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) 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 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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