[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR158.155]

[Page 100-101]
 
                   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

[[Page 101]]

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 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.