The National Environmental Policy Act of 1969 (NEPA) requires all agencies of the Federal Government to take, to the fullest extent possible, environmental considerations into account in the planning and making of their major and final agency decisions. In a manner that is consistent with the Food and Drug Administration's authority under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and with its NEPA-implementing regulations in 21 CFR 25, the agency assesses, as an integral part of its decisionmaking process, the environmental impacts of its actions and ensures that the interested and affected public is informed of environmental analyses. Such actions include approval of a food additive, color additive, or (Generally Recognized as Safe) GRAS affirmation petitions, the granting of a request for exemption from regulation as a food additive under 21 CFR 170.39, or allowing a notification submitted under 21 USC 348(h) to become effective.
All applications or petitions requesting major and final agency action ordinarily require the submission of an environmental assessment (EA) unless the proposed action is one of a specific class of actions that qualifies for exclusion from the need to prepare an EA. For CFSAN, categorically excluded actions are listed at 21 CFR 25.32. Actions that do not qualify for categorical exclusion must contain an adequate EA. The agency determines whether information in an EA supports a decision that no significant environmental impact is reasonably expected; if so, then the agency prepares a Finding of No Significant Impact (FONSI). The agency may prepare supplements to EAs and to claims of categorical exclusions if more evidence is needed to support a decision. If evaluation of information or data in an EA, or in other sources available to the agency, leads to a finding that a proposed action may significantly affect the quality of the human environment, then the agency prepares an Environmental Impact Statement (EIS).