Final Test Guideline; Product Performance of Skin-applied Insect Repellents of Insect and Other Arthropods (OPPTS Test Guideline No. 810.3700); Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is announcing the availability of the final test guideline for Product Performance of Skin-applied Insect Repellents of Insect and Other Arthropods Test Guidelines (OPPTS Test Guideline No. 810.3700).

FOR FURTHER INFORMATION CONTACT:

For general information contact: Melissa Chun, Regulatory Coordination Staff (7101M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-1605; e-mail address: chun.melissa@epa.gov.

For technical information contact: Clara Fuentes, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-0171; e-mail address: fuentes.clara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Introduction

This test guideline is part of a series of test guidelines (referred to hereinafter as the harmonized test guidelines) established by the Office of Chemical Safety and Pollution Prevention (OCSPP) (formerly the Office of Prevention, Pesticides and Toxic Substances (OPPTS) prior to April 22, 2010) 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 harmonized 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 harmonized test guidelines provide guidance for conducting the test, and are also used by EPA, the public, and the companies that are subject to data submission requirements under TSCA, FIFRA, and/or the FFDCA.

As guidance documents, the harmonized test guidelines are not binding on either EPA or any outside parties, and EPA may depart from the harmonized test guidelines where circumstances warrant and without prior notice. The procedures contained in the harmonized test guidelines are recommended for generating the data that are the subject of the harmonized test guidelines, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in the harmonized 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. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket for this document. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0255. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

2. Electronic access to the harmonized test guidelines. To access the harmonized test guidelines electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” You may also access the harmonized 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 harmonized test guideline under OPPTS Series 810, entitled “Product Performance of Skin-applied Insect Repellents of Insects and Other Arthropods” (OPPTS Test Guideline No. 810.3700). The updated harmonized test guideline recommends methods for conducting product performance testing of topically applied repellents of insects and other arthropods. As a guideline, it does not impose mandatory requirements. It does, however, reflect the Agency’s consideration of recommendations for steps necessary to develop reliable data on performance of skin-applied arthropod repellent products, and recommends procedures to follow when human subjects are involved. The section of the existing 1999 draft OPPTS Test Guideline No. 810.3700 applying to repellents for use in outdoor premises will remain in effect.

EPA will continue to consider refinements and new test methods as they become available. In addition, the Agency will add recommended test methods for other types of arthropod repellents such as those impregnated into clothing or other fabrics or for repelling insect pests in outdoor spaces. These additional guidelines will be published for public comment at a later time.

Studies conducted according to these harmonized test guidelines may be used to address data requirements for pesticide registrations defined at 40 CFR 158.400, 158.2070, and 158.2160. These harmonized test guidelines may also be useful for satisfying FIFRA data requirements for data call-ins issued under the authority of FIFRA section 3(c)(2)(B).

B. How Were These Harmonized Test Guidelines Developed?

The Agency has been working to revise this Product Performance Test Guideline since it was published as a “public draft” in December 1999. EPA held a meeting of the FIFRA Scientific Advisory Panel (SAP) on the revised draft guideline in April 2000. Revised drafts addressing only repellents for topical application to human skin were presented to the Human Studies Review Board (HRSB) in June 2006 and in October 2008. The HSRB has reviewed and commented on numerous protocols for insect repellent efficacy studies and reports of completed studies. Over the course of these reviews the HSRB has made suggestions for further strengthening the scientific and ethical conduct of this kind of research; these have been incorporated into the updated harmonized test guideline. A response-to-comments document has been placed in the docket showing how the recommendations of the advisory committees have been reflected in the harmonized test guideline.

The Agency also convened a public meeting, that was announced in the Federal Register of June 13, 2007 (72 FR 32647) (FRL-8135-9), of national experts in which the revisions made in June 2006, were discussed. The public meeting, “Workshop for Sharing Technical Information on Updated Methods for Testing Efficacy of Skin-Applied Insect Repellents,” involved leading scientists from the public and private sectors who conduct this type of research.

As a result of these various consultations and public comment opportunities, EPA has revised its topical insect repellent efficacy test guideline in response to the helpful suggestions from the various scientific and ethics experts and comments received from the public.

This updated harmonized test guideline contains new sections addressing ethical considerations affecting the design and conduct of repellent studies when human subjects are involved. Any research conducted under this harmonized test guideline is covered by the requirements of EPA’s regulations for the protection of human subjects of research set out at 40 CFR part 26, subparts K, L, and M. Persons conducting and submitting topical repellent efficacy studies should ensure compliance with all applicable requirements of that rule.

EPA has also expanded and revised the sections dealing with scientific aspects of this kind of study. This harmonized test guideline provides specific recommendations for the design and execution of studies to evaluate the performance of pesticide products intended to repel insects and other arthropods in connection with the products’ registration under FIFRA. This harmonized test guideline applies to products in any formulation—such as lotion, liquid, or spray—intended to be applied directly to human skin. It does not apply to products applied to or impregnated in clothing or fabric, or used to repel insects from indoor or outdoor spaces. This harmonized test guideline recommends appropriate study designs and methods for selecting subjects, statistical analysis, and reporting.

EPA recognizes that the World Health Organization (WHO) has also published guidelines for testing efficacy of skin-applied mosquito repellents. The purpose of the WHO guidelines is to provide procedures and criteria for efficacy testing of mosquito repellents applied to human skin. EPA’s harmonized test guidelines coincide with the WHO guidelines in providing guidance for laboratory and field tests. Both guidelines recommend field testing, monitoring test sites, and establishing criteria for acceptable landing pressure. EPA considered the WHO guidelines during the development of its own guidelines.

List of Subjects

• Environmental protection
• Chemical testing
• Harmonized test guidelines
• Pesticides and pests