[Federal Register Volume 74, Number 188 (Wednesday, September 30, 2009)]
[Proposed Rules]
[Pages 50280-50549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22483]



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Part II





Department of Labor





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Occupational Safety and Health Administration



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29 CFR Parts 1910, 1915, and 1926



Hazard Communication; Proposed Rule

  Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / 
Proposed Rules  

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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

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    (h) Employee Information and Training
    (i) Trade Secrets
    (j) Effective Dates
    (k) Other Standards Affected
    (l) Appendices
XVI. References
XVII. Authority and Signature
XVIII. Proposed Amendments

    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

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significant impact on a substantial number of small entities. 
Nevertheless, because of the number of small entities affected, OSHA 
has prepared a voluntary initial regulatory flexibility analysis, the 
results of which are described in Section VII of the proposed rule. Do 
you consider the estimated costs and impacts on small entities 
presented there to be reasonable? Why or why not?
    4. Are there alternatives to the rule as a whole or specific 
requirements of the rule that reduce impacts on small entities while 
still protecting the health of employees and meeting the broad goal of 
a globally harmonized system?

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?

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    14. In addition to the pictograms, signal word and hazard 
statements, GHS labels must include precautionary statements. OSHA is 
proposing to require the text in the precautionary statements in the 
GHS to be on HCS labels. As discussed in Section XV Summary and 
Explanation of the Proposed Standard, these statements are codified 
under the GHS, meaning that numbers have been assigned to them. In 
addition, the appropriate statements to use for each hazard class and 
category have been indicated in the GHS annexes. This means that label 
preparers will know exactly what precautionary statements to apply once 
they complete their hazard classification, and chemical users will see 
consistent language on labels to indicate the necessary precautionary 
measures. However, the statements are not yet considered to be part of 
the harmonized text like hazard statements are; rather they are 
included in the GHS as an suggested language. OSHA expects that other 
countries may adopt the codified precautionary statements when they put 
GHS in place. For example the EU has required that labels use the GHS 
codified precautionary statement text in adapting the GHS. Since OSHA 
did not previously require the use of precautionary statements, and had 
no such recommended statements to provide, the Agency is proposing to 
use those currently in the GHS as the mandatory requirements with the 
option of consolidating statements where appropriate (See Appendix C). 
OSHA anticipates this approach will provide the maximum benefit. OSHA 
is also seeking comment on whether any of these statements should be 
modified or if other precautionary statements should be included.
    In addition, as discussed in Section IV, OSHA has presented other 
alternatives with regards to precautionary statements, and OSHA is 
soliciting comment on these options as well. Specifically, OSHA is 
seeking feedback on whether the Agency should include the GHS 
precautionary statements as nonbinding examples, through a non 
mandatory appendix or guidance, rather than as required statements, or 
whether OSHA should allow label preparers to develop their own 
precautionary statements rather than specifying the text to be used.
    15. OSHA has not proposed to require the exploding bomb pictogram 
or specific precautionary statements for Division 1.4S ammunition and 
ammunition components because the specified GHS label elements may not 
accurately reflect the hazards of these materials. Is this sufficiently 
protective? Are any adjustments to the label elements for Division 1.4S 
ammunition and ammunition components necessary? Describe any requested 
changes and explain why such revisions are necessary.
    16. In the current HCS, OSHA has a provision that requires labels 
to be updated within three months of obtaining new and significant 
information about the hazards. The Agency has not been enforcing this 
provision for many years, and there has been an administrative stay on 
enforcement. OSHA is including the provision in this proposal, and 
inviting comment on it with the intention of including it in the final 
rule and lifting the stay. Is three months the appropriate time 
interval for updating? Are there any practical accommodations that need 
to accompany this limit (for example, related to stockpiles of 
chemicals)? Provide any alternatives you consider appropriate, as well 
as documentation to support them.

Safety Data Sheets (SDSs)

    17. As discussed in Section XV, the Agency is proposing to require 
that OSHA permissible exposure limits (PELs) be included on the SDS, as 
well as any other exposure limit used or recommended by the chemical 
manufacturer, importer, or employer preparing the safety data sheet. 
OSHA welcomes comments on this approach, along with an explanation of 
the basis for your position.
    18. OSHA is proposing that Section 15 of the SDS be non-mandatory. 
As indicated in Appendix D, Section 15 addresses regulatory information 
concerning the chemical. OSHA is considering requiring the substance 
specific standards be referenced in this section, which would make 
Section 15 mandatory. Would employers and employees benefit from having 
this information in this section of the SDS?

Other Standards Affected

    19. OSHA is proposing to align the definitions of the physical 
hazards to the requirements of the GHS categories in safety standards 
for general industry, construction, and maritime standards, which 
either directly reference the HCS or provide information pertinent to 
the Safety Data Sheets (SDSs). In most cases OSHA has modified the 
standards to maintain scope and protection. However, the changes in 
definitions for flammable liquids Category 1 and 2 and flammable 
aerosols appear to be more than simply rounding to the nearest 
significant number.
    [cir] Flammable liquids Category 1 and 2: The boiling point cut-off 
for Category 1 is reduced from 100 deg F (37.8 deg C) or less to 95 deg 
F (35 deg C) or less, which could shift some liquids from Category 1 to 
Category 2.
    [cir] Flammable aerosols: OSHA is proposing to adopt the GHS method 
to determine flammability rather than the method defined by the 
Consumer Product Safety Commission (CPSC).
    OSHA's decision to change these definitions to be consistent with 
the GHS is based not only upon harmonizing its standards with those of 
other countries that have adopted or may adopt the GHS, but OSHA is 
also concerned with making its standards internally consistent. OSHA 
believes the methods used to classify these physical hazards are 
similar enough so that substances that are currently regulated by OSHA 
would continue to be regulated and that few, if any, changes would 
result in a shift in regulatory coverage. Would the proposed changes 
have any impact on your operations? If so, describe the anticipated 
effects.
    20. OSHA is proposing to eliminate the term ``combustible liquid'' 
in 29 CFR 1910.106. 1910.107, 1910.123, 1910.124, 1910.125, and 
1926.155 for liquids with a flashpoint above 100 [deg]F. To reflect 
consistency with the revised HCS where appropriate, OSHA is proposing 
to add the specific flashpoint criteria. This will maintain equivalent 
protection. Are there other standards that OSHA should update with the 
new terminology?
    21. OSHA is proposing to modify the language required on signs in 
substance-specific health standards. The Agency developed the proposed 
language to reflect the terminology of the revised HCS while, at the 
same time, providing adequate warning through language that is 
consistent with the current sign requirements for these chemicals. An 
added benefit is the hazard warnings on signs specified for these 
standards will now be consistent throughout OSHA standards. For 
example, all carcinogens will now bear the hazard statement ``MAY CAUSE 
CANCER''. OSHA believes that providing language that is consistent on 
both signs and labels will improve comprehension for employees. Does 
the proposed language on signs accurately convey the hazards?
    22. OSHA is proposing to revise the substance-specific health 
standards' provisions on labeling for producers and importers of 
chemicals and substances. Currently in the substance-specific standards 
OSHA requires specific language on labels for certain chemicals. OSHA 
is proposing to change these labeling requirements by referring those 
responsible for labeling to the modified HCS and including in each 
substance-

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specific standard a list of health effects that must be considered for 
hazard classification. The modified HCS will dictate the specific 
language (i.e., signal word, hazard statement(s), and precautionary 
statement(s)) that is required on labels through the classification 
process. However, OSHA is proposing to maintain specific language for 
labels on contaminated clothing and waste/debris containers to ensure 
adequate hazard communication for the downstream recipients. How would 
the removal of required language for labels from substance-specific 
standards affect your work place? Are there hazard warnings that will 
be lost that do not have an equivalent hazard or precautionary 
statement? Are there alternatives to OSHA's approach for the substance-
specific standards that will assure information is disseminated in a 
manner that is consistent with the modified HCS labeling requirements?
    23. In determining the health hazards that need to be considered by 
manufacturers, importers and distributors when classifying chemicals 
regulated by the substance-specific standards, OSHA is proposing to 
primarily rely on the determinations made by the Agency in each 
rulemaking, the NIOSH Pocket Guide to Chemical Hazards (2005) and the 
International Chemical Safety Cards, and use as a secondary source the 
health effects identified by the European Commission (2007). OSHA is 
proposing to include a health hazard only if it is identified as such 
by two or more of these organizations. Are there other sources of 
information that OSHA should consult?
    24. As detailed in the Summary and Explanation section of this 
document, OSHA is not proposing in this rulemaking to update the 
electrical standards (general industry 1910 subpart S and construction 
1926 subpart K) or Explosives and blasting agents (general industry 
1910.109 and construction 1926.914). These subparts are ``self-
contained'' in that they do not rely on other OSHA standards for 
regulatory scope or definitions, but reference external organizations 
(such as the National Fire Protection Association [NFPA]). OSHA 
believes that these standards could be updated when the referenced 
external organizations adopt applicable GHS elements. If OSHA were to 
change these standards to comply with the GHS, how would this impact 
your operations?

Effective Dates

    25. OSHA has proposed to require that employers train employees 
regarding the new labels and safety data 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,

[[Page 50285]]

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

[[Page 50286]]

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,

[[Page 50287]]

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

[[Page 50288]]

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

[[Page 50289]]

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

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make modifications to the current HCS in order to improve hazard 
communication through adoption of components of the GHS. Under this 
option OSHA would add requirements for standardized hazard statements, 
signal words, and precautionary statements being added to the current 
HCS, but otherwise would follow the approach outlined in Alternative 1 
above.
    Since the standardized labels are relatively inexpensive to 
implement, while reviewing classifications is more costly, this has the 
potential to reduce the overall cost of implementation of the revised 
rule.
    A variation on this alternative would entail incorporation of some, 
but not all, of the label elements. In particular, the Agency would not 
adopt the precautionary statements since these are not yet considered 
to be ``harmonized'' under the GHS--they are provided for guidance and 
reference, but competent authorities may choose to implement other 
statements. The precautionary statements could be adopted later when 
they are harmonized under the GHS. Or, alternatively, OSHA could either 
allow label preparers to use whatever precautionary statements they 
deem appropriate or develop its own set of statements to require.
    From OSHA's perspective, a key issue regarding the alternative 
approaches presented is that the classification criteria in the GHS are 
different from the hazard definitions in the current HCS. In general, 
as discussed in Section XV, they cover the same scope of hazard so 
these differences do not result in significant differences in the 
chemicals covered. But the GHS criteria divide most of the hazard 
classes into hazard categories that convey the severity of the effect, 
while few of the hazard classes in the current HCS take this approach. 
The standardized label elements are associated with these specific 
hazard categories, i.e., the harmonized pictograms, signal words, and 
hazard statements are assigned by hazard category and reflect the 
degree of hazard it presents to those exposed. Likewise, the 
precautionary statements assigned are also reflective of the degree of 
hazard, with responses related to these presumed hazard levels.
    Additionally, with regard to the first alternative, there will be 
chemicals that will be classified in different hazards classes under 
the GHS classification scheme versus the HCS hazard determination step. 
In addition, these chemicals will also be assigned to hazard categories 
under GHS where there are none now. This is particularly true for the 
classification of mixtures for 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

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manufacturer to accomplish OSHA further solicits comment on whether 
confusion may result from labels that may look the same but which 
actually reflect different classification criteria. Under this 
approach, chemical producers will have to assess their current 
determinations and attempt to relate them to the established hazard 
classes and categories. Alternatively, OSHA could create a regulatory 
system assigning HCS categories to each GHS label elements; comments 
are welcomed on the impact on benefits and costs, and the feasibility 
of such an approach. OSHA believes it is unlikely that this component 
of Alternative 2 would provide significant savings over reviewing 
classifications for purposes of putting the chemicals into GHS classes 
and categories.
    OSHA is concerned that chemical producers following this approach 
might not be able to use their labels in other countries where the GHS 
has been adopted. OSHA is further concerned that adopting only some 
elements of the GHS label may be confusing and may fail to provide 
useful information regarding the possible hazardous effects of 
exposure. Delaying adoption of the precautionary statements may also 
reduce the effectiveness of the labels significantly, and reduce the 
appropriate information on the SDSs as well. A variation on this 
alternative--to simply require precautionary statements, but not to 
specify what they are, may generate significant variation due to the 
performance-oriented approach that allows the label preparer to 
determine what they are or if they are included. One communication 
advantage of providing the information in the same language from label-
to-label is that workers and other users can be assured that the same 
action is required. If you take a simple preventive measure such as 
``wash your hands,'' but convey it in several different ways, the 
reader of the label will think you mean something different. This is 
one of the advantages of providing the text for these statements in the 
revised HCS. In addition, since these precautionary statements will be 
translated, this should make it easier for those participating in 
international trade to produce and use labels.
    Thus, OSHA solicits comment on a range of alternative approaches to 
regulatory adoption of GHS and welcomes comments on these options. The 
costs and benefits are further addressed in Section VII.

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).

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    Further work related to comprehensibility was conducted during the 
GHS negotiations by researchers in South Africa at the University of 
Cape Town--the result is an annex to the GHS related to 
comprehensibility testing (see GHS Annex 6, Comprehensibility Testing 
Methodology) (United Nations, 2009). Such testing has been conducted in 
some of the developing countries preparing to implement the GHS, and 
has provided these countries with information about which areas in the 
GHS will require more training in their programs to ensure people 
understand the information. The primary purpose of these activities was 
to ensure that the system developed was designed in such a way that the 
messages would be effectively conveyed to the target audiences, with 
the knowledge that the system would be implemented internationally in 
different cultures with varying interests and concerns.
    Also among the agreed principles that were established to guide 
development of the GHS was that the level of protection offered by an 
existing hazard communication system should not be reduced. Following 
these principles, the best aspects of existing systems were identified 
and included in a single, harmonized approach to classification, 
labeling, and development of SDSs.
    The GHS was developed by a large group of experts representing a 
variety of perspectives. Over 200 experts provided technical input on 
the project. The United Nations Sub-Committee of Experts on the GHS, 
the body that formally adopted the GHS and is now responsible for its 
maintenance, includes 32 member nations as well as 17 observer nations. 
Authorities from these member states are able to convey the insight and 
understanding acquired by regulatory authorities in different sectors, 
and to relate their own experiences in implementation of hazard 
communication requirements. In addition, over two dozen international 
and intergovernmental organizations, trade associations, and unions are 
represented, and their expertise serves to inform the member nations. 
The GHS consequently represents a consensus recommendation of experts 
with regard to best practices for effective chemical hazard 
communication, reflecting the collective knowledge and experience of 
regulatory authorities in many nations and in different regulatory 
sectors, as well as other organizations that have expertise in this 
area. A number of United States-based scientific and professional 
associations have endorsed adoption of the GHS. The American Chemical 
Society indicated its support 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.

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Labels
    Labels provide a brief, conspicuous hazard summary at the work site 
where a chemical is used. Labels serve as an immediate visual reminder 
of chemical hazards, and complement the information presented in 
training and on SDSs.
    The HCS currently requires that labels on hazardous chemical 
containers include the identity of the hazardous chemical; appropriate 
hazard warnings that convey the specific physical and health hazards, 
including target organ effects; and the name and address of the 
chemical manufacturer, importer, or other responsible party. The HCS 
does not specify a standard format or design elements for labels.
    OSHA is proposing a requirement that labels include four new, 
standardized elements: a signal word; hazard statement(s); 
pictogram(s); and precautionary statement(s) (see Section XV for a 
detailed discussion of the proposed requirements). The appropriate 
label elements for a chemical would be determined by the hazard 
classification. OSHA believes that these standardized label elements 
would better convey critically important hazard warnings, and provide 
useful information regarding precautionary measures that would serve to 
better protect employees.
    A great deal of literature has been developed that examines the 
effectiveness of warnings on labels. However, some important 
limitations must be recognized in applying this information to 
workplace labels for hazardous chemical products. Most studies have 
examined labels for prescription and non-prescription medications, 
alcoholic beverages, or consumer products. Relatively few studies 
pertain specifically to labels for hazardous chemicals in the 
workplace. Much of the literature is also characterized by the use of 
research subjects such as college students or consumers. Such subjects 
may not be representative of workplace populations, as these subjects 
may differ from typical employees in terms of product knowledge, hazard 
perception, perceptual abilities, and safety motivation. In addition, 
some studies involve non-U.S. populations that may not be 
representative of the U.S. workforce.
    Nevertheless, the literature provides a substantial body of 
information applicable to workplace chemical labels. In spite of the 
differences in affected populations, workplace chemical labels have 
many characteristics that are comparable to those found in other 
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

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term NOTICE (Griffith and Leonard, 1997). From most to least 
meaningful, these terms were reported to be DANGER, URGENT, BEWARE, 
WARNING, STOP, CAUTION, and IMPORTANT.
    Wogalter et al. asked over 100 undergraduates and community 
volunteers to rank signal words (Wogalter et al., 1998). DEADLY was 
perceived as most hazardous, followed by DANGER, WARNING, and CAUTION. 
All differences were statistically significant. In a follow-up 
experiment using labels produced in the ANSI Z535.2 (American National 
Standard for Environmental and Facility Safety Signs), ANSI Z535.4 
(American National Standard for Product Safety Signs and Labels), and 
alternative formats, the authors found a similar rank order for signal 
words with all labeling systems. Finally, the authors tested the same 
terms on employees from manufacturing and assembly plants and found the 
same general order: DEADLY, then DANGER, then WARNING and CAUTION with 
no significant difference between the last two terms.
    In more of a free-form experiment, Young asked 30 subjects to 
produce warning signs for a set of scenarios, using different sign 
components available on a computer screen (Young, 1998). In roughly 80 
percent of the signs, the participant chose to use a signal word. 
DANGER, DEADLY, and LETHAL were more likely to be used for scenarios 
with severe hazards; CAUTION and NOTICE for non-severe scenarios. 
WARNING was used equally in both types of scenarios. The author 
suggests that these results support a two-tiered system of signal 
words. In a separate task, users ranked the perceived hazard of signal 
words, resulting in the following list from most to least severe: 
DEADLY, LETHAL, DANGER, WARNING, CAUTION, and NOTICE.
    While these studies have focused on the relative perceptions of 
signal words, others have sought to evaluate how the absolute meaning 
of common signal words is perceived. Drake et al. asked a group of 
students and community volunteers to match signal words with 
definitions borrowed from consensus standards and other sources (Drake 
et al., 1998). Participants matched DANGER to a correct definition 64 
percent of the time, while NOTICE was matched correctly 68 percent of 
the time. WARNING and CAUTION were matched correctly less than half of 
the time, suggesting confusion. The authors recommended using WARNING 
and CAUTION interchangeably. The authors 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

[[Page 50295]]

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.''

[[Page 50296]]

    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:
    [dec221] 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.
    [dec221] 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).
    [dec221] 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.
    [dec221] 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.
    [dec221] 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.
    [dec221] 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).
    [dec221] Banda and Sichilongo asked workers in Zambia to rate the 
perceived hazard of various colors used in chemical labels (Banda and 
Sichilongo,

[[Page 50297]]

2006). Red was associated with the greatest hazard, followed by yellow.
    [dec221] 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

[[Page 50298]]

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

[[Page 50299]]

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

[[Page 50300]]

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

[[Page 50301]]

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/

[[Page 50302]]

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

[[Page 50303]]

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

[[Page 50304]]

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,

[[Page 50305]]

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

[[Page 50306]]

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,

[[Page 50307]]

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,

[[Page 50308]]

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

[[Page 50309]]

[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

[[Page 50310]]

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

[[Page 50311]]

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

    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

[[Page 50312]]

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

[[Page 50321]]

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\
---------------------------------------------------------------------------

    \5\ http://data.bls.gov/cgi-bin/cpicalc.pl. BLS inflation 
calculator used on September 23, 2008.
---------------------------------------------------------------------------

    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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[[Page 50322]]

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

    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

[[Page 50323]]

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

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.

[[Page 50324]]

    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

[[Page 50333]]

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

[[Page 50334]]

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

[[Page 50335]]

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

[[Page 50336]]

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\
---------------------------------------------------------------------------

    \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.
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    OSHA requests additional comments and information from affected 
establishments and from the public regarding the nature of the 
incremental management familiarization costs associated with the 
proposed revisions.
Costs Associated With Training Employees
    Production employees who are currently covered by and trained under 
the provisions of the existing HCS would need to receive some 
additional training to become familiar with the proposed changes to 
SDSs and labels.
    In many potentially affected establishments that do not produce 
SDSs, and that have few affected chemicals or few affected employees, a 
very basic hazard communication program may achieve compliance with the 
OSHA standard. In these establishments, the incremental employee 
training costs associated with the proposed revisions to the OSHA 
standard may be relatively small. In other cases, employers may be able 
to integrate the necessary training into existing training programs and 
other methods of distributing safety and health information to 
employees, and thus may not incur much additional cost. Nevertheless, 
in order to adequately reflect the opportunity costs of devoting time 
and resources to the necessary training, and in order to ensure that 
the estimated compliance costs reflect an adequate emphasis on the 
familiarization with the proposed new hazard communication system, a 
more substantial training cost was estimated.
    An estimated 30 minutes of training, in addition to training that 
would otherwise be received, would provide adequate time for employees 
to become familiar with the new system. For some occupations for which 
the use of hazardous chemicals is minimal and the number of hazards for 
which training is needed is small, OSHA estimated that 15 minutes of 
training would be sufficient. For some occupations in the 
transportation sector, where GHS pictograms are already in use, OSHA 
estimated that only 5 minutes of training would be needed. A complete 
occupation-by-occupation review of OSHA's estimates is provided in the 
PP&E report.

[[Page 50337]]

    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\
---------------------------------------------------------------------------

    \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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BILLING CODE 4510-26-C

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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BILLING CODE 4510-26-C
    In profit-earning entities, compliance costs can generally be 
expected to be absorbed through a combination of increases in prices or 
reduction in

[[Page 50355]]

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

[[Page 50356]]

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

[[Page 50363]]

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

[[Page 50370]]

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

[[Page 50371]]

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.

[[Page 50372]]

    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

[[Page 50373]]

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,

[[Page 50374]]

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

[[Page 50375]]

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

[[Page 50376]]

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.
BILLING CODE 4510-26-P

[[Page 50377]]

[GRAPHIC] [TIFF OMITTED] TP30SE09.045

BILLING CODE 4510-26-C
    In a second sensitivity test, when OSHA increased the estimated 
total number of affected SDSs addressed by this rulemaking by 50 
percent, the

[[Page 50378]]

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\
---------------------------------------------------------------------------

    \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

[[Page 50379]]

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:
    [cir] Whether the proposed collection of information requirements 
are necessary for the proper performance of the Agency's functions, 
including whether the information is useful;
    [cir] 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;
    [cir] The quality, utility, and clarity of the information 
collected; and
    [cir] 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.

[[Page 50380]]

    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

[[Page 50381]]

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

[[Page 50382]]

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

[[Page 50383]]

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

[[Page 50384]]

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,

[[Page 50385]]

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

[[Page 50386]]

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

[[Page 50387]]

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

[[Page 50388]]

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

[[Page 50389]]

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

[[Page 50390]]

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).

[[Page 50391]]

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

[[Page 50392]]

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

[[Page 50393]]

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

[[Page 50394]]

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

[[Page 50395]]

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

[[Page 50396]]

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,

[[Page 50397]]

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

[[Page 50398]]

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

[[Page 50399]]

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

[[Page 50400]]

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

[[Page 50401]]

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

[[Page 50402]]

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

[[Page 50403]]

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

[[Page 50404]]

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

[[Page 50405]]

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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BILLING CODE 4510-26-C
    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

[[Page 50411]]

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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BILLING CODE 4510-26-C
    In addition, OSHA has determined that the hazard and precautionary 
statements that address creating dust in the substance-specific health 
standards

[[Page 50415]]

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 [deg]F. However, the proposal incorporates the GHS 
definitions for physical hazards and defines flammable liquids as 
liquids with a flashpoint below 199.4 [deg]F, potentially increasing 
the coverage of PSM by adding flammable liquids with flashpoints 
between 100 [deg]F and 199.4 [deg]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 [deg]F (37.8 [deg]C) on site in one location, in a 
quantity of 10,000 pounds (4535.9 kg) * * *


[[Page 50416]]


    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 [deg] C to 23 [deg]C and 93.3 [deg]C to 93 [deg]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 [deg]C to a cut-point of 35 
[deg]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 
[deg]C and a BP of less than (<) 37.8 [deg]C; the new definition will 
adopt a BP of less than or equal to (<=) 35 [deg] C. Likewise, the BP 
will shift for the current definition of Flammable Class IB from equal 
to or greater than (>=) 37.8 [deg]C to (>) 35 [deg]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 [deg]C and 35 [deg]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 [deg]C, all current handling and 
storage would be permitted. In addition, storage and handling of 
chemicals whose boiling points fall between 37.8 [deg]C and 35 [deg]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.

[[Page 50417]]

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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 [deg]C will be called ``Flammable Liquids with a 
Flashpoint of > 93 [deg]C.'' The GHS does not classify flammable 
liquids with flashpoints > 93 [deg]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 [deg]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[deg]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

[[Page 50418]]

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.

XVI. References

Abt Associates, Inc., 1999. Consumer labeling initiative: Phase II 
report. U.S. Environmental Protection Agency.
Adams, A., S. Bochner, and L. Bilik, 1998. The effectiveness of 
warning signs in hazardous work places: Cognitive and social 
determinants. Applied Ergonomics 29(4): 247-254.
Akerboom, S. and M. Trommelen, 1998. Environmental labeling on 
household chemicals: Comprehensibility and impact on warning 
information. International Journal of Cognitive Ergonomics 2(1-2): 
107-122.
[ANSI] American National Standards Institute, 2002a. American 
National Standard Criteria for Safety Symbols. ANSI Z535.3-2002.
[ANSI] American National Standards Institute, 2002b. American 
National Standard for Environmental and Facility Safety Signs. ANSI 
Z535.2-2002.
[ANSI] American National Standards Institute, 2002c. American 
National Standard for Product Safety Signs and Labels. ANSI Z535.4-
2002.
[ANSI] American National Standard Institute, 2004. American National 
Standard for Hazardous Industrial Chemicals--Material Safety Data 
Sheets--Preparation. ANSI Z400.1-2004.
[ANSI] American National Standard Institute, 2006. American National 
Standard for Hazardous Industrial Chemicals--Precautionary Labeling. 
ANSI Z129.1-2006.
Banda, S.F. and K. Sichilongo, 2006. Analysis of the level of 
comprehension of chemical hazard labels: A case for Zambia. Science 
of the Total Environment 363(1-3): 22-27.
Beach, J., 2002. The problem with material safety data sheets. 
Occupational Medicine (London) 52(2): 67-68.
[BLS] U.S. Bureau of Labor Statistics. 2008. Nonfatal occupational 
illnesses by major industry sector and category of illness, private 
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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

[[Page 50421]]

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 [deg]K (176 [deg]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[deg]K (140[deg]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 [deg]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 
[deg]F (37.8 [deg]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 [deg]F (93 [deg]C). Flammable liquids are divided into four 
categories as follows:
    (i) Category 1 shall include liquids having flashpoints below 73.4 
[deg]F (23 [deg]C) and having a boiling point at or below 95 [deg]F (35 
[deg]C).
    (ii) Category 2 shall include liquids having flashpoints below 73.4 
[deg]F (23 [deg]C) and having a boiling point above 95 [deg]F (35 
[deg]C).
    (iii) Category 3 shall include liquids having flashpoints at or 
above 73.4 [deg]F (23 [deg]C) and at or below 140 [deg]F (60 [deg]C). 
When a Category 3 liquid with a flashpoint at or above 100 [deg]F (37.8 
[deg]C) is heated for use to within 30 [deg]F (16.7 [deg]C) of its 
flashpoint, it shall be handled in accordance with the requirements for 
a Category 3 liquid with a flashpoint below 100 [deg]F (37.8 [deg]C).
    (iv) Category 4 shall include liquids having flashpoints above 140 
[deg]F (60 [deg]C) and at or below 199.4 [deg]F (93 [deg]C). When a 
Category 4 flammable liquid is heated

[[Page 50422]]

for use to within 30 [deg]F (16.7 [deg]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 [deg]F (37.8 [deg]C).
    (v) When liquid with a flashpoint greater than 199.4 [deg]F (93 
[deg]C) is heated for use to within 30 [deg]F (16.7 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]C). Vent pipes from tanks storing Category 1 or 2 
flammable liquids, or Category 3 flammable liquids with a flashpoint 
below 100 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C) or 
Category 4 flammable liquids. Vent pipes from tanks storing Category 3 
flammable liquids with a flashpoint at or above 100 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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
* * * * *

[[Page 50423]]

    (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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C), 
and 15 feet for Category 3 flammable liquids with a flashpoint at or 
above 100 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C). Category 1 or 
2 flammable liquids, or Category 3 flammable liquids with a flashpoint 
below 100 [deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]C) and Category 4 flammable liquids. Category 3 
flammable liquids with a flashpoint at or above 100 [deg]F (37.8 
[deg]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

[[Page 50424]]

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 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]C), and 15 feet for Category 3 flammable liquids with a flashpoint 
at or above 100 [deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C), are 
loaded, or
    (2) Where Category 3 flammable liquids with a flashpoint at or 
above 100 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C).
* * * * *
    (d) * * *
    (2) Where no Category 1 or 2 flammable liquids, or Category 3 
flammable liquids with a flashpoint below 100 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]C), are stored or 
handled. For areas where Category 3 flammable liquids with a flashpoint 
at or above 100 [deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]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

[[Page 50425]]

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 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F 
(37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C).
* * * * *
    (4) * * *
    (iii) * * *
    (a) * * *
* * * * *
    (d) Piping handling Category 1 or 2 flammable liquids, or Category 
3 flammable liquids with a flashpoint below 100 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C), are stored or handled. For 
areas where Category 3 flammable liquids with a flashpoint at or above 
100 [deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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

[[Page 50426]]

[deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C), and 15 feet for 
Category 3 flammable liquids with a flashpoint at or above 100 [deg]F 
(37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (93 [deg]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

[[Page 50427]]

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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 [deg]F (93 [deg]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 [deg]F (93 [deg]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 [deg]F (93 [deg]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 [deg]F (93 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]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

[[Page 50433]]

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 
[deg]F. (93 [deg]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 [deg]F (93 [deg]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
 [deg]F (93 [deg]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).

[[Page 50434]]

    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:

[[Page 50435]]

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

[[Page 50436]]

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.

[[Page 50437]]

    (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.

[[Page 50438]]

    (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:

[[Page 50439]]

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.
* * * * *

[[Page 50440]]

    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

[[Page 50441]]

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.


[[Page 50442]]


    (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

[[Page 50443]]

[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.

[[Page 50444]]

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.
BILLING CODE 4510-26-P

[[Page 50445]]

[GRAPHIC] [TIFF OMITTED] TP30SE09.061

BILLING CODE 4510-26-C
    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

[[Page 50446]]

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:
[GRAPHIC] [TIFF OMITTED] TP30SE09.062

    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

[[Page 50447]]

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:
[GRAPHIC] [TIFF OMITTED] TP30SE09.139

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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BILLNG CODE 4510-26-C

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


[[Page 50451]]

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.
BILLING CODE 4510-26-P
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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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[[Page 50452]]


BILLING CODE 4510-26-C
    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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BILLING CODE 4510-26-C

A.3.4 Classification Criteria for Mixtures

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

    A.3.4.1.1 The mixture will be classified using the criteria for 
substances, and taking into account the 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%.

[[Page 50456]]

 
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);

[[Page 50457]]

    (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:

[[Page 50458]]



          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%.

[[Page 50459]]

 
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.

[[Page 50461]]



  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;

[[Page 50463]]

    (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,

[[Page 50465]]

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

[[Page 50466]]

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.

[[Page 50467]]



     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;

[[Page 50469]]

    (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;

[[Page 50470]]

    (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,

[[Page 50471]]

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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BILLING CODE 4510-26-C
    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

[[Page 50472]]

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


[[Page 50473]]

    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:

[[Page 50474]]

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    A.10.1.5.2 Although the definition of aspiration in A.10.1.1 
includes the entry of solids into the respiratory system, 
classification according to (b) in table A.10.1 for Category 1 is 
intended to apply to liquid substances and mixtures only.

A.10.1.5.3 Classification of Aerosol/Mist Products

    Aerosol and mist products are usually dispensed in containers 
such as self-pressurized containers, trigger and pump sprayers. 
Classification for these products shall be considered if their use 
may form a pool of product in the mouth, which then may be 
aspirated. If the mist or aerosol from a pressurized container is 
fine, a pool may not be formed. On the other hand, if a pressurized 
container dispenses product in a stream, a pool may be formed that 
may then be aspirated. Usually, the mist produced by trigger and 
pump sprayers is coarse and therefore, a pool may be formed that 
then may be aspirated. When the pump mechanism may be removed and 
contents are available to be swallowed then the classification of 
the products should be considered.

A.10.2 Classification Criteria for Substances

             Table A.10.1--Criteria for Aspiration Toxicity
------------------------------------------------------------------------
             Category                             Criteria
------------------------------------------------------------------------
Category 1: Chemicals known to      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 [deg]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 [deg]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 [deg]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.

[[Page 50475]]

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[deg]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[deg]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[deg]C
                                        (68[deg]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[deg]C
                                        (68[deg]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

[[Page 50476]]

 
                                   (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 [deg]C (-58
                                     [deg]F); including all gases with a
                                     critical temperature \1\ <= -50
                                     [deg]C (-58 [deg]F).
Liquefied gas.....................  A gas which when under pressure is
                                     partially liquid at temperatures
                                     above -50 [deg]C (-58 [deg]F). A
                                     distinction is made between:
                                       (a) High pressure liquefied gas:
                                        a gas with a critical
                                        temperature\1\ between -50
                                        [deg]C (-58 [deg]F) and +65
                                        [deg]C (149 [deg]F); and
                                       (b) Low pressure liquefied gas: a
                                        gas with a critical temperature
                                        \1\ above +65 [deg]C (149
                                        [deg]F).
Refrigerated liquefied gas........  A gas which is made partially liquid
                                     because of its low temperature.
Dissolved gas.....................  A gas which when under pressure is
                                     dissolved in a liquid phase
                                     solvent.
------------------------------------------------------------------------
(1) The critical temperature is the temperature above which a pure gas
  cannot be liquefied, regardless of the degree of compression.


[[Page 50477]]

B.6 FLAMMABLE LIQUIDS

B.6.1 Definition

    Flammable liquid means a liquid having a flash point of not more 
than 93 [deg]C (199.4 [deg]F).

B.6.2 Classification Criteria

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

               Table B.6.1--Criteria for Flammable Liquids
------------------------------------------------------------------------
             Category                             Criteria
------------------------------------------------------------------------
1.................................  Flash point <23 [deg]C (73.4 [deg]F)
                                     and initial boiling point <= 35
                                     [deg]C (95 [deg]F).
2.................................  Flash point <23 [deg]C (73.4 [deg]F)
                                     and initial boiling point > 35
                                     [deg]C (95 [deg]F).
3.................................  Flash point >= 23 [deg]C (73.4
                                     [deg]F) and <= 60 [deg]C (140
                                     [deg]F).
4.................................  Flash point > 60 [deg]C (140 [deg]F)
                                     and <= 93 [deg]C (199.4 [deg]F).
------------------------------------------------------------------------

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 [deg]C (167 [deg]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.

[[Page 50478]]

    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 [deg]C (140 [deg]F) to 75 [deg]C 
(167 [deg]F) for a 50 kg package), and, for liquid mixtures, a 
diluent having a boiling point greater than or equal to 150 [deg]C 
(302 [deg]F) is used for desensitization will be defined as self-
reactive chemical TYPE G. If the mixture is not thermally stable or 
a diluent having a boiling point less than 150[deg]C (302[deg]F) is 
used for desensitization, the mixture shall be defined as self-
reactive chemical TYPE F.

B.8.3 Additional Classification Considerations

    B.8.3.1 For purposes of classification, the properties of self-
reactive chemicals shall be determined in accordance with test 
series A to H as described in Part II of the UN 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[deg]C 
(167[deg]F) or the exothermic decomposition energy is less than 300 
J/g. The onset temperature and decomposition energy may be estimated 
using a suitable calorimetric technique (see 20.3.3.3 in Part II of 
the UN 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;

[[Page 50479]]

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 [deg]C (284 [deg]F).
2.................................  A negative result is obtained in a
                                     test using a 25 mm cube sample at
                                     140 [deg]C (284 [deg]F), a positive
                                     result is obtained in a test using
                                     a 100 mm sample cube at 140 [deg]C
                                     (284 [deg]F), and:
                                       (a) the unit volume of the
                                        chemical is more than 3 m\3\; or
                                       (b) a positive result is obtained
                                        in a test using a 100 mm cube
                                        sample at 120 [deg]C (248
                                        [deg]F) and the unit volume of
                                        the chemical is more than 450
                                        liters; or
                                       (c) a positive result is obtained
                                        in a test using a 100 mm cube
                                        sample at 100 [deg]C (212
                                        [deg]F).
------------------------------------------------------------------------

    B.11.2.2 Chemicals with a temperature of spontaneous combustion 
higher than 50 [deg]C (122 [deg]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 [deg]C (122 [deg]F) for a volume of 450 liters shall 
not be classified in Category 1 of this class.

B.11.3 Additional Classification Considerations

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

B.12 CHEMICALS WHICH, IN CONTACT WITH WATER, EMIT FLAMMABLE GASES

B.12.1 Definition

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

B.12.2 Classification Criteria

    B.12.2.1 A chemical which, in contact with water, emits 
flammable gases shall be classified in one of the three categories 
for this class, using test N.5 in Part III, sub-section 33.4.1.4 of 
the UN 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

[[Page 50480]]

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

[[Page 50481]]

violent effect when heated under confinement.

B.15.2 Classification Criteria

    B.15.2.1 Any organic peroxide shall be considered for 
classification in this class, unless it contains:
    (a) Not more than 1.0% available oxygen from the organic 
peroxides when containing not more than 1.0% hydrogen peroxide; or
    (b) Not more than 0.5% available oxygen from the organic 
peroxides when containing more than 1.0% but not more than 7.0% 
hydrogen peroxide.

    Note: The available oxygen content (%) of an organic peroxide 
mixture is given by the formula:

[GRAPHIC] [TIFF OMITTED] TP30SE09.142

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 [deg]C (140 [deg]F) or higher for a 
50 kg package), and, for liquid mixtures, a diluent having a boiling 
point of not less than 150 [deg]C (302 [deg]F) is used for 
desensitization, shall be defined as organic peroxide TYPE G. If the 
organic peroxide is not thermally stable or a diluent having a 
boiling point less than 150 [deg]C (302 [deg]F) is used for 
desensitization, it shall be defined as organic peroxide TYPE F.

B.15.3 Additional Classification Considerations

    B.15.3.1 For purposes of classification, the properties of 
organic peroxides shall be determined in accordance with test series 
A to H as described in Part II of the UN 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 [deg]C (131 [deg]F) when
                                     tested on both materials.
------------------------------------------------------------------------


    Note: Where an initial test on either steel or aluminium 
indicates the chemical being tested is corrosive the follow-up test 
on the other metal is not necessary.

B.16.3 Additional classification considerations

    The specimen to be used for the test shall be made of the 
following materials:
    (a) For the purposes of testing steel, steel types S235JR+CR 
(1.0037 resp.St 37-2), S275J2G3+CR (1.0144 resp.St 44-3), ISO 3574, 
Unified Numbering System (UNS) G 10200, or SAE 1020;
    (b) For the purposes of testing aluminium: non-clad types 7075-
T6 or AZ5GU-T6.

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.

[[Page 50482]]

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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BILLING CODE 4510-26-C
    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.
BILLING CODE 4510-26-P

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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);

[[Page 50541]]

 
                               (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.

[[Page 50542]]

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[deg] 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[deg] 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.
* * * * *

[[Page 50543]]

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

[[Page 50544]]

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 [deg]F (37.8 [deg]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 [deg]F (37.8 
[deg]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

[[Page 50545]]

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 [deg]F (93 
[deg]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 [deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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 
[deg]F (37.8 [deg]C). Vent pipes from tanks storing Category 1 or 2 
flammable liquids, or Category 3 flammable liquids with a flashpoint 
below 100 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]C) or 
Category 4 flammable liquids. Vent pipes from tanks storing Category 3 
with a flashpoint at or above 100 [deg]F (37.8 [deg]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 [deg]F (37.8 [deg]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) * * *

[[Page 50546]]

    (iv) * * *
    (E) For Category 2 flammable liquids or Category 3 flammable 
liquids with a flashpoint below 100 [deg]F (37.8 [deg]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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BILLING CODE 4510-26-C
* * * * *
    (iv) Piping handling Category 1 or 2 flammable liquids, or Category 
3 flammable liquids with a flashpoint below 100 [deg]F (37.8 [deg]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 [deg]F and having 
a flashpoint at or below 199.4 [deg]F (93 [deg]C). Flammable liquids 
are divided into four categories as follows:
    Category 1 shall include liquids having flashpoints below 73.4 
[deg]F (23 [deg]C) and having a boiling point at or below 95 [deg]F (35 
[deg]C).
    Category 2 shall include liquids having flashpoints below 73.4 
[deg]F (23 [deg]C) and having a boiling point above 95 [deg]F (35 
[deg]C).
    Category 3 shall include liquids having flashpoints at or above 
73.4 [deg]F (23 [deg]C) and at or below 140 [deg]F (60 [deg]C).
    Category 4 shall include liquids having flashpoints above 140 
[deg]F (60 [deg]C) and at or below 199.4 [deg]F (93 [deg]C).
    (i) * * *
    (1) The flashpoint of liquids having a viscosity less than 45 
Saybolt Universal Second(s) at 100 [deg]F (37.8 [deg]C) and a 
flashpoint below 175 [deg]F (79.4 [deg]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 [deg]F (79.4 [deg]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

[[Page 50549]]

(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