TSCA Chemical Reform and Operations - Essay Example

TSCA Chemical Reform and Operations: Badria Almurshidi, Lindsay Denluck, Holly Dixon, Natalie Hambalek, Cassie Nix, Delia Negru March 16, Introduction President Gerald Ford signed the Toxic Substances Control Act (TSCA) into law in 1976. It regulates the manufacture, transport, import, export, use, and disposal of chemicals known to present a risk to human health. No reforms or modifications to TSCA have been made in the 39 years since its implementation, leading to confusion and uncertainty as technology and industry modernizes. In 2010, the Society of Toxicology formed a task force with the goal of reforming TSCA to reflect contemporary standards and needs. As of March 2015, that task force has made no progress with every bill presented to Congress resulting in an impasse and failing to garner bipartisan support. However, the Congress has received two bills addressing TSCA reform and will deliberate on them soon. Here, TSCA is compared to chemical regulations in other nations, and arguments for and against its reform are presented. Chemical safety in the United States has garnered bipartisan support. Currently, there are two pieces of legislation introduced to Congress that address TSCA reform: the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act, drafted by Senators Barbara Boxer and Edward Markey, and the Frank R Lautenberg Chemical Safety for the 21st Century Act, drafted by Senators David Udall and Tom Vitter. Each bill distributes the priorities of the EPA in different ways. The Boxer and Markey legislation prioritized public health, required the EPA to review chemicals more quickly, and ensured that the EPA’s chemical assessments were aligned with the recommendations of the National Academy of Sciences. Boxer and Markey’s bill would also preserve the states’ authority to restrict chemical use and enforce federal restrictions under state law. On the other hand, the language of the Vitter and Udall bill appears to favor industry, allowing the EPA up to seven years to review each substance (Chemical Watch 2015). Although the future of chemical reform in the United States is uncertain, these two bills addressing the need for TSCA reform are certainly a step in the right direction. History and Implementation of TSCA In the early 1970’s, there was increasing concern about industrial compounds and their potential adverse effects on the environment and human health. Research on industrial substances and potential harmful effects, such as fluorocarbons found in aerosols and their effects on the earth’s stratosphere were well underway (Markell 2010). Bischloromethylether (BCME), polybrominated biphenyls (PBBs), as well as polychlorinated biphenyls (PCBs) was ubiquitously occurring in the environment, yet there was little understanding of the ramifications of their widespread use (Markell 2010). In addition, vinyl chloride, a material used extensively in the plastic industry, was found to cause a rare form of liver cancer that led to the deaths of 15 Americans (EPA 1975). At the time, an estimated 600 new chemical compounds were being introduced annually in the United States for commercial use, with no federal law in place to expansively deal with toxic substance issues (GAO 2006). With the Clean Air Act and the Federal Water Pollution Control Act already in place dealing with toxic substances in emissions and effluents, there became an apparent need for comprehensive regulatory action of toxic substances. In 1971, the Council on Environmental Quality (CEQ) published a report that pressed the federal government to move forward with toxic substance regulation. In the report, they recommended that Congress create legislation that properly identifies and controls chemicals that are manufactured, produced, and used in the United States economy (Schierow 2009). Congress agreed with the report from the CEQ in that federal oversight was required in testing and determining effects. Along with this report, policy makers were becoming increasingly aware of the correlations between cancer mortality rates and increased industrial contamination. Because of these concerns, they responded to the CEQ recommendations by proposing various related bills to both the House and Senate between 1972 and 1973 (Schierow 2009). In 1974, former Deputy Administrator for the Environmental Protection Agency (EPA), John R. Quarles, publically expressed the urgency for legislation that took a preventative approach to controlling toxic substances (EPA 1975). While there was some authority in place to control the production of certain categories of toxic substances, including drugs, food additives, and pesticides through the Food and Drug Administration (FDA), most federal enforcement was designed to prevent harmful exposure only after the substances were allowed to be introduced commercially. Quarles testified that although there would be high industry cost of premarket testing when placed in perspective with the sales and profits, the costs would be relatively modest (EPA 1975). Consensus was growing to evaluate new chemicals carefully before they were produced in mass quantities, and these preventative measures for toxic substances benefit environmental and human health. California Democratic Senator, John V. Tunney, introduced the initial bill to the United States Senate on March 16th, 1976, and on October 11th during the same year, he TSCA was signed into United States law by President Gerald Ford. TSCA authorized the EPA to regulate the chemical industry directly by governing the manufacture, importation, processing, distribution, use, and disposal of chemical substances. Furthermore, TSCA gave the EPA the authority to require companies to test existing and new chemical substances or mixtures for possible adverse effects on both the environment and human health. TSCA requires the EPA to identify, compile, update, and publish the TSCA Inventory. This inventory is a list of all chemical substances manufactured, processed, or imported for commercial purposes. Russel Train, administrator of the EPA when TSCA was enacted, stated that TSCA was one of the most important pieces of “preventative medicine” legislation ever passed by the United States Congress (EPA 1976). The implementation of TSCA did not go without challenges. Implementing TSCA proved to be difficult because of the massive number of chemicals in the United States market. TSCA “grandfathered” in an estimated 62,000 chemicals existing prior to TSCA, allowing these substances to remain on the market without assessing toxic effects (Schierow 2009). However, all new chemicals would be subject to review for both health and environmental risks. All substances that are subject to TSCA evaluation but are not listed on the 1975 inventory are considered new and must undergo review. Subsequently, the EPA heavily relies on the manufacturing industries to test suspect chemicals and comply with TSCA mandates. TSCA regulates chemicals that were not previously controlled by other US regulatory statutes that already regulated foods and food additives, pesticides, pharmaceuticals, or cosmetics. Prior to 1976, chemicals that fell out of these areas went largely uninspected (Lohmann 2013). TSCA allows the EPA to regulate the addition of new chemicals into the market by requiring an industry to undergo a system of review. Industries seeking to manufacture a product with a new chemical are obligated to inspect the TSCA inventory and determine if the chemical in question is already in existence. Today, there are approximately 84,000 chemicals listed in the inventory. If a chemical is not listed, it is considered new, and industries are required to go through the Premanufacture Notice (PMN) process, by submitting a notification with information on the chemical’s name, physicochemical properties, toxicity, and intended use (EPA 2014). Potential toxicity is generally determined by comparing the new chemical to similar chemicals already in use, rather than requiring industries to conduct laboratory toxicity testing. After receiving the PMN, the EPA is allowed ninety days to review this information and determine whether the chemical is safe for use. The EPA may extend the ninety-day period only if the new chemical is deemed harmful to humans or the environment (Vogel 2011). Advantages and Disadvantages of TSCA The implementation of TSCA in 1976 had the principle advantage of granting the EPA permission to regulate and maintain information on chemical substances. A noticeable benefit is the regulation of chemicals that would otherwise go unregulated, further improving the United States’ standards for human and environmental health and safety. TSCA not only allowed the EPA to gather information and carry out risk assessment of chemicals, but also to prohibit, control, and restrict the use of chemicals that pose a significant threat to our safety (Vogel 2011). By doing this, many chemicals are investigated by the EPA before they reach the market, which is an accomplishment and advancement over previous regulation of these substances. Despite its accomplishments, critics of TSCA have argued that it has many problems and does not adequately protect human health and environmental safety (Lohmann 2013, Vogel 2011). One of its flaws is that it assumed the 62,000 chemicals that were already in existence to be safe for continued use in industry, with additional testing or governance. In doing so, it essentially granted these chemicals an exemption from regulation, thus raising the possibility of harmful, noxious, chemicals to be used continually, with unknown effects to human health. Furthermore, many of these chemicals are classified as persistent organic pollutants (POPs), and are still being allowed on the market (Lohmann 2013). This grants the possibility for continued use of chemicals with teratogenic properties without scrutiny by the EPA (Birnbaum 2010). Chemicals that were in use before the enactment of this legislation, are thus considered safe, and it is the responsibility of the EPA to demonstrate any possible health or environmental risks, which has proven to be a difficult task (Vogel 2011). The height of TSCA’s shortcomings and limitations were apparent in the difficulties the EPA faced when attempting to ban all uses of asbestos, a chemical known to have adverse effects on human health (Vogel 2011). Asbestos, a group of fiber-forming minerals used in the construction and automotive industries, can be inhaled or consumed in contaminated drinking water and cause various cancers or other asbestos-related diseases. Exposed workers in industries that use asbestos can even transport microscopic fibers on their clothing, consequently putting their families at risk (Janssen 2010). Beginning in 1979, in attempt to prohibit most uses of asbestos, the EPA began a ten-year investigation of asbestos-related risks, which culminated in 100,000 pages worth of studies (Janssen 2010, Vogel 2011). Despite this, industry brought the EPA to court. The court ruled that new uses of asbestos would be banned, but allowed the continued use of asbestos in products that already contained it because they determined that the EPA did not have enough evidence to show that there was “unreasonable” risk involved with the continued use of asbestos. This example shows the difficulty the EPA faces when attempting to take a substance off the market (Vogel 2011). Certain industries, particularly those associated with construction and automobiles, continue to use asbestos to this day (Janssen 2010). Other than the EPA, The National Institute of Health’s (NIH) National Toxicology Program and the International Agency for Research on Cancer (IARC) also identify asbestos as a carcinogenic compound (Janssen 2010). TSCA does not give the EPA enough authority to take a harmful chemical off the market in a timely manner. Another drawback to TSCA is its lack of regulations on testing and investigating potential synergistic effects of multiple chemicals. The PMN process to allow a new chemical on the market focuses on determining whether one chemical, on its own, has adverse effects on human health and the environment. In reality, people are continuously exposed to a complex mixture of chemicals. Recent studies have demonstrated that chemicals mixed together at concentrations below their no observed effect concentrations (NOEC) can interact synergistically to produce significant harmful health effects. Unless the EPA is able to investigate chemical mixtures, there is not enough information on how the chemicals could affect humans and the environment if compounds are examined on an individual basis. (Lohmann 2013). Introduction and History of REACH It took over 30 years for the European Union (EU) to develop stricter regulations on Chemical use. In June 2007, the EU proposed legislation to improve their former regulatory framework for chemical use, called the Regulation on Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). It was implemented in the EU as well as in Iceland, Liechtenstein and Norway (International Trade Administration, 2013). REACH is considered the most wide-ranging and costly regulatory initiative related to health risk assessment (Williams, Panko, & Paustenbach, 2009). Contrary to the TSCA legislation in the U.S., REACH legislation of Europe embraces the precautionary principle, whereby potential hazards of chemicals must be tested before going to market and places the burden of compliance on industry rather than regulators. This requires companies manufacturing and selling chemicals in the EU to demonstrate their safety through an expensive, but thorough registration process (Williams et al., 2009). REACH was implemented due to concerns about the large number of substances manufactured and placed on the market despite insufficient information on the hazards they could pose to human health and the environment (European Commission, 2013). With little toxicity information available and considerable public pressure, the EU saw development of REACH as a necessary responsibility to fill these gaps and to provide sufficient data for chemicals already on the market, new chemicals, and those that are imported into the EU. To fill these informational gaps, REACH requires industry to provide the appropriate safety information on a chemical and to implement protective practices for environmental and human health. This includes extensive chronic toxicity testing on vertebrates, especially with reproductive endpoints, extending out to the second generation (Hartung & Rovida, 2009). The European Commission states that “all manufacturers and importers of substances have a general obligation to submit a registration to the European Chemicals Agency (ECHA) for each substance manufactured or imported in quantities of one ton or more per year per company” (European Commission, 2013). Exceptions to this rule include chemicals imported into the EU or manufactured in quantities below one ton, chemicals used for research and development, chemicals whose uses are covered by other EU legislation, and waste (International Trade Administration, 2013). The ECHA, located in Helsinki, Finland manages the databases, coordinates the in-depth evaluation of suspicious chemicals and is currently building a public database for easy reference. Once registration is received and approved by the ECHA, the substance is evaluated in terms of quality measures in order to ensure its safety for human life and the environment. (European Commission, 2013). Typically, the ECHA makes a decision to move the substance forward to the authorization step; however, if there is insufficient data or if the data conflicts, the substance in question is reviewed by the European Commission and suggestions are made for additional examinations and compliance (European Commission, 2013). After the registration and evaluation steps, the substance can be either authorized for use on the market or placed on a Candidate list and is eventually included in Annex XIV of the REACH Regulation (European Commission, 2013). Once included, they cannot be placed on the market or used after a fixed date unless the company is granted an authorization. REACH also includes a restriction process for substances of very high concern if they pose an unacceptable risk to health or the environment. These substances may be limited or banned, if necessary, and include substances such as POPs, PCBs, and DDT. The implementation of REACH and its precautionary approach has demonstrated influence on the global community. The ‘guilty until proven innocent’ approach in terms of chemical regulation has inspired China to develop its own version of REACH, in the form of the ___?. Substances evaluated under REACH will improve understanding of the potential health and environmental risks regarding these chemicals. However, the cost and resources of obtaining additional toxicological information may or may not provide long-term benefits that outweigh the costs of regulatory compliance. Comparison between TSCA and REACH TSCA and REACH are both directed at obtaining scientific data related to chemical substances to provide humans and the environment with improved safety and protection (Searles, 2011). However, the two substantially differ in their respective approaches of collecting the required data and supply chain obligations. Provisions under REACH provide a solution for some of the long-standing complications traditionally faced under TSCA as well as under the European chemical legislation preceding it. The range of data required by REACH is broader compared to that required by TSCA. TSCA and REACH have very different requirements for chemical information disclosure. TSCA requires the EPA to protect the confidentiality of the chemical information released to them. . The EPA is restricted to only releasing to the public or to law enforcement officials the identity of the company and the structure of the compound (Denison 2009). The EPA may only disclose chemical information when it has been deemed necessary for the protection of the environment and human health. On the other hand, REACH makes information related to health and safety publicly available. REACH requires the government to compile and maintain this information, however, REACH does not report the full chemical composition, its preparation, use, and detailed application, the precise volume that is manufactured, the manufacturers’ relationship, downstream users, or importers. These data are kept confidential for proprietary reasons (Rude and Hansson, 2010). Unlike TSCA, REACH is able to share chemical information of a company with government and state authorities as long as an agreement is reached. TSCA and REACH fundamentally differ in their approach to the regulation of chemicals (Applegate, 2008). Unlike TSCA, REACH mandates evidence of safety for all chemicals manufactured or imported in volumes greater than 1 tonne, including those that were in use prior to its implementation. While TSCA ignores existing chemicals by subjecting only new chemicals to a screening procedure, REACH revisits existing chemicals by “implement[ing] a step by step process to address the ‘burden of the past’ and develop adequate knowledge for existing substances that industry wants to continue marketing” (Texas Law Review Association, 2008, p. 1390).The number of contrasting elements between TSCA and REACH are numerous with each one addressing situations differently, though fundamentally, both are intended to promote the preservation, health, and safety of the environment and its inhabitants. Other Global Efforts for Chemical Regulation China. China has created stricter chemical regulations in recent years, and its policies appear to be modeled after REACH. The country requires an extensive chemical registration process, including hazard identification, environmental and toxicological data, and safety procedures. However, unlike REACH, China’s policies only require registration of chemicals listed in its Catalogue of Hazardous Chemicals, regardless of production and use volume. Surprisingly, and despite other shortcomings, China’s policies are considered stricter and wider in scope than the United States’ (Nature source). Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is Australia’s main chemical regulatory policy. NICNAS is responsible for identification, registration, and assessment of industrial chemicals, and its main goal is to protect human and environmental health. (Nicnas) NICNAS has been compared to TSCA, and a 2012 internal review revealed that many of its shortcomings overlapped with those identified in TSCA. However, Australia has taken steps to address these issues, by conducting internal reviews and assessing and reforming the policy (Nicnas). Arguments For and Against Reformation of TSCA In recent years, pressure has mounted to reform TSCA. Numerous groups, both industry and non-governmental organizations, have lobbied their recommendations for reform. For example, the Society of Toxicology formed a task force with the intent to review bills presented to Congress and to promote the importance of TSCA reform to its membership and Congressional staffers (SOT Source). The American Chemistry Council (ACC) provides recommendations for policymakers in the form of ten principles that they believe need to be addressed by reform (ACC Source). Keller and Heckman, a law firm with the largest chemical regulatory practice in the country, has a TSCA Reform Center dedicated to analyzing reform efforts and advising industry response (Keller and Heckman source). Other groups with similar goals exist, and each plays an important role in shaping public and political opinions on the matter. The arguments in favor of reform revolve around the reactive nature of this policy. A more proactive approach will attempt to prevent harm before it occurs, potentially save lives, preserve quality of life, and prevent environmental crises. However, arguments against a proactive approach include the expense of testing and verifying chemicals that will likely not exhibit any harmful effects. TSCA currently places the burden of proof on the EPA. If the regulatory approach were changed from proactive to reactive, this would lead to substantially higher government costs. The burden of proof may shift, as well if TSCA reform occurs, and this is debated independently. The ACC recommends the burden be shared, with industry required to provide the EPA with sufficient data, while EPA is responsible for making safe use determinations in a timely manner (Source). The placement of the burden of proof can determine the financial responsibility for testing, which is another key reform point. . It is important that policy makers and scientists recognize that reforming TSCA will have both direct and indirect significant costs. Time, human labor, and monetary cost are all critical factors to consider when reforming chemical regulations, yet it is incredibly hard to quantify the true cost of evaluating chemical safety and toxicity because of the number of factors involved. Undoubtedly, weighing the costs and benefits of chemical safety and reform will play a major role in the future of reform. When the EU enacted REACH, it was predicted that 180,000 pre-registrations would come from close to 30,000 companies on close to 30,000 chemicals (nature source). Completing all of these chemical approvals for REACH will be no small feat. Toxicologists were not immediately prepared with the time or appropriate equipment for the new REACH data collection process (nature). Additionally, the monetary costs of REACH are going to exceed original estimates. The original costs of REACH were estimated to be approximately 2.3 billion USD (Nature). With more substances pre-registered through REACH than originally expected, the 2.3 billion dollar estimate is most likely too low. It is important to note that in 2014 the EPA received 8.2 billion dollars from the federal government (EPA). TSCA reform would most likely lead to higher costs and place added stress on the EPA’s already limited funding, a prominent argument against reform. In addition to direct environmental agency costs, other economic consequences could result from reforming TSCA. More regulations on chemicals, and the potential for the burden of proof to be shared between the EPA and industry, means that businesses would have to take on higher costs to develop and sell new chemical products. This may result in giving larger businesses an unfair advantage over smaller businesses. The time and money investment required to produce a new product could be significantly higher with more regulations. Yet, as seen in the EU, businesses did not stop selling their chemical products in response to REACH (source), and instead adjusted to the new rules, which resulted in l significantly more chemical sales in the EU than predicted. An argument for reform would be to test these chemicals at different endpoints, especially at chronic toxicity endpoints to understand how these chemicals impact long-term human health. This additional testing, though, may be unnecessary as these chemicals have been on the US market for several decades and no major adverse health impacts have been found. Similar arguments for and against reform may also be applied to new products introduced to the market, such as those manufactured using nanotechnology. In the case of nanotechnology, TSCA’s regulations may be too antiquated to evaluate these new products and technologies properly. It is so because nanotechnology is a new technology that requires advanced equipment and skills to evaluate. An important argument for added TSCA regulations is that other chemical regulatory frameworks like REACH are filling large data gaps on human toxicity and environmental persistence. Although a proactive approach would result in an increase of the number of animals used for toxicity testing, various methods may reduce the number of animals used . For example, REACH utilizes different consortia to facilitate animal research data sharing between companies so animal testing can be reduced to a minimum. Another strategy would be to reduce the number of animal tests done on second-generation organisms. Another argument for TSCA reform is that companies cannot always be trusted to make the right decision for human and environmental health. For example, McNeil Consumer Healthcare, the maker of Tylenol was just fined 25 million dollars for selling medicine that they knew contained metal particles (NYT). The company was aware of this metal contamination for over a year before the medicine was recalled (NYT). In contrast, it can be argued that a sufficient burden of proof is already placed on companies because they do not want to sell products that will harm the consumer. Selling dangerous products will only come back to financially hurt the company, giving them a strong incentive to conduct adequate toxicity testing before bringing a product to the market. Due to this, added TSCA regulations may not lead to any cost-effective, long-term differences. In addition to chemical test requirements, there are also arguments for and against reforming TSCA regarding the dissemination of toxicity information. The argument against adopting a policy similar to REACH, which does disseminate environmental and toxicological information regardless of risk, involves proprietary protections for the business using the chemical. The construction and maintenance of such a chemical database would be useful for sharing toxicity information, but would infringe on the agency’s already limited resources and could release sensitive company information. The scientific community and the public do have an interest in such data, though. Scientists have an obligation to publish their data due to funding requirements and an ethical obligation to promote the greatest good for the scientific community. Conclusion Chemical regulation reform in the United States is needed urgently , and with two bills currently being discussed in congress, reform is eminent.. Regardless of the type of reform that occurs, it is likely to be far reaching and influenced by examples set around the globe. TSCA was implemented to protect environmental, ecological, and human health, and any reform efforts must be made with that goal in mind. Abbreviations ACC: American Chemistry Council BCME: Bischloromethylether CEQ: Council on Environmental Quality ECHA: European Chemicals Agency EPA: Environmental Protection Agency EU: European Union IARC: International Agency for Research on Cancer NIH: National Institute of Health NOEC: No observed effect concentration PBB: Polybrominated biphenyl PCB: Polychlorinated biphenyl PMN: Premanufacture Notice POP: Persistent organic pollutants REACH: Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals SOT: Society of Toxicology TSCA: Toxic Substances Control Act References References-Natalie Chemical Watch. 2015. "Senator Boxer Introduces Counter TSCA Reform Measure." Retrieved March 14, 2015. Environmental Protection Agency. 1975. "Quarles Testifies on the Need for Toxic Substances Act.” Retrieved March 5,. 2015. 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