United States
Environmental Protection Agency
Office of Chemical Safety
and Pollution Prevention
(7101)
EPA 712-C-12-027
April 2012

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, et seq.), 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.epa.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, Ill., 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://www.wipo.int/.