EPA 730-N-00-004
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I.
II.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
Pesticide Registration (PR) Notice
2000-7
NOTICE TO MANUFACTURERS, PRODUCERS,
FORMULATORS AND REGISTRANTS
OF PESTICIDE PRODUCTS
OFFICE OF
PREVENTION. PESTICIDES AND
TOXIC SUBSTANCES
ATTENTION: Persons Responsible for Federal Registrations and Re-registrations of Pesticides.
SUBJECT: The Non-Dietary Exposure Task Force
Introduction
This PR Notice announces an industry-wide task force to jointly develop residential indoor
exposure data for pesticides containing one or more of the active ingredients synthetic
pyrethroids, pyrethrum and synergists. This Notice explains why these data are being developed
and how registrants may wish to participate in the development of these data by joining the Task
Force. The Notice identifies an Environmental Protection Agency (EPA) and a Task Force
contact for persons wanting further information.
The Federal Food, Drug, and Cosmetic Act (FFDCA) Requirement To Consider Available
Exposure Information
The FFDCA requires EPA to consider available information concerning dietary and non-dietary
routes of exposure when assessing a pesticide's residue risks, especially to children. The Non-
Dietary Exposure Task Force ("Task Force" or "NDETF") was formed in July, 1997 to jointly
develop residential indoor exposure data on pesticides containing synthetic pyrethroids,
pyrethrum and synergists (through the representative synergist piperonyl butoxide) as active
ingredients ("the active ingredients"). NDETF data, once developed, will be one form of
available data that may inform decisions on pesticide residue tolerances as well as registration
and reregistration activities for pyrethroids as well as other active ingredients to which the data
may relate. Applicants and registrants seeking to rely on NDETF to satisfy any applicable EPA
data submission requirements must comply with the applicable provisions of section 3(c)(l)(F)
and 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regarding
data compensation.
III. Residential Indoor Exposure Data
The N DETF, in consultation with scientists from EPA, the California Environmental Protection
Agency (Cal-EPA), Canada's Pest Management Regulatory Agency (PMRA) and the Health
Safety Executive (UK), has designed, through pilot studies, a program to assess the
transferability of the active ingredients following different types of applications. The studies will
utilize standardized application methods, validated analytical methods and measure
transferability and photodegredation on carpet and vinyl flooring surfaces. While the class of
active ingredients referred to as synthetic pyrethroids includes a spectrum of substances, the
Recycled/Recyclable . Printed wRh Vegetable OH Based Inks on 100% Recycled Paper (40% Postconsumer)
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NDETF intends to test a range of synthetic pyrethroids that could be representative of the class in
addition to the Task Force's testing of pyrethrum and piperonyl butoxide.
EPA will consider relevant, available information regarding dietary and non-dietary routes of
exposure as part of a registration application or amendment, a reregistration eligibility
determination or a pesticide residue tolerance assessment. EPA has relatively few studies
assessing indoor exposure to pesticides. In the absence of studies that can be used to accurately
assess such exposures, EPA will use appropriate estimates or other modeling to assess potential
exposures. The development of indoor exposure studies would likely provide EPA with a more
accurate tool for assessing these exposures. In some instances, EPA may in the future determine
that development of indoor exposure data is in fact necessary to support applications, existing
registrations, or tolerance assessments (and reassessments). Pesticide registrants and applicants
wishing to develop such data may wish to participate in the NDETF.
Any pesticide registrants or applicants who believe they may need to satisfy indoor residential
exposure requirements in the future or believe such data may better inform EPA's assessments
may wish to presently join the Task Force. Should EPA impose a requirement to submit or cite
indoor residential exposure data or should an applicant or registrant otherwise rely on NDETF
data [to support or maintain registration], a registrant or applicant electing to participate in
NDETF's study, must at the appropriate time, inform the agency of its election of this option and
provide evidence of its membership in the Task Force or evidence that it has complied with any
applicable data compensation requirements. In accordance with FIFRA, in the event that the
NDETF and a non-member who cites to NDETF's data to satisfy a data submission obligation
are unable to reach agreement, the terms and amount of compensation shall, upon the request of
either party, be determined by binding arbitration, as provided in sections 3(c)(l)(F) and
3(c)(2)(B) of FIFRA.
TV. Current Members
Current Members of the Task Force are Aventis Environmental Science (formerly AgrEvo
Environmental Health), Botanical Resources Australia, Ltd., Endura S.p.a., McLaughlin
Gormley King Company, Premiss Incorporated, Pyrethrum Board of Kenya, S.C. Johnson &
Son, Inc., and Takasago International.
V. Joining the NDETF
The Agency is not a participant in the NDETF but is available as the Agency deems appropriate
to provide guidance and assistance relating to the development of the data. As noted, the Agency
and other regulatory authorities have provided input to the NDETF. The following information
was supplied to EPA by the NDETF for the benefit of registrants and applicants of the active
ingredients interested in joining the Task Force: The NDETF is organized under a FIFRA joint
data development agreement with certain common developmental costs shared equally among all
registrants and certain costs shared according to the number active ingredients registered by the
registrant. Membership is available for a period of six months from the date of issuance of this
PR Notice upon payment of an appropriate share of prior member assessments, adjusted for
interest. Thereafter, membership is available by paying an appropriate share of all assessments,
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interests and certain late fees. Each participating company has the right to appoint one
representative to the Steering Committee and the Technical Committee of the NDETF Those
desiring further information on the Task Force niay contact the following:
Paul Keane, Chairman, Steering Committee, Non-Dietary Exposure Task Force 47 West
Division Street, Suite 389, Chicago, IL 60610.
Phone: (312)664-4781 •
Fax: (312)664-0728
Email: Pkeane2100@aol.com
Tom Osimitz, Ph.D., Chairman, Technical Committee, Non-Dietary Exposure Task
Force, S.C. Johnson & Son, Inc., 1525 Howe Street, M.S. 122 Racine WI 53403
Phone:(414)260-2669
Fax: (414)260-0186
Email: tgosimit@scj.com
VI. What the NDETF Will Do
The work product expected to be developed and submitted by and through the NDETF will
include but is not limited to the following study reports for the active ingredients that are the
subject of the program:
Method Development for Measurement of Transferable Residues from Vinyl Flooring
and Carpet Using the Indoor Roller.
Method Development for Measurement of Transferable Residues from Vinyl Flooring
and Carpet Using the Drag Block/Drag Winch.
Measurement of Residue Transfer of Active Ingredients From Treated Carpet and Vinvl
Flooring to Human Hands.
Fate of Active Ingredients in a Household Spray Formulation Exposed to Various Indoor
and Outdoor Lighting Conditions.
Post-Application Deposition Measurements for Active Ingredients Following Use of a
Total Release Indoor Fogger.
It is possible that the program will include additional study reports and it is possible that certain
use patterns, uncommon formulations, or other situations may arise for which EPA might require
separate indoor residential exposure data from an applicant or a registrant that would not be
available through the work performed by the Task Force.
This PR Notice is issued by the Agency for the sole purpose of informing pesticide registrants
and applicants of the formation of the NDETF. It is not intended to define or restrict the terms of
or subsequent amendments to the joint data development agreement and its operation
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VII. For Further Information
For questions or further information regarding the NDETF, please contact Alan Dixon at
(703) 305-7237.
Signed:
ia E. Mulkey, Director Office of Pesticide Programs
Dated:
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