Toxic Substances Control Act of 1976

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 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

thumb|Labeling PCB-containing transformers

thumb|EPA flyer on lead-based paint disclosure

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. 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. 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. As a result, TSCA's jurisdictional scope is extremely broad. 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. 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.

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.

Regulation of existing chemicals

thumb|Existing Chemicals Review process

thumb|Risk evaluation process for existing chemicals

Existing chemicals are those listed in the TSCA Inventory. Also, if a substance is subject of a Significant New Use Rule (SNUR), a company would have to submit and receive approval of a Significant New Use Notice (SNUN) prior to undertaking the significant new use(s) defined in the SNUR.

In 1989, the EPA issued a final rule under section 6 to ban the manufacturing, importing, and processing of nearly all asbestos-containing products in the USA. However, it had only limited success in using the authority granted under TSCA section 6 to control chemicals tested and deemed dangerous to public health. with the ban on asbestos being partially overturned in 1991. EPA has restricting some existing chemicals using Section 5 SNURs.

, 250 of the more than 60,000 existing chemicals have been subject to required tested by the EPA. 140 of those chemicals were tested by regulatory order and 60 were tested after voluntary consent by the manufacturer. The HPV program lead to the generation of new or release of existing data on over 2,200 chemicals.

Regulation of new chemicals

thumb|Status chart of new chemicals being reviewed by EPA, November 1, 2022

Companies must notify the EPA of their intention to manufacture (or import) a new chemical (one not listed on the TSCA Inventory) by submitting a PMN at least 90 days prior to the first manufacture or import for a non-exempt purpose. Section 5 of TSCA does not require any toxicity testing before submitting a PMN. If data on the substance are not available, EPA relies on data on analogs or models to evaluate whether the substance "may present an unreasonable risk." In order to regulate new chemicals, the EPA must determine that the chemical "...may present an unreasonable risk of injury to health or the environment..." or show that the chemical "... is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance...." The non-confidential inventory, which includes the specific identity of non-confidential substances and a generic identity for confidential substances, is provided in Microsoft Access and CSV formats within ZIP files.

It is critical to understand TSCA nomenclature rules to determine if a particular chemical product is listed on the Inventory.

Inventory notification reporting is through an updated user interface in the Central Data Exchange (CDX) Chemical Safety and Pesticide Programs (CSPP) web application for company-authorized officials and their support; there is no role for the public to access the CDX CSPP web app. Data submitted to EPA under the quadriennial Chemical Data Reporting Rule is published by EPA on its ChemView website and as a downloadable database.

The Toxics Release Inventory (TRI) is a different inventory for Superfund reporting.

Testing

Prior to 2016, EPA had the authority to require manufacturers to test existing chemicals under Section 4, but in each case the EPA had to undertake formal notice-and-comment rule-making which is subject to judicial review under the "substantial evidence" standard. including some undergoing risk evaluation under Section 6 and some per- and polyfluoroalkyl substances.

Criticism

TSCA had been severely criticized by non-governmental organizations, academics, scientists, and even government agencies for failing to regulate the safe use of chemicals affecting human health and environmental welfare effectively. Prior to the TSCA amendments in 2016, "the act has not been substantially updated." Organizations concerned about product safety, "including the chemical industry, environmental and public health advocates, and the EPA" The report criticized the process by which the EPA handles new TSCA cases, claiming it is "predisposed to protect industry information rather than to provide public access to health and safety studies." for stricter control on toxic chemicals as a response to the failure of Congress to modernize TSCA. In states such as California, Connecticut, and Michigan diverse chemical policy actions were introduced favoring tighter regulation to protect vulnerable populations and the environment from exposure to dangerous chemicals. Moreover, state law initiatives and rules to target chemicals have significant support from "the public demanding stricter chemical control." The modernization of TSCA can give the chemical industry a standard to follow and allow them to market their products for domestic consumption or international sales without having to spend more money trying to comply with a myriad of individual state regulations.

Consumer support for the reform of TSCA

Growing public concern about exposure to dangerous chemicals in their everyday life has received attention from state and local agencies. For better management and control of chemicals "a string of high-profile campaigns focusing on chemicals in consumer products" According to the Safer Chemicals, Healthy Families Coalition, "18 states have collectively passed 71 chemical laws since 2003." Similarly, the state of California implemented the California Green Chemistry Initiative (CGCI) in an effort to increase innovation and reduce or eliminate hazardous substances to human health and the environment. The CGCI responds to the demand by consumers and environmental groups advocating for greener products.

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. The regulation of nano particles is another challenge for TSCA, "there are no specific regulations on nanoparticles except existing regulations covering the same material in bulk form."

There is not enough knowledge about the potential risk of exposure while new nano material created at a rapid rate is incorporated into consumer products without testing the toxicity risk of exposure to human health and the environment. Technological creation of new chemicals is ahead of TSCA regulation for new chemicals. The U.S. chemical industry claims having tight regulations can interfere with their ability to compete.

TSCA and environmental justice

TSCA can promote environmental justice in communities where minorities and low-income residents disproportionately bear great exposure to toxic chemicals increasing their risk to suffer from "chronic diseases and conditions such as prostate cancer, learning disabilities, asthma, infertility, and obesity." associated with industrial facilities built near low-income neighborhoods. Communities from minority groups are disproportionately affected by "environmental threats from toxic contamination, locally unwanted land use (LULUs) to unsafe and substandard housing and natural-resource extractions" cannot wait for years until bureaucratic processes demonstrate their health has been at risk from living under these conditions.

Studies have shown that "lower-income people were found to be significantly more likely than were higher income people to live near a polluting industrial facility." This concern is reflected in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which includes a requirement that EPA evaluate risk to "potentially exposed and susceptible subpopulations".

Children's exposure to toxic chemicals

Children are more susceptible to develop patterns of illness with longtime effect in their health for which chemical exposure can be contributing pediatric disease. The main health problems associated with environmental chemical pollutants are asthma, lead poisoning and obesity. It is estimated that "the annual costs of environmentally attributable diseases in American children due to lead poisoning amounts to $43.4 billion." Toxic chemicals "threaten the health of the developing fetus, babies, young children and teens." Communities living near hot spots present health problems "associated with both social and environmental stressors", this can put a disproportionately burden on families. Therefore, "information on potential toxicity" can help parents to make better decisions about the products they purchase for the use of the children. Information about the toxicity is only available for about "two-thirds of the 3000 high production volume (HPV) chemicals".

In January 2016, the Center for Science in the Public Interest released a report entitled Seeing Red - Time for Action on Food Dyes which criticized the continued use of artificial food coloring in the United States. The report estimated that over half a million children in the United States suffer adverse behavioral reactions as a result of ingesting food dyes, with an estimated cost exceeding $5 billion per year, citing data from by the Centers for Disease Control and Prevention. The report urges the Food and Drug Administration to take action to ban or curtail the use of such dyes. Readers are reminded that baby bottles and artificial food coloring are not regulated under TSCA jurisdiction, rather they are regulated under the Federal Food, Drug, and Cosmetic Act. However, other toxic substances that may be found in baby food (e.g., bisphenol A), are under TSCA jurisdiction.

Pregnant women's exposure to chemicals

Pregnant women exposure to toxic chemicals in daily basis "can impact the reproductive and developmental health" during critical windows of development, this may lead to a higher risk for birth defects and childhood illnesses and "disability across the entire span of human life". Health professionals can provide information to women planning to become pregnant or already pregnant to avoid potential hazards and exposure to environmental toxic chemicals. Eating healthy food can reduce the impact of toxic chemicals, for instance consuming organic food. Mothers who are breastfeeding can expose their child to toxic chemicals in their milk. When the diet of children is modified from "conventional to organic food, the levels of pesticides in their bodies decline", but low-income families have to prioritize their needs and buying organic food may not be possible because of a budget constraint Readers are reminded that pesticides are not regulated under TSCA jurisdiction, rather they are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act. However, other toxic substances that can be transmitted through breast milk (e.g., per- and polyfluoroalkyl substances (PFAS)) are under TSCA jurisdiction.

Occupational workers' exposure to toxic chemicals

According to the Occupational Safety & Health Administration (OSHA) workers have the right to a safe workplace that do not pose a risk of serious harm. Occupational exposure to chemicals can happen through direct skin contact, inhalation, ingestion or eye contact. People working under certain occupations are more exposed to toxic chemicals that can have a negative longtime effect in their health. If the rate of exposure exceeds the capacity of the body to detoxify and eliminate them, it can accumulate in the body and potentially harm it. Male and female fertility can be compromised from exposure to toxic chemicals. Concerns for exposure to workers is reflected in the explicit inclusion of workers with the definition of "potentially exposed and susceptible subpopulations" in the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Corporate support for mitigation of toxic chemical exposure

Corporations can show social responsibility by removing products from the market and introducing similar alternatives that can benefit vulnerable groups. For instance, "Kaiser Permanente, a major medical supply purchaser, has a policy to avoid chemicals associated with cancer, reproductive problems and genetic mutations." Corporation social responsibility (CSR) is the moral obligation of the firm "to create success in ways that honors ethical values and respect to communities while promoting sustainability and a good reputation." Corporations can innovate and improve their image by responding to the increasing demand of green chemicals by consumers seeking better options to reduce their exposure to toxic chemicals.

Reform bills

Prior to 2015

On May 23, 2013, Senators David Vitter (R-LA) and Frank Lautenberg (D-NJ), introduced a TSCA reform bill, co-sponsored by a number of other senators at the United States House Energy Subcommittee on Environment and Economy. The main focus of this effort was to amend TSCA's subsection S.1009, the Chemical Safety Improvement Act (CSIA). The Environmental Defense Fund felt it would have given the EPA many critical tools to strengthen the provisions on public health protection and improved TSCA.

The bill's key revision included "mandating safety evaluations for all chemicals in active commerce, requiring new chemicals to be deemed likely safe before entering the market, fixing the key flaws in TSCA's safety standard that led to the EPA's inability to ban asbestos, allowing the EPA to order testing without first having to show potential risk, and making more information about chemicals available to states, health professionals and the public by limiting current trade secret allowances." On February 4, 2014, the Senate Committee on Environment and Public Works held hearings on the CSIA right after the incident.

The CSIA was 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.

2015

In March 2015, Senator Tom Udall (D, NM) sponsored Senate bill 697, to amend and reauthorize TSCA, called the "Frank R. Lautenberg Chemical Safety for the 21st Century Act". Environmental, health and labor organizations and several states criticized it, because "it would gut state chemical regulations", but officials from the EPA and Administrator Gina McCarthy have testified that the bill meets all of the Obama Administration's principles for TSCA reform and that the Administrator was "encouraged" by the bipartisan progress. Senate bill 725, introduced by Senator Barbara Boxer (D-CA) and Senator Edward Markey (D-MA), also called the "Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act", would enable the EPA to quickly assess the safety of more chemicals and allow new state policies.

On January 20, 2016, Gina McCarthy, the EPA Administrator, sent a letter to Congress detailing the EPA's positions on S. 697 and H.R. 2576. The letter points out support and concern for a number of topics related to TSCA reform, including: Deadlines for action, elimination of the "least burdensome" requirement for Section 6 regulation, a sustained source of funding, existing chemical review prioritization, consistent applicability of a new TSCA safety standard for both new and existing chemicals, transparency and confidential business information, chemicals contained in articles, and state preemption.

Congress passed a reconciled version of the reform bill, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, with bipartisan support in early June 2016. On Wednesday, June 22, 2016, President Barack Obama signed the bill into law, remarking that "even in the current polarized political process here in Washington, things can work." Lawmakers and industry groups were largely supportive of the new law, while environmental advocates offered more mixed reactions.

Comparison with EU chemical regulation

The European Union (EU) enacted similar laws called Registration, Evaluation and Authorization of Chemicals (REACH) on June 1, 2007, to improve the former legislative framework on chemicals.

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

REACH vs. TSCA requirements on developing chemical information

Developing 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 . In TSCA's section 5, companies are required to submit such data if the effect already exists when they submit a premanufacture notice (PMN) to the EPA. Consequently, and according to information dating from the 1980s, slightly less than 50% of new chemicals submitted for evaluation by the EPA are accompanied by toxicity data, which mainly consists of local irritation (skin and eyes) or acute toxicity tests in laboratory animals. 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 the EPA. The EPA compares 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 (ECHA) regulations, chemical companies are required to provide quantities of chemicals, and depending on the quantity, the companies need to further develop data on human health and environment for both existing and new chemicals. 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. For 100 or more tonnage annually, bioaccumulation, simulation testing, identification of degradation data, long-term toxicity to fish and aquatic species, short-term toxicity to terrestrial organisms and plants, two-generation toxicity study, subchronic toxicity to mammals data are required.

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 the companies to search for safer alternatives. Unlike TSCA, REACH can share the firm's chemical information with state, government authorities and EU organizations under an agreement between the firm and the other responsible parties.

References

Guide to the Toxic Substances Control Act (TSCA). Bergeson & Campbell, P.C., Bergeson, Lynn L., Gold, Miriam V., Warshaw, Jean (2025) Lexis Nexis, ISBN 979-8-3417-1088-7.
EPA. "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.

External links

15 USC chapter 53 of the United States Code from the LII
15 USC chapter 53 of the United States Code from the US House of Representatives
Toxic Substances Control Act as amended (PDF/details) in the GPO Statute Compilations collection
40 CFR chapter I → subchapter R (parts 700–799) in the Code of Federal Regulations
TSCA chemicals from the EPA
TSCA summary from the EPA