---identifier: "/us/cfr/t21/s25.43"source: "ecfr"legal_status: "authoritative_unofficial"title: "21 CFR § 25.43 - Records of decision."title_number: 21title_name: "Food and Drugs"section_number: "25.43"section_name: "Records of decision."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/s25.43
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.
# 25.43 Records of decision.(a) In cases requiring environmental impact statements, at the time of its decision, the agency shall prepare a concise public record of decision.(b) The record of decision shall:(1) State what the decision was;(2) Identify and discuss alternatives considered by the agency in reaching its decision;(3) State whether all practicable means to avoid or minimize environmental harm have been adopted, and if not, why not; and(4) Summarize the program for monitoring and enforcing the practicable means adopted to avoid or minimize the environmental harm.