United States Environmental Protection Agency Office of Toxic Substances (TS-792) Washington DC 20460 July 1984 EPA 560/1-83-002 f/EPA The Toxic Substances Control Act ------- The Toxic Substances Control Act U.S. Environs r.r.j [...', :?!] Agency Region V, Lif?--. - 230 Sout1-, D. - • Chicago, lll;no;3 .. :;-..:. ------- Contents Introduction 1 Scope of the Law 2 Testing of Chemicals 2 Premanufacture and Significant New Use Notifications 3 Control of Hazardous Chemicals 4 Recordkeeping and Reporting 6 Relationship to Other Federal Laws 7 Research, Monitoring, and Data Systems 9 Exports and Imports 9 Disclosure of Data 10 Effect on State Laws 10 State Programs 10 Judicial Review 11 Actions by Citizens 11 Employee Protection 11 Civil and Criminal Penalties 12 Enforcement 12 TSCA Assistance Office 12 Further Information 13 EPA Regional Offices 13 U.S. Environment-' ---^.-"i .ftr-ncy ------- Introduction Chemicals —those found in nature and those created in labora- tories — are at the heart of our highly indus- trialized, technology- based society. They help to protect our health and to control pests. Chemi- cals help clothe, shelter, and feed us. They are found in innumerable products for our homes, businesses, and industry. The chemical industry plays a vital role in the economy of the United States. The production of chemicals and allied pro- ducts accounted for roughly 5 percent of the Gross National Product, and the in- dustry employs about 1.1 million people. More than 60,000 chemical substances are presently manufactured or processed for commercial use in the United States, and almost one thousand more are introduced each year. Although most chemicals present little or no danger to the environment or human health when used properly, in the past few decades some chemicals commonly used and widely dispersed have been found to be significantly harmful. An example is the family of chemicals called polychlorinated biphenyls, or PCBs It was not until after tens of millions of pounds of PCBs were produced and released into the environ- ment, however, that scientists realized how persistent and potentially toxic they were. Over the past few years, we have found PCBs in our bodies and even in the milk of nursing mothers. In 1971, the President's Council on En- vironmental Quality developed a legisla- tive proposal for coping with the increas- ing problems of toxic substances. After five years of public hearings and debate, Congress enacted the Toxic Substances Control Act (TSCA) in the fall of 1976. By enacting TSCA, Congress established a number of new requirements and au- thorities for identifying and controlling toxic chemical hazards to human health and the environment. Programs now exist under TSCA to gather information about the toxicity of particular chemicals and the extent to which people and the environ- ment are exposed to them, to assess whether they cause unreasonable risks to humans and the environment, and to insti- tute appropriate control actions after weighing their potential risks against their benefits to the Nation's economic and so- cial well-being. The following sections briefly describe the major provisions of TSCA. The discussion is intended to familiarize the public with the provisions of the law, not to constitute an authoritative legal statement of it. ------- Scope of the Law To ensure wise and informed decision- making by the government, TSCA gives the Environmental Protection Agency (EPA) authority to gather certain kinds of basic information on chemical risks from those who manufacture and process chemicals. The law also enables EPA to require companies to test selected existing chemicals for toxic effects, and requires the Agency to review most new chemicals before they are manufactured. To prevent unreasonable risks, EPA may select from a broad range of control actions under TSCA, from requiring hazard-warning labels to outright bans on the manufac- ture or use of especially hazardous chemicals. EPA may regulate a chemical's unreasonable risks at any stage in its life- cycle: the manufacturing, processing, distribution in commerce, use, or disposal. Eight product categories are exempt from TSCA's regulatory authorities: pesticides, tobacco, nuclear material, firearms and ammunition, food, food additives, drugs, and cosmetics. Many of these product categories are regulated under other Fed- eral laws. Testing of Chemicals TSCA gives EPA authority to require manufacturers or processors of certain ex- isting chemicals (i.e., those already being distributed in commerce) to test their health and environmental effects. EPA ex- ercises this authority only when it can make certain statutory findings about the substance involved and when industry fails to develop the needed data on its own. These required findings are: (1) that there are insufficient data already available with which to perform a reasonable risk assessment; (2) that testing is necessary to provide such data; (3) that a chemical may present an unreasonable risk of injury to human health or the environment; or (4) that the chemical is produced in sub- stantial quantities resulting in significant human exposure or environmental release. Testing requirements are imposed only after a rulemaking proceeding which in- cludes opportunities for both public com- ments and an oral presentation at a hearing. An Interagency Testing Committee of gov- ernment experts on chennieal substances advises EPA on those that should be tested; however, actions are not limited to those recommended by the Committee. The eight Committee members represent the Departments of Labor, Commerce, Health and Human Services (including the National Cancer Institute, the National In- stitute for Occupational Safety and Health, and the National Institute of Environmental Health Sciences), the National Science Foundation, the Council on Environmental Quality, and EPA. The Committee desig- nates priority chemicals for testing. Then, EPA either initiates rulemaking for testing requirements for designated chemicals or publishes the reasons why testing is not required. ------- Premanufacture and Significant New Use Notifications The authors of TSCA recognized that health and environmental considerations . are more easily addressed before, rather than after, a chemical is produced and in- troduced into commerce. Thus, manufacturers or importers of new chemicals must give EPA a 90-day advance notification of their intent to manufacture or import a new chemical, except for those chemical categories specifically excluded by TSCA. Any chemical which is not listed on the inventory of existing chemicals (discussed in "Recordkeeping and Report- ing" section), published by the Agency, is considered "new" for purposes of this premanufacture notice requirement. In addition, EPA may designate a use of a chemical as a significant new use, based on consideration of several factors, includ- ing the anticipated extent and type of ex- posure to human beings or the environ- ment. Anyone who intends to manufac- ------- ture, import, or process a chemical for such a significant new use (even if the chemical is on the inventory and/or went through premanufacture notification re- view) must notify EPA 90 days before manufacturing, importing or processing the chemical for that use. The 90-day review period for new chemi- cals and significant new uses can be ex- tended by EPA for an additional 90 days for a good cause. Notices submitted for new chemicals, or significant new uses of chemicals, are to include: the identity of the chemical, its molecular structure, pro- posed categories of use, an estimate of the amount to be manufactured, imported or processed, the byproducts resulting from the manufacture, processing, use, and dis- posal of the chemical, estimates of expo- sure and any test data related to the health and environmental effects of the chemical. In addition, if a rule requiring testing of the chemical or its chemical class has been issued, the notice must include test data developed from that testing along with the other information. Chemicals produced in small quantities solely for experimental or research and development purposes are automatically exempt from the premanufacture and sig- nificant new use notification requirements. In addition, any person may apply for an exemption for chemicals used solely for test marketing purposes or those deter- mined by EPA not to present an unreason- able risk of injury to human health or the environment. If EPA determines that insufficient informa- tion is in a notification to evaluate potential risk, the Agency may order that the manu- facture or importation of the chemical be prohibited until adequate data are devel- oped. The company is under no time limit to submit the information, but until it does, EPA's ban remains in effect. After review- ing a premanufacture notification, contain- ing sufficient data, if EPA determines that the new chemical presents or will present an unreasonable risk of injury to health or the environment, the Agency can during the review period prohibit the manufactur- ing, processing, or distribution in com- merce of that chemical. Control of Hazardous Chemicals Under TSCA, EPA has the authority to prohibit or limit the manufacture, import, processing, distribution in commerce, use, or disposal* of a chemical when these ac- tivities are found to pose an unreasonable risk of injury to human health or the en- vironment. A number of possible control options are available, ranging from total prohibition to labeling. 'Distinction Between Disposal Authority of TSCA &RCRA: TSCA has the authority to regu- late the disposal stage of a chemical's life cycle on a chemical-by-chemical basis, that is, once a particular chemical is determined to be an un- reasonable risk to human health and the envi- ronment (e.g., PCBs). The Resource Conserva- tion and Recovery Act (RCRA) has the authority to establish regulations and programs to en- sure safe waste treatment and disposal of any number of chemicals, and generally deals with waste streams rather than individual chemicals. ------- A manufacturer or processor may be re- quired to make and keep records of the processes used in manufacturing a chemi- cal and to conduct tests to assure com- pliance with any regulatory requirements. Further, the Agency may require a manu- facturer or processor to give notice of any unreasonable risk of injury presented by his chemical to those who purchase or may be exposed to that substance. A manufacturer or processor may also be required to recall a substance which pre- sents an unreasonable risk. In proposing regulatory actions, EPA must provide an opportunity for comments by all interested parties. A rule limiting, but not banning, a chemical may be made immediately effective when initially proposed in the Federal Register if the Agency determines that the chemical is likely to present an unreasonable risk of serious or widespread injury to health or the environment before normal rulemak- ing procedures could be completed. In the case of a rule prohibiting the manufacture of the chemical, EPA must first obtain a court injunction before the rule can be made immediately effective. For those chemicals that present an immi- nent and unreasonable risk of serious or widespread injury to health or the envi- ronment, EPA may ask a court to require whatever action may be necessary to pro- tect against such risk. (EPA also cooperates with other agencies in toxic chemical control. See Relationship to Other Laws, page 7.) In addition to using various control op- tions, EPA warns the public about chem- ical hazards through its chemical advisory program. Chemical advisories encourage individuals or organizations to voluntarily reduce the risks associated with a chem- ical, such as the risk of continual contact with used motor oil. Chemical advisories discuss toxic effects of chemicals of con- cern, routes of exposure, and alternative methods of reducing risks. Polychlorinated Biphenyls (PCBs). In TSCA, Congress singled out PCBs for both immediate regulation and phased with- drawal from the market. EPA may au- thorize certain uses of PCBs and may exempt, pursuant to certain TSCA criteria, specific activities involving the manufactur- ONTAI ------- ing, processing, or distribution in com- merce of PCBs. PCBs are of concern be- cause tests on laboratory animals show that chronic exposure to PCBs may cause reproductive failures, gastric disorders, skin lesions, and tumors. Moreover, PCBs persist and when released into the envi- ronment tend to accumulate in tissues of living organisms. This means that, as PCBs move up in the food chain toward hu- mans, their concentration, and thus their potential for harm, increases. Recordkeeping and Reporting A major challenge for the TSCA program was to develop a mechanism for identi- fying those chemicals likely to damage human health or the environment so that appropriate action could be taken by in- dustry or EPA. In fact, Congress recognized during its discussion on TSCA that very little was known about chemicals in the environment. When the law was passed, it was not even known how many chemicals there were, in what quantities they were produced and where, what their byproducts were, who was exposed to them and under what conditions. This information was available only for a handful of existing chemicals. Therefore, Congress gave EPA the author- ity to compile an inventory of existing chemical substances, and to develop additional information on these basic questions. The first inventory was published in 1979, based on information reported to EPA by chemical manufacturers, importers, and processors. The inventory— to which new chemicals are added when they go into production — shows now that nearly 58,000 commercial chemical substances are, or have been, manufactured or im- ported into the United States since Janu- ary 1,1975. (There are well over 5 million known chemical compounds, but most are research and development chemicals that are not used commercially.) It is important to note that the chemical inventory is not a list of toxic or hazardous chemicals. Rather, it lists existing chemi- cals by their specific chemical name (e.g., acetonitrile, bromobenzene, chlor- methane, etc.), giving for the first time an overall picture of the chemicals used for commercial purposes in 1he United States. In addition to being unprecedented, this list is of major importance because chemi- cals not on the inventory must be re- viewed by EPA under the premanufacture notification program before they are al- lowed into U.S. commerce. In addition to compiling the inventory, EPA has used its TSCA reporting authority to obtain produc- tion, use, release, and exposure data on a number of chemicals — including asbestos and chemicals recommended by the In- teragency Testing Commitlee for test rule consideration. TSCA also requires any person who manu- factures, processes, or distributes in com- merce any chemical substance or mixture to keep records of significant adverse reac- ------- tions to health or the environment that al- legedly were caused by the chemical. Rec- ords concerning health effects on em- ployees must be kept for 30 years; other records must be retained for 5 years. The Agency may require the submission of health and safety studies which are known or available to those who manufac- ture, process, or distribute in commerce specified chemicals. In addition, if the chemical industry has information which indicates that a chemi- cal presents a substantial risk of injury to health or the environment, EPA must be notified. Substantial-risk reporting has heightened industry's awareness of poten- tial chemical risks, often resulting in manu- facturers, processors, and distributors tak- ing action on their own to minimize expo- sure to hazardous substances. Relationship to Other Federal Laws TSCA explicitly requires EPA to coor- dinate its activities with those of other Federal programs involved in toxic chemical control administered by organizations such as: The Consumer Pro- duct Safety Commission, The Food and Drug Administration, The Department of Agriculture, The Occupational Safety and Health Administration, The Department of Transportation, The Department of Health and Human Services, and others. EPA may determine that an unreasonable risk presented by a chemical may be pre- vented or sufficiently reduced by action under a Federal law it does not administer. If so, a request to the agency administering the other law is made to determine whether the risk exists and if the other agency's action would sufficiently reduce the risk. If the agency finds no risk or takes action directed to the risk, EPA may then not take any regulatory action directed to that same risk. TSCA also directs EPA to use other laws it administers —such as the Resource Con- servation and Recovery Act or the Clean Water Act —to protect against unreason- able risks unless a determination is made that it is in the public interest to protect against such risks under TSCA. The following major laws are administered by EPA. • Clean Water Act, as amended, is the basic authority for water pollution control programs. The goal of the act is to make national waters fishable and swimmable. • Safe Drinking Water Act, as amended in 1977, permits EPA to regulate the quality of water in public drinking water systems and the disposal of wastes into injection wells. • Resource Conservation and Recovery Act of 1976 ("RCRA") authorizes EPA to establish regulations and programs to ensure safe waste treatment and disposal. • Federal Insecticide, Fungicide, and Rodenticide Act ("FIFRA"), as amended, directs EPA to regulate the manufacture, distribution and use of pesticides and con- ------- duct research into their health and en- vironmental effects. • Toxic Substances Control Act of 1976 ("TSCA"), provides authority to regulate the manufacture, distribution and use of chemical substances. • Clean Air Act, as amended in 1977, pro- vides the basic legal authority for the na- tion's air pollution control programs, and is designed to enhance the quality of air resources. • Comprehensive Environmental Re- sponse Compensation and Liability Act of 1980 ("Superfund") establishes a pro- gram to deal with release of hazardous substances in spills and from inactive and abandoned disposal sites. • Marine Protection, Research, and Sanctuaries Act of 1972 permits EPA to protect the oceans from the indiscriminate dumping of waste. ------- Research, Monitoring, and Data Systems In order to fully meet statutory re- quirements, EPA and other Federal agen- cies have expanded research and related activities. The EPA Research Committee system has been established to serve as a cornerstone for program planning in the Office of Research and Development (ORD) and to effect a formal liaison between ORD and the other program offices within EPA. The Chemical Testing and Assessment Research Committee (CTARC) plans re- search activities relevant to TSCA. In addition to establishing a data system within EPA for information submitted under TSCA, the Agency is designing and establishing a system for toxicological and other scientific data accessible to all Federal agencies. EPA has developed the Chemicals-in- Commerce Information System (COS) to store and retrieve TSCA data. This system contains TSCA confidential business in- formation and state-of-the-art computer security techniques-. The computerized TSCA Inventory became operational in late 1979, and several information services have derived from it, including subsys- tems for Freedom of Information Act re- quests, inventory profiles for EPA Regional Offices, support for the TSCA premanufac- ture review process, and health and safety study submissions. The Interagency Toxic Substances Data Committee (ITSDC), formed in February 1978 by EPA and the Council on Environ- mental Quality, is continuing its work to construct a comprehensive Chemical Sub- stances Information Network (CSIN). CSIN enables toxic substances information users to have access to a number of inde- pendent and autonomous data banks in the public and private sectors. Users can make use of one computer to manage the logging-in, accessing, and processing of their queries for relevant records in and among many data and information sys- tems — one simple access point to a "library of systems." Through the ITSDC, EPA is responsible for the day-to-day administration of CSIN, which became operational in November of 1981. CSIN significantly advances the availability of chemical data to both gov- ernmental and private sector organizations to efficiently resolve and manage issues concerning chemical substances. Exports and Imports If a person intends to export a chemical which is subject 'to certain requirements under TSCA, he must notify EPA. The Agency is responsible for notifying the im- porting country's government of the ex- port and of EPA's regulatory action or the availability of information. With respect to imports, no chemical sub- stance, mixture, or article containing a chemical substance or mixture will be al- ------- lowed into the customs territory of the United States if it fails to comply with any TSCA rule or otherwise violates TSCA. TSCA requirements generally relate to substances that are produced and distributed in U.S. commerce. However, chemical substances produced in the United States but for export only, can be covered by TSCA if EPA finds that the chemical substance will present an unreasonable risk within the U.S. EPA may require that the chemical substance be tested, and may further regulate it. Disclosure of Data Confidential data, such as trade secrets and privileged financial data, will be pro- tected from disclosure by EPA. All health and safety information, submitted under TSCA, on chemicals in commerce is sub- ject to disclosure. A person submitting other types of data to EPA may designate any part of them as confidential. EPA will treat such information as confidential until the Agency determines that the informa- tion is not entitled to such protection. If the release of confidential business infor- mation is essential for the protection of health or the environment, EPA may dis- close it after notifying the person who submitted the data in advance of any con- templated release. Effect on State Laws With certain exceptions, TSCA will not affect the authority of any State or political subdivision to establish regulations con- cerning chemicals. If EPA issues a testing requirement for a chemical, a State may not establish a similar one for the same purposes. If EPA restricts the manu- facture or otherwise regulates a chemical under TSCA, a State may only issue re- quirements which are identical, are man- dated by other Federal laws, or prohibit the use of the chemical. In response to a re- quest by a State, EPA may grant an exemption to allow the State to regulate differently from TSCA regulatory actions under certain conditions. Specifically, EPA can grant exemptions if the State require- ment (1) would not cause a person or activ- ity to be in violation of a requirement under TSCA and (2) would provide a greater degree of protection and not un- duly burden interstate commerce. EPA is actively committed to a policy of delegating more authority and decision- making power to the States to implement TSCA. State Programs TSCA authorizes grants to be awarded to States to help establish programs to pre- vent or eliminate unreasonable risks as- sociated with toxic substances. Seven States and Puerto Rico were recipients of such grants in 1979, 1980, and 1981. The projects funded, which will be completed and evaluated in 1983 and 1984, ranged in scope from developing toxic substances data bases to establishing State strategies to investigate and, if necessary, control unreasonable risks. In addition, a Regional and State Relations Program to promote cooperative ap- 10 ------- preaches to dealing with toxic substances problems was begun. The program's de- sign and initial efforts came from recom- mendations made in a 1981 report submit- ted by the National Governors' Association (NGA), which studied, with the help of an EPA grant, how States manage toxics problems. Subsequently, grants to NGA were awarded to coordinate the States' ac- cess to EPA's Chemical Substances Infor- mation Network (CSIN), to act as a clear- inghouse to publicize State toxic sub- stances management practices and to allow experts from one State to advise their counterparts in another. In addition, a conference attended by twenty-six State representatives was held. During the 1982 State legislative sessions, issues concerning integrated toxics man- agement were monitored and a report on trends was issued. The toxics manage- ment activities were reviewed and as- sessed yielding profiles of eighteen States' programs from which needs analyses are being drawn. These activities and others will further de- velop EPA's cooperative relationship with States and an integrated approach to deal- ing with toxic substances. Judicial Review Not later than sixty days after a rule is promulgated under certain TSCA pro- visions, a person may file a petition for judicial review of such rule with the U.S. Court of Appeals for the District of Col- umbia Circuit or with the U.S. Court of Appeals for the circuit of his residence or business. Actions by Citizens Any person may bring a civil suit to restrain a violation of TSCA by any party or to compel the Agency to perform any nondiscretionary duty required by this law. In addition, any person may petition EPA to issue, amend, or repeal a rule under the testing, reporting, or restriction sections of TSCA. The Agency has 90 days to respond to a petition. If no action is taken or a petition is denied, the party has the op- portunity for judicial review in a U.S. District Court. In both civil suits and citizens' petitions, the court may award reasonable legal costs and attorneys' fees, if appropriate. Employee Protection 11 ------- If an employee believes that his employer has discriminated against him because of the employee's participation in carrying out TSCA, he may file a complaint with the Secretary of Labor. The Secretary shall investigate the alleged discrimination and, if warranted, may order the employer to remedy the effects of any such discrim- inatory action. Employees and employers may obtain judicial review in the U.S. Courts of Appeals. EPA will evaluate the potential effects on employment of regulatory actions under TSCA. In response to a petition by an employee, EPA may investigate and hold public hearings concerning job losses or other adverse effects allegedly resulting from a requirement under TSCA. The Agency will make public these findings and recommendations. Civil and Criminal Penalties Any person who fails or refuses to comply with any requirement made under TSCA may be subject to a civil penalty of up to $25,000 for each day of violation. Persons who knowingly or willfully violate the law, in addition to any civil penalties, may be fined up to $25,000 for each day of viola- tion, imprisoned up to a year, or both. Enforcement EPA can inspect any establishment in which chemicals are manufactured, pro- cessed, imported to, stored, or held before or after their distribution in com- merce. No inspection shall include finan- cial, sales, pricing, personnel, or research data, unless specified in an inspection notice. The Agency can subpoena witnesses, documents, and other information as nec- essary 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 substance or mixture that was manufactured, processed, or distributed in commerce in violation of TSCA may be subject to seizure. Specific enforcement strategies for im- plementing TSCA regulations have been developed by the Agency. 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 deter- mining civil penalties under the regulation. TSCA Assistance Office As required by TSCA, EPA has estab- lished an office to provide technical and other nonfinancial assistance to chemical manufacturers, processors and others who are interested in requirements and activities under this law To help people understand TSCA's requirements, the TSCA Assistance Office: (TAO) provides a toll-free telephone information service, a bi-monthly bulletin, field consultants and other technical assistance upon request. 12 ------- Further Information To obtain up-to-date information on TSCA requirements, call the TSCA Assistance Office's toll-free line: 800-424-9065 (554-1404 in Washington, D.C.). Outside of the United States call 202-554-1404. 13 ------- EPA REGIONAL OFFICES Regional Offices EPA Region 1 JFK Federal Building Boston, MA 02203 EPA Region 2 26 Federal Plaza New York, NY 10278 EPA Region 3 Curtis Building 6th and Walnut Streets Philadelphia, PA 19106 EPA Region 4 345CourtlandSt, NE Atlanta, GA 30365 EPA Region 5 230 South Dearborn Street Chicago, IL 60604 EPA Region 6 1201 Elm St. Dallas, TX 75270 EPA Region 7 324 East 11th St. Kansas City, MO 64106 EPA Region 8 1860 Lincoln Street Denver, CO 80295 EPA Region 9 215 Fremont St. San Francisco, CA 94105 EPA Region 10 1200 Sixth Avenue Seattle, WA 98101 States Covered Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont New Jersey, New York Virgin Islands, Puerto Rico Delaware, Maryland, Pennsylvania, Virginia, West Virginia, District of Columbia Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee Indiana, Illinois, Michigan, Minnesota, Ohio, Wisconsin Arkansas, Louisiana, New Mexico, Oklahoma, Texas Iowa, Kansas, Missouri, Nebraska Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming Arizona, California, Hawaii, Nevada, American Samoa, Guam, Trust Territories of the Pacific, Wake Island Alaska, Idaho, Oregon, Washington 14 ------- |