[Federal Register Volume 62, Number 64 (Thursday, April 3, 1997)]
[Notices]
[Pages 15951-15957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8505]
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DEPARTMENT OF STATE
[Public Notice 2526]
Bureau of Oceans and International Environmental and Scientific
Affairs; International Harmonization of Chemical Safety and Health
Information
AGENCY: Bureau of Oceans and International Environmental and Scientific
Affairs (OES); Department of State.
ACTION: Notice regarding Government activities on international
harmonization of chemical safety and
[[Page 15952]]
health information, and request for comments and information.
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SUMMARY: Under the auspices of the State Department, an interagency
committee has been working with international organizations and other
countries to pursue harmonization of existing regulatory requirements
or recommendations for chemical safety and health information. The
authority for the State department, OES Bureau to convene this
interagency committee is set forth at 22 U.S.C. 2655a. This includes,
for example, provisions for classifying chemicals regarding their
hazards, and the preparation and dissemination of information about the
hazardous chemicals and appropriate safe handling procedures for them
through labels, placards, material safety data sheets, or other written
materials. Such requirements currently exist in the United States in
laws or regulations that address worker protection, consumer
protection, transportation of hazardous materials, and environmental
protection.
Harmonization of such requirements internationally has been a long-
term goal for the United States Government (USG). It was initiated
through a 1984 interagency policy on chemical labeling trade issues.
This goal became global through an international mandate in 1992 as a
result of agreements made by participating countries, including the
United States, in conjunction with the United Nations Conference on
Environment and Development (UNCED) in 1992. Specifically, the UNCED
objective states: ``A globally harmonized hazard classification and
compatible labeling system, including material safety data sheets and
easily understandable symbols, should be available, if feasible, by the
year 2000.'' Recently, countries reaffirmed this commitment at a
meeting of the Intergovernmental Forum on Chemical Safety, and
recommended that the system be implemented in a voluntary instrument.
The purpose of this notice is to update the public on progress made to
date, and to allow an opportunity for interested parties to provide
comments that may assist USG representatives as well as representatives
of stakeholder groups such as industry, labor, and environment, who
participate in the international discussions on these issues.
DATE: Comments and information should be submitted by June 2, 1997.
ADDRESS: Comments and information are to be submitted in quadruplicate
or 1 original hard copy and 1 disk (3\1/2\ inch) in Word Perfect 5.1,
6.1, or ASCII text to: Office of Environmental Policy, Attn: David
Rabadan, U.S. Department of State, OES/ENV Room 4325, 2201 C Street,
NW, Washington, DC 20520.
FOR FURTHER INFORMATION CONTACT:
1. For general information related to this notice: David Rabadan,
Office of Environmental Policy, U.S. Department of State, OES/ENV Room
4325, 2201 C Street, NW, Washington, DC, 20520; Telephone: (202) 647-
8772; FAX: (202) 647-5947; E-mail: [email protected]. After May 30,
OES/ENV contact will be Trigg Talley. Telephone: (202) 647-9266; FAX:
(202) 647-5947.
2. For information about activities of the Interorganization
Programme for the Sound Management of Chemicals' (IOMC) Coordinating
Group for the Harmonization of Chemical Classification Systems:
Jennifer Silk, Directorate of Health Standards Programs, Occupational
Safety and Health Administration, 200 Constitution Avenue, NW, Room
N3718, Washington, DC, 20210; Telephone: (202) 219-7056; FAX: (202)
219-7068; E-mail: [email protected].
3. For information about activities of the Organization for
Economic Cooperation and Development's (OECD) Advisory Group on
Harmonization: Amy Rispin, Office of Pesticide Programs, Environmental
Protection Agency, Washington, DC, 20460; Telephone: (703) 305-5989;
FAX: (703) 305-6244; E-mail: [email protected].
4. For information about activities of the United Nations'
Committee of Experts on the Transport of Dangerous Goods' (UNCETDG)
activities related to harmonization: Frits Wybenga, Research and
Special Programs Administration, Department of Transportation, 400 7th
Street, SW, Washington, DC, 20590, Telephone: (202) 366-0656; FAX:
(202) 366-5713; E-mail: [email protected].
SUPPLEMENTARY INFORMATION:
Background
It has been estimated that there are as many as 650,000 hazardous
chemical products in distribution in the United States (59 FR 6126).
The potential hazards of these chemical products cover a wide range of
health, physical and environmental effects. The health hazards that may
result from exposure to these chemicals can be relatively minor, such
as simple irritation of the skin, eyes, or respiratory tract, or may be
serious and lethal, such as carcinogenicity or death from acute
toxicity. Physical hazards include such characteristics as flammability
and reactivity. Environmental hazards may cause aquatic, terrestrial or
atmospheric effects. A number of federal laws, standards and
regulations have been adopted to ensure adequate protection of the
environment, workers handling the chemicals at various stages in the
distribution chain, and members of the public (including consumers and
emergency response personnel) who are potentially exposed to the
chemicals during transportation and use. In certain areas, state and
local laws supplement federal regulations.
Given the number of chemicals involved, and the limited resources
available to address them on an individual basis, many of the U.S. laws
are generic, focusing on generating and providing information regarding
the hazards and precautions for safe use of chemicals rather than
developing substance-specific regulations, such as exposure limits, for
each one. The first step in each of these information-based regulatory
schemes is the classification of chemicals according to their hazards.
This requires development of definitions of hazards, and a means to
evaluate information available on a chemical to classify it with regard
to its hazard potential (e.g., what type of data are needed to classify
the chemical, what test methods must be followed). The rules then
require the generation and distribution of information on the hazardous
chemical. The required information is generally given to handlers and
users of the materials (such as workers, consumers, transport workers,
and emergency response personnel) by means of labels, placards,
materials safety data sheets, or other written materials regarding the
hazardous chemicals. Training may also be required to ensure that those
receiving this information can use it appropriately to protect
themselves. Provision of complete information allows users and handlers
to employ proper protective measures to avoid the occurrence of adverse
effects.
It should be noted that this effort to develop a globally
harmonized system (GHS) is limited to hazard classification and
associated information transmittal requirements. The GHS should be
viewed as a collection of building blocks from which the appropriate
blocks for a particular part of a regulatory system can be chosen. For
example, the system must include criteria for both chronic and acute
health effects. However, that does not mean that all of the available
criteria will be applied in all parts of the U.S. regulatory system. It
may be expected, for example, that chronic health hazard criteria would
not need to be applied to the transport sector because exposures
[[Page 15953]]
are brief and concerns are primarily directed to emergency situations.
Application of the harmonized criteria will be consistent with the
current U.S. approaches to regulation in various sectors. There are
also situations where regulatory agencies already examine risk and
determine that products are safe for use despite the small presence of
small quantities of a hazardous chemical. These may include, for
example, food which has trace amounts of a food additive or pesticide
residue. While these types of chemicals may be hazardous in larger
quantities when handled by workers, and are at that point subject to
hazard classification requirements, a determination has been made by
the government that they are safe for human consumption in their final
finished form. They are not subject to hazard classification and
labeling at that point in the product's life cycle, and thus the
harmonized system will not be applied to them when completed.
Classification criteria refer to test data in establishing the
parameters of coverage, but the GHS will not be establishing a testing
protocol for chemicals or a testing system for countries to adopt. It
is expected that varying test methods can be used as long as good
laboratory practices are applied, and the approach is scientifically
defensible with statistically significant results. The GHS will also
not address downstream risk management decisions, such as packaging
requirements or restricting the use of a chemical. Generally speaking,
a hazard classification system is not appropriately used for such
purposes without some further consideration of risks.
Other countries and international organizations have also adopted
requirements to provide information to workers and members of the
public potentially exposed to hazardous chemicals. In 1992, the
International Labor Organization (ILO) published the Report on the Size
of the Task of Harmonizing Existing Systems of Classification and
Labeling for Hazardous Chemicals. In this report, the ILO indicated
that there are two systems in addition to that in the U.S. which have a
broad impact globally, and are of major significance to workers and
consumers, or users of the chemicals. The European Union (EU) has
directives which address classification and labeling of substances and
preparations, and material safety data sheets. Canada has also adopted
rules, most notably one which requires labels and material safety data
sheets for chemicals in the workplace (Workplace Hazardous Materials
Information System (WHMIS)). Other countries such as Australia, Japan,
and Switzerland, have also adopted systems to protect workers and
consumers.
In the area of transport, many countries' authorities, including
the U.S. Department of Transportation (USDOT), follow the
recommendations of the United Nations' Committee of Experts on the
Transport of Dangerous Goods (UNCETDG). This UN Committee has developed
harmonized criteria for hazard definitions and labeling that are
applied in the transport sector throughout the world. These definitions
focus on physical hazards, and acute health hazards.
Thus, according to the ILO Report, there are four major existing
systems that have to be addressed in any effort to develop a harmonized
scheme--those of the United States, Canada, the EU, and the UN
transport system. While all of these systems are similar in intent
(i.e. they are designed to protect people from experiencing adverse
effects), there are significant differences in the specific provisions
with regard to the criteria used to classify the chemicals, and the
warning phrases, symbols, or other hazard communication components used
to convey the information. Therefore, a chemical in the United States
may be classified as being flammable for purposes of transport, but not
for workplace use. Or it may be considered carcinogenic in the United
States, but not in the EU.
The result is a patchwork of conflicting and diverse national and
international requirements. Because of the variations in classification
criteria, the same chemical may be classified as having different
degrees of hazard, and thus require different warning statements,
depending on the classification system being applied in a given
situation. The differences multiply when the warning statements
themselves are considered. Symbols and terminology vary from system to
system.
The proper protection of the public from the hazards of imported
chemicals is a primary concern. Consistency in approach, and provision
of complete information will eliminate the confusion that users may
experience as a result of receiving conflicting or incomplete data.
This confusion can ultimately jeopardize safety; harmonized
requirements will, therefore, help ensure that chemicals imported into
the U.S. can be used as safely as those which are produced domestically
within our borders.
To market or ship a product internationally, companies must grapple
with different regulatory systems and attempt to develop labels and
material safety data sheets to satisfy the varying requirements.
Currently, that generally means having at least three sets of labels
and data sheets for the same product when it is marketed in the U.S.,
Canada and the EU. There are also other countries that may have
different requirements (e.g., Japan). This multiplicity of requirements
creates a difficult compliance burden, and one which small companies in
particular are not well equipped to handle due to the complexities
involved and the extensive costs. These differing requirements may,
therefore, constitute a technical barrier to trade, and are problematic
for companies wishing to export chemicals from the United States. Small
companies may be effectively barred from international trade by their
inability to deal with the various classification requirements. These
barriers to participation in international trade would be effectively
eliminated by a globally harmonized system, and the costs of compliance
with varying international requirements would be significantly reduced.
Other benefits that could result from harmonization include a
reduction in the need for animal testing. The criteria used to classify
hazards generally refer to the type of test methodology to follow in
creating the data for purposes of classification. If all systems use
the same criteria and acceptable test methodologies, there will be no
need to test the same chemical several times for compliance with the
differing requirements of the various systems. Centralized maintenance
of the globally harmonized system (e.g., updating criteria based on new
scientific information) by an international group would also reduce the
efforts currently undertaken by the various countries and organizations
maintaining different systems, thus freeing limited resources to
address other problems.
Additional benefits will accrue in the U.S. since adoption of a
globally harmonized system will also result in domestic harmonization.
Currently in the U.S., various agencies promulgate requirements for
hazard classification and information dissemination for the same
chemicals, but may do so in different ways. This is due in part to the
varying statutory requirements under which they operate. The result is
that there is confusion among chemical users, thus reducing the utility
of the information and the potential for protection. It also creates
compliance burdens for manufacturers and importers who must classify
their products under more than one agency's regulatory requirements.
While international harmonization is the
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primary focus, the resulting domestic harmonization potentially affects
many more producers and users of chemicals in the U.S. Harmonization of
U.S. agency requirements would streamline the Federal approach to
hazard classification and labeling, resulting in increased protections
for users and reduced compliance burdens.
Interagency Activities
As mentioned at the outset, the State Department coordinates an
interagency work group to develop the United States' position
concerning international harmonization of chemical safety and health
information. Members of the committee include all of the agencies that
regulate in this area: Consumer Product Safety Commission (CPSC),
Department of Transportation (DOT), Environmental Protection Agency
(EPA), Food and Drug Administration (FDA), Occupational Safety and
Health Administration (OSHA), and the Food Safety and Inspection
Service (FSIS) of the U.S. Department of Agriculture (USDA). Other
agencies that are interested or involved in trade and policy aspects of
the issue participate as well, including other regulatory agencies and
the Department of Commerce and the Office of the U.S. Trade
Representative.
This interagency work group has been meeting for a number of years
to discuss issues related to harmonization, to share information on
work being conducted in various international fora, and to develop a
coordinated U.S. policy regarding the international harmonization
activities. In order to facilitate the work and ensure a coordinated
position, a U.S. Government policy paper on harmonization of chemical
safety and health information was developed by the interagency group in
1992. As part of that process, principles of harmonization were adopted
to guide the participation of the various agencies in the U.S.
Government in the international harmonization process. (See Table 1).
Table 1.--U.S. Government Agencies' Guiding Principles for Harmonization
of Chemical Safety and Health Information
1. The overall goal for the United States should be global harmonization
of hazard classification criteria, labels, and material safety data
sheets. No products or use categories should be exempted from
consideration.
2. While all products/use categories should be considered, it may not be
necessary for all authorities to adopt all classes agreed upon, or all
hazard warnings, within some parts of their systems. For example, a
consumer product labeling system may have broader definitions of
toxicity than a workplace labeling system in order to address concerns
involving exposure of children.
3. Uniform criteria for classifications should be accomplished first.
Use of the classifications for purposes other than labeling and
information transmittal should be taken into account. Hazard warnings,
symbols, and other information are based on the classifications, and
should be considered after agreement is reached on the classification
scheme. Hazard warnings should be tested to determine comprehensibility
before incorporation into a harmonized system.
4. Testing protocols and classification/labeling systems are closely
intertwined, and harmonization may have to include test methods and
interpretation of test results.
5. Discussions on criteria should be divided into 4 general groupings:
acute health hazards; physical/chemical properties; environmental
hazards; and chronic health hazards (e.g., carcinogenicity).
6. The guiding principle should be to adopt the most risk averse
approach from the existing systems, taking into account principle (2)
described above. A competent authority in any given jurisdiction cannot
be expected to adopt a less protective system than it currently has in
place. For example, with regard to acute oral toxicity, one of the
existing schemes uses a threshold of 25 mg/kg to define the highly
toxic category, and two others use 50 mg/kg. A threshold of 50 mg/kg
covers more chemicals under the highly toxic category than a threshold
of 25 mg/kg. Therefore, the most risk averse approach would be to use
50 mg/kg in a harmonized scheme.
7. Prior to negotiations on particular elements, participants will need
the following:
(a) An accurate description of existing systems used by various
countries.
(b) An understanding of the relative discretionary ability for a
competent authority or agency to modify its position; i.e., are the
requirements policy, regulation, or statutory legislation?
8. Procedures should be developed to ``grandfather'' test data generated
to comply with current classification schemes. Otherwise, there will be
extensive new testing to be done to reclassify substances and products
that may have been evaluated in the past for specific hazards, and
classified accordingly.
9. Plans need to be developed to ensure that all relevant groups are
kept apprised of progress or involved in relevant activities when
appropriate, i.e., chemical trade associations, public interest groups,
labor representatives, Congressional trade and health committees, etc.
10. Activities to work towards harmonization that are trade related must
seek to ensure that both general principles and specific
recommendations are GATT consistent.
It should be noted that while all chemicals are potentially covered
under the scope of this activity, there may be stages of a chemical's
life cycle that are not currently subject to hazard classification and
labeling requirements of the type being addressed in this harmonization
activity. Development of a globally harmonized system would not require
that such products be subject to these requirements in the future--that
decision will have to be made by individual countries. However, if
hazard classification and labeling of these products are added to a
country's regulatory provisions, the requirements will need to be
consistent with the globally harmonized system once it is developed and
adopted. As the international harmonization process proceeds, work will
have to be done domestically and internationally to clearly define and
delineate existing requirements to determine where there is interface
or overlap, and to identify exemptions as appropriate to accommodate
specific concerns regarding certain product types.
For example, the end use of products intended for human intake (by
any route, e.g., oral, dermal, or injection), would not be encompassed
in this harmonization effort because such products are not currently
subject to hazard classification and labeling requirements at that
point in the life cycle of the product. If one of these products is
defined as hazardous, however, there may be workplace, transport, and
environmental hazards associated with it in stages of the product's
life cycle before or after the intended use by consumers. Where there
are hazard classification, labeling or material safety data sheet
requirements to address these situations, these requirements would be
covered in the harmonization process. For example, nurses may be
required to mix antineoplastic (cancer treatment) drugs for
administration to a patient, and thus be potentially exposed to the
hazards of the material. In this case, OSHA requirements for material
safety data sheets and training to protect the nurse from workplace
exposure apply and are subject to the international harmonization
process.
International Activities
Background
An international mandate to pursue a globally harmonized system was
adopted at the United Nations Conference on Environment and Development
(UNCED) in 1992. Specifically, Chapter 19 of Agenda 21 states that: ``A
globally harmonized hazard classification and compatible
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labeling system, including material safety data sheets and easily
understandable symbols, should be available, if feasible, by the year
2000.'' Chapter 19 further recognized that while there is a globally
harmonized system available for the transport of chemicals, a globally
harmonized system which promotes the safe use of chemicals at the
workplace or in the home is not currently available. It recommended
that ``[t]he new system should draw on current systems to the greatest
extent possible; it should be developed in steps and should address the
subject of compatibility with labels of various applications.''
Work on a globally harmonized system is proceeding in a number of
international organizations. Following the adoption of the
international mandate as part of Chapter 19, governments established
the Intergovernmental Forum on Chemical Safety (IFCS), a forum of
government officials, which also has broad participation from
representatives of relevant non-governmental groups. Among the primary
charges of the IFCS is monitoring and providing broad guidance
regarding the implementation of the various activities called for in
Chapter 19, including harmonization. In this role, the IFCS at its
second session in February 1997 recommended that the harmonized system
envisioned in Chapter 19 Agenda 21 be implemented through a non-binding
legal instrument.
Another new group--the Inter-Organization Programme for the Sound
Management of Chemicals (IOMC)--was also established with
representatives from each of the six international organizations
involved in the process of accomplishing the work needed to meet the
commitments made in the UNCED agreements.
IFCS-IOMC Coordinating Group on the Harmonization of Chemical
Classification Systems
Under the auspices of IOMC, the Coordinating Group for the
Harmonization of Chemical Classification Systems (CG/HCCS) has been
managing the process of harmonization, and the International Labor
Organization (ILO) is the Secretariat.
The CG/HCCS comprises representatives of the countries or
organizations identified in the ILO report on the tasks involved in
harmonization as having the major existing systems (US, EU, Canada, and
UNCETDG), other interested countries and international organizations,
and stakeholder representatives (primarily industry, labor, and
environment). It meets twice a year to ensure that work is progressing,
to assign work, and generally to oversee the process. OSHA is the lead
U.S. agency involved in the work of the CG/HCCS, and the U.S. currently
chairs the group. The CG/HCCS is charged with elaborating the voluntary
instrument recommended by the IFCS.
The CG/HCCS has identified the following core elements as necessary
for a globally harmonized classification and hazard communication
system:
(i) Classification criteria for each hazard category and
corresponding labeling classes;
(ii) Internationally recognized testing procedures for each
criterion;
(iii) A procedure for establishing precedence of hazard for the
purpose of label selection;
(iv) A procedure for classifying preparations and mixtures;
(v) A procedure for the selection of precautionary phrases for
inclusion on labels;
(vi) Labeling symbols;
(vii) Appropriate risk and precautionary phrases;
(viii) Chemical safety data sheets;
(ix) A mechanism for protecting legitimate confidential business
information, without compromising health, safety, or the environment;
and,
(x) Appropriate information dissemination systems, provisions for
relevant training, and a mechanism to coordinate maintenance of the
harmonized system.
The CG/HCCS has also adopted a series of principles for the
harmonization process to guide the work of the various organizations
involved. These principles are included in the terms of reference for
the CG/HCCS. (See Table 2.)
Table 2.--International Principles for Harmonization of Chemical Safety
and Health Information
1. The level of protection offered to workers, consumers, the general
public and the environment should not be reduced as a result of
harmonizing the classification and labelling system.
2. The hazard classification process refers only to the hazards arising
from the intrinsic properties of the chemical elements and compounds,
and mixtures thereof, whether natural or synthetic.
3. Harmonization means establishing a common and coherent basis for
chemical hazard classification and communication, from which the
appropriate elements relevant to means of transport, consumer, worker
and environment protection can be selected.
4. The scope of harmonization includes both hazard classification
criteria and hazard communication tools, e.g. labelling and chemical
safety data sheets, taking into account especially the four existing
systems identified in the ILO report.
5. Changes in all these systems will be required to achieve a single
globally harmonized system, transitional measures should be included in
the process of moving to the new system.
6. The involvement of concerned international organizations of
employers, workers, consumers, and other relevant organizations in the
process of harmonization should be ensured.
7. The comprehension of chemical hazard information by the target
audience, e.g., workers, consumers and the general public, should be
addressed.
8. Validated data already generated for the classification of chemicals
under the existing systems should be accepted when reclassifying these
chemicals under the harmonized system.
9. A new harmonized classification system may require adaptation of
existing methods for testing of chemicals.
10. In relation to chemical hazard communication, the safety and health
of workers, consumers and the public in general, as well as the
protection of the environment, should be ensured while protecting
confidential business information, as prescribed by national
authorities.
The CG/HCCS is currently planning to make information available on
the internet in 1997 about the group's activities, papers developed,
and other information regarding the harmonization process.
The technical work of harmonization is being done by different
international organizations with specific expertise in the areas
involved. There are three areas of technical work currently underway:
criteria for health and environmental hazards; criteria for physical
hazards; and hazard communication components.
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Organization for Economic Cooperation and Development
Harmonization of the criteria for health and environmental hazards
is being done under the leadership of the Organization for Economic
Cooperation and Development (OECD). The criteria include acute health
hazards (such as irritation, sensitization, corrosivity, and acute
toxicity), chronic health hazards (such as target organ effects,
carcinogenicity, and reproductive toxicity), and environmental hazards
(such as aquatic toxicity). The CG/HCCS recently designated the OECD as
the focal point for the criteria for mixtures as well.
The OECD Chemicals Group has primary responsibility for this
activity, and has established an Advisory Group on Harmonization of
Classification and Labeling which is completing the work. The various
criteria or endpoints of concern have been assigned to working groups
composed of member countries. Background papers describing existing
requirements and position papers with recommendations for harmonization
are being developed for each criterion. The goal is to complete this
work in early 1998. Industry and labor are represented in all OECD
discussions through the Business and Industry Advisory Council (BIAC)
and the Trade Union Advisory Council (TUAC). EPA is the lead US agency
for the work on health and environmental hazard criteria in the OECD
and is coordinating national positions on harmonized criteria through
consultation with other affected agencies and the public.
United Nations Committee of Experts on the Transport of Dangerous Goods
Harmonization of the criteria for physical hazards is being done
under the leadership of the United Nations Committee of Experts on the
Transport of Dangerous Goods (UNCETDG) in conjunction with the
International Labor Organization (ILO). The UNCETDG has organized two
working groups to address the physical hazards which have been grouped
as either reactivity (such as explosive materials, oxidizing
substances, and self-reactive substances) or flammability hazards
(including solids, liquids, gases, and aerosols). By consensus, the
existing transport definitions for physical hazards are the basis for
the work, but adjustments are being made to accommodate concerns of
other user groups (e.g., workplace and consumers). The work on the
physical hazards is expected to be completed in 1997. DOT is the lead
US agency involved in the harmonization of physical hazard criteria and
is coordinating US positions through consultation with other U.S.
agencies and the public.
International Labor Organization
The third major component to be harmonized is the approach to
communicating the hazards determined through the harmonized
classification process. This would be the information that goes on a
label (e.g., warning statements, symbols) or material safety data sheet
(e.g., standardized headings). This work is being done through the
International Labor Organization (ILO), and is not expected to be
completed until the year 2000. Initial work to ascertain the current
approaches used by all countries with existing systems and the state of
the scientific literature regarding comprehensibility and effectiveness
of hazard communication approaches, is being done now to prepare for
receipt of the harmonized criteria and the development of an
appropriate approach to conveying information. A major concern is to
ensure that the requirements of the globally harmonized system address
issues related to the comprehensibility of the information conveyed.
OSHA is the lead U.S. agency in the international harmonization of the
hazard communication aspects. It is expected that a larger, more
formalized ILO work group will be established later this year. Since
the ILO is a tripartite organization, the work group will include
representatives of government, labor and industry.
Prospects for the Future
Much progress has been made in the past few years with regard to
the technical criteria for hazard classification. Work has also begun
on development of a nonbinding instrument in which the harmonized
system could be made available for adoption or ratification by
countries, and consideration of the appropriate maintenance mechanism
for the system when it is completed. Work has also begun on
consideration of the appropriate approach for classifying mixtures.
It is clear from the time frame for the work described thus far
that it will be several years before the system is completed and
available for countries to adopt. Determinations will also have to be
made about a mechanism for maintaining and updating the system to
ensure technical viability in future years.
Within the U.S., decisions will have to be made about how the
system will be applied in this country. In addition, legal alternatives
for adoption of the system will have to be developed and considered.
Given the differing legal frameworks in the U.S. for existing
requirements (i.e., statutory requirements versus regulatory
requirements), legislation may be needed to ensure that all agencies
can adopt the harmonized system. It is likely that a significant time
period will be required to phase in the new system and to train
affected users to understand its components.
Thus, while progress has been made, much work remains to be done
before the goal of a harmonized system is accomplished. The USG
believes that the benefits in terms of increased protection and
facilitation of trade are worth the effort required to participate in
the development of the system. It is clear that if the process is
successful, many countries will adopt the system, and, thus,
participation in international trade in chemicals will be largely
predicated upon implementation of the requirements. In order to shape
the design of the resulting globally harmonized system and ensure that
it meets the needs of the U.S., it is advantageous to actively engage
in discussions in these areas and participate in the organizations
charged with its development.
All of the major existing systems, as well as those that are not as
widely used, have strengths and weaknesses. The best approach to
harmonization appears to be development of a system that uses the
strengths and corrects the weaknesses identified through implementation
experiences within the existing systems. A system developed on this
basis will result in benefits to the U.S. through increased protections
for affected users while facilitating international trade.
As mentioned previously, an ancillary effect in the U.S. will be
harmonization of varying domestic requirements--thus benefiting
employers who are not involved in international trade but must comply
with varying U.S. requirements.
The agencies involved in the harmonization process can provide more
information about the specific international organizations they are
working with, and the status of the specific work involved. In
addition, as mentioned previously, there are organizations which are
representing industry, labor, and other stakeholders in the discussions
in the various international organizations, and they can be contacted
to provide specific input in areas of concern.
Request for Comments and Information
The U.S. government needs to better identify specific aspects of
the current
[[Page 15957]]
hazardous chemicals labeling regimes which may be posing technical
barriers to trade so as to better inform agency decisions with respect
to the global harmonization process. The U.S. government has identified
seven broad areas of concern:
(1) Chemical hazard information may or may not be received
routinely with imported chemicals and products (including mixtures) and
may or may not be understandable when received. Hazard information
which is received may not be consistent with what is required under
U.S. law, (e.g., sufficient to comply with OSHA's Hazard Communication
Standard). Without sufficient information, importers must independently
take steps to ensure that the chemical or product complies with U.S.
law.
(2) When shipping chemicals or products (including mixtures)
overseas, problems may have been encountered in determining what is
necessary to comply with the laws of other countries. Information about
these laws may be difficult to obtain and compliance with them may have
led to changes in U.S.-compliant labels or MSDSs. Such changes may
involve more than simply translating the U.S. label information into
the language of the country to which the material is being shipped.
(3) If national laws or international requirements in this area are
harmonized, each country or organization with existing systems will be
required to compromise and change its requirements to some extent. In
experiences dealing with the rules of different organizations, there
may be particular definitions, procedures, or components of existing
systems that would be desirable with regard to their inclusion in a
harmonized approach. Components of some already existing systems may
have been proven to be problematic in terms of either understanding or
implementation.
(4) The extent or amount of animal testing that must be conducted
in order to classify products may be affected by harmonization.
Criteria to assess existing test methodologies to ensure they are
equally acceptable in the harmonized approach may need to be developed.
(5) In order to implement a globally harmonized system, changes
might have to be made in existing U.S. laws or regulations. How much
time would be needed to phase-in any new requirements is not clear.
(6) Issues regarding protection of legitimate confidential business
information while maintaining the protection of those exposed to the
chemicals would have to be resolved.
(7) Information about experience in these different areas will
assist the U.S. government as work progresses on international
harmonization and could include samples of different labels and MSDSs
for the same substance or mixture when shipped to different countries.
This would be helpful to illustrate the kinds of problems encountered.
Information about the costs of complying with multiple requirements,
and potential cost savings from harmonization, would also help.
Information about applying the mixture rules of the existing systems to
products would assist in discussions addressing this part of the issue.
In addition to the input received from stakeholder representatives
actively involved in the process, the USG agencies are interested in
learning more about the experiences of other affected or interested
U.S. industry, labor, environment, or consumer groups dealing with
hazardous chemicals. Please submit any comments, experiences,
information or opinions with respect to the above seven areas of
concern or any other issues that may be of relevance.
Signed at Washington, DC, this 28th day of March 1997.
Rafe Pomerance,
Deputy Assistant Secretary of State for Environment and Development.
[FR Doc. 97-8505 Filed 4-2-97; 8:45 am]
BILLING CODE 4710-09-M