United States Prevention, Pesticides EPA712-C-96-295
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.1400
Analysis of Samples
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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 guideline 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 also available electronically in ASCII and PDF (portable
document format) from the EPA Public Access Gopher (gopher.epa.gov)
under the heading "Environmental Test Methods and Guidelines."
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OPPTS 885.1400 Analysis of samples.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) (7 U.S.C. 136, et seq.}.
(2) Background. The source material used in developing this har-
monized OPPTS test guideline are OPP guidelines 151A-1 and 151A-
13.
(b) Information needed. The product analysis data requirements for
microbial pest control agents (MPCAs) parallel those for conventional
chemical pesticides in OPPTS Series 830. However, due to the unique
nature, composition, and mode of action of the MPCAs, there are some
important differences. For example, protozoa, bacteria, fungi, and viruses
should be identified to the extent possible by taxonomic position, serotype,
composition, and strain, or by any other appropriate specific means. This
information would take the place of chemical name and structure informa-
tion for conventional chemical pesticides. In addition, the Agency must
be reasonably assured that the methods used and the data submitted are
capable of demonstrating that the microbial pesticide used in the field is
the same as that which was tested for safety.
(c) Analytical results. A report on the results of preliminary analysis
are required by 40 CFR 158.740 to support the registration of each manu-
facturing-use product and those end-use products produced by an inte-
grated formulation system.
(d) Reporting of analytical results. The information in OPPTS
830.1800 regarding the analysis of samples shall apply (with the exception
that a quantitative serological or other appropriate test for the MPCA may
be substituted for the chemical analysis or may be used for confirmation).
(e) Requests for waiver of requirements. The Agency shall entertain
waiver requests for analysis down to 0.1 percent (w:w) based upon the
nature of the organism, the manufacturing process, and known or potential
ability of the MPCA to produce a toxin or other residue of concern to
the Agency.
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