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	15 U.S.C. ch. 53, subch. I §§ 2601–2629
Legislative history
Introduced in the Senate as S. 3149 by Sen. John V. Tunney (D–CA) on March 16, 1976 Committee consideration by Senate Commerce, House Commerce Passed the Senate on March 26, 1976 (60-13) Passed the House of Representatives on August 23, 1976 (319-45, in lieu of H.R. 14032) 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 and 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. Its 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.^[1] 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).^[2] Chemicals that are listed on the TSCA Inventory are referred to as "existing chemicals", while chemicals not listed are referred to as new chemicals.^[2] 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".^[2] 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),^[3][4] 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. The Chemical Safety Improvement Act was proposed in 2013 as the first major overhaul in many years.^[5]

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.

Sections

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.

History

The TSCA was passed by the United States Congress and signed into law by President Gerald Ford on October 11, 1976, after many years of negotiation between different factions of the government and chemical producers.^[6] As one of the most important pieces of legislation ever passed in the United States, TSCA authorized the Environmental Protection Agency (EPA) to regulate new and existing chemicals.^[6] TSCA was response to Congress’ growing concerns about the unreasonable risks that chemicals pose to human health and the environment.^[6] TSCA limits the manufacture, processing, commercial distribution, use, and disposal of chemical substances including polychlorinated biphenyls (PCBs), asbestos, radon and lead-based paint.^[6]

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.^[7] CEQ explained that existing regulation was not sufficient enough 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.^[8] As Johan Quarles, the EPA Deputy Administrator, later explained during a 1975 Congressional Testimony, "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.”^[9] In Order to adequately regulate what chemical should enter the environment, CEQ recommended that the government create a more comprehensive chemical policy to identify and control the chemical that are manufactured, produced, and used in the U.S economy.^[7] 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.^[8] 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.^[8] Lastly, with this information, the government should disclose any information about the health effects caused by dangerous chemicals to the public.^[8]

Congress’ response to CEQ and the drafting of TSCA

The U.S. Congress agreed with CEQ that additional authority is required to test chemicals in order to determine their effect, and responded to the CEQ’s recommendation by proposing many House and Senate bills between 1972 and 1973.^[7] 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.^[8] As a result of these concerns, Congress concluded the risk of chemical exposure to the public were serious enough to warrant swift legislative action.^[8]

Three key assumption informed Congress approach to drafting a chemicals control policy.^[8] 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.^[8] Second, toxic risk should be approached in “holistic rather than fragmented” manner.^[8] Third, it is important to collect as much information as possible about the toxicity of chemical and the risk associated with them.^[8]

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 of chemicals prior to commercial production.^[7] However, a series of environmental disasters such as contamination of “Hudson River and other water ways by polychlorinated biphenyl (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.^[7] Congress designed TSCA to empower the EPA to collect more information on chemicals and their potential dangerous effect on human health and the environment.^[10] As a result, TSCA's Jurisdictional Scope is extremely broad.^[8] Congress’s definition of chemicals 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.".^[11] These chemicals are found in children’s products (e.g., toys) cleaning products, personal care products, furniture, electronics, food and beverage containers, building materials, and car interiors. The law attempts to oversee the manufacturing, processing, disturbing, using and or disposing of such chemical substances.^[8] TSCA directs 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.^[7] Specifically, TSCA directed the EPA as follows:

• "Title I of the original statute establishes the core program, directs EPA to control risks from polychlorinated biphenyls (PCBs), and bans certain activities with respect to elemental mercury.
• Title II directs EPA to set standards for asbestos mitigation in schools and requires asbestos contractors to be trained and certified.
• Title III directs EPA to provide technical assistance to states that choose to support radon monitoring and control.
• Title IV provides similar assistance with respect to abatement of lead-based paint hazards."^[7]

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.^[8]

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.^[8] According to Pure Water Alternatives, in 1977, the American Chemistry Council listed over 4 million toxic substances in production in the U.S.^[12] In the 1970s there were close to 62,000 chemicals on the market that were covered by TSCA^[13] TSCA “grandfathered” these 62,000 chemicals, allowing these substances to remain on the market without assessing toxic impacts. New chemicals, however, would be subject to review for health and environmental risks. Since then, it is estimated that new chemicals have been introduced at a rate of 6,000 per-week^[12] but the list of chemicals registered under TSCA has only grown to roughly 84,000.^[14] Furthermore, TSCA only covers certain chemical substances so not all potentially hazardous chemicals are regulated. 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.^[15]

Third, even though TSCA gives permission to the EPA to test the existing chemicals through the EPA’s own rule making process, the EPA has difficulty obtaining the data needed to determine their risks. It is difficult to collect information from industries about the risks of chemicals and the EPA has concluded that conducting its own testing is too costly.^[8]

The EPA is supposed to require testing of chemicals being produced in substantial quantities.^[16] EPA relies on industry to test chemicals only if the industry suspects that the manufacturing, production or use of a chemical can pose a serious danger to public health.^[16]

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.^[7] In order to obtain more information related to chemical risks, the EPA must ask chemical companies to do testing. This occurs either by (1) mutual agreement, or (2) voluntary industry efforts under the HPV Challenge Program.^[8] EPA has also created the Sustainable Futures (SF) Initiative model, which allows companies to voluntarily test their products that might pose risks to human health or the environment.^[17] Through this initiative, EPA hopes to reduce risk, produce safer chemicals in a shorter amount of time, and to save money.^[17] It intends to yield better results in bringing safer chemicals into the market.^[17]

Regulation of existing chemicals

Currently existing chemicals on the market are listed in the TSCA Inventory.^[18] 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 "grandfathered in and statutorily not considered an "unreasonable risk."^[19] Without testing, TSCA grandfathered the use of these chemicals into TSCA's list of "existing" (as opposed to "new") chemicals. For existing chemicals, manufacturers need to generate and report to EPA data on risk, manufacturing and processing, adverse health effects, published and unpublished health and safety studies, and “substantial risks.”^[20] Also, manufacturers need to report their chemicals’ significant new use rules (SNURs), but this triggers a further PMN process of existing chemicals. The weak PMN screening system gives the EPA little support for gathering information about existing chemicals, which constitute the vast amount of chemicals in commerce^[20] Yet, under section 4, EPA has the authority to require manufacturers to test existing chemicals, but in each case EPA must make several formal findings, the first of which is subject to judicial review under the “substantial evidence” standard.^[20] In particular, the requirement that EPA determine that the chemical “may present an unreasonable risk” creates a regulatory Catch-22 as such a determination requires much of the very data that the EPA cannot access or cause to be generated without first making the determination.^[20]

EPA issued a final rule under section 6 in 1989 to ban the manufacturing, importing, and processing of nearly all asbestos-containing products in the USA.^[21] 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.^[21] EPA’s failure to adequately regulate these chemicals caused strong debates over the legal burden EPA bears in banning chemicals.^[21] In fact, the agency has been successful in restricting only five chemicals (PCBs, chlorofluorocarbons, dioxin, asbestos, and hexavalent chromium) in its 38-year history,^[22] and the ban on asbestos was overturned in 1991.^[23]

As of 2015 only 250 of the more than 60,000 existing chemicals have been directly tested by the EPA.^[24] 140 of those were tested by regulatory order and 60 were tested only after voluntary consent by the manufacturer.^[25] Additionally, there are 3000 high production volume chemicals (HPV), produced or imported in quantities exceeding one million pounds per year^[25] These HPV chemicals only constitute one third of existing chemicals, but their high volumes raise concern about the lack of basic hazard information.^[25] 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.^[19]

Regulation of new chemicals

Companies must notify EPA of their intention to manufacture a new chemical not listed in the 1976 act by using a Pre-Manufacturing Notice (PMN). Section 5 of the Toxic Substances Control Act (TSCA) does not require any toxicity testing before submitting a PMN^[26] 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 present an unreasonable risk."^[27] In order to regulate new chemicals, EPA must determine that the chemical “...may present an unreasonable risk to human 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....”^[26] If EPA does not satisfy these requirements, it cannot act to block the manufacture of the new chemical. EPA has only 90 days from receipt of a PMN to act before the new chemical may be legally marketed and included in products. In consequence, only 40 percent of acute toxicity and mutagenicity testing is ever completed, even less data on long-term effects or specific endpoints (including subchronic, neurotoxicological, developmental, reproductive, and chronic) is ever generated. Additionally, less than 5 percent of data on toxicity to aquatic organisms is submitted with a PMN. ”^[26] From 1979 to 1994 EPA OPPT’s new chemical program received over 24000 PMNs and sought to delay manufacture and require additional data for only 5000 of those submissions. Half of these nonetheless ultimately entered and are still on the market.^[21]

Moreover, EPA evaluation found that 85 percent of PMN data on health effects is deficient, and 67 percent of PMNs contain deficiencies on health or environmental effects of any kind.^[25] In order to compensate for this deficiency of data, Section 5 of TSCA created The Structure Activity Team (SAT) along with structural-activity relations (SARs) to review PMN chemicals. SAT consists of a team of expert scientists and specialists who evaluate the potential environmental fate, and health and environmental hazards of new chemicals^[26]

Since there is little to no data received with the PMNs, hazard assessments for chemicals depend heavily on models, SARs based on analogous chemicals, or, in some cases, data on the subject chemical retrieved from public databases or reference material such as Beilstein.^[26] However, it has been argued that SARs and SAT’s review process do not adequately insure against the potential risks associated with the new chemicals.^[21] For instance, there is no minimum data set beyond information already in possession at the time they file the PMN. The EPA may regulate chemicals that enter the market only under the standards of TSCA and also carries the burden of proving the safety of existing chemicals^[25]

Criticism

TSCA has been severely criticized by non-governmental organizations, academics, scientists, and even government agencies for failing to effectively regulate the safe use of chemicals affecting human health and environmental welfare.^[25][28] Since the creation of TSCA in 1976, “the act has not been substantially updated.”^[29] Organizations concerned about product safety, “including the chemical industry, environmental and public health advocates, and the EPA”^[29] have attempted to mitigate the effects of weak regulation. They argue that “the inability to function as intended results from a series of legal, organizational, and political challenges."^[29] According to Michael P. Wilson and Megan R. Schwarzman, researchers at the Center for Occupational and Environmental Health, School of Public Health, University of California at Berkeley, there are three gaps in U.S. chemicals policy:

• "Data gap: Producers are not required to investigate and disclose sufficient information on the hazard traits of chemicals to government, the public, or businesses that use chemicals.
• "Safety gap: Government lacks the legal tools it needs to efficiently identify, prioritize, and take action to mitigate the potential health and environmental effects of hazardous chemicals.
• "Technology gap: Industry and government have invested only marginally in green chemistry research, development, and education."^[25]

The EPA's use of TSCA to regulate dangerous chemicals is seen as a failure by many, including the Office of the Inspector General, who says the implementation has been "inconsistent and presents a minimal presence" in a report dated February 17, 2010.^[30] The same report also 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."^[30] It suggests that concern for trade secrets is 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."^[30]

State regulation of toxic substances and chemicals

State governments have implemented "comprehensive regulatory programs"^[31] for stricter control on toxic chemicals as a response to the failure of Congress to modernize TSCA.^[32] Some critics of TSCA note its inability to support meaningful action to prevent a patchwork of state polices as state lawmakers in 18 states have collectively passed 71 chemical laws since 2003.^[21][33] 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.^[21] Critics favoring a federal reform of TSCA argue that the patchwork of state chemical management laws create “tensions between federal and state powers.”^[34] Moreover, state law initiatives and rules to target chemicals have significant support from “the public demanding stricter chemical control."^[25] Stringent state laws have successfully implemented more regulation on "BPA in plastic products and food beverage containers or flame retardants in furniture."^[25] Campaigns focusing on increasing consumer awareness of chemicals in products have been able to educate the public about the potential risk of exposure to chemical products that can harm their health and the environment.^[25] According to a poll conducted by the Mellman Group, 78 percent of Americans are seriously concerned about the threat to children’s health from toxic chemicals in day-to-day life. The same poll reported that 33 percent of the respondents answered that everyday exposure to toxic chemicals is a serious issue.^[25]

Chemical industry’s support for TSCA reform

In 2009, chemical manufacturers stated that TSCA needs “modernizing”^[21] to offer better regulation of current and future chemical products available in the market. The chemical industry is frustrated with state-level restrictions because state policies on chemical products create “market disruption and impose unnecessary regulatory burdens, without necessarily improving public health.”^[21] The chemical manufacturers “reluctantly” support a reform of TSCA, agreeing that it is necessary to avoid ambiguities. The chemical producers support implementation of more uniform and consistent regulations at the federal level that pre-empt state law.^[21][35] 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.^[21][35] Yet, environmental groups and state agencies argue that TSCA provisions “protect confidential business information” (CBI) preventing them from accessing information relevant to their task.^[21] 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 and overlapping sets of requirements to the individual states where the companies do business. Chemical manufacturers have also automated quality processes by incorporating a quality management system in efforts to foster a better, safer industry.^[36]

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.^[21] Redefining is needed to respond to the consumer demand: “public policies governing chemical design, production, and use need deep restructuring in light of new science on the health and environmental effects of anthropogenic chemicals”^[37] For better management and control of chemicals “a string of high-profile campaigns focusing on chemicals in consumer products”^[21] has made consumers aware of “chemical exposures to everyday life”^[21] by releasing information on the hazards and outcome of chemical use. Labeling is an alternative solution to give the consumer the freedom to choose what products to buy “as a condition for entering or remaining on the market, using a standard that establishes a reasonable certainty of no harm.”^[35] The private sector responded to the public concern of chemical exposure in everyday life by incorporating “screening mechanism(s) to diminish and/or prevent the marketing of products containing chemical substances that could potentially adversely affect human health and the environment”^[21] The demand for sustainable products can force the market to adopt more green chemistry.^[25]

Technological innovation and TSCA reform

Opponents to TSCA reform proposals argue that stringent legislation can be seen as “job-killing.”^[21] Nevertheless, the demand for sustainable products can increase innovation and investment in new products that can eventually replace toxic chemicals. Green chemistry is an innovative way to deal with chemicals before they become hazards, with the goal of making chemicals and products “benign by design.”see CGCI^[38] According to the Safer Chemicals, Healthy Families Coalition, “18 states have collectively passed 71 chemical laws since 2003.”^[28] Similarly, the state of California implemented the 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.^[39] Regulation of toxic chemicals can bring more innovation.

Green technology innovation introduced new products using nanotechnology available for consumption. The ultra fine nano particles can enter the human body via the skin, lungs or intestinal tract and may induce undesirable genetic changes as a side effect.^[40] 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."^[40] 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.^[41][42][43] 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.^[28] Nevertheless, in Europe new regulation motivated the chemical industry to innovate. For instance, the European parliament implemented a successful comprehensive reform of REACH by applying the “No data, no market” rule to pressure chemical manufacturers to submit safety data for both new and existing chemicals produced in or exported to Europe. This approach motivated the chemical industry in Europe to innovate, invest more in research & development and produce greener products.^[44]

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.^[19] 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.^[19]

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.”^[28] Public policy can transform and empower communities “fighting environmental racism.”^[45] 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.^[46] 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.”^[45] The market dynamics responds to “the industry seeking to build their facilities where land is cheap and where industrial labor pools and sources of materials are nearby.”^[45] Eventually, industrial facilities may contribute to the depreciation of property in the neighboring areas affecting the value of housing because of noise, release of pollutants, and fear of health impact.^[45] Wealthy communities will actively oppose the placing of industrial facilities near them but the low-income neighborhoods “and communities of color become an easier target”^[45] as they are not well represented or well organized to fight against the industry and the government. Environmental disparities is a prevalent issue for low income-people as they become trapped in “housing discrimination”^[45] living in polluted neighborhoods unable to relocate to a nicer area.^[45]

Populations vulnerable to toxic and chemical substances exposure

Environmental justice groups can engage the community to impact local state and federal policy. TSCA regulation can protect public health by “limiting the market for hazardous chemicals and promote safe chemical production.”^[28] Vulnerable population such as infants, pregnant women, the elderly and certain occupational workers bear a higher risk to diseases from exposure to toxic chemicals. The elderly are vulnerable from exposure to chemicals that may impair their weak immune system, and cause heart disease among other health issues from interactions with medication. Children are vulnerable to the health impacts of environmental injustice because their immune system is immature and they cannot handle the amount of chemicals in relation to the size of their body. To protect vulnerable groups the federal, state and local government could implement better policy to protect them from the increasing number of chemical exposure happening in daily basis.^[47][48]

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."^[49] Toxic chemicals "threaten the health of the developing fetus, babies, young children and teens.”^[28] It is important to protect children from chemical exposures as they “are less able than adults to break down and excrete toxic compounds.”^[35] Children are exposed to newly invented chemicals used for consumer products, and is also found in “air, food, water, homes, schools, and communities.”^[50] Communities living near hot spots present health problems “associated with both social and environmental stressors,”^[51] 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.”^[50] Policy and regulation to protect vulnerable groups can reduce the exposure of children to toxic substances. For instance, in 2008, the state of Maine implemented the Kid-Safe Act to protect children from exposure to lead in toys “and bisphenol A (better known as BPA) in baby bottles”^[28][52] 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. ^[53]

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.”^[54] 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^[55][56]

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.^[57][58] For example, farm workers including a large number of seasonal migrant workers are exposed to variety of occupational risks and hazards. Communities near agricultural farms may be at higher risk for exposure to pesticides. Farm workers are exposed to pesticide-related illness from the use of chemicals that can have delayed health effect such as cancer and reproductive dysfunction. Among the chemicals farmers get exposed, Dibromochloropropane (DBCP), a soil fumigant used to control nematodes can lead to “testicular toxicity and human reproductive dysfunction.”^[59] Other health problems from their exposure to chemicals include “acute systemic poisoning, nausea, dermatitis, fatigue and abnormalities in liver and kidney function”, farmers and their family are exposed to toxic chemicals when the farm worker leaves the field and has contact with family members wearing contaminated clothes.^[60]

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.^[61] For instance, “Kaiser Permanente, a major medical supply purchaser, has a policy to avoid chemicals associated with cancer, reproductive problems and genetic mutations.”^[62] 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."^[63] 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.^[64]

Reform bills

2013

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.^[65] The main focus of this effort was to amend TSCA’s subsection S.1009, the Chemical Safety Improvement Act (CSIA). According to the Environmental Defense Fund, if the reformation had been passed, it would have given the Environmental Protection Agency many critical tools to significantly strengthen the provisions on public health protection and improved TSCA.^[28]

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 EPA’s inability to ban asbestos, allowing 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.”^[28]

A number of environmental groups criticized CSIA, such as the Environmental Working Group(EWG), Earthjustice, and the Environmental Defense Fund. Environmental and victim's groups were highly critical of the bill as Section 15 contained broad language preempting all state personal injury or environmental litigation relating to any chemical listed on the registry.^[66][67] This means it would have kept states from enacting their own laws and void any laws already in place, something they have been doing to correct the failures of TSCA.^[68]

EWG argued that CSIA was no reform protecting the general public's health, but pushed the American chemical industry's agenda with a weak safety standard.^[69] However, the EWG regarded CSIA as moving in the right direction because the EPA would have gained more authority to review existing chemicals and order companies to provide any relevant safety data about a specific chemical in question.^[69] Earthjustice further called for the final result of TSCA reform to be one that adequately protected workers continually exposed to hazardous chemicals, vulnerable populations, and communities most at risk because of high exposure to toxic chemicals.^[68]

The CSIA would have required states to co-enforce any requirements laid out by the EPA, i.e. to have funding and man-power to enforce all regulations that the EPA decided on, and causing a disconnect in partnerships between the state, federal government, and communities.^[70] There were no timelines or deadlines set in CSIA with respect to testing chemicals and putting regulatory action in place if needed; new chemicals would have been able to enter the market, and basic safety tests for new or existing chemicals would have been lacking.^[69]

The 2014 West Virginia Chemical Spill created many controversies regarding CSIA. no data on the spilled chemical were available, including data on repeated dose toxicity, carcinogenicity, reproductive toxicity, specific target organ toxicity, and repeated exposure.^[71] On February 4, 2014, the Senate Committee on Environment and Public Works held hearings on the CSIA right after the incident.^[72] In the aftermath of the spill, the House approved a bill 95-0 which provides safeguards for chemical storage tanks and public water supplies. It included new requirements on early detection technology and plans that protect against drinking water contamination.^[73]

The lack of attention to "hot spots" and protecting those at risk, such as workers and economically disadvantaged communities has been a main concern of many environmental justice groups.^[68][69][74] These "hot spots" have been the most at risk to various chemicals and their cumulative effects and have largely been neglected by past regulations from TSCA and CSIA does little to repair the situation. While CSIA would call for an analysis of all existing chemicals, the chemical testing procedures available today would still take decades to analyze all of the existing chemicals in the industry. In the meantime, CSIA would not provide any solutions to health problems for populations in these "hot spots" while potentially toxic chemicals already in use are being screened.

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,^[75] the Chicago Tribune, the American Alliance for Innovation,^[76] the International Association of Machinists and Aerospace Workers, North America's Building Trades Union^[77] SMART-Transportation Division, International Association of Bridge, Structural, Ornamental and Reinforcing Iron Workers,^[78] the American College of Occupational and Environmental Medicine, the International Brotherhood of Electrical Workers^[79] and Third Way^[80][81]

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".^[82] Environmental, health and labor organizations and several states criticized it, because "it would gut state chemical regulations".,^[83] 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.^[84] 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 EPA to quickly assess the safety of more chemicals and allow new state policies.^[83]

In June 2015 the House passed H.R.2576, the TSCA Modernization Act of 2015, and was referred to the Senate.^[85] EWG criticized that it had an "untested and ambiguous safety standard", no tough deadlines for final agency action, did not provide the resources for EPA to quickly review the most dangerous chemicals, "would allow chemical companies to pay for quick reviews and approval of their favorite chemicals" and failed "to subject EPA’s chemical safety decisions to the same standard of judicial review as other EPA actions."^[86]

Chemical regulation: a comparison of US and European approaches

Like 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.^[18]

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.^[87] 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 .^[87] TSCA requires chemical companies to submit to EPA any available human health and environmental data on the existing chemicals.^[18] TSCA does not require chemical companies to test toxicity tests for new chemicals on their effects on human health or the environment,^[18] but the companies can perform test on voluntary base.^[88] 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 EPA.^[89] In order to compensate the gap of actual test data in section 5, a process involving structure-activity relationship (SAR) was created to assess hazardous risks.^[26] As a consequences, EPA receives toxicity data less than 50 percent on new chemicals on human health and 10 percent less data on environment.^[90] 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.^[18] EPA compares new and existing chemicals by their molecular structures in order to determine if any health and environmental effects are available.^[18] Authorized by TSCA section 8(d), EPA “may” require manufacturers and importers of a given chemical to submit copies of unpublished health and safety studies including the chemicals produced in the ten years before the effective date of the EPA rule.^[88]

Under REACH and European Chemicals Agency 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 for both existing and new chemicals.^[18] 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.^[91] 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.^[92] 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.^[91]

TSCA and REACH regulations on potential chemical risks

Under TSCA, EPA needs to collect data to assess the potential risks of chemicals and requires developing substantial evidence in order to withstand judicial review and policy making.^[18] Due to the section 6(a) of TSCA, EPA has difficulty proving that certain chemicals pose unreasonable risks.^[89] In order to regulate those chemicals, EPA must find reasonable basis including the effects of substance on human and environment, magnitude of exposure, benefits and uses of the chemical, and availability of the substance.^[21] EPA also needs to determine the reasonably ascertainable economic consequences of the rule, after considering the effect to the national economy and businesses.^[21] However, the section 6 is taken into consideration to amend in the 2013 reform.^[72] Section 6 also limits or restricts the production of polychlorinated biphenyls, fully halogenated chlorofluoroalkanes, dioxin, asbestos, nitrosating agents, and hexavalent chromium.^[21] 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.^[21] TSCA also utilizes different models such as ecological risk assessment, quotient method for exceeding measurement endpoints,^[90] exposure assessment, PMN, assessment dose-response assessment, etc.^[17]

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.^[18] The authorization procedure involves first, the European Chemicals Agency to publish a candidate list of chemicals, secondly, the European Commission to 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.^[18] If the chemical company can demonstrate the social and economic benefits outweigh the risks, the harmful chemical may be able to get authorization.^[18] 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.^[18]

TSCA vs. REACH disclosing 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.^[87] TSCA allows companies to claim their precise chemical volumes, components, chemical uses, and essentially any information provided to EPA as business confidential except in the cases that chemical need health and safety studies.^[88] In this extent of TSCA, EPA’ s ability is restricted to share information including the company’s identities, the chemical’s structures to any public groups except the designated contractors, or to law enforcement officials.^[89] It is important that the state and local environmental non-governmental 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. However, EPA can only disclose confidential business information when it determines such disclosure is necessary to protect human health or the environment from an unreasonable risk.^[18]

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.^[18] Also one of the main strength of REACH is in the extent to which the government intends to make the public receive as much as information possible, including identification of substances of a very high concern that are subject to authorization.^[89] 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.^[91] PBTs (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.^[91] Therefore, the downstream users, manufacturers, retailers and importers will have the information they need to safely use and handle the chemicals.^[93] 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.^[18]

Comparison of TSCA and REACH’s selected provisions

Number of chemicals covered in the inventory

REACH: After enacting REACH in the European Union, the officials estimated approximately 30,000 cases that have produced or imported at a level of at least 1 metric ton chemicals.^[18]

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.^[18]

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.^[91]

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 have potential risks but are not required to conduct risk assessments.^[88]

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.^[92]

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.^[18]

Example of chemical inventories in various countries and regions

^[94]

• REACH - European Union Regulation (EC) No 1907/2006
• 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)
• For additional information on TSCA, see NTIS.

References

Sources

Notes

External links

United States environmental law Supreme Court decisions Missouri v. Holland (1920) Sierra Club v. Morton (1972) United States v. SCRAP (1973) Tennessee Valley Authority v. Hill (1978) Vermont Yankee v. NRDC (1978) Hughes v. Oklahoma (1979) Lujan v. Defenders of Wildlife (1992) United States v. Bestfoods (1998) Friends of the Earth v. Laidlaw Environmental Services (2000) SWANCC v. Army Corps of Engineers (2001) Department of Transportation v. Public Citizen (2004) Rapanos v. United States (2006) Massachusetts v. EPA (2007) National Ass'n of Home Builders v. Defenders of Wildlife (2007) Coeur Alaska, Inc. v. Southeast Alaska Conservation Council (2009) Major federal legislation and treaties Rivers and Harbors Act (1899) Lacey Act (1900) Weeks Act (1911) North Pacific Fur Seal Convention of 1911 (1911) Migratory Bird Treaty Act (1918) Fish and Wildlife Coordination Act (1934) Watershed Protection and Flood Prevention Act (1954) Clean Air Act (1963, 1970) National Environmental Policy Act (1970) Clean Water Act (1972) Federal Insecticide, Fungicide, and Rodenticide Act (1972) Noise Control Act (1972) Endangered Species Act (1973) Safe Drinking Water Act (1974) Resource Conservation and Recovery Act (1976) Toxic Substances Control Act (1976) Surface Mining Control and Reclamation Act (1977) CERCLA (Superfund) (1980) Emergency Planning and Community Right-to-Know Act (1986) Emergency Wetlands Resources Act (1986) Federal agencies Agency for Toxic Substances and Disease Registry Council on Environmental Quality Office of Surface Mining United States Environmental Protection Agency United States Fish and Wildlife Service Regulations and concepts Best available technology Citizen suit Discharge Monitoring Report Environmental crime Environmental impact statement Environmental justice National Ambient Air Quality Standards National Priorities List New Source Performance Standard Not-To-Exceed (NTE) Right to know Total maximum daily load Toxicity category rating

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