[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.15]
 
[Page 243-244]
 
                        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. 25.15  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
 
[[Page 244]]
 
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.