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

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 Office of 

Chemical Safety and Pollution Prevention (OCSPP), 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 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. 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-OPPT2009-0159, 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 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.

The original data requirements for microbial pesticides, as described in the 

proposed Part 158 pesticide data requirements regulation (47 FR 53191, November 24, 

1982), includes 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, however, 

was not deleted until the Part 158 data requirements rule was revised and published in

2007 (72 FR 60988, October 26, 2007). In the preamble to the proposed rule for these 

revised data requirements (71 FR1 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 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 ensure 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 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 responsibility of the registrant to ensure that their active ingredient 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 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 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://www.wipo.int/.