United States Prevention, Pesticides EPA712-C-96-303
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.2250
Nature of the Residue in
Animals
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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 885.2250 Nature of the residue in animals.
(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-7.
(b) Test procedures and reporting of data. (1) If microbial pest
control agents (MPCAs) have been determined to be of toxicological con-
cern, or if residues of concern will be present in or one feed items, animal
metabolism studies must be conducted utilizing ruminants and poultry. If
residues of toxicological concern occur in or on feed items, animals gen-
erally must be dosed orally for at least 3 days with the MPCA terminal
residues in feed items characterized to the extent possible. Note that, theo-
retically, a single MPCA propagule in or on a feed item could cause infec-
tion or allow replication in livestock; obviously, this single viable unit
could be a residue of toxicological concern but would most likely not have
been detected in or on the feed item. Therefore, if any potential for animal
pathogenicity exists, animal metabolism studies will be required in all
cases. If orally or dermally administered direct animal treatments or animal
premise treatments are proposed, animals/premises must be treated accord-
ing to the proposed use directions or at exaggerated rates (if necessary
for residue characterization) using a typical end-product.
(2) If no replication of the MPCA occurs in or on the animal, at
least muscle, fat, kidney, and liver must be analyzed within 24 h of dosage
cessation. If MPCA replication occurs in the animal, several longer inter-
vals may also be required and more extensive tissue sampling will be nec-
essary. Some MPCAs, notably fungi, may require weeks or months to es-
tablish a detectable infection. Eggs and milk, where applicable, must be
sampled at regular intervals, preferably daily. It may be possible to com-
bine the animal metabolism and animal magnitude of residue studies
(OPPTS 885.2500), if required. These studies will allow the determination
of the major residues for which analytical methodology must be developed
and those which must be sought in animal feeding studies, if required.
The efficiency and sensitivity of the utilized methods will also be deter-
mined from these animal metabolism studies.
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