United States       Prevention, Pesticides     EPA712-C-96-273
          Environmental Protection    and Toxic Substances     February 1996
          Agency         (7101)
&EPA   Microbial Pesticide
          Test Guidelines
          OPPTS885.1100
          Product Identity

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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 885.1100  Product identity.
     (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 OECD guidelines 151A-1 and  151A-
10.

     (b) Product identity. The product analysis data requirements for mi-
crobial pest control agents (MPCAs) parallel those for conventional chemi-
cal 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, composi-
tion, and strain, or by any other appropriate specific means. This informa-
tion  would take the place of chemical name  and structure information for
conventional chemical pesticides. In addition, the Agency must be reason-
ably 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. As required by 40 CFR 158.740, each
application for registration of an MPCA shall contain the following  infor-
mation: The product name;  the trade names  (if different).  The company
code numbers may be given.

     (c) Confidential statement of formula.  As  required by 40  CFR
158.740, an  application for registration of a product shall contain  a con-
fidential statement of formula (CSF). The appropriate  EPA  form  (EPA
Form 8570-4) shall be used. This statement shall include the nature and
quantity of the active ingredients and diluents and the identity  and purpose
of inert ingredients  such as  ultraviolet screens, stickers,  spreaders, and
other such material. The name of each ingredient in the product for which
OPPTS 830.1550 requires certified limits to be  established shall be listed.
A separate CSF is required for each alternate formula of a product. See
section  10 of the Act for requirements related to the protection of trade
secrets.

     (d) Information on ingredients. Information on ingredients  is re-
quired by 40 CFR  158.740 to  support  each application for  registration.

     (1) The identification of the MPCAs in the product shall (to the extent
possible) include the following:

     (i) The  taxonomic position,  serotype, strain, or any other appropriate
designation.  The precise test procedures and criteria used for identification
(i.e., the morphological, biochemical, analytical  (physical, chemical), sero-
logical, or other identification means) and the results of such  tests  should
be provided. If the MPCA contains plasmids or other extrachromosomal
genetic  elements involved in pesticidal  activity, pathogenicity,  toxicity,

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etc., these must be identified as well as any known phenotypic characters
coded  by such elements and  their stability. Whether or not a wild type
or genetically altered  strain is considered to be a new active ingredient
will be determined on  a case-by-case basis upon comparison with existing
related strains.

     (ii) The common,  alternative, and superseded names.

     (iii) The natural occurrence  of the organism, its relationship to other
species (particularly those that are pathogenic), and its history.

     (iv) A  description of the  morphological types  of the MPCA and any
unusual morphological, biochemical, or resistance characteristics of the or-
ganism if such characteristics  are different from the classic description of
the organism.

     (v) The amount of MPCA present in the product in recognized units
of potency,  percentage of weight, units of MPCA per unit weight or vol-
ume of product, or other appropriate expression of biological activity.

     (vi) The biological properties of the active agent with respect to target
species, pest host range, life cycle, and mode of action. With respect to
the properties of the microbial agent, any known or potential hazard (such
as infectivity) to mammals (including humans), the environment, and non-
target species should be discussed.

     (vii) If the MPCA in question has been altered genetically, in addition
to paragraph (d)(l)(i through vi) of this guideline, the methods used to
alter the microbe genetically should be provided. In the case of genetically
altered products, the identity  of the inserted or deleted genetic  material
(source, nature, size, base sequence  data and/or restriction  endonuclease
map),  information  on  the gene control  region,  descriptions  of  the
phenotypic  traits to be gained or lost,  and information as  to  the genetic
stability (reversion tendency or rate of exchange/transfer with other orga-
nisms) of the genetically altered chromosomal region or extrachromosomal
entity  are to be discussed.  Genetic material adjacent to  the intentionally
inserted genes which may have been engineered into the recipient are to
be fully characterized  and the likelihood of expression must be provided.

     (2) An  application for registration shall contain the following informa-
tion on each ingredient, other than the  MPCAs,  listed in the CSF rquired
in paragraph (c) of this guideline which is known to be present or which
might reasonably be identified in the pesticide product.

     (i) Percentage  composition (by weight) of each ingredient; the number
of units per  unit volume  or weight is needed for microbial impurities;  via-
bility data in terms of  PFU, CPU, etc., per unit weight or volume of prod-
uct.

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    (ii) Whether the ingredient is an active ingredient, an intentionally
added ingredient, or an impurity.

    (iii) The chemical name from the Chemical Abstracts Index of No-
menclature,  or other well-defined name.  (If one or more impurities are
microbial agents, the agents are to be classified/identified according to ac-
ceptable nomenclatural systems.)

    (iv) The Chemical Abstracts (CAS) Registry Number.

    (v) The product name, the trade name, and the common name.

    (vi) The experimental or internal code number.

    (vii) For each active ingredient  other than the MPCA, the empirical
formula, and the molecular weight or the molecular weight range.

    (viii) The structural formula (when known).

    (ix) The composition limits for each ingredient  for which OPPTS
830.1550 requires limits to be certified.  This information is to be  listed
on the CSF, EPA  Form 8570-4 revised  2/85 (or superseding revisions).

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