United States Prevention, Pesticides EPA712-C-96-296
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbialst Pesticide
Test Guidelines
OPPTS 885.1500
Certification of Limits
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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 885.1500 Certification of limits.
(a) Scope— (1) Applicability. This guideline is intended to meet test-
ing requirments of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 163, et seq.\
(2) Background. The source material used in developing this har-
monized OPPTS test guideline are OPP guidelines 151A-1 and 151A-
15.
(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) Certification of ingredient limits. (1) As required by 40 CFR
158.740, each registration must be supported by a certification of ingredi-
ent limits. Refer to OPPTS 830.1750 and 830.1800 regarding certification
of limits and analytical methods to verify certified limits. The limits for
MPCAs and contaminants should be expressed as:
(i) MPCA units per unit weight or volume which may determined
using biological, genetic, biochemical, serological or other appropriate
tests.
(ii) International units of potency per unit weight which may deter-
mined using biological, genetic, biochemical, serological or other appro-
priate tests.
(iii) Weight percent of product.
(2) Note that two or more methods may be required to verify the
certified limits of the MPCAs and any microbial impurities. Plate counts
(colony- or plaque-forming units per unit weight or volume) or infectivity
assays may be necessary for quantitation and to allow preliminary identi-
fication. Antibiotic resistance bioassays may eliminate some contamination
as well as provide additional identification support. In some cases, espe-
cially in the case of genetically altered MPCAs, absolute identification
can be achieved only through the use of one or more of the various
immunological methods (such as enzyme-linked immunosorbent assay) or
molecular probe methods (such as the Southern hybridization procedure
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or restriction endonuclease mapping). Methods must be specific enough
to determine the MPCA in the presence of revertants/mutants and contami-
nants that may have formed or been introduced during the replication/man-
ufacturing process.
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