The Toxic Substances Control Act (TSCA) is a United States law, passed by the Congress in 1976 and administered by the United States Environmental Protection Agency (EPA), that regulates chemicals not regulated by other U.S. federal statutes, including chemicals already in commerce and the introduction of new chemicals. When the TSCA was put into place, industry had an opportunity to submit chemicals that were existing in commerce at that time. Such chemicals became the original TSCA Inventory, allowing each to remain commerce without EPA review. Its three main objectives are to assess and regulate new commercial chemicals before they enter the market, to regulate chemicals already existing in 1976 that posed an "unreasonable risk of injury to health or the environment", as for example PCBs, lead, mercury and radon, and to regulate these chemicals' distribution and use.
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 listed on the TSCA Inventory or subject to one of many exemptions. Chemicals listed on the inventory are referred to as "existing chemicals", while chemicals not listed are referred to as new chemicals. The act 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" although TSCA excludes chemicals regulated by other federal statutes from the definition of a chemical substance.
Generally, manufacturers must submit premanufacturing notification to EPA prior to manufacturing or importing new chemicals for commerce. Exceptions include foods, food additives, drugs, cosmetics or devices regulated under the Federal Food, Drug, and Cosmetic Act, pesticides regulated by the Federal Insecticide, Fungicide, and Rodenticide Act, tobacco and tobacco products regulated by the Bureau of Alcohol, Tobacco, Firearms and Explosives, substances used only in small quantities for research and development under Section 5(h)(3), and radioactive materials and wastes regulated by the Nuclear Regulatory Commission. EPA reviews new chemical notifications and if it finds an "unreasonable risk of injury to health or the environment", it may regulate the substance from limiting uses or production volume to outright banning it. In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was the first major overhaul in many years.
Overview
The Toxic Substances Control Act of 1976 mandated EPA to protect the public from "unreasonable risk of injury to health or the environment" by regulating the manufacture (including import), processing, distribution, use, sale, and disposal of chemicals. This act does not address pollution, which is regulated through the Clean Air Act, Clean Water Act and the Resource Conservation and Recovery Act. Instead, like FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act), TSCA regulates commercial products. The act gave EPA the authority to gather information on and require manufacturers (and importers) to test products, required EPA to create a listing of existing chemicals and the industry to notify EPA of new chemicals being produced, and gave EPA the ability to regulate chemical production and use. For example, in 2019 EPA banned the use of methylene chloride in consumer paint and coating removal products.
The types of chemicals regulated by the act fall into two broad categories: existing and new. The distinction is made because the act regulates the two categories of chemicals in different ways. Existing chemicals include any chemical currently listed on the TSCA Inventory under TSCA section 8(b). "[A]ny chemical that is not [listed] on the [TSCA] Inventory is considered a 'new chemical substance.'" The Inventory includes all chemical substances manufactured or imported into the United States for a non-exempt purpose.
Sections
The TSCA is found in United States law at Title 15 of the United States Code, Chapter 53, and administered by EPA.
- Title I of the TSCA, "Control of Toxic Substances", is the original substance of the 1976 act, establishes the core programs, including regulation of new and existing chemicals, testing, and reporting.
Key sections include:
- Section 3 - Definitions
- Section 4 - Testing
- Section 5 - New Chemicals
- Section 6 - Existing Chemicals
- Section 7 - Imminent Hazards
- Section 8 - Recordkeeping and Reporting
- Section 11 - Inspections
- Section 12 - Exports
- Section 13 - Imports
- Section 14 - Confidential Business Information
- Section 15 - Prohibited Acts
- Section 18 - Preemption
- Section 20 - Citizen Suits
- Section 21 - Citizen Petitions
- Section 26 - Administration of TSCA
- Title II, "Asbestos Hazard Emergency Response", authorizes EPA to set standards for asbestos abatement in schools, and requires asbestos contractors to be trained and certified, enacted in 1986 under PL 99-519 and amended in 1990 under PL 101-637.
- Title III, "Indoor Radon Abatement", requires EPA to publish a guide about radon health risks and to perform studies of radon levels in schools and federal buildings, enacted in 1988 under PL 100-551.
- Title IV, "Lead Exposure Reduction" requires 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, enacted in 1992 under PL 102-550.
U.S. regulations implementing the TSCA are in 40 CFR Part 195 for radon, and in 40 CFR Parts 700 through 799 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 PCB in any manner other than in a totally enclosed manner." It also authorizes EPA to regulate PCBs disposal.
Acting under the TSCA and other laws, EPA has 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.
History
The TSCA was passed by the Congress and signed into law by President Gerald Ford on October 11, 1976 after years of negotiation between the government and chemical producers. A bill was first introduced in Congress in 1971, but it was opposed by industry and environmental groups, leading to a five-year stalemate. TSCA authorized the EPA to regulate new and existing chemicals. TSCA was in response to Congress' growing concerns about the unreasonable risks that chemicals pose to human health and the environment. TSCA limits the manufacture, processing, commercial distribution, use, and disposal of chemical substances including PCBs, asbestos, radon and lead-based paint.
The 1971 Council on Environmental Quality Report
In a 1971 report, the Council on Environmental Quality (CEQ) urged the Federal government to regulate toxic substances in the U.S. CEQ explained that existing regulations were insufficient to protect human health and the environment. For example, the existing law only took effect after the damages were done and did nothing to prevent future damage. As John R. Quarles Jr., the EPA Deputy Administrator, later explained during congressional testimony in 1975, "While some authority exists to control the production of certain categories of toxic substances, such as pesticides, drugs, and food additives, most existing Federal authorities are designed to prevent harmful exposure only after the substances have been introduced into production." In order to adequately regulate what chemicals should enter the environment, CEQ recommended that the government create a more comprehensive chemical policy to identify and control the chemicals that are manufactured, produced, and used in the U.S economy. Specifically, CEQ recommended that TSCA strengthen government oversight by requiring the following measures: First, manufacturers should notify officials when they use or produce new chemicals, or plan to sell a significant volume of old chemicals. Second, producers should test their chemicals and report data to officials on the quantities, uses, physical and biological properties, and any other information is necessary for assessing hazardous materials. Lastly, with this information, the government should disclose any information about the health effects caused by dangerous chemicals to the public.
Congress' response to CEQ and the drafting of TSCA
Congress agreed with CEQ that additional authority was required to test chemicals to determine their effect, and responded to CEQ's recommendation by proposing many House and Senate bills between 1972 and 1973. Policy makers were also aware that the cancer mortality rate had increased and recognized that the cause of the increase was related to the rise of industrial chemicals in consumer products and the environment. As a result of these concerns, Congress concluded the risk of chemical exposure to the public were serious enough to warrant swift legislative action.
Three key assumptions informed Congress' approach to drafting a chemicals control policy. First, in order to limit the risks that chemicals pose to human health and the environment, it would be important to be proactive in understanding toxic substances and use preventive measures. Second, toxic risk should be approached in a "holistic rather than fragmented" manner. Third, it was important to collect as much information as possible about the toxicity of chemicals and the risks associated with them.
Although there was much support for policy to address public health risks from chemical exposure, the law was stalled at the last minute because of disagreement over the proper scope of chemical screening prior to commercial production. However, a series of environmental disasters, such as the Kepone catastrophe at Hopewell, Virginia, and the pollution of the Hudson River "and other waterways by PCBs, the threat of stratospheric ozone depletion from chlorofluorocarbon (CFC) emissions, and contamination of agricultural products by polybrominated biphenyls (PBBs) in the State of Michigan" provided a clearer picture of the costs of weak regulation over toxic substances. Subsequently, the legislation passed in 1976.
Congress designed TSCA to empower EPA to collect more information on chemicals and their potential dangerous effect on human health and the environment. As a result, TSCA's jurisdictional scope is extremely broad. Congress's definition of chemical substances includes "any organic or inorganic substance of a particular molecular identity", and "any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature" as well as "any element or uncombined radical". These chemicals are found in children's products (e.g., toys) cleaning products, furniture, electronics, building materials, and car interiors. The law attempts to oversee the manufacture (including import), processing, distribution, use and or disposal of such chemical substances. Prior to the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA directed the EPA to use the least burdensome method to reduce chemical risk to reasonable levels while taking into consideration the benefits provided by the chemical product or process.
Implementation
There have been many challenges in the implementation of TSCA. First, according to David Markell, Professor of Law at Florida State University, TSCA and preexisting regulations have "an after-the-fact focus" that fails to protect individuals before toxic substances are released in products and is media focused without addressing how to control pollution within communities.
Second, TSCA implementation is difficult because of the number of chemicals in the US market and high costs associated with fully assessing the toxic impacts of so many chemicals on human health and the environment. 62,000 chemicals on the market at the time were listed on the original TSCA Inventory of Chemical Substances. TSCA "grandfathered" these 62,000 chemicals, allowing these substances to remain on the market without first assessing toxic impacts. New chemicals, however, would be subject to review for health and environmental risks. Since then number of chemicals listed on the TSCA Inventory has grown to roughly 84,000. The EPA has only required approximately 200 of these 84,000 chemicals to be tested, and of the 22,000 chemicals introduced since 1976, chemical manufacturers have produced very little data for the EPA on potential health and/or environmental impacts.
Third, even though, prior to 2016, TSCA gave authority to the EPA to require testing chemicals through rule making process, EPA had difficulty obtaining the data needed to determine their risks. It was difficult to collect information from industries about the risks of chemicals and EPA has concluded that conducting its own testing is too costly. EPA is authorized to require industry to perform testing of chemicals being produced in substantial quantities or if EPA finds that the manufacturing, production or use of a chemical "may present an unreasonable risk of injury to health or the environment."
The only information required from chemical producers is chemical identities, names, and molecular structures, categories of use, amount 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.
In order to obtain more information related to chemical risks, the EPA may require manufacturers to conduct testing. This occurs either by (1) mutual agreement, (2) voluntary industry efforts, such as those under the HPV Challenge Program, (3) by rule, or (4) by order. The EPA has also created the Sustainable Futures (SF) Initiative model, which allows companies to voluntarily screen their products that might pose risks to human health or the environment. Through this initiative, the EPA hopes to enable manufacturers to better predict hazards and exposures of their products. The program is designed to enable companies to bring safer chemicals to the market.