Final Test Guideline; Product Performance Test Guidelines; OCSPP 810.3900 Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900. This test guideline is part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. The test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions. This test guideline provides guidance for conducting a study to determine pesticide product performance against bed bugs, and is used by EPA, the public, and companies that submit data to EPA.

FOR FURTHER INFORMATION CONTACT:

Michael L. Goodis, P.E., Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

EPA is announcing the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900.

This test guideline is part of a series of test guidelines established by OCSPP for use in testing pesticides and chemical substances to develop data for submission to the agency under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 (21 U.S.C. 346a), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.), and the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.). The 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.

The test guidelines provide guidance for conducting the test, and are also used by EPA, the public, and companies that are subject to data submission requirements under TSCA, FIFRA, and/or FFDCA. As guidance documents, the test guidelines are not binding on either EPA or any outside parties, and EPA may depart from the test guidelines where circumstances warrant and without prior notice. At places in this guidance, the agency uses the word “should.” In this guidance, use of “should” with regard to an action means that the action is recommended rather than mandatory. The procedures contained in the test guidelines are recommended for generating the data that are the subject of the test guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in the test guidelines, and the agency will assess them for appropriateness on a case-by-case basis.

II. General Information

A. Does this action apply to me?

This action is directed to the public in general. Although this action may be of particular interest to those persons who are or may be required to conduct testing of pesticides and chemical substances for submission to EPA under TSCA, FIFRA, and/or FFDCA, the agency has not attempted to describe all the specific entities that may be affected by this action.

B. How can I get copies of this document and other related information?

1. Docket for this document. The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2011-1017, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

2. Electronic access to the OCSPP test guidelines. To access OCSPP test guidelines electronically, please go to http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm. You may also access the test guidelines in http://www.regulations.gov,, grouped by series under docket ID numbers: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159 and EPA-HQ-OPPT-2009-0576.

III. Overview

A. What action is EPA taking?

EPA is announcing the availability of a final test guideline under Series 810.3900 entitled “Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products” and identified as OCSPP Test Guideline 810.3900. This guideline provides recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to repel, attract, and/or kill the common bed bug (Cimex lectularius) in connection with registration of pesticide products under the FIFRA (7 U.S.C. 136, et seq.). This guidance applies to products in any formulation such as a liquid, aerosol, fog, or impregnated fabric, if intended to be applied to have a pesticidal purpose such as to attract, repel, or kill bed bugs. It does not apply to repellent products applied to human skin, and does not apply to those products exempt from FIFRA registration under 40 CFR 152.25.

B. How was this final test guideline developed?

EPA-registered pesticide products are an important part of pest management programs for the control of bed bugs. The agency developed the product performance guideline to standardize the approaches to testing methods to ensure the quality and validity of the efficacy data for these types of products. The agency attended entomology and bed bug specific conferences, consulted with leading bed bug academics, and consulted peer-reviewed scientific journal articles on the issues associated with the guideline to draft the original document. Further, EPA sought advice and recommendations from the FIFRA Scientific Advisory Panel (SAP). The SAP meeting, held on March 6-7, 2012, was announced in the Federal Register issue of January 11, 2012 (77 FR 1677) (FRL-9331-6). The guideline has been revised based on comments from the SAP and the public. The revisions include decreasing the number of individuals and replicates tested, rescinding the recommendation to test each field strain for its resistance ratio and including a resistance management statement, clarifying the agency's Good Laboratory Practices (GLP) requirements, reducing the recommended length of time individuals are exposed to insecticides, recommending individuals to be observed up to 96 hours after treatment, and revising the statistical analyses recommendations.

Authority: 7 U.S.C. 136 et seq.; 15 U.S.C. 2601 et seq.; 21 U.S.C. 301 et seq.