Toxic Substances Control ActPrepared by Linda Schierow, Specialist in Environmental Policy,
CONTENTS FOR THIS SECTION
Table 1. Toxic Substances Control Act and Major Amendments
Testing of Chemicals
Relation to Other Laws
Enforcement and Judicial Review
Confidential Business Information
The Toxic Substances Control Act (TSCA, 15 U.S.C. 2601 et seq.) authorizes EPA to screen existing and new chemicals used in manufacturing and commerce to identify potentially dangerous products or uses that should be subject to federal control. As enacted, TSCA also included a provision requiring EPA to take specific measures to control the risks from polychlorinated biphenyls (PCBs) [Section 6(e)]. Subsequently, three titles have been added to address concerns about other specific toxic substances--asbestos in 1986 (Title II, P.L. 99-519), radon in 1988 (Title III, P.L. 100-551), and lead in 1992 (Title IV, P.L. 102-550).
EPA may require manufacturers and processors of chemicals to conduct and report the results of tests to determine the effects of potentially dangerous chemicals on living things. Based on test results and other information, EPA may regulate the manufacture, importation, processing, distribution, use, and/or disposal of any chemical that presents an unreasonable risk of injury to human health or the environment. A variety of regulatory tools is available to EPA under TSCA ranging in severity from a total ban on production, import, and use to a requirement that a product bears a warning label at the point of sale. TSCA directs EPA to use the least burdensome option that can reduce risk to a level that is reasonable given the benefits provided by the chemical product or process.
Table 1. Toxic
Substances Control Act and Major Amendments
(codified as 15 U.S.C. 2601-2671)
|Year||Act||Public Law Number|
|1976||Toxic Substances Control Act||P.L. 94-469|
|1986||Asbestos Hazard Emergency Response Act||P.L. 99-519|
|1988||Radon Program Development Act||P.L. 100-551|
|1990||Radon Measurement||P.L. 101-508, § 10202|
|1990||Asbestos School Hazard Abatement Reauthorization Act||P.L. 101-637|
|1992||Residential Lead-Based Paint Hazard
Reduction Act of 1992
Federal legislation to control toxic substances was originally proposed in 1971 by the President's Council on Environmental Quality. Its report, "Toxic Substances," defined a need for comprehensive legislation to identify and control chemicals whose manufacture, processing, distribution, use, and/or disposal was potentially dangerous and not adequately regulated under other environmental statutes. The House and Senate each passed bills in both the 92nd and 93rd Congresses, but controversies over the scope of chemical screening prior to commercial production and distribution, costs, and the relationship to other regulatory laws stalled final action. Episodes of environmental contamination--including contamination of the Hudson River and other waterways by PCBs, the threat of stratospheric ozone depletion from chlorofluorocarbon (CFC) emissions, and contamination of agricultural produce by polybrominated biphenyls (PBBs) in the state of Michigan--together with more exact estimates of the costs of imposing toxic substances controls, opened the way for final passage of the legislation. President Ford signed the TSCA into law on October 11, 1976.
TSCA (Title I) directs EPA to:
Authorization for appropriations for these activities and a state grant program for control of toxic substances in the environment expired on September 30, 1983, although appropriations for these programs have continued.
Testing of Chemicals. Many chemicals, even some in widespread use, are not well characterized in terms of their potential health and environmental effects. One of the major goals of TSCA was to induce the development of test data by producers (i.e., manufacturers, importers, and processors) of chemicals in commerce. Section 4 of TSCA directs EPA to require the development of test data on existing chemicals when certain conditions prevail: 1) the manufacture, processing, distribution, use, or disposal of the chemical "may present an unreasonable risk," or 2) the chemical is produced in very large volume and there is a potential for a substantial quantity to be released into the environment or for substantial or significant human exposure. Under either condition, EPA must issue a rule requiring tests if: a) existing data are insufficient to resolve the question of safety, and b) testing is necessary to develop the data.
Because there were more than 55,000 chemicals in commerce at the time EPA was to begin developing test rules, Congress established a special interagency committee to help EPA determine which chemicals should be considered first and to coordinate testing needs and efforts among government agencies. At least every 6 months the Interagency Testing Committee (ITC) must consider candidate chemicals for inclusion on a list of substances that the ITC recommends to EPA for development and promulgation of test rules. The list can contain no more than 50 chemicals at any time. When a chemical is added to the list, EPA has one year to respond by issuing a proposed test rule or a notice explaining why no testing is needed.
TSCA requires the ITC to consider the following factors when it makes listing decisions: 1) quantity of the substance to be manufactured, 2) quantity of the chemical in environmental releases, 3) number of people who will be exposed occupationally and the duration of exposure, 4) extent of non-occupational human exposure, 5) similarity of the chemical to any other chemical known to present an unreasonable risk, 6) existence of data concerning environmental or health effects of the chemical, 7) the quantity of information to be gained by testing, and 8) the availability of facilities and personnel for performing testing. Chemicals known or suspected to cause or contribute to cancer, gene mutations, or birth defects are to be assigned a higher priority. In response to information that indicates "there may be a reasonable basis to conclude that a chemical ... presents or will present a significant risk of serious or widespread harm to human beings from cancer, gene mutations, or birth defects," TSCA requires EPA action to prevent or reduce that risk or publication of a finding that the risk is not unreasonable.
Premanufacture Notification. TSCA (Section 5) requires manufacturers, importers, and processors to notify EPA at least 90 days prior to producing or otherwise introducing a new chemical product into the U.S. Any information or test data that is known to, reasonably ascertainable by, or in possession of the notifier, and that might be useful to EPA in evaluating the chemical's potential adverse effects on human health or the environment, must be submitted to EPA at the same time. TSCA also requires EPA to be notified when there are plans to produce, process, or use an existing chemical in a way that differs significantly from previously permitted uses so that EPA may determine whether the new use poses a greater risk of human or environmental exposure or effects than the former use. EPA has 45 days after notification (or up to 90 days if it extends the period for good cause) to evaluate the potential risk posed by the chemical. If EPA determines that there is a reasonable basis to conclude that the substance presents or will present an unreasonable risk, the Administrator must promulgate requirements to protect adequately against such risk. Alternatively, EPA may determine that the proposed activity related to a chemical does not present an unreasonable risk; this decision may be based on the available data, or, when no data exist to document the effects of exposure, on what is known about the effects of chemicals in commerce with similar chemical structures and used in similar ways. The purpose of EPA's screening procedure is to identify potential hazards and control them before use of a chemical becomes widespread. If data are inadequate to make an informed judgment and 1) manufacture, processing, distribution in commerce, use, or disposal may present an unreasonable risk, or 2) a chemical is to be produced in substantial quantities and the potential for environmental release or human exposure is substantial or significant, EPA may issue a proposed order to prohibit or limit such activities until sufficient data are submitted.
Although the legislative history of TSCA includes a presumption that testing of new products would take place before they were widely used, either as the chemical was developed, or as its markets grew, TSCA also forbids promulgation of blanket testing requirements for all new chemicals. This reflects concern that uniform testing requirements might stifle innovation in the chemical industry. Thus, EPA must decide which chemicals, or which categories of chemicals, warrant the costs of premarket testing. EPA reviews approximately 1,000 new chemical manufacturing notices annually.
Regulatory Controls. The alternative means available to EPA for controlling chemical hazards that present unreasonable risks are specified in Section 6 of TSCA. EPA has the authority to:
EPA also may impose any of these requirements in combination or for a specific geographical region. However, EPA is required by TSCA to use the "least burdensome" regulatory approach, even in controlling unreasonable risks.
Information Gathering. Section 8 of TSCA requires EPA to develop and maintain an inventory of all chemicals, or categories of chemicals, manufactured or processed in the U.S. The first version of this inventory identified approximately 55,000 chemicals in commerce in 1979. All chemicals not on the inventory are, by definition, "new" and subject to the notification provisions of Section 5. These chemicals must be added to the inventory if they enter commerce. Chemicals need not be listed if they are only produced in very small quantities for purposes of experimentation or research.
To aid EPA in its duties under TSCA, the Agency was granted considerable authority to collect information from industries. EPA may require maintenance of records and reporting of: chemical identities, names, and molecular structures; categories of use; amounts manufactured and processed for each category of use; descriptions of byproducts resulting from manufacture, processing, use, and disposal; environmental and health effects; number of individuals exposed; number of employees exposed and the duration of exposure; and manner or method of chemical disposal. In addition, manufacturers, processors, and distributors of chemicals must maintain records of significant adverse reactions to health or the environment alleged to have been caused by the substance or mixture. Records of adverse effects on the health of employees shall be retained for 30 years from the date of reporting. Industry also must submit lists and copies of health and safety studies. Studies showing adverse effects previously unknown must be submitted to EPA as soon as they are completed or discovered.
Imminent Hazards. Section 7 provides EPA authority to take emergency action through the district courts to control a chemical substance or mixture which presents an imminent and unreasonable risk of serious widespread injury to health or the environment.
Relation to Other Laws. Section 9 allows EPA to refer cases of chemical risk to other federal agencies with the authority to prevent or reduce the risk. For statutes under EPA's jurisdiction, TSCA gives the Administrator discretion to decide if a risk can best be handled under the authority of TSCA.
Enforcement and Judicial Review. Section 11 authorizes EPA to inspect any facilities subject to TSCA requirements and to issue subpoenas requiring attendance and testimony of witnesses, production of reports and documents, answers to questions and other necessary information. Section 13 mandates TSCA enforcement at the national borders by the Treasury Department.
Section 15 identifies acts prohibited under TSCA, while Section 16 describes penalties for acts violating these prohibitions, as well as recourse available to anyone accused of such violations. Section 16 authorizes civil penalties, not to exceed $25,000 per violation per day, and affords the defendant an opportunity to request a hearing before an order is issued and to petition for judicial review of an order after it is issued. Criminal penalties also are authorized for willful violations. Section 17 provides jurisdiction to U.S. district courts in civil actions to enforce TSCA Section 15 by restraining or compelling actions that violate or comply with it, respectively. Chemicals may be seized and condemned if their manufacture, processing, or distribution violated the Act.
Section 19 authorizes any person to file a petition for judicial review of specified rules within 60 days of issuance under TSCA. The court is directed to set aside specified rules if they are not supported by substantial evidence in the rulemaking record taken as a whole.
Section 20 authorizes civil suits by any person against any person in violation of the Act. It also authorizes suits against EPA to compel performance of nondiscretionary actions under TSCA. Section 21 provides the public with the right to petition for the issuance, amendment or repeal of a rule requiring toxicity testing of a chemical, regulation of the chemical, or reporting.
Confidential Business Information. Section 14 provides broad protection of proprietary confidential information about chemicals in commerce. Disclosure by EPA employees of such information generally is not permitted except to other federal employees or when necessary to protect health or the environment. Data from health and safety studies of chemicals is not protected unless its disclosure would reveal a chemical process or chemical proportion in a mixture. Wrongful disclosure of confidential data by federal employees is prohibited and may result in criminal penalties.
Chemical Categories. Section 26 allows EPA to impose regulatory controls on categories of chemicals, rather than on a case-by-case basis. However, EPA cannot regulate a group merely because it is composed of new chemical substances.
Other Provisions. TSCA Section 10 directs EPA to conduct and coordinate among federal agencies research, development, and monitoring that is necessary to the purposes of the Act.
Section 12 excludes chemical products manufactured for export from TSCA requirements except for reporting and record keeping requirements in Section 8.
State actions that are preempted by TSCA are described in Section 18.
Section 22 waives compliance when in the interest of national defense.
Section 23 provides protection of employees who assist in carrying out the provisions of the Act (i.e., "whistle-blowers").
The potential effects of TSCA rules on employment must be monitored by EPA, according to Section 24. Section 25 mandates study of the need for indemnification of people affected by federal laws administered by EPA and of the feasibility of establishing a standard classification system for chemical substances and of storing and retrieving information about them.
Section 26 authorizes data sharing and cooperative action to facilitate TSCA implementation between EPA and other federal agencies. It also authorizes collection of fees for EPA processing of data submitted in response to an order under Section 4 or 5. EPA is directed to establish an office to assist the regulated community. The Agency also must establish a procedure to ensure disclosure of financial interests in the regulated community by EPA employees. Final orders issued under TSCA must contain a statement of basis and purpose. Finally, Section 26 established within EPA a new Assistant Administrator for Toxic Substances.
TSCA Section 27 authorizes research and development of test methods for chemicals by the Public Health Service in cooperation with EPA.
Grants to states are authorized by Section 28 to establish and operate programs to prevent or eliminate unreasonable risks to health or the environment.
Section 29 authorized appropriations through 1983.
An annual report is mandated by Section 30.