Overview

The Toxic Substances Control Act (TSCA) is a United States law, passed by the United States Congress in 1976 and signed October 11, 1976, that regulates the introduction of new or already existing chemicals. It grandfathered most existing chemicals (about 62,000), in contrast to the newer Registration, Evaluation and Authorization of Chemicals (REACH) legislation of the European Union. TSCA addresses the production, importation, use, and disposal of specific chemicals including polychlorinated biphenyls (PCBs), asbestos, radon and lead-based paint.

Contrary to what the name implies, TSCA does not separate chemicals into categories of "toxic" and "non-toxic." Rather it prohibits the manufacture or importation of chemicals that are not on the TSCA Inventory (or subject to one of many exemptions). Chemicals that are listed on the TSCA inventory are referred to as "existing chemicals." Chemicals not listed are referred to as "new chemicals". Generally, manufacturers must submit premanufacturing notification to the U.S. Environmental Protection Agency (EPA) prior to manufacturing (or importing) new chemicals for commercial purposes. There are notable exceptions, including one for research and development, and for substances regulated under other statutes such as the Federal Food, Drug, and Cosmetics Act and the Federal Insecticide, Fungicide, and Rodenticide Act.

New chemicals notifications are reviewed by the Agency and if the Agency finds an "unreasonable risk to human health or the environment," it may regulate the substance in a variety of ways, from limiting uses or production volume to banning them outright.

In practice, however, TSCA is widely considered to be failed legislation. There is currently an effort in the US at chemical policy reform to replace TSCA.

Summary of TSCA Requirements

As summarized on the EPA web page, Summary of the Toxic Substances Control Act:

Various sections of TSCA provide authority to:

• Require, under Section 5, pre-manufacture notification for "new chemical substances" before manufacture

• Require, under Section 4, testing of chemicals by manufacturers, importers, and processors where risks or exposures of concern are found

• Issue Significant New Use Rules (SNURs), under Section 5, when it identifies a "significant new use" that could result in exposures to, or releases of, a substance of concern.

• Maintain the TSCA Inventory, under Section 8, which contains more than 83,000 chemicals. As new chemicals are commercially manufactured or imported, they are placed on the list.

• Require those importing or exporting chemicals, under Sections 12(b) and 13, to comply with certification reporting and/or other requirements.

• Require, under Section 8, reporting and recordkeeping by persons who manufacture, import, process, and/or distribute chemical substances in commerce.

• Require, under Section 8(e), that any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment to immediately inform EPA, except where EPA has been adequately informed of such information.

EPA screens all TSCA b§8(e) submissions as well as voluntary "For Your Information" (FYI) submissions. The latter are not required by law, but are submitted by industry and public interest groups for a variety of reasons.

Criticisms of TSCA

Below is a small sampling of opinions on the shortcomings of TSCA. To explore additional opinions, please see the references and additional links below. We also recommend perusing Environmental Health News to read current news on efforts to reform US chemical policy, including the Safe Chemical Act of 2010.

• Lowell Center for Sustainable Production, University of Massachusetts, accessed June 2010:
  The success of TSCA has been limited by several factors including a lack of data on chemicals in commerce; high burdens for agency action; a focus on review of new chemicals without adequate attention to existing chemicals; and a chemical-by-chemical approach to chemicals management. There has also been relatively little attention paid to chemicals in products. Due to these limitations, many EPA efforts to reduce and substitute chemicals are largely voluntary and dependent on the willingness of industry to participate.

• John Guth, J.D., Ph.D., Science & Environmental Health Network, April 2006:
  Though TSCA is broad in theory, its legal structure reflects an underlying assumption that only some of the chemicals in commerce are likely to be hazardous. It presumes that manufacturers have the right to market chemicals, and places a heavy burden on government to prove the need for regulation before it can interfere with that right. Today there is a growing recognition that many of the chemicals in commerce, and not just a few, are likely to constitute some type of hazard. On this view, the structure of TSCA contains two general overriding flaws. One is that the statute makes too little information available to the government, users of chemicals and consumers about the hazardous properties of chemicals. These data gaps make it impossible for the government to fully enforce the other environmental laws and for users of chemicals and consumers to choose safer chemicals and products. The second flaw in TSCA is that it places too high a legal burden on the government before it can regulate chemicals.

• US Government Accountability Office (GAO), Testimony Before the Committee on Environment and Public Works, U.S. Senate - CHEMICAL REGULATION: Observations on Improving the Toxic Substances Control Act, October 2009 (PDF file):
  EPA lacks adequate scientific information on the toxicity of many chemicals. One major reason is that TSCA generally places the burden of obtaining data about existing chemicals on EPA rather than on chemical companies. For example, the act requires EPA to demonstrate certain health or environmental risks before it can require companies to further test their chemicals. As a result, EPA does not routinely assess the risks of the over 83,000 chemicals already in use. Moreover, TSCA does not require chemical companies to test the approximately 700 new chemicals introduced into commerce each year for toxicity, and companies generally do not voluntarily perform such testing. Furthermore, the procedures EPA must follow to obtain test data from companies can take years.

References

• US EPA: Summary of the Toxic Substances Control Act

• US Senate: PDF of TSCA

• Wikipedia: Toxic Substances Control Act

• Lowell Center for Sustainable Production: The Chemicals Policy and Science Initiative , US Federal Chemicals Policy, Toxic Substances Control Act [accessed June 28, 2010]

• Science and Environmental Health Network: Introduction to TSCA (two-page PDF document), April 2006

• US Government Accountability Office (GAO): Testimony Before the Committee on Environment and Public Works, U.S. Senate - CHEMICAL REGULATION: Observations on Improving the Toxic Substances Control Act, October 2009

Additional Resources

• US EPA: Essential Principles for Reform of Chemicals Management Legislation

• Public Broadcasting Service (PBS): Swimming in Chemicals, excerpt from the book Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power by Mark Schapiro (Chelsea Green Publishing, 2009)

• Wilson MP, Schwarzman MR 2009. "Toward a New U.S. Chemicals Policy: Rebuilding the Foundation to Advance New Science, Green Chemistry, and Environmental Health." Environ Health Perspect 117:1202-1209.

• Safer Chemicals Healthy Families Campaign: A Platform for Reform of the Toxic Substances Control Act

• Environmental Defense Fund: I Am Not a Guinea Pig campaign, Flaws of the Toxic Substances Control Act

• Lowell Center for Sustainable Production: The Chemicals Policy and Science Initiative Comprehensive information on global, regional, and national chemical policies, with numerous links to publications on chemical policy by government agencies and nonprofit organizations.
• Physicians Committee for Responsible Medicine: 21st Century Chemical Regulation