Chemicals Policy in the United States—The Need for New Directions

The system for regulating toxic substances in the United States is broken. It is disjointed and reactionary, lacking in information, authority, and primary prevention. The case study of bisphenol A (BPA) demonstrates a myriad of limitations with the way we evaluate, regulate, and manage toxic substances in society. The purpose of this chapter is to provide a brief overview of the current U.S. system for regulating toxic chemicals and to identify limits in that approach with particular emphasis on BPA. It provides an overview of some of the drivers shaping new approaches to chemicals regulation and management and a framework for designing more precautionary and solutions-stimulating policies in the future. The U.S. system for regulating toxic chemicals in production systems and products is relatively complex. Different types of chemicals are regulated in various ways in the U.S. system, depending on how that chemical is being used. For example, cosmetics, chemicals used in food applications, medical devices, and pharmaceuticals are regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetics Act, and each of these types of chemical applications is regulated differently under the Act. For chemicals used in cosmetic products, the FDA has no premarket authority and can regulate a chemical ingredient only if it is mis­branded or adulterates the product. In the case of new food contact substances and uses of them (indirect food additives including chemicals that might leach out of packaging such as bottles), manufacturers are required to submit notifications, including safety data, to the FDA, except when a substance is previously regulated or considered “generally recognized as safe” because earlier evidence on that material did not indicate concerns. At the FDA, the highest evidentiary burdens are for medical devices and pharmaceuticals that have strong premarket testing requirements to ensure safety and efficacy. Chemicals in many consumer products, such as toys, are regulated by the U.S. Consumer Product Safety Commission (CPSC) under the Consumer Product Safety Improvement Act and the Federal Hazardous Substances Act.