United States       Prevention, Pesticides     EPA 712-96-012
          Environmental Protection    and Toxic Substances     August 1996
          Agency        (7101)
&EPA   Product Properties
          Test Guidelines
          OPPTS 830.1750
          Certified Limits

     This guideline is one  of a series  of test guidelines  that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental Protection Agency for use in the testing  of
pesticides and toxic substances, and the  development of test data that must
be submitted to the Agency  for review under Federal regulations.

     The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has  developed this guideline through  a  process of harmonization that
blended the testing  guidance and requirements that existed in the Office
of Pollution Prevention and Toxics  (OPPT) and appeared in Title 40,
Chapter I,  Subchapter R of the Code of Federal Regulations  (CFR), the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical  Information Service (NTIS) and  the guidelines pub-
lished by the Organization  for Economic Cooperation and Development

     The purpose of harmonizing these guidelines into a single set  of
OPPTS  guidelines is to minimize variations among the testing procedures
that must be performed to meet the data  requirements of the U. S. Environ-
mental Protection Agency  under the Toxic  Substances Control Act (15
U.S.C. 2601) and the Federal Insecticide,  Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).

     Final  Guideline Release: This document is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin  Board.   By  modem  dial   202-512-1387,   telnet   and  ftp:
fedbbs.access.gpo.gov     (IP,    internet:     http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies.
This guideline is available in ASCII and PDF (portable document format)
from the EPA Public Access Gopher (gopher.epa.gov) under the heading
"Environmental Test Methods and Guidelines."

OPPTS 830.1750   Certified limits.
     (a) Scope—(1) Applicability. This guideline is intended to meet test-
ing  requirements   of both the  Federal  Insecticide,  Fungicide,  and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.) and the Toxic Substances
Control Act (TSCA) (15 U.S.C. 2601).

     (2) Background. The  source material used in developing this har-
monized OPPTS test guideline is 40 CFR 158.175 Certified limits.

     (b) Information  required. The applicant must propose certified lim-
its for the ingredients  in the product. Certified limits become legally bind-
ing 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.

     (c) 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 consists solely of the technical grade of active ingre-
dient or is produced by an integrated system, an upper limit for each impu-
rity 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.

     (d) Determination of standard certified limits for active and inert
ingredients. Unless the applicant proposes different limits as provided in
paragraph (e) of this  guideline, the upper and  lower certified  limits for
active and inert ingredients will be determined on the basis of the nominal
concentration of the ingredient in the product, according to  the  following
table 1:

                 Table 1.—Standard Certified Limits
If the nominal con-
centration (N) for
the ingredient is:
N< 1 0%
     (e) Applicant proposed limits. (1) The applicant may propose a cer-
tified limit for an active or inert ingredient that differs from the standard
certified limit calculated according to paragraph (d) of this guideline.

     (2) If certified limits are required for impurities, the applicant must
propose upper certified limits. 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 or

     (4) The applicant must include an explanation of the basis of his pro-
posed 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.

     (f) Special cases. If the Agency finds unacceptable any certified limit
(either standard or applicant-proposed), the Agency will inform the appli-
cant of its determination and will provide supporting reasons. The Agency
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 deter-

     (3) A narrower range between the  upper and  lower certified limits
than that proposed.

     (g) 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 rep-
resentative of the company, is acceptable.

    I hereby certify that for purposes of FIFRA section 12(a)(l)(C), the descrip-
tion 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: No ingre-
dient 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 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.
     (h) References. The following references should be consulted for ad-
ditional background material on this test guideline.

     (1) Official Methods of Analysis of AOAC-International, Association
of Offical Analytical Chemists (AOAC)-International, Arlington, VA, lat-
est edition.

     (2) EPA Manual of Chemical Methods for Pesticides  and Devices,
published by Association of Official Analytical Chemists (AOAC), Arling-
ton, VA (1992).