United States Prevention, Pesticides EPA712-C-96-308
Environmental Protection and Toxic Substances February 1996
Agency (7101)
&EPA Microbial Pesticide
Test Guidelines
OPPTS 885.2550
Magnitude of Residues
in Meat, Milk, Poultry,
and Eggs
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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 885.2550 Magnitude of residues in meat, milk, poultry, and
eggs.
(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-11.
(b) Guidance for microbial pest control agents (MPCAs). Gen-
erally, the guidance presented in OPPTS 860.1340 is applicable to MPCAs
under OPPTS Series 885 noting that, again, the word pesticide is assumed
to include MPCAs. If residues of toxicological concern occur in animal
tissues, milk, or eggs following oral dosing in the animal metabolism stud-
ies, feeding studies are required reflecting Ix, 3x, and lOx the maximum
expected dietary intake of MPCA residues occurring in or on feed items.
Animals must generally be dosed for 28 days and slaughtered within 24
hours of the final dose. If pathogenicity, toxicity, or very slow growth
and/or disease development is a problem, appropriately shorter or longer
feeding periods or perhaps even longer preslaughter intervals may be used,
preferably in consultation with Agency scientists. The key issue is timing,
i.e. the maximum residue/MPCA concentrations in tissues, milk, and eggs
must be determined in order to allow the tolerances and, perhaps,
preslaughter intervals, to be established. Similarly, if residues occur in ani-
mals following a direct animal treatment (if proposed) as determined in
an animal metabolism study, studies utilizing typical end-products (EPs)
must be conducted according to the proposed use directions; such treat-
ments could be feed-through, dermal, or otherwise. If two or more routes
of exposure are possible, a single study combining both routes is accept-
able if the health of animals is not affected. Note that the petitioner may
find it advantageous to combine the animal metabolism studies (OPPTS
885.2250) and the feeding/direct animal treatment studies.
(c) Reporting study results. The dosage rate must be clearly stated.
In the case of a feeding study, parts per million of nonviable residues
and enumeration of viable residues (colony- or plaque-forming units or
infectivity units/unit weight of feed or per unit weight per day) as well
as the weights of animals must be provided. In the case of direct-animal
treatments (oral, dermal, or otherwise), the weight or volume of product
(typical EP) and the number of viable MPCAs per unit weight, surface
area, etc. of animal must be provided. Generally, ruminant and poultry
studies are required if residues of toxicological concern occur in feeds
or if direct animal treatments are proposed. Swine studies may also be
required if there is any reason to expect higher residues and/or more rapid
MPCA replication in swine than in poultry or ruminants. If agricultural
premise treatments are proposed studies may be required to demonstrate
the magnitude of the residue in animals following these uses. All tissues
used as food must be sampled; eggs and milk must be sampled twice daily.
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Sample storage time and conditions must be provided as well as the iden-
tity of the analytical methods used, recovery data, and control animal data.
Also, the formulation used and number of samples must be presented.
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