Chemical Regulation: Approaches in the United States, Canada, and the European Union

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.