21 CFR § 25.22 - Actions requiring the preparation of an environmental impact statement.
---identifier: "/us/cfr/t21/s25.22"source: "ecfr"legal_status: "authoritative_unofficial"title: "21 CFR § 25.22 - Actions requiring the preparation of an environmental impact statement."title_number: 21title_name: "Food and Drugs"section_number: "25.22"section_name: "Actions requiring the preparation of an environmental impact statement."chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"subchapter_number: "A"subchapter_name: "GENERAL"part_number: "25"part_name: "ENVIRONMENTAL IMPACT CONSIDERATIONS"positive_law: falsecurrency: "2026-04-05"last_updated: "2026-04-05"format_version: "1.1.0"generator: "[email protected]"authority: "21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360."regulatory_source: "62 FR 40592, July 29, 1997, unless otherwise noted."cfr_part: "25"---
Identifier
/us/cfr/t21/s25.22
Currency
2026-04-05
Positive Law
No
Updated
2026-04-05
Chapter
Food and Drug Administration, Department of Health and Human Services
Authority
21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp.... 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.
# 25.22 Actions requiring the preparation of an environmental impact statement.(a) There are no categories of agency actions that routinely significantly affect the quality of the human environment and that therefore ordinarily require the preparation of an EIS.(b) EIS's are prepared for agency actions when evaluation of data or information in an EA or otherwise available to the agency leads to a finding by the responsible agency official that a proposed action may significantly affect the quality of the human environment.