United States       Prevention, Pesticides     EPA712-C-96-293
          Environmental Protection    and Toxic Substances     February 1996
          Agency        (7101)
&EPA   Microbial Pesticide
          Test Guidelines
          OPPTS 885.1200
          Manufacturing Process

     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

     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,    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 885. 1200 Manufacturing process.
     (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 are OPP guidelines 151A-1  and  151A-

     (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. Each application for registra-
tion  of a manufacturing-use product or end-use product shall contain a
description of the basic manufacturing process. The starting and intermedi-
ate materials should be  listed (including  EPA Registration No.  and/or
source and purity)  together with the  steps taken to ensure the  integrity
of these materials, and the steps taken to limit the  extraneous  contamina-
tion, both chemical and  biological, in preparations of the unformulated
MPCA. This description shall include the procedures used by the manufac-
turer to establish the identity  and purity  of the culture from which the
unformulated MPCA is produced, the method of manufacture, and tech-
niques used to ensure a uniform or standardized  product. The  integrity
of the product as determined by  specific and sensitive chemical, serologi-
cal or biological tests is to be demonstrated. If the test is not a recognized
standard test, a detailed description of the  test  together with information
regarding precision, specificity, interfering substances,  accuracy, and sen-
sitivity must be provided.

     (c) Maintenance of samples. A sample of registered MPCAs  is to
be maintained on deposit in a nationally recognized culture collection. A
large initial batch could  be preserved in small aliquots to serve  as seed
stock for subsequent batches. This would minimize contamination and var-
iation (chromosomal and extrachromosomal) caused by serial  passage. If
the MPCA produces a toxin,  this may need to be monitored as a form
of quality control.