The Toxic Substances Control Act (TSCA) is a United States law created by Congress in 1976 and managed by the U.S. Environmental Protection Agency (EPA). It controls chemicals not already regulated by other U.S. federal laws, including chemicals already in use and new chemicals being introduced. When TSCA was first used, all chemicals already in use were considered safe and allowed to stay without needing further checks. Its main goals are to test and control new chemicals before they are sold, to control chemicals that existed in 1976 and caused harm to health or the environment, such as PCBs, lead, mercury, and radon, and to manage how these chemicals are used and distributed.

Although its name suggests it divides chemicals into toxic and non-toxic groups, TSCA does not do this. Instead, it stops the making or importing of chemicals not listed on the TSCA Inventory or not covered by specific exceptions. Chemicals on the list are called "existing chemicals," and those not on the list are called "new chemicals." TSCA defines a "chemical substance" as any natural or man-made material with a specific chemical identity, including mixtures formed by chemical reactions or found in nature. However, it excludes chemicals already controlled by other federal laws from this definition.

Usually, companies must notify the EPA before making or importing new chemicals for sale. Exceptions include foods, medicines, cosmetics, and other products regulated by other laws, such as the Federal Food, Drug, and Cosmetic Act, the Federal Insecticide, Fungicide, and Rodenticide Act, and the Nuclear Regulatory Commission. The EPA reviews these notifications and may control the chemical if it finds it poses harm to health or the environment, such as limiting its use or banning it. In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was passed, marking the first major update to TSCA in many years.

Overview

The Toxic Substances Control Act (TSCA) of 1976 required the Environmental Protection Agency (EPA) to protect people and the environment from dangerous chemical risks. This law controls how chemicals are made, used, sold, and disposed of. It does not handle pollution, which is managed by other laws like the Clean Air Act, Clean Water Act, and Resource Conservation and Recovery Act. Instead, like FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act), TSCA focuses on regulating products sold for commercial use. The law gave the EPA power to collect information about chemicals, require testing by manufacturers and importers, and create a list of existing chemicals. It also required companies to report new chemicals to the EPA and allowed the EPA to control chemical production and use. For example, in 2019, the EPA banned the use of methylene chloride in consumer paint and coating removal products.

Chemicals regulated by TSCA are divided into two groups: existing and new. This distinction matters because the law treats these groups differently. Existing chemicals are those already listed on the TSCA Inventory under TSCA section 8(b). New chemicals are defined as any substance not on this list. The list includes all chemicals made or imported into the United States before December 1979, covering 99% of the EPA’s responsibilities under the law, including about 8,800 chemicals produced or imported in amounts over 10,000 pounds.

The TSCA is part of U.S. law found in Title 15 of the United States Code, Chapter 53, and is managed by the EPA.

• Title I of the TSCA, called "Control of Toxic Substances," is the original part of the 1976 law. It sets rules for regulating polychlorinated biphenyl (PCB) products and bans certain uses of elemental mercury.
• Title II, "Asbestos Hazard Emergency Response," allows the EPA to set standards for removing asbestos in schools and requires asbestos workers to be trained and certified. This part was added in 1986 and updated in 1990.
• Title III, "Indoor Radon Abatement," requires the EPA to publish information about radon health risks and study radon levels in schools and federal buildings. This was added in 1988.
• Title IV, "Lead Exposure Reduction," requires the EPA to identify sources of lead contamination, limit lead in products like paint and toys, and support state programs to monitor and reduce lead exposure. This part was added in 1992.

U.S. rules based on the TSCA are found in 40 CFR Part 195 for radon and in 40 CFR Parts 700 through 766 for other matters.

Under 15 USC 2605(e), the TSCA specifically controls PCBs. Subsection (2)(A) states that after January 1, 1978, no one may make, use, or distribute PCBs except in fully enclosed systems. It also allows the EPA to manage how PCBs are disposed of.

Using the TSCA and other laws, the EPA has set limits for PCBs in the environment. It has worked with companies like General Electric and others to clean up areas polluted with PCBs, such as the upper Hudson River.

History

The Toxic Substances Control Act (TSCA) was passed by Congress and signed into law by President Gerald Ford on October 11, 1976, after many years of discussion between the government and chemical companies. A bill was first proposed in Congress in 1971, but it faced opposition from both industry groups and environmental organizations, causing a five-year delay in passing the law. TSCA gave the Environmental Protection Agency (EPA) the power to regulate both new and existing chemicals. The law was created because Congress was worried about the dangers chemicals could cause to people’s health and the environment. TSCA controls how chemicals are made, used, sold, and disposed of, including substances like PCBs, asbestos, radon, and lead-based paint.

In 1971, the Council on Environmental Quality (CEQ) advised the federal government to regulate harmful chemicals in the United States. The CEQ said that current laws were not strong enough to protect people and the environment. For example, existing rules only acted after harm had already happened and did not stop future damage. In 1975, John R. Quarles Jr., the EPA Deputy Administrator, told Congress that while some laws could control certain chemicals like pesticides, most rules only worked after chemicals were already in use. To better manage chemicals, the CEQ suggested the government create a stronger chemical policy. This included requiring companies to inform officials about new chemicals or large amounts of old chemicals, testing chemicals and sharing data with officials, and making information about chemical dangers public.

Congress agreed with the CEQ that more authority was needed to study chemicals and their effects. Between 1972 and 1973, lawmakers proposed several bills in the House and Senate. They also noticed that cancer rates were rising and believed this was linked to the increase of industrial chemicals in consumer products and the environment. These concerns led Congress to act quickly to pass new laws.

Congress based its approach to chemical regulation on three main ideas. First, it was important to understand chemical dangers early and take steps to prevent harm. Second, chemical risks should be addressed in a complete and coordinated way, not in separate pieces. Third, the government needed to collect as much information as possible about chemical toxicity and risks.

Although many people supported the law, it faced delays because of disagreements about how much testing should be done before chemicals were used. However, events like the Kepone disaster in Virginia, pollution of the Hudson River by PCBs, the threat of ozone layer damage from CFCs, and contamination of food by PBBs in Michigan showed the dangers of weak chemical rules. These events helped push the law to pass in 1976.

TSCA was designed to give the EPA more power to study chemicals and their effects on health and the environment. The law covers a wide range of chemicals, including any organic or inorganic substance, combinations of substances from chemical reactions or nature, and elements or radicals. These chemicals are found in products like toys, cleaning supplies, furniture, electronics, building materials, and car interiors. The law aims to manage the production, processing, sale, use, and disposal of these substances. Before the Frank R. Lautenberg Chemical Safety for the 21st Century Act was passed, TSCA required the EPA to use the least disruptive methods to reduce chemical risks while considering the benefits of chemical products.

There have been challenges in using TSCA. First, Professor David Markell from Florida State University said that TSCA and older rules focus on problems after they happen, not before chemicals are used, and they often ignore how to control pollution in communities.

Second, it is hard to implement TSCA because there are many chemicals in the U.S. market, and testing all of them is expensive. In 1976, 62,000 chemicals were already in use, and TSCA allowed these to stay on the market without being tested first. Since then, the number of chemicals on the TSCA list has grown to about 84,000. The EPA has only tested around 200 of these chemicals, and manufacturers have provided little data on the health or environmental effects of 22,000 chemicals introduced since 1976.

Third, even though TSCA allows the EPA to require testing of existing chemicals, it is difficult to get the needed information from companies. Testing by the EPA itself is also very costly.

The EPA can require companies to test chemicals if they are produced in large amounts or if the EPA believes the chemical might harm health or the environment. Companies must share information about the chemical’s identity, uses, how much is made, byproducts, health and environmental effects, how many people are exposed, and how chemicals are disposed of.

To get more information about chemical risks, the EPA often asks companies to test their products. This can happen through agreements between the EPA and companies or through voluntary programs like the HPV Challenge Program. The EPA also created the Sustainable Futures Initiative, which encourages companies to voluntarily test products that might harm health or the environment. Through this program, the EPA hopes to help companies identify and reduce risks.

Regulation of existing chemicals

Currently, chemicals available on the market are listed in the TSCA Inventory. Although the law is meant to protect people from harmful or possibly cancer-causing substances, about 62,000 chemicals were never tested by the EPA because they were "grandfathered in" and not considered a risk by law. These chemicals were allowed to stay on the list of "existing" chemicals without being tested. For existing chemicals, companies must provide information about risks, manufacturing, health effects, and studies related to health and safety, including "substantial risks," to the EPA. If a chemical is subject to a Significant New Use Rule (SNUR), a company must submit a Significant New Use Notice (SNUN) and get approval from the EPA before using the chemical in new ways.

Under Section 4, the EPA has the power to require testing of existing chemicals. However, the EPA must make several formal decisions, the first of which is reviewed by courts to ensure there is strong evidence. Specifically, the requirement that the EPA determine if a chemical "may present an unreasonable risk" creates a challenge because the decision depends on data the EPA cannot access or collect without first making the decision. This difficulty was one reason for changes to Section 4 during TSCA reforms.

In 1989, the EPA used Section 6 to ban the making, importing, and processing of nearly all products containing asbestos in the United States. However, the EPA had limited success using Section 6 to control chemicals that were tested and found harmful. The EPA’s inability to regulate these chemicals led to debates about the legal challenges the EPA faces in banning dangerous substances. Over 38 years, the EPA successfully restricted five chemicals (PCBs, chlorofluorocarbons, dioxin, asbestos, and hexavalent chromium) using Section 6 authority. The asbestos ban was partially overturned in 1991. The EPA has also limited the use of some existing chemicals through Section 5 SNURs.

As of 2015, 250 of the more than 60,000 existing chemicals were directly tested by the EPA. Of these, 140 were tested because the EPA ordered it, and 60 were tested after companies agreed voluntarily. Additionally, there are 3,000 high production volume (HPV) chemicals, which are made or imported in amounts exceeding one million pounds per year. These HPV chemicals make up about one-third of existing chemicals, but their large quantities raise concerns about the lack of basic information about their dangers. Many environmental groups, such as the Natural Resources Defense Council, express concerns that the EPA has limited ability to act against dangerous chemicals, even those known to cause cancer or serious health effects. The HPV program led to the creation or release of data on over 2,200 chemicals.

Regulation of new chemicals

Companies must inform the Environmental Protection Agency (EPA) if they plan to make or bring into the United States a new chemical that is not already on the Toxic Substances Control Act (TSCA) Inventory. This notice, called a Premanufacture Notice (PMN), must be submitted at least 90 days before the first production or import for a non-exempt purpose. Section 5 of TSCA does not require companies to perform any toxicity tests before submitting a PMN. No safety information is needed in the PMN, so the EPA must use computer models to decide if the new chemical might cause harm to health or the environment.

To regulate a new chemical, the EPA must determine if it could cause unreasonable harm to health or the environment or if it will be made in large amounts and may enter the environment or be exposed to people. If the EPA cannot meet these conditions, it cannot stop the chemical from being made. The EPA has only 90 days from receiving a PMN to act. If it does not act within this time, the chemical may legally be used in products.

Because of this time limit, only 40% of tests for acute toxicity and mutagenicity (ability to cause genetic changes) are completed. Even less data is collected about long-term effects, such as subchronic, neurotoxicological, developmental, reproductive, and chronic effects. Less than 5% of data about harm to aquatic organisms is included in PMNs. Between 1979 and 1994, the EPA received over 24,000 PMNs and requested delays or more data for only 5,000 of them. Half of these chemicals were still on the market.

EPA evaluations found that 85% of health effect data in PMNs is incomplete, and 67% of PMNs have missing information about health or environmental risks. To address this, Section 5 of TSCA created the Structure Activity Team (SAT) and structural-activity relations (SARs) to review PMN chemicals. SAT is a group of scientists who assess how new chemicals might behave in the environment and their potential health or environmental risks.

Because PMNs often lack data, hazard assessments rely heavily on computer models, SARs based on similar chemicals, or public databases like Beilstein. However, some argue that SARs and SAT reviews do not fully evaluate risks. For example, there is no required minimum set of data beyond what is already known when a PMN is filed. The EPA can only regulate chemicals already on the market under TSCA standards and must prove the safety of existing chemicals.

Chemical Substance Inventory (TSCA Inventory)

The TSCA Chemical Substance Inventory (TSCA Inventory) is the Environmental Protection Agency's (EPA) complete list of secret and non-secret chemical substances. The non-secret part of the inventory is available in Microsoft Access and CSV formats inside ZIP files. Companies report inventory information using a new online system called the Central Data Exchange (CDX) Chemical Safety and Pesticide Programs (CSPP) web application. Only company officials and their team members can use this system; the public cannot access it. The Toxics Release Inventory (TRI) is a separate list used for Superfund reporting.

Criticism

The Toxic Substances Control Act (TSCA) has faced criticism from groups outside the government, scientists, academics, and even some government agencies. These groups say TSCA has not been updated enough to properly protect human health and the environment from harmful chemicals. Before changes to TSCA in 2016, the law had not been significantly improved. Organizations that care about product safety, including the chemical industry, environmental and public health groups, and the Environmental Protection Agency (EPA), have tried to fix problems caused by weak rules. They say the law does not work well because of legal, organizational, and political issues. According to Wilson and Schwarzman, there are three main problems with U.S. chemical policies:

• Data gap: Companies are not required to study or share enough information about the dangers of chemicals with the government, the public, or businesses that use them.
• Safety gap: The government does not have enough legal tools to find, prioritize, and take action against harmful chemicals that could hurt health or the environment.
• Technology gap: Both industry and the government have invested very little in research, development, and education about safer chemical practices.

In 2010, the EPA Office of the Inspector General said TSCA implementation has been "inconsistent and weak." The report criticized the EPA for handling new TSCA cases in a way that favors protecting company information over sharing health and safety studies with the public. The Government Accountability Office (GAO) says that rules protecting trade secrets are stopping effective testing. In some cases, studies about chemical toxicity do not include the identity of the chemical being tested, so they cannot report problems because "health and safety data are not useful if the chemical they relate to is unknown."

Some state governments have created "comprehensive regulatory programs" to control toxic chemicals more strictly because Congress has not updated TSCA. Critics say TSCA is not strong enough to stop states from passing their own laws. Since 2003, lawmakers in 18 states have passed 71 chemical laws. In states like California, Connecticut, and Michigan, laws have been introduced to regulate chemicals more strictly to protect people and the environment from dangerous exposures.

People who want federal changes to TSCA say state laws create conflicts between federal and state powers. State laws that target chemicals have strong public support. These laws have successfully added more rules about chemicals like BPA in plastic products and food containers or flame retardants in furniture. Campaigns that teach people about chemicals in products have helped them understand the risks of exposure to harmful substances. A poll by the Mellman Group found that 78% of Americans are seriously worried about toxic chemicals harming children, and 33% say everyday exposure to toxic chemicals is a major problem.

In 2009, chemical manufacturers said TSCA needs "modernizing" to better regulate current and future chemicals. They are frustrated with state laws because they create "market problems and unnecessary rules" without improving public health. They reluctantly support TSCA reforms to avoid confusion. They want federal rules that would replace state laws, so they can follow one standard for selling products nationally or internationally without dealing with many different state rules. However, environmental groups and state agencies say TSCA rules protect "confidential business information" (CBI), which stops them from getting information needed for their work. Chemical companies and their groups want a weaker version of TSCA that replaces state laws because there are more than 40 different state rules about toxic chemicals. They also want one standard for all states instead of many different rules. Chemical companies have also used quality management systems to improve safety in their industry.

Public concern about dangerous chemicals in daily life has led state and local agencies to act. New policies are needed to address consumer demand: "rules about chemicals need to change based on new science about their health and environmental effects." Better management of chemicals can be achieved through "campaigns that teach people about chemicals in products," which have made people aware of "chemical exposure in everyday life" by sharing information about chemical dangers. Labeling is another solution that lets consumers choose products based on safety standards that ensure "no harm." The private sector has responded by using "screening systems" to stop selling products with chemicals that could harm health or the environment. Demand for sustainable products can push the market to use more green chemistry.

Opponents of TSCA reforms say strict laws could hurt jobs. However, demand for sustainable products can encourage innovation and investment in new products that replace toxic chemicals. Green chemistry is a way to design chemicals that are less harmful, with the goal of making chemicals and products "safe by design." A group called the Safer Chemicals, Healthy Families Coalition says "18 states have passed 71 chemical laws since 2003." California started the California Green Chemistry Initiative (CGCI) to increase innovation and reduce harmful chemicals in products. The CGCI responds to consumer and environmental group demands for greener products.

Other groups that care about TSCA's weaknesses include 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, which together represent more than 11 million people. These groups, part of the Natural Resources Defense Council, were unhappy with a new TSCA draft bill written by Senator Lautenberg in 2013. They wanted more oversight and reporting about chemical dangers in everyday products.

New technologies, like nanotechnology, have introduced products with ultra-fine nanoparticles that can enter the body through the skin, lungs, or intestines.

TSCA and environmental justice

The Toxic Substances Control Act (TSCA) can help protect communities where people from minority groups and those with low incomes are more likely to be exposed to harmful chemicals. This exposure increases their risk of developing long-term health problems, such as prostate cancer, learning disabilities, asthma, infertility, and obesity. Public policies can help communities fight against unfair treatment related to harmful industrial activities that are often located near low-income neighborhoods. These communities face greater risks from pollution, unsafe housing, and harmful resource extraction, and they cannot wait for long processes to confirm their health has been harmed.

Studies show that people with lower incomes are more likely to live near industrial facilities that pollute. Companies often choose to build these facilities in areas where land is cheaper and where workers and materials are available. Over time, these facilities can lower the value of nearby homes because of noise, pollution, and health concerns. Wealthier communities usually try to stop such facilities from being built near them, but low-income neighborhoods and communities of color are often targeted because they are not well organized or represented. This leads to unfair environmental conditions that affect low-income people, who may be unable to move to safer areas due to discrimination in housing.

Environmental justice groups can work with communities to influence local, state, and federal policies. TSCA can help protect public health by limiting the use of dangerous chemicals and encouraging safer production methods. People who are more vulnerable, such as children, pregnant women, the elderly, and workers, face higher risks from chemical exposure. The elderly are at risk because their immune systems are weaker, and chemicals may worsen health conditions or interact with medications. Children are more vulnerable because their immune systems are not fully developed, and their small bodies cannot handle large amounts of chemicals. To protect these groups, governments at all levels should create better policies to reduce chemical exposure. The Frank R. Lautenberg Chemical Safety for the 21st Century Act includes a rule that requires the Environmental Protection Agency (EPA) to evaluate risks to groups that may be more likely to be harmed by chemicals.

Children are more likely to develop long-term health issues from chemical exposure, which can lead to illnesses such as asthma, lead poisoning, and obesity. It is estimated that lead poisoning in children costs about $43.4 billion each year in the United States. Toxic chemicals can harm the health of unborn babies, infants, children, and teenagers. It is important to protect children because they are less able than adults to process and remove harmful chemicals from their bodies.

Children are exposed to new chemicals used in products, which can be found in air, food, water, homes, schools, and communities. People living near areas with high pollution face health problems linked to both environmental and social stressors, which can place a greater burden on families. Information about the safety of chemicals can help parents make better choices about the products they buy for their children. However, only about two-thirds of the 3,000 most commonly produced chemicals have known safety information. Policies that protect vulnerable groups can reduce children's exposure to harmful substances. For example, in 2008, the state of Maine passed the Kid-Safe Act to reduce children's exposure to lead in toys and a chemical called bisphenol A (BPA) in baby bottles.

In January 2016, the Center for Science in the Public Interest released a report called Seeing Red – Time for Action on Food Dyes, which criticized the continued use of artificial food coloring in the United States. The report said that more than half a million children in the U.S. experience negative behavior changes after eating food dyes, costing about $5 billion each year. The report asked the Food and Drug Administration to stop or limit the use of these dyes. It is important to note that baby bottles and artificial food dyes are not regulated by TSCA, but instead by the Federal Food, Drug, and Cosmetic Act. However, other harmful chemicals found in baby food, such as bisphenol A, are regulated by TSCA.

Exposure to toxic chemicals during pregnancy can harm the health of the mother and the developing baby. This can increase the risk of birth defects, childhood illnesses, and disabilities later in life. Health professionals can help women who are pregnant or planning to become pregnant avoid harmful chemicals. Eating healthy food, such as organic food, can reduce the effects of toxic chemicals. Breastfeeding mothers can pass harmful chemicals to their babies through breast milk. When children switch from regular food to organic food, the amount of pesticides in their bodies decreases. However, low-income families may not be able to afford organic food. Pesticides are not regulated by TSCA but by the Federal Insecticide, Fungicide, and Rodenticide Act. Other harmful chemicals that can be passed through breast milk, such as per- and polyfluoroalkyl substances (PFAS), are regulated by TSCA.

According to the Occupational Safety & Health Administration (OSHA), workers have the right to a safe workplace that does not cause serious harm. Workers can be exposed to harmful chemicals through skin contact, breathing, eating, or eye contact. Some jobs involve more exposure to dangerous chemicals, which can cause long-term health problems. If the body cannot remove these chemicals quickly enough, they can build up and harm the body. Exposure to chemicals can also affect the ability of men and women to have children. The Frank R. Lautenberg Chemical Safety for the 21st Century Act includes a rule that protects workers as part of the definition of groups that may be more likely to be harmed by chemicals.

Companies can show responsibility by removing harmful products from the market and offering safer alternatives. For example, Kaiser Permanente, a major medical supply company, avoids using chemicals linked to cancer, reproductive issues, and genetic changes. Corporate social responsibility means that companies should act in ways that respect communities and follow ethical values while working to improve society.

Reform bills

On May 23, 2013, Senators David Vitter (R-LA) and Frank Lautenberg (D-NJ) introduced a TSCA reform bill. The bill was supported by many other senators at the United States House Energy Subcommittee on Environment and Economy. The main goal of this effort was to change TSCA's subsection S.1009, known as the Chemical Safety Improvement Act (CSIA). The Environmental Defense Fund believed this change would give the EPA important tools to improve public health protections and strengthen TSCA.

The bill’s key changes included requiring safety evaluations for all chemicals currently in use, ensuring new chemicals are proven safe before entering the market, fixing flaws in TSCA’s safety standards that prevented the EPA from banning asbestos, allowing the EPA to order chemical testing without first proving a risk, and making more chemical information available to states, health professionals, and the public by limiting rules that keep chemical data private.

The 2014 West Virginia Chemical Spill caused problems for the CSIA. No data about the spilled chemical were available, including information about its effects on health, such as repeated dose toxicity, cancer risk, reproductive harm, and effects from long-term exposure. On February 4, 2014, the Senate Committee on Environment and Public Works held hearings on the CSIA after the spill. Following the incident, the House passed a bill 95-0 that added protections for chemical storage tanks and public water supplies. This bill required new rules for early detection technology and plans to prevent drinking water contamination.

The CSIA was supported by several groups, including 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.

In March 2015, Senator Tom Udall (D, NM) introduced Senate bill 697, which aimed to update and renew TSCA. The bill was called the "Frank R. Lautenberg Chemical Safety for the 21st Century Act." Environmental, health, and labor groups, along with several states, criticized it because they believed it would weaken state rules on chemicals. However, EPA officials, including Administrator Gina McCarthy, stated the bill met the Obama Administration’s goals for TSCA reform and supported the bipartisan progress. Another bill, Senate bill 725, introduced by Senator Barbara Boxer (D-CA) and Senator Edward Markey (D-MA), called the "Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act," would allow the EPA to quickly assess chemical safety and support new state policies.

In June 2015, the House passed H.R. 2576, the TSCA Modernization Act of 2015, and sent it to the Senate.

On January 20, 2016, Gina McCarthy, the EPA Administrator, wrote a letter to Congress explaining the EPA’s views on S. 697 and H.R. 2576. The letter discussed support and concerns about TSCA reform, including deadlines for action, removing the "least burdensome" rule for Section 6 regulations, securing funding, reviewing existing chemicals, applying new safety standards to all chemicals, transparency, confidential business information, chemicals in products, and state rules.

In early June 2016, Congress passed a final version of the reform bill, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, with support from both parties. On June 22, 2016, President Barack Obama signed the bill into law, saying that "even in a divided political environment, progress can happen." Lawmakers and industry groups generally supported the new law, while environmental groups had mixed reactions.

Comparison with EU chemical regulation

The European Union (EU) passed laws called Registration, Evaluation and Authorization of Chemicals (REACH) on June 1, 2007, to improve how chemicals are managed.

There are three main points to compare REACH and TSCA.

Having enough information helps manage risks and prevent harm from dangerous chemicals. Useful information includes scientific details about a chemical’s composition, technological methods to monitor or control risks, and legal rules about the rights and responsibilities of producers, consumers, and the public. Under TSCA, chemical companies must share data about the health and environmental effects of existing chemicals with the EPA. However, TSCA does not require companies to test new chemicals for health or environmental effects, though they can choose to do so voluntarily. Section 5 of TSCA requires companies to submit data if they already know about potential risks when they submit a premanufacture notice (PMN) to the EPA. To address gaps in data, the EPA uses a method called structure-activity relationship (SAR) to estimate risks. By the 1980s, less than half of new chemicals evaluated by the EPA had toxicity data, which mostly included tests for skin or eye irritation or effects on laboratory animals. TSCA also requires companies to provide information about a chemical’s physical and chemical properties, how it behaves in the environment, and its health and environmental effects when they submit a manufacturing notice. The EPA compares new and existing chemicals by their molecular structures to identify risks. Under TSCA Section 8(d), the EPA can ask companies to share unpublished health and safety studies for chemicals made in the 10 years before a rule is created. In 2021, the EPA used a data call-in rule under Section 8(d) to gather information about many chemicals being evaluated or considered for priority.

Under REACH and the European Chemicals Agency (ECHA), chemical companies must report the amounts of chemicals they produce. Depending on the quantity, companies must provide more information about health and environmental risks for both existing and new chemicals. For example, at one or more tonnage, companies must submit details like chemical identity, production methods, usage instructions, safety guidance, and summaries of physical and chemical properties. At 10 or more tonnage, companies must also provide chemical safety assessments, hazard information, and data about persistence, bioaccumulation, and toxicity. At 100 or more tonnage annually, additional data is required, such as bioaccumulation tests, simulations of chemical breakdown, long-term effects on aquatic life, short-term effects on plants and soil, two-generation toxicity studies, and subchronic toxicity data for mammals.

Under TSCA, the EPA uses models or data from similar chemicals to fill gaps in information about a chemical’s properties, toxicity, or environmental behavior. Under REACH, ECHA requires companies to fill data gaps using their own data, data from similar chemicals, models, or waivers if justified.

TSCA requires the EPA to collect data to assess chemical risks and gather strong evidence to support decisions and legal actions. Section 6(a) of TSCA makes it difficult for the EPA to prove that some chemicals are dangerous because it requires showing the chemical’s effects on health and the environment, the level of exposure, the chemical’s benefits, and the economic impact of regulations. Section 6 also limits the production of certain chemicals like PCBs, dioxin, asbestos, and hexavalent chromium. Section 5a2 of TSCA requires companies to notify the EPA before manufacturing, importing, or processing 160 existing chemicals for new uses. TSCA uses models like ecological risk assessment, exposure assessment, and dose-response analysis to evaluate risks.

REACH requires chemical manufacturers, importers, and users to ensure chemicals do not harm health or the environment. Companies must seek authorization to produce or import hazardous chemicals and find safer alternatives. The authorization process involves ECHA publishing a list of chemicals, the European Commission deciding whether to authorize or exempt chemicals, and companies applying for authorization if they can show benefits outweigh risks. Like TSCA, REACH restricts chemicals that pose unacceptable risks by proving their harm to health or the environment and identifying safer substitutes.

Sharing information helps the public avoid chemical risks by changing consumer habits or pressuring companies. TSCA allows companies to keep some information confidential, such as chemical volumes or uses, unless health or safety studies are needed. The EPA can only share confidential data if it is necessary to protect health or the environment. Local and state agencies need chemical information to prepare for emergencies involving toxic substances. REACH requires companies to share basic health and safety information with the public, including chemical profiles, authorized uses, and risk management steps. A key strength of REACH is its requirement for companies to disclose detailed information about chemicals to the public.

Example of chemical inventories in various countries and regions

• REACH – European Union Regulation number 1907/2006
• AICS – Australian Inventory of Chemical Substances
• DSL – Canadian List of Chemicals Found in Canada
• NDSL – Canadian List of Chemicals Not Found in Canada
• KECL (Korean ECL) – Korean List of Existing Chemicals
• ENCS (MITI) – Japanese List of Existing and New Chemicals
• PICCS – Philippine Inventory of Chemicals and Chemical Substances
• TSCA Inventory – Toxic Substances Control Act in the United States
• SWISS – Giftliste 1
• SWISS – List of Newly Notified Chemicals in Switzerland