Chemical Regulation:

Approaches in the United States, Canada, and the European Union

GAO-06-217R: Published: Nov 4, 2005. Publicly Released: Nov 30, 2005.

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Chemicals are used to produce items widely used throughout society, including consumer products such as cleansers, paints, plastics, and fuels, as well as industrial solvents and additives. While chemicals play an important role in everyday life, some may be harmful to human health and the environment. Some chemicals, such as lead and mercury, are highly toxic at certain doses and need to be regulated because of health and safety concerns. In 1976, the Congress passed the Toxic Substances Control Act (TSCA) in part to authorize the Environmental Protection Agency (EPA) to regulate chemicals that pose an unreasonable risk to human health or the environment. TSCA addresses chemicals that are manufactured, imported, processed, distributed in commerce, used, or disposed of in the United States and authorizes EPA to assess chemicals before they enter commerce (new chemicals) and review those already in commerce (existing chemicals). TSCA excludes certain chemical substances, including among other things pesticides that are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); and food; food additives; drugs; cosmetics or devices that are regulated under the Federal Food, Drug and Cosmetic Act (FFDCA). In this context, Congress asked that we provide comparative information on the following chemical control laws: TSCA, Canadian Environmental Protection Agency (CEPA), the current European Union legislation, and the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) as proposed. Specifically, Congress asked that we provide information on the approaches of (1) controlling chemical risks, (2) reviewing existing chemicals used in commerce, (3) assessing new chemicals, and (4) handling confidential business information.

TSCA authorizes EPA to take a number of control actions with regard to new chemicals or uses of chemicals that EPA has determined by rule are significant new uses. To control existing chemicals under TSCA, EPA must present substantial evidence that a reasonable basis exists to conclude that the chemical presents or will present an unreasonable risk to human health or the environment. The United States Court of Appeals for the Fifth Circuit has stated that EPA must consider the costs of any proposed action in evaluating what risks are unreasonable. EPA must also apply the least burdensome regulatory requirement. In contrast, under Canadian and European Union legislation the costs of various controls are to be considered in deciding the particular control action to be taken, but these costs are not factors in determining whether to control a chemical. Under TSCA, EPA is not required to systematically prioritize existing chemicals for purposes of determining their risks, although EPA relies upon mechanisms such as voluntary testing programs and advice from federal advisory groups to help ensure that it gives priority to the chemicals posing the greatest risks. Both CEPA and the proposed REACH legislation contain requirements for systematically prioritizing and reviewing existing chemicals. For new chemicals, TSCA requires that chemical companies submit for EPA's review any data already in their possession on the chemicals' health and ecological effects, potential exposures and on their physical chemical properties, with the premanufacture notice (PMN) generally required before chemical companies may manufacture the chemicals. Chemical companies generally do not have such data at the time they submit the PMN for the chemicals and are not required to develop the data unless EPA promulgates a test rule. Under REACH, chemical companies would be required to develop and submit data on the physical properties and health and ecological effects of new chemicals with the initial notification and, subsequently before the chemicals reach certain levels of production. Regarding the protection of confidential business information that is provided to the regulatory agencies, TSCA, CEPA, and the European Union current and proposed legislation have provisions for protecting such information from inappropriate disclosures, although the specifics of the protection varies. One of the objectives of the proposed REACH legislation is to make information on chemicals more widely available to the public.

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