[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: 21CFR25.15]
[Page 236-237]
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
[[Page 237]]
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 Sec. Sec.
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
Sec. Sec. 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 Sec. Sec. 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.
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