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) Scopeó(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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