The Toxic Chemicals Safety Act of 2010, H.R. 5820, a new bill introduced by U.S. Reps. Bobby Rush and Henry Waxman, proposes to change how chemicals manufactured or imported into the United States are regulated. The bill places the burden on chemical manufacturers to demonstrate to the U.S. Environmental Protection Agency that their chemicals are safe, replacing current law that allows chemicals into the stream of commerce until EPA demonstrates that they pose an unreasonable risk to health or the environment.

Currently, the production of chemicals in the U.S. is regulated by the Toxic Substances Control Act (TSCA) of 1976. Under this act, the EPA can limit the production or use of a chemical only after it has determined that the chemical presents an unreasonable risk of injury to human health or the environment. Unreasonable risk exists if the chemical's harm to health or environment outweighs the benefits of having a chemical in commerce. The EPA considers the effects of the chemical on human health and the environment, the benefits of the substance, the availability of substitutes and the economic consequences of a proposed use limit. If the EPA decides to regulate the chemical, it must do so using the least burdensome requirements. Since 1976, the EPA has regulated only five chemicals under the unreasonable risk standard (PCBs, chlorofluorocarbons, dioxin, asbestos and hexavalent chromium).

Problems with the TSCA have been noted, including that the "unreasonable risk" standard makes it nearly impossible for EPA to limit harmful chemicals. For example, the courts overturned the EPA's attempt to ban the use of asbestos. In contrast, governments in countries such as Denmark, Germany, Italy, the Netherlands, Norway and Sweden, which regulate chemicals differently, have successfully banned the mining, production, sale, use, import and export of asbestos. Since January 2005, the marketing and use of asbestos-containing products has been banned in the European Union.

The European Union has taken a different approach than the TSCA in the United States does. The EU's Registration, Evaluation and Authorization of Chemicals (REACH) legislation, which went into effect in 2007, puts the burden on chemical companies to demonstrate that the chemicals they put into the market are safe. Manufacturers, rather than regulating government agencies, are required to develop and share information on the effects of chemicals on human health and the environment. REACH works by requiring prior authorization from the European Chemicals Agency to use listed chemicals. Chemicals that require prior authorization include those with the potential for bioaccumulation, carcinogenicity and reproductive toxicity. An authorization is granted if the applicant can demonstrate that the risks from manufacture, use or disposal of the chemical can be controlled.

The newly-proposed U.S. bill shares some common characteristics with the EU's REACH in that it also shifts the burden to manufacturers to demonstrate safety. The proposed act provides that "the manufacturers and processors of a chemical substance or mixture shall bear the burden of proving that the chemical substance or mixture meets the safety standard." The bill also proposes to require the EPA to list 300 chemicals and make safety standard determinations for them within 18 months of the bill's passage. The first 300 chemicals are chosen based on their risk, presence in biological and environmental media, toxicity, persistence and bioaccumulation. Chemicals are removed from the list when a safety standard determination is made, and periodically new chemicals are added, evaluated and removed until all chemicals in commerce have had a safety standard determination.

The bill's proposed changes have garnered a lot of attention and the bill is expected to be reintroduced into the next session of Congress. The text can be accessed at http://tinyurl.com/TSCA-chemical-regulation.