Environmental Impact Considerations

The National Environmental Policy Act (NEPA) states national environmental objectives and imposes upon each Federal agency the duty to consider the environmental effects of its actions. NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse effects cannot be avoided, the agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a Federal Register notices also filed for comment at the Environmental Protection Agency (EPA). If the agency finds that no significant environmental effects are expected, the agency prepares a finding of no significant impact. This collection of information is used by FDA to assess the environmental impact of agency actions. The final EIS, including the comments received, is reviewed by the agency to weigh environmental costs and benefits in determining whether to pursue the proposed action or some alternative that would reduce expected environmental impact.

The latest form for Environmental Impact Considerations expires 2022-02-28 and can be found here.