[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: 40CFR158.175]



[Page 95-97]

 

                   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.  158.175  Certified limits.



    The applicant must propose certified limits for the ingredients in 

the product. Certified limits become legally



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binding limits upon approval of the application. Certified limits will 

apply to the product from the date of production to date of use, unless 

the product label bears a statement prohibiting use after a certain 

date, in which case the certified limits will apply only until that 

date.

    (a) Ingredients for which certified limits are required. Certified 

limits are required on the following ingredients of a pesticide product:

    (1) An upper and lower limit for each active ingredient.

    (2) An upper and lower limit for each inert ingredient.

    (3) If the product is a technical grade of active ingredient or is 

produced by an integrated system, an upper limit for each impurity of 

toxicological significance associated with the active ingredient and 

found to be present in any sample of the product.

    (4) On a case-by-case basis, certified limits for other ingredients 

or impurities as specified by EPA.

    (b) EPA determination of certified limits for active and inert 

ingredients. (1) Unless the applicant proposes different limits as 

provided in paragraph (c) of this section, the upper and lower certified 

limits for active and inert ingredients will be determined by EPA. EPA 

will calculate the certified limits on the basis of the nominal 

concentration of the ingredient in the product, according to the table 

in paragraph (b)(2) of this section.

    (2) Table of standard certified limits.



------------------------------------------------------------------------

                                      The certified limits for that

  If the nominal concentration        ingredient will be as follows:

   (N) for the ingredient is:   ----------------------------------------

                                     Upper limit          Lower limit

------------------------------------------------------------------------

N <= 1.0%......................  N + 10%N             N - 10%N

1.0% < N <= 20.0%..............  N + 5%N              N - 5%N

20.0% < N <= 100.0%............  N + 3%N              N - 3%N

------------------------------------------------------------------------



    (c) Applicant proposed limits. (1) The applicant may propose a 

certified limit for an active or inert ingredient that differs from the 

standard certified limit calculated according to paragraph (b)(2) of 

this section.

    (2) If certified limits are required for impurities, the applicant 

must propose a certified limit. The standard certified limits may not be 

used for such substances.

    (3) Certified limits should:

    (i) Be based on a consideration of the variability of the 

concentration of the ingredient in the product when good manufacturing 

practices and normal quality control procedures are used.

    (ii) Allow for all sources of variability likely to be encountered 

in the production process.

    (iii) Take into account the stability of the ingredient in the 

product and the possible formation of impurities between production and 

sale of distribution.

    (4) The applicant may include an explanation of the basis of his 

proposed certified limits, including how the certified limits were 

arrived at (e.g., sample analysis, quantitative estimate based on 

production process), and its accuracy and precision. This will be 

particularly useful if the range of the certified limit for an active or 

inert ingredient is greater than the standard certified limits.

    (d) Special cases. If the Agency finds unacceptable any certified 

limit (either standard or applicant-proposed), the Agency will inform 

the applicant of its determination and will provide supporting reasons. 

EPA may also recommend alternative limits to the applicant. The Agency 

may require, on a case-by-case basis, any or all of the following:

    (1) More precise limits.

    (2) More thorough explanation of how the certified limits were 

determined.

    (3) A narrower range between the upper and lower certified limits 

than that proposed.

    (e) Certification statement. The applicant must certify the accuracy 

of the information presented, and that the certified limits of the 

ingredients will be maintained. The following statement, signed by the 

authorized representative of the company, is acceptable:



    I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the 

description of the composition of [product name], EPA Reg. No. [insert 

registration number], refers to the composition set forth on the 

Statement of Formula and supporting materials. This description includes 

the representations that: (1) no ingredient will be present in the 

product in an amount greater than the upper certified limit or in an 

amount less than the lower certified limit (if required) specified for 

that



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ingredient in a currently approved Statement of Formula (or as 

calculated by the Agency); and (2) if the Agency requires that the 

source of supply of an ingredient be specified, that all quantities of 

such ingredient will be obtained from the source specified in the 

Statement of Formula.