[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: <a href="/cdn-cgi/l/email-protection#c8acbaa9aaa9aca9a688bbbca9bcade6afa7be"><span class="__cf_email__" data-cfemail="3f5b4d5e5d5e5b5e517f4c4b5e4b5a11585049">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#442e372d282f042b372c25693728276a232b32"><span class="__cf_email__" data-cfemail="2d475e4441466d425e454c005e414e034a425b">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#3b4952484b5255155a56427b5e4b5a565a5257155e4b5a155c544d"><span class="__cf_email__" data-cfemail="47352e34372e2969262a3e072237262a262e2b6922372669202831">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#afc9ddc6dbdc81d8d6cdcac1c8ceefdddcdfce81cbc0db81c8c0d9"><span class="__cf_email__" data-cfemail="2f495d465b5c0158564d4a41484e6f5d5c5f4e014b405b01484059">[email protected]</span></a>.

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

[[Page 15954]]

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

[[Page 15955]]

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.

[[Page 15956]]

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


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