United States Prevention, Pesticides EPA712-C-96-294
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.1300
Discussion of Formation
of Unintentional
ngredients
-------
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."
-------
OPPTS 0885.1300 Discussion of formation of unintentional ingredi-
ents.
(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-
12.
(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) Registration applications. Each registration application shall in-
clude the following information:
(1) Theoretical discussion. The theoretical discussion concerns the
formation of each substance, aside from the control agents and inten-
tionally added, chemically characterized active and inert ingredients, that
might reasonably be present in the pesticide product, as outlined OPPTS
830.1670. Examples of such extraneous materials are: Allergens, microbial
toxins, and other metabolic products; mutant strains; microbial contami-
nants with particular reference to potentially infective or antagonistic
forms; side products from chemical reactions employed in the manufactur-
ing process, fermentation residues from the growth of bacteria or fungi;
extraneous host residues from viruses produced in cell cultures, whole ani-
mals, or other living forms; residues of contaminants that remain following
the purification or extraction process; and impurities in chemicals used
in the manufacturing process. The discussion shall include the procedures
used to ensure the purity of the unformulated MPCA preparation; if purity
(within reasonable limits) cannot be achieved, then the means of control-
ling contaminant levels to an acceptable limit must be delineated.
(2) Toxic or sensitizing substances. If substances toxic or sensitizing
to humans or other nontarget mammalian species are known or suspected
to be present at any stage of the manufacturing process, then data must
be submitted to show that the substances do not exist in the final product
or exist only in quantities too small to pose any hazard.
-------
(3) Human or animal pathogens. Human or other nontarget animal
pathogens such as (but not limited to) Shigella, Salmonella, and Vibrio
must not be present at hazardous levels in the technical grade of the active
ingredient. If the production method can support the growth of human or
animal pathogens, each production batch must be tested for their presence.
Each application for registration of a manufacturing-use product or end-
use product should contain an analysis of all human or animal pathogens
that might be present at potentially hazardous levels in the product before
formulation. The application should propose methodology for detecting
and/or eliminating these from the product. For example, the method pre-
scribed in 40 CFR 180.1011 to monitor each production batch of Bacillus
thuringiensis for the pathogen Bacillus anthracis involves subcutaneous
injection of at least 1 million viable microorganisms or spores into each
of 5 laboratory mice weighing 17 to 23 g. Such tests shall show no evi-
dence of infection or injury in the test animals when observed for 7 days
following injection.
(4) Detection of hazardous contamination. Methods should be pro-
posed for controlling any hazardous contamination detected in the product.
Discarding of a contaminated production batch or treating the formulation
may be equally acceptable methods for controlling the contaminating
microorganisms.
------- |