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) Scopeó(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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