[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

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 chemical reaction, to obtain a manufacturing use 

product or an end use product, or



[[Page 92]]



    (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).