[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: 21CFR25.32]
[Page 240-241]
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 C Categorical Exclusions
Sec. 25.32 Foods, food additives, and color additives.
The classes of actions listed in this section are categorically
excluded and, therefore, ordinarily do not require the preparation of an
EA or an EIS:
(a) Issuance, amendment, or repeal of a food standard.
(b) Action on a request for exemption for investigational use of a
food additive if the food additive to be shipped under the request is
intended to be used for clinical studies or research.
(c) Approval of a color additive petition to change a provisionally
listed color additive to permanent listing for use in food, drugs,
devices, or cosmetics.
(d) Testing and certification of batches of a color additive.
(e) Issuance of an interim food additive regulation.
(f) 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, if the substance or
food ingredient is already marketed in the United States for the
proposed use.
(g) Issuance and enforcement of regulations relating to the control
of communicable diseases or to interstate conveyance sanitation under
parts 1240 and 1250 of this chapter.
(h) Approval of a request for diversion of adulterated or misbranded
food for humans or animals to use as animal feeds.
(i) Approval of a food additive petition or GRAS affirmation
petition, the granting of a request for exemption from regulation as a
food additive under Sec. 170.39 of this chapter, or allowing a
notification submitted under 21 U.S.C. 348(h) to become effective, when
the substance is present in finished food-packaging material at not
greater than 5 percent-by-weight and is expected to remain with finished
food-packaging material through use by consumers or when the substance
is a component of a coating of a finished food-packaging material.
(j) Approval of a food additive petition or GRAS affirmation
petition, the granting of a request for exemption from regulation as a
food additive under Sec. 170.39 of this chapter, or allowing a
notification submitted under 21 U.S.C. 348(h) to become effective, when
the substance is to be used as a component of a food-contact surface of
permanent or semipermanent equipment or of another food-contact article
intended for repeated use.
(k) Approval of a food additive petition, color additive petition,
or GRAS affirmation petition, or allowing a notification submitted under
21 U.S.C. 348(h) to become effective, for substances added directly to
food that are intended to remain in food through ingestion by consumers
and that are not intended to replace macronutrients in food.
(l) Approval of a petition for color additives used in contact
lenses, sutures, filaments used as supporting haptics in intraocular
lenses, bone cement, and in other FDA-regulated products having
similarly low levels of use.
(m) Action to prohibit or otherwise restrict or reduce the use of a
substance in food, food packaging, or cosmetics.
(n) Issuance, amendment, or revocation of a regulation pertaining to
infant formulas.
(o) Approval of a food additive petition for the intended expression
product(s) present in food derived from new plant varieties.
[[Page 241]]
(p) Issuance, amendment, or revocation of a regulation in response
to a reference amount petition as described in Sec. 101.12(h) of this
chapter, a nutrient content claim petition as described in Sec. 101.69
of this chapter, a health claim petition as described in Sec. 101.70 of
this chapter, or a petition pertaining to the label declaration of
ingredients as described in Sec. 101.103 of this chapter.
(q) Approval of a food additive petition, the granting of a request
for exemption from regulation as a food additive under Sec. 170.39 of
this chapter, or allowing a notification submitted under 21 U.S.C.
348(h) to become effective for a substance registered by the
Environmental Protection Agency under FIFRA for the same use requested
in the petition, request for exemption, or notification.
(r) Approval of a food additive petition, color additive, GRAS
affirmation petition, or allowing a notification submitted under 21
U.S.C. 348(h) to become effective for a substance that occurs naturally
in the environment, when the action does not alter significantly the
concentration or distribution of the substance, its metabolites, or
degradation products in the environment.
[62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000]
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