Hazard Communication, 53617-53627 [06-7584]
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Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Proposed Rules
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Parts 1910, 1915, 1917, 1918,
and 1926
[Docket No. H–022K]
RIN 1218–AC20
Hazard Communication
Occupational Safety and Health
Administration (OSHA), Department of
Labor.
ACTION: Advance Notice of Proposed
Rulemaking (ANPRM).
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AGENCY:
SUMMARY: OSHA, other Federal
agencies, and stakeholder
representatives have participated in
long-term international negotiations to
develop a Globally Harmonized System
of Classification and Labeling of
Chemicals (GHS). The GHS has been
adopted by the United Nations, and
there is an international goal for as
many countries as possible to
implement the GHS by 2008. The GHS
includes harmonized provisions for
classification of chemicals for their
health, physical, and environmental
effects, as well as for labels on
containers and safety data sheets (SDS).
Adoption of the GHS by OSHA would
require modifications to the Agency’s
Hazard Communication Standard (HCS).
For example, an order of information
would be established for safety data
sheets. In this notice, OSHA is
providing further information about the
GHS, the benefits of adopting it, and its
potential impact on the HCS. OSHA is
seeking input from the public on a
number of issues related to
implementation of the GHS. The Agency
is simultaneously announcing the
availability of a new guide on its Web
site at https://www.osha.gov that
describes the GHS.
DATES: Comments must be submitted by
the following dates:
Hard copy: Your comments must be
submitted (postmarked or sent) by
November 13, 2006.
Facsimile and electronic
transmission: Your comments must be
sent by November 13, 2006.
ADDRESSES: You may submit comments,
identified by OSHA Docket No. H–
022K, by any of the following methods:
Federal eRulemaking Portal: https://
www.regulations.gov Follow the
instructions below for submitting
comments.
Agency Web Site: https://
ecomments.osha.gov Follow the
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instructions on the OSHA web page for
submitting comments.
FAX: If your comments, including any
attachments, are 10 pages or fewer, you
may fax them to the OSHA Docket
Office at (202) 693–1648.
Mail, express delivery, hand delivery,
and courier service: You must submit
three copies of your comments and
attachments to the OSHA Docket Office,
Docket No. H–022K, Room N2625, U.S.
Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210;
telephone (202) 693–2350 (OSHA’s TTY
number is (877) 889–5627). OSHA
Docket Office and Department of Labor
hours of operation are 8:15 a.m. to 4:45
p.m., ET.
Instructions: All submissions received
must include the Agency name and
docket number (H–022K). Comments
received will be posted without change
on OSHA’s Web page at https://
www.osha.gov, including any personal
information provided. For detailed
instructions on submitting comments,
see the ‘‘Public Participation’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read comments or background
documents received, go to OSHA’s Web
page. Comments and submissions are
also available for inspection and
copying at the OSHA Docket Office at
the address above.
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Kevin Ropp, OSHA
Office of Communications, Room
N3647, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington,
DC 20210; telephone (202) 693–1999.
General and technical information:
Maureen O’Donnell, Industrial
Hygienist, or David O’Connor, Health
Scientist, Directorate of Standards and
Guidance, Room N3718, U.S.
Department of Labor, 200 Constitution
Avenue, NW., Washington, DC 20210;
telephone (202) 693–1950.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. History of the OSHA Hazard
Communication Standard
B. OSHA’s Involvement in Development of
the GHS
C. Other OSHA Activities Related to the
GHS
D. Benefits of the GHS
E. State Plan States
II. Provisions of OSHA’s HCS and the GHS
A. Scope of the GHS
B. Definitions of Hazards Covered
C. Health Hazards
D. Physical Hazards
E. Labels
F. Safety Data Sheets
III. Public Resources for Further Information
on the GHS
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IV. Request for Input
V. Public Participation
VI. Authority and Signature
I. Background
A. History of the OSHA Hazard
Communication Standard
OSHA’s Hazard Communication
Standard (HCS) (29 CFR 1910.1200;
1915.1200; 1917.28; 1918.90; and
1926.59) was first adopted in 1983 for
the manufacturing sector of industry (48
FR 53280; November 25, 1983). Later,
the Agency expanded the scope of
coverage to all industries where
employees are potentially exposed to
hazardous chemicals (52 FR 31852;
August 24, 1987). The HCS requires
chemical manufacturers and importers
to evaluate the hazards of the chemicals
they produce or import. The rule
provides definitions of health and
physical hazards to use as the criteria
for determining hazards in the
evaluation process. The information
about the hazards and protective
measures is then required to be
conveyed to downstream employers and
employees by putting labels on
containers and preparing and
distributing safety data sheets. All
employers with hazardous chemicals in
their workplaces are required to have a
hazard communication program,
including container labels, safety data
sheets, and employee training. (Note:
The HCS uses the term ‘‘material safety
data sheet’’ or MSDS, while the GHS
uses safety data sheet or SDS. For
convenience, safety data sheet or SDS is
being used throughout this document.)
OSHA has updated estimates in the
standard’s regulatory impact analysis,
and found that the HCS now covers over
7 million workplaces, more than 100
million employees, and some 945,000
hazardous chemical products. Ensuring
that hazard and protective measure
information is available in workplaces
through hazard communication
programs helps employers design and
implement appropriate controls for
chemical exposures, and gives
employees the right-to-know the
hazards and identities of the chemicals,
as well as allowing them to participate
actively in the successful control of
exposures. Together, these actions of
employers and employees reduce the
potential for adverse effects to occur.
The information transmitted under the
HCS requirements provides the
foundation upon which a chemical
safety and health program can be built
in the workplace.
The HCS is performance-oriented, i.e.,
it establishes requirements for labels
and safety data sheets but does not
provide the specific language to convey
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the information or a format in which to
provide it.
B. OSHA Involvement in the
Development of the GHS
OSHA’s HCS is designed to
disseminate information on chemicals
to users to precipitate changes in
handling methods and thus protect
those exposed to the chemical from
experiencing adverse effects. Since the
United States (U.S.) is both a major
importer and exporter of chemicals, the
manner in which the U.S. and other
countries choose to regulate information
dissemination on hazardous chemicals
not only has an impact on the protection
of employees in the U.S. but also may
pose potential barriers to international
trade in chemicals.
To protect employees and members of
the public who are potentially exposed
to chemicals during their production,
transportation, use, and disposal, a
number of countries have developed
laws that require information about
those chemicals to be prepared and
transmitted to affected parties. These
laws vary with regard to the scope of
chemicals covered, definitions of
hazards, the specificity of requirements
(e.g., specification of a format for safety
data sheets), and the use of symbols and
pictograms. The inconsistencies
between the various laws are substantial
enough that different labels and safety
data sheets must often be developed for
the same product when it is marketed in
different nations. For example, Canada
has established requirements for labels
under its Workplace Hazardous
Materials Information System (WHMIS).
WHMIS requires that labels include
specified symbols within a defined
circle. U.S. chemical manufacturers
must label chemicals accordingly for
marketing in Canada.
Within the U.S., several regulatory
authorities exercise jurisdiction over
chemical hazard communication. In
addition to OSHA’s HCS, the
Department of Transportation (DOT)
regulates chemicals in transport, the
Consumer Product Safety Commission
(CPSC) regulates consumer products,
and the Environmental Protection
Agency (EPA) regulates pesticides, as
well as having other authority over
labeling under the Toxic Substances
Control Act. Each of these regulatory
authorities operates under different
statutory mandates, and have adopted
varying approaches to hazard
communication requirements.
The diverse and sometimes
conflicting national and international
requirements can create confusion
among those who seek to use hazard
information effectively. For example,
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labels and safety data sheets may
include symbols and hazard statements
that are unfamiliar to readers or not well
understood. Containers may be labeled
with such a large volume of information
that important statements are not easily
recognized. Given the differences in
hazard classification criteria, labels may
also be incorrect when used in other
countries. This is particularly true with
regard to workplace hazard
communication in the U.S. Since the
U.S. OSHA system is performanceoriented, labels meeting the
specification requirements of other
countries are often seen in the U.S.
workplace. While there are no format
requirements in the U.S. that are
violated by these differing formats, the
underlying hazard criteria from another
country may be different and that could
make the information on the labels out
of compliance with the U.S. HCS.
Development of multiple sets of labels
and safety data sheets for each product
when shipped to different countries is a
major compliance burden for chemical
manufacturers, distributors, and
transporters involved in international
trade. Small businesses may have
particular difficulty in coping with the
complexities and costs involved.
When the HCS was first issued in
1983, the preamble included a
commitment by OSHA to review the
standard regularly to address
international harmonization of hazard
communication requirements. OSHA
was asked to include this commitment
in the final rule in recognition of an
interagency trade policy that supported
the U.S. pursuing international
harmonization of requirements for
chemical classification and labeling.
The potential benefits of harmonization
were noted in the preamble:
* * * [O]SHA acknowledges the long-term
benefit of maximum recognition of hazard
warnings, especially in the case of containers
leaving the workplace which go into
interstate and international commerce. The
development of internationally agreed
standards would make possible the broadest
recognition of the identified hazards while
avoiding the creation of technical barriers to
trade and reducing the costs of dissemination
of hazard information by elimination of
duplicative requirements which could
otherwise apply to a chemical in commerce.
As noted previously, these regulations will
be reviewed on a regular basis with regard to
similar requirements which may be evolving
in the United States and in foreign countries.
(48 FR 53287; November 25, 1983)
OSHA was the only Federal agency
that had a public commitment to pursue
harmonization. We have actively
participated in a number of such efforts
in the years since that commitment was
made, including participation in trade-
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related discussions on the need for
harmonization with major U.S. trading
partners. The Agency also issued a
Request for Information (RFI) in the
Federal Register in January 1990, to
obtain input regarding international
harmonization efforts, and on work
being done at that time to develop a
convention and recommendation on
safety in the use of chemicals at work
in the International Labor Organization
(55 FR 2166).
Little progress was made regarding
international harmonization until June
1992, when a mandate from the United
Nations Conference on Environment
and Development (UNCED) (Chapter 19
of Agenda 21), supported by the U.S.,
called for development of a globally
harmonized chemical classification and
labeling system:
A globally harmonized hazard
classification and compatible labelling
system, including material safety data sheets
and easily understandable symbols, should
be available, if feasible, by the year 2000.
UNCED further noted that an
internationally harmonized system for
transport of dangerous goods was
already available. However:
* * * [G]lobally harmonized hazard
classification and labelling systems are not
yet available to promote the safe use of
chemicals, inter alia, at the workplace or in
the home. Classification of chemicals can be
made for different purposes and is a
particularly important tool in establishing
labelling systems. There is a need to develop
harmonized hazard classification and
labelling systems, building on ongoing work.
This international mandate initiated
an extensive effort to develop the GHS.
It involved numerous international
organizations, many countries, and
extensive stakeholder representation.
The work was managed by the
Coordinating Group on the
Harmonization of Chemical
Classification Systems, under the
umbrella of the Interorganization
Programme for the Sound Management
of Chemicals. OSHA chaired the
international coordinating group that
managed the harmonization work. The
technical work was divided among
several international organizations.
Development of criteria for health and
environmental hazards, as well as
mixture classification for chemicals
having these hazards, was done under
the auspices of the Organization for
Economic Cooperation and
Development (OECD). Criteria for
physical hazards were based on the
already harmonized criteria for
transportation, and developed by the
United Nations Subcommittee of
Experts on the Transport of Dangerous
Goods and the International Labor
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Organization. The overall management
of the process, as well as the work on
aspects of the system for communicating
hazards on labels and safety data sheets,
were done by the International Labor
Organization. OSHA participated in all
of this work, and took the U.S. lead on
classification of mixtures and hazard
communication.
The negotiations were extensive and
spanned a number of years. The primary
approach involved identifying the
relevant provisions in each of the major
existing systems, developing
background documents that compared,
contrasted, and explained the rationale
for such provisions, and undertaking
negotiations to find an agreed approach
that addressed the needs of the
countries and stakeholders involved.
The major existing systems were those
of the U.S., Canada, and Europe, and the
United Nations Recommendations for
the Transport of Dangerous Goods.
Principles to guide the work were
established, including an agreement that
protections of the existing systems were
not to be reduced as a result of
harmonization. Thus countries could be
assured that the existing protections of
their longstanding systems would be
maintained or enhanced in the resulting
harmonized approach.
In the U.S., an interagency committee
under the auspices of the U.S.
Department of State coordinated the
various agencies involved. In addition
to the four core agencies that have
requirements that are potentially
impacted by the GHS, there were a
number of other agencies involved that
had interests related to trade or other
aspects of the GHS process. Different
agencies had the lead in various parts of
the discussions. Positions for the U.S. in
these negotiations were coordinated
through the interagency committee.
Interested stakeholders were kept
informed through e-mail dissemination
of information, as well as periodic
public meetings. The U.S. Department
of State also published a notice in the
Federal Register that described the
harmonization activities, the agencies
involved, the principles of
harmonization, and other information,
as well as invited public comment on
these issues (62 FR 15951; April 3,
1997). Stakeholders also actively
participated themselves in the
discussions in the international
organizations and were able to present
their views directly in the negotiating
process.
The product resulting from this effort,
the Globally Harmonized System of
Classification and Labeling of Chemicals
(GHS), was formally adopted by the new
United Nations Committee of Experts on
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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. While the GHS has
been adopted, it is considered to be a
living document that will be updated as
necessary to reflect new technology and
scientific developments, or provide
additional explanatory text. OSHA
expects to propose adoption of the 2005
version, Revision 1. Modifications to the
GHS that are made after the GHS is
adopted in the U.S. would require
additional rulemaking.
It should be noted that the GHS
document consists of non-mandatory
recommendations and explanatory text.
It is not a model regulation or a standard
that is to be adopted verbatim. Countries
like the U.S., and agencies such as
OSHA, will propose converting the
recommendations into appropriate
regulatory text consistent with national
requirements while ensuring that the
specific provisions are consistent with
the GHS and thus harmonized. OSHA
expects to propose modifying the HCS
to address the changes in hazard
criteria, adopt the specific labeling
requirements, and adopt the SDS order
of information. Other parts of the
framework of the HCS (such as the
coverage of articles, trade secrets, and
scope) would likely remain the same.
While the GHS text is available to
everyone on the UN Web site, it will be
the proposed rule to adopt the GHS that
OSHA plans to issue rather than the
detailed GHS document that will be of
primary interest to U.S. stakeholders. To
help those who are not familiar with the
approach in the GHS, OSHA has
prepared a guide that summarizes the
GHS requirements, and it is available on
our Web site (click on the Hazard
Communication button on https://
www.osha.gov). In addition, the Agency
also has a detailed comparison of the
HCS to the GHS available on the Web
site so that interested parties can review
the types of changes that would need to
be made for the current U.S. workplace
requirements to be harmonized with the
international approach.
A review of these differences reveals
that the primary impact of revising the
HCS to adopt the GHS would be on
compliance obligations for producers of
hazardous chemicals. The modifications
to the HCS would involve a review of
the classifications of these chemicals, as
well as preparation and distribution of
new labels and revised safety data
sheets. Employers who use chemicals,
and exposed employees, would benefit
from receiving the revised labels and
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safety data sheets prepared in a
consistent format. The information
should be easier to comprehend and
access in the new approach, allowing it
to be used more effectively for the
protection of employees. The primary
change in workplaces where chemicals
are used but not produced will be to
integrate the new approach into the
workplace hazard communication
program, including assuring that both
the employers and employees
understand the pictograms and other
information provided on the chemicals.
The GHS is now available for
worldwide implementation, and
countries have been encouraged to
implement the GHS as soon as possible,
with the goal of a fully operational
system by 2008. This goal was adopted
by countries in the Intergovernmental
Forum on Chemical Safety, as well as
endorsed by the World Summit on
Sustainable Development. In addition,
countries involved in the Asia-Pacific
Economic Cooperation have endorsed a
goal of 2006. The U.S. participates in all
of these international groups, and has
agreed to working toward achieving
these goals.
The U.S. is also a member of both the
United Nations Committee of Experts on
the Transport of Dangerous Goods and
the Globally Harmonized System of
Classification and Labeling of
Chemicals, as well as the Subcommittee
of Experts on the Globally Harmonized
System of Classification and Labeling of
Chemicals. These permanent UN bodies
have international responsibility for
maintaining, updating as necessary, and
overseeing the implementation of the
GHS. OSHA and other affected Federal
agencies actively participate in these
UN groups. In addition, OSHA, EPA and
the U.S. State Department also
participate in the GHS Programme
Advisory Group that functions under
the United Nations Institute for Training
and Research (UNITAR). UNITAR is
responsible internationally 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 interested
nations.
C. Other OSHA Activities Related to the
GHS
OSHA and the other three core
agencies continue interagency
discussions related to coordination of
domestic implementation of the GHS, in
addition to ongoing discussions and
coordination related to international
work to implement and maintain the
GHS.
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OSHA also has ongoing activities
related to the GHS under the North
American Free Trade Agreement
(NAFTA) discussions on handling of
hazardous substances, and in
discussions with the European Union
on issues related to the global
management of chemicals.
In addition, a number of organizations
with whom OSHA has Alliances have
expressed an interest in hazard
communication, and in working
together with each other on the subject.
The Alliance program is a cooperative
program that enables organizations
committed to occupational safety and
health to work with OSHA to prevent
injuries, illnesses, and fatalities in the
workplace (click on the Alliances button
on OSHA’s home page for an
explanation of the program and a list of
participants). One of the issues they
have identified to work together on is
related to the GHS, and making the
business case for GHS adoption,
particularly for small businesses. OSHA
has conducted a roundtable of Alliances
interested in this topic, and will
continue these meetings to get their
input and work with them on products
they identify as appropriate for
development. Products under
consideration include a document
addressing frequently asked questions
and the corresponding answers, as well
as a document that addresses why the
GHS is needed.
D. Benefits of the GHS
Development of this system required
extensive work by a great number of
people, and resources from many
countries and organizations. The reason
it received such support is that there is
a widespread belief that there are
significant benefits associated with
implementation of a globally
harmonized approach to hazard
communication. Countries,
international organizations, chemical
producers and users of chemicals will
all benefit.
First and foremost, implementation of
the GHS will enhance protection of
people potentially exposed to chemicals
and the environment. While some
countries such as ours already have the
benefits of protection under existing
systems, the majority of countries do not
have such comprehensive approaches.
Thus implementation of the GHS will
provide these countries with the
important protections that result from
dissemination of information about
chemical hazards and protective
measures. In our country, we expect that
adoption of the GHS would improve
and build on protections we already
have. Refinement of the information
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provided would help improve
comprehensibility and thus make it
more likely that the information will
result in workplace changes to protect
employees. As has already been noted,
the majority of affected employers and
employees should benefit from adoption
of the GHS through receipt of better,
more standardized, and consistent
information about chemicals in their
workplaces.
Secondly, implementation of such an
approach would facilitate international
trade in chemicals. It will reduce the
burdens caused by having to comply
with differing requirements for the same
product, and allow companies that have
not had the resources to deal with those
burdens to be involved in international
trade. This is particularly important for
small producers who may be precluded
currently from international trade
because of the compliance resources
required to address the extensive
regulatory requirements for
classification and labeling of chemicals.
Third, one of the initial reasons this
system was pursued internationally
involved concerns about animal welfare
and the proliferation of requirements for
animal testing and evaluation. Where
existing systems have different
definitions of hazards, it often results in
duplicative testing to produce data
related to the varying levels of toxicity
or cut-offs used to define the hazards in
the different systems. Having one agreed
definition will reduce this duplicative
testing. It should be noted that OSHA
has no testing requirements. The HCS is
based on collecting and evaluating the
best available evidence on the hazards
of each chemical.
Information transmittal systems
provide the underlying infrastructure
for the sound management of chemicals
in a country. Those countries that do
not have the resources to develop and
maintain such a system can use the GHS
to build their chemical safety and health
programs. Unlike some other safety and
health issues, a country’s approach to
the sound management of chemicals
definitely affects other countries. In
some cases, bordering countries may
experience pollution and other effects of
uncontrolled chemical exposures. In all
countries, there is a need to acquire
sufficient information to properly
handle the chemical when it is imported
from other countries. Thus having a
coordinated and harmonized approach
to the development and dissemination
of information about chemicals will be
mutually beneficial to both importing
and exporting countries.
In the U.S., the four primary
regulatory agencies (OSHA, EPA, CPSC,
and DOT) that would be responsible for
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GHS implementation are not
domestically harmonized in terms of
definitions of hazards and other
requirements related to classification
and labeling of chemicals. Thus, if all
four agencies adopt the GHS, the U.S.
would have the additional benefit of
harmonizing the overall U.S. approach
to classification and labeling. Since
most chemicals are produced in a
workplace and shipped elsewhere,
every manufacturer deals with at least
two of the U.S. systems. Thus every
producer is likely to experience some
benefits from domestic harmonization,
in addition to the benefits that will
accrue to producers involved in
international trade.
OSHA believes that adoption of the
GHS could also address some of the
issues that have been discussed in the
U.S. regarding the HCS and its
implementation, such as improving
labels and SDS comprehensibility
through implementation of a
standardized approach. The current
regulatory system includes a
performance-oriented approach to labels
and SDSs, allowing the producers to use
whatever language or format they
choose to provide the necessary
information. This often results in a lack
of consistency that makes it difficult for
some users of chemicals to properly
identify the hazards and the protective
measures, particularly when purchasing
the same product from multiple
suppliers. Having the information
provided in the same words and
pictograms on labels, as well as having
a standardized order of information on
SDSs, would help all users identify the
critical information necessary to protect
employees.
E. State Plan States
If Federal OSHA promulgates a final
rule amending its HCS in response to
the GHS, the 26 States and U.S.
Territories with their own OSHAapproved occupational safety and health
plans would be required to revise their
standards to reflect the new amendment
within six months of Federal
promulgation. 29 CFR 1953.5(a). A
revised State hazard communication
standard must be applicable to both the
private and public (State and local
government employees) sectors. Some
States may have statutory provisions
that would require amendment in order
to conform to a revised Federal HCS.
Section 18(c)(2) of the OSH Act
requires that State standards applicable
to products distributed or used in
interstate commerce, if not identical to
the Federal standard, must be required
by compelling local conditions and
must not unduly burden interstate
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commerce, in addition to being ‘‘at least
as effective’’ as the Federal standard.
The amended HCS, like the original
standard, would be ‘applicable to
products’ in the sense that it would
permit the distribution and use of
hazardous chemicals in commerce only
if they are in labeled containers
accompanied by safety data sheets[.]’’ 48
FR 53280, 53323, November 25, 1983. In
order to assure that State standards do
not pose an undue burden on interstate
commerce, and to advance the goals of
the GHS, OSHA would expect to closely
scrutinize resultant State standards to
assure not only equal or greater
effectiveness, but also that any different
or additional requirements do not
conflict with, or adversely affect, the
effectiveness of the national application
of OSHA’s standard.
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II. Provisions of OSHA’s HCS and the
GHS
A. Scope of the GHS
The GHS covers chemicals in various
stages of their life cycle, from
production to disposal. It is based
primarily on the hazards of chemicals.
The GHS is designed to allow regulatory
authorities to choose provisions that are
appropriate to their particular scope of
regulation. This is referred to as the
‘‘building block approach.’’ The GHS
includes all of the building blocks or
possible regulatory components that
might be needed for classification and
labeling requirements in the workplace
as well as for regulation of classification
and labeling of pesticides, chemicals in
transport, and consumer products.
Therefore, regulatory authorities such as
OSHA would choose the provisions of
the GHS that are necessary for the
protection of employees, but would not
adopt others that address other types of
protection. For example, the GHS
includes harmonized criteria for
classifying chemicals for aquatic
toxicity. Since OSHA does not have the
regulatory authority to address
environmental concerns, OSHA would
not adopt the GHS criteria for aquatic
toxicity. It is expected that other U.S.
agencies that regulate environmental
issues will consider adopting this
definition. Similarly, the GHS safety
data sheet format includes a section that
addresses environmental information.
OSHA would not require inclusion of
environmental information for SDSs
used in workplaces.
The building block approach may also
be applied in other ways when deciding
which parts of the system to adopt. For
example, the GHS includes
classification criteria, labels, and SDSs.
While workplace authorities such as
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OSHA are likely to adopt all of these
elements, it is expected that consumer
product authorities will not have SDS
requirements, nor will transport
authorities. The building block
approach may also be applied to the
criteria for defining hazards. For
example, the acute toxicity criteria are
much broader than those we currently
have in the HCS for workplace
exposures. This is to allow consumer
product authorities the tools they need
to address the protection of children
who might accidentally be exposed.
OSHA would not need to adopt all of
the categories of acute toxicity in order
to protect employees from the types of
exposures they may have.
In addition to the building block
approach, the GHS also contains a
number of areas that are left to the
competent authority to determine how
to apply the provision. Where OSHA is
the competent authority, i.e., in terms of
workplace protections in the U.S., the
Agency expects to maintain its current
approaches in terms of interpretations
and accommodations regarding
application. These approaches are based
on the rulemaking record, as well as
implementation experiences in the U.S.,
and have been determined to be an
appropriate application. For example,
the scope and application provisions in
the GHS address the interface of the
OSHA requirements to requirements in
other agencies that address the same
products. These scope interpretations
are expected to be the same if OSHA
adopts the GHS.
Overall, the scope of the GHS with
regard to chemicals covered, as well as
types of chemicals and workplaces that
are covered, is very similar to the HCS.
The HCS has a very broad scope of
coverage, ensuring that information is
provided on all potential hazards in
American workplaces. Adoption of the
GHS should maintain this broad
coverage of hazards and chemicals. It
should be noted that the GHS, like the
HCS, does not require any new testing
of chemicals. Evaluations of chemical
hazards are to be based on the best
available evidence.
As has been described above, the HCS
consists of requirements for defining
health and physical hazards, preparing
a written hazard communication
program, preparing and distributing
labels on containers that are shipped as
well as containers in the workplace,
preparing and distributing safety data
sheets for all hazardous chemicals, and
employee training. The GHS addresses
classification of health and physical
hazards, and preparation and
distribution of labels and safety data
sheets. It does not include requirements
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for a written hazard communication
program or for employee training.
Training is noted in the GHS as an
important adjunct to label and safety
data sheet requirements, but the
harmonization process did not include
such provisions. Countries are thus free
to determine what training will be
applicable in their own regulatory
approach. OSHA believes that training
is critical to ensuring the effectiveness
of hazard communication, and
anticipates maintaining current HCS
requirements that training be part of a
hazard communication program. OSHA
also expects to propose some additional
training to ensure understanding of the
new approach regarding labels and
SDSs in the GHS.
B. Definitions of Hazards Covered
The HCS covers a broad range of both
health and physical hazards. The
standard is performance-oriented,
providing definitions of hazards and
parameters for evaluating the best
available evidence to determine whether
a chemical has a hazardous effect under
the standard. In particular, with regard
to health hazards, one toxicological
study, conducted according to
established scientific principles and
reporting a statistically significant
adverse health effect, is sufficient for a
finding of hazard under the rule. The
principle behind the standard is that it
is to address dissemination of
information, and thus complete
information about all of the potential
hazards should be disseminated to
ensure that employers and employees
can make appropriate decisions about
the level of protection required in their
particular workplaces. Hazard
information, in combination with
information about the exposures
occurring in each workplace, allows
decisions to be made by employers
regarding the appropriate risk
management to implement based on the
specific conditions in their workplace.
Chemical manufacturers and importers
do not have information about the
exposures to their products in each
workplace where their product may be
used, so they must prepare their labels
and safety data sheets based on the
hazards of the chemicals.
C. Health Hazards
The HCS thus covers every type of
health effect that may occur, including
both acute and chronic effects. The
standard describes different systems of
the body and indicates that target organ
effects are to be considered in the
hazard evaluation. The definitions
provided are indicative of the wide
range of coverage, but are not exclusive.
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Any type of adverse health effect that is
reported and substantiated by a
scientific study is covered. The standard
specifically includes the following in
the definition of ‘‘health hazard’’:
Carcinogens
Toxic or highly toxic agents (all routes of
entry)
Reproductive toxins
Irritants
Corrosives
Sensitizers
Hepatotoxins
Nephrotoxins
Neurotoxins
Agents which act on the hematopoietic
system
Agents which damage the lungs, skin, eyes,
or mucous membranes
The GHS also has a very broad
approach to the range of health effects
covered:
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Acute toxicity (any route of entry)
Skin corrosion/irritation
Serious eye damage/eye irritation
Respiratory or skin sensitizer
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
Specific target organ systemic toxicity—
single exposure
Specific target organ systemic toxicity—
repeated use
Aspiration hazard
Under the GHS, each hazard or
endpoint as listed above is considered
to be a hazard class. The classes are
generally sub-divided into categories of
hazard. The definitions of hazards are
much more specific and detailed than
what is in the HCS. For example, under
the HCS, a chemical is either a potential
carcinogen or it is not. The evaluation
is a yes or no response. Under the GHS,
there are two categories of
carcinogenicity, based on the weight of
the evidence involved. The hazard
communication consequences of this
classification also vary as a result for
each category in a hazard class. The
hazard communication elements
allocated to each category reflect the
degree of severity of the hazard.
There are advantages to this more
specific and delineated approach. First,
the detailed criteria for classification
should lead to more accurate hazard
determinations and more consistency
among multiple classifiers. There is less
likely to be room for different
interpretations of the same data. This
addresses some of the concerns that
have been raised about the HCS. In
addition, introducing categories gives an
indication of the degree of severity of
the hazard. This is helpful to employers
and employees determining what the
appropriate course of action should be
when exposures to the chemical occur.
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There may be some changes in what
the hazard of certain chemicals is
determined to be based on a
consideration of the data available on a
chemical in light of these new criteria.
It is expected that chemical
manufacturers and importers will be
required to re-evaluate their chemicals
according to the GHS criteria. But given
the current broad nature of the HCS, it
is not expected that the number of
chemicals covered would change in any
significant way. The most likely
difference would be that the chemical
may be characterized in categories for
certain hazards based on the weight of
the evidence.
With regard to mixtures of chemicals,
the HCS requires the evaluation of
mixtures to be based either on data for
the mixture as a whole, or, where that
is not available, the mixture’s health
hazards are to be based on the presence
of ingredients with health hazards over
a specified percentage. That percentage
is 0.1% for carcinogens, and 1.0% for all
other types of health effects. The HCS
also recognizes that risk may remain
below these cut-offs, and where there is
evidence that is the case, the mixtures
are still covered.
The GHS has what has been described
as a tiered approach to mixture
evaluation. The first step is
consideration of data on the mixture as
a whole, similar to the HCS. The second
step allows the use of ‘‘bridging
principles’’ to estimate the hazards of
the mixture based on information about
its components. For example, if a
chemical is considered to be acutely
toxic, but it is diluted with something
that is not toxic, the GHS allows the
employer to take the dilution into
consideration when evaluating the
hazards of the product rather than
simply basing it on a percentage cut-off
approach like the HCS. This
extrapolation of data will mean that
fewer mixtures will be evaluated on the
basis of the presence of a chemical
above a specific cut-off. The third part
of the tiered approach does involve cutoffs, but they vary by the type of effect.
In particular, for acute effects, there is
a formula for determining whether the
mixture is considered to be toxic. The
formula is based to some extent on one
that is currently used in transport.
Overall, the approach is generally
consistent with the current HCS
requirements, but provides more detail
and specification and allows more
extrapolation of data available on the
components of a mixture—particularly
for acute effects. It is thus more
complicated than the approach in the
HCS, and it is likely that additional
guidance, particularly electronic tools,
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may need to be made available to assist
with compliance.
As a result of these differences in
health hazard criteria and the
accompanying approaches to classifying
mixtures, another provision of the
standard that is potentially impacted by
adoption of the GHS is the process of
hazard determination. Under the current
rule, this process is performanceoriented, allowing for a significant
degree of professional judgment on the
part of the hazard evaluator. No specific
procedures are provided, but there are
certain parameters established. The
scientific literature must be reviewed,
and if there is at least one toxicological
study, conducted according to
established scientific principles, and
providing statistically significant results
indicating an adverse health effect, this
hazard must be disclosed under the
HCS.
The HCS also includes references to
sources of information that were
identified in the rulemaking record as
one basis for making an initial
determination of hazard. Among these
listed sources are OSHA’s substancespecific standards (those chemicals for
which OSHA has promulgated a
permissible exposure limit (PEL) in
Subpart Z, Toxic and Hazardous
Substances), American Conference of
Governmental Industrial Hygienists
(ACGIH) Threshold Limit Values
(TLVs), International Agency for
Research on Cancer (IARC) monographs,
and the National Toxicology Program
(NTP) list of carcinogens. These sources
provide employers a list of hazardous
chemicals. However, manufacturers and
importers are still required to review the
available information to determine
specifically what the hazards of these
chemicals are, and to disclose them on
labels and safety data sheets.
The GHS provides much more
specific criteria for defining health
hazards than the HCS does. If OSHA
adopts the GHS, these more specific
criteria will be part of the HCS. This
will eliminate the need for a specific
listing of hazardous chemicals as part of
the hazard determination procedures.
Chemical manufacturers and importers
are much more likely to make consistent
hazard determination evaluations
following the specific criteria in the
GHS, thus addressing the concerns that
led to the inclusion of lists in the
original Hazard Communication
Standard. References to the chemicals
for which there are ACGIH TLVs, and
those chemicals addressed in IARC
Monographs and the NTP lists, would
no longer be specifically addressed in
the HCS. Chemical manufacturers and
importers would retain the
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responsibility for evaluating all relevant
data on the chemicals they produce or
import.
Similarly, the provisions for
disclosing the hazardous ingredients of
mixtures under the GHS are much more
detailed than the HCS. The simple
across-the-board cut-offs for all types of
hazards would no longer be part of the
rule if it is changed to adopt the GHS.
Modifying the HCS to align with the
GHS would also eliminate the current
references to ACGIH TLVs as part of the
mixture provisions.
D. Physical Hazards
With regard to physical hazards, the
current definitions in the HCS are
drawn from other standards we have
that address such chemicals (e.g.,
flammable chemicals), or from what
were the DOT criteria for physical
hazards at the time OSHA promulgated
the HCS. OSHA includes definitions for
the following physical hazards in the
HCS:
Combustible liquid
Compressed gas
Explosive
Flammable (aerosol, gas, liquid, solid)
Organic peroxide
Oxidizer
Pyrophoric
Unstable (reactive)
Water-reactive
The GHS includes criteria for the
following physical hazards:
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Explosives
Flammable (aerosol, gas, liquid (including
combustible liquid), solid)
Oxidizing (liquids, solids, gases)
Gases under pressure
Self-reactive substances and mixtures
Pyrophoric (liquid, solid)
Self-heating substances and mixtures
Substances and mixtures which in contact
with water emit flammable gases
Organic peroxide
Corrosive to metals
DOT subsequently changed their criteria
to be consistent with the international
transport requirements. The
international transport requirements for
classification of physical hazards have
now been incorporated into the GHS.
While DOT must make a few changes to
be consistent with the GHS, their
requirements are mostly already the
same.
OSHA is not harmonized with current
DOT requirements. Changing the HCS to
adopt the GHS criteria would also
ensure that DOT and OSHA
requirements are consistent. This is an
important improvement in the current
situation where the outside of a truck
may be placarded with a different
hazard than the workplace labels
convey on the containers inside the
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truck. Again, chemical manufacturers
and importers would have to re-evaluate
their chemicals according to the new
criteria in order to ensure they are
classified appropriately. However, if
they are chemicals that are transported,
i.e., not produced and used in the same
workplace, this classification should
largely be done already for purposes of
complying with DOT’s existing
transport provisions. This should
minimize the additional work required
to review the physical hazard
classifications to be consistent with the
GHS for purposes of workplace
classification and labeling.
One issue of concern is whether
OSHA should also propose to change
the physical hazard definitions in other
standards when it proposes to change
the HCS criteria to be consistent with
the GHS. For example, if the HCS
definitions are changed with regard to
the definition of flammable liquids,
there is a concern as to whether
definitions in the flammable liquids
standard need to be changed as well,
and what the impact of this would be
beyond classification and labeling. This
is one of the areas that needs to be
further explored in terms of impact and
possible consequences.
E. Labels
The HCS requirements for labels
simply indicate the minimal
information required to be on them. At
the time the standard was promulgated,
OSHA reviewed the current industry
consensus standards for labels, and
basically focused on requiring
information that was not generally
present on most labels in use by
industry. The additional information
included an identity that could be
traced to more detailed information, and
specific information about both the
health and physical hazards. In
particular, OSHA did not consider a
label statement indicating possible harm
but no specific health effect to be a
sufficient hazard communication. Other
types of information such as
precautionary statements were not
included in the requirements.
This performance-oriented approach
was strongly supported by the chemical
industry at the time the standard was
adopted. Taking such an approach
allowed existing labels to continue to be
used in many situations, thus
minimizing the impact on a number of
producers.
However, it also has resulted in labels
that are not consistent, and may not
communicate adequately to users. While
some producers follow voluntary
industry consensus standards, others do
not. Many large companies have
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developed their own libraries of phrases
to be used on labels and safety data
sheets, and undertaken translation of
them into multiple languages. This is a
considerable burden for a company to
develop and maintain.
Other major existing systems
considered in the harmonization
process included specific label phrases
to convey hazards and other
information. Symbols and pictograms
were also part of these systems. For
purposes of developing an agreed
harmonized approach, it was thus
necessary to consider including such
elements in the GHS.
For each class and category of hazard
under the GHS that OSHA is
considering adopting, there is a
harmonized hazard statement, a signal
word, and a pictogram specified. This is
referred to as the core information for a
chemical. Thus once an employer
classifies a chemical, the GHS provides
the specific core information to convey
to users on that chemical. There are
provisions to allow supplementary
information as well so the chemical
manufacturer is not limited to the
specified core information. This should
address product liability concerns for
U.S. employers and ensure they can
include other information they consider
to be necessary for that purpose.
Precautionary statements are also
provided as examples in the GHS, but
they have not yet been agreed and
harmonized. This is expected to occur
in the future as work on the system
continues. Figure 1 is an example of
how the core labeling elements
(harmonized hazard statement, signal
word, and pictogram) are assigned in
one hazard class covered under the
GHS.
These labeling provisions will likely
be the biggest difference between the
HCS and the GHS. There are benefits to
this standardized approach. First,
employers and employees will be given
the same information on a chemical
regardless of the supplier. This
consistency will 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. Literacy of both types is a
significant concern in American
workplaces. Secondly, having the core
information developed already,
translated into multiple languages, and
readily available to whomever wishes to
access it, will eliminate the burden of
chemical manufacturers and importers
developing and maintaining their own
such systems. Thus the specification
approach should be beneficial both to
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United Nations Globally Harmonized
System of Classification and Labeling of
Chemicals, First Revised Edition, 2005,
Annex I. Diamond frames for pictograms
in the top row are red.
The use of symbols and pictograms
will require some training and
familiarization to be effective. One of
the issues OSHA is considering is
whether generic training on this aspect
of the GHS can be developed and made
available to employers and employees.
There is another significant benefit
that will be achieved by adopting a
system that has harmonized hazard
statements in it. ‘‘Control banding,’’ a
guidance approach to recommending
control measures for chemical
exposures, is attracting significant
attention around the world. The
approach uses information that is
readily available to small and mediumsized employers with chemicals in their
workplaces to provide them with
workplace-specific control
recommendations. Basically, the system
uses such information to estimate the
degree of severity of the hazard and the
amount of chemical present, and relates
that to the degree of control needed. The
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control banding approach relies on
harmonized hazard statements to allow
the system to estimate the degree of
severity of the hazard. Initially based on
the European hazard classification
system, it has now been converted to the
GHS phrases. The use of control
banding to provide guidance for
chemical safety and health approaches
in U.S. workplaces cannot be
accomplished until harmonized hazard
statements are readily available.
Adoption of the GHS and its phrases
would open up the possibility that
control banding guidance can be used in
the U.S. to help small and mediumsized employers select and implement
appropriate control measures. In
addition, the possibility of addressing
control banding recommendations in
GHS SDSs in the section on controls is
also being explored. For more
information on control banding, please
see https://www.cdc.gov/niosh/topics/
ctrlbanding/.
F. Safety Data Sheets
Under the HCS, the SDS is the
detailed reference source on the
chemical. While labels provide a quick
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snapshot to remind employers and
employees of the hazards of the
chemical, the SDS addresses all aspects
of hazard information as well as
methods for handling and use. The HCS
specifies what information must be
included on the SDS, but does not
specify a format or order of information.
Again, this approach was supported by
producers to minimize the impact of the
standard for those who already
developed and disseminated SDSs.
Currently, safety data sheets under the
HCS are required to include:
Identification of the chemical or hazardous
ingredients of a mixture
Physical and chemical characteristics
Health hazards, including signs, symptoms,
and medical conditions that could be
aggravated by exposure
The primary routes of entry
The OSHA permissible exposure limit,
ACGIH Threshold Limit Value, and any
other recommended exposure limits
Whether the chemical is considered to be a
carcinogen by OSHA, the International
Agency for Research on Cancer, or the
National Toxicology Program
Precautions for safe handling and use
Control measures
Emergency and first aid procedures
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the producers and the users of
chemicals.
Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Proposed Rules
Date of preparation of the safety data sheet
Contact information for the responsible party
Users of chemicals have always
preferred a standardized approach.
Many believe that having the
information in the same place on every
data sheet allows them to access it more
effectively. OSHA published a request
for information regarding ways to
improve the information provided
under the HCS (55 FR 20580; May 17,
1990), and received around 600
comments in response. The majority of
them were in favor of a standardized
format or order of information.
As a result of the users’ expressed
preferences, chemical manufacturers in
the U.S. developed a voluntary industry
consensus standard that included an
order of information for safety data
sheets (ANSI Z400.1). This approach
was later adopted into international
voluntary industry consensus standards
as well.
The HCS allows any format to be
used, so many producers have been
following the consensus standard order
of information for some years. In
negotiating the GHS, it was decided that
this format should be adopted there as
well. One change was made, reversing
the order of sections 2 and 3 so the
hazard information appeared earlier in
the sheet than information on chemical
composition. Both the national and
international industry consensus
standards are being changed to be
consistent with this approach. The GHS
data sheet is to include the following in
this order:
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Identification
Hazard identification
Composition/information on ingredients
First aid measures
Firefighting measures
Accidental release measures
Handling and storage
Exposure controls/personal protection
Physical and chemical properties
Stability and reactivity
Toxicological information
Ecological information
Disposal considerations
Transport information
Regulatory information
Other information
Having a standardized order of
information should improve
comprehensibility, which has been a
continuing issue with regard to safety
data sheets. It should also make it easier
for chemical producers to comply by
providing them with a template to
follow. Using the industry consensus
standards should also minimize the
burden of preparing new safety data
sheets since many chemical producers
already use the format specified. While
the GHS safety data sheet does not
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address exposure limits in the titles of
the sections, guidance on what should
be included indicates that occupational
exposure limits would be addressed
under the ‘‘exposure controls’’ section.
Countries may choose what to require in
these sections in terms of occupational
exposure limits, but it is anticipated that
OSHA would require the PELs to be
included.
Under the auspices of the
International Program on Chemical
Safety (IPCS), a series of over 1300
international chemical safety cards has
been developed and translated into 14
languages. These cards are developed
and peer reviewed by participating
institutions in a number of countries,
including the U.S. The National
Institute for Occupational Safety and
Health (NIOSH) is undertaking this
work. The cards are similar to SDSs in
terms of the information provided, but
they are in a concise format of two
pages. The cards are going to be updated
to reflect the GHS criteria and hazard
information. They may be found on
NIOSH’s Web page at: https://
www.cdc.gov/niosh/ipcs/nicstart.html
OSHA also has a link to them on our
hazard communication page. These
cards are an excellent resource for many
of the most common chemicals found in
the workplace. When updated to be
GHS-consistent, they will also be a
useful resource for GHS compliance and
for implementation of control banding.
As mentioned earlier, there is
information required on a GHS SDS that
is outside OSHA’s jurisdiction to
regulate. This includes environmental
and transport information. We do not
intend to propose requiring it on safety
data sheets, but will provide
information about the provisions so
chemical producers can include it if
they wish to be completely consistent
with the GHS. OSHA does not preclude
such information being on a safety data
sheet, but will not review or enforce
such provisions.
III. Public Resources for Further
Information on the GHS
OSHA has a safety and health topic
page on hazard communication
available as part of our Web site. There
is a hazard communication button on
the Agency’s home page (https://
www.osha.gov) that leads to a portal
page on the topic, including a box on
the GHS. There is a page devoted to the
GHS that is reached through clicking on
this box. It gives additional background
information, and has links to the GHS
official text, Web pages of other U.S.
agencies, international organizations,
and countries involved in GHS
implementation.
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As noted earlier, a substantive guide
to the GHS is available on this page to
describe the system in more detail for
those who are interested. There is also
a detailed comparison of the HCS to the
GHS that notes the areas of difference
that would have to be addressed in
adopting the GHS.
IV. Request for Input
In order to prepare for rulemaking
proposing adoption of the GHS and
modification of the HCS to accomplish
that, OSHA is seeking input from the
public on a number of issues related to
implementation. This information will
be used by OSHA to prepare cost
analyses and other documents required
to support the rulemaking. These
requests are divided into several
categories of information below. Please
provide comments, evidence, data, and
other input for those categories that
affect you or for which you have
relevant information. The details for
submitting this information are
specified in Section V.
Current situation. Modifying the HCS
to adopt the GHS would have the
greatest impact on chemical
manufacturers, importers, and
employers who produce or distribute
hazardous chemicals as currently
covered under the HCS. In order to be
harmonized, the hazard classifications
of each product will need to be
reviewed according to the classification
criteria of the GHS, and new labels and
safety data sheets will have to be
prepared.
1. How many hazardous chemicals as
defined by the HCS do you produce,
import or distribute? How many
hazardous chemicals do you export?
How many different labels or data
sheets do you need to prepare for each
chemical you export?
2. Who is responsible for reviewing
the data on chemicals and preparing
appropriate labels and safety data
sheets? What is their professional
background? Do you make independent
determinations or rely largely on labels
or data sheets developed by others
(suppliers, materials available on the
Internet, etc.)?
3. How long does it take on average
for each hazardous chemical to
complete the review and prepare new
labels and safety data sheets? How
much does it cost for each chemical
product? Please break down the cost for
the classification, preparation of a new
label, and revision of a safety data sheet.
4. Would the time required to prepare
a GHS SDS be more, less, or about the
same as currently required for preparing
an SDS? What time and costs would be
required to convert existing SDSs to the
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GHS format? Would the costs depend on
the amount of time allowed for the
conversion process?
5. Please describe any electronic tools
you have to assist with this process,
such as systems that classify chemicals
or prepare labels or safety data sheets.
How long would it take to update those
systems to make them GHS-consistent?
6. How many of your employees
receive hazard communication training?
How many hours of training at what
frequency (on hire, annually, as needed,
etc.)? How long would it take to teach
employees to recognize GHS
pictograms? Would more standardized
labels and SDSs make it easier to use the
available hazard communication
information?
7. What savings will you incur when
you only have to classify a chemical
once instead of multiple times
depending on how many agencies and
countries are involved? What other
benefits do you anticipate?
Timing. As has been noted, the
international goal is for as many
countries as possible to adopt the GHS
by 2008. Since OSHA has longstanding
requirements for labels and safety data
sheets, the Agency expects to allow a
significant phase-in period for
compliance in order to give people
sufficient time to review their
classifications and amend them as
necessary, and subsequently revise
labels and safety data sheets to reflect
the new requirements. It seems probable
at this point that the revised
requirements could potentially be in
place by 2008, but the phase-in period
for compliance may have to extend
beyond that time period.
8. What is a reasonable time period
for phasing in the modifications?
Should the phasing be done by size of
business? Are there any other factors
that should be considered to
differentiate the phasing?
9. What is the normal cycle for
updating labels and safety data sheets?
10. Do you have stockpiles of product
that are already labeled? How long will
those stockpiles last?
11. Do you have any other
information or data that would help
OSHA determine the appropriate
phasing in of the new requirements or
other issues related to timing?
Technical issues. As discussed, the
scope of hazards covered by the GHS is
similar to that of the HCS. OSHA
anticipates adopting all of the health
and physical hazard criteria in the GHS.
Definitions in the HCS will need to be
the same as the GHS in order to be
harmonized. However, there are some
determinations that are left to countries
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to decide in terms of whether all
categories and all hazards are adopted.
12. Are there any health or physical
hazards that are currently covered by
the HCS that you think are not
adequately addressed in the GHS
criteria? What are they and why do you
think they are not adequately
addressed? Are there any health or
physical hazards that aren’t covered in
either the HCS or the GHS that should
be added?
13. In addition to references to
hazardous chemicals with OSHA PELs,
should OSHA propose to include any
other listing of hazardous chemicals
when aligning the hazard determination
provisions of the HCS to the GHS?
Should OSHA propose that the mixture
provisions only reference exceeding the
OSHA PEL when revised to adopt the
GHS? Should OSHA propose deleting
the requirement that the ACGIH TLV be
included on the SDS when the
requirements are changed to be
consistent with the GHS? Should other
recommended exposure limits be
included on the SDS?
14. Within the health hazard criteria,
are there any categories of hazard that
should not be adopted in the HCS? For
example, should OSHA adopt all of the
categories addressed in the acute
toxicity criteria? If not, what categories
would be appropriate to address
anticipated workplace exposures?
15. If OSHA changes the HCS to adopt
the physical hazard criteria, how will
that impact other OSHA standards that
use the same criteria as the HCS? Does
OSHA need to change those criteria at
the same time the HCS is changed?
Storage and handling requirements for
flammable liquids are one example that
has been identified as a potential
problem if different definitions apply,
and information on a safety data sheet
is linked to the definition in the HCS
but not consistent with other
definitions.
16. Are there any other technical
issues that need to be considered in
adopting the GHS? Please explain.
Compliance Assistance and Outreach.
OSHA is interested in getting input on
the types of materials or products that
would assist employers in
understanding whatever modifications
OSHA makes to the HCS to adopt the
GHS, and to help them achieve
compliance. To this end, we would like
to get input now on the types of
outreach that would be most helpful. As
has been noted, there are some
explanatory documents that are already
available on OSHA’s Web site.
17. What products would be most
useful to employers? Employees? Do
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Sfmt 4702
you prefer paper publications?
Electronic tools?
18. What subjects would be of most
interest? Classification criteria and
procedures for substances and mixtures?
Labels? Safety data sheets?
19. What is the best way to distribute
the materials to reach affected
employers and employees?
20. Are there any types of materials
that would be especially appropriate for
small businesses? Most small businesses
would be users of chemicals, rather than
producers, so they will be receiving
labels and safety data sheets prepared
according to the new approach. Are
there training materials that would be
helpful to learn or teach about the new
approach? In particular, would training
on symbols or pictograms be of use?
V. Public Participation
You may submit comments in
response to this document by (1) hard
copy, (2) fax transmission (facsimile), or
(3) electronically through the OSHA
Web page or the Federal Rulemaking
Portal. Because of security-related
problems, there may be a significant
delay in the receipt of comments by
regular mail. Please contact the OSHA
Docket Office at (202) 693–2350 for
information about security procedures
concerning the delivery of materials by
express delivery, hand delivery, and
courier service.
All comments and submissions are
available for inspection and copying at
the OSHA Docket Office at the above
address. Comments and submissions
posted on OSHA’s Web page are
available at https://www.osha.gov (click
on ‘‘Dockets & E-Comments’’). OSHA
cautions you about submitting personal
information such as Social Security
numbers and birth dates. Contact the
OSHA Docket Office for information
about materials not available through
the OSHA Web page and for assistance
in using the Web page to locate docket
submissions.
Electronic copies of this Federal
Register notice, as well as news releases
and other relevant documents, are
available on OSHA’s Web page.
VI. Authority and Signature
This document was prepared under
the direction of Edwin G. Foulke, Jr.,
Assistant Secretary for Occupational
Safety and Health, U.S. Department of
Labor. It is issued pursuant to sections
4, 6, and 8 of the Occupational Safety
and Health Act of 1970 (29 U.S.C. 653,
655, 657), 29 CFR part 1911, and
Secretary’s Order 5–2002 (67 FR 65008).
E:\FR\FM\12SEP1.SGM
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Federal Register / Vol. 71, No. 176 / Tuesday, September 12, 2006 / Proposed Rules
Issued at Washington, DC, this 6th day of
September 2006.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational
Safety and Health.
[FR Doc. 06–7584 Filed 9–7–06; 9:37 am]
BILLING CODE 4510–26–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
this rulemaking CGD05–06–092,
indicate the specific section of this
document to which each comment
applies, and give the reason for each
comment. Please submit all comments
and related material in an unbound
format, no larger than 81⁄2 by 11 inches,
suitable for copying. If you would like
to know they reached us, please enclose
a stamped, self-addressed postcard or
envelope. We will consider all
comments and material received during
the comment period. We may charge
this proposed rule in view of them.
33 CFR Part 165
Public Meeting
[CGD05–06–092]
We do not now plan to hold a public
meeting. But you may submit a request
for a meeting by writing to Commander,
Sector North Carolina at the address
under ADDRESSES explaining why one
would be beneficial. If we determine
that one would aid this rulemaking, we
will hold one at a time and place
announced by a later notice in the
Federal Register.
RIN 1625–AA00
Safety Zone: Fireworks Display, Trent
River, New Bern, NC
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
SUMMARY: The Coast Guard proposes the
establishment of a 1000 foot safety zone
around a fireworks display for the North
Carolina Parks and Recreation
Conference occurring on November 12,
2006, on the Trent River, New Bern, NC.
This action is intended to restrict vessel
traffic on the Trent River. This safety
zone is necessary to protect mariners
from the hazards associated with
fireworks displays.
DATES: Comments and related material
must reach the Coast Guard on or before
October 12, 2006.
ADDRESSES: You may mail comments
and related material to Commander,
Coast Guard Sector North Carolina, 2301
East Fort Macon Road, Atlantic Beach,
NC 28512. Sector North Carolina
maintains the public docket for this
rulemaking. Comments and material
received from the public. As well as
documents indicated in this preamble as
being available in the docket, will
become part of this docket and will be
available for inspection or copying at
the Federal Building Fifth Coast Guard
District between 9 a.m. and 2 p.m.,
Monday through Friday, except Federal
Holidays.
FOR FURTHER INFORMATION CONTACT:
CWO Christopher Humphrey,
Prevention Department, Coast Guard
Sector North Carolina, at (252) 247–
4525.
sroberts on PROD1PC70 with PROPOSALS
SUPPLEMENTARY INFORMATION:
Request for Comments
We encourage you to participate in
this rulemaking by submitting
comments and related material. If you
do so, please include your name and
address, identify the docket number for
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Background and Purpose
On November 12, 2006, the North
Carolina Parks and Recreation
Conference fireworks display will be
held adjacent to the Trent River, New
Bern, NC. Spectators will be observing
from both the shore and from vessels.
Due to the need of protection of
mariners and spectators from the
hazards associated with the fireworks
display, vessel traffic will be
temporarily restricted.
Discussion of Proposed Rule
The Coast Guard is establishing a
safety zone on specified waters of the
Trent River. The regulated area will
consist of a 1000 foot safety zone around
a fireworks display from the southern
shore of the City of New Bern, NC. The
safety zone will be enforced from 6 p.m.
to 8 p.m. on November 12, 2006.
General navigation in the safety zone
will be restricted during the event.
Except for participants and vessels
authorized by the Coast Guard Patrol
Commander, no person or vessel may
enter or remain in the regulated area.
Regulatory Evaluation
This proposed rule is not a
‘‘significant regulatory action’’ under
section 3(f) of Executive Order 12866,
Regulatory Planning and Review, and
does not require an assessment of
potential costs and benefits under
section 6(a)(3) of that Order. The Office
of Management and Budget has not
reviewed it under that Order. It is not
‘‘significant’’ under the regulatory
policies and procedures of the
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53627
Department of Homeland Security
(DHS).
We expect the economic impact of
this proposed rule to be so minimal that
a full Regulatory Evaluation under the
regulatory policies and procedures of
DHS is unnecessary. Although this
regulation restricts access to the
regulated area, the effect of this rule will
not be significant because: (i) The COTP
may authorize access to the safety zone;
(ii) the safety zone will be in effect for
a limited duration; and (iii) the Coast
Guard will make notifications via
maritime advisories so mariners can
adjust their plans accordingly.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), we have considered
whether this proposed rule would have
a significant economic impact on a
substantial number of small entities.
The term ‘‘small entities’’ comprises
small businesses, not-for-profit
organizations that are independently
owned and operated and are not
dominant in their fields, and
governmental jurisdictions with
populations of less than 50,000.
The Coast Guard certifies under 5
U.S.C. 605(b) that this proposed rule
would not have a significant economic
impact on a substantial number of small
entities.
This rule will affect the following
entities, some of which may be small
entities: The owners and operators of
vessels intending to transit or anchor in
that portion of the Trent River from 6
p.m. to 8 p.m. on November 12, 2006.
The safety zone will not have a
significant impact on a substantial
number of small entities, because the
zone will only be in place for a few
hours and maritime advisories will be
issued, so the mariners can adjust their
plans accordingly. If you think that your
business, organization, or governmental
jurisdiction qualifies as a small entity
and that this rule would have a
significant economic impact on it,
please submit a comment (see
ADDRESSES) explaining why you think it
qualifies and how and to what degree
this rule would economically affect it.
Assistance for Small Entities
Under section 213(a) of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104–121),
we want to assist small entities in
understanding this proposed rule so that
they can better evaluate its effects on
them and participate in the rulemaking.
If the rule would affect your small
business, organization, or governmental
jurisdiction and you have questions
concerning its provisions or options for
E:\FR\FM\12SEP1.SGM
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Agencies
[Federal Register Volume 71, Number 176 (Tuesday, September 12, 2006)]
[Proposed Rules]
[Pages 53617-53627]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7584]
[[Page 53617]]
=======================================================================
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910, 1915, 1917, 1918, and 1926
[Docket No. H-022K]
RIN 1218-AC20
Hazard Communication
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Advance Notice of Proposed Rulemaking (ANPRM).
-----------------------------------------------------------------------
SUMMARY: OSHA, other Federal agencies, and stakeholder representatives
have participated in long-term international negotiations to develop a
Globally Harmonized System of Classification and Labeling of Chemicals
(GHS). The GHS has been adopted by the United Nations, and there is an
international goal for as many countries as possible to implement the
GHS by 2008. The GHS includes harmonized provisions for classification
of chemicals for their health, physical, and environmental effects, as
well as for labels on containers and safety data sheets (SDS). Adoption
of the GHS by OSHA would require modifications to the Agency's Hazard
Communication Standard (HCS). For example, an order of information
would be established for safety data sheets. In this notice, OSHA is
providing further information about the GHS, the benefits of adopting
it, and its potential impact on the HCS. OSHA is seeking input from the
public on a number of issues related to implementation of the GHS. The
Agency is simultaneously announcing the availability of a new guide on
its Web site at https://www.osha.gov that describes the GHS.
DATES: Comments must be submitted by the following dates:
Hard copy: Your comments must be submitted (postmarked or sent) by
November 13, 2006.
Facsimile and electronic transmission: Your comments must be sent
by November 13, 2006.
ADDRESSES: You may submit comments, identified by OSHA Docket No. H-
022K, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov Follow the
instructions below for submitting comments.
Agency Web Site: https://ecomments.osha.gov Follow the instructions
on the OSHA web page for submitting comments.
FAX: If your comments, including any attachments, are 10 pages or
fewer, you may fax them to the OSHA Docket Office at (202) 693-1648.
Mail, express delivery, hand delivery, and courier service: You
must submit three copies of your comments and attachments to the OSHA
Docket Office, Docket No. H-022K, Room N2625, U.S. Department of Labor,
200 Constitution Avenue, NW., Washington, DC 20210; telephone (202)
693-2350 (OSHA's TTY number is (877) 889-5627). OSHA Docket Office and
Department of Labor hours of operation are 8:15 a.m. to 4:45 p.m., ET.
Instructions: All submissions received must include the Agency name
and docket number (H-022K). Comments received will be posted without
change on OSHA's Web page at https://www.osha.gov, including any
personal information provided. For detailed instructions on submitting
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read comments or background
documents received, go to OSHA's Web page. Comments and submissions are
also available for inspection and copying at the OSHA Docket Office at
the address above.
FOR FURTHER INFORMATION CONTACT: Press inquiries: Kevin Ropp, OSHA
Office of Communications, Room N3647, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
1999. General and technical information: Maureen O'Donnell, Industrial
Hygienist, or David O'Connor, Health Scientist, Directorate of
Standards and Guidance, Room N3718, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
1950.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. History of the OSHA Hazard Communication Standard
B. OSHA's Involvement in Development of the GHS
C. Other OSHA Activities Related to the GHS
D. Benefits of the GHS
E. State Plan States
II. Provisions of OSHA's HCS and the GHS
A. Scope of the GHS
B. Definitions of Hazards Covered
C. Health Hazards
D. Physical Hazards
E. Labels
F. Safety Data Sheets
III. Public Resources for Further Information on the GHS
IV. Request for Input
V. Public Participation
VI. Authority and Signature
I. Background
A. History of the OSHA Hazard Communication Standard
OSHA's Hazard Communication Standard (HCS) (29 CFR 1910.1200;
1915.1200; 1917.28; 1918.90; and 1926.59) was first adopted in 1983 for
the manufacturing sector of industry (48 FR 53280; November 25, 1983).
Later, the Agency expanded the scope of coverage to all industries
where employees are potentially exposed to hazardous chemicals (52 FR
31852; August 24, 1987). The HCS requires chemical manufacturers and
importers to evaluate the hazards of the chemicals they produce or
import. The rule provides definitions of health and physical hazards to
use as the criteria for determining hazards in the evaluation process.
The information about the hazards and protective measures is then
required to be conveyed to downstream employers and employees by
putting labels on containers and preparing and distributing safety data
sheets. All employers with hazardous chemicals in their workplaces are
required to have a hazard communication program, including container
labels, safety data sheets, and employee training. (Note: The HCS uses
the term ``material safety data sheet'' or MSDS, while the GHS uses
safety data sheet or SDS. For convenience, safety data sheet or SDS is
being used throughout this document.)
OSHA has updated estimates in the standard's regulatory impact
analysis, and found that the HCS now covers over 7 million workplaces,
more than 100 million employees, and some 945,000 hazardous chemical
products. Ensuring that hazard and protective measure information is
available in workplaces through hazard communication programs helps
employers design and implement appropriate controls for chemical
exposures, and gives employees the right-to-know the hazards and
identities of the chemicals, as well as allowing them to participate
actively in the successful control of exposures. Together, these
actions of employers and employees reduce the potential for adverse
effects to occur. The information transmitted under the HCS
requirements provides the foundation upon which a chemical safety and
health program can be built in the workplace.
The HCS is performance-oriented, i.e., it establishes requirements
for labels and safety data sheets but does not provide the specific
language to convey
[[Page 53618]]
the information or a format in which to provide it.
B. OSHA Involvement in the Development of the GHS
OSHA's HCS is designed to disseminate information on chemicals to
users to precipitate changes in handling methods and thus protect those
exposed to the chemical from experiencing adverse effects. Since the
United States (U.S.) is both a major importer and exporter of
chemicals, the manner in which the U.S. and other countries choose to
regulate information dissemination on hazardous chemicals not only has
an impact on the protection of employees in the U.S. but also may pose
potential barriers to international trade in chemicals.
To protect employees and members of the public who are potentially
exposed to chemicals during their production, transportation, use, and
disposal, a number of countries have developed laws that require
information about those chemicals to be prepared and transmitted to
affected parties. These laws vary with regard to the scope of chemicals
covered, definitions of hazards, the specificity of requirements (e.g.,
specification of a format for safety data sheets), and the use of
symbols and pictograms. The inconsistencies between the various laws
are substantial enough that different labels and safety data sheets
must often be developed for the same product when it is marketed in
different nations. For example, Canada has established requirements for
labels under its Workplace Hazardous Materials Information System
(WHMIS). WHMIS requires that labels include specified symbols within a
defined circle. U.S. chemical manufacturers must label chemicals
accordingly for marketing in Canada.
Within the U.S., several regulatory authorities exercise
jurisdiction over chemical hazard communication. In addition to OSHA's
HCS, the Department of Transportation (DOT) regulates chemicals in
transport, the Consumer Product Safety Commission (CPSC) regulates
consumer products, and the Environmental Protection Agency (EPA)
regulates pesticides, as well as having other authority over labeling
under the Toxic Substances Control Act. Each of these regulatory
authorities operates under different statutory mandates, and have
adopted varying approaches to hazard communication requirements.
The diverse and sometimes conflicting national and international
requirements can create confusion among those who seek to use hazard
information effectively. For example, labels and safety data sheets may
include symbols and hazard statements that are unfamiliar to readers or
not well understood. Containers may be labeled with such a large volume
of information that important statements are not easily recognized.
Given the differences in hazard classification criteria, labels may
also be incorrect when used in other countries. This is particularly
true with regard to workplace hazard communication in the U.S. Since
the U.S. OSHA system is performance-oriented, labels meeting the
specification requirements of other countries are often seen in the
U.S. workplace. While there are no format requirements in the U.S. that
are violated by these differing formats, the underlying hazard criteria
from another country may be different and that could make the
information on the labels out of compliance with the U.S. HCS.
Development of multiple sets of labels and safety data sheets for
each product when shipped to different countries is a major compliance
burden for chemical manufacturers, distributors, and transporters
involved in international trade. Small businesses may have particular
difficulty in coping with the complexities and costs involved.
When the HCS was first issued in 1983, the preamble included a
commitment by OSHA to review the standard regularly to address
international harmonization of hazard communication requirements. OSHA
was asked to include this commitment in the final rule in recognition
of an interagency trade policy that supported the U.S. pursuing
international harmonization of requirements for chemical classification
and labeling. The potential benefits of harmonization were noted in the
preamble:
* * * [O]SHA acknowledges the long-term benefit of maximum
recognition of hazard warnings, especially in the case of containers
leaving the workplace which go into interstate and international
commerce. The development of internationally agreed standards would
make possible the broadest recognition of the identified hazards
while avoiding the creation of technical barriers to trade and
reducing the costs of dissemination of hazard information by
elimination of duplicative requirements which could otherwise apply
to a chemical in commerce. As noted previously, these regulations
will be reviewed on a regular basis with regard to similar
requirements which may be evolving in the United States and in
foreign countries. (48 FR 53287; November 25, 1983)
OSHA was the only Federal agency that had a public commitment to
pursue harmonization. We have actively participated in a number of such
efforts in the years since that commitment was made, including
participation in trade-related discussions on the need for
harmonization with major U.S. trading partners. The Agency also issued
a Request for Information (RFI) in the Federal Register in January
1990, to obtain input regarding international harmonization efforts,
and on work being done at that time to develop a convention and
recommendation on safety in the use of chemicals at work in the
International Labor Organization (55 FR 2166).
Little progress was made regarding international harmonization
until June 1992, when a mandate from the United Nations Conference on
Environment and Development (UNCED) (Chapter 19 of Agenda 21),
supported by the U.S., called for development of a globally harmonized
chemical classification and labeling system:
A globally harmonized hazard classification and compatible
labelling system, including material safety data sheets and easily
understandable symbols, should be available, if feasible, by the
year 2000.
UNCED further noted that an internationally harmonized system for
transport of dangerous goods was already available. However:
* * * [G]lobally harmonized hazard classification and labelling
systems are not yet available to promote the safe use of chemicals,
inter alia, at the workplace or in the home. Classification of
chemicals can be made for different purposes and is a particularly
important tool in establishing labelling systems. There is a need to
develop harmonized hazard classification and labelling systems,
building on ongoing work.
This international mandate initiated an extensive effort to develop
the GHS. It involved numerous international organizations, many
countries, and extensive stakeholder representation. The work was
managed by the Coordinating Group on the Harmonization of Chemical
Classification Systems, under the umbrella of the Interorganization
Programme for the Sound Management of Chemicals. OSHA chaired the
international coordinating group that managed the harmonization work.
The technical work was divided among several international
organizations. Development of criteria for health and environmental
hazards, as well as mixture classification for chemicals having these
hazards, was done under the auspices of the Organization for Economic
Cooperation and Development (OECD). Criteria for physical hazards were
based on the already harmonized criteria for transportation, and
developed by the United Nations Subcommittee of Experts on the
Transport of Dangerous Goods and the International Labor
[[Page 53619]]
Organization. The overall management of the process, as well as the
work on aspects of the system for communicating hazards on labels and
safety data sheets, were done by the International Labor Organization.
OSHA participated in all of this work, and took the U.S. lead on
classification of mixtures and hazard communication.
The negotiations were extensive and spanned a number of years. The
primary approach involved identifying the relevant provisions in each
of the major existing systems, developing background documents that
compared, contrasted, and explained the rationale for such provisions,
and undertaking negotiations to find an agreed approach that addressed
the needs of the countries and stakeholders involved. The major
existing systems were those of the U.S., Canada, and Europe, and the
United Nations Recommendations for the Transport of Dangerous Goods.
Principles to guide the work were established, including an agreement
that protections of the existing systems were not to be reduced as a
result of harmonization. Thus countries could be assured that the
existing protections of their longstanding systems would be maintained
or enhanced in the resulting harmonized approach.
In the U.S., an interagency committee under the auspices of the
U.S. Department of State coordinated the various agencies involved. In
addition to the four core agencies that have requirements that are
potentially impacted by the GHS, there were a number of other agencies
involved that had interests related to trade or other aspects of the
GHS process. Different agencies had the lead in various parts of the
discussions. Positions for the U.S. in these negotiations were
coordinated through the interagency committee. Interested stakeholders
were kept informed through e-mail dissemination of information, as well
as periodic public meetings. The U.S. Department of State also
published a notice in the Federal Register that described the
harmonization activities, the agencies involved, the principles of
harmonization, and other information, as well as invited public comment
on these issues (62 FR 15951; April 3, 1997). Stakeholders also
actively participated themselves in the discussions in the
international organizations and were able to present their views
directly in the negotiating process.
The product resulting from this effort, the Globally Harmonized
System of Classification and Labeling of Chemicals (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.
While the GHS has been adopted, it is considered to be a living
document that will be updated as necessary to reflect new technology
and scientific developments, or provide additional explanatory text.
OSHA expects to propose adoption of the 2005 version, Revision 1.
Modifications to the GHS that are made after the GHS is adopted in the
U.S. would require additional rulemaking.
It should be noted that the GHS document consists of non-mandatory
recommendations and explanatory text. It is not a model regulation or a
standard that is to be adopted verbatim. Countries like the U.S., and
agencies such as OSHA, will propose converting the recommendations into
appropriate regulatory text consistent with national requirements while
ensuring that the specific provisions are consistent with the GHS and
thus harmonized. OSHA expects to propose modifying the HCS to address
the changes in hazard criteria, adopt the specific labeling
requirements, and adopt the SDS order of information. Other parts of
the framework of the HCS (such as the coverage of articles, trade
secrets, and scope) would likely remain the same.
While the GHS text is available to everyone on the UN Web site, it
will be the proposed rule to adopt the GHS that OSHA plans to issue
rather than the detailed GHS document that will be of primary interest
to U.S. stakeholders. To help those who are not familiar with the
approach in the GHS, OSHA has prepared a guide that summarizes the GHS
requirements, and it is available on our Web site (click on the Hazard
Communication button on https://www.osha.gov). In addition, the Agency
also has a detailed comparison of the HCS to the GHS available on the
Web site so that interested parties can review the types of changes
that would need to be made for the current U.S. workplace requirements
to be harmonized with the international approach.
A review of these differences reveals that the primary impact of
revising the HCS to adopt the GHS would be on compliance obligations
for producers of hazardous chemicals. The modifications to the HCS
would involve a review of the classifications of these chemicals, as
well as preparation and distribution of new labels and revised safety
data sheets. Employers who use chemicals, and exposed employees, would
benefit from receiving the revised labels and safety data sheets
prepared in a consistent format. The information should be easier to
comprehend and access in the new approach, allowing it to be used more
effectively for the protection of employees. The primary change in
workplaces where chemicals are used but not produced will be to
integrate the new approach into the workplace hazard communication
program, including assuring that both the employers and employees
understand the pictograms and other information provided on the
chemicals.
The GHS is now available for worldwide implementation, and
countries have been encouraged to implement the GHS as soon as
possible, with the goal of a fully operational system by 2008. This
goal was adopted by countries in the Intergovernmental Forum on
Chemical Safety, as well as endorsed by the World Summit on Sustainable
Development. In addition, countries involved in the Asia-Pacific
Economic Cooperation have endorsed a goal of 2006. The U.S.
participates in all of these international groups, and has agreed to
working toward achieving these goals.
The U.S. is also a member of both the United Nations Committee of
Experts on the Transport of Dangerous Goods and the Globally Harmonized
System of Classification and Labeling of Chemicals, as well as the
Subcommittee of Experts on the Globally Harmonized System of
Classification and Labeling of Chemicals. These permanent UN bodies
have international responsibility for maintaining, updating as
necessary, and overseeing the implementation of the GHS. OSHA and other
affected Federal agencies actively participate in these UN groups. In
addition, OSHA, EPA and the U.S. State Department also participate in
the GHS Programme Advisory Group that functions under the United
Nations Institute for Training and Research (UNITAR). UNITAR is
responsible internationally 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
interested nations.
C. Other OSHA Activities Related to the GHS
OSHA and the other three core agencies continue interagency
discussions related to coordination of domestic implementation of the
GHS, in addition to ongoing discussions and coordination related to
international work to implement and maintain the GHS.
[[Page 53620]]
OSHA also has ongoing activities related to the GHS under the North
American Free Trade Agreement (NAFTA) discussions on handling of
hazardous substances, and in discussions with the European Union on
issues related to the global management of chemicals.
In addition, a number of organizations with whom OSHA has Alliances
have expressed an interest in hazard communication, and in working
together with each other on the subject. The Alliance program is a
cooperative program that enables organizations committed to
occupational safety and health to work with OSHA to prevent injuries,
illnesses, and fatalities in the workplace (click on the Alliances
button on OSHA's home page for an explanation of the program and a list
of participants). One of the issues they have identified to work
together on is related to the GHS, and making the business case for GHS
adoption, particularly for small businesses. OSHA has conducted a
roundtable of Alliances interested in this topic, and will continue
these meetings to get their input and work with them on products they
identify as appropriate for development. Products under consideration
include a document addressing frequently asked questions and the
corresponding answers, as well as a document that addresses why the GHS
is needed.
D. Benefits of the GHS
Development of this system required extensive work by a great
number of people, and resources from many countries and organizations.
The reason it received such support is that there is a widespread
belief that there are significant benefits associated with
implementation of a globally harmonized approach to hazard
communication. Countries, international organizations, chemical
producers and users of chemicals will all benefit.
First and foremost, implementation of the GHS will enhance
protection of people potentially exposed to chemicals and the
environment. While some countries such as ours already have the
benefits of protection under existing systems, the majority of
countries do not have such comprehensive approaches. Thus
implementation of the GHS will provide these countries with the
important protections that result from dissemination of information
about chemical hazards and protective measures. In our country, we
expect that adoption of the GHS would improve and build on protections
we already have. Refinement of the information provided would help
improve comprehensibility and thus make it more likely that the
information will result in workplace changes to protect employees. As
has already been noted, the majority of affected employers and
employees should benefit from adoption of the GHS through receipt of
better, more standardized, and consistent information about chemicals
in their workplaces.
Secondly, implementation of such an approach would facilitate
international trade in chemicals. It will reduce the burdens caused by
having to comply with differing requirements for the same product, and
allow companies that have not had the resources to deal with those
burdens to be involved in international trade. This is particularly
important for small producers who may be precluded currently from
international trade because of the compliance resources required to
address the extensive regulatory requirements for classification and
labeling of chemicals.
Third, one of the initial reasons this system was pursued
internationally involved concerns about animal welfare and the
proliferation of requirements for animal testing and evaluation. Where
existing systems have different definitions of hazards, it often
results in duplicative testing to produce data related to the varying
levels of toxicity or cut-offs used to define the hazards in the
different systems. Having one agreed definition will reduce this
duplicative testing. It should be noted that OSHA has no testing
requirements. The HCS is based on collecting and evaluating the best
available evidence on the hazards of each chemical.
Information transmittal systems provide the underlying
infrastructure for the sound management of chemicals in a country.
Those countries that do not have the resources to develop and maintain
such a system can use the GHS to build their chemical safety and health
programs. Unlike some other safety and health issues, a country's
approach to the sound management of chemicals definitely affects other
countries. In some cases, bordering countries may experience pollution
and other effects of uncontrolled chemical exposures. In all countries,
there is a need to acquire sufficient information to properly handle
the chemical when it is imported from other countries. Thus having a
coordinated and harmonized approach to the development and
dissemination of information about chemicals will be mutually
beneficial to both importing and exporting countries.
In the U.S., the four primary regulatory agencies (OSHA, EPA, CPSC,
and DOT) that would be responsible for GHS implementation are not
domestically harmonized in terms of definitions of hazards and other
requirements related to classification and labeling of chemicals. Thus,
if all four agencies adopt the GHS, the U.S. would have the additional
benefit of harmonizing the overall U.S. approach to classification and
labeling. Since most chemicals are produced in a workplace and shipped
elsewhere, every manufacturer deals with at least two of the U.S.
systems. Thus every producer is likely to experience some benefits from
domestic harmonization, in addition to the benefits that will accrue to
producers involved in international trade.
OSHA believes that adoption of the GHS could also address some of
the issues that have been discussed in the U.S. regarding the HCS and
its implementation, such as improving labels and SDS comprehensibility
through implementation of a standardized approach. The current
regulatory system includes a performance-oriented approach to labels
and SDSs, allowing the producers to use whatever language or format
they choose to provide the necessary information. This often results in
a lack of consistency that makes it difficult for some users of
chemicals to properly identify the hazards and the protective measures,
particularly when purchasing the same product from multiple suppliers.
Having the information provided in the same words and pictograms on
labels, as well as having a standardized order of information on SDSs,
would help all users identify the critical information necessary to
protect employees.
E. State Plan States
If Federal OSHA promulgates a final rule amending its HCS in
response to the GHS, the 26 States and U.S. Territories with their own
OSHA-approved occupational safety and health plans would be required to
revise their standards to reflect the new amendment within six months
of Federal promulgation. 29 CFR 1953.5(a). A revised State hazard
communication standard must be applicable to both the private and
public (State and local government employees) sectors. Some States may
have statutory provisions that would require amendment in order to
conform to a revised Federal HCS.
Section 18(c)(2) of the OSH Act requires that State standards
applicable to products distributed or used in interstate commerce, if
not identical to the Federal standard, must be required by compelling
local conditions and must not unduly burden interstate
[[Page 53621]]
commerce, in addition to being ``at least as effective'' as the Federal
standard. The amended HCS, like the original standard, would be
`applicable to products' in the sense that it would permit the
distribution and use of hazardous chemicals in commerce only if they
are in labeled containers accompanied by safety data sheets[.]'' 48 FR
53280, 53323, November 25, 1983. In order to assure that State
standards do not pose an undue burden on interstate commerce, and to
advance the goals of the GHS, OSHA would expect to closely scrutinize
resultant State standards to assure not only equal or greater
effectiveness, but also that any different or additional requirements
do not conflict with, or adversely affect, the effectiveness of the
national application of OSHA's standard.
II. Provisions of OSHA's HCS and the GHS
A. Scope of the GHS
The GHS covers chemicals in various stages of their life cycle,
from production to disposal. It is based primarily on the hazards of
chemicals. The GHS is designed to allow regulatory authorities to
choose provisions that are appropriate to their particular scope of
regulation. This is referred to as the ``building block approach.'' The
GHS includes all of the building blocks or possible regulatory
components that might be needed for classification and labeling
requirements in the workplace as well as for regulation of
classification and labeling of pesticides, chemicals in transport, and
consumer products. Therefore, regulatory authorities such as OSHA would
choose the provisions of the GHS that are necessary for the protection
of employees, but would not adopt others that address other types of
protection. For example, the GHS includes harmonized criteria for
classifying chemicals for aquatic toxicity. Since OSHA does not have
the regulatory authority to address environmental concerns, OSHA would
not adopt the GHS criteria for aquatic toxicity. It is expected that
other U.S. agencies that regulate environmental issues will consider
adopting this definition. Similarly, the GHS safety data sheet format
includes a section that addresses environmental information. OSHA would
not require inclusion of environmental information for SDSs used in
workplaces.
The building block approach may also be applied in other ways when
deciding which parts of the system to adopt. For example, the GHS
includes classification criteria, labels, and SDSs. While workplace
authorities such as OSHA are likely to adopt all of these elements, it
is expected that consumer product authorities will not have SDS
requirements, nor will transport authorities. The building block
approach may also be applied to the criteria for defining hazards. For
example, the acute toxicity criteria are much broader than those we
currently have in the HCS for workplace exposures. This is to allow
consumer product authorities the tools they need to address the
protection of children who might accidentally be exposed. OSHA would
not need to adopt all of the categories of acute toxicity in order to
protect employees from the types of exposures they may have.
In addition to the building block approach, the GHS also contains a
number of areas that are left to the competent authority to determine
how to apply the provision. Where OSHA is the competent authority,
i.e., in terms of workplace protections in the U.S., the Agency expects
to maintain its current approaches in terms of interpretations and
accommodations regarding application. These approaches are based on the
rulemaking record, as well as implementation experiences in the U.S.,
and have been determined to be an appropriate application. For example,
the scope and application provisions in the GHS address the interface
of the OSHA requirements to requirements in other agencies that address
the same products. These scope interpretations are expected to be the
same if OSHA adopts the GHS.
Overall, the scope of the GHS with regard to chemicals covered, as
well as types of chemicals and workplaces that are covered, is very
similar to the HCS. The HCS has a very broad scope of coverage,
ensuring that information is provided on all potential hazards in
American workplaces. Adoption of the GHS should maintain this broad
coverage of hazards and chemicals. It should be noted that the GHS,
like the HCS, does not require any new testing of chemicals.
Evaluations of chemical hazards are to be based on the best available
evidence.
As has been described above, the HCS consists of requirements for
defining health and physical hazards, preparing a written hazard
communication program, preparing and distributing labels on containers
that are shipped as well as containers in the workplace, preparing and
distributing safety data sheets for all hazardous chemicals, and
employee training. The GHS addresses classification of health and
physical hazards, and preparation and distribution of labels and safety
data sheets. It does not include requirements for a written hazard
communication program or for employee training. Training is noted in
the GHS as an important adjunct to label and safety data sheet
requirements, but the harmonization process did not include such
provisions. Countries are thus free to determine what training will be
applicable in their own regulatory approach. OSHA believes that
training is critical to ensuring the effectiveness of hazard
communication, and anticipates maintaining current HCS requirements
that training be part of a hazard communication program. OSHA also
expects to propose some additional training to ensure understanding of
the new approach regarding labels and SDSs in the GHS.
B. Definitions of Hazards Covered
The HCS covers a broad range of both health and physical hazards.
The standard is performance-oriented, providing definitions of hazards
and parameters for evaluating the best available evidence to determine
whether a chemical has a hazardous effect under the standard. In
particular, with regard to health hazards, one toxicological study,
conducted according to established scientific principles and reporting
a statistically significant adverse health effect, is sufficient for a
finding of hazard under the rule. The principle behind the standard is
that it is to address dissemination of information, and thus complete
information about all of the potential hazards should be disseminated
to ensure that employers and employees can make appropriate decisions
about the level of protection required in their particular workplaces.
Hazard information, in combination with information about the exposures
occurring in each workplace, allows decisions to be made by employers
regarding the appropriate risk management to implement based on the
specific conditions in their workplace. Chemical manufacturers and
importers do not have information about the exposures to their products
in each workplace where their product may be used, so they must prepare
their labels and safety data sheets based on the hazards of the
chemicals.
C. Health Hazards
The HCS thus covers every type of health effect that may occur,
including both acute and chronic effects. The standard describes
different systems of the body and indicates that target organ effects
are to be considered in the hazard evaluation. The definitions provided
are indicative of the wide range of coverage, but are not exclusive.
[[Page 53622]]
Any type of adverse health effect that is reported and substantiated by
a scientific study is covered. The standard specifically includes the
following in the definition of ``health hazard'':
Carcinogens
Toxic or highly toxic agents (all routes of entry)
Reproductive toxins
Irritants
Corrosives
Sensitizers
Hepatotoxins
Nephrotoxins
Neurotoxins
Agents which act on the hematopoietic system
Agents which damage the lungs, skin, eyes, or mucous membranes
The GHS also has a very broad approach to the range of health
effects covered:
Acute toxicity (any route of entry)
Skin corrosion/irritation
Serious eye damage/eye irritation
Respiratory or skin sensitizer
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
Specific target organ systemic toxicity--single exposure
Specific target organ systemic toxicity--repeated use
Aspiration hazard
Under the GHS, each hazard or endpoint as listed above is considered to
be a hazard class. The classes are generally sub-divided into
categories of hazard. The definitions of hazards are much more specific
and detailed than what is in the HCS. For example, under the HCS, a
chemical is either a potential carcinogen or it is not. The evaluation
is a yes or no response. Under the GHS, there are two categories of
carcinogenicity, based on the weight of the evidence involved. The
hazard communication consequences of this classification also vary as a
result for each category in a hazard class. The hazard communication
elements allocated to each category reflect the degree of severity of
the hazard.
There are advantages to this more specific and delineated approach.
First, the detailed criteria for classification should lead to more
accurate hazard determinations and more consistency among multiple
classifiers. There is less likely to be room for different
interpretations of the same data. This addresses some of the concerns
that have been raised about the HCS. In addition, introducing
categories gives an indication of the degree of severity of the hazard.
This is helpful to employers and employees determining what the
appropriate course of action should be when exposures to the chemical
occur.
There may be some changes in what the hazard of certain chemicals
is determined to be based on a consideration of the data available on a
chemical in light of these new criteria. It is expected that chemical
manufacturers and importers will be required to re-evaluate their
chemicals according to the GHS criteria. But given the current broad
nature of the HCS, it is not expected that the number of chemicals
covered would change in any significant way. The most likely difference
would be that the chemical may be characterized in categories for
certain hazards based on the weight of the evidence.
With regard to mixtures of chemicals, the HCS requires the
evaluation of mixtures to be based either on data for the mixture as a
whole, or, where that is not available, the mixture's health hazards
are to be based on the presence of ingredients with health hazards over
a specified percentage. That percentage is 0.1% for carcinogens, and
1.0% for all other types of health effects. The HCS also recognizes
that risk may remain below these cut-offs, and where there is evidence
that is the case, the mixtures are still covered.
The GHS has what has been described as a tiered approach to mixture
evaluation. The first step is consideration of data on the mixture as a
whole, similar to the HCS. The second step allows the use of ``bridging
principles'' to estimate the hazards of the mixture based on
information about its components. For example, if a chemical is
considered to be acutely toxic, but it is diluted with something that
is not toxic, the GHS allows the employer to take the dilution into
consideration when evaluating the hazards of the product rather than
simply basing it on a percentage cut-off approach like the HCS. This
extrapolation of data will mean that fewer mixtures will be evaluated
on the basis of the presence of a chemical above a specific cut-off.
The third part of the tiered approach does involve cut-offs, but they
vary by the type of effect. In particular, for acute effects, there is
a formula for determining whether the mixture is considered to be
toxic. The formula is based to some extent on one that is currently
used in transport.
Overall, the approach is generally consistent with the current HCS
requirements, but provides more detail and specification and allows
more extrapolation of data available on the components of a mixture--
particularly for acute effects. It is thus more complicated than the
approach in the HCS, and it is likely that additional guidance,
particularly electronic tools, may need to be made available to assist
with compliance.
As a result of these differences in health hazard criteria and the
accompanying approaches to classifying mixtures, another provision of
the standard that is potentially impacted by adoption of the GHS is the
process of hazard determination. Under the current rule, this process
is performance-oriented, allowing for a significant degree of
professional judgment on the part of the hazard evaluator. No specific
procedures are provided, but there are certain parameters established.
The scientific literature must be reviewed, and if there is at least
one toxicological study, conducted according to established scientific
principles, and providing statistically significant results indicating
an adverse health effect, this hazard must be disclosed under the HCS.
The HCS also includes references to sources of information that
were identified in the rulemaking record as one basis for making an
initial determination of hazard. Among these listed sources are OSHA's
substance-specific standards (those chemicals for which OSHA has
promulgated a permissible exposure limit (PEL) in Subpart Z, Toxic and
Hazardous Substances), American Conference of Governmental Industrial
Hygienists (ACGIH) Threshold Limit Values (TLVs), International Agency
for Research on Cancer (IARC) monographs, and the National Toxicology
Program (NTP) list of carcinogens. These sources provide employers a
list of hazardous chemicals. However, manufacturers and importers are
still required to review the available information to determine
specifically what the hazards of these chemicals are, and to disclose
them on labels and safety data sheets.
The GHS provides much more specific criteria for defining health
hazards than the HCS does. If OSHA adopts the GHS, these more specific
criteria will be part of the HCS. This will eliminate the need for a
specific listing of hazardous chemicals as part of the hazard
determination procedures. Chemical manufacturers and importers are much
more likely to make consistent hazard determination evaluations
following the specific criteria in the GHS, thus addressing the
concerns that led to the inclusion of lists in the original Hazard
Communication Standard. References to the chemicals for which there are
ACGIH TLVs, and those chemicals addressed in IARC Monographs and the
NTP lists, would no longer be specifically addressed in the HCS.
Chemical manufacturers and importers would retain the
[[Page 53623]]
responsibility for evaluating all relevant data on the chemicals they
produce or import.
Similarly, the provisions for disclosing the hazardous ingredients
of mixtures under the GHS are much more detailed than the HCS. The
simple across-the-board cut-offs for all types of hazards would no
longer be part of the rule if it is changed to adopt the GHS. Modifying
the HCS to align with the GHS would also eliminate the current
references to ACGIH TLVs as part of the mixture provisions.
D. Physical Hazards
With regard to physical hazards, the current definitions in the HCS
are drawn from other standards we have that address such chemicals
(e.g., flammable chemicals), or from what were the DOT criteria for
physical hazards at the time OSHA promulgated the HCS. OSHA includes
definitions for the following physical hazards in the HCS:
Combustible liquid
Compressed gas
Explosive
Flammable (aerosol, gas, liquid, solid)
Organic peroxide
Oxidizer
Pyrophoric
Unstable (reactive)
Water-reactive
The GHS includes criteria for the following physical hazards:
Explosives
Flammable (aerosol, gas, liquid (including combustible liquid),
solid)
Oxidizing (liquids, solids, gases)
Gases under pressure
Self-reactive substances and mixtures
Pyrophoric (liquid, solid)
Self-heating substances and mixtures
Substances and mixtures which in contact with water emit flammable
gases
Organic peroxide
Corrosive to metals
DOT subsequently changed their criteria to be consistent with the
international transport requirements. The international transport
requirements for classification of physical hazards have now been
incorporated into the GHS. While DOT must make a few changes to be
consistent with the GHS, their requirements are mostly already the
same.
OSHA is not harmonized with current DOT requirements. Changing the
HCS to adopt the GHS criteria would also ensure that DOT and OSHA
requirements are consistent. This is an important improvement in the
current situation where the outside of a truck may be placarded with a
different hazard than the workplace labels convey on the containers
inside the truck. Again, chemical manufacturers and importers would
have to re-evaluate their chemicals according to the new criteria in
order to ensure they are classified appropriately. However, if they are
chemicals that are transported, i.e., not produced and used in the same
workplace, this classification should largely be done already for
purposes of complying with DOT's existing transport provisions. This
should minimize the additional work required to review the physical
hazard classifications to be consistent with the GHS for purposes of
workplace classification and labeling.
One issue of concern is whether OSHA should also propose to change
the physical hazard definitions in other standards when it proposes to
change the HCS criteria to be consistent with the GHS. For example, if
the HCS definitions are changed with regard to the definition of
flammable liquids, there is a concern as to whether definitions in the
flammable liquids standard need to be changed as well, and what the
impact of this would be beyond classification and labeling. This is one
of the areas that needs to be further explored in terms of impact and
possible consequences.
E. Labels
The HCS requirements for labels simply indicate the minimal
information required to be on them. At the time the standard was
promulgated, OSHA reviewed the current industry consensus standards for
labels, and basically focused on requiring information that was not
generally present on most labels in use by industry. The additional
information included an identity that could be traced to more detailed
information, and specific information about both the health and
physical hazards. In particular, OSHA did not consider a label
statement indicating possible harm but no specific health effect to be
a sufficient hazard communication. Other types of information such as
precautionary statements were not included in the requirements.
This performance-oriented approach was strongly supported by the
chemical industry at the time the standard was adopted. Taking such an
approach allowed existing labels to continue to be used in many
situations, thus minimizing the impact on a number of producers.
However, it also has resulted in labels that are not consistent,
and may not communicate adequately to users. While some producers
follow voluntary industry consensus standards, others do not. Many
large companies have developed their own libraries of phrases to be
used on labels and safety data sheets, and undertaken translation of
them into multiple languages. This is a considerable burden for a
company to develop and maintain.
Other major existing systems considered in the harmonization
process included specific label phrases to convey hazards and other
information. Symbols and pictograms were also part of these systems.
For purposes of developing an agreed harmonized approach, it was thus
necessary to consider including such elements in the GHS.
For each class and category of hazard under the GHS that OSHA is
considering adopting, there is a harmonized hazard statement, a signal
word, and a pictogram specified. This is referred to as the core
information for a chemical. Thus once an employer classifies a
chemical, the GHS provides the specific core information to convey to
users on that chemical. There are provisions to allow supplementary
information as well so the chemical manufacturer is not limited to the
specified core information. This should address product liability
concerns for U.S. employers and ensure they can include other
information they consider to be necessary for that purpose.
Precautionary statements are also provided as examples in the GHS, but
they have not yet been agreed and harmonized. This is expected to occur
in the future as work on the system continues. Figure 1 is an example
of how the core labeling elements (harmonized hazard statement, signal
word, and pictogram) are assigned in one hazard class covered under the
GHS.
These labeling provisions will likely be the biggest difference
between the HCS and the GHS. There are benefits to this standardized
approach. First, employers and employees will be given the same
information on a chemical regardless of the supplier. This consistency
will 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. Literacy of both
types is a significant concern in American workplaces. Secondly, having
the core information developed already, translated into multiple
languages, and readily available to whomever wishes to access it, will
eliminate the burden of chemical manufacturers and importers developing
and maintaining their own such systems. Thus the specification approach
should be beneficial both to
[[Page 53624]]
the producers and the users of chemicals.
[GRAPHIC] [TIFF OMITTED] TP12SE06.019
United Nations Globally Harmonized System of Classification and
Labeling of Chemicals, First Revised Edition, 2005, Annex I. Diamond
frames for pictograms in the top row are red.
The use of symbols and pictograms will require some training and
familiarization to be effective. One of the issues OSHA is considering
is whether generic training on this aspect of the GHS can be developed
and made available to employers and employees.
There is another significant benefit that will be achieved by
adopting a system that has harmonized hazard statements in it.
``Control banding,'' a guidance approach to recommending control
measures for chemical exposures, is attracting significant attention
around the world. The approach uses information that is readily
available to small and medium-sized employers with chemicals in their
workplaces to provide them with workplace-specific control
recommendations. Basically, the system uses such information to
estimate the degree of severity of the hazard and the amount of
chemical present, and relates that to the degree of control needed. The
control banding approach relies on harmonized hazard statements to
allow the system to estimate the degree of severity of the hazard.
Initially based on the European hazard classification system, it has
now been converted to the GHS phrases. The use of control banding to
provide guidance for chemical safety and health approaches in U.S.
workplaces cannot be accomplished until harmonized hazard statements
are readily available. Adoption of the GHS and its phrases would open
up the possibility that control banding guidance can be used in the
U.S. to help small and medium-sized employers select and implement
appropriate control measures. In addition, the possibility of
addressing control banding recommendations in GHS SDSs in the section
on controls is also being explored. For more information on control
banding, please see https://www.cdc.gov/niosh/topics/ctrlbanding/.
F. Safety Data Sheets
Under the HCS, the SDS is the detailed reference source on the
chemical. While labels provide a quick snapshot to remind employers and
employees of the hazards of the chemical, the SDS addresses all aspects
of hazard information as well as methods for handling and use. The HCS
specifies what information must be included on the SDS, but does not
specify a format or order of information. Again, this approach was
supported by producers to minimize the impact of the standard for those
who already developed and disseminated SDSs. Currently, safety data
sheets under the HCS are required to include:
Identification of the chemical or hazardous ingredients of a mixture
Physical and chemical characteristics
Health hazards, including signs, symptoms, and medical conditions
that could be aggravated by exposure
The primary routes of entry
The OSHA permissible exposure limit, ACGIH Threshold Limit Value,
and any other recommended exposure limits
Whether the chemical is considered to be a carcinogen by OSHA, the
International Agency for Research on Cancer, or the National
Toxicology Program
Precautions for safe handling and use
Control measures
Emergency and first aid procedures
[[Page 53625]]
Date of preparation of the safety data sheet
Contact information for the responsible party
Users of chemicals have always preferred a standardized approach.
Many believe that having the information in the same place on every
data sheet allows them to access it more effectively. OSHA published a
request for information regarding ways to improve the information
provided under the HCS (55 FR 20580; May 17, 1990), and received around
600 comments in response. The majority of them were in favor of a
standardized format or order of information.
As a result of the users' expressed preferences, chemical
manufacturers in the U.S. developed a voluntary industry consensus
standard that included an order of information for safety data sheets
(ANSI Z400.1). This approach was later adopted into international
voluntary industry consensus standards as well.
The HCS allows any format to be used, so many producers have been
following the consensus standard order of information for some years.
In negotiating the GHS, it was decided that this format should be
adopted there as well. One change was made, reversing the order of
sections 2 and 3 so the hazard information appeared earlier in the
sheet than information on chemical composition. Both the national and
international industry consensus standards are being changed to be
consistent with this approach. The GHS data sheet is to include the
following in this order:
Identification
Hazard identification
Composition/information on ingredients
First aid measures
Firefighting measures
Accidental release measures
Handling and storage
Exposure controls/personal protection
Physical and chemical properties
Stability and reactivity
Toxicological information
Ecological information
Disposal considerations
Transport information
Regulatory information
Other information
Having a standardized order of information should improve
comprehensibility, which has been a continuing issue with regard to
safety data sheets. It should also make it easier for chemical
producers to comply by providing them with a template to follow. Using
the industry consensus standards should also minimize the burden of
preparing new safety data sheets since many chemical producers already
use the format specified. While the GHS safety data sheet does not
address exposure limits in the titles of the sections, guidance on what
should be included indicates that occupational exposure limits would be
addressed under the ``exposure controls'' section. Countries may choose
what to require in these sections in terms of occupational exposure
limits, but it is anticipated that OSHA would require the PELs to be
included.
Under the auspices of the International Program on Chemical Safety
(IPCS), a series of over 1300 international chemical safety cards has
been developed and translated into 14 languages. These cards are
developed and peer reviewed by participating institutions in a number
of countries, including the U.S. The National Institute for
Occupational Safety and Health (NIOSH) is undertaking this work. The
cards are similar to SDSs in terms of the information provided, but
they are in a concise format of two pages. The cards are going to be
updated to reflect the GHS criteria and hazard information. They may be
found on NIOSH's Web page at: https://www.cdc.gov/niosh/ipcs/
nicstart.html OSHA also has a link to them on our hazard communication
page. These cards are an excellent resource for many of the most common
chemicals found in the workplace. When updated to be GHS-consistent,
they will also be a useful resource for GHS compliance and for
implementation of control banding.
As mentioned earlier, there is information required on a GHS SDS
that is outside OSHA's jurisdiction to regulate. This includes
environmental and transport information. We do not intend to propose
requiring it on safety data sheets, but will provide information about
the provisions so chemical producers can include it if they wish to be
completely consistent with the GHS. OSHA does not preclude such
information being on a safety data sheet, but will not review or
enforce such provisions.
III. Public Resources for Further Information on the GHS
OSHA has a safety and health topic page on hazard communication
available as part of our Web site. There is a hazard communication
button on the Agency's home page (https://www.osha.gov) that leads to a
portal page on the topic, including a box on the GHS. There is a page
devoted to the GHS that is reached through clicking on this box. It
gives additional background information, and has links to the GHS
official text, Web pages of other U.S. agencies, international
organizations, and countries involved in GHS implementation.
As noted earlier, a substantive guide to the GHS is available on
this page to describe the system in more detail for those who are
interested. There is also a detailed comparison of the HCS to the GHS
that notes the areas of difference that would have to be addressed in
adopting the GHS.
IV. Request for Input
In order to prepare for rulemaking proposing adoption of the GHS
and modification of the HCS to accomplish that, OSHA is seeking input
from the public on a number of issues related to implementation. This
information will be used by OSHA to prepare cost analyses and other
documents required to support the rulemaking. These requests are
divided into several categories of information below. Please provide
comments, evidence, data, and other input for those categories that
affect you or for which you have relevant information. The details for
submitting this information are specified in Section V.
Current situation. Modifying the HCS to adopt the GHS would have
the greatest impact on chemical manufacturers, importers, and employers
who produce or distribute hazardous chemicals as currently covered
under the HCS. In order to be harmonized, the hazard classifications of
each product will need to be reviewed according to the classification
criteria of the GHS, and new labels and safety data sheets will have to
be prepared.
1. How many hazardous chemicals as defined by the HCS do you
produce, import or distribute? How many hazardous chemicals do you
export? How many different labels or data sheets do you need to prepare
for each chemical you export?
2. Who is responsible for reviewing the data on chemicals and
preparing appropriate labels and safety data sheets? What is their
professional background? Do you make independent determinations or rely
largely on labels or data sheets developed by others (suppliers,
materials available on the Internet, etc.)?
3. How long does it take on average for each hazardous chemical to
complete the review and prepare new labels and safety data sheets? How
much does it cost for each chemical product? Please break down the cost
for the classification, preparation of a new label, and revision of a
safety data sheet.
4. Would the time required to prepare a GHS SDS be more, less, or
about the same as currently required for preparing an SDS? What time
and costs would be required to convert existing SDSs to the
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GHS format? Would the costs depend on the amount of time allowed for
the conversion process?
5. Please describe any electronic tools you have to assist with
this process, such as systems that classify chemicals or prepare labels
or safety data sheets. How long would it take to update those systems
to make them GHS-consistent?
6. How many of your employees receive hazard communication
training? How many hours of training at what frequency (on hire,
annually, as needed, etc.)? How long would it take to teach employees
to recognize GHS pictograms? Would more standardized labels and SDSs
make it easier to use the available hazard communication information?
7. What savings will you incur when you only have to classify a
chemical once instead of multiple times depending on how many agencies
and countries are involved? What other benefits do you anticipate?
Timing. As has been noted, the international goal is for as many
countries as possible to adopt the GHS by 2008. Since OSHA has
longstanding requirements for labels and safety data sheets, the Agency
expects to allow a significant phase-in period for compliance in order
to give people sufficient time to review their classifications and
amend them as necessary, and subsequently revise labels and safety data
sheets to reflect the new requirements. It seems probable at this point
that the revised requirements could potentially be in place by 2008,
but the phase-in period for compliance may have to extend beyond that
time period.
8. What is a reasonable time period for phasing in the
modifications? Should the phasing be done by size of business? Are
there any other factors that should be considered to differentiate the
phasing?
9. What is the normal cycle for updating labels and safety data
sheets?
10. Do you have stockpiles of product that are already labeled? How
long will those stockpiles last?
11. Do you have any other information or data that would help OSHA
determine the appropriate phasing in of the new requirements or other
issues related to timing?
Technical issues. As discussed, the scope of hazards covered by the
GHS is similar to that of the HCS. OSHA anticipates adopting all of the
health and physical hazard criteria in the GHS. Definitions in the HCS
will need to be the same as the GHS in order to be harmonized. However,
there are some determinations that are left to countries to decide in
terms of whether all categories and all hazards are adopted.
12. Are there any health or physical hazards that are currently
covered by the HCS that you think are not adequately addressed in the
GHS criteria? What are they and why do you think they are not
adequately addressed? Are there any health or physical hazards that
aren't covere