Safety assessment programs for U.S. regulatory agencies: a perspective of requirements and compliance

Regulatory agencies and components within agencies in the United States have been established at different times but with the same basic charge: to protect the health and welfare of the citizenry by regulating the manufacture and use of chemicals and devices that might constitute a threat to the environment or a health hazard for individuals, groups of individuals, or the population as a whole. The character of each agency differs because of the political climate in which it has evolved, the personalities of the leadership, and the internal philosophies concerning how the agency's charge under the letter of the law should be accomplished in keeping with the congressional intent for establishment of the agency. The current safety assessment program requirements/guidelines and some aspects of their interpretation and application are discussed for the Environmental Protection Agency and for components of the Food and Drug Administration, including the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Veterinary Medicine.