Document ID: EPA-HQ-OPP-2009-0301-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-16T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

Date: November 16, 2009

PC Code:  109303

	DP Barcode: 365048  

	

MEMORANDUM

Subject:	Registration Review:  Preliminary Problem Formulation for
Ecological Risk, Environmental Fate, Endangered Species, and Drinking
Water Assessment for Esfenvalerate

To:		Molly Clayton, Chemical Risk Manager

		Michael Goodis, Risk Manager

Special Review and Reregistration Division

Office of Pesticide Programs

From:		Nelson Thurman, Senior Fate Scientist

		Katrina White, Ph.D., Biologist (Effects Scientist)

		Environmental Risk Branch 2

		Environmental Fate and Effects Division

		Office of Pesticide Programs

Through:	Tom Bailey, Ph.D. Branch Chief

		Jean Holmes, DVM, MPH

		Environmental Risk Branch 2

		Environmental Fate and Effects Division

		Office of Pesticide Programs

The Environmental Fate and Effects Division (EFED) has completed the
preliminary problem formulation (attached) for the ecological risk,
environmental fate, endangered species, and drinking water assessment to
be conducted as part of the Registration Review of the insecticide
esfenvalerate (PC Code 109303).  Functioning as the first stage of the
risk assessment process for registration review, this problem
formulation provides an overview of what is currently known about the
environmental fate and ecological effects associated with esfenvalerate
and its degradates.  It also describes the preliminary ecological risk
hypothesis and analysis plan for evaluating and characterizing risk to
non-target species in support of the registration of esfenvalerate. 

  SEQ CHAPTER \h \r 1 

				

Problem Formulation for the 

Environmental Fate, Ecological Risk, and Endangered Species Assessments 

in Support of the Registration Review of Esfenvalerate

Esfenvalerate 

CAS Number 66230-04-4 

PC Code 109303

Prepared by:

Katrina White, Ph.D., Biologist (Effects Scientist)

Nelson Thurman, Senior Fate Scientist	U. S. Environmental Protection
Agency

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch II

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460

Reviewed by:

Jean Holmes, DVM, MPH

Tom Bailey, Ph.D. Branch Chief

	

November 16, 2009

Table of Contents

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc246135955"  1.	Purpose	 
PAGEREF _Toc246135955 \h  5  

  HYPERLINK \l "_Toc246135956"  2.	Problem Formulation	  PAGEREF
_Toc246135956 \h  5  

  HYPERLINK \l "_Toc246135957"  2.1.	Nature of Regulatory Action	 
PAGEREF _Toc246135957 \h  5  

  HYPERLINK \l "_Toc246135958"  2.2.	Previous Ecological Risk
Assessments, Drinking Water Assessments, Data Call Ins, and Other
Relevant History	  PAGEREF _Toc246135958 \h  5  

  HYPERLINK \l "_Toc246135959"  2.2.1	Ecological Risk Assessments
Completed Prior to 1990	  PAGEREF _Toc246135959 \h  5  

  HYPERLINK \l "_Toc246135960"  2.2.2	Ecological Risk Assessments
Completed in 1990 - 1995	  PAGEREF _Toc246135960 \h  6  

  HYPERLINK \l "_Toc246135961"  2.2.3	Risk Assessments Completed in 1999
  PAGEREF _Toc246135961 \h  8  

  HYPERLINK \l "_Toc246135962"  2.2.4	1999 Scientific Advisory Panel on
Sediment Toxicity and Fate of Synthetic Pyrethroids	  PAGEREF
_Toc246135962 \h  8  

  HYPERLINK \l "_Toc246135963"  2.2.5	Section 3 Risk Assessment for Use
on Almonds, Cabbage, Cocoa Bean, Peanuts, Walnuts, Brussels Sprouts,
Canola, Pistachios, Bok Choy, Cardoon and Sweet Potatoes	  PAGEREF
_Toc246135963 \h  9  

  HYPERLINK \l "_Toc246135964"  2.2.6	Drinking Water Exposure
Assessments	  PAGEREF _Toc246135964 \h  10  

  HYPERLINK \l "_Toc246135965"  2.2.7	2009 Scientific Advisory Panel on
the Evaluation of the Common Mechanism of Action of Pyrethroid
Pesticides	  PAGEREF _Toc246135965 \h  10  

  HYPERLINK \l "_Toc246135966"  2.2.8	Aquatic Life Criteria	  PAGEREF
_Toc246135966 \h  10  

  HYPERLINK \l "_Toc246135967"  2.2.9	Impaired Water Bodies	  PAGEREF
_Toc246135967 \h  10  

  HYPERLINK \l "_Toc246135968"  2.2.10	Effects Determinations for
Esfenvalerate for the California Red-Legged Frog	  PAGEREF _Toc246135968
\h  11  

  HYPERLINK \l "_Toc246135969"  3.	Mechanism of Action, Type of
Pesticide, Usage, and Environmental Fate	  PAGEREF _Toc246135969 \h  11 

  HYPERLINK \l "_Toc246135970"  3.1.	Mechanism of Action and Type of
Pesticide	  PAGEREF _Toc246135970 \h  11  

  HYPERLINK \l "_Toc246135971"  3.2.	Overview of Pesticide Usage	 
PAGEREF _Toc246135971 \h  12  

  HYPERLINK \l "_Toc246135972"  3.3.	Environmental Fate and Transport	 
PAGEREF _Toc246135972 \h  16  

  HYPERLINK \l "_Toc246135973"  3.3.1	Degradation	  PAGEREF
_Toc246135973 \h  18  

  HYPERLINK \l "_Toc246135974"  3.3.2	Transport	  PAGEREF _Toc246135974
\h  21  

  HYPERLINK \l "_Toc246135975"  3.3.3	Field Studies	  PAGEREF
_Toc246135975 \h  21  

  HYPERLINK \l "_Toc246135976"  3.3.4	Water Monitoring Data	  PAGEREF
_Toc246135976 \h  22  

  HYPERLINK \l "_Toc246135977"  3.3.5	Bioaccumulation	  PAGEREF
_Toc246135977 \h  23  

  HYPERLINK \l "_Toc246135978"  4.	Receptors	  PAGEREF _Toc246135978 \h 
23  

  HYPERLINK \l "_Toc246135979"  4.1.	Effects to Aquatic Organisms	 
PAGEREF _Toc246135979 \h  24  

  HYPERLINK \l "_Toc246135980"  4.2.	Effects to Terrestrial Organisms	 
PAGEREF _Toc246135980 \h  29  

  HYPERLINK \l "_Toc246135981"  4.3.	Incident Database Review	  PAGEREF
_Toc246135981 \h  32  

  HYPERLINK \l "_Toc246135982"  4.4.	Ecosystems Potentially at Risk	 
PAGEREF _Toc246135982 \h  38  

  HYPERLINK \l "_Toc246135983"  5.	Assessment Endpoints	  PAGEREF
_Toc246135983 \h  38  

  HYPERLINK \l "_Toc246135984"  6.	Conceptual Model	  PAGEREF
_Toc246135984 \h  38  

  HYPERLINK \l "_Toc246135985"  6.1.	Risk Hypothesis	  PAGEREF
_Toc246135985 \h  39  

  HYPERLINK \l "_Toc246135986"  6.2.	Conceptual Diagram	  PAGEREF
_Toc246135986 \h  39  

  HYPERLINK \l "_Toc246135987"  7.	Analysis Plan	  PAGEREF _Toc246135987
\h  41  

  HYPERLINK \l "_Toc246135988"  7.1.	Stressors of Concern	  PAGEREF
_Toc246135988 \h  42  

  HYPERLINK \l "_Toc246135989"  7.2.	Measures of Exposure	  PAGEREF
_Toc246135989 \h  43  

  HYPERLINK \l "_Toc246135990"  7.2.1	Aquatic Organisms	  PAGEREF
_Toc246135990 \h  44  

  HYPERLINK \l "_Toc246135991"  7.2.2	Terrestrial Organisms	  PAGEREF
_Toc246135991 \h  44  

  HYPERLINK \l "_Toc246135992"  7.3.	Measures of Effect	  PAGEREF
_Toc246135992 \h  46  

  HYPERLINK \l "_Toc246135993"  7.4.	Integration of Exposure and Effects
  PAGEREF _Toc246135993 \h  47  

  HYPERLINK \l "_Toc246135994"  7.5.	Deterministic and Probabilistic
Assessment Methods	  PAGEREF _Toc246135994 \h  47  

  HYPERLINK \l "_Toc246135995"  7.6.	Endangered Species Assessments	 
PAGEREF _Toc246135995 \h  47  

  HYPERLINK \l "_Toc246135996"  7.7.	Drinking Water Assessment	  PAGEREF
_Toc246135996 \h  48  

  HYPERLINK \l "_Toc246135997"  7.8.	Preliminary Identification of Data
Gaps	  PAGEREF _Toc246135997 \h  48  

  HYPERLINK \l "_Toc246135998"  7.8.1	Fate	  PAGEREF _Toc246135998 \h 
48  

  HYPERLINK \l "_Toc246135999"  7.8.2	Effects	  PAGEREF _Toc246135999 \h
 49  

  HYPERLINK \l "_Toc246136000"  7.9.	Other Information Needed for the
Risk Assessment	  PAGEREF _Toc246136000 \h  58  

  HYPERLINK \l "_Toc246136001"  8.	References	  PAGEREF _Toc246136001 \h
 58  

  HYPERLINK \l "_Toc246136002"  8.1.	Literature Cited	  PAGEREF
_Toc246136002 \h  58  

  HYPERLINK \l "_Toc246136003"  8.2.	Submitted Fate Studies	  PAGEREF
_Toc246136003 \h  64  

  HYPERLINK \l "_Toc246136004"  8.3.	Submitted Effects Studies for
Fenvalarate	  PAGEREF _Toc246136004 \h  66  

  HYPERLINK \l "_Toc246136005"  8.4.	Submitted Effects Studies for
Esfenvalerate	  PAGEREF _Toc246136005 \h  72  

 

List of Tables

  TOC \h \z \c "Table"    HYPERLINK \l "_Toc246136006"  Table 3-1. 
Labeled Agricultural Uses1,2	  PAGEREF _Toc246136006 \h  12  

  HYPERLINK \l "_Toc246136007"  Table 3-2.  Labeled Non-agricultural
Uses Assessed in this Document.1,2	  PAGEREF _Toc246136007 \h  15  

  HYPERLINK \l "_Toc246136008"  Table 3-3.  Labeled Non- agricultural
Uses Qualitatively Assessed in this Document	  PAGEREF _Toc246136008 \h 
16  

  HYPERLINK \l "_Toc246136009"  Table 3-4.  Summary of Physico-Chemical
Properties of Esfenvalerate.	  PAGEREF _Toc246136009 \h  18  

  HYPERLINK \l "_Toc246136010"  Table 3-5.  Summary of Esfenvalerate
Environmental Fate Properties.	  PAGEREF _Toc246136010 \h  19  

  HYPERLINK \l "_Toc246136011"  Table 4-1.  Summary of Sensitive
Endpoints for Aquatic Organisms Under Consideration for Use in the Risk
Assessment for Esfenvaleratea	  PAGEREF _Toc246136011 \h  26  

  HYPERLINK \l "_Toc246136012"  Table 4-2.  Summary of Sensitive
Toxicity Endpoints for Terrestrial Organisms Under Consideration for Use
in Risk Assessment*	  PAGEREF _Toc246136012 \h  31  

  HYPERLINK \l "_Toc246136013"  Table 4-3.  Wildlife Incidents from the
EIIS Database Associated with Esfenvalerate	  PAGEREF _Toc246136013 \h 
36  

  HYPERLINK \l "_Toc246136014"  Table 7-1.  Summary of Environmental
Fate Studies	  PAGEREF _Toc246136014 \h  49  

  HYPERLINK \l "_Toc246136015"  Table 7-2.  Available Ecological Effects
Data for Terrestrial Animals Exposed to Esfenvalerat and Fenvalerate	 
PAGEREF _Toc246136015 \h  51  

  HYPERLINK \l "_Toc246136016"  Table 7-3.  Available Ecological Effects
Data for Aquatic Animals Exposed to Esfenvalerate or Fenvalerate	 
PAGEREF _Toc246136016 \h  52  

 

List of Figures

  TOC \h \z \c "Figure"    HYPERLINK \l "_Toc246136017"  Figure 3-1.
Chemical Structures of Esfenvalerate and Related Compounds	  PAGEREF
_Toc246136017 \h  17  

  HYPERLINK \l "_Toc246136018"  Figure 6-1.  Conceptual Model Depicting
Exposure Pathways and Potential Risks to Aquatic Organisms from the Use
of Esfenvalerate.  Dashed lines indicate routes of exposure considered
of lower or negligible importance for esfenvalerate.	  PAGEREF
_Toc246136018 \h  40  

  HYPERLINK \l "_Toc246136019"  Figure 6-2.  Conceptual Model Depicting
Exposure Pathways and Potential Risks to Terrestrial Organisms from the
Use of Esfenvalerate.  Dashed lines indicate routes of exposure
considered of lower importance for esfenvalerate.	  PAGEREF
_Toc246136019 \h  41  

 

Appendices

  TOC \h \z \c "Appendix"    HYPERLINK \l "_Toc246136020"  Appendix A: 
Data Call In Tables	  PAGEREF _Toc246136020 \h  75  

  HYPERLINK \l "_Toc246136021"  Appendix B:  Summary of Toxicity Data	 
PAGEREF _Toc246136021 \h  83  

  HYPERLINK \l "_Toc246136022"  Appendix C:  Summary of products with
multiple active ingredients	  PAGEREF _Toc246136022 \h  98  

  HYPERLINK \l "_Toc246136023"  Appendix D.  ECOSAR (version 1.0)
Results for 4-chloro-alpha-(1-methylethyl)-benzeneacetic acid (CPIA)	 
PAGEREF _Toc246136023 \h  108  

 

Purpose

The purpose of this problem formulation is to provide an understanding
of what is known about the environmental fate and ecological effects of
the registered uses of esfenvalerate.  Esfenvalerate is a broad spectrum
pyrethroid insecticide.  This document will provide a plan for analyzing
data relevant to esfenvalerate and for conducting environmental fate,
ecological risk, endangered species, and drinking water assessments for
its registered uses.  Additionally, this problem formulation is intended
to identify data gaps, uncertainties, and potential assumptions used to
address those uncertainties relative to characterizing the ecological
risk associated with the registered uses of esfenvalerate.  

Problem Formulation

Nature of Regulatory Action

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
all pesticides distributed or sold in the United States generally must
be registered by the United States Environmental Protection Agency
(USEPA).  To determine whether a pesticide can be registered, the USEPA
evaluates its safety to non-target species based on a wide range of
environmental and health effects studies.   In 1996, FIFRA was amended
by the Food Quality Protection Act (FQPA), and EPA was mandated to
implement a new program for the periodic review of pesticides, i.e.,
registration review (  HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/" 
http://www.epa.gov/oppsrrd1/registration_review/ ).  The registration
review program is intended to ensure that, as the ability to assess risk
evolves and as policies and practices change, all registered pesticides
continue to meet the statutory standard of no unreasonable adverse
effects to human health and the environment. Changes in science, public
policy, and pesticide use practices will occur over time. Through the
new registration review program, the Agency periodically reevaluates
pesticides to make sure that as change occurs, products in the
marketplace can be used safely. 

As part of the implementation of the new Registration Review program
pursuant to Section 3(g) of FIFRA, the Agency is beginning its
evaluation of esfenvalerate to determine whether it continues to meet
the FIFRA standard for registration. This problem formulation for the
environmental fate and ecological risk assessment chapter in support of
the registration review will be posted in the initial docket opening the
public phase of the review process.

Previous Ecological Risk Assessments, Drinking Water Assessments, Data
Call Ins, and Other Relevant History

Ecological Risk Assessments Completed Prior to 1990

In 1986, a request was made to register esfenvalerate (the SS-isomer in
the racemic mixture of fenvalerate) based on the data submitted on the
racemic mixture   ADDIN EN.CITE
<EndNote><Cite><Author>RexRode</Author><Year>1986</Year><RecNum>43</RecN
um><DisplayText>(Rexrode,
1986)</DisplayText><record><rec-number>43</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">43</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">402</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Rexrode,
Miachel</author></authors><tertiary-authors><author>George
LaRocca</author></tertiary-authors></contributors><titles><title>Substit
ution of SS isomer (ASANA) for the racemic mixture
(Pydrin)</title><tertiary-title>Ecological Effect Branch.  Hazard
Evaluation Division.  Office of Pesticide
Progams</tertiary-title></titles><edition>United States Environmental
Protection Agency</edition><dates><year>1986</year><pub-dates><date>May
6,
1986</date></pub-dates></dates><urls></urls></record></Cite></EndNote>
(Rexrode, 1986) .  A review of acute fish toxicity data for fenvalerate
(LC50 = 0.70 µg/L) and esfenvalerate (LC50 = 0.26 µg/L) indicated that
they would have similar toxicity to fish and therefore, data on
fenvalerate could be used in support of the registration of the
SS-isomer.  An aquatic field study was still required for fenvalerate.

In 1987, the Environmental Fate and Effects Division (EFED) reviewed the
emergency use of fenvalerate on cranberries in Washington   ADDIN
EN.CITE
<EndNote><Cite><Author>Vaughan</Author><Year>1987</Year><RecNum>44</RecN
um><DisplayText>(Vaughan<style face="italic"> et al.</style>,
1987)</DisplayText><record><rec-number>44</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">44</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">403</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Vaughan, Allen
W.</author><author>Cook, Norman J.</author><author>Slimak, Michael
W.</author></authors><tertiary-authors><author>Stubbs,
D.</author></tertiary-authors></contributors><titles><title>Esfenvalerat
e:  Proposed Section 18 for Use on
Cranberries</title><tertiary-title>Ecological Effects Branch.  Hazard
Evaluation Division.  Office of Pesticide
Programs</tertiary-title></titles><edition>United States Environmental
Protection
Agency</edition><keywords><keyword>Esfenvalerate</keyword></keywords><da
tes><year>1987</year><pub-dates><date>June 29,
1987</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Vaughan et
al., 1987) .  The ecological risk assessment found no risk to federally
listed endangered or threatened species from the proposed use and
concluded that, “this use will not present a significant increase in
exposure or hazard to nontarget organisms in general.”  

In 1988, a request was made for an emergency exemption for the use of
esfenvalerate on leafy vegetables (kale, kohlrabi, and mustard greens)
in Texas for control of cabbage loopers   ADDIN EN.CITE
<EndNote><Cite><Author>Johnson</Author><Year>1988</Year><RecNum>109</Rec
Num><DisplayText>(Johnson<style face="italic"> et al.</style>,
1988)</DisplayText><record><rec-number>109</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">109</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">584</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Johnson,
David</author><author>Craven, Harry</author><author>Akerman,
James</author></authors></contributors><titles><title>Ecological Effects
Branch Review of the Section 18 (Texas) Emergency Exemption for the Use
of Esfenvalerate on Leafy Vegetables</title><secondary-title>December
12, 1988</secondary-title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects Division.  Office of Pesticide Programs. 
United States Environmental Protection
Agency</tertiary-title></titles><keywords><keyword>Esfenvalerate</keywor
d></keywords><dates><year>1988</year><pub-dates><date>December 7,
1988</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Johnson et
al., 1988) .  The ecological risk assessment for this use found that a
single application would exceed the acute risk criteria established from
toxicity data on fenvalerate for fish and aquatic invertebrates. 
Additionally, multiple applications could result in chronic risks to
aquatic organisms.

In 1989, a request was made to allow use of esfenvalerate on the uses
already approved for fenvalerate and to allow use on berries, okra, and
turnips   ADDIN EN.CITE
<EndNote><Cite><Author>Rexrode</Author><Year>1989</Year><RecNum>45</RecN
um><DisplayText>(Rexrode, Urban, and  Cook,
1989)</DisplayText><record><rec-number>45</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">45</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">404</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Rexrode,
Miachel</author><author>Urban, Douglas</author><author>Cook, Norman
J.</author></authors><tertiary-authors><author>George
LaRocca</author></tertiary-authors></contributors><titles><title>Propose
d Section 3 Registration of Various Uses (Some of which are on sister
Pydrin label).  Completely new uses are:  cranberries, blueberries,
related bushberries, okra (Florida only), and
turnips</title><tertiary-title>Ecological Effects Branch.  Environmental
Fate and Effects Division.  Office of Pesticide
Programs</tertiary-title></titles><edition>United States Environmental
Protection
Agency</edition><keywords><keyword>Esfenvalerate</keyword></keywords><da
tes><year>1989</year><pub-dates><date>January 27,
1989</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rexrode,
Urban, and  Cook, 1989) .  EFED concluded that use of esfenvalerate may
result in environmental exposures that are one to two orders of
magnitude greater than published aquatic toxicity levels and that any
expansion of the use of the product could result in increased risk to
aquatic organisms.  EFED could not complete the aquatic risk assessment
until a mesocosm study was completed and evaluated.

In 1989 emergency exemptions (Section 18) were requested by the states
of Montana, North Dakota, Kansas, and Minnesota for use of esfenvalerate
(ASANA XL 0.66 EC) for the control of pests in wheat, barley, small
grains, and conservation reserves   ADDIN EN.CITE   ADDIN EN.CITE.DATA  
(Rexrode, Urban, et al., 1989a, 1989b, 1989c, 1989d) .  The EFED
concluded that expected residues exceeded acute and chronic toxicity
values for fish and aquatic invertebrates in prairie potholes, rivers,
lakes, and wetlands adjacent to sprayed fields and would sometimes
result in risk to birds.  EFED recommended that the State Department of
Agriculture be contacted prior to use of esfenvalerate in counties with
endangered species.

Ecological Risk Assessments Completed in 1990 - 1995

In 1990, environmental fate reviews were completed on the registration
of esfenvalerate on grass, grass hay, alfalfa, celery, Brussels sprouts,
and lettuce   ADDIN EN.CITE   ADDIN EN.CITE.DATA   (Nelson, 1990;
Regelman, 1990a, 1990b) .  The registrant requested that the data on the
racemic mixture, fenvalerate (e.g., 25% each isomer), be used to support
the registration of the SS-isomer   ADDIN EN.CITE
<EndNote><Cite><Author>Regelman</Author><Year>1990</Year><RecNum>6</RecN
um><DisplayText>(Regelman,
1990a)</DisplayText><record><rec-number>6</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">6</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">366</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Regelman,
Emil</author></authors></contributors><titles><title>EFGWB Review of
Lable and Tolerance Petition Amendment for &apos;Grass and Grass
Hay&apos;</title><secondary-title>April 6,
1990</secondary-title><tertiary-title>Environmental Fate and Effects
Division.  Office of Pesticide Programs. United States Environmental
Protection
Agency.</tertiary-title></titles><dates><year>1990</year></dates><urls><
/urls></record></Cite></EndNote> (Regelman, 1990a) .  EFED concluded
that the submissions would result in a reduction in the application rate
of the SS-isomer and thus would result in less environmental effects
than those already registered for the racemic mixture.  Additionally,
data on fenvalerate were used to support the registrations of
esfenvalerate.  A bioconcentration study in fish, hydrolysis study, and
field dissipation study were outstanding data requirements at the time
of the reviews.  

In Section 18 reviews for the use of esfenvalerate on wheat, small
grains, non-cropland, berries, and conservation reserve areas in several
states including Kansas, Minnesota, North Dakota, and Oklahoma.  EFED
concluded that all but the cranberry uses would result in risk to
aquatic fish and invertebrates and indirect risk to birds due to
reduction in aquatic organisms   ADDIN EN.CITE   ADDIN EN.CITE.DATA  
(Rexrode et al., 1990d, 1990e, 1990f, 1990h) .  EFED recommended that
the United States Fish and Wildlife Service (USFWS) regional office be
contacted prior to using esfenvalerate in counties with listed or
endangered species.  The same conclusions were drawn for the request for
Section 3 registrations of esfenvalerate on berries, turnips, okra
(Florida only), rangeland, pastures, sorghum, and ornamentals   ADDIN
EN.CITE   ADDIN EN.CITE.DATA   (Rexrode et al., 1990a, 1990b, 1990c) . 
The request for use on sorghum was denied pending the submission of the
mesocosm study, which remained an outstanding data requirement   ADDIN
EN.CITE
<EndNote><Cite><Author>LaRocca</Author><Year>1990</Year><RecNum>59</RecN
um><DisplayText>(LaRocca,
1990)</DisplayText><record><rec-number>59</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">59</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">417</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>LaRocca,
G.</author></authors><tertiary-authors><author>Ackerson, Robert
C.</author></tertiary-authors></contributors><titles><title>Label
Amendment - Add Use on
Sorghum</title><tertiary-title>Insecticide-Rodenticide Branch. 
Registration Division.  Office of Pesticide
Programs</tertiary-title></titles><edition>United States Environmental
Protection Agency</edition><dates><year>1990</year><pub-dates><date>June
14,
1990</date></pub-dates></dates><urls></urls></record></Cite></EndNote>
(LaRocca, 1990) .

A Section 18 request for use of esfenvalerate in Washington on
cranberries and leafy greens in Texas was determined to be of little
risk due to the small area that would be treated in the request   ADDIN
EN.CITE   ADDIN EN.CITE.DATA   (Rexrode et al., 1992a; Rexrode et al.,
1990g) .  Several other Section 18 registration requests were made
between 1991 and 1995 including use on prairie wetlands in Minnesota,
sorghum and leafy greens in Texas, cranberries in Washington, and
sugarbeets in California   ADDIN EN.CITE   ADDIN EN.CITE.DATA  
(Akerman, 1991; Lamb et al., 1993; Rexrode et al., 1993; Rexrode et al.,
1992b; Rexrode et al., 1992c; Rexrode et al., 1991; Urban, 1992; Vaughan
et al., 1994) .  Some of the use requests were approved with
restrictions such as buffer zones between the use site and water bodies
or endangered species habitat; risk assessments for other requests could
not be completed until the mesocosm study was completed.

A mesocosm study was submitted and reviewed in 1993   ADDIN EN.CITE
<EndNote><Cite><Author>Maciorowski</Author><Year>1993</Year><RecNum>99</
RecNum><DisplayText>(Maciorowski,
1993)</DisplayText><record><rec-number>99</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">99</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">574</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Maciorowski, Anthony
F.</author></authors><tertiary-authors><author>LaRocca,
G.</author></tertiary-authors></contributors><titles><title>Hazard
Assessment of Esfenvalerate (ASANA)
Mesocosm</title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects Division.  Office of Pesticide
Programs</tertiary-title></titles><edition>United States Environmental
Protection
Agency</edition><keywords><keyword>Esfenvalerate</keyword></keywords><da
tes><year>1993</year><pub-dates><date>February 1,
1993</date></pub-dates></dates><label>Memo</label><urls></urls></record>
</Cite></EndNote> (Maciorowski, 1993) .  The results of the mesocosm
study indicated that, “esfenvalerate use will have a significant
influence on the populations of certain aquatic zooplankton and
macroinvertebrates. The resulting decline in these populations, at times
that coincide with fish reproduction (bluegill), will represent a
decrease in a significant food base which will affect fish larval growth
and possibly year-class strength.”  The comparative applicability of
this study to aquatic environments outside of the study area was
questioned because changes in aquatic chemistry during the study
(increased alkalinity and rising pH from supplemental fertilization)
appeared to affect esfenvalerate exposure potential and may have masked
higher toxicity concerns for this synthetic pyrethroid.

Early in 1995, EFED proposed mitigation measures for the use of
esfenvalerate on cotton and recommended that the mitigation measures
apply to all 50 uses for esfenvalerate   ADDIN EN.CITE
<EndNote><Cite><Author>Maciorowski</Author><Year>1995</Year><RecNum>104<
/RecNum><DisplayText>(Maciorowski,
1995)</DisplayText><record><rec-number>104</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">104</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">579</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Maciorowski, Anthony
F.</author></authors><tertiary-authors><author>Lewis,
Susan</author></tertiary-authors><subsidiary-authors><author>Maciorowski
, Anthony
F.</author></subsidiary-authors></contributors><titles><title>Pyrethroid
Mitigation</title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects
Division</tertiary-title></titles><edition>United States Environmental
Protection
Agency</edition><keywords><keyword>Esfenvalerate</keyword></keywords><da
tes><year>1995</year><pub-dates><date>March 9,
1995</date></pub-dates></dates><label>Memo</label><urls></urls></record>
</Cite></EndNote> (Maciorowski, 1995) .  Based on new data available
from the Spray Drift Task Force, EFED determined that the mitigation
measures should be revisited with external peer review.  In the interim,
the mitigation measures would apply to all esfenvalerate uses pending
review by the Office of Pesticide Programs (OPP) and by an external peer
review panel (see Section 2.2.5). 

In 1995, several environmental risk assessments were completed for
84:8.4 SS:all isomer mixture.  Section 3 uses assessed include lettuce  
ADDIN EN.CITE
<EndNote><Cite><Author>Rabert</Author><Year>1995</Year><RecNum>105</RecN
um><DisplayText>(Rabert<style face="italic"> et al.</style>,
1995e)</DisplayText><record><rec-number>105</rec-number><foreign-keys><k
ey app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">105</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">580</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Rabert,
William</author><author>Craven, Harry</author><author>Maciorowski,
Anthony F.</author></authors></contributors><titles><title>EEB Review of
Esfenvalerate Use on Head Lettuce</title><secondary-title>October 13,
1995</secondary-title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects Division.  Office of Pesticide Programs. 
United States Environmental Protection
Agency</tertiary-title></titles><keywords><keyword>Esfenvalerate</keywor
d></keywords><dates><year>1995</year><pub-dates><date>October 13,
1995</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rabert et
al., 1995e) , grain sorghum   ADDIN EN.CITE
<EndNote><Cite><Author>Rabert</Author><Year>1995</Year><RecNum>110</RecN
um><DisplayText>(Rabert<style face="italic"> et al.</style>,
1995a)</DisplayText><record><rec-number>110</rec-number><foreign-keys><k
ey app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">110</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">585</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Rabert,
William</author><author>Craven, Harry</author><author>Maciorowski,
Anthony F.</author></authors></contributors><titles><title>Ecological
Effects Branch Review of Esfenvalerate Use on Grain
Sorghum</title><secondary-title>September 15,
1955</secondary-title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects Division.  Office of Pesticide Programs. 
United States Environmental Protection
Agency</tertiary-title></titles><keywords><keyword>Esfenvalerate</keywor
d></keywords><dates><year>1995</year><pub-dates><date>September 15,
1995</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rabert et
al., 1995a) , sugar beets   ADDIN EN.CITE
<EndNote><Cite><Author>Rabert</Author><Year>1995</Year><RecNum>108</RecN
um><DisplayText>(Rabert<style face="italic"> et al.</style>,
1995b)</DisplayText><record><rec-number>108</rec-number><foreign-keys><k
ey app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">108</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">583</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Rabert,
William</author><author>Craven, Harry</author><author>Maciorowski,
Anthony F.</author></authors></contributors><titles><title>Ecological
Effects Branch Review of Esfenvalerate Use on Sugar
Beets</title><secondary-title>November 8,
1995</secondary-title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects Division.  Office of Pesticide Programs. 
United States Environmental Protection
Agency</tertiary-title></titles><keywords><keyword>Esfenvalerate</keywor
d></keywords><dates><year>1995</year><pub-dates><date>November 8,
1995</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rabert et
al., 1995b) , Brussels sprouts   ADDIN EN.CITE
<EndNote><Cite><Author>Rabert</Author><Year>1995</Year><RecNum>107</RecN
um><DisplayText>(Rabert<style face="italic"> et al.</style>,
1995c)</DisplayText><record><rec-number>107</rec-number><foreign-keys><k
ey app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">107</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">582</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Rabert,
William</author><author>Craven, Harry</author><author>Maciorowski,
Anthony F.</author></authors></contributors><titles><title>Ecological
Effects Branch Review on the Section 3 Use of Esfenvalerate on Brussel
Sprouts</title><secondary-title>October 24,
1995</secondary-title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects Division.  Office of Pesticide Programs. 
United States Environmental Protection
Agency</tertiary-title></titles><keywords><keyword>Esfenvalerate</keywor
d></keywords><dates><year>1995</year><pub-dates><date>October 24,
1995</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rabert et
al., 1995c) , and celery   ADDIN EN.CITE
<EndNote><Cite><Author>Rabert</Author><Year>1995</Year><RecNum>106</RecN
um><DisplayText>(Rabert<style face="italic"> et al.</style>,
1995d)</DisplayText><record><rec-number>106</rec-number><foreign-keys><k
ey app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">106</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">581</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Rabert,
William</author><author>Craven, Harry</author><author>Maciorowski,
Anthony F.</author></authors></contributors><titles><title>Ecological
Effects Branch Section 3 Review of Use of Esfenvalerate on
Celery</title><secondary-title>October 20,
1995</secondary-title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects Division.  Office of Pesticide Programs. 
United States Environmental Protection
Agency</tertiary-title></titles><keywords><keyword>Esfenvalerate</keywor
d></keywords><dates><year>1995</year><pub-dates><date>October 20,
1995</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rabert et
al., 1995d) .

The following risks were identified even with the interim risk
mitigation measures in place:

acute and chronic risk to small mammals, 

chronic risk to birds, 

acute risk to bees and non-target insects. and

acute and chronic risk to freshwater fish and invertebrates.

Risk could not be assessed for estuarine species or terrestrial or
aquatic plants.

The following data gaps were identified in 1995:

quail and mallard reproduction studies,

acute flow-through, measured, for fathead minnow and bluegill for the
formulation,

freshwater fish full life-cycle test, fathead minnow preferred,

two daphnid acute studies, with diluter and static,

estuarine/marine fish acute study (72-3a),

estuarine early life-stage study (72-4a),

acute oyster study (72-3b),

acute mysid shrimp (72-3c), and 

estuarine life-cycle test for mysid shrimp (72-4b).

Additionally, the following tests were identified as needed in the
future:

terrestrial plants tier I seed germination, seedling emergence, and
vegetative vigor, and

aquatic plant toxicity.

Risk Assessments Completed in 1999

In 1999, an ecological risk assessment in support of a Section 24c
California registration for use of esfenvalerate on forest sites to
control grasshoppers and crickets identified the following risks   ADDIN
EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) :

chronic risk to birds presumed,

acute and chronic risk to mammals, and

acute and chronic risk to freshwater and estuarine/marine fish and
invertebrates.

Risk to terrestrial invertebrates was not evaluated in the 1999
assessment.

Data gaps included:

avian reproduction data (71-4),

freshwater fish full life-cycle study (72-5),

estuarine/marine fish early life-stage study (72-4a),

estuarine/marine invertebrate life-cycle study (72-4b), and

estuarine/marine fish full life-cycle study (72-5).

1999 Scientific Advisory Panel on Sediment Toxicity and Fate of
Synthetic Pyrethroids

A Scientific Advisory Panel (SAP) in 1999 examined the sediment toxicity
and fate of synthetic pyrethroids.  In response to a question regarding
whether sediment toxicity data on one pyrethroid (cypermethrin) could be
used to predict sediment toxicity to all pyrethroids, the panel
generally supported the method of using data from a few pyrethroids to
extrapolate information on toxicity to other pyrethroids.  The panel
recommended testing cypermethrin, “bifenthrin (relatively non-toxic to
freshwater aquatic organisms, very insoluble in water, large
bioconcentration factor) and possibly trefluthrin (highly toxic to
freshwater aquatic organisms, stable in water, intermediate solubility
in water to cypermethrin and bifenthrin)”   ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>1999</Year><RecNum>42</RecNum
><DisplayText>(USEPA,
1999)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">42</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">401</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>USEPA,</author></a
uthors><secondary-authors><author>SAP Report No.
99-03A</author></secondary-authors></contributors><titles><title>FIFRA
Scientific Advisory Panel Meeting, February 23, 1999 held ad the Holiday
Inn Hotel, Arlington, Virginia.</title><secondary-title>March 25,
1999</secondary-title><tertiary-title>Office of Pesticide
Programs</tertiary-title></titles><keywords><keyword>Pyrethroid,
esfenvalerate</keyword></keywords><dates><year>1999</year><pub-dates><da
te>March 25, 1999</date></pub-dates></dates><label>Scientific Advisory
Panel</label><urls><related-urls><url>http://www.epa.gov/scipoly/sap/mee
tings/1999/022399_mtg.htm#materials</url></related-urls></urls><access-d
ate>June 26, 2009</access-date></record></Cite></EndNote> (USEPA, 1999)
. The SAP also stated that a sediment:water ratio of 1 to 25 was
acceptable for sediment toxicity tests.

The SAP commented on the use of Kd or KOC to estimate concentrations of
synthetic pyrethroids in sediments, recommending that the Agency
reconsider KOC as a measure of the binding potential of synthetic
pyrethroids to sediment and soil because the use of Kd alone limits
extrapolation to experimental conditions while KOC “allows one to
estimate partitioning across a wide variety of soil/sediment types”  
ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>1999</Year><RecNum>42</RecNum
><DisplayText>(USEPA,
1999)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">42</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">401</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>USEPA,</author></a
uthors><secondary-authors><author>SAP Report No.
99-03A</author></secondary-authors></contributors><titles><title>FIFRA
Scientific Advisory Panel Meeting, February 23, 1999 held ad the Holiday
Inn Hotel, Arlington, Virginia.</title><secondary-title>March 25,
1999</secondary-title><tertiary-title>Office of Pesticide
Programs</tertiary-title></titles><keywords><keyword>Pyrethroid,
esfenvalerate</keyword></keywords><dates><year>1999</year><pub-dates><da
te>March 25, 1999</date></pub-dates></dates><label>Scientific Advisory
Panel</label><urls><related-urls><url>http://www.epa.gov/scipoly/sap/mee
tings/1999/022399_mtg.htm#materials</url></related-urls></urls><access-d
ate>June 26, 2009</access-date></record></Cite></EndNote> (USEPA, 1999)
.  The Panel expressed concern that standard methods used to measure
sorption may not be applicable to highly hydrophobic compounds due to
high solids to water ratio, consideration of the character of the
organic matter, presence of dissolved organic carbon, use of
non-representative soils and sediments as sorbents, and improper methods
used to measure organic carbon.

While the biota-sediment-accumulation-factor is a widely accepted method
of assessment of bioaccumulation in sediments, the Panel indicated that
the bioconcentration data for Daphnia and Hyalella should be sufficient
to predict bioconcentration of pyrethroids.  Finally, the Panel
indicated that use of a solid phase microextraction (SMPE) method to
determine the dissolved concentration in water could be used to account
for sorption of pyrethroids to organic carbon and colloids present in
the water column in the measurement of bioconcentration factors.

In 2003 and in response to the comments from the SAP on pyrethroids, 
EFED requested the following studies on esfenvalerate   ADDIN EN.CITE
<EndNote><Cite><Author>Rexrode</Author><Year>2003</Year><RecNum>5</RecNu
m><DisplayText>(Rexrode and Melendez,
2003)</DisplayText><record><rec-number>5</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">5</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">365</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Rexrode,
Miachel</author><author>Melendez, Jose
Luis</author></authors><secondary-authors><author>United States
Environmental Protection
Agency</author></secondary-authors><tertiary-authors><author>Johnson,
M.</author><author>LaRocca,
G.</author></tertiary-authors></contributors><titles><title>EFED&apos;s
rationale for choosing Cypermethrin,, Esfenvalerate, Bifenthrin, and
Cyfluthrin for sediment testing as discussed with the Pyrethroid Working
Group (PWG)</title><tertiary-title>Environmental Fate and Effects
Division.  Office of Pesticide Programs.  United States Environmental
Protection
Agency</tertiary-title></titles><keywords><keyword>Pyrethroid,
esfenvalerate</keyword></keywords><dates><year>2003</year><pub-dates><da
te>December 23, 2003</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rexrode and
Melendez, 2003) .

850.1735: Acute Sediment (freshwater)

- Test organism: Hyalella azteca and Chironomus tentans

- Duration: 10 days, endpoint is survival.

EPA/600/R01/020: Chronic Estuarine/Marine Sediment Testing

- 28 day test on Leptocheirus plumulosus,

- Percentage of neonates that survive as adults.

- Growth rate.

- Reproduction (#eggs/female, etc.).

- Behavior.

Section 3 Risk Assessment for Use on Almonds, Cabbage, Cocoa Bean,
Peanuts, Walnuts, Brussels Sprouts, Canola, Pistachios, Bok Choy,
Cardoon and Sweet Potatoes

A 2003 Section 3 environmental risk assessment for the use of
esfenvalerate on almonds, cabbage, cocoa bean, peanuts, walnuts,
Brussels sprouts, canola, pistachios, bok choy, cardoon, and sweet
potatoes concluded   ADDIN EN.CITE
<EndNote><Cite><Author>Felthousen</Author><Year>2003</Year><RecNum>4</Re
cNum><DisplayText>(Felthousen and Abdel-Saheb,
2003)</DisplayText><record><rec-number>4</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">4</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">364</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Felthousen, R.
W.</author><author>Abdel-Saheb,
I.</author></authors><secondary-authors><author>D257890, D257987,
D259704,
D257273</author></secondary-authors><tertiary-authors><author>United
States Environmental Protection
Agency</author></tertiary-authors></contributors><titles><title>EFED
Risk Assessment for Section 3 Registration for use of Esfenvalerate on
Almonds,Cabbage, Cocoa Bean, Peanuts, Walnuts, Brussel sprouts, Canola,
Pistachios, Bok Choy,Cardoon and Sweet
Potatoes</title><secondary-title>June 16,
2003</secondary-title><tertiary-title>Environmental Fate and Effects
Division.  Office of Pesticide
Programs</tertiary-title></titles><keywords><keyword>Esfenvalerate</keyw
ord></keywords><dates><year>2003</year></dates><pub-location>Washington,
D.C.</pub-location><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Felthousen
and Abdel-Saheb, 2003) : 

“Because the proposed Section 3 represents minor use patterns, which
amounts to relatively small increase in the number of potentially
treated acres, and because the application rates and number of
applications, for all of the proposed new uses are equivalent to those
that are currently registered, for which comprehensive risk assessments
have already been completed, the EFED believes there is very little
incremental risk from the proposed new uses to non-target fish and
wildlife species.”

Drinking Water Exposure Assessments

In support of various registration/new use actions that occurred after
the passage of the Food Quality Protection Act in 1996, EFED conducted
Tier 2 surface water and Tier 1 ground water screening assessments for
estimated concentrations in drinking water sources from esfenvalerate
uses on cotton and tree nurseries in 2002.  In a 2006 assessment for
proposed new uses of esfenvalerate on oil seed crops, EFED concluded
that, with lower application rates (0.1 lb ai/A va 1.5 lb ai/A), the
proposed uses were covered by the previous assessment on cotton and
nursery trees.  No transformation products or degradates were included
in the drinking water exposure assessment.

The Agency found no surface- or ground-water monitoring data for
esfenvalerate in support of the drinking water exposures.  The USGS
NAWQA program deleted all historical monitoring data for esfenvalerate
in 1997 because of poor recoveries in the analytical methods.  The
Agency has not determined whether studies have been published on the
potential impacts of conventional drinking water treatment methods
(sedimentation, flocculation, disinfection) on esfenvalerate
concentrations in drinking water sources.  

2009 Scientific Advisory Panel on the Evaluation of the Common Mechanism
of Action of Pyrethroid Pesticides

OPP presented a “Proposed Common Mechanism Grouping for the Pyrethrins
and Synthetic Pyrethroids to a FIFRA SAP in June 2009. OPP proposed two
subgroups based on Type I or Type II effects related to sodium current
tails and neurobehaviorial impact, with esfenvalerate and fenpropathrin
showing symptoms of both types.  The panel indicated that substances
with mixed characteristics could be included in both groups.  
Information on the SAP is available in the docket (with non-copyright
material available at http://  HYPERLINK "http://www.regulations.gov" 
www.regulations.gov ) under EPA-HQ-OPP-2008-0489.

Aquatic Life Criteria

The Clean Water Act requires the EPA to publish water quality criteria
that accurately reflect the latest scientific knowledge on the kind and
extent of all identifiable effects on health and welfare which might be
expected from the presence of pollutants in any body of water, including
ground water. While these recommended criteria do not, in themselves,
impose any requirements, states and authorized tribes can use them to
develop water quality standards. An Aquatic Life Ambient Water Quality
Criteria document has not been published for esfenvalerate.  

Impaired Water Bodies

Esfenvalerate is not identified as a cause of impairment for any water
bodies listed as impaired under section 303(d) of the Clean Water Act,
based on information provided at   HYPERLINK
"http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d
?p_cause_group_id=885" 
http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?
p_cause_group_id=885 .  In addition, no Total Maximum Daily Load (TMDL)
criteria have been developed for esfenvalerate, based on information
provided at   HYPERLINK
"http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detai
l?p_pollutant_group_id=885&p_pollutant_group_name=PESTICIDES" 
http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail
?p_pollutant_group_id=885&p_pollutant_group_name=PESTICIDES .  More
information on impaired water bodies and TMDLs can be found at  
HYPERLINK "http://www.epa.gov/owow/tmdl/"  http://www.epa.gov/owow/tmdl/
.  The Agency invites submission of water quality data for this
pesticide.  To the extent possible, data should conform to the quality
standards in Appendix A of the OPP Standard Operating Procedure:
Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s
Registration Review Risk Assessment and Management Process (see:  
HYPERLINK
"http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf" 
http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf ),
in order to ensure they can be used quantitatively or qualitatively in
pesticide risk assessments.

Effects Determinations for Esfenvalerate for the California Red-Legged
Frog

In response to a settlement agreement in the case of the Center for
Biological Diversity vs EPA (2006), the Agency assessed the potential
direct and indirect effects to the California red-legged frog (CRLF) and
potential adverse modification to designated critical habitat from uses
of the esfenvalerate in California   ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) . 
The assessment concluded:

A “No Effect” determination for all indoor uses because there is no
exposure pathway that would reach aquatic or terrestrial-phase CRLF nor
directly or indirectly alter its critical habitat.  

A “Likely to Adversely Affect” (“LAA”) determination for direct
effects on the CRLF and for effects on its food sources for all outdoor
uses based on exceedances of LOCs for the CRLF in both aquatic and
terrestrial environments.  

Mechanism of Action, Type of Pesticide, Usage, and Environmental Fate

Mechanism of Action and Type of Pesticide

Esfenvalerate is a broad spectrum nonselective insecticide that is used
to control a variety of insects in agriculture, commercial, residential,
and industrial settings both indoors and outdoors.  Esfenvalerate is a
type two synthetic pyrethroid (e.g., contains an alpha-cyano group);
however, it demonstrates toxicity properties of both Type I and Type II
pyrethroids   ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2009</Year><RecNum>37</RecNum
><DisplayText>(USEPA,
2009a)</DisplayText><record><rec-number>37</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">37</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">396</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Draft Science Polciy Paper: 
Proposed Common Mechanisms Grouping for The Pyrethrins and Synthetic
Pyrethroids</title><secondary-title>United States Environmental
Proteciton Agency</secondary-title><tertiary-title>Office of Pesticide
Programs</tertiary-title></titles><keywords><keyword>Pyrethroid,
esfenvalerate</keyword></keywords><dates><year>2009</year><pub-dates><da
te>May 19, 2009</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><label>Scientific Advisory
Panel</label><urls></urls></record></Cite></EndNote> (USEPA, 2009a) . 
The primary mechanism of action of pyrethroids is interference with the
closing of voltage-dependent sodium channels, resulting in repetitive
firing of neurons or blocking of an action potential   ADDIN EN.CITE
<EndNote><Cite><Author>ATSDR</Author><Year>1993</Year><RecNum>10</RecNum
><DisplayText>(ATSDR,
1993)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">10</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">370</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>ATSDR</author
></authors></contributors><titles><title>Toxicological Profile for
Pyrethrins and Pyrethroids</title><secondary-title>Agency for Toxic
Substances and Disease Registry
(ATSDR)</secondary-title><tertiary-title>United States Department of
Health and Human
Services</tertiary-title></titles><keywords><keyword>pyrethroid,
esfenvalerate</keyword></keywords><dates><year>1993</year><pub-dates><da
te>September, 1993</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.atsdr.cdc.gov/toxp
rofiles/tp155.html#bookmark08</url></related-urls></urls><access-date>Ju
ne 19, 2009</access-date></record></Cite></EndNote> (ATSDR, 1993) . 
After exposure the organism may exhibit hyper-excitation, tremors,
convulsions, and/or salivation, followed by lethargy, paralysis, and
death   ADDIN EN.CITE
<EndNote><Cite><Author>Kelley</Author><Year>2003</Year><RecNum>11</RecNu
m><DisplayText>(Kelley,
2003)</DisplayText><record><rec-number>11</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">11</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">371</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Kelley,
Kevin</author></authors></contributors><titles><title>Environmental Fate
of Esfenvalerate</title><tertiary-title>Environmental Monitoring Branch.
 Department of Pesticide Regulation.  California Environmental
Protection
Agency</tertiary-title></titles><dates><year>2003</year></dates><urls><r
elated-urls><url>http://www.cdpr.ca.gov/docs/emon/pubs/fatememo/esfen.pd
f</url></related-urls></urls><access-date>June 19,
2009</access-date></record></Cite></EndNote> (Kelley, 2003) .  Type two
pyrethroids, those that contain a cyano group in the alcohol and halogen
in the acid, are also reported to have effects at the presynaptic
membrane of voltage dependent calcium channels and to interfere with
ATPase enzymes involved with maintaining ionic concentration gradients
across membranes   ADDIN EN.CITE
<EndNote><Cite><Author>Solomon</Author><Year>2001</Year><RecNum>12</RecN
um><DisplayText>(Solomon<style face="italic"> et al.</style>,
2001)</DisplayText><record><rec-number>12</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">12</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">372</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Solomon,
K.R.</author><author>Giddings, J.M.</author><author>Maund,
S.J.</author></authors></contributors><titles><title>Probabilistic risk
assessment of cotton pyrethroids:I.  Distributional analyses of
laboratory aquatic toxicity data</title><secondary-title>Environmental
Toxicology and
Chemistry</secondary-title></titles><periodical><full-title>Environmenta
l Toxicology and
Chemistry</full-title></periodical><pages>652-659</pages><volume>20</vol
ume><number>3</number><keywords><keyword>Esfenvalerate</keyword></keywor
ds><dates><year>2001</year></dates><urls></urls></record></Cite></EndNot
e> (Solomon et al., 2001) . 

Type I pyrethroids cause T Syndrome which involves 1) slowly decaying
Na+ tail currents which depolarize the cell membrane above the threshold
for action potential generation, resulting in repetitive firing or long
trains of spontaneously induced action potentials.  In general, sodium
channels are open for a short time (milliseconds) for type I pyrethroids
  ADDIN EN.CITE
<EndNote><Cite><Author>Casarett</Author><Year>2001</Year><RecNum>112</Re
cNum><DisplayText>(Casarett<style face="italic"> et al.</style>,
2001)</DisplayText><record><rec-number>112</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">112</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">587</key></foreign-keys><ref-type
name="Book">6</ref-type><contributors><authors><author>Casarett, Louis
J.</author><author>Klaassen, Curtis D.</author><author>Doull,
John</author></authors><secondary-authors><author>Casarett, Louis
J.</author><author>Klaassen, Curtis D.</author><author>Doull,
John</author></secondary-authors></contributors><titles><title>Casarett
and Doull&apos;s Toxicology.  The Basic Science of
Poisons</title></titles><edition>6th</edition><dates><year>2001</year></
dates><pub-location>New York</pub-location><publisher>McGraw-Hill
Professional</publisher><urls></urls></record></Cite></EndNote>
(Casarett et al., 2001) .  Symptoms observed include restlessness,
incoordination, prostration, paralysis, sparring and aggressive
behavior, enhanced startle response, and tremors   ADDIN EN.CITE
<EndNote><Cite><Author>Casarett</Author><Year>2001</Year><RecNum>112</Re
cNum><DisplayText>(Casarett<style face="italic"> et al.</style>,
2001)</DisplayText><record><rec-number>112</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">112</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">587</key></foreign-keys><ref-type
name="Book">6</ref-type><contributors><authors><author>Casarett, Louis
J.</author><author>Klaassen, Curtis D.</author><author>Doull,
John</author></authors><secondary-authors><author>Casarett, Louis
J.</author><author>Klaassen, Curtis D.</author><author>Doull,
John</author></secondary-authors></contributors><titles><title>Casarett
and Doull&apos;s Toxicology.  The Basic Science of
Poisons</title></titles><edition>6th</edition><dates><year>2001</year></
dates><pub-location>New York</pub-location><publisher>McGraw-Hill
Professional</publisher><urls></urls></record></Cite></EndNote>
(Casarett et al., 2001) .

Type II pyrethroids cause CS Syndrome which involves 1) very slowly
decaying Na+ tail currents, 2) leading to membrane depolarization, and
3) conduction block of action potentials in the axon.  In general sodium
channels are open for a longer time (seconds) than observed for type I
pyrethroids   ADDIN EN.CITE
<EndNote><Cite><Author>Casarett</Author><Year>2001</Year><RecNum>112</Re
cNum><DisplayText>(Casarett<style face="italic"> et al.</style>,
2001)</DisplayText><record><rec-number>112</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">112</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">587</key></foreign-keys><ref-type
name="Book">6</ref-type><contributors><authors><author>Casarett, Louis
J.</author><author>Klaassen, Curtis D.</author><author>Doull,
John</author></authors><secondary-authors><author>Casarett, Louis
J.</author><author>Klaassen, Curtis D.</author><author>Doull,
John</author></secondary-authors></contributors><titles><title>Casarett
and Doull&apos;s Toxicology.  The Basic Science of
Poisons</title></titles><edition>6th</edition><dates><year>2001</year></
dates><pub-location>New York</pub-location><publisher>McGraw-Hill
Professional</publisher><urls></urls></record></Cite></EndNote>
(Casarett et al., 2001) .  Calcium channels appear to be involved in
producing the complex CS convulsions.  Symptoms include intense
hyperactivity, incoordination, convulsions, burrowing behavior, coarse
tremors, clonic seizures, choreoathetosis, and salivation.  In the 2009
pyrethroid SAP, OPP proposed that esfenvalerate be considered mixed type
I and type II pyrethroid based on observed effects   ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>1998</Year><RecNum>13</RecNum
><DisplayText>(USEPA,
1998)</DisplayText><record><rec-number>13</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">13</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">373</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Guidelines for Ecological Risk
Assessment</title><secondary-title>United States Environmental
Protection Agency (USEPA)</secondary-title><tertiary-title>Risk
Assessment Forum.  Office of Research and
Development</tertiary-title></titles><number>EPA/630/R-95/002F</number><
dates><year>1998</year><pub-dates><date>April,
1998</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://cfpub.epa.gov/ncea/cfm
/recordisplay.cfm?deid=12460</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 1998) .

Overview of Pesticide Usage

Esfenvalerate was first registered in 1986 and began to replace
fenvalerate, which was originally registered in 1979.  Esfenvalerate is
a broad spectrum nonselective insecticide that is used to control a
variety of insects in agriculture, commercial, residential, and
industrial settings, and includes both indoor and outdoor uses.  Based
on an Office of Pesticide Programs Information Network (OPPIN) search on
April 30, 2009 supplied by the Pesticide Re-evaluation Division (PRD)
there were 71 esfenvalerate-only ai active registrations and 56
multi-active ingredient registrations held by 26 registrants. 
Agricultural uses include various berries, corn, cotton, fruit and nut
tree orchards, peanuts, sorghum, sugar beets, sugarcane, sunflower, and
a variety of vegetables.  Agricultural uses are listed in Table 3-1. In
general, all crops may be treated via chemigation (via an irrigation
system), aerial, and ground application methods.    REF _Ref184726292 \h
 Table 3-1  specifies the maximum application rates for each
agricultural use.  Labels did not specify a maximum number of
applications per year; however, this may be inferred from the maximum
single application rate and the maximum seasonal application rates.

Table   STYLEREF 1 \s  3 -  SEQ Table \* ARABIC \s 1  1 .  Labeled
Agricultural Uses1,2

Crop Group	Crop/ Use	Maximum Single Application Rate 

(lbs ai/acre)	Maximum Seasonal Rate 

(lbs ai/acre)	Seasons per Year3	Application Interval (days)

Tree Nuts	Almonds	0.1	0.2	14	NS5

	Filbert (Hazelnut)	0.1 	0.2	16	NS, 7

	Pecan	0.18	0.3	16	7

	Walnut	0.1	0.2	17	7

Cole Crops	Broccoli	0.05	0.4	1 to 2	NS, 7

	Broccoli, Chinese	0.05	0.4	1 to 2	NS

	Cabbage	0.05	NS	1 to 3	NS, 7

	Cabbage, Chinese	0.05	0.4	1 to 3	NS

	Cauliflower	0.05	0.4	1 to 2	NS, 7

	Collards	0.05	0.2	2 to 3	NS, 7

	Kohlrabi	0.05	0.4	2 to 36	NS

	Mustard	0.05	0.2	2 to 36	NS

Corn	Corn, unspecified	0.05	0.25	1	NS

	Corn, field	0.05	0.25	1	NS

	Corn, pop	0.05	0.5	1	NS

	Corn, sweet	0.05	0.5	1 to 2	NS, 7

Fruit Trees	Apple	0.18	0.525 lbs	1	NS, 7

	Apricot	0.12	0.375 / 0.3 between bloom and harvest	16	NS, 7

	Cherry

	0.12

	0.375 / 0.3 between bloom and harvest	16

	NS, 7

	Nectarine	0.12	0.375 / 0.3 between bloom and harvest	1	NS, 7

	Peach	0.12	0.375 / 0.3 between bloom and harvest	1	NS, 7

	Pear	0.075

0.1 (dormant)	0.375 season / 0.225 between bloom and harvest / 0.2
dormant	1	NS, 7

	Plum	0.12	0.375 / 0.3 between bloom and harvest	18	NS, 7

	Prune	0.12	0.375 / 0.3 between bloom and harvest	18	NS, 7

Cucumbers, Squash,  and Melons

	Cucumber	0.05	0.25	1	NS, 7

	Melons	0.05	0.25	1	NS, 7

	Melons, cantaloupe	0.05	0.25	1	NS

	Melons, honeydew	0.05	0.25	1	NS

	Melons, musk	0.05	0.25	16	NS

	Melons, water	0.05	0.25	16	NS

	Pumpkin	0.05	0.25	1	NS, 7

	Squash (winter, summer, unspecified)	0.05	0.25	16	NS

Potato / Root crops	Potato, white/Irish	0.05	0.35	1	NS, 7

	Turnip	0.05	0.5	16	NS

Other Vegetables

	Artichoke	0.05	0.15	18	7-14

	Beans, dried or succulent	0.05	0.2	1	NS, 7

	Carrot	0.05	0.5	1	NS, 7

	Eggplant	0.05	0.35	1	7

	Lentils	0.05	0.2	1	NS

	Lettuce, head	0.05	0.35	1-2	NS

	Okra	0.05	NS	1	NS

	Peas, dried, succulent, or unspecified	0.05	0.2	16	NS, 7

	Pepper	0.05	0.35	1	7

	Radish	0.05	0.1	3-5	NS, 7

	Tomato	0.05	0.5	1	NS, 7

Berries	Blackberry	0.05	0.15	1	NS, 7

	Blueberry	0.05	0.2	1	NS, 7

	Boysenberry	0.05	0.15	1	NS

	Caneberries	0.05	0.15	1	NS

	Dewberry	0.05	0.15	1	NS

	Elderberry, Gooseberry	

NS

	NS	1	7

	Loganberry	0.05	0.15	1	NS

	Raspberry	0.05	0.15	1	NS, 7

	Youngberry	0.05	0.15	1	NS

Other Crops Not in Groups

 	Cotton (unspecified)	0.05	0.5	1	NS

	Kiwi	0.05	0.35	18	7

	Peanuts	0.05	0.15	1	NS

	Sorghum	0.05	0.15	1 crop for grain, hay several times per year	NS

	Soybeans	0.05	0.2	1	NS

	Sugar beet	0.05	0.15	1	NS

	Sugarcane	0.05	0.2	1	NS

	Sunflower	0.05	0.2	1 to 26	NS

Forest Tree Nursery and Tree Nursery

	Christmas tree plantings, Conifer plantations seed orchards, Forest
tree nurseries	0.19	1.6	1	NS, 7 for 2 sprays or every 28

Non-cropland	Prevent pests from getting to cropland	0.05	0.5	NS	NS

1  This Table was created based on information provided by OPP’s
Biological and Economic Analysis Division (BEAD) in its Label Use
Information System (LUIS) completed on December 22, 2008.

2 Unless at plant application is specified in the Crop/Use column,
esfenvalerate may be applied using aerial, ground, and chemigation
methods.

3  Seasons per year were obtained from Memorandum from Monisha Kaul in
BEAD to Melissa Panger in EFED dated 2/28/2007, unless stated otherwise.

4  Mosz, N. Almond Timeline, 2002.  Online: 
http://pestdata.ncsu.edu/croptimelines/pdf/CAalmond.pdf

5  NS stands for not specified

6  Seasons per year were assumed from similar crops in the crop
grouping.

7  Mosz, N. Walnut Timeline, 2002.  Online: 
http://pestdata.ncsu.edu/croptimelines/pdf/CAwalnut.pdf

8  USDA crop profiles, available online at
http://cipm.ncsu.edu/cropprofiles/cropprofiles.cfm (accessed on December
1, 2007).

Non-agricultural labels allow for a wide variety of uses in residential,
commercial, industrial, and feedlot settings, and include both indoor
and outdoor uses.  Table 3-2 lists those outdoor non-agricultural uses
EFED plans to assess for registration review.  Esfenvalerate can be
applied outdoors to structures and equipment, lawns, home ornamentals
and gardens, cracks and crevices, mosquito breeding areas, and spot
treatments for pests.  Indoor uses include as a crack and crevice
treatment, spot treatments, surface spray, foggers to treat insects such
as ants, crickets, cockroaches, ticks, and various other insects. 
Formulations are sold as emulsifiable concentrates, wettable powders,
microencapsulation, ready-to-use liquids, and pressurized liquids. 
Application methods include spray, pressurized spray, hose-end spray,
power sprayer, aerosol spray, tank top sprayer, compressed air sprayer,
and fogger.  Maximum single application rates for non-agricultural uses
are provided in   REF _Ref184533773 \h  Table 3-2 .  Most labels
specified a maximum amount applied per specified area but did not
provide a maximum seasonal or yearly rate.  Indoor uses listed in   REF
_Ref236239163 \h  Table 3-3  are assumed to have incomplete exposure
pathways for aquatic and terrestrial organisms and will not be included
in the ecological risk assessment.

Table   STYLEREF 1 \s  3 -  SEQ Table \* ARABIC \s 1  2 .  Labeled
Non-agricultural Uses Assessed in this Document.1,2

Use Group	Specific Uses	Maximum Single Application Rate (lbs ai / acre)
Maximum Seasonal Rate (lbs ai / acre)	Application Methods	Application
Interval (days)

Forests	Forest Trees (all or unspecified), Softwoods, Conifers	0.05	1.6
ground, aerial	As needed

Residential, Commercial, and Industrial Areas:  Agricultural/farm
structures/buildings and equipment, Commercial Storage/warehouse
premises, Non-agricultural Outdoor Buildings/structures,
Non-agricultural Uncultivated Areas/soils, Recreation Areas	General
Outdoor Surfaces:  Unspecified, Paths and Patios,  Refuse/Solid Waste
Sites 	0.51	NS	spray	NS

	Building Perimeter	0.2

	NS	spray, microencapsulation	NS and 7

	Home and Garden: Ornamental Trees and Plants, Herbaceous Plants,
Nonflowering Plants, Woody Shrubs and Vines, Fruits, Nuts, Berries and
Vegetables, Shade Trees 	NS	NS	spray	NS and 7 to 14

	Lawn and Grass	0.2	NS	spray, microencapsulation	NS

	Outside of Automobiles, Vehicles, Taxis, Limousines, Truck Trailers,
Railroad Cars, Tires	NS	NS	spray, fogger	NS

	Kennels and Animal Housing Areas	0.1

	NS	spray, fogger	NS

	Ant Mounds and Wasp and Hornet Nests	NS	NS	spray, fogger, 
microencapsulation	NS

	Mosquito breeding areas 	0.2	NS	spray,  microencapsulation	NS

1  The Labeling and Use Information (LUIS) report lists Wide
Area/General Outdoor Treatment (Public Health Use).  This listing could
easily be mistaken for a general wide area use that may involve
significant use near aquatic environments.  The labels referenced for
this use includes EPA Registration Numbers 1021-1764, 1021-1635,
1021-1852, and 1021-1701.  The outdoor uses allowed on these labels
include treatment of wasp, hornet, yellow jacket nests, fire ant
housing, and to kill fire ants, mud daubers, scorpions, spiders,
crickets, carpenter ants, harvester ants, centipedes, earwigs, and
sowbugs.  These uses are covered by the general outdoor uses already
listed in   REF _Ref184533773 \h  \* MERGEFORMAT  Table 3-2 .

2 NS=Not Specified.

Table   STYLEREF 1 \s  3 -  SEQ Table \* ARABIC \s 1  3 .  Labeled Non-
agricultural Uses Qualitatively Assessed in this Document

Use Group	Specific Uses	Reasons for Exclusion

Interior Vehicle Uses	Vehicles, Boats, Campers, Railroad Cars, and Truck
Trailers	Minimal chance for exposure in terrestrial or aquatic
environments

Indoor Uses:  Commercial, residential, and industrial buildings,
Cadavers and Caskets, Voids in Equipment and Structures, Grain Storage
Facilities	Surface Spray, Space Spray, Crack and Crevice Treatment, and
Spot Treatment	Minimal chance for exposure in terrestrial and aquatic
environments

The uses identified in this problem formulation summarize the Agency’s
understanding of the currently registered uses of esfenvalerate.  These
uses, along with any new uses submitted between the time of this problem
formulation and the risk assessment, will be included in the
registration review risk assessment, including a national endangered
species assessment.  The Agency would like input on the uses listed in
this section, as well as any currently registered uses for esfenvalerate
not represented in this use summary. 

Environmental Fate and Transport

Esfenvalerate, cyano-3-phenoxybenzyl-2-(4-chlorophyl)-3-methylbutyrate,
has two chiral centers – one at the 2C position of the acid and one at
the alpha C position of the alcohol (see Figure 3-1a), resulting in four
possible isomers: RS, SR, SS, and RR.  While fenvalerate is made up of
approximately equal amounts of each isomer, esfenvalerate is enriched
with the SS-isomer (75 – 90%)   ADDIN EN.CITE   ADDIN EN.CITE.DATA  
(Adelsbach and Tjeerdema, 2003; ATSDR, 1993; Solomon et al., 2001)  ,
which is a more effective insecticide than the other isomers   ADDIN
EN.CITE
<EndNote><Cite><Author>Katagi</Author><Year>1993</Year><RecNum>154</RecN
um><DisplayText>(Katagi, 1993; Solomon<style face="italic"> et
al.</style>,
2001)</DisplayText><record><rec-number>154</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">154</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Katagi,
T.</author></authors></contributors><titles><title>Photodegradation of
esfenvalerate in clay suspensions</title><secondary-title>Journal of
Agricultural and Food
Chemistry</secondary-title></titles><periodical><full-title>Journal of
Agricultural and Food
Chemistry</full-title></periodical><pages>2178-2183</pages><volume>41</v
olume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year>
1993</year></dates><label>fate</label><urls></urls></record></Cite><Cite
><Author>Solomon</Author><Year>2001</Year><RecNum>12</RecNum><record><re
c-number>12</rec-number><foreign-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">12</key><key app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">372</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Solomon,
K.R.</author><author>Giddings, J.M.</author><author>Maund,
S.J.</author></authors></contributors><titles><title>Probabilistic risk
assessment of cotton pyrethroids:I.  Distributional analyses of
laboratory aquatic toxicity data</title><secondary-title>Environmental
Toxicology and
Chemistry</secondary-title></titles><periodical><full-title>Environmenta
l Toxicology and
Chemistry</full-title></periodical><pages>652-659</pages><volume>20</vol
ume><number>3</number><keywords><keyword>Esfenvalerate</keyword></keywor
ds><dates><year>2001</year></dates><urls></urls></record></Cite></EndNot
e> (Katagi, 1993; Solomon et al., 2001) ..  Unless otherwise specified,
all fate studies discussed were conducted using the SS-isomer.  Figure
3-1 shows the chemical structure of esfenvalerate and related compounds;
Table 3-4 lists the physico-chemical properties.

Figure   STYLEREF 1 \s  3 -  SEQ Figure \* ARABIC \s 1  1 . Chemical
Structures of Esfenvalerate and Related Compounds

a.  Cyano-3-phenoxybenzyl-2-(4-chlorophyl)-3-methylbutyrate with chiral
centers denoted with (*) at the 2C position of the acid and at the alpha
C position of the alcohol (Eisler 1992).1

 

b. (S)-alpha-cyano-3-phenoxybenzyl
(S)-2-(4-chlorophenyl)-3-methylbutyrate (esfenvalerate)2

c.  4-chloro-alpha-(1-methylethyl)-benzeneacetic acid (CPIA)

d.  4-chloro-beta-(1-methylethyl)-alpha
-(3-phenoxyphenyl)-benzenepropane-nitrile (decarboxyfenvalerate)3

 

1  Structure obtained from Chemfinder available at   HYPERLINK
"http://chemfinder.cambridgesoft.com/" 
http://chemfinder.cambridgesoft.com/  (accessed 1/11/2008)

2  Structure obtained from IPCSINTOX Databank from the UK National
Poisons Information Service Monograph for esfenvalerate available at  
HYPERLINK
"http://www.intox.org/databank/documents/chemical/esfenval/ukpid63.htm" 
http://www.intox.org/databank/documents/chemical/esfenval/ukpid63.htm 
(accessed 1/11/2008).

3  Structure obtained from Toxnet available at   HYPERLINK
"http://toxnet.nlm.nih.gov/index.html" 
http://toxnet.nlm.nih.gov/index.html  (accessed 1/14/2008).

Table   STYLEREF 1 \s  3 -  SEQ Table \* ARABIC \s 1  4 .  Summary of
Physico-Chemical Properties of Esfenvalerate.

Property	Value (Method)	MRID #, Author1	Study Status, Date of Memorandum

Empirical Formula	C25H22ClNO3

Molecular Weight	419.9 g/mol

Melting Point	59.5 – 61.5 oC (OECD 102)	467253-05, Comb 2002
Acceptable, 6/1/06

Boiling Point	Not determinable (OECD 103)	467253-03, Comb 2002
Acceptable, 6/1/06

Relative Density	1.13 g/cm3 at 23oC(OECD 109)2	467253-03, Comb 2002
Acceptable, 6/1/06

Vapor Pressure	6.3 x 10-5 Pa at 25oC (OECD 109)

6.7 x 10-5 Pa	467253-04, Comb 2002

Open Lit.,   ADDIN EN.CITE
<EndNote><Cite><Author>Jones</Author><Year>2002</Year><RecNum>158</RecNu
m><DisplayText>(Jones,
2002)</DisplayText><record><rec-number>158</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">158</key></foreign-keys><re
f-type name="EPA Memo">2</ref-type><contributors><authors><author>Jones,
R.D.</author></authors></contributors><titles><title>Chemical properties
of the pyrethroid insecticides to support surface water
modeling</title><tertiary-title>Environmental Fate and Effects Division.
 Office of Pesticide Programs</tertiary-title></titles><edition>United
States Environmental Protection
Agency</edition><dates><year>2002</year></dates><urls></urls></record></
Cite></EndNote> (Jones, 2002) ,   ADDIN EN.CITE
<EndNote><Cite><Author>European
Commission</Author><Year>2005</Year><RecNum>28</RecNum><DisplayText>(Eur
opean Commission,
2005)</DisplayText><record><rec-number>28</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">28</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">387</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>European
Commission,</author></authors></contributors><titles><title>Review
Report for the Active Substance
Esfenvalerate</title><secondary-title>European Commission. 
Directorate-General Heath &amp; Consumer
Protection.</secondary-title></titles><dates><year>2005</year></dates><l
abel>Esfenvalerate</label><urls><related-urls><url>http://ec.europa.eu/f
ood/plant/protection/evaluation/existactive/list1-15_en.pdf</url></relat
ed-urls></urls><access-date>Jun 19,
2009</access-date></record></Cite></EndNote> (European Commission, 2005)
	Acceptable, 6/1/06

Screened

Henry’s Law Constant	>1.87 Pa-m3/mol at 25oC (est.)

1.4 x 10-7 Pa-m3/mol	467253-04, Comb 2002

Open Lit.,   ADDIN EN.CITE
<EndNote><Cite><Author>Laskowski</Author><Year>2002</Year><RecNum>157</R
ecNum><DisplayText>(Laskowski,
2002)</DisplayText><record><rec-number>157</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">157</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Laskowski,
D.A.</author></authors></contributors><titles><title>Physical and
chemical properties of pyrethroids</title><secondary-title>Reviews of
Environmental Contamination and
Toxicology</secondary-title></titles><periodical><full-title>Reviews of
Environmental Contamination and
Toxicology</full-title></periodical><pages>49-170</pages><volume>174</vo
lume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year>2
002</year></dates><label>fate</label><urls></urls></record></Cite></EndN
ote> (Laskowski, 2002) 	Not Reviewed

Screened

Water Solubility	< 0.01 mg/L at 20oC (OECD 105)

0.006 mg/L

0.002 mg/L	467253-03, Comb 2002

Open Lit.,   ADDIN EN.CITE
<EndNote><Cite><Author>Laskowski</Author><Year>2002</Year><RecNum>157</R
ecNum><DisplayText>(Laskowski,
2002)</DisplayText><record><rec-number>157</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">157</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Laskowski,
D.A.</author></authors></contributors><titles><title>Physical and
chemical properties of pyrethroids</title><secondary-title>Reviews of
Environmental Contamination and
Toxicology</secondary-title></titles><periodical><full-title>Reviews of
Environmental Contamination and
Toxicology</full-title></periodical><pages>49-170</pages><volume>174</vo
lume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year>2
002</year></dates><label>fate</label><urls></urls></record></Cite></EndN
ote> (Laskowski, 2002) ,   ADDIN EN.CITE <EndNote><Cite><Author>European
Commission</Author><Year>2005</Year><RecNum>28</RecNum><DisplayText>(Eur
opean Commission,
2005)</DisplayText><record><rec-number>28</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">28</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">387</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>European
Commission,</author></authors></contributors><titles><title>Review
Report for the Active Substance
Esfenvalerate</title><secondary-title>European Commission. 
Directorate-General Heath &amp; Consumer
Protection.</secondary-title></titles><dates><year>2005</year></dates><l
abel>Esfenvalerate</label><urls><related-urls><url>http://ec.europa.eu/f
ood/plant/protection/evaluation/existactive/list1-15_en.pdf</url></relat
ed-urls></urls><access-date>Jun 19,
2009</access-date></record></Cite></EndNote> (European Commission, 2005)

Open Lit.,   ADDIN EN.CITE
<EndNote><Cite><Author>Kelley</Author><Year>2003</Year><RecNum>11</RecNu
m><DisplayText>(Kelley,
2003)</DisplayText><record><rec-number>11</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">11</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">371</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Kelley,
Kevin</author></authors></contributors><titles><title>Environmental Fate
of Esfenvalerate</title><tertiary-title>Environmental Monitoring Branch.
 Department of Pesticide Regulation.  California Environmental
Protection
Agency</tertiary-title></titles><dates><year>2003</year></dates><urls><r
elated-urls><url>http://www.cdpr.ca.gov/docs/emon/pubs/fatememo/esfen.pd
f</url></related-urls></urls><access-date>June 19,
2009</access-date></record></Cite></EndNote> (Kelley, 2003) 	Acceptable,
6/1/06

Screened

Screened

Log KOW	>6 (OECD 117)

5.62 - >6

6.24 at 25oC	467253-04, Comb 2002

Open Lit.,   ADDIN EN.CITE
<EndNote><Cite><Author>Laskowski</Author><Year>2002</Year><RecNum>157</R
ecNum><DisplayText>(Laskowski,
2002)</DisplayText><record><rec-number>157</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">157</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Laskowski,
D.A.</author></authors></contributors><titles><title>Physical and
chemical properties of pyrethroids</title><secondary-title>Reviews of
Environmental Contamination and
Toxicology</secondary-title></titles><periodical><full-title>Reviews of
Environmental Contamination and
Toxicology</full-title></periodical><pages>49-170</pages><volume>174</vo
lume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year>2
002</year></dates><label>fate</label><urls></urls></record></Cite></EndN
ote> (Laskowski, 2002) 

Open Lit.,   ADDIN EN.CITE <EndNote><Cite><Author>European
Commission</Author><Year>2005</Year><RecNum>28</RecNum><DisplayText>(Eur
opean Commission,
2005)</DisplayText><record><rec-number>28</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">28</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">387</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>European
Commission,</author></authors></contributors><titles><title>Review
Report for the Active Substance
Esfenvalerate</title><secondary-title>European Commission. 
Directorate-General Heath &amp; Consumer
Protection.</secondary-title></titles><dates><year>2005</year></dates><l
abel>Esfenvalerate</label><urls><related-urls><url>http://ec.europa.eu/f
ood/plant/protection/evaluation/existactive/list1-15_en.pdf</url></relat
ed-urls></urls><access-date>Jun 19,
2009</access-date></record></Cite></EndNote> (European Commission, 2005)
	Acceptable, 6/1/06

Screened

Screened

1 Open literature (lit.) indicates the study was obtained from the open
literature and the study was not submitted to the EPA for review. 

2 Memorandum reviewing the product chemistry sent by Indira Gairola to
George Larocca on June 1, 2006 indicated that the relative density was
slightly lower (1.13) than that reported by   ADDIN EN.CITE
<EndNote><Cite><Author>MRID
46725304</Author><Year>2002</Year><RecNum>156</RecNum><DisplayText>(MRID
46725304,
2002)</DisplayText><record><rec-number>156</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">156</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author> MRID
46725304,</author></authors><secondary-authors><author>Comb,
A.</author></secondary-authors></contributors><titles><title>Esfenvalera
te (pure grade):  Physico-chemical properties.  Project Number:
VFX013/022699.  </title><secondary-title>LG Chemical Investment,
Ltd</secondary-title></titles><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2002</year></dates><pub-location>Huntingdon Life
Sciences,
Ltd.</pub-location><label>fate</label><urls></urls></record></Cite></End
Note> (MRID 46725304, 2002) .

Degradation

Soil: The environmental fate database for esfenvalerate is largely
complete, except for an assessment of microbial degradation in water and
sediment.  The major route of dissipation for esfenvalerate on soil
appears to be sorption onto soil and organic matter, with slower
microbial degradation (rates generally on the order of months).  In some
instances, photolysis may occur in shallow water where light is
available or on soil before the chemical sorbs to soil.  

Water: Esfenvalerate is not expected to remain in the water column
because of its high sorption coefficients.  Most of it will sorb to
organic materials or sediment.  Although aquatic metabolism studies are
not available for esfenvalerate, Samsoe-Petersen et al. (2001) observed
50 percent mineralization of esfenvalerate in pond sediment between 73
and 350 days, suggesting that esfenvalerate sorbed onto sediment is
likely to persist   ADDIN EN.CITE
<EndNote><Cite><Author>Samsoe-Peterson</Author><Year>2001</Year><RecNum>
159</RecNum><DisplayText>(Samsoe-Peterson<style face="italic"> et
al.</style>,
2001)</DisplayText><record><rec-number>159</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">159</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Samsoe-Peterson,
L.</author><author>Gustavsan K.</author><author>Madsen,
T</author><author>Mogensen, B.B.</author><author>Lassen,
K.</author><author>Skjernov, K.</author><author>Christoffersen,
K.</author><author>Jorgensen,
E.</author></authors></contributors><titles><title>Fate and effects of
esfenvalerate in agricultural
ponds</title><secondary-title>Environmental Toxicology and
Chemistry</secondary-title></titles><periodical><full-title>Environmenta
l Toxicology and
Chemistry</full-title></periodical><pages>1570-1578</pages><volume>20</v
olume><number>7</number><keywords><keyword>Esfenvalerate</keyword></keyw
ords><dates><year>2001</year></dates><label>fate,
effects</label><urls></urls></record></Cite></EndNote> (Samsoe-Peterson
et al., 2001) .  

Degradates: The only major aerobic or anaerobic metabolism degradate was
carbon dioxide   ADDIN EN.CITE
<EndNote><Cite><Author>42396801</Author><Year>1992</Year><RecNum>160</Re
cNum><DisplayText>(MRID 146578, 1992; MRID 42396801,
1992)</DisplayText><record><rec-number>160</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">160</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
42396801,</author></authors><secondary-authors><author>Gassamidi,
V.</author><author>Bookhard,
S.</author></secondary-authors></contributors><titles><title>Anaerobic
soil metabolism of esfenvalerate:  Lab Project Number: 
DUPONT-3438</title></titles><dates><year>1992</year></dates><pub-locatio
n>E.I. du Pont de Nemours and
Company</pub-location><urls></urls></record></Cite><Cite><Author>MRID
146578</Author><Year>1992</Year><RecNum>125</RecNum><record><rec-number>
125</rec-number><foreign-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">125</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
146578,</author></authors><secondary-authors><author>Lee,
P.W.</author><author>Sterns, S.M.</author><author>Powell,
W.R.</author></secondary-authors></contributors><titles><title>Comparati
ve aerobic soil metabolism of SD 43775 (racemic) and SD 47443
(A-alpha)</title><secondary-title>Shell Development Company, Modesto,
CA</secondary-title></titles><number>MO-RIR-22-011-85.  Accession Number
258842</number><keywords><keyword>Esfenvalerate,
chlorpyrifos</keyword></keywords><dates><year>1992</year></dates><label>
MRID, Fate</label><urls></urls></record></Cite></EndNote> (MRID 146578,
1992; MRID 42396801, 1992) .  When sunlight is available, photolysis may
occur and photolysis degradates include up to 27 % CPIA and 12 %
decarboxy-fenvalerate   ADDIN EN.CITE <EndNote><Cite><Author>Dynamac
Corporation</Author><Year>1988</Year><RecNum>30</RecNum><DisplayText>(Dy
namac Corporation,
1988)</DisplayText><record><rec-number>30</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">30</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">389</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Dynamac
Corporation,</author></authors></contributors><titles><title>Fenvalerate
Addendum.  Task 1:  Review and Evaluation of Individual Studies. 
Contract No. 68-02-4250.  Review of Stevenson, I. 1987. 
Photodegradation of (chlorophenyl (u)-(Carbon 14) (DPX-GB800 in Water at
pH 5:  Laboratory Project ID:  AMR-868-87.  Unpublished study prepared
by E.I. du Pont de Nemours &amp;
Co.</title></titles><dates><year>1988</year></dates><urls></urls></recor
d></Cite></EndNote> (Dynamac Corporation, 1988) .  Based on the data
available, decarboxy fenvalerate is less toxic (rat oral LD50 was 67-87
mg/kg for esfenvalerate and >500 mg/kg for decarboxyfenvalerate) and
concentrations of decarboxyfenvalerate will be much lower, approximately
87% lower, than the parent compound   ADDIN EN.CITE
<EndNote><Cite><Author>Kelley</Author><Year>2003</Year><RecNum>11</RecNu
m><DisplayText>(Holmstead<style face="italic"> et al.</style>, 1978;
Kelley,
2003)</DisplayText><record><rec-number>11</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">11</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">371</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Kelley,
Kevin</author></authors></contributors><titles><title>Environmental Fate
of Esfenvalerate</title><tertiary-title>Environmental Monitoring Branch.
 Department of Pesticide Regulation.  California Environmental
Protection
Agency</tertiary-title></titles><dates><year>2003</year></dates><urls><r
elated-urls><url>http://www.cdpr.ca.gov/docs/emon/pubs/fatememo/esfen.pd
f</url></related-urls></urls><access-date>June 19,
2009</access-date></record></Cite><Cite><Author>Holmstead</Author><Year>
1978</Year><RecNum>31</RecNum><record><rec-number>31</rec-number><foreig
n-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">31</key><key app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">390</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Holmstead,
R.L.</author><author>Fullmer, D.G.</author><author>Ruzo,
L.O.</author></authors></contributors><titles><title>Pyrethroid
photodecomposition:  Pyrdrin</title><secondary-title>Journal of
Agricultural and Food
Chemistry</secondary-title></titles><periodical><full-title>Journal of
Agricultural and Food
Chemistry</full-title></periodical><pages>954-959</pages><volume>26</vol
ume><number>4</number><dates><year>1978</year></dates><urls></urls></rec
ord></Cite></EndNote> (Holmstead et al., 1978; Kelley, 2003) .  No
toxicity data were available for CPIA; however, breaking the ester bond
is expected to significantly decrease the toxicity of the substance as
compared to the parent compound.  Additionally, aquatic toxicity data
estimated using ECOSAR indicate that CPIA is expected to be much less
toxic than esfenvalerate (  REF _Ref236291917 \h  \* MERGEFORMAT 
Appendix D ).  As the expected toxicity and exposure of the degradates
do not exceed that of esfenvalerate, they were not considered to
contribute substantially to the toxicity exposure.  The SS-isomer may
sterioisomerize into the RS and SR-isomers in water.  However,
application rates are based on the SS-isomer and half-lives used in the
exposure estimates are based on breakdown of the combined isomers. Thus,
in the aquatic environment, the estimated concentration of the SS-
isomer represents the sum of all isomers present or the maximum
concentration of the SS-isomer.  As the SS-isomer is the most toxic
isomer for insects and only limited toxicity data is available for other
individual isomers, this may be assumed to be the most protective
assumption   ADDIN EN.CITE
<EndNote><Cite><Author>ATSDR</Author><Year>1993</Year><RecNum>10</RecNum
><DisplayText>(Adelsbach and Tjeerdema, 2003; ATSDR,
1993)</DisplayText><record><rec-number>10</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">10</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">370</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>ATSDR</author
></authors></contributors><titles><title>Toxicological Profile for
Pyrethrins and Pyrethroids</title><secondary-title>Agency for Toxic
Substances and Disease Registry
(ATSDR)</secondary-title><tertiary-title>United States Department of
Health and Human
Services</tertiary-title></titles><keywords><keyword>pyrethroid,
esfenvalerate</keyword></keywords><dates><year>1993</year><pub-dates><da
te>September, 1993</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.atsdr.cdc.gov/toxp
rofiles/tp155.html#bookmark08</url></related-urls></urls><access-date>Ju
ne 19,
2009</access-date></record></Cite><Cite><Author>Adelsbach</Author><Year>
2003</Year><RecNum>33</RecNum><record><rec-number>33</rec-number><foreig
n-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">33</key><key app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">392</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Adelsbach,
T.L.</author><author>Tjeerdema,
R.S.</author></authors></contributors><titles><title>Chemistry of
fenvalerate and esfenvalerate</title><secondary-title>Reviews of
Environmental Contamination and
Toxicology</secondary-title></titles><periodical><full-title>Reviews of
Environmental Contamination and
Toxicology</full-title></periodical><pages>137-154</pages><volume>176</v
olume><dates><year>2003</year></dates><urls></urls></record></Cite></End
Note> (Adelsbach and Tjeerdema, 2003; ATSDR, 1993) ;  ADDIN EN.CITE
<EndNote><Cite><Author>Eisler</Author><Year>1992</Year><RecNum>32</RecNu
m><DisplayText>(Eisler,
1992)</DisplayText><record><rec-number>32</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">32</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">391</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Eisler,
R.</author></authors></contributors><titles><title>Fenvalerate Hazards
to Fish, Wildlife, and Invertebrates:  A Synoptic Review. Biological
Report No 85(2)</title><tertiary-title>United States Fish and Wildlife
Service
(USFWS)</tertiary-title></titles><dates><year>1992</year></dates><pub-lo
cation>Washington, D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.pwrc.usgs.gov/info
base/eisler/CHR_24_Fenvalerate.pdf</url></related-urls></urls><access-da
te>June 19, 2009</access-date></record></Cite></EndNote> (Eisler, 1992)
..

  REF _Ref184122647 \h  \* MERGEFORMAT  Table 3-5  summarizes the
environmental fate properties of esfenvalerate, along with the major and
minor degradates detected in the submitted environmental fate and
transport studies.  

Table   STYLEREF 1 \s  3 -  SEQ Table \* ARABIC \s 1  5 .  Summary of
Esfenvalerate Environmental Fate Properties.

Study	

Value, SS-isomer/All Isomers1 (units)

	

Major Degradates

Minor Degradates	

MRID #, Author2	Study Status (Date of Memorandum Referenced)

Hydrolysis	Minimal degradation in 30 days at pH 5, 7, 9, All isomers	Not
Applicable	40999303, Lee 1989	Acceptable (3/14/1991)

Direct Aqueous Photolysis	T1/2 = 6 days at pH 5, SS-isomer

T1/2 = 9 days, All isomers	CO2, CPIA, decarboxyfenvalerate	40443801,

Stevenson 1987

40443801,

Stevenson 1987	Acceptable (1/5/1988, 7/27/1992)

Calculated for this review

Soil Photolysis 	Minimal in 30 days, SS-isomer3

Range from < 1 day in kaolinite to 100 days in a Noichi upland soil,
SS-isomer	CO2, CPIA,  decarboxy-fenvalerate

3-phenoxybenzyl alcohol, 3-phenoxybenzoic acid, and decarboxy
fenvalerate+	41728501 Castle et al. 1990 

Open Lit.,   ADDIN EN.CITE
<EndNote><Cite><Author>Katagi</Author><Year>1991</Year><RecNum>155</RecN
um><DisplayText>(Katagi,
1991)</DisplayText><record><rec-number>155</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">155</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Katagi,
T.</author></authors></contributors><titles><title>Photodegradation of
the pyrethroid insecticide esfenvalerate on soil, clay minerals, and
humic acid surfaces</title><secondary-title>Journal of Agricultural and
Food Chemistry
</secondary-title></titles><periodical><full-title>Journal of
Agricultural and Food
Chemistry</full-title></periodical><pages>1351-1356</pages><volume>39</v
olume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year>
1991</year></dates><label>fate</label><urls></urls></record></Cite></End
Note> (Katagi, 1991) ,   ADDIN EN.CITE
<EndNote><Cite><Author>Katagi</Author><Year>1993</Year><RecNum>154</RecN
um><DisplayText>(Katagi,
1993)</DisplayText><record><rec-number>154</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">154</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Katagi,
T.</author></authors></contributors><titles><title>Photodegradation of
esfenvalerate in clay suspensions</title><secondary-title>Journal of
Agricultural and Food
Chemistry</secondary-title></titles><periodical><full-title>Journal of
Agricultural and Food
Chemistry</full-title></periodical><pages>2178-2183</pages><volume>41</v
olume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year>
1993</year></dates><label>fate</label><urls></urls></record></Cite></End
Note> (Katagi, 1993) 	Acceptable (3/6/1991)

Screened

Aerobic Soil Metabolism	T1/2=  75 days in silt loam soil, SS-isomer3

Reported range of 15 – 546 days in literature with an average of 107
days	CO2,
4’’-chloro-(2’’’-isopropyl)phenylaceto-2-(3’-hydroxyphenoxy)
phenylacetonitrile, alpha-carbamoyl-3-phenoxybenzyl
2-(4-chlorophenyl)-3-methylbutyrate 3-phenoxybenzoic acid, and
4-(hydroxyphenoxy)benzoic acid

	00146578, Lee et al. 1985

Open Lit.,   ADDIN EN.CITE
<EndNote><Cite><Author>Laskowski</Author><Year>2002</Year><RecNum>157</R
ecNum><DisplayText>(Laskowski,
2002)</DisplayText><record><rec-number>157</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">157</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Laskowski,
D.A.</author></authors></contributors><titles><title>Physical and
chemical properties of pyrethroids</title><secondary-title>Reviews of
Environmental Contamination and
Toxicology</secondary-title></titles><periodical><full-title>Reviews of
Environmental Contamination and
Toxicology</full-title></periodical><pages>49-170</pages><volume>174</vo
lume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year>2
002</year></dates><label>fate</label><urls></urls></record></Cite></EndN
ote> (Laskowski, 2002) 	Acceptable (11/29/1994)

Screened

Anaerobic Soil Metabolism	T1/2 =  77 days in sandy loam, SS-isomer3

Reported range of 104 -203 days with an average of 154 days	CO2,
4’’-Chloro-(2’’’-isopropyl)phenylaceto-2-(3’-hydroxyphenoxy)
phenylacetonitrile,
4’’-chloro-(2’’’-isopropyl)phenylaceto-2-(3’-phenoxy)phenyla
cetamide, 3-phenoxybenzoic acid, and 4-(hydroxyphenoxy)benzoic acid
42396801 Gaddamidi et al. 1992

Open Lit.,   ADDIN EN.CITE
<EndNote><Cite><Author>Kelley</Author><Year>2003</Year><RecNum>11</RecNu
m><DisplayText>(Kelley,
2003)</DisplayText><record><rec-number>11</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">11</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">371</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Kelley,
Kevin</author></authors></contributors><titles><title>Environmental Fate
of Esfenvalerate</title><tertiary-title>Environmental Monitoring Branch.
 Department of Pesticide Regulation.  California Environmental
Protection
Agency</tertiary-title></titles><dates><year>2003</year></dates><urls><r
elated-urls><url>http://www.cdpr.ca.gov/docs/emon/pubs/fatememo/esfen.pd
f</url></related-urls></urls><access-date>June 19,
2009</access-date></record></Cite></EndNote> (Kelley, 2003) 

	Acceptable (3/30/1993)

Screened

Anaerobic Aquatic Metabolism	Not available	Not available

Aerobic Aquatic Metabolism	Not available	Not available

Kd-ads / Kd-des  (mL/g)

Koc- ads / Koc-des (mL/g)

KOM (mL/g)	600, 700, 750, 1,700, 5,200, 15,500 (sandy loam, sandy clay
loam, silt loam, loam, loamy sand, silt clay loam)

85,700, 140,000, 141,700, 171,700, 375,000, 596,200 (sandy loam, sandy
clay loam,  loam, loamy sand, silt loam, silt clay loam)

50,000, 77,800, 85,000, 101,000, 187,500, 352,300 (sandy loam, sandy
clay loam,  loam, loamy sand, silt loam, silt clay loam)	Not applicable

Not applicable

Not applicable	45555102

Ohm 2001

	Not Reviewed

Terrestrial Field Dissipation	T1/2 = 14 days in sandy loam/sandy clay
loam, Isomer information was not specified	Not reported	41728502 Castle
et al. 1990 and supplement	Acceptable (7/27/1992)

Aquatic Field Dissipation	Not available	Not available

Bioconcen-tration Factor	334-3650 Carp, All isomers	Metabolites included
glucuronide of 4’-OH-fenvalerate, CPIA, 4’-OH-fenvalerate, and
sulfate of 4’-OH-PB acid	42922401 Oshima et al. 1993

42170501 Oshima et al. 1991	Acceptable (11/29/1994)

1 Cyano-3-phenoxybenzyl-2-(4-chlorophyl)-3-methylbutyrate has four
different isomers.  All fate studies were conducted using the SS-isomer
but the rate data may apply to the SS-isomer or total isomers as the
SS-isomer may undergo isomerization.  If the SS-isomer is listed the
data was specific to the SS-isomer.  If all isomers is listed, then the
rate data is specific to total isomers.  

2  Open literature (lit.) indicates the study was obtained from the open
literature and the study was not submitted to the EPA for review. 

3  Limited information was available on the various isomers in the
study.  However, the value was reported as specific to esfenvalerate or
the SS-isomer.  

Transport 

Potential transport mechanisms include pesticide surface water runoff,
spray drift, and secondary drift of soil-bound residues leading to
deposition onto nearby or more distant ecosystems.  Surface water runoff
and spray drift are expected to be the major routes of exposure for
esfenvalerate. Because of its high tendency to sorb to soil (as
evidenced by high Kd/KOC values reported in Table 3-5), esfenvalerate is
expected to reach water bodies primarily sorbed to sediment. With its
persistence, esfenvalerate may accumulate in sediment, where it may be a
reservoir for exposure for benthic organisms   Esfenvalerate is not
persistent in the atmosphere and is not expected to move via long range
transport processes.

Based on its vapor pressure (approximately 0.063 mPa and estimated
Henry’s Law constant (greater than 1.87 Pa-m3/mol), esfenvalerate is
not likely to volatize at environmental temperatures (Comb 2002, MRID
467253-04).  Esfenvalerate is not expected to persist in air due to its
susceptibility to photo-oxidation in air (European Commission, 2005;
Comb, 2002, MRID 467253-04). Based on the short half-life, it is not
expected to undergo long range transport.  

Esfenvalerate is not very soluble (0.002 - <0.01 mg/L) and is
hydrophobic (reported log KOWs range from 5.62 to greater than 6.24)
(Laskowski 2002; European Commission 2005; Comb 2002, MRID 467253-03). 
It is likely to sorb onto organic matter or suspended particles in the
water column and in sediments (log KOCs range from 4.93 to 5.8 mL/g)
(Ohm 2001, MRID 45555102). Based on a leaching study and high KOWs, Kds,
and KOMs, esfenvalerate is unlikely to leach into ground water   ADDIN
EN.CITE   ADDIN EN.CITE.DATA   (Houston, 1978; MRID 42350201, 1992; MRID
45555102, 2001) .

Field Studies

A field soil dissipation study measured a half-life of 7 to 14 days
after a single surface application (0.5 lb/acre) to sandy loam to sandy
clay loam soil from Madera, CA (Castle et al. 1990, MRID 41728502), but
may not have accounted for the fraction sorbed to soil. The European
Commission (2005) estimated field dissipation half-lives of 62-126 days
for a summer application and 68 – 87 days from an autumn application
of esfenvalerate to bare sandy silt loam soil.  Field dissipation
studies measure degradation in the field and allow for many types of
degradation while anaerobic and aerobic degradation are specific to one
type of degradation.  Many variables could contribute to the different
rates measured; however, we speculate that sunlight and irrigation
contributed to the high rate of degradation in the Castle et al. (1990,
MRID 41728502) study.  It is also possible that esfenvalerate sorbed
onto soil and organic particles and remained resistant to analytical
extraction methods used.

Another field study examined the distribution of esfenvalerate after
application directly to a pond.  Samsoe-Petersen et al. (2001) sprayed
esfenvalerate directly onto a pond (0.022 lb ai/acre, near the highest
recommended field dose in Denmark) and measured concentrations in the
surface microlayer, water column, and sediment fractions.  Two weeks
after application, the highest concentrations were found in sediment (9
g/kg), with lower concentrations found on the surface microlayer (0.4
g/L) and in the water column (0.05 g/L)   ADDIN EN.CITE
<EndNote><Cite><Author>Samsoe-Peterson</Author><Year>2001</Year><RecNum>
159</RecNum><DisplayText>(Samsoe-Peterson<style face="italic"> et
al.</style>,
2001)</DisplayText><record><rec-number>159</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">159</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Samsoe-Peterson,
L.</author><author>Gustavsan K.</author><author>Madsen,
T</author><author>Mogensen, B.B.</author><author>Lassen,
K.</author><author>Skjernov, K.</author><author>Christoffersen,
K.</author><author>Jorgensen,
E.</author></authors></contributors><titles><title>Fate and effects of
esfenvalerate in agricultural
ponds</title><secondary-title>Environmental Toxicology and
Chemistry</secondary-title></titles><periodical><full-title>Environmenta
l Toxicology and
Chemistry</full-title></periodical><pages>1570-1578</pages><volume>20</v
olume><number>7</number><keywords><keyword>Esfenvalerate</keyword></keyw
ords><dates><year>2001</year></dates><label>fate,
effects</label><urls></urls></record></Cite></EndNote> (Samsoe-Peterson
et al., 2001) .  Percentages of the total amount applied in each
compartment were not provided.  

Water Monitoring Data

The Agency found no monitoring data for esfenvalerate in either surface
water or ground water in its previous drinking water assessments. 
Esfenvalerate has been removed from the United States Geological Survey
(USGS) National Water-Quality Assessment Program (NAWQA) analytical
methods because of poor recovery during analysis.  

Esfenvalerate was included in surface water and sediment monitoring data
obtained from the California Department of Pesticide Regulation (CDPR).
Esfenvalerate was detected in 3 of 365 surface water samples (0.8%
detections) where the limits of quantification ranged from 0.02 to 0.05
µg/L. The detections – 0.06, 0.14, and 0.17 µg/L – all occurred in
Stanislaus County in 2003. The two highest detections occurred in
tributaries of the San Joaquin River while the lowest detection was
found in an irrigation distribution drain. Esfenvalerate was also
detected in 21 out of 259 sediment samples (8% detections), with limits
of quantification from 0.001 to 0.01 µg/g (ppm). The detections,
ranging from 0.002 to 0.07 µg/g, or 20 to 70 ng/g (ppb), were reported
in Imperial (2 detects), Monterey (5 detects), Placer (5 detects), and
Stanislaus (9 detects) counties between 2003 and 2005. 

Weston et al. (2004) evaluated sediment samples from the Central Valley
of California, with a focus on the pyrethroid insecticides.
Esfenvalerate was detected in 32% of 70 sediment samples collected from
10 counties in the Central Valley, with the highest detections ranging
from 11 to 30 ng/g (0.01 to 0.03 ppb) in three sampled creeks and
sloughs and from 10 to 28 ng/g (0.01 to 0.028 ppb) in three irrigation
canals   ADDIN EN.CITE
<EndNote><Cite><Author>Weston</Author><Year>2004</Year><RecNum>165</RecN
um><DisplayText>(Weston<style face="italic"> et al.</style>,
2004)</DisplayText><record><rec-number>165</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">165</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Weston,
D.P.</author><author>You, J.</author><author>Lydy,
M.J.</author></authors></contributors><titles><title>Distribution and
toxicity of sediment-associated pesticides in agriculture-dominated
water bodies of California’s Central
Valley</title><secondary-title>Environmental Science and
Technology</secondary-title></titles><periodical><full-title>Environment
al Science and
Technology</full-title></periodical><pages>2752-2759</pages><volume>38</
volume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year
>2004</year></dates><label>fate</label><urls></urls></record></Cite></En
dNote> (Weston et al., 2004) .   

Bioaccumulation

Daily bioconcentration factors (BCF) for total isomer residues ranged
from 334-3650 in carp (Cyprinus carpio) exposed to 0.046 – 0.061 parts
per billion esfenvalerate (Oshima et al. 1991, MRID 42922401; Oshima et
al. 1993, MRID 42922401).  Approximately 70% of accumulated residues
were eliminated during the 14-day depuration period, resulting in an
estimated half-life of 7-8 days.  The metabolic pathways were oxidation
of the 4’ position of the alcohol moiety and the 3 position of the
acid moiety, cleavage of the ester linkage, and conjugation of the
resultant phenol and acid with glucuronic acid or sulfuric acid.  The
major metabolites were the glucuronide of 4’-OH-fenvalerate,
4’-OH-fenvalerate, sulfate of 4’-OH-PB acid, and CPIA (Oshima et al.
1991, MRID 42170501).  

When metabolism, growth dilution, and other confounding factors are
ignored, bioconcentration factors are expected to increase with
increasing log KOWs (for log KOW up to ~ 6)   ADDIN EN.CITE
<EndNote><Cite><Author>Gobas</Author><Year>2000</Year><RecNum>127</RecNu
m><DisplayText>(Bintein<style face="italic"> et al.</style>, 1993; Gobas
and Morrison,
2000)</DisplayText><record><rec-number>127</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">127</key></foreign-keys><re
f-type name="Book
Section">5</ref-type><contributors><authors><author>Gobas, Frank
A.P.C.</author><author>Morrison,
H.A.</author></authors><secondary-authors><author>Boethling,
S.R.</author><author>Mackay,
D.</author></secondary-authors></contributors><titles><title>Bioconcentr
ation and Biomagnification in the Aquatic
Environment</title><secondary-title>Handbook of Property Estimation
Methods for
Chemicals</secondary-title></titles><pages>189-227</pages><keywords><key
word>Bioconcentration</keyword></keywords><dates><year>2000</year></date
s><pub-location>Boca Raton</pub-location><publisher>Lewis
Publishers</publisher><urls></urls></record></Cite><Cite><Author>Bintein
</Author><Year>1993</Year><RecNum>128</RecNum><record><rec-number>128</r
ec-number><foreign-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">128</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Bintein,
S.</author><author>Devillers, J.</author><author>Karcher,
W.</author></authors></contributors><titles><title>Nonlinear dependence
of fish bioconcentration on n-Octanol/water partition
coefficients</title><secondary-title>SAR and QSAR in Env.
Res</secondary-title></titles><periodical><full-title>SAR and QSAR in
Env.
Res</full-title></periodical><pages>29-39</pages><volume>1</volume><keyw
ords><keyword>Bioconcentration</keyword></keywords><dates><year>1993</ye
ar></dates><urls></urls></record></Cite></EndNote> (Bintein et al.,
1993; Gobas and Morrison, 2000) .  Using the relationship published by
Mackay between KOW and BCF, results in a predicted BCF of 48000 or log
BCF of 4.68 for esfenvalerate   ADDIN EN.CITE
<EndNote><Cite><Author>Gobas</Author><Year>2000</Year><RecNum>127</RecNu
m><DisplayText>(Gobas and Morrison,
2000)</DisplayText><record><rec-number>127</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">127</key></foreign-keys><re
f-type name="Book
Section">5</ref-type><contributors><authors><author>Gobas, Frank
A.P.C.</author><author>Morrison,
H.A.</author></authors><secondary-authors><author>Boethling,
S.R.</author><author>Mackay,
D.</author></secondary-authors></contributors><titles><title>Bioconcentr
ation and Biomagnification in the Aquatic
Environment</title><secondary-title>Handbook of Property Estimation
Methods for
Chemicals</secondary-title></titles><pages>189-227</pages><keywords><key
word>Bioconcentration</keyword></keywords><dates><year>2000</year></date
s><pub-location>Boca Raton</pub-location><publisher>Lewis
Publishers</publisher><urls></urls></record></Cite></EndNote> (Gobas and
Morrison, 2000) .  This indicates that esfenvalerate has a high
potential to bioconcentrate in organisms.  However, measured BCFs for
carp are much lower than predicted and significant bioconcentration is
not expected to occur in organisms that readily metabolize pyrethroids,
such as mammals and birds.  Mammals and birds tend to metabolize
pyrethroids while insects are more susceptible to toxicity and
bioconcentration because of less developed metabolic systems   ADDIN
EN.CITE
<EndNote><Cite><Author>Eisler</Author><Year>1992</Year><RecNum>32</RecNu
m><DisplayText>(Eisler,
1992)</DisplayText><record><rec-number>32</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">32</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">391</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Eisler,
R.</author></authors></contributors><titles><title>Fenvalerate Hazards
to Fish, Wildlife, and Invertebrates:  A Synoptic Review. Biological
Report No 85(2)</title><tertiary-title>United States Fish and Wildlife
Service
(USFWS)</tertiary-title></titles><dates><year>1992</year></dates><pub-lo
cation>Washington, D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.pwrc.usgs.gov/info
base/eisler/CHR_24_Fenvalerate.pdf</url></related-urls></urls><access-da
te>June 19, 2009</access-date></record></Cite></EndNote> (Eisler, 1992)
.  The ability of fish to metabolize pyrethroids varies.  For example,
carp are known to have a well developed esterase metabolism that will
metabolize esfenvalerate, thus reducing its bioconcentration and
toxicity   ADDIN EN.CITE
<EndNote><Cite><Author>Adelsbach</Author><Year>2003</Year><RecNum>33</Re
cNum><DisplayText>(Adelsbach and Tjeerdema,
2003)</DisplayText><record><rec-number>33</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">33</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">392</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Adelsbach,
T.L.</author><author>Tjeerdema,
R.S.</author></authors></contributors><titles><title>Chemistry of
fenvalerate and esfenvalerate</title><secondary-title>Reviews of
Environmental Contamination and
Toxicology</secondary-title></titles><periodical><full-title>Reviews of
Environmental Contamination and
Toxicology</full-title></periodical><pages>137-154</pages><volume>176</v
olume><dates><year>2003</year></dates><urls></urls></record></Cite></End
Note> (Adelsbach and Tjeerdema, 2003) .  On the other hand, rainbow
trout are known to have decreased rates of metabolism and low rates of
esterase activity for pyrethroids; they are more susceptible to toxicity
and bioconcentration of esfenvalerate   ADDIN EN.CITE
<EndNote><Cite><Author>Adelsbach</Author><Year>2003</Year><RecNum>33</Re
cNum><DisplayText>(Adelsbach and Tjeerdema,
2003)</DisplayText><record><rec-number>33</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">33</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">392</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Adelsbach,
T.L.</author><author>Tjeerdema,
R.S.</author></authors></contributors><titles><title>Chemistry of
fenvalerate and esfenvalerate</title><secondary-title>Reviews of
Environmental Contamination and
Toxicology</secondary-title></titles><periodical><full-title>Reviews of
Environmental Contamination and
Toxicology</full-title></periodical><pages>137-154</pages><volume>176</v
olume><dates><year>2003</year></dates><urls></urls></record></Cite></End
Note> (Adelsbach and Tjeerdema, 2003) .  Amphibians in later
developmental stages may have a more developed metabolic system than
their younger counterparts and amphibians in developmental stages can be
more susceptible to xenobiotic toxicity   ADDIN EN.CITE
<EndNote><Cite><Author>Greulich</Author><Year>2003</Year><RecNum>129</Re
cNum><DisplayText>(Greulich and Pflugmacher,
2003)</DisplayText><record><rec-number>129</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">129</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Greulich,
K.</author><author>Pflugmacher,
S.</author></authors></contributors><titles><title>Differences in
susceptibility of various life stages of amphibians to pesticide
exposure</title><secondary-title>Aquatic
Toxicology</secondary-title></titles><periodical><full-title>Aquatic
Toxicology</full-title></periodical><pages>329-336</pages><volume>65</vo
lume><keywords><keyword>Bioconcentration</keyword></keywords><dates><yea
r>2003</year></dates><urls></urls></record></Cite></EndNote> (Greulich
and Pflugmacher, 2003) . 

Receptors

The receptor is the biological entity that is exposed to the stressor  
ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>1998</Year><RecNum>13</RecNum
><DisplayText>(USEPA,
1998)</DisplayText><record><rec-number>13</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">13</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">373</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Guidelines for Ecological Risk
Assessment</title><secondary-title>United States Environmental
Protection Agency (USEPA)</secondary-title><tertiary-title>Risk
Assessment Forum.  Office of Research and
Development</tertiary-title></titles><number>EPA/630/R-95/002F</number><
dates><year>1998</year><pub-dates><date>April,
1998</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://cfpub.epa.gov/ncea/cfm
/recordisplay.cfm?deid=12460</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 1998) . 
Consistent with the process described in the Overview Document   ADDIN
EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2004</Year><RecNum>16</RecNum
><DisplayText>(USEPA,
2004)</DisplayText><record><rec-number>16</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">16</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">376</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Overview of the Ecological Risk
Assessment Process in the Office of Pesticide
Programs</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>Environmental Fate and
Effects Division.  Office of Pesticide
Programs.</tertiary-title></titles><dates><year>2004</year><pub-dates><d
ate>January 23, 2004</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.epa.gov/espp/consu
ltation/ecorisk-overview.pdf</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 2004) , the
risk assessment for esfenvalerate relies on a surrogate species
approach.  T  SEQ CHAPTER \h \r 1 oxicological data generated from
surrogate test species, which are intended to be representative of broad
taxonomic groups, are used to extrapolate to potential effects on a
variety of species (receptors) included under these taxonomic groupings.
 

Acute and chronic toxicity data from studies submitted by pesticide
registrants along with the available open literature are used to
evaluate the potential direct and indirect effects of esfenvalerate to
aquatic and terrestrial receptors. This includes toxicity on the
technical grade active ingredient, degradates, and when available,
formulated products (e.g., “Six-Pack” studies).  The open literature
studies are identified through EPA’s ECOTOXicology (ECOTOX) database  
ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2009</Year><RecNum>19</RecNum
><DisplayText>(USEPA,
2009b)</DisplayText><record><rec-number>19</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">19</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">379</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>ECOTOXicology
Database</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>National Health and
Environmental Effects Research Laboratory&apos;s Mid-Continent Ecology
Division).Office of Research and
Development.</tertiary-title></titles><dates><year>2009</year></dates><u
rls><related-urls><url>http://cfpub.epa.gov/ecotox/</url></related-urls>
</urls><access-date>June 19,
2009</access-date></record></Cite></EndNote> (USEPA, 2009b) , which
employs a literature search engine for locating chemical toxicity data
for aquatic life, terrestrial plants, and wildlife.  The evaluation of
both sources of data may also provide insight into the direct and
indirect effects of esfenvalerate on biotic communities from loss of
species that are sensitive to the chemical and from changes in structure
and functional characteristics of the affected communities.  Open
literature data from ECOTOX on esfenvalerate was searched on February
28, 2009.  The data is being evaluated for possible quantitative and/or
qualitative inclusion in the risk assessment.    

A summary of the aquatic and terrestrial toxicity data used to derive a
preliminary evaluation of risk for esfenvalerate is provided in Sections
4.1 and 4.2, respectively.  In addition, a summary of ecological
incidents associated with esfenvalerate and a description of ecosystems
potentially at risk are provided in Sections 4.3 and 4.4, respectively.

Effects to Aquatic Organisms

Information on the toxicity of esfenvalerate to selected taxa is
characterized based on registrant-submitted studies and a comprehensive
review of the open literature on esfenvalerate (primarily SS
stereoisomer) and the sterioisomeric related compound fenvalerate
(approximately equal mixture of RR, RS, SR, and SS).  Esfenvalerate
contains more of the insecticidally active isomer; however, some
fenvalerate toxicity endpoints are lower than esfenvalerate endpoints
for other taxa.  Ultimately, organisms exposed to esfenvalerate in water
are exposed to a mixture of isomers because esfenvalerate
sterioisomerizes in water (MRID 40999303).  Therefore, fenvalerate
toxicity endpoints that are more sensitive than that of esfenvalerate
will be utilized in the risk assessment where applicable.  

A summary of sensitive aquatic toxicity data from registrant-submitted
studies and data available from the ECOTOX database is provided in   REF
_Ref225325574 \h  \* MERGEFORMAT  Table 4-1 .    REF _Ref213563188 \h 
\* MERGEFORMAT  Appendix B  includes a table summarizing toxicity data
submitted to the Agency.  Esfenvalerate is classified as very highly
toxic to aquatic organisms based on data for aquatic vertebrates and
invertebrates.  Sublethal effects such as erratic swimming, gasping for
air, lying on the bottom, lethargy, rapid respiration, vertical
position, loss of equilibrium, and dark coloration were observed in both
vertebrate and invertebrate studies and in some studies at all treatment
levels.  

Measured concentrations in static tests indicated that the test levels
were not constant (e.g., within 20% of initial measured concentrations).
 Aquatic toxicity values from static tests and conducted using the
Technical Grade Active Ingredient (TGAI) without measured concentrations
should be considered supplemental-qualitative because the exposure
concentration is not known   ADDIN EN.CITE
<EndNote><Cite><Author>Rabert</Author><Year>1995</Year><RecNum>110</RecN
um><DisplayText>(Rabert<style face="italic"> et al.</style>,
1995a)</DisplayText><record><rec-number>110</rec-number><foreign-keys><k
ey app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">110</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">585</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Rabert,
William</author><author>Craven, Harry</author><author>Maciorowski,
Anthony F.</author></authors></contributors><titles><title>Ecological
Effects Branch Review of Esfenvalerate Use on Grain
Sorghum</title><secondary-title>September 15,
1955</secondary-title><tertiary-title>Ecological Effects Branch. 
Environmental Fate and Effects Division.  Office of Pesticide Programs. 
United States Environmental Protection
Agency</tertiary-title></titles><keywords><keyword>Esfenvalerate</keywor
d></keywords><dates><year>1995</year><pub-dates><date>September 15,
1995</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rabert et
al., 1995a) .  Static acute studies conducted with the Typical End-Use
Product (TEP) without measured concentrations may be use to assess
exposure to spray drift only and only reflect potential effects from a
brief exposure to the formulation. 

Freshwater Fish

All acute studies submitted for freshwater fish using the TGAI were
static tests and when concentrations were measured they were highly
variable.  Therefore, these studies are considered supplemental.  The
data available are not quantitative and therefore, the toxicity of the
formulation compared to the TGAI cannot be evaluated for freshwater
fish.  No acceptable chronic toxicity studies were submitted for fish. 
Several studies are available in the open literature.  The open
literature studies will be evaluated for possible use in the risk
assessment.   

Freshwater Invertebrates

The studies available on the water flea suggest that the racemic mixture
is more toxic than the SS-isomer (the 48-hr LC50 for all isomers was
0.049 and it was 0.24 µg/L for a mixture of mainly the SS-isomer) (MRID
41891914 and 42492602).  In a chronic toxicity test with the TGAI and
ss-isomer, a decreased total number of young was observed at 0.079 µg/L
(NOAEL = 0.052 µg/L) and mortality was observed at 0.45 µg/L (NOAEL =
0.15 µg/L).  The mortality endpoint in the chronic study is higher than
the 48-hr LC50 values, leading to uncertainty in the acceptability of
the chronic study which was conducted in a static system with measured
concentrations.

Estuarine/marine Fish and Invertebrates

The source of data for estuarine/marine fish are studies on pesticides
compiled by the USEPA   ADDIN EN.CITE
<EndNote><Cite><Author>40228401</Author><Year>1986</Year><RecNum>121</Re
cNum><DisplayText>(MRID 40228401,
1986)</DisplayText><record><rec-number>121</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">121</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
40228401,</author></authors><secondary-authors><author>Mayer, F.
L.</author></secondary-authors></contributors><titles><title>Acute
Toxicity Handbook of Chemicals to Estuarine
Organisms</title></titles><volume>288</volume><number>EPA/600/X-86/231</
number><dates><year>1986</year></dates><pub-location>Environmental
Research Laboratory, Office of Research and Development, United States
Environmental Protection Agency.  Gulf Breeze, FL. 
</pub-location><urls></urls></record></Cite></EndNote> (MRID 40228401,
1986) .  The raw data for these studies are not available and many of
the details of the studies are not known. The studies were conducted for
the racemic mixture.  No toxicity tests with esfenvalerate (e.g., the
SS-isomer) are available for estuarine/marine organisms.  Additionally,
no aquatic chronic testing was completed for fenvalerate or
esfenvalerate for estuarine/marine fish and invertebrates.  A 28-day
sediment study on the amphipod is available and is currently under
review (MRID 46620401).

Aquatic Plants

Open literature studies are available on the toxicity of fenvalerate to
alga.  The species tested include Isochrysis galbana, Skeletonema
costatum, Thalassioxira pseudonana, and Nitzsichia angularus   ADDIN
EN.CITE
<EndNote><Cite><Author>40228401</Author><Year>1986</Year><RecNum>121</Re
cNum><DisplayText>(MRID 40228401,
1986)</DisplayText><record><rec-number>121</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">121</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
40228401,</author></authors><secondary-authors><author>Mayer, F.
L.</author></secondary-authors></contributors><titles><title>Acute
Toxicity Handbook of Chemicals to Estuarine
Organisms</title></titles><volume>288</volume><number>EPA/600/X-86/231</
number><dates><year>1986</year></dates><pub-location>Environmental
Research Laboratory, Office of Research and Development, United States
Environmental Protection Agency.  Gulf Breeze, FL. 
</pub-location><urls></urls></record></Cite></EndNote> (MRID 40228401,
1986) .  All endpoints were reported to be greater than 1000 µg/L  
ADDIN EN.CITE
<EndNote><Cite><Author>40228401</Author><Year>1986</Year><RecNum>121</Re
cNum><DisplayText>(MRID 40228401,
1986)</DisplayText><record><rec-number>121</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">121</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
40228401,</author></authors><secondary-authors><author>Mayer, F.
L.</author></secondary-authors></contributors><titles><title>Acute
Toxicity Handbook of Chemicals to Estuarine
Organisms</title></titles><volume>288</volume><number>EPA/600/X-86/231</
number><dates><year>1986</year></dates><pub-location>Environmental
Research Laboratory, Office of Research and Development, United States
Environmental Protection Agency.  Gulf Breeze, FL. 
</pub-location><urls></urls></record></Cite></EndNote> (MRID 40228401,
1986) .  This concentration exceeds the solubility of fenvalerate and
nominal test concentrations were reported for static tests.  As little
information is available for these endpoints, the data will only be used
as supplemental data.  Additionally, some studies in the open literature
are available examining toxicity of esfenvalerate to aquatic plants. 
These data will be evaluated for possible use in the risk assessment.

Table   STYLEREF 1 \s  4 -  SEQ Table \* ARABIC \s 1  1 .  Summary of
Sensitive Endpoints for Aquatic Organisms Under Consideration for Use in
the Risk Assessment for Esfenvaleratea

Common Name

(Species)

TGAI /TEP

Isomer

Test parameters	Duration and Endpoint

	 Mean concentration in µg a.i./L 

(95% C.I.)

Slope

 effect	Citation or

MRID/

status or review 	USEPA Acute Toxicity Classification

Freshwater Vertebrates and Aquatic-phase amphibians

Rainbow Trout

(Oncorhynchus mykiss)

TEP (WP)

44% SS, 51% all isomers

Flow-through/measured	96-hr LC50	0.07 (0.06-0.09)

Slope = 7.0 (3.2-10.7)

mortality	43358311

Acceptable	Very Highly Toxic

Bluegill Sunfish

(Lepomis macrochirus)

TEP (WP)

44% SS, 51% all isomers

Flow-through/measured	96-hr LC50	0.23 (0.19-0.30)

Slope = 6.79 (3.29-10.29) (mortality)	43358312

Acceptable	Very Highly Toxic

Fathead Minnow

(Pimephales promeles)

TGAI

98% all isomers

Static/nominal	96-hr LC50	0.18	41215201

Supplemental-qualitative	Very Highly Toxic

Rainbow Trout, Donaldson trout

(Oncorhynchus mykiss)

TGAI

100% all isomers	70-d LC50	0.101	  ADDIN EN.CITE
<EndNote><Cite><Author>Curtis</Author><Year>1985</Year><RecNum>120</RecN
um><DisplayText>(Curtis<style face="italic"> et al.</style>,
1985)</DisplayText><record><rec-number>120</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">120</key></foreign-keys><re
f-type name="Journal
Article">17</ref-type><contributors><authors><author>Curtis,
L.R.</author><author>Seim, W.K.</author><author>Chapman,
G.A.</author></authors></contributors><titles><title>Toxicity of
fenvalerate to developing Steelhead trout following continuous or
intermittent exposure.  ECOTOX Number
12019</title><secondary-title>Journal of Toxicologgy and Environmental
Health</secondary-title></titles><periodical><full-title>Journal of
Toxicologgy and Environmental
Health</full-title></periodical><pages>445-457</pages><volume>15</volume
><dates><year>1985</year></dates><urls></urls></record></Cite></EndNote>
(Curtis et al., 1985) (ECOTOX #12019)b

Not reviewed	--

Estuarine/Marine Vertebrates

Atlantic Silverside

(Menidia beryllina)

TGAI

100% All isomers

Flow Through/measured	96-hr LC50	0.31 (0.21-0.40)

(mortality)

	40228401

Supplemental-qualitative	Very Highly Toxic

Atlantic Silverside

Menidia menidia

TGAI

100% all isomers

Flow-through/measured	96-hr LC50	0.29 (0.21-0.37)

(mortality)

	40228401

Supplemental-qualitative	Very Highly Toxic

Freshwater Invertebrates

Waterflea

(Daphnia magna)

TGAI

83% SS-isomer, 16% All isomers

Static-renewal/nominal	48-hr LC50	0.24

(mortality)	42492602

Supplemental-qualitative	Very Highly Toxic

Waterflea

(Daphnia magna)

TGAI

97.6% All-isomers

Static/measured	48-hr LC50	0.05

(mortality)	41891914

Acceptable	Very Highly Toxic

Water Flea

Daphnia magna

TEP

8.4% SS-isomer

Flow-Through/measured	48-hr LC50	0.008 µg/L

(mortality)

	41798301

Supplemental-qualitatived	Very Highly Toxic

Waterflea

(Daphnia magna)

TGAI

98.6 SS-isomer

Static/measured	Chronic

NOAEL/ LOAEL	0.052/0.079 µg/L

(total number of young)

0.15/0.45 µg/L

(mortality)

	40444001

Acceptable	--

Midge

Chironomus tentans

TGAI

SS-isomer	10-day Sediment Test	No NOEC available	46591505c

Preliminary Supplemental	--

Estuarine Marine Invertebrates

Pink Shrimp

Panaeus duorarum

TGAI

100% all isomers

Flow-through/measured	96-hr LC50	 0.84bc

(mortality)	40228401

Supplemental-qualitative	Very Highly Toxic

Amphipods

Leptocheirus plumulosus	28-day

sediment

46620401

Not reviewed

	TGAI=technical grade active ingredient; TEP=typical end use product;
LC50 = median lethal concentration; NOAEL=no observable adverse effect
level; a.i. active ingredient

a  Data in this table may be used in the risk assessment, but it will
not necessarily be used to calculate risk quotients.  EPA has not
established a toxicity classification system for ecological chronic
toxicity studies.

b  This is the reference number of this study in the ECOTOX database  
ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2009</Year><RecNum>19</RecNum
><DisplayText>(USEPA,
2009b)</DisplayText><record><rec-number>19</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">19</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">379</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>ECOTOXicology
Database</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>National Health and
Environmental Effects Research Laboratory&apos;s Mid-Continent Ecology
Division).Office of Research and
Development.</tertiary-title></titles><dates><year>2009</year></dates><u
rls><related-urls><url>http://cfpub.epa.gov/ecotox/</url></related-urls>
</urls><access-date>June 19,
2009</access-date></record></Cite></EndNote> (USEPA, 2009b) .

c  This study has not been reviewed and will be reviewed before the risk
assessment to determine whether the results may be used in the risk
assessment.  

d Water used in this study may have been contaminated.

Mesocosm Studies

A mesocosm study (MRID 41573901) was submitted to EFED as a rebuttal to
a presumption of hazard to aquatic systems resulting from a worst case
exposure scenario assumed by OPP.  In this study, nine 0.1-hectare ponds
were treated with low, medium, or high doses of esfenvalerate (three
ponds per treatment), and three additional ponds that did not receive
esfenvalerate served as controls. Treatments were meant to simulate
exposure to aquatic systems through both drift and runoff, where 10
drift events and five runoff events were simulated to provide total
esfenvalerate loads of 0, 232.5, 4,125, and 23,270 mg ai/pond for the
control, low, medium, and high treatments, respectively.  Observations
were made on effects to phytoplankton, zooplankton, macro-invertebrate,
and juvenile fish populations occurring within multiple zones (benthic,
littoral, open water) of the ponds throughout the study.  At the end of
the study, additional measurements were made on the relative health of
populations of fish exposed during the study.

Effects on phytoplankton and emergent aquatic vegetation were not
observed.  Significant effects

were not observed on the animal taxa studied in the ponds receiving the
low treatment, but eradication of some insect populations and reductions
in small fish were found in both the medium and high treatment levels.
Adverse effects were apparent almost immediately in aquatic insect
populations.  The most dramatic population reductions in aquatic
invertebrate species were apparent in benthic samples when they were
compared to controls and open-water and littoral samples.  This result
is particularly significant because esfenvalerate residues are expected
to occur predominately in the sediment.

Significant changes in relative health of the fish populations studied
at the end of the experiment were not observed, and the authors
dismissed any long term effects of esfenvalerate on fish populations. 
However, the decline in populations of certain aquatic zooplankton and
macro-invertebrates at times that coincide with fish reproduction will
represent a decrease in a significant food base which will affect fish
larval growth and possibly year-class strength. Furthermore, the
comparative applicability of this study to aquatic environments outside
of the

study area (Alabama) is debatable.  The bioavailability of esfenvalerate
will change with the environmental characteristics.  Finally, changes in
aquatic chemistry during the study (increased

alkalinity and rising pH from supplemental fertilization) may have
influenced the results of the study.

Mesocosm and Field Studies from Open Literature

Bouldin et al. (2004) examined the effect of esfenvalerate on aquatic
invertebrates in an agricultural ditch mesocosm   ADDIN EN.CITE
<EndNote><Cite><Author>Bouldin</Author><Year>2004</Year><RecNum>116</Rec
Num><DisplayText>(Bouldin<style face="italic"> et al.</style>,
2004)</DisplayText><record><rec-number>116</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">116</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">591</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Bouldin,
J.L.</author><author>Milam, C.D.</author><author>Farris,
J.L.</author><author>Moore, M.T.</author><author>Smith Jr.,
S.</author><author>Cooper,
C.M.</author></authors></contributors><titles><title>Evaluating toxicity
of Asana XL (esfenvalerate) amendments in agricultural ditch
mesocosms</title><secondary-title>Chemosphere</secondary-title></titles>
<periodical><full-title>Chemosphere</full-title></periodical><pages>677-
683</pages><volume>56</volume><dates><year>2004</year></dates><urls></ur
ls></record></Cite></EndNote> (Bouldin et al., 2004) .  A storm event
(0.64 cm on a 20.23-ha field) producing runoff with esfenvalerate was
simulated in an agricultural drainage ditch. Aqueous grab samples and a
composite sediment sample from several locations were collected prior to
the application.  Aqueous and sediment samples were then taken after
application at 0.5, 3, and 24 hours and 28 days post application at 0,
20, 80, 200, and 600 meters downstream (also at 56 days for sediment). 
Reference upstream samples were also collected at 10 meters (m). These
were analyzed for esfenvalerate residues and were used in aqueous and
sediment toxicity tests with fish and invertebrates.

Toxicity tests were conducted on an aquatic invertebrate (Ceriodaphnia
dubia) and a fish (Pimphales promelas), and sediment toxicity tests were
conducted with midge (Chironomus

tentans).  The highest concentration of esfenvalerate was detected at
the injection point (0 m) at

3 hours post application.  Survival of C. dubia and P. promelas was 0%
at 0 and 20 m at 0.5 and

3 hours post application.  At 3 hours post application, survival of C.
dubia was 0% at 80 m and

was 17.5 % for P. promelas.  Survival was ≥72.5% for all other times
and distances, with the

exception of C. dubia at 80 m 24 hours post application (45 ± 44%) and
P. promelas at 80 m 28

days post application (60 ± 25.8 %).  Survival and growth of Chironomus
tentans was

significantly lower than control at the injection site only, but at all
sampling times.  Survival was

highest 3 hours post application (25 ±16%) and declined through Day 56
to 6.3 ± 7.4%.

Pesticides were also measured in plant material at 20, 80, 200 and 6000
m from the injection site at 3 hours, 24 hours, 28 days, and 56 days
post application. Concentrations in plant material were highest at 20 m,
3 hours post application (2010.34 ppb) and declined with distance and
time.

The application rate that the runoff event was expected to simulate was
not reported, and likely the amount of esfenvalerate that would reach
surface water via runoff would vary with environmental conditions.  The
water velocity in this study was measured at 0.04 m/s, so it is not

known how these results, especially for sediments, would compare to a
faster moving system.

However, it still provides an indication of the potential effects of
esfenvalerate in an aquatic system.

Pieters et al. (2005) investigated the effects of fenvalerate under
field conditions (including food restriction) on D. magna   ADDIN
EN.CITE
<EndNote><Cite><Author>Bouldin</Author><Year>2004</Year><RecNum>116</Rec
Num><DisplayText>(Bouldin<style face="italic"> et al.</style>,
2004)</DisplayText><record><rec-number>116</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">116</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">591</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Bouldin,
J.L.</author><author>Milam, C.D.</author><author>Farris,
J.L.</author><author>Moore, M.T.</author><author>Smith Jr.,
S.</author><author>Cooper,
C.M.</author></authors></contributors><titles><title>Evaluating toxicity
of Asana XL (esfenvalerate) amendments in agricultural ditch
mesocosms</title><secondary-title>Chemosphere</secondary-title></titles>
<periodical><full-title>Chemosphere</full-title></periodical><pages>677-
683</pages><volume>56</volume><dates><year>2004</year></dates><urls></ur
ls></record></Cite></EndNote> (Bouldin et al., 2004) .  The main goal of
this study was to examine the effects of low food conditions on life
history characteristics of Daphnia magna, especially the intrinsic rate
of increase, during pulses of pesticide exposure.  Fenvalerate was used
as a model pesticide, but the study does provide some information on the
effects of this pesticide under field conditions.  D. magna were exposed
to control, 0.03, 0.1, 0.3, 0.6, 1.0, and 3.2 ppb fenvalerate
concentrations (nominal) for 24 hours under two different feeding
regimes (low and high).  The effect on the intrinsic rate of increase
was measured over the course of 21 days post-exposure. Under both food
levels, the highest concentration caused 100% mortality by Day 8
post-exposure, and most mortality in all groups was complete by this
day.  In the high food group, mortality did not exceed 35% in any test
concentration group, whereas in the low food group mortality was higher
in all test concentrations above 0.1 ppb.  Low food conditions
significantly increased age at first reproduction and decreased mean
brood number, mean brood size, and cumulative reproduction per living
female by the end of the test (Day 21).  As a result, the intrinsic rate
of increase was significantly lower in the low food concentration test
groups, indicating that greater detrimental population effects would be
expected under these conditions.

Effects to Terrestrial Organisms

A summary of sensitive terrestrial toxicity data from
registrant-submitted studies and data available from the ECOTOX database
is provided in   REF _Ref227396999 \h  \* MERGEFORMAT  Table 4-2 .   
REF _Ref213563188 \h  \* MERGEFORMAT  Appendix B  includes a table
summarizing toxicity data submitted to the Agency.  Based on the
available data, esfenvalerate is classified as practically nontoxic to
moderately toxic to birds, moderately toxic to mammals, and highly toxic
to terrestrial invertebrates.  All endpoints are provided in terms of
the active ingredient (ai) unless otherwise specified.

Mammals

Acute, subchronic, and chronic toxicity studies are available for
mammals.  These results are fully discussed in Doherty 2004   ADDIN
EN.CITE
<EndNote><Cite><Author>Doherty</Author><Year>2004</Year><RecNum>114</Rec
Num><DisplayText>(Doherty,
2004)</DisplayText><record><rec-number>114</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">114</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">589</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Doherty,
John</author></authors><secondary-authors><author>TXR # 0051089.  DP
Barcode Number
D279636</author></secondary-authors></contributors><titles><title>Toxico
logy Disciplinary Chapter for the Reregistration Eligibility Decision
Document</title><secondary-title>August 23,
2004</secondary-title><tertiary-title>Health Effects Division.  Office
of Pesticide Programs. 
</tertiary-title></titles><keywords><keyword>esfenvalerate</keyword></ke
ywords><dates><year>2004</year><pub-dates><date>August 23,
2004</date></pub-dates></dates><label>HED risk
assessment</label><urls></urls></record></Cite></EndNote> (Doherty,
2004) .  In acute studies, esfenvalerate was shown to be moderately
toxic.  Subchronic studies resulted in decreased body weight, decreased
motor activity, and decreased hindlimb strength.  In a chronic study
with dogs neurotoxicity was observed demonstrated with emisis, head
shaking, and biting extremities.  Systemic effects included normocytic
anemia, increased serum cholesterol, and possible hepatic
microglanulomatosis.  Observations in mice include weight loss, anemia,
reactive responses in the lymphatic tissue, hepatic granuloma, and giant
cell formulation in the liver and spleen.  In developmental studies,
developmental toxicity was not observed at dose levels at or below
maternal toxicity and the rat multigeneration study did not indicate
adverse effects on reproductive performance.  At the highest dose, the
F1 generation could not tolerate the same dose as the P generation and
demonstrated abnormal gait, tremors, ataxia, hyperactivity,
vocalizations, hypersensitivity, and eventual death even after lowering
the dose.  There is no evidence of carcinogenicity.  The tolerances for
humans are based on toxicity data for esfenvalerate.  Not enough
information is available to compare the toxicity of the formulations to
esfenvalerate alone because confidence intervals overlap or are not
available; however, preliminary results indicate that formulations are
more toxic and open literature information on the
syngergism/potentiation of piperonyl butoxide and MGK for pyrethroids
indicates that it is likely that formulations containing these active
ingredients are more toxic to mammals.

Birds

Acute avian studies indicate that esfenvalerate is moderately toxic to
birds (  REF _Ref227396999 \h  \* MERGEFORMAT  Table 4-2 ).  Sublethal
effects observed include: ruffled appearance, lower limb weakness,
muscular fasciculations, hyper-excitability, loss of coordination,
depression, and reduced reaction to external stimuli, reduction in food
consumption, agitation, reduced body weight, excessive scratching,
lethargy, prostate posture, convulsions, wing drop, reduced reaction to
sound and movement, and head twitching (  REF _Ref213563188 \h  \*
MERGEFORMAT  Appendix B ).  Many birds recovered over time.  Acute oral
studies indicated that the SS-isomer was more toxic than all isomers. 
The acute oral LD50s for the bobwhite quail were 381 mg/kg-bw for the
SS-isomer and >2000 mg/kg-bw for all isomers (MRID 41698401 and
41891909).  This indicates that data are needed for the SS-isomer and
toxicity tests for all isomers should not be used to evaluate risk for
birds.  On the other hand, subacute dietary studies on birds indicate
that the SS-isomer and all isomers have similar toxicity (  REF
_Ref213563188 \h  \* MERGEFORMAT  Appendix B ).  Complete studies on the
reproductive toxicity of esfenvalerate to birds are not available as
test concentrations in the field are expected to exceed those tested in
the lab; however, available supplemental studies indicate that cracked
eggs may occur with exposure to esfenvalerate (MRID 37111 and 37112). 
Chronic avian studies are available in the open literature and they will
be evaluated for possible use in the risk assessment.

Terrestrial Invertebrates

Esfenvalerate is classified as highly toxic to honey bees on an acute
contact basis.  Studies with fenvalerate did not provide a more
sensitive endpoint value.

Terrestrial Plants

No terrestrial plant toxicity data were submitted.  Open literature
studies are available and some are summarized here.  A complete analysis
of the open literature studies will be completed when the risk
assessment is performed.  Toscano et al. (1982) found no effects of
fenvalerate on lettuce   ADDIN EN.CITE
<EndNote><Cite><Author>Toscano</Author><Year>1982</Year><RecNum>117</Rec
Num><DisplayText>(Toscano<style face="italic"> et al.</style>,
1982)</DisplayText><record><rec-number>117</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">117</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">592</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Toscano,
N.C.</author><author>Sances, F.V.</author><author>Johnson,
M.W.</author><author>LaPre,
L.F.</author></authors></contributors><titles><title>Effect of various
pesticides on lettuce physiology and yield.  ECOTOX reference #
41092</title><secondary-title>Journal of Economic
Entomology</secondary-title></titles><periodical><full-title>Journal of
Economic
Entomology</full-title></periodical><pages>738-741</pages><volume>75</vo
lume><keywords><keyword>Esfenvalerate</keyword></keywords><dates><year>1
982</year></dates><urls></urls></record></Cite></EndNote> (Toscano et
al., 1982) .  Fenvalerate (2.4 EC) was applied via backpack sprayer at
0.22 kg ai/ha (0.20 lbs ai/ac), and lettuce plants received either one
or two treatments over the course of approximately 1.5 months.  No
difference in growth (measured in mass) was observed between plants
treated with fenvalerate one or two times and the untreated controls.  

In contrast with the above study, two studies did observe detrimental
effects of fenvalerate on plants, though neither provides enough
information to calculate an endpoint that can be used quantitatively. 
Chauhan et al. (1999) tested the dose-response of fenvalerate on onion
root growth and cytogenesis   ADDIN EN.CITE
<EndNote><Cite><Author>Chaugan</Author><Year>1999</Year><RecNum>118</Rec
Num><DisplayText>(Chaugan<style face="italic"> et al.</style>,
1999)</DisplayText><record><rec-number>118</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">118</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">593</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Chaugan,
L.K.S.</author><author>Saxena, P.N.</author><author>Gupta,
S.K.</author></authors></contributors><titles><title><style
face="normal" font="default" size="100%">Cytogenetic effects of
cypermethrin and fenvalerate on the root beristem cells of
</style><style face="italic" font="default" size="100%">Allium cepa. 
</style><style face="normal" font="default" size="100%">ECOTOX Reference
Number 72820</style></title><secondary-title>Environmental and
Experimental
Botany</secondary-title></titles><periodical><full-title>Environmental
and Experimental
Botany</full-title></periodical><pages>181-189</pages><volume>42</volume
><dates><year>1999</year></dates><urls></urls></record></Cite></EndNote>
(Chaugan et al., 1999) .  Onions were grown in test concentrations of
fenvalerate of 7, 14, and 28 ppm for five days, and root growth compared
to the control was determined on the fifth day.  The EC50 was calculated
as the concentration that inhibited growth by 50%, and this was
determined to be 14.25 ppm.  Through examinations of cells at the onion
root tip, the authors concluded that growth reductions were caused by
chromosome and mitosis aberrations.  El-Daly (2006) tested germination
and growth of radishes following exposure to fenvalerate.  Radish seeds
were germinated on moist filter paper containing 1-1000 M concentration
(0.42 – 420 mg/L) of fenvalerate   ADDIN EN.CITE
<EndNote><Cite><Author>El-Daly</Author><Year>2006</Year><RecNum>119</Rec
Num><DisplayText>(El-Daly,
2006)</DisplayText><record><rec-number>119</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">119</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">594</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>El-Daly,
F.A.</author></authors></contributors><titles><title><style
face="normal" font="default" size="100%">Role of fenvalerate
(pyrethroid) and cyanox (organophosphorus) insecticides on growth and
some metabolic activities during seedling growth of </style><style
face="italic" font="default" size="100%">Raphanus sativus
L.</style><style face="normal" font="default" size="100%">.  ECOTOX
Reference Number 93363</style><style face="italic" font="default"
size="100%"> </style></title><secondary-title>Pakistan Journal of
Biological
Sciences</secondary-title></titles><periodical><full-title>Pakistan
Journal of Biological
Sciences</full-title></periodical><pages>2313-2317</pages><volume>9</vol
ume><dates><year>2006</year></dates><urls></urls></record></Cite></EndNo
te> (El-Daly, 2006) .  Germination and plant growth was observed
immediately afterward.  The study noted that with fenvalerate, an
increase in growth was observed in some growth parameters at the lowest
levels, but a decrease was observed at the highest levels.  The authors
also noted a decrease in percent germination, which was also not
dose-dependent. 

Table   STYLEREF 1 \s  4 -  SEQ Table \* ARABIC \s 1  2 .  Summary of
Sensitive Toxicity Endpoints for Terrestrial Organisms Under
Consideration for Use in Risk Assessment*

Common Name

(Species)

TGAI /TEP

Isomer	End-point	Mean Concentration (95% C.I.) and Effect	Citation or

MRID / Status

	Acute Toxicity Classification

Mammals

Laboratory Rat

(Rattus norvegicus)

TGAI 98.8%

SS-isomer	Acute Oral LD50	Estimated*** 59.0 mg/kg-body weight
(0->20,000) (mortality)

	46765601

Acceptable

	Highly Toxic

Laboratory Rat

(Rattus norvegicus)

TGAI 97%

SS-isomer	Acute Oral LD50	

87.2 mg/kg-bw (mortality)	144973

Acceptable	Highly Toxic

Laboratory Rat

(Rattus norvegicus)

TEP

0.425% SS-isomer

0.425% imiprothrin	Acute Oral LD50	Estimated 3129 (1750-5000) mg
product/kg-bw

13 (7-21) mg esfenvalerate/kg-bw (mortality)	46350801

Acceptable	--

Laboratory Rat

(Rattus norvegicus)

TEP

2.5%% SS-isomer

2.5% imithrin

12.5% MGK	Acute Oral LD50	903 mg product/kg-bw

23 mg esfenvalerate/kg-bw (mortality)	45169301

Acceptable	--

Laboratory Rat

(Rattus norvegicus

TGAI 98.8%

♀,♂:  <75 mg/kg/ 75 mg/kg or 4.21 mg/kg/day

(dermal lesions, decreased body weight)

Offspring ♂:  75 mg/kg/ 100 mg/kg  or 5.56/ 7.18 mg/kg/day (decreased
pup weight, decreased litter size, subcutaneous hemorrhage)	43489001

Acceptable

  ADDIN EN.CITE   ADDIN EN.CITE.DATA   (Borges et al., 2008; Doherty,
2004) 	--

Birds**

Bobwhite Quail (Colinus virginianus)

TGAI

SS-isomer	Acute Oral LD50	381 mg/kg-bw (mortality)	41698401

Acceptable	Highly Toxic

Mallard Duck 

(Anas platyrhynchos)

TGAI 98.6

SS-isomer	Subacute Dietary LC50	4894 mg/kg-diet (mortality)	41637802

Acceptable	Slightly Toxic

Terrestrial Invertebrates

Honey Bee

(Apis mellifera)

TGAI 98.6

SS-isomer	48-hr LD50	Acute-contact:  0.017 µg/bee

(mortality)	41698402

Acceptable	Highly Toxic

TGAI=technical grade active ingredient; TEP=typical end use product;
LD50 = median lethal dose; NOAEL=no observable adverse effect level;
a.i. active ingredient; NA = not applicable; bw-body weight

*  Data in this table may be used in the risk assessment, but it will
not necessarily be used to calculate risk quotients.

**Birds represent surrogates for terrestrial-phase amphibians and
reptiles.

*** Two of three mice died at this concentration.

Incident Database Review

In a preliminary review of the Ecological Incident Information System
(EIIS) maintained by the Agency’s Office of Pesticide Programs (OPP) a
total of 12 reported ecological incidents associated with the use of
esfenvalerate and one incident associated with fenvalerate were found. 
Nine incidents were reported for aquatic animals and two are reported
for terrestrial animals and one for plants.  All incidents were reported
between 1991 and 1999.  Three of the incidents were associated with
registered uses of esfenvalerate, five were associated with uses where
it was undetermined if the use was a registered use, and four incidents
were associated with accidental misuse. The certainty that the incidents
were associated with esfenvalerate exposure was considered possible for
five incidents and probable for seven incidents.  All aquatic incidents
had pesticides other than esfenvalerate also associated with the
incident and therefore, it is not possible to conclude that
esfenvalerate alone caused fish kills.  However, a field study does
indicate that exposure to runoff from a field treated with fenvalerate
may result in a fish kill.  The incidents are summarized below and in  
REF _Ref236211282 \h  Table 4-3 .

Terrestrial Incident Involving Fenvalerate

Incident # B0000-502-83 - An incident with fenvalerate occurred in
Madison County, GA in 1998.  The report states that over the course of
the summer, a resident found birds dead on his property.  One of the
birds was submitted for examination and it was determined that
fenvalerate was present in the crop contents at 164 ppm.  No
organophosphates or carbamates were detected.  The decision made by the
Department of Parasitology, University of Georgia, was that toxicosis
was suspected but the specific toxicant was not determined. 
Specifically, the report stated, "Synthetic pyrethroids, such as
fenvalerate, are relatively non-toxic to warm-blooded animals.  In large
amounts they can cause nervous system problems.  The levels of
fenvalerate in this bird were not high enough to diagnose toxicosis as
the cause of death.”

Aquatic Incidents Involving Esfenvalerate

Incident # I000109-009 - An aerial application of esfenvalerate and
azinphos-methyl (AZM) to sugarcane in Iberville County, LA in July 1999
was suspected to have resulted in an incident involving over 2300
freshwater fish (species of gar, buffalo, and drum).  It was assumed
that the application, in concert with heavy rainfall, led to runoff that
caused fish kills in three waterways associated with the Whitewater
Canal.  According to the investigative reports there was lack of
agreement between the investigating teams as to what caused the fish
kill, specifically whether it was attributable to low dissolved oxygen
levels or AZM.  Dissolved oxygen levels were measured and found to be
satisfactory.  Screening analysis detected AZM in "low but possibly
significant quantities."  A panel group that reviewed the incident felt
that a combination of the two was responsible for the observed
mortality, although AZM was determined to be the “probable” cause,
esfenvalerate was determined to be a “possible” cause.  

Incident # I000247-004 - A fish kill took place in Theriot Canal in
LaFourche County, LA some time before August 15, 1992, which involved an
unknown amount of bass, bream, gar, and catfish.  The incident was two
miles long.  The notification of the fish kill was made on August 15,
but by that time the fish were in a state of advanced decay and none
were taken for analysis.  Sugarcane fields are in the area and on 8/12
Asana (esfenvalerate) was sprayed on 147 acres.  On 8/13 and 8/15,
azinphos-methyl was sprayed on a total of 270 acres.  Azinphos-methyl
was suspected to be the more probable cause of the fish kill, with
esfenvalerate listed as possible.

Incident # I002166-001 - It was reported that a spill occurred between
April 28 and May 1, 1995 on a tree farm in Wautauga County, NC when an
insecticide-laden tank was being towed uphill.  The tank contained
esfenvalerate and lindane.  Subsequently several hundred small brook
trout were found dead in a nearby stream.  Soil residue analyses were
made between the spill site and the stream as well as near the edge of
the stream.  Tissue residue analyses were made on live and dead stream
fish in order to determine the contribution of each pesticide to the
event.  Various amounts of lindane were found in soil, water and fish
tissue, so this pesticide was assigned a causality certainty rating of
probable.  Esfenvalerate was found in soil, a trace in stream water and
was not found in fish tissue, so it was ruled as a possible cause.  

Incident # I003596-001 and I002200-001 - A fish kill involving
approximately 10,000 trout took place on August 8, 1994 in Aroostook
County, Maine at the Maine/New Brunswick border where high acreages of
potatoes are grown.  Two compounds used just prior to the incident on
the U.S. side were Manex (maneb) and Asana (esfenvalerate); on the
Canadian side chlorothalonil had been used 5 days prior to the incident,
after which occurred heavy rains.  Approximately 10,000 brook trout were
found dead in a nearby pond that was fed by a brook.  These fish had
recently been released from a hatchery.  Three samples of water were
taken from the brook and the pond; a soil sample was taken from the bank
of the brook. According to the report all of these samples were below
the detection limit for the pesticides.  Three fish tissue samples were
assayed for each of the pesticides, and because of other environmental
variables, there was insufficient data to implicate these pesticides as
sole causative agent in the fish kill.  The conclusion reached in the
report was that the cause of the fish kill was not determinable.  

Incident # I006173-001 - A citizen reported that on October 2, 1997
Asana XL (esfenvalerate) was applied at a rate of 0.02 lb a.i/acre,
along with Thiodan (endosulfan) at rate of 1 qt/acre, to treat cowpeas
for curculio.   In addition a 4-11-11 fertilizer had recently been
applied to the field at rate of 20 gal./acre.  Five days later, it
rained 3"-5" in a short amount of time causing runoff to the nearby
fishpond.  Fish died shortly after in the pond.  The number and species
of fish killed was not reported.  This incident occurred in Texas.

Incident # I003659-001 – An incident occurred in Accomack County, VA
on July 1, 1996 in which thousands of clams in a hatchery were killed
when exposed to esfenvalerate, azinphos-methyl, and endosulfan.  A
farmer that raised the clams used water from nearby Gargatha Creek,
which was contaminated with pesticides as the result of tomato fields
nearby.  It was reported that runoff from these fields contaminates
nearby streams and kills shellfish.  

Incident # I003781-002 - A private citizen from Ledbetter, KY, called
DuPont and reported a fish kill in her pond in June 1996.  A neighbor
had used Asana XL on his tomatoes, and a subsequent rainfall may have
washed the Asana into the pond, killing the fish.  

Incident # I007984-010 – In March 1995, a spray rig containing 400
gallons of Asana and lindane overturned on a large farm and the mixture
seeped into a boggy area and nearby stream resulting in the death of an
unknown number of brook trout.    The spill was contained and
remediation included removing the soil and placing it in a plastic lined
bed.  The contaminated water was irrigated onto a Fraser Fir field. 
Charcoal was placed at the point of runoff to bind up any future
chemical seepage.  This incident occurred in Ashe County, NC.

Incident #I002200-001 – In August 1994, Maneb, esfenvalerate, and
chlorothalonil were applied to pesticides near pond five days before and
the next day there was severe rain. Pesticides were not found in water
and soil samples.  An unspecified number of juvenile brook trout were
found dead in a nearby pond.  The incident occurred in Aroostook, ME.

Terrestrial Incidents Involving Esfenvalerate

Incident # I008168-001 - On May 25, 1998, a cornfield in Broadway,
Rockingham County, VA was sprayed with a mixture of Princep 4L
(simazine), Extrazine II 4L (atrazine and simazine), Asana XL
(esfenvalerate), and Gramoxone Extra (paraquat).  Two weeks later a
neighbor noticed five dead Canada geese (Branta canadensis) and notified
the Office of Pesticide Services, Division of Consumer Protection,
Department of Agriculture and Consumer Services of Virginia.  An
inspection was made on June 26 at which time soil and vegetation samples
were taken along the bank near the creek in which the geese were found. 
Substantial concentrations of simazine, atrazine, and cyanazine were
found in these samples even though they were taken a month after the
spraying.  No analyses were made for paraquat or esfenvalerate, although
the certainty with which the incident was cause by paraquat was
considered to be probable.  All other chemicals involved were considered
possible.  The applicator was fined $520 for spraying too close to the
creek that was affected.  

Incident # I000710-001 - On September 7, 1993, six goats and two ducks
were reported to have been exposed to esfenvalerate in an agricultural
area.  The effect noted was incapacitation, but not mortality.  This
incident occurred in Twin Falls County, ID.  Few details are provided,
and the certainty of causality by esfenvalerate was determined to be
possible. 

Incident # I009262-113 - As part of its August, 1999 report of pesticide
incidents, Scotts Co. included a complaint from Marion County, Ohio. 
The complainant sprayed an apple tree with Bug-B-Gon Multi-Insect Liquid
at the rate of four tablespoons per gallon and all of the leaves turned
brown.  The accepted rate of spraying for a garden is two
tablespoons/gallon and the product is not registered for fruit trees.

Other Incidents Reported 

In a field study conducted in 1985, two significant runoff events
occurred and were followed by fish kills.  In the first runoff event, F
heteroclitus, Mugil Cephalus, Panaeus sp., and P. puglio (189 dead
organisms/50 m of stream) were found dead and laboratory toxicity tests
indicated that toxicity was most likely due to the presence of
fenvalerate.  Other fish kills were reported to be associated with
fenvalerate; however, other pesticides were also measured in runoff for
the other fish kills (memo from James Clark to R. Wilbhour:  Field
validation report from south Carolina. 05/19/1989).

Table   STYLEREF 1 \s  4 -  SEQ Table \* ARABIC \s 1  3 .  Wildlife
Incidents from the EIIS Database Associated with Esfenvalerate

Incident Number

Ground/Air

Formulation	Taxa 

 Site	Magnitude	Year	State	Use	Legality of Use	Certainty Category	Other
Associated Chemicals

Incident Involving Aquatic Organisms 

I000109-009

Aerial Spray

EC	Gar, Buffalo, and Drum 

Stream/ River 	2300	07/

1991	ME	Sugarcane	Undetermined	Possible	Azinphos-methyl (probable)

I000247-004

Aerial Spray

NR	Bass, Bream, Gar, and Catfish

Stream/river	2-miles long	08/ 1992	LA	Sugarcane	Registered

Use	Probable	azinphos-methyl (probable)

I002200-001

Not Reported

EC	Brook Trout

Pond	10,000	08/ 1994	ME	Potatoes	Registered Use	Probable	Maneb and
chlorothalonil

I007984-010

Spill

EC	Brook Trout

Stream/river	Unknown	03/ 1995	NC	Farm

	Misuse (accidental)	Probable	Lindane

I002166-001

Spill

EC	Juvenile Trout

Stream/river	100s	05/ 1995	NC	Tree Farm	Misuse (accidental)	Possible
Lindane

I003781-002

Ground Spray

NR	Unknown Fish

Pond	100s	06/ 1996	KY	Tomato	Undetermined	Probable	None

I003659-001

Ground Spray

NR	Clam

Hatchery	1000s	07/ 1996	VA	Tomato	Undetermined	Probable	Endosulfan and
azinphos-methyl

I006173-001

NR

NR	Unknown Fish

Pond

	Unknown	10/ 1997	TX	Agricultural Area	Registered Use	Probable
Endosulfan and fertilizer

I003596-001

NR

NR	Trout

Nearby	1000s	08/ 1994	ME	NR	Undetermined	Possible	Manab and
chlorothalonil

Incident Involving Terrestrial Organisms

I000710-001

NR

NR	Goat 

Duck	6 

2	09/ 1993	ID	Agricultural Area	Undetermined	Possible	None

I008168-001

Ground Spray

Flowable	Canada Goose

Creek	5	06/ 1998	VA	Corn	Misuse (accidental)	Possible	Simazine,
atrazine,

Cyanazine, and paraquat (probable)

I009262-113

Ground Spray

Flowable

	Apple Tree	1	08/ 1999	OH	Apple Tree	Misuse (accidental)	Probable	None

Abbreviations: NR=Not reported; EC=emulsifiable concentration

Ecosystems Potentially at Risk

The ecosystems potentially at risk are often extensive in scope,
therefore, it may not be possible to identify specific ecosystems during
the development of a nation-wide ecological risk assessment.  However,
in general terms, terrestrial ecosystems potentially at risk could
include the treated field and immediately adjacent areas that may
receive drift or runoff.  Areas adjacent to the treated field could
include cultivated fields, fencerows and hedgerows, meadows, fallow
fields or grasslands, woodlands, riparian habitats, and other
uncultivated areas.  

Aquatic ecosystems potentially at risk include water bodies adjacent to,
or down stream from, the treated field and might include impounded
bodies such as ponds, lakes and reservoirs, or flowing waterways such as
streams or rivers. For uses in coastal areas, aquatic habitat also
includes marine ecosystems, including estuaries.  

Assessment Endpoints

Assessment endpoints are defined as “explicit expressions of the
actual environmental value that is to be protected, operationally
defined by an ecological entity and its attributes”  ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>1998</Year><RecNum>13</RecNum
><DisplayText>(USEPA,
1998)</DisplayText><record><rec-number>13</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">13</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">373</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Guidelines for Ecological Risk
Assessment</title><secondary-title>United States Environmental
Protection Agency (USEPA)</secondary-title><tertiary-title>Risk
Assessment Forum.  Office of Research and
Development</tertiary-title></titles><number>EPA/630/R-95/002F</number><
dates><year>1998</year><pub-dates><date>April,
1998</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://cfpub.epa.gov/ncea/cfm
/recordisplay.cfm?deid=12460</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 1998) .  For
example, fish are valued ecological entities; reproduction and age class
structure are some of their important attributes.  Together fish and
reproduction and age class structure are an assessment endpoint. 
Selection of the assessment endpoints is based on valued entities (e.g.,
fish, birds), the ecosystems potentially at risk (e.g., water bodies,
riparian vegetation, and upland habitats), the transport pathways of
esfenvalerate (e.g., runoff, spray drift, etc.), and the routes by which
ecological receptors (e.g., organisms) are exposed to esfenvalerate
(e.g., direct contact, etc.).

Assessment endpoints for esfenvalerate include direct toxic effects on
the survival, reproduction, and growth of terrestrial and aquatic
organisms, as well as indirect effects, such as reduction of the prey
base or modification of habitat.  Measures of ecological effect for
different taxa are used to evaluate risk.  The measures of ecological
effect are generally evaluated based on acute and chronic toxicity
information from registrant-submitted guideline tests that are performed
on a limited number of organisms.  Additional ecological effects data
from the open literature will also be considered.

Conceptual Model

For a pesticide to pose an ecological or human health risk, it must
reach the ecological or human receptors in biologically significant
concentrations.  An exposure pathway is the means by which a pesticide
moves in the environment from a source to a receptor (e.g., organism). 
For a pathway to be complete, it must have a source, a release
mechanism, an environmental transport medium, a point of exposure for
the receptors, and a feasible route of exposure.

The conceptual model for esfenvalerate provides a written description
and visual representation of the predicted relationships between
esfenvalerate, potential routes of exposure, and the predicted effects
for the assessment endpoint. A conceptual model consists of two major
components: risk hypothesis and a conceptual diagram   ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>1998</Year><RecNum>13</RecNum
><DisplayText>(USEPA,
1998)</DisplayText><record><rec-number>13</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">13</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">373</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Guidelines for Ecological Risk
Assessment</title><secondary-title>United States Environmental
Protection Agency (USEPA)</secondary-title><tertiary-title>Risk
Assessment Forum.  Office of Research and
Development</tertiary-title></titles><number>EPA/630/R-95/002F</number><
dates><year>1998</year><pub-dates><date>April,
1998</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://cfpub.epa.gov/ncea/cfm
/recordisplay.cfm?deid=12460</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 1998) .

Risk Hypothesis

A risk hypothesis describes the predicted relationship among the
stressor, exposure, and assessment endpoint response along with the
rationale for their selection.  For esfenvalerate, the following overall
ecological risk hypothesis is being employed for this ecological risk
assessment:

Based on the application methods, mode of action, fate and transport,
and the sensitivity of non-target aquatic and terrestrial species,
esfenvalerate and its isomers have the potential to reduce survival,
reproduction, and/or growth in non-target terrestrial and aquatic
organisms when used in accordance with the current label.  These
non-target organisms include federally listed threatened and endangered
species as well as non-listed species.  

The specific exposure routes quantitatively evaluated include, water
concentrations, sediment or pore water exposure, spray drift residues on
dietary items, and residues in dietary items from bioaccumulation.  The
following hypotheses reflect these exposure pathways.

Esfenvalerate concentrations in water have the potential to reduce
survival, reproduction, and/or growth of aquatic vertebrates,
invertebrates, and plants.

Esfenvalerate residues on plants and other dietary surfaces deposited
with spray drift have the potential to reduce survival, reproduction,
and/or growth of terrestrial organisms such as birds, mammals,
invertebrates, and plants.  

Esfenvalerate residues in sediment may cause toxicity to benthic
organisms.

Esfenvalerate residues in aquatic organisms eaten by terrestrial
organisms may result in reduced survival, growth, and reproduction of
terrestrial organisms.

Conceptual Diagram

The environmental fate properties of esfenvalerate indicate that runoff,
spray drift, volatilization and direct spray represent potential
transport mechanisms of esfenvalerate to aquatic and terrestrial
habitats where non-target organism may be exposed.  These transport
mechanisms are depicted in the conceptual models below (  REF
_Ref227662072 \h  Figure 6-1  and   REF _Ref233782133 \h  Figure 6-2 )
along with the receptors of concern and the potential attribute changes
in the receptors due to exposures to esfenvalerate.   

  

Figure   STYLEREF 1 \s  6 -  SEQ Figure \* ARABIC \s 1  1 .  Conceptual
Model Depicting Exposure Pathways and Potential Risks to Aquatic
Organisms from the Use of Esfenvalerate.  Dashed lines indicate routes
of exposure considered of lower or negligible importance for
esfenvalerate.

 

Figure   STYLEREF 1 \s  6 -  SEQ Figure \* ARABIC \s 1  2 .  Conceptual
Model Depicting Exposure Pathways and Potential Risks to Terrestrial
Organisms from the Use of Esfenvalerate.  Dashed lines indicate routes
of exposure considered of lower importance for esfenvalerate.

Analysis Plan

In order to address the risk hypothesis, the potential for adverse
effects on the environment is estimated.  The use, environmental fate,
and ecological effects of esfenvalerate are characterized and integrated
to assess the risks.  This is accomplished using a risk quotient (ratio
of exposure concentration to effects concentration) approach.  Although
risk is often defined as the likelihood and magnitude of adverse
ecological effects, the risk quotient-based approach does not provide a
quantitative estimate of likelihood and/or magnitude of an adverse
effect.  However, as outlined in the Overview Document   ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2004</Year><RecNum>16</RecNum
><DisplayText>(USEPA,
2004)</DisplayText><record><rec-number>16</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">16</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">376</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Overview of the Ecological Risk
Assessment Process in the Office of Pesticide
Programs</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>Environmental Fate and
Effects Division.  Office of Pesticide
Programs.</tertiary-title></titles><dates><year>2004</year><pub-dates><d
ate>January 23, 2004</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.epa.gov/espp/consu
ltation/ecorisk-overview.pdf</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 2004) , the
likelihood of effects to individual organisms from particular uses of
esfenvalerate is estimated using the probit dose-response slope and
either the level of concern (discussed below) or the actual calculated
risk quotient value.  

This analysis plan will be revisited and may be revised depending upon
the data available in the open literature and the information submitted
by the public in response to the opening of the Registration Review
docket.

Stressors of Concern

Esfenvalerate, the active ingredient, is the primary stressor of
concern.  As discussed above, esfenvalerate may racemize in water and
all isomers (SS, SR, RS, and RR) are also considered stressors of
concern   ADDIN EN.CITE <EndNote><Cite><Author>European
Commission</Author><Year>2005</Year><RecNum>28</RecNum><DisplayText>(Eur
opean Commission, 2005; MRID 40999303,
1988)</DisplayText><record><rec-number>28</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">28</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">387</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>European
Commission,</author></authors></contributors><titles><title>Review
Report for the Active Substance
Esfenvalerate</title><secondary-title>European Commission. 
Directorate-General Heath &amp; Consumer
Protection.</secondary-title></titles><dates><year>2005</year></dates><l
abel>Esfenvalerate</label><urls><related-urls><url>http://ec.europa.eu/f
ood/plant/protection/evaluation/existactive/list1-15_en.pdf</url></relat
ed-urls></urls><access-date>Jun 19,
2009</access-date></record></Cite><Cite><Author>40999303</Author><Year>1
988</Year><RecNum>122</RecNum><record><rec-number>122</rec-number><forei
gn-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">122</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
40999303,</author></authors><secondary-authors><author>Lee,
P.</author></secondary-authors></contributors><titles><title>Hydrolysis
of Chlorophenyl-carbon 14 DPX-GB800 in Buffer Solutions of 5, 7, and
9</title></titles><pages>19</pages><volume>19</volume><number>Proj. Id
AMR-1185-88</number><keywords><keyword>Esfenvalerate</keyword></keywords
><dates><year>1988</year></dates><pub-location>E.I. du Pont de Nemours
and Co.,
Inc</pub-location><label>MRID</label><urls></urls></record></Cite></EndN
ote> (European Commission, 2005; MRID 40999303, 1988) . In limited
instances (when esfenvalerate is exposed to sunlight before sorbing to
soil or sediment), the photolysis degradates
4-chloro-alpha-(1-methylethyl)-benzeneacetic acid (CPIA) and
decarboxy-fenvalerate (CAS Number 66753-10-4) may form.  As noted in
Section   REF _Ref236557316 \r \h  3.3.1 , these degradates are expected
to be lower in toxicity and occur in lower concentrations in the
environment and are thus not expected to contribute substantially to the
exposure.  The SS-isomer may sterioisomerize into the RS and SR-isomers
in water.  However, application rates are based on the SS-isomer and
half-lives used in the exposure estimates are based on breakdown of the
combined isomers. Thus, in the aquatic environment, the estimated
concentration of the SS- isomer represents the sum of all isomers
present or the maximum concentration of the SS-isomer.  As the SS-isomer
is the most toxic isomer for insects, birds, and mammals and only
limited toxicity data is available for other individual isomers, this
may be assumed to be the most protective assumption   ADDIN EN.CITE  
ADDIN EN.CITE.DATA   (Adelsbach and Tjeerdema, 2003; ATSDR, 1993;
Eisler, 1992) .  Therefore, the focus of the assessment is expected to
be the parent, esfenvalerate.  However, the Agency will review all
available degradate toxicity data to identify any additional stressors
of concern when the assessment is performed.

In its ecological risk assessments, the Agency does not routinely
include an evaluation of mixtures of active ingredients, either those
mixtures of multiple active ingredients in product formulations or those
in the applicator’s tank.  In the case of the product formulations of
active ingredients (that is, a registered product containing more than
one active ingredient), each active ingredient is subject to an
individual risk assessment for regulatory decision regarding the active
ingredient on a particular use site.  If effects data are available for
a formulated product containing more than one active ingredient, the
data may be used qualitatively or quantitatively in accordance with the
Agency’s Overview Document and the Services’ Evaluation Memorandum  
ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2004</Year><RecNum>16</RecNum
><DisplayText>(USEPA, 2004; Williams and Hogarth,
2004)</DisplayText><record><rec-number>16</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">16</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">376</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Overview of the Ecological Risk
Assessment Process in the Office of Pesticide
Programs</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>Environmental Fate and
Effects Division.  Office of Pesticide
Programs.</tertiary-title></titles><dates><year>2004</year><pub-dates><d
ate>January 23, 2004</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.epa.gov/espp/consu
ltation/ecorisk-overview.pdf</url></related-urls></urls><access-date>Jun
e 19,
2009</access-date></record></Cite><Cite><Author>Williams</Author><Year>2
004</Year><RecNum>21</RecNum><record><rec-number>21</rec-number><foreign
-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">21</key><key app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">381</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Williams,
Steve</author><author>Hogarth,
William</author></authors><tertiary-authors><author>Susan
Hazen</author></tertiary-authors></contributors><titles><title>Letter
providing an evaluation by the U.S. Fish and Wildlife Service and
National Marine Fisheries Service of an approach to assessing the
ecological risks of pesticide products</title></titles><edition>United
States Fish and Wildlife Service (USFWS) and National Marine Fisheries
Service (NMFS)</edition><dates><year>2004</year><pub-dates><date>January
26,
2004</date></pub-dates></dates><urls></urls></record></Cite></EndNote>
(USEPA, 2004; Williams and Hogarth, 2004) .     

Available toxicity data for environmental mixtures of esfenvalerate with
other pesticides will be presented as part of the ecological risk
assessment.  It is expected that the toxic effect of esfenvalerate, in
combination with other pesticides used in the environment, is likely to
be a function of many factors including but not necessarily limited to:
(1) the exposed species, (2) the co-contaminants in the mixture, (3) the
ratio of esfenvalerate and co-contaminant concentrations, (4)
differences in the pattern and duration of exposure among contaminants,
and (5) the differential effects of other physical/chemical
characteristics of the receiving waters (e.g. organic matter present in
sediment and suspended water).  Quantitatively predicting the combined
effects of all these variables on mixture toxicity to any given taxa
with confidence is beyond the capabilities of the available data and
methodologies.  However, a qualitative discussion of implications of the
available pesticide mixture effects data on the confidence of risk
assessment conclusions will be addressed as part of the uncertainty
analysis.

Piperonyl butoxide and MGK are commonly used in formulations with
pyrethroids, including esfenvalerate.  Piperonyl butoxide acts as a
potentiator in both mammals and insects   ADDIN EN.CITE
<EndNote><Cite><Author>Hodgson</Author><Year>2001</Year><RecNum>40</RecN
um><DisplayText>(Barile, 2004; Hodgson and Smart,
2001)</DisplayText><record><rec-number>40</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">40</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">399</key></foreign-keys><ref-type
name="Edited Book">28</ref-type><contributors><authors><author>Hodgson,
Ernest</author><author>Smart, Robert
C</author></authors></contributors><titles><title>Introduction to
Biochemcial
Toxicology</title></titles><edition>Third</edition><dates><year>2001</ye
ar></dates><pub-location>New
York</pub-location><publisher>Wiley-Interscience</publisher><urls></urls
></record></Cite><Cite><Author>Barile</Author><Year>2004</Year><RecNum>4
1</RecNum><record><rec-number>41</rec-number><foreign-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">41</key><key app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">400</key></foreign-keys><ref-type
name="Book">6</ref-type><contributors><authors><author>Barile, Frank
A</author></authors></contributors><titles><title>Clinical Toxicology: 
Principles and
Mechanisms</title></titles><dates><year>2004</year></dates><pub-location
>Boca Raton, FL</pub-location><publisher>CRC
Press</publisher><urls></urls></record></Cite></EndNote> (Barile, 2004;
Hodgson and Smart, 2001) .  Piperonyl butoxide has biphasic effects on
cytochrome P450 and is also a non-specific esterase inhibitor. 
Cytochrome P450 hemoproteins, the carbon monoxide-binding pigment of
microsomes, are involved in Phase I reactions that introduce a polar
functional group to chemicals which, in most cases, is followed by
conjugation during Phase II reactions and excretion. 
Methylenedioxyphenyl compounds such as piperonyl butoxide and safrole,
have a highly reactive carbene that reacts with the heme iron of
cytochrome P450 to form a P450 inhibitory complex that cannot react with
carbon monoxide or other substrate.  After approximately twelve hours,
induction of cytochrome P450 occurs   ADDIN EN.CITE
<EndNote><Cite><Author>Hodgson</Author><Year>2001</Year><RecNum>40</RecN
um><DisplayText>(Hodgson and Smart,
2001)</DisplayText><record><rec-number>40</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">40</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">399</key></foreign-keys><ref-type
name="Edited Book">28</ref-type><contributors><authors><author>Hodgson,
Ernest</author><author>Smart, Robert
C</author></authors></contributors><titles><title>Introduction to
Biochemcial
Toxicology</title></titles><edition>Third</edition><dates><year>2001</ye
ar></dates><pub-location>New
York</pub-location><publisher>Wiley-Interscience</publisher><urls></urls
></record></Cite></EndNote> (Hodgson and Smart, 2001) .  Exposure to
pyrethroids along with piperonyl butoxicide increases the toxicity of
the pyrethroids because the pyrethroid is not metabolized and excreted
as quickly.  MGK-264, another potentiator/synergist used with
pyrethroids, has similar biphasic effects (inhibition followed by
induction) on P450 isozymes as those observed for piperonyl butoxide;
however the results are less pronounced   ADDIN EN.CITE
<EndNote><Cite><Author>Hodgson</Author><Year>2001</Year><RecNum>40</RecN
um><DisplayText>(Hodgson and Smart,
2001)</DisplayText><record><rec-number>40</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">40</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">399</key></foreign-keys><ref-type
name="Edited Book">28</ref-type><contributors><authors><author>Hodgson,
Ernest</author><author>Smart, Robert
C</author></authors></contributors><titles><title>Introduction to
Biochemcial
Toxicology</title></titles><edition>Third</edition><dates><year>2001</ye
ar></dates><pub-location>New
York</pub-location><publisher>Wiley-Interscience</publisher><urls></urls
></record></Cite></EndNote> (Hodgson and Smart, 2001) .  

The Agency routinely assesses potential exposure to formulations by
examining acute exposure to spray drift.  Acute toxicity data on the
formulation is compared to potential exposure to spray drift. 
Esfenvalerate does have multiple active ingredients formulations that
include piperonyl butoxide, MGK, and other pesticides; however, the
formulations are used to treat ant mounds, as surface sprays around
homes, as crack and crevice treatments, and as wasp and hornet sprays ( 
REF _Ref231091652 \h  Appendix C ).  The spray drift associated with
these uses will be minimal and therefore, a quantitative assessment of
this potential aquatic exposure to formulations containing other
specified active ingredients is not necessary.  Toxicity data on
formulations for terrestrial organisms may be used to evaluate potential
exposure to terrestrial organisms.   

Measures of Exposure

In order to estimate risks of esfenvalerate exposures in aquatic and
terrestrial environments, all exposure modeling and resulting risk
conclusions will be made based on maximum application rates for
esfenvalerate.  Measures of exposure are based on aquatic and
terrestrial models that predict estimated environmental concentrations
of esfenvalerate using maximum labeled application rates and methods, as
well as any mitigation measures specifically indicated on the label
(e.g. spray drift buffers).  The models used to predict aquatic EECs are
the Pesticide Root Zone Model coupled with the Exposure Analysis Model
System (PRZM/EXAMS).  The model used to predict terrestrial EECs on food
items is Terrestrial Residue EXposure model (T-REX model).  The KOW
based Aquatic BioAccumulation Model (KABAM) is used to estimate
potential bioaccumulation of organic pesticides in freshwater aquatic
food webs and subsequent risks to mammals and birds via consumption of
contaminated prey.  The earthworm fugacity model will be used to
estimate exposure to organisms via consumption of contaminated
terrestrial prey.  TerrPlant is also available to estimate EECs relevant
to terrestrial and wetland plants; however, toxicity values are not
available for calculation of RQs, so a qualitative judgment will be made
unless more data become available.

Aquatic Organisms

PRZM (v3.12.2, May 2005) and EXAMS (v2.98.4.6, April 2005) are screening
simulation models coupled with the input shell pe5.pl (Aug 2007) to
generate daily exposures and 1-in-10 year EECs of esfenvalerate that may
occur in surface water bodies adjacent to application sites receiving
esfenvalerate through runoff and spray drift.  PRZM simulates pesticide
application, movement and transformation on an agricultural field and
the resultant pesticide loadings to a receiving water body via runoff,
erosion and spray drift.  EXAMS simulates the fate of the pesticide and
resulting concentrations in the water body.  The standard scenario used
for ecological pesticide assessments assumes application to a 10-hectare
agricultural field that drains into an adjacent 1-hectare water body,
2-meters deep (20,000 m3 volume) with no outlet.  PRZM/EXAMS is used to
estimate screening-level exposure of aquatic organisms to esfenvalerate.
 The measure of exposure for aquatic species is the 1-in-10 year return
peak or rolling mean concentration.  The 1-in-10 year peak is used for
estimating acute exposures of direct effects of aquatic organisms to
esfenvalerate, as well as indirect effects to endangered aquatic species
through effects to potential prey items, including algae, aquatic
invertebrates, fish and frogs. The 1-in-10-year 60-day mean is used for
assessing chronic exposure to fish and aquatic-phase amphibians; the
1-in-10-year 21-day mean is used for assessing chronic exposure for
aquatic invertebrates.

Given the aquatic toxicity of esfenvalerate and its likelihood of
occurring in sediment, the Agency will also consider the potential
exposures resulting from benthic/sediment concentrations (EECs).  Pore
water concentrations are commonly used to predict toxicity of non-ionic
substances in sediments and characterize exposure to organisms that
spend time in or near sediments   ADDIN EN.CITE
<EndNote><Cite><Author>DiToro</Author><Year>1991</Year><RecNum>35</RecNu
m><DisplayText>(DiToro<style face="italic"> et al.</style>, 1991; USEPA,
2003)</DisplayText><record><rec-number>35</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">35</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">394</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>DiToro,
D.M.</author><author>Zarba, C.S.</author><author>Hansen,
D.J.</author><author>Berry, W.J.</author><author>Schwartz,
R.C.</author><author>Cowan, C.E.</author><author>Pavlou,
S.P.</author><author>Allen, H.E.</author><author>Thomas,
N.A.</author><author>Paquin,
R.R.</author></authors></contributors><titles><title>Technical basis for
establishing sediment quality criteria for nonionic organic chemicals
using equilibrium partitioning</title><secondary-title>Environmental
Toxicology and
Chemistry</secondary-title></titles><periodical><full-title>Environmenta
l Toxicology and
Chemistry</full-title></periodical><pages>1541-1586</pages><volume>10</v
olume><dates><year>1991</year></dates><urls></urls></record></Cite><Cite
><Author>USEPA</Author><Year>2003</Year><RecNum>36</RecNum><record><rec-
number>36</rec-number><foreign-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">36</key><key app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">395</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>USEPA,</author></a
uthors></contributors><titles><title>Technical basis for the derivation
of equilibrium partitioning sediment benchmarks (ESBs) for the
protection of benthic organisms: Nonionic organics
(draft)</title><tertiary-title>Office of Research and Development. 
United States Environmnetal Protection
Agency</tertiary-title></titles><number>EPA-600-R-02-014</number><dates>
<year>2003</year></dates><urls></urls></record></Cite></EndNote> (DiToro
et al., 1991; USEPA, 2003) .  PRZM/EXAMS also estimates 1-in-10-year
peak, 21-day mean, and 60-day mean EECs for pore water.  Total sediment
concentrations may also be used to predict exposure to organisms.  For
example, total sediment concentrations may be used to predict exposure
from ingested sediment.  

Terrestrial Organisms

Terrestrial wildlife may be exposed to esfenvalerate via consumption of
esfenvalerate on food sprayed directly with esfenvalerate or food items
exposed to esfenvalerate via spray drift.   

Residues on Terrestrial Invertebrates and Dietary Items of Terrestrial
Organisms

Exposure estimates for terrestrial animals assumed to be in the target
area or in an area exposed to spray drift are derived using the
(Terrestrial Residue EXposure model) T-REX model.    SEQ CHAPTER \h \r 1
This model incorporates the Kenaga nomograph, as modified by Fletcher et
al.   ADDIN EN.CITE
<EndNote><Cite><Author>Fletcher</Author><Year>1994</Year><RecNum>26</Rec
Num><DisplayText>(Fletcher<style face="italic"> et al.</style>,
1994)</DisplayText><record><rec-number>26</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">26</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">386</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Fletcher,
J.S.</author><author>Nellessen, J.E.</author><author>Pfleeger,
T.G.</author></authors></contributors><titles><title>Literature review
and evaluation of the EPA food-chain (Kenaga) nomogram, an instrument
for estimating pesticide residues on
plants</title><secondary-title>Environmental Toxicology and
Chemistry</secondary-title></titles><periodical><full-title>Environmenta
l Toxicology and
Chemistry</full-title></periodical><pages>1383-1391</pages><volume>13</v
olume><dates><year>1994</year></dates><urls></urls></record></Cite></End
Note> (Fletcher et al., 1994) , which is based on a large set of actual
field residue data. The upper limit values from the nomograph represent
the 95th percentile of residue values from actual field measurements  
ADDIN EN.CITE
<EndNote><Cite><Author>Hoerger</Author><Year>1972</Year><RecNum>24</RecN
um><DisplayText>(Hoerger and Kenaga,
1972)</DisplayText><record><rec-number>24</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">24</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">384</key></foreign-keys><ref-type name="Book
Section">5</ref-type><contributors><authors><author>Hoerger,
F.</author><author>Kenaga,
E.E.</author></authors><secondary-authors><author>Coulston,
F.</author><author>Korte,
F.</author></secondary-authors></contributors><titles><title>Pesticide
Residues on Plants: Correlation of Representative Data as a Basis for
Estimation of their Magnitude in the
Environment</title><secondary-title>Environmental Quality and Safety:
Chemistry, Toxicology, and
Technology</secondary-title></titles><dates><year>1972</year></dates><pu
b-location>Stuttgart, West Germany</pub-location><publisher>Georg Thieme
Publ</publisher><urls></urls></record></Cite></EndNote> (Hoerger and
Kenaga, 1972) .  The Fletcher et al.(1994) modifications to the Kenaga
nomograph are based on measured field residues from 249 published
research papers, including information on 118 species of plants, 121
pesticides, and 17 chemical classes   ADDIN EN.CITE
<EndNote><Cite><Author>Fletcher</Author><Year>1994</Year><RecNum>26</Rec
Num><DisplayText>(Fletcher<style face="italic"> et al.</style>,
1994)</DisplayText><record><rec-number>26</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">26</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">386</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Fletcher,
J.S.</author><author>Nellessen, J.E.</author><author>Pfleeger,
T.G.</author></authors></contributors><titles><title>Literature review
and evaluation of the EPA food-chain (Kenaga) nomogram, an instrument
for estimating pesticide residues on
plants</title><secondary-title>Environmental Toxicology and
Chemistry</secondary-title></titles><periodical><full-title>Environmenta
l Toxicology and
Chemistry</full-title></periodical><pages>1383-1391</pages><volume>13</v
olume><dates><year>1994</year></dates><urls></urls></record></Cite></End
Note> (Fletcher et al., 1994) .  For aerial applications of pellet or
granular formulations, an estimation of loadings of pesticide per unit
area is calculated using the T-REX model.  No drift is assumed for
ground applications of pellet and granular formulations.  For broadcast
spray applications, the T-REX model is also used to predict dietary
exposure of birds and mammals to esfenvalerate residues on foliar
surfaces and insects using the Kenaga nomogram as modified by Fletcher  
ADDIN EN.CITE
<EndNote><Cite><Author>Hoerger</Author><Year>1972</Year><RecNum>24</RecN
um><DisplayText>(Fletcher<style face="italic"> et al.</style>, 1994;
Hoerger and Kenaga,
1972)</DisplayText><record><rec-number>24</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">24</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">384</key></foreign-keys><ref-type name="Book
Section">5</ref-type><contributors><authors><author>Hoerger,
F.</author><author>Kenaga,
E.E.</author></authors><secondary-authors><author>Coulston,
F.</author><author>Korte,
F.</author></secondary-authors></contributors><titles><title>Pesticide
Residues on Plants: Correlation of Representative Data as a Basis for
Estimation of their Magnitude in the
Environment</title><secondary-title>Environmental Quality and Safety:
Chemistry, Toxicology, and
Technology</secondary-title></titles><dates><year>1972</year></dates><pu
b-location>Stuttgart, West Germany</pub-location><publisher>Georg Thieme
Publ</publisher><urls></urls></record></Cite><Cite><Author>Fletcher</Aut
hor><Year>1994</Year><RecNum>26</RecNum><record><rec-number>26</rec-numb
er><foreign-keys><key app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">26</key><key app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">386</key></foreign-keys><ref-type
name="Journal
Article">17</ref-type><contributors><authors><author>Fletcher,
J.S.</author><author>Nellessen, J.E.</author><author>Pfleeger,
T.G.</author></authors></contributors><titles><title>Literature review
and evaluation of the EPA food-chain (Kenaga) nomogram, an instrument
for estimating pesticide residues on
plants</title><secondary-title>Environmental Toxicology and
Chemistry</secondary-title></titles><periodical><full-title>Environmenta
l Toxicology and
Chemistry</full-title></periodical><pages>1383-1391</pages><volume>13</v
olume><dates><year>1994</year></dates><urls></urls></record></Cite></End
Note> (Fletcher et al., 1994; Hoerger and Kenaga, 1972) .  The residue
estimates on insects are also used to estimate terrestrial exposure to
insects.

For broadcast spray to soil or ant mounds the mass of the pesticide
applied per unit area of the treated zone will be calculated using
T-REX.  This basic approach is compared to single bird or mammal dose
levels and is based on an assumption of bioavailability of the pesticide
via one or more exposure routes (e.g. dietary, incidental soil
ingestion, dermal contact, drinking water, and inhalation).  No soil
incorporation will be assumed and so 100 percent of the applied
esfenvalerate will be assumed to be bioavailable.  This analysis will be
conducted for an area being treated and for an acre using an estimate of
the number of ant mounds per acre.

Exposure to Terrestrial Plants

Estimated Environmental Concentrations (EECs) for terrestrial plants
inhabiting dry and wetland areas are derived using TerrPlant.  This
model uses estimates of pesticides in runoff and in spray drift to
calculate EECs.  EECs are based upon solubility, application rate, and
minimum incorporation depth.

Injection to Ant Mounds 

A standard model to estimate exposure of birds and mammals to pesticides
injected into ant mounds is not currently available.  The Agency is
still developing an approach to assess potential exposure for this use. 
The approach is anticipated to involve estimating exposure based on the
ingestion of ants with residues of esfenvalerate.

Residues in Organisms (Bioaccumulation)

Because there is some evidence of the potential for bioaccumulation of
esfenvalerate in aquatic organisms, an additional exposure pathway that
will be considered in this assessment is the consumption of contaminated
fish or aquatic invertebrates that have bioaccumulated esfenvalerate
dissolved in water and their aquatic diet.  Multiple lines of evidence
will be used to evaluate bioaccumulation potential, including measured
bioconcentration factors (BCF), bioaccumulation factors (BAF) and a food
web bioaccumulation model (Kow-Based Aquatic Bioaccumulation Model or
KABAM).  The bioaccumulation assessment relies on predicted water and
sediment concentrations from PRZM/EXAMS to estimate concentrations of
esfenvalerate in aquatic organisms.  These estimated tissue
concentrations will be compared to toxicity values for various taxonomic
groups that may eat aquatic organisms in order to evaluate potential
risk.

The potential for exposure of listed species through consumption of
contaminated terrestrial prey will be evaluated by fugacity modeling for
the earthworm based on predicted concentrations of endosulfan in soil
and soil pore water using PRZM.

Measures of Effect

Ecological effects data are used as measures of direct and indirect
effects to biological receptors.  Data are obtained from
registrant-submitted studies or from literature studies identified by
ECOTOX.  The ECOTOX database   ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2009</Year><RecNum>19</RecNum
><DisplayText>(USEPA,
2009b)</DisplayText><record><rec-number>19</rec-number><foreign-keys><ke
y app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">19</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">379</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>ECOTOXicology
Database</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>National Health and
Environmental Effects Research Laboratory&apos;s Mid-Continent Ecology
Division).Office of Research and
Development.</tertiary-title></titles><dates><year>2009</year></dates><u
rls><related-urls><url>http://cfpub.epa.gov/ecotox/</url></related-urls>
</urls><access-date>June 19,
2009</access-date></record></Cite></EndNote> (USEPA, 2009b)  provides
more ecological effects data in an attempt to bridge existing data gaps.
 ECOTOX is a source for locating single chemical toxicity data and
potential chemical mixture toxicity data for aquatic life, terrestrial
plants, and wildlife.  ECOTOX was created and is maintained by the
USEPA, Office of Research and Development, and the National Health and
Environmental Effects Research Laboratory's Mid-Continent Ecology
Division.

Information on the potential effects of esfenvalerate on non-target
animals is also collected from the Ecological Incident Information
System (EIIS).  The EIIS is a database containing adverse effect
(typically mortality) reports on non-target organisms where such effects
have been associated with the use of pesticides.   

Where available, sublethal effects observed in both registrant-submitted
and open literature studies will be evaluated qualitatively.  Such
effects may include behavioral changes (e.g., lethargy and changes in
coloration).  Quantitative assessments of risks are limited to those
endpoints that can be directly linked to the Agency’s assessment
endpoints of impaired survival, growth, and reproduction.

The acute measures of effect used for animals in this assessment are the
LD50, LC50 and EC50.  LD stands for "Lethal Dose", and LD50 is the
amount of a material, given all at once, that is estimated to cause the
death of 50% of the test organisms.  LC stands for “Lethal
Concentration” and LC50 is the concentration of a chemical that is
estimated to kill 50% of the test organisms.  EC stands for “Effective
Concentration” and the EC50 is the concentration of a chemical that is
estimated to produce a specific effect in 50% of the test organisms. 
Endpoints for chronic measures of exposure for listed and non-listed
animals are the NOAEL/NOAEC and NOEC.  NOAEL stands for “No
Observed-Adverse-Effect-Level” and refers to the highest tested dose
of a substance that has been reported to have no harmful (adverse)
effects on test organisms.  The NOAEC (i.e.,
“No-Observed-Adverse-Effect-Concentration”) is the highest test
concentration at which none of the observed effects were statistically
different from the control.  The NOEC is the
No-Observed-Effects-Concentration.  For non-listed plants, only acute
exposures are assessed (i.e., EC25 for terrestrial plants and EC50 for
aquatic plants); for listed plants either the NOAEC or EC05 is used.   

In the absence of taxon-specific data,   SEQ CHAPTER \h \r 1 the
assessment of risk for direct effects to non-target organisms makes the
assumption that toxicity of esfenvalerate to birds is similar to
terrestrial-phase amphibians and reptiles.  The same assumption is made
for fish and aquatic-phase amphibians.  In the absence of data for
either acute or chronic effects, the conservative assumption will be to
presume that esfenvalerate is toxic. 

 Integration of Exposure and Effects

Risk characterization is the integration of exposure and ecological
effects characterization to determine the potential ecological risk from
the use of esfenvalerate as an insecticide and the likelihood of direct
and indirect effects to non-target organisms in aquatic and terrestrial
habitats.  The exposure and toxicity effects data are integrated in
order to evaluate the risks of adverse ecological effects on non-target
species.  For the assessment of esfenvalerate risks, the risk quotient
(RQ) method is used to compare exposure and measured toxicity values. 
EECs are divided by acute and chronic toxicity values.  The resulting
RQs are then compared to the Agency’s Levels of Concern (LOCs)   ADDIN
EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2004</Year><RecNum>16</RecNum
><DisplayText>(USEPA,
2004)</DisplayText><record><rec-number>16</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">16</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">376</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Overview of the Ecological Risk
Assessment Process in the Office of Pesticide
Programs</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>Environmental Fate and
Effects Division.  Office of Pesticide
Programs.</tertiary-title></titles><dates><year>2004</year><pub-dates><d
ate>January 23, 2004</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.epa.gov/espp/consu
ltation/ecorisk-overview.pdf</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 2004) . 
These criteria are used to indicate when fluridone’s uses, as directed
on the label, have the potential to cause adverse direct or indirect
effects to non-target organisms.  In addition, incident data from the
EIIS will be considered as part of the risk characterization.     

Deterministic and Probabilistic Assessment Methods

The quantitative assessment of risk will primarily depend on the
deterministic point-estimate based approach described in the risk
assessment.  An effort will be made to further qualitatively describe
risk using probabilistic tools that the Agency has developed.  These
tools have been reviewed by FIFRA Scientific Advisory Panels ( 
HYPERLINK "http://www.epa.gov/scipoly/sap/index.htm" 
http://www.epa.gov/scipoly/sap/index.htm ) and have been deemed as
appropriate means of refining assessments where deterministic approaches
have identified risks.

Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered
Species Act (ESA), the Agency will evaluate risks to Federally-listed
threatened and/or endangered (listed) species from registered uses of
Esfenvalerate.  This assessment will be conducted in accordance with the
Overview Document   ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2004</Year><RecNum>16</RecNum
><DisplayText>(USEPA,
2004)</DisplayText><record><rec-number>16</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">16</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">376</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Overview of the Ecological Risk
Assessment Process in the Office of Pesticide
Programs</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>Environmental Fate and
Effects Division.  Office of Pesticide
Programs.</tertiary-title></titles><dates><year>2004</year><pub-dates><d
ate>January 23, 2004</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.epa.gov/espp/consu
ltation/ecorisk-overview.pdf</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 2004) ,
provisions of the ESA, and the Services’ Endangered Species
Consultation Handbook   ADDIN EN.CITE
<EndNote><Cite><Author>USFWS/NMFS</Author><Year>1998</Year><RecNum>20</R
ecNum><DisplayText>(USFWS/NMFS,
1998)</DisplayText><record><rec-number>20</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">20</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">380</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USFWS/NMFS</a
uthor></authors></contributors><titles><title>Endangered Species
Consultation Handbook: Procedures for Conducting Consultation and
Conference Activities Under Section 7 of the Endangered Species Act. 
Final Draft</title><secondary-title>United States Fish and Wildlife
Service (USFWS) and National Marine Fisheries Service
(NMFS)</secondary-title></titles><dates><year>1998</year><pub-dates><dat
e>March 1998</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.fws.gov/endangered
/consultations/s7hndbk/s7hndbk.htm</url></related-urls></urls><access-da
te>June 19, 2009</access-date></record></Cite></EndNote> (USFWS/NMFS,
1998) .

The assessment of effects associated with the registration of
esfenvalerate is based on an action area.  The action area is considered
to be the area directly or indirectly affected by the federal action, as
indicated by the exceedance of Agency Levels of Concern (LOCs) used to
evaluate direct or indirect effects.  The Agency’s approach to
defining the action area under the provisions of the Overview Document  
ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2004</Year><RecNum>16</RecNum
><DisplayText>(USEPA,
2004)</DisplayText><record><rec-number>16</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">16</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">376</key></foreign-keys><ref-type
name="Generic">13</ref-type><contributors><authors><author>USEPA</author
></authors></contributors><titles><title>Overview of the Ecological Risk
Assessment Process in the Office of Pesticide
Programs</title><secondary-title>United States Environmental Protection
Agency (USEPA)</secondary-title><tertiary-title>Environmental Fate and
Effects Division.  Office of Pesticide
Programs.</tertiary-title></titles><dates><year>2004</year><pub-dates><d
ate>January 23, 2004</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing
Office</publisher><urls><related-urls><url>http://www.epa.gov/espp/consu
ltation/ecorisk-overview.pdf</url></related-urls></urls><access-date>Jun
e 19, 2009</access-date></record></Cite></EndNote> (USEPA, 2004) 
considers the results of the risk assessment process to establish
boundaries for that action area with the understanding that exposures
below the Agency’s defined LOCs constitute a no-effect threshold.  For
sublethal effects, an LOC has not been established and the action area
is defined based on potential exposure and the toxicity value where the
sublethal effect was observed.   For the purposes of this assessment,
attention will be focused on the footprint of the action (i.e., the area
where esfenvalerate application occurs), plus all areas where offsite
transport (i.e., spray drift, runoff, etc.) may result in potential
exposure that exceeds the Agency’s LOCs.  Specific measures of
ecological effect that define the action area for listed species include
any direct and indirect effects and/or potential modification of its
critical habitat, including reduction in survival, growth, and
reproduction as well as the full suite of sublethal effects available in
the effects literature.  Therefore, the action area extends to a point
where environmental exposures are below any measured lethal or sublethal
effect threshold for any biological entity at the whole organism, organ,
tissue, and cellular level of organization.  In situations where it is
not possible to determine the threshold for an observed effect, the
action area is not spatially limited and is assumed to be the entire
United States.

Drinking Water Assessment

A drinking water assessment will be conducted to support future human
health risk assessments of esfenvalerate. The drinking water assessment
will incorporate model estimates of esfenvalerate in surface water
sources of drinking water.  Concentrations of esfenvalerate in surface
waters will be estimated using PRZM/EXAMS (see description above).
Because esfenvalerate is not expected to leach through the soil to reach
ground water sources of drinking water because of it’s high sorption
potential and because the Koc values for esfenvalerate are outside of
the range used to develop SCI-GROW, OPP will not include ground water in
its drinking water assessment for esfenvalerate.  The drinking water
assessment will also include available water monitoring data, with
consideration of changes in use patterns since mitigations have been
imposed.  States are encouraged to submit monitoring data for review.

Although the high sorption potential of esfenvalerate for soil and
sediment suggests that chemical concentrations would likely be low in
water that has passed through a conventional
sedimentation-flocculation-disinfection treatment process, OPP is not
aware of any studies that substantiate the effect of conventional water
treatment processes on esfenvalerate.  The Agency will take into
consideration any information or data submitted on drinking water
treatment effects on esfenvalerate and use the information to the extent
that it is appropriate.  

Preliminary Identification of Data Gaps

Fate

Environmental fate data gaps exist for aerobic aquatic metabolism and
anaerobic aquatic metabolism, resulting in uncertainty in the assessment
of the stability of esfenvalerate in aquatic environments.  In the
absence of data, the Agency has used results of soil metabolism studies
to estimate aquatic metabolism rates for aquatic exposure modeling. The
aerobic aquatic metabolism half-life, reflective of the persistence of
esfenvalerate in the water column, was assumed to be twice that of the
aerobic soil metabolism half life.  The anaerobic aquatic metabolism
half-life, reflective of persistence in the sediment, was assumed to be
twice that of the anaerobic soil metabolism half-life.  

While only a single guideline study existed for both aerobic and
anaerobic soil metabolism, open literature (Laskowski, 2002; Kelley,
2007) provided a range of half-lives for these routes of degradation.

Only a single terrestrial field dissipation study, from 1990-1992, is
available to assess the dissipation of esfenvalerate under field
conditions. This limits the degree to which the Agency is able to
characterize the combined interaction of multiple routes of dissipation
in the field.

Limited information is available on the fate and transport of the four
stereoisomers for esfenvalerate. In the absence of such information, the
Agency assumed that all four isomers would behave similarly in the
environment. All degradation half-lives were based on the breakdown of
the molecule rather than any isomerization that might occur in the
environment. 

  REF _Ref231122691 \h  \* MERGEFORMAT  Table 7-1  summarizes the
submitted environmental fate studies.

Table   STYLEREF 1 \s  7 -  SEQ Table \* ARABIC \s 1  1 .  Summary of
Environmental Fate Studies

Guideline	Description	MRID	Classification	Data Gap?

835.2120	Hydrolysis	40999303	Acceptable	No

835.2240	Photodegradation in water	40443801	Acceptable	No

	Photodegradation on soil	41728501	Acceptable	No

835.4100	Aerobic soil metabolism	00146578	Acceptable	No

835.4200	Anaerobic soil metabolism	42396801	Acceptable	No

835.4300	Aerobic Aquatic Metabolism	Not available	NA	Yes

835.4400	Anaerobic Aquatic Metabolism	Not available	NA	Yes

835.1230

835.1240	 Leaching and adsorption/

desorption	45555102	Acceptable	No

164-1	Terrestrial Field Dissipation	41728502	Acceptable	No

835.6200	Aquatic (Sediment) Field Dissipation 	Not available	NA	No

165-4	Bioaccumulation in Fish	42922401 

42170501	Acceptable	No

	Environmental chemistry methods - water	41946401	Acceptable	No

850.7100	Environmental chemistry methods – sediment	47053001

47053002	Not yet reviewed

	

The BEAD Environmental Chemistry Laboratory reviewed an environmental
chemistry method for analyzing esfenvalerate in water in support of a
mesocosm study.  BEAD concluded that the method worked well with one
major modification   ADDIN EN.CITE
<EndNote><Cite><Author>Dupuy</Author><Year>1998</Year><RecNum>167</RecNu
m><DisplayText>(Dupuy,
1998)</DisplayText><record><rec-number>167</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">167</key></foreign-keys><re
f-type name="EPA Memo">2</ref-type><contributors><authors><author>Dupuy,
Aubry E.</author></authors><tertiary-authors><author>Leovey,
E.</author></tertiary-authors></contributors><titles><title>Asana Method
Evaluation Report No. ECM0007W1</title><tertiary-title>Environmental
Chemicstry Section.  Biological and Economic
Analysis</tertiary-title></titles><edition>United States Environmental
Protection
Agency</edition><keywords><keyword>Esfenvalerate</keyword></keywords><da
tes><year>1998</year><pub-dates><date>07/06/1998</date></pub-dates></dat
es><urls></urls></record></Cite></EndNote> (Dupuy, 1998) .  USGS dropped
esfenvalerate from its analytical schedules because of poor recoveries. 
OPP has received environmental chemistry methods for determining
residues of several synthetic pyrethroids, including esfenvalerate, in
sediment (guideline 850.7100). EFED has not yet reviewed this study. 

Effects

Although many submissions have been made to provide data on the effects
of esfenvalerate to aquatic and terrestrial organisms, several data gaps
still exist.    REF _Ref236236329 \h  

Table 7-2  and   REF _Ref236228531 \h  \* MERGEFORMAT  Table 7-3 
summarize the data submitted and data needed to assess the ecological
risk of the use of esfenvalerate as an insecticide.  All studies should
be conducted at high enough concentrations to predict toxicity at
predicted exposure levels.  Due to the variability in concentrations
observed in the available aquatic toxicity studies, concentrations
should be measured in all toxicity studies.  Additionally, flow through
studies are recommended.  All data should be submitted on the currently
registered SS-isomer.  Data gaps are listed below. 

Terrestrial Organisms

avian acute oral toxicity (Guideline 850.2100) study with a passerine
species and TGAI

avian reproduction studies (Guideline 850.2300) with an upland game bird
and waterfowl with TGAI

terrestrial plants seedling emergence and vegetative vigor studies
(Guideline 850.4100 and 850.4150) using the TEP

Aquatic Organisms

acute toxicity to freshwater fish (Guideline 850.1075) for one coldwater
and one warm water species using the TGAI

acute toxicity  to estuarine/marine fish (Guideline 850.1075) using the
TGAI and TEP for one species

acute toxicity to freshwater invertebrate (Guideline 850.1010) with a
TEP

acute toxicity to estuarine/marine invertebrate (Guideline 850.1025) for
the mollusk and another invertebrate species with TGAI and TEP

estuarine/marine invertebrate life cycle (850.1350) for one species

freshwater fish full lifecycle (Guideline 850.1500) for one species with
acute data

freshwater fish early life stage (Guideline  850.1400) for one species
with acute data, data from the fish full lifecycle may be used to
fulfill this guideline

estuarine/marine fish full life cycle (Guideline 850.1500) for one
species

estuarine/marine early life cycle (Guideline 850.1400) for one species,
data from the full lifecycle study may be used to fulfill this Guideline

whole sediment survival, growth, and reproduction tests with TGAI and
Chironomus tentans, Leptocheirus plumulosus, and Hyalella azteca

aquatic plant growth studies (Guideline 850.4400 and 850.5400) with TEP
or TGAI

Data gaps for the parent compound are discussed below and summarized in 
 REF _Ref236236329 \h  

Table 7-2  and   REF _Ref236228531 \h  \* MERGEFORMAT  Table 7-3 .   

Table   STYLEREF 1 \s  7 -  SEQ Table \* ARABIC \s 1  2 .  Available
Ecological Effects Data for Terrestrial Animals Exposed to Esfenvalerat
and Fenvalerate

Guideline

Description	Species	TGAI or TEP

SS or all isomers	MRID/

Classification	Data Gap?	Comments

850.2100

Avian oral toxicity1	Bobwhite Quail	TGAI

SS	41698401

Acceptable	Yes	Avian acute oral toxicity data are not available for
passerines, which are required under the new 40 CFR Part 158.  An acute
oral toxicity study using passerines must be submitted to fulfill this
data requirement.

	Bobwhite Quail	TGAI

All	41891909

Acceptable

850.2200

Avian dietary toxicity2

	Bobwhite Quail	TGAI

SS	41637803

Acceptable	No

Mallard Duck	TGAI

SS	41637802

Acceptable

	Mallard Duck	TGAI

All	41891911

Acceptable

	Bobwhite Quail	TGAI

All	41891910

Acceptable

850.2300

Avian reproduction2	Bobwhite Quail	TGAI

All	00037111

Supplemental	Yes	Avian reproductive toxicity studies on the racemic
mixture indicate that cracking of eggs may occur.  Exposure in the field
may be higher than the highest doses tests.  The SS-isomer is often more
toxic than the racemic mixture.  Avian reproductive toxicity tests are
needed for the SS-isomer with test concentrations that are high enough
to assess the exposures estimated to occur with the uses of
esfenvalerate.  

	Bobwhite Quail	TGAI

All	963-85

Supplemental

	Mallard Duck	TGAI

All	00037112

Supplemental

	Mallard Duck	TGAI

All	121827

Supplemental

	Bobwhite Quail	TGAI

All	109831

Supplemental

850.3020

Honeybee acute contact toxicity3	Honeybee	TGAI

SS	41698402

Acceptable	No

Honeybee	TGAI

All	111934

Not classified

	Honeybee	TGAI

All	246165/86066

Acceptable

	Honeybee	TEP

All	246165/86066

Acceptable

Field Study	Honeybee	TEP

All	86064

Acceptable	No

Honeybee	TEP

All	89065

Acceptable

1-  Data are required on one passerine species and either one waterfowl
species or one upland game bird species

2-  Data are required on waterfowl and upland game bird species.

3-  Data using the TGAI are required to support all outdoor end-use
product uses

Table   STYLEREF 1 \s  7 -  SEQ Table \* ARABIC \s 1  3 .  Available
Ecological Effects Data for Aquatic Animals Exposed to Esfenvalerate or
Fenvalerate 

Guideline Number

Description	Species	TGAI/ TEP	MRID/ Accession	Classification	Data Gap?
Comments

850.1075

Freshwater fish – 

Acute toxicity

Data needed for 1 coldwater species and 1 warm water species.  Data
needed for TEP if applied directly to water,  maximum EEC≥0.5 LC50, or
end product enhances toxicity

	Rainbow Trout	TEP

SS	43358311	Acceptable	Yes	Data are needed for 1 coldwater and 1
warmwater species using the TGAI.  The test should be completed on a
species that also has TEP data.

	Bluegill Sunfish	TEP

SS	43358312	Acceptable

	Bluegill Sunfish	TEP

NR	85723	Acceptable

	Channel Catfish	TEP

All	121829	Acceptable

	Bluegill Sunfish	TEP

All	41215202	Supplemental-quantitative for spray drift only

	Fathead Minnow	TGAI

All	41215201	Supplemental-qualitative

	Fathead Minnow	TGAI

All	41233002	Supplemental-qualitative

	Rainbow Trout	TEP

All	41233002	Supplemental-qualitative

	Rainbow Trout	TGAI

SS	41233001	Supplemental-qualitative

	Rainbow Trout	TGAI

All	121830	Supplemental-qualitative

	Rainbow Trout	TGAI

All	121833	Supplemental-qualitative

	Bluegill

Sunfish	TGAI

All	121830	Supplemental-qualitative

	Bluegill Sunfish	TGAI

All	121828	Supplemental-qualitative

	Channel Catfish	TGAI

All	71642	Supplemental-qualitative

	Rainbow Trout	TGAI

All	41891913

	Unacceptable

	Bluegill Sunfish	TGAI

All	41891912	Unacceptable

850.1075

Estuarine/Marine fish – 

Acute toxicity

Data needed for 1 species.  Data needed for TEP if applied directly to
water, maximum EEC≥0.5 LC50, or end product enhances toxicity.
Atlantic Silverside	TGAI

All	40228401	Supplemental-qualitative	Yes	Data are needed for one
species using the SS-isomer and the TGAI and for the TEP because the
maximum EEC is expected to be ≥ the 0.5 × LC50 based on the
freshwater acute toxicity data.

	Sheepshead Minnow	TGAI

All	40228401	Supplemental-qualitative

	California Grunion	TGAI

All	40228401	Supplemental-qualitative

850.1010

Freshwater invertebrates –

Acute toxicity

Data needed for one species.  Data needed for TEP if applied directly to
water, maximum EEC≥0.5 LC50, or end product enhances toxicity.

	Water flea	TGAI

All	41891914	Acceptable	Yes	Data are needed for one species using the
SS-isomer and a representative TEP because the maximum EEC (3.9 µg/L is
expected to be ≥ the 0.5 × LC50 (0.049 µg/L)   ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) 

	Water Flea	TGAI

82.8: 15.8 SS:All	42492602	Acceptable

	Water Flea	TGAI

SS	40444002	Supplemental-qualitative

	Water Flea	TEP

8.4:1.3 SS:All	42492601	Supplemental-qualitative

	Water Flea	TGAI

All	121830	Supplemental-qualitative

	Midge	TGAI

All	121830	Supplemental-qualitative

	Water Flea	TEP

SS	41798301	Supplemental-qualitative

	Water Flea	TEP

SS	43758313	Unacceptable

850.1025 oyster, 850.1035 mysid, 850.1045 Penaeid, 850.1055 bivalve

Estuarine/Marine invertebrates –

Acute toxicity1	Mysid Shrimp	TGAI	144839	Not Reviewed	Yes	Data are
needed for the mollusk and invertebrate for the TGAI and TEP because the
data available cannot be used quantitatively.

	Pink Shrimp	TGAI

All	40228401	Supplemental-qualitative

850.1300

Freshwater  invertebrate –

 life cycle

 Data required for 1 species.	Water Flea	TGAI

SS	40444001	Acceptable	No

Water Flea	TGAI

All	109887	Unacceptable

850.1350

E/M invertebrate – Life Cycle2	No data submitted	Yes	Data are needed
because the acute LC50 is less than  1 mg/L.

850.1400

Freshwater fish – 

early life stage test3

	Fathead Minnow	TGAI

All	97000	Unacceptable	Yes	Data are needed because chronic exposure may
occur; however, these data may be available from the fish full life
cycle study.

850.1400

E/M – 

early life stage test4

Yes	Data are needed because chronic exposure to E/M species may occur
and the acute LC50 < 1 mg/L; however, these data may be available from
the fish full life cycle study.

850.1500

Freshwater Fish – 

life cycle test5

	No data submitted	Yes	A study is needed for a fish with acute data
because reproductive effects were observed in the water flea   ADDIN
EN.CITE <EndNote><Cite><Author>MRID
40444001</Author><Year>1987</Year><RecNum>124</RecNum><DisplayText>(MRID
40444001,
1987)</DisplayText><record><rec-number>124</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">124</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
40444001,</author></authors><secondary-authors><author>Hutton,
D.</author></secondary-authors></contributors><titles><title>Chronic
Toxicity of Technical Asana Insecticide to Daphnia
magna:</title></titles><volume>21</volume><number>Haskell Laboratory
Report No.
589-87</number><keywords><keyword>Esfenvalerate</keyword></keywords><dat
es><year>1987</year></dates><pub-location>Unpublished study prepared by
E. I. du Pont de Nemours and Co.,
Inc</pub-location><label>MRID</label><urls></urls></record></Cite></EndN
ote> (MRID 40444001, 1987) .

850.1500

E/M Fish – 

 and the maximum 60 (0.65 µg/L) day EEC ≥ 0.1 × LC50 (0.31 µg/L)  
ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) .

0850.1735

Whole sediment acute freshwater invertebrate7	Midge	TGAI

SS	46591505	Preliminary Supplemental-qualitative	No	An aerobic aquatic
degradation half-life is not available; however the aerobic soil
metabolism half-life is > 10 days   ADDIN EN.CITE
<EndNote><Cite><Author>MRID
146578</Author><Year>1992</Year><RecNum>125</RecNum><DisplayText>(MRID
146578,
1992)</DisplayText><record><rec-number>125</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">125</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
146578,</author></authors><secondary-authors><author>Lee,
P.W.</author><author>Sterns, S.M.</author><author>Powell,
W.R.</author></secondary-authors></contributors><titles><title>Comparati
ve aerobic soil metabolism of SD 43775 (racemic) and SD 47443
(A-alpha)</title><secondary-title>Shell Development Company, Modesto,
CA</secondary-title></titles><number>MO-RIR-22-011-85.  Accession Number
258842</number><keywords><keyword>Esfenvalerate,
chlorpyrifos</keyword></keywords><dates><year>1992</year></dates><label>
MRID, Fate</label><urls></urls></record></Cite></EndNote> (MRID 146578,
1992) .  No data are needed.

850.1740

≥ 1000 L/kg   ADDIN EN.CITE
<EndNote><Cite><Author>45555102</Author><Year>2001</Year><RecNum>126</Re
cNum><DisplayText>(MRID 45555102,
2001)</DisplayText><record><rec-number>126</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">126</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
45555102, ,</author></authors><secondary-authors><author>Ohm,
M.</author></secondary-authors></contributors><titles><title>Adsorption/
Desorption of (Carbon 14)-esfenvalerate at a single concentration in six
soils</title></titles><number>Lab Project Number
DUPONT-3438</number><keywords><keyword>Esfenvalerate</keyword></keywords
><dates><year>2001</year></dates><pub-location>E.I. du Pont de Nemours
and Company</pub-location><label>MRID,
Fate</label><urls></urls></record></Cite></EndNote> (MRID 45555102,
2001) .  Currently EFED recommends survival, growth, and reproduction
testing on the Chironomus tentans, Leptocheirus plumulosus, and Hyalella
azteca   ADDIN EN.CITE   ADDIN EN.CITE.DATA   (USEPA, 2000, 2001) .

Abbreviations:  E/M = estuarine/marine; TEP=typical end use product;
TGAI=technical grade active ingredient; 

Data required for one mollusk and invertebrate.  Data needed for TEP if
applied directly to water, maximum EEC≥0.5 LC50, or end product
enhances toxicity.

Data are required for one species when the chemical is applied directly
to the E/M environment, acute LC50 < 1 mg/L, or the EEC is ≥0.01 of
acute LC50.

Data on one species are needed on a species with acute data.

Data are required for one species when the chemical is applied directly
to the E/M environment, acute LC50 < 1 mg/L, or the EEC is ≥0.01 of
acute LC50.

Data are required for one species when applied directly to water or if
EEC is ≥0.1 of NOEL in fish early life stage, or if studies suggest
reproduction physiology may be affected.

Data are required for one species when applied directly to water or if
EEC is ≥0.1 of NOEL in fish early life stage or if studies suggest
reproduction physiology may be affected.

Data are required when half-life of pesticide in sediment ≤ 10 days
and 1) the Kd is ≥50 L/kg, 2) the KOC ≥1000 L/kg, or the KOW
≥1000.

Data are required for one species for uses with direct application to
E/M water.  Data are required when half-life of pesticide in sediment
≤ 10 days and 1) the Kd is ≥50 L/kg, 2) the KOC ≥1000 L/kg, or the
KOW ≥1000 L/kg.

Data required if EEC> 0.1 of acute LC50 and the half-life > 10 days and
if any of the following exist:  the log KOW ≥3 or the KOC≥1000 L/kg.
 Data required for E/M when applied directly to E/M environment.

Avian Acute Oral Toxicity (Guideline 850.2100):  Passerine Species and
Upland Game Bird or Waterfowl Using the TGAI

Acceptable acute avian oral toxicity data were submitted for exposures
of bobwhite quail to esfenvalerate; however, data are not available for
passerines, which are required under the new 40 CFR Part 158 data
requirements for conventional pesticides (72 FR 60934; USEPA 2007b). 
The new Part 158 data requirements specify that acute avian oral
toxicity data be submitted for either a mallard duck or bobwhite quail
AND a passerine species.  EFED suggests that the Pesticide Re-Evaluation
Division (PRD) request submission of a passerine study protocol for
review by the Agency prior to initiation of this study.  If oral acute
toxicity data are not submitted for passerines, EFED will assume acute
risk for passerine species.  

Avian Reproduction Studies (Guideline 850.2300): Upland Game Bird and
Waterfowl Using the TGAI

No acceptable avian reproduction studies are available to evaluate the
reproductive and chronic toxicity of esfenvalerate to birds.  Birds may
be exposed to esfenvalerate on residues on food items.  If reproductive
toxicity data are not submitted for avian species, EFED will assume
chronic risk for avian species.

Terrestrial Plants (Guideline 850.4100 and 850.4150) using the TEP

Toxicity data for terrestrial plants are not available.  Based on the 40
CFR Part 158 data requirements, Tier I level non-target terrestrial
plant data are required for pesticides with a terrestrial, forestry, or
residential outdoor use patterns.  In addition, open literatures studies
have shown toxic effect to some plant species   ADDIN EN.CITE   ADDIN
EN.CITE.DATA   (Chauhan et al., 1999; El-Daly, 2006) .  Therefore, this
data gap must be filled and non-target terrestrial plant data are
required.  In the absence of Tier I data, EFED will use data available
from the open literature or will assume risk to terrestrial monocots and
dicots if no data are available.

	

The TEP tested should be a representative end-use product.  The proposed
rule establishing use of the TEP for vegetative vigor and seedling
emergence studies states, “The TEP that contains the highest
percentage of active ingredient, and/or is the most commonly used, would
be required.” (FR Vol. 70 No. 47; March 11, 2005; 12289).  

Aquatic Acute Toxicity Studies 

1) freshwater fish (Guideline 850.1075) for one coldwater and one
warmwater species using the TGAI, 

2) estuarine/marine fish (Guideline 850.1075) using the TGAI and TEP for
one species, 

3) freshwater invertebrate (Guideline 850.1010) using a TEP, and 

4) estuarine/marine invertebrate toxicity (Guideline 850.1025) for the
mollusk and another invertebrate species with TGAI and TEP

Quantitative acute toxicity to freshwater and estuarine/marine organisms
are not available for the TGAI or TEP as described above.  Based on the
40 CFR Part 158 data requirements, these data are required for all
esfenvalerate acute aquatic studies.  In addition, available qualitative
data and incident data indicate that direct effects are likely with use
of esfenvalerate as recommended on labels.  Therefore, these data gaps
must be filled.  In the absence of data, EFED will assume risk to both
freshwater and estuarine/marine fish and invertebrates.  Data on both
the TGAI and TEP should be available for the same species. 
Additionally, it is recommended that the study with the TEP be conducted
on the most sensitive species for a particular taxon.  The TEP used
should be an end-use product that is representative of products that may
result in spray drift to aquatic areas, e.g., one that is applied as a
liquid broadcast application.  This could be an emulsifiable
concentrate, flowable, or wettable powder.  Ideally, toxicity testing
representing each of these formulations would be available.  However, a
granular formulation should not be used.

Freshwater Fish Full Lifecycle (Guideline 850.1500) for One Species with
Acute Data

Estuarine/marine Fish Full Life Cycle (Guideline 850.1500) with TGAI and
Early Life Cycle (Guideline 850.1400)

40 CFR Part 158 requires an estuarine/marine fish full lifecycle study
for one species when the pesticide is applied directly to water or if
EEC is ≥0.1 of NOEL in fish early life stage or if studies suggest
reproduction physiology may be affected.  A study is needed for a fish
with acute data because reproductive effects were observed for the water
flea   ADDIN EN.CITE <EndNote><Cite><Author>MRID
40444001</Author><Year>1987</Year><RecNum>124</RecNum><DisplayText>(MRID
40444001,
1987)</DisplayText><record><rec-number>124</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">124</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
40444001,</author></authors><secondary-authors><author>Hutton,
D.</author></secondary-authors></contributors><titles><title>Chronic
Toxicity of Technical Asana Insecticide to Daphnia
magna:</title></titles><volume>21</volume><number>Haskell Laboratory
Report No.
589-87</number><keywords><keyword>Esfenvalerate</keyword></keywords><dat
es><year>1987</year></dates><pub-location>Unpublished study prepared by
E. I. du Pont de Nemours and Co.,
Inc</pub-location><label>MRID</label><urls></urls></record></Cite></EndN
ote> (MRID 40444001, 1987)  and the maximum 60 (0.65 µg/L) day EEC ≥
0.1 × LC50 (0.31 µg/L)   ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) . 
The early life stage test guideline may be fulfilled with data collected
in the measurement of the fish full life-cycle test.  Given that
fecundity endpoints are highly variable, the lab that conducts the test
should ensure that an appropriate number of replicates be used.  Usually
for nonparametric tests, a minimum of four replicates are required.

Whole Sediment Survival, Growth, and Reproduction Studies with
Chironomus tentans, Leptocheirus plumulosus, and Hyalella azteca   ADDIN
EN.CITE   ADDIN EN.CITE.DATA   (USEPA, 2000, 2001) 

An acute sediment toxicity test was requested for Chironomus tentans in
response to the 1999 SAP on pyrethroids   ADDIN EN.CITE
<EndNote><Cite><Author>Rexrode</Author><Year>2003</Year><RecNum>5</RecNu
m><DisplayText>(Rexrode and Melendez,
2003)</DisplayText><record><rec-number>5</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">5</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">365</key></foreign-keys><ref-type name="EPA
Memo">2</ref-type><contributors><authors><author>Rexrode,
Miachel</author><author>Melendez, Jose
Luis</author></authors><secondary-authors><author>United States
Environmental Protection
Agency</author></secondary-authors><tertiary-authors><author>Johnson,
M.</author><author>LaRocca,
G.</author></tertiary-authors></contributors><titles><title>EFED&apos;s
rationale for choosing Cypermethrin,, Esfenvalerate, Bifenthrin, and
Cyfluthrin for sediment testing as discussed with the Pyrethroid Working
Group (PWG)</title><tertiary-title>Environmental Fate and Effects
Division.  Office of Pesticide Programs.  United States Environmental
Protection
Agency</tertiary-title></titles><keywords><keyword>Pyrethroid,
esfenvalerate</keyword></keywords><dates><year>2003</year><pub-dates><da
te>December 23, 2003</date></pub-dates></dates><label>Ecological Risk
Assessment</label><urls></urls></record></Cite></EndNote> (Rexrode and
Melendez, 2003) .  The results would be used as representative for all
pyrethroids.  The submitted study (MRID 46591505, 2005) was conducted
using natural sediments and measured concentrations of esfenvalerate
were up to 160% of nominal.  The results of sediment testing were not
included in the study.  It is possible that the natural sediment was
contaminated with esfenvalerate and therefore, the control group was
also exposed to esfenvalerate.  This study has only undergone a
preliminary review; however, the results of the sediment testing should
be requested because they could reduce uncertainty in understanding the
results of the study.  Additionally, the dissolved oxygen concentrations
in two of the test concentrations were below 2 mg/L.  In 2007, 40 CFR
§158.630 was revised and an aquatic nontarget organism data requirement
for sediment testing of aquatic organisms was added.  The new data
requirements triggered for esfenvalerate include a chronic sediment
toxicity study for freshwater and marine organisms.  The current tests
needed include Whole Sediment Survival, Growth, and Reproduction Studies
with Chironomus tentans, Leptocheirus plumulosus, and Hyalella azteca  
ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>2000</Year><RecNum>245</RecNu
m><DisplayText>(USEPA,
2000)</DisplayText><record><rec-number>245</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">245</key></foreign-keys><re
f-type name="EPA
Document">51</ref-type><contributors><authors><author>USEPA,</author></a
uthors><secondary-authors><author>EPA
600/R-99/064</author></secondary-authors></contributors><titles><title>M
ethods for Measuring the Toxicity and Bioaccumulation of
Sediment-associated Contaminants with Freshwater Invertebrates.  Second
Edition.</title><secondary-title>March
2000</secondary-title><tertiary-title>Office of Research and
Development.  Office of Science and Technology.  Office of Water. United
States Environmental Protection
Agency</tertiary-title></titles><dates><year>2000</year></dates><urls><r
elated-urls><url>http://www.epa.gov/waterscience/cs/library/freshmanual.
pdf</url></related-urls></urls><access-date>October 29,
2009</access-date></record></Cite></EndNote> (USEPA, 2000) .  Test
protocols should be submitted before beginning the studies.  The acute
sediment toxicity study is not required because the half-life of
esfenvalerate is expected to be greater than 10 days based on soil
degradation data. Finally, a chronic estuarine/marine study was
previously requested on amphipods (Leptocheirus plumulosus).  A study
has been submitted (MRID 46620401) but not fully reviewed.  Reproduction
(#eggs/female, etc.) and behavior endpoints were not evaluated and are
needed to fulfill Leptocheirus plumulosus testing requirement. 
Therefore, a 28-day whole sediment toxicity test examining toxicity to
amphipods (Leptocheirus plumulosus) is still needed.

 ≥3 or the KOC≥1000 L/kg.  Data are needed for freshwater
invertebrates because:

the maximum 60-day (0.65 µg/L) day aquatic EEC ≥ 0.1 × 48-hr LC50
(0.049 µg/L) for the water flea   ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) ;

aerobic soil half-lives of esfenvalerate are greater than 10 days  
ADDIN EN.CITE <EndNote><Cite><Author>MRID
40999303</Author><Year>1988</Year><RecNum>122</RecNum><DisplayText>(MRID
40999303,
1988)</DisplayText><record><rec-number>122</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">122</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
40999303,</author></authors><secondary-authors><author>Lee,
P.</author></secondary-authors></contributors><titles><title>Hydrolysis
of Chlorophenyl-carbon 14 DPX-GB800 in Buffer Solutions of 5, 7, and
9</title></titles><pages>19</pages><volume>19</volume><number>Proj. Id
AMR-1185-88</number><keywords><keyword>Esfenvalerate</keyword></keywords
><dates><year>1988</year></dates><pub-location>E.I. du Pont de Nemours
and Co.,
Inc</pub-location><label>MRID</label><urls></urls></record></Cite></EndN
ote> (MRID 40999303, 1988) ;

 values are ≥ 1000 L/kg   ADDIN EN.CITE <EndNote><Cite><Author>MRID
45555102</Author><Year>2001</Year><RecNum>126</RecNum><DisplayText>(MRID
45555102,
2001)</DisplayText><record><rec-number>126</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">126</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
45555102, ,</author></authors><secondary-authors><author>Ohm,
M.</author></secondary-authors></contributors><titles><title>Adsorption/
Desorption of (Carbon 14)-esfenvalerate at a single concentration in six
soils</title></titles><number>Lab Project Number
DUPONT-3438</number><keywords><keyword>Esfenvalerate</keyword></keywords
><dates><year>2001</year></dates><pub-location>E.I. du Pont de Nemours
and Company</pub-location><label>MRID,
Fate</label><urls></urls></record></Cite></EndNote> (MRID 45555102,
2001) .  

In the absence of data, toxicity will be estimated using the lowest
chronic toxicity endpoint for freshwater invertebrates in freshwater and
the estimated pore water concentrations in sediment.

Aquatic Plant Studies (850.4400 and 850.5400) Using TEP or TGAI 

Toxicity data for vascular and non-vascular aquatic plants were not
submitted to the Agency.  Based on the 40 CFR Part 158 data
requirements, Tier I level non-target aquatic plant data are required
for all pesticides with outdoor uses that are not phytotoxicants.  In
the absence of Tier I data, EFED will assume risk to both vascular and
non-vascular aquatic plants.  If the TEP is used in testing, use an
end-use product that is representative of products that may result in
spray drift to aquatic areas, e.g., one that is applied as a liquid
broadcast application.  This could be an emulsifiable concentrate,
flowable, or wettable powder.  However, a granular formulation should
not be used.

Testing on Typical end-use products (TEP)

A Typical End-Use Product is defined in the Pesticide Assessment
Guidelines Subdivision J Hazard Evaluation:  Nontarget plants on Part
120-2(1) on Page 18 as “a pesticide product that is representative of
a major formulation category (e.g., emulsifiable concentrate, granular
product, wettable powder) and pesticide group (e.g., herbicide,
fungicide, insecticide etc.) and contains the active ingredient of the
applicant’s product.”   ADDIN EN.CITE
<EndNote><Cite><Author>Holst</Author><Year>1982</Year><RecNum>247</RecNu
m><DisplayText>(Holst and Ellwanger,
1982)</DisplayText><record><rec-number>247</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">247</key></foreign-keys><re
f-type name="EPA
Document">51</ref-type><contributors><authors><author>Holst, Robert
W.</author><author>Ellwanger, Thomas
C.</author></authors><secondary-authors><author>EPA-540/09-82-020</autho
r></secondary-authors></contributors><titles><title>Pesticide Assessment
Guidelines.  Subdivision J.  Hazard Evaluation:  Nontarget
Plants</title><secondary-title>October
1982</secondary-title><tertiary-title>Office of Pesticide Programs. 
Office of Pesticides and Toxic Substances.  United States Environmental
Protection
Agency</tertiary-title></titles><dates><year>1982</year></dates><pub-loc
ation>Washington,
D.C.</pub-location><urls></urls></record></Cite></EndNote> (Holst and
Ellwanger, 1982) 

Page 5 of the Pesticide Assessment Guidelines Subdivision J Hazard
Evaluation:  Nontarget plants provides additional information on what
TEP data should be tested for toxicity testing in the following excerpt.

	“The Agency seeks to avoid imposing a burden of duplicative testing
on applicants for registration.  Therefore, where 40 CFR Part 158
specifies that the test substance should be a representative end-use
product, testing may be performed using the formulation in question
(end-use product being registered) or similar, yet representative,
end-use product.  It is not necessary to repeat the test using other
similar products.”   ADDIN EN.CITE
<EndNote><Cite><Author>Holst</Author><Year>1982</Year><RecNum>247</RecNu
m><DisplayText>(Holst and Ellwanger,
1982)</DisplayText><record><rec-number>247</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">247</key></foreign-keys><re
f-type name="EPA
Document">51</ref-type><contributors><authors><author>Holst, Robert
W.</author><author>Ellwanger, Thomas
C.</author></authors><secondary-authors><author>EPA-540/09-82-020</autho
r></secondary-authors></contributors><titles><title>Pesticide Assessment
Guidelines.  Subdivision J.  Hazard Evaluation:  Nontarget
Plants</title><secondary-title>October
1982</secondary-title><tertiary-title>Office of Pesticide Programs. 
Office of Pesticides and Toxic Substances.  United States Environmental
Protection
Agency</tertiary-title></titles><dates><year>1982</year></dates><pub-loc
ation>Washington,
D.C.</pub-location><urls></urls></record></Cite></EndNote> (Holst and
Ellwanger, 1982) 

When TEP data are requested data should be submitted for the different
formulations, e.g., wettable powder, emulsifiable concentrate, granular,
along with a rationale as to why the TEP is representative of other
similar end-use products.

Other Information Needed for the Risk Assessment

Some residential uses also do not specify a maximum use rate per area. 
For example, a maximum single application rate is needed for home and
garden uses, ornamentals, and uses on elderberry and gooseberry.  A
maximum use rate per specified area is needed for all uses in order to
estimate exposure.  

Current labels do not have a maximum number of applications per year or
minimum application interval.  In order to estimate exposure, a maximum
number of applications per year or maximum number of seasons with a
maximum application rate per season and minimum application interval
will be assumed based on a conservative estimate.  Adding a maximum
number of applications and a minimum application interval to labels
would significantly reduce uncertainty in exposure estimates. 
Additionally, information on typical number of applications and
application intervals would be useful. 

References

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Prepared by Nelson Laboratories, Stockton, CA.  Submitted by E. I.
dupont de Nemours and Laboratories. 

MRID 42396801. V. Gassamidi & S. Bookhard. 1992. Anaerobic soil
metabolism of esfenvalerate:  Lab Project Number:  DUPONT-3438. 
Prepared by E.I. du Pont de Nemours and Company.  

MRID 45555102. M. Ohm. 2001. Adsorption/Desorption of (Carbon
14)-esfenvalerate at a single concentration in six soils. Lab Project
Number DUPONT-3438. Prepared by E.I. du Pont de Nemours and Company.  

MRID 46725304. A. Comb. 2002. Esfenvalerate (pure grade): 
Physico-chemical properties.  Project Number: VFX013/022699.  . 
Prepared by Huntingdon Life Sciences, Ltd.  Submitted by LG Chemical
Investment, Ltd. 

Nelson, H. 1990. EFGWB Review of Submission of Label and Tolerance
Petition for New Uses on Alfafa and Lettuce. June 28, 1990.
Environmental Fate and Effects Division, Office of Pesticide Programs,
United State Environmental Protection Agency. 

Rabert, W., Craven, H., & Maciorowski, A. F. 1995a. Ecological Effects
Branch Review of Esfenvalerate Use on Grain Sorghum. September 15, 1955.
Ecological Effects Branch.  Environmental Fate and Effects Division. 
Office of Pesticide Programs.  United States Environmental Protection
Agency. 

Rabert, W., Craven, H., & Maciorowski, A. F. 1995b. Ecological Effects
Branch Review of Esfenvalerate Use on Sugar Beets. November 8, 1995.
Ecological Effects Branch.  Environmental Fate and Effects Division. 
Office of Pesticide Programs.  United States Environmental Protection
Agency. 

Rabert, W., Craven, H., & Maciorowski, A. F. 1995c. Ecological Effects
Branch Review on the Section 3 Use of Esfenvalerate on Brussel Sprouts.
October 24, 1995. Ecological Effects Branch.  Environmental Fate and
Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection Agency. 

Rabert, W., Craven, H., & Maciorowski, A. F. 1995d. Ecological Effects
Branch Section 3 Review of Use of Esfenvalerate on Celery. October 20,
1995. Ecological Effects Branch.  Environmental Fate and Effects
Division.  Office of Pesticide Programs.  United States Environmental
Protection Agency. 

Rabert, W., Craven, H., & Maciorowski, A. F. 1995e. EEB Review of
Esfenvalerate Use on Head Lettuce. October 13, 1995. Ecological Effects
Branch.  Environmental Fate and Effects Division.  Office of Pesticide
Programs.  United States Environmental Protection Agency. 

Regelman, E. 1990a. EFGWB Review of Lable and Tolerance Petition
Amendment for 'Grass and Grass Hay'. April 6, 1990. Environmental Fate
and Effects Division.  Office of Pesticide Programs. United States
Environmental Protection Agency. 

Regelman, E. 1990b. Esfenvalerate label amendment and tolerance petition
amendment on the use of the active isomer instead of the racemic
mixture,  reduction of application rate, reduction of proposed tolerance
on celery and brussels sprouts. Memorandum From to G. LaRocca.  April
11, 1990. Environmental Fate and Ground Water Branch.  Environmental
Fate and Effects Division.  United States Environmental Protection
Agency.  

Rexrode, M. 1986. Substitution of SS isomer (ASANA) for the racemic
mixture (Pydrin). Memorandum From to G. LaRocca.  May 6, 1986.
Ecological Effect Branch.  Hazard Evaluation Division.  Office of
Pesticide Progams.  United States Environmental Protection Agency.  

Rexrode, M., & Melendez, J. L. 2003. EFED's rationale for choosing
Cypermethrin,, Esfenvalerate, Bifenthrin, and Cyfluthrin for sediment
testing as discussed with the Pyrethroid Working Group (PWG). Memorandum
From to M. Johnson & G. LaRocca.  December 23, 2003. Environmental Fate
and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection Agency.   

Rexrode, M., Rieder, D., & Maciorowski, A. F. 1993. Request by the
Washington Department of Agriculture for a Section 18 Emergency
Exemption for the Use of ASANA 1.9 EC or ASANA XL to Control Black Vine
Weevils on Cranberries. Memorandum From to Registration Division.  May
4, 1993. Ecological Effect Branch.  Environmental Fate and Effects
Division.  Office of Pesticide Programs.  United States Environmental
Protection Agency.  

Rexrode, M., Rieder, D., & Urban, D. 1992a. Proposed Section 18 (Texas)
registration for the use of esfenvalerate on leafy greens to control
cabbage looper. Memorandum From to R. Cool.  March 25, 1992. Ecological
Effects Branch.  Environmental Fate and Effects Division.  Office of
Pesticide Programs.  United States Environmental Protection Agency.  

Rexrode, M., Rieder, D., & Urban, D. 1992b. Review of Request for an
Experimental Use Permit in order to apply ASANA XL 0.66EC directly to
prairie wetlands in Minnesota. Memorandum From M. Rexrode, D. Rieder &
D. Urban to G. LaRocca.  March 25, 1992. Ecological Effects Branch. 
Environmental Fate and Effects Division. Office of Pesticide Programs. 
United States Environmental Protection Agency.  

Rexrode, M., Rieder, D., & Urban, D. 1992c. Review of Submission by the
Texas Department of Agriculture for an Emergency Exemption (Section 18)
for Use of Esfenvalerate (ASANA XL) on Leafy Greens for Control of
Cabbage Looper. Memorandum From to R. Cool.  March 19, 1992. Ecological
Effects Branch.  Environmental Fate and Effects Division.  Office of
Pesticide Programs.  United States Environmental Protection Agency.  

Rexrode, M., Rieder, D. D., & Akerman, J. 1991. Request for Patuxent
Wildlife Research Center, Laurel, MD (U.S. Fish and Wildlife Service)
for an Experimental Use Permit in order to apply ASANA XL directly to
prairie wetlands in Minnesota. Memorandum From to R. Division.  Jun 5,
1991. Environmental Fate and Effects Division.  Office of Pesticide
Programs.  United States Environmental Protection Agency.  

Rexrode, M., Stavola, A., & Akerman, J. 1990a. Proposed Section 3
registration for the use of esfenvalerate on rangeland and pasture.
Memorandum From to G. LaRocca.  June 5, 1990. Ecological Effects Branch.
 Environmental Fate and Effects Division. Office of Pesticide Programs. 
United States Environmental Protection Agency.  

Rexrode, M., Stavola, A., & Akerman, J. 1990b. Proposed Section 3
registration of esfenvalerate for use on sorghum. Memorandum From to G.
LaRocca.  June 5, 1990. Ecological Effects Branch.  Environmental Fate
and Effects Division.  United States Environmental Protection Agency.  

Rexrode, M., Stavola, A., & Akerman, J. 1990c. Proposed Section 3
registration of esfenvalerate on blueberries (and related bush berries),
caneberries, okra in Florida, ornamentals, and turnips. Memorandum From
to R. Division.  May 23, 1990. Ecological Effects Branch. Environmental
Fate and Effects Division. Office of Pesticide Programs.  United States
Environmental Protection Agency.  

Rexrode, M., Stavola, A., & Akerman, J. 1990d. Proposed Section 18
(Kansas) registration on the use of esfenvalerate to control western
pale cutworm and army cutworm in small grains. Memorandum From to R.
Division.  April 19, 1990. Ecological Effects Branch.  Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United State
Environmental Protection Agency.  

Rexrode, M., Stavola, A., & Akerman, J. 1990e. Proposed Section 18
(Minnesota) registration for the use of esfenvalerate to control
grasshopper species on small grains, conservation reserve, and wildlife
areas. Memorandum From to R. Division.  March 19, 1990. Ecological
Effects Branch.  Environmental Fate and Effects Division.  Office of
Pesticide Programs.  United States Environmental Protection Agency.  

Rexrode, M., Stavola, A., & Akerman, J. 1990f. Proposed Section 18
(North Dakota) registration on the use of esfenvalerate to control army
worms, western pale cutworms in winter wheat, and for grasshopper
control on small grains, in conservation reserve lands, and
non-cropland. Memorandum From to R. Division.  March 30, 1990.
Ecological Effects Branch.  Environmental Fate and Effects Division. 
United States Environmental Protection Agency.  

Rexrode, M., Stavola, A., & Akerman, J. 1990g. Proposed Section 18
(Washington) registration of esfenvalerate for use on cranberries to
control black vine weevils. Memorandum From to R. Division.  April 27,
1990. Ecological Effects Branch.  Environmental Fate and Effects
Division.  Office of Pesticide Programs.  United States Environmental
Protection Agency.  

Rexrode, M., Stavola, A., & Akerman, J. 1990h. Section 18 (Oklahoma)
registration on the use of esfenvalerate to control pale western cutworm
on winter wheat. Memorandum From to Registration Division.  March 30,
1990. Ecoloigcla Effects Branch.  Environmental Fate and Effects Branch.
 United States Environmental Protection Agency.  

Rexrode, M., Urban, D., & Akerman, J. 1989a. Proposed Section 18
(Kansas) for use of esfenvalerate on Winter Wheat. Memorandum From to D.
Stubbs.  June 23, 1989. Ecological Effects Branch.  Hazard Evaluation
Division.  Office of Pesticide Programs.  United States Environmental
Protection Agency.  

Rexrode, M., Urban, D., & Akerman, J. 1989b. Proposed Section 18
(Minnesota) for use of esfenvalerate on small grains and conservation
reserve for grasshopper control. Memorandum From to D. Stubbs.  July 14,
1989. Ecological Effects Branch.  Hazard Evaluation Division.  Office of
Pesticide Programs.  United States Environmental Protection Agency.  

Rexrode, M., Urban, D., & Akerman, J. 1989c. Proposed Section 18 (South
Dakota) for use of esfenvalerate on Winter Wheat. Memorandum From to D.
Stubbs.  May 16, 1989. Ecological Effects Branch.  Hazard Evaluation
Division.  United States Environmental Protection Agency.  

Rexrode, M., Urban, D., & Akerman, J. 1989d. Proposed Section 18 for use
of esfenvalerate on Wheat and Barley. Memorandum From to D. Stubbs.  May
16, 1989. Ecological Effects Branch.  Hazard Evaluation Division. 
Office of Pesticide Programs.  United States Environmental Protection
Agency.  

Rexrode, M., Urban, D., & Cook, N. J. 1989. Proposed Section 3
Registration of Various Uses (Some of which are on sister Pydrin label).
 Completely new uses are:  cranberries, blueberries, related
bushberries, okra (Florida only), and turnips. Memorandum From to G.
LaRocca.  January 27, 1989. Ecological Effects Branch.  Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection Agency.  

Samsoe-Peterson, L., K., G., Madsen, T., Mogensen, B. B., Lassen, K.,
Skjernov, K., et al. 2001. Fate and effects of esfenvalerate in
agricultural ponds. Environmental Toxicology and Chemistry, 20(7),
1570-1578.

Solomon, K. R., Giddings, J. M., & Maund, S. J. 2001. Probabilistic risk
assessment of cotton pyrethroids:I.  Distributional analyses of
laboratory aquatic toxicity data. Environmental Toxicology and
Chemistry, 20(3), 652-659.

Toscano, N. C., Sances, F. V., Johnson, M. W., & LaPre, L. F. 1982.
Effect of various pesticides on lettuce physiology and yield.  ECOTOX
reference # 41092. Journal of Economic Entomology, 75, 738-741.

Urban, D. 1992. Possible Crisis Declaration by the State of Texas for
the Use of ASANA XL on Sorghum. Memorandum From D. Urban to B. Cool. 
March 26, 1992. Ecological Effects Branch.  Environmental Fate and
Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection Agency.  

USEPA. (1998). Guidelines for Ecological Risk Assessment, United States
Environmental Protection Agency (USEPA). Washington, D.C.: Government
Printing Office.  Available at   HYPERLINK
"http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=12460" 
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=12460  (Accessed
June 19, 2009).

USEPA. 1999. FIFRA Scientific Advisory Panel Meeting, February 23, 1999
held ad the Holiday Inn Hotel, Arlington, Virginia. S. R. N. 99-03A.
March 25, 1999. Office of Pesticide Programs. Available at   HYPERLINK
"http://www.epa.gov/scipoly/sap/meetings/1999/022399_mtg.htm#materials" 
http://www.epa.gov/scipoly/sap/meetings/1999/022399_mtg.htm#materials 
(Accessed June 26, 2009).

USEPA. 2000. Methods for Measuring the Toxicity and Bioaccumulation of
Sediment-associated Contaminants with Freshwater Invertebrates.  Second
Edition. E. 600/R-99/064. March 2000. Office of Research and
Development.  Office of Science and Technology.  Office of Water. United
States Environmental Protection Agency. Available at   HYPERLINK
"http://www.epa.gov/waterscience/cs/library/freshmanual.pdf" 
http://www.epa.gov/waterscience/cs/library/freshmanual.pdf  (Accessed
October 29, 2009).

USEPA. 2001. Method for Assessing the Chronic Toxicity of Marine and
Estuarine Sediment-associated Contaminants with the Amphipod
Leptocheirus plumulosus.  First Edition. E. 600/R-01/020. March 2001.
Office of Research and Development.  Office of Science and Technology. 
United States Environmental Protection Agency.  Engineering Research and
Development Center of U.S. Army Corps of Engineers. Available at  
HYPERLINK
"http://www.epa.gov/waterscience/cs/library/guidancemanual.pdf" 
http://www.epa.gov/waterscience/cs/library/guidancemanual.pdf  (Accessed
October 29, 2009).

USEPA. 2003. Technical basis for the derivation of equilibrium
partitioning sediment benchmarks (ESBs) for the protection of benthic
organisms: Nonionic organics (draft). Office of Research and
Development.  United States Environmnetal Protection Agency. 

USEPA. (2004). Overview of the Ecological Risk Assessment Process in the
Office of Pesticide Programs, United States Environmental Protection
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at   HYPERLINK
"http://www.epa.gov/espp/consultation/ecorisk-overview.pdf" 
http://www.epa.gov/espp/consultation/ecorisk-overview.pdf  (Accessed
June 19, 2009).

USEPA. (2009a). Draft Science Polciy Paper:  Proposed Common Mechanisms
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Environmental Proteciton Agency. Washington, D.C.  

USEPA. (2009b). ECOTOXicology Database, United States Environmental
Protection Agency (USEPA).  Available at   HYPERLINK
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June 19, 2009).

USFWS/NMFS. (1998). Endangered Species Consultation Handbook: Procedures
for Conducting Consultation and Conference Activities Under Section 7 of
the Endangered Species Act.  Final Draft, United States Fish and
Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS).
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"http://www.fws.gov/endangered/consultations/s7hndbk/s7hndbk.htm" 
http://www.fws.gov/endangered/consultations/s7hndbk/s7hndbk.htm 
(Accessed June 19, 2009).

Vaughan, A. W., Cook, N. J., & Slimak, M. W. 1987. Esfenvalerate: 
Proposed Section 18 for Use on Cranberries. Memorandum From to D.
Stubbs.  June 29, 1987. Ecological Effects Branch.  Hazard Evaluation
Division.  Office of Pesticide Programs.  United States Environmental
Protection Agency.  

Vaughan, A. W., Maciorowski, A. F., & Cook, N. J. 1994. Request from the
State of California for an Emergency Exemption (Section 18) for the use
of ASANA XL to Control Granulate Cutworm on Sugarbeets. Memorandum From
A. W. Vaughan, A. F. Maciorowski & N. J. Cook to Registration Division. 
July 20, 1994. Ecological Effects Branch.  Environmental Fate and
Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection Agency.  

Weston, D. P., You, J., & Lydy, M. J. 2004. Distribution and toxicity of
sediment-associated pesticides in agriculture-dominated water bodies of
California’s Central Valley. Environmental Science and Technology, 38,
2752-2759.

Williams, S., & Hogarth, W. 2004. Letter providing an evaluation by the
U.S. Fish and Wildlife Service and National Marine Fisheries Service of
an approach to assessing the ecological risks of pesticide products.
Memorandum From to S. Hazen.  January 26, 2004.  United States Fish and
Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS).  

 

Submitted Fate Studies

161-1 Hydrolysis

MRID	Citation Reference

40999301	Lee, P.W. Hydrolysis of Chlorophenol c14 DPX-GB800 in Buffer
Solutions pH 5,7,9

161-2       Photodegradation-water

MRID	Citation Reference

40443801	Stevenson, I. (1987) Photodegradation of (Chlorophenyl
(U)-(Carbon 14)(DPX-GB800 in Water at pH 5: Laboratory Project ID:
AMR-868- 87. Unpublished study prepared by E.I. du Pont de Nemours &
Co., Inc. 37 p. 

161-3       Photodegradation-soil

MRID	Citation Reference

41728502	Castle, S.; Shepler, K.; Ruzo, L. (1990) Photodegradation of
?carbon 14|Esfenvalerate in/on Soil Surface by Natural Sunlight: Lab
Project Number: 257W: AMR-1798-90. Unpublished study pre- pared by
Pharmacology and Toxicology Research Lab. 53 p. 

41728501	Castle, S. 1990 Photodegradation in/on Soil Surface by Natural
Sunlight

162-2       Anaerobic soil metabolism

MRID	Citation Reference

42396801	Gaddamidi, V.; Bookhart, S. (1992) Anaerobic Soil Metabolism of
Esfenvalerate: Lab Project Number: AMR 2075-91. Unpublished study
prepared by E.I. du Pont de Nemours and Co. 52 p. 

163-1       Leach/adsorp/desorption

MRID	Citation Reference

45555102	Ohm, M. (2001) Adsorption/Desorption of (Carbon
14)-Esfenvalerate at a Single Concentration in Six Soils: Lab Project
Number: DUPONT-3438. Unpublished study prepared by E.I. du Pont de
Nemours and Company. 44 p. 

42350201	Merrit, R.L. Leaching Studies

164-1       Terrestrial field dissipation

MRID	Citation Reference

41520301	Schneiders, G. (1989) Field Soil Dissipation Studies with Asana
and Pydrin Insecticides: Lab Project Number: AMR-1555-89. Unpublished
study prepared by E.I. du Pont de Nemours & Co.; and Shell Development
Co. 278 p. 

41728501	Lee, P. (1990) Field Soil Dissipation of Esfenvalerate--A 1990
Study: Lab Project Number: AMR-1711-90. Unpublished study prepared by
E.I. du Pont de Nemours and Co. 34 p. 

165-4       Bioaccumulation in fish

MRID	Citation Reference

41637701	Lee, P. (1990) Bioaccumulation of Fenvalerate in Fish: Lab
Project Number: AMR-1827-90. Unpublished study prepared by E. I. du Pont
de Nemours and Co. in association with Sumitomo Chemical Co and Shell
Development Co. 142 p. 

42170501	Ohsima, M.; Mikami, N. (1991) Accumulation and Metabolism of
carbon 14|-Esfenvalerate in Carp (Cyprinus carpio): Lab Project Number:
LLM-10-0031: AMR 2192-91. Unpublished study prepared by Environ. Health
Sci. Lab. (Sumitomo Chemical Co., Ltd). 53 p. 

42922401	Ohshima, M.; Schneiders, G. (1993) Accumulation and Metabolism
of (carbon 14) Esfenvalerate in Carp (Cyprinus carpio): Lab Project
Number: AMR 2192-91: LLM-10-0031. Unpublished study prepared by
Environmental Health Science Lab., Sumitomo Chemical Co., Ltd. 23 p. 

850.7100       Data reporting for environmental chemistry methods

MRID	Citation Reference

47053001	Robinson, N. (2007) Residue Analytical Method for the
Determination of Residues of Bifenthrin, Cypermethrin, Cyfluthrin,
Deltamethrin, Esfenvalerate, Fenpropathrin, Lambda-cyhalothrin and
Permethrin in Sediment. Unpublished study prepared by Syngenta Jealotts
Hill International. 185 p.

47053002	Reed, R. (2006) Laboratory Validation: Validation of the
Residue Analytical Method: Residue Analytical Method for the
Determination of Residues of Bifenthrin, Cypermethrin, Cyfluthrin,
Deltamethrin, Esfenvalerate, Fenpropathrin, Lambda - Cyhalothrin and
Permethrin in Sediment: Final Report. Project Number: MLI/06/02,
ML06/1286/PWG. Unpublished study prepared by Morse Laboratories Inc. 418
p.

Non Guideline Selections

MRID	Citation Reference

43567101	Schneiders, G. (1995) Determination of SD43775 Residues in
Crops, Animal Tissues, Soil and Water: Electron-Capture Gas
Chromatographic Method: Update of PAM Method: Supplement No. 1: Lab
Project Number: AMR/717/87: MMS/R/478/1. Unpublished study prepared by
E. I. duPont de Nemours and Co. Experimental Station. 15 p. 

45180111	Ueda, N. (2000) Aerodynamic Droplets Sizes and Destruction of
Esfenvalerate (Sumi-alpha) 10MC through the Sprayer. Unpublished study
prepared by Environmental Health Science Laboratory, Sumitomo Chemical
Co., Ltd. 14 p. 

46051301	Ritter, A.; Williams, W. (2003) Tier 2 Modeling of Pyrethroid
Compounds Exposure to Aquatic Nontarget Organisms Associated with Use on
Cotton: Final Report. Project Number: WEI/794/03. Unpublished study
prepared by Waterborne Environmental, Inc. (WEI). 180 p.

46218001	Bacey, J.; Starner, K.; Spurlock, F. (2003) FIFRA 6(a)(2)
Submission: Preliminary Results of Study #214: Monitoring the Occurrence
and Concentration of Esfenvalerate and Permethrin Pyrethroids. Project
Number: 214. Unpublished study prepared by California Dept. of Pesticide
Regulation. 33 p.

46256801	Schneiders, G. (1991) Determination of Esfenvalerate Residues
in Crops, Animal Tissue, Soil, and Water: Electron-Capture Gas
Chromatographic Method. Project Number: AMR 2155/91. Unpublished study
prepared by E.I. DuPont De NeMours And Company. 30 p.

47058601	Pearson, F. (2007) Pyrethroid Working Group (PWG) Summary of
Results from California Sediment Samples Analyzed for Pyrethroids.
Project Number: PWG/2007/001. Unpublished study prepared by Morse
Laboratories, Inc. 11 p.

47506602	Hall, L.; Killen, W.; Anderson, R. (2008) A Comparison of
Sediment Sampling Methods for Pyrethroids in Urban/Residential Sediments
of California Streams and Additional Pyrethroid Sampling in Pleasant
Grove Creek Backwater Surrogate Sites- Pyrethroid: Assessment. Project
Number: T001584/08. Unpublished study prepared by Wye Research and
Education Center. 62 p.

47506603	Hall, L.; Killen, W.; Anderson, R.; et. al. (2008) An
Assessment of Benthic Communities with Concurrent Physical Habitat,
Pyrethroid, and Metals Analysis in and Urban and Residential Stream in
California in 2006 and 2007-Pyrethroid: Assessment. Project Number:
T001523/08. Unpublished study prepared by Wye Research and Education
Center and Northern Illinois University. 229 p.

	

Submitted Effects Studies for Fenvalarate

Avian Dietary Toxicity

MRID	Citation Reference

83043	Fink, R. (1975) Final Report: Eight-day Dietary LCI50 Bobwhite
Quail: Project No. 109-105. (Unpublished study received Apr 9, 1981
under 6G1755; prepared by Truslow Farms, Inc., submitted by Shell
Chemical Co., Washington, D.C.; CDL:099983-M) 

83044	Fink, R. (1975) Final Report: Eight-day Dietary LC50 Mallard
Ducks: Project No. 109-106. (Unpublished study received Apr 9, 1981
under 6G1755; prepared by Truslow Farms, Inc., submitted by Shell
Chemical Co., Washington, D.C.; CDL:099983-N) 

41891910	Beavers, J.; Grimes, J.; Smith, G. (1991) H #18,687: A Dietary
LC50 Study with the Northern Bobwhite: Lab Project Number: 112-263 :
168-91. Unpublished study prepared by WildLife International Ltd. 26 p. 

41891911	Beavers, J.; Grimes, J.; Smith, G. (1991) H #18,687: A Dietary
LC50 Study with the Mallard: Lab Project Number: 112-264: 167-91.
Unpublished study prepared by Wildlife International Ltd. 26 p. 

Avian Reproduction

MRID	Citation Reference

37111	Beavers, J.B.; Fink, R.; Grimes, J.; et al. (1980) Final Report:
One-Generation Reproduction Study--Bobwhite Quail: Project No. 109-122.
(Unpublished study received Jun 3, 1980 under 201- 401; prepared by
Wildlife International, Ltd., submitted by Shell Chemical Co.,
Washington, D.C.; CDL:242587-B) 

37112	Beavers, J.B.; Fink, R.; Grimes, J.; et al. (1980) Final Report:
One-Generation Reproduction Study--Mallard Duck: Project No. 109-123.
(Unpublished study received Jun 3, 1980 under 201- 401; prepared by
Wildlife International, Ltd., submitted by Shell Chemical Co.,
Washington, D.C.; CDL:242587-C) 

71638	Fink, R. (1975) Final Report: One-generation Reproduction Study--
Bobwhite Quail: Project No. 109-111. (Unpublished study received Apr 9,
1981 under 6G1755; prepared by Truslow Farms, Inc., submitted by Shell
Chemical Co., Washington, D.C.; CDL: 099983-O) 

71641	Fink, R. (1975) Final Report: One-generation Reproduction Study--
Mallard Duck: Project No. 109-112. (Unpublished study received Apr 9,
1981 under 6G1755; prepared by Truslow Farms, Inc., submitted by Shell
Chemical Co., Washington, D.C.; CDL:099983-R) 

111933	Fink, R. (1975) One-generation Reproduction Study--Mallard Duck:
SD 43775: Project No. 109-112. Final rept. (Unpublished study received
Mar 8, 1976 under 201-EX-50; prepared by Truslow Farms, Inc., submitted
by Shell Chemical Co., Washington, DC; CDL: 095407-O) 

121827	Fink, R. (1975) One-generation Reproduction Study--Mallard Duck:
SD 43775: Project No. 109-112. Final rept. (Unpublished study received
Oct 6, 1977 under 201-401; prepared by Truslow Farms, Inc., submitted by
Shell Chemical Co., Washington, DC; CDL: 096385-W) 

Acute Toxicity to Freshwater Fish

MRID	Citation Reference

71642	Shell Chemical Company (1975) Toxicity of the Pyrethroid
Insecticides, SD 43775 and SD 41706, to Fish. (Unpublished study
received Apr 9, 1981 under 6G1755; CDL:099983-S) 

74131	Shell Chemical Company (1975) Toxicity of the Pyrethroid
Insecticides, SD 43775 and SD 41706, to Fish. (Compilation; unpublished
study received Jan 15, 1979 under 201-401; CDL:099947-E) 

74132	Shell Oil Company (1976) Fish Toxicity Trials--SD 43775
(Technical/ Code 4-1-0-0--95% Purity): Test SD 43775-76-24. (Unpublished
study received Jan 15, 1979 under 201-401; CDL:099947-F) 

74133	Miyamoto, J.; Ohkawa, H.; Kikuchi, R. (1977) Toxicity of
Fenvalerate to Killifish in an Aquarium Containing Soil: AW-70-0052.
(Unpublished study received Jan 15, 1979 under 201-401; prepared by
Sumito Chemical Co., Ltd., Japan, submitted by Shell Chemical Co.,
Washington, D.C.; CDL:099947-G) 

74134	U.S. Fish and Wildlife Service, Fish-Pesticide Research Laboratory
(1976) Summary of Acute Toxicity: (SD 43775). (Unpublished study;
CDL:099947-H) 

74144	Miura, T.; Takahashi, R.M. (1976) Effects of a synthetic
pyrethroid, SD43775, on nontarget organisms when utilized as a mosquito
larvicide. Mosquito News 36(3):322-326. (Also In unpublished submission
received Jan 15, 1979 under 201-401; submitted by Shell Chemical Co.,
Washington, D.C.; CDL:099947-S) 

85723	Thompson, C.M.; Griffith, J.; Boudreau, P. (1980) Acute Toxicity
of SD 92459 to Bluegill Sunfish (~Lepomis macrochirus~): Static Acute
Bioassay Report #26415. (Unpublished study received Jul 1, 1981 under
201-415; prepared by Analytical Bio Chemistry Laboratories, Inc.,
submitted by Shell Chemical Co., Washington, D.C.; CDL:245691-F) 

85753	Thompson, C.M.; Griffen, J.; Boudreau, P. (1980) Acute Toxicity of
SD 92459 to Bluegill Sunfish (Lepomis macrochirus): Static Acute
Bioassay Report #26415. (Unpublished study received Oct 6, 1981 under
201-416; prepared by Analytical Bio Chemistry Laboratories, Inc.,
submitted by Shell Oil Co., Washington, D.C.; CDL:246033-F) 

100108	Shell Oil Co. (1975) SD 43775: Toxicity in Fish|. (Compilation;
unpublished study received Jan 15, 1979 under 201-401; CDL: 097755-C) 

100109	Shell Oil Co. (1976) Fish Toxicity Trials: SD 43775.
(Compilation; unpublished study received Jan 15, 1979 under 201-401;
CDL:097755-D) 

100110	Ohkawa, H.; Kikuchi, R.; Miyamoto, J. (1977) Toxicity of
Fenvalerate to killifish in an Aquarium Containing Soil: AW- 70-0052.
(Unpublished study received Jan 15, 1979 under 201- 401; prepared by
Sumitomo Chemical Co., Ltd., Japan, submitted by Shell Oil Co.,
Washington, DC; CDL:097755-E; 097083) 

100111	Julin, A. (1976) Letter sent to W. Reed dated May 13, 1976 (SD
43775: Toxicity data on Midges, Rainbow Trout & Bluegills.) (U.S. Fish
and Wildlife Service, Pesticide Research Laboratory; unpublished study;
CDL:097755-F) 

109833	Shell Chemical Co. (1975) Toxicity of the Pyrethroid
Insecticides, SD 43775 and SD 41706, to Fish. (Compilation; unpublished
study received Mar 8, 1976 under 201-EX-50; CDL:095407-P) 

121828	Chai, E.; Hughes, W. (1975) ?Toxicity of SD 43775 to Fish|.
(Unpublished study received Oct 6, 1977 under 201-401; submitted by
Shell Chemical Co., Washington, DC; CDL:096385-X) 

121829	Shell Chemical Co. (1975) Toxicity of SD 43775 and SD 41706 to
Fish|. (Compilation; unpublished study received Oct 6, 1977 under
201-401; CDL:096385-Y) 

121830	U.S. Fish and Wildlife Service, Fish-Pesticide Research
Laboratory (1975?) SD 43775: Summary of Acute Toxicity. (Unpublished
study received Oct 6, 1977 under 201-401; submitted by Shell Chemical
Co., Washington, DC; CDL:096385-AB) 

140461	U.S. Fish and Wildlife Service, Fish Pesticide Research
Laboratory (1975) Summary of Acute Toxicity of SD 43775 on Fish, Daphnia
and Chironomus|. (Unpublished study received Dec 28, 1976 under
201-EX-50; submitted by Shell Chemical Co., Washington, DC;
CDL:095680-C) 

141961	Analytical Bio-Chemistry Laboratories, Inc. (1980) Acute Toxicity
of SD 43775 to Bluegill Sunfish (Lepomis macrochirus): #26416.
Unpublished study. 8 p. 

141969	Burress, R. (1980) Effects of Pydrin (Fenvalerate) Treatments on
Fish and Benthic Invertebrates in Experimental Ponds. Unpublished study
prepared by Southeastern Fish Control Laboratory. 10 p. 

141974	Ohkawa, H.; Kikuchi, R. (1977) Toxicity of Fenvalerate to
Killifish (Oryzios latipes) in an Aquarium Containing Soil. Unpublished
study prepared by Sumitomo Chemical Co. Ltd. 6 p. 

141975	Shell Development Co. (1976) Fish Toxicity Studies with SD 43775:
Test SD 43775--76-14. Unpublished study. 5 p. 

141977	Coulon, D. (1982) Toxicity of Ambush and Pydrin to Red Crawfish,
Procambarus clarkii (Girard) and Channel Catfish, Ictaluras punctatus
rafinesque in Laboratory and Field Studies and the Accumulation and
Dissipation of Associated Residues. Unpublished dissertation study
prepared by Louisiana State Univ. 56 p. 

144840	EG&G Bionomics (1983) Aquatic Ecological Effects Study of the
Aerial Application of Pydrin Insecticide to Cotton: EG&G Bionomics
Report #BW-83-1-1353. Unpublished study. 85 p. 

144841	Shell Chemical Co. (19??) [Toxic Effects of SD-43775 on the
Fathead Minnow]. Unpublished study. 8 p. 

150217	Red, J.; Nutter, W.; Neary, D.; et al (1984) Computer Simulation
of Pesticide Runoff Erambert, Quachita and Stuart Seed Orchards: Report
No. 88973. Unpublished study prepared by University of Georgia,
University of Florida and USDA Forest Service. 57 p. 

155781	Holcombe, G.; Phipps, G.; Tanner, D. (1982) The acute toxicity of
kelthane, dursban, disulfoton, pydrin, and permethrin to fathead minnows
Pimephales promelas and rainbow trout Salmo gairdneri. Environmental
Pollution 29:167-178. 

156850	Forbis, A.; Georgie, L.; Burgess, D. (1985) Acute Toxicity of MO
70616 Technical to Bluegill Sunfish (Lepomis macrochirus): Static Acute
Toxicity Report #33174. Unpublished study prepared by Analytical
Bio-Chemical Laboratories, Inc. 45 p. 

41068002	Coats, J.; O'Donnell-Jeffery, N. (1979) Toxicity of four
synthetic pyrethroid insecticides to rainbow trout. Bulletin of
Environmental Contamination and Toxicology 23:250-255. 

41068003	McLeese, D.; Metcalfe, C.; Zitko, V. (1980) Lethality of
permethrin, cypermethrin and fenvalerate to salmon, lobster and shrimp.
Bulletin of Environmental Contamination and Toxicology 25:950-955. 

41215201	Ward, G. (1984) Acute Toxicity of SD47443, Pydrin Isomer, to
the Fathead Minnow (Pimephales promelas): Proj. ID 297.0584.8002.
Unpublished study prepared by Springborn Bionomics Inc. 19 p. 

41233001	Forbis, A.; Georgie, L.; Burgess, D. (1985) Acute Toxicity of
M070616 Technical to Rainbow Trout (Salmo gairdneri): Static Acute
Toxicity Report #33175. Unpublished study prepared by E.I. du Pont de
Nemours & Co., Inc. 17 p. 

41233002	Forbis, A.; Georgie, L.; Burgess, D. (1985) Acute Toxicity of
MO 70616-3-6 1.9EC to Rainbow Trout (Salmo gairdneri): Static Acute
Toxicity Report #33177. Unpublished study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 17 p. 

41891912	Baer, K. (1991) Static, Acute, 96-Hour LC50 of DPX-Y4306-90 to
Blue gill Sunfish (Lepomis macrochirus): Lab Project Number: 322-91:
MR-9084-001. Unpublished study prepared by E.I. du Pont de Nemours and
Co. & Haskell Lab. 23 p. 

41891913	Baer, K. (1991) Static, Acute, 96-Hour LC50 of DPX-Y4306-90 to
Rainbow Trout (Oncorhynchus mykiss): Lab Project Number: 330-91: MR-
9084-001. Unpublished study prepared by E.I. du Pont de Nemours and Co.
& Haskell Lab. 23 p. 

Acute Toxicity to Freshwater Invertebrates

MRID	Citation Reference

74134	U.S. Fish and Wildlife Service, Fish-Pesticide Research Laboratory
(1976) Summary of Acute Toxicity: (SD 43775). (Unpublished study;
CDL:099947-H) 

100111	Julin, A. (1976) Letter sent to W. Reed dated May 13, 1976 (SD
43775: Toxicity data on Midges, Rainbow Trout & Bluegills.) (U.S. Fish
and Wildlife Service, Pesticide Research Laboratory; unpublished study;
CDL:097755-F) 

121830	U.S. Fish and Wildlife Service, Fish-Pesticide Research
Laboratory (1975?) SD 43775: Summary of Acute Toxicity. (Unpublished
study received Oct 6, 1977 under 201-401; submitted by Shell Chemical
Co., Washington, DC; CDL:096385-AB) 

140461	U.S. Fish and Wildlife Service, Fish Pesticide Research
Laboratory (1975) Summary of Acute Toxicity ?of SD 43775 on Fish,
Daphnia and Chironomus|. (Unpublished study received Dec 28, 1976 under
201-EX-50; submitted by Shell Chemical Co., Washington, DC;
CDL:095680-C) 

141962	Sanborn, J. (1978) Acute Toxicity of SD 43775 to Daphnia.
Unpublished study prepared by Shell Development Co, Biological Sciences
Research Center. 7 p. 

141969	Burress, R. (1980) Effects of Pydrin (Fenvalerate) Treatments on
Fish and Benthic Invertebrates in Experimental Ponds. Unpublished study
prepared by Southeastern Fish Control Laboratory. 10 p. 

141970	Anderson, R. (1982) Toxicity of Fenvalerate and permethrin to
several nontarget aquatic invertebrates. Environmental Entomology.
11(6): 1251-1257. 

141976	Crossland, N.; Bennett, D.; Kane, D.; et al. (1978) The
Dispersion and Toxic Effects of the Insecticide WL 43775 in a Pond:
Group Research Report TLGR.0077.78. Unpublished study prepared by Shell
Toxicology Laboratory (Tunstall). 22 p. 

144840	EG&G Bionomics (1983) Aquatic Ecological Effects Study of the
Aerial Application of Pydrin Insecticide to Cotton: EG&G Bionomics
Report #BW-83-1-1353. Unpublished study. 85 p. 

40444002	Hutton, D. (1987) Daphnia magna Static Acute 48-hour EC50 of
Technical Asana Insecticide: Haskell Laboratory Report No. 402-87.
Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 10
p. 

40444003	Hutton, D. (1987) Fed Daphnia magna Static Acute 48-hour EC50
of Technical Asana Insecticide: Haskell Laboratory Report No. 403- 87.
Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 10
p. 

41891914	Baer, K. (1991) Static, Acute, 96-Hour LC50 of DPX-Y4306-90 to
Daphnia magna: Lab Project Number: 355-91: MR-9084-001. Unpublished
study prepared by E.I. du Pont de Nemours and Co. & Haskell. 23 p. 

Acute Toxicity to Estuarine/Marine Organisms

MRID	Citation Reference

71645	Heitmuller, T. (1975) Acute Toxicity of SD 43775 Code 4-1-0-0
(Technical) to Eastern Oysters (Crassostrea virginica), Pink Shrimp
(Penaeus duorarum), Fiddler Crabs (Uca pugilator), and Sheepshead
Minnows (Cyprinodon variegatus). (Unpublished study received Apr 9, 1981
under 6G1755; prepared by Bionomics, EG & G, Inc., submitted by Shell
Chemical Co., Washington, D.C.; CDL:099983-V) 

71646	Heitmuller, T. (1975) Acute Toxicity of SD 43775 Code 4-1-8-1 (2-4
lb/gal EC) to Eastern Oysters (Crassostrea virginica), Pink Shrimp
(Penaeus duorarum), Fiddler Crabs (Uca pugilator), and Sheepshead
Minnows (Cyprinodon variegatus). (Unpublished study received Apr 9, 1981
under 8G1755; prepared by Bionomics, EG & G, Inc., submitted by Shell
Chemical Co., Washington, D.C.; CDL:099983-W) 

74135	Heitmuller, T. (1975) Acute Toxicity of SD 43775 Code 4-1-0-0
(Technical) to Eastern Oysters (Crassostrea virginica), Pink Shrimp
(Penaeus duorarum), Fiddler Crabs (Uca pugilator), and Sheepshead
Minnows (Cyprinodon variegatus). (Unpublished study received Jan 15,
1979 under 201-401; prepared by Bionomics--EG & G, Inc., submitted by
Shell Chemical Co., Washington, D.C.; CDL:099947-I) 

141965	Bionomics--EG&G, Inc. (1975) Acute Toxicity of SD 43775 Code
4-1-0- 0 (Technical) to Eastern Oysters (Crassostrea virginica), Pink
Shrimp (Penaeus duorarum), Fiddler Crabs (Uca pugilator), and Sheepshead
Minnows (Cyprinodon variegatus). Unpublished study 9 p. 

141966	Bionomics--EG&G, Inc. (1975) Acute Toxicity of SD 43775 Code
4-1-8- 1 to Eastern Oysters (Crassostrea virginica), Pink Shrimp
(Penaeus duorarum), Fiddler Crab (Uca pugilator), and Sheepshead Minnows
(Cyprinodon variegatus). Unpublished study. 12 p. 

141967	Borthwick, P.; Walsh, G. (1981) Initial Toxicological Assessment
of Ambush, Bolero, Bux, Dushan, Fentrifanil, Larvin, and Pydrin: Static
Acute Toxicity Tests with Selected Estuarine Algae, In- vertebrates, and
Fish: EPA-600/4-81-076. Unpublished study pre- pared by Environmental
Protection Agency, Environmental Research Laboratory. 9 p. 

141968	Tagatz, M.; Ivey, J. (1981) Effects of fenvalerate on field- and
laboratory-developed estuarine benthic communities. Bull. Environm.
Contam. Toxicol. 27:256-267. 

144839	EG&G Bionomics (1980) Acute Toxicity of SD 43775 (Technical) to
Mysid-Shrimp (Mysidopsis bahia): Project Number H91. Unpublished study.
6 p. 

Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study

MRID	Citation Reference

100117	Potter, J. (1976) Residues of 14C and SD 43775-14C in Fish Ex-
posed to SD 43775-14C: TIR-22-105-76. (Unpublished study received Jan
15, 1979 under 201-401; submitted by Shell Oil Co., Washington, DC;
CDL:097755-S; 097083) 

100120	Bionomics (1978) Residue Levels of SD 43775 in Fathead Minnows
Resulting from 168 Days Exposure to SD 43775 in Water followed by 0, 14,
28 and 56 Days of Depuration: TIR-24-609-77-B. (Un- published study
received Jan 15, 1979 under 201-401; submitted by Shell Oil Co.,
Washington, DC; CDL:097755-X) 

141963	Sanborn, J. (1978) The Effect of SD 43775 on Daphnia magna in a
Static Test System. Unpublished study prepared by Shell Development Co.,
Biological Sciences Research Center. 17 p. 

141967	Borthwick, P.; Walsh, G. (1981) Initial Toxicological Assessment
of Ambush, Bolero, Bux, Dushan, Fentrifanil, Larvin, and Pydrin: Static
Acute Toxicity Tests with Selected Estuarine Algae, In- vertebrates, and
Fish: EPA-600/4-81-076. Unpublished study pre- pared by Environmental
Protection Agency, Environmental Research Laboratory. 9 p. 

144841	Shell Chemical Co. (19??) [Toxic Effects of SD-43775 on the
Fathead Minnow]. Unpublished study. 8 p. 

40444001	Hutton, D. (1987) Chronic Toxicity of Technical Asana
Insecticide to Daphnia magna: Haskell Laboratory Report No. 589-87.
Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 21
p. 

40492301	McKee, M.; Knowles, C. (1986) Effects of fenvalerate on
biochemical parameters, survival, and reproduction. Ecotoxicology and
Environmental Safety 12:70-84. 

41068007	Hansen, D.; Goodman, L.; Moore, J.; et al. (1983) Effects of
the synthetic pyrethroid AC 222, 705, permethrin and fenvalerate on
Sheepshead minnows in early life stage toxicity tests. Environmental
Toxicology and Chemistry 2:251-258. 

41068009	Spehar, R.; Tanner, D.; Gibson, J. (1982) Effects of kelthane
and pydrin on early life stages of fathead minnows (Pimephales promelas)
and amphipods (Hyalella azteca). Aquatic Toxicology and Hazard
assessment: p. 234-244 in the papers of the Fifth Conference , ASTM STP
766, American Society for Testing and Materials Philadelphia, Pa. 

Life cycle fish

MRID	Citation Reference

74145	EG & G, Bionomics (1978) Chronic Toxicity of SD-43775 to the
Fathead Minnow (Pimephales promelas): Report #BW-78-1-018. (Unpublished
study received Jan 15, 1979 under 201-401; sub- mitted by Shell Chemical
Co., Washington, D.C.; CDL:099947-T) 

100116	E G & G, Bionomics (1978) Chronic Toxicity of SD-43755 to the
Fathead Minnow (Pimephales promelas): Report #BW-78-1-018. (Unpublished
study received Jan 15, 1979 under 201-401; submit- ted by Shell Oil Co.,
Washington, DC; CDL:097755-Q) 

121839	Sauter, S. (1977) Letter sent to J. Bishop dated Aug 25, 1977 A
summary of chronic exposure of SD-43775 to fathead minnows|.
(Unpublished study received Oct 6, 1977 under 201-401; prepared by EG &
G, Bionomics, submitted by Shell Chemical Co., Washington, DC;
CDL:096385-AO) 

144841	Shell Chemical Co. (19??) [Toxic Effects of SD-43775 on the
Fathead Minnow]. Unpublished study. 8 p. 

Aquatic org. accumulation

MRID	Citation Reference

41068009	Spehar, R.; Tanner, D.; Gibson, J. (1982) Effects of kelthane
and pydrin on early life stages of fathead minnows (Pimephales promelas)
and amphipods (Hyalella azteca). Aquatic Toxicology and Hazard
assessment: p. 234-244 in the papers of the Fifth Conference , ASTM STP
766, American Society for Testing and Materials Philadelphia, Pa. 

Simulated or Actual Field Testing

MRID	Citation Reference

71642	Shell Chemical Company (1975) Toxicity of the Pyrethroid
Insecticides, SD 43775 and SD 41706, to Fish. (Unpublished study
received Apr 9, 1981 under 6G1755; CDL:099983-S) 

74138	Bishop, J.L.; Simpson, E. (1976) SD 43775/Aquatic Wildlife Study.
(Unpublished study received Jan 15, 1979 under 201-401; submit- ted by
Shell Chemical Co., Washington, D.C.; CDL:099947-M) 

74143	Hughes, W.J.; Brown, L.L. (1976) Fish Toxicity Studies with SD
43775: Test SD 43775-76-14. (Unpublished study received Jan 15, 1979
under 201-401; submitted by Shell Chemical Co., Washington, D.C.;
CDL:099947-R) 

74144	Miura, T.; Takahashi, R.M. (1976) Effects of a synthetic
pyrethroid, SD43775, on nontarget organisms when utilized as a mosquito
larvicide. Mosquito News 36(3):322-326. (Also In unpublished submission
received Jan 15, 1979 under 201-401; submitted by Shell Chemical Co.,
Washington, D.C.; CDL:099947-S) 

121833	Hughes, W.; Brown, L. (1976) Fish Toxicity Studies with SD 43775:
Test SD 43775--76-14. (Unpublished study received Oct 6, 1977 under
201-401; submitted by Shell Chemical Co., Washington, DC; CDL:096385-AH)

140462	Comegys, G.; Metz, R.; Skelsey, J. (1976) Control of Cotton
Insects with SD 43775. (Unpublished study received Dec 28, 1976 under
201-EX-50; submitted by Shell Oil Co., Washington, DC; CDL: 095680-E) 

Submitted Effects Studies for Esfenvalerate

Avian Single Dose Oral Toxicity

MRID	Citation Reference

41698401	Campbell, S.; Hoxter., K.; Smith, G. (1990) Technical Asana: An
Acute Oral Toxicity with the Northern Bobwhite: Lab Project Number:
112-231A. Unpublished study prepared by Wildlife International Ltd. 21
p. 

Avian Dietary Toxicity

MRID	Citation Reference

41637802	Driscoll, C.; Hoxter, K.; Smith, G. (1990) Asana Technical: A
Dietary LC50 Study with the Mallard: Lab Project Number: 112-230.
Unpublished study prepared by Wildlife International Ltd. 30 p. 

41637803	Driscoll, C.; Hoxter, K.; Smith, G.; et al. (1990) Asana
Technical: A Dietary LC50 Study with the Northern Bobwhite: Lab Project
Number: 112/229. Unpublished study prepared by Wildlife Inter- national
Ltd. 26 p. 

Acute Toxicity to Freshwater Fish

MRID	Citation Reference

41215201	Ward, G. (1984) Acute Toxicity of SD47443, Pydrin Isomer, to
the Fathead Minnow (Pimephales promelas): Proj. ID 297.0584.8002.
Unpublished study prepared by Springborn Bionomics Inc. 19 p. 

41215202	Forbis, A.; Georgie, L.; Burgess, D. (1985) Acute Toxicity of
MO70616-3-6 1.9 EC to Bluegill Sunfish (Lepomis macrochirus): Static
Acute Toxicity Report #33176. Unpublished study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 17 p. 

41233001	Forbis, A.; Georgie, L.; Burgess, D. (1985) Acute Toxicity of
M070616 Technical to Rainbow Trout (Salmo gairdneri): Static Acute
Toxicity Report #33175. Unpublished study prepared by E.I. du Pont de
Nemours & Co., Inc. 17 p. 

41233002	Forbis, A.; Georgie, L.; Burgess, D. (1985) Acute Toxicity of
MO 70616-3-6 1.9EC to Rainbow Trout (Salmo gairdneri): Static Acute
Toxicity Report #33177. Unpublished study prepared by Analytical
Bio-Chemistry Laboratories, Inc. 17 p. 

43358311	Baer, K. (1994) Flow-through, Acute, 96-Hour LC50 of
DPX-YB656-82 to Rainbow Trout, Oncorhynchus mykiss: Lab Project Number:
HLR 254-94: 254-94: 9799-001. Unpublished study prepared by DuPont
Haskell Lab for Toxicology and Industrial Medicine. 35 p. 

43358312	Baer, K. (1994) Flow-through, Acute, 96-Hour LC50 of
DPX-YB656-82 to Bluegill Sunfish, Lepomis macrochirus: Revised Report:
Lab Project Number: HLR 350-94: 350-94: 9799-001. Unpublished study
prepared by DuPont Haskell Lab for Toxicology and Industrial Medicine.
37 p. 

41215201	Ward, G.S. SD47443 Pydrin Isomer Toxicity to Fathead minnow

Acute Toxicity to Freshwater Invertebrates

MRID	Citation Reference

40444002	Hutton, D. (1987) Daphnia magna Static Acute 48-hour EC50 of
Technical Asana Insecticide: Haskell Laboratory Report No. 402-87.
Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 10
p. 

40444003	Hutton, D. (1987) Fed Daphnia magna Static Acute 48-hour EC50
of Technical Asana Insecticide: Haskell Laboratory Report No. 403- 87.
Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 10
p. 

41798301	Baer, K. (1991) Static Acute 48-Hour EC50 of IN YB656-59 to
Daphnia magna: Lab Project Number: 505-90: MR-4581-803. Unpublished
study prepared by E.I. du Pont de Nemours and Co. 20 p. 

42492601	Baer, K. (1992) Static Renewal, Acute 48-Hour EC50 of
DPX-YB656-59 (Asana XL Insecticide) to Daphnia magna (Supp): Lab Project
Number: 483-92: 9581-008. Unpublished study prepared by Du Pont Haskell
Labs. 24 p. 

42492602	Baer, K. (1992) Static Renewal, Acute 48-Hour EC50 of
DPX-YB656-58 (Technical Asana Insecticide) to Daphnia magna (Supp): Lab
Project Number: 490-92: 9581-007. Unpublished study prepared by Du Pont
Haskell Labs. 25 p. 

43358313	Baer, K. (1994) Static-Renewal, Acute, 48-Hour EC50 of
DPX-YB656-82 to Daphnia magna: Revised Report: Lab Project Number: HLR
698-93: 698-93: 9581-063. Unpublished study prepared by DuPont Haskell
Lab for Toxicology and Industrial Medicine. 36 p. 

42170201	L'Empereur, K. (1991) Supplement To: Static Acute 48-Hour EC50
of IN YB656-59 to Daphnia magna: Lab Project Number: 505-90:
MR-4581-803. Unpublished study prepared by E.I. du Pont de Nemours and
Co. 12 p. 

43758313	Baer, K. DPX-YB656-82 Formulation toxicity to Daphnia magna
(44% SS Isomer)

Estuarine Organism Acute Toxicity

40228401	USEPA Gulbreeze Laboratory studies were conducted on a number
of species with Fenvelerate

Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study

MRID	Citation Reference

40414101	Surprenant, D. (1987) Chronic Toxicity of (Carbon-14)-Asana
(DPX-GB-800) to Mysid Shrimp (Mysidopsis Bahia): Report No. 87-8-2475:
Study No. 777-0186-6101-530. Unpublished study prepared by Springborn
Life Sciences, Inc. 103 p. 

40444001	Hutton, D. (1987) Chronic Toxicity of Technical Asana
Insecticide to Daphnia magna: Haskell Laboratory Report No. 589-87.
Unpublished study prepared by E. I. du Pont de Nemours and Co., Inc. 21
p. 

Simulated or Actual Field Testing

MRID	Citation Reference

41573901	Krueger, H.; Springer, T.; Jaber, M.; et al. (1990) An
Evaluation of the Impact of Esfenvalerate on Managed Aquatic Ecosystems:
Lab Proj.# AMR-1232-88. Unpublished study prepared by Wildlife
International Ltd. 830 p. 

41665601	Stanley, B.; Layton, R. (1990) An Evaluation of the Impact of
Esfenvalerate on Managed Aquatic Ecosystems: Supplement No. 1 to:
Project Number: AMR-1232-88: 112-182. Unpublished study prepared by
Wildlife International Ltd. 35 p. 

Honey bee acute contact

MRID	Citation Reference

41698402	Hoxter, K.; Smith, G. (1990) H-18,151 (Technical Asana): An
Acute Contact Toxicity Study with the Honey Bee: Lab Project Number:
112-247: 471-90. Unpublished study prepared by Wildlife International,
Ltd. 15 p. 

NON Guideline Study Selections

MRID	Citation Reference

46591505	Putt, A. (2005) Esfenvalerate - Toxicity to Midge (Chironomus
tentans) During a 10-Day Sediment Exposure. Project Number: 13656/6119.
Unpublished study prepared by Springborn Smithers Laboratories. 94 p.

46620401	Putt, A. (2005) Esfenvalerate - Toxicity to Estuarine Amphipods
(Leptocheirus plumulosus) During a 28-Day Sediment Exposure. Project
Number: 13656/6120. Unpublished study prepared by Springborn Smithers
Laboratories. 89 p.

47050502	Burr, S.; Ray, D. (2004) Structure-Activity and Interaction
Effects of 14 different Pyrethroids on Voltage-Gated Chloride Ion
Channels. Toxicological Sciences 77(2):341-346.

47543612	Fairchild, J.; La Point, T.; Schwartz, T. (1994) Effects of an
Herbicide and Insecticide Mixture in Aquatic Mesocosms. Archives of
Environmental Contamination and Toxicology 27: 527-533.

Chironomid Sediment Toxicity Test

MRID	Citation Reference

46871501	Giddings, J. (2006) Overview of Sediment Toxicity Studies with
Synthetic Pyrethroids. Project Number: 06723, 06273. Unpublished study
prepared by Compliance Services International. 62 p.

Appendix   SEQ Appendix \* ALPHABETIC  A :  Data Call In Tables

Esfenvalerate:  Acute Oral Toxicity to Passerine Species

Guideline Number: 850.2100

Study Title:  Avian Oral Toxicity (Passerine Species with TGAI)

Rationale for Requiring the Data

No data for passerine species are available.  Avian acute data indicate
that esfenvalerate is highly toxic to the bobwhite quail, toxicity data
for game birds may not reflect risks to passerine birds which have been
identified to be more sensitive to pesticides in some cases than the
Bobwhite Quail or Mallard Duck.  Therefore, additional data are needed
to accurately assess risks to these species.  Specifically, data are
required on one passerine species in addition to either one waterfowl
species or one upland game bird species for terrestrial, aquatic,
forestry, and residential outdoor uses. 

 

Practical Utility of the Data

How will the data be used?  

The passerine acute toxicity data are needed for future regulatory
decisions, and for endangered species assessments.  The data will allow
the Agency to better assess the risks to these organisms, including the
likelihood of potential risks to endangered species, either by direct
effects or by indirect effects such as reducing food sources to listed
predators and scavengers.  Results of this study would be used to
calculate acute risks to passerine species from exposure to
esfenvalerate and to identify whether current labeling is appropriate
and whether further mitigation is necessary.

 

How could the data impact the Agency’s future decision-making?

If the data indicate that esfenvalerate poses a significant acute risk
to upland game or passerine birds, the Agency may explore additional
decision options to minimize the risk of esfenvalerate to these species.
 If future endangered species risk assessments are performed without
these data, the Agency would have to assume that esfenvalerate "may
affect" passerine birds directly and other endangered species indirectly
through loss of prey.  The lack of these data will limit the flexibility
the Agency and registrants have in complying with the Endangered Species
Act and could result in unnecessary use restrictions, and the use of
esfenvalerate may need to be restricted in areas where endangered
species occur unless these data are provided.

Esfenvalerate:  Chronic Toxicity for Avian Species

Guideline Number:  850.2300

Study Title:   Avian Reproduction Study (Upland Game Bird and Waterfowl
with TGAI)

Rationale for Requiring the Data

No acceptable data on reproductive toxicity to birds have been
submitted.   A chronic risk assessment for birds is needed based on
esfenvalerate’s use patterns and potential impact on birds.  The avian
reproduction toxicity study is justified for esfenvalerate because 1)
the avian reproduction studies for waterfowl and upland game bird
species are standard data requirements for all outdoor terrestrial use
patterns, 2) evidence of chronic toxicity to mammals indicates possible
chronic toxicity in birds, and 3) esfenvalerate use pattern indicates
that chronic exposure is likely.  

Practical Utility of the Data

How did the Agency make its re-registration decision without this data? 

An ecological risk assessment was not conducted for the re-registration
decision for esfenvalerate.

How will the data be used?  

The avian reproduction studies are needed for future regulatory
decisions and for an endangered species assessment in particular.  The
data would allow the Agency to quantify the potential for chronic risk,
as measured by effects on reproduction and hatchling survival, from the
use of esfenvalerate.  Results of this study would be used to calculate
risks to avian reproduction from dietary exposure to esfenvalerate at
labeled use rates and to identify what, if any, label language is needed
to mitigate identified risks.

How could the data impact the Agency’s future decision-making?

If future endangered species risk assessments are performed without
these data, the Agency would have to assume that esfenvalerate "may
affect" birds directly (and endangered species from other taxa
indirectly), and use of esfenvalerate might need to be restricted in
areas where endangered species could be exposed.  The lack of these data
will limit the flexibility the Agency and registrants have in coming
into compliance with the Endangered Species Act and could result in use
restrictions for esfenvalerate which are unnecessarily severe.

Esfenvalerate:  Acute and Chronic Toxicity to Freshwater Fish

Guideline Number:  850.1075

Study Title:  Acute Toxicity Freshwater Fish (Coldwater and Warmwater
Fish with TGAI)

Guideline Number:  850.1500

Study Title:  Freshwater Fish Full Lifecycle (for freshwater species
with acute data with TGAI)

Guideline Number:  850.1400

Study Title:  Freshwater Fish Early Life stage (for one species with
acute data and TGAI, data from the fish full lifecycle may be used to
fulfill this guideline)

Rationale for Requiring the Data

There is insufficient data available to assess the potential mortality
risk of esfenvalerate to freshwater fish.  The exposure concentrations
in submitted acute and chronic studies are uncertain due to highly
variable measured concentrations or concentrations were not measured. 
Acute data are required for one warmwater and one coldwater species.  A
fish full lifecycle study is required for one fish that also has acute
data.  Data may be collected in the fish full lifecycle study to satisfy
the fish early life stage guideline as well.  Given that fecundity
endpoints are highly variable, the lab that conducts the test should
ensure that an appropriate number of replicates be used.  Usually for
nonparametric tests, a minimum of four replicates are required.    

Requested data would allow EPA to estimate acute and chronic risks to
freshwater fish, including defining an action area for endangered
species.  Risk mitigation strategies (e.g., determining the maximum
esfenvalerate application rate that results in an RQ below the LOC)
cannot be evaluated without these data.  

Practical Utility of the Data 

How did the Agency make a re-registration decision without these data?  

An ecological risk assessment was not completed with the reregistration
decision for esfenvalerate.

How will the data be used?  

These data are needed for a registration review decision and for an
endangered species assessment, which will be conducted as part of that
decision. The data would allow the Agency to determine acute and chronic
risk to freshwater fish from exposure to esfenvalerate.  The effects
data would be used to determine the likelihood that the acute and
chronic risks can potentially impact aquatic communities, either by
direct effects or by indirect effects on other organisms by reducing
their food sources.  

How could the data impact the Agency’s future decision-making?

Risk assessment and mitigation strategies (e.g., determining the maximum
esfenvalerate application rate that results in Risk Quotients (RQs)
below the Level of Concern (LOC)) cannot be evaluated without these
data.  If future endangered species risk assessments are performed
without these data, the Agency would have to assume that esfenvalerate
“may affect” endangered freshwater fish directly (and endangered
species from other taxa indirectly), and use of esfenvalerate might need
to be restricted in areas where endangered species could be exposed. 
The lack of these data will limit the flexibility the Agency and
registrants have in coming into compliance with the Endangered Species
Act and could result in use restrictions for esfenvalerate which are
unnecessarily severe.

Esfenvalerate:  Acute and Chronic Toxicity to Estuarine/Marine Organisms

Guideline Number: 850.1075

Study Title:  Estuarine/Marine Fish Acute Toxicity Study (TGAI and TEP)

Guideline Number:  850.1500

Study Title:  Estuarine/Marine Fish Full Life Cycle (TGAI)

Guideline Number 850.1400

Study Title:  Estuarine/Marine Fish Early Life Stage (TGAI)

Guideline Number:  850.1025, 850.1035, 850.1045, 850.1055

Study Title:   Acute Toxicity Estuarine/Marine Invertebrate Toxicity
Study  for Mollusk and Another Invertebrate (TGAI and TEP)

Guideline Number: 850.1350

Study Title:  Estuarine/Marine Invertebrate Life Cycle for One Species
(TGAI)

Guideline Number: Not Available

for one species using the SS-isomer and the TGAI and for the TEP because
the maximum EEC is expected to be ≥ the 0.5 × LC50 based on the
freshwater acute toxicity data (MRID 43358311).

 EEC (0.65 µg/L) ≥ 0.1 × LC50 (0.31 µg/L)   ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) . 
Given that fecundity endpoints are highly variable, the lab that
conducts the test should ensure that an appropriate number of replicates
be used.  Usually for nonparametric tests, a minimum of four replicates
are required.  A fish early life cycle test was not requested because
these data will be available from the full lifecycle test.  

Acute toxicity data are needed for the mollusk and an estuarine/marine
invertebrate for the TGAI and TEP because the data available cannot be
used quantitatively and these are standard data requirements when
estuarine/marine exposure may occur.  

An estuarine/marine invertebrate life cycle study is needed because the
acute LC50 is expected to be less than 1 mg/L based on
supplemental-qualitative data (MRID 40228401, 144839).  Additionally,
chronic exposure is likely to occur.

Finally, an estuarine/marine whole sediment test (28-day exposure)
examining survival, growth, and reproduction is needed for amphipods
(Leptocheirus plumulosus).  This study was requested to understand
sediment toxicity for all pyrethroids and in response to an 1999 SAP on
pyrethroids   ADDIN EN.CITE
<EndNote><Cite><Author>USEPA</Author><Year>1999</Year><RecNum>42</RecNum
><DisplayText>(USEPA,
1999)</DisplayText><record><rec-number>42</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">42</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">401</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>USEPA,</author></a
uthors><secondary-authors><author>SAP Report No.
99-03A</author></secondary-authors></contributors><titles><title>FIFRA
Scientific Advisory Panel Meeting, February 23, 1999 held ad the Holiday
Inn Hotel, Arlington, Virginia.</title><secondary-title>March 25,
1999</secondary-title><tertiary-title>Office of Pesticide
Programs</tertiary-title></titles><keywords><keyword>Pyrethroid,
esfenvalerate</keyword></keywords><dates><year>1999</year><pub-dates><da
te>March 25, 1999</date></pub-dates></dates><label>Scientific Advisory
Panel</label><urls><related-urls><url>http://www.epa.gov/scipoly/sap/mee
tings/1999/022399_mtg.htm#materials</url></related-urls></urls><access-d
ate>June 26, 2009</access-date></record></Cite></EndNote> (USEPA, 1999)
.  The submitted study did not evaluate reproductive and behavioral
endpoints as recommended by current sediment recommendations.

Toxicity data for the California Grunion, Sheepshead minnow, Atlantic
silverside, Mysid shrimp, and pink shrimp are available; however, not
enough information is provided on the studies to use the results
quantitatively.  

Data on acute and chronic toxicity to estuarine/marine organisms are
needed because acute and chronic exposure of estuarine/marine species to
esfenvalerate may occur with the uses of esfenvalerate.  There is
insufficient data available to assess the potential risk of
esfenvalerate to estuarine/marine organisms.  Esfenvalerate has a
variety of agricultural, commercial, and residential uses and residues
are expected to reach freshwater and estuarine/marine aquatic
environments.  

The requested data would allow EPA to estimate acute and chronic risks
to estuarine/marine mollusks, invertebrates, and fish, including in
defining an action area for endangered species.  Risk mitigation
strategies (e.g., determining the maximum esfenvalerate application rate
or other risk mitigation measures that results in an RQ below the LOC)
cannot be evaluated without these data. 

Practical Utility of the Data 

How did the Agency make a re-registration decision without these data?  

An ecological risk assessment was not completed with the re-registration
decision for esfenvalerate.

How will the data be used?  

These data are needed for a registration review decision and for an
endangered species assessment, which will be conducted as part of that
decision.  The data would allow the Agency to determine acute and
chronic risk to estuarine/marine organisms from exposure to
esfenvalerate.  The effects data would be used to determine the
likelihood that exposure to esfenvalerate can potentially impact aquatic
communities, either by direct effects or by indirect effects on other
organisms by reducing their food sources.  Additionally, endpoints may
be used to estimate chronic toxicity to other estuarine/marine organisms
with acute toxicity data using an acute-to-chronic ratio. 

How could the data impact the Agency’s future decision-making?

Risk assessment and mitigation strategies (e.g., determining the maximum
esfenvalerate application rate and mitigation measures would result in
Risk Quotients (RQs) below the Level of Concern (LOC)) cannot be
evaluated without these data.  If future endangered species risk
assessments are performed without these data, the Agency would have to
assume that esfenvalerate “may affect” endangered saltwater
mollusks, invertebrates, and fish directly (and endangered species from
other taxa indirectly), and use of esfenvalerate might need to be
restricted in areas where endangered species could be exposed.  The lack
of these data will limit the flexibility the Agency and registrants have
in coming into compliance with the Endangered Species Act and could
result in use restrictions for esfenvalerate which are unnecessarily
severe.

Esfenvalerate:  Acute and Chronic Toxicity to Freshwater Invertebrates

Guideline Number: 850.1010

Study Title:  Freshwater Invertebrate Acute Toxicity (TEP)

Guideline Number:  Not Available

maximum EEC≥0.5 LC50, or the end product enhances toxicity.  Data are
needed for one species using the SS-isomer and a representative TEP
because the maximum EEC (3.9 µg/L) is expected to be ≥ the 0.5 ×
LC50 (0.049 µg/L)   ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) . 
Data will be used to evaluate acute risk to freshwater invertebrates
exposed to esfenvalerate.  

 ≥3 or the KOC≥1000 L/kg.  Data are needed for freshwater
invertebrates because:

aerobic soil half-lives   ADDIN EN.CITE <EndNote><Cite><Author>MRID
146578</Author><Year>1992</Year><RecNum>125</RecNum><DisplayText>(MRID
146578,
1992)</DisplayText><record><rec-number>125</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">125</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
146578,</author></authors><secondary-authors><author>Lee,
P.W.</author><author>Sterns, S.M.</author><author>Powell,
W.R.</author></secondary-authors></contributors><titles><title>Comparati
ve aerobic soil metabolism of SD 43775 (racemic) and SD 47443
(A-alpha)</title><secondary-title>Shell Development Company, Modesto,
CA</secondary-title></titles><number>MO-RIR-22-011-85.  Accession Number
258842</number><keywords><keyword>Esfenvalerate,
chlorpyrifos</keyword></keywords><dates><year>1992</year></dates><label>
MRID, Fate</label><urls></urls></record></Cite></EndNote> (MRID 146578,
1992)  are greater than 10 days; and

 values are ≥ 1000 L/kg   ADDIN EN.CITE
<EndNote><Cite><Author>45555102</Author><Year>2001</Year><RecNum>126</Re
cNum><DisplayText>(MRID 45555102,
2001)</DisplayText><record><rec-number>126</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">126</key></foreign-keys><re
f-type name="MRID">27</ref-type><contributors><authors><author>MRID
45555102, ,</author></authors><secondary-authors><author>Ohm,
M.</author></secondary-authors></contributors><titles><title>Adsorption/
Desorption of (Carbon 14)-esfenvalerate at a single concentration in six
soils</title></titles><number>Lab Project Number
DUPONT-3438</number><keywords><keyword>Esfenvalerate</keyword></keywords
><dates><year>2001</year></dates><pub-location>E.I. du Pont de Nemours
and Company</pub-location><label>MRID,
Fate</label><urls></urls></record></Cite></EndNote> (MRID 45555102,
2001) .  

Current EFED recommendations for freshwater sediment testing include
tests on Chironomus tentans and Hyallela azteca.

In the absence of data, toxicity will be estimated using the lowest
chronic toxicity endpoint for freshwater invertebrates in freshwater and
the estimated porewater concentrations in sediment.  This does not
consider possible exposure via ingestion and could underestimate risk
for some invertebrates where ingestion is an important exposure pathway.

The requested data would allow EPA to estimate acute and chronic risks
to freshwater invertebrates, including defining an action area for
endangered species.  Risk mitigation strategies (e.g., determining the
maximum esfenvalerate application rate that results in an RQ below the
LOC) cannot be evaluated without these data.

Practical Utility of the Data

How did the Agency make a re-registration decision without these data?  

An ecological risk assessment was not completed with the re-registration
decision for esfenvalerate.

How will the data be used? 

These data are needed for a registration review decision and for an
endangered species assessment, which will be conducted as part of that
decision. The data would allow the Agency to determine acute and chronic
risk to freshwater invertebrates from esfenvalerate in water and
sediment.  The effects data would be used to determine the likelihood
that the acute risks can potentially impact aquatic communities, either
by direct effects or by indirect effects on other organisms by reducing
their food sources.  

How could the data impact the Agency’s future decision-making?  

Risk assessment and mitigation strategies (e.g., determining the maximum
esfenvalerate application rate that results in Risk Quotients (RQs)
below the Level of Concern (LOC)) cannot be evaluated without these
data.  If future endangered species risk assessments are performed
without these data, the Agency would have to assume that esfenvalerate
“may affect” endangered freshwater invertebrates directly (and
endangered species from other taxa indirectly), and use of esfenvalerate
might need to be restricted in areas where endangered species could be
exposed.  The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for esfenvalerate which
are unnecessarily severe.

Esfenvalerate:  Toxicity to Terrestrial Plants

Guideline Number:  850.4100

Study Title:  Seedling emergence (Tier  I, TEP)

Guideline Number:  850.4150

Study Title:  Vegetative vigor (Tier I, TEP)  

Rationale for Requiring the Data

The only data on the toxicity of esfenvalerate to terrestrial plants is
available in the open literature.  Because the esfenvalerate studies in
this database differ significantly from OPP standards or are in other
ways not reliable, they are not sufficient for a quantitative assessment
of risks to terrestrial plants.  Terrestrial plants may be exposed to
esfenvalerate with spray drift.  Possible risks to terrestrial plants
cannot be evaluated without these data.

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

An ecological risk assessment was not completed with the re-registration
decision for esfenvalerate.

How will the data be used? 

These data are needed for a registration review decision and for an
endangered species assessment, which will be conducted as part of that
decision. The data would allow the Agency to determine acute and chronic
risk to terrestrial plants from exposure to esfenvalerate.  The effects
data would be used to determine the likelihood that terrestrial plants
may be injured with use of esfenvalerate, either by direct effects or by
indirect effects on other organisms.  

How could the data impact the Agency’s future decision-making?  

Risk assessment and mitigation strategies (e.g., determining the maximum
esfenvalerate application rate that results in Risk Quotients (RQs)
below the Level of Concern (LOC)) cannot be evaluated without these
data.  If future endangered species risk assessments are performed
without these data, the Agency would have to assume that esfenvalerate
“may affect” terrestrial plants directly and other terrestrial
organisms indirectly.  The lack of these data will limit the flexibility
the Agency and registrants have in coming into compliance with the
Endangered Species Act and could result in use restrictions for
esfenvalerate which are unnecessarily severe.

Esfenvalerate:  Toxicity to Aquatic Plants

Guideline Number:  850.4400

Study Title: Aquatic plant toxicity (Tier I, TEP or TGAI)  

Guideline Number:  850.5400

Study Title:  Algal Toxicity (Tier I, TEP or TGAI)

Rationale for Requiring the Data

The only data on the toxicity of esfenvalerate to aquatic plants is in
the open literature.  Because the esfenvalerate studies in the open
literature differ significantly from OPP standards or are in other ways
not reliable, they are not sufficient for a quantitative assessment of
risks to aquatic plants.  Aquatic plants may be exposed to esfenvalerate
from spray drift and runoff.  Possible risks to aquatic plants cannot be
evaluated without these data. 

Practical Utility of the Data

How did the Agency make its re-registration decision without these data?

An ecological risk assessment was not completed with the re-registration
decision for esfenvalerate.

How will the data be used? 

These data are needed for a registration review decision and for an
endangered species assessment, which will be conducted as part of that
decision.  Effects data would be used to determine the likelihood that
aquatic plants may be injured with use of esfenvalerate.  The data would
allow the Agency to evaluate potential risk to aquatic plants and
indirect risk to other taxa due to reduction in food and/or habitat.  

How could the data impact the Agency’s future decision-making?  

Risk assessment and mitigation strategies (e.g., determining the maximum
esfenvalerate application rate that results in Risk Quotients (RQs)
below the Level of Concern (LOC)) cannot be evaluated without these
data.  If future endangered species risk assessments are performed
without these data, the Agency would have to assume that esfenvalerate
use “may affect” endangered plants (and endangered species from
other taxa indirectly), and use of esfenvalerate might need to be
restricted in areas where endangered species could be exposed.  The lack
of these data will limit the flexibility the Agency and registrants have
in coming into compliance with the Endangered Species Act and could
result in use restrictions for esfenvalerate which are unnecessarily
severe.

Esfenvalerate: Aerobic Aquatic Metabolism

Guideline Number:  835.4300

Study Title:   Aerobic Aquatic Metabolism

Rationale for Requiring the Data

Aerobic aquatic metabolism studies facilitate an understanding of a
compound’s degradation in the water column or sediment under aerobic
(oxygen-rich) conditions.  These studies are generated by pesticide
interaction with microorganisms in a water/sediment system in the
laboratory.  

The hydrolysis and aerobic soil metabolism studies for esfenvalerate
indicate it may persist under aerobic aquatic conditions.  This study is
needed to quantify the persistence (half-life) under oxygenated
conditions in water/sediment systems. 

The requested data would allow EPA to refine its acute (mortality) and
chronic (growth and reproduction) risk estimates for all aquatic and
estuarine/marine organisms, and allow it to define an action area for
endangered species.  Risk mitigation strategies (e.g., determining
maximum application rate that results in an RQ below the LOC) cannot be
evaluated without these data.  

Practical Utility of the Data

 How did the Agency make its previous decisions without these data?

In previous ecological and human health risk assessments, EFED assumed
an aquatic half-life of 9 months (2 times longer than the soil
half-life) for aquatic modeling in the absence of aquatic metabolism
data. 

How will the data be used?

These data will be used to characterize the environmental fate of
esfenvalerate in water and for quantitative exposure estimation for
aquatic organisms and for drinking water for human health assessments. 
These data will be used to determine appropriate inputs for simulation
modeling in place of an assumed half-life. 

How could the data impact the Agency’s future decision-making?

Without these required data, the fate of esfenvalerate in aquatic
environments cannot be characterized.  In the absence of acceptable
data, the conservative assumptions noted above will be made.  For the
purposes of aquatic exposure modeling, aquatic metabolism rates will be
assumed to be double the corresponding soil metabolism rates. The lack
of data will limit the flexibility the Agency and registrants have in
coming into compliance with the Endangered Species Act and could result
in use restrictions for esfenvalerate which are unnecessarily severe.

Esfenvalerate: Anaerobic Aquatic Metabolism

Guideline Number:  835.4300

Study Title:   Aerobic Aquatic Metabolism

Rationale for Requiring the Data

Anaerobic aquatic metabolism studies facilitate an understanding of a
compound’s degradation in the water column or sediment under anaerobic
(oxygen-poor) conditions.  These studies are generated by pesticide
interaction with microorganisms in a water/sediment system in the
laboratory.  Esfenvalerate has an affinity to sorb to sediment and may
potentially persist in oxygen-poor sediments. 

The hydrolysis and aerobic soil metabolism studies for esfenvalerate
indicate it may persist under anaerobic aquatic conditions.  This study
is needed to quantify the persistence (half-life) under oxygen-poor
conditions in water/sediment systems. 

The requested data would allow EPA to refine its acute (mortality) and
chronic (growth and reproduction) risk estimates for all aquatic and
estuarine/marine organisms, particularly benthic organisms, and allow it
to define an action area for endangered species.  Risk mitigation
strategies (e.g., determining maximum application rate that results in
an RQ below the LOC) cannot be evaluated without these data.  

Practical Utility of the Data

How did the Agency make its previous decisions without these data?

In previous ecological risk assessments, EFED assumed an aquatic
half-life of 15 months (2 times longer than the soil half-life) for
aquatic modeling in the absence of aquatic metabolism data.  

How will the data be used?

These data will be used to characterize the environmental fate of
esfenvalerate, particularly in oxygen-poor sediments, and for
quantitative exposure estimation for benthic organisms.  These data will
be used to determine appropriate inputs for simulation modeling in place
of the assumed half-life of 15 months.

How could the data impact the Agency’s future decision-making?

Without these required data, the fate of esfenvalerate in aquatic
environments, primarily in sediments, cannot be characterized.  In the
absence of acceptable data, the conservative assumptions noted above
will be made.  For the purposes of aquatic exposure modeling, aquatic
metabolism rates will be assumed to be double the corresponding soil
metabolism rates.  The lack of data will limit the flexibility the
Agency and registrants have in coming into compliance with the
Endangered Species Act and could result in use restrictions for
esfenvalerate which are unnecessarily severe.



Appendix   SEQ Appendix \* ALPHABETIC  B :  Summary of Toxicity Data 

Table B1.  Summary of Submitted Aquatic Toxicity Data for Esfenvalerate
and Fenvalerate That May be Used Quantitatively. 

Study Type

	Test Species Genus Species 

Study Type	TGAI/ TEP

% ai Isomer

	Toxicity Endpoint (95% C.I.)

Slope

Measured/

Nominal

Expressed in terms of a.i.	Effect	MRID (Year)

Classification Date of DER 	Comments

Acute Freshwater Fish

Acute 	Rainbow Trout Oncorhynchus mykiss

 Flow through	TEP

SS-isomer

44%

All isomers 51%	96-hr LC50 = 0.070 (0.057-0.087) µg/L

Slope = 6.95 (6.23 -10.67)

NOAEL <0.0266 µg/L

Measured	Mortality	43358311 (1994) Acceptable

12/28/1994	Well water not characterized.  LOD of metals and priority
pollutants are too high compared to recommended limits.  Maximum solvent
concentration was 0.15 mL/L.  Sublethal effects observed at all
treatment levels and include erratic swimming, gasping for air, and
lying on the bottom.  Calibration curve range was 50-500 fold higher
than test concentrations but test concentrations were above the LOQ.

Acute	Bluegill Sunfish Lepomis macrochirus

Flow Through	TEP (WP)

SS-isomer

44.4%

All isomers

51%	96-hr LC50 = 0.23 (0.19-0.30) µg/L

Slope = 6.79 (3.29 – 10.29)

NOAEC <0.043µg/L

Measured	Mortality	43358312 (1994)

Acceptable

12/28/1994

	Solvent was acetone and solvent concentration was slightly higher than
0.1 mL/L for flow through tests.  Sublethal effects observed at all test
concentrations including erratic swimming, lethargic, rapid respiration,
lying on the bottom, gasping for air, vertical position at bottom of
tank, partial loss of equilibrium, and dark coloration.  Calibration
curve did not span the concentrations measured.

Acute	Bluegill Sunfish Lepomis macrochirus

Static	TEP

32%

all isomers	96-hr LC50 = 0.69 µg/L

NOAEC = 0.32 µg/L

nominal	Mortality	41215202

(1985)

Supplemental-quantitative for spray drift 

05/24/1993	Nominal based, Concentrations measured but there was
contamination of samples so only nominal concentrations could be used. 
As this is a TEP test, it may still be used quantitatively to assess
exposure to spray drift only.

Acute	 Bluegill Sunfish

Lepomis Macrochirus

Static	TEP

all isomers	96-hr LC50 = 0.47 (0.68 – 0.60) 

Nominal

Slope = 7.89

Probit Method	Mortality	85723 (1980)

Acceptable

06/25/1986	The test was conducted under static conditions and
esfenvalerate concentrations are difficult to maintain in static tests. 
However, as this is a study on the TEP, this study is acceptable.

Acute	Channel Catfish

Ictalurus punctatus

Static 	TEP (EC)

2.4 lbs ai/gallon

All	96-hr LC50 = 1.02 (0.87-1.2) µg/L	Mortality	121829 (1975)

Acceptable

10/1975	Pydrin 2.4 EC.  Xylene solvent.  One page DER.

Chronic Freshwater Fish – no quantitative studies available

Acute Estuarine/Marine Fish

Acute Freshwater Invertebrates

Acute	Water Flea Daphnia magna

Static	TGAI

All isomers

97.6	48-hr EC50 = 0.049 (0.024 – 0.082) µg/L

Slope not available

NOAEC = 0.03 µg/L

Measured	Mortality	41891914 (1991)

Acceptable

09/13/1991	Individual concentrations ranged from 17-35% nominal.

Acute	Water Flea Daphnia magna 

Static-renewal	TGAI

98.6 all isomers (82.8 ss-isomer, 15.8 other isomers	48-hr EC50 = 0.24
(0.19 – 0.30) µg/L

Slope = 3.011

NOAEC = 0.044 µg/L

measured	Mortality	42492602  (1992)

Acceptable

02/11/1993

	Water flowed through aquarium with fathead minnows before use.  Mean
measured concentrations of total isomers were 78-108% nominal
concentrations and the total organic carbon was in an acceptable range.

Chronic Freshwater Invertebrates

Chronic	Water Flea Daphnia magna

Static	TGAI

SS-isomer

98.6	NOAEL/LOAEL = 0.052/0.079 µg/L

NOAEL/LOAEL = 0.15/0.45 µg/L

48-hr EC50 = 0.9 (0.7 – 1.16) µg/L 

Measured 	Total number of young, young/day, and growth

Mortality

Mortality	40444001 (1987)

Acceptable

03/25/1988	Dissolved oxygen levels ranged from 48-90%.  Measured
concentrations ranged from 60 – 90% of nominal.  40-80% mortality
observed at 0.25 µg/L and 100% mortality observed at 0.50 µg/L.

10-d sediment exposure	Midge

Chironomus tentans

	TGAI

	46591505 (2005)

Not reviewed

	The sediment was screened for the presence of pesticides, PCBs and
toxic metals by GeoLabs, Inc. (Braintree, MA) and none of these
compounds were reported to be at concentrations that would be considered
to have an adverse impact on the test results.  The actual results of
the screening were not reported.  These results are needed so that EPA
may evaluate the results.  Measured concentrations were higher 130-160%
of nominal, indicating the sediment may have had residues of
esfenvalerate in it and controls may have been exposed to esfenvalerate.
 Dissolved oxygen concentrations were low (<2 mg/L) in some treatment
levels, mortality of controls was near 10%.

Acute Estuarine/Marine Invertebrates

Chronic	Mysid Shrimp

Mysidopsis bahia

40414101 (1987)

Not reviewed

	28-d sediment exposure	Amphipods

Leptocheirus plumulosus

46620401 (2005)

Not reviewed

	Abbreviations:  TGAI = technical grade active ingredient; TEP=typical
end use product; conc.=concentration; WP=wettable powder, EC =
emulsifiable concentrate; C.I. = confidence interval; LOD = limit of
detection; LOQ = limit of quantitation

* All toxicity endpoints are reported in percent active ingredient
(a.i.) unless otherwise stated.

Table B2.  Summary of Submitted Aquatic Toxicity Data for Esfenvalerate
and Fenvalerate That May be Used Qualitatively, Were Open Literature
Studies, or are Unacceptable. 

Study Type

	Test Species Genus Species 

Study Type	TGAI/ TEP

% ai Isomer

	Toxicity Endpoint (95% C.I.)

Slope

Measured/

Nominal

Expressed in terms of a.i.	Effect	MRID (Year)

Classification Date of DER 	Comments

Acute Freshwater Fish

Acute	Fathead Minnow Pimephales promelas

Static	TGAI

98%

all isomers	96-hr LC50 = 0.18 µg/L

NOAEC  =  0.13 µg/L

nominal	Mortality	41215201 (1984)

Supplemental-qualitative

05/24/1993	Analytical results indicated that test material was not
stable.  DO was 38-63%.  

Acute	Rainbow Trout

Salmo gairdneri Static	TEP (EC)

All isomers

32% 	96-hr LC50 = 0.51 µg/L

NOAEC  =  0.18 µg/L

nominal	Mortality	41233002 (1985)

Supplemental-qualitative

05/24/1993

	Esfenvalerate measured in solvent control.  The Table containing the
analytical results may have been from another test using the same test
material.  Percent a.i. in test material was not given in report.  Data
missing from appendix.

Acute	Rainbow Trout Salmo gairdneri Static

	TGAI

SS-isomer

NS	96-hr LC50 = 0.26 (0.20- 0.63) µg/L

Slope=5.96 (1.98-9.93)

NOAEC/LOAEC = 0.1/0.18 µg/L

Nominal	Mortality	41233001 (1985)

Supplemental-qualitative

05/24/1990

	Esfenvalerate measured in solvent control and measured concentrations
were highly variable.  The reviewer speculated that contamination
occurred during shipping.  Esfenvalerate was prepared in acetone which
causes racemization.  Part of the appendix is missing.  Some bottle caps
were loose when samples were received.  

Acute	Rainbow Trout

Oncorhynchus mykiss

Static	TGAI

All isomers

	96-hr LC50 = 1.2 (0.95-1.5) µg/L	Mortality	121830 (1976)

Supplemental-qualitative

DER amendment 	Aerated, fish were 20g, mortality data not legible. One
page DER.  Purity of the test substance was not provided.

Acute – 	Rainbow Trout

Oncorhynchus mykiss

	TGAI

95%

all isomers	96-hr LC50 > solubility	Mortality	121833 (1975)

Supplemental-qualitative

NS	One page DER. The test was conducted by the U.S. FWS in Columbia, MO.
 

Acute	Bluegill Sunfish Lepomis macrochirus Static	TGAI

All isomers

92.1%	96-hr LC50 = 1.01 µg/L	Mortality	Test No 2359

	Conducted at Harrison Lake National Fish.  Open Literature

Acute	Bluegill Sunfish Lepomis macrochirus Static	TGAI

All isomers

92.1%	96-hr LC50 = 0.63 µg/L	Mortality	Test No. 2355

	Conducted at Harrison Lake National Fish.

Acute	Bluegill Sunfish Lepomis macrochirus Static	TEP

All isomers

30%	96-hr LC50 = 4.3 µg/L	Mortality	Test No. 2360

No DER	Only one page summary available.  Conducted at Harrison Lake
National Fish.

Acute	Bluegill Sunfish Lepomis macrochirus

Static	TEP

All isomers

30%	96-hr LC50 = 4.9 µg/L	Mortality	Test No. 2354

No DER	Only one page summary available.  Conducted at Harrison Lake
National Fish.

Acute	Bluegill Sunfish

Lepomis macrochirus

Static	TGAI

All

NS	96-hr LC50 = 0.42 (0.30 – 0.59) µg/L	Mortality	121830 (1976)

Supplemental-qualitative

DER Amendment	One page DER.  Not enough information in the MRID to
evaluate study.  Purity of the test substance was not provided.  The
test was conducted under static conditions and the concentrations were
not measured.

Acute	Bluegill Sunfish

Lepomis macrochirus

Static	TGAI

95%

All isomers	96-hr-LC50 = 0.64 (0.55-0.75) µg/L	Mortality	121828 (1975)

Supplemental-qualitative

DER Amendment 	One page DER.  

Acute	Channel Catfish

Ictalurus punctatus

Static	TGAI

all isomers

95%	96-hr LC50 = 0.81 (0.68-0.97) µg/L	Mortality	71642 (1975)

Supplemental-qualitative

DER Amendment 	One page DER.  Not enough information in the MRID to
fully evaluate study.  

Acute 	Rainbow Trout Oncorhynchus mykiss

 flow through	TGAI

All isomers

97.6

Mortality	41891913 (1991)

Invalid

09/25/1991	Test concentrations were 30-72% of nominal.  The actual
concentrations to which rainbow trout were exposed is unknown. 
Mortality at all test concentrations.  Level of solvent not known.
Pretest mortality not reported. Age of test organisms not reported. 

Acute	Bluegill Sunfish Lepomis macrochirus

Static	TGAI

97.6%

all isomers

	41891912 (1991)

Invalid

09/25/1991	Test concentrations were 22-200% of nominal.  The actual
concentrations to which rainbow trout were exposed is unknown. 
Sublethal effects at all test concentrations.  Age of test organisms not
reported.

Chronic Freshwater Fish

Chronic	Fathead Minnow Pimephales promelas

Flow through	TGAI

Assumed all isomers

96%

Number of spawns per female, survival and growth of fry	Acc No. 97000
(1978)

Unacceptable

DER Amendment 

	There were difficulties in maintaining the desired test concentrations.
 Test days 42-63, measured concentration decreased as fish size and the
quantity of food introduced in the test tank increased.  The
concentration of the stock solution was doubled on day 63.  All test
concentrations were higher than the solubility and many samples had
measured concentrations below the minimum detectable level.  

Acute Estuarine/Marine Fish

Acute	Atlantic silverside

Menidia menidia

Flow-through	TGAI

100%

All isomers	96-hr LC50 = 0.31 (0.21-0.40) µg/L

Slope not available

Measured	Mortality	40228401 (1986)

Qualitative

Study Summary 

	The source of these data is a listing of estuarine/marine studies on
pesticides compiled by the USEPA (Mayer. 1986. Acute Toxicity Handbook
of Chemicals to Estuarine Organisms, Prepared for the Office of
Pesticides and Toxic Substances, Prepared by Environmental Research
Laboratory-Gulf Breeze EPAl6001X-26/23 1.).  The raw data for these
studies are not available and many of the details of the study are not
known. The study was initially classified as core   ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) .

Acute	Sheepshead minnow

Cyprinodon variegates

Flow-through	TGAI

100%

All isomers	96-hr LC50 > Solubility	Mortality	40228401 (1986)

Qualitative

Study Summary 

	The source of these data is a listing of estuarine/marine studies on
pesticides compiled by the USEPA (Mayer. 1986. Acute Toxicity Handbook
of Chemicals to Estuarine Organisms, Prepared for the Office of
Pesticides and Toxic Substances, Prepared by Environmental Research
Laboratory-Gulf Breeze EPAl6001X-26/23 1.).  The raw data for these
studies are not available and many of the details of the study are not
known. The study was initially classified as core   ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) .

Acute	California Grunion 

Leuresthes tenuis

Flow-through	TGAI

100%

All isomers	96-hr LC50 = 0.29  (0.21-0.37)

Slope not available

Measured

	Mortality	40228401 (1986)

Qualitative

Study Summary 

	The source of these data is a listing of estuarine/marine studies on
pesticides compiled by the USEPA (Mayer. 1986. Acute Toxicity Handbook
of Chemicals to Estuarine Organisms, Prepared for the Office of
Pesticides and Toxic Substances, Prepared by Environmental Research
Laboratory-Gulf Breeze EPAl6001X-26/23 1.).  The raw data for these
studies are not available and many of the details of the study are not
known. The study was initially classified as core   ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) .

Acute Freshwater Invertebrates

Acute	Water Flea

Daphnia magna

Static	TGAI

SS-isomer

98.6	48-hr LC50 = 0.9 (0.7-1.2) µg/L

Slope not specified

NOAEL/LOAEL = 0.11/0.19 µg/L

nominal	Mortality	40444002 (1987)

Supplemental-qualitative

DER amendment 	Concentrations were not measured.  This study was
originally found to be acceptable (DER 03/8/1988).  Static studies with
measured concentrations show highly variable test concentrations. 
Therefore, in order to be confident in the test concentration the
concentrations should be measured for this compound.

Acute

	Water Flea Daphnia magna Static-renewal	TEP (EC)

9.7% all isomers (8.4 ss-isomer and 1.3% other isomer)	48-hr EC50 = 0.33
µg/L

NOAEC = 0.067 µg/L

measured	Mortality	42492601 (1992) Supplemental-qualitative

05/21/1993	Water flowed through aquarium with fathead minnows before
use.  Measured concentrations of total isomers ranged from 55-84% of
nominal.

Acute	Water Flea

Daphnia magna

Static	TGAI

NS

All	48-hr EC50 < 1.6 µg/L	Mortality	121830 (1976)

Supplemental-qualitative

DER Amendment 	One page DER.  Purity of the test substance was not
provided.

Acute	Midge

Chironomus plumosus

NS	TGAI

All isomers

NS	48-hr EC50 >10 µg/L	Mortality	121830 (1976)

Supplemental-qualitative

DER Amendment	One page DER.  USFWS.  Purity of the test substance was
not provided.

Acute	Water Flea

Daphnia magna

Flow-Through	TEP

ss- isomer

8.4%	48-hr EC50 = 0.008 µg/L

measured	NA	41798301

(1991)

Supplemental-qualitative

  ADDIN EN.CITE   ADDIN EN.CITE.DATA   (Borges et al., 2008; Bryceland,
1999) 

	Unidentified contaminant and low analytical recoveries.  Racemization
was observed. Solvent DMF.  This study was reported to be supplemental
in recent risk assessments   ADDIN EN.CITE   ADDIN EN.CITE.DATA  
(Borges et al., 2008; Bryceland, 1999) .  However, the memo in 1992
indicates that Dupont agreed to repeat this study due to variable
analytical results, racemization, and possible contamination of water
(Memo to RD

02/18/1992)

Acute	Water Flea Daphnia magna	TEP/

WP

44.4% SS-isomer

51.0% all isomers

Mortality	43758313

(1994)

Unacceptable

DER Amendment 	Static-renewal.  Source of water was filtered fish tank
water. This study is invalid because of 1) contamination of 10 out of 16
initial test concentration samples; 2) addition of hexane rinsings of
beakers to final test concentration samples; 3) a calibration curve that
does not span the range of test concentrations; 4) the use of filtered,
fish tank water.

Chronic Freshwater Invertebrates

Life-Cycle	Water Flea

Daphnia magna

Static	TGAI

94% 

All isomers

	109887 (1979)

Invalid

06/25/1986	Greater than 80% mortality in controls.

Acute Estuarine/Marine Invertebrates

Acute	Mysid shrimp

Mysidopsis bahia

Static

Nominal	TGAI

All isomers

NS	96-hr LC50 = 0.038 (0.030 – 0.048) µg/L	Mortality	144839 (1980)

Not formally reviewed

	Acute	Pink Shrimp

Panaeus duorarum

Flow-through	TGAI

100%

All-isomers	96-hr LC50 = 0.84 µg/L	Mortality	40228401 (1986)

Qualitative

Study Summary 	The source of these data is a listing of estuarine/marine
studies on pesticides compiled by the USEPA (Mayer. 1986. Acute Toxicity
Handbook of Chemicals to Estuarine Organisms, Prepared for the Office of
Pesticides and Toxic Substances, Prepared by Environmental Research
Laboratory-Gulf Breeze EPAl6001X-26/23 1.).  The raw data for these
studies are not available and many of the details of the study are not
known. The study was initially classified as core   ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) .

Abbreviations:  TGAI = technical grade active ingredient; TEP=typical
end use product; conc.=concentration; WP=wettable powder, EC =
emulsifiable concentrate; C.I. = confidence interval; LOD = limit of
detection; LOQ = limit of quantitation

* All toxicity endpoints are reported in percent active ingredient
(a.i.) unless otherwise stated.

Table B3.  Summary of terrestrial toxicity data submitted for
esfenvalerate and fenvalerate that may be used quantitatively.

Study Type

	Test Species	Isomers	TGAI or TEP	Toxicity Endpoint

(95% C.I.)

Slope

Measured/ nominal	Effect	MRID (Year)

Classification, DER date or source	Comments

Mammals

Acute Oral	Laboratory Rat

Rattus norvegicus

TEP

50% a.i.	LD50 = 305 mg/kg-bw ai	Mortality	40602201

  ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) 

	Acute Oral	Laboratory Rat

Rattus norvegicus

TEP

30% a.i.	LD50 = 47.4 mg/kg-bw ai	Mortality	41199801

  ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) 

	Acute Oral	Laboratory Rat

Rattus norvegicus

TEP

24.6% a.i.	LD50 = 78.7 mg/kg-bw ai	Mortality	41820503

  ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) 

	Acute Oral	Laboratory Rat-male

Rattus norvegicus

TEP

8.4% a.i.	LD50 = 34.5 mg/kg-bw ai	Mortality	40369501

  ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) 

	Acute Oral	Laboratory Rat-male

Rattus norvegicus

TGAI

97.0	LD50 =87.2 mg/kg-bw	Mortality	00144973

Acceptable

  ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) 

	Acute Oral	Laboratory Rat

Rattus norvegicus	SS	TGAI

99.09	Estimated LD50 = 59.0 (0 to >20,000) mg/kg-bw	Mortality	46765601

Acceptable

  ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) 

	Subchronic Oral 

(90 day oral)	Laboratory Rat-female

Rattus norvegicus

TGAI

98.7	NOEL = 50 mg/kg	Neurological dysfunction	257018

257019, 257020, 00151030

  ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) 

	Subchronic Oral (90 day oral)	Laboratory Rat-female

Rattus norvegicus

TGAI

98.6	NOAEL = 125 mg/kg	Neurological dysfunction	40215601

  ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) 

Laboratory Rat

Rattus norvegicus

TGAI

98.8	Parental Systemic:  LOAEC=75 ppm ai (4.21 mg/kg-bw/day, male and
female)

NOAEC =  < 75 ppm ai

Offspring:

LOAEC=100 ppm ai (7.18 mg/kg-bw/day, female)

NOAEC = 75 ppm ai (5.56 mg/kg-bw/day, female)	43489001

Acceptable

  ADDIN EN.CITE
<EndNote><Cite><Author>Borges</Author><Year>2008</Year><RecNum>1</RecNum
><DisplayText>(Borges<style face="italic"> et al.</style>,
2008)</DisplayText><record><rec-number>1</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">1</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">362</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Borges,
Shannon</author><author>White, Katrina</author><author>Thurman,
Nelson</author></authors></contributors><titles><title>Risks of
Esfenvalerate Use to Federally Threatened California Red-Legged Frog
(Rana aurora draytonii).  Pesticide Effects
Determination</title><secondary-title>February 19,
2008</secondary-title><tertiary-title>Environmental Fate and Effects
Division, Office of Pesticide Programs. United States Environmental
Protection
Agency</tertiary-title></titles><periodical><full-title>February 19,
2008</full-title></periodical><keywords><keyword>Esfenvalerate</keyword>
</keywords><dates><year>2008</year><pub-dates><date>February 19,
2008</date></pub-dates></dates><pub-location>Washington,
D.C.</pub-location><publisher>Government Printing Office.  Washington,
D.C.</publisher><label>Endangered Species
Assessment</label><urls><related-urls><url>http://www.epa.gov/espp/litst
atus/effects/redleg-frog/index.html</url></related-urls></urls><access-d
ate>June 19, 2009</access-date><modified-date>February 19,
2008</modified-date></record></Cite></EndNote> (Borges et al., 2008) 

	Birds

Acute Oral	Bobwhite Quail (Colinus virginianus)

Age= 23 wks

bw=168-215 g

	SS-isomer	TGAI

98.6	NOAEL <125 mg/kg-bw

LD50 = 381 mg/kg-bw (125– positive infinity)

NOAEL/LOAEL = 125/250 mg/kg-bw

Nominal	Sublethal Effects

Mortality 

Mortality	41698401

(1991) Acceptable, DER 06/12/1991	No NOAEL available for sublethal
effects; however, no mortality occurred at 125 mg/kg-bw, the lowest test
level.  Sublethal effects observed include: ruffled appearance, lower
limb weakness, muscular fasciculations,  hyper-excitability, loss of
coordination, depression and reduced reaction to external stimuli,
reduction in food consumption, and head twitching.  Many birds recovered
over time.  Slope not available.  Mixed in water and corn oil.

Acute Oral	Bobwhite Quail (Colinus virginianus)

	All isomers	TGAI

97.6	LD50 >2000 mg/kg-bw

NOEC/LOEC = 125/250 mg/kg-bw

nominal	No mortality

Sublethal effects	41891909 (1991) Acceptable 

09/25/1991	Sublethal effects include hyperexcitability, agitation, lower
limb weakness, and excessive scratching.

Acute Dietary	Bobwhite Quail (Colinus virginianus)

Age = 10 days

bw = 15.9 ±0.4 g	SS-isomer	TGAI

98.6	LC50 >5620 mg/kg-diet

NOAEL/LOAEL = 1000/1780 mg/kg-diet	

Reduction in body weight	41637803 (1990) Acceptable

8/9/1991	Sublethal effects include body weight reduction, lethargy,
ruffled appearance, 

Dietary concentrations were not adjusted for purity of test substance. 
Group body weights were measured rather than individual body weights.

Acute Dietary	Mallard Duck (Anas platyrhynchos)

Age = 10 day

bw=280.2±6.4g

	SS-isomer	TGAI

98.6	LC50 = 4894 mg/kg-diet (1780 ppm - + infinity)

NOAEL = <562 mg/kg-diet

NOAEL/LOAEL = 562/1000 mg/kg-diet	Mortality

Decreased body weight

Mortality	41637802 (1990) Acceptable, DER 08/9/1991	Dose related
reduction in body weight at the 562, 1000, and 1780 mg/kg during the
exposure period when compared to control and loss of body weight at the
3160 and 5620 ppm concentrations.  There was no apparent effect on feed
consumption at the 1000 through 5620 ppm concentrations for this same
period.  Temperatures in brooding chambers were not in accordance with
SEP.  Slope not available.

Acute Dietary	Mallard Duck (Anas platyrhynchos)

Age = 10 days

	All isomers

	TGAI

97.6	LC50 = >5000 mg/kg-diet (1780 - + infinity)

NOAEL/LOAEL = 312.5/625 mg/kg-diet

No NOAEL	Mortality

Mortality

Body weight gain	41891911 (1991)

Acceptable

09/19/1991	Sublethal effects include lethargy, ruffled appearance,
depression, loss of coordination, reduced reaction to external stimuli,
prostate posture, loss of righting reflex, hyperexcitability, and
convulsions.  Decreased body weight gain and food consumption at all
test concentrations.

Acute Dietary	Bobwhite quail (Colinus virginianus)

Age = 10 days	All isomers	TGAI 

97.6	LC50  >5000 mg/kg-diet

NOEC/LOEL = 1250/2500 mg/kg-diet

Nominal	No mortality

Reductions in body weight gain	41891910 (1991)

Acceptable

09/19/1991	No mortality observed.  Sublethal effects include lethargy,
ruffled appearance, wing drop, depression, loss of coordination, reduced
reaction to sound and movement.

Terrestrial Invertebrates

Acute Contact

	Honey Bee Apis mellifera L.	SS-isomer	TGAI

98.6	48-hr LD50 = 0.017( 0.0125 – 0.025) µg/bee

NOAEL/ LOAEL= 0.00625/0.0125 µg/bee	Mortality	41698402 (1990)

Acceptable

07/01/1991	Liquid

Acute Contact	Honey Bee Apis mellifera 	All isomers	TGAI

NS	48-hr LD50 = 0.408 µg/bee	Mortality	246165 or 86066 (1981)

Acceptable

NS	Applied as dust.

Acute Contact	Honey Bee Apis mellifera	All isomers	TEP	Time not
specified in DER LD50 = 0.41 units not specified	Mortality	246165 or
86066 (1981)

Acceptable

12/11/1981	Applied as dust.

Acute Field	Honey Bee Apis mellifera	All isomers	TEP

2.4 lb EC

	86064 (1981)

Acceptable

12/11/1981	Field Study.  Bees caged with treated alfalfa foliage for
various time frames and mortality was evaluated after 24-hrs.  0.4 lb
ai/acre caused 100% mortality.

Acute Field	Honey Bee Apis mellifera	All isomers	TEP

2.4 lb/gal EC

	89065 (1981)

Acceptable 

12/11/1981	Field study where two bee colonies next to blooming alfalfa
field were evaluated after fenvalerate treatment.

Table B4.  Summary of terrestrial toxicity data submitted for
esfenvalerate and fenvalerate that may only be used qualitatively or are
unacceptable/invalid.

Study Type

	Test Species	Isomers	TGAI or TEP	Toxicity Endpoint

(95% C.I.)

Slope

Measured/ nominal	Effect	MRID (Year)

Classification, DER date or source	Comments

Birds

One Generation	Bobwhite Quail (Colinus virginianus)

	All	TGAI

Not-specified

	00037111 (1980)

Supplemental   ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) , DER 08/25/1980
Reported to be pydrin and SD43775 Technical.  Percent ai not specified. 
Only 3 test concentrations. Exposure to fenvalerate may result in
cracking of eggs; however, the effect was not great enough to be
statistically detectable. There was also some question over the amount
of fenvalerate contained in the highest treatment level (125 ppm), which
actually contained, based on samples tested, 60 – 85 ppm. An estimate
of the LOAEC and NOAEC may be determined to be 25 and <25 ppm,
respectively.  Eggshell cracking observed at all dosages, 25, 75, and
125 ppm   ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) .

One generation	Bobwhite Quail	All	TGAI

96%

	Accession No. 963-85 (1975)

Supplemental

NS	Data indicated that test birds were subject to diet deficiency during
the study.  

One generation	Mallard Duck (Anas platyrhynchos)

Age = 

Male bw  = Female bw = 

	all	TGAI

Not specified

	00037112 (1980)

Supplemental   ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) 

DER 08/25/1980	Reported to be pydrin and SD43775 Technical.  Percent
a.i. not specified.  Eggshell cracking observed at all dosages, 25, 75,
and 125 ppm   ADDIN EN.CITE
<EndNote><Cite><Author>Bryceland</Author><Year>1999</Year><RecNum>9</Rec
Num><DisplayText>(Bryceland,
1999)</DisplayText><record><rec-number>9</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">9</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">369</key></foreign-keys><ref-type name="EPA
Document">51</ref-type><contributors><authors><author>Andrew
Bryceland</author></authors></contributors><titles><title>EFED Response
to 24 C Esfenvalerate PC Code No:  109303; Case No. 066625; Submission
No. S566161; DP Barcode D258253</title><tertiary-title>Environmental
Fate and Effects Division.  Office of Pesticide Programs.  United States
Environmental Protection
Agency.</tertiary-title></titles><dates><year>1999</year></dates><urls><
/urls></record></Cite></EndNote> (Bryceland, 1999) .

Avian Reproduction	Mallard Duck

Anas platyrhynchos

	All isomers	TGAI

97%

	121827 (1975)

Supplemental

NS	2 page DER. (Acc No. 963-85)

Supplemental because of exposure being lower than that predicted in
field.

Avian Reproduction	Bobwhite Quail 

Age = 9 mos

	All isomers	TGAI

96%	NA	NA	109832 (1975)

Supplemental-qualitative

NS	Mean eggshell thickness was slightly below the normal range (0.2-0.22
mm) in controls and treatment groups.  Also percent of eggs cracked
(0.6-2.0%) was high for all groups.

Acute Field	Honey Bee Apis mellifera	All isomers	TEP

2.4 lb/gal EC

	89065 (1981)

Acceptable 

12/11/1981	Field study where two bee colonies next to blooming alfalfa
field were evaluated after fenvalerate treatment.



Appendix   SEQ Appendix \* ALPHABETIC  C :  Summary of products with
multiple active ingredients  

Table C1.  Summary of products containing esfenvalerate and other active
ingredients that may be used outdoors

Registration #	Name	Indoor/ Outdoor	Percent a.i.	Active Ingredient
Outside uses

239-2679	ORTHO ROACH, ANT AND SPIDER KILLER	Indoor and Outdoor	0.3	MGK
264	spray, spot treatment - ant trails, around doors, and windows,
garbage cans, wherever pests enter homes, under porches, patios,
surfaces that flies and mosquitoes land on

Esfenvalerate

	Prallethrin

	498-167	SPRAYPAK ANT & ROACH KILLER FORMULA 2	Indoor and Outdoor	0.06
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one	Spray, spot treatment
for flies and mosquitoes.  Around doors and windows, patios, surfaces
where insects may land

	0.05	Esfenvalerate

0.2	MGK 264

0.12	Piperonyl butoxide

	498-177	SPRAYPAK INSTUTIONAL ANT AND ROACH RESIDUAL SPRAY	Indoor and
Outdoor	0.25	MGK 264	Spray, spot treatment for flies and mosquitoes. 
Around doors and windows, patios, surfaces where insects may land

	0.03	Prallethrin

0.05	Esfenvalerate

	506-176	TAT ROACH & ANT SPRAY WITH RESIDUAL ACTION 2491	Indoor and
Outdoor	0.06	d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one	Outdoors to control
flies and mosquitoes.  Outside surfaces of window and doorframes and
other areas where pests may be present. Spray dark corners, localized
resting areas, under eaves of porches, patios, and garages.

	0.05	Esfenvalerate

0.12	Piperonyl butoxide

0.2	MGK 264

	1021-1594	EVERCIDE RESIDUAL PRESSURIZED SPRAY 2523	Indoor and Outdoor
0.06	d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one	Outdoors to control
flies and mosquitoes - Spray outside surfaces of window and door frames
as well as other areas where these pests may enter the home.  Spray dark
corners and localized resting areas such as porches, patios, garages,
and under eaves.

	0.2	MGK 264

0.12	Piperonyl butoxide

0.05	Esfenvalerate

	1021-1601	EVERCIDE RESIDUAL ANT & ROACH SPRAY 2543	Indoor and Outdoor 
0.25	MGK 264	Use only outdoors as an aid in reducing annoyance from
flies and mosquitoes.  Spray outside surfaces of window and door frames
as well as other areas where these pests may enter the home.  Also spray
dark corners and localized resting areas of porches patios, garages and
where insects congregate.

	0.03	Prallethrin

0.05	Esfenvalerate

	1021-1613	EVERCIDE WASP AND HORNET SPRAY 2577	Outdoor	0.2	Tetramethrin
spray hornet, wasp, and yellow jacket nests; ants and spiders:  spray
electric service boxes, water meter boxes, telephone boxes, along
foundation, vents sills, and ledges, ant trails, runways, and hills.  Do
not spray foliage. 

	0.031	Esfenvalerate

	1021-1635	EVERCIDE TOTAL RELEASE FOGGER 2602	Indoor and Outdoor	0.167
MGK 264	For use outdoors with Fire Ant Housing to kill fire ants. 
Activate the mound by disturbing, cover with bucket, canopy, box),
engage lever mechanism to discharge aerosol.  Leave undisturbed for 15
minutes. 1 unit treats 6000 cubic ft.  Max for fire ants is 6 oz.

	0.05	Pyrethrins

0.1	Esfenvalerate

0.1	Piperonyl butoxide

	1021-1691	EVERCIDE CRAWLING INSECT KILLER 2548	Indoor and Outdoor	0.3
MGK 264	Outdoors to control flies and mosquitoes - Spray outside
surfaces of window and door frames as well as other areas where these
pests may enter the home.  Spray dark corners and localized resting
areas such as porches, patios, garages, and under eaves.

	0.05	Esfenvalerate

0.03	Prallethrin

	1021-1697	EVERCIDE ROACH & ANT SPRAY 2622	Indoor and Outdoor	0.045
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one	Spot treatment, crack
and crevice treatment - Camp sites, decks, dog houses, drive-ins,
dumpsters, garbage cans, gazebos, outdoor eating establishments, patios,
porches, stadiums, verandas

	0.05	Esfenvalerate

0.25	MGK 264

	1021-1764	EVERCIDE WASP & HORNET SPRAY 26011	Indoor and Outdoor	0.167
MGK 264	Wasp, hornet, and yellow jacket nests. Spray nest until
saturated.

	0.1	Piperonyl butoxide

0.1	Esfenvalerate

0.05	Pyrethrins

	1021-1787	EVERCIDE O.B. RTU 28101	Indoor and outdoor	0.05	Esfenvalerate
Outdoors to control flies and mosquitoes - Spray outside surfaces of
window and door frames as well as other areas where these pests may
enter the home.  Spray dark corners and localized resting areas such as
porches, patios, garages, and under eaves. Repeat every 2 weeks as
needed.  Ant trails

	0.03	Prallethrin

	1021-1810	PYROCIDE FALCON 7452	Indoor and Outdoor	0.1	Pyriproxyfen
around structures to control insects

	0.2	Esfenvalerate

3	MGK 264

2	Piperonyl butoxide

1	Pyrethrins

	1021-1852	EVERCIDE WASP & HORNET SPRAY 26012	Outdoor	0.025	Pyrethrins
Kill insects. Spray nest until saturated.  2 second burst directly on
insect.

	0.05	Esfenvalerate

0.084	MGK 264

0.05	Piperonyl butoxide

	11715-186 (transferred from 2724-583)	SPEER RESIDUAL PRESSURIZED SPRAY
Outdoor and Indoor	0.065	d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one	Outdoors to control
flies and mosquitoes - Spray outside surfaces of window and door frames
as well as other areas where these pests may enter the home.  Spray dark
corners and localized resting areas such as porches, patios, garages,
and under eaves.

	0.05	Esfenvalerate

0.12	Piperonyl butoxide

0.2	MGK 264

0.6	Pyriproxyfen

0.04	Prallethrin

	11715-320 (transferred from 2724-673)	SPEER ANT AND ROACH KILLER II
Indoor and Outdoor	0.25	MGK 264	Outdoors to control flies and mosquitoes
- Spray outside surfaces of window and door frames as well as other
areas where these pests may enter the home.  Spray dark corners and
localized resting areas such as porches, patios, garages, and under
eaves.

	0.05	Esfenvalerate

0.03	Prallethrin

	8848-86	BLACK JACK ROACH & ANT KILLER VI	Indoor and Outdoor	0.03
Prallethrin	Outdoors to control flies and mosquitoes - Spray outside
surfaces of window and door frames as well as other areas where these
pests may enter the home.  Spray dark corners and localized resting
areas such as porches, patios, garages, and under eaves. Repeat every 2
weeks as needed.  Ant trails

	0.25	MGK 264

0.05	Esfenvalerate

	10807-191	MISTY FIRE ANT INJECTOR SPRAY II	Outdoor	0.2	Tetramethrin
Yards, parks, woodlands, playgrounds, and golf courses.  Insert injector
rod into mound, spray for 5 seconds for each 6 in diameter mound

	0.1	Esfenvalerate

	28293-196	UNICORN HOUSE AND CARPET SPRAY #6	Indoor and outdoor	0.065
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one	Outdoors to control
flies and mosquitoes - Spray outside surfaces of window and door frames
as well as other areas where these pests may enter the home.  Spray dark
corners and localized resting areas such as porches, patios, garages,
and under eaves

	0.2	MGK 264

0.05	Esfenvalerate

0.12	Piperonyl butoxide

	44446-65	CS 101 ROACH & ANT SPRAY	Indoor and Outdoor 	0.25	MGK 264
Garbage cans and dumpsters- spot  treatment, crack and crevice, ant
trails, Outdoors to control flies and mosquitoes - Spray outside
surfaces of window and door frames as well as other areas where these
pests may enter the home.  Spray dark corners and localized resting
areas such as porches, patios, garages, and under eaves

	0.05	Esfenvalerate

0.03	Prallethrin

	45385-93	CTX/CYBER BLAST	Outdoor 	0.25	MGK 264	Residual spray outdoors
for flies and mosquitoes.  Repeat treatments as necessary.

	0.05	Esfenvalerate

0.03	Prallethrin

	68543-17	BENGAL ROACH & ANT SPRAY IV	Indoor and Outdoor 	0.3	MGK 264
Spot treatment, crack and crevice, residual spray for flies and
mosquitoes

Table C2.  Summary of products containing esfenvalerate and other active
ingredients that may be used indoors only

Registration #	Name	Use Site	Percent a.i.	Active Ingredient

239-2624	HI-POWER INDOOR INSECT FOGGER FORMULA V	Indoor	0.167	MGK 264

	0.1	Piperonyl butoxide

	0.1	Esfenvalerate

	0.05	Pyrethrins

498-186	CHAMPION SPRAYON INDOOR INSECT FOGGER FORMULA 4	Indoor	1	MGK 264

	0.1	Esfenvalerate

	0.2	Tetramethrin

506-181	TAT TOTAL RELEASE WATER BASED FOGGER	Indoor	1	MGK 264

Tetramethrin

Esfenvalerate

706-105	MULTI-USE INSECTICIDE FOGGER	Indoor	0.1	Esfenvalerate

	0.05	Pyrethrins

	0.167	MGK 264

	0.1	Piperonyl butoxide

769-584	R&M FLEA & TICK FOGGER #1	Indoor	0.2	Tetramethrin

	0.1	Esfenvalerate

1021-1648	EVERCIDE TOTAL RELEASE AEROSOL 2604	Indoor	1	MGK 264

	0.1	Esfenvalerate

	0.2	Tetramethrin

1021-1656	EVERCIDE NYLAR TOTAL RELEASE AEROSOL 2644	Indoor	0.1
Esfenvalerate

	0.04	Prallethrin

	0.6	Pyriproxyfen

1021-1674	EVERCIDE TOTAL RELEASE AEROSOL 2614	Indoor	0.167	MGK 264

	0.05	Pyrethrins

	0.1	Pyriproxyfen

	0.1	Esfenvalerate

	0.1	Piperonyl butoxide

1021-1676	EVERCIDE TOTAL RELEASE AEROSOL 2615	Indoor	0.167	MGK 264

	0.1	Piperonyl butoxide

	0.1	Esfenvalerate

	0.6	Pyriproxyfen

	0.05	Pyrethrins

1021-1755	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27693	Indoor	0.05
Imiprothrin

	0.25	MGK 264

	0.05	Esfenvalerate

1021-1756	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27692	Indoors	0.075
Imiprothrin

	0.075	Esfenvalerate

	0.375	MGK 264

1021-1757	EVERCIDE RESIDUAL ROACH AND ANT SPRAY 27691	Indoors	0.1
Imiprothrin

	0.5	MGK 264

	0.1	Esfenvalerate

1021-1762	EVERCIDE RESIDUAL ROACH & ANT SPRAY 27891	Indoor	0.1
Imiprothrin

	0.5	MGK 264

	0.05	Esfenvalerate

1021-1827	EVERCIDE HOME DEFENSE 28452	Indoors	0.025	Imiprothrin

	0.025	Esfenvalerate

9444-143	CB-305 FOGGER

0.3	d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

	0.05	Esfenvalerate

9444-144	CB-405 FOGGER	Indoor	0.167	MGK 264

	0.1	Piperonyl butoxide

	0.05	Pyrethrins

	0.1	Esfenvalerate

9444-145	CB FOGGER IV	Indoor	0.2	Tetramethrin

	0.1	Esfenvalerate

9444-166	CB-405 FOGGER WB	Indoor	0.167	MGK 264

	0.05	Pyrethrins

	0.1	Esfenvalerate

	0.1	Piperonyl butoxide

9444-168	COUNTRY VET ROACH EMBARGO WITH GROWTH INHIBITOR	Indoor	0.1
Esfenvalerate

	0.6	Pyriproxyfen

	0.04	Prallethrin

11623-44	TOTAL RELEASE FOGGER III	Indoor	1	MGK 264

	0.1	Esfenvalerate

	0.2	Tetramethrin

28293-192	UNICORN HOUSE AND CARPET SPRAY #5	Indoor	0.065
d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

	0.05	Esfenvalerate

	0.12	Piperonyl butoxide

	0.2	MGK 264

11715-188 (transferred from 2724-584)	SPI TOTAL RELEASE AEROSOL FOGGER
II	 Indoor	0.3	d-trans-Chrysanthemum monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

	0.05	Esfenvalerate

11715-275 (transferred from 2724-647)	SPEER-IT FOGGER II TOTAL RELEASE
AEROSOL	Indoor	0.167	MGK 264

	0.1	Piperonyl butoxide

	0.05	Pyrethrins

	0.1	Esfenvalerate

11715-308 (transferred from 2724-662)	SPEER TOTAL RELEASE AEROSOL II
WITH NYLAR	Indoor	0.167	MGK 264

	0.1	Pyriproxyfen

	0.1	Piperonyl butoxide

	0.05	Pyrethrins

	0.1	Esfenvalerate

2724-664	SPEER TOTAL RELEASE AEROSOL III WITH NLAR	Indoor	0.1
Esfenvalerate

	0.6	Pyriproxyfen

	0.04	Prallethrin

11715-320 (transferred from 2724-673)	SPEER ANT AND ROACH KILLER II
Indoor and Outdoor	0.25	MGK 264

11715-323 (transferred from 2724-676)	SPEER-IT FOGGER IV TOTAL RELEASE
AEROSOL	Indoor	1	MGK 264

	0.2	Tetramethrin

	0.1	Esfenvalerate

Table C3.  Summary of manufacturing use products containing
esfenvalerate and other active ingredients

Registration #	Name	Percent a.i.	Active Ingredient

	1021-1575	EVERCIDE INTERMEDIATE 2491	3.01	d-trans-Chrysanthemum
monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

10	MGK 264

6	Piperonyl butoxide

2.5	Esfenvalerate

1021-1627	EVERCIDE INTERMEDIATE 2531	1.5	d-trans-Chrysanthemum
monocarboxylic ester of
dl-2-allyl-4-hydroxy-3-methyl-2-cyclopenten-1-one

8.33	MGK 264

1.67	Esfenvalerate

1021-1634	EVERCIDE CONCENTRATE 2601	6.43	MGK 264

3.86	Piperonyl butoxide

1.92	Pyrethrins

3.85	Esfenvalerate

1021-1647	EVERCIDE CONCENTRATE 2603	27.78	MGK 264

5.61	Tetramethrin

2.78	Esfenvalerate

1021-1652	EVERCIDE INTERMEDIATE 2666	10.01	Tetramethrin

1.57	Esfenvalerate

1021-1655	EVERCIDE CONCENTRATE 2625	5	Esfenvalerate

2	Prallethrin

1021-1692	EVERCIDE CONCENTRATE 2547	12	MGK 264

2	Esfenvalerate

1.2	Prallethrin

1021-1754	EVERCIDE INTERMEDIATE 2769	2.5	Imiprothrin

2.5	Esfenvalerate

12.5	MGK 264

1021-1763	EVERCIDE INTERMEDIATE 2789	2.5	Imiprothrin

1.25	Esfenvalerate

12.5	MGK 264

1021-1788	EVERCIDE CONCENTRATE 2810	2.5	Esfenvalerate

1.5	Prallethrin

1021-1826	EVERCIDE EMULSIFIABLE CONCENTRATE 2845 MUP	0.425	Imiprothrin

0.425	Esfenvalerate

1021-1690	EVERCIDE CONCENTRATE 2595	12.5	MGK 264

2.5	Esfenvalerate

1.5	Prallethrin

Appendix   SEQ Appendix \* ALPHABETIC  D .  ECOSAR (version 1.0)
Results for 4-chloro-alpha-(1-methylethyl)-benzeneacetic acid (CPIA)

	

SMILES : CC(C)C(C(=O)O)c1ccc(CL)cc1

MOL FOR: C11 H13 CL1 O2 

MOL WT : 212.68

Log Kow: 3.40  (KowWin estimate)

Melt Pt:  

Wat Sol: 116.8 mg/L  (WskowWin estimate)

ECOSAR v1.00 Class(es) Found

------------------------------

Neutral Organics-acid

                                                                   
Predicted

ECOSAR Class                 Organism            Duration  End Pt   mg/L
(ppm)

==========================  ==================  ========  ======  
==========

--> Acid moeity found: Predicted values multiplied by 10

Neutral Organics-acid      : Fish                96-hr     LC50      
96.265

Neutral Organics-acid      : Fish                14-day    LC50      
99.554

Neutral Organics-acid      : Daphnid             48-hr     LC50      
66.757

Neutral Organics-acid      : Green Algae         96-hr     EC50      
58.181

Neutral Organics-acid      : Fish                30-day    ChV       
11.015

Neutral Organics-acid      : Daphnid                       ChV        
9.660

Neutral Organics-acid      : Green Algae                   ChV       
28.073

Neutral Organics-acid      : Fish  (SW)          96-hr     LC50     
120.335 *

Neutral Organics-acid      : Mysid Shrimp        96-hr     LC50      
35.383

Neutral Organics-acid      : Fish  (SW)                    ChV       
31.333

Neutral Organics-acid      : Mysid Shrimp (SW)             ChV        
2.020

Neutral Organics-acid      : Earthworm           14-day    LC50    
2647.435 *

 Note:  * = asterisk designates: Chemical may not be soluble

        enough to measure this predicted effect.

 

Neutral Organics:

----------------

  For Fish LC50 (96-h), Daphnid LC50, Mysid: If the log Kow is greater

than 5.0, or if the compound is solid and the LC50 exceeds the water

solubility by 10X, no effects at saturation are predicted.

 

  For Fish LC50 (14-day) and Earthworm LC50: If the log Kow is greater

than 6.0, or if the compound is solid and the LC50 exceeds the water

solubility by 10X, no effects at saturation are predicted.

 

  For Green Algae Acute Toxicity Values: If the log Kow of the chemical
is

greater than 6.4, or if the compound is solid and the EC50 exceeds the
water

solubility by 10X, no effects at saturation are predicted for these
endpoints.

 For All Chronic Toxicity Values: If the log Kow of the chemical is
greater

than 8.0, or if the compound is solid and the ChV exceeds the water
solubility

by 10X, no effects at saturation are predicted for these endpoints.

 

ECOSAR v1.00 SAR Limitations:

----------------------------

Maximum LogKow: 5.0 (Fish 96-hr LC50; Daphnid LC50, Mysid LC50)

Maximum LogKow: 6.0 (Fish 14-day LC50; Earthworm LC50)

Maximum LogKow: 6.4 (Green Algae EC50)

Maximum LogKow: 8.0 (ChV)

Maximum Mol Wt: 1000

 

------------------------------------------------------------------------
------

 See Page 18 of the SAP meeting minutes   ADDIN EN.CITE
<EndNote><Cite><Author>Bucher</Author><Year>2009</Year><RecNum>244</RecN
um><DisplayText>(Bucher and Bailey,
2009)</DisplayText><record><rec-number>244</rec-number><foreign-keys><ke
y app="EN"
db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">244</key></foreign-keys><re
f-type name="EPA
Memo">2</ref-type><contributors><authors><author>Bucher, John
R.</author><author>Bailey, J.
E.</author></authors></contributors><titles><title>A Set of Scientific
Issues Being Considered by the Environmental Protection Agency
Regarding:  Evaluation of the Common Mechanism of Action of Pyrethroid
Pesticides.  SAP Minutes No. 2009-07</title></titles><edition>United
States Environmental Protection
Agency</edition><dates><year>2009</year><pub-dates><date>September 9,
2009</date></pub-dates></dates><urls><related-urls><url>http://www.epa.g
ov/scipoly/sap/meetings/2009/june/061609minutes.pdf</url></related-urls>
</urls><access-date>October 28,
2009</access-date></record></Cite></EndNote> (Bucher and Bailey, 2009) .

 In previous risk assessments, a chronic fish study on the fathead
minnow yielded a no observable adverse effect concentration (NOAEC) of 
0.21 µg/L and is reported as acceptable;  however, re-evaluation of the
study indicated that the study is unacceptable (Accession Number 97000) 
 ADDIN EN.CITE   ADDIN EN.CITE.DATA ́  (Borges et al. 2008; Bryceland
1999) .  The test concentration was not constant over time (e.g., within
20% of initial concentrations) and not measurable (e.g., concentrations
were below the method detection limit) at many times during the study. 
Additionally, the concentration of the test solution was doubled on day
63 and the lowest observable adverse effects concentration (LOAEC) was
higher than the 96-hr LC50 for the same species (MRID 41215201). 

 When the SS-isomer is used in aquatic toxicology studies it will also
undergo isomerization when placed in water.  The only way to ensure
exposure to one isomer to be able to compare the toxicity of the
different isomers to aquatic organisms would be to inject the organism. 

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<EndNote><Cite><Author>Barile</Author><Year>2004</Year><RecNum>41</RecNu
m><DisplayText>(Barile,
2004)</DisplayText><record><rec-number>41</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">41</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">400</key></foreign-keys><ref-type
name="Book">6</ref-type><contributors><authors><author>Barile, Frank
A</author></authors></contributors><titles><title>Clinical Toxicology: 
Principles and
Mechanisms</title></titles><dates><year>2004</year></dates><pub-location
>Boca Raton, FL</pub-location><publisher>CRC
Press</publisher><urls></urls></record></Cite></EndNote> (Barile, 2004)
.   In potentiation, one agent is relatively nontoxic.  Some references
indicate that for synergism to occur both chemicals must have cytotoxic
activity and the sum of effects of the two chemicals combined is greater
than the individual effects (e.g., “1+2>3”)   ADDIN EN.CITE
<EndNote><Cite><Author>Lewis</Author><Year>1998</Year><RecNum>38</RecNum
><DisplayText>(Lewis,
1998)</DisplayText><record><rec-number>38</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">38</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">397</key></foreign-keys><ref-type
name="Dictionary">52</ref-type><contributors><authors><author>Robert A.
Lewis</author></authors><secondary-authors><author>Robert A.
Lewis</author></secondary-authors></contributors><titles><title>Lewis&ap
os; Dictionary of
Toxicology</title></titles><dates><year>1998</year></dates><pub-location
>Boca Raton</pub-location><publisher>Lewis
Publishers</publisher><urls></urls></record></Cite></EndNote> (Lewis,
1998) .  Often synergism and potentiation are used interchangeably  
ADDIN EN.CITE
<EndNote><Cite><Author>Lewis</Author><Year>1998</Year><RecNum>38</RecNum
><DisplayText>(Lewis,
1998)</DisplayText><record><rec-number>38</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">38</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">397</key></foreign-keys><ref-type
name="Dictionary">52</ref-type><contributors><authors><author>Robert A.
Lewis</author></authors><secondary-authors><author>Robert A.
Lewis</author></secondary-authors></contributors><titles><title>Lewis&ap
os; Dictionary of
Toxicology</title></titles><dates><year>1998</year></dates><pub-location
>Boca Raton</pub-location><publisher>Lewis
Publishers</publisher><urls></urls></record></Cite></EndNote> (Lewis,
1998) .

 Piperonyl butoxide initially results in inhibition followed by
stimulation/induction of microsomal enzymes   ADDIN EN.CITE
<EndNote><Cite><Author>Hodgson</Author><Year>2001</Year><RecNum>40</RecN
um><DisplayText>(Hodgson and Smart,
2001)</DisplayText><record><rec-number>40</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">40</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">399</key></foreign-keys><ref-type
name="Edited Book">28</ref-type><contributors><authors><author>Hodgson,
Ernest</author><author>Smart, Robert
C</author></authors></contributors><titles><title>Introduction to
Biochemcial
Toxicology</title></titles><edition>Third</edition><dates><year>2001</ye
ar></dates><pub-location>New
York</pub-location><publisher>Wiley-Interscience</publisher><urls></urls
></record></Cite></EndNote> (Hodgson and Smart, 2001) .  It is used in
pharmacological experiments to compare therapeutical or toxicological
effects of drugs before and after metabolism.  It is known to induce
CYP2B1 and 1A2 at moderate doses and 1A1 at high does levels   ADDIN
EN.CITE
<EndNote><Cite><Author>Hodgson</Author><Year>2001</Year><RecNum>40</RecN
um><DisplayText>(Hodgson and Smart,
2001)</DisplayText><record><rec-number>40</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">40</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">399</key></foreign-keys><ref-type
name="Edited Book">28</ref-type><contributors><authors><author>Hodgson,
Ernest</author><author>Smart, Robert
C</author></authors></contributors><titles><title>Introduction to
Biochemcial
Toxicology</title></titles><edition>Third</edition><dates><year>2001</ye
ar></dates><pub-location>New
York</pub-location><publisher>Wiley-Interscience</publisher><urls></urls
></record></Cite></EndNote> (Hodgson and Smart, 2001) .  The mechanism
of induction was shown to be independent of the aryl hydrocarbon
receptor (AhR) using AhR-knockout mice   ADDIN EN.CITE
<EndNote><Cite><Author>Hodgson</Author><Year>2001</Year><RecNum>40</RecN
um><DisplayText>(Hodgson and Smart,
2001)</DisplayText><record><rec-number>40</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">40</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">399</key></foreign-keys><ref-type
name="Edited Book">28</ref-type><contributors><authors><author>Hodgson,
Ernest</author><author>Smart, Robert
C</author></authors></contributors><titles><title>Introduction to
Biochemcial
Toxicology</title></titles><edition>Third</edition><dates><year>2001</ye
ar></dates><pub-location>New
York</pub-location><publisher>Wiley-Interscience</publisher><urls></urls
></record></Cite></EndNote> (Hodgson and Smart, 2001) .

 Pyrethroids may be excreted as glycine, sulfate, glucuronide, or
glucoside conjugates   ADDIN EN.CITE
<EndNote><Cite><Author>Gibly</Author><Year>2001</Year><RecNum>39</RecNum
><DisplayText>(Gibly and Sullivan Jr.,
2001)</DisplayText><record><rec-number>39</rec-number><foreign-keys><key
app="EN" db-id="s0xer2w2o0xwx3e0a0tx0sz3zradttw529er">39</key><key
app="ENWeb"
db-id="RcJqaQrtmCQAAFU55fA">398</key></foreign-keys><ref-type name="Book
Section">5</ref-type><contributors><authors><author>Gibly, Raquel
L.</author><author>Sullivan Jr., John
B.</author></authors><secondary-authors><author>Sullivan Jr., John
B.</author><author>Krieger, Gary
R.</author></secondary-authors></contributors><titles><title>Chapter
103. Pyrethrins</title><secondary-title>Clinical Principles of
Environmental
Health</secondary-title></titles><dates><year>2001</year></dates><pub-lo
cation>Philadelphia, PA</pub-location><publisher>Lippincott Williams
&amp; Wilkins</publisher><urls></urls></record></Cite></EndNote> (Gibly
and Sullivan Jr., 2001) .

 http://www.epa.gov/oppefed1/general/databasesdescription.htm#eiis

 All chronic studies should be completed using the TGAI.

 The species tested should also have TEP data available (e.g., Rainbow
trout or bluegill sunfish).

 The study using the TEP should examine toxicity to the most sensitive
species tested with the TGAI.

 The species tested should be the species most sensitive to the TGAI,
e.g., Daphnia magna.

 The study using the TEP should examine toxicity to the most sensitive
species tested with the TGAI.

 All aquatic chronic studies should be conducted using the TGAI.

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Ingestion

Residues in Aquatic Organisms

 

Ingestion

Birds / Amphibians

Wet/dry deposition

Root uptake

Atmospheric transport

Dermal uptake/Ingestion

Ingestion

Ingestion

Ingestion

Ingestion

Soil / Ant Mounds

Exposure

Media

Mammals

Runoff

Terrestrial/riparian plants

grasses/forbs, fruit, seeds (trees, shrubs)

Habitat integrity

Reduction in primary productivity

Reduced cover

Community change

Food chain

Reduction in prey

Individual organisms

Reduced survival

Reduced growth

Reduced reproduction

Terrestrial 

insects

Birds / Terrestrial-phase amphibians / Reptiles / Mammals /
Invertebrates

Spray drift

Direct

application

Esfenvalerate applied to use site

All isomers are considered a stressor.

Attribute

Change

Receptors

Source

Stressor(s)