[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: 21CFR25.20]

[Page 244-245]
 
                        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. 25.20  Actions requiring preparation of an environmental assessment.

    Any proposed action of a type specified in this section ordinarily 
requires at least the preparation of an EA, unless it is an action in a 
specific class that qualifies for exclusion under Secs. 25.30, 25.31, 
25.32, 25.33, or 25.34:
    (a) Major recommendations or reports made to Congress on proposals 
for legislation in instances where the agency has primary responsibility 
for the subject matter involved.
    (b) Destruction or other disposition of articles condemned after 
seizure or whose distribution or use has been enjoined, unless 
categorically excluded in Secs. 25.30(d) or 25.32(h).
    (c) Destruction or other disposition of articles following detention 
or recall at agency request, unless categorically excluded in 
Secs. 25.30(d) or 25.32(h).
    (d) Disposition of FDA laboratory waste materials, unless 
categorically excluded in Sec. 25.30(m).
    (e) Intramural and extramural research supported in whole or in part 
through contracts, other agreements, or grants, unless categorically 
excluded in Sec. 25.30 (e) or (f).
    (f) Establishment by regulation of labeling requirements, a 
standard, or a monograph, unless categorically excluded in 
Secs. 25.30(k) or 25.31 (a), (b), (c), (h), (i), or (j), or 25.32 (a) or 
(p).
    (g) Issuance, amendment, and enforcement of FDA regulations, or an 
exemption or variance from FDA regulations, unless categorically 
excluded in Sec. 25.30 (h), (i), or (j), or Sec. 25.32 (e), (g), (n), or 
(p).
    (h) Withdrawal of existing approvals of FDA-approved articles, 
unless categorically excluded in Secs. 25.31 (d) or (k), 25.32(m), or 
25.33 (g) or (h).
    (i) Approval of food additive petitions and color additive 
petitions, approval of requests for exemptions for investigational use 
of food additives, the granting of requests for exemption from 
regulation as a food additive under Sec. 170.39 of this chapter, and 
allowing notifications submitted under 21 U.S.C. 348(h) to become 
effective, unless categorically excluded in Sec. 25.32(b), (c), (i), 
(j), (k), (l), (o), (q), or (r).
    (j) Establishment of a tolerance for unavoidable poisonous or 
deleterious substances in food or in packaging materials to be used for 
food.
    (k) Affirmation of a food substance as GRAS for humans or animals, 
on FDA's initiative or in response to a petition, under parts 182, 184, 
186, or 582 of this chapter and establishment or

[[Page 245]]

amendment of a regulation for a prior-sanctioned food ingredient, as 
defined in Secs. 170.3(l) and 181.5(a) of this chapter, unless 
categorically excluded in Sec. 25.32 (f), (k), or (r).
    (l) Approval of NDA's, abbreviated applications, applications for 
marketing approval of a biologic product, supplements to such 
applications, and actions on IND's, unless categorically excluded in 
Sec. 25.31 (a), (b), (c), (e), or (l).
    (m) Approval of NADA's, abbreviated applications, supplements, and 
actions on INAD's, unless categorically excluded under Sec. 25.33 (a), 
(c), (d), or (e).
    (n) Approval of PMA's for medical devices, notices of completion of 
PDP's for medical devices, authorizations to commence clinical 
investigation under an approved PDP, or applications for an IDE, unless 
categorically excluded in Sec. 25.34.

[62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000]