[Code of Federal Regulations]
[Title 40, Volume 20]
[Revised as of July 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR177.3]

[Page 278]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 177--ISSUANCE OF FOOD ADDITIVE REGULATIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 177.3  Definitions.

    For the purposes of this part:
    Administrator means the Administrator of the Agency, or an officer 
or employee of the Agency to whom the Administrator has delegated the 
authority to perform functions under this part.
    Agency means the United States Environmental Protection Agency.
    FFDCA means the Federal Food, Drug, and Cosmetic Act, as amended, 21 
U.S.C. 301-392.
    FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, 
7 U.S.C. 136-136y.
    Food additive means any substance the intended use of which results 
or may reasonably be expected to result, directly or indirectly, in its 
becoming a component of or otherwise affecting the characteristics of 
any food (including any such substance intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food), except that such term does not include:
    (1) A pesticide chemical in or on a raw agricultural commodity.
    (2) A pesticide chemical to the extent that it is intended for use 
or is used in the production, storage, or transportation of any raw 
agricultural commodity.
    (3) A color additive.
    (4) Any substance used in accordance with a sanction or approval 
granted prior to September 6, 1958, pursuant to the FFDCA, the Poultry 
Products Inspection Act, or the Federal Meat Inspection Act.
    (5) A new animal drug.
    (6) A substance that is generally recognized, among experts 
qualified by scientific training and experience to evaluate its safety, 
as having been adequately shown through scientific procedures (or, in 
the case of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use in food) 
to be safe under the conditions of its intended use.
    Food additive regulation means a regulation issued pursuant to FFDCA 
section 409 that states the conditions under which a food additive may 
be safely used. A food additive regulation under this part ordinarily 
establishes a tolerance for pesticide residues in or on a particular 
processed food or a group of such foods. It may also specify:
    (1) The particular food or classes of food in or on which a food 
additive may be used.
    (2) The maximum quantity of the food additive which may be used in 
or on such food.
    (3 The manner in which the food additive may be added to or used in 
or on such food.
    (4) Directions or other labeling or packaging requirements for the 
food additive.
    Pesticide chemical means any substance which alone, or in chemical 
combination with or in formulation with one or more other substances, is 
a ``pesticide'' within the meaning of FIFRA and which is used in the 
production, storage, or transportation of any raw agricultural commodity 
or processed food. The term includes any substance that is an active 
ingredient, intentionally-added inert ingredient, or impurity of such a 
``pesticide.''
    Pesticide residue means a residue of a pesticide chemical or of any 
metabolite or degradation product of a pesticide chemical.
    Tolerance means:
    (1) The amount of a pesticide residue that legally may be present in 
or on a raw agricultural commodity under the terms of a tolerance under 
FFDCA section 408 or a processed food under the terms of a food additive 
regulation under FFDCA section 409. Tolerances are usually expressed in 
terms of parts of the pesticide residue per million parts of the food 
(ppm), by weight.
    (2) [Reserved]

Subparts B-D [Reserved]

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