[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.21]
[Page 238]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 25 ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents
Subpart B Agency Actions Requiring Environmental Consideration
Sec. 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.
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