[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]
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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
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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.
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\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\
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\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.
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\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.
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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.
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\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.
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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\
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\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\
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\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]]
[GRAPHIC] [TIFF OMITTED] TR26MR12.003
[[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