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HARMONIZATION OF HAZARD CLASSIFICATION AND LABELING QUESTIONS AND ANSWERS |
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1. What is the Globally Harmonized System (GHS) for classification and labeling of chemicals? The Globally Harmonized System (GHS) for the classification and labeling of hazardous chemicals is the goal of an effort by the U.S. and other countries to promote common, consistent criteria for classifying chemicals according to their health, physical and environmental hazards, and to develop compatible labeling, material safety data sheets for workers, and other information based on the resulting classifications. Currently, a number of countries operate their own systems for classification and labeling, and companies must comply with differing requirements depending on where they do business. A harmonized system would lead to greater consistency among countries and thereby promote safer transportation, handling and use of chemicals. Harmonized criteria, symbols and warnings will promote improved understanding of hazards and thus help to protect workers and other potentially exposed populations. A more uniform, "harmonized" system should also reduce costs for companies involved in international trade. 2. Who is involved in the harmonization effort? The United States government is participating in GHS activities with a number of other countries and key industry, worker, and public interest stakeholders. At the international level, the 1992 United Nations Conference on Environment and Development (UNCED) and the Intergovernmental Forum on Chemical Safety have endorsed the GHS. The Organization for Economic Cooperation and Development (OECD), which includes most industrialized nations as members, is coordinating the development of health and environmental hazard classification criteria. The United Nations' Committee of Experts on the Transport of Dangerous Goods (UNCETDG) is coordinating the development of criteria for physical hazards. The International Labour Organisation (ILO) serves as the Secretariat for overall harmonization effort and hosts the hazard communication working group. Each of these international organizations involves affected industries and other non-governmental organizations in their deliberations. Within the United States, key federal agencies with responsibility for regulatory and international affairs have formed an interagency committee coordinated by the Department of State. Participating agencies include the Consumer Product Safety Commission (CPSC), Department of Commerce, Department of Transportation (DOT), Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Office of the U.S. Trade Representative, Department of Agriculture, and National Institute of Environmental Health Sciences. The interagency committee and individual agencies have also solicited the participation of key private sector groups, companies and trade associations, worker representatives, health and safety professionals, and environmental and public interest groups. 3. What are the advantages of harmonization for the U.S.? Harmonization will promote regulatory efficiency and facilitate trade without lowering the level of health and environmental protection afforded by current U.S. laws and regulations. Greater consistency in chemical hazard classification and labeling requirements worldwide will make it easier for companies to comply with applicable standards and reduce the costs associated with the need to follow different rules in different countries. Common classification criteria, labeling, and other information materials will help companies and countries provide better, more consistent information about chemical hazards, thereby promoting safer transport, handling, and use. Other potential benefits of the harmonized system could include reduction in the need for animal testing to comply with divergent national systems and conservation of scientific resources as a result of the adoption of a coordinated approach to updating the system to reflect scientific advances. U.S. participation in the GHS will be voluntary, and we will be able to adapt the system as appropriate to our circumstances. Where we now have classification, labeling and related requirements imposed by various domestic regulatory agencies, harmonizing in the global context may also improve domestic coordination. The GHS will in no way supersede the health and safety standards contained in U.S. laws and regulations, or make decisions that are properly within the purview of U.S. agencies. Rather, it will serve as a nonbinding mechanism to promote consistency. 4. What types of products and information would be affected? The scope of the harmonization effort includes all chemicals, which is consistent with the U.S. regulatory scheme. While the GHS will classify chemicals essentially based on their intrinsic properties, without full analysis of exposure and risk, the system may apply differently in different settings or stages in the "life cycle" of a product. For example, although criteria will cover both acute and chronic health hazards, in general it will not be necessary to apply chronic health hazard criteria and labeling in the transportation sector, where exposures are brief and concerns focus primarily on emergency situations. There are also situations in which regulatory agencies examine risk and determine that use or consumption of the product pose no significant risk. Examples include the presence of small quantities of pesticide and other residues in food. While these chemicals may be hazardous in larger quantities when handled by workers and would be subject to hazard classification and labeling requirements in the workplace and in transport, the appropriate regulatory authorities have determined that they pose no significant risk at the levels found in food. Therefore, they are not subject to hazard labeling at that point in the product life cycle. Similarly, the end use of other products intended for human intake or application, such as investigational pharmaceuticals and those approved for use by the Food and Drug Administration and cosmetics as used by consumers, would not be covered. Pharmaceutical and cosmetic chemicals are subject to OSHA and DOT requirements in the workplace and transport settings, however, and the GHS would apply in those circumstances. Because the focus of GHS is on hazard classification and communication, the GHS will not focus on "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 likely exposures and risks. The GHS will be implemented through a non-binding instrument. Countries will be free to apply the hazard classification system in the manner they consider appropriate to their own conditions and regulatory framework, just as they apply currently available hazard classification systems through their own domestic procedures. The GHS will not require the development of any new regulatory schemes or impose any new requirements on existing risk-based regulatory systems. Rather, the aim is to promote consistency among existing national schemes. U.S. agencies are continuing to participate in the development of the GHS and evaluating how the system could be applied in the U.S. context. 5. Will the GHS affect consumer product labeling, such as for household chemicals and cosmetics? Questions have been raised in the U.S. and other countries about whether it will be possible to harmonize different approaches for consumer exposure to finished products. Some have expressed concern that including these products adds an element of complexity that cannot be resolved easily, particularly when considering the risk related to likely consumer exposures. Therefore, some groups have advocated that application of the harmonized system should, at least initially, be limited to labels and information for transport and workplace exposures, and should not address labeling at the global level for final consumer use. The international GHS Coordinating Group indicated in the past that integration of certain products may have to be postponed if inclusion would result in unacceptable delays in reaching consensus. At its June 1998 meeting, the GHS Coordinating Group reached consensus on a paper clarifying the scope of the GHS. The paper notes that, while the scope of the GHS includes all chemicals and chemical mixtures, application of the system may vary by type of product or stage of the life cycle and that, once a chemical is classified, the likelihood of adverse effects may be considered in deciding what steps should be taken for a given product or use setting. In addition, the Group agreed that there will be a need for further discussions to address application issues for some product use categories which may require specialized expertise. Also in 1998, the working group developing classification criteria for mixtures concluded that the GHS will not cover cosmetic products in the consumer use setting, since none of the existing systems apply hazard classification and labeling in those circumstances. The hazard communications phase of the GHS will also consider unresolved sectoral issues. Of course, there will be no changes in U.S. labeling requirements without full consideration under U.S. statutory authorities and standard regulatory procedures. 6. When will the system be in place? The initial goal set by UNCED called for the development of "a globally harmonized hazard classification and compatible labeling system, including material safety data sheets and easily understandable symbols, [which] should be available, if feasible, by the year 2000." While much progress has been made, participants now anticipate that work on the hazard communications elements of the GHS will continue into 2001. Harmonized classification criteria for chemical substances and mixtures will be combined with the communications materials to form the GHS, along with appropriate guidance to countries to help them apply the system. Once the basic GHS is complete and available to countries for implementation, it is expected there will be a phase-in period for adoption and application. To the extent U.S. regulatory agencies determine that changes in U.S. laws, regulations, or policies are appropriate as a result of application of the GHS, they will propose necessary changes and initiate normal regulatory procedures consistent with the Administrative Procedure Act and other applicable statutes. 7. What is the process for developing the harmonized classification and labeling system? Internationally, the Intergovernmental Forum on Chemical Safety provides overall oversight of the implementation of UNCED Chapter 19 activities, which include the GHS. A Coordinating Group on the Harmonization of Chemical Classification Systems, chaired by the U.S., is charged with managing the process of GHS development. Work is proceeding in three major areas:
8. Would the GHS impose new or different testing requirements on chemical manufacturers? Would manufacturers have to use specific test methods or protocols? No. The GHS itself does not require any testing. The GHS gives guidance on how test results may be used to classify chemical hazards. (Of course, testing may be required by national authorities as part of their regulatory process, or carried out at the producer's own initiative.) There is general agreement that the system will not favor one set of scientifically sound test methods over another for the assessment of health or environmental hazards. This is important, since different test methodologies may be appropriate for different types of chemicals or different uses of a chemical. It is also important that the system not retard the development of new, improved test methods for assessing potential effects on health and the environment. For example, work is proceeding to develop in vitro tests for effects that now require animal testing. Should these methods prove valid and acceptable, they may replace or supplement animal tests now required by regulatory agencies. In general, the classification proposals developed by the Organization for Economic Cooperation and Development (OECD) specify that test methods should be scientifically valid, and the best available information should be used in classification. At the outset, U.S. agencies and the Coordinating Group for the Harmonization of Chemical Classification Systems (CG/HCCS) thought that it might be necessary to include test methods in the harmonization process. This was reflected in some of the original guiding principles issued in 1992 and in the terms of reference of the CG/HCCS, as described in an April 3, 1997 Federal Register notice. In the case of physical hazards (such as explosivity, flammability, etc.), testing methods are generally well-defined and agreed-upon. For example, "flash points" for flammability can be objectively determined and defined in terms of temperature and will be included in the classification criteria. For health and environmental effects, however, consensus has evolved over time, and current thinking at the national and international level is that the system should not prescribe specific methodologies. Therefore the OECD classification proposals do not prescribe test methods, but may cite examples. This will allow the best available data to be used, and encourage the development of better methods. 9. What will happen if scientists and/or regulatory authorities in different countries reach different conclusions about how to interpret test data and their relevance to human health or environmental effects? Experience with the current global system for classification and labeling of hazardous goods in transport indicates that, in some cases, countries may reach different conclusions and labels may as a result not be fully harmonized. It is likely that some inconsistencies will remain under the GHS. In general, however, greater consensus is likely to develop over time, and the GHS will promote greater uniformity in classification and labeling than now exists. 10. Would U.S. laws or regulatory policies have to be changed to implement the new system? If so, which ones? As with any effort to harmonize multiple systems, the GHS is likely to result in some changes in each existing system of hazard classification and labeling. At the international level, we are working to harmonize differences in classification criteria, without lowering the overall level of protection afforded by existing systems. We would also expect the hazard communications working group to develop standard label phrases and symbols that could be implemented internationally. U.S. regulatory agencies with programs that could potentially be affected by the GHS will decide upon implementation in the U.S. In general, the interagency group's analysis of the parameters for application of the GHS within the United States, as reflected in U.S. government comments to the GHS Coordinating Group, indicates that the GHS can be implemented consistent with our current regulatory framework for different types of chemical products in different use settings. If U.S. agencies determine that changes in U.S. laws, regulations, or policies are necessary as a result of application of the GHS, they will propose necessary changes and initiate normal regulatory procedures consistent with the Administrative Procedure Act and other applicable statutes. 11. What if the US does not adopt the GHS? The U.S. has long supported a globally harmonized system for hazard classification and labeling and has taken an active role in the development of a system that will be compatible with our domestic regulatory framework. We believe that strong U.S. participation in the international effort is in the best interest of the United States. While the U.S. is free to decline to adopt the GHS, the international effort will proceed. We expect other countries will adopt the resulting system. Although the system is not legally binding on countries, countries that do choose to implement it are likely to impose binding requirements for chemical classification and labeling consistent with the GHS . To the extent that U.S. companies seek to do business in other countries, they will need to comply. Thus, if the U.S. did not participate in the GHS, the benefits of harmonization would not be realized, and companies would continue to bear the costs of complying with multiple, inconsistent national requirements. 12. How will the system be maintained in the future to accommodate new scientific developments? Participating countries have not yet reached final decisions on all aspects of how the system will be updated and maintained. The Coordinating Group proposed and the UNCETDG agreed to recommend the creation of a subcommittee of experts under the auspices of the UN Economic and Social Council (ECOSOC), parallel to the existing Subcommittee of Experts on the Transport of Dangerous Goods (UNSCETDG) and reporting through a joint committee to the ECOSOC. The Secretariat for GHS maintenance would be placed within the United Nations office that now covers international transport matters. The ECOSOC approved this basic approach in late 1999. Work is proceeding to determine the appropriate composition of the proposed joint committee and GHS subcommittee, and to develop consensus on more detailed terms of reference that will meet GHS needs while avoiding disruption in ongoing transport functions. |
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