[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: 21CFR25.20]
[Page 237-238]
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 Sec. Sec. 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 Sec. Sec. 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 Sec. Sec.
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 Sec. Sec.
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).
[[Page 238]]
(h) Withdrawal of existing approvals of FDA-approved articles,
unless categorically excluded in Sec. Sec. 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 amendment of a
regulation for a prior-sanctioned food ingredient, as defined in
Sec. Sec. 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]
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