US Environmental Protection Agency
Office of Pesticide Programs
Pesticide Registration (PR) Notice 2011-1
Residential Exposure Joint Venture
January 3, 2011

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Pesticide Registration (PR) Notice
2011-1
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS AND
REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION: Persons Responsible for Federal Registrations and Re-evaluations (Re-
registration and Registration Review) of Pesticides.
SUBJECT: Residential Exposure Joint Venture
I,	Introduction
This PR Notice is to advise registrants of an industry-wide joint venture, titled the Residential
Exposure Joint Venture (REJV). which has developed a national survey regarding residential
consumei use/usage data for pesticides which help form the basis for exposure assessments. The
RF.J V is planning to conduct a similar survey to update the existing data to reflect current trends.
This Notice explains why these data were developed, discusses plans for additional data
development, and indicates how registrants who may wish to rely on and/or participate in the
development of these data mav join the REJV. The Notice identifies Environmental Protection
Agency ( iPAj and REJV contacts for persons wanting further information.
II.	The use of REJV data under the Federal Pesticide Regulatory Scheme
The Federal Food. Drug and Cosmetic Act (FFDCA) requires EPA to consider available
information concerning dietary and no'i-dictary exposure when assessing a pesticide's risks,
especially to children. The ev aluation of potential pesticide exposures in and around residences
presents unique challenges due to the complex and dynamic nature of this environment.
Exposures can occur because product application and human activities overlap in affected
microenvirenments but such exposures can vary because pesticide use and human behaviors
rest:It in exposure that differs on both a spatial and temporal basis. Residential exposure to
pesticides mav involve multiple sources because a product is used in more than one way in a
residence. Similarly, more than one ptoduct containing the same active ingredient may be used.
These difletences can result in multiple exposure sources from different exposure pathways and
through diftcrent routes of exposure. Potential exposure pathways include treated lawns or
indoors sources. Routes of exposure include dermal exposure through contact and oral ingestion
through the mouthing behaviors of children.
The REJV was formed in August 1997 to collect, organi/.e and analyze label and use information
for pesticide products used in and around the home. This information aids in the conduct of
exposure assessments for the use scenarios associated with specific pesticide active ingredients
including how to aggregate their exposures as appropriate across routes and pathways. It has
also been used to assist with the development of cumulative risk assessments under the FFDCA
for classes of chemicals that share a common mode of toxicologicai action which requires
combining exposures for all chemicals in the class.
An important part of HPA's regulatory process is having information to determination how a
pesticide is used in household settings and its ability to characterize exposures associated with
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that use. For example, consider a pesticide that is applied, by a certain fraction of U.S.
households to control pests indoors and also applied by yet another group of users to control
pests outside their homes. Certain households use the pesticide for boih types of applications.
For products registered exclusively for indoor use, the use determination is fairly
straightforward. However, for some proportion of U.S. households, outdoor uses may also occur
resulting in multiple product applications and/or potential post-application exposure scenarios
resulting in ov erlap or "co-occurrence" across time which indicates multiple types of exposures
have to be appropriately considered. This example illustrates why determination of residential
use and exposure characterization is an important part of FPA's regulatory process. Further,
without a firm basis for estimating potential co-occurrence of pesticide product use and
exposures F;5A cannot conduct refilled probabilistic aggregate and cumulative risk analyses.
FPA believes that product use information over time as developed by the RFJV' has and will
continue to be an important part of EP/Vs risk assessments, including its probabilistic aggregate
and cumulative assessments
Without reliable product data regarding how and how often a product is used (use and usage
information^. LiPA's residential and consumer product assessments must instead rely on "default"
assumptions regarding product usc-rek.ted input variables used (o estimate potential applicator
(handler) and post-application exposures, RHJV's objective for its original •survey as well as its
future efforts was and is to survey consumers to develop a comprehensive database of residential
use and exposure data on consumer pesticides to provide FPA with real world use information
that allows the Agency to refine its assessments. Applicants and registrants seeking to rely on
RFJV data to satisfy an\ applicable FPA data submission requirements, including the
development of related exposure models, must comply with the applicable provisions of sections
3(c)(1)(F) and .1(c)(2)(B) of the Federal Insecticide. Fungicide, and Rodenticide Act (F1FRA)
regarding d?ta compensation.
III. Objectives of the REJV
This information is provided by the REJV to describe both its past and future planned efforts to
provide U.S. and international pesticide regulators with reliable, real world residential product
use inforrna ion. The RFJV obtained input from the FPA, California FPA and Canada PMRA in
its cevelopment and conduct of a calendar or diary-based survey (May 2001 - April 2002) to
determine the demographics and spatial (geographic) characteristics of households using the
products, and temporal use information (beyond currently available label information). These
data include an assessment of residential characteristics, area of residence treated, amount of
product used over time and per treatment, pests treated, and product use co-occurrence. "Flic goal
was to obtain basic information about pesticide product use in and around residential sites in a
form that permits "mapping" individual and concurrent product use events o\er lime. The
duration of the original survev instrument was 12 months. The survey design prov ided a
nationally representative "static'" sample of households during the 12 month time period. The
RFJV has a so created an information management system that houses both label- and use-
related information. The major objectives of the system included the following:
•	Provide key label related information (from FPA's Pesticide Product Information System)
such as registration number, formulation type. % A.I., application method and rate, area
treated, use instructions, precautionary statements, etc.). that can be cross-referenced with
•	Survey-based use information such as EPA registration number, product name, application
method, date of application, frequency and timing of use, site of application, and user
demographics generated through the conduct of the 12-inonth diary survey program.
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Regulators changes that have taken place since the completion of the REJY survey in 2001 (such
as the remo\ai of various Organophosphates and Carbamates from residential uses) and the
subsequent market and consumer adjustment to find replacement pesticides, have resulted in
significant c.ianges in use and usage patterns, especially for pyrethroids. Therefore, the REJV is
planning to conduct a similar suney to "refresh" the existing data to reflect current trends and
chemistries.
IV.	Use of Residential Exposure Surveys in Connection with EPA Regulatory Actions
FPA considers re!e\ant, available use information to inform its non-dietary exposure assessments
as part of a registration application or amendment, as well as in the re-registration and
registration review process. EPA has relatively few surveys or studies assessing product use
information in and around residences that can specifically inform residential exposure
assessments to pesticides, hi the absence of reliable data that can be used to accurately assess
procuct use md inform such exposures, EPA will use appropriate, protective estimates,
modeling, 01 assumptions to assess potential exposures. The development of consumer
housebote product use and usage information by REJV has provided EPA with a more accurate
basis for r.ss;ssing these exposures in some instances. EPA expects to have a continuing need for
such information, including updated surveys that better reflect current usage. For this reason, the
Agency expects that it will require submission or citation of such data in connection with
upcoming registration reviews and other regulatory actions.
Any pestiiice registrants or applicants who believe they may need to satisfy these data
requirements ma}' wish to consider participation in the REJV. When EPA imposes requirements
to submit or cite product use/usage data, the registrant or applicant electing to rely on REJV data
must, at the appropriate time, inform the agency of its election of this option and provide
evidence :>f its membership in the REJV or certify that it has offered to compensate the REJV for
reliance on their data in accordance with EPA regulations, in the event that the REJV and a non-
member \>ho cites REJV 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)(1 )(F> and 3(c)(2)(B) of FIERA.
V.	Current Members
Cuivent Members of the REJV are: BASF, Bayer Environmental Science, McLaughlin Gormley
King Company, S.C. Johnson & Son, inc., Syngcnta, Inc., United Industries, and Valent
Biosciences
VI.	Contacting the REJV
Those desiring further information on the Task Force may contact the following:
Stuart McArthur. Chairman. Steering Committee, Residential Exposure Joint Venture, S.C.
Johnson & Son, inc.. 1525 Howe Street, VI,S. 149, Racine. WI 53403.
Phone: (414)260-2405
Fax: (414) 260-4716
Email: sc iicarth'Sscj.com.
Susan Little. Executive Chair, Pesticide Ingredient Review Program,
Consumer Specialty Products Association.
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900 l7ih St.. NW. Washington, D.C.
Phone: 262.S72.8! 10
FAX: 202.872.81 14
F.-maii: slittic:t/-C5>pa.oni
VII. Agency Contact
For questions or further information regarding the REJV, please contact:
David J. Mi. let, Chief
Chemistry i.K. Exposure Branch
Health Effects Division
Office of Pesticide Programs
703-305-5352 (voice) "
703-305-5147 (fax)
Dated; December^ 2010
Steven Bradbury. Ph.D., Director
Office of Pesticide Programs
U.S. Fnviro imenta! Protection Agency
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