[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: 40CFR158.167]



[Page 94-95]

 

                   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.  158.167  Discussion of formation of impurities.



    The applicant must provide a discussion of the impurities that may 

be present in the product, and why they may be present. The discussion 

should be based on established chemical theory and on what the applicant 

knows about the starting materials, technical grade of active 

ingredient, inert ingredients, and production or formulation process. If 

the applicant has reason to believe that an impurity that EPA would 

consider toxicologically significant may be present, the discussion must 

include an expanded discussion of the possible formation of the impurity 

and the amounts at which it might be present. The impurities which must 

be



[[Page 95]]



discussed are the following, as applicable:

    (a) Technical grade active ingredients and products produced by an 

integrated system. (1) Each impurity associated with the active 

ingredient which was found to be present in any analysis of the product 

conducted by or for the applicant.

    (2) Each other impurity which the applicant has reason to believe 

may be present in his product at any time before use at a level equal to 

or greater than 0.1 percent (1000 ppm) by weight of the technical grade 

of the active ingredient, based on what he knows about the following:

    (i) The composition (or composition range) of each starting material 

used to produce his product.

    (ii) The impurities which he knows are present (or believes are 

likely to be present) in the starting materials, and the known or 

presumed level (or range of levels) of those impurities.

    (iii) The intended reactions and side reactions which may occur in 

the production of the product, and the relative amounts of byproduct 

impurities produced by such reactions.

    (iv) The possible degradation of the ingredients in the product 

after its production but prior to its use.

    (v) Post-production reactions between the ingredients in the 

product.

    (vi) The possible migration of components of packaging materials 

into the pesticide.

    (vii) The possible carryover of contaminants from use of production 

equipment previously used to produce other products or substances.

    (viii) The process control, purification and quality control 

measures used to produce the product.

    (b) Products not produced by an integrated system. Each impurity 

associated with the active ingredient which the applicant has reason to 

believe may be present in the product at any time before use at a level 

equal to or greater than 0.1 percent (1000 ppm) by weight of the product 

based on what he knows about the following:

    (1) The possible carryover of impurities present in any registered 

product which serves as the source of any of the product's active 

ingredients. The identity and level of impurities in the registered 

source need not be discussed or quantified unless known to the 

formulator.

    (2) The possible carryover of impurities present in the inert 

ingredients in the product.

    (3) Possible reactions occurring during the formulation of the 

product between any of its active ingredients, between the active 

ingredients and inert ingredients, or between the active ingredients and 

the production equipment.

    (4) Post-production reactions between any of the product's active 

ingredients and any other component of the product or its packaging.

    (5) Possible migration of packaging materials into the product.

    (6) Possible contaminants resulting from earlier use of equipment to 

produce other products.

    (c) Expanded discussion. On a case-by-case basis, the Agency may 

require an expanded discussion of information of impurities:

    (1) From other possible chemical reactions;

    (2) Involving other ingredients; or

    (3) At additional points in the production or formulation process.