TSCA: From Inception to Reform 

For more information on the project, see the webinar “From Inception to Reform” hosted by the Environmental Leadership Program.

Calls for chemical reform have gained momentum at the state and national levels. While nearly everyone involved can agree that change is needed, debates center on whether or not TSCA—the Toxic Substances Control Act—can still work as the backbone of a chemicals policy in the United States.

In this oral-history project we conduct in-depth interviews with individuals involved in the process of writing and negotiating TSCA: we gain their perspective on the law, what it has done, and whether or not it can continue to work in the 21st century. 


Staff: Jody Roberts, Elizabeth McDonnell, Kavita Hardy

 What Is TSCA?

The Toxic Substances Control Act of 1976 (TSCA) authorizes the U.S. Environmental Protection Agency (EPA) to require industry reporting, record-keeping, and testing of chemical substances in commerce. TSCA also requires the EPA to evaluate the risks of chemical substances and, when proven necessary, requires risk-management actions ranging from labeling to banning.

Several sections of TSCA outline the major pieces of the Toxic Substances Program:

  • Section 4 addresses testing, authorizing the EPA to require manufacturers, importers, and processors to test their chemicals when risks or exposures of concern have been identified.

  • Section 5 outlines “new chemicals,” which are chemicals first manufactured after a 1978 deadline. It authorizes the EPA to require manufacturers or importers to submit pre-manufacture notices for new chemicals, which are subject to EPA review. It also authorizes the EPA to issue “significant new use rules” for existing chemicals.

  • Section 6 addresses existing chemicals, authorizing the EPA to require risk-abatement action provided that an “unreasonable risk of injury to health or the environment” from a chemical substance has been proven. Possible actions include labeling chemical substances, regulating uses, restrictions on disposal, and prohibiting or limiting manufacture.

  • Section 8 refers to reporting and record-keeping on existing chemicals, allowing the EPA to request data on the properties, manufacture, exposure, and health and environmental effects of existing chemicals. It also authorizes the EPA to require industry record-keeping of adverse effects from their chemicals on health or the environment as well as lists of existing health and safety studies on the chemical substance. Industry is required to inform the EPA if they obtain information suggesting that a chemical substance has a significant risk of injury.

  • Section 6(e) requires the EPA to regulate polychlorinated biphenyls (PCBs), while Titles 2, 3, and 4 directly regulate the production, importation, use, and disposal of asbestos, radon, and lead-based paint.

 TSCA’s History

After a series of pesticide and worker-related chemical scares in the late 1960s and early 1970s, the American public and government leaders became increasingly concerned. In 1970 J. Clarence (Terry) Davies and Charles L. Lettow, staff members of the newly formed President’s Council on Environmental Quality, drafted a chemicals bill to address these concerns. The council also released an influential report in 1971, “Toxic Substances,” justifying a federal chemicals law. The draft bill received sharp resistance from the Department of Commerce and the legislative clearinghouse, the Office of Management and Budget.

A weakened bill was introduced in Congress in spring 1971, but the initiative died in 1972 owing to House-Senate disagreements. Over the next four years the bill was repeatedly introduced. Industry, as well as many members of the House of Representatives, were opposed to strong regulation, but after the heavily publicized Kepone disaster and an imminent new administration, TSCA was finally passed in 1976.

An Office of Toxic Substances (OTS) had already been created in the EPA, and the OTS spent the remainder of the 1970s and the beginning of the 1980s creating technological and administrative infrastructures, as well as writing rules, to enact the new law. It also cooperated in international efforts to standardize testing, until the change of administration in 1982. Industry proved surprisingly cooperative about the new chemical provisions, partially because the OTS tended to interpret TSCA cautiously, allowing industry to abuse claims of confidential business information, for example. Congress was not interested in guiding the OTS toward a more ambitious agenda because the committees responsible for TSCA’s oversight were not the same ones responsible for its development.

By the mid-1980s the OTS began moving toward more negotiated and voluntary regulation. It had become clear that the TSCA mechanisms were bureaucratic and burdensome, but at the same time, the OTS was in the midst of a 10-year effort to regulate asbestos using Section 6 of TSCA. In a landmark case, Corrosion Proof Fittings v. EPA, the appellate court overturned the EPA’s asbestos ban. After the case the OTS determined that Section 6—which gives the EPA authority to regulate chemicals that pose a risk of harm—was too burdensome to use, solidifying the OTS’s preference for voluntary measures.

Now without the authority to regulate chemicals, in 1990 the OTS refocused its efforts on revitalizing the information-gathering component of the existing chemicals program. The new chemicals-review program, which had developed into a sophisticated plan for modeling and evaluating toxicity of new chemicals, seemed to be averting new crises. However, Congress held a number of hearings in 1992 with the intention of reauthorizing a stronger TSCA. This initiative ultimately failed.

Throughout the late 1990s and 2000s the OTS continued to focus on gathering data on existing chemicals. In 1999 the OTS introduced its High Production Volume Challenge program to encourage industry to submit basic health and safety data for the existing chemicals imported or produced in quantities of one million pounds or more per year. In 2007 the OTS introduced the Chemical Assessment and Management Program to develop screening-level hazard, exposure, and risk characterizations for chemicals produced or imported in quantities of 25,000 pounds or greater a year.

In the last two years calls for reform have emerged from the general public, the nonprofit sector, the EPA, Congress, and even industry. In response to this current climate the staff of CHF’s Environmental History and Policy Program interviewed 12 former OTS staff members to elucidate TSCA’s regulatory past and offer a unique perspective for decision-makers currently involved in the reform efforts.

 Interviewees for the TSCA Oral History Project

James V. Aidala | Between 1975 and 1993 Aidala worked for the pesticides program in the Office of Pesticides and Toxic Substances, on two Congressional committees, and with the Congressional Research Service, with a focus on TSCA and FIFRA implementation. He was the associate assistant administrator of the Office of Prevention, Pesticides and Toxic Substances from 1993 to 2000. He is currently a research associate with the law firm Bergeson & Campbell, where he speaks and writes on TSCA reform.

Charles M. Auer | Auer spent 33 years in the OTS, starting as a staff chemist in 1976 and concluding as director from 2002 to 2009. His experience ranges from new chemicals, to existing chemicals, to chemicals control, although most of his career was focused on developing and using structure activity relationships for evaluating chemical toxicity. After retiring from the EPA, he established the environmental consulting firm Charles Auer & Associates. He is also an affiliate with the law firm Bergeson & Campbell, where he speaks and writes on TSCA reform.

Marilyn C. Bracken | Bracken started her career at the National Bureau of Standards, and then did information-systems analysis at the Department of Agriculture, the Consumer Product Safety Commission, and MITRE Corporation. She moved to the OTS in 1978 to be the first deputy assistant administrator for program administration and later the associate assistant administrator of toxics integration. She was responsible for establishing the TSCA Inventory and facilitating international collaboration. She left the EPA with the change in administration in 1983. She now works for the Institute for Defense Analysis.

Don R. Clay | After several years in industry, the U.S. Food and Drug Administration, and the U.S. Consumer Product Safety Commission, in 1981 Clay became the director of the OTS. He remained director through much of the Reagan administration, where he was influential in determining the scope of TSCA, but left the OTS in 1986. He continued to work in the EPA until 1993, first in the Office of Air and Radiation and then in the Office of Solid Waste and Emergency Response. From 1998 until retirement in 2010 he was director and then vice president of environmental and regulatory affairs at Koch Industries.

J. Clarence “Terry” Davies | Davies began his 40-year relationship with toxics as an assistant professor at Princeton University. In 1970 he published The Politics of Pollution, which included a chapter on the need for a chemicals policy. That same year, he was invited to be a staff member on the newly formed President’s Council on Environmental Quality. There he was responsible for co-drafting what eventually became TSCA. He then spent several years working at nonprofits and think tanks but returned to the government to serve as the EPA deputy administrator from 1989 to 1991. He is currently a senior fellow at Resources for the Future, where he has written extensively about TSCA reform.

Charles (Chuck) L. Elkins | Elkins spent 15 years working in several of EPA’s regulatory programs before becoming director of the OTS from 1986 to 1990. He oversaw the OTS’s promulgation of the Section 6 ban on the use of asbestos in most products—a regulation that was overturned by the 5th Circuit Court of Appeals in the influential Corrosion Proof Fittings case because that court believed that the regulation did not meet the stringent requirements of Section 6. Elkins also oversaw the initial implementation of the Toxics Release Inventory program.  From the OTS, Elkins moved to the EPA Office of General Counsel as Associate General Counsel for four years. After leaving the EPA, Elkins worked at the environmental consulting firm of Jellinek, Schwartz & Connolly for another four years before starting his own environmental consulting firm, Chuck Elkins & Associates. He continues to practice part time and in the meantime has founded and currently manages the EPA Alumni Association.

E. Donald Elliott | Elliott was general counsel at the EPA from 1989 to 1991, during the Corrosion Proof Fittings v. EPA case. He is currently a practicing lawyer and is a professor of environmental law at Yale and Georgetown universities. He is also partner and chair of the environmental law department at the firm Willkie, Farr & Gallagher.

Linda J. Fisher | Fisher worked as a staff member in the U.S. House of Representatives from 1974 to 1980. In 1983, after receiving her J.D., she moved to the EPA. She was the assistant administrator of the Office of Prevention, Pesticides and Toxic Substances (formerly the Office of Pesticides and Toxic Substances) from 1989 to 1993, where she was influential in the office’s response to the Corrosion Proof Fittings case. She has been the vice president of safety, health, and environment at DuPont since 2004; she has testified about TSCA reform before Congress multiple times on the behalf of DuPont.

Mark Greenwood | After finishing his law degree in the new field of environmental law, Greenwood worked in the EPA Office of General Counsel from 1978 to 1990. He worked on RCRA and Superfund before spending his last two years as general counsel on pesticides and toxic substances. After leaving the Office of General Counsel, he became the director of the Office of Pollution Prevention and Toxics (formerly the Office of Toxic Substances) from 1990 to 1994. He oversaw the aftermath of the Corrosion Proof Fittings case and the office’s transition to pollution prevention. He is currently a partner in the law firm Ropes & Gray LLC, where he has published about TSCA reform.

Steven D. Jellinek | After a 10-year career with the Internal Revenue Service, Jellinek was among the first employees of the President’s Council on Environmental Quality. From there he was recruited to be the first assistant administrator of the Office of Toxic Substances at the EPA after TSCA was enacted. He served in that position from 1977 through 1981, shaping the office’s administrative and technological infrastructure, and then cofounded the pesticide consulting firm Jellinek, Schwartz & Connolly.

Victor J. Kimm | Kimm received bachelor’s and master’s degrees in civil (then sanitary) engineering. He became deputy assistant administrator in the Office of Pesticides and Toxic Substances (OPTS), where he oversaw chemical regulation, resulting in re-registration and the modernizing of outdated protocols. During his 10 years as deputy assistant administrator, OPTS was responsible for implementing the Toxic Substances Control Act (TSCA).  

Charles F. Lettow | Soon after completing his law degree, Lettow worked as counsel for the President’s Council on Environmental Quality. In 1971 he collaborated with Terry Davies to compose the first draft of what eventually became TSCA. He then practiced law, with a focus on environmental issues, for 20 years. He currently serves as a judge for the U.S. Court of Federal Claims.

Warren R. Muir | Muir joined the President’s Council on Environmental Quality immediately after completing his doctorate in chemistry. From there he became the first deputy assistant of testing and evaluation in the Office of Toxic Substances at the EPA, where he was responsible for establishing the new chemicals program. When the OTS expanded to include the Pesticides Program, he became the first director of the OTS. He left the OTS in 1981 and eventually founded the environmental consulting firm Hampshire Research Associates. He is currently the executive director of the Division of Earth and Life Sciences at the National Academy of Sciences.

Glenn E. Schweitzer | Glenn E. Schweitzer received his master’s degree in nuclear engineering. He began his career as a Foreign Service Officer, moved to the staff of the Vice President’s Marine Science and Technology Council, and finally accepted a position at the U.S. Agency for International Development. He was then asked to manage the new Office of Toxic Substances (OTS) in the U.S. Environmental Protection Agency (EPA) in 1974. He had four tasks: to ensure that the Toxic Substances Control Act (TSCA) passed quickly; to deal with the “chemical of the month”; to help the Office of Air and Water deal with toxic chemicals under the their legislative authorities—the Clean Air Act and the Clean Water Act; and to upgrade data, especially testing data, being used throughout EPA.

 

This video features the November 19, 2010, AAAS-CCHP History Seminar, “From Inception to Reform: Unpacking the History of the Toxic Substances Control Act through Archives and Oral Histories.” Speakers are Jody Roberts and Jessica Schifano. 

Video courtesy of AAAS.

Events:

A public discussion, “TSCA: From Inception to Reform,” was held at the American Association for the Advancement of Science in Washington, D.C., on Thursday, March 3, 2011. Panelists included: 

  • James V. Aidala
  • Charles M. Auer
  • Charles L. Elkins
  • Mark A. Greenwood
  • Glenn E. Schweitzer

Here is the video footage of the March 3 discussion:

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