# Toxic Substances Control Act, United States

March 28, 2012, 3:04 pm
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Illegally Dumped Drums, East Boston, Massachusetts. Source: Massachusetts Department of Environmental Protection

The Toxic Substances Control Act (TSCA, 15 U.S.C. 2601 et seq.) authorizes the U.S. Environmental Protection Agency (EPA) to screen existing and new chemicals used in U.S. manufacturing and commerce to identify potentially dangerous products or uses that should be subject to federal control. Both naturally occurring and synthetic chemicals are subject to TSCA, with the exception of chemicals regulated under other federal laws concerning food, drugs, cosmetics, firearms, ammunition, pesticides, tobacco, or mixtures. 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 must 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.

As enacted, TSCA also included a provision requiring EPA to take specific measures to control the risks from polychlorinated biphenyls (PCBs) (Section 6(e)). The original legislation included a single title, which has since been designated Title I. It was amended in 2008 to restrict sales of elemental mercury (P.L. 110-414). In addition, four titles have been added to address specific concerns—asbestos in 1986 (Title II, P.L. 99-519), radon in 1988 (Title III, P.L. 100-551), lead in 1992 (Title IV, P.L. 102-550), and schools (Title V, P.L. 110-140). Title II directs EPA to set standards for asbestos mitigation in schools and requires asbestos contractors to be trained and certified. Title III directs EPA to provide technical assistance to states that choose to support radon monitoring and control. Title IV provides similar assistance with respect to abatement of lead-based paint hazards. Finally, Title V addresses environmental issues at schools, including energy efficiency.

## History

Table 1. Toxic Substances Control Act and Major Amendments

 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 1999 Asbestos School Hazard Abatement Reauthorization Act P.L. 101-637 1992 Residential Lead-Based Paint Hazard Reduction Act of 1992 P.L. 102-550 2007 Energy Independence and Security Act of 2007, Subtitle E - Healthy High-Performance Schools P.L. 110-140 2008 Mercury Export Ban Act of 2008 P.L. 110-414

## Background

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 (in 1972 and 1973, respectively), but controversies over the scope of chemical screening prior to commercial production and distribution, level of costs, and the relationship to other regulatory laws stalled final action. Episodes of environmental contamination—including 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.

## Title I

TSCA (Title I) directs EPA to

• require manufacturers and processors to conduct tests for existing chemicals if (1) their manufacture, distribution, processing, use, or disposal may present an unreasonable risk of injury to health or the environment; or they are to be produced in substantial quantities and the potential for environmental release or human exposure is substantial or significant; (2) existing data are insufficient to predict the effects of human exposure and environmental releases; and (3) testing is necessary to develop such data (Section 4);
• prevent future risks through pre-manufacture screening and regulatory tracking of new chemical products (Section 5);
• control unreasonable risks already known, or as they are discovered for existing chemicals (Section 6); and
• gather and disseminate information about chemical production, use, and possible adverse effects to human health and the environment (Section 8).

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 U.S. 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 six 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. TSCA directs the ITC to “designate” a subset of chemicals on the list for EPA action within 12 months. The list can contain no more than 50 “designated” chemicals at any time. When a chemical is designated, 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.

### Pre-manufacture Notification for New Chemicals or Uses

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 United States. 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 from previously permitted uses, if the Administrator has determined by rule that new uses of the chemical may produce significant changes in human and environmental exposures and therefore require notification. The 90-day notice provides EPA with the opportunity to evaluate the chemical use and, if necessary, to prohibit or limit such activity before it occurs to prevent unreasonable risk of injury to human health or the environment.

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 more than 1,000 new chemical manufacturing notices annually.

### Regulatory Controls for Hazardous Chemicals

TSCA requires EPA to regulate manufacturing, processing, distribution in commerce, use, or disposal of a chemical if it will present an unreasonable risk of injury to health or the environment, and the risk cannot be reduced to a sufficient degree under another federal law administered by EPA. 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:

• prohibit or limit the amount of production or distribution of a substance in commerce;
• prohibit or limit the production or distribution of a substance for a particular use;
• limit the volume or concentration of the chemical produced;
• prohibit or regulate the manner or method of commercial use;
• require warning labels and/or instructions on containers or products;
• require notification of the risk of injury to distributors and, to the extent possible, consumers;
• require record-keeping by producers;
• specify disposal methods; and
• require replacement or repurchase of products already distributed.

EPA also may impose any of these requirements in combination, or for a specific geographical region. However, EPA is required by TSCA to regulate only “to the extent necessary to protect adequately” against a risk, and 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 United States. 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 U.S. commerce. Chemicals need not be listed if they are only produced in very small quantities for purposes of experimentation or research.

Two chemical substances are directly addressed in Title I: PCBs and elemental mercury. TSCA directs EPA to regulate PCBs and to ban most uses. In addition, TSCA prohibits the sale, distribution, or transfer of elemental mercury by federal agencies. 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.

Manufacturers, processors, and distributors of chemicals are required to maintain records of significant adverse reactions to health or the environment alleged to have been caused by a substance or mixture. Records of adverse effects on the health of employees must 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.

Concern about how schools would pay for required actions was addressed in separate legislation (the Asbestos School Hazard Abatement Act of 1984, or ASHAA, P.L. 98-377). It established a program offering grants and interest-free loans to schools with serious asbestos problems and demonstrated financial need. Although EPA for several years did not request funding for this program, Congress appropriated funds. Authorization of appropriations for this program expired September 30, 1995, and Congress has not appropriated funds since FY1993; a total of $382 million in grant and loan funds were appropriated from FY1984 through FY1993. Repaid ASHAA loans are returned to an Asbestos Trust Fund, established in TSCA Title II, to become a dedicated source of revenues for future asbestos control projects. ## Title III (Radon Programs) In October 1988 Congress amended TSCA by adding Title III—Indoor Radon Abatement (15 U.S.C. 2661 et seq., P.L. 100-551). The basic purpose of Title III is to provide financial and technical assistance to the states that choose to support radon monitoring and control; neither monitoring nor abatement of radon is required by the act. Title III required EPA to update its pamphlet “A Citizen’s Guide to Radon,” to develop model construction standards and techniques for controlling radon levels within new buildings, and to provide technical assistance to states. EPA is to provide technical assistance by: establishing an information clearinghouse; publishing public information materials; establishing a national database of radon levels detected, organized by state; providing information to professional organizations representing private firms involved in building design and construction; submitting to Congress a plan for providing financial and technical assistance to states; operating cooperative projects with states; conducting research to develop, test, and evaluate radon measurement methods and protocols; developing and demonstrating new methods of radon measurement and mitigation, including methods that are suitable for use in nonresidential child care facilities; operating a voluntary program to rate radon measurement and mitigation devices and methods and the effectiveness of private firms and individuals offering radon-related services; and designing and implementing training seminars. The proficiency rating program and certification for training programs collect fees for service, and therefore, are meant to be self-supporting, but Congress authorized$1,500,000 to be appropriated to establish these programs. Congress authorized $3,000,000 to be appropriated for each of three years beginning in 1989 for the other provisions of Sections 303, 304, and 305. A matching grant program was established for the purpose of assisting states in developing and implementing programs for radon assessment and mitigation. For this program,$30 million was authorized to be appropriated over three years, with funds targeted to states or projects that made efforts to ensure adoption of EPA’s model construction standards and techniques for new buildings; gave preference to low-income persons; or addressed serious and extensive radon contamination problems or had the potential to reduce risk or to develop innovative assessment techniques, mitigation measures, or management approaches.

Other sections of Title III require EPA to: conduct a study to determine the extent of radon contamination in schools; identify and list areas of the U.S. with a high probability of having high levels of indoor radon; make grants or cooperative agreements to establish and operate at least three regional radon training centers; and provide guidance to federal agencies on radon measurement, risk assessment, and remedial measures.

All authorizations for appropriations specific to this title expired September 30, 1991, although appropriations have continued.

## Title IV (Lead Exposure Reduction)

The 102nd Congress added Title IV to TSCA when it enacted the Residential Lead-Based Paint Hazard Reduction Act of 1992 as Title X in the Housing and Community Development Act of 1992 (P.L. 102-550). Title IV aims to accelerate federal efforts to reduce risks to young children who daily are exposed to lead-based paint in their homes. In addition, it is expected to stimulate development of lead inspection and hazard abatement services in the private sector, while ensuring that the services provided and any products employed are reliable and effective in reducing risk. To these ends, Title IV directs EPA:

• to ensure that people engaged in detection and control of lead hazards are properly trained and that contractors are certified;
• to publish requirements for the accreditation of training programs for workers; • to develop criteria to evaluate the effectiveness of commercial products used to detect or reduce risks associated with lead-based paint;
• to establish protocols, criteria, and minimum performance standards for laboratory analysis of lead in paint films, soil, and dust;
• to establish a program to certify laboratories as qualified to test substances for lead content; and
• to publish and distribute to the public a list of certified or accredited environmental sampling laboratories.

Title IV explicitly applies these requirements to federal facilities and activities that may create a lead hazard.

In addition, Congress directed EPA to conduct a study of lead hazards due to renovation and remodeling activities that may incidentally disturb lead-based paint. EPA is required to promulgate guidelines for the renovation and remodeling of buildings or other structures when these activities might create a hazard.

Title IV directs EPA to establish a clearinghouse and hotline to distribute information about the hazards of lead-based paint, how to avoid exposure and reduce risk, and new technologies for removing or immobilizing lead-based paint. In addition, Congress mandated development of: a lead hazard information pamphlet; public education and outreach activities for health professionals, the general public, homeowners, landlords, tenants, consumers of home improvement products, the residential real estate industry, and the home renovation industry; and information to be distributed by retailers of home improvement products to provide consumers with practical information related to the hazards of renovation where lead-based paint may be present.

Title IV authorizes states to propose programs to train and certify inspectors and contractors engaged in the detection or control of lead-based paint hazards. States also may develop the required informational pamphlets. TSCA requires EPA to promulgate a model state program that may be adopted by any state. Congress gave EPA the authority to approve or disapprove authorization for state proposals and to provide grants for states to develop and implement authorized programs. A federal program must be established, administered, and enforced by EPA in each state without an authorized program.

The Department of Health and Human Services also has responsibilities under Title IV of TSCA. It mandates a study by the Centers for Disease Prevention and Control (CDC) and the National Institute for Environmental Health Sciences to determine the sources of lead exposure to children who have elevated lead levels in their bodies. The National Institute for Occupational Safety and Health is directed to study ways of reducing occupational exposure to lead during abatement activities.

The act established a rule-making docket to ensure the availability to the general public of all documents submitted to agencies that are relevant to regulatory decisions pursuant to this legislation. The docket is required to include the drafts of all proposed rules submitted by EPA to the President’s Office of Management and Budget (OMB), written comments on the drafts, and written responses to comments. In addition, the agency must provide an explanation for any major change to a proposed rule that appears in the final rule, and such changes may not be made based on information not filed in the docket. Dockets are required to be established in each EPA regional office.

Congress authorized to be appropriated “such sums as may be necessary” for TSCA Title IV. In addition to amending TSCA, Title X of the Housing and Community Development Act of 1992 authorized grants to states for risk assessments and lead-based paint removal and immobilization in private housing for low-income residents; establishing state training, certification, or accreditation programs for inspectors and abatement contractors; and research at the Department of Housing and Urban Development (HUD). Authorization for appropriations for these grants expired September 30, 1994, but appropriations have continued. Title X directed HUD to establish guidelines for federally supported work involving risk assessments, inspections, interim controls, and abatement of lead-based paint hazards. In addition, the National Institute for Occupational Safety and Health (NIOSH) was provided $10 million for training people who remove or immobilize paint. ## Title V (Reducing Risks in Schools) At the end of 2007, the 110th Congress added a fifth title to TSCA, subtitled Healthy High- Performance Schools. Enacted as Title IV, Subtitle E (section 461) of P.L. 110-140, the Energy Independence and Security Act of 2007, TSCA Title V authorizes EPA to establish a state grant program to provide technical assistance for EPA programs to schools and develop and implement state school environmental health programs. State programs must include standards for school building design, construction, and renovation, and identify ongoing school building environmental problems and recommended solutions. Environmental problems specifically mentioned in the law include “contaminants, hazardous substances, and pollutant emissions.” EPA’s authority to provide grants expires five years after the date of enactment. Title V requires the EPA Administrator, in consultation with the Secretary of Education and the Secretary of Health and Human Services, to issue voluntary guidelines within 18 months of Title V enactment for selecting sites for schools (presumably new schools). The guidelines are to account for the “special vulnerability of children to hazardous substances or pollution exposures in any case in which the potential for contamination at a potential school site exists,” modes of transportation available to students and staff, efficient use of energy, and potential use of a school at the site as an emergency shelter. Title V also requires the EPA Administrator, in consultation with the Secretary of Education and the Secretary of Health and Human Services, to issue voluntary guidelines within two years of enactment for developing and implementing state environmental health programs for schools. These guidelines must take into account the findings of federal initiatives established under “relevant federal law with respect to school facilities,” including initiatives related to water and energy conservation authorized by sections 431 through 441, and work related to highperformance green buildings authorized by section 492 of P.L. 110-140. In particular, the guidelines must take into account “environmental problems, contaminants, hazardous substances, and pollutant emissions”; natural day lighting; ventilation; heating and cooling; moisture control and mold; maintenance, cleaning, and pest control; acoustics; and “other issues relating to the health, comfort, productivity, and performance of occupants of the school facilities.” In addition, Title V requires that the guidelines provide “technical assistance on siting, design, management, and operation of school facilities”; collaborate with children’s environmental health centers in school environmental investigations”; assist states and the public to better understand and improve the environmental health of children; and take into account “the special vulnerability of children in low-income and minority communities to exposures from contaminants, hazardous substances, and pollutant emissions.” Several provisions in Title V refer to entities established under other sections of the Energy Independence and Security Act of 2007 (P.L. 110-140). For example, Title V contains directives for the Federal Director of the Office of Federal High-Performance Green Buildings in the General Services Administration, which was created by section 436(a). In addition, there is reference to the national high-performance green building clearinghouse established in section 423(1) “to carry out public outreach to inform individuals and entities of the information and services [related to high-performance green buildings] available governmentwide.” Title V requires the Federal Director to ensure, “to the maximum extent practicable,” that the public clearinghouse “receives and makes available information on the exposure of children to environmental hazards in school facilities.” The EPA Administrator is directed to prepare an annual report to Congress on activities carried out under Title V authority, and this report also must be made available to the public through the clearinghouse. For the purposes of carrying out the provisions of Title V, Congress authorized appropriations of$7 million through FY2013.

Note: This article was extracted from from the Congressional Research Service Report RL30798, Environmental Laws: Summaries of Major Statutes Administered by the Environmental Protection Agency by David M. Bearden, Claudia Copeland, Linda Luther, James E. McCarthy, Linda-Jo Schierow, and Mary Tiemann (October 8, 2010).

• Bergeson, Lynn L. 2000. TSCA: Toxic Substances Control Act. Basic Practice Series. American Bar Association, Chicago, Illinois. 151 pp.
• Bergeson, Lynn L., Lisa M. Campbell, and Lisa Rothenberg. 2000. TSCA and the Future of Chemical Regulation, EPA Administrative Law Reporter, v. 15, n. 4, 23 pp.
• Hathaway, Carolyne R., David J. Hayes, and William K. Rawson. “A Practitioner’s Guide to the Toxic Substances Control Act: Part I.” Environmental Law Reporter, v. 24, May 1994, pp. 10207-10230.
• —— Part II. Environmental Law Reporter, v. 24, June 1994, pp. 10285-10304.
• —— Part III. Environmental Law Reporter, v. 24, July 1994, pp. 10357-10405.

 Disclaimer: This article is taken wholly from, or contains information that was originally published by, the Congressional Research Service. Topic editors and authors for the Encyclopedia of Earth may have edited its content or added new information. The use of information from the Congressional Research Service should not be construed as support for or endorsement by that organization for any new information added by EoE personnel, or for any editing of the original content.

Glossary

### Citation

Service, C. (2012). Toxic Substances Control Act, United States. Retrieved from http://www.eoearth.org/view/article/156670