[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.1]

[Page 263-264]
 
                        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. 25.1  Purpose.




                      Subpart A_General Provisions

Sec.
25.1 Purpose.
25.5 Terminology.
25.10 Policies and NEPA planning.

     Subpart B_Agency Actions Requiring Environmental Consideration

25.15 General procedures.
25.16 Public health and safety emergencies.
25.20 Actions requiring preparation of an environmental assessment.
25.21 Extraordinary circumstances.
25.22 Actions requiring the preparation of an environmental impact 
          statement.

                    Subpart C_Categorical Exclusions

25.30 General.
25.31 Human drugs and biologics.
25.32 Foods, food additives, and color additives.
25.33 Animal drugs.
25.34 Devices and electronic products.

[[Page 264]]

            Subpart D_Preparation of Environmental Documents

25.40 Environmental assessments.
25.41 Findings of no significant impact.
25.42 Environmental impact statements.
25.43 Records of decision.
25.44 Lead and cooperating agencies.
25.45 Responsible agency official.

    Subpart E_Public Participation and Notification of Environmental 
                                Documents

25.50 General information.
25.51 Environmental assessments and findings of no significant impact.
25.52 Environmental impact statements.

                      Subpart F_Other Requirements

25.60 Environmental effects abroad of major agency actions.

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 
4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 
Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 
Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-
360.

    Source: 62 FR 40592, July 29, 1997, unless otherwise noted.



    The National Environmental Policy Act of 1969 (NEPA), as amended, 
directs that, to the fullest extent possible, the policies, regulations, 
and public laws of the United States shall be interpreted and 
administered in accordance with the policies set forth in NEPA. All 
agencies of the Federal Government shall comply with the procedures in 
section 102(2) of NEPA except where compliance would be inconsistent 
with other statutory requirements. The regulations in this part 
implement section 102(2) of NEPA in a manner that is consistent with 
FDA's authority under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act. This part also supplements the regulations 
for implementing the procedural provisions of NEPA that were published 
by the Council on Environmental Quality (CEQ) in 40 CFR parts 1500 
through 1508 and the procedures included in the ``HHS General 
Administration Manual, part 30: Environmental Protection'' (45 FR 76519 
to 76534, November 19, 1980).