NATIONAL PROFILE ON MANAGEMENT OF CHEMICALS

January 1997

Office of Prevention, Pesticides and Toxic Substances

United Stated Environmental Protection Agency

Table of Contents

Introduction

Chapter 1: National Background Information

Chapter 2: Chemical Production, Import, Export and Use

Chapter 3: Priority Concerns Related to Chemical Production, Import, Export and Use

Chapter 4: Legal Instruments and Non-regulatory Mechanisms for Managing Chemicals

Chapter 5: Agencies Responsible for Chemical Safety Management

Chapter 6: Interagency Commissions and Coordinating Mechanisms

Chapter 7: Data Access and Use

Chapter 8: Technical Infrastructure

Chapter 9: International Linkages

Chapter 10: Resources Available for Chemicals Management

Chapter 11: Relevant Activities Outside Government

Chapter 12: Information Sharing for Workers and the Public

Annex A: Contact Points

U.S. NATIONAL PROFILE ON THE MANAGEMENT OF CHEMICALS

INTRODUCTION

The 1992 United Nations Conference on Environment and Development (UNCED) addressed a broad range of issues and presented findings and recommendations in the UNCED Agenda 21 report. Chapter 19 of Agenda 21 addressed opportunties to improve the sound management of chemicals at the national, regional and international levels.

Chapter 19 called for the creation of an intergovernmental forum to improve coordination and management of chemicals. This recommendation led to the creation of the Intergovernmental Forum on Chemical Safety (IFCS) in 1994. Program area E in Chapter 19 concerns the strengthening of national capabilities and capacities for the sound management of chemicals. The 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 and help guide U.S. chemical safety activities and coordination efforts. The National Profile has been developed by the U.S. Environmental Protection Agency in consultation with other U.S. partners involved in chemical safety management. The document follows an outline developed by the UN Institute for Training and Research (UNITAR). Modification have been made to this suggested format to accomplish the task with available resources in a way that will be useful in the U.S. context. This document will be revised and updated as needed to reflect changes in U.S. chemicals management activities. 

Dr. Lynn R. Goldman, M.D.

National IFCS Focal Point and

Assistant Administrator, U.S. EPA

Office of Prevention, Pesticides and Toxic Substances

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 fourth-largest 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 health-based 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 industry-by-industry, rather than by using the pollutant-by-pollutant approach of the past. Everyone concerned with a given industry--from manufacturers to community organizations--works 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 in-house expertise of its scientists and engineers with complementary research by universities and nonprofit organizations under a competitive, peer-review 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 radiation-emitting 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 over-the-counter 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 work-related illnesses and injuries. NIOSH identifies the causes of work-related 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 in-depth 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 agency-based 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 most 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.

CHAPTER 1: NATIONAL BACKGROUND INFORMATION

This chapter provides general background information on the United States to place chemical safety managment in the overall context of physical, political, demographic, industrial and agricultural characteristics of the country.

GEOGRAPHY:

Area: Total area: 9,372,610 sq km; Land area: 9,166,600 sq km

Comparative area: About half the size of Russia; about three-tenths the size of Africa; about one-half the size of South America (or slightly larger than Brazil); slightly smaller than China; about two and one-half times the size of Western Europe. Note: U.S. is world's fourth-largest country (after Russia, Canada, and China).

Climate: Mostly temperate, but tropical in Hawaii and Florida and arctic in Alaska, semiarid in the great plains west of the Mississippi River and arid in the Great Basin of the southwest; low winter temperatures in the northwest are ameliorated occasionally in January and February by warm chinook winds from the eastern slopes of the Rocky Mountains

Terrain: Vast central plain, mountains in west, hills and low mountains in east; rugged mountains and broad river valleys in Alaska; rugged, volcanic topography in Hawaii

Natural resources: coal, copper, lead, molybdenum, phosphates, uranium, bauxite, gold, iron, nickel, potash, silver, tungsten, zinc, petroleum, natural gas, timber

Land use: Arable land: 20%; Permanent crops: 0%; Meadows and pastures: 26%; Forest and woodland: 29%; Other: 25%.

PEOPLE:

Population: 263,814,032 (July 1995 est.)

Age structure: 0-14 years: 22%; 15-64 years: 65%; 65 years and over; 13% (July 1995 est.)

Population growth rate: 1.02% (1995 est.)

Birth rate: 15.25 births/1,000 population (1995 est.)

Death rate: 8.38 deaths/1,000 population (1995 est.)

Net migration rate: 3.34 migrant(s)/1,000 population (1995 est.)

Infant mortality rate: 7.88 deaths/1,000 live births (1995 est.)

Life expectancy at birth: 75.99 years; Male: 72.8 years; Female: 79.7 years (1995 est.)

Total fertility rate: 2.08 children born/woman (1995 est.)

Ethnic divisions: white 83.4%, black 12.4%, Asian 3.3%, Native American 0.8% (1992)

Languages: English, Spanish (spoken by a sizable minority)

Literacy: 97% of population age 15 and over has completed five or more years of schooling (1979)

Labor force: 131.056 million (includes unemployed) (1994)

By occupation: Managerial and professional 27.5%, technical, sales and administrative support 30.3%, services 13.7%, manufacturing, mining, transportation, and crafts 25.5%, farming, forestry, and fishing 2.9%

GOVERNMENT:

Type: Constitutional democracy with authority distributed between the central Federal government and the 50 states

Independence: 4 July 1776 (from England)

Constitution: 17 September 1787, effective 4 March 1789

Legal system: Separate State and Federal judicial systems established by applicable constitutions. The bulk of legal principles are codified and are loosely based on English common law.

Suffrage: 18 years of age; universal

Federal Executive branch: President is chief of state and head of government

Federal Legislative branch: Bicameral Congress -- Senate and House of Representatives

Federal Judicial branch: Supreme Court; Circuit Courts of Appeals; District Courts

ECONOMY:

Overview: The US has the most powerful, diverse, and technologically advanced economy in the world, with a per capita 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.

National product: Gross Domestic Product - purchasing power parity - $6.7384 trillion (1994)

Exports: $513 billion, including capital goods, automobiles, industrial supplies and raw materials, consumer goods, agricultural products; Principal Partners: Western Europe 24.3%, Canada 22.1%, Japan 10.5% (1993)

Imports: $664 billion, including crude oil and refined petroleum products, machinery, automobiles, consumer goods, industrial raw materials, food and beverages; Principal Partners: Canada, 19.3%, Western Europe 18.1%, Japan 18.1% (1993)

Industries: Leading industrial power in the world, highly diversified and technologically advanced; petroleum, steel, motor vehicles, aerospace, telecommunications, chemicals, electronics, food processing, consumer goods, lumber, mining.

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; surplus food producer; fish catch of 4.4 million metric tons (1990)

Communication: Telephone system: 126,000,000 telephones; 7,557,000 cellular telephones;

Intercity: large system of fiber-optic cable, microwave radio relay, coaxial cable, and domestic satellites; International: 16 satellites and 24 ocean cable systems in use; 61 INTELSAT (45 Atlantic

Ocean and 16 Pacific Ocean) earth stations (1990)

CHAPTER 2: CHEMICAL PRODUCTION, IMPORT, EXPORT AND USE

The purpose of this chapter is to provide basic information about the availability of chemicals in the United States and through export. The United States has a complex chemical industry structure and this version of the National Profile provides only very aggregate information. Chemicals are used by the general public in many facets of daily life at home and in the workplace.

The Organization for Economic Cooperation and Development (OECD) conducted an Environmental Peformance Reviewof the United States in 1996, which included the following snapshot overview of the U.S. chemical industry (ref. ISBN 92-64-14771-3, p. 177):

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.

This 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. Due to the multinational nature of chemical companies, about 29 per cent of the export/import transactions are considered intracompany shipments.

The following information is more detailed data from the U.S. Department of Commerce, which conducts surveys of industrial activity. The information varies somewhat from some of the information cited in the OECD report due to differences in coding, report dates and information sources. For example, the employment figure cited by OECD derives from the U.S. Department of Labor's Bureau of Labor Statistics. Department of Commerce's 1992 data are from the Census of Manufacturers and 1994 data are from the Annual Survey of Manufacturers (June 1996). Dollar values are provided rather than quantities due to limitations of the data, including the problem of reconciling liquid versus dry weights.

INFORMATION ON U.S. CHEMICAL INDUSTRY *

No. Of Facilities 10,600 (1992) 1994 not available

Employment 850,000 (1992) 824,000 (1994)

* Based on U.S. Standard Industrial Classification (SIC) Code 28: Chemicals, except where noted.

Value of Industry Shipments (billion dollars) (measure of output value)

All Chemicals $305.8 (1992) $333.3 (1994)

Value of Product Shipments (billion dollars) (measure of production/manufacturing)

Pesticides $9.2 (1992) $9.9 (1994)

Imports (billion dollars)

Pesticides 1992 not available $0.3 (1994)

Total Chemicals** $33.4 (1994)

Exports (billion dollars)

Pesticides 1992 not available $1.2 (1994)

All Chemicals** $51.6 (1994)

** Based on UN Standard International Trade Classification 5. Includes pesticides.

CHAPTER 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).

3.1 EPA DRAFT ENVIRONMENTAL GOALS FOR PESTICIDES AND INDUSTRIAL CHEMICALS PROGRAMS

EPA is developing in concert with other agencies draft goals and related milestones and strategies for EPA's pesticides and industrial chemicals programs. Each milestone will have associated indicators. The general goals are expected to include the following themes: (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.

3.2 GENERAL CHEMICAL SAFETY PROGRAM NEEDS

The following needs cross program boundaries.

3.2.1 Comprehensive Legislation.  

The current statutes and regulations in the United States were created at different times for a number of different specific concerns such as, air pollution, water pollution, solid waste problems, and worker protection. Some of these statutes generate conflicting regulations, some overlap in important areas without coordination. A comprehensive review of existing authorities with the purpose of simplifying multiple regulations, conflicts and overlapping jurisdictions would be beneficial. As these statutes are modified, EPA and other agencies will look for opportunities to coordinate them better. For example, the revisions to the Federal Insecticide, Fungicide and Rodenticide Act, the Federal Food Drug and Cosmetic Act, and the Safe Drinking Water Act in August 1996 provided the U.S. with an opportunity to link a number of the key provisions in these statutes (ref . Sections 4.4.3 and 5.1.3 for brief descriptions of these changes).

EPA's spending priorities during its first quarter century have often been based on the public's concern about specific pollutants rather than the risks of these sources of pollution. This response to public concern was natural given public uncertainties about true risks as the science of risk assessment has evolved. As a consequence, program investments do not always align well with actual risks. The U.S. is placing an emphasis on risk communication to educate the public about relative risks and is seeking to realign program priorities over time to correspond more closely with actual risks. One example of a shift in priorities is the relatively greater emphasis on worker protection from pesticides, due to their often high exposures and risks.

There is a continuing need for improvements in scientific processes to support risk reduction. As the scientific data base is made stronger, so is the basis for making cost-effective decisions protective of the environment and public health. EPA has a number of activities underway that represent next steps in the ever-evolving risk assessment process. All reflect greater complexity.

Significant initiatives to revise or develop procedures and methodologies are underway in the following areas: (1) proposed revisions to EPA's cancer risk assessment guidelines (April 1996); (2) extension of EPA's 1992 Framework for Ecological Risk Assessment to add specific risk assessment guidelines in 1996/1997; (3) implementation of EPA's 1995 policy directing all Agency programs to include the assessment of potential risk to children from environmental threats when developing a risk assessment and/or regulatory strategy, or explicitly state why it is not necessary or appropriate to include them; (4) implementation of EPA's recent risk characterization policy, which requires risk assessors to provide a clear, full and integrated assessment of an agent’s inherent toxicity, dose-response, anticipated consequences of human exposure; (5) development through EPA's Cumulative Risk Project of methodologies for assessing cumulative risks from all sources of exposure by developing risk assessment and regulatory approaches which transcend programmatic and legislative boundaries; (6) implementation of EPA's peer review policy, which requires each EPA program to determine the appropriate level of peer review for its assessments to ensure transparency and quality; (7) expanded research on endocrine disruption and continued national and international action to regulate chemicals identified as posing excessive risks.

If given adequate resources and time to use them in a reasonable way without restrictive legislative mandates, EPA can continue on the path of making the evolutionary changes called for in the science of risk assessment and consquently increase the level of chemical safety. These changes will ensure that risk assessment remains a key tool in the development of risk management decisions that are sound, flexible, fair, cost-effective and fully protective of human health and the environment.

There is also a need for a chemical data repository, common to all Federal agencies, containing hazard/risk information. This would save resources by avoiding redundant efforts and lead to more informed risk management decisions. EPA has the Integrated Risk Information System (IRIS) of chronic non-cancer and cancer health hazard information for over 500 substances. However, IRIS only contains data for which EPA has developed a position.

3.3 PRIORITY CONCERNS FOR EPA’S CHEMICAL SAFETY REGULATORY PROGRAMS

EPA's Office of Pesticide Programs (OPP) has identified a number of areas where improvements are needed 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.

• OPP needs a more stable funding base. Recent funding variabilitiy has clearly illustrated to all stakeholders the impact of financial instability on predictability of regulatory decisions and other outputs. The program should be based half on appropriations and half on fees. The 1996 amendments to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) described in Section 4.4.2 extended pesticide product registration maintenance fees through 2001, partially fulfilling the need for a more stable funding base.
• The last pesticide reregistration decision should be completed, achieving the 1988 statutory manadate to reregister all older pesticides with products first registered before October 1984.
• EPA will implement the significant changes to pesticide statutory authorities (FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA), see Section 4.4.2). The changes include a uniform health-based standard, consideration of new factors, including multiple exposures, sensitive subpopulations, and endocrine disruptors, review of all current tolerances (maximum residue levels) within 10 years, and a 15-year sunsetting provision for registration renewal. Successful implementation of these far-reaching changes will be a major challenge and opportunity for EPA.
• OPP will have a fully functioning stakeholders advisory committee with subcommittees addressing evolving issues. The first meeting of this new advisory committee is expected in 1996. This forum will provide an opportunity to educate stakeholders and achieve EPA/stakeholder cooperation on important policy issues, including particularly the implementation of the 1996 statutory revisions.
• The U.S. we will have a fully trained agricultural worker population, achieving significant risk reduction for this most exposed population. This will bring credibility to both registrants and regulators.
• OPP will process all new registration actions electronically, including electronic submission from registrants, automated processing in OPP and access to reviews and labels through Internet. There will be clear pesticide labels that will better inform and shape user behavior.
• There will be meaningful work sharing with other countries to take advantage of the high quality reviews being done by many countries. This builds on extensive harmonization efforts to date through OECD, NAFTA and other fora.
• The large majority of new pesticide active ingredients will be biopesticides or safer chemicals and EPA will continue to encourage these by providing expedited scientific review and regulatory decisions. Risk reduction will also be achieved through an expanded Pesticide Environmental Stewardship Program (PESP), establishing partnerships with grower organizations and others to reach measurable, voluntary risk reduction goals.
• The public will demand non-carcinogenic pesticides and focus on exposures other than food. OPP will need to strengthen consideration of household exposures, as well as drift, worker, and ecotoxicological end points. These exposure concerns are generally greater than those for food. OPP will clarify levels of concern for these areas and move toward greater protection.
• The U.S. will have a 24-hour toll-free hotline to respond to citizen concerns. The National Pesticides Telecommunication Network, an EPA contractor, has had to cut back its hours due to budget constraints. Many callers now get busy signals. The public has significant unmet needs for information on particular pesticide risks.
• There will be an updated National Food Consumption Survey and a more comprehensive Residue Data Base. This will assist EPA and stakeholders in addressing everything from more accurate market basket estimates to better anticipated residue estimates, resulting in better iterative risk assessments.
• EPA will provide free access to information by all interested parties. The public will be able to access tolerances, labels, science reviews and the status of registration and reregistration actions via Internet, customizing inquiries to find information of concern.

Experience gained during the past twenty years, since the enactment of the Toxic Substances Control Act (TSCA), have taught EPA three key lessons.

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.

The Organization for Economic Cooperation and Development's (OECD's) 1995 Environmental Performance Review of the United States recognized that the U.S. has developed a comprehensive approach to the management of industrial chemicals and pesticides and has had many achievements. It recommended the following as areas needing particular attention:

• simplify the pre-manufacturing notification system for new chemicals by further limiting the number of chemicals involved, and adding some test requirements;
• improve the effectiveness of the review program for existing chemicals by strengthening the coordination with other environmental programs and further defining goals to be reached within certain time frames;
• continue Federal and state authorities' efforts to ensure that pesticide safety information is fully accessible to and fully used by workers in agriculture;
• further improve coordination of chemical management activities at the Federal, state and local levels; and
• develop procedures that give more flexibility in taking action towards environmental goals for certain types of industries.

EPA is currently considering OECD's recommendations and will respond to them in 1997.

The Government Performance and Results Act of 1993 (GPRA) mandates the implementation of measurements-based evaluation plans for all program activities that appear in the budget of each Federal agency. Specifically, GPRA requires: (1) Strategic Plans; (2) Performance Plans; and (3) Annual Reports. All U.S. Federal agencies with chemical safety programs will be developing GPRA plans. This effort will greatly aid identification of high priority chemical safety activities across the Federal government and improve program accountability. The elements of GPRA implementation are described in more detail in the following sections.

Agencies must prepare five-year strategic plans setting forth their mission and long-term goals. The plans must include: (1) comprehensive mission statements; (2) goals and objectives; (3) approach that will be used in achieving the goals, including a schedule of significant actions and necessary resources; (4) description of key external factors that may significantly affect the achievement of goals and objectives; and (5) how program evaluations were used to develop the strategic plans. The first plans are due to OMB by September 30, 1997, cover at least five fiscal years forward, and be updated at least every three years.

Each agency must have an annual performance plan. This will establish a direct linkage between longer-term goals and what agency managers and staff are doing on a daily basis. These plans will generally be hierarchical in form, showing what annual performance goals need to be accomplished at each level for the next level to meet its goals. The plans will contain: (1) performance goals for programs; (2) summary of necessary resources, consistent with the President's Budget; (3) performance indicators that will be used to measure performance; (4) information on how measured values will be verified; and (5) proposed waivers.

Each Federal agency must do an annual program performance report to provide feedback to managers, policy makers and the public. The reports will indicate what was actually accomplished for the resources expended; how well the original goals were met; and why one or more goals were not met. The reports will also contain plans for achieving unmet goals or provide reasons why this is not possible, along with recommended actions. The reports will include program evaluation findings.

CHAPTER 4:
LEGAL INSTRUMENTS AND NON-REGULATORY MECHANISMS FOR MANAGING CHEMICALS

4.1 OVERVIEW OF NATIONAL LEGAL INSTRUMENTS WHICH ADDRESS CHEMICALS MANAGEMENT

This chapter provides an overview of U.S. Legal Instruments addressing chemical safety management. Section 4.4 provides detailed information on the industrial chemicals and pesticides regulatory programs in EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS). Chapter 5 provides brief descriptions of programs for all U.S. Federal agencies with a role in chemical safety managment, whether or not they have legal instruments described in the following tables. Regulatory citations are provided only for the statutes dealing most directly with pesticides and industrial chemicals. Statutory citations are provided in the United States Code (U.S.C.), in which U.S. public laws are codified. Regulatory citations are provided for the U.S. Code of Federal Regulations (CFR).

4.2 EXISTING LEGISLATION BY USE CATEGORY ADDRESSING VARIOUS STAGES OF CHEMICALS FROM PRODUCTION/IMPORT THROUGH DISPOSAL

NOTE: "X" indicates a specific stage is governed through legislation/regulation.

The following tables provide overviews of policy approaches and procedures used to control pesticides and industrial chemicals. Approaches to control of pharmaceuticals, veterinary drugs, fertilizer and petroleum are described generally in Chapter 5 under EPA and the Food and Drug Administration.

This section provides a description of legal instruments and related programs implemented by EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS). OPPTS has the principal responsibility in the U.S. for chemical safety managment through its two program offices: the Office of Pollution Prevention and Toxics and the Office of Pesticide Programs. Summary information on EPA and other Federal programs is contained in Chapter 5. Information on Non-Governmental Organizations’ activities is contained in Chapter 11.

4.4.1 Toxic Substances Control Act (TSCA):

EPA's Office of Pollution Prevention and Toxics (OPPT) oversees implementation of TSCA. TSCA was enacted in 1976 to identify and control industrial chemical hazards that present unreasonable risks to human health or 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, including to:

• Review new chemicals before they are manufactured or imported to prevent future chemical risks;
• Require industry to test selected new and existing chemicals for toxic effects;
• Gather information on chemical production, use, and possible adverse effects from those who manufacture, process, or distribute chemicals; and
• Control unreasonable risks of new or existing chemicals by taking a broad range of regulatory actions from requiring hazard-warning labels to outright bans on the manufacture, importation, processing, distribution, use, and/or disposal of especially hazardous chemicals. EPA may regulate these risks at any stage in a chemical's life cycle.

TSCA directs the agency 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. For example, the States review and approve or reject asbestos management plans that local educational agencies develop for school buildings. They adopt plans to give accreditation to certain asbestos contractors. The States also receive grants from EPA to develop and implement programs for the assessment and mitigation of radon. TSCA gives the States authority when their knowledge of local conditions is needed to control certain chemicals.

Under TSCA, EPA can inspect any establishment in which chemicals are manufactured, processed, imported to, or held before or after their distribution in commerce. No inspection shall include financial, sales, pricing, personnel, or research data, unless specified in an inspection notice. The Agency can subpoena witnesses, documents, and other information as necessary to carry out TSCA.

Civil actions concerning violations of or lack of compliance with TSCA may be brought to a U.S. district court to restrain or compel the taking of an action. Any chemical or mixture that was manufactured, processed, or distributed in commerce in violation of TSCA may be subject to seizure.

Specific enforcement strategies for implementing TSCA regulations have been developed by EPA. These strategies identify and rank possible violations of a particular regulation, identify the tools available for compliance monitoring and how they will be used, provide a formula for determining application of inspection resources, and establish policy for determining civil penalties under the regulation.

EPA/OPPT develops screening level and comprehensive risk assessments for new and existing chemicals. Of the approximately 450 staff in the office addressing TSCA issues, about 130 are technical and scientific personnel engaged in this work. Risk assessment activities encompass both human health and ecological risks. Risk assessments are prepared using the agency's Risk Assessment Guidelines. Risk assessment activities contribute information essential to the development and selection of risk management options and to guide implementation of risk reduction activities.

4.4.2 Pollution Prevention Act (PPA):

EPA/OPPT carries out the functions of PPA. The office is responsible for promoting pollution prevention that is defined as "source reduction" or "any practice which --

• (1) reduces the amount of any hazardous substance, pollutant, or contaminant entering any waste stream or otherwise released into the environment (including fugitive emissions) prior to recycling, treatment, or disposal and
• (2) reduces the hazards to public health and the environment associated with the release of such substances, pollutants or contaminants.

The term includes equipment or technology modifications, process or procedure modifications, reformulation or redesign of products, substitution of raw materials, and improvements in housekeeping, maintenance, training, or inventory control.

Under the act, facilities required to report releases to EPA for the Toxics Release Inventory (TRI) must also now provide information on pollution prevention and recycling, for each facility and for each toxic chemical. The information includes: the quantities of each toxic chemical entering the waste stream and the percentage change from the previous year, the quantities recycled and percentage change from the previous year, source reduction practices, and changes to production from the previous year.

4.4.3 Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and Federal Food, Drug and Cosmetic Act (FFDCA):

EPA's Office of Pesticide Programs (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). OPP has over 700 Headquarters staff, including over 300 scientists, who conduct comprehensive risk assessments for new and old pesticides and develop risk management decisions. 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. FIFRA authorities were strengthened through the 1970s in response to increasing public concern about the toxic effects of chemical pesticides. 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. The 1988 amendments included a provision for industry fees to cover approximately half the cost of the reregistration program. EPA has issued reregistration eligibility decisions for over one-third of the 400+ pesticide reregistration cases.

The Food Quality Protection Act (FQPA) of 1996 (P.L. 104-170, August 1996) amends both FFDCA and FIFRA to provide a more comprehensive and protective regulatory scheme for pesticides. Many of these changes are based directly on recommendations in the 1993 report of the National Research Council: "Pesticides in the Diets of Infants and Children." The FQPA's major changes are described later in this section.

FIFRA and FFDCA mandates 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. FIFRA and FFDCA require EPA to regulate the use of pesticides by balancing the risks and benefits posed by pesticides. The 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.

The Food and Drug Administration (FDA)(for most foods) and USDA (for meat, milk and eggs) 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. The Federal government assumes this responsibility when the States decide not to implement enforcement programs.

Some pesticides (Restricted Use Pesticides) may only be applied by or under the supervision of certified applicators. Applicator certification requirements are provided by regulation. Training programs are generally administered by state agricultural extension services with funding and technical support from EPA and USDA. There are over 1.3 million applicators holding valid certification, including both private (mostly farmers) and commercial applicators. In 1993, regulations requiring record-keeping by commercial applicators were strengthened, and similar record-keeping requirements were extended to private applicators. The expanded record-keeping is adding to survey and research information on pesticide use and effects. The information helps ensure that good agricultural practices are being followed, including strict adherence to label instructions, to avoid or minimize the occurrence of chemical residues on agricultural commodities, as well as minimizing risks to farmworkers, groundwater, and endangered species.

In 1992, EPA issued strengthened worker protection standards, replacing a 1974 regulation widely acknowledged to offer inadequate protection for agricultural workers. The new standards covers 3.9 million workers employed on farms, forests, nurseries, and greenhouses. The new standards will better protect the health of agricultural workers and handlers, reduce lost time from the job, and reduce medical expenses. The new standards are expected to reduce very significantly the number of reported and unreported acute pesticide poisoning incidents each year. The standards prevent or reduce exposure by setting specific requirements for restricted entry intervals and use of personal protective equipment. They mitigate exposure by requiring soap and water on-site, emergency transportation, and information. The standards also empower workers to help protect themselves by requiring safety training, safety posters and access to pesticide information. The new standards are directly enforceable. EPA has initiated a large outreach effort to educate employers and workers on the new requirements, including distribution of 1.5 million worker protection guides and 400 thousand pesticide guides.

To reduce worker exposure, the U.S. crop protection chemicals industry has created new types of pesticide mixing techniques that limit worker exposure to the particular product, including water soluble packaging and effervescent tablets, which both dissolve in water without the risk of touching the product and eliminate the need for container disposal.

Protection of ground water is a priority concern for EPA for both human health and environmental reasons. The centerpiece of OPP's ground-water strategy is a cooperative effort with the states and EPA regions to develop State Management Plans (SMPs) to prevent ground-water pollution from pesticides. Forty-four states have submitted draft "generic" SMPs, designed to create capacity for protecting ground water regardless of the particular pesticides used. The other six states are developing pesticide-specific plans in lieu of a generic plan. OPP published in June 1996 a proposed rule requiring SMPs for five widely-used herbicides frequently detected in ground water. Another important feature of OPP's ground water strategy has been to evaluate a pesticide's potential to contaminate ground water whenever OPP makes registration and reregistration decisions, with an emphasis on early mitigation of ground-water risks.

Endangered species may be harmed directly or indirectly by exposure to pesticides. The U.S. Fish and Wildlife Service (FWS) has issued assessments covering 32 chemicals and 400 species. Under the U.S. Endangered Species Act, EPA is required to ensure that the registration and use of pesticides is not likely to jeopardize endangered species. EPA is implementing an endangered species program that relies largely on product labeling and county bulletins.

The Food Quality Protection Act (FQPA) of 1996 (P.L. 104-170, August 1996) made significant revisions to both FFDCA and FIFRA to provide a comprehensive and protective regulatory scheme for pesticides. The FQPA's major changes are described in the following paragraphs.

Major FQPA Revisions to FFDCA

Health-Based Safety Standard for Pesticide Residues in Food: The new law establishes a strong, health-based safety standard for pesticide residues in all foods. It uses "a reasonable certainty of no harm" as the general safety standard. This single, health-based standard eliminates longstanding problems posed by multiple standards for pesticides in raw and processed foods. It requires EPA to consider all non-occupational sources of exposure, including drinking water, and exposure to other pesticides with a common mechanism of toxicity when setting tolerances.

Special Provisions for Infants and Children: The new law implements key recommendations of the National Academy of Sciences report, "Pesticides in the Diets of Infants and Children" by: (1) requiring an explicit determination that tolerances are safe for children; (2) including an additional safety factor of up to ten-fold, if necessary, to account for uncertainty in data relative to children; and (3) requiring consideration of children’s special sensitivity and exposure to pesticide chemicals.

Limitations on "Benefits" Considerations: Unlike previous law, which contained an open-ended provision for the consideration of pesticide benefits when setting tolerances, the new law places specific limits on benefits considerations.

Tolerance Reevaluation: Requires that all existing tolerances be reviewed within 10 years to make sure they meet the requirements of the new health-based safety standard.

Endocrine Disruptors: Incorporates provisions for endocrine testing, and also provides new authority to require that chemical manufacturers provide data on their products, including data on potential endocrine effects.

Enforcement: Includes enhanced enforcement of pesticide residue standards by allowing the Food and Drug Administration to impose civil penalties for tolerance violations.

Right to Know: Requires distribution of a brochure in grocery stores on the health effects of pesticides, how to avoid risks, and which foods have tolerances for pesticide residues based on benefits considerations. Specifically recognizes a state’s right to require warnings or labeling of food that has been treated with pesticides, such as California’s Proposition 65.

Uniformity of Tolerances: States may not set tolerance levels that differ from national levels unless the state petitions EPA for an exception, based on state-specific situations. National uniformity, however, would not apply to tolerances that included benefits considerations.

Major FQPA Revisions to FIFRA

Pesticide Reregistration Program: Reauthorizes and increases (from $14M to $16M per year) user fees necessary to complete the review of older pesticides to ensure they meet current standards. Requires tolerances to be reassessed as part of the reregistration program.

Pesticide Registration Renewal: Requires EPA to periodically review pesticide registrations, with a goal of establishing a 15-year cycle, to ensure that all pesticides meet updated safety standards.

Registration of Safer Pesticides: Expedites review of safer pesticides to help them reach the market sooner and replace older and potentially more risky chemicals.

Minor Use Pesticides: Establishes minor use programs within EPA and USDA to foster coordination on minor use regulations and policy, and provides for a revolving grant fund to support development of data necessary to register minor use pesticides. Encourages "minor use" registrations through extensions for submitting pesticide residue data, extensions for exclusive use of data, flexibility to waive certain data requirements, and requiring EPA to expedite review of minor use applications. These incentives are coupled with safeguards to protect the environment.

Anti-microbial Pesticides: Establishes new requirements to expedite the review and registration of anti-microbial pesticides.   Ends regulatory overlap in jurisdiction over liquid chemical sterilants.

FIFRA Implementation Responsibilities of EPA Regions and the States. EPA regions and State agencies are key players in FIFRA implementation. There are important pesticide regulatory and enforcement activities at the regional and state levels in the following areas: (1) worker protection; (2) protection of ground and surface water resources; (3) endangered species protection; and (4) certification and training (C&T). Field implementation of EPA's integrated pest management (IPM) and environmental stewardship initiatives is also of vital importance. Grants will continue to the Regions for IPM demonstration projects and environmental stewardship activities.

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. DPR has primary responsibility in California for regulating all aspects of pesticide sales and use to protect public health and the environment. DPR's mission is to evaluate and mitigate impacts of pesticide use, maintain the safety of the pesticide workplace, ensure product effectiveness, and encourage the development and use of reduced-risk pest control practices while recognizing the need for pest management in a healthy economy.

Before a pesticide can be sold or used in California, it has to be evaluated and registered by DPR. Pesticide manufacturers are required to submit studies of toxicology, efficacy, phytotoxicity, toxicity to non-target organisms, environmental fate, product chemistry, and residue methodology to support the registration of each product. The elaborate testing data are evaluated by DPR scientists, including biologists, chemists, plant physiologists, entomologists, toxicologists, and physicians. Much of the evaluation and scrutiny focuses on the acceptability of studies and any potential for these substances to cause adverse health or environmental effects, in order to ensure the proper, safe, and efficient use of pesticides. These and other data are the basis for determining potential risk and adequate margins of safety for workers and others who may be exposed to pesticide residues.

To assure compliance with its strong pesticide laws, California has a large enforcement staff. DPR oversees licensing and certification of dealers, pest control advisors, pest control businesses and applicators; has overall responsibility for pesticide incident investigations; administers the nation's largest state pesticide residue monitoring program; monitors pesticide product quality; and coordinates pesticide use reporting. Enforcement activities in the field are largely carried out by the county agricultural commissioners and their staffs, with training, coordination, and technical and legal support provided by headquarters personnel, as well as DPR field staff.

Cal/DPR Contact Information: California Department of Pesticide Regulation

1020 N Street, Room 100

Sacramento, CA 95814-5624

ph: (916) 445-4300      (916) 445-4300      

Internet address: www.cdpr.ca.gov

4.4.4 Emergency Planning and Community Right-To-Know Act

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 Toxic 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.

When Congress passed this legislation, it adopted two existing lists of chemicals -- one developed by the State of Maryland and the other by the State of New Jersey. In 1994, the agency expanded TRI to include 286 additional chemicals and chemical categories. The current list is comprised of more than 600 chemicals and chemical categories.

Initially, the TRI provisions applied to certain establishments operating in the manufacturing sector. In 1993, the President passed Executive Order 12856 that requires Federal facilities to report TRI information. In 1995, the President directed EPA to expedite rulemaking activities that would extend reporting to other private industry sectors. 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.

Affected establishments in all States must comply with regulations implemented by EPA. However, sixteen states passed their own legislation that either strengthens or makes procedural changes to the Federal program. For example, some states require additional facilities to report or include more chemicals, while others require companies to pay a fee based on the status of their emissions. Those states that adopted TRI-like laws have their own enforcement authority.

EPA enforces the TRI mandates under EPCRA. Section 325(c) of the law authorizes the EPA Administrator to assess civil administrative penalties for violations of EPCRA. For example, any person (owner or operator of a facility, other than a government entity) who violates any requirement of the TRI provisions is liable for a civil administrative penalty in an amount not to exceed $25,000 for each violation. Each day a violation continues may constitute a separate violation. The Administrator may assess the civil penalty by Administrative order or may bring an action to assess and collect the penalty in the U.S. District Court for the district in which the person from whom the penalty is sought resides or in which such person's principal place of business is located.

This section provides a description of non-regulatory approaches implemented by EPA and the Agency for Toxic Substances and Disease Registry (ATSDR). This indicates the broad range of U.S. non-regulatory approaches. Other non-regulatory approaches are described in Chapters 5 and 11.

4.5.1 Industrial Chemicals

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.

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 can be 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. The Agency 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.

EPA's Design for the Environment (DfE) program is another example of a voluntary risk reduction activity aimed at helping businesses incorporate environmental considerations into the design and redesign of products, processes, and technical and management systems. The DfE program works through voluntary partnerships with industry, professional organizations, state and local governments, other Federal agencies, and the public to promote safer substitutes, technologies, and chemical processes. These opportunities positively impact the health and safety of workers and consumers, and the environment. DfE programs include broad institutional projects aimed at changing general business practices, as well as more targeted joint projects with trade associations and businesses in specific industry segments.

The Screening Information Data Set (SIDS) program is a voluntary activity, coordinated by the Organization for Economic Cooperation and Development (OECD), under which the U.S. government and industry cooperatively test and assess high production volume chemicals. The U.S. contributes 25 percent of the chemicals handled by the OECD member countries.

Information dissemination has been found to be a valuable tool for obtaining results. Advisories have been used to warn the public of hazards from chemicals and to encourage 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.

The Agency for Toxic Substances and Disease Registry (ATSDR) has as a primary mission the development and dissemination of information on hazardous substances. The Toxicological Profiles are examinations and summaries of known toxicological information on individual substances. More concise information for hazardous substances is presented in the Public Health Statements and fact sheets, ToxFAQs.

Another important ATSDR activity is the education of physicians and other public health providers. The Case Studies in Environmental Medicine are designed to provide information on health effects and treatment for exposed individuals. The newsletter Hazardous Substances and Public Health presents current information in addressing public health issues associated with exposure to hazardous substances. ATSDR has also developed a planning guide for the management of chemically contaminated patients. The first in this series is directed to emergency medical service and the second is aimed at hospital emergency departments. Both guides have been illustrated in training videos.

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. In most cases, these changes are supported by extensive USDA/state-funded research and are based on IPM strategies for particular crops. Agricultural extension agents, funded by USDA and the states, help transfer new technologies and practices to growers. Industry and grower-supported research efforts have also helped accelerate the transition to new practices.

The U.S. government has a close working relationship with industry, environmental and scientific Non-Governmental Organizations (NGOs). NGO support is essential for the successful implementation of legal instruments and non-regulatory mechanisms described in this chapter. NGO initiatives often chart new directions in non-regulatory mechanisms to manage chemical risks. The wide range of NGO organizations involved in chemical safety management and a brief description of their activities are described in Chapter 11.

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

This chapter briefly describes the multi-faceted mandates and programs of the U.S. agencies responsible for and concerned with various aspects of chemicals management. The tables in each section contain an "X" for areas governed by the agency through legislation/regulation. Chapter 4 contains additional information on statutory and regulatory citations and program coverage.

Four 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. Therefore, OSHA can provide information on the potential adverse effects of chemicals in the manufacturing or processing stage of their life cycle. 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. 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 sections provide brief overviews of the responsibilities and programs of the U.S. agencies responsible for some aspect of chemical safety management.

[NOTE: EPA offers extensive information on its programs through its Internet Web site at www.epa.gov.]

5.1.1 EPA Overview

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 industry-by-industry, rather than by using the pollutant-by-pollutant approach of the past. Everyone concerned with a given industry--from manufacturers to community organizations--works 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 in-house expertise of Agency scientists and engineers with complementary research by universities and nonprofit organizations under a competitive, peer-review extramural program.

EPA administers eleven comprehensive environmental protection laws: the Clean Air Act; the Clean Water Act; the Safe Drinking Water Act; the Comprehensive Environmental Response, Compensation, and Liability Act ("Superfund"); the Resource Conservation and Recovery Act; the Federal Insecticide, Fungicide, and Rodenticide Act; the Toxic Substances Control Act; the Uranium Mill Tailings Radiation Control Act; the Lead Contamination Control Act; the Ocean Dumping Ban Act; and the National Environmental Education Act.

EPA is directed by an Administrator and a Deputy Administrator, both appointed by the President with the advice and consent of the Senate. Nine Assistant Administrators, the Agency's General Counsel, and its Inspector General, also are named by the President and are subject to Senate confirmation. The nine Assistant Administrators manage specific programs, such as those protecting the air, water, and land of Americans, or direct other Agency functions, such as enforcement of environmental laws. Three Associate Administrators are named by the Administrator to carry out programs for public affairs, congressional and legislative relations, and regional, state, and local relations. Ten Regional Administrators work closely with state and local governments to carry out the Agency mission.

OPPTS carries out a broad pollution-prevention program as well as regulating pesticides and industrial chemicals. Prevention is a top priority for EPA, and is supported by the Pollution Prevention Act of 1990. It is a common-sense, cost-effective approach to protecting the health of our communities. For instance, EPA's 33-50 program provides incentives to lessen industrial output of 17 toxic substances--by 33 percent in 1992 and 50 percent in 1995. Since 1991, over 1300 companies have joined and committed to reductions of 355 million pounds of toxic waste. The goal was to eliminate more than 740 million pounds of pollutants by the end of 1995. Their efforts helped the 33/50 program reach its 50% goal a year ahead of schedule.

Besides pollution prevention, OPPTS has been entrusted with the responsibility to safeguard Americans and the environment from risks posed by pesticides. Pesticides are used in a remarkably diverse array of products, from insect repellents to crop weed killers, household disinfectants, and swimming pool chemicals. They are likely to be found in nearly every U.S. home and business. While pesticide use has contributed to increased agricultural production and improved public health through control of disease-carrying pests, acute and chronic human health and environmental risks also can be associated with use of many of these chemicals. In determining whether to permit the marketing of a pesticide and how to regulate its use, EPA balances the potential risks against the benefits to be gained. EPA has developed an array of programs to perform such evaluations.

At the core of these programs are efforts to regulate the use of pesticides and residues that may remain in food. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA "registers" new pesticides to ensure that, when used according to label directions, they will not cause unreasonable adverse effects to human health or the environment. No pesticide may be sold for use in the U.S. unless it is registered by EPA and bears an EPA-approved label.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA establishes "tolerances", or maximum limits, for pesticide residues in food or animal feed. These tolerances are enforced by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). FDA and USDA monitor both domestically produced and imported foods in interstate commerce.

The Food Quality Protection Act of 1996 (P.L. 104-170, August 1996) made significant revisions to both FFDCA and FIFRA to provide a comprehensive and protective regulatory scheme for pesticides. The major changes are described in Section 4.4.3.

Another major program within OPPTS is carrying out the Toxic Substances Control Act (TSCA), intended to identify and control chemicals that pose an unreasonable risk to human health or the environment through processing, commercial distribution, use, or disposal. Most chemicals do not endanger our health or the environment if used properly. Some are so toxic, however, that even in minute amounts they can cause death, disease, genetic damage, or severe environmental harm. Toxic substances include a number of manufactured chemicals, as well as naturally occurring heavy metals and other materials. Some toxic substances, such as lead, asbestos, and polychlorinated biphenyls (PCBs), have caused serious health problems.

One of the office's major regulatory tools under TSCA is the premanufacture notification process, under which manufacturers are required to notify the office at least 90 days before producing or importing a new chemical substance. This notification enables the Agency to assess the risk of a new chemical before manufacture begins. If a chemical substance is suspected of posing an unreasonable risk, but key data are missing, EPA may require manufacturers to test the substance for toxicity, cancer-causing potential, reproductive effects, or other characteristics.

Under TSCA, EPA can require the chemical industry to conduct needed testing on existing chemicals. An Interagency Testing Committee (ITC) of government experts advises EPA as to the existing chemicals that should be tested. The full array of needed teting (including the recommendations of the ITC) is presented on the "Master Testing List." Under TSCA, EPA also can obtain reporting by industry on production, uses, and exposures of chemicals. Substances found to present an unreasonable risk can be regulated to minimize or eliminate the risk.

OPPTS ADDRESSES:

EPA Office of Prevention, Pesticides and Toxic Substances (Mail Code 7101)

401 M Street, S.W.

Washington, DC 20460 Ph: (202) 260-2902              (202) 260-2902; Fax: (202) 260-1847

EPA/OPPTS Office of Pollution Prevention and Toxics (OPPT) (Mail Code 7401)

401 M Street, S.W.

Washington, DC 20460 Ph: (202) 260-3810              (202) 260-3810; Fax: (202) 260-0575

EPA/OPPTS Office of Pesticide Programs ( OPP) (7501C)

401 M Street, S.W.

Washington, DC 20460 Ph: (703) 305-7090              (703) 305-7090; Fax: (703) 308-4776

OW administers the Safe Drinking Water Act, establishing national limits on maximum contaminant levels for chemicals in drinking water, such as fluoride, mercury, PCBs, and lead. The states are primarily responsible for enforcing the standards, but get EPA financial assistance. There were major revisions to SDWA enacted in August 1996. In summary, these 1996 changes accomplished the following: (1) requires local water authorities to disclose annually which chemicals and bacteria are in drinking water and improvements in the 24-hour notification process after discovering a dangerous contaminant in the water system; (2) establishes a framework for pollution prevention by requiring an assessment of threats and providing funding for state source water protection efforts, and through new requirements for state programs for water system capacity development and operator certification, designed to help systems avoid problems and prepare for the future; (3) considers the special needs of children, the elderly, and people living with AIDS and weak immune systems; (4) focuses water authorities' attention on preventing and treating the most harmful pollutants in tap water, such as cryptosporidium, rather than placing the highest priority on identifying new pollutants; and (5) authorizes $7.6 billion over seven years for a revolving loan fund to improve badly deteriorating water systems throughout the country.

In addition to guarding drinking water from contaminants, EPA carries out an extensive program to protect the health of our water bodies, including our rivers, lakes, and beaches. Its pollution prevention program is based on the Clean Water Act. This act requires each state to set water-quality standards for every significant body of surface water within its borders. It also requires that all publicly owned municipal sewage systems provide secondary treatment of wastewater (a biochemical process) before it is discharged. To ensure that communities meet treatment requirements, sewage facilities must secure permits specifying the types and amounts of pollutants that may be discharged under the National Pollutant Discharge Elimination System.

Industries discharging pollutants into waterways or publicly owned sewage systems are also subject to controls, with an ultimate goal of completely eliminating the discharge of pollutants into the Nation's waters. Nationwide discharge standards are established by EPA for categories of industries, with requirements tailored to the availability and economic feasibility of control technology. Standards also have been established for stormwater discharges from pipes separate from sewage systems. Stormwater discharges transport large quantities of pollutants to waterways and have been linked to one-third of all evaluated degradations of surface-water quality nationwide. Sources of contaminated stormwater include urban runoff, runoff from farms and lawns, industrial activities, construction, mining and other types of resource extraction, and various commercial activities.

The Clean Water Act also is implemented through two programs operated jointly by EPA and the U.S. Army Corps of Engineers. Under the dredge and fill system, waters are protected against degradation caused by disposal of dredged spoils or fill. The two agencies also jointly protect and restore critical and productive wetlands, which filter pollutants, slow flood waters, and recharge vital aquifers. Wetlands are the basis of many thousands of jobs, and contribute billions of dollars to the economy. For example, in the Southeastern United States, over 90 percent of the commercial catch of fish and shellfish depends on coastal wetland systems.

Additionally, water quality is protected by nearly all of the laws EPA administers. Air pollution controls, for example, keep harmful pollutants from entering the water from the atmosphere. Laws governing radiation, industrial substances, and pesticides also safeguard water quality. In addition, a major Agency objective is to prevent contamination of groundwater and surface waters by seepage of harmful substances from solid-waste disposal sites.

EPA Office of Water (Mail Code 4101)

401 M Street, S.W.

Washington, DC 20460 Ph: (202) 260-5700              (202) 260-5700; Fax: (202) 260-5711

OAR also develops protection criteria, standards and policies and works with other programs within EPA and other agencies to control radiation and indoor-air-pollution exposures, including pollution from pesticides and industrial substances. It also provides technical assistance to states through EPA's regional offices and other agencies having radiation and indoor air protection programs, directs a program that monitors environmental radiation, responds to radiological emergencies, and evaluates and assesses the overall risk and effect of radiation and indoor-air pollution.

EPA Office of Air and Radiation (Mail Code 6101)

401 M Street, S.W.

Washington, DC 20460 Ph: (202) 260-7400             (202) 260-7400; Fax: (202) 260-5155

OSWER protects the environment through several laws: the Resource Conservation and Recovery Act (RCRA) of 1976, the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, or "Superfund") of 1980, the Emergency Planning and Community Right-to-Know Act of 1986, and the Oil Pollution Act of 1990.

Congress passed RCRA because it was concerned about the management of hazardous waste, the careless disposal of which can lead to the contamination of whole communities. At Love Canal in New York, for example, hazardous waste buried over a 25-year period contaminated ground and surface water and finally forced the evacuation of an entire neighborhood. EPA's major emphasis under RCRA has been to develop a "cradle-to-grave" system to ensure that hazardous waste is managed in a manner that protects human health and the environment from generation through its storage, transport, treatment, and ultimate disposal. The RCRA program includes oversight of underground storage tanks for petroleum or such hazardous compounds as benzene. EPA also regulates current and future waste-management and disposal practices.

Congress established the Superfund program in 1980 to deal with the legacy of abandoned waste sites or emergencies created by spills or other releases of hazardous substances. A Trust Fund was set up to pay for the cleanup of these sites, financed mainly by taxes on the chemical and petroleum industries. The Superfund program has been effective in developing new technologies for more effective cleanups. EPA has already removed almost 24,000, or about two-thirds of the sites from the Superfund Inventory. These sites were screened and determined to require no more federal review. Removal of these properties from the national inventory is the first step in opening the way for property to be brought back into productive community use.

In response to the growing concern for the potential for accidents involving extremely hazardous substances, Congress enacted the Emergency Planning and Community Right-to-Know Act. This law makes citizens full partners in preparing for emergencies and managing chemical risks. The provisions of the Community Right-to-Know Act allow the public to obtain information about the presence of hazardous chemicals in the community and their release into the environment.

The Oil Pollution Act (OPA) of 1990 was passed largely as a result of the Exxon Valdez incident in 1989. The Exxon tanker Valdez dumped 11 million gallons of crude oil into Alaska's Prince William Sound. OPA was designed to improve the Nation's ability to respond to marine and inland oil spills. It amended section 311 of the Clean Water Act of 1972, which addresses pollution from oil. The Oil Pollution Act has provisions in areas of prevention, preparedness and response, liability, and research and development. EPA is responsible for regulating facilities and responding to inland spills while the Coast Guard is responsible for marine spills.

EPA Office of Solid Waste and Emergency Response (Mail Code 5101)

401 M Street, S.W.

Washington, DC 20460 Ph: (202) 260-4610              (202) 260-4610; Fax: (202) 260-3527

OECA enforces hundreds of regulations safeguarding our air, water, and land. The term "enforcement" covers all efforts to encourage compliance with environmental laws. "Compliance" refers to the condition that exists when a person or company fully obeys the law. Enforcement responses could take the form of warning letters, fines, and even imprisonment in such criminal actions as "midnight dumping" of toxic substances. The office provides case preparation and investigative expertise through the National Enforcement Investigations Center to Agency headquarters, regions, and states. The center's combination of laboratory, investigative, and engineering skills is often instrumental in developing evidence for civil and judicial proceedings. The office also oversees the National Enforcement Training Institute, which directs the development of a curriculum that addresses the training needs of all members of the enforcement and compliance team (i.e., investigators, inspectors, regulators, prosecutors, and support personnel). In addition, the office manages the National Environmental Policy Act and directives regulating the environmental actions of other federal agencies.

EPA Office of Enforcement and Compliance Assurance (Mail Code 2201)

401 M Street, S.W.

Washington, DC 20460 Ph: (202) 260-4134          (202) 260-4134; Fax: (202) 260-0500

ORD conducts the scientific and engineering studies needed by EPA for effective, forward-looking policymaking. ORD's structure is designed to meet EPA's need for new data, methods, technologies, and risk assessments to reduce uncertainties about complex environmental problems and address areas of highest concern. Major areas of study involve exposure of people and the environment to pollutants and other stressors, the effects of pollutants and other stressors, and assessment and management of environmental risks. ORD's efforts involve the work of EPA's own scientists at 12 U.S. laboratory facilities. This in-house research is complemented by a competitive extramural program that enlists the talents of universities and nonprofit organizations. ORD maintains a rigorous peer-review program to ensure the scientific soundness of its work, and collaborates with other Federal research agencies to pool resources for addressing issues of mutual concern.

EPA Office of Research and Development (Mail Code 8101)

401 M Street, S.W.

Washington, DC 20460 Ph: (202) 260-7676             (202) 260-7676      ; Fax: (202) 260-9761

OIA leads EPA's international programs. OIA works closely with EPA program and regional offices, other federal agencies, international organizations, and foreign governments to achieve U.S. environmental objectives overseas. This role assures that EPA speaks with one voice on international policy. OIA is also actively involved in technical assistance cooperation programs, often involving U.S. Agency for International Development funding, that are designed to assist countries to develop environmental management capacity. OIA has managed the development of a number of training models, including one on risk assessment. Much of OIA's recent work relating to chemicals has been in the area of lead risk reduction, including the delivery of training programs in Russia and Latin America.

EPA Office of International Activities (Mail Code 2610)

401 M Street, S.W.

Washington, DC 20460 Ph: (202) 260-4870              (202) 260-4870; Fax: (202) 260-4470

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. The State Department also funds a number of international programs and helps coordinate Federal agency funding of particular international chemical safety activities.

Office of Environmental Policy, U.S. Department of State

Room 4325 Main State

Washington, D.C. 20520 Ph: 202-647-9266              202-647-9266; Fax: 202-647-5947

5.3 FOOD AND DRUG ADMINISTRATION (FDA)

FDA is an agency within the Public Health Service, which in turn is a part of the Department of Health and Human Services. FDA has approximately 9,000 employees that regulate over $1 trillion worth of products. 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 radiation-emitting 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.

First and foremost, FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act (FFDCA) and several related public health laws. These laws apply equally to domestic and imported products. To carry out this mandate of consumer protection, FDA has some 1,100 investigators and inspectors to ensure that products are made right and labeled truthfully. If a company is found violating any of the laws that FDA enforces, FDA can encourage the firm to voluntarily correct the problem or to recall a faulty product from the market. A recall is generally the fastest and most effective way to protect the public from an unsafe product. When a company cannot or will not correct a public health problem with one of its products voluntarily, FDA has legal sanctions it can bring to bear. The agency can go to court to force a company to stop selling a product and to have items already produced seized and destroyed. When warranted, criminal penalties--including prison sentences--are sought against manufacturers and distributors.

About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. In addition, about 30,000 import shipments a year are detained at the port of entry because the goods appear to be unacceptable.

The scientific evidence needed to back up FDA's legal cases is prepared by the agency's 2,100 scientists, including 900 chemists and 300 microbiologists, who work in 40 laboratories in the Washington, D.C., area and around the country. Some of these scientists analyze samples to see, for example, if products are contaminated with illegal substances. Other scientists review test results submitted by companies seeking agency approval for drugs, vaccines, food additives, coloring agents and medical devices. Assessing risks -- and, for drugs and medical devices, weighing risks against benefits -- is at the core of FDA's public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they're buying. For example, the agency requires that drugs--both prescription and over-the-counter--be proven safe and effective. In deciding whether to approve new drugs, FDA does not itself do research, but rather examines the results of studies done by the manufacturer. The agency must determine that the new drug produces the benefits it's supposed to without causing side effects that would outweigh those benefits.

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 over-the-counter medicines for humans through its Center for Drug Evaluation and Research. The center's mission is to: (1) approve drugs for marketing that are effective for their labeled indications, provide benefits that outweigh their risks, are of high quality, and have directions for use that are complete and honestly communicated; (2) facilitate early access to promising experimental drugs being developed for serious illnesses with no adequate therapy; (3) promote innovation and provide scientific leadership in the drug development process; (4) ensure that the safety and rights of patients in drug studies are adequately protected; and (5) ensure that the quality and safety of medicines are maintained after marketing.

The safety of the nation's blood supply is another FDA responsibility. The agency's investigators routinely examine blood bank operations, from record-keeping to testing for contaminants. FDA also ensures the purity and effectiveness of biologicals (medical preparations made from living organisms and their products), such as insulin and vaccines.

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.

For more information, see FDA's Internet home page: http://www.fda.gov/fdahomepage.html.

Food And Drug Administration

International Affairs Office

5600 Fishers Lane, 15930

Rockville, MD 20857 Ph: (301) 443-2410              (301) 443-2410     

5.4 U.S. DEPARTMENT OF AGRICULTURE (USDA)

The 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. EPA and USDA signed a Memorandum of Understanding in August 1994 on research, technology transfer, and registration of new alternatives for important pesticide uses that may be lost. USDA enforces tolerance 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. Examples of USDA programs supporting chemical safety are described below:

• The USDA/State-funded IR-4 program was established in 1963 to develop residue data for high priority crops that are minor uses of pesticides, thereby overcoming a significant portion of the economic disincentives facing minor use registrants. See Section 8.2 for more information on IR-4.
• EPA works with USDA's National Agricultural Pesticide Impact Assessment Program (NAPIAP) to provide early notification through the NAPIAP network to growers about decisions by pesticide registrants not to support product reregistration, particularly in cases where this would mean the loss of an entire pesticide active ingredient. Grower groups may then arrange for other support to develop required data for the most important minor uses.
• The Sustainable Agriculture Research and Education (SARE) program is a USDA grant program managed through four regional councils composed of farmers and ranchers, and representatives of non-profit private, agribusiness, government and academic organizations. Most funded projects involve farmers or ranchers. Sustainable agriculture teams are used to conduct site visits to review progress and evaluate continued funding. SARE places special emphasis on whole-farm systems research and economic impact assessment. An integrated decision-support system (PLANETOR) was developed as a national initiative for assessment of on-farm economics.
• The Integrated Farm Management Program Option (IFMPO) supports IPM and sustainable agriculture by encouraging crop rotation for farmers participating in the USDA commodity price support program. The goal of the IFMPO is to reduce commodity program barriers that discourage adoption of sustainable agricultural practices. It is a voluntary program that protects farm program payments to farmers who incorporate resource-conserving crops as part of a rotation on payment acreage.
• USDA is developing Federal standards for certifying farms, producers, and processors as "organic," allowing them to use organic labels under the authority of the Organic Foods Production Act of 1990. Several states already have organic certification programs in place. In particular, the California Organic Foods Act of 1990 established a system for certifying food as organically grown, produced, and processed.

USDA offers extensive information on its programs at Internet Web site: http://www.usda.gov.

USDA Office of the Assistant Secretary for

Natural Resources and Environment

14th and Independence Ave., S.W.

Washington, D.C. 20250 Ph: (202) 720-5166             (202) 720-5166; Fax: (202) 720-4732

5.5 CONSUMER PRODUCT SAFETY COMMISSION (CPSC)

The CPSC has a role in chemical safety management under the authority of the Federal Hazardous Substances Act (FHSA), the Consumer Product Safety Act (CPSA), and the Poison Prevention Packaging Act (PPPA) (ref. Chapter 4 for citations). 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.

CPSC has an excellent capacity for risk assessment ranging from developing test guidelines to conducting quantitative risk asessments and interpretations. CPSC's risk management policies range from labeling to development of performance standards or bans. The risk management policy may include hazard identification, exposure assessment, dose response assessment, risk characterization, and cost benefit analysis.

Sources of consumer product safety information include CPSC's data systems (e.g. National Electronic Injury Surveillance System and Hot Line), poison control centers, other government agencies, industry, the public and published literature.

CPSC has publications specifically designed for consumers and affected industries and these are widely distributed. Multimedia communication programs (using radio, TV, newspaper, magazine, and state and local networks) reinforce media messages with follow-up publications and safety workshops. CPSC regularly provides safety information to state legal staffs, health departments, and consumer protection offices. CPSC also has a number of "information superhighway" communication methods, such as a toll-free Hotline, a fax-on-demand service, and Internet gopher services at the following address: gopher://cpsc.gov.

Consumer Product Safety Commission

Office of the Secretary

Washington, D.C. 20207 Ph: (301) 504-0800              (301) 504-0800 Email: info@cpsc.gov

5.6 DEPARTMENT OF TRANSPORTATION

The U.S. 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. DOT derives its authority from the Hazardous Materials Transportation Act and associated regulations (ref. Chapter 4). The regulations apply to hazardous materials consignors, consignees, and carriers and manufacturers of hazardous materials packagings. The Act provides DOT the authority to enforce its regulations through a system of civil and criminal penalties. The regulations are enforced by the DOT Research and Special Programs Administration, the Federal Aviation Administration, the Federal Railroad Administration, the Federal Highway Administration, the United States Coast Guard and state and local enforcement officials.

DOT participates on the UN Economic and Social Council's Committee of Experts on the Transport of Dangerous Goods (UNCETDG). This Committee provides leadership in internationally harmonizing regulations on the safe transportation of hazardous materials (dangerous goods) by developing an internationally agreed regulatory framework set out in the United Nations Recommendations on the Transport of Dangerous Goods. These Recommendations form the basis for international modal regulations on the transport of dangerous goods prepared by the International Maritime Organization (IMO) and the International Civil Aviation Organization (ICAO). The UN Recommendations are also used as a basis for the development of regional (e.g., NAFTA and European Road and Rail regulations) and national transport regulations, including the U.S. Hazardous Materials Regulations. The UN Recommendations cover all aspects of transportation necessary to provide international uniformity. They include a comprehensive criteria based classification system for substances that pose a significant hazard in transportation. Hazards addressed include explosivity, flammability, toxicity (oral, dermal and by inhalation), corrosivity to human tissue and metal, reactivity (e.g., oxidizing materials, self reactive materials, pyrophoric substances, substances that react with water), radioactivity, infectious substance hazards and environmental hazards. They prescribe standards for packagings and multimodal tanks used to transport hazardous materials. They also include a system of communicating the hazards of substances in transport through hazard communication requirements which cover labelling and marking of packages, placarding of tanks and freight units, and documentation and emergency response information that is required to accompany each shipment.

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. In the case of the U.S., the decisions of the UN Committee affect an international trade volume in hazardous materials with a dollar value of $71 billion annually. In addition to enhancing safe transportation through improved regulatory consistency, international harmonization of hazardous materials regulations has played a significant role in maintaining the U.S. favorable balance of trade in chemicals ($17 billion annually). The work of the Committee also affects a much larger domestic hazardous materials transportation volume.

In addition to substances subject to the UN Recommendations, DOT also regulates substances which react with water to give off toxic gases, environmentally hazardous substances identified by the EPA under the Comprehensive Environmental Response, Compensation and Liability Act and hazardous wastes identified by the EPA under the Resource Conservation and Recovery Act.

While the U.S. DOT does not directly respond to incidents or accidents involving hazardous materials as this is typically the responsibility of local emergency services, its regulations require the availability of emergency response information with each hazardous materials shipment and DOT publishes an emergency response guidebook which provides initial responders to hazardous materials accidents with appropriate response steps to take in the initial stages of an accident. A similar guidebook will be published in 1996 jointly by the U.S. DOT and its counterparts in Canada and Mexico. DOT is also a member of the multi agency National Response Team which supports local and regional response teams in making emergency response resources available in the event of major releases of hazardous materials or oils. Information on the hazardous materials regulations is disseminated through required training courses, DOT literature and through publicly or DOT sponsored conferences. DOT continues to work toward improving the effectiveness of its hazardous materials program. The efforts currently include work toward more fully integrating formal risk analysis into its regulatory process and electronically transmitting emergency response information to emergency responders.

DOT offers information on its programs at Internet site: http://www.dot.gov.

Research and Special Programs Administration

Room 8410, DRP-1

Department of Transportation

4000 7th Street

Washington, DC 20590 Ph: (202) 366 4433              (202) 366 4433

5.7 AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY

The mission of the Agency for Toxic Substances and Disease Registry (ATSDR), as an agency of the Public Health Service in the U.S. Department of Health and Human Services, is 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 is directed by congressional mandate to perform specific functions concerning the effect on public health of hazardous substances in the environment. These functions include 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.

ATSDR works closely with the Centers for Disease Control and Prevention (CDC) and the National Institute of Environmental Health Sciences (NIEHS). The Environmental Protection Agency (EPA) is also concerned with the same sites at which ATSDR performs health assessments.

ATSDR offers more detailed information about its programs and access to its data bases on its Internet Web site (ref. http//atsdr1.atsdr.cdc.gov:8080/). HazDat, ATSDR's Hazardous Substance Release/Health Effects Database, is the scientific and administrative database developed to provide access to information on the release of hazardous substances from Superfund sites or from emergency events and on the effects of hazardous substances on the health of human populations. HazDat contains summary information for the health assessments and health consultations provided by the agency. ToxFAQs are short, easy-to-read summaries about hazardous substances that have been excerpted from the ATSDR Toxicological Profiles. Public Health Statements, taken from Toxicological Profiles, offer easy-to-read summaries of many hazardous substances to which people might be exposed.

ATSDR Office of the Assistant Administrator

1600 Clifton Rd (E28)

Atlanta, GA. 30333 Ph: (404) 639-0700              (404) 639-0700    Fax: (404) 639-0744

5.8 NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS)

NIEHS is one of 24 components of the National Institutes of Health (NIH), which is a component of the Public Health Service (PHS) in the U.S. Department of Health and Human Services. Human health and human disease result from three interactive elements: environmental factors, individual susceptibility and age. The mission of NIEHS is to reduce the burden of human illness and dysfunction from environmental causes by understanding each of these elements and how they interrelate.

The NIEHS achieves its mission through multidisciplinary biomedical research programs, prevention and intervention efforts, and communication strategies that encompass training, education, technology transfer, and community outreach. NIEHS offers useful information on its work, including chemical safety, at http://www.niehs.nih.gov/.

National Institute of Environmental Health Sciences

MD B2-01

P.O. BOX 12233

RTP, NC 27709 Ph: (919)541-3201            (919)541-3201   

5.9 OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)

The mission of the Occupational Safety and Health Administration (OSHA) is 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 Occupational Safety and Health Act of 1970, as amended in 1990 (ref. Chapter 4)..

OSHA and its state partners have approximately 2100 inspectors, plus complaint discrimination investigators, engineers, physicians, educators, standards writers, and other technical and support personnel spread over more than 200 offices throughout the country. This staff establishes protective standards, enforces those standards, and reaches out to employers and employees through technical assistance and consultation programs.

Nearly every working man and woman in the nation comes under OSHA's jurisdiction (with some exceptions such as miners, transportation workers, many public employees, and the self-employed). Other users and recipients of OSHA services include: occupational safety and health professionals, the academic community, lawyers, journalists, and personnel of other government entities. OSHA is determined to use its limited resources effectively to stimulate management commitment and employee participation in comprehensive workplace safety and health 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.

OSHA offers information about its programs on Internet site: http://www.osha.gov/.

Office of Information and Consumer Affairs

Occupational Safety and Health Administration

U.S. Department of Labor

200 Constitution Avenue, NW, Room N3647

Washington, DC 20210

Phone: (202) 219-8151              (202) 219-8151; Fax: (202) 219-5986

5.10 NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH (NIOSH)

NIOSH was established by the Occupational Safety and Health Act of 1970 (ref. OSHA description above). NIOSH is part of the Centers for Disease Control and Prevention (CDC) and is the federal Institute responsible for conducting research and making recommendations for the prevention of work-related illnesses and injuries. The Institute's responsibilities include:

• Investigating potentially hazardous working conditions as requested by employers or employees;
• Evaluating hazards in the workplace, ranging from chemicals to machinery;
• Creating and disseminating methods for preventing disease, injury, and disability;
• Maintaining and updating the Registry of Toxic Effects of Chemical Substances;
• Conducting research and providing scientifically valid recommendations for protecting workers; and
• Providing education and training to individuals preparing for or actively working in the field of occupational safety and health.

Although NIOSH and OSHA were created by the same Act of Congress, they are two distinct agencies with separate responsibilities. OSHA is in the Department of Labor and is responsible for creating and enforcing workplace safety and health regulations. NIOSH is in the Department of Health and Human Services and is a research agency. NIOSH identifies the causes of work-related 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. The jurisdictional exceptions that apply to OSHA, such as miners, transportation, agriculture, and public employees, do not apply to NIOSH. NIOSH has integrated the former Bureau of Mines into its program to better serve the mining community. Creating new ways to prevent workplace hazards is the job of NIOSH. With today's economic, health care, and worker's compensation crises challenging our country, prevention is an approach whose time has come.

NIOSH offers information about its activities at Internet site: www.cdc.gov/niosh/homepage.html

NIOSH

200 Independence Ave., SW

Washington, DC 20201 Ph: (202) 401-6997             (202) 401-6997     

5.11 U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT (USAID)

USAID supports development assistance projects related to the sound management of chemicals as part of its sustainable development initiative. At the 1992 United Nations Conference on Environment and Development (UNCED), both rich and poor nations agreed that economic growth and environmental stewardship must both be pursued to avoid a catastrophic overload of the Earth's carrying capacity in the next century. Economic growth cannot be sustained if the natural resources that fuel that growth are irresponsibly depleted. Conversely, protection of the environment and careful stewardship of natural resources will not be possible where poverty is pervasive. This is the conundrum and the opportunity of sustainable development.

USAID has two strategic goals for sustainable development: (1) reducing long-term threats to the global environment, particularly loss of biodiversity and climate change; and (2) promoting sustainable economic growth locally, nationally, and regionally by addressing environmental, economic, and developmental practices that impede development and are unsustainable.

USAID is concentrating on the following kinds of problems:

• Globally, it will focus on the growing sources and diminishing sinks of greenhouse gas emissions and on impoverishment of the planet's biological diversity at the genetic, species, and ecosystem levels.
• Locally, it will focus on the abiding impairment of human health due to air, water, and soil contamination from industrial, agricultural, and household activity; unsustainable exploitation of forests, wetlands, coastal zones, coral reefs, and other ecosystems that provide vital ecological services; degradation and depletion of water resources; unsustainable agricultural practices; inefficient and environmentally unsound energy production and use; inadequate management of household and municipal wastes in growing urban areas; regulatory, statutory, enforcement, and policy issues; and social and economic patterns, including the lack of local participation and empowerment, that contribute to the aforementioned problems or impede solutions.

USAID will pursue an integrated approach to environmental issues as outlined in Agenda 21 of the UNCED (Earth Summit) guidelines for ecologically sustainable development. The causes of environmental degradation often are the result of underlying pressures of poverty and rapid population growth. Programs in every sphere of development -- environment, economic growth, population and health, democracy -- must be designed with conscious regard for their impact on the natural environment and their potential for improving environmental stewardship locally, nationally, regionally, and globally. USAID will strengthen its institutional capacity to ensure that all Agency-supported efforts, whether projects or program-related investments, are environmentally sound. Where necessary, it will require mitigating measures or project redesign.

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. As appropriate, USAID-supported programs will target objectives such as: (1) conservation of soil and water through improved tilling practices, erosion planning and control, integrated pest management, reductions in the use of pesticides and in fertilizer and pesticide runoff, efficient design and management of irrigation systems, and protection of aquifers and integrated water resource planning and management; (2) reduction of industrial- and energy-related environmental degradation through the adoption of pollution prevention strategies and pollution control systems in industry, and through energy efficiency programs, renewable energy applications, fuel switching, and installation of environmental controls in the energy sector; (3) amelioration of rural and urban natural resource management problems and land-use problems through efforts to limit deforestation and promote reforestation; support for conservation and environmentally sustainable uses of forests, coastal zones, and other important ecosystems; and in urban areas, improved water resources management, land-use, sewage and waste disposal, and transportation planning; and (4) strengthening public policies and institutions to protect the environment.

An example of USAID's sustainable development chemical safety activities is a cooperative agreement between USAID Office of Foreign Disaster Assistance and the World Environment Center (WEC) to establish a Local Accident Mitigation and Prevention Program (LAMP). LAMP will provide approximately $3.5 million from 1992 to 1997 to establish chemical emergency planning programs in India, Indonesia, Mexico and Thailand, building on successful elements of the Awareness and Preparedness for Emergencies at the Local Level (APELL) workshops initiated by UNEP. LAMP is designed to improve the capacity of local authorities and corporate managers to prevent or mitigate technological and industrial disasters in specific high risk areas. It helps increase awareness of man-made accidents, and improved response to technological (chemical) emergencies, reduce risk to persons and property caused by the threat of such emergencies, and improve local capabilities to respond to technological emergencies and natural disasters. The LAMP national projects are driven by industry and governments. Efforts are being made to expand the level of citizen involvement.

Another example of a USAID project that began with a specific focus on pesticides and has been expanded to cover broader environmental protection goals is the U.S. EPA/USAID Central American Project. This project is described in Section 9.2.

USAID offers information about its activities at Internet site: www.info.usaid.gov/environment/

USAID

State Department Building

320 21st Street, N.W.

Washington, DC 20523 Ph: (202) 647-9620              (202) 647-9620   

5.12 U.S. DEPARTMENT OF COMMERCE

The Chemicals, Pharmaceuticals, and Biotechnology Division of the U.S. Department of Commerce conducts in-depth analysis of the chemicals industry and identifies and promotes the development of domestic and international business opportunities. The Division provides industry analysis and statistical information, as well as business counseling and export assistance. The Division participates in domestic and foreign policy discussions (e.g., trade, environmental, legislative, and regulatory) affecting the U.S. chemicals industry.

Chemicals, Pharmaceuticals, and Biotechnology Division

U.S. Department of Commerce

Room 4053 Hoover Building

Washington, D.C. 20230 (Ph) 202-482-0128 (Fax) 202-482-2565

CHAPTER 6: INTERAGENCY COMMISSIONS AND COORDINATING MECHANISMS

6.1 OVERVIEW

There are a variety of coordinating mechanisms in place in the United States for chemical safety activities. This version of the profile provides only an overview of key coordinating mechansisms and some specific examples for the pesticides program area.

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 and other agencies, 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 and meetings with non-governmental organizations.

For example, preparations for IFCS and other international meetings normally include one or more pre-meetings of the Interagency Group on Chemicals, which includes representatives from all agencies whose scope covers some aspect of chemical safety management, research or information -- EPA, State Department, Department of Human Health Services (National Institute for Environmental Health Statistics (NIEHS), National Institute for Occupational Safety and Health (NIOSH), Agency for Toxic Substances and Disease Registry (ATSDR)), the Occupational Safety and Health Administration (OSHA), the Food and Drug Administration (FDA), Department of Transportation (DOT), Consumer Product Safety Commission (CPSC), U.S. Department of Agriculture (USDA), Department of Commerce, and the Agency for International Development (AID). The Office of the U.S. Trade Representative is included as needed. 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.

Although a complete listing of interagency and intersectoral chemical safety coordination mechanisms is beyond the scope of this version of the profile, the coordination of pesticide issues described in this section is illustrative of the process.

Pesticide and pest control issues often involve the jurisdiction of several federal agencies. To promote efficiency and consistency of Federal efforts, EPA's Office of Pesticide Programs (OPP) coordinates many of its activities with those agencies through Memoranda of Understanding and less formal working groups. Some of the areas of common activity are: FDA — food safety and antimicrobial pesticides (such as hospital disinfectants); USDA — food safety and farm-related regulations (such as worker protection and pesticide storage and disposal); Consumer Product Safety Commission — labeling issues; Department of Interior — endangered species; Occupational Safety and Health Administration — worker protection; Customs and Coast Guard — import and export issues; Department of Defense — pest control on military installations; and Department of Transportation — harmonization of safety standards for hazardous chemicals.

The Interagency Testing Committee (ITC) contains representatives from the above Federal agencies and others to identify research needs and coordinate efforts to test industrial chemicals and pesticides.

Another example of Federal coordination was the 1995 EPA/OPP interagency agreement with the U.S. Geological Survey (USGS). This agreement will allow OPP to access USGS monitoring data and information on water quality trends, thereby enhancing OPP's ability to assess ground and surface water vulnerability to pesticide contamination and to make sound regulatory decisions to protect water resources.

OPP played a significant role in the 1995 independent panel review of the National Agricultural Pesticide Impact Assessment Program (NAPIAP), a US Department of Agriculture program. Recognizing significant changes in the demands for information and in regulatory priorities, tight budgets, and government reinvention, the panel was charged with evaluating NAPIAP in the context of USDA's overall pesticide and pest management information function. The panel's report highlighted 13 key findings and recommendations. The report reaffirmed NAPIAP's primary mission to provide science-based benefits information that contributes to EPA's pesticide regulatory decisions. The report recommended improving benefits information by establishing formal procedures and assessment-specific protocols, and continuing to improve communications and cooperation between USDA and EPA. OPP is continuing to work with USDA to address these recommendations.

OPP is establishing in 1996 a broad-based stakeholders advisory committee with subcommittees addressing evolving issues. This forum will provide an opportunity to educate stakeholders and achieve EPA/stakeholder cooperation on important pesticide policy issues.

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.

Some states have pesticide regulatory and enforcement programs that may exceed Federal levels. For example, the State of California's Department of Pesticide Regulation (DPR) has state-level requirements to conduct independent assessments and registration of pesticide products. EPA and DPR are working closely together to harmonize their scientific assessment procedures and share the U.S. pesticide assessment workload. Due to the uniqueness of Cal/DPR's authorities and programs, they are descibed in more detail in Section 4.4.3.

CHAPTER 7: DATA ACCESS AND USE

7.1 OVERVIEW

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) 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 (ref. Section 4.4.4). 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 finding ways to make data and other information on chemical safety available through the Internet Web or online networks. For example:

EPA offers the ENVIROFACTS Master Chemical Integrator (EMCI) under the "Data Base" option on its Internet home page (www.epa.gov). EMCI is used to integrate, based on user search queries, the varied chemical identifications used in three program system components currently available in ENVIROFACTS. EMCI uses an internal identification system that is based on Chemical Abstract Service (CAS) numbers and names as a cross reference to link chemicals in three of EPA's major chemical data systems. EMCI provides a common means of identifying chemicals across program systems. The integrator eliminates the need for a user to know how the chemical substance of interest is identified in the various systems when accessing environmental data such as discharge limits, reported releases, etc. from different program office systems.

EPA's Integrated Risk Information System (IRIS), managed by EPA's Office of Research and Development, is intended for environmental health professionals who deal with risk issues on a regular basis. IRIS comprises summaries of health risk, and EPA regulatory information on over 500 specific chemicals are maintained. IRIS contains the EPA consensus opinion on potential chronic human health effects related to chemical hazard identification and dose-response assessment. Access to IRIS through NLM's TOXNET allows free text search capability, full Boolean logic, a powerful and flexible command language, and a variety of online user assistance features. IRIS was developed in response to a growing demand for consistent chemical substance risk information, representing Agency consensus opinions, for use in decisionmaking and regulatory activities. IRIS does not provide situational information on instances of exposure. It directs users to the underlying animal and human data on which this risk information is based. Because of the assumptions and uncertainties used in risk assessment, IRIS risk information should be used carefully and with scientific judgment.

The public can access IRIS through the National Library of Medicine's (NLM's) Toxicology Data Network (TOXNET) (Network Address: toxmail@tox.nlm.nih.gov). TOXNET fees are currently $18/hour. IRIS information can also be obtained by purchasing disks from the National Technical Information Service (NTIS) at 703-487-4650,  703-487-4650. Each NTIS update costs $140.00. EPA/state users access IRIS via IRIS2, a PC-based version of the data base.

The California Department of Pesticide Regulation (Cal DPR) is working closely with the EPA's Office of Pesticide Programs to develop Internet access to data sets that are of significant value to both organizations and the public. Brief registration information on approximately 89,000 products is currently online via the Cal DPR Internet site at www.cdpr.ca.gov. The data include: product number and name, company number and name, registration date, cancellation date and reason (if cancelled), and product manager name and phone number. In addition, OPP's databases containing chemical ingredient and firm information are now available through Cal DPR's site (www.cdpr.ca.gov). The chemical data is searchable by common, technical, synonym, CAS number, or trade names. The firm data is searchable by firm number, name, or portions thereof. These chemical, firm, and product databases have complementary links and are searchable by multiple variables. The current public access is on a trial basis and designed to generate public, agency, and industry feedback. The two agencies have also initiated cooperative efforts with Japan, which is building the Global Information Network on Chemicals, to investigate cross-searching of relational data bases on Internet.

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 agency-based 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. GILS systems are required by the U.S. Office of Management and Budget (OMB). The U.S. National Archives and Records Administration has issued guidance for Federal agencies concerning the data elements comprising GILS Core Records to ensure standard formats.

The U.S. Government Printing Office (GPO) offers a central access point to most Federal agency GILS systems at URL: www.access.gpo.gov/su_docs/. Because the Federal agency GILS systems are decentralized, GPO is attempting to provide a single point of entry to access, or link to, all U.S. Federal GILS databases. Not all agencies have mounted their GILS records on the GPO Access server and some are not easily accessible. Because not all agencies have provided information on location of their GILS records at this time, this cannot be considered a comprehensive database, but will become more comprehensive as more Federal agencies establish Internet sites and mount GILS systems. In developing its GILS application, GPO laid the groundwork for assisting other agencies in fulfilling their GILS responsibilities. A large number of agencies have mounted their GILS records on the GPO Access server. These agencies are listed individually in the scroll box located on the GILS search page. Agencies that have mounted their GILS records on a server other than GPO Access have been asked to provide a GILS pointer record, describing their GILS holdings and containing links to those holdings. Questions regarding GPO's GILS system may be directed to Internet Email address: gpoaccess@gpo.gov; telephone: 202-512-1530, 202-512-1530; or fax: 202-512-1262.

Providing a description of all Federal and other chemical safety data bases and information is beyond the scope of this profile. The GILS system may be used to learn more about the wealth of Federal data systems on chemical safety. For example, EPA's GILS system is accessible at Internet Web URL: www.epa.gov/gils/index.html. The EPA GILS site is searchable and provides links to pages with detailed information about each data base or other information system. A search of EPA's GILS for "chemical safety" brings up 39 links to pages with information on major EPA chemical data bases, including the Toxic Chemical Release Inventory System (TRIS), Toxic Substances Control Act Test Submissions (TSCATS), Computer-Aided Management of Emergency Operations, National Pesticide Information Retrieval System, Accidental Release Information System, Integrated Risk Information System, and the Pesticide Information Network.

CHAPTER 8: TECHNICAL INFRASTRUCTURE

8.1 GENERAL INFORMATION ON U.S. TECHNICAL INFRASTRUCTURE

The U.S. has invested heavily in public and private chemical safety laboratory and other research 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 and higher education facilities, conduct research on chemical safety issues. Federal agencies with research responsibilities are described in chapter 5 (ref. in particular EPA/ORD, NIOSH, NIEHS, CPSC, ATSDR, FDA, USDA). Scientists at public and private higher education institutions throughout the United States conduct extensive research on chemical safety and the sound management of chemicals. Private laboratory facilities develop the extensive data that pesticide registrants and other chemical industry sources are required to submit to EPA. The number and location of all U.S. laboratories and other research facilities are too extensive to include in this profile. As an illustration, the number of facilities tracked by EPA for compliance with FIFRA Good Laboratory Practice (GLP) standards are as follows:

GLP LABORATORY STATISTICS *

Discipline	Number of Facilities
Toxicology	724
Product Performance	303
Product Chemistry	465
Chemical Fate in Plants	225
Chemical Fate in Animals	152
Chemical Fate in the Environment	419
Field Sites	(276)
Analytical Laboratories	(143)
Residue Chemistry	752
Field Sites	(542)
Analytical Laboratories	(210)

* Source: EPA Office of Enforcement and Compliance Assurance. Note that the same lab may be counted in multiple categories if it develops GLP data for more than one scientific discipline.

The United States has an innovative Federal/State cooperative process to develop residue data for crops that are minor uses of pesticides. Pesticide registrants often lack economic incentives to support these minor uses on their product labels. Residue data is required to support the establishment of tolerances (maximum residue levels) or exemptions from the requirement for tolerances for a particular crop or crop grouping.

Inter-regional Research Project Number 4 (IR-4), jointly funded by the US Department of Agriculture and State Agricultural Experiment Stations, was established in 1963 to develop residue data for high priority minor uses. The IR-4 program has proven to be a very effective mechanism to support data development for pesticide registration for important minor uses, thereby overcoming a significant portion of the economic disincentives facing minor use registrants. USDA's IR-4 program identifies minor use needs and develops residue data based on an annual, national planning process that includes EPA participation and information on EPA review schedules and registrant intentions.

IR-4's primary objective is the development of data required by EPA to support tolerances and registration for new food uses for registered pesticides that are needed for the production of minor crops in the U.S. IR-4 has also provided data required to retain many important minor uses during EPA's reregistration review process for older pesticide that began in 1989 and is ongoing. IR-4 is also committed to aiding in the development and clearance of biologically-based alternatives for pest management on minor crops. The program has earmarked substantial additional funding for the purpose of enhancing the application of Integrated Pest Management (IPM) strategies, advancing the objectives of reducing pesticide residues, and providing a safe and wholesome food supply. IR-4 data development represents a long-term solution to minor use needs because it supplies EPA with data needed to establish or maintain tolerances.

USDA funds for IR-4 are highly leveraged with State resources through the Land Grant university system. Federal funding for IR-4 has increased in recent years - the FY 95 appropriated budget was $8.3 million compared to $2.8 million in FY 89.

IR-4 is working with EPA and Canada’s Pest Management Regulatory Agency (PMRA) to harmonize programs for expanding pesticide minor use registrations. Information on field residue studies conducted in Canada and the U.S. has been exchanged along with several pesticide data packages. Residue field trial maps are also being prepared which identify areas of similar climate and soil conditions for data development in Canada and the U.S. The field trial maps will allow residue data developed in specified areas to be used in support of tolerances in Canada and the U.S. IR-4 and Canada PMRA plan to coordinate future data development to harmonize and accelerate minor use registration in both countries.

CHAPTER 9: INTERNATIONAL LINKAGES

9.1 INVOLVEMENT WITH INTERNATIONAL ORGANIZATIONS, BODIES AND AGREEMENTS

The purpose of this chapter is to provide an overview of U.S. involvement in international activities and agreements and to allow all concerned parties to know who has the responsibility for contacts with the related international organizations.

Table 9.A: Membership in International Organizations, Programs and Bodies

Table 9.B: Participation in International Agreements/Procedures

Related to Chemicals Management

9.2 PARTICIPATION IN RELEVANT TECHNICAL ASSISTANCE PROJECTS

The U.S. participates in technical assistance projects world-wide related to chemicals safety. As an illustrative example, this section describes a Central American Project on pesticides, recently expanded to cover broader environmental protection issues, and an Indonesian pesticide project, both of which could serve as models for other regions of the world. See also Section 5.11 for general information about the U.S. Agency for International Development's sustainable development technical assistance projects.

Since 1992, the U.S. EPA and U.S. Agency for International Development (USAID) Central American project implemented by EPA's Office of Pesticide Programs has represented a major new direction in addressing environmental and natural resource issues facing developing countries. It has cut across jurisdictional lines to bring the expertise of multiple public and private sector agencies to bear on issues of common concern and develop approaches that enhance public health and environmental protection in Central America, while promoting compliance with U.S. food safety laws.

From the outset, the project has been mutually benefitted both the United States and Central America, helping to expand trade by providing U.S. importers with greater assurance that Central American fruits and vegetables destined for the United States will be free of violative pesticide residues. The focus on both trade and environmental issues has helped build stronger national and institutional support for the project.

While trade may have sparked initial interest, the U.S.'s experience in Central America illustrates ways to work with counterparts in developing countries to achieve broader public health and environmental goals. Already the lessons learned in Central America are being applied in other areas, including technical assistance to Mexico in pesticides, the evaluation of shrimp mortality and water quality problems in the Gulf of Guayaquil at the request of the Government of Ecuador, initiatives to expand pesticide information systems in Indonesia, and the preparation of two pesticide disposal guidance documents tailored to the needs of developing countries under the joint auspices of the UN Food and Agriculture Organization (FAO), World Health Organization (WHO) and UN Environment Programme (UNEP).

According to WHO, Central America has the highest per capita pesticide use in the world. The impacts on human health and the environment are significant in this part of the world. EPA and USAID negotiated an interagency agreement to address them. Major areas of collaboration under the agreement included: (1) strengthening regulatory institutions to help ensure improved control over the importation, distribution, use and disposal of pesticides; (2) promoting policies for safe pesticide use practices at all levels; and (3) supporting food export programs by providing information and technical assistance to help Central American countries meet U.S. import requirements. Key achievements of the project include:

• Technical assistance and educational workshops for regional regulatory officials and exporters, aimed at enhancing regulatory capabilities and compliance with U.S. laws. For example, translation and reproduction of a "manual for exporters."
• Upgrading regional pesticide laboratories, jointly EPA-FDA surveyed regional pesticide laboratory needs and capabilities. Development of regional workshops for laboratory personnel and the first-ever comprehensive laboratory training course and manual. Participants from five Central American countries attended the comprehensive training course given in cooperation with FDA in Dallas, Texas, in June 1995. This "train the trainers" technical cooperation should enhance pesticide regulation and control throughout the region.
• Training on pest management and safe pesticide use, collaboration with regional organizations in developing training materials for pesticide users and health professionals who may be faced with patients suffering from pesticide poisoning. Examples include review of course materials and participating in training conducted by the Pan American School of Agriculture (Zamorano, Honduras) and coordinating with the Institute of Nutrition for Central America and Panama (INCAP) on training materials for health professionals (arranging for the purchase and distribution of a Spanish translation of EPA's manual on the treatment and recognition of pesticide poisonings).
• Establishment of a regional resource center for pesticide information at Centro Agron๓mico Tropical de Investigaci๓n y Ense๑anza (CATIE) in Costa Rica, and continuing technical information support for regulatory authorities and pesticide users through a regional pesticide information network.
• Collaboration with other donor and international agencies working in the region (including FAO, the Pan American Health Organization, the German foreign aid agency (GTZ), the World Bank and others) on pesticide-related activities, such as the development of a combined inventory of safe pesticide use training materials, joint project implementation, and exchange of information on laboratory assessments.
• Successful implementation of a pilot pesticide disposal training activity, including the development of site-specific management options in El Salvador and training of local officials.

Overall, the EPA-USAID Central American project has formed an "essential alliance" that facilitates free information flow and appropriate technical assistance, helps ensure the safe importation of agricultural products into the United States, and allows Central Americans to make informed decisions as they continue to strive to improve their economies, sustain their natural resource base, and understand the importance of environmental protection.

In September 1995, USAID and EPA signed a participatory agency service agreement (PASA) for technical cooperation in support of regional efforts aimed at resolving environmental degradation problems in Central America. This PASA builds on accomplishments and effective partnerships developed by a successful pilot project on pesticides. It allows EPA the opportunity to continue a concentrated/coordinated effort in promoting environmental protection and sustainable development in Central America. More importantly, this PASA represents a key US initiative in response to the December 1994 Summit of the Americas, where leaders of the Western Hemisphere agreed on concrete actions to protect the environment and promote sustainable development. It also represents a key response to the 1994 CONCAUSA agreement which established a framework for technical cooperation between the United States and the Central American countries.

EPA will provide short- and long-term technical assistance and training support on environmental matters, and improved access to and exchange of environmental information. Our main clientele will be Central American entities involved in technical oversight in areas such as: (1) environmental laws and regulations, enforcement, and compliance; (2) monitoring environmental indicators for quality in soil, water, and air, and increased safety in toxic substances and waste management; (3) promotion of pollution prevention (economic incentives, cleaner technologies, alternatives); and (4) information dissemination mechanisms.

Cooperative efforts under the expanded agreement will be demand-driven, jointly consulted between the Central Americans, USAID, and EPA. Implementation of cooperative efforts will focus on: (1) the strengthening/building of institutional capabilities in Central America; (2) timely and appropriate responses to priority issues; (3) building of effective partnerships; (4) promotion of public participation; and (5) regionalization/coordination of efforts.

The goal of EPA’s Pesticide Technical Assistance Project with the Government of Indonesia (GOI) is to strengthen Indonesia's ability to regulate pesticides. At the same time, this project will improve EPA’s ability to provide pesticide information to other nations, using the Internet. It is likely that this project will also create the beginning of a regional pesticide information network in Southeast Asia, through cooperation with the Association of Southeast Asian Nations (ASEAN).

The Government of Indonesia, the U.N. Food and Agriculture Organization (FAO), the World Bank, and USAID have requested EPA’s participation in this project. Funds for this project are being provided by the Government of Indonesia through a loan from the World Bank. EPA's Office of Pesticide Programs will provide technical assistance in the following areas:

Information systems -- find appropriate sources of information, and develop capacity to store and retrieve data to support Indonesian regulatory program;

Registration and reregistration -- help develop analytical and procedural capacity for the review of pesticides;

Enforcement -- delivery of "Principles of Environmental Enforcement" training module;

Eliminating stocks of unwanted pesticides -- help plan for proper disposal and avoiding problems in future;

Legislation and regulation revision -- help plan for legislative and regulatory revisions needed to implement program improvements.

USAID’s Regional Agribusiness Project (RAP) will assist OPP in developing its capacity to publish information electronically. This will directly support the Indonesia project, as well as benefiting other countries who have an interest in the information that is published. The U.N. FAO, as well as AID staff in Jakarta, will support and advise EPA staff working in Indonesia. The Association of Southeast Asian Nations (ASEAN) is headquartered in Jakarta and will assist in expanding the impact of this project to the other six nations of that association.

This project can help to focus other international efforts aimed primarily at making pesticide and other chemical information accessible worldwide. For example, the Global Information Network on Chemicals (GINC), and ESCAP, an East Asian pesticide information system administered jointly by the European Union and the Government of Singapore have expressed an interest in working with EPA on this project.

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.

The U.S. has worked closely with international organizations (ref. Table 9.A) in the development of the international agreements/procedures (ref. Table 9.B). The U.S. is continuing to work through these fora to achieve improved chemical safety management world-wide. Important regional initiatives are described in this section.

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.

North America has taken an innovative stance on emissions inventories. The three countries that participate in the North American Free Trade Agreement (NAFTA) all will be able to track the releases and transfers of toxic industrial chemicals and pesticides from facilities. The U.S. was the first country to create a TRI. Canada now has a similar system. Mexico is developing an emissions inventory. Therefore, the opportunity will exist to aggregate the three countries' data. The U.S. and Canada have two ways of sharing emissions information. In the Great Lakes region, the two countries are obtaining information on releases and transfers from sites on both sides of the border. They will learn about the potential impacts of pollution on the lakes. The U.S. and Canada are also compiling data along their entire border. They will include information on the U.S.-Mexico border once the Mexican data base is ready. Recognizing the potential of sharing emissions information, the Commission on Environmental Cooperation (CEC), which was created under NAFTA to address environmental issues, is facilitating the further exchange of emissions data among the three countries. The CEC is assisting Mexico in completing the country's data base. The commission is also initiating dialogue among the three countries on ways to help potential users access the countries' data. One option is to include the three data bases on a single Internet homepage. Another choice is to aggregate the data for North America and make the resulting information available to the public.

The U.S. is working closely with Canada and Mexico through the NAFTA Technical Working Group on Pesticides to harmonize pesticide requirements and share the burden of work. By economic necessity and the shear volume of work to be done, the countries must develop more cost effective approaches to pesticide regulation. This can be achieved through harmonized requirements and sharing the burden of work. The NAFTA TWG work has already begun to pay dividends by promoting understanding of each country's procedures and requirements. In the very near future, the countries want to be in a position to share the workload of the reevaluation of old pesticides and develop a coordinated approach to the registration of new pesticides.

The Commission for Environmental Cooperation (CEC) was created to implement the environmental side agreement to NAFTA. CEC passed a 1995 resolution (Council Resolution 95-5) on the Sound Management of Chemicals. 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. Task Forces have been established for each chemical to prepare a Regional Action Plan for implementing risk reduction strategies. North America believes this effort will serve as a useful model for global action on persistent toxic chemicals.

The U.S. is also working with countries in the Americas region on chemical safety issues. EPA helped organize and participated in the first regional gathering of countries on chemical safety issues in November 1995 at the Expanded Americas Intersessional Group (ISG) meeting in Puerto Rico. The meeting established regional priorities and action plans in preparation for the March 1996 2nd IFCS/ISG (ISG-2) meeting in Canberra. Mexico hosted the meeting, which included fourteen countries and several international and non-governmental organizations. As a result, the Americas region was able to develop recommendations and issues and increase the usefulness of its regional breakout session at ISG-2.

CHAPTER 10: RESOURCES AVAILABLE FOR CHEMICALS MANAGEMENT

This chapter provides a fiscal year (FY) 1995 estimate of EPA's obligations for pesticides and industrial chemicals regulatory, enforcement, and research activities. 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 budgets but these resources were not compiled as part of this profile. The U.S. identifies resource needs and priorities as part of the annual budget process in the Administration and the Congress.

EPA Fiscal Year 1995 Obligations for Pesticides and Toxic Substances Programs

CHAPTER 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. It is beyond the scope of this profile to describe all of them. A number of NGOs were asked to provide brief summaries of their chemical safety activities for inclusion in this profile. The responding organizations are included in this chapter in alphabetical order. The listings in this chapter should be considered only as an illustration of the many strong and diverse U.S. NGO chemical safety organizations and programs.

 AMERICAN CROP PROTECTION ASSOCIATION

1156 Fifteenth Street, N.W.

Suite 400

Washington, D.C. 20005

(ph) 202-296-1585; (fax) 202-463-0474; Internet: www.acpa.org

Founded in 1933, the American Crop Protection Association is the not-for-profit trade organization of U.S. manufacturers, formulator and distributors of agricultural crop protection and pest control products. ACPA’s 83 member companies produce, sell and distribute virtually all of the active ingredients used in herbicides, insecticides, fungicides, rodenticides and similar products.

ACPA’s mission is to foster the interest of the general public and ACPA member companies by promoting the environmentally sound use of crop protection products for the economical production of safe, high quality, abundant food, fiber and other crops.

As a heavily regulated, scientific research and development-based industry, ACPA members are committed to the United Nations FAO Code of Conduct. Through GIFAP, the industry’s international association located in Brussels, ACPA member companies support pesticide education and training outreach programs in the developing world, with multi-year Safe Use Initiatives in Africa, Asia and South America. ACPA members are dedicated to the development of lower risk pesticides and to Integrated Pest Management.

AMERICAN FARM BUREAU FEDERATION

225 Touhy Avenue

Park Ridge, Illinois 60068

(ph) 312-399-5747 (fax) 312-399-5969 Email: scottr@fb.com

Internet URL: www.fb.com

600 Maryland Avenue, S.W. Suite 800

Washington, D.C. 20024

(ph) 202-484-3600 (fax) 202-484-3604

The American Farm Bureau Federation is the nation's largest general farm organization with over four million families in all 50 states and Puerto Rico. Farm Bureau is an independent, non-governmental, voluntary organization of farm and ranch families united for the purpose of analyzing the problems and formulating action to achieve educational improvement, economic opportunity and social advancement to promote the national well-being.

Farm Bureau recently developed a three part professional self-help education series entitled "Professionals From the Ground Up." The program is available to every county Farm Bureau and is designed to educate producers in the safe and wise use of agriculture chemicals and other technology. Farm Bureau has also distributed thousands of water quality self-help checklists. The checklist helps farmers analyze their water supply and to act voluntarily to reduce or prevent pollution on their farms.

Farm Bureau remains committed to ensuring that agricultural chemicals are used in a safe and judicious manner so as to protect the health and safety of producers, our families, our communities and the environment.

CHEMICAL MANUFACTURERS ASSOCIATION

1300 Wilson Boulevard

Arlington, VA 22209

(ph) 703-741-5000; (fax) 703-741-6000; Internet URL: (under construction)www.cmahq.com

The Chemical Manufacturers Association is a non-profit trade association whose approximately 200 member companies represent more than 90 percent of the productive capacity of basic industrial chemicals in the United States. Most of our members have international operations, frequently with facilities located in foreign countries. The chemical industry’s demonstrates its increasing commitment and ability to steward our products --from research, safe manufacture and distribution to use and disposal--through initiatives such as Responsible Careฎ.

Responsible Careฎ is designed to help the chemical industry improve its performance in the management of chemicals. As a condition of membership, companies sign a statement that says they will adhere to the Guiding Principles for Responsible Careฎ of chemicals. The initiative includes Codes of Management Practice in the areas of distribution, employee health and safety, community awareness and emergency response, process safety, pollution prevention and product Stewardship. Performance measures are being established for each Code. A Public Advisory Panel reviews the program and offers an independent evaluation of effectiveness.

The environmental accomplishments of the industry are best illustrated by reductions of emissions of substances under the Toxics Release Inventory. Between 1987 and 1993 such emissions by CMA members fell by 50 percent while output rose 18 percent. This period corresponds roughly with the life of Responsible Careฎ.

ENVIRONMENTAL DEFENSE FUND

1875 Connecticut Ave., NW Suite 1016 Washington, DC 20009

(ph) 202/387-3500; (fax) 202/234-6049; Internet URL: www.edf.org

The Environmental Defense Fund (EDF) is a nonprofit membership organization with more than 300,000 members in the U.S. With a staff of scientists, economists, and attorneys in six offices around the U.S., EDF works on a wide range of issues, including global climate change, preservation of aquatic and terrestrial biodiversity, sustainable international development, and pollution prevention.

EDF's activities on chemical safety occur primarily within the Environmental Health Program. Currently, the program is focusing on developing information-based strategies to enhance environmental health protection and on creating incentives to expand availability of, and access to, data on chemical toxicity and exposure. EDF is an active participant in OECD's Screening Information Data Set program, which has identified a basic information package needed to perform initial assessments of chemical safety and is now collecting data on specific high- volume chemicals. EDF has also been extensively involved in the OECD risk reduction strategy for lead, growing out of EDF's long- standing efforts to prevent exposure to lead and other toxic metals.

HAMPSHIRE RESEARCH INSTITUTE

1600 Cameron Street, Suite 100

Alexandria, Virginia 22314 (ph): 703/683-6695, 703/683-6695; (fax): 703/684-7704;

E-Mail: hampshire.org; Internet URL: www.hampshire.org

Role in Chemical Safety:

The Hampshire Research Institute HRI is a scientific, engineering, and computing resource on environmental chemicals issues. HRI is a non-advocacy organization and does not participate in litigation activity. The four main HRI program areas are--

Environmental Information: HRI encourages environmental improvement by defining information needs and data uses as well as by collecting, integrating, analyzing, and disseminating data about toxic chemicals in the environment, in industrial processes and waste, and in products. A major focus has been upon analyses of Pollutant Release and Transfer Registries (PRTR) in the U.S. and other countries, in creating Guidance documents for UNITAR and other organizations, and in supporting the needs of countries considering the development of a PRTR.

Pollution Prevention/Clean Technology: HRI analyzes the pollution prevention/clean technology actions of individual companies and industrial facilities. It also seeks to identify strategies to promote more pollution prevention in the future. With independent sponsorship HRI engineers have provided individual facilities with assessments of their pollution prevention opportunities (e.g. in Poland).

Development of Environmental Tools: HRI has developed four different public versions of RISK*ASSISTANT and RISK*ASSISTANT for Windows, which are powerful microcomputer-based chemical exposure and risk assessment tools. Similar tools are under development for workplace exposures and risks from chemicals. PRTR data analysis tools are also under development. HRI has also developed a prototype International PRTR World Wide Web Site for UNEP and is developing other Web sites.

Community Technical Support: HRI provides scientific and engineering support to community organizations in more than 15 different localities with local environmental chemical concerns.

PESTICIDE ACTION NETWORK NORTH AMERICA (PANNA)

116 New Montgomery, #810

San Francisco, CA 94105

Ph: (415) 541-9140, (415) 541-9140; Fax: (202) 293-9211 Email: panna@panna.org

Internet URL: www.panna.org/panna/

Pesticide Action Network North America (PANNA) is a nonprofit citizen-based NGO that advocates adoption of ecologically sound practices in place of pesticide use. PANNA works with over 100 affiliated organizations in North America, and with PAN partners around the world, to demand that development agencies and governments redirect support from pesticides to safe alternatives. PANNA believes that citizen action is essential to challenge global proliferation of pesticides, to defend basic rights to health and environmental quality, and to ensure the transition to a just and viable society.

PANNA's work on chemicals includes working with labor, environmental, women's, consumer and human rights groups worldwide to ensure that accurate information about chemical hazards and alternatives is available; participating in citizen campaigns to protect people and the environment from pesticides; and monitoring companies that produce and trade toxic agrichemicals.

SYNTHETIC ORGANIC CHEMICAL MANUFACTURERS ASSOCIATION

1100 New York Avenue, NW, Suite 1090

Washington, DC 20005

(ph) 202.414.412; (fax) 202.289.8584; Internet URL: www.socma.com

The chemical industry's Responsible Care initiative is designed to help companies respond to the public's concerns about environmental, health, and safety risks. Responsible Care is based upon a principle of continuous improvement and is built around the set of management practices and principles that SOCMA will fully incorporate as a condition of active membership. As the leading trade association representing the batch and custom chemical industry, SOCMA has received wide recognition for the steps it has taken to guide its membership in implementing Responsible Care. To assist its 168 active member companies in attaining these goals, SOCMA provides implementation assistance and has developed comprehensive resources to assist in running the program.

SOCMA is celebrating its 75th year representing the batch and custom chemical industry. This industry produces 95 percent of the 50,000 chemicals produced in the U.S. while making a $60 billion annual contribution to the economy. SOCMA's 270 member companies are representative of the industry and are typically small businesses with fewer than 50 employees and less than $50 million in annual sales.

WORLD WILDLIFE FUND

1250 24th St., NW

Washington, D.C. 20037

ph: (202) 293-4800, (202) 293-4800; fax: (202) 293-9211

World Wildlife Fund is a not for profit membership organization dedicated to conserving the wealth of life on Earth. Five strategies underlie its conservation work: creating and preserving protected areas, linking conservation and human needs, building capacity of public and private institutions, protecting species and reducing consumption and pollution.

WWF's work on chemicals issues includes science, policy analysis and advocacy. The Wildlife and Contaminants Project is synthesizing primary research and convening meetings of scientists to examine the impact of chemicals on the endocrine systems of wildlife and humans. The Pesticide Pollution Prevention Project develops and demonstrates policies that aim to reduce reliance on and risk from pesticides used in agriculture and for disease control.

WWF staff are bolstered by over 1.2 million members in the U.S. and project partners in 116 countries.

CHAPTER 12: INFORMATION SHARING FOR WORKERS AND THE PUBLIC

This chapter summarizes EPA activities to provide chemical safety information to the public and to workers exposed to pesticides. Information on other government information sharing programs is described under the relevant agency in Chapter 5. Information on NGO activities is described in Chapter 11. Chapter 7 on Data Access and Use also describes information sharing activities.

EPA gathers and evaluates large amounts of data on chemicals, prepares risk assessments and risk management decisions on these chemicals, and develops program proposals that have wide national and global impacts. Commensurate with this information gathering role, EPA has extensive outreach programs to inform the public about chemical safety activities and requirements and provide information on chemical risks. Many fact sheets and brochures are issued in both English and Spanish.

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.

EPA's 10 Regional Offices are OPPTS's primary connection to state, territorial, and tribal governments. They negotiate cooperative agreements for field programs, assist in developing and implementing programs, and oversee accomplishments and commitments made by the states, territories and tribes. Regional staff communicate OPPTS's programs and policies to the public and in turn provide OPPTS with public input.

OPPTS participate actively in the UNEP/FAO Prior Informed Consent (PIC) program and is participating actively in international efforts to make PIC legally binding.

EPA is committed to greater public accessibility of its data information systems through electronic dissemination. EPA pesticide and industrial chemical information resides on the Agency's Internet Web site (http://www.epa.gov, and particularly on subpage: http://www.epa.gov/internet/oppts). Information available at this site ranges from background on regulatory decisions to complete assessment documents. Services include:

• Electronic mailing lists, including lists of regulations, press releases, and "Monthly Hotline Report" questions and answers. Subscribers to the lists receive electronically mailed copies of the documents as they are published. Archives of the material are on the EPA Internet Web site.

• "Access EPA," has contact information and a description of services for EPA's major information resources, including clearinghouses and hotlines, databases, and EPA libraries. "Access EPA" is available through the EPA's Internet Web site under "EPA Information Locators."

EPA's Office of Pollution Prevention and Toxics (OPPT) 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.

EPA's authority under TSCA and nonregulatory approaches have been used to achieve these goals. OPPT:

• Sponsors conferences. TRI was the topic of a recent colloquium, which citizens and public interest groups attended.

• Prepares publications. Examples of available documents are "Chemicals-in-Progress Bulletin," "Pollution Prevention News," and "Reducing Lead Hazards When Remodeling Your Home."

• Is developing, in cooperation with the National Science Teachers Association, an education package for secondary-school children on TRI.

• Established or helped to create five centers to give technical assistance (see Part 2.2).

• Is carrying out a project that enables residents, businesses, and government officials of a polluted city to educate each other and work together to solve local problems.

• Provided a grant to a public interest group to work with communities greatly affected by one of the most polluted rivers in the U.S. The money is being used for creating an organization to implement a strategy to educate and involve the residents in cleaning the river.

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. The following five contacts are a major resource for the public:

• The TSCA Assistance Information Service, (202) 554-1404,   (202) 554-1404, responds to general questions and provides regulatory and nonregulatory material on TSCA.

• The Pollution Prevention Information Clearinghouse, (202) 260-1023, (202) 260-1023, and EPA's related Enviro$en$e electronic network (http://wastenot.inel.gov/Enviro$en$e/) provide a wide variety of information on pollution prevention, case studies, and technologies related to chemical management.

• The EPCRA Information Hotline, (703) 412-9877, (703) 412-9877, or 1-(800) 535-0202, 1-(800) 535-0202, replies to questions on EPCRA, has information on accessing the complete TRI data base, and forwards copies of EPCRA regulations and other items.

• The Asbestos Ombudsman Clearinghouse/Hotline, (703) 305-5938, (703) 305-5938, or 1-(800) 368-5888, 1-(800) 368-5888, answers questions and sends asbestos information. They also assist small businesses comply with all EPA regulations.

• The National Lead Information Center (NLIC): the NLIC Hotline, 1-(800) LEADFYI, 1-(800) LEADFYI, provides a basic packet of information on lead; the NLIC Clearinghouse, 1-(800) 424-LEAD, 1-(800) 424-LEAD, responds to questions and forwards material about lead.

• The TRI User Support Service, (202) 260-1531, (202) 260-1531, provides answers to general questions; referrals to State and EPA regional contacts, libraries, and other resource centers; support for access to TRI data; and documents on the inventory.

The information sources for the toxic substances provided by the Agency for Toxic Substances and Disease Registry (ATSDR) have been described in Chapter 4 (Section 4.5.1.2). Information on the availability of these documents is provided on a 24-hour Tox Information Hotline (404-639-6000, 404-639-6000). In addition, the Agency provides remote technical support during chemical emergencies with an emphasis on preventing adverse outcomes. This technical support is provided through an emergency response coordinator with assistance from a multi-disciplinary team of a toxicologist, chemist, physician, and health scientist. The ATSDR Emergency Response Section may be reached at 404-639-0615, 404-639-0615,.

The National Institute for Occupational Safety and Health (NIOSH) maintains a toll free number -- 800-35-NIOSH, 800-35-NIOSH, to provide information on chemical hazards encountered in the workplace. NIOSH also publishes the "NIOSH Pocket Guide to Chemical Hazards," which contains hazard information on over 700 substances.

Few organizations serve a wider "public" than EPA's Office of Pestcide Programs (OPP). Communications efforts must be tailored to the needs of a broad spectrum of constituents who are affected by or interested in OPP actions and policies: other EPA offices and regions, state and tribal agencies, individual citizens, environmental and public interest groups, industry and trade associations, pesticide users, health professionals, academia, foreign governments and international organizations, Congress and other federal agencies, and the media.

Appropriate outreach activities are vital to OPP'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 OPP's many "publics." To accomplish this, 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. This section describes some of the ways OPP provides information and obtains valuable public input.

In 1995, OPP issued approximately 65 announcements informing the public of major regulatory and policy decisions, continuing an upward trend from 1994. Each announcement is planned using a communications strategy, which often entails a press notice and additional outreach materials, such as fact sheets or questions and answers. In addition, OPP issued background materials to respond to inquiries arising out of media reports on pesticide-related issues. Public demand for pesticides information increased dramatically in 1995. Directly and through the National Center for Environmental Publications and Information, OPP managed distribution of over 700,000 copies of publications, a four-fold increase over FY 1994.

OPP is working with others inside and outside EPA to increase public awareness of available information resources on pesticides and ensure the most cost-effective, timely distribution of educational materials. One key accomplishment in FY 1995 was the production of an updated catalogue of pesticide publications. The catalogue was distributed in "hard copy" in 1995; it will be posted electronically and updated annually in the future.

Significant new publications developed in 1995 include joint publication with the Occupational Safety and Health Administration of a Guide to Heat Stress for Agricultural Workers and a major update and expansion of OPP's core consumer publication, Citizen's Guide to Pest Control and Pesticide Safety, to be printed and distributed in 1996.

Protecting children from pesticide poisoning continues to be an important focus of outreach efforts. In collaboration with the Poison Prevention Council and the Consumer Product Safety Commission, OPP participated in Poison Prevention Week and other activities, distributing thousands of copies of fact sheets to medical establishments and the general public. Fact sheet topics included child safety and using insect repellents safely (both in English and Spanish).

OPP responds to technical or complicated requests for information from the public under the Freedom of Information Act (FOIA). OPP continues to receive the highest number of FOIA requests of any program within EPA (1,537 requests in 1995 and 1,235 responses completed). The majority of requestors receive all of the records requested, with the most common requests being for science reviews of registration data, administrative files for pesticide products, and reregistration information.

OPP has established four dockets to house the regulatory notices, background documents, and public comments on OPP activities. These consist of the Federal Register, Special Review, Registration Standard, and Special Program Dockets. The docket now has the capability to accept the electronic submission of public comments. The most active docket action was the Triazines Special Review, which received over 87,000 public comments. Over 2,000 requests for docket information received by letter, telephone, and in person were filled in fiscal year 1995.

The National Pesticides Telecommunications Network (NPTN) is a national service accessible by a toll-free telephone number (1-800-858-7378 ,  1-800-858-7378) that provides objective information about pesticides upon request to anyone in the United States, Puerto Rico, and the Virgin Islands. NPTN provided services to more than 17,000 callers during fiscal year 1995, including approximately 1,700 calls concerning pesticide incidents. The remaining calls were requests for general information on pesticide products and issues concerning health, safety, and use.

The National Pesticide Medical Monitoring Program (NPMMP), located at Oregon State University, provides information and referrals on clinical toxicology questions and analytical services for biological and environmental samples. Health care professionals and possible victims of pesticide poisonings are major users of the service. NPMMP handled 452 incidents in FY 1995.

OPP receives many Letters and Inquiries due to rising public interest in pesticides and their effects on people and the environment. In 1995, OPP prepared responses for senior EPA officials to over 1,600 letters. Over 450 of the letters were responses to Congressional inquiries. In addition, OPP prepared testimony and briefing materials for four Congressional hearings on pesticide issues and activities, including implementation of the Worker Protection Standard and proposals for major changes in legislation governing pesticide regulation and food safety.

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.

Export Notification for Unregistered Pesticides: For all exports of pesticides not registered in the U.S., FIFRA section 17(a) requires the U.S. exporter to obtain a statement from the buyer acknowledging that the product is not registered. The exporter must submit this statement to OPP, and OPP forwards a copy to the importing government.

Information Exchange with Foreign Countries: FIFRA section 17(b) requires OPP to share information with health and environmental agencies in other countries. Under this requirement, OPP sends notices to other governments on important U.S. regulatory decisions. Notifications are distributed directly to pesticide regulatory authorities in approximately 140 countries.

OPP's Worker Protection Standard (WPS) for agricultural pesticides became fully effective in 1995. The Standard represents a major strengthening of national efforts to safeguard agricultural workers. It requires agricultural employers to ensure that employees receive basic training in pesticide safety and to notify workers when pesticides are applied. Employers also must provide washing facilities and supplies if workers are likely to come into contact with pesticides, and provide and maintain protective equipment to reduce potential health risks due to pesticide exposure in agriculture. OPP believes that effective implementation of the WPS will substantially reduce the risk of pesticide poisonings among agricultural workers and pesticide handlers. Implementation involves an extensive outreach effort.

In 1995, OPP carried out a number of WPS activities in collaboration with EPA's ten regional offices. In addition, OPP continued to refine requirements to maximize effective protection for workers in a wide variety of agricultural settings, while ensuring appropriate flexibility in implementation. Highlights of OPP's 1995 efforts include:

Ongoing work with pesticide registrants to ensure that the labeling of all agricultural pesticides was revised to convey stronger worker protection requirements, such as restrictions on entry into treated areas and use of personal protective equipment. The goal of ensuring that all end-users received the required WPS labeling by October 1995 was achieved, without creating undue burdens on the pesticide industry.

Work with the states, USDA's Cooperative Extension Service, and the agricultural community to help employers obtain the information and assistance they need. OPP created or funded 1,100,000 grower compliance manuals, 2,700,000 safety training manuals, 685,000 safety posters, 11,500 safety training videos, and 6,000 grower compliance video/slide sets that were made available free or at low cost to farmers and farmworkers.

Implementation of a voluntary program to issue training verification cards to agricultural workers and pesticide handlers upon completion of WPS training. This will promote safety training and help agricultural employers fulfill their responsibilities by making it easier for them to verify that their workers have been trained. To date, 2,500,000 training verification cards have been distributed to the 42 states, Puerto Rico, and two tribes participating in the program.

Workshops, periodic meetings, and ongoing discussions with agricultural groups and farmworker organizations affected by the WPS. These discussions enabled OPP to identify key concerns, resolve problems and improve implementation.

Appendix A: Contact Points

The lead for coordinating/drafting the U.S. National Profile on Management of Chemicals was:

Kennan Garvey

Policy and Special Projects Staff

Office of Pesticide Programs/OPPTS (7501C)

401 M Street S.W.

Washington, D.C. 20460

Ph: (703) 305-7106, (703) 305-7106

Fax: (703) 305-6244

Internet: garvey.kennan@epamail.epa.gov

Other signficant contributors were:

EPA Office of Pollution Prevention and Toxics

Diane Beal, EPA Office of Pollution Prevention and Toxics, (ph) 202-260-1822, 202-260-1822

Email: beal.diane@epamail.epa.gov

Lisa Faeth, EPA Office of Pollution Prevention and Toxics, (ph) 202-260-1817, 202-260-1817

Agency for Toxic Substances and Disease Registry

Dr. James S. Holler, Ph.D.

Agency for Toxic Substances and Disease Registry, Public Health Service

Department of Health and Human Services

Atlanta, Georgia 30333

Consumer Product Safety Commission

Kailash Gupta, Health Science Directorate, Consumer Product Safety Commission

4330 East West Highway, Bethesda, MD 20814 301 504-0994 x1386

Department of Commerce

Kim Copperthite, US Department of Commerce

Office of Chemicals & Allied Products (ph): 202 482-5124, 202 482-5124; fax: 202 482-2565

Department of Transportation

Frits Wybenga, International Standards Coordinator for Hazardous Materials Safety,

Office of Hazardous Materials Safety, Research and Special Programs Administration

Department of Transportation (ph) 202-366-0656, 202-366-0656    

National Institute for Occupational Safety and Health

Dr. Paul A. Schulte, Ph.D.

Director, Education and Information Division

National Institute for Occupational Safety and Health

Robert A. Taft Laboratories

4676 Columbia Parkway

Cincinnati, Ohio 45226-1998

Occupational Safety and Health Administration

Jennifer Silk, Health Standards Programs, Occupational Safety and Health Administration

U.S. Department of Labor, 200 Constitution Avenue, NW, Room N3718 Washington, DC 20210

Phone: (202) 219-7174, (202) 219-7174; Fax: (202) 219-7125; E-mail: jsilk@dol.gov 

See Chapter 5 for a complete list of agency addresses and other contact information.

Non-governmental organization addresses are listed in Chapter 11.