[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: 40CFR158.175]

[Page 104-105]
 
                   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 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

[[Page 105]]

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 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.