United States Prevention, Pesticides EPA712-C-96-293
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.1200
Manufacturing Process
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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. 1200 Manufacturing process.
(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-
11.
(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. Each application for registra-
tion of a manufacturing-use product or end-use product shall contain a
description of the basic manufacturing process. The starting and intermedi-
ate materials should be listed (including EPA Registration No. and/or
source and purity) together with the steps taken to ensure the integrity
of these materials, and the steps taken to limit the extraneous contamina-
tion, both chemical and biological, in preparations of the unformulated
MPCA. This description shall include the procedures used by the manufac-
turer to establish the identity and purity of the culture from which the
unformulated MPCA is produced, the method of manufacture, and tech-
niques used to ensure a uniform or standardized product. The integrity
of the product as determined by specific and sensitive chemical, serologi-
cal or biological tests is to be demonstrated. If the test is not a recognized
standard test, a detailed description of the test together with information
regarding precision, specificity, interfering substances, accuracy, and sen-
sitivity must be provided.
(c) Maintenance of samples. A sample of registered MPCAs is to
be maintained on deposit in a nationally recognized culture collection. A
large initial batch could be preserved in small aliquots to serve as seed
stock for subsequent batches. This would minimize contamination and var-
iation (chromosomal and extrachromosomal) caused by serial passage. If
the MPCA produces a toxin, this may need to be monitored as a form
of quality control.
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