---identifier: "/us/cfr/t21/s25.45"source: "ecfr"legal_status: "authoritative_unofficial"title: "21 CFR § 25.45 - Responsible agency official."title_number: 21title_name: "Food and Drugs"section_number: "25.45"section_name: "Responsible agency official."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/s25.45
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.
# 25.45 Responsible agency official.(a) The responsible agency official prepares the environmental documents or ensures that they are prepared.(b) The responsible agency official will weigh any environmental impacts of each alternative course of action, including possible mitigation measures, and will balance environmental impacts with the agency's objectives in choosing an appropriate course of action. The weighing of any environmental impacts of alternatives in selecting a final course of action will be reflected in the agency's record of formal decisionmaking as required by 40 CFR 1505.2.[62 FR 40592, July 29, 1997, as amended at 69 FR 17291, Apr. 2, 2004]