[Federal Register: September 30, 2009 (Volume 74, Number 188)][Proposed Rules]
[Page 50279-50549]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30se09-14]
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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
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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.
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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 http://
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 http://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
http://www.regulations.gov or to the OSHA Docket Office at the address
above. All comments are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through that 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 http://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 http://
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
(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 http://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
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?
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.
• 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.
• 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
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-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, 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 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 (http://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, 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 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 http://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, 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
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.
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 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
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 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 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 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.
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 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 non-technical 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).
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 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
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.
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
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 low-literate 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
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 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 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.
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 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 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 non-intuitive (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 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."
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 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 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, 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 non-verbal 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 performance-
oriented 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 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 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 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:
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 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, 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 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, 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-to-Know 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, 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 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 16-section 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
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 fire-related 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 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 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
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 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 sub-headings 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/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
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 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 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 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 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 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 Sec.
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.
OSH Act Sec. 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
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 Sec. 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 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 Sec. 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 Sec. 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 Sec. 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,
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 NIOSH-identified chemical hazards and
that for the years 1977 and 1978, more than 174,000 illnesses were
likely caused by exposure to hazardous chemicals. 48 FR 53282. 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 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 Sec. 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 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. 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 x-rays were not higher than annual
exams. 63 FR 33458-59. In addition, OSHA has 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 Sec. 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
on-going relationship with NIOSH are more 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. Sec. 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 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 http://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 GHS-modified HCS will not be more expensive than compliance
with the current HCS. (Document ID s 0046, 0047, 0080, 0103,
0104, 0105, 0179, 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
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.
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 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 Cost-Effectiveness
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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, 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 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 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
http://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 cost-
effectiveness. However, it should be noted that the estimated benefits
exceed costs by a factor of eight.
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TP30SE09.000
BILLING CODE 4510-26-C
Compliance Costs
The estimated compliance costs for the proposed revisions to the
HCS represent the additional costs necessary for employers to achieve
full compliance. They do not include costs associated with current
compliance that 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 management-related costs as may be necessary ($42 million).
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.
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.
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 Cost-Effectiveness;
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 worker-protective and more efficient and effective. In
addition, the improvements would have the effect of harmonizing
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\
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\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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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 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\
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\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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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 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
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.
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 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 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.
BILLING CODE 4510-26-P
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BILLING CODE 4510-26-C
OSHA requests comments from the public regarding these preliminary
conclusions and requests information on the number and type of labels
and 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 Cost-Effectiveness
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 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 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 non-lost-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\
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\5\ http://data.bls.gov/cgi-bin/cpicalc.pl. BLS inflation
calculator used on September 23, 2008.
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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\
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\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 chemically-related, 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 related-fatalities 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 twenty-year period beginning with the effective date of
the final rule.\8\ Thus, the annualized monetized benefit associated
with the reduction in safety and health risks attributable to the
proposed revisions is an estimated $266 million.
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\8\ The formula for annualizing the benefits is equal to:
[(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 20-year period.
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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 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 non-manufacturing sectors.
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\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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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 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\
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\11\ These estimates assume \1/3\ of the estimated 880,260 SDSs
are reviewed each year; savings per SDS is between 2\1/2\ 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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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 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
cost-effectiveness 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 cost-effectiveness 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\
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\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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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
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.
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 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
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
corresponding benefits estimates, the expected timing of these costs
was taken 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 (non-discounted)
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, 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 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 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. 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 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 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).
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\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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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\
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\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 x 25% not in existing compliance x 95% requiring
modification) + (128,000 SDSs for establishments with 100-500
employees x 75% not in existing compliance x 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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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 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).
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 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 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\
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\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 x $1000 per manager) plus $16.4 million for
logistics personnel in manufacturing (43,600 affected logistics
persons x 8 hours x $47 per hour) plus $116 million for health and
safety supervisors in manufacturing (309,000 affected health and
safety supervisors in manufacturing x 8 hours x $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 x 2 hours x $47 per hour).
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.
---------------------------------------------------------------------------
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 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\
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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 x 0.42 hours x $26 per
hour) plus $75 million in management hours to provide the training
(3.8 million managers x 0.42 hours x $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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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.
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.
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 Non-annualized Costs of Compliance
Table VII-4 shows the total non-annualized (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 non-annualized 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.
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G. Economic Feasibility and Impacts
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 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 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 absorbed through a combination of increases in prices or
reduction in profits. The extent to which the impacts of cost increases
affect prices or profits depends on the price elasticity of demand for the
products or services produced and sold by the entity.
The price elasticity of demand refers to the relationship between
changes in the price charged for a product and the resulting changes in
the demand for that product. A 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 cost-effective 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
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;
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
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 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 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-year transition period are estimated to be $740 million, or
about $247 million 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 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, http://www.kemi.se/templates/Page____4268.aspx,
2007 data.)
OSHA conducted a similar analysis for very small firms with fewer
than 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 that would incur significant economic 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 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
(non-tariff) 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 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 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. 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 chemical-related 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 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.
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 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
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 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 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.
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 performance-oriented 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,
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 non-quantified 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 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 one-time 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 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 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 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 phase-in, 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.
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 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 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.
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 number of affected SDSs addressed by this rulemaking by 50
percent, the 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\
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\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.
---------------------------------------------------------------------------
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.
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.
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
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:
• Whether the proposed collection of information requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and cost)
of the information collection requirements, including the validity of
the methodology and assumptions used;
• The quality, utility, and clarity of the information
collected; and
• 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. 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 Sec. 1910.1200 shall be consulted for classification of health
hazards, and Mandatory Appendix B to Sec. 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 Sec. 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 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.
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.
General Industry
------------------------------------------------------------------------
------------------------------------------------------------------------
Asbestos 1910.1001......................................... 1218-0133
13 Carcinogens 1910.1003................................... 1218-0085
Vinyl Chloride 1910.1017................................... 1218-0010
Inorganic Arsenic 1910.1018................................ 1218-0104
Lead 1910.1025............................................. 1218-0092
Chromium (VI) 1910.1026.................................... 1218-0252
Cadmium 1910.1027.......................................... 1218-0185
Benzene 1910.1028.......................................... 1218-0129
Coke Oven Emissions 1910.1029.............................. 1218-0128
Cotton Dust 1910.1043...................................... 1218-0061
1,2-dibromo-3-chloropropane 1910.1044...................... 1218-0101
Acrylonitrile 1910.1045.................................... 1218-0126
Ethylene Oxide 1910.1047................................... 1218-0108
Formaldehyde 1910.1048..................................... 1218-0145
Methylenedianiline 1910.1050............................... 1218-0184
1,3-Butadiene 1910.1051.................................... 1218-0170
Methylene Chloride 1910.1052............................... 1218-0179
Hazard Communication 1910.1200............................. 1218-0072
------------------------------------------------------------------------
Construction Industry...................................................
------------------------------------------------------------------------
Methylenedianiline 1926.60................................. 1218-0183
Lead 1926.62............................................... 1218-0189
Asbestos 1926.1101......................................... 1218-0134
Chromium 1926.1126......................................... 1218-0252
Cadmiun 1926.1127.......................................... 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
Sec. 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 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 for-profit.
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 http://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
http://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 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 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 state-
plan 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 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
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.
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.
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):
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 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):
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 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 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 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:
* * *[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 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):
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, 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 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-the-
trainer 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, 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 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 Federally-approved 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 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 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 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.
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 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 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 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
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
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); self-reactive;
pyrophoric (liquid or solid); self-heating; organic peroxide; corrosive
to metal; gas under pressure; or water-activated 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.
"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 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 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
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 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). 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[reg] 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 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 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 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:
* * * [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 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 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 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
across-the-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 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 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
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 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 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 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.
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 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 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 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. 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 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, 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 in-plant
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 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) 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 in-plant 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 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 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.
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 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
(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
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 performance-
oriented 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 communication
is expected to increase as a result. OSHA believes these long-term 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 IDs 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 water-reactive 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 (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 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
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 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 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 phase-in 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
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:
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 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 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 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 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 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 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, 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, 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 substance-specific 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 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
OSHA proposes to update substance-specific 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 Sec. 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.
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 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 are covered by HCS. The new paragraph that will
reference the modified HCS in each substance specific standard states:
( ) 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 accordance with the provisions
of HCS and paragraph () of this section. The employer shall provide
information on at least the following hazards: (insert hazards)
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 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 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 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
statements that address creating dust in the substance-specific health
standards 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 substance-specific 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 Sec. 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.
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." (Sec. 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 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 Sec. 1910.252 requirements on
labeling 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 Sec.
1910.106 \35\; but
---------------------------------------------------------------------------
\35\ In Sec. 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.
---------------------------------------------------------------------------
Leave unchanged electrical standards in Subpart S for
general industry and Subpart K for construction, and explosive
standards Sec. 1910.109 for general industry and Sec. 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) * * *
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.
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 °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 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 Sec. 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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OSHA is also proposing to adopt the terminology in the GHS
modifications to HCS so that all liquids covered by Sec. 1910.106 will
be redefined as flammable liquids in Categories 1-4, as appropriate,
and the term "Combustible Liquids" in Sec. Sec. 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 Sec. 1910.107, Spray Finishing Using Flammable and
Combustible Materials, relying on the current Sec. 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.
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 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:
"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.
Sec. 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. Sec.
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 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 Sec. 1910.109 is currently in
progress.
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XVII. Authority and Signature
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 amend 29 CFR parts 1910, 1915 and
1926 as set forth below:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS [AMENDED]
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 Sec. 1910.6 by adding new paragraphs (h)(22) through
(h)(28), (q)(36), (x), and (y) to read as follows:
Sec. 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 Sec. 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 Sec. 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 Sec.
1910.1200,.
(25) ASTM D 93-96, Standard Test Methods for Flash Point by Pensky-
Martens Closed Cup Tester, IBR approved for Appendix B to Sec.
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 Sec. 1910.1200.
(27) ASTM D 86-07a Standard Test Method for Distillation of
Petroleum Products at Atmospheric Pressure, IBR approved for Appendix B
to Sec. 1910.1200.
(28) ASTM D 1078-05 Standard Test Method for Distillation Range of
Volatile Organic Liquids, IBR approved for Appendix B to Sec.
1910.1200.
* * * * *
(q) * * *
(36) NFPA 30B-2006 Code for the Manufacture and Storage of Aerosol
Products, IBR approved for Appendix B to Sec. 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 Sec. 1910.1200.
(2) EN/ISO 13943-2000, 86.1 to 86.3--Fire Safety--Vocabulary, IBR
approved for Appendix B to Sec. 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 Sec. 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 Sec. 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 Sec.
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 Sec. 1910.1200, (see
B.11).
(2) [Reserved]
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 Sec. 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:
Sec. 1910.106 Flammable liquids.
* * * * *
(a) * * *
(13) Flammable aerosol shall mean a flammable aerosol as defined by
Appendix B to Sec. 1910.1200--Physical Hazard Criteria. For the
purposes of 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
[ordm]F (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 Sec. 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 Sec.
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 Sec. 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 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 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 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
* * * * *
(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 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 vapor-air 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) * * *
(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 vapor-air 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 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 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 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 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 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 automatic-closing 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) * * *
* * * * *
(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
°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 vapor-air 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 vapor-air 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........ 1 pt.............. 1 qt.............. 1 gal............. 1 gal.
Metal (other than DOT drums)..... 1 gal............. 5 gal............. 5 gal............. 5 gal.
Safety cans...................... 2 gal............. 5 gal............. 5 gal............. 5 gal.
Metal drums (DOT specifications). 60 gal............ 60 gal............ 60 gal............ 60 gal.
Approved portable tanks.......... 660 gal........... 660 gal........... 660 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).
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TP30SE09.055
[GRAPHIC] [TIFF OMITTED] TP30SE09.056
[GRAPHIC] [TIFF OMITTED] TP30SE09.057
[GRAPHIC] [TIFF OMITTED] TP30SE09.058
[GRAPHIC] [TIFF OMITTED] TP30SE09.059
[GRAPHIC] [TIFF OMITTED] TP30SE09.060
BILLING CODE 4510-26-C
* * * * *
5. Amend Sec. 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:
Sec. 1910.107 Spray finishing using flammable and combustible
materials.
* * * * *
(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 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 Sec. 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:
Sec. 1910.119 Process safety management of highly hazardous
chemicals.
* * * * *
(a) * * *
(1) * * *
(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 Sec. 1910.1200--Definition of a Trade Secret (which sets
out the criteria to be used in evaluating trade secrets).
* * * * *
7. In Sec. 1910.120, revise the definition of the term Health
hazard in paragraph (a)(3) to read as follows:
Sec. 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 Sec. 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 Sec. 1910.123, by removing the term
"Combustible liquid" and revising the definitions of the terms
"Flammable liquid" and "Flashpoint" to read as follows:
Sec. 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 Sec. 1910.1200--
Physical Hazard Criteria.
* * * * *
9. In Sec. 1910.124, revise paragraph (c)(2) introductory text to
read as follows:
Sec. 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:
* * * * *
10. Amend Sec. 1910.125 introductory text (including the table) to
read as follows:
Sec. 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 Sec. Sec. 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 The liquid is heated as part
°F (93 °C) or above. 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 Sec. 1910.252 as follows;
A. Revise paragraph (c)(1)(iv);
B. Add new paragraph (c)(1)(v).
Sec. 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 Sec.
1910.1200, if any, associated with the use of their 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 Sec. 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).
D. Add new paragraph (j)(1);
The revisions, with new designations, read as follows:
Sec. 1910.1001 Asbestos.
* * * * *
(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:
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:
WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING IN THIS AREA
(iii) The employer shall ensure that employees working in and
contiguous to 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
CONTAINS ASBESTOS FIBERS
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
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 Sec. 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. Remove paragraph (e)(3);
E. Redesignate paragraphs (e)(4) and (e)(5) as (e)(3) and (e)(4).
The revisions read as follows:
Sec. 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:
DANGER
(CHEMICAL IDENTIFICATION)
MAY CAUSE CANCER
WEAR AIR SUPPLIED HOODS, IMPERVIOUS SUITS, AND PROTECTIVE EQUIPMENT IN
THIS AREA
AUTHORIZED PERSONNEL ONLY
(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 Sec. 1910.1017 by revising paragraph (l) to read as
follows:
Sec. 1910.1017 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
MAY CAUSE CANCER
WEAR RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING IN THIS 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 legible and include the following
information:
CONTAMINATED WITH VINYL CHLORIDE
MAY CAUSE CANCER
(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 Sec. 1910.1018 by revising paragraphs (j)(2)(vii) and
(p) as follows:
Sec. 1910.1018 Inorganic arsenic.
* * * * *
(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:
DANGER
INORGANIC ARSENIC
MAY CAUSE CANCER
DO NOT EAT, DRINK OR SMOKE
WEAR RESPIRATORY PROTECTION IN THIS AREA
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 Sec. 1910.1025 to revise paragraph (g)(2)(vii) and
paragraph (m) to read as follows:
Sec. 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 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 Sec. 1910.1026 to revise paragraphs (h)(2)(iv),
(j)(3)(ii) and (l)(1) to read as follows:
Sec. 1910.1026 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 Sec. 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:
Sec. 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, 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:
DANGER
CONTAINS CADMIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS AND KIDNEYS
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:
DANGER
CADMIUM
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:
DANGER
CONTAINS CADMIUM
MAY CAUSE CANCER
* * * * *
21. Amend Sec. 1910.1028 to revise the heading of paragraph (j)
and the regulatory text of paragraphs (j)(1) and (j)(2) to read as
follows:
Sec. 1910.1028 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
* * * * *
22. Amend Sec. 1910.1029 to revise paragraph (l) to read as
follows:
Sec. 1910.1029 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.
(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 Sec. 1910.1043 to revise paragraph (j) as follows:
Sec. 1910.1043 Cotton dust.
* * * * *
(j) Signs. The employer shall post the following warning sign in
each work area where the permissible exposure limit for cotton dust is
exceeded:
DANGER
COTTON DUST
CAUSES DAMAGE TO LUNGS
(BYSSINOSIS)
WEAR RESPIRATORY PROTECTION IN THIS AREA
* * * * *
24. Amend Sec. 1910.1044 to revise paragraphs (j)(2)(v),
(k)(1)(iii)(b), and (o) to read as follows:
Sec. 1910.1044 1,2-dibromo-3-chloropropane.
* * * * *
(j) * * *
(2) * * *
(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-
Dibromo-3-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
1,2-Dibromo-3-chloropropane
MAY CAUSE CANCER
WEAR RESPIRATORY PROTECTION IN THIS AREA
AUTHORIZED PERSONNEL ONLY
(3) The employer shall ensure that the precautionary labels
required by this paragraph are readily visible and legible.
* * * * *
25. Amend Sec. 1910.1045 to revise paragraphs (p)(1)(i),
(p)(2)(i), and (p)(3) to read as follows:
Sec. 1910.1045 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 AN-based 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 Sec. 1910.1047 to revise the heading of paragraph (j)
and paragraphs (j)(1) and (j)(2) to read as follows:
Sec. 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.
(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:
DANGER
ETHYLENE OXIDE
MAY CAUSE CANCER
MAY DAMAGE FERTILITY OR THE UNBORN CHILD
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 Sec. 1910.1048 to revise paragraphs (e)(1); (h)(2)(ii);
(j)(4) and (m) to read as follows:
Sec. 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
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.
(A) Signs. Storage areas for contaminated clothing and equipment
shall have signs bearing the following legend:
DANGER
FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT
MAY CAUSE CANCER
CAUSES SKIN, EYE AND RESPIRATORY IRRITATION
DO NOT BREATHE VAPOR
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
DO NOT GET ON SKIN
* * * * *
(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 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 Sec. 1910.1200 and
Appendices A and B to Sec. 1910.1200, including cancer and respiratory
sensitization, and shall contain the hazard statement "may cause
cancer."
* * * * *
28. Amend Sec. 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:
Sec. 1910.1050 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: 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 Sec. 1910.1050 .
* * * * *
29. Amend Sec. 1910.1051 to revise paragraph (l)(1) as follows:
Sec. 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 Sec. 1910.1052 to revise paragraph (k) as follows:
Sec. 1910.1052 Methylene chloride.
* * * * *
(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
system effects, liver effects, and skin and eye irritation.
* * * * *
31. Amend Sec. 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 Sec. 1910.1200; redesignate
Appendix D to Sec. 1910.1200 as Appendix E to Sec. 1910.1200 and add
new Appendices A, B, C, D and F to Sec. 1910.1200.
The revisions and additions read as follows:
Sec. 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
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.
* * * * *
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 Sec. 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 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 Sec. 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 cross-references 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.
Trade secret means any confidential formula, pattern, process,
device, information or compilation of information that is used in an
employer's business, and that gives the employer an opportunity to
obtain an advantage over competitors who do not know or use it.
Appendix E to Sec. 1910.1200--Definition of Trade Secret, sets out the
criteria to be used in evaluating trade secrets.
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 Sec. 1910.1200 shall be
consulted for classification of health hazards, and Appendix B to Sec.
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 Sec. 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
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 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.
(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 Sec. 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.
(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.
(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 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 [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 Sec. 1910.1200--Health Hazard Criteria (Mandatory)
A.0 GENERAL CLASSIFICATION CONSIDERATIONS
A.0.1 Classification
A.0.1.1 The term "hazard classification" is used to indicate
that only the intrinsic hazardous properties of chemicals are
considered. Hazard classification incorporates three steps:
(a) identification of relevant data regarding the hazards of a
chemical;
(b) subsequent review of those data to ascertain the hazards
associated with the chemical;
(c) determination of whether the chemical will be classified as
hazardous and the degree of hazard.
A.0.1.2 For many hazard classes, the criteria are semi-
quantitative or qualitative and expert judgment is required to
interpret the data for classification purposes.
A.0.2 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 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 well-conducted animal studies are not necessarily
negated by the lack of positive human experience but require an
assessment of the robustness, quality and statistical power of both
the human and animal data.
A.0.3.4 Route of exposure, mechanistic information, and
metabolism studies are pertinent to determining the relevance of an
effect in humans. When such information raises doubt about relevance
in humans, a lower classification may be warranted. When there is
scientific evidence demonstrating that the mechanism or mode of
action is not relevant to humans, the chemical should not be
classified.
A.0.3.5 Both positive and negative results are 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 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 case-by-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.
These principles ensure that the classification process uses the
available data to the greatest extent possible in characterizing the
hazards of the mixture.
A.0.5.1.1 Dilution
For mixtures classified in accordance with A.1 through A.10 of
this Appendix, if a tested mixture is diluted with a diluent that
has an equivalent or lower toxicity classification than the least
toxic original ingredient, and which is not expected to affect the
toxicity of other ingredients, then:
(a) the new diluted mixture shall be classified as equivalent to
the original tested mixture; or
(b) for classification of acute toxicity in accordance with A.1
of this Appendix, paragraph A.1.3.6 (the additivity formula) shall
be applied.
A.0.5.1.2 Batching
For mixtures classified in accordance with A.1 through A.10 of
this Appendix, the toxicity of a tested production batch of a
mixture can be assumed to be substantially equivalent to that of
another untested production batch of the same 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 Appendix, if a tested mixture is classified in
Category 1, and the concentration of the ingredients of the tested
mixture that are in Category 1 is increased, the resulting untested
mixture shall be classified in Category 1.
A.0.5.1.4 Interpolation Within One Toxicity Category
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., 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 inhalation routes is the rat, while the rat
or rabbit are preferred for evaluation of acute dermal toxicity. Test
data already generated for the classification of chemicals under existing
systems should be accepted when reclassifying these chemicals under the
harmonized system. When experimental data for acute toxicity are available
in several animal species, scientific judgment should be used in selecting
the most appropriate LD50 value from among scientifically
validated tests.
A.1.3 Classification Criteria for Mixtures
A.1.3.1 The approach to classification of mixtures for acute
toxicity is tiered, and is dependent upon the amount of information
available for the mixture itself and for its ingredients. The flow
chart of Figure A.1.1 indicates the process that must be followed:
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A.1.3.2 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.
A.1.3.4 Classification of Mixtures Where Acute Toxicity Test Data Are
Available for the Complete Mixture
Where the mixture itself has been tested to determine its acute
toxicity, it is classified according to the same criteria as those
used for substances, presented in Table A.1.1. If test data for the
mixture are not available, the procedures presented below must be
followed.
A.1.3.5 Classification of Mixtures Where Acute Toxicity Test Data Are
Not Available for the Complete Mixture: Bridging Principles
A.1.3.5.1 Where the mixture itself has not been tested to
determine its acute toxicity, but there are sufficient data on both
the individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data will be used in
accordance with the following bridging principles as found in
paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration
of mixtures, Interpolation within one 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 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:
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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 toxicity estimate. In this
situation the mixture is classified based on the known ingredients
only. (Note: A statement that x percent of the mixture consists of
ingredient(s) of unknown 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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A.2 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 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.
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
Category 1: Corrosive Corrosive sub- -------------------------------------------------
categories Exposure Observation
----------------------------------------------------------------------------------------------------------------
1A..................... <= 3 min............... <= 1 h.
1B..................... > 3 min <= 1 h......... <= 14 days.
1C..................... > 1 h <= 4 h........... <= 14 days.
----------------------------------------------------------------------------------------------------------------
a The 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)........ (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.
------------------------------------------------------------------------
\a\ The 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.
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 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:
----------------------------------------------------------------
Skin irritant
Sum of ingredients classified as: -------------------------------------
Skin corrosive Category
Category 1 2
-------------------------------------------------------------------------------------------------------- ----------
Skin Category 1................................... >= 5%.................... >= 1% but < 5%.
Skin Category 2................................... ......................... >= 10%.
(10 x Skin Category 1) + Skin Category 2.......... ......................... >= 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
----------------------------------------------------------------------------------------------------------------
Mixture classified as: Skin
Ingredient: Concentration:
----------------------------------------------------------------------------------------------------------------
Acid with pH <= 2.................................... >= 1%....................... Category 1.
Base with pH >= 11.5................................. >= 1%....................... Category 1.
Other corrosive (Category 1) ingredients for which >= 1%....................... Category 1.
additivity does not apply.
Other irritant (Category 2) ingredients for which >= 3%....................... Category 2.
additivity does not apply, including acids and bases.
----------------------------------------------------------------------------------------------------------------
A.3 SERIOUS EYE DAMAGE /EYE IRRITATION
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 Classification Criteria for Substances Using Test Data
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 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.
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A.3.2.2 Reversible Effects on the Eye (Category 2)
A single category is provided in Table A.3.2 for substances that
have the potential to induce reversible eye irritation.
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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.
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 structure-activity relationships (SAR) or
structure-property 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 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 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-of-evidence decision, where appropriate, about hazard assessment
and hazard classification.
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A.3.4 Classification Criteria for Mixtures
A.3.4.1 Classification of Mixtures When Data Are Available for the
Complete Mixture
A.3.4.1.1 The mixture will be classified using the criteria for
substances, and taking into account the 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 toxicity category, Substantially similar mixtures, and
Aerosols.
A.3.4.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.3.4.3.1 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, 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).
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 Reversible eye effects
----------------------------------------------------------
Category 1 Category 2
----------------------------------------------------------------------------------------------------------------
Eye or skin Category 1............................... >= 3%....................... >= 1% but < 3%.
Eye Category 2....................................... ............................ >= 10%.
(10 x eye Category 1) + eye Category 2............... ............................ >= 10%.
Skin Category 1 + eye Category 1..................... >= 3%....................... >= 1% but < 3%.
10 x (skin Category 1 + eye Category 1) + eye ............................ >= 10%.
Category 2.
----------------------------------------------------------------------------------------------------------------
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: Concentration Mixture classified as: Eye
----------------------------------------------------------------------------------------------------------------
Acid with pH <= 2.................................... >= 1%....................... Category 1.
Base with pH >= 11.5................................. >= 1%....................... Category 1.
Other corrosive (Category 1) ingredients for which >= 1%....................... Category 1.
additivity does not apply.
Other irritant (Category 2) ingredients for which >= 3%....................... Category 2.
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.
A.4.1.3 For respiratory sensitization, the pattern of induction
followed by elicitation phases is shared in common with skin
sensitization. For skin sensitization, an induction phase is
required in which the immune system learns to react; clinical
symptoms can then arise when subsequent exposure is sufficient to
elicit a visible skin reaction (elicitation phase). As a
consequence, predictive tests usually follow this pattern in which
there is an induction phase, the response to which is measured by a
standardized elicitation phase, typically involving a patch test.
The local lymph node assay is the exception, directly measuring the
induction response. Evidence of skin sensitization in humans
normally is assessed by a diagnostic patch test.
A.4.1.4 Usually, for both skin and respiratory sensitization,
lower levels are necessary for elicitation than are required for
induction.
A.4.1.5 The hazard class "respiratory or skin sensitization"
is differentiated into:
(a) Respiratory sensitization; and
(b) Skin sensitization
A.4.2 Classification Criteria for Substances
A.4.2.1 Respiratory Sensitizers
A.4.2.1.1 Hazard Categories
A.4.2.1.1.1 Effects seen in either humans or animals will
normally justify classification in a weight of evidence approach for
respiratory sensitizers. Substances may be allocated to one of the
two sub-categories 1A or 1B using a weight of evidence approach in
accordance with the criteria given in Table A.4.1 and on the basis
of reliable and good quality evidence from human cases or
epidemiological studies and/or observations from appropriate studies
in experimental animals.
Table A.4.1--Hazard Category and Sub-Categories for Respiratory
Sensitizers
------------------------------------------------------------------------
Category 1: Respiratory sensitizer
------------------------------------------------------------------------
A substance is classified as a
respiratory sensitizer:
(a) if there is evidence in humans
that the substance can lead to
specific respiratory hypersensitivity
and/or
(b) if there are positive results from
an appropriate animal test.\19\
Sub-category 1A.............. Substances showing a high frequency of
occurrence in humans; or a probability
of occurrence of a high sensitization
rate in humans based on animal or other
tests.\1\ Severity of reaction may also
be considered.
Sub-category 1B.............. Substances showing a low to moderate
frequency of occurrence in humans; or a
probability of occurrence of a low to
moderate sensitization rate in humans
based on animal or other tests.\1\
Severity of reaction may also be
considered.
------------------------------------------------------------------------
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
A.4.2.1.2 Human evidence
A.4.2.1.2.1 Evidence that a substance can lead to specific
respiratory hypersensitivity will normally be based on human
experience. In this context, hypersensitivity is normally seen as
asthma, but other hypersensitivity reactions such as rhinitis/
conjunctivitis and alveolitis are also considered. The condition
will have the clinical character of an allergic reaction. However,
immunological mechanisms do not have to be demonstrated.
A.4.2.1.2.2 When considering the human evidence, it is necessary
that in addition to the evidence from the cases, the following be
taken into account:
(a) the size of the population exposed;
(b) the extent of exposure.
A.4.2.1.2.3 The evidence referred to above could be:
(a) clinical history and data from appropriate lung function
tests related to exposure to the substance, confirmed by other
supportive evidence which may include:
(i) in vivo immunological test (e.g., skin prick test);
(ii) in vitro immunological test (e.g., serological analysis);
(iii) studies that may indicate other specific hypersensitivity
reactions where immunological mechanisms of action have not been
proven, e.g., repeated low-level irritation, pharmacologically
mediated effects;
(iv) a chemical structure related to substances known to cause
respiratory hypersensitivity;
(b) data from positive bronchial challenge tests with the
substance conducted according to accepted guidelines for the
determination of a specific hypersensitivity reaction.
A.4.2.1.2.4 Clinical history should include both medical and
occupational history to determine a relationship between exposure to
a specific substance and development of respiratory
hypersensitivity. Relevant information includes aggravating factors
both in the home and workplace, the onset and progress of the
disease, family history and medical history of the patient in
question. The medical history should also include a note of other
allergic or airway disorders from childhood and smoking history.
A.4.2.1.2.5 The results of positive bronchial challenge tests
are considered to provide sufficient evidence for classification on
their own. It is, however, recognized that in practice many of the
examinations listed above will already have been carried out.
A.4.2.1.3 Animal Studies
A.4.2.1.3.1 Data from appropriate animal studies \1\ which may
be indicative of the potential of a substance to cause sensitization
by inhalation in humans \20\ may include:
---------------------------------------------------------------------------
\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 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.
---------------------------------------------------------------------------
(a) measurements of Immunoglobulin E (IgE) and other specific
immunological parameters, for example in mice;
(b) specific pulmonary responses in guinea pigs.
A.4.2.2 Skin Sensitizers
A.4.2.2.1 Hazard Categories
A.4.2.2.1.1 Effects seen in either humans or animals will
normally justify classification in a weight of evidence approach for
skin sensitizers. Substances may be allocated to one of the two sub-
categories 1A or 1B using a weight of evidence approach in
accordance with the criteria given in Table A.4.2 and on the basis
of reliable and good quality evidence from human cases or
epidemiological studies and/or observations from appropriate studies
in experimental animals according to the guidance values provided in
A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 1A and in A.4.2.2.2.2
and A.4.2.2.3.3 for sub-category 1B.
Table A.4.2--Hazard Category and Sub-Categories for Skin Sensitizers
------------------------------------------------------------------------
Category 1: Skin sensitizer
------------------------------------------------------------------------
A substance is classified as a skin
sensitizer:
(a) if there is evidence in humans
that the substance can lead to
sensitization by skin contact in a
substantial number of persons, or
(b) if there are positive results from
an appropriate animal test.
Sub-category 1A Substances showing a high frequency of
occurrence in humans and/or a high
potency in animals can be presumed to
have the potential to produce
significant sensitization in humans.
Severity of reaction may also be
considered.
Sub-category 1B Substances showing a low to moderate
frequency of occurrence in humans and/or
a low to moderate potency in animals can
be presumed to have the potential to
produce sensitization in humans.
Severity of reaction may also be
considered.
------------------------------------------------------------------------
A.4.2.2.2 Human Evidence
A.4.2.2.2.1 Human evidence for sub-category 1A may include:
(a) positive responses at <=500 [mu]g/cm\2\ (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 sub-category 1B may include:
(a) positive responses at >500 [mu]g/cm\2\ (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\
---------------------------------------------------------------------------
\21\ Test methods for skin sensitization are described in OECD
Guideline 406 (the Guinea Pig Maximization test and the Buehler
guinea pig test) and Guideline 429 (Local Lymph Node Assay). Other
methods may be used provided that they are scientifically validated.
The Mouse Ear Swelling Test (MEST), appears to be a reliable
screening test to detect moderate to strong sensitizers, and can be
used, in accordance with professional judgment, as a first stage in
the assessment of skin sensitization potential.
---------------------------------------------------------------------------
A.4.2.2.3.2 Animal test results for sub-category 1A can include
data with values indicated in Table A.4.3.
Table A.4.3--Animal Test Results for Sub-Category 1A
------------------------------------------------------------------------
Assay Criteria
------------------------------------------------------------------------
Local lymph node assay....... EC3 value <=2%.
Guinea pig maximization test. >=30% responding at <=0.1% intradermal
induction dose or
>=60% responding at >0.1% to <=1%
intradermal induction dose.
Buehler assay................ >=15% responding at <=0.2% topical
induction dose or
>=60% responding at >0.2% to <=20%
topical induction dose.
------------------------------------------------------------------------
A.4.2.2.3.3 Animal test results for sub-category 1B can include
data with values indicated in Table A.4.4 below:
Table A.4.4--Animal Test Results for Sub-Category 1B
------------------------------------------------------------------------
Assay Criteria
------------------------------------------------------------------------
Local lymph node assay....... EC3 value >2%.
Guinea pig maximization test. >=30% to <60% responding at >0.1% to <=1%
intradermal induction dose or
>=30% responding at >1% intradermal
induction dose.
Buehler assay................ >=15% to <60% responding at >0.2% to
<=20% topical induction dose or
>=15% responding at >20% topical
induction dose.
------------------------------------------------------------------------
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 case-control or other, less defined studies. Evaluation
of human data must, therefore, be carried out with caution as the
frequency of cases reflect, in addition to the inherent properties
of the substances, factors such as the exposure situation,
bioavailability, individual predisposition and preventive measures
taken. Negative human data should not normally be used to negate
positive results from animal studies. For both animal and human
data, consideration should be given to the impact of vehicle.
A.4.2.2.4.3 If none of the above-mentioned conditions are met,
the substance need not be classified as a skin sensitizer. However,
a combination of two or more indicators of skin sensitization, as
listed below, may alter the decision. This shall be considered on a
case-by-case basis.
(a) Isolated episodes of allergic contact dermatitis;
(b) Epidemiological studies of limited power, e.g., where
chance, bias or confounders have not been ruled out fully with
reasonable confidence;
(c) Data from animal tests, performed according to existing
guidelines, which do not meet the criteria for a positive result
described in A.4.2.2.3, but which are sufficiently close to the
limit to be considered significant;
(d) Positive data from non-standard methods;
(e) Positive results from close structural analogues.
A.4.2.2.4.4 Immunological Contact Urticaria
A.4.2.2.4.4.1 Substances meeting the criteria for classification
as respiratory sensitizers may, in addition, cause immunological
contact urticaria. Consideration shall be given to classifying these
substances as skin sensitizers.
A.4.2.2.4.4.2 Substances which cause immunological contact
urticaria without meeting the criteria for respiratory sensitizers
shall be considered for classification as skin sensitizers.
A.4.2.2.4.4.3 There is no recognized animal model available to
identify substances which cause immunological contact urticaria.
Therefore, classification will normally be based on human evidence,
similar to that for skin sensitization.
A.4.3 Classification Criteria for Mixtures
A.4.3.1 Classification of Mixtures When Data are Available for the
Complete Mixture
When reliable and good quality evidence, as described in the
criteria for substances, from human experience or appropriate
studies in experimental animals, is available for the mixture, then
the mixture 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.
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 Skin sensitizer
-------------------------------------------------- Category 1
------------------------
Solid/Liquid Gas All physical states
----------------------------------------------------------------------------------------------------------------
Respiratory sensitizer, Category 1... >=0.1%................. >=0.1%.................
Respiratory sensitizer, Sub-category >=0.1%................. >=0.1%.................
1A.
Respiratory sensitizer, Sub-category >=1.0%................. >=0.2%.................
1B.
Skin sensitizer, Category 1.......... ....................... ....................... >=0.1%.
Skin sensitizer, Sub-category 1A..... ....................... ....................... >=0.1%.
Skin sensitizer, Sub-category 1B..... ....................... ....................... >=1.0%.
----------------------------------------------------------------------------------------------------------------
A.5 GERM CELL MUTAGENICITY
A.5.1 Definitions and General Considerations
A.5.1.1 A mutation is defined as a permanent change in the
amount or structure of the genetic material in a cell. The term
mutation applies both to heritable genetic changes that may be
manifested at the phenotypic level and to the underlying DNA
modifications when known (including, for example, specific base pair
changes and chromosomal translocations). The term mutagenic and
mutagen will be used for agents giving rise to an increased
occurrence of mutations in populations of cells and/or organisms.
A.5.1.2 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 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.
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 Classification Criteria for Mixtures \22\
---------------------------------------------------------------------------
\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, 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.
---------------------------------------------------------------------------
A.5.3.1 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.5.3.1.1 Classification of mixtures shall be based on the
available test data for the individual ingredients of the mixture
using cut-off values/concentration limits for the ingredients
classified as germ cell mutagens.
A.5.3.1.2 The mixture will be classified as a mutagen when at
least one ingredient has been classified as a Category 1A, Category
1B or Category 2 mutagen and is present at or above the appropriate
cut-off value/concentration limit as shown in Table A.5.1 below for
Category 1 and 2 respectively.
Table A.5.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Germ Cell Mutagens
That Would Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
Cut-off/concentration limits triggering classification of
a mixture as:
Ingredient classified as: ----------------------------------------------------------
Category 1 mutagen Category 2 mutagen
----------------------------------------------------------------------------------------------------------------
Category 1A/B mutagen................................ >= 0.1%.....................
Category 2 mutagen................................... ............................ >= 1.0%.
----------------------------------------------------------------------------------------------------------------
Note: The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well
as gases (v/v units).
A.5.3.2 Classification of Mixtures When Data Are Available for the
Mixture Itself
The classification may be modified on a case-by-case basis based
on the available test data for the mixture as a whole. In such
cases, the test results for the mixture as a whole must be shown to
be conclusive taking into account dose and other factors such as
duration, observations and analysis (e.g. statistical analysis, test
sensitivity) of germ cell mutagenicity test systems.
A.5.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.5.3.3.1 Where the mixture itself has not been tested to
determine its germ cell mutagenicity hazard, but there are
sufficient data on both the individual ingredients and similar
tested mixtures to adequately characterize the hazards of the
mixture, these data will be used in accordance with the following
bridging principles as found in paragraph A.0.5 of this Appendix:
Dilution, Batching, and Substantially similar mixtures.
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)
As new, scientifically validated, tests arise, these may also be
used in the total weight of evidence to be considered.
A.6 CARCINOGENICITY
A.6.1 Definitions
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\
---------------------------------------------------------------------------
\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.6.2.1 For the purpose of classification for carcinogenicity,
substances are allocated to one of two categories based on strength
of evidence and additional weight of evidence considerations. In
certain instances, route-specific classification may be warranted.
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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 one-step, criterion-based
process that involves two interrelated determinations: Evaluations
of strength of evidence and consideration of all other relevant
information to place substances with human cancer potential into
hazard categories.
A.6.2.4 Strength of evidence involves the enumeration of tumors
in human and animal studies and determination of their level of
statistical significance. Sufficient human evidence demonstrates
causality between human exposure and the development of cancer,
whereas sufficient evidence in animals shows a causal relationship
between the agent and an increased incidence of tumors. Limited
evidence in humans is demonstrated by a positive association between
exposure and cancer, but a causal relationship cannot be stated.
Limited evidence in animals is provided when data suggest a
carcinogenic effect, but are less than sufficient. (Guidance on
consideration of important factors in the classification of
carcinogenicity and a more detailed description of the terms
"limited" and "sufficient" have been developed by the
International Agency for Research on Cancer (IARC) and are provided
in 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 depends upon the amount
and coherence of evidence bearing on each. Generally there is a
requirement for more complete information to decrease than to
increase the level of concern. Additional considerations should be
used in evaluating the tumor findings and the other factors in a
case-by-case manner.
A.6.2.5.2 Some important factors which may be taken into
consideration, when assessing the overall level of concern are:
(a) Tumor type and background incidence;
(b) Multisite responses;
(c) Progression of lesions to malignancy;
(d) Reduced tumor latency;
Additional factors which may increase or decrease the level of
concern include:
(e) Whether responses are in single or both sexes;
(f) Whether responses are in a single species or several
species;
(g) Structural similarity or not to a substance(s) for which
there is good evidence of carcinogenicity;
(h) Routes of exposure;
(i) Comparison of absorption, distribution, metabolism and
excretion between test animals and humans;
(j) The possibility of a confounding effect of excessive
toxicity at test doses; and,
(k) Mode of action and its relevance for humans, such as
mutagenicity, cytotoxicity with growth stimulation, mitogenesis,
immunosuppression.
Mutagenicity: It is recognized that genetic events are central
in the overall process of cancer development. Therefore evidence of
mutagenic activity in vivo may indicate that a substance has a
potential for carcinogenic effects.
A.6.2.5.3 A substance that has not been tested for
carcinogenicity may in certain instances be classified in Category
1A, Category 1B, or Category 2 based on tumor data from a structural
analogue together with substantial support from consideration of
other important factors such as formation of common significant
metabolites, e.g., for benzidine congener dyes.
A.6.2.5.4 The classification should also take into consideration
whether or not the substance is absorbed by a given route(s); or
whether there are only local tumors at the site of administration
for the tested route(s), and adequate testing by other major
route(s) show lack of carcinogenicity.
A.6.2.5.5 It is important that whatever is known of the physico-
chemical, toxicokinetic and toxicodynamic properties of the
substances, as well as any available relevant information on
chemical analogues, i.e., structure activity relationship, is taken
into consideration when undertaking classification.
A.6.3 Classification Criteria for Mixtures \24\
---------------------------------------------------------------------------
\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, 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 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.
---------------------------------------------------------------------------
A.6.3.1 The mixture shall be classified as a carcinogen when at
least one ingredient has been classified as a Category 1 or Category
2 carcinogen and is present at or above the appropriate cut-off
value/concentration limit as shown in Table A.6.1.
Table A.6.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Carcinogen That Would
Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
Ingredient classified as: Category 1 carcinogen Category 2 carcinogen
----------------------------------------------------------------------------------------------------------------
Category 1 carcinogen................................ >= 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
Where the mixture itself has not been tested to determine its
carcinogenic hazard, but there are sufficient data on both the
individual ingredients and similar tested mixtures to adequately
characterize the hazards of the mixture, these data will be used in
accordance with the following bridging principles as found in
paragraph A.0.5 of this Appendix: Dilution; Batching; and
Substantially similar mixtures.
A.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 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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A.7.2.2 Basis of Classification
A.7.2.2.1 Classification is made on the basis of the criteria,
outlined above, an assessment of the total weight of evidence, and
the use of expert judgment. Classification as a reproductive
toxicant is intended to be used for substances which have an
intrinsic, specific property to produce an adverse effect on reproduction
and substances should not be so classified if such an effect is produced
solely as a non-specific secondary consequence of other toxic
effects.
A.7.2.2.2 In the evaluation of toxic effects on the developing
offspring, it is important to consider the possible influence of
maternal toxicity.
A.7.2.2.3 For human evidence to provide the primary basis for a
Category 1A classification there must be reliable evidence of an
adverse effect on reproduction in humans. Evidence used for
classification shall be from well conducted epidemiological studies,
if available, which include the use of appropriate controls,
balanced assessment, and due consideration of bias or confounding
factors. Less rigorous data from studies in humans may be sufficient
for a Category 1A classification if supplemented with adequate data
from studies in experimental animals, but classification in Category
1B may also be considered.
A.7.2.3 Weight of Evidence
A.7.2.3.1 Classification as a reproductive toxicant is made on
the basis of an assessment of the total weight of evidence using
expert judgment. This means that all available information that
bears on the determination of reproductive toxicity is considered
together. Included is information such as epidemiological studies
and case reports in humans and specific reproduction studies along
with sub-chronic, chronic and special study results in animals that
provide relevant information regarding toxicity to reproductive and
related endocrine organs. Evaluation of substances chemically
related to the material under study may also be included,
particularly when information on the material is scarce. The weight
given to the available evidence will be influenced by factors such
as the quality of the studies, consistency of results, nature and
severity of effects, level of statistical significance for
intergroup differences, number of endpoints affected, relevance of
route of administration to humans and freedom from bias. Both
positive and negative results are 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 classification may not
necessarily be the outcome. These effects include, for example,
small changes in semen parameters or in the incidence of spontaneous
defects in the fetus, small changes in the proportions of common
fetal variants such as are observed in skeletal examinations, or in
fetal weights, or small differences in postnatal developmental
assessments.
A.7.2.3.4 Data from animal studies shall provide sufficient
evidence of specific reproductive toxicity in the absence of other
systemic toxic effects. However, if developmental toxicity occurs
together with other toxic effects in the dam (mother), the potential
influence of the generalized adverse effects should be assessed to
the extent possible. The preferred approach is to consider adverse
effects in the embryo/fetus first, and then evaluate maternal
toxicity, along with any other factors which are likely to have
influenced these effects, as part of the weight of evidence. In
general, developmental effects that are observed at maternally toxic
doses should not be automatically discounted. Discounting
developmental effects that are observed at maternally toxic doses
can only be done on a case-by-case basis when a causal relationship
is established or refuted.
A.7.2.3.5 If appropriate information is available it is
important to try to determine whether developmental toxicity is due
to a specific maternally mediated mechanism or to a non-specific
secondary mechanism, like maternal stress and the disruption of
homeostasis. Generally, the presence of maternal toxicity should not
be used to negate findings of embryo/fetal effects, unless it can be
clearly demonstrated that the effects are secondary non-specific
effects. This is especially the case when the effects in the
offspring are significant, e.g., irreversible effects such as
structural malformations. In some situations it is reasonable to
assume that reproductive toxicity is due to a secondary consequence
of maternal toxicity and discount the effects, for example if the
chemical is so toxic that dams fail to thrive and there is severe
inanition; they are incapable of nursing pups; or they are prostrate
or dying.
A.7.2.4 Maternal Toxicity
A.7.2.4.1 Development of the offspring throughout gestation and
during the early postnatal stages can be influenced by toxic effects
in the mother either through non-specific mechanisms related to
stress and the disruption of maternal homeostasis, or by specific
maternally-mediated mechanisms. So, in the interpretation of the
developmental outcome to decide classification for developmental
effects it is important to consider the possible influence of
maternal toxicity. This is a complex issue because of uncertainties
surrounding the relationship between maternal toxicity and
developmental outcome. Expert judgment and a weight of evidence
approach, using all available studies, shall be used to determine
the degree of influence to be attributed to maternal toxicity when
interpreting the criteria for classification for developmental
effects. The adverse effects in the embryo/fetus shall be first
considered, and then maternal toxicity, along with any other factors
which are likely to have influenced these effects, as weight of
evidence, to help reach a conclusion about classification.
A.7.2.4.2 Based on pragmatic observation, it is believed that
maternal toxicity may, depending on severity, influence development
via non-specific secondary mechanisms, producing effects such as
depressed fetal weight, retarded ossification, and possibly
resorptions and certain malformations in some strains of certain
species. However, the limited numbers of studies which have
investigated the relationship between developmental effects and
general maternal toxicity have failed to demonstrate a consistent,
reproducible relationship across species. Developmental effects
which occur even in the presence of maternal toxicity are considered
to be evidence of developmental toxicity, unless it can be
unequivocally demonstrated on a case by case basis that the
developmental effects are secondary to maternal toxicity. Moreover,
classification shall be considered where there is a significant
toxic effect in the offspring, e.g., irreversible effects such as
structural malformations, embryo/fetal lethality, or significant
post-natal functional deficiencies.
A.7.2.4.3 Classification shall not automatically be discounted
for chemicals that produce developmental toxicity only in
association with maternal toxicity, even if a specific maternally-
mediated mechanism has been demonstrated. In such a case,
classification in Category 2 may be considered more appropriate than
Category 1. However, when a chemical is so toxic that maternal death
or severe inanition results, or the dams (mothers) are prostrate and
incapable of nursing the pups, it is reasonable to assume that
developmental toxicity is produced solely as a secondary consequence
of maternal toxicity and discount the developmental effects.
Classification is not necessarily the outcome in the case of minor
developmental changes, e.g., a small reduction in fetal/pup body
weight or retardation of ossification when seen in association with
maternal toxicity.
A.7.2.4.4 Some of the endpoints used to assess maternal toxicity
are provided below. Data on these endpoints, if available, shall be
evaluated in light of their statistical or biological significance
and dose-response relationship.
(a) Maternal mortality: An increased incidence of mortality
among the treated dams over the controls shall be considered
evidence of maternal toxicity if the increase occurs in a dose-
related manner and can be attributed to the systemic toxicity of the
test material. Maternal mortality greater than 10% is considered
excessive and the data for that dose level shall not normally be
considered to need further evaluation.
(b) Mating index (Number of animals with seminal plugs or sperm/
Number of mated x 100)
(c) Fertility index (Number of animals with implants/Number of
matings x 100)
(d) Gestation length (If allowed to deliver)
(e) Body weight and body weight change: Consideration of the
maternal body weight change and/or adjusted (corrected) maternal
body weight shall be included in the evaluation of maternal toxicity
whenever such data are available. The calculation of an adjusted (corrected)
mean maternal body weight change, which is the difference between
the initial and terminal body weight minus the gravid uterine weight
(or alternatively, the sum of the weights of the fetuses), may
indicate whether the effect is maternal or intrauterine. In rabbits,
the body weight gain may not be 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-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 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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
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 Category 2 Additional category
reproductive reproductive for effects on or
toxicant toxicant via lactation
----------------------------------------------------------------------------------------------------------------
Category 1 reproductive toxicant.............. >=0.1%..............
Category 2 reproductive toxicant.............. .................... >=0.1%..............
Additional category for effects on or via .................... >=0.1%..............
lactation.
----------------------------------------------------------------------------------------------------------------
A.7.3.2 Classification of mixtures when data are available for the
complete mixture
Available test data for the mixture as a whole may be used for
classification on a case-by-case basis. In such cases, the test
results for the mixture as a whole must be shown to be conclusive
taking into account dose and other factors such as duration,
observations and analysis (e.g., statistical analysis, test
sensitivity) of reproduction test systems.
A.7.3.3 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.7.3.3.1 Where the mixture itself has not been tested to
determine its reproductive toxicity, but there are sufficient data
on both the individual ingredients and similar tested mixtures to
adequately characterize the hazards of the mixture, these data shall
be used in accordance with the following bridging principles as
found in paragraph A.0.5 of this Appendix: Dilution, Batching, and
Substantially similar mixtures.
A.8 SPECIFIC TARGET ORGAN TOXICITY SINGLE EXPOSURE
A.8.1 Definitions and General Considerations
A.8.1.1 Specific target organ toxicity--single exposure, (STOT-
SE) means specific, 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
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.
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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.
A.8.2.1.6 In exceptional cases, based on expert judgment, it may
be appropriate to place certain substances with human evidence of
target organ toxicity in Category 2: (a) when the weight of human
evidence is not sufficiently convincing to warrant Category 1
classification, and/or (b) based on the nature and severity of
effects. Dose/concentration levels in humans shall not be considered
in the classification and any available evidence from animal studies
shall be consistent with the Category 2 classification. In other
words, if there are also animal data available on the substance that
warrant Category 1 classification, the chemical shall be classified
as Category 1.
A.8.2.1.7 Effects considered to support classification for
Category 1 and 2
A.8.2.1.7.1 Classification is supported by evidence associating
single exposure to the substance with a consistent and identifiable
toxic effect.
A.8.2.1.7.2 Evidence from human experience/incidents is usually
restricted to reports of adverse health consequences, often with
uncertainty about exposure conditions, and may not provide the
scientific detail that can be obtained from well-conducted studies
in experimental animals.
A.8.2.1.7.3 Evidence from appropriate studies in experimental
animals can furnish much more detail, in the form of clinical
observations, and macroscopic and microscopic pathological
examination and this can often reveal hazards that may not be life-
threatening but could indicate functional impairment. Consequently
all available evidence, and 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;
(d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;
(e) Multi-focal or diffuse necrosis, fibrosis or granuloma
formation in vital organs with regenerative capacity;
(f) Morphological changes that are potentially reversible but
provide clear evidence of marked organ dysfunction; and,
(g) Evidence of appreciable cell death (including cell
degeneration and reduced cell number) in vital organs incapable of
regeneration.
A.8.2.1.8 Effects considered not to support classification for
Category 1 and 2
Effects may be seen in humans and/or animals that do not justify
classification. Such effects include, but are not limited to:
(a) Clinical observations or small changes in bodyweight gain,
food consumption or water intake that may have some toxicological
importance but that do not, by themselves, indicate "significant"
toxicity;
(b) Small changes in clinical biochemistry, hematology or
urinalysis parameters and/or transient effects, when such changes or
effects are of doubtful or of minimal toxicological importance;
(c) Changes in organ weights with no evidence of organ
dysfunction;
(d) Adaptive responses that are not considered toxicologically
relevant; and,
(e) Substance-induced species-specific mechanisms of toxicity,
i.e., demonstrated with reasonable certainty to be not relevant for
human health, shall not justify classification.
A.8.2.1.9 Guidance values to assist with classification based on
the results obtained from studies conducted in experimental animals
for Category 1 and 2
A.8.2.1.9.1 In order to help reach a decision about whether a
substance shall be classified or not, and to what degree it shall be
classified (Category 1 vs. Category 2), dose/concentration
"guidance values" are provided for consideration of the dose/
concentration which has been shown to produce significant health
effects. The principal argument for proposing such guidance values
is that all chemicals are potentially toxic and there has to be a
reasonable dose/concentration above which a degree of toxic effect
is acknowledged.
A.8.2.1.9.2 Thus, in animal studies, when significant toxic
effects are observed that indicate classification, consideration of
the dose/concentration at which these effects were seen, in relation
to the suggested guidance values, provides useful information to
help assess the need to classify (since the toxic effects are a
consequence of the hazardous property(ies) and also the dose/
concentration).
A.8.2.1.9.3 The guidance value (C) ranges for single-dose
exposure which has produced a significant non-lethal toxic effect
are those applicable to acute toxicity testing, as indicated in
Table A.8.1.
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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 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 judgment-based extrapolation from a structural analogue that
has previously been classified together with substantial support
from consideration of other important factors such as formation of
common significant metabolites.
A.8.2.2 Substances of Category 3
A.8.2.2.1 Criteria for Respiratory Tract Irritation
The criteria for classifying substances as Category 3 for
respiratory tract irritation are:
(a) Respiratory irritant effects (characterized by localized
redness, edema, pruritis and/or pain) that impair function with
symptoms such as cough, pain, choking, and breathing difficulties
are included. It is recognized that this evaluation is based
primarily on human data;
(b) Subjective human observations supported by objective
measurements of clear respiratory tract irritation (RTI) (e.g.,
electrophysiological responses, biomarkers of inflammation in nasal
or bronchoalveolar lavage fluids);
(c) The symptoms observed in humans shall also be typical of
those that would be produced in the exposed population rather than
being an isolated idiosyncratic reaction or response triggered only
in individuals with hypersensitive airways. Ambiguous reports simply
of "irritation" should be excluded as this term is commonly used
to describe a wide range of sensations including those such as
smell, unpleasant taste, a tickling sensation, and dryness, which
are outside the scope of classification for respiratory track
irritation;
(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 Category 2
----------------------------------------------------------------------------------------------------------------
Category 1 Target organ toxicant..................... >= 1.0%.....................
Category 2 Target organ toxicant..................... ............................ >= 1.0%
----------------------------------------------------------------------------------------------------------------
A.8.3.4.2 These cut-off values and consequent classifications
shall be applied equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.8.3.4.3 Mixtures shall be classified for either or both single
and repeated dose toxicity independently.
A.8.3.4.4 Care shall be exercised when toxicants affecting more
than one organ system are combined that the potentiation or
synergistic interactions are considered, because certain substances
can cause target organ toxicity at < 1% concentration when other
ingredients in the mixture are known to potentiate its toxic effect.
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. 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 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,
including the use of recommended guidance values which take into
account the duration of exposure and the dose/concentration which
produced the effect(s), (see A.9.2.9). Substances shall be placed in
one of two categories, depending upon the nature and severity of the
effect(s) observed, in accordance with Figure A.9.1.
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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 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 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
Route of exposure Units (dose/
concentration)
------------------------------------------------------------------------
Oral (rat)...................... mg/kg body weight/ C <= 10.
day.
Dermal (rat or rabbit).......... mg/kg body weight/ C <= 20.
day.
Inhalation (rat) gas............ ppmV/6h/day....... C <= 50.
Inhalation (rat) vapor.......... mg/liter/6h/day... C <= 0.2.
Inhalation (rat) dust/mist/fume. mg/liter/6h/day... C <= 0.02.
------------------------------------------------------------------------
A.9.2.9.7 For Category 2 classification, significant toxic
effects observed in a 90-day repeated-dose study conducted in
experimental animals and seen to occur within the (suggested)
guidance value ranges as indicated in Table A.9.2 would justify
classification:
Table A.9.2--Guidance Values To Assist in Category 2 Classification
[Applicable to a 90-day study]
------------------------------------------------------------------------
Guidance value
Route of exposure Units range (dose/
concentration)
------------------------------------------------------------------------
Oral (rat)...................... mg/kg body weight/ 10 < C <= 100.
day.
Dermal (rat or rabbit).......... mg/kg body weight/ 20 < C <= 200.
day.
Inhalation (rat) gas............ ppmV/6h/day....... 50 < C <= 250.
Inhalation (rat) vapor.......... mg/liter/6h/day... 0.2 < C <= 1.0.
Inhalation (rat) dust/mist/fume. mg/liter/6h/day... 0.02 < C <= 0.2.
------------------------------------------------------------------------
A.9.2.9.8 The guidance values and ranges mentioned in A.2.9.9.6
and A.2.9.9.7 are intended only for guidance purposes, i.e., to be
used as part of the weight of evidence approach, and to assist with
decisions about classification. They are not intended as strict
demarcation values.
A.9.2.9.9 Thus, it is feasible that a specific profile of
toxicity occurs in repeat-dose animal studies at a dose/
concentration below the guidance value, e.g., < 100 mg/kg body
weight/day by the oral route; however the nature of the effect,
e.g., nephrotoxicity seen only in male rats of a particular strain
known to be susceptible to this effect, may result in the decision
not to classify. Conversely, a specific profile of toxicity may be
seen in animal studies occurring at 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 Category 2
----------------------------------------------------------------------------------------------------------------
Category 1: Target organ toxicant.................... >= 1.0%. ...........................
Category 2: Target organ toxicant.................... ............................ >= 1.0%.
----------------------------------------------------------------------------------------------------------------
A.9.3.4.2 These cut-off values and consequent classifications
shall be applied equally and appropriately to both single- and
repeated-dose target organ toxicants.
A.9.3.4.3 Mixtures shall be classified for either or both
single- and repeated-dose toxicity independently.
A.9.3.4.4 Care shall be exercised when toxicants affecting more
than one organ system are combined that the potentiation or
synergistic interactions are considered, because certain substances
can cause specific target organ toxicity at < 1% concentration when
other ingredients in the mixture are known to potentiate its toxic
effect. See A.0.2.1.
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 respiratory and digestive
tracts in the laryngopharyngeal region.
A.10.1.4 Aspiration of a substance or mixture can occur as it is
vomited following ingestion. This may have consequences for
labeling, particularly where, due to acute toxicity, a
recommendation may be considered to induce vomiting after ingestion.
However, if the substance/mixture also presents an aspiration
toxicity hazard, the recommendation to induce vomiting may need to
be modified.
A.10.1.5 Specific Considerations
A.10.1.5.1 The classification criteria refer to kinematic
viscosity. The following provides the conversion between dynamic and
kinematic viscosity:
[GRAPHIC] [TIFF OMITTED] TP30SE09.140
A.10.1.5.2 Although the definition of aspiration in A.10.1.1
includes the entry of solids into the respiratory system,
classification according to (b) in table A.10.1 for Category 1 is
intended to apply to liquid substances and mixtures only.
A.10.1.5.3 Classification of Aerosol/Mist Products
Aerosol and mist products are usually dispensed in containers
such as self-pressurized containers, trigger and pump sprayers.
Classification for these products shall be considered if their use
may form a pool of product in the mouth, which then may be
aspirated. If the mist or aerosol from a pressurized container is
fine, a pool may not be formed. On the other hand, if a pressurized
container dispenses product in a stream, a pool may be formed that
may then be aspirated. Usually, the mist produced by trigger and
pump sprayers is coarse and therefore, a pool may be formed that
then may be aspirated. When the pump mechanism may be removed and
contents are available to be swallowed then the classification of
the products should be considered.
A.10.2 Classification Criteria for Substances
Table A.10.1--Criteria for Aspiration Toxicity
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
Category 1: Chemicals known to A substance shall be classified in
cause human aspiration toxicity Category 1:
hazards or to be regarded as if (a) If reliable and good quality
they cause human aspiration human evidence indicates that it
toxicity hazard. causes aspiration toxicity (See
note 1); or
(b) If it is a hydrocarbon and has a
kinematic viscosity <= 20.5 mm\2\/
s, measured at 40 °C.
------------------------------------------------------------------------
Note 1: Examples of substances included in Category 1 are certain
hydrocarbons, turpentine and pine oil.
A.10.3 Classification Criteria for Mixtures
A.10.3.1 Classification When Data Are Available for the Complete
Mixture
A mixture shall be classified in Category 1 based on reliable
and good quality human evidence.
A.10.3.2 Classification of Mixtures When Data Are Not Available for the
Complete Mixture: Bridging Principles
A.10.3.2.1 Where the mixture itself has not been tested to
determine its aspiration toxicity, but there are sufficient data on
both the individual ingredients and similar tested mixtures to
adequately characterize the hazard of the mixture, these data shall
be used in accordance with the following bridging principles as
found in paragraph A.0.5 of this Appendix: Dilution; Batching;
Concentration of mixtures; Interpolation within one toxicity
category; and Substantially similar mixtures. For application of the
dilution bridging principle, the concentration of aspiration
toxicants shall not be less than 10%.
A.10.3.3 Classification of Mixtures When Data Are Available for All
Ingredients or Only for Some Ingredients of the Mixture
A.10.3.3.1 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.
Appendix B to Sec. 1910.1200--Physical Hazard Criteria (Mandatory)
B.1 EXPLOSIVES
B.1.1 Definitions and General Considerations
B.1.1.1 An explosive chemical is a solid or liquid chemical
which is in itself capable by chemical reaction of producing gas at
such a temperature and pressure and at such a speed as to cause
damage to the surroundings. Pyrotechnic chemicals are included even
when they do not evolve gases.
A pyrotechnic chemical is a chemical designed to produce an
effect by heat, light, sound, gas or smoke or a combination of these
as the result of non-detonative self-sustaining exothermic chemical
reactions.
An explosive item is an item containing one or more explosive
chemicals.
A pyrotechnic item is an item containing one or more pyrotechnic
chemicals.
An unstable explosive is an explosive which is thermally
unstable and/or too sensitive for normal handling, transport, or
use.
An intentional explosive is a chemical or item which is
manufactured with a view to produce a practical explosive or
pyrotechnic effect.
B.1.1.2 The class of explosives comprises:
(a) Explosive chemicals;
(b) Explosive items, except devices containing explosive
chemicals in such quantity or of such a character that their
inadvertent or accidental ignition or initiation shall not cause any
effect external to the device either by projection, fire, smoke,
heat or loud noise; and
(c) Chemicals and items not included under (a) and (b) above
which are manufactured with the view to producing a practical
explosive or pyrotechnic effect.
B.1.2 Classification Criteria
Chemicals and items of this class shall be classified as
unstable explosives or shall be assigned to one of the following six
divisions depending on the type of hazard they present:
(a) Division 1.1 Chemicals and items which have a mass explosion
hazard (a mass explosion is one which affects almost the entire
quantity present virtually instantaneously);
(b) Division 1.2 Chemicals and items which have a projection
hazard but not a mass explosion hazard;
(c) Division 1.3 Chemicals and items which have a fire hazard
and either a minor blast hazard or a minor projection hazard or
both, but not a mass explosion hazard:
(i) combustion of which gives rise to considerable radiant heat;
or
(ii) which burn one after another, producing minor blast or
projection effects or both;
(d) Division 1.4 Chemicals and items which present no
significant hazard: chemicals and items which present only a small
hazard in the event of ignition or initiation. The effects are
largely confined to the package and no projection of fragments of
appreciable size or range is to be expected. An external fire shall
not cause virtually instantaneous explosion of almost the entire
contents of the package;
(e) Division 1.5 Very insensitive chemicals which have a mass
explosion hazard: chemicals which have a mass explosion hazard but
are so insensitive that there is very little probability of
initiation or of transition from burning to detonation under normal
conditions;
(f) Division 1.6 Extremely insensitive items which do not have a
mass explosion hazard: items which contain only extremely
insensitive detonating chemicals and which demonstrate a negligible
probability of accidental initiation or propagation.
B.1.3 Additional Classification Considerations
B.1.3.1 Explosives shall be classified as unstable explosives or
shall be assigned to one of the six divisions identified in B.1.2 in
accordance with the three step procedure in Part I of the UN
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.
The oxygen balance is calculated for the chemical reaction:
CxHyOz + [x + (y/4)-(z/2)]
O2 [rarr] x. CO2 + (y/2) H2O
using the formula: oxygen balance = -1600 [2x +(y/2) -z]/
molecular weight;
(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.
2.................................... 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.
------------------------------------------------------------------------
Note: Aerosols should not be classified as flammable gases. See
B.3.
B.2.3 Additional Classification Considerations
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.
B.3 FLAMMABLE AEROSOLS
B.3.1 Definition
Aerosol means any non-refillable receptacle containing a gas
compressed, liquefied or dissolved under pressure, and fitted with a
release device allowing the contents to be ejected as particles in
suspension in a gas, or as a foam, paste, powder, liquid or gas.
B.3.2 Classification Criteria
B.3.2.1 Aerosols 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 water-reactive 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.
Table B.3.1--Criteria for Flammable Aerosols
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1............................. 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.
2............................. Contains > 1% flammable components, or
the heat of combustion is >= 20 kJ/g;
and
(a) for spray aerosols, in the
ignition distance test, ignition
occurs at a distance >= 15 cm, 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 Additional Classification Considerations
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 ([Delta]Hc), in
kilojoules per gram (kJ/g), is the product of the theoretical heat
of combustion ([Delta]Hcomb), and a combustion efficiency, usually
less than 1.0 (a typical combustion efficiency is 0.95 or 95%).
For a composite aerosol formulation, the chemical heat of
combustion is the summation of the weighted heats of combustion for
the individual components, as follows:
[GRAPHIC] [TIFF OMITTED] TP30SE09.141
Where:
[Delta]Hc = chemical heat of combustion (kJ/g);
wi% = mass fraction of component i in the product;
[Delta]Hc(i) = specific heat of combustion (kJ/g) of component i in
the product;
The chemical heats of combustion shall be found in literature,
calculated or determined by tests (see ASTM D240-02(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 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.
B.4 OXIDIZING GASES
B.4.1 Definition
Oxidizing gas means any gas which may, generally by providing
oxygen, cause or contribute to the combustion of other material more
than air does.
Note: "Gases which cause or contribute to the combustion of
other material more than air does" means pure gases or gas mixtures
with an oxidizing power greater than 23.5% (as determined, by a
method specified in ISO 10156:1996 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
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 liquefied or liquefied and refrigerated. They comprise
compressed gases, liquefied gases, dissolved gases and refrigerated
liquefied gases.
B.5.2 Classification Criteria
Gases under pressure shall be classified in one of four groups
in accordance with Table B.5.1:
Table B.5.1--Criteria for Gases Under Pressure
------------------------------------------------------------------------
Group Criteria
------------------------------------------------------------------------
Compressed gas.................... A gas which when under pressure is
entirely gaseous at -50 °C (-58
°F); including all gases with a
critical temperature \1\ <= -50
°C (-58 °F).
Liquefied gas..................... 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
temperature\1\ 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).
Refrigerated liquefied gas........ A gas which is made partially liquid
because of its low temperature.
Dissolved gas..................... A gas which when under pressure is
dissolved in a liquid phase
solvent.
------------------------------------------------------------------------
(1) The critical temperature is the temperature above which a pure gas
cannot be liquefied, regardless of the degree of compression.
B.6 FLAMMABLE LIQUIDS
B.6.1 Definition
Flammable liquid means a liquid having a flash point of not more
than 93 °C (199.4 °F).
B.6.2 Classification Criteria
A flammable liquid shall be classified in one of four categories
in accordance with Table B.6.1:
Table B.6.1--Criteria for Flammable Liquids
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1................................. Flash point <23 °C (73.4 °F)
and initial boiling point <= 35
°C (95 °F).
2................................. Flash point <23 °C (73.4 °F)
and initial boiling point > 35
°C (95 °F).
3................................. Flash point >= 23 °C (73.4
°F) and <= 60 °C (140
°F).
4................................. Flash point > 60 °C (140 °F)
and <= 93 °C (199.4 °F).
------------------------------------------------------------------------
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).
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, sub-section 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................................. Burning rate test:
Chemicals other than metal powders:
(a) wetted zone does not stop
fire; and
(b) burning time < 45 s or
burning rate > 2.2 mm/s.
Metal powders: burning time <= 5
min.
2................................. Burning rate test:
Chemicals other than metal powders:
(a) wetted zone stops the fire
for at least 4 min; and
(b) burning time < 45 s or
burning rate > 2.2 mm/s.
Metal powders: burning time > 5 min
and <= 10 min.
------------------------------------------------------------------------
Note: 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 SELF-REACTIVE CHEMICALS
B.8.1 Definitions
Self-reactive chemicals are thermally unstable liquid or solid
chemicals liable to undergo a strongly exothermic decomposition even
without participation of oxygen (air). This definition excludes
chemicals classified under this section as explosives, organic
peroxides, oxidizing liquids or oxidizing solids.
A self-reactive chemical is regarded as possessing explosive
properties when in laboratory testing the formulation is liable to
detonate, to deflagrate rapidly or to show a violent effect when
heated under confinement.
B.8.2 Classification Criteria
B.8.2.1 A self-reactive chemical shall be considered for
classification in this class unless:
(a) It is classified as an explosive according to B.1 of this
appendix;
(b) It is classified as an oxidizing liquid or an oxidizing
solid according to B.13 or B.14 of this appendix, except that a
mixture of oxidizing substances which contains 5% or more of
combustible organic substances shall be classified as a self-
reactive chemical according to the procedure defined in B.8.2.2;
(c) It is classified as an organic peroxide according to B.15 of
this appendix;
(d) Its heat of decomposition is less than 300 J/g; or
(e) Its self-accelerating decomposition temperature (SADT) is
greater than 75 °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.
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 self-reactive
chemical TYPE F;
(g) Any self-reactive chemical which, in laboratory testing,
neither detonates in the cavitated state nor deflagrates at all and
shows no effect when heated under confinement nor any explosive
power, provided that it is thermally stable (self-accelerating
decomposition temperature is 60 °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.8.3.1 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.
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 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
The classification procedure for pyrophoric liquids need not be
applied when experience in production or handling shows that the
chemical does not ignite spontaneously on coming into contact with
air at normal temperatures (i.e. the substance is known to be stable
at room temperature for prolonged periods of time (days)).
B.10 PYROPHORIC SOLIDS
B.10.1 Definition
Pyrophoric solid means a solid which, even in small quantities,
is liable to ignite within five minutes after coming into contact
with air.
B.10.2 Classification Criteria
A pyrophoric solid shall be classified in a single category for
this class using test N.2 in Part III, sub-section 33.3.1.4 of the
UN 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
------------------------------------------------------------------------
1................................. The solid ignites within 5 min of
coming into contact with air.
------------------------------------------------------------------------
Note: Classification of solid chemicals shall be based on tests
performed on the chemical as presented. If, for example, for the
purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.10.3 Additional Classification Considerations
The classification procedure for pyrophoric solids need not be
applied when experience in production or handling shows that the
chemical does not ignite spontaneously on coming into contact with
air at normal temperatures (i.e. the chemical is known to be stable
at room temperature for prolonged periods of time (days)).
B.11 SELF-HEATING CHEMICALS
B.11.1 Definition
A self-heating chemical is a solid or liquid chemical, other
than a pyrophoric liquid or solid, which, by reaction with air and
without energy supply, is liable to self-heat; this chemical differs
from a pyrophoric liquid or solid in that it will ignite only when in
large amounts (kilograms) and after long periods of time (hours or days).
Note: Self-heating of a substance or mixture is a process where
the gradual reaction of that substance or mixture with oxygen (in
air) generates heat. If the rate of heat production exceeds the rate
of heat loss, then the temperature of the substance or mixture will
rise which, after an induction time, may lead to self-ignition and
combustion.
B.11.2 Classification Criteria
B.11.2.1 A self-heating chemical shall be classified in one of
the two categories for this class if, in tests performed in
accordance with test method N.4 in Part III, sub-section 33.3.1.6 of
the UN 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................................. A positive result is obtained in a
test using a 25 mm sample cube at
140 °C (284 °F).
2................................. 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 m\3\; 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 m\3\ 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
B.12.1 Definition
Chemicals which, in contact with water, emit flammable gases are
solid or liquid chemicals which, by interaction with water, are
liable to become spontaneously flammable or to give off flammable
gases in dangerous quantities.
B.12.2 Classification Criteria
B.12.2.1 A chemical which, in contact with water, emits
flammable gases shall be classified in one of the three categories
for this class, using test N.5 in Part III, sub-section 33.4.1.4 of
the UN Recommendations on the Transport of Dangerous Goods, Manual
of Tests and Criteria, Fourth Revised Edition, in accordance with
Table B.12.1:
Table B.12.1--Criteria for Chemicals Which, in Contact With Water, Emit
Flammable Gases
------------------------------------------------------------------------
Category Criteria
------------------------------------------------------------------------
1................................. Any chemical which reacts vigorously
with water at ambient temperatures
and demonstrates generally a
tendency for the gas produced to
ignite spontaneously, or which
reacts readily with water at
ambient temperatures such that the
rate of evolution of flammable gas
is equal to or greater than 10
liters per kilogram of chemical
over any one minute.
2................................. Any chemical which reacts readily
with water at ambient temperatures
such that the maximum rate of
evolution of flammable gas is equal
to or greater than 20 liters per
kilogram of chemical per hour, and
which does not meet the criteria
for Category 1.
3................................. Any chemical which reacts slowly
with water at ambient temperatures
such that the maximum rate of
evolution of flammable gas is 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.
------------------------------------------------------------------------
Note: Classification of solid chemicals shall be based on tests
performed on the chemical as presented. If, for example, for the
purposes of supply or transport, the same chemical is to be
presented in a physical form different from that which was tested
and which is considered likely to materially alter its performance
in a classification test, classification must be based on testing of
the chemical in the new form.
B.12.2.2 A chemical is classified as a chemical which, in
contact with water, emits flammable gases if spontaneous ignition
takes place in any step of the test procedure.
B.12.3 Additional Classification Considerations
The classification procedure for this class need not be applied
if:
(a) The chemical structure of the chemical does not contain
metals or metalloids;
(b) Experience in production or handling shows that the chemical
does not react with water, (e.g., the chemical is manufactured with
water or washed with water); or
(c) The chemical is known to be soluble in water to form a
stable mixture.
B.13 OXIDIZING LIQUIDS
B.13.1 Definition
Oxidizing liquid means a liquid which, while in itself not
necessarily combustible, may, generally by yielding oxygen, cause,
or contribute to, the combustion of other material.
B.13.2 Classification Criteria
An oxidizing liquid shall be classified in one of the three
categories for this class using test O.2 in Part III, sub-section
34.4.2 of the UN Recommendations on the Transport of Dangerous
Goods, Manual of Tests and 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;
2................................. Any chemical which, in the 1:1
mixture, by mass, of chemical and
cellulose tested, exhibits a mean
pressure rise time less than or
equal to the mean pressure rise
time of a 1:1 mixture, by mass, of
40% aqueous sodium chlorate
solution and cellulose; and the
criteria for Category 1 are not
met;
3................................. Any chemical which, in the 1:1
mixture, by mass, of chemical and
cellulose tested, exhibits a mean
pressure rise time less than or
equal to the mean pressure rise
time of a 1:1 mixture, by mass, of
65% aqueous nitric acid and
cellulose; and the criteria for
Categories 1 and 2 are not met.
------------------------------------------------------------------------
B.13.3 Additional Classification Considerations
B.13.3.1 For organic chemicals, the classification procedure for
this class shall not be applied if:
(a) The chemical does not contain oxygen, fluorine or chlorine;
or
(b) The chemical contains oxygen, fluorine or chlorine and these
elements are chemically bonded only to carbon or hydrogen.
B.13.3.2 For inorganic chemicals, the classification procedure
for this class shall not be applied if the chemical does not contain
oxygen or halogen atoms.
B.13.3.3 In the event of divergence between 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, sub-section 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 OXIDIZING SOLIDS
B.14.1 Definition
Oxidizing solid means a solid which, while in itself is not
necessarily combustible, may, generally by yielding oxygen, cause,
or contribute to, the combustion of other material.
B.14.2 Classification Criteria
An oxidizing solid shall be classified in one of the three
categories for this class using test O.1 in Part III, sub-section
34.4.1 of 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.
2............................. Any chemical which, in the 4:1 or 1:1
sample-to-cellulose ratio (by mass)
tested, exhibits a mean burning time
equal to or less than the mean burning
time of a 2:3 mixture (by mass) of
potassium bromate and cellulose and the
criteria for Category 1 are not met.
3............................. 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.
------------------------------------------------------------------------
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.
B.14.3 Additional Classification Considerations
B.14.3.1 For organic chemicals, the classification procedure for
this class shall not be applied if:
(a) The chemical does not contain oxygen, fluorine or chlorine;
or
(b) The chemical contains oxygen, fluorine or chlorine and these
elements are chemically bonded only to carbon or hydrogen.
B.14.3.2 For inorganic chemicals, the classification procedure
for this class shall not be applied if the chemical does not contain
oxygen or halogen atoms.
B.14.3.3 In the event of divergence between 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.15 ORGANIC PEROXIDES
B.15.1 Definition
B.15.1.1 Organic peroxide means a liquid or solid organic
chemical which contains the bivalent -0-0- structure and as such is
considered a derivative of hydrogen peroxide, where one or both of
the hydrogen atoms have been replaced by organic radicals. The term
organic peroxide includes organic peroxide mixtures containing at
least one organic peroxide. Organic peroxides are thermally unstable
chemicals, which may undergo exothermic self-accelerating
decomposition. In addition, they may have one or more of the
following properties:
(a) Be liable to explosive decomposition;
(b) Burn rapidly;
(c) Be sensitive to impact or friction;
(d) React dangerously with other substances.
B.15.1.2 An organic peroxide is regarded as possessing explosive
properties when in laboratory testing the formulation is liable to
detonate, to deflagrate rapidly or to show a violent effect when heated
under confinement.
B.15.2 Classification Criteria
B.15.2.1 Any organic peroxide shall be considered for
classification in this class, unless it contains:
(a) Not more than 1.0% available oxygen from the organic
peroxides when containing not more than 1.0% hydrogen peroxide; or
(b) Not more than 0.5% available oxygen from the organic
peroxides when containing more than 1.0% but not more than 7.0%
hydrogen peroxide.
Note: The available oxygen content (%) of an organic peroxide
mixture is given by the formula:
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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 (self-accelerating
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 °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 CORROSIVE TO METALS
B.16.1 Definition
A chemical which is corrosive to metals means a chemical which
by chemical action will materially damage, or even destroy, metals.
B.16.2 Classification Criteria
A chemical which is corrosive to metals shall be classified in a
single category for this class, using the test in Part III, sub-
section 37.4 of the UN 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.
------------------------------------------------------------------------
Note: Where an initial test on either steel or aluminium
indicates the chemical being tested is corrosive the follow-up test
on the other metal is not necessary.
B.16.3 Additional classification considerations
The specimen to be used for the test shall be made of the
following materials:
(a) For the purposes of testing steel, steel types S235JR+CR
(1.0037 resp.St 37-2), S275J2G3+CR (1.0144 resp.St 44-3), ISO 3574,
Unified Numbering System (UNS) G 10200, or SAE 1020;
(b) For the purposes of testing aluminium: non-clad types 7075-
T6 or AZ5GU-T6.
Appendix C to Sec. 1910.1200- Allocation of Label Elements (Mandatory)
C.1 The label for each hazardous chemical shall include the
product identifier used on the safety data sheet
C.1.1 The labels on shipped containers shall also include the
name, address, and telephone number of the 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;
C.2.1.3 If the corrosive pictogram is included, the exclamation
mark pictogram shall not appear where it is used for skin or eye
irritation;
C.2.1.4 If the health hazard pictogram is included for
respiratory sensitization, the exclamation mark pictogram shall not
appear where it is used for skin sensitization or for skin or eye
irritation.
C.2.2 Hazard Statement Text
C.2.2.1 The text of all applicable hazard statements shall
appear on the label, except as otherwise specified. The information
in italics shall be included as part of the hazard statement as
provided. For example: "causes damage to organs (state all organs
affected) through prolonged or repeated exposure (state route of
exposure if no other routes of exposure cause the hazard)". Hazard
statements may be combined where appropriate to reduce the
information on the label and improve readability, as long as all of
the hazards are conveyed as required.
C.2.3 Pictograms
C.2.3.1 Pictograms shall be in the shape of a square set at a
point and shall include a black hazard symbol on a white background
with a red frame sufficiently wide to be clearly visible.
C.2.3.2 One of eight standard hazard symbols shall be used in
each pictogram. The eight hazard symbols are depicted in Figure C.1.
A pictogram using the exclamation mark symbol is presented in Figure
C.2, for the purpose of illustration.
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C.2.3.3 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.
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 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 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 x 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
Appendix D to Sec. 1910.1200--Safety Data Sheets (Mandatory)
A safety data sheet (SDS) shall include the information specified
in Table D.1 under the section number and heading indicated for
sections 1-11 and 16. If no relevant information is found for any given
subheading, the SDS shall clearly indicate that no applicable
information is available. Sections 12-15 may be included in the SDS,
but are not mandatory.
Table D.1--Minimum Information for an SDS
------------------------------------------------------------------------
------------------------------------------------------------------------
1. Identification............ (a) Product identifier used on the label;
(b) Other means of identification;
(c) Recommended use of the chemical and
restrictions on use;
(d) Name, address, and telephone number
of the manufacturer, importer, or other
responsible party;
(e) Emergency phone number.
2. Hazard(s) identification.. (a) Classification of the chemical in
accordance with paragraph (d) of 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 x
percent of the mixture consists of
ingredient(s) of unknown toxicity is
required.
3. Composition/information on Except as provided for in paragraph (i)
ingredients. 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.
4. First-aid measures........ (a) Description of necessary measures,
subdivided according to the different
routes of exposure, i.e., inhalation,
skin and eye contact, and ingestion;
(b) Most important symptoms/effects,
acute and delayed.
(c) Indication of immediate medical
attention and special treatment needed,
if necessary.
5. Fire-fighting measures.... (a) Suitable (and unsuitable)
extinguishing media.
(b) Specific hazards arising from the
chemical (e.g., nature of any hazardous
combustion products).
(c) Special protective equipment and
precautions for fire-fighters.
6. Accidental release (a) Personal precautions, protective
measures. equipment, and emergency procedures.
(b) Methods and materials for containment
and cleaning up.
7. Handling and storage...... (a) Precautions for safe handling.
(b) Conditions for safe storage,
including any incompatibilities.
8. Exposure controls/personal (a) OSHA permissible exposure limit (PEL)
protection. 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.
9. Physical and chemical (a) Appearance (physical state, color,
properties. 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.
10. Stability and reactivity. (a) Reactivity;
(b) Chemical stability;
(c) Possibility of hazardous reactions;
(d) Conditions to avoid (e.g., static
discharge, shock, or vibration);
(e) Incompatible materials;
(f) Hazardous decomposition products.
11. Toxicological information Description of the various toxicological
(health) effects and the available data
used to identify those effects,
including:
(a) information on the likely routes of
exposure (inhalation, ingestion, skin
and eye contact);
(b) Symptoms related to the physical,
chemical and toxicological
characteristics;
(c) Delayed and immediate effects and
also chronic effects from short and long
term exposure;
(d) Numerical measures of toxicity (such
as acute toxicity estimates).
12. Ecological information
(Non-mandatory).
(a) Ecotoxicity (aquatic and terrestrial,
where available);
(b) Persistence and degradability;
(c) Bioaccumulative potential;
(d) Mobility in soil;
(e) Other adverse effects (such as
hazardous to the ozone layer).
13. Disposal considerations Description of waste residues and
(Non-mandatory). information on their safe handling and
methods of disposal, including the
disposal of any contaminated packaging.
14. Transport information (a) UN number;
(Non-mandatory).
(b) UN proper shipping name;
(c) Transport hazard class(es);
(d) Packing group, if applicable;
(e) Environmental hazards (e.g., Marine
pollutant (Yes/No));
(f) Transport in bulk (according to 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.
15. Regulatory information Safety, health and environmental
(Non-mandatory). regulations specific for the product in
question.
16. Other information, The date of preparation of the SDS or the
including date of last change to it.
preparation or last revision.
------------------------------------------------------------------------
* * * * *
Appendix F to Sec. 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
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 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 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 case-by-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.
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.
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.
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.
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 [alpha]2u-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.
*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.
Lehman-McKeeman, 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.
32. Amend Sec. 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:
Sec. 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.
* * * * *
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.
Subpart Z--[Amended]
34. Amend Sec. 1915.1001 to revise paragraphs (i)(3), (k)(7), and
(k)(8) to read as follows:
Sec. 1915.1001 Asbestos.
* * * * *
(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.
(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
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
AUTHORIZED PERSONNEL ONLY
(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 Sec. 1915.1026 to revise paragraphs (g)(2)(iv) and
(j)(1) to read as follows:
Sec. 1915.1026 Chromium (VI).
* * * * *
(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 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 Sec. 1926.60 to revise paragraph (j)(2)(v), (l)(1), and
(l)(2) to read as follows:
Sec. 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 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
CONTAINS METHYLENEDIANILINE (MDA)
MAY CAUSE CANCER
CAUSES DAMAGE TO THE LIVER
* * * * *
(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:
DANGER
MDA
MAY CAUSE CANCER
CAUSES DAMAGE TO THE LIVER
RESPIRATORY PROTECTION AND PROTECTIVE CLOTHING MAY BE REQUIRED IN THIS
AREA
AUTHORIZED PERSONNEL ONLY
* * * * *
38. Amend Sec. 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:
Sec. 1926.62 Lead.
* * * * *
(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:
DANGER: CLOTHING 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
* * * * *
(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 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 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 Sec. 1926.64 to revise paragraphs (a)(1)(ii)
introductory text and (a)(1)(ii)(B) to read as follows:
Sec. 1926.64 Process safety management of highly hazardous chemicals.
* * * * *
(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 Sec. 1926.65 (a)(3) to revise the definition of "Health
hazard" to read as follows:
Sec. 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 Sec. 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 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:
Sec. 1926.152 Flammable liquids.
* * * * *
(b) * * *
(2) * * *
(iii) Cabinets shall be labeled in conspicuous lettering,
"Flammable-Keep 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 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 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) * * *
(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 installed as to minimize the possibility of generating static
electricity by terminating within 6 inches (15.24 cm) of the bottom of
the tank.
* * * * *
(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 Sec. 1926.155 as follows:
A. Remove and reserve paragraph (c);
B. Revise paragraphs (h) and (i)(1) and (2).
The revisions read as follows:
Sec. 1926.155 Definitions applicable to this subpart.
* * * * *
(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:
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.
(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
(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.
45. Amend Sec. 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:
Sec. 1926.1101 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:
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:
DANGER
CONTAINS ASBESTOS FIBERS
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS
DO NOT BREATH DUST
* * * * *
46. Amend Sec. 1926.1126 to revise paragraphs (g)(2)(iv) and
(j)(1) to read as follows:
Sec. 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 Sec. 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:
Sec. 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
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]
BILLING CODE 4510-26-P
