[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.21]

[Page 244]
 
                        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.