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
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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-OPPT2009-0159, and EPA-HQ-OPPT-2009-0576.
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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 
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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;
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(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/.