Overview
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, processing, distribution, use, sale, and disposal of chemicals. This act does not address pollution, which is regulated through the Clean Air Act,Sections
The TSCA is found in United States law at Title 15 of the United States Code, Chapter 53, and administered by EPA. *Title of the TSCA, "Control of Toxic Substances," is the original substance of the 1976 act, establishes the core program, including regulation of polychlorinated biphenyl (PCB) products and bans certain activities with respect to elemental mercury. *Title II, "Asbestos Hazard Emergency Response," authorizes the EPA to set standards forHistory
The TSCA was passed by the United States Congress and signed into law by PresidentThe 1971 Council on Environmental Quality Report
In a 1971 report, the Council on Environmental Quality (CEQ) urged the Federal government to regulate toxic substances in the U.S. CEQ explained that existing 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. AsCongress’ response to CEQ and the drafting of TSCA
Congress agreed with CEQ that additional authority was required to test chemicals to determine their effect, and responded to CEQ's recommendation by proposing many House and Senate bills between 1972 and 1973. Policy makers were also aware that the cancer mortality rate had increased and recognized that the cause of the increase was related to the rise of industrial chemicals in consumer products and the environment. As a result of these concerns, Congress concluded the risk of chemical exposure to the public were serious enough to warrant swift legislative action. Three key assumptions informed Congress' approach to drafting a chemicals control policy. First, in order to limit the risks that chemicals pose to human health and the environment, it would be important to be proactive in understanding toxic substances and use preventive measures. Second, toxic risk should be approached in a "holistic rather than fragmented" manner. Third, it was important to collect as much information as possible about the toxicity of chemicals and the risks associated with them. Although there was much support for policy to address public health risks from chemical exposure, the law was stalled at the last minute because of disagreement over the proper scope of chemical screening prior to commercial production. However, a series of environmental disasters, such as the Kepone catastrophe at Hopewell, Virginia,Richard FosterImplementation
There have been many challenges in the implementation of TSCA. First, according to David Markell, Professor of Law at Florida State University, TSCA and preexisting regulations have "an ―after-the-fact focus" that fails to protect individuals before toxic substances are released in products and is media focused without addressing how to control pollution within communities. Second, TSCA implementation is difficult because of the number of chemicals in the US market and high costs associated with fully assessing the toxic impacts of so many chemicals on human health and the environment. 62,000 chemicals on the market at the time were listed on the original TSCA Inventory of Chemical Substances. TSCA "grandfathered" these 62,000 chemicals, allowing these substances to remain on the market without first assessing toxic impacts. New chemicals, however, would be subject to review for health and environmental risks. Since then number of chemicals listed on the TSCA Inventory has grown to roughly 84,000. The EPA has only required approximately 200 of these 84,000 chemicals to be tested, and of the 22,000 chemicals introduced since 1976, chemical manufacturers have produced very little data for the EPA on potential health and/or environmental impacts. Third, even though TSCA gives authority 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. The EPA is authorized to require industry to perform testing of chemicals being produced in substantial quantities or if the EPA finds that the manufacturing, production or use of a chemical "may present an unreasonable risk of injury to health or the environment."15 U.S. Code Chapter 53 - Toxic Substances Control Act. Subchapter I: Control of Toxic Substances. §2603 - Testing of Chemical Substances and Mixtures. The only information required from chemical producers is chemical identities, names, and molecular structures, categories of use, amount manufactured and processed for each category of use, descriptions of byproducts resulting from manufacture, processing, use, and disposal, environmental and health effects, number of individuals exposed, number of employees exposed and the duration of exposure, and manner or method of chemical disposal. In order to obtain more information related to chemical risks, the EPA must ask chemical companies to do testing. This occurs either by (1) mutual agreement, or (2) voluntary industry efforts under theRegulation of existing chemicals
Currently existing chemicals on the market are listed in the TSCA Inventory. 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." 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 data on risk, manufacturing and processing, adverse health effects, published and unpublished health and safety studies, and "substantial risks." to the EPA Also, if a substance is subject of a Significant New Use Rule (SNUR), a company would have to submit and receive approval of a Significant New Use Notice (SNUN) prior to undertaking the significant new use(s) defined in the SNUR. Under section 4, the EPA has the authority to require manufacturers to test existing chemicals, but in each case the EPA must make several formal findings, the first of which is subject to judicial review under the "substantial evidence" standard. In particular, the requirement that the 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. This burden was one of the drivers for changes to Section 4 during the negotiations to reform TSCA. In 1989, the EPA issued a final rule under section 6 to ban the manufacturing, importing, and processing of nearly all asbestos-containing products in the USA. However, it had only limited success in using the authority granted under TSCA section 6 to control chemicals tested and deemed dangerous to public health. The EPA's failure to adequately regulate these chemicals caused strong debates over the legal burden the EPA bears in banning chemicals. The EPA has been successful in restricting five chemicals using section 6 authority (PCBs, chlorofluorocarbons, dioxin, asbestos, and hexavalent chromium) in its 38-year history, with the ban on asbestos being partially overturned in 1991. EPA has restricting some existing chemicals using Section 5 SNURs. , 250 of the more than 60,000 existing chemicals have been directly tested by the EPA. 140 of those chemicals were tested by regulatory order and 60 were tested after voluntary consent by the manufacturer. Additionally, there are 3,000 high production volume (HPV) chemicals, produced or imported in quantities exceeding one million pounds per year These HPV chemicals only constitute one third of existing chemicals, but their high volumes raise concern about the lack of basic hazard information. 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. The HPV program lead to the generation of new or release of existing data on over 2,200 chemicals.Regulation of new chemicals
Companies must notify the EPA of their intention to manufacture (or import) a new chemical (one not listed on the TSCA Inventory) by submitting a PMN at least 90 days prior to the first manufacture or import for a non-exempt purpose. Section 5 of TSCA does not require any toxicity testing before submitting a PMN 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." In order to regulate new chemicals, the EPA must determine that the chemical "...may present an unreasonable risk of injury to health or the environment..." or show that the chemical "... is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance...." If the EPA does not satisfy these requirements, it cannot act to block the manufacture of the new chemical. The 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. " From 1979 to 1994 the 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. 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. 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 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. However, it has been argued that SARs and SAT’s review process do not adequately evaluate risks associated with new chemicals. 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 chemicalsChemical Substance Inventory (TSCA Inventory)
The TSCA Chemical Substance Inventory (TSCA Inventory) is EPA's comprehensive list of confidential and non-confidential chemical substances. The non-confidential inventory is provided in Microsoft Access and CSV formats within ZIP files. Inventory notification reporting is through an updated user interface in the Central Data Exchange (CDX) Chemical Safety and Pesticide Programs (CSPP) web application for company-authorized officials and their support; there is no role for the public to access the CDX CSPP web app. The Toxics Release Inventory (TRI) is a different inventory for Superfund reporting.Criticism
TSCA had been severely criticized by non-governmental organizations, academics, scientists, and even government agencies for failing to regulate the safe use of chemicals affecting human health and environmental welfare effectively. Prior to the TSCA amendments in 2016, "the act has not been substantially updated." Organizations concerned about product safety, "including the chemical industry, environmental and public health advocates, and the EPA" 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." According to Wilson and Schwarzman, there are three gaps in US 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." The EPA Office of the Inspector General said in 2010 that implementation has been "inconsistent and presents a minimal presence." The report criticized the process by which the EPA handles new TSCA cases, claiming it is "predisposed to protect industry information rather than to provide public access to health and safety studies." GAO suggests that concern for trade secrets is preventing effective testing. In come cases, toxicity studies do not include the specific identity of the test substance and cannot report any problems because "health and safety data are of limited value if the chemical the data pertain to is unknown."State regulation of toxic substances and chemicals
Certain state governments have implemented "comprehensive regulatory programs" for stricter control on toxic chemicals as a response to the failure of Congress to modernize TSCA. Some critics of TSCA note its inability to support meaningful action to prevent a patchwork of state policies as state lawmakers in 18 states have collectively passed 71 chemical laws since 2003. 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. Critics favoring a federal reform of TSCA argue that the patchwork of state chemical management laws create "tensions between federal and state powers." Moreover, state law initiatives and rules to target chemicals have significant support from "the public demanding stricter chemical control." Stringent state laws have successfully implemented more regulation on "BPA in plastic products and food beverage containers or flame retardants in furniture." 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. 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.Chemical industry’s support for TSCA reform
In 2009, chemical manufacturers stated that TSCA needs "modernizing" 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." 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. 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. Yet, environmental groups and state agencies argue that TSCA provisions "protect confidential business information" (CBI) preventing them from accessing information relevant to their task. 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.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. 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" For better management and control of chemicals "a string of high-profile campaigns focusing on chemicals in consumer products" has made consumers aware of "chemical exposures to everyday life" 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." 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." The demand for sustainable products can force the market to adopt more green chemistry.Technological innovation and TSCA reform
Opponents to TSCA reform proposals argue that stringent legislation can be seen as "job-killing." 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 design chemicals to be less hazardous, with the goal of making chemicals and products "benign by design." see CGCI According to the Safer Chemicals, Healthy Families Coalition, "18 states have collectively passed 71 chemical laws since 2003."Chemicals, Safer. "Healthy Families/Safer States Coalitions,"Healthy States: Protecting Families from Toxic Chemicals While Congress Lags Behind," November 2010." 6 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. 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. 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." However, if the bulk form of the nanomaterial is not listed on the TSCA Inventory, the nanomaterial is a new chemical substance that is subject to pre-market review. There is not enough knowledge about the potential risk of exposure while new nano material created at a rapid rate is incorporated into consumer products without testing the toxicity risk of exposure to human health and the environment. Technological creation of new chemicals is ahead of TSCA regulation for new chemicals. The U.S. chemical industry claims having tight regulations can interfere with their ability to compete. 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. 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 theTSCA 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." Public policy can transform and empower communities "fighting environmental racism" associated with industrial facilities built near low-income neighborhoods. Communities from minority groups are disproportionately affected by "environmental threats from toxic contamination, locally unwanted land use (LULUs) to unsafe and substandard housing and natural-resource extractions" cannot wait for years until bureaucratic processes demonstrate their health has been at risk from living under these conditions. Studies have shown that "lower-income people were found to be significantly more likely than were higher income people to live near a polluting industrial facility." 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." 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. 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" 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" living in polluted neighborhoods unable to relocate to a nicer area.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." 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. This concern is reflected in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which includes a requirement that EPA evaluate risk to "potentially exposed and susceptible subpopulations."Children's exposure to toxic chemicals
Children are more susceptible to develop patterns of illness with longtime effect in their health for which chemical exposure can be contributing pediatric disease. The main health problems associated with environmental chemical pollutants are asthma,Pregnant women's exposure to chemicals
Pregnant women exposure to toxic chemicals in daily basis "can impact the reproductive and developmental health" during critical windows of development, this may lead to a higher risk for birth defects and childhood illnesses and "disability across the entire span of human life." Health professionals can provide information to women planning to become pregnant or already pregnant to avoid potential hazards and exposure to environmental toxic chemicals. Eating healthy food can reduce the impact of toxic chemicals, for instance consuming organic food. Mothers who are breastfeeding can expose their child to toxic chemicals in their milk. When the diet of children is modified from "conventional to organic food, the levels of pesticides in their bodies decline," but low-income families have to prioritize their needs and buying organic food may not be possible because of a budget constraint Readers are reminded that pesticides are not regulated under TSCA jurisdiction, rather they are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act.Occupational workers' exposure to toxic chemicals
According to theCorporate support for mitigation of toxic chemical exposure
Corporations can show social responsibility by removing products from the market and introducing similar alternatives that can benefit vulnerable groups. For instance, "Kaiser Permanente, a major medical supply purchaser, has a policy to avoid chemicals associated with cancer, reproductive problems and genetic mutations." Corporation social responsibility (CSR) is the moral obligation of the firm "to create success in ways that honors ethical values and respect to communities while promoting sustainability and a good reputation." Corporations can innovate and improve their image by responding to the increasing demand of green chemicals by consumers seeking better options to reduce their exposure to toxic chemicals.Reform bills
Prior to 2015
On May 23, 2013, Senators David Vitter (R-LA) and Frank Lautenberg (D-NJ), introduced a TSCA reform bill, co-sponsored by a number of other senators at the United States House Energy Subcommittee on Environment and Economy. The main focus of this effort was to amend TSCA's subsection S.1009, the2015
In March 2015, Senator Tom Udall (D, NM) sponsored Senate bill 697, to amend and reauthorize TSCA, called the "Frank R. Lautenberg Chemical Safety for the 21st Century Act". Environmental, health and labor organizations and several states criticized it, because "it would gut state chemical regulations"., but officials from the EPA and Administrator Gina McCarthy have testified that the bill meets all of the Obama Administration's principles for TSCA reform and that the Administrator was "encouraged" by the bipartisan progress. In addition, the Environmental Defense Fund supports S. 697, stating that it "will give heEPA the tools necessary to better ensure the safety of chemicals and significantly strengthen health protections for American families." Senate bill 725, introduced by SenatorComparison with EU chemical regulation
The European Union (EU) has enabled similar laws called Registration, Evaluation and Authorization of Chemicals (REACH) on June 1, 2007 to improve the former legislative framework on chemicals.Chemical Regulation: Comparison of U.s. and Recently Enacted European Union Approaches to Protect against the Risks of Toxic Chemicals : Report to Congressional Requesters. Washington, D.C.: U.S. Govt. Accountability Office, 2007. https://www.gao.gov/products/GAO-07-825 There are three main points to emphasize on the comparisons of REACH and TSCA.REACH vs. TSCA requirements on developing chemical information
Developing a sufficient information is important for risk management and for prevention from potential hazardous substances. Categories of information that are useful in risk management are first, scientific information including the composition of the chemical, secondly, technological information including monitoring, preventing or controlling, and finally, legal information including the rights and obligations of producers, consumers and general public . TSCA requires chemical companies to submit to the EPA any available human health and environmental data on the existing chemicals. TSCA does not require chemical companies to conduct toxicity tests for new chemicals on their effects on human health or the environment, but the companies can perform test on voluntary base.Conrad, James W. "Open secrets: The widespread availability of information about the health and environmental effects of chemicals." Law and Contemporary Problems 69 (2006) In TSCA's section 5, companies are required to submit such data if the effect already exists when they submit a premanufacture notice (PMN) to the EPA. 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.Wagner, Pauline M., J. V. Nabholz, and R. J. Kent. "The new chemicals process at the Environmental Protection Agency (EPA): structure-activity relationships for hazard identification and risk assessment." Toxicology Letters 79.1 (1995): 67-73 As a consequence, the EPA receives toxicity data less than 50 percent on new chemicals on human health and 10 percent less data on environment. TSCA also requires data on the physical and chemical properties, fate, health and environmental effects of the chemical (hazard information) that the companies possess or reasonably ascertainable when they submit the intent of manufacturing notice to the EPA. The EPA compares new and existing chemicals by their molecular structures in order to determine if any health and environmental effects are available. Authorized by TSCA section 8(d), the 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. Under REACH andTSCA and REACH regulations on potential chemical risks
Under the TSCA, the 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. Due to the section 6(a) of TSCA, the EPA has difficulty proving that certain chemicals pose unreasonable risks. In order to regulate those chemicals, the 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. The EPA also needs to determine the reasonably ascertainable economic consequences of the rule, after considering the effect to the national economy and businesses. However, the section 6 is taken into consideration to amend in the 2013 reform. Section 6 also limits or restricts the production of PCBs, fully halogenated chlorofluoroalkanes, dioxin, asbestos, nitrosating agents, and hexavalent chromium. In addition for 160 existing chemicals, under Section 5a2, TSCA requires chemical companies to submit notices to the EPA prior to manufacturing, importing, or processing of the substance for new usage. TSCA also utilizes different models such as ecological risk assessment, quotient method for exceeding measurement endpoints, exposure assessment, PMN, assessment dose-response assessment, etc.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. TSCA allows companies to claim their precise chemical volumes, components, chemical uses, and essentially any information provided to the EPA as business confidential except in the cases that chemical need health and safety studies. In this extent of TSCA, the 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. 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, the 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. 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. 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. 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. For persistent, bioaccumulative and toxic substances (PBTs), very persistent and very bioaccumulative and toxic substances (vPvB), and other chemicals that are classified as dangerous, REACH requires firms to submit a safety data sheet so that downstream users, manufacturers, retailers, and importers have the information required to safely use and handle the chemicals. 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.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. TSCA: Currently more than 82,000 chemicals are in the TSCA inventory and 20,000 of them were added after 1979 into the inventory after the EPA program started reviewing the existing chemicals.Complete risk assessment requirements
REACH requires chemical companies that produce at level of 1 metric tons per year to conduct risk assessment along withProduction quantity disclosure
REACH requires chemical companies to submit their registration yearly with the information on the overall quantity of production or importing of a chemical in metric tons per year in a technical dossier and immediately report if any significant changes occur in the quantity. TSCA: Chemical companies must provide the EPA a reasonable third year estimate for their new chemicals in total production volume at the time a Premanufacture Notices is submitted. For every 5 years, the existing chemicals on the TSCA inventory and produced at quantities of 25,000 pounds or more must be reported.Example of chemical inventories in various countries and regions
See also
* Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) - EU legislation *References
;Sources *U.S. Environmental Protection Agency (EPA)(2020-09-09)External links