Toxic Substances Control Act of 1976

Toxic Substances Control Act

Long title	An Act to regulate commerce and protect human health and the environment by requiring testing and necessary use restrictions on certain chemical substances, and for other purposes.
Acronyms (colloquial)	TSCA
Enacted by	the 94th United States Congress
Effective	October 11, 1976
Citations
Public law	94-469
Statutes at Large	90 Stat. 2003
Codification
Titles amended	15 U.S.C.: Commerce and Trade
U.S.C. sections created	Chapter 53 §§ 2601–2629
Legislative history
Introduced in the Senate as S. 3149 by Sen. John V. Tunney (D–CA) on March 16, 1976 Passed the Senate on March 26, 1976 (60-13) Passed the House of Representatives on July 23, 1976  Reported by the joint conference committee on August 23, 1976; agreed to by the House of Representatives on September 28, 1976 (360-35) and by the Senate on September 28, 1976 (73-6) Signed into law by President Gerald Ford on October 11, 1976
Major amendments
P.L. 99-519 (1986); P.L. 100-551 (1988); P.L. 101-637 (1990); P.L. 102-550 (1992)

The Toxic Substances Control Act (TSCA) is a United States law, passed by the United States Congress in 1976 an administered by the United States Environmental Protection Agency, that regulates the introduction of new or already existing chemicals. When the TSCA was put into place, all existing chemicals were considered to be safe for use and subsequently grandfathered in. This action contrasts the Registration, Evaluation and Authorization of Chemicals (REACh) legislation of the European Union. It's three main objectives are to assess and regulate new commercial chemicals before their entrance into the market, to regulate chemicals (which were already existing in 1976) that posed an "unreasonable risk to health or to the environment", and to regulate these chemicals' distribution and use. 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", while chemicals not listed are referred to as new chemicals. The TSCA defines the term 'chemical substance' as "any organic or inorganic substance of a particular molecular identity, including any combination of these substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or uncombined radical". 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 substances used only in small quantities for research and development under Section 5(h)(3), for foods, food additives, drugs, cosmetics or devices regulated under the Federal Food, Drug, and Cosmetic Act, for pesticides regulated by the Federal Insecticide, Fungicide, and Rodenticide Act, for tobacco and tobacco products regulated by the Bureau of Alcohol, Tobacco, Firearms and Explosives, and for radioactive materials and wastes regulated by the Nuclear Regulatory Commission. 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.

Since May 22, 2013, Senate Bill 1009 has been pending in Congress to reform TSCA, entitled the Chemical Safety Improvement Act. This would be the first major overhaul in many years.

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 biphenyl (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.

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.

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 by which 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 TSCA's lack of efficacy include the Physicians for Social Responsibility, the U.S. Public Interest Research Group, the Environmental Defense Fund, the Lung Cancer Alliance and the Asbestos Disease Awareness Organization representing more than 11 million people nationwide. These diverse groups, under the umbrella of the National Resources Defense Council however are displeased with the new draft bill written by deceased Senator Lautenberg in May 2013. The group is calling for greater oversight and reporting of health hazards of chemicals contained in everyday products.

However, chemical manufacturers and their trade associations would prefer a weaker version of TSCA that pre-empts state law, 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.

2013 Reform Bills and Preemption Controversy

In May 2013, efforts to revamp TSCA were introduced in the U.S. Senate. Senate Bill 1009, introduced by Senators Vitter (R-LA) and Lautenberg (D-NJ), and co-sponsored by a number of Senators. This would be the first major overhaul of the act in many years.

A number of environmental groups have criticized the TSCA, such as the Environmental Working Group, Earthjustice, and the Environmental Defense Fund, explained below. Furthermore, some environmental and victim's groups are highly critical of the bill as Section 15 contains broad language that may preempt all state personal injury or environmental litigation relating to any chemical listed on the registry.

The Environmental Working Group argues that the CSIA is not a reform that protects the general public's health, but rather pushes the American chemical industry's agenda with a weak safety standard. However, the EWG (Environmental Working Group) regards the CSIA as moving in the right direction because the EPA gains more authority to review existing chemicals and order companies to provide any relevant safety data about a specific chemical in question.

The Environmental Working Group, Earthjustice, and the Environmental Defense Fund criticize the CSIA because it would keep states from putting into place their own regulatory laws and void any laws already in place, something they have been doing in lieu of the failed TSCA. This causes a problem because many states, in absence of a federal law, have set up their own regulations. If the CSIA passes, many of these regulations would become null and void. Furthermore, states would now be required to have the funding and man-power to enforce any and all regulations that the EPA decides on.

There are also no clear timelines or deadlines set in the CSIA with respect to testing chemicals and putting in place regulatory action if needed, new chemicals would still be able to enter the market before the EPA can fully evaluate risk, and there would still be a lack of required basic safety test data for new or existing chemicals.

The CSIA is supported by the National Hispanic Medical Association, the Environmental Defense Fund, the American Academy of Pediatrics, The Humane Society, The New York Times, the Washington Post, the Chicago Tribune, the American Alliance for Innovation, the International Association of Machinists and Aerospace Workers, North America's Building Trades Union, SMART-Transportation Division, International Association of Bridge, Structural, Ornamental and Reinforcing Iron Workers, the American College of Occupational and Environmental Medicine, the International Brotherhood of Electrical Workers, and Third Way .

Chemicals Regulation: A comparison of US and European Approaches

Like the TSCA in the U.S., the European Union (EU) has enabled laws called Registration, Evaluation and Authorization of Chemicals (REACH) on June 1, 2007 to improve the former legislative framework on chemicals. In order to review the approaches of both TSCA and REACH on requiring chemical companies to develop information on chemicals’ effects, controlling risk from chemicals, and making information on chemicals available to the public, the U.S. Government Accountability Office analyzed and compared their applicable regulations, interviewed the officials, industry representatives, and environmental advocacy organizations in both legislations.

There are three main points to emphasize on the comparisons of REACH and TSCA.

REACH vs. TSCA requirements on developing chemical Information

Developing a sufficient information is important for risk management and for prevention from potential hazardous substances. Categories of information that are useful in risk management are first, scientific information including the composition of the chemical, secondly, technological information including monitoring, preventing or controlling, and finally, legal information including the rights and obligations of producers, consumers and general public

TSCA requires chemical companies to submit to EPA any available human health and environmental data that they have on the existing chemicals. TSCA does not require chemical companies to test new chemicals on their effects on human health or the environment and create data. However, companies are required to submit such data if the effect already exists when they submit a premanufacture notice (PMN) to EPA. TSCA also requires data on the physical and chemical properties, fate, health and environmental effects of the chemical (hazard information) that the companies possess or reasonably ascertainable when they submit the intent of manufacturing notice to EPA. EPA compare new and existing chemicals by their molecular structures in order to determine if any health and environmental effects are available.

Under REACH and European Chemicals Agency’s regulations, chemical companies are required to provide quantity of chemicals and depending on the quantity, the companies need to further develop data on human health and environment. REACH has a single system for regulating new and existing chemicals. REACH requires different chemical information depending on their amount produced or imported and toxicity level. For example, at the one or more tonnage, chemical companies are required to register and submit information including chemical identity,production process, instruction of usage, safety guidance, summaries of physical and chemical properties, exposure and effects on human health and environment. At the 10 or more tonnage, the information for one or more tonnage must be included, additionally, chemical safety assessment, a physiochemical hazard, an environmental hazard, and chemical’s persistent, bioaccumulative, and toxic pollutant assessment information are required.

TSCA and REACH regulations on potential chemical risks

Under TSCA, EPA needs to collect data needed to assess the potential risks of chemicals and requires developing substantial evidence in the in order to withstand judicial review and policy making. Due to the section 6(a) of TSCA, EPA has difficulty proving that certain chemicals pose unreasonable risks. In order to regulate those chemicals, EPA must find a reasonable basis to conclude that the chemical presents unreasonable risk of injury to health or the environment. However the section is taken into consideration to modification in the 2013 reform. The Section 6 also limits or restricts the production of polychlorinated biphenyls, fully halogenated chlorofluoroalkanes, dioxin, asbestos, and hexavalent chromium. In addition for 160 existing chemicals, under Section 5a2, TSCA requires chemical companies to submit notices to EPA prior to manufacturing, importing, or processing of the substance for new usage. REACH requires chemical manufacturers, importers, and downstream users to ensure that the chemicals do not negatively affect human health or the environment and they should request authorization to produce or import hazardous chemicals and should look for the companies to search for safer alternatives for the harmful chemicals (. The authorization procedures involves first European Chemicals Agency to publish a candidate list of chemicals, secondly, the European Commission determine the authorizations or exempts from candidate lists, and finally, if a chemical is deemed to require authorization, a chemical company will have to apply to the European Commission for the authorization. If the chemical company can demonstrate that social and economic benefits outweigh the risks, the harmful chemical may be able to get authorization. Likewise TSCA, REACH restricts chemicals that pose an unacceptable risk to health or environment. In order to restrict, REACH must demonstrate the chemical’s risk to human health or the environment that needs to be addressed at the community wide level and identify the most appropriate set of risk reduction measures and safer substitutes.

TSCA vs. REACH Disclosing Chemical Information to the Public

Information disclosure gives an opportunity to the public to immediately react and avoid exposure to potential chemical hazards and risks for example by changing consumer behavior or applying pressure on the chemical firms etc. In the other hand, information disclosure also can motivate firms to search for safer alternatives. Especially, it is important that the state and local environmental agencies, environmental advocates and other public groups in obtaining chemical information in order to develop contingency plans and effective emergency responses in cases of highly toxic exposures. TSCA allows companies to claim their chemical production volumes, components and any information provided to EPA as business confidential except the chemicals for health and safety studies. In this extent of TSCA, EPA’ s ability is restricted to share information including the company’s identities, the chemical’s structures, and site of operation with the state officials or with officials of foreign governments. However, EPA can disclose confidential business information when it determines such disclosure is necessary to protect human health or the environment from an unreasonable risk.

Similar to TSCA, REACH mandates chemical companies to disclosure of health and safety information that allows public to have an access to the basic chemical information, including brief profiles of hazardous properties, authorized uses, and risk management measures. REACH considers the full chemical composition, the preparation, the precise use, the detailed function or application of the chemical, the precise tonnage or volume of the chemical manufactured or placed on the market and the relationships between manufacturers, importers and downstream users as confidential for the industry’s economic purpose. In a case of an immediate threat to human health and safety or to the environment, REACH authorizes the European Chemicals Agency to publicly disclose the confidential information. BPTs (Bioaccumulative and Toxic Substances) and vPvB (Very Persistent and Very Bioaccumulative and Toxic Substances), and other chemicals that are classified as dangerous, REACH requires firms to submit safety data sheet. Therefore the downstream users, manufacturers, retailers and importers will have the information they need to safely use and handle the chemicals. Unlike TSCA, REACH can share the firm’s chemical information with state and government authorities and EU organizations under an agreement between the firm and the other parties involved.

Comparison of TSCA and REACH’s selected provisions

Definition of new and existing chemicals

REACH has a single system for both new and existing chemicals. TSCA: New chemicals are not listed on the TSCA inventory. Existing chemicals are listed in the TSCA Inventory.

Number of chemicals covered in the inventory

REACH: After enacting REACH in European Union, the officials estimated approximately 30,000 cases that have produced or imported at a level of at least 1 metric ton chemicals.

TSCA: Currently more than 82,000 chemicals are in the TSCA inventory and 20,000 of them were added after 1979 into the inventory after the EPA program started reviewing the existing chemicals.

Complete risk assessment requirements

REACH requires chemical companies that produce at level of 1 metric tons per year to conduct risk assessment along with European Chemical Agency’s review and for the companies that produce more than 10 tons or more per years need to conduct chemical safety assessment for all the chemicals produced.

TSCA does not require chemical companies to perform risk assessments on new chemicals. However, it allows companies to perform voluntary risk assessments on their new chemicals. For existing chemicals, companies are required to notify EPA immediately of new unpublished information on chemicals that potentially risky but are not required conduct risk assessments.

Production quantity disclosure

REACH requires chemical companies to submit their registration yearly with the information on the overall quantity of production or importing of a chemical in metric tons per year in a technical dossier and immediately report if any significant changes occur in the quantity. TSCA: Chemical companies must provide EPA a reasonable third year estimate for their new chemicals in total production volume at the time a Premanufacture Notices is submitted. For every 5 years, the existing chemicals on the TSCA inventory and produced at quantities of 25,000 pounds or more must be reported.

Example of chemical inventories in various countries and regions

• Verordnung (EG) Nr. 1907/2006 (REACH)
• AICS - Australian Inventory of Chemical Substances
• DSL - Canadian Domestic Substances List
• NDSL - Canadian Non-Domestic Substances List
• KECL (Korean ECL) - Korean Existing Chemicals List
• ENCS (MITI) - Japanese Existing and New Chemical Substances
• PICCS - Philippine Inventory of Chemicals and Chemical Substances
• TSCA - US Toxic Substances Control Act
• SWISS - Giftliste 1
• SWISS - Inventory of Notified New Substances

See also

• Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) - EU legislation
• Dangerous Substances Directive (67/548/EEC) - EU legislation
• Kashinhou - Japanese legislation
• Chemical Facility Anti-Terrorism Standards (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)

References

Sources

• U.S. Environmental Protection Agency, "Summary of the TSCA law and regulations".
• U.S. Environmental Protection Agency, "Announcement of agreement with General Electric to conduct Hudson River dredging", October 6, 2005.
• Schapiro, Mark, "New Power for 'Old Europe'". The Nation, December 27, 2004, 11-16.

Notes

External links

• Text of Toxic Substances Control Act
• National Technical Information Service