United States Prevention, Pesticides EPA 712-C-96-011
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Product Properties
Test Guidelines
OPPTS 830.1700
Preliminary Analysis
-------
INTRODUCTION
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
(OECD).
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 162.140.64.19), 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 830.1700 Preliminary analysis.
(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 158.170 Preliminary analysis.
(b) Information required. (1) If the product consists solely of the
technical grade active ingredient (TGAI) or is produced by an integrated
system, the applicant must provide a preliminary analysis of each technical
grade of active ingredient contained in the product to identify all impurities
present at 0.1 percent or greater of the TGAI (the Agency recognizes that
this may not be appropriate for certain biologicial pesticides). The prelimi-
nary analysis of 5 batches (if batch production) or 5 samples (if continuous
production) should be conducted at the point in the production process
after which no further chemical reactions designed to produce or purify
the substance are intended.
(2) Based on the preliminary analysis, a statement of the composition
of the technical grade of active ingredient must be provided. If the tech-
nical grade of active ingredient cannot be isolated, a statement of the com-
position of the practical equivalent of the technical grade of active ingredi-
ent must be submitted.
(c) Data reporting format. (1) The manufacturer's/registrant's/peti-
tioner's reports should include all information necessary to provide com-
plete and accurate topical discussions of the pesticide product.
(i) Title/cover page. Title page and additional documentation require-
ments (i.e., requirements for data submission and procedures for claims
of confidentiality of data) if relevant to the study report should precede
the content of the study formatted below. These requirements are described
in Pesticide Regulation Notice PR 86-5 (see paragraph (d)(l) of this guide-
line).
(ii) Table of contents.
(A) Summary and introduction.
(7) Scope and source of method (e.g., "Official Methods of Analysis
of AOAC-International," or "EPA Manual of Chemical Methods for Pes-
ticides and Devices" (see paragraphs (d)(l) and (d)(2) of this guideline).
(2) Principles of the analytical procedure (describe) including identi-
fication of the chemical species determined and the limits of detection
and sensitivity.
(B) Materials and methods.
-------
(7) Equipment (list and describe).
(2) Reagents and standards (list and describe source and preparation).
Analytical procedure (detail in a stepwise fashion, with special
emphasis on reagents or procedural steps requiring special precautions to
avoid safety or health hazards):
(/) Preparation of sample.
(//) Extraction (demonstrate efficiency, if relevant).
(///) Clean-up.
(/v) Derivatization (if any).
(4) Instrumentation (to include information on):
(/) Description (e.g., make/model, type/specificity of detectors, col-
umns, (packing materials, size), carrier gases, etc.).
(//) Operating conditions (e.g., flow rates, temperatures, voltage, etc.).
(Hi) Calibration procedures.
(5) Interferences (describe tests):
(/) Sample matrices.
(//) Other pesticides.
(Hi) Solvents.
(iv) Labware.
(6) Confirmatory techniques (describe).
(7) Time required for analysis (to carry a sample/set completely
through the analytical procedure, including the determinative step).
(8) Modifications or potential problems, if any, in analytical methods
(detail circumstances and corrective action to be taken).
(9) Methods of calculation (describe in a stepwise fashion):
(/) Calibration factors.
(//) Analyte in sample.
(10) Other (any and all relevant information the petitioner considers
appropriate and relevant to provide a complete and thorough description
of residue analytical methodology and the means of calculating the residue
results).
-------
(C) Results and discussion (describe expected performance of meth-
od).
(7) Accuracy (expected mean and range of recoveries).
(2) Precision.
(3) Limits of detection and quantification (provide definition).
(4) Ruggedness testing , if performed.
(5) Limitations.
(D) Conclusions. Discuss applicability of analytical procedure for
measuring specific test compounds in various test substrates, ready avail-
ability of equipment, interferences, etc.
(E) Certification. Certification of authenticity by the study director
(including signature, typed name, title, affiliation, address, telephone num-
ber, date).
(F) Tables and figures.
(G) References.
(H) Appendices.
(7) Representative chromatograms, spectra, etc. (as applicable).
(2) Other (any relevant material not fitting in any of the other sections
to this report).
(2) [Reserved]
(d) References. The following references should be consulted for ad-
ditional background material on this test guideline.
(1) Environmental Protection Agency, Pesticide Regulation Notice PR
86-5, Standard Format for Data Submitted Under the FIFRA and Certain
Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), July
29, 1986.
(2) Official Methods of Analysis of AOAC-International, Association
of Offical Analytical Chemists (AOAC)-International, Arlington, VA, lat-
est edition.
(3) EPA Manual of Chemical Methods for Pesticides and Devices,
published by Association of Official Analytical Chemists (AOAC), Arling-
ton, VA (1992).
------- |