U.S. NATIONAL PROFILE ON THE MANAGEMENT OF CHEMICALS

EXECUTIVE SUMMARY

INTRODUCTION

The Intergovernmental Forum on Chemical Safety (IFCS) has identified the need for national profiles on management of chemicals to indicate current capabilities and capacities for management of chemicals and identify program needs. This National Profile on Management of Chemicals in the United States may be the first time that information on all of the Federal chemical safety programs, as well as information about representative state and non-governmental activities, has been brought together in one document. It is hoped that it will serve as a useful reference document both domestically and internationally to inform both specialists and the general public and help guide U.S. chemical safety activities and coordination efforts.

1. NATIONAL BACKGROUND INFORMATION

Chemical safety management in the U.S. must be considered in the overall context of physical, political, demographic, industrial and agricultural characteristics of the country. The U.S. is the world's fourth­largest country (after Russia, Canada, and China). The climate is mostly temperate but has wide extremes in some areas. It has a diverse terrain, rich natural resources and 20% arable land. The population of the United States is 264 million (1995 est.). There is a high literacy rate -- 97% of the population age 15 and over has completed five or more years of schooling. The U.S. is a constitutional democracy with authority distributed between the central Federal government and the 50 states. The US has the most powerful, diverse, and technologically advanced economy in the world, with a per capita Gross Domestic Product (GDP) of $25,850, the largest among major industrial nations. The economy is market oriented with most decisions made by private individuals and business firms and with government purchases of goods and services made predominantly in the marketplace. Agriculture accounts for 2% of GDP and 2.9% of labor force; favorable climate and soils support a wide variety of crops and livestock production; world's second largest producer and number one exporter of grain.

2. CHEMICAL PRODUCTION, IMPORT, EXPORT AND USE

The United States has a complex chemical industry structure. The chemical industry represents about 10.3 per cent of value added in the manufacturing sector and accounts for 5.1 percent of GDP in the United States. Some 7, 335 companies employ about 1.1 million people, or 6 per cent of the manufacturing industry labour force. Most of the companies are quite small; some 200 account for more than 83 per cent of total sales, which reached $337 billion in 1994. The largest concentrations of chemical plants are in Texas, Louisiana and New Jersey. The chemical industry is strong and growing. Investment in new plant and equipment reached $21.8 billion in 1993 and R&D spending totalled $16.7 billion. The US chemical industry is the world's largest, and the second largest chemical exporter. In 1994, its exports were worth over $51 billion and accounted for some 15 per cent of its output; US imports of chemicals amounted to over $33 billion. Chemicals are used by the general publc in many facets of daily life at home and in the workplace.

3. PRIORITY CONCERNS RELATED TO CHEMICAL PRODUCTION, IMPORT, EXPORT AND USE

The United States has strong chemical safety authorities and programs implemented by many public and private organizations. Priorities and needs vary across agencies and regions of the country. EPA's pesticides and industrial chemicals program offices are developing draft chemical safety goals as part of EPA's comprehensive Environmental Goals Project and these are briefly described in Section 3.1. General chemical safety program needs are described in section 3.2. EPA's priority concerns for pesticides and industrial chemicals are described in section 3.3. Other agencies have also established priorities. For example, the Public Health Service has its "Healthy People 2000 goals." A comprehensive listing of the priority concerns of all U.S. agencies involved in chemical safety is beyond the scope of this profile.

OECD recently reviewed the United States' environmental performance and made a number of recommendations that are under review within the U.S (ref. Section 3.4). Finally, EPA is participating in the government-wide effort to implement the Government Performance and Results Act (GPRA) (ref. Section 3.5).

The principal goals being established for EPA in concert with other agencies as part of EPA's Environmental Goals Project are expected to include the following broad themes, each of which will have associated indicators and milestones: (1) the foods Americans consume will continue to be safe for all people to eat; (2) all Americans will live, learn, and work in safe and healthy environments; (3) by relying on pollution prevention, reuse and recycling in the way we produce and consume materials, all Americans will live in communities free of toxic impacts; and (4) Americans will be informed and educated participants in improving environmental quality; they will exercise their right to know about pollutants in their communities, make informed environmental decisions, and participate in setting local and national priorities.

As described in Section 3.3.1, EPA's Office of Pesticide Programs (OPP) has identified a number of areas where improvements are needed in pesticide regulatory programs and significant changes are expected by 2001. These improvements will cumulatively have a major effect in increasing program efficiencies and risk reduction to the public and the environment. They include: (1) the need for a more stable funding base; (2) completion of the first round of reevaluation of older pesticides; (3) implementation of the major pesticide statutory changes enacted in 1996; (4) broader input from stakeholders; (4) a fully trained agricultural worker population, achieving significant risk reduction for this most exposed population; (5) electronic submission and processing of data and electronic access to non-confidential review information by the public; (6) meaningful work sharing on pesticide reviews with other countries; (7) achievement of risk reduction through expedited approval and encouragement of biopesticides and other generally safer chemicals through an expanded Pesticide Environmental Stewardship Program (PESP), which established partnerships with grower organizations and others to reach measurable, voluntary risk reduction goals; (8) responding to public concerns to have non-carcinogenic pesticides and focus on exposures other than food; (9) availability of a 24-hour toll-free hotline to respond to citizen concerns; (10) an updated National Food Consumption Survey and a more comprehensive Residue Data Base; and (11) free access to information by all interested parties.

As described in Section 3.3.2, EPA's Office of Pollution Prevention and Toxics has identified the following principles to guide its current and future industrial chemicals program initiatives:

First, preventing pollution offers the first and often the best opportunity for protecting health and the environment.

Second, empowering the public with information helps assure compliance with existing laws and encourages companies to take additional measures to reduce industrial chemical releases.

Third, industry and EPA can work cooperatively and in partnership to improve our environment. When empowered with information on pollution prevention and other important tools, industry has taken the initiative to reduce the impact their products and processes have on the environment.

These lessons are the cornerstone of EPA's new approach for addressing industrial chemicals in the environment. EPA plans to continue to incorporate these three lessons into its programs in an intelligent and responsible manner. The agency recognizes that there are times when it may need to move beyond the first choice on the waste management hierarchy, pollution prevention, that public empowerment carries with it the need to provide the information and education that the public requires to make sound decisions; and that there will always be the need for Federal oversight in environmental issues. However, when applied thoughtfully, these principles will result in a better environment. The principles of pollution prevention, right-to-know, and stakeholder partnerships form the foundation of the nation's industrial chemical program now and in the future. As it has over the past twenty years, EPA's understanding and application of TSCA will continue to grow and evolve as it faces the challenges of reducing industrial chemical risks over the coming decades.

4. LEGAL INSTRUMENTS AND NON-REGULATORY MECHANISMS FOR MANAGING CHEMICALS

(a) Principal Statutes. The United States has a complex set of chemical safety statutes and regulations administered by a number of Federal agencies. The principal statutes are briefly described below.

Toxic Substances and Control Act (TSCA) regulates industrial chemicals, including heavy metals. Identifies and controls industrial chemical hazards that are toxic to human health and the environment. Administered by the Environmental Protection Agency (EPA).

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires EPA registration for all pesticides sold in U.S. It is a violation of FIFRA to use a pesticide in a manner inconsistent with its label, including the specified uses. FIFRA was revised and strengthened substantially in August 1996.

Federal Food, Drug and Cosmetic Act (FFDCA) regulates the establishment of pesticide tolerances (maximum residue levels). FFDCA was revised and strengthened substantially in August 1996. (EPA and the Food and Drug Administration (FDA))

Emergency Planning and Community Right-to-Know Act (EPCRA) requires local emergency planning for responses to industrial chemical or pesticide accidents; requires industry to notify their communities and states of releases; provides information from companies about possible industrial chemical or pesticide hazards in the facility's community; mandates a national inventory of toxic chemical releases (Toxics Release Inventory (TRI)). (EPA)

Clean Air Act (CAA) establishes criteria and standards for regulating toxic air pollutants in order to safeguard public health and the environment. (EPA)

Clean Water Act (CWA) establishes criteria and standards for pollutants, including some pesticides, in surface water bodies to protect against chronic ecosystem effects. (EPA)

Safe Drinking Water Act (SDWA) establishes enforceable Maximum Contaminant Levels (MCLs) for pesticides and Health Advisories. There were major revisions to strengthen SDWA enacted in August 1996. (EPA)

Resource Conservation and Recovery Act (RCRA) requires appropriate handling and disposal of hazardous waste. (EPA)

Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) covers incidents with hazardous materials and mandates the EPA Superfund program to clean up the highest priority sites contaminated by chemicals. The Agency for Toxic Substances and Disease Registry (ATSDR) evaluates data on release of hazardous substances to assess impact on public health, initiate toxicologic research, establishes and maintains registries for persons exposed to hazardous substances, and provides response to emergency release of substances. (EPA and ATSDR).

Hazardous Materials Transportation Act (HMTA) ensures the safe and environmentally sound transportation of hazardous materials by all modes of transportation through a comprehensive, risk-based, national program. (Department of Transportation (DOT))

Federal Hazardous Substances Act (FHSA), Consumer Product Safety Act (CPSA) and Poison Prevention Packaging Act (PPPA) regulate the safety of consumer products, including chemical safety. (Consumer Product Safety Commission (CPSC))

Occupational Safety and Health Act (OSHA) regulates toxic chemicals related to occupational safety. (Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH).

(b) More Information About Principal EPA Regulatory Authorities. EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) has the lead U.S. responsibility for implementing TSCA, EPCRA, FIFRA and FFDCA (ref. 4(a) above) through its two program offices: the Office of Pollution Prevention and Toxics (OPPT) and the Office of Pesticide Programs (OPP).

EPA/OPPT oversees implementation of the Toxic Substances Control Act (TSCA). TSCA was enacted in 1976 to identify and control industrial chemical hazards that are toxic to human health and the environment. Episodes of environmental contamination, including the pollution of a major waterway with polychlorinated biphenyls (PCBs), the threat of stratospheric ozone depletion from chlorofluorocarbon (CFC) emissions, and contamination of a State's agricultural produce by polybrominated biphenyls, showed the need for stronger and more comprehensive industrial chemical legislation. Subsequently, in the 1980s and 1990s, TSCA was strengthened to control three chemicals -- asbestos, radon, and lead -- that are very harmful and have widespread exposure. EPA has broad authority, under TSCA, to regulate new and existing chemicals.

TSCA directs EPA to use the least burdensome option that can reduce the risk to a level that is reasonable given the benefits provided by the chemical product or process. Civil and/or criminal penalties are imposed on any person who violates a requirement made under the Act. While EPA implements most of the provisions under TSCA, the States have authority to fulfill some of the Act's mandates. In particular, TSCA gives the States authority when their knowledge of local conditions is needed to control certain chemicals.

EPA/OPP has primary responsibility for implementing the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and pesticide regulatory authorities in the Federal Food, Drug and Cosmetic Act (FFDCA). The U.S. first started regulating pesticides in 1910. FIFRA was passed in 1947 to govern the registration (licensing) of pesticides. FFDCA was amended in 1954 to add the regulation of pesticide residues. Pesticide residues in food, farmworker exposure, and pesticide contamination of ground water have all contributed to a growing concern over the widespread use of pesticides. In 1988, FIFRA was amended substantially to accelerate the review and reregistration of older pesticides. Both FIFRA and FFDCA were substantially revised and strengthened in 1996 by the Food Quality Protection Act, which gives EPA important new tools: a uniform health­based standard based on "a reasonable certainty of no harm," better protection for children, and an improved science base for EPA decisions.

FIFRA and FFDCA address risk reduction through licensing restrictions on individual pesticide products and the establishment of tolerances (maximum residue levels) for chemical/use combinations. No pesticide may be legally sold in the U.S. unless it bears an EPA registration number. FIFRA Section 3(c)(2) contains important provisions that provide EPA with the authority to establish data requirements for registration of pesticide products and to call in additional data after registration if EPA determines this is necessary to ensure the product is not likely to cause unreasonable adverse effects. It is a violation of the law for any person to use a pesticide in a manner inconsistent with its label, including the specified uses. FIFRA imposes civil as well as criminal penalties for violations. The Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) enforce tolerance (maximum residue) levels on both domestic and imported foods. The States generally assume responsibility for enforcement of pesticide distribution and use requirements, aided by Federal grants.

In 1992, EPA issued strengthened worker protection standards. The new standards covers 3.9 million workers employed on farms, forests, nurseries, and greenhouses. The new standards are expected to reduce very significantly the number of reported and unreported acute pesticide poisoning incidents each year.

Some states have pesticide regulatory and enforcement programs that exceed Federal requirements in some areas. For example, the State of California's Department of Pesticide Regulation (Cal/DPR) has state-level requirements to conduct independent assessments and registration of pesticide products. EPA and DPR are working closely together to harmonize assessment procedures and share the assessment workload.

OPPT implements part of the Emergency Planning and Community Right-to-Know Act (EPCRA). EPCRA was passed in 1986 to prevent major chemical accidents from occurring due to industrial activities and to limit their consequences for man and the environment. Chemical release incidents-such as in Institute, West Virginia; Bhopal, India; and Chernobyl-heightened government awareness of the critical need for effective emergency planning. These accidents also made Americans more concerned than ever before about the need for information on the presence of hazardous chemicals in their communities and releases of these chemicals into the environment.

Under EPCRA, EPA has authority to promulgate regulations for the emergency preparedness and the community access to chemical information provisions. EPCRA has four main purposes:

• To require local emergency planning for responses to industrial chemical or pesticide accidents.

• To require industry to notify their community and the State of the routine or accidental release of an industrial chemical or pesticide.

• To provide the public and the State with information from companies about possible industrial chemical or pesticide hazards in the facility's community.

• To develop a national inventory of toxic chemical releases that will give the public and government information about chemicals to which they may be exposed (Section 313 of EPCRA). Manufacturers, importers, processors, and users are required to report approximately 600 industrial chemicals, pesticides, and categories of these chemicals. EPA and the States receive data on the amounts of the chemicals that the companies release directly to air, water, or land, or that they transfer to off-site facilities that treat or dispose of wastes.

EPA implements the Toxics Release Inventory (TRI) provisions under EPCRA. Certain facilities are required to annually report their releases and waste management information for listed chemicals. EPA then makes this information publicly available through TRI, which is a database that is accessible electronically. In 1996, EPA published a proposed rule to add seven industry sectors to the current list of facilities required to submit data. This effort, known as TRI Industry Expansion, will greatly strengthen community right-to-know by providing information on toxic chemical releases and waste management from companies that are not the manufacturing facilities that are currently reporting.

In the past, EPA relied heavily on its regulatory authorities to achieve its goals. EPA now recognizes that more cooperative methods are often more efficient and effective. Regulation is still a viable tool and is used when necessary. However, the risk management activities are increasingly turning to cooperative and voluntary methods as first approaches to reducing or eliminating the likelihood of harm to human health and the environment.

(c) Non-Regulatory Approaches. EPA uses many non-regulatory methods to manage chemical risks. These approaches include voluntary actions -- such as negotiated agreements for testing, hazard communication, product stewardship, safer work practices, or termination of the sale or use of a chemical or product. Voluntary methods or a combination of voluntary actions and regulation are sometimes the best solution. Voluntary methods are comparable in effectiveness to regulation and often can be accomplished more quickly. Government partnerships involve cooperation among regional, Federal, State, and local governments. EPA often provides technical and analytical work to support the actions of its partners. EPA emphasizes pollution prevention and promotion of safer substitutes, including removing chemicals of concern from the marketplace or reducing the emissions of certain chemicals. EPA uses chemical emission data from TRI to target chemicals and facilities of concern.

The 33/50 program is a good example of a successful, voluntary pollution prevention program. The 33/50 program targets seventeen high priority toxic chemicals for reduction through voluntary partnerships with industry. The program's name stems from its goals: a 33% reduction by 1992 and a 50% reduction by 1995. EPA is proud to report that almost 1,300 companies agreed to reduce voluntarily their releases and transfers of the targeted 33/50 chemicals. Their efforts helped 33/50 reach the 50% goal a year ahead of schedule.

Information dissemination has been found to be a valuable tool for obtaining results. Advisories warning the public of hazards from chemicals have encouraged people to voluntarily reduce the risks. The involvement of stakeholders early in the risk management process helps to ensure that their needs are met. Product stewardship is a principle many industries have committed to follow.

Past approaches to pesticide regulation focused on careful analysis and evaluation of discrete pesticides. Although this remains important, it is insufficient to deal with new issues, such as multiple residues, differential sensitivities of infants and adults, and the need to manage pests. The U.S. is beginning to look at risk concerns more comprehensively, finding faster and more effective ways to reduce real risks and share resources and expertise. The most effective, least costly solution is prevention of problems rather than trying to fix them retroactively.

While EPA and FDA retain a primary focus on regulatory action, they also, in concert with USDA, are working to create non-regulatory programs which encourage voluntary efforts to prevent or mitigate the human health and environmental impacts of pesticide use. The U.S. has begun a special initiative to reduce pesticide risks, both through legislative/regulatory initiatives and voluntary efforts. The initiative focuses particularly on risk/use reduction strategies and increased use of Integrated Pest Management (IPM). As part of this initiative, EPA has implemented the Pesticide Environmental Stewardship Program (PESP) in which committed grower groups and utilities develop and implement plans to reduce pesticide risks and use. PESP is proving to be a very successful public/private partnership that achieves significant risk reduction through voluntary efforts by EPA's PESP partners. USDA is focusing on expanded use of IPM. Growers in many parts of the U.S. are changing their pest control practices to make significant reductions in use of synthetic chemical pesticides.

5. U.S. FEDERAL AGENCIES RESPONSIBLE FOR CHEMICAL SAFETY MANAGEMENT

Four U.S. Federal agencies have promulgated most of the regulations controlling chemicals and, hence, have the most information on the chemicals they manage. Each agency regulates chemicals at a different stage of their life cycle. The Occupational Safety and Health Administration (OSHA) identifies and controls the hazards to workers in most industries from exposure to chemicals. The Consumer Product Safety Commission (CPSC) and the Food and Drug Administration determine and manage the risks from chemicals in consumer products and foods, human and animal drugs, and cosmetics, respectively. These organizations have information on the potential hazards of chemicals in these products. The Environmental Protection Agency (EPA) regulates chemicals that can not be controlled using the authorities of the above three agencies. Hence, EPA is an excellent source of information on the potential adverse effects of certain chemicals at any stage of their life cycle, from manufacture to disposal. The agencies often work together to manage chemicals. For example, EPA received input from OSHA and CPSC in banning and phasing out asbestos.

Other agencies provide scientific support to the four principal regulatory agencies. The following descriptions provide brief overviews of the responsibilities and programs of the U.S. agencies responsible for some aspect of chemical safety management.

Environmental Protection Agency (EPA). EPA is charged by Congress to protect the Nation's land, air, and water systems. Under a mandate of national environmental laws, the Agency strives to formulate and implement actions that lead to a compatible balance between human activities and the ability of natural systems to support and nurture life. The Agency's priorities include emphasizing flexibility and innovation, working in partnerships with private and government groups, and encouraging sound science and engineering. For example, under the "Common Sense Initiative" the Agency looks at pollution industry­by­industry, rather than by using the pollutant­by­pollutant approach of the past. Everyone concerned with a given industry­­from manufacturers to community organizations­­works together to fashion new strategies to emphasize preventing pollution.

EPA works in partnership with state, county, municipal, and tribal governments to carry out its mission. State and local standards may exceed federal standards, but they cannot be less stringent. EPA works with states and municipalities so they can carry out federal standards consistently but flexibly. The Agency also makes extensive efforts to involve the public in environmental protection. Some laws specifically invite public monitoring; others allow individuals to sue polluters or to notify environmental agencies of violations.

Through research, development, and technical assistance, EPA generates and disseminates sound science and engineering to support its missions. These efforts provide the data that the Agency needs to set and address priorities in identifying, assessing, and managing serious risks to public health and the environment. EPA's research combines the in­house expertise of its scientists and engineers with complementary research by universities and nonprofit organizations under a competitive, peer­review extramural program.

State Department. The State Department coordinates the participation of U.S. government agencies in international chemical safety fora, including the development of U.S. policies on international issues. It also funds a number of international programs and helps coordinate Federal agency funding of international chemical safety activities.

Food and Drug Administration. FDA is an agency within the Public Health Service of the Department of Health and Human Services. It is FDA's job to ensure the safety and wholesomeness of U.S. food and the safety of cosmetics, medicines and medical devices, and radiation­emitting products. Animal feed and drugs for pets and farm animals also come under FDA scrutiny. FDA also ensures that all of these products are labeled truthfully with the information that people need to use them properly. A major FDA mission is to protect the safety and wholesomeness of food. The agency's scientists test samples to see if any substances, such as pesticide residues, are present in unacceptable amounts. If contaminants are identified, FDA takes corrective action. FDA also sets labeling standards to help consumers know what is in the foods they buy. The nation's food supply is protected in yet another way as FDA sees that medicated feeds and other drugs given to animals raised for food are not threatening to the consumer's health.

FDA regulates prescription and over­the­counter medicines for humans through its Center for Drug Evaluation and Research. Cosmetic safety also comes under FDA's jurisdiction. The agency can have unsafe cosmetics removed from the market. The dyes and other additives used in drugs, foods and cosmetics also are subject to FDA scrutiny. The agency must review and approve these chemicals before they can be used. FDA's scrutiny does not end when a drug or device is approved for marketing; the agency collects and analyzes tens of thousands of reports each year on drugs and devices after they have been put on the market to monitor for any unexpected adverse reactions.

U.S. Department of Agriculture (USDA) in cooperation with EPA, assesses the benefits of pesticides, and works with farmers and other pesticide users on the proper use of and alternatives to pesticides. USDA enforces tolerance (maximum residue) levels for meat, milk and eggs on both domestic and imported foods. USDA and EPA work together closely to implement coordinated research, technology development, and technology transfer systems that support agricultural practices that protect and enhance the environment. As part of an initiative to reduce pesticide risks and use, EPA and USDA will promote sustainable agriculture and Integrated Pest Management (IPM) practices, including biological and cultural control systems, setting a goal of implementing IPM programs on 75% of the total crop acreage in the U.S. by the year 2000. USDA supports research and education programs with the cooperation of State Agricultural Experiment Stations and State Cooperative Extension Service staff.

Consumer Product Safety Commission (CPSC) authorities and regulations for consumer product safety provide for labeling or banning hazardous household chemicals and products, regulation of various consumer products, including extremely flammable contact adhesives and lead-containing paint and related products, and requirements for special packaging of hazardous products, including oral prescription medicine. CPSC can declare a substance to be a banned hazardous substance pending completion of rulemaking procedures for imminent hazards. CPSC can bring a court action to seize any misbranded or banned hazardous substance. CPSC can also bring a court action based on imminent hazard under the Consumer Product Safety Act, and can apply for preliminary injunctions while repair, replacement, or refund is being sought.

Department of Transportation (DOT) is responsible for the U.S. program for ensuring the safe and environmentally sound transportation of hazardous materials by all modes of transportation through a comprehensive, risk-based, national program. The regulations apply to hazardous materials consignors, consignees, and carriers and manufacturers of hazardous materials packagings. DOT participates on the UN Economic and Social Council's Committee of Experts on the Transport of Dangerous Goods (UNCETDG). The work of the Committee has become increasingly important to both international and domestic transportation of hazardous materials to, from and within the United States. Virtually all hazardous materials imported to or exported from the United States are transported in accordance with international regulations based on the UN Recommendations.

Agency for Toxic Substances and Disease Registry (ATSDR) works to prevent exposure and adverse human health effects and diminished quality of life associated with exposure to hazardous substances from waste sites, unplanned releases, and other sources of pollution present in the environment. ATSDR performs public health assessments of waste sites, health consultations concerning specific hazardous substances, health surveillance and registries, response to emergency releases of hazardous substances, applied research in support of public health assessments, information development and dissemination, and education and training concerning hazardous substances.

National Institute of Environmental Health Sciences (NIEHS) works to reduce the burden of human illness and dysfunction from environmental causes by understanding the interactive elements: environmental factors, individual susceptibility and age and how they interrelate in human health and disease. NIEHS achieves its mission through multi-disciplinary biomedical research programs, prevention and intervention efforts, and communication strategies that encompass training, education, technology transfer, and community outreach.

Occupational Safety and Health Administration (OSHA) has a mission to save lives, prevent injuries and protect the health of America's workers. To accomplish this, federal and state governments must work in partnership with the more than 100 million working men and women and their six and a half million employers who are covered by the OSHA's statutory authorities. OSHA's establishes protective standards, enforces those standards, and reaches out to employers and employees through technical assistance and consultation programs. OSHA regulates chemical safety in the workplace. This is accomplished through a variety of regulatory approaches. There are chemical-specific standards that establish permissible exposure limits to control employee exposures. In some cases, these exposure limits are supplemented with specific requirements for exposure assessment, medical management, and other aspects of a control program. In addition to these chemical-specific requirements, the Agency also has many standards which address various aspects of chemical safety in the workplace. These include, for example, requirements for respiratory protection programs, handling and storage of flammable liquids, ventilation, and handling of chemicals in laboratory settings. OSHA also has a rule which requires the development and transmittal of information about all hazardous chemicals. The Hazard Communication Standard (HCS) requires chemical manufacturers and importers to evaluate the hazards of the chemicals they product or import, and to disseminate this information to their employer customers through labels on containers and material safety data sheets (MSDSs). All employers who have such chemicals in their workplaces are required to implement a hazard communication program to provide the information to their employees. Exposed employees are also required to be trained about the hazards and the available precautionary measures to prevent adverse effects from occurring.

National Institute for Occupational Safety and Health (NIOSH) is responsible for conducting research and making recommendations for the prevention of work­related illnesses and injuries. NIOSH identifies the causes of work­related diseases and injuries and the potential hazards of new work technologies and practices. With this information, NIOSH determines new and effective ways to protect workers from chemicals, machinery, and hazardous working conditions. NIOSH works to create new ways to prevent workplace hazards.

U.S. Agency for International Development (USAID) supports development assistance projects related to the sound management of chemicals as part of its sustainable development initiative. USAID will pursue an integrated approach to environmental issues as outlined in Agenda 21 of the UNCED (Earth Summit) guidelines for ecologically sustainable development. USAID will strengthen its institutional capacity to ensure that all Agency-supported efforts, whether projects or program-related investments, are environmentally sound. An important element of USAID's sustainable development program includes improving agricultural, industrial, and natural resource management practices that play a central role in environmental degradation.

U.S. Department of Commerce conducts in­depth analysis of the chemicals industry and identifies and promotes the development of domestic and international business opportunities. It provides industry analysis and statistical information, as well as business counseling and export assistance, and participates in domestic and foreign policy discussions affecting the U.S. chemicals industry.

6. INTERAGENCY COMMISSIONS AND COORDINATING MECHANISMS

There are a variety of coordinating mechanisms in place in the United States for chemical safety activities.

The U.S. National Focal Point for the Intergovernmental Forum on Chemical Safety (IFCS) is the EPA Assistant Administrator for Prevention, Pesticides and Toxic Substances (OPPTS). It is this official's responsibility, working with the State Department, other agencies, and stakeholders to ensure broad-based discussion of chemical safety issues and policy positions across the affected departments, agencies and non-governmental organizations. This coordination is achieved in part through meetings of interagency working groups. In addition, the National Focal Point meets separately with interested non-governmental organizations to seek their input prior to IFCS meetings and at other times as issues arise.

Special coordinating mechanisms are established between agencies as needed to address cross-agency issues, such as legislative and regulatory initiatives. In addition, Federal agencies consult with a variety of stakeholders groups and associations, including those representing state regulatory and enforcement interests for industrial chemicals and pesticides.

States and territories are true partners with EPA in protecting human health and the environment from pesticide risks. They assist in developing and implementing field programs, and they enforce OPP's regulations and pesticide labeling and use requirements. To further these common goals, OPP supports a cooperative agreement with the Association of American Pesticide Control Officials for the State FIFRA Issues Research and Evaluation Group (SFIREG). SFIREG meets regularly with OPP to develop pesticide programs and discuss implementation and enforcement issues of concern to the states and territories.

7. DATA ACCESS AND USE

Public and private entities in the United States have generated very extensive data sets and analyses of this information to manage chemical safety programs and activities. Regulatory agencies, such as EPA, generally have authority to require data submissions from industry that are needed to make regulatory decisions. There are also extensive data systems with information on approved chemicals, products and uses, though use information is generally limited to pesticides. The Toxics Release Inventory (TRI) (ref. Section 4(b)) provisions require certain facilities to annually report their releases and waste management information for listed chemicals. EPA then makes this information publicly available through TRI, which is a database that is accessible electronically. TRI operates under the community right-to-know principle by providing information on toxic chemical releases and waste management from companies.

Data are maintained within the research and regulatory program offices described in Chapter 5. In general, the U.S. Freedom of Information Act and related program policies make the data and agency analyses available to the public upon request, except for confidential business information as defined in the relevant statutes.

U.S. agencies are investigating ways of making data and other information on chemical safety available through the Internet Web or online networks. Information about and access to Federal government data sources has been greatly improved by the Government Information Locator Service (GILS) project. GILS is a decentralized collection of agency­based information locators and associated information services. GILS is intended to identify public information resources throughout the U.S. Federal government, describe the information available in those resources, and provide assistance in obtaining or accessing the information.

8. TECHNICAL INFRASTRUCTURE

The U.S. has invested heavily in public and private chemical safety laboratory facilities. These facilities generate the data needed to support government regulatory decisions on approval and safe use of chemicals, or, in the case of government laboratories, conduct research on chemical safety issues. Federal agencies with research responsibilities are described in chapter 5. Scientists at higher education institutions conduct extensive research on chemical safety. Private laboratory facilities develop the extensive data that pesticide registrants and other chemical industry sources are required to submit to EPA.

9. INTERNATIONAL LINKAGES

The U.S. is involved in a wide range of international activities and agreements, as indicated in

Chapter 9. The U.S. also participates in technical assistance projects world-wide related to chemicals safety. For example, chapter 9 describes Central American and Indonesian projects on pesticides that could serve as models for other regions of the world.

It is EPA's goal to share the burden of national chemical safety responsibilities within the Americas region and internationally to protect human health and the environment by using resources more effectively. This goal will be achieved by: (1) harmonizing regional approaches through the Intergovernmental Forum on Chemical Safety; (2) assisting countries in building national capacities and explaining U.S. programs and standards; and (3) informing other governments about U.S. pesticide exports and regulatory actions. The expected benefits of improved coordination and harmonization are: (1) improved food safety; (2) efficiencies gained through workload sharing among national regulatory agencies; (3) upgrading of supporting science through broader dialogues; and (4) fewer trade problems.

Cooperative bilateral efforts on chemical safety through the Canada/U.S. Trade Agreement (CUSTA) were recently expanded to include Mexico pursuant to the North America Free Trade Agreement (NAFTA). All three countries have much to gain from the work of a trilateral NAFTA. The goal of the expanded effort under NAFTA is to build the blocks necessary for the construction of an integrated, coordinated chemicals regulatory framework. The North American Working Group on the Sound Management of Chemicals has chosen four priority persistent and toxic substances for joint attention due to their potential risks: PCBs, DDT, chlordane and mercury. The U.S., Canada and Mexico intend to take action on a regional basis to reduce use/reliance on these chemicals and to replace them with safer alternatives.

10. RESOURCES AVAILABLE FOR CHEMICALS MANAGEMENT

EPA's obligations for pesticides and industrial chemicals regulatory, enforcement, and research activities in fiscal year 1995 were $117 million and 1003 workyears for pesticides and $148 million and 910 workyears for toxic substances. This does not include EPA resources for work on statutes related specifically to air, water or hazardous wastes. Other agencies involved in chemical safety, described in Chapter 5, also have substantial chemical safety budgets but these resources were not compiled as part of this profile. U.S. Federal agencies identify resource needs and priorities as part of the annual budget process in the Administration and the Congress.

11. RELEVANT ACTIVITIES OUTSIDE OF GOVERNMENT

There are many Non-Governmental Organizations (NGOs) that are active in the field of chemical safety in the U.S. A number of NGOs were asked to provide brief summaries of their chemical safety activities for inclusion in this profile and this information has been included in Chapter 11.

This listing should be considered only as an illustration of the many strong and diverse U.S. NGO chemical safety programs.

12. INFORMATION SHARING FOR WORKERS AND THE PUBLIC

EPA's extensive information sharing activities are described in Chapter 12, as well as the activities of several other agencies. Information on other government information sharing programs is described under the relevant agency in Chapter 5. EPA provides information to the general public, the press, State and local governments, EPA offices and regions, other Federal agencies, industry, grower groups, workers, certified applicators, trade and professional associations, environmental groups, public interest associations, libraries, researchers, international organizations, and foreign governments.

Many EPA clearinghouses and hotlines provide information on their area of expertise to the general public. The services send copies of regulations, guidance documents, and outreach material; loan videos; and answer questions or refer callers to sources of information on a more specific area.

EPA is implementing the Toxics Risk Management "Going Public" effort. The "Going Public" effort has two related goals. The first mission is to educate people so that they are cognizant of chemical risks and benefits. The first goal acts as a catalyst for the second goal, which is to have the public be an integral part of the regulatory process and help ensure that the government sets appropriate priorities and makes the best choices on toxics control. Informed people can also identify and solve local environmental problems without solely relying on government intervention and resources.

Appropriate outreach activities are vital to EPA's efforts to ensure that groups and individuals have the information they need to make responsible decisions about pesticides and promote public health and environmental protection goals. The challenge is to make information widely available, easily accessible, and suited to the needs of EPA's many publics. To accomplish this, the Office of Pesticide Programs (OPP) issues announcements and publications for both general and scientific audiences, provides information by telephone and electronic network, responds to written requests for information, maintains a public docket for walk-in visitors, holds public meetings, and presents speeches and Congressional testimony. OPP and other EPA offices respond to technical or complicated requests for information from the public under the Freedom of Information Act (FOIA). The majority of requestors receive all of the records requested, with the mo

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

st common requests to OPP being for science reviews of registration data, administrative files for pesticide products, and reregistration information.

OPP also has an extensive outreach effort to inform foreign governments about changes in the status of pesticides in the U.S. and major OPP programs. The purpose of these efforts is to help foreign governments, especially those that have not yet developed extensive pesticide regulatory and information-gathering programs, make informed choices about the use of pesticides in their countries. Not only do these efforts benefit citizens of foreign nations, but they also benefit Americans by helping to ensure the safety of imported food and other commodities treated with pesticides. In addition, these efforts help to protect wildlife, like migratory birds, that cross international borders.

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updated November 19, 1997