Document ID: EPA-HQ-OPP-2007-0804-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-01-29T05:00Z

Docket Number:  EPA-HQ-OPP-2007-0804

www.regulations.gov

Etofenprox Final Work Plan (FWP)

For Registration Review

January, 2008

 

Approved by:________________________________	 

		Steve Bradbury, Director

		Special Review and Reregistration Division

Date:______________________

Docket Number:  EPA-HQ-OPP-2007-0804

www.regulations.gov

Introduction:

This is the Environmental Protection Agency’s (EPA’s) Final Work
Plan for the registration review of etofenprox.  This work plan includes
the expected registration review timeline.  The work plan also addresses
public comments received concerning the Preliminary Work Plan in the
Summary Document which was posted in the etofenprox registration review
docket, and any other comments concerning initial docket postings.  The
Summary Document provided information on what EPA knows about the
pesticide and what additional risk analyses and data or information the
Agency believes are needed to make a registration review decision.  

The Agency is implementing the new registration review program and will
review each registered pesticide every 15 years to determine whether it
continues to meet the Federal Insecticide Fungicide and Rodenticide Act
(FIFRA) standard for registration.  Changes in science, public policy,
and pesticide use practices will occur over time.  The registration
review program is intended to make sure that, as the ability to assess
risk evolves and as policies and practices change, all registered
pesticides continue to meet that statutory standard.  The public phase
of registration review begins when the initial docket is opened for each
case.  Information on this program is provided at:   HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/_" 
http://www.epa.gov/oppsrrd1/registration_review/ .

Comments Received on Preliminary Work Plan:

EPA received two sets of comments during the public comment period on
the initial etofenprox docket.  However, these comments, which are
addressed in this document, did not change the data and risk assessment
needs or the timeline detailed in the Preliminary Work Plan.  This
document makes final the work plan for the etofenprox registration
review process.  A description of the comments and EPA’s responses to
the comments are in the “Summary of Comments and Agency Responses”
section of this document.

Risk Assessment and Data Needs:

The Agency anticipates conducting an additional ecological risk
assessment under registration review that will include an assessment of
potential risk to endangered and threatened species (“listed
species”) in a manner consistent with agreements between the Agency
and the U.S. Fish and Wildlife Service and the National Marine Fisheries
Service (‘the Services”). The Agency also expects to conduct
additional human health risk assessments for both individual and
aggregate scenarios that include incidental oral exposure.  

	

Docket Number:  EPA-HQ-OPP-2007-0804

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Ecological Risk:

The most recent assessment for etofenprox was completed September 20,
1999.  Also, there have been three previous Section 18 risk assessments
for use on rice in Louisiana and Texas completed March 16, 2006, January
31, 2007, and July 17, 2007.

The Agency foresees needing additional ecotoxicity studies prior to
conducting the planned assessments; however, the Agency is aware that a
full suite of ecotoxicity studies has been submitted and review of these
data is awaiting assessment of the pending Section 3 use on rice, which
should occur in 2008.  Should these studies be acceptable, the Agency
does not foresee the need for additional ecotoxicity data.

Based on the preliminary exposure estimates, previous risk assessment
endpoints, and assumptions, risks (due to direct effects from acute
exposure) are possible to listed aquatic invertebrates.  The available
data for the assessment of acute risk to aquatic animals is currently
limited to freshwater species (i.e., no guideline toxicity data for
estuarine/marine species are available for etofenprox).  

Chronic exposures were not estimated for taxa other than mammals due to
lack of reviewed chronic toxicity data; however, should the submitted
ecotoxicity studies be acceptable, the Agency does not foresee the need
for additional ecotoxicity or environmental fate data.

No reviewed toxicity data are currently available for aquatic or
terrestrial plants; however, should the submitted ecotoxicity studies be
acceptable, the Agency does not foresee the need for additional
ecotoxicity or environmental fate data.  Although etofenprox is
described as an insecticide and is therefore not anticipated to cause
adverse effects to plants, data are needed to determine whether this is
the case or not.  Hence, in the absence of data, risks to species in
these taxa are presumed.

The Agency foresees needing additional environmental fate studies prior
to conducting the planned assessments; however, the Agency is aware that
a full suite of environmental fate studies have been submitted and
review of these data is awaiting assessment of the pending Section 3 use
on rice, which should occur in 2008.  Should these studies be
acceptable, the Agency does not foresee the need for additional data. 
These environmental fate data are needed to adequately 

Docket Number:  EPA-HQ-OPP-2007-0804

  HYPERLINK "http://www.regulations.gov"  www.regulations.gov 

	characterize the environmental fate of etofenprox associated with the
use as an 	outdoor fogger.

The planned ecological risk assessment will allow the Agency to
determine whether etofenprox’s use has "no effect" or "may affect"
federally listed threatened or endangered species (listed species) or
their designated critical habitat.  If the assessment indicates that
etofenprox "may affect" a listed species or its designated critical
habitat, the assessment will be refined.  The refined assessment will
allow the Agency to determine whether use of etofenprox is “likely to
adversely affect” the species or critical habitat or "not likely to
adversely affect" the species or critical habitat.  When an assessment
concludes that a pesticide's use "may affect" a listed species or its
designated critical habitat, the Agency will consult with the U.S. Fish
and Wildlife Service and National Marine Fisheries Service (the
Services), as appropriate.

Human Health Risk:

There are currently no Section 3 food uses for etofenprox; however,
there is an assessment of the Section 18 food use on rice in Louisiana
(February 8, 2007).  Time-limited tolerances for residues of etofenprox
have been established on rice grain and straw.  The Section 18
assessment indicates no risks of concern.

A Section 3 request for use on rice is currently pending and has a PRIA
date of November 2008.

Data depicting the magnitude of the residue in rice are required for the
pending Section 3 food use and have been submitted.  These data will be
reviewed in connection with the new use request.  No new human health
data are required to support the currently registered etofenprox uses.

The Agency anticipates a review of the short-term incidental oral
endpoint and the need for new risk assessments for individual and
aggregate scenarios using the reassessed short-term incidental oral
endpoint.

  

Timeline

EPA has created the following estimated timeline for the completion of
the etofenprox registration review.  

Docket Number:  EPA-HQ-OPP-2007-0804

www.regulations.gov

Registration Review for Etofenprox – Projected Registration Review
Timeline

Activities	Time

Opening the docket

Docket Opened  	2007 – August

Comment Period Closed  	2007 – November

Case Development

Final Work Plan 	2008 – January

Preliminary Risk Assessments and public comment 	2010 – July – Sept.

Close Public Comment Period	2010 – Oct. – Dec.

Registration Review Decision

Proposed Registration Review Decision 	2011 – Jan. – Mar.

Public Comment Period 	2011 – Apr. - June

Final Registration Review Decision and Begin Post-Decision Follow-up
2011

Total (years)	4

Note:  The Agency reserves the option to issue a DCI or require the data
as a condition of registration for the pending Section 3 registration if
the data that are currently in-house and unreviewed are determined to be
inadequate.  If a DCI is issued, additional time to complete
registration review will be necessary.

Summary of Comments and Agency Responses:

  

The etofenprox registration review docket was opened for a 90-day
comment period beginning on August 27, 2007.  During that time, comments
were received from the technical registrant, Mitsui Chemicals America,
Inc., and the FIFRA Endangered Species Task Force (FESTF).

Summary of Comments from Mitsui Chemicals, Inc. 

1.	Comments Regarding the Typical Use Patterns for Yard and Patio Fogger

	Comments:

	The typical sites of application:  The typical use patterns for yard
and patio 	fogger 	are as defined by the label (EPA Reg. 33657-34).

	The duration of spray events:  Although the product can cover 10,000
square 	feet, typically most homeowners will use the product to cover
yard and patio areas 

Docket Number:  EPA-HQ-OPP-2007-0804

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	that are smaller than 10,000 square feet.  In effect, it is a spot
treatment and not an 	area-wide treatment.  

	Information regarding potential for spray drift:  The fogger is an
aerosol, 	providing droplet sizes that can be defined by the ASAE
aerosol reference 	distribution.  As such, aerosols provide very fine
particles which are subject to 

	drift, but also have high evaporation rates, and therefore will not
have a high 	percentage deposition.  Efficacy is based on droplet 
contact with flying insects. It 	is not a product where efficacy is
expected from deposition on leaf surfaces, 	for example. 

 	The maximum application rates:  A 15 ounce can treats 10,000 square
feet and 	contains 0.075 ounces of active ingredient.  Therefore, the
maximum application 	rate is 0.022 pounds of active ingredient per acre.

	The annual frequency of application, date of initial application,
application 	intervals, and maximum number of application per year: 
Depending on 	mosquito pressure, a homeowner would typically use the
product 4 times on a bi-	weekly	cycle and cover a significant portion of
the summer (in northern states).  	Annual frequency of application
ranges from 4 to 6 times per year.  The initial 	

	application dates would vary by latitude; earlier in the southern
states and later in 	northern states.  In southern states (LA, FL)
although some counties may spray 	adulticides year-round, the practical
season is from March through September or 	October.   As stated in the
label (EPA Reg. No. 33657-34), the application 	interval is 14 days and
the maximum number of application per year is six.   

	Response:   The Agency thanks Mitsui Chemical Inc. for providing its
comments 	on the typical use patterns for yard and patio fogger, and
will consider this use 	information as it conducts the registration
review and makes its registration 	review decision.

	

Summary of Comment Regarding the FIFRA Endangered Species Task Force

2.	Comment:  The FIFRA Endangered Species Task Force (FESTF) noted that
EPA 	stated in the Registration Review summary document that etofenprox
does not 	have a complete environmental risk assessment that is in
compliance with 	EPA’s 	Overview Document for Endangered and
Threatened Species Effects 	Determinations.  FESTF requests that EPA
assure that any company that is 	relying upon FESFT data, and is not a
member file a proper offer to pay for data 	compensation.

Docket Number:  EPA-HQ-OPP-2007-0804

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	Response:  The Agency thanks FESTF for its comment, and will consider
this 	information as it conducts the registration review and makes its
registration 	review decision. 

Next Steps:

The Agency will conduct a human health risk assessment and an ecological
risk assessment that includes a complete endangered species assessment.