly saving a small
minority of all affected businesses some
costs.
Under Scenario 2, with widespread
voluntary adoption of GHS, more
benefits would be achieved than under
Scenario 1, but all the benefits available
under the proposed rule would not be
achieved, and OSHA believes there
would be greater costs than under the
option of requiring full compliance with
GHS. However, if widespread adoption
of GHS is to result in substantially
higher benefits than under Scenario 1,
then health and safety managers and
logistic personnel would have to be
fully familiar with both systems, and
employees would also need to be
trained on GHS as the primary system
and not just as one of many
performance-oriented options. Thus,
Scenario 2 would save some portion of
the $11 million in annualized costs per
year spent by chemical producers for
reclassification and modifying SDSs and
labels. However, the full costs of
management familiarization and onetime employee training would still need
to be incurred. In addition continuing
costs would have to be incurred for new
health and safety managers and logistic
personnel to familiarize themselves
with two systems and for new
employees to be trained on both
systems. Assuming turnover of 5
percent for manager and 20 percent for
employees, the associated annual costs
would be $150 million per year. Under
Scenario 2, the alternative of facilitating
voluntary adoption would achieve some
portion of the benefits of GHS but with
significantly greater costs—an
additional $150 million per year for
continuing GHS training of new
employees and GHS familiarization for
new health and safety managers and
logistics personnel, offset by a very
modest reduction in costs to chemical
producers.
In terms of benefits, both OSHA’s
proposed full GHS compliant approach
and that of a dual system would retain
possible benefits to chemical producers
and to international trade. However,
OSHA is concerned that the confusions
arising might negate some of the
benefits associated with reduced
injuries, illnesses and fatalities. While
there would still be some situations
where use of GHS would prevent
injuries, there would also be situations
where confusion and misunderstanding
would lead to injuries, illnesses, and
fatalities that might not otherwise be
incurred. For example, employees used
to seeing pictograms might easily make
the false assumption that chemicals
without a pictogram are safe. This has
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the potential to eliminate a significant
portion of the annual health and safety
benefits. Other benefits would also need
to be reduced, though it is not clear by
how much.
In addition to the chosen alternative
of full compliance with GHS, OSHA
also considered options requiring full
compliance with some but not all
portions of GHS. One such option
would be to adopt the provisions of the
GHS that are presumed to provide the
greatest benefits at the least cost. For
example, OSHA could adopt the
standardized label provisions without
the associated hazard classification
criteria. Employers would be free to
continue to use the existing hazard
determination scheme, but present the
label information in the standardized
form anticipated under the GHS. Since
the standardized labels appear to be
relatively inexpensive to implement,
while reviewing classifications is more
costly, this has the potential to reduce
the overall cost of implementation of the
revised rule.
This option—adopting the label
provisions but not the classification
criteria—presents many of the same
concerns. First, the reason the label
provisions are relatively cost-efficient to
adopt is that the GHS assigns the
various required elements by hazard
class and category. It is basically a
cookbook approach. Once the
classification or re-classification has
been accomplished, the GHS provides
the specific information for the label.
Requiring this standardized approach
to labeling without the infrastructure of
the criteria would be more burdensome
for the chemical manufacturer to
accomplish, though OSHA could
consider whether it would be
appropriate to provide criteria for HCS
classification under this alternative that
would reduce burden. However, OSHA
is also concerned that this alternative
would result in labels that may look the
same but which actually do not have
consistent warnings based on the
precise hazardous effect. Without the
GHS criteria that breaks hazard classes
into multiple categories for most effects,
it would be difficult to relate the label
elements to the hazard determinations
under the current HCS. For example, the
current standard treats all carcinogens
the same way, rather than differentiating
them into several categories. OSHA
would either have to provide some type
of decision logic to employers in order
to have a consistent approach or allow
the responsible party to determine the
appropriate labeling elements that
should be included on the label. The
most protective approach would be to
treat all carcinogens or other effects as
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being in the most hazardous category of
each class so there will be no choice of
label elements that would cause
differences among employers.
Regardless, chemical producers will
have to undergo an assessment of their
current determinations and attempt to
relate them to the established hazard
categories. This will be difficult,
particularly for small producers.
Alternatively, OSHA could create a
regulatory system assigning HCS
categories to each GHS label, but this
would be totally contrary to the
performance-orientation of the current
HCS system, as well as having
undetermined costs. It is thus unlikely
that this would provide significant
savings relative to simply reviewing
classifications for purposes of putting
the chemicals into GHS classes and
categories.
However, apart from this burden, the
benefits of standardized labeling would
be reduced by not having common
criteria upon which they are based.
Chemical producers following this
approach would likely not be able to use
their labels in other countries where the
GHS has been adopted. Hence, there
would be costs of adoption without
commensurate benefits in either
comprehensibility or facilitation of
trade.
Another type of dual approach would
have OSHA adopt some, but not all, of
the label elements. In particular, the
Agency might not adopt the exact
language of the precautionary
statements since this language has been
codified but are not yet considered to be
‘‘harmonized’’ under the GHS—they are
provided for guidance and reference,
but competent authorities may choose to
implement other statements. The exact
language for precautionary statements
could be adopted later when they are
harmonized under the GHS.
Alternatively, OSHA could either allow
label preparers to use whatever
precautionary statements they deem
appropriate or develop its own set of
statements to require.
The precautionary statements,
however, are the part of the GHS label
that provides the measures to follow to
ameliorate the possible hazardous
effects of exposure. Delaying adoption
of the precautionary statements would
likely reduce the effectiveness of the
labels significantly, and reduce the
appropriate information on the SDSs as
well. Labels that lack a precautionary
statement would not be fully
harmonized. The second alternative, to
simply require precautionary
statements, but not to specify what they
are, would provide some protection but
would not correct the current situation
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of inconsistent precautions due to the
performance-oriented approach that
allows the label preparer to determine
what they are or if they are included.
One communication advantage of
providing the information in the same
language from label-to-label is that
workers and other users can be assured
that the same action is required. If you
take a simple preventive measure such
as ‘‘wash your hands,’’ but convey it in
several different ways, the reader of the
label could think you mean something
different. This is one of the advantages
of providing the text for these
statements in the revised HCS.
It should be noted that it appears that
all of the commenters favoring an
alternative of less than full compliance
with GHS saw the primary benefits of
adopting the GHS would be in
facilitating international trade. As has
been addressed throughout the PEA,
however, OSHA has based the benefits
of this action on improved
communication to workers and to health
and safety managers and logistics
personnel resulting in improved safe
handling of hazardous chemicals, not on
the trade benefits which, while
recognized, have not been quantified.
Therefore, OSHA believes that any
grandfathering or exemption related to
this rule would result in some of these
parties not obtaining the same level of
benefits of increased comprehensibility
as workers in other types and sizes of
workplaces.
OSHA welcomes comments on these
issues, but in the absence of a clear case
for one of the alternatives presented,
OSHA will continue to consider the
alternative proposed, full compliance
with GHS by all U.S. firms, the best
alternative.
OSHA considered one other set of
alternatives to the proposed rule:
changing the proposed three-year
duration of the phase-in. A shorter
phase-in period was criticized by all
commenters both because of feasibility
issues and for radically increasing
compliance costs. OSHA did examine
the costs and benefits of a longer phasein, over a five-year period, and found
that the longer phase-in would lower
annualized costs from $97 million to
$88 million per year, but would also
lower the annualize benefits from $851
million per year to $693 million per
year, with the ultimate effect of
lowering net benefits. Even the lowering
of costs may be somewhat illusory
because these estimates do not take
account of the additional confusion
caused by having two different systems
in place for an additional two years.
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I. Environmental Impacts
The provisions of this proposal have
been reviewed in accordance with the
requirements of the National
Environmental Policy Act (NEPA) of
1969 (42 U.S.C. 4321, et seq.), the
Council on Environmental Quality
(CEQ) NEPA regulations (40 CFR parts
1500–1508), and the DOL NEPA
Procedures (29 CFR part 11). As a result
of this review, OSHA has determined
that the proposed standards would have
no significant adverse effect on air,
water, or soil quality, plant or animal
life, use of land, or other aspects of the
environment. OSHA anticipates that the
more complete and easier-to-understand
SDSs resulting from this proposal
would, in addition to increasing
employee health and safety, have
positive effects on the environment.
J. Unfunded Mandates Reform Act
Analysis
Section 3 of the Occupational Safety
and Health Act makes clear that OSHA
cannot enforce compliance with its
regulations or standards on the U.S.
government ‘‘or any State or political
subdivision of a State.’’ Under voluntary
agreement with OSHA, some States
enforce compliance with their State
standards on public sector entities, and
these agreements specify that these State
standards must be equivalent to OSHA
standards. Thus, although OSHA may
include compliance costs for affected
public sector entities in its analysis of
the expected impacts associated with a
proposal, the proposal would not
involve any unfunded mandates being
imposed on any State or local
government entity.
Based on the analysis presented in
this preliminary economic analysis,
OSHA concludes that the proposal
would impose a Federal mandate on the
private sector in excess of $100 million
in expenditures in any one year.
Accordingly, this preliminary economic
analysis of the proposed revisions to the
HCS constitutes the written statement
containing a qualitative and quantitative
assessment of the anticipated costs and
benefits of the Federal mandate, as
required under Section 202(a) of the
Unfunded Mandates Reform Act of 1995
(2 U.S.C. 1532(a)).
K. Sensitivity Analysis
The methodology and calculations
underlying the estimation of the
compliance costs, benefits, and
economic impacts 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
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to variations in the relevant input
parameters.
For example, if the estimated time
that companies need to reclassify
chemical hazards and revise SDSs and
labels were doubled, the corresponding
labor costs (but not software costs) of
reclassification and revision of SDSs
and labels 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 economic analysis
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held up. On the whole, OSHA found
that the conclusions of the analysis are
reasonably robust, as changes in any of
the input parameters tend not to
produce disproportionately large
changes in the results. The results also
show significant net benefits for the
proposed rule regardless of the
individual revisions to costs, benefits, or
discount rate. The results of the
individual sensitivity tests are
summarized in Table VII–8 and are
described in more detail below.
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In the sensitivity test where OSHA
doubled the estimated time that
companies need to reclassify chemical
hazards and revise SDSs and labels, and
estimates of other input parameters
remained unchanged, as shown in Table
VII–8, the estimated total costs of
compliance would increase by $8
million annually, or by about 8 percent,
while net benefits would also decline by
$8 million, from $754 million to $746
million annually.
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In a second sensitivity test, when
OSHA increased the estimated total
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number of affected SDSs addressed by
this rulemaking by 50 percent, the
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corresponding estimated total cost of
reclassification and revision of SDSs
and labels increased by 50 percent as
well. As shown in Table VII–8, if
OSHA’s estimates of other input
parameters remained unchanged, the
total estimated costs of compliance
would increase by $5.5 million
annually, or by about 6 percent, while
net benefits would also decline by $5.5
million annually, from $754 million to
$748 million annually.17
In a third sensitivity test, when OSHA
increased by 50 percent the estimated
number of employees required to be
covered by hazard communication
programs and to be trained on GHS, the
corresponding estimate of the total costs
associated with training employees
increased by 50 percent. As shown in
Table VII–8, if OSHA’s estimates of
other input parameters remained
unchanged, the total estimated costs of
compliance would increase by $22
million annually, or by about 23
percent, while net benefits would also
decline by $22 million annually, from
$754 million to $732 million annually.
In a fourth sensitivity test, when
OSHA doubled the estimated
incremental amount of time necessary
for training employees on GHS, the
corresponding estimate of the total costs
associated with training employees also
doubled. As shown in Table VII–8, if
OSHA’s estimates of other input
parameters remained unchanged, the
total estimated costs of compliance
would increase by $44 million annually,
or by about 45 percent, while net
benefits would also decline by $44
million annually, from $754 million to
$710 million annually.
OSHA also performed sensitivity tests
on several input parameters used to
estimate the benefits of the proposed
rule. In one sensitivity test on benefits,
OSHA reduced its estimate of health
and safety benefits of the proposed rule
from 1 percent to 0.5 percent of the
benefits estimated for the existing HCS.
As shown in Table VII–8, if OSHA’s
estimates of other input parameters
remained unchanged, the total
estimated benefits of the proposed rule
would decline by $133 million
annually, or by about 16 percent, while
net benefits would also decline by $133
million annually, from $754 million to
$610 million annually.
17 For this sensitivity analysis, OSHA calculated
only the impact on costs of an increase in the
number of SDSs. However, in principle, each
additional SDS would yield future benefits due to
improved efficiencies in creating and revising SDSs
under GHS. Although not shown in Table VII–8,
this effect would increase benefits by $8 million
annually, more than offsetting the $5.5 million
annual cost increase.
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In a second, parallel sensitivity test on
benefits, OSHA increased its estimate of
health and safety benefits of the
proposed rule from 1 percent to 5
percent of the benefits estimated for the
existing HCS. As shown in Table VII–8,
if OSHA’s estimates of other input
parameters remained unchanged, the
total estimated benefits of the proposed
rule would increase by $1,064 million
annually, or by about 125 percent, while
net benefits would also increase by
$1,064 million annually, from $754
million to $1,818 million annually.
In a third sensitivity test on benefits,
OSHA reduced its estimate of savings
due to the improved efficiency in
creating and revising SDSs under GHS
by 50 percent. As shown in Table VII–
8, if OSHA’s estimates of other input
parameters remained unchanged, the
total estimated benefits of the proposed
rule would decline by $8 million
annually, or by about 1 percent, while
net benefits would also decrease by $8
million annually, from $754 million to
$746 million annually.
In a fourth sensitivity test on benefits,
OSHA reduced its estimate of savings
due to the improved efficiency of safety
and health managers and logistics
personnel by 67 percent. As shown in
Table VII–8, if OSHA’s estimates of
other input parameters remained
unchanged, the total estimated benefits
of the proposed rule would decline by
$313 million annually, or by about 37
percent, while net benefits would also
decrease by $313 million annually, from
$754 million to $441 million annually.
OSHA also examined the effect of a
change in the discount rate on the
annualized costs and benefits. Changing
the discount rate from 7 percent, used
in the base case, to 3 percent would
have the effect of lowering the costs to
$73 million per year and increasing the
benefits to $916 million per year. The
result, as shown in Table VII–8, would
be to increase net benefits by $89
million per year, from $754 million to
$843 million per year.
OSHA also considered the sensitivity
of its findings that the proposed rule is
economically feasible and does not have
a significant economic impact on a
substantial number of small entities.
Since the estimated potential negative
impacts of the rulemaking are relatively
small, these impacts would remain
small even with relatively large changes
in the input parameters. For example,
even if the total estimated costs of
compliance were increased by a factor
of five, these costs would still represent
less than 0.002 percent of revenues, and
no industry or size class would have
costs in excess of 5 percent of profits or
1 percent of revenues.
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In conclusion, the sensitivity analysis
demonstrates that even with relatively
large variations in the input parameters,
there would not be any
disproportionately large changes in the
estimates of compliance cost or benefits.
Further, even if there were relatively
large uncertainties in the estimates of
compliance costs and benefits, there
would still be a relatively high
confidence in OSHA’s finding
concerning economic feasibility, the
certification that the standard will not
have significant economic impacts on a
substantial number of small firms, and
the conclusion that the benefits exceed
the costs.
OSHA welcomes input from the
public regarding all aspects of this
sensitivity analysis, including any data
or information regarding the accuracy of
the preliminary estimates of compliance
costs and benefit and how the estimates
of costs, benefits, and economic impacts
may be affected by varying assumptions
and methodological approaches.
VIII. OMB Review Under the
Paperwork Reduction Act of 1995
The proposed modifications to the
Hazard Communication Standard would
revise existing Hazard Communication
collection of information (paperwork)
requirements that are currently
approved by the Office of Management
and Budget (‘‘OMB’’) under the
Paperwork Reduction Act of 1995
(‘‘PRA–95’’), 44 U.S.C. 3501 et seq., and
OMB’s regulations at 5 CFR part 1320.
The Paperwork Reduction Act defines
‘‘collection of information’’ as ‘‘the
obtaining, causing to be obtained,
soliciting, or requiring the disclosure to
third parties or the public of facts or
opinions by or for an agency regardless
of form or format.’’ (44 U.S.C.
3502(3)(A).) OSHA has submitted the
proposed revised Hazard
Communication collection of
information requirements identified in
this NPRM to the OMB for review in
accordance with 44 U.S.C. 3507(d).
As part of its continuing effort to
reduce paperwork and respondent
burden, the Department of Labor
conducts a preclearance consultation
program to provide the general public
and Federal agencies with an
opportunity to comment on proposed
and continuing collections of
information in accordance with the
PRA–95 (44 U.S.C. 3506(c)(2)(A)). This
program ensures that information is in
the desired format, reporting burden
(time and costs) is minimal, collections
instruments are clearly understood, and
OSHA’s estimate of burden is accurate.
The Department notes that a Federal
agency cannot conduct or sponsor a
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collection of information unless it is
approved by OMB under the PRA, and
displays a currently valid OMB control
number, and the public is not required
to respond to a collection of information
unless it displays a currently valid OMB
control number. Also, notwithstanding
any other provisions of law, no person
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. OSHA will publish a notice of
OMB’s action at the final rule stage.
OSHA solicits comments on the
modified collection of information
requirements and the estimated burden
hours associated with these collections,
including comments on the following:
Æ Whether the proposed collection of
information requirements are necessary
for the proper performance of the
Agency’s functions, including whether
the information is useful;
Æ The accuracy of OSHA’s estimate of
the burden (time and cost) of the
information collection requirements,
including the validity of the
methodology and assumptions used;
Æ The quality, utility, and clarity of
the information collected; and
Æ Ways to minimize the burden on
employers who must comply, for
example, by using automated or other
technological techniques for collecting
and transmitting information.
The title, description of the need for
and proposed use of the information,
description of the respondents, and
frequency of response of the information
collections are described below, along
with an estimate of the annual reporting
burden and cost as required by 5 CFR
1320.5(a)(1)(iv) and 1320.8(d)(2).
Title: Proposed Changes to the Hazard
Communications Standard (Globally
Harmonized System of Classification
and Labeling of Chemicals (GHS)).
Description and Proposed Use of the
Collections of Information: The
proposed Standard would modify
existing information collection
requirements that are currently
approved under OMB Control Number
1218–0072 (Expiration Date: October
2009). OSHA has submitted the
proposed modification of the Hazard
Communication Standard to OMB and
has requested a new OMB control
number addressing the proposed
modification. OSHA will maintain OMB
approval of the existing collections of
information contained in the Hazard
Communication Standard, under OMB
Control Number 1218–0072.
The proposed revisions to the OSHA
Hazard Communication Standard would
standardize the hazard communication
requirements for products used in U.S.
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workplaces, and thus provide
employees with consistent hazard
communication information. Hazard
communication is currently addressed
by many different international,
national, and State authorities. These
existing requirements are not always
consistent and often contain different
definitions of hazards and varying
provisions for what information is
required on labels and safety data
sheets. The proposed revisions would
harmonize the U.S. system with
international norms and therefore
would facilitate international trade. The
proposed modifications to the
Standard’s collection of information
requirements include: (1) Revised
criteria for classification of chemical
hazards; (2) revised labeling provisions
that include requirements for use of
standardized signal words, pictograms,
hazard statements, and precautionary
statements; (3) a specified format for
safety data sheets; and (4) related
revisions to definitions of terms used in
the Standard and to requirements for
employee training on labels and safety
data sheets.
Paragraph (d), ‘‘hazard classification,’’
requires chemical manufacturers and
importers to evaluate chemicals
produced in their workplaces or
imported by them to classify their
health and physical hazards in
accordance with the Standard. For each
chemical, the chemical manufacturer or
importer must determine the hazard
classes, and the category of each class,
that apply to the chemical being
classified. Employers are not required to
classify chemicals unless they choose
not to rely on the classification
performed by the chemical
manufacturer or importer for the
chemical. Chemical manufacturers,
importers or employers classifying
chemicals must identify and consider
the full range of available scientific
literature and other evidence concerning
the potential hazards. There is no
requirement to test the chemical to
determine how to classify its hazards.
Mandatory Appendix A to § 1910.1200
shall be consulted for classification of
health hazards, and Mandatory
Appendix B to § 1910.1200 shall be
consulted for the classification of
physical hazards.
For mixtures, chemical
manufacturers, importers, or employers
evaluating chemicals must follow the
procedures described in Appendixes A
and B to § 1910.1200 to classify the
hazards of the chemicals, including
determinations regarding when
mixtures of the classified chemicals are
covered by the Standard. A chemical
manufacturer or importer of a mixture is
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responsible for the accuracy of the
classification of the mixture even when
relying on the classifications for
individual ingredients received from the
ingredient manufacturers or importers
on the safety data sheets.
Paragraph (f) modifies existing label
requirements by requiring more specific
information. Paragraph (f)(1) requires
chemical manufacturers, importers, or
distributors to ensure that each shipped
container of classified hazardous
chemicals leaving the workplace is
labeled, tagged, or marked with the
following information:
(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) Supplemental information as
appropriate.
Information provided under (i)
through (v) above must be in accordance
with mandatory Appendix C, Allocation
of Label Elements, for each hazard class
and associated hazard category for the
hazardous chemical; prominently
displayed; and in English (other
languages may also be included if
appropriate). In addition, the
information in (ii) through (iv) must be
located together on the label, tag, or
mark.
For containers of hazardous chemicals
that do not fall into one of the new
hazard classes, (f)(2) requires that the
label include the name of the chemical,
the name, address, and telephone
number of the manufacturer, importer,
or other responsible party, and, as
supplementary information, a
description of the unclassified hazards
and appropriate precautionary measures
to ensure the safe handling and use of
the chemical.
For labels in the workplace, except as
provided in paragraphs (f)(8) and (f)(9)
of the Standard, employers must ensure
that each container of hazardous
chemicals in the workplace is labeled,
tagged, or marked with either (i) the
information specified under (f)(1)(i)
through (v) for labels on shipped
containers: or, (ii) product identifier and
words, pictures, symbols, or
combination thereof, which provide at
least general information regarding the
hazards of the chemicals, and which, in
conjunction with the other information
immediately available to employees
under the hazard communication
program, will provide employees with
the specific information regarding the
physical and health hazards of the
hazardous chemical.
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OSHA is also proposing to update the
language for workplace signs and labels
to incorporate the GHS hazard statement
and the applicable precautionary
statement(s), where required. Most
OSHA substance-specific health
standards require hazard warning signs,
usually for regulated areas, and the
language required on the signs varies.
With the GHS revision, these standards
retain the requirements for specific
warning language for specific signs;
however, OSHA is proposing to modify
the language to be compatible with GHS
and consistent throughout the OSHA
standards. The GHS classification
process for a specific substance as
proposed in this revision of the HCS
will dictate the hazard warnings and the
precautionary statements that will be
required on the new GHS-compliant
labels. OSHA believes that having signs
and labels in the same formats and
containing identical warnings for the
same health effects will make it far
easier for employers and employees to
quickly recognize the hazard and the
degree of danger of a hazard, thus
enhancing communication.
The proposal modifies the
requirements for signs and labels found
in the Agency’s health standards listed
below. Since OSHA is providing
specific language for signs and for labels
on containers of contaminated clothing,
waste and debris, the Agency is
exempted from taking burden hours and
costs for these provisions. (See 5 CFR
1320.2(c)(2) (‘‘Controlling paperwork
burden on the public’’)). The Agency is
taking burden hours and costs for
employers to label, tag, or mark each
container of hazardous chemicals with
either (i) the information specified
under (f)(1)(i) through (v) for labels on
shipped containers: or, (ii) product
identifier and words, pictures, symbols,
or combination thereof, which provide
at least general information regarding
the hazards of the chemicals.
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GENERAL INDUSTRY
Asbestos 1910.1001 .................
13 Carcinogens 1910.1003 ......
Vinyl Chloride 1910.1017 .........
Inorganic Arsenic 1910.1018 ....
Lead 1910.1025 ........................
Chromium (VI) 1910.1026 ........
Cadmium 1910.1027 ................
Benzene 1910.1028 .................
Coke Oven Emissions
1910.1029 .............................
Cotton Dust 1910.1043 ............
1,2-dibromo-3-chloropropane
1910.1044 .............................
Acrylonitrile 1910.1045 .............
Ethylene Oxide 1910.1047 .......
Formaldehyde 1910.1048 .........
Methylenedianiline 1910.1050 ..
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1218–0133
1218–0085
1218–0010
1218–0104
1218–0092
1218–0252
1218–0185
1218–0129
1218–0128
1218–0061
1218–0101
1218–0126
1218–0108
1218–0145
1218–0184
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GENERAL INDUSTRY—Continued
1,3-Butadiene 1910.1051 .........
Methylene Chloride 1910.1052
Hazard Communication
1910.1200 .............................
1218–0170
1218–0179
1218–0072
Construction Industry
Methylenedianiline 1926.60 ......
Lead 1926.62 ............................
Asbestos 1926.1101 .................
Chromium 1926.1126 ...............
Cadmiun 1926.1127 .................
1218–0183
1218–0189
1218–0134
1218–0252
1218–0186
Paragraph (g)(2) requires the chemical
manufacturer or importer preparing the
safety data sheet (SDS) to ensure that it
is in English (although the employer
may maintain copies in other languages
as well), and include the following
section numbers and headings, and
associated information under each
heading, in the order listed (see
Appendix D to § 1910.1200—Safety Data
Sheets, for the specific content of each
section of the safety data sheet).
(i) Section 1, Identification;
(ii) Section 2, Hazard(s) identification;
(iii) Section 3, Composition/
information on ingredients;
(iv) Section 4, First-aid measures;
(v) Section 5, Fire-fighting measures;
(vi) Section 6, Accidental release
measures;
(vii) Section 7, Handling and storage;
(viii) Section 8, Exposure controls/
personal protection;
(ix) Section 9, Physical and chemical
properties;
(x) Section 10, Stability and reactivity;
(xi) Section 11, Toxicological
information.
Note 1 to paragraph (g)(2): To be
consistent with the GHS, an SDS must also
include the following headings in this order:
Section 12, Ecological information;
Section 13, Disposal considerations;
Section 14, Transport information; and
Section 15, Regulatory information.
Note 2 to paragraph (g)(2): OSHA will not
be enforcing information requirements in
sections 12 through 15, as these areas are not
under its jurisdiction.
(xii) Section 16, Other information,
including date of preparation or last
revision.
Paragraph (g)(5) requires the chemical
manufacturer, importer or employer
preparing the safety data sheet to ensure
that the information provided accurately
reflects the scientific evidence used in
making the hazard classification. If the
chemical manufacturer, importer or
employer preparing the safety data sheet
becomes newly aware of any significant
information regarding the hazards of a
chemical, or ways to protect against the
hazards, this new information must be
added to the safety data sheet within
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three months. If the chemical is not
currently being produced or imported,
the chemical manufacturer or importer
must add the information to the safety
data sheet before the chemical is
introduced into the workplace again.
Paragraph (g)(11) requires that
employers ensure the safety data sheets
are readily available, upon request, to
designated representatives, the Assistant
Secretary, and the Director, in
accordance with the requirements of 29
CFR 1910.1020(e).
Affected Public: Business or other forprofit.
Number of Respondents: 90,801 firms
producing Safety Data Sheets and labels.
Frequency: One time.
Average Time per Response: Time to
convert Safety Data Sheets and labels to
the new system ranges from 7 hours for
establishments having between 1 to 19
employees; to 3 hours for
establishments having greater than 500
employees.
Estimated Total Burden Hours:
2,125,414.
Estimated Costs (Operation and
Maintenance): $32,055,258.
Submitting comments. Members of
the public who wish to comment on the
paperwork requirements in this
proposal should send their written
comments to the Office of Information
and Regulatory Affairs, Office of
Management and Budget, Room 10235,
New Executive Office Building,
Washington, DC 20503; Attn: OSHA
Desk Officer (RIN 1218–AC20). The
Agency encourages commenters also to
submit their comments on these
paperwork requirements to the
rulemaking docket, along with their
comments on other parts of the
proposed rule. Comments may be
submitted by using the Federal
eRulemaking portal at https://
www.regulations.gov. Comments and
submissions are posted without change;
therefore OSHA cautions commenters
about submitting personal information
such as social security numbers and
date of birth. Information on using the
https://www.regulations.gov Web site to
submit comments and access the docket
is available at the Web site’s ‘‘User
Tips’’ link. For instructions on
submitting these comments to the
rulemaking docket, see the sections of
this Federal Register notice titled DATES
and ADDRESSES.
Docket and inquiries. To access the
docket in order to read or download
comments and other materials related to
this paperwork determination,
including the complete Information
Collection Request (ICR) (containing the
Supporting Statement (describing the
paperwork determinations in detail) and
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attachments), use the procedures
described under the section of this
notice titled ADDRESSES. To make
inquiries, or to request other
information, contact Mr. Todd Owen,
Directorate of Standards and Guidance,
OSHA, Room N–3609, U.S. Department
of Labor, 200 Constitution Avenue,
NW., Washington, DC 20210; telephone
(202) 693–2222.
IX. Federalism
The Agency reviewed the proposed
Hazard Communication Standard
according to the Executive Order on
Federalism (Executive Order 13132, 64
FR 43255, August 10, 1999). This
Executive Order requires that Federal
agencies, to the extent possible, refrain
from limiting State policy options,
consult with States before taking actions
that restrict their policy options, and
take such actions only where there is
constitutional and statutory authority to
do so and the problem is of national
significance. The Executive Order
generally allows Federal agencies to
preempt State law only where there is
clear evidence of Congressional intent to
allow it, or where the exercise of State
authority would conflict with the
exercise of Federal authority under a
statute; in such cases, Federal agencies
must limit preemption of State law to
the extent possible. Section 18 of the
Occupational Safety and Health Act (the
‘‘Act’’ or ‘‘OSH Act’’), 29 U.S.C. 667,
expresses Congress’ clear intent to
preempt State laws with respect to
issues for which OSHA has promulgated
an occupational safety and health
standard under section 6 of the Act.
Under section 18 of the Act, a State may
avoid preemption only if it submits and
obtains OSHA approval of an
occupational safety and health plan. See
Gade v. National Solid Wastes
Management Association, 112 S. Ct.
2374 (1992).
With respect to States that do not
have OSHA-approved plans, the Agency
concludes that this proposal falls under
the preemption provisions of the Act.
Additionally, section 18 of the Act
prohibits States without approved plans
from issuing citations for violations of
OSHA standards; the Agency finds that
this proposed rulemaking does not
expand this limitation. OSHA has
authority under Executive Order 13132
to propose a Hazard Communication
Standard because the problems
addressed by these requirements are
national in scope.
Section 18(c)(2) of the Act permits
State-plan states to develop their own
requirements to deal with any special
workplace problems or conditions,
provided, inter alia, these requirements
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are at least as effective as the Federal
standards promulgated under section 6
of the Act. Although a State standard
becomes effective in accordance with
State promulgation provisions, and is
enforceable upon promulgation, OSHA
must also review and approve the
standard to assure that it is ‘‘at least as
effective’’ as the Federal standard.
OSHA intends to closely scrutinize
State hazard communication standards
submitted under current or future State
plans to assure equal or greater
effectiveness, including assurance that
any additional requirements do not
conflict with, or adversely affect, the
effectiveness of the national application
of OSHA’s standard. OSHA must
determine in its review whether any
State plan standard provisions that
differ from the Federal provisions, when
applicable to products distributed or
used in interstate commerce, are
‘‘required by compelling local
conditions and do not unduly burden
interstate commerce.’’ OSH Act section
18(c), 29 U.S.C. 667(c).
X. State Plans
The 26 States and territories with
their own OSHA-approved occupational
safety and health plans must adopt
comparable provisions within six
months after the Agency publishes a
final standard. These States and
territories 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, Virgin Islands, Washington,
and Wyoming. Connecticut, New Jersey
and New York have OSHA approved
State Plans that apply to State and local
government employees only. Each stateplan State’s existing requirements will
continue to be in effect until it adopts
the required revisions.
XI. Unfunded Mandates
Under Section 202 of the Unfunded
Mandates Reform Act of 1995, 2 U.S.C.
1532, an agency must prepare a written
‘‘qualitative and quantitative
assessment’’ of any regulation creating a
mandate that ‘‘may result in the
expenditure by the State, local, and
tribal governments, in the aggregate, or
by the private sector, of $100,000,000 or
more’’ in any one year before issuing a
notice of proposed rulemaking. OSHA’s
proposal does not place a mandate on
State or local governments, for purposes
of the UMRA, because OSHA cannot
enforce its regulations or standards on
State or local governments. (See 29
U.S.C. 652(5).) Under voluntary
agreement with OSHA, some States
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50381
enforce compliance with their State
standards on public sector entities, and
these agreements specify that these State
standards must be equivalent to OSHA
standards. The OSH Act also does not
cover tribal governments in the
performance of traditional governmental
functions, though it does when tribal
governments engage in commercial
activity. However, the proposal would
not require tribal governments to
expend, in the aggregate, $100,000,000
or more in any one year for their
commercial activities. Thus, although
OSHA may include compliance costs for
affected governmental entities in its
analysis of the expected impacts
associated with a proposal, the proposal
does not trigger the requirements of
UMRA based on its impact on State,
local, or tribal governments.
Based on the analysis presented in the
Preliminary Economic Analysis (section
VII above), OSHA concludes that the
proposal would impose a Federal
mandate on the private sector in excess
of $100 million in expenditures in any
one year. The Preliminary Economic
Analysis constitutes the written
statement containing a qualitative and
quantitative assessment of the
anticipated costs and benefits required
under Section 202(a) of UMRA (2 U.S.C.
1532).
XII. Protecting Children From
Environmental Health and Safety Risks
Executive Order 13045 requires that
Federal agencies submitting covered
regulatory actions to OMB’s Office of
Information and Regulatory Affairs
(OIRA) for review pursuant to Executive
Order 12866 must 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. Executive Order 13045 defines
‘‘covered regulatory actions’’ as rules
that may (1) be economically significant
under Executive Order 12866 (i.e., a
rulemaking that has an annual effect on
the economy of $100 million or more, or
would adversely effect 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
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that children are likely to come in
contact with or ingest (e.g., through air,
food, water, soil, product use). The
proposed HCS is economically
significant under Executive Order 12866
(see section VII of this preamble).
However, after reviewing the proposed
HCS, OSHA has preliminarily
determined that the standard would not
impose environmental health or safety
risks to children as set forth in
Executive Order 13045.
XIII. Environmental Impacts
The Agency reviewed the proposed
Hazard Communication Standard
according to the National
Environmental Policy Act (NEPA) of
1969 (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 this review, OSHA has
made a preliminary determination that
the proposed HCS 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 concludes that the proposed HCS
would have no significant
environmental impacts.
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XIV. Public Participation
OSHA encourages members of the
public to participate in this rulemaking
by submitting comments on the
proposal.
Written Comments. OSHA invites
interested persons to submit written
data, views, and arguments concerning
this proposal. In particular, OSHA
encourages interested persons to
comment on the issues raised in section
II of this preamble. When submitting
comments, persons must follow the
procedures specified above in the
sections titled DATES and ADDRESSES.
The comments must clearly identify the
provision of the proposal you are
addressing, the position taken with
respect to each issue, and the basis for
that position. Comments, along with
supporting data and references, received
by the end of the specified comment
period will become part of the record,
and will be available for public
inspection and copying at the OSHA
Docket Office as well as online at
www.regulations.gov (Docket Number
H022K–2006–0062).
Informal Public Hearing. Pursuant to
section 6(b)(3) of the Act, members of
the public will have an opportunity to
provide oral testimony concerning the
issues raised in this proposal at informal
public hearings. The hearings will be
announced in the Federal Register.
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XV. Summary and Explanation of the
Proposed Standard
The advance notice of proposed
rulemaking (ANPR) published by OSHA
on September 12, 2006 (71 FR 53617)
included a series of questions to solicit
information on a number of specific
topics. The responses from more than
100 commenters have been used by the
Agency to help prepare the required
analyses for this rulemaking, as well as
to make determinations regarding the
proposed text. The discussion below on
each paragraph of the proposed
standard addresses the comments that
were related to those subjects, and the
discussion on the regulatory impact
analysis in Section VII of this preamble
refers to responses related to that topic.
In addition to the responses to
specific questions in the ANPR, OSHA
has also received general comments
covering topics such as statements of
support for the rulemaking, approaches
or principles to follow in the rule,
suggestions for outreach and
compliance assistance, and other
subjects of concern. Before addressing
the specific paragraphs of the proposed
rule, we would like to discuss these
general comments.
Support for the rulemaking. Many of
those who responded to the ANPR
expressed their support for adoption
and implementation of the GHS. The
supporters far out numbered those who
opposed or questioned adoption (see,
e.g., Document ID #s 0003, 0007, 0047,
0050, 0052, 0062, 0106, 0011, 0033,
0038, 0123, 0130, 0151, 0163, and
0171). The reasons presented for this
support varied, but included the belief
that adoption of the GHS will bring
consistency and clarity to hazard
communication (e.g., Document ID #s
0046, 0059, 0081, and 0038); will help
to ensure that employees have reliable,
consistent, comprehensive and
comprehensible information (e.g.,
Document ID #s 0054, 0030, 0037, and
0124); will help to enhance human
health and the environment (improved
worker safety) (e.g., Document ID #s
0064, 0081, 0032, and 0128); and will
reduce burdens associated with
preparing multiple classifications and
labels for the same product (e.g.,
Document ID #s 0048, 0080, 0030, and
0123).
Support for implementation of the
GHS by OSHA was expressed by both
users and producers of chemicals. For
example, the Aerospace Industries of
America, Inc., representing companies
that are generally large users of
chemicals, identified many of these
benefits in its statement of support
(Document ID # 0054):
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AIA supports OSHA’s current efforts to
adopt the GHS and its past participation in
the development of the UN’s GHS for
classification and communication of
chemical hazards. We believe that the GHS
adoption will help bring consistency and
clarity to national and international
regulation of hazardous chemicals and will
help ensure that employers and employees
have reliable, consistent, and comprehensive
information on hazardous chemicals in the
workplace. With the great diversity in the
current systems of hazard communications
globally, where MSDSs and chemical labels
and classification systems vary in content
details and length, type of information,
format, and depth of hazard warnings and
procedures, there is often inconsistency,
redundancy, and incompatibility in labels
developed by manufacturers and distributors.
This often results in confusion for workers
who try to interpret the MSDSs and labels,
particularly across differing industry sectors
and geographic areas where language,
culture, and levels of experience and training
may vary. OSHA’s proposal to adopt
applicable provisions of the GHS into the
U.S. workplace is a positive step in working
toward developing standardized, uniform,
classification, labeling, and related
procedures for worker hazard
communications systems.
The United Parcel Service, Inc., also
a user of chemicals as well as a
transporter, supported implementation
of the GHS too (Document ID # 0064):
UPS is pleased to support OSHA’s
adoption of the GHS and applauds the
publication of the ANPRM as an important
step toward implementation. We believe that
the implementation of the GHS has the
potential to (1) contribute to the safety of
workers through standardized and more
easily understood Safety Data Sheets
(‘‘SDSs’’); (2) streamline domestic hazard
classification and labeling across all
pertinent U.S. agencies (OSHA, EPA, DOT,
CPSC); and (3) facilitate international trade in
chemical-based products by harmonizing
hazard communication requirements across
national borders. UPS also recognizes that
the current HAZCOM standard, while not
perfect, has helped promote the safety and
health of American workers. We believe that
OSHA can reap the benefits of the GHS
without compromising the substantial
benefits of the existing HAZCOM regime.
The American Federation of Labor
and Congress of Industrial
Organizations (AFL–CIO), representing
employees exposed to chemicals in the
workplace, also recognized the value of
revising the HCS to adopt the GHS
provisions (Document ID # 0124):
[T]he GHS offers a standardized and
specific approach to the creation of labels
and Safety Data Sheets (SDS), with a set
format, content and order. Additionally, the
GHS has an established set of hazard criteria
and employs the use of standardized
pictograms. We believe these elements of the
GHS, when incorporated into the HCS, will
assist greatly in generating labels and SDS’s
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that are vastly more consistent and
comprehensible in comparison to the current
MSDS’s and labels. The improved
consistency will also increase the ability to
communicate the hazard information to
workers. The AFL–CIO fully supports the
efforts of OSHA to modify the HCS so that
these objectives are realized.
Similarly, DuPont, a major chemical
manufacturer, also expressed its support
for pursuing harmonization through
adoption of the GHS (Document ID #
0038):
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DuPont supports OSHA adoption of the
GHS and the publication of this ANPRM as
a concrete step towards implementation of
the GHS in the United States. DuPont urges
OSHA to use the information received in
response to this ANPRM and move quickly
and judiciously to the next step towards a
globally harmonized system—publication of
a proposed rule. DuPont believes that
implementation of the GHS will mean that
workers who must handle hazardous
chemicals will find hazard information
presented in a standardized and more
comprehensible manner. DuPont also
believes that implementation of the GHS will
ultimately reduce the costs to businesses of
classifying chemicals as to their hazards and
creating warning labels and safety data
sheets.
While support for implementation of
the GHS was widespread in the
comments, these supporters also
recognized the challenges associated
with implementation. For example, it
was noted by a number of commenters
that there will be short-term costs
associated with implementation, and
they urged OSHA to take steps to
minimize them by providing a
reasonable time period for phase-in,
coordinating with other agencies, and
providing extensive outreach (see, e.g.,
Document ID #s 0032, 0111, 0155, 0157,
and 0162). As will be addressed in other
parts of this preamble, OSHA also
recognizes the costs associated with
implementation of the changes
necessitated by adoption of the GHS,
and has taken a number of steps to
address them, including those
recommended by these and other
commenters.
Others were concerned that the GHS
is not completely harmonized because it
allows countries and agencies within
countries, to select from among a
collection of building blocks when
determining the scope of their
requirements (e.g. Document ID # 0076).
The GHS was designed in this manner
because the existing systems all had
scope accommodations for different
sectors. For example, the most notable
difference among sectors involves
transport of dangerous goods and the
workplace. In the transport sector, only
those hazards which involve the types
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of exposures expected to be encountered
in transport are covered. In the area of
health effects, this has been defined as
acute health effects, and the transport
sector does not include any chronic
health hazards in its coverage.
Representatives of transport authorities
involved in the negotiations indicated
that this coverage was considered
appropriate, and the building block
concept that allowed them to continue
to have that scope was necessary to
include transport within the GHS. On
the other hand, workplace authorities
are concerned about chronic health
hazards occurring as a result of
workplace exposures, and expected the
GHS to include those types of effects.
Thus the GHS does not specify that all
provisions should be applied to all
sectors.
However, as will be addressed below
in specific paragraphs where this may
be a concern, OSHA does not presently
preclude employers from including
additional information on labels and
safety data sheets to address areas that
are not covered by OSHA, and would
not do so when implementing the
proposed revisions. For example, where
employers are preparing labels and
SDSs for products that will be marketed
in both the consumer and the workplace
sector, additional information on acute
toxicity at lower levels of concern may
be included for the consumer sector
without violating any current or
proposed OSHA requirements.
Similarly, information regarding
transportation and environmental
concerns may be included on SDSs
required by OSHA. However, the
Agency only enforces the standard with
regard to the information required under
its own provisions. The same situation
would apply in implementation of the
proposed revisions.
In addition to those who supported
implementation, but raised areas of
concern regarding the way in which it
is pursued, there were others who did
not support implementation (Document
ID #s 0004, 0065, 0068, and 0108).
These commenters argued that it would
be too financially burdensome
(Document ID # 0004); delegates power
to an international body which can only
be accomplished through a treaty, if at
all (Document ID # 0065); would change
the current hazard communication
scheme and thus potentially impair
safety (Document ID # 0065); and
should not be applied to pesticides
because they are already heavily
regulated (Document ID # 0108).
With regard to the costs and economic
impacts, OSHA has prepared extensive
analyses of the costs, benefits, and
economic impacts of the rules, which
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50383
are summarized in Section VII of this
preamble. The Agency has preliminarily
concluded that the draft proposed
standard is an economically significant
rule under E.O. 12866 in that the costs
exceed $100 million in each of the first
three years. However, OSHA will certify
that a regulatory flexibility analysis is
not necessary under the Regulatory
Flexibility Act (RFA), because although
the proposed standard will affect a
substantial number of small firms, the
impacts do not rise to the level of
significance that would require a
regulatory flexibility analysis under the
RFA.
Section VI of the preamble addresses
the legal authority of the Agency to
pursue this rulemaking. OSHA believes
that adoption of the GHS through
rulemaking is the appropriate
mechanism to achieve this increased
protection for exposed employees as
well as global harmonization, and that
a treaty is not the only means to
accomplish this goal. More importantly,
however, adoption of the GHS through
rulemaking does not delegate ‘‘power to
an international body’’ as argued by the
National Association of Home Builders
(Document ID # 0065). NAHB also
argues that the proposal would allow
hazard determinations ‘‘to be based on
something other than fact and scientific
evidence.’’
This rulemaking process is the legal
means to modify the current HCS
requirements to make them consistent
with GHS. Promulgation of the GHS
modifications and implementation of
the revised HCS will be by OSHA under
the Agency’s authority in the OSH Act.
No international body will dictate the
terms of the adoption. Moreover, there
will be no international body with any
authority in American workplaces with
regard to hazard communication.
Furthermore, the hazard determination
process under the HCS is currently
based on an evaluation of scientific facts
and evidence, and would continue to be
so under the revised HCS as proposed.
The proposed revisions simply provide
more extensive guidance on the
scientific approach to hazard
classification to help ensure a consistent
evaluation process by multiple chemical
manufacturers. As will be discussed in
other parts of this preamble, OSHA
believes that adoption of the GHS would
lead to increased accuracy and
reliability in evaluations of scientific
evidence, and thus better information
for employers and employees to use to
protect them in the workplace.
OSHA believes that arguments
presented in this preamble, and the
accompanying analyses, indicate that
pursuing modifications to the HCS will
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enhance employee protection, as well as
ultimately facilitate compliance for all
companies including those in the
construction industry that use
hazardous chemicals.
Therefore, while OSHA did not
include questions regarding the support
of stakeholders for adoption of the GHS,
it is clear that a majority of those
responding to the ANPR support
moving forward with the rulemaking.
The arguments presented by those few
who actively objected to adoption have
been addressed in this preamble and the
analyses for the rule, and have not been
found persuasive. Other issues raised by
supporters as concerns or suggestions
for addressing concerns, have also been
addressed in the proposed rule. While
OSHA has addressed many of the
identified issues in the proposal, the
Agency recognizes that stakeholder
input is needed to resolve some of the
concerns, and these have been described
in Section II.
Other general issues. Commenters
also raised a number of other issues
related to the rulemaking that were not
directed to specific paragraphs of the
HCS. Some respondents indicated that
OSHA should limit changes to the HCS
to those required to align with the GHS,
thus keeping the framework of the
existing HCS (see, e.g., Document ID #s
0047, 0080, 0104, 0123, 0145, 0163,
0167, and 0170). For example, ORC
Worldwide (Document ID # 0123)
stated:
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* * *[O]SHA can help minimize the cost
to businesses by only modifying those
sections of the OSHA Hazard
Communication Standard (HCS) that must be
changed to be consistent with GHS.
Therefore, we strongly support OSHA’s
stated intent to maintain the current scope,
application, and interpretations of the HCS,
and only modify those sections of the
standard necessary for consistency with the
GHS. Not only will this help minimize the
implementation burden on industry, it
should also serve to minimize confusion
among employers and employees during the
implementation period.
As will be described in greater detail
below with regard to specific
provisions, OSHA has made every effort
to maintain the framework of the
current HCS in the proposed revisions.
The modifications proposed are
believed by OSHA to be those that are
required to align the current HCS with
the GHS, but do not address provisions
of the current standard that are not
addressed in the GHS. Thus, for
example, the scope and application
paragraph remains largely unchanged,
as does the paragraph addressing trade
secret protection. The primary
modifications proposed in these
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paragraphs are changes in terminology
required to ensure consistency.
Many commenters also suggested that
OSHA should coordinate
implementation of the GHS with other
Federal agencies. These included
primarily EPA, DOT, and CPSC (see, e.g.
Document ID #s 0048, 0050, 0053, 0076,
0104, 0111, 0123, 0134, 0154, 0162, and
0170). Others mentioned the Mine
Safety and Health Administration
(MSHA) (Document ID #s 0049, 0101,
and 0111). For example, the Soap and
Detergent Association (Document ID #
0170) stated:
SDA urges OSHA to coordinate
implementation of revisions to the HCS
related to the GHS with the Environmental
Protection Agency (EPA), Department of
Transportation (DOT), and the Consumer
Product Safety Commission (CPSC), which
all have announced their intentions to
implement GHS provisions in their
regulations. Workplace hazard
communication occurs in a stage of the
overall life cycle of chemicals and finished
products. Coordination and synchronization
of implementation timing could greatly
improve the efficiency of implementation of
the GHS by industry.
OSHA agrees with these commenters
that the U.S. government agencies
should continue to coordinate their
activities with regard to implementation
of the GHS. In terms of adopting the
GHS provisions, DOT has substantially
aligned the criteria for physical hazards
in their regulations with those of the
GHS under the HM–215I rulemaking (71
FR 78595). EPA and CPSC have not
initiated rulemaking on the GHS. Thus
at this point, there is little to coordinate
in terms of timelines. As rulemaking
develops in these Agencies, discussions
will continue to take place in the
interagency committee on this subject.
With regard to MSHA, Department of
Labor rulemaking activities are
coordinated through Department
officials, and MSHA has been apprised
of OSHA’s activities in order to
determine what action may be
appropriate for them to pursue in this
area.
A number of commenters also argued
that OSHA should coordinate
implementation with major U.S. trading
partners (see, e.g., Document ID #s 0042,
0048, 0101, 0116, 0128, 0141, 0155, and
0170). Similarly, several argued that
countries should limit modifications to
the GHS that are country-specific, and
that the UN process should be used to
control such changes (Document ID #s
0042, 0018, 0134, 0154, 0163, 0164, and
0171). For example, the American
Petroleum Institute (API) addressed
these issues as follows (Document ID #
0171):
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API strongly recommends that OSHA
ensure that timing and coordination of GHS
implementation schedules are in line with
those of other countries, allowing sufficient
time for companies to organize and
accomplish necessary work. In order to
achieve international harmonization of
hazard communication materials and to
avoid undue burden on companies, OSHA
must stay engaged with all other actors to
encourage even and consistent
implementation of GHS by individual
countries. Further, API recommends that
OSHA work closely with other government
agencies and countries to ensure alignment to
the UN endorsed version of the GHS. As the
implementation of the GHS by countries
deviates from the UN version of GHS, the
perceived benefits of harmonization
substantially decrease.
OSHA agrees with these commenters
that coordination among trading
partners would enhance harmonization
and facilitate implementation. The
Agency remains active in the UN
process, participating in the
Subcommittee of Experts on the GHS, as
well as the UNITAR Programme
Advisory Group. There is increased
emphasis in the Subcommittee on
implementation issues as well as
coordination. OSHA led a
correspondence group that reviewed
implementation of the mixture
classification provisions, and
modifications to address concerns
raised were incorporated into Revision
3 of the GHS to help ensure consistency
in approach. OSHA will continue to
lead a correspondence group on
practical classification and hazard
communication issues. In addition, the
Subcommittee has established a
correspondence group to address
broader implementation issues, and
OSHA is participating in those
deliberations as well.
The Agency has also had bilateral
discussions in the past with Canada, as
well as the European Union (EU), on
issues related to implementation. These
are two of the key trading partners for
the U.S. The EU has recently revised its
overall approach to the regulation of
chemicals in a new European
Community Regulation (EC 1907/2006)
referred to as REACH: Registration,
Evaluation, Authorization and
Restriction of Chemical substances. The
new law entered into force on June 1,
2007, and the provisions will be phased
in over 11 years. REACH addresses
chemical hazards over the life cycle of
a chemical, and gives greater
responsibility to industry to manage the
risks from chemicals and to provide
safety information on substances.
Manufacturers and importers will be
required to gather information on the
properties of their chemical substances,
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which will allow their safe handling,
and to register the information in a
central database run by the new
European Chemicals Agency (ECHA).
The Agency will act as the central point
in the REACH system: it will manage
the databases necessary to operate the
system, coordinate the in-depth
evaluation of suspicious chemicals, and
run a public database in which
consumers and professionals can find
hazard information.
On September 3, 2008, the EU
Parliament completed revisions to its
longstanding chemical classification
and labeling approach to align with the
GHS (referred to now as the European
Regulation on the Classification,
Labelling, and Packaging of Substances
and Mixtures). It applies to substances
as of December 1, 2010, and mixtures as
of June 1, 2015. The final version was
published in the EU Official Journal on
December 31, 2008.
In terms of these proposed provisions,
OSHA examined the European
Commission’s regulation to coordinate
where possible on approaches to
implementation. However, the primary
principles followed by OSHA in
developing this proposal were to ensure
that the modifications maintain or
enhance the protections of the current
standard, and that the modifications are
consistent with the negotiated
provisions of the GHS.
One of the issues of concern regarding
implementation by some other countries
has been deviation from the GHS itself.
Because GHS is intended to be globally
implemented, efforts by countries to
deviate in a collective manner from the
GHS, rather than maintaining
consistency, defeats the purpose, and
consequently, lessens the benefits of the
GHS. OSHA will continue to seek
opportunities to ensure coordination of
implementation and promote
harmonization, both internationally and
bilaterally.
It should also be noted that the GHS
is a living document, and the UN
actively reviews it and considers
possible changes based on
implementation experiences and other
information. These changes are made on
a two-year cycle, referred to as a
biennium. The OSHA proposal is based
on Revision 3 of the GHS. Revision 3
was adopted by the UN Subcommittee
of Experts on the GHS (UNSCEGHS) in
December 2008. A compilation of the
approved changes is available on the
UN Web site (ST/SG/AC.10/36/Add. 3),
and the full text of Revision 3 will be
accessible later this year. There are a
number of clarifications and small
modifications in Revision 3 that address
inconsistencies or discrepancies in the
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previous text of the GHS, and these have
been incorporated into this proposal.
It is expected that as the UNSCEGHS
fulfills its mandate to ensure that the
GHS is up-to-date and relevant, further
changes will be adopted on a biennium
basis. If the change(s) is substantive and
controversial, OSHA will have to engage
in notice and comment rulemaking in
order to amend the HCS. However, for
non-substantive or clarification changes,
OSHA has rulemaking options available
that can be utilized to implement the
changes and can be done more quickly
than the full notice and comment
rulemaking process.
Two possible means are the
Standards’ Improvement Process (SIPs)
or a Direct Final Rule (DFR). Each of
these options also gives the public
notice and opportunity to comment, but
has the advantage of a faster process.
Either method could be used to ensure
that the HCS remains current with the
GHS.
Outreach/Compliance Assistance.
The ANPR included a series of
questions to solicit input from the
public on what outreach or compliance
assistance materials would be
appropriate and useful. OSHA received
many comments in response to these
questions, with a number of creative
and interesting suggestions for outreach
products. The Agency will use this
input to develop an outreach plan and
prepare materials for distribution when
the rulemaking is completed. In
addition, and as suggested by a number
of commenters (see, e.g., Document ID
#s 0047, 0065, 0081, 0104, 0018, 0025,
and 0154), OSHA will continue working
with its partners, alliances and other
interested parties to examine projects
that could be completed by them, or in
coordination with them, that could be
targeted to specific industries or interest
groups.
With regard to the questions on the
media through which to distribute
materials, all of the methods mentioned
in the ANPR received considerable
support. In addition, a number of
commenters indicated that all types of
distribution systems should be used to
reach the widest audience, including
the Web site, electronic tools,
PowerPoint presentations, flash videos,
a dedicated web page, mail, train-thetrainer sessions, regional workshops,
etc. All of the possible subjects
suggested by OSHA (e.g., hazard
classification, labels, and safety data
sheets) were also endorsed as being of
interest.
Many commenters agreed with OSHA
that training on understanding
pictograms and symbols, as well as
hazard statements, signal words, labels,
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and SDSs, would be useful for both
small businesses and employees (see,
e.g., Document ID #s 0044, 0061, 0072,
0028, 0034, 0107, 0139, 0163, and
0170). There were also several
recommendations that OSHA prepare a
poster with the pictograms that can be
displayed in workplaces (Document ID
#s 0046, 0047, 0064, 0028, 0123, and
0171).
In addition, it was suggested that
training on classification procedures,
particularly for mixtures, would be
useful, as would software that could
complete mixture calculations (see, e.g.,
Document ID #s 0046, 0054, 0032, 0038,
0128, 0140, and 0154). And a number of
respondents believe that OSHA should
develop a series of training modules on
different aspects of the revised HCS
(Document ID #s 0047, 0051, 0080,
0025, and 0135), and provide training
online (Document ID #s 0059, 0032,
0125, 0129, 0155, and 0157).
Commenters also suggested that
OSHA prepare a comprehensive
comparison of the current standard to
the revised HCS when completed
(Document ID #s 0054, 0135, and 0145),
as well as a reference table with
different requirements around the world
(Document ID #s 0047, 0080, 0123, and
0171). It was also noted that materials
should be available in multiple
languages (Document ID #s 0046 and
0080).
Other ideas presented included
electronic seminars (Document ID #
0064); model programs (Document ID #s
0064, 0076, 0080, 0029, and 0124);
toolbox talks (Document ID # 0065);
Quick Cards (Document ID # 0065);
online inventory lists (Document ID #s
0076 and 0178); Q and A document
(Document ID #s 0072 and 0160);
hotline (Document ID #s 0077, 0104,
0179, 0140, and 0163); GHS resource CD
(Document ID #s 0021 and 0155); SDS
template (Document ID #s 0144 and
0145); timely compliance directive
(Document ID # 0124); and approximate
conversion table for classifications
(Document ID #s 0145 and 0163).
The proposed standard. The
following is a description of the
provisions of the proposed standard.
Comments received that were related to
the proposed provisions are also
addressed.
(a) Purpose. The HCS includes a
paragraph that states the purpose of the
rule. This stated purpose is two-fold.
First, the paragraph indicates that the
standard addresses assessment of the
hazards of workplace chemicals, and the
transmittal of that information to
employers and employees. It also
describes the contents of a
comprehensive hazard communication
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program as being container labeling and
other forms of warning, material safety
data sheets, and employee training.
The second part of the paragraph
addresses the preemption of State or
local laws by this Federal standard. It
indicates that OSHA is addressing
comprehensively the issues described,
and thus the standard preempts States,
and political subdivisions of States,
from addressing these issues except
under the authority of a Federallyapproved State plan under Section 18 of
the OSH Act. While Section 18 applies
to every occupational safety and health
standard that OSHA promulgates, the
HCS raises particular issues because of
the nature of the provisions. It requires
chemical manufacturers and importers
to evaluate the hazards of the chemicals
they produce or import, and to prepare
labels and material safety data sheets
based on those evaluations to transmit
hazard information and appropriate
precautionary advice to users
downstream. This is a unique, but
highly appropriate approach for an
OSHA standard, as it recognizes that
chemical manufacturers and importers
are in the best position to assess the
hazards of their products and develop
appropriate information for labels and
SDSs.
There is a national, indeed
international, marketplace for industrial
chemicals, and thus chemical
manufacturers and importers affect
commerce within the meaning of the
OSH Act and therefore fall under
OSHA’s jurisdiction. If a State or a
political subdivision of a State, were to
establish different requirements for
labels and safety data sheets, such
requirements would have an impact on
chemical manufacturers and importers
that are not located in that State. This
is a burden that the HCS eliminates by
establishing national requirements.
The proposed revision to HCS has
essentially the same purposes, and
OSHA is proposing only minor
modifications to this paragraph.
Paragraph (a)(1)would change the
language regarding the assessment of
hazards to indicate that the hazards will
be ‘‘classified’’ rather than simply
assessed or evaluated. This is consistent
with the approach in the GHS. In
addition, OSHA is proposing to modify
this paragraph to clearly indicate that
the standard is intended to be consistent
with the GHS, Revision 3. That change
is a reflection of the purpose of this
rulemaking to harmonize the existing
requirements with the provisions of the
GHS, which is the international
instrument that includes globally
harmonized provisions on hazard
communication. In addition, in this
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paragraph and succeeding paragraphs of
the revised rule, the term ‘‘material
safety data sheet’’ has been modified to
‘‘safety data sheet’’ to reflect the
terminology of the GHS.
The only modifications proposed to
paragraph (a)(2) also address
terminology, using ‘‘classifying’’ instead
of ‘‘evaluating’’, and ‘‘safety data sheet’’
instead of ‘‘material safety data sheet’’.
There were no specific comments
received in response to the ANPR
regarding the Purpose paragraph of the
HCS. One comment suggested that the
standard should be limited to a purpose
of international communication so as
not to trigger hazard assessments under
other OSHA standards that address
respiratory protection, personal
protective equipment, or process safety
management (Document ID # 0049).
There were several other comments that
indicated that new assessments would
have to be done for these standards
(Document ID #s 0178, 0111, 0134, and
0164). Arguments were made that this
would lead to extensive additional costs
for new engineering controls,
respirators, or other personal protective
equipment.
As discussed above, there is no
identified link to these other standards
in the stated purpose of the HCS either
currently or with the proposed
modifications. While the HCS itself
requires the provision of information on
recommended control measures,
including respiratory protection,
personal protective equipment, and
engineering controls, there is no
requirement for employers to implement
the recommended controls. All
information available to an employer
when designing an appropriate
protective program must be used, but a
recommendation on a safety data sheet
by itself would not trigger the need to
implement new controls.
Furthermore, these comments seem to
imply that there will be major changes
in the hazards of chemicals based on
implementation of the GHS provisions.
Both the HCS and the GHS are based on
identifying and communicating the
inherent hazards of chemicals. Thus the
biggest change for most chemicals under
the proposal will be in categorizing the
chemical’s hazards. Under the current
standard, for example, a chemical either
is, or is not, a carcinogen. Under the
revised HCS, if a chemical is a
carcinogen, it would be categorized as a
Category 1 or a Category 2 carcinogen.
Such a change would not generally
result in a need to change engineering
controls or respiratory protection.
It is possible that a chemical may be
classified under the proposal as having
a hazard it did not have before, but
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OSHA believes that this is not likely to
happen frequently given the broad
coverage of the current rule.
Furthermore, the physical and chemical
characteristics of the chemical—which
affect the types of protection required—
would not be changed as a result of this
proposal. OSHA believes that these
revisions would result in few, if any,
changes in protective measures required
under other OSHA standards.
Several commenters noted what they
believed to be the continued need to
address the preemption of State
standards (see, e.g., Document ID #s
0048, 0056, 0080, 0178, 0036, 0123, and
0135). In addition, commenters also
noted that the impact of GHS adoption
on State and local laws should be
considered in the process (for example,
California Proposition 65), and that
differences between such laws and the
revised HCS should be discouraged
(Document ID #s 0042, 0072, 0015, and
0038).
It was also indicated that changes in
State laws should be coordinated with
the Federal changes to facilitate
implementation (Document ID # 0146).
See Section IX and X of this preamble
for a comprehensive discussion
regarding Federalism and State plans.
(b) Scope and Application. The HCS
is a generic standard that has very broad
provisions in terms of chemicals
addressed and workplaces covered. It
also interfaces with a number of
requirements of other Federal agencies
that address labeling of chemical
hazards. Paragraph (b) thus includes all
of the practical modifications the
Agency has developed to ensure that
employers and employees understand
how the standard is to be applied, and
to accommodate various circumstances
that potentially affect the application of
the standard.
The provisions of paragraph (b)(2) in
the HCS address the overall scope of the
standard as applying to ‘‘any chemical
which is known to be present in the
workplace in such a manner that
employees may be exposed under
normal conditions of use or in a
foreseeable emergency.’’ This provision
addresses many questions that are
raised about the application of the
standard. There was one comment
received regarding this paragraph which
indicated that hazard classification and
labeling of steel for chronic health
effects should not result from welding
being considered a normal condition of
use (Document ID # 0160). OSHA has
made it clear in past interpretations of
the rule that where such products are
intended to be welded, this information
must be provided for hazard
communication purposes. That
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interpretation does not change as a
result of the proposed provisions in the
revised rule.
In general, OSHA does not expect
significant changes in the chemicals
covered by the HCS under the proposed
revisions as compared to the current
standard. The scope of hazards covered
by the GHS is very similar to what is
covered by the current HCS. Additional
chemicals may be considered to be
acutely toxic due to the proposed
adoption of Category 4 in acute toxicity
which would expand the criteria for
inclusion from the current definition
(see the discussion under ‘‘Hazard
classification’’). However, these
chemicals are already covered under the
voluntary national industry consensus
standard on precautionary labeling of
industrial chemicals (ANSI Z129) that
many manufacturers follow in their
labeling programs, as well as being
covered in the requirements that apply
to chemicals shipped to the EU. Thus
many manufacturers are already
classifying and labeling these chemicals
as acute toxins. The proposal is also
likely to cover fewer mixtures as acute
toxins than the current rule given the
hazard classification approach in the
GHS that uses a calculation based on
proportionality to determine whether a
mixture is covered, rather than a strict
percentage cut-off of 1%. Other
definitions of health hazards would
maintain the current broad HCS scope.
In addition to the overall scope
statement, the HCS provides for limited
coverage in workplace situations that
have special circumstances, including
laboratories and work operations where
employees only handle chemicals in
closed containers.
OSHA also addresses the interface
with other Federal agency requirements
by either exempting the products
covered from additional OSHA labeling
(such as pesticides required to be
labeled by the EPA), or completely
exempting the product (such as
hazardous waste regulated by EPA).
These accommodations help to ensure
that Federal requirements do not
conflict or duplicate each other.
Under the GHS, such provisions are
left under the purview of the
‘‘competent authority’’. In developing
the GHS, it was recognized that
countries’ regulatory authorities would
need to have the discretion to address
such national circumstances in ways
that are suited to the regulatory
perspective of the country. Thus
authorities such as OSHA are free to
make determinations about scope and
application issues while still being
harmonized with the primary provisions
of the GHS.
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OSHA has reviewed the current
provisions of paragraph (b), and has
determined that no significant changes
are required to be consistent with the
GHS. Several minor changes to revise
terminology are proposed (involving the
terms ‘‘classifying’’ and ‘‘safety data
sheets’’), but OSHA is not proposing to
modify any of the remaining provisions
of paragraph (b). The Agency is also
deleting Appendix E of the current HCS,
which was guidance for application of
the standard, and thus is deleting the
reference to it in paragraph (b)(1). As is
discussed elsewhere in this preamble,
new outreach and compliance
assistance materials are being prepared
to replace this appendix and other
existing outreach materials.
Several commenters indicated that
OSHA should adopt exemptions
included by the European Union in its
requirements. Specifically, these
exemptions address non-isolated
intermediates, chemicals involved in
research and development, and waste
(Document ID #s 0049, 0134, and 0164).
All of these situations are already
addressed in paragraph (b), and OSHA
does not believe it is necessary to
change them.
In terms of non-isolated
intermediates, the overall scope
provision in paragraph (b)(2) adequately
addresses this situation. This was
specifically addressed in the preamble
to the 1983 final rule (48 FR 53335):
That is, the term ‘‘known’’ means the
employer need not analyze intermediate
process streams, for example, to determine
the presence or quantity of trace
contaminants. However, where the employer
knows of such contaminants, and they are
hazardous, then they fall under the
provisions of the standard.
With regard to chemicals involved in
research and development, paragraph
(b)(3) limits coverage in laboratories,
and partially addresses this situation.
Where there is no knowledge of the
hazards of such chemicals, the HCS
does not apply at all since there is no
requirement to generate new hazard
information. Where information is
available, it must be provided to
exposed employees, consistent with
paragraph (b)(3) when it is in a
laboratory situation. Therefore, it
appears to OSHA that this situation is
also adequately addressed under the
current provisions. Hazardous waste as
regulated by EPA is already exempted
under paragraphs (b)(6)(i) and (ii).
There were commenters who
suggested that OSHA maintain current
exemptions or limitations in the revised
GHS, including the consumer product
exemption (Document ID # 0064),
guidance on byproducts (Document ID #
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0064), the relative roles of
manufacturers and employers
(Document ID # 0064), and the article
exemption (Document ID # 0160).
OSHA agrees and all of these
accommodations remain the same in the
proposed revised rule. As indicated in
the ANPR, the Agency does not intend
to change those parts of the HCS that are
not affected by the GHS.
One commenter indicated that the
revised HCS should indicate that it does
not apply fully to State prison inmates
because the GHS information would
give them data that could be used
illegally, and perhaps lead to harm
(Document ID # 0069). Generally
speaking, State prison inmates are not
directly subject to Federal requirements
under OSHA, although such
requirements may be applied to them
under State laws or the provisions of
another Federal agency. This comment
regarding limitations needed for inmates
should be addressed in those
jurisdictions, but nothing in these
revisions would substantially change
the application of the HCS to them.
There were also a few comments
regarding the scope of the revised rule
in terms of provisions of the GHS that
affect the environment or transportation
(see, e.g., Document ID #s 0072 and
0179). As OSHA indicated in the ANPR,
it does not have the authority to require
information in these areas since they are
not directed to the protection of
employees under its jurisdiction.
However, OSHA does not prohibit this
type of information on labels or safety
data sheets, and is aware that it is often
included on labels and safety data
sheets currently developed to comply
with the HCS. OSHA expects that
chemical manufacturers will, in fact,
continue to voluntarily include such
data on their labels and safety data
sheets to meet the requests of their
domestic and international customers.
(c) Definitions. This paragraph in the
HCS includes the terminology used with
the corresponding definitions.
Comprehension of the appropriate
definitions is critical to understanding
the provisions of the standard. In some
cases, terms are defined somewhat
differently than when used in other
contexts, so familiarity with the
standard’s definitions is important.
In the proposed revisions, OSHA has
retained as many definitions as possible
from the current HCS. Changes are
proposed only when there is a new term
used that needs to be defined, or there
is a different definition in the GHS, and
consistency with the international
definition is needed for harmonization
purposes. As with the preceding
paragraphs, minor modifications have
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been proposed to ensure terminology is
appropriate—primarily the use of terms
related to classification and safety data
sheets.
One important difference between the
HCS and GHS in terminology involves
the use of the term ‘‘chemical.’’ The
HCS has used this term since it was
originally promulgated, and defines it to
include elements, chemical compounds,
and mixtures of elements and/or
compounds. It has been a convenient
way to describe the coverage of the rule.
The GHS, like some other international
standards, uses the terms ‘‘substance’’
and ‘‘mixture’’. OSHA has decided to
maintain a definition of ‘‘chemical’’ in
the revised standard, which minimizes
the number of terminology changes that
have to be made to the regulatory text,
as well as providing a shorthand way to
define the scope to include both
individual substances and mixtures of
substances. This term is used in the
body of the proposed regulatory text,
similar to the use of it in the current
HCS. However, the proposed
modifications also include definitions
for ‘‘substance’’ as well as ‘‘mixture’’ to
align with the GHS, and both of these
terms are used as well. In particular, in
the appendixes that are adopting GHS
language, the separate terms
‘‘substance’’ and ‘‘mixture’’ are used
consistent with the GHS.
‘‘Substance’’ means chemical
elements and their compounds in the
natural state or obtained by any
production process, including any
additive necessary to preserve the
stability of the product and any
impurities deriving from the process
used, but excluding any solvent which
may be separated without affecting the
stability of the substance or changing its
composition.
A ‘‘mixture’’ is defined as a
‘‘combination or a solution composed of
two or more substances in which they
do not react.’’ This is consistent with
the GHS definition—and while slightly
different than the definition in the
current HCS, means the same thing.
OSHA is also proposing to maintain
the term ‘‘hazardous chemical’’ as used
in the current standard (a chemical
which is a physical or health hazard),
except to add the term ‘‘classified’’ to
indicate how it is determined that it is
a physical or health hazard, and to add
the coverage of unclassified hazards as
those terms are defined in a new
definition explained below. This term
will be used throughout the standard to
indicate that the classification process is
completed, and the chemical
manufacturer has determined that the
chemical poses a hazard—either by
meeting the requirements for a physical
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or health hazard or by virtue of being
considered an unclassified hazard under
this section. Most of the substantive
requirements of the rule apply to
hazardous chemicals.
Another proposed modification to the
definitions paragraph is to move the
physical hazard definitions to an
appendix. In the current HCS, health
hazard definitions are addressed
specifically in Appendix A to the rule,
but the physical hazard definitions were
included in paragraph (c). In the
proposed revisions, health hazard
definitions will continue to be
addressed in Appendix A, but a new
Appendix B will address physical
hazards. Both of these appendixes will
be discussed below under the summary
and explanation of ‘‘Hazard
Classification.’’
As noted in Section III above, the
physical hazard definitions in the GHS
are drawn from the United Nations’
Recommendations on the Transport of
Dangerous Goods. Since DOT has
adopted this international approach, the
GHS definitions are substantially
harmonized with the U.S. requirements
for labeling of dangerous goods in
transport. All chemicals that are
shipped in the U.S. have already been
classified according to DOT’s physical
hazard definitions. This will reduce the
burdens associated with classifying
physical hazards under the revised HCS.
The primary differences involve
exceptions that make the definitions
more applicable to workplace situations
(for example, coverage of flammable
liquids that are currently defined as
combustible under the HCS). Modifying
the HCS to align with the GHS thus
serves the purpose of harmonizing many
of these definitions domestically, and
results in shippers only having to
classify their chemicals once for most
physical hazards.
OSHA is proposing to add a definition
for the term ‘‘classification’’ in order to
ensure that the meaning of this term is
clear. Consistent with the definition of
classification in the GHS, the proposed
definition of ‘‘classification’’ is ‘‘to
identify the relevant data regarding the
hazards of a chemical; review those data
to ascertain the hazards associated with
the chemical, and decide whether the
chemical will be classified as
hazardous, and the degree of hazard
where appropriate, by comparing the
data with the criteria for health and
physical hazards.’’ This definition is
very similar to the process of hazard
determination that is currently in the
HCS, with the exception of determining
the degree of hazard where appropriate.
This reflects the GHS approach of
having categories for each class of
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hazard. Under the current HCS, there
are some definitions that have categories
in a hazard class (e.g., acute toxicity,
flammability), but other definitions are
simply one category (e.g.,
carcinogenicity). The additional
breakdown in the GHS of classes into
categories that reflect different severities
or levels of effect will provide both
employers and employees with more
precise information to understand the
hazards, to consider when evaluating
workplace conditions to determine the
risks in the workplace, and to respond
to exposure incidents.
In addition to the definition of
classification, OSHA has proposed a
definition for ‘‘hazard class’’ and
‘‘hazard category’’ to further explain the
approach of breaking down the
hazardous effects into levels of severity.
A ‘‘hazard class’’ is defined as ‘‘the
nature of the physical or health hazards,
e.g., flammable solid, carcinogen, acute
oral toxicity.’’ The definition of ‘‘hazard
category’’ is ‘‘the division of criteria
within each hazard class, e.g., oral acute
toxicity and flammable liquids include
four hazard categories. These categories
compare hazard severity within a
hazard class and should not be taken as
a comparison of hazard categories
generally.’’ These definitions are also
taken from the GHS.
OSHA is proposing to modify the
term ‘‘health hazard’’ to reflect the
specific hazards defined in the GHS.
While the overall scope of what is
covered is expected to be essentially the
same as the current HCS, the hazards
may be identified slightly differently.
For example, the current HCS covers
reproductive toxicity as a target organ
effect, and includes all aspects of the
effect under that hazard. The GHS has
a separate definition for germ cell
mutagenicity, which is considered part
of reproductive toxicity in the current
HCS. The definition of ‘‘health hazard’’
is thus proposed to be ‘‘a chemical
which is classified as posing one of the
following hazardous effects: acute
toxicity (any route of exposure); skin
corrosion or irritation; serious eye
damage or eye irritation; respiratory or
skin sensitization; germ cell
mutagenicity; carcinogenicity;
reproductive toxicity; specific target
organ toxicity (single or repeated
exposure); or aspiration toxicity. The
criteria for determining whether a
chemical is classified as a health hazard
are detailed in Appendix A, Health
Hazard Criteria.’’
A revised definition of ‘‘physical
hazard’’ is also proposed to reflect the
physical hazards covered in the GHS.
While these are similar to the coverage
of the HCS, they are in some cases
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described somewhat differently. The
definition proposed for ‘‘physical
hazard’’ is ‘‘a chemical which is
classified as posing one of the following
hazardous effects: explosive; flammable
(gases, aerosols, liquids, or solids);
oxidizer (liquid, solid or gas); selfreactive; pyrophoric (liquid or solid);
self-heating; organic peroxide; corrosive
to metal; gas under pressure; or wateractivated flammable gas.’’ In addition,
the definition refers to Appendix B,
Physical Hazard Criteria, for details.
The definition of ‘‘label’’ in the GHS
is slightly different than what is
currently in the HCS, and OSHA is
proposing to modify the HCS to be
consistent. Thus the proposed definition
of ‘‘label’’ is ‘‘an appropriate group of
written, printed or graphic information
elements concerning a hazardous
chemical that is affixed to, printed on,
or attached to the immediate container
of a hazardous chemical, or to the
outside packaging.’’ The GHS label is
more specific than what is required in
HCS, and includes certain core
information that must be presented.
Thus a definition for ‘‘label elements’’ is
also proposed, and it would mean ‘‘the
specified pictogram, hazard statement,
signal word, and precautionary
statement for each hazard class and
category.’’ ‘‘Safety data sheet (SDS)’’ is
defined as ‘‘written or printed material
concerning a hazardous chemical which
is prepared in accordance with
paragraph (g) of this section.’’
Definitions for terms that describe
information required to be provided on
labels are also proposed to be added to
the HCS. These include ‘‘hazard
statement’’, ‘‘pictogram,’’
‘‘precautionary statement,’’ ‘‘product
identifier,’’ and ‘‘signal word.’’ These
proposed new definitions will help to
clarify the specific requirements for
labels under the revised HCS, and are
consistent with similar definitions in
the GHS.
‘‘Hazard statement’’ is ‘‘a statement
assigned to a hazard class and category
that describes the nature of the hazards
of a chemical, including, where
appropriate, the degree of hazard.’’ This
is essentially what is defined as a
hazard warning under the current rule.
An example of a hazard statement under
the GHS is: Causes serious eye damage.
These statements have been codified,
meaning that numbers have been
assigned to them. They are available in
all of the official languages of the United
Nations, and thus translation will not be
a problem when shipping to countries
using those languages. Having
standardized statements is expected to
facilitate translation into other
languages as well.
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‘‘Pictogram’’ means a ‘‘composition
that may include a symbol plus other
graphic elements, such as a border,
background pattern, or color, that is
intended to convey specific information
about the hazards of a chemical.’’ This
definition covers both pictograms in the
transport sector, and those in other
sectors covered by the GHS. The
pictograms are required as part of the
core information provided on a label to
describe the hazards of a chemical. The
workplace pictograms will be a black
symbol on a white background with a
red diamond border frame. Some
commenters noted that the frame should
be permitted to be black for domestic
shipments as allowed under the GHS
(see, e.g., Document ID #s 0032 and
0163). However, as described in Section
V of this preamble, there are clear
benefits associated with the use of the
red frame in terms of recognition and
comprehensibility. Thus OSHA is
proposing to only allow the red frame to
be used, whether the shipment is
domestic or international.
Under the GHS, a symbol is generally
assigned to each hazard class and
category. There are nine agreed symbols
under the GHS to convey the health,
physical and environmental hazards.
Eight of these symbols are proposed for
adoption in this rulemaking, the
exception being the environmental
symbol. Six of these symbols have been
used for many years in the international
transport requirements, so some
employees will already be familiar with
them.
The ‘‘precautionary statement’’ is ‘‘a
phrase that describes recommended
measures that should be taken to
minimize or prevent adverse effects
resulting from exposure to a hazardous
chemical or improper storage or
handling.’’ The precautionary
statements specified in Appendix C will
be required on containers under the
revised HCS. An example of a
precautionary statement is ‘‘wear
protective gloves.’’ The precautionary
statements in the GHS are assigned to
certain hazard classes and categories.
Precautionary statements have not
previously been required under the
HCS, although many chemical
manufacturers include them on their
labels for safe handling and use. These
statements are codified under the GHS,
meaning that numbers have been
assigned to them. The precautionary
statements in the GHS are not
harmonized like the hazard statements
are, and the regulatory authority is free
to use the statements in the GHS annex
or to use alternative statements when
adopting the current version of the GHS.
Using the GHS statements has the
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advantage of adopting statements that
have undergone expert review by the
Subcommittee, are assigned to the
appropriate hazard class and category,
and have been translated into six
languages. Work continues on them in
the Subcommittee to combine or edit
the precautionary statements to reduce
repetition and complexity of the label.
The precautionary statements may be
considered harmonized in the future.
Other countries are already using them
(e.g., in Europe). Since OSHA did not
previously require the use of
precautionary statements, and had no
such recommended statements to
provide, the Agency has decided to use
those currently in the GHS as the
mandatory requirements. This will
make it easier for compliance since
chemical manufacturers and importers
will not need to develop, maintain, and
translate precautionary statements on
their own. It will also help employees
since they will be seeing the same
language on labels regardless of the
supplier of the chemical. Such
standardization improves
comprehension, and thus the
effectiveness of the information
transmitted under the standard.
Container labels will also be required
to include a ‘‘product identifier.’’ The
proposed definition for this term is ‘‘the
name or number used for a hazardous
chemical on a label and in the SDS. It
provides a unique means by which the
user can identify the chemical. The
product identifier used shall permit
cross references to be made among the
required list of hazardous chemicals, the
label, and the SDS.’’ In other words, the
product identifier is essentially the
same as the ‘‘identity’’ under the current
HCS. The GHS allows competent
authorities for workplace requirements
to choose not to require specific
chemical identities of ingredients to be
listed on the label, as long as they are
on the SDS. This is the approach OSHA
currently uses in the HCS, and it has
been effective. OSHA will continue to
require chemical identities only on
SDSs, and has proposed a definition for
‘‘product identifier’’ that is consistent
with the current definition for
‘‘identity’’ to maintain this approach.
Another new concept being proposed
for HCS labels is inclusion of a ‘‘signal
word’’ to bring attention to the
hazardous effects, as well as to
contribute to the recognition of the
severity of the hazard. Signal words
have been used for many years in the
United States on consumer and
pesticide labels. The proposed
definition is ‘‘a word used to indicate
the relative level of severity of hazard
and alert the reader to a potential hazard
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on the label. The signal words used in
this section are ‘danger’ and ‘warning.’
‘Danger’ is used for the more severe
hazards, while ‘warning’ is used for the
less severe.’’
OSHA is proposing to add a definition
to the HCS for ‘‘unclassified’’ hazards.
As has been noted, the current HCS is
performance-oriented, and takes a very
broad approach to defining hazards
covered by the rule. The GHS is
similarly broad in approach, but
includes very specific definitions of
criteria to apply when determining
whether a chemical poses a physical or
health hazard. This specification
approach has significant benefits
associated with it, including providing
more guidance to help ensure a
consistent approach to determining
hazards. It also allows more information
to be developed that provides an
indication of the severity of effect.
In the ANPR, OSHA asked for
comment on whether these criteria are
sufficient to cover the hazards present
in the workplace. While the Agency
believes the scope of coverage is similar
between the two approaches, OSHA
wants to be sure that the new approach
is as comprehensive as the existing
standard. The primary hazard addressed
by respondents to this question was
combustible dust. As will be discussed
later in this preamble, OSHA has
proposed that the United Nations add
criteria for combustible dust to the GHS,
so this issue should be resolved in the
future by having the necessary criteria.
Another potential example is simple
asphyxiation. The only specific
reference to this effect in the GHS is in
the part of the SDS that covers hazards
that do not result in classification—
suffocation is listed as an example. The
definition of ‘‘unclassified hazard’’
could be used in this situation as well.
Alternatively OSHA is considering
proposing a definition and label
elements as discussed in the issues
section.
It is possible that there are other
hazards that may not yet be specifically
defined. The addition of the definition
for unclassified hazards is intended to
address these situations. Where a
classifier has identified evidence of a
hazard, but the evidence does not meet
the currently specified criteria for
hazards covered by the rule, the
definition for unclassified hazards will
capture those hazards to ensure that the
modified HCS is appropriately
protective, and covers all of the hazards
covered by the current rule. During the
negotiations for the GHS, U.S. industry
representatives often raised the issue of
ensuring that they could provide
additional hazard information in order
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to satisfy product liability laws in the
U.S. This was the rationale for allowing
such information to be included on
labels under supplementary
information, and on SDSs under Section
2. Addition of the definition of
‘‘unclassified hazards’’, and specific
recognition of the need to provide
information when such effects arise,
should help U.S. industry address its
product liability concerns as well as
protect exposed workers.
OSHA would require the chemicals
posing unclassified hazards to be treated
as hazardous chemicals under the rule.
The Agency anticipates that this
information would appear in Section 2
of the SDS (Hazard Identification)—the
GHS already identifies this as the
appropriate place in its guidance on the
contents of SDSs (A4.3.2.3, Other
hazards which do not result in
classification), and it is included in
Appendix D of this proposal as
unclassified hazard. In terms of labeling,
there would be no specified label
elements for chemicals that pose
unclassified hazards. The label for such
hazards must describe the hazardous
effects under supplementary
information on the label, as well as
provide any appropriate precautionary
information. OSHA also expects that
such hazards would be addressed in
worker training programs.
The Agency anticipates that there will
be relatively few situations where there
will be scientific evidence or data
indicating a hazard that is not currently
classified, but wants to ensure that this
information is captured and conveyed to
employers and employees. It appears
that it would also be appropriate to
establish a feedback mechanism so in
the future, classifiers can inform OSHA
of these situations where the current
criteria are insufficient, and the Agency
can then suggest to the United Nations
that appropriate criteria be developed
and added to the GHS. This is
consistent with the overall approach to
hazard classification in the GHS that
OSHA is proposing to adopt—that
specific criteria be provided to help
ensure that classification is appropriate,
and information transmittal is
consistent from company-to-company.
Therefore, the use of the definition of
unclassified hazard should be a
temporary situation for these hazards,
ensuring information is provided until
such time as the criteria are added to the
rule. OSHA is requesting additional
input on this approach in the issues
section.
OSHA is not proposing to revise the
other terms currently defined in the
HCS. In addition, the GHS includes a
number of definitions that did not
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appear to be necessary for inclusion in
the revised HCS and as a result have not
been addressed here.
(d) Hazard classification.
Hazard determination under the
current standard. Under the existing
HCS, chemical manufacturers and
importers are required to evaluate the
scientific data available regarding the
chemicals they produce or import, and
determine whether they are hazardous
within the meaning of the standard.
This requires a thorough search of the
scientific literature on both the health
and physical hazards that the chemical
may pose. The identified information
must be evaluated within the
parameters established in the standard
to determine whether the chemical is
considered to pose a hazard. Paragraph
(d), Hazard determination, provides the
regulatory approach for evaluation. This
is to be implemented using the
definitions provided in paragraph (c), as
well as in Appendix A, which provides
further elaboration on the nature and
breadth of health hazards covered.
Appendix B provides additional
requirements for identifying and
evaluating data regarding hazards. Both
of these appendixes are mandatory.
In order to ensure the broadest
dissemination of information, and to
reduce the number of situations where
conflicting determinations may be made
for the same chemical by different
suppliers, the HCS considers one study,
conducted according to established
scientific principles and producing a
statistically significant result consistent
with the definitions of hazard in the
standard, to be sufficient for a finding of
health hazard under the rule. See 29
CFR 1910.1200(d)(2) and Appendix B.
This approach was the broadest among
those systems that were used as the
basis for the development of the GHS.
Most of the definitions under the HCS
simply lead to a conclusion that the
chemical involved poses that hazard or
it does not. For example, a chemical
might be found to be a carcinogen under
the rule based on one study indicating
that it poses a carcinogenic effect. The
current standard does not generally
address the degree of severity of the
hazardous effect in most of the
definitions—so a chemical is either a
carcinogen, or it is not. However, while
a one study determination leads to
providing information about that
hazardous effect on a safety data sheet,
it may not lead to a hazard warning on
a label. The HCS requires such warnings
to be ‘‘appropriate’’, and there are
situations where the data do not support
warning about the hazard on the label
because of other negative studies or
information. See 29 CFR 1910 (f)(1)(ii).
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Thus there is consideration of the
weight of evidence when deciding what
to include on a label. Chemical
manufacturers and importers may also
review the weight of evidence in
preparing SDSs, and are permitted to
discuss negative evidence and other
constraints when reporting the
information. Under the current
standard, OSHA expects the hazard
evaluation process to go beyond simply
identifying one study, and includes a
complete evaluation of all of the
information available when determining
what information to transmit to users of
the chemical.
This hazard evaluation process is
consistent with product stewardship
processes that have evolved in the
chemical industry. (See, e.g., the
Responsible Care® program
implemented by chemical
manufacturers.) Under such processes,
chemical manufacturers develop and
maintain thorough knowledge of their
chemicals. This knowledge is critical to
the safe handling and use of the
chemicals in their own facilities, as well
as in their customers’ facilities. It is also
critical to handling product liability
concerns for their materials.
The HCS requires chemical
manufacturers to remain vigilant
regarding new information about their
chemicals, and to add significant new
information about hazards or protective
measures to their hazard
communication documents within three
months of learning about them. See 29
CFR 1910.1200(f)(11), (g)(5). This has
always been seen by OSHA as a more
rigorous, but essential, requirement than
some other countries’ provisions, which
only require these documents to be
reviewed every few years. It should be
noted that OSHA has not been enforcing
the current requirement to change labels
within three months of getting new
information. This stay on enforcement
began some years ago when the standard
was first promulgated, and involved
concerns about existing stockpiles of
chemicals and other related
information. OSHA is proposing to
reinstate the requirement and lift the
stay, making the updating period
consistent with that required for safety
data sheets, and invites comments on
this issue.
At the time the HCS was promulgated,
the standard’s provisions and approach
were quite novel, and there were
concerns that chemical manufacturers
and importers would need more
guidance regarding what chemicals to
consider hazardous. Thus OSHA
included provisions in the hazard
determination paragraph that
established certain chemicals as being
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hazardous. Chemical manufacturers and
importers still had to complete a hazard
evaluation and determination of what
hazards were posed, but for these
designated chemicals, there was no
decision to be made as to whether they
were hazardous or not. These chemicals
were considered to be a ‘‘floor’’ of
chemicals covered by the rule, and
included those for which OSHA has
permissible exposure limits in 29 CFR
part 1910, as well as those for which the
American Conference of Governmental
Industrial Hygienists (ACGIH) has
recommended Threshold Limit Values
(TLVs). In addition, given that
carcinogenicity was the most
controversial and difficult health effect
to address, OSHA indicated that at a
minimum, chemicals found to be
carcinogenic in the National Toxicology
Program’s Annual Report on
Carcinogens, or in monographs
published by the International Agency
for Research on Cancer, were to be
considered to be carcinogens in addition
to those regulated by OSHA as
carcinogens.
The existing HCS also includes
provisions regarding hazard
determinations for mixtures. 29 CFR
1910.1200(d)(5). Where such mixtures
have been tested to determine their
hazardous effects, the data on the
mixture as a whole is used. Where
testing has not been done, OSHA
promulgated an approach based on the
percentage of a hazardous chemical in a
mixture to determine if the mixture is
hazardous. Therefore, if a mixture
contains one percent or more of a
chemical determined to present a health
hazard, the mixture is assumed to have
the same effect. The one exception is
carcinogens—a mixture is considered to
be carcinogenic if it contains 0.1% or
more of a chemical found to be
carcinogenic.
In all cases, a mixture will still be
considered to be hazardous if there is
evidence that it poses a health risk
when the hazardous chemical is present
in concentrations below the cut-offs.
This was included to ensure that
chemicals that can have effects at very
low concentrations, such as sensitizers,
will be adequately addressed.
For physical hazards, the evaluator
must determine based on whatever
objective evidence is available whether
the hazardous effect is still possible in
smaller concentrations. This recognizes
that for physical effects, such a
determination may be made based on
factors such as dilution, and there are
readily available means to make an
appropriate assessment.
The approach in the existing HCS is
considered to be a self-classification
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system. In other words, the chemical
manufacturer or importer reviews the
available information, and makes the
determination as to whether the product
presents a potential hazardous effect.
This is different than some other
systems where the regulatory authority
makes the determination, and publishes
a list of hazardous chemicals that must
be used by the chemical manufacturer
or importer.
The hazard determination is to be
completed based on available
information. The HCS does not require
testing of chemicals to produce
information where it is not available.
The hazard determination approach
in the HCS recognizes that information
about chemicals changes, new
chemicals are introduced, others cease
to be used—in other words, the world
of chemicals in the workplace changes
constantly, and the standard is designed
to ensure that employees receive the
most up-to-date information available
regarding the chemicals to which they
are currently being exposed.
Employers who simply use chemicals,
rather than producing or importing
them, are permitted to rely on the
information received from their
suppliers. 29 CFR 1910.1200(d)(1). This
downstream flow of information
recognizes that the chemical
manufacturers and importers have
access to information about the
chemicals they sell that is not available
to those who only use them. It also
reduces duplication of effort by focusing
the hazard determination process at the
source, rather than having everyone
who uses a chemical trying to complete
such a process.
The HCS requires chemical
manufacturers and importers to
maintain a copy of the procedures they
follow to make hazard determinations.
29 CFR 1910.1200(d)(6). If OSHA finds
errors in a label or SDS, the chemical
manufacturer or importer that prepared
the document will be held responsible—
not the employer using the chemical.
The hazard determination procedures
in the HCS, including the definitions
and Appendixes A and B, have been in
place since the standard was
promulgated in 1983. Therefore, the
intent to design an approach that was
dynamic and would remain current
through changes in the workplace
appears to have been accomplished.
Hazard Classification under the GHS.
The challenge in negotiating an
international approach was to create a
system that did not require frequent
changes yet remained current and
protective, incorporating the best parts
of the approaches in the existing
systems. The GHS embodies an
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approach that is very similar to the
existing HCS in scope and concept, but
builds in additional details and
parameters to help to ensure
consistency worldwide. Like the HCS,
the GHS approach is based on a
downstream flow of information from
suppliers to users; self-classification;
use of available information with no
new testing; and a broad approach to
definitions of hazard. The GHS has
further refined the approach to include
addressing the degree of severity of the
hazardous effects by assigning
categories of hazard within hazard
classes; providing detailed scientific
approaches to evaluating the available
data to help ensure that multiple
evaluators produce similar results when
classifying hazards; and allowing a
broader use of available data by
establishing principles where data can
be extrapolated in situations regarding
mixtures. OSHA believes that these
additional provisions in the GHS
enhance employee protection in
addition to the benefits of having an
internationally harmonized approach
when preparing labels and SDSs.
To accommodate these refinements,
and improve protection for employees
exposed to chemicals in the U.S., OSHA
is proposing to modify the HCS as
follows. First, paragraph (d) would be
re-named ‘‘hazard classification’’ rather
than the current ‘‘hazard
determination.’’ This is to be consistent
with the approach and terminology used
in the GHS. Similarly, paragraph (d)(1)
would be modified to indicate that
chemical manufacturers and importers
would be required to:
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* * * [c]lassify their health and physical
hazards in accordance with this section. For
each chemical, the chemical manufacturer or
importer shall determine which hazard
classes, and the category of each class, that
apply to the chemical being classified.
Paragraph (d)(1) would continue to
allow employers to rely on information
received from suppliers.
Paragraph (d)(2) would be similarly
modified to use terminology regarding
classification. However, the paragraph
also includes modifications to address
the evaluation process, and the role of
testing. The paragraph specifically states
that evaluation of the hazards of
chemicals requires the evaluator to
‘‘identify and consider the full range of
available scientific literature and other
evidence concerning the potential
hazards.’’ This is consistent with the
current HCS, but re-emphasizes the
responsibility to fully characterize the
hazard of the chemicals. To clarify that
available evidence is to be used, new
paragraph (d)(2) specifically states that
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there is no requirement to test a
chemical to classify its hazards under
the modified provisions—just as there is
no such requirement under the current
HCS.
Proposed paragraph (d)(2) also refers
to Appendixes A and B for further
information on classification as in the
current standard. However, the
proposed Appendixes have been
completely changed from the current
text. New Appendix A would include
the criteria for classification of health
hazards, and new Appendix B would
include the criteria for classification of
physical hazards. These mandatory
appendixes would have to be used for
the hazard classification process under
the proposed revised standard.
Reference to these appendixes is also
included in new paragraph (d)(3), which
addresses mixtures. This proposed
paragraph re-emphasizes that chemical
manufacturers and importers must
follow the procedures in Appendixes A
and B to classify hazards for mixtures as
well as for individual chemicals. In
addition, this proposed paragraph
indicates that chemical manufacturers
or importers would maintain the overall
responsibility for the accuracy of their
hazard classifications for mixtures even
if they rely on ingredient information
received from a supplier.
During implementation of the current
HCS, OSHA allowed formulators of
chemicals to develop an SDS by simply
providing the SDSs for all the
ingredients rather than compiling a
specific SDS for the product. OSHA
does not believe that this practice is
widely pursued, but it would not be
permitted under the proposal. The
revisions to the approach to classifying
mixtures would not lend itself to such
a practice. Hazard classification requires
consideration and application of
bridging principles based on the
constituents, as well as the application
of a formula when there are multiple
ingredients with acute toxicity. These
approaches require the evaluator to
determine a classification for the
mixture as a whole. In addition, this
practice places more of a burden on the
user of the product to sort out the
relevant information for protection of
their employees. The formulator is in a
better position to assess the information
and provide what is needed to their
customers.
Under the current HCS, paragraph
(d)(6) requires chemical manufacturers,
importers, or employers performing
hazard determinations to keep a copy of
the procedures they follow in the hazard
determination process. This provision
has been deleted in the proposed
revisions because the hazard
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classification procedures have been
specified, and thus all evaluators are
following the same process.
Proposed paragraph (d) is thus much
shorter and less detailed than paragraph
(d) in the existing standard. This is
largely due to the approach in the GHS
to include the details regarding
classification in hazard-specific
discussions that address both the
individual chemical and that chemical
in mixtures. Given the volume of these
criteria, it appeared to OSHA that
presenting the relevant information in
mandatory appendixes was a more
efficient way to describe the criteria
than including it all in the primary text
of the standard. This is particularly true
for those many employers reading the
standard who do not have to perform
hazard classification—the proposed
revisions only apply to chemical
manufacturers and importers, unless an
employer chooses not to rely on
information received from them.
Appendix A, Health Hazards.
Proposed Appendix A begins with an
introduction that includes material
related to principles of classification
taken from Chapter 1 of the GHS. These
address both weight of the evidence,
and the approach to mixtures. The
remainder of Appendix A is taken from
Chapter 3 of the GHS on Health
Hazards. OSHA has included the
specific discussions of all of the health
hazards covered by the HCS in proposed
Appendix A, extracted from Chapter 3
of the GHS. Generally speaking, OSHA
has proposed the language from Chapter
3 regarding the criteria for classification
to minimize deviations from the GHS
approach. However, each of the hazard
discussions has been reviewed carefully
within the context of the HCS, and there
has been some editing by OSHA. This
has been primarily to shorten the
discussions where possible to delete any
portions that do not relate specifically to
the method of classification for either
individual substances or mixtures. Thus
OSHA has removed the decision logics
that are in the GHS from the proposed
criteria, and is considering including
them in a guidance document to be
made available at the time a final rule
is published. The hazard
communication portions of the criteria
chapters have also been removed since
all of this information is already
available in proposed Appendix C and
is thus duplicative. In addition, as
discussed further below, edits have been
made where OSHA has not proposed to
adopt all of the categories of a particular
hazard class.
The chapters on Skin Corrosion/
Irritation and Serious Eye Damage/
Irritation have been modified more
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extensively than the other chapters on
health hazards in the GHS. In these
chapters, the GHS leads the evaluator to
conduct additional testing on the
chemical when information is not
available. While the GHS does not
require such testing, the criteria for
these effects imply that it should be
conducted to complete an evaluation.
The HCS is based solely on available
information, and no testing is ever
required. Therefore, OSHA has modified
these chapters to eliminate any
references to additional testing, and
limit the evaluation to what is known
based on available information. It
should be noted that the UNSCEGHS
has initiated work to review these
chapters to edit them and make them
easier to follow. OSHA will be
participating in this activity.
Each proposed hazard class
discussion includes the criteria for
classifying a substance or a mixture.
Unlike the HCS, which defines acrossthe-board percentage cut-offs for all
hazard classes, the GHS employs a
tiered approach to classification. Like
the HCS, classification would be based
on test data for a mixture as a whole for
most hazard classes where it is
available. However, where it is not
available, but there are data on
ingredients and similar mixtures, the
GHS allows extrapolation or bridging of
data to classify a mixture. This allows
greater use of available data before
resorting to a percentage cut-off or
similar approach. Where such data are
not available, the criteria address how to
classify mixtures based on cut-offs
specific to that hazard. In the case of
acute toxicity, this includes calculations
based on the acute toxicity of each
ingredient in the mixture.
The tiered scheme is somewhat
different for certain hazard classes. As
described, usually the evaluation is
based first on test data available on the
complete mixture, followed by the
applicable bridging principles, and
lastly, cut-off values/concentration or
additivity. The criteria for Germ Cell
Mutagenicity, Carcinogenicity, and
Reproductive Toxicity take a different
approach by considering the cut-off
levels as the primary tier and allowing
the classification to be modified on a
case-by-case basis based on available
test data for the mixture as a whole.
This is related to the sensitivity of
available test methods to detect these
types of effects at small concentrations
in the mixture as a whole.
This may result in some mixtures that
are currently considered to pose a
particular hazard not being so classified
under the GHS. OSHA believes that the
protections of the GHS approach are
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appropriate, and that these changes will
not result in an inappropriate reduction
in protection. For example, if there is a
mixture that is 1% of an acutely toxic
material, regardless of the severity of
that effect, and it is diluted with 99%
water, the current HCS would require
that mixture to be considered acutely
toxic. Under the GHS, it is unlikely to
be considered as such—based on the
dilution effect of the water, the acute
toxicity is no longer a concern. Thus the
bridging principles under the GHS
allow for a more accurate assessment of
the potential harm of the mixture,
whereas the strict cut-off approach
under the current HCS may provide
hazard information in cases where the
exposure is minimal and the occurrence
of an adverse effect is unlikely. In the
example described, the presence of the
water in the mixture as used by the
workers reduces the potential for
exposure to the hazardous ingredient to
such a small amount that no effect is
expected to result. The GHS approach is
not as simple to apply as the current
HCS, but the resulting approximation of
the hazards of the mixture will be more
accurate.
There are several hazard classes in the
GHS that give competent authorities
such as OSHA a choice of concentration
limits to apply when classifying a
mixture containing ingredients that pose
these effects (e.g., reproductive toxicity,
sensitization, target organ effects).
OSHA is proposing to use the most
protective of the available concentration
limits for these hazard classes, and
require information to be provided on
labels and safety data sheets at
concentrations above 0.1%. Other
countries may choose to only provide
the information on SDSs when the
concentration is higher. These particular
health effects are among the most
significant to employees, and OSHA
believes the provision of information on
labels will help both employers and
employees ensure that appropriate
protective measures are followed.
In determining which categories to
propose to adopt, OSHA employed two
primary principles in reviewing them.
First, the Agency tried to maintain a
scope as consistent as possible with the
current scope of the HCS, in particular
to maintain the level of protection in
keeping with that principle established
to guide the harmonization process (see
Section III)(an approach specifically
supported by Document ID #s 0021,
0163, and 0170). Second, consistent
with comments received and discussed
previously in this preamble (e.g.,
Document ID #s 0104, 0128, 0155, and
0171), OSHA reviewed what major
trading partners of the U.S. have
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50393
indicated they are proposing to adopt—
in particular, the EU since they have
already adopted an approach. Where
possible, and appropriate in terms of
maintaining protections and an
appropriate scope for the workplace,
OSHA has sought to be consistent with
these other proposed approaches for the
workplace.
All of the health hazard classes in the
GHS have been proposed to be adopted
in the HCS. However, for acute toxicity,
OSHA is proposing to adopt Categories
1 through 4, but not 5. (See Appendix
A.1 for a detailed explanation of acute
toxicity categories and their
corresponding cut-offs.) The current
coverage of the HCS is greater than
Category 3 of the GHS, but does not
include all of Category 4. If OSHA were
to adopt only 3 categories, it would
reduce protections with regard to acute
toxicity. Adopting Category 4 expands
coverage somewhat. However,
chemicals meeting the definition of
Category 4 are already covered under
the national consensus standard on
labeling that many chemical
manufacturers already follow (ANSI
Z129). In addition, those chemicals are
already covered by the EU under their
existing classification, packaging, and
labeling of dangerous substances
(Directive 67/548/EEC) and preparations
(Directive 1999/45/EC) directives, and
their adopted GHS provisions. These
countries comprise the largest trading
partner in chemicals for the U.S. Thus,
many manufacturers are already
classifying their chemicals as acutely
toxic to comply with European
requirements.
Coverage of Category 5 would not
only expand coverage significantly, it
would lead to inconsistency with
Europe and with the current national
consensus standard. OSHA also believes
that exposures of this magnitude are not
likely to be encountered in the
occupational setting, and that such
coverage would be excessive.
Since OSHA raised this issue for
comment, a number of respondents
specifically addressed acute toxicity.
The responses varied, although a
number supported the approach
proposed to cover through Category 4
(Document ID #s 0046, 0047, 0077,
0104, 0021, 0123, 0135, 0145, 0155,
0163, and 0171). For example, Dow
(Document ID # 0047) stated:
Dow believes that OSHA should adopt all
health hazard criteria and categories, except
Acute Toxicity Category 5. While this
category may be useful for characterizing
consumer products, its use with the
substances characterized under the HCS
would be confusing and unnecessary. Dow
understands that the EU and Australia have
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both chosen not to include Acute Toxicity
Category 5 in their implementation of the
GHS and that Canada is currently
considering doing the same. Dow believes
that the U.S. should be consistent with these
other major trading partners by not including
this category when it adopts the GHS.
Others suggested that OSHA propose
to adopt Categories 1 through 3
(Document ID #s 0054, 0034, 0128, and
0141). Some argued that all categories
should be adopted to ensure
harmonization (see, e.g., Document ID
#s 0050, 0078, 0106, 0018, 0036, and
0116).
As indicated, OSHA believes that
coverage of Categories 1 through 4 is
appropriately protective for the
workplace, and leads to the greatest
harmonization with workplace
authorities in other countries. With
regard to coverage of Category 5, OSHA
would not preclude inclusion of
information on Category 5 on the label
or the SDS when implementing the
proposed revisions. Thus chemical
manufacturers or importers who wish to
have one label that suffices for the
workplace and the consumer sector, for
example, could do that and still be in
compliance with the HCS.
While OSHA has chosen not to adopt
Category 5 for the reasons described,
and it does not appear in the Table
A.1.1, Paragraph A.1.3.6.1(a) requires
that the calculation of acute toxicity for
mixtures ‘‘[i]nclude ingredients with a
known acute toxicity, which fall into
any of the GHS acute toxicity
categories.’’ The intent of this provision
in the GHS was to include data on
substances classified as Category 5 in
the mixture calculation. The exclusion
of Category 5 from the text of the acute
toxicity table will likely mean that
classifiers could overlook substances
falling into this category in the mixtures
calculation, resulting in a higher (less
protective) classification. This could
also mean a lack of harmonization
within the U.S. if other Federal agencies
adopt Category 5, potentially requiring
inclusion of these data in the
calculation. The European Union GHS
system excluded Category 5 for all
sectors, and has explicitly excluded
Category 5 data from the mixture
calculation. OSHA invites comment on
whether Category 5 data should be
included in the calculation of the acute
toxicity of mixtures, and whether
exclusion of these data presents a
significant difference in hazard
classification.
OSHA is also not proposing to adopt
Category 3 for skin corrosion/irritation.
This particular category appears to
cover much more than the current
criteria for this hazardous effect under
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the HCS. In addition, the irritant effects
covered by Category 3 are very minor
and transient, and of limited
applicability in the workplace setting.
The Agency received several comments
supporting such an approach
(Document ID #s 0077, 0034, 0128,
0145, and 0171). This approach is also
consistent with the European Union.
OSHA has also not proposed to adopt
Category 2 for aspiration hazards
covered by the GHS. This category
appears to be more appropriate for the
consumer sector than the workplace.
OSHA does not specifically address
aspiration hazards in the current HCS
although the Agency believes the more
relevant and serious Category 1
aspiration hazards are captured under
the broad scope of the rule. Several
commenters suggested that Category 2
not be covered when aligning the HCS
with the GHS (Document ID #s 0077,
0034, 0128, 0145, and 0171), and the EU
does not include it in their
requirements. Others suggested that
aspiration should not be covered at all
since it is not relevant to the
occupational setting (Document ID #s
0102, 0104, and 0163). However, OSHA
believes that accidental aspiration is
possible in the occupational setting, and
thus has proposed to adopt the criteria
for Category 1.
Appendix B, Physical Hazards.
Appendix B includes the criteria for the
physical hazards proposed to be covered
by the HCS to be consistent with the
GHS. The current HCS covers these
hazards, but the definitions, while
similar, are not the same as those
included in the GHS. The GHS based its
physical hazard criteria on those
incorporated into the United Nations’
Recommendations on the Transport of
Dangerous Goods. In the U.S., the
Department of Transportation (DOT) has
already harmonized its definitions with
the UN, and thus, with few exceptions,
the GHS. While OSHA’s initial physical
hazard definitions were consistent with
the DOT definitions at the time the HCS
was promulgated, DOT’s harmonization
with the international requirements
resulted in the two agencies having
different definitions. Thus the U.S. has
not been domestically harmonized for
some years—adopting the same
definitions as DOT has in this
rulemaking will thus have the
additional benefit of accomplishing
substantial domestic harmonization.
As with Appendix A and the health
hazard criteria, OSHA has edited
Chapter 2 of the GHS to shorten the
discussions and focus only on the
criteria in the proposed revisions.
Decision logics and hazard
communication information are not
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included. OSHA is considering a
guidance document with the decision
logics to be made available when a final
rule is completed, and the hazard
communication information is already
in proposed Appendix C, so to include
it in Appendix A would be duplicative.
As with health hazards, OSHA is
trying to maintain the current scope of
the HCS for physical hazards in the
proposal, as well as being as consistent
as possible with trading partners,
particularly the European Union. One
exception may be flammable gases,
where it appears that more flammable
gases will be covered by OSHA adopting
Category 2 than are currently covered by
the HCS. OSHA is proposing to adopt
all of the physical hazards in the GHS.
The one deviation from the approach
adopted by the European Union is in the
proposed adoption of Categories 1
through 4 for flammable liquids. The
European system only addresses
Categories 1 through 3. Given the
current coverage of the HCS, not
covering Category 4 would be a
reduction of protection that OSHA does
not believe is appropriate. Thus we are
proposing to include coverage of
Category 4 in the HCS.
One edit that should be noted occurs
in the criteria for explosives. The GHS
criteria currently use the term ‘‘article’’
in a manner that is inconsistent with
that term as used in the workplace in
the U.S. OSHA has changed the term to
‘‘item’’ in these criteria.
While OSHA believes that
harmonizing with DOT provides
significant benefits, there are some
concerns regarding this approach that
have arisen in reviewing the physical
hazard criteria. These concerns involve
the test methods referred to in the GHS
criteria, which are based on issues
related to the packaging and volume in
transportation. Packaging is obviously a
major concern in transport, and is used
to address or mitigate the risk of
conveying certain types of chemicals.
These chemicals may or may not be
present in the workplace in the same
size or type of packaging and the
relevance of these factors in the test
methods are questionable in terms of
workplace exposures. OSHA invites
comment on this issue, both in terms of
the appropriateness of the criteria as
drawn (including the test methods and
references to packaging or volume), and
any suggestions that interested parties
have to address these issues. The
criteria of particular interest involve
those for self-reactive chemicals, organic
peroxides, self-heating chemicals, and
explosives.
OSHA raised as an issue for comment
in the ANPR the impact of changing
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some of the physical hazard criteria in
other OSHA standards that rely on HCS
definitions (for example, process safety
management). Many comments were
received on this issue (see, e.g.,
Document ID #s 0042, 0076, 0077, 0015,
0024, 0108, 0128, 0145, and 0163).
While opinions varied, generally the
consensus was that OSHA needed to
make the standards consistent.
OSHA has reviewed all of its other
standards, and the possible impact of
aligning the HCS with the GHS on those
rules. The Agency is proposing changes
to some of these other rules, and
discusses elsewhere in this preamble
the actions it has determined are
appropriate to address this issue.
Combustible dust. In the ANPR,
OSHA asked for comments on the scope
of health and physical hazards covered
by the HCS and the GHS. In response,
several commenters addressed the issue
of combustible dust. There is no specific
definition of combustible dust in the
HCS, nor is there one in the GHS. A
number of explosions have occurred in
workplaces due to an accumulation of
combustible dust. The U.S. Chemical
Safety and Hazard Investigation Board
(CSB) has investigated these explosions,
and made recommendations to OSHA
regarding a number of actions it should
undertake (Document ID # 0110). CSB
found that hazard communication
regarding such dusts was inadequate,
and is recommending the following
with regard to this rulemaking:
The CSB therefore recommends that OSHA
amend the HCS to explicitly address the fire
and explosion hazards of combustible dusts,
and those materials that could reasonably be
expected to produce combustible dusts,
among the substances covered by the
standard, and also that the Agency require
inclusion of dust fires and explosions among
the physical hazards that must be addressed
in Material Safety Data Sheets. The CSB also
requests that OSHA advocate similar changes
to the GHS through appropriate international
mechanisms.
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The Phylmar Group (Document ID #
0080) noted that combustible dust is not
specifically covered under the current
HCS, but suggested that it should be a
future revision to the GHS rather than
an addition to the HCS at this point:
Combustible dusts are not addressed in the
current HCS or the GHS. Although we
believe that combustible dusts should be
addressed in future revisions of the GHS, we
do not recommend that OSHA include them
in this rulemaking, as it would not achieve
the desired goal of global harmonization. We
encourage OSHA to work with the UN to
ensure that the hazards of combustible dusts
are addressed in the future.
The American Petroleum Institute
also suggested that OSHA discuss with
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the UN how to handle the classification
of explosive organic dusts (Document ID
# 0171). Both Dr. Michele Sullivan and
Organization Resources Counselors had
similar comments which highlighted the
hazards of combustible dusts, but
suggested that OSHA explore ways this
can be addressed on SDSs or in future
GHS revisions rather than suggesting
modification of the current HCS
(Document ID #s 0145 and 0123).
There are a number of activities
ongoing in OSHA regarding combustible
dust, including consideration of
additional standards or regulations
addressing this issue. Final decisions
have not been made regarding such
rulemaking. As noted by commenters,
the HCS does not include an explicit
definition of such dust. However,
manufacturers and importers are
required to perform a hazard evaluation
and consider all scientific evidence to
determine if their products present a
hazard. 29 CFR 1910.1200(d)(1) The
hazard determination must anticipate
the full range of downstream uses of a
product including any by-products that
may be generated during normal
conditions of use. It has been the
longstanding position of the Agency that
the hazard determination covers dusts
known to be subject to deflagration and
subsequent explosion, i.e., combustible
dusts. This information must be
conveyed on the MSDS.
Likewise, the GHS specifically
addresses inclusion of information on
the hazards associated with explosive
(combustible) dusts in the SDS. This
information would appear in Hazard
Identification (Section 2) on the SDS as
a hazard that does not result in
classification under the current
provisions of the GHS. This provision in
the GHS is consistent with OSHA’s
current coverage of combustible dusts
and is included in the proposed
modifications. In addition, as discussed
above, OSHA has added a definition for
unclassified hazards to the proposed
rule to address hazards such as
combustible dust that do not have
specific criteria for classification in the
current provisions. Under this
definition, combustible dust would be
covered as other hazardous chemicals
are, including information on labels,
SDSs, and in training.
Additionally, the United States has
submitted a working paper to propose
that the UN Subcommittee add
combustible dusts to their program of
work, and has volunteered to lead this
work. At such time as specific
classification criteria for combustible
dusts are added to the GHS, OSHA
would also add them to the modified
HCS. At this point, there are no agreed
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U.S. criteria to propose to the UN
Subcommittee. OSHA invites comments
on this issue, and specifically would
like to learn what stakeholders believe
would be an appropriate definition for
combustible dust to add to the GHS as
a physical hazard.
Other comments related to hazard
determination/classification. A number
of commenters responded to OSHA’s
specific questions related to hazard
determination and classification, but
few commented generally on the
approach in the GHS and the HCS. The
Refractory Ceramic Fibers Coalition
provided a general discussion on hazard
determination, and reached the same
conclusion as OSHA regarding the
contrast in the approaches (Document
ID # 0030):
The GHS and HCS hazard determination/
classification are self-classification processes,
but the GHS process is more detailed and
allows for closer scrutiny of the strengths and
weaknesses of the available data. RCFC
supports the GHS approach. While the HCS
has a one positive study threshold, the GHS
provides for the one positive study issue in
the context of analysis of the weight of all of
the available evidence. In vitro studies are
treated specifically, and there is
consideration of whether a substance is not
bioavailable or is inextricably bound.
Professional/expert judgment is included,
human experience is taken into account, and
negative findings and data which refute
findings are considered.
As described above, the existing HCS
includes reference to several lists of
chemicals in the hazard determination
provisions that the Agency considers a
‘‘floor’’ of chemicals that are to be
considered hazardous under all
circumstances. The lists were also
referred to in the mixture provisions—
requiring mixtures to be covered when
components could exceed established or
recommended exposure limits even
when present in concentrations below
the mixture cut-offs. Inclusion of the
floor and the mixture provisions in the
revised rule were raised as an issue for
comment in the ANPR, and a number of
responses were received. Opinions on
these issues varied significantly.
A number of commenters thought the
revised rule should take the same
approach as the existing rule (see, e.g.,
Document ID #s 0044, 0057, 0078, 0021,
0029, 0116, and 0149). On the other
hand, some respondents did not support
the inclusion of any additional lists, and
several noted that the GHS does not
include such an approach, and thus the
revised rule should not either since it is
being aligned with the GHS (see, e.g.,
Document ID #s 0046, 0047, 0049, 0058,
0064, 0036, 0107, 0123, and 0171).
Others objected to the process by which
TLVs are determined and/or suggested
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that it is not legal for OSHA to refer to
TLVs (Document ID #s 0064, 0083,
0100, 0101, 0111, 0132, and 0141).
As OSHA noted in the ANPR, the
more detailed hazard classification
provisions in the GHS preclude the
need for a floor and for the mixture
provisions related to exposure limits.
The current HCS does not provide a
specific and detailed approach to hazard
determination or classification of
hazards, and thus there was concern
during its promulgation about the
relative ability of chemical
manufacturers and importers to follow a
performance-oriented approach and
reach the same conclusions. The floor of
chemicals, as well as the mixture
provisions, reflected this concern by
providing additional guidance regarding
the types of chemicals that would be
considered hazardous were an
appropriate hazard determination
conducted. The proposed modifications
provide a specific and detailed
approach, and thus this additional
guidance is no longer necessary or
appropriate. OSHA believes that the
detailed and specific criteria would
provide equal or improved protection
for exposed employees since they would
improve consistency in evaluations, as
well as help to ensure a thorough and
comprehensive classification. In
addition, as noted by some commenters,
the GHS itself does not include such
lists, so including them in the revised
HCS would be a deviation from the
harmonized approach. Such a deviation
would detract from the benefits of
adopting a harmonized approach.
OSHA has thus decided to delete
references to any lists in the hazard
classification provisions being
proposed. The Agency believes that the
proposed revised criteria accomplish a
similar purpose in ensuring a
consistency in approach to classification
by various manufacturers of the same
product, and does not think these
provisions are needed in the proposed
standard for this purpose. Furthermore,
the GHS does not include a floor list of
this type, and maintaining such
provisions in the proposed revisions
would be a significant deviation from
the harmonized approach.
A few commenters argued that the
hazard classification approach in the
GHS would result in chemical
manufacturers testing or re-testing their
products (Document ID #s 0061, 0178,
0022, and 0141). If manufacturers
choose to test or re-test their products,
it will not be a result of either the
provisions of the GHS or those proposed
for the revised HCS. The GHS does not
require testing, and neither does the
HCS. Both are based on available data.
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This has always been the case for the
HCS, and is now explicitly addressed in
the revised text to ensure it is
understood by all stakeholders.
There were some other comments that
noted concerns about the effects of the
classification criteria on a specific
chemical or product, or which noted the
potential for a change in classification
or the need for additional guidance or
interpretation. Since OSHA had not
actually proposed language or coverage
for the rule in the ANPR, some of these
concerns were based on assumptions
about what requirements would be
included in a revised HCS and thus
should be re-considered in the context
of this proposal. As noted in the
discussion on outreach and compliance
assistance, OSHA is open to suggestions
regarding areas where help will be
needed, and classification has already
been highlighted as an area of concern.
One interesting comment that was
submitted by a number of respondents
involved development of a classification
data base (Document ID #s 0047, 0050,
0053, 0054, 0038, 0155, 0160, and
0165). Opinions as to who would
develop and maintain such a data base
varied (OSHA, U.S. industry, and an
international body were all mentioned).
During the development of the GHS,
chemical industry representatives did
not generally support inclusion of such
a list or data base of classified
chemicals. It appears that the European
Union will be making such a data base
available for compliance with its
requirements, as have Japan, Taiwan,
Korea, and New Zealand. Concerns are
now being raised by stakeholders that
classifications in these data bases are
different for the same chemical.
Development and maintenance of
such a data base would be a significant
undertaking for any entity, although the
appeal of such an approach is obvious.
The appearance of differing
classifications in national data bases is
certainly a concern. One development
that impacts this issue is that the
International Chemical Safety Cards
distributed by the International Program
on Chemical Safety are being updated to
be consistent with the GHS, and will
thus have classifications for over one
thousand commodity chemicals. Several
hundred have already been completed.
NIOSH represents the U.S. in this
activity (Document ID # 0082), and the
cards are available on their Web site
(which is linked on OSHA’s Web site).
These cards are available in multiple
languages, and are internationally
developed and peer reviewed. Thus
they will provide a data base on an
international level for a core group of
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widely available chemicals when the
update is completed.
The issue of a data base is one which
needs to be explored more fully, and the
logistics and implications studied. It has
been raised as an issue for consideration
by the UN Subcommittee as well. OSHA
invites further comment on how such an
approach might be further developed.
(e) Written hazard communication
program. The GHS does not include
provisions for a written hazard
communication program. Thus the
provisions of this paragraph are not
directly affected by implementation of
the GHS. The only changes proposed
align terminology, i.e., the proposal uses
the term ‘‘safety data sheet’’ rather than
‘‘material safety data sheet.’’
The written hazard communication
program requirements are intended to
ensure that the approach to hazard
communication in a given workplace is
coordinated and comprehensive. The
program includes a list of the hazardous
chemicals known to be present in the
workplace. This list is basically an
inventory of the chemicals the employer
must have safety data sheets for—and is
accessible to employees so they, too, can
determine what chemicals should be
included under the hazard
communication programs in their
workplace. The list can be maintained
by work area or for the workplace as a
whole, and can be kept by the
‘‘identity’’ of the chemicals (which
would be the product identifier under
the proposed rule). In other words, the
inventory can be common names or
product names, rather than individual
chemical ingredients of each product by
specific chemical identity or chemical
name.
In addition to the list, the HCS
requires the employer’s program to set
forth how hazard communication will
be implemented in the workplace. This
includes how the standard’s
requirements for labels, SDSs, and
training will be met; how the hazards of
non-routine tasks will be addressed; and
how hazard communication will be
handled in a multi-employer workplace
situation. OSHA has provided guidance
over the years on completing a written
program, and there are many sample
programs in circulation. The program
need not be lengthy or complicated, but
should have enough detail to provide
the reader with a blueprint of the
workplace-specific program.
Several comments were received from
the Small Business Administration
(SBA) and others that suggested there
would be significant burdens associated
with revising the written program as a
result of implementing the GHS (see,
e.g., Document ID #s 0022, 0027, 0111,
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and 0164). Revising the chemical
inventory was cited by these
commenters as one aspect that was
likely to be burdensome. Since the
chemical inventory is basically a list of
the products an employer has in the
workplace that are considered
hazardous, the only way this list would
change as a result of implementing the
GHS would be if something that was not
hazardous before is now, or vice versa.
OSHA believes that this is not a
significant concern for three reasons.
First, it would be unusual for a chemical
to only have one hazardous effect
associated with it so that the overall
determination of hazard would be
affected by a change in classification in
one hazard class. Secondly, because
HCS currently covers hazardous
chemicals, unless the chemical is new,
it is highly probable that it is already
covered. Third, as discussed above in
relation to the scope paragraph, OSHA
does not believe that the scope of
hazards covered by the GHS, and thus
the proposal, is substantially different
than the current HCS.
The most likely differences resulting
from re-classification under the revised
standard is that a chemical would be
placed in a category under a hazard
class that does not currently include
categories. It may also be possible that
a chemical may fall into a different
category where there are already defined
categories (such as flammability).
Neither of these differences would
necessitate a change in the inventory.
With regard to other changes in the
program, it does not appear likely there
would be many, if any at all. Written
programs usually describe aspects such
as who in the organization is
responsible for implementing different
parts of the program, or the type of inplant labeling system used. The revised
HCS need not affect these aspects at all.
Therefore, OSHA does not believe that
extensive revisions would have to be
made to written programs, including the
inventory, under the proposal.
Suggestions have been made by SBA
and others for outreach products related
to the written program, particularly for
an online inventory tool (Document ID
#s 0022 and 0027). Given that the
inventory is a simple list, it does not
appear that anything other than a word
processing program would be required
to generate this part of the program so
OSHA is not certain what is being
suggested by these stakeholders. OSHA
does not believe that a tool that lists all
hazardous chemicals, and allows
employers to check off those they have
in their workplace, would be feasible
given the extensive number of products
currently in use in American
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workplaces. Therefore, if this is what is
being suggested, it is not likely to be
provided.
OSHA is thus not proposing any
substantive modifications to the written
hazard communication program, and
does not anticipate any significant new
burdens associated with revising the
program as a result of other
modifications being proposed.
(f) Labels and other forms of warning.
The HCS is designed to provide
information through three different
media: labels or other forms of
immediate warning; safety data sheets;
and training. Labels are attached to the
container of chemicals, and thus
provide the information that employees
have the most ready access to in the
workplace. Given that they are attached
to containers, they are by necessity
somewhat limited in the amount of
information they can present. The labels
thus provide a snapshot or brief
summary of the more detailed
information provided to employees in
training programs, or available to them
on safety data sheets. They are not
intended to be a complete or detailed
source of information on the chemical.
In the current HCS, the requirements
for labels are performance-oriented. At
the time the standard was promulgated,
there were many different types of
labels in use. A common label format
used by industry was that provided by
the ANSI Z129, Hazardous Industrial
Chemicals—Precautionary Labeling
standard. Employers following this
format at the time provided a number of
different types of information on the
chemicals involved. However, there
were two areas where employers were
inconsistent or did not necessarily
provide what was needed when
following the national consensus
standard. The first was provision of an
identity on the label that could lead a
chemical user to the specific chemical
identities for the hazardous ingredients.
It was common practice to provide a
trade name for a product, but not the
names of ingredients, on either the label
or the safety data sheet. The second was
provision of specific information on the
hazards involved, such as the target
organ affected.
The current HCS label provisions
focus on this typically missing
information. On shipped containers,
chemical manufacturers or importers are
required to include an identity, and
appropriate hazard warnings, as well as
their name and address or that of a
responsible party. The term ‘‘identity’’
is defined in the HCS definitions
paragraph (c) as ‘‘any chemical or
common name which is indicated on
the material safety data sheet (MSDS)
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for the chemical. The identity used shall
permit cross-references to be made
among the required list of hazardous
chemicals, the label and the MSDS.’’
The hazard warning is to provide
specific information about the health or
physical hazards posed by the chemical.
The term is defined as ‘‘any words,
pictures, symbols, or combination
thereof appearing on a label or other
appropriate form of warning which
convey the specific physical and health
hazard(s), including target organ effects,
of the chemical(s) in the container(s).
(See the definitions for ‘physical hazard’
and ‘health hazard’ to determine the
hazards which must be covered.)’’
Similarly, the requirements for inplant containers specify an identity and
appropriate hazard warning. OSHA has
taken a flexible approach to in-plant
labeling, allowing a wide variety of
systems to be used as long as all of the
required information is readily available
to employees when they are in their
work areas. Thus employers were able
to continue using existing systems such
as the Hazardous Materials Information
System (HMIS) and the National Fire
Protection Association (NFPA) labeling
systems that use numerical rankings of
hazard.
The labeling provisions of the current
HCS exemplify the overall performance
orientation of the rule. They establish
the basic information requirements for
chemical manufacturers and importers,
but do not specify a format, or any
particular label elements to be used. As
a result, labels are often quite different
when the same chemical is addressed by
different suppliers, creating the
potential for employee confusion. While
many manufacturers follow the ANSI
national consensus standard, others do
not. Large manufacturers have
frequently developed their own libraries
or repositories of standard phrases, with
decision logics for when to apply them
to convey a hazard or a precaution.
Therefore, not only does this approach
lead to labels that are different, it also
results in a large duplication of effort by
chemical manufacturers developing
their own systems.
This performance-oriented approach
also did not lend itself to
harmonization. Other countries often
use more specific approaches, including
assignment of standard phrases to
certain hazardous effects, symbols, and
other label elements. It was clear that
the performance orientation of HCS,
with its many acceptable varieties of
labels, could not be standardized
through agreement on content to
achieve harmonization.
Given that a more specified approach
would also lead to consistency among
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manufacturers, as well as helping to
ensure the same message is received by
all exposed employees, OSHA agreed to
negotiate a harmonized approach that
was more specific than the current
standard. This was also agreed to by
stakeholder representatives involved in
the negotiations. Thus once a chemical
is classified as to its hazard classes and
corresponding categories, the GHS
specifies exactly what information is to
appear on a label for that chemical. As
described in Part V of this preamble,
OSHA believes that these specific
labeling requirements will be more
protective of employee health and safety
than the current performance-oriented
standard.
Paragraph (f) thus has more proposed
modifications than most of the other
paragraphs of the existing standard. The
title of paragraph (f)(1) has been
changed to indicate it addresses labels
on shipped containers. The required
information on these labels includes:
product identifier, signal word, hazard
statement(s), pictogram(s),
precautionary statement(s), and the
name, address and telephone number of
the chemical manufacturer, importer, or
other responsible party.
The proposal thus would require that
labels on shipped containers contain
much more information than under the
current standard. However, much of this
additional information has already been
included by manufacturers, particularly
when following the ANSI standard for
precautionary labeling. In addition, the
OSHA requirements are intended to be
the minimum information to be
provided by manufacturers and
importers. Under the GHS, as well as
the current HCS and the proposal,
chemical manufacturers and importers
are free to provide additional
information regarding the hazardous
chemical and precautions for safe
handling and use. The GHS and the
proposal refer to this as supplemental
information. Several commenters
requested that this be permitted
(Document ID #s 0132 and 0145).
Paragraph (f)(2) addresses labeling for
unclassified hazards. As noted
previously, the proposal ensures that
unclassified hazards (such as
combustible dusts and simple
asphyxiants) will continue to be covered
under the HCS. That means that hazard
information will have to appear on the
SDS, and in certain cases, the label. As
there are, however, no harmonized
labeling elements available for
unclassified hazards, the agency
requires the responsible party to
determine what information will be
included on the label. This evaluation is
to be based on the product’s hazards
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and exposures under normal conditions
of use and foreseeable emergencies.
Hazard information will be included on
the label, as appropriate, under
supplemental information, as well as
appropriate precautionary measures for
the safe handling and use of the
chemical.
Paragraph (f)(3) elaborates the label
requirements by stating that the
required information will be taken from
new Appendix C of the standard on
Allocation of Label Elements, which
incorporates the GHS labeling
requirements. This Appendix specifies
the signal word, hazard statement,
pictogram, and precautionary
statements for each hazard class and
category. It also includes a few basic
rules about preparing labels that address
precedence of hazards and other topics.
Thus once a hazard classification is
completed, the chemical manufacturer
or importer can refer to Appendix C to
determine what information must be
included on the label.
In addition to requiring that the
information be taken from Appendix C,
new paragraph (f)(4) also notes that the
harmonized information must be
located together on the label, tag, or
mark, prominently displayed, and in
English, although other languages may
also be included if appropriate.
The rest of paragraph (f) in the current
standard remains largely the same in the
proposed modified text, although
conforming changes to terminology are
made throughout the paragraph. The
current standard’s accommodation for
labels associated with solid metal is
maintained in the revised text, as is the
provision regarding conflicts with
requirements of the U.S. Department of
Transportation. In fact, since transport
rules have been harmonized with the
other sectors under the GHS, the
possibility of a conflict in information is
less likely when the HCS is consistent
with the international approach. Two
commenters specifically noted that
OSHA should avoid conflict with DOT
(Document ID #s 0064 and 0066). This
is already addressed in the standard
(currently paragraph (f)(3) and
contained in proposed paragraph (f)(6)).
They further noted that the exterior
package should be for displaying DOT
labels, rather than for OSHA labels. In
general, this would be true, although
there are some cases where the only
container serves as both the shipping
container and the workplace container,
such as drums. In these situations, there
are rules in the GHS regarding which
pictograms take precedence and the
ways in which to display the
information. These rules are in
Appendix C of this proposed rule.
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Under new paragraph (f)(7), OSHA
addresses workplace labeling in the
proposed text. As noted previously, the
current standard provides employers
with flexibility regarding the type of
system to be used in their workplaces.
Some comments suggested that OSHA
maintain this flexibility in the revised
standard (see, e.g., Document ID #s
0047, 0145, and 0157). OSHA agrees,
and the revised text maintains this
flexibility by indicating that the
employer can choose to label workplace
containers either with the same label
that would be on shipped containers for
the chemical under the revised rule, or
with label alternatives that meet the
requirements for the standard. It should
be noted that while alternatives are
permitted, the information must be
consistent with the revised HCS. Hazard
classifications must be revised as
necessary to conform, and the other
information provided must be revised to
ensure the appropriate message is
conveyed.
OSHA is not proposing to modify the
remaining paragraphs on labels in the
current HCS, including those that deal
with alternatives to affixing labels to
stationary containers; labeling of
portable containers where the materials
are transferred from a labeled container,
used within a workshift, and under the
control of the employee who performs
the transfer; ensuring that all containers
in the workplace have a label; a
requirement for workplace labels to be
in English and prominently displayed,
while allowing the information to be in
other languages as well; and the
requirement for updating label
information when there is new and
significant information regarding the
hazards of a chemical.
Several comments raised an issue
regarding potential confusion resulting
from the numbering of hazard categories
in the GHS (see, e.g., Document ID #s
0046, 0054, 0064, 0035, 0123, and
0146). As described in the GHS text,
some of the hazard classes that are
divided into categories use numbers to
designate those categories. Chemicals
posing the most serious hazards are
assigned to Category 1, and higher
category numbers denote less serious
hazards. Labels prepared under the
Hazardous Materials Information
System (HMIS) and National Fire
Protection Association (NFPA) systems,
on the other hand, use higher numbers
to indicate more severe hazards. It was
argued that the different approaches
would result in confusion and lead to
hazardous conditions in the workplace.
OSHA recognizes that the approach to
numbering hazard categories in the GHS
differs from that used in the HMIS and
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NFPA systems. However, the Agency
does not believe that this will result in
confusion. GHS category numbers
determine the label elements that would
be required for a chemical, but the
category numbers themselves would not
appear on labels. Where GHS category
numbers would appear on the SDS
(Section 2—Hazards identification),
they would be accompanied by the label
elements for the chemical, which would
clearly indicate the degree of hazard.
OSHA, therefore, does not anticipate
that this information will cause
employees to become confused.
Moreover, the approach taken in the
GHS (i.e., assigning higher category
numbers to denote less serious hazards)
is consistent with the approach used in
the DOT transport regulations for many
years.
A few commenters also argued that a
small package exemption, or some type
of prioritization of information on small
packages, should be permitted
(Document ID #s 0043, 0046, and 0080).
The current HCS does not have such an
exemption or limitation, but the Agency
has allowed practical accommodations
in those situations where an issue has
occurred. In Revision 3 of the GHS,
some provisions regarding small
package labels have been included
(1.4.10.5.4.4, Labelling of small
packagings). The competent authority is
given the discretion to implement
changes that allow label preparers to
reduce the required information to
accommodate a small package size.
OSHA is not proposing to adopt such a
provision, and intends to continue its
current approach regarding small
packages. Very small packagings are less
frequent in the workplace than in
consumer settings, and it is difficult to
argue that employees should get less
information just because of the size of
the package. The practical
accommodation approach OSHA has
been utilizing addresses those situations
where there is a valid issue, and ensures
that workers receive all of the required
information.
Some comments addressed objections
to the specific labeling requirements for
certain chemicals. For example, the
National Propane Gas Association
(Document ID # 0068) objected to
labeling propane as being ‘‘extremely’’
flammable, stating that it is usually
simply addressed as ‘‘flammable’’ in the
U.S. In addition, The Fertilizer Institute
(Document ID # 0045) objected to
having the skull and crossbones on
labels for anhydrous ammonia, stating
that use of it in fertilizers is necessary
for the food supply. Similarly, an
argument is made by the Styrene
Information and Research Center
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(Document ID # 0164) that no GHS
Category 2 carcinogens should be
labeled because it would result in more
chemicals being classified as
carcinogens than would be under the
International Agency for Research on
Cancer (IARC) criteria.
Adoption of the GHS is likely to result
in a number of situations where current
labeling practices are somewhat
changed by the introduction of the
concept of severity of hazard, and the
use of different label elements to convey
information. OSHA does not believe
that it would be appropriate to designate
substance-specific exemptions from
classification for reasons unrelated to
communication of hazards. In the case
of propane, designating it as ‘‘extremely
flammable’’ is actually already done by
a number of manufacturers or
distributors in the U.S., so it is not
necessarily a departure from current
practice. In addition, NPGA’s argument
that many propane distributors are
small businesses who don’t participate
in international trade (Document ID #
0068), is not related to improving and
enhancing the communication of
hazards to employees in the U.S.
Provision of an exemption for those
engaged solely in domestic commerce
would only increase employee
confusion about hazardous chemicals in
the workplace. Providing information
about the degree of hazard will help to
ensure that the material is handled with
the proper care needed to prevent
hazardous effects from occurring.
Similarly, the fact that anhydrous
ammonia is used for the food supply
ignores the significant hazards this
chemical poses to workers who handle
it. The skull and crossbones will
emphasize the degree of severity of the
hazard, as well as communicate the
hazard to individuals who do not read
or speak English—many of whom work
in the agriculture industry.
In addition, the mere fact that
incorporation of the GHS criteria might
change the number of chemicals
classified is not a reason to disregard the
carcinogens in Category 2. The IARC
criteria were one of the primary sources
used for development of the GHS
criteria, so it does not appear that there
is a significant difference in approach.
OSHA has had an enforcement
interpretation that would allow
manufacturers of certain carcinogens,
those in IARC Category IIB, to include
information about their carcinogenicity
on the safety data sheet but not the
label. Such an interpretation would not
be consistent with GHS, and is not
included in the proposed provisions.
Therefore, there may be some chemicals
that will now have carcinogen labels in
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50399
addition to SDS information as a result
of implementation of the GHS. This will
ensure that employees get consistent
information about these chemicals from
all suppliers. Furthermore, because the
current HCS uses the one study
criterion, it appears that more chemicals
are currently covered under the HCS
than under any other criteria applied.
A few comments were received
regarding EPA labels for pesticides,
noting that signal words in these labels
would change if GHS is adopted
(Document ID # 0178), and noting that
the requirements for these labels are
dictated by the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), and also control the SDS
content (Document ID # 0108). A
commenter also argued that pesticide
labels are more useful because they are
risk-based rather than hazard-based
(Document ID # 0108). OSHA believes
these concerns are not related to the
proposal. The revised HCS would
maintain the exemption for additional
labels on containers that are labeled in
accordance with EPA requirements. If
EPA decides to adopt the GHS, then
labels for pesticides would be consistent
with OSHA labels on other types of
products. With regard to SDSs, these are
required by the HCS, not FIFRA, and
therefore such SDSs must be consistent
with GHS provisions under these
proposed changes.
While the GHS specifies the
information to be placed on a label, it
does not provide a specific format for
placement, which is similar to current
HCS requirements. It was noted that
GHS does not specify a location or size
of core information on a shipment
(Document ID # 0066). OSHA believes
that this is best left in a performanceoriented provision, allowing
accommodations to be made as long as
the information is located together, and
is prominently displayed as required.
Other commenters noted that
changing labels will create confusion
and additional burden (Document ID #s
0065 and 0146); that there may be two
labels and SDSs during the transition
period, and that would be confusing
(Document ID # 0035); and that the
diamond shape of the pictogram was
similar to NFPA’s diamond, and
therefore confusing (Document ID #
0035). It is clear that a change in labels
will require a period of transition where
there may be some confusion, and there
will be two types of labels in the
workplace. However, when the GHS is
completely implemented, the current
widespread confusion resulting from
allowing multiple labeling approaches
will be eliminated. Comprehensibility
and effectiveness of hazard
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communication is expected to increase
as a result. OSHA believes these longterm benefits outweigh the short-term
transitional issues. As discussed above,
commenters in general recognized the
benefits of adoption of the GHS,
including enhancement of current
protections, and thus supported
pursuing this rulemaking. (See, e.g.,
Document ID#s 0046, 0047, 0054, 0059,
0064, 0081, 0034, 0038, 0158, and
0165).
There were a few commenters who
wanted additional elements in the
labeling system, such as the waterreactive pictogram so it could be posted
on buildings for fire authorities
(Document ID # 0029), and a numerical
ranking system similar to those
currently in use under voluntary
systems (Document ID # 0013). In the
case of the water-reactive pictogram,
there is certainly nothing in the current
HCS or in the GHS that precludes its use
to mark buildings, but that is a purpose
that is outside the scope of the system
at this point. In terms of the numerical
ranking system, the GHS was developed
based on consideration of existing
national and regional hazard
communication systems, and none of
those currently employ a numerical
ranking system. Thus, such an approach
was not considered in the process.
(g) Safety data sheets. The proposed
revisions to this paragraph are confined
primarily to paragraph (g)(2), other than
conforming terminology regarding
classification and SDSs. Paragraph (g)(2)
of the current HCS indicates what
information must be included on an
SDS. It does not specify a format for
presentation, or an order of information.
Chemical manufacturers and importers
have been free to use whatever format
they choose, as long as the information
is provided.
While this performance orientation
was supported by chemical
manufacturers when the standard was
originally promulgated, this was largely
based on those who were already
providing SDSs and did not want to
change their format. As the scope of the
standard was expanded to cover other
industries, it became clear that SDS
users preferred an order of information
or a format. In particular, stakeholders
such as emergency responders were
concerned that not being able to find
information in the same place on every
SDS could create an increased risk in
situations where the information was
needed quickly.
Several years after the HCS was
adopted, the chemical manufacturers
themselves responded to these concerns
by developing a national consensus
standard that included a 16-section SDS
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(ANSI Z400). The titles of each section
were established, as was the order of
presentation. The standard sought to
address concerns raised by also putting
information of most use to those
exposed in the beginning of the SDS,
with the more technical data required
by health and safety professionals in
later sections. They also responded to
comments that indicated the SDS
should be essentially ‘‘one stop
shopping’’ in terms of information on a
chemical, and should include other
information such as how it is regulated
by other Federal agencies, including
transport requirements and
environmental information.
In 1990, OSHA published a Request
for Information (RFI) that addressed the
issues of comprehensibility of labels
and SDSs (55 FR 20580). There were
nearly 600 comments received, and the
majority of respondents sought an order
of information or format for SDSs. Since
the international harmonization process
had begun at that point, OSHA thought
it would be useful to wait until a
globally harmonized SDS was available
before changing the requirements.
However, through interpretation, the
ANSI format has been acceptable for
many years, as long as the SDS includes
the required information (see CPL 2–
2.38D, the compliance directive for the
HCS). As explained in Section V of this
preamble, OSHA believes that the
implementation of a standardized SDS
format will enhance hazard
communication and be more protective
of employee health than the current
performance-oriented standard.
The 16-section format continued to be
recognized in different countries and
organizations over the years, including
an International Labor Organization
(ILO) recommendation on chemical
safety, the European SDS requirements,
and an International Standards
Organization standard on SDSs. When
the GHS was developed, it was decided
that this 16-section format was already
a de facto international approach, so it
was adapted to be part of the GHS. One
small change was made to reverse
sections 2 and 3 to put hazard
information before the chemical names
of ingredients. This change has
subsequently been adopted by ANSI and
other groups to be consistent.
Since the 16-section SDS was
initiated in the U.S. by industry, many
companies have been using it. This will
reduce the impact of adopting the GHS
requirements since the major
changeover to that approach has already
been made by those companies. Others
who continued to use different formats
will need to change their SDSs to
conform. There is already software
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available in the 16-section format, and
it is expected that more tools will be
available as the effective dates for
compliance approach.
OSHA is proposing to modify
paragraph (g)(2) to establish the section
numbers and title headings of the
sections of the SDS to be consistent with
the GHS. Furthermore, a new Appendix
D is being added to the standard to
address safety data sheets, and it
indicates what information must be
included in each section.
As OSHA indicated in the ANPR,
there are several sections of the SDS that
address information that is outside the
Agency’s jurisdiction (see the list of
sections below). OSHA will not be
making these sections mandatory for
inclusion, nor will any enforcement
activity be directed to these sections.
However, inclusion of the sections in an
SDS is not precluded, and they have
been included in the text of the revised
standard so people will be aware that a
fully GHS-compliant SDS will have to
address those areas in addition to the
ones mandated by OSHA.
The revised SDS would require the
following sections:
Section 1. Identification
Section 2. Hazard(s) identification.
Section 3. Composition/Information on
ingredients.
Section 4. First-aid measures.
Section 5. Fire-fighting measures.
Section 6. Accidental release measures.
Section 7. Handling and storage.
Section 8. Exposure controls/personal
protection.
Section 9. Physical and chemical
properties.
Section 10. Stability and reactivity.
Section 11. Toxicological information.
Section 16. Other information, including
date of preparation of the last revision.
A note in the revised text addresses the
other sections that are not mandatory for
OSHA:
Section 12. Ecological information.
Section 13. Disposal considerations.
Section 14. Transport information.
Section 15. Regulatory information.
The remainder of the paragraph on
SDSs remains the same as the current
HCS. The proposal retains the current
HCS design, ensuring the downstream
flow of information from the chemical
manufacturer or importer to the
distributor and ultimately the employer.
Other provisions regarding completion
of all sections of the SDS; provisions for
complex mixtures; the requirement for
information to be accurate and reflect
the scientific evidence; the need to
update the SDS when new and
significant information is available;
maintenance of SDSs so they are
accessible to employees;
accommodations for situations where
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employees travel between workplaces
during a workshift; and access for
OSHA and NIOSH, remain as they are
in the current standard.
As was the case with labels, relatively
few comments were submitted in
response to the ANPR on the specific
provisions for SDSs in the GHS. Those
provisions are generally consistent with
the current HCS, with the exception of
the standardized approach described
above that OSHA is proposing to
include in the revised text.
Comments were received on inclusion
of exposure limits on SDSs, and a
number of different opinions were
expressed, particularly regarding TLVs
being required. Many commenters
argued that TLVs should be included on
the SDSs as currently required under
the HCS (see, e.g., Document ID #s 0042,
0179, 0021, 0038, 0124, and 0149).
Others suggested they should not be
required (see, e.g., Document ID #s
0058, 0064, 0036, 0129, 0151, and
0163). There were also a number of
commenters that suggested other types
of occupational exposure limits that
should be included on SDSs, such as
levels from other countries, those
recommended by NIOSH, and those
recommended by the American
Industrial Hygiene Association (see, e.g.,
0044, 0077, 0018, 0024, 0109, 0147, and
0171). OSHA has decided to maintain
the requirement to include its
mandatory permissible exposure limits
(PELs) on the SDSs, and to specify, as
in the existing HCS, that manufacturers
should include ‘‘any other exposure
limit used or recommended by the
chemical manufacturer, importer, or
employer preparing the safety data
sheet.’’ This will allow inclusion of any
of the different types of occupational
exposure limits commenters
recommended for inclusion where the
SDS preparer deems it appropriate. It
also helps to minimize differences
between the U.S. and other countries by
not providing (except for PELs) a list of
U.S.-specific occupational exposure
limits that must be included, yet
provides protection for employees by
allowing inclusion of various
recommendations that will help
employers design appropriate protective
measures.
Several commenters appear to believe
that the GHS requires disclosure of all
ingredients in a mixture, unlike the
current rule that has percentage cut-offs
(Document ID #s 0048, 0056, and 0064),
and argue that the current rule’s
approach should be maintained. In fact,
the GHS approaches ingredient
disclosure in a manner consistent with
the current HCS, although the cut-offs
may be different for the various health
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hazards covered. Similarly, it was
suggested that there be a de minimis
level below which SDSs would not be
required (Document ID # 0178). This is
already addressed by the cut-offs in the
mixture classification provisions for
each health hazard class. It was
suggested that the GHS approach to
ingredient disclosure would lead to
more testing of chemicals (Document ID
#s 0048 and 0056). This is not true as
neither the current HCS nor the GHS
require testing of any kind to be
performed.
A number of comments suggested
specific information to be included on
the SDS, such as the Chemical Abstracts
Service Registry Number (Document ID
# 0044); whether a chemical is an EPA
hazardous waste (Document ID # 0059
and 0108); control banding
recommendations (Document ID #
0081); lethal dose data (Document ID #
0015); a miscellaneous section
(Document ID # 0019); NFPA and HMIS
ratings (Document ID # 0019); storage
requirements (Document ID # 0019);
reference to the DOT Emergency
Response Guide (Document ID # 0019);
and more spill cleanup and disposal
information (Document ID # 0028).
Much of this information is already
included in the proposed SDS (such as
the CAS Registry Number and lethal
dose data). The other information noted
could certainly be included in the SDS
as additional information to that which
is required by OSHA. The information
referenced by these comments that falls
under sections of the SDS that are not
workplace-related (e.g., environmental
and transport information) cannot be
required by OSHA. The Agency would
certainly not preclude inclusion of such
information by SDS preparers
voluntarily, or as a result of
requirements at some time in the future
by the other Agencies that do have
responsibility for those subject areas.
Several commenters noted that SDSs
need to be written in plain language
(Document ID #s 0044, 0010, and 0035).
In general, the Agency agrees that SDSs
should be written as plainly as possible
while still conveying the required
information to the intended audiences.
As originally designed by ANSI, the
sections in the beginning of the SDS are
intended to be written in plain
language, with fewer technical terms
where possible. This information should
be of immediate use in emergency
situations for example. But many of the
remaining sections of the SDS require
technical information, and they are
intended to be of use primarily to
professionals designing protective
measures or providing services such as
medical surveillance to exposed
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50401
employees. These sections need to
retain their technical terminology in
order to be useful to the professionals
for these purposes.
A number of the comments received
dealt with the management of SDSs,
rather than the specific requirements for
preparing them. For example, one
commenter said that there would be a
large burden associated with sending
letters to obtain new SDSs, tracking
their receipt, and updating workplace
data bases (Document ID # 0178). The
proposal would employ the same
approach as the current HCS for
distribution of SDSs. During the phasein period for the standard, chemical
manufacturers, importers, and
distributors will be required to send a
new SDS with their next shipment of a
chemical to their customers. In other
words, employers should automatically
receive new SDSs, just as they do now
when an SDS is updated. There will still
be a burden associated with updating
workplace records, but since users are
not required to solicit new SDSs, there
will not be a burden of sending letters
to suppliers and tracking receipt of the
responses. Furthermore, the phase-in
period should be long enough that there
will be turnover of chemical supplies
that necessitate a new shipment in most
cases.
Several commenters suggested that an
online library of SDSs be created by
OSHA (Document ID #s 0019, 0028, and
0146). This is an approach that was
investigated by OSHA in the past, and
at that time, it was determined that it
would not be feasible for the Agency to
maintain a complete and up-to-date data
base of all the SDSs in use in American
workplaces. The number of SDSs
involved is very large, and there is no
way for the Agency to know about each
SDS or when each is updated. OSHA
believes this approach is still infeasible
for the Agency.
There appeared to be some concern
about having two SDSs for the same
product during the phase-in period, and
how an employer would decide which
takes precedence (Document ID # 0146).
OSHA believes that the most recent
version would be the one that takes
precedence, and should be maintained
in the workplace. It would not be
necessary to maintain two versions for
purposes of the proposed standard.
There was also a comment regarding
SDS management for construction sites,
and the use of a FAXback system
(Document ID # 0022). This is an issue
that has long been addressed by OSHA
in its compliance directive (CPL 2–
2.38D), as well as in the standard itself
(see paragraph (g)(8) of the existing
HCS), with provisions for what would
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be considered effective electronic access
to SDSs. The proposed revisions to the
rule do not change these requirements.
(h) Employee information and
training. The GHS does not include
harmonized training requirements, but
does recognize the important role that
training plays in hazard
communication. For example, 1.1.3.1.3
of the GHS states:
In the workplace, it is expected that all of
the GHS elements will be adopted, including
labels that have the harmonized core
information under the GHS, and safety data
sheets. It is also anticipated that this will be
supplemented by employee training to help
ensure effective communication.
OSHA agrees that training is key to
ensuring effective hazard
communication. Under the current HCS,
training is used to explain the label and
SDS systems used in a workplace, as
well as addressing the hazards of
chemicals and protective measures.
While the written information provided
is clearly important, training is an
opportunity to explain the data and
helps to ensure that the messages are
being received accurately so they can be
acted on appropriately. (See Section V
of this preamble.)
The training provisions in the HCS do
not need to be modified to be consistent
with the GHS since it does not include
such requirements. However, OSHA is
proposing small revisions to track
terminology used in other paragraphs,
as well as to clarify the requirement to
train on the details of the hazard
communication program in (h)(3)(iv).
While this has always been required in
the HCS, OSHA believes that modifying
the text slightly will convey the need to
address both the labels that will arrive
on shipped containers, as well as any
workplace-specific system that the
employer uses. In addition, the training
on SDSs must include the order of
information. So the revised text would
read:
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The details of the hazard communication
program developed by the employer,
including an explanation of the labels
received on shipped containers and the
workplace labeling system used by their
employer; the safety data sheets, including
the order of information and how employees
can obtain and use the appropriate hazard
information.
In addition, OSHA is proposing that
employers train or re-train employees
regarding the new labels and safety data
sheets within two years after the rule is
promulgated. The Agency believes that
the training needs to be completed by
the time employees begin to see labels
and safety data sheets with the new
information on them, rather than
waiting until after the transition has
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been completed. Comment is invited on
this approach.
Some commenters noted that training
would be required to ensure employees
understand, in particular, the symbols
and pictograms that will be used on
labels. Some argued that the burden
would be substantial given that all
training would have to be revised, and
the time and resources required would
be significant (see, e.g., Document ID #s
0178 and 0153). However, many agreed
that having a standardized approach to
labels and SDSs will make training
easier in the future than training under
the current rule where chemical
manufacturers and importers can use
whatever formats they choose (see, e.g.,
Document ID #s 0042, 0072, 0077, and
0030).
Marshfield Clinic (Document ID #
0028) noted that communication of
information about chemicals and other
hazardous substances:
* * *[I]s one of the more difficult to get
across to workers. It is very appreciated that
OSHA is revisiting this. Standardization will
greatly assist in giving workers a better
understanding of the hazards they may
encounter when working with chemicals and
other hazardous substances.
Similarly, Alcoa (Document ID #
0042) suggested that: ‘‘A standardized
format will simplify hazard
communication training and the use of
pictograms will alleviate some of the
problems presented by poor language
skills.’’
There were a few commenters who
argued that the standardized approach
either would not simplify training, or
they did not know if it would (see, e.g.,
Document ID #s 0065 and 0078).
Another noted that the current approach
is fine for companies that are domestic
only (Document ID # 0026).
There were also many comments
related to outreach that suggested
compliance assistance in the area of
employee training. As OSHA noted in
the ANPR, the Agency is considering
the development of generic training on
symbols to make available to employers
(71 FR 53624). OSHA has been working
with NIOSH to prepare training on
symbols and pictograms in particular
(addressed by NIOSH in their comment
at Document ID # 0082). However, it is
expected that there will be other
products related to training as well, both
from OSHA and from the private sector.
(i) Trade secrets. The current HCS
includes provisions that define what
can be considered trade secret
information under the rule, as well as
delineate the conditions under which
this information must be disclosed to
ensure the safety and health of exposed
employees. These provisions were a
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significant focus of the original
rulemaking on the HCS, and reflect the
common law of the United States on
this topic. In the years since the rule has
been in effect, however, this issue has
not been as important. Overall, since
these provisions were promulgated, it
appears that fewer claims of trade
secrecy have been made, and fewer
requests for trade secret disclosure have
been received, than were anticipated
during the rulemaking process.
The negotiations for development of
the GHS recognized at the outset that
trade secrets—generally referred to
internationally as confidential business
information—would be an issue of
concern. Guiding principles included
the following:
In relation to chemical hazard
communication, the safety and health of
workers, consumers and the public in
general, as well as the protection of the
environment, should be ensured while
protecting confidential business information,
as prescribed by the competent authorities.
As the issue was considered further,
it was recognized that laws regarding
confidential business information were
very much country-specific, and had a
broader context than rules for
classification and labeling. Such laws
could not be modified or harmonized
through the process of harmonizing
classification and labeling. Thus it was
determined that the GHS would
recognize the importance of the issue,
and provide principles for countries to
follow when adopting the provisions.
These principles are consistent with the
approach already incorporated into the
HCS.
First, the type of information that can
be considered confidential or trade
secret is limited to the names of
chemicals and their concentrations in
mixtures. Under the current HCS, OSHA
did not require that concentrations in
mixtures be disclosed, and thus limited
claims to specific chemical identities.
This is the primary difference between
the current rule and the proposed
revisions to HCS. To be consistent with
GHS, OSHA is proposing to add
percentage composition information to
the SDS. This introduces the possibility
that trade secret claims will be made for
this type of information, as well as
specific chemical identities. Thus the
proposal revises the text of the current
rule to add consideration of percentage
composition everywhere specific
chemical identity is addressed in the
provisions.
The GHS further suggests that SDSs
indicate when information has been
withheld as confidential; that the
information be disclosed to the
competent authority upon request and
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under condition of confidentiality; that
the information must be disclosed in a
medical emergency, with mechanisms
to protect it while ensuring timely
disclosure; that the information be
disclosed in non-emergency situations,
also under conditions of protecting
confidentiality; and that the competent
authority have procedures to deal with
challenges to this process. All of these
principles have already been included
in the trade secret provisions of the
HCS, and are maintained in the revised
rule as previously promulgated. The
proposed revisions simply conform
terminology, and add text regarding
percentage composition being subject to
the same provisions as specific chemical
identity.
Very few comments on trade secrets
or confidential business information
were received in response to the ANPR.
It was suggested that protection of
confidential business information
should be an implementation principle
for the GHS modifications to HCS
(Document ID #s 0072 and 0179), and
that the current trade secret position
should be retained (Document ID #
0049). There was also a comment that
indicated full disclosure of all
ingredients should be required on the
SDS unless the employer provides a
justification to the Agency showing that
a particular ingredient is a trade secret,
and demonstrating that the economic
damage of disclosure exceeds the
damage associated with the potential
health effects to exposed employees
(Document ID # 0044). In addition, the
National Paints and Coatings
Association (NPCA) argued that the
approaches to protection of confidential
business information need to be
harmonized (Document ID # 0050). As
NPCA noted, different approaches may
lead to development of different SDSs
for various authorities.
As noted above, laws regarding
confidential business information are
generally not specific to classification
and labeling requirements, but rather
reflect an overall approach of a country.
It was not possible to change such laws
through the harmonization of
classification and labeling, and thus the
limit of the agreement was to establish
the principles already described. Those
principles are consistent with law in the
United States, and do not require any
modifications to the current HCS
approach to be consistent with the GHS.
As implementation moves forward in
different countries and regions,
conformance to the GHS principles
should lead to increased harmonization
of approaches. This is an area that
should be monitored to determine if
further action can be defined and
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implemented. OSHA does not believe it
would be prudent to implement changes
in the approach to trade secret
protection and disclosure before that
time.
(j) Effective dates. OSHA is proposing
to require implementation of the
revisions to the HCS in 3 years after the
final rule is completed. Training would
be required two years after the final
rule, and all provisions would be
implemented in 3 years. During the
transition period, employers would be
required to be in compliance with either
the existing HCS or the modified GHS,
or both. OSHA recognizes that hazard
communication programs will go
through a period of time where labels
and safety data sheets under both
standards will be present in the
workplace. This will be considered
acceptable, and employers are not
required to maintain two sets of labels
or safety data sheets for compliance
purposes. However, given the
longstanding requirements for a hazard
communication program, there must be
no time during the transition period
when hazard communication is not in
effect in the workplace, and information
is not available under either the existing
requirements or the new final standard
for exposed employees.
Many comments were received on the
issue of phasing in the requirements of
the GHS, as well as on current practices
and time frames required for various
activities. There was a wide variety of
opinions, as well as a number of factors
that commenters suggested should be
considered in establishing effective
dates.
OSHA specifically requested input on
the possibility of phasing in
requirements based on the size of the
business. While a few commenters
supported this approach (see, e.g.,
Document ID #s 0022, 0144, 0146, and
0151), many more indicated that this
would not be appropriate (see, e.g.,
Document ID #s 0042, 0018, 0033, 0107,
0116, 0123, 0147, 0154, and 0171). One
reason given was that the supply chain
may involve large businesses
purchasing from small businesses, and
thus they would need information from
them in order to comply themselves
(Document ID #s 0080 and 0123).
There were also those who thought
the phasing should be coordinated with
other trading partners, particularly the
European Union (Document ID #s 0072,
0080, 0081, 0179, 0024, 0163, and
0171). The European phasing is taking
place over a long period of time because
of the REACH requirements for
chemicals that are going into effect. The
long time periods being considered do
not necessarily reflect a determination
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that the amount of time is needed just
for compliance with GHS. Another
suggestion that had support was to
phase in substances first, and then cover
mixtures, or to have a 3-step phase-in
that includes intermediates before
mixtures (see, e.g., Document ID #s
0104, 0021, 0024, 0034, 0036, 0122,
0141, and 0154).
A number of other phasing
approaches were also mentioned,
including selecting the 200 most
produced chemicals by weight and then
sort them by hazard (Document ID #
0139); examining the data available on
the chemicals in determining which to
do first (Document ID #s 0081 and
0036); basing it on the time to use up
stockpiles (Document ID # 0022); and
‘‘sufficient’’ time to work through the
supply chain (Document ID #s 0068 and
0122).
There were also suggestions for a
specific number of years, or a range of
years. Some of these suggested less than
3 years (see, e.g., Document ID #s 0064,
0019, and 0028). A number suggested 3
to 5 years, or in some cases, 6 years (see,
e.g., Document ID #s 0042, 0046, 0104,
0015, 0032, 0038, 0111, 0125, and
0163). And there were some
commenters who suggested anywhere
from 7 to 13 years for full compliance
(see, e.g., Document ID #s 0050, 0077,
0078, 0018, 0116, 0129, 0141, and
0164).
OSHA decided on the 3-year proposal
based on a consideration of the widely
diverse viewpoints expressed, as well as
information provided by commenters
about stockpiles and other issues. It is
clear that activities have already begun
by a number of vendors of software
programs for hazard classification and
labeling to convert to the GHS and make
programs available for companies to use
to comply with requirements around the
world as countries adopt the GHS. This
work is already underway, and by the
time this rulemaking is finalized, it is
expected that much of it will be
completed. And there were commenters
that indicated that work is already being
done in their companies to comply,
particularly those that are multinational.
(See Section VII for an analysis of
activities already underway.)
While the Agency wants to provide
sufficient time for compliance, there is
also a concern about the effect on
employees of dealing with multiple
systems during a transition period.
While some time period when the
currently required labels and the new
GHS labels will co-exist is inevitable,
the longer this period continues, the less
effective the communication to
employees will be. It is therefore
important to minimize the effects of the
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transition on the effectiveness of hazard
communication by ensuring that is
completed in a timely fashion, while
allowing adequate time for an orderly
changeover.
Requiring the phasing in of
substances first, and then mixtures,
clearly has some persuasive logic as an
approach. However, the supply chain is
not always orderly and logical. It cannot
be assumed, for example, that no
mixtures can be completed until all
substances are done. Mixtures that are
comprised of substances that are widely
available, and their hazards are well
known, do not need an extensive time
period to complete. Some mixtures are
comprised of other mixtures rather than
substances, and producers of such
mixtures will need information on the
component mixtures before they can
comply. Waiting till the end of an
extensive time period to complete their
work may not allow them to meet the
compliance dates. These types of issues
are generally addressed by the market,
and the needs of a manufacturer’s
customers, and cannot be individually
addressed in a phasing-in period.
Further comment on this issue would be
helpful to determine whether the final
rule should include such phasing by
type of product.
Other Standards Affected by the GHS
Modification to the HCS
OSHA has reviewed all its standards
and is proposing to modify standards in
General Industry (29 CFR part 1910),
Construction (29 CFR part 1926), and
Shipyards, Marine Terminals and
Longshoring (29 CFR parts 1915, 1917
and 1918) that contain hazard
classification and communication
provisions in order that they will be
internally consistent and aligned with
the GHS modifications to the HCS.
There is strong support in the record for
including these OSHA standards in this
rulemaking.
The issue of how to deal with OSHA’s
existing standards was raised in the
ANPR. (71 FR 53617; Sept. 12, 2006).
OSHA specifically requested input on
how GHS provisions addressing
classification of physical hazards such
as flammable liquids would impact
other OSHA standards. OSHA also
asked whether physical hazard
definitions in other standards should be
changed at the same time as HCS (71 FR
at 53623, 53626).
In response to the ANPR, the majority
of commenters who addressed the
impact of the GHS on other OSHA
standards recommended the Agency
review all its standards and update
them for consistency with GHS
(Document ID #s 0046, 0050, 0054,
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0072, 0077, 0179, 0031, 0038, 0107,
0116, 0145, 0147, 0154, 0155, 0163,
0165, and 0171). Abbott Laboratories
addressed the issue in terms of
substance specific standards:
OSHA should conduct a complete review
of substance specific standards and
determine how they need to be changed in
order to be consistent with GHS. These
changes should be made concurrent with the
implementation of GHS. (Document ID #
0046)
Other commenters agreed, urging
OSHA to complete these revisions in
one rulemaking. (Document ID #s 0079,
0123, 0137, 0154, and 0157). For
example, the National Paint & Coatings
Association, whose members produce
up to 70,000 formulated products, urged
OSHA to update the standards impacted
by the GHS modification to the HCS to
‘‘minimize discrepancies and
inconsistency’’. (Document ID # 0050).
Similar views were expressed by the
Marshfield Clinic, the Hazard
Communication Group and BASF
(Document ID #s 0028, 0154, 0119,
0145, and 0155). NIOSH supported
OSHA’s plan to ‘‘adopt the specific
labeling requirement and the safety data
sheet (SDS) order of information’’ in the
GHS, which, if substance specific
standards were not included, would
lead to internal inconsistencies
(Document ID # 0081). The American
Chemical Society noted that it would be
best if OHSA identifies and updates all
affected OSHA standards at once,
otherwise industry may not realize all
potential benefits (Document ID # 0165).
The Association of Occupational Health
Professionals in Healthcare (AOHP)
stated:
The standardization needs to be applied
from the beginning until the end of the
production, through distribution and use by
the end user. We would recommend that any
other OSHA standards that would be affected
by the adoption of the HCS be changed to
coincide with the implementation of the
HCS’’ (Document ID # 0051)
Of the commenters who specifically
addressed adopting GHS provisions on
physical hazards, many urged the
Agency to conform the OSHA standards
to the GHS in order to minimize
discrepancies and ensure consistency
(Document ID #s 0050, 0072, 0104,
0105, 0018, 0012, 0144, 0139 and 0140).
One commenter, 3M, noted that
adoption of the GHS physical hazard
criteria (without changing OSHA
standards) would ‘‘create unacceptable
inconsistencies between OSHA
standards’’ (Document ID # 0128).
However, several of the commenters
pointed out some of the difficulties with
adoption of the GHS physical hazards
criteria (Document ID #s 0077, 0031,
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0034, 0038, 0145, and 0166). MRS
Associates stated that ‘‘flammability is
the key physical hazard that needs to
have consistent definition and criteria
because it affects other standards’’
(Document ID # 0145). Other
commenters agreed with MRS associates
(Document ID #s 0072, 0105, 0179,
0145, and 0163). Manufacturer 3M
posited that ‘‘consistent classification
between HCS and storage and handling
requirements is the most critical
potential problem’’ (Document ID #
0128). However, some commenters
recommended OSHA limit changes in
order to facilitate GHS implementation.
(Document ID #s 0047, 0064, 0077,
0104, and 0115). Dow Chemical wrote:
Dow believes that OSHA should
implement only those changes needed to
facilitate GHS implementation. While this
may necessitate some duplicative
information on SDSs (for example, listing
both GHS and NFPA flammability
classifications), this would cause less
disruption and confusion than trying to make
changes i[n] associated standards that might
then be in conflict with other current
standards outside OSHA’s control (for
example, State and local building and fire
codes) (Document ID # 0047).
OSHA’s proposal reflects the
advantages of harmonizing, but takes
into account the places where
harmonization might be too difficult at
this time because it would substantially
change the scope of coverage of a
current standard or make OSHA’s
standards incompatible with other
widely accepted standards.
OSHA reviewed all its standards and
has proposed changes to ensure that
they are internally harmonized to
facilitate safety and health for the
employer and employee. To that end,
OSHA is proposing to apply the GHS
elements it is adopting in the modified
HCS to its other standards. Provisions in
OSHA standards, such as the substancespecific standards that set forth hazard
and precautionary statements will be
changed to be consistent with GHS
terminology. Also, OSHA is proposing
to modify provisions of the standards
that reference the HCS definitions to
maintain coverage or consistency with
the modified HCS, and to change
provisions in standards that affect the
information requirements of the safety
data sheet (SDS). OSHA will also
maintain the current HCS definitions in
the several standards that reference the
HCS for which the adoption of GHS
definitions could potentially impact the
scope of those standards.
Some standards are not being
included in this rulemaking. As
explained in more detail below, OSHA
is not proposing at this time to change
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certain standards that reference
consensus standards such as National
Fire Protection Association (NFPA)
standards. In addition, OSHA is not
proposing any changes in 29 CFR
1910.109 Explosives and Blasting
Agents and 29 CFR 1926.914 definitions
for Blasting in Excavation Work Under
Compressed Air.
Substance Specific Health Standards
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OSHA proposes to update substancespecific health standards in General
Industry, Construction, and Maritime,
whether they specifically reference HCS
or contain their own hazard
communication requirements. OSHA is
proposing to modify these standards in
the following areas:
• Revise the provisions covering
workplace signs to require warning
statements that are consistent with the
GHS modifications to HCS;
• Revise all standards to reference the
modified HCS for labels, safety data
sheets, and training, and identify the
hazards that need to be addressed;
• Maintain the requirement to avoid
creating dust currently in some
substance-specific health standards, but
for which GHS modifications contain no
equivalent statements at this time;
• Maintain or specify language for
contaminated clothing and debris;
• Update most definitions in
§ 1910.1450, Occupational Exposure to
Hazardous Chemicals in Laboratories, to
maintain compatibility with the
modified HCS; and
• Change the name Material Safety
Data Sheets to Safety Data Sheets and
require information on them to be
compliant with GHS in content, format
and order.
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OSHA is proposing to update the
language for workplace signs and labels
to incorporate the GHS hazard statement
and the applicable precautionary
statement(s), where required. Most
OSHA substance-specific health
standards require hazard warning signs,
usually for regulated areas, and the
language required on the signs varies
greatly (e.g., Asbestos, 4-Nitrobiphenyl,
13 Carcinogens, Vinyl Chloride,
Inorganic Arsenic, Cadmium, Benzene,
Coke Oven Emissions, Cotton Dust,
DBCP, Acrylonitrile, Formaldehyde,
Methylenedianiline, 1,3-Butadiene,
Methylene Chloride, and Lead). With
the GHS revision, these standards retain
the requirements for specific warning
language for specific signs; however,
OSHA is proposing to modify the
language to be compatible with GHS
and consistent throughout the OSHA
standards.
OSHA believes that having signs and
labels in the same formats and
containing identical warnings for the
same health effects will make it far
easier for employers and employees to
quickly recognize the hazard and the
degree of danger of a hazard, thus
enhancing communication. For
example, many of the substance-specific
health standards were regulated as
carcinogens; however, the hazard
statements required on signs and labels
range from ‘‘Cancer Hazard’’ in
Inorganic Arsenic (29 CFR 1910.1018) to
‘‘Cancer—Suspect agent’’ in Vinyl
Chloride (29 CFR 1910.1017) to ‘‘May
Cause Cancer’’ in Methylenediamiline
(MDA) (29 CFR 1910.1050). The GHS
revision to HCS will standardize the
warning language to ‘‘May Cause
Cancer’’ for each standard regulated as
a carcinogen. NAHB addressed this
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issue, positing that the different signal
words (‘‘Danger’’ versus ‘‘Warning’’) and
different hazard statements (‘‘May cause
cancer’’ versus ‘‘Suspected of causing
cancer’’) may create confusion
(Document ID # 0065). OSHA believes
that the signal words and hazard
statements in its substance-specific
standards would be more consistent if
they are changed to reflect the GHS
modification to HCS.
Currently, OSHA standards appear to
suggest gradations of cancer hazards
with ‘‘cancer hazard’’ seeming to signal
the greatest hazard. However, there is no
gradation of hazard. The standards were
promulgated at different times and
reflect the language used at the time and
not relative degrees of hazard. With
GHS harmonization, the potential
misperception of degree of carcinogenic
hazard is alleviated and the process is
simplified with one statement warning
that the chemical is carcinogenic. ‘‘May
Cause Cancer’’ means ‘‘carcinogen,’’ is
equivalent to any of the warnings for the
current standards, and communicates
the serious adverse health effects caused
by carcinogens. Nevertheless, NAHB’s
concerns with potential confusion over
hazard statements and signal words are
well taken. This highlights the need for
training. OSHA believes that after
hazard communication training ‘‘May
Cause Cancer’’ and other GHS
compliant warnings will be quickly
recognized and easily understood,
leading to more effective avoidance of
the various hazards to which workers
are exposed. See Table XV–1 for a
comparison of the language on current
signs to signs modified to be consistent
with the modified HCS.
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OSHA’s proposal would result in all
the substance-specific health standards
making reference to the HCS and would
remove the specific language that must
be included on a label for raw materials,
mixtures, and products. Currently,
OSHA substance-specific standards are
inconsistent in that some have their
own hazard communication
requirements while others reference the
HCS and still others are silent, but still
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are covered by HCS. The new paragraph
that will reference the modified HCS in
each substance specific standard states:
accordance with the provisions of HCS and
paragraph () of this section. The employer
shall provide information on at least the
following hazards: (insert hazards)
( ) Hazard communication. The employer
shall include (insert name of chemical) in the
workplace hazard communication program
established to comply with the Hazard
Communication Standard (HCS) (29 CFR
1910.1200). The employer shall ensure that
each employee has access to labels on
containers of (insert name of chemical) and
safety data sheets, and is trained in
Requiring standards to reference HCS
will ensure consistency with the GHS
revisions and consistency among the
standards, and consistency when the
specific chemical is part of a mixture.
Removal of the current specific warning
language is essential for adoption of the
GHS language. To leave these provisions
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in the standards would result in the
untenable situation of two potentially
conflicting requirements, only one of
which (the reference to HCS) would be
in accord with the GHS modifications.
Moreover, the hazard statements
specified for the chemical in the
standard may no longer be correct when
the chemical is part of the mixture. As
for the standards that now simply
reference HCS, labeling will no longer
be performance-oriented where
producers and employers could choose
any language and format that conveyed
the necessary information. The GHS
revision to HCS requires specific GHS
elements, including pictograms, hazard
and precautionary statements and signal
words on labels.
OSHA recognizes that employers have
relied upon the warning language for
labels in the substance-specific
standards and that the absence of
language where it had been in the
standard could cause some initial
confusion as to what, if anything, is
required. Therefore, OSHA is proposing
to provide guidance on the potential
health outcomes that must be reviewed
when classifying a substance. The
Agency is not attempting to formally
classify each substance; rather, OSHA is
proposing to provide a list of health
effects that will assist the classifier in
determining what must be considered
for inclusion on the new labels. The
GHS classification process for a specific
substance as proposed in this revision of
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the HCS will dictate the hazard
warnings and the precautionary
statements that will be required on the
new GHS-compliant labels. In
determining which hazards to include
in the substance specific standards, the
Agency’s primary sources on health
effects were its own information gained
in rulemaking and subsequent
experience, the NIOSH Pocket Guide to
Chemical Hazards (2005), and the
International Chemical Safety Cards
(ICSC), which are an undertaking of the
International Programme on Chemical
Safety (a joint activity of three
cooperating International Organizations:
namely the United Nations Environment
Programme (UNEP), the International
Labor Office (ILO) and the World Health
Organization (WHO)), and which are
peer reviewed by a group of
internationally recognized experts. As a
secondary source, OSHA also
considered the European Union’s (EU)
‘‘Proposal for a Regulation of the
European Parliament and of the Council
on classification, labelling and
packaging of substances and mixtures,
and amending Directive 67/548/EEC
and Regulation (EC) No 1907/2006’’.
From these sources, OSHA developed
hazard endpoints that were to be
included in the substance-specific
health standards based on two criteria:
(1) the health hazard was the basis for
the original rulemaking; or (2) the health
hazard was asserted by OSHA, NIOSH
or ICSC, and confirmed by a second
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source. For example, acrylonitrile (AN)
1910.1045 was regulated based on its
carcinogenicity. Skin sensitization was
acknowledged by OSHA, ICSC, and EU;
skin irritation by OSHA, NIOSH, and
EU; respiratory tract irritation by ICSC
and EU; eye irritation by OSHA, NIOSH,
and ICSC; liver effects and central
nervous system effects by ICSC and
NIOSH; acute toxicity by OSHA, ICSC,
and EU; and flammability by ICSC,
NIOSH and EU. Because all these effects
met the criteria for inclusion, skin
irritation, respiratory irritation, eye
irritation, liver effects, central nervous
system effects, acute toxicity, and
flammability were added as potential
hazards to AN. See Table XV–2 for the
proposed list of health effects for each
substance-specific health standard.
OSHA is proposing to maintain
specific language for labels in its
substance-specific health standards for
containers of contaminated clothing or
waste and debris even though these
labels may not be consistent with the
GHS. This is to ensure that protection
gained from communicating these
hazards to the downstream recipients of
the materials is not lessened. Substances
found on contaminated clothing and
waste and debris often occur in
unknown and frequently small
quantities. In order to ensure and
maintain protection for employees in
the receiving workplaces, labeling of
these hazards is essential.
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In addition, OSHA has determined
that the hazard and precautionary
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statements that address creating dust in
the substance-specific health standards
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must be maintained even though there
is no GHS equivalent. At this time, a
work group formed under the UN
Subcommittee of Experts for the GHS is
working to finalize issues related to
hazard and precautionary statements.
As indicated in Section II of this
preamble, this work is likely to be
accomplished prior to the promulgation
of the Hazard Communication final
standard (See UN/SCEGHS/15/INF.26).
If the UN subcommittee adopts a
precautionary statement for creating
dust, the paragraphs in the substancespecific standards can be removed and
protection will be attained by the GHS
modifications to HCS. However, if this
does not occur, OSHA intends to
continue to require them in the
standards.
OSHA’s Cadmium Standard provides
an example of this issue. In paragraphs
1910.1027(m)(3)(i) and (ii), containers
must be labeled in accordance with HCS
and the label must include the phrase
‘‘Avoid Creating Dust.’’ In this case,
there is no equivalent statement in GHS.
Therefore, OSHA would continue to
require this statement on labels. That
said, OSHA believes inclusion in GHS
would be the best way to require this
information and if the UN subcommittee
has completed its work in time, the
statements could be removed from the
standards, and the GHS modification to
HCS would be relied upon to require the
warning.
OSHA is proposing to modify most
definitions in § 1910.1450, Occupational
Exposure to Hazardous Chemicals in
Laboratories (the laboratory standard),
in order to maintain compatibility with
HCS. This is consistent with the goal of
this rulemaking and the original intent
of the laboratory standard. OSHA
explained in the preamble to the
laboratory standard the importance of
having the HCS and the laboratory
standard both use the same definitions
for hazardous chemicals.
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The term ‘‘hazardous chemical’’ used in
this final rule relies on the definition of
‘‘health hazard’’ found in the OSHA Hazard
Communication Standard. As discussed in
the scope and application section above,
commenters urged OSHA to maintain
consistency in terms between the Hazard
Communication Standard and this final
standard since laboratories are subject to both
regulations. (55 FR 3315 Jan. 31, 1990)
There is one exception in the
laboratory standard and that is the
definition of ‘‘select carcinogens.’’
(§ 1910.1450(b)). In this rulemaking,
OSHA is proposing to maintain the
current definition of ‘‘select
carcinogens’’ in the laboratory standard
since the original purpose of the
standard was to deviate from the HCS
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definition and narrow the scope of the
standard. As noted in the preamble, the
scope was set for ‘‘select carcinogens’’
based on the small, often minute,
quantities of substances handled. OSHA
stated its reasons for this deviation in
the preamble to the final rule and those
reasons remain persuasive
This final rule, however, modifies the
carcinogen definition and the obligatory
action so that special provisions must be
explicitly considered by the employer, but
need only be implemented when the
employer deems them appropriate on the
basis of the specific conditions existing in
his/her laboratory. Moreover, the term,
‘‘carcinogen’’ has been replaced by ‘‘select
carcinogen’’ which covers a narrower range
of substances * * * (55 FR 3315 Jan. 31,
1990)
OSHA is also proposing to change the
name of the ‘‘material safety data
sheets’’ for the substance specific
standards to ‘‘safety data sheets.’’ As
discussed above, this change is being
proposed to reflect the GHS
terminology.
Safety Standards
OSHA is proposing to modify safety
standards that either directly reference
the HCS or provide information
pertinent to the Safety Data Sheets
(SDSs), in particular regarding the
storage and handling of chemicals. As
noted above, some commenters
supported standardizing physical
hazard criteria across all applicable
OSHA standards (Document ID #s 0104,
0105, 0034, 0155, 0170, and 0171).
However, some other commenters, and
even some who supported applying
physical hazard criteria across all
standards, raised concerns about storage
and handling requirements; degree of
impact; potential effects on the scope of
the Process Safety Management (PSM)
Standard; and potential conflicts with
widely accepted consensus standards
(Document ID #s 0104, 0038, 0077, and
0163). OSHA is addressing all of these
concerns in this proposal. OSHA’s
proposed integration of the physical
hazards criteria would:
• Incorporate the current HCS
definitions of flammable liquid and gas
into PSM and health hazard into
Hazardous Waste Operations and
Emergency Response (HAZWOPER);
• Change paragraphs on flammable
and combustible liquids to conform in
categories, terminology, flashpoints (FP)
and boiling points (BP) to the GHS
modifications to HCS;
• Update the acceptable methods for
determining flashpoints;
• Modify the welding standard
§ 1910.252 requirements on labeling
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welding consumables to be consistent
with GHS modifications to HCS; and
• Incorporate the modified-HCS
definition of flammable aerosols into the
Flammable and Combustible Liquids
Standard § 1910.106 35; but
• Leave unchanged electrical
standards in Subpart S for general
industry and Subpart K for construction,
and explosive standards § 1910.109 for
general industry and § 1926.914 for
construction.
OSHA agrees with the commenters
who urged the Agency to ensure
consistency in its standards while
maintaining their scope (Document ID
#s 0049, 0050, 0077, 0105, 0123, 0145,
0163, and 0170). Two standards, PSM
and HAZWOPER, rely on definitions
from the HCS to define their scope. If
OSHA did not modify these standards
during this rulemaking, there would be
unintended coverage changes. For
example, PSM covers processes that
involve ‘‘flammable liquids’’ as
currently defined by reference to the
HCS which are limited to liquids with
a flashpoint below 100 °F. However, the
proposal incorporates the GHS
definitions for physical hazards and
defines flammable liquids as liquids
with a flashpoint below 199.4 °F,
potentially increasing the coverage of
PSM by adding flammable liquids with
flashpoints between 100 °F and 199.4 °F
to the chemicals PSM already covers.
Therefore, OSHA is proposing to change
the PSM standard to define ‘‘flammable
liquid’’ by the specific flashpoint set
forth in the current HCS, rather than
referencing HCS’s definition of
flammable liquid. Similarly for
‘‘flammable gas,’’ OSHA is proposing to
change the definition to only include
Category 1 flammable gas to maintain
coverage of PSM. Therefore, OSHA
would delete the reference to HCS for
flammable liquid and insert the current
definition in paragraph
1910.119(a)(1)(ii). The current PSM
standard states:
(ii) A process which involves a flammable
liquid or gas (as defined in 1910.1200(c) of
this part) on site in one location, in a
quantity of 10,000 pounds (4535.9 kg) * * *
The new proposed paragraph would
state:
(ii) A process which involves a Category 1
flammable gas (as defined in 1910.1200 (c))
or flammable liquid with a flashpoint below
100 °F (37.8 °C) on site in one location, in
a quantity of 10,000 pounds (4535.9 kg)
* * *
35 In § 1910.106 OSHA is also correcting a
rounding error in the conversion from 12 feet to
meters. The change is from 3.648 meters to 3.658
meters.
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Likewise, OSHA is proposing to
update the definition of health hazard in
HAZWOPER 1910.120 so the
terminology is aligned with the GHS
health hazards in Appendix A. The new
definition would read:
Health hazard means a chemical or a
pathogen where acute or chronic health
effects may occur in exposed employees. It
also includes stress due to temperature
extremes. The term ‘‘health hazard’’ includes
chemicals which are classified in accordance
with the Hazard Communication standard, 29
CFR 1910.1200 as posing one of the following
hazardous effects: Acute toxicity (any route
of exposure); skin corrosion or irritation;
serious eye damage or eye irritation;
respiratory or skin sensitization; germ cell
mutagenicity; carcinogenicity; reproductive
toxicity; target organ specific systemic
toxicity (single or repeated dose); or
aspiration toxicity. The criteria for
determining whether a chemical is classified
as a health hazard can be found in Appendix
A to 29 CFR 1910.1200.
OSHA was concerned that some of the
terminology in HAZWOPER, such as
neurotoxin and nephrotoxin (see
definitions in ‘‘health hazard’’) which
are partly defined by reference to the
HCS would no longer be consistent with
the modified HCS. OSHA has not
dropped these health hazards, but
instead, consistent with the GHS
modifications to HCS, such terms are
recatagorized under specific target organ
toxicity, thus maintaining the same
requirements for hazard
communication. If OSHA did not
update the definition in HAZWOPER
then employers would not have the
proper guidance on how to classify a
health hazard consistent with the GHS.
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Flammable and Combustible Liquids
OSHA is proposing to align the
definitions of flammable and
combustible liquids to conform to the
GHS modifications to HCS in categories,
terminology, flashpoints, and boiling
points, in the general industry,
construction, and maritime standards.
(See Table XV–3 for comparison of the
current HCS definitions and the GHS
flammable liquid definitions.) OSHA
believes that most of the changes in the
definitions are not significant. OSHA is
proposing to make nominal changes to
the flashpoint values for flammable and
combustible liquids from 22.8 ° C to 23
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°C and 93.3 °C to 93 °C to be consistent
with the GHS modifications to HCS.
OSHA believes these changes represent
simple rounding to the closest
significant value and that they will have
no effect on the scope of its standards
or safety, but will enable users to work
in whole numbers, which OSHA
believes will benefit affected employers
and employees.
However, other changes are
potentially significant. The boiling
points used to define the threshold for
the current Flammable Class IA will
shift from the cut-point of 37.8 °C to a
cut-point of 35 °C for Category 1 in the
modified HCS. Flammable Class IA is
currently defined as any liquid with a
FP of greater than (>) 22.8 °C and a BP
of less than (<) 37.8 °C; the new
definition will adopt a BP of less than
or equal to (≤) 35 ° C. Likewise, the BP
will shift for the current definition of
Flammable Class IB from equal to or
greater than (≥) 37.8 °C to (>) 35 °C for
Category 2. These changes are necessary
to make OSHA standards internally
consistent and consistent with the GHS
modifications to HCS. However, OSHA
is concerned that changing the boiling
point cut-off for the highly flammable
liquids currently classified as
Flammable IA could, under the GHS
modifications to HCS, lead to a subset
of these chemicals being classified as
GHS Category 2 Flammable Liquids.
Since some of the storage and handling
requirements are based on the hazard
category, a facility could increase the
size of its storage tanks for the liquids
with boiling points between 37.8 °C and
35 °C. It is possible that increasing the
size for these chemicals could decrease
the safety of their storage. OSHA has
reviewed the properties related to the
flammability of approximately 900
chemical substances (754 liquids) listed
in the CRC Handbook of Chemistry and
Physics [85th edition]. Approximately 1
percent of this list of flammable liquids
would result in a reclassification from
the current Flammable and Combustible
Liquids Standard Class IA to GHS
Category 2. While this is a small
percentage of the total flammable
liquids, it represents approximately 15
percent of the current Flammable and
Combustible Liquids Standard Class IA
liquids on this list. This is an instance
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where the benefits of harmonization
could be in conflict with the measure of
safety currently provided.
How the storage and handling of
chemicals would be affected by the
changes in classification of chemicals
generated significant comments to the
ANPR. Some commenters urged the
Agency to change criteria in the
standards, but acknowledged that the
storage and handling requirements for
flammable liquids would present the
most critical potential problems
(Document ID #s 0072, 0102, 0179,
0034, 0145, and 0163). Other
commenters were concerned that
changing the definitions, including
flammability criteria, would require
facilities to modify their storage
facilities to maintain compliance with
§ 1910.106, with some worried that
storage receptacles would have to be
smaller, leading to less storage and
greater costs. For example, BASF wrote:
The flammable and combustible liquid
standard, 29 CFR 1910.106, includes
definitions within the standard. Changing
these to be consistent with the GHS
definitions could require storage facilities to
be modified or the amount of storage
inventory limited, all of which impacts the
cost of implementation. (Document ID #
0119)
OSHA disagrees with this statement.
Because the GHS change from OSHA’s
flammable and combustible classes to
GHS Categories involves a lowering of
the boiling point cut-offs by 2.8 °C, all
current handling and storage would be
permitted. In addition, storage and
handling of chemicals whose boiling
points fall between 37.8 °C and 35 °C
would be allowed to be stored according
to the lesser flammability Category 2.
Category 2 chemicals could be stored in
larger containers but, as noted above, it
is possible that safety could be
compromised. OSHA is proposing the
GHS changes to the safety standards
because it believes safety will be
enhanced by the standardization of the
GHS modifications. However, OSHA is
seeking comment on the resulting
handling and storage of chemicals after
the standards have incorporated GHS
definitions, and the Agency has
included this topic in Section II (Issues)
of this preamble.
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Updating the Method To Determine
Flashpoint
Currently, OSHA references only
ASTM D–56–70 or ASTM D–93–71 for
testing methods to determine
flashpoints for liquids and these are the
only methods allowed. However, these
methods, which were developed in 1970
and 1971, have been updated and are
incompatible with GHS. To remedy this
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situation, OSHA is proposing to
reference the methods set forth in the
GHS that can be used to determine
flashpoints. These methods include
updated ASTM methods, ISO methods,
as well as British, French, and German
national standards for the testing. A
complete list of methods is in the
Globally Harmonized System of
Classification and Labelling of
Chemicals (GHS) (second revision,
2007). OSHA is seeking comment on
this approach, and the Agency has
included this topic in Section II (Issues)
of this preamble.
Welding, Cutting and Brazing
OSHA is proposing to modify the
labeling requirements for welding
consumables in the Welding, Cutting
and Brazing Standard, paragraphs
1910.252(c)(iv)(A), (B), and (C). These
paragraphs contain the labeling
requirements for filler metals, fusible
granular materials and fluxes. The
standard sets forth the responsibility for
labeling in paragraph 1910.252(c)(iv):
The suppliers of welding materials
shall determine the hazard, if any
associated with the use of their
materials in welding, cutting, etc.
Similar to the substance-specific health
standards, OSHA is proposing to require
these labels to be consistent with the
GHS modifications to HCS.
Flammable Aerosols
OSHA is proposing to harmonize its
existing standards with the GHS
modifications to HCS on flammable
aerosols. Currently OSHA references
CPSC regulations for its definition of
flammable aerosol. The current HCS
definition is:
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‘‘Aerosol, flammable’’ means an aerosol
that, when tested by the method described in
16 CFR 1500.45, yields a flame projection
exceeding 18 inches at full valve opening, or
a flashback (a flame extending back to the
valve) at any degree of valve opening.
OSHA defines and regulates flammable
aerosols in its Flammable and
Combustible Liquids standard at 29 CFR
1910.106. The definitions there are:
Aerosol shall mean a material which is
dispensed from its container as a mist, spray,
or foam by a propellant under pressure.
§ 1910.106(a)(1).
Flammable aerosol shall mean an aerosol
which is required to be labeled ‘‘Flammable’’
under the Federal Hazardous Substances
Labeling Act (15 U.S.C. 1261). For the
purposes of paragraph (d) of this section,
such aerosols are considered Class IA liquids.
§ 1910.106(a)(13).
Appendix B.3 of GHS modifications to
HCS begins its definition with what an
aerosol is:
* * * 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.
(Appendix B)
Aerosols are then further classified into
one of two categories if it contains a
flammable liquid, gas or solid
(Appendix B.3.2.1).
OSHA’s decision to change the
definition of aerosols to be consistent
with the GHS is based not only upon
harmonizing its own standards with
those followed by other countries who
have or are considering adopting GHS,
but also with making OSHA standards
internally consistent. OSHA believes
that the classification resulting from the
various methods are similar enough that
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OSHA is also proposing to adopt the
terminology in the GHS modifications to
HCS so that all liquids covered by
§ 1910.106 will be redefined as
flammable liquids in Categories 1–4, as
appropriate, and the term ‘‘Combustible
Liquids’’ in §§ 1910.106, 1910.107,
1910.123, 1910.125, 1926.152, and
1926.155 will be deleted. Instead of
using the term Combustible Class IIIB,
flammable liquids with a flashpoint of
≥ 93 °C will be called ‘‘Flammable
Liquids with a Flashpoint of > 93 °C.’’
The GHS does not classify flammable
liquids with flashpoints > 93 °C and, in
fact, does not use the term combustible
liquid for classification. However, other
OSHA standards, such as § 1910.107,
Spray Finishing Using Flammable and
Combustible Materials, relying on the
current § 1910.106 definitions of
flammable and combustible liquids,
which cover liquids with a flashpoint
over 93 °C as ‘‘combustible liquids.’’
OSHA believes it needs to maintain this
non-GHS category in order to preserve
the coverage of combustibles in
standards such as Spray Finishing.
However, these chemicals will be
known by the new term ‘‘Flammable
Liquids with a Flashpoint of Greater
Than 93°C,’’ which means that
protection provided by the current
standards remains in force.
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all aerosols currently regulated by
OSHA would continue to be so and that
few, if any, new aerosols would be
subject to OSHA regulation. Thus,
OSHA is proposing to remove the
current definitions from its Flammable
and Combustible Liquids standards and
insert its GHS consistent definitions
along with references to Appendix B.3
of the HCS. While the Agency believes
the effect of these changes will be
minimal, it nevertheless seeks comment
on this change which will primarily
affect the Flammable and Combustible
Liquids standards.
Standards Not Included in This
Rulemaking
At this time, OSHA is not proposing
to change standards that incorporate by
reference other consensus standards,
such as NFPA codes, or are based on
consensus standards when those
consensus standards are used for
internal design criteria only and do not
reference HCS for applicable scope or
incorporation into the SDS. These
standards would include subpart S—
Electrical in part 1910 (General
industry) and Subpart K—Electrical in
part 1926 (Construction). Many
commenters were particularly
concerned that a change in OSHA’s
definitions would create an
incompatibility with local building
codes (Document ID #s 0047, 0075,
0076, 0104, 0113, 0145 and 0163). In
many cases, this would require
extensive rewiring to meet the subpart
S requirements on hazardous locations
and would lead to conflicts with local
electrical codes.
In addition OSHA is not proposing to
update standards that pertain to
explosives at this time. A separate
rulemaking to revise the Explosive and
Blasting Agents standard § 1910.109 is
currently in progress.
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amend 29 CFR parts 1910, 1915 and
1926 as set forth below:
XVII. Authority and Signature
PART 1910—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS
[AMENDED]
This document was prepared under
the direction of Jordan Barab, Acting
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. 5–2007 (72 FR 31160); and 29
CFR part 1911.
Signed at Washington, DC, this 10th day of
September 2009.
Jordan Barab,
Acting Assistant Secretary of Labor.
XVIII. Proposed Amendments
List of Subjects
29 CFR Part 1910
Asbestos, Blood, Chemicals, Diving,
Fire prevention, Gases, Hazard
communication, Hazardous substances,
Health records, Labeling, Labels,
Laboratories, Occupational safety and
health, Reporting and recordkeeping
requirements, Safety data sheets, Signs
and symbols, and Training.
29 CFR Part 1915
Hazard communication, Hazardous
substances, Labels, Longshore and
harbor workers, Occupational safety and
health, Reporting and recordkeeping
requirements, Safety data sheets, Signs
and symbols, Training, and Vessels.
29 CFR Part 1926
Chemicals, Construction industry,
Diving, Fire prevention, Gases, Hazard
communication, Hazardous substances,
Health records, Labels, Lead,
Occupational safety and health,
Reporting and recordkeeping
requirements, Safety data sheets, Signs
and symbols, and Training.
For the reasons discussed in the
preamble, the Occupational Safety and
Health Administration proposes to
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Subpart A—[Amended]
1. The authority citation for subpart A
of part 1910 is revised to read as
follows:
Authority: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
(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), or 5–2007 (72
FR 31159), as applicable.
Section 1910.6 also issued under 5 U.S.C.
553. Sections 1910.6, 1910.7, and 1910.8 also
issued under 29 CFR Part 1911. Section
1910.7(f) also issued under 31 U.S.C. 9701,
29 U.S.C. 9a, 5 U.S.C. 553; Pub. L. 106–113
(113 Stat. 1501A–222); and OMB Circular A–
25 (dated July 8, 1993) (58 FR 38142, July 15,
1993).
2. Amend § 1910.6 by adding new
paragraphs (h)(22) through (h)(28),
(q)(36), (x), and (y) to read as follows:
§ 1910.6
Incorporation by reference.
*
*
*
*
*
(h) * * *
(22) ASTM D 56–93, Standard Test
Method for Flash Point by Tag Closed
Cup Tester, IBR approved for Appendix
B to § 1910.1200, (see B.6).
(23) ASTM D 3278–96, Standard Test
Method for Flash Point of Liquids by
Small Scale Closed-Cup Apparatus, IBR
approved for Appendix B to
§ 1910.1200.
(24) ASTM D 3828–93 Standard Test
Method for Flash Point by Small Scale
Closed Cup Tester, IBR approved for
Appendix B to § 1910.1200,.
(25) ASTM D 93–96, Standard Test
Methods for Flash Point by PenskyMartens Closed Cup Tester, IBR
approved for Appendix B to
§ 1910.1200.
(26) ASTM D 240–2007 Standard Test
Method for Heat of Combustion of
Liquid Hydrocarbon Fuels by Bomb
Calorimeter, IBR approved for Appendix
B to § 1910.1200.
(27) ASTM D 86–07a Standard Test
Method for Distillation of Petroleum
Products at Atmospheric Pressure, IBR
approved for Appendix B to
§ 1910.1200.
(28) ASTM D 1078–05 Standard Test
Method for Distillation Range of Volatile
Organic Liquids, IBR approved for
Appendix B to § 1910.1200.
*
*
*
*
*
(q) * * *
(36) NFPA 30B–2006 Code for the
Manufacture and Storage of Aerosol
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Products, IBR approved for Appendix B
to § 1910.1200.
*
*
*
*
*
(x) The following material is available
for purchase from the International
Standards Organization (ISO) through
ANSI, 25 West 43rd Street, Fourth Floor
New York, NY 10036–7417.
(1) ISO 10156–1996; ‘‘Gases and Gas
Mixtures—Determination of Fire
Potential and Oxidizing Ability for the
Selection of Cylinder Valve Outlets,’’
IBR approved for Appendix B to
§ 1910.1200.
(2) EN/ISO 13943–2000, 86.1 to
86.3—Fire Safety—Vocabulary, IBR
approved for Appendix B to § 1910.1200
(3) ISO 10156–2–2005 ‘‘Gas
cylinders—Gases and Gas Mixtures—
Part 2: Determination of Oxidizing
Ability of Toxic and Corrosive Gases
and Gas Mixtures,’’ IBR approved for
Appendix B to § 1910.1200.
*
*
*
*
*
(y) The following document is
available for purchase from United
Nations Publications, 2 United Nations
Plaza, Room DC2–853, New York, NY
10017, USA.
(1) The UN Recommendations on the
Transport of Dangerous Goods, Manual
of Tests and Criteria, Fourth Edition,
2003, IBR approved for Appendix B to
§ 1910.1200.
(2) [Reserved]
(z) The following is available from
Verein Deutscher Ingeniere
(VDI)(Association of German Engineers).
The guidelines can be ordered at: Beuth
Verlag GmbH, 10772 Berlin.
(1) The Grewer Oven test (VDI
guideline 2263, part 1, 1990, Test
methods for the Determination of the
Safety Characteristics of Dusts) with an
onset temperature 80 °K (176 °F) above
the reference temperature for a volume
of 1 l, IBR approved for Appendix B to
§ 1910.1200, (see B.11).
(2) [Reserved]
(aa) The following journal article can
be obtained on-line though Wiley
InterScience, at Journal Customer
Services, John Wiley & Sons, Inc., 350
Main Street, Malden, MA 02148.
(1) 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) (Copyright 1992 American
Institute of Chemical Engineers) with an
onset temperature 60°K (140°F) above
the reference temperature for a volume
of 1 l, IBR approved for Appendix B to
§ 1910.1200, (see B.11).
(2) [Reserved]
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Subpart H—[Amended]
3. The authority citation for subpart H
is revised to read as follows:
Authority: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
(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), or 5–2007 (72 FR 31159), as
applicable; and 29 CFR part 1911.
Sections 1910.103, 1910.106 through
1910.111, and 1910.119, 1910.120, and
1910.122 through 1910.126 also issued under
29 CFR part 1911.
Section 1910.119 also issued under Section
304, Clean Air Act Amendments of 1990
(Pub. L. 101–549), reprinted at 29 U.S.C. 655
NOTE. Section 1910.120 also issued under
Section 126, Superfund Amendments and
Reauthorization Act of 1986 as amended (29
U.S.C. 655 Note), and 5 U.S.C. 553.
4. Amend § 1910.106 as follows:
A. Revise the section heading;
B. Revise paragraphs (a)(13); (a)(14)(i)
through (a)(14)(iii) and (a)(19);
C. Remove the last sentence of
paragraph (a)(17);
D. Remove and reserve paragraph
(a)(18);
E. Remove the words ‘‘or
combustible’’ wherever it appears.
F. Remove the words ‘‘and
combustible’’ in paragraphs (d)(5)(vi)
introductory text, (e)(2) introductory
text, (j)(1) and (j)(3);
G. Revise paragraphs (b)(2)(iv)(f) and
(g), (b)(2)(vi)(b), (b)(2)(viii)(e), (b)(3)(i),
(b)(3)(iv)(a), (b)(3)(iv)(c), (b)(3)(v)(d),
(b)(4)(iv)(e), (d)(1)(ii)(b), (d)(2)(iii) and
(d)(2)(iii)(a)(2), (d)(3)(i), (d)(4)(iii),
(d)(4)(iv), (d)(7)(i)(b), (e)(2),
(e)(2)(ii)(b)(1), (e)(2)(ii)(b)(2),
(e)(2)(ii)(b)(3), (e)(2)(iv)(a), (e)(2)(iv)(c),
(e)(3)(v)(a), (e)(3)(v)(b), (e)(4)(i),
(e)(6)(ii), (e)(7)(i)(c), (f)(1)(i), (f)(1)(ii),
(f)(2)(ii), (f)(2)(iii)(a), (f)(2)(iii)(b),
(f)(2)(iii)(c), (f)(3)(i), (f)(3)(ii),
(f)(3)(iv)(a)(1), (f)(3)(iv)(a)(2),
(f)(3)(iv)(d)(2), (f)(3)(v), (f)(3)(vi),
(f)(4)(viii)(e), (f)(5)(i), (f)(6), (f)(8),
(g)(1)(i)(c), (g)(1)(i)(e), (g)(1)(i)(f),
(g)(1)(iii)(a), (g)(1)(iii)(b), (g)(1)(iii)(c),
(g)(1)(v), (g)(3)(iv)(a), (g)(3)(iv)(b)(1),
(g)(3)(iv)(b)(2), (g)(3)(iv)(c), (g)(3)(v)(a),
(g)(3)(vi)(a), (g)(4)(iii)(d), (g)(5)(i),
(g)(6)(iv), (g)(7), (h)(3)(i)(a), (h)(3)(iii)(b),
(h)(3)(iv), (h)(5), (h)(7)(i)(b), (h)(7)(iii)(c),
(j), and Tables H–12, H–14 through H–
17, and H–19;
The revisions read as follows:
§ 1910.106
Flammable liquids.
*
*
*
*
*
(a) * * *
(13) Flammable aerosol shall mean a
flammable aerosol as defined by
Appendix B to § 1910.1200—Physical
Hazard Criteria. For the purposes of
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50421
paragraph (d) of this section, such
aerosols are considered Category 1
flammable liquids.
(14) * * *
(i) For a liquid which has a viscosity
of less than 45 SUS at 100 ßF (37.8 °C),
does not contain suspended solids, and
does not have a tendency to form a
surface film while under test, the
procedure specified in the Standard
Method of Test for Flashpoint by Tag
Closed Tester (ASTM D–56–70), which
is incorporated by reference as specified
in Sec. 1910.6, shall be used or an
equivalent test method as defined in
Appendix B to § 1910.1200—Physical
Hazard Criteria.
(ii) For a liquid which has a viscosity
of 45 SUS or more at 100 °F (37.8 °C),
or contains suspended solids, or has a
tendency to form a surface film while
under test, the Standard Method of Test
for Flashpoint by Pensky-Martens
Closed Tester (ASTM D–93–71) shall be
used or an equivalent method as defined
by Appendix B to § 1910.1200—
Physical Hazard Criteria, except that the
methods specified in Note 1 to section
1.1 of ASTM D–93–71 may be used for
the respective materials specified in the
NOTE: The preceding ASTM standards
are incorporated by reference as
specified in § 1910.6.
(iii) For a liquid that is a mixture of
compounds that have different
volatilities and flashpoints, its
flashpoint shall be determined by using
the procedure specified in paragraph
(a)(14)(i) or (ii) of this section on the
liquid in the form it is shipped.
*
*
*
*
*
(18) [Reserved]
(19) Flammable liquid means any
liquid having a flashpoint at or below
199.4 °F (93 °C). Flammable liquids are
divided into four categories as follows:
(i) Category 1 shall include liquids
having flashpoints below 73.4 °F (23 °C)
and having a boiling point at or below
95 °F (35 °C).
(ii) Category 2 shall include liquids
having flashpoints below 73.4 °F (23 °C)
and having a boiling point above 95 °F
(35 °C).
(iii) Category 3 shall include liquids
having flashpoints at or above 73.4 °F
(23 °C) and at or below 140 °F (60 °C).
When a Category 3 liquid with a
flashpoint at or above 100 °F (37.8 °C)
is heated for use to within 30 °F (16.7
°C) of its flashpoint, it shall be handled
in accordance with the requirements for
a Category 3 liquid with a flashpoint
below 100 °F (37.8 °C).
(iv) Category 4 shall include liquids
having flashpoints above 140 °F (60 °C)
and at or below 199.4 °F (93 °C). When
a Category 4 flammable liquid is heated
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for use to within 30 °F (16.7 °C) of its
flashpoint, it shall be handled in
accordance with the requirements for a
Category 3 liquid with a flashpoint at or
above 100 °F (37.8 °C).
(v) When liquid with a flashpoint
greater than 199.4 °F (93 °C) is heated
for use to within 30 °F (16.7 °C) of its
flashpoint, it shall be handled in
accordance with the requirements for a
Category 4 flammable liquid.
*
*
*
*
*
(b) * * *
(2) * * *
(iv) * * *
(f) Tanks and pressure vessels storing
Category 1 flammable liquids shall be
equipped with venting devices which
shall be normally closed except when
venting to pressure or vacuum
conditions. Tanks and pressure vessels
storing Category 2 flammable liquids
and Category 3 flammable liquids with
a flashpoint below 100 °F (37.8 °C) shall
be equipped with venting devices which
shall be normally closed except when
venting under pressure or vacuum
conditions, or with approved flame
arresters.
Exemption: Tanks of 3,000 bbls.
capacity or less containing crude
petroleum in crude-producing areas;
and, outside aboveground atmospheric
tanks under 1,000 gallons capacity
containing other than Category 1
flammable liquids may have open vents.
(See paragraph (vi) (b) of this section.)
(g) Flame arresters or venting devices
required in paragraph (f) of this section
may be omitted for Category 2
flammable liquids and Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C) where conditions
are such that their use may, in case of
obstruction, result in tank damage.
*
*
*
*
*
(vi) * * *
(b) Where vent pipe outlets for tanks
storing Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
are adjacent to buildings or public ways,
they shall be located so that the vapors
are released at a safe point outside of
buildings and not less than 12 feet
above the adjacent ground level. In
order to aid their dispersion, vapors
shall be discharged upward or
horizontally away from closely adjacent
walls. Vent outlets shall be located so
that flammable vapors will not be
trapped by eaves or other obstructions
and shall be at least five feet from
building openings.
*
*
*
*
*
(viii) * * *
(e) For Category 2 flammable liquids
and Category 3 flammable liquids with
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a flashpoint below 100 °F (37.8 °C),
other than crude oils, gasolines, and
asphalts, the fill pipe shall be so
designed and installed as to minimize
the possibility of generating static
electricity. A fill pipe entering the top
of a tank shall terminate within 6 inches
of the bottom of the tank and shall be
installed to avoid excessive vibration.
*
*
*
*
*
(3) * * *
(i) Location. Excavation for
underground storage tanks shall be
made with due care to avoid
undermining of foundations of existing
structures. Underground tanks or tanks
under buildings shall be so located with
respect to existing building foundations
and supports that the loads carried by
the latter cannot be transmitted to the
tank. The distance from any part of a
tank storing Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
to the nearest wall of any basement or
pit shall be not less than 1 foot, and to
any property line that may be built
upon, not less than 3 feet. The distance
from any part of a tank storing Category
3 flammable liquids with a flashpoint at
or above 100 °F (37.8 °C) or Category 4
flammable liquids to the nearest wall of
any basement, pit or property line shall
be not less than 1 foot.
*
*
*
*
*
(iv) * * *
(a) Location and arrangement of vents
for Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C). Vent
pipes from tanks storing Category 1 or
2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall be so
located that the discharge point is
outside of buildings, higher than the fill
pipe opening, and not less than 12 feet
above the adjacent ground level. Vent
pipes shall discharge only upward in
order to disperse vapors. Vent pipes 2
inches or less in nominal inside
diameter shall not be obstructed by
devices that will cause excessive back
pressure. Vent pipe outlets shall be so
located that flammable vapors will not
enter building openings, or be trapped
under eaves or other obstructions. If the
vent pipe is less than 10 feet in length,
or greater than 2 inches in nominal
inside diameter, the outlet shall be
provided with a vacuum and pressure
relief device or there shall be an
approved flame arrester located in the
vent line at the outlet or within the
approved distance from the outlet.
*
*
*
*
*
(c) Location and arrangement of vents
for Category 3 flammable liquids with a
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flashpoint at or above 100 °F (37.8 °C)
or Category 4 flammable liquids. Vent
pipes from tanks storing Category 3
flammable liquids with a flashpoint at
or above 100 °F (37.8 °C) or Category 4
flammable liquids shall terminate
outside of the building and higher than
the fill pipe opening. Vent outlets shall
be above normal snow level. They may
be fitted with return bends, coarse
screens or other devices to minimize
ingress of foreign material.
*
*
*
*
*
(v) * * *
(d) For Category 2 flammable liquids
and Category 3 flammable liquids with
a flashpoint below 100 °F (37.8 °C),
other than crude oils, gasolines, and
asphalts, the fill pipe shall be so
designed and installed as to minimize
the possibility of generating static
electricity by terminating within 6
inches of the bottom of the tank.
*
*
*
*
*
(4) * * *
(iv) * * *
(e) For Category 2 flammable liquids
and Category 3 flammable liquids with
a flashpoint below 100 °F (37.8 °C),
other than crude oils, gasoline, and
asphalts, the fill pipe shall be so
designed and installed as to minimize
the possibility of generating static
electricity by terminating within 6
inches of the bottom of the tank.
*
*
*
*
*
(d) * * *
(1) * * *
(ii) * * *
(b) Category 1, 2, or 3 flammable
liquids in the fuel tanks of a motor
vehicle, aircraft, boat, or portable or
stationary engine;
*
*
*
*
*
(2) * * *
(iii) Size. Flammable liquid containers
shall be in accordance with Table H–12,
except that glass or plastic containers of
no more than 1-gallon capacity may be
used for a Category 1 or 2 flammable
liquid if:
(a) * * *
(2) The user’s process either would
require more than 1 pint of a Category
1 flammable liquid or more than 1 quart
of a Category 2 flammable liquid of a
single assay lot to be used at one time,
or would require the maintenance of an
analytical standard liquid of a quality
which is not met by the specified
standards of liquids available, and the
quantity of the analytical standard
liquid required to be used in any one
control process exceeds one-sixteenth
the capacity of the container allowed
under Table H–12 for the category of
liquid; or
*
*
*
*
*
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(3) * * *
(i) Maximum capacity. Not more than
60 gallons of Category 1, 2, or 3
flammable liquids, nor more than 120
gallons of Category 4 flammable liquids
may be stored in a storage cabinet.
*
*
*
*
*
(4) * * *
(iii) Wiring. Electrical wiring and
equipment located in inside storage
rooms used for Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall be
approved under subpart S of this part
for Class I, Division 2 Hazardous
Locations; for Category 3 flammable
liquids with a flashpoint at or above 100
°F (37.8 °C) and Category 4 flammable
liquids, shall be approved for general
use.
(iv) Ventilation. Every inside storage
room shall be provided with either a
gravity or a mechanical exhaust
ventilation system. Such system shall be
designed to provide for a complete
change of air within the room at least
six times per hour. If a mechanical
exhaust system is used, it shall be
controlled by a switch located outside of
the door. The ventilating equipment and
any lighting fixtures shall be operated
by the same switch. A pilot light shall
be installed adjacent to the switch if
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), are
dispensed within the room. Where
gravity ventilation is provided, the fresh
air intake, as well as the exhaust outlet
from the room, shall be on the exterior
of the building in which the room is
located.
*
*
*
*
*
(7) * * *
(i) * * *
(b) At least one portable fire
extinguisher having a rating of not less
than 12–B units must be located not less
than 10 feet, nor more than 25 feet, from
any Category 1, 2, or 3 flammable liquid
storage area located outside of a storage
room but inside a building.
*
*
*
*
*
(e) * * *
(2) * * *
(ii) * * *
(b) * * *
(1) 25 gallons of Category 1 flammable
liquids in containers
(2) 120 gallons of Category 2, 3, or 4
flammable liquids in containers
(3) 660 gallons of Category 2, 3, or 4
flammable liquids in a single portable
tank.
*
*
*
*
*
(iv) * * *
(a) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
VerDate Nov<24>2008
23:10 Sep 29, 2009
Jkt 217001
flashpoint below 100 °F (37.8 °C), shall
be kept in covered containers when not
actually in use.
*
*
*
*
*
(c) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), may
be used only where there are no open
flames or other sources of ignition
within the possible path of vapor travel.
*
*
*
*
*
(3) * * *
(v) * * *
(a) Areas as defined in paragraph
(e)(3)(i) of this section using Category 1
or 2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall be
ventilated at a rate of not less than 1
cubic foot per minute per square foot of
solid floor area. This shall be
accomplished by natural or mechanical
ventilation with discharge or exhaust to
a safe location outside of the building.
Provision shall be made for introduction
of makeup air in such a manner as not
to short circuit the ventilation.
Ventilation shall be arranged to include
all floor areas or pits where flammable
vapors may collect.
(b) Equipment used in a building and
the ventilation of the building shall be
designed so as to limit flammable vaporair mixtures under normal operating
conditions to the interior of equipment,
and to not more than 5 feet from
equipment which exposes Category 1 or
2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), to the air.
Examples of such equipment are
dispensing stations, open centrifuges,
plate and frame filters, open vacuum
filters, and surfaces of open equipment.
*
*
*
*
*
(4) * * *
(i) Tank vehicle and tank car loading
or unloading facilities shall be separated
from aboveground tanks, warehouses,
other plant buildings or nearest line of
adjoining property which may be built
upon by a distance of 25 feet for
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), and
15 feet for Category 3 flammable liquids
with a flashpoint at or above 100 °F
(37.8 °C) and Category 4 flammable
liquids measured from the nearest
position of any fill stem. Buildings for
pumps or shelters for personnel may be
a part of the facility. Operations of the
facility shall comply with the
appropriate portions of paragraph (f)(3)
of this section.
*
*
*
*
*
(6) * * *
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50423
(ii) Grounding. Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall not be
dispensed into containers unless the
nozzle and container are electrically
interconnected. Where the metallic
floorplate on which the container stands
while filling is electrically connected to
the fill stem or where the fill stem is
bonded to the container during filling
operations by means of a bond wire, the
provisions of this section shall be
deemed to have been complied with.
(7) * * *
(i) * * *
(c) Locations where flammable vaporair mixtures may exist under abnormal
conditions and for a distance beyond
Division 1 locations shall be classified
Division 2 according to the
requirements of subpart S of this part.
These locations include an area within
20 feet horizontally, 3 feet vertically
beyond a Division 1 area, and up to 3
feet above floor or grade level within 25
feet, if indoors, or 10 feet if outdoors,
from any pump, bleeder, withdrawal
fitting, meter, or similar device handling
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C). Pits
provided with adequate mechanical
ventilation within a Division 1 or 2 area
shall be classified Division 2. If Category
3 flammable liquids with a flashpoint at
or above 100 °F (37.8 °C) or Category 4
flammable liquids only are handled,
then ordinary electrical equipment is
satisfactory though care shall be used in
locating electrical apparatus to prevent
hot metal from falling into open
equipment.
*
*
*
*
*
(f) * * *
(1) * * *
(i) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C).
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), shall
be stored in closed containers, or in
storage tanks above ground outside of
buildings, or underground in
accordance with paragraph (b) of this
section.
(ii) Category 3 flammable liquids with
a flashpoint at or above 100 °F (37.8 °C)
and Category 4 flammable liquids.
Category 3 flammable liquids with a
flashpoint at or above 100 °F (37.8 °C)
and Category 4 flammable liquids shall
be stored in containers, or in tanks
within buildings or above ground
outside of buildings, or underground in
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accordance with paragraph (b) of this
section.
*
*
*
*
*
(2) * * *
(ii) Heating. Rooms in which Category
1 or 2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), are stored or
handled shall be heated only by means
not constituting a source of ignition,
such as steam or hot water. Rooms
containing heating appliances involving
sources of ignition shall be located and
arranged to prevent entry of flammable
vapors.
(iii) * * *
(a) Ventilation shall be provided for
all rooms, buildings, or enclosures in
which Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
are pumped or dispensed. Design of
ventilation systems shall take into
account the relatively high specific
gravity of the vapors. Ventilation may be
provided by adequate openings in
outside walls at floor level unobstructed
except by louvers or coarse screens.
Where natural ventilation is inadequate,
mechanical ventilation shall be
provided.
(b) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), shall
not be stored or handled within a
building having a basement or pit into
which flammable vapors may travel,
unless such area is provided with
ventilation designed to prevent the
accumulation of flammable vapors
therein.
(c) Containers of Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall not be
drawn from or filled within buildings
unless provision is made to prevent the
accumulation of flammable vapors in
hazardous concentrations. Where
mechanical ventilation is required, it
shall be kept in operation while
flammable liquids with a flashpoint
below 100 °F (37.8 °C) are being
handled.
(3) * * *
(i) Separation. Tank vehicle and tank
car loading or unloading facilities shall
be separated from aboveground tanks,
warehouses, other plant buildings or
nearest line of adjoining property that
may be built upon by a distance of 25
feet for Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
and 15 feet for Category 3 flammable
liquids with a flashpoint at or above 100
°F (37.8 °C) and Category 4 flammable
liquids measured from the nearest
VerDate Nov<24>2008
23:10 Sep 29, 2009
Jkt 217001
position of any fill spout. Buildings for
pumps or shelters for personnel may be
a part of the facility.
(ii) Category restriction. Equipment
such as piping, pumps, and meters used
for the transfer of Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), between storage
tanks and the fill stem of the loading
rack shall not be used for the transfer of
Category 3 flammable liquids with a
flashpoint at or above 100 °F (37.8 °C)
or Category 4 flammable liquids.
*
*
*
*
*
(iv) * * *
(a) * * *
(1) Where Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
are loaded, or
(2) Where Category 3 flammable
liquids with a flashpoint at or above 100
°F (37.8 °C) or Category 4 flammable
liquids are loaded into vehicles which
may contain vapors from previous
cargoes of Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C).
*
*
*
*
*
(d) * * *
(2) Where no Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), are handled at
the loading facility and the tank
vehicles loaded are used exclusively for
Category 3 flammable liquids with a
flashpoint at or above 100 °F (37.8 °C)
and Category 4 flammable liquids; and
*
*
*
*
*
(v) Stray currents. Tank car loading
facilities where Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C) are loaded
through open domes shall be protected
against stray currents by bonding the
pipe to at least one rail and to the rack
structure if of metal. Multiple lines
entering the rack area shall be
electrically bonded together. In
addition, in areas where excessive stray
currents are known to exist, all pipe
entering the rack area shall be provided
with insulating sections to electrically
isolate the rack piping from the
pipelines. No bonding between the tank
car and the rack or piping is required
during either loading or unloading of
Category 3 flammable liquids with a
flashpoint at or above 100 °F (37.8 °C)
or Category 4 flammable liquids.
(vi) Container filling facilities.
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), shall
not be dispensed into containers unless
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the nozzle and container are electrically
interconnected. Where the metallic
floorplate on which the container stands
while filling is electrically connected to
the fill stem or where the fill stem is
bonded to the container during filling
operations by means of a bond wire, the
provisions of this section shall be
deemed to have been complied with.
(4) * * *
(viii) * * *
(e) In addition to the requirements of
paragraph (f)(4)(viii)(d) of this section,
each line conveying Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), leading to a
wharf shall be provided with a readily
accessible block valve located on shore
near the approach to the wharf and
outside of any diked area. Where more
than one line is involved, the valves
shall be grouped in one location.
*
*
*
*
*
(5) * * *
(i) Application. This paragraph
(f)(5)(i) shall apply to areas where
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), are
stored or handled. For areas where
Category 3 flammable liquids with a
flashpoint at or above 100 °F (37.8 °C)
or Category 4 flammable liquids only are
stored or handled, the electrical
equipment may be installed in
accordance with the provisions of
Subpart S of this part, for ordinary
locations.
*
*
*
*
*
(6) Sources of ignition. Category 1 or
2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall not be
handled, drawn, or dispensed where
flammable vapors may reach a source of
ignition. Smoking shall be prohibited
except in designated localities. ‘‘No
Smoking’’ signs shall be conspicuously
posted where hazard from flammable
liquid vapors is normally present.
*
*
*
*
*
(8) Fire control. Suitable fire-control
devices, such as small hose or portable
fire extinguishers, shall be available to
locations where fires are likely to occur.
Additional fire-control equipment may
be required where a tank of more than
50,000 gallons individual capacity
contains Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
and where an unusual exposure hazard
exists from surrounding property. Such
additional fire-control equipment shall
be sufficient to extinguish a fire in the
largest tank. The design and amount of
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such equipment shall be in accordance
with approved engineering standards.
*
*
*
*
*
(g) * * *
(1) * * *
(i) * * *
(c) Apparatus dispensing Category 1
or 2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), into the fuel
tanks of motor vehicles of the public
shall not be located at a bulk plant
unless separated by a fence or similar
barrier from the area in which bulk
operations are conducted.
*
*
*
*
*
(e) The provisions of paragraph
(g)(1)(i)(a) of this section shall not
prohibit the dispensing of flammable
liquids with a flashpoint below 100 °F
(37.8 °C) in the open from a tank vehicle
to a motor vehicle. Such dispensing
shall be permitted provided:
*
*
*
*
*
(f) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), shall
not be stored or handled within a
building having a basement or pit into
which flammable vapors may travel,
unless such area is provided with
ventilation designed to prevent the
accumulation of flammable vapors
therein.
*
*
*
*
*
(iii) * * *
(a) Except where stored in tanks as
provided in paragraph (g)(1)(ii) of this
section, no Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
shall be stored within any service
station building except in closed
containers of aggregate capacity not
exceeding 60 gallons. One container not
exceeding 60 gallons capacity equipped
with an approved pump is permitted.
(b) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), may
be transferred from one container to
another in lubrication or service rooms
of a service station building provided
the electrical installation complies with
Table H–19 and provided that any
heating equipment complies with
paragraph (g)(6) of this section.
(c) Category 3 flammable liquids with
a flashpoint at or above 100 °F (37.8 °C)
and Category 4 flammable liquids may
be stored and dispensed inside service
station buildings from tanks of not more
than 120 gallons capacity each.
*
*
*
*
*
(v) Dispensing into portable
containers. No delivery of any Category
1 or 2 flammable liquids, or Category 3
flammable liquids with a flashpoint
VerDate Nov<24>2008
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Jkt 217001
below 100 °F (37.8 °C), shall be made
into portable containers unless the
container is constructed of metal, has a
tight closure with screwed or spring
cover, and is fitted with a spout or so
designed so the contents can be poured
without spilling.
*
*
*
*
*
(3) * * *
(iv) * * *
(a) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), shall
be transferred from tanks by means of
fixed pumps so designed and equipped
as to allow control of the flow and to
prevent leakage or accidental discharge.
(b)(1) Only listed devices may be used
for dispensing Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C). No such device
may be used if it shows evidence of
having been dismantled.
(2) Every dispensing device for
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C),
installed after December 31, 1978, shall
contain evidence of listing so placed
that any attempt to dismantle the device
will result in damage to such evidence,
visible without disassembly or
dismounting of the nozzle.
(c) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), shall
not be dispensed by pressure from
drums, barrels, and similar containers.
Approved pumps taking suction
through the top of the container or
approved self-closing faucets shall be
used.
*
*
*
*
*
(v) * * *
(a) This paragraph (g)(3)(v) shall
apply to systems for dispensing
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), where
such liquids are transferred from storage
to individual or multiple dispensing
units by pumps located elsewhere than
at the dispensing units.
*
*
*
*
*
(vi) * * *
(a) A listed manual or automaticclosing type hose nozzle valve shall be
provided on dispensers used for the
dispensing of Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C).
*
*
*
*
*
(4) * * *
(iii) * * *
(a) * * *
*
*
*
*
*
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50425
(d) Piping handling Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall be
grounded to control stray currents.
(5) * * *
(i) Application. This paragraph (g)(5)
shall apply to areas where Category 1 or
2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), are stored or
handled. For areas where Category 3
flammable liquids with a flashpoint at
or above 100 °F (37.8 °C) or Category 4
flammable liquids are stored or handled
the electrical equipment may be
installed in accordance with the
provisions of subpart S of this part, for
ordinary locations.
*
*
*
*
*
(6) * * *
(iv) Work areas. Heating equipment
using gas or oil fuel may be installed in
the lubrication, sales, or service room
where there is no dispensing or
transferring of Cagetory 1 or 2
flammable liquids or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), provided the
bottom of the combustion chamber is at
least 18 inches above the floor and the
heating equipment is protected from
physical damage by vehicles. Heating
equipment using gas or oil fuel listed for
use in garages may be installed in the
lubrication or service room where
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), are
dispensed provided the equipment is
installed at least 8 feet above the floor.
*
*
*
*
*
(7) Drainage and waste disposal.
Provision shall be made in the area
where Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
are dispensed to prevent spilled liquids
from flowing into the interior of service
station buildings. Such provision may
be by grading driveways, raising door
sills, or other equally effective means.
Crankcase drainings and flammable
liquids shall not be dumped into sewers
but shall be stored in tanks or drums
outside of any building until removed
from the premises.
*
*
*
*
*
(h) * * *
(3) * * *
(i) * * *
(a) Processing buildings shall be of
fire-resistance or noncombustible
construction, except heavy timber
construction with load-bearing walls
may be permitted for plants utilizing
only stable Category 3 flammable
liquids with a flashpoint at or above 100
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Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Proposed Rules
°F (37.8 °C) or Category 4 flammable
liquids. Except as provided in paragraph
(h)(2)(ii) of this section or in the case of
explosion resistant walls used in
conjunction with explosion relieving
facilities, see paragraph (h)(3)(iv) of this
section, load-bearing walls are
prohibited. Buildings shall be without
basements or covered pits.
*
*
*
*
*
(iii) * * *
(b) Equipment used in a building and
the ventilation of the building shall be
designed so as to limit flammable vaporair mixtures under normal operating
conditions to the interior of equipment,
and to not more than 5 feet from
equipment which exposes Category 1 or
2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), to the air.
Examples of such equipment are
dispensing stations, open centrifuges,
plate and frame filters, open vacuum
filters, and surfaces of open equipment.
(iv) Explosion relief. Areas where
Category 1 or unstable liquids are
processed shall have explosion venting
through one or more of the following
methods:
*
*
*
*
*
(5) Tank vehicle and tank car loading
and unloading. Tank vehicle and tank
car loading or unloading facilities shall
be separated from aboveground tanks,
warehouses, other plant buildings, or
nearest line of adjoining property which
may be built upon by a distance of 25
feet for Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
and 15 feet for Category 3 flammable
liquids with a flashpoint at or above 100
°F (37.8 °C) and Category 4 flammable
liquids measured from the nearest
position of any fill stem. Buildings for
pumps or shelters for personnel may be
a part of the facility. Operations of the
facility shall comply with the
appropriate portions of paragraph (f)(3)
of this section.
*
*
*
*
*
(7) * * *
(i) * * *
(b) Category 1 or 2 flammable liquids,
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), shall
not be dispensed into containers unless
the nozzle and container are electrically
interconnected. Where the metallic
floorplate on which the container stands
while filling is electrically connected to
the fill stem or where the fill stem is
bonded to the container during filling
operations by means of a bond wire, the
provisions of this section shall be
deemed to have been complied with.
*
*
*
*
*
(iii) * * *
(c) Locations where flammable vaporair mixtures may exist under abnormal
conditions and for a distance beyond
Division 1 locations shall be classified
Division 2 according to the
requirements of subpart S of this part.
These locations include an area within
20 feet horizontally, 3 feet vertically
beyond a Division 1 area, and up to 3
feet above floor or grade level within 25
feet, if indoors, or 10 feet if outdoors,
from any pump, bleeder, withdrawal
fitting, meter, or similar device handling
Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C). Pits
provided with adequate mechanical
ventilation within a Division 1 or 2 area
shall be classified Division 2. If Category
3 flammable liquids with a flashpoint at
or above 100 °F (37.8 °C) or Category 4
flammable liquids only are handled,
then ordinary electrical equipment is
satisfactory though care shall be used in
locating electrical apparatus to prevent
hot metal from falling into open
equipment.
*
*
*
*
*
(j) Scope. This section applies to the
handling, storage, and use of flammable
liquids with a flashpoint below 199.4 °F
(93 °C) unless otherwise noted. This
section does not apply to:
*
*
*
*
*
TABLE H–12—MAXIMUM ALLOWABLE SIZE OF CONTAINERS AND PORTABLE TANKS FOR FLAMMABLE LIQUIDS
Container type
Category 1
Category 2
Category 3
Category 4
Glass or approved plastic ........................................................................................................
Metal (other than DOT drums) ................................................................................................
Safety cans ..............................................................................................................................
Metal drums (DOT specifications) ...........................................................................................
Approved portable tanks ..........................................................................................................
1 pt ..........
1 gal ........
2 gal .........
60 gal ......
660 gal .....
1 qt ..........
5 gal .........
5 gal .........
60 gal .......
660 gal .....
1 gal .........
5 gal .........
5 gal .........
60 gal ......
660 gal .....
1 gal.
5 gal.
5 gal.
60 gal.
660 gal.
Note: Container exemptions: [a] Medicines, beverages, foodstuffs, cosmetics, and other common consumer items, when packaged according
to commonly accepted practices, shall be exempt from the requirements of 1910.106(d)(2)(i) and (ii).
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BILLING CODE 4510–26–C
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*
*
5. Amend § 1910.107 as follows:
A. Amend paragraphs (c)(9)(i), (e)(1),
(e)(2), (e)(3), (e)(6)(iv), (e)(8), and (e)(9)
by removing the terms ‘‘flammable or
combustible liquids’’ and replacing
them with the phrase ‘‘flammable
liquids or liquids with a flashpoint
greater than 199.4 °F (93 °C)’’ and;
B. Revise paragraphs (e) introductory
text and (e)(4) to read as follows:
srobinson on DSKHWCL6B1PROD with PROPOSALS2
§ 1910.107 Spray finishing using
flammable and combustible materials.
*
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*
*
(e) Flammable liquids and liquids
with a flashpoint greater than 199.4 °F
(93 °C)
*
*
*
*
*
(4) Transferring liquids. Except as
provided in paragraph (e)(5) of this
section the withdrawal of flammable
liquids and liquids with a flashpoint
greater than 199.4 °F (93 °C) from
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containers having a capacity of greater
than 60 gallons shall be by approved
pumps. The withdrawal of flammable
liquids or liquids with a flashpoint
greater than 199.4 °F (93 °C) from
containers and the filling of containers,
including portable mixing tanks, shall
be done only in a suitable mixing room
or in a spraying area when the
ventilating system is in operation.
Adequate precautions shall be taken to
protect against liquid spillage and
sources of ignition.
*
*
*
*
*
6. Amend § 1910.119 to revise
paragraphs (a)(1)(ii) introductory text,
(a)(1)(ii)(B) and the definition of ‘‘Trade
secret’’ in paragraph (b) to read as
follows:
§ 1910.119 Process safety management of
highly hazardous chemicals.
*
*
*
(a) * * *
(1) * * *
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(ii) A process which involves a
Category 1 flammable gas (as defined in
1910.1200 (c)) or a flammable liquid
with a flashpoint below 100 °F (37.8 °C)
on site in one location, in a quantity of
10,000 pounds (4535.9 kg) or more
except for:
*
*
*
*
*
(B) Flammable liquids with a
flashpoint below 100 °F (37.8 °C) stored
in atmospheric tanks or transferred
which are kept below their normal
boiling point without benefit of chilling
or refrigeration.
*
*
*
*
*
(b) Definitions. * * *
Trade secret means any confidential
formula, pattern, process, device,
information or compilation of
information that is used in an
employer’s business, and that gives the
employer an opportunity to obtain an
advantage over competitors who do not
know or use it. See Appendix E to
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§ 1910.1200—Definition of a Trade
Secret (which sets out the criteria to be
used in evaluating trade secrets).
*
*
*
*
*
7. In § 1910.120, revise the definition
of the term Health hazard in paragraph
(a)(3) to read as follows:
§ 1910.120 Hazardous waste operations
and emergency response.
(a) * * *
(3) * * *
Health hazard means a chemical or a
pathogen where acute or chronic health
effects may occur in exposed
employees. It also includes stress due to
temperature extremes. The term ‘‘health
hazard’’ includes chemicals which are
classified in accordance with the Hazard
Communication Standard, 29 CFR
1910.1200 as posing one of the
following effects: acute toxicity (any
route of exposure); skin corrosion or
irritation; serious eye damage or eye
irritation; respiratory or skin
sensitization; germ cell mutagenicity;
carcinogenicity; reproductive toxicity;
target organ specific systemic toxicity
(single or repeated dose); or aspiration
toxicity. See Appendix A to
§ 1910.1200—Health Hazard Criteria
(Mandatory) (for the criteria for
determining whether a chemical is
classified as a health hazard).
*
*
*
*
*
8. Amend paragraph (d) of § 1910.123,
by removing the term ‘‘Combustible
liquid’’ and revising the definitions of
the terms ‘‘Flammable liquid’’ and
‘‘Flashpoint’’ to read as follows:
§ 1910.123 Dipping and coating
operations: Coverage and definitions.
*
*
*
*
(d) * * *
Flammable liquid means a liquid
having a flashpoint below 199.4 °F. (93
°C.).
Flashpoint means the minimum
temperature at which a liquid gives off
a vapor in sufficient concentration to
ignite if tested in accordance with the
test methods in Appendix B to
§ 1910.1200—Physical Hazard Criteria.
*
*
*
*
*
9. In § 1910.124, revise paragraph
(c)(2) introductory text to read as
follows:
srobinson on DSKHWCL6B1PROD with PROPOSALS2
*
§ 1910.124 General requirements for
dipping and coating operations.
*
*
*
*
*
(c) * * *
(2) You must ensure that any exhaust
air re-circulated from a dipping or
coating operation using flammable
liquids or liquids with a flashpoint
greater than 199.4 °F (93 °C) is:
*
*
*
*
*
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10. Amend § 1910.125 introductory
text (including the table) to read as
follows:
§ 1910.125 Additional requirements for
dipping and coating operations that use
flammable or combustible liquids.
If you use flammable liquids, you
must comply with the requirements of
this section as well as the requirements
of §§ 1910.123, 1910.124, and 1910.126,
as applicable.
You must comply with
this section if:
And:
The flashpoint of the
liquid is 199.4 °F
(93 °C) or above.
The liquid is heated
as part of the operation; or a heated
object is placed in
the liquid.
*
*
*
*
*
Subpart Q—[Amended]
11. Continue the authority citation for
subpart Q to read as follows:
Authority: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, and 657); Secretary of
Labor’s Orders Nos. 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), or 5–2007
(72 FR 31159), as applicable; and 29 CFR part
1911.
12. Amend § 1910.252 as follows;
A. Revise paragraph (c)(1)(iv);
B. Add new paragraph (c)(1)(v).
§ 1910.252
General requirements.
*
*
*
*
*
(c) * * *
(1) * * *
(iv) Hazard communication. The
employer shall include the potentially
hazardous materials employed in fluxes,
coatings, coverings, and filler metals, all
of which are potentially used in welding
and cutting, or are released to the
atmosphere during welding and cutting,
in the program established to comply
with the Hazard Communication
Standard (HCS) (29 CFR 1910.1200).
The employer shall ensure that each
employee has access to labels on
containers of such materials and safety
data sheets, and is trained in accordance
with the provisions of 29 CFR
1910.1200. Potentially hazardous
materials shall include but not be
limited to the materials itemized in
paragraphs (c)(5) through (c)(12) of this
section.
(v) Additional considerations for
hazard communication in welding,
cutting, and brazing.
(A) The suppliers shall determine the
hazard as required by § 1910.1200, if
any, associated with the use of their
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50433
materials in welding, cutting, and
brazing.
(B) All filler metals and fusible
granular materials shall carry the
following notice, as a minimum, on tags,
boxes, or other containers:
Do not use in areas without adequate
ventilation
See ANSI Z49.1–1967 Safety in
Welding, Cutting, and Allied Processes
published by the American Welding
Society.
(C) Where brazing (welding) filler
metals contain cadmium in significant
amounts, the labels shall indicate the
hazards associated with cadmium
including cancer, lung and kidney
effects, and acute toxicity effects.
(D) Where brazing and gas welding
fluxes containing fluorine compounds,
the labels shall indicate the hazards
associated with fluorine compounds
including eye and respiratory tract
effects.
*
*
*
*
*
Subpart Z—[Amended]
13. Revise the authority citation for
subpart Z to read as follows:
Authority: Secs. 4, 6, 8, of the
Occupational Safety and Health Act of 1970
(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), or 5–2007 (72
FR 31159), as applicable; and 29 CFR part
1911.
All of subpart Z issued under section 6(b)
of the Occupational Safety and Health Act of
1970, except those substances that have
exposure limits listed in Tables Z–1, Z–2,
and Z–3 of 29 CFR 1910.1000. The latter
were issued under section 6(a) (29 U.S.C.
655(a)).
Section 1910.1000, Tables Z–1, Z–2 and
Z–3 also issued under 5 U.S.C. 553, Section
1910.1000 Tables Z–1, Z–2, and Z–3 but not
under 29 CFR part 1911 except for the
arsenic (organic compounds), benzene,
cotton dust, and chromium (VI) listings.
Section 1910.1001 also issued under
section 107 of the Contract Work Hours and
Safety Standards Act (40 U.S.C. 3704) and 5
U.S.C. 553.
Section 1910.1002 also issued under 5
U.S.C. 553, but not under 29 U.S.C. 655 or
29 CFR part 1911.
Sections 1910.1018, 1910.1029, and
1910.1200 also issued under 29 U.S.C. 653.
Section 1910.1030 also issued under Pub.
L. 106–430, 114 Stat. 1901.
14. Amend § 1910.1001 as follows:
A. Remove paragraph (j)(5);
B. Redesignate paragraphs (j)(1)
through (j)(4) as paragraphs (j)(2)
through (j)(5);
C. Revise paragraphs (h)(2)(iv),
(h)(3)(vi), the newly redesignated
paragraphs (j)(4), (j)(5), and the
introductory text of (j)(6).
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(h) * * *
(2) * * *
(iv) The employer shall ensure that
containers of contaminated protective
devices or work clothing, which are to
be taken out of change rooms or the
workplace for cleaning, maintenance or
disposal, bear labels in accordance with
paragraph (j) of this section.
(3) * * *
(vi) The employer shall ensure that
contaminated clothing is transported in
sealed impermeable bags, or other
closed, impermeable containers, and
labeled in accordance with paragraph (j)
of this section.
*
*
*
*
*
(j) * * *
(1) Hazard Communication—General.
The employer shall include asbestos in
the program established to comply with
the Hazard Communication Standard
(HCS) (29 CFR 1910.1200). The
employer shall ensure that each
employee has access to labels on
containers of asbestos and to safety data
sheets, and is trained in accordance
with the provisions of HCS and
paragraph (j)(7) of this section. The
employer shall ensure that at least the
following hazards are addressed: Cancer
and lung effects.
*
*
*
*
*
(4) Warning signs.
(i) Posting. Warning signs shall be
provided and displayed at each
regulated area. In addition, warning
signs shall be posted at all approaches
to regulated areas so that an employee
may read the signs and take necessary
protective steps before entering the area.
(ii) Sign specifications.
(A) The warning signs required by
paragraph (j)(4)(i) of this section shall
bear the following legend:
regulated areas comprehend the
warning signs required to be posted by
paragraph (j)(4)(i) of this section. Means
to ensure employee comprehension may
include the use of foreign languages,
pictographs and graphics.
(iv) At the entrance to mechanical
rooms/areas in which employees
reasonably can be expected to enter and
which contain ACM and/or PACM, the
building owner shall post signs which
identify the material which is present,
its location, and appropriate work
practices which, if followed, will ensure
that ACM and/or PACM will not be
disturbed. The employer shall ensure, to
the extent feasible, that employees who
come in contact with these signs can
comprehend them. Means to ensure
employee comprehension may include
the use of foreign languages,
pictographs, graphics, and awareness
training.
(5) Warning labels.
(i) Labeling. Labels shall be affixed to
all raw materials, mixtures, scrap,
waste, debris, and other products
containing asbestos fibers, or to their
containers. When a building owner or
employer identifies previously installed
ACM and/or PACM, labels or signs shall
be affixed or posted so that employees
will be notified of what materials
contain ACM and/or PACM. The
employer shall attach such labels in
areas where they will clearly be noticed
by employees who are likely to be
exposed, such as at the entrance to
mechanical room/areas. Signs required
by paragraph (j) of this section may be
posted in lieu of labels so long as they
contain information required for
labeling.
(ii) Label specifications. In addition to
the requirements of paragraph (j)(1), the
employer shall ensure that labels of bags
or containers of protective clothing and
equipment, scrap, waste, and debris
containing asbestos fibers include the
following information:
DANGER
DANGER
ASBESTOS
CONTAINS ASBESTOS FIBERS
MAY CAUSE CANCER
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
(B) In addition, where the use of
respirators and protective clothing is
required in the regulated area under this
section, the warning signs shall include
the following:
DO NOT BREATHE DUST
(6) The provisions for labels and for
safety data sheets required by paragraph
(j) of this section do not apply where:
*
*
*
*
*
15. Amend § 1910.1003 as follows:
A. Amend the last sentence in
paragraph (c)(4)(v) to remove the words
‘‘paragraphs (e)(2), (3), and (4)’’ and add
the words ‘‘paragraph (e)’’ in their place;
B. Revise the heading of paragraph (e);
C. Revise paragraphs (e)(1) and (e)(2)
D. Add new paragraph (j)(1);
The revisions, with new designations,
read as follows:
§ 1910.1001
Asbestos.
srobinson on DSKHWCL6B1PROD with PROPOSALS2
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AREA
(iii) The employer shall ensure that
employees working in and contiguous to
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D. Remove paragraph (e)(3);
E. Redesignate paragraphs (e)(4) and
(e)(5) as (e)(3) and (e)(4).
The revisions read as follows:
§ 1910.1003 13 Carcinogens
(4-nitrobiphenyl, etc.).
*
*
*
*
*
(e) Communication of hazards. (1)
Hazard communication. The employer
shall include the carcinogens listed
below in the program established to
comply with the Hazard
Communication Standard (HCS) (29
CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of the carcinogens
listed below and to safety data sheets,
and is trained in accordance with the
provisions of HCS and paragraph (e)(3)
of this section. The employer shall
ensure that at least the hazards listed for
the following chemicals are addressed:
4-Nitrobiphenyl: Cancer;
alpha-Naphthylamine: Cancer: skin
irritation, and acute toxicity effects;
Methyl chloromethyl ether: Cancer;
skin, eye and respiratory effects; acute
toxicity effects; and flammability;
3,3’-Dichlorobenzidine (and its salts):
Cancer and skin sensitization;
Bis-Chloromethyl ether: Cancer; skin,
eye, and respiratory tract effects; acute
toxicity effects; and flammability;
Beta-Naphthylamine: Cancer and
acute toxicity effects;
Benzidine: Cancer and acute toxicity
effects;
4-Aminodiphenyl: Cancer
Ethyleneimine: Cancer; mutagenicity;
skin and eye effects; liver effects; kidney
effects; acute toxicity effects; and
flammability;
Beta-Propiolactone: Cancer; skin
irritation; eye effects; and acute toxicity
effects;
2-Acetylaminofluorene: Cancer;
4-Dimethylaminoazo-benzene:
Cancer; skin effects; and respiratory
tract irritation;
N-Nitrosodimethylamine: Cancer;
liver effects; and acute toxicity effects;
(2) Signs. (i) The employer shall post
entrances to regulated areas with signs
bearing the legend:
DANGER
(CHEMICAL IDENTIFICATION)
MAY CAUSE CANCER
AUTHORIZED PERSONNEL ONLY
(ii) The employer shall post signs at
entrances to regulated areas containing
operations covered in paragraph (c)(5) of
this section. The signs shall bear the
legend:
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DANGER
legible and include the following
information:
WEAR AIR SUPPLIED HOODS,
IMPERVIOUS SUITS, AND
PROTECTIVE EQUIPMENT IN THIS
AREA
(iii) Appropriate signs and
instructions shall be posted at the
entrance to, and exit from, regulated
areas, informing employees of the
procedures that must be followed in
entering and leaving a regulated area.
*
*
*
*
*
16. Amend § 1910.1017 by revising
paragraph (l) to read as follows:
§ 1910.1018
Vinyl chloride.
*
*
*
*
(l) Communication of hazards. (1)
Hazard communication. The employer
shall include vinyl chloride in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of vinyl chloride
and to safety data sheets, and is trained
in accordance with the provisions of
HCS and paragraph (j) of this section.
The employer shall ensure that at least
the following hazards are addressed:
Cancer; central nervous system effects;
liver effects; blood effects; and
flammability.
(2) Signs. (i) The employer shall post
entrances to regulated areas with legible
signs bearing the legend:
DANGER
VINYL CHLORIDE
MAY CAUSE CANCER
AUTHORIZED PERSONNEL ONLY
(ii) The employer shall post signs at
areas containing hazardous operations
or where emergencies currently exist.
The signs shall be legible and bear the
legend:
DANGER
VINYL CHLORIDE
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AREA
AUTHORIZED PERSONNEL ONLY
(3) Labels. (i) In addition to the other
requirements in this paragraph (l), the
employer shall ensure that labels for
containers of polyvinyl chloride resin
waste from reactors or other waste
contaminated with vinyl chloride are
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Inorganic arsenic.
*
*
23:10 Sep 29, 2009
WEAR RESPIRATORY PROTECTION IN
THIS AREA
(4) No statement shall appear on or
near any required sign, label, or
instruction which contradicts or
detracts from the effect of any required
warning, information, or instruction.
*
*
*
*
*
17. Amend § 1910.1018 by revising
paragraphs (j)(2)(vii) and (p) as follows:
AUTHORIZED PERSONNEL ONLY
VerDate Nov<24>2008
MAY CAUSE CANCER
MAY CAUSE CANCER
MAY CAUSE CANCER
DANGER
CONTAMINATED WITH VINYL
CHLORIDE
(CHEMICAL IDENTIFICATION)
§ 1910.1017
50435
*
*
*
*
(j) * * *
(2) * * *
(vii) In addition to the communication
requirements in paragraph (p) of this
section, the employer shall ensure that
the containers of contaminated
protective clothing and equipment in
the workplace or which are to be
removed from the workplace are labeled
and that the labels include the following
information: DANGER:
CONTAMINATED WITH INORGANIC
ARSENIC. MAY CAUSE CANCER. DO
NOT EAT, DRINK, OR SMOKE. DO
NOT REMOVE DUST BY BLOWING OR
SHAKING.
*
*
*
*
*
(p) Communication of hazards.
(1) Hazard communication. (i) The
employer shall include inorganic
arsenic in the program established to
comply with the Hazard
Communication Standard (HCS) (29
CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of inorganic arsenic
and to safety data sheets, and is trained
in accordance with the provisions of
HCS and paragraph (o) of this section.
The employer shall ensure that at least
the following hazards are addressed:
Cancer; liver effects; skin effects;
respiratory irritation; nervous system
effects; and acute toxicity effects.
(ii) The employer shall ensure that no
statement appears on or near any sign or
label required by this paragraph which
contradicts or detracts from the meaning
of the required sign or label.
(2) Signs. (i) The employer shall post
signs demarcating regulated areas
bearing the legend:
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Sfmt 4702
INORGANIC ARSENIC
DO NOT EAT, DRINK OR SMOKE
AUTHORIZED PERSONNEL ONLY
(ii) The employer shall ensure that
signs required by this paragraph are
illuminated and cleaned as necessary so
that the legend is readily visible.
*
*
*
*
*
18. Amend § 1910.1025 to revise
paragraph (g)(2)(vii) and paragraph (m)
to read as follows:
§ 1910.1025
Lead.
*
*
*
*
*
(g) * * *
(2) * * *
(vii) The employer shall ensure that
labels of bags or containers of
contaminated protective clothing and
equipment include the following
information: DANGER: COTHING AND
EQUIPMENT CONTAMINATED WITH
LEAD. MAY DAMAGE FERTILITY OR
THE UNBORN CHILD. CAUSES
DAMAGE TO THE CENTRAL
NERVOUS SYSTEM. DO NOT EAT,
DRINK OR SMOKE WHEN HANDLING.
DO NOT REMOVE DUST BY BLOWING
OR SHAKING
*
*
*
*
*
(m) Communication of hazards. (1)
Hazard communication. The employer
shall include lead in the program
established to comply with the Hazard
Communication Standard (HCS) (29
CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of lead and to safety
data sheets, and is trained in accordance
with the provisions of HCS and
paragraph (l) of this section. The
employer shall ensure that at least the
following hazards are addressed:
Reproductive/developmental toxicity;
central nervous system effects; kidney
effects; blood effects; and acute toxicity
effects.
(2) Signs. (i) The employer shall post
the following warning signs in each
work area where the PEL is exceeded:
DANGER
LEAD
MAY DAMAGE FERTILITY OR THE
UNBORN CHILD
CAUSES DAMAGE TO THE CENTRAL
NERVOUS SYSTEM
DO NOT EAT, DRINK OR SMOKE IN
THIS AREA
(ii) The employer shall ensure that no
statement appears on or near any sign
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required by this paragraph which
contradicts or detracts from the meaning
of the required sign.
(iii) The employer shall ensure that
signs required by this paragraph are
illuminated and cleaned as necessary so
that the legend is readily visible.
*
*
*
*
*
19. Amend § 1910.1026 to revise
paragraphs (h)(2)(iv), (j)(3)(ii) and (l)(1)
to read as follows:
cleaning, maintenance or disposal are
labeled in accordance with paragraph
(m) of this section. As a minimum, the
employer shall ensure that labels on
containers of contaminated protective
clothing and equipment include the
following information:
§ 1910.1026
CAUSES DAMAGE TO LUNGS AND
KIDNEYS
Chromium (VI).
*
*
*
*
(h) * * *
(2) * * *
(iv) The employer shall ensure that
bags or containers of contaminated
protective clothing or equipment that
are removed from change rooms for
laundering, cleaning, maintenance, or
disposal are labeled in accordance with
the requirements of the Hazard
Communication standard, 29 CFR
1910.1200.
*
*
*
*
*
(j) * * *
(3) * * *
(ii) The employer shall ensure that
bags or containers of waste, scrap,
debris, and any other materials
contaminated with chromium (VI) that
are consigned for disposal are labeled in
accordance with the Hazard
Communication Standard, 29 CFR
1910.1200.
*
*
*
*
*
(l) * * *
(1) Hazard communication. The
employer shall include chromium (VI)
in the program established to comply
with the Hazard Communication
Standard (HCS) (29 CFR 1910.1200).
The employer shall ensure that each
employee has access to labels on
containers of chromium (VI) and to
safety data sheets, and is trained in
accordance with the provisions of HCS
and paragraph (l)(2) of this section. The
employer shall ensure that at least the
following hazards are addressed:
Cancer, eye irritation, and skin
sensitization.
*
*
*
*
*
20. Amend § 1910.1027 to revise
paragraphs (i)(2)(iv), (k)(7), (m)(1),
(m)(2)(ii), (m)(3)(i), and (m)(3)(ii) to read
as follows:
srobinson on DSKHWCL6B1PROD with PROPOSALS2
*
§ 1910.1027
Cadmium.
*
*
*
*
*
(i) * * *
(2) * * *
(iv) The employer shall ensure that
bags or containers of contaminated
protective clothing and equipment that
are to be taken out of the change rooms
or the workplace for laundering,
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DANGER
CONTAINS CADMIUM
DANGER
CONTAINS CADMIUM
MAY CAUSE CANCER
*
*
*
*
*
21. Amend § 1910.1028 to revise the
heading of paragraph (j) and the
regulatory text of paragraphs (j)(1) and
(j)(2) to read as follows:
§ 1910.1028
MAY CAUSE CANCER
AVOID CREATING DUST
*
*
*
*
*
(k) * * *
(7) Waste, scrap, debris, bags,
containers, personal protective
equipment, and clothing contaminated
with cadmium and consigned for
disposal shall be collected and disposed
of in sealed impermeable bags or other
closed, impermeable containers. These
bags and containers shall be labeled in
accordance with paragraph (m) of this
section.
*
*
*
*
*
(m) * * *
(1) Hazard communication. The
employer shall include cadmium in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of cadmium and to
safety data sheets, and is trained in
accordance with the provisions of HCS
and paragraph (m)(4) of this section.
The employer shall ensure that at least
the following hazards are addressed:
Cancer; lung effects; kidney effects; and
acute toxicity effects.
(2) * * *
(ii) Warning signs required by
paragraph (m)(2)(i) of this section shall
bear the following legend:
Benzene.
*
*
*
*
*
(j) Communication of hazards. (1)
Hazard communication. The employer
shall include benzene in the program
established to comply with the Hazard
Communication Standard (HCS) (29
CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of benzene and to
safety data sheets, and is trained in
accordance with the provisions of HCS
and (j)(3) of this section. The employer
shall ensure that at least the following
hazards are addressed: Cancer; central
nervous system effects; blood effects;
aspiration; skin, eye, and respiratory
tract irritation; and flammability.
Note to paragraph (j)(1) of this section:
There is no requirement to label pipes.
(2) Signs. The employer shall post
signs at entrances to regulated areas.
The signs shall bear the following
legend:
DANGER
BENZENE
MAY CAUSE CANCER
HIGHLY FLAMMABLE LIQUID AND
VAPOR
DO NOT SMOKE
WEAR RESPIRATORY PROTECTION IN
THIS AREA
AUTHORIZED PERSONNEL ONLY
DANGER
*
*
*
*
22. Amend § 1910.1029 to revise
paragraph (l) to read as follows:
CADMIUM
§ 1910.1029
MAY CAUSE CANCER
*
CAUSES DAMAGE TO LUNGS AND
KIDNEYS
WEAR RESPIRATORY PROTECTION IN
THIS AREA
AUTHORIZED PERSONNEL ONLY
(3) * * *
(i) Shipping and storage containers
containing cadmium or cadmium
compounds shall bear appropriate
warning labels, as specified in
paragraph (m)(1) of this section.
(ii) The warning labels for waste,
scrap, or debris shall include at least the
following information:
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*
Coke oven emissions.
*
*
*
*
(l) Communication of hazards. (1)
Hazard communication. The employer
shall include coke oven emissions in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of chemicals and
substances associated with coke oven
processes and to safety data sheets, and
is trained in accordance with the
provisions of HCS and paragraph (k) of
this section. The employer shall ensure
that at least the following hazard is
addressed: Cancer.
(2) Signs.
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*
*
*
*
(j) Signs. The employer shall post the
following warning sign in each work
area where the permissible exposure
limit for cotton dust is exceeded:
(v) Containers of DBCP contaminated
protective devices or work clothing
which are to be taken out of change
rooms or the workplace for cleaning,
maintenance or disposal, shall bear
labels in accordance with paragraph (o)
of this section. As a minimum, the
employer shall ensure that labels for
containers of contaminated protective
devices or work clothing include the
following information:
CONTAMINATED WITH 1,2-Dibromo3-chloropropane (DBCP), MAY CAUSE
CANCER.
*
*
*
*
*
(k) * * *
(1) * * *
(iii) * * *
(b) Portable vacuum units used to
collect DBCP may not be used for other
cleaning purposes and shall be labeled
as prescribed by paragraph (o) of this
section.
*
*
*
*
*
(o) Communication of hazards. (1)
General. (i) Hazard communication. The
employer shall include DBCP in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of DBCP and to
safety data sheets, and is trained in
accordance with the provisions of HCS
and paragraph (n) of this section. The
employer shall ensure that at least the
following hazards are addressed:
Cancer; reproductive effects; liver
effects; kidney effects; central nervous
system effects; skin, eye and respiratory
tract irritation; and acute toxicity
effects.
(ii) The employer shall ensure that no
statement appears on or near any sign or
label required by this paragraph which
contradicts or detracts from the meaning
of the required sign or label.
(2) Signs.
The employer shall post signs to
clearly indicate all regulated areas.
These signs shall bear the legend:
DANGER
DANGER
COTTON DUST
1,2-Dibromo-3-chloropropane
CAUSES DAMAGE TO LUNGS
MAY CAUSE CANCER
(BYSSINOSIS)
WEAR RESPIRATORY PROTECTION IN
THIS AREA
(i) The employer shall post signs in
the regulated area bearing the legend:
DANGER
COKE OVEN EMISSIONS
MAY CAUSE CANCER
DO NOT EAT, DRINK OR SMOKE
WEAR RESPIRATORY PROTECTION IN
THIS AREA
AUTHORIZED PERSONNEL ONLY
(ii) In addition, the employer shall
post signs in the areas where the
permissible exposure limit is exceeded
bearing the legend:
WEAR RESPIRATORY PROTECTION IN
THIS AREA
(iii) The employer shall ensure that no
statement appears on or near any sign
required by this paragraph which
contradicts or detracts from the effects
of the required sign.
(iv) The employer shall ensure that
signs required by this paragraph are
illuminated and cleaned as necessary so
that the legend is readily visible.
(3) Labels. In addition to the
requirements in (l)(1) of this paragraph,
the employer shall ensure that labels of
containers of contaminated protective
clothing and equipment include the
following information:
CONTAMINATED WITH COKE
EMISSIONS
MAY CAUSE CANCER
DO NOT EAT, DRINK, OR SMOKE
DO NOT REMOVE DUST BY BLOWING
OR SHAKING
*
*
*
*
*
23. Amend § 1910.1043 to revise
paragraph (j) as follows:
§ 1910.1043
Cotton dust.
srobinson on DSKHWCL6B1PROD with PROPOSALS2
*
WEAR RESPIRATORY PROTECTION IN
THIS AREA
*
*
*
*
*
24. Amend § 1910.1044 to revise
paragraphs (j)(2)(v), (k)(1)(iii)(b), and (o)
to read as follows:
§ 1910.1044
*
*
*
(j) * * *
(2) * * *
VerDate Nov<24>2008
1,2-dibromo-3-chloropropane.
*
*
23:10 Sep 29, 2009
Jkt 217001
AUTHORIZED PERSONNEL ONLY
(3) The employer shall ensure that the
precautionary labels required by this
paragraph are readily visible and
legible.
*
*
*
*
*
25. Amend § 1910.1045 to revise
paragraphs (p)(1)(i), (p)(2)(i), and (p)(3)
to read as follows:
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§ 1910.1045
50437
Acrylonitrile.
*
*
*
*
*
(p) Communication of hazards. (1)
General. (i) Hazard communication. The
employer shall include AN in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of AN and to safety
data sheets, and is trained in accordance
with the provisions of HCS and
paragraph (o) of this section. The
employer shall ensure that at least the
following hazards are addressed:
Cancer; central nervous system effects;
liver effects, skin sensitization, skin,
respiratory, and eye irritation; acute
toxicity effects; and flammability.
*
*
*
*
*
(2) Signs. (i) The employer shall post
signs to clearly indicate all workplaces
where AN concentrations exceed the
permissible exposure limits. The signs
shall bear the following legend:
DANGER
ACRYLONITRILE (AN)
MAY CAUSE CANCER
RESPIRATORY PROTECTION MAY BE
REQURED IN THIS AREA
AUTHORIZED PERSONNEL ONLY
*
*
*
*
*
(3) Labels. The employer shall ensure
that precautionary labels are affixed to
all containers of liquid AN and ANbased materials not exempted under
paragraph (a)(2) of this section. The
employer shall ensure that the labels
remain affixed when the materials are
sold, distributed, or otherwise leave the
employer’s workplace.
*
*
*
*
*
26. Amend § 1910.1047 to revise the
heading of paragraph (j) and paragraphs
(j)(1) and (j)(2) to read as follows:
§ 1910.1047
*
Ethylene oxide.
*
*
*
*
(j) Communication of hazards. (1)
Hazard communication. The employer
shall include EtO in the program
established to comply with the Hazard
Communication Standard (HCS) (29
CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of EtO and to safety
data sheets, and is trained in accordance
with the provisions of HCS and
paragraph (j)(3) of this section. The
employer shall ensure that at least the
following hazards are addressed:
Cancer; reproductive effects;
mutagenicity; central nervous system;
skin sensitization; skin, eye and
respiratory tract irritation; acute toxicity
effects; and flammability.
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(2) Signs and labels.
(i) Signs. The employer shall post and
maintain legible signs demarcating
regulated areas and entrances or access
ways to regulated areas that bear the
following legend:
DO NOT GET ON SKIN
exceeding 0.1 ppm, in the hazard
communication program.
(ii) In making the determinations of
anticipated levels of formaldehyde
release, the employer may rely on
objective data indicating the extent of
potential formaldehyde release under
reasonably foreseeable conditions of
use.
(2) In addition to the requirements in
paragraphs (m)(1) introductory text and
(m)(1)(i) of this section, for materials
listed in paragraph (m)(1)(i) of this
section capable of releasing
formaldehyde at levels above 0.5 ppm,
labels shall appropriately address all
hazards as defined in paragraph (d) of
§ 1910.1200 and Appendices A and B to
§ 1910.1200, including cancer and
respiratory sensitization, and shall
contain the hazard statement ‘‘may
cause cancer.’’
*
*
*
*
*
28. Amend § 1910.1050 as follows:
A. Revise paragraph (i)(2)(v) and the
heading of paragraph (k);
B. Revise paragraphs (k)(1) and (k)(2);
C. Redesignate paragraphs (k)(3) and
(k)(4) as (k)(4) and (k)(5);
D. Add a new paragraph (k)(3).
The revisions and additions read as
follows:
*
§ 1910.1050
(A) Signs. Storage areas for
contaminated clothing and equipment
shall have signs bearing the following
legend:
DANGER
DANGER
FORMALDEHYDE-CONTAMINATED
[CLOTHING] EQUIPMENT
ETHYLENE OXIDE
MAY CAUSE CANCER
MAY CAUSE CANCER
CAUSES SKIN, EYE AND
RESPIRATORY IRRITATION
MAY DAMAGE FERTILITY OR THE
UNBORN CHILD
DO NOT BREATHE VAPOR
RESPIRATORY PROTECTION AND
PROTECTIVE CLOTHING MAY BE
REQUIRED IN THIS AREA
AUTHORIZED PERSONNEL ONLY
(ii) Labels. The employer shall ensure
that labels are affixed to all containers
of EtO whose contents are capable of
causing employee exposure at or above
the action level or whose contents may
reasonably be foreseen to cause
employee exposure above the excursion
limit, and that the labels remain affixed
when the containers of EtO leave the
workplace. For the purposes of this
paragraph, reaction vessels, storage
tanks, and pipes or piping systems are
not considered to be containers.
Note to paragraph (j)(2): The labeling
requirements under this section do not apply
where EtO is used as a pesticide, as such
term is defined in the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. 136
et seq.), when it is labeled pursuant to that
Act and regulations issued under that Act by
the Environmental Protection Agency.
*
*
*
*
*
27. Amend § 1910.1048 to revise
paragraphs (e)(1); (h)(2)(ii); (j)(4) and (m)
to read as follows:
§ 1910.1048
Formaldehyde.
*
*
*
*
*
(e) * * *
(1) The employer shall establish
regulated areas where the concentration
of airborne formaldehyde exceeds either
the TWA or the STEL and post all
entrances and access ways with signs
bearing the following legend:
DANGER
FORMALDEHYDE
MAY CAUSE CANCER
srobinson on DSKHWCL6B1PROD with PROPOSALS2
CAUSES SKIN, EYE, AND
RESPIRATORY IRRITATION
AUTHORIZED PERSONNEL ONLY
*
*
*
*
*
(h) * * *
(2) * * *
(ii) When formaldehyde-contaminated
clothing and equipment is ventilated,
the employer shall establish storage
areas so that employee exposure is
minimized.
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DO NOT GET ON SKIN
(B) Labels. The employer shall ensure
containers for contaminated clothing
and equipment and storage areas are
labeled in accordance with the Hazard
Communication standard, 29 CFR
1910.1200, and shall, as a minimum,
include the following:
DANGER
FORMALDEHYDE-CONTAMINATED
[CLOTHING] EQUIPMENT
MAY CAUSE CANCER
CAUSES SKIN, EYE, AND
RESPIRATORY IRRITATION
DO NOT BREATHE VAPOR
*
*
*
*
(j) * * *
(4) Formaldehyde-contaminated waste
and debris resulting from leaks or spills
shall be placed for disposal in sealed
containers bearing a label warning of
formaldehyde’s presence and of the
hazards associated with formaldehyde.
The employer shall ensure that the
labels are in accordance with paragraph
(m) of this section.
*
*
*
*
*
(m) Communication of hazards. (1)
Hazard communication. The employer
shall include formaldehyde in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of formaldehyde
and to safety data sheets, and is trained
in accordance with the provisions of
HCS and paragraph (n) of this section.
The employer shall ensure that at least
the following hazards are addressed:
Cancer; skin and respiratory
sensitization; eye, skin and respiratory
tract irritation; acute toxicity effects;
and flammability.
(i) The employer must include
chemicals and substances associated
with formaldehyde gas, all mixtures or
solutions composed of greater than 0.1
percent formaldehyde, and materials
capable of releasing formaldehyde into
the air at concentrations reaching or
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Sfmt 4702
Methylenedianiline.
*
*
*
*
*
(i) * * *
(2) * * *
(v) Containers of MDA-contaminated
protective work clothing or equipment,
which are to be taken out of change
rooms or the workplace for cleaning,
maintenance, or disposal, shall bear
labels warning of the hazards of MDA.
The employer shall ensure that labels
are consistent with requirements in
paragraph (k) of this section and that
labels include at least the following
information:
DANGER
CONTAINS METHYLENEDIANILINE
(MDA)
MAY CAUSE CANCER
CAUSES DAMAGE TO THE LIVER
*
*
*
*
*
(k) Communication of hazards.
(1) Hazard communication. The
employer shall include MDA in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of MDA and to
safety data sheets, and is trained in
accordance with the provisions of HCS
and paragraph (k)(4) of this section. The
employer shall ensure that at least the
following hazards are addressed:
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Cancer; liver effects; and skin
sensitization.
(2) Signs. The employer shall post and
maintain legible signs demarcating
regulated areas and entrances or access
ways to regulated areas that bear the
following legend:
DANGER
MDA
MAY CAUSE CANCER
CAUSES DAMAGE TO THE LIVER
RESPIRATORY PROTECTION AND
PROTECTIVE CLOTHING MAY BE
REQUIRED IN THIS AREA
AUTHORIZED PERSONNEL ONLY
(3) Safety data sheets (SDS). In
meeting the obligation to provide safety
data sheets, employers shall make
appropriate use of the information
found in Appendices A and B to
§ 1910.1050 .
*
*
*
*
*
29. Amend § 1910.1051 to revise
paragraph (l)(1) as follows:
§ 1910.1051
1,3-Butadiene.
*
*
*
*
*
(l) * * *
(1) Hazard communication. The
employer shall include BD in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of BD and to safety
data sheets, and is trained in accordance
with the provisions of HCS and
paragraph (l)(2) of this section. The
employer shall ensure that at least the
following hazards are addressed:
Cancer; eye and respiratory tract
irritation; center nervous system effects;
and flammability.
*
*
*
*
*
30. Amend § 1910.1052 to revise
paragraph (k) as follows:
§ 1910.1052
Methylene chloride.
srobinson on DSKHWCL6B1PROD with PROPOSALS2
*
*
*
*
*
(k) Hazard communication. The
employer shall include MC in the
workplace hazard communication
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of MC and to safety
data sheets, and is trained in accordance
with the provisions of HCS and
paragraph (l) of this section. The
employer shall provide information on
at least the following hazards: Cancer,
cardiac effects (including elevation of
carboxyhemoglobin), central nervous
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system effects, liver effects, and skin
and eye irritation.
*
*
*
*
*
31. Amend § 1910.1200 as follows:
A. Remove the word ‘‘material’’ before
the word ‘‘safety’’ in the phrase
‘‘material safety data sheet’’ wherever it
appears in paragraphs (b)(3)(ii) and (iv),
(b)(4)(ii) five times, (e)(1) introductory
text, (e)(1)(i), (e)(2)(i), (g)(heading), (g)(1)
two times, (g)(4), (6)(i) two times,
(g)(6)(ii) through (iv), (g)(7)(i) two times,
(g)(7)(ii), (g)(7)(iii) two times, (g)(7)(iv)
two times, (g)(7)(v) two times, (g)(7)(vi)
and (vii), (g)(8) two times, (g)(9), (g)(10),
(h)(l), (h)(2)(iii),and (i)(1)(ii);
B. Remove the following definitions
in paragraph (c) Combustible liquid,
Compressed gas, Explosive, Flammable,
Flashpoint, Hazard warning, Identity,
Material Data Safety Sheet (MSDS),
Organic peroxide, Oxidizer, Pyrophoric,
Unstable (reactive), and Water reactive;
C. Revise the following definitions in
paragraph (c) Chemical, Chemical
name, Health hazard, Label, Mixture,
Physical hazard, and Trade secret;
D. Revise the definition of the term
‘‘Hazardous chemical’’ and relocate it in
alphabetical order in paragraph (c).
E. Add the following definitions in
alphabetical order in paragraph (c) in
alphabetical order Classification,
Hazard category, Hazard class, Hazard
statement, Label element, Pictogram,
Precautionary statement, Product
identifier, Safety Data Sheet (SDS),
Signal word, Substance and
Unclassified Hazard;
F. Revise paragraphs (a)(1), (a)(2),
(b)(1), (d) (heading), (d)(1) through
(d)(3), (f), (g)(2), (g)(3), (g)(5), (g)(11),
(h)(3)(iv), (i)(1), (i)(1)(iii) and (iv), (i)(2),
(i)(3), (i)(3)(iii), (i)(7), (i)(7)(iii), (i)(7)(v),
(i)(9)(i), (i)(10)(i), (i)(10)(ii), (i)(11), and
(i)(13), and (j);
G. Remove Appendices A, B, and E to
§ 1910.1200; redesignate Appendix D to
§ 1910.1200 as Appendix E to
§ 1910.1200 and add new Appendices
A, B, C, D and F to § 1910.1200.
The revisions and additions read as
follows:
§ 1910.1200
Hazard communication.
(a) Purpose.
(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 3. The transmittal of
information is to be accomplished by
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means of comprehensive hazard
communication programs, which are to
include container labeling and other
forms of warning, safety data sheets and
employee training.
*
*
*
*
*
(2) This occupational safety and
health standard is intended to address
comprehensively the issue of classifying
the potential hazards of chemicals, and
communicating information concerning
hazards and appropriate protective
measures to employees, and to preempt
any legal requirements of a state, or
political subdivision of a state,
pertaining to this subject. Classifying
the potential hazards of chemicals and
communicating information concerning
hazards and appropriate protective
measures to employees, may include,
for example, but is not limited to,
provisions for: developing and
maintaining a written hazard
communication program for the
workplace, including lists of hazardous
chemicals present; labeling of
containers of chemicals in the
workplace, as well as of containers of
chemicals being shipped to other
workplaces; preparation and
distribution of safety data sheets to
employees and downstream employers;
and development and implementation
of employee training programs regarding
hazards of chemicals and protective
measures. Under section 18 of the Act,
no state or political subdivision of a
state may adopt or enforce, through any
court or agency, any requirement
relating to the issue addressed by this
Federal standard, except pursuant to a
Federally-approved state plan.
(b) * * *
(1) This section requires chemical
manufacturers or importers to classify
the hazards of chemicals which they
produce or import, and 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, and information and training. In
addition, this section requires
distributors to transmit the required
information to employers. (Employers
who do not produce or import
chemicals need only focus on those
parts of this rule that deal with
establishing a workplace program and
communicating information to their
workers.)
*
*
*
*
*
(c) * * *
Chemical means any substance, or
mixture of substances.
*
*
*
*
*
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Chemical name means the scientific
designation of a chemical in accordance
with the nomenclature system
developed by the International Union of
Pure and Applied Chemistry (IUPAC) or
the Chemical Abstracts Service (CAS)
rules of nomenclature, or a name that
will clearly identify the chemical for the
purpose of conducting a hazard
classification.
Classification means to identify the
relevant data regarding the hazards of a
chemical; review those data to ascertain
the hazards associated with the
chemical; and decide whether the
chemical will be classified as
hazardous, and the degree of hazard
where appropriate, by comparing the
data with the criteria for health and
physical hazards.
Hazard category means the division of
criteria within each hazard class, e.g.,
oral acute toxicity and flammable
liquids include 4 hazard categories.
These categories compare hazard
severity within a hazard class and
should not be taken as a comparison of
hazard categories more generally.
Hazard class means the nature of the
physical or health hazards, e.g.,
flammable solid, carcinogen, oral acute
toxicity.
Hazard statement means a statement
assigned to a hazard class and category
that describes the nature of the hazard(s)
of a chemical, including, where
appropriate, the degree of hazard.
Hazardous chemical means any
chemical which is classified as a
physical hazard or a health hazard, or
an unclassified hazard as defined in this
section.
*
*
*
*
*
Health hazard means a chemical that
is classified as posing one of the
following hazardous effects: acute
toxicity (any route of exposure); skin
corrosion or irritation; serious eye
damage or eye irritation; respiratory or
skin sensitization; germ cell
mutagenicity; carcinogenicity;
reproductive toxicity; specific target
organ toxicity (single or repeated
exposure); or aspiration hazard. The
criteria for determining whether a
chemical is classified as a health hazard
are detailed in Appendix A to
§ 1910.1200—Health Hazard Criteria.
*
*
*
*
*
Label means an appropriate group of
written, printed or graphic information
elements concerning a hazardous
chemical, that is affixed to, printed on,
or attached to the immediate container
of a hazardous chemical, or to the
outside packaging.
Label elements means the specified
pictogram, hazard statement, signal
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word and precautionary statement for
each hazard class and category.
Mixture means a combination or a
solution composed of two or more
substances in which they do not react.
Physical hazard means a chemical
that is classified as posing one of the
following hazardous effects: explosive;
flammable (gases, aerosols, liquids, or
solids); oxidizer (liquid, solid or gas);
self-reactive; pyrophoric (liquid or
solid); self-heating; organic peroxide;
corrosive to metal; gas under pressure;
or in contact with water emits
flammable gas. See Appendix B to
§ 1910.1200—Physical Hazard Criteria.
Pictogram means a composition that
may include a symbol plus other
graphic elements, such as a border,
background pattern, or color, that is
intended to convey specific information
about the hazards of a chemical. Eight
pictograms are designated under this
standard for application to a hazard
category.
Precautionary statement means a
phrase that describes recommended
measures that should be taken to
minimize or prevent adverse effects
resulting from exposure to a hazardous
chemical, or improper storage or
handling.
*
*
*
*
*
Product identifier means the name or
number used for a hazardous chemical
on a label or in the SDS. It provides a
unique means by which the user can
identify the chemical. The product
identifier used shall permit crossreferences to be made among the
required list of hazardous chemicals, the
label and the SDS.
*
*
*
*
*
Safety data sheet (SDS) means written
or printed material concerning a
hazardous chemical that is prepared in
accordance with paragraph (g) of this
section.
Signal word means a word used to
indicate the relative level of severity of
hazard and alert the reader to a potential
hazard on the label. The signal words
used in this section are ‘‘danger’’ and
‘‘warning.’’ ‘‘Danger’’ is used for the
more severe hazards, while ‘‘warning’’
is used for the less severe.
*
*
*
*
*
Substance means chemical elements
and their compounds in the natural
state or obtained by any production
process, including any additive
necessary to preserve the stability of the
product and any impurities deriving
from the process used, but excluding
any solvent which may be separated
without affecting the stability of the
substance or changing its composition.
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Trade secret means any confidential
formula, pattern, process, device,
information or compilation of
information that is used in an
employer’s business, and that gives the
employer an opportunity to obtain an
advantage over competitors who do not
know or use it. Appendix E to
§ 1910.1200—Definition of Trade Secret,
sets out the criteria to be used in
evaluating trade secrets.
Unclassified hazard means a chemical
for which there is scientific evidence
identified during the classification
process that it may pose an adverse
physical or health effect when present
in a workplace under normal conditions
of use or in a foreseeable emergency, but
the evidence does not currently meet
the specified criteria for physical or
health hazard classification in this
section. This does not include adverse
physical and health effects for which
there is a hazard class addressed in this
section.
*
*
*
*
*
(d) Hazard classification.
(1) Chemical manufacturers and
importers shall evaluate chemicals
produced in their workplaces or
imported by them to classify their
health and physical hazards in
accordance with this section. For each
chemical, the chemical manufacturer or
importer shall determine the hazard
classes, and the category of each class
that apply to the chemical being
classified. Employers are not required to
classify chemicals unless they choose
not to rely on the classification
performed by the chemical
manufacturer or importer for the
chemical to satisfy this requirement.
(2) Chemical manufacturers,
importers or employers classifying
chemicals shall identify and consider
the full range of available scientific
literature and other evidence concerning
the potential hazards. There is no
requirement to test the chemical to
determine how to classify its hazards.
Appendix A to § 1910.1200 shall be
consulted for classification of health
hazards, and Appendix B to § 1910.1200
shall be consulted for the classification
of physical hazards.
(3) Mixtures.
(i) Chemical manufacturers,
importers, or employers evaluating
chemicals shall follow the procedures
described in Appendixes A and B to
§ 1910.1200 to classify the hazards of
the chemicals, including determinations
regarding when mixtures of the
classified chemicals are covered by this
section.
(ii) A chemical manufacturer or
importer of a mixture shall be
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responsible for the accuracy of the
classification of the mixture even when
relying on the classifications for
individual ingredients received from the
ingredient manufacturers or importers
on the safety data sheets.
*
*
*
*
*
(f) Labels and other forms of warning.
(1) Labels on shipped containers. The
chemical manufacturer, importer, or
distributor shall ensure that each
container of classified hazardous
chemicals leaving the workplace is
labeled, tagged or marked with the
following information:
(i) Product identifier;
(ii) Signal word;
(iii) Hazard statement(s);
(iv) Pictogram(s);
(v) Precautionary statement(s); and,
(vi) Name, address, and telephone
number of the chemical manufacturer,
importer, or other responsible party.
(2) For unclassified hazards, the label
shall include the name of the chemical,
the name, address, and telephone
number of the manufacturer, importer,
or other responsible party, and, provide
as supplementary information, a
description of the unclassified hazards
and appropriate precautionary measures
to ensure the safe handling and use of
the chemical.
(3) The chemical manufacturer,
importer, or distributor shall ensure that
the information provided under (f)(1)(i)
through (v) is in accordance with
Appendix C, Allocation of Label
Elements, for each hazard class and
associated hazard category for the
hazardous chemical, prominently
displayed, and in English (other
languages may also be included if
appropriate).
(4) The chemical manufacturer,
importer, or distributor shall ensure that
the information provided under (f)(1)(ii)
through (iv) is located together on the
label, tag, or mark.
(5)(i) For solid metal (such as a steel
beam or a metal casting), solid wood, or
plastic items that are not exempted as
articles due to their downstream use, or
shipments of whole grain, the required
label may be transmitted to the
customer at the time of the initial
shipment, and need not be included
with subsequent shipments to the same
employer unless the information on the
label changes;
(ii) The label may be transmitted with
the initial shipment itself, or with the
safety data sheet that is to be provided
prior to or at the time of the first
shipment; and,
(iii) This exception to requiring labels
on every container of hazardous
chemicals is only for the solid material
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itself, and does not apply to hazardous
chemicals used in conjunction with, or
known to be present with, the material
and to which employees handling the
items in transit may be exposed (for
example, cutting fluids or pesticides in
grains).
(6) 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.
(7) Workplace labeling. Except as
provided in paragraphs (f)(8) and (f)(9)
of this section, the employer shall
ensure that each container of hazardous
chemicals in the workplace is labeled,
tagged or marked with either:
(i) The information specified under
(f)(1)(i) through (v) for labels on shipped
containers; or,
(ii) Product identifier and words,
pictures, symbols, or combination
thereof, which provide at least general
information regarding the hazards of the
chemicals, and which, in conjunction
with the other information immediately
available to employees under the hazard
communication program, will provide
employees with the specific information
regarding the physical and health
hazards of the hazardous chemical.
(8) The employer may use signs,
placards, process sheets, batch tickets,
operating procedures, or other such
written materials in lieu of affixing
labels to individual stationary process
containers, as long as the alternative
method identifies the containers to
which it is applicable and conveys the
information required by paragraph (f)(7)
of this section to be on a label. The
employer shall ensure the written
materials are readily accessible to the
employees in their work area
throughout each work shift.
(9) The employer is not required to
label portable containers into which
hazardous chemicals are transferred
from labeled containers, and which are
intended only for the immediate use of
the employee who performs the transfer.
For purposes of this section, drugs
which are dispensed by a pharmacy to
a health care provider for direct
administration to a patient are exempted
from labeling.
(10) The employer shall not remove or
deface existing labels on incoming
containers of hazardous chemicals,
unless the container is immediately
marked with the required information.
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50441
(11) The employer shall ensure that
workplace labels or other forms of
warning are legible, in English, and
prominently displayed on the container,
or readily available in the work area
throughout each work shift. Employers
having employees who speak other
languages may add the information in
their language to the material presented,
as long as the information is presented
in English as well.
(12) 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 three
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. 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.
*
*
*
*
*
(g) * * *
(2) The chemical manufacturer or
importer preparing the safety data sheet
shall ensure that it is in English
(although the employer may maintain
copies in other languages as well), and
includes the following section numbers
and headings, and associated
information under each heading, in the
order listed (See Appendix D to
§ 1910.1200—Safety Data Sheets, for the
specific content of each section of the
safety data sheet.)
(i) Section 1, Identification;
(ii) Section 2, Hazard(s) identification;
(iii) Section 3, Composition/
information on ingredients;
(iv) Section 4, First-aid measures;
(v) Section 5, Fire-fighting measures;
(vi) Section 6, Accidental release
measures;
(vii) Section 7, Handling and storage;
(viii) Section 8, Exposure controls/
personal protection;
(ix) Section 9, Physical and chemical
properties;
(x) Section 10, Stability and reactivity;
(xi) Section 11, Toxicological
information.
Note 1 to paragraph (g)(2): To be
consistent with the GHS, an SDS must also
include the following headings in this order:
Section 12, Ecological information;
Section 13, Disposal considerations;
Section 14, Transport information; and
Section 15, Regulatory information.
Note 2 to paragraph (g)(2): OSHA will not
be enforcing information requirements in
sections 12 through 15, as these areas are not
under its jurisdiction.
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(xii) Section 16, Other information,
including date of preparation or last
revision.
(g)(3) If no relevant information is
found for any sub-heading within a
section on the safety data sheet, the
chemical manufacturer, importer or
employer preparing the safety data sheet
shall mark it to indicate that no
applicable information was found.
*
*
*
*
*
(5) The chemical manufacturer,
importer or employer preparing the
safety data sheet shall ensure that the
information provided accurately reflects
the scientific evidence used in making
the hazard classification. If the chemical
manufacturer, importer or employer
preparing the safety data sheet becomes
newly aware of any significant
information regarding the hazards of a
chemical, or ways to protect against the
hazards, this new information shall be
added to the safety data sheet within
three months. If the chemical is not
currently being produced or imported
the chemical manufacturer or importer
shall add the information to the safety
data sheet before the chemical is
introduced into the workplace again.
*
*
*
*
*
(11) Safety data sheets shall also be
made readily available, upon request, to
designated representatives, the Assistant
Secretary, and the Director, in
accordance with the requirements of 29
CFR 1910.1020(e).
(h) * * *
(3) * * *
(iv) The details of the hazard
communication program developed by
the employer, including an explanation
of the labels received on shipped
containers and the workplace labeling
system used by the employer; the safety
data sheet, including the order of
information and how employees can
obtain and use the appropriate hazard
information.
(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 of the substance
in a mixture, from the safety data sheet,
provided that:
*
*
*
*
*
(iii) The safety data sheet indicates
that the specific chemical identity and/
or percentage of composition is being
withheld as a trade secret; and,
(iv) The specific chemical identity
and percentage is made available to
health professionals, employees, and
designated representatives in
accordance with the applicable
provisions of this paragraph.
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(2) Where a treating physician or
nurse determines that a medical
emergency exists and the specific
chemical identity and/or specific
percentage of composition 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 physician or nurse,
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 percentage
composition, otherwise permitted to be
withheld under paragraph (i)(1) of this
section, to a health professional (i.e.
physician, industrial hygienist,
toxicologist, epidemiologist, or
occupational health nurse) providing
medical or other occupational health
services to exposed employee(s), and to
employees or designated
representatives, if:
*
*
*
*
*
(iii) The request explains in detail
why the disclosure of the specific
chemical identity or percentage
composition is essential and that, in lieu
thereof, the disclosure of the following
information to the health professional,
employee, or designated representative,
would not satisfy the purposes
described in paragraph (i)(3)(ii) of this
section:
*
*
*
*
*
(7) If the chemical manufacturer,
importer, or employer denies a written
request for disclosure of a specific
chemical identity or percentage
composition, the denial must:
*
*
*
*
*
(iii) Include evidence to support the
claim that the specific chemical identity
or percent of composition is a trade
secret;
*
*
*
*
*
(v) Explain in detail how alternative
information may satisfy the specific
medical or occupational health need
without revealing the trade secret.
*
*
*
*
*
(9) * * *
(i) The chemical manufacturer,
importer, or employer has supported the
claim that the specific chemical identity
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or percentage composition is a trade
secret;
*
*
*
*
*
(10) * * *
(i) If OSHA determines that the
specific chemical identity or percentage
composition requested under paragraph
(i)(3) of this section is not a ‘‘bona fide’’
trade secret, or that it is a trade secret,
but the requesting health professional,
employee, or designated representative
has a legitimate medical or occupational
health need for the information, has
executed a written confidentiality
agreement, and has shown adequate
means to protect the confidentiality of
the information, the chemical
manufacturer, importer, or employer
will be subject to citation by OSHA.
(ii) If a chemical manufacturer,
importer, or employer demonstrates to
OSHA that the execution of a
confidentiality agreement would not
provide sufficient protection against the
potential harm from the unauthorized
disclosure of a trade secret, the
Assistant Secretary may issue such
orders or impose such additional
limitations or conditions upon the
disclosure of the requested chemical
information as may be appropriate to
assure that the occupational health
services are provided without an undue
risk of harm to the chemical
manufacturer, importer, or employer.
*
*
*
*
*
(11) If a citation for a failure to release
trade secret information is contested by
the chemical manufacturer, importer, or
employer, the matter will be adjudicated
before the Occupational Safety and
Health Review Commission in
accordance with the Act’s enforcement
scheme and the applicable Commission
rules of procedure. In accordance with
the Commission rules, when a chemical
manufacturer, importer, or employer
continues to withhold the information
during the contest, the Administrative
Law Judge may review the citation and
supporting documentation ‘‘in camera’’
or issue appropriate orders to protect
the confidentiality of such matters.
*
*
*
*
*
(13) Nothing in this paragraph (i) shall
be construed as requiring the disclosure
under any circumstances of process
information which is a trade secret.
(j) Effective dates. (1) Employers shall
train employees regarding the new
labels and safety data sheets by [date 2
years after the publication of the final
rule].
(2) Chemical manufacturers,
importers, distributors, and employers
shall be in compliance with all modified
provisions of this section no later than
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[date 3 years after the publication of the
final rule].
(3) Chemical manufacturers,
importers, distributors, and employers
may comply with either 29 CFR
1910.1200 revised as of October 1, 2009,
or the modified version of this standard,
or both during the 3-year transition
period.
Appendix A to § 1910.1200—Health
Hazard Criteria (Mandatory)
A.0 GENERAL CLASSIFICATION
CONSIDERATIONS
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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.0.2 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 procedures.
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.
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
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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 assembled
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 wellconducted 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 assembled 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 For most hazard classes, the
recommended 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 that 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;
For health hazards,
(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
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50443
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
concentration limits).
A.0.4.2 An exception to the above order
or precedence is made for Carcinogenicity,
Germ Cell Mutagenicity, and Reproductive
Toxicity. For these three hazard classes,
mixtures shall be classified based upon
information on the ingredient substances,
unless on a case-by-case basis, justification
can be provided for classifying based upon
the mixture as a whole. See chapters A.5,
A.6, and A.7 for further information on caseby-case bases.
A.0.4.3 Use of Concentration Limits
A.0.4.3.1 When classifying an untested
mixture based on the hazards of its
ingredients, concentration limits for the
classified ingredients of the mixture are used
for several hazard classes. While the adopted
concentration limits adequately identify the
hazard for most mixtures, there may be some
that contain hazardous ingredients at lower
concentrations than the specified
concentration limits that still pose an
identifiable hazard. There may also be cases
where the concentration limit is considerably
lower than could be expected on the basis of
an 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 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 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.
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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
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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 commercial
product, when produced by or under the
control of the same 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.8, A.9, or A.10 of this
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Appendix, if a tested mixture is classified in
Category 1, and the concentration of the
ingredients of the tested mixture that are in
Category 1 is increased, the resulting
untested mixture shall be classified in
Category 1.
A.0.5.1.4
Category
Interpolation Within One Toxicity
For mixtures classified in accordance with
A.1, A.2, A.3, 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
toxicity 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
toxicity 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.,
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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 those 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.
A.1.2 Classification Criteria for Substances
A.1.2.1 Substances can be allocated to
one of four toxicity 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). See the
footnotes following Table A.1.1 for further
explanation on the application of these
values.
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A.1.2.3 The preferred test species for
evaluation of acute toxicity by the oral and
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inhalation routes is the rat, while the rat or
rabbit are preferred for evaluation of acute
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dermal toxicity. Test data already generated
for the classification of chemicals under
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.
A.1.3.2 Classification of mixtures for
acute toxicity can be carried out for each
route of exposure, but is only needed 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 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.1.3.6.2.3.
(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.1.3.6.2.3.
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A.1.3 Classification Criteria for Mixtures
A.1.3.1 The approach to classification of
mixtures for acute toxicity is tiered, and is
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.
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dependent upon the amount of information
available for the mixture itself and for its
ingredients. The flow chart of Figure A.1.1
indicates the process that must be followed:
A.1.3.5 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 toxicity 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 categories;
(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
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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.1.3.6.2.3.’’.
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:
100
Ci
=∑
ATEmix n ATE i
toxicity estimate. In this situation the
mixture is classified based on the known
ingredients only. (Note: A statement that ×
percent of the mixture consists of
ingredient(s) of unknown toxicity is required
on the label and safety data sheet in such
cases; see Appendix C, Allocation of Label
Elements and Appendix D, Safety Data
Sheets.)
A.1.3.6.2.4 If the total concentration of
the 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 ingredient(s) with
unknown toxicity is > 10%, the formula
presented in A.1.3.6.1 is corrected to adjust
for the total percentage of the unknown
ingredient(s) as follows:
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100 − ( ∑ Cunknown if >10% )
n
Ci
ATE i
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ATE mix
=∑
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Where:
Ci = concentration of ingredient i
n ingredients and i is running from l 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.1.3.6.2.3.
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%, the mixture
cannot be attributed a definitive acute
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A.2
scars. Histopathology should be considered
to evaluate questionable lesions.
Skin irritation is the production of
reversible damage to the skin following the
application of a test substance for up to 4
hours.
SKIN CORROSION/IRRITATION
A.2.1 Definitions
Skin corrosion is the production of
irreversible damage to the skin; namely,
visible necrosis through the epidermis and
into the dermis, following the application of
a test substance for up to 4 hours. Corrosive
reactions are typified by ulcers, bleeding,
bloody scabs, and, by the end of observation
at 14 days, by discoloration due to blanching
of the skin, complete areas of alopecia, and
A.2.2 Classification Criteria for Substances
Using Test Data
A.2.2.1 Corrosion
A.2.2.2 A single harmonized corrosion
category is provided in Table A.2.1, using the
results of animal testing. A corrosive is a
substance that produces destruction of skin
tissue, namely, visible necrosis through the
epidermis and into the dermis, in at least 1
of 3 tested animals after exposure up to a 4
hour duration. Corrosive reactions are
typified by ulcers, bleeding, bloody scabs
and, by the end of observation at 14 days, by
discoloration due to blanching of the skin,
complete areas of alopecia and scars.
Histopathology should be considered to
discern questionable lesions.
A.2.2.3 Three sub-categories of Category 1
are provided in Table A.2.1, all of which will
be regulated as Category 1.
TABLE A.2.1—SKIN CORROSION CATEGORY AND SUB-CATEGORIES a
Corrosive in ≥ 1 of 3 animals
Corrosive subcategories
Exposure
1A ..........................
1B ..........................
1C ..........................
≤ 3 min ..................
> 3 min ≤ 1 h ........
> 1 h ≤ 4 h ............
Category 1: Corrosive
a The
Observation
≤ 1 h.
≤ 14 days.
≤ 14 days.
use of human data is discussed in Appendix A.0.2.6.
A.2.3 Irritation
A.2.3.1 A single irritant category
(Category 2) is presented in the Table A.2.2.
The major criterion for the irritant category
is that at least 2 tested animals have a mean
score of ≥ 2.3 ≤ 4.0.
TABLE A.2.2—SKIN IRRITATION CATEGORY a
Criteria
Irritant (Category 2) ..............
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a The
(1) Mean value of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema 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.
use of human data is discussed in Appendix A.0.
A.2.3.2 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 fulfil this
criterion. However, it should be ascertained
that the responses are the result of chemical
exposure. Addition of this criterion increases
the sensitivity of the classification system.
A.2.3.3 Reversibility of skin lesions is
another consideration in evaluating irritant
responses. When inflammation persists to the
end of the observation period in 2 or more
test animals, taking into consideration
alopecia (limited area), hyperkeratosis,
hyperplasia and scaling, then a material
should be considered to be an irritant.
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A.2.4 Classification Criteria for Substances
Using Other Data Elements
A.2.4.1 Several factors must be
considered in determining the corrosion and
irritation potential of substances when no
clear data exist for those substances:
• Solid substances (powders) may become
corrosive or irritant when moistened or in
contact with moist skin or mucous
membranes.
• Existing human experience and data
including from single or repeated exposure
and animal observations and data shall be the
first line of analysis, as they give information
directly relevant to effects on the skin.
• In some cases enough information may
be available from structurally related
compounds to make classification decisions.
• pH extremes ≤ 2 and ≥ 11.5 may indicate
skin effects, especially when buffering
capacity is known, although the correlation
is not perfect. Generally, such agents are
expected to produce significant effects on the
skin.
• If a chemical is highly toxic by the
dermal route, data from dermal testing for
skin irritation/corrosion may not be available
since the amount of test substance to be
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applied would considerably exceed the toxic
dose and, consequently, would result in the
death of the animals.
• In vitro alternatives that have been
validated and accepted may also be used to
help make classification decisions.
All the above information that is available
on a substance shall be evaluated. Although
information might be gained from the
evaluation of single parameters within a tier
(see A.2.4), there is merit in considering the
totality of existing information and making
an overall weight of evidence determination.
This is especially true when there is
information available on some but not all
parameters. Primary emphasis shall be
placed upon existing human experience and
data, followed by animal experience and
testing data, followed by other sources of
information, but case-by-case determinations
are necessary.
A.2.4.2 A tiered approach to the
evaluation of initial information shall be
considered, where applicable (Figure A.2.1),
recognizing that all elements may not be
relevant in certain cases.
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A.2.5 Classification Curiteria for
Mixtures
A.2.5.1 Classification of Mixtures
When Data Are Available for the
Complete Mixture
A.2.5.1.1 The mixture shall be
classified using the criteria for
substances (see A.2.2 to A.2.4).
A.2.5.2 Classification of Mixtures
When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.2.5.2.1 Where the mixture itself
has not been tested to determine its skin
irritation/corrosion, 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
toxicity category, Substantially similar
mixtures, and Aerosols.
A.2.5.3 Classification of Mixtures
When Data Are Available for All
Ingredients or Only for Some
Ingredients of the Mixture
A.2.5.3.1 In order to make use of all
available data for purposes of classifying
the skin irritation/corrosion 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% (w/w for solids,
liquids, dusts, mists and vapors and v/
v for gases), unless there is a
presumption (e.g. in the case of
corrosive ingredients) that an ingredient
present at a concentration < 1% can still
be relevant for classifying the mixture
for skin irritation/corrosion.
A.2.5.3.2 In general, the approach to
classification of mixtures as irritant or
corrosive to 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 irritant or
corrosive 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.2.5.3.3 Table A.2.3 below
provides the cut-off value/concentration
limits to be used to determine if the
mixture is considered to be an irritant
or a corrosive to the skin.
A.2.5.3.4 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.2.5.3.1 and A.2.5.3.2 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 of 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
Category 1 if it contains ≥ 1% of a
corrosive ingredient and as skin
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.2.5.3.5 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 concentration cut-off values
mentioned in Tables 3.2.3 and 3.2.4. In
these cases the mixture could be
classified according to those data (see
Use of concentration limits, paragraph
A.0.4.3 of this Appendix).
A.2.5.3.6 If there are data showing
that (an) ingredient(s) may be corrosive
or irritant at a concentration of < 1%
(corrosive) or < 3% (irritant), the
mixture shall be classified accordingly
(see Use of 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 irritant
Skin corrosive
Category 1
Skin Category 1 .......................................................................................................................................
Skin Category 2 .......................................................................................................................................
(10 × Skin Category 1) + Skin Category 2 ..............................................................................................
≥ 5% ......................
................................
................................
≥ 1% but < 5%.
≥ 10%.
≥ 10%.
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
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Ingredient:
Concentration:
Mixture classified
as: Skin
Acid with pH ≤ 2 ......................................................................................................................................
Base with pH ≥ 11.5 ................................................................................................................................
Other corrosive (Category 1) ingredients for which additivity does not apply ........................................
Other irritant (Category 2) ingredients for which additivity does not apply, including acids and bases
≥
≥
≥
≥
Category
Category
Category
Category
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1%
1%
1%
3%
......................
......................
......................
......................
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A.3 SERIOUS EYE DAMAGE /EYE
IRRITATION
A.3.2 Classification Criteria for Substances
Using Test Data
A.3.1 Definitions
Serious eye damage is the production of
tissue damage in the eye, or serious physical
decay of vision, following application of a
test substance to the anterior surface of the
eye, which is not fully reversible within 21
days of application.
Eye irritation is the production of changes
in the eye following the application of test
substance to the anterior surface of the eye,
which are fully reversible within 21 days of
application.
A.3.2.1 Irreversible Effects on the Eye/
Serious Damage to Eyes (Category 1)
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
A.3.2.2 Reversible Effects on the Eye
(Category 2)
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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 or iritis > 1.5 detected in
a Draize eye test with rabbits, because severe
lesions like these usually do not reverse
within a 21-day observation period.
potential to induce reversible eye
irritation.
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A single category is provided in Table
A.3.2 for substances that have the
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For those chemicals where there is
pronounced variability among animal
responses, this information may be
taken into account in determining the
classification.
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A.3.3 Classification Criteria for
Substances Using Other Data Elements
A.3.3.1 A tiered evaluation scheme
that combines pre-existing information
on serious ocular tissue damage and on
eye irritation (including data relating to
historical human or animal experience)
as well as considerations on structureactivity relationships (SAR) or structureproperty relationships (SPR) and the
output of validated in vitro tests shall be
used for substances where no clear test
data exist for those substances:
A.3.3.2 All existing information on a
substance shall be reviewed and several
factors considered in determining the
serious eye damage or irritation
potential of substances:
• Accumulated human and animal
data shall be the first line of analysis, as
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it gives information directly relevant to
effects on the eye.
• In some cases enough information
may be available from structurally
related compounds to make hazard
decisions.
• Likewise, pH extremes like ≥ 2 and
> 11.5 may produce serious eye damage,
especially when associated with
significant buffering capacity. Such
agents are expected to produce
significant effects on the eyes.
• Possible skin corrosion has to be
evaluated prior to consideration of
serious eye damage/eye irritation in
order to avoid testing for local effects on
eyes with skin corrosive substances.
• In vitro alternatives that have been
validated and accepted may be used to
make classification decisions.
A.3.3.3 All the above information
that is available on a substance shall be
evaluated. Although information might
be gained from the evaluation of single
parameters within a tier, there is merit
in considering the totality of existing
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information and making an overall
weight of evidence determination. This
is especially true when there is
information available on some but not
all parameters. Generally, primary
emphasis shall be placed upon expert
judgment, considering human
experience with the substance, followed
by the outcome of skin irritation testing
and of well validated alternative
methods.
A.3.3.4 A tiered approach to the
evaluation of initial information shall be
considered where applicable,
recognizing that all elements may not be
relevant in certain cases (Figure A.3.1).
A.3.3.5 The proposed tiered testing
approach provides good guidance on
how to organize existing information on
a substance and to make a weight-ofevidence decision, where appropriate,
about hazard assessment and hazard
classification.
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toxicity category, Substantially similar
mixtures, and Aerosols.
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
testing and evaluation strategies used to
develop data for these hazard classes.
A.3.4.1.2 Unlike other hazard
classes, there are alternative tests
available for skin corrosivity of certain
types of chemicals that can give an
accurate result for classification
purposes, as well as being simple and
relatively inexpensive to perform. When
considering testing of the mixture,
manufacturers are encouraged to use a
tiered weight of evidence strategy 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 avoid unnecessary animal
testing. A mixture is considered to cause
serious eye damage (Eye Category 1) if
it has a pH ≤ 2 or ≥ 11.5. If consideration
of alkali/acid reserve suggests the
substance or mixture may not have the
potential to cause serious eye damage
despite the low or high pH value, then
further testing needs to be carried out to
confirm this, preferably by use of an
appropriate validated in vitro test.
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 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
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 In order to make use of all
available data for purposes of classifying
the eye irritation/serious eye damaging
properties of the 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% (w/w for solids,
liquids, dusts, mists and vapours and
v/v for gases), unless there is a
presumption (e.g., in the case of
corrosive ingredients) that an ingredient
present at a concentration < 1% can still
be relevant for classifying the mixture
for eye irritation/serious eye damage.
A.3.4.3.2 In general, the approach to
classification of mixtures as eye irritant
or seriously damaging to the eye 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 irritant or
corrosive 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 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 should
be classified an irritant or as seriously
damaging to the eye.
A.3.4.3.4 Particular care must be
taken when classifying certain types of
chemicals such as acids and bases,
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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
corrosive or irritant 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 than the
concentration limits of Table A.3.3. A
mixture containing corrosive or irritant
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 Eye
Category 1 if it contains ≥ 1% of a
corrosive ingredient and as Eye Category
2 when it contains ≥ 3% of an 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 reversible/
irreversible 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 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
strategy 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
or irritant at a concentration of < 1%
(corrosive) or < 3% (irritant), the
mixture should be classified accordingly
(see also paragraph A.0.4.3,Use of
concentration limits).
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TABLE A.3.3—CONCENTRATION OF INGREDIENTS OF A MIXTURE CLASSIFIED AS SKIN CATEGORY 1 AND/OR EYE
CATEGORY 1 OR 2 THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURES AS HAZARDOUS TO THE EYE
Concentration triggering classification of
a mixture as:
Sum of ingredients classified as:
Irreversible eye
effects
Category 1
Eye or skin Category 1 ............................................................................................................................
Eye Category 2 ........................................................................................................................................
(10 × eye Category 1) + eye Category 2 ................................................................................................
Skin Category 1 + eye Category 1 ..........................................................................................................
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Reversible eye
effects
Category 2
≥ 3% ......................
................................
................................
≥ 3% ......................
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≥
≥
≥
≥
1% but < 3%.
10%.
10%.
1% but < 3%.
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TABLE A.3.3—CONCENTRATION OF INGREDIENTS OF A MIXTURE CLASSIFIED AS SKIN CATEGORY 1 AND/OR EYE
CATEGORY 1 OR 2 THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURES AS HAZARDOUS TO THE EYE—Continued
Concentration triggering classification of
a mixture as:
Sum of ingredients classified as:
Irreversible eye
effects
Category 1
10 × (skin Category 1 + eye Category 1) + eye Category 2 ..................................................................
Reversible eye
effects
Category 2
................................
≥ 10%.
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
Ingredient:
Acid with pH ≤ 2 ......................................................................................................................................
Base with pH ≥ 11.5 ................................................................................................................................
Other corrosive (Category 1) ingredients for which additivity does not apply ........................................
Other irritant (Category 2) ingredients for which additivity does not apply, including acids and bases
A.4 RESPIRATORY OR SKIN
SENSITIZATION
A.4.1 Definitions and General
Considerations
A.4.1.1 Respiratory sensitizer means a
chemical that will lead to hypersensitivity of
the airways following inhalation of the
chemical.
Skin sensitizer means a chemical that will
lead to an allergic response following skin
contact.
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.
Mixture classified
as: Eye
Concentration
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.
≥
≥
≥
≥
1%
1%
1%
3%
......................
......................
......................
......................
Category
Category
Category
Category
1.
1.
1.
2.
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.
TABLE A.4.1—HAZARD CATEGORY AND SUB-CATEGORIES FOR RESPIRATORY SENSITIZERS
Category 1:
Respiratory sensitizer
Sub-category 1A ..................
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.19
Substances showing a high frequency of occurrence in humans; or a probability of occurrence of a high sensitization rate in humans based on animal or other tests.1 Severity of reaction may also be considered.
Substances showing a low to moderate frequency of occurrence in humans; or a probability of occurrence of a
low to moderate sensitization rate in humans based on animal or other tests.1 Severity of reaction may also be
considered.
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Sub-category 1B ..................
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.
19 At this writing, recognized and validated
animal models for the testing of respiratory
hypersensitivity are not available. Under certain
circumstances, data from animal studies may
provide valuable information in a weight of
evidence assessment.
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In this context, hypersensitivity is normally
seen as asthma, but other hypersensitivity
reactions such as rhinitis/conjunctivitis and
alveolitis are also considered. The condition
will have the clinical character of an allergic
reaction. However, immunological
mechanisms do not have to be demonstrated.
A.4.2.1.2.2 When considering the human
evidence, it is necessary that in addition to
the evidence from the cases, the following be
taken into account:
(a) the size of the population exposed;
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(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);
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(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 1 which may be indicative of the
potential of a substance to cause sensitization
by inhalation in humans 20 may include:
(a) measurements of Immunoglobulin E
(IgE) and other specific immunological
parameters, for example in mice;
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(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.
TABLE A.4.2—HAZARD CATEGORY AND SUB-CATEGORIES FOR SKIN SENSITIZERS
Category 1:
Skin sensitizer
Sub-category 1A
A substance is classified as a skin sensitizer:
(a) if there is evidence in humans that the substance can lead to sensitization by skin contact in a substantial number of
persons, or
(b) if there are positive results from an appropriate animal test.
Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have
the potential to produce significant sensitization in humans. Severity of reaction may also be considered.
Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can
be presumed to have the potential to produce sensitization in humans. Severity of reaction may also be considered.
Sub-category 1B
A.4.2.2.2
Human Evidence
A.4.2.2.2.1 Human evidence for subcategory 1A may include:
(a) positive responses at ≤500 μg/cm2
(HRIPT, HMT—induction threshold);
(b) diagnostic patch test data where there
is a relatively high and substantial incidence
of reactions in a defined population in
relation to relatively low exposure;
(c) other epidemiological evidence where
there is a relatively high and substantial
incidence of allergic contact dermatitis in
relation to relatively low exposure.
A.4.2.2.2.2 Human evidence for subcategory 1B may include:
(a) positive responses at >500 μg/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.21
A.4.2.2.3.2 Animal test results for subcategory 1A can include data with values
indicated in Table A.4.3.
TABLE A.4.3—ANIMAL TEST RESULTS FOR SUB-CATEGORY 1A
Assay
Local lymph node assay ......
Guinea pig maximization test
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Criteria
EC3 value ≤2%.
≥30% responding
≥60% responding
≥15% responding
≥60% responding
at
at
at
at
≤0.1% intradermal induction dose or
>0.1% to ≤1% intradermal induction dose.
≤0.2% topical induction dose or
>0.2% to ≤20% topical induction dose.
A.4.2.2.3.3 Animal test results for subcategory 1B can include data with values
indicated in Table A.4.4 below:
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.
20 The mechanisms by which substances induce
symptoms of asthma are not yet fully known. For
preventative measures, these substances are
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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
hyperreactivity, they should not be considered as
respiratory sensitizers.
21 Test methods for skin sensitization are
described in OECD Guideline 406 (the Guinea Pig
Maximization test and the Buehler guinea pig test)
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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.
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TABLE A.4.4—ANIMAL TEST RESULTS FOR SUB-CATEGORY 1B
Assay
Criteria
Local lymph
node assay.
Guinea pig
maximization
test.
EC3 value >2%.
≥30% to <60% responding at >0.1% to ≤1% intradermal induction dose or
Buehler assay ...
≥30% responding at >1% intradermal induction dose.
≥15% to <60% responding at >0.2% to ≤20% topical induction dose or
≥15% responding at >20% topical induction dose.
A.4.2.2.4 Specific Considerations
A.4.2.2.4.1 For classification of a
substance, evidence should include any or all
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 man (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 may also be
considered.
A.4.2.2.4.2 Evidence from animal studies
is usually much more reliable than evidence
from human exposure. However, in cases
where evidence is available from both
sources, and there is conflict between the
results, the quality and reliability of the
evidence from both sources must be assessed
in order to resolve the question of
classification on a case-by-case basis.
Normally, human data are not generated in
controlled experiments with volunteers for
the purpose of hazard classification but
rather as part of risk assessment to confirm
lack of effects seen in animal tests.
Consequently, positive human data on skin
sensitization are usually derived from casecontrol or other, less defined studies.
Evaluation of human data must, therefore, be
carried out with caution as the frequency of
cases reflect, in addition to the inherent
properties of the substances, factors such as
the exposure situation, bioavailability,
individual predisposition and preventive
measures taken. Negative human data should
not normally be used to negate positive
results from animal studies. For both animal
and human data, consideration should be
given to the impact of vehicle.
A.4.2.2.4.3 If none of the abovementioned conditions are met, the substance
need not be classified as a skin sensitizer.
However, a combination of two or more
indicators of skin sensitization, as listed
below, may alter the decision. This shall be
considered on a case-by-case basis.
(a) Isolated episodes of allergic contact
dermatitis;
(b) Epidemiological studies of limited
power, e.g., where chance, bias or
confounders have not been ruled out fully
with reasonable confidence;
(c) Data from animal tests, performed
according to existing guidelines, which do
not meet the criteria for a positive result
described in A.4.2.2.3, but which are
sufficiently close to the limit to be
considered significant;
(d) Positive data from non-standard
methods;
(e) Positive results from close structural
analogues.
A.4.2.2.4.4 Immunological Contact Urticaria
A.4.2.2.4.4.1 Substances meeting the
criteria for classification as respiratory
sensitizers may, in addition, cause
immunological contact urticaria.
Consideration shall be given to classifying
these substances as skin sensitizers.
A.4.2.2.4.4.2 Substances which cause
immunological contact urticaria without
meeting the criteria for respiratory sensitizers
shall be considered for classification as skin
sensitizers.
A.4.2.2.4.4.3 There is no recognized
animal model available to identify substances
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 can 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,
Substantially similar mixtures, and Aerosols.
A.4.3.3 Classification of Mixtures When
Data are Available for all Ingredients or Only
for Some Ingredients of the Mixture
The mixture shall be classified as a
respiratory or skin sensitizer when at least
one ingredient has been classified as a
respiratory or skin sensitizer and is present
at or above the appropriate cut-off value/
concentration limit for the specific endpoint
as shown in Table A.4.5.
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TABLE A.4.5—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED AS EITHER
RESPIRATORY SENSITIZERS OR SKIN SENSITIZERS THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE
Cut-off values/concentration limits
triggering classification of a mixture as:
Ingredient classified as:
Respiratory sensitizer Category 1
Solid/Liquid
Respiratory sensitizer, Category 1 .......................................................................
Respiratory sensitizer, Sub-category 1A ..............................................................
Respiratory sensitizer, Sub-category 1B ..............................................................
Skin sensitizer, Category 1 ...................................................................................
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≥0.1% ....................
≥0.1% ....................
≥1.0% ....................
...............................
≥0.1%.
≥0.1%.
≥0.2%.
...............................
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TABLE A.4.5—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED AS EITHER
RESPIRATORY SENSITIZERS OR SKIN SENSITIZERS THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE—Continued
Cut-off values/concentration limits
triggering classification of a mixture as:
Ingredient classified as:
Respiratory sensitizer Category 1
Solid/Liquid
Skin sensitizer, Sub-category 1A .........................................................................
Skin sensitizer, Sub-category 1B .........................................................................
A.5
GERM CELL MUTAGENICITY
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A.5.1 Definitions and General
Considerations
A.5.1.1 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
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Gas
...............................
...............................
...............................
...............................
of mutations in populations of cells and/or
organisms.
A.5.1.2 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.5.1.3 This hazard class is primarily
concerned with chemicals that may cause
mutations in the germ cells of humans that
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Skin sensitizer
Category 1
All physical states
≥0.1%.
≥1.0%.
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.
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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.
22 It should be noted that the classification criteria
for the GHS usually include a tiered scheme in
which test data available on the complete mixture
are considered as the first tier in the evaluation,
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A.5.2.2.3 Classification for heritable
effects in human germ cells is made on the
basis of scientifically validated tests.1
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
followed by the applicable bridging principles, and
lastly, cut-off values/concentration or additivity.
However, this approach is not used for Germ Cell
Mutagenicity. These criteria for Germ Cell
Mutagenicity consider the cut-off levels 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.
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Classification Criteria for Mixtures 22
A.5.3.1 Classification of Mixtures When
Data Are Available for All Ingredients or
Only for Some Ingredients of the Mixture
A.5.3.1.1 Classification of mixtures shall
be based on the available test data for the
individual ingredients of the mixture using
cut-off values/concentration limits for the
ingredients classified as germ cell mutagens.
A.5.3.1.2 The mixture will be classified
as a mutagen when at least one ingredient
has been classified as a Category 1A,
Category 1B or Category 2 mutagen and is
present at or above the appropriate cut-off
value/concentration limit as shown in Table
A.5.1 below for Category 1 and 2
respectively.
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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 1A/B mutagen ..........................................................................................................................
Category 2 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).
As new, scientifically validated, tests arise,
these may also be used in the total weight of
evidence to be considered.
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.
Examples of in vivo heritable germ cell
mutagenicity tests are:
• Rodent dominant lethal mutation test
(OECD 478)
• Mouse heritable translocation assay
(OECD 485)
• Mouse specific locus test
Examples of in vivo somatic cell
mutagenicity tests are:
• Mammalian bone marrow chromosome
aberration test (OECD 475)
• Mouse spot test (OECD 484)
• Mammalian erythrocyte micronucleus
test (OECD 474)
Examples of mutagenicity/genotoxicity
tests in germ cells are:
(a) Mutagenicity tests:
a. Mammalian spermatogonial
chromosome aberration test (OECD 483)
b. Spermatid micronucleus assay
(b) Genotoxicity tests:
a. Sister chromatid exchange analysis in
spermatogonia
b. Unscheduled DNA synthesis test (UDS)
in testicular cells
Examples of genotoxicity tests in somatic
cells are:
• Liver Unscheduled DNA Synthesis
(UDS) in vivo (OECD 486)
• Mammalian bone marrow Sister
Chromatid Exchanges (SCE)
Examples of in vitro mutagenicity tests are:
• In vitro mammalian chromosome
aberration test (OECD 473)
• In vitro mammalian cell gene mutation
test (OECD 476)
• Bacterial reverse mutation tests (OECD
471)
23 See Non-mandatory Appendix F for further
guidance regarding hazard classification for
carcinogenicity. This appendix is consistent with
the GHS and is provided as guidance excerpted
from monographs of the International Agency for
Research on Cancer (IARC) Monographs programme
on the evaluation of the strength and evidence of
carcinogenic risks to humans.
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.
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A.5.3.3 Classification of Mixtures When
Data Are Not Available for the Complete
Mixture: Bridging Principles
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A.6
CARCINOGENICITY
A.6.1 Definitions
Carcinogen means a substance or a mixture
of substances which induce cancer or
increase its incidence. 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 23
A.6.2.1 For the purpose of classification
for carcinogenicity, substances are allocated
to one of two categories based on strength of
evidence and additional weight of evidence
considerations. In certain instances, routespecific classification may be warranted.
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A.6.2.2 Classification as a carcinogen is
made on the basis of evidence from reliable
and acceptable methods, and is intended to
be used for substances which have an
intrinsic property to produce such toxic
effects. The evaluations are to be based on all
existing data, peer-reviewed published
studies and additional data accepted by
regulatory agencies.
A.6.2.3 Carcinogen classification is a onestep, criterion-based process that involves
two interrelated determinations: Evaluations
of strength of evidence and consideration of
all other relevant information to place
substances with human cancer potential into
hazard categories.
A.6.2.4 Strength of evidence involves the
enumeration of tumors in human and animal
studies and determination of their level of
statistical significance. Sufficient human
evidence demonstrates causality between
human exposure and the development of
cancer, whereas sufficient evidence in
animals shows a causal relationship between
the agent and an increased incidence of
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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 Appendix F.)
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
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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;
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(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.
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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 24
A.6.3.1 The mixture shall be classified as
a carcinogen when at least one ingredient has
been classified as a Category 1 or Category 2
carcinogen and is present at or above the
appropriate cut-off value/concentration limit
as shown in Table A.6.1.
TABLE A.6.1—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED AS CARCINOGEN
THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE
Ingredient classified as:
Category 1
carcinogen
Category 1 carcinogen ............................................................................................................................
Category 2 carcinogen ............................................................................................................................
≥ 0.1% ...................
................................
Category 2
carcinogen
≥ 0.1% (note 1).
Note 1: If a Category 2 carcinogen ingredient is present in the mixture at a concentration between 0.1% and 1%, information is required on
the SDS for a product, however, a label warning is optional If a Category 2 carcinogen ingredient is present in the mixture at a concentration of ≥
1%, both an SDS and a label is required and the information must be included on each.
A.6.3.2 Classification of Mixtures When
Data Are Available for the Complete Mixture
A mixture may be classified based on the
available test data for the mixture as a whole.
In such cases, the test results for the mixture
as a whole must be shown to be conclusive
taking into account dose and other factors
such as duration, observations and analysis
(e.g., statistical analysis, test sensitivity) of
carcinogenicity test systems.
A.6.3.3 Classification of Mixtures When
Data Are Not Available for the Complete
Mixture: Bridging Principles
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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.
24 It should be noted that the classification criteria
for the GHS usually include a tiered scheme in
which test data available on the complete mixture
are considered as the first tier in the evaluation,
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A.7
REPRODUCTIVE TOXICITY
A.7.1 Definitions and General
Considerations
A.7.1.1 Reproductive toxicity includes
adverse effects on sexual function and
fertility in adult males and females, as well
as adverse effects on development of the
offspring. Some reproductive toxic effects
cannot be clearly assigned to either
impairment of sexual function and fertility or
to developmental toxicity. Nonetheless,
chemicals 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
followed by the applicable bridging principles, and
lastly, cut-off values/concentration or additivity.
However, this approach is not used for
Carcinogenicity. These criteria for Carcinogenicity
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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 lactation shall be
classified in a separate hazard category in
accordance with Figure A.7.1(b).
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consider the cut-off levels 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.
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A.7.2.2
Basis of Classification
A.7.2.2.1 Classification is made on the
basis of the criteria, outlined above, an
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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,
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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 assembled
together into 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
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classification may not necessarily be the
outcome. These effects include, for example,
small changes in semen parameters or in the
incidence of spontaneous defects in the fetus,
small changes in the proportions of common
fetal variants such as are observed in skeletal
examinations, or in fetal weights, or small
differences in postnatal developmental
assessments.
A.7.2.3.4 Data from animal studies shall
provide sufficient evidence of specific
reproductive toxicity in the absence of other
systemic toxic effects. However, if
developmental toxicity occurs together with
other toxic effects in the dam (mother), the
potential influence of the generalized adverse
effects should be assessed to the extent
possible. The preferred approach is to
consider adverse effects in the embryo/fetus
first, and then evaluate maternal toxicity,
along with any other factors which are likely
to have influenced these effects, as part of the
weight of evidence. In general,
developmental effects that are observed at
maternally toxic doses should not be
automatically discounted. Discounting
developmental effects that are observed at
maternally toxic doses can only be done on
a case-by-case basis when a causal
relationship is established or refuted.
A.7.2.3.5 If appropriate information is
available it is important to try to determine
whether developmental toxicity is due to a
specific maternally mediated mechanism or
to a non-specific secondary mechanism, like
maternal stress and the disruption of
homeostasis. Generally, the presence of
maternal toxicity should not be used to
negate findings of embryo/fetal effects, unless
it can be clearly demonstrated that the effects
are secondary non-specific effects. This is
especially the case when the effects in the
offspring are significant, e.g., irreversible
effects such as structural malformations. In
some situations it is reasonable to assume
that reproductive toxicity is due to a
secondary consequence of maternal toxicity
and discount the effects, for example if the
chemical is so toxic that dams fail to thrive
and there is severe inanition; they are
incapable of nursing pups; or they are
prostrate or dying.
A.7.2.4 Maternal Toxicity
A.7.2.4.1 Development of the offspring
throughout gestation and during the early
postnatal stages can be influenced by toxic
effects in the mother either through nonspecific mechanisms related to stress and the
disruption of maternal homeostasis, or by
specific maternally-mediated mechanisms.
So, in the interpretation of the developmental
outcome to decide classification for
developmental effects it is important to
consider the possible influence of maternal
toxicity. This is a complex issue because of
uncertainties surrounding the relationship
between maternal toxicity and
developmental outcome. Expert judgment
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
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factors which are likely to have influenced
these effects, as weight of evidence, to help
reach a conclusion about classification.
A.7.2.4.2 Based on pragmatic observation,
it is believed that maternal toxicity may,
depending on severity, influence
development via non-specific secondary
mechanisms, producing effects such as
depressed fetal weight, retarded ossification,
and possibly resorptions and certain
malformations in some strains of certain
species. However, the limited numbers of
studies which have investigated the
relationship between developmental effects
and general maternal toxicity have failed to
demonstrate a consistent, reproducible
relationship across species. Developmental
effects which occur even in the presence of
maternal toxicity are considered to be
evidence of developmental toxicity, unless it
can be unequivocally demonstrated on a case
by case basis that the developmental effects
are secondary to maternal toxicity. Moreover,
classification shall be considered where there
is a significant toxic effect in the offspring,
e.g., irreversible effects such as structural
malformations, embryo/fetal lethality, or
significant post-natal functional deficiencies.
A.7.2.4.3 Classification shall not
automatically be discounted for chemicals
that produce developmental toxicity only in
association with maternal toxicity, even if a
specific maternally-mediated mechanism has
been demonstrated. In such a case,
classification in Category 2 may be
considered more appropriate than Category 1.
However, when a chemical is so toxic that
maternal death or severe inanition results, or
the dams (mothers) are prostrate and
incapable of nursing the pups, it is
reasonable to assume that developmental
toxicity is produced solely as a secondary
consequence of maternal toxicity and
discount the developmental effects.
Classification is not necessarily the outcome
in the case of minor developmental changes,
e.g., a small reduction in fetal/pup body
weight or retardation of ossification when
seen in association with maternal toxicity.
A.7.2.4.4 Some of the endpoints used to
assess maternal toxicity are provided below.
Data on these endpoints, if available, shall be
evaluated in light of their statistical or
biological significance and dose-response
relationship.
(a) Maternal mortality: An increased
incidence of mortality among the treated
dams over the controls shall be considered
evidence of maternal toxicity if the increase
occurs in a dose-related manner and can be
attributed to the systemic toxicity of the test
material. Maternal mortality greater than
10% is considered excessive and the data for
that dose level shall not normally be
considered to need further evaluation.
(b) Mating index (Number of animals with
seminal plugs or sperm/Number of mated ×
100)
(c) Fertility index (Number of animals with
implants/Number of matings × 100)
(d) Gestation length (If allowed to deliver)
(e) Body weight and body weight change:
Consideration of the maternal body weight
change and/or adjusted (corrected) maternal
body weight shall be included in the
evaluation of maternal toxicity whenever
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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 useful indicators 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-
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generation toxicity testing (e.g., OECD Test
Guidelines 415, 416)
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 should 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
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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 25
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.
25 It should be noted that the classification criteria
for the GHS 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 or additivity.
However, this approach is not used for
Reproductive Toxicity. These criteria for
Reproductive Toxicity consider the cut-off levels 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.
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TABLE A.7.1—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED AS REPRODUCTIVE
TOXICANTS OR FOR EFFECTS ON OR VIA LACTATION THAT TRIGGER CLASSIFICATION OF THE MIXTURE
Cut-off values/concentration limits triggering classification of a mixture as:
Ingredients classified as:
Category 1
reproductive
toxicant
Category 1 reproductive toxicant ......................................................................................
Category 2 reproductive toxicant ......................................................................................
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
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A.8.1 Definitions and General
Considerations
A.8.1.1 Specific target organ toxicity—
single exposure, (STOT–SE) means specific,
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non-lethal target organ toxicity arising from
a single exposure to a chemical. 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
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Category 2
reproductive
toxicant
Additional
category for
effects on or
via lactation
≥0.1%.
≥0.1%.
generalized changes of a less severe nature
involving several organs.
A.8.1.5 Specific target organ toxicity can
occur by any route that is relevant for
humans, i.e., principally oral, dermal or
inhalation.
A.8.1.6 The classification criteria for
specific organ systemic 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.
BILLING CODE 4510–26–P
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A.8.2.1.2 The relevant route(s) of
exposure by which the classified substance
produces damage shall be identified.
A.8.2.1.3 Classification is determined by
expert judgment, on the basis of the weight
of all evidence available including the
guidance presented below.
A.8.2.1.4 Weight of evidence of all 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.
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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
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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 evidence 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;
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(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.
BILLING CODE 4510–26–C
process includes reference to dose/
concentration guidance values as one of the
elements that contribute to the weight of
evidence approach.
A.8.2.1.10.2 When well-substantiated
human data are available showing a specific
target organ toxic effect that can be reliably
attributed to single exposure to a substance,
the substance shall be classified. Positive
human data, regardless of probable dose,
predominates over animal data. Thus, if a
substance is unclassified because specific
target organ toxicity observed was considered
not relevant or significant to humans, if
subsequent human incident data become
available showing a specific target organ
toxic effect, the substance shall be classified.
A.8.2.1.10.3 A substance that has not
been tested for specific target organ toxicity
shall, where appropriate, be classified on the
basis of data from a validated structure
activity relationship and expert judgmentbased 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
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.,
< 2000 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., ≥ 2000 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
(typical of new substances, but also true for
many existing substances), the classification
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Substances of Category 3
A.8.2.2.1
Irritation
Criteria for Respiratory Tract
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 track irritation;
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(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;
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(d) There are currently no 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 toxicity 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, in accordance with the
principles of A.0.2.1 in this Appendix.
TABLE A.8.2—CUT-OFF VALUES/CONCENTRATION LIMITS OF INGREDIENTS OF A MIXTURE CLASSIFIED AS A SPECIFIC
TARGET ORGAN TOXICANT THAT WOULD TRIGGER CLASSIFICATION OF THE MIXTURE AS CATEGORY 1 OR 2
Cut-off values/concentration limits
triggering classification of a mixture as:
Ingredient classified as:
Category 1
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Category 1 Target organ toxicant ............................................................................................................
Category 2 Target organ toxicant ............................................................................................................
A.8.3.4.2 These cut-off values and
consequent classifications shall be applied
equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.8.3.4.3 Mixtures shall be classified for
either or both single and repeated dose
toxicity independently.
A.8.3.4.4 Care shall be exercised when
toxicants affecting more than one organ
system are combined that the potentiation or
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. See A.0.2.1.
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.
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Respiratory tract irritation and narcotic
effects are to be evaluated separately in
accordance with the criteria given in A.8.2.2.
When conducting classifications for these
hazards, the contribution of each ingredient
should be considered additive, unless there
is evidence that the effects are not additive.
A.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) means specific
target organ toxicity arising from 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
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Category 2
≥ 1.0%
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, i.e., 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,
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severity of the effect(s) observed, in
accordance with Figure A.9.1.
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/incidence is usually restricted to
reports of adverse health consequences, often
with uncertainty about exposure conditions,
and may not provide the scientific detail that
can be obtained from well-conducted studies
in experimental animals.
A.9.2.7.3 Evidence from appropriate
studies in experimental animals can furnish
much more detail, in the form of clinical
observations, hematology, clinical chemistry,
macroscopic and microscopic pathological
examination and this can often reveal
hazards that may not be life-threatening but
could indicate functional impairment.
Consequently all available evidence, and
relevance to human health, must be taken
into consideration in the classification
process. Relevant toxic effects in humans
and/or animals include, but are not limited
to:
(a) Morbidity or death resulting from
repeated or long-term exposure. Morbidity or
death may result from repeated exposure,
even to relatively low doses/concentrations,
due to bioaccumulation of the substance or
its metabolites, or due to the overwhelming
of the de-toxification process by repeated
exposure;
(b) Significant functional changes in the
central or peripheral nervous systems or
other organ systems, including signs of
central nervous system depression and
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 incidence, epidemiology,
and studies conducted in experimental
animals, is used to substantiate specific target
organ toxic effects that merit classification.
A.9.2.5 The information required to
evaluate specific target organ toxicity comes
either from repeated exposure in humans,
e.g., exposure at home, in the workplace or
environmentally, or from studies conducted
in experimental animals. The standard
animal studies in rats or mice that provide
this information are 28 day, 90 day or
lifetime studies (up to 2 years) that include
hematological, clinico-chemical and detailed
macroscopic and microscopic examination to
enable the toxic effects on target tissues/
organs to be identified. Data from repeat dose
studies performed in other species may also
be used. Other long-term exposure studies,
e.g., for carcinogenicity, neurotoxicity or
reproductive toxicity, may also provide
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which produced the effect(s), (see A.9.2.9).
Substances shall be placed in one of two
categories, depending upon the nature and
BILLING CODE 4510–26–C
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including the use of recommended guidance
values which take into account the duration
of exposure and the dose/concentration
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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 that is for humans.
A.9.2.9.3 Thus, in animal studies, when
significant toxic effects are observed that
indicate classification, consideration of the
duration of experimental exposure and the
dose/concentration at which these effects
were seen, in relation to the suggested
guidance values, provides useful information
to help assess the need to classify (since the
toxic effects are a consequence of the
hazardous property(ies) and also the duration
of exposure and the dose/concentration).
A.9.2.9.4 The decision to classify at all
can be influenced by reference to the dose/
concentration guidance values at or below
which a significant toxic effect has been
observed.
A.9.2.9.5 The guidance values refer to
effects seen in a standard 90-day toxicity
study conducted in rats. They can be used as
a basis to extrapolate equivalent guidance
values for toxicity studies of greater or lesser
duration, using dose/exposure time
extrapolation similar to Haber’s rule for
inhalation, which states essentially that the
effective dose is directly proportional to the
exposure concentration and the duration of
exposure. The assessment should be done on
a case-by-case basis; for example, for a 28-day
study the guidance values below would be
increased by a factor of three.
A.9.2.9.6 Thus for Category 1
classification, significant toxic effects
observed in a 90-day repeated-dose study
conducted in experimental animals and seen
to occur at or below the (suggested) guidance
values (C) as indicated in Table A.9.1 would
justify classification:
TABLE A.9.1—GUIDANCE VALUES TO ASSIST IN CATEGORY 1 CLASSIFICATION
[Applicable to a 90-day study]
Guidance values
(dose/
concentration)
Route of exposure
Units
Oral (rat) ..............................................................................................................
Dermal (rat or rabbit) ...........................................................................................
Inhalation (rat) gas ...............................................................................................
Inhalation (rat) vapor ...........................................................................................
Inhalation (rat) dust/mist/fume .............................................................................
mg/kg body weight/day ...........
mg/kg body weight/day ...........
ppmV/6h/day ...........................
mg/liter/6h/day .........................
mg/liter/6h/day .........................
A.9.2.9.7 For Category 2 classification,
significant toxic effects observed in a 90-day
repeated-dose study conducted in
experimental animals and seen to occur
within the (suggested) guidance value ranges
C
C
C
C
C
≤
≤
≤
≤
≤
10.
20.
50.
0.2.
0.02.
as indicated in Table A.9.2 would justify
classification:
TABLE A.9.2—GUIDANCE VALUES TO ASSIST IN CATEGORY 2 CLASSIFICATION
[Applicable to a 90-day study]
Guidance value range
(dose/
concentration)
srobinson on DSKHWCL6B1PROD with PROPOSALS2
Route of exposure
Units
Oral (rat) ..............................................................................................................
Dermal (rat or rabbit) ...........................................................................................
Inhalation (rat) gas ...............................................................................................
Inhalation (rat) vapor ...........................................................................................
Inhalation (rat) dust/mist/fume .............................................................................
mg/kg body weight/day ...........
mg/kg body weight/day ...........
ppmV/6h/day ...........................
mg/liter/6h/day .........................
mg/liter/6h/day .........................
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10 < C ≤ 100.
20 < C ≤ 200.
50 < C ≤ 250.
0.2 < C ≤ 1.0.
0.02 < C ≤ 0.2.
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A.9.2.9.8 The guidance values and ranges
mentioned in A.2.9.9.6 and A.2.9.9.7 are
intended only for guidance purposes, i.e., to
be used as part of the weight of evidence
approach, and to assist with decisions about
classification. They are not intended as strict
demarcation values.
A.9.2.9.9 Thus, it is feasible that a
specific profile of toxicity occurs in repeatdose animal studies at a dose/concentration
below the guidance value, e.g., < 100 mg/kg
body weight/day by the oral route; however
the nature of the effect, e.g., nephrotoxicity
seen only in male rats of a particular strain
known to be susceptible to this effect, may
result in the decision not to classify.
Conversely, a specific profile of toxicity may
be seen in animal studies occurring at or
above a guidance value, e.g., ≥ 100 mg/kg
body weight/day by the oral route, and in
addition there is supplementary information
from other sources, e.g., other long-term
administration studies, or human case
experience, which supports a conclusion
that, in view of the weight of evidence,
classification is prudent.
A.9.2.10 Other Considerations
A.9.2.10.1 When a substance is
characterized only by use of animal data
(typical of new substances, but also true for
many existing substances), 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 incidence 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
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
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.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 toxicity 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
in accordance with A.0.2.1.
TABLE A.9.3—CUTOFF 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 as:
Ingredient classified as:
Category 1
srobinson on DSKHWCL6B1PROD with PROPOSALS2
Category 1: Target organ toxicant ...........................................................................................................
Category 2: Target organ toxicant ...........................................................................................................
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. See
A.0.2.1.
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A.10
ASPIRATION HAZARD
A.10.1 Definitions and General and
Specific Considerations
A.10.1.1 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.10.1.2 Aspiration toxicity includes
severe acute effects such as chemical
pneumonia, varying degrees of pulmonary
injury or death following aspiration.
A.10.1.3 Aspiration is initiated at the
moment of inspiration, in the time required
to take one breath, as the causative material
lodges at the crossroad of the upper
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≥ 1.0%.
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Category 2
≥ 1.0%.
respiratory and digestive tracts in the
laryngopharyngeal region.
A.10.1.4 Aspiration of a substance or
mixture can occur as it is vomited following
ingestion. This may have consequences for
labeling, particularly where, due to acute
toxicity, a recommendation may be
considered to induce vomiting after
ingestion. However, if the substance/mixture
also presents an aspiration toxicity hazard,
the recommendation to induce vomiting may
need to be modified.
A.10.1.5 Specific Considerations
A.10.1.5.1 The classification criteria refer
to kinematic viscosity. The following
provides the conversion between dynamic
and kinematic viscosity:
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Dynamic viscosity (mPa ⋅ s)
= Kinematic viscosity mm 2 /s
Density g/cm3
(
A.10.1.5.2 Although the definition of
aspiration in A.10.1.1 includes the entry of
solids into the respiratory system,
classification according to (b) in table A.10.1
for Category 1 is intended to apply to liquid
substances and mixtures only.
A.10.1.5.3 Classification of Aerosol/Mist
Products
Aerosol and mist products are usually
dispensed in containers such as self-
(
)
pressurized containers, trigger and pump
sprayers. Classification for these products
shall be considered if their use may form a
pool of product in the mouth, which then
may be aspirated. If the mist or aerosol from
a pressurized container is fine, a pool may
not be formed. On the other hand, if a
pressurized container dispenses product in a
stream, a pool may be formed that may then
be aspirated. Usually, the mist produced by
)
trigger and pump sprayers is coarse and
therefore, a pool may be formed that then
may be aspirated. When the pump
mechanism may be removed and contents are
available to be swallowed then the
classification of the products should be
considered.
A.10.2 Classification Criteria for
Substances
TABLE A.10.1—CRITERIA FOR ASPIRATION TOXICITY
Category
Criteria
Category 1: Chemicals known to cause human aspiration
toxicity hazards or to be regarded as if they cause
human aspiration toxicity hazard.
A substance shall be classified in Category 1:
(a) If reliable and good quality human evidence indicates that it causes aspiration toxicity (See note 1); or
(b) If it is a hydrocarbon and has a kinematic viscosity ≤ 20.5 mm2/s, measured
at 40 °C.
A.10.3
Classification Criteria for Mixtures
A.10.3.1 Classification When Data Are
Available for the Complete Mixture
B.1
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 toxicity category; and
Substantially similar mixtures. For
application of the dilution bridging principle,
the concentration of aspiration toxicants
shall not be less than 10%.
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A.10.3.3 Classification of Mixtures When
Data Are Available for All Ingredients or
Only for Some Ingredients of the Mixture
A.10.3.3.1 A mixture which contains ≥
10% of an ingredient or ingredients classified
in Category 1, and has a kinematic viscosity
≤ 20.5 mm 2/s, measured at 40 °C, shall be
classified in Category 1.
A.10.3.3.2 In the case of a mixture which
separates into two or more distinct layers,
one of which contains ≥ 10% of an ingredient
or ingredients classified in Category 1 and
has a kinematic viscosity ≤ 20.5 mm 2/s,
measured at 40 °C, then the entire mixture
shall be classified in Category 1.
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Appendix B to § 1910.1200—Physical
Hazard Criteria (Mandatory)
EXPLOSIVES
B.1.1 Definitions and General
Considerations
B.1.1.1 An explosive chemical is a solid
or liquid chemical which is in itself capable
by chemical reaction of producing gas at such
a temperature and pressure and at such a
speed as to cause damage to the
surroundings. Pyrotechnic chemicals are
included even when they do not evolve
gases.
A pyrotechnic chemical is a chemical
designed to produce an effect by heat, light,
sound, gas or smoke or a combination of
these as the result of non-detonative selfsustaining exothermic chemical reactions.
An explosive item is an item containing
one or more explosive chemicals.
A pyrotechnic item is an item containing
one or more pyrotechnic chemicals.
An unstable explosive is an explosive
which is thermally unstable and/or too
sensitive for normal handling, transport, or
use.
An intentional explosive is a chemical or
item which is manufactured with a view to
produce a practical explosive or pyrotechnic
effect.
B.1.1.2 The class of explosives comprises:
(a) Explosive chemicals;
(b) Explosive items, except devices
containing explosive chemicals in such
quantity or of such a character that their
inadvertent or accidental ignition or
initiation shall not cause any effect external
to the device either by projection, fire,
smoke, heat or loud noise; and
(c) Chemicals and items not included
under (a) and (b) above which are
manufactured with the view to producing a
practical explosive or pyrotechnic effect.
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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 contain only extremely
insensitive detonating chemicals and which
demonstrate a negligible probability of
accidental initiation or propagation.
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Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Proposed Rules
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 Recommendations on the
Transport of Dangerous Goods, Manual of
Tests and Criteria, Fourth Revised Edition.
The first step is to ascertain whether the
substance or mixture has explosive effects
(Test Series 1). The second step is the
acceptance procedure (Test Series 2 to 4) and
the third step is the assignment to a hazard
division (Test Series 5 to 7). The assessment
whether a candidate for ‘‘ammonium nitrate
emulsion or suspension or gel, intermediate
for blasting explosives (ANE)’’ is insensitive
enough for inclusion as an oxidizing liquid
(see B.13) or an oxidizing solid (see B.14) is
determined by Test Series 8 tests.
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.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.1.3.3 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
Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition) 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
Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition; or
(b) The substance contains chemical
groups associated with explosive properties
which include oxygen and the calculated
oxygen balance is less than ¥200.
50475
The oxygen balance is calculated for the
chemical reaction:
CxHyOz + [x + (y/4)¥(z/2)] O2 → x. CO2 +
(y/2) H2O
using the formula: oxygen balance =
¥1600 [2x +(y/2) ¥z]/molecular weight;
(c) The organic substance or a homogenous
mixture of organic substances contains
chemical groups associated with explosive
properties but the exothermic decomposition
energy is less than 500 J/g and the onset of
exothermic decomposition is below 500°C.
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:
less than 15%, by mass, if the oxidizing
substance is assigned to Category 1 or 2;
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°C and a
standard pressure of 101.3 kPa (14.7 psi).
B.2.2 Classification Criteria
A flammable gas shall be classified in one
of the two categories for this class in
accordance with Table B.2.1:
TABLE B.2.1—CRITERIA FOR FLAMMABLE GASES
Category
Criteria
1 ...............................................................
Gases, which at 20°C (68°F) and a standard pressure of 101.3 kPa (14.7 psi):
(a) are ignitable when in a mixture of 13% or less by volume in air; or
(b) have a flammable range with air of at least 12 percentage points regardless of the lower flammable limit.
Gases, other than those of Category 1, which, at 20°C (68°F) and a standard pressure of 101.3 kPa
(14.7 psi), have a flammable range while mixed in air.
2 ...............................................................
Note: Aerosols should not be classified as
flammable gases. See B.3.
B.3
B.2.3 Additional Classification
Considerations
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.
Flammability shall be determined by tests
or by calculation in accordance with methods
adopted by ISO (see ISO 10156:1996 ‘‘Gases
and gas mixtures—Determination of fire
potential and oxidizing ability for the
selection of cylinder valve outlets’’). Where
insufficient data are available to use these
methods, equivalent validated methods may
be used.
FLAMMABLE AEROSOLS
B.3.1
B.3.2
Definition
Classification Criteria
B.3.2.1 Aerosols shall be considered for
classification as flammable if they contain
any component which is classified as
flammable in accordance with this
Appendix, i.e.:
Flammable liquids (see B.6);
Flammable gases (see B.2);
Flammable solids (see B.7).
Note 1: Flammable components do not
include pyrophoric, self-heating or waterreactive chemicals.
Note 2: Flammable aerosols do not fall
additionally within the scope of flammable
gases, flammable liquids, or flammable
solids.
B.3.2.2 A flammable aerosol shall be
classified in one of the two categories for this
class in accordance with Table B.3.1.
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TABLE B.3.1—CRITERIA FOR FLAMMABLE AEROSOLS
Category
Criteria
1 .........................
2 .........................
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Contains ≥ 85% of 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, or
(b) for foam aerosols, in the aerosol foam flammability test.
(i) the flame height is ≥ 20 cm and the flame duration ≥ 2 s; or
(ii) the flame height is ≥ 4 cm and the flame duration ≥ 7 s.
Contains > 1% flammable components, or the heat of combustion is ≥ 20 kJ/g; and
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TABLE B.3.1—CRITERIA FOR FLAMMABLE AEROSOLS—Continued
Category
Criteria
(a) for spray aerosols, in the ignition distance test, ignition occurs at a distance ≥ 15 cm, or in the enclosed space ignition test, the
(i) time equivalent is ≤ 300 s/m 3; or
(ii) deflagration density is ≤ 300 g/m 3.
(b) for foam aerosols, in the aerosol foam flammability test, the flame height is ≥ 4 cm and the flame duration is ≥ 2 s
and it does not meet the criteria for Category 1.
Note: Aerosols not submitted to the
flammability classification procedures in this
Appendix shall be classified as extremely
flammable (Category 1).
B.3.3.1 To classify a flammable 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
(DHc), in kilojoules per gram (kJ/g), is the
product of the theoretical heat of combustion
(DHcomb), and a combustion efficiency,
usually less than 1.0 (a typical combustion
efficiency is 0.95 or 95%).
For a composite aerosol formulation, the
chemical heat of combustion is the
summation of the weighted heats of
ΔHc (product)
n
accordance with sub-sections 31.4, 31.5 and
31.6 of the of the UN Recommendations on
the Transport of Dangerous Goods, Manual
of Tests and Criteria, Fourth Revised Edition.
i
B.3.3 Additional Classification
Considerations
combustion for the individual components,
as follows:
B.4
= ∑ [wi% × ΔHc(i)]
Where:
DHc = chemical heat of combustion (kJ/g);
wi% = mass fraction of component i in the
product;
DHc(i) = specific heat of combustion (kJ/g) of
component i in the product;
The chemical heats of combustion shall be
found in literature, calculated or determined
by tests (see ASTM D240–02(2007)—
Standard Test Methods for Heat of
Combustion of Liquid Hydrocarbon Fuels by
Bomb Calorimeter, ISO/FDIS 13943:1999,
86.1 to 86.3—Fire safety—Vocabulary, and
NFPA 30B—Code for the Manufacture and
Storage of Aerosol Products, 2007 Edition).
B.3.3.3 The Ignition distance test,
Enclosed space ignition test and Aerosol
foam flammability test shall be performed in
OXIDIZING GASES
B.4.1
Definition
Oxidizing gas means any gas which may,
generally by providing oxygen, cause or
contribute to the combustion of other
material more than air does.
Note: ‘‘Gases which cause or contribute to
the combustion of other material more than
air does’’ means pure gases or gas mixtures
with an oxidizing power greater than 23.5%
(as determined, by a method specified in ISO
10156:1996 or 10156–2:2005 or an equivalent
testing method.)
B.4.2
Classification Criteria
An oxidizing gas shall be classified in a
single category for this class in accordance
with Table B.4.1:
TABLE B.4.1—CRITERIA FOR OXIDIZING GASES
Category
Criteria
1 .........................
Any gas which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air
does.
B.4.3 Additional Classification
Considerations
Classification shall be in accordance with
tests or calculation methods as described in
ISO 10156:1996 ‘‘Gases and gas mixtures—
Determination of fire potential and oxidizing
ability for the selection of cylinder valve
outlet’’ and ISO 10156–2:2005 ‘‘Gas
cylinders, Gases and gas mixtures. Part 2:
Determination of oxidizing ability of toxic
and corrosive gases and gas mixtures’’.
B.5
GASES UNDER PRESSURE
B.5.1
Definition
liquefied or liquefied and refrigerated. They
comprise compressed gases, liquefied gases,
dissolved gases and refrigerated liquefied
gases.
B.5.2
Gases under pressure are gases which are
contained in a receptacle at a pressure of 200
kPa (29 psi) (gauge) or more, or which are
Classification Criteria
Gases under pressure shall be classified in
one of four groups in accordance with Table
B.5.1:
TABLE B.5.1—CRITERIA FOR GASES UNDER PRESSURE
Group
Criteria
Compressed gas .............................
A gas which when under pressure is entirely gaseous at –50 °C (¥58 °F); including all gases with a critical temperature 1 ≤ ¥50 °C (¥58 °F).
A gas which when under pressure is partially liquid at temperatures above ¥50 °C (¥58 °F). A distinction
is made between:
(a) High pressure liquefied gas: a gas with a critical temperature1 between ¥50 °C (¥58 °F) and +65
°C (149 °F); and
(b) Low pressure liquefied gas: a gas with a critical temperature 1 above +65 °C (149 °F).
A gas which is made partially liquid because of its low temperature.
A gas which when under pressure is dissolved in a liquid phase solvent.
Refrigerated liquefied gas ...............
Dissolved gas ..................................
(1) The critical temperature is the temperature above which a pure gas cannot be liquefied, regardless of the degree of compression.
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Liquefied gas ...................................
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Proposed Rules
B.6
FLAMMABLE LIQUIDS
B.6.2
B.6.1 Definition
Flammable liquid means a liquid having a
flash point of not more than 93 °C (199.4 °F).
50477
Classification Criteria
A flammable liquid shall be classified in
one of four categories in accordance with
Table B.6.1:
TABLE B.6.1—CRITERIA FOR FLAMMABLE LIQUIDS
Category
1
2
3
4
Criteria
......................................................
......................................................
......................................................
......................................................
Flash
Flash
Flash
Flash
point
point
point
point
B.6.3 Additional Classification
Considerations
The flash point shall be determined in
accordance with Standard Method of Test for
Flash Point by Tag Closed Tester (ASTM D
56–93), Standard Methods of Test for Flash
Point of Liquids by Setaflash Closed Tester
(ASTM D 3278–96), Standard Methods of
Test for Flash Point by Small Scale Closed
Tester (ASTM D 3828–93), Standard Method
of Test for Flash Point by Pensky-Martens
Closed Tester (ASTM D 0093–96), or any
other method specified in GHS Revision 3,
Chapter 2.6.
The initial boiling point shall be
determined in accordance with ‘‘Standard
Test Method for Distillation of Petroleum
Products at Atmospheric Pressure (ASTM
D86–07a) or Standard Test Method for
Distillation Range of Volatile Organic Liquids
(ASTM D1078–05).
<23 °C (73.4 °F) and initial boiling point ≤ 35 °C (95 °F).
<23 °C (73.4 °F) and initial boiling point > 35 °C (95 °F).
≥ 23 °C (73.4 °F) and ≤ 60 °C (140 °F).
> 60 °C (140 °F) and ≤ 93 °C (199.4 °F).
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 Recommendations on the Transport
of Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition, Part III, subsection 33.2.1, is less than 45 s or the rate of
burning is more than 2.2 mm/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
Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition, in
accordance with Table B.7.1:
TABLE B.7.1—CRITERIA FOR FLAMMABLE SOLIDS
Category
Criteria
1 ......................................................
2 ......................................................
Burning rate test:
Chemicals other than metal powders:
(a) wetted zone does not stop fire; and
(b) burning time < 45 s or burning rate > 2.2 mm/s.
Metal powders: burning time ≤ 5 min.
Burning rate test:
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.
srobinson on DSKHWCL6B1PROD with PROPOSALS2
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.8
B.8.1
SELF-REACTIVE CHEMICALS
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
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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
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according to the procedure defined in
B.8.2.2;
(c) It is classified as an organic peroxide
according to B.15 of this appendix;
(d) Its heat of decomposition is less than
300 J/g; or
(e) Its self-accelerating decomposition
temperature (SADT) is greater than 75 °C
(167 °F) for a 50 kg 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.
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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:
(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;
will be defined as self-reactive chemical
TYPE D;
(e) Any self-reactive chemical which, in
laboratory testing, neither detonates nor
deflagrates at all and shows low or no effect
when heated under confinement will be
defined as self-reactive chemical TYPE E;
(f) Any self-reactive chemical which, in
laboratory testing, neither detonates in the
cavitated state nor deflagrates at all and
shows only a low or no effect when heated
under confinement as well as low or no
explosive power will be defined as selfreactive chemical TYPE F;
(g) Any self-reactive chemical which, in
laboratory testing, neither detonates in the
cavitated state nor deflagrates at all and
shows no effect when heated under
confinement nor any explosive power,
provided that it is thermally stable (selfaccelerating decomposition temperature is 60
°C (140 °F) to 75 °C (167 °F) for a 50 kg
package), and, for liquid mixtures, a diluent
having a boiling point greater than or equal
to 150 °C (302 °F) is used for desensitization
will be defined as self-reactive chemical
TYPE G. If the mixture is not thermally stable
or a diluent having a boiling point less than
150°C (302°F) is used for desensitization, the
mixture shall be defined as self-reactive
chemical TYPE F.
B.8.3 Additional Classification
Considerations
B.8.3.3 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 Recommendations
on the Transport of Dangerous Goods,
Manual of Tests and Criteria, Fourth Revised
Edition; or
(b) For a single organic substance or a
homogeneous mixture of organic substances,
the estimated SADT is greater than 75°C
(167°F) or the exothermic decomposition
energy is less than 300 J/g. The onset
temperature and decomposition energy may
be estimated using a suitable calorimetric
technique (see 20.3.3.3 in Part II of the UN
Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition).
B.9.1
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
Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition.
B.8.3.2 Self-accelerating decomposition
temperature (SADT) shall be determined in
accordance with the UN Recommendations
for the Transport of Dangerous Goods,
Manual of Tests and Criteria, Fourth Revised
Edition, Part II, section 28.
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
Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition, 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.
B.9.3 Additional Classification
Considerations
be stable at room temperature for prolonged
periods of time (days)).
The classification procedure for pyrophoric
liquids need not be applied when experience
in production or handling shows that the
chemical does not ignite spontaneously on
coming into contact with air at normal
temperatures (i.e. the substance is known to
B.10
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
Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition in
accordance with Table B.10.1:
TABLE B.10.1—CRITERIA FOR PYROPHORIC SOLIDS
Category
Criteria
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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.
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B.10.3 Additional Classification
Considerations
be stable at room temperature for prolonged
periods of time (days)).
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
B.11
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B.11.1
SELF-HEATING CHEMICALS
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;
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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
50479
class if, in tests performed in accordance
with test method N.4 in Part III, sub-section
33.3.1.6 of the UN Recommendations on the
Transport of Dangerous Goods, Manual of
Tests and Criteria, Fourth Revised Edition,
the result meets the criteria shown in Table
B.11.1.
TABLE B.11.1—CRITERIA FOR SELF-HEATING CHEMICALS
Category
Criteria
1 ......................................................
2 ......................................................
A positive result is obtained in a test using a 25 mm sample cube at 140 °C (284 °F).
A negative result is obtained in a test using a 25 mm cube sample at 140 °C (284 °F), a positive result is
obtained in a test using a 100 mm sample cube at 140 °C (284 °F), and:
(a) the unit volume of the chemical is more than 3 m3; or
(b) a positive result is obtained in a test using a 100 mm cube sample at 120 °C (248 °F) and the unit
volume of the chemical is more than 450 liters; or
(c) a positive result is obtained in a test using a 100 mm cube sample at 100 °C (212 °F).
B.11.2.2 Chemicals with a temperature of
spontaneous combustion higher than 50 °C
(122 °F) for a volume of 27 m3 shall not be
classified as self-heating chemicals.
B.11.2.3 Chemicals with a spontaneous
ignition temperature higher than 50 °C (122
°F) for a volume of 450 liters shall not be
classified in Category 1 of this class.
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°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°K above the reference temperature for a
volume of 1 l.
B.12 CHEMICALS WHICH, IN CONTACT
WITH WATER, EMIT FLAMMABLE GASES
chemicals which, by interaction with water,
are liable to become spontaneously
flammable or to give off flammable gases in
dangerous quantities.
B.12.2
Classification Criteria
B.12.2.1 A chemical which, in contact
with water, emits flammable gases shall be
classified in one of the three categories for
this class, using test N.5 in Part III, subsection 33.4.1.4 of the UN Recommendations
on the Transport of Dangerous Goods,
Manual of Tests and Criteria, Fourth Revised
Edition, in accordance with Table B.12.1:
B.12.1 Definition
Chemicals which, in contact with water,
emit flammable gases are solid or liquid
TABLE B.12.1—CRITERIA FOR CHEMICALS WHICH, IN CONTACT WITH WATER, EMIT FLAMMABLE GASES
Category
Criteria
1 ......................................................
Any chemical which reacts vigorously with water at ambient temperatures and demonstrates generally a
tendency for the gas produced to ignite spontaneously, or which reacts readily with water at ambient
temperatures such that the rate of evolution of flammable gas is equal to or greater than 10 liters per
kilogram of chemical over any one minute.
Any chemical which reacts readily with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 20 liters per kilogram of chemical per hour, and which
does not meet the criteria for Category 1.
Any chemical which reacts slowly with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 1 liter per kilogram of chemical per hour, and which
does not meet the criteria for Categories 1 and 2.
2 ......................................................
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3 ......................................................
Note: Classification of solid chemicals
shall be based on tests performed on the
chemical as presented. If, for example, for the
purposes of supply or transport, the same
chemical is to be presented in a physical
form different from that which was tested
and which is considered likely to materially
alter its performance in a classification test,
classification must be based on testing of the
chemical in the new form.
B.12.2.2 A chemical is classified as a
chemical which, in contact with water, emits
flammable gases if spontaneous ignition takes
place in any step of the test procedure.
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B.12.3 Additional Classification
Considerations
B.13
The classification procedure for this class
need not be applied if:
(a) The chemical structure of the chemical
does not contain metals or metalloids;
(b) Experience in production or handling
shows that the chemical does not react with
water, (e.g., the chemical is manufactured
with water or washed with water); or
(c) The chemical is known to be soluble in
water to form a stable mixture.
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B.13.1
OXIDIZING LIQUIDS
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 Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
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Criteria, Fourth Revised Edition, in
accordance with Table B.13.1:
TABLE B.13.1—CRITERIA FOR OXIDIZING LIQUIDS
Category
Criteria
1 ......................................................
Any chemical which, in the 1:1 mixture, by mass, of chemical and cellulose tested, spontaneously ignites;
or the mean pressure rise time of a 1:1 mixture, by mass, of chemical and cellulose is less than that of a
1:1 mixture, by mass, of 50% perchloric acid and cellulose;
Any chemical which, in the 1:1 mixture, by mass, of chemical and cellulose tested, exhibits a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 40% aqueous sodium chlorate solution and cellulose; and the criteria for Category 1 are not met;
Any chemical which, in the 1:1 mixture, by mass, of chemical and cellulose tested, exhibits a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 65% aqueous nitric acid and cellulose; and the criteria for Categories 1 and 2 are not met.
2 ......................................................
3 ......................................................
B.13.3 Additional Classification
Considerations
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 tests 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.13.3.4 In cases where chemicals
generate a pressure rise (too high or too low),
caused by chemical reactions not
characterizing the oxidizing properties of the
chemical, the test described in Part III, subsection 34.4.2 of the UN Recommendations
on the Transport of Dangerous Goods,
Manual of Tests and Criteria, Fourth Revised
Edition 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
B.14.1
OXIDIZING SOLIDS
Definition
Oxidizing solid means a solid which, while
in itself is not necessarily combustible, may,
generally by yielding oxygen, cause, or
contribute to, the combustion of other
material.
B.14.2
Classification Criteria
An oxidizing solid shall be classified in
one of the three categories for this class using
test O.1 in Part III, sub-section 34.4.1 of the
UN Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition, in
accordance with Table B.14.1:
TABLE B.14.1—CRITERIA FOR OXIDIZING SOLIDS
Category
Criteria
1 .........................
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time less than the
mean burning time of a 3:2 mixture, by mass, of potassium bromate and cellulose.
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or
less than the mean burning time of a 2:3 mixture (by mass) of potassium bromate and cellulose and the criteria for Category 1 are not met.
Any chemical which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or
less than the mean burning time of a 3:7 mixture (by mass) of potassium bromate and cellulose and the criteria for Categories 1 and 2 are not met.
2 .........................
3 .........................
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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’’ (IMO: Code of Safe Practice
for Solid Bulk Cargoes, 2005, Annex 3, Test
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.
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B.14.3 Additional Classification
Considerations
B.15
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 tests results and known experience
in the handling and use of chemicals which
shows them to be oxidizing, judgements
based on known experience shall take
precedence over test results.
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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
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violent effect when heated under
confinement.
B.15.2
Classification Criteria
B.15.2.1 Any organic peroxide shall be
considered for classification in this class,
unless it contains:
(a) Not more than 1.0% available oxygen
from the organic peroxides when containing
not more than 1.0% hydrogen peroxide; or
(b) Not more than 0.5% available oxygen
from the organic peroxides when containing
more than 1.0% but not more than 7.0%
hydrogen peroxide.
Note: The available oxygen content (%) of
an organic peroxide mixture is given by the
formula:
Where:
ni = number of peroxygen groups per
molecule of organic peroxide i;
ci = concentration (mass %) of organic
peroxide i;
mi = molecular mass of organic peroxide i.
B.15.2.2 Organic peroxides shall be
classified in one of the seven categories of
‘‘Types A to G’’ for this class, according to
the following principles:
(a) Any organic peroxide which, as
packaged, can detonate or deflagrate rapidly
shall be defined as organic peroxide TYPE A;
(b) Any organic peroxide possessing
explosive properties and which, as packaged,
neither detonates nor deflagrates rapidly, but
is liable to undergo a thermal explosion in
that package shall be defined as organic
peroxide TYPE B;
(c) Any organic peroxide possessing
explosive properties when the chemical as
packaged cannot detonate or deflagrate
rapidly or undergo a thermal explosion shall
be defined as organic peroxide TYPE C;
(d) Any organic peroxide which in
laboratory testing:
(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; shall be defined as
organic peroxide TYPE D;
(e) Any organic peroxide which, in
laboratory testing, neither detonates nor
deflagrates at all and shows low or no effect
when heated under confinement shall be
defined as organic peroxide TYPE E;
(f) Any organic peroxide which, in
laboratory testing, neither detonates in the
cavitated state nor deflagrates at all and
shows only a low or no effect when heated
under confinement as well as low or no
explosive power shall be defined as organic
peroxide TYPE F;
(g) Any organic peroxide which, in
laboratory testing, neither detonates in the
cavitated state nor deflagrates at all and
shows no effect when heated under
confinement nor any explosive power,
provided that it is thermally stable (selfaccelerating decomposition temperature is 60
°C (140 °F) or higher for a 50 kg package),
and, for liquid mixtures, a diluent having a
boiling point of not less than 150 °C (302 °F)
is used for desensitization, shall be defined
as organic peroxide TYPE G. If the organic
peroxide is not thermally stable or a diluent
having a boiling point less than 150 °C (302
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°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
Recommendations on the Transport of
Dangerous Goods, Manual of Tests and
Criteria, Fourth Revised Edition.
B.15.3.2 Self-accelerating decomposition
temperature (SADT) shall be determined in
accordance with the UN Recommendations
for the Transport of Dangerous Goods,
Manual of Tests and Criteria, Fourth Revised
Edition, Part II, section 28.
B.15.3.3 Mixtures of organic peroxides
may be classified as the same type of organic
peroxide as that of the most dangerous
ingredient. However, as two stable
ingredients can form a thermally less stable
mixture, the SADT of the mixture shall be
determined.
B.16
B.16.1
CORROSIVE TO METALS
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 Recommendations on the
Transport of Dangerous Goods, Manual of
Tests and Criteria, Fourth Revised Edition, in
accordance with Table B.16.1:
TABLE B.16.1—CRITERIA FOR CHEMICALS CORROSIVE TO METAL
Category
Criteria
1 ......................................................
Corrosion rate on either steel or aluminium surfaces exceeding 6.25 mm per year at a test temperature of
55 °C (131 °F) when tested on both materials.
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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.
Appendix C to § 1910.1200– Allocation
of Label Elements (Mandatory)
C.1 The label for each hazardous
chemical shall include the product identifier
used on the safety data sheet
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C.1.1 The labels on shipped containers
shall also include the name, address, and
telephone number of the 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. For
unclassified hazards, the label shall include
a description of the hazards and appropriate
precautions for safe handling and use under
supplementary information.
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;
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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.
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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.
C.2.3
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Pictograms
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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
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with a red frame sufficiently wide to be
clearly visible.
C.2.3.2 One of eight standard hazard
symbols shall be used in each pictogram. The
eight hazard symbols are depicted in Figure
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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 Where a label required by the
Department of Transportation under Title 49
of the Code of Federal Regulations appears
on a container, the pictogram specified in C.4
for the same hazard shall not appear.
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C.2.4 Precautionary Statement Text
C.2.4.1 There are four types of
precautionary statements presented,
‘‘prevention,’’ ‘‘response,’’ ‘‘storage,’’ and
‘‘disposal.’’ The core part of the
precautionary statement is presented in bold
print. This is the text, except as otherwise
specified, that shall appear on the label.
Where additional information is required, it
is indicated in plain text.
C.2.4.2 When a backslash or diagonal
mark [/] appears in the precautionary
statement text, it indicates that a choice has
to be made between the separated phrases. In
such cases, the 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
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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 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.2.4.6 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). An order of precedence may be
imposed by the manufacturer, importer or
responsible party in situations where phrases
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concern ‘‘Response.’’ Rapid action may be
crucial. For example, if a chemical is
carcinogenic and acutely toxic, rapid action
may be crucial, and first aid measures for
acute toxicity will take precedence over those
for long term effects. In addition, medical
attention to delayed health effects may be
required in cases of incidental exposure,
even if not associated with immediate
symptoms of intoxication.
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, or when it provides
information about unclassified hazards.
C.3.2 Where the 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%, a statement that ×
percent of the mixture consists of
ingredient(s) of unknown toxicity is required
on the label.
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BILLING CODE 4510–26–C
Table D.1 under the section number and
heading indicated for sections 1–11 and
16. If no relevant information is found
for any given subheading, the SDS shall
clearly indicate that no applicable
Appendix D to § 1910.1200—Safety
Data Sheets (Mandatory)
A safety data sheet (SDS) shall
include the information specified in
information is available. Sections 12–15
may be included in the SDS, but are not
mandatory.
TABLE D.1—MINIMUM INFORMATION FOR AN SDS
1. Identification ....................................................
2. Hazard(s) identification ...................................
3. Composition/information on ingredients .........
4. First-aid measures ..........................................
5. Fire-fighting measures ....................................
6. Accidental release measures .........................
7. Handling and storage .....................................
8. Exposure controls/personal protection ...........
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9. Physical and chemical properties ...................
10. Stability and reactivity ...................................
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(a) Product identifier used on the label;
(b) Other means of identification;
(c) Recommended use of the chemical and restrictions on use;
(d) Name, address, and telephone number of the manufacturer, importer, or other responsible
party;
(e) Emergency phone number.
(a) Classification of the chemical in accordance with paragraph (d) of this section;
(b) Signal word, hazard statement(s), symbol(s) and precautionary statement(s) in accordance
with paragraph (f) of this section. (Hazard symbols may be provided as graphical reproductions or the name of the symbol, e.g., flame, skull and crossbones);
(c) Unclassified hazards (e.g., combustible dust or dust explosion hazard);
(d) Where an ingredient with unknown acute toxicity is used in a mixture at a concentration ≥
1%, a statement that × percent of the mixture consists of ingredient(s) of unknown toxicity is
required.
Except as provided for in paragraph (i) of this section 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 which are themselves classified and which contribute to
the classification of the substance.
For Mixtures
The chemical name and concentration or concentration ranges of all ingredients which are
classified as health hazards in accordance with paragraph (d) of this section.
For All Chemicals Where a Trade Secret is Claimed
Where a trade secret is claimed in accordance with paragraph (i) of this section, a statement
that the specific chemical identity and/or percentage of composition has been withheld as a
trade secret is required.
(a) Description of necessary measures, subdivided according to the different routes of exposure, i.e., inhalation, skin and eye contact, and ingestion;
(b) Most important symptoms/effects, acute and delayed.
(c) Indication of immediate medical attention and special treatment needed, if necessary.
(a) Suitable (and unsuitable) extinguishing media.
(b) Specific hazards arising from the chemical (e.g., nature of any hazardous combustion products).
(c) Special protective equipment and precautions for fire-fighters.
(a) Personal precautions, protective equipment, and emergency procedures.
(b) Methods and materials for containment and cleaning up.
(a) Precautions for safe handling.
(b) Conditions for safe storage, including any incompatibilities.
(a) OSHA permissible exposure limit (PEL) and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the safety data
sheet.
(b) Appropriate engineering controls.
(c) Individual protection measures, such as personal protective equipment.
(a) Appearance (physical state, color, etc.);
(b) Odor;
(c) Odor threshold;
(d) pH;
(e) Melting point/freezing point;
(f) Initial boiling point and boiling range;
(g) Flash point;
(h) Evaporation rate;
(i) Flammability (solid, gas);
(j) Upper/lower flammability or explosive limits;
(k) Vapor pressure;
(l) Vapor density;
(m) Relative density;
(n) Solubility(ies);
(o) Partition coefficient: n-octanol/water;
(p) Auto-ignition temperature;
(q) Decomposition temperature;
(r) Viscosity.
(a) Reactivity;
(b) Chemical stability;
(c) Possibility of hazardous reactions;
(d) Conditions to avoid (e.g., static discharge, shock, or vibration);
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TABLE D.1—MINIMUM INFORMATION FOR AN SDS—Continued
11. Toxicological information ..............................
(e) Incompatible materials;
(f) Hazardous decomposition products.
Description of the various toxicological (health) effects and the available data used to identify
those effects, including:
(a) information on the likely routes of exposure (inhalation, ingestion, skin and eye contact);
(b) Symptoms related to the physical, chemical and toxicological characteristics;
(c) Delayed and immediate effects and also chronic effects from short and long term exposure;
(d) Numerical measures of toxicity (such as acute toxicity estimates).
12. Ecological information (Non-mandatory).
13. Disposal considerations (Non-mandatory) ...
14. Transport information (Non-mandatory) .......
15. Regulatory information (Non-mandatory) .....
16. Other information, including date of preparation or last revision.
*
*
*
*
*
Appendix F to § 1910.1200– Guidance
for Hazard Classifications Re:
Carcinogenicity (Non-Mandatory)
The mandatory criteria for classification of
a chemical for carcinogenicity are found in
Chapter A.6. However, as noted in Footnote
5 of that chapter, the GHS also included as
guidance for classifiers the following
information taken from the International
Agency for Research on Cancer (IARC)
Monographs programme on the evaluation of
the strength and evidence of carcinogenic
risks to humans. This guidance is consistent
with Chapter A. 6, and should help in
evaluating information to determine
carcinogenicity.
Background Guidance
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Carcinogenicity in Humans
The evidence relevant to carcinogenicity
from studies in humans is classified into one
of the following categories:
(a) Sufficient evidence of carcinogenicity:
A causal relationship has been established
between exposure to the agent, mixture or
exposure circumstance and human cancer.
That is, a positive relationship has been
observed between the exposure and cancer in
studies in which chance, bias and
confounding could be ruled out with
reasonable confidence; or,
(b) Limited evidence of carcinogenicity: A
positive association has been observed
between exposure to the agent, mixture or
exposure circumstance and cancer for which
a causal interpretation is considered by the
working group to be credible, but chance,
bias or confounding could not be ruled out
with reasonable confidence.
In some instances the above categories may
be used to classify the degree of evidence
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(a) Ecotoxicity (aquatic and terrestrial, where available);
(b) Persistence and degradability;
(c) Bioaccumulative potential;
(d) Mobility in soil;
(e) Other adverse effects (such as hazardous to the ozone layer).
Description of waste residues and information on their safe handling and methods of disposal,
including the disposal of any contaminated packaging.
(a) UN number;
(b) UN proper shipping name;
(c) Transport hazard class(es);
(d) Packing group, if applicable;
(e) Environmental hazards (e.g., Marine pollutant (Yes/No));
(f) Transport in bulk (according to Annex II of MARPOL 73/78 and the IBC Code);
(g) Special precautions which a user needs to be aware of, or needs to comply with, in connection with transport or conveyance either within or outside their premises.
Safety, health and environmental regulations specific for the product in question.
The date of preparation of the SDS or the last change to it.
related to carcinogenicity in specific organs
or tissues.
Carcinogenicity in Experimental Animals
The evidence relevant to carcinogenicity in
experimental animals is classified into one of
the following categories:
(a) Sufficient evidence of carcinogenicity:
A causal relationship has been established
between the agent or mixture and an
increased incidence of malignant neoplasms
or of an appropriate combination of benign
and malignant neoplasms in (i) two or more
species of animals or (ii) in two or more
independent studies in one species carried
out at different times or in different
laboratories or under different protocols;
(b) Exceptionally, a single study in one
species might be considered to provide
sufficient evidence of carcinogenicity when
malignant neoplasms occur to an unusual
degree with regard to incidence, site, type of
tumor or age at onset; or,
(c) Limited evidence of carcinogenicity:
The data suggest a carcinogenic effect but are
limited for making a definitive evaluation
because, for example, (i) the evidence of
carcinogenicity is restricted to a single
experiment; or (ii) there are unresolved
questions regarding the adequacy of the
design, conduct or interpretation of the
study; or (iii) the agent or mixture increases
the incidence only of benign neoplasms or
lesions of uncertain neoplastic potential, or
of certain neoplasms which may occur
spontaneously in high incidences in certain
strains.
Guidance on How to Consider Important
Factors in Classification of Carcinogenicity*
This section provides some considerations
and an approach to analysis, rather than
hard-and- fast rules. The weight of evidence
analysis called for in GHS is an integrative
approach which considers important factors
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in determining carcinogenic potential along
with the strength of evidence analysis. The
IPCS ‘‘Conceptual Framework for Evaluating
a Mode of Action for Chemical
carcinogenesis’’ (2001), the International Life
Sciences Institute (ILSI) ‘‘Framework for
Human Relevance Analysis of Information on
Carcinogenic Modes of Action’’ (Meek et al.,
2003; Cohen et al., 2003, 2004) and the IARC
(Preamble section 12(b)) provide a basis for
systematic assessments which may be
performed in a consistent fashion. The IPCS
also convened a panel in 2004 to further
develop and clarify the human relevance
framework. However, the available
documents are not intended to dictate
answers, nor provide lists of criteria to be
checked off.
Mode of Action
Various documents on carcinogen
assessment all note that mode of action in
and of itself, or consideration of comparative
metabolism, should be evaluated on a caseby-case basis and are part of an analytic
evaluative approach. One must look closely
at any mode of action in animal experiments
taking into consideration comparative
toxicokinetics/toxicodynamics between the
animal test species and humans to determine
the relevance of the results to humans. This
may lead to the possibility of discounting
very specific effects of certain types of
substances. Life stage-dependent effects on
cellular differentiation may also lead to
qualitative differences between animals and
humans. Only if a mode of action of tumor
development is conclusively determined not
to be operative in humans may the
carcinogenic evidence for that tumor be
discounted. However, a weight of evidence
evaluation for a substance calls for any other
tumorigenic activity to be evaluated, as well.
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Responses in Multiple Animal Experiments
Positive responses in several species add to
the weight of evidence that a substance is a
carcinogen. Taking into account all of the
factors listed in A.6.2.5.2 and more, such
chemicals with positive outcomes in two or
more species would be provisionally
considered to be classified in GHS Category
1B until human relevance of animal results
are assessed in their entirety. It should be
noted, however, that positive results for one
species in at least two independent studies,
or a single positive study showing unusually
strong evidence of malignancy may also lead
to Category 1B.
Confounding Effects of Excessive Toxicity or
Localized Effects
Tumors occurring only at excessive doses
associated with severe toxicity generally have
doubtful potential for carcinogenicity in
humans. In addition, tumors occurring only
at sites of contact and/or only at excessive
doses need to be carefully evaluated for
human relevance for carcinogenic hazard.
For example, forestomach tumors, following
administration by gavage of an irritating or
corrosive, non-mutagenic chemical, may be
of questionable relevance. However, such
determinations must be evaluated carefully
in justifying the carcinogenic potential for
humans; any occurrence of other tumors at
distant sites must also be considered.
*References:
Cohen, S.M., J. Klaunig, M.E. Meek, R.N. Hill,
T. Pastoor, L. Lehman-McKeeman, J.
Bucher, D.G. Longfellow, J. Seed, V.
Dellarco, P. Fenner-Crisp, and D. Patton.
2004. Evaluating the human relevance of
chemically induced animal tumors.
Toxicol. Sci., 78(2): 181–186.
Cohen, S.M., M.E. Mkke, J.E. Klaunig, D.E.
Patton, P.A. Fenner-Crisp. 2003. The
human relevance of information on
carcinogenic modes of action: overview.
Crit. Rev. Toxicol. 33(6), 581–9.
Meek, M.E., J.R. Bucher, S.M. Cohen, V.
Dellarco, R.N. Hill, L. LehmanMcKeeman, D.G. Longfellow, T. Pastoor,
J. Seed, D.E. Patton. 2003. A framework
for human relevance analysis of
information on carcinogenic modes of
action. Crit. Rev. Toxicol., 33(6), 591–
653.
Sonich-Mullin, C., R. Fielder, J. Wiltse, K.
Baetcke, J. Dempsey, P. Fenner-Crisp, D.
Grant, M. Hartley, A. Knapp, D. Kroese,
I. Mangelsdorf, E. Meek, J.M. Rice, and
M. Younes. 2001. The Conceptual
Framework for Evaluating a Mode of
Action for Chemical Carcinogenesis. Reg.
Tox. Pharm. 34, 146–152.
International Programme on Chemical Safety
Harmonization Group. 2004 Report of
the First Meeting of the Cancer Working
Group. World Health Organization.
Report IPCS/HSC–CWG–1/04, Geneva.
International Agency for Research on Cancer.
IARC Monographs on the Evaluation of
Carcinogenic Risks to Human. Preambles
to volumes. World Health Organization.
Lyon, France.
S.M. Cohen, P.A. Fenner-Crisp, and D.E.
Patton. 2003. Special Issue: Cancer
Modes of Action and Human Relevance.
Critical Reviews in Toxicology, R.O.
McClellan, ed., Volume 33/Issue 6. CRC
Press.
C.C. Capen, E. Dybing and J.D. Wilbourn.
1999. Species differences in Thyroid,
Kidney and Urinary Bladder
Carcinogenesis. International Agency for
Research on Cancer, Scientific
Publication N° 147.
Tumor Type, Reduced Tumor Latency
Unusual tumor types or tumors occurring
with reduced latency may add to the weight
of evidence for the carcinogenic potential of
a substance, even if the tumors are not
statistically significant.
Toxicokinetic behaviour is normally
assumed to be similar in animals and
humans, at least from a qualitative
perspective. On the other hand, certain tumor
types in animals may be associated with
toxicokinetics or toxicodynamics that are
unique to the animal species tested and may
not be predictive of carcinogenicity in
humans. Very few such examples have been
agreed internationally. However, one
example is the lack of human relevance of
kidney tumors in male rats associated with
compounds causing a2u-globulin
nephropathy (IARC, Scientific Publication N°
147). Even when a particular tumor type may
be discounted, expert judgment must be used
in assessing the total tumor profile in any
animal experiment.
32. Amend § 1910.1450 as follows:
A. Remove the definitions of
Combustible Liquid, Compressed gas,
Explosive, Flammable, Flashpoint,
Organic peroxide, Oxidizer, Unstable
(reactive), and Water-reactive from
paragraph (b).
B. Revise the definitions of Hazardous
chemical, Physical hazard, and
Reproductive toxins in paragraph (b);
C. Add definitions of Health hazard
and Mutagen in alphabetical order in
paragraph (b); and
D. Amend paragraphs (f)(3)(v), (h)(1),
(h)(1)(ii) and (h)(2)(iii) by removing the
phrase ‘‘material safety data sheets’’ and
inserting the phrase ‘‘safety data sheets’’
in its place.
The revisions and additions read as
follows:
srobinson on DSKHWCL6B1PROD with PROPOSALS2
Responses Are in One Sex or Both Sexes
Any case of gender-specific tumors should
be evaluated in light of the total tumorigenic
response to the substance observed at other
sites (multi-site responses or incidence above
background) in determining the carcinogenic
potential of the substance.
If tumors are seen only in one sex of an
animal species, the mode of action should be
carefully evaluated to see if the response is
consistent with the postulated mode of
action. Effects seen only in one sex in a test
species may be less convincing than effects
seen in both sexes, unless there is a clear
patho-physiological difference consistent
with the mode of action to explain the single
sex response.
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§ 1910.1450 Occupational exposure to
hazardous chemicals in laboratories.
*
*
*
*
*
(b) * * *
Hazardous chemical means any
chemical that is defined as a hazardous
chemical in accordance with the Hazard
Communication Standard (29 CFR
1910.1200). Appendices A and B of the
Hazard Communication Standard
provide criteria for classification of
health hazards and physical hazards.
Health hazard means a chemical that
is classified as posing one of the
following hazardous effects: acute
toxicity (any route of exposure); skin
corrosion or irritation; serious eye
damage or eye irritation; respiratory or
skin sensitization; germ cell
mutagenicity; carcinogenity;
reproductive toxicity; specific target
organ toxicity (single or repeated
exposure); or aspiration hazard. The
criteria for determining whether a
chemical is classified as a health hazard
are detailed in Appendix A of the
Hazard Communication Standard (29
CFR 1910.1200).
*
*
*
*
*
Mutagen means chemicals that cause
permanent changes in the amount or
structure of the genetic material in a
cell. Chemicals classified as mutagens
in accordance with the Hazard
Communication Standard (29 CFR
1910.1200) shall be considered
mutagens for purposes of this section.
*
*
*
*
*
Physical hazard means a chemical
that is classified as posing one of the
following hazardous effects: explosive;
flammable (gases, aerosols, liquids, or
solids); oxidizer (liquid, solid, or gas);
self reactive; pyrophoric (liquid or
solid); self-heating; organic peroxide;
corrosive to metal; gas under pressure;
or in contact with water emits
flammable gas. The criteria for
determining whether a chemical is
classified as a physical hazard are in
Appendix B of the Hazard
Communication Standard (29 CFR
1910.1200).
*
*
*
*
*
Reproductive toxins means chemicals
that affect the reproductive capabilities
including adverse effects on sexual
function and fertility in adult males and
females, as well as adverse effects on the
development of the offspring. Chemicals
classified as reproductive toxins in
accordance with the Hazard
Communication Standard (29 CFR
1910.1200) shall be considered
reproductive toxins for purposes of this
section.
*
*
*
*
*
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Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Proposed Rules
PART 1915—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS FOR
SHIPYARD EMPLOYMENT
33. Revise the authority citation for
part 1915 to read as follows:
Authority: Section 41, Longshore and
Harbor Workers’ Compensation Act (33
U.S.C. 941); Sections. 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
(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), or 5–2007 (72
FR 31160) as applicable; 29 CFR Part 1911.
Section 1915.120 and 1915.152 of 29 CFR
also issued under 29 CFR part 1911.
(8) Signs.
(i) Warning signs that demarcate the
regulated area shall be provided and
displayed at each location where a
regulated area is required to be
established by paragraph (e) of this
section. Signs shall be posted at such a
distance from such a location that an
employee may read the signs and take
necessary protective steps before
entering the area marked by the signs.
(ii) The warning signs required by this
paragraph shall bear the following
legend:
DANGER
ASBESTOS
Subpart Z—[Amended]
MAY CAUSE CANCER
34. Amend § 1915.1001 to revise
paragraphs (i)(3), (k)(7), and (k)(8) to
read as follows:
CAUSES DAMAGE TO LUNGS
§ 1915.1001
Asbestos.
*
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AUTHORIZED PERSONNEL ONLY
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(i) * * *
(3) The employer shall ensure that
contaminated clothing is transported in
sealed impermeable bags, or other
closed, impermeable containers, and
labeled in accordance with paragraph
(k) of this section.
*
*
*
*
*
(k) * * *
(7) Hazard Communication.
(i) Labels shall be affixed to all
products containing asbestos and to all
containers containing such products,
including waste containers. Where
feasible, installed asbestos products
shall contain a visible label.
(ii) General—The employer shall
include asbestos in the program
established to comply with the Hazard
Communication Standard (HCS) (29
CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of asbestos and
safety data sheets, and is trained in
accordance with the provisions of the
HCS and paragraph (k)(9) of this section.
The employer shall ensure that at least
the following hazards are addressed:
Cancer and lung effects.
(iii) The provisions for labels required
in this paragraph do not apply where:
(A) Asbestos fibers have been
modified by a bonding agent, coating,
binder, or other material, provided that
the manufacturer can demonstrate that,
during any reasonably foreseeable use,
handling, storage, disposal, processing,
or transportation, no airborne
concentrations of asbestos fibers in
excess of the permissible exposure limit
and/or excursion limit will be released,
or
(B) Asbestos is present in a product in
concentrations less than 1.0 percent.
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(iii) In addition, where the use of
respirators and protective clothing is
required in the regulated area under this
section, the warning signs shall include
the following:
WEAR RESPIRATORY PROTECTION
AND PROTECTIVE CLOTHING IN THIS
AREA
(iv) The employer shall ensure that
employees working in and contiguous to
regulated areas comprehend the
warning signs required to be posted by
this paragraph. Means to ensure
employee comprehension may include
the use of foreign languages,
pictographs, and graphics.
(v) When a building/vessel owner or
employer identifies previously installed
PACM and/or ACM, labels or signs shall
be affixed or posted so that employees
will be notified of what materials
contain PACM and/or ACM. The
employer shall attach such labels in
areas where they will clearly be noticed
by employees who are likely to be
exposed, such as at the entrance to
mechanical room/areas. Signs required
by paragraph (k)(6) of this section may
be posted in lieu of labels so long as
they contain information required for
labeling. The employer shall ensure, to
the extent feasible, that employees who
come in contact with these signs or
labels can comprehend them. Means to
ensure employee comprehension may
include the use of foreign languages,
pictographs, graphics, and awareness
training.
*
*
*
*
*
35. Amend § 1915.1026 to revise
paragraphs (g)(2)(iv) and (j)(1) to read as
follows:
§ 1915.1026
*
*
*
(g) * * *
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Frm 00265
Chromium (VI).
*
Fmt 4701
*
Sfmt 4702
50543
(2) * * *
(iv) The employer shall ensure that
bags or containers of contaminated
protective clothing or equipment that
are removed from change rooms for
laundering, cleaning, maintenance, or
disposal are labeled in accordance with
the requirements of the Hazard
Communication standard, 29 CFR
1910.1200.
*
*
*
*
*
(j) * * *
(1) Hazard communication. The
employer shall include chromium (VI)
in the program established to comply
with the Hazard Communication
Standard (HCS) (29 CFR 1910.1200).
The employer shall ensure that each
employee has access to labels on
containers of chromium (VI) and safety
data sheets, and is trained in accordance
with the provisions of HCS and
paragraph (j)(2) of this section. The
employer shall ensure that at least the
following hazards are addressed:
Cancer; skin sensitization; and eye
irritation .
*
*
*
*
*
PART 1926—SAFETY AND HEALTH
REGULATIONS FOR CONSTRUCTION
Subpart D—[Amended]
36. The authority citation for subpart
D is revised to read as follows:
Authority: Section 107 of the Contract
Work Hours and Safety Standards Act (40
U.S.C. 3704); Sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, and 657); and 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), or 5–2007
(72 FR 31159), as applicable; and 29 CFR part
1911.
Sections 1926.58, 1926.59, 1926.60, and
1926.65 also issued under 5 U.S.C. 553 and
29 CFR part 1911.
Section 1926.62 of 29 CFR also issued
under section 1031 of the Housing and
Community Development Act of 1992 (42
U.S.C. 4853).
Section 1926.65 of 29 CFR also issued
under section 126 of the Superfund
Amendments and Reauthorization Act of
1986, as amended (reprinted at 29 U.S.C.A.
655 Note), and 5 U.S.C. 553.
37. Amend § 1926.60 to revise
paragraph (j)(2)(v), (l)(1), and (l)(2) to
read as follows:
§ 1926.60
Methylenedianiline.
*
*
*
*
*
(j) * * *
(2) * * *
(v) Containers of MDA-contaminated
protective work clothing or equipment
that are to be taken out of
decontamination areas or the workplace
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Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Proposed Rules
for cleaning, maintenance, or disposal,
shall bear labels warning of the hazards
of MDA. The employer shall ensure that
labels are consistent with requirements
in paragraph (l) and that labels include
at least the following information:
DANGER: CLOTHING AND
EQUIPMENT CONTAMINATED WITH
LEAD. MAY DAMAGE FERTILITY OR
THE UNBORN CHILD
DANGER
DO NOT EAT, DRINK, OR SMOKE
WHEN HANDLING
CONTAINS METHYLENEDIANILINE
(MDA)
CAUSES DAMAGE TO THE CENTRAL
NERVOUS SYSTEM
DO NOT REMOVE DUST BY BLOWING
OR SHAKING
MAY CAUSE CANCER
*
*
*
*
*
(l) * * *
(1) Hazard communication. The
employer shall include MDA in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of MDA and safety
data sheets, and is trained in accordance
with the provisions of HCS and
paragraph (l)(3) of this section. The
employer shall ensure that at least the
following hazards are addressed:
Cancer; liver effects; and skin
sensitization.
(2) The employer shall post and
maintain legible signs demarcating
regulated areas and entrances or access
ways to regulated areas that bear the
following legend:
*
*
*
*
(l) Communication of Hazards
(1) * * *
(i) Hazard communication. The
employer shall include lead in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of lead and safety
data sheets, and is trained in accordance
with the provisions of HCS and
paragraph (l). The employer shall ensure
that at least the following hazards are
addressed: Reproductive/developmental
toxicity; central nervous system effects;
kidney effects; blood effects; and acute
toxicity effects.
*
*
*
*
*
(m) Signs.
(1) General.
(i) The employer shall post the
following warning signs in each work
area where an employees exposure to
lead is above the PEL.
DANGER
DANGER LEAD
MDA
MAY DAMAGE FERTILITY OR THE
UNBORN CHILD
CAUSES DAMAGE TO THE LIVER
*
MAY CAUSE CANCER
CAUSES DAMAGE TO THE CENTRAL
NERVOUS SYSTEM
CAUSES DAMAGE TO THE LIVER
RESPIRATORY PROTECTION AND
PROTECTIVE CLOTHING MAY BE
REQUIRED IN THIS AREA
AUTHORIZED PERSONNEL ONLY
*
*
*
*
*
38. Amend § 1926.62 to revise
paragraph (g)(2)(vii), the heading of
paragraph (l) and paragraph (l)(1)(i) and
paragraph (m) to read as follows:
§ 1926.62
Lead.
srobinson on DSKHWCL6B1PROD with PROPOSALS2
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*
*
*
*
(g) * * *
(2) * * *
(vii) The employer shall ensure that
the containers of contaminated
protective clothing and equipment
required by paragraph (g)(2)(v) of this
section are labeled as follows:
DO NOT EAT, DRINK OR SMOKE IN
THIS AREA
(ii) The employer shall ensure that no
statement appears on or near any sign
required by this paragraph that
contradicts or detracts from the meaning
of the required sign.
(iii) The employer shall ensure that
signs required by this paragraph are
illuminated and cleaned as necessary so
that the legend is readily visible.
(iv) The employer may use signs
required by other statutes, regulations or
ordinances in addition to, or in
combination with, signs required by this
paragraph.
(2) [Reserved]
*
*
*
*
*
39. Amend § 1926.64 to revise
paragraphs (a)(1)(ii) introductory text
and (a)(1)(ii)(B) to read as follows:
§ 1926.64 Process safety management of
highly hazardous chemicals.
*
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*
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*
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*
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(a) * * *
(1) * * *
(ii) A process which involves a
Category 1 flammable gas (as defined in
1910.1200 (c) or flammable liquid with
a flashpoint below 100 °F (37.8 °C) on
site in one location, in a quantity of
10,000 pounds (4535.9 kg) or more
except for:
*
*
*
*
*
(B) Flammable liquids with a
flashpoint below 100 °F (37.8 °C) stored
in atmospheric tanks or transferred that
are kept below their normal boiling
point without benefit of chilling or
refrigeration.
*
*
*
*
*
40. Amend § 1926.65 (a)(3) to revise
the definition of ‘‘Health hazard’’ to
read as follows:
§ 1926.65 Hazardous waste operations and
emergency response.
(a) * * *
(3) * * *
Health hazard means a chemical or a
pathogen where acute or chronic health
effects may occur in exposed
employees. It also includes stress due to
temperature extremes. The term ‘‘health
hazard’’ includes chemicals that are
classified in accordance with the Hazard
Communication Standard, 29 CFR
1910.1200, as posing one of the
following effects: acute toxicity (any
route of exposure); skin corrosion or
irritation; serious eye damage or eye
irritation; respiratory or skin
sensitization; germ cell mutagenicity;
carcinogenicity; reproductive toxicity;
target organ specific systemic toxicity
(single or repeated dose); or aspiration
toxicity.
*
*
*
*
*
Subpart F—[Amended]
41. Revise the authority citation for
subpart F to read as follows:
Authority: Section 3704 of the Contract
Work Hours and Safety Standards Act (40
U.S.C. 3701 et seq.); Sections 4, 6, and 8,
Occupational Safety and Health Act of 1970
(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 (62 FR
50017), 5–2002 (67 FR 650008), or 5–2007
(72 FR 31159), as applicable; and 29 CFR part
1911.
42. Amend § 1926.152 as follows:
A. Revise the section heading;
B. Remove the words ‘‘and
combustible’’ from the first sentence in
paragraphs (a)(1), (b) introductory text,
(b)(2) introductory text, and (b)(4)(viii);
C. Remove the words ‘‘or
combustible’’ in paragraphs (a)(2), (b)(1),
(b)(4)(iii), (b)(5), (c)(3), (d) introductory
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Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Proposed Rules
text, (d)(1), (d)(4), (e)(1), (e)(3), (f)(2),
(g)(1), (g)(8), (i)(1)(i)(D), (i)(1)(i)(F),
(i)(1)(iii)(D), (i)(2)(ii)(A), (i)(2)(ii) (D),
(i)(2)(ii)(F), (i)(2)(vii)(B)(2), (i)(4)(iv)(C),
(i)(5)(vi)(A),(i)(5(vi)(D), (i)(5)(vi)(G),
(i)(5)(vi)(V) introductory text,
(i)(5)(vi)(V)(1); (j)(1)(i), (j)(2)(ii), (j)(5),
and (k)(4);
D. Amend the fifth sentence of
paragraph (b)(4)(vi) by inserting the
words ‘‘Category 1, 2, or 3’’ in front of
the words ‘‘flammable liquids;’’
E. Amend the first sentence of
paragraphs (e)(2); (e)(5); (g)(7)(i);
(g)(7)(ii); by inserting the words
‘‘Category 1, 2, or 3’’ in front of the
words ‘‘flammable liquids;’’
F. Amend the first sentence of
paragraphs (f)(1) and (f)(3) by removing
‘‘Flammable liquids’’ and inserting
‘‘Category 1, 2, or 3 flammable liquids’’
in its place;
G. Revise paragraphs (b)(2)(iii), (b)(3),
(h) introductory text, (i)(2)(iv)(F),
(i)(2)(iv)(G), (i)(2)(vi)(B), (i)(2)(viii)(E),
(i)(3)(i), (i)(3)(iv)(A) and (C), (i)(3)(v)(D),
(i)(4)(iv)(E), and (k)(3)(iv).; and
(H) Amend paragraph (k)(3)(i) by
revising Table F–19.
The revisions read as follows:
§ 1926.152
Flammable liquids.
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*
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(b) * * *
(2) * * *
(iii) Cabinets shall be labeled in
conspicuous lettering, ‘‘FlammableKeep Away from Open Flames.’’
(3) Not more than 60 gallons of
Category 1, 2 and 3 flammable liquids
or 120 gallons of Category 4 flammable
liquids shall be stored in any one
storage cabinet. Not more than three
such cabinets may be located in a single
storage area. Quantities in excess of this
shall be stored in an inside storage
room.
*
*
*
*
*
(h) Scope. This section applies to the
handling, storage, and use of flammable
liquids with a flashpoint at or below
199.4 °F (93 °C). This section does not
apply to:
*
*
*
*
*
(i) * * *
(2) * * *
(iv) * * *
(F) Tanks and pressure vessels storing
Category 1 flammable liquids shall be
equipped with venting devices that
shall be normally closed except when
venting to pressure or vacuum
conditions. Tanks and pressure vessels
storing Category 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), shall
be equipped with venting devices that
shall be normally closed except when
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23:10 Sep 29, 2009
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venting under pressure or vacuum
conditions, or with approved flame
arresters. ‘‘Exemption to paragraph
(i)(2)(iv)(F):’’ Tanks of 3,000 bbls (84
m(3)) capacity or less containing crude
petroleum in crude-producing areas;
and, outside aboveground atmospheric
tanks under 1,000 gallons (3,785 L)
capacity containing other than Category
1 flammable liquids may have open
vents. (See paragraph (i)(2)(vi)(B) of this
section.)
(G) Flame arresters or venting devices
required in paragraph (i)(2)(iv)(F) of this
section may be omitted for Category 2
flammable liquids or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C) where conditions
are such that their use may, in case of
obstruction, result in tank damage.
*
*
*
*
*
(vi) * * *
(B) Where vent pipe outlets for tanks
storing Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
are adjacent to buildings or public ways,
they shall be located so that the vapors
are released at a safe point outside of
buildings and not less than 12 feet
(3.658 m) above the adjacent ground
level. In order to aid their dispersion,
vapors shall be discharged upward or
horizontally away from closely adjacent
walls. Vent outlets shall be located so
that flammable vapors will not be
trapped by eaves or other obstructions
and shall be at least 5 feet (1.52 m) from
building openings.
(viii) * * *
(E) For Category 2 flammable liquids
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), other
than crude oils, gasolines, and asphalts,
the fill pipe shall be so designed and
installed as to minimize the possibility
of generating static electricity. A fill
pipe entering the top of a tank shall
terminate within 6 inches (15.24 cm) of
the bottom of the tank and shall be
installed to avoid excessive vibration.
*
*
*
*
*
(3) * * *
(i) Location. Evacuation for
underground storage tanks shall be
made with due care to avoid
undermining of foundations of existing
structures. Underground tanks or tanks
under buildings shall be so located with
respect to existing building foundations
and supports that the loads carried by
the latter cannot be transmitted to the
tank. The distance from any part of a
tank storing Category 1 or 2 flammable
liquids, or Category 3 flammable liquids
with a flashpoint below 100 °F (37.8 °C),
to the nearest wall of any basement or
pit shall be not less than 1 foot (0.304
PO 00000
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Fmt 4701
Sfmt 4702
50545
m), and to any property line that may
be built upon, not less than 3 feet (0.912
m). The distance from any part of a tank
storing Category 3 flammable liquids
with a flashpoint at or above to 100 °F
(37.8 °C) or Category 4 flammable
liquids to the nearest wall of any
basement, pit or property line shall be
not less than 1 foot (0.304 m).
*
*
*
*
*
(iv) * * *
(A) Location and arrangement of vents
for Category 1 or 2 flammable liquids, or
Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C). Vent
pipes from tanks storing Category 1 or
2 flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall be so
located that the discharge point is
outside of buildings, higher than the fill
pipe opening, and not less than 12 feet
(3.658 m) above the adjacent ground
level. Vent pipes shall discharge only
upward in order to disperse vapors.
Vent pipes 2 inches (5.08 cm) or less in
nominal inside diameter shall not be
obstructed by devices that will cause
excessive back pressure. Vent pipe
outlets shall be so located that
flammable vapors will not enter
building openings, or be trapped under
eaves or other obstructions. If the vent
pipe is less than 10 feet (3.04 m) in
length, or greater than 2 inches (5.08
cm) in nominal inside diameter, the
outlet shall be provided with a vacuum
and pressure relief device or there shall
be an approved flame arrester located in
the vent line at the outlet or within the
approved distance from the outlet.
(B) * * *
(C) Location and arrangement of vents
for Category 3 flammable liquids with a
flashpoint at or above 100 °F (37.8 °C)
or Category 4 flammable liquids. Vent
pipes from tanks storing Category 3 with
a flashpoint at or above 100 °F (37.8 °C)
or Category 4 flammable liquids shall
terminate outside of the building and
higher than the fill pipe opening. Vent
outlets shall be above normal snow
level. They may be fitted with return
bends, coarse screens or other devices to
minimize ingress of foreign material.
*
*
*
*
*
(v) * * *
(D) For Category 2 flammable liquids
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), other
than crude oils, gasolines, and asphalts,
the fill pipe shall be so designed and
installed as to minimize the possibility
of generating static electricity by
terminating within 6 inches (15.24 cm)
of the bottom of the tank.
*
*
*
*
*
(4) * * *
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(iv) * * *
(E) For Category 2 flammable liquids
or Category 3 flammable liquids with a
flashpoint below 100 °F (37.8 °C), other
than crude oils, gasolines, and asphalts,
the fill pipe shall be so designed and
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installed as to minimize the possibility
of generating static electricity by
terminating within 6 inches (15.24 cm)
of the bottom of the tank.
*
*
*
*
*
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(k) * * *
(3) * * *
(i) * * *
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*
*
*
*
(iv) Piping handling Category 1 or 2
flammable liquids, or Category 3
flammable liquids with a flashpoint
below 100 °F (37.8 °C), shall be
grounded to control stray currents.
*
*
*
*
*
43. Amend § 1926.155 as follows:
A. Remove and reserve paragraph (c);
B. Revise paragraphs (h) and (i)(1) and
(2).
The revisions read as follows:
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*
§ 1926.155
subpart.
Definitions applicable to this
*
*
*
*
*
(h) Flammable liquid means any
liquid having a vapor pressure not
exceeding 40 pounds per square inch
(absolute) at 100 °F and having a
flashpoint at or below 199.4 °F (93 °C).
Flammable liquids are divided into four
categories as follows:
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Category 1 shall include liquids
having flashpoints below 73.4 °F (23 °C)
and having a boiling point at or below
95 °F (35 °C).
Category 2 shall include liquids
having flashpoints below 73.4 °F (23 °C)
and having a boiling point above 95 °F
(35 °C).
Category 3 shall include liquids
having flashpoints at or above 73.4 °F
(23 °C) and at or below 140 °F (60 °C).
Category 4 shall include liquids
having flashpoints above 140 °F (60 °C)
and at or below 199.4 °F (93 °C).
(i) * * *
(1) The flashpoint of liquids having a
viscosity less than 45 Saybolt Universal
Second(s) at 100 °F (37.8 °C) and a
flashpoint below 175 °F (79.4 °C) shall
be determined in accordance with the
Standard Method of Test for Flash Point
by the Tag Closed Tester, ASTM D–56–
69 or an equivalent method as defined
by 1910.1200 appendix B.
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(2) The flashpoints of liquids having
a viscosity of 45 Saybolt Universal
Second(s) or more at 175 °F (79.4 °C) or
higher shall be determined in
accordance with the Standard Method
of Test for Flash Point by the Pensky
Martens Closed Tester, ASTM D–93–69
or an equivalent method as defined by
1910.1200 appendix B.
*
*
*
*
*
Subpart Z—[Amended]
44. Revise the authority citation for
subpart Z to read as follows:
Authority: Section 3704 of the Contract
Work Hours and Safety Standards Act (40
U.S.C. 3701 et seq.); Sections 4, 6, and 8 of
the Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657); and 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), or 5–2007
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(72 FR 31159), as applicable; and 29 CFR part
1911.
Sections 1926.1101 and 1926.1127 also
issued under 5 U.S.C. 553.
Section 1926.1102 of 29 CFR not issued
under 29 U.S.C. 655 or 29 CFR part 1911;
also issued under 5 U.S.C. 553.
CAUSES DAMAGE TO LUNGS
DO NOT BREATH DUST
Asbestos.
*
*
*
*
*
(k) * * *
(1) Hazard communication.
*
*
*
*
*
(ii) The employer shall include
asbestos in the program established to
comply with the Hazard
Communication Standard (HCS) (29
CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of asbestos and
safety data sheets, and is trained in
accordance with the provisions of HCS
and paragraphs (k)(9) and (10) of this
section. The employer shall provide
information on at least the following
hazards: Cancer and lung effects
*
*
*
*
*
(7) * * *
(ii)(A) The warning signs required by
paragraph (k)(7) of this section shall
bear the following information.
DANGER
ASBESTOS
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
(B) In addition, where the use of
respirators and protective clothing is
required in the regulated area under this
section, the warning signs shall include
the following:
srobinson on DSKHWCL6B1PROD with PROPOSALS2
WEAR RESPIRATORY PROTECTION
AND PROTECTIVE CLOTHING IN THIS
AREA
*
*
*
*
*
(8) * * *
(ii) The employer shall ensure that
such labels comply with paragraphs (k).
(iii) The employer shall ensure that
labels of bags or containers of protective
clothing and equipment, scrap, waste,
and debris containing asbestos fibers
bear the following information:
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CONTAINS ASBESTOS FIBERS
MAY CAUSE CANCER
45. Amend § 1926.1101 as follows:
A. Redesignate paragraph (k)(1) as
(k)(1)(i) and add a new heading to
paragraph (k)(1);
B. Add new paragraph (k)(1)(ii);
C. Amend paragraphs (k)(2)(i) and
(k)(3)(i) by changing the reference in the
last line from ‘‘(k)(1)’’ to ‘‘(k)(1)(i);’’
D. Revise paragraphs (k)(7)(ii)(A) and
(B), and (k)(8)(ii) and (iii).
The additions and revisions read as
follows:
§ 1926.1101
DANGER
*
*
*
*
*
46. Amend § 1926.1126 to revise
paragraphs (g)(2)(iv) and (j)(1) to read as
follows:
§ 1926.1126
Chromium.
*
*
*
*
*
(g) * * *
(2) * * *
(iv) The employer shall ensure that
bags or containers of contaminated
protective clothing or equipment that
are removed from change rooms for
laundering, cleaning, maintenance, or
disposal shall be labeled in accordance
with the requirements of the Hazard
Communication Standard, 29 CFR
1910.1200. The employer shall ensure
that the labels state the following
hazards: Cancer, eye irritation, and skin
sensitization.
*
*
*
*
*
(j) * * *
(1) Hazard communication. The
employer shall include chromium (VI)
in the program established to comply
with the Hazard Communication
Standard (HCS) (29 CFR 1910.1200).
The employer shall ensure that each
employee has access to labels on
containers of chromium and safety data
sheets, and is trained in accordance
with the provisions of 29 CFR
1910.1200 and paragraph (j)(2) of this
section. The employer shall provide
information on at least the following
hazards: Cancer; skin sensitization; and
eye irritation.
*
*
*
*
*
47. Amend § 1926.1127 to revise
paragraphs (i)(2)(iv), (k)(7), and (m)(1),
(m)(2)(ii), and (m)(3)(i) and (ii).
The revisions read as follows:
§ 1926.1127
Cadmium.
*
*
*
*
*
(i) * * *
(2) * * *
(iv) The employer shall ensure that
containers of contaminated personal
protective clothing and equipment that
are to be taken out of the change rooms
or the workplace for laundering,
cleaning, maintenance or disposal shall
bear labels in accordance with
paragraph (m) of this section. As a
minimum, labels on containers of
contaminated protective clothing and
equipment must state MAY CAUSE
CANCER, CAUSES DAMAGE TO
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LUNGS AND KIDNEYS. AVOID
CREATING DUST.
*
*
*
*
*
(k) * * *
(7) Waste, scrap, debris, bags, and
containers, personal protective
equipment and clothing contaminated
with cadmium and consigned for
disposal shall be collected and disposed
of in sealed impermeable bags or other
closed, impermeable containers. These
bags and containers shall be labeled in
accordance with paragraph (i)(2)(iv) of
this section.
*
*
*
*
*
(m) * * *
(1) Hazard communication. The
employer shall include cadmium in the
program established to comply with the
Hazard Communication Standard (HCS)
(29 CFR 1910.1200). The employer shall
ensure that each employee has access to
labels on containers of cadmium and
safety data sheets, and is trained in
accordance with the provisions of HCS
and paragraph (m)(4) of this section.
The employer shall provide information
on at least the following hazards:
Cancer; lung effects; kidney effects; and
acute toxicity effects
(2) * * *
(ii) Warning signs required by
paragraph (m)(2)(i) of this section shall
bear the following information:
DANGER
CADMIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS AND
KIDNEYS
WEAR RESPIRATORY PROTECTION IN
THIS AREA
AUTHORIZED PERSONNEL ONLY
(iii) * * *
(3) * * *
(i) Shipping and storage containers
containing cadmium and cadmium
compounds shall bear appropriate
warning labels, as specified in
paragraph (m)(1) of this section.
(ii) The warning labels for waste,
scrap, or debris shall include at least the
following information:
DANGER
CONTAINS CADMIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS AND
KIDNEYS
CAN CAUSE LUNG AND KIDNEY
DISEASE
AVOID CREATING DUST
*
*
*
*
*
[FR Doc. E9–22483 Filed 9–29–09; 8:45 am]
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Agencies
[Federal Register Volume 74, Number 188 (Wednesday, September 30, 2009)]
[Proposed Rules]
[Pages 50280-50549]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22483]
[[Page 50279]]
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Part II
Department of Labor
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Occupational Safety and Health Administration
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29 CFR Parts 1910, 1915, and 1926
Hazard Communication; Proposed Rule
Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 /
Proposed Rules
[[Page 50280]]
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910, 1915, and 1926
[Docket No. OSHA-H022K-2006-0062 (formerly Docket No. H022K)]
RIN 1218-AC20
Hazard Communication
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Proposed rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: OSHA is proposing to modify its existing Hazard Communication
Standard (HCS) to conform with the United Nations' (UN) Globally
Harmonized System of Classification and Labelling of Chemicals (GHS).
OSHA has made a preliminary determination that the proposed
modifications will improve the quality and consistency of information
provided to employers and employees regarding chemical hazards and
associated protective measures. The Agency anticipates this improved
information will enhance the effectiveness of the HCS in ensuring that
employees are apprised of the chemical hazards to which they may be
exposed, and in reducing the incidence of chemical-related occupational
illnesses and injuries.
The proposed modifications to the standard include revised criteria
for classification of chemical hazards; revised labeling provisions
that include requirements for use of standardized signal words,
pictograms, hazard statements, and precautionary statements; a
specified format for safety data sheets; and related revisions to
definitions of terms used in the standard, requirements for employee
training on labels and safety data sheets. OSHA is also proposing to
modify provisions of a number of other standards, including standards
for flammable and combustible liquids, process safety management, and
most substance-specific health standards, to ensure consistency with
the modified HCS requirements.
DATES: Written comments. Written comments, including comments on the
information collection determination described in Section VIII of the
preamble (OMB Review under the Paperwork Reduction Act of 1995), must
be submitted by the following dates:
Hard copy: Comments must be submitted (postmarked or sent) by
December 29, 2009.
Facsimile and electronic transmissions: Comments must be sent by
December 29, 2009.
Informal public hearings. The Agency will schedule an informal
public hearing on the proposed rule. 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 by any of the
following methods:
Electronically: You may submit comments electronically at https://www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
the instructions on-line for making electronic submissions.
Fax: If your submissions, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
Mail, hand delivery, express mail, messenger or courier service:
You must submit three copies of your comments to the OSHA Docket
Office, Docket No. OSHA-H022K-2006-0062, U.S. Department of Labor, Room
N-2625, 200 Constitution Avenue, NW., Washington, DC 20210. Deliveries
(hand, express mail, messenger and courier service) are accepted during
the Department of Labor's and Docket Office's normal business hours,
8:15 a.m.-4:45 p.m., E.T.
Instructions: All submissions must include the Agency name and the
docket number for this rulemaking (Docket No. OSHA-H022K-2006-0062).
All comments, including any personal information you provide, are
placed in the public docket without change and may be made available
online at https://www.regulations.gov. Therefore, OSHA cautions you
about submitting personal information such as social security numbers
and birthdates.
Docket: To read or download comments submitted in response to this
Federal Register notice, go to Docket No. OSHA-H022K-2006-0062 at
https://www.regulations.gov or to the OSHA Docket Office at the address
above. All comments are listed in the https://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through that Web page. All comments,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office.
Electronic copies of this Federal Register document are available
at https://regulations.gov. Copies also are available from the OSHA
Office of Publications, Room N-3101, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
1888. This document, as well as news releases and other relevant
information, are also available at OSHA's Web page at https://www.osha.gov.
FOR FURTHER INFORMATION CONTACT: For general information and press
inquiries, contact Jennifer Ashley, Office of Communications, Room N-
3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone (202) 693-1999. For technical
information, contact Maureen O'Donnell, Directorate of Standards and
Guidance, Room N-3718, OSHA, U.S. Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210; telephone (202) 693-1950.
SUPPLEMENTARY INFORMATION:
I. Introduction
The preamble to the proposal to modify the Hazard Communication
Standard 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 provisions set
forth in the proposed standard. The discussion follows this outline:
I. Introduction
II. Issues
III. Events Leading to the Proposed Modifications to the Hazard
Communication Standard
IV. Overview and Purpose of the Proposed Modifications to the Hazard
Communication Standard
V. Need and Support for the Proposed Modifications to the Hazard
Communication Standard
VI. Pertinent Legal Authority
VII. Preliminary Economic Analysis and Initial Regulatory
Flexibility Analysis
VIII. OMB Review Under the Paperwork Reduction Act of 1995
IX. Federalism
X. State Plans
XI. Unfunded Mandates
XII. Protecting Children From Environmental Health and Safety Risks
XIII. Environmental Impacts
XIV. Public Participation
XV. Summary and Explanation of the Proposed Modifications to the
Hazard Communication Standard
(a) Purpose
(b) Scope
(c) Definitions
(d) Hazard Classification
(e) Written Hazard Communication Program
(f) Labels and Other Forms of Warning
(g) Safety Data Sheets
[[Page 50281]]
(h) Employee Information and Training
(i) Trade Secrets
(j) Effective Dates
(k) Other Standards Affected
(l) Appendices
XVI. References
XVII. Authority and Signature
XVIII. Proposed Amendments
In the preamble, OSHA references a number of supporting materials.
References to these materials are given as ``Document ID''
followed by the last four digits of the document number. The referenced
materials are posted in Docket No. OSHA-H022K-2006-0062 (which is
available at https://www.regulations.osha.gov). The documents are also
available at the OSHA Docket Office (see ADDRESSES section above). For
further information about accessing documents referenced in this
Federal Register notice, see Section XIV (Public Participation--Notice
of Hearing).
II. Issues
OSHA requests comment on all relevant issues, including economic
impact and feasibility, environmental impact, effects on small
entities, proposed revisions to the HCS, and subsequent modifications
to other standards. OSHA has received many comments on the issues
raised in the Advance Notice of Proposed Rulemaking (ANPR) (71 FR
53617, September 12, 2006), and the Agency has considered those
comments in the development of this proposal. This section identifies
issues on which the Agency seeks additional information and comment to
supplement that received in response to the ANPR, as well as new topics
related to this proposal. While new comments are welcome, OSHA requests
that comments submitted in response to the ANPR not be resubmitted as
they are retained in the rulemaking record and reconsidered throughout
the process.
OSHA is including these issues at the beginning of the document to
assist readers as they consider the comments they plan to submit.
However, to fully understand the questions and provide substantive
input in response to them, the parts of the preamble that address these
issues in detail should be read and reviewed. These include Section
VII, which addresses the impacts of the NPRM, and thus provides the
background related questions 2 through 5. Section XV provides the
Summary and Explanation of the proposed regulatory text, and Section
XVII is the text itself. These are key to understanding questions 6
through 26. It should be noted that the Federal Register's required
format for a modification of an existing standard does not allow the
Agency to provide the full text of the rule, i.e., the regulatory text
in this document only addresses those paragraphs that OSHA is proposing
to change. Therefore, the Agency is putting a marked up version of the
text of the current rule on its web page to help readers understand the
proposed changes in context. The marked up text will be found on
www.osha.gov under Hazard Communication in the subject index.
OSHA requests that comments be organized, to the extent possible,
around the following issues and numbered questions. Submitting comments
in an organized manner and with clear reference to the issue raised
will enable all participants to easily see what issues the commenter
addressed and how they were addressed. This is particularly important
in a rulemaking such as GHS which affects many diverse industries. Many
commenters, especially small businesses, are likely to confine their
interest (and comment) to the issues that affect them, and they will
benefit from being able to quickly identify comment on their issues in
others' submissions. Of course, OSHA also welcomes relevant comments
concerning the proposal that fall outside the issue questions raised in
this section. However, the Agency is particularly interested in
receiving public responses, supported by evidence and reasons, to the
following questions:
Need and Support for the Standard
1. OSHA has made a preliminary determination that the proposed
modifications to the HCS would increase the quality and consistency of
information provided to employers and employees. Specifically, OSHA
believes that standardized label elements would be more effective in
communicating hazard information; standardized headings and a
consistent order of information would improve the utility of SDSs; and
training would support and enhance the effectiveness of the new label
and SDS requirements. Is this assessment correct? OSHA requests
information that reflects on the effectiveness of the proposed
modifications to the HCS in protecting employees from chemical hazards
in the workplace.
Economic Impacts and Economic Feasibility
2. The preliminary economic analysis in Section VII raises a
variety of specific questions and issues with respect to the
preliminary economic analysis. OSHA would appreciate it if you could
place answers to these issues as heading 2 in your comments and further
organize comments on the preliminary economic analysis (PEA) as
follows:
a. Industrial profiles. This covers issues concerning how many
employees, establishments and products would be affected by the
proposed standard. OSHA welcomes comments on all aspects of the
industrial profile and is particularly interested in comments on the
number of affected employees, and the number of SDSs that would need
revision, by industry.
b. Issues with respect to estimated benefits of the proposed
standard. OSHA considers three kinds of benefits in this preliminary
analysis: Benefits associated with preventing injuries, illnesses, and
fatalities through clearer and more accessible information; benefits
associated with reducing the time that safety and health managers and
logistics and emergency response personnel spend on hazardous chemicals
through clearer and easier-to-find information; and benefits associated
with reducing the time needed to develop and review SDSs because of
international harmonization. OSHA is particularly interested in
comments on the scope of these benefits; the extent to which they are
already being achieved by existing practices; and the extent to which
they depend on other countries following the harmonization effort.
c. Issues with respect to the costs and range of costs of the
proposed standard. OSHA preliminarily estimated the principal costs of
the standard to chemical producers for reclassification of chemicals;
remaking SDS's; and redoing labels; and to chemical users for
familiarization and program changes for managers and for training
exposed employees. OSHA welcomes comments on all aspects of the costs,
and is particularly interested in comments on the extent to which
chemical producers may have already met some of the requirements of the
standard and the time and professional skills needed for the activities
the standard would require.
d. Issues with respect to economic impacts and feasibility of the
proposed standard, including the sensitivity of OSHA's economic
feasibility determination with respect to various assumptions. OSHA
welcomes comments on all aspects of the economic impact and economic
feasibility analyses.
e. All other issues with respect to the PEA.
Effects on Small Entities
3. OSHA has certified that the proposed standard will not have a
[[Page 50282]]
significant impact on a substantial number of small entities.
Nevertheless, because of the number of small entities affected, OSHA
has prepared a voluntary initial regulatory flexibility analysis, the
results of which are described in Section VII of the proposed rule. Do
you consider the estimated costs and impacts on small entities
presented there to be reasonable? Why or why not?
4. Are there alternatives to the rule as a whole or specific
requirements of the rule that reduce impacts on small entities while
still protecting the health of employees and meeting the broad goal of
a globally harmonized system?
Environmental Impacts
5. OSHA has preliminarily determined that the proposed standard
will not have any adverse effects on the environment, and may have
positive effects on the environment. OSHA welcomes comments on this
determination.
Hazard Classification
6. OSHA is proposing to adopt all of the physical and health hazard
classes in the GHS. Among the physical and health hazard classes, OSHA
is proposing to include all hazard categories in the GHS except Acute
Toxicity Category 5 for oral, dermal, or inhalation exposures; Skin
Corrosion/Irritation Category 3; and Aspiration Hazard Category 2. If
you believe that the exclusion of these hazard categories is not
consistent with the scope and/or level of protection provided by the
current HCS, please describe any recommended changes to this proposal
and the reasons you think these changes are necessary.
7. OSHA has proposed a definition for unclassified hazards be added
to the HCS to ensure that all hazards currently covered by the HCS--or
new hazards that are identified in the future--are included in the
scope of the revised standard until such time as specific criteria for
the effect are added to the GHS and subsequently adopted by OSHA. Will
this approach provide sufficient interim coverage for hazards such as
combustible dust? Are there other hazards for which criteria should be
developed and added to the GHS? Please provide information regarding
these hazards, and the information available to characterize them.
8. OSHA believes it may be more appropriate to add specific
coverage for simple asphyxiants to the standard in the final rule to
ensure everyone properly addresses their coverage rather than
addressing them under the unclassified hazard definition. This effect
is simple and straightforward, and could be addressed in a definition
that does not involve extensive criteria. OSHA is requesting comment on
this approach. A possible definition would be as follows:
``Simple asphyxiants'' are substances that displace oxygen in
the ambient atmosphere, and can thus cause oxygen deprivation in
exposed workers that leads to unconsciousness and death. They are of
particular concern in confined spaces. Examples of asphyxiants
include: nitrogen, helium, argon, propane, neon, carbon dioxide, and
methane.
OSHA would also like to solicit comments on specific label elements
for simple asphyxiants. No symbol would be required, but the signal
word ``warning'' would be used, with the hazard statement ``may be
harmful if inhaled''. In addition, a precautionary statement such as
the following would be required: May displace oxygen in breathing air
and lead to suffocation and death, particularly in confined spaces.
All other requirements of the standard that apply to hazardous
chemicals would also apply to chemicals that meet this definition.
These substances would generally be covered already under the proposed
rule as compressed gases, and may also pose other effects such as
flammability that would have to be addressed as well. They are also
already covered under the existing HCS. Is the definition suggested by
OSHA sufficient to cover this effect? Do you have suggestions for
modifying this definition? Are the label elements suggested
appropriate?
9. In order to help to ensure that health hazard determinations are
properly conducted under a performance-oriented approach, the HCS
includes a ``floor'' of chemicals that are to be considered hazardous
based on several cited reference lists. In addition, the existence of
one toxicological study indicating a possible adverse effect is
considered sufficient for a finding of hazard for any health effect.
Under the GHS, there is no floor of chemicals cited, nor is there an
across-the-board provision such as the one-study criterion. Instead,
specific, detailed criteria are provided for each type of health hazard
to guide the evaluation of relevant data and subsequent classification
of the chemical. The proposed modifications to the HCS would align the
standard to the GHS approach, and thus do not include the floor of
chemicals nor the universal one-study rule. Would the proposed detailed
criteria provide sufficient guidance for a thorough hazard evaluation?
10. OSHA has edited the chapters in the GHS for classification of
physical and health hazards to remove material not directly related to
classification and to otherwise streamline the text. OSHA anticipates
providing the decision logics separately to serve as guidance, but has
not included them in the regulatory text. Are there any additions,
subtractions, or clarifications of the classification criteria from the
GHS that OSHA needs to consider?
11. Certain physical hazard classification criteria (i.e., for
self-reactive chemicals, organic peroxides, self-heating chemicals,
explosives) either directly reference packaging or quantity, or rely on
test methods that reference packaging or quantity. The criteria were
developed for transport concerns. Clearly, quantity and packaging can
greatly affect safe transport of chemicals that pose hazards such as
those listed above. However, OSHA seeks comments on whether the
criteria as stated in the GHS are appropriate for the workplace. Does
use of these criteria present any obstacles to classification or create
any difficulties for suppliers or users of chemicals? Describe any
difficulties these criteria may present and any suggestions for
addressing these issues, particularly recommendations that would be
consistent with the GHS and maintain the GHS level of safety for these
chemicals.
12. The GHS gives countries guidance on a cut-off or concentration
limit for chemical mixtures containing target organ toxicity hazards.
In Appendix A, Section A.8.3, OSHA is proposing to make the suggested
20% concentration limit mandatory so that label preparers are clear on
what needs to be done. Please comment on whether this mandatory
concentration limit is appropriate. If you have an alternative, please
provide it along with the rationale.
Labels
13. The proposal would require pictograms to have a red frame. As
discussed in Section V, OSHA believes that use of the color red will
make warnings more noticeable and will aid in communicating the
presence of a hazard. However, the GHS gives competent authorities such
as OSHA the discretion to allow use of a black frame when the pictogram
appears on a label for a package which will not be exported. For
packages that will not be exported, should the modified standard allow
black frames on pictograms, or should the pictogram frame be required
to be presented in red?
[[Page 50283]]
14. In addition to the pictograms, signal word and hazard
statements, GHS labels must include precautionary statements. OSHA is
proposing to require the text in the precautionary statements in the
GHS to be on HCS labels. As discussed in Section XV Summary and
Explanation of the Proposed Standard, these statements are codified
under the GHS, meaning that numbers have been assigned to them. In
addition, the appropriate statements to use for each hazard class and
category have been indicated in the GHS annexes. This means that label
preparers will know exactly what precautionary statements to apply once
they complete their hazard classification, and chemical users will see
consistent language on labels to indicate the necessary precautionary
measures. However, the statements are not yet considered to be part of
the harmonized text like hazard statements are; rather they are
included in the GHS as an suggested language. OSHA expects that other
countries may adopt the codified precautionary statements when they put
GHS in place. For example the EU has required that labels use the GHS
codified precautionary statement text in adapting the GHS. Since OSHA
did not previously require the use of precautionary statements, and had
no such recommended statements to provide, the Agency is proposing to
use those currently in the GHS as the mandatory requirements with the
option of consolidating statements where appropriate (See Appendix C).
OSHA anticipates this approach will provide the maximum benefit. OSHA
is also seeking comment on whether any of these statements should be
modified or if other precautionary statements should be included.
In addition, as discussed in Section IV, OSHA has presented other
alternatives with regards to precautionary statements, and OSHA is
soliciting comment on these options as well. Specifically, OSHA is
seeking feedback on whether the Agency should include the GHS
precautionary statements as nonbinding examples, through a non
mandatory appendix or guidance, rather than as required statements, or
whether OSHA should allow label preparers to develop their own
precautionary statements rather than specifying the text to be used.
15. OSHA has not proposed to require the exploding bomb pictogram
or specific precautionary statements for Division 1.4S ammunition and
ammunition components because the specified GHS label elements may not
accurately reflect the hazards of these materials. Is this sufficiently
protective? Are any adjustments to the label elements for Division 1.4S
ammunition and ammunition components necessary? Describe any requested
changes and explain why such revisions are necessary.
16. In the current HCS, OSHA has a provision that requires labels
to be updated within three months of obtaining new and significant
information about the hazards. The Agency has not been enforcing this
provision for many years, and there has been an administrative stay on
enforcement. OSHA is including the provision in this proposal, and
inviting comment on it with the intention of including it in the final
rule and lifting the stay. Is three months the appropriate time
interval for updating? Are there any practical accommodations that need
to accompany this limit (for example, related to stockpiles of
chemicals)? Provide any alternatives you consider appropriate, as well
as documentation to support them.
Safety Data Sheets (SDSs)
17. As discussed in Section XV, the Agency is proposing to require
that OSHA permissible exposure limits (PELs) be included on the SDS, as
well as any other exposure limit used or recommended by the chemical
manufacturer, importer, or employer preparing the safety data sheet.
OSHA welcomes comments on this approach, along with an explanation of
the basis for your position.
18. OSHA is proposing that Section 15 of the SDS be non-mandatory.
As indicated in Appendix D, Section 15 addresses regulatory information
concerning the chemical. OSHA is considering requiring the substance
specific standards be referenced in this section, which would make
Section 15 mandatory. Would employers and employees benefit from having
this information in this section of the SDS?
Other Standards Affected
19. OSHA is proposing to align the definitions of the physical
hazards to the requirements of the GHS categories in safety standards
for general industry, construction, and maritime standards, which
either directly reference the HCS or provide information pertinent to
the Safety Data Sheets (SDSs). In most cases OSHA has modified the
standards to maintain scope and protection. However, the changes in
definitions for flammable liquids Category 1 and 2 and flammable
aerosols appear to be more than simply rounding to the nearest
significant number.
[cir] Flammable liquids Category 1 and 2: The boiling point cut-off
for Category 1 is reduced from 100 deg F (37.8 deg C) or less to 95 deg
F (35 deg C) or less, which could shift some liquids from Category 1 to
Category 2.
[cir] Flammable aerosols: OSHA is proposing to adopt the GHS method
to determine flammability rather than the method defined by the
Consumer Product Safety Commission (CPSC).
OSHA's decision to change these definitions to be consistent with
the GHS is based not only upon harmonizing its standards with those of
other countries that have adopted or may adopt the GHS, but OSHA is
also concerned with making its standards internally consistent. OSHA
believes the methods used to classify these physical hazards are
similar enough so that substances that are currently regulated by OSHA
would continue to be regulated and that few, if any, changes would
result in a shift in regulatory coverage. Would the proposed changes
have any impact on your operations? If so, describe the anticipated
effects.
20. OSHA is proposing to eliminate the term ``combustible liquid''
in 29 CFR 1910.106. 1910.107, 1910.123, 1910.124, 1910.125, and
1926.155 for liquids with a flashpoint above 100 [deg]F. To reflect
consistency with the revised HCS where appropriate, OSHA is proposing
to add the specific flashpoint criteria. This will maintain equivalent
protection. Are there other standards that OSHA should update with the
new terminology?
21. OSHA is proposing to modify the language required on signs in
substance-specific health standards. The Agency developed the proposed
language to reflect the terminology of the revised HCS while, at the
same time, providing adequate warning through language that is
consistent with the current sign requirements for these chemicals. An
added benefit is the hazard warnings on signs specified for these
standards will now be consistent throughout OSHA standards. For
example, all carcinogens will now bear the hazard statement ``MAY CAUSE
CANCER''. OSHA believes that providing language that is consistent on
both signs and labels will improve comprehension for employees. Does
the proposed language on signs accurately convey the hazards?
22. OSHA is proposing to revise the substance-specific health
standards' provisions on labeling for producers and importers of
chemicals and substances. Currently in the substance-specific standards
OSHA requires specific language on labels for certain chemicals. OSHA
is proposing to change these labeling requirements by referring those
responsible for labeling to the modified HCS and including in each
substance-
[[Page 50284]]
specific standard a list of health effects that must be considered for
hazard classification. The modified HCS will dictate the specific
language (i.e., signal word, hazard statement(s), and precautionary
statement(s)) that is required on labels through the classification
process. However, OSHA is proposing to maintain specific language for
labels on contaminated clothing and waste/debris containers to ensure
adequate hazard communication for the downstream recipients. How would
the removal of required language for labels from substance-specific
standards affect your work place? Are there hazard warnings that will
be lost that do not have an equivalent hazard or precautionary
statement? Are there alternatives to OSHA's approach for the substance-
specific standards that will assure information is disseminated in a
manner that is consistent with the modified HCS labeling requirements?
23. In determining the health hazards that need to be considered by
manufacturers, importers and distributors when classifying chemicals
regulated by the substance-specific standards, OSHA is proposing to
primarily rely on the determinations made by the Agency in each
rulemaking, the NIOSH Pocket Guide to Chemical Hazards (2005) and the
International Chemical Safety Cards, and use as a secondary source the
health effects identified by the European Commission (2007). OSHA is
proposing to include a health hazard only if it is identified as such
by two or more of these organizations. Are there other sources of
information that OSHA should consult?
24. As detailed in the Summary and Explanation section of this
document, OSHA is not proposing in this rulemaking to update the
electrical standards (general industry 1910 subpart S and construction
1926 subpart K) or Explosives and blasting agents (general industry
1910.109 and construction 1926.914). These subparts are ``self-
contained'' in that they do not rely on other OSHA standards for
regulatory scope or definitions, but reference external organizations
(such as the National Fire Protection Association [NFPA]). OSHA
believes that these standards could be updated when the referenced
external organizations adopt applicable GHS elements. If OSHA were to
change these standards to comply with the GHS, how would this impact
your operations?
Effective Dates
25. OSHA has proposed to require that employers train employees
regarding the new labels and safety data sheets within two years after
publication of the final rule to ensure they are familiar with the new
approach when they begin to see new labels and SDSs in their
workplaces. Is the proposed time appropriate?
26. OSHA has proposed that chemical manufacturers, importers,
distributors, and employers be required to comply with all provisions
of the modified final rule within three years after its publication.
Does this allow adequate time to review hazard classifications and
amend them as necessary, and to revise labels and safety data sheets to
reflect the new requirements? Would a shorter time frame be sufficient?
27. Are there any other factors that should be considered in
establishing the phase-in period?
Compliance Assistance and Outreach
28. OSHA received many comments in response to the questions in the
ANPR regarding compliance assistance and outreach and is seeking
additional comment in this proposal. However, comments already
submitted need not be resubmitted. Please refer to the discussion in
Section XV. Specifically, OSHA is interested in your responses to the
following: What types of materials or products would best assist
employers in understanding and complying with the modified HCS? OSHA
seeks input to identify the tools that would be most useful to
employers and employees, the subjects of greatest interest (e.g.,
classification criteria, labels, safety data sheets), and the best
means of distributing these materials.
29. OSHA received a number of comments that suggested that a data
base of chemical classifications should be developed and maintained to
assist chemical manufacturers and importers in performing hazard
classifications. This approach has been adopted in some other
countries. Would such a data base be helpful? Who would be responsible
for doing the classifications and maintaining them? How would the data
base be kept aligned with other countries' classifications?
Alternative Approaches
30. OSHA has described alternatives to the scope and application of
the proposed rule in the preamble, Section IV. These include
consideration of allowing voluntary implementation of the GHS;
exemptions based on size of the business; adopting some components of
the GHS but not others; and not adopting all of the required label
elements. The Agency requests comments on these alternatives, with data
to support the views expressed. Suggestions and support for other
alternatives are requested as well.
III. Events Leading to the Proposed Modifications to the Hazard
Communication Standard
OSHA's Hazard Communication Standard (HCS) (29 CFR 1910.1200;
1915.1200; 1917.28; 1918.90; and 1926.59) was first issued in 1983 and
covered the manufacturing sector of industry (48 FR 53280, November 25,
1983). In 1987, the Agency expanded the scope of coverage to all
industries where employees are potentially exposed to hazardous
chemicals (52 FR 31852, August 24, 1987). Although full implementation
in the non-manufacturing sector was delayed by various court and
administrative actions, the rule has been fully enforced in all
industries covered by OSHA since March 17, 1989 (54 FR 6886, February
15, 1989). In 1994, OSHA made a number of minor changes and technical
amendments to the HCS to help ensure full compliance and achieve better
protection of employees (59 FR 6126, February 9, 1994). The development
of the HCS is discussed in detail in the preambles to the original and
revised final rules (see 48 FR 53280-53281; 52 FR 31852-31854; and 59
FR 6127-6131). This discussion will focus on the sequence of events
leading to the development of the Globally Harmonized System of
Classification and Labelling of Chemicals (GHS) and the modifications
to the HCS included in this proposed rule.
The HCS requires chemical manufacturers and importers to evaluate
the chemicals they produce or import to determine if they are
hazardous. The rule provides definitions of health and physical hazards
to use as the criteria for determining hazards in the evaluation
process. Information about hazards and protective measures is then
required to be conveyed to downstream employers and employees through
labels on containers and safety data sheets. All employers with
hazardous chemicals in their workplaces are required to have a hazard
communication program, including container labels, safety data sheets,
and employee training. (Note: The HCS uses the term ``material safety
data sheet'' or ``MSDS'', while the GHS uses ``safety data sheet'' or
``SDS''. For convenience and for consistency with the GHS, safety data
sheet or SDS is being used throughout this document and that term would
replace MSDS in the modified HCS.)
To protect employees and members of the public who are potentially
exposed to chemicals during their production,
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transportation, use, and disposal, a number of countries have developed
laws that require information about those chemicals to be prepared and
transmitted to affected parties. These laws vary with regard to the
scope of chemicals covered, definitions of hazards, the specificity of
requirements (e.g., specification of a format for safety data sheets),
and the use of symbols and pictograms. The inconsistencies between the
various laws are substantial enough that different labels and safety
data sheets must often be developed for the same product when it is
marketed in different nations.
Within the U.S., several regulatory authorities exercise
jurisdiction over chemical hazard communication. In addition to OSHA's
HCS, the Department of Transportation (DOT) regulates chemicals in
transport, the Consumer Product Safety Commission (CPSC) regulates
consumer products, and the Environmental Protection Agency (EPA)
regulates pesticides, as well as having other authority over labeling
under the Toxic Substances Control Act. Each of these regulatory
authorities operates under different statutory mandates, and has
adopted distinct hazard communication requirements.
Tracking the hazard communication requirements of different
regulatory authorities is a burden for manufacturers, importers,
distributors, and transporters engaged in commerce in the domestic
arena. This burden is magnified by the need to develop multiple sets of
labels and safety data sheets for each product in international trade.
Small businesses may have particular difficulty in coping with the
complexities and costs involved. The problems associated with differing
national and international requirements were recognized and discussed
when the HCS was first issued in 1983. The preamble to the final rule
included a commitment by OSHA to review the standard regularly to
address international harmonization of hazard communication
requirements. OSHA was asked to include this commitment in recognition
of an interagency trade policy that supported the U.S. pursuing
international harmonization of requirements for chemical classification
and labeling. The potential benefits of harmonization were noted in the
preamble:
* * * [O]SHA acknowledges the long-term benefit of maximum
recognition of hazard warnings, especially in the case of containers
leaving the workplace which go into interstate and international
commerce. The development of internationally agreed standards would
make possible the broadest recognition of the identified hazards
while avoiding the creation of technical barriers to trade and
reducing the costs of dissemination of hazard information by
elimination of duplicative requirements which could otherwise apply
to a chemical in commerce. As noted previously, these regulations
will be reviewed on a regular basis with regard to similar
requirements which may be evolving in the United States and in
foreign countries. (48 FR 53287)
OSHA has actively participated in a number of such efforts in the
years since that commitment was made, including trade-related
discussions on the need for harmonization with major U.S. trading
partners. The Agency also issued a Request for Information (RFI) in the
Federal Register in January 1990 to obtain input regarding
international harmonization efforts, and on work being done at that
time by the International Labor Organization (ILO) to develop a
convention and recommendations on safety in the use of chemicals at
work (55 FR 2166, January 22, 1990). On a closely related matter, OSHA
published an RFI in May 1990 requesting comments and information on
improving the effectiveness of information transmitted under the HCS
(55 FR 20580, May 17, 1990). Possible development of a standardized
format or order of information was raised as an issue in the RFI.
Nearly 600 comments were received in response to this request. The
majority of responses expressed support for a standard SDS format, and
the majority of responses that expressed an opinion on the topic
favored a standardized format for labels as well.
In June 1992, the United Nations Conference on Environment and
Development issued a mandate (Chapter 19 of Agenda 21), supported by
the U.S., calling for development of a globally harmonized chemical
classification and labeling system:
A globally harmonized hazard classification and compatible
labelling system, including material safety data sheets and easily
understandable symbols, should be available, if feasible, by the
year 2000.
This international mandate initiated a substantial effort to develop
the GHS, involving numerous international organizations, many
countries, and extensive stakeholder representation.
A coordinating group comprised of countries, stakeholder
representatives, and international organizations was established to
manage the work. This group, the Inter-Organization Programme for the
Sound Management of Chemicals Coordinating Group for the Harmonization
of Chemical Classification Systems, established overall policy for the
work and assigned tasks to other organizations to complete. The
Coordinating Group then took the work of these organizations and
integrated it to form the GHS. OSHA served as chair of the Coordinating
Group.
The work was divided into three main parts: Classification criteria
for physical hazards; classification criteria for health and
environmental hazards (including criteria for mixtures); and hazard
communication elements, including requirements for labels and safety
data sheets. The criteria for physical hazards were developed by a
United Nations Subcommittee of Experts on the Transport of Dangerous
Goods/International Labour Organization working group and were based on
the already harmonized criteria for the transport sector. The criteria
for classification of health and environmental hazards were developed
under the auspices of the Organization for Economic Cooperation and
Development. The ILO developed the hazard communication elements. OSHA
participated in all of this work, and served as U.S. lead on
classification of mixtures and hazard communication.
Four major existing systems served as the primary basis for
development of the GHS. These systems were the requirements in the U.S.
for the workplace, consumers and pesticides; the requirements of Canada
for the workplace, consumers and pesticides; European Union directives
for classification and labeling of substances and preparations; and the
United Nations Recommendations on the Transport of Dangerous Goods. The
requirements of other systems were also examined as appropriate, and
taken into account as the GHS was developed. The primary approach to
reconciling these systems involved identifying the relevant provisions
in each system; developing background documents that compared,
contrasted, and explained the rationale for the provisions; and
undertaking negotiations to find an agreed approach that addressed the
needs of the countries and stakeholders involved. Principles to guide
the work were established, including an agreement that protections of
the existing systems would not be reduced as a result of harmonization.
Thus countries could be assured that the existing protections of their
systems would be maintained or enhanced in the GHS.
An interagency committee under the auspices of the Department of
State coordinated U.S. involvement in the development of the GHS. In
addition to OSHA, DOT, CPSC, and EPA, there were a number of other
agencies
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involved that had interests related to trade or other aspects of the
GHS process. Different agencies took the lead in various parts of the
discussions. Positions for the U.S. in these negotiations were
coordinated through the interagency committee. Interested stakeholders
were kept informed through e-mail dissemination of information, as well
as periodic public meetings. In addition, the Department of State
published a notice in the Federal Register that described the
harmonization activities, the agencies involved, the principles of
harmonization, and other information, as well as invited public comment
on these issues (62 FR 15951, April 3, 1997). Stakeholders also
actively participated in the discussions at the international level and
were able to present their views directly in the negotiating process.
The GHS was formally adopted by the new United Nations Committee of
Experts on the Transport of Dangerous Goods and the Globally Harmonized
System of Classification and Labelling of Chemicals in December 2002.
In 2003, the adoption was endorsed by the Economic and Social Council
of the United Nations. The GHS will be updated as necessary to reflect
new technology and scientific developments, or provide additional
explanatory text. This proposed rule is based on Revision 3 of the GHS,
published in 2009.
Countries have been encouraged to implement the GHS as soon as
possible, and established a goal to have fully operational systems by
2008. This goal was adopted by countries in the Intergovernmental Forum
on Chemical Safety, and was endorsed by the World Summit on Sustainable
Development. The U.S. participated in these groups, and agreed to work
toward achieving these goals. While much progress was made by the U.S.
and other countries by the end of 2008, most are still in the process
of implementing the GHS.
OSHA published an Advance Notice of Proposed Rulemaking (ANPR) on
the GHS in September of 2006 (71 FR 53617, September 12, 2006). The
ANPR provided information about the GHS and its potential impact on the
HCS, and sought input from the public on issues related to GHS
implementation. Over 100 responses were received, and the comments and
information provided were taken into account in the development of the
modifications to the HCS included in this proposed rule. At the same
time the ANPR was published, OSHA made a document summarizing the GHS
available on its Web site (https://www.osha.gov).
OSHA remains engaged in a number of activities related to the GHS.
The U.S. is a member of both the United Nations Committee of Experts on
the Transport of Dangerous Goods and the Globally Harmonized System of
Classification and Labeling of Chemicals, as well as the Subcommittee
of Experts on the Globally Harmonized System of Classification and
Labeling of Chemicals. These permanent UN bodies have international
responsibility for maintaining, updating as necessary, and overseeing
the implementation of the GHS. OSHA and other affected Federal agencies
actively participate in these UN groups. In addition, OSHA and EPA also
participate in the GHS Programme Advisory Group under the United
Nations Institute for Training and Research (UNITAR). UNITAR is
responsible for helping countries implement the GHS, and has ongoing
programs to prepare guidance documents, conduct regional workshops, and
implement pilot projects in a number of nations. OSHA also continues to
be involved in interagency discussions related to coordination of
domestic implementation of the GHS, and in discussions related to
international work to implement and maintain the GHS.
IV. Overview and Purpose of the Proposed Modifications to the Hazard
Communication Standard
The intent of the HCS is to ensure that the hazards of all
chemicals are evaluated, and that information concerning chemical
hazards and associated protective measures is transmitted to employers
and employees. The standard achieves this goal by requiring chemical
manufacturers and importers to review available scientific evidence
concerning the physical and health hazards of the chemicals they
produce or import to determine if they are hazardous. For every
chemical found to be hazardous, the chemical manufacturer or importer
must develop a container label and an SDS and provide both documents to
downstream users of the chemical. All employers with employees exposed
to hazardous chemicals must develop a hazard communication program, and
ensure that exposed employees are provided with labels, access to SDSs,
and training on the hazardous chemicals in their workplace.
The three information components in this system--labels, SDSs, and
employee training--are all essential to the effective functioning of
the program. Labels provide a brief, but immediate and conspicuous
summary of hazard information at the site where the chemical is used.
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. Training is designed to ensure that employees
understand the chemical hazards in their workplace and are aware of
protective measures to follow. Labels, SDSs, and training are
complementary parts of a comprehensive hazard communication program--
each element reinforces the knowledge necessary for effective
protection of employees.
Information required by the HCS reduces the incidence of chemical-
related illnesses and injuries by enabling employers and employees to
implement protective measures in the workplace. Employers can select
less hazardous chemical alternatives and ensure that appropriate
engineering controls, work practices, and personal protective equipment
are in place. Improved understanding of chemical hazards by supervisory
personnel results in safer handling of hazardous substances, as well as
proper storage and housekeeping measures.
Employees provided with information and training on chemical
hazards are able to fully participate in the protective measures
instituted in their workplaces. Knowledgeable employees can take the
steps required to work safely with chemicals, and are able to determine
what actions are necessary if an emergency occurs. Information on
chronic effects of exposure to hazardous chemicals helps employees
recognize signs and symptoms of chronic disease and seek early
treatment. Information provided under the HCS also enables health and
safety professionals to provide better services to exposed employees.
Medical surveillance, exposure monitoring, and other services are
enhanced by the ready availability of health and safety information.
OSHA believes that the comprehensive approach adopted in the HCS--
requiring evaluation of chemicals and the transmittal of information
through labels, SDSs, and training--is sound. The proposed
modifications to the rule do not alter that approach. Rather, the
proposed modifications to the rule are intended to improve the
effectiveness of the HCS by enhancing the quality and consistency of
the information provided to employers and employees. OSHA believes this
can be accomplished by modifying the requirements of the standard to
conform with the more specific and detailed provisions of the GHS for
classification,
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labeling, and SDSs. OSHA's rationale for this belief is summarized
below. The evidence supporting this preliminary conclusion is presented
in Section V of this preamble, and the proposed revisions to the HCS
are discussed in detail in Section XV.
HCS Provisions for Classification, Labeling, and SDSs
The HCS covers a broad range of health and physical hazards. The
standard is performance-oriented, providing definitions of hazards and
parameters for evaluating the evidence to determine whether a chemical
is considered hazardous. The evaluation is based upon evidence that is
currently available, and no testing of chemicals is required.
The standard covers every type of health effect that may occur,
including both acute and chronic effects. Definitions of a number of
adverse health effects are provided in the standard. These definitions
are indicative of the wide range of coverage, but are not exclusive.
Any adverse health effect that is substantiated by a study conducted
according to established scientific principles, and reporting a
statistically significant outcome, is sufficient for determining that a
chemical is hazardous under the rule.
Most chemicals in commerce are not present in the pure state (i.e.,
as individual elements or compounds), but are provided as mixtures of
chemicals. Evaluation of the health hazards of mixtures is based on
data for the mixture as a whole when such data are available. When data
on the mixture as a whole are not available, the mixture is considered
to present the same health hazards as any ingredients present at a
concentration of 1% or greater, or, in the case of carcinogens,
concentrations of 0.1% or greater. The HCS also recognizes that risk
may remain at concentrations below these cut-offs, and where there is
evidence that is the case, the mixtures are considered hazardous under
the standard.
The current definitions of physical hazards in the HCS were derived
from other OSHA standards that address such chemicals (e.g., flammable
chemicals), or from the DOT criteria for physical hazards at the time
OSHA promulgated the HCS. DOT subsequently changed their criteria to be
consistent with the internationally harmonized transport requirements,
and the HCS criteria for classification of physical hazards are
generally not consistent with current DOT requirements.
The HCS establishes requirements for minimum information that must
be included on labels and SDSs, but does not provide specific language
to convey the information or a format in which to provide it. When the
HCS was issued in 1983, the public record strongly supported this
performance-oriented approach (see 48 FR 53300-53310). Many chemical
manufacturers and importers were already providing information
voluntarily, and in the absence of specific requirements had developed
their own formats and approaches. The record indicated that a
performance-oriented approach would reduce the need for chemical
manufacturers and importers to revise these existing documents to
comply with the HCS, thus reducing the cost impact of the standard. In
recognition of the work that had been voluntarily completed, OSHA
decided to allow labels and SDSs to be presented in any format desired,
as long as the minimum information requirements of the standard were
met.
GHS Provisions for Classification, Labeling, and SDSs
The GHS is an internationally harmonized system for classifying
chemical hazards and developing labels and safety data sheets. However,
the GHS is not a model standard that can be adopted verbatim. Rather,
it is a set of criteria and provisions that regulatory authorities can
incorporate into existing systems, or use to develop a new system.
The GHS is designed to allow regulatory authorities to choose
provisions that are appropriate to their particular sphere of
regulation. This is referred to as the ``building block approach.'' The
GHS includes all of the regulatory components, or building blocks, that
might be needed for classification and labeling requirements for
chemicals in the workplace, transport, pesticides, and consumer
products.
Regulatory authorities such as OSHA adopt the provisions of the GHS
that are appropriate for their particular regulatory sector, but do not
need to adopt all of the criteria and provisions of the GHS. For
example, the GHS includes criteria for classifying chemicals for
aquatic toxicity. Since OSHA does not have the regulatory authority to
address environmental concerns, OSHA would not adopt the GHS criteria
for aquatic toxicity. The building block approach may also be applied
to the criteria for defining hazards. For example, the acute toxicity
criteria in the GHS are much broader than those currently found in the
HCS. This is to allow consumer product authorities the ability to
address the protection of children and other vulnerable populations.
OSHA would not need to adopt all of the acute toxicity categories to
maintain protection of employees in the workplace.
The building block approach can also be applied when a regulatory
authority decides which parts of the system to adopt. For example, the
GHS includes classification criteria and provisions for labels and
SDSs. While OSHA is proposing to adopt all of these elements because
the current HCS cover labels and SDSs, consumer product and
transportation authorities are not expected to require SDSs.
Under the GHS, each hazard or endpoint (e.g., Explosives,
Carcinogenicity) is considered to be a hazard class. The classes are
generally sub-divided into categories of hazard. The definitions of
hazards are more specific and detailed than those currently in the HCS.
For example, under the HCS, a chemical is either an explosive or it is
not. Under the GHS, there are seven categories of explosives, and
assignment to these categories is based on the classification criteria
provided.
The GHS generally applies a tiered approach to evaluation of
mixtures. The first step is consideration of data on the mixture as a
whole. The second step allows the use of ``bridging principles'' to
estimate the hazards of the mixture based on information about its
components. The third step of the tiered approach involves use of cut-
off values based on the composition of the mixture, or for acute
toxicity, a formula which is used for classification. The approach is
generally consistent with the current requirements of the HCS, but
provides more detail and specification and allows for extrapolation of
data available on the components of a mixture to a greater extent--
particularly for acute effects.
Hazard communication requirements under the GHS are directly linked
to the hazard classification. For each class and category of hazard, a
harmonized signal word (e.g., Danger), pictogram (e.g., skull and
crossbones), and hazard statement (e.g., Fatal if Swallowed) are
specified. These specified elements are referred to as the core
information for a chemical. Thus, once a chemical is classified, the
GHS provides the specific core information to convey to users of that
chemical. The core information allocated to each category generally
reflects the degree of severity of the hazard. Precautionary statements
are also required on GHS labels. The GHS provides example precautionary
statements, but they are not yet
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considered formally harmonized. In other words, it would be possible
for regulatory authorities to use different language for the
precautionary statements. However, it appears likely that the language
in the examples will become the harmonized text of the GHS on
precautionary statements in the near future. The most recent revision
to the GHS has codified these statements (i.e., assigned numbers to
them) as well as aligned them with the hazard classes and categories.
Codification allows reference to them in a shorthand form, and makes it
easier for authorities using them in regulatory text to organize them.
In addition, there are provisions to allow supplementary information so
that chemical manufacturers can provide data in addition to the
specified core information.
The GHS establishes a standardized 16-section format for SDSs to
provide a consistent sequence for presentation of information to SDS
users. Items of primary interest to exposed employees and emergency
responders are presented at the beginning of the document, while more
technical information is presented later. Headings for the sections
(e.g., First Aid Measures, Handling and Storage) are standardized to
facilitate locating information of interest. The harmonized data sheets
are consistent with the order of information included in the voluntary
industry consensus standard for safety data sheets (ANSI Z400.1).
Advantages of the Proposed Modifications to the Standard
OSHA believes that the detailed and specific classification
requirements of the GHS would result in better, more consistent
information being provided to employers and employees. Classification
under the revised criteria would not only indicate the type of hazard,
but would generally give an indication of the degree of severity of the
hazard as well. This information would be helpful to both employers and
employees in understanding chemical hazards and identifying and
implementing protective measures. The detailed criteria for
classification are also expected to result in greater accuracy in
hazard classification and more consistency among classifiers. By
following the detailed criteria, classifiers are less likely to reach
different interpretations of the same data.
OSHA also believes that standardized presentation of information on
labels and safety data sheets would improve the comprehensibility of
chemical hazard information. Employers and employees would be given the
same core information on a chemical regardless of the supplier. Use of
standardized pictograms would complement and reinforce the information
provided through signal words and hazard statements. Pictograms are
also anticipated to improve communication for those who are not
functionally literate, or who are not literate in the language used on
the label. The standardized format for SDSs is expected to make the
information easier for users to find, with the information employees
and emergency responders need most appearing in the beginning of the
document for easy identification and reference.
Standardized requirements for labels and SDSs are also expected to
increase the accuracy of chemical hazard information. With consistent
presentation of information, the task of reviewing SDSs and labels to
assure accuracy would be simplified. Individuals preparing and
reviewing these documents should find it easier to identify any missing
elements, and OSHA enforcement personnel should be able to more
efficiently examine SDSs and labels when conducting inspections.
Another advantage that will result from adopting a system that has
harmonized hazard statements in it relates to the use of ``control
banding,'' a guidance approach to recommending control measures for
chemical exposures. The approach uses information that is readily
available to small and medium-sized employers with chemicals in their
workplaces to provide them with workplace-specific control
recommendations. Basically, the system uses such information to
estimate the degree of severity of the hazard and the amount of
chemical present, and relates that to the degree of control needed. The
control banding approach relies on harmonized hazard statements to
allow the system to estimate the degree of severity of the hazard.
Initially based on the European hazard classification system, it has
now been converted to the GHS phrases. The use of control banding to
provide guidance for chemical safety and health approaches in U.S.
workplaces cannot be accomplished until harmonized hazard statements
are readily available. Adoption of the GHS and its phrases would open
up the possibility that control banding guidance can be used in the
U.S. to help small and medium-sized employers select and implement
appropriate control measures. For more information on control banding,
please see https://www.cdc.gov/niosh/topics/ctrlbanding/.
OSHA is proposing modifications to the HCS that are necessary for
consistency with the GHS. The GHS does not include requirements for a
written hazard communication program or for employee training. OSHA is
not proposing any substantive changes to the requirements for a written
hazard communication program. However, OSHA believes that additional
training would be necessary to ensure that employees understand some
elements of the new system. In particular, s