[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: 40CFR158.155]



[Page 92-93]

 

                   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.  158.155  Product composition.



    Information on the composition of the pesticide product must be 

furnished. The information required by paragraphs (a), (b) and (f) of 

this section must be provided for each product. In addition, if the 

product is produced by an integrated system, the information on 

impurities required by paragraphs (c) and (d) must be provided.

    (a) Active ingredient. The following information is required for 

each active ingredient in the product:

    (1) If the source of any active ingredient in the product is an EPA-

registered product:

    (i) The chemical and common name (if any) of the active ingredient, 

as listed on the source product.

    (ii) The nominal concentration of the active ingredient in the 

product, based upon the nominal concentration of active ingredient in 

the source product.

    (iii) Upper and lower certified limits of the active ingredient in 

the product, in accordance with Sec.  158.175.

    (2) If the source of any active ingredient in the product is not an 

EPA-registered product:

    (i) The chemical name according to Chemical Abstracts Society 

nomenclature, the CAS Registry Number, and any common names.

    (ii) The molecular, structural, and empirical formulae, and the 

molecular weight or weight range.

    (iii) The nominal concentration.

    (iv) Upper and lower certified limits in accordance with Sec.  

158.175.

    (v) The purpose of the ingredient in the formulation.

    (b) Inert ingredients. The following information is required for 

each inert ingredient (if any) in the product:

    (1) The chemical name of the ingredient according to Chemical 

Abstracts Society nomenclature, the CAS Registry Number, and any common 

names (if known). If the chemical identity or chemical composition of an 

ingredient is not known to the applicant because



[[Page 93]]



it is proprietary or trade secret information, the applicant must ensure 

that the supplier or producer of the ingredient submits to the Agency 

(or has on file with the Agency) information on the identity or chemical 

composition of the ingredient. Generally, it is not required that an 

applicant know the identity of each ingredient in a mixture that he uses 

in his product. However, in certain circumstances, the Agency may 

require that the applicant know the identity of a specific ingredient in 

such a mixture. If the Agency requires specific knowledge of an 

ingredient, it will notify the applicant in writing.

    (2) The nominal concentration in the product.

    (3) Upper and lower certified limits in accordance with Sec.  

158.175.

    (4) The purpose of the ingredient in the formulation.

    (c) Impurities of toxicological significance associated with the 

active ingredient. For each impurity associated with the active 

ingredient that is determined to be toxicologically significant, the 

following information is required:

    (1) Identification of the ingredient as an impurity.

    (2) The chemical name of the impurity.

    (3) The nominal concentration of the impurity in the product.

    (4) A certified upper limit, in accordance with Sec.  158.175.

    (d) Other impurities associated with the active ingredient. For each 

other impurity associated with an active ingredient that was found to be 

present in any sample at a level equal to or greater than 0.1 percent by 

weight of the technical grade active ingredient, the following 

information is required:

    (1) Identification of the ingredient as an impurity.

    (2) Chemical name of the impurity.

    (3) The nominal concentration of the impurity in the final product.

    (e) Impurities associated with an inert ingredient. [Reserved]

    (f) Ingredients that cannot be characterized. If the identity of any 

ingredient or impurity cannot be specified as a discrete chemical 

substance (such as mixtures that cannot be characterized or isomer 

mixtures), the applicant must provide sufficient information to enable 

EPA to identify its source and qualitative composition.