# 21 CFR § 25.21: Extraordinary circumstances

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-25.21

## Section

- **Citation:** 21 CFR § 25.21
- **Heading:** Extraordinary circumstances
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL > PART 25—ENVIRONMENTAL IMPACT CONSIDERATIONS > Subpart B—Agency Actions Requiring Environmental Consideration

## Text

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.

## Nearby sections

- [21 CFR § 25.1 § 25.1 Purpose.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.1.md)
- [21 CFR § 25.5 § 25.5 Terminology.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.5.md)
- [21 CFR § 25.10 § 25.10 Policies and NEPA planning.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.10.md)
- [21 CFR § 25.15 § 25.15 General procedures.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.15.md)
- [21 CFR § 25.16 § 25.16 Public health and safety emergencies.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.16.md)
- [21 CFR § 25.20 § 25.20 Actions requiring preparation of an environmental assessment.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.20.md)
- [21 CFR § 25.21 § 25.21 Extraordinary circumstances.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.21.md)
- [21 CFR § 25.22 § 25.22 Actions requiring the preparation of an environmental impact statement.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.22.md)
- [21 CFR § 25.30 § 25.30 General.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.30.md)
- [21 CFR § 25.31 § 25.31 Human drugs and biologics.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.31.md)
- [21 CFR § 25.32 § 25.32 Foods, food additives, and color additives.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.32.md)
- [21 CFR § 25.33 § 25.33 Animal drugs.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.33.md)
- [21 CFR § 25.34 § 25.34 Devices and electronic products.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.34.md)
- [21 CFR § 25.35 § 25.35 Tobacco product applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-25.35.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-25.21. Check the current official text before relying on it. Not legal advice.