vvEPA
ii •* ,1 o* t Office of Chemical Safety ,-DA -,.~ „ .0 no-,
SSnmenta, Protection Agency $™*™ P-ention ^720?2C-12-°27
Microbial Pesticide
Test Guidelines
OCSPP 885.1250:
Deposition of a Sample in
a Nationally Recognized
Culture Collection
-------
NOTICE
This guideline is one of a series of test guidelines established by the United
States Environmental Protection Agency's Office of Chemical Safety and Pollution
Prevention (OCSPP) for use in testing pesticides and chemical substances to develop
data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15
U.S.C. 2601, etseq.), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
(7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA) (21 U.S.C. 346a). Prior to April 22, 2010, OCSPP was known as the Office of
Prevention, Pesticides, and Toxic Substances (OPPTS). To distinguish these
guidelines from guidelines issued by other organizations, the numbering convention
adopted in 1994 specifically included OPPTS as part of the guideline's number. Any
test guidelines developed after April 22, 2010 will use the new acronym (OCSPP) in
their title.
The OCSPP test guidelines serve as a compendium of accepted scientific
methodologies and protocols that are intended to provide data to inform regulatory
decisions under TSCA, FIFRA, and/or FFDCA. This document provides guidance for
conducting the test, and is also used by EPA, the public, and the companies that are
subject to data submission requirements under TSCA, FIFRA, and/or FFDCA. As a
guidance document, these guidelines are not binding on either EPA or any outside
parties, and the EPA may depart from the guidelines where circumstances warrant and
without prior notice. At places in this guidance, the Agency used the word "should." In
this guidance, the use of "should" with regard to an action means that the action is
recommended rather than mandatory. The procedures contained in this guideline are
strongly recommended for generating the data that are the subject of the guideline, but
EPA recognizes that departures may be appropriate in specific situations. You may
propose alternatives to the recommendations described in these guidelines, and the
Agency will assess them for appropriateness on a case-by-case basis.
For additional information about OCSPP harmonized test guidelines and to
access the guidelines electronically, please go to http://www. gov/ocspp and select
"Test Methods & Guidelines" on the navigation menu. You may also access the
guidelines in http://www.regulations.gov, where they are grouped by Series under
Docket Identification Numbers EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-
2009-0159, and EPA-HQ-OPPT-2009-0576.
-------
OCSPP 885.1250: Deposition of a sample in a nationally recognized culture
collection.
(a) Scope—
(1) Applicability. This guideline is intended to meet testing requirements of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.).
(2) Background. The original data requirements for microbial pesticides, as
promulgated in 1984 (49 FR 42856, October 24, 1984), include a conditional
requirement for submission of microbial pesticide samples to an EPA repository in
Beltsville, Maryland. This continues to be a conditional requirement for chemical
pesticides, but it was soon recognized that the EPA pesticide repository did not have
the special equipment and expertise to properly preserve these living organisms. This
data requirement, however, was not clarified until the Part 158 data requirements for
biochemical and microbial pesticides were revised and published in 2007 (72 FR 60988,
October 26, 2007). In the preamble to the proposed rule for these revised data
requirements (71 FR 12072, March 8, 2006), EPA explained that the submittal of
samples data requirement had been replaced by the requirement to maintain a sample
in a nationally recognized culture collection:
Submittal of samples. This provision is typically intended to enable EPA
to identify the active ingredient and provide standards to governmental
agencies needing to monitor chemical pesticide residues and is
conditionally required (CR). The Agency proposes to require (R) these
data as a product analysis requirement to be deposited in a nationally
recognized culture collection to allow EPA to validate strain identity if
issues arise (guideline 885.1200).
Since the Agency does not have capacity to store the variety of microbial
pesticides that may be submitted, EPA did not set up a nationally
recognized culture collection. There are several nationally recognized
culture collections in this country (and abroad) such as the American Type
Culture Collection (ATCC) and a microbial collection maintained in Peoria,
III., by the USDA. These facilities have a vast number of microbial and cell
cultures that [the facilities] are dedicated to transferring, maintaining and
identifying. Rather than duplicate this effort, EPA chose to refer microbial
pesticide producers to these facilities who have the routine expertise to
keep and distribute (or protect) microbial cultures. There is a certain
element of required expertise but really the cost and small number of our
microbial pesticides would make it prohibitively expensive for the Agency
to do this collection rather than direct the companies to these specialized
facilities.
This new guideline (885.1250) also includes information, taken from OCSPP
guidance for specific products, to better explain how to best "maintain a sample on
-------
deposit in a nationally recognized culture collection." Because of the potential for
microorganisms to gain or lose active pesticidal properties, or to acquire other risk
factors due to mutations or due to natural transfer or loss of genetic material, it is
essential that each microbial pesticide active ingredient be identified uniquely and
deposited in a culture collection by the registrant of that microbial pesticide. This will
enable the Agency to determine whether marketed pesticides vary from the original
source microorganism and to hold the registrant accountable for the product
composition, where appropriate.
3) Source. The source material originally used in developing harmonized OPPTS
test guideline 885.1200, from which this guideline (885.1250) was taken, is OPP
guideline 151A-11, as published in July 1989.
(b) Maintenance of samples. A sample of each registered microbial pesticide active
ingredient is to be maintained on deposit in a nationally recognized culture collection.
The sample of the active ingredient would best be deposited as a culture with a
maintenance agreement, such as in the American Type Culture Collection (ATCC)
Patent Collection, so that there is no chance the culture collection will discard it. It is the
responsibility of the registrant to ensure that its active ingredient remains on deposit as
long as it maintains the registration or experimental use permit associated with that
microbial pesticide active ingredient. If it is no longer in a culture collection, the
registrant must redeposit a sample that is representative of the isolate that was
originally registered and notify the Agency of the new number. The deposition number
would be included in the Confidential Statement of Formula. This number, however,
would not have to be on the label unless it is also used as the company unique identifier
for the microbial pesticide active ingredient. The culture collection deposit does not
have to be available to the public for obtaining a sample, but a sample must be
available to be sent to EPA, if requested.
Article 6 of the Budapest Treaty on the International Recognition of the Deposit of
Microorganisms for the Purposes of Patent Procedure (Budapest Treaty, 1980) provides
information on what would constitute a "recognized" culture collection that would provide
assurance for continuing maintenance of a culture deposit:
(1) Have a continuous existence;
(2) Have the necessary staff and facilities, as prescribed in the Regulations, to
perform its scientific and administrative tasks under this Treaty;
(3) Be impartial and objective;
(4) Be available, for the purposes of deposit, to any depositor under the same
conditions;
(5) Accept for deposit any or certain kinds of microorganisms, examine their
viability and store them, as prescribed in the Regulations;
(6) Issue a receipt to the depositor, and any required viability statement, as
prescribed in the Regulations;
(7) Comply, in respect of the deposited microorganisms, with the requirement of
secrecy, as prescribed in the Regulations;
-------
(8) Furnish samples of any deposited microorganism under the conditions and in
conformity with the procedure prescribed in the Regulations.
(c) Reference. Budapest Treaty on the International Recognition of the Deposit of
Microorganisms for the Purposes of Patent Procedure. Done at Budapest on April 28,
1977 and amended on September 26, 1980. Available from the World Intellectual
Property Organization at http^ft/wv\nMpo.int/.
------- |