ABSTRACT

The Food and Drug Administration, under the Federal Food, Drug and Cosmetic Act and other public health statutes, is responsible for ensuring that food is safe and wholesome; human and animal drugs, biological products, and medical devices are safe and effective; cosmetics are safe; radiological products do not result in unnecessary radiation exposure; and products are honestly and informatively labeled. The center’s environmental assessment officer is responsible for coordinating National Environmental Policy Act functions. This includes the Offices of Drug Evaluation I and II, Pilot Drug, Office of Generic Drugs, and Office of Compliance. All agency actions are subject to environmental consideration. Actions are individually examined for potential environmental impact unless excluded as a class by categorical exclusion. An environmental impact statement is prepared for agency actions when the evaluation of the data in an environmental assessment leads to a finding that a proposed action may significantly affect the quality of the human environment.