[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.15]

[Page 241]
 
                        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. 25.15  General procedures.


    (a) All applications or petitions requesting agency action require 
the submission of an EA or a claim of categorical exclusion. A claim of 
categorical exclusion shall include a statement of compliance with the 
categorical exclusion criteria and shall state that to the applicant's 
knowledge, no extraordinary circumstances exist. Failure to submit an 
adequate EA for an application or petition requesting action by the 
agency of a type specified in Sec. 25.20, unless the agency can 
determine that the action qualifies for exclusion under Secs. 25.30, 
25.31, 25.32, 25.33, or 25.34, is sufficient grounds for FDA to refuse 
to file or approve the application or petition. An EA adequate for 
filing is one that addresses the relevant environmental issues. An EA 
adequate for approval is one that contains sufficient information to 
enable the agency to determine whether the proposed action may 
significantly affect the quality of the human environment.
    (b) The responsible agency officials will evaluate the information 
contained in the EA to determine whether it is accurate and objective, 
whether the proposed action may significantly affect the quality of the 
human environment, and whether an EIS will be prepared. If significant 
effects requiring the preparation of an EIS are identified, FDA will 
prepare an EIS for the action in accordance with the procedures in 
subparts D and E of this part. If significant effects requiring the 
preparation of an EIS are not identified, resulting in a decision not to 
prepare an EIS, the responsible agency official will prepare a FONSI in 
accordance with Sec. 25.41.
    (c) Classes of actions that individually or cumulatively do not 
significantly affect the quality of the human environment ordinarily are 
excluded from the requirement to prepare an EA or an EIS. The classes of 
actions that qualify as categorical exclusions are set forth in 
Secs. 25.30, 25.31, 25.32, 25.33, or 25.34.
    (d) A person submitting an application or petition of a type subject 
to categorical exclusion under Secs. 25.30, 25.31, 25.32, 25.33, or 
25.34, or proposing to dispose of an article as provided in 
Sec. 25.30(d) or 25.32(h), is not required to submit an EA if the person 
states that the action requested qualifies for a categorical exclusion, 
citing the particular categorical exclusion that is claimed, and states 
that to the applicant's knowledge, no extraordinary circumstances exist.