[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.10]

[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 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

[[Page 237]]

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.