[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Notices]
[Pages 47592-47594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19427]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0255; FRL-8412-4]


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.

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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: [email protected].
    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: [email protected].

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

[[Page 47593]]

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.

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    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.


    Dated: July 28, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

[FR Doc. 2010-19427 Filed 8-5-10; 8:45 am]
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