What 21 CFR Part 25 - FDA Environmental Impact Considerations (NEPA Implementation: Environmental Assessments, Categorical Exclusions, Environmental Impact Statements) requires
21 CFR Part 25 sets the FDA implementation of the National Environmental Policy Act of 1969 (NEPA) section 102(2) for FDA actions affecting FDA-regulated products including drugs, biologics, medical devices, tobacco products, and animal drugs. Section 25.1 establishes the purpose: NEPA directs that, to the fullest extent possible, the policies, regulations, and public laws of the United States shall be interpreted and administered in accordance with the policies set forth in NEPA; all agencies of the Federal Government shall comply with the procedures in section 102(2) of NEPA except where compliance would be inconsistent with other statutory requirements; the regulations implement section 102(2) of NEPA consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, supplementing the Council on Environmental Quality (CEQ) procedural regulations at 40 CFR Parts 1500 through 1508 and the HHS General Administration Manual Part 30 (45 FR 76519). Section 25.15 sets the general procedures: all applications or petitions requesting agency action require the submission of an Environmental Assessment (EA) or a claim of categorical exclusion; a claim of categorical exclusion must include a statement of compliance with the categorical exclusion criteria and that no extraordinary circumstances exist. Section 25.20 lists FDA actions normally requiring at least an EA. Section 25.21 requires at least an EA where extraordinary circumstances indicate the action may significantly affect the human environment, including actions for which available data show potential for serious environmental harm at the expected exposure level, and actions that adversely affect a species or critical habitat under the Endangered Species Act or CITES, or wild flora or fauna with special Federal protection. Section 25.22 governs Environmental Impact Statements (EISs): there are no categories of agency actions that routinely significantly affect the human environment requiring an EIS; an EIS is prepared when EA evaluation or other information leads the responsible agency official to a finding that the action may significantly affect the human environment. Subpart C lists categorical exclusions: Section 25.31 lists human drug and biologic categorical exclusions including NDA, ANDA, biologic product marketing approval, and OTC monograph actions where the action does not increase use of the active moiety, where the estimated concentration at the point of entry into the aquatic environment will be below 1 part per billion, or where the substance occurs naturally in the environment without significant alteration. Section 25.40 sets the form and content of EAs (drawing on 40 CFR 1508.9 - a concise public document providing evidence and analysis for the agency to determine whether to prepare an EIS or a Finding of No Significant Impact (FONSI), including brief discussions of the need for the proposal, alternatives as required by NEPA section 102(2)(E), environmental impacts of the action and alternatives, and a list of agencies and persons consulted). Section 25.52 governs FDA EISs - if FDA determines that an EIS is necessary for an action involving investigations, approvals, or market authorizations for drugs, animal drugs, biologic products, devices, or tobacco products, an EIS will be prepared but will become available only at the time of approval or market authorization, and otherwise conforms to the requirements at 40 CFR Parts 1502 and 1506.6(f).
Pillar: Medical & Healthcare · Authority: United States Food and Drug Administration, Department of Health and Human Services, implementing the National Environmental Policy Act of 1969 (NEPA) section 102(2) under 42 USC 4321 et seq., the Federal Food, Drug, and Cosmetic Act under 21 USC 321-393, and the Public Health Service Act under 42 USC 201 et seq.; codified in the Code of Federal Regulations Title 21 Part 25 and maintained on a current basis by the Office of the Federal Register · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-25
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- 21 CFR 25.1 - Purpose - NEPA section 102(2) directs all Federal agencies to comply with the procedures except where compliance would be inconsistent with other statutory requirements; Part 25 implements NEPA section 102(2) consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, supplementing CEQ regulations at 40 CFR Parts 1500-1508 and HHS General Administration Manual Part 30 (45 FR 76519, 19 November 1980)
- 21 CFR 25.15 - General procedures - all applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion; a claim of categorical exclusion must include a statement of compliance with the categorical exclusion criteria and that no extraordinary circumstances exist
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