2019-21043. Final Test Guideline; Series 810-Product Performance Test Guideline; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is announcing the availability of the final product performance test guideline for premises treatments. 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 for testing that are intended to provide data to inform regulatory decisions. This test guideline, which is identified as OCSPP Test Guideline 810.3500, provides guidance for conducting a study to determine pesticide product performance against invertebrate pests of premises and is used by EPA, the public, and companies that submit data to EPA.

FOR FURTHER INFORMATION CONTACT:

Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Introduction

EPA is announcing the availability of a final test guideline, OCSPP Test Guideline 810.3500: Premises Treatments.

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 are 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-2017-0693, 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 [phone], and the telephone number for the OPP Docket is [phone]. 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 810.3500 entitled “Premises Treatments” and identified as OCSPP Test Guideline 810.3500. This revised guideline replaces the original version published in 1998. The guideline provides recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products intended to kill, control, flush, and/or knock down invertebrate pests of premises, such as cockroaches, ticks, mosquitoes, flies, and wasps in connection with registration of pesticide products under the FIFRA (7 U.S.C. 136, et seq.). It does not apply to efficacy testing for treatment of livestock or pets, wide-area mosquito control, structural protection from termites, or bed bug products.

B. How was this final test guideline developed?

EPA-registered pesticide products are an important part of pest management programs for pests of premises. The Agency developed the product performance test guidelines 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 conferences, consulted with leading academics, and reviewed peer-reviewed scientific journal articles on topics related to the guideline to draft the original document. Further, EPA sought advice and recommendations from the FIFRA Scientific Advisory Panel (SAP) and the public. The SAP meeting, held on May 8-10, 2018, was announced in the Federal Register issue of January 26, 2018 (83 FR 3704) (FRL-9972-65). This guideline has been revised based on comments from the SAP and the public. The revisions include clarifying bait product testing, offering more flexibility in testing design, updating the replication recommendations based on statistical modeling and ease of obtaining pests, and refining the statistical analyses recommendations. The Agency is also making available in the docket a Response to Comments document that addresses issue raised in the public comment submission.

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

Dated: September 24, 2019.

Alexandra Dapolito Dunn,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.