[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR158.153]

[Page 91-92]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 158--DATA REQUIREMENTS FOR REGISTRATION--Table of Contents
 
             Subpart C--Product Chemistry Data Requirements
 
Sec. 158.153  Definitions.

    The following terms are defined for the purposes of this subpart:
    (a) Active ingredient means any substance (or group of structurally 
similar substances, if specified by the Agency) that will prevent, 
destroy, repel or mitigate any pest, or that functions as a plant 
regulator, desiccant, or defoliant within the meaning of FIFRA sec. 
2(a).
    (b) End use product means a pesticide product whose labeling
    (1) Includes directions for use of the product (as distributed or 
sold, or after combination by the user with other substances) for 
controlling pests or defoliating, desiccating or regulating growth of 
plants, and
    (2) Does not state that the product may be used to manufacture or 
formulate other pesticide products.
    (c) Formulation means
    (1) The process of mixing, blending, or dilution of one or more 
active ingredients with one or more other active or inert ingredients, 
without an intended

[[Page 92]]

chemical reaction, to obtain a manufacturing use product or an end use 
product, or
    (2) The repackaging of any registered product.
    (d) Impurity means any substance (or group of structurally similar 
substances if specified by the Agency) in a pesticide product other than 
an active ingredient or an inert ingredient, including unreacted 
starting materials, side reaction products, contaminants, and 
degradation products.
    (e) Impurity associated with an active ingredient means:
    (1) Any impurity present in the technical grade of active 
ingredient; and
    (2) Any impurity which forms in the pesticide product through 
reactions between the active ingredient and any other component of the 
product or packaging of the product.
    (f) Inert ingredient means any substance (or group of structurally 
similar substances if designated by the Agency), other than an active 
ingredient, which is intentionally included in a pesticide product.
    (g) Integrated system means a process for producing a pesticide 
product that:
    (1) Contains any active ingredient derived from a source that is not 
an EPA-registered product; or
    (2) Contains any active ingredient that was produced or acquired in 
a manner that does not permit its inspection by the Agency under FIFRA 
sec. 9(a) prior to its use in the process.
    (h) Manufacturing use product means any pesticide product other than 
an end use product. A product may consist of the technical grade of 
active ingredient only, or may contain inert ingredients, such as 
stabilizers or solvents.
    (i) Nominal concentration means the amount of an ingredient which is 
expected to be present in a typical sample of a pesticide product at the 
time the product is produced, expressed as a percentage by weight.
    (j) Starting material means a substance used to synthesize or purify 
a technical grade of active ingredient (or the practical equivalent of 
the technical grade ingredient if the technical grade cannot be 
isolated) by chemical reaction.
    (k) Technical grade of active ingredient means a material containing 
an active ingredient:
    (1) Which contains no inert ingredient, other than one used for 
purification of the active ingredient; and
    (2) Which is produced on a commercial or pilot-plant production 
scale (whether or not it is ever held for sale).