[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: 21CFR25.10]
[Page 236]
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 A General Provisions
Sec. 25.10 Policies and NEPA planning.
(a) All FDA's policies and programs will be planned, developed, and
implemented to achieve the policies declared by NEPA and required by
CEQ's regulations to ensure responsible stewardship of the environment
for present and future generations.
(b) Assessment of environmental factors continues throughout
planning and is integrated with other program planning at the earliest
possible time to ensure that planning and decisions reflect
environmental values, to avoid delays later in the process, and to avoid
potential conflicts.
(c) For actions initiated by the agency, the NEPA process will begin
when the agency action under consideration is first identified. For
actions initiated by applicants or petitioners, NEPA planning begins
when FDA receives from an applicant or petitioner an EA or a claim that
a categorical exclusion applies, or when FDA personnel consult with
applicants or petitioners on the NEPA-related aspects of their requested
actions. FDA may issue a public call for environmental data or otherwise
consult with affected individuals or groups when a contemplated action
in which it is or may be involved poses potential significant
environmental effects.
(d) Environmental documents shall concentrate on timely and
significant issues, not amass needless detail.
(e) If a proposed action for which an EIS will be prepared involves
possible environmental effects that are required to be considered under
statutes or Executive Orders other than those referred to under
``Authority'' in this part, these effects shall be considered in the
NEPA review, consistent with 40 CFR 1502.25 and the HHS General
Administration Manual, part 30: Environmental Protection.
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