[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Rules and Regulations]
[Pages 17574-17896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4826]



[[Page 17573]]

Vol. 77

Monday,

No. 58

March 26, 2012

Part II





Department of Labor





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Occupational Safety and Health Administration





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29 CFR 1910, 1915 and 1926





Hazard Communication; Final Rule

  Federal Register / Vol. 77 , No. 58 / Monday, March 26, 2012 / Rules 
and Regulations  

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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), DOL.

ACTION: Final rule.

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SUMMARY: In this final rule, OSHA is modifying its Hazard Communication 
Standard (HCS) to conform to the United Nations' Globally Harmonized 
System of Classification and Labelling of Chemicals (GHS). OSHA has 
determined that the modifications will significantly reduce costs and 
burdens while also improving the quality and consistency of information 
provided to employers and employees regarding chemical hazards and 
associated protective measures. Consistent with the requirements of 
Executive Order 13563, which calls for assessment and, where 
appropriate, modification and improvement of existing rules, the Agency 
has concluded 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 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, and requirements for employee training on labels and 
safety data sheets. OSHA is also modifying provisions 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. 
The consequences of these modifications will be to improve safety, to 
facilitate global harmonization of standards, and to produce hundreds 
of millions of dollars in annual savings.

DATES: This final rule becomes effective on May 25, 2012 Affected 
parties do not need to comply with the information collection 
requirements in the final rule until the Department of Labor publishes 
in the Federal Register the control numbers assigned by the Office of 
Management and Budget (OMB). Publication of the control numbers 
notifies the public that OMB has approved these information collection 
requirements under the Paperwork Reduction Act of 1995.
    The incorporation by reference of the specific publications listed 
in this final rule is approved by the Director of the Federal Register 
as of May 25, 2012.

ADDRESSES: In compliance with 28 U.S.C. 2112(a), the Agency designates 
Joseph M. Woodward, Associate Solicitor for Occupational Safety and 
Health, Office of the Solicitor, Room S-4004, U.S. Department of Labor; 
200 Constitution Avenue NW., Washington, DC 20210, as the recipient of 
petitions for review of this final standard.

FOR FURTHER INFORMATION CONTACT: For general information and press 
inquiries, contact: Frank Meilinger, OSHA Office of Communications, 
Room N-3647, U.S. Department of Labor, 200 Constitution Avenue NW., 
Washington, DC 20210, telephone (202) 693-1999. For technical 
information, contact: Dorothy Dougherty, Director, 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: This final rule modifies the Hazard 
Communication standard (HCS) and aligns it with the Globally Harmonized 
System of Classification and Labelling of Chemicals (GHS) as 
established by the United Nations (UN). This action is consistent with 
Executive Order 13563 and, in particular, with its requirement of 
``retrospective analysis of rules that may be outmoded, ineffective, 
insufficient, or excessively burdensome.'' The preamble to the final 
rule provides a synopsis of the events leading up to the establishment 
of the final rule, a detailed description of OSHA's rationale for the 
necessity of the modification, and final economic and voluntary 
flexibility analyses that support the Agency's determinations. Also 
included are explanations of the specific provisions that are modified 
in the HCS and other affected OSHA standards and OSHA's responses to 
comments, testimony, and data submitted during the rulemaking. The 
discussion follows this outline:

I. Introduction
II. Events Leading to the Revised Hazard Communication Standard
III. Overview of the Final Rule and Alternatives Considered
IV. Need and Support for the Revised Hazard Communication Standard
V. Pertinent Legal Authority
VI. Final Economic Analysis and Voluntary Regulatory Flexibility 
Analysis
VII. OMB Review Under the Paperwork Reduction Act of 1995
VIII. Federalism and Consultation and Coordination With Indian 
Tribal Governments
IX. State Plans
X. Unfunded Mandates
XI. Protecting Children From Environmental Health and Safety Risks
XII. Environmental Impacts
XIII. Summary and Explanation of the Modifications to the Hazard 
Communication Standard
    (a) Purpose
    (b) Scope
    (c) Definitions
    (d) Hazard Classification
    (e) Written Hazard Communication Program
    (f) Labels and Other Forms of Warning
    (g) Safety Data Sheets
    (h) Employee Information and Training
    (i) Trade Secrets
    (j) Effective Dates
    (k) Other Standards Affected
    (l) Appendices
XIV. Authority and Signature

    The HCS requires that chemical manufacturers and importers evaluate 
the chemicals they produce or import and provide hazard information to 
downstream employers and employees by putting labels on containers and 
preparing safety data sheets. This final rule modifies the current HCS 
to align with the provisions of the UN's GHS. The modifications to the 
HCS will significantly reduce burdens and costs, and also improve the 
quality and consistency of information provided to employers and 
employees regarding chemical hazards by providing harmonized criteria 
for classifying and labeling hazardous chemicals and for preparing 
safety data sheets for these chemicals.
    OSHA is required by the Occupational Safety and Health (OSH) Act of 
1970 to assure, as far as possible, safe and healthful working 
conditions for all working men and women. Section 3(8) of the OSH Act 
(29 U.S.C. 652(8)) empowers the Secretary of Labor to promulgate 
standards that are ``reasonably necessary or appropriate to provide 
safe or healthful employment and places of employment.'' This language 
has been interpreted by the Supreme Court to require that an OSHA 
standard address a significant risk and reduce this risk significantly. 
See Industrial Union Dep't v. American Petroleum Institute, 448 U.S. 
607 (1980). As discussed in Sections IV and V of this preamble, OSHA 
finds that inadequate communication to

[[Page 17575]]

employees regarding the hazards of chemicals constitutes a significant 
risk of harm and estimates that the final rule will reduce this risk 
significantly.
    Section 6(b)(7) of the Act (29 U.S.C. 655(b)(7)) allows OSHA to 
make appropriate modifications to its hazard communication requirements 
as new knowledge and techniques are developed. The GHS system is a new 
approach that has been developed through international negotiations and 
embodies the knowledge gained in the field of chemical hazard 
communication since the current rule was first adopted in 1983. As 
indicated in Section IV of this preamble, OSHA finds that modifying the 
HCS to align with the GHS will enhance worker protections 
significantly. As noted in Section VI of this preamble, these 
modifications to HCS will also result in less expensive chemical hazard 
management and communication. In this way, the modifications are in 
line with the requirements of Executive Order 13563 and its call for 
streamlining of regulatory burdens.
    OSHA is also required to determine if its standards are 
technologically and economically feasible. As discussed in Section VI 
of this preamble, OSHA has determined that this final standard is 
technologically and economically feasible.
    The Regulatory Flexibility Act, as amended by the Small Business 
Regulatory Enforcement Fairness Act (SBREFA), requires OSHA to 
determine if a regulation will have a significant impact on a 
substantial number of small entities. As discussed in Section VI, OSHA 
has determined and certified that this rule will not have a significant 
impact on a substantial number of small entities.
    Executive Orders 13563 and 12866 require OSHA to assess the 
benefits and costs of final rules and of available regulatory 
alternatives. Executive Order 13563 emphasizes the importance of 
quantifying both costs and benefits, reducing costs, harmonizing rules, 
and promoting flexibility. This rule has been designated an 
economically significant regulatory action under section 3(f)(1) of 
Executive Order 12866. Accordingly, the rule has been reviewed by the 
Office of Management and Budget, and the remainder of this section 
summarizes the key findings of the analysis with respect to the costs 
and benefits of the final rule.
    Because this final rule modifies the current HCS to align with the 
provisions of the UN's GHS, the available alternatives to the final 
rule are somewhat limited. The Agency has qualitatively discussed the 
two major alternatives to the proposed rule--(1) voluntary adoption of 
GHS within the existing HCS framework and (2) a limited adoption of 
specific GHS components--in Section III of this preamble, but 
quantitative estimates of the costs and benefits of these alternatives 
could not reasonably be developed. However, OSHA has determined that 
both of these alternatives would eliminate significant portions of the 
benefits of the rule, which can only be achieved if the system used in 
the U.S. is consistently and uniformly applied throughout the nation 
and in conformance with the internationally harmonized system.
    Table SI-1, derived from material presented in Section VI of this 
preamble, provides a summary of the costs and benefits of the final 
rule. As shown, the final rule is estimated to prevent 43 fatalities 
and 521 injuries and illnesses annually. Also as shown, OSHA estimates 
that the monetized health and safety benefits of the final rule are 
$250 million annually and that the annualized cost reductions and 
productivity gains are $507 million annually. In addition, OSHA 
anticipates that the final rule will generate substantial (but 
unquantified) savings from simplified hazard communication training and 
from expanded opportunities for international trade due to a reduction 
in trade barriers.
    The estimated cost of the rule is $201 million annually. As shown 
in Table SI-1, the major cost elements associated with the final rule 
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 ($22.5 million); 
training for employees to become familiar with new warning symbols and 
the revised safety data sheet format ($95.4 million); management 
familiarization and other management-related costs as may be necessary 
($59.0 million); and costs to purchase upgraded label printing 
equipment and supplies or to purchase pre-printed color labels in order 
to include the hazard warning pictogram enclosed in a red-bordered 
diamond on the product label ($24.1 million).
    The final rule is estimated to generate net monetized benefits of 
$556 million annually, using a discount rate of 7 percent to annualize 
costs and benefits. Using a 3 percent discount rate instead would have 
the effect of lowering the costs to $161 million per year and 
increasing the gross benefits to $839 million per year. The result 
would be to increase net benefits from $556 million to $678 million per 
year.
    These estimates are for informational purposes only and have not 
been used by OSHA as the basis for its decision concerning the 
requirements for this final rule.

BILLING CODE 4510-26-P

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[GRAPHIC] [TIFF OMITTED] TR26MR12.000

BILLING CODE 4510-26-C

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I. Introduction

    In the preamble, OSHA refers to 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; however, some information (e.g., copyrighted 
material) is not publicly available to read or download through that 
Web site. All of the documents are available for inspection and, where 
permissible, copying at the OSHA Docket Office, U.S. Department of 
Labor, Room N-2625, 200 Constitution Avenue NW., Washington, DC 20210.

II. Events Leading to the Revised Hazard Communication Standard

    The HCS was first promulgated in 1983 and covered the manufacturing 
sector of industry (48 FR 53280, Nov. 25, 1983). (Please note: The 
Agency's HCS (29 CFR 1910.1200; 1915.1200; 1917.28; 1918.90; and 
1926.59) will be referred to as the ``current HCS'' throughout this 
rule.) In 1987, the Agency expanded the scope of coverage to all 
industries where employees are potentially exposed to hazardous 
chemicals (52 FR 31852, Aug. 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 regulated by OSHA since March 17, 1989 (54 FR 6886, Feb. 15, 
1989) (29 CFR 1910.1200; 1915.1200; 1917.28; 1918.90; and 1926.59). In 
1994, OSHA made minor changes and technical amendments to the HCS to 
help ensure full compliance and achieve better protection of employees 
(59 FR 6126, Feb. 9, 1994). The development of the HCS is discussed in 
detail in the preambles to the original and revised final rules (See 48 
FR at 53280-53281; 52 FR at 31852-31854; and 59 FR at 6127-6131). This 
discussion will focus on the sequence of events leading to the 
development of the GHS and the associated modifications to the HCS 
included in the final rule.
    The current HCS requires chemical manufacturers and importers to 
evaluate the chemicals they produce or import to determine if they are 
hazardous. The standard 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 through material safety data sheets, 
which are now called ``safety data sheets'' (SDS) under the final rule 
and in this preamble. 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. 
Generally, under the final rule, these obligations on manufacturers, 
importers, and employers remain, but how hazard communication is to be 
accomplished has been modified.
    To protect employees and members of the public who are potentially 
exposed to hazardous 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. The laws vary on 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 among the 
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, 
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 exercising other authority over the 
labeling of chemicals under the Toxic Substances Control Act. Each of 
these regulatory authorities operates under different statutory 
mandates, and all have adopted distinct hazard communication 
requirements.
    Tracking and complying with 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 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 promulgated in 1983. At 
that time, OSHA committed to periodically reviewing the standard 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 of the 1983 standard:

    * * * [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 at 53287)

    OSHA has actively participated in many 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 
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 
Labour Organization (ILO) to develop a convention and recommendations 
on safety in the use of chemicals at work (55 FR 2166, Jan. 22, 1990). 
On a closely related matter, OSHA published a second 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 safety data sheet 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 
labeling 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,

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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. 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 Sub-committee 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, other agencies were 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 email 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, Apr. 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. 
Countries were encouraged to implement the GHS as soon as possible, and 
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.
    OSHA published an Advance Notice of Proposed Rulemaking (ANPR) on 
the GHS in September of 2006 (71 FR 53617, Sept. 12, 2006). At the same 
time the ANPR was published, OSHA made available on its Web site a 
document summarizing the GHS (http://www.osha.gov). 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 the September 2009 Notice of 
Proposed Rulemaking (NPRM) (74 FR 50279-50549, Sept. 30, 2009). A 
notice of correction was published on November 5, 2009, in order to 
correct misprints in the proposal (74 FR 57278, Nov. 5, 2009). Over 100 
comments were received in response to the NPRM. Commenters represented 
the broad spectrum of affected parties and included government 
agencies, industries, professional and trade associations, academics, 
employee organizations and individuals. Public hearings were held in 
Washington, DC, from March 2 through March 5, 2010, and in Pittsburgh, 
PA, on March 31, 2010. Over 40 panels participated in the hearings. The 
comments, testimony, and other data received regarding this rulemaking 
were overwhelmingly favorable, and will be discussed in detail later in 
this preamble. The final post-hearing comment period for further 
submissions and briefs ended and the record was certified by 
Administrative Law Judge Stephen L. Purcell and closed on May 31, 2010. 
Executive Order 13563, emphasizing the importance of retrospective 
analysis of rules, was issued on January 18, 2011.
    This final rule is based on Revision 3 of the GHS. The adoption of 
the GHS will improve OSHA's current HCS standard by providing 
consistent, standardized hazard communication to downstream users. 
However, even after the U.S. and other countries implement the GHS, it 
will continue to be updated in the future. These updates to the GHS 
will be completed as necessary to reflect new technological and 
scientific developments as well as provide additional explanatory text. 
Any future changes to the HCS to adopt subsequent changes to the GHS 
would require OSHA's rulemaking procedures.
    OSHA will remain engaged in activities related to the GHS. The U.S. 
is a member of the United Nations Committee of Experts on the Transport 
of Dangerous Goods and the Globally Harmonized System of Classification 
and Labelling of Chemicals, as well as the Sub-committee of Experts on 
the Globally Harmonized System of Classification and Labelling of 
Chemicals, where OSHA is currently the Head of the U.S. Delegation. 
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 will also continue to 
participate in the GHS Programme Advisory Group under the United 
Nations Institute for Training and Research (UNITAR). UNITAR is

[[Page 17579]]

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 will also 
continue its involvement 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.

III. Overview of the Final Rule and Alternatives Considered

    Based on consideration of the record as a whole, OSHA has modified 
the HCS to make it consistent with the GHS. OSHA finds that harmonizing 
the HCS with the GHS will improve worker understanding of the hazardous 
chemicals they encounter every day. Such harmonization will also reduce 
costs for employers.
    OSHA believes that adopting the GHS will result in a clearer, more 
effective methodology for conveying information on hazardous chemicals 
to employers and employees. Commenters overwhelmingly supported the 
revision, and their submissions form a strong evidentiary basis for 
this final rule. The American Health Care Association stated that the 
GHS ``would enhance the effectiveness of the HCS in ensuring that 
employees are apprised of the chemical hazards to which they might be 
exposed'' (Document ID 0346). The National Institute of 
Environmental Health Sciences concurred, and added that adopting the 
GHS ``would provide better worker health and safety protections'' 
(Document ID 0347). (See also Document ID 0303, 0313, 
0322, 0324, 0327, 0328, 0329, 0330, 0331, 0334, 0335, 0336, 0339, 0340, 
0341, 0344, 0345, 0346, 0347, 0349, 0350, 0351, 0352, 0353, 0354, 0356, 
0357, 0359, 0363, 0365, 0367, 0369, 0370, 0371, 0372, 0374, 0375, 0376, 
0377, 0378, 0379, 0381, 0382, 0383, 0385, 0386, 0387, 0388, 0389, 0390, 
0392, 0393, 0396, 0397, 0399, 0400, 0402, 0403, 0404, 0405, 0407, 0408, 
0409, 0410, 0411, 0412, 0414, 0417, 0453, 0456, 0461, and 0463.)
    Consistent with Executive Order 13563, OSHA has concluded that the 
revision significantly improves the current HCS standard. Moreover, 
there is widespread agreement that aligning the HCS with the GHS would 
establish a valuable, systematic approach for employers to evaluate 
workplace hazards, and provide employees with consistent information 
regarding the hazards they encounter. A member of the United Steel 
Workers aptly summed up the revision by stating that ``the HCS in 1983 
gave the workers the `right to know' but the GHS will give the workers 
the `right to understand' '' (Document ID 0403). The American 
Society of Safety Engineers (ASSE) concurred, stating that adoption of 
the HCS was ``necessary to help this nation's workers deal with the 
increasingly difficult challenge of understanding the hazards and 
precautions needed to handle and use chemicals safely in an 
increasingly connected workplace'' (Document ID 0336). 
Phlymar, ORC, BCI, 3M, American Iron & Steel Institute, and the North 
American Metals Council (NAMC) all agreed that the adoption of the GHS 
would improve the quality and consistency of information and the 
effectiveness of hazard communication (Documents ID 0322, 
0336, 0339, 0370, 0377, 0390, 0405, and 0408). (See also Document ID 
0327, 0338, 0339, 0346, 0347, 0349, 0351, 0354, 0363, 0365, 
0370, 0372, 0374, 0379, 0389, 0390, 0397, 0405, 0408, and 0414.) The 
evidence supporting the Agency's conclusions is discussed more 
thoroughly below in Sections IV, V, and VI; the revisions to the HCS 
are discussed in detail in Section XIII.
    This section of the preamble provides an overview of the current 
HCS and how the adoption of the GHS will change this standard. 
Moreover, this section will also discuss the alternatives to mandatory 
implementation and the benefits of the final rule. The specific issues 
for which OSHA solicited comments in the NPRM will be discussed within 
their respective sections.

1. The Hazard Communication Standard

    The HCS requires a comprehensive hazard evaluation and 
communication process, aimed at ensuring that the hazards of all 
chemicals are evaluated, and also requires that the information 
concerning chemical hazards and necessary protective measures is 
properly transmitted to employees. The HCS 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.
    There are three information communication components in this 
system--labels, SDSs, and employee training, all of which are 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. 
The modifications that make up this final rule build on these core 
principles by establishing a more detailed and consistent 
classification system and requiring uniform labels and SDSs, which will 
better ensure that workers are informed and adequately protected from 
chemical exposures.

[[Page 17580]]

2. Current HCS Provisions for Classification, Labeling, and SDSs

    The current 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 current 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. Mandatory Appendix A of the current standard lists criteria 
for specific health effects; however, it also notes that these criteria 
are not intended to be an exclusive categorization scheme, but rather 
any available scientific data on the chemical must be evaluated to 
determine whether the chemical presents a health hazard. 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 ingredients in 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 current HCS also recognizes that 
risk may remain at concentrations below these cut-offs, and where there 
is evidence that that is the case, the mixtures are considered 
hazardous under the standard.
    The current 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 current HCS was issued in 1983, the public record strongly 
supported this performance-oriented approach (See 48 FR at 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.

3. 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 new systems.
    The GHS allows a regulatory authority to choose the provisions that 
are appropriate to its 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. This rule only adopts those sections 
of the GHS that are appropriate to OSHA's regulatory sector. For 
example, while the GHS includes criteria on classifying chemicals for 
aquatic toxicity, these provisions were not adopted because OSHA does 
not have the regulatory authority to address environmental concerns. 
The building block approach also gives regulatory agencies the 
authority to select which classification criteria and provisions to 
adopt. OSHA is adopting the classification criteria and provisions for 
labels and SDSs, because the current HCS covers these elements. Broad 
criteria were established for the GHS in order to allow regulatory 
bodies to apply the same standards to a wide array of hazards. The 
building block approach may also be applied to the criteria for 
defining hazard categories. As a result, the GHS criteria are more 
comprehensive than what was in the current HCS, and OSHA did not need 
to incorporate all of the GHS hazard categories into this final rule.
    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. For example, 
Carcinogenicity has two hazard categories. Category one is for known or 
presumed human carcinogens while category two encompasses suspected 
human carcinogens. The definitions of hazards are specific and 
detailed. For example, under the current HCS, a chemical is either an 
explosive or it is not. The GHS has seven categories of explosives, and 
assignment to these categories is based on the classification criteria 
provided. In order to determine which hazard class a mixture falls 
under, the GHS generally applies a tiered approach. When evaluating 
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 that is used for classification. The approach is 
generally consistent with the requirements of the pre-modified 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) must be 
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 or severity of the hazard.
    Precautionary statements are also required on GHS labels. The GHS 
provides precautionary statements; while they have been codified 
(numbered), they are not yet considered formally harmonized. In other 
words, regulatory authorities may choose to use different language for 
the precautionary statements and still be considered to be harmonized 
with the GHS. 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 the precautionary statements to be 
referenced 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 inclusion of 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

[[Page 17581]]

primary interest to exposed employees and emergency responders are 
presented at the beginning of the document, while more technical 
information is presented in later sections. 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).

4. Revisions to the Hazard Communication Standard

    The GHS uses an integrated, comprehensive process of identifying 
and communicating hazards, and the GHS modifications improve the HCS by 
providing more extensive criteria for defining the hazards in a 
consistent manner, as well as standardizing label elements and SDS 
formats to help to ensure that the information is conveyed 
consistently. The GHS does not include requirements for a written 
hazard communication program, and this final rule does not make 
substantive changes to the current HCS requirements for a written 
hazard communication program. Nor does the GHS impose employee training 
requirements; however, OSHA believes that additional training will be 
necessary to ensure that employees understand the new elements, 
particularly on the new pictograms. Therefore, modified training 
requirements have been included in the final rule in order to address 
the new label elements and SDS format required under this revised 
standard.
a. Modifications
    The revised HCS primarily affects manufacturers and importers of 
hazardous chemicals. Pursuant to the final rule, chemical manufacturers 
and importers are required to re-evaluate chemicals according to the 
new criteria in order to ensure the chemicals are classified 
appropriately. For health hazards, this will involve assigning the 
chemical both to the appropriate hazard category and subcategory 
(called hazard class). For physical hazards, these 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 to comply with DOT's transport requirements. This will 
minimize the work required for classifying physical hazards under the 
revised rule.
    Preparation and distribution of modified labels and safety data 
sheets by chemical manufacturers and importers will also be required. 
However, those chemical manufacturers and importers following the ANSI 
Z400.1 standard for safety data sheets should already have the 
appropriate format, and will only be required to make some small 
modifications to the content of the sheets to be in compliance with the 
final rule.
    Using the revised criteria, a chemical will be classified based on 
the type, the degree, and the severity of the hazard it poses. This 
information will help employers and employees understand chemical 
hazards and identify and implement protective measures. The detailed 
criteria for classification will result in greater accuracy in hazard 
classification and more consistency among classifiers. Uniformity will 
be a key benefit; by following the detailed criteria, classifiers are 
less likely to reach different interpretations of the same data.
b. Specific Changes From the Proposal
    Based on comments from the rulemaking effort, OSHA has made some 
modifications from the proposal to the final rule. These changes were 
the result of OSHA's analysis of the comments and data received from 
interested parties who submitted comments or participated in the public 
hearings. The major changes are summarized below and are discussed in 
the Summary and Explanation Section of this Preamble (Section XIII).

Safety Data Sheet

    In the proposal, OSHA asked interested parties to comment on 
whether OSHA's permissible exposure limits (PELs) should be included on 
SDSs, as well as any other exposure limit used or recommended by the 
chemical manufacturer, importer, or employer who prepares SDSs. After 
reviewing and analyzing the comments and testimony, OSHA has decided 
not to modify the HCS with regard to the American Conference of 
Government Industrial Hygienists (ACGIH) Threshold Limit Values (TLVs) 
and so will continue to require ACGIH TLVs on SDSs. We have also 
retained the classification listings of the International Agency for 
Research on Cancer (IARC) and the National Toxicology Program (NTP) on 
SDSs. As explained more fully in the Summary and Explanation, OSHA 
finds that requiring ACGIH TLVs as well as the IARC and NTP 
classification listings on the SDS will provide employers and employees 
with useful information to help them assess the hazards presented by 
their workplaces.

Labels

    As discussed in the NPRM, the GHS gives individual countries the 
option of using black, rather than red, borders around pictograms for 
labels used in domestic commerce. OSHA proposed requiring red frames 
for all labels, domestic and international. The final rule carries 
forward this requirement. As discussed in Sections IV and XIII, studies 
showed that there is substantial benefit to the use of color on the 
label. The color red in particular will make the warnings on labels 
more noticeable, because red borders are generally perceived to reflect 
the greatest degree of hazard. Further, while commenters who objected 
to this requirement cited the cost of printing in red ink as a reason 
to allow domestic use of black borders, OSHA was unconvinced that the 
costs involved made the provision infeasible, excessively burdensome, 
or warranted the diminished protection provided by black borders. (See 
Sections VI and XIII below.)
    One option suggested by commenters was requiring a red label but 
allowing manufacturers and importers to use preprinted labels with 
multiple red frames. This would save costs because the preprinted label 
stock could be used for different products requiring different 
pictograms. Use of this option, however, would mean that the label for 
a particular chemical might have empty red frames if the chemical did 
not require as many pictograms as there were red frames on the label 
stock.
    As explained in Sections IV and XIII, OSHA has concluded that a red 
border without a pictogram can create confusion and draw worker 
attention away from the appropriate hazard warnings (See Section IV for 
more detail). Additionally, OSHA is concerned that empty red borders 
might be inconsistent with DOT regulations (See 49 CFR 172.401). 
Therefore, while OSHA is not opposed to the use of preprinted stock, 
OSHA has decided not to allow the use of blank red frames on finished 
labels.

Hazard Classification

    Another change to the final rule is the inclusion of the IARC and 
NTP as resources for determining carcinogenicity. Commenters generally 
supported this modification, and OSHA believes the inclusion of this 
information will assist evaluators with the classification process. 
Therefore, descriptions of both the IARC and NTP classification 
criteria have been added to Appendix F, and IARC and NTP 
classifications may be used to determine

[[Page 17582]]

whether a chemical should be classified as a carcinogen.

Unclassified Hazards

    OSHA has made several modifications to clarify and specify the 
definition for unclassified hazards, based on the comments provided. 
Executive Order 13563 states that our regulatory system ``must promote 
predictability and reduce uncertainty,'' and these efforts at 
clarification are designed to achieve that goal. OSHA included this 
definition to preserve existing safeguards under requirements of the 
HCS for chemical manufacturers and importers to disseminate information 
on hazardous chemicals to downstream employers, and for all employers 
to provide such information to potentially exposed employees. Inclusion 
of the definition does not create new requirements. OSHA has made 
certain changes to clarify application of the definition, and to ensure 
that the relevant provisions do not create confusion or impose new 
burdens.
    In order to minimize confusion, OSHA has renamed unclassified 
hazards, ``hazards not otherwise classified.'' More fundamentally, and 
in response to the majority of the comments on this issue, OSHA has 
removed from the coverage of the general definition the hazards 
identified in the NPRM as not currently classified under the GHS 
criteria. These hazards are: pyrophoric gases, simple asphyxiants, and 
combustible dust. As described below, OSHA has added definitions to the 
final rule for pyrophoric gases and simple asphyxiants, and provided 
guidance on defining combustible dust for purposes of complying with 
the HCS. In addition, the Agency has also provided standardized label 
elements for these hazardous effects.

Precautionary/Hazard Statements

    In response to concerns by commenters that, on occasion, a 
specified precautionary statement might not be appropriate, OSHA 
modified mandatory Appendix C to provide some added flexibility. Where 
manufacturers, importers, or responsible parties can show that a 
particular statement is inappropriate for the product, that 
precautionary statement may be omitted from the label. This is 
discussed in more detail in section XIII below.

Other Standards Affected

    Changing the HCS to conform to the GHS requires modification of 
other OSHA standards. For example, modifications have been made 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. Modifications to the Process Safety Management of 
Highly Hazardous Chemicals standard (29 CFR 1910.119) will ensure that 
the scope of the standard is not changed by the revisions to the HCS. 
In addition, modifications have been made to most of OSHA's substance-
specific health standards, ensuring that requirements for signs and 
labels and SDSs are consistent with the modified HCS.

Effective Dates

    In the proposal, OSHA solicited comments regarding whether it would 
be feasible for employers to train employees regarding the new labels 
and SDSs within two years after publication of the final rule. 
Additionally, OSHA inquired as to whether chemical manufacturers, 
importers, distributors, and employers would be able to comply with all 
the provisions of the final rule within three years, and whether a 
phase-in period was necessary.
    OSHA received many comments and heard testimony regarding the 
effective dates which are discussed in detail in Section XIII below. 
First, after analysis of the record, the Agency has determined that 
covered employers must complete all training regarding the new label 
elements and SDS format by December 1, 2013 since, as supported by 
record, employees will begin seeing the new style labels considerably 
earlier than the compliance date for labeling. Second, OSHA is 
requiring compliance with all of the provisions for preparation of new 
labels and safety data sheets by June 1, 2015. However, distributors 
will have an additional six months (by December 1, 2015) to distribute 
containers with manufacturers' labels in order to accommodate those 
they receive very close to the compliance date. Employers will also be 
given an additional year (by June 1, 2016) to update their hazard 
communication programs or any other workplace signs, if applicable.
    Additionally, OSHA has decided not to phase in compliance based on 
whether a product is a substance or a mixture. OSHA has concluded that 
adequate information is available for classifiers to use to classify 
substances and mixtures. Finally, as discussed in the NPRM, employers 
will be considered to be in compliance with the HCS during the 
transition period as long as they are complying with either the 
existing HCS (as it appears in the CFR as of October 1, 2011) or this 
revised HCS. A detailed discussion regarding the effective dates is in 
Section XIII.

5. Alternatives of Mandatory Implementation

    In the NPRM, OSHA proposed several alternatives to mandatory 
implementation of the GHS in response to concerns raised by commenters 
through the ANPR (74 FR at 50289). Commenters generally supported the 
concept of adopting the GHS as it was proposed. However, a few 
commenters indicated that they were concerned with what they saw as the 
cost burden on small businesses that are not involved in international 
trade. To address these concerns, OSHA solicited comments in the NPRM 
on several options proposed by the Agency regarding alternatives to 
mandatory harmonization. The following is a discussion of these 
alternatives; the potential impact and the response from participants 
in the rulemaking regarding the relative benefit, feasibility, impact 
on small business; and the impact on worker safety and health.
    The first alternative OSHA proposed was to facilitate voluntary 
adoption of GHS within the existing HCS framework, and give 
manufacturers and importers the option to use the current HCS or the 
GHS system. This option would have permitted companies to decide 
whether they wanted to comply with the existing standard or with the 
GHS. A variation of this alternative was also proposed that would have 
adopted the GHS with an exemption allowing small chemical producers to 
continue to use the HCS, even after this GHS-modified HCS is 
promulgated.
    The second alternative was a limited adoption of specific GHS 
components. Under this approach, producers could either comply with the 
GHS or a modified HCS that would retain the current HCS hazard 
categories, but require standardized hazard statements, signal words, 
and precautionary statements. A variation of this alternative would 
have omitted mandatory precautionary statements.
    Commenters almost universally objected to both of the alternatives 
listed above (Document ID 0324, 0328, 0329, 0330, 0335, 0338, 
0339, 0341, 0344, 0351, 0352, 0355, 0365, 0370, 0377, 0381, 0382, 0385, 
0387, 0389, 0393, 0495, 0403, 0404, and 0412). American Industrial 
Hygiene Association (AIHA), in a representative comment, stated that 
``permitting voluntary use of some of the system * * * or exempting 
certain sectors based on business size or other criteria [would] defeat 
the purpose of revising this standard and of the GHS'' (Document ID 
0365). Additionally, the

[[Page 17583]]

Compressed Gas Association stated they ``would not support any 
alternative approach as it would defeat the goal of global hazard 
communication coordination'' (Document ID 0324).
    Many commenters argued that a dual system that permitted businesses 
to opt out of complying with the GHS would undermine the key benefits 
of implementation. For example, Ferro Corporation stated that ``for GHS 
to be effective and efficient in the U.S., implementation should be 
consistent and congruent'' (Document ID 0363). DuPont Company 
argued ``dual systems would be confusing for employers'' (Document ID 
0329). ORC also rejected voluntary implementation, reasoning 
that ``consistent requirements for all manufacturers and importers of 
chemicals [are] needed to maximized efficiency in the chemical supply 
chain'' (Document ID 0370). Additionally, the AFL-CIO cited 
consistent hazard information for workers and employers as the core 
objective of this rulemaking (Document ID 0340).
    The commenters who supported GHS as proposed indicated that 
consistency was an essential aspect of this rule. Stericycle, Inc., 
stated that SDSs which ``do not follow a consistent format would cause 
issues in understanding and implementing the controls to limit exposure 
and protect employee safety and health,'' and argued that exemptions 
from GHS requirements would ``shift the burden from the chemical 
industry to all employers'' (Document ID 0338). Additionally, 
commenters did not support exempting small businesses from adopting the 
GHS. Ecolab argued that ``large and small businesses use each others' 
products'' and are inextricably linked, and they indicated that 
voluntary adoption ``could cause confusion about product hazards if two 
identical products are labeled differently due solely to the size of 
the business from which [they are] obtained'' (Document ID 
0351).
    OSHA agrees that the first alternative is unworkable as even one 
business's adoption of one of the alternatives would affect other 
companies. As stated in the comments above, if small businesses do not 
adopt the GHS, then large businesses or distributors will either have 
to generate GHS classifications for chemicals purchased, 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 who are unknown to the 
original producer. This would lead to a plethora of product labels, a 
situation that is bound to make hazard communication far more 
difficult.
    Commenters specifically cited issues with safety as their basis for 
rejecting the first proposed alternative. The AIHA (Document ID 
0365) stated:


    If employers and employees cannot have confidence that labels 
and MSDSs provide a consistent safety message superficial 
standardization will not improve safety. Safety is also seriously 
compromised if different hazard communication systems are present in 
the work area. Effective training is not possible if pictograms and 
hazard statements are not used in a consistent manner * * *. All of 
the approaches discussed will create competitive pressures that can 
affect classification decisions and make good and consistent hazard 
communication more difficult.

North American Metal Council argued that the alternative would penalize 
workers of small business, and asserted that a ``worker's right to know 
about chemical hazards, should not depend on the source of a chemical 
or the size of the worker's employer'' (Document ID 0337).
    Moreover, commenters asserted that the benefits derived from the 
harmonized labeling of chemicals would be significantly diluted if 
employers were not uniformly required to adopt the GHS. United Steel 
Workers Union aptly reiterated that the primary benefit of adopting the 
GHS is not the facilitation of international trade, but rather is the 
protection of workers, which is ``best accomplished through a uniform 
system of classification leading to comprehensible hazard information'' 
(Document ID 0403). (See also Document ID 0339, 0351, 
0376, 0377, 0382, and 0412.)
    Several commenters supported the voluntary adoption of the GHS 
(Document ID 0355, 0389, and 0502). For example, 
Intercontinental Chemical Corporation supported voluntary adoption for 
companies not involved in international trade (Document ID 
0502). Additionally, Betco supported allowing ``small 
businesses that market domestically'' to retain the current HCS and 
suggested that ``voluntary adoption would not be any less protective 
for employees or create confusion'' (Document ID 0389).
    OSHA acknowledges that small chemical manufacturers will have some 
burdens associated with the adoption of GHS. However, employees who use 
products produced by small employers are entitled to the same 
protections as those who use products produced by companies engaged in 
international trade. The confusion created by two or more competing 
systems would undermine the consistency of hazard communication 
achievable by a GHS-modified HCS. Moreover, whether or not a product 
will wind up in international trade may not be known to the 
manufacturer or even the first distributer. A producer may provide a 
chemical to another company, which then formulates it into a product 
that is sold internationally. Thus, the original producer is involved 
in international trade without necessarily realizing it. For these 
reasons, OSHA has determined that, in order to achieve a national, 
consistent standard, all businesses must be required to adhere to the 
revised HCS.
    OSHA concludes that the rulemaking record does not support adoption 
of the first alternative. The majority of private industry, unions, and 
professional organizations did not support this approach, arguing 
persuasively that piecemeal adoption would undermine the benefits of 
harmonization. As discussed above, while improvements to international 
trade are a benefit of this rulemaking; they are not the primarily 
intended benefit. OSHA believes that implementation of the GHS, without 
exceptions based on industry or business size, will enhance worker 
safety through providing consistent hazard communication and, 
consequently, safe practices in the workplace. However, as indicated 
above, OSHA does recognize that there are burdens with any change and 
as discussed in Section XIII, OSHA will use the input OSHA has received 
to the record to develop an outreach plan for additional guidance.
    The second alternative, a halfway measure allowing businesses to 
adopt some of the features of a GHS-modified HCS but not requiring 
adoption of others, drew little interest or comment from the 
participants. OSHA has concluded that this alternative, which would 
have led to even more inconsistencies in hazard communication, is not a 
viable alternative. OSHA's conclusion is supported by the overwhelming 
number of commenters who spoke out against the first option and 
strongly supported the proposed standard. Allowing employers to adopt, 
say, only the provisions for the labels or safety data sheets will 
result in inconsistent use of the standardized hazard statement, signal 
word, and precautionary statement without clear direction on when they 
would be required, a situation that is sure to compromise safety in the 
workplace. Therefore, OSHA has concluded that implementation of the GHS 
is also preferable to the second alternative.

[[Page 17584]]

    Pursuant to its analysis of the entire rulemaking record, OSHA has 
decided to adopt the GHS as proposed and is not incorporating any of 
the alternatives into this final rule. The adoption of any of the 
alternatives would undermine the key benefits associated with the GHS. 
OSHA has concluded, as discussed in Section V, that the adoption of GHS 
as proposed will strengthen and refine OSHA's hazard communication 
system, leading to safer workplaces.

IV. Need and Support for the 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 the 
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 Hazard Communication Standard (HCS) was issued in 
1983 (48 FR 53282-53284, Nov. 25, 1983). As noted in the NPRM (74 FR 
50291, Sept. 30, 2009), 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. During the September 
29, 2009, press conference announcing the publication of the HCS NPRM, 
Deputy Assistant Secretary of Labor for Occupational Safety and Health, 
Jordan Barab, discussed the impact that the HCS has had on reducing 
injury and illness rates. Mr. Barab stated that, since the HCS's 
original promulgation in 1983, ``OSHA estimates that chemically-related 
acute injuries and illness [have] dropped at least 42%.'' Reiterating 
information from OSHA's preliminary economic analysis in the NPRM, Mr. 
Barab also stated:

    [T]here are still workers falling ill or dying from exposure to 
hazardous chemicals. OSHA estimates, based on BLS data, that more 
than 50,000 workers became ill and 125 workers died due to acute 
chemical exposure in 2007. These numbers are dwarfed by chronic 
illnesses and fatalities that are estimated in the tens of 
thousands.
    OSHA believes that aligning the Hazard Communication Standard 
with the provisions of the GHS will improve the effectiveness of the 
standard and help to substantially improve worker safety and health. 
The GHS will provide a common system for classifying chemicals 
according to their health and physical hazards and it will specify 
hazard communication elements for labeling and safety data sheets.

    Data collected and analyzed by the Agency also reflect this 
critical need to improve hazard communication. 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, Nov. 25, 1983). 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, Document ID 0299; Leigh et al., 1997, 
Document ID 0274; Landrigan and Markowitz, 1989, Document ID 
0299).
    While the current HCS serves to ensure that information concerning 
chemical hazards and associated protective measures is provided to 
employers and employees, the Agency has determined that the revisions 
adopted in this final rule will substantially improve the quality and 
consistency of the required information. OSHA believes these revisions 
to the HCS, which align it with the GHS, will enhance workplace 
protections significantly. Better information will enable employers and 
employees to increase their recognition and knowledge of chemical 
hazards and take measures that will reduce 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 principle 
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.''
    As was discussed in the proposal (74 FR 50291), 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. One such study, prepared by researchers at the 
University of Maryland, entitled ``Hazard Communication: A Review of 
the Science Underpinning the Art of Communication for Health and 
Safety'' (Sattler et al., 1997, Document ID 0191) has also 
long been available to the public on OSHA's Hazard Communication web 
page. Additionally, 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, Document ID 0246).
    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 on comprehensibility 
testing (See GHS Annex 6, Comprehensibility Testing Methodology) 
(United Nations, 2007, Document ID 0194). 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

[[Page 17585]]

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.
    Another principle that was established to guide development of the 
GHS was the agreement that levels of protection offered by an existing 
hazard communication system should not be reduced as a result of 
harmonization. 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 35 member nations as well as 14 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.
    United States-based scientific and professional associations have 
endorsed adoption of the GHS since publication of the Advance Notice of 
Proposed Rulemaking (ANPR) in 2006 (71 FR 53617, Sept. 12, 2006). For 
example, the American Chemical Society (ACS) indicated its support for 
the GHS, stating: ``The American Chemical Society 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). 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). 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'' (Document ID 0304). 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). Responders to the 2009 NPRM reiterated their support or, in the 
case of new commenters, echoed the comments from other scientific and 
professional associations to the ANPR (See, e.g., Document ID 
0338, 0357, 0365, 0393, and 0410). The positions taken by 
these organizations point to wide support for the GHS among the 
scientific and professional communities.
    Stakeholders representing a wide range of sectors and interests 
agreed with OSHA that aligning the HCS with the GHS will improve 
comprehensibility, and thus lead to reductions in chemical source 
illnesses and injuries. American Society of Safety Engineers, Dow 
Chemical, and ORC all voiced their support for the proposed rule, 
citing improved comprehensibility and quality of transmitted 
information as key benefits (Document ID 0336, 0353, and 
0370). Representing union labor, the American Federation of State, 
County and Municipal Employees (AFSCME) stated that this rulemaking 
would ``allow critical communication about the hazards of chemicals to 
be understood by all workers, regardless of their literacy level or 
primary language * * * [and] will in turn lead to safer, more 
productive workplaces'' (Document ID 0414). Many stakeholders 
asserted that adopting the GHS would lead to safer workplaces. The 
Chamber of Commerce provided its support for the rulemaking, stating 
that the GHS could ``improve worker safety, and facilitate business 
growth and international trade'' (Document ID 0397). The 
American Subcontractors Association, Inc. added that consistent hazard 
communication is critical to having a safe work program (Document ID 
0322). Additionally, North American Metals Council (NAMC), 
which represents the interests of the metals and mining industry, 
stated that a single, globally harmonized classification and labeling 
system is of vital interest to its members (Document ID 0233). 
The position that GHS would increase worker protection was also raised 
in testimony during the hearings. Elizabeth Treanor of Phylmar 
Regulatory Roundtable testified that adopting the GHS would ``enhance 
the effectiveness of the hazard communication standard by improving the 
quality and consistency of chemical hazard information that is provided 
to employees and employers'' (Document ID 0497 Tr. 92).
    In addition to the endorsement of the GHS by a group of experts 
with extensive knowledge and experience in chemical hazard 
communication, support from scientific and professional associations 
with expertise in this area, and support from industry and labor 
stakeholders, a substantial body of evidence indicates that the 
modifications to the HCS will better protect employees. Specifically, 
this evidence supports OSHA's findings that: (1) Standardized label 
elements--signal words, pictograms, hazard statements and precautionary 
statements--will be more effective in communicating hazard information; 
(2) standardized headings and a consistent order of information will 
improve the utility of SDSs; and (3) training will support and enhance 
the effectiveness of the new label and SDS requirements.
    This evidence was obtained from sources predating the ANPR and from 
more recent data. OSHA commissioned several studies to examine the 
quality of information on SDSs (Karstadt, 1988, Document ID 
0296; Kearney/Centaur 1991a, 1991b, Document ID 0309 
and 0310; Lexington Group, 1999, Document ID 0257); the 
General Accounting Office (GAO) has issued two reports based on its 
evaluation of certain aspects of the HCS (GAO 1991 and 1992, Document 
ID 0271 and 0272); 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, Document ID 0260); and a substantial amount of 
scientific literature relating to hazard communication has been 
published. As mentioned previously, OSHA

[[Page 17586]]

commissioned a review of the literature, and a report based on that 
review was published in 1997 (Sattler et al., 1997, Document ID 
0191). An updated review was conducted in 2007 (ERG, 2007, 
Document ID 0246). In addition, OSHA conducted a review of the 
requirements of the HCS and published its findings in March of 2004 
(OSHA, 2004, Document ID 0224). Key findings derived from 
these sources are discussed below.
    No commenters questioned the validity of studies presented in the 
NPRM. Similarly, commenters did not question OSHA's analysis or 
interpretation of the study findings. Only one commenter suggested that 
OSHA should adopt more ``conservative expectations for the effects that 
warning format changes can have on the behavior of end users,'' adding 
that ``real-world conditions'' must be accounted for when determining 
the actual responses of users (Document ID 0396). However, the 
commenter did not disagree with OSHA's overall conclusion that this 
final rule would improve safety. OSHA agrees that external factors may 
influence the overall benefits of label elements (this will be 
addressed in Section VI).
    The studies discussed in the NPRM formed the evidentiary basis for 
the revised HCS. As such, OSHA infers that commenters generally found 
the studies, as well as OSHA's analysis, to be sound. 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 the 
classification process by establishing categories of hazard within most 
hazard classes. These categories indicate the relative degree of 
hazard, and thereby provide a basis for determining precise hazard 
information that is tailored to the level of hazard posed by the 
chemical. The classification criteria established in the GHS thus 
provide the necessary basis for development of the specific, detailed 
hazard information that would enhance the protection of employees.

Labels

    Labels serve as immediate visual reminders of chemical hazards, and 
complement the information presented in training and on SDSs. The 
current HCS 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.
    In the NPRM, OSHA proposed to improve the HCS by changing the 
performance requirements for labels to the GHS-specific requirements 
that labels include four standardized elements: a signal word; hazard 
statement(s); pictogram(s); and precautionary statement(s) (See Section 
XV for a detailed discussion of the requirements). The appropriate 
label elements for a chemical are to be determined by the hazard 
classification. OSHA has concluded that these standardized label 
elements better convey critically important hazard warnings, and 
provide useful information regarding precautionary measures that will 
serve to better protect employees than the performance-oriented 
approach of the current rule.
    This requirement is different from the current HCS in that it will 
require consistent and detailed information regarding a chemical based 
on the hazard classification. The current rule does not specify a 
standard format or design elements for labels. Rather, all that is 
required in the current HCS is that the label of the 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.
    Additionally, as discussed in the proposal (74 FR 50291, Sept. 30, 
2009), a great deal of literature has been developed that examines the 
effectiveness of warnings on labels. These studies support OSHA's 
adoption of standardized warnings on the labels of hazardous chemicals. 
Although the studies discussed below pertain to prescription and non-
prescription medications, alcoholic beverages, or consumer products 
rather than hazardous chemicals, it does not diminish the importance or 
relevance of the data. This literature provides a substantial body of 
information directly applicable and analogous 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. The studies are 
discussed below in the specific labeling sections.

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.
    This final rule requires the use of 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 
descending order of severity (ANSI, 2006, Document ID 0280).
    A number of studies have examined how people perceive signal words 
and,

[[Page 17587]]

in particular, how they perceive signal words to be different from one 
another. Overall, this research supports the use of signal words on 
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, 
Document ID 0300). 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, Document ID 0235). 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, Document ID 0281).
    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, Document ID 0308). The 
results failed to show a difference between WARNING and CAUTION. Among 
other words tested, DEADLY was seen as having the strongest arousal 
connotation, and NOTE the least.
    Griffith and Leonard asked 80 female undergraduates (who were 
unlikely to have already received industrial safety training) to rate 
signal words. Results included a list of terms in order of 
``meaningfulness,'' representing conceptual ``distance'' from the 
neutral term NOTICE (Griffith and Leonard, 1997, Document ID 
0250). 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, Document ID 
0286). 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, Document ID 
0289). 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, Document ID 0244). 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, Document ID 0252). 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, Document ID 0253). 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, Document ID 
0237). 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, Document ID 0311). In a large study on SDS and label 
comprehensibility conducted for South Africa's National Economic 
Development and Labour

[[Page 17588]]

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 
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.
    In response to the NPRM, OSHA received a comment from Croplife 
America about the impact of using a two-tiered signal word system on 
pesticide labels (Document ID 0387). Croplife America 
explained that they believe a three-tiered system (DANGER, WARNING and 
CAUTION) provides ``a little more distinction in the relative toxicity 
of a compound'' and ``if everything says `warning,' we run the risk of 
diluting the effectiveness of the signal word'' (Document ID 
0495 Tr. 251). During the informal public hearings, OSHA 
requested that Croplife America support their position on why a three-
tiered warning system is better than a two-tiered system. To support 
this assertion, Croplife America submitted a late comment containing an 
additional paper by Hellier et al. which analyzed how signal words are 
interpreted (Hellier et al., 2007, Document ID 0646).
    This paper discusses two studies performed in 2007 to analyze if 
alternative information is communicated with signal words (Hellier et 
al., 2007, Document ID 0646). Using 17 signal words, 30 
undergraduate students were asked to rate the similarities of paired 
signal words. In the first study, the result ratings revealed that 
signal words were interpreted by the participants along three 
dimensions; dimension one: the level of hazard implied by the signal 
words, dimension two: the extent to which they explicitly implied a 
risk, and dimension three`: the clarity of the instruction given by the 
signal word. Using the same signal words as in the first study, the 
second study explored how these signal words were interpreted by the 
study participants. Using statistical analysis, the analysis confirmed 
that the participants were able to discern the levels of hazard implied 
by the signal words and how it to relates to the explicitness of the 
implied risk (dimensions one and two). The results of the third 
dimension were unclear. The studies indicate that the extent to which 
signal words imply risk is important--people may not respond when 
repeatedly exposed to warnings that do not explicitly imply a risk. The 
results support using signal words to denote the level of hazard 
implied by the situation, and that there might be utility in using 
signal words to convey both information about a potential risk and the 
level of hazard.
    Even if it had been timely submitted, OSHA is not convinced that 
this study supplies sufficient evidence that using a two-tiered signal 
word approach will diminish the chemical user's ability to distinguish 
hazard severity. In OSHA's opinion, if anything, the Hellier study 
provides additional support for the use of signal words on labels to 
attract attention and to identify levels of hazard. Indeed, its results 
show that the signal word ``caution'' was substantially less connected 
by participants with communicating hazards than ``warning'' and 
``danger,'' which supports OSHA's decision not to use ``caution'' as a 
signal word. The record supports OSHA's determination that using the 
signal word in combination with the hazard statement alerts the 
chemical user to the hazard and allows him or her to distinguish the 
level of hazard severity posed by hazardous chemicals in the workplace.
    Commenting on the studies presented in the proposal, Applied Safety 
and Ergonomics (ASE) agreed that there are benefits associated with the 
standardization of warning elements. However, they also urged ``OSHA to 
adopt more conservative expectations for the effect that warning format 
changes can have on the behavior of end users'' (Document ID 
0396). See Section VI of this final rule for a detailed 
discussion of the benefits of standardized warning elements. OSHA does 
not disagree with these comments and has determined that requiring the 
use of the combined labeling elements (pictograms, signal words, hazard 
statements, and precautionary statements) will result in a uniform and 
consistent system of identifying and communicating chemical hazards in 
the workplace. No other comments were received on the studies OSHA used 
in its discussion of the need for signal words in this revised HCS.
    Comments received from stakeholders support the revision of the HCS 
to include the use of standardized signal words (Document ID 
0321, 0338, 0339, and 0349). For example, the Communications 
Workers of America (CWA) stated: ``Clearly, the Rule's requirements 
regarding revised SDSs and labeling provisions requiring the use of 
standardized signal words, pictograms, and hazard and precautionary 
statements would prove invaluable to affected CWA members whom have 
been exposed to hazardous chemicals and chemical products that have 
produced negative health effects and medical problems'' (Document ID 
0349). These comments support OSHA's conclusion that signal 
words alert chemical users to a hazard and indicate a particular level 
of hazard.
    After reviewing the comments received and the evidence presented in 
the record, OSHA has determined that, in this revised rule, use of the 
signal words ``DANGER'' and ``WARNING'' is appropriate.

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 included 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 on 
a label were to be determined based on the hazard classification of the 
substance in question. OSHA has found ample evidence to support the 
requirement for pictograms.
    A study by Kalsher et al. reported that users preferred labels with 
pictorials. The authors concluded that pictorials focused the attention 
of the user, helped users who were unable to read the small font size 
or print on the labels, and were useful for individuals who did not 
understand English (Kalsher et al., 1996, Document ID 0256). 
The presence of the symbol can attract attention to the warnings and 
are more memorable than written warnings (Parsons et al., 1999, 
Document ID 0262). Symbols serve several important functions 
in warning labels. As Wogalter et al. explained (Wogalter et al., 2006, 
Document ID 0275), symbols may alert the user to a hazard more 
effectively than text alone:

    Symbols may be more salient than text because of visual 
differentiations of shape, size, and color. Usually symbols have 
unique details and possess more differences in appearance than do 
the letters of the alphabet. Letters are highly familiar and are 
more similar to one another than most graphical symbols.

    Other investigators have examined the benefits of pictograms for 
those with low literacy levels and those who do not understand the 
language in which the

[[Page 17589]]

label text is written. A study by Parsons et al. concluded that 
nonverbal graphics are especially helpful for ensuring that 
individuals, who do not speak English or who have limited understanding 
of English, understand the meaning of the intended warning (Parsons et 
al., 1999, Document ID 0262). Another study has shown that 
people with low literacy skills can, with the help of pictographs, 
recall large amounts of medical information over significant periods of 
time (Houts et al., 2001, Documents ID 0254).
    Several researchers have sought to evaluate how people comprehend 
symbols, including the symbols that were proposed to be required. 
Several studies have found that the skull and crossbones icon--one of 
the symbols proposed and included in the final rule--is among the most 
recognizable of safety symbols. For example, Wogalter et al. asked 112 
undergraduates and community volunteers to rank various label elements 
(Wogalter et al., 1998, Document ID 0244). 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, 
Document ID 0196). The skull was rated significantly higher 
than all other symbols.
    Several studies have examined other pictograms included in the 
final 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 final rule 
(Akerboom and Trommelen, 1998, Document ID 0236). The authors 
reported the following levels of comprehension for these pictograms:
    [ssquf] Flame: 93 percent comprehension;
    [ssquf] Skull and crossbones: 85 percent comprehension;
    [ssquf] Corrosion: 20 percent comprehension; and
    [ssquf] 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, Document 
ID 0276). The authors recommend that labels present the hazard 
phrase [statement] and symbol together, along with corresponding 
precautions, as has been included as a requirement in the final rule.
    Banda and Sichilongo tested comprehension of labels among 364 
workers in four sectors in Zambia (transport, agriculture, industrial, 
and household consumers) (Banda and Sichilongo, 2006, Document ID 
0237). 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, Document ID 0311). ``Exploding bomb'' was 
correctly comprehended by 44 to 71 percent of each sector. On the other 
hand, 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 comprehended 
symbol.
    These findings indicate that some of the pictograms included in the 
final rule are already widely recognized by a general audience. Others, 
however, are not commonly understood. Therefore, simply adding some of 
the 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, Document ID 
0275). These results emphasize the need to train employees on 
the meaning of the pictograms that will 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, Document ID 0254). 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, Document 
ID 0275). 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; Document ID 0192). 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, Document ID 
0243).
    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, Document ID 0256). 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, Document ID 
0281). 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.
    Where chemical labels are concerned, London found that symbols tend 
to be the most easily recalled label elements (London, 2003, Document 
ID 0311). In the comprehensibility test of labels

[[Page 17590]]

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. The 
author concludes that ``Symbols are therefore key to attracting 
attention and informing risk perception regarding a chemical'' (London, 
2003, Document ID 0311).
    Wogalter et al. found factors other than pictorials influenced 
workers (Wogalter et al., 1993, Document ID 0285). 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, Document ID 0210). 
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 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, Document ID 0288). 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, Document ID 
0288). 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, Document 
ID 0264). The 96 adults who were tested were less confused, 
were more satisfied, were 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, 1990, Document ID 0290). 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.
    NIOSH submitted an additional study at the informal public hearings 
that analyzed the use of pictograms on labels. In 1997, Wilkinson et 
al. (Document ID 0480.6), interviewed 206 farmers in Victoria 
Australia. Two widely used agricultural herbicides were used for the 
basis of the research. The researchers developed three ``mocked-up'' 
labels for each herbicide--one containing existing warning text, one 
containing existing text with pictograms of appropriate safety 
precautions, and one containing text with pictograms that had been 
tested for recognition and comprehension across a variety of cultures 
and literacy levels. The interviewees answered questions using a rating 
scale, which was subjected to a statistical analysis to determine the 
significance of the responses. The authors concluded that ``the labels 
with added pictograms were perceived by pesticide users as 
significantly easier to obtain information from than labels containing 
text only'' (Document ID 0480.6).
    Stakeholders on the whole supported the inclusion of pictograms on 
the labels of hazardous substances. During the hearings, Chris Trahan 
of the AFL-CIO voiced support for including pictograms on the labels of 
hazardous chemicals, and cited construction workers as a group whose 
safety and health conditions would be greatly improved by OSHA's 
adoption of ``a system of symbols [workers] can then readily use to 
make decisions on a daily basis'' (Document ID 0494 Tr. 8).
    As discussed in the proposal, a considerable amount of evidence 
shows that pictograms can serve as useful and effective communication 
tools. In the final rule, OSHA has decided to adopt the eight GHS 
pictograms initially proposed in the NPRM. 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 particular label are to be determined 
based on the hazard classification of the substance in question.
    OSHA finds, based on scores of supporting studies and persuasive 
testimony that the pictograms will make warnings on labels more 
noticeable and easier for employees to understand. In particular, 
symbols will improve comprehension among people with low literacy 
levels and those who are not literate in the English language. 
Moreover, pictograms will be used not only in conjunction with other 
label elements, but also in the context of the hazard communication 
program as a whole. Training that includes an explanation of labels 
(included in the final rule) will ensure that the pictograms are 
understood by employees.

Red Borders

    GHS allows regulatory authorities the option of permitting black 
pictogram borders for labels on domestic products, and in the proposal 
OSHA requested comment on this issue. Mandating the use of red borders 
was supported by stakeholders, who argued persuasively that red borders 
would make labels more noticeable and would make the warnings appear to 
be more important (Document ID 0339, 0341, 0365, 0383, 0408, 
0410, 0412, and 0456). The National Association of Chemical 
Distributers, in supporting the use of red borders, reasoned that they 
would be consistent with the overall goal of the

[[Page 17591]]

GHS (Document ID 0341). Additionally, the AIHA stated that 
requiring red borders would promote the safe use of chemicals (Document 
ID 0365).
    Several commenters raised economic concerns, suggesting that 
because red ink is more expensive, the use of black borders should be 
permitted (Document ID 0318, 0328, 0370, 0377, 0382, 0393, and 
0411). Dow Chemical, Troy Corporation, and several other commenters 
recommended that red borders should only be required on products that 
were being exported (Document ID 0352, 0353, 0399, 0405, and 
0389). Similarly, API argued that in order to remain consistent with 
the GHS, OSHA should only require exported chemicals to have a red 
border (Document ID 0376).
    OSHA finds this argument to be unpersuasive. In order to reap the 
benefits of consistency in warnings, labels must have a degree of 
sameness and that includes the colors used. Moreover, OSHA analyzed the 
impact that the use of red borders would have on production costs. 
While the use of red borders may increase the cost of printing, OSHA 
has determined that the cost does not render the rule infeasible. This 
issue is discussed in greater detail in Section VI. Finally, the GHS 
does not even state a preference for black borders on labels of 
domestic products; it simply gives the competent authority discretion 
to allow black borders when the product will not enter into 
international commence.
    Numerous studies have found that substantial benefits exist when 
color is used on labels. Due to the extensive amount of information 
that needs to be displayed, warning labels can become cluttered. 
Swindell found that searching for needed information on a cluttered 
label is very challenging for the user (Swindell, 1999, Document ID 
0284). Her study concluded that minor changes to an extensive 
warning label, such as the addition of color, can greatly improve the 
noticeability of the warning, grab the attention of the user faster, 
and produce quicker reaction times.
    Swindell also researched the effect that different colors (red, 
blue, and black) had on the time it took users to locate and respond to 
a warning. Red was perceived to indicate the highest degree of hazard 
and was shown to increase the perceived hazard of a word presented in 
that color (e.g., DANGER in blue is perceived as less hazardous than 
WARNING in red).
    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, 
Document ID 0281). These studies involve color on label 
elements other than the pictogram borders, but the presence of color 
and the particular color is germane to the red borders of labels.
    The primacy of red as an understandable color denoting danger is 
also supported by these studies.
     Smith-Jackson and Wogalter asked English-speaking 
community members to rate the perceived hazard of ten ANSI safety 
colors (Smith-Jackson and Wogalter, 2000, Document ID 0196). 
Red, yellow, black, and orange were rated the highest (in descending 
order). Differences were statistically significant except the 
difference between yellow and black.
     Among 80 college students asked to rate colors by Griffith 
and Leonard, red was rated the most ``meaningful'' color (i.e., most 
distinct in meaning from neutral gray), followed by green, orange, 
black, white, blue, and yellow (Griffith and Leonard, 1997, Document ID 
0250).
     Wogalter et al. asked Spanish speakers to rank the 
perceived hazard of ANSI safety colors (Wogalter et al., 1997b, 
Document ID 0266). Red was ranked highest, followed by orange, 
black, and yellow.
     Dunlap et al. surveyed 1169 subjects across several 
different language groups including English, German, and Spanish 
speakers (Dunlap et al., 1986, Document ID 0191). Subjects 
rated the color words red, orange, yellow, blue, green, and white 
according to the level of perceived hazard. The results demonstrated 
that the hazard information communicated by different colors followed a 
consistent pattern across language groups, with red having the highest 
hazard ratings.
     Wogalter et al. asked undergraduates and community 
volunteers to rank various warning components (Wogalter et al., 1998, 
Document ID 0286). Red connoted a significantly greater hazard 
than other colors, followed by yellow, orange, and black (in that 
order). A group of industrial workers ranked the colors from greatest 
to least hazard as follows: red, yellow, black, orange.
     London asked workers in four sectors in South Africa to 
rank the colors red, yellow, green, and blue in terns of perceived 
hazard; 95 percent said red represents the greatest hazard, and 58 
percent said yellow is the second greatest hazard (London, 2003; 
Document ID 0311).
     Banda and Sichilongo asked workers in Zambia to rate the 
perceived hazard of various colors used in chemical labels (Banda and 
Sichilongo, 2006, Document ID 0237). Red was associated with 
the greatest hazard, followed by yellow.
     Among a sample of 30 undergraduates who rated the 
perceived hazard of 105 signal word/color combinations, Braun et al. 
reported that red conveyed the highest level of perceived hazard 
followed by orange, black, green, and blue (Braun et al., 1994, 
Document ID 0298).
    These reports are consistent in showing that red is commonly 
understood to be associated with a high level of hazard--the highest of 
any color.
    After reviewing stakeholder comments and studies investigating the 
benefits of using the color red to signal a hazard, OSHA has decided to 
require all pictograms to have red borders. OSHA finds that these 
labels will be more effective in communicating hazards to employees--
both by drawing the attention of employees to the label and by 
indicating the presence of a hazard through non-verbal means. 
Consistently applying red borders to all labels, regardless of the 
final destination, will ensure that workers are protected. OSHA has 
determined that red pictogram borders will maximize recognition of the 
warning label and ensure consistency; therefore the final rule requires 
red borders for both domestic and international labeling.

Blank Diamonds

    The final rule requires that all red diamonds printed on a label 
have one of the eight pictograms printed inside the diamond. The 
prohibition of blank diamonds on labels will ensure that users do not 
get desensitized to warnings placed on labels. Two commenters proposed 
alternatives to the prohibition of blank diamonds. The American 
Chemical Council (ACC) suggested that, because the red diamond border 
for pictograms are often pre-printed on shipping labels, OSHA allow 
printing the word ``BLANK'' on, or writing ``pictogram intentionally 
left blank'' in, the unused diamond (Document ID 0393). 
Additionally, Michelle Sullivan also suggested writing ``intentionally 
left blank'' in the empty diamonds (Document ID 0382).
    OSHA acknowledges that prohibiting blank diamonds on labels may 
require an adjustment in practice for entities that use pre-printed 
labels or require businesses to inventory additional blank stock. OSHA 
analyzed the impact that prohibiting the use of blank diamonds on 
labels would have on production costs. While this requirement may

[[Page 17592]]

increase costs associated with labeling, OSHA has determined that the 
costs do not render the rule infeasible. This issue is discussed in 
greater detail in Section VI.
    Including diamonds on labels only when a pictogram is required will 
ensure that such warnings stand out to users. Prohibiting the use of 
blank diamonds will improve the likelihood that users will notice and 
react to the warning on the label. Therefore, OSHA has determined that 
prohibiting the use of blank diamonds on labels is necessary to provide 
the maximum recognition and impact of warning labels and to ensure that 
users do not get desensitized to the warnings placed on labels.

Hazard Statements 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. This revised rule replaces the current 
performance-oriented requirement for ``appropriate hazard warnings'' on 
labels with a requirement for specific hazard and precautionary 
statements on labels. The statements are prescribed, based on the 
hazard classification of the chemical.
    Standardized requirements for hazard and precautionary statements 
provide a degree of consistency that is lacking among current chemical 
labels. This lack of consistency among current labels makes it 
difficult for users to understand the nature and degree of hazard 
associated with a chemical, and to compare chemical hazards. For 
example, in an article reviewed for the record, Dr. Beach relates 
experiences from the perspective of a doctor treating occupationally 
exposed patients (Beach, 2002, Document ID 0238). 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, Hazardous Industrial Chemicals--Precautionary 
Labeling (Document ID 0610), 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, not all chemical manufacturers and 
importers have adopted the ANSI approach. As a result of the diverse 
formats and language used in the past, a consistent and understandable 
presentation of information was not fully achieved.
    A preference for hazard statements was shown in EPA's Consumer 
Labeling Initiative (Abt Associates, 1999, Document ID 0209). 
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 provides 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, Document ID 0191). 
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 indicate 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, Document ID 0246). 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, Document ID 0249).
    Explicit precautionary statements 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, Document ID 0246). 
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 revised rule 
eliminates the need for users to infer protective actions.
    Evidence indicates that using key label elements together improves 
warning performance, compared with labels that only contain a subset of 
these elements. This is the approach taken in the revised rule, which 
requires 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, American 
National Standard for Product Safety Signs and Labels); and warnings 
with text only (Meingast, 2001, Document ID 0246). 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, 
Document ID 0258). 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, Document ID 0287). 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,

[[Page 17593]]

Document ID 0281). Laughery et al. tested warnings to 
determine which elements influenced notice ability. The authors 
manipulated labels by adding a pictorial, adding an alert symbol with a 
signal word, making the text red, and/or adding a border around the 
warning. The warning was located fastest when all four of these 
modifications were present, suggesting that the best designs include a 
combination of enhancements.
    The findings of these reports support OSHA's belief that the 
combined label elements, i.e., pictogram, signal word, hazard and 
precautionary statements, is 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 warnings required in this final 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 improves understanding.
    Overall, the record shows that 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 
0032, 0054, 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.

    The majority of comments received in response to the proposal 
support the use of hazard and precautionary statements on labels (See, 
e.g., Document ID 0313, 0324, 0327, 0328, 0329, 0330, 0335, 
0336, 0338, 0339, 0344, 0347, 0349, 0351, 0352, 0353, 0365, 0370, 0372, 
0376, 0377, 0379, 0381, 0382, 0383, 0389, 0393, 0399, 0402, 0405, 0408, 
0410, 0412, 0453, 0456, and 0461). No comments or testimony were 
received that opposed the use of hazard or precautionary statements on 
labels or safety data sheets.
    In response to the proposal, stakeholders commented on the 
importance of being able to comprehend hazard and precautionary 
statements (See, e.g., Document ID 0321, 0339, 0349, 0410, and 
0412). Morganite Industries, Inc. and Morgan Technical Ceramics USA 
stated: ``Hazard Statements, by and large, convey fact in simple 
language'' (Document ID 0321). Commenting on the use of 
precautionary statements, the Phylmar Group noted that ``clear, concise 
use of key labeling elements can improve warning performance'' 
(Document ID 0339). The American Industrial Hygiene 
Association also supports the use of precautionary statements, stating 
that they ``should improve comprehensibility and compliance'' (Document 
ID 0410).
    Labels are intended to provide an immediate visual reminder of 
chemical hazards. Whereas labels in the past could be presented in a 
variety of formats using inconsistent terminology and visual elements, 
labels prepared in accordance with the requirements in this final rule 
will be consistent. Standardized signal words and hazard statements 
attract attention and communicate the degree of hazard. Pictograms 
reinforce the message presented in text and enhance communication for 
low-literacy populations. Precautionary statements provide useful 
instructions for protecting against chemical-source injuries and 
illnesses.
    A number of stakeholders submitted comments in support of 
standardized labeling for hazardous chemical containers. Several 
commenters stated that standardized label elements would better convey 
critically important hazard warnings, and provide useful information 
regarding precautionary measures that would serve to better protect 
employees (Document ID 0313, 0341, 0344, 0365, 0381, 0382, 
0402, and 0405). The studies contained in the record reinforce OSHA's 
position on the use standardized label elements--including the use of 
standardized pictograms, signal words, and hazard and precautionary 
statements--to alert and inform chemical users of the hazards posed by 
hazardous chemicals in the workplace.
    OSHA concludes, based on the studies discussed above and supported 
by the comments submitted to the record that standardizing the labels 
for hazardous chemicals is an essential step in harmonizing the HCS 
with the GHS. In addition, OSHA concludes that the labeling 
requirements in this revised final rule will result in more effective 
transmittal of information to employees. Therefore, OSHA has adopted 
the labeling requirements set forth in the NPRM in this final rule.

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. Prior to this final standard, the 
information was not required to be presented in any particular order or 
to follow a specific format.
    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. In the NPRM, OSHA proposed requiring the 
information on SDSs to be presented using consistent headings in the 
sequence specified in the GHS (See Section XV for a detailed discussion 
of the requirements). The Agency has determined that a standardized 
order of information will improve the utility of SDSs by making it 
easier for users to locate and understand the information they are 
seeking. A standardized format is also expected to improve the accuracy 
of the information presented on SDSs.
    Since the HCS was promulgated in 1983, access to chemical 
information has improved dramatically due to the availability of SDSs. 
OSHA believes that adopting a standardized format will build on the 
demonstrated benefits that have already clearly been established from 
the use of SDSs. As discussed in the proposal, the General Accounting 
Office (GAO) issued a report in May 1992 that addressed issues 
employers had with complying with the HCS (GAO, 1992, Document ID 
0292). The findings were based on the results of a national 
survey of construction, manufacturing, and personal services

[[Page 17594]]

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.
    Conklin demonstrated the utility of SDSs among employees of a 
multinational petrochemical company (Conklin, 2003; Document ID 
0245). 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 that this 
sample did not include any workers with low literacy.
    However, while these studies show a clear benefit related to the 
use of SDS in the workplace, a number of investigations raise concerns 
that 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, 1991a, 1991b, 
Document ID 0309 and 0310). The study assessed the ability of 
these employees to understand information regarding the route of entry 
of the substance, the type of health hazard present, appropriate 
protective measures, and sources of additional help.
    Each of the 91 participating workers was provided with and tested 
on four different SDSs. The workers answered the test questions based 
on information supplied on each of the SDSs. It should be noted that 
the employees who volunteered for this study understood that it relied 
on reading comprehension. This created a selection bias, as employees 
with reading difficulties would not be likely to volunteer for the 
study.
    The results of the tests indicated that workers on average 
understood about two-thirds of the health and safety information on the 
SDSs. The best comprehension was associated with information providing 
straightforward procedures to follow (e.g., in furnishing first aid, 
dealing with a fire, or in using personal protective equipment) or 
descriptions of how a chemical substance can enter the body. Workers 
had greater difficulty understanding health information addressing 
different target organs, particularly when more technical language was 
used. Workers also reportedly had difficulty distinguishing acute from 
chronic effects based on information presented in the SDSs.
    Conklin reported a similar result in a study involving employees of 
a multinational petrochemical company (Conklin, 2003, Document ID 
0245). 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.
    The Printing Industries of America reported a study that examined 
the comprehensibility of SDSs to master printers in 1990 (PIA, 1990, 
Document ID 0295). 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, 
Document ID 0212). 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, Document ID 0263). 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, Document ID 0188). 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 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

[[Page 17595]]

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 (Hanson, 2004, 
Document ID 0200):

    * * * 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.

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.
    The first attempt to establish a format for SDS was made in 1985, 
when OSHA established a voluntary format to assist manufacturers and 
importers who desired some guidance in organizing SDS information. This 
two-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. In 2004, an updated version of the ANSI standard that was 
consistent with the GHS format was published. This ANSI standard has 
since been combined with the ANSI Z129 consensus standard on 
precautionary labeling preparation. The ANSI Z400.1/Z129.1 standard was 
issued in 2010.
    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, Document ID 0191). 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 (id.). 
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, Document ID 0191). 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, Document ID 
0263). 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:
    [ssquf] The ICSC performed better than the OSHA form regarding 
chronic and immediate health effects.
    [ssquf] The other two formats performed better than the ANSI format 
on fire-related questions.
    [ssquf] The OSHA form performed better than the other two formats 
on spill response questions.

[[Page 17596]]

    [ssquf] The OSHA form performed better than the ANSI format 
regarding carcinogenic potential.
    The ANSI Z400.1 template has been used by a wide number of 
employers for creating SDSs. 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.
    The ANSI format is commonly used. However, because it is a 
voluntary standard, not all chemical manufacturers and importers have 
adopted it. As a result, different formats are still used on many SDSs. 
Of the comments received regarding SDS, none were in favor of allowing 
voluntary adoption of the SDS format. The California Industrial Hygiene 
Council (CIHC) (Document ID 0463) reiterated its support for a 
uniform format, and specifically the implementation of the ANSI format 
for SDSs. The CIHC also stated that a mandatory format would establish 
a harmonized structure for all ``global target audiences'' (Document ID 
0463).
    In a separate comparison, Conklin also found similarities in the 
overall performance of several standard SDS formats (Conklin, 2003, 
Document ID 0245). 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).
    OSHA also examined several studies addressing what sequence of 
information would prove to be most beneficial for users. 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; Document ID 0188). The authors 
found a few consistent results:
    [ssquf] Information about health hazards, protective equipment, and 
fire and explosion data tended to be placed toward the beginning.
    [ssquf] Physical and reactivity data tended to be placed near the 
end.
    [ssquf] 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, 1991a, 
1991b, Document ID 0309 and 0310). While the results indicated 
that workers on average understood about two-thirds of the health and 
safety information on SDSs, ICSCs provided better results. The average 
ICSC test score ranged from 6% to 23% higher than the average test 
score on the four SDSs evaluated. This finding was considered by the 
authors to suggest that an improved format for SDSs may serve to 
increase user comprehension of the information presented.
    OSHA believes that a standardized format will improve the 
effectiveness of SDSs for the following reasons: A consistent format 
makes it easier for users to find information on an SDS. Headings for 
SDS sections are standardized, so SDS users know which section to 
consult for the information they desire. The sections are 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) is presented in the 
beginning of the document for easy reference. More technical 
information (e.g., Stability and Reactivity; Toxicological Information) 
is presented later.
    Specifically, the revised SDS format now segregate more complex 
information from information that is generally easier to understand. 
This order of information places basic information in the first 
sections, allowing SDS users to find basic information about hazardous 
chemicals 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.
    Several stakeholders expressed dissatisfaction with the degree that 
current SDSs vary from manufacturer to manufacturer (Document ID 
0330 and 0351). The International Brotherhood of Teamsters 
stated that the quality and usefulness of SDSs has been grossly 
inconsistent in terms of content and format, adding that such 
discrepancies ultimately result ``in a failure to achieve the objective 
of the standard'' (Document ID 0357). John Schriefer, head of 
Local 9477, indicated that workers often didn't bother to request SDSs, 
because they are so complicated (Document ID 0494 Tr. 54-55). 
He suggested that a simplified, standard format for SDSs would go a 
long way toward improving worker safety (Document ID 0494 Tr. 
63).
    Commenters supported putting information targeted to the employees 
first on the SDS in order to improve how emergency situations are 
addressed (Document ID 0332, 0386 and 0414). Stericycle, Inc. 
supported placing hazard identification information in one location 
rather than ``sprinkling it through the documents, as is sometimes the 
case with [SDSs]'' (Document ID 0338). United Steelworkers 
stated that the difficulty in locating information on current SDSs ``is 
bad enough with routine assessments, but in an emergency situation like 
a spill, splash or fire it can be deadly'' (Document ID 0402). 
Additionally, the American Wind Energy Association argued that 
requiring hazard identification and first aid information to be placed 
in the first sections of the SDS would serve to ``better assist 
emergency response teams to more efficiently recognize hazards during 
incidents'' (Document ID 0386). American Federation of State, 
County and Municipal Employees (AFSCME) also supported the adoption of 
a standardized SDS, reasoning that it would enable workers to better 
understand SDSs, and could ultimately lead to faster responses as well 
as a reduction in the number of incidents altogether (Document ID 
0386).

[[Page 17597]]

    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 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, researchers 
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, Document ID 0296). 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 (Kearney/Centaur, 1991a, 1991b, Document ID 
0309 and 0310). The study examined information presented in 
five areas considered crucial to the health of workers potentially 
exposed to hazardous substances. The 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, Document ID 0302). 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, Document ID 
0257). 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 ensure accuracy will 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 will be able to more efficiently examine SDSs 
when conducting inspections. The detailed entries for SDSs are 
particularly noteworthy in this regard. The sub-headings 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 final rule provides a list of 18 
properties for Section 9 of the SDS. The party preparing the SDS must 
either include the relevant information for these entries, or indicate 
that the information is not available or not applicable. This approach 
provides 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.
    Additionally, several stakeholders agreed that standardization 
would result in improved accuracy of the information on SDSs. For 
example, Ecolab, Inc. stated that a uniform approach to hazard 
classification and labeling would improve the accuracy of the 
information presented on labels and SDSs and reduce ``the currently 
observed variability among suppliers in chemical classification and 
presentation of that information'' (Document ID 0351). 
Additionally, American Iron and Steel Works noted that ``standardized 
criteria to evaluate and communicate hazards via SDSs * * * should 
assure consistent communication and lower the likelihood of 
miscommunication and misinterpretation'' (Document ID 0408). 
Alliance for Hazardous Materials Professionals also indicated that the 
standardization of SDSs is likely to ``resolve language and content 
inconsistencies among similar product providers'' (Document ID 
0327).
    OSHA concludes that the classification criteria included in the 
final rule will also improve the accuracy and precision of information 
on SDSs. The detailed criteria provided will 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 will play an important role in increasing 
the usefulness of SDSs under the final rule. By including the 
classification of the substance on the SDS, employers will be in a much 
better position to compare the hazards of different chemicals. Hazard 
categories generally give an indication of the severity of the hazard 
associated with a chemical. For example, all other things being equal, 
a chemical classified for skin corrosion/irritation in category 1 as a 
skin corrosive would be more hazardous than a chemical classified in 
category 2 as a skin irritant. If chemicals are classified into hazard 
categories, this information can be used to simplify the process of 
comparing chemicals. As noted previously, employers use SDSs as a means 
of comparing chemical hazards to select less hazardous alternatives. 
Thus, it is reasonable to conclude that this final rule will result in 
more effective use of the SDS as an instrument for identifying less 
hazardous substitutes for hazardous chemicals.
    Stakeholders have expressed support for a standard SDS format. The 
development of an industry consensus standard for preparation of SDSs, 
ANSI

[[Page 17598]]

Z400.1, in itself, shows a desire on the part of many parties for a 
consistent approach to SDSs. The final rule follows the same section 
and sequence as the ANSI Z400.1, which was updated in 2004 and combined 
with the ANSI 129 standard in 2010.
    A report drafted by the GAO recommended that OSHA clearly specify 
the language and presentation of information on SDSs (GAO, 1991, 
Document ID 0292). 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, Document ID 0260).
    Comments received in response to the ANPR indicated widespread 
support for a standard format for SDS (See, e.g., Document ID 
0030, 0054, 0064, 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).
    Moreover, stakeholder response to the NPRM also overwhelmingly 
supported requiring a consistent, standardized format for SDSs 
(Document ID 0307, 0313, 0321, 0322, 0328, 0329, 0330, 0335, 
0341, 0344, 0349, 0352, 0357, 0365, 0372, 0374, 0381, 0382, 0383, 0386, 
0389, 0392, 0393, 0403, 0404, 0405, 0410, 0415, 0456, and 0463). 
American Subcontractors of America stated that a standardized format 
would make SDSs a more effective resource and better educational tool 
(Document ID 0322). Additionally, the Communications Workers 
of America asserted that standardizing SDSs would be an invaluable 
solution for addressing current inconsistencies and quality issues on 
SDSs (Document ID 0349).
    Based on the studies and comments in the record, OSHA has concluded 
that not only will the standardized SDS format indirectly improve the 
quality of information provided on SDSs, but that it is in the format 
that stakeholders already know and overwhelmingly prefer.

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 they need to follow. The final rule includes a relatively 
minor revision to the existing HCS training requirements for employers 
to train employees on the label elements and SDS format. This revision 
is intended to ensure that labels and SDSs are adequately explained to 
employees (See Section XIII for a detailed discussion of the training 
requirements). In light of the evidence discussed and new information 
submitted to the record related to label and SDS comprehension, the 
importance of training should not be underestimated.
    Training is necessary to ensure that employees understand the 
standardized headings and sequence of information on SDSs. Likewise, 
employees must be able to understand the meaning of the 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'' 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 some of 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 (Document ID 
0276), contains a test method for determining the 
effectiveness of a pictogram. The criterion for a successful, effective 
pictogram 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 (Document ID 0255). 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, Document 
ID 0288). 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, Document ID 0246; Lesch, 2003, 
Document ID 0282). 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, Document ID 0311). 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 GHS 
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. 
Banda and Sichilongo reported a similar result 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, Document ID 0237). 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

[[Page 17599]]

``flame'' symbols--which were reported to be easily confused--and other 
symbols that may generate critical confusion (London, 2003, Document ID 
0311).
    NIOSH, in its post-hearing comments, provided the following 
additional studies. These studies support OSHA's position that training 
ensures the understanding of standardized label elements (pictograms, 
signal words, hazard statement, and precautionary statements) and is an 
essential part of an effective hazard communication program.
    Burt et al. (1999, Document ID 0480.1) conducted an 
ergonomic study of correct lifting posture. The project included three 
separate studies: using 135 undergraduate students, Study 1 consisted 
of a questionnaire to evaluate nine symbols to select the most 
appropriate symbols to encourage correct lifting posture. Four of the 
symbols used in Study 1 met the appropriateness criteria and were used 
in Study 2 by 21 city council workers to test their understanding of 
each symbol. Using 100 random subjects, Study 3 was a field test that 
examined the effect of the best performing symbol (from Study 2) on 
subjects when asked to lift a box. Burt et al. found that once trained 
on the meaning of a label, the presence of a standard recognized label 
prompted the test subject to take the proper action. The author also 
found significant increases in correct lifting posture when a symbol 
was present compared with a control condition in which people were 
trained in correct lifting techniques, but did not see the symbol as a 
reminder.
    In 2007, Lesch (Document ID 0480.3) conducted a study 
looking at different training conditions. During the training, warning 
symbols with labels (to better explain the meaning of the symbol) were 
paired with accident scenarios. The accident scenarios illustrated the 
nature of the hazard, the required or prohibited actions, and the 
possible consequences of failing to comply with the warning. The 
participants were tested before and following the training (immediately 
after and two weeks later). The results showed the benefits of 
training--improved comprehension, reduced reaction times, and an 
improved confidence in their responses--and illustrated that, by 
strengthening the connections between the warning symbol and its 
associated meaning, accident scenario training can be used to prevent 
accidents and injuries.
    In 2007, Su and Hsu (Document ID 0480.5) tested 1,000 
college students on their perception of GHS labels and traffic safety 
signs. The study found that students who had taken training did better 
in perceiving various traffic safety signs than those who did not. With 
regards to chemical labeling, students who had taken hazard 
communication training had better perception ratings than those without 
training. Analysis showed that 17 out of 27 hazards had perception 
ratings lower than 66%, the ISO suggested acceptable rate for a good 
sign. The statistical analysis used in the study indicated that 
pictograms should not be used alone but accompanied by warning 
statements or other kinds of textual materials. The study also 
suggested that training on pictograms and warning statements should be 
integrated into school curriculum.
    Rother (2008, Document ID 0480.4) conducted a study to 
assess how South African farm workers interpret the pictograms used in 
the pesticide industry. Administered to 115 farm workers from 
commercial vineyards in Western Cape, South Africa, this study used a 
questionnaire designed to interpret the workers' understanding of 10 
pictograms commonly used in the pesticide industry. Fifty percent or 
more of the study participants had misleading, incorrect, or critically 
confused interpretations of the label pictograms. The study identified 
a response as critically confused when a farm worker incorrectly 
interpreted a pictogram to require an action or behavior that would 
increase his or her health risks. OSHA agrees with NIOSH's 
interpretation that the study ``found that lack of training severely 
affected farm worker's abilities to correctly interpret pesticide 
pictogram warning labels'' (Document ID 0470).
    These reports 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) (Document ID 0277), for example, 
recommends training on the meaning of standard safety symbols and 
signal words, and ANSI Z535.4 (Document ID 0278) contains 
similar guidance.
    OSHA received many comments supporting the importance of training 
(See, e.g., Document ID 0329, 0331, 0347, 0370, 0382, 0387, 
0412, 0527, 0640, 0644, and 0647). The National Institute of 
Occupational Safety and Health (NIOSH) (Document ID 0412) 
stated:

    Training is key to ensuring effective hazard communication. 
Although written information is 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.

    The USW stated that ``there is no question good training greatly 
improves the ability to understand chemical labeling and safety data 
sheets. Unfortunately, the OSHA standard is vague * * *'' (Document ID 
0403). Several organizations, including Western Region 
Universities Consortium, ORC Worldwide, SOCMA, NIOSH, Building & 
Construction Trades Department of AFL-CIO, NIEHS, and USW (e.g., 
Document ID 0331, 0370, 0402, 0412, 0527, 0640, and 0647) 
stated that training, though essential, is often not done well, and 
urged OSHA to ``strengthen training requirements and worker 
protection'' (Document ID 0331).
    Others, such as DuPont, API, Michelle Sullivan, ACC, and American 
Iron and Steel Institute/American Coke & Coal Chemicals Institute, 
stated that the standardized SDS and label format should facilitate 
training efforts and the overall effectiveness of hazard communication 
in industry (Document ID 0329, 0376, 0382, 0393, and 0408). 
The American Iron and Steel Institute stated: ``Standardized criteria 
to evaluate chemicals should facilitate training. With a single 
teaching format for SDSs and Labels, understanding, regardless of an 
employee's educational background, should be improved'' (Document ID 
0408).
    OSHA not only received many comments indicating that the training 
requirements in the HCS are not adequate, several organizations 
requested that OSHA either add regulatory text or a mandatory appendix 
specifying training content, frequency, and methods of evaluation 
(Document ID 0331, 0340, 0347, 0349, 0357, 0403, 0414, 0456, 
0640, and 0647). For example, the National Institute of Environmental 
Health Sciences Worker Education and Training Program (NIEHS WETP) 
(Document ID 0347 and, 0516) provided training information, 
including a training program guidance manual, and an outline detailing 
specific training topics for the HCS.
    OSHA agrees that training is important for ensuring effective 
hazard communication. However, OSHA did not propose to change the 
training provisions in the HCS other than initial training on the new 
GHS elements.

[[Page 17600]]

Similarly, the GHS discusses the importance of training, but does not 
contain specific training requirements. Since the purpose of this 
rulemaking is to align with the requirements of the GHS, OSHA did not 
propose modifications that were outside of those necessary to maintain 
alignment with the GHS. OSHA has decided to stay within the scope of 
the rulemaking and retain the proposed training provisions in the HCS 
final rule. See Section XIII for a more detailed discussion on 
training.

Conclusion

    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 (53 FR 29826, Aug. 8, 1988; 59 FR 6126, 
Feb. 9, 1994). 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 is impossible. By ensuring 
that emergency responders, physicians, nurses, industrial hygienists, 
safety engineers and other professionals have the information they 
need, the HCS reduces the likelihood of chemical source illnesses and 
injuries. Selection of appropriate engineering controls, work 
practices, and personal protective equipment is predicated upon knowing 
the chemicals that are present, the form they are present in, and their 
hazardous properties.
    In his testimony at the informal public hearings, Mr. David Irby, a 
union safety representative at the Severstal Steel Plant in Sparrows 
Point, Maryland, expressed the importance of the right to understand 
SDSs, stating that employees ``need an easy-to read format written in a 
clear, precise and understandable manner in our workplace'' (Document 
ID 0494 Tr. 55-57). OSHA agrees that employees must be able to 
read and comprehend the information presented on both labels and SDSs 
so that they can respond accordingly. Therefore, OSHA has determined 
that the provisions in this final rule--the standardized label elements 
(including pictograms, signal words, and hazard and precautionary 
statements), a standardized 16-section SDS, and the requisite training 
provisions--provide the necessary conventions to support understanding 
the hazards posed by chemicals in the workplace and that this final 
rule provides employees not only with the ``right to know'' but also 
the ``right to understand.''
    OSHA concludes that aligning the HCS with the GHS will 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 and easier to 
understand, and will 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, OSHA has determined that these revisions will 
more adequately inform employees of chemical hazards, and lead to 
better protections in the workplace.

V. 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 Congress to achieve this goal is the mandate given to, 
and the authority vested in, the Secretary of Labor to ``promulgate, 
modify, or revoke'' mandatory occupational safety and health standards. 
OSH Act Sec.  6(b), 29 U.S.C. 655(b).
    An occupational safety and health standard is defined under the Act 
as:

    [A] standard which requires conditions, or the adoption or use 
of one or more practices, means, methods, operations, or processes, 
reasonably necessary or appropriate to provide 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. Indus. Union Dep't v. 
Am. Petroleum Inst., 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 workplace in 
question would be ``unsafe'' in the sense that employees would be 
threatened with a significant risk of harm. Id.
    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 the 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 * * 
* plac[ed] the `benefit' of worker health above all other 
considerations save those making attainment of this `benefit' 
unachievable.'' Am. Textile Mfrs. Inst. Inc. v. Donovan, 452 U.S. 490, 
509 (1981) (``Cotton Dust''). Where, however, there are two equally 
effective methods of reducing significant risk to the most protective 
feasible level, OSHA must choose the less costly method. See Cotton 
Dust, 452 U.S. 490, 513 n.32; Int'l 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 emergency 
treatment, and proper conditions and precautions of safe use or 
exposure.

29 U.S.C. 655(b)(7). Section 6(b)(7)'s labeling and employee warning

[[Page 17601]]

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 that 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 section 6(b)(7) to sanction OSHA's requirements for monitoring and 
medical testing when it sets a permissible exposure limit ``in reliance 
on less-than-perfect methods.'' 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 
particularly susceptible workers before they suffered any permanent 
damage. Id. at 657-58; See also Nat'l Cottonseed Products Ass'n v. 
Brock, 825 F.2d 482, 485-87 (D.C. Cir. 1987) (upholding decision to 
retain medical monitoring requirement while revoking PEL to ``provide a 
backstop if that judgment is incorrect and this surveillance will 
protect the health of the employees'').
    In promulgating a standard under the Act, OSHA's determinations 
will be deemed conclusive if they are ``supported by substantial 
evidence in the record considered as a whole.'' OSH Act Sec.  6(f), 29 
U.S.C. 655(f). When the standard deals with toxic materials or harmful 
physical agents, OSHA must use the ``best available evidence.'' Such 
evidence 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 of material health impairment ``with 
anything approaching scientific certainty'' and that the determination 
of whether a level of 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)(2); 29 U.S.C. 655(b)(2). 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. 
Auto. Ins. Co., 463 U.S. 29, 42 (1983) (internal quotation marks and 
citations omitted).

A. Legal Authority for the Current HCS

    OSHA's Hazard Communication Standard (``HCS'') is a standard 
promulgated under the authority of sections 6(b)(5) and 6(b)(7) of the 
Act (29 U.S.C. 655(b)(5) and 655(b)(7)). See Associated Builders and 
Contractors, Inc. v. Brock, 862 F.2d 63, 67-68 (3rd Cir. 1988); United 
Steelworkers of Am. v. Auchter, 763 F.2d 728, 738 (3rd Cir. 1985); 
United Steelworkers of Am. v. Auchter, 819 F.2d 1263, 1267 (3rd Cir. 
1987). Authority for the HCS may also be found in section 8(c) and 8(g) 
of the Act, 29 U.S.C. 657(c) and 657(g). Section 8(c)(1) of the Act 
requires employers to make, keep, and preserve records regarding 
activities related to the Act and to make such records available to the 
Secretary pursuant to regulations that the Secretary may prescribe. 29 
U.S.C. 657(c)(1). Section 8(g)(2) of the Act authorizes 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).
    As a 6(b)(5) standard, OSHA was required to establish that the HCS 
would substantially reduce a significant risk of material harm. Some 
OSHA standards protect employees from exposure 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 determining 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. 
The agency 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 workplace 
exposure to hazardous chemicals. 48 FR 53280, 53282 (Nov. 25, 1983). 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. Id. 
at 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.

Id. at 53321. The U.S. Court of Appeals for the Third Circuit agreed 
that ``inadequate communication is itself a hazard, which the standard 
can eliminate or mitigate.'' United Steelworkers v. Auchter, 763 F.2d 
at 735. The Third Circuit has upheld OSHA's finding of significant risk 
as sufficient to justify the HCS on several occasions. See Associated 
Builders and Contractors, 862 F.2d at 67 (discussing the history of its 
review of the issue). OSHA reaffirmed its finding of significant risk 
in adopting revisions to the HCS in 1994. 59 FR 6126, 6136-40 (Feb. 9, 
1994).
    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, is 
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 than do downstream employers. See 48 FR at 53322 
(Nov. 25, 1983). Therefore, manufacturers and importers 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 at 
53307 (Nov. 25, 1983); 59 FR at 6132-33 (Feb. 9, 1994).
    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

[[Page 17602]]

their chemicals and foreseeable emergencies associated with those 
chemicals. 29 CFR 1910.1200(b)(2).
    In previous rulemakings, OSHA rejected suggestions that the hazard 
assessment and communication 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. 48 FR at 53295, 53296, 53307 
(Nov. 25, 1983; 59 FR at 6132 (Feb. 9, 1994). 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. See 
Durez Div. of Occidental Chem. Corp. v. OSHA, 906 F.2d 1, 3-4 (D.C. 
Cir. 1990); General Carbon Co. v. OSHRC, 860 F.2d 479, 484-85 (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, the 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.'' 29 U.S.C. 
655(b)(7). 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 ensures that employers and 
employees have the information they need to avoid situations of 
exposure in the workplace even before the employee is exposed to a 
hazardous chemical. As OSHA explained in the preamble to the 1994 HCS 
amendments: ``OSHA has concluded that imposing informational 
requirements is necessary and appropriate to protect workers even when 
OSHA has not determined that the level of risk at a particular worksite 
warrants a substance-specific standard that would employ more elaborate 
types of controls.'' 59 FR at 6132 (Feb. 9, 1994).

B. Authority for the Final Rule

    1. Section 6(b)(7) Authority. OSHA has authority to adopt the 
revisions to the HCS made in the final rule under the last sentence of 
section 6(b)(7) of the Act, which provides that:

    The Secretary, in consultation with the Secretary of Health and 
Human Services, may by rule promulgated pursuant to section 553 of 
title 5, 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).
    This provision exempts modifications to hazard communication, 
monitoring, and medical examination requirements from the standard-
setting requirements of section 6(b), and so evidences Congress's 
intent to provide OSHA with an expedited procedure to update these 
requirements. OSHA believes that exercise of this authority does not 
require a new finding of significant risk. As noted above, the 
``backstop'' 6(b)(7) requirements of hazard communication, exposure 
monitoring, and medical surveillance may be imposed even in the absence 
of a significant risk finding. See Benzene, 448 U.S. at 657-58; Nat'l 
Cottonseed Products Ass'n, 825 F.2d at 485-87. The last sentence of 
section 6(b)(7) merely allows these requirements to be updated to 
reflect the latest knowledge available. The authorization to use 
Administrative Procedure Act notice and comment procedures rather than 
the more elaborate framework established by section 6(b) demonstrates 
congressional intent to treat such modifications differently from 
rulemakings to adopt standards. Congress envisaged a simple, expedited 
process that is inconsistent with the idea that OSHA must undertake 
additional significant risk analyses before exercising this authority.
    Rather than requiring a finding of significant risk, the last 
sentence of section 6(b)(7) provides other assurances that OSHA is 
exercising its authority appropriately: by requiring the involvement of 
the Secretary of Health and Human Services, and by limiting the 
authority only to modifications that are based on ``experience, 
information, or medical or technological developments'' acquired since 
the promulgation of the standard in the limited areas of hazard 
communication, monitoring, and medical examinations. Therefore, OSHA 
need not make any new significant risk findings; rather, the final rule 
is supported by the significant risk findings that OSHA made when it 
adopted the current HCS.
    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 (Jan. 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 
at 33458 (June 18, 1998). 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 
that the survival rates when semi-annual x-rays were used were not 
higher than when annual exams were administered. 63 FR at 33458-59 
(June 18, 1998). In addition, OSHA has used its section 6(b)(7) 
authority to authorize new respirator fit protocols under its 
respiratory protection standard. 69 FR 46986 (Aug. 4, 2004); See 
generally 29 CFR 1910.134 App. A, Pt. II. On neither occasion has OSHA 
made new findings about significant risk.
    The final rule fits well within the authority granted by the last 
sentence of section 6(b)(7). Adoption of GHS provisions constitutes 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 is ``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 Parts III and XIII of 
this preamble; 74 FR 50280, 2085-86 (Sept. 30, 2009); 71 FR 53617, 
53618-19 (Sept. 12, 2006). Indeed, OSHA noted the possibility of a 
future

[[Page 17603]]

internationally harmonized standard in the preamble accompanying the 
original HCS rule. See 48 FR at 53287 (Nov. 25, 1983).
    The last sentence of section 6(b)(7) also requires consultation 
with the Secretary of Health and Human Services. As detailed in the 
NPRM, NIOSH was involved in the development of the proposal through 
briefings and review of the proposed rule before publication. See 74 FR 
at 50306 (Sept. 30, 2009). NIOSH strongly supported the proposal in 
comments and hearing testimony (Document ID 0412, 0470, 0472, 
and 0497) and has actively supported the development of the GHS. See 74 
FR at 50306 (Sept. 30, 2009).
    Paul A. Shulte, Ph.D., testified on behalf of NIOSH that:

    [A] significant advantage of the proposed standard is the 
detailed technically sound criteria for classification that will 
improve accuracy and consistency in the information provided to 
employers and employees on chemical hazards and protective measures 
* * *. In summary, the proposed standard will serve as a powerful 
tool for the protection of working people.

(Document ID 0497 Tr. 36-37). OSHA has consulted with HHS in 
accordance with section 6(b)(7). 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).
    2. Section 6(b)(5) Authority. OSHA also has authority to adopt the 
proposal under section 6(b)(5) of the Act, 29 U.S.C. 655(b)(5). As 
noted above, section 6(b) explicitly allows OSHA to ``modify'' 
standards, and adoption of the GHS is justified because it ``most 
adequately assures'' employee protection for purposes of section 
6(b)(5) for the reasons detailed in parts IV and XIII of this preamble.
    HCS is a 6(b)(5) standard since it acts to mitigate the significant 
health risk of using dangerous chemicals without adequate hazard 
communication. See Int'l Union, UAW v. OSHA, 938 F.2d 1310, 1313 (D.C. 
Cir. 1991). The Society of the Plastics Industry, Inc. (SPI), however, 
argues that because the rule also addresses physical hazards, ``the 
agency must comply with the more demanding burden of proof at least 
with respect to the safety hazards,'' and that some form of cost-
benefit analysis is required (Document ID 0392). OSHA 
disagrees. Safety standards must be ``highly protective,'' which means 
OSHA may ``deviate only slightly from the stringency required by 
section 6(b)(5).'' Int'l Union, UAW v. OSHA, 37 F.3d 665, 669 (D.C. 
Cir. 1994). The burden of proof for safety standards is therefore not 
more demanding than that required for 6(b)(5) standards, as SPI argues. 
Nor does OSHA believe that the OSH Act requires a cost-benefit analysis 
in setting safety standards. See Control of Hazardous Energy Sources, 
Supplemental Statement of Reasons, 58 FR 16612, 16621-23 (Mar. 30, 
1993). However, as discussed in Section VI, Final Economic Analysis, 
OSHA has examined the costs and benefits of the final rule, and found 
that the benefits exceed costs by a large margin. In any event, OSHA 
believes that the more protective requirements of section 6(b)(5) apply 
to this standard because the standard addresses health hazards.
    Standards adopted under the authority of section 6(b)(5) must be 
supported by a finding of significant risk. However, as explained 
elsewhere, the GHS is an improved method of communicating chemical 
hazards to employers and employees over the current standard, and 
therefore the final rule, which incorporates the GHS, is now the 
``standard that most adequately assures'' worker protection. OSH Act 
Sec.  6(b)(5); 29 U.S.C. 655(b)(5). Adoption of GHS will substantially 
reduce the significant risk of inadequate communication workers face. 
As discussed above, OSHA supported the current rule with a finding, 
affirmed by the Third Circuit, that ``inadequate communication about 
serious chemical hazards endangers workers'' and that the HCS will 
mitigate this risk. 48 FR 53321 (Nov. 25, 1983); United Steelworkers v. 
Auchter, 763 F.2d at 735; See also 59 FR 6126, 6127, 6129, 6132-38 
(Feb. 9, 1994). The record shows that this significant risk of 
inadequate communication was not eliminated by the current standard.
    As discussed in Section IV, several studies show that employees do 
not understand approximately one-third of the safety and health 
information listed on SDSs prepared in accordance with the current 
standard (Document ID 0245, 0263, 0295, 0309, and 0310). 
Studies also report that roughly 40% of persons reviewing SDSs found 
them difficult to understand (Document ID 0188 and 0262). The 
results from these studies probably overstate the level of 
comprehension in the workforce, because the studies had a selection 
bias towards employees who have stronger English reading skills. These 
findings are corroborated by worker testimony stating that they and 
their coworkers find SDSs ``difficult and confusing,'' ``inadequate and 
incomprehensible,'' and a ``nightmare.'' One witness stated that 
employees he works with would not ask to see SDSs because they were too 
complicated, and as a result, the employees unwittingly expose 
themselves to chemical hazards (Document ID 0494 Tr. 50, 54-
55; and 0499 Tr. 134, 147-48, 151, 162, 165-66, and 167).
    Moreover, the evidence in the record shows workers who read SDSs 
prepared in a standardized format have substantially improved 
comprehension of the information they present (Document ID 
0191, 0263, 0309, and 0310). Indeed, standards specifying 
uniform formats for SDSs have been adopted by ANSI and other standards 
bodies, indicating a consensus that standardized SDSs will more 
effectively communicate chemical hazards to workers and employers. 
Moreover, commenters overwhelmingly agreed that standardizing SDSs 
would improve hazard communication. (See, e.g., Document ID 
0330, 0335, 0336, 0341, 0344, 0348, 0357, 0370, 0372, 0376, 
0381, 0410, 0414, and 0415).
    Likewise, the record shows that the current HCS's performance-
oriented labeling requirements result in inadequate communication. 
Research conducted over the last twenty years and summarized in section 
IV of this preamble shows that use of the signal words ``Danger'' and 
``Warning,'' pictograms, red borders, and standardized hazard warnings 
and precautionary statements better convey information about chemical 
hazards. Studies show that the information conveyed by these techniques 
is better understood, especially among low literacy populations, better 
remembered, and more likely to be acted upon. Again, commenters agreed 
that the current performance-oriented labeling requirement leads to 
worker confusion, and that the standardized GHS labeling requirements 
would minimize that confusion. (See, e.g., Document ID 0313, 
0327, 0335, 0336, 0341, 0344, 0348, 0351, 0365, 0370, 0410, 0412, and 
0644.)
    Finally, employees still continue to suffer chemical-related 
injuries, illnesses and deaths. As discussed in more detail in Section 
VI, Final Economic Analysis, of the preamble, OSHA estimates that over 
40 million employees are potentially exposed to hazardous chemicals. 
BLS data show that in 2007, there were approximately 55,400 illnesses 
related to hazardous chemical exposures and 125 chemical-related 
fatalities. These statistics probably represent only a small portion of 
the illnesses experienced by exposed employees; most occupational 
illnesses are not reported because they are not recognized as being 
related to workplace exposures and are subject to long

[[Page 17604]]

latency periods between exposure and the manifestation of disease. The 
most recent nationwide study of chronic illness estimated that in 1992, 
there were between 46,900 to 73,700 fatalities from chronic illnesses 
related to occupational exposures to chemicals (Document ID 
0274). In addition, a 2004 study of chronic occupational 
illness in California reported that more than 200,000 workers were 
diagnosed with serious chronic diseases 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 (Document ID 0269).
    These data corroborate the idea that currently there is inadequate 
communication of chemical hazards in the workplace. Further, they show 
that the use of chemical hazards in the workplace creates a significant 
risk to employees. For the reasons explained above and in sections IV 
and XIII of the preamble, OSHA believes that the final rule will reduce 
the risk to employees by providing better and more easily understood 
information to employees and employers about the hazards of the 
chemicals they use, which in turn will allow precautionary measures to 
be taken.
    In its post-hearing comment, the Styrene Information and Research 
Council (SIRC) argued that OSHA should also have examined injury and 
illness rates in the EU. It states that ``the GHS is substantially the 
system that has been in place in the EU for the last 40 years'' for 
substances covered by the EU Dangerous Substances Directive and for the 
10 years for mixtures covered by the EU Dangerous Preparations 
Directive (Document ID 0642). OSHA disagrees with SIRC's 
premise. There are significant differences between the GHS and the 
relevant EU directives. These differences include the criteria for 
classifying hazards, as well as the label elements used to communicate 
the hazardous effects. In addition, even if the EU's hazard 
communications obligations were substantially similar to the GHS, there 
are technical hurdles that would have to be overcome before such a 
study could yield useful information. There are significant differences 
in the way that statistics for occupational illness and injuries 
collected by the US and the EU (and its members) that make direct 
comparisons difficult. Furthermore, the regulatory structure for 
mitigating the hazards identified and communicated in varying systems 
also differ significantly, and this would confound any effort to 
compare illness and injury rates in the two jurisdictions. In any 
event, OSHA need not wait for scientific certainty to update its 
regulations, but rather it must rely on the best available evidence, 
and may use conservative assumptions in interpreting the evidence. OSH 
Act Sec.  6(b)(5), 29 U.S.C. 655(b)(5); Benzene, 448 U.S. at 655-56 & 
n.62. As discussed above and in Sections IV and XIII, the best 
available evidence indicates that a significant risk continues to exist 
under the current standard and that the final rule will improve 
chemical hazard communications, thereby reducing the risk of injury, 
illness or death associated with the use of hazardous chemicals in the 
workplace.

C. Feasibility

    OSHA standards must be 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 Am. 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. Id. 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 at 6133 (Feb. 9, 1994). OSHA has repeatedly found that the 
requirements of the HCS are technologically feasible. See 52 FR at 
31855-57 (Aug. 24, 1987); 59 FR at 6133 (Feb. 9, 1994). While the GHS 
modifications to HCS impose more specific requirements for hazard 
classification, labeling, and safety data sheets, employers may use the 
same expertise and methods to meet these requirements as they are 
already utilizing to comply with the requirements of HCS.
    As discussed below and in section VI.E of this preamble, OSHA 
believes the final rule poses no technological feasibility issues. The 
most important resource employers will need in order 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 at 53296-99 (Nov. 25, 1983). OSHA believes that the 
availability of professionals with this expertise has only increased in 
the intervening time. The GHS has already been implemented, in whole or 
in part, by a number of major U.S. trading partners, including Japan 
and the EU. Companies that export to these jurisdictions should already 
have developed expertise in the GHS, and there are a number of GHS 
training resources developed on the international level (Document ID 
0405, 0410, and 0514). At least one professional organization 
currently provides GHS training in hazard communication to 
professionals and businesses in the United States (Document ID 
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 
0412). OSHA received numerous comments 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 0015, 0024, 0026, 0036, 
0038, 0042, 0046, 0050, 0053, 0072, 0077, 0107, 0108, 0116, 0123, 0128, 
0141, 0144, 0145, 0154, 0155, 0163, 0330, 0352, and 0389.) The Agency 
has been engaged on several fronts to facilitate the transition from 
the current standard to the GHS modifications. For instance, the United 
Nations Institute for Training and Research is developing basic and 
more advanced training courses for the GHS, and OSHA has been involved 
with and committed resources to this effort. As discussed in more 
detail below in the Summary and Explanation, OSHA plans to issue a 
number of outreach and compliance assistance materials. Additionally, 
NIOSH testified that the World Health Organization has started the 
process to convert International Safety Cards to GHS and as of March 
2010; approximately 249 (15%) have

[[Page 17605]]

already been converted (Document ID 0497 Tr. 46). OSHA 
believes that adopting the GHS modifications poses no technological 
feasibility issues.
    Likewise, for the reasons more fully discussed in Section VI, Final 
Economic Analysis, OSHA believes that the adoption of GHS will not pose 
economic feasibility issues. Again, OSHA previously found that the 
implementation of HCS would have no such effect. See 52 FR at 31855-57 
(Aug. 24, 1987); 59 FR at 6133 (Feb. 9, 1994). As discussed in Section 
VI, OSHA has found 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 and will result in 
savings for employers. 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.

VI. Final Economic Analysis and Voluntary Regulatory Flexibility 
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 Orders 12866 and 13563, 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. Executive 
Orders 12866 and 13563 direct agencies to assess all costs and benefits 
of available regulatory alternatives and, if regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety effects, 
distributive impacts, and equity). Executive Order 13563 emphasizes the 
importance of quantifying both costs and benefits, of reducing costs, 
of harmonizing rules, and of promoting flexibility. OSHA has determined 
that this action is ``economically significant'' within the meaning of 
3(f)(1) of the executive order because it is likely to have an effect 
on the economy of $100 million or more in any one year. Accordingly, 
the rule has been reviewed by OMB.
    Accordingly, OSHA has prepared this Final Economic Analysis (FEA), 
including a Final Regulatory Flexibility Screening Analysis (FRFSA), 
for the modifications to the Hazard Communication Standard (HCS). The 
OSHA FEA is based largely on research conducted for the Preliminary 
Economic Analysis (PEA) by Policy, Planning, and Evaluation, Inc. 
(PP&E), as presented in its revised final report, ``Data and Analysis 
in Support of an Economic Analysis of Proposed Changes to the OSHA 
Hazard Communication Standard,'' prepared under contract to OSHA, and 
on research conducted for purposes of completing this FEA by Eastern 
Research Group (ERG). ERG and OSHA analyses updated both costs and 
benefits. The materials prepared by PP&E, 2009 (Document ID 
0273) and ERG (2010, 2011, and 2012) \1\ are available in the 
public docket for this rulemaking, OSHA-H022K-2006-0062, through 
www.regulations.gov.
---------------------------------------------------------------------------

    \1\ Eastern Research Group (ERG, 2010). Harmonization of Hazard 
Communication: Labeling Costs. Final Report. Submitted to 
Occupational Safety And Health Administration, Directorate of 
Evaluation and Analysis, Office of Regulatory Analysis, Contract No. 
GS-10-F-0125P. April 28, 2010. Eastern Research Group (ERG, 2011). 
Harmonization of Hazard Communication: Summary of Labeling Costs. 
Final Report. Submitted to Occupational Safety And Health 
Administration, Directorate of Evaluation and Analysis, Office of 
Regulatory Analysis, Contract No. GS-10-F-0125P. March 23, 2011.
    Eastern Research Group (ERG, 2012). Excel Spreadsheets in 
Support of OSHA Final Economic Analysis for GHS Rule. Submitted to 
Occupational Safety And Health Administration, Directorate of 
Evaluation and Analysis, Office of Regulatory Analysis, Contract No. 
GS-10-F-0125P. January 20, 2012.
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Need for Regulation
    Employees in work environments covered by the HCS are exposed to a 
variety of significant hazards that can and do cause serious injury and 
death. The HCS serves to ensure 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 changes to the HCS will create a uniformity standard for the 
presentation of hazard information and, as such, will 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 IV of this 
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 revisions to the OSHA HCS will 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 revisions will 
harmonize the U.S. system with international norms, they will 
facilitate international trade.
Affected Industries
    The revisions would affect employers and employees in many 
different industries across the economy. Based on ERG (2012), OSHA 
estimates that the HCS covers over five million workplaces in which 
employees are potentially exposed to hazardous chemicals (see Table VI-
3).
    For establishments with employees whose only exposures to hazardous 
chemicals result from their use of the chemical products, the 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 judged that SDSs for imported 
chemicals would normally be produced in the country of origin, and thus 
would not represent expenses for importers. OSHA solicited comment on 
this judgment in the PEA and did not receive any contrary testimony or 
evidence.
Benefits
    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

[[Page 17606]]

estimates probably only reflect a small percentage of occupational 
illnesses (48 FR 53284, Nov. 25, 1983) 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 
(Document ID0274). 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.\2\
---------------------------------------------------------------------------

    \2\ 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.
---------------------------------------------------------------------------

    Section IV of this preamble describes some of the incidents that 
may have been related to the non-standardized approach to SDSs in the 
current HCS, including xylene exposure at a hospital when an employee 
was unable to find critical information on an SDS in an emergency spill 
situation (Document ID 0251). As a result, twelve employees 
required emergency room treatment. Were the information on SDSs more 
uniformly formatted and comprehensible, as required under the 
modifications to HCS, incidents such as this would be less likely to 
occur.
    In general, the 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 revisions to the HCS.\3\ 
The benefits associated with the current HCS may indirectly help 
provide a general sense of the potential magnitude of the benefits of 
the revisions to the HCS. OSHA estimates that if the rule could capture 
one percent of the benefits estimated for the original 1983 and 1987 
HCS rules, the 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 $250 million on an 
annualized basis.
---------------------------------------------------------------------------

    \3\ While comments in the record did not attempt to estimate the 
magnitude of these safety and health benefits, they largely 
supported the conclusion that these revisions would yield increased 
protection for workers. For additional discussion of the comments 
regarding OSHA's estimate of benefits, see Section VI:D Benefits in 
this preamble.
---------------------------------------------------------------------------

    The harmonization of hazard classifications, safety data sheet 
formats, and warning labels for affected chemicals and products would 
also yield 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 modifications to the HCS due the 
standardization of SDSs, which will make it easier to locate 
information and determine handling requirements, and other factors 
related to simplification and uniformity which will improve workplace 
efficiency.
    In 2008, in preparation for OSHA's Notice of Proposed Rulemaking, 
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 revisions to the HCS and analyzed 
the potential savings that would be realized as a result of adopting 
these revisions. Using the parameters estimated by PP&E through its 
research and employing updated data on wages and the number of affected 
establishments and employees, OSHA has concluded that the annual cost 
savings for these companies would be an estimated $507.4 million.
    OSHA also expects the revised HCS will reduce the costs of 
providing hazard communication training to employees in future periods. 
Stakeholders largely corroborated that expectation. Standardized SDS 
and label formats will reduce the amount of time needed to familiarize 
employees with the HCS, which will reduce the training time for all 
employees once the final rule is fully implemented. OSHA did not 
monetize these estimated cost savings, but anticipates that they will 
be substantial.
    As an additional benefit, the modification of the HCS by the 
inclusion of the globally harmonized system (GHS) of classification and 
labeling 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.
    Finally, the GHS modifications to the OSHA HCS would meet the 
international goals for adoption and implementation of the GHS that 
have been 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 Chemicals Management, a policy 
framework that the U.S. helped to craft (See http://www.chem.unep.ch/saicm/).
Compliance Costs
    The estimated compliance costs for the revisions to the HCS 
represent the additional costs necessary for employers to achieve full 
compliance. They do not include costs associated with current 
compliance that has already been achieved; 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 majority of the costs associated with compliance with the 
revisions to the HCS would generally be incurred by the affected 
industries as one-time transitional costs over the phase-in period of 
four years including the costs to reclassify chemical hazards and 
revise SDSs and labels, to train workers, and for management to 
familiarize itself with the requirements of the final rule. There will 
be additional ongoing annual compliance costs associated with the 
revisions to the HCS due to the cost to purchase and maintain color 
printing ink or cartridges or to purchase pre-printed color labels in 
order to comply

[[Page 17607]]

with the requirement that the GHS hazard warning pictogram be presented 
with a red border. However, OSHA's analysis has found that these costs 
will not be substantial relative to the other costs of the rule.
    The compliance costs are expressed as an annualized cost for 
purposes of assessing the cost-effectiveness of the 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. 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,\4\ to 
calculate the annualized cost.
---------------------------------------------------------------------------

    \4\ OSHA annualized costs for this rule over a 20-year period in 
accordance with Executive Order 13563, which directs agencies ``to 
use the best available techniques to quantify anticipated present 
and future benefits and costs as accurately as possible.'' In 
addition, OMB Circular A-4 states that analysis should include all 
future costs and benefits using a ``rule of reason'' to consider for 
how long it can reasonably predict the future and should limit its 
analysis to this time period. The choice of a 20-year period is 
designed to capture out-year benefits given a 4-year phase-in 
period. A shorter period would place too much emphasis on the phase-
in period, where benefits would not be accruing. A longer discount 
period might over-emphasize the long-term benefits since net 
benefits increase with the length of the annualization period. As a 
comparison, the life of OSHA's original hazard communication rule 
was 1987 to 2011, a 24-year period, suggesting that 20 years is a 
reasonable estimate.
---------------------------------------------------------------------------

    The total annualized cost of compliance with the final rule is 
estimated to be about $201 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 ($22.5 million); training for employees 
to become familiar with new warning symbols and the revised safety data 
sheet format ($95.4 million); management familiarization and other 
management-related costs as may be necessary ($59.0 million); and costs 
to purchase upgraded label printing equipment and supplies or to 
purchase pre-printed color labels in order to include the hazard 
warning pictogram enclosed in a red-bordered diamond on the product 
label ($24.1 million).
Net Benefits, Cost-Effectiveness, and Regulatory Alternatives
    Table VI-1 provides a summary of the costs and benefits of the 
modifications to the OSHA HCS, and it shows the net benefits of the 
modifications to the standard are estimated to be $556 million 
annually, using a discount rate of 7 percent to annualize costs and 
benefits. (Using a 3 percent discount rate instead would have the 
effect of lowering the costs to $161 million per year and increasing 
the gross benefits to $839 million per year. The result would be to 
increase net benefits from $556 million to $674 million per year.) 
Because compliance with the 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 more than a factor of 
three.
    In response to comments on the proposed rule, OSHA has made the 
following changes to the economic analysis from the PEA to the FEA:
    (1) Increased by 100 percent the amount of training time necessary 
to train employees on the revised HCS during the transition period--
from 30 minutes to 60 minutes;
    (2) Increased by over 60 percent the number of SDSs (with 
corresponding labels) covered by the rule--from approximately 0.9 
million to over 1.4 million;
    (3) Added annualized costs of $24.1 million to print product labels 
in color; and
    (4) Incorporated updated economic data on the number of 
establishments, number of employees, annual revenues, annual profits, 
etc. and adjusted estimates from 2007 dollars to 2010 dollars.
    The change from 2007 to 2010 dollars using the GDP deflator (for 
non-wage-related costs and benefits) increased affected costs and 
benefits by about 4 percent. The rule changes that increased the phase-
in period reduced the annualization factors and the associated costs 
and benefits by about 9.6 percent. All other changes to costs and 
benefits were the result of updated economic data, including wages, and 
revised cost factors (e.g., number of SDSs, number of affected 
employees) in response to comments on the proposed rule.
BILLING CODE 4510-26-P

[[Page 17608]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.001

BILLING CODE 4510-26-C

[[Page 17609]]

    As discussed in Section III of this preamble, the available 
alternatives to the final rule are somewhat limited since this final 
rule modifies the current HCS in order to align with the provisions of 
the UN's GHS. In Section III, the Agency qualitatively discussed the 
two major alternatives presented during this rulemaking process--(1) 
voluntary adoption of GHS within the existing HCS framework and (2) a 
limited adoption of specific GHS components and a variation on (1) that 
would require compliance with GHS but allow an exemption for small 
businesses to comply with either the current HCS or with the GHS-
compliant HCS. All of these alternatives were soundly rejected by 
stakeholders. To allow certain parties to follow an alternative system 
or to allow voluntary adoption of the elements of a uniformity standard 
does nothing to reduce confusion, improve efficiency, or simplify 
processes. In order for those benefits to be realized, all elements 
must apply to all affected parties. OSHA has determined that both of 
the alternatives presented above would eliminate significant portions 
of the benefits of the rule.
    OSHA did not attempt to evaluate the costs and benefits for the 
regulatory alternatives that involved partial or voluntary adoption of 
the GHS. The Agency did evaluate two alternatives where the effective 
dates were altered. In the first alternative considered, all elements 
of the revised HCS would be required to be implemented within two 
years. Under this alternative, all transitional costs would be incurred 
in two years and benefits would be realized beginning in the third 
year. The second alternative that OSHA evaluated extended the timeline 
for training to be completed. For this alternative, all elements of the 
revised HCS (including training) would be required to be implemented by 
June 1, 2016. Under this alternative, training costs would not be 
realized for four and a half years (as opposed to the two year 
requirement for training in the final version of this rule) while 
benefits would not be realized for five years (unchanged from the final 
rule). The results of these evaluations are presented in Table VI-2 
below and are discussed in further detail, including significant 
qualifications, in Section VI:G Net Benefits, Cost Effectiveness, and 
Regulatory Alternatives in this preamble. Although both alternatives 
show greater net benefits, the Agency concludes that the timing of the 
final rule is preferable because of additional (but unquantified) 
compliance costs and reduced (but unquantified) benefits under the 
first alternative and because of reduced (but unquantified) worker 
health and safety benefits under the second alternative. In addition, 
OSHA expects that the final rule offers coordination benefits in that 
its requirements will fully take effect at the same time as the EU 
completes its transition.

[[Page 17610]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.002


[[Page 17611]]


Economic Impacts
    To assess the nature and magnitude of the economic impacts 
associated with compliance with the final 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 final rule 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 
revisions. As described in Section VI.G: Net Benefits, Cost-
effectiveness, and Regulatory Alternatives, in this preamble, 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 VI.F: Costs of Compliance 
in this preamble, the costs of compliance with the 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 0.001 percent of revenues and about 
0.011 percent of profits, on average, across all entities; compliance 
costs represent less than 0.09 percent of revenues or, with the 
exception of three chemical manufacturing industries, less than 0.9 
percent of profits in any individual industry sector. These three 
chemical manufacturing industries are NAICS 325181 Alkalies & chlorine 
manufacturing, NAICS 325191 Gum & wood chemical manufacturing, and 
NAICS 325992 Photographic film, paper, plate, & chemical manufacturing, 
and their compliance costs as a percentage of profits are 4.3 percent, 
2.1 percent, and 2.4 percent, respectively. The higher percentage of 
profits for these three industries are mainly the result of low profit 
margins, low baseline estimates of the number of color printers 
currently employed in these industries (causing higher costs of 
compliance with the color printing requirements), and a large estimated 
number of labels produced by these industries.
    The economic impact of achieving compliance with the final rule, 
without considering the associated benefits, is most likely to consist 
of an extremely small increase in prices of about 0.001 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 
final rule 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 0.001 percent 
were not possible, profits in the affected industries would be reduced 
by an average of about 0.011 percent.
    Given the minimal potential impact on prices or profits in the 
affected industries, OSHA has concluded that compliance with the 
requirements of the 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 concludes that the effect of the 
final rule 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.
Final Regulatory Flexibility Screening Analysis
    OSHA has analyzed the potential impact of the final rule on small 
entities, and has prepared a Final Regulatory Flexibility Screening 
Analysis (FRFSA) in conjunction with this rulemaking to describe the 
potential effects on small entities. The FRFSA is included as a part of 
this preamble in Section VI:I.
    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, a Final Regulatory Flexibility Analysis (FRFA) is not 
required for this rulemaking. Nevertheless, OSHA has voluntarily 
provided the elements of the FRFA as part of the FRFSA presented in 
Section VI:I: Final Regulatory Flexibility Screening Analysis in this 
preamble. As part of this rulemaking, OSHA has fulfilled 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 FEA includes the following sections:

    B. Need for Regulation
    C. Profile of Affected Industries
    D. Benefits
    E. Technological Feasibility
    F. Costs of Compliance
    G. Net Benefits, Cost-Effectiveness, and Regulatory Alternatives
    H. Economic Feasibility and Impacts
    I. Final Regulatory Flexibility Screening Analysis
    J. Environmental Impacts
    K. Unfunded Mandates Reform Act Analysis
    L. Sensitivity Analysis

B. Market Failure and the Need for Regulation

    Employees in work environments addressed by OSHA's hazard 
communication standard (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 ensure that 
employers and employees are provided the information they need about 
the hazards in chemical products both to make informed purchases and to 
provide for safe use. The current HCS contains a set of requirements 
for chemical products, including mandatory hazard determination, 
labeling, and detailed information (in safety data sheets). Based on 
evidence presented in the record,\5\ OSHA determined that the revisions 
to the HCS will make employers' hazard communication programs more 
worker-protective, efficient, and effective. In addition, the revisions 
will have the effect of harmonizing hazard communication to facilitate 
international trade by replacing a plethora of national rules with a 
single international system.
---------------------------------------------------------------------------

    \5\ See Document ID 0303, 0313, 0322, 0324, 0327, 0328, 
0329, 0330, 0331, 0334, 0335, 0336, 0339, 0340, 0341, 0344, 0345, 
0346, 0347, 0349, 0350, 0351, 0352, 0353, 0354, 0356, 0357, 0359, 
0363, 0365, 0367, 0369, 0370, 0371, 0372, 0374, 0375, 0376, 0377, 
0378, 0379, 0381, 0382, 0383, 0385, 0386, 0387, 0388, 0389, 0390, 
0392, 0393, 0396, 0397, 0399, 0400, 0402, 0403, 0404, 0405, 0407, 
0408, 0409, 0410, 0411, 0412, 0414, 0417, 0453, 0456, 0461, and 0463 
and additional discussion in Section III of this preamble.
---------------------------------------------------------------------------

    The standard, through conformance with GHS (as explained in Section 
IV and XIII of this 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, Document ID 0293, Tr. 8). 
And much

[[Page 17612]]

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 will provide significant efficiencies and 
economies.\6\ In the case of GHS, manufacturers will be able to produce 
SDSs at lower cost, and users of SDSs will 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.\7\
---------------------------------------------------------------------------

    \6\ 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. A 
specification standard would generally not provide the efficiencies 
or economies (such as easier, less expensive training on uniform 
pictograms and a uniform SDS format made possible by this rule) to 
the regulated community that a uniformity standard would. On the 
contrary, a specification standard could impose additional costs on 
some firms that may be able to effectively protect workers using a 
cheaper alternative approach if such flexibility were permitted.
    It is also worth noting that, for uniformity standards with 
technological implications, the benefits of reduced information 
costs, economies of uniformity, and facilitation of exchange may 
need to be weighed against possible losses of flexibility, 
experimentation, and innovation. However, because GHS is limited to 
the presentation of hazard information and does not involve other 
than incidental technological or strategic considerations, the 
possible costs of uniformity here would be non-existent or 
minuscule.
    \7\ On the ability of individuals to more fully and effectively 
utilize knowledge when uniformity requirements are present, see 
Hemenway, 1975 (Document ID 0293), pp. 34-35.
---------------------------------------------------------------------------

    Since publication of the current HCS, there has been some movement 
by industry toward standardization, consistent with the revisions. 
However, OSHA does not believe that full and comprehensive 
standardization as required under the revisions, or the goal of 
harmonizing the U.S. system with the international one, can 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 current 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 can 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.\8\
---------------------------------------------------------------------------

    \8\ The coverage of fewer mixtures is due to the bridging 
principles and formula being applied to the mixtures' 
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 ensure 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 benefits achieved by a uniformity standard, 
such as GHS, cannot be obtained in the private market, without 
regulation.
    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 put pressure on 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 may not see these types of 
trade benefits unless they engage in chemical export. 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 worker illnesses, injuries, fatalities, and 
accidents due to a more consistent and comprehensible system that does 
not require English literacy to obtain some minimal hazard information;
     Greater ease of use of SDSs; and
     Less time needed to train workers due to a clearer and 
more uniform system.
    Because many of these benefits require uniformity, and the benefits 
are dispersed throughout a network of producers and users, only some of 
which have direct market relationships with each other, OSHA believes 
that only a single, uniform standard can achieve the full net benefits 
available to a hazard communications system.

C. Profile of Affected Industries

    The 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 revisions to the HCS are not anticipated to either increase or

[[Page 17613]]

decrease the scope of affected industries or establishments. The 
revisions define and revise specific classifications and categories of 
hazards, but the scope of the requirements under which a chemical, 
whether a substance or mixture of substances, becomes subject to the 
requirements of the standard is not substantially different from the 
previous version of HCS. Therefore, the revisions should have little or 
no effect on whether an entire establishment falls within the scope of 
the standard. OSHA solicited comment on this determination and received 
no comment in the record presenting contrary evidence.
    For establishments with employees exposed to hazardous chemicals, 
the revisions to the HCS will 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, these revisions to the standard will 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 determination that all production employees in 
manufacturing will be covered, and that, in addition, employees in 
other industries working in any of the occupations specified in the 
PP&E (2009) report would also be exposed to hazardous chemicals.
    Table VI-3 provides an overview of the industries and estimated 
numbers of employees potentially affected by the HCS. The data in this 
table update the estimates provided in the PEA in support of the 
proposed rule. They rely on the most recent data from the U.S. Census 
Bureau (2007a, 2007b).\9\
---------------------------------------------------------------------------

    \9\ U.S. Census Bureau (2007a). County Business Patterns, 2007. 
U.S. Department of Commerce. Available at: http://www.census.gov/econ/cbp/. U.S. Census Bureau (2007b). 2007 Economic Census. U.S. 
Department of Commerce. Available at: http://www.census.gov/econ/census07/.
---------------------------------------------------------------------------

    The industries and establishments affected by the 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 in the introduction to this FEA, OSHA has 
judged that SDSs and labels for imported chemicals would normally be 
produced in the country of origin, and thus would not represent 
expenses for importers or other US firms.
BILLING CODE 4510-26-P

[[Page 17614]]

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[[Page 17615]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.004


[[Page 17616]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.005


[[Page 17617]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.006


[[Page 17618]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.007


[[Page 17619]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.008

BILLING CODE 4510-26-c

[[Page 17620]]

    As shown in Table VI-3, approximately 75,000 firms, in over 90,000 
establishments, create hazardous chemicals (i.e., products, substances, 
or mixtures) for which a label and SDS are required in accordance with 
the OSHA HCS. In response to testimony presented on the proposed rule, 
OSHA has revised its estimate of the number of SDSs (and corresponding 
container labels) potentially affected by the revisions to the HCS from 
approximately 0.9 million SDSs to approximately 1.4 million SDSs.\10\ 
OSHA estimates that the adoption of GHS will not significantly change 
the numbers of labels and SDSs produced.
---------------------------------------------------------------------------

    \10\ A representative from the Independent Lubricant 
Manufacturers Association suggested that OSHA had underestimated the 
number of SDSs produced per firm in the lubricating oils industry 
and that the average firm in the industry produces approximately 
1,700 lubricating products requiring an SDS. OSHA has considered 
this testimony and accepted the estimate of 1,700 SDSs produced per 
firm in NAICS 324191: Petroleum lubricating oil & grease 
manufacturing. With 329 affected establishments in this industry, 
OSHA's estimate of the number of affected SDSs has increased by 
approximately 0.4 million SDSs in the FEA (as compared to the PEA). 
The industry profile has been revised accordingly (Document ID 
0495 Tr. 296-7).
---------------------------------------------------------------------------

    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 revisions 
to the OSHA HCS will 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.
    The second category of industries and establishments affected by 
the revisions contains those that do not produce labels or 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 will generally involve promoting employee awareness of 
and management familiarization with the revisions to SDSs and labels.
    As shown in Table VI-3, an estimated 41 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 labels and SDSs, a total of 44 million employees would 
potentially need to become familiar with the revisions to SDSs and 
labels. The estimated number of employees to be trained, as shown in 
Table VI-3, is equal to the number of production employees in all 
affected industries. As also shown in Table VI-3, OSHA estimates that 
there are over five million workplaces where employees may be 
potentially exposed to hazardous chemicals.
    OSHA received comment from the American Wind Energy Association and 
Duke Energy Business Services, LLC that asserted that the Agency had 
underestimated the number of employees that would need to be trained in 
the electric power generation industry (Document ID 0386 and 
0453). OSHA estimated that approximately 49 percent of employees were 
production employees in this industry who would need to be trained to 
familiarize them with the revisions to the HCS and that an additional 
11,000 managers and logistic personnel would receive training as well. 
The commenters felt that 60 to 70 percent of employees would need to be 
trained. OSHA evaluated the concerns of the AWEA and Duke Energy and 
has decided to defer to their expertise on the subject and adopt their 
recommendation (by changing the percentage of employees who would need 
to be trained in NAICS 2211 Electric power generation, transmission and 
distribution to 65 percent). The change from 49 percent of employees to 
65 percent of employees to be trained results in a negligible change to 
the costs to this industry. Increasing the number of production 
employees needing training from 245,715 to 315,623 results in an 
increase of about $39 per firm in annualized costs to this industry, 
and the costs as a percent of revenues would increase from 0.0052 
percent to 0.0060 percent.

D. Benefits

    OSHA estimates that the promulgation of the revisions to the HCS 
will 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; cost reductions for producers of 
hazardous chemicals; increased efficiencies in the handling and use of 
hazardous chemicals; reduced costs to provide HCS training to new 
employees; and other benefits as described in this section.
    OSHA expects the revisions to the HCS will result in an increased 
degree of safety and health for affected employees and a reduction in 
the numbers of accidents, fatalities, injuries, and illnesses 
associated with exposures to hazardous chemicals.
    As explained in detail in Sections IV and XIII of this 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.\11\ As a result of this research, OSHA is 
confident that the GHS revisions to the HCS for labeling and safety 
data sheets will 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 standard. 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.
---------------------------------------------------------------------------

    \11\ See Sections IV and XIII of this preamble for a discussion 
of the studies related to these issues.
---------------------------------------------------------------------------

    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 
also reduce property damage.
    It is difficult to quantify precisely how many injuries, illnesses, 
and fatalities will be prevented due to the revisions to the HCS. The 
benefits associated with the current HCS may help provide a general 
sense of the potential magnitude of the benefits of these revisions. A 
discussion and analysis of the benefits that would result from the 
implementation of the current OSHA HCS were included as part of the 
rulemaking process for the promulgation of the current standard in the 
1980s.
    The current 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, Nov. 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, Aug. 24, 1987).
    For both of these final rules, OSHA conducted research specifically

[[Page 17621]]

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 these 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, Nov. 25, 1983 and 52 FR 31872, 
Aug. 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. Applying the 
BLS inflation calculator, the $18.2 billion of benefits in 1985 is 
equivalent to $36.7 billion of benefits in 2010 after adjusting for 
inflation of 102 percent of the period.12 13
---------------------------------------------------------------------------

    \12\ http://data.bls.gov/cgi-bin/cpicalc.pl. The BLS inflation 
calculator was used on January 18, 2011.
    \13\ Using OSHA's current willingness-to-pay estimates of $8.7 
million per life saved and $62,000 per injury avoided, those 
benefits are equivalent to about $38.7 billion worth of benefits in 
2010 dollars. OSHA decided to use the lower benefits estimate in the 
text ($36.7 billion), which is consistent with the estimation 
procedure used for the proposed rule.
---------------------------------------------------------------------------

    Based on the material presented in this preamble, OSHA expects that 
the revisions to the HCS will result in incremental improvements in 
employee health and safety above that already achieved under the 
current HCS. In the PEA, OSHA estimated that compliance with the 
revisions to the HCS would result in benefits equal to 1 percent of the 
health and safety benefits attributed to the current HCS. 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 expects that actual 
benefits may be larger, perhaps several times larger.\14\ OSHA 
solicited comment on the anticipated health and safety benefits of the 
revisions to the HCS and received numerous comments indicating that 
stakeholders anticipate increased worker protection as a result of the 
revisions. The Alliance of Hazardous Materials Professionals responded 
that they believed that these revisions to the HCS would yield 
``benefits in preventing injuries and illnesses'' (Document ID 
0327) and DuPont Company reported that they ``believe domestic 
implementation of the GHS will serve to further enhance worker 
protection through a more standardized approach to hazard 
classification and communication'' (Document ID 0329). The 
National Association of Chemical Distributors said that their 
association members ``believe that there are benefits associated with 
preventing injuries, illnesses and fatalities through clearer and more 
accessible information'' (Document ID 0341) and likewise, the 
Communications Workers of America reported that they believed that 
application of the elements of the revised HCS ``would lead to a 
reduction in the incidence of workplace injuries, illnesses, and 
fatalities'' (Document ID 0349). This sentiment was echoed by 
the American Health Care Association, National Center for Assisted 
Living who felt that the revised HCS will ``reduce incidence of 
chemical-related illnesses and injuries'' (Document ID 0346), 
and the Associated General Contractors of America who felt that the 
revisions ``will allow employees to easier understand hazard 
information and will assist in better job planning and injury 
prevention'' and that they ``should reduce eye and skin contact 
injuries'' (Document ID 0404). The U.S. Chamber of Commerce 
stated that they ``(b)elieve * * * the new rule will improve workplace 
safety'' (Document ID 0397). One commenter (Document ID 
0033), representing an organization whose membership includes 
first responders and emergency management, wrote the following in 
response to the Advance Notice of Proposed Rulemaking (ANPR):
---------------------------------------------------------------------------

    \14\ OSHA believes that a reasonable range for the magnitude of 
the health and safety benefits resulting from the proposed revisions 
would be between 0.5 percent and 5 percent of the benefits 
associated with the current HCS. These ranges are considered in the 
sensitivity analysis presented in Section VI.L of this preamble.

    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.

Some stakeholders questioned whether the revisions would result in any 
health and safety benefits. For example, the Society of Plastics 
Industries, Inc. felt that there was a ``serious question as to what 
improvements to workplace safety and health can reasonably be 
expected'' (Document ID 0392), and the U.S. Chamber of 
Commerce was concerned that OSHA ``overestimated the utility and 
benefits of this proposed revision to the HCS'' (Document ID 
0397). However, even this commenter suggested the rule '' ``* 
* * will promote consistency in the identification, classification, and 
labeling of chemicals, improve workplace safety, and facilitate 
business growth and international trade.'' (Document ID 0392). 
The Agency feels that the record supports that these revisions to the 
HCS will reduce confusion and lead to better hazard communication, 
which will translate into fewer accidents, illness, injuries, and 
fatalities. OSHA's estimate that these revisions will provide one 
percent of the benefits attributed to the original HCS rulemaking 
represents a very small and easily realized improvement of workplace 
safety and health. The Agency did not receive additional comments on 
what level of benefits commenters believed would be more reasonable or 
accurate and therefore OSHA has retained the estimated health and 
safety benefits as part of the FEA. OSHA is confident that its initial 
estimates of the reductions in injuries, illnesses, and fatalities is a 
minimal estimate given the general agreement by almost all parties that 
the rule will have safety and health benefits.
    OSHA prepared a sensitivity analysis to test the effect of 
variations in its estimates and found that, even if the estimated 
health and safety benefits were overstated by a factor of 2 (or even if 
the health and safety benefits were omitted altogether--see Table VI-
1), the benefits would still exceed the costs of the final rule. Those 
results can be seen in Section VI.L: Sensitivity Analysis in this 
preamble.
    Using the 1 percent estimate, OSHA anticipates that once all 
requirements take effect for the final rule, they would result in the 
prevention of an additional 318 non-lost-workday injuries and 
illnesses, 203 lost-workday injuries and illnesses, 64 chronic 
illnesses, and 43 fatalities annually. The monetized value of these 
health and safety benefits is an estimated $367 million annually in 
2010 dollars.

[[Page 17622]]

    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 (Document ID 0274). OSHA 
believes these more recent data from 1992-2007 suggest that the 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 aligning the current HCS with the 
GHS.
    The annual health and safety benefits associated with the revisions 
to the OSHA HCS are estimated to begin after full implementation of the 
changes and associated employee training. The phase-in period for the 
main provisions of the final rule is approximately four years from the 
date of publication. Thus, in order to calculate the estimated 
annualized health and safety benefits over a twenty-year period 
associated with this 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 estimated annual benefits of $367 million, beginning 
four years after the effective date of the final rule, were multiplied 
by 0.6803 to calculate the annualized benefits over a twenty-year 
period beginning with the effective date of the final rule.\15\ Thus, 
the annualized monetized benefits associated with the reduction in 
safety and health risks attributable to the revisions to the HCS are an 
estimated $250 million.
---------------------------------------------------------------------------

    \15\ The formula for annualizing the benefits is equal to: 
[(1.07)-4] * [ (1--(1.07)-16)/0.07] * [0.07/
(1--(1.07)-20)],where the first term in brackets reflects 
the four year delay until annual benefits are realized; the second 
term in brackets reflects the present value of sixteen years of 
annual benefits (from years 5 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 record supports these savings 
with comment from Stericycle, Inc. stating that they anticipate that 
``less time will be spent in reviewing new chemicals due to the changed 
format and better characterizations of the hazard'' (Document ID 
0338), from the Ecological and Toxicological Association of 
Dyes and Organic Pigments Manufacturers (ETAD), which felt that these 
revisions to the HCS would ``ultimately increase efficiency and reduce 
time needed to prepare labels and SDSs'' (Document ID 0374), 
and from ORC Worldwide, which said that the ``use of one harmonized 
classification system is expected to significantly reduce the time 
needed to classify global products'' (Document ID 0123). The 
American Chemistry Council reported that they would ``expect a positive 
economic and time impact on developing and reviewing SDSs'' (Document 
ID 0393) as a result of these revisions to the HCS. Troy 
Corporation reported that they believed that ``providing harmonized 
SDSs will reduce development and maintenance time'' (Document ID 
0352) and that there ``will be tangible savings when materials 
only have to be classified once instead of multiple times'' (Document 
ID 0128). Two commenters suggested that harmonization could 
lead to a 50 percent time savings in classification (Document ID 
0313 and 0327). 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 revisions to the HCS for many 
businesses that purchase or use hazardous chemicals. The current non-
uniformity of SDSs and labels received by establishments in many 
industries requires employees and managers to spend additional time on 
a daily basis to ascertain the appropriate way to handle and store the 
hazardous chemicals in their workplaces. 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. There is ample evidence in the record that stakeholders 
anticipate that the revisions to the HCS will improve the quality of 
the SDSs and labels and that the standardization of the SDS and label 
elements will increase the consistency of the hazard information and 
better communicate the hazards to users (See Document ID 0313, 
0327, 0329, 0334, 0335, 0336, 0339, 0341, 0344, 0347, 0351, 0352, 0354, 
0357, 0363, 0365, 0370, 0372, 0374, 0377, 0379, 0382, 0386, 0389, 0390, 
0399, 0404, 0405, 0408, 0409, 0410, and 0414). Stakeholders reported 
that they expected that simplification and reduction in ``the number of 
documents that we manage * * * will reduce expenses'' (Document ID 
0018), and Tom Duffy testified on behalf of the United 
Steelworkers of America at the Pittsburgh, PA, public hearing that a 
uniform system for SDSs would result in time savings (Document ID 
0499 Tr. 171-72). These sentiments were echoed by Gary 
Valasek, who represented the Intercontinental Chemical Corporation 
(Document ID 0499 Tr. 63-64), the National Association of 
Chemical Distributors, which stated that standardized SDSs and labels 
would ``create a more efficient process for chemical distributors'' 
(Document ID 0341), and Wacker Chemical Company, which 
reported ``that uniformity in SDS and labels will help employees and 
customers * * * find needed information'' (Document ID 0335). 
The International Brotherhood of Teamsters reported that the 
``standardized, specific approach to labels and SDSs with a set format, 
content, and order will help with consistency and comprehensibility, 
and improve the SDSs ability to communicate hazard info to workers'' 
(Document ID 0357). The American Industrial Hygiene 
Association felt that ``standardized label elements will make hazard 
identification easier'' (Document ID 0365). The American 
Petroleum Institute commented that the revisions to the HCS would 
``improve downstream hazard assessments'' (Document ID 0376). 
OSHA solicited comment on its estimated monetized benefits in the PEA 
arising from increased efficiency in handling hazardous materials. 
While a few stakeholders questioned OSHA's benefits estimates, they did 
not offer an alternative methodology for estimating potential time 
savings; nor did they offer quantitative alternatives for OSHA

[[Page 17623]]

to evaluate. As demonstrated throughout this preamble, stakeholders 
were largely supportive of OSHA's estimates.
    For the benefits estimated in the PEA, PP&E worked closely with 
stakeholders, conducting multiple interviews and 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. Based on interviews with hazardous materials professionals 
in more than a dozen affected establishments, PP&E evaluated how these 
processes would be affected by the proposed revisions to the HCS and 
analyzed the potential savings that could reasonably be expected as a 
result of adopting these revisions.
    For the PEA, OSHA used the PP&E 2009 report (Document ID 
0273) to develop estimates of the cost reductions that the 
affected companies would expect to obtain as a result of the revisions 
to the OSHA HCS.\16\ Among the various benefits expected to be realized 
as a result of the implementation of the revisions, as described in 
this section, OSHA quantified two general categories of cost savings in 
the PEA and has maintained the methodology employed to create those 
estimates \17\ but used the most recent available economic data in 
arriving at the estimates of costs presented in this final analysis.
---------------------------------------------------------------------------

    \16\ The full final report from PP&E detailing the extensive 
process by which these estimates were derived is available on the 
rulemaking docket. See Document ID 0550.
    \17\ There is no indication that two years would have been 
sufficient time to affect the processes involved with handling 
hazardous chemicals, and therefore OSHA did not feel it necessary to 
re-estimate the savings parameters established through PP&E's 
research.
---------------------------------------------------------------------------

    In the PEA (74 FR 50280, 50322, Sept. 30, 2009), 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.\18\ 
The Agency updated the number of health and safety supervisors and 
logistics personnel for this FEA to reflect the most recent data and 
estimated that the time reductions for handling hazardous chemicals, 
and the associated cost savings, would apply to about 7,000 health and 
safety supervisors and 49,000 logistics personnel in the manufacturing 
sector and would yield annualized benefits of approximately $475 
million.\19\ Similar potential time and cost savings as a result of the 
revisions to the OSHA HCS were not quantified for the non-manufacturing 
sectors.
---------------------------------------------------------------------------

    \18\ For example, as described by PP&E (2009, Document ID 
0273), 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 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.
    \19\ These estimates assume 2,000 hours of work a year for 7,070 
health and safety supervisors and 49,486 logistics personnel 
specializing in handling hazardous chemicals in the manufacturing 
sector; an hourly wage of $66.01 and $45.17, respectively; and a 
time savings of 3 percent and 15 percent, respectively, for health 
and safety supervisors and logistics personnel. The resulting annual 
savings of $699 million was multiplied by 0.6803 to annualize the 
savings over a twenty-year period with savings not accruing until 
four years after the effective date of the revisions (Document ID 
0273).
---------------------------------------------------------------------------

    As part of the PEA (Id. at 50322-23), OSHA also estimated that, for 
the manufacturing sectors, the costs associated with the creation and 
revision of SDSs in future years would be reduced as a result of the 
revisions to the HCS. The methodology for creating this estimate has 
been retained for the FEA but new economic data were incorporated where 
available. The creation and revision of individual SDSs will be less 
burdensome, and, in addition, fewer different versions of SDSs would 
need to be produced for affected chemicals and products. OSHA estimated 
that, depending on firm size, the combination of these two effects 
would result in annual savings equivalent to between 2.5 and 4 hours of 
a professional's time per existing SDS and a total annualized savings 
of $32 million.\20\
---------------------------------------------------------------------------

    \20\ These estimates assume \1/3\ of the estimated 1,414,636 
SDSs are reviewed each year; savings per SDS is between 2 [frac12] 
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 $66; 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 $47 million was 
multiplied by 0.6803 to annualize the savings over a twenty-year 
period with savings not accruing until four years after the 
effective date of the revisions.
---------------------------------------------------------------------------

    Combining the improved productivity of personnel who use SDSs and 
the improved efficiency of those who revise SDSs and labels, OSHA 
concluded that the annualized productivity savings for companies would 
be an estimated $507 million.
    Another area in which the final rule is likely to provide cost 
savings to industry is in the provision of hazard communication 
training to new employees after the transition period. Both the current 
HCS and the revised HCS require employers to provide training on the 
safe handling of chemicals, on understanding SDSs and labels, and on 
being familiar with other information crucial to worker safety. 
Employers are permitted to offer training for categories of hazards 
(such as flammability or carcinogenicity) rather than training 
individually on each chemical. The primary sources of information for 
this training are the SDSs supplied by manufacturers, and the primary 
method for employees to determine the hazard associated with a specific 
chemical they are using is through the manufacturer's HCS-compliant 
label.
    Under the revised HCS, SDSs and labels produced in the United 
States will all be formatted in the same way. As more countries and 
regions adopt the GHS, fewer variations of SDSs and labels will be seen 
in the workplace. Information will be located in the same place on 
every SDS and label an employee will encounter. Employers will no 
longer have to train on as many SDS formats; nor will they need to 
devote as many resources to gather information on work practices, PPE, 
etc. SDSs and labels will be required to provide complete hazard 
information, and the language that the hazard information is presented 
in will be uniform across labels and section 2 of the SDSs. The 
inclusion of the pictograms and standardized hazard statement removes 
or, at least reduces, training time spent on interpreting various--and 
in some cases ambiguous--hazard warnings that current SDSs and labels 
may bear. The standardized labels and elements based on the detailed 
criteria for each hazard also greatly simplify training by facilitating 
training on ``categories of hazard'' rather than having to cover every 
chemical individually where the hazard determination is based on broad 
definitions. All of these changes can be expected to reduce the costs 
of training employees to recognize chemical hazards in the workplace.
    The rulemaking record included numerous descriptions of the 
difficulties for both employees and

[[Page 17624]]

employers associated with training under the current HCS (see Document 
ID 0307, 0499 Tr. 92-3, 0499 Tr. 167-8, 0499 Tr. 175, 0527) 
and supported the idea that training would be easier--and therefore 
cheaper--under the revised HCS (see Document ID 0123, 0338, 
0408, 0414, 0494 Tr. 74-5, 0495 Tr. 308-9, 0497 Tr. 95-6, 0499 Tr. 93, 
0499 Tr. 96, 0499 Tr. 190-91). Nevertheless, given that the annualized 
benefits of the final rule already significantly exceed the costs, OSHA 
did not feel it was necessary to try to develop, from the limited data 
available, a quantified estimate of the monetized savings resulting 
from simplified training.\21\
---------------------------------------------------------------------------

    \21\ However, in the sensitivity analysis presented in Section 
VI.L of this preamble, OSHA develops an estimate of monetized cost 
savings from simplified hazard communication training based on one 
commenter's estimate of the percentage reduction in training time 
resulting from the final rule.
---------------------------------------------------------------------------

    An additional 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. The Society for 
Chemical Manufacturers and Affiliates, for example, stated in their 
comment that while ``SOCMA member companies do not foresee significant 
savings from the change * * * for companies that do business globally 
there will be'' (Document ID 0402). While OSHA did not take 
quantitative benefits for these savings, the Agency believes that firms 
that operate globally may realize a cost savings as a result of the 
adoption of the GHS (Document ID 0336, 0339, 0361, and 0405). 
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.
    Finally, the GHS modifications to the OSHA HCS would meet the 
international goals for adoption and implementation of the GHS that 
have been 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.
    A number of commenters suggested that the benefits OSHA estimated 
will result from this rule were incorrect or overstated. The National 
Association of Homebuilders expressed a belief that OSHA's ``assumption 
that the proposed revisions to the HCS [would] result in cost 
reductions * * * due to productivity gains is false'' (Document ID 
0372), while the American Composites Manufacturers Association 
voiced concern that the benefits OSHA had estimated were speculative 
(Document ID 0407). Southern Company submitted that ``the 
benefits of adopting the GHS are minimal at best'' (Document ID 
0378). Applied Safety and Ergonomics, Inc., urged OSHA to 
adopt a more conservative view of the expected benefits as they 
asserted that ``it is possible that many of the implied or expected 
benefits of the proposed changes to the HCS may not materialize'' 
(Document ID 0396). OSHA takes these comments seriously and 
evaluated all concerns raised by stakeholders on the estimated benefits 
of this standard. Unfortunately, most commenters did not include 
adequate detail or data that would allow the Agency to evaluate 
alternative benefits estimates. While future benefits (or costs) cannot 
be estimated with scientific precision, OSHA believes that the 
estimated benefits associated with this standard are based on sound 
data and that the resulting estimates are reasonable and have largely 
been supported by testimony and comment from stakeholders. It should be 
noted that many commenters who raised questions or concerns over OSHA's 
benefits estimates still largely supported the overall aim of the 
rulemaking and wished to see OSHA proceed with promulgation. The Agency 
addresses the inherent uncertainty in the economic analysis in Section 
VI.L Sensitivity Analysis in this preamble. In that section, various 
parameters are adjusted to evaluate the impact on the overall cost and 
benefits of the rule, and OSHA finds that even if estimated benefits 
were grossly overstated, this standard's benefits would still exceed 
costs.

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. OSHA has reviewed the requirements that 
would be imposed by the rule, and has assessed their technological 
feasibility. As a result of this review, OSHA has determined that 
compliance with the requirements of the rule is technologically 
feasible for all affected industries.
    The revisions to OSHA's HCS would require employers that produce 
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. A comment in 
the record indicated that ``[s]ome of the work [* * *] has already been 
done in order to comply with GHS implementation in Asian countries'' 
(Document ID 0405; see also Document ID 0352, 0377, 
and 0410). In addition to stakeholder comments, a January 4, 2011 press 
release from the European Chemicals Agency (ECHA) announced that the 
ECHA had received 3,114,835 notifications of 24,529 substances for the 
Classification and Labelling Inventory. Industry was required to notify 
the classification and labeling of all chemical substances that are 
hazardous or subject to registration under the Registration, Evaluation 
and Authorization of Chemicals (REACH) regulation and placed on the EU 
market in accordance with the GHS criteria. NIOSH is also currently 
working to update its International Chemical Safety Cards and Pocket 
Guide to incorporate the GHS classifications, which will further reduce 
the technological burdens of reclassification borne by manufacturers. 
(For a more detailed discussion of the EU implementation of the GHS and 
NIOSH's classification work, see Section XIII. Summary and Explanation 
of the Final Rule in this preamble.) This evidence lends support to 
OSHA's assertion that the requirements of the revisions to the HCS will 
not prove technologically infeasible. The rule 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.
    The revisions to the HCS will require establishments that package 
or label hazardous chemicals to affix labels that include hazard 
warning pictograms enclosed in a red bordered diamond. While some 
establishments may not currently be printing labels in colors other 
than black and white, color printing technology is widely available

[[Page 17625]]

and printing labels with a red bordered diamond or purchasing 
preprinted labels with a red bordered diamond is not expected to 
involve any technological obstacles. Research conducted by ERG (2010) 
under contract for OSHA found that printer technology is rapidly 
evolving--resulting in lower costs for printers and printing supplies 
and making better technology available to a wider range of buyers. 
Combined with currently available printing technology, this clearly 
demonstrates that printing product labels in color is technologically 
feasible.
    Compliance with all of the requirements of the rule 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, adding some training to ensure employees are familiar with 
these changes, and upgrading printing technology with widely available 
color printers or purchasing preprinted color labels. No new 
technologies are required for compliance with the modifications to the 
HCS. OSHA is aware that many U.S. businesses in the affected industries 
have already begun implementing many of the requirements of the GHS in 
order to meet the new foreign requirements for exported products. 
Therefore, OSHA believes that there are no technological constraints 
associated with compliance with any of the requirements of the 
revisions to the HCS.

F. Costs of Compliance

Introduction
    This section presents the estimated costs of compliance for the 
revisions to the OSHA HCS. The estimated costs of compliance represent 
the additional costs necessary for employers to achieve full compliance 
with the new requirements of the final rule. They do not include costs 
associated with firms whose current practices are already in compliance 
with the new requirements.
    The costs of compliance with the revisions to the HCS consist of 
four main categories: (1) The cost of reclassification and revision of 
SDSs and labels, (2) the cost of management familiarization and other 
management costs associated with the administration of hazard 
communication programs, (3) the cost of training employees, and (4) the 
cost of printing labels for hazardous chemicals in color. The first 
three categories are considered to be one-time transitional costs and 
were included in the PEA in support of the proposed rule. The fourth 
category is new and was developed in response to comments on the 
proposed rule. It includes both one-time transitional costs and costs 
that recur throughout the life of the rule.
    The estimated compliance costs are based on a determination made by 
the Agency that the revisions would not significantly change the number 
of chemicals or products for which an SDS will be required. This also 
means that there will be no change in the number of establishments that 
are required to implement a hazard communication program. OSHA received 
no comments as part of the rulemaking record for this standard 
challenging this 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 
determined that such effects, if any, will not be significant, and 
received no comment from stakeholders disputing this determination.
    In addition to the revisions to the HCS, the rulemaking also 
includes related 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 revised HCS. OSHA has determined that the revisions 
to the other standards would not impose significant costs beyond those 
reflected in the compliance cost estimates for this rulemaking.
    In order to have compliance costs presented on a consistent and 
comparable basis across various regulatory activities, the costs of 
compliance for this rule are expressed in annualized terms. Annualized 
costs represent the more appropriate measure for assessing the longer-
term potential impacts of the rulemaking and 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.
    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 annualized cost.\22\
---------------------------------------------------------------------------

    \22\ OSHA annualized costs for this rule over a 20-year period 
in accordance with Executive Order 13563, which directs agencies 
``to use the best available techniques to quantify anticipated 
present and future benefits and costs as accurately as possible.'' 
In addition, OMB Circular A-4 states that analysis should include 
all future costs and benefits using a ``rule of reason'' to consider 
for how long it can reasonably predict the future and limit its 
analysis to this time period. Annualization should not be confused 
with depreciation or amortization for tax purposes. Annualization 
spreads costs out evenly over the time period (similar to the 
payments on a mortgage) to facilitate comparison of costs and 
benefits across different years. In this analysis, OSHA estimated a 
lifetime for hardware purchases (5 years for printers, for instance) 
which is unrelated to the annualization period. OSHA felt that an 
annualization period much shorter than 20 years (say, 10 years) 
would have been inappropriate for this rule because of the lagged 
phase-in of provisions (some of which will not take effect until 
five years after the final rule is published).
---------------------------------------------------------------------------

    Table VI-4 shows the estimated annualized compliance cost by cost 
category and by industry sector. All costs are reported in 2010 
dollars. As shown in Table VI-4, the total annualized cost of 
compliance with the rulemaking is estimated to be about $201 million. 
Of this amount, the annualized cost of chemical hazard reclassification 
and revision of SDSs and labels is an estimated $22.5 million, the 
annualized cost of training employees is an estimated $95.4 million, 
the annualized cost of management familiarization and other management 
costs is an estimated $59.0 million, and the additional annualized 
label printing costs, incurred to comply with the requirement of a 
black pictogram surrounded by a red-bordered diamond, is an estimated 
$24.1 million.
    As shown at the bottom of Table VI-4, most of the compliance cost 
associated with chemical hazard reclassification and revision of SDSs 
and labels would be borne by the chemical manufacturing industry (shown 
as the total for industries that produce SDSs and labels). Table VI-4 
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.
    Other than the costs of printing labels in color, OSHA expects that 
all compliance costs would be incurred over a period of four years, as 
the rule would incorporate a four-year transition

[[Page 17626]]

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 and 
management familiarization would be incurred in the two-year period 
following the effective date of the final standard, and that other one-
time compliance costs would be incurred in the four-year period 
following the effective date of the final standard. Initial printer 
costs to facilitate color printing would also be incurred during the 
four-year period following the effective date of the final standard, 
but all other color-printing costs would occur subsequent to the four-
year transition period on a recurring annual basis.
BILLING CODE 4510-26-P

[[Page 17627]]

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[[Page 17628]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.010


[[Page 17629]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.011


[[Page 17630]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.012


[[Page 17631]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.013


[[Page 17632]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.014

BILLING CODE 4510-26-C

[[Page 17633]]

    In the appendix to this cost section, Table VI-8 shows, by industry 
and by cost element, total non-annualized (non-discounted) compliance 
costs of about $2.1 billion estimated to be incurred during the four-
year phase-in of the revisions to the HCS.
    OSHA received numerous comments on additional costs that had not 
been considered as part of the PEA. OSHA has carefully evaluated those 
comments on costs and prepared the following responses.
    Stakeholders were concerned about the costs associated with 
relabeling current inventory. Procter & Gamble reported that they felt 
``the largest economic impact of GHS compliance to our business will be 
in the area of re-labeling'' (Document ID 0381) and numerous 
other commenters echoed those concerns (Document ID 0386, 
0392, 0393, 0400, and 0402). OSHA anticipates that the four-year phase-
in for the revisions to the OSHA HCS (increased from three years in the 
proposed rule) will provide adequate time for companies to deplete 
inventory and replace in-house containers that are labeled in 
accordance with the original OSHA HCS and therefore will mitigate any 
costs associated with relabeling in-house containers or products in 
inventory.
    The Society of Chemical Manufacturers and Affiliates was concerned 
that OSHA had not considered the costs associated with mailing revised 
labels, stating that ``a large portion of label revisions will go via 
the mail service. If a chemical manufacturer produces 75 chemicals and 
has 50 customers at 70 cents a mailing, it could cost the company as 
much as $2625.00'' (Document ID 0402). The revisions to the 
HCS do not require that establishments mail revised labels to 
customers. Manufacturers are only required to provide products labeled 
in accordance with the GHS criteria by the effective date. OSHA did 
consider the costs associated with mailing updated SDSs and determined 
that manufacturers are currently providing updated paper or electronic 
SDSs to customers as they are revised and would not incur additional 
costs associated with this standard.
    Some comments felt that OSHA had overlooked the time and costs 
associated with relabeling in-house containers with GHS compliant 
labels (Document ID 0378 and 0386). The phase-in period for 
the revisions to the HCS provides adequate time for firms to deplete 
products in inventory that are not labeled with GHS-compliant labels 
and to replace workplace containers or signs/permanent labels (such as 
regulated area signs) in the course of the normal cycle for wear-and-
tear replacement. OSHA believes that any costs incurred that are 
outside the costs that would normally be incurred to replace in-house 
containers would be negligible and has not estimated a cost for this 
activity.
    Some stakeholders anticipated costs associated with translating 
labels and SDSs into Spanish (Document ID 0381 and 0393). 
While some companies may find it necessary, based on customer demand, 
to provide products with labels and SDSs printed in Spanish, the 
revisions to the OSHA HCS do not contain any requirement for 
translating labels or SDSs into Spanish. OSHA has not taken costs 
related to translating labels and SDSs as part of this FEA.
    OSHA received comment that firms will incur costs associated with 
managing multiple SDSs during the transition period. For example, the 
Society of Plastics Industry, Inc., reported that ``multiple suppliers 
of the same chemical [may] switch over to the GHS on different 
schedules'' and that ``additional time will be required for personnel 
to sort out and implement appropriate measures for managing this 
situation'' (Document ID 0392, 0402, 0415, and 0452). OSHA 
appreciates that there may be some time during the transition period 
where some SDSs are GHS-compliant while others are not. However, given 
the non-uniformity of SDSs currently circulating to firms, the Agency 
feels that users will already have a system in place for managing 
multiple SDSs for identical products and that no additional costs will 
be incurred as a result of the transition to new SDSs.
    The U.S. Chamber of Commerce expressed concern that ``employers 
will also incur legal costs for counsel to review and analyze the 
revised SDSs to make sure the SDSs provide appropriate explanations and 
protection from liability'' (Document ID 0397). However, the 
final rule primarily changes the format of SDSs, and generally does not 
make substantial changes to the categories of information that must be 
included in the SDS. OSHA does not see why a new legal review to 
protect against tort liability would be necessary in such 
circumstances. In addition, the Agency believes that such legal costs 
would be relatively rare and not representative of the vast majority of 
employers. Furthermore, such legal costs as occur may simply be an 
alternative to other in-house professional review services that OSHA 
has already included in the costs. Finally, employers incurring such 
legal costs for SDS review arguably have been regularly incurring these 
costs under the existing HCS as part of periodic SDS changes; in that 
case, they are costs not attributable to this final rule.
    The Society of Chemical Manufacturers and Affiliates felt that 
costs would be incurred because ``someone will have to inventory all of 
the MSDSs, make the required changes and then communicate those changes 
to customers and other affected personnel'' (Document ID 
0402). The revisions to the OSHA HCS do not require 
manufacturers to provide new SDSs to customers who have purchased a 
product and received an SDS in the past. This final rule also includes 
a four-year phase-in period for firms to update their SDSs and requires 
only that those updated, GHS-compliant SDSs be provided to users who 
purchase a company's product after the effective date. OSHA realizes 
that some firms may choose to provide updated SDSs to past purchasers 
of their products, but the updates to the OSHA HCS do not require that 
they do so. Subsequently, OSHA has not taken any costs related to this 
activity.
    Ferro Corporation's comment in the rulemaking record expressed 
concern that OSHA did not take into account conversion costs for 
``MSDSs and labels for experimental products that are being resampled'' 
(Document ID 0363). OSHA's analysis does not make a 
distinction between commercial and experimental products, but it does 
not exclude costs associated with experimental products. The Agency 
feels that this economic analysis captures those costs as well as the 
transitional costs for products that are sold commercially.
    The Society of Plastics Industry, Inc. expressed concern that the 
revisions to the OSHA HCS would require employers ``to perform new 
personal protective equipment (PPE) hazard assessments, select new PPE 
or select PPE for workers who did not previously use it'' or ``to add 
or modify ventilation systems or to have their employees use 
respiratory protection to address newly discovered hazards, and to 
implement respiratory protection programs'' (Document ID 
0392). The scope of hazards covered by the GHS is very similar 
to what is covered by the current HCS as discussed in Section XIII 
Summary and Explanation. While the revisions to the OSHA HCS could, 
theoretically, result in some chemicals that were not considered 
hazardous being classified as such now, OSHA does not expect any 
significant change in chemicals covered under this final rule and did 
not receive any specific examples from stakeholders, despite

[[Page 17634]]

repeated requests for them. For this reason, OSHA has concluded that 
there will be no additional costs related to PPE for this standard.
    Multiple stakeholders questioned whether OSHA had taken into 
account the cost to update workplace signs to come into compliance with 
the revised OSHA HCS. Southern Company reported that the cost to 
purchase signs for their 29 affected plants would be $58,000 plus the 
cost of employee time to install the signs (Document ID 0378), 
and API reported that one of its member companies recently updated the 
signs at its small refinery at a cost of $200,000 (Document ID 
0376). OSHA feels that the four-year phase-in time for these 
revisions to the HCS, combined with the limited number of affected 
workplace signs, will minimize any cost that firms may incur. The 
phase-in period will allow firms to update their signs during the 
normal replacement lifecycle of three to five years for those signs and 
will result in minimal costs.
    Commenters felt that ``costs for re-classification and modification 
of SDS and labels would need to include substantial consulting fees'' 
(Document ID 0392). OSHA maintains that any firm preparing 
labels and SDSs under the current OSHA HCS will not find it 
significantly burdensome to prepare labels and SDSs under the revised 
HCS. On the contrary, OSHA expects that the revisions to the HCS would 
be able to prepare SDSs and labels at lower cost in the future (for 
which the Agency earlier, in Section VI.D: Benefits, estimated 
productivity savings). In addition, much reclassification work has 
already been done by firms that sell to the EU or to Asian markets.
Estimation of Compliance Costs
    The remainder of this section explains how the compliance costs 
arising from the final rule 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 revised final version of the PP&E 2009 report 
(Document ID 0273), the ERG (2010, 2011) reports focusing on 
the costs of printing labels in color, and the updated cost estimates 
for the final rule in ERG (2012).
    The major elements of the revisions to the HCS that involve 
compliance costs include (1) the classification of chemicals in 
accordance with the GHS criteria, and the revisions to the safety data 
sheets and labels corresponding to the affected hazardous chemicals; 
(2) even though it is not directly a result of any specific requirement 
included in the revisions to the HCS, 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; (3) 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 revisions to 
the HCS; and (4) costs to upgrade label printing technology or purchase 
labels preprinted in multiple colors in order to comply with the 
requirement that the pictogram on the label be enclosed in a red-
bordered diamond.
    The estimated compliance costs presented in this analysis of the 
revisions to the HCS are largely based on research conducted by PP&E 
(2009), which was expanded and updated for the FEA by ERG (2010, 2011, 
and 2012). Both PP&E and ERG 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, revisions to the OSHA HCS in order to 
implement the GHS.
    The estimated costs of compliance with many of the provisions of 
the final rule involve wages paid for the labor hours required to 
fulfill the requirements. In some cases, compliance could be achieved 
by purchasing services or products in lieu of paying employees 
directly. The estimated compliance costs are intended to capture the 
resources required for compliance, regardless of how individual 
establishments may choose to achieve compliance.
Costs Associated With Chemical Classifications and Revisions to Safety 
Data Sheets and Labels
    The revisions to the OSHA HCS 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 within three months after a 
manufacturer or employer becomes aware of any significant new 
information about a chemical hazard.
    The final rule requires 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 does 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 final rule may require 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 final rule. In addition, the format 
for SDSs required by the final rule is consistent with the format 
adopted by the American National Standards Institute (ANSI) and 
therefore has already been implemented by many of the affected 
businesses.
    Based on ERG (2012), OSHA developed estimates of the costs that 
would be associated with the

[[Page 17635]]

classification of chemicals in accordance with the final rule and with 
the revisions to the corresponding SDSs and labels for those chemicals. 
The estimated compliance costs represent the incremental costs that 
would be incurred to achieve compliance with the final rule. 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 revisions to the HCS would allow for a transition period of 
four years following the publication of a final rule. During this 
period, even in the absence of any pertinent OSHA rulemaking, producers 
of affected chemicals would presumably be ensuring that the information 
provided in their SDSs and labels remains accurate and current. 
Producers of hazardous chemicals are generally expected to regularly 
review the available information regarding any hazards that may be 
associated with their products and to revise SDSs and labels 
accordingly.
    In addition, for every affected product that is newly created, 
reformulated, mixed with new ingredients, modified with new or 
different types of additives, or has any changes made in the 
proportions of the ingredients used, the chemical producer would be 
required under existing OSHA and other applicable standards to review 
the available hazard information, to classify the chemical in 
accordance with applicable hazard criteria, and to develop 
corresponding SDSs and labels.
    The estimated costs of compliance with the final rule 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 reclassification 
of hazards and changes to SDSs and labels are directly related to the 
numbers of SDSs affected. Based on ERG (2012), 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 VI-3). Downstream users, distributors, and wholesalers are 
generally 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.
    The costs of compliance associated with the classification of 
chemicals in accordance with the criteria specified in the final rule 
and with the revisions to the corresponding SDSs and labels for those 
chemicals were based on PP&E industry interviews and, as described 
below, are based on the same time and software estimates as those 
presented in the proposed rule.
    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 ERG's (2012) updates to the PP&E 2009 report (Document ID 
0273), OSHA estimated the cost of hourly compensation for a 
professional for this purpose to be $66. 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 $9,240 (7 hours times 20 SDSs times $66).
    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. Again, OSHA estimated the hourly 
compensation for a professional for this purpose to be $66.
    The rulemaking record presented a wide range of estimates for the 
time required to update SDSs with a low estimate of four hours per SDS 
(Document ID 0119 and 0123), a few estimates in the range of 
25-30 hours per SDS (Document ID 0134 and 0402), and upper 
bound estimates as high as 150 hours per SDS (Document ID 
0341). OSHA evaluated these estimates and felt that the upper 
estimates are not defensible for the following reasons: (1) Firms will 
not be required to gather or evaluate additional data; (2) firms 
currently must update their SDSs periodically, and there was no 
evidence presented in the record that suggested that updates under the 
current HCS take anywhere near 150 hours per SDS; and (3) the Agency 
does not feel that it is clear that these estimates account for only 
the incremental time needed to prepare an updated SDS, taking into 
account any time that would be spent updating SDSs during the 
transition period in the absence of any revisions to the OSHA HCS. The 
Agency acknowledges that some SDS updates may take longer than the 
average listed above, but also feels that many chemicals--especially 
pure substances which will likely already have been classified 
according to the GHS for the EU or Asian markets--will take less than 
the estimated time used in the economic analysis. Therefore, OSHA feels 
that the estimated time to update SDSs used in this analysis represents 
a reasonable average for most chemicals.
    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.
    In addition to labor costs, 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 alignment with the GHS. Therefore, their 
products and services are or will be adapted to enable compliance with 
the revisions to the HCS. In addition, some firms may purchase custom 
or proprietary software from private vendors to achieve compliance with 
existing requirements or future revisions to hazard communication 
requirements or for other purposes.
    Regardless of the particular approach individual companies may 
choose to most efficiently fulfill their obligations under the existing 
HCS, OSHA expects that a part of the costs associated with achieving 
compliance with the final rule 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 $208, on average. Numerous stakeholders raised the issue of 
software updates and modifications in their comments submitted to the 
rulemaking record (Document ID 0018, 0105, 0114, 0363, 0371, 
and 0389). In response to the ANPR, the American Chemistry Council 
reported that their members estimated anticipated software update and 
conversion costs of up to $70,000. The ACC also reported that their

[[Page 17636]]

members typically have hundreds, if not thousands, of SDSs (Document ID 
0105). Using OSHA's per-SDS cost of $208, a firm that produced 
336 SDSs (which would fall within the typical range for ACC members) 
could expect to incur costs of $70,000. This example suggests that 
OSHA's estimated cost-per-SDS is a reasonable one.
    Based on ERG's (2012) updates to the PP&E 2009 report (Document ID 
0273), OSHA estimated the numbers of SDSs produced in each 
industry that would potentially need to be revised under the final 
rule. As shown in Table VI-3, a total of about 1.4 million 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 
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 OSHA final rule 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 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 OSHA final rule 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 final rule, 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. Stakeholder comment in the 
docket suggested that some of the work related to reclassification has 
already been done (e.g., Document ID 0352, 0377, 0405, and 
0410), lending support to OSHA's baseline estimates of current 
compliance rates.
    Research conducted by PP&E indicates that all of these factors 
contribute to a substantial degree of current compliance with the 
requirements of the final rule, even if the existing OSHA HCS standard 
remains unchanged.\23\ Based on the ERG (2012) updates to the PP&E 
(2009) report (Document ID 0273), OSHA estimates that, on 
average, about 53 percent of the gross costs that would otherwise be 
associated with the 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 final rule--with 
the exception of employee training--is 75 percent for firms with over 
500 employees; 25 percent for firms with 100 to 500 employees; 5 
percent for firms with 20 to 99 employees; and 1 percent for firms with 
fewer than 20 employees. OSHA used these percentages to reduce the 
number of affected firms reported in Table VI-3, for purposes of 
estimating the costs for affected firms to comply with the final rule 
(again, with the exception of employee training).
---------------------------------------------------------------------------

    \23\ By current compliance, OSHA means firms that have already 
reclassified chemicals and prepared SDSs and labels in accordance 
with GHS requirements specified in the final rule and would 
therefore be ready to introduce these modifications at negligible 
additional cost when GHS becomes effective.
---------------------------------------------------------------------------

    Based on the preceding analysis, OSHA estimates an annualized cost 
of approximately $22.5 million for the classification of chemicals in 
accordance with the criteria specified in the final rule and for 
revisions to the corresponding SDSs and labels for those chemicals.\24\
---------------------------------------------------------------------------

    \24\ This annualized estimate of $22.5 million reflects software 
costs of $55 million and labor costs of $226 million, both 
multiplied by 0.079932 to annualize these costs (incurred over the 
first four years) over a 20-year period. The $55 million in software 
costs is the result of about 264,000 modified SDSs [(929,000 SDSs 
for large establishments x 25% not in existing compliance x 95% 
requiring modification) + (233,000 SDSs for establishments with 100-
500 employees x 75% not in existing compliance x 25% requiring 
modification)] at a cost of $208 per SDS. The $226 million in labor 
cost is the result of about 666,000 affected SDSs multiplied by an 
average of 5.14 hours of professional time per SDS (from 3 to 7 
hours per SDS) multiplied by $66 per hour. The annualization factor, 
0.079932, is equal to:
    [(\1/4\] * [ (1-(1.07)-4)/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 four 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.
---------------------------------------------------------------------------

    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 ANPR published 
by OSHA in the Federal Register on September 12, 2006 (71 FR 53617) and 
the Proposed Rulemaking published by OSHA in the Federal Register on 
September 30, 2009 (74 FR 50280). 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 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.
    Comment from the Fragrance Materials Association of the United 
States (Document ID 0061) and the Flavor and Extract 
Manufacturers Association of the United States (Document ID 
0062) stated that these Associations' 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
    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

[[Page 17637]]

compared to about 100 hours currently to revise an MSDS (Document ID 
0060 and 0341).
    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.
    Ameren, an electric and gas services provider, estimated that all 
9,000 of their employees would need one hour of training initially at a 
total cost of $450,000. The company estimated that it would take 100 
hours to update their SDSs (fewer than 25) at a total cost of $6,500 
and that updating the 25,000 SDSs in their database would take five 
minutes per SDS for a total cost of $102,700 (Document ID 
0330).
    The Independent Lubricant Manufacturers Association surveyed their 
members and reported that, with one SDS per product, their members 
could be expected to incur costs of $340,000 to $559,000 ($329 or $200 
per SDS multiplied by 1700 SDSs per firm) to update SDSs. One member 
company estimated costs associated with update software at $200,000 in 
the first year and $1,000 per SDS in subsequent years to maintain the 
software and SDSs. Another company estimated that software would cost 
$50,000 and would include an additional $300,000 in staff time 
(Document ID 0371).
    Another trade organization, The Society of Chemical Manufacturers 
and Affiliates, felt that it would take ten hours to revise a label or 
an SDS (Document ID 0402).
    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 
0015, 0018, 0024, 0036, 0079, 0105, 0107, 0116, 0128, 0141, 
0145, 0327, 0341, and 0377, among others.) Many estimates are broadly 
consistent with OSHA's estimates; in addition, some estimates appear to 
be similar to, but may actually be substantially lower than, OSHA's 
estimates to the extent they include costs attributable to the existing 
standard rather than just the incremental costs associated with the 
revisions to the HCS. 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 revisions to the 
HCS, as discussed above.
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 revisions.
    Although it would not be explicitly required by the final rule, 
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 
making 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 the revised HCS; 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 management costs could be considered discretionary since they 
are not explicitly required by the 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. These costs 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 revisions to the HCS. 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. A commenter asserted that 
OSHA had overlooked the cost to train the employees who would be 
providing training to production workers (Document ID 0392), 
and the American Chemistry Council also questioned whether OSHA had 
considered the necessary training for fire, EMS, or other emergency 
workers (Document ID 0393). The Agency has included these 
occupations in the cost estimates, allocating eight hours for training 
on the revised HCS elements, and included employees responsible for 
providing training as part of the management training and 
familiarization costs and has continued to include them in estimated 
the costs of the rule for this FEA.
    In the PEA, OSHA estimated 8 hours of time, or an equivalent cost, 
would be associated with the necessary familiarization and 
implementation of

[[Page 17638]]

revisions to hazard communication programs in affected establishments 
in the manufacturing sector. Comments received on the topic of 
management familiarization yielded a wide range of time needed for this 
task. Some estimates were what OSHA considers to be unreasonably high 
(ranging from 16 to 56 hours (Document ID 0372)) and may not 
represent incremental costs only. OSHA did receive a comment that 
``eight hours * * * [may be enough to gain] a basic understanding'' of 
the revisions to the OSHA HCS but went on to say that ``as much as a 
week * * * [may be needed to gain an] understanding of the details'' 
(Document ID 0392). OSHA believes that under the current HCS, 
managers spend some time each year reviewing and updating their hazard 
communication program. So, while a manager may spend more than 8 hours 
total reviewing and familiarizing themselves with the revised HCS, a 
portion of that time would not fall under new costs resulting from the 
promulgation of the rule. OSHA did not feel that commenters presented a 
strong case for changing the estimate of incremental time needed for 
familiarization with the revised HCS and has therefore maintained the 
estimate of 8 hours.
    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 revisions to 
the OSHA standard were estimated to be two 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 $59 million for management familiarization and other 
related management activities in response to GHS.\25\
---------------------------------------------------------------------------

    \25\ This annualized estimate of $59 million reflects total 
costs of $692 million multiplied by 0.085332 to annualize these 
costs (incurred over the first two years) over a 20-year period. The 
$692 million is equal to $6 million for health and safety managers 
(7,070 affected managers x $1039 per manager (the estimated cost of 
one day training per manager) x 83% not currently in compliance) 
plus $15 million for logistics personnel in manufacturing (49,100 
affected logistics persons x 8 hours x $66 per hour x 83% not 
currently in compliance) plus $163 million for health and safety 
supervisors in manufacturing (370,000 affected health and safety 
supervisors in manufacturing x 8 hours x $66 per hour x 83% not 
currently in compliance) plus $508 million for health and safety 
supervisors in non-manufacturing (3,848,000 affected H&S supervisors 
in non-manufacturing x 2 hours x $66 per hour x 100% not currently 
in compliance).
    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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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 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 final rule. In these establishments, the incremental employee 
training costs associated with the revisions to the HCS 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 general, 
employers will need to devote real time and resources to provide the 
necessary training in order to ensure that workers are familiar with 
the new hazard communication system.
    In response to comments in the rulemaking record, the training time 
associated with the revisions to the OSHA HCS has been increased from 
those presented in the PEA. OSHA increased the estimated training time 
from 30 minutes to 60 minutes for most employees; from 15 minutes to 30 
minutes for employees with minimal contact with hazardous chemicals; 
and from 5 to 10 minutes for employees in certain occupations in the 
transportation sector, where GHS pictograms are already in use. A 
complete occupation-by-occupation summary of OSHA's estimates is 
provided in the ERG (2012) revisions to the PP&E (2009) report.
    The United Parcel Service, Inc. submitted comment supporting this 
increase, reporting that ``[i]nitial training takes about 15 minutes 
currently but will [* * *] double during the phase-in process'' and 
that ``training time (\1/2\ hr) will double to one hour [* * *] for 
employees who are `users' '' (Document ID 0369). Other 
stakeholders also felt that training time was underestimated (Document 
ID 0330, 0345, 0347, 0363, 0392, 0397, 0400, 0402, 0404, and 
0440), with the estimates of additional time needed over and above 
OSHA's estimates ranging from 15 minutes (Document ID 0330, 
0369, and 0378) to 15 hours (Document ID 0400). OSHA's 
increase of training time by 100 percent over the estimated training 
time in the PEA represents a significant increase in response to 
comments, and the Agency believes that these estimates of training 
times are reasonable. The extra time OSHA has incorporated also 
addresses concerns of some stakeholders that firms will have to offer 
two iterations of training --one before the two-year familiarization 
deadline set forth in the regulatory text, and one closer to the 
effective date when all products have been converted to GHS-compliant 
SDSs and labels (Document ID 0339). However, for costing 
purposes, all training costs for workers to become familiar with GHS 
requirements were assumed to be incurred within the first two years 
after the effective date of the final rule. OSHA received comment that 
additional training time would be required to train employees 
responsible for reclassifying chemicals under the revised HCS (Document 
ID 0392). OSHA believes that the changes to the HCS are such 
that an employer who was capable of classifying chemical hazards under 
the current HCS would be able to become familiar with the GHS criteria 
in a relatively short period of time. The Agency has also allocated 3 
to 7 hours per product to complete the reclassification and produce an 
updated SDS, which should allow for additional familiarization time if 
necessary. OSHA has not included additional training time for training 
on new hazards disclosed as a part of the transition. This concern was 
raised by a commenter (Document ID 0339), because it is 
theoretically possible that some chemicals could be classified with new 
hazards through the GHS classification schemes that were not previously 
presented in the workplace. However, the data used for classification 
is the same used for the current hazard determination, and OSHA 
believes that few new hazards would actually be introduced through this 
process. Compliance with the final rule is not expected to impose any 
additional training costs after the transition period.

[[Page 17639]]

    Based on the preceding analysis, OSHA estimates that the annualized 
cost of training employees in response to GHS would be approximately 
$95.4 million.\26\
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    \26\ This annualized estimate of $95.4 million reflects total 
costs of $1,118 million multiplied by 0.085332 to annualize these 
costs (for costing purposes, assumed to be entirely incurred over 
the first two years) over a 20-year period. The $1,118 million is 
equal to $785 million in employee hours to receive training (43.8 
million affected employees x 0.84 hours x $21 per hour) plus $333 
million in management hours to provide the training (6.0 million 
training sessions x 0.84 hours x $66 per hour). The 0.84 hours is 
the average estimated training time for all affected employees, with 
most receiving 60 minutes of training, some receiving 30 minutes of 
training, and a very few receiving 10 minutes of training. The total 
number of managers providing training (3.8 million) would, on 
average, be equal to approximately 8.7 percent of the number of 
employees receiving training in response to GHS.
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    The revisions to the HCS 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 
as part of this FEA but, based on stakeholder comment and testimony in 
the rulemaking record, OSHA anticipates that companies will realize 
cost savings in future time periods from simplified hazard 
communication training facilitated by the final rule. A qualitative 
discussion of these cost savings was presented in Section VI.D: 
Benefits in this preamble and an estimate of the possible magnitude of 
these cost savings is presented in the sensitivity analysis in Section 
VI.L in this preamble.
Cost of Color Printing
    The revisions to OSHA's HCS include a requirement that labels 
include a pictogram enclosed in a red-bordered diamond. The rulemaking 
record showed widespread (although not unanimous) support for requiring 
the red-bordered diamond. One commenter felt that ``the use of color to 
draw attention to a potential hazard is a useful tool and is likely to 
enhance the communication of safety information'' (Document ID 
0327), another stated that ``the color red has been 
universally accepted as indicating a potential danger or hazard'' 
(Document ID 0339), and others showed general support for 
requiring red borders in order to achieve the highest level of 
harmonization (Document ID 0351 and 0383). Many stakeholders 
raised concerns that this requirement would result in additional costs 
to firms since many do not currently print labels in multiple colors or 
purchase pre-printed labels in multiple colors (Document ID 
0120, 0327, 0328, 0344, 0363, 0383, 0389, and 0402). Requiring 
the red-bordered diamond on the label would mean that some firms would 
have to upgrade their printer technology or purchase more expensive 
pre-printed label stock that included the red-bordered diamond.
    OSHA estimated the cost impacts of the rule's requirement that 
pictogram borders be printed in red based on a report on the subject 
prepared by ERG (2011). That report is based on data provided in an 
earlier report prepared by ERG (2010). The full ERG reports are 
available in the rulemaking docket on regulations.gov. To estimate 
costs for this provision, OSHA estimated the number of hazard labels 
printed per year, the number of establishments that would incur costs 
to upgrade their printing technology, and the cost to those 
establishments to upgrade their printing technology. OSHA estimates 
that approximately 949 million hazard labels are printed each year and 
the total incremental cost for establishments to comply with this 
provision of the OSHA standard is $24.1 million per year. The following 
section explains how OSHA, using ERG (2010 and 2011), developed 
estimates of the number of hazard labels printed per establishment, the 
number of establishments that would need to upgrade printer technology, 
and the cost to those establishments to comply with this provision of 
the final rule.
    ERG (2011) used data on Shipment Characteristics by Commodity by 
Shipment Weight from the U.S. Census Bureau \27\ and DOT's jointly 
produced Commodity Flow Survey (CFS) (U.S. Census Bureau, 2007).\28\ 
Commodity shipments reported in this survey were classified using the 
Standard Classification of Transported Goods (SCTG) commodity 
codes,\29\ which ERG mapped to the relevant NAICS industries.
---------------------------------------------------------------------------

    \27\ U.S. Census Bureau, 2007. Commodity Flow Survey: Shipment 
Characteristics by Commodity by Shipment Weight. Available at http://www.bts.gov/publications/commodity_flow_survey/.
    \28\ U.S. Census Bureau, 2007a. American Fact Finder: Commodity 
Flow Survey. Available at http://www.census.gov/econ/census07/index.html.
    \29\ The following 13 commodity codes were considered as those 
that would potentially contain hazardous chemicals: Alcoholic 
Beverages (Commodity code 8), Gasoline, including Aviation 
(Commodity code 17), Fuel Oils (Commodity code 18), Other Coal and 
Petroleum Products (Commodity code 19), Basic Chemicals (Commodity 
code 20), Pharmaceutical Products (Commodity code 21), Fertilizers 
(Commodity code 22), Other Chemical Products & Preparations 
(Commodity code 23), Plastics and rubber (Commodity code 24), Pulp, 
newsprint, paper, and paperboard (Commodity code 27), Nonmetallic 
mineral products (Commodity code 31), Base Metal in Primary or Semi-
Finished Forms and in Finished Basic Shapes (Commodity code 32), and 
Miscellaneous Manufactured Products (Commodity code 40).
---------------------------------------------------------------------------

    For each of the SCTG commodity codes, the U.S. Census data present 
shipments of basic chemicals by shipment weight. In order to establish 
the types of shipments that might fall into each weight class, OSHA 
relied on preliminary research conducted by ERG (2010) on the weight 
and capacity of various shipping container units and the weight per 
gallon of various chemicals. Information was gathered on the types of 
containers typically used by specific industries and whether those 
containers would typically ship inside a labeled exterior container. 
OSHA calculated shipment weights for various chemicals shipped in 
various container types by multiplying the product weight per gallon by 
container capacity and adding the weight of the shipping container. As 
shown in Table VI-5, minimum, maximum, and simple average weights per 
full container were estimated for the different commodities evaluated 
in this test case using the Census-reported commodity shipments by 
shipment weight to establish some bounds on possible shipment types.

[[Page 17640]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.015

    Based on these calculations, OSHA was able to estimate the number 
of each type of container that would fall into each of the U.S. Census 
weight classes. The number of containers that would require a label 
under the OSHA HCS was refined by estimating the percentage of each 
commodity that was comprised of nonhazardous products and the 
percentage of the remaining products that would be sold to consumers. 
Neither of these types of products fall under the scope of OSHA's HCS 
and would not require a hazard warning label under the revised rule. 
For the remaining hazardous non-consumer shipments, assuming one label 
per container and one label on the outer packaging where applicable, 
ERG estimated that approximately 949 million hazard labels are applied 
annually to containers of all sizes.
    In most cases one SCTG maps to multiple NAICS industries. In order 
to divide the number of labels for each SCTG among its constituent 
NAICS industries, OSHA used receipts data from the U.S. Census Bureau's 
Statistics of U.S. Businesses to calculate receipts for a particular 
NAICS industry as a percentage of receipts for all NAICS industries 
that map to one SCTG. This percentage was used to allocate the 
estimated number of labels printed for each SCTG among its constituent 
NAICS industries.
    The labels printed per NAICS industry were then distributed among 
the various size classes based on each size class's share of receipts. 
In cases where receipts data were not available from the Statistics of 
U.S. Business (a situation found exclusively within the chemical 
manufacturing industry in the affected industries for this rule), OSHA 
calculated the average total receipts and average receipts for each 
establishment size class for six-digit NAICS in the 325 (Chemical 
Manufacturing) subsector and the ratio of average receipts for size 
class to total receipts for six-digit NAICS in 325. This ratio was 
multiplied by total receipts for the appropriate size class for each 
industry where receipts data were not available.
    Having estimated the number of hazard labels used per year for each 
NAICS code, OSHA next estimated the costs associated with printing 
those labels with red pictogram borders. Affected establishments were 
assigned to one of four categories:
    [ssquf] Category 1: Companies printing only in black who don't own 
a color printer
    [ssquf] Category 2: Companies printing in black but who own a color 
printer
    [ssquf] Category 3: Companies using pre-printed stock or labels
    [ssquf] Category 4: Companies printing color labels
    Establishments in Category 1 and Category 2 will have to buy new 
color printers (although Category 2 establishments will have to buy 
fewer new printers), as well as either color cartridges for laser 
printers or red ribbons for thermal transfer printers. Establishments 
in Category 3 will face higher costs for pre-printed stock or labels 
with red pictogram borders. Establishments in Category 4 will not face 
higher costs. Relying on conversations with companies and label 
printers/vendors, ERG allotted establishments into these four 
categories on the basis of establishment size (as shown in Table VI-6).

[[Page 17641]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.016

    Using the estimates of the percentage of establishments per 
category by size and the data presented in the industry profile, OSHA 
was able to estimate the number of establishments per category by size. 
OSHA used the ratio of SDSs produced by size class to the ratio of 
total SDSs produced and used that ratio to estimate the number of 
labels produced per size class per NAICS industry. The results are 
shown in Table VI-7.
[GRAPHIC] [TIFF OMITTED] TR26MR12.017


[[Page 17642]]


    The number of establishments per category per size class and the 
number of labels per establishment were then combined with the 
incremental costs to print in color as opposed to black only to arrive 
at an estimate of the cost of this provision.
    The unit costs by category were estimated as follows.
    A low-end laser printer was estimated to cost only a few hundred 
dollars while a higher-end laser printer can cost upwards of $1,000 to 
$5,000. OSHA estimates that on average, the incremental cost of buying 
a color printer instead of a black and white printer is $50 for a low-
end laser printer, $100 for a high-end laser printer, $100 for a low-
end thermal transfer printer, and $1,000 for a high-end thermal 
transfer printer. In this analysis, OSHA considers the cost of printers 
to be a one-time cost that establishments will incur during the four 
year transition period. The one-time, non-annualized cost to 
establishments to upgrade printer technology was estimated to be $11.8 
million. Printer costs were annualized using a 7 percent interest rate 
over a five-year period.
    The incremental cost of color cartridges for laser printers is a 
significant driver of costs under the rule. Black cartridges cost 
approximately $300, while printing in color requires buying four 
cartridges (cyan, magenta, yellow, and black) at an estimated cost of 
$1,200. Additionally, printers using black cartridges can print 20,000 
labels, while color cartridges can print only 6,000 labels. This 
results in a per-label cost of $0.015 for black cartridges and $0.20 
for color cartridges, for an incremental cost of $0.185.
    For companies using thermal transfer printers, the cost of ribbons 
varies depending on the label material, but is approximately $30 per 
ribbon for black ribbons and $40 per ribbon for red ribbons. Since both 
black and red ribbons will be required to print labels under the final 
rule, the incremental cost of printing in color is the cost of the red 
ribbon or $40. Both types of ribbons will print approximately 1,000 
labels, for a per-label cost of $0.034 for black ribbons and $0.04 for 
red ribbons, for an incremental cost of $0.01 per label.
    For companies using pre-printed stock/labels, the cost of all black 
labels is estimated to be $0.10 per label while the cost of labels with 
red pictograms is estimated to be $0.15 per label. This results in an 
incremental cost of $0.05 per label.
    For the purposes of this analysis, OSHA estimated that for those 
establishments in category 1 (those currently printing labels only with 
black ink who don't own a color printer) very small establishments will 
purchase one low-end laser printer, small establishments will purchase 
two high-end laser printers, medium establishments will purchase three 
low-end thermal transfer printers, and large establishments will 
purchase four high-end thermal transfer printers. For establishments in 
category 2 (those currently printing labels only in black ink but who 
own a color printer), OSHA estimated that very small establishments 
will purchase one low-end laser printer, small establishments will 
purchase one high-end laser printer, medium establishments will 
purchase two low-end thermal transfer printers, and large 
establishments will purchase three high-end thermal transfer printers. 
OSHA estimates that establishments in categories 3 and 4 (those 
purchasing preprinted black and white labels and those currently 
printing labels in color) will incur no costs to procure new printers.
    Using the estimates described above, OSHA was able to determine the 
current costs of printing and the cost of printing labels with red-
bordered pictograms.
    For establishments in Category 1 (those printing black and white 
labels), the current average cost per label is $0.02 and the average 
cost per establishment is $132, and for establishments in Category 2 
(those printing black and white labels but who own a color printer), 
the current average cost per label is $0.03 and the average cost per 
establishment is $344. Establishments in Category 1 and Category 2 will 
have to buy new color printers (although those in Category 2 will have 
to buy fewer printers). These establishments will also face higher 
costs for purchasing color cartridges and ribbons. For these 
establishments, the cost of purchasing a color printer becomes 
insignificant when annualized (at a 7 percent interest rate over five 
years) and when considered on a per-label basis. The main driver of 
overall costs is the incremental cost of purchasing color cartridges 
for those establishments using laser printers (establishments that OSHA 
estimates are small and very small). For very small and small 
establishments using a laser printer, the cost of cartridges goes from 
under $0.02 per label for a black cartridge to $0.20 per label for 
color cartridges. Cost increases are more modest for medium and large 
establishments using thermal transfer printers, with ribbon costs only 
increasing from $0.03 to $0.04 per label.
    For establishments in Category 3 (those who use pre-printed stock 
or labels) the current average cost per label is $0.10 and the average 
cost to purchase labels per establishment is $1,148. Establishments in 
Category 3 will have to pay more for pre-printed stock or pre-printed 
labels with red pictograms than for their current hazard labels. OSHA 
estimates that costs will increase from $0.10 per label to $0.15 per 
label, increasing printing costs by 50 percent for all establishments 
in this category.
    For establishments in Category 4 (those currently printing in 
color) the current average cost per label is $0.15 and the average cost 
per establishment is $1,880. Establishments in Category 4 will not have 
to pay any more to print red borders as they are already printing color 
labels.
    The annualized cost of printers was calculated by finding the 
present value of the incremental printer cost incurred four years after 
the rule is published (to account for the compliance time for the 
labeling provisions of the rule). This present value was annualized 
over five years at a 7 percent interest rate to account for the life of 
the printer. In the cases of printing supplies (i.e., cartridges, 
ribbons, or label stock), costs are calculated as though they would be 
incurred over a 20-year period, but would not begin to be incurred 
until four years after the rule is published. Detailed estimates are 
presented in Table VI-9 included in the appendix at the end of this 
section.
    For all establishments in all categories, the total costs 
associated with the requirement to print red pictogram borders are 
approximately $24.1 million per year, which includes the annualized 
cost of new printers (approximately $2.4 million) and of 16 years' 
worth of annual printing supply costs. OSHA feels this estimate is in 
line with the comments received on the subject as part of the 
rulemaking record. Betco Corporation estimated that requiring color 
printing would increase printing costs by 25 percent (Document ID 
0389), Dow Chemical estimated that black and white printing 
was 40 percent less expensive than color printing (Document ID 
0353), and The National Paint & Coatings Association, Inc. 
estimated an increase of 15 percent to 47 percent to print in color 
depending on the size of the label (Document ID 0328). The 
Agency also feels that the four-year phase-in period allows adequate 
time for establishments to exhaust their current stock of labels, which 
will help ameliorate some cost concerns expressed by stakeholders.

[[Page 17643]]

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 revisions to the HCS. Except for 
employee training and color printing, these costs would apply only to 
those businesses not already in compliance with the revisions.
    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 $208 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 $208 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:
     One hour per production employee in most industries;
     30 minutes in occupations exposed to few hazardous 
chemicals and types of hazards;
     10 minutes per employee in some occupations where GHS-type 
pictograms are already in use.
Color Printing
     Category 1 establishments (those currently printing only 
in black & white who do not own color printers): Large establishments 
$0.02 per label, medium establishments $0.01 per label, small 
establishments $0.13 per label, and very small establishments $0.14 per 
label.
     Category 2 establishments (those currently printing only 
in black & white but who own color printers): large establishments 
$0.02 per label, medium establishments $0.01 per label, small 
establishments $0.13 per label, and very small establishments $0.14 per 
label.
     Category 3 establishments (those currently purchasing pre-
printed label stock): large establishments $0.03 per label, medium 
establishments $0.03 per label, small and very small establishments 
$0.03 per label.
     Category 4 establishments (those currently producing 
labels printed in multiple colors): No additional costs related to this 
provision.
Appendix to Section F: Total Non-Annualized Costs of Compliance
    Table VI-8 shows the total non-annualized (non-discounted) 
compliance costs by industry and by cost element that are estimated to 
be incurred during the four-year phase-in of the revisions. Except for 
employee training and color printing, these estimates include no costs 
for businesses already in compliance with the revisions.
    As shown in Table VI-8, the total cost of compliance with the 
rulemaking over the course of the transition period of four years is 
estimated to be about $2.1 billion. Of this amount, the cost of 
chemical hazard reclassification and revision of SDSs and labels is an 
estimated $281 million, the cost of training employees is an estimated 
$1,118 million, the cost of management familiarization and other costs 
such as updates to hazard communication programs is an estimated $692 
million, and the one-time printer costs for companies needing to 
upgrade printing technology to print labels in color is an estimated 
$12 million.
    Table VI-9 summarizes OSHA's estimates for printing costs. It shows 
annualized per-label costs by category and establishment size ranging 
from $0.01 to $0.14 and total annualized costs by category and 
establishment size. Total annualized costs include the cost of printers 
annualized over five years and the cost of printing supplies incurred 
over a 20-year period beginning four years after the rule is published.
BILLING CODE 4510-26-P

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BILLING CODE 4510-26-C

G. Net Benefits, Cost-Effectiveness, and Regulatory Alternatives

    Table VI-1 provides a summary of the costs and benefits of the 
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 $556 million annually, expressed in 2010 dollars 
and using a 7 percent discount rate. (Using a 3 percent discount rate 
instead would have the effect of lowering the costs to $161 million per 
year and increasing the gross benefits to $839 million per year. The 
result would be to increase net benefits from $556 million to $678 
million per year.) The cost-effectiveness of the standard can be 
expressed as more than three 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 ANPR published by 
OSHA in the Federal Register on September 12, 2006 (71 FR 53617) and 
the Proposed Rule published by OSHA in the Federal Register on 
September 30, 2009 (74 FR 50280). There was widespread support among 
the commenters for the adoption of GHS in the United States (Document 
ID 0340, 0344, 0347, 0349, 0351, 0354, 0357, 0359, 0366, 0382, 
0390, 0403, 0408, and 0414). Many stakeholders anticipate that the 
revisions to the HCS will ``achieve more effective hazard 
communication'' (Document ID 0344 and 0351), ``enhance the 
consistency and quality of hazard information for workers'' (Document 
ID 0347), and ``serve to further enhance worker protection'' 
(Document ID 0329). These sentiments were echoed in many of 
the comments submitted to the record and in much of the testimony 
delivered at the public hearings. This voicing of support included 
commenters who provided some of the largest estimates of the costs of 
the revisions (Document ID 0032, 0050, 0329, 0338, and 0341).
    The available alternatives to the final rule are somewhat limited 
since this rule modifies the current HCS in order to align with the 
provisions of the UN's GHS. In Section III, the Agency qualitatively 
discussed the two major alternatives presented during this rulemaking 
process--(1) voluntary adoption of GHS within the existing HCS 
framework and (2) a limited adoption of specific GHS components and a 
variation on (1) that would require compliance with GHS but allow an 
exemption for small businesses to comply with either the current HCS or 
with the GHS-compliant HCS. All of these alternatives were soundly 
rejected by stakeholders. To allow certain parties to follow an 
alternative system or to allow voluntary adoption of the elements of a 
uniformity standard does nothing to reduce confusion, improve 
efficiency, or simplify processes. In order for those benefits to be 
realized, all elements must apply to all affected parties. OSHA has 
determined that both of the alternatives presented above would 
eliminate significant portions of the benefits of the rule.
    OSHA did not attempt to evaluate the costs and benefits for the 
regulatory alternatives that involved partial or voluntary adoption of 
the GHS. The Agency did evaluate two alternatives where the effective 
dates were altered. For both alternatives, OSHA re-estimated the costs, 
benefits, and net benefits simply by adjusting the effective dates in 
its formulas. The results are summarized in Table VI-10.
    In the first alternative considered, all elements of the revised 
HCS would be required to be implemented within two

[[Page 17651]]

years. Under this alternative, all transitional costs would be incurred 
in two years and benefits would be realized beginning in the third 
year. OSHA estimated that annualized costs under this alternative would 
increase by $5 million, from $201 million to $206 million, while 
annualized benefits would increase by $166 million, from $757 million 
to $923 million. Estimated net benefits would therefore increase by 
$161 million, from $556 million to $717 million. However, OSHA believes 
that these estimates fail to capture the difficulty many firms would 
encounter in meeting these tighter enforcement dates. As a result, 
initial compliance rates would probably be lower and less effective, 
leading to reduced benefits. In addition, some compliance costs--such 
as for labels and signs--were viewed in this final rule as incremental, 
reflective of taking place within a normal replacement cycle of 3 to 5 
years. With implementation required within two years, these costs could 
no longer be treated as incremental to existing HCS requirements, but 
would have to be recalculated as total replacement costs.
    The second alternative that OSHA evaluated extended the timeline 
for training to be completed. For this alternative, all elements of the 
revised HCS (including training) would be required to be implemented by 
June 1, 2016. Under this alternative, training costs would not be 
realized for four and a half years (as opposed to the two-year 
requirement for training in the final version of this rule) while 
benefits would not be realized for five years (unchanged from the final 
rule). OSHA estimated that annualized costs under this second 
alternative would decrease by $12 million, from $201 million to $189 
million, while annualized benefits would be unchanged. Estimated net 
benefits would therefore increase by $12 million, from $556 million to 
$568 million. However, these estimates fail to recognize that workers 
will be exposed to (some) GHS-compliant labels and SDS formats well 
before the 4\1/2\ year training date. The Agency would therefore expect 
an increase in injuries, illnesses, and fatalities as untrained workers 
are unable to effectively process and respond to the revised labels and 
SDS formats. As a result, benefits and net benefits would actually 
decline relative to those estimated for the final rule.
    In summary, although both alternatives show greater net benefits, 
the Agency concludes that the timing of the final rule is preferable 
because of additional (but unquantified) compliance costs and reduced 
(but unquantified) benefits under the first alternative and because of 
reduced (but unquantified) worker health and safety benefits under the 
second alternative. In addition, OSHA expects that the final rule 
offers coordination benefits in that its requirements will fully take 
effect at the same time as the EU completes its transition.

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H. Economic Feasibility and Impacts

    This section presents OSHA's analysis of the potential economic 
impacts of the final rule 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 
Final Regulatory Flexibility Screening Analysis, conducted in 
accordance with the criteria laid out in the Regulatory Flexibility 
Act.
    To determine whether a rule is economically feasible, OSHA begins 
with two screening tests to consider minimum threshold effects of the 
rule under two extreme cases: (1) All costs are passed through to 
customers in the form of higher prices (consistent with a price 
elasticity of demand of zero), and (2) all costs are absorbed by the 
firm in the form of reduced profits (consistent with an infinite price 
elasticity of demand).
    In the former case, the immediate impact of the rule would be 
observed in increased industry revenues. While there is no hard and 
fast rule, in the absence of evidence to the contrary, OSHA generally 
considers a standard to be economically feasible for an industry when 
the annualized costs of compliance are less than a threshold level of 
one percent of annual revenues. Common-sense considerations indicate 
that potential impacts of such a small magnitude are unlikely to 
eliminate an industry or significantly alter its competitive structure, 
particularly since most industries have at least some ability to raise 
prices to reflect increased costs and normal price variations for 
products typically exceed three percent a year (OSHA, 2011, Chapter 
VI). Of course, OSHA recognizes that even when costs are within this 
range, there could be unusual circumstances requiring further analysis.
    In the latter case, the immediate impact of the rule would be 
observed in reduced industry profits. OSHA uses the ratio of annualized 
costs to annual profits as a second check on economic feasibility. 
Again, while there is no hard and fast rule, in the absence of evidence 
to the contrary, OSHA generally considers a standard to be economically 
feasible for an industry when the annualized costs of compliance are 
less than a threshold level of ten percent of annual profits. This is a 
fairly modest threshold level, given that normal year-to-year 
variations in profit rates in an industry can exceed 40 percent or more 
(OSHA, 2011, Chapter VI).
    For this final rule, all hazardous chemicals distributed in the 
United States have to be in compliance with the SDS and labeling 
revisions to the HCS, and chemical producers and users in most advanced 
economies will be under comparable GHS requirements (encompassing 
training, etc.) specific to their own country or economic union. For 
this reason, affected domestic establishments should not be susceptible 
to foreign competitors not bound by the requirements of the revisions 
to the HCS or similar GHS requirements. As a result, OSHA expects that 
the costs of this final rule will be passed on in higher prices rather 
than absorbed in lost profits, and therefore the Agency will tend to be 
primarily concerned with the ratio of industry costs to industry 
revenues rather than with the ratio of industry costs to industry 
profits.
    In order to assess the nature and magnitude of the economic impacts 
associated with compliance with the final rule, OSHA developed 
quantitative estimates of the potential economic impact of the 
requirements on each of the affected industry sectors. The estimated 
costs of compliance presented in Section VI.F of this preamble were 
compared with industry revenues and profits to provide a measure of 
potential economic impacts. Although Section VI.G also contains 
estimates of substantial productivity benefits arising from this final 
rule that more than offset the estimated costs, these cost savings have 
not been included in estimating the economic impacts of the final rule.
    Table VI-11 presents data on revenues and profits for each affected 
industry sector at the six digit NAICS industry level, along with the 
corresponding estimated annualized costs of compliance in each sector. 
Potential impacts in the table are represented by the ratios of 
compliance costs to revenues and compliance costs to profits.
    As is evident from the data and estimates presented in Table VI-6, 
the costs of compliance for the final rule are not large in relation to 
the corresponding revenues and profits in each of the industry sectors. 
The estimated costs of compliance represent about 0.001 percent of 
revenues and about 0.011 percent of profits on average across all 
entities; compliance costs represent less than 0.09 percent of revenues 
or, with the exception of three chemical manufacturing industries, less 
than 0.9 percent of profits in any individual industry sector. These 
three chemical manufacturing industries are NAICS 325181 Alkalies & 
chlorine manufacturing, NAICS 325191 Gum & wood chemical manufacturing, 
and NAICS 325992 Photographic film, paper, plate, & chemical 
manufacturing, and their compliance costs as a percentage of profits 
are 4.3 percent, 2.1 percent, and 2.4 percent, respectively. The cost 
of printing labels in color is the main cost driver for these 
industries.
    Based on the Agency's two screening tests to determine if the 
economic impacts of the final rule exceed some minimum threshold level 
(i.e., costs equal to one percent of revenue or ten percent of 
profits), OSHA concludes that the rule 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 (DC Cir. 1980)). The potential impacts of employer 
costs associated with achieving compliance with the final rule fall 
well within the bounds of economic feasibility in each industry sector. 
OSHA does not expect compliance with the requirements of the final rule 
to threaten the viability of employers or the competitive structure of 
any of the affected industry sectors.
    The economic impact of the final rule is most likely to consist of 
a very small increase in prices for affected hazardous chemicals, of 
about 0.001 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 revision to SDS and labeling criteria 
and one-time investments in printing technology 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 final rule 
can be substantially recouped with a minimal increase in prices, there 
would be little or no effect on profits.
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    In profit-earning entities, compliance costs can generally be 
expected to be absorbed through a combination of increases in prices 
and reductions in profits. The extent to which the impacts of cost 
increases affect prices or profits depend on the price elasticity of 
demand for the products or services produced and sold by the entity.
    The price elasticity of demand refers to the relationship between 
changes in the price charged for a product and the resulting changes in 
the demand for that product. A larger price elasticity of demand 
implies that an entity or industry is less able to pass increases in 
costs through to its customers in the form of a price increase and must 
absorb more of the cost increase through a reduction in profits.
    In the case of cost increases that may be incurred due to the 
requirements of the final rule, 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 increases in prices potentially resulting from 
compliance with the final rule 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 overall economic impact of the final rule 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 final rule, 
OSHA expects that societal welfare will increase as a result of the 
revisions to the HCS, as the benefits far exceed compliance costs. The 
final rule is estimated to yield net annualized benefits of over $800 
million.
    Second, until now, many of the costs associated with the injuries, 
illnesses, and fatalities resulting from the risks addressed by the 
final rule 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 concludes that the effects of the 
final rule on employment, wages, and economic growth for the United 
States would be negligible. This final rule is expected to result in 
increased import and export opportunities with U.S. trading partners 
due to the harmonization of the U.S. system with GHS. Hence, the 
primary effect on international trade, for businesses of all size, is 
likely to be favorable. This determination was supported by comment in 
the rulemaking record. For example, the Society of Chemical 
Manufacturers and Affiliates reported that companies that do business 
globally would see benefits related to the revisions to the OSHA HCS 
(Document ID 0402). Other stakeholders anticipate benefits 
related to global harmonization (Document ID 0382, 0388, 0393, 
and 0405) and mention that the standardization of the HCS will benefit 
those who are involved in international trade (Document ID 
0410).
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 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.

I. Final Regulatory Flexibility Screening Analysis

    The Regulatory Flexibility Act (5 U.S.C. 601-612), as amended in 
1996, requires the preparation of a Final Regulatory Flexibility 
Analysis (FRFA) for rules where there would be a significant economic 
impact on a substantial number of small firms. Under the provisions of 
the law, each such analysis shall contain:
    1. A description of the impact of the rule on small entities;
    2. A statement of the need for, and objectives of, the rule;
    3. The response of the agency to any comments filed by the Chief 
Counsel for Advocacy of the Small Business Administration in response 
to the proposed rule, and a detailed statement of any change made to 
the proposed rule in the final rule as a result of the comments;
    4. A statement of the significant issues raised by the public 
comments in response to the initial regulatory flexibility analysis, a 
statement of the assessment of the agency of such issues, and a 
statement of any changes made in the proposed rule as a result of such 
comments;
    5. A description of and an estimate of the number of small entities 
to which the rule will apply or an explanation of why no such estimate 
is available;
    6. A description of the projected reporting, recordkeeping and 
other compliance requirements of the 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; and
    7. A description of the steps the agency has taken to minimize the 
significant economic impact on small entities consistent with the 
stated objectives of the applicable statutes, including a statement of 
the factual, policy, and legal reasons for selecting the alternative 
adopted in the final rule and why each one of the other significant 
alternatives to the rule considered by the agency which affect the 
impact on small entities was rejected.
    The Regulatory Flexibility Act further states that the required 
elements of the FRFA 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 (5 U.S.C. 605(a)).
    As explained below, OSHA believes that the final rule will not have 
a significant economic impact on a substantial number of small 
entities, and therefore a FRFA is not required by the Regulatory 
Flexibility Act. Nonetheless, OSHA has prepared this voluntary FRFA to 
assure the regulated community that the agency has considered the 
impacts of the final rule on small entities. 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 FEA

[[Page 17661]]

and its supporting materials, this voluntary FRFA will summarize the 
key aspects of OSHA's analysis as they affect small businesses.

1. A Description of the Impact of the Final Rule on Small Entities

    The final regulation requires 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 III: Need and Support in this 
preamble, the HCS does not currently require testing of chemicals, and 
will not require testing with adoption of the GHS.\30\)
---------------------------------------------------------------------------

    \30\ OSHA's estimation methodology assumes that firms will 
undertake the most cost effective method of complying with an OSHA 
requirement. Therefore, if firms choose to perform testing or to 
incur other costs not required by an OSHA rule they do so only 
because they feel there is some benefit to be gained.
---------------------------------------------------------------------------

    For the purpose of its cost analysis, OSHA estimated four 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);
    (3) Costs of training affected employees on how to find the 
information they need on SDSs and to comprehend pictograms and standard 
labels; and
    (4) Costs to upgrade printing technology or purchase multi-colored 
labels to comply with the requirement that the pictograms be presented 
in a red-bordered diamond.
    OSHA believes that, with the exception of the cost of color 
printing ink or printing cartridges or the cost of purchasing color 
pre-printed labels, these costs are a one-time cost that would be 
incurred during the four-year transition period after the final rule is 
published. OSHA anticipates that, once the final rule is implemented, 
the costs under the revised OSHA HCS will be only marginally higher 
than the costs under the existing HCS system and consist solely of the 
costs associated with color printing supplies. Once chemical producers, 
distributors, and users set up for and shift to the GHS system, OSHA 
expects there will be no additional costs arising from the final rule 
for classification, SDSs, and labeling.
    OSHA also anticipates that, after the four-year transition period, 
the revisions to the HCS--resulting in more consistent chemical 
classifications and more uniform SDSs and labels--will yield production 
efficiencies for health and safety managers, logistics personnel, and 
others who handle hazardous chemicals. These cost savings (in addition 
to the health benefits for affected workers arising from this final 
rule) are considered in Section VI.D: Benefits in this preamble.
    OSHA's criteria for determining whether there are significant 
economic impacts on a substantial number of small firms are that, for 
small entities in any given industry, the annualized costs exceed 1 
percent of revenues or 5 percent of profits. 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 (defined by OSHA as those with 
fewer than 20 employees), shows that in no industry size class do the 
annualized costs exceed 0.28 percent of revenues or 3.3 percent of 
profits, and in almost all cases the annualized costs for small and 
very small firms are below 0.01 percent of revenues and 0.1 percent of 
profits. For affected small firms as defined by SBA, the average 
annualized cost per firm of the final rule would be $52 per year, which 
is equal to 0.001 percent of annual revenue and 0.03 percent of annual 
profit for the average firm. In terms of chemical-producing industries 
only, the average annualized cost per small firm as defined by SBA 
would be $544 per year, which is equal to 0.004 percent of annual 
revenue and 0.03 percent of annual profit for such a firm. For affected 
firms with fewer than 20 employees, the average annualized cost per 
firm of the final rule would be $35 per year (or 0.002 percent of 
annual revenue and 0.04 percent of annual profit), and the average 
annualized cost per firm that produces chemicals would be $255 per year 
(or 0.02 percent of annual revenue and 0.2 percent of annual profit).
    Given these results, OSHA concludes that the final rule will not 
have a significant economic impact on a substantial number of small 
entities. Thus, a FRFA 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 FRFA as part of this 
Regulatory Flexibility Analysis (RFA) and has analyzed the potential 
impact of the revisions to OSHA's HCS on small entities. As described 
in Section VI.D Benefits in this preamble, the revisions to the HCS, on 
the whole, are expected to result in significant net benefits to 
employers, as the associated cost savings outweigh the corresponding 
compliance costs. This same conclusion generally applies to the small 
entities affected by the final 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 cost savings and health and safety benefits.
    The total annualized cost of compliance with the final rule for 
small entities is estimated to be approximately $119 million, as shown 
by industry in Table VI-12.
    To assess the potential economic impact of the final rule 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 VI-12. OSHA expects that among small entities potentially 
affected by the final rule, the average increase in prices necessary to 
completely offset the compliance costs would be 0.0013 percent. The 
average price increase necessary to completely offset compliance costs 
would not exceed 0.18 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 0.03 percent for affected small entities. For 
small entities in most affected industries, the compliance costs could 
be completely absorbed through an average reduction in profits of less 
than 0.3 percent; the reduction in profits would be no more than 3.3 
percent among small entities in any of the affected industries.
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    To further evaluate the potential for any adverse effects on small 
entities resulting from the final rule, OSHA assessed the short-term 
impacts that may be associated with the compliance costs during the 
transition period.
    The total non-annualized compliance costs for small entities during 
the four-year transition period are estimated to be $1,330 million, or 
about $333 million per year for four years. Thus, the potential 
temporary impact would be about 0.004 percent of revenues or about 0.07 
percent of profits, on average, per year for four years for affected 
small entities.
    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 final rule on very small entities, defined as 
those with fewer than 20 employees. As shown in Table VI-13, the total 
annualized costs for entities in this size class would be an estimated 
$67 million. The annualized costs represent about 0.002 percent of 
revenues and 0.04 percent of profits, on average, for affected very 
small entities. The annualized costs did not exceed 0.3 percent of 
revenues or 3.3 percent of profits for very small entities in any 
affected industry.
    The total non-annualized compliance costs for very small entities 
during the four-year transition period are estimated to be $789 
million, or about $197 million per year for four years. Thus, the 
potential temporary impact on very small entities would be about 0.005 
percent of revenues or 0.1 percent of profits, on average, per year for 
four 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 final rule to exceed 5 percent of profits. OSHA found that the 
firm would have to produce 7,065 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 7,065 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____2859.aspx)
    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 310 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 
7,065 chemical products and very small firms that produce more than 310 
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 without the assistance of specialized 
computer software, which OSHA assumes most small firms do not use, 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 with similar ingredients. Once appropriate data for the 
ingredients of these mixtures had been developed, using the bridging 
principles outlined in Appendix A of this 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.
    OSHA therefore concludes that there are not a substantial number of 
small entities or very small entities that would have significant 
economic impacts from this rule as a result of producing a very large 
number of distinct chemical products.
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2. A Statement of the Need for, and Objectives of, the Rule

    OSHA's HCS was first adopted in 1983 for manufacturing (48 FR 
53280, Nov. 25, 1983). Later the Agency expanded the scope of coverage 
to include all industries where employees are potentially exposed to 
hazardous chemicals (52 FR 31852, Aug. 24, 1987).
    The HCS requires chemical manufacturers and importers to evaluate 
the hazards of the chemicals they produce or import. The current rule 
provides definitions of health and physical hazards to use as the 
criteria for determining hazards in the evaluation process. Information 
about chemical hazards and appropriate 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, provides employees the knowledge of the hazards and 
identities of the chemicals, and gives employees the opportunity to 
participate actively in the successful control of exposures. Together 
employers and employees can use this information to reduce the 
potential for adverse effects to occur. The information transmitted 
under the HCS requirements provides the foundation upon which a 
workplace chemical safety and health program is built. Without this 
information, appropriate controls could not be identified and 
implemented.
    OSHA's HCS is designed to disseminate information on chemicals, 
which will precipitate changes in handling methods and thus protect 
those potentially 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 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 
Labelling of Chemicals in December 2002.
    The final rule incorporates the GHS's requirements into the HCS. 
They 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 will be 
standardized in a way that they are not under the existing HCS. 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 will benefit 
employers and enhance employee safety. Employers who use chemicals and 
employees exposed to those chemicals will benefit from receiving the 
revised labels and safety data sheets prepared in a consistent format. 
OSHA believes that the information will 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 will be to integrate the new 
approach into the workplace hazard communication program, including 
ensuring that both employers and employees understand the pictograms 
and other information provided on the chemicals' labels and SDSs.
    OSHA believes that adoption of the GHS will improve labels and SDS 
comprehensibility through implementation of a uniform 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 result in 
a lack of consistency makes it difficult for users of chemicals to 
properly identify their hazards and recommended 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, 
will help all users, including employers, employees, and emergency 
responders, to more easily identify the critical information necessary 
to protect employees.
    In addition, OSHA believes that American employees and employers 
will 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 the belief that there are 
significant benefits associated with implementation of a globally 
harmonized approach to hazard communication. Countries, international 
organizations, chemical producers, users of chemicals, and employees 
working with chemicals would all benefit. There are at least four 
reasons to expect that GHS will be adopted globally.
    First and foremost, the GHS modifications of the HCS will enhance 
protection of workers and the environment. Occupationally related 
injuries, illnesses, and fatalities remain a serious problem in the 
U.S. For example, although likely to contain very

[[Page 17676]]

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 this FEA, the adoption of the revisions 
to OSHA's HCS 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, many 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. The U.S. expects to improve and build on worker 
protections it already has.
    Second, OSHA believes that the final rule will facilitate 
international trade in chemicals. It will reduce the burdens caused by 
having to comply with differing requirements for the same product and 
facilitate small business participation 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 will reduce the 
need for this duplicative testing. It should be noted, however, that 
OSHA's HCS 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 used to achieve 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 their neighbors' pollution and other effects of uncontrolled 
chemical exposures. In all countries, there is a need to acquire 
sufficient information to properly handle chemicals when they are 
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. will 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, many 
employers deal with at least two sets of federal requirements. Thus 
these employers would be likely to obtain some benefits from domestic 
harmonization.
    OSHA has made a determination that the revisions to the HCS 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 are exposed, and in 
reducing the incidence of chemical-related occupational illnesses and 
injuries. OSHA estimates that (1) savings in benefits from improved 
employee health and safety exceed the costs of the final rule, and (2) 
cost savings to chemical users exceed the costs of the final rule.
    An additional and more complete discussion of the reasons why this 
standard is being promulgated by the Agency is provided in other 
sections of this preamble.
    The primary objective of aligning the HCS with the GHS is to 
achieve the 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 
potentially exposed to hazardous chemicals in the workplace and 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 all chemical hazards are 
properly 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 recommended 
protective measures. Labels, SDSs, and training are complementary parts 
of a comprehensive hazard communication program--each element 
reinforces the knowledge necessary for effective protection of 
employees.
    Information provided in accordance with the HCS serves to reduce 
the incidence of chemical-related illnesses and injuries in the 
workplace. This is accomplished by modifying the behavior of both 
employers and employees. For example, the information contained in the 
HCS enables employers to implement protective measures in the 
workplace. Employers will also have information to choose less 
hazardous alternatives or select appropriate engineering controls, work 
practices, and personal protective equipment. Improved understanding of 
chemical hazards by supervisory

[[Page 17677]]

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 final 
rule does not alter that approach. Rather, the final 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.
    3. The response of the agency to any comments filed by the chief 
counsel for advocacy of the small business administration in response 
to the proposed rule, and a detailed statement of any change made to 
the proposed rule in the final rule as a result of the comments.
    The Office of Advocacy in the SBA did not submit any comments to 
OSHA in response to the proposed rule.
    4. A statement of the significant issues raised by the public 
comments in response to the initial regulatory flexibility analysis, a 
statement of the assessment of the agency of such issues, and a 
statement of any changes made in the proposed rule as a result of such 
comments.
    OSHA received numerous comments in the record about the impact of 
this rulemaking on small entities. There were concerns about OSHA's 
preliminary cost estimates and concerns that this rule would have a 
substantial impact on small manufacturers. OSHA carefully evaluated 
these concerns and has addressed them below as well as in Section VI.F: 
Costs of Compliance in this preamble.
    Some stakeholders felt that OSHA should convene a Small Business 
Regulatory Enforcement Fairness Act (SBREFA) panel for this rulemaking 
(Document ID 0361, 0372, 0397, 0407, and 0411). OSHA evaluated 
this rule under the provisions of the Regulatory Flexibility Act, which 
requires that OSHA hold a SBREFA (or SBAR--Small Business Advocacy 
Review) panel when a rule is expected to have a significant impact on a 
substantial number of small entities. The modifications to the hazard 
communication standard do affect a substantial number of small 
entities, but the costs per firm do not rise to the level where they 
would impose a significant economic impact on a substantial number of 
small entities. OSHA defines a significant economic impact on small 
entities as costs that exceed one percent of revenues or five percent 
of profits for small entities in any affected industry. The Regulatory 
Flexibility Act does not define the term ``significant economic 
impact.'' Instead, as noted in the RFA's legislative history, Congress 
suggested that agencies refer to SBA guidelines for measuring the 
impact of rules on small businesses. See 126 Cong. Rec. S10,942 (Aug. 
6, 1980). In relevant guidance, the SBA's Office of Advocacy states 
that the impact of a regulation ``could be significant if the cost of 
the proposed regulation (a) eliminates more than 10 percent of the 
businesses' profits; (b) exceeds 1 percent of the gross revenues of the 
entities in a particular sector or (c) exceeds 5 percent of the labor 
costs of the entities in the sector.'' See ``A Guide for Government 
Agencies: How to Comply with the Regulatory Flexibility Act'' (http://archive.sba.gov/advo/laws/rfaguide.pdf). Notably, OSHA's threshold of 5 
percent of profits is significantly more protective of small businesses 
than the Office of Advocacy's suggested threshold of 10 percent.
    OSHA's two thresholds have long been a part of the Agency's 
published SBREFA procedures (See http://www.dol.gov/dol/regs/appendix.htm, prepared pursuant to Section 212 of the SBREFA) and were 
originally developed in close cooperation with the Office of Advocacy 
(See SBA Office of Advocacy, 2003, p. 18).
    Furthermore, in employing a dual threshold, based on either revenue 
or profit impacts, OSHA has taken special pains to identify potentially 
significant impacts on small entities.\31\
---------------------------------------------------------------------------

    \31\ By comparison, many other agencies, such as EPA and the 
Department of Homeland Security, rely only on revenue impacts. See 
also Aeronautical Repair Station Ass'n, Inc. v. F.A.A., 494 F.3d 
161, 175 (D.C. Cir. 2007). (Federal Aviation Administration made 
determination that proposed regulation would not have significant 
economic impact on substantial number of small entities based on its 
calculation of annualized costs of less than 1 percent of annual 
median revenue); Washington v. Daley, 173 F.3d 1158, 1171 (9th Cir. 
1999) (parties agreed that economic impact of Department of Commerce 
regulation would be considered significant if regulation resulted in 
more than 5 percent reduction in annual gross revenues). It should 
also be noted that, in OSHA's experience, the 5-percent 
profitability threshold is much more likely than the 1-percent 
revenue threshold to trigger a significant impact on a substantial 
number of small entities. This is supported by the fact that, with 
profit rates in the United States equal to approximately 6 percent 
of revenues (as it is, on average, for all firms affected by this 
final rule), for a firm with profits of 6 percent of revenues, 5 
percent of profits will be approximately equivalent to 0.3 percent 
of revenues.
---------------------------------------------------------------------------

    While this rule will be costly in the aggregate, it is not 
aggregate costs but the significance of impacts on small entities that 
triggers the need for a SBREFA panel. No panel was or is needed for 
this rulemaking because costs per small entity do not meet the 
threshold that OSHA uses to define a significant economic impact on a 
substantial number of small entities.
    Stakeholders also expressed concerns that costs were underestimated 
and that costs to small entities would be considerable. The U.S. 
Chamber of Commerce asserted that ``the imposition of a completely new 
system of classification of chemicals represents huge burdens on small 
employers with significant costs'' (Document ID 0397). OSHA 
acknowledges that there will be transitional costs for small businesses 
but feels that the additional transition time OSHA has incorporated 
into the final rule and discussed in more detail elsewhere in the FEA, 
combined with OSHA compliance assistance and the fact that many firms 
have already made the transition to GHS, should allow small employers 
to adopt the GHS criteria without overwhelming challenges. The U.S. 
Chamber of Commerce did not provide additional details, which were 
solicited as part of both the ANPR and the NPRM, on what types of costs 
small businesses would incur or the possible magnitude of those costs. 
Without detailed estimates, OSHA cannot fully evaluate alternative 
costs for small businesses; nor can OSHA adopt alternative cost 
estimates without persuasive evidence in the record.
    Wacker Chemical Company felt that the changes to the HCS would have 
a large impact on small businesses ``result[ing] from the lack of 
personnel and financial resources to implement changes of this 
magnitude which may involve reclassification of the companies' 
products, reauthoring SDSs

[[Page 17678]]

and labels, and training personnel'' (Document ID 0335), and 
IBM Corporation expressed concern that small businesses ``may not have 
the technical resources and skill to generate safety data sheets for [* 
* *] mixtures'' (Document ID 0334). The Agency believes that 
small firms have the expertise to make the hazard determinations and 
meet the other transitional requirements of the revised HCS and, other 
than comments on the possibility of technical expertise being an issue 
for small firms asserted by a few firms who do not qualify as small, 
OSHA did not receive solid evidence that a lack of technical expertise 
among small firms would actually be a significant issue. Chemical 
manufacturers and users have been able to comply with the current HCS, 
and manufacturers have been able to make the classification 
determinations and label their products in the appropriate manner. In 
addition, some small firms are likely already complying with the 
requirements of GHS in order to facilitate international trade. The 
revised HCS will not be considerably more technical or require 
considerably more expertise in order to comply than the current HCS. 
There is also no evidence, from the experiences of firms in the EU or 
in Asian markets where the GHS criteria for classification of 
chemicals, label elements, and SDS formats have already been adopted 
into practice, that small firms are not able to comply due to either 
overwhelming costs or to a lack of technical expertise required to make 
the changes.
    Many comments expressed general concern that OSHA underestimated 
the compliance burden on small businesses (Document ID 0336, 
0372, 0397, and 0407), and OSHA has increased some costs (for instance, 
doubling the time required for training) in response to these comments. 
The comments, while appreciated and insightful, did not contain the 
level of detail that OSHA would need in order to make a case for 
changing many of the estimates in the PEA. For the most part, comments 
received on the issue of costs to and impacts on small businesses 
simply stated that (in general) costs to small businesses were 
understated in the PEA or asserted that impacts would be significant 
without providing data to support alternative estimates. In order to 
assess the impacts on the cost effectiveness of this standard of 
possible underestimation of cost parameters, the Agency has included a 
sensitivity analysis in Section VI.L: Sensitivity Analysis in this 
preamble. Additional concerns about costs that are not specific to 
small businesses are addressed further in Section VI.F: Costs of 
Compliance in this preamble.
    Many commenters, including some who voiced concerns about costs, 
did not support a voluntary adoption approach or any other exemption or 
modified system for small businesses (Document ID 0324, 0327, 
0328, 0329, 0335, 0338, 0351, 0352, 0370, 0376, 0377, 0381, 0382, 0393, 
and 0410). DuPont felt that dual systems would ``undermine the goal of 
harmonization [* * * and] be very confusing for employees'' (Document 
ID 0329). Ferro Corporation expressed the view that ``failure 
to implement [the requirements of the rule] across-the-board will cause 
confusion; negate main benefits; and potentially be less protective'' 
(Document ID 0363).
    Many of the commenters who addressed small business issues felt 
that the benefits to small businesses would be negligible (Document ID 
0372, 0378, 0385, 0396, 0397, 0400, 0402, and 0407). 
Commenters who viewed the primary benefits of adopting the GHS as 
facilitating international trade were likely to favor an alternative of 
less than full compliance with GHS. As has been addressed throughout 
the FEA, however, OSHA's estimates of the benefits of this final rule 
reflect fewer worker injuries and illnesses, efficiency improvements in 
the safe handling of hazardous chemicals, and less costly and more 
effective hazard communication training of new workers. While OSHA 
recognizes the significant potential trade benefits of this final rule, 
the Agency did not quantify or monetize these benefits.
    In response to numerous comments received in the record, OSHA has 
extended the phase-in period for this rulemaking and aligned the phase-
in of this rule to correspond to the EU's deadline for classification 
of mixtures. Some of these comments asserted that more time would be 
especially beneficial to small businesses, reducing the compliance 
burden significantly (Document ID 0399, 0405, and 0408). For 
example, the National Association of Chemical Distributors suggested a 
timeline of 3 years plus 18 months for distributors and downstream 
users (Document ID 0341). The effective dates in the final 
rule take these (and other suggestions) into account and provide 
substantial additional time for implementation. Where the proposal 
required all labels and SDSs to be in compliance with the new 
requirements in three years after publication (or August 2014), the 
final rule requires manufacturers and importers to modify labels and 
SDSs by June 1, 2015. The final rule also gives distributors an 
additional six months, until December 1, 2015, to sell stock labeled 
under the current standard. In addition, employers are given another 
six months, until June 1, 2016, to update their training and their 
hazard communication program with any new hazard information received 
because of the final rule. Finally, the proposal required that exposed 
employees receive initial training two years after adoption (or August 
2013), whereas the final rule gives employers until December 1, 2013 to 
complete this training.
    5. Description of and estimate of the number of small entities to 
which the rule will apply.
    OSHA has completed an analysis of the economic impacts associated 
with this final rule, including an analysis of the type and number of 
small entities to which the final rule applies. 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 final standard impacts 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 final rule is 
estimated to potentially affect a total of 4,093,543 small entities, as 
shown in Table VI-12. The rule has its greatest impacts on the 72,040 
small firms that produce chemicals that require SDSs and labels.
    6. Description of the projected reporting, recordkeeping, and other 
compliance requirements of the rule.
    The final 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 
final rule also modifies other OSHA standards that contain hazard 
communication requirements to harmonize them with the requirements of 
GHS. In addition, certain OSHA standards use HCS terms, and OSHA is 
making changes to ensure that the scope of those standards is not 
changed by the GHS revisions.
    The preamble to the final standard provides a comprehensive 
description of, and further detail regarding, the compliance 
requirements of the rulemaking. A description of the types

[[Page 17679]]

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 and 
color printing, these costs would apply only to those small businesses 
not already in compliance with the revisions.
    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 $208 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:
     One hour per production employee in most industries;
     Thirty minutes in occupations exposed to few hazardous 
chemicals and types of hazards;
     Ten minutes per employee in some occupations where GHS-
type pictograms are already in use.
    Color Printing
     Category 1 establishments (those currently printing only 
in black & white who do not own color printers): Medium establishments 
$0.01 per label, small establishments $0.13 per label, and very small 
establishments $0.14 per label.
     Category 2 establishments (those currently printing only 
in black & white but who own color printers): Medium establishments 
$0.01 per label, small establishments $0.13 per label, and very small 
establishments $0.14 per label.
     Category 3 establishments (those currently purchasing pre-
printed label stock): Medium establishments $0.03 per label, small and 
very small establishments $0.03 per label.
     Category 4 establishments (those currently producing 
labels printed in multiple colors): No additional costs related to this 
provision.
    7. A description of the steps the Agency has taken to minimize the 
significant economic impact on small entities.
    OSHA has extended the phase-in period for this rulemaking in 
response to stakeholder concern. The Agency believes that the 
additional time granted to manufacturers, distributors, and users of 
chemicals will serve to reduce the transitional costs associated with 
this rule. Chemical manufacturers currently revise SDSs and labels 
periodically to include new or updated hazard information, and the 
extended time frame will allow firms to adopt the GHS criteria into 
their hazard communication program and to modify SDSs, warning labels, 
and workplace signs within the normal flow of their operations.
    OSHA will be offering guidance materials such as quick cards and 
fact sheets to aid firms in developing and implementing the training 
requirements of this rule. OSHA will also be releasing a small business 
compliance guide to provide additional guidance to small businesses, 
which will ease the economic impact and compliance burden. The Agency 
solicited comment from stakeholders as part of the ANPR and NPRM on 
what compliance assistance tools would be most helpful and has 
incorporated the suggestions received in the record in the development 
of guidance materials.

J. Environmental Impacts

    OSHA has reviewed the provisions of this final rule 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 Department of 
Labor's NEPA Procedures (29 CFR Part 11). As a result of this review, 
OSHA has determined that the final rule will 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 
rule will, in addition to increasing employee health and safety, have 
positive effects on the environment.

K. 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 the final HCS rule, the rule does not involve any 
unfunded mandates being imposed on any State or local government 
entity.
    Based on the analysis presented in this economic analysis, OSHA 
concludes that the final rule would impose a Federal mandate on the 
private sector in excess of $100 million in expenditures in any one 
year. Accordingly, this economic analysis of the final rule, concerning 
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)).

L. Sensitivity Analysis

    In this section, OSHA provides a sensitivity analysis of the major 
assumptions underlying the Agency's estimates of the annualized costs 
and annualized benefits of the final rule. The purpose is to determine 
whether OSHA's conclusion that the final rule yields net benefits is 
vulnerable to a reasonable change in any one of these assumptions. 
OSHA's choice of how much to increase unit cost parameters in the 
sensitivity analysis was intended to reflect an upper bounds (or more) 
of reasonableness, based on comments, as well as on professional 
experience and common sense. (As a result, there are almost no 
estimates provided by commenters of higher unit costs than we used in 
the sensitivity analysis, and we rejected those few outliers as being 
unrealistically large and certainly not representative of the average 
establishment covered by this rule.) OSHA's choice of how much to 
decrease unit benefit parameters was more subjective and reflected the 
fact that few commenters provided alternative quantitative estimates. 
Broadly, the Agency cut unit benefit parameters by at least half in all 
cases for the sensitivity analysis, which OSHA believes is consistent 
with the spirit of comments that either supported OSHA's estimates of 
benefits or thought benefits were somewhat overestimated--the exception 
being those few commenters who disputed the existence of health and 
safety benefits or productivity benefits arising from the proposed 
rule. However, it should be carefully noted that any given benefit 
category could be reduced to zero and the net benefits would still be 
positive. This can be seen in Table VI-1, which shows that the 
estimated net positive annualized benefits of the final rule ($556 
million)

[[Page 17680]]

significantly exceed the estimated annualized benefits for any 
individual category of benefits--Reduction in Safety and Health Risks 
($250 million); Productivity Improvements for Health and Safety 
Managers and Logistics Personnel ($475 million); and Savings during 
Periodic Updating of SDSs and Labels ($32 million).
    The sensitivity analysis below shows that OSHA's conclusion that 
the final rule produces net benefits is not dependent on any particular 
assumption. In fact, the estimated annualized health and safety 
benefits of the rule alone, independent of any productivity benefits, 
exceed the estimated annualized cost of the rule. Further, the broad 
support from industry for this rule, even from those commenters 
critical of some of OSHA's estimates of costs and benefits, suggests 
that industry believes the productivity benefits of the rule exceed the 
costs.
    The methodology and calculations underlying the estimation of the 
compliance costs, benefits, and economic impacts associated with this 
rulemaking are generally linear and additive in nature. Thus, the 
sensitivity of the results and conclusions of the analysis will 
generally be proportional to variations in the relevant input 
parameters.
    For example, if the estimated time that companies need to 
reclassify chemical hazards and revise SDSs and labels were doubled, 
the corresponding labor costs (but not software costs) of 
reclassification and revision of SDSs and labels would double as well.
    OSHA evaluated a series of such changes in input parameters to test 
whether and to what extent the general conclusions of the economic 
analysis held up. On the whole, OSHA found that the conclusions of the 
analysis are reasonably robust, as changes in any of the input 
parameters tend not to produce disproportionately large changes in the 
results. The results also show significant net annualized benefits for 
the rule regardless of the individual revisions to costs, benefits, or 
discount rate. The results of the individual sensitivity tests are 
summarized in Table VI-14 and are described in more detail below.
BILLING CODE 4510-26-P

[[Page 17681]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.044

BILLING CODE 4510-26-C

[[Page 17682]]

    In the sensitivity test on costs 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 VI-14, the estimated total costs of compliance would 
increase by $18 million annually, or by about 9 percent, while net 
benefits would also decline by $18 million, from $556 million to $538 
million annually.
    In a second sensitivity test, OSHA doubled the estimated total 
number of affected SDSs addressed by this rulemaking, which increased 
the estimated total cost of reclassification and revision of SDSs and 
labels. As shown in Table VI-14, if OSHA's estimates of other input 
parameters remained unchanged, the total estimated costs of compliance 
would increase by $23 million annually, or by about 11 percent, while 
net benefits would also decline by $23 million annually, from $556 
million to $533 million annually.\32\
---------------------------------------------------------------------------

    \32\ 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 VI-8, this effect would increase 
benefits by $32 million annually, more than offsetting the $23 
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 VI-14, if OSHA's estimates 
of other input parameters remained unchanged, the total estimated costs 
of compliance would increase by $48 million annually, or by about 24 
percent, while net benefits would also decline by $48 million annually, 
from $556 million to $508 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 VI-14, if OSHA's estimates of 
other input parameters remained unchanged, the total estimated costs of 
compliance would increase by $96 million annually, or by about 48 
percent, while net benefits would also decline by $96 million annually, 
from $556 million to $460 million annually.
    OSHA performed a fifth sensitivity test where the estimated 
incremental per-label cost of printing labels in color was doubled. As 
shown in Table VI-14, if OSHA's estimates of other input parameters 
remained unchanged, the total estimated costs of compliance would 
increase by $24 million annually, or by about 12 percent, while net 
benefits would also decline by $24 million annually, from $556 million 
to $532 million annually
    OSHA also performed sensitivity tests on several input parameters 
used to estimate the benefits of the final rule. In one sensitivity 
test on benefits, OSHA reduced its estimate of health and safety 
benefits of the final rule from 1 percent to 0.5 percent of the 
benefits estimated for the existing HCS. As shown in Table VI-14, if 
OSHA's estimates of other input parameters remained unchanged, the 
total estimated benefits of the final rule would decline by $125 
million annually, or by about 17 percent, while net benefits would also 
decline by $125 million annually, from $556 million to $431 million 
annually.
    In a second, parallel sensitivity test on benefits, OSHA increased 
its estimate of health and safety benefits of the final rule from 1 
percent to 5 percent of the benefits estimated for the existing HCS. As 
shown in Table VI-14, if OSHA's estimates of other input parameters 
remained unchanged, the total estimated benefits of the final rule 
would increase by $1,000 million annually, or by about 132 percent, 
while net benefits would also increase by $1,000 million annually, from 
$556 million to $1,556 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 VI-14, if OSHA's estimates 
of other input parameters remained unchanged, the total estimated 
benefits of the final rule would decline by $17 million annually, or by 
about 2 percent, while net benefits would also decrease by $17 million 
annually, from $556 million to $539 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 VI-14, if 
OSHA's estimates of other input parameters remained unchanged, the 
total estimated benefits of the final rule would decline by $315 
million annually, or by about 42 percent, while net benefits would also 
decrease by $315 million annually, from $556 million to $241 million 
annually.
    And finally, in the fifth sensitivity test on benefits, OSHA tested 
the effect of including cost savings from simplified hazard 
communication training in future periods made possible by the final 
rule.\33\ For this sensitivity test, OSHA added a cost savings of a 
half hour, on average, in training time per new employee once the 
transition period ends and the final rule is fully implemented. OSHA 
chose a half-hour time savings based on the testimony of the one 
commenter who provided an estimate of the time savings from simplified 
hazard communication training.\34\ As shown in Table VI-14, as a result 
of adding the half-hour savings in training time, assuming OSHA's 
estimates of other parameters remain unchanged, the total benefits of 
the final rule would increase by $285 million annually,\35\ or by about 
38 percent, while net benefits would also increase by $285 million 
annually, from $556 million to $841 million annually.
---------------------------------------------------------------------------

    \33\ As noted in the earlier discussion on benefit, in Section 
VI.D of this preamble, comments on the proposed rule contained 
extensive qualitative support for the proposition that the revisions 
to the HCS rule will make training easier and therefore less time-
consuming and less costly.
    \34\ Printing Industries of America testified at the OSHA public 
hearing held in Pittsburgh that training for an employee who would 
be responsible for working with hazardous materials is 
``approximately an hour to an hour and a half'' and that training 
would be less time-consuming under the revised HCS and might be 
reduced ``possibly by a third simply because [the revised HCS will] 
be removing a number of types [of MSDS and labeling systems]'' 
(Document ID 0499, Tr. 96-7). This estimate would be 
consistent with a saving in training time of one-third to one-half 
of an hour relative to current training time of one to one and a 
half hours. OSHA chose the one-half-hour estimate because a 
representative training time for all the commenters would be at 
least an hour and a half (and arguably more like 3 hours). 
Furthermore, in its final economic analysis for the original hazard 
communication rule, OSHA estimated that the rule would require an 
average of 3 hours of training per employee (48 FR 53280, Nov. 25, 
1983).
    \35\ This estimate uses the BLS turnover rate to arrive at the 
number of new employees per year per establishment and assumes from 
one to ten employees per training session, depending on 
establishment size. The cost savings due to simplified training take 
into account one half hour of managerial time to deliver the 
training plus one half hour of time for each of 17.5 million new 
employees a year to receive the training. The annualized cost 
savings of $285 million is equal to annual cost savings of $465.5 
million multiplied by an annualization factor of 0.6130 to reflect 
the fact that these cost savings would not begin to be realized 
until five years after the effective date of the final rule.
---------------------------------------------------------------------------

    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 $161 million per year and increasing the gross 
benefits to $839 million per year. The result, as shown in Table VI-14, 
would be to increase net benefits by

[[Page 17683]]

$122 million per year, from $556 million to $678 million per year.
    OSHA also considered the sensitivity of its findings that the final 
rule is economically feasible and does not have a significant economic 
impact on a substantial number of small entities. For example, even if 
all of the estimated annualized costs of compliance were to increase by 
50 percent, these costs would still represent less than 0.005 percent 
of annual revenues and less than 0.1 percent of annual profit for the 
average establishment, small entity, or very small entity, and no small 
entity or very small entity would have costs in excess of 1 percent of 
revenues or 5 percent of profits.
    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 a 50 percent increase in 
all of the compliance cost estimates, 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 entities, and the conclusion 
that the benefits of the final rule exceed the costs.

VII. OMB Review Under the Paperwork Reduction Act of 1995

    The final rule revises 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. On October 30, 2009, the Department of Labor submitted 
Hazard Communication collection of information requirements identified 
in the NPRM to OMB for review in accordance with 44 U.S.C. 3507(d). In 
accordance with 44 U.S.C. 3506(c)(2), the proposed regulation solicited 
public comments on the revision of the Hazard Communication Standard's 
(HCS) Information Collection Request (ICR) (paperwork burden hour and 
cost analysis) for the proposal. OSHA received no public comments on 
the Hazard Communication Standard's ICR. On November 18, 2009, OMB 
filed a comment on the Hazard Communication Standard NPRM ICR in 
accordance with 44 U.S.C. 3507(d). OMB stated, ``This OMB action is not 
an approval to conduct or sponsor an information collection request 
under the Paperwork Reduction Act of 1995.'' The final Standard 
modifies existing information collection requirements that are 
currently approved under OMB Control Number 1218-0072. This ICR has 
been revised and submitted to OMB. OSHA will publish a separate notice 
in the Federal Register that will announce the result of OMB's reviews. 
The Department of Labor notes that a Federal agency cannot conduct or 
sponsor a collection of information unless OMB approves it under the 
PRA- 95, and the agency displays a currently valid OMB control number. 
Also, notwithstanding any other provision of law, no employer shall be 
subject to penalty for failing to comply with a collection of 
information if the collection of information does not display a 
currently valid OMB control number.
    The final rule standardizes the hazard communication requirements 
for hazardous chemical products used in U.S. workplaces, and thus 
provides 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 (SDSs). The final standard 
harmonizes the U.S. system with international norms and as a result 
would enhance worker safety and facilitate international trade. The 
final rule's modifications to the Hazard Communication 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 SDSs; and (4) related revisions to definitions of 
terms used in the Standard and to requirements for employee training on 
labels and SDSs.
    Paragraph (d), ``hazard classification,'' requires chemical 
manufacturers and importers to evaluate chemicals produced in their 
workplaces or imported by them to classify the chemicals' 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 hazard 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 also 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. When classifying 
mixtures they produce or import, chemical manufacturers and importers 
of mixtures may rely on the information provided on current SDSs of the 
individual ingredients except where the chemical manufacturer or 
importer knows, or in the exercise of reasonable diligence should know, 
that the SDS misstates or omits information required by the provisions 
in the final HCS.
    Pursuant to paragraph (e), employers are required to develop, 
implement, and maintain at each workplace a written hazard 
communication program which at least describes how the criteria 
specified in paragraphs (f), (g), and (h) of the standard on labels and 
other forms of warning, SDSs, and employee information and training 
will be met, and which also includes the following: (i) a list of the 
hazardous chemicals known to be present using a product identifier that 
is referenced on the appropriate SDS (the list may be compiled for the 
workplace as a whole or for individual work areas); and (ii) the 
methods the employer will use to inform employees of the hazards of 
non-routine tasks (for example, the cleaning of reactor vessels) and 
the hazards associated with chemicals contained in unlabeled pipes in 
their work areas. The final rule makes no changes to this requirement.
    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;

[[Page 17684]]

    (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.

    The chemical manufacturer, importer, or distributor must ensure 
that the information provided under (i) through (v) above must be in 
accordance with the 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 labels in the workplace, except as provided in paragraphs 
(f)(7) and (f)(8) of the Standard, employers must ensure that each 
container of hazardous chemicals in the workplace is labeled, tagged, 
or marked with either (i) the information specified under (f)(1)(i) 
through (v) for labels on shipped containers; or (ii) product 
identifier and words, pictures, symbols, or combination thereof, which 
provide at least general information regarding the hazards of the 
chemicals, and which, in conjunction with the other information 
immediately available to employees under the hazard communication 
program, will provide employees with the specific information regarding 
the physical and health hazards of the hazardous chemical.
    OSHA has also updated 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 heath 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 has modified the 
language to be compatible with GHS and consistent throughout the OSHA 
standards. The GHS classification process for a specific substance 
dictates the hazard warnings and the precautionary statements that will 
be required on the new GHS-compliant product 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 final rule modifies the language requirements for signs and 
labels found in the Agency's health standards listed below in Table 
VII-1. Since the final rule provides 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) the product identifier and 
words, pictures, symbols, or combination thereof, which provide at 
least general information regarding the hazards of the chemicals.
BILLING CODE 4510-26-P

[[Page 17685]]



 
                               Table VII-1
 
 
 

[GRAPHIC] [TIFF OMITTED] TR26MR12.045


[[Page 17686]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.046

BILLING CODE 4510-26-C
    Pursuant to paragraph (f)(11), chemical manufacturers, importers, 
distributors, or employers who become newly aware of any significant 
information regarding the hazards of a chemical shall revise the labels 
for the chemical within six months of becoming aware of the new 
information, and shall ensure that labels on containers of hazardous 
chemicals shipped after that time contain the new information. 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.
    Paragraph (g)(2) requires the chemical manufacturer or importer 
preparing the 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).

    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; and
    Section 16, Other information, including date of preparation or 
last revision.

    Although not required by the final rule, an employer may include 
the following sections to be consistent with the GHS:

    Section 12, Ecological information;
    Section 13, Disposal considerations;
    Section 14, Transport information; and
    Section 15, Regulatory information.

    Paragraph (g)(5) requires the chemical manufacturer, importer or 
employer preparing the SDS 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 SDS 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 SDS within three 
months. If the chemical is not currently being produced or imported, 
the chemical manufacturer or importer must add the information to the 
SDS before the chemical is introduced into the workplace again.
    Paragraph (g)(11) requires that employers ensure the SDSs 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).
    OMB Control Number: 1218-0072.
    Affected Public: Business or other for-profit.
    Number of Respondents: 5,514,697.
    Frequency: On Occasion.
    Average Time per Response: The average time per response ranges 
from twelve seconds for employers to label portable in-plant containers 
to seven hours for employers to reclassify chemicals and revise SDSs 
and labels.
    Estimated Total Burden Hours: 11.3 million hours.
    Estimated Cost: $34.7 million.

VIII. Federalism and Consultation and Coordination With Indian Tribal 
Governments

    The Agency reviewed this final rule according to the most recent 
Executive Order (``E.O.'') on Federalism (E.O. 13132, 64 FR 43255, 
August 10, 1999). This E.O. requires that Federal agencies, to the 
extent possible, refrain from limiting State policy or local

[[Page 17687]]

policymaking discretion, consult with States and local officials prior 
to taking any 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 E.O. 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.
    In Section 18 of the Occupational Safety and Health Act (the OSH 
Act), Congress expressly provides that States may adopt, with Federal 
OSHA approval, a plan for the development and enforcement of 
occupational safety and health standards. States that obtain Federal 
approval for such plans are referred to as ``State Plan States'' (29 
U.S.C. 667). Occupational safety and health standards developed by such 
State Plan States, among other things, must be at least as effective in 
providing safe and healthful employment and places of employment as 
Federal OSHA standards.
    OSHA intends to closely scrutinize amendments to previously 
approved State hazard communication standards submitted under current 
or future State plans to ensure 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 also 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).
    This final rule complies with E.O. 13132. In States that do not 
have OSHA-approved State Plans, this rule limits State policy options 
in the same manner as all OSHA standards.
    OSHA also reviewed this final rule in accordance with E.O. 13,175 
on Consultation and Coordination with Indian Tribal Governments (65 FR 
67,249 (Nov. 9, 2000)), and determined that it does not have ``tribal 
implications'' as defined in that order. The final rule does not have 
substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian tribes.

IX. State Plans

    When federal OSHA promulgates a new standard or more stringent 
amendment to an existing standard, the 27 States or U.S. territories 
with their own OSHA-approved occupational safety and health plans must 
revise their standards to reflect the new standard or amendment, or 
show OSHA why there is no need for action, e.g., because an existing 
state standard covering this area is already ``at least as effective'' 
as the new federal standard or amendment. 29 CFR 1953.5(a). The state 
standard must be at least as effective as the final federal rule, must 
be applicable to both the private and public (state and local 
government employees) sectors, and must be completed within six months 
of the publication date of the final federal rule. When OSHA 
promulgates a new standard or a standards amendment which does not 
impose additional or more stringent requirements than an existing 
standard, states are not required to revise their standards, although 
OSHA may encourage them to do so.
    The 27 States and U.S. territories with OSHA-approved occupational 
safety and health plans are: Alaska, Arizona, California, Hawaii, 
Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New 
Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, 
Utah, Vermont, Virginia, Washington, and Wyoming. Connecticut, 
Illinois, New Jersey, New York and the Virgin Islands have OSHA 
approved State Plans that apply to public-sector employees only.
    This final rule modifies OSHA's hazard communication standard to 
conform to the United Nations' Globally Harmonized System of 
Classification and Labelling of Chemicals (GHS). It requires chemical 
manufacturers to use revised criteria for classification of chemical 
hazards, revised labeling provisions, and a specified format for safety 
data sheets. There are also revised requirements for employers to train 
their employees regarding labels and safety data sheets for hazardous 
chemicals. This GHS rule will also increase worker protection by 
improving the quality and consistency of information provided to 
employers and employees regarding chemical hazards and protective 
measures. Therefore, State Plan States must adopt comparable provisions 
within six months of publication of the final rule. Each State's 
existing requirements will continue to be in effect until it adopts the 
required revisions.

X. Unfunded Mandates

    OSHA reviewed this final rule according to the Unfunded Mandates 
Reform Act of 1995 (``UMRA''; 2 U.S.C. 1501 et seq.) and Executive 
Order (``E.O.'') 12875 (58 FR 58093, Oct. 28, 1993).
    Under Section 202 of the UMRA, an agency must prepare a written 
``qualitative and quantitative assessment'' of the anticipated costs 
and benefits of any Federal regulation creating a mandate that ``may 
result in the expenditure by State, local, and tribal governments, in 
the aggregate, or by the private sector, of $100,000,000 or more'' in 
any one year. 2 U.S.C. 1532(a). As discussed in section VI of this 
preamble (``Final Economic and Voluntary Regulatory Flexibility 
Analysis''), the Agency estimates that this final rule will require 
private sector employers annualized expenditures of $201 million per 
year. However, OSHA's final rule 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, this final rule does 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, this rulemaking did 
not trigger the requirements of UMRA based on its impact on State, 
local, or tribal governments.
    Based on the analysis presented in the Final Economic Analysis 
(section VI above), OSHA has determined that this final rule will 
impose a Federal mandate on the private sector in excess of $100 
million in expenditures in any one year, and is thus subject to the 
requirements under UMRA for review of private sector costs. The Final 
Economic Analysis in section VI, satisfies these requirements, and 
provides a written statement containing the qualitative and 
quantitative assessment of costs and benefits as is required under 
Section 202(a) of UMRA (2 U.S.C. 1532).

[[Page 17688]]

XI. Protecting Children From Environmental Health and Safety Risks

    E.O.13045 requires that Federal agencies submitting covered 
regulatory actions to OMB's Office of Information and Regulatory 
Affairs (OIRA) for review pursuant to E.O.12866 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. 
E.O.13045 defines ``covered regulatory actions'' as rules that may (1) 
be economically significant under E.O.12866 (i.e., a rulemaking that 
has an annual effect on the economy of $100 million or more, or would 
adversely effect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities), and (2) concern an environmental health risk or safety 
risk that an agency has reason to believe may disproportionately affect 
children. In this context, the term ``environmental health risks and 
safety risks'' means risks to health or safety that are attributable to 
products or substances that children are likely to come in contact with 
or ingest (e.g., through air, food, water, soil, product use). This 
final rule is economically significant under E.O.12866 (See section VI 
of this preamble). However, after reviewing this final rule, OSHA has 
determined that the standard would not impose environmental health or 
safety risks to children as set forth in E.O.13045.

XII. Environmental Impacts

    The Agency reviewed this final rule 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 determined that this final 
rule 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 this final rule will have no significant 
environmental impacts.

XIII. Summary and Explanation of the Final Rule

    This final rule is based on the public record developed during the 
rulemaking. As described in Section II, an advance notice of proposed 
rulemaking (ANPR) was published by OSHA on September 12, 2006 (71 FR 
53617). The ANPR included a series of questions to solicit information 
on a number of specific topics. The responses from more than 100 
commenters were used by the Agency to help prepare the required 
analyses for the proposed rulemaking, as well as to make determinations 
regarding the proposed text. The notice of proposed rulemaking (NPRM) 
was published by OSHA on September 29, 2009 (74 FR 50280). Public 
comments were received during a 90-day comment period that ended on 
December 29, 2009. Subsequently, public hearings were convened in March 
2010 in Washington, DC, and Pittsburgh, PA, for the Agency to receive 
oral testimony from interested parties. Following completion of the 
hearings, participants were given an opportunity to provide additional 
information to OSHA during a post-hearing comment period, as well as 
submit briefs summarizing their views for the record. The public record 
upon which OSHA is basing the final standard includes all of the 
comments, testimony, and supporting information submitted by rulemaking 
participants, as well as by OSHA.
    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 outnumbered those who opposed or questioned adoption 
(See, e.g., Document ID 0003, 0007, 0011, 0033, 0038, 0047, 
0050, 0052, 0062, 0106, 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 0038, 0046, 0059, and 0081); 
will help to ensure that employees have reliable, consistent, 
comprehensive, and comprehensible information (e.g., Document ID 
0030, 0037, and 0124); will help to enhance human health and 
the environment (improved worker safety) (e.g., Document ID 
0032, 0064, 0081, and 0128); and will reduce burdens 
associated with preparing multiple classifications and labels for the 
same product (e.g., Document ID 0030, 0048, 0080, and 0123).
    Support for implementation of the GHS by OSHA was expressed by both 
users and producers of chemicals who responded to the ANPR (See, e.g., 
Document ID 0038, 0054, 0064, and 0124). While support for 
implementation of the GHS was widespread in the ANPR 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 0032, 
0111, 0155, 0157, and 0162). 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).
    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 0004, 0065, 
0068, and 0108). These commenters argued that it would be too 
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).
    In the NPRM, OSHA addressed each of these concerns and concluded 
that evidence, arguments, and accompanying analyses supported pursuing 
the modifications to the HCS. OSHA preliminarily determined that these 
modifications would enhance employee protection and facilitate 
compliance for all workplaces that produce or use hazardous chemicals.
    While OSHA did not include questions regarding the support of 
stakeholders for adoption of the GHS, it was clear that a majority of 
those responding to the ANPR supported moving forward with the 
rulemaking. The arguments presented by those few who actively objected 
to adoption were addressed in the NPRM and the analyses for the rule, 
and were not found by OSHA to be persuasive. Other issues raised by 
supporters as concerns, or suggestions for addressing concerns, were 
also addressed in the proposed rule.
    OSHA indicated in the NPRM (74 FR 50281, Sept. 30, 2009) that the 
Agency had made a ``preliminary determination that the proposed 
modifications to the HCS would increase the quality and consistency of 
information provided to employers and employees.'' OSHA also indicated 
that the ``standardized label elements would be more effective in 
communicating hazard information;

[[Page 17689]]

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.'' Participants 
were asked if they agreed with this assessment, and also to provide 
information that reflected on the effectiveness of the proposed 
modifications in protecting employees from chemical hazards in the 
workplace.
    Many participants responded, and the vast majority agreed with 
OSHA's preliminary determination that the proposed modifications would 
be effective in protecting employees, as well as the conclusions as to 
the reasons why it would be effective, and thus supported the 
rulemaking (See, e.g., Document ID 0336, 0338, 0339, 0376, 
0377, 0382, 0402, 0403, 0404, and 0412). These commenters reflected on 
a number of different aspects regarding effectiveness when indicating 
their support. For example, in comments provided on behalf of the 
American Iron and Steel Institute (AISI) and the American Coke and Coal 
Chemicals Institute (ACCCI), it was stated (Document ID 0360):

    AISI and ACCCI support OSHA's assessment that modifications to 
the Hazard Communication Standard (HCS) would increase the quality 
and consistency of information provided to employers and employees. 
Two improvements are expected with the changes OSHA has proposed:
    a. Standardized criteria to evaluate chemicals and communicate 
the hazards via Safety Data Sheets (SDSs) and labeling should assure 
consistent communication and lower the likelihood of 
miscommunication and misinterpretation.
    b. Standardized criteria to evaluate chemicals should facilitate 
training. With a single teaching format for SDSs and Labels, 
understanding, regardless of an employee's educational background, 
should be improved.

Comments of the Society of Chemical Manufacturers and Affiliates 
(SOCMA) express support, while highlighting some of the potential 
implementation challenges that will have to be addressed (Document ID 
0402). SOCMA's comments are illustrative of those provided by 
other commenters who qualified their support by expressing issues that 
would have to be addressed in order for the benefits to occur (See 
also, e.g., Document ID 0369):

    SOCMA members are generally very supportive of the 
implementation of GHS for workplace hazard communication in the 
United States, and for over the past forty years, we have spent 
millions of dollars and dedicated an insurmountable amount of time 
towards evaluating potential chemical hazards, communicating hazard 
information and protecting workers. The proposed rule may have a 
disproportionate economic impact on small business chemical 
manufacturers, particularly companies that are already struggling in 
these unstable economic times. A majority of these burdens can be 
mitigated, though, if the most affected entities are given adequate 
time to transition and proper compliance assistance is provided.
    * * * Once overcome though, the potential benefits of 
implementing GHS in the United States are highly anticipated by 
SOCMA members, some of which include: The harmonization of 
incompatibilities and inconsistencies in labeling and 
classification, more uniformity in both substance and format, the 
elimination of language and reading barriers through pictograms, and 
the facilitation of control banding.

OSHA addresses the suggestions of SOCMA and other commenters on ways to 
mitigate implementation issues in discussions of specific provisions 
below. The Agency believes it has taken the legitimate concerns of 
stakeholders into consideration when determining the final provisions 
of this rule.
    The National Institute for Occupational Safety and Health (NIOSH) 
has extensive experience in another international effort to harmonize 
information on chemicals--development of International Chemical Safety 
Cards under the auspices of the World Health Organization (WHO) and the 
International Program on Chemical Safety (IPCS). In their comments, 
they highlighted the advantages of internationally-harmonized 
classification criteria (Document ID 0412):

    NIOSH recognizes OSHA's Hazard Communication Standard (HCS) as 
one of the most important U.S. regulations in occupational safety 
and health and concurs with OSHA on the need for a revised HCS. A 
significant advantage of the proposed standard is the detailed 
criteria for classification will improve accuracy and consistency in 
the information provided to employers and employees on chemical 
hazards and protective measures. Those criteria will reduce the 
likelihood of differing interpretations of the same data. In 
addition, the specified hazard categories will convey the severity 
of the effect, unlike the hazard classes in the current HCS.

    Worker representatives also supported the proposed rulemaking. For 
example, comments on behalf of the United Steel, Paper and Forestry, 
Rubber, Manufacturing, Energy, Allied Industrial and Service Workers 
International Union (AFL/CIO.CLC), stated (Document ID 
0403.2):

    The committees which designed the GHS agreed on an important 
principle early in the work: The final harmonized system should not 
weaken the protection afforded by any existing system. That in 
itself was a significant accomplishment. However, in the United 
States, adopting the GHS will go a step further--the revised, GHS-
compliant Hazard Communication rule will greatly improve the 
comprehensibility of labels and safety data sheets, giving workers 
and employers--especially employers in small business--information 
they can more easily understand and use.

    While stakeholder support for the rule was extensive, there were 
some stakeholders who did not support pursuing a final rule to modify 
the HCS, sought to exempt their constituents from its provisions, or 
supported a different approach. For example, the American Composite 
Manufacturers Association (ACMA) argued that the protections of the 
current rule are sufficient, and implementation of the revisions would 
be too burdensome for their industry (Document ID 0407). No 
data were provided to support these contentions. The North American 
Insulation Manufacturers Association (NAIMA) indicated they support 
harmonization, but argued that the proposed standard will not achieve 
global harmonization for a number of reasons, including conflicting 
domestic requirements (See discussion below), administrative hurdles to 
regularly revising the GHS to remain current with the international 
version, and obstacles to keeping the GHS current (Document ID 
0411). And the National Propane Gas Association (NPGA) stated 
that only those who operate in an international market will benefit, 
and that does not include the propane industry (Document ID 
0400). Similarly, the Intercontinental Chemical Corporation 
(ICC) argued that companies not involved in international trade should 
be allowed to continue complying with the existing standard, and that 
those who are involved can comply with the revised provisions (Document 
ID 0502).
    OSHA does not find any of these arguments persuasive. With regard 
to NAIMA, OSHA indicated in the NPRM how it plans to maintain the 
necessary consistency with the GHS through the various rulemaking 
options available to the Agency, and that it continues to participate 
in the international GHS activities in order to be involved in 
maintenance of the system itself. We do not agree that these are 
insurmountable concerns that argue against adopting the provisions, or 
changing the approach in a significant way.
    OSHA agrees with ACMA and ICC that the existing standard provides 
extensive protections to exposed employees. However, the analyses 
presented in support of the proposed and final rules demonstrate that 
these

[[Page 17690]]

protections could be improved by adopting the revised provisions. See 
Sections IV and VI of this document. In addition, the argument of NPGA 
that benefits only accrue to companies involved in international trade 
is not accurate. The improved protections of the rule due to 
standardization of classification criteria and harmonization of 
communication on labels and safety data sheets apply equally to 
employees of companies involved in international trade, and to those in 
companies that are not involved in such trade. Workers who use 
hazardous chemicals produced for the domestic market are entitled to 
the same level of protection as those who use chemicals produced for 
the international market, and any standard that treated them 
differently might well be inconsistent with the OSH Act. As indicated 
in the regulatory analyses for the proposed and final rules, the 
revisions are economically and technologically feasible for all 
businesses, including small businesses. See Section VI of this 
document.
    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 in responses to both the ANPR and the NPRM. 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 0047, 0080, 0104, 0123, 
0145, 0163, 0167, and 0170). For example, ORC Worldwide (Document ID 
0123) stated in ANPR comments:

    * * * OSHA 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.

    OSHA agreed with these commenters, and made every effort in the 
NPRM to maintain the framework of the current HCS in the proposed 
revisions. The modifications proposed were believed by OSHA to be those 
that were required to align the current HCS with the GHS, but did not 
address provisions of the current standard that are not addressed in 
the GHS. Thus, for example, the scope and application paragraph 
remained largely unchanged, as did the paragraph addressing trade 
secret protection. The primary modifications proposed in those 
paragraphs were changes in terminology required to ensure consistency.
    A number of commenters addressed this issue in their NPRM comments 
and testimony as well. For example, Dow Chemical Corporation indicated 
(Document ID 0353) that OSHA should follow two overarching 
principles as it revises the HCS. The first is to ``implement the GHS 
with as little US customization as possible,'' and the second is to 
``make only those changes to the HCS that are necessary to facilitate 
GHS implementation.'' (See also, e.g., Document ID 0370.) Both 
of these principles were, in fact, followed by OSHA when preparing the 
NPRM.
    Others commenters recognized this was OSHA's approach, and 
supported it. For example, the Defoamer Industry Trade Association 
(DITA) noted (Document ID 0367):

    DITA applauds the fact that OSHA did not modify the GHS 
definitions to a great degree. These definitions reflect a consensus 
scientific process for the review of the hazards that chemicals can 
present and the toxicology data that predicts the likelihood of 
hazard occurring. Accordingly, this should lead to a high level of 
harmonization on the classification of chemical substances between 
the EU and the US. A high degree of harmonization is desirable so 
that manufacturers do not need different SDSs that satisfy the 
requirements of different countries.

In the final rule, OSHA has continued to remain as consistent as 
possible with the provisions of the GHS. In general, OSHA has not 
changed the language of GHS provisions unless necessary to conform with 
the regulatory requirements of the HCS. Country-specific deviations are 
very limited, and are intended to ensure that the protections of the 
current rule are maintained in the final rule. This is consistent with 
the principle of the GHS developers that no country should have to 
reduce protections in order to harmonize. OSHA does not believe that 
any of the deviations in the final rule conflict in a substantive way 
with the GHS itself.
    Many commenters to the ANPR 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 
0048, 0050, 0053, 0076, 0104, 0111, 0123, 0134, 0154, 0162, 
and 0170). 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.

Others mentioned coordinating implementation with the Mine Safety and 
Health Administration (MSHA) (Document ID 0049, 0101, and 
0111).
    Similar comments were received in responses to the NPRM (See, e.g., 
Document ID 0344, 0345, 0350, 0351, 0375, 0376, 0403, and 
0411). 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 
78596, Dec. 29, 2006). DOT and OSHA arguably have the greatest 
interface in covered chemical products, and thus adoption of this final 
rule will result in greater consistency between these two agencies. EPA 
and CPSC have not initiated rulemaking on the GHS. However, as will be 
discussed later in this preamble, EPA and OSHA have worked together to 
develop a common position on coverage of pesticides and chemicals 
covered by the hazard communication requirements of the Toxic 
Substances Control Act's (TSCA's) significant new use rules. Clearly, 
there is no way to coordinate timelines for adoption given that OSHA is 
at the final rule stage, and neither EPA nor CPSC has started a 
rulemaking process. 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 to the ANPR also argued that OSHA should 
coordinate implementation with major U.S. trading partners (See, e.g., 
Document ID 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 
0018, 0042,

[[Page 17691]]

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.

Similar comments were received by participants in the rulemaking after 
the NPRM was published. For example, 3M indicated (Document ID 
0405):

    3M agrees that the potential benefits identified in the proposed 
NPRM may be achieved through global implementation of GHS. However, 
3M emphasizes that the potential benefits of GHS will depend on 
countries around the world aligning as closely as possible with the 
GHS. The potential benefits of GHS will be substantially undercut by 
country-specific differences or additions that would require 
companies to have multiple SDSs and labels for the same product.

Michele Sullivan, an independent consultant, recognized OSHA's approach 
as being appropriate, and argued for coordination among trading 
partners (Document ID 0382):

    Consistent implementation among the major trading partners of 
the world is crucial to realize the benefits of the GHS system. For 
this reason, the alignment, insofar as possible, of all national and 
regional GHS systems with the UN GHS system is critical. In 
addition, any national or regional GHS implementation effort must 
retain enough flexibility to continually adapt the system as 
necessary to harmonize as closely as possible with the UN GHS 
system.

    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 Sub-
committee of Experts on the GHS (UNSCEGHS), as well as the United 
Nations Institute for Training and Research (UNITAR) Programme Advisory 
Group. There is increased emphasis in the Sub-committee on 
implementation issues as well as coordination. OSHA is leading a 
correspondence group of interested members established by the Sub-
committee that is reviewing practical classification and hazard 
communication issues, and proposing modifications to the Sub-committee 
to clarify such provisions when identified. There are also other 
correspondence groups that are addressing implementation issues as they 
are raised to the Sub-committee. OSHA tries to participate in all of 
this work in the Sub-committee to help ensure that any U.S.-identified 
issues are raised and addressed. Essentially all of the countries 
involved in implementation participate in the Sub-committee, so this is 
OSHA's best opportunity to coordinate with them.
    The Agency has also had bilateral discussions with Canada, as well 
as the European Union (EU), on issues related to implementation. These 
discussions continue periodically to address mutual issues of concern.
    Canada has not yet proposed modifications to their system to 
achieve harmonization, but they are planning to in the near future. The 
EU has adopted the GHS, and according to a press release on January 4, 
2011, from the European Chemicals Agency (ECHA), recently reached a 
significant implementation milestone for its Classification, Labelling 
and Packaging (CLP) regulation. (http://echa.europa.eu/news/pr/201101/pr_11_01_clp_deadline_20110104_en.asp):

    By 3 January 2011, ECHA received 3,114,835 notifications of 
24,529 substances for the Classification and Labelling Inventory. By 
this deadline, industry had to notify the classification and 
labelling of all chemical substances that are hazardous or subject 
to registration under the REACH regulation and placed on the EU 
market. * * *
    The Classification, Labelling and Packaging regulation relates 
to chemical substances and mixtures. It introduces into the EU the 
criteria of the United Nations' Globally Harmonised System for 
classifying and labelling chemicals. One of the aims of the CLP 
regulation is to improve the protection of human health and the 
environment by providing criteria for defining when a substance or 
mixture displays properties that lead to its classification as 
hazardous.
    CLP applies to manufacturers, importers, users or distributors 
of chemical substances or mixtures. They must classify, label and 
package any substance or mixture, regardless of its annual tonnage, 
in accordance with the Regulation.
    The largest number of the notifications, over 800,000, came from 
Germany. Over 500,000 notifications were submitted from the United 
Kingdom and nearly 300,000 from France. All together over 6,600 
companies notified at least one substance.

    Canada and the EU are two of the major trading partners for the 
U.S. When OSHA prepared the NPRM, it examined the CLP 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 
and the final rule are based on Revision 3 of the GHS. Revision 3 was 
adopted by the UN Committee and Sub-Committee of Experts on the GHS in 
December 2008, and is available as a publication and on the UN Web 
site. In December 2010, the UN Committee and Sub-committee of Experts 
on the GHS adopted additional changes that will be issued as Revision 
4.
    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, other rulemaking options are available that can 
be utilized to implement the changes 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 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.
    A number of NPRM participants commented that OSHA should establish 
a stakeholder process for input into U.S. government positions on 
issues raised at

[[Page 17692]]

the UN (See, e.g., Document ID 0376, 0377, 0381, 0382, and 
0411). OSHA is always open to receiving suggestions from stakeholders 
regarding issues raised in the UN process. The working papers are made 
publicly available on the UN Web site some 12 weeks before meetings. 
Public meetings are scheduled to receive input in some situations, and 
stakeholders may also contact the primary OSHA delegate directly to 
discuss any of the issues raised. Stakeholders can participate in the 
Sub-committee discussions directly as well through organizations that 
have recognized status in the Sub-committee. As already noted, changes 
to the OSHA HCS as a result of modifications to the GHS in the future 
will be subject to a public rulemaking process where all stakeholders 
have the opportunity to participate.
    In the NPRM (74 FR 50288, Sept. 30, 2009), OSHA noted that one 
advantage of adopting a system with harmonized hazard statements is 
that it would facilitate the use of ``control banding'' in the U.S. 
Control banding is an approach to selecting control measures for 
workplace chemical exposures. Basically, the employer can, with the use 
of information readily available in the workplace, use the approach to 
determine the appropriate control measures for a chemical. The 
harmonized hazard statements are key to assessing the hazards, and the 
degree of severity of the hazards. In combination with data about 
physical and chemical characteristics, quantities used, and the types 
of processing, the employer can access recommended control measures. It 
is particularly helpful in situations with common operations (e.g., 
bagging operations), and chemicals with well-known hazards that are not 
severe (e.g., it would not generally be applied to a carcinogen--the 
control banding guidance would inform the employer that professional 
assistance must be acquired to address such a hazard). Control banding 
has been used successfully by small and medium-sized businesses that 
don't have extensive health and safety expertise in these types of 
situations.
    There is considerable international interest in this approach, and 
there have been a number of research studies conducted to refine the 
approach and determine its applicability. Both OSHA and NIOSH have 
taken part in activities to further investigate its utility in the U.S. 
NIOSH has extensive information available on its Web site at http://www.cdc.gov/niosh/topics/ctrlbanding/. As they indicated in their 
comments (Document ID 0412):

    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 United 
States to help small- and medium-sized employers select and 
implement appropriate control measures [NIOSH 2009].

The American Society of Safety Engineers (Document ID 0336) is 
also a strong proponent of control banding. However, their position was 
that OSHA should have included control banding in the NPRM, and thus in 
the HCS:

    * * * ASSE believes OSHA should update the HCS to incorporate 
elements of control banding. Assuming that most elements of GHS will 
be adopted and a national database for safety data sheets (SDSs) and 
chemical classifications will be established to support the 
transition to GHS from current practice, building a system that 
would allow guided review of materials and processes such as control 
banding would be a relatively small additional step. We encourage 
OSHA to take that step now and avoid revisiting this issue when it 
becomes unavoidable as control banding grows in use internationally 
as well among leading employers in this nation.

While OSHA agrees with ASSE that control banding may be a very useful 
approach to controlling workplace exposures to chemicals, it does not 
agree that this rulemaking is the appropriate place to address this 
issue. As noted by both OSHA and NIOSH, adoption of the GHS will 
facilitate the use of control banding in the U.S. by making harmonized 
hazard statements readily available on labels and SDSs. This will allow 
the adaptation of the approach in a way that could not be readily 
accomplished with the current performance orientation of the HCS. 
However, it is generally viewed as a guidance approach where it is 
currently used, and not a mandatory requirement. Furthermore, control 
banding continues to be refined in terms of application, and is not 
harmonized. Adoption of it in the HCS would also not be consistent with 
the principles OSHA has followed in devising the NPRM, i.e., to limit 
changes to those required to align with the GHS, and to be as 
consistent as possible with the GHS provisions. Therefore, while OSHA 
believes the utility of control banding should continue to be assessed 
and evaluated in the U.S., it is premature to consider the approach as 
a mandatory requirement and part of the revised HCS.
    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 ANPR commenters (See, e.g., Document ID 
0018, 0025, 0047, 0065, 0081, 0104, and 0154), OSHA will 
continue working with 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.
    OSHA solicited additional ideas for outreach or compliance 
assistance in the NPRM, and many commenters provided such information 
(See, e.g., Document ID 0332, 0344, 0356, 0370, 0382, 0405, 
0408, 0410, and 0414). There was a wide range of suggestions, including 
training programs, workshops, web resources, and enforcement tools 
addressing different aspects of the modified standard. OSHA has already 
developed some compliance assistance products--or updated products 
available for the existing standard--and will be developing and 
distributing these and others as resources are made available. There 
are also tools being developed internationally that will be available 
for employers undertaking compliance, such as training materials in 
preparation by the United Nations Institute for Training and Research 
(UNITAR). OSHA has provided support to this activity, and expects these 
materials will be made available on its Web site when completed. OSHA 
encourages trade associations, professional societies, and others to 
develop materials that are specific to certain interest groups or 
industries, thus providing a more focused compliance assistance 
approach than can be done by OSHA at the national level.
    The final standard. The following is a description of the 
provisions of the final standard, along with a discussion of what was 
proposed and the information provided by rulemaking participants. As 
noted above (and supported by rulemaking participants), OSHA's approach 
has been to confine changes to the standard to those required to align 
it with the GHS. Therefore, provisions that do not require changes for 
that purpose have been left the way they are in the current HCS. While 
participants supported this approach in general, suggestions were made 
that involved changes to the current text in areas unaffected by the 
GHS. Since OSHA did not propose to

[[Page 17693]]

open these parts of the rule in the proposed rulemaking, and the 
analyses did not involve such changes, the Agency will not be adopting 
them in the final rule.
    Similarly, as OSHA indicated in the NPRM, the Agency's approach was 
also to be as consistent as possible with the GHS itself. Editing was 
limited to what was required to make the provisions mandatory in the 
context of OSHA rulemaking, and using the regulatory language required 
for that purpose. Additionally, as described in the NPRM, OSHA did not 
propose adopting language from the GHS that was strictly provided for 
guidance purposes (such as the decision logics in the chapters in the 
GHS that describe the physical and health hazard criteria). There is no 
question that other changes could be made to the language to make it 
more readable, or to state it in American English. However, introducing 
different terminology also introduces the possibility that readers will 
believe that OSHA means something different than the GHS because we 
have used different language. Since this is not the intent, the Agency 
has avoided doing this.
    Nevertheless, many such editorial changes were suggested. While 
OSHA has reviewed all of them, and adopted a few that seemed 
appropriate or necessary, in general the Agency did not engage in 
extensive editing of agreed text for fear of changing the meaning, or 
giving the impression that the meaning has changed. In particular, Dow 
Chemical submitted extensive suggested edits in both its initial 
comments on the NPRM and in post-hearing comments (Document ID 
0353 and 0526). Most of these issues were not raised by any 
other participants. Given the large number of such editorial 
suggestions from Dow, OSHA does not discuss each one in this preamble, 
but simply notes where changes have been made to the text. OSHA, 
however, gave each of Dow's suggestions full consideration.
    (a) Purpose. The HCS includes a paragraph that states the purpose 
of the rule. This stated purpose is two-fold. First, the paragraph 
indicates that the standard addresses assessment of the hazards of 
workplace chemicals, and the transmittal of that information to 
employers and employees. It also describes the contents of a 
comprehensive hazard communication program as being container labeling 
and other forms of warning, material safety data sheets, and employee 
training.
    The second part of the paragraph addresses the preemption of State 
or local laws by this Federal standard. It indicates that OSHA is 
addressing comprehensively the issues described, and thus the standard 
preempts States, and political subdivisions of States, from addressing 
these issues except under the authority of a Federally-approved State 
plan under Section 18 of the OSH Act. While Section 18 applies to every 
occupational safety and health standard that OSHA promulgates, the HCS 
raises particular issues because of the nature of the provisions. It 
requires chemical manufacturers and importers to evaluate the hazards 
of the chemicals they produce or import, and to prepare labels and 
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 revisions to the HCS had essentially the same 
purposes, and thus the NPRM included only minor modifications to this 
paragraph. OSHA proposed to modify paragraph (a)(1) to 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 proposed 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'' was modified to ``safety data sheet'' to reflect the 
terminology of the GHS.
    The only modifications proposed to paragraph (a)(2) also addressed 
terminology, using ``classifying'' instead of ``evaluating'', and 
``safety data sheet'' instead of ``material safety data sheet''.
    There were a few comments that were related to the Purpose 
paragraph provisions. 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 0111, 0134, 0164, and 0178). 
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 in the NPRM. While the current HCS and this 
final standard require 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. An employer should use 
all available information when designing an appropriate protective 
program, 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 classification of the hazards of chemicals as a result 
of 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 final 
rule 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 provide additional information for the downstream user, but 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 final 
rule 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

[[Page 17694]]

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 to the ANPR noted what they believed to be the 
continued need to address the preemption of State standards (See, e.g., 
Document ID 0036, 0048, 0056, 0080, 0123, 0135, and 0178). 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 0015, 0038, 
0042, and 0072).
    It was also indicated that changes in State laws should be 
coordinated with the Federal changes to facilitate implementation 
(Document ID 0146). See Section VIII and IX of this preamble 
for a comprehensive discussion regarding Federalism and State plans.
    There were a number of comments received in response to the NPRM 
that addressed the Purpose paragraph provisions. For example, the 
Styrene Information and Research Center (Document ID 0361) 
indicated that OSHA should revise paragraph (a)(1) to say that it is 
intended to be consistent with the GHS ``with some exceptions,'' since 
there are some deviations from the GHS. OSHA does not agree with this 
suggestion. The language proposed, and in the final rule, is accurate--
it is consistent with the provisions of the GHS. The GHS is not a model 
regulation, and it is not intended that countries will adopt the actual 
text of the GHS. Furthermore, there is allowance for flexibility and 
differences where necessary to accommodate a country's specific needs. 
There was nothing in the NPRM that was inconsistent with the GHS, and 
neither is the final rule inconsistent.
    Dow Chemical (Document ID 0353), argued that paragraph 
(a)(2) should state that OSHA is preempting personal injury suits 
alleging that labels provided inadequate warnings. The Industrial 
Minerals Association-North America (Document ID 0394) 
indicates that the new rule must make clear that it preempts state law 
tort claims alleging failure to warn. OSHA declines these invitations. 
As recently explained in the Solicitor of Labor's letter to Stephen 
Wodka, dated October 18, 2011, in general the HCS does not preempt 
state tort failure to warn lawsuits, and OSHA does not intend to change 
that position in the final rule. Indeed, the OSH Act's ``savings 
clause'' explicitly preserves, rather than preempts, State tort law. 
OSH Act Sec.  4(b)(4), 29 U.S.C. 653(b)(4); Lindsey v. Caterpiller, 
Inc., 480 F.3d 202, 209 (3d Cir. 2007); Pedraza v. Shell Oil Co., 942 
F.2d 48, 53-54 (1st Cir. 1991). While a limited preemption might be 
possible to the extent a state tort rule directly conflicted with the 
requirements of the standard, no commenter has provided any evidence of 
such a conflict. For example, the record contains no evidence that a 
manufacturer might be held liable under a State's tort law rules for 
complying with the GHS. However, to eliminate any confusion about the 
standard's preemptive effect, and to be consistent with the President's 
May 20, 2009 Memorandum on Preemption, OSHA has made two small changes 
to (a)(2) in the final rule, changing the words ``legal requirements'' 
to ``legislative or regulatory enactments'' in the provision's first 
sentence and eliminating the words ``through any court or agency'' in 
the last sentence.
    Similarly, DuPont (Document ID 0329) says OSHA should 
convince States to voluntarily rescind their ``right-to-know'' laws, or 
make them consistent with the HCS final rule. And the National Paint 
and Coatings Association (NPCA) (Document ID 0328) believes 
that OSHA should not allow States to promulgate a standard that is 
different from the Federal rule. As indicated in paragraph (a)(2), 
States with OSHA-approved State Plans will have to adopt standards that 
are at least as effective as this final rule. (See, generally, 62 FR 
31159, Jun. 6, 1997.) Those standards will be reviewed by Federal OSHA. 
Other States are preempted from covering these areas with regard to 
workplace protections. OSHA has no authority with regard to provisions 
that are intended to address non-workplace situations.
    Therefore, OSHA has concluded that the changes it proposed to 
Paragraph (a) are appropriate, and those changes are being incorporated 
into the final rule. No other revisions are being made.
    (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.
    In general, OSHA does not expect significant changes in the 
chemicals covered by the HCS under the final rule 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 that many manufacturers 
follow in their labeling programs (ANSI Z400.1/Z129.1-2010, Hazardous 
Chemicals--Hazard Evaluation and Safety Data Sheet and Precautionary 
Labeling Preparation), 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 
final rule 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 the strict percentage cut-off of 1% in 
the current HCS. Other definitions of health hazards would maintain the 
current broad HCS scope.
    In addition to the overall scope statement, the final rule, like 
the current rule, provides for limited coverage in workplace situations 
that have special circumstances, including laboratories (paragraph 
(b)(3)) and work operations where employees only handle chemicals in 
closed containers (paragraph (b)(4)).
    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) 
(paragraph (b)(5)), or completely exempting the product (such as 
hazardous waste regulated by EPA) (paragraph (b)(6)). These 
accommodations help to ensure that

[[Page 17695]]

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 reviewed the current provisions of paragraph (b), and 
determined that no significant changes were required to be consistent 
with the GHS. Several minor changes to revise terminology were retained 
from the proposal (i.e., adopting the terms ``classifying'' and 
``safety data sheets''), but OSHA is not modifying 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). The Sheet 
Metal and Air Conditioning Contractors National Association (SMACNA) 
(Document ID 0415) suggested in response to the NPRM that OSHA 
update Appendix E and continue to include it in the standard. OSHA will 
update Appendix E, and make it available as a compliance assistance 
product. It was always available as a pamphlet in any event, and has 
been very useful in helping small employers who are users of chemicals 
comply with the standard. And as noted above, new outreach and 
compliance assistance materials are being prepared as well.
    Several commenters to the ANPR 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 
0049, 0134, and 0164). In response to the NPRM, the Society of 
the Plastics Industry (SPI) (Document ID 0392) continued to 
argue that the EU exemptions should be adopted. All of these situations 
are already addressed in paragraph (b), and OSHA does not agree that it 
is appropriate or necessary to change them.
    In terms of non-isolated intermediates, the overall scope provision 
in paragraph (b)(2) adequately addresses this situation. This was 
described in the preamble to the 1983 final rule (48 FR 53335, Nov. 25, 
1983):

    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).
    The North American Metals Council (NAMC) (Document ID 
0377) argued in response to the NPRM that OSHA should use the 
EU approach to exempt metals in their massive form, alloys, and other 
preparations that do not present a hazard. Provisions already exist in 
the current HCS, and are included in the final rule, that address these 
issues (See, e.g., definition of article (paragraph (c)), special 
labeling provisions for solid metals (paragraph (f)(4))).
    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 revised rule. The Agency is not 
changing those parts of the HCS that are not affected by the GHS.
    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 0072 and 0179). OSHA 
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 continue to 
voluntarily include such data on their labels and safety data sheets to 
meet the requests of their domestic and international customers. 
Commenters to the NPRM continued to state that OSHA should allow 
environmental information although it is not required (Document ID 
0344 and 0381). OSHA maintains the position proposed that 
manufacturers are free to provide additional information on labels and 
safety data sheets to address environmental concerns, as well as 
aspects of concern in other areas such as transportation. (74 FR 50387, 
Sept. 30, 2009)
    Few comments were received on this paragraph in the NPRM. Dow 
Chemical (Document ID 0353) suggested that paragraph 
(b)(5)(iv) be updated to reflect the changed name of the Bureau of 
Alcohol, Tobacco, Firearms, and Explosives (the word ``Explosives'' has 
been added to their name). This has been done. In addition, two 
typographical errors in (b)(6)(ii) have been corrected.
    The North American Insulation Manufacturers Association (NAIMA) 
(Document ID 0411) states that OSHA has given unwarranted 
exemption by ceding authority for products regulated by other agencies. 
In particular, NAIMA is concerned about coverage by CPSC, and indicates 
that CPSC addresses the fire hazards of cellulose insulation, but not 
the health hazards, in its label requirements. NAIMA argues that OSHA 
should not allow consumer product labels to supersede OSHA 
requirements.
    OSHA considered this issue at length in previous amendments to the 
HCS (53 FR 29822, 29834-38, Aug. 8, 1988; 59 FR 6126, 6150-52, Feb. 9, 
1994; See also 52 FR 31852, 31862-63, Aug. 24, 1987). After noting that 
CPSC labels often do not contain all hazard information relevant to 
worker exposures, OSHA concluded that:

    OSHA nevertheless decided to permit the CPSC labels to suffice 
so as not to disrupt the extensive labeling conducted in accordance 
with those rules. OSHA believed that this could be justified on the 
basis that some information is provided on the labels that would be 
useful to workers, and that the requirement for MSDSs would provide 
what information is necessary to supplement the labels. 48 FR 53289. 
This additional information is critical to ensuring that training 
can be properly conducted, and that adequate protective measures are 
used in the workplace.

(53 FR 29834, Aug. 8, 1988; See also 59 FR 6151, Feb. 9, 1994.) Thus, 
under the current HCS, SDSs and employee training are required where 
employee exposure to a consumer product exceeds

[[Page 17696]]

the range that ``could reasonably be experienced by consumers when used 
for the purpose intended.'' 29 CFR 1910.1200(b)(6)(ix). OSHA sees no 
need to revisit this issue now, and in any event it is outside the 
scope of this rulemaking, which is aimed at the changes necessary to 
bring the HCS in conformity with the GHS.
    A few comments were received in response to the ANPR 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), which also 
controls the SDS content (Document ID 0108). A commenter also 
argued that FIFRA pesticide labels are more useful because they are 
risk-based rather than hazard-based (Document ID 0108). These 
concerns were not related to the proposal which maintained 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 as adopted in this final standard.
    A number of additional comments, and oral testimony, were received 
in response to the NPRM from representatives of the pesticide industry 
regarding potential conflicts between OSHA and EPA requirements (See, 
e.g., Document ID 0352, 0385, 0387, and 0468). OSHA does not 
require additional labels on pesticides that require labels under EPA 
requirements. However, OSHA does have SDS requirements that must still 
be applied, and have been applied since the HCS first went into effect. 
Pesticide industry representatives believe that the SDS requirements as 
aligned with the GHS would conflict with the EPA-approved labels 
because they may have different information on them for OSHA than what 
is included in the pesticide label. For example, EPA has three signal 
words for pesticides (danger, caution, and warning), while OSHA will 
have the two specified by the GHS (danger and warning). There are also 
other differences. For example, chronic health effects are rarely 
addressed on pesticide labels as the risk mitigation measures are 
intended to minimize the possibility of their occurrence. However, OSHA 
would require such effects to be included when appropriate. The 
commenters also argue that EPA ``labels'' include any information 
related to the product, and thus SDSs would be preempted by the EPA 
labeling requirements. Therefore, they argue that pesticides should be 
exempted from the HCS. For example, the American Chemistry Council's 
Biocides Panel says the reasons for exempting pesticides are as follows 
(Document ID 0385):

    The principal reasons for this are: (i) Requiring GHS compliant 
SDS's but not pesticide labels will result in significant confusion 
in workplaces in which pesticides are used; (ii) imposing GHS-based 
SDS's would be inconsistent with EPA's interpretation of FIFRA, 
which includes all material that may be shipped with a pesticide, 
including SDS's, as part of its definition of labeling; and (iii) 
applying GHS to pesticide SDS's will not provide any additional 
substantive information, as EPA's evaluation of pesticides before 
approving them for sale includes all aspects of potential 
occupational exposures.

    OSHA considered exempting pesticides from the final rule. However, 
exempting pesticides would reduce protections for those workers under 
OSHA's jurisdiction. For example, OSHA's jurisdiction extends to 
employees in pesticide manufacture and formulation. While EPA approves 
the label on the final product shipped out of these facilities, and 
that label includes information needed when the products are used by 
applicators, EPA does not have hazard communication requirements for 
the protection of workers in production facilities. Such protection is 
covered by OSHA, and OSHA requires labels on containers that are not 
subject to EPA labeling, as well as SDSs and training. The workplace 
exposures of these workers are of great concern. The chemicals are 
generally designed to be biologically active, and the exposures can be 
quite different than they would be for applicators, for example, who 
may use them only on an intermittent basis.
    In testimony during the public hearing, representatives from the 
ACC Biocides Panel and CropLife America, Inc., agreed that EPA does not 
cover workers in pesticide manufacturing or formulating facilities (See 
Document ID 0495 Tr. 248-250). An exemption from the HCS would 
provide reduced protection for these workers.
    As a result of receiving these comments, and the concerns about 
removing current protections from the final rule, OSHA considered 
several options. OSHA considered allowing the SDS preparer to use the 
EPA classification in section 2 of the SDS to ensure consistency with 
the FIFRA label. However, in doing this the SDS would then be 
inconsistent with other chemicals in the production of pesticides. In 
the pesticide manufacturing workplace the pesticide chemical ``active'' 
ingredients would bear a FIFRA label but would have an OSHA SDS, 
however other chemicals in the workplace such the ``inactive'' 
ingredients or cleaning products might still be considered hazardous 
under the HCS would contain an OSHA label and an OSHA SDS. An added 
complication is that an identical chemical (for example, chlorine) 
could potentially be in a pesticide manufacturing workplace where in 
one situation it could contain a FIFRA label and another it could bear 
an OSHA style label depending on its end use (e.g., a disinfectant). 
Adding a different SDS would create additional confusion not only for 
the worker handling the chemicals but also the personnel in charge of 
chemical management as well. Therefore, OSHA and EPA met to discuss 
what would be an appropriate resolution. First, with regard to the 
argument that SDSs are part of labels, and therefore preempted, EPA has 
long had an interpretation that they will not apply their review 
requirements to SDSs (US EPA Pesticide Registration Notices 92-04). 
Based on our discussions, OSHA does not anticipate that this policy 
will change. Secondly, EPA has indicated that they are committed to 
working with OSHA to develop an approach that will provide both 
appropriate protection for employees, as well as the environment, 
through workable guidance for the pesticide industry. OSHA anticipates 
that EPA will provide guidance to their regulated community (such as 
through a Pesticide Registration Notice) on how to develop an OSHA GHS-
compliant SDS that will not be in conflict with the pesticide label. 
Therefore, pesticides will continue to be covered in the same manner as 
has been done under the HCS since its inception, and the exemption 
requested by pesticides industry rulemaking participants for such 
products is not granted.
    Although the OSHA ICR (OMB Control No. 1218-0072) that is currently 
pending review and approval by OMB addresses the information collection 
activities associated with preparing the entire SDS as prescribed by 
the OSHA final rule, the approach OSHA anticipates will be provided in 
the EPA guidance for pesticide registrants was not considered by OSHA 
at the proposed rule stage. While OSHA preliminarily believes it has 
taken sufficient time in its paperwork estimate to cover compliance 
with the anticipated EPA guidance, the public has not had the 
opportunity to comment

[[Page 17697]]

on the paperwork burdens created by that guidance. As such, EPA and 
OSHA are collaborating on a subsequent revision to OSHA's ICR to ensure 
that it addresses the activities in the EPA guidance. EPA intends to 
solicit public comment on an ICR revision that addresses the 
information collection activities and related burden estimates 
associated with the EPA guidance as part of its release of that 
guidance. After public comments are considered by both agencies, OSHA 
intends to ask OMB to revise its ICR approval, identified under OMB 
Control No. 1218-0072, to capture the information collection activities 
and burden adjustments, if any, related to EPA's guidance.
    (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 retained as many definitions as 
possible from the current HCS. Changes were proposed only when there 
was a new term used that needed to be defined, or there is a different 
definition in the GHS, and consistency with the international 
definition was needed for harmonization purposes. As with the preceding 
paragraphs, minor modifications were proposed to ensure terminology is 
appropriate--primarily the use of terms related to classification and 
safety data sheets. These modifications were retained in the final 
rule. There were relatively few comments submitted on the proposed 
revisions to the definitions, other than those referring to the new 
definition OSHA proposed to address ``unclassified hazards'' and the 
definition for ``pictogram'' that references a red border frame.
    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 retain 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 regulatory text of the final standard, similar to its 
use in the current HCS. However, the 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.'' Dow Chemical (Document ID 0353) 
objected to this definition, and suggested that it should be ``chemical 
elements and compounds in their natural state or obtained by any 
production process.'' OSHA has concluded that it is appropriate to 
maintain the GHS language for this definition to help to ensure 
consistent application, and thus the revised rule includes the 
definition of substance that was proposed.
    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. Dow Chemical 
(Document ID 0353) suggested that OSHA maintain part of its 
current definition in order to avoid inadvertently changing the scope 
of coverage by adding ``if the combination is not, in whole or in part, 
the result of a chemical reaction.'' OSHA does not believe that the 
scope is changed by the GHS definition, and has retained the GHS-
consistent language that was proposed.
    OSHA also proposed to maintain the term ``hazardous chemical'' in 
this revised standard 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. OSHA also proposed to include unclassified hazards in this 
definition, but, as will be described below, has chosen a different 
approach in the final rule. Instead, the definition of ``hazardous 
chemical'' in this final rule is ``any chemical which is classified as 
a physical hazard or a health hazard, a simple asphyxiant, combustible 
dust, pyrophoric gas, or hazard not otherwise classified.'' The term is 
used throughout the standard to indicate that the classification 
process is completed, and the chemical manufacturer has determined that 
the chemical poses a hazard. Most of the substantive requirements of 
the rule apply to hazardous chemicals.
    Dow Chemical (Document ID 0353) indicated that OSHA should 
drop the use of the word ``substance'' altogether, and instead use the 
word ``chemical.'' As noted in the definition of ``chemical,'' however, 
it is to be used when a reference is to both substances and mixtures. 
Where a provision or statement refers only to a substance, or only to a 
mixture, those terms are used in lieu of ``chemical'' or ``hazardous 
chemical.'' These individual designations are used most commonly in the 
appendixes, particularly in the classification criteria. OSHA has 
maintained consistency in the criteria with the GHS insofar as is 
possible with regard to this terminology.
    Another proposed modification to the definitions paragraph was to 
move the specific physical hazard definitions to an appendix. In the 
current HCS, health hazard definitions are addressed specifically in 
Appendix A, but the physical hazard definitions were included in 
paragraph (c). In the final standard, health hazard definitions 
continue to be addressed in Appendix A, but a new Appendix B addresses 
physical hazards. Both of these appendixes are discussed below under 
the summary and explanation of paragraph (d) ``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 already 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.

[[Page 17698]]

    OSHA also has updated the definition of the term ``classification'' 
to reflect the additional hazards in this final rule (simple 
asphyxiant, combustible dust, and pyrophoric gas). The definition for 
classification will now read: ``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 according to the 
definition of hazardous chemical in this section. In addition, 
classification for health and physical hazards include the 
determination of the degree of hazard, where appropriate, by comparing 
the data with the criteria for health and physical hazards,'' Dow 
Chemical (Document ID 0353) suggested that the language be 
changed to read ``for health hazards and for physical hazards.'' OSHA 
does not find this to be a necessary revision, and has adopted the 
definition as proposed. 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.
    OSHA has also retained in the final rule the proposed definitions 
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, oral acute 
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.'' Both of these 
definitions are taken from the GHS. Dow Chemical (Document ID 
0353) suggested that the last sentence of the definition of 
``hazard category'' should be deleted or moved to Appendix A because it 
is ``non-definitional information.'' Given that it is included in the 
GHS definition, OSHA has adopted it in the final standard.
    OSHA has retained the proposed definition of ``health hazard'' to 
reflect the specific hazards defined in the GHS. While the overall 
scope of what is covered is 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'' was 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 
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.''
    Both the American Chemistry Council (ACC) (Document ID 
0393) and Dow Chemical (Document ID 0353) suggested 
that OSHA modify the phrase ``any route of exposure,'' which refers to 
``acute toxicity.'' ACC suggested it list the three specific routes of 
exposure in the criteria, and Dow suggested that it include 
``relevant'' to modify routes of exposures. OSHA does not believe 
either of these changes is necessary. The definition already uses the 
term ``classified'' to refer to each of the health hazards listed, and 
the acute toxicity criteria include three routes of exposure for 
classification. Dow further suggested that ``serious eye damage'' be 
modified to say ``by chemical action.'' Again, the classification 
process is for chemicals, and the definition already indicates that it 
is covered as a health hazard when classified. Similarly, Dow suggested 
that ``aspiration hazard'' be modified to say ``aspiration toxicity 
hazard.'' The proposed language is consistent with the GHS, and OSHA is 
maintaining it for harmonization purposes in the final standard.
    A revised definition of ``physical hazard'' was proposed to reflect 
the physical hazards covered in the GHS. While these are similar to the 
coverage of the HCS, they are in some cases described differently. The 
definition proposed for ``physical hazard'' is ``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.'' This definition has been adopted 
in the final standard with one change. OSHA did not include pyrophoric 
gas in the definition in the proposal. There is no definition for 
pyrophoric gas in the GHS, which is covered under the current HCS, and 
OSHA inadvertently left it out in the proposed standard when the 
generic definition for pyrophorics was removed. This omission was 
pointed out by commenters (e.g., Document ID 0382 and 0530). 
OSHA is therefore returning the pyrophoric gas definition from the 
current rule to paragraph (c), and making it specific to just gases 
since the current rule covers all physical states. Thus, pyrophoric gas 
is defined as ``a chemical in a gaseous state that will ignite 
spontaneously in air at a temperature of 130 degrees F (54.4 degrees C) 
or below.'' Label elements are provided in C.4.30. The signal word will 
be danger; the pictogram is the flame; and the hazard statement is 
``Catches fire spontaneously if exposed to air.''
    Procter & Gamble (Document ID 0381) noted that the 
definition for ``flashpoint'' was missing from the NPRM and suggested 
that it should be put back into the rule. However, the meaning of the 
term ``flashpoint'' is already addressed in the criteria for 
``flammable liquid'' in Appendix B by specifying the test methods to 
determine it. OSHA has also included a definition for flashpoint in the 
criteria chapter, rather than in the definitions paragraph.
    The definition of ``label'' in the GHS is slightly different than 
what is currently in the HCS, and OSHA proposed to modify the HCS to be 
consistent with the GHS. The proposed definition of ``label,'' which 
has been retained in the final rule, 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 the current HCS, 
and includes certain core information that must be presented. Thus, a 
definition for ``label elements'' was also proposed and adopted in the 
final rule as ``the specified pictogram, hazard statement,

[[Page 17699]]

signal word, and precautionary statement for each hazard class and 
category.'' ACC (Document ID 0393) noted that this definition 
is different from what is in the GHS. OSHA modified the definition by 
making it plural to reflect the way it is used in this section to refer 
to the OSHA-required label elements for each GHS label. The GHS 
definition in this case defines the singular term ``label element'' as 
``one type of information that has been harmonized for use in a label, 
e.g., pictogram, signal word.'' OSHA has listed all of the label 
elements, including precautionary statements since they are mandatory 
under the revised rule. OSHA believes its definition is consistent with 
the GHS but more appropriate for the revised rule, and has adopted it 
in this final standard.
    ``Safety data sheet (SDS)'' is defined in both the NPRM and the 
final rule 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 were also proposed to be added to the HCS and are 
included in the final rule. These terms include ``hazard statement,'' 
``pictogram,'' ``precautionary statement,'' ``product identifier,'' and 
``signal word.'' These 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. The definition for ``hazard statement'' is 
being adopted as proposed.
    There were a few comments about specific hazard statements, such as 
an objection from the National Propane Gas Association (Document ID 
0400) indicating the statement for flammable gas is ambiguous, 
and lacks substantiation and scientific credence. They object to 
labeling propane as ``extremely flammable,'' which is the required 
statement for Category 1 for flammability hazards. This objection was 
also raised in a comment to the ANPR (Document ID 0068). OSHA 
responded in the NPRM that it would not be making chemical-specific 
changes to hazard statements (74 FR 50399, Sept. 30, 2009). The point 
of having harmonized statements is that all chemicals with the same 
degree of hazard have the same statement. OSHA also indicated that some 
in the industry already use the ``extremely flammable'' terminology. 
NPGA responded that not everyone is familiar with it, or uses it. That 
is why OSHA is establishing a standardized approach, so everyone in an 
industry with a common product like propane uses the same language to 
convey the hazard. This consistency will help people understand what 
the hazards are, and simplify the process of conveying them since 
everyone will use the same approach. As noted previously, examples of 
where the hazard statement ``extremely flammable'' are currently being 
used for propane are readily found (e.g., Document ID 0554). 
Therefore, OSHA does not agree with NPGA that the hazard statement is 
inappropriate or should be modified.
    A few commenters suggested that where hazard statements include two 
hazards, separating them should be permitted when data indicate that 
only one is applicable to the product involved (for example, it causes 
infertility but not developmental hazards) (Document ID 0344, 
0376, 0377, 0381, 0382, and 0393). OSHA agrees that such separation 
should be permitted. The following provision has been added to Appendix 
C.2.2.2: ``If the chemical manufacturer, importer, or responsible party 
can demonstrate that all or part of the hazard statement is 
inappropriate to a specific substance or mixture, the corresponding 
statement may be omitted from the label.''
    Additionally, OSHA permits chemical manufacturers and importers to 
combine hazard statements where the information is related and the 
combination can shorten the text required on the label. Appendix 
C.2.2.1 states: ``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.'' OSHA also allows 
additional hazard statements under supplementary information, as long 
as they are accurate and do not conflict with the required statements. 
``Pictogram'' is defined as 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. ACC (Document ID 
0393) and Procter & Gamble (Document ID 0381) noted 
that the proposed definition of pictogram, which was retained in the 
final rule, is slightly different than what is in the GHS: ``a 
graphical 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.'' OSHA added ``about the 
hazards of a chemical'' because that is the only type of information 
that will be conveyed by the pictograms in the HCS. The definition is 
being adopted as proposed.
    The workplace pictograms proposed were a black symbol on a white 
background with a red diamond border frame. Some ANPR commenters noted 
that the frame should be permitted to be black for domestic shipments 
as allowed under the GHS (See, e.g., Document ID 0032 and 
0163). However, as described in Section IV of the proposed preamble, 
there are clear safety and health benefits associated with the use of 
the red frame in terms of recognition and comprehensibility. Thus OSHA 
proposed to allow only the red frame to be used, whether the shipment 
is domestic or international.
    Many of the rulemaking participants recognized the communication 
benefits of the red border, and supported the proposed requirement for 
a red border frame for all shipments (See, e.g., Document ID 
0313, 0324, 0330, 0335, 0336, 0339, 0341, 0365, 0383, 0408, 
0410, 0412, and 0456). For example, Product Safety Solutions (Document 
ID 0313) stated:

    OSHA requests comment on whether pictogram borders should be 
required to be in red or should be allowed to be printed in black. 
While the use of a red border may increase the cost of printing some 
labels, the use of color to draw attention to a potential hazard is 
a useful tool and is likely to enhance the communication of safety 
information. As products may also be exported to other countries, 
the use of the red border would be consistent with the establishment 
of a globally recognized hazard symbol. Imported products likewise, 
would have to contain the red symbol border and this would have to 
be made abundantly clear to Customs Agents and others responsible 
for monitoring the importation of chemical products.


[[Page 17700]]


    However, others argued that black frames should be permitted on 
domestic shipments, and that the use of red borders is too costly and 
burdensome in terms of printing costs in particular (See, e.g., 
Document ID 0328, 0338, 0344, 0352, 0370, 0376, 0389, 0399, 
0405, and 0411). For example, ISSA (Document ID 0399) claims:

    If OSHA were to require only the red frame for pictograms, it 
would require those formulators that presently print single color 
labels to utilize different systems for producing labels of this 
nature, requiring a substantial capital investment which in turn 
will add greatly to the cost of transitioning to the revised HCS. 
OSHA must keep in mind, that small and medium sized formulators 
handle hundreds of products, each of which in turn are sold under 
multiple private labels. Thus a change in color requirements for 
labels generally will literally require a formulator to revise 
hundreds, if not thousands, of individual labels.
    Further, we believe the use of a black frame will not present a 
threat to worker health and safety. ISSA disagrees with OSHA's 
conclusion that a red frame would significantly enhance the 
communicative value of the label. In citing studies, OSHA does not 
take into account that the use of the new labels will be the subject 
of intensive employee training that will more than mitigate the use 
of a black frame over a red frame.

    In the NPRM regulatory analyses, OSHA did not assess the specific 
costs associated with red versus black borders, but has done so in the 
analyses for the final rule. See Section VI. As noted by proponents of 
the black border option for domestic shipments, the costs of a red 
border are greater. However, OSHA's analysis shows that they are 
economically feasible. In addition, OSHA believes that it is likely 
additional, cheaper printing options will be developed to comply with 
this requirement in the final rule. The EU requires red frames for 
pictograms: ``Hazard pictograms shall be in the shape of a square set 
at a point. They shall have a black symbol on a white background with a 
red frame sufficiently wide to be clearly visible.'' (http://europa.eu/legislation_summaries/internal_market/single_market_for_goods/chemical_products/ev0013_en.htm) Application of this requirement in 
the twenty-seven (27) EU member states is expected to lead to new 
printing options for compliance.
    OSHA believes that the increased comprehension that will be 
provided by the red border frame is compelling. The red color will 
clearly delineate the hazard symbols from the other information on the 
label, and the prominence will lead to increased attention and 
recognition of the hazards. The transport labels and placards that have 
been in use for many years have multiple colors in their pictograms, 
and yet compliance has been achieved. Plus most product labels have 
various colors related to their logos, brands, etc., so clearly it can 
be done.
    There are also some logistical issues that would make compliance 
more difficult with two different colored frames. First, it is unlikely 
that it would always be known whether a product would be exported at 
the point of labeling it at the end of the manufacturing process. Many 
containers are simply shipped to distributors, and the original 
manufacturer does not know where they will be sent after that--thus 
raising the question of whether a manufacturer or importer would know 
when to apply a black versus a red frame. In addition, workers exposed 
to chemicals purchased from different sources might have different 
frames, requiring additional training to avoid potential confusion. The 
final rule remains as proposed, and requires pictograms to have a red 
frame, with a black symbol on a white background, for all shipped 
chemicals regardless of destination.
    Several commenters (Document ID 0318, 0382, and 0393) also 
raised issues regarding whether pre-printed labels with blank red 
frames could be used. The manufacturer would simply add the symbols to 
the frames when printing the required label information. If a 
manufacturer or importer took this approach, a particular label might 
have one or more empty red diamonds in addition to any required 
pictograms. OSHA does not believe that this would be appropriate. Blank 
frames would still attract attention, but workers could be confused 
about what they mean and whether something is missing from the 
information. While blank frames could be marked to indicate they are 
intentionally left blank, they will still contribute to clutter on the 
label and distract from the primary messages (See, e.g., Document ID 
0284). Blank frames are not considered acceptable by DOT. (See 
49 CFR 172.401, Prohibited labeling; PHMSA Interpretation 02-0088). 
OSHA does not believe this is a good alternative for compliance either, 
and the final rule prohibits blank frames on the label (Appendix 
C.2.3.1).
    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 were 
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 employers 
and employees will already be familiar with them.
    The symbols in the proposed rule are adopted in the final rule. Dow 
Chemical (Document ID 0353) noted that the pictograms are not 
entirely self-evident. While this may be true, the rule requires 
training workers so they will know what the symbols mean and how to 
respond.
    It should be noted that in the NPRM, the pictogram for C.4.17 
(oxidizing gases) was published with a ``flame'' symbol, rather than 
the ``flame over circle'' symbol that was appropriate, and was 
described. OSHA has corrected this error in the final rule, and has 
inserted the appropriate ``flame over circle'' symbol in Appendix 
C.4.17 for oxidizing gases.
    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 final rule. 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 are not required under the current 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 UN Sub-
committee, are assigned to the appropriate hazard class and category, 
and have been translated into six languages. Work continues on them in 
the Sub-committee to combine or edit the precautionary statements to 
reduce repetition and the 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 decided 
to use those in the GHS as the mandatory

[[Page 17701]]

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.
    While the definition of precautionary statement itself did not seem 
to raise questions with rulemaking participants, there were a number of 
comments on the proposal to make the GHS precautionary statements 
mandatory. Many commenters agreed with OSHA that the statements should 
be on the label, and should be mandatory (Document ID 0328, 
0329, 0335, 0336, 0347, 0352, 0365, 0370, 0372, 0377, 0379, 0389, 0402, 
0408, 0410, 0412, and 0456). Commenters mentioned increased 
comprehensibility, as well as available translations, as some of the 
reasons why they support this approach. It was also noted by a number 
of commenters that OSHA should permit additional precautionary 
statements to cover situations without an available statement in 
Appendix C (Document ID 0313, 0324, 0327, 0329, 0335, 0352, 
0365, 0370, 0376, and 0402). Others supported making them mandatory 
when they are harmonized in the GHS (Document ID 0351 and 
0405). And at least one participant argued that precautionary 
statements should not appear on labels, just SDSs (Document ID 
0338).
    Other commenters did not support the mandatory approach, and 
thought that manufacturers should be able to continue to use their own 
precautionary statements (Document ID 0321, 0330, 0344, 0353, 
0363, 0376, 0381, 0382, 0393, and 0399). It was also suggested that the 
UN needs to provide further guidance on when precautionary statements 
can be combined or omitted (Document ID 0328, 0370, and 0376), 
or that the number of phrases appearing on a label should be limited 
(Document ID 0329 and 0405).
    In the final standard, OSHA has maintained the proposed provision 
to require the precautionary statements in the GHS to be used on 
labels. As noted previously, the use of prescribed precautionary 
statements is consistent with the other label elements, and provides 
the significant benefits of improved communication of information 
through increased comprehensibility and familiarity. In terms of 
flexibility, chemical manufacturers and importers are free to put 
additional precautionary statements on the label from other sources in 
the supplementary information area. As long as the information provided 
is accurate, and does not conflict with the required information, this 
is permitted.
    OSHA will also permit the statements to be combined as appropriate, 
and states in Appendix C.2.4.6: ``Precautionary statements may be 
combined or consolidated to save label space and improve readability. 
For example, ``Keep away from heat, sparks and open flame,'' ``Store in 
a well-ventilated place,'' and ``Keep cool'' can be combined to read 
``Keep away from heat, sparks and open flame and store in a cool, well-
ventilated place.''
    In addition, where there are concerns, supported by evidence, about 
the applicability of a statement to a particular product, the chemical 
manufacturer or importer may revise the statements as appropriate for 
the situation. Appendix C.2.4.8 states: ``If the chemical manufacturer, 
importer, or responsible party can demonstrate that a precautionary 
statement is inappropriate to a specific substance or mixture, the 
precautionary statement may be omitted from the label.''
    Thus, the final rule adopts the precautionary statements, which are 
taken from the GHS. However, it allows the use of additional statements 
where necessary, as long as they are accurate, do not conflict, and are 
placed in supplementary information. Additionally, chemical 
manufacturers and importers can use their judgment to combine related 
statements to shorten the amount of information on a label, as well as 
omit any statements that can be demonstrated to be inapplicable to the 
particular chemical involved. OSHA believes this approach maximizes the 
comprehensibility of the precautionary statements, as well as 
simplifies compliance for employers. Nevertheless, there are allowances 
for unique situations, and thus assurances that the information will be 
accurate.
    It was suggested that the precautionary statements should be 
written in plain language (Document ID 0321). There were some 
specific changes to particular statements that were suggested (such as 
a statement regarding fighting fires near explosives, Document ID 
0353). OSHA is not going to modify any of the statements as 
published in the GHS in terms of technical information. These have been 
reviewed by many experts. Changes should only be made to them through 
the UN Sub-committee process at this point, as they are close to being 
harmonized.
    However, OSHA has made a few minor changes to precautionary 
statements in this final rule to address clarity and related issues. 
These changes were adopted by the Sub-committee of Experts on the GHS 
at its December 2010 meeting, and are expected to be included in 
Revision 4 of the GHS. Most changes simply amend the precautionary 
statement to clarify its meaning by making the statement more concise, 
or stating it in plain language. Others either provide added 
flexibility in applying the precautionary statement, or provide 
instructions for the classifier on the conditions relating to use of 
the precautionary statement. Examples of each type are presented below.
    Examples of precautionary statements for physical hazards that were 
clarified in the final rule are presented below:

------------------------------------------------------------------------
                                             Precautionary statement in
 Precautionary statement in proposed rule            final rule
------------------------------------------------------------------------
Keep away from any possible contact with    Do not allow contact with
 water.                                      water.
In case of fire: Use * * * for extinction.  In case of fire: Use * * *
                                             to extinguish.
------------------------------------------------------------------------

    An example of a precautionary statement providing instructions for 
the classifier on the conditions relating to use of the precautionary 
statement is provided below for the health hazard class Skin corrosion/
irritation, Category 1A to 1C (for the illustration, the instructions 
for use are provided in italics). In this example, note that the 
precautionary statement was clarified and the conditions relating to 
use of the precautionary statement were added.

------------------------------------------------------------------------
                                             Precautionary statement in
 Precautionary statement in proposed rule            final rule
------------------------------------------------------------------------
Immediately call a poison center/or doctor/ Immediately call a poison
 physician.                                  center/doctor/ * * *
                                            Chemical manufacturer,
                                             importer, or distributor to
                                             specify the appropriate
                                             source of emergency medical
                                             advice.
------------------------------------------------------------------------

    The final example of the precautionary statement changes is 
provided below for instructions for the classifier on the conditions 
relating to use of the precautionary statement. In certain situations, 
text in a precautionary statement may not be appropriate. To address 
this issue, a new paragraph C.2.4.5 has been added to explain the use 
of text provided in square brackets ([ ]). Paragraph C.2.4.5 states: 
``Where square brackets ([ ]) appear around text in a precautionary

[[Page 17702]]

statement, this indicates that the text in square brackets is not 
appropriate in every case and should be used only in certain 
circumstances. In these cases, conditions for use explaining when the 
text should be used are provided. For example, one precautionary 
statement states: ``[In case of inadequate ventilation] wear 
respiratory protection.'' This statement is given with the condition 
for use: ``text in square brackets may be used if additional 
information is provided with the chemical at the point of use that 
explains what type of ventilation would be adequate for safe use.'' 
This means that, if additional information is provided with the 
chemical explaining what type of ventilation would be adequate for safe 
use, the text in square brackets should be used and the statement would 
read: ``In case of inadequate ventilation, wear respiratory 
protection.'' However, if the chemical is supplied without such 
ventilation information, the text in square brackets should not be 
used, and the precautionary statement should read: ``Wear respiratory 
protection.''
    OSHA has included these non-substantive, minor changes approved by 
the UN Sub-committee, because they make the statements more readable, 
allow added flexibility, and are consistent with the latest version of 
the GHS.
    Container labels will also be required to include a ``product 
identifier.'' The proposed definition for this term, which was retained 
in the final rule with a clarifying change (discussed below), was ``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'' (which has been deleted from the final 
rule) to maintain this approach. ACC (Document ID 0393) and 
Procter & Gamble (Document ID 0381) suggested that OSHA should 
clarify what the ``required list of hazardous chemicals'' refers to in 
the definition. This terminology has been in the HCS since the original 
standard was published in 1983, and refers to the only list of 
chemicals required by the HCS, which is in the written hazard 
communication program. Therefore, OSHA has modified the language in the 
final rule to read: ``among the list of hazardous chemicals required in 
the written hazard communication program, the label and the SDS.''
    Another new concept in the NPRM for HCS labels is inclusion of a 
``signal word'' to bring attention to the hazardous effects, as well as 
to contribute to the recognition of the severity of the hazard. Signal 
words have been used for many years in the United States on consumer 
and pesticide labels. The proposed definition is ``a word used to 
indicate the relative level of severity of hazard and alert the reader 
to a potential hazard on the label. The signal words used in this 
section are `danger' and `warning.' `Danger' is used for the more 
severe hazards, while `warning' is used for the less severe.'' OSHA 
received no objections to the proposed definition of ``signal word'' 
and it is being carried through to the final rule.
    OSHA proposed 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.
    OSHA proposed 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 the GHS criteria are 
sufficient to cover the hazards present in the workplace. While the 
Agency believed the scope of coverage is similar between the two 
approaches, OSHA wanted to be sure that the new approach is as 
comprehensive as the existing standard. In the NPRM (74 FR 50390, Sept. 
30, 2009), OSHA noted two hazards of concern--combustible dust and 
simple asphyxiants. Both of these are mentioned in the GHS in the SDS 
annex as examples of hazards not classified that should be addressed on 
the SDS.
    It is possible that there are other hazards that may not yet be 
specifically defined. Rulemaking participants have mentioned several 
(e.g., static accumulators) (Document ID 0382 and 0402). The 
addition of the definition for unclassified hazards was 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 captures those effects to ensure that the final 
rule 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. OSHA believed that addition of the 
proposed definition of ``unclassified hazards,'' and specific 
recognition of the need to provide information when such effects arise, 
would help U.S. industry address its product liability concerns as well 
as protect exposed workers (74 FR 50390, Sept. 30, 2009).
    OSHA proposed to require the chemicals posing unclassified hazards 
to be treated as hazardous chemicals under the rule. The Agency 
anticipated 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 proposed 
Appendix D included the requirement to list unclassified hazards. In 
terms of labeling, there are no specified label elements in the GHS for 
chemicals that pose unclassified hazards. OSHA proposed to require that 
the label for such hazards must name the chemical, and describe the 
hazardous effects

[[Page 17703]]

under supplementary information on the label, as well as provide any 
appropriate precautionary information. OSHA also expected that such 
hazards would be addressed in worker training programs.
    It is important to understand that the Agency anticipated that 
there would be relatively few situations where there would be 
scientific evidence or data indicating an effect that is not currently 
classified, and merely wanted to ensure that this information is 
captured and conveyed to employers and employees. OSHA also indicated 
that it would be appropriate to establish a feedback mechanism, where 
classifiers could inform OSHA of 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 proposed 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 was to be a temporary 
situation for these hazards, ensuring information is provided until 
such time as the criteria are added to the rule.
    There were many comments received regarding the NPRM definition and 
concept of ``unclassified hazards.'' A number of participants agreed 
with OSHA that there is a need to cover some hazardous effects that 
have not yet been spelled out in the GHS with criteria (Document ID 
0313, 0327, 0347, 0363, 0365, 0366, 0367, 0410, and 0412). 
Others suggested that it was an appropriate interim step, while working 
with the UN to get criteria added to the GHS (Document ID 
0329, 0330, 0335, 0339, 0352, 0370, 0376, 0383, 0405, and 
0414). Some argued that these hazardous effects should have specific 
criteria so employers would know with certainty what is covered 
(Document ID 0327, 0361, 0366, 0377, and 0392).
    With regard to the actual definition, some thought it was too broad 
and ambiguous (Document ID 0344, 0379, 0381, and 0399). The 
U.S. Chamber of Commerce (Document ID 0397) argued that the 
definition should be withdrawn, or substantially revised, and that OSHA 
was exceeding its authority. There were other commenters who thought 
the effects should be called ``hazards not otherwise classified'' or 
``additional hazards'' rather than ``unclassified hazards.'' See, e.g., 
Document ID 0328, 0344, 0363, 0370, 0376, 0393, and 0405. It 
was also suggested that the approach should only cover those hazards 
currently covered by the HCS (Document ID 0338).
    OSHA has considered all of these comments, and the need to provide 
sufficient protection for exposed employees, in devising an approach 
for the final rule. First, OSHA agrees with commenters that using the 
term ``hazards not otherwise classified'' is a better designation. 
Secondly, OSHA has revised the language to clarify the intent and 
address what was perceived as ambiguity. The definition in the final 
rule, which replaces and amends the proposed definition of 
``unclassified hazard,'' now reads: ```Hazard not otherwise classified 
(HNOC) means an adverse physical or health effect identified through 
evaluation of scientific evidence during the classification process 
that does not meet the specified criteria for the physical or health 
hazard classes addressed in this section. This does not extend coverage 
to adverse physical and health effects for which there is a hazard 
class addressed in this section, but the effect either falls below the 
cut-off value/concentration limit of the hazard class or is under a GHS 
hazard category that has not been adopted by OSHA (e.g., acute toxicity 
Category 5).''
    Additionally, and importantly, OSHA has deleted proposed paragraph 
(f)(2), which specified information to include on labels for the HNOC 
chemicals. Given that there are no harmonized label elements available 
for these effects, it appears that this could be confusing to both the 
label preparers and the users of the chemicals. However, provision of 
an SDS for HNOC chemicals is required under the final rule, and 
information regarding their hazards is to be included in Section 2.
    The U.S. Chamber of Commerce objected to the inclusion of 
``unclassified hazards'' in the final rule because, in its view, the 
proposed definition is ``broad,'' ``expansive,'' and will ``impose new 
requirements on employers without undertaking all of the steps in a 
full OSHA rulemaking'' (Document ID 0397). OSHA appreciates 
the concerns and has carefully considered (and in some respects 
revised) the provision with those concerns in mind. OSHA does not 
intend to impose new requirements, or to bypass rulemaking, but 
includes the definition to continue the longstanding requirements that 
such hazards be disclosed. As finalized and clarified, the relevant 
provision does not expand on those requirements or add new burdens; on 
the contrary, it preserves requirements in the current rule. The 
following discussion is designed to clarify these points.
    As noted above, the final rule retains the proposed requirement, 
using the term ``hazard not otherwise classified'' (HNOC) instead of 
unclassified hazard. In essence, this definition requires classifiers 
who find ``scientific evidence'' that a chemical can cause death, 
illness, or injury to workers in a way not currently covered by the GHS 
classification criteria to disclose that fact on the SDS. This is meant 
to be a modest and narrow requirement. It is triggered only when the 
classifier has objective, scientific evidence of the hazard. OSHA 
believes that there are likely to be few such hazards outside those 
covered by the specific criteria in the final rule, which are the 
product of over thirty years of international experience in hazard 
communication.
    It is important to understand that the HNOC definition essentially 
preserves (and does not expand) the scope of the current rule, which is 
not as tightly bound to specific criteria as the GHS. The HNOC 
definition should be interpreted and understood with this preservative 
goal in mind. For example, under the current rule, ``health hazard'' 
means a chemical for which there is at least one statistically 
significant scientific study showing that ``acute or chronic health 
effects may occur to exposed employees.'' Indeed, while mandatory 
Appendix A of the current standard lists criteria for specific health 
effects, it also notes that these criteria are not intended to be an 
exclusive categorization scheme, but rather any available scientific 
data on the chemical must be evaluated to determine whether the 
chemical presents a health hazard. Likewise, though the current 
definition of physical hazard is tied to a specific list of effects, 
some of these can also be quite broad. For example, under the current 
rule, ``flammable solid'' includes a material ``which can be ignited 
readily and when ignited burns so vigorously and persistently as to 
create serious hazard.''
    The essential point is that the HNOC definition is designed so as 
to prevent the final rule from being less protective than the current 
standard by picking up any hazards that might fall within the 
definitions of the current rule, but might fall outside the GHS hazard 
classes. As discussed above, it is OSHA's intent that the HNOC 
classification would be an interim measure, used until harmonized 
criteria for a hazard can be adopted at the UN Sub-committee level, and 
subsequently incorporated into the HCS through rulemaking.
    If the provision is understood in light of the foregoing points, 
this rulemaking is all the OSH Act and the Administrative Procedures 
Act (APA)

[[Page 17704]]

requires of OSHA before adopting the HNOC requirement. By preserving 
the requirements equivalent to those in the current rule, all the final 
rule does is to require chemical manufacturers and importers with 
reliable information that exposure to their chemical can cause illness, 
injury or death to an employee to disclose that fact on an SDS. OSHA 
has the authority to regulate hazard communication on a general level; 
indeed it must if it is to provide comprehensive worker protection in 
this area. See National Ass'n of Manuf. v. OSHA, 485 F.3d 1201, 1204 
(D.C. Cir. 2007); Associated Bldrs & Contrs. Inc. v. Brock, 862 F.2d 
63, 68 (3d Cir. 1988). Stakeholders have had a chance to comment on the 
HNOC requirement, and this rulemaking proceeding satisfies OSHA's 
statutory obligations.
    With regard to the three hazards specifically mentioned during the 
rulemaking (pyrophoric gases, simply asphyxiants, and combustible 
dust), OSHA is handling them as follows in the final rule.
    OSHA inadvertently removed the definition of pyrophoric gases from 
the proposal when it removed the generic definition for pyrophorics. 
The American Chemistry Council (ACC) correctly pointed out that 
excluding the pyrophoric gases, even though there is no corresponding 
definition in GHS, would mean that they would not be labeled or 
classified appropriately (Document ID 0393). OSHA agrees and 
has included the definition of pyrophoric gas in the current HCS in 
this final rule. Pyrophoric gases must therefore be addressed both on 
container labels and SDSs, and in worker training programs. Therefore, 
OSHA has retained the definition for pyrophoric gases from the current 
HCS and has added pyrophoric gases to the definition of ``hazardous 
chemical''. Label elements are provided in C.4.30. The signal word will 
be danger; the pictogram is the flame; and the hazard statement is 
``Catches fire spontaneously if exposed to air.''
    For the two examples of effects not addressed in the GHS that were 
raised in the proposal (simple asphyxiants and combustible dust), OSHA 
is addressing them specifically in the final rule rather than covering 
them under the HNOC definition. Using comments in the record, and 
commonly applied voluntary industry consensus standards, the Agency has 
designated chemicals with these properties under the definition of 
``hazardous chemical.'' The chemicals posing such effects must 
therefore be both labeled where appropriate, and addressed on SDSs and 
in training. In addition, OSHA has added C.4.30 to Appendix C to 
provide the label elements for OSHA defined hazards.
    With regard to simple asphyxiants, OSHA had indicated in Issue 
8 (74 FR 50282, Sept. 30, 2009) that it believed it might be 
more appropriate to simply add a definition of this effect to the final 
rule rather than covering it under the ``unclassified hazard'' 
approach. A definition was proposed 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 also solicited comments on proposed specific label elements. 
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.''
    A number of commenters agreed with the definition and the approach 
(Document ID 0339, 0347, 0351, 0365, 0366, 0370, 0405, 0408, 
and 0456). Others had specific comments on what was proposed, such as 
arguing for simplification of the language (Document ID 0414); 
proposing to replace the definition with the NFPA 704 definition of 
``simple asphyxiant'' (Document ID 0330); suggesting a 
reference to ``suffocation'' (Document ID 0329 and 0335), or 
indicating that the hazard statement is really a precautionary measure, 
or vice versa (Document ID 0376, 0382, 0393, and 0405). 
Procter & Gamble suggested it should not be covered since it is not an 
inherent toxicity (Document ID 0381).
    OSHA disagrees with Procter & Gamble's argument. Chemicals with 
certain properties can displace oxygen and cause asphyxiation. Not 
every chemical has those properties, so the asphyxiation hazard is 
inherent and chemical-dependent. Moreover, OSHA has provided 
longstanding interpretations that indicate simple asphyxiants are 
covered under the current HCS (e.g., OSHA interpretation, March 4, 
1993) and therefore industries working with these substances have 
provided labels and SDSs on simple asphyxiants in accordance with HCS 
requirements.
    OSHA believes that coverage of simple asphyxiants is very important 
to the HCS. Such substances result in fatalities in the workplace, 
particularly in confined spaces, and need to be warned about 
effectively. The definition has been revised based on the comments 
received, and included in paragraph (c): `` `Simple asphyxiant means a 
substance or mixture that displaces oxygen in the ambient atmosphere, 
and can thus cause oxygen deprivation in those who are exposed, leading 
to unconsciousness and death.'' Label elements are provided for simple 
asphyxiants in Appendix C.4.30. Simple asphyxiants will require the 
signal word ``warning'' and the hazard statement ``may displace oxygen 
and cause rapid suffocation.'' In addition, OSHA has added ``simple 
asphyxiant'' to the definition of ``hazardous chemical.'' Thus all of 
the provisions of the rule that apply to hazardous chemicals will apply 
to simple asphyxiants as well.
    OSHA will continue to work with the UN to add this hazard to the 
GHS. (The U.S. has raised this issue in the UN Sub-committee, but it 
has not yet been resolved. Some of the Sub-committee members share the 
view that it should not be covered since, according to them, it is not 
an inherent hazard.) We will evaluate the need for additional 
rulemaking to change the definition and label elements if the UN 
incorporates simple asphyxiants into the GHS.
    For combustible dust, OSHA has also already provided considerable 
guidance on the nature and definition of combustible dust in a variety 
of materials, including OSHA's Hazard Communication Guidance for 
Combustible Dusts, OSHA (3371-08 2009), and its Combustible Dust 
National Emphasis Program Directive CPL 03-00-008. As described in the 
preamble to the NPRM (74 FR 50395, Sept. 30, 2009), this was an issue 
that many ANPR commenters had provided information on, and is clearly a 
concern in the workplace. There have been a number of workplace 
incidents involving combustible dust, and the U.S. Chemical Safety and 
Health Investigation Board highlighted the need to address this 
specifically in the HCS (Document ID 0110):

    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.


[[Page 17705]]


    OSHA has introduced this issue to the UN Sub-committee as well, and 
is leading a correspondence group on it. However, one of the problems 
in pursuing this approach is that some countries' systems are limited 
to supply chain requirements, and do not cover hazard communication 
issues that arise in the workplace as a result of processing. OSHA's 
rule does cover such workplace hazards, and requires the provision of 
information to downstream customers when known processing approaches 
will result in a hazard. Therefore, discussions continue, but the Sub-
committee will not resolve this for at least two years.
    In light of the important nature of the issue, a number of public 
comments, and the need to provide clarity sooner than the UN Sub-
committee will complete its work, OSHA is including combustible dust in 
the definition of ``hazardous chemical'' in this final rule. We have 
noted that many commenters agreed that there was a need to provide 
hazard communication on combustible dust, as has been required by OSHA 
under the current rule. But there were also suggestions that criteria 
and greater clarity were needed in order to avoid confusion. A few 
commenters argued that OSHA should not cover combustible dust since it 
is not an intrinsic hazard of a product (See, e.g., Document 
ID0393). However, OSHA believes that similar to the situation 
with simple asphyxiants, all dusts in the workplace are not 
combustible, and processing of them does not always result in 
combustible atmospheres. Consistent with Executive Order 13563 and its 
emphasis on reducing uncertainty, OSHA agrees with commenters noted 
above that employers need certainty to properly cover it.
    It is true that a separate rulemaking is ongoing on this topic in 
OSHA, and some commenters suggested that the combustible dust issue 
should therefore not be addressed in this rulemaking. Such an approach 
would, however, eliminate safeguards that have long been in place 
(since 1983). Similar to the situation with simple asphyxiants, OSHA 
has provided longstanding interpretations that indicate combustible 
dusts are covered under the current HCS (e.g., OSHA interpretation, 
January 16, 1986). Specifically, under OSHA's existing Hazard 
Communication Standard, combustible dust is addressed under the broad 
definition as both a flammable solid and an explosive hazard. 
Therefore, not addressing combustible dust in this rulemaking would 
fail to meet the requirements--which are central to the existing 
standard--that chemical manufacturers and importers provide information 
on hazardous chemicals.
    While OSHA is currently in the preliminary stages of developing a 
proposed rule to address combustible dust, the new standard is not 
expected to be completed for some time. It is also important to note 
that there is a clear distinction between coverage under the HCS, and 
potential provisions promulgated under a specific rulemaking for 
combustible dust. The rulemaking on combustible dust is a much broader 
approach to the issue, and will likely establish methods to control and 
address such dusts in the workplace. The HCS is an information 
transmittal standard. Provision of information to downstream employers 
is critical now, as it can alert them to the need to have a protective 
program. This is a fundamental purpose of the HCS--to provide employers 
and employees with information about hazards so they can take steps to 
protect their employees and themselves. A failure to continue to 
address the combustible dust issue in the HCS at this time would 
eliminate current protections. Therefore, the Agency is clarifying its 
position that it will continue to regard combustible dust as a serious 
hazard for which chemical manufacturers and importers must provide 
information to downstream employers.
    The Agency is not adding a definition for combustible dust to the 
final rule given ongoing activities in the specific rulemaking, as well 
as in the UN Sub-committee. However, guidance is being provided through 
existing documents, including the Combustible Dust National Emphasis 
Program Directive CPL 03-00-008. This directive includes an operative 
definition, as well as provides information about current 
responsibilities in this area. In addition, there are a number of 
voluntary industry consensus standards (particularly those of the NFPA) 
that address combustible dust, and were noted by commenters as 
providing further guidance in this area. (See, e.g., Document ID 
0379 and 0530). Chemical manufacturers and importers must be 
aware of the hazards of their products, both in the shipped form, and 
under normal conditions of use or foreseeable emergencies in downstream 
workplaces, in order to comply with the HCS. Information about these 
hazards is required to be transmitted through labels and SDSs as 
specified in the standard. The protection of workers in downstream 
workplaces depends on the provision of accurate information to their 
employers.
    Label elements are also provided for combustible dust in C.4.30 
requiring, when appropriate, the signal word ``warning'' and the hazard 
statement ``May form combustible dust concentrations in air'' (similar 
to ANSI Z400.1/Z129.1--2010 statements).
    Concerns were raised by commenters that labels with a signal word 
and hazard statement may not be appropriate in some situations, because 
the combustible dust is created through processing downstream, and the 
product may not present a hazard in its shipped form. (See, e.g., 
Document ID 0050 and 0353.) Dow (Document ID 0353) 
pointed out: ``Over-warning would dilute the message.''
    OSHA has already addressed a similar situation under paragraph 
(f)(4) of the final standard, which addresses solid metal, solid wood, 
plastic, and shipments of whole grain that present no hazard in 
shipping, but which are used in such a way in downstream operations 
that employees can be exposed to hazards. In this situation, the 
downstream employer needs label information about the hazards to 
protect employees, but OSHA determined that such label information does 
not need to accompany the product. Therefore, paragraph (f)(4) allows 
the chemical manufacturer or importer to transmit the label to the 
customer at the time of the initial shipment, but the label does not 
need to be included with subsequent shipments unless it changes. This 
provides the needed information to the downstream users on the 
potential hazards in the workplace, while acknowledging that the solid 
metal or other materials do not present the same hazards that are 
produced when these materials are processed under normal conditions of 
use.
    Many products that are a combustible dust hazard when processed are 
similar in nature, and therefore paragraph (f)(4) would apply. A 
shipment of grain, for example, does not present a combustible dust 
hazard in the shipped form. But when processed downstream in a plant, 
such hazards are a concern, and the employer needs the label 
information to properly address the hazard in the workplace. Since this 
is a normal condition of use for the grain, the chemical manufacturer 
or importer must provide the information at the time of the initial 
shipment, and in the future if there is new information regarding the 
hazards or protective measures. An SDS must always be provided.
    In other situations where the material is shipped in a dust form 
that is potentially combustible without further processing, the 
chemical manufacturer or importer must have appropriate labels on the 
containers when shipped under the requirements of paragraph (f)(1). If 
the chemical manufacturer

[[Page 17706]]

labels the product for combustible dust, the label must use the 
required labeling elements in C.4.30.
    Combustible dust has been added to the definition for hazardous 
chemical, and thus all of the provisions of the standard as amended by 
the final rule that apply to hazardous chemicals will also apply to 
combustible dusts, including safety data sheets and worker training. 
Employers with workplaces where combustible dusts are generated must 
comply with the workplace labeling requirements in paragraph (f)(6).
    As with simple asphyxiants, OSHA will continue to encourage the UN 
Sub-committee to deal with combustible dusts and develop criteria to be 
adopted by countries such as ours where workplace exposures are a key 
part of the hazard communication system.

(d) Hazard Classification

    Hazard determination under the current standard. Under the current 
HCS, chemical manufacturers and importers are required to evaluate the 
scientific data available regarding each chemical they produce or 
import, and determine whether the chemical is 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 
approach 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 current 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 current 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 current 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 1910.1200 (f)(1)(ii). Thus, there is 
consideration of the weight of evidence when deciding what to include 
on a label. Chemical manufacturers and importers may also review the 
weight of evidence in preparing SDSs, and are permitted to discuss 
negative evidence and other constraints when reporting the information. 
Under the current standard, OSHA expects the hazard evaluation process 
to go beyond simply identifying one study, and include 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[supreg] 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 current 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. The stay does 
not apply to safety data sheets. OSHA proposed to reinstate the 
requirement and lift the stay, making the updating period consistent 
with that required for safety data sheets (See the discussion below on 
labels).
    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 biennial Report on Carcinogens (RoC), 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 current 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 are 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 (by weight or 
volume) or more of a chemical determined to present a health hazard, 
the mixture is assumed to have the same effect. The one exception is

[[Page 17707]]

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 current 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 current HCS does not require testing of chemicals to 
produce information where it is not available.
    The hazard determination approach in the current 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 current 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 current HCS, including 
the definitions and Appendixes A and B, have been in place since the 
standard was promulgated in 1983.
    Hazard classification under the GHS. The challenge in negotiating 
an international approach was to create a system that did not require 
frequent changes yet remained current and protective, incorporating the 
best parts of the approaches in the existing systems. The GHS embodies 
an approach that is very similar to the current 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., the final rule modifies the 
current HCS as follows. First, paragraph (d) is re-named ``hazard 
classification'' rather than the current ``hazard determination.'' This 
re-naming is consistent with the approach and terminology used in the 
GHS.
    Similarly, final paragraph (d)(1), like the proposal, modifies the 
current HCS to indicate that chemical manufacturers and importers are 
required to classify the chemicals' health and physical hazards in 
accordance with this section. 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.
    Final paragraph (d)(1) allows employers to rely on information 
received from suppliers (i.e., chemical manufacturers or importers). In 
the final rule, OSHA made two minor changes to the proposed text. 
Instead of saying that chemical manufacturers would be required to 
classify ``their'' physical and health hazards, OSHA has replaced 
``their'' with ``the chemicals'' for clarification purposes. In 
addition, OSHA has added the phrase ``where appropriate'' to add 
clarity that not all hazard classes have more than one category. The 
final paragraph (d)(1) now reads as set forth in the regulatory text of 
this final rule.
    Final paragraph (d)(2), which is identical to the proposal, 
similarly modifies the current HCS's terminology regarding 
classification. However, the final 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, final 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. Dow Chemical Company (Document ID 0353) suggested 
that OSHA revert to the current text of paragraph (d)(2), which simply 
referred to Appendix B for the parameters of the hazard determination. 
This would not be appropriate since Appendix B no longer exists in its 
current form. But OSHA does not believe that what is written in 
paragraph (d)(2) is inconsistent with what is currently required in 
Appendix B. It is not intended to mean (and does not say) that an 
evaluator must identify every ``shred'' of information as Dow has 
indicated in its comment, but rather that the evaluator cannot, for 
example, only review acute toxicity data and consider that a complete 
evaluation. The extent of the literature search must be what the 
reasonably prudent classifier would do to assure themselves that 
evidence for the range of hazards covered by the rule has been 
identified, and a thorough evaluation has been done of the potential 
effects. That is

[[Page 17708]]

what is required today under the current HCS.
    On the other hand, the Styrene Information and Research Center 
(SIRC) (Document ID 0361) commented on the same paragraph as 
follows:

    SIRC supports hazard classification for carcinogenicity and 
other endpoints based on a comprehensive assessment of the ``full 
range of available scientific literature and other evidence 
concerning the potential hazards,'' within a best available science 
framework. This approach should provide optimum precision assessing 
potential hazards and a sound basis for maintaining a safe and 
healthy workplace.

    Final paragraph (d)(2) refers to Appendixes A and B for further 
information on classification as in the current standard. However, the 
Appendixes have been completely changed from the current text. New 
Appendix A includes the criteria for classification of health hazards, 
and new Appendix B includes the criteria for classification of physical 
hazards. These mandatory appendixes have to be used for the hazard 
classification process under the revised standard. The Appendixes have 
been adopted in the final rule, with some changes as described below.
    Reference to these appendixes is also included in final paragraph 
(d)(3), which addresses mixtures. Final paragraph (d)(3)(i), like the 
proposal, states 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. Proposed paragraph (d)(3)(ii) 
stated that the chemical manufacturer or importer ``shall be 
responsible for the accuracy of the classification even when relying on 
the classifications for individual ingredients received from the 
ingredient manufacturers or importers on the safety data sheets.'' SIRC 
expressed reservations about this proposed paragraph (Document ID 
0494 Tr. 128-29; See also Document ID 0361). In 
commenting on this provision, SIRC said it was uncertain whether this 
provision meant that a classifier could rely on the classifications 
found in SDSs from the ingredient supplier, or whether the classifier 
was required to ensure that the supplier's classification was correct. 
It was OSHA's intent in the proposal to clarify that generally 
classifiers may rely on the classifications found on the SDSs received 
from suppliers. The final rule revises (d)(3)(ii) to state that when 
chemical manufacturers and importers are classifying mixtures, they may 
rely on the information provided on current safety data sheets of the 
individual ingredients, except where the chemical manufacturer or 
importer knows, or in the exercise of reasonable diligence should know, 
that the safety data sheet misstates or omits required information.
    In reconsidering the language proposed, OSHA wanted to ensure that 
chemical manufacturers and importers know that, in most cases, they can 
continue to rely on their suppliers' SDS information for ingredients 
they will be using in formulations. However, where they know 
information is incomplete or wrong, they have some responsibility for 
ensuring they have the correct information before using it for their 
own evaluations.
    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 of providing the SDSs for all the 
ingredients is widely pursued, but it will not be permitted under the 
final rule. The revisions to the approach to classifying mixtures do 
not lend themselves 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 final 
rule because the hazard classification procedures have been specified, 
and thus all evaluators are following the same process.
    Final 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 substance 
and that substance 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 revisions only apply to 
chemical manufacturers and importers, unless an employer chooses not to 
rely on information received from them.
    The GHS criteria. A number of commenters expressed their general 
support for the GHS criteria, and agreed that the criteria will result 
in thorough, harmonized hazard evaluations (See, e.g., Document ID 
0329, 0330, 0335, 0339, 0370, 0375, and 0389). In adopting the 
GHS approach, the final rule deletes from the hazard classification 
requirements the ``floor'' of hazardous chemicals described above--
established lists of chemicals that are considered hazardous under the 
HCS in all situations. In addition, OSHA deleted the across-the-board 
``one study'' rule described above, wherein one good scientific study 
established that a substance is a hazard. However, the one-study 
approach is still included in some of the criteria in the GHS, and thus 
in the revised OSHA rule.
    With the detailed criteria, and the weight of evidence approach in 
the GHS, OSHA indicated in the NPRM that it appeared to no longer be 
necessary to have such a floor or the one study rule. Many commenters 
agreed with OSHA (See, e.g., Document ID 0313, 0327, 0328, 
0336, 0338, 0339, 0344, 0351, 0361, 0363, 0365, 0367, 0370, 0371, 0375, 
0376, 0377, 0379, 0381, 0382, 0383, 0393, 0399, 0405, 0408, and 0410). 
For example, the Alliance of Hazardous Materials Professionals 
(Document ID 0327) indicated:

    Elimination of the ``floor'' definition of hazardous (as 
consistent with the GHS) would require producers and users to more 
closely examine the properties of the materials they produce or 
handle. While this would increase the effort necessary to determine 
that some substances are hazardous, it would also force a more 
careful examination of the underlying reasons that the substance is 
hazardous.

    There were few comments that questioned taking the floor out of the 
requirements given the detailed nature of the criteria to evaluate 
hazards. It was noted that the lack of a floor may result in some 
inconsistencies in evaluations (Document ID 0352). There were 
also some concerns about removing IARC and NTP as sources to evaluate 
chemicals (Document ID 0321). Conversely, others supported 
elimination of these resources because inclusion violated the Data 
Quality Act (Document ID 0417)--a conclusion that OSHA does 
not believe is accurate. Evaluation of carcinogens will be

[[Page 17709]]

addressed further below. OSHA has not included a ``floor'' of hazardous 
chemicals in the final standard.
    As OSHA indicated in the proposed rule (74 FR 50282, Sept. 30, 
2009), the Agency planned to adopt all of the health and physical 
hazard classes in the GHS, but not all of the hazard categories. In 
keeping with its intent to maintain the scope of coverage of the 
existing rule to the extent possible, as well as to be as consistent as 
possible with the scope of the European implementation of the GHS, OSHA 
did not propose to adopt Acute Toxicity, Category 5; Skin Corrosion/
Irritation, Category 3; and Aspiration Hazard, Category 2.
    Many commenters agreed that the categories selected in the proposal 
were appropriate (See, e.g., Document ID 0313, 0327, 0329, 
0330, 0338, 0344, 0351, 0353, 0365, 0367, 0370, 0376, 0377, 0379, 0381, 
0382, 0383, 0393, 0399, 0402, 0408, and 0410), although there were some 
who thought all hazard categories should be adopted to be completely 
consistent with the GHS (See, e.g., Document ID 0328, 0335, 
0336, and 0339). There were other comments that supported streamlining 
the document by omitting the guidance portions of the GHS (Document ID 
0328, 0399, and 0408); stated that the goal should be 
harmonization with trading partners, so if they exclude categories, 
OSHA should exclude them too (Document ID 0335 and 0389); or 
indicated that OSHA should accept labels and SDSs that include the 
excluded hazard categories (Document ID 0328, 0379, and 0405). 
OSHA indicated in the NPRM (74 FR 50383, Sept. 30, 2009) that 
additional information could be included on labels and SDSs in any 
event, and that is the position in the final rule as well. (See (g)(2); 
Appendix C.3.)
    While the decision logics for the health and physical hazard 
criteria were omitted from the regulatory text, OSHA indicated that it 
would consider publishing them as guidance. Commenters agreed with this 
concept (See, e.g., Document ID 0344, 0351, 0370, 0381, 0410, 
and 0453). It was further suggested that the diagrams be made simple so 
all workers can understand them (Document ID 0336). The 
decision logics are already part of the GHS, and are graphic 
representations of the process of determining each type of hazard. As 
such, they are tools for preparers of labels and SDSs, rather than for 
exposed workers. Another comment was that public comment should be 
sought on the decision logics before publishing them (Document ID 
0379). Given that they are already part of the agreed text of 
the GHS, and are guidance, OSHA will make them readily available on the 
Agency's Web page.
    There were also comments that OSHA should publish guidance on its 
interpretation of criteria application, and indicate whether it agrees 
or disagrees with interpretations published by other countries 
(Document ID 0382). OSHA is considering many different types 
of guidance documents, but has not made final decisions in this regard.
Background on Appendices A and B
    The text of Appendixes A and B is the bulk of what was proposed to 
be adopted essentially verbatim from the GHS. While some of the 
provisions of the GHS have been adopted into the final rule with OSHA-
developed language that is specific to the regulatory system of the 
U.S., OSHA has strived in these appendixes to retain the text of the 
GHS intact. In order to understand the context of this language, and 
OSHA's approach to its inclusion, a brief history of its development is 
necessary.
    Most people think of the labels and SDSs as the products of the GHS 
that are harmonized since they are the system's ``output'' that are 
seen most frequently. But harmonization of these documents cannot occur 
unless the underlying criteria are harmonized, and countries adopting 
them implement them similarly. The health hazard criteria were 
developed in the Organization for Economic Cooperation and Development 
(OECD)--an organization of 34 countries that ``provides a forum in 
which governments can work together to share experiences and seek 
solutions to common problems.'' See www.oecd.org. One of the areas in 
which the OECD has long been actively involved is chemicals. As such, 
the OECD provides a forum for countries' experts to discuss and resolve 
issues of mutual concern. In addition, the OECD works with business, 
through the Business and Industry Advisory Committee, and with labor, 
through the Trade Union Advisory Committee. Perhaps its most visible 
contribution in the area of chemicals is test guidelines to assess the 
hazards of chemicals. These test guidelines address many different 
health effects; are considered to be scientifically robust, validated 
test methods; and are widely used around the world.
    It was this expertise and recognition that led to the OECD being 
the ``focal point'' for development of the health hazard criteria. The 
OECD also uses a process of consensus to develop their documents, 
requiring agreement from all countries to move forward rather than a 
simple majority vote. Working on a consensus basis is much more 
difficult to accomplish, but is advantageous in other ways since it 
helps to ensure that the concerns of all parties are taken into 
consideration, and thus are more likely to remain consistent with the 
results.
    A disadvantage is that the text must satisfy all parties, and thus 
it is not always written in the clearest fashion. The text was also 
reviewed further when it was submitted to the UN Sub-committee, and 
additional editing was done to address concerns. Therefore, it is fair 
to say that it was written by expert committees, and reflects the 
involvement of many different people and ideas.
    The criteria in Appendix B, unlike those in Appendix A, were not 
developed ``from scratch,'' but were based on the harmonized criteria 
developed to classify the physical hazards of chemicals involved in 
transport by the UN Sub-committee of Experts on the Transport of 
Dangerous Goods (TDG). The TDG Sub-committee includes many subject 
experts in areas such as explosives and flammability. The TDG Sub-
committee and the International Labor Organization (ILO) were jointly 
tasked to review the TDG criteria for application to other sectors such 
as the workplace. This review not only took advantage of the UN and ILO 
expertise, but also created a system that is harmonized with transport 
in terms of criteria.
    When OSHA developed the proposed rule, it considered editing the 
text of the criteria for purposes of improving the language. However, 
the trade-off is inconsistency with the GHS, and the potential for 
people to believe that OSHA means something different because the text 
has been revised. Thus, as noted in the NPRM (74 FR 50392, Sept. 30, 
2009), OSHA chose to take the approach of adopting the language as 
stated in the GHS. Editing of the criteria focused on what needed to be 
changed for purposes of putting it into mandatory regulatory language, 
including deleting what was clearly identified as guidance.
    Therefore, while we have reviewed every suggestion that was made to 
the text of the Appendixes, our general approach was not to make 
changes unless they were truly necessary. Editorial changes for 
purposes of clarification are more appropriately made through the UN 
Sub-committee process, and OSHA participates actively in that activity, 
and chairs the primary correspondence group. Those changes that were 
suggested that OSHA believes have merit in terms of clarifying

[[Page 17710]]

provisions will be worked through this correspondence group so the UN 
Sub-committee can make the changes. Then OSHA will adopt them into the 
revised standard through rulemaking processes discussed elsewhere in 
this preamble. To avoid giving this same response repeatedly, OSHA will 
not be individually addressing the many suggestions for clarifications 
in this preamble.
    In general, there were very few substantive technical comments 
provided on the approaches in the criteria, and OSHA assumes that 
reflects the fact that the criteria were developed by technical experts 
from countries and stakeholder organizations. There were some 
suggestions received that certain parts of Appendix A be withdrawn so 
OSHA can consult with toxicologists (Document ID 0353). 
Numerous toxicologists and other health professionals from the U.S., as 
well as many other countries, have been involved in the development and 
review of the text in Appendix A, and it has been subject to extensive 
scientific and policy discourse. Furthermore, this rulemaking was also 
the opportunity for others who have not been involved to provide input. 
If OSHA had received significant comments on the technical aspects of 
the criteria that indicated a systemic concern about the criteria, it 
may have been cause for reconsideration. But most of the comments that 
were received were more reflective of differences on policy positions 
than truly technical issues. Therefore, there are relatively few 
changes to Appendixes A and B as a result of record input. These 
changes are discussed below.
    As described in the NPRM and this document, in Appendixes A and B 
OSHA has maintained its general approach (supported by stakeholders) 
of: (a) Limiting changes to the HCS to those that are required to align 
with the GHS; and (b) remaining as consistent with the GHS as possible 
within the need to use appropriate regulatory language and maintain or 
enhance current protections. OSHA has also remained mindful of the 
approaches of its trading partners, although it notes that some 
proponents of that principle were quite inconsistent themselves when 
using this particular argument. Therefore, while this argument was used 
to support choosing higher cut-offs for mixtures, for example, some of 
these same commenters also suggested not covering hazard classes or 
categories that are both covered by the EU and currently addressed by 
OSHA (See, e.g., Document ID 0344, 0381, and 0393). These 
comments are addressed below.
    Appendix A, Health Hazards. Proposed Appendix A began 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. In A.0.3.2, the 
proposed text referred to both positive and negative results being 
``assembled together.'' Dow (Document ID 0353) expressed 
concern about the implications of the word ``assembled.'' In the final 
rule, OSHA has revised this language throughout the chapter to say 
``shall be considered together.'' Dow also commented that in the 
discussion regarding acceptable data in A.0.2.2 and A.0.2.3, the text 
should refer to ``valid'' methods, rather than ``validated.'' OSHA does 
not agree that this change is warranted. To be ``valid'' data, the 
methods used to produce the data must be validated. In order to clarify 
the discussion, OSHA has revised the text by adding two sentences from 
the GHS to A.0.2.3 as follows:

    Any test that determines hazardous properties, which is 
conducted according to recognized scientific principles, can be used 
for purposes of a hazard determination for health hazards. Test 
conditions need to be standardized so that the results are 
reproducible with a given substance, and the standardized test 
yields `valid' data for defining the hazard class of concern.

    As mentioned below in the discussion on mixtures, OSHA has also 
revised Appendix A to use ``cut-offs/concentration limits'' everywhere 
one of these terms was formerly used in order to be consistent, and 
make clear the terms are interchangeable.
    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. OSHA removed the decision logics that are in 
the GHS from the criteria, and is considering including them in a 
guidance document to be made available at the time the final rule is 
published. As discussed above, stakeholders generally supported this 
approach. The hazard communication portions of the criteria chapters 
have also been removed since all of this information is already 
available in Appendix C and would thus be duplicative. In addition, 
edits have been made where OSHA is not adopting all of the categories 
of a particular hazard class.
    The chapters on Skin Corrosion/Irritation (Chapter A.2) and Serious 
Eye Damage/Irritation (Chapter A.3) have been modified more extensively 
than the other chapters on health hazards in the GHS. In these 
chapters, the GHS leads the evaluator to conduct additional testing on 
the chemical when information is not available. While the GHS does not 
require such testing, the criteria for these effects imply that it 
should be conducted to complete an evaluation. The HCS is based solely 
on available information, and no testing is ever required. Therefore, 
OSHA has modified these chapters to eliminate any references to 
additional testing and limit the evaluation to what is known based on 
available information. It should be noted that the UNSCEGHS has 
initiated work to edit these chapters and make them easier to follow. 
OSHA will continue to participate in this activity.
Coverage of Mixtures
    The coverage of mixtures in terms of health hazards is addressed in 
two places in the revised rule. First, general principles that apply to 
multiple effects are addressed in the introductory part of Appendix A 
in Chapter A.0, ``General Classification Considerations.'' Second, each 
hazard class discussion includes the criteria for classifying a 
substance or a mixture. Unlike the current HCS, which defines across-
the-board percentage cut-offs for all health 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-offs/concentration limits 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 approach is related to the sensitivity of 
available test methods to detect these types of effects at small

[[Page 17711]]

concentrations in the mixture as a whole.
    The approach to mixture classification 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 comprised of 1% of an acutely toxic material, 
regardless of the severity of that effect, and 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.
    The GHS uses both the term ``cut-off'' (which is what is used in 
the current HCS), and ``concentration limit'' (which is used in the EU 
requirements). The terms are used interchangeably and often appear 
together (i.e., cut-offs/concentration limits). Several commenters 
indicated that OSHA should define these terms (Document ID 
0344, 0381, and 0393). There are no definitions in the GHS 
since the terms are self-evident when viewed in the context of how they 
are used. OSHA does not believe that definitions are needed for these 
terms. However, Appendix A has been reviewed to make sure the terms are 
both used consistently throughout the Appendix. The GHS was also 
reviewed, and it appears the terms are not necessarily used 
consistently in that text.
    Several commenters indicated that language in A.0.5.1.1(a), in the 
bridging principle that addresses dilution, was inappropriately changed 
from ``may'' to ``shall'' in the NPRM (See, e.g., Document ID 
0344, 0381, 0382, and 0393). OSHA changed the language to 
track the mandatory nature of the provision when present in a standard 
versus a non-mandatory recommendation such as the GHS. Therefore, the 
language remains as ``shall'' in the final rule.
    In another part of the bridging principles, the term ``commercial 
product'' is used in the GHS, and was thus used by OSHA in the NPRM 
(A.0.5.1.2). Commenters asked that this term be defined (Document ID 
0344 and 0381). OSHA reviewed the text, and has changed the 
term to ``mixture'' instead of ``commercial product''. This is 
accurate, and the term is already defined.
    There are several hazard classes in the GHS that give competent 
authorities such as OSHA a choice of cut-offs/concentration limits to 
apply when classifying a mixture containing ingredients that pose these 
effects (e.g., reproductive toxicity, sensitization, target organ 
effects). The reason the GHS includes a choice of cut-offs to trigger 
label disclosure is that countries involved in the negotiations on 
mixtures had different views on the issue that could not be resolved. 
All countries agreed to use the lower of the two cut-offs for SDSs, so 
information will be provided consistently for those documents in all 
cases. But for labels, some countries had what were described as 
``downstream consequences'' that were linked to label disclosures, and 
therefore did not want to adopt the lower level and trigger those 
consequences (e.g., banning the use of the chemical for consumer 
products).
    In North America, Canada and the U.S. do not have such consequences 
linked to label statements, and their requirements are based on giving 
workers the right-to-know about the hazards and identities of the 
chemicals in their workplaces. Additionally, Canada has the lower cut-
offs in most cases in their current requirements, and OSHA already has 
the 0.1% cut-off for carcinogenicity. Adoption of the lower cut-offs 
for both labels and SDSs was supported by both Canada and the U.S. from 
the outset.
    As has been described, OSHA has used consistent cut-offs for 
purposes of hazard determination for mixtures since the HCS was 
promulgated in 1983. OSHA described the proposal as follows in the 1983 
final rule preamble (48 FR 53290, Nov. 25, 1983):

    The rationale of the proposal was that when the hazard of a 
mixture is unknown, all hazardous ingredients should be indicated on 
the material safety data sheet. The user would then have the most 
complete information available to predict the potential hazards of 
the mixture. The one percent exclusion was included to absolve the 
employer from having to evaluate and list chemicals in small 
quantities, which are not likely to result in substantial exposures.

    In the 1982 proposal, the one percent cut-off would have applied to 
all health and physical hazards. As a result of the comments submitted 
to the record, OSHA took a different approach to physical hazards in 
the final rule (no percentage cut-off applies to physical hazards), and 
also lowered the cut-off for carcinogenicity to 0.1 percent. In 
addition, a provision that required inclusion of chemicals below these 
cut-offs in certain situations was also part of the 1983 final rule.
    In proposing the one percent cut-off, OSHA noted that ``there was 
no scientifically correct delineation, but that the one percent cut-off 
is apparently considered reasonable by a number of parties'' (47 FR 
12102, Mar. 19, 1982). OSHA's intent was ``to absolve the employer from 
having to evaluate and list chemicals present in mixtures in small 
quantities, which are not likely to result in substantial exposures'' 
(48 FR 53290, Nov. 25, 1983). These cut-offs were practical 
accommodations, had been used in other regulatory settings (See, e.g., 
29 CFR 1910.1003(a)(2), 13 Carcinogens), and in the 1983 final rule 
were accompanied by a provision that also covered those situations 
where the cut-offs were too high for protection purposes. Science 
regarding potential health hazards in the workplace does not provide 
evidence that would allow the Agency to draw a bright line to indicate 
specific concentrations of a chemical in a mixture are, or are not, a 
potential hazard to workers. Therefore, the establishment of such cut-
off levels is a policy decision based on scientific considerations, as 
well as concerns regarding practicality and utility, but not on studies 
that can be linked to a particular level for each type of health 
effect.
    That being said, however, the scientific knowledge about these 
health effects has increased significantly since the HCS was first 
adopted, as has the concern about their occurrence in the work force. 
At that time, carcinogenicity was the primary concern in terms of 
chronic and/or significant health effects, and this concern was 
reflected in the lower cut-off value adopted by OSHA for that effect. 
Most of OSHA's substance-specific rulemakings were done for the purpose 
of addressing carcinogenicity. Now, however, there is more evidence 
that raises significant concerns about other types of effects.
    Sensitization is a key example. Respiratory sensitization leads to 
asthma, and substantial evidence has

[[Page 17712]]

developed over the last few decades showing this effect is of 
increasing concern. For example, a study by Frazier et al. (2001, 
Document ID 0587) notes that the incidence of occupational 
asthma has increased by 50% over the last two decades, and that 
population-based surveys have reported that 5% to 21% of asthma cases 
are caused or exacerbated by occupational exposure. The authors 
extrapolated this to the estimated 12 million adults who have asthma in 
the U.S., and concluded that this suggested that between 500,000 and 
2.5 million Americans had occupational asthma. This study was published 
in 2001, and the numbers are likely to be larger today. The study also 
examined SDSs for chemicals containing toluene diisocyanate, a known 
respiratory sensitizer, and found only half the SDSs noted asthma as a 
potential health effect, and one in four noted neither asthma nor 
respiratory sensitization effects. Other studies have also examined the 
increasing concerns about occupational asthma (Document ID 
0588, 0591, 0592, and 0593).
    Further, the most recent science shows that respiratory and skin 
sensitization can be caused at very low concentrations. A 2006 paper by 
Arts et al. summarizes human and animal studies on skin and respiratory 
sensitizers, and finds that sensitization effects often result from 
exposures to chemicals at concentrations below 1% in studied 
populations (Document ID 0593). Likewise, the World Health 
Organization's report, ``Skin Sensitization in Chemical Risk 
Assessment,'' also reports positive results for skin sensitization well 
below the 1% cut-off used by the current HCS (Document ID 
0586). Moreover, once an individual is sensitized, a response 
can be triggered at even lower levels than those required initially to 
induce sensitization (Document ID 0585 and 0593). OSHA has 
often used sensitizers as an example of why SDS preparers need to 
consider whether information should be provided below the 1% cut-off. 
For example, in OSHA's compliance directive for the HCS (CPL 02-02-
038), the following guidance is given:

    If the components of a mixture could be released in 
concentrations which would exceed an OSHA PEL, an ACGIH TLV, or 
could present a health risk to employees, information on these 
components must be included on the MSDS regardless if their final 
concentration in the mixture is less than 1% (or 0.1% for 
carcinogens). For instance, TDI is a sensitizer at very small 
concentrations and despite its low concentration in a mixture, can 
be offgassed in quantities which may present a health risk that must 
be noted on the MSDS.

    But sensitization is not the only effect of concern. Reproductive 
toxicity is a serious hazard that includes both fertility and effects 
on the offspring. Recent research concerning endocrine disruptors 
suggests that these chemicals can have adverse reproductive effects at 
very low levels (Document ID 0583, 0584, and 626). Likewise, 
occupational disease mortality and morbidity statistics indicate a 
number of cases related to target organ effects as well (Document ID 
0291, e.g., heart disease and renal effects).
    OSHA proposed to use the most protective of the GHS concentration 
limits for these hazard classes. For sensitizers and reproductive 
toxins, the final rule requires 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. However, as indicated, 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. (On 
the other hand, it should be noted that OSHA was persuaded that the 
current 1% cut-off may be too conservative for many acute toxins and 
Category 3 Single Target Organ Toxicants, and the final rule is likely 
to result in fewer mixtures being covered for these effects than under 
the current approach.)
    In addition to concerns regarding protection for these health 
effects, there is also a concern about the communication difficulties 
of having different hazard information on a label versus a safety data 
sheet. As indicated, the GHS negotiators agreed that all countries 
would use the lower levels in the criteria for providing information on 
SDSs. Using a different cut-off for labels would create a situation 
where there may be hazards on the SDS that do not appear on a label. 
This inconsistency makes training more difficult, and creates confusion 
for downstream employers as well when they are deciding about 
appropriate protective measures. Under the current rule, the mixture 
cut-offs apply to both the label and the SDS. Several commenters 
indicated that OSHA should provide guidance indicating specific 
threshold cut-offs (Document ID 0344, 0381, and 0399). The 
table below indicates what the cut-offs are for different health 
hazards. These commenters also suggested OSHA provide guidance on 
opting out of the cut-offs if data override the threshold. This is 
already addressed in A.0.4.3.2 (if the classifier has information that 
the hazard of an ingredient will be evident (i.e., it presents a health 
risk) below the specified cut-off/concentration limit, the mixture 
containing that ingredient shall be classified accordingly). A.0.4.3.3 
also allows the cut-off/concentration limit to be higher in exceptional 
cases. The evaluator must have conclusive data demonstrating that the 
hazard of an ingredient will not present a health risk. OSHA 
anticipates that the criteria of A.0.4.3.3 would rarely permit this 
approach to be used.

                              Table XIII-1
------------------------------------------------------------------------
           Hazard class               Label cut-offs      SDS cut-offs
------------------------------------------------------------------------
Respiratory/Skin sensitization....             >=0.1%             >=0.1%
Germ cell mutagenicity (Category               >=0.1%             >=0.1%
 1)...............................
Germ cell mutagenicity (Category               >=1.0%             >=1.0%
 2)...............................
Carcinogenicity...................             >=0.1%             >=0.1%
Reproductive toxicity.............             >=0.1%             >=0.1%
Specific target organ toxicity                 >=1.0%             >=1.0%
 (single exposure)................
Specific target organ toxicity                 >=1.0%             >=1.0%
 (repeated exposure)..............
Specific target organ toxicity                   >20%               >20%
 Category 3.......................
------------------------------------------------------------------------

    During the hearing, worker representatives were asked to comment on 
whether consistency between the information on the label and the SDS 
was important for worker protection. They all indicated that it was 
important. For example, Mr. Platner, who represented the Building and 
Construction Trades Department of the

[[Page 17713]]

AFL-CIO stated (Document ID 0494 Tr. 25):

    Oh, absolutely. An example of a sensitizer that's very common is 
isocyanate components or polyurethane spray foams or coatings. 
They're potent sensitizers, and that information very rarely gets to 
the label. It's usually appropriately in the MSDS, but it rarely 
makes it to the label.

    Similarly, Mr. Kojola of the AFL-CIO, commented (Document ID 
0494 Tr. 33):

    Oh, absolutely. What it does is it provides a consistent message 
that workers are getting both in labels and on safety data sheets. 
And I think it enhanced the ability to, for example, translate that 
information into other languages, so I think that alone is a major 
step forward in enhancing worker protection.

    Some commenters argued that OSHA should adopt the higher cut-off 
levels where given a choice by the GHS (Document ID 0344, 
0361, 0367, 0371, 0376, 0381, 0392, and 0393). They questioned whether 
there was a scientific justification for the lower levels, and 
suggested that the U.S. should harmonize with the EU approach.
    As OSHA described above, there are two primary reasons for the 
lower levels. First, OSHA believes it is important for effective 
communication to have the same hazards on the label and SDS to as great 
a degree as possible. Labels are in an employee's work area, and thus 
provide the most immediate source of information. While SDSs must be 
available, they are longer and more complicated, and workers are less 
likely to review them on a regular basis. For downstream employers, it 
is also important to maintain consistency and reduce confusion where 
possible by having the information on hazards the same on the label and 
SDS.
    Secondly, as discussed above, increased knowledge of these health 
effects in the scientific literature, as well as studies indicating 
that they are often not reported when they should be, or the 
information is lacking, has led OSHA to the conclusion that 
communication at the lower levels is appropriate and necessary for 
worker protection. It is particularly critical in the area of 
sensitizers since the incidence of occupational asthma is increasing, 
and sensitization can occur at lower levels as it progresses. But with 
the advent of information on effects like those of endocrine 
disruptors, and the increased awareness of the possible effects of low 
levels of exposure, it is necessary for all of these effects.
    As for the argument regarding consistency with the EU, OSHA has 
sought to be consistent where possible. However, the EU has a different 
regulatory structure for dealing with these effects downstream, and 
what is appropriate for their classification and labeling system is not 
necessarily appropriate for ours in the U.S. (See, e.g., http://ec.europa.eu/environment/chemicals/dansub/pdfs/30_atp.pdf: ``Under 
Directive 76/769/EEC on the restrictions of certain dangerous 
substances and preparations, the Commission is, in principle, obliged 
(within six months of the publication of the classification) to propose 
a ban on their placing on the market and use by consumers as substances 
or in preparations (above specified concentrations).'')
    There are relatively few chemicals for which there are data 
indicating the types of effects of concern with regard to these lower 
cut-offs (e.g., sensitizers), and fewer still that would fall into the 
range between the lower and higher cut-offs (e.g., between 0.1% and 
0.3% for reproductive toxicity). Furthermore, as suggested in one 
comment, disclosing at different levels on labels versus SDSs may 
actually create a product liability issue under U.S. law that would 
argue against taking such an approach (Document ID  0353). 
While product liability is not one of the issues that influenced OSHA's 
decision-making, it may be important to these commenters in the future.
    The American Chemistry Council asked during the hearing why OSHA 
adopted the cut-off levels 25 years ago if the Agency thought they 
weren't protective, or whether there is information to indicate that 
they have not been protective (Document ID  0494 Tr. 174). In 
response to questions from OSHA as to what the scientific basis would 
be for communicating a hazard on an SDS and not a label, they responded 
(Document ID  0494 Tr. 177): ``A scientific basis? Well, most 
of these are obligatory regulatory cut-offs for mixtures. There really 
is not much scientific basis for any of the mixture cut-offs.'' In 
other words, ACC concedes that there is also no scientific basis for 
the higher cut-offs it advocates--rather the EU cut-offs are simply 
policy choices made by a different authority with a distinct regulatory 
structure. As described previously, OSHA believes there is evidence 
that these cut-offs are no longer sufficiently protective in light of 
additional information developed since the HCS was adopted in 1983. 
Furthermore, having inconsistencies in information on a label versus a 
safety data sheet impacts the effectiveness of the communication to 
workers and downstream employers. The cut-offs/concentration levels in 
the final rule are the same as proposed, and are the lower levels of 
those the GHS allows countries to choose from when implementing.
    The Styrene Information and Research Center (SIRC) argues that OSHA 
may not lower the mixture cut-off thresholds for sensitizers and 
reproductive toxicants without establishing that a significant risk 
exists at that lower threshold (Document ID 0361, 0467, and 
0642). OSHA disagrees.
    As discussed in Section V, Pertinent Legal Authority, OSHA has 
found that inadequate hazard communication creates a significant risk 
and that the final rule will reduce that risk. Contrary to what the 
SIRC says, OSHA need not support each requirement in a standard with 
its own significant risk finding. Public Citizen Health Research Group 
v. Tyson, 796 F.2d 1479, 1502 n. 16 (D.C. Cir. 1986). Indeed, when the 
Supreme Court first construed the OSH Act as imposing a significant 
risk requirement, it spoke in terms of the Agency making findings about 
unsafe workplaces, not individual hazards. Benzene, 448 U.S. at 642 
(``before promulgating any standard, the Secretary must make a finding 
that the workplaces in question are not safe [and] * * * a workplace 
can hardly be considered `unsafe' unless it threatens the workers with 
a significant risk of harm''). See also, for example, id. (framing the 
``significant risk'' requirement as requiring OSHA ``to make a 
threshold finding that a place of employment is unsafe--in the sense 
that significant risks are present and can be eliminated or lessened by 
a change in practices.''); Texas Indep. Ginners Ass'n v. Marshall, 630 
F.2d 398, 400 (5th Cir. 1980) (``The Supreme Court recently ruled that 
the Act requires OSHA to provide substantial evidence that a 
significant risk of harm arises from a workplace or employment.''). 
Moreover, courts have held that the OSH Act does not require the 
disaggregation of significant risk analyses along other lines. See, for 
example, Lockout/Tagout II, 37 F.3d at 670 (upholding OSHA's decision 
not to conduct individual significant risk analyses for various 
affected industries); American Dental Ass'n v. Martin, 984 F.2d 823, 
827 (7th Cir. 1993) (OSHA is not required to evaluate risk ``workplace 
by workplace''); Associated Builders and Contractors, Inc. v. Brock, 
862 F.2d 63, 68 (3d Cir. 1988) (``the significant risk requirement must 
of necessity be satisfied by a general finding concerning all 
potentially covered industries'').
    Indeed, a contrary rule would impose an unworkable burden on OSHA. 
As the Third Circuit held Associated Builders and Contractors, Inc. v. 
Brock, 862 F.2d 63 (3rd Cir. 1988), stating:


[[Page 17714]]


    The holdings in USWA I and USWA II sustained a general 
significant risk finding. Assuming, however, that those opinions 
were construed as leaving open the significant risk issue, as 
presently presented, the outcome would be no different. This 
rulemaking proceeding produced a performance-oriented information 
disclosure standard covering thousands of chemical substances used 
in numerous industries. For such a standard the significant risk 
requirement must of necessity be satisfied by a general finding 
concerning all potentially covered industries. A requirement that 
the Secretary assess risk to workers and need for disclosure with 
respect to each substance in each industry would effectively cripple 
OSHA's performance of the duty imposed on it by 29 U.S.C. Sec.  
655(b)(5); a duty to protect all employees, to the maximum extent 
feasible.

Id. at 68. Thus, OSHA need not make the sort of significant risk 
finding suggested by SIRC.
    Rather, once OSHA makes a general significant risk finding in 
support of a standard, the next question is whether a particular 
standard's requirements are reasonably related to the purpose of the 
standard as a whole. Asbestos Information Ass'n/N. Am. v. Reich, 117 
F.3d 891, 894 (5th Cir. 1997); Forging Indust. Ass'n v. Secretary of 
Labor, 773 F.2d 1436, 1447 (4th Cir. 1985); United Steelworkers of Am., 
AFL-CIO-CLC v. Marshall, 647 F. 2d 1189, 1237-38 (D.C. Cir. 1980). The 
use of a threshold to govern when the standard applies is reasonably 
related to the purposes of hazard communication. It limits 
communication to those situations in which a chemical is present in 
sufficient quantities that workers might experience substantial 
exposures to its hazards. Hazard communication can be undermined just 
as much by overcommunication of risks as by undercommunication. An 
avalanche of information about less significant hazards on a label or 
SDS could obscure important information on substantial hazards faced by 
the worker. Thresholds also save manufacturers and importers the burden 
of evaluating and listing chemicals present in only small quantities 
and not likely to result in substantial exposures (48 FR 53280, 53290 
(Nov. 25, 1983). And as noted above, OSHA has provided a justification 
for the lower levels challenged by the Styrene Institute and Research 
Center: chemicals presenting these hazards may be especially hazardous 
at low levels, and the potential effects are of high concern.
    In addition, SIRC seems to challenge only the reduction of the 
threshold for disclosure on labels, not the identical reduction of the 
threshold for disclosing the hazard on SDS for these hazards. Under the 
final rule, the same information for sensitizers and reproductive 
toxicants must appear on both the label and the SDS, avoiding the 
potential for confusion. The reproductive toxicant and sensitizer cut-
offs are reasonably related to the purposes of the Hazard Communication 
Standard.
    The courts have upheld similar requirements even in the absence of 
a significant risk finding, provided the requirements were reasonable. 
In National Cottonseed Products Ass'n v. Brock, 825 F.2d 482, 487 (D.C. 
Cir. 1987), the court upheld medical monitoring for cottonseed workers 
where OSHA found no significant risk. OSHA had eliminated the PEL but 
imposed the monitoring as a ``backstop'' to the ``no significant risk'' 
determination, and the court upheld the monitoring requirement because 
the ``evidence indicates that there is a real possibility of 
significant health risks'' where no PEL was imposed. Likewise, in 
National Mining Ass'n v. MSHA, 116 F.3d 520, 527-28 (D.C. Cir. 1997), 
the court upheld MSHA's decision to require oxygen at a 19.5% level, 
even though the evidence only showed that adverse worker effects were 
experienced at a lower level of 18%. The proper minimum oxygen level 
was ``a technical decision entrusted to the expertise of the agency,'' 
which was ``entitled to `err' on the side of overprotection.'' Id. at 
528. And in Public Citizen, the court upheld a requirement to post 
signs to warn employees of the hazards presented by ethylene oxide 
exposures without a separate significant risk determination, noting 
that signs and labels were specifically contemplated by section 6(b)(7) 
of the OSH Act and a ``reasonably necessary and appropriate'' part of a 
standard. 796 F.2d at 1502 n.16.
    As explained in the Pertinent Legal Authorities section, the 
mixture cut-off levels are part of the HCS's general approach of 
providing prophylaxis against the exposure to significant risks, 
similar to the medical monitoring requirement in National Cottonseed, 
the higher oxygen level requirement in National Mining Ass'n, and the 
sign requirement of Public Citizen. The mixture cut-off thresholds are 
supported by substantial evidence, as discussed above and, therefore, 
authorized by the Act.
    A related issue is the cut-off in Category 3 of Specific Target 
Organ Toxicity, both in Single Exposure and Repeat Exposure. Under the 
GHS, a cut-off/concentration limit of 20% is suggested as guidance. It 
is an additive cut-off, meaning that the percentages of the ingredients 
that meet the definition for Category 3 would be added together and 
compared to the cut-off. Consistent with other revisions to the GHS 
language that are appropriate for a mandatory standard versus a non-
mandatory recommendation, OSHA proposed to make the 20% cut-off 
mandatory, but requested comment on it. (74 FR 50282, Sept. 30, 2009; 
see also A.8.3.4.5 and A.9.3.4.4.) A limit that is not mandatory will 
be difficult for chemical manufacturers to know how to comply with, and 
it will also be difficult for OSHA to enforce. Furthermore, OSHA views 
this provision as relaxing the current requirement, which is a cut-off 
of one percent for each of the ingredients in the mixture that are in 
and of themselves hazardous. However, consistent with A.0.4.3.2, if the 
classifier has information that the hazard will be evident below the 
specified concentration limit, the mixture is to be classified 
accordingly. Therefore, where the 20% is too high, the classifier will 
nevertheless be required to classify it appropriately below that level.
    There were a number of commenters who supported making the 20% 
level mandatory, suggesting that it was reasonable for the U.S., 
promoted consistency, and that the level could be lower if data warrant 
(See, e.g., Document ID 0313, 0324, 0327, 0329, 0330, 0338, 
0339, 0353, 0365, 0381, 0410, and 0412). Others did not agree (Document 
ID 0323, 0328, 0344, 0376, 0379, 0382, 0393, 0399, and 0405). 
Some of these commenters suggested that OSHA should provide data to 
support making it mandatory. The GHS is drafted in voluntary terms, but 
the HCS is a mandatory standard, meaning that all of its provisions are 
mandatory as well. OSHA is unaware of specific data one way or the 
other on the question, but notes that this is a significant relaxation 
of the applicable cut-off under the current rule. Given the minor 
hazard presented by these chemicals, OSHA believes the 20% cut-off is 
appropriate to guard against overwarning. Because no alternatives were 
presented (other than making the provision voluntary, which is not an 
acceptable solution), OSHA has included the mandatory requirement in 
the final rule. Again, as noted above, chemical manufacturers or 
importers are still required to classify mixtures at lower 
concentrations if they have evidence that it presents a hazard, so OSHA 
does not believe the final rule is less protective.
    Acute toxicity. In Appendix A, Chapter A.1 (``Acute Toxicity''), 
OSHA proposed to adopt GHS Categories 1 through 4, but not 5. The 
current

[[Page 17715]]

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 three 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, the EU covered them under their 
previous 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.
    Adopting 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 in the ANPR, 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 0021, 0046, 0047, 0077, 0104, 
0123, 0135, 0145, 0155, 0163, and 0171). For example, Dow (Document ID 
0047) stated:

    Dow believes that OSHA should adopt all health hazard criteria 
and categories, except Acute Toxicity Category 5. While this 
category may be useful for characterizing consumer products, its use 
with the substances characterized under the HCS would be confusing 
and unnecessary. Dow understands that the EU and Australia have both 
chosen not to include Acute Toxicity Category 5 in their 
implementation of the GHS and that Canada is currently considering 
doing the same. Dow believes that the U.S. should be consistent with 
these other major trading partners by not including this category 
when it adopts the GHS.

    Others suggested that OSHA propose to adopt Categories 1 through 3 
(Document ID 0034, 0128, and 0141). Some argued that all 
categories should be adopted to ensure harmonization (See, e.g., 
Document ID 0018, 0036, 0050, 0078, 0106, and 0116).
    OSHA believes that coverage provided by 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 provided by Category 5, OSHA does not preclude 
inclusion of information on Category 5 on the label or the SDS. 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. As noted earlier, 
commenters on the NPRM supported the categories chosen by OSHA, except 
for a few who thought OSHA should adopt all categories in the GHS to 
promote complete harmonization. However, OSHA believes that this 
concern is addressed by permitting such categories to be addressed on 
labels and SDSs with no penalty.
    OSHA did not propose to adopt Category 5. The final standard does 
not adopt Category 5, nor include it in Table A.1.1, which describes 
the criteria for acute toxicity. However, calculations for the acute 
toxicity of mixtures that are comprised of one or more ingredients that 
fall into Category 5 must include the acute toxicity estimate for the 
Category 5 ingredients. Proposed Paragraph A.1.3.6.1(a) indicated that 
the calculation of the acute toxicity of mixtures would ``[i]nclude 
ingredients with a known acute toxicity, which fall into any of the 
acute toxicity categories.'' This is consistent with the GHS 
(Subparagraph 3.1.3.6.1(a)).
    As discussed in the Proposal, OSHA believes that the exclusion of 
Category 5 from the criteria Table A.1.1 may lead to classifiers 
overlooking substances falling into this category in the mixture 
calculation, which could result 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. To avoid this situation, 
OSHA has clarified the text for the mixture calculation to ensure that 
the ingredients that would be classified as Category 5, and thus would 
not be classified under the HCS, are included in the mixture 
calculation. Paragraph A.1.3.6.1(a) has been modified to indicate the 
calculation must ``[i]nclude ingredients with a known acute toxicity, 
which fall into any of the acute toxicity categories, or which have an 
oral or dermal LD50 greater than 2000 but less than or equal 
to 5000 mg/kg body weight (or the equivalent dose for inhalation);''.
    OSHA has modified the text of Note (d) to Table A.1.1 to help 
clarify the requirements. This was done in response to a comment from 
Dow (Document ID 0526), which stated that they were ``confused 
about the table,'' and that OSHA should revisit the table and the 
definitions to properly harmonize the provisions.
    Several commenters noted that there were errors in Table A.1.2 in 
the NPRM (Document ID 0376, 0393, and 0405). The errors have 
been corrected in the final rule.
    One commenter stated that the criteria seem to assume that acute 
lethality data are available in all situations, and they are not 
(Document ID  0321). As with all other health hazard criteria 
in the standard, the HCS does not require data to be generated to 
comply with the standard. And the final rule recognizes that many 
chemicals have not been tested to ascertain their hazards. For example, 
the formula used to calculate the acute toxicity of a mixture makes an 
adjustment for ingredients whose acute toxicity is unknown. In 
addition, the fact that a mixture contains an ingredient of unknown 
toxicity must be indicated on the label and SDS. This is important 
because in some mixtures the unknown percentage could be significant, 
and therefore the estimation of toxicity for the mixture has less 
credibility than in a situation where the majority of the ingredients 
have data available.
    It was also suggested that the formula used for acute toxicity be 
displayed in a way that is more commonly used for such equations 
(Document ID 0641). OSHA agrees that it could be displayed in 
a different way, but wanted to ensure it appeared the same in the 
regulatory text as it appears in the GHS. However, in guidance for 
application of the final rule, OSHA will include the formula in the 
alternative format as well to assist in understanding it.
    The Styrene Information and Research Center (SIRC) challenged the 
proposal's requirement to disclose the concentration of ingredients in 
a mixture whose acute toxicity was unknown (Document ID 0361). 
It argued that ``[i]t is unclear how that requirement would pass a 
significant risk test'' and that ``[i]t seems unlikely to make the user 
more cautious.'' However, the record shows the contrary. Both workers 
and union representatives testified at the public hearing on this 
rulemaking that workers would be more cautious when dealing with 
chemicals of unknown toxicity and would look for substitutes where 
possible (Document ID 0494). Further, Cathy Cole, President of 
the American Industrial Hygiene Association, testified that industrial 
hygienists use the fact that a chemical's acute toxicity is unknown 
when they perform qualitative risk

[[Page 17716]]

assessments. She testified (Document ID 0496 Tr. 425):

    [W]e would take that information and use it to weigh it against 
all the other information within that mixture. If there's an 
unknown, then we would most likely provide a safety factor as we did 
our risk assessment * * *. If there's a mixture that has a number of 
unknowns, then we would treat that very carefully and we would have 
a high risk ranking for it.

    The final rule's hazard classification scheme for mixtures 
presenting acute toxicity hazards treats unknown toxicity in a similar 
way. When testing data on the mixture as a whole are not available, the 
acute toxicity of the mixture is determined by assuming that the 
nontoxic ingredients dilute the toxicity of the acutely toxic 
ingredients. (See A.1.3.6.2.) However, where the acute toxicity of a 
particular ingredient is not known, the final rule excludes it from the 
toxicity calculation. (A.1.3.6.2.4.) In effect, this means that 
ingredients with unknown toxicity are assumed not to dilute the 
toxicity of the known acute toxicants. This approach reflects the same 
cautious treatment of ingredients having unknown acute toxicity that 
the witnesses testified to, as discussed above. In addition, it is 
necessary to disclose the concentration of ingredients with unknown 
toxicity because downstream users need that information to classify any 
products they make with the mixture.
    OSHA has also made two minor, clarifying changes to paragraph 
A.1.3.6.2.4 that are consistent with changes that were approved by the 
UN Sub-committee in December. The word ``relevant'' has been added in 
front of ``ingredient,'' and the word ``total'' was deleted before 
``percentage.'' Therefore, A.1.3.6.2.4 in the final rule requires that 
if the total concentration of the relevant ingredient(s) with unknown 
acute toxicity is <=10% then the following formula must be used:
[GRAPHIC] [TIFF OMITTED] TR26MR12.047

    However, if the total concentration of the relevant ingredient(s) 
with unknown acute toxicity is >10%, the formula presented above is 
corrected to adjust for the percentage of the unknown ingredient(s) as 
follows:
[GRAPHIC] [TIFF OMITTED] TR26MR12.048

    The above discussion shows that SIRC's concerns about the unknown 
toxicity requirement are unfounded. Employers use the fact that a 
chemical's acute toxicity is unknown in determining how chemicals 
should be handled. As such, the disclosure requirement is reasonably 
related to the purpose of hazard communication and, therefore, within 
OSHA's authority. In addition, by providing the worker with information 
about the limits of the known information, the requirement provides the 
sort of prophylactic function that has been upheld even in situations 
where the Agency has not made a significant risk finding. The unknown 
toxicity requirement is consistent with the OSH Act.
    Another commenter suggested the trade secret provisions should 
apply to the requirement for disclosing the concentration of 
ingredients with unknown toxicity (Document ID 0353). The 
revised rule (and the GHS) do not suggest that the names of the 
components be disclosed--simply the aggregate percentage of the total 
composition that has unknown acute toxicity. So if there are three 
ingredients in a mixture that have no acute toxicity data available, 
and they comprise 20% of the mixture, the label and SDS must indicate 
that 20% of the mixture has unknown acute toxicity. The names of the 
chemicals do not have to be disclosed, and neither does the number of 
chemicals involved. Therefore, there should be no trade secret issue.
    Skin corrosion/irritation. OSHA proposed to adopt Categories 1 and 
2, but not Category 3, for skin corrosion/irritation. Category 3 covers 
more than the criteria for this hazardous effect under the current 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 ANPR comments supporting such an approach 
(Document ID 0034, 0077, 0128, 0145, and 0171). This approach 
is also consistent with the European Union.
    As OSHA noted in the preamble to the NPRM (74 FR 50392-93, Sept. 
30, 2009), significant editing was done to the GHS text for this health 
hazard. The criteria in the GHS lead the evaluator to conduct 
additional testing when information is not available. While the GHS 
does not require testing, the criteria imply that it should be done to 
complete an evaluation. This implication is not acceptable under the 
HCS, which is based solely on available evidence.
    As noted in the NPRM discussion, work had already been initiated in 
the UN Sub-committee to modify the chapter on skin corrosion/irritation 
to address inconsistencies and clarify provisions. That work has 
proceeded since the NPRM, and is on the work program for the next two 
years as well. OSHA has made modifications to the HCS criteria to 
reflect discussions in the Sub-committee, and clarify areas of concern. 
In particular, Chapter A.2 of Appendix A, ``Skin Corrosion/
Irritation,'' was reorganized in the final rule so that text and 
figures are consistent. Paragraph A.2.1's title was changed to 
``Definitions and general considerations.'' Paragraph A.2.1.2 was added 
to introduce a tiered approach to follow when classifying for skin 
corrosion/irritation. Paragraph A.2.2, ``Classification criteria for 
substances using test data,'' has been modified to reflect that it 
covers animal test data. In Paragraph A.2.3, ``Irritation,'' the 
factors used to determine the corrosion/irritation potential of a 
substance were deleted, and the text was reorganized to follow the 
tiered approach to classify substances using other data elements. 
Figure A.2.1 was updated to make it consistent with the text, and to 
show the tiered evaluation scheme instead of a testing scheme. Comments 
had been received that indicated this figure was confusing (Document ID 
0344 and 0381). Another commenter noted that the criteria are 
provided without indicating how they were derived (Document ID 
0321). The criteria were developed by a group of experts in 
the OECD and were derived from the existing criteria of the countries 
involved. They do not specify a test method because the GHS is test 
method neutral, but the OECD testing guidelines are generally agreed to 
provide the type of information needed for classification under the 
GHS.
    There were also several comments that pH criteria are not 
appropriate to use in some situations (for example, the pH of the 
ingredients in a mixture may not predict the pH of the mixture) 
(Document ID 0321, 0335, and 0381). The criteria recognize 
that test data for these effects provide better information

[[Page 17717]]

to base a classification on, but pH information can be of assistance 
when such data are not available.
    OSHA believes the edits and changes make the chapter less confusing 
and clarify that testing is not required to achieve compliance. The 
basic provisions and approach remain the same as the GHS. The Agency is 
participating in the continuing work of the UN Sub-committee on this 
topic, and will revise the HCS if any additional clarifications are 
made in the criteria for these hazards that will help classifiers 
follow the provisions.
    Serious eye damage/irritation. Proposed Appendix A, Chapter A.3 
(``Serious Eye Damage/Eye Irritation''), did not include the criteria 
for Category 2B of eye irritation, but addressed the label elements for 
the category in Appendix C. A number of commenters indicated that OSHA 
should include the criteria for Category 2B (Document IDs 
0344, 0351, 0367, 0371, 0381, and 0393), clarify coverage of 
Category 2B (Document ID 0376 and 0382), or exclude it 
(Document ID 0405). The omission of the criteria was an 
oversight, and OSHA has added the criteria for Category 2B to the final 
rule.
    The text for GHS Chapter 3.3, ``Serious Eye Damage/Eye 
Irritation,'' posed similar issues to those described above for skin 
corrosion/irritation. The criteria in the GHS implied that testing 
might be needed to complete classification in the absence of data. This 
is required by neither the GHS nor the HCS. OSHA made a number of 
modifications to the parallel text in Appendix A, Chapter A.3, of the 
HCS proposal to address the perception that testing might be required 
when it is not. And the UN Sub-committee is also reviewing this chapter 
for purposes of clarifying the requirements.
    As with the skin chapter, in the final rule OSHA has reorganized 
Chapter A.3 so that the text and figures are consistent, and so that it 
is clear that what must be followed is a tiered approach. The title of 
A.3.1 was modified to indicate it covers definitions and general 
considerations, and paragraph A.3.1.2 was added to introduce the tiered 
approach for classification. Paragraph A.3.2 (``Classification criteria 
for substances using animal test data'') was modified to indicate it 
addresses animal data. Table A.3.1 was modified to indicate that 
Category 1 corresponds to Serious Eye Damage and not to eye irritants, 
and Table A.3.2 adds the criteria for Category 2B. In A.3.3 
(``Classification criteria for substances using other data elements''), 
the classification criteria for substances were reorganized using other 
data elements to make it consistent with Figure A.3.1, and to show the 
tiered evaluation strategy for classification. Figure A.3.1 was updated 
to make it consistent with the text. And Table A.3.3 now has a note to 
indicate that a mixture may be classified as Category 2B in cases when 
all relevant ingredients are classified as Category 2B. As with skin 
corrosion/irritation, OSHA will continue to monitor work in the UN Sub-
committee to clarify these criteria, and will modify the rule to update 
the chapter as necessary if changes are made.
    One additional issue was raised concerning the coverage of the GHS 
criteria for eye irritation in comparison to current criteria used by 
CPSC and EPA. The National Toxicology Program Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) (Document 
ID 0384) suggests that the GHS criteria are not as protective 
as the current criteria used by CPSC and EPA. OSHA uses the CPSC 
criteria in the current HCS, but does not use EPA criteria. NICEATM did 
an analysis of a group of chemicals to determine what their 
classifications would be under the different criteria, and concluded 
that at least 14 of 149 chemicals it reviewed (17%) would not be 
classified under the GHS criteria, but would have been under current 
HCS criteria.
    OSHA asked a consulting toxicologist familiar with the GHS criteria 
to review the comment and the analysis, and the results of his review 
have been entered into the public record (Document ID 0576, 
0577, and 0578). The results of this review show that all of the 14 
chemicals are differently classified because they present transitory 
effects that resolve in 72 hours or less; the difference in 
classification results from the way each method accumulates transitory 
positive results across test animals. While there may be some 
differences in conclusions made under the differing criteria, the 
differences are less pronounced when variance in transient effects is 
considered (as it is under the criteria as proposed). This is explained 
as follows in the toxicologist's report:

    In order to compensate for this difference in approaches, OSHA 
has proposed to also adopt the GHS concept of ``pronounced 
variability''. Under this concept, for those chemicals where there 
is pronounced variability among animal responses, such information 
may be taken into account in determining the classification. As 
discussed specifically under OSHA's proposed criteria for 
Classification and Categorization of Skin Corrosion/Irritation, but 
only mentioned in passing under Serious Eye Damage/Eye Irritation, 
this notion would allow for classification in cases where there are 
very definite, positive irritant effects related to chemical 
exposure in a single animal, but the overall data set does not 
support classification. In cases where the response is borderline 
but persistent or severe but transient, the Assessor would likely 
classify a substance as irritating. It is noted that there are at 
least two chemicals among those under examination where ``pronounced 
variability'' would likely cause the Assessor to classify them as 
irritants (see data for ethyl thioglycolate and glycidyl 
methacrylate; fomesafen, 2,2-dimethyl-3-pentanol, and cellosolve 
acetate might also be classified as irritants under this concept).

The final rule retains the pronounced variability language at A.2.2.2.2 
and A.3.2.3. The toxicologist also noted that:

    Finally, a quick search of secondary and tertiary sources 
available on-line indicates that 12 of the 14 chemicals in question 
would be classified as hazardous materials under both the current 
and proposed classification criteria. Those that would not be 
classified are N,N-dimethylguanidine sulfate (sub-EU classification 
eye and skin irritation responses; not a sensitizer; no other data 
found); and tetraaminopyrimidine sulfate (not an acute or chronic 
toxicant; identified as non-irritating by EU Scientific Committee on 
Cosmetic Products and Non-Food Products intended for Consumers 
(SCCNFP)).

Therefore, although the chemical may not be addressed as an eye 
irritant, it would still be considered a health hazard under the GHS--
and the HCS--and thus have information available about its effects on 
labels and SDSs.
    While OSHA appreciates the concerns raised by NICEATM, the criteria 
are being finalized as proposed, other than the modifications made for 
clarification purposes. It appears that the pronounced variability 
considerations will address some of the concerns raised, and that the 
primary remaining differences involve transient effects of relatively 
low concern. Both CPSC and EPA were involved in the development of the 
criteria in the GHS, and were aware of the differences between their 
existing systems and the agreed harmonized criteria. In harmonizing 
between the existing systems, the criteria selected were between what 
currently exists in the U.S. and in the EU. The classification criteria 
in each existing system is not a bright line determined by science, but 
rather a scientifically influenced policy determination, and as 
discussed elsewhere, an inevitable part of adopting harmonized criteria 
is that a few borderline chemicals might be dropped. No other 
stakeholders have raised the issue of whether the criteria are 
protective enough. OSHA is proceeding with the final rule because it 
believes that in this situation,

[[Page 17718]]

maintaining harmonization with the GHS is ultimately more important for 
worker health. This situation will continue to be monitored as 
implementation takes place to ensure that it is appropriate.
    Respiratory or skin sensitization. The final rule makes only minor 
changes to the proposed text of Appendix A, Chapter A.4, ``Respiratory 
or Skin Sensitization.'' The footnotes have been re-numbered since they 
were out of sequence in the NPRM. And the term EC3 has been explained 
in a footnote to Tables A.4.3 and A.4.4 (estimated concentration of 
test chemical required to induce a stimulation index of 3 in the local 
lymph node assay).
    The GHS criteria for respiratory and skin sensitizers have one 
category for each type of sensitization, but also give the option of 
dividing that one category into two sub-categories, which involves a 
differentiation in the type of evidence available. In the NPRM, OSHA 
proposed to adopt the sub-categories for classification. One commenter 
strongly supported adopting sub-categories for these sensitizers 
(Document ID 0381), while another did not support it because 
the EU has not adopted sub-categories (Document ID 0376). OSHA 
is adopting the sub-categories as proposed. However, the Agency 
recognizes that there are situations where data are not available to 
place the chemical into one of the sub-categories. The GHS itself 
addresses this in 3.4.2.1.1.1 (respiratory sensitization), and 
3.4.2.2.1.1 (skin sensitization). Therefore, under the revised HCS, 
simply classifying the chemical as Category 1 will be sufficient in 
cases where data are insufficient to assign a subcategory. The American 
Chemistry Council (Document ID 0393) suggested that more 
guidance is needed to differentiate potential and severe sensitizers 
for placement into the sub-categories. OSHA believes that this type of 
guidance should be developed through the Sub-committee process, rather 
than by countries independently developing guidance for application. 
The Agency will consider requesting the Sub-committee to develop such 
guidance.
    Germ cell mutagenicity. The comments on this health hazard centered 
on whether or not it should be included in Appendix A. Procter & Gamble 
(Document ID 0381) and the American Chemistry Council 
(Document ID 0393) argued that it should not be included. The 
Soap and Detergent Association (Document ID 0344) also argued 
for exclusion, but said if it is included, only Category 1A should be 
covered. Ecolab (Document ID 0351) also argued that only 
Category 1A should be covered. These commenters argued that it is 
already covered by reproductive toxicity and carcinogenicity, and 
adding a separate hazard class would create a training burden.
    OSHA disagrees. First, while the current HCS does not define 
mutagenicity as a separate health hazard, it is covered by the 
reproductive toxin definition. Under the GHS, mutagenicity is not 
covered by reproductive toxicity, and OSHA's failure to adopt the 
mutagenicity category would render the final less protective than the 
current HCS. The hazard class will have to be adopted to maintain 
coverage. Secondly, though mutagenicity data are used to predict 
carcinogenicity, the mutagenicity hazard is not covered by the 
carcinogenicity criteria. Furthermore, little additional burden for 
training can be claimed for what is already covered under reproductive 
toxicity in the current HCS.
    All of these commenters argue that the HCS should be as consistent 
with the EU as possible. The EU has already adopted these criteria, so 
excluding them would not be consistent with the EU. OSHA is maintaining 
the hazard class as part of the HCS, and including both categories. It 
is OSHA's understanding that at present there are no chemicals that 
meet the criteria for Category 1A, so currently this has no burden 
associated with it--although there may be minimal burdens if new data 
in the future place chemicals in this category. (See, e.g., Annex VI to 
the EU's former directive on classification and labeling, which states: 
``To place a substance in category 1, positive evidence from human 
mutation epidemiology studies will be needed. Examples of such 
substances are not known to date. It is recognized that it is extremely 
difficult to obtain reliable information from studies on the incidence 
of mutations in human populations, or on possible increases in their 
frequencies.'') Chemicals in Category 2 are frequently used already in 
discussions of potential carcinogenicity, since mutagenicity test 
results are used to predict carcinogenicity. Thus, there is little 
burden associated with adopting that category either. Therefore, OSHA 
has retained Appendix A, Chapter A.5, ``Germ Cell Mutagenicity.''
    OSHA included a new heading in A.5.4 entitled ``Examples of 
scientifically validated test methods.'' In the interest of maintaining 
current protections, as well as being consistent with implementation in 
the EU, germ cell mutagenicity is adopted in the final rule as 
proposed.
    Carcinogenicity. The primary change to the carcinogenicity hazard 
class as proposed in Appendix A, Chapter A.6, ``Carcinogenicity,'' is 
the addition of A.6.4, ``Classification of carcinogenicity.'' In the 
current HCS, carcinogenicity was determined in part by consulting the 
National Toxicology Program's biennial Report on Carcinogens (RoC), or 
the International Agency for Research on Cancer's monographs. In 
addition, chemicals that are regulated by OSHA based on their 
carcinogenicity (i.e., there is a substance-specific standard 
addressing the chemical, and the chemical poses a risk of 
carcinogenicity), are always covered by the HCS. The IARC and NTP 
documents are prepared based on the evaluation of data by experts 
convened by these organizations. A number of commenters suggested that 
this should still be permitted under the GHS-aligned criteria. For 
example, the United Steelworkers argued (Document ID 0403):

    The current Hazard Communication standard includes a reference 
to several lists of chemicals automatically presumed to be 
hazardous, such as the lists of carcinogens published by the 
National Toxicology Program (NTP) and the International Agency for 
Research on Cancer (IARC). The proposal removes references to such 
lists, in favor of a more detailed and complicated classification 
system. While that classification system is required by the GHS, the 
lists provide useful guidance and should not be removed altogether.
    We suggest the following compromise: OSHA should state in the 
regulatory text that a classifier may presume that the presence of a 
chemical on one or more of those lists is sufficient to classify the 
chemical as hazardous with respect to the hazard covered by the 
list. (OSHA should also state that the inverse is not true: The 
absence from a list does not indicate the lack of a hazard.) This 
does not mean that the classifier is required to classify a chemical 
as hazardous based solely on the list, only that he or she is free 
to do so. OSHA should also indicate in the preamble that the Agency 
will use the lists as guidance in enforcement, and that a classifier 
who ignores the lists should be prepared to show why his or her 
judgment is better than the judgment of, for example, NTP or IARC.

Similarly, Morganite Industries, Inc. and Morgan Technical Ceramics, 
stated (Document ID 0321):

    For example, IARC, NTP and other qualified organizations assess 
carcinogenicity and come to published conclusions. We do not 
understand why the proposed Hazard Communication Standard 
establishes procedures for chemical suppliers to conduct such 
assessments, seemingly asking them to conduct their own evaluations 
in the manner

[[Page 17719]]

of similar to these expert agencies. That makes no sense to us. Why 
not just refer to the conclusions published by these agencies? That 
would shorten and simplify the regulation, it would eliminate large 
parts of the difficult language and it would eliminate regulatory 
requirements that are in fact infeasible for most preparers of MSDS 
to comply with.

    OSHA agrees with these commenters that allowing evaluators to rely 
on IARC and NTP could make classification easier for them, as well as 
lead to greater consistency. Therefore, A.6.4.1 has been added to the 
criteria in the final rule to indicate that classifiers may treat these 
sources as establishing that a chemical is a carcinogen without 
applying the criteria themselves. And A.6.4.2 reiterates that OSHA-
regulated carcinogens are covered under the HCS.
    In order to facilitate the use of IARC and NTP determinations as 
sources for purposes of classification, non-mandatory Appendix F has 
been significantly modified. In the NPRM, Appendix F was simply a 
verbatim quote of guidance from IARC on determining carcinogenicity. In 
the final rule, Appendix F has been updated to reflect the latest 
version of that IARC text, but also includes additional guidance on how 
to use IARC and NTP to make carcinogenicity classifications. The 
inclusion of this guidance should make classification easier for 
chemicals addressed by these sources, and should also provide 
parameters for the type of weight-of-evidence decisions that are 
appropriate under the GHS-aligned criteria.
    The following table is included in Part D of Appendix F, and may be 
used to perform hazard classifications for carcinogenicity under the 
HCS. It relates the approximated GHS hazard categories for 
carcinogenicity to the classifications provided by IARC and NTP, as 
described in Parts B and C of Appendix F:

                              Table XIII-2
------------------------------------------------------------------------
    Approximate equivalences among carcinogen classification schemes
-------------------------------------------------------------------------
              IARC                        GHS               NTP RoC
------------------------------------------------------------------------
Group 1.........................  Category 1A.......  Known.
Group 2A........................  Category 1B.......  Reasonably
                                                       Anticipated (See
                                                       Note 1).
Group 2B........................  Category 2 .......
------------------------------------------------------------------------
Note 1:
1. Limited evidence of carcinogenicity from studies in humans
  (corresponding to IARC 2A/GHS 1B);
2. Sufficient evidence of carcinogenicity from studies in experimental
  animals (again, essentially corresponding to IARC 2A/GHS 1B);
3. Less than sufficient evidence of carcinogenicity in humans or
  laboratory animals; however:
a. The agent, substance, or mixture belongs to a well-defined,
  structurally-related class of substances whose members are listed in a
  previous RoC as either ``Known'' or ``Reasonably Anticipated'' to be a
  human carcinogen, or
b. There is convincing relevant information that the agent acts through
  mechanisms indicating it would likely cause cancer in humans.

    While the criteria for carcinogenicity (as well as other health 
effects) are largely based on weight of evidence evaluations, there are 
also provisions in the GHS for countries that want to ensure that all 
potential carcinogens are adequately captured by the criteria. Thus 
paragraph 3.6.2.6 of the GHS chapter on carcinogenicity states:

    * * * For inclusion into Safety Data Sheets, positive results in 
any carcinogenicity study performed according to good scientific 
principles with statistically significant results may be considered.

OSHA chose to include this requirement in Figure A.6.1 of Appendix A in 
the NPRM under Category 2, suspected human carcinogen. Specifically, 
the statement read:

    Positive results in any carcinogenicity study performed 
according to good scientific principles with statistically 
significant results qualifies for referencing the chemical as, at 
the least a Category 2 carcinogen.

    The Styrene Information and Research Council (SIRC) (Document ID 
0361) argues that the ``one positive study'' criterion is 
inconsistent with the weight of evidence approach. In fact, it is not 
part of the weight of evidence approach, but rather reflects the 
Agency's decision to ensure that the current level of protection in 
terms of identifying potential carcinogens in the workplace is 
maintained in the HCS as permitted by the GHS provisions.
    SIRC also indicated that it is not clear what is meant by 
``referencing'' the chemical as, at the least, a Category 2 carcinogen. 
OSHA agrees that the inclusion of this language in Figure A.6.1 is not 
as clear as it could be in terms of what is required. In the final 
rule, OSHA has separated this requirement from Category 2, and added a 
new heading of ``Other considerations'' to the table. The text for the 
``Other considerations'' is: ``Where the weight of evidence for the 
carcinogenicity of a substance does not meet the above criteria, any 
positive study conducted in accordance with established scientific 
principles, and which reports statistically significant findings 
regarding the carcinogenic potential of the substance, must be noted on 
the safety data sheet.'' Categories 1 and 2 will remain based on weight 
of evidence, but the data that meet the definition of ``other 
considerations'' must also be provided on the SDS for the chemical. 
This will maintain the protections of the current rule and provide 
information to downstream users so they can determine the appropriate 
protective measures to be taken in these situations.
    In paragraph A.6.3.2 of the NPRM, OSHA included the mixture 
approach in GHS paragraph 3.6.3.1 regarding use of test data as a whole 
to characterize the carcinogenic potential of a 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.

SIRC (Document ID 0361) similarly took issue with this 
provision:

    Again, the use of the word ``conclusive'' appears to be an 
inappropriate attempt to apply the European Precautionary Principle 
to this issue. It is inconsistent with the fundamental principle 
that hazard communication is to be based on the application of 
expert judgment to known information and not require chemical 
testing (either explicitly or as an inevitable practical requirement 
to avoid unacceptable economic consequences). The word 
``conclusive'' should be replaced with the word ``adequate'' or 
``persuasive.''

The provision in A.6.3.2 recognizes that it is difficult to accurately 
characterize the carcinogenicity of a mixture with an ingredient that 
is clearly carcinogenic. It requires skilled, expert judgment, and test 
results on the mixture as a whole may be misleading. Therefore, the

[[Page 17720]]

experts who developed the carcinogenicity criteria believed that given 
the critical nature of this effect and the known limitations of 
assessing carcinogenic potential in a mixture, it was appropriate to 
allow testing of the mixture as a whole to supersede an evaluation 
based on the carcinogenic potential of a known ingredient only when the 
data allow a sufficient level of confidence about the mixture's 
hazards. OSHA agrees with the findings of these experts, and does not 
believe that the word ``conclusive'' needs to be replaced. This 
provision remains the same in the final rule. It also does not require 
or imply that any testing of chemicals be performed. It is actually 
rather unusual to have mixtures tested for any types of effects, so it 
is expected that this provision will not be applied frequently. If a 
test is performed voluntarily with the purpose of avoiding 
characterization of a mixture as a carcinogen, it is very important 
that the test provide conclusive evidence before depriving downstream 
users of information that ingredients in the mixture present a 
carcinogenicity hazard.
    In addition to the technical considerations, SIRC (Document ID 
0361) (as well as SPI, Document ID 0392), repeatedly 
suggests that the precautionary principle, or European approaches, are 
the genesis of various provisions. First, OSHA does not agree that the 
precautionary principle had any part in the GHS, or the HCS, 
provisions. The HCS is an information transmittal standard, not a 
standard that requires the implementation of controls or other risk 
management approaches. The precautionary principle generally applies to 
competent authorities, and allows them to regulate or establish 
controls in situations where complete information is not available 
about the situation. That certainly does not apply to this provision in 
the HCS, which requires definitive data before allowing a chemical 
manufacturer or importer to designate a mixture as not being 
carcinogenic, although it contains an ingredient that clearly has a 
carcinogenic potential. The HCS is a standard that is intended to 
provide information to users of chemicals so they can make their own 
determinations as to what controls are needed to prevent adverse health 
effects or the effects of physical hazards. The better information they 
have about the chemicals in their workplaces, the more likely they will 
be able to make their own risk assessments, and choose appropriate risk 
management measures. The provisions of the HCS--as well as the GHS--are 
designed to ensure that such information is available to users.
    The criteria proposed are adopted in the final standard, with the 
addition of the paragraphs referring to NTP, IARC, and OSHA-regulated 
substances, and supplemented by the revised non-mandatory Appendix F.
    Reproductive toxicity. This hazard class, described in Appendix A, 
Chapter A.7, was proposed to have two hazard categories (Category 1, 
which is subdivided into two sub-categories based on human evidence, 
and Category 2, which also includes evidence from animal studies). In 
addition, it requires consideration of effects on or via lactation. 
Several commenters argued that OSHA should not adopt effects on or via 
lactation (Document ID 0344, 0351, and 0381). The rationale 
provided is that there is no standard assessment method. However, the 
criteria already recognize that there is no standard assessment method, 
and provide the types of information that can be used to assess whether 
a chemical poses this effect. While such information may not be 
available for many chemicals, there are certain types of products that 
may have such information available, and it is information that needs 
to be provided to exposed workers. Therefore, OSHA is maintaining 
effects on or via lactation in the final rule. In addition, this 
maintains consistency with the EU approach.
    The only change OSHA has made in the final rule is to change 
``should'' to ``shall'' in A.7.2.5.4, since it is mandatory in the HCS. 
Otherwise, the criteria are adopted as proposed in the text of the 
final rule.
    Specific target organ toxicity single exposure (STOT-SE). This 
hazard class, described in Appendix A, Chapter A.8, was proposed to 
have three categories. The first two categories deal with differences 
in the type of evidence available to assess the effect, while the third 
addresses transient target organ effects, such as narcotic effects and 
respiratory irritation. Several commenters indicated that Category 3 
could be adopted without adopting Category 2 (Document ID 
0344, 0351, 0381, and 0393). Procter & Gamble (P&G) (Document 
ID 0381) argues that Category 2 should not be adopted:

    There are also a significant difficulty and potential unintended 
outcome that weigh against applying Category 2. Animal studies may 
be done for a variety of purposes, some of which are not relevant to 
consumer product uses, and the interpretations of animal data from 
these types of studies often yield conclusions not relevant to 
consumer products. Using the outcomes from animal studies for 
classification into Category 2, especially studies at exposures near 
the point of morbidity, requires an unusual level of expertise that 
many classifiers would not possess. In addition, classification into 
Category 2 relies on interpretation of the phrase ``relevant to 
human health,'' which would involve an additional expertise. 
Therefore, Category 2 should not be adopted.

    There are a number of difficulties with this argument. First, this 
section addresses protection of workers exposed to chemicals, and not 
the assessment of consumer products and exposures. Many consumer 
products are not covered by the HCS, although provisions in the scope 
and application cover those products where they are used in the 
workplace in a manner different than consumers would use them, or with 
a more extensive duration and frequency of use.
    In devising the Category 1/Category 2 approach to classifying 
specific target organ toxicity after single (and repeated) exposure, 
the framers of the STOT-SE (and STOT-Repeated Exposure) criteria sought 
to establish a means by which the chemical manufacturers and importers 
could communicate to the worker information as to both the nature and 
the severity of adverse systemic and target organ effects. The final 
rule provides detailed criteria to clarify what would be considered an 
``adverse'' effect (See A.8.2.1.7.3), and it also provides specific 
examples of effects (``changes'') that might be seen in animal studies, 
yet would not be considered to be ``adverse'' (A.8.2.1.8).
    Using these criteria and examples, classifiers will be able to 
consider whether a change was, as required by Category 2, ``of 
relevance for human health.'' In specific cases when an evaluated 
change was deemed not to be relevant, the classifier is allowed to 
discount specific toxicological study findings that are not relevant to 
human hazard assessment and not classify. OSHA believes that 
classification under Category 2 will be no more difficult than other 
hazards under the rule, and that no ``special additional experience'' 
will be needed to classify for Category 2, as suggested by P&G.
    Additionally, the GHS-based STOT criteria proposed for adoption by 
OSHA sought to introduce the concept of dose response to the 
communication of specific target organ toxicity hazards. Such a concept 
has long been part of the assessment of acute toxicity hazards, but has 
been missing from the communication of many other health hazard 
endpoints. Adoption of both Categories 1 and 2, as proposed, allows the 
chemical manufacturer/importer of a chemical to convey to the worker 
additional information as to the

[[Page 17721]]

characterization of the specific target organ hazard by providing some 
general measure of whether an effect (change) might be expected at low 
(presumably occupationally relevant) exposure, or whether it would be 
seen only in cases of unusually high exposure (e.g., catastrophic loss 
of safety controls).
    P&G also suggests that Category 2 is inconsistent with paragraph 
3.8.1.3 of the GHS in that ``it does not rely primarily on human data * 
* *.'' However, while GHS 3.8.1.3 (A.8.1.3 in the final rule) does say 
that human data will be the ``primary source for classification,'' it 
also specifically states that classification in this hazard class may 
also be made on reliable evidence ``in experimental animals, 
toxicologically significant changes * * *.'' Thus, P&G's contention is 
not accurate. In addition, animal data are used or referred to 
throughout the criteria in the GHS for health hazards, and the use of 
such data to predict effects in exposed humans is a standard 
toxicological approach.
    In addition to its appropriateness for protection of workers, 
Category 2 has been adopted by the EU, and adopting it in the final 
rule will thus maintain consistency with the EU as well.
    Aspiration hazard. OSHA did not propose to adopt Category 2 for 
aspiration hazards covered by the GHS. This category appeared 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 ANPR 
commenters agreed that Category 2 should not be covered in the HCS 
(Document ID 0034, 0077, 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 0102, 0104, and 0163).
    Several commenters on the NPRM also argued that aspiration hazard 
should be completely excluded from the revised HCS (See, e.g., Document 
ID 0373, 0393, 0398, 0486, and 0528). In addition, one comment 
suggested that the criteria could be interpreted as applying to 
drowning, and is overbroad (Document ID 0353).
    The primary proponent for complete exclusion of aspiration as a 
hazard in the revised GHS was the Hydrocarbon Solvents Panel (the 
Panel) of the American Chemistry Council. In their post-hearing 
comments, the Panel summarized their position as follows (Document ID 
0528):

    (1) OSHA should not adopt the Aspiration Toxicity class under 
the GHS because, as demonstrated by data submitted to the record, 
aspiration as a route of exposure is not common in the industrial 
setting, and is not a significant cause of occupationally related 
severe or fatal poisonings.
    (2) Should OSHA include Aspiration Toxicity as one of the Health 
Hazard classes, the Panel urged that OSHA not require the Health 
Hazard Symbol be used as part of the pictogram because it does not 
accurately symbolize the nature of the hazard represented by the 
aspiration route of entry, and could be potentially misleading.
    (3) Should OSHA include Aspiration Toxicity and a symbol, the 
Exclamation Mark symbol is more appropriate for the Aspiration 
Hazard Pictogram. Of the existing symbols in the proposed rule, the 
Exclamation Mark symbol is more representative of an actual 
aspiration episode. The Exclamation Mark would be a better choice to 
connote the hazard endpoints and response necessary in an aspiration 
event, due to the immediate need for intervention in an aspiration 
episode.
    (4) If OSHA is unwilling to adopt the Exclamation Mark symbol 
for Aspiration Toxicity, we request that OSHA forward the concern to 
the UNSCEGHS for its consideration.

With regard to the Panel's first point, OSHA agrees that this route of 
exposure is not frequently found in the occupational setting. But that 
is different than saying it does not occur, or should not be a concern. 
NIOSH has submitted a number of studies and reports to the record that 
document concerns about aspiration (Document ID 0523 and 
0524), and address occupational exposures as well (Document ID 
0523). For example:

    Amoruso et al. [2008] reported that aspiration of mineral 
spirits into the lungs may produce serious damage leading to 
bronchopneumonia that may be fatal within 24 h[ours] * * *.
    Rodriguez et al. [1991] reported a case incident where deaths in 
3 crude oil tanker workers were reported as attributed to pulmonary 
aspiration as evidenced by histopathology studies. The hypothesized 
mechanism of deaths included the contributing factors of asphyxia by 
toxic gases leading to loss of consciousness, traumatic injury and 
aspiration.

A number of other cases are described in the NIOSH comment. The Panel 
itself noted two aspiration fatalities in the period from 2003 to 2007, 
one of which was related to a corrosion inhibitor, and the other to 
sodium bisulfate (Document ID 0486, 0494 Tr. 212). Moreover, 
the Panel's chair testified that her company includes aspiration hazard 
warnings on all of its products (Document ID 494 Tr. 214-15). 
Therefore, it is clear to OSHA that there are legitimate concerns about 
aspiration in terms of both occupational injuries and fatalities, and 
that aspiration hazards need to be included in the scope of the HCS. 
Thus, OSHA included Chapter A.10, ``Aspiration Hazard,'' in Appendix A 
in the proposed rule and has retained it in the final rule.
    With regard to the symbol, the application of the more severe 
health hazard symbol to a Category 1 hazard category is consistent with 
how the symbols are applied to all of the health hazards. Adopting the 
exclamation mark in the U.S. for aspiration Category 1 would make the 
HCS inconsistent with other countries' rules regarding aspiration 
hazard, which would present difficulties for countries exporting to the 
U.S., and potentially create inconsistencies in what workers see on 
labels and SDSs. This would not be an effective communication approach 
to aspiration hazards. Therefore, OSHA does not agree that the 
exclamation mark should be permitted for Category 1 aspiration hazards. 
In terms of presenting it to the UN Sub-committee as an issue, OSHA 
will take that suggestion under advisement. However, industry 
stakeholders are free to make this suggestion to the Sub-committee 
themselves through submission of a paper.
    With regard to the contention that drowning in water could 
conceivably be read as being covered by the aspiration hazard criteria, 
OSHA assures stakeholders that drowning in water is not covered and 
that the HCS will not be interpreted as addressing drowning in water as 
an effect covered by the rule.
    Aspiration Hazard, Category 1, is included in the final rule as 
proposed.
    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 current 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 in this rulemaking as DOT has in this rulemaking will 
have

[[Page 17722]]

the additional benefit of accomplishing substantial domestic 
harmonization.
    As with Appendix A and the health hazard criteria, OSHA edited 
Chapter 2 of the GHS (``Physical Hazards'') to shorten the discussions 
and focus only on the criteria in the proposed revisions. Decision 
logics and hazard communication information are not included. As with 
health hazards, OSHA tried 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 adopting 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. The 
current HCS covers flammable liquids in Category 4, and exclusion of 
this category would result in reduced protection, which OSHA does not 
believe is appropriate. Thus Category 4 is included in the revised 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. This 
modification was supported by stakeholders (See, e.g., Document ID 
0362).
    While OSHA believes that harmonizing with DOT provides significant 
benefits, there were some concerns regarding this approach that arose 
in reviewing the physical hazard criteria. These concerns involved 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 invited 
comment on these factors, including comments on the appropriateness of 
the criteria (including the test methods and references to packaging or 
volume) when applied to the workplace, and any suggestions that 
interested parties have to address these issues. Of particular interest 
were criteria for self-reactive chemicals, organic peroxides, self-
heating chemicals, and explosives. Commenters indicated that the 
criteria could be applied to the workplace (See, e.g., Document ID 
0330, 0336, 0383, and 0405). Others specifically noted that 
OSHA should maintain consistency with DOT (See, e.g., Document ID 
0338, 0344, 0351, 0376, 0379, 0381, and 0392). For example, 
the Industry Minerals Association--North America stated (Document ID 
0379):

    The classification, labeling, handling and storage of chemicals 
related to transport concerns should remain aligned with the 
principles of HCS. OSHA should seek where possible to reduce 
incompatibilities between HCS criteria and US DOT transportation 
requirements.

    Accordingly, OSHA has decided to carry through these requirements 
to the final rule as proposed. OSHA is satisfied that, in this respect, 
the criteria proposed are appropriate.
    The Society of the Plastics Industry, Inc. (SPI) (Document ID 
0392) contends that the requirements will not be possible to 
implement for organic peroxides:

    The GHS would require that the SDS for organic peroxide include:
    (1) Recommended use of the chemical and restrictions on use;
    (2) Precautions for safe handling;
    (3) Conditions for safe storage, including any 
incompatibilities, and
    (4) Appropriate engineering controls.
    Compliance with these requirements, which include principles 
from the EU regulation for the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH), presents a 
particular concern for organic peroxide producers following 
transportation and initial storage in the DOT-regulated transport 
container. As written, compliance would present unreasonable 
difficulties and appears to be infeasible for suppliers of these 
chemicals. Customers are likely to handle and use these materials 
under significantly different conditions once they remove the 
organic peroxides from the packages in which they were transported.

SPI further recommends that OSHA require ``that labels and SDSs include 
a generic statement of fact indicating that changes in risk and hazard 
can occur when these self-reactive materials are moved from normal 
transport and storage conditions into process settings, and that they 
may require assessments by specialists.'' SPI also suggests that OSHA 
should be harmonizing with DOT in this area.
    SPI indicates that these requirements for information on SDSs 
originate with REACH requirements in Europe. In fact, OSHA has always 
required such information on SDSs (with the exception of intended use 
of the chemical, and restrictions on use), and these requirements 
preceded REACH by many years--as did the negotiated text of the GHS. In 
Sec.  1910.1200 (g)(2)(viii) and (ix) of the HCS promulgated in 1983, 
the preparer of the MSDS is required to provide any generally 
applicable precautions for safe handling and use, and any generally 
applicable control measures such as engineering controls, which are 
known to the chemical manufacturer, importer or employer. OSHA also 
notes that the manual supplied and written by SPI: ``SAFETY AND 
HANDLING OF ORGANIC PEROXIDES: A Guide'' (dated August 1999), 
recommends that downstream users consult labels and MSDSs for handling 
information (Document ID 0392). OSHA does not agree that the 
SDS requirements in the NPRM, and the final rule, are infeasible or 
even substantially different than what has been required by OSHA since 
1983. The Agency does not agree that the suggested statement should be 
required by OSHA regarding organic peroxides. Chemical manufacturers 
and importers of organic peroxides are free to provide whatever advice 
they deem appropriate in the supplementary information part of the 
label, or on the SDS, to guide downstream users for appropriate 
handling, as long as the advice does not conflict with the required 
hazard communication information.
    With regard to harmonizing with DOT, the criteria in the final rule 
are the criteria that DOT adopted from the UN Transport 
recommendations. Therefore, OSHA is harmonizing with DOT through this 
rulemaking.
    One commenter indicated that there was concern that criteria based 
on transport classification may confuse workplace application, and 
guidance would be needed (Document ID 0339):

    Concerns have been expressed that the criteria developed for 
transport concerns, as stated in the GHS, express very specific 
constraints, or ``worse case scenarios'', which can be confusing to 
suppliers and users of chemicals who are reading the Safety Data 
Sheets (SDSs)/labels, etc., without benefit of the context. PRR 
believes this is an area in which OSHA could develop informational 
materials to help chemical suppliers and users understand the 
rationale behind physical hazard classifications.

OSHA will keep this suggestion in mind as guidance materials are 
developed.
    Only minor editorial revisions have been made to Appendix B after 
reviewing all of the comments received. While a great number of changes 
were suggested by one commenter (Document ID 0353), most have 
not been adopted, consistent with the discussion above on

[[Page 17723]]

the background for Appendixes A and B. This approach is to maintain 
consistency with the GHS and DOT, as well as the EU.
    The modifications made in the final rule include changing metric 
references to units used in the U.S., and modifying references to 
documents incorporated by reference to make them consistent with OSHA's 
requirements for such references. There are no technical changes to the 
criteria. Therefore, Appendix B in the final rule is substantially the 
same as proposed.
Classification Database
    One interesting comment that was submitted by a number of 
respondents to the ANPR involved development of a classification 
database (Document ID 0047, 0050, 0053, 0054, 0038, 0155, 
0160, and 0165). Opinions as to who would develop and maintain such a 
database varied (OSHA, U.S. industry, and an international body were 
all mentioned). It appears that the European Union will be making such 
a database available for compliance with its requirements, as have 
Japan, Taiwan, South Korea, and New Zealand. Concerns have been raised 
by stakeholders that classifications in these databases are different 
for the same chemical. OSHA invited additional comment on this issue in 
the NPRM (74 FR 50284, Sept. 30, 2009), and received a number of 
responses.
    Many supported the concept of having such a database (Document ID 
0328, 0329, 0330, 0335, 0336, 0339, 0341, 0352, 0365, 0366, 
0379, 0383, 0389, 0408, 0410, and 0453). There were also various 
comments about how a database might be done. Some thought OSHA should 
do the classifications and maintain them online, or that the 
classifications should be considered ``official'' (Document ID 
0330, 0341, and 0453). Others were concerned about the 
Agency's ability to develop and maintain a database (Document ID 
0339), or said it should only be done if resources were 
provided to maintain it (Document ID 0365). Alternatively, 
resources could be provided for classifiers to help improve the quality 
of their classifications (Document ID 0365).
    Others suggested that NIOSH could be tasked with developing and 
maintaining the database (Document ID 0341 and 0408). NIOSH 
commented that funding is not currently available, and that OSHA may 
wish to partner with the EU database efforts (Document ID 
0412). Additionally, NIOSH and another commenter (Document ID 
0383) suggested alternatives to developing a database using 
existing information such as the Department of Homeland Security's 
database; using International Chemical Safety Cards that currently 
cover 1,650 substances and are translated into many languages; or 
adding GHS classifications to the National Library of Medicine, 
including its Hazardous Substances Data Bank. NIOSH is also updating 
its Pocket Guide to include GHS classifications.
    Another suggestion was to have the UN develop a database so there 
is a globally harmonized list, and the Department of Labor could help 
support it (Document ID 0328 and 0335). The National Fire 
Protection Association (NFPA) (Document ID 0366) suggested 
that its database of 2,500 chemicals could be useful in the transition. 
Other commenters suggested that suppliers can provide classifications 
to a central repository (Document ID 0352, 0408, and 0410), 
but one commenter warned that if left to manufacturers, there would be 
differences that would have to be resolved downstream (Document ID 
0328). Another comment raised a concern that, while a common 
database might be useful, it could also interfere with weight-of-
evidence determinations (Document ID 0379). However, such a 
database could prove useful for substances, which would provide the 
basis for mixture classifications (Document ID 0335).
    Other commenters did not support having a classification database 
(Document ID 0324, 0344, 0351, 0370, and 0377), or indicated 
that if OSHA were to develop a classification list, it should be non-
binding guidance, and include stakeholder input and global 
accessibility (Document ID 0344, 0381, 0393, and 0405). Others 
were concerned that a common database would create another unharmonized 
list of classifications compared to lists in other countries (Document 
ID 0344), and that manufacturers should have the 
responsibility for classification (Document ID 0324 and 0405). 
Also, a company could have valid data that contradicts a classification 
assigned in a database, and should be allowed to use its own 
information (Document ID 0351). There was also a concern that 
such a list might impede progress by not using the best available data 
(Document ID 0377). Another commenter argued that the database 
would need to be internationally developed and maintained to be useful, 
which would result in the elimination of national or regional lists 
(Document ID 0376).
    OSHA is very interested in whether an international database of 
classifications could be developed and maintained. It is not likely to 
be feasible for OSHA to develop and maintain a U.S.-based database, 
which, as some have noted, would be less useful than an internationally 
harmonized approach that preempts countries and regions from developing 
their own approaches. The subject has been raised and discussed in the 
UN Sub-committee, and a correspondence group has been established to 
explore the issue further. OSHA has volunteered to lead that group and 
to help form a consensus position in the Sub-committee on options to 
address this issue. In the meantime, some of the suggested sources can 
provide extensive information to assist businesses with GHS 
classifications, particularly small businesses with fewer technical 
resources. The International Chemical Safety Cards--which are linked on 
both OSHA and NIOSH Web pages--are one such resource. The OECD has also 
established a global chemical portal that includes extensive 
information on chemicals (www.oecd.org/ehs/eChemPortal).
    (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 in paragraph 
(e) are intended to ensure that hazard communication in a given 
workplace is coordinated and comprehensive. An employer's program must 
include a list of the hazardous chemicals known to be present in the 
workplace (paragraph (e)(1)(i)). This list is basically an inventory of 
the chemicals the employer must have safety data sheets for, and must 
be available 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 must be kept by an ``identity'' of the chemicals (which 
will be the ``product identifier'' under the final 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.
    The employer's hazard communication program must also include how 
the standard's requirements for labels, SDSs, and training will be met 
(paragraph (e)(1)); how the hazards of non-routine tasks will be 
addressed (paragraph (e)(1)(ii)); and how hazard communication will be

[[Page 17724]]

handled in a multi-employer workplace situation (paragraph (e)(2)). 
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 it should have enough detail to 
provide the reader with a blueprint of the workplace-specific program.
    Several comments to the ANPR 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 0022, 
0027, 0111, and 0164). Revising the chemical inventory was cited by 
these commenters as one aspect that was likely to be burdensome. Since 
the chemical inventory is basically a list of the products an employer 
has in the workplace that are considered hazardous, the only way this 
list would change as a result of implementing the GHS would be if 
something that was not hazardous before is now, or vice versa. OSHA 
believes that this is not a significant concern for three reasons. 
First, it would be unusual for a chemical to only have one hazardous 
effect associated with it so that the overall determination of hazard 
would be affected by a change in classification in one hazard class. 
Second, 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 paragraph (b) (Scope and 
application), OSHA does not believe that the scope of hazards covered 
by the final rule is substantially different than the current HCS.
    The most likely differences resulting from re-classification under 
the final rule are 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 an employer's program, it does not 
appear likely there would be many, if any at all. Written hazard 
communication programs usually include provisions 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 final HCS 
will not affect those provisions. OSHA does not believe that extensive 
revisions would have to be made to written programs, including the 
inventory, under the final rule.
    OSHA did not propose any substantive modifications to the written 
hazard communication program, and it does not anticipate any 
significant new burdens associated with revising the program as a 
result of other modifications in the final rule.
    While the written hazard communication program was mentioned 
several times in relation to the costs of compliance, or the burdens on 
small businesses, it was generally not discussed in a substantive way 
by rulemaking participants. The Building and Construction Trades 
Department of the AFL-CIO (Document ID 0359) expressed 
concerns about the challenges associated with implementation of the HCS 
on multi-employer worksites, a subject that is addressed in the written 
hazard communication program requirements. They suggested that the 
controlling employer on a site coordinate hazard communication 
activities. This is not a subject related to adopting the GHS, and no 
changes are being made to the rule to address it. The written program 
must address how the exchange of information will be accomplished, and 
that will continue under the final rule.
    (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 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 current 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.)''
    The current HCS similarly requires identity and appropriate hazard 
warnings for in-plant containers. 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 the current standard 
allows employers to continue to use 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

[[Page 17725]]

not. Large manufacturers have frequently developed their own libraries 
or repositories of standard phrases, with decision logics for when to 
apply them to convey a hazard or a precaution. Therefore, not only does 
this approach lead to labels that are different, it also results in a 
large duplication of effort by chemical manufacturers developing their 
own systems.
    This performance-oriented approach also did not lend itself to 
harmonization. Other countries often use more specific approaches, 
including assignment of standard phrases to certain hazardous effects, 
symbols, and other label elements. It was clear that the performance 
orientation of HCS, with its many acceptable varieties of labels, could 
not be standardized through agreement on content to achieve 
harmonization.
    Given that a more specified approach would also lead to consistency 
among manufacturers, as well as helping to ensure the same message is 
received by all exposed employees, OSHA agreed to negotiate a 
harmonized approach that was more specific than the current standard. 
This was also agreed to by stakeholder representatives involved in the 
negotiations. Thus once a chemical is classified as to its hazard 
classes and corresponding categories, the GHS specifies exactly what 
information is to appear on a label for that chemical. As described in 
Part IV 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.
    The NPRM proposed more modifications for paragraph (f) than most of 
the other paragraphs of the existing standard. It changed the title of 
paragraph (f)(1) to indicate it addresses labels on shipped containers. 
OSHA also proposed adding a number of new types of information to the 
label: 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. One commenter (Document ID 0520) proposed a 
different format for the requirements in paragraph (f). While OSHA 
appreciates the suggestion, the format followed by OSHA is dictated to 
a large extent by document drafting requirements of the Federal 
Register, and remains the same in the final rule. Commenters suggested 
that OSHA add the words ``where specified'' to paragraph (f)(1) because 
there are a few hazard categories that do not require all of the 
elements listed (for example, there may be no symbol required for the 
category (Document ID 0344, 0381, 0381, and 0393)). However, 
this concern is addressed in paragraph (f)(2), which states that the 
information has to be consistent with Appendix C. Therefore, the change 
has not been made. There was also a suggestion that the language in 
(f)(1) conflicts with the definition of label (Document ID 
0353). OSHA reviewed both the paragraph language and the 
definition, and does not agree. Therefore, this change has not been 
made.
    The final rule requires that labels on shipped containers contain 
much more information than required by 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 final 
rule, 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 final rule refer to this as 
supplemental information. Several commenters requested that this be 
permitted (Document ID 0132 and 0145). As has already been 
discussed above with regard to the definitions for hazard statements 
and precautionary statements, such additional information is permitted 
in Appendix C of the rule as long as it is accurate and does not 
conflict with the required label elements. Paragraph (f)(1) is adopted 
in the final rule as proposed except to provide clarity in light of 
OSHA deleting the requirement for labeling for hazards not otherwise 
classified. OSHA has modified paragraph (f)(1) to explicitly state that 
hazards not otherwise classified do not have to be addressed on 
container labels. Paragraph (f)(1) in this final rule now requires that 
chemical manufacturers, importers, or distributors ensure that each 
container of hazardous chemical leaving the workplace is labeled, 
tagged, or marked. Hazards not otherwise classified do not have to be 
addressed on the container. The paragraph also includes the information 
that the chemical manufacturer or importer must provide on the label, 
tag, or mark.
    Paragraph (f)(2) of the proposal addressed labeling for 
unclassified hazards. As noted in the discussion on definitions, this 
has been changed to Hazards Not Otherwise Classified in the final rule. 
In addition to the change in the definition, OSHA has removed the 
proposed requirement for labeling unclassified hazards. Since there are 
no label elements in the rule to address these hazards, the Agency 
decided to cover them in a more limited fashion, and removed the 
requirement for labeling them from the final rule. Hazards not 
otherwise classified will still be addressed on the SDS.
    Paragraph (f)(3) in the proposal elaborated the label requirements 
by stating that the required information would 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. Since paragraph (f)(2) of 
the proposal has been deleted from the final standard, paragraph (f)(3) 
of the proposal is now paragraph (f)(2) in the final rule. Each of the 
subsequent paragraph numbers have changed accordingly. New paragraph 
(f)(2) also requires that the label be prominently displayed, and in 
English (although other languages may also be included).
    New paragraph (f)(3) requires the harmonized information to be 
located together on the label, tag, or mark. This paragraph has been 
adopted in the final standard as it was proposed.
    The rest of paragraph (f) in the current standard remained largely 
the same in the proposed modified text, although conforming changes to 
terminology were made throughout the paragraph. The current standard's 
accommodation for labels associated with solid metal was maintained in 
the revised text, although OSHA has added a heading of ``Solid 
materials'' to it. The provision regarding conflicts with the 
requirements of DOT has also been maintained. 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 ANPR commenters 
specifically noted that OSHA should avoid conflict with DOT (Document 
ID 0064 and 0066). This is already addressed in paragraph 
(f)(5) in the final standard. NPRM commenters further noted that the 
exterior package should be for displaying DOT labels, rather than for 
OSHA labels (Document ID 0345). In general, this would be

[[Page 17726]]

true, although there are some cases where the single 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 set forth in Appendix C of the final 
standard.
    The American Trucking Association (ATA) also raised the issue as to 
whether a GHS-compliant label might lead to a carrier's violation under 
DOT based on the carrier's ``constructive knowledge'' that a shipment 
contains a hazardous material (Document ID 0345). ATA 
suggested that OSHA and DOT need to work together to address this 
issue. OSHA contacted DOT and was told that this issue is addressed in 
49 CFR 172.401, Prohibited Labeling. Specifically, GHS labels are 
exempted under 49 CFR 172.401(c)(5).
    Under proposed paragraph (f)(7) (paragraph (f)(6) in the final 
rule), OSHA addressed workplace labeling. As noted previously, the 
current standard provides employers with flexibility regarding the type 
of system to be used in their workplaces. Some ANPR comments suggested 
that OSHA maintain this flexibility in the proposed standard (See, 
e.g., Document ID 0047, 0145, and 0157). OSHA agrees, and the 
final rule retains the 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 for workplace 
containers, the information supplied must be consistent with the 
revised HCS. Hazard classifications must be revised as necessary to 
conform with the final rule, and the other information provided must be 
revised accordingly to ensure the appropriate message is conveyed. 
Final paragraph (f)(7) remains the same as proposed.
    OSHA did not propose 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 work shift, 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.
    The only one of these provisions that received significant comment 
was the one regarding updating of label information within three months 
of receiving new and significant information regarding the hazards of a 
chemical. This provision ((f)(11) in the final rule) has been in the 
HCS since the 1994 revisions, but an administrative stay was placed on 
it shortly after it was promulgated in response to manufacturers' 
concerns. That administrative stay was never reconsidered or removed by 
OSHA, so the provision was not enforced. OSHA noted in the NPRM (74 FR 
50283, Sept. 30, 2009) its intent to lift the stay, and requested 
comment and input on whether the time frame is appropriate. It should 
also be noted that an administrative stay is a tool available to OSHA 
to cease enforcement for reasons the Agency finds appropriate. It is 
not, as some appeared to assume, something that is adjudicated by an 
outside body, nor does it involve publication or documentation based on 
any type of record. It is usually a short-term solution to a problem 
that can be resolved through discussions with affected parties.
    The current HCS requires that SDSs be updated within three months 
of learning of significant new hazard information, and that requirement 
has been enforced since the standard first went into effect in 1983. 29 
CFR 1910.1200(g)(5). It is important to ensure that labels are 
similarly updated in a timely fashion, particularly since they provide 
the most immediate information in the workplace.
    It appears that some commenters thought this provision was the 
effective date for updating the labels with the new GHS-aligned 
provisions (Document ID 0400, 0502, and 0513). This is not the 
case. Paragraph (j) of the final rule gives a much longer time period 
to implement the new GHS label requirements. Paragraph (f)(11), by 
contrast, addresses situations when a label must be changed because 
there is new and significant information about the hazards of the 
chemical. For example, there may be new studies that indicate an 
ingredient of the product is a potential carcinogen. This happens 
infrequently, so it is not anticipated that this provision would apply 
in many cases.
    The key concern of commenters is what to do about stockpiles of 
chemicals that are already labeled. As noted by one commenter (Document 
ID 0370), new technology is available that links labels and 
SDSs, making new label generation more efficient. Stockpiles and 
distribution are now managed through computer programs that were not 
widely available in 1983. These programs can affect the amount of 
product kept in stockpiles, as well as the distribution of products in 
the supply chain, and thus the ability to deal with this updating 
issue. Consequently, a number of participants agreed that three months 
was an acceptable time frame (Document ID 0330, 0335, 0336, 
0339, 0349, 0351, 0370, 0383, 0408, and 0410). Other commenters 
suggested that it was reasonable to allow sales to continue of products 
that are already labeled (Document ID 0313, 0323, 0327, 0328, 
0329, 0344, 0351, 0361, 0375, 0377, 0381, 0399, and 0410). For example, 
Ecolab (Document ID 0351) stated:

    Ecolab agrees that three months for labels to be updated with 
significant changes to the hazards is acceptable. However, it would 
also be reasonable to allow the sell-through of product that is 
already produced and labeled. By three months, we agree new 
production of that product should occur with the significant new 
information, as long as existing date-coded inventory can be sold 
without modification. * * *

    Others thought the administrative stay should be continued 
(Document ID 0353 and 0405). Of those who suggested 
alternative time frames, a number thought twelve months would be 
appropriate (Document ID 0328, 0352, 0372, 0376, 0382, 0399, 
0402, and 0405). Others indicated three months was not enough (Document 
ID 0379); updating at some time interval is needed (Document 
ID 0365); six months would be the minimum (Document ID 
0324, 0344, and 0361); or a range of six or seven to twelve 
months would be appropriate (Document ID 0411).
    The North American Insulation Manufacturers Association (NAIMA) 
detailed some of the factors that influence the ability of a 
manufacturer to update a label: (1) Identification of the products 
whose labels need to be changed; (2) drafting new label language, which 
might require redesign of the packaging; (3) the ability to obtain new 
label or packing stock for printing; (4) the availability of printers 
to print the new material within the required time; (5) and 
transportation time for stock to the printer, from the printer to the 
manufacturer, and from the manufacturer through the supply chain 
(Document ID 411). NAIMA argues that many of these factors may 
be beyond the control of the manufacturer.
    OSHA will not maintain the stay. It is necessary that labels be 
updated to

[[Page 17727]]

ensure that users have the appropriate information in a timely manner. 
OSHA is also not convinced that any difficulties in updating labels 
justify a full year's delay in providing significant new information. 
However, OSHA is persuaded that, in some cases at least, it may be 
difficult to update labels within three months. Thus, final paragraph 
(f)(11) allows six months to begin labeling shipped containers with the 
new information. As noted above, there are few situations where this 
provision will come into play. It is not related to every modification 
of the label, just those that are significant with regard to hazard 
information. Six months should be long enough to revise labels, and 
allow for the depletion of already labeled product. While some 
commenters discussed the need for global compliance associated with 
different labels (Document ID 0376), OSHA is only requiring 
domestic compliance within this time frame. Therefore, the provision is 
adopted in the final rule with a six-month time period for updating 
product labels when there is new and significant information about the 
hazards.
    One commenter suggested that OSHA add a new requirement that 
importers, distributors, and employers inform the chemical manufacturer 
in writing, within three months, when they become aware of significant 
information about the hazards of a chemical (unless they have already 
received this information from the chemical manufacturer) (Document ID 
0520). The HCS has always been designed on the premise that 
the chemical manufacturer is in the best position to know what 
information is available about the chemicals produced. This information 
is then to be disseminated downstream to distributors and users of the 
chemical. This suggestion would create a very extensive new burden on 
parties in the distribution chain who are not responsible for the 
chemical or the information regarding it as required under the GHS. It 
is not consistent with the approach in the rule, and is not the most 
effective and efficient way to identify and distribute information. 
Therefore, OSHA rejects this suggestion. However, downstream users are 
free to inform manufacturers of new hazards of which they learn, and 
OSHA encourages the sharing of such information.
    A few commenters on the ANPR also argued that a small package 
exemption, or some type of prioritization of information on small 
packages, should be permitted (Document ID 0043, 0046, and 
0080). The current HCS does not have such an exemption or limitation, 
but the Agency has allowed practical accommodations in enforcement 
policies for those situations where an issue has occurred. (See, e.g., 
CPL 02-02-038'' Inspection Procedures for the Hazard Communication 
Standard: ``CSHOs must consider alternate labeling provisions (for 
example, tags or markings) for containers which are of unusual shape or 
proportion and do not easily accommodate a legible label.'')
    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 did not propose 
to adopt such a provision, and has retained its current approach 
regarding small packages in the final rule. Very small packages 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.
    Following the NPRM, further comments were received on the issue of 
labeling small packages. Some suggested that OSHA should provide clear 
guidance for small containers, including perhaps a suggested priority 
for the label information (Document ID 0313, 0327, and 0339). 
Others thought the manufacturer should be permitted to pick the most 
important hazard and precautionary statements to include on small 
packages (Document ID 0405), or that OSHA should use the GHS 
guidance on the issue (Document ID 0342). Particular problems 
were noted, such as labeling small containers for reference standards 
(Document ID 0342). Phylmar Regulatory Roundtable testified 
during the hearing, and suggested that OSHA should either establish a 
priority for information on a small package label, or clarify what is 
meant by practical accommodations (Document ID 0497 Tr. 113).
    The guidance in the GHS (1.4.10.5.4.4) basically allows countries 
to introduce a consideration of risk by determining that small 
quantities of the chemical are not a concern, or that information may 
be omitted because of the small volume. This approach is not consistent 
with the HCS, or with the concept of right-to-know. It is also 
unacceptable to OSHA to allow manufacturers to decide which information 
is the most important. Essentially, all of the suggested solutions 
result in less information being available to exposed employees than 
other employees would receive when exposed to the same chemical 
packaged in a larger container.
    The concept of practical accommodations is difficult to define, 
since it entails a judgment by OSHA staff when confronted with the 
details of a specific situation. The point, however, is to find a way 
to provide the required information in every situation, and not to 
start with the premise that the solution is to omit such information. 
Ensuring that workers receive the required information may be 
accomplished in ways other than simply attaching it directly to each 
small container. OSHA will examine the situation to make sure that the 
information is associated with the proper containers, and that it is 
complete. OSHA is not adopting any regulatory requirements for small 
packages, but will consider whether any additional guidance is needed 
as the standard is implemented.
    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. At least one commenter noted that the GHS 
does not specify a location or size of core information on a shipment 
(Document ID 0066). OSHA believes that the performance-
oriented approach of paragraphs (f)(3) and (f)(10) is preferable. The 
Agency will allow accommodations to be made as long as the information 
is located together, and is prominently displayed as required.
    A number of commenters endorsed the overall approach or specific 
parts of the label requirements. Comments included adopting the GHS 
labels (Document ID 0324 and 0339), supporting the flexibility 
of the in-plant labeling (Document ID 0392), and the use of 
signal words (Document ID 0321). Others wanted to ensure that 
hazards are conveyed accurately to all levels of education in the work 
force (Document ID 0331); supported allowing other languages 
on labels (Document ID 0381); suggested OSHA should allow 
flexibility of format and placement of required label elements 
(Document ID 0405); and suggested that OSHA should follow 
Revision 3 of the GHS for label requirements (Document ID 
0382). OSHA believes that the final standard incorporates all 
of these concepts.
    Appendix C details how the specified label elements apply to each 
hazard class and hazard category. OSHA has made some modifications to 
the

[[Page 17728]]

introductory text to Appendix C regarding the combination of hazard and 
precautionary statements, and these modifications were discussed under 
paragraph (c), Definitions. Comments received regarding red border 
frames for pictograms, and making the precautionary statements 
mandatory, are also discussed above in the explanation of paragraph 
(c), Definitions. Also, as discussed in the explanation of that 
paragraph, OSHA has added definitions to the final standard for simple 
asphyxiant and pyrophoric gas. The Agency has also added a new section 
to Appendix C to provide the label elements for these hazards (C.4.30, 
Label Elements for OSHA Defined Hazards).
    In C.2.1, ``Precedence of hazard information,'' addressing 
precedence of symbols, OSHA indicated that where the skull and 
crossbones is on a label, the exclamation point should not be included 
for acute toxicity. In the GHS, the statement simply says the 
exclamation point should not be included where the skull and crossbones 
is on the label. This is followed in the GHS by two other statements 
about not using the exclamation point for specific hazards when there 
is already a symbol for the more severe category of the same hazard. 
OSHA received a comment that the phrase ``where it is used for acute 
toxicity'' should be deleted since it is not in the GHS (Document ID 
0393). OSHA believes that this phrase is appropriate for 
clarity and parallel construction with the other provisions of the 
paragraph. The skull and crossbones symbol only addresses acute 
toxicity, and does not convey other types of effects.
    One commenter indicated that paragraph C.2.3.3 should not be 
mandatory (Document ID 0335). The paragraph indicates that 
when there is a DOT pictogram for a hazard on a label, an additional 
GHS pictogram for the same hazard must not appear. The reason it is 
mandatory is that having two different pictograms addressing the same 
hazard may lead to confusion for people handling the chemical.
    OSHA also indicated that it was proposing to exclude ammunition and 
ammunition components under Division 1.4S from having the exploding 
bomb symbol and precautionary statements normally used for explosives 
(74 FR 50283, Sept. 30, 2009). This proposed exclusion was based on 
discussions during OSHA's rulemaking to update the explosives standard, 
and the issue of ammunition being sold in retail establishments. The 
Agency asked for input on whether the exclusion of the symbol was 
sufficiently protective, and whether any adjustments needed to be made. 
Several people thought the symbol should be included on ammunition and 
components since they are explosive (Document ID 0313, 0327, 
and 0328). However, others thought it was appropriate to treat 
ammunition and components differently, and that the exploding bomb does 
not represent the hazards of ammunition (Document ID 0330, 
0336, 0338, 0370, and 0376). OSHA agrees with these commenters that the 
exploding bomb does not represent the hazards of ammunition, implying 
that there is a mass explosion hazard when handling these items, 
although that is not the case. Therefore, the Agency is maintaining the 
proposed provisions in the final standard, and will not be requiring a 
symbol or precautionary statements for ammunition and ammunition 
components.
    A question was raised by the National Propane Gas Association 
(Document ID 0400) regarding signal words for propane if both 
simple asphyxiant and flammability hazards are covered since they have 
different signal words (warning and danger, respectively). Appendix C 
explains the precedence rules for signal words. Only one is ever 
required on a label. If one of the hazards warrants a ``danger'' signal 
word, then that will be the only one required on the label.
    A few comments were also received about the interface of the new 
OSHA label requirements with the requirements of other agencies. For 
example, it was noted that it would be difficult to use one label to 
comply with both OSHA and CPSC (Document ID 0405), and that 
EPA and CPSC should accept GHS labels until they adopt the system 
themselves (Document ID 0328). OSHA does not have authority to 
determine the policies of other agencies with regard to accepting the 
new GHS-aligned labels. Another commenter noted that fireworks are 
regulated by other agencies, and therefore additional requirements are 
burdensome (Document ID 0355). The new OSHA requirements will 
be essentially harmonized with DOT's requirements, which will 
facilitate compliance with both agencies. Lastly, it was noted that 
OSHA should coordinate label implementation with Canada's Workplace 
Hazardous Material Information System (WHMIS) (Document ID 
0461). As was noted earlier, OSHA does have bilateral 
discussions with Canada on implementation issues--however, Canada has 
not yet adopted the GHS or initiated implementation by regulation.
    (g) Safety data sheets. The proposed revisions to this paragraph 
were 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, it was 
largely based on the positions of 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 a uniform order of information or a format. In particular, 
stakeholders such as emergency responders were concerned that 
information not being located 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 
voluntary industry consensus standard that included a 16-section SDS 
(ANSI Z400, Hazardous Industrial Chemicals--Material Safety Data 
Sheets--Preparation). This consensus standard establishes the titles of 
each section and the order of presentation. It addresses 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. ANSI Z400 also responded to 
comments indicating that 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 by having sections for each of those categories of 
information.
    In 1990, OSHA published a Request for Information (RFI) that 
addressed the issues of comprehensibility of labels and SDSs (55 FR 
20580, May 17, 1990). Nearly 600 comments were 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

[[Page 17729]]

requirements. However, through interpretation, OSHA has made clear for 
many years that the ANSI format is acceptable, as long as the SDS 
includes the required information (See CPL 02-02-038, ``Inspection 
Procedures for the Hazard Communication Standard'' (Mar. 20, 1998), the 
compliance directive for the HCS). As explained in Section IV 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 
Labour 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 so that hazard information comes before the chemical 
names of ingredients. This change has subsequently been adopted by ANSI 
and other groups to be consistent with the GHS.
    Since the 16-section SDS was initiated in the U.S. by industry, 
many companies have been using it. This adoption by industry will 
reduce the impact of the harmonized GHS requirements. Others who 
continued to use different formats will need to change their SDSs to 
conform. There is already software available to assist in developing 
SDSs in the 16-section format, and it is expected that more tools will 
be available as the dates for SDS compliance approach.
    OSHA proposed 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 was proposed to be 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 and the NPRM, sections 12 through 15 
of the SDS require information on subjects that are 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 final rule, like 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 (completion of all sections of the SDS; 
provisions for complex mixtures; the requirement for information to be 
accurate and reflect the scientific evidence; the need to update the 
SDS when new and significant information is available; maintenance of 
SDSs so they are accessible to employees; accommodations for situations 
where employees travel between workplaces during a work shift; and 
access for OSHA and NIOSH) remain in this final standard as they are in 
the current standard, although they have been re-numbered.
    As was the case with labels, relatively few comments were submitted 
in response to the ANPR or the NPRM on the specific provisions for 
SDSs. The final provisions are generally consistent with the current 
HCS, with the exception of the standardized approach described above 
that OSHA proposed and adopted in the final rule.
    The only text changes that were made to the provisions that follow 
(g)(2) in the standard were to revise the terminology to be consistent 
with the new approach. However, there were some editorial suggestions 
for other changes (Document ID 0353). Consistent with OSHA's 
stated intent to not change anything that does not require change to 
align with the GHS, these suggestions have not been implemented in the 
final rule.
    A number of rulemaking participants stated that they support the 
standardization of SDSs, and some noted that standardization would 
facilitate training (Document ID 0307, 0321, 0322, 0349, 0456, 
and 0463). It was suggested that OSHA update (g)(8) to (g)(10) to 
indicate that electronic distribution is acceptable (Document ID 
0376 and 0395). It is already stated in (g)(8) that electronic 
access is acceptable for employees (although OSHA has removed 
``microfiche'' from this provision since that technology is outdated 
and rarely used and in any event is captured under the broader term 
``other alternatives,'' which is retained in the final rule). 
Electronic distribution is not precluded, although the employer on the 
receiving end of the information must be able to access it in that 
form. The general issue of electronic distribution and access is 
addressed in the compliance directive for the standard (CPL 02-02.038), 
and is based on recommendations made by the National Advisory Committee 
on Occupational Safety and Health (NACOSH). As explained in the 
directive, electronic distribution is permitted, but the 
appropriateness of its implementation will be judged as follows:

    MSDSs must be readily accessible and there must be no barriers 
to employee access during the work shift. The Agency interprets the 
term ``readily accessible'' to mean immediate access to MSDSs. The 
employer has flexibility to determine how this will be accomplished. 
The use of electronic means such as computers with printers, 
microfiche machines, the Internet, CD-ROMS, fax machines, etc., is 
acceptable. Employers using electronic means to supply MSDSs to 
their employees must ensure that reliable devices are readily 
accessible in the workplace at all times; that workers are trained 
in the use of these devices, including specific software; that there 
is an adequate back-up system for rapid access to MSDSs in the event 
of an emergency, including power outages, equipment, and on-line 
access delays; and that the system is part of the overall hazard 
communication program of the workplace. Additionally, employees must 
be able to access hard copies of the MSDSs, and in the event of 
medical emergencies, employers must be able to immediately provide 
copies of MSDSs to medical personnel. Mere transmission of the 
requested information orally via telephone is not acceptable.
    Employers may use off-site MSDS management services to meet the 
requirements of the HCS only if MSDSs are readily available to 
employees, either as hard copies in the workplace or through 
electronic means and as long as the provisions outlined

[[Page 17730]]

in the previous paragraph are ensured. Despite the use of an MSDS 
management service, the employer maintains primary responsibility 
for the hazard communication program, including receipt and use of 
the information to develop and implement a site-specific hazard 
communication program under paragraph (e) of the HCS.
    When immediate access to paper or hard copy MSDSs does not 
exist, CSHOs should evaluate the performance of the employer's 
system by requesting a specific MSDS. Ultimately, the evaluation of 
an adequate system will rely on the professional judgment of the 
CSHO. Factors that may be appropriate to consider when determining 
if MSDSs are readily accessible include:
    (1) Are the sheets or alternative methods maintained at a 
location and under conditions where employees can access them during 
each work shift, when they are in their work areas?
    (2) If an electronic system is used for MSDS access (computer, 
fax, etc.) do employees know how to operate and obtain information 
from the system? (CSHOs should request an employee to retrieve MSDSs 
using the electronic system.)
    (3) Was there an emergency/accident where immediate access was 
critical?
    (4) How quickly did the employer respond to the employee's 
request?
    Employees must have immediate access to MSDSs and be able to get 
information when they need it in order for an employer to be in 
compliance.
    On multi-employer job sites, employers who produce, use or store 
hazardous chemicals in such a way that other employers' employees 
are exposed or potentially exposed, must communicate to other 
employers how the means of access to MSDSs will be accomplished.

    Various suggestions were made for improvements to SDSs. For 
example, it was suggested that the SDS be limited to five pages 
(Document ID 0415); that a one-page, eighth-grade reading 
level summary of its contents should be provided (Document ID 
0306); and that SDSs be written in plain and simple language 
(Document ID 0347). OSHA agrees that SDS preparers should try 
to ensure the SDSs are written clearly, and preparers should consider 
the audience in determining how the information may be best 
communicated. 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, and addresses information that 
exposed workers are most likely to need (summary of hazards 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. It is difficult to regulate those 
aspects of preparing documents that are intended to convey technical 
information, and no specific requirements of this type have been 
included in the final standard.
    There was also a comment that the Superfund Amendments and 
Reauthorization Act (SARA) refers to material safety data sheets (See 
42 U.S.C. 11022), and that changing the name to safety data sheets 
would violate the Paperwork Reduction Act (PRA)(Document ID 
0350). Changing the references to the data sheet does not 
violate PRA or SARA. As is clear from the foregoing discussion, MSDSs 
under the current standard and SDSs under the final rule both serve the 
same function and communicate the same types of information. OSHA 
believes that an SDS under the final rule should be treated as an MSDS 
under SARA, but if the regulated community needs additional clarity, it 
can ask EPA to issue an interpretation to ensure there are no 
compliance issues. Similarly, because the change of the regulatory term 
from material safety data sheet to safety data sheet does not, by 
itself, create a paperwork burden, there are no PRA implications.
    One commenter suggested that OSHA add to the SDS the date the 
chemical was produced, where chemical testing occurred to determine SDS 
data, and the manufacturer's Web site (Document ID 0346). OSHA 
rejects this suggestion, noting that the final rule does not require 
adding information to the SDS that would make it significantly 
different from the GHS harmonized information requirements. 
Furthermore, it would not be practical to require either the date the 
chemical was produced (which would result in a costly requirement to 
revise SDSs for every day the chemical was produced), or where chemical 
testing occurred (which may not be known, given that such information 
is obtained from many different sources, and studies do not frequently 
indicate where the testing occurred). However, suppliers are free to 
provide this information on their Web sites, and often do.
    In the NPRM, OSHA noted that mixture safety data sheets could no 
longer be prepared by attaching multiple SDSs for the ingredients, but 
rather would have to be an SDS for the mixture as a whole (74 FR 50392, 
Sept. 30, 2009). One commenter (Document ID 0334) thought the 
multiple SDSs practice should continue to be allowed, particularly to 
minimize burdens for small businesses. OSHA believes that this approach 
is not in compliance with the GHS-aligned requirements. It also does 
not provide the best information for those downstream, including small 
business users.
    New mandatory Appendix D, ``Safety Data Sheets,'' provides 
additional requirements for the information to be included under each 
section heading. The sub-headings used to indicate the additional 
information were lettered (e.g., (a) product identifier used on the 
label, (b) Other means of identification, and so forth). Questions were 
raised as to whether the letters identifying each subheading were 
considered mandatory (Document ID 0382, 0376, and 0393). 
Apparently, the EU requires the subheadings to be numbered. OSHA does 
not consider the letters to be mandatory, but the information each 
subheading identifies is required to be included. A similar comment 
indicated that the format of Section 9, Physical and chemical 
properties should be clarified (Document ID 0339). No 
particular format is required. Appendix D simply requires that 
information responsive to that heading and its subheadings must be 
included. If applicable information is not available, the SDS must 
state so.
    Another commenter indicated concern that Appendix D does not refer 
to ANSI Z400.1 or Annex 4 of the GHS (Document ID 0336). OSHA 
does not believe that reference to either of these documents is 
necessary since Appendix D is self-contained. As Appendix D is 
mandatory, those documents would have to be incorporated by reference 
to be referred to, and that is not necessary for purposes of compliance 
with the standard. However, both ANSI Z400.1 and Annex 4 would be 
useful references for SDS preparers since they provide additional 
guidance for completing an SDS.
    In the final rule, a small modification has been made to the 
introduction to Appendix D to indicate that a subheading ``within a 
section'' needs to be marked when no relevant information is available. 
Also, OSHA has added column identifiers of ``heading'' and ``sub-
heading'' to clarify what is being referred to by that terminology.
    Additional comments were received on specific sections of the SDS. 
For example, in section 1, ``Identification,'' the American Chemistry 
Council wanted clarification of subheading (c), ``Recommended use of 
the chemical and restrictions on use'' (Document ID 0393). As 
explained in Annex 4 of the GHS, A4.3.1.3, the SDS preparer should 
``provide the recommended or intended use of the substance or mixture,

[[Page 17731]]

including a brief description of what it actually does, e.g., flame 
retardant, anti-oxidant, etc. Restrictions on use should, as far as 
possible, be stated including non-statutory recommendations by the 
supplier.'' Section 1 is adopted in the final rule as proposed.
    On Section 2 of the SDS, ``Hazard identification,'' the Soap and 
Detergent Association argued that the requirement for precautionary 
statements in subheading (b) should not be included because they are 
not mandatory in the GHS (Document ID 0344). However, the GHS 
requires that precautionary statements appear on a label 
(1.4.10.5.2(c)), and Annex 4 (A.4.3.2.2) indicates that the GHS label 
elements, including precautionary statements, should be included in 
Section 2 of the SDS. As has already been discussed, OSHA is adopting 
the GHS precautionary statements, so they are mandatory for purposes of 
complying with this standard.
    Other commenters questioned what was meant by ``unknown toxicity'' 
in Section 2, subheading (d) (Document ID 0367 and 0371). This 
term refers to the criteria for determining the acute toxicity of a 
mixture where there are ingredients that have no available acute 
toxicity data. In this case, the percentage of ingredients that have no 
data to consider in the calculations must be indicated in Section 2. In 
the final rule, OSHA has slightly modified sub-heading (d) to clarify 
this reference.
    In addition to this clarification, two other changes have been made 
in Section 2. First, references to paragraphs (d) and (f) said 
``paragraph (d)[(f)] of this section,'' which is the normal regulatory 
reference since the entire standard is called a ``section'' of the Code 
of Federal Regulations. However, since parts of the SDS under the 
``Headings'' column are also referred to as sections, it was confusing. 
Section 2 now refers to the section number of the standard, 1910.1200. 
This change is tracked in other parts of Appendix D as well. Second, 
subheading (c) has been revised to refer to hazards not otherwise 
classified, rather than unclassified hazards, consistent with 
modifications to the regulatory text.
    In Section 3, ``Composition/information on ingredients,'' 
commenters indicated that OSHA had left out a phrase that appears in 
the GHS with regard to identification of ingredients in a mixture 
(Document ID 0344 and 0393). This was an oversight, and OSHA 
has added the language ``and are present above their concentration 
limits/cut-off levels'' into Section 3. To ensure consistency with the 
classification criteria, OSHA has also clarified that ingredients that 
present a health risk below the cut-off/concentration limits would also 
need to be disclosed in section 3 of the SDS. It was also suggested 
that where the SDS discloses only the range of concentrations, the 
narrowest range possible should be permitted (Document ID 
0395). Neither the GHS provisions for information on SDSs, nor 
the guidance for completing them, address specific limits for 
concentration limits. Under the current rule, concentrations of 
chemicals in a mixture are not required to be disclosed at all. OSHA 
agrees with the commenter that when SDS preparers use ranges rather 
than a specific percentage composition, the range must be limited in 
terms of the percentage concentration variation, and the variation in 
concentration must have no effect on the hazard of the mixture.
    In order to help ensure that use of concentration ranges is 
understood, OSHA has added the term ``concentration'' in parentheses 
after the ``exact percentage'' terminology used in paragraph (i)(1) 
regarding trade secret protection. Similarly, the term ``exact 
percentage'' has been added in parentheses after ``concentration'' in 
Section 3 requirements for the SDS. These terms refer to situations 
where the mixture has a set formula, and the amount of a substance in 
the mixture is consistent from batch-to-batch. OSHA recognizes that 
there are some very small variances in this situation that have no 
impact on the hazard of the overall mixture. ``Exact percentage'' is 
the terminology used in the GHS guidance for preparation of SDSs, but 
these small variations or tolerances are expected and acceptable when 
reporting the anticipated percentage based on the formula.
    Concentration ranges, rather than concentrations, may be used in 
other situations. For example, the final standard includes the 
longstanding provision that addresses the use of a single SDS for 
complex mixtures in paragraph (g)(4). Under this provision, where 
complex mixtures have similar hazards and contents (the ingredients are 
essentially the same, but the specific composition varies from mixture 
to mixture), one SDS may be used for all of these similar mixtures. 
Petroleum streams would be an example of a type of complex mixture to 
which this provision applies. In this situation, concentration ranges 
may be used for the ingredients that vary from stream to stream.
    A chemical manufacturer or importer may also have a line of 
products that are very similar, but can be varied slightly in 
composition to meet the needs of customers. For example, toner colors 
may be changed by varying the amount of pigment. The variances are 
small, and the hazard remains the same. In these situations, 
concentration ranges may be used for multiple, similar products.
    Trade secret status may be claimed for exact percentage composition 
but not for concentration ranges. Where a trade secret claim is made 
for exact percentage, the chemical manufacturer or importer may choose 
to provide a concentration range to assist downstream users in 
providing appropriate protections and, at the same time, potentially 
eliminating requests from users for disclosure of the trade secret in 
accordance with Sec.  1910.1200. However, Section 3 must indicate that 
a trade secret claim is being made and information has been withheld.
    Section 8 addresses exposure controls and personal protection. Some 
commenters noted that the information provided should have more detail 
than what was proposed in Appendix D, such as requiring information on 
specific PPE materials that provide protection (Document ID 
0359 and 0456). OSHA agrees that SDS preparers should provide 
the most specific information available for the material so that the 
appropriate protective measures can be implemented. Annex 4 of the GHS, 
guidance for preparing the SDS, addresses the specific type of 
information on personal protective equipment that should be provided in 
Section 8 of the SDS in paragraph A4.3.8.3. OSHA will be making 
additional guidance available when the rule is implemented.
    Section 8 also addresses inclusion of occupational exposure limits 
(OELs) on the SDS. Comments were received on inclusion of exposure 
limits on SDSs in response to the ANPR, and a number of different 
opinions were expressed, particularly regarding TLVs being required. 
Many ANPR commenters argued that TLVs should be included on the SDSs, 
as is currently required under the HCS (See, e.g., Document ID 
0042, 0179, 0021, 0038, 0124, and 0149). Others suggested they 
should not be required (See, e.g., Document ID 0036, 0058, 
0064, 0129, 0151, and 0163). A number of commenters 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., Document ID 0018, 0024, 0109, 0147, and 0171).
    In the NPRM, OSHA proposed to maintain the requirement to include 
its mandatory permissible exposure limits

[[Page 17732]]

(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 would 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. OSHA requested comment on this approach, and received many 
opinions from rulemaking participants.
    First, many people agreed that the PEL should be on the SDS 
(although some acknowledged that they are out-of-date) (See, e.g., 
Document ID 0328, 0330, 0332, 0336, 0338, 0339, 0340, 0341, 
0344, 0349, 0351, 0352, 0354, 0357, 0359, 0375, 0379, 0382, 0399, 0412, 
and 0414). For example, the American Foundry Society (Document ID 
0375) supported including the PEL, but thought other limits 
should only be included at the discretion of the SDS preparer:

    Our industry generally supports the requirement to include OSHA 
PELs, but not require the other recommended limits on SDSs. In 
particular, the American Conference of Industrial Hygienists 
(ACGIH)--TLVs, while able to provide useful information often lack 
credibility. As the result of a sometimes flawed development 
process, the TLVs can be misleading and their use can reduce clarity 
of communication. For certain materials, some manufacturers may 
choose to include TLVs on an SDS, or include other non-mandatory 
exposure values, including their own recommendations, but this 
should not be mandatory. The relevance of such other non-mandatory 
guidelines should be determined by the manufacturer who can best 
explain the meaning, context and limitations of such values.

    Others specifically supported the approach proposed (See, e.g., 
Document ID 0351, 0366, 0370, 0376, 0381, 0383, 0393, 0408, 
and 0411). Clariant Corporation (Document ID 0383) indicated 
they would support the proposed text, as well as a non-mandatory 
appendix listing other exposure limits:

    Clariant supports the recommendation to ``include other 
occupational exposure limits used or recommended''. Clariant would 
also support a non-mandatory appendix to the HCS to include 
reference to the TLVs and other occupational exposure limits such as 
the AIHA WEELs. Many companies already include other occupational 
exposure limits on their SDS. In most cases, those other limits are 
more up-to-date than the OSHA PELs.

The American Industrial Hygiene Association (AIHA) also suggested 
inclusion of a non-mandatory appendix listing other exposure limits 
such as the TLVs and WEELs (Document ID 0365).
    Many commenters supported mandatory disclosure of applicable TLVs 
on the SDS in Section 8 (See, e.g., Document ID 0313, 0315, 
0317, 0319, 0323, 0327, 0328, 0330, 0332, 0336, 0340, 0347, 0349, 0353, 
0354, 0357, 0359, 0401, 0403, 0410, 0412, 0413, 0414, 0463, and 0464). 
Others argued that inclusion of the TLVs would be inappropriate because 
such inclusion does not meet the Information (or Data) Quality Act, the 
development process is flawed, or they are non-governmental (See, e.g., 
Document ID 0325, 0375, 0379, 0408, and 0409).
    For example, the Center for Regulatory Effectiveness argued that 
OSHA's decision to require the disclosure of ACGIH TLVs on SDSs is 
inconsistent with the requirements of the Information Quality Act, 
Public Law 106-554, Sec.  1(a)(3), Title V, Sec.  515, 114 Stat. 2763 
(2000). That act required OMB and DOL to issue guidelines ``ensuring 
and maximizing the quality, objectivity, utility, and integrity of 
information * * * disseminated by the agency.'' 44 U.S.C. 3516, note, 
at (b)(2)(A). Both OMB and DOL have issued such guidelines, and in 
addition OMB issued the ``Peer Review Bulletin,'' citing the authority 
of the Information Quality Act. OMB, Guidelines for Ensuring and 
Maximizing the Quality, Objectivity, Utility, and Integrity of 
Information Disseminated by Federal Agencies, 67 FR 8452 (Feb. 22, 
2002) (hereafter ``OMB Guidelines''); DOL, Guidelines for Ensuring and 
Maximizing the Quality, Objectivity, Utility, and Integrity of 
Information Disseminated by the Department of Labor (Oct. 1, 2002), 
found at http://www.dol.gov/cio/programs/infoguidelines/informationqualitytext.htm (hereafter ``DOL Guidelines''); OMB, Final 
Information Quality Bulletin for Peer Review, 70 FR 2664 (Jan. 14, 
2005) (hereafter ``Peer Review Bulletin''). Each of these guidelines 
specifies certain steps an agency should take when engaged in the 
``dissemination'' of ``information.'' OSHA does not believe that it is 
disseminating ``information,'' as defined by these documents, in 
requiring disclosure of TLVs on SDSs.
    All three documents except from the definition of information 
``opinions, where the agency's presentation makes it clear that what is 
being offered is someone's opinion rather than fact or the agency's 
views.'' (OMB Guidelines V.5; DOL Guidelines at 5, 13-14; Peer Review 
Bulletin I.5.) OSHA understands this to mean that the guidelines do not 
apply unless the public could reasonably understand the information 
being disseminated as the official view of the agency. This 
understanding is supported by a number of statements by OMB and DOL. In 
the preamble to the Peer Review Bulletin, for example, OMB states that 
``[a]n information product is not covered by the Bulletin unless it 
represents an official view of one or more departments or agencies of 
the federal government.'' 70 FR at 2667/2. Likewise, DOL's guidelines 
do not apply to information ``clearly represented as opinion and not an 
official agency or Departmental representation.'' DOL Guidelines at 3. 
Hyperlinks on an agency's Web site to information on non-governmental 
Web sites are not an agency dissemination of information, nor is a 
private researcher's publication and communication of the results of a 
government-funded study, where an appropriate disclaimer appears. OMB 
Guidelines V.5; 67 FR 8454/1; DOL Guidelines at 5, 13-14.
    Users of hazardous chemicals could not reasonably think that ACGIH 
TLVs listed on an SDS are OSHA's dissemination of information as to the 
correct or feasible level of exposure to the chemical. As explained on 
the ACGIH Web site, TLVs are the ACGIH's statements of ``scientific 
opinion'' (Document ID 0529). The SDS is prepared by the 
manufacturer and represents the manufacturer's understanding of the 
hazards of the chemical, the appropriate conditions of use, and the 
necessary protective measures to be employed. It is hard to see, in 
that context, how a user of the SDS could understand that the TLVs 
listed on the SDS represent information disseminated by OSHA. The TLV 
will be identified as such on the SDS. Indeed, in the many cases where 
there is an applicable OSHA PEL, the PEL will also be listed in 
addition to the TLV.
    Further, if TLVs are ``information'' for purposes of the IQA, then 
so too is everything in the SDS. If that were true, it would render the 
approach of the HCS unworkable because it would require OSHA to review 
and approve every manufacturer's label and SDS. OSHA does not believe 
Congress intended such a result in enacting the IQA.
    The Center for Regulatory Effectiveness and the AFL-CIO's Building 
and Construction Trades Department suggested that OSHA could

[[Page 17733]]

require SDS preparers to add a statement to the SDS saying that the TLV 
does not represent OSHA's view of a safe level (Document ID 
0325 and 0644). OSHA has decided against such an approach. 
First, as explained above, OSHA does not believe that a reasonable SDS 
user would understand the TLV to be OSHA's official representation. 
Second, such a disclaimer could cause confusion, creating the incorrect 
impression that the remainder of the information on the SDS does 
represent OSHA's official representation about the hazards of the 
chemical in question.
    There are other reasons the IQA guidelines do not apply here. The 
OMB and DOL guidelines only apply to information ``first disseminated 
after October 1, 2002'' (OMB Guidelines III.4; DOL Guidelines at 2), 
and OSHA has required TLVs to be disclosed on MSDSs since 1983. 
Moreover, the guidelines are ``not intended to impose any binding 
requirements on DOL or the public or * * * to provide any right to 
judicial review'' (DOL Guidelines at 2). Rather, ``information quality 
[is] an important management objective.'' (Id.) Courts have accordingly 
rejected private attempts to force agency compliance with the data 
quality guidelines. See, e.g., Salt Institute v. Leavitt, 440 F.3d 156, 
159 (4th Cir. 2006) (IQA ``does not create a legal right to access to 
information or to correctness''); Single Stick, Inc. v. Johanns, 601 F. 
Supp. 2d 307, 316 (D.D.C. 2009) (same), aff'd in relevant part on other 
grounds sub nom Prime Time Int'l Co. v. Vilsack, 599 F.3d 678, 686 
(D.C. Cir. 2010). Likewise, the Peer Review Bulletin is ``intended to 
improve the internal management of the executive branch, and is not 
intended to, and does not, create any right or benefit, substantive or 
procedural'' enforceable against the federal government (Peer Review 
Bulletin XII). OSHA finds that the DOL and OMB Guidelines and the Peer 
Review Bulletin do not require the Agency to take the additional step 
of analysis before requiring the disclosure of TLVs on safety data 
sheets.
    At least one commenter suggested that requiring disclosure of the 
TLV would violate the Administrative Procedure Act's notice and comment 
requirements, to the extent that the SDSs were required to disclose 
TLVs that the ACGIH might adopt after the final rule is published 
(Document ID 0361). That contention was rejected in National 
Ass'n of Manufacturers v. OSHA, 485 F.3d 1201, 1204 (D.C. Cir. 2007), 
where the court held that the hazard communication standard does not 
prescribe particular chemicals for which hazard communications are 
required, but rather a system by which manufacturers and the ACGIH 
evaluate and communicate chemical hazards. This system is not changed 
when the ACGIH modifies a TLV, and therefore no new notice and comment 
is required. Id. Nor is OSHA impermissibly delegating its authority to 
the ACGIH by requiring that TLVs be listed, as argued by the National 
Association of Home Builders (Document ID 0372). The Third 
Circuit rejected that argument in a challenge to the current standard, 
which also required that manufacturers and importers perform hazard 
determinations for all chemicals for which the ACGIH had published 
TLVs. Associated Builders and Contractors v. Brock, 862 F.2d 63, 68 (3d 
Cir. 1988). The final rule's requirement to list nonbinding TLVs is an 
a fortiori case.
    Finally, a number of commenters expressed concerns about the 
procedures ACGIH uses in adopting TLVs (Document ID 0083, 
0084, 0361, 0371, 0372, and 0529). Typical of these is the comment from 
the Independent Lubricant Manufacturers Association:

    TLVs are developed by way of ACGIH committees that operate in 
secret with anonymous authors. Though the opportunity to provide 
written comments exists, there is no ``appeal'' process to 
challenge, question or even engage in a professional discourse with 
the people responsible for developing and finalizing the TLVs. ILMA 
believes that because the TLV development process is closed, TLVs 
have compromised scientific value and limited utility in addressing 
occupational health and safety matters. Indeed, this non-consensus 
process can generate defective decisions that have the potential to 
compromise the health and safety of the very workers the TLVs are 
designed to help. In addition to issues of transparency and 
fairness, TLVs are developed without any regard to the economic and 
technical feasibility of its recommendations or the availability of 
acceptable methods to determine compliance.

(Document ID 0371 (emphasis in original)). Other commenters 
also objected to the fact that the ACGIH provides no public hearing, 
that the extent of review ACGIH committees devote to TLV 
recommendations before adopting them is unclear, and that TLVs are not 
``consensus standards'' within the meaning of the OSH Act (Document ID 
0372 and 0529).
    As explained on its Web site, ACGIH TLVs ``represent conditions 
under which ACGIH believes that nearly all workers may be repeatedly 
exposed without adverse health effects. They are not fine lines between 
safe and dangerous exposures'' (Document ID 0529). TLVs are to 
be used by industrial hygienists in determining safe exposures in 
workplace, according to the ACGIH, but ``are only one of multiple 
factors to be considered in evaluating specific workplace situations 
and conditions.'' (Id.)
    The record evidence shows that the ACGIH uses a reliable and open 
method to develop TLVs with ample opportunity for public input. ACGIH 
TLVs are set by the Threshold Limit Value Chemical Substances Committee 
(Document ID 0536). Members of this committee are chosen for 
their expertise in industrial hygiene, occupational medicine, 
epidemiology, toxicology, or related fields such as statistics or 
chemistry, and members are selected to maintain a balance between these 
specialties. (Id.) Membership preference is given, among other things, 
to those with 10 or more years experience and advanced degrees within 
their field. (Id.) A majority of committee members must be ``Regular'' 
ACGIH members, that is, those occupational hygiene, occupational 
health, environmental health, or safety professionals whose primary 
employment is with a government agency or an educational institution. 
(Id.; See also http://www.acgih.org/Members/memdescrip.htm.)
    The ACGIH has a conflict of interest policy, requiring that members 
disclose, both orally and in writing, ``potential, real, or perceived 
conflict[s] of interest'' with respect to a substance under 
consideration (Document ID 0536). The Committee chair is 
required to conduct a conflict of interest presentation annually, and 
Sub-committee chairs will typically inquire at the beginning of 
meetings as to whether members' conflict status has changed. (Id.) 
Where conflicts arise, the steps to be taken--such as recusal, 
abstention, or disclosure--are decided based on the nature of the 
conflict involved. (Id.)
    Once the relevant ACGIH sub-committee decides to consider a new 
TLV, it is included on an ``Under Study'' list that the ACGIH publishes 
each February 1. (Id.) Each July 31, that list is updated to indicate 
the substances for which the ACGIH anticipates issuing a ``Notice of 
Intended Change'' in the coming year. (Id.) An author is assigned to 
prepare a draft ``documentation'' supporting a proposed new TLV; the 
author or ACGIH staff must conduct a full literature search on the 
substance; and only published, peer-reviewed data may be relied upon in 
the documentation. (Id.) The ACGIH has detailed guidelines governing 
the content of documentations and the method of conducting literature 
searches. (Id.) Once the draft documentation is approved by a sub-

[[Page 17734]]

committee (by consensus) and the full TLV committee, ACGIH issues a 
public Notice of Intended Change and makes the draft documentation 
available to the public for at least a year to submit comments. (Id.)
    The author and the sub-committee review the public comments 
received, and the draft documentation is amended if necessary. (Id.) 
Once the sub-committee reaches consensus, the draft documentation is 
forwarded to the full committee with a proposal to (1) retain the 
current TLV and publish the draft documentation for comment for an 
additional year; (2) change the TLV but publish the draft documentation 
for comment for an additional year; (3) adopt the proposed TLV and 
draft documentation; or (4) withdraw the proposal. (Id.) The proposal 
is then voted on by the full committee, and then the committee's 
recommendation is sent to the ACGIH board of directors for 
``ratification.'' (Id.) Generally ACGIH does not hold meetings with 
interested parties during this process, but its rules allow for public 
discussion of the evidence on a chemical's hazard at ACGIH-sponsored 
symposia, and allows for meetings where new evidence has been developed 
and is ``essential to the Committee's deliberations.'' (Id.)
    NIOSH, the Kentucky Labor Cabinet, the American Industrial Hygiene 
Association, the American Society of Safety Engineers, the Alliance of 
Hazardous Materials Professionals, and several occupational safety and 
health consulting firms support the TLV requirement, stating that ACGIH 
TLVs are useful in developing health and safety programs and are widely 
used in industry (Document ID 0313, 0323, 0327, 0336, 0354, 
0365, 0410, 0412, 0496, and 0521). A number of manufacturers and 
manufacturer associations also support the TLV requirement (Document ID 
0328, 0330, 0332, 0353, 0413, and 495). The International 
Chemical Safety Cards, prepared under the auspices of the UN, list TLVs 
(Document ID 0497). TLVs are currently required to be 
disclosed under the HCS, and witnesses testified that failure to 
include TLVs on SDSs in the final rule would render the standard less 
protective of worker health because TLVs are more up to date and cover 
more substances than OSHA's PELs (Document ID 494 Tr. 28-29, 
94; Document ID 496 Tr. 368, 382).
    Based on this record, OSHA finds that commenters' objections to 
TLVs are without merit. TLVs are set through an open process with ample 
opportunity for public input through the comment and symposium process; 
the fact that the ACGIH does not hold public hearings on proposed TLVs 
does not undermine the fairness of the process. While OSHA agrees that 
TLVs do not address feasibility concerns, it finds that TLVs are useful 
information for employers and employees to use in evaluating the 
hazards presented by chemicals used in their workplaces. OSHA finds 
that the record does not support the contention that TLVs have 
``compromised scientific value'' because of the process used by the 
ACGIH. Each TLV is supported by a documentation explaining the evidence 
and assumptions on which it relies; these documentations are subjected 
to public comment and approved at several levels within the 
organization. It is certainly possible that a manufacturer or importer 
might disagree with the scientific judgments embodied in a TLV, but the 
final rule allows them to set forth their own recommendations about an 
appropriate exposure level on the SDS. Based on the ACGIH's procedures 
and the evidence of TLV use by industry, occupational safety and health 
professionals, and NIOSH, OSHA reaffirms its position that, in general, 
TLVs provide useful information that should be disclosed to employers 
and employees using hazardous chemicals.
    Some commenters supported requiring other limits to be on the SDS 
in addition to the TLVs, such as the NIOSH Recommended Exposure Limits 
(RELs); the AIHA Workplace Environmental Exposure Limits (WEELs); and 
the German maximum allowable concentrations (MAKs) (See, e.g., Document 
ID 0323, 0330, 0336, 0340, 0349, 0354, 0357, 0359, 0401, 0410, 
0412, and 0414). NIOSH recommended broad inclusion of available 
occupational exposure limits (Document ID 0412):

    Providing occupational exposure limits (OELs) helps workers and 
employers understand the relationship between exposure concentration 
and adverse health effects. NIOSH supports the requirement of 
including PELs on the SDSs and further suggests that OSHA consider 
adding additional exposure limits, whenever available, such as NIOSH 
recommended exposure limits (RELs), American Conference of 
Governmental Industrial Hygienists (ACGIH) Threshold Limit Values 
(TLVs), American Industrial Hygiene Association (AIHA) Workplace 
Environmental Exposure Limits (WEELs), and German maximum allowable 
concentrations (MAKs) * * *.

    There were a number of other comments on the issue of exposure 
limits in Section 8 of the SDSs, such as asking for an explanation of 
``any other exposure limit used or recommended'' by the SDS preparer 
(Document ID 0329, 0351, 0382, 0381, and 0393), including 
whether this means exposure limits from other countries. There was also 
a suggestion to delete ``used or'' from the requirement (Document ID 
0339). This language is in the current HCS, and is intended to 
include any exposure limits developed by the producer to protect their 
own employees, as well as other exposure limits commonly available such 
as the TLV or REL. It may also include exposure limits from other 
countries, but there is no intent to require that every known exposure 
limit in the world be provided. OSHA does not agree that it is 
appropriate to delete ``used or'' since companies often have exposure 
limits to protect their own employees, and this information can help 
their customers to determine what is needed to protect downstream 
employees as well. Others thought inclusion of exposure limits in 
addition to the PELs would confuse small businesses (Document ID 
0372), or be detrimental to harmonization (Document ID 
0464).
    The AFL-CIO summarized their view of the record on this issue, as 
well as that of other worker representatives, in their post-hearing 
brief (Document ID 0645):

    We believe that OSHA needs to issue a final rule that restores 
the requirement to list the TLV on the SDS and strong record 
evidence supports our position. There is broad support for this 
position, covering a wide range of organizations including NIOSH 
(Ex. 0412.1) unions (AFL-CIO, Ex. 340.1; Building and Construction 
Trades Department, Ex. 0359.1; and the Steelworkers, Ex. 0403.2); 
safety and health professional associations (American Society of 
Safety Engineers, Ex. 0336.1); employers and their representatives 
(Dow Chemical Company, Ex. 03353.1); Patton Boggs, Ex. 0413.1); and 
individual experts (Adam Finkel, Ex. 0401.1; Harry Ettinger, Ex. 
0319.1).

    In Section 8 of the SDS in the final rule, OSHA has included the 
language used in the current rule to describe what exposure limits are 
to be addressed: ``OSHA permissible exposure limit (PEL), American 
Conference of Governmental Industrial Hygienists (ACGIH) Threshold 
Limit Value (TLV), and any other exposure limit used or recommended by 
the chemical manufacturer, importer, or employer preparing the safety 
data sheet, where available.''
    As noted in the NPRM, OSHA took the reference to TLVs out of 
Section 8 of the SDS in the interest of limiting country-specific 
deviations from the GHS. However, based on many comments in the record, 
OSHA has concluded that the TLVs provide useful information for those 
designing

[[Page 17735]]

protection programs for employees exposed to the chemicals involved, 
and are already widely used and applied for that purpose in American 
workplaces, as well as around the world. Referencing TLVs on the SDSs 
does not make them mandatory or establish them as control guidelines. 
It simply provides additional information that can help employers 
determine the proper levels of protections in their workplaces.
    With regard to the recommendations for other exposure limits to be 
included on the SDS, OSHA agrees that referring to those exposure 
limits could also be useful, and would encourage SDS preparers to 
include them where available. However, the Agency is still concerned 
about including additional country-specific deviations, especially for 
limits that are less available than the TLVs. Providing too many 
different exposure limits may also be confusing to employers. 
Publication of a non-mandatory appendix would require OSHA to 
continually update it, as these different lists are prepared by various 
organizations. Since the Code of Federal Regulations is only updated 
annually, the Appendix would always be out-of-date. We do not believe 
this would be helpful in the long term, and that resources would be 
better put to other purposes than updating a non-mandatory appendix.
    In the NPRM, OSHA did not propose to continue to require specific 
mention of IARC, NTP, and OSHA as sources of determinations regarding 
carcinogenicity. The requirement to consider these sources definitive 
in terms of a carcinogen determination was not included in the NPRM 
since it was not part of the GHS approach. However, as was discussed 
above, OSHA has modified Appendix F to allow classifiers to use these 
sources when assessing carcinogenicity, rather than applying the 
criteria to the data themselves. In order to facilitate this, OSHA has 
provided a table in Appendix F that aligns the GHS criteria with those 
of IARC and NTP. In addition, OSHA has decided to retain the 
requirement to include this information on the SDS in Section 11. This 
information will be of use to classifiers, as well as to employers and 
employees, when ascertaining potential hazards and determining 
appropriate control measures. This was supported by some commenters 
(See, e.g., Document ID 0321, 0335, and 0403), while others 
argued that the determinations of such organizations should not be 
included because of issues with their process of making determinations 
(See, e.g., Document ID 0379, 0417, and 0529). OSHA believes 
that this information from organizations that are recognized as expert 
in the field of carcinogenicity will continue to be helpful to both 
classifiers and users of chemicals, and does not agree with the 
commenters who argue about the process followed to make such 
determinations. The arguments were similar to those discussed above 
regarding inclusion of TLVs on SDSs, and OSHA's response to such 
arguments apply here as well. OSHA finds that both IARC and NTP use 
reliable procedures and criteria in making their determinations.
    OSHA indicated in the NPRM that Sections 12 through 15 of the SDS 
were not going to be mandatory since they involved information that is 
outside OSHA's jurisdiction. With regard to Section 12 on environmental 
effects, some commenters expressed concern about the lack of 
harmonization with trading partners on environmental issues, or 
suggested that OSHA should work with EPA on this issue (See, e.g., 
Document ID 0351 and 0377). OSHA and EPA have discussed this 
issue, and EPA's Office of Chemical Safety and Pollution Prevention 
will be updating applicable Toxic Substances Control Act (TSCA) 
regulations consistent with modifications made in this Federal Register 
Notice. Dates will be published in the Unified Regulatory Agenda 
(www.reginfo.gov). As noted previously, OSHA encourages SDS preparers 
to complete Section 12, as well as Sections 13 through 15, so as to 
have an SDS that is compatible with other international requirements, 
as well as ensuring customers have complete information.
    Similarly, comment was received suggesting that Section 14 on 
transport information should be required, and producers should indicate 
whether the product is, or is not, covered by DOT's Hazardous Material 
Regulations (Document ID 0345). While OSHA does not have 
authority to require this to be included in Section 14, we certainly 
agree that it would be useful information for users of the chemical, 
and encourage producers to complete Section 14.
    In the final rule, non-mandatory Section 15 of the SDS is intended 
to provide other regulatory information. OSHA raised as an issue for 
comment whether this section should be made mandatory by requiring 
regulatory information on OSHA's substance-specific standards be 
included in it. Employers can, of course, voluntarily list information 
about other OSHA standards (Document ID 0376), but voluntarily 
provided information is not subject to enforcement. Many of the 
respondents commented that Section 15 should not be made mandatory 
(See, e.g., Document ID 0324, 0335, 0344, 0352, 0353, 0355, 
0370, 0372, 0376, 0377, 0379, 0381, 0385, 0393, 0399, 0402, 0405, and 
0408). Some questioned whether information about substance-specific 
standards would be useful to users of the SDS (See, e.g., Document ID 
0329, 0335, 0372, and 0405). Others thought that OSHA should 
require the substance-specific standards to be indicated, and that 
Section 15 should thus be mandatory (See, e.g., Document ID 
0328, 0330, 0336, 0338, 0339, 0340, 0347, 0349, 0351, 0354, 
0357, 0365, 0383, 0389, 0403, 0410, 0414, and 0453).
    While OSHA agrees that there is merit in including the substance-
specific standards in Section 15 to inform chemical users of their 
existence and applicability, it is difficult to make completion of 
Section 15 mandatory since there is likely to be considerable other 
information in the section that would not be enforceable by OSHA. 
Having a section that includes both mandatory and non-mandatory 
information is potentially confusing to the regulated community. 
Additionally, the PELs will already be indicated in Section 8, and will 
thus inform the user when there is a substance-specific standard of 
concern. Therefore, while OSHA encourages additional information in 
Section 15, it remains non-mandatory in the final rule.
    One suggestion received for Section 16 indicated that the preparer 
should identify the exact changes made to the SDS when revising it so 
the user can determine if re-training is needed (Document ID 
0469). Presumably, the user would review the changes to decide 
whether re-training is needed. However, the success of such an approach 
would depend on how often the chemical is purchased, and a new SDS is 
received. If the chemical has not been purchased for a while, and a new 
SDS only indicates what changes have been made since the last update, 
the user could have missed versions of the SDS in the interim, and thus 
would not know all of the changes that had been made since the last SDS 
was received. In addition, adding such a requirement would make the 
OSHA provisions internationally inconsistent.
    (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

[[Page 17736]]

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, and to address 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 IV 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 proposed 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 
training on the program has always been required in the HCS, OSHA 
believed that modifying the text slightly would 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. The final 
rule requires that training include 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.
    OSHA proposed 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.
    Some commenters to the ANPR 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 0153 and 0178). 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 0030, 0042, 0072, and 0077).
    Marshfield Clinic (Document ID 0028) noted that 
communication of information about chemicals and other hazardous 
substances:

    * * * is 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: ``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 0065 and 0078). Another noted 
that the current approach is fine for companies that are domestic only 
(Document ID 0026).
    The majority of the comments made on the training provisions 
suggested additions to the existing requirements to further specify 
what is expected, and to improve the training. These comments were 
submitted primarily by worker representatives, or by the National 
Institute of Environmental Health Sciences (NIEHS) (See, e.g., Document 
ID 0340, 0347, 0349, 0357, and 0403). For example, the 
Communication Workers of America (CWA) (Document ID 0349) 
suggested:

    * * * Given the significance of education and training, OSHA 
should develop a mandatory appendix to the Proposed Rule that sets 
forth the elements (including an evaluative component) of an 
acceptable education and training program.

    As noted above, OSHA agrees with these commenters that effective 
training is a key part of hazard communication. While the GHS does not 
include such requirements, the developers also recognized the 
importance of including training in national programs, and encouraged 
countries to do that. In addition, the United Nations Institute for 
Training and Research (UNITAR), which is the international focal point 
for capacity building on the GHS, is developing training courses to be 
made available to developing countries, in particular to assist them in 
adopting the GHS.
    As described, OSHA proposed a slight modification to ensure that 
employers are aware that they need to train specifically on the new 
label elements and SDS format. This modification is in the final rule, 
and the training on these aspects is to be completed prior to other 
provisions going into full effect. OSHA does not agree that other 
changes should be made to the training provisions of the HCS at this 
time. As also indicated in this document, the changes to the HCS being 
promulgated are focused on what is necessary to comply with the GHS. 
Since the GHS does not have any training requirements, the modification 
proposed and adopted by OSHA is what is necessary to ensure appropriate 
compliance with the revised standard, and does not introduce any new 
approaches or requirements.
    OSHA is planning to provide additional guidance to help ensure 
appropriate training is conducted when complying with the revised HCS. 
A draft Model Training Program was posted for comment on OSHA's Web 
page some years ago. It includes many of the concepts addressed in the 
comments received, but was never finalized. While it was designed to 
provide an array of tools from which employers could choose what they 
needed based on their workplaces (lesson plans and slides), there were 
comments received at the time that it was too long for small employers. 
OSHA believes that the model program includes important information 
about conducting appropriate training (which was also the view of other 
commenters on the program). It is being revised and updated to be 
consistent with the revised rule, and will be made available on OSHA's 
Web page. A shorter guidance document for small employers is also being 
developed.
    In addition to these training-specific tools, OSHA has other tools 
under development that could be used in training (e.g., a quick card 
with the new symbols). These too will help to address some of the 
issues that have been raised.
    Based on the above reasons, the final rule adopts the training 
provisions in the proposal. OSHA will address other comments provided 
through guidance and compliance assistance materials, rather than 
through further revisions to the rule.
    OSHA has made minor changes to the training provisions to reflect 
the new definition of hazardous chemical in the final rule. In (h)(1), 
OSHA is replacing the phrase ``new physical or health hazard'' with the 
broader term ``chemical hazard.'' Final paragraph (h)(1) requires that 
employers provide employees with effective information and training on 
hazardous chemicals in their work area at the time of their initial 
assignment, and whenever a new chemical hazard the employees have not

[[Page 17737]]

previously been trained about is introduced into their work area. 
Information and training may be designed to cover categories of hazards 
(e.g., flammability, carcinogenicity) or specific chemicals. Chemical-
specific information must always be available through labels and safety 
data sheets.
    Similarly in paragraph (h)(3)(ii), OSHA is replacing the phrase 
``The physical and health hazards'' with all of the hazards identified 
as well as the hazards not otherwise classified. Final paragraph 
(h)(3)(ii) requires that the training include the physical, health, 
simple asphyxiation, combustible dust, and pyrophoric gas hazards, as 
well as hazards not otherwise classified, of the chemicals in the work 
area. This change was necessary because the final rule covers simple 
asphyxiants, pyrophoric gas, combustible dust, and hazards not 
otherwise classified, in addition to what falls under the new 
definitions for physical and health hazards. The modification to 
paragraph (h)(3)(ii) requires employers to train employees on all of 
the chemical hazards in the workplace, rather than only physical and 
health hazards as defined in the final rule.
    (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 original 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 (See 1.1.1.6(j) of the GHS):

    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 trade 
secrets, and provide principles for countries to follow when adopting 
the GHS. These principles are consistent with the approach already 
incorporated into the HCS.
    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 trade 
secret claims to specific chemical identities. This was the primary 
difference between the current rule and the proposed revisions to the 
HCS. To be consistent with GHS, OSHA proposed 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 revised the 
text of the current rule to add consideration of percentage composition 
everywhere specific chemical identity is addressed in the provisions.
    The GHS further suggests that SDSs indicate when information has 
been withheld as confidential; that the information be disclosed to the 
competent authority upon request and under condition of 
confidentiality; that the information must be disclosed in a medical 
emergency, with mechanisms to protect it while ensuring timely 
disclosure; that the information be disclosed in non-emergency 
situations, also under conditions of protecting confidentiality; and 
that the competent authority have procedures to deal with challenges to 
this process. All of these principles have already been included in the 
trade secret provisions of the HCS, and are maintained in the final 
rule as previously promulgated. The proposed revisions simply conformed 
terminology, and added 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 
0072 and 0179), and that the current trade secret position 
should be retained (Document ID 0049). There was also a 
comment that indicated that 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 stated, 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.
    There were a few comments on the trade secret provisions proposed. 
Some expressed their support for maintaining the current approach, with 
the small revisions to conform to the GHS (Document ID 0353, 
0367, and 0371). Several indicated that the trade secret provisions 
should be extended to labels because the name of unclassified hazards 
was proposed to be included on labels, and when there is an ingredient 
of unknown toxicity, this must be indicated as well. For example, the 
American Petroleum Institute (Document ID 0376) indicated:

    Under certain conditions both the SDS and label can require text 
such as: x percent of the mixture consists of ingredient(s) of 
unknown toxicity. This statement may apply to an ingredient of a 
mixture whose percentage of composition is a trade secret. In such a 
case the trade secret provisions only apply when this statement is 
on the SDS. The current trade secret provisions do not apply to 
labels. Since the percentage composition of an ingredient can be 
required on labels as well as SDSs, the trade secret provisions 
should also apply to labels.

(Footnote omitted; See also Document ID 0344, 0381, 0382, 
and 0393.)

    With regard to the inclusion of the name of unclassified hazards on 
a label, this requirement has been deleted from the final rule. 
Therefore, listing unclassified hazards on the label no longer raises a 
trade secret concern. It should be noted that there was never a

[[Page 17738]]

requirement proposed for the ``specific chemical identity'' to be on 
the label for unclassified hazards, so even if the provision had been 
included in the final rule, it still would not have been analogous to 
the specific chemical identity required on an SDS.
    With regard to the statement regarding unknown toxicity, OSHA does 
not find that this statement merits a change to allow the trade secret 
provisions to apply to labels. It is noted in paragraph A.1.3.6.2.3 
that, where there is one or more ingredient of unknown toxicity in a 
mixture of other ingredients known to be acutely toxic, the calculation 
for predicting the acute toxicity cannot be completely accurate. 
Therefore, as suggested in the GHS, OSHA has indicated that a statement 
must be on the label and SDS indicating that a percentage of the 
mixture has unknown acute toxicity. There is no requirement to relate 
that general statement to specific ingredients, and specific chemical 
identities are not required on the label. Therefore, no trade secret 
information is required to be disclosed, and protection of the 
information under the trade secret provisions is not necessary.
    There were also comments that OSHA should allow for flexibility in 
terms for indicating information is being withheld as a trade secret, 
such as ``confidential,'' ``confidential business information,'' or 
``proprietary'' (Document ID 0376 and 0393). OSHA has never 
indicated specific terminology for claiming that information is subject 
to the trade secret provisions of the HCS, and would accept language 
such as ``confidential,'' ``confidential business information,'' or 
``proprietary'' when indicating on an SDS that information is being 
withheld. This has never been an issue in OSHA enforcement of the HCS.
    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. 
Therefore, the final maintains the proposed language for the trade 
secret provisions.
    (j) Effective dates. OSHA proposed to require training on the new 
labels and SDSs two years after publication, and all other provisions 
within three years. During the three-year transition period, employers 
would be required to be in compliance with either the existing HCS or 
the modified GHS, or both. OSHA recognized 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. It was 
indicated that this would be considered acceptable, and employers would 
not be 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.
    It should be noted that due to requirements of the Federal 
Register, a revision date of October 1, 2009, was entered into the 
proposed language to indicate the version to be used as the existing 
HCS standard. This confused some commenters (See, e.g., Document ID 
0376). There were no actual revisions introduced as of that 
date, and it is irrelevant to this final rule.
    Many comments were received in response to the ANPR 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 0022, 0144, 
0146, and 0151), many more indicated that this would not be appropriate 
(See, e.g., Document ID 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 the large 
businesses would need information from the small businesses in order to 
comply themselves (Document ID 0080 and 0123).
    There were also those who thought the phasing should be coordinated 
with other trading partners, particularly the European Union (Document 
ID 0024, 0072, 0080, 0081, 0163, 0171, and 0179). The European 
phasing is taking place over a long period of time because of the REACH 
requirements for chemicals that are going into effect and not 
necessarily because of the amount of time needed just for compliance 
with GHS. Another suggestion that had support from commenters was to 
phase in substances first, and then cover mixtures, or to have a three-
step phase-in that includes intermediates before mixtures (See, e.g., 
Document ID 0021, 0024, 0034, 0036, 0122, 0141, and 0154).
    There were also suggestions for a specific number of years, or a 
range of years, for phase-in. Some of these suggested less than 3 years 
(See, e.g., Document ID 0019, 0028, and 0064). A number 
suggested 3 to 5 years, or in some cases, 6 years (See, e.g., Document 
ID 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 0018, 0050, 0077, 0078, 
0116, 0129, 0141, and 0164).
    OSHA decided on the three-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.
    Stakeholders provided many comments, as well as testimony, on the 
proposed effective dates. As with the record submitted in response to 
the ANPR described above, the opinions ranged over a wide variety of 
effective date options.
    As noted, OSHA proposed that employers provide training regarding 
the new labels and safety data sheets two years after publication of 
the final rule. The intent of this training is to ensure that when 
employees begin to see such labels and SDSs in their workplaces, they 
understand how to use them and access the information effectively. 
Given the number of chemicals imported into American workplaces, as 
well as the number of employers who are already beginning to change 
over to the new formats, OSHA believes it is important to have this 
introductory training done before all of the labels and SDSs will be 
changed. It is not possible to pick a time frame that would ensure that 
such training is done before employees see any of these documents, but 
two years is a reasonable period of time and helps to ensure that 
employees will be trained before the new formats become the standard 
practice.
    This training is not required to address the specific hazards of 
the chemicals, or the protective measures. Employees will have already 
been trained on hazards and protective

[[Page 17739]]

measures under the existing hazard communication requirements, but they 
will not have had training on the new label elements (e.g., pictograms 
and signal words) and SDS format, nor have learned how this information 
is to be used in their workplaces. Completion of such training in two 
years will help to ensure they can use the new documents effectively 
when they begin to arrive in their workplaces.
    Some commenters thought two years would not be enough time, or who 
appeared to misunderstand what training was to be done by this date 
(See, e.g., Document ID 0330, 0344, 0351, 0361, 0390, 0397, 
and 0399). For example, the American Society of Safety Engineers and 
Industrial Health and Safety consultants indicated that the training 
should be completed within one year of the final rule (Document ID 
0336 and 0410). But the majority of those who commented agreed 
that two years was an appropriate time period in which to complete the 
training on the new label and SDS formats (See, e.g., Document ID 
0324, 0329, 0335, 0338, 0346, 0370, and 0405).
    The three-year time frame for compliance with all other 
requirements generated significant comment. Many commenters supported 
this time frame as being appropriate and feasible (See, e.g., Document 
ID 0313, 0322, 0324, 0327, 0329, 0335, 0339, 0376, 0390, 0395, 
and 0405). Others indicated that three years would not be adequate 
(See, e.g., Document ID 0342, 0371, 0399, and 0402). There 
were also comments that suggested additional time should be provided to 
distributors to ensure they have the information from suppliers to 
provide it downstream. For example, the National Association of 
Chemical Distributors (Document ID 0341) stated:

    OSHA should consider an additional 18-month phase in period for 
chemical distributors after the 3-year implementation date expires. 
This would allow for a more effective GHS while reducing any 
potential negative economic impact on small chemical distributors. 
NACD members have expressed concern that a three-year transition 
time for the entire value chain (suppliers, distributors, customers) 
presents the possibility of a bottleneck in the supply of chemicals 
* * *

    Many commenters indicated that the time frame should be longer and 
tiered, with either substances first, and then mixtures, or a three-
tiered system with substances, intermediate mixtures, and complex 
mixtures. The latter approach has been used by the EU. (See, e.g., 
Document ID 0328, 0341, 0352, 0363, 0367, 0392, 0393, and 
0400.) For example, comments on behalf of the Soap and Detergent 
Association and the Consumer Specialty Products Association indicated 
(Document ID 0344):

    Therefore, SDA and CPSA support either a sequenced approach of 
substance suppliers first and formulators last, or a longer overall 
timeframe in order to minimize the impact of undertaking this 
significant effort to reclassify substances and mixtures, develop 
revised labeling, while allowing time to deplete inventories of 
labels and products with a current label. Any consideration of 
business size for a phase-in approach would be unacceptable as 
businesses large and small use each other's products in their end-
use products; each one may rely on the upstream supplier for 
information in hazard classification.

    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 SDSs, and the new GHS labels and 
SDSs, will co-exist in workplaces is inevitable, hazard communication 
during this transition period will be confusing and less effective. It 
is therefore important to minimize the effects of the transition on the 
effectiveness of hazard communication by ensuring that it 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. If 
manufacturers of mixtures wait until the end of an extensive time 
period to complete their work, their customers might not 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.
    OSHA is also mindful of the fact that the initial HCS had a two-
year phase-in period for completion and distribution of all labels and 
SDSs, and an additional six months for all other provisions of the rule 
to be completed. There was no tiered approach to substances and 
mixtures. In that situation, the requirements for labels and safety 
data sheets were completely new, and yet timely compliance was achieved 
by most employers. Where there were situations that needed special 
consideration (such as an employer not receiving the required 
information from suppliers), the Agency made adjustments through 
enforcement policies. It should also be noted that this took place 
nearly thirty years ago, and pre-dated many of the resources available 
today that can facilitate compliance--such as access to extensive 
information online.
    As was the case in the comments to the ANPR, a number of NPRM 
participants referenced the timeline for compliance with European CLP 
requirements (See, e.g., Document ID 0328, 0361, 0367, 0377, 
and 0392). When discussing this issue in the NPRM, OSHA noted that the 
dates selected for CLP compliance were influenced significantly by 
compliance dates for REACH, rather than providing an indication of how 
long compliance should take in the absence of such competing 
responsibilities (74 FR 50403, Sept. 30, 2009).
    That being said, however, nearly two years have elapsed since the 
NPRM was published, and the EU requirements for notifications regarding 
classification of substances are now in effect. In January 2011, the 
European Chemicals Agency (ECHA) indicated that it had received over 
three million such classifications (See discussion earlier in the 
Summary and Explanation). These substance classifications are being 
made available in a public database. The availability of this 
information clearly facilitates compliance with this revised HCS. While 
chemical manufacturers and importers must review the information if 
they are using classifications performed by someone else, many of the 
classifications were being submitted by U.S. companies, and thus they 
are already substantially in compliance with the new U.S. requirements 
as well.
    Taking into consideration all of the information received from the 
public during the comment periods and in hearing testimony, as well as 
the results of the economic analysis which examines the effects of 
different compliance dates on the overall costs of compliance, the 
following effective dates have been included in the final rule. Rather 
than specifying a time frame related to the publication date of the 
final rule, OSHA is establishing dates certain for these activities to 
be completed. The following table summarizes the requirements in the 
final rule:

[[Page 17740]]



                                 Table XIII-3--Effective Dates and Requirements
----------------------------------------------------------------------------------------------------------------
      Effective completion date                      Requirement(s)                             Who
----------------------------------------------------------------------------------------------------------------
December 1, 2013.....................  Train employees on the new label elements   Employers.
                                        and SDS format.
June 1, 2015.........................  Compliance with all modified provisions of  Chemical manufacturers,
                                        this final rule, except:                    importers, distributors and
                                                                                    employers.
December 1, 2015.....................  The Distributor shall not ship containers
                                        labeled by the chemical manufacturer or
                                        importer unless it is a GHS label.
June 1, 2016.........................  Update alternative workplace labeling and   Employers.
                                        hazard communication program as
                                        necessary, and provide additional
                                        employee training for newly identified
                                        physical or health hazards.
Transition Period 5/25/12 to the       May comply with either 29 CFR 1910.1200     Chemical manufacturers,
 effective completion dates noted       (this final standard), or the current       importers, distributors, and
 above.                                 standard, or both.                          employers.
----------------------------------------------------------------------------------------------------------------

    First, final paragraph (j)(1) requires training regarding the new 
label and SDS formats to be completed by all covered employers by 
December 1, 2013. OSHA has concluded that it is necessary and 
appropriate to complete this training prior to all of the new labels 
and SDSs being completed and received in workplaces so that employees 
know how to access and use the information appropriately. Most of those 
who commented on this issue agreed with that position, and with the 
timing proposed. Those who didn't may have misunderstood exactly what 
training is being required, but we have clarified that in this 
document.
    Secondly, OSHA has not found the arguments regarding phasing in 
based on whether the product is a substance or a mixture to be 
convincing. There are many variations in the supply chain that impact 
the logic of this approach. In addition, given the current situation 
where substance classifications for the GHS have already had to be 
completed for both the EU countries, as well as other countries such as 
Japan, many suppliers involved in international trade have already had 
to complete substance evaluations. For those who have not, there is 
extensive information available as a result of these classifications 
having been done for the purpose of compliance with other authorities' 
requirements. Thus little time should be necessary to complete this 
part of the work.
    Final paragraph (j)(2) requires compliance with all of the 
provisions for preparation of new labels and safety data sheets by June 
1, 2015. This compliance date is consistent with the EU requirements 
for classification of mixtures. It also provides almost a year more 
time for compliance than was proposed. Thus it addresses a number of 
the suggestions received, but is still a reasonable time frame in terms 
of employee protections. There are two exceptions to this date. First, 
final paragraph (j)(2)(i) gives distributors an additional six months 
to distribute containers received from chemical manufacturers and 
importers with the new labels and SDSs in order to accommodate those 
they receive very close to the compliance date. Accordingly, by 
December 1, 2015, all their distributed containers must be 
appropriately labeled, and have the new SDS. Second, final paragraph 
(j)(2)(ii) gives employers until June 1, 2016, to make sure that their 
workplace labels and training programs reflect any new information 
received as a result of the final rule.
    As was proposed, final paragraph (j)(3) states that employers will 
be considered to be in compliance with the HCS during the transition 
period as long as they are complying with either the existing HCS as of 
October 1, 2011, or this revised HCS.
    Employers are encouraged to work with their suppliers to ensure 
they get the information they need by the dates they need it. While the 
final rule gives distributors and employers extra time to ensure they 
have the information before they have to be in compliance with all 
requirements, coordination will still be key to ensure everything is 
done on time. For example, mixture formulators need to make sure their 
suppliers are aware of their need to receive substance classifications 
as soon as possible. Employers would be best served to start evaluating 
their workplaces long before the year after suppliers must be in 
compliance to assess what they will need to do to bring their programs 
in line with the new requirements. As with the original rule, OSHA will 
handle individual problems through enforcement policies that recognize 
difficult issues or situations that impede compliance. Nevertheless, 
given the long time frame involved, and recognition of different 
players in the supply chain of the needs of others, OSHA expects that 
these situations will be minimal.

Summary and Explanation of Requirements in OSHA Standards Affected by 
the GHS Modifications to HCS

General Explanation
    In this final standard, OSHA has modified its current standards in 
General Industry (29 CFR Part 1910), Construction (29 CFR Part 1926), 
and Maritime (Shipyards, Marine Terminals, and Longshoring (29 CFR 
Parts 1915, 1917, and 1918, respectively)) that contain hazard 
classification and communication provisions so that they will be 
internally consistent and aligned with the GHS modifications to the 
HCS. OSHA proposed to do so on the basis of the strong support in the 
record of comments on 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 (71 FR 53617, Sept. 12, 2006) (Document ID 0031, 0038, 
0046, 0050, 0054, 0072, 0077, 0107, 0116, 0145, 0147, 0154, 0155, 0163, 
0165, 0171, and 0179). OSHA did so, and this rule contains the updates 
to the requirements in OSHA standards affected by the GHS modifications 
to HCS. Commenters also urged OSHA to complete these revisions in one 
rulemaking (Document ID 0079, 0123, 0137, 0154, and 0157). The 
comments on the proposed standard and testimony at the hearing also 
strongly supported modifying these standards for consistency with the 
GHS (Document ID 0313, 0327, 0328, 0329, 0336, 0338, 0352, 
0359, 0365, 0370, 0372, 0405, 0408, 0410, 0412, and 494 Tr. 91, 162). 
Of the commenters who specifically addressed adopting GHS provisions on 
physical hazards, many urged the

[[Page 17741]]

Agency to conform the OSHA standards to the GHS in order to minimize 
discrepancies and ensure consistency (Document ID 0012, 0018, 
0050, 0072, 0104, 0105, 0139, 0140, and 0144). 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).
    Several other commenters to the ANPR pointed out some of the 
difficulties with adoption of the GHS physical hazards criteria in OSHA 
standards (Document ID 0031, 0034, 0038, 0077, 0145, and 
0166). BASF was concerned that modifying OSHA standards to conform to 
the GHS will cause them to deviate from the national consensus 
standards they were based on (Document ID 077). In addition, 
some ANPR commenters recommended that OSHA limit changes only to 
standards that directly refer to the HCS (Document ID 0047, 
0064, 0077, 0104, and 0115). OSHA acknowledged these concerns when 
developing the NPRM.
    OSHA's NPRM reflected the advantages of harmonizing OSHA's 
standards, but also took 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 (74 FR 
50280, Sept. 30, 2009). OSHA proposed modifying requirements in 
primarily the substance-specific health standards and in physical 
hazards definitions and terminology for the purposes of internal 
consistency and compatibility with the GHS-modified Hazard 
Communication Standard (HCS).
    Building and Trades Construction Department of AFL-CIO (BTCD) and 
Northrup Grumman Shipbuilding, in response to the NPRM, requested that 
OSHA again review the standards, and the Agency has done so (Document 
ID 0359 and 0395). OSHA reviewed all its standards, the 
comments, and the entire record and has decided to maintain the 
modifications to the substance-specific standards as proposed, except 
for some minor changes that are explained below.
Substance-Specific Health Standards
    In the NPRM, OSHA updated the substance-specific health standards 
in General Industry, Construction, and Maritime, whether they 
specifically referenced HCS or contained their own hazard communication 
requirements. OSHA proposed to modify these standards as follows:
    [ssquf] Revise the provisions covering workplace signs to require 
warning statements that are consistent with the GHS modifications to 
HCS;
    [ssquf] Revise all standards to reference the modified HCS for 
labels, safety data sheets, and training, and identify the hazards that 
need to be addressed;
    [ssquf] Maintain the requirement to avoid creating dust currently 
in some substance-specific health standards for which GHS modifications 
contain no equivalent statements at this time;
    [ssquf] Maintain or specify language for contaminated clothing and 
debris;
    [ssquf] Update definitions in Sec.  1910.1450, Occupational 
Exposure to Hazardous Chemicals in Laboratories, to maintain 
compatibility with the modified HCS; and
    [ssquf] 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.
Workplace Warning Language on Signs and Labels
    OSHA proposed 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 heath 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 proposed to modify the language to be compatible 
with GHS and consistent throughout the OSHA standards. Labels for 
products, mixtures, and raw materials are included in the GHS-modified 
HCS and are required to be compliant with it. Labels required by the 
current standards for contaminated clothing, PPE, and waste and debris, 
which are not addressed in the GHS, are retained, but their language 
has been changed to be as reflective of GHS terminology as possible.
    The vast majority of persons and entities who commented on the 
issue in response to the NPRM supported OSHA's harmonization of the 
signage and labeling currently required in its substance-specific 
standards with the modifications to HCS (Document ID 0313, 
0315, 0327, 0328, 0329, 0330, 0336, 0338, 0344, 0365, 0370, 0372, 0376, 
0381, 0382, 0383, 0405, 0408, and 0410). NIOSH pointed out that the 
consistent language on signs, labels, and SDSs would avoid confusion 
and allow for easy translation into other languages (Document ID 
0414). AIHA, in supporting the modification of language for 
signs and labels, noted that the action was consistent with GHS and the 
goal of harmonization. They envisioned clearer warnings, improved 
comprehension, and better self-protection by workers (Document ID 
0365). Companies such as Ecolab, Product Safety Solutions, 
DuPont Company, Phylmar Group, Stericycle, Procter & Gamble, Clariant 
Corporation, 3M, Industrial Health and Safety Consultants, and Wacker 
Chemical specifically addressed the issue of affected standards and 
stressed that aligning the standards with GHS would bring needed 
consistency and aid employee understanding (Document ID 0313, 
0329, 0335, 0338, 0339, 0351, 0381, 0383, 0405, and 0410). Lawrence R. 
Klein of DuPont (Document ID 0329) commented that:

    * * * hazard communication regardless of whether * * * general 
chemicals or substance specific chemicals regulated under other OSHA 
standards, will prove to be beneficial for industry. Through 
adequate training * * * and consistent, easily comprehensible hazard 
and precautionary statements, via workplace signs or chemical 
labels, the safety and protection of employees will be enhanced.

    Ameren added that the language proposed for the substance-specific 
standards accurately conveyed the hazards (Document ID 0330). 
Associations that addressed this issue also provided strong support. 
ORC, ASSE, NAHB, API, Alliance of Hazardous Materials Professionals, 
National Paint and Coatings Association, Soap and Detergent 
Association, ACC, and AISI agreed with OSHA that modifying the 
standards will provide consistency and aid in employee understanding 
(Document ID 0327, 0328, 0336, 0344, 0370, 0376, 0393, and 
0408). Many commenters followed up with testimony at the informal 
public hearings. NIOSH testified that there would be better 
identification of what was a hazard and the nature of the hazard 
(Document ID 0494 Tr. 50). BCTD AFL-CIO testified that the 
specific format and vocabulary for labels would facilitate hazard 
communication across a range of English literacy, as one in four 
construction workers speaks a language other than English, and two in 
three entering workers speak Spanish. They said that the signs, 
symbols, and phrases will make it easier for employees to work safely 
with hazardous products

[[Page 17742]]

(Document ID 0497 Tr. 7, 16, 33-34, 62, 66). ORC Worldwide 
testified their companies have significant global operations and so 
support concurrent harmonization of hazardous communication components 
(Document ID 0497 Tr. 88, 91, 99). SIRC generally supported 
the principles of the GHS update (Document ID 0494 Tr. 118). 
ASSE agreed that it is important for consistency to have the same 
language on the label, SDS, and regulated area sign (Document ID 
0496 Tr. p. 362). In speaking about all labeling requirements, 
USSW (Document ID 0499 Tr. 136-37) testified:

    It's imperative that the information on the labels is consistent 
from product to product. Incorporating the GHS labeling system with 
pictograms and single-word hazard statements will assist workers to 
quickly recognize hazards.

AIHA summed up the support from commenters and testifiers by declaring 
that the GHS modifications will improve quality and consistency of 
hazard communication information (Document ID 0496 Tr. 415).
    Several commenters to the NPRM, while supporting the modifications, 
raised potential problems with warnings for substance-specific health 
standards' labels and regulated area signs. Northrop Grumman agreed 
with the wording of the regulated area signs and that it would enhance 
employee information, although there was concern that this was a change 
in OSHA's policy of allowing supplemental language on labels and signs 
that would enhance the information (Document ID 0395). OSHA 
has not changed its policy on regulated area signs with this rulemaking 
and will continue to allow supplemental language on labels and signs. 
ASSE suggested that, under the proposal, the term ``Cancer Agent'' 
would be retained in the thirteen identified carcinogens standard, 
though the ASSE did not believe the problems caused by this 
inconsistency would be significant (Document ID 0336). OSHA 
notes that all cancer warnings, including ``Cancer Agent'' and ``Cancer 
Suspect Agent,'' have been changed to ``May Cause Cancer,'' so there is 
no inconsistency. NAHB addressed the issue of the cancer warning in a 
comment to the ANPR, 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). Like other commenters, NIEHS 
supported consistency, but thought ``May Cause Cancer'' may not be 
strong enough, and recommended ``Causes Cancer'' be retained. The 
International Chemical Workers Union Council agreed that ``May Cause 
Cancer'' was not strong enough; they preferred ``Causes Cancer'' 
because it was a more definite statement about the health hazard. They 
were concerned that some workers might not see the warning as a clear 
indication of the material causing cancer and act accordingly (Document 
ID 0456). Dr. Michelle Sullivan also supported consistency 
among SDSs, labels, and in-plant warning signs, but cautioned that 
training would be needed especially on ``May Cause Cancer'' (Document 
ID 0382). OSHA agrees that training will be needed and that 
appropriately trained workers who see the phrase ``May Cause Cancer'' 
will be well warned and benefit from the use of a consistent hazard 
statement for all carcinogens.
    The current substance-specific health standards that are regulated 
as carcinogens have varying hazard statements on signs and labels, as, 
for example, from ``Cancer Hazard'' for inorganic arsenic (29 CFR 
1910.1018) to ``Cancer-Suspect Agent'' for vinyl chloride (29 CFR 
1910.1017) to ``May Cause Cancer'' for methylenedianiline (MDA) (29 CFR 
1910.1050). As stated in the preamble to the proposed standard, these 
warnings appeared to suggest gradations of cancer hazards, but they 
were not intended that way. The standards were promulgated over many 
years, and the differences in the warning language reflect the language 
widely used for each cancer warning at the time of promulgation, not 
the degree of hazard (74 FR 50405, Sept. 30, 2009). This inconsistency 
has long been a problem, especially in workplaces where two or more 
OSHA-regulated carcinogens are used. The final rule's revision to the 
substance-specific health standards will solve the problem of different 
warning statements by standardizing the carcinogen warning language to 
``May Cause Cancer'' for each standard. This will lead to clearer and 
more timely recognition of the hazard and, with training, better 
understanding of the potential for developing cancer.
    OSHA understands the points made by commenters who argued for 
another warning for cancer that might appear stronger, but any other 
warning would not be consistent with GHS and thus workers would not 
benefit from the global consistency of a single hazard statement for 
carcinogenicity. Moreover, OSHA believes that, with training, workers 
will understand the seriousness of the warning and benefit from seeing 
only one warning on carcinogens in the workplace. OSHA has concluded 
that the signal words and hazard statements, including ``May Cause 
Cancer,'' in its substance-specific health standards will provide 
better hazard information to employers, and has carried through the 
changes proposed in the NPRM to the final rule.
    See Table XIII-4 for a comparison of the signs' final language to 
that currently required.
BILLING CODE 4510-26-P

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BILLING CODE 4510-26-C

[[Page 17748]]

    OSHA's proposal to change the signage requirements in the 
substance-specific standards was nearly universally supported by 
commenters. Product Safety Solutions, AHMP, National Paint and Coatings 
Association, Ameren, Wacker Chemical Corp, ASSE, Stericycle, Phylmar 
Regulatory Roundtable, Soap and Detergent Association/Consumer 
Specialty Products Association, Ecolab, Inc., AIHA, ORC Worldwide, 
National Association of Homebuilders, API, Procter & Gamble Company, 
Dr. Michelle Sullivan, Clariant Corporation, American Chemical Council, 
3M, AISI (American Coke and Coal Chemicals Institute), Industrial 
Health and Safety Consultants, and NIOSH, in their comments to the 
NPRM, specifically supported the harmonization of signage required in 
the substance-specific standards (Document ID 0313, 0327, 
0328, 0330, 0335, 0336, 0338, 0339, 0344, 0351, 0365, 0370, 0372, 0376, 
0381, 0382, 0383, 0393, 0405, 0408, 0410, and 0412). USSE, agreeing 
with the commenters above, testified that having the same wording on 
regulated-areas signs would be helpful to workers as they move around 
and it is better for them to see the same information they have been 
trained on (Document ID 0499 Tr. 165).
    Commenters raised several signage issues. Dow Chemical advocated 
the elimination of signs in substance-specific health standards, 
arguing that there was no need for signs since the chemical will be 
labeled and workers can also refer to an SDS (Document ID 
0353). OSHA disagrees. The substance-specific standards' sign 
requirements cover regulated areas of facilities that are by definition 
high-exposure or potentially high-exposure areas. They are among the 
most dangerous areas in a facility, which is why OSHA requires signs. 
Moreover, contrary to what Dow assumes, product labels may not always 
be available in these circumstances. Thus, OSHA disagrees with Dow 
Chemical and believes the signs convey crucial information about the 
chemical hazard in a regulated area and that the signs benefit not only 
the well-trained worker but also other workers who might be near, or 
inadvertently enter, the regulated area.
    The Battery Council International (Document ID 0390) had 
suggestions for language on regulated area signs for the lead standard, 
29 CFR 1910.1025. First, they requested that OSHA change the language 
from ``Causes Damage to the Central Nervous System'' to ``May Cause 
Damage to the Central Nervous System,'' since nerve damage may or may 
not occur depending on whether or not the facility has taken proper 
precautions. However, as discussed above, OSHA has updated the signs to 
be consistent with GHS labeling to ensure that the worker is receiving 
the same message and this would provide better identification of the 
hazard. Therefore, OSHA has retained the proposed language for lead 
regulated area signs in the final.
    The Battery Council International also requested that OSHA retain 
the original language Sec.  1910.1025(m)(2) so that it would be clear 
that other signage may also be used in places where required (Document 
ID 0390). For example, it reported that California has such a 
signage requirement under Proposition 65. OSHA agrees that, in some 
very specific cases, other warnings may be necessary for lead. Thus, 
the current requirement that, ``The employer may use signs required by 
other statutes, regulations or ordinances in addition to, or in 
combination with, signs required by this paragraph,'' has been retained 
in the final rule for the lead standard at Sec.  1910.1025(m)(2)(iv).
    OSHA concludes that the proposed changes, which are as close as 
possible to the GHS terminology, are essential in order to make the 
warnings on signs consistent with each other, as well as labels, to the 
extent possible. These consistent warning signs will provide the best 
hazard communication in the relevant workplace regulated areas. The 
proposed changes to the signage requirements of the substance-specific 
standards have been carried through to the final rule.
Hazard Communication, Classification and Labels
    OSHA's current substance-specific standards are inconsistent in 
that some have their own communication of hazards requirements, while 
other standards reference the HCS, and still other standards have no 
requirements for labels and safety data sheets in their sections. 
Although these latter standards are missing requirements, they still 
are covered by HCS. Similarly for labels, while most substance-specific 
standards require labels on containers of raw materials, mixtures, and 
products, some specify specific language while others reference the 
HCS. As proposed, and as carried forward in this final rule, OSHA has 
standardized the language for hazard communication and has removed the 
requirements for specific language labels from the ``Communications of 
hazards'' paragraphs of the substance-specific standards. The new 
paragraph in each substance-specific standard uses the following model 
format:

    Hazard Communication--General.
    (i) Chemical manufacturers, importers, distributors and 
employers shall comply with all requirements of the Hazard 
Communication Standard (HCS) (29 CFR 1910.1200) for [chemical name].
    (ii) In classifying the hazards of [chemical name] at least the 
following hazards are to be addressed: [hazard information].
    (iii) Employers shall include [chemical name] in the hazard 
communication program established to comply with the HCS. Employers 
shall ensure that each employee has access to labels on containers 
of [chemical name] and to safety data sheets, and is trained in 
accordance with the requirements of HCS and paragraph [Training 
paragraph] of this section.

    By adding this paragraph in each substance-specific health 
standard, OSHA achieves consistency across standards and with GHS 
principles. Some commenters indicated that the chemicals covered by the 
substance-specific standards should not be classified any differently 
than any other chemical in regard to the health hazards included on a 
label or SDS (See, e.g., Document ID 0365). That was OSHA's 
intent. OSHA has clarified the regulatory language to minimize 
confusion. The final rule, like the proposal, requires compliance with 
the HCS in each substance-specific standard.
    OSHA believes that requiring standards to reference HCS will ensure 
consistency with the GHS revisions and across the standards and 
consistency when the specific chemical is part of a mixture. Removal of 
the current specific warning language was essential for adoption of the 
GHS language. Retention of these provisions in the standards would 
result in the untenable situation of two potentially conflicting 
requirements, only one of which (the reference to HCS) would be in 
accord with the GHS-modified HCS. Moreover, as OSHA noted in the 
preamble to the proposed standard, the hazard statements specified for 
the chemical in the standard might not be correct when the chemical is 
part of a mixture. As for the current standards that simply referenced 
HCS, employers could choose any language and format that conveyed the 
necessary information. This approach is no longer allowed because, as 
OSHA has found in adopting the GHS approach, consistency in labeling is 
key to effective communication of hazards. The vast majority of 
commenters agreed. For example, AHMP noted that eliminating language 
inconsistent with established hazard statements will facilitate hazard 
communication and should not result in lower protection (Document ID 
0327). Others, including NIOSH, DuPont,

[[Page 17749]]

Ameren, ASSE, Ecolab, Inc., AIHA, ORC Worldwide, NAHB, API, Procter & 
Gamble, Dr. Michelle Sullivan, ACC, 3M, AISI, Industrial Health and 
Safety Consultants, and American Coke and Coal Chemicals Institute, 
agreed (Document ID 0329, 0330, 0336, 0351, 0365, 0370, 0372, 
0376, 0381, 0382, 0393, 0405, 0408, 0410, and 0412). Commenters noted 
that for the benefits of consistency to accrue, harmonization is 
essential (Document ID 0313, 0315, 0327, 0328, 0329, 0330, 
0335, 0336, 0338, 0344, 0365, 0370, 0372, 0376, 0381, 0382, 0383, 0393, 
0405, 0408, and 0410). NIEHS Worker Education and Training Program 
agreed, testifying that consistency of labels and safety data sheets is 
important to help employees recognize hazards and be able to deal with 
them effectively (Document ID 0497 Tr. 104). Phylmar 
Regulatory said that standardized label elements will be more effective 
in communicating hazard information (Document ID 0497 Tr. 108-
109). AIHA testified that standardized labels will make hazard 
identification easier and the pictograms will be useful in workplaces 
where English language reading is limited (Document ID 0496 
Tr. 415). USSW affirmed that one hazard communication system would be 
best (Document ID 0499 Tr. 178). OSHA believes all these 
commenters provide important and compelling reasons for the labels 
required by the substance-specific standards to be consistent with the 
GHS modifications to HCS.
    For classification purposes, OSHA proposed to provide guidance on 
the potential health outcomes that must be addressed when classifying a 
substance by setting forth the health end-points (outcomes) for each 
substance-specific health standard. The Agency did not attempt to 
formally classify each substance; rather, OSHA provided a proposed list 
of health effects to assist the classifier in determining what must be 
considered for inclusion on the new labels. The GHS classification 
process for a specific substance dictates the actual hazard warnings 
and precautionary statements that are required on the new GHS-compliant 
labels and SDSs. In determining the hazards to include for each 
substance-specific health standard, the Agency's primary sources on 
health effects were the information gained in its own rulemakings and 
subsequent experience, the NIOSH Pocket Guide to Chemical Hazards 
(2005), and the International Chemical Safety Cards (ICSCs). The ICSCs 
are an undertaking of the International Programme on Chemical Safety 
(IPCS) (a joint activity of three cooperating International 
Organizations, namely, the United Nations Environment Programme (UNEP), 
the International Labour Office (ILO), and the World Health 
Organization (WHO)) and are peer reviewed by a group of internationally 
recognized experts (Document ID 0412.2). 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, Labeling 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 to be considered for 
hazard classification in the substance-specific health standards based 
on either of two criteria: (1) The health hazard was the basis for the 
original rulemaking; or (2) the health hazard was asserted by OSHA, 
NIOSH, or IPCS, and confirmed by a second source. For example, 
acrylonitrile (AN) (Sec.  1910.1045) was regulated by OSHA based on its 
carcinogenicity. Skin sensitization was acknowledged by OSHA, IPCS, and 
EU; skin irritation by OSHA, NIOSH, and EU; respiratory tract 
irritation by IPCS and EU; eye irritation by OSHA, NIOSH, and IPCS; 
liver effects and central nervous system effects by IPCS and NIOSH; 
acute toxicity by OSHA, IPCS, and EU; and flammability by IPCS, NIOSH, 
and EU. Because all these effects met the criteria for inclusion, skin 
sensitization, skin irritation, respiratory irritation, eye irritation, 
liver effects, central nervous system effects, acute toxicity, and 
flammability were listed as potential hazards in the acrylonitrile 
standard.
    OSHA's approach, including its choice of sources for health 
effects, was generally supported by many commenters to the proposal 
(Document ID 0329, 0339, 0351, 0370, and 0376). However, some, 
including NIOSH, AIHA, ASSE, Ameren, Stericycle, Wacker Chemical 
Corporation, and 3M Corporation, wanted OSHA to add other sources 
(Document ID 0233, 0330, 0338, 0365, 0405, and 0412). NIOSH 
suggested OSHA look at OECD SIDS, ESIS, NOAA, NLM, NLM-TOXSEEK, NLM-
TOXNET, IPCS, CCOHS, and GESTIS (Document ID 0412). AIHA 
commented that substance-specific health standards should be classified 
the same as other chemicals and that other references such as ATSDR 
Toxicological Profiles, IRIS Toxicological Reviews, WHC Monographs, 
CICADS, OECD SIDS, and Patty's Toxicology should be used (Document ID 
0365). Wacker Chemical Corporation recommended IARC be 
included and that one recognized body's determination of a hazard 
should be sufficient (Document ID 0335). ASSE urged inclusion 
of ACGIH documentation of TLVs and RELs and precautions developed by 
manufacturers from testing and epidemiological studies. ASSE submitted 
a long list of sources including NSC's Fundamentals of Industrial 
Hygiene, The Industrial Environment--Its Evaluation and Control, 
Patty's Industrial Hygiene and Toxicology, Casarett & Doull's 
Toxicology, The Dose Makes the Poison, Quick Selection Guide to 
Chemical Protective Clothing, U.S. DHHS Seventh Annual Report on 
Carcinogens, AIHA Engineering Field Reference Manual, and 17 others 
(Document ID 0336). AIHA urged OSHA to have the hazards for 
the substance-specific standards considered, but not be mandatory. It 
recommended additional references such as ATSDR Toxicological Profiles, 
IRIS Toxicological Reviews, EHC Monographs, CICADS, OECD SIDS, and 
Patty's Toxicology (Document ID 0365). Ameren would have OSHA 
add ACHIS and AIHA sources (Document ID 0330). Stericycle 
advocated adding Industrial Chemical Safety Cards, European Commission, 
and ACGIH as secondary sources (Document ID 0338). Still 
others, such as ASSE, API, AHMP, Product Safety Solutions, National 
Paint and Coatings Association, and Industrial Minerals Association--
North America, deemed OSHA's choice of sources inadequate (Document ID 
0313, 0327, 0328, 0338, 0376, and 0379). USSW (Document ID 
0403) found lists such as IARC's and NTP's useful, but wanted 
OSHA to state in the regulatory text that a chemical on one or more of 
these lists was sufficient to classify it as hazardous (although the 
absence of a chemical on a list does not mean it is not hazardous). It 
also wanted OSHA to use lists in enforcement.
    Commenters also raised other issues in this regard. API believed 
OSHA should just reference the GHS criteria, while ASSE wanted OSHA to 
use other authoritative references (Document ID 0336 and 
0376). Both AHMP and Product Safety Solutions were concerned the NIOSH 
Pocket Guide and International Chemical Safety Cards had not been 
subject to rulemaking and could be overly conservative, even though 
they felt these sources could be used as information, but not as 
precedent if significant contradictory information is presented 
(Document ID 0313 and 0327). National Paint and Coatings 
Association commented that the substance-specific standards' health

[[Page 17750]]

hazards should remain as published and only new information should be 
subject to the two-reference rule (Document ID 0328). Still 
other commenters, including DuPont Company, Soap and Detergent 
Association and Consumer Specialty Products Association, Procter & 
Gamble, and Dr. Michelle Sullivan, expressed concern about whether the 
sources OSHA was using were to be current or updated, as newer editions 
become available (Document ID 0329, 0344, 0381, and 0382).
    OSHA believes these comments reflect a misunderstanding of what 
OSHA proposed for its substance-specific health standards and how the 
sources were used to yield health effects to be considered in 
classifying all health hazards but not to perform a formal 
classification. (See 74 FR at 50411, Sept. 30, 2009, for the preamble 
explanation). The substance-specific health standards are unique in 
that they were all the subject of rulemaking, enabling the Agency to 
collect extensive information on sources and on health effects. That 
collection of information, coupled with the Agency's own expertise, 
enabled the Agency to confidently select sources for these regulated 
chemicals that would provide adequate information to classifiers. OSHA 
disagrees with commenters who suggested its chosen sources were 
inadequate. Some commenters recommended other sources. OSHA believes 
that these other sources can be useful in classifying hazards, and can 
certainly be used by classifiers in evaluating the hazards related to 
chemicals regulated by the substance-specific standards. At issue here, 
though, is the method OSHA has determined to use for selecting a list 
of hazard endpoints that, at a minimum, must be considered to provide 
accurate warnings on labels for its substance-specific standards. OSHA 
has concluded that the method it used in the proposal is scientifically 
sound and appropriate.
    In complying with the HCS, as discussed above, classifiers must 
take into account available scientific information about the hazards of 
the chemical being classified, which could include information found in 
the other sources noted by the commenters. The manufacturer, 
distributor, or importer must still classify and categorize each 
regulated chemical (in the substance-specific health standards) in 
compliance with the GHS-modified HCS and its appendices. The lists of 
endpoints for each substance-specific standard are the minimum that 
must be considered. The manufacturer or importer has leeway to use 
additional primary studies and sources to evaluate the substance-
specific chemical and is free to add health effects' endpoints as 
appropriate according to the studies or sources. As discussed 
previously in this section, the HCS generally uses a weight-of-evidence 
approach in classifying health hazards. Therefore, a superior source or 
significant and compelling contradictory information to a particular 
source usually must be weighed with the total body of evidence.
    IMA-NA suggested that OSHA's methodology for determining the list 
of health effects to be considered by classifiers does not meet the 
requirements of the Information Quality Act (Document ID 
0233). OSHA disagrees. That statute, and the guidelines 
published under it (discussed in more detail above), require that 
agencies take steps to ensure the ``quality, objectivity, utility, and 
integrity'' of information they disseminate. Similar to its response to 
the concern regarding TLVs, discussed above, OSHA does not believe that 
it is disseminating information for purposes of the IQA when it merely 
requires that manufacturers and importers consider specific health 
effects listed for each substance-specific standard in classifying the 
chemical under the HCS. However, even if it were disseminating 
information in the final rule, OSHA believes that it has complied with 
the applicable requirements of the IQA. OSHA has fully described the 
methods by which it determined the listed health effects for each 
substance, relied only on respected health compilations prepared by 
governmental agencies or subject to peer review, and subjected its 
analysis to notice and comment in this rulemaking. This adequately 
assures the quality, objectivity, utility, and integrity of any 
dissemination of information involved in these provisions of the final 
rule.
    OSHA received no comments on the particular hazards proposed for 
each substance-specific health standard, and retained them in the final 
rule. The endpoints for each substance-specific standard are listed in 
Table XIII-5, ``Health Effects Determined for the Substance-Specific 
Standards.''

   Table XIII-5--Health Effects Determined for the Substance-Specific
                                Standards
------------------------------------------------------------------------
        Standard No.                Substance          Health effects
------------------------------------------------------------------------
1910.1001, 1915.1001,         Asbestos............  Cancer and lung
 1926.1101.                                          effects.
1910.1003...................  4-Nitrobiphenyl.....  Cancer.
1910.1003...................  Alpha-Naphthylamine.  Cancer; skin
                                                     irritation; and
                                                     acute toxicity
                                                     effects.
1910.1003...................  Methyl chloromethyl   Cancer; skin, eye,
                               ether.                and respiratory
                                                     effects; acute
                                                     toxicity effects;
                                                     and flammability.
1910.1003...................  3,3'-                 Cancer and skin
                               Dichlorobenzidine     sensitization.
                               (and its salts).
1910.1003...................  Bis-Chloromethyl      Cancer; skin, eye,
                               ether.                and respiratory
                                                     tract effects;
                                                     acute toxicity
                                                     effects; and
                                                     flammability.
1910.1003...................  Beta-Naphthylamine..  Cancer and acute
                                                     toxicity effects.
1910.1003...................  Benzidine...........  Cancer and acute
                                                     toxicity effects.
1910.1003...................  4-Aminodiphenyl.....  Cancer.
1910.1003...................  Ethyleneimine.......  Cancer;
                                                     mutagenicity; skin
                                                     and eye effects;
                                                     liver effects;
                                                     kidney effects;
                                                     acute toxicity
                                                     effects; and
                                                     flammability.
1910.1003...................  Beta-Propiolactone..  Cancer; skin
                                                     irritation; eye
                                                     effects; and acute
                                                     toxicity effects.
1910.1003...................  2-                    Cancer.
                               Acetylaminofluorene.
1910.1003...................  4-Dimethylaminoazo-   Cancer; skin
                               benzene.              effects; and
                                                     respiratory tract
                                                     irritation.
1910.1003...................  N-                    Cancer; liver
                               Nitrosodimethylamin   effects; and acute
                               e.                    toxicity effects.
1910.1017...................  Vinyl chloride......  Cancer; central
                                                     nervous system
                                                     effects; liver
                                                     effects; blood
                                                     effects; and
                                                     flammability.
1910.1018...................  Inorganic arsenic...  Cancer; liver
                                                     effects; skin
                                                     effects;
                                                     respiratory
                                                     irritation; nervous
                                                     system effects; and
                                                     acute toxicity
                                                     effects.

[[Page 17751]]

 
1910.1025, 1926.62..........  Lead................  Reproductive/
                                                     developmental
                                                     toxicity; central
                                                     nervous system
                                                     effects; kidney
                                                     effects; blood
                                                     effects; and acute
                                                     toxicity effects.
1910.1026, 1915.1026,         Chromium VI.........  Cancer; skin
 1926.1126.                                          sensitization; and
                                                     eye irritation.
1910.1027, 1926.1127........  Cadmium.............  Cancer; lung
                                                     effects; kidney
                                                     effects; and acute
                                                     toxicity effects.
1910.1028...................  Benzene.............  Cancer; central
                                                     nervous system
                                                     effects; blood
                                                     effects;
                                                     aspiration; skin,
                                                     eye, and
                                                     respiratory tract
                                                     irritation; and
                                                     flammability.
1910.1029...................  Coke oven emissions.  Cancer.
1910.1043...................  Cotton Dust.........  Lung effects.
1910.1044...................  1,2-dibromo-3-        Cancer; reproductive
                               chloropropane         effects; liver
                               (DBCP).               effects; kidney
                                                     effects; central
                                                     nervous system
                                                     effects; skin, eye,
                                                     and respiratory
                                                     tract irritation;
                                                     and acute toxicity
                                                     effects.
1910.1045...................  Acrylonitrile (AN)..  Cancer; central
                                                     nervous system
                                                     effects; liver
                                                     effects; skin
                                                     sensitization;
                                                     skin, respiratory,
                                                     and eye irritation;
                                                     acute toxicity
                                                     effects; and
                                                     flammability.
1910.1047...................  Ethylene oxide (EtO)  Cancer; reproductive
                                                     effects;
                                                     mutagenicity;
                                                     central nervous
                                                     system; skin
                                                     sensitization;
                                                     skin, eye, and
                                                     respiratory tract
                                                     irritation; acute
                                                     toxicity effects;
                                                     and flammability.
1910.1048...................  Formaldehyde........  Cancer; skin and
                                                     respiratory
                                                     sensitization; eye,
                                                     skin, and
                                                     respiratory track
                                                     irritation; acute
                                                     toxicity effects;
                                                     and flammability.
1910.1050, 1926.62..........  Methylenedianiline    Cancer; liver
                               (MDA).                effects; and skin
                                                     sensitization.
1910.1051...................  1,3 Butadiene (BD)..  Cancer; eye and
                                                     respiratory tract
                                                     irritation; center
                                                     nervous system
                                                     effects; and
                                                     flammability.
1910.1052...................  Methylene chloride..  Cancer; cardiac
                                                     effects; central
                                                     nervous system
                                                     effects; liver
                                                     effects; and skin
                                                     and eye irritation.
------------------------------------------------------------------------

    The NPRM retained specific language for labels in the substance-
specific health standards for containers of contaminated clothing or 
waste and debris to ensure that protection gained from communicating 
these hazards to the downstream recipients of the materials would not 
be lessened. The proposal, however, updated the language to be 
consistent with the GHS. The labeling requirements in these standards 
are part of broad protections, resulting from PELs and ancillary 
provisions such as exposure monitoring, personal protective equipment, 
and medical surveillance. These requirements for labeling containers of 
contaminated clothing, PPE, and waste and debris have been an integral 
part of the standards since their promulgation. To simply conform the 
labeling requirements for these kinds of containers to the GHS-modified 
HCS rule would not offer the extra protection currently provided in 
these standards; because of the variation in the quantity of chemicals 
in the containers of contaminated clothing, PPE, and waste and debris, 
the chemical concentration may be lower than the specified cut-off 
values/concentration limits. In such a case, if OSHA only relied on the 
GHS-modified HCS labeling requirement, labeling for these containers 
may not be triggered and protections would be lessened.
    Commenters agreed that specific language for labels on containers 
of contaminated clothing and waste and debris should be maintained. For 
example, Ameren and 3M Corporation commented that maintaining specific 
language for labels on contaminated clothing and waste/debris 
containers for the substance-specific health standards will provide 
adequate warnings to all (Document ID 0330 and 0405). AIHA, in 
supporting the specific labels, noted that the workplace-contaminated 
materials are not hazardous chemicals in commerce; thus, these special 
labels are not inconsistent with GHS. Further, AIHA said that because 
recipients of these containers are accustomed to specific warnings, a 
change, such as elimination of the specific warning language because it 
might not be required by GHS, might be perceived as a change in hazard 
(Document ID 0365). The Battery Council International urged 
OSHA not to eliminate the label language requiring the disposal of 
lead-contaminated waste water in accordance with applicable local, 
state, or federal regulations in Sec.  1910.1025(m)(2) for contaminated 
clothing. OSHA agrees that this information is important and is not 
inconsistent with GHS labeling. Therefore, OSHA has retained this 
language for the labels for contaminated clothing and equipment in the 
final rule. AISI and Industrial Health and Safety Consultants urged 
OSHA to require that the language on containers of contaminated 
clothing and waste/debris be in accord with the GHS guidelines. Such 
harmonization would maintain consistency with other labeling and 
minimize confusion of downstream handlers (Document ID 0408). 
In addition, Industrial Health and Safety Consultants felt that 
containers of contaminated clothing and waste/debris should be 
classified according to the HCS and the specific language on the label 
should be eliminated (Document ID 0410). As discussed below, 
OSHA does not agree. Industrial Health and Safety Consultants also 
suggested that OSHA require HCS classification and labeling of 
contaminated waste clothing and waste for all chemicals (Document ID 
0410). OSHA did not propose such extensive new requirements 
for containers of chemically contaminated clothing and waste and 
debris. These requirements were not part of HCS and would be a 
significant addition to the final rule.
    OSHA agrees with the commenters who advocate retaining the warnings 
and harmonizing these labels for contaminated clothing and waste and

[[Page 17752]]

debris containers, and did so to the extent possible. (See 74 FR 50434-
50439, Sept. 30, 2009). However, classifying containers of chemically 
contaminated clothing and waste and debris consistent with GHS would be 
an impossible task, as substances found on contaminated clothing and 
waste and debris often occur in unknown, varying, and frequently small 
quantities. In order to ensure and maintain protection for employees in 
workplaces that receive these containers, labeling of the hazards with 
specific language is essential. The warnings, like all other warnings, 
are most effective when they are consistent with each other and, to the 
extent possible, with the GHS language. This consistency was achieved 
with the proposed language. Therefore, the proposed language for the 
substance-specific standards remains unchanged and is finalized in this 
rulemaking.
    OSHA is adding two warnings to the Cadmium standard, which were 
left out of one paragraph of the proposal, through an error. In the 
NPRM, OSHA proposed that the warning labels for waste, scrap, or debris 
be required to include ``Danger''; ``Contains Cadmium''; and ``May 
Cause Cancer'' in paragraph 1910.1027(m)(3)(ii). The warnings ``Causes 
Damage to Lungs and Kidneys'' and ``Avoid Creating Dust'' were 
inadvertently left out of this paragraph. (The NPRM properly included 
these two warnings in paragraph 1910.1027(i)(2)(iv) for bags and 
containers of contaminated protective clothing and equipment.) OSHA is 
correcting this error by adding these warnings in this final standard, 
making the Cadmium standard consistent with the other substance-
specific standards and, to the extent possible, with GHS.
    In addition, for labels of bags or containers of contaminated 
clothing and equipment, OSHA has determined precautionary statements 
that address creating dust in the current substance-specific health 
standards must be retained even though there is no GHS equivalent. At 
this time, a work group formed under the UN Sub-Committee of Experts 
for the GHS (UN Sub-committee) is working to finalize issues related to 
hazard and precautionary statements. OSHA has recommended to the UN 
Sub-committee to adopt the phrase ``avoid creating dust'' as a 
precautionary statement, if this statement is adopted as a 
precautionary statement, then this statement will be consistent with 
the GHS. However, if the UN Sub-committee does not adopt such a 
statement, OSHA intends to continue to require the dust statements in 
those paragraphs for labels of bags and containers of contaminated 
clothing and equipment since OSHA has concluded that removing these 
statements would be a lessening of protection. An example of 
requirements for those statements can be found in OSHA's Cadmium 
standard, Sec.  1910.1027(i), (k), and (m). OSHA also inadvertently 
removed the term ``Avoid Creating Dust'' from the Asbestos labeling 
requirements in Sec.  1910.1001(j) and Sec.  1926.1101(l) of the 
proposal. As discussed above, OSHA believes that this is a unique 
statement and should be retained. OSHA is correcting this error by 
reinstating this phrase in the asbestos labeling requirements in Sec.  
1910.1001(j) and Sec.  1926.1101(l).
Occupational Exposure To Hazardous Chemicals in Laboratories: 
Definitions
    OSHA proposed to modify most of paragraph (b), Definitions, in 
Sec.  1910.1450, Occupational Exposure to Hazardous Chemicals in 
Laboratories (the laboratory standard), in order to maintain 
compatibility with HCS. In particular, OSHA removed the definitions of 
Combustible liquid, Compressed gas, Explosive, Flammable, Flashpoint, 
Organic peroxide, Oxidizer, Unstable (reactive), and Water-reactive 
from paragraph (b). In addition, in the NPRM, OSHA revised the 
definitions of Hazardous chemical, Physical hazard, and Reproductive 
toxins in paragraph (b) and added definitions for Health hazard and 
Mutagen in paragraph (b). By these modifications to Sec.  1910.1450, 
the proposal sought to ensure that the definitions to the GHS-modified 
HCS also apply to the laboratory standard (Sec.  1910.1450). The 
modification 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).

    Ameren agreed with OSHA that ``combustible liquid'' should be 
removed from paragraph (b) (Document ID 0330). However, the 
company recommended that OSHA replace the term with specific flashpoint 
criteria. OSHA disagrees that a definition for combustible liquid with 
specific flashpoint criteria differing from GHS-modified HCS should be 
contained in the laboratory standard. OSHA's intention is to harmonize 
the laboratory standard with the GHS-modified HCS. The final HCS rule 
contains definitions of flammable liquids with flashpoint criteria in 
Appendix B, and these flashpoint criteria include what are currently 
the combustible liquid classes. The laboratory standard does not 
contain specific requirements for physical hazards, including flammable 
or combustible liquids. Rather, this program standard contains 
requirements for such things as a chemical hygiene plan, employee 
exposure determination, training, medical consultation and 
examinations, and recordkeeping. Thus, OSHA does not see a need for 
including separate flashpoint criteria for flammable or combustible 
liquids and believes that reference to the flammable liquid categories 
in HCS is appropriate for Sec.  1910.1450.
    OSHA proposed 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 to the final rule for 
the laboratory standard, 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 that preamble, 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 has thus incorporated in the final rule its proposed changes 
to the definitions in the laboratory standard.
Appendices
    OSHA reviewed the appendices to each of its substance-specific 
health standards and made the following minor changes necessary to 
align the appendices with their GHS-harmonized standards.
    The language in Appendix B, ``Employee Standard Summary,'' chapter 
XI, ``Signs,'' in both the general industry and the construction 
standards for lead (Sec.  1910.1025 and Sec.  1926.62, respectively) 
has been made consistent

[[Page 17753]]

with the language in their regulatory texts.
    In Asbestos Sec.  1910.1001, Appendix F, ``Work Practices and 
Engineering Controls for Automotive Brake and Clutch Inspection, 
Disassembly, Repair and Assembly (Mandatory),'' a reference to 
paragraph (j)(4) of the standard has been redesignated as paragraph 
(j)(5) to be consistent with the changes in the regulatory text for 
Sec.  1910.1001. No changes were made to the construction Asbestos 
standard Sec.  1926.1101, as none were needed.
Safety Data Sheets
    OSHA has changed the term ``material safety data sheets'' when it 
appears to ``safety data sheets'' in both the substance-specific health 
standards and their appendices. As discussed above, this change 
reflects the GHS terminology.
Compliance Dates for Substance-Specific Health Standards
    OSHA proposed to require implementation of all but one of the 
revisions to the HCS in three years following completion or 
promulgation of the final rule. Training was proposed to be required in 
two years. OSHA noted that during the transition period, an employer 
could be in compliance with either the current HCS or the revised HCS 
(the final rule), but there could not be a lapse in compliance. For the 
final standard, OSHA has decided to align implementation of GHS with 
the final implementation of GHS in the EU for labeling and SDSs. A full 
explanation of the information and comments and the Agency's reasoning 
is set out above in this section.
    The proposed changes to the substance-specific health standards 
required compliance with the HCS, thus incorporating the proposed 
compliance dates for the revised HCS. One commenter suggested that the 
proposed sign and label updates be done in accordance with the 
facility's normal replacement schedule (Document ID 0376). 
OSHA finds that this is too indefinite a period, because it essentially 
leaves the compliance date in the hands of each employer. OSHA has 
concluded that the administration of HCS programs by employers and the 
communication and comprehension of the hazards by employees will be 
most effective if the requirement for completion of changes for the 
substance-specific health standards is the same as for all other 
chemicals. In a sense, this is just another example of the consistency 
that was approved by so many of the commenters and hearing witnesses.
    Thus, the final rule keeps the compliance dates for the new 
substance-specific health standard requirements in line with those for 
the revisions to the HCS. Employers must be using new labels for 
contaminated clothing and waste and debris by June 1, 2015, the date by 
which manufacturers and importers must comply with the labeling and SDS 
requirements of the revised HCS. Employers must post the new signs by 
June 1, 2016, the same date by which employers must also update their 
hazard communication plans for any new hazard information they receive 
as a result of the final rule. In the meantime, as with the revised 
HCS, employers must comply with either the old or new labeling and 
signage requirements. Provisions to this effect are inserted for each 
substance-specific standard in this final rule.
Safety Standards
    OSHA proposed modifying safety standards that either directly 
reference the HCS or provide information pertinent to the SDSs, in 
particular regarding the storage and handling of chemicals. As noted 
above, many commenters supported standardizing physical hazard criteria 
across all applicable OSHA standards (Document ID 0034, 0104, 
0105, 0155, 0170, 0171, 0313, 0324, 0327, 0328, 0329, 0336, 0338, 0359, 
0365, 0376, 0382, 0395, 0405, 0408, 0410, and 0494 Tr. 91, 162). For 
example, the Compressed Gas Association (CGA) (Document ID 
0324) stated:

    CGA agrees with the harmonization to GHS 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 Hazard 
Communication Standard * * * or provide information pertinent to the 
SDS.

    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 of Highly 
Hazardous Chemicals (PSM) standard; and potential conflicts with widely 
accepted consensus standards (Document ID 0038, 0077, 0104, 
0163, 0329, 0335, 0336, 0339, 0366, 0370, 0381, 0383, 0393, 0399, 0414, 
0500, 0514, 0530, 0643, 0494 Tr. 91, 162, and 0497 Tr. 81-84).
    OSHA agrees with the commenters who supported standardizing 
physical hazard criteria and is doing so except in some standards, such 
as OSHA's electrical standards, where conflicts with referenced 
consensus standards make harmonization inappropriate at this time. OSHA 
proposed to:
     Incorporate the current HCS definitions of flammable 
liquid and gas into PSM and health hazard into Hazardous Waste 
Operations and Emergency Response (HAZWOPER) standards;
     Modify the Welding standard (Sec.  1910.252) requirements 
on labeling welding consumables to be consistent with GHS modifications 
to HCS;
     Amend paragraphs on flammable and combustible liquids to 
conform categories, terminology, flashpoints (FP), and boiling points 
to the GHS modifications to HCS;
     Incorporate the modified-HCS definition of flammable 
aerosols into the Flammable and Combustible Liquids standard, Sec.  
1910.106. (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); and
     Update the acceptable methods for determining flashpoints; 
but
     Leave unchanged electrical standards in Subpart S for 
general industry and Subpart K for construction, and explosive 
standards for general industry (Sec.  1910.109) and for construction 
(Sec.  1926.914).
    Commenters overwhelmingly supported ensuring consistency in OSHA 
standards, while maintaining scope of coverage. (Document ID  
0049, 0050, 0077, 0105, 0123, 0145, 0163, 0170, 0313, 0324, 0327, 0328, 
0351, 0359, 0365, 0376, and 0494 Tr. 91, 162). Organization Resource 
Counselors (ORC) (Document ID  0494 Tr. 91) testified:

    ORC supports concurrent harmonization of hazard definitions in 
most OSHA standards. ORC agrees with OSHA's proposal to harmonize 
hazardous communication components across most other OSHA standards 
in this rulemaking. ORC believes this is the most efficient way to 
address this necessary step in ensuring consistent hazard 
information and eliminating conflicting requirements.

    Many comments to the ANPR and the NPRM supported OSHA exempting 
certain standards such as electrical and explosive standards from 
harmonization at this time (Document ID  0047, 0075, 0076, 
0104, 0113, 0145, 0163, 0328, 0330, 0336, 0370, 0393, and 0408). For 
example, the standards in Subpart S contain requirements such as 
internal design criteria that, if changed, would impact their scope. 
OSHA's reasons for excluding these standards are explained below. In 
testimony at the hearing, the ACC (Document ID  0494 Tr. 162) 
agreed, stating:


[[Page 17754]]


    We agree with this approach and therefore would expect that 
there would be no impact on electrical area classification, facility 
[s]iting, mechanical integrity, electrical classification, storage 
quantities, unloading and storage location, ventilation 
requirements, spill protection, grounding and bonding, tank and 
vessel design, interlocks and safety devices and process hazard 
analysis.

    As discussed in detail below, in the final rule PSM retains its 
current scope; HAZWOPER's definition of ``health hazard'' is modified; 
the definitions in the Flammable and Combustible Liquids standards are 
aligned with the GHS modifications to HCS; Welding, Cutting and Brazing 
labeling requirements were also modified to be consistent with HCS; and 
a few technical amendments have been made to other safety standards 
that currently use the term ``combustible'' in order to keep their 
scope the same. Also, no changes were made to standards that OSHA 
proposed to exclude from this rulemaking.
PSM
    PSM standards for general industry and construction reference the 
HCS for their scopes, which are currently set forth in Sec.  
1910.119(a)(1)(ii) and Sec.  1926.64(a)(1)(ii) as covering a process 
which involves a flammable liquid or gas (as defined in Sec.  
1910.1200(c) [Sec.  1926.59(c)] on site in one location, in a quantity 
of 10,000 pounds (4535.9 kg) or more, followed by the listed exceptions 
in the paragraph.
    If OSHA did not modify this provision in this rulemaking, the scope 
of PSM would expand since the HCS's definition of flammable liquid 
changes from liquids with a flashpoint below 100 [deg]F (37.8 [deg]C) 
to the new GHS definition of liquids with a flashpoint at or below 
199.4 [deg]F (93 [deg]C) (though, as discussed above, the scope of the 
HCS is unaffected). Keeping the reference to the HCS definition would 
mean that many more processes would have been covered by the PSM 
standards than when those standards were promulgated. OSHA does not 
intend to expand the scope of the PSM standards. Therefore, to maintain 
the scope of those standards, OSHA proposed to modify the language in 
the scope paragraphs Sec.  1910.119(a)(1)(ii) and Sec.  
1926.64(a)(1)(ii) to read:

    A process which involves a Category 1 flammable gas (as defined 
in Sec.  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 * * *

    In other words, for PSM, ``flammable gas'' includes Category 1 
flammable gases and liquids only if they have flashpoints below 100 
[deg]F (37.8 [deg]C) to be consistent with the criteria specified in 
the current HCS.
    Commenters who considered the issue differed on what should be done 
(Document ID 0324, and 0402). For example, ACC, in responding 
the NPRM, supported OSHA's approach (Document ID  0393). ACC 
noted that OSHA's proposed regulatory language for Sec.  1910.119, the 
general industry PSM, appropriately reflected the new cut-off without 
changing the scope of the regulation (Document ID 0393). 
However, CGA requested that OSHA update paragraph (a)(1)(ii) of Sec.  
1910.119 to use GHS Category 1 flammable liquids as a cutoff for PSM 
coverage, stating, ``This would maintain consistency throughout the 
OSHA standards and harmonization with the GHS'' (Document ID 
0324). The Society of Chemical Manufacturers and Affiliates 
(SOCMA) (Document ID 0402) was concerned that the change in 
the flashpoint trigger for flammable liquids from ``the current 100 
[deg]F to the new 140 [deg]F * * * would significantly expand the 
number of products subject to OSHA 1910.106 (flammable liquids), and 
OSHA 1910.119 (Process Safety Standards).''
    While OSHA agrees with CGA that using GHS Category 1 flammable 
liquids would maintain consistency throughout the OSHA standards, to do 
so would change the scope of the PSM standard by making it applicable 
only to flammable liquids with flashpoints below 73 [deg]F (23 [deg]C). 
This would significantly narrow the scope of PSM and lessen worker 
protection by eliminating from coverage flammable liquids with 
flashpoints from 73 [deg]F to below 100 [deg]F. However, to set the 
coverage of PSM to 140 [deg]F (flammable liquid categories 1, 2 and 3 
which require the hazard warning ``flammable'' to appear on labels), as 
SOCMA noted, would expand the coverage beyond the scope of the original 
standard.
    OSHA has concluded that setting the flashpoint below 100 [deg]F 
(37.8 [deg]C), the previous HCS level, properly maintains the scope of 
the PSM standards as they were promulgated. As explained in the 
proposal, OSHA's approach to the other affected standards is to 
``modify provisions of the standards that reference the HCS definitions 
to maintain coverage or consistency with the modified HCS'' (74 FR 
50404, Sept. 30, 2009). It is beyond the scope of this rulemaking to 
consider whether, as a substantive matter, the scope of the PSM 
standards should be changed. Thus, OSHA is neither increasing nor 
decreasing the scope of the PSM standard; consequently, the same 
products in the same quantities will be covered. The final rule adopts 
the proposed changes to the PSM standards noted above.
HAZWOPER
    In the NPRM, OSHA updated the definition of health hazard in its 
HAZWOPER standards, Sec.  1910.120(a)(3) for general industry and Sec.  
1926.65(a)(3) for construction, so that the terminology is aligned with 
the GHS health hazards in Sec.  1910.1200, Appendix A. The final rule 
retains the proposed definition.
    In proposing this change, OSHA was concerned that some of the 
terminology in HAZWOPER, such as neurotoxin and nephrotoxin, which were 
partly defined by reference to the HCS, would no longer be consistent 
with the GHS-modified HCS. For consistency, the proposal removed such 
terms from HAZWOPER and are now subsumed within the HCS specific target 
organ toxicity category, thus maintaining the same hazard communication 
requirements in both HAZWOPER and HCS. By updating the definition of 
``health hazard'' in the HAZWOPER standards to clearly reference HCS, 
employers will have the proper reference to HCS and, in there, the 
proper guidance on how to classify the health hazards. OSHA received no 
contrary comment, and the final rule adopts the definition of health 
hazard as proposed.
    The ACC requested that OSHA clarify how the HAZWOPER standards 
would be affected by OSHA's adoption of the GHS flammable and 
combustible liquid classifications in Sec.  1910.106, Sec.  1926.152, 
and Sec.  1926.155 (Document ID  0393 and 0530). ACC seems to 
be asking why OSHA did not reference the new definitions (GHS 
categories) of flammable liquids in HAZWOPER. OSHA believes the 
HAZWOPER standards would not be directly affected by the GHS-harmonized 
categories of flammable liquids, and therefore ACC's concern is 
misplaced. The HAZWOPER standards are program standards, and they do 
not contain any specific references to flammable or combustible 
liquids. It is true that the HAZWOPER standards state that all 
requirements of Parts 1910 and 1926 of CFR title 29 apply to hazardous 
waste and emergency response (Sec.  1910.120(a)(2) and Sec.  
1926.65(a)(2)). Thus, where HAZWOPER-covered employees are responding 
to an emergency situation where flammable liquids have been stored or 
need to be temporarily stored during clean-up, the flammable liquid 
standards might apply. OSHA believes that even in those situations, GHS 
harmonization of flammable liquids will

[[Page 17755]]

have little or no effect on the HAZWOPER standards, because the 
substantive requirements of these standards have not significantly 
changed.
Welding, Cutting and Brazing--General Requirements
    OSHA is harmonizing the requirements in the Welding, Cutting and 
Brazing standard, Sec.  1910.252, by adding a Hazard Communication 
paragraph and bringing in line with the GHS and OSHA's substance-
specific health standards the terminology in the labeling requirements 
for filler metals and fusible granular materials, filler metals 
containing cadmium, and fluxes containing fluorine compounds.
    The final rule retains the proposed text of the Hazard 
Communication paragraph at Sec.  1910.252(c)(1)(iv). Similar to the 
substance-specific standards, the welding standard's hazard 
communication paragraph requires employers to include welding 
contaminants in a program established to comply with the HCS (Sec.  
1910.1200). Also, similar to the substance-specific standards, OSHA has 
added a date paragraph requiring employers to be using new labels by 
June 1, 2015, the date by which manufacturers and importers must comply 
with the labeling and SDS requirements of the revised HCS.
    In addition to adding the general Hazard Communication paragraph, 
OSHA reorganized some of the paragraphs in Sec.  1910.252 so as to 
place the general reference to HCS in the correct position in the 
standard, Sec.  1910.252(c)(1)(iv). To accomplish this, OSHA moved the 
``Additional considerations for hazard communication in welding, 
cutting, and brazing,'' including filler and fusible granular 
materials, materials containing cadmium, and materials containing 
fluorine compounds, from paragraphs (c)(1)(iv)(A) through (C) to new 
paragraphs (c)(1)(v)(A) through (D).
    The proposal inserted a cross reference to Sec.  1910.1200 in the 
welding standards hazard determination section. In addition, as with 
the substance-specific standards, the proposal deleted specific label 
language requirements for welding materials containing cadmium and 
fluorine and instead listed specific health endpoints to be considered 
in the classification.
    OSHA received one comment on the proposed changes from the Gases 
and Welding Distributors Association, Inc. (GAWDA). While GAWDA 
generally supported OSHA's rulemaking effort, GAWDA requested that OSHA 
change ``suppliers'' of welding materials to ``manufacturers'' in Sec.  
1910.252(c)(1)(v)(A) of the proposal (Document ID  0388). 
GAWDA stated the term ``supplier'' is undefined and might include 
different entities in the supply chain; furthermore, elsewhere OSHA 
places the responsibility of hazard determination on manufacturers, 
importers, and distributors. However, OSHA would like to point out that 
the term ``supplier'' is used in the current standard, which requires 
suppliers to determine the hazards in Sec.  1910.252(1)(c)(iv): ``The 
suppliers of welding materials shall determine the hazard, if any, 
associated with the use of their materials in welding, cutting, etc.'' 
OSHA assumes that ``suppliers'' will continue to use the same method 
that they are currently using to determine the hazards of their 
materials. To change this term could result in a substantive change in 
the scope of this standard and would be beyond the scope of this 
rulemaking. Therefore OSHA will retain the word ``suppliers'' as 
proposed.
    In addition, as discussed in the preamble to the proposal, See 74 
FR 50417 (Sept. 30, 2009), current Sec.  1910.252(c)(iv) does not 
merely require suppliers to determine the hazards of their products, 
but also to ensure that labels properly convey those hazards. A 
requirement that a supplier only determine the hazard of its products 
is of little value if they do not also convey information about those 
hazards on to the persons who use it. The final rule provides 
additional clarity that suppliers of welding products covered by the 
standard label as well as determine the hazard.
    The changes to this standard were predicated on achieving 
consistency with the GHS modifications to HCS and other OSHA substance-
specific standards, and OSHA has concluded that the modifications as 
proposed and as explained in the previous paragraphs will effectuate 
harmonizing the standard's terminology with HCS. In addition, this 
action also contributes to internal consistency by making the Welding, 
Cutting, and Brazing standard similar to the substance-specific health 
standards.
Flammable and Combustible Liquids
    OSHA proposed to align the definitions of flammable and combustible 
liquids in both the general industry and construction standards to 
conform to the GHS modifications to the HCS. In particular, the 
proposal changed the definitions of flammable liquid categories and 
deleted the term and definition of combustible liquids (See Table XIII-
6 for comparison of the GHS-modified HCS definitions and the current 
flammable and combustible definitions that were contained in 29 CFR 
1910.106 and 29 CFR 1926.155). OSHA has concluded that the proposed 
changes to the Sec.  1910.106 and Sec.  1926.155 definitions are 
reasonably necessary and appropriate and carried them forward into the 
final rule. In addition, to essentially maintain the scope of the 
standards, OSHA proposed, and is maintaining in the final rule, the 
addition of the flashpoint cut-off value where the GHS flammable liquid 
categories overlapped with the current HCS classes. The Alliance of 
Hazardous Materials Professionals and David Levine of Product Safety 
Solutions agreed, stating: ``The elimination of the term `combustible' 
and substitution of actual flash point data provide a more meaningful 
definition in the affected standards'' (Document ID  0313 and 
0327).
    OSHA proposed to drop the current rules' classifications of 
flammable and combustible liquids in favor of the GHS flammable liquid 
classifications. This meant that all liquids under the proposal would 
fall into GHS flammable liquid Categories 1 through 4, and that the 
term ``Combustible Liquids'' in Sec. Sec.  1910.106, 1910.107, 
1910.123, 1910.125, 1926.152, and 1926.155 was proposed to be deleted 
since the GHS does not have a hazard class titled ``Combustible 
liquids.'' However, the GHS does require the hazard statement 
``combustible liquid'' on the label for Category 4 Flammable liquids 
(flashpoint greater than 60 [deg]C (140 [deg]F) but not greater than 93 
[deg]C (199.4[deg]F)).
    In addition, the current general industry Spray Finishing standard, 
Sec.  1910.107, relies on the current Sec.  1910.106 definition of 
Class IIIB liquids (liquids with a flashpoint over 93 [deg]C). 
Therefore the proposal amends Sec.  1910.107 to replace its use of the 
term ``combustible liquids,'' which has no corresponding GHS category, 
with the phrase ``Liquids with a Flashpoint Greater than 93 [deg]C 
(199.4 [deg]F).'' With the new terminology, the protection provided by 
the original standards remains the same.
    OSHA believed that most of the proposed changes in the definitions 
were not significant. The move to GHS categories entails nominal 
changes to the flashpoint values for flammable and combustible liquids 
from 22.8 [deg]C (73 [deg]F) (current Class IA/B cut-off) to 23 [deg]C 
(73.4 [deg]F) (GHS Category 1/2 cut-off) and from 93.3 [deg]C (200 
[deg]F) (current Class IIIB cut-off) to 93 [deg]C (199.4 [deg]F) (GHS 
Category 4). OSHA believes these changes in flash point represent 
simple rounding to the closest significant value

[[Page 17756]]

and that they would have no significant effect on the scope of its 
standards or on employee safety. ACC agreed with OSHA, stating that 
``the elimination of the term `combustible liquid' in Sec.  1910.107 
does not significantly change the requirements of the standards and 
should not adversely affect industry's ability to comply with the 
standard'' (Document ID 0393). OSHA has concluded these new 
whole numbers are minute changes and that the rounded numbers coincide 
with GHS, are easier to understand and remember, and therefore will 
improve communication of hazards.
    However, OSHA requested comment in the proposal on one change that 
was potentially significant. Under the proposal, the boiling points 
used to define the threshold for the current Flammable Class IA in 
Sec.  1910.106 shifted from the cut-off value of 37.8 [deg]C (100 
[deg]F) to a cut-off value of 35 [deg]C (95 [deg]F) for GHS Category 1. 
Likewise, the boiling points in the proposed definition of Flammable 
Class IB (Sec.  1910.106) shift from equal to or greater than (>=) 37.8 
[deg]C (100 [deg]F) to greater than (>=) 35 [deg]C (95 [deg]F) in GHS 
Category 2 (See Table XIII-6). The Agency believed the changes would be 
necessary to make OSHA standards internally consistent and consistent 
with the GHS modifications to HCS. However, as discussed in the NPRM, 
OSHA was concerned that changing the boiling point cut-off for the 
highly flammable liquids 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, the 
proposal would allow a facility to use larger tanks to store liquids 
with boiling points between 37.8 [deg]C (100 [deg]F) and 35 [deg]C (95 
[deg]F). OSHA was concerned that this practice could decrease safety. 
OSHA 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 Flammable and Combustible Liquids Standard Class IA liquids on 
this list. OSHA was concerned that this was an instance where the 
benefits of harmonization could have been in conflict with the measure 
of safety currently provided and therefore requested comments on this 
issue.
    Most agreed with OSHA that resulting reclassifications of liquids 
with borderline flashpoints from the old Class IA to the GHS Category 2 
was not significant (Document ID 0313, 0324, 0327, 0328, 0338, 
0352, 0365, 0366, 0370, 0376, 0382, 0383, 0393, 0405, 0408, 0410, and 
0494 Tr. 56). National Association of Chemical Distributers (NACD) 
stated that ``Several NACD members handle flammable liquids under 
Category 1 and 2. However, the proposed changes would result in few 
operational changes'' (Document ID  0341). Several commenters 
pointed out that aligning the definitions for flammable liquids is 
consistent with the single worldwide definition for these hazards 
(Document ID 0313 and 0327). ORC (Document ID 0370) 
stated:

ORC agrees that the methods OSHA proposes to classify flammable 
liquids Category 1and 2 and flammable aerosols are similar enough to 
the current definitions 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.

The National Fire Protection Association (NFPA) (Document ID 
0366 and 0497 Tr. 56) stated:

NFPA agrees with OSHA's assessment regarding the slight adjustment 
resulting from the change in criteria for flash point and boiling 
point for flammable liquid categories when applying the GHS 
criteria. NFPA believes the overall impact of the changed flash 
point and boiling point will be negligible.

    The American Petroleum Institute (API) urged OSHA to be consistent 
across all standards (Document ID 0376). Further, the ACC 
commented that in reference to the boiling point cut-off for Category 1 
and 2 flammable liquids, they believe the language (in the NPRM) is 
sufficient to reflect the cut-off without changing the scope of the 
regulation (Document ID 0393).
    However, some commenters expressed concern that the shift in 
flammability criteria would require facilities to modify their storage 
facilities to maintain compliance with Sec.  1910.106, and consequently 
storage receptacles would have to be smaller, leading to less storage 
and greater costs (ISSA, Document ID  0399). That concern is 
misplaced because the change from OSHA's old flammable and combustible 
classes to GHS categories involves a lowering of the boiling point cut-
offs by 2.8 [deg]C (5.04 [deg]F), so that employers will still be able 
to use current handling and storage practices affected by the change. 
Likewise, current storage and handling practices for chemicals whose 
boiling points fall between 37.8 [deg]C and 35 [deg]C would still be 
allowed under the proposal. SOCMA commented that changing the 
definition would expand the number of products subject to Sec.  
1910.106 (Document ID 0402). That is also not correct. Due to 
the rounding of GHS flashpoints, cut-offs are slightly less stringent 
(See Table XIII-6) and no new chemicals would be regulated.

                                   Table XIII-6--Flammable Liquid Definitions
----------------------------------------------------------------------------------------------------------------
                              GHS                                Flammable and combustible liquids standard (29
---------------------------------------------------------------                   CFR 1910.106)
                                                               -------------------------------------------------
                                  Flashpoint     Boiling point                      Flashpoint     Boiling point
           Category                 [deg]C          [deg]C           Class            [deg]C          [deg]C
                                   ([deg]F)        ([deg]F)                          ([deg]F)        ([deg]F)
----------------------------------------------------------------------------------------------------------------
Flammable 1..................  <23 (73.4).....       <=35 (95)  Flammable Class  <22.8 (73).....     <37.8 (100)
                                                                 IA.
Flammable 2..................  <23 (73.4).....        >35 (95)  Flammable Class  <22.8 (73).....    >=37.8 (100)
                                                                 IB.
Flammable 3..................  >=23 (73.4) and  ..............  Flammable Class  >=22.8 (73) and  ..............
                                <=60 (140).                      IC Combustible   <37.8 (100).    ..............
                                                                 Class II.       >=37.8 (100)
                                                                                  and <60 (140).
Flammable 4..................  >60 (140) and    ..............  Combustible      >=60 (140) and   ..............
                                <=93 (199.4).                    Class IIIA.      <93.3 (200).
None.........................  ...............  ..............  Combustible      >=93.3 (200)...  ..............
                                                                 Class IIIB.
----------------------------------------------------------------------------------------------------------------


[[Page 17757]]

    The American Society of Safety Engineers (ASSE) agreed with OSHA's 
assessment of the storage issue. ASSE noted that the differences in 
boiling points from the original Sec.  1910.106 to the GHS Categories 
could increase the number of gallons allowed to be stored in rooms and 
cabinets as well as the size of containers for certain liquids. 
However, in its opinion, the ``slightly'' increased boiling point would 
be of ``little significance'' (Document ID 0336). Therefore, 
based on the analysis discussed above and the comments received, OSHA 
has concluded that the shift in boiling point and the minor changes in 
temperatures and the re-categorizing of flammable liquids are 
insignificant and will have a negligible impact on the protection 
provided by the standards that use these terms.
    Most commenters supported OSHA's proposal to incorporate the GHS 
definitions for flammable liquids into its safety standards (Document 
ID 0313, 0327, 0328, 0338, 0365, 0376, 0405, 0408, and 0410). 
Some stressed the ``consistency'' benefits from harmonization (Document 
ID 0338, 0405, and 0408). ASSE (Document ID 0336) 
said:

In response to OSHA's proposal 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 degrees F., 
ASSE believes this list of standards is appropriate. * * * However, 
ASSE urges OSHA to remove the term ``combustible liquid'' for all 
liquids and use the GHS criteria for all flammable liquids.

The National Paint and Coatings Association (NPCA), in supporting the 
removal of the term ``combustible liquid,'' noted that it was 
consistent with DOT (Document ID 0328).
    Although there was considerable support for the changes OSHA made 
in the proposal to the flammable and combustible liquid categories, 
OSHA also received comments suggesting that the deletion of the 
``combustible'' designation and the combining of NFPA Class 1C 
flammable and Class II combustible liquids into new Category Flammable 
3, would lead to confusion among engineers, employers, and employees, 
which could result in potential accidents (Document ID 0344, 
0366, 0381, 0399, 0402, 0498, 0500, 0514, and 0643). In addition, some 
commenters questioned whether the OSHA standards that address flammable 
liquids that are not covered by GHS (Combustible Class IIIB) are best 
handled by replacing the term ``combustible'' with a quantitative 
definition so as to maintain their coverage (Document ID 0336, 
0366, and 0497 Tr. 56-58 and 68).
    Some organizations, though they supported the proposed changes in 
general, had some specific concerns, particularly with how the OSHA GHS 
harmonization works with other national standards, including consensus 
standards. Clariant Corporation opined that eliminating the term 
``combustible liquid'' will likely cause some confusion since it is 
still used by NFPA and DOT but urged OSHA to adopt the GHS criteria to 
maintain global consistency (Document ID 0383). However, OSHA 
points out that, as mentioned above by NPCA, the GHS criteria are 
consistent with DOT. The American Federation of State, County and 
Municipal Employees (AFSCME) favored OSHA's GHS harmonization, but 
sought clarification or additional guidance on how secondary labeling 
systems such as NFPA's 704 Diamond or the Hazardous Materials 
Information System (HMIS) would be used once GHS was in effect 
(Document ID 0414).
    NFPA testified that the GHS categories would conflict with NFPA's 
established hazard ratings in NFPA 704, which has been in effect since 
the 1950s. NFPA recommended that the term ``combustible liquid'' not be 
deleted (Document ID 0497 Tr. 59-64). In addition, NFPA 
expressed concern that there may be additional confusion since the 
rating system in NFPA 704 expresses the most hazardous as a ``4'' while 
the GHS classification criteria expresses the most hazardous as 
Category ``1''. The International Fire Marshals Association (IFMA), 
echoing the sentiments of the NFPA, agreed that users have been relying 
on the NFPA 704 Hazard Rating and the Hazardous Material Information 
System (HMIS) systems for a long time and would be confused by the 
change (Document ID 0497 Tr. 80-84).
    These commenters were concerned that the proposed realignment of 
the flammable liquid categories would result in confusion among 
employees, emergency responders, authorities having jurisdiction, and 
others who have been used to the distinction between flammable and 
combustible liquids (Document ID 0344, 0366, 0381, 0399, 0402, 
0498, 0500, 0514, 0643, and 0497 Tr. 56-58). NFPA (Document ID 
0366) stated:

NFPA is also concerned with the elimination of the ``combustible 
liquids'' classification that will occur with the adoption of GHS as 
we believe there will be considerable confusion among the workers 
who have been instructed to take specific precautions for various 
liquids based on whether they were identified as ``flammable or 
combustible.'' Further, we believe that the elimination of the 
``combustible liquid'' classification may cause confusion among 
emergency responders and authorities having jurisdiction, who have 
until now understood that ``flammable liquids'' can be expected to 
be ignitable at ambient temperatures, while ``combustible liquids'' 
typically require some degree of heating to reach their flash point 
temperatures. This lack of definition may also be an issue, albeit 
to a lesser extent, among designers who have been trained to apply 
certain fire protection measures to ``flammable liquids'', but not 
to ``combustible liquids.'' The immediate recognition that has 
existed in the workplace for decades may be removed by the proposed 
rule; NFPA cautions OSHA that confusion among workers has the 
potential to be more significant than OSHA has acknowledged.

See also Document ID 0497 Tr. 56-58.

    As an initial matter, OSHA notes liquids with a flashpoint greater 
than or equal to 60 [deg]C (140 [deg]F) and less than 93.3 [deg]C (200 
[deg]F), which are currently classified as ``combustible,'' will be 
labeled as ``combustible liquids'' under the final rule. Thus this 
minimizes the potential for the confusion that NFPA suggests for these 
chemicals.
    In any event, OSHA believes that there is currently confusion and 
inconsistency in this area. For example, OSHA standards have several 
cutoff values for flammable and combustible liquids. In OSHA's general 
industry standard at Sec.  1910.106, 100 [deg]F is the cut-off between 
flammable liquids and combustible liquids, but in construction, Sec.  
1926.155, 140 [deg]F is the cut-off between flammable and combustible. 
Even the NFPA's standards are confusing. In NFPA 30, the hazard levels 
are structured from Ia/b/c to III b, with Ia being the highest, while 
in NFPA 704 the hazard levels range from 1 to 4, where the highest 
hazard category is 4 and the lowest is 1. NFPA classification and 
rating systems have been in existence since the 1950s and while the 
NFPA rating system is widely used, it is still not universally used or 
understood. Testimony from Mr. Frederick of the United Steelworkers 
indicated that NFPA is a good quick reference although (he believed) it 
does not cover all hazards, but it is used to alert workers that they 
must look elsewhere for additional information (Document ID 
0499 Tr. 155-169).
    In addition, OSHA reviewed randomly chosen SDSs for liquids 
classified under the current standard to determine how NFPA ratings 
correlated to hazard warnings. As shown in Table XIII-7, the hazard 
warnings were inconsistent, while the MSDSs were all technically 
correct for physical properties. For example, the hazard warning for 
flammable liquids with a

[[Page 17758]]

NFPA rating of 3 ranges from ``Flammable Liquid'' to ``Extremely 
Flammable'' to ``Severe.'' Notably, cyclohexanone, currently classified 
as a combustible liquid under Sec.  1910.106, bears the hazard 
statement ``Flammable.''

                      Table XIII-7--MSDS Communications of Flammable Liquid Hazard Warnings
----------------------------------------------------------------------------------------------------------------
        Docket             Chemical name         Flashpoint      NFPA rating listed    Hazard warning
----------------------------------------------------------------------------------------------------------------
0565...........................  Toluene............  40.7 [deg]F.......  3.................  Flammable Liquid
0566...........................  Turpentine.........  95 [deg]F.........  3.................  Flammable Liquid
0570...........................  Aliphatic            120 [deg]F........  None listed.......  Flammable Liquid
                                  Hydrocarbons.
0571...........................  Reagent N Hexane...  -22 [deg]F........  3.................  Extremely
                                                                                               Flammable
0567...........................  Paint Thinner......  104 [deg]F........  2.................  Combustible
0557...........................  Reagent Alcohol....  55 [deg]F.........  3.................  Severe (flammable)
0599...........................  Cyclohexane........  0 [deg]F..........  3.................  Extremely
                                                                                               Flammable
0560...........................  Cyclohexanone......  111 [deg]F........  2.................  Flammable
----------------------------------------------------------------------------------------------------------------

    OSHA believes that this rulemaking will promote greater 
harmonization of hazard warnings in the future. Now, when a chemical 
falls in a particular flammable liquid hazard category, the HCS 
requirements will dictate the appropriate hazard warning. At least one 
comment alleges this has already happened in the United States. Dr. 
Michele Sullivan pointed out that the U.S. Department of Transportation 
(DOT) is already aligned with the GHS physical hazard criteria (the GHS 
criteria for physical hazard was based on the DOT physical hazard 
criteria); thus is already aligned with GHS flammable liquid criteria. 
Therefore, OSHA is aligning with DOT with this rulemaking (49 CFR 
173.120 and Document ID 0382).
    Neither the proposal nor final rule prohibits the use of NFPA or 
HMIS rating systems. They do not prohibit the use of NFPA definitions 
for employers taking preventive measures in designing facilities or 
implementing fire protection systems such as automatic sprinklers to 
ensure a safer situation. OSHA's requirements, even with the 
substitution of the term ``flammable'' for ``combustible,'' do not 
prohibit safer workplace designs or installations. Furthermore, OSHA 
expects that engineers and other professionals will use the actual 
flashpoints and other properties of the liquids themselves in design 
and installation of controls rather than a designation of a liquid as 
``flammable'' or ``combustible.'' IFMA agreed with this premise 
(Document ID 0497 Tr. 84-85). In any event, even if the 
engineer, facility designer, or employer is somehow misled by Sec.  
1910.106's use of the term ``flammable,'' which has traditionally 
connoted a higher level of hazard, the result should be an error on the 
side of safety, rather than of less protection.
    During the public hearings, ORC Worldwide commented on OSHA's 
review of the standards affected by this rulemaking, stating support 
for the ``concurrent harmonization of hazard definitions in most OSHA 
standards.'' However, ORC also ``agrees with member concern that 
changes to definitions in Sec.  1910.106, Flammable and Combustible 
Liquids, while not increasing the scope of the standard, may cause 
confusion to workers who are familiar with NFPA nomenclature for these 
materials'' (Document ID 0494 Tr. 91-92). OSHA asked ORC to 
elaborate on this concern and provide support for their testimony. In 
response, ORC (Document ID 0643) provided two hypothetical 
situations it believes show that confusion over the realignment of 
flammable and combustible liquid categories could be significant:

Consider an engineer who is designing a new warehouse. (New) 
Category 3 liquids are to be stored therein, and these are liquids 
which were previously called ``combustible.'' Engineer does not 
design an electrical classification for the area. He does not 
realize that the new category may also include some liquids which 
are flammable. Because of this design outage, an electrical issue 
causes a fire and the warehouse burns down.
Consider a dry cleaning business that is using a (new) Category 3 
solvent and does not include automatic sprinklers because the team 
is familiar with this solvent as being ``combustible'' under the 
previous NFPA definitions. A different, more effective solvent is 
proposed, also (new) Category 3, and is accepted as being 
``similar''--the manufacturer reassures them that the new solvent is 
in the same flammability category as the previous one. But this one 
is indeed flammable and would require automatic sprinkler protection 
under NFPA rules. A fire starts with the new solvent, and because no 
automatic sprinklers exist onsite, the dry cleaner burns down.

    OSHA thanks ORC Worldwide for their testimony and for providing 
examples of where revisions to standards affected by this rulemaking 
might cause confusion. With regard to the situations presented by ORC, 
OSHA understands that the engineer designing the sprinkler system would 
be required to follow local and state building codes, along with NFPA 
codes or other building codes, such as NFPA 1 (Fire Code), NFPA 13 
(Standard for the Installation of Sprinkler Systems), NFPA 30 
(Flammable and Combustible Liquids Code), NFPA 32 (Standard for Dry 
Cleaning Plants), NFPA 5000 (Building Construction and Safety Code), 
and the International Building Code (published by the International 
Code Council) as well as any OSHA standards that would apply.
    The design of a system is not predicated on one physical property, 
and a prudent engineer or sprinkler designer should be aware that there 
are special requirements for the storage of combustible and flammable 
liquids. The codes and standards mentioned above all refer to NFPA 30 
for requirements related to the storage and use of flammable and 
combustible liquids. There are restrictions on maximum container size, 
maximum storage height, and maximum total quantity stored based on 
flashpoint.
    With regard to the change in solvent used at a dry cleaning 
facility, the argument remains the same as for the design engineer 
mentioned above. The flashpoint determines the classification of the 
chemical. The automatic sprinkler system design would be based on the 
flashpoint and not the class of chemical being used. OSHA concludes 
that commenters' concerns about confusion are not well founded and has 
decided to retain the GHS definition for flammable liquids as proposed 
in the final rule.
    Two commenters, Procter & Gamble and ISSA, believed OSHA was 
adopting the 140 [deg]F flashpoint cut-off as the definition of a 
flammable liquid and that this would conflict with the current 
flashpoint cut-off of 100 [deg]F in Sec.  1910.106 (Document ID 
0381 and 0399). Procter & Gamble, arguing that the GHS was 
designed for hazard communications and not intended to regulate design 
criteria and that aligning

[[Page 17759]]

the GHS criteria for flammable liquids in OSHA's safety standards would 
have unintended consequences (Document ID 0381), offered OSHA 
two options:

Option 1: Leave the current OSHA definition of flammable liquids 
unchanged. This is easy, clear, and no-cost to U.S. industry.
Option 2: In principle, GHS is a labeling and hazard communication 
system, and was not intended to regulate the design and operation of 
facilities. OSHA 1910.106, by comparison, is a risk management 
regulation used in such design and operation. If OSHA adopts the GHS 
Building Block of 140 [deg]F, leave the parallel definition of 100 
[deg]F intact in 1910.106. This dual system will create some 
confusion, but will minimize the negative effects listed above.

    As an initial matter, Procter & Gamble misunderstood how OSHA 
incorporated the GHS flammable liquid definitions into the safety 
standards. This change was made only to align terminology. In fact, 
OSHA agrees that the GHS was not intended to regulate design criteria. 
Therefore, OSHA proposed to leave the standard's design criteria intact 
by using the actual measurable flashpoint as the defining criterion. 
The proposal, adopted by the final rule, is similar to Procter & 
Gamble's Option 2 and accomplishes both harmonization with GHS and 
retention of OSHA's long-established and effective risk management 
practice.
    Finally, there were concerns that realigning the flammability 
criteria could affect contracts. Phylmar Regulatory Roundtable (PRR), 
which did not oppose OSHA's alignment of definitions of flammable and 
combustible liquids with the GHS categories, was concerned the 
reclassification of chemicals may cause conflicts in contracts with 
customers. PRR stated that the contracts require specifications in 
products manufactured, engineering controls, personal protective 
equipment, and specified instructions. PRR claimed that in such a 
situation the manufacturer by contract is permitted no deviation from 
the contract or process standards (Document ID 0514). However, 
as stated above, OSHA has not changed the scope or the requirements of 
its standards. Therefore, OSHA has concluded there is unlikely to be 
any interference with contracts. Moreover, where distinctions must be 
made in the OSHA requirements between the former Class 1C flammable 
liquids and Class II combustible liquids, the OSHA requirements have 
specified such distinctions with specific flashpoints. The contents and 
scopes of the regulatory paragraphs are not affected by GHS 
reclassifications or terminology changes, nor are OSHA's ventilation, 
respiratory protection, and personal protective equipment standards. In 
addition, OSHA did not change standards, like its electrical standards, 
that address internal design criteria.
    OSHA has decided to remain consistent with GHS and not create 
additional flammable liquid categories. However, Sec.  
1910.106(18)(ii)(b) defines Combustible Class IIIB liquids as liquids 
with flashpoints at or above 200 [deg]F (93.3 [deg]C). While Class IIIB 
liquids are not included in the scope of Sec.  1910.106, there is no 
such exemption in the Spray Finishing standard, Sec.  1910.107 (OSHA 
letter of interpretation, Aug. 15, 2006). In order to preserve coverage 
in standards such as Spray Finishing, these liquids are now called 
``Liquids with a Flashpoint of >93 [deg]C (199.4 [deg]F).'' Similar to 
Sec.  1910.106, the use of the flashpoint cut-off is the best way to 
stay as close to the GHS and maintain scope and consistency within the 
standards. The Soap and Detergent Association (SDA) and the Consumer 
Specialty Products Association (CSPA) in a joint comment stated that 
OSHA should ``correct'' Sec.  1910.107(e) and (e)(4) and Sec.  
1910.124(c)(2) to read ``Liquids with a Flashpoint at or below 199.4 
[deg]F'' to be consistent with the GHS criteria (Document ID 
0344). However, if OSHA were to adhere strictly to GHS in this 
instance and drop the higher flashpoint category, protection from this 
hazard would be lost and safety compromised.
    Several commenters addressed this issue. ASSE stated that their 
``members do not see the need for the fifth category of `Flammable 
Liquids Over a Flash Point of 93.3 [deg]C.' Specific flash point 
criteria should be used'' (Document ID 0336). NFPA expressed 
general concern about the elimination of the Class IIIB liquids by the 
adoption of the GHS categorization system, though they acknowledged 
that OSHA had proposed to extend liquids as ``flammable liquid with 
flash point greater than 93 [deg]C'' (Document ID 0366 and 
0497 Tr. 56-58). The point was further clarified upon questioning at 
the hearing where NFPA agreed that by extending the liquids to 
flashpoints greater than 199.4 [deg]F, OSHA was providing the coverage 
for Sec.  1910.107 that had always been there. In addition, NFPA 
recommended it be further clarified that these liquids with the higher 
flashpoints belong to Sec.  1910.107 and are not part of GHS Category 4 
(Document ID 0497 Tr. 68).
    In addition, Intercontinental Chemical Corporation recommended that 
OSHA create six new categories matching the six classes in the original 
Sec.  1910.106 (Document ID 0500). The Agency believes that 
this approach would be inconsistent with GHS, since the GHS 
classifications and categories, including flammable liquid Categories 
1-4, were established by international committees and are in place. 
OSHA's intent in this rulemaking is to harmonize the HCS with the 
existing GHS classifications and categories, not to make new 
categories.
    In summary, OSHA views this rulemaking as a step towards 
eliminating current inconsistencies. OSHA believes the potential 
confusion with other agency policies, standards, consensus standards, 
and traditional practices suggested by the commenters are not likely to 
occur for several reasons. First, the changes in the final rule will 
bring internal consistency to the OSHA standards covered. OSHA 
standards currently have several cut-off values for flammable and 
combustible liquids. In OSHA's general industry standard (Sec.  
1910.106), 100 [deg]F is the cut-off between the flammable and 
combustible liquids, but in construction, Sec.  1926.155, 140 [deg]F is 
the cut-off between flammable and combustible. Harmonizing these 
standards, which have been out of sync for many years, will bring 
needed consistency to the safety standards. In addition, as noted 
above, substantive requirements have not changed, and therefore designs 
are not affected.
    Second, the changes to the standards do not require changes in work 
practices. Rather, what have changed are a few regulatory terms used in 
the standards. Commenters who thought that such changes in definitions 
and terminology would result in significant and costly modifications to 
facility design and operation are incorrect, as the old requirements in 
the standards remain and no facility design and operation changes are 
required (Document ID 0344, 0381, and 0399). The requirements 
for what were known formerly as combustible liquids remain the same 
even though they are now categorized as flammable liquids.
    Third, there is growing awareness of the GHS ``flammable liquids'' 
definition. Other agencies, such as DOT, are already aligned with the 
GHS definition for flammable liquids (49 CFR 173.120), and OSHA 
believes that its ANPR and NPRM have raised awareness of the 
definition.
    Change occurs in every area of employment, and employers and 
workers get trained and adjust to the change; OSHA believes these minor 
changes will be accepted and adopted. OSHA's flammable and combustible 
liquid storage requirements have always been based on the flashpoint 
and boiling point of the liquid; OSHA does not

[[Page 17760]]

believe that facility designs rely on whether the liquid is labeled as 
flammable or combustible. (See Document ID 0497 Tr. 84-85) 
Thus, OSHA has concluded that the allegations of impacts on facility 
design and operations are perceptual rather than actual. This is 
especially true in light of the fact that certain OSHA standards were 
exempted from the terminology changes if these changes were to affect 
internal design criteria of any area of the workplace. OSHA has 
therefore concluded that the proposed changes to the Sec.  1910.106 
definitions are reasonably necessary and appropriate and has carried 
them forward into the final rule.
    OSHA will be doing outreach to affected parties and working with 
professional and trade associations to help users become familiar with 
and competent in applying these modifications. ORC testified that the 
changes may cause confusion to workers familiar with NFPA nomenclature, 
and agreed with OSHA that, with training, any confusion resulting from 
the change from NFPA definitions and terminology to GHS definitions and 
terminology would be overcome. ORC (Document ID 0494 Tr. 100-
101) further stated that potential confusion would not be a reason to 
delay moving forward with finalizing the standard:

There's a significant problem with lack of harmonization of chemical 
control approaches in the United States, and we would like to see, 
as we said in our testimony, some sort of formalization because we 
think it's the only thing that's going to work here, formalization 
of regular contacts between the NFPA and OSHA.

Mike Wright, representing the United Steelworkers (Document ID 
0494 Tr. 76-77), put it succinctly, stating:

The whole point of harmonization is to reconcile different 
standards, which may be conflicting. That means something has to 
change. * * * Ultimately, in the short term will there be some 
confusion? Yes. Can we minimize that through good training, through 
good information? Yes, and we ought to, but ultimately I think we 
have a globally harmonized system that's been adopted on a worldwide 
level and then we have various national organizations--very 
important ones like the NFPA--which may deviate in the way they 
communicate hazards from that globally harmonized system.
With respect to my friends at the NFPA, who I think do wonderful 
work, I think their job is to harmonize their system to the Globally 
Harmonized System. We hope that happens as soon as possible, and I'm 
confident that it will.
You know, ultimately we need to go to one * * * system worldwide. We 
have that system now. It will take some time and a little bit of 
confusion to conform every other kind of national voluntary system 
to that, but that work has to be done.

    OSHA agrees and believes users of the new GHS flammable liquid 
categories will implement its new terminology in their work.
Minor Safety Standard Changes
    The note in the PSM construction standard, Sec.  
1926.64(d)(1)(vii), has been changed. In the current standard, 
paragraph (d)(1)(vii), the note states, ``Material Safety Data Sheets 
meeting the requirements of 29 CFR 1926.59(g) may be used to comply 
with this requirement to the extent they contain the information 
required by this subparagraph.'' The note has been changed to ``Safety 
Data Sheets (SDSs) meeting the requirements of 29 CFR 1910.1200(g) . * 
* *''
    To correct a technical error and to complete alignment across 
standards, Sec.  1910.106(j), Scope, has been made consistent with 
Sec.  1910.106(a)(19) and Sec.  1910.1200, Appendix B. Proposed Sec.  
1910.106(j) stated that it ``applie[d] to the handling, storage, and 
use of flammable liquids with a flashpoint below 199.4 [deg]F (93 
[deg]C) unless otherwise noted.'' (Emphasis added). Final Sec.  
1910.106(j) is now consistent with Sec.  1910.106(a)(19) and Sec.  
1910.1200 in that it applies to ``* * * flammable liquids with a 
flashpoint at or below 199.4 [deg]F (93 [deg]C) * * *'' (Emphasis 
added).
    In Sec.  1926.155, OSHA proposed to harmonize the definitions of 
flammable and combustible liquids to be consistent with the GHS 
categories of flammable liquids (i.e., the updating of the definition 
of flammable liquids and the removal of the definition for combustible 
liquids), and this change is carried through to the final rule. The 
final rule also removes ``or combustible'' in the other standards in 
Subpart F, to maintain consistency with the ``Definitions'' in Sec.  
1926.155. In Sec.  1926.150(c)(vi), which currently states, ``A fire 
extinguisher, rated not less than 10B, shall be provided within 50 feet 
of wherever more than 5 gallons of flammable or combustible liquids or 
5 pounds of flammable gas are being used on the jobsite,'' the term 
``or combustible'' has been removed. Likewise, the Agency is correcting 
Sec.  1926.151(b)(3) by removing ``or combustible.'' In Sec.  
1926.151(a)(4), Portable battery powered lighting, which states that 
``the storage, handling, or use of flammable gases or liquids, shall be 
* * * approved for the hazardous locations,'' the term ``flammable 
liquids'' has been changed to ``Category 1, 2, or 3 flammable 
liquids.'' This change maintains the scope set by the flashpoint ranges 
for the Subpart (as defined by the original Sec.  1926.155 paragraphs 
(c) and (h)).
    The Soap and Detergent Association and Consumer Specialty Products 
Association, in a joint comment (Document ID 0344), suggested 
that OSHA change the term ``pilot light'' to ``indicating light.'' As 
discussed previously, this type of change is outside of the scope of 
this rulemaking since it does not pertain to hazard communication or 
GHS harmonization. Therefore, OSHA is not adopting that suggestion at 
this time.
Methods To Determine Flashpoints
    OSHA proposed to update the methods that may be used to determine 
flashpoints in the NPRM. These methods include updated ASTM methods, 
ISO methods, and British, French, and German national standards for the 
testing. The methods are listed in Appendix B.6 of Sec.  1910.1200 and 
are also referenced in Revision 3 of the GHS (2009), Chapter 2.6.
    In the definitions of Sec.  1910.106, the current standard allowed 
only ASTM D-56-70 and ASTM D-93-71 as testing methods to determine 
flashpoints. In Sec.  1926.155, which applies to Subpart F of the 
construction standards (Fire Protection and Prevention), OSHA currently 
allows only ASTM D-56-69 and ASTM D-93-69 for such determinations. The 
current HCS allows only ASTM D 56-79, ASTM D 93-79, and ASTM D 3278-78. 
The methods allowed in Sec.  1910.155 were adopted in the late 1960s, 
and the methods for Sec.  1910.106 and Sec.  1926.1200 were adopted in 
the 1970s.
    The NPRM updated the methods in Sec.  1910.1200 to conform to the 
GHS. However, flashpoint methods in Sec.  1910.1200 had always differed 
from methods in Sec.  1910.106 and Sec.  1926.155. Instead of revamping 
the older test methods in OSHA's other standards, the proposal allowed 
a broader test selection. OSHA kept the tests currently permitted in 
Sec.  1910.106 and Sec.  1926.155 because they were in the original 
OSHA standards, but allowed methods in the GHS-modified HCS be used as 
well. The final rule adopts these changes.
    Thus, the final rule amends Sec.  1910.106 and Sec.  1926.155 to 
allow ASTM D-56-70 and ASTM D-93-71 for Sec.  1910.106; ASTM D-56-69 
and ASTM D-93-69 for Sec.  1910.155; and the equivalent testing methods 
permitted in the HCS, Sec.  1910.1200, Appendix B.6, Physical Hazard 
Criteria. For example, as amended by the final rule, Sec.  
1910.106(a)(14)(i) states that for a liquid which has a viscosity of 
less than 45 SUS at 100 [deg]F (37.8 [deg]C), does not

[[Page 17761]]

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, or an 
equivalent test method as defined in Appendix B to Sec.  1910.1200--
Physical Hazard Criteria, must be used.
    By equivalent test method, OSHA means employers can select any of 
the test methods in Appendix B.6 or in Chapter 2.6 of Revision 3 of the 
GHS (2009).
    The only comments on this issue recommended additional methods for 
determining flashpoints (Document ID 0344 and 0381). The Soap 
and Detergent Association/Consumer Specialty Products Association 
(Document ID 0344) and the Procter & Gamble Company (Document 
ID 0381) recommended OSHA include ASTM D6450 on the list of 
approved methods for determining the flashpoints of liquids in the 
``incorporation by reference'' list in Sec.  1910.106. OSHA is not 
prepared to adopt this method at this time. The determination of 
flashpoint test methods for GHS falls under a Sub-committee of the 
United Nations Economic and Social Council's Committee of Experts on 
the Transport of Dangerous Goods (UNCEDTG). Commenters who wish the GHS 
to incorporate ASTM D6450 should direct their requests to that body, 
and if the method is incorporated into the GHS, OSHA will consider the 
matter at that time.
Flammable Aerosols
    OSHA currently defines the term ``flammable aerosol'' in Sec.  
1910.106 and in Sec.  1910.1200 by reference to a definition developed 
by the Consumer Product Safety Commission under the Federal Hazardous 
Substances Act. See 16 CFR 1500.45; See also 15 U.S.C. 1261(l). The 
current HCS defines flammable aerosol as 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.
    The current Sec.  1910.106 definitions for ``aerosol'' and 
``flammable aerosol'' are provided in (Sec.  1910.106(a)(1)) and (Sec.  
1910.106(a)(13)) and are different from those in the revised Hazard 
Communication Standard. In the current Sec.  1910.106, an aerosol is 
defined as a material which is dispensed from its container as a mist, 
spray, or foam by a propellant under pressure. However, in the current 
Sec.  1910.106, a flammable aerosol is defined as 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 Sec.  
1910.106(d), such aerosols are considered Class IA liquids.
    OSHA proposed to remove the definitions of ``aerosol'' and 
``flammable aerosol'' from Sec.  1910.106 and instead insert its GHS-
consistent definitions along with references to Appendix B.3 of the 
GHS-modified HCS. In response to OSHA's proposed action, National Paint 
and Coatings Association and Alliance of Hazardous Materials 
Professionals both said that, while they were not prepared to offer 
specific impact information on operations, ``to align OSHA definitions 
for * * * Flammable Aerosols is fully consistent with the concept of a 
`single world-wide' definition for these hazards.'' (Document ID 
0313 and 0327).
    OSHA agrees with these comments and has included the revised 
definition of ``flammable aerosols'' in the final rule. The revised 
definition in the Flammable liquids standard, Sec.  1910.106, 
duplicates the flammable aerosols definition contained in Appendix B to 
Sec.  1910.1200--Physical Hazard Criteria. For the purposes of Sec.  
1910.106(d), such aerosols are considered Category 1 flammable liquids.
    The GHS-modified definition and classification criteria for 
flammable aerosols can be found in Appendix B.3 of HCS.
    OSHA's decision to change the definition of aerosols to be 
consistent with the GHS-modified HCS is based not only upon harmonizing 
its own standards with those followed by other countries who have or 
are considering adopting GHS, but also to harmonize with DOT's 
definition for flammable aerosols, which is also consistent with the 
GHS. See 49 CFR 173.115(k).
    Dr. Michelle Sullivan (Document ID 0382), alluding to 
flammable aerosols, pointed out that flammable categories will differ 
among regulatory authorities. She stated:

[T]he GHS flammable aerosol criteria are linked to the criteria for 
flammable liquid, flammable solid and flammable gas, the flammable 
aerosol criteria depend on the hazard categories/building blocks of 
these other hazards * * * some regulatory authorities will adopt 
categories 1-4 while others will adopt categories 1-3 * * * [and 
thus] * * * the flammable aerosol criteria will differ for these 
regulatory authorities.

    Regarding Dr. Sullivan's comment, OSHA acknowledges that other 
regulatory bodies, when adopting GHS, may choose different building 
blocks. However, the basis for classification will still be based on 
the same criteria and will lead to harmonization of similarly covered 
materials. This does not affect OSHA's decision to strive for both 
domestic and international harmonization.
    Finally, OSHA believes that the GHS classification criteria are 
similar enough to the current Sec.  1910.106 and Sec.  1910.1200 
criteria that all aerosols currently regulated by OSHA would continue 
to be so, and that few, if any, new aerosols would be subject to OSHA 
regulation. Indeed, OSHA raised this issue in the NPRM and received no 
comments to the contrary.
Standards Not Included in This Rulemaking
    OSHA did not propose 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 the HCS for 
applicable scope or incorporation into the SDS. These standards include 
Subpart S--Electrical, in Part 1910 (General Industry), and Subpart K--
Electrical, in Part 1926 (Construction). Many commenters on the ANPR 
were particularly concerned that a change in OSHA's definitions would 
create an incompatibility with local building codes (Document ID 
0047, 0075, 0076, 0104, 0113, 0145 and 0163). They alleged 
that, 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.
    Many commenters on the NPRM supported OSHA's exemption of these 
standards (Document ID 0328, 0330, 0336, 0370, 0393, and 
0408). Ameren expressed concern that if OSHA harmonized the electrical 
and blasting agents standards (Part 1910 Subpart S, Sec.  1910.109, and 
Part 1926 Subpart K, Sec.  1926.914) with the GHS, such changes would 
require training of affected employees on the changes (Document ID 
0330). ASSE agreed with OSHA's decision not to propose updates 
to the electrical standards (general industry 1910 Subpart S and 
construction 1926 Subpart K) or explosives and blasting agents (general 
industry Sec.  1910.109 and construction Sec.  1926.914), since 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) 
(Document ID 0336). The American Iron and Steel Institute 
agreed (Document ID 0408). ORC strongly

[[Page 17762]]

supported OSHA's approach of not updating these standards but waiting 
until the referenced external organizations adopted the GHS elements 
(Document ID 0370).
    Wacker Chemical Company, PRR, and ACC urged OSHA to update 
electrical and explosive and blasting agents standards if the consensus 
organizations could come to agreement, and they expressed their 
concerns regarding potential conflicts with local codes and regulations 
(Document ID 0335, 0339, and 0393). Wacker Chemical 
Corporation encouraged OSHA to work closely with organizations (NFPA 
and others) that develop fire and electrical codes to ensure there is 
consistent application of these codes to area classification, building 
construction, equipment electrical ratings, etc. (Document ID 
0335). Wacker Chemical suggested that OSHA could make progress 
with the consensus organizations (Document ID 0335). PRR 
recommended harmonization updates of electrical and explosive standards 
if the updates would enhance safety and the ease of doing business in 
the global market (Document ID 0339). The ACC agreed with 
OSHA's decision not to change standards that incorporate consensus 
standards by reference (i.e., design criteria) (Document ID 
0393). ACC requested OSHA clarify in its final rule that 
harmonization would not affect the International Building Code and the 
International Fire Code such that users will not be unduly required to 
upgrade buildings to conform to requirements for hazardous occupancies. 
By its decision regarding standards not included in this rulemaking, 
OSHA is making it clear that upgrading buildings is not within the 
scope of this rulemaking.
    OSHA agrees with those comments that expressed the desire to 
harmonize but also expressed concern over the potential effects of 
internal codes. OSHA concluded that exempting those standards where 
conflicts with internal codes could occur at this time was appropriate. 
OSHA agrees with ACC that impacting electrical area classification, 
facility siting, and wiring configuration is not appropriate. 
Therefore, because of these potential conflicts with internal design 
criteria, OSHA is not harmonizing the electrical and other standards 
that depend on internal design criteria and local building codes.
Explosives and Blasting Agents
    OSHA did not propose to harmonize the Explosive and Blasting Agents 
standards, Sec.  1910.109 (general industry) and Sec.  1926, Subpart U 
(construction). At the time of the proposal, a separate rulemaking to 
revise them was in progress. That rulemaking has since been terminated 
(75 FR 5545, Feb. 3, 2010). However, the HCS has always covered 
hazardous chemicals regulated by OSHA's Explosive and Blasting Agents 
standards. Although the rulemaking on explosives and blasting agents 
has ceased, the general requirements in the GHS-modified HCS and 
specific requirements in its appendices still apply to explosives and 
blasting agents that can be considered hazardous chemicals. 
Manufacturers and importers must evaluate chemicals to classify their 
health and physical hazards in accordance with paragraph (d) of the 
HCS, must affix labels in accordance with paragraph (f) in HCS, and 
must provide SDSs in accordance with paragraph (g) of the HCS. Appendix 
B.1 of the GHS-modified HCS contains specific classification criteria 
for explosives. Furthermore, labels are required by the Department of 
Transportation (DOT) for the transportation of packages or containment 
devices that contain hazardous materials meeting one or more of DOT's 
hazard class definitions. See 49 CFR Part 172 Subpart E. In addition, 
OSHA's general industry standard Sec.  1910.1201, ``Retention of DOT 
markings, placards, and labels,'' requires that DOT labels, placards, 
or markings be retained under certain conditions. Thus, explosives and 
blasting agents are already covered by the GHS-modified HCS and Sec.  
1910.1201.
    The few commenters who addressed the issue supported OSHA's 
decision not to include the Explosive and Blasting Agents standards 
(Sec.  1910.109 and Sec.  1926.914) in the proposal (Document ID 
0328, 0330, 0336, 0362, and 0370).
    As to the continuing coverage of HCS, a representative from 
Institute Makers of Explosives stated that the commercial explosives 
industry understands the importance of GHS, has been prepared for 
several years to implement GHS, and would not experience any impacts to 
explosives operations that were not already anticipated (Document ID 
0362).
    Galaxy Fireworks noted that Sec.  1910.109(k)(1) excludes the sale 
and ``use (public display)'' of pyrotechnics (fireworks) from the 
explosives standard (Document ID 0355). Galaxy Fireworks' 
concern was the potential for the proposal to create a regulation that 
overlaps with the existing requirements of the Department of 
Transportation and the Consumer Product Safety Commission. Galaxy urged 
OSHA to work with these other agencies in amending the HCS to develop 
regulations that would apply uniformly to the fireworks industry and 
with other organizations to further harmonization (Document ID 
0335). OSHA agrees and believes its global harmonization 
efforts embodied in this rulemaking go a long way toward the overall 
goal of consistency.
Maritime
    OSHA received one comment, from Northrop Grumman Shipbuilding, 
which stated that OSHA had omitted modification of the shipyard Part 
1915 safety standards for GHS harmonization (Document ID  
0395). More specifically, Northrop Grumman believed that the maritime 
standards that contain requirements for flammable and combustible 
liquids required review and updating to be GHS harmonized, just as the 
flammable and combustible liquids the General Industry Part 1910 and 
Construction Part 1926 standards were proposed to be reviewed and 
updated.
    OSHA did not propose to update the maritime standards, other than 
the substance-specific standards mentioned above, in this rulemaking. 
Unlike the standards in general industry and construction, the maritime 
standards (Shipyard Employment, Part 1915; Marine Terminals, Part 1917; 
and Longshoring, Part 1918) have always addressed flammables and 
combustibles in their own unique way, reflecting the special conditions 
of maritime work. These parts do not use flashpoint criteria to 
distinguish between flammable and combustible liquids. The terminology 
in the maritime standards that addresses flammable and combustible 
materials, including liquids, differs from the general industry and 
construction standards. For example, Sec.  1915.12(b)(1) (Flammable 
atmospheres) and Sec.  1915.54 (Welding, cutting and heating of hollow 
metal containers not covered by Sec.  1915.12) require competent-person 
testing and contain detailed instructions on the specific maritime work 
covered.
    There are a few paragraphs in the maritime standards where 
flammable and combustible liquids requirements reference flashpoint 
criteria but in these cases, flashpoints are not used for the purpose 
of distinguishing flammable from combustible liquids. Examples include 
Subpart P, Fire Protection, Sec.  1915.501 through Sec.  1915.509, 
where flammable liquid is defined as liquids with flashpoints below 100 
[deg]F (37.8 [deg]C). Combustible liquids are neither defined nor 
mentioned in this Subpart, although combustible materials are mentioned 
and not defined. Other maritime standards such as Sec.  1915.14 (Hot 
work)

[[Page 17763]]

and Sec.  1915.35 (Painting) specify flashpoints for certain 
requirements, but these are not distinctions of flashpoints defining 
flammable or combustible liquids. The final rule does not modify these 
criteria.
    OSHA has issued a maritime compliance tool, ``Tool Bag Directive 
for the Part 1915 Shipyard Employment Standards,'' that includes 
specific interpretations of the maritime standards. The Tool Bag 
Directive references specific general industry standards in order to 
provide further guidance related to some of the more general maritime 
requirements. A specific case is how general industry standard Sec.  
1910.106 is used. The Tool Bag Directive informs users that if specific 
Part 1915 shipyard requirements give flashpoint criteria, those 
requirements take precedence. However, where definitions of flammable 
and combustible liquids are not specified in the Part 1915 shipyard 
standards, the definitions of Sec.  1910.106 are to apply. The final 
rule's changes do not significantly modify the substantive requirements 
of Sec.  1910.106, and the Tool Bag Directive's interpretive policy 
will continue after the final rule becomes effective, using the new 
definitions in Sec.  1910.106.
    In a similar manner, OSHA has a compliance tool for Parts 1917 
``Marine Terminals'' and 1918 ``Longshoring'' called the Tool Shed 
Directive. This Directive notes that the requirements of Sec.  
1910.1200 apply to operations covered by Parts 1917 and 1918. See also 
1917.1(a)(2)(vi); 1918.1(b)(4). Therefore, all the requirements in the 
GHS-modified HCS (Sec.  1910.1200), and its appendices will apply to 
the maritime industry. In addition, part 1910 applies to marine 
terminal operations that fall within the exception found at Sec.  
1917.1(a)(1)(i): ``facilities used solely for the bulk storage, 
handling, and transfer of flammable, non-flammable, and combustible 
liquids and gases.'' The final rule's changes to Sec.  1910.106 will 
therefore apply to facilities handling flammable and combustible 
liquids that fall within this exclusion, but again, as explained above, 
the substantive requirements of Sec.  1910.106 have not changed 
significantly.
Construction
    The Building and Construction Trades Department (BCTD) requested 
that OSHA clarify inconsistencies in the construction standards, 
particularly by updating the Part 1926 standards to conform to the 
proposed requirements for and definitions of ``flammable'' and the 
related deletion of the term ``combustible'' liquids (Document ID 
 0359). BCTD gave examples of Sec. Sec.  1926.152, 1926.155, 
1926.66 and Subpart K of Part 1926 and requested that OSHA conduct a 
thorough review of the Part 1926 construction standards. Though it had 
done so once in preparing the NPRM, OSHA again conducted a thorough 
review of Part 1926. OSHA had already proposed to modify Sec.  1926.152 
(Flammable and combustible liquids) and Sec.  1926.155 (Definitions) as 
well as Sec.  1926.64 (Process Safety Management), Sec.  1926.65 
(HAZWOPER), and the substance-specific health standards in construction 
in the NPRM. As explained above, OSHA has made further revisions in the 
construction regulations regarding process safety management (Sec.  
1926.64(d)(1)(vii)) and fire protection and prevention (Sec.  
1926.150(c)(vi), Sec.  1926.151(a)(4)), and Sec.  1926.151(b)(3)) in 
this final rule.
    Like Subpart S in general industry, Sec.  1926.66 (Criteria for 
design and construction of spray booths) belongs to the category of 
construction standards that incorporate other consensus standards by 
reference, 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. Clearly, there is no reason to change the terminology in Sec.  
1926.66. As noted above, Part 1926, Subpart K (Electrical), belongs in 
this category. Other similar standards are Sec.  1926.351 (Arc Welding 
and Cutting), and Part 1926, Subpart V (Power Transmission and 
Distribution). OSHA is not modifying these standards for the same 
reasons listed above for general industry.
    Similar to the discussion regarding the Maritime standards, OSHA 
did not propose modifications of standards that do not contain 
definitions that are applicable to standards in the Subpart or 
explicitly reference standards that contain the definitions. The 
standards may contain phrases with the terms ``flammable liquid'' or 
``combustible liquid,'' but the definitions of the terms are absent. 
Standards belonging to this category of undefined terms include Sec.  
1926.66(c)(9)(i) (Criteria for design and construction of spray 
booths), Sec.  1926.252(e) (Disposal of waste materials), Sec.  
1926.307(p)(2)(ii) (Mechanical power-transmission apparatus), Sec.  
1926.352(c) and (h) (Fire prevention), Sec.  1926.803(l)(13) 
(Compressed air), and Sec.  1926.1101, Appendix B (Sampling and 
Analysis for Asbestos). In addition, some of these standards' 
requirements use the term ``flammable liquid'' without the term 
``combustible liquid,'' and some of the requirements use the term 
``combustible liquid'' without the term ``flammable liquid.'' As with 
the maritime standards, since OSHA has not changed the actual 
requirements of Sec.  1910.106 or Sec.  1926.155, OSHA does not 
anticipate that the final rule will affect the requirements of other 
OSHA standards that use some of the same terminology.
    In addition, OSHA did not modify standards that refer to flammable 
and combustible materials, storage piles, etc. that are not liquids. 
Examples are Sec.  1926.550(a)(15)(vii)(C) (Cranes and derricks), which 
refers to combustible and flammable materials; Sec.  1926.956(b)(3) 
(Underground lines), which refers to combustible gases; and Sec.  
1926.352(c) (Fire prevention), which refers to flammable compounds. In 
addition, Sec.  1926.154(e)(1) (Temporary heating devices) mentions 
``flammable liquids,'' but the term was not the focus of the standard. 
The requirement mentions flammable liquid-fired heaters, but the focus 
is on safety controls for the particular piece of equipment. Safety 
training and education, Sec.  1926.21(b)(5), is another example that 
contains some of the terminology, but its focus is on safety training. 
Flammable liquids are treated in a general sense, i.e., grouped with 
gases or toxic materials.
Miscellaneous
    A commenter from the International Chemical Workers Union Council 
recommended OSHA include a conversion formula for Centigrade and 
Fahrenheit or, at a minimum, provide the equivalent degrees when 
addressing flammable and combustible liquids, since in general 
employers and employees in the U.S. are more familiar with degrees 
Fahrenheit (Document ID  456). OSHA proposed to provide 
temperature equivalents, and in the final standard equivalents are 
included where there are requirements for flammable and combustible 
liquids. The formulas for conversion are:

(\9/5\) [deg]C + 32 = [deg]F or (\5/9\)([deg]F-32) = [deg]C

    Since the formulas for conversion are standard formulas found in 
textbooks, and since equivalents have been provided wherever possible 
for flammable and combustible liquids, OSHA has determined that it is 
not necessary to state the formulas for conversion in the actual 
regulations.

XIV. Authority and Signature

    This document was prepared under the direction of David Michaels, 
Assistant Secretary of Labor for Occupational Safety and Health, U.S.

[[Page 17764]]

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. 1-
2012 (77 FR 3912); and 29 CFR Part 1911.

List of Subjects

29 CFR Part 1910

    Asbestos, Blood, Chemicals, Diving, Fire prevention, Gases, Hazard 
communication, Hazardous substances, Health records, Incorporation by 
reference, 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.

    Signed at Washington, DC, on February 23, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.

Final Amendments

    For the reasons discussed in the preamble, the Occupational Safety 
and Health Administration amends 29 CFR parts 1910, 1915 and 1926 as 
set forth below:

PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS

Subpart A--[Amended]

0
1. Revise the authority citation for subpart A of part 1910 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), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355) or 
1-2012 (77 FR 3912), 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); Pub. L. 111-8 and 111-
317 and OMB Circular A-25 (dated July 8, 1993) (58 FR 38142, July 
15, 1993).


0
2. Amend Sec.  1910.6 by revising paragraphs (a)(4) and (h), the 
introductory text of paragraph (q), and by adding new paragraphs 
(q)(37), (y), and (z) to read as follows:


Sec.  1910.6  Incorporation by reference

    (a) * * *
    (4) Copies of standards listed in this section and issued by 
private standards organizations are available for purchase from the 
issuing organizations at the addresses or through the other contact 
information listed below for these private standards organizations. In 
addition, these standards are available for inspection at any Regional 
Office of the Occupational Safety and Health Administration (OSHA), or 
at the OSHA Docket Office, U.S. Department of Labor, 200 Constitution 
Avenue NW., Room N-2625, Washington, DC 20210; telephone: 202-693-2350 
(TTY number: 877-889-5627). They are also available for inspection at 
the National Archives and Records Administration (NARA). For 
information on the availability of these standards at NARA, telephone: 
202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
* * * * *
    (h) Copies of the standards listed below in this paragraph (h) are 
available for purchase from ASTM International, 100 Barr Harbor Drive, 
P.O. Box C700, West Conshohocken, PA 19428-2959; Telephone: 610-832-
9585; Fax: 610-832-9555; Email: seviceastm.org; Web site: http://www.astm.org. Copies of historical standards or standards that ASTM 
does not have may be purchased from Information Handling Services, 
Global Engineering Documents, 15 Inverness Way East, Englewood, CO 
80112; Telephone: 1-800-854-7179; Email: [email protected]; Web sites: 
http://global.ihs.com or http://www.store.ihs.com.
    (1) ASTM A 47-68, Malleable Iron Castings, IBR approved for Sec.  
1910.111.
    (2) ASTM A 53-69, Welded and Seamless Steel Pipe, IBR approved for 
Sec. Sec.  1910.110 and 1910.111.
    (3) ASTM A 126-66, Gray Iron Casting for Valves, Flanges and Pipe 
Fitting, IBR approved for Sec.  1910.111.
    (4) ASTM A 391-65 (ANSI G61.1-1968), Alloy Steel Chain, IBR 
approved for Sec.  1910.184.
    (5) ASTM A 395-68, Ductile Iron for Use at Elevated Temperatures, 
IBR approved for Sec.  1910.111.
    (6) ASTM B 88-66A, Seamless Copper Water Tube, IBR approved for 
Sec.  1910.252.
    (7) ASTM B 88-69, Seamless Copper Water Tube, IBR approved for 
Sec.  1910.110.
    (8) ASTM B 117-64, Salt Spray (Fog) Test, IBR approved for Sec.  
1910.268.
    (9) ASTM B 210-68, Aluminum-Alloy Drawn Seamless Tubes, IBR 
approved for Sec.  1910.110.
    (10) ASTM B 241-69, Standard Specifications for Aluminum-Alloy 
Seamless Pipe and Seamless Extruded Tube, IBR approved for Sec.  
1910.110.
    (11) ASTM D 5-65, Test for Penetration by Bituminous Materials, IBR 
approved for Sec.  1910.106.
    (12) ASTM D 56-70, Test for Flash Point by Tag Closed Tester, IBR 
approved for Sec.  1910.106.
    (13) ASTM D 56-05, Standard Test Method for Flash Point by Tag 
Closed Cup Tester, Approved May 1, 2005, IBR approved for Appendix B to 
Sec.  1910.1200.
    (14) ASTM D 86-62, Test for Distillation of Petroleum Products, IBR 
approved for Sec. Sec.  1910.106 and 1910.119.
    (15) ASTM D 86-07a, Standard Test Method for Distillation of 
Petroleum Products at Atmospheric Pressure, Approved April 1, 2007, IBR 
approved for Appendix B to Sec.  1910.1200.
    (16) ASTM D 88-56, Test for Saybolt Viscosity, IBR approved for 
Sec.  1910.106.
    (17) ASTM D 93-71, Test for Flash Point by Pensky Martens, IBR 
approved for Sec.  1910.106.
    (18) ASTM D 93-08, Standard Test Methods for Flash Point by Pensky-
Martens Closed Cup Tester, Approved Oct. 15, 2008, IBR approved for 
Appendix B to Sec.  1910.1200.
    (19) ASTM D 240-02 (Reapproved 2007), Standard Test Method for Heat 
of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter, Approved 
May 1, 2007, IBR approved for Appendix B to Sec.  1910.1200.

[[Page 17765]]

    (20) ASTM D 323-68, Standard Test Method of Test for Vapor Pressure 
of Petroleum Products (Reid Method), IBR approved for Sec.  1910.106.
    (21) ASTM D 445-65, Test for Viscosity of Transparent and Opaque 
Liquids, IBR approved for Sec.  1910.106.
    (22) ASTM D 1078-05, Standard Test Method for Distillation Range of 
Volatile Organic Liquids, Approved May 15, 2005, IBR approved for 
Appendix B to Sec.  1910.1200.
    (23) ASTM D 1692-68, Test for Flammability of Plastic Sheeting and 
Cellular Plastics, IBR approved for Sec.  1910.103.
    (24) ASTM D 2161-66, Conversion Tables for SUS, IBR approved for 
Sec.  1910.106.
    (25) ASTM D 3278-96 (Reapproved 2004) E1, Standard Test Methods for 
Flash Point of Liquids by Small Scale Closed-Cup Apparatus, Approved 
November 1, 2004, IBR approved for Appendix B to Sec.  1910.1200.
    (26) ASTM D 3828-07a, Standard Test Methods for Flash Point by 
Small Scale Closed Cup Tester, Approved July 15, 2007, IBR approved for 
Appendix B to Sec.  1910.1200.
    (27) ASTM F-2412-2005, Standard Test Methods for Foot Protection, 
IBR approved for Sec.  1910.136.
    (28) ASTM F-2413-2005, Standard Specification for Performance 
Requirements for Protective Footwear, IBR approved for Sec.  1910.136.
* * * * *
    (q) The following material is available for purchase from the 
National Fire Protection Association (NFPA), 1 Batterymarch Park, 
Quincy, MA 02269; Telephone: 800-344-3555 or 617-770-3000; Fax: 1-800-
593-6372 or 1-508-895-8301; Email: [email protected]; Web site: http://www.nfpa.org.
* * * * *
    (37) NFPA 30B, Code for the Manufacture and Storage of Aerosol 
Products, 2007 Edition, Approved August 17, 2006, IBR approved for 
Appendix B to Sec.  1910.1200.
* * * * *
    (y)(1) The following materials are available for purchase from the 
International Standards Organization (ISO) through ANSI, 25 West 43rd 
Street, Fourth Floor, New York, NY 10036-7417; Telephone: 212-642-4980; 
Fax: 212-302-1286; Email: [email protected]; Web site: http://www.ansi.org.
    (2) Documents not available in the ANSI store may be purchased 
from:
    (i) Document Center Inc., 111 Industrial Road, Suite 9, Belmont, 
94002; Telephone: 650-591-7600; Fax: 650-591-7617; Email: 
center.com">info@document-center.com; Web site: www.document-center.com.
    (ii) DECO--Document Engineering Co., Inc., 15210 Stagg Street, Van 
Nuys, CA 91405; Telephone: 800-645-7732 or 818-782-1010; Fax: 818-782-
2374; Email: [email protected]; Web site: www.doceng.com
    (iii) Global Engineering Documents, 15 Inverness Way East, 
Englewood, CO 80112; Telephone: 1-800-854-7179 or 303-397-7956; Fax: 
303-397-2740; Email: [email protected]; Web sites: http://global.ihs.com 
or http://www.store.ihs.com;
    (iv) ILI Infodisk, Inc., 610 Winters Avenue, Paramus, NJ 07652; 
Telephone: 201-986-1131; Fax: 201-986-7886; Email: info.com">sales@ili-info.com; 
Web site: www.ili-info.com.
    (v) Techstreet, a business of Thomson Reuters, 3916 Ranchero Drive, 
Ann Arbor, MI 48108; Telephone: 800-699-9277 or 734-780-8000; Fax: 734-
780-2046; Email: [email protected]; Web site: 
www.Techstreet.com.
    (3) ISO 10156:1996 (E), Gases and Gas Mixtures--Determination of 
Fire Potential and Oxidizing Ability for the Selection of Cylinder 
Valve Outlets, Second Edition, Feb. 15, 1996, IBR approved for Appendix 
B to Sec.  1910.1200.
    (4) ISO 10156-2:2005 (E), Gas cylinders--Gases and Gas Mixtures--
Part 2: Determination of Oxidizing Ability of Toxic and Corrosive Gases 
and Gas Mixtures, First Edition, Aug. 1, 2005, IBR approved for 
Appendix B to Sec.  1910.1200.
    (5) ISO 13943:2000 (E/F), Fire Safety--Vocabulary, First Edition, 
April, 15, 2000, IBR approved for Appendix B to Sec.  1910.1200.
    (z)(1) The following document is available for purchase from United 
Nations Publications, Customer Service, c/o National Book Network, 
15200 NBN Way, PO Box 190, Blue Ridge Summit, PA 17214; telephone: 1-
888-254-4286; fax: 1-800-338-4550; email: [email protected]. 
Other distributors of United Nations Publications include:
    (i) Bernan, 15200 NBN Way, Blue Ridge Summit, PA 17214; telephone: 
1-800-865-3457; fax: 1-800-865-3450; email: customercare@bernan; Web 
site: http://www.bernan.com; and
    (ii) Renouf Publishing Co. Ltd., 812 Proctor Avenue, Ogdensburg, NY 
13669-2205; telephone: 1-888-551-7470; Fax: 1-888-551-7471; email: 
[email protected]; Web site: http://www.renoufbooks.com.
    (2) UN ST/SG/AC.10/Rev.4, The UN Recommendations on the Transport 
of Dangerous Goods, Manual of Tests and Criteria, Fourth Revised 
Edition, 2003, IBR approved for Appendix B to Sec.  1910.1200.

Subpart H--[Amended]


0
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), 4-2010 (75 FR 55355) or 1-2012 (77 FR 
3912), 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.A. 655 
Note.
    Section 1910.120 also issued under Section 126, Superfund 
Amendments and Reauthorization Act of 1986 as amended (29 U.S.C.A. 
655 Note), and 5 U.S.C. 553.


0
4. Amend Sec.  1910.106 as follows:
0
A. Revise the section heading;
0
B. Revise paragraphs (a)(13), (a)(14)(i) through (a)(14)(iii), and 
(a)(19);
0
C. Remove the last sentence of paragraph (a)(17);
0
D. Remove and reserve paragraph (a)(18);
0
E. Remove the words ``or combustible'' wherever they appear in Sec.  
1910.106.
0
F. Remove the words ``and combustible'' in paragraphs (d)(5)(vi) 
introductory text, (e)(2) introductory text, (j)(1) and (j)(3);
0
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), 
and (b)(4)(iv)(e);
0
H. Revise paragraphs (d)(1)(ii)(b), (d)(2)(iii) introductory text and 
(d)(2)(iii)(a)(2), Table H-12, paragraphs (d)(3)(i), (d)(4)(iii), 
(d)(4)(iv), Tables H-14 through H-17, and paragraph (d)(7)(i)(b);
0
I. Revise paragraphs (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), and (e)(7)(i)(c);
0
J. Revise paragraphs (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), and (f)(8);
0
K. Revise paragraphs (g)(1)(i)(c), (g)(1)(i)(e) introductory text, 
(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),

[[Page 17766]]

(g)(3)(iv)(c), (g)(3)(v)(a), (g)(3)(vi)(a), Table H-19, and paragraphs 
(g)(4)(iii)(d), (g)(5)(i), (g)(6)(iv), and (g)(7); and
0
L. Revise paragraphs (h)(3)(i)(a), (h)(3)(iii)(b), (h)(3)(iv), (h)(5), 
(h)(7)(i)(b), (h)(7)(iii)(c), and (j).
    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 
[deg]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, or an equivalent test method as defined in Appendix B 
to Sec.  1910.1200--Physical Hazard Criteria, shall be used.
    (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) or an 
equivalent method as defined by Appendix B to Sec.  1910.1200--Physical 
Hazard Criteria, shall be used 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 standard is 
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 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)(1) 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.
    (2) Exemption: Tanks of 3,000 bbls (barrels). 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 (b)(2)(vi)(b) of this section.)
    (g) Flame arresters or venting devices required in paragraph 
(b)(2)(iv)(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

[[Page 17767]]

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
* * * * *

            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).

    (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.
* * * * *
BILLING CODE 4510-26-P

[[Page 17768]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.054


[[Page 17769]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.055


[[Page 17770]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.056


[[Page 17771]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.057

BILLING CODE 4510-26-C

    (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

[[Page 17772]]

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 only Category 3 flammable 
liquids with a flashpoint at or above 100 [deg]F (37.8 [deg]C) or 
Category 4 flammable liquids 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 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

[[Page 17773]]

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 only 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) 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 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

[[Page 17774]]

liquids, or Category 3 flammable liquids with a flashpoint below 100 
[deg]F (37.8 [deg]C).
* * * * *
    (4) * * *
    (iii) * * *
BILLING CODE 4510-26-P
[GRAPHIC] [TIFF OMITTED] TR26MR12.058


[[Page 17775]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.059

BILLING CODE 4510-26-C
    (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 Category 1 or 2 flammable liquids or 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

[[Page 17776]]

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 [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 at or below 199.4 [deg]F (93 
[deg]C) unless otherwise noted. This section does not apply to:
* * * * *

0
5. Amend Sec.  1910.107 as follows:
0
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'' wherever it appears and adding in its place the phrase 
``flammable liquids or liquids with a flashpoint greater than 199.4 
[deg]F (93 [deg]C)''; and
0
B. Revise the heading of paragraph (e), 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.
* * * * *

0
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) * * *
    Trade secret means any confidential formula, pattern, process, 
device, information or compilation of information that is used in an 
employer's business, and that gives the employer an opportunity to 
obtain an advantage over competitors who do not know or use it. See 
Appendix E to Sec.  1910.1200--Definition of a Trade Secret (which sets 
out the criteria to be used in evaluating trade secrets).
* * * * *

0
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

[[Page 17777]]

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 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); aspiration 
toxicity or simple asphyxiant. (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.)
* * * * *

0
8. Amend paragraph (d) of Sec.  1910.123 by removing the definition of 
``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 any liquid having a flashpoint at or below 
199.4[emsp14][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.
* * * * *

0
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 
flashpoints greater than 199.4 [deg]F (93 [deg]C) is:
* * * * *

0
10. Amend Sec.  1910.125 by revising the section heading and the 
introductory text (including the table) to read as follows:


Sec.  1910.125  Additional requirements for dipping and coating 
operations that use flammable liquids or liquids with flashpoints 
greater than 199.4 [deg]F (93 [deg]C).

    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 also comply with this section
                  if:                                  And:
------------------------------------------------------------------------
 The flashpoint of the liquid     The liquid is heated
 is 199.4 [deg]F (93 [deg]C) or above.    as part of the operation; or
                                          A heated object is
                                          placed in the liquid.
------------------------------------------------------------------------


0
11. Amend the introductory text of paragraph (c) of Sec.  1910.126 by 
removing the words ``or combustible''.

Subpart Q--[Amended]

0
12. The authority citation for subpart Q continues 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), 5-2007 (72 FR 31159), 4-2010 (75 FR 
55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.


0
13. Amend Sec.  1910.252 as follows;
0
A. Revise paragraph (c)(1)(iv);
0
B. Add new paragraphs (c)(1)(v) and (c)(1)(vi).


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) (Sec.  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 Sec.  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 and shall label 
in accordance with Sec.  1910.1200 any hazards associated with the use 
of their materials in welding, cutting, and brazing.
    (B) In addition to any requirements imposed by Sec.  1910.1200, 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 contain fluorine 
compounds, the labels shall indicate the hazards associated with 
fluorine compounds including eye and respiratory tract effects.
    (vi) Prior to June 1, 2015, employers may include the following 
information on labels in lieu of the labeling requirements in paragraph 
(c)(1)(v) of this section:
    (A) All filler metals and fusible granular materials shall carry 
the following notice, as a minimum, on tags, boxes, or other 
containers:

CAUTION

    Welding may produce fumes and gases hazardous to health. Avoid 
breathing these fumes and gases. Use adequate ventilation. See ANSI 
Z49.1-1967 Safety in Welding and Cutting published by the American 
Welding Society.
    (B) Brazing (welding) filler metals containing cadmium in 
significant amounts shall carry the following notice on tags, boxes, or 
other containers:

WARNING
CONTAINS CADMIUM--POISONOUS FUMES MAY BE FORMED ON HEATING

    Do not breathe fumes. Use only with adequate ventilation such as 
fume collectors, exhaust ventilators, or air-supplied respirators. See 
ANSI Z49.1-1967. If chest pain, cough, or fever develops after use call 
physician immediately.
    (C) Brazing and gas welding fluxes containing fluorine compounds 
shall have a cautionary wording to indicate that they contain fluorine 
compounds. One such cautionary wording recommended by the American 
Welding

[[Page 17778]]

Society for brazing and gas welding fluxes reads as follows:

CAUTION
CONTAINS FLUORIDES

    This flux when heated gives off fumes that may irritate eyes, nose 
and throat.
    1. Avoid fumes--use only in well-ventilated spaces.
    2. Avoid contact of flux with eyes or skin.
    3. Do not take internally.
* * * * *

Subpart Z--[Amended]

0
14. Revise the authority citation for subpart Z to read as follows:

    Authority:  Sections 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), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 
1-2012 (77 FR 3912), 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, 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.
    Section 1910.1201 also issued under 49 U.S.C. 1801-1819 and 5 
U.S.C. 533.

0
15. Amend Sec.  1910.1001 as follows:
0
A. Remove paragraph (j)(5);
0
B. Redesignate paragraphs (j)(1) through (j)(4) as paragraphs (j)(2) 
through (j)(5);
0
C. Revise paragraphs (h)(2)(iv), (h)(3)(vi), the newly redesignated 
paragraphs (j)(4), (j)(5), and the introductory text of paragraph 
(j)(6);
0
D. Add new paragraph (j)(1);
0
E. Amend Appendix F, to Sec.  1910.1001, Paragraph [A] (6) by removing 
``(j)(4)'' and adding in its place ``(j)(5)''.
    The revisions and additions 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. (i) Chemical manufacturers, 
importers, distributors and employers shall comply with all 
requirements of the Hazard Communication Standard (HCS) (Sec.  
1910.1200) for asbestos.
    (ii) In classifying the hazards of asbestos at least the following 
hazards are to be addressed: Cancer and lung effects.
    (iii) Employers shall include asbestos in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 requirements of HCS and paragraph (j)(7) of this section.
* * * * *
    (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

    (C) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (j)(4)(ii)(A) of this section:

DANGER
ASBESTOS
CANCER AND LUNG DISEASE
HAZARD
AUTHORIZED PERSONNEL ONLY

    (D) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (j)(4)(ii)(B) of this section:

RESPIRATORS AND PROTECTIVE CLOTHING ARE REQUIRED 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 the 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
AVOID CREATING DUST


[[Page 17779]]


    (iii) Prior to June 1, 2015, employers may include the following 
information on raw materials, mixtures or labels of bags or containers 
of protective clothing and equipment, scrap, waste, and debris 
containing asbestos fibers in lieu of the labeling requirements in 
paragraphs (j)(1)(i) and (j)(5)(ii) of this section:

DANGER
CONTAINS ASBESTOS FIBERS
AVOID CREATING DUST
CANCER AND LUNG DISEASE HAZARD

    (6) The provisions for labels and for safety data sheets required 
by paragraph (j) of this section do not apply where:
* * * * *

0
16. Amend Sec.  1910.1003 as follows:
0
A. In the last sentence in paragraph (c)(4)(v) remove the words 
``paragraphs (e)(2), (3), and (4)'' and add the words ``paragraph (e)'' 
in their place;
0
B. Revise the heading of paragraph (e);
0
C. Revise paragraphs (e)(1) and (e)(2).
0
D. Remove paragraph (e)(3); and
0
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. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for each carcinogen listed in paragraph (e)(1)(iv) of 
this section.
    (ii) In classifying the hazards of carcinogens listed in paragraph 
(e)(1)(iv) of this section, at least the hazards listed in paragraph 
(e)(1)(iv) are to be addressed.
    (iii) Employers shall include the carcinogens listed in paragraph 
(e)(1)(iv) of this section in the hazard communication program 
established to comply with the HCS (Sec.  1910.1200). Employers shall 
ensure that each employee has access to labels on containers of the 
carcinogens listed in paragraph (e)(1)(iv) and to safety data sheets, 
and is trained in accordance with the requirements of HCS and paragraph 
(e)(4) of this section.
    (iv) List of Carcinogens:
    (A) 4-Nitrobiphenyl: Cancer.
    (B) alpha-Naphthylamine: Cancer; skin irritation; and acute 
toxicity effects.
    (C) Methyl chloromethyl ether: Cancer; skin, eye and respiratory 
effects; acute toxicity effects; and flammability.
    (D) 3,3'-Dichlorobenzidine (and its salts): Cancer and skin 
sensitization.
    (E) bis-Chloromethyl ether: Cancer; skin, eye, and respiratory 
tract effects; acute toxicity effects; and flammability.
    (F) beta-Naphthylamine: Cancer and acute toxicity effects.
    (G) Benzidine: Cancer and acute toxicity effects.
    (H) 4-Aminodiphenyl: Cancer.
    (I) Ethyleneimine: Cancer; mutagenicity; skin and eye effects; 
liver effects; kidney effects; acute toxicity effects; and 
flammability.
    (J) beta-Propiolactone: Cancer; skin irritation; eye effects; and 
acute toxicity effects.
    (K) 2-Acetylaminofluorene: Cancer.
    (L) 4-Dimethylaminoazo-benzene: Cancer; skin effects; and 
respiratory tract irritation.
    (M) N-Nitrosodimethylamine: Cancer; liver effects; and acute 
toxicity effects.
    (2) Signs. (i) The employer shall post entrances to regulated areas 
with signs bearing the legend:

DANGER
(CHEMICAL IDENTIFICATION)
MAY CAUSE CANCER
AUTHORIZED PERSONNEL ONLY

    (ii) The employer shall post signs at entrances to regulated areas 
containing operations covered in paragraph (c)(5) of this section. The 
signs shall bear the legend:

DANGER
(CHEMICAL IDENTIFICATION)
MAY CAUSE CANCER
WEAR AIR-SUPPLIED HOODS, IMPERVIOUS SUITS, AND PROTECTIVE EQUIPMENT 
IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (iii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (e)(2)(i) of this section:

CANCER-SUSPECT AGENT
AUTHORIZED PERSONNEL ONLY

    (iv) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (e)(2)(ii) of this section:

CANCER-SUSPECT AGENT EXPOSED IN THIS AREA
IMPERVIOUS SUIT INCLUDING GLOVES, BOOTS, AND AIR-SUPPLIED HOOD 
REQUIRED AT ALL TIMES
AUTHORIZED PERSONNEL ONLY

    (v) 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.
* * * * *

0
17. Revise Sec.  1910.1017 paragraph (l) to read as follows:


Sec.  1910.1017  Vinyl chloride.

* * * * *
    (l) Communication of hazards--(1) Hazard communication--general. 
(i) Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for vinyl chloride and polyvinyl chloride.
    (ii) In classifying the hazards of vinyl chloride at least the 
following hazards are to be addressed: Cancer; central nervous system 
effects; liver effects; blood effects; and flammability.
    (iii) Employers shall include vinyl chloride in the hazard 
communication program established to comply with the HCS (Sec.  
1910.1200). Employers 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 requirements of HCS and paragraph (j) 
of this section.
    (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

    (iii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (l)(2)(i) of this section:

CANCER-SUSPECT AGENT AREA
AUTHORIZED PERSONNEL ONLY

    (iv) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (l)(2)(ii) of this section:

CANCER-SUSPECT AGENT IN THIS AREA
PROTECTIVE EQUIPMENT REQUIRED
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

    (ii) Prior to June 1, 2015, employers may include the following 
information on labels of containers of polyvinyl chloride resin waste 
from reactors or other waste contaminated with vinyl

[[Page 17780]]

chloride in lieu of the labeling requirements in paragraphs (l)(3)(i) 
of this section:

CONTAMINATED WITH VINYL CHLORIDE
CANCER-SUSPECT AGENT

    (4) Prior to June 1, 2015, employers may include the following 
information for containers of polyvinyl chloride in lieu of the 
labeling requirements in paragraphs (l)(1)(i) of this section:

POLYVINYL CHLORIDE (OR TRADE NAME)
Contains
VINYL CHLORIDE
VINYL CHLORIDE IS A CANCER-SUSPECT AGENT

    (5)(i) Prior to June 1, 2015, employers may include either the 
following information in either paragraph (l)(5)(i) or (l)(5)(ii) of 
this section on containers of vinyl chloride in lieu of the labeling 
requirements in paragraph (l)(1)(i) of this section:

VINYL CHLORIDE
EXTREMELY FLAMMABLE GAS UNDER PRESSURE
CANCER-SUSPECT AGENT

    (ii) In accordance with 49 CFR Parts 170-189, with the additional 
legend applied near the label or placard:

CANCER-SUSPECT AGENT

    (6) 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.
* * * * *

0
18. Revise Sec.  1910.1018 paragraphs (j)(2)(vii) and (p) to read as 
follows:


Sec.  1910.1018  Inorganic arsenic.

* * * * *
    (j) * * *
    (2) * * *
    (vii) Labels on contaminated protective clothing and equipment.
    (A) 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 REMOVE DUST BY BLOWING OR SHAKING. DISPOSE OF INORGANIC ARSENIC 
CONTAMINATED WASH WATER IN ACCORDANCE WITH APPLICABLE LOCAL, STATE 
OR FEDERAL REGULATIONS.

    (B) Prior to June 1, 2015, employers may include the following 
information on containers of protective clothing and equipment in lieu 
of the labeling requirements in paragraphs (j)(2)(vii) of this section:


CAUTION: Clothing contaminated with inorganic arsenic; do not remove 
dust by blowing or shaking. Dispose of inorganic arsenic contaminated 
wash water in accordance with applicable local, State or Federal 
regulations.
* * * * *
    (p) Communication of hazards--(1) Hazard communication--General. 
(i) Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for inorganic arsenic.
    (ii) In classifying the hazards of inorganic arsenic at least the 
following hazards are to be addressed: Cancer; liver effects; skin 
effects; respiratory irritation; nervous system effects; and acute 
toxicity effects.
    (iii) Employers shall include inorganic arsenic in the hazard 
communication program established to comply with the HCS (Sec.  
1910.1200). Employers 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 requirements of HCS and paragraph 
(o) of this section.
    (iv) The employer shall ensure that no statement appears on or near 
any sign or label required by this paragraph (p) 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) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (p)(2)(i) of this section:

DANGER
INORGANIC ARSENIC
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
NO SMOKING OR EATING
RESPIRATOR REQUIRED

    (iii) The employer shall ensure that signs required by this 
paragraph (p) are illuminated and cleaned as necessary so that the 
legend is readily visible.
    (3)(i) Prior to June 1, 2015, in lieu of the labeling requirements 
in paragraphs (p)(1)(i) of this section, employers may apply 
precautionary labels to all shipping and storage containers of 
inorganic arsenic, and to all products containing inorganic arsenic, 
bearing the following legend:

DANGER
CONTAINS INORGANIC ARSENIC
CANCER HAZARD
HARMFUL IF INHALED OR SWALLOWED
USE ONLY WITH ADEQUATE VENTILATION OR RESPIRATORY PROTECTION

    (ii) Labels are not required when the inorganic arsenic in the 
product is bound in such a manner so as to make unlikely the 
possibility of airborne exposure to inorganic arsenic. (Possible 
examples of products not requiring labels are semiconductors, light 
emitting diodes and glass.)
* * * * *

0
19. Amend Sec.  1910.1025 as follows:
0
A. Revise paragraph (g)(2)(vii) and paragraph (m);
0
B. Revise Appendix B to Sec.  1910.1025, paragraph xi.
    The revisions read as follows:


Sec.  1910.1025  Lead.

* * * * *
    (g) * * *
    (2) * * *
    (vii) Labeling of contaminated protective clothing and equipment.
    (A) The employer shall ensure that labels of bags or containers of 
contaminated protective clothing and equipment include the following 
information:

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. DISPOSE OF LEAD CONTAMINATED WASH WATER IN 
ACCORDANCE WITH APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.

    (B) Prior to June 1, 2015, employers may include the following 
information on bags or containers of contaminated protective clothing 
and equipment in lieu of the labeling requirements in paragraphs 
(g)(2)(vii)(A) of this section:

CAUTION: CLOTHING CONTAMINATED WITH LEAD. DO NOT REMOVE DUST BY 
BLOWING OR SHAKING. DISPOSE OF LEAD CONTAMINATED WASH WATER IN 
ACCORDANCE WITH APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.
* * * * *
    (m) Communication of hazards--(1) Hazard communication--general. 
(i) Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for lead.
    (ii) In classifying the hazards of lead at least the following 
hazards are to be addressed: Reproductive/developmental

[[Page 17781]]

toxicity; central nervous system effects; kidney effects; blood 
effects; and acute toxicity effects.
    (iii) Employers shall include lead in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 
requirements of HCS and paragraph (l) of this section.
    (2) Signs. (i) The employer shall post the following warning signs 
in each work area where the PEL is exceeded:

DANGER
LEAD
MAY DAMAGE FERTILITY OR THE UNBORN CHILD
CAUSES DAMAGE TO THE CENTRAL NERVOUS SYSTEM
DO NOT EAT, DRINK OR SMOKE IN THIS AREA

    (ii) The employer shall ensure that no statement appears on or near 
any sign required by this paragraph (m)(2) which contradicts or 
detracts from the meaning of the required sign.
    (iii) The employer shall ensure that signs required by this 
paragraph (m)(2) 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 (m)(2).
    (v) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (m)(2)(ii) of this section:

WARNING
LEAD WORK AREA
POISON
NO SMOKING OR EATING
* * * * *

Appendix B to Sec.  1910.1025--Employee Standard Summary

* * * * *

xi. SIGNS--PARAGRAPH (m)

    The standard requires that the following warning sign be posted in 
the work areas when the exposure to lead exceeds 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

    However, prior to June 1, 2016, employers may use the following 
legend in lieu of that specified above:

WARNING
LEAD WORK AREA
POISON
NO SMOKING OR EATING
* * * * *


0
20. Revise Sec.  1910.1026, paragraphs (h)(2)(iv) 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, Sec.  1910.1200.
* * * * *
    (l) * * *
    (1) Hazard communication--general (i) Chemical manufacturers, 
importers, distributors and employers shall comply with all 
requirements of the Hazard Communication Standard (HCS) (Sec.  
1910.1200) for chromium (VI).
    (ii) In classifying the hazards of chromium (VI) at least the 
following hazards are to be addressed: Cancer, eye irritation, and skin 
sensitization.
    (iii) Employers shall include chromium (VI) in the hazard 
communication program established to comply with the HCS (Sec.  
1910.1200). Employers 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 requirements of HCS and paragraph (l)(2) 
of this section.
* * * * *

0
21. Revise Sec.  1910.1027 paragraphs (k)(7), (m)(1), (m)(2), and 
(m)(3) to read as follows:


Sec.  1910.1027  Cadmium.

* * * * *
    (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.--general. (i) Chemical manufacturers, 
importers, distributors and employers shall comply with all 
requirements of the Hazard Communication Standard (HCS) (Sec.  
1910.1200) for cadmium.
    (ii) In classifying the hazards of cadmium at least the following 
hazards are to be addressed: Cancer; lung effects; kidney effects; and 
acute toxicity effects.
    (iii) Employers shall include cadmium in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 requirements of HCS and paragraph (m)(4) of this section.
    (2) Warning signs. (i) Warning signs shall be provided and 
displayed in regulated areas. 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) 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

    (iii) The employer shall ensure that signs required by this 
paragraph (m)(2) are illuminated, cleaned, and maintained as necessary 
so that the legend is readily visible.
    (iv) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (m)(2)(ii) of this section:

DANGER
CADMIUM
CANCER HAZARD
CAN CAUSE LUNG AND KIDNEY DISEASE
AUTHORIZED PERSONNEL ONLY
RESPIRATORS REQUIRED IN THIS AREA

    (3) Warning labels. (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 containers of contaminated protective 
clothing, equipment, waste, scrap, or debris shall include at least the 
following information:

DANGER
CONTAINS CADMIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS AND KIDNEYS
AVOID CREATING DUST

    (iii) Prior to June 1, 2015, employers may include the following 
information on shipping and storage containers containing cadmium, 
cadmium compounds, or cadmium contaminated clothing, equipment, waste, 
scrap, or debris in lieu of the labeling

[[Page 17782]]

requirements specified in paragraphs (m)(1)(i) and (m)(3)(ii) of this 
section:

DANGER
CONTAINS CADMIUM
CANCER HAZARD
AVOID CREATING DUST
CAN CAUSE LUNG AND KIDNEY DISEASE

    (iv) Where feasible, installed cadmium products shall have a 
visible label or other indication that cadmium is present.
* * * * *
0
22. Revise Sec.  1910.1028, paragraph (j) heading, and paragraphs 
(j)(1) and (j)(2) to read as follows:


Sec.  1910.1028  Benzene.

* * * * *
    (j) Communication of hazards--(1) Hazard communication--general. 
(i) Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for benzene.
    (ii) In classifying the hazards of benzene at least the following 
hazards are to be addressed: Cancer; central nervous system effects; 
blood effects; aspiration; skin, eye, and respiratory tract irritation; 
and flammability.
    (iii) Employers shall include benzene in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 requirements of HCS and paragraph (j)(3) of this section.
    (2) Warning signs and labels. (i)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

    (ii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (j)(2)(i) of this section:

DANGER
BENZENE
CANCER HAZARD
FLAMMABLE--NO SMOKING
AUTHORIZED PERSONNEL ONLY
RESPIRATOR REQUIRED

    (iii) The employer shall ensure that labels or other appropriate 
forms of warning are provided for containers of benzene within the 
workplace. There is no requirement to label pipes. The labels shall 
comply with the requirements of paragraph (j)(1) of this section and 
Sec.  1910.1200(f).
    (iv) Prior to June 1, 2015, employers shall include the following 
legend or similar language on the labels or other appropriate forms of 
warning:

DANGER
CONTAINS BENZENE
CANCER HAZARD

* * * * *

0
23. Revise Sec.  1910.1029 paragraph (l) heading, and paragraphs (l)(1) 
through (l)(3) to read as follows:


Sec.  1910.1029  Coke oven emissions.

* * * * *
    (l) Communication of hazards--(1) Hazard communication--general. 
The employer shall include coke oven emissions in the program 
established to comply with the Hazard Communication Standard (HCS) 
(Sec.  1910.1200). The employer shall ensure that each employee has 
access to labels on containers of chemicals and substances associated 
with coke oven processes and to safety data sheets, and is trained in 
accordance with the provisions of HCS and paragraph (k) of this 
section. The employer shall ensure that at least the following hazard 
is addressed: Cancer.
    (2) Signs. (i) The employer shall post signs in the regulated area 
bearing the legend:

DANGER
COKE OVEN EMISSIONS
MAY CAUSE CANCER
DO NOT EAT, DRINK OR SMOKE
WEAR RESPIRATORY PROTECTION IN THIS AREA
AUTHORIZED PERSONNEL ONLY

    (ii) In addition, the employer shall post signs in the areas where 
the permissible exposure limit is exceeded bearing the legend:

WEAR RESPIRATORY PROTECTION IN THIS AREA

    (iii) The employer shall ensure that no statement appears on or 
near any sign required by this paragraph (l) which contradicts or 
detracts from the effects of the required sign.
    (iv) The employer shall ensure that signs required by this 
paragraph (l)(2) are illuminated and cleaned as necessary so that the 
legend is readily visible.
    (v) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (l)(2)(i) of this section:

DANGER
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
NO SMOKING OR EATING

    (vi) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (l)(2)(ii) of this section:

DANGER
RESPIRATOR REQUIRED

    (3) Labels. (i) 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 REMOVE DUST BY BLOWING OR SHAKING

    (ii) Prior to June 1, 2015, employers may include the following 
information on contaminated protective clothing and equipment in lieu 
of the labeling requirements in paragraph (l)(3)(i) of this section:

CAUTION
CLOTHING CONTAMINATED WITH COKE EMISSIONS
DO NOT REMOVE DUST BY BLOWING OR SHAKING

* * * * *

0
24. Revise Sec.  1910.1043 paragraph (j) to read as follows:


Sec.  1910.1043  Cotton dust.

* * * * *
    (j) Signs. (1) 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

    (2) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (j)(1) of this section:

WARNING
COTTON DUST WORK AREA
MAY CAUSE ACUTE OR DELAYED
LUNG INJURY
(BYSSINOSIS)
RESPIRATORS
REQUIRED IN THIS AREA
* * * * *

0
25. Revise Sec.  1910.1044 paragraphs (j)(2)(v), (k)(1)(iii)(b), and 
paragraph (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

[[Page 17783]]

labels with 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 
(j)(2)(v) of this section.
* * * * *
    (o) Communication of hazards--(1) Hazard communication--general. 
(i) Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for DBCP.
    (ii) In classifying the hazards of DBCP at least the following 
hazards are to be addressed: Cancer; reproductive effects; liver 
effects; kidney effects; central nervous system effects; skin, eye and 
respiratory tract irritation; and acute toxicity effects.
    (iii) Employers shall include DBCP in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 
requirements of HCS and paragraph (n) of this section.
    (iv) The employer shall ensure that no statement appears on or near 
any sign or label required by this paragraph (o) which contradicts or 
detracts from the meaning of the required sign or label.
    (2) Signs. (i) 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

    (ii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (o)(2) of this section:

DANGER
1,2-Dibromo-3-chloropropane
(Insert appropriate trade or common names)
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATOR REQUIRED

    (3) Labels. (i) Where DBCP or products containing DBCP are sold, 
distributed or otherwise leave the employer's workplace bearing 
appropriate labels required by EPA under the regulations in 40 CFR Part 
162, the labels required by this paragraph (o)(3) need not be affixed.
    (ii) The employer shall ensure that the precautionary labels 
required by this paragraph (o)(3) are readily visible and legible.
    (iii) Prior to June 1, 2015, employers may include the following 
information on containers of DBCP or products containing DBCP, DBCP-
contaminated protective devices or work clothing or DBCP-contaminated 
portable vacuums in lieu of the labeling requirements in paragraphs 
(j)(2)(v), (k)(l)(iii)(b) and (o)(1)(i) of this section:

DANGER
1,2-Dibromo-3-chloropropane
CANCER HAZARD

* * * * *
0
26. Revise Sec.  1910.1045 paragraph (p) to read as follows:


Sec.  1910.1045  Acrylonitrile.

* * * * *
    (p) Communication of hazards--(1) Hazard communication--general. 
(i) Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for AN and AN-based materials not exempted under 
paragraph (a)(2) of this section.
    (ii) In classifying the hazards of AN and AN-based materials at 
least the following hazards are to be addressed: Cancer; central 
nervous system effects; liver effects; skin sensitization; skin, 
respiratory, and eye irritation; acute toxicity effects; and 
flammability.
    (iii) Employers shall include AN and AN-based materials in the 
hazard communication program established to comply with the HCS (Sec.  
1910.1200). Employers shall ensure that each employee has access to 
labels on containers of AN and AN-based materials and to safety data 
sheets, and is trained in accordance with the requirements of HCS and 
paragraph (o) of this section.
    (iv) The employer shall ensure that no statement appears on or near 
any sign or label required by this paragraph (p) that contradicts or 
detracts from the required sign or label.
    (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

    (ii) The employer shall ensure that signs required by this 
paragraph (p)(2) are illuminated and cleaned as necessary so that the 
legend is readily visible.
    (iii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (p)(2)(i) of this section:

DANGER
ACRYLONITRILE (AN)
CANCER HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS MAY BE REQUIRED

    (3) Labels. (i) The employer shall ensure that precautionary labels 
are in compliance with paragraph (p)(1)(i) of this section and 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.
    (ii) Prior to June 1, 2015, employers may include the following 
information on precautionary labels required by this paragraph (p)(3) 
in lieu of the labeling requirements in paragraph (p)(1) of this 
section:

DANGER
CONTAINS ACRYLONITRILE (AN)
CANCER HAZARD

    (iii) The employer shall ensure that the precautionary labels 
required by this paragraph (p)(3) are readily visible and legible.
* * * * *

0
27. Revise Sec.  1910.1047 paragraph (j) heading, and paragraphs (j)(1) 
and (j)(2) to read as follows:


Sec.  1910.1047  Ethylene oxide.

* * * * *
    (j) Communication of hazards--(1) Hazard communication--general. 
(i) Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for EtO.
    (ii) In classifying the hazards of EtO at least the following 
hazards are to be addressed: Cancer; reproductive effects; 
mutagenicity; central nervous system; skin sensitization; skin, eye and 
respiratory tract irritation; acute toxicity effects; and flammability.
    (iii) Employers shall include EtO in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 
requirements of HCS and paragraph (j)(3) of this section.

[[Page 17784]]

    (2) Signs and labels--(i) Signs. (A) 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

    (B) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (j)(2)(i)(A) of this section:

DANGER
ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE HAZARD
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN 
THIS AREA

    (ii) Labels. (A) 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 (j)(2)(ii), reaction 
vessels, storage tanks, and pipes or piping systems are not considered 
to be containers.
    (B) Prior to June 1, 2015, employers may include the following 
information on containers of EtO in lieu of the labeling requirements 
in paragraph (j)(1)(i) of this section:

(1) DANGER
CONTAINS ETHYLENE OXIDE
CANCER HAZARD AND REPRODUCTIVE HAZARD;
(2) A warning statement against breathing airborne concentrations of 
EtO.

    (C) 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.
* * * * *

0
28. Revise Sec.  1910.1048 paragraphs (e)(1), (h)(2)(ii), (j)(4) and 
(m) to read as follows:


Sec.  1910.1048  Formaldehyde.

* * * * *
    (e) * * *
    (1) Signs. (i) 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

    (ii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (e)(1)(i) of this section:

DANGER
FORMALDEHYDE
IRRITANT AND POTENTIAL CANCER HAZARD
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 are labeled consistent with the Hazard 
Communication Standard, Sec.  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

    (C) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (h)(2)(ii)(A) of this section:

DANGER
FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT
AVOID INHALATION AND SKIN CONTACT

    (D) Prior to June 1, 2015, employers may include the following 
information on containers of protective clothing and equipment in lieu 
of the labeling requirements in paragraphs (h)(2)(ii)(B) of this 
section:

DANGER
FORMALDEHYDE-CONTAMINATED [CLOTHING] EQUIPMENT
AVOID INHALATION AND SKIN CONTACT

* * * * *
    (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--General. 
(i) Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for formaldehyde.
    (ii) In classifying the hazards of formaldehyde at least the 
following hazards are to be addressed: Cancer; skin and respiratory 
sensitization; eye, skin and respiratory tract irritation; acute 
toxicity effects; and flammability.
    (iii) Employers shall include formaldehyde in the hazard 
communication program established to comply with the HCS (Sec.  
1910.1200). Employers 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 requirements of HCS and paragraph (n) of 
this section.
    (iv) Paragraphs (m)(1)(i), (m)(1)(ii), and (m)(1)(iii) of this 
section apply to chemicals 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.
    (v) 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)(i) In addition to the requirements in paragraphs (m)(1) through 
(m)(1)(iv) of this section, for materials listed in paragraph 
(m)(1)(iv) 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

[[Page 17785]]

contain the hazard statement ``May Cause Cancer.''
    (ii) As a minimum, for all materials listed in paragraph (m)(1)(i) 
and (iv) of this section capable of releasing formaldehyde at levels of 
0.1 ppm to 0.5 ppm, labels shall identify that the product contains 
formaldehyde; list the name and address of the responsible party; and 
state that physical and health hazard information is readily available 
from the employer and from safety data sheets.
    (iii) Prior to June 1, 2015, employers may include the phrase 
``Potential Cancer Hazard'' in lieu of ``May Cause Cancer'' as 
specified in paragraph (m)(2)(i) of this section.
* * * * *

0
29. Amend Sec.  1910.1050 as follows:
0
A. Revise the heading of paragraph (k);
0
B. Revise paragraphs (k)(1) and (k)(2);
0
C. Redesignate paragraphs (k)(3) and (k)(4) as (k)(4) and (k)(5);
0
D. Add new paragraph (k)(3).
    The revisions and additions read as follows:


Sec.  1910.1050  Methylenedianiline.

* * * * *
    (k) Communication of hazards--(1) Hazard communication--general.
    (i) Chemical manufacturers, importers, distributors and employers 
shall comply with all requirements of the Hazard Communication Standard 
(HCS) (Sec.  1910.1200) for MDA.
    (ii) In classifying the hazards of MDA at least the following 
hazards are to be addressed: Cancer; liver effects; and skin 
sensitization.
    (iii) Employers shall include MDA in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 
requirements of HCS and paragraph (k)(4) of this section.
    (2) Signs and labels--(i) Signs. (A) 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

    (B) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (k)(2)(i)(A) of this section:

DANGER
MDA
MAY CAUSE CANCER
LIVER TOXIN
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN 
THIS AREA

    (ii) Labels. Prior to June 1, 2015, employers may include the 
following information workplace labels in lieu of the labeling 
requirements in paragraph (k)(1) of this section:

    (A) For pure MDA:

DANGER
CONTAINS MDA
MAY CAUSE CANCER
LIVER TOXIN

    (B) For mixtures containing MDA:

DANGER
CONTAINS MDA
CONTAINS MATERIALS WHICH MAY CAUSE CANCER
LIVER TOXIN

    (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.
* * * * *

0
30. Revise Sec.  1910.1051 paragraph (l)(1) to read as follows:


Sec.  1910.1051  1,3-Butadiene.

* * * * *
    (l) * * *
    (1) Hazard communication--general. (i) Chemical manufacturers, 
importers, distributors and employers shall comply with all 
requirements of the Hazard Communication Standard (HCS) (Sec.  
1910.1200) for BD.
    (ii) In classifying the hazards of BD at least the following 
hazards are to be addressed: Cancer; eye and respiratory tract 
irritation; center nervous system effects; and flammability.
    (iii) Employers shall include BD in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 
requirements of HCS and paragraph (l)(2) of this section.
* * * * *
0
31. Amend Sec.  1910.1052 as follows:
0
A. Revise paragraph (k);
0
B. Remove the phrase ``material safety data sheets (MSDS)'' and add in 
its place the phrase ``safety data sheets (SDS)'' where it appears in 
Appendix A, Paragraph X.E.
    The revisions read as follows:


Sec.  1910.1052  Methylene chloride.

* * * * *
    (k) Hazard communication.--(1) Hazard communication--general. (i) 
Chemical manufacturers, importers, distributors and employers shall 
comply with all requirements of the Hazard Communication Standard (HCS) 
(Sec.  1910.1200) for MC.
    (ii) In classifying the hazards of MC at least the following 
hazards are to be addressed: Cancer, cardiac effects (including 
elevation of carboxyhemoglobin), central nervous system effects, liver 
effects, and skin and eye irritation.
    (iii) Employers shall include MC in the hazard communication 
program established to comply with the HCS (Sec.  1910.1200). Employers 
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 
requirements of HCS and paragraph (l) of this section.
    (2) [Reserved]
* * * * *

0
32. Amend Sec.  1910.1200 as follows:
0
A. Remove the word ``material'' before the word ``safety'' in the 
phrase ``material safety data sheet'' or ``material safety data 
sheets'' wherever they appear in paragraphs (b)(3)(ii), (b)(4)(ii), 
(e)(1) introductory text, (e)(2)(i), (g)(4), (g)(6)(i) through (iv), 
(g)(7)(i) through (vii), (g)(9), (g)(11), (h)(1), (h)(2)(iii), and 
(i)(1)(ii);
0
B. Remove the word ``Material'' before the word ``safety'' in the 
phrase ``Material safety data sheets'' wherever they appear in 
paragraphs (g)(10) and (g)(11). In paragraphs (g)(10) and (g)(11) in 
the first sentence, capitalize the first letter of the word ``safety''.
0
C. Remove the following definitions in paragraph (c) Combustible 
liquid, Compressed gas, Explosive, Flammable, Flashpoint, Hazard 
warning, Identity, Material safety data sheet (MSDS), Organic peroxide, 
Oxidizer, Pyrophoric, Unstable (reactive), and Water-reactive;
0
D. Revise the following definitions in paragraph (c) Chemical, Chemical 
name, Health hazard, Label, Mixture, Physical hazard, and Trade secret;
0
E. Redesignate the definition of the term Hazardous chemical in 
alphabetical order in paragraph (c) and revise the definition;
0
F. Add the following definitions in alphabetical order in paragraph (c) 
Classification, Hazard category, Hazard class, Hazard not otherwise 
classified, Hazard statement, Label elements, Pictogram, Precautionary 
statement, Product identifier, Pyrophoric gas, Safety Data Sheet (SDS), 
Signal word, Simple asphyxiant, and Substance;
0
G. Remove the following phrases: ``in'' before the phrase ``in their 
work area(s)''

[[Page 17786]]

in paragraph (g)(10); ``specific chemical identity'' in paragraph 
(i)(10)(ii); and ``or percentage of mixture'' in paragraph (i)(13);
0
H. Revise paragraphs (a), (b)(1), (b)(3)(iv), (b)(5)(iv), (b)(6)(ii), 
paragraph (d) (heading), paragraphs (d)(1) through (d)(3), (e)(1)(i), 
(f), paragraph (g) (heading), paragraphs (g)(1), (g)(2), (g)(3), 
(g)(5), (g)(8), (g)(11), (h)(1), (h)(3)(ii), (h)(3)(iv), (i)(1) 
introductory text, (i)(1)(iii) and (iv), (i)(2), (i)(3) introductory 
text, (i)(3)(iii), (i)(7) introductory text, (i)(7)(iii), (i)(7)(v), 
(i)(9)(i), (i)(10), (i)(11), and (j).
0
I. Remove Appendices A, B, and E to Sec.  1910.1200.
0
J. Redesignate Appendix D to Sec.  1910.1200 as Appendix E to Sec.  
1910.1200.
0
K. 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 Labelling 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 
legislative or regulatory enactments 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 
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.)
* * * * *
    (3) * * *
    (iv) Laboratory employers that ship hazardous chemicals are 
considered to be either a chemical manufacturer or a distributor under 
this rule, and thus must ensure that any containers of hazardous 
chemicals leaving the laboratory are labeled in accordance with 
paragraph (f) of this section, and that a safety data sheet is provided 
to distributors and other employers in accordance with paragraphs 
(g)(6) and (g)(7) of this section.
* * * * *
    (5) * * *
    (iv) Any distilled spirits (beverage alcohols), wine, or malt 
beverage intended for nonindustrial use, as such terms are defined in 
the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) and 
regulations issued under that Act, when subject to the labeling 
requirements of that Act and labeling regulations issued under that Act 
by the Bureau of Alcohol, Tobacco, Firearms and Explosives;
* * * * *
    (6) * * *
    (ii) Any hazardous substance as such term is defined by the 
Comprehensive Environmental Response, Compensation and Liability Act 
(CERCLA) (42 U.S.C. 9601 et seq.) when the hazardous substance is the 
focus of remedial or removal action being conducted under CERCLA in 
accordance with Environmental Protection Agency regulations.
* * * * *
    (c) * * *
    Chemical means any substance, or mixture of substances.
* * * * *
    Chemical name means the scientific designation of a chemical in 
accordance with the nomenclature system developed by the International 
Union of Pure and Applied Chemistry (IUPAC) or the Chemical Abstracts 
Service (CAS) rules of nomenclature, or a name that will clearly 
identify the chemical for the purpose of conducting a hazard 
classification.
    Classification means to identify the relevant data regarding the 
hazards of a chemical; review those data to ascertain the hazards 
associated with the chemical; and decide whether the chemical will be 
classified as hazardous according to the definition of hazardous 
chemical in this section. In addition, classification for health and 
physical hazards includes the determination of 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 four 
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 not otherwise classified (HNOC) means an adverse physical or 
health effect identified through evaluation of scientific evidence 
during the classification process that does not meet the specified 
criteria for the physical and health hazard classes addressed in this 
section. This does not extend coverage to adverse physical and health 
effects for which there is a hazard class addressed in this section, 
but the effect either falls below the cut-off value/concentration limit 
of the hazard class or is under a GHS hazard category that has not been 
adopted by OSHA (e.g., acute toxicity Category 5).
    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, a

[[Page 17787]]

simple asphyxiant, combustible dust, pyrophoric gas, or hazard not 
otherwise classified.
    Health hazard means 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 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 list of hazardous 
chemicals required in the written hazard communication program, the 
label and the SDS.
* * * * *
    Pyrophoric gas means a chemical in a gaseous state that will ignite 
spontaneously in air at a temperature of 130 degrees F (54.4 degrees C) 
or below.
* * * * *
    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.
    Simple asphyxiant means a substance or mixture that displaces 
oxygen in the ambient atmosphere, and can thus cause oxygen deprivation 
in those who are exposed, leading to unconsciousness and death.
* * * * *
    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.
* * * * *
    (d) Hazard classification. (1) Chemical manufacturers and importers 
shall evaluate chemicals produced in their workplaces or imported by 
them to classify the chemicals in accordance with this section. For 
each chemical, the chemical manufacturer or importer shall determine 
the hazard classes, and, where appropriate, the category of each class 
that apply to the chemical being classified. 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 
Appendices 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) When classifying mixtures they produce or import, chemical 
manufacturers and importers of mixtures may rely on the information 
provided on the current safety data sheets of the individual 
ingredients, except where the chemical manufacturer or importer knows, 
or in the exercise of reasonable diligence should know, that the safety 
data sheet misstates or omits information required by this section.
* * * * *
    (e) * * *
    (1) * * *
    (i) A list of the hazardous chemicals known to be present using a 
product identifier that is referenced on the appropriate safety data 
sheet (the list may be compiled for the workplace as a whole or for 
individual work areas); and,
* * * * *
    (f) Labels and other forms of warning--(1) Labels on shipped 
containers. The chemical manufacturer, importer, or distributor shall 
ensure that each container of hazardous chemicals leaving the workplace 
is labeled, tagged, or marked. Hazards not otherwise classified do not 
have to be addressed on the container. Where the chemical manufacturer 
or importer is required to label, tag or mark the following information 
shall be provided:
    (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) The chemical manufacturer, importer, or distributor shall 
ensure that the information provided under paragraphs (f)(1)(i) through 
(v) of this section is in accordance with Appendix

[[Page 17788]]

C to Sec.  1910.1200, 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).
    (3) The chemical manufacturer, importer, or distributor shall 
ensure that the information provided under paragraphs (f)(1)(ii) 
through (iv) of this section is located together on the label, tag, or 
mark.
    (4) Solid materials. (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).
    (5) 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.
    (6) Workplace labeling. Except as provided in paragraphs (f)(7) and 
(f)(8) 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 paragraphs (f)(1)(i) through 
(v) of this section 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.
    (7) 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)(6) 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.
    (8) 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.
    (9) 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.
    (10) 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.
    (11) Chemical manufacturers, importers, distributors, or employers 
who become newly aware of any significant information regarding the 
hazards of a chemical shall revise the labels for the chemical within 
six months of becoming aware of the new information, and shall ensure 
that labels on containers of hazardous chemicals shipped after that 
time contain the new information. 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) Safety data sheets. (1) Chemical manufacturers and importers 
shall obtain or develop a safety data sheet for each hazardous chemical 
they produce or import. Employers shall have a safety data sheet in the 
workplace for each hazardous chemical which they use.
    (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 at least 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;
    (xii) Section 12, Ecological information;
    (xiii) Section 13, Disposal considerations;
    (xiv) Section 14, Transport information;
    (xv) Section 15, Regulatory information; and
    (xvi) Section 16, Other information, including date of preparation 
or last revision.
    Note 1 to paragraph (g)(2): To be consistent with the GHS, an SDS 
must also include the headings in paragraphs (g)(2)(xii) through 
(g)(2)(xv) in order.
    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.
    (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

[[Page 17789]]

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.
* * * * *
    (8) The employer shall maintain in the workplace copies of the 
required safety data sheets for each hazardous chemical, and shall 
ensure that they are readily accessible during each work shift to 
employees when they are in their work area(s). (Electronic access and 
other alternatives to maintaining paper copies of the safety data 
sheets are permitted as long as no barriers to immediate employee 
access in each workplace are created by such options.)
* * * * *
    (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 Sec.  
1910.1020(e).
    (h) * * *
    (1) Employers shall provide employees with effective information 
and training on hazardous chemicals in their work area at the time of 
their initial assignment, and whenever a new chemical hazard the 
employees have not previously been trained about is introduced into 
their work area. Information and training may be designed to cover 
categories of hazards (e.g., flammability, carcinogenicity) or specific 
chemicals. Chemical-specific information must always be available 
through labels and safety data sheets.
* * * * *
    (3) * * *
    (ii) The physical, health, simple asphyxiation, combustible dust, 
and pyrophoric gas hazards, as well as hazards not otherwise 
classified, of the chemicals in the work area;
* * * * *
    (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 their 
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 (concentration) 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 (i).
    (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.
* * * * *
    (j) Effective dates. (1) Employers shall train employees regarding 
the new label elements and safety data sheets format by December 1, 
2013.
    (2) Chemical manufacturers, importers, distributors, and employers

[[Page 17790]]

shall be in compliance with all modified provisions of this section no 
later than June 1, 2015, except:
    (i) After December 1, 2015, the distributor shall not ship 
containers labeled by the chemical manufacturer or importer unless the 
label has been modified to comply with paragraph (f)(1) of this 
section.
    (ii) All employers shall, as necessary, update any alternative 
workplace labeling used under paragraph (f)(6) of this section, update 
the hazard communication program required by paragraph (h)(1), and 
provide any additional employee training in accordance with paragraph 
(h)(3) for newly identified physical or health hazards no later than 
June 1, 2016.
    (3) Chemical manufacturers, importers, distributors, and employers 
may comply with either Sec.  1910.1200 revised as of October 1, 2011, 
or the current version of this standard, or both during the 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.
    A.0.2.3 The term ``scientifically validated'' refers to the 
process by which the reliability and the relevance of a procedure 
are established for a particular purpose. Any test that determines 
hazardous properties, which is conducted according to recognized 
scientific principles, can be used for purposes of a hazard 
determination for health hazards. Test conditions need to be 
standardized so that the results are reproducible with a given 
substance, and the standardized test yields ``valid'' data for 
defining the hazard class of concern.
    A.0.2.4 Existing test data are acceptable for classifying 
chemicals, although expert judgment also may be needed for 
classification purposes.
    A.0.2.5 The effect of a chemical on biological systems is 
influenced, by the physico-chemical properties of the substance and/
or ingredients of the mixture and the way in which ingredient 
substances are biologically available. A chemical need not be 
classified when it can be shown by conclusive experimental data from 
scientifically validated test methods that the chemical is not 
biologically available.
    A.0.2.6 For classification purposes, epidemiological data and 
experience on the effects of chemicals on humans (e.g., occupational 
data, data from accident databases) shall be taken into account in 
the evaluation of human health hazards of a chemical.

A.0.3 Classification Based on Weight of Evidence

    A.0.3.1 For some hazard classes, classification results directly 
when the data satisfy the criteria. For others, classification of a 
chemical shall be determined on the basis of the total weight of 
evidence using expert judgment. This means that all available 
information bearing on the classification of hazard shall be 
considered together, including the results of valid in vitro tests, 
relevant animal data, and human experience such as epidemiological 
and clinical studies and well-documented case reports and 
observations.
    A.0.3.2 The quality and consistency of the data shall be 
considered. Information on chemicals related to the material being 
classified shall be considered as appropriate, as well as site of 
action and mechanism or mode of action study results. Both positive 
and negative results shall be considered together in a single 
weight-of-evidence determination.
    A.0.3.3 Positive effects which are consistent with the criteria 
for classification, whether seen in humans or animals, shall 
normally justify classification. Where evidence is available from 
both humans and animals and there is a conflict between the 
findings, the quality and reliability of the evidence from both 
sources shall be evaluated in order to resolve the question of 
classification. Reliable, good quality human data shall generally 
have precedence over other data. However, even well-designed and 
conducted epidemiological studies may lack a sufficient number of 
subjects to detect relatively rare but still significant effects, or 
to assess potentially confounding factors. Therefore, positive 
results from well-conducted animal studies are not necessarily 
negated by the lack of positive human experience but require an 
assessment of the robustness, quality and statistical power of both 
the human and animal data.
    A.0.3.4 Route of exposure, mechanistic information, and 
metabolism studies are pertinent to determining the relevance of an 
effect in humans. When such information raises doubt about relevance 
in humans, a lower classification may be warranted. When there is 
scientific evidence demonstrating that the mechanism or mode of 
action is not relevant to humans, the chemical should not be 
classified.
    A.0.3.5 Both positive and negative results are considered 
together in the weight of evidence determination. However, a single 
positive study performed according to good scientific principles and 
with statistically and biologically significant positive results may 
justify classification.

A.0.4 Considerations for the Classification of Mixtures

    A.0.4.1 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 those data;
    (b) Where test data are not available for the mixture itself, 
the bridging principles designated in each health hazard chapter of 
this appendix shall be considered for classification of the mixture;
    (c) If test data are not available for the mixture itself, and 
the available information is not sufficient to allow application of 
the above-mentioned bridging principles, then the method(s) 
described in each chapter for estimating the hazards based on the 
information known will be applied to classify the mixture (e.g., 
application of cut-off values/concentration limits).
    A.0.4.2 An exception to the above order or precedence is made 
for Carcinogenicity, Germ Cell Mutagenicity, and Reproductive 
Toxicity. For these three hazard classes, mixtures shall be 
classified based upon information on the ingredient substances, 
unless on a case-by-case basis, justification can be provided for 
classifying based upon the mixture as a whole. See chapters A.5, 
A.6, and A.7 for further information on case-by-case bases.
    A.0.4.3 Use of cut-off values/concentration limits.
    A.0.4.3.1 When classifying an untested mixture based on the 
hazards of its ingredients, cut-off values/concentration limits for 
the classified ingredients of the mixture are used for several 
hazard classes. While the adopted cut-off values/concentration 
limits adequately identify the hazard for most mixtures, there may 
be some that contain hazardous ingredients at lower concentrations 
than the specified cut-off values/concentration limits that still 
pose an identifiable hazard. There may also be cases where the cut-
off value/concentration limit is considerably lower than the 
established non-hazardous level for an ingredient.
    A.0.4.3.2 If the classifier has information that the hazard of 
an ingredient will be evident (i.e., it presents a health risk) 
below the specified cut-off value/concentration limit, the mixture 
containing that ingredient shall be classified accordingly.
    A.0.4.3.3 In exceptional cases, conclusive data may demonstrate 
that the hazard of an ingredient will not be evident (i.e., it does 
not present a health risk) when present at a level above the 
specified cut-off value/concentration limit(s). In these cases the 
mixture may be classified according to those data. The data must 
exclude the possibility that the ingredient will behave in the 
mixture in a manner that would increase the hazard over that of the 
pure substance. Furthermore, the mixture must not contain 
ingredients that would affect that determination.

[[Page 17791]]

    A.0.4.4 Synergistic or antagonistic effects.
    When performing an assessment in accordance with these 
requirements, the evaluator must take into account all available 
information about the potential occurrence of synergistic effects 
among the ingredients of the mixture. Lowering classification of a 
mixture to a less hazardous category on the basis of antagonistic 
effects may be done only if the determination is supported by 
sufficient data.

A.0.5 Bridging Principles for the Classification of Mixtures Where Test 
Data Are Not Available for the Complete Mixture

    A.0.5.1 Where the mixture itself has not been tested to 
determine its toxicity, but there are sufficient data on both the 
individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data shall be used in 
accordance with the following bridging principles, subject to any 
specific provisions for mixtures for each hazard class. These 
principles ensure that the classification process uses the available 
data to the greatest extent possible in characterizing the hazards 
of the mixture.
    A.0.5.1.1 Dilution.
    For mixtures classified in accordance with A.1 through A.10 of 
this Appendix, if a tested mixture is diluted with a diluent that 
has an equivalent or lower toxicity classification than the least 
toxic original ingredient, and which is not expected to affect the 
toxicity of other ingredients, then:
    (a) The new diluted mixture shall be classified as equivalent to 
the original tested mixture; or
    (b) For classification of acute toxicity in accordance with A.1 
of this Appendix, paragraph A.1.3.6 (the additivity formula) shall 
be applied.
    A.0.5.1.2 Batching.
    For mixtures classified in accordance with A.1 through A.10 of 
this Appendix, the toxicity of a tested production batch of a 
mixture can be assumed to be substantially equivalent to that of 
another untested production batch of the same mixture, when produced 
by or under the control of the same chemical manufacturer, unless 
there is reason to believe there is significant variation such that 
the toxicity of the untested batch has changed. If the latter 
occurs, a new classification is necessary.
    A.0.5.1.3 Concentration of mixtures.
    For mixtures classified in accordance with A.1, A.2, A.3, A.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.

 Table A.1.1--Acute Toxicity Hazard Categories and Acute Toxicity Estimate (ATE) Values Defining the Respective
                                                   Categories
----------------------------------------------------------------------------------------------------------------
          Exposure route             Category 1         Category 2           Category 3           Category 4
----------------------------------------------------------------------------------------------------------------
Oral (mg/kg bodyweight)
    see: Note (a), Note (b)......             <=5  >5 and <=50........  >50 and <=300......  >300 and <=2000.
Dermal (mg/kg bodyweight)
    see: Note (a), Note (b)......             <=5  >50 and <=200......  >200 and <=1000....  >1000 and <=2000.
Inhalation--Gases (ppmV)
    see: Note (a), Note (b), Note           <=100  >100 and <=500.....  >500 and <=2500....  >2500 and <=20000.
     (c).
Inhalation--Vapors (mg/l)
    see: Note (a), Note (b), Note           <=0.5  >0.5 and <=2.0.....  >2.0 and <=10.0....  >10.0 and <=20.0.
     (c), Note (d).
Inhalation--Dusts and Mists (mg/
 l)
    see: Note (a), Note (b), Note          <=0.05  >0.05 and <=0.5....  >0.5 and <=1.0.....  >1.0 and <=5.0.
     (c).
----------------------------------------------------------------------------------------------------------------
Note: Gas concentrations are expressed in parts per million per volume (ppmV).
Notes to Table A.1.1:
(a) The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50
  Stewardwhere available;
(b) The acute toxicity estimate (ATE) for the classification of a substance or ingredient in a mixture is
  derived using:
(i) the LD50/LC50 where available. Otherwise,
(ii) the appropriate conversion value from Table 1.2 that relates to the results of a range test, or
(iii) the appropriate conversion value from Table 1.2 that relates to a classification category;
(c) Inhalation cut-off values in the table are based on 4 hour testing exposures. Conversion of existing
  inhalation toxicity data which has been generated according to 1 hour exposure is achieved by dividing by a
  factor of 2 for gases and vapors and 4 for dusts and mists;
(d) For some substances the test atmosphere will be a vapor which consists of a combination of liquid and
  gaseous phases. For other substances the test atmosphere may consist of a vapor which is nearly all the
  gaseous phase. In these latter cases, classification is based on ppmV as follows: Category 1 (100 ppmV),
  Category 2 (500 ppmV), Category 3 (2500 ppmV), Category 4 (20000 ppmV).
The terms ``dust'', ``mist'' and ``vapor'' are defined as follows:
(i) Dust: solid particles of a substance or mixture suspended in a gas (usually air);
(ii) Mist: liquid droplets of a substance or mixture suspended in a gas (usually air);
(iii) Vapor: the gaseous form of a substance or mixture released from its liquid or solid state.


[[Page 17792]]

    A.1.2.3 The preferred test species for evaluation of acute 
toxicity by the oral and inhalation routes is the rat, while the rat 
or rabbit are preferred for evaluation of acute dermal toxicity. 
Test data already generated for the classification of chemicals 
under existing systems should be accepted when reclassifying these 
chemicals under the harmonized system. When experimental data for 
acute toxicity are available in several animal species, scientific 
judgment should be used in selecting the most appropriate 
LD50 value from among scientifically validated tests.

A.1.3 Classification Criteria for Mixtures

    A.1.3.1 The approach to classification of mixtures for acute 
toxicity is tiered, and is dependent upon the amount of information 
available for the mixture itself and for its ingredients. The flow 
chart of Figure A.1.1 indicates the process that must be followed:
[GRAPHIC] [TIFF OMITTED] TR26MR12.060


    A.1.3.2 Classification of mixtures for acute toxicity may be 
carried out for each route of exposure, but is only required for one 
route of exposure as long as this route is followed (estimated or 
tested) for all ingredients and there is no relevant evidence to 
suggest acute toxicity by multiple routes. When there is relevant 
evidence of acute toxicity by multiple routes of exposure, 
classification is to be conducted for all appropriate routes of 
exposure. All available information shall be considered. The 
pictogram and signal word used shall reflect the most severe hazard 
category; and all relevant hazard statements shall be used.
    A.1.3.3 For purposes of classifying the hazards of mixtures in 
the tiered approach:
    (a) The ``relevant ingredients'' of a mixture are those which 
are present in concentrations >=1% (weight/weight for solids, 
liquids, dusts, mists and vapors and volume/volume for gases). If 
there is reason to suspect that an ingredient present at a 
concentration <1% will affect classification of the mixture for 
acute toxicity, that ingredient shall also be considered relevant. 
Consideration of ingredients present at a concentration <1% is 
particularly important when classifying untested mixtures which 
contain ingredients that are classified in Category 1 and Category 
2;
    (b) Where a classified mixture is used as an ingredient of 
another mixture, the actual or derived acute toxicity estimate (ATE) 
for that mixture is used when calculating the classification of the 
new mixture using the formulas in A.1.3.6.1 and A.1.3.6.2.4.
    (c) If the converted acute toxicity point estimates for all 
ingredients of a mixture are within the same category, then the 
mixture should be classified in that category.
    (d) When only range data (or acute toxicity hazard category 
information) are available for ingredients in a mixture, they may be 
converted to point estimates in accordance with Table A.1.2 when 
calculating the classification of the new mixture using the formulas 
in A.1.3.6.1 and A.1.3.6.2.4.

A.1.3.4 Classification of Mixtures Where Acute Toxicity Test Data Are 
Available for the Complete Mixture

    Where the mixture itself has been tested to determine its acute 
toxicity, it is classified according to the same criteria as those 
used for substances, presented in Table A.1.1. If test data for the 
mixture are not available, the procedures presented below must be 
followed.

A.1.3.5 Classification of Mixtures Where Acute Toxicity Test Data Are 
Not Available for the Complete Mixture: Bridging Principles

    A.1.3.5.1 Where the mixture itself has not been tested to 
determine its acute toxicity, but there are sufficient data on both 
the individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data will be used in 
accordance with the following bridging principles as found in 
paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration 
of mixtures, Interpolation within one 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, or have an oral or dermal 
LD50 greater than 2000 but less than or equal to 5000 mg/
kg body weight (or the equivalent dose for inhalation);

[[Page 17793]]

    (b) Ignore ingredients that are presumed not acutely toxic 
(e.g., water, sugar);
    (c) Ignore ingredients if the data available are from a limit 
dose test (at the upper threshold for Category 4 for the appropriate 
route of exposure as provided in Table A.1.1) and do not show acute 
toxicity.
    Ingredients that fall within the scope of this paragraph are 
considered to be ingredients with a known acute toxicity estimate 
(ATE). See note (b) to Table A.1.1 and paragraph A.1.3.3 for 
appropriate application of available data to the equation below, and 
paragraph A.1.3.6.2.4.
    The ATE of the mixture is determined by calculation from the ATE 
values for all relevant ingredients according to the following 
formula below for oral, dermal or inhalation toxicity:
[GRAPHIC] [TIFF OMITTED] TR26MR12.061

Where:

Ci = concentration of ingredient i
n ingredients and i is running from 1 to n
ATEi = acute toxicity estimate of ingredient i.

    A.1.3.6.2 Data are not available for one or more ingredients of 
the mixture.
    A.1.3.6.2.1 Where an ATE is not available for an individual 
ingredient of the mixture, but available information provides a 
derived conversion value, the formula in A.1.3.6.1 may be applied. 
This information may include evaluation of:
    (a) Extrapolation between oral, dermal and inhalation acute 
toxicity estimates. Such an evaluation requires appropriate 
pharmacodynamic and pharmacokinetic data;
    (b) Evidence from human exposure that indicates toxic effects 
but does not provide lethal dose data;
    (c) Evidence from any other toxicity tests/assays available on 
the substance that indicates toxic acute effects but does not 
necessarily provide lethal dose data; or
    (d) Data from closely analogous substances using structure/
activity relationships.
    A.1.3.6.2.2 This approach requires substantial supplemental 
technical information, and a highly trained and experienced expert, 
to reliably estimate acute toxicity. If sufficient information is 
not available to reliably estimate acute toxicity, proceed to the 
provisions of A.1.3.6.2.3.
    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%, and the 
mixture has not been classified based on testing of the mixture as a 
whole, the mixture cannot be attributed a definitive acute toxicity 
estimate. In this situation the mixture is classified based on the 
known ingredients only. (Note: A statement that x percent of the 
mixture consists of ingredient(s) of unknown toxicity is required on 
the label and safety data sheet in such cases; see Appendix C to 
this section, Allocation of Label Elements and Appendix D to this 
section, Safety Data Sheets.)
    Where an ingredient with unknown acute toxicity is used in a 
mixture at a concentration >=1%, and the mixture is not classified 
based on testing of the mixture as a whole, a statement that X% of 
the mixture consists of ingredient(s) of unknown acute toxicity is 
required on the label and safety data sheet in such cases; see 
Appendix C to this section, Allocation of Label Elements and 
Appendix D to this section, Safety Data Sheets.)
    A.1.3.6.2.4 If the total concentration of the relevant 
ingredient(s) with unknown acute toxicity is <=10% then the formula 
presented in A.1.3.6.1 must be used. If the total concentration of 
the relevant ingredient(s) with unknown acute toxicity is >10%, the 
formula presented in A.1.3.6.1 is corrected to adjust for the 
percentage of the unknown ingredient(s) as follows:
[GRAPHIC] [TIFF OMITTED] TR26MR12.062


   Table A.1.2--Conversion From Experimentally Obtained Acute Toxicity
  Range Values (or Acute Toxicity Hazard Categories) to Acute Toxicity
    Point Estimates for Use in the Formulas for the Classification of
                                Mixtures
------------------------------------------------------------------------
                                 Classification category
                                    or experimentally        Converted
        Exposure routes               obtained acute      acute toxicity
                                 toxicity range estimate  point estimate
------------------------------------------------------------------------
Oral (mg/kg bodyweight ).......  0 =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.2.2.2 Irritation

    A.2.2.2.1 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
------------------------------------------------------------------------
                                                Criteria
------------------------------------------------------------------------
Irritant (Category 2)........  (1) Mean value of >=2.3 <=4.0 for
                                erythema/eschar or for edema in at least
                                2 of 3 tested animals from gradings at
                                24, 48 and 72 hours after patch removal
                                or, if reactions are delayed, from
                                grades on 3 consecutive days after the
                                onset of skin reactions; or
                               (2) Inflammation that persists to the end
                                of the observation period normally 14
                                days in at least 2 animals, particularly
                                taking into account alopecia (limited
                                area), hyperkeratosis, hyperplasia, and
                                scaling; or
                               (3) In some cases where there is
                                pronounced variability of response among
                                animals, with very definite positive
                                effects related to chemical exposure in
                                a single animal but less than the
                                criteria above.
------------------------------------------------------------------------

    A.2.2.2.2 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.2.2.2.3 Reversibility of skin lesions is another consideration 
in evaluating irritant responses. When inflammation persists to the 
end of the observation period in 2 or more test animals, taking into 
consideration alopecia (limited area), hyperkeratosis, hyperplasia 
and scaling, then a chemical should be considered to be an irritant.

A.2.3 Classification Criteria for Substances Using Other Data Elements

    A.2.3.1 Existing human and animal data including information 
from single or repeated exposure should be the first line of 
analysis, as they give information directly relevant to effects on 
the skin. If a substance is highly toxic by the dermal route, a skin 
corrosion/irritation study may not be practicable since the amount 
of test substance to be applied would considerably exceed the toxic 
dose and, consequently, would result in the death of the animals. 
When observations are made of skin corrosion/irritation in acute 
toxicity studies and are observed up through the limit dose, these 
data may be used for classification provided that the dilutions used 
and species tested are equivalent. In vitro alternatives that have 
been scientifically validated shall be used to make classification 
decisions. Solid substances (powders) may become corrosive or 
irritant when moistened or in contact with moist skin or mucous 
membranes. Likewise, pH extremes like <=2 and >=11.5 may indicate 
skin effects, especially when associated with significant buffering 
capacity. Generally, such substances are expected to produce 
significant effects on the skin. In the absence of any other 
information, a substance is considered corrosive (Skin Category 1) 
if it has a pH <=2 or a pH >=11.5. However, if consideration of 
alkali/acid reserve suggests the substance or mixture may not be 
corrosive despite the low or high pH value, then further evaluation 
may be necessary. In some cases enough information may be available 
from structurally related compounds to make classification 
decisions.
    A.2.3.2 A tiered approach to the evaluation of initial 
information shall be used (Figure A.2.1) recognizing that all 
elements may not be relevant in certain cases.
    A.2.3.3 The tiered approach explains how to organize information 
on a substance and to make a weight-of-evidence decision about 
hazard assessment and hazard classification.
    A.2.3.4 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

[[Page 17795]]

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. 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.
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[[Page 17797]]


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BILLING CODE 4510-26-C

A.2.4 Classification Criteria for Mixtures

A.2.4.1 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    A.2.4.1.1 The mixture shall be classified using the criteria for 
substances (See A.2.3).

A.2.4.2 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.2.4.2.1 Where the mixture itself has not been tested to 
determine its skin corrosion/irritation, 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.2.4.3 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.2.4.3.1 For purposes of classifying the skin corrosion/
irritation hazards of mixtures in the tiered approach:
    The ``relevant ingredients'' of a mixture are those which are 
present in concentrations >1% (weight/weight for solids, liquids, 
dusts, mists and vapors and volume/volume for gases.) If the 
classifier has reason to suspect that an ingredient present at a 
concentration <1% will affect classification of the mixture for skin 
corrosion/irritation, that ingredient shall also be considered 
relevant.
    A.2.4.3.2 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.2.4.3.3 Table A.2.3 below provides the cut-off value/
concentration limits to be used to determine if the mixture is 
considered to be an irritant or a corrosive to the skin.
    A.2.4.3.4 Particular care shall be taken when classifying 
certain types of chemicals such as acids and bases, inorganic salts, 
aldehydes, phenols, and surfactants. The approach explained in 
A.2.4.3.1 and A.2.4.3.2 might not work given that many of such 
substances are corrosive or irritant at concentrations <1%. For 
mixtures containing strong acids or bases the pH should be used as 
classification criteria since pH will be a better indicator of 
corrosion than the concentration limits 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.2.4.3.5 On occasion, reliable data may show that the skin 
corrosion/irritation of an ingredient will not be evident when 
present at a level above the generic concentration cut-off values 
mentioned in Tables A.2.3 and A.2.4. In these cases the mixture 
could be classified according to those data (See Use of cut-off 
values/concentration limits, paragraph A.0.4.3 of this Appendix).
    A.2.4.3.6 If there are data showing that (an) ingredient(s) may 
be corrosive or irritant at a concentration of <1% (corrosive) or 
<3% (irritant), the mixture shall be classified accordingly (See Use 
of cut-off values/concentration limits, paragraph A.0.4.3 of this 
Appendix).

[[Page 17798]]



  Table A.2.3--Concentration of Ingredients of a Mixture Classified as
Skin Category 1 or 2 That Would Trigger Classification of the Mixture as
                            Hazardous to Skin
                            [Category 1 or 2]
------------------------------------------------------------------------
                                Concentration triggering classification
                                            of a mixture as:
Sum of ingredients classified ------------------------------------------
             as:                 Skin corrosive        Skin irritant
                              ------------------------------------------
                                   Category 1            Category 2
------------------------------------------------------------------------
Skin Category 1..............                >=5%  >=1% but <5%.
Skin Category 2..............  ..................  >=10%.
(10 x Skin Category 1) + Skin  ..................  >=10%.
 Category 2.
------------------------------------------------------------------------


  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
         Ingredient:             Concentration:          as:  Skin
------------------------------------------------------------------------
Acid with pH <=2.............                >=1%  Category 1.
Base with pH >=11.5..........                >=1%  Category 1.
Other corrosive (Category 1)                 >=1%  Category 1.
 ingredients for which
 additivity does not apply.
Other irritant (Category 2)                  >=3%  Category 2.
 ingredients for which
 additivity does not apply,
 including acids and bases.
------------------------------------------------------------------------

A.3 SERIOUS EYE DAMAGE/EYE IRRITATION

A.3.1 Definitions and General Considerations

    A.3.1.1 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.3.1.2 Serious eye damage/eye irritation shall be classified 
using a tiered approach as detailed in Figure A.3.1. Emphasis shall 
be placed upon existing human data (See A.0.2.6), followed by animal 
data, followed by other sources of information. Classification 
results directly when the data satisfy the criteria in this section. 
In case the criteria cannot be directly applied, classification of a 
substance or a mixture is made on the basis of the total weight of 
evidence (See A.0.3.1). This means that all available information 
bearing on the determination of serious eye damage/eye irritation is 
considered together, including the results of appropriate 
scientifically validated in vitro tests, relevant animal data, and 
human data such as epidemiological and clinical studies and well-
documented case reports and observations.

A.3.2 Classification Criteria for Substances Using Animal 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 and/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.

                  Table A.3.1--Irreversible Eye Effects
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
A substance is classified as Serious Eye Damage Category 1 (irreversible
 effects on the eye) when it produces:
    (a) at least in one tested animal, effects on the cornea, iris or
     conjunctiva that are not expected to reverse or have not fully
     reversed within an observation period of normally 21 days; and/or
    (b) at least in 2 of 3 tested animals, a positive response of:
        (i) corneal opacity >=3; and/or
        (ii) iritis >1.5;
        calculated as the mean scores following grading at 24, 48 and 72
         hours after instillation of the substance.
------------------------------------------------------------------------

    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.

                   Table A.3.2--Reversible Eye Effects
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
A substance is classified as Eye irritant Category 2A (irritating to
 eyes) when it produces in at least in 2 of 3 tested animals a positive
 response of:
    (i) corneal opacity >=1; and/or
    (ii) iritis >=1; and/or
    (iii) conjunctival redness >=2; and/or
    (iv) conjunctival edema (chemosis) >=2

[[Page 17799]]

 
    calculated as the mean scores following grading at 24, 48 and 72
     hours after instillation of the substance, and which fully reverses
     within an observation period of normally 21 days.
An eye irritant is considered mildly irritating to eyes (Category 2B)
 when the effects listed above are fully reversible within 7 days of
 observation.
------------------------------------------------------------------------

    A.3.2.3 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 Existing human and animal data should be the first line 
of analysis, as they give information directly relevant to effects 
on the eye. Possible skin corrosion shall be evaluated prior to 
consideration of 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 scientifically validated and 
accepted shall be used to make classification decisions. Likewise, 
pH extremes like <=2 and >=11.5, may indicate serious eye damage, 
especially when associated with significant buffering capacity. 
Generally, such substances are expected to produce significant 
effects on the eyes. In the absence of any other information, a 
mixture/substance is considered to cause serious eye damage (Eye 
Category 1) if it has a pH <=2 or >=11.5. However, if consideration 
of acid/alkaline reserve suggests the substance may not have the 
potential to cause serious eye damage despite the low or high pH 
value, then further evaluation may be necessary. In some cases 
enough information may be available from structurally related 
compounds to make classification decisions.
    A.3.3.2 A tiered approach to the evaluation of initial 
information shall be used where applicable, recognizing that all 
elements may not be relevant in certain cases (Figure A.3.1).
    A.3.3.3 The tiered approach explains how to organize existing 
information on a substance and to make a weight-of-evidence 
decision, where appropriate, about hazard assessment and hazard 
classification.
    A.3.3.4 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, 
consideration should be given to the totality of existing 
information and making an overall weight-of-evidence determination. 
This is especially true when there is conflict in information 
available on some parameters.
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[[Page 17801]]


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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.
    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, chemical 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. In the 
absence of any other information, a mixture is considered to cause 
serious eye damage (Eye Category 1) if it has a pH <=2 or >=11.5. 
However, if consideration of acid/alkaline 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 evaluation may 
be necessary.

A.3.4.2 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.3.4.2.1 Where the mixture itself has not been tested to 
determine its skin corrosivity or potential to cause serious eye 
damage or eye irritation, but there are sufficient data on both the 
individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data will be used in 
accordance with the following bridging principles, as found in 
paragraph A.0.5 of this Appendix: Dilution, Batching, Concentration 
of mixtures, Interpolation within one 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 For purposes of classifying the eye corrosion/
irritation hazards of mixtures in the tiered approach:
    The ``relevant ingredients'' of a mixture are those which are 
present in concentrations >1% (weight/weight for solids, liquids, 
dusts, mists and vapors and volume/volume for gases). If the 
classifier has reason to suspect that an ingredient present at a 
concentration <1% will affect classification of the mixture for eye 
corrosion/irritation, that ingredient shall also be considered 
relevant.
    A.3.4.3.2 In general, the approach to classification of mixtures 
as seriously damaging to the eye or eye irritant when data are 
available on the ingredients, but not on the mixture as a whole, is 
based on the theory of additivity, such that each 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 
as seriously damaging to the eye or an eye irritant.
    A.3.4.3.4 Particular care must be taken when classifying certain 
types of chemicals such as acids and bases, inorganic salts, 
aldehydes, phenols, and surfactants. The approach explained in 
A.3.4.3.1 and A.3.4.3.2 might not work given that many of such 
substances are 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 cut-off values/concentration limits''). On 
occasion, when it is expected that the skin corrosion/irritation or 
the reversible/irreversible eye effects of an ingredient will not be 
evident when present at a level above the generic concentration/cut-
off levels mentioned in Tables A.3.3 and A.3.4, testing of the 
mixture may be considered. In those cases, the tiered weight of 
evidence 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 cut-off values/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%.

[[Page 17802]]

 
Eye Category 2.........................  ...........................  >=10%.
(10 x Eye Category 1) + Eye Category 2.  ...........................  >=10%.
Skin Category 1 + Eye Category 1.......                         >=3%  >=1% but <3%.
10 x (Skin Category 1 + Eye Category 1)  ...........................  >=10%.
 + Eye Category 2.
----------------------------------------------------------------------------------------------------------------
Note: A mixture may be classified as Eye Category 2B in cases when all relevant ingredients are classified as
  Eye Category 2B.


  Table A.3.4--Concentration of Ingredients of a Mixture for Which the
Additivity Approach Does Not Apply, That Would Trigger Classification of
                   the Mixture as Hazardous to the Eye
------------------------------------------------------------------------
                                                    Mixture  classified
          Ingredient              Concentration           as: Eye
------------------------------------------------------------------------
Acid with pH <=2..............               >=1%  Category 1.
Base with pH >=11.5...........               >=1%  Category 1.
Other corrosive (Category 1)                 >=1%  Category 1.
 ingredients for which
 additivity does not apply.
Other irritant (Category 2)                  >=3%  Category 2.
 ingredients for which
 additivity does not apply,
 including acids and bases.
------------------------------------------------------------------------

A.4 RESPIRATORY OR SKIN SENSITIZATION

A.4.1 Definitions and General Considerations

    A.4.1.1 Respiratory sensitizer means a chemical that will lead 
to hypersensitivity of the airways following inhalation of the 
chemical.
    Skin sensitizer means a chemical that will lead to an allergic 
response following skin contact.
    A.4.1.2 For the purpose of this chapter, sensitization includes 
two phases: the first phase is induction of specialized 
immunological memory in an individual by exposure to an allergen. 
The second phase is elicitation, i.e., production of a cell-mediated 
or antibody-mediated allergic response by exposure of a sensitized 
individual to an allergen.
    A.4.1.3 For respiratory sensitization, the pattern of induction 
followed by elicitation phases is shared in common with skin 
sensitization. For skin sensitization, an induction phase is 
required in which the immune system learns to react; clinical 
symptoms can then arise when subsequent exposure is sufficient to 
elicit a visible skin reaction (elicitation phase). As a 
consequence, predictive tests usually follow this pattern in which 
there is an induction phase, the response to which is measured by a 
standardized elicitation phase, typically involving a patch test. 
The local lymph node assay is the exception, directly measuring the 
induction response. Evidence of skin sensitization in humans 
normally is assessed by a diagnostic patch test.
    A.4.1.4 Usually, for both skin and respiratory sensitization, 
lower levels are necessary for elicitation than are required for 
induction.
    A.4.1.5 The hazard class ``respiratory or skin sensitization'' 
is differentiated into:
    (a) Respiratory sensitization; and
    (b) Skin sensitization.

A.4.2 Classification Criteria for Substances

A.4.2.1 Respiratory Sensitizers

    A.4.2.1.1 Hazard Categories.
    A.4.2.1.1.1 Effects seen in either humans or animals will 
normally justify classification in a weight of evidence approach for 
respiratory sensitizers. Substances may be allocated to one of the 
two sub-categories 1A or 1B using a weight of evidence approach in 
accordance with the criteria given in Table A.4.1 and on the basis 
of reliable and good quality evidence from human cases or 
epidemiological studies and/or observations from appropriate studies 
in experimental animals.
    A.4.2.1.1.2 Where data are not sufficient for sub-
categorization, respiratory sensitizers shall be classified in 
Category 1.

     Table A.4.1--Hazard Category and Sub-Categories for Respiratory
                               Sensitizers
------------------------------------------------------------------------
            Category 1                     Respiratory sensitizer
------------------------------------------------------------------------
                                    A substance is classified as a
                                     respiratory sensitizer.
                                    (a) if there is evidence in humans
                                     that the substance can lead to
                                     specific respiratory
                                     hypersensitivity and/or
                                    (b) if there are positive results
                                     from an appropriate animal test.\1\
Sub-category 1A...................  Substances showing a high frequency
                                     of occurrence in humans; or a
                                     probability of occurrence of a high
                                     sensitization rate in humans based
                                     on animal or other tests.\1\
                                     Severity of reaction may also be
                                     considered.
Sub-category 1B...................  Substances showing a low to moderate
                                     frequency of occurrence in humans;
                                     or a probability of occurrence of a
                                     low to moderate sensitization rate
                                     in humans based on animal or other
                                     tests.\1\ Severity of reaction may
                                     also be considered.
------------------------------------------------------------------------

     
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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

[[Page 17803]]

the evidence from the cases, the following be taken into account:
    (a) The size of the population exposed;
    (b) The extent of exposure.
    A.4.2.1.2.3 The evidence referred to above could be:
    (a) Clinical history and data from appropriate lung function 
tests related to exposure to the substance, confirmed by other 
supportive evidence which may include:
    (i) In vivo immunological test (e.g., skin prick test);
    (ii) In vitro immunological test (e.g., serological analysis);
    (iii) Studies that may indicate other specific hypersensitivity 
reactions where immunological mechanisms of action have not been 
proven, e.g., repeated low-level irritation, pharmacologically 
mediated effects;
    (iv) A chemical structure related to substances known to cause 
respiratory hypersensitivity;
    (b) Data from positive bronchial challenge tests with the 
substance conducted according to accepted guidelines for the 
determination of a specific hypersensitivity reaction.
    A.4.2.1.2.4 Clinical history should include both medical and 
occupational history to determine a relationship between exposure to 
a specific substance and development of respiratory 
hypersensitivity. Relevant information includes aggravating factors 
both in the home and workplace, the onset and progress of the 
disease, family history and medical history of the patient in 
question. The medical history should also include a note of other 
allergic or airway disorders from childhood and smoking history.
    A.4.2.1.2.5 The results of positive bronchial challenge tests 
are considered to provide sufficient evidence for classification on 
their own. It is, however, recognized that in practice many of the 
examinations listed above will already have been carried out.
    A.4.2.1.3 Animal studies.
    A.4.2.1.3.1 Data from appropriate animal studies \2\ which may 
be indicative of the potential of a substance to cause sensitization 
by inhalation in humans \3\ may include:
---------------------------------------------------------------------------

    \2\ At this writing, recognized and validated animal models for 
the testing of respiratory hypersensitivity are not available. Under 
certain circumstances, data from animal studies may provide valuable 
information in a weight of evidence assessment.
    \3\ The mechanisms by which substances induce symptoms of asthma 
are not yet fully known. For preventive measures, these substances 
are considered respiratory sensitizers. However, if on the basis of 
the evidence, it can be demonstrated that these substances induce 
symptoms of asthma by irritation only in people with bronchial 
hyperactivity, they should not be considered as respiratory 
sensitizers.
---------------------------------------------------------------------------

    (a) Measurements of Immunoglobulin E (IgE) and other specific 
immunological parameters, for example in mice
    (b) Specific pulmonary responses in guinea pigs.

A.4.2.2 Skin Sensitizers

    A.4.2.2.1 Hazard categories.
    A.4.2.2.1.1 Effects seen in either humans or animals will 
normally justify classification in a weight of evidence approach for 
skin sensitizers. Substances may be allocated to one of the two sub-
categories 1A or 1B using a weight of evidence approach in 
accordance with the criteria given in Table A.4.2 and on the basis 
of reliable and good quality evidence from human cases or 
epidemiological studies and/or observations from appropriate studies 
in experimental animals according to the guidance values provided in 
A.4.2.2.2.1 and A.4.2.2.3.2 for sub-category 1A and in A.4.2.2.2.2 
and A.4.2.2.3.3 for sub-category 1B.
    A.4.2.2.1.2 Where data are not sufficient for sub-
categorization, skin sensitizers shall be classified in Category 1.

  Table A.4.2--Hazard Category and Sub-Categories for Skin Sensitizers
------------------------------------------------------------------------
            Category 1                         Skin sensitizer
------------------------------------------------------------------------
                                    A substance is classified as a skin
                                     sensitizer.
                                    (a) if there is evidence in humans
                                     that the substance can lead to
                                     sensitization by skin contact in a
                                     substantial number of persons, or
                                    (b) if there are positive results
                                     from an appropriate animal test.
Sub-category 1A...................  Substances showing a high frequency
                                     of occurrence in humans and/or a
                                     high potency in animals can be
                                     presumed to have the potential to
                                     produce significant sensitization
                                     in humans. Severity of reaction may
                                     also be considered.
Sub-category 1B...................  Substances showing a low to moderate
                                     frequency of occurrence in humans
                                     and/or a low to moderate potency in
                                     animals can be presumed to have the
                                     potential to produce sensitization
                                     in humans. Severity of reaction may
                                     also be considered.
------------------------------------------------------------------------

    A.4.2.2.2 Human evidence.
    A.4.2.2.2.1 Human evidence for sub-category 1A may include:
    (a) Positive responses at <=500 [mu]g/cm\2\ (Human Repeat Insult 
Patch Test (HRIPT), Human Maximization Test (HMT)--induction 
threshold);
    (b) Diagnostic patch test data where there is a relatively high 
and substantial incidence of reactions in a defined population in 
relation to relatively low exposure;
    (c) Other epidemiological evidence where there is a relatively 
high and substantial incidence of allergic contact dermatitis in 
relation to relatively low exposure.
    A.4.2.2.2.2 Human evidence for sub-category 1B may include:
    (a) Positive responses at >500 [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.\4\
---------------------------------------------------------------------------

    \4\ Test methods for skin sensitization are described in OECD 
Guideline 406 (the Guinea Pig Maximization test and the Buehler 
guinea pig test) and Guideline 429 (Local Lymph Node Assay). Other 
methods may be used provided that they are scientifically validated. 
The Mouse Ear Swelling Test (MEST), appears to be a reliable 
screening test to detect moderate to strong sensitizers, and can be 
used, in accordance with professional judgment, as a first stage in 
the assessment of skin sensitization potential.
---------------------------------------------------------------------------

    A.4.2.2.3.2 Animal test results for sub-category 1A can include 
data with values indicated in Table A.4.3 below:

          Table A.4.3--Animal Test Results for Sub-Category 1A
------------------------------------------------------------------------
            Assay                               Criteria
------------------------------------------------------------------------
Local lymph node assay.......  EC3 value <=2%.
Guinea pig maximization test.  >=30% responding at <=0.1% intradermal
                                induction dose or
                               >=60% responding at >0.1% to <=1%
                                intradermal induction dose.
Buehler assay................  >=15% responding at <=0.2% topical
                                induction dose or

[[Page 17804]]

 
                               >=60% responding at >0.2% to <=20%
                                topical induction dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
  required to induce a stimulation index of 3 in the local lymph node
  assay.

    A.4.2.2.3.3 Animal test results for sub-category 1B can include 
data with values indicated in Table A.4.4 below:

          Table A.4.4--Animal Test Results for Sub-Category 1B
------------------------------------------------------------------------
            Assay                               Criteria
------------------------------------------------------------------------
Local lymph node assay.......  EC3 value >2%.
Guinea pig maximization test.  >=30% to <60% responding at >0.1% to <=1%
                                intradermal induction dose or
                               >=30% responding at >1% intradermal
                                induction dose.
Buehler assay................  >=15% to <60% responding at >0.2% to
                                <=20% topical induction dose or
                               >=15% responding at >20% topical
                                induction dose.
------------------------------------------------------------------------
Note: EC3 refers to the estimated concentration of test chemical
  required to induce a stimulation index of 3 in the local lymph node
  assay.

    A.4.2.2.4 Specific considerations.
    A.4.2.2.4.1 For classification of a substance, evidence shall 
include one or more of the following using a weight of evidence 
approach:
    (a) Positive data from patch testing, normally obtained in more 
than one dermatology clinic;
    (b) Epidemiological studies showing allergic contact dermatitis 
caused by the substance. Situations in which a high proportion of 
those exposed exhibit characteristic symptoms are to be looked at 
with special concern, even if the number of cases is small;
    (c) Positive data from appropriate animal studies;
    (d) Positive data from experimental studies in 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.
    A.4.2.2.4.2 Evidence from animal studies is usually much more 
reliable than evidence from human exposure. However, in cases where 
evidence is available from both sources, and there is conflict 
between the results, the quality and reliability of the evidence 
from both sources must be assessed in order to resolve the question 
of classification on a case-by-case basis. Normally, human data are 
not generated in controlled experiments with volunteers for the 
purpose of hazard classification but rather as part of risk 
assessment to confirm lack of effects seen in animal tests. 
Consequently, positive human data on skin sensitization are usually 
derived from case-control or other, less defined studies. Evaluation 
of human data must, therefore, be carried out with caution as the 
frequency of cases reflect, in addition to the inherent properties 
of the substances, factors such as the exposure situation, 
bioavailability, individual predisposition and preventive measures 
taken. Negative human data should not normally be used to negate 
positive results from animal studies. For both animal and human 
data, consideration should be given to the impact of vehicle.
    A.4.2.2.4.3 If none of the above-mentioned conditions are met, 
the substance need not be classified as a skin sensitizer. However, 
a combination of two or more indicators of skin sensitization, as 
listed below, may alter the decision. This shall be considered on a 
case-by-case basis.
    (a) Isolated episodes of allergic contact dermatitis;
    (b) Epidemiological studies of limited power, e.g., where 
chance, bias or confounders have not been ruled out fully with 
reasonable confidence;
    (c) Data from animal tests, performed according to existing 
guidelines, which do not meet the criteria for a positive result 
described in A.4.2.2.3, but which are sufficiently close to the 
limit to be considered significant;
    (d) Positive data from non-standard methods;
    (e) Positive results from close structural analogues.
    A.4.2.2.4.4 Immunological contact urticaria.
    A.4.2.2.4.4.1 Substances meeting the criteria for classification 
as respiratory sensitizers may, in addition, cause immunological 
contact urticaria. Consideration shall be given to classifying these 
substances as skin sensitizers.
    A.4.2.2.4.4.2 Substances which cause immunological contact 
urticaria without meeting the criteria for respiratory sensitizers 
shall be considered for classification as skin sensitizers.
    A.4.2.2.4.4.3 There is no recognized animal model available to 
identify substances which cause immunological contact urticaria. 
Therefore, classification will normally be based on human evidence, 
similar to that for skin sensitization.

A.4.3 Classification Criteria for Mixtures

A.4.3.1 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    When reliable and good quality evidence, as described in the 
criteria for substances, from human experience or appropriate 
studies in experimental animals, is available for the mixture, then 
the mixture shall be classified by weight of evidence evaluation of 
these data. Care must be exercised in evaluating data on mixtures 
that the dose used does not render the results inconclusive.

A.4.3.2 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.4.3.2.1 Where the mixture itself has not been tested to 
determine its sensitizing properties, but there are sufficient data 
on both the individual ingredients and similar tested mixtures to 
adequately characterize the hazards of the mixture, these data will 
be used in accordance with the following agreed bridging principles 
as found in paragraph A.0.5 of this Appendix: Dilution, Batching, 
Concentration of mixtures, Interpolation, Substantially similar 
mixtures, and Aerosols.

A.4.3.3 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    The mixture shall be classified as a respiratory or skin 
sensitizer when at least one ingredient has been classified as a 
respiratory or skin sensitizer and is present at or above the 
appropriate cut-off value/concentration limit for the specific 
endpoint as shown in Table A.4.5.

[[Page 17805]]



  Table A.4.5--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Either Respiratory
                Sensitizers or Skin Sensitizers That Would Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
                                           Cut-off values/concentration limits triggering classification of a
                                                                      mixture as:
                                      --------------------------------------------------------------------------
      Ingredient classified as:                Respiratory Sensitizer Category 1             Skin Sensitizer
                                      --------------------------------------------------        Category 1
                                                                                        ------------------------
                                             Solid/liquid                 Gas              All physical states
----------------------------------------------------------------------------------------------------------------
Respiratory Sensitizer, Category 1...                   >=0.1%                   >=0.1%  .......................
Respiratory Sensitizer, Sub-category                    >=0.1%                   >=0.1%  .......................
 1A..................................
Respiratory Sensitizer, Sub-category                    >=1.0%                   >=0.2%  .......................
 1B..................................
Skin Sensitizer, Category 1..........  .......................  .......................                   >=0.1%
Skin Sensitizer, Sub-category 1A.....  .......................  .......................                   >=0.1%
Skin Sensitizer, Sub-category 1B.....  .......................  .......................                   >=1.0%
----------------------------------------------------------------------------------------------------------------

A.5 GERM CELL MUTAGENICITY

A.5.1 Definitions and General Considerations

    A.5.1.1 A mutation is defined as a permanent change in the 
amount or structure of the genetic material in a cell. The term 
mutation applies both to heritable genetic changes that may be 
manifested at the phenotypic level and to the underlying DNA 
modifications when known (including, for example, specific base pair 
changes and chromosomal translocations). The term mutagenic and 
mutagen will be used for agents giving rise to an increased 
occurrence of mutations in populations of cells and/or organisms.
    A.5.1.2 The more general terms genotoxic and genotoxicity apply 
to agents or processes which alter the structure, information 
content, or segregation of DNA, including those which cause DNA 
damage by interfering with normal replication processes, or which in 
a non-physiological manner (temporarily) alter its replication. 
Genotoxicity test results are usually taken as indicators for 
mutagenic effects.
    A.5.1.3 This hazard class is primarily concerned with chemicals 
that may cause mutations in the germ cells of humans that can be 
transmitted to the progeny. However, mutagenicity/genotoxicity tests 
in vitro and in mammalian somatic cells in vivo are also considered 
in classifying substances and mixtures within this hazard class.

A.5.2 Classification Criteria for Substances

    A.5.2.1 The classification system provides for two different 
categories of germ cell mutagens to accommodate the weight of 
evidence available. The two-category system is described in the 
Figure A.5.1.

         Figure A.5.1--Hazard Categories for Germ Cell Mutagens
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Substances known to induce heritable mutations or to be
 regarded as if they induce heritable mutations in the germ cells of
 humans.
Category 1A: Substances known to induce heritable mutations in germ
 cells of humans.
    Positive evidence from human epidemiological studies.
Category 1B: Substances which should be regarded as if they induce
 heritable mutations in the germ cells of humans.
    (a) Positive result(s) from in vivo heritable germ cell mutagenicity
     tests in mammals; or
    (b) Positive result(s) from in vivo somatic cell mutagenicity tests
     in mammals, in combination with some evidence that the substance
     has potential to cause mutations to germ cells. This supporting
     evidence may, for example, be derived from mutagenicity/
     genotoxicity tests in germ cells in vivo, or by demonstrating the
     ability of the substance or its metabolite(s) to interact with the
     genetic material of germ cells; or
    (c) Positive results from tests showing mutagenic effects in the
     germ cells of humans, without demonstration of transmission to
     progeny; for example, an increase in the frequency of aneuploidy in
     sperm cells of exposed people.
CATEGORY 2: Substances which cause concern for humans owing to the
 possibility that they may induce heritable mutations in the germ cells
 of humans.
    Positive evidence obtained from experiments in mammals and/or in
     some cases from in vitro experiments, obtained from:
        (a) Somatic cell mutagenicity tests in vivo, in mammals; or
        (b) Other in vivo somatic cell genotoxicity tests which are
         supported by positive results from in vitro mutagenicity
         assays.
            Note: Substances which are positive in in vitro mammalian
             mutagenicity assays, and which also show chemical structure
             activity relationship to known germ cell mutagens, should
             be considered for classification as Category 2 mutagens.
------------------------------------------------------------------------

    A.5.2.2 Specific considerations for classification of substances 
as germ cell mutagens:
    A.5.2.2.1 To arrive at a classification, test results are 
considered from experiments determining mutagenic and/or genotoxic 
effects in germ and/or somatic cells of exposed animals. Mutagenic 
and/or genotoxic effects determined in in vitro tests shall also be 
considered.
    A.5.2.2.2 The system is hazard based, classifying chemicals on 
the basis of their intrinsic ability to induce mutations in germ 
cells. The scheme is, therefore, not meant for the (quantitative) 
risk assessment of chemical substances.
    A.5.2.2.3 Classification for heritable effects in human germ 
cells is made on the basis of scientifically validated tests. 
Evaluation of the test results shall be done using expert judgment 
and all the available evidence shall be weighed for classification.
    A.5.2.2.4 The classification of substances shall be based on the 
total weight of evidence available, using expert judgment. In those 
instances where a single well-conducted test is used for 
classification, it shall provide clear and unambiguously positive 
results. The relevance of the route of exposure used in the study of 
the substance compared to the route of human exposure should also be 
taken into account.

A.5.3 Classification Criteria for Mixtures \5\
---------------------------------------------------------------------------

    \5\ It should be noted that the classification criteria for 
health hazards usually include a tiered scheme in which test data 
available on the complete mixture are considered as the first tier 
in the evaluation, followed by the applicable bridging principles, 
and lastly, cut-off values/concentration limits or additivity. 
However, this approach is not used for Germ Cell Mutagenicity. These 
criteria for Germ Cell Mutagenicity consider the cut-off values/
concentration limits as the primary tier and allow the 
classification to be modified only on a case-by-case evaluation 
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------

A.5.3.1 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.5.3.1.1 Classification of mixtures shall be based on the 
available test data for the

[[Page 17806]]

individual ingredients of the mixture using cut-off values/
concentration limits for the ingredients classified as germ cell 
mutagens.
    A.5.3.1.2 The mixture will be classified as a mutagen when at 
least one ingredient has been classified as a Category 1A, Category 
1B or Category 2 mutagen and is present at or above the appropriate 
cut-off value/concentration limit as shown in Table A.5.1 below for 
Category 1 and 2 respectively.

  Table A.5.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Germ Cell Mutagens
                                That Would Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
                                                                     Cut-off/concentration limits triggering
                                                                         classification of a mixture as:
                   Ingredient classified as:                   -------------------------------------------------
                                                                   Category 1 mutagen       Category 2 mutagen
----------------------------------------------------------------------------------------------------------------
Category 1A/B mutagen.........................................                   >=0.1%  .......................
Category 2 mutagen............................................  .......................                   >=1.0%
----------------------------------------------------------------------------------------------------------------
Note: The cut-off values/concentration limits in the table above apply to solids and liquids (w/w units) as well
  as gases (v/v units).

A.5.3.2 Classification of Mixtures When Data Are Available for the 
Mixture Itself

    The classification may be modified on a case-by-case basis based 
on the available test data for the mixture as a whole. In such 
cases, the test results for the mixture as a whole must be shown to 
be conclusive taking into account dose and other factors such as 
duration, observations and analysis (e.g. statistical analysis, test 
sensitivity) of germ cell mutagenicity test systems.

A.5.3.3 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.5.3.3.1 Where the mixture itself has not been tested to 
determine its germ cell mutagenicity hazard, but there are 
sufficient data on both the individual ingredients and similar 
tested mixtures to adequately characterize the hazards of the 
mixture, these data will be used in accordance with the following 
bridging principles as found in paragraph A.0.5 of this Appendix: 
Dilution, Batching, and Substantially similar mixtures.

A.5.4 Examples of Scientifically Validated Test Methods

A.5.4.1 Examples of in vivo heritable germ cell mutagenicity tests 
are:
    (a) Rodent dominant lethal mutation test (OECD 478)
    (b) Mouse heritable translocation assay (OECD 485)
    (c) Mouse specific locus test
A.5.4.2 Examples of in vivo somatic cell mutagenicity tests are:
    (a) Mammalian bone marrow chromosome aberration test (OECD 475)
    (b) Mouse spot test (OECD 484)
    (c) Mammalian erythrocyte micronucleus test (OECD 474)
A.5.4.3 Examples of mutagenicity/genotoxicity tests in germ cells 
are:
    (a) Mutagenicity tests:
    (i) Mammalian spermatogonial chromosome aberration test (OECD 
483)
    (ii) Spermatid micronucleus assay
    (b) Genotoxicity tests:
    (i) Sister chromatid exchange analysis in spermatogonia
    (ii) Unscheduled DNA synthesis test (UDS) in testicular cells
A.5.4.4 Examples of genotoxicity tests in somatic cells are:
    (a) Liver Unscheduled DNA Synthesis (UDS) in vivo (OECD 486)
    (b) Mammalian bone marrow Sister Chromatid Exchanges (SCE)
A.5.4.5 Examples of in vitro mutagenicity tests are:
    (a) In vitro mammalian chromosome aberration test (OECD 473)
    (b) In vitro mammalian cell gene mutation test (OECD 476)
    (c) Bacterial reverse mutation tests (OECD 471)
A.5.4.6 As new, scientifically validated tests arise, these may also 
be used in the total weight of evidence to be considered.

A.6 CARCINOGENICITY

A.6.1 Definitions

    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 6
---------------------------------------------------------------------------

    \6\ See Non-mandatory Appendix F Part A for further guidance 
regarding hazard classification for carcinogenicity. This appendix 
is consistent with the GHS adn is provided as guidance excerpted 
from the International Agency for Research on Cancer (IARC) 
``Monographs on the Evaluation of Carcinogenic Risks to Humans'' 
(2006).
---------------------------------------------------------------------------

    A.6.2.1 For the purpose of classification for carcinogenicity, 
substances are allocated to one of two categories based on strength 
of evidence and additional weight of evidence considerations. In 
certain instances, route-specific classification may be warranted.

             Figure A.6.1--Hazard Categories for Carcinogens
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Known or presumed human carcinogens.
    The classification of a substance as a Category 1 carcinogen is done
     on the basis of epidemiological and/or animal data. This
     classification is further distinguished on the basis of whether the
     evidence for classification is largely from human data (Category
     1A) or from animal data (Category 1B):
Category 1A: Known to have carcinogenic potential for humans.
 Classification in this category is largely based on human evidence.
Category 1B: Presumed to have carcinogenic potential for humans.
 Classification in this category is largely based on animal evidence.
    The classification of a substance in Category 1A and 1B is based on
     strength of evidence together with weight of evidence
     considerations (See paragraph A.6.2.5). Such evidence may be
     derived from:
        --human studies that establish a causal relationship between
         human exposure to a substance and the development of cancer
         (known human carcinogen); or
        --animal experiments for which there is sufficient evidence to
         demonstrate animal carcinogenicity (presumed human carcinogen).
    In addition, on a case by case basis, scientific judgment may
     warrant a decision of presumed human carcinogenicity derived from
     studies showing limited evidence of carcinogenicity in humans
     together with limited evidence of carcinogenicity in experimental
     animals.
CATEGORY 2: Suspected human carcinogens.

[[Page 17807]]

 
    The classification of a substance in Category 2 is done on the basis
     of evidence obtained from human and/or animal studies, but which is
     not sufficiently convincing to place the substance in Category 1A
     or B. This classification is based on strength of evidence together
     with weight of evidence considerations (See paragraph A.6.2.5).
     Such evidence may be from either limited evidence of
     carcinogenicity in human studies or from limited evidence of
     carcinogenicity in animal studies.
Other considerations: Where the weight of evidence for the
 carcinogenicity of a substance does not meet the above criteria, any
 positive study conducted in accordance with established scientific
 principles, and which reports statistically significant findings
 regarding the carcinogenic potential of the substance, must be noted on
 the safety data sheet.
------------------------------------------------------------------------

    A.6.2.2 Classification as a carcinogen is made on the basis of 
evidence from reliable and acceptable methods, and is intended to be 
used for substances which have an intrinsic property to produce such 
toxic effects. The evaluations are to be based on all existing data, 
peer-reviewed published studies and additional data accepted by 
regulatory agencies.
    A.6.2.3 Carcinogen classification is a one-step, criterion-based 
process that involves two interrelated determinations: evaluations 
of strength of evidence and consideration of all other relevant 
information to place substances with human cancer potential into 
hazard categories.
    A.6.2.4 Strength of evidence involves the enumeration of tumors 
in human and animal studies and determination of their level of 
statistical significance. Sufficient human evidence demonstrates 
causality between human exposure and the development of cancer, 
whereas sufficient evidence in animals shows a causal relationship 
between the agent and an increased incidence of tumors. Limited 
evidence in humans is demonstrated by a positive association between 
exposure and cancer, but a causal relationship cannot be stated. 
Limited evidence in animals is provided when data suggest a 
carcinogenic effect, but are less than sufficient. (Guidance on 
consideration of important factors in the classification of 
carcinogenicity and a more detailed description of the terms 
``limited'' and ``sufficient'' have been developed by the 
International Agency for Research on Cancer (IARC) and are provided 
in non-mandatory Appendix F).
    A.6.2.5 Weight of evidence: Beyond the determination of the 
strength of evidence for carcinogenicity, a number of other factors 
should be considered that influence the overall likelihood that an 
agent may pose a carcinogenic hazard in humans. The full list of 
factors that influence this determination is very lengthy, but some 
of the important ones are considered here.
    A.6.2.5.1 These factors can be viewed as either increasing or 
decreasing the level of concern for human carcinogenicity. The 
relative emphasis accorded to each factor depends upon the amount 
and coherence of evidence bearing on each. Generally there is a 
requirement for more complete information to decrease than to 
increase the level of concern. Additional considerations should be 
used in evaluating the tumor findings and the other factors in a 
case-by-case manner.
    A.6.2.5.2 Some important factors which may be taken into 
consideration, when assessing the overall level of concern are:
    (a) Tumor type and background incidence;
    (b) Multisite responses;
    (c) Progression of lesions to malignancy;
    (d) Reduced tumor latency;
    Additional factors which may increase or decrease the level of 
concern include:
    (e) Whether responses are in single or both sexes;
    (f) Whether responses are in a single species or several 
species;
    (g) Structural similarity or not to a substance(s) for which 
there is good evidence of carcinogenicity;
    (h) Routes of exposure;
    (i) Comparison of absorption, distribution, metabolism and 
excretion between test animals and humans;
    (j) The possibility of a confounding effect of excessive 
toxicity at test doses; and,
    (k) Mode of action and its relevance for humans, such as 
mutagenicity, cytotoxicity with growth stimulation, mitogenesis, 
immunosuppression.
    Mutagenicity: It is recognized that genetic events are central 
in the overall process of cancer development. Therefore evidence of 
mutagenic activity in vivo may indicate that a substance has a 
potential for carcinogenic effects.
    A.6.2.5.3 A substance that has not been tested for 
carcinogenicity may in certain instances be classified in Category 
1A, Category 1B, or Category 2 based on tumor data from a structural 
analogue together with substantial support from consideration of 
other important factors such as formation of common significant 
metabolites, e.g., for benzidine congener dyes.
    A.6.2.5.4 The classification should also take into consideration 
whether or not the substance is absorbed by a given route(s); or 
whether there are only local tumors at the site of administration 
for the tested route(s), and adequate testing by other major 
route(s) show lack of carcinogenicity.
    A.6.2.5.5 It is important that whatever is known of the physico-
chemical, toxicokinetic and toxicodynamic properties of the 
substances, as well as any available relevant information on 
chemical analogues, i.e., structure activity relationship, is taken 
into consideration when undertaking classification.

A.6.3 Classification Criteria for Mixtures 7
---------------------------------------------------------------------------

    \7\ It should be noted that the classification criteria for 
health hazards usually include a tiered scheme in which test data 
available on the complete mixture are considered as the first tier 
in the evaluation, followed by the applicable bridging principles, 
and lastly, cut-off values/concentration limit or additivity. 
However, this approach is not used for Carcinogenicity. These 
criteria for Carcinogenicity consider the cut-off values/
concentration limits as the primary tier and allow the 
classification to be modified only on a case-by-case evaluation 
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------

    A.6.3.1 The mixture shall be classified as a carcinogen when at 
least one ingredient has been classified as a Category 1 or Category 
2 carcinogen and is present at or above the appropriate cut-off 
value/concentration limit as shown in Table A.6.1.

Table A.6.1--Cut-Off Values/Concentration Limits of Ingredients of a Mixture Classified as Carcinogen That Would
                                      Trigger Classification of the Mixture
----------------------------------------------------------------------------------------------------------------
                                                    Category 1
           Ingredient classified as:                carcinogen                 Category 2  carcinogen
----------------------------------------------------------------------------------------------------------------
Category 1 carcinogen.........................              >=0.1%  ............................................
Category 2 carcinogen.........................  ..................  >=0.1% (note 1).
----------------------------------------------------------------------------------------------------------------
Note: If a Category 2 carcinogen ingredient is present in the mixture at a concentration between 0.1% and 1%,
  information is required on the SDS for a product. However, a label warning is optional. If a Category 2
  carcinogen ingredient is present in the mixture at a concentration of =1%, both an SDS and a label
  is required and the information must be included on each.


[[Page 17808]]

A.6.3.2 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    A mixture may be classified based on the available test data for 
the mixture as a whole. In such cases, the test results for the 
mixture as a whole must be shown to be conclusive taking into 
account dose and other factors such as duration, observations and 
analysis (e.g., statistical analysis, test sensitivity) of 
carcinogenicity test systems.

A.6.3.3 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    Where the mixture itself has not been tested to determine its 
carcinogenic hazard, but there are sufficient data on both the 
individual ingredients and similar tested mixtures to adequately 
characterize the hazards of the mixture, these data will be used in 
accordance with the following bridging principles as found in 
paragraph A.0.5 of this Appendix: Dilution; Batching; and 
Substantially similar mixtures.

A.6.4 Classification of Carcinogenicity 8
---------------------------------------------------------------------------

    \8\ See Non-mandatory Appendix F for further guidance regarding 
hazard classification for carcinogenicity and how to relate 
carcinogenicity classification information from IARC and NTP to GHS.
---------------------------------------------------------------------------

    A.6.4.1 Chemical manufacturers, importers and employers 
evaluating chemicals may treat the following sources as establishing 
that a substance is a carcinogen or potential carcinogen for hazard 
communication purposes in lieu of applying the criteria described 
herein:
    A.6.4.1.1 National Toxicology Program (NTP), ``Report on 
Carcinogens'' (latest edition);
    A.6.4.1.2 International Agency for Research on Cancer (IARC) 
``Monographs on the Evaluation of Carcinogenic Risks to Humans'' 
(latest editions)
    A.6.4.2 Where OSHA has included cancer as a health hazard to be 
considered by classifiers for a chemical covered by 29 CFR part 
1910, Subpart Z, Toxic and Hazardous Substances, chemical 
manufacturers, importers, and employers shall classify the chemical 
as a carcinogen.

A.7 REPRODUCTIVE TOXICITY

A.7.1 Definitions and General Considerations

    A.7.1.1 Reproductive toxicity 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 or via lactation shall be classified in a separate hazard 
category in accordance with Figure A.7.1(b).

      Figure A.7.1(a)--Hazard Categories for Reproductive Toxicants
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Known or presumed human reproductive toxicant.
    Substance shall be classified in Category 1 for reproductive
     toxicity when they are known to have produced an adverse effect on
     sexual function and fertility or on development in humans or when
     there is evidence from animal studies, possibly supplemented with
     other information, to provide a strong presumption that the
     substance has the capacity to interfere with reproduction in
     humans. The classification of a substance is further distinguished
     on the basis of whether the evidence for classification is
     primarily from human data (Category 1A) or from animal data
     (Category 1B).
Category 1A: Known human reproductive toxicant.
    The classification of a substance in this category is largely based
     on evidence from humans.
Category 1B: Presumed human reproductive toxicant.
    The classification of a substance in this category is largely based
     on evidence from experimental animals. Data from animal studies
     shall provide sufficient evidence of an adverse effect on sexual
     function and fertility or on development in the absence of other
     toxic effects, or if occurring together with other toxic effects
     the adverse effect on reproduction is considered not to be a
     secondary non-specific consequence of other toxic effects. However,
     when there is mechanistic information that raises doubt about the
     relevance of the effect for humans, classification in Category 2
     may be more appropriate.
CATEGORY 2: Suspected human reproductive toxicant.
    Substances shall be classified in Category 2 for reproductive
     toxicity when there is some evidence from humans or experimental
     animals, possibly supplemented with other information, of an
     adverse effect on sexual function and fertility, or on development,
     in the absence of other toxic effects, or if occurring together
     with other toxic effects the adverse effect on reproduction is
     considered not to be a secondary non-specific consequence of the
     other toxic effects, and where the evidence is not sufficiently
     convincing to place the substance in Category 1. For instance,
     deficiencies in the study may make the quality of evidence less
     convincing, and in view of this, Category 2 would be the more
     appropriate classification.
------------------------------------------------------------------------


    Figure A.7.1(b)--Hazard Category for Effects on or Via Lactation
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
EFFECTS ON OR VIA LACTATION
Effects on or via lactation shall be classified in a separate single
 category. Chemicals that are absorbed by women and have been shown to
 interfere with lactation or that may be present (including metabolites)
 in breast milk in amounts sufficient to cause concern for the health of
 a breastfed child, shall be classified to indicate this property
 hazardous to breastfed babies. This classification shall be assigned on
 the basis of:
    (a) absorption, metabolism, distribution and excretion studies that
     indicate the likelihood the substance would be present in
     potentially toxic levels in breast milk; and/or

[[Page 17809]]

 
    (b) results of one or two generation studies in animals which
     provide clear evidence of adverse effect in the offspring due to
     transfer in the milk or adverse effect on the quality of the milk;
     and/or
    (c) human evidence indicating a hazard to babies during the
     lactation period.
------------------------------------------------------------------------

A.7.2.2 Basis of Classification

    A.7.2.2.1 Classification is made on the basis of the criteria, 
outlined above, an assessment of the total weight of evidence, and 
the use of expert judgment. Classification as a reproductive 
toxicant is intended to be used for substances which have an 
intrinsic, specific property to produce an adverse effect on 
reproduction and substances should not be so classified if such an 
effect is produced solely as a non-specific secondary consequence of 
other toxic effects.
    A.7.2.2.2 In the evaluation of toxic effects on the developing 
offspring, it is important to consider the possible influence of 
maternal toxicity.
    A.7.2.2.3 For human evidence to provide the primary basis for a 
Category 1A classification there must be reliable evidence of an 
adverse effect on reproduction in humans. Evidence used for 
classification shall be from well conducted epidemiological studies, 
if available, which include the use of appropriate controls, 
balanced assessment, and due consideration of bias or confounding 
factors. Less rigorous data from studies in humans may be sufficient 
for a Category 1A classification if supplemented with adequate data 
from studies in experimental animals, but classification in Category 
1B may also be considered.

A.7.2.3 Weight of Evidence

    A.7.2.3.1 Classification as a reproductive toxicant is made on 
the basis of an assessment of the total weight of evidence using 
expert judgment. This means that all available information that 
bears on the determination of reproductive toxicity is considered 
together. Included is information such as epidemiological studies 
and case reports in humans and specific reproduction studies along 
with sub-chronic, chronic and special study results in animals that 
provide relevant information regarding toxicity to reproductive and 
related endocrine organs. Evaluation of substances chemically 
related to the material under study may also be included, 
particularly when information on the material is scarce. The weight 
given to the available evidence will be influenced by factors such 
as the quality of the studies, consistency of results, nature and 
severity of effects, level of statistical significance for 
intergroup differences, number of endpoints affected, relevance of 
route of administration to humans and freedom from bias. Both 
positive and negative results are considered together in a weight of 
evidence determination. However, a single, positive study performed 
according to good scientific principles and with statistically or 
biologically significant positive results may justify classification 
(See also A.7.2.2.3).
    A.7.2.3.2 Toxicokinetic studies in animals and humans, site of 
action and mechanism or mode of action study results may provide 
relevant information, which could reduce or increase concerns about 
the hazard to human health. If it is conclusively demonstrated that 
the clearly identified mechanism or mode of action has no relevance 
for humans or when the toxicokinetic differences are so marked that 
it is certain that the hazardous property will not be expressed in 
humans then a chemical which produces an adverse effect on 
reproduction in experimental animals should not be classified.
    A.7.2.3.3 In some reproductive toxicity studies in experimental 
animals the only effects recorded may be considered of low or 
minimal toxicological significance and classification may not 
necessarily be the outcome. These effects include, for example, 
small changes in semen parameters or in the incidence of spontaneous 
defects in the fetus, small changes in the proportions of common 
fetal variants such as are observed in skeletal examinations, or in 
fetal weights, or small differences in postnatal developmental 
assessments.
    A.7.2.3.4 Data from animal studies shall provide sufficient 
evidence of specific reproductive toxicity in the absence of other 
systemic toxic effects. However, if developmental toxicity occurs 
together with other toxic effects in the dam (mother), the potential 
influence of the generalized adverse effects should be assessed to 
the extent possible. The preferred approach is to consider adverse 
effects in the embryo/fetus first, and then evaluate maternal 
toxicity, along with any other factors which are likely to have 
influenced these effects, as part of the weight of evidence. In 
general, developmental effects that are observed at maternally toxic 
doses should not be automatically discounted. Discounting 
developmental effects that are observed at maternally toxic doses 
can only be done on a case-by-case basis when a causal relationship 
is established or refuted.
    A.7.2.3.5 If appropriate information is available it is 
important to try to determine whether developmental toxicity is due 
to a specific maternally mediated mechanism or to a non-specific 
secondary mechanism, like maternal stress and the disruption of 
homeostasis. Generally, the presence of maternal toxicity should not 
be used to negate findings of embryo/fetal effects, unless it can be 
clearly demonstrated that the effects are secondary non-specific 
effects. This is especially the case when the effects in the 
offspring are significant, e.g., irreversible effects such as 
structural malformations. In some situations it is reasonable to 
assume that reproductive toxicity is due to a secondary consequence 
of maternal toxicity and discount the effects, for example if the 
chemical is so toxic that dams fail to thrive and there is severe 
inanition; they are incapable of nursing pups; or they are prostrate 
or dying.

A.7.2.4 Maternal Toxicity

    A.7.2.4.1 Development of the offspring throughout gestation and 
during the early postnatal stages can be influenced by toxic effects 
in the mother either through non-specific mechanisms related to 
stress and the disruption of maternal homeostasis, or by specific 
maternally-mediated mechanisms. So, in the interpretation of the 
developmental outcome to decide classification for developmental 
effects it is important to consider the possible influence of 
maternal toxicity. This is a complex issue because of uncertainties 
surrounding the relationship between maternal toxicity and 
developmental outcome. Expert judgment and a weight of evidence 
approach, using all available studies, shall be used to determine 
the degree of influence to be attributed to maternal toxicity when 
interpreting the criteria for classification for developmental 
effects. The adverse effects in the embryo/fetus shall be first 
considered, and then maternal toxicity, along with any other factors 
which are likely to have influenced these effects, as weight of 
evidence, to help reach a conclusion about classification.
    A.7.2.4.2 Based on pragmatic observation, it is believed that 
maternal toxicity may, depending on severity, influence development 
via non-specific secondary mechanisms, producing effects such as 
depressed fetal weight, retarded ossification, and possibly 
resorptions and certain malformations in some strains of certain 
species. However, the limited numbers of studies which have 
investigated the relationship between developmental effects and 
general maternal toxicity have failed to demonstrate a consistent, 
reproducible relationship across species. Developmental effects 
which occur even in the presence of maternal toxicity are considered 
to be evidence of developmental toxicity, unless it can be 
unequivocally demonstrated on a case by case basis that the 
developmental effects are secondary to maternal toxicity. Moreover, 
classification shall be considered where there is a significant 
toxic effect in the offspring, e.g., irreversible effects such as 
structural malformations, embryo/fetal lethality, or significant 
post-natal functional deficiencies.
    A.7.2.4.3 Classification shall not automatically be discounted 
for chemicals that produce developmental toxicity only in 
association with maternal toxicity, even if a specific maternally-
mediated mechanism has been demonstrated. In such a case, 
classification in Category 2 may be considered more appropriate than 
Category 1. However, when a chemical is so toxic that maternal death 
or severe inanition results, or the dams (mothers) are prostrate and 
incapable of nursing the pups, it is reasonable to assume that 
developmental toxicity is produced solely as a secondary consequence 
of maternal toxicity and discount the developmental effects.

[[Page 17810]]

Classification is not necessarily the outcome in the case of minor 
developmental changes, e.g., a small reduction in fetal/pup body 
weight or retardation of ossification when seen in association with 
maternal toxicity.
    A.7.2.4.4 Some of the endpoints used to assess maternal toxicity 
are provided below. Data on these endpoints, if available, shall be 
evaluated in light of their statistical or biological significance 
and dose-response relationship.
    (a) Maternal mortality: An increased incidence of mortality 
among the treated dams over the controls shall be considered 
evidence of maternal toxicity if the increase occurs in a dose-
related manner and can be attributed to the systemic toxicity of the 
test material. Maternal mortality greater than 10% is considered 
excessive and the data for that dose level shall not normally be 
considered to need further evaluation.
    (b) Mating index (Number of animals with seminal plugs or sperm/
Number of mated x 100)
    (c) Fertility index (Number of animals with implants/Number of 
matings x 100)
    (d) Gestation length (If allowed to deliver)
    (e) Body weight and body weight change: Consideration of the 
maternal body weight change and/or adjusted (corrected) maternal 
body weight shall be included in the evaluation of maternal toxicity 
whenever such data are available. The calculation of an adjusted 
(corrected) mean maternal body weight change, which is the 
difference between the initial and terminal body weight minus the 
gravid uterine weight (or alternatively, the sum of the weights of 
the fetuses), may indicate whether the effect is maternal or 
intrauterine. In rabbits, the body weight gain may not be a useful 
indicator of maternal toxicity because of normal fluctuations in 
body weight during pregnancy.
    (f) Food and water consumption (if relevant): The observation of 
a significant decrease in the average food or water consumption in 
treated dams (mothers) compared to the control group may be useful 
in evaluating maternal toxicity, particularly when the test material 
is administered in the diet or drinking water. Changes in food or 
water consumption must be evaluated in conjunction with maternal 
body weights when determining if the effects noted are reflective of 
maternal toxicity or more simply, unpalatability of the test 
material in feed or water.
    (g) Clinical evaluations (including clinical signs, markers, and 
hematology and clinical chemistry studies): The observation of 
increased incidence of significant clinical signs of toxicity in 
treated dams (mothers) relative to the control group is useful in 
evaluating maternal toxicity. If this is to be used as the basis for 
the assessment of maternal toxicity, the types, incidence, degree 
and duration of clinical signs shall be reported in the study. 
Clinical signs of maternal intoxication include, but are not limited 
to: coma, prostration, hyperactivity, loss of righting reflex, 
ataxia, or labored breathing.
    (h) Post-mortem data: Increased incidence and/or severity of 
post-mortem findings may be indicative of maternal toxicity. This 
can include gross or microscopic pathological findings or organ 
weight data, including absolute organ weight, organ-to-body weight 
ratio, or organ-to-brain weight ratio. When supported by findings of 
adverse histopathological effects in the affected organ(s), the 
observation of a significant change in the average weight of 
suspected target organ(s) of treated dams (mothers), compared to 
those in the control group, may be considered evidence of maternal 
toxicity.

A.7.2.5 Animal and Experimental Data

    A.7.2.5.1 A number of scientifically validated test methods are 
available, including methods for developmental toxicity testing 
(e.g., OECD Test Guideline 414, ICH Guideline S5A, 1993), methods 
for peri- and post-natal toxicity testing (e.g., ICH S5B, 1995), and 
methods for one or two-generation toxicity testing (e.g., OECD Test 
Guidelines 415, 416)
    A.7.2.5.2 Results obtained from screening tests (e.g., OECD 
Guidelines 421--Reproduction/Developmental Toxicity Screening Test, 
and 422--Combined Repeated Dose Toxicity Study with Reproduction/
Development Toxicity Screening Test) can also be used to justify 
classification, although the quality of this evidence is less 
reliable than that obtained through full studies.
    A.7.2.5.3 Adverse effects or changes, seen in short- or long-
term repeated dose toxicity studies, which are judged likely to 
impair reproductive function and which occur in the absence of 
significant generalized toxicity, may be used as a basis for 
classification, e.g., histopathological changes in the gonads.
    A.7.2.5.4 Evidence from in vitro assays, or non-mammalian tests, 
and from analogous substances using structure-activity relationship 
(SAR), can contribute to the procedure for classification. In all 
cases of this nature, expert judgment must be used to assess the 
adequacy of the data. Inadequate data shall not be used as a primary 
support for classification.
    A.7.2.5.5 It is preferable that animal studies are conducted 
using appropriate routes of administration which relate to the 
potential route of human exposure. However, in practice, 
reproductive toxicity studies are commonly conducted using the oral 
route, and such studies will normally be suitable for evaluating the 
hazardous properties of the substance with respect to reproductive 
toxicity. However, if it can be conclusively demonstrated that the 
clearly identified mechanism or mode of action has no relevance for 
humans or when the toxicokinetic differences are so marked that it 
is certain that the hazardous property will not be expressed in 
humans then a substance which produces an adverse effect on 
reproduction in experimental animals should not be classified.
    A.7.2.5.6 Studies involving routes of administration such as 
intravenous or intraperitoneal injection, which may result in 
exposure of the reproductive organs to unrealistically high levels 
of the test substance, or elicit local damage to the reproductive 
organs, e.g., by irritation, must be interpreted with extreme 
caution and on their own are not normally the basis for 
classification.
    A.7.2.5.7 There is general agreement about the concept of a 
limit dose, above which the production of an adverse effect may be 
considered to be outside the criteria which lead to classification. 
Some test guidelines specify a limit dose, other test guidelines 
qualify the limit dose with a statement that higher doses may be 
necessary if anticipated human exposure is sufficiently high that an 
adequate margin of exposure would not be achieved. Also, due to 
species differences in toxicokinetics, establishing a specific limit 
dose may not be adequate for situations where humans are more 
sensitive than the animal model.
    A.7.2.5.8 In principle, adverse effects on reproduction seen 
only at very high dose levels in animal studies (for example doses 
that induce prostration, severe inappetence, excessive mortality) do 
not normally lead to classification, unless other information is 
available, for example, toxicokinetics information indicating that 
humans may be more susceptible than animals, to suggest that 
classification is appropriate.
    A.7.2.5.9 However, specification of the actual ``limit dose'' 
will depend upon the test method that has been employed to provide 
the test results.

A.7.3 Classification Criteria for Mixtures 9
---------------------------------------------------------------------------

    \9\ It should be noted that the classification criteria for 
health hazards usually include a tiered scheme in which test data 
available on the complete mixture are considered as the first tier 
in the evaluation, followed by the applicable bridging principles, 
and lastly, cut-off values/concentration limits or additivity. 
However, this approach is not used for Reproductive Toxicity. These 
criteria for Reproductive Toxicity consider the cut-off values/
concentration limits as the primary tier and allow the 
classification to be modified only on a case-by-case evaluation 
based on available test data for the mixture as a whole.
---------------------------------------------------------------------------

A.7.3.1 Classification of Mixtures When Data Are Available for All 
Ingredients or Only for Some Ingredients of the Mixture

    A.7.3.1.1 The mixture shall be classified as a reproductive 
toxicant when at least one ingredient has been classified as a 
Category 1 or Category 2 reproductive toxicant and is present at or 
above the appropriate cut-off value/concentration limit specified in 
Table A.7.1 for Category 1 and 2, respectively.
    A.7.3.1.2 The mixture shall be classified for effects on or via 
lactation when at least one ingredient has been classified for 
effects on or via lactation and is present at or above the 
appropriate cut-off value/concentration limit specified in Table 
A.7.1 for the additional category for effects on or via lactation.

[[Page 17811]]



     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:                                                           Additional category for
                                     Category 1 reproductive   Category 2 reproductive      effects on or via
                                            toxicant                  toxicant                  lactation
----------------------------------------------------------------------------------------------------------------
Category 1 reproductive toxicant..                    >=0.1%  ........................  ........................
Category 2 reproductive toxicant..  ........................                    >=0.1%  ........................
Additional category for effects on  ........................  ........................                    >=0.1%
 or via lactation.................
----------------------------------------------------------------------------------------------------------------

A.7.3.2 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    Available test data for the mixture as a whole may be used for 
classification on a case-by-case basis. In such cases, the test 
results for the mixture as a whole must be shown to be conclusive 
taking into account dose and other factors such as duration, 
observations and analysis (e.g., statistical analysis, test 
sensitivity) of reproduction test systems.

A.7.3.3 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.7.3.3.1 Where the mixture itself has not been tested to 
determine its reproductive toxicity, but there are sufficient data 
on both the individual ingredients and similar tested mixtures to 
adequately characterize the hazards of the mixture, these data shall 
be used in accordance with the following bridging principles as 
found in paragraph A.0.5 of this Appendix: Dilution, Batching, and 
Substantially similar mixtures.

A.8 SPECIFIC TARGET ORGAN TOXICITY SINGLE EXPOSURE

A.8.1 Definitions and General Considerations

    A.8.1.1 Specific target organ toxicity--single exposure, (STOT-
SE) 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.

   Figure A.8.1--Hazard Categories for Specific Target Organ Toxicity
                        Following Single Exposure
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Substances that have produced significant toxicity in
 humans, or that, on the basis of evidence from studies in experimental
 animals can be presumed to have the potential to produce significant
 toxicity in humans following single exposure
Substances are classified in Category 1 for STOT-SE on the basis of:
(a) reliable and good quality evidence from human cases or
 epidemiological studies; or
(b) observations from appropriate studies in experimental animals in
 which significant and/or severe toxic effects of relevance to human
 health were produced at generally low exposure concentrations. Guidance
 dose/concentration values are provided below (See A.8.2.1.9) to be used
 as part of weight-of-evidence evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in
 experimental animals, can be presumed to have the potential to be
 harmful to human health following single exposure
Substances are classified in Category 2 for STOT-SE on the basis of
 observations from appropriate studies in experimental animals in which
 significant toxic effects, of relevance to human health, were produced
 at generally moderate exposure concentrations. Guidance dose/
 concentration values are provided below (See A.8.2.1.9) in order to
 help in classification.
In exceptional cases, human evidence can also be used to place a
 substance in Category 2 (See A.8.2.1.6).
CATEGORY 3: Transient target organ effects
There are target organ effects for which a substance does not meet the
 criteria to be classified in Categories 1 or 2 indicated above. These
 are effects which adversely alter human function for a short duration
 after exposure and from which humans may recover in a reasonable period
 without leaving significant alteration of structure or function. This
 category only includes narcotic effects and respiratory tract
 irritation. Substances are classified specifically for these effects as
 discussed in A.8.2.2.
Note: The primary target organ/system shall be identified where
 possible, and where this is not possible, the substance shall be
 identified as a general toxicant. The data shall be evaluated and,
 where possible, shall not include secondary effects (e.g., a
 hepatotoxicant can produce secondary effects in the nervous or gastro-
 intestinal systems).
------------------------------------------------------------------------

    A.8.2.1.2 The relevant route(s) of exposure by which the 
classified substance produces damage shall be identified.
    A.8.2.1.3 Classification is determined by expert judgment, on 
the basis of the weight of all evidence available including the 
guidance presented below.

[[Page 17812]]

    A.8.2.1.4 Weight of evidence of all available data, including 
human incidents, epidemiology, and studies conducted in experimental 
animals is used to substantiate specific target organ toxic effects 
that merit classification.
    A.8.2.1.5 The information required to evaluate specific target 
organ toxicity comes either from single exposure in humans (e.g., 
exposure at home, in the workplace or environmentally), or from 
studies conducted in experimental animals. The standard animal 
studies in rats or mice that provide this information are acute 
toxicity studies which can include clinical observations and 
detailed macroscopic and microscopic examination to enable the toxic 
effects on target tissues/organs to be identified. Results of acute 
toxicity studies conducted in other species may also provide 
relevant information.
    A.8.2.1.6 In exceptional cases, based on expert judgment, it may 
be appropriate to place certain substances with human evidence of 
target organ toxicity in Category 2: (a) when the weight of human 
evidence is not sufficiently convincing to warrant Category 1 
classification, and/or (b) based on the nature and severity of 
effects. Dose/concentration levels in humans shall not be considered 
in the classification and any available evidence from animal studies 
shall be consistent with the Category 2 classification. In other 
words, if there are also animal data available on the substance that 
warrant Category 1 classification, the chemical shall be classified 
as Category 1.
    A.8.2.1.7 Effects considered to support classification for 
Category 1 and 2
    A.8.2.1.7.1 Classification is supported by evidence associating 
single exposure to the substance with a consistent and identifiable 
toxic effect.
    A.8.2.1.7.2 Evidence from human experience/incidents is usually 
restricted to reports of adverse health consequences, often with 
uncertainty about exposure conditions, and may not provide the 
scientific detail that can be obtained from well-conducted studies 
in experimental animals.
    A.8.2.1.7.3 Evidence from appropriate studies in experimental 
animals can furnish much more detail, in the form of clinical 
observations, and macroscopic and microscopic pathological 
examination and this can often reveal hazards that may not be life-
threatening but could indicate functional impairment. Consequently 
all available evidence, and evidence relevance to human health, must 
be taken into consideration in the classification process. Relevant 
toxic effects in humans and/or animals include, but are not limited 
to:
    (a) Morbidity resulting from single exposure;
    (b) Significant functional changes, more than transient in 
nature, in the respiratory system, central or peripheral nervous 
systems, other organs or other organ systems, including signs of 
central nervous system depression and effects on special senses 
(e.g., sight, hearing and sense of smell);
    (c) Any consistent and significant adverse change in clinical 
biochemistry, hematology, or urinalysis parameters;
    (d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;
    (e) Multi-focal or diffuse necrosis, fibrosis or granuloma 
formation in vital organs with regenerative capacity;
    (f) Morphological changes that are potentially reversible but 
provide clear evidence of marked organ dysfunction; and,
    (g) Evidence of appreciable cell death (including cell 
degeneration and reduced cell number) in vital organs incapable of 
regeneration.
    A.8.2.1.8 Effects considered not to support classification for 
Category 1 and 2
    Effects may be seen in humans and/or animals that do not justify 
classification. Such effects include, but are not limited to:
    (a) Clinical observations or small changes in bodyweight gain, 
food consumption or water intake that may have some toxicological 
importance but that do not, by themselves, indicate ``significant'' 
toxicity;
    (b) Small changes in clinical biochemistry, hematology or 
urinalysis parameters and/or transient effects, when such changes or 
effects are of doubtful or of minimal toxicological importance;
    (c) Changes in organ weights with no evidence of organ 
dysfunction;
    (d) Adaptive responses that are not considered toxicologically 
relevant; and,
    (e) Substance-induced species-specific mechanisms of toxicity, 
i.e., demonstrated with reasonable certainty to be not relevant for 
human health, shall not justify classification.
    A.8.2.1.9 Guidance values to assist with classification based on 
the results obtained from studies conducted in experimental animals 
for Category 1 and 2
    A.8.2.1.9.1 In order to help reach a decision about whether a 
substance shall be classified or not, and to what degree it shall be 
classified (Category 1 vs. Category 2), dose/concentration 
``guidance values'' are provided for consideration of the dose/
concentration which has been shown to produce significant health 
effects. The principal argument for proposing such guidance values 
is that all chemicals are potentially toxic and there has to be a 
reasonable dose/concentration above which a degree of toxic effect 
is acknowledged.
    A.8.2.1.9.2 Thus, in animal studies, when significant toxic 
effects are observed that indicate classification, consideration of 
the dose/concentration at which these effects were seen, in relation 
to the suggested guidance values, provides useful information to 
help assess the need to classify (since the toxic effects are a 
consequence of the hazardous property(ies) and also the dose/
concentration).
    A.8.2.1.9.3 The guidance value (C) ranges for single-dose 
exposure which has produced a significant non-lethal toxic effect 
are those applicable to acute toxicity testing, as indicated in 
Table A.8.1.

                          Table A.8.1--Guidance Value Ranges for Single-Dose Exposures
----------------------------------------------------------------------------------------------------------------
                                                                      Guidance value ranges for:
        Route of exposure                Units       -----------------------------------------------------------
                                                          Category 1          Category 2          Category 3
----------------------------------------------------------------------------------------------------------------
Oral (rat)......................  mg/kg body weight.  C <=300...........  2000 >=C >300.....  Guidance values do
                                                                                               not apply.
Dermal (rat or rabbit)..........  mg/kg body weight.  C <=1,000.........  2000 >=C >1,000...
Inhalation (rat) gas............  ppmV/4h...........  C <=2,500.........  20,000 >=C >2,500.
Inhalation (rat) vapor..........  mg/1/4h...........  C <=10............  20 >=C >10........
Inhalation (rat) dust/mist/fume.  mg/l/4h...........  C <=1.0...........  5.0 >=C >1.0......
----------------------------------------------------------------------------------------------------------------

    A.8.2.1.9.4 The guidance values and ranges mentioned in Table 
A.8.1 are intended only for guidance purposes, i.e., to be used as 
part of the weight of evidence approach, and to assist with 
decisions about classification. They are not intended as strict 
demarcation values. Guidance values are not provided for Category 3 
since this classification is primarily based on human data; animal 
data may be included in the weight of evidence evaluation.
    A.8.2.1.9.5 Thus, it is feasible that a specific profile of 
toxicity occurs at a dose/concentration below the guidance value, 
e.g., <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 the classification process includes reference to dose/
concentration guidance values as one of

[[Page 17813]]

the elements that contribute to the weight of evidence approach.
    A.8.2.1.10.2 When well-substantiated human data are available 
showing a specific target organ toxic effect that can be reliably 
attributed to single exposure to a substance, the substance shall be 
classified. Positive human data, regardless of probable dose, 
predominates over animal data. Thus, if a substance is unclassified 
because specific target organ toxicity observed was considered not 
relevant or significant to humans, if subsequent human incident data 
become available showing a specific target organ toxic effect, the 
substance shall be classified.
    A.8.2.1.10.3 A substance that has not been tested for specific 
target organ toxicity shall, where appropriate, be classified on the 
basis of data from a scientifically validated structure activity 
relationship and expert judgment-based extrapolation from a 
structural analogue that has previously been classified together 
with substantial support from consideration of other important 
factors such as formation of common significant metabolites.

A.8.2.2 Substances of Category 3

    A.8.2.2.1 Criteria for respiratory tract irritation
    The criteria for classifying substances as Category 3 for 
respiratory tract irritation are:
    (a) Respiratory irritant effects (characterized by localized 
redness, edema, pruritis and/or pain) that impair function with 
symptoms such as cough, pain, choking, and breathing difficulties 
are included. It is recognized that this evaluation is based 
primarily on human data;
    (b) Subjective human observations supported by objective 
measurements of clear respiratory tract irritation (RTI) (e.g., 
electrophysiological responses, biomarkers of inflammation in nasal 
or bronchoalveolar lavage fluids);
    (c) The symptoms observed in humans shall also be typical of 
those that would be produced in the exposed population rather than 
being an isolated idiosyncratic reaction or response triggered only 
in individuals with hypersensitive airways. Ambiguous reports simply 
of ``irritation'' should be excluded as this term is commonly used 
to describe a wide range of sensations including those such as 
smell, unpleasant taste, a tickling sensation, and dryness, which 
are outside the scope of classification for respiratory tract 
irritation;
    (d) There are currently no scientifically validated animal tests 
that deal specifically with RTI; however, useful information may be 
obtained from the single and repeated inhalation toxicity tests. For 
example, animal studies may provide useful information in terms of 
clinical signs of toxicity (dyspnoea, rhinitis etc) and 
histopathology (e.g., hyperemia, edema, minimal inflammation, 
thickened mucous layer) which are reversible and may be reflective 
of the characteristic clinical symptoms described above. Such animal 
studies can be used as part of weight of evidence evaluation; and,
    (e) This special classification will occur only when more severe 
organ effects including the respiratory system are not observed as 
those effects would require a higher classification.
    A.8.2.2.2 Criteria for narcotic effects
    The criteria for classifying substances in Category 3 for 
narcotic effects are:
    (a) Central nervous system depression including narcotic effects 
in humans such as drowsiness, narcosis, reduced alertness, loss of 
reflexes, lack of coordination, and vertigo are included. These 
effects can also be manifested as severe headache or nausea, and can 
lead to reduced judgment, dizziness, irritability, fatigue, impaired 
memory function, deficits in perception and coordination, reaction 
time, or sleepiness; and,
    (b) Narcotic effects observed in animal studies may include 
lethargy, lack of coordination righting reflex, narcosis, and 
ataxia. If these effects are not transient in nature, then they 
shall be considered for classification as Category 1 or 2.

A.8.3 Classification Criteria for Mixtures

    A.8.3.1 Mixtures are classified using the same criteria as for 
substances, or alternatively as described below. As with substances, 
mixtures may be classified for specific target organ toxicity 
following single exposure, repeated exposure, or both.

A.8.3.2 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    When reliable and good quality evidence from human experience or 
appropriate studies in experimental animals, as described in the 
criteria for substances, is available for the mixture, then the 
mixture shall be classified by weight of evidence evaluation of this 
data. Care shall be exercised in evaluating data on mixtures, that 
the dose, duration, observation or analysis, do not render the 
results inconclusive.

A.8.3.3 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.8.3.3.1 Where the mixture itself has not been tested to 
determine its specific target organ toxicity, but there are 
sufficient data on both the individual ingredients and similar 
tested mixtures to adequately characterize the hazards of the 
mixture, these data shall be used in accordance with the following 
bridging principles as found in paragraph A.0.5 of this Appendix: 
Dilution, Batching, Concentration of mixtures, Interpolation within 
one 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.

  Table A.8.2--Cut-Off Values/Concentration Limits of Ingredients of a
    Mixture Classified as a Specific Target Organ Toxicant That Would
        Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
                                           Cut-off values/concentration
                                                 limits triggering
                                            classification of a mixture
        Ingredient classified as:                       as:
                                         -------------------------------
                                            Category 1      Category 2
------------------------------------------------------------------------
Category 1 Target organ toxicant........          >=1.0%  ..............
Category 2 Target organ toxicant........  ..............          >=1.0%
------------------------------------------------------------------------

    A.8.3.4.2 These cut-off values and consequent classifications 
shall be applied equally and appropriately to both single- and 
repeated-dose target organ toxicants.
    A.8.3.4.3 Mixtures shall be classified for either or both single 
and repeated dose toxicity independently.
    A.8.3.4.4 Care shall be exercised when toxicants affecting more 
than one organ system are combined that the potentiation or 
synergistic interactions are considered, because certain substances 
can cause target organ toxicity at <1% concentration when other 
ingredients in the mixture are known to potentiate its toxic effect.
    A.8.3.4.5 Care shall be exercised when extrapolating the 
toxicity of a mixture that contains Category 3 ingredient(s). A cut-
off value/concentration limit of 20%, considered as an additive of 
all Category 3 ingredients for each hazard endpoint, is appropriate; 
however, this cut-off value/concentration limit may be higher or 
lower depending on the Category 3 ingredient(s) involved and the 
fact that some effects such as respiratory tract irritation may not 
occur below a certain concentration while other effects such as 
narcotic effects may occur below this 20% value. Expert judgment 
shall be exercised. Respiratory tract irritation and narcotic

[[Page 17814]]

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, e.g., principally oral, dermal or 
inhalation.

A.9.2 Classification Criteria for Substances

    A.9.2.1 Substances shall be classified as STOT-RE by expert 
judgment on the basis of the weight of all evidence available, 
including the use of recommended guidance values which take into 
account the duration of exposure and the dose/concentration which 
produced the effect(s), (See A.9.2.9). Substances shall be placed in 
one of two categories, depending upon the nature and severity of the 
effect(s) observed, in accordance with Figure A.9.1.

   Figure A.9.1--Hazard Categories for Specific Target Organ Toxicity
                       Following Repeated Exposure
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
CATEGORY 1: Substances that have produced significant toxicity in
 humans, or that, on the basis of evidence from studies in experimental
 animals can be presumed to have the potential to produce significant
 toxicity in humans following repeated or prolonged exposure
    Substances are classified in Category 1 for specific target organ
     toxicity (repeated exposure) on the basis of:
    (a) reliable and good quality evidence from human cases or
     epidemiological studies; or,
    (b) observations from appropriate studies in experimental animals in
     which significant and/or severe toxic effects, of relevance to
     human health, were produced at generally low exposure
     concentrations. Guidance dose/concentration values are provided
     below (See A.9.2.9) to be used as part of weight-of-evidence
     evaluation.
CATEGORY 2: Substances that, on the basis of evidence from studies in
 experimental animals can be presumed to have the potential to be
 harmful to human health following repeated or prolonged exposure
    Substances are classified in Category 2 for specific target organ
     toxicity (repeated exposure) on the basis of observations from
     appropriate studies in experimental animals in which significant
     toxic effects, of relevance to human health, were produced at
     generally moderate exposure concentrations. Guidance dose/
     concentration values are provided below (See A.9.2.9) in order to
     help in classification.
    In exceptional cases human evidence can also be used to place a
     substance in Category 2 (See A.9.2.6).
Note: The primary target organ/system shall be identified where
 possible, or the substance shall be identified as a general toxicant.
 The data shall be carefully evaluated and, where possible, shall not
 include secondary effects (e.g., a hepatotoxicant can produce secondary
 effects in the nervous or gastro-intestinal systems).
------------------------------------------------------------------------

    A.9.2.2 The relevant route of exposure by which the classified 
substance produces damage shall be identified.
    A.9.2.3 Classification is determined by expert judgment, on the 
basis of the weight of all evidence available including the guidance 
presented below.
    A.9.2.4 Weight of evidence of all data, including human 
incidents, epidemiology, and studies conducted in experimental 
animals, is used to substantiate specific target organ toxic effects 
that merit classification.
    A.9.2.5 The information required to evaluate specific target 
organ toxicity comes either from repeated exposure in humans, e.g., 
exposure at home, in the workplace or environmentally, or from 
studies conducted in experimental animals. The standard animal 
studies in rats or mice that provide this information are 28 day, 90 
day or lifetime studies (up to 2 years) that include hematological, 
clinico-chemical and detailed macroscopic and microscopic 
examination to enable the toxic effects on target tissues/organs to 
be identified. Data from repeat dose studies performed in other 
species may also be used. Other long-term exposure studies, e.g., 
for carcinogenicity, neurotoxicity or reproductive toxicity, may 
also provide evidence of specific target organ toxicity that could 
be used in the assessment of classification.
    A.9.2.6 In exceptional cases, based on expert judgment, it may 
be appropriate to place certain substances with human evidence of 
specific target organ toxicity in Category 2: (a) when the weight of 
human evidence is not sufficiently convincing to warrant Category 1 
classification, and/or (b) based on the nature and severity of 
effects. Dose/concentration levels in humans shall not be considered 
in the classification and any available evidence from animal studies 
shall be consistent with the Category 2 classification. In other 
words, if there are also animal data available on the substance that 
warrant Category 1 classification, the substance shall be classified 
as Category 1.

A.9.2.7 Effects Considered To Support Classification

    A.9.2.7.1 Classification is supported by reliable evidence 
associating repeated exposure to the substance with a consistent and 
identifiable toxic effect.
    A.9.2.7.2 Evidence from human experience/incidents is usually 
restricted to reports of adverse health consequences, often with 
uncertainty about exposure conditions, and may not provide the 
scientific detail that can be obtained from well-conducted studies 
in experimental animals.
    A.9.2.7.3 Evidence from appropriate studies in experimental 
animals can furnish much more detail, in the form of clinical 
observations, hematology, clinical chemistry, macroscopic and 
microscopic pathological examination and this can often reveal 
hazards that may not be life-threatening but could indicate 
functional impairment. Consequently all available evidence, and 
relevance to human health, must be taken into consideration in the 
classification process. Relevant toxic effects in humans and/or 
animals include, but are not limited to:
    (a) Morbidity or death resulting from repeated or long-term 
exposure. Morbidity or death may result from repeated exposure, even 
to relatively low doses/concentrations, due to bioaccumulation of 
the substance or its metabolites, or due to the overwhelming of the 
de-toxification process by repeated exposure;
    (b) Significant functional changes in the central or peripheral 
nervous systems or other organ systems, including signs of central 
nervous system depression and effects on special senses (e.g., 
sight, hearing and sense of smell);
    (c) Any consistent and significant adverse change in clinical 
biochemistry, hematology, or urinalysis parameters;
    (d) Significant organ damage that may be noted at necropsy and/
or subsequently seen or confirmed at microscopic examination;

[[Page 17815]]

    (e) Multi-focal or diffuse necrosis, fibrosis or granuloma 
formation in vital organs with regenerative capacity;
    (f) Morphological changes that are potentially reversible but 
provide clear evidence of marked organ dysfunction (e.g., severe 
fatty change in the liver); and,
    (g) Evidence of appreciable cell death (including cell 
degeneration and reduced cell number) in vital organs incapable of 
regeneration.

A.9.2.8 Effects Considered Not To Support Classification

    Effects may be seen in humans and/or animals that do not justify 
classification. Such effects include, but are not limited to:
    (a) Clinical observations or small changes in bodyweight gain, 
food consumption or water intake that may have some toxicological 
importance but that do not, by themselves, indicate ``significant'' 
toxicity;
    (b) Small changes in clinical biochemistry, hematology or 
urinalysis parameters and/or transient effects, when such changes or 
effects are of doubtful or of minimal toxicological importance;
    (c) Changes in organ weights with no evidence of organ 
dysfunction;
    (d) Adaptive responses that are not considered toxicologically 
relevant;
    (e) Substance-induced species-specific mechanisms of toxicity, 
i.e., demonstrated with reasonable certainty to be not relevant for 
human health, shall not justify classification.

A.9.2.9 Guidance Values To Assist With Classification Based on the 
Results Obtained From Studies Conducted in Experimental Animals

    A.9.2.9.1 In studies conducted in experimental animals, reliance 
on observation of effects alone, without reference to the duration 
of experimental exposure and dose/concentration, omits a fundamental 
concept of toxicology, i.e., all substances are potentially toxic, 
and what determines the toxicity is a function of the dose/
concentration and the duration of exposure. In most studies 
conducted in experimental animals the test guidelines use an upper 
limit dose value.
    A.9.2.9.2 In order to help reach a decision about whether a 
substance shall be classified or not, and to what degree it shall be 
classified (Category 1 vs. Category 2), dose/concentration 
``guidance values'' are provided in Table A.9.1 for consideration of 
the dose/concentration which has been shown to produce significant 
health effects. The principal argument for proposing such guidance 
values is that all chemicals are potentially toxic and there has to 
be a reasonable dose/concentration above which a degree of toxic 
effect is acknowledged. Also, repeated-dose studies conducted in 
experimental animals are designed to produce toxicity at the highest 
dose used in order to optimize the test objective and so most 
studies will reveal some toxic effect at least at this highest dose. 
What is therefore to be decided is not only what effects have been 
produced, but also at what dose/concentration they were produced and 
how relevant is that for humans.
    A.9.2.9.3 Thus, in animal studies, when significant toxic 
effects are observed that indicate classification, consideration of 
the duration of experimental exposure and the dose/concentration at 
which these effects were seen, in relation to the suggested guidance 
values, provides useful information to help assess the need to 
classify (since the toxic effects are a consequence of the hazardous 
property(ies) and also the duration of exposure and the dose/
concentration).
    A.9.2.9.4 The decision to classify at all can be influenced by 
reference to the dose/concentration guidance values at or below 
which a significant toxic effect has been observed.
    A.9.2.9.5 The guidance values refer to effects seen in a 
standard 90-day toxicity study conducted in rats. They can be used 
as a basis to extrapolate equivalent guidance values for toxicity 
studies of greater or lesser duration, using dose/exposure time 
extrapolation similar to Haber's rule for inhalation, which states 
essentially that the effective dose is directly proportional to the 
exposure concentration and the duration of exposure. The assessment 
should be done on a case-by-case basis; for example, for a 28-day 
study the guidance values below would be increased by a factor of 
three.
    A.9.2.9.6 Thus for Category 1 classification, significant toxic 
effects observed in a 90-day repeated-dose study conducted in 
experimental animals and seen to occur at or below the (suggested) 
guidance values (C) as indicated in Table A.9.1 would justify 
classification:

   Table A.9.1--Guidance Values To Assist in Category 1 Classification
                     [Applicable to a 90-day study]
------------------------------------------------------------------------
                                                       Guidance values
      Route of exposure               Units         (dose/concentration)
------------------------------------------------------------------------
Oral (rat)..................  mg/kg body weight/    C <=10.
                               day.
Dermal (rat or rabbit)......  mg/kg body weight/    C <=20.
                               day.
Inhalation (rat) gas........  ppmV/6h/day.........  C <=50.
Inhalation (rat) vapor......  mg/liter/6h/day.....  C <=0.2.
Inhalation (rat) dust/mist/   mg/liter/6h/day.....  C <=0.02.
 fume.
------------------------------------------------------------------------

    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 values
      Route of exposure               Units         (dose/concentration)
------------------------------------------------------------------------
Oral (rat)..................  mg/kg body weight/    10 =100 mg/kg body weight/day by the oral route, and in addition there 
is supplementary information from other sources, e.g., other long-
term administration studies, or human case experience, which 
supports a conclusion that, in view of the weight of evidence, 
classification is prudent.

A.9.2.10 Other Considerations

    A.9.2.10.1 When a substance is characterized only by use of 
animal data the classification process includes reference to dose/
concentration guidance values as one of the elements that contribute 
to the weight of evidence approach.
    A.9.2.10.2 When well-substantiated human data are available 
showing a specific target organ toxic effect that can be reliably 
attributed to repeated or prolonged exposure to a substance, the 
substance shall be classified. Positive human data, regardless of 
probable dose, predominates over animal data. Thus, if a substance 
is unclassified because no specific target organ toxicity was seen 
at or below the dose/concentration guidance value for animal 
testing, if subsequent human incident data become available showing 
a specific target organ toxic effect, the substance shall be 
classified.
    A.9.2.10.3 A substance that has not been tested for specific 
target organ toxicity may in certain instances, where appropriate, 
be classified on the basis of data from a scientifically validated 
structure activity relationship and expert judgment-based 
extrapolation from a structural analogue that has previously been 
classified together with substantial support from consideration of 
other important factors such as formation of common significant 
metabolites.

A.9.3 Classification Criteria for Mixtures

    A.9.3.1 Mixtures are classified using the same criteria as for 
substances, or alternatively as described below. As with substances, 
mixtures may be classified for specific target organ toxicity 
following single exposure, repeated exposure, or both.

A.9.3.2 Classification of Mixtures When Data Are Available for the 
Complete Mixture

    When reliable and good quality evidence from human experience or 
appropriate studies in experimental animals, as described in the 
criteria for substances, is available for the mixture, then the 
mixture shall be classified by weight of evidence evaluation of 
these data. Care shall be exercised in evaluating data on mixtures, 
that the dose, duration, observation or analysis, do not render the 
results inconclusive.

A.9.3.3 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.9.3.3.1 Where the mixture itself has not been tested to 
determine its specific target organ toxicity, but there are 
sufficient data on both the individual ingredients and similar 
tested mixtures to adequately characterize the hazards of the 
mixture, these data shall be used in accordance with the following 
bridging principles as found in paragraph A.0.5 of this Appendix: 
Dilution; Batching; Concentration of mixtures; Interpolation within 
one 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.

   Table A.9.3--Cut-Off Value/Concentration Limits of Ingredients of a
    Mixture Classified as a Specific Target Organ Toxicant That Would
        Trigger Classification of the Mixture as Category 1 or 2
------------------------------------------------------------------------
                                           Cut-off values/concentration
                                                 limits triggering
                                           classification of a  mixture
        Ingredient classified as:                       as:
                                         -------------------------------
                                            Category 1      Category 2
------------------------------------------------------------------------
Category 1 Target organ toxicant........          >=1.0%  ..............
Category 2 Target organ toxicant........  ..............          >=1.0%
------------------------------------------------------------------------

    A.9.3.4.2 These cut-off values and consequent classifications 
shall be applied equally and appropriately to both single- and 
repeated-dose target organ toxicants.
    A.9.3.4.3 Mixtures shall be classified for either or both 
single- and repeated-dose toxicity independently.
    A.9.3.4.4 Care shall be exercised when toxicants affecting more 
than one organ system are combined that the potentiation or 
synergistic interactions are considered, because certain substances 
can cause specific target organ toxicity at <1% concentration when 
other ingredients in the mixture are known to potentiate its toxic 
effect.

A.10 ASPIRATION HAZARD

A.10.1 Definitions and General and Specific Considerations

    A.10.1.1 Aspiration means the entry of a liquid or solid 
chemical directly through the oral or nasal cavity, or indirectly 
from vomiting, into the trachea and lower respiratory system.
    A.10.1.2 Aspiration toxicity includes severe acute effects such 
as chemical pneumonia, varying degrees of pulmonary injury or death 
following aspiration.
    A.10.1.3 Aspiration is initiated at the moment of inspiration, 
in the time required to take one breath, as the causative material 
lodges at the crossroad of the upper respiratory and digestive 
tracts in the laryngopharyngeal region.
    A.10.1.4 Aspiration of a substance or mixture can occur as it is 
vomited following ingestion. This may have consequences for 
labeling, particularly where, due to acute toxicity, a 
recommendation may be considered to induce vomiting after ingestion. 
However, if the substance/mixture also presents an aspiration 
toxicity hazard, the recommendation to induce vomiting may need to 
be modified.

A.10.1.5 Specific Considerations

    A.10.1.5.1 The classification criteria refer to kinematic 
viscosity. The following provides the conversion between dynamic and 
kinematic viscosity:
[GRAPHIC] [TIFF OMITTED] TR26MR12.130


[[Page 17817]]


    A.10.1.5.2 Although the definition of aspiration in A.10.1.1 
includes the entry of solids into the respiratory system, 
classification according to (b) in table A.10.1 for Category 1 is 
intended to apply to liquid substances and mixtures only.
    A.10.1.5.3 Classification of aerosol/mist products.
    Aerosol and mist products are usually dispensed in containers 
such as self-pressurized containers, trigger and pump sprayers. 
Classification for these products shall be considered if their use 
may form a pool of product in the mouth, which then may be 
aspirated. If the mist or aerosol from a pressurized container is 
fine, a pool may not be formed. On the other hand, if a pressurized 
container dispenses product in a stream, a pool may be formed that 
may then be aspirated. Usually, the mist produced by trigger and 
pump sprayers is coarse and therefore, a pool may be formed that 
then may be aspirated. When the pump mechanism may be removed and 
contents are available to be swallowed then the classification of 
the products should be considered.

A.10.2 Classification Criteria for Substances

             Table A.10.1--Criteria for Aspiration Toxicity
------------------------------------------------------------------------
                Category                             Criteria
------------------------------------------------------------------------
Category 1: Chemicals known to cause     A substance shall be classified
 human aspiration toxicity hazards or     in Category 1:
 to be regarded as if they cause human   (a) If reliable and good
 aspiration toxicity hazard.              quality human evidence
                                          indicates that it causes
                                          aspiration toxicity (See
                                          note); or
                                         (b) If it is a hydrocarbon and
                                          has a kinematic viscosity
                                          <=20.5 mm\2\/s, measured at 40
                                          [deg]C.
------------------------------------------------------------------------
Note: Examples of substances included in Category 1 are certain
  hydrocarbons, turpentine and pine oil.

A.10.3 Classification Criteria for Mixtures

A.10.3.1 Classification When Data Are Available for the Complete 
Mixture

    A mixture shall be classified in Category 1 based on reliable 
and good quality human evidence.

A.10.3.2 Classification of Mixtures When Data Are Not Available for the 
Complete Mixture: Bridging Principles

    A.10.3.2.1 Where the mixture itself has not been tested to 
determine its aspiration toxicity, but there are sufficient data on 
both the individual ingredients and similar tested mixtures to 
adequately characterize the hazard of the mixture, these data shall 
be used in accordance with the following bridging principles as 
found in paragraph A.0.5 of this Appendix: Dilution; Batching; 
Concentration of mixtures; Interpolation within one 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 CRITERIA (MANDATORY)

B.1 EXPLOSIVES

B.1.1 Definitions and General Considerations

    B.1.1.1 An explosive chemical is a solid or liquid chemical 
which is in itself capable by chemical reaction of producing gas at 
such a temperature and pressure and at such a speed as to cause 
damage to the surroundings. Pyrotechnic chemicals are included even 
when they do not evolve gases.
    A pyrotechnic chemical is a chemical designed to produce an 
effect by heat, light, sound, gas or smoke or a combination of these 
as the result of non-detonative self-sustaining exothermic chemical 
reactions.
    An explosive item is an item containing one or more explosive 
chemicals.
    A pyrotechnic item is an item containing one or more pyrotechnic 
chemicals.
    An unstable explosive is an explosive which is thermally 
unstable and/or too sensitive for normal handling, transport, or 
use.
    An intentional explosive is a chemical or item which is 
manufactured with a view to produce a practical explosive or 
pyrotechnic effect.
    B.1.1.2 The class of explosives comprises:
    (a) Explosive chemicals;
    (b) Explosive items, except devices containing explosive 
chemicals in such quantity or of such a character that their 
inadvertent or accidental ignition or initiation shall not cause any 
effect external to the device either by projection, fire, smoke, 
heat or loud noise; and
    (c) Chemicals and items not included under (a) and (b) above 
which are manufactured with the view to producing a practical 
explosive or pyrotechnic effect.

B.1.2 Classification Criteria

    Chemicals and items of this class shall be classified as 
unstable explosives or shall be assigned to one of the following six 
divisions depending on the type of hazard they present:
    (a) Division 1.1--Chemicals and items which have a mass 
explosion hazard (a mass explosion is one which affects almost the 
entire quantity present virtually instantaneously);
    (b) Division 1.2--Chemicals and items which have a projection 
hazard but not a mass explosion hazard;
    (c) Division 1.3--Chemicals and items which have a fire hazard 
and either a minor blast hazard or a minor projection hazard or 
both, but not a mass explosion hazard:
    (i) Combustion of which gives rise to considerable radiant heat; 
or
    (ii) Which burn one after another, producing minor blast or 
projection effects or both;
    (d) Division 1.4--Chemicals and items which present no 
significant hazard: chemicals and items which present only a small 
hazard in the event of ignition or initiation. The effects are 
largely confined to the package and no projection of fragments of 
appreciable size or range is to be expected. An external fire shall 
not cause virtually instantaneous explosion of almost the entire 
contents of the package;
    (e) Division 1.5--Very insensitive chemicals which have a mass 
explosion hazard: chemicals which have a mass explosion hazard but 
are so insensitive that there is very little probability of 
initiation or of transition from burning to detonation under normal 
conditions;
    (f) Division 1.6--Extremely insensitive items which do not have 
a mass explosion hazard: items which contain only extremely 
insensitive detonating chemicals and which demonstrate a negligible 
probability of accidental initiation or propagation.

B.1.3 Additional Classification Considerations

    B.1.3.1 Explosives shall be classified as unstable explosives or 
shall be assigned to one of the six divisions identified in B.1.2 in 
accordance with the three step procedure in Part I of the UN ST/SG/
AC.10 (incorporated by reference; See Sec.  1910.6). The first step 
is to ascertain whether the substance or mixture has explosive 
effects (Test Series 1). The second step is the acceptance procedure 
(Test Series 2 to 4) and the third step is the assignment to a 
hazard division (Test Series 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

[[Page 17818]]

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.1.3.1 is aimed at identifying the presence of such 
reactive groups and the potential for rapid energy release. If the 
screening procedure identifies the chemical as a potential 
explosive, the acceptance procedure (See section 10.3 of the UN ST/
SG/AC.10 (incorporated by reference; See Sec.  1910.6)) is necessary 
for classification.
    Note: Neither a Series 1 type (a) propagation of detonation test 
nor a Series 2 type (a) test of sensitivity to detonative shock is 
necessary if the exothermic decomposition energy of organic 
materials is less than 800 J/g.
    B.1.3.3 If a mixture contains any known explosives, the 
acceptance procedure is necessary for classification.
    B.1.3.4 A chemical is not classified as explosive if:
    (a) There are no chemical groups associated with explosive 
properties present in the molecule. Examples of groups which may 
indicate explosive properties are given in Table A6.1 in Appendix 6 
of the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6); 
or
    (b) The substance contains chemical groups associated with 
explosive properties which include oxygen and the calculated oxygen 
balance is less than -200.
    The oxygen balance is calculated for the chemical reaction:

CxHyOz + [x + (y/4) - (z/2)] 
O2 [rarr] x. CO2 + (y/2) H2O

using the formula:

oxygen balance = -1600 [2x +(y/2) -z]/molecular weight;
    or
    (c) The organic substance or a homogenous mixture of organic 
substances contains chemical groups associated with explosive 
properties but the exothermic decomposition energy is less than 500 
J/g and the onset of exothermic decomposition is below 500 [deg]C 
(932 [deg]F). The exothermic decomposition energy may be determined 
using a suitable calorimetric technique; or
    (d) For mixtures of inorganic oxidizing substances with organic 
material(s), the concentration of the inorganic oxidizing substance 
is:
    (i) Less than 15%, by mass, if the oxidizing substance is 
assigned to Category 1 or 2;
    (ii) Less than 30%, by mass, if the oxidizing substance is 
assigned to Category 3.

B.2 FLAMMABLE GASES

B.2.1 Definition

    Flammable gas means a gas having a flammable range with air at 
20 [deg]C (68 [deg]F) and a standard pressure of 101.3 kPa (14.7 
psi).

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 ISO 10156 (incorporated by reference; See Sec.  
1910.6). Where insufficient data are available to use this method, 
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% flammable components and the chemical heat of
                                               combustion is >=30 kJ/g; or
                                              (a) For spray aerosols, in the ignition distance test, ignition
                                               occurs at a distance >=75 cm (29.5 in), or
                                              (b) For foam aerosols, in the aerosol foam flammability test.
                                              (i) The flame height is >=20 cm (7.87 in) and the flame duration
                                               >=2 s; or
                                              (ii) The flame height is >=4 cm (1.57 in) and the flame duration
                                               >=7 s.
2...........................................  Contains >1% flammable components, or the heat of combustion is
                                               >=20 kJ/g; and
                                              (a) for spray aerosols, in the ignition distance test, ignition
                                               occurs at a distance >=15 cm (5.9 in), or in the enclosed space
                                               ignition test, the
                                              (i) Time equivalent is <=300 s/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.
----------------------------------------------------------------------------------------------------------------


[[Page 17819]]

    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] TR26MR12.067

Where:

[Delta]Hc = chemical heat of combustion (kJ/g);
wi% = mass fraction of component i in the product;
[Delta]Hc(i) = specific heat of combustion (kJ/g) of component i in 
the product;

    The chemical heats of combustion shall be found in literature, 
calculated or determined by tests (See ASTM D240-02, ISO 13943, 
Sections 86.1 to 86.3, and NFPA 30B (incorporated by reference; See 
Sec.  1910.6)).
    B.3.3.3 The Ignition Distance Test, Enclosed Space Ignition Test 
and Aerosol Foam Flammability Test shall be performed in accordance 
with sub-sections 31.4, 31.5 and 31.6 of the of the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6).

B.4 OXIDIZING GASES

B.4.1 Definition

    Oxidizing gas means any gas which may, generally by providing 
oxygen, cause or contribute to the combustion of other material more 
than air does.
    Note: ``Gases which cause or contribute to the combustion of 
other material more than air does'' means pure gases or gas mixtures 
with an oxidizing power greater than 23.5% (as determined by a 
method specified in ISO 10156 or 10156-2 (incorporated by reference, 
See Sec.  1910.6) or an equivalent testing method.)

B.4.2 Classification Criteria

    An oxidizing gas shall be classified in a single category for 
this class in accordance with Table B.4.1:

                                    Table B.4.1--Criteria for Oxidizing Gases
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Any gas which may, generally by providing oxygen, cause or
                                               contribute to the combustion of other material more than air
                                               does.
----------------------------------------------------------------------------------------------------------------

B.4.3 Additional Classification Considerations

    Classification shall be in accordance with tests or calculation 
methods as described in ISO 10156 (incorporated by reference; See 
Sec.  1910.6) and ISO 10156-2 (incorporated by reference; See Sec.  
1910.6).

B.5 GASES UNDER PRESSURE

B.5.1 Definition

    Gases under pressure are gases which are contained in a 
receptacle at a pressure of 200 kPa (29 psi) (gauge) or more, 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
                                               (-8 [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.

B.6 FLAMMABLE LIQUIDS

B.6.1 Definition

    Flammable liquid means a liquid having a flash point of not more 
than 93 [deg]C (199.4 [deg]F).
    Flash point means the minimum temperature at which a liquid 
gives off vapor in sufficient concentration to form an ignitable 
mixture with air near the surface of the liquid, as determined by a 
method identified in Section B.6.3.

B.6.2 Classification Criteria

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

                                                       Table B.6.1--Criteria for Flammable Liquids
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Category                                                                     Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...........................................  Flash point <23 [deg]C (73.4 [deg]F) and initial boiling point <=35 [deg]C (95 [deg]F).

[[Page 17820]]

 
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 ASTM D56-
05, ASTM D3278, ASTM D3828, ASTM D93-08 (incorporated by reference; 
See Sec.  1910.6), or any other method specified in GHS Revision 3, 
Chapter 2.6.
    The initial boiling point shall be determined in accordance with 
ASTM D86-07a or ASTM D1078 (incorporated by reference; See Sec.  
1910.6).

B.7 FLAMMABLE SOLIDS

B.7.1 Definitions

    Flammable solid means a solid which is a readily combustible 
solid, or which may cause or contribute to fire through friction.
    Readily combustible solids are powdered, granular, or pasty 
chemicals which are dangerous if they can be easily ignited by brief 
contact with an ignition source, such as a burning match, and if the 
flame spreads rapidly.

B.7.2 Classification Criteria

    B.7.2.1 Powdered, granular or pasty chemicals shall be 
classified as flammable solids when the time of burning of one or 
more of the test runs, performed in accordance with the test method 
described in the UN ST/SG/AC.10 (incorporated by reference; See 
Sec.  1910.6), Part III, sub-section 33.2.1, is less than 45 s or 
the rate of burning is more than 2.2 mm/s (0.0866 in/s).
    B.7.2.2 Powders of metals or metal alloys shall be classified as 
flammable solids when they can be ignited and the reaction spreads 
over the whole length of the sample in 10 min or less.
    B.7.2.3 Solids which may cause fire through friction shall be 
classified in this class by analogy with existing entries (e.g., 
matches) until definitive criteria are established.
    B.7.2.4 A flammable solid shall be classified in one of the two 
categories for this class using Method N.1 as described in Part III, 
sub-section 33.2.1 of the UN ST/SG/AC.10 (incorporated by reference; 
See Sec.  1910.6), in accordance with Table B.7.1:

               Table B.7.1--Criteria for Flammable Solids
------------------------------------------------------------------------
                Category                             Criteria
------------------------------------------------------------------------
1......................................  Burning rate test:
                                            Chemicals other than metal
                                             powders:
                                              (a) Wetted zone does not
                                               stop fire; and
                                              (b) Burning time <45 s or
                                               burning rate >2.2 mm/s.
                                            Metal powders: Burning time
                                             <=5 min.
2......................................  Burning rate test:
                                            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 (110 lb) package.
    B.8.2.2 Mixtures of oxidizing substances, meeting the criteria 
for classification as oxidizing liquids or oxidizing solids, which 
contain 5% or more of combustible organic substances and which do 
not meet the criteria mentioned in B.8.2.1 (a), (c), (d) or (e), 
shall be subjected to the self-reactive chemicals classification 
procedure in B.8.2.3. Such a mixture showing the properties of a 
self-reactive chemical type B to F shall be classified as a self-
reactive chemical.
    B.8.2.3 Self-reactive chemicals shall be classified in one of 
the seven categories of ``types A to G'' for this class, according 
to the following principles:
    (a) Any self-reactive chemical which can detonate or deflagrate 
rapidly, as packaged, will be defined as self-reactive chemical TYPE 
A;
    (b) Any self-reactive chemical possessing explosive properties 
and which, as packaged, neither detonates nor deflagrates rapidly, 
but is liable to undergo a thermal explosion in that package will be 
defined as self-reactive chemical TYPE B;
    (c) Any self-reactive chemical possessing explosive properties 
when the chemical as packaged cannot detonate or deflagrate rapidly 
or undergo a thermal explosion will be defined as self-reactive 
chemical TYPE C;
    (d) Any self-reactive chemical which in laboratory testing meets 
the criteria in (d)(i), (ii), or (iii) will be defined as self-
reactive chemical TYPE D:
    (i) Detonates partially, does not deflagrate rapidly and shows 
no violent effect when heated under confinement; or

[[Page 17821]]

    (ii) Does not detonate at all, deflagrates slowly and shows no 
violent effect when heated under confinement; or
    (iii) Does not detonate or deflagrate at all and shows a medium 
effect when heated under confinement;
    (e) Any self-reactive chemical which, in laboratory testing, 
neither detonates nor deflagrates at all and shows low or no effect 
when heated under confinement will be defined as self-reactive 
chemical TYPE E;
    (f) Any self-reactive chemical which, in laboratory testing, 
neither detonates in the cavitated state nor deflagrates at all and 
shows only a low or no effect when heated under confinement as well 
as low or no explosive power will be defined as self-reactive 
chemical TYPE F;
    (g) Any self-reactive chemical which, in laboratory testing, 
neither detonates in the cavitated state nor deflagrates at all and 
shows no effect when heated under confinement nor any explosive 
power, provided that it is thermally stable (self-accelerating 
decomposition temperature is 60 [deg]C (140 [deg]F) to 75 [deg]C 
(167 [deg]F) for a 50 kg (110 lb) package), and, for liquid 
mixtures, a diluent having a boiling point greater than or equal to 
150 [deg]C (302 [deg]F) is used for desensitization will be defined 
as self-reactive chemical TYPE G. If the mixture is not thermally 
stable or a diluent having a boiling point less than 150 [deg]C (302 
[deg]F) is used for desensitization, the mixture shall be defined as 
self-reactive chemical TYPE F.

B.8.3 Additional Classification Considerations

    B.8.3.1 For purposes of classification, the properties of self-
reactive chemicals shall be determined in accordance with test 
series A to H as described in Part II of the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6).
    B.8.3.2 Self-accelerating decomposition temperature (SADT) shall 
be determined in accordance with the UN ST/SG/AC.10, Part II, 
section 28 (incorporated by reference; See Sec.  1910.6).
    B.8.3.3 The classification procedures for self-reactive 
substances and mixtures need not be applied if:
    (a) There are no chemical groups present in the molecule 
associated with explosive or self-reactive properties; examples of 
such groups are given in Tables A6.1 and A6.2 in the Appendix 6 of 
the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6); or
    (b) For a single organic substance or a homogeneous mixture of 
organic substances, the estimated SADT is greater than 75 [deg]C 
(167 [deg]F) or the exothermic decomposition energy is less than 300 
J/g. The onset temperature and decomposition energy may be estimated 
using a suitable calorimetric technique (See 20.3.3.3 in Part II of 
the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6)).

B.9 PYROPHORIC LIQUIDS

B.9.1 Definition

    Pyrophoric liquid means a liquid which, even in small 
quantities, is liable to ignite within five minutes after coming 
into contact with air.

B.9.2 Classification Criteria

    A pyrophoric liquid shall be classified in a single category for 
this class using test N.3 in Part III, sub-section 33.3.1.5 of the 
UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), in 
accordance with Table B.9.1:

                                  Table B.9.1--Criteria for Pyrophoric Liquids
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  The liquid ignites within 5 min when added to an inert carrier and
                                               exposed to air, or it ignites or chars a filter paper on contact
                                               with air within 5 min.
----------------------------------------------------------------------------------------------------------------

B.9.3 Additional Classification Considerations

    The classification procedure for pyrophoric liquids need not be 
applied when experience in production or handling shows that the 
chemical does not ignite spontaneously on coming into contact with 
air at normal temperatures (i.e., the substance is known to be 
stable at room temperature for prolonged periods of time (days)).

B.10 PYROPHORIC SOLIDS

B.10.1 Definition

    Pyrophoric solid means a solid which, even in small quantities, 
is liable to ignite within five minutes after coming into contact 
with air.

B.10.2 Classification Criteria

    A pyrophoric solid shall be classified in a single category for 
this class using test N.2 in Part III, sub-section 33.3.1.4 of the 
UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), in 
accordance with Table B.10.1:

                                                      Table B.10.1--Criteria for Pyrophoric Solids
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   Category                                                                     Criteria
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.............................................  The solid ignites within 5 min of coming into contact with air.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Note: Classification of solid chemicals shall be based on tests 
performed on the chemical as presented. If, for example, for the 
purposes of supply or transport, the same chemical is to be 
presented in a physical form different from that which was tested 
and which is considered likely to materially alter its performance 
in a classification test, classification must be based on testing of 
the chemical in the new form.

B.10.3 Additional Classification Considerations

    The classification procedure for pyrophoric solids need not be 
applied when experience in production or handling shows that the 
chemical does not ignite spontaneously on coming into contact with 
air at normal temperatures (i.e., the chemical is known to be stable 
at room temperature for prolonged periods of time (days)).

B.11 SELF-HEATING CHEMICALS

B.11.1 Definition

    A self-heating chemical is a solid or liquid chemical, other 
than a pyrophoric liquid or solid, which, by reaction with air and 
without energy supply, is liable to self-heat; this chemical differs 
from a pyrophoric liquid or solid in that it will ignite only when 
in large amounts (kilograms) and after long periods of time (hours 
or days).
    Note: Self-heating of a substance or mixture is a process where 
the gradual reaction of that substance or mixture with oxygen (in 
air) generates heat. If the rate of heat production exceeds the rate 
of heat loss, then the temperature of the substance or mixture will 
rise which, after an induction time, may lead to self-ignition and 
combustion.

B.11.2 Classification Criteria

    B.11.2.1 A self-heating chemical shall be classified in one of 
the two categories for this class if, in tests performed in 
accordance with test method N.4 in Part III, sub-section 33.3.1.6 of 
the UN ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), 
the result meets the criteria shown in Table B.11.1.

[[Page 17822]]



                                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 ST/SG/AC.10 (incorporated by reference; See Sec.  1910.6), 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 ST/SG/AC.10 (incorporated by reference; See Sec.  
1910.6), in accordance with Table B.13.1:

                                  Table B.13.1--Criteria for Oxidizing Liquids
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Any chemical which, in the 1:1 mixture, by mass, of chemical and
                                               cellulose tested, spontaneously ignites; or the mean pressure
                                               rise time of a 1:1 mixture, by mass, of chemical and cellulose is
                                               less than that of a 1:1 mixture, by mass, of 50% perchloric acid
                                               and cellulose;

[[Page 17823]]

 
2...........................................  Any chemical which, in the 1:1 mixture, by mass, of chemical and
                                               cellulose tested, exhibits a mean pressure rise time less than or
                                               equal to the mean pressure rise time of a 1:1 mixture, by mass,
                                               of 40% aqueous sodium chlorate solution and cellulose; and the
                                               criteria for Category 1 are not met;
3...........................................  Any chemical which, in the 1:1 mixture, by mass, of chemical and
                                               cellulose tested, exhibits a mean pressure rise time less than or
                                               equal to the mean pressure rise time of a 1:1 mixture, by mass,
                                               of 65% aqueous nitric acid and cellulose; and the criteria for
                                               Categories 1 and 2 are not met.
----------------------------------------------------------------------------------------------------------------

B.13.3 Additional Classification Considerations

    B.13.3.1 For organic chemicals, the classification procedure for 
this class shall not be applied if:
    (a) The chemical does not contain oxygen, fluorine or chlorine; 
or
    (b) The chemical contains oxygen, fluorine or chlorine and these 
elements are chemically bonded only to carbon or hydrogen.
    B.13.3.2 For inorganic chemicals, the classification procedure 
for this class shall not be applied if the chemical does not contain 
oxygen or halogen atoms.
    B.13.3.3 In the event of divergence between test results and 
known experience in the handling and use of chemicals which shows 
them to be oxidizing, judgments based on known experience shall take 
precedence over test results.
    B.13.3.4 In cases where chemicals generate a pressure rise (too 
high or too low), caused by chemical reactions not characterizing 
the oxidizing properties of the chemical, the test described in Part 
III, sub-section 34.4.2 of the UN ST/SG/AC.10 (incorporated by 
reference; See Sec.  1910.6) shall be repeated with an inert 
substance (e.g., diatomite (kieselguhr)) in place of the cellulose 
in order to clarify the nature of the reaction.

B.14 OXIDIZING SOLIDS

B.14.1 Definition

    Oxidizing solid means a solid which, while in itself is not 
necessarily combustible, may, generally by yielding oxygen, cause, 
or contribute to, the combustion of other material.

B.14.2 Classification Criteria

    An oxidizing solid shall be classified in one of the three 
categories for this class using test O.1 in Part III, sub-section 
34.4.1 of the UN ST/SG/AC.10 (incorporated by reference; See Sec.  
1910.6), in accordance with Table B.14.1:

                                   Table B.14.1--Criteria for Oxidizing Solids
----------------------------------------------------------------------------------------------------------------
                  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 test results and 
known experience in the handling and use of chemicals which shows 
them to be oxidizing, judgements based on known experience shall 
take precedence over test results.

B.15 ORGANIC PEROXIDES

B.15.1 Definition

    B.15.1.1 Organic peroxide means a liquid or solid organic 
chemical which contains the bivalent -0-0- structure and as such is 
considered a derivative of hydrogen peroxide, where one or both of 
the hydrogen atoms have been replaced by organic radicals. The term 
organic peroxide includes organic peroxide mixtures containing at 
least one organic peroxide. Organic peroxides are thermally unstable 
chemicals, which may undergo exothermic self-accelerating 
decomposition. In addition, they may have one or more of the 
following properties:
    (a) Be liable to explosive decomposition;
    (b) Burn rapidly;
    (c) Be sensitive to impact or friction;
    (d) React dangerously with other substances.
    B.15.1.2 An organic peroxide is regarded as possessing explosive 
properties when in laboratory testing the formulation is liable to 
detonate, to deflagrate rapidly or to show a violent effect when 
heated under confinement.

B.15.2 Classification Criteria

    B.15.2.1 Any organic peroxide shall be considered for 
classification in this class, unless it contains:
    (a) Not more than 1.0% available oxygen from the organic 
peroxides when containing not more than 1.0% hydrogen peroxide; or
    (b) Not more than 0.5% available oxygen from the organic 
peroxides when containing more than 1.0% but not more than 7.0% 
hydrogen peroxide.
    Note: The available oxygen content (%) of an organic peroxide 
mixture is given by the formula:
[GRAPHIC] [TIFF OMITTED] TR26MR12.068


[[Page 17824]]


Where:

ni = number of peroxygen groups per molecule of organic peroxide i;
ci = concentration (mass %) of organic peroxide i;
mi = molecular mass of organic peroxide i.

    B.15.2.2 Organic peroxides shall be classified in one of the 
seven categories of ``Types A to G'' for this class, according to 
the following principles:
    (a) Any organic peroxide which, as packaged, can detonate or 
deflagrate rapidly shall be defined as organic peroxide TYPE A;
    (b) Any organic peroxide possessing explosive properties and 
which, as packaged, neither detonates nor deflagrates rapidly, but 
is liable to undergo a thermal explosion in that package shall be 
defined as organic peroxide TYPE B;
    (c) Any organic peroxide possessing explosive properties when 
the chemical as packaged cannot detonate or deflagrate rapidly or 
undergo a thermal explosion shall be defined as organic peroxide 
TYPE C;
    (d) Any organic peroxide which in laboratory testing meets the 
criteria in (d)(i), (ii), or (iii) shall be defined as organic 
peroxide TYPE D:
    (i) Detonates partially, does not deflagrate rapidly and shows 
no violent effect when heated under confinement; or
    (ii) Does not detonate at all, deflagrates slowly and shows no 
violent effect when heated under confinement; or
    (iii) Does not detonate or deflagrate at all and shows a medium 
effect when heated under confinement;
    (e) Any organic peroxide which, in laboratory testing, neither 
detonates nor deflagrates at all and shows low or no effect when 
heated under confinement shall be defined as organic peroxide TYPE 
E;
    (f) Any organic peroxide which, in laboratory testing, neither 
detonates in the cavitated state nor deflagrates at all and shows 
only a low or no effect when heated under confinement as well as low 
or no explosive power shall be defined as organic peroxide TYPE F;
    (g) Any organic peroxide which, in laboratory testing, neither 
detonates in the cavitated state nor deflagrates at all and shows no 
effect when heated under confinement nor any explosive power, 
provided that it is thermally stable (self-accelerating 
decomposition temperature is 60 [deg]C (140 [deg]F) or higher for a 
50 kg (110 lb) package), and, for liquid mixtures, a diluent having 
a boiling point of not less than 150 [deg]C (302 [deg]F) is used for 
desensitization, shall be defined as organic peroxide TYPE G. If the 
organic peroxide is not thermally stable or a diluent having a 
boiling point less than 150 [deg]C (302 [deg]F) is used for 
desensitization, it shall be defined as organic peroxide TYPE F.

B.15.3 Additional Classification Considerations

    B.15.3.1 For purposes of classification, the properties of 
organic peroxides shall be determined in accordance with test series 
A to H as described in Part II of the UN ST/SG/AC.10 (incorporated 
by reference; See Sec.  1910.6).
    B.15.3.2 Self-accelerating decomposition temperature (SADT) 
shall be determined in accordance with the UN ST/SG/AC.10 
(incorporated by reference; See Sec.  1910.6), Part II, section 28.
    B.15.3.3 Mixtures of organic peroxides may be classified as the 
same type of organic peroxide as that of the most dangerous 
ingredient. However, as two stable ingredients can form a thermally 
less stable mixture, the SADT of the mixture shall be determined.

B.16 CORROSIVE TO METALS

B.16.1 Definition

    A chemical which is corrosive to metals means a chemical which 
by chemical action will materially damage, or even destroy, metals.

B.16.2 Classification Criteria

    A chemical which is corrosive to metals shall be classified in a 
single category for this class, using the test in Part III, sub-
section 37.4 of the UN ST/SG/AC.10 (incorporated by reference; See 
Sec.  1910.6), in accordance with Table B.16.1:

                             Table B.16.1--Criteria for Chemicals Corrosive to Metal
----------------------------------------------------------------------------------------------------------------
                  Category                                                 Criteria
----------------------------------------------------------------------------------------------------------------
1...........................................  Corrosion rate on either steel or aluminium surfaces exceeding
                                               6.25 mm per year at a test temperature of 55 [deg]C (131 [deg]F)
                                               when tested on both materials.
----------------------------------------------------------------------------------------------------------------

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

B.16.3 Additional Classification Considerations

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

APPENDIX C TO Sec.  1910.1200--ALLOCATION OF LABEL ELEMENTS (MANDATORY)

    C.1 The label for each hazardous chemical shall include the 
product identifier used on the safety data sheet.
    C.1.1 The labels on shipped containers shall also include the 
name, address, and telephone number of the chemical manufacturer, 
importer, or responsible party.
    C.2 The label for each hazardous chemical that is classified 
shall include the signal word, hazard statement(s), pictogram(s), 
and precautionary statement(s) specified in C.4 for each hazard 
class and associated hazard category, except as provided for in 
C.2.1 through C.2.4.

C.2.1 Precedence of Hazard Information

    C.2.1.1 If the signal word ``Danger'' is included, the signal 
word ``Warning'' shall not appear;
    C.2.1.2 If the skull and crossbones pictogram is included, the 
exclamation mark pictogram shall not appear where it is used for 
acute toxicity;
    C.2.1.3 If the corrosive pictogram is included, the exclamation 
mark pictogram shall not appear where it is used for skin or eye 
irritation;
    C.2.1.4 If the health hazard pictogram is included for 
respiratory sensitization, the exclamation mark pictogram shall not 
appear where it is used for skin sensitization or for skin or eye 
irritation.

C.2.2 Hazard Statement Text

    C.2.2.1 The text of all applicable hazard statements shall 
appear on the label, except as otherwise specified. The information 
in italics shall be included as part of the hazard statement as 
provided. For example: ``causes damage to organs (state all organs 
affected) through prolonged or repeated exposure (state route of 
exposure if no other routes of exposure cause the hazard)''. Hazard 
statements may be combined where appropriate to reduce the 
information on the label and improve readability, as long as all of 
the hazards are conveyed as required.
    C.2.2.2 If the chemical manufacturer, importer, or responsible 
party can demonstrate that all or part of the hazard statement is 
inappropriate to a specific substance or mixture, the corresponding 
statement may be omitted from the label.

C.2.3 Pictograms

    C.2.3.1 Pictograms shall be in the shape of a square set at a 
point and shall include a black hazard symbol on a white background 
with a red frame sufficiently wide to be clearly visible. A square 
red frame set at a point without a hazard symbol is not a pictogram 
and is not permitted on the label.

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C.2.4 Precautionary Statement Text

    C.2.4.1 There are four types of precautionary statements 
presented, ``prevention,'' ``response,'' ``storage,'' and 
``disposal.'' The core part of the precautionary statement is 
presented in bold print. This is the text, except as otherwise 
specified, that shall appear on the label. Where additional 
information is required, it is indicated in plain text.
    C.2.4.2 When a backslash or diagonal mark (/) appears in the 
precautionary statement text, it indicates that a choice has to be 
made between the separated phrases. In such cases, the chemical 
manufacturer, importer, or responsible party can choose the most 
appropriate phrase(s). For example, ``Wear protective gloves/
protective clothing/eye protection/face protection'' could read 
``wear eye protection''.
    C.2.4.3 When three full stops (* * *) appear in the 
precautionary statement text, they indicate that all applicable 
conditions are not listed. For example, in ``Use explosion-proof 
electrical/ventilating/lighting/* * */equipment'', the use of ``* * 
*'' indicates that other equipment may need to be specified. In such 
cases, the chemical manufacturer, importer, or responsible party can 
choose the other conditions to be specified.
    C.2.4.4 When text in italics is used in a precautionary 
statement, this indicates specific conditions applying to the use or 
allocation of the precautionary statement. For example, ``Use 
explosion-proof electrical/ventilating/lighting/* * */equipment'' is 
only required for flammable solids ``if dust clouds can occur''. 
Text in italics is intended to be an explanatory, conditional note 
and is not intended to appear on the label.
    C.2.4.5 Where square brackets ([ ]) appear around text in a 
precautionary statement, this indicates that the text in square 
brackets is not appropriate in every case and should be used only in 
certain circumstances. In these cases, conditions for use explaining 
when the text should be used are provided. For example, one 
precautionary statement states: ``[In case of inadequate 
ventilation] wear respiratory protection.'' This statement is given 
with the condition for use ``- text in square brackets may be used 
if additional information is provided with the chemical at the point 
of use that explains what type of ventilation would be adequate for 
safe use''. This means that, if additional information is provided 
with the chemical explaining what type of ventilation would be 
adequate for safe use, the text in square brackets should be used 
and the statement would read: ``In case of inadequate ventilation 
wear respiratory protection.'' However, if the chemical is supplied 
without such ventilation information, the text in square brackets 
should not be used, and the precautionary statement should read: 
``Wear respiratory protection.''
    C.2.4.6 Precautionary statements may be combined or consolidated 
to save label space and improve readability. For example, ``Keep 
away from heat, sparks and open flame,'' ``Store in a well-
ventilated place'' and ``Keep cool'' can be combined to read ``Keep 
away from heat, sparks and open flame and store in a cool, well-
ventilated place.''
    C.2.4.7 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 chemical 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.2.4.8 If the chemical manufacturer, importer, or responsible 
party can demonstrate that a precautionary statement is 
inappropriate to a specific substance or mixture, the precautionary 
statement may be omitted from the label.

C.3 Supplementary Hazard Information

    C.3.1 To ensure that non-standardized information does not lead 
to unnecessarily wide variation or undermine the required 
information, supplementary information on the label is limited to 
when it provides further detail and does not contradict or cast 
doubt on the validity of the standardized hazard information.
    C.3.2 Where the chemical manufacturer, importer, or distributor 
chooses to add supplementary information on the label, the placement 
of supplemental information shall not impede identification of 
information required by this section.
    C.3.3 Where an ingredient with unknown acute toxicity is used in 
a mixture at a concentration >=1%, and the mixture is not classified 
based on testing of the mixture as a whole, a statement that X% of 
the mixture consists of ingredient(s) of unknown acute toxicity is 
required on the label.
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BILLING CODE 4510-26-C

[[Page 17884]]

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 within a section, the SDS shall 
clearly indicate that no applicable information is available. 
Sections 12-15 may be included in the SDS, but are not mandatory.

                Table D.1--Minimum Information for an SDS
------------------------------------------------------------------------
           Heading                             Subheading
------------------------------------------------------------------------
1. Identification............  (a) Product identifier used on the label;
                               (b) Other means of identification;
                               (c) Recommended use of the chemical and
                                restrictions on use;
                               (d) Name, address, and telephone number
                                of the chemical manufacturer, importer,
                                or other responsible party;
                               (e) Emergency phone number.
2. Hazard(s) identification..  (a) Classification of the chemical in
                                accordance with paragraph (d) of Sec.
                                1910.1200;
                               (b) Signal word, hazard statement(s),
                                symbol(s) and precautionary statement(s)
                                in accordance with paragraph (f) of Sec.
                                  1910.1200. (Hazard symbols may be
                                provided as graphical reproductions in
                                black and white or the name of the
                                symbol, e.g., flame, skull and
                                crossbones);
                               (c) Describe any hazards not otherwise
                                classified that have been identified
                                during the classification process;
                               (d) Where an ingredient with unknown
                                acute toxicity is used in a mixture at a
                                concentration >=1% and the mixture is
                                not classified based on testing of the
                                mixture as a whole, a statement that X%
                                of the mixture consists of ingredient(s)
                                of unknown acute toxicity is required.
3. Composition/information on  Except as provided for in paragraph (i)
 ingredients.                   of Sec.   1910.1200 on trade secrets:
                               For Substances
                               (a) Chemical name;
                               (b) Common name and synonyms;
                               (c) CAS number and other unique
                                identifiers;
                               (d) Impurities and stabilizing additives
                                which are themselves classified and
                                which contribute to the classification
                                of the substance.
                               For Mixtures
                               In addition to the information required
                                for substances:
                               (a) The chemical name and concentration
                                (exact percentage) or concentration
                                ranges of all ingredients which are
                                classified as health hazards in
                                accordance with paragraph (d) of Sec.
                                1910.1200 and
                               (1) Are present above their cut-off/
                                concentration limits; or
                               (2) Present a health risk below the cut-
                                off/concentration limits.
                               (b) The concentration (exact percentage)
                                shall be specified unless a trade secret
                                claim is made in accordance with
                                paragraph (i) of Sec.   1910.1200, when
                                there is batch-to-batch variability in
                                the production of a mixture, or for a
                                group of substantially similar mixtures
                                (See A.0.5.1.2) with similar chemical
                                composition. In these cases,
                                concentration ranges may be used.
                               For All Chemicals Where a Trade Secret is
                                Claimed
                               Where a trade secret is claimed in
                                accordance with paragraph (i) of Sec.
                                1910.1200, a statement that the specific
                                chemical identity and/or exact
                                percentage (concentration) 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
 protection.                    (PEL), American Conference of
                                Governmental Industrial Hygienists
                                (ACGIH) Threshold Limit Value (TLV), and
                                any other exposure limit used or
                                recommended by the chemical
                                manufacturer, importer, or employer
                                preparing the safety data sheet, where
                                available.
                               (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;

[[Page 17885]]

 
                               (k) Vapor pressure;
                               (l) Vapor density;
                               (m) Relative density;
                               (n) Solubility(ies);
                               (o) Partition coefficient: n-octanol/
                                water;
                               (p) Auto-ignition temperature;
                               (q) Decomposition temperature;
                               (r) Viscosity.
10. Stability and reactivity.  (a) Reactivity;
                               (b) Chemical stability;
                               (c) Possibility of hazardous reactions;
                               (d) Conditions to avoid (e.g., static
                                discharge, shock, or vibration);
                               (e) Incompatible materials;
                               (f) Hazardous decomposition products.
11. Toxicological information  Description of the various toxicological
                                (health) effects and the available data
                                used to identify those effects,
                                including:
                               (a) Information on the likely routes of
                                exposure (inhalation, ingestion, skin
                                and eye contact);
                               (b) Symptoms related to the physical,
                                chemical and toxicological
                                characteristics;
                               (c) Delayed and immediate effects and
                                also chronic effects from short- and
                                long-term exposure;
                               (d) Numerical measures of toxicity (such
                                as acute toxicity estimates).
                               (e) Whether the hazardous chemical is
                                listed in the National Toxicology
                                Program (NTP) Report on Carcinogens
                                (latest edition) or has been found to be
                                a potential carcinogen in the
                                International Agency for Research on
                                Cancer (IARC) Monographs (latest
                                edition), or by OSHA.
12. Ecological information     (a) Ecotoxicity (aquatic and terrestrial,
 (Non-mandatory).               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 under HCS (Sec.  1910.1200) are found in Appendix 
A.6 to this section. This non-mandatory Appendix provides additional 
guidance on hazard classification for carcinogenicity. Part A of 
Appendix F includes background guidance provided by GHS based on the 
Preamble of the International Agency for Research on Cancer (IARC) 
``Monographs on the Evaluation of Carcinogenic Risks to Humans'' 
(2006). Part B provides IARC classification information. Part C 
provides background guidance from the National Toxicology Program 
(NTP) ``Report on Carcinogens'' (RoC), and Part D is a table that 
compares GHS carcinogen hazard categories to carcinogen 
classifications under IARC and NTP, allowing classifiers to be able 
to use information from IARC and NTP RoC carcinogen classifications 
to complete their classifications under the GHS, and thus the HCS.

Part A: Background Guidance 1
---------------------------------------------------------------------------

    \1\ The text of Appendix F, Part A, on the IARC Monographs, is 
paraphrased from the 2006 Preamble to the ``Monographs on the 
Evaluation of Carcinogenic Risks to Humans''; the Classifier is 
referred to the full IARC Preamble for the complete text. The text 
is not part of the agreed GHS text on the harmonized system 
developed by the OECD Task Force-HCL.
---------------------------------------------------------------------------

    As noted in Footnote 6 of Appendix A.6. to this section, the GHS 
includes as guidance for classifiers information taken from the 
Preamble of the International Agency for Research on Cancer (IARC) 
``Monographs on the Evaluation of Carcinogenic Risks to Humans'' 
(2006), providing guidance on the evaluation of the strength and 
evidence of carcinogenic risks to humans. This guidance also 
discusses some additional considerations in classification and an 
approach to analysis, rather than hard-and-fast rules. Part A is 
consistent with Appendix A.6, and should help in evaluating 
information to determine carcinogenicity.
    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 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.
    (b) Limited evidence of carcinogenicity: A positive association 
has been observed between exposure to the agent 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:

[[Page 17886]]

    (a) Sufficient evidence of carcinogenicity: A causal 
relationship has been established between the agent and an increased 
incidence of malignant neoplasms or of an appropriate combination of 
benign and malignant neoplasms in two or more species of animals or 
two or more independent studies in one species carried out at 
different times or in different laboratories or under different 
protocols. An increased incidence of tumors in both sexes of a 
single species in a well-conducted study, ideally conducted under 
Good Laboratory Practices, can also provide sufficient evidence.
    Exceptionally, a single study in one species and sex 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 when there are 
strong findings of tumors at multiple sites.
    (a) Limited evidence of carcinogenicity: The data suggest a 
carcinogenic effect but are limited for making a definitive 
evaluation because, e.g. the evidence of carcinogenicity is 
restricted to a single experiment; there are unresolved questions 
regarding the adequacy of the design, conduct or interpretation of 
the studies; the agent increases the incidence only of benign 
neoplasms or lesions of uncertain neoplastic potential; or the 
evidence of carcinogenicity is restricted to studies that 
demonstrate only promoting activity in a narrow range of tissues or 
organs.

Guidance on How To Consider Important Factors in Classification of 
Carcinogenicity (See Reference Section)

    The weight of evidence analysis called for in GHS and the HCS 
(Sec.  1910.1200) is an integrative approach that 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), 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 
Preamble to the IARC Monographs (2006; Section B.6. (Scientific 
Review and Evaluation; Evaluation and Rationale)) provide a basis 
for systematic assessments that 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 above 
documents are not intended to dictate answers, nor provide lists of 
criteria to be checked off.

Mode of Action

    Various documents on carcinogen assessment all note that mode of 
action in and of itself, or consideration of comparative metabolism, 
should be evaluated on a case-by-case basis and are part of an 
analytic evaluative approach. One must look closely at any mode of 
action in animal experiments, taking into consideration comparative 
toxicokinetics/toxicodynamics between the animal test species and 
humans to determine the relevance of the results to humans. This may 
lead to the possibility of discounting very specific effects of 
certain types of substances. Life stage-dependent effects on 
cellular differentiation may also lead to qualitative differences 
between animals and humans. Only if a mode of action of tumor 
development is conclusively determined not to be operative in humans 
may the carcinogenic evidence for that tumor be discounted. However, 
a weight of evidence evaluation for a substance calls for any other 
tumorigenic activity to be evaluated, as well.

Responses in Multiple Animal Experiments

    Positive responses in several species add to the weight of 
evidence that a substance is a carcinogen. Taking into account all 
of the factors listed in A.6.2.5.2 and more, such chemicals with 
positive outcomes in two or more species would be provisionally 
considered to be classified in GHS Category 1B until human relevance 
of animal results are assessed in their entirety. It should be 
noted, however, that positive results for one species in at least 
two independent studies, or a single positive study showing 
unusually strong evidence of malignancy may also lead to Category 
1B.

Responses Are in One Sex or Both Sexes

    Any case of gender-specific tumors should be evaluated in light 
of the total tumorigenic response to the substance observed at other 
sites (multi-site responses or incidence above background) in 
determining the carcinogenic potential of the substance.
    If tumors are seen only in one sex of an animal species, the 
mode of action should be carefully evaluated to see if the response 
is consistent with the postulated mode of action. Effects seen only 
in one sex in a test species may be less convincing than effects 
seen in both sexes, unless there is a clear patho-physiological 
difference consistent with the mode of action to explain the single 
sex response.

Confounding Effects of Excessive Toxicity or Localized Effects

    Tumors occurring only at excessive doses associated with severe 
toxicity generally have doubtful potential for carcinogenicity in 
humans. In addition, tumors occurring only at sites of contact and/
or only at excessive doses need to be carefully evaluated for human 
relevance for carcinogenic hazard. For example, forestomach tumors, 
following administration by gavage of an irritating or corrosive, 
non-mutagenic chemical, may be of questionable relevance. However, 
such determinations must be evaluated carefully in justifying the 
carcinogenic potential for humans; any occurrence of other tumors at 
distant sites must also be considered.

Tumor Type, Reduced Tumor Latency

    Unusual tumor types or tumors occurring with reduced latency may 
add to the weight of evidence for the carcinogenic potential of a 
substance, even if the tumors are not statistically significant.
    Toxicokinetic behavior 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 \2\). Even when 
a particular tumor type may be discounted, expert judgment must be 
used in assessing the total tumor profile in any animal experiment.
---------------------------------------------------------------------------

    \2\ While most international agencies do not consider kidney 
tumors coincident with [alpha]2u-globulin nephropathy to be a 
predictor of risk in humans, this view is not universally held. 
(See: Doi et al., 2007).
---------------------------------------------------------------------------

Part B: International Agency for Research on Cancer (IARC) 3
---------------------------------------------------------------------------

    \3\ Preamble of the International Agency for Research on Cancer 
(IARC) ``Monographs on the Evaluation of Carcinogenic Risks to 
Humans'' (2006).
---------------------------------------------------------------------------

    IARC Carcinogen Classification Categories:
    Group 1: The agent is carcinogenic to humans
    This category is used when there is sufficient evidence of 
carcinogenicity in humans. Exceptionally, an agent may be placed in 
this category when evidence of carcinogenicity in humans is less 
than sufficient but there is sufficient evidence of carcinogenicity 
in experimental animals and strong evidence in exposed humans that 
the agent acts through a relevant mechanism of carcinogenicity.
    Group 2:
    This category includes agents for which, at one extreme, the 
degree of evidence of carcinogenicity in humans is almost 
sufficient, as well as those for which, at the other extreme, there 
are no human data but for which there is evidence of carcinogenicity 
in experimental animals. Agents are assigned to either Group 2A 
(probably carcinogenic to humans) or Group 2B (possibly carcinogenic 
to humans) on the basis of epidemiological and experimental evidence 
of carcinogenicity and mechanistic and other relevant data. The 
terms probably carcinogenic and possibly carcinogenic have no 
quantitative significance and are used simply as descriptors of 
different levels of evidence of human carcinogenicity, with probably 
carcinogenic signifying a higher level of evidence than possibly 
carcinogenic.
    Group 2A: The agent is probably carcinogenic to human.
    This category is used when there is limited evidence of 
carcinogenicity in humans and sufficient evidence of carcinogenicity 
in experimental animals. In some cases, an agent may be classified 
in this category when there is inadequate evidence of 
carcinogenicity in humans and sufficient evidence of carcinogenicity 
in experimental animals and strong evidence that the carcinogenesis 
is mediated by a mechanism that also operates in humans. 
Exceptionally, an agent may be classified in this category solely on 
the basis of limited evidence of carcinogenicity in humans. An agent 
may be assigned to this category if it clearly belongs, based on 
mechanistic considerations, to a class of agents for which one or 
more members have been classified in Group 1 or Group 2A.

[[Page 17887]]

    Group 2B: The agent is possibly carcinogenic to humans.
    This category is used for agents for which there is limited 
evidence of carcinogenicity in humans and less than sufficient 
evidence of carcinogenicity in experimental animals. It may also be 
used when there is inadequate evidence of carcinogenicity in humans 
but there is sufficient evidence of carcinogenicity in experimental 
animals. In some instances, an agent for which there is inadequate 
evidence of carcinogenicity in humans and less than sufficient 
evidence of carcinogenicity in experimental animals together with 
supporting evidence from mechanistic and other relevant data may be 
placed in this group. An agent may be classified in this category 
solely on the basis of strong evidence from mechanistic and other 
relevant data.

Part C: National Toxicology Program (NTP), ``Report on Carcinogens'', 
Background Guidance

NTP Listing Criteria \4\:
---------------------------------------------------------------------------

    \4\ See: http://ntp.niehs.nih.gov/go/15209.
---------------------------------------------------------------------------

    The criteria for listing an agent, substance, mixture, or 
exposure circumstance in the Report on Carcinogens (RoC) are as 
follows:
    Known To Be A Human Carcinogen: There is sufficient evidence of 
carcinogenicity from studies in humans \5\ that indicates a causal 
relationship between exposure to the agent, substance, or mixture, 
and human cancer.
---------------------------------------------------------------------------

    \5\ This evidence can include traditional cancer epidemiology 
studies, data from clinical studies, and/or data derived from the 
study of tissues or cells from humans exposed to the substance in 
question that can be useful for evaluating whether a relevant cancer 
mechanism is operating in people.
---------------------------------------------------------------------------

    Reasonably Anticipated To Be A Human Carcinogen: There is 
limited evidence of carcinogenicity from studies in humans that 
indicates that a causal interpretation is credible, but that 
alternative explanations, such as chance, bias, or confounding 
factors, could not adequately be excluded,

or

there is sufficient evidence of carcinogenicity from studies in 
experimental animals that indicates there is an increased incidence 
of malignant and/or a combination of malignant and benign tumors in 
multiple species or at multiple tissue sites, or by multiple routes 
of exposure, or to an unusual degree with regard to incidence, site, 
or type of tumor, or age at onset,

or

there is less than sufficient evidence of carcinogenicity in humans 
or laboratory animals; however, the agent, substance, or mixture 
belongs to a well-defined, structurally-related class of substances 
whose members are listed in a previous Report on Carcinogens as 
either known to be a human carcinogen or reasonably anticipated to 
be a human carcinogen, or there is convincing relevant information 
that the agent acts through mechanisms indicating it would likely 
cause cancer in humans.
    Conclusions regarding carcinogenicity in humans or experimental 
animals are based on scientific judgment, with consideration given 
to all relevant information. Relevant information includes, but is 
not limited to, dose response, route of exposure, chemical 
structure, metabolism, pharmacokinetics, sensitive sub-populations, 
genetic effects, or other data relating to mechanism of action or 
factors that may be unique to a given substance. For example, there 
may be substances for which there is evidence of carcinogenicity in 
laboratory animals, but there are compelling data indicating that 
the agent acts through mechanisms that do not operate in humans and 
would therefore not reasonably be anticipated to cause cancer in 
humans.

Part D: Table Relating Approximate Equivalences Among IARC, NTP RoC, 
and GHS Carcinogenicity Classifications

    The following table may be used to perform hazard 
classifications for carcinogenicity under the HCS (Sec.  1910.1200). 
It relates the approximated GHS hazard categories for 
carcinogenicity to the classifications provided by IARC and NTP, as 
described in Parts B and C of this Appendix.

                        Approximate Equivalences Among Carcinogen Classification Schemes
----------------------------------------------------------------------------------------------------------------
                  IARC                                GHS                               NTP RoC
----------------------------------------------------------------------------------------------------------------
Group 1.................................  Category 1A................  Known.
Group 2A................................  Category 1B................  Reasonably Anticipated.
Group 2B................................  Category 2.................  (See Note 1).
----------------------------------------------------------------------------------------------------------------
Note 1:
1. Limited evidence of carcinogenicity from studies in humans (corresponding to IARC 2A/GHS 1B);
2. Sufficient evidence of carcinogenicity from studies in experimental animals (again, essentially corresponding
  to IARC 2A/GHS 1B);
3. Less than sufficient evidence of carcinogenicity in humans or laboratory animals; however:
c. The agent, substance, or mixture belongs to a well-defined, structurally-related class of substances whose
  members are listed in a previous RoC as either ``Known'' or ``Reasonably Anticipated'' to be a human
  carcinogen, or
d. There is convincing relevant information that the agent acts through mechanisms indicating it would likely
  cause cancer in humans.

*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. Meek, 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. Toxicol. 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.
Cohen, S.M., 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.
Capen, C.C., 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.
Doi, A.M., G. Hill, J. Seely, J.R. Hailey, G. Kissling, and J.R. 
Buchera. 2007. [alpha]2u-Globulin nephropathy and renal tumors in 
National Toxicology Program studies. Toxicol. Pathol. 35:533-540.
* * * * *

0
33. Amend Sec.  1910.1450 as follows:
0
A. Remove the definitions of Combustible liquid, Compressed gas, 
Explosive, Flammable, Flashpoint, Organic peroxide, Oxidizer, Unstable 
(reactive), and Water-reactive from paragraph (b);
0
B. Revise the definitions of Hazardous chemical, Physical hazard, and 
Reproductive toxins in paragraph (b);
0
C. Add definitions of Health hazard and Mutagen in alphabetical order 
in paragraph (b);

[[Page 17888]]

0
D. In paragraphs (f)(3)(v), (h)(1) introductory text, (h)(1)(ii) and 
(h)(2)(iii), remove the phrases ``Material Safety Data Sheets'' and 
``material safety data sheets'' and add in their place ``safety data 
sheets'';
0
E. In Appendix A to Sec.  1910.1450, in the Table of Contents (item 
``G'') remove ``Material Safety Data Sheets'' and add in its place 
``Safety Data Sheets'';
0
F. In Appendix A to Sec.  1910.1450, revise the heading ``G. Material 
Safety Data Sheets'' and revise the text following the heading.
    The revisions read as follows:


Sec.  1910.1450  Occupational exposure to hazardous chemicals in 
laboratories.

* * * * *
    (b) * * *
    Hazardous chemical means any chemical which is classified as health 
hazard or simple asphyxiant in accordance with the Hazard Communication 
Standard (Sec.  1910.1200).
    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); 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 (Sec.  
1910.1200) and Sec.  1910.1200(c) (definition of ``simple 
asphyxiant'').
* * * * *
    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 (Sec.  
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 (gas, liquid or solid); self-heating; organic 
peroxide; corrosive to metal; gas under pressure; in contact with water 
emits flammable gas; or combustible dust. The criteria for determining 
whether a chemical is classified as a physical hazard are in Appendix B 
of the Hazard Communication Standard (Sec.  1910.1200) and Sec.  
1910.1200(c) (definitions of ``combustible dust'' and ``pyrophoric 
gas'').
* * * * *
    Reproductive toxins mean 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 (Sec.  
1910.1200) shall be considered reproductive toxins for purposes of this 
section.
* * * * *

Appendix A to Sec.  1910.1450--National Research Council 
Recommendations Concerning Chemical Hygiene in Laboratories (Non-
Mandatory)

* * * * *
G. Safety Data Sheets
    Safety data sheets are presented in ``Prudent Practices'' for the 
chemicals listed below. (Asterisks denote that comprehensive safety 
data sheets are provided).
* * * * *

PART 1915--OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD 
EMPLOYMENT

0
34. 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), 5-2007 (72 FR 31160), 4-
2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; 29 CFR 
Part 1911.
    Section 1915.100 also issued under 49 U.S.C. 1801-1819 and 5 
U.S.C. 553.
    Sections 1915.120 and 1915.152 of 29 CFR also issued under 29 
CFR part 1911.

Subpart Z--[Amended]

0
35. Revise Sec.  1915.1001 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) 
(Sec.  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) Labels. (A) 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 BREATHE DUST
AVOID CREATING DUST

    (B)(1) Prior to June 1, 2015, employers may include the following 
information on raw materials, mixtures or labels of bags or containers 
of protective clothing and equipment, scrap, waste, and debris 
containing asbestos fibers in lieu of the labeling requirements in 
paragraphs (k)(7)(ii) and (k)(7)(iii)(A) of this section:

DANGER
CONTAINS ASBESTOS FIBERS
AVOID CREATING DUST
CANCER AND LUNG DISEASE HAZARD

    (2) Labels shall also contain a warning statement against breathing 
asbestos fibers.
    (iv) The provisions for labels required in paragraph (k)(7) of this 
section 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

[[Page 17889]]

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 (k)(8) 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 paragraph (k)(8) of this section. 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.
    (vi) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (k)(8)(ii) of this section:

DANGER
ASBESTOS
CANCER AND LUNG DISEASE HAZARD
AUTHORIZED PERSONNEL ONLY

    (vii) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (k)(8)(iii) of this section:

RESPIRATORS AND PROTECTIVE CLOTHING ARE REQUIRED IN THIS AREA

* * * * *

0
36. Revise Sec.  1915.1026 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, Sec.  1910.1200.
* * * * *
    (j) * * *
    (1) Hazard communication. The employer shall include chromium (VI) 
in the program established to comply with the Hazard Communication 
Standard (HCS) (Sec.  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]

0
37. 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), 5-2007 (72 FR 
31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912) 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 1926.61 also issued under 49 U.S.C. 1801-1819 and 6 
U.S.C. 553.
    Section 1926.62 also issued under section 1031 of the Housing 
and Community Development Act of 1992 (42 U.S.C. 4853).
    Section 1926.65 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.


0
38. Revise Sec.  1926.60 paragraphs (l)(1) and (l)(2) to read as 
follows:


Sec.  1926.60  Methylenedianiline.

* * * * *
    (l) * * *
    (1) Hazard communication. The employer shall include 
Methylenedianiline (MDA) in the program established to comply with the 
Hazard Communication Standard (HCS) (Sec.  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) Signs and labels-- (i) Signs. (A) 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

    (B) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (l)(2)(i)(A) of this section:

DANGER
MDA
MAY CAUSE CANCER
LIVER TOXIN
AUTHORIZED PERSONNEL ONLY
RESPIRATORS AND PROTECTIVE CLOTHING MAY BE REQUIRED TO BE WORN IN 
THIS AREA

    (ii) Labels. (A) The employer shall ensure that labels or other 
appropriate forms of warning are provided for containers of MDA within 
the workplace. The labels shall comply with the requirements of Sec.  
1910.1200(f) and shall include at least the following information for 
pure MDA and mixtures containing MDA:

DANGER
CONTAINS MDA
MAY CAUSE CANCER
CAUSES DAMAGE TO THE LIVER

    (B) Prior to June 1, 2015, employers may include the following 
information workplace labels in lieu of the labeling requirements in 
paragraph (l)(2)(ii)(A) of this section:
    (1) For Pure MDA:

DANGER
CONTAINS MDA
MAY CAUSE CANCER
LIVER TOXIN

    (2) For mixtures containing MDA:

DANGER
CONTAINS MDA
CONTAINS MATERIALS WHICH MAY CAUSE CANCER

[[Page 17890]]

LIVER TOXIN
* * * * *

0
39. Amend Sec.  1926.62 by revising paragraph (g)(2)(vii), the heading 
of paragraph (l), paragraph (l)(1)(i), and paragraph (m), and Appendix 
B to Sec.  1926.62 section XI, to read as follows:


Sec.  1926.62  Lead.

* * * * *
    (g) * * *
    (2) * * *
    (vii)(A) 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. DISPOSE OF LEAD CONTAMINATED WASH WATER IN 
ACCORDANCE WITH APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.

    (B) Prior to June 1, 2015, employers may include the following 
information on bags or containers of contaminated protective clothing 
and equipment required by paragraph (g)(2)(v) in lieu of the labeling 
requirements in paragraph (g)(2)(vii)(A) of this section:

Caution: Clothing contaminated with lead. Do not remove dust by 
blowing or shaking. Dispose of lead contaminated wash water in 
accordance with applicable local, state, or federal regulations.
* * * * *
    (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) (Sec.  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) 
of this section. The employer shall ensure that at least the following 
hazards are addressed:
    (A) Reproductive/developmental toxicity;
    (B) Central nervous system effects;
    (C) Kidney effects;
    (D) Blood effects; and
    (E) Acute toxicity effects.
* * * * *
    (m) Signs.
    (1) General.
    (i) The employer shall post the following warning signs in each 
work area where an employee's exposure to lead is above the PEL.

DANGER
LEAD WORK AREA
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 (m) that contradicts or detracts 
from the meaning of the required sign.
    (iii) The employer shall ensure that signs required by this 
paragraph (m) 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 (m).
    (v) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (m)(1)(i) of this section:

WARNING
LEAD WORK AREA
POISON
NO SMOKING OR EATING
* * * * *

Appendix B to Sec.  1926.62--Employee Standard Summary

* * * * *

XI. Signs--Paragraph (M)

    The standard requires that the following warning sign be posted 
in work areas when the exposure to lead is above the PEL:

DANGER
LEAD WORK AREA
MAY DAMAGE FERTILITY OR THE UNBORN CHILD
CAUSES DAMAGE TO THE CENTRAL NERVOUS SYSTEM
DO NOT EAT, DRINK OR SMOKE IN THIS AREA

    Prior to June 1, 2016, employers may use the following legend in 
lieu of that specified above:

WARNING
LEAD WORK AREA
POISON
NO SMOKING OR EATING
* * * * *

0
40. Revise Sec.  1926.64 paragraphs (a)(1)(ii) introductory text, 
(a)(1)(ii)(B), and (d)(1)(vii), and the note following paragraph 
(d)(1)(vii), 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 Sec.  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.
* * * * *
    (d) * * *
    (1) * * *
    (vii) Hazardous effects of inadvertent mixing of different 
materials that could foreseeably occur.

    Note to paragraph (d)(1): Safety data sheets meeting the 
requirements of Sec.  1910.1200(g) may be used to comply with this 
requirement to the extent they contain the information required by 
this paragraph (d)(1).

* * * * *

0
41. Amend Sec.  1926.65 paragraph (a)(3) by revising 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, Sec.  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; specific target organ toxicity (single or repeated exposure); 
aspiration toxicity or simple asphyxiant. (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.)
* * * * *

Subpart F--[Amended]

0
42. Revise the authority citation for subpart F 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, 
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), 5-2007 (72 FR 31159), 4-
2010 (75 FR 55355), or 1-2012

[[Page 17891]]

(77 FR 3912), as applicable; and 29 CFR part 1911.
* * * * *

0
43. Amend Sec.  1926.152 as follows:
0
A. Revise the section heading;
0
B. Remove the words ``and combustible'' from the first sentence in 
paragraph (a)(1), the heading of paragraph (b), and paragraphs (b)(2) 
introductory text, (b)(4)(viii), (h) introductory text, and (h)(1);
0
C. Remove the words ``or combustible'' wherever it appears in 
paragraphs (a)(2), (b)(1), (b)(4)(iii), (b)(5), and (c)(3);
0
D. Remove the words ``or combustible'' in paragraphs (d) (the heading), 
(d)(1), (d)(4), (e)(1), (e)(3), (f)(2), (g)(1), and (g)(8);
0
E. Remove the words ``or combustible'' wherever it appears in 
paragraphs (i)(1)(i)(D) and (F), (i)(1)(iii)(D), (i)(2)(ii)(A), (D), 
and (F), (i)(2)(vii)(B)(2), (i)(4)(iv)(C), (i)(5)(vi)(A), (D), (G), (V) 
introductory text, and (i)(5)(vi)(V)(1); (j)(1)(i), (j)(2)(ii), (j)(5), 
and (k)(4);
0
F. Amend the fifth sentence of paragraph (b)(4)(vi) by adding the words 
``Category 1, 2, or 3'' before the words ``flammable liquids'';
0
G. Amend paragraphs (e)(2), (e)(5), (g)(7)(i), and (g)(7)(ii), by 
adding the words ``Category 1, 2, or 3'' before the words ``flammable 
liquids'' ;
0
H. Amend paragraphs (f)(1) and (f)(3) by removing the words ``Flammable 
liquids'' and adding in their place the words ``Category 1, 2, or 3 
flammable liquids'';
0
I. Revise paragraphs (b)(2)(iii), (b)(3), (h) introductory text, 
(i)(2)(iv)(F) and (G), (i)(2)(vi)(B), (i)(2)(viii)(E), (i)(3)(i), 
(i)(3)(iv)(A) and (C), (i)(3)(v)(D), and (i)(4)(iv)(E);
0
J. Revise Table F-19 and paragraph (k)(3)(iv).
    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/or 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: Tanks of 3,000 bbls (barrels) (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 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.
* * * * *
    (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

[[Page 17892]]

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) * * *
    (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) * * *
* * * * *
BILLING CODE 4510-26-P

[[Page 17893]]

[GRAPHIC] [TIFF OMITTED] TR26MR12.128


[[Page 17894]]


[GRAPHIC] [TIFF OMITTED] TR26MR12.129

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.
* * * * *

0
44. Amend Sec.  1926.155 as follows:
0
A. Remove and reserve paragraph (c);
0
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 (37.8 
[deg]C) and having a flashpoint at or below 199.4 [deg]F (93 [deg]C). 
Flammable liquids are divided into four categories as follows:
    (1) 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).
    (2) 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).
    (3) 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).
    (4) 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 (incorporated by reference; See Sec.  
1926.6), or an equivalent method as defined by Sec.  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 (incorporated 
by reference; See Sec.  1926.6), or an equivalent method as defined by 
Sec.  1910.1200 appendix B.
* * * * *

Subpart Z--[Amended]

0
45. Revise the authority citation for subpart Z to read as follows:

    Authority: Section107 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, 
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), 5-2007 (72 FR 
31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912) as applicable; 
and 29 CFR part 1911.


[[Page 17895]]


    Section 1926.1102 not issued under 29 U.S.C. 655 or 29 CFR part 
1911; also issued under 5 U.S.C. 553.

0
46. Amend Sec.  1926.1101 as follows:
0
A. Redesignate paragraph (k)(1) as (k)(1)(i) and add a new heading to 
paragraph (k)(1);
0
B. Add new paragraphs (k)(1)(ii), (k)(7)(ii)(C), (k)(7)(ii)(D), and 
(k)(8)(iv);
0
C. Amend paragraphs (k)(2)(i) and (k)(3)(i) by removing the references 
to ``(k)(1)'' and adding in their place ``(k)(1)(i)'';
0
D. Revise paragraphs (k)(7)(ii)(A) and (B), and (k)(8)(ii) and (iii);
    The 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) (Sec.  
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

    (C) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (k)(7)(ii)(A) of this section:

DANGER
ASBESTOS
CANCER AND LUNG DISEASE HAZARD
AUTHORIZED PERSONNEL ONLY

    (D) Prior to June 1, 2016, employers may use the following legend 
in lieu of that specified in paragraph (k)(7)(ii)(B) of this section:

RESPIRATORS AND PROTECTIVE CLOTHING ARE REQUIRED IN THIS AREA

* * * * *
    (8) * * *
    (ii) The employer shall ensure that such labels comply with 
paragraphs (k) of this section.
    (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 BREATHE DUST
AVOID CREATING DUST

    (iv) (A) Prior to June 1, 2015, employers may include the following 
information on raw materials, mixtures or labels of bags or containers 
of protective clothing and equipment, scrap, waste, and debris 
containing asbestos fibers in lieu of the labeling requirements in 
paragraphs (k)(8)(ii) and (k)(8)(iii) of this section:

DANGER
CONTAINS ASBESTOS FIBERS
AVOID CREATING DUST
CANCER AND LUNG DISEASE HAZARD

    (B) Labels shall also contain a warning statement against breathing 
asbestos fibers.
* * * * *

0
47. Revise Sec.  1926.1126 paragraphs (g)(2)(iv) and (j)(1) to read as 
follows:


Sec.  1926.1126  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 shall 
be labeled in accordance with the requirements of the Hazard 
Communication Standard, Sec.  1910.1200.
* * * * *
    (j) * * *
    (1) Hazard communication. The employer shall include chromium (VI) 
in the program established to comply with the Hazard Communication 
Standard (HCS) (Sec.  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 Sec.  
1910.1200 and paragraph (j)(2) of this section. The employer shall 
provide information on at least the following hazards: Cancer; eye 
irritation; and skin sensitization.
* * * * *

0
48. Revise Sec.  1926.1127 paragraphs (i)(2)(iv), (k)(7), and (m)(1), 
(m)(2), and (m)(3), to read as follows:


Sec.  1926.1127  Cadmium.

* * * * *
    (i) * * *
    (2) * * *
    (iv) The employer shall ensure that 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 shall bear labels in accordance with paragraph (m)(3)(ii) of 
this section.
    (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 (m)(3)(ii) of this 
section.
* * * * *
    (m) * * *
    (1) Hazard communication. The employer shall include cadmium in the 
program established to comply with the Hazard Communication Standard 
(HCS) (Sec.  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) Warning signs. (i) Warning signs shall be provided and 
displayed in regulated areas. 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) 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

    (iii) The employer shall ensure that signs required by this 
paragraph (m)(2) are illuminated, cleaned, and maintained as necessary 
so that the legend is readily visible.
    (iv) Prior to June 1, 2016, employers may use the following legend 
in lieu of

[[Page 17896]]

that specified in paragraph (m)(2)(ii) of this section:

DANGER
CADMIUM
CANCER HAZARD
CAN CAUSE LUNG AND KIDNEY DISEASE
AUTHORIZED PERSONNEL ONLY
RESPIRATORS REQUIRED IN THIS AREA

    (3) Warning labels. (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 containers of cadmium-contaminated 
protective clothing, equipment, waste, scrap, or debris shall include 
at least the following information:

DANGER
CONTAINS CADMIUM
MAY CAUSE CANCER
CAUSES DAMAGE TO LUNGS AND KIDNEYS
AVOID CREATING DUST

    (iii) Where feasible, installed cadmium products shall have a 
visible label or other indication that cadmium is present.
    (iv) Prior to June 1, 2015, employers may include the following 
information on shipping and storage containers containing cadmium, 
cadmium compounds, or cadmium-contaminated clothing, equipment, waste, 
scrap, or debris in lieu of the labeling requirements specified in 
paragraphs (m)(3)(i) and (m)(3)(ii) of this section:

DANGER
CONTAINS CADMIUM
CANCER HAZARD
AVOID CREATING DUST
CAN CAUSE LUNG AND KIDNEY DISEASE
* * * * *
[FR Doc. 2012-4826 Filed 3-20-12; 11:15 am]
BILLING CODE 4510-26-P