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Unit 6: Risk, Exposure, and Health // Section 10: Major Laws


The main U.S. law regulating exposure to hazardous materials is the Toxic Substances Control Act (TSCA), passed in 1976. The law authorizes the Environmental Protection Agency to regulate chemical hazards, from warning labels to outright bans. It also allows the EPA to require companies to perform extensive health and safety testing on chemicals before they can be marketed, to maintain detailed records, and to report on how chemicals are used in commerce and industry. The EPA is required to take swift regulatory action if it finds that a chemical is likely to cause cancer, gene mutations, or birth defects.

There are important limitations to the EPA's ability to regulate the chemical industry under TSCA. First, the burden of proof falls more heavily on the EPA than on chemical manufacturers. The EPA has to have "substantial evidence" of "unreasonable risk" to require testing. Out of the tens of thousands of chemicals in commerce, the EPA has only banned a handful under TSCA. Second, the agency is required to analyze risks and benefits of all less burdensome regulatory alternatives before banning chemicals. The EPA also must evaluate the risk posed by substitute products.

Several other laws regulate specific classes of hazardous substances. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) gives the EPA authority to control pesticides. All pesticides used in the United States must be registered with the EPA after they have been through health and safety testing, and users must take examinations to earn certification as applicators of pesticides. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the Food and Drug Administration regulates substances such as food additives and colorings, prescription drugs, and cosmetics.

In 1996 the U.S. Congress unanimously passed the Food Quality Protection Act (FQPA), which provides amendments to both FIFRA and FFDCA. Key provisions of FQPA under FFDCA include use of an additional 10-fold uncertainty factor to account for increased susceptibility of children and a requirement for regulators to consider aggregate exposures from multiple pathways (e.g., food, water, yards, pets, etc.) for pesticides with a common mechanism of toxicity (i.e., for organophosphates such as malathion and chlorpyrifos or for pyrethroids such as permethrin and resmethrin) in establishing allowable pesticide residue levels in food.

After three years of consideration, debate, and lobbying, the European Union's far-reaching regulation on chemicals, REACH, went into effect on June 1, 2007. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is an aggressive law that places priority on protecting health and the environment. The newly established European Chemicals Agency, located in Helsinki, will begin an 11-year process of registering some 30,000 chemical substances in use today. The agency will conduct evaluations, including risk management, to identify gaps in information about hazards, exposure pathways, and health and ecological impacts. REACH is designed to reduce harmful substances in products and the environment and to strongly encourage chemical producers and manufacturing companies to find alternative formulations, processes, and products.

The European market is important to the U.S. chemical industry, which exports some $14 billion worth of products each year. U.S. manufacturers and the federal government opposed many aspects of REACH, but companies doing business with EU countries will have no choice but to comply. The U.S. chemical industry is already providing workshops and other assistance for producers to comply with REACH. Although this process is likely to be long and expensive, it will help to harmonize national regulations for the chemical industry—a positive development, since many hazardous chemicals are produced and distributed worldwide.

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