United States Prevention, Pesticides EPA712-C-96-307
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.2500
Magnitude of Residues
in Plants
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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 885.2500 Magnitude of residues in plants.
(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 is OPP guideline 153A-10.
(b) Microbial pest control agent residues of toxicological concern.
Microbial pest control agent (MPCA) residues of toxicological concern
must be determined in or on raw agricultural commodities (RACs) of all
crops on which use is proposed or, if preferred, RACs of each representa-
tive crop belonging to a given crop group under 40 CFR 180.34(f) to allow
the establishment of a crop group tolerance. If residues are detectable in
or on the RAC or if concentration in processed products is possible, then
processing studies will also be required. In general, the procedures de-
scribed under OPPTS 860.1340 should be used for guidance making cer-
tain that a representative of each major formulation class is tested accord-
ing to the proposed use pattern. Note that the words pesticide and chemical
under OPPTS series 860 are assumed to include MPCAs for purposes of
guideline series 885. Residue increases and/or decline in or on crops will
frequently be a function of growth or replication cycles of the MPCA
which, in turn, is a function of the population dynamics of potentially
numerous other organisms such as the host, the plant site (if different from
the host), other parasites/pathogens of either the host or the MPCA itself,
or competing occupants of the same or a similar habitat. It is expected
that environmental conditions will play an even greater role in the mag-
nitude of MPCA residues in or on plants than in the case of conventional
chemical pesticides. Therefore, adequate geographic representation of test
sites is imperative; refer to USDA's Agricultural Statistics (GPO), pub-
lished annually, for the most recent state production figures for various
crops. Note that in OPPTS 860.1340 it is stated that a processing study
utilizing radiolabeled material may be required if processing of the RAC
could result in alteration of the residue; in the case of an MPCA,
radiolabeling will rarely be either possible or of utility and, therefore, other
approaches must be used.
(c) Additional information requirements.In addition to the above
information and the residue data itself, the following materials and proce-
dural details must be provided: Location of test, application rate (weight
or volume of product/A and number of viable microbes/A, etc.), formula-
tion used, part of crop analyzed, number of samples, sampling procedure,
planting time (date), application dates, harvest/sampling date(s), applica-
tion method, stage of crop at application and harvest, analytical method
used, untreated control data, recovery data, and sample storage time and
conditions.
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