---identifier: "/us/cfr/t21/s25.21"source: "ecfr"legal_status: "authoritative_unofficial"title: "21 CFR § 25.21 - Extraordinary circumstances."title_number: 21title_name: "Food and Drugs"section_number: "25.21"section_name: "Extraordinary circumstances."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/s25.21
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.
# 25.21 Extraordinary circumstances.As required under 40 CFR 1508.4, FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of significant impacts). Examples of such extraordinary circumstances include:(a) Actions for which available data establish that, at the expected level of exposure, there is the potential for serious harm to the environment; and(b) Actions that adversely affect a species or the critical habitat of a species determined under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Flora and Fauna to be endangered or threatened or wild flora or fauna that are entitled to special protection under some other Federal law.