User:Happymoshi/sandbox

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	Chapter 53 §§ 2601–2629
Legislative history
Introduced in the Senate as S. 3149 by Sen. John V. Tunney (D–CA) on March 16, 1976 Passed the Senate on March 26, 1976 (60-13) Passed the House of Representatives on July 23, 1976  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, that regulates the introduction of new or already existing chemicals. It grandfathered most existing chemicals, in contrast to the Registration, Evaluation and Authorization of Chemicals (REACh) legislation of the European Union. 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). Chemicals that are listed on the TSCA Inventory are referred to as "existing chemicals". Chemicals not listed are referred to as new chemicals. 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 research and development, and for substances regulated under other statutes such as the Federal Food, Drug, and Cosmetic Act and the Federal Insecticide, Fungicide, and Rodenticide Act. 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.

Since May 22, 2013, Senate Bill 1009 has been pending in Congress to reform TSCA, entitled the Chemical Safety Improvement Act. This would be the first major overhaul in many years.

Sections of TSCA

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.

2. History of TSCA

The Toxic Substances Control Act (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, is one of the most important pieces of legislation ever passed in the United States. It regulates new and existing chemicals in response to growing concern about unreasonable risks that chemicals pose to human health and the environment. TSCA limits the manufacture, processing, distribution in commerce, use, and disposal of chemical substances including polychlorinated biphenyls (PCBs), asbestos, radon and lead-based paint.

2.1 The 1971 Council on Environmental Quality Report

In 1971, the Council on Environmental Quality CEQ urged the Federal government to regulate chemical substances in the U.S in its report on toxic substances. CEQ explained the need for a more comprehensive chemical policy, in order to identify and control the chemicals that are being manufactured, produced, and used in the U.S economy. The Council on Environmental Quality (CEQ) made series of recommendations for enacting TSCA. They suggested that the law control what toxic substances should enter the environment because 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. In 1975, at the congressional testimony the Environmental Protection Agency EPA Deputy Administrator John Quarles made it clear why it was so important to pass TSCA, "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.” The CEQ report recommended that TSCA strengthen government oversight by requiring the following measures: First, manufacturers should notify officials when they use or produce new chemicals, or plan to sell a significant volume of old chemicals. Second, producers should test their chemicals and report data to officials on the quantities, uses, physical and biological properties, and any other information is necessary for assessing hazardous materials. Lastly, with this information, the government should disclosure any information about the health effects caused by dangerous chemicals to the public.

2.2 Congress’ Response to CEQ and the Drafting of TSCA

Three key assumption informed Congress reasoning for adopting TSCA. First, it is important to be proactive in understanding toxic substances and use preventive measures to limit the risks that chemicals pose to human health and the environment. Second, toxic risk should be approached in “holistic rather than fragmented" manner. Third, it is important to collect as much information as possible about toxicity of chemicals and risks associated with them. The U.S Congress responded by proposing many House and Senate bills between 1972 and 1973. The Congress decided to bring the existing chemicals substance under the new law. They were aware that the cancer mortality rate had increased and recognized that the cause of the increase was because of industrial chemicals in consumer products and the environment. As a result, they became very concerned that the risks posed by chemicals were serious enough to warrant swift action to pass TSCA. Congress agreed that it was important to acquire more data on toxic substances, such as the level of toxicity and the risks chemicals pose to human health and the environment. Congress agreed with CEQ that additional authority is required to test chemicals in order to determine their effect. 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. 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. In order to increase information on chemical risks, Congress designed TSCA to empower the EPA to test the chemicals to examine their potential dangerous effect on human health and the environment. TSCA's Jurisdictional Scope is extremely broad. The law attempts to oversee many activities such as manufacturing, processing, disturbing, using and or disposing. 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." 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. 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 random monitoring and control.
• • Title IV provides similar assistance with respect to abatement of lead-based paint hazards."

2.3 Implementation of TSCA

There have been many challenges in the implementation of TSCA. First, according to Markell, Professor of Law at Florida State University, that, TSCA and existing regulation tended to have “an ―after-the-fact‖ focus” because they only protect individuals after toxic substances are released in products. Furthermore, regulation 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.[3] According to Pure Water Alternatives, in 1977, there were over 4,039,907 toxic substances in production in the U.S. Since then, the number has been growing at the rate of 6000 per-week and it is now estimated that there are more than 70,000 new chemicals registered for commercial use in the United States, 50 of which are used in quantities greater than 1.3 billion pounds. However, because TSCA only cover certain chemical substances, not all hazardous chemicals are regulated. In 1970s there were close to 62,000 chemicals in use that were covered by TSCA.. Since then the list has grown to roughly 84,000.[7]. Third, even though TSCA gives permission to EPA to test the existing chemicals through the EPA’s own rule making process, the EPA concluded that it is very costly and difficult to collect information from industries about the risks of chemicals. Therefore the required information from chemical producers is limited to: Chemical identities, names, and molecular structures, Categories of use, Amounts 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. Even though EPA is supposed to require testing if chemicals being produced in substantial quantities. EPA relies on industry chemicals testing if it suspects that the manufacturing, production or use of a chemical can pose a serious danger to public health. The EPA must ask chemical companies to do the test either according to (1) mutual agreement or (2) voluntary industry efforts under the HPV Challenge Program. EPA's came up with the Sustainable Futures (SF) Initiative model that allows the companies to do a voluntary test of their product for any potential risk that might pose the human health and environment. This initiative is supposed to help to reduce the risk, produce safer chemicals in short amount of time, and to save money. It intends to yield better results in bringing safer chemicals into the market.

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.

Regulation of existing chemicals

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 not considered an "unreasonable risk." This gap in testing effectively grandfathered these chemicals into the TSCAs existing chemicals list. Testing and research on these chemicals is virtually non-existent, with only 200 of the more than 60,000 existing chemicals tested directly by the EPA.

The EPA has had only limited success controlling the chemicals they have tested and deemed dangerous to the public health. In fact, the agency has been successful in restricting only five chemicals (PCBs, chlorofluorocarbons, dioxin, asbestos, and hexavalent chromium) in its 35 year history, and the ban on asbestos was overturned in 1991. 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.

Regulation of new chemicals

The EPA has a better record when regulating newly created chemicals. Companies must first notify the EPA of their intention to manufacture a new chemical not listed in the 1976 act by using a Pre-Manufacturing Notice (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 prevent an unreasonable risk." If the EPA does not act to block manufacture of the new chemical within ninety days, or the EPA passes the product, the chemical may be legally marketed.

Criticisms of the TSCA

The EPA's use of the TSCA to regulate dangerous chemicals is seen as a failure by many, including the EPA's Office of the Inspector General, who called the bill "inconsistent and presents a minimal presence." in a report dated February 17, 2010. The agency also criticized the process by which the EPA handles new TSCA cases in the same report, claiming it is "predisposed to protect industry information rather than to provide public access to health and safety studies." The report further acknowledges that trade secrets are 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."

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. 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.

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 sets of requirements to the individual states where the companies do business.

For additional information on TSCA, see NTIS.

2013 Reform Bills and Preemption Controversy

In May 2013, efforts to revamp TSCA were introduced in the U.S. Senate. Senate Bill 1009, introduced by Senators Vitter (R-LA) and Lautenberg (D-NJ), and co-sponsored by a number of Senators. This would be the first major overhaul of the act in many years.

Some environmental and victim's groups however are highly critical of the bill as Section 15 contains broad language that may preempt all state personal injury or environmental litigation relating to any chemical listed on the registry.

Example of chemical inventories in various countries and regions

• Verordnung (EG) Nr. 1907/2006 (REACH)
• 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)

References

Sources

• U.S. Environmental Protection Agency, "Summary of the TSCA law and regulations".
• U.S. Environmental Protection Agency, "Announcement of agreement with General Electric to conduct Hudson River dredging", October 6, 2005.
• Schapiro, Mark, "New Power for 'Old Europe'". The Nation, December 27, 2004, 11-16.

Notes

External links

• Text of Toxic Substances Control Act
• National Technical Information Service

Shwesin Thein (Happymoshi)

2. History of TSCA

The Toxic Substances Control Act (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, is one of the most important pieces of legislation ever passed in the United States. It regulates new and existing chemicals in response to growing concern about unreasonable risks that chemicals pose to human health and the environment. TSCA limits the manufacture, processing, distribution in commerce, use, and disposal of chemical substances including polychlorinated biphenyls (PCBs), asbestos, radon and lead-based paint.

2.1 The 1971 Council on Environmental Quality Report

In 1971, the Council on Environmental Quality CEQ urged the Federal government to regulate chemical substances in the U.S in its report on toxic substances. CEQ explained the need for a more comprehensive chemical policy, in order to identify and control the chemicals that are being manufactured, produced, and used in the U.S economy. The Council on Environmental Quality (CEQ) made series of recommendations for enacting TSCA. They suggested that the law control what toxic substances should enter the environment because 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. In 1975, at the congressional testimony the Environmental Protection Agency EPA Deputy Administrator John Quarles made it clear why it was so important to pass TSCA, "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.” The CEQ report recommended that TSCA strengthen government oversight by requiring the following measures: First, manufacturers should notify officials when they use or produce new chemicals, or plan to sell a significant volume of old chemicals. Second, producers should test their chemicals and report data to officials on the quantities, uses, physical and biological properties, and any other information is necessary for assessing hazardous materials. Lastly, with this information, the government should disclosure any information about the health effects caused by dangerous chemicals to the public.

2.2 Congress’ Response to CEQ and the Drafting of TSCA

Three key assumption informed Congress reasoning for adopting TSCA. First, it is important to be proactive in understanding toxic substances and use preventive measures to limit the risks that chemicals pose to human health and the environment. Second, toxic risk should be approached in “holistic rather than fragmented" manner. Third, it is important to collect as much information as possible about toxicity of chemicals and risks associated with them. The U.S Congress responded by proposing many House and Senate bills between 1972 and 1973. The Congress decided to bring the existing chemicals substance under the new law. They were aware that the cancer mortality rate had increased and recognized that the cause of the increase was because of industrial chemicals in consumer products and the environment. As a result, they became very concerned that the risks posed by chemicals were serious enough to warrant swift action to pass TSCA. Congress agreed that it was important to acquire more data on toxic substances, such as the level of toxicity and the risks chemicals pose to human health and the environment. Congress agreed with CEQ that additional authority is required to test chemicals in order to determine their effect. 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. 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. In order to increase information on chemical risks, Congress designed TSCA to empower the EPA to test the chemicals to examine their potential dangerous effect on human health and the environment. TSCA's Jurisdictional Scope is extremely broad. The law attempts to oversee many activities such as manufacturing, processing, disturbing, using and or disposing. 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." 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. 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 random monitoring and control.
• • Title IV provides similar assistance with respect to abatement of lead-based paint hazards."

2.3 Implementation of TSCA

There have been many challenges in the implementation of TSCA. First, according to Markell, Professor of Law at Florida State University, that, TSCA and existing regulation tended to have “an ―after-the-fact‖ focus” because they only protect individuals after toxic substances are released in products. Furthermore, regulation 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.[3] According to Pure Water Alternatives, in 1977, there were over 4,039,907 toxic substances in production in the U.S. Since then, the number has been growing at the rate of 6000 per-week and it is now estimated that there are more than 70,000 new chemicals registered for commercial use in the United States, 50 of which are used in quantities greater than 1.3 billion pounds. However, because TSCA only cover certain chemical substances, not all hazardous chemicals are regulated. In 1970s there were close to 62,000 chemicals in use that were covered by TSCA.. Since then the list has grown to roughly 84,000.[7]. Third, even though TSCA gives permission to EPA to test the existing chemicals through the EPA’s own rule making process, the EPA concluded that it is very costly and difficult to collect information from industries about the risks of chemicals. Therefore the required information from chemical producers is limited to: Chemical identities, names, and molecular structures, Categories of use, Amounts 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. Even though EPA is supposed to require testing if chemicals being produced in substantial quantities. EPA relies on industry chemicals testing if it suspects that the manufacturing, production or use of a chemical can pose a serious danger to public health. The EPA must ask chemical companies to do the test either according to (1) mutual agreement or (2) voluntary industry efforts under the HPV Challenge Program. EPA's came up with the Sustainable Futures (SF) Initiative model that allows the companies to do a voluntary test of their product for any potential risk that might pose the human health and environment. This initiative is supposed to help to reduce the risk, produce safer chemicals in short amount of time, and to save money. It intends to yield better results in bringing safer chemicals into the market.