United States Environmental Protection Agency Office of Chemical Safety

and Pollution Prevention (7101) EPA 712

- C

- 11

- 001

DRAFT

– December 29, 2010



# Microbial Pesticide

Test Guidelines

O CSPP 885.1250 : Deposition of a Sample in a Nationally Recognized

Culture CollectionN OTICE

This guideline is one of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention ( OC S PP ), United States Environmental Protection Agency

, 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).

The OCSPP test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intend ed 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. The procedures contained in this guidelin e 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 I dentification Numbers EPA

- HQ

- OPPT

- 2009

- 0150 through EPA

- HQ

- OPPT

2009

- 0159, and EPA

- HQ

- OPPT

- 2009

- 0576.O C S PP 885. 12 5 0 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 source material originally used in developing harmonized OPPTS test guideline 885 .1200

, from which this guideline ( 885.1250 ) was taken

, is OPP guideline 151A

– 1 1 , as published in July 1989

.

The original data requirements for microbial pesticides , as described in the proposed Part 158 pesticide data requirements regulation ( 47 FR 5319 1

, November 24,

1982 ) , include s a requirement for submission of microbial pesticide samples to an EPA repository. This continues to be a 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, how ever, was not deleted until the Part 158 data requirements rule was revis ed and published in 2007 ( 72 FR 60988

, October 26, 2007 )

. In the preamble to t he proposed rule for these revised data requirements ( 71 FR1 1 2072

, March 8, 2006 ), EPA explained that the submittal of samples data requirement had been replaced by the require ment 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 ( g uideline 885.1200).

Since the Agency does not have capacity to store the variety of microbia l 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 refe r 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 wo uld 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 O CS PP 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 new registration of a Microbial Pest Control Agent ( MPCA ) active ingredient by a company be identified uniquely and deposited in a culture collection by that company. This will en sure that any potential variation from the original source microorganism is accounted for and is the responsibility of the registrant for that active ingredient.

(b) Maintenance of samples. A sample of each r egistered 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 responsibility of the registrant to ensure that their a ctive i ngredient remains on deposit as long as they maintain their registration or experimental use permit . If it is no longer in a culture collection, they must redeposit a sample that is representative of the isolate they originally registered and notify the Agency of the new number

. The deposition num ber would be included in the C onfidential S tatement of F ormula

. This number, however, would not have to be on the label unless it is also used as the company unique identifier for the MPCA 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.

(c) Reference. The following reference provides information on what would constitute a “recognized” culture collection that would provide assurance for continuing maintenance of a culture deposit :

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://ww w.wipo.int /

.