Toxic Substances Control Act of 1976
Encyclopedia
The Toxic Substances Control Act (TSCA) is a United States
law, passed by the United States Congress
in 1976, that regulates the introduction of new or already existing chemicals. It grandfathered most existing chemicals, in contrast to the Registration, Evaluation and Authorization of Chemicals (REACH) legislation of the European Union
. However, as explained below, the TSCA specifically regulates polychlorinated biphenyl
(PCB) products.
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 Cosmetic Act
and the Federal Insecticide, Fungicide, and Rodenticide Act
.
New chemical 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 outright banning them.
(PCB) products.
Subchapter II of the TSCA, "Asbestos Hazard Emergency Response," was enacted by the U.S. Congress in 1986 under PL 99-519 and amended in 1990 under PL 101-637. It authorizes the EPA to impose requirements for asbestos
abatement in schools and requires accreditation of those who inspect for asbestos-containing materials.
Subchapter III of the TSCA, "Indoor Radon Abatement," was enacted by the U.S. Congress in 1988 under PL 100-551. It requires the EPA to publish a guide about radon
health risks and to perform studies of radon levels in schools and federal buildings.
Subchapter IV of the TSCA, "Lead Exposure Reduction," was enacted by the U.S. Congress in 1992 under PL 102-550. It requires the EPA to identify sources of lead
contamination in the environment to regulate amounts of lead allowed in products, including paint and toys, and to establish state programs that monitor and reduce lead exposures.
U.S. regulations implementing the TSCA are in 40 CFR 195, for radon, and in 40 CFR 700-766, for other matters.
Under 15 USC 2605(e) the TSCA specifically regulates PCBs. Subsection (2)(A) provides that after January 1, 1978, "no person may manufacture, process or distribute in commerce or use any polychlorinated biphenyl
in any manner other than in a totally enclosed manner." This section of the TSCA also authorizes the EPA to regulate disposal of PCBs.
Acting under the TSCA and other laws, the EPA has published regulations for PCB disposal and set limits for PCB contamination of the environment. It has engaged in protracted negotiations with the U.S. General Electric
company and other firms for remediation of sites contaminated with PCBs such as the upper Hudson River
.
The EPA has had only limited success controlling the chemicals they have tested and deemed dangerous to the public health. In fact, the agency has been successful in restricting only five chemicals (PCBs, chlorofluorocarbons, dioxin, asbestos, and hexavalent chromium) in its 35 year history, and the ban on asbestos was overturned in 1991.
Many environmental groups, such as Natural Resources Defense Council, complain that the EPA is nearly powerless to take regulatory action against dangerous chemicals, even those known to cause cancer or other serious health effects.
For additional information on TSCA, see NTIS.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
law, passed by the United States Congress
United States Congress
The United States Congress is the bicameral legislature of the federal government of the United States, consisting of the Senate and the House of Representatives. The Congress meets in the United States Capitol in Washington, D.C....
in 1976, that regulates the introduction of new or already existing chemicals. It grandfathered most existing chemicals, in contrast to the Registration, Evaluation and Authorization of Chemicals (REACH) legislation of the European Union
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
. However, as explained below, the TSCA specifically regulates polychlorinated biphenyl
Polychlorinated biphenyl
Polychlorinated biphenyls are a class of organic compounds with 2 to 10 chlorine atoms attached to biphenyl, which is a molecule composed of two benzene rings. The chemical formula for PCBs is C12H10-xClx...
(PCB) products.
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 Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
and the Federal Insecticide, Fungicide, and Rodenticide Act
Federal Insecticide, Fungicide, and Rodenticide Act
The Federal Insecticide, Fungicide, and Rodenticide Act , et seq. is a United States federal law that set up the basic U.S. system of pesticide regulation to protect applicators, consumers, and the environment. It is administered by the Environmental Protection Agency and the appropriate...
.
New chemical 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 outright banning them.
Sections of TSCA
The TSCA is found in United States law at 15 USC (C. 53) 2601-2692. It is administered by the EPA. Subchapter I of the TSCA, "Control of Toxic Substances," is the original substance of the 1976 act, PL 94-469, including regulation of polychlorinated biphenylPolychlorinated biphenyl
Polychlorinated biphenyls are a class of organic compounds with 2 to 10 chlorine atoms attached to biphenyl, which is a molecule composed of two benzene rings. The chemical formula for PCBs is C12H10-xClx...
(PCB) products.
Subchapter II of the TSCA, "Asbestos Hazard Emergency Response," was enacted by the U.S. Congress in 1986 under PL 99-519 and amended in 1990 under PL 101-637. It authorizes the EPA to impose requirements for asbestos
Asbestos
Asbestos is a set of six naturally occurring silicate minerals used commercially for their desirable physical properties. They all have in common their eponymous, asbestiform habit: long, thin fibrous crystals...
abatement in schools and requires accreditation of those who inspect for asbestos-containing materials.
Subchapter III of the TSCA, "Indoor Radon Abatement," was enacted by the U.S. Congress in 1988 under PL 100-551. It requires the EPA to publish a guide about radon
Radon
Radon is a chemical element with symbol Rn and atomic number 86. It is a radioactive, colorless, odorless, tasteless noble gas, occurring naturally as the decay product of uranium or thorium. Its most stable isotope, 222Rn, has a half-life of 3.8 days...
health risks and to perform studies of radon levels in schools and federal buildings.
Subchapter IV of the TSCA, "Lead Exposure Reduction," was enacted by the U.S. Congress in 1992 under PL 102-550. It requires the EPA to identify sources of lead
Lead
Lead is a main-group element in the carbon group with the symbol Pb and atomic number 82. Lead is a soft, malleable poor metal. It is also counted as one of the heavy metals. Metallic lead has a bluish-white color after being freshly cut, but it soon tarnishes to a dull grayish color when exposed...
contamination in the environment to regulate amounts of lead allowed in products, including paint and toys, and to establish state programs that monitor and reduce lead exposures.
U.S. regulations implementing the TSCA are in 40 CFR 195, for radon, and in 40 CFR 700-766, for other matters.
Under 15 USC 2605(e) the TSCA specifically regulates PCBs. Subsection (2)(A) provides that after January 1, 1978, "no person may manufacture, process or distribute in commerce or use any polychlorinated biphenyl
Polychlorinated biphenyl
Polychlorinated biphenyls are a class of organic compounds with 2 to 10 chlorine atoms attached to biphenyl, which is a molecule composed of two benzene rings. The chemical formula for PCBs is C12H10-xClx...
in any manner other than in a totally enclosed manner." This section of the TSCA also authorizes the EPA to regulate disposal of PCBs.
Acting under the TSCA and other laws, the EPA has published regulations for PCB disposal and set limits for PCB contamination of the environment. It has engaged in protracted negotiations with the U.S. General Electric
General Electric
General Electric Company , or GE, is an American multinational conglomerate corporation incorporated in Schenectady, New York and headquartered in Fairfield, Connecticut, United States...
company and other firms for remediation of sites contaminated with PCBs such as the upper Hudson River
Hudson River
The Hudson is a river that flows from north to south through eastern New York. The highest official source is at Lake Tear of the Clouds, on the slopes of Mount Marcy in the Adirondack Mountains. The river itself officially begins in Henderson Lake in Newcomb, New York...
.
TSCA and the EPA
The Toxic Substances Control Act of 1976 mandated the EPA to protect the public from "unreasonable risk of injury to health or the environment" by regulating the manufacture and sale of chemicals. This act does not address wastes produced as byproducts of manufacturing, as did the Clean Water and Air Acts of the era. Instead, this act attempted to exert direct government control over which types of chemicals could and could not be used in actual use and production. For example, the use of chlorofluorocarbons in manufacturing is now strictly prohibited in all manufacturing processes in the United States, even if no chlorofluorocarbons are released into the atmosphere as a result. The types of chemicals regulated by the act fall into two broad categories: existing and new. New chemicals were defined as “any chemical substance which is not included in the chemical substance list compiled and published under [TSCA] section 8(b).” This list included all of chemical substances manufactured or imported into the United States prior to December 1979. This existing chemical list covered 99% of the EPA's mandate in this bill, including some 8,800 chemicals imported or produced at quantities above 10,000 pounds. Existing chemicals include any chemical currently listed under section 8(b). The distinction between existing and new chemicals is necessary as the act regulates each category of chemicals in different ways.Regulation of Existing Chemicals
Though tasked with protecting the public from dangerous and potentially carcinogenic substances, some 62,000 chemicals were never tested by the EPA because they were not considered an "unreasonable risk." This gap in testing effectively grandfathered these chemicals into the TSCAs existing chemicals list. Testing and research on these chemicals is virtually non-existent, with only 200 of the more than 60,000 existing chemicals tested directly by the EPA.The EPA has had only limited success controlling the chemicals they have tested and deemed dangerous to the public health. In fact, the agency has been successful in restricting only five chemicals (PCBs, chlorofluorocarbons, dioxin, asbestos, and hexavalent chromium) in its 35 year history, and the ban on asbestos was overturned in 1991.
Many environmental groups, such as Natural Resources Defense Council, complain that the EPA is nearly powerless to take regulatory action against dangerous chemicals, even those known to cause cancer or other serious health effects.
Regulation of New Chemicals
The EPA has a better record when regulating newly created chemicals. Companies must first notify the EPA of their intention to manufacture a new chemical not listed in the 1976 act by using a Pre-Manufacturing Notice (PMN.) No safety information is required to be included in the PMN, so the EPA must rely on computer modeling to determine whether the new chemical "may prevent an unreasonable risk." If the EPA does not act to block manufacture of the new chemical within ninety days, or the EPA passes the product, the chemical may be legally marketed. The lack of safety data from the PMNs has not led to a lack of regulation for new chemicals, and only 50% of new chemicals pass EPA testing procedures.Criticisms of the TSCA
The EPA's use of the TSCA to regulate dangerous chemicals is seen as a failure by many, including the EPA's Office of the Inspector General, who called the bill "inconsistent and presents a minimal presence." in a report dated February 17, 2010. The agency also criticized the process bywhich the EPA handles new TSCA cases in the same report, claiming it is "predisposed to protect industry information rather than to provide public access to health and safety studies." The report further acknowledges that trade secrets are preventing effective testing. Sometimes the EPA does not even know what chemical the TSCA application refers to, and cannot report any problems because "health and safety data are of limited value if the chemical the data pertain to is unknown." Other groups concerned with the bill's lack of efficacy include the Physicians for Social Responsibility, the U.S. Public Interest Research Group, the Environmental Defense Fund, and the Lung Cancer Alliance, representing more than 11 million people nationwide. These diverse groups, under the umbrella of the National Resources Defense Council plan to lobby Congress to revamp and rewrite the TSCA and allow the EPA to completely phase out and/or ban the most dangerous chemicals on the TSCA list. The group is also calling for greater oversight and reporting of health hazards of chemicals contained in everyday products. Many businesses would also like to see a stronger bill to replace the TSCA, due to the more than 40 different state government regulations on toxic chemicals. In addition, businesses would like a standard that can be applied uniformly, rather than having to report many different sets of requirements to the individual states where the companies do business.For additional information on TSCA, see NTIS.
See also
- Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) - EU legislation)
- Dangerous Substances Directive (67/548/EEC) - EU legislation
- Chemical Facility Anti-Terrorism StandardsChemical Facility Anti-Terrorism StandardsThe Chemical Facility Anti-Terrorism Standards , also known as 6 CFR, Part 27, are a set of US government security regulations for high-risk chemical facilities such as chemical plants, electrical generating facilities, refineries, and universities. The US Department of Homeland Security...
(CFATS) - Homeland security laws for chemical storage - EPA Makes Chemical Information More Accessible to Public For the first time, TSCA chemical inventory free of charge online (March 15, 2010)