UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

	PC Code: 004003, 004004, 004005, 004007

	DP Barcode:  371344

MEMORANDUM

	March 9, 2010

SUBJECT:	Registration Review: Preliminary Problem Formulation for
Environmental Fate, Ecological Risk, and Endangered Species Assessments
for the Allethrins

TO:		Molly Clayton, Chemical Review Manager

Neil Anderson, Team Leader

Reregistration Branch 2, RM Team 52

Pesticide Re-evaluation Division

FROM:	Melissa Panger, Ph.D., Biologist

		Cheryl Sutton, Ph.D., Environmental Scientist

		Environmental Risk Branch 4

Environmental Fate and Effects Division

REVIEWED

 BY:		R. David Jones, Ph.D, Senior Agronomist

		Anita Pease, Senior Biologist

		Thomas M. Steeger, Ph.D., Senior Biologist

Environmental Risk Branch 4

		Environmental Fate and Effects Division

THROUGH:	Elizabeth Behl, Chief

Environmental Risk Branch 4

		Environmental Fate and Effects Division

The Environmental Fate and Effects Division (EFED) has completed the
preliminary problem formulation (attached) for the environmental fate,
ecological risk, and endangered species assessments to be conducted as
part of the Registration Review of the allethrin isomers.  Because of
the relatively limited use of the compound as an aerosol/fogger spot
treatment in residential settings, there is a low likelihood of the
compound contaminating human drinking water sources, so a drinking water
assessment will not be conducted to support a human dietary risk
assessment for the allethrins.

Allethrin isomers (allethrins) are nonsystemic insecticides and
acaricides that are Type I pyrethroids.  The allethrins refer to several
particular mixtures of the stereoisomers of the chrysanthemic acid ester
of allethrolone. Those mixtures include bioallethrin (also referred to
as d-trans allethrin; PC Code: 004003; 584-79-2226), esbiothrin [PC
Code: 004007 (formerly 004003/004004)], esbiol (also referred to as
s-bioallethrin; PC Code: 004004; CAS 28434-00-6), and pynamin forte (PC
Code: 004005; CAS 584-79-2).  The ‘allethrins’ also include
allethrin (PC Code: 004001) and allethrin coil (004002); however, all
uses of allethrin and allethrin coil have been withdrawn or cancelled.
Therefore, this problem formulation focuses on bioallethrin, esbiothrin,
esbiol, and pynamin forte.

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 allethrins and their degradates.  It also
describes the preliminary ecological risk hypothesis and analysis plan
for evaluating and characterizing risk to non-target species and the
environment in support of the registration review of the allethrins.
This document also recommends studies that should be included in a data
call-in (DCI) to address uncertainties surrounding the environmental
fate and potential ecological effects of the allethrins.  The
determination of data gaps and the resulting DCI is based on OPP’s
expectation that the uses will not expand beyond the limited
spot-treatments in residential settings.  However, if the use were to
expand, the data needs would also.

  SEQ CHAPTER \h \r 1

Problem Formulation for the Environmental Fate, Ecological Risk, and
Endangered Species Assessments in Support of the Registration Review of
the Allethrins

Prepared by:

Melissa Panger, Ph.D., Biologist

Cheryl Sutton, Ph.D., Environmental Scientist	U. S. Environmental
Protection Agency

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch IV

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460

Reviewed by:

Anita Pease, Senior Biologist

R. David Jones, Senior Agronomist

Elizabeth Behl, Branch Chief

March 9, 2010

Table of Contents

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc254613126"  1.  Purpose
PAGEREF _Toc254613126 \h  5

  HYPERLINK \l "_Toc254613127"  2.  Problem Formulation	  PAGEREF
_Toc254613127 \h  5

  HYPERLINK \l "_Toc254613128"  2.1.  Nature of Regulatory Action
PAGEREF _Toc254613128 \h  5

  HYPERLINK \l "_Toc254613129"  2.2.  Previous Assessments	  PAGEREF
_Toc254613129 \h  6

  HYPERLINK \l "_Toc254613130"  2.2.1.  Ecological Risk Assessments
PAGEREF _Toc254613130 \h  6

  HYPERLINK \l "_Toc254613131"  2.2.2.  Drinking Water Exposure
Assessments	  PAGEREF _Toc254613131 \h  8

  HYPERLINK \l "_Toc254613132"  3.  Stressor Source and Distribution
PAGEREF _Toc254613132 \h  8

  HYPERLINK \l "_Toc254613133"  3.1.  Mechanism of Action	  PAGEREF
_Toc254613133 \h  9

  HYPERLINK \l "_Toc254613134"  3.2.  Overview of Pesticide Use and
Usage	  PAGEREF _Toc254613134 \h  10

  HYPERLINK \l "_Toc254613135"  3.3.  Environmental Fate and Transport
PAGEREF _Toc254613135 \h  11

  HYPERLINK \l "_Toc254613136"  3.3.1.  Mobility	  PAGEREF _Toc254613136
\h  14

  HYPERLINK \l "_Toc254613137"  3.3.2.  Degradation	  PAGEREF
_Toc254613137 \h  14

  HYPERLINK \l "_Toc254613138"  3.3.3.  Field Dissipation	  PAGEREF
_Toc254613138 \h  15

  HYPERLINK \l "_Toc254613139"  3.3.4.  Bioaccumulation	  PAGEREF
_Toc254613139 \h  15

  HYPERLINK \l "_Toc254613140"  3.4.  Water Quality	  PAGEREF
_Toc254613140 \h  16

  HYPERLINK \l "_Toc254613141"  4.  Receptors	  PAGEREF _Toc254613141 \h
 16

  HYPERLINK \l "_Toc254613142"  4.1.  Effects to Aquatic Organisms
PAGEREF _Toc254613142 \h  17

  HYPERLINK \l "_Toc254613143"  4.2.  Effects to Terrestrial Organisms
PAGEREF _Toc254613143 \h  18

  HYPERLINK \l "_Toc254613144"  4.3.  Incident Databases Review
PAGEREF _Toc254613144 \h  20

  HYPERLINK \l "_Toc254613145"  4.4.  Ecosystems Potentially at Risk
PAGEREF _Toc254613145 \h  21

  HYPERLINK \l "_Toc254613146"  5.  Assessment Endpoints	  PAGEREF
_Toc254613146 \h  21

  HYPERLINK \l "_Toc254613147"  6.  Conceptual Model	  PAGEREF
_Toc254613147 \h  22

  HYPERLINK \l "_Toc254613148"  6.1.  Risk Hypothesis	  PAGEREF
_Toc254613148 \h  22

  HYPERLINK \l "_Toc254613149"  6.2.  Conceptual Diagram	  PAGEREF
_Toc254613149 \h  22

  HYPERLINK \l "_Toc254613150"  7.  Analysis Plan	  PAGEREF
_Toc254613150 \h  24

  HYPERLINK \l "_Toc254613151"  7.1.  Stressors of Concern	  PAGEREF
_Toc254613151 \h  25

  HYPERLINK \l "_Toc254613152"  7.2.  Measures of Exposure	  PAGEREF
_Toc254613152 \h  26

  HYPERLINK \l "_Toc254613153"  7.3.  Measures of Effect	  PAGEREF
_Toc254613153 \h  27

  HYPERLINK \l "_Toc254613154"  7.4.  Integration of Exposure and
Effects	  PAGEREF _Toc254613154 \h  28

  HYPERLINK \l "_Toc254613155"  7.5.   Uncertainties	  PAGEREF
_Toc254613155 \h  29

  HYPERLINK \l "_Toc254613156"  7.6	Endangered Species Assessments
PAGEREF _Toc254613156 \h  30

  HYPERLINK \l "_Toc254613157"  7.7.  Drinking Water Assessment
PAGEREF _Toc254613157 \h  30

  HYPERLINK \l "_Toc254613158"  7.8.  Preliminary Identification of Data
Gaps	  PAGEREF _Toc254613158 \h  30

  HYPERLINK \l "_Toc254613159"  7.8.1.  Fate	  PAGEREF _Toc254613159 \h
30

  HYPERLINK \l "_Toc254613160"  7.8.2.  Effects Data for the Allethrins
 PAGEREF _Toc254613160 \h  32

  HYPERLINK \l "_Toc254613161"  8.  References	  PAGEREF _Toc254613161
\h  37

  HYPERLINK \l "_Toc254613162"  APPENDIX A:  Toxicity Data for the
Allethrins:	  PAGEREF _Toc254613162 \h  42

  HYPERLINK \l "_Toc254613163"  APPENDIX C:  Chemical Structures of
Allethrins.	  PAGEREF _Toc254613163 \h  50

  HYPERLINK \l "_Toc254613164"  APPENDIX E:  Aggregate Ecological
Incident Reports for Allethrins.	  PAGEREF _Toc254613164 \h  54

  HYPERLINK \l "_Toc254613165"  APPENDIX F:  Data Call-In Tables.
PAGEREF _Toc254613165 \h  55

 1.  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 allethrin isomers (allethrins), considering their currently
registered uses.  ‘Allethrins’ refer to several particular mixtures
of the stereoisomers of the chrysanthemic acid ester of allethrolone.
Those mixtures include bioallethrin (also referred to as d-trans
allethrin; PC Code: 004003), esbiothrin [PC Code: 004007 (formerly
004003/004004)], esbiol (also referred to as s-bioallethrin; PC Code:
004004), and pynamin forte (PC Code: 004005).  The ‘allethrins’ also
include allethrin (PC Code: 004001) and allethrin coil (004002);
however, all uses of allethrin and allethrin coil have been withdrawn or
cancelled.  Therefore, this problem formulation focuses on bioallethrin,
esbiothrin, esbiol, and pynamin forte.

Allethrins, which are Type I pyrethroids, are nonsystemic insecticides
and acaricides.  Allethrins typically make up less than 1% of end-use
products and are used as knockdown agents (defined here as agents that
cause rapid paralysis that may be reversible and that may or may not
lead to death) instead of ‘killing agents’ in most of the products
that contain them.  Common product forms include wasp and hornet
aerosols; yard and patio foggers; flying insect killer aerosols; total
release aerosols (indoor foggers); mosquito repellants (mats and coils);
space sprays; and crawling insect killer aerosols.  The allethrins are
registered for both indoor and outdoor uses.  Outdoor products are used
in a geographically limited area and are limited to foggers and spot
treatments that are typically packaged as small, hand-held units and
mosquito repellents (mats and coils).  Based on information provided by
the technical registrants, allethrins outdoor use generally totals less
than 10,000 pounds active ingredient per year.  Because of the
relatively limited use of the compound as an aerosol/fogger spot
treatment in residential settings, there is a low likelihood of the
compound contaminating human drinking water sources, a drinking water
assessment will not be conducted to support a human dietary risk
assessment for the allethrins.  This document will provide a plan for
analyzing data relevant to the allethrins and for conducting
environmental fate, ecological risk, and endangered species assessments
for their 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 the allethrins.

2.  Problem Formulation

2.1.  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 Environmental Protection Agency (EPA).  In
determining whether a pesticide can be registered in the U.S., the
Agency 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, and the Agency 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 the allethrins to determine whether they continue to meet
the FIFRA standard for registration.  This problem formulation for the
environmental fate, ecological risk, and endangered species assessment
chapter in support of the registration review will be posted in the
initial docket which will open the public phase of the review process.

2.2.  Previous Assessments

2.2.1.  Ecological Risk Assessments

Allethrin, the first synthetic pyrethroid, was initially synthesized and
first registered in 1949.  Because the allethrin compounds are nearly
identical except in the ratios and amounts of the major isomers, which
are assumed to be equipotent, the ecological and environmental fate data
for the allethrins have been bridged (i.e., allowing data on one
compound to represent another compound) in previous Agency risk
assessments.  Allowing environmental fate and ecological effects data to
be bridged is consistent with the Agency’s Health Effects Division
(HED) Toxicology Branch decision regarding data call-ins in 1984 and
1985 to allow Roussel Uclaf (a manufacturer of allethrin products at
that time) to use esbiothrin as a representative to satisfy the testing
requirements for esbiothrin, bioallethrin, and esbiol [see USEPA, 1986
(TXR No.: 0052388)].  In 1988, the Agency published a Registration
Standard for the allethrins (USEPA, 1988).  Pynamin forte was excluded
from the Bioallethrin Registration Standard because it was being tested
by another registrant (Sumitomo).  Allethrin was not included in the
Registration Standard because it was going to be cancelled by the
registrant (USEPA, 1986).  Pynamin forte, but not allethrin (because it
has been cancelled), will be included in this assessment.

A national-level ecological risk assessment was completed to support the
reregistration eligibility decision (RED) for the allethrins in 2007
(USEPA, 2007).  The RED was revised in 2009 to update the Agency’s
occupational and residential risk assessment to account for the
commercial animal premise automated misting system use that was not
addressed in the earlier RED (USEPA 2009).  No changes were made to the
ecological risk assessment in the revised RED.  For the RED, as with
previous assessments, the ecological and environmental fate data for the
different allethrin isomers were bridged (i.e., used interchangeably).

The RED indicated that, although there are uncertainties regarding the
extent of use in residential settings, the cumulative exposure from the
supported outdoor uses (i.e., spot treatments) was not likely to be
substantial.  The potential for risk to non-listed terrestrial organisms
is limited or eliminated by the application methods described on the
product labels.  For example, calculations indicated that it would
require the amount of active ingredient in a large number of cans of
wasp and hornet spray, applied at the same time over an acre, to reach
the acute endangered species LOC for birds (293 cans/acre), mammals (211
cans), and terrestrial invertebrates (95 cans/acre).  Additionally, if
the product were sprayed directly into a standard farm pond, it would
require 47.5 and 176.5 cans discharged simultaneously to reach an
exposure concentration equal to the toxic endpoints of concern for
freshwater invertebrates and freshwater fish, respectively.
Additionally, a typical spot treatment containing allethrins, such as
Rainbow Wasp and Ant Spray (EPA Reg. No.: 13283-13), is intended as a
spot treatment on wasp or other stinging insect hives.  The registrant
described the typical use as a 3-second spray directed application at a
hive, which would result in an application of about 0.156 g to an area
of about 1000 cm2.  This rate is equivalent to an application of about
13.8 lb ai/acre.  If this application rate is used as input to the T-REX
model, the acute and acute endangered species RQs for birds and mammals
would exceed levels-of-concern.  However, to reach that level of
exposure, birds or mammals would essentially need to consume the treated
hive to ingest the allethrins applied by a directed spray.

The fogger application for the allethrins also represents an exposure
scenario that is unlikely to result in risk to non-listed birds and
mammals.  The risk assessment considered exposure from a typical fogger
containing allethrins: Raid Yard Guard Outdoor Fogger Formula VII (EPA
Reg. No.: 4822-394), a total release fogger which could affect flying
insects in a 15-by-15 foot area, releasing 1.07 g of allethrins along
with another insecticide.  If all the mass of allethrins were deposited
in that 225 square-foot area, the application would be equivalent to
about 0.47 lb ai/acre, and the resulting RQs would exceed the endangered
species (but not the non-listed species) levels of concern for birds and
mammals.

Therefore, based on the analysis in the assessment done for the RED, the
supported outdoor allethrin uses were expected to result in exposure
levels below Agency acute LOCs for non-listed, non-target organisms in
both aquatic and terrestrial environments.  Therefore, the likelihood of
adverse effects from acute exposure was concluded to be low.  The
likelihood of adverse effects from chronic exposure to mammals was also
considered low; however, the potential risk to all other taxa from
chronic exposure to allethrins could not be assessed due to a lack of
data.  Additionally, the RED concluded that potential risk to aquatic
organisms from acute exposure in surface water resulting from indoor
uses (e.g., pet shampoos being washed down the drain) could not be
dismissed.  This use (i.e., use on pets) was cancelled as of April 2009.

Regarding listed species, specific levels of concern could not be
evaluated for the supported uses of allethrin because actual RQs were
not calculated in the assessment conducted for the RED, however, acute
risks from allethrin outdoor uses to listed species (with the possible
exception of the fogger use) were not expected due to low application
rates and the types of uses being assessed.  However, the potential for
chronic risk to any listed animal could not be dismissed because of a
lack of available data.

Ecological risk mitigations identified in the allethrins RED included:

Cancellation of the following allethrins uses:

Pet shampoos and dips

Boat/ship hulls

Kennels/stables and commercial premises (outdoor and area sprays –
limited to localized treatments)

Drainage systems

Golf course turf

Wide area/general outdoor treatment

Airports/landing fields

Uncultivated agricultural areas

Paved areas

Outdoor ornamental use sites limited to spot use

Outdoor mosquito adulticide use limited to a localized spray

These mitigations have been implemented on all of the current allethrin
technical labels (approved and stamped in April 2009).  The technical
labels stipulate that no end-use product can be manufactured from the
technical for a use that is not specified on the technical labels.

2.2.2.  Drinking Water Exposure Assessments

The Agency has not previously conducted a drinking water assessment for
the allethrins because the chemical's use was considered limited to
indoor non-food uses, and was labelled for only limited outdoor uses
(e.g., spot treatments, foggers).  Because of the relatively limited use
of the compound as an aerosol/fogger spot treatment in residential
settings, there is a low likelihood of the compound contaminating human
drinking water sources, so a drinking water assessment will not be
conducted to support a human dietary risk assessment for the allethrins.

3.  Stressor Source and Distribution

The allethrin compounds are composed of mixtures of eight stereoisomers
(see Table 3.1).  The Bioallethrin Registration Standard covered two
active ingredients (d-trans chrysanthemic acid ester of d-allethrolone
and d-trans chrysanthemic acid ester of l-allethrolone) which are
present in the compounds assessed here (bioallethrin, esbiothrin,
esbiol, and pynamin forte) (USEPA, 1987).  Additionally, there are up to
six other stereoisomers present in each compound that are considered
manufacturing impurities from the production of the active ingredients
[see USEPA, 1997 (D222638)].  In the absence of conclusive evidence
suggesting otherwise (see APPENDIX A), it is assumed all of the
allethrin stereoisomers have similar toxicities.

Following the approach used in the Bioallethrin Registration Standard
and the allethrins RED (USEPA, 2007), it is assumed that the allethrin
mixtures are nearly identical except in the ratios and amounts of the
major isomers, which are assumed to be equipotent.  Therefore, the
ecological and environmental fate data for the allethrins are bridged
(i.e., used interchangeably) for this assessment.  Although the current
assessment focuses on esbiol, esbiothrin, bioallethrin, and pynamin
forte, data from all of the allethrin mixtures (including allethrin) are
bridged and utilized.  Additionally, to more fully characterize the
environmental fate and transport of the allethrins in spite of numerous
data gaps, data for the structurally similar but naturally occurring
compound, pyrethrin 1, will be utilized in the assessment in addition to
the submitted data for the allethrins.  This data bridging will be
conducted because of the high structural similarity between the
allethrins, which are synthetic pyrethroids, and the naturally occurring
pyrethrins.

TABLE 3.1: Composition of the Allethrins1.

ISOMER	Allethrin [PC Code(s)]

	Esbiol [004004]	Esbiothrin

[004007] [formerly 004003/004004]	Bioallethrin [004003]	Pynamin Forte
[004005]	Allethrin [004001]

d-trans chrysanthemic acid of d-allethrolone2	>90%	72%	≥46.5%	36.5%
18%

d-trans chrysanthemic acid of l-allethrolone	5%	21%	≥46.5%	36.5%	18%

d-cis chrysanthemic acid of d-allethrolone	-3	-	-	9%	4.5%

d-cis chrysanthemic acid of l-allethrolone	-	-	-	9%	4.5%

l-trans chrysanthemic acid of d-allethrolone	-	-	-	-	18%

l-trans chrysanthemic acid of l-allethrolone	-	-	-	-	18%

l-cis chrysanthemic acid of d-allethrolone	-	-	-	-	4.5%

l-cis chrysanthemic acid of l-allethrolone	-	-	-	-	4.5%

1 Adapted from USEPA 1997 (D222638)

2 Most insecticidally active isomer

3 Indicates <2%

The allethrin mixtures, which include bioallethrin, esbiothrin, esbiol,
and pynamin forte, are the active ingredients in the allethrin end-use
products that are considered in this problem formulation (for a summary
of the products see APPENDIX B).  They are typically combined with
residual pyrethroids (e.g., permethrin, tralomethrin, resmethrin,
deltamethrin, sumithrin, esfenvalerate) or insecticide synergists (e.g.,
piperonyl butoxide, MGK-264) which can increase the toxicity of the
allethrins.  Where data indicate that specific formulated products are
more toxic than the technical grade active ingredient, the potential
risks associated with these specific products will be characterized and
will be used to represent the overall risks associated with allethrin.

3.1.  Mechanism of Action

The allethrins are broad spectrum, nonsystemic insecticides and
acaricides used to control a variety of crawling and flying insects,
mites and spiders.  The allethrins are synthetic compounds (pyrethroids)
that duplicate the activity of naturally occurring plant pyrethrins.
Allethrin, first synthesized in 1949, was the first pyrethroid
developed.  The allethrins are Type I pyrethroids that resemble the
insecticide DDT, (dichlorodiphenyltrichloroethane) in their mode of
action.  They are axonic poisons that block the closing of the sodium
gates in the nerve cell axon’s (axonal) membrane, and, thus, prolong
the return of the membrane potential to its resting state.  This leads
to hyperactivity of the nervous system, which can then result in
paralysis and/or death.

3.2.  Overview of Pesticide Use and Usage

  SEQ CHAPTER \h \r 1 The main use for the allethrins is as a knockdown
agent (defined here as an agent that causes rapid paralysis that may be
reversible and that may or may not lead to death) against a variety of
flying and crawling insects, mites and spiders; however, they can also
function as insecticides when used at higher rates.  Formulations that
contain an allethrin are typically mixed with other killing agents
(e.g., permethrin, tralomethrin, resmethrin, deltamethrin, sumithrin,
esfenvalerate) and/or synergists (e.g., piperonyl butoxide, MGK-264)
with allethrin typically comprising < 1% of the formulation.  Outdoor
uses of the allethrins are limited to localized space and contact
sprays, perimeter treatments, and ornamental spot applications against
crawling and flying insects.  Typical formulations for the above uses
include pressurized liquids, ready-to-use liquid sprays, mosquito coils
and mats, emulsifiable concentrates, and liquid concentrates.
Application methods include aerosol cans, foggers, mosquito coils,
trigger sprayers, and bait stations.

Allethrins are different from all other pyrethroids previously assessed
by the Agency’s Office of Pesticide Programs (OPP) because their
outdoor uses are limited strictly to small-scale residential uses (i.e.,
there are no large-scale allethrin uses such as agricultural or public
health/mosquito abatement uses).  Furthermore, allethrin, as an
early-generation pyrethroid, differs structurally from more-recently
developed pyrethroids which have structural modifications, such as
alterations to the isobutenyl group attached to the cyclopropane moiety.
This structural difference makes them more persistent than the early
generation pyrethroids.  Therefore, allethrin is among the least
persistent of all pyrethroids (less persistent than permethrin,
cypermethrin, cyfluthrin, cyhalothrin, deltamethrin, fenvalerate,
tefluthrin, and tralomethrin (ATSDR, 2003)).  Standard use rates
typically reported for agricultural chemicals (i.e., lb/acre) are not
applicable for allethrin end use products, due to the types of uses for
which they are registered; in most cases, maximum application rates
cannot be calculated from label language.

Although maximum use rates cannot be calculated from current labels,
some information is available on application rates for the most common
outdoor uses (see Table 3.2).

TABLE 3.2.  Application Rates for the Main Outdoor Allethrin Uses
(Based on Current Labels and Information Provided at the 11/30/2005
SMART Meeting with OPP).

Use/Application Method1	Application2	Target Area	Metric Rate	Converted
Rate3, 4

Wasp and hornet nest/aerosol spray	3 sec spray, 20 g product/sec
discharge rate, 0.26% w/w bioallethrin (Reg. No.: 13283-13)	Wasp/hornet
nest

(1000 cm2)	156 mg a.i./m2

	0.00032 lb a.i./ft2

(13.76 lb a.i./A)

Yard and patio/fogger	3 sec spray, 6 g product/sec discharge rate, 0.15%
w/w bioallethrin	4 x 4 m2	1.7 mg a.i./m2

	0.00000034 lb a.i./ft2

(0.0148 lb a.i./A)

Mosquito repellant/mat 	1.6 g pad impregnated with 22% pynamin forte,
350 mg a.i. evolves over 4 hr (1.46 mg a.i./min)	4 x 4 m2	0.091 mg
a.i./m2/min

(0.0000002 lb/

	0.00000002 lb a.i./ft2/

min

1 The uses and application methods were chosen because they represent
the most common outdoor uses of the allethrin products based on
information provided by the registrant in the SMART meeting
(11/30/2005).  Coils also represent one of the most common uses;
however, mats have higher application rates than coils, therefore, only
the estimated mat typical application rates were provided by the
registrant.

2 The application information represents ‘typical’, and not
necessarily maximum, use rates based on information provided by the
registrant.  However, in cases when end-use products for specific uses
contain a range of allethrin percentages (e.g., yard and patio foggers
typically contain 0.1 – 0.15 % bioallethrin) as provided by the
registrants, the higher end of the range was used in the calculations,
unless a higher % a.i. was found in a search of OPP’s Pesticide
Product Label System (PPLS).  In the cases where a higher % a.i. was
found on a label for a similar product, it is identified by the EPA
registration number.

3 The rates are based on the assumption that all of the material applied
will fall on the target area, however, in reality some of the material
is expected to remain airborne and to be dispersed by wind away from the
target area.

4 The ‘a.i.’ in the calculations refers to the amount of the
specific allethrin used in each product (i.e., for ‘wasp and hornet
nest’ and ‘yard and patio’ uses it refers to the amount of
bioallethrin, and for the ‘mats’ it refers to pynamin forte);
therefore, the application rate specifically for d-trans chrysanthemic
will be lower than the application rates presented.

3.3.  Environmental Fate and Transport

While the environmental fate database for the allethrins is sparse,
there are sufficient data available to assess the environmental fate of
the compound for the labeled uses, and there are no outstanding data
gaps for the current uses.  The physical/chemical and the environmental
fate properties for the allethrins are presented in Table 3.3.  The
majority of the data reported are for the isomer, d-trans chrysanthemic
acid of d-allethrolone (d-trans allethrin).  Based on these data, the
allethrins are low to moderately volatile compounds that are slightly
persistent in aerobic soil and are expected to have low mobility in most
soils.  The main transformation products of the allethrins are CO2
(maximum of 71% in an aerobic soil metabolism study), allethrolone
(maximum of 18.9% in the hydrolysis study), and dihydroxyallethrolone
(maximum of 34.9% in the photolysis study).  There were also unextracted
residues (maximum of >40% in an aerobic soil metabolism study) detected
in the studies; these constitute an uncertainty as it is unclear whether
they include parent compound.  Two major degradates in the hydrolysis
study (pH 9 only) were not identified, but were present at maximums of
approximately 35% and 29%. Mobility is expected increase in soils with
low organic matter content.  Structures of the parent compound
stereoisomers are presented in APPENDIX C.

In order  to more fully characterize the environmental fate and
transport of the synthetic allethrins, EFED has considered some of the
data for the structurally similar but naturally occurring compound
pyrethrin 1 in addition to the data submitted for the allethrins.  This
data bridging was conducted because of the high structural similarity
between the allethrins, which are synthetic pyrethroids, and the
naturally occurring pyrethrins.

Because the submitted studies were conducted using the active
ingredient, EFED cannot make a determination of how or if the synergist
PBO, present in formulated products, may affect the environmental fate
properties of the parent compound.

TABLE 3.3.  General Chemical and Environmental Fate Parameters of
Allethrins.

Property	Value	Source and/or Comments

Chemical Name	[(4'RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl
(1R)-trans-chrysanthemate;

CAS name:
[1R-[α(S*),3ρ]]-2,2-dimethyl-3-2(2-methyl-1-propenyl)cyclopropanecarbo
xylic acid 2-methyl-4-oxo-3-(2-propenyl)-2-cylcopenten-1-yl ester
d-trans allethrin is the most insecticidally active isomer and is
present at 72% in esbiothrin, >46.5% in bioallethrin, >90% in esbiol,
and 36% in pynamin forte

Molecular Weight	302.4	Product Chemistry Data Reviews

Solubility in Water (20C)	4.6 mg/L

                    5.0 mg/L	Bioallethrin, Esbiothrin, Esbiol Product
Chemistry Data Reviews (d-trans allethrin); 42193303(Esbiol)

41115302; Pynamin Forte Product Chemistry Data Review

Vapor Pressure (25C)	3.3 X 10-4 torr

1.24 X 10-6 torr	Bioallethrin, Esbiothrin, Esbiol Product Chemistry Data
Reviews (d-trans allethrin); 42193303(Esbiol)

41115307; Pynamin Forte Product Chemistry Data Review

Hydrolysis Half-life (pH 5, 7, 9; 25C)	no significant degrad. at pH 5,
7;

half-life of 4.3 days at pH 9	MRID 41504401; study on d-trans allethrin

Aqueous Photolysis Half-life (pH 5)	photolyzes at unknown rate	MRID
41504402; study on d-trans allethrin; half-life could not be calculated
and study was classified unacceptable

Soil Photolysis Half-life	No data	--

Aerobic Soil Metabolism Half-life (days)	Reported half-lives of
16.9-22.0 days (acid-labeled moiety) and 40.1-42.5 days (alcohol-labeled
moiety)	MRIDs 42336501, 42336502; study on d-trans allethrin

Anaerobic Soil Metabolism Half-life (days)	No data	--

Aerobic Aquatic Metabolism Half-life (days) 	No data	--

Anaerobic Aquatic Metabolism Half-life (days)	No data	--

Organic Carbon-Normalized Soil Partition Coefficient (Koc)	1409, 1358,
1134, 1718	MRID 41900401; study on d-trans allethrin; compound is
slightly mobile in soil based on the FAO Soil Mobility Classification
Scheme

Soil Adsorption Coefficient (Kd; mL/g)	4.1, 6.2, 15.8, 25.9 	MRID
41900401; study on d-trans allethrin

Log Kow (pH 7)	>5

4.95

	Bioallethrin, Esbiothrin Product Chemistry Data Reviews (d-trans
allethrin)

41115302; Pynamin Forte Product Chemistry Data Review

Henry’s Law Constant	No data	--

Bioconcentration Factor in Fish (BCF)	No data	High log Kow values
indicate the potential for bioaccumulation.

3.3.1.  Mobility

The allethrins are expected to have low mobility in most soils.
However, because adsorption of the compound is correlated with organic
carbon content, they are likely to be somewhat more mobile in soils with
lower organic matter content, such as coarse sand soils.  In an
acceptable batch equilibrium study, Koc values ranged from 1134 to 1718
(mean of 1405 from four soils; MRID 41900401).  Based on the FAO Soil
Mobility Classification Scheme, these Koc values indicate that d-trans
allethrin can be expected to be slightly mobile in soil, with greater
mobility in soils with lower organic matter content.

3.3.2.  Degradation

The submitted hydrolysis study is classified as “supplemental” and
the submitted aqueous photolysis study is classified “not
acceptable.”  However, it is known that the synthetic pyrethroids as a
class tend to photodegrade fairly quickly under ideal conditions.
Furthermore, as an early-generation pyrethroid, allethrin is expected to
be one of the least persistent pyrethroids.  The two submitted aerobic
soil metabolism studies, which are considered scientifically valid
individually, are both classified “supplemental” due to
discrepancies between the results of the two studies.  Results do
indicate that aerobic metabolism will be a significant degradation
process for these compounds.

The allethrins are stable to hydrolysis at pH 5 and 7, but undergo
fairly rapid hydrolysis (half-life of 4.3 days) at pH 9, with
degradation to major degradates including two unidentified compounds.
This is more rapid than, but somewhat similar to, the hydrolysis rates
observed for pyrethrin 1.  In submitted studies for that compound,
pyrethrin 1 was stable to hydrolysis at pH 5 and 7, and hydrolyzed at pH
9 with a DT50 of 14 days (MRID 43188201) and a calculated half-life of
17 days (MRID 43567502).  In the allethrins study at pH 9, the major
degradates were allethrolone (maximum of 18.9% at 171 hours; still
present at 18.8% at 390 hours or study termination); the unidentified
compound “1A” (maximum of  34.9% at 390 hours); and the unidentified
compound “2A” (maximum of  28.7% at 171 hours; still present at
24.0% at 389.5 hours or study termination).

Based on available information, aqueous photolysis is a potential
degradation pathway for the allethrins, as for synthetic pyrethroids, if
the compounds reach surface water and are present in an unsorbed state
in clear and shallow surface water.  Under such conditions, the
allethrins are expected to photodegrade fairly quickly in water based on
the known photolability of synthetic pyrethroids (HSDB, 2006).  However,
the submitted aqueous photolysis study (MRID 41504402) was classified
“not acceptable”, and an accurate photodegradation half-life cannot
be calculated from the data provided.  These data were also insufficient
to show the patterns of formation and decline for the degradates.  The
conclusion of rapid photodegradation is passably consistent with the
rapid degradation observed for pyrethrin 1, which underwent
photo-initiated isomerization (to the (E)-isomer) with an observed
half-life of approximately 1 hour in sterile aqueous 0.01 M buffer
solutions (pH 7) (MRIDs 43096601, 43567601).  In that study, the overall
calculated half-life of dissipation of pyrethrin 1 and its (E)-isomer
was 12 hours.

However, direct photolytic degradation of pesticides in turbid and/or
deeper waters in the environment may be limited by the attenuation of
sunlight, and the half-life may be greatly extended under such
conditions (e.g., it is 124X longer in PRZM/EXAMS simulations since
conditions are not ideal as in laboratory studies).  Thus, caution must
be used in extrapolating laboratory photolysis data (obtained under
optimal conditions) to the environment.  Also, adsorption of the
allethrins to suspended particles in the water column will decrease the
amount available for photolytic degradation.  Additionally, the
co-presence of the pesticide trifluralin has been observed to
photostabilize the allethrins (Dureja et al., 1984).  In the allethrins
study, the major degradates were allethrolone (maximum of  9.8% at 72
and 120 hours, study termination) and dihydroxyallethrolone (maximum of
34.9% at 120 hours).

It is not known whether the allethrins will photodegrade on surface
soil; data have not been submitted.  In aerobic soil, the allethrins
biodegraded with half-lives of 16.9-22.0 days (acid-labeled moiety; MRID
42336501) and 40.1-42.5 days (alcohol-labeled moiety; MRID 42336502).
Although the two studies have discrepancies between the reported
half-lives, the data indicate that aerobic metabolism will be a
significant degradation process in soils for these compounds.  Based on
a published classification scheme of persistence in soil (Goring et al.,
1975), the allethrins are expected to be slightly persistent in aerobic
soil.  In the acid-labeled moiety study, 39% of the applied d-trans
allethrin had mineralized to CO2 by 6 months, and unextractable,
unidentified residues accounted for greater than 40% of the applied by
that time.  In the alcohol-labeled moiety study, CO2 was 71% of the
applied by 6 months and unextractable, unidentified residues accounted
for a maximum of 19% of the applied by 4 months.  The conclusion that
aerobic metabolism will occur readily and will be a significant
degradation pathway for the allethrins is passably consistent with the
expected rapid degradation of pyrethrin 1, which was metabolized in
aerobic soil with a half-life of 10 days, yielding similar levels of CO2
and unextractable residues as those seen in the acid-labeled d-trans
allethrin study.  It is also consistent with the increased persistence
expected of the allethrins relative to pyrethrin 1 due to the presence
of a more stable side chain in the former (Worthing, 1979).

Information on metabolism in anaerobic soil or in either aerobic aquatic
or anaerobic aquatic environments is not available, as data have not
been submitted.  Based on the current label uses, these studies are not
considered data gaps at this time.

3.3.3.  Field Dissipation

The persistence of the allethrins in the field is also unknown, as data
on the field dissipation of the compounds have not been submitted.

		3.3.4.  Bioaccumulation

The potential for bioaccumulation of the allethrins in fish is not
known; data have not been submitted.  High log Kow values of >5 and
4.95, reported in submitted studies, indicate that there may be a
potential for bioaccumulation. Additionally, data submitted for
pyrethrin 1 indicate that there may be a high potential for
bioaccumulation.  Pyrethrin 1 residues accumulated in bluegill sunfish
continuously exposed to the compound for 28 days under laboratory
flow-through conditions.  Mean bioconcentration factors were 127x for
the edible tissue, 873x for the non-edible tissue, and 471x for the
whole fish (pyrethrin 1 MRIDs 43302301, 43884102).  In that study, 77%
of the accumulated [14C] residues were eliminated from the edible
tissues, 66% from the non-edible tissues, and 68% from the whole fish by
day 1.  By day 14, residues in edible tissues were below the detection
limit (1 ppb) and were close to the detection limit (average = 1.29 ppb)
in viscera.  Based on the current labeled uses and the limited potential
for exposure to the allethrins, bioaccumulation is not expected to be a
concern in the environment.

3.4.  Water Quality

While there is some potential for the allethrins to reach surface water
through spray drift when applied as an outdoor spray or fogger, it is
likely to be minimal based on the supported uses.  Similarly, because
the allethrins may be slightly persistent in the environment, there is
some potential for them to be present in field runoff and eventually
reach surface water bodies.  However, the potential is minimal since
current uses are mainly spot treatments, which should result in very low
total application rates for a given time and place of use.  For
groundwater, the potential for contamination is also considered minimal,
based on supported uses, the rate of aerobic soil degradation, and the
tendency for the compounds to adsorb to surface soils.  There is a
slightly higher (yet likely still minimal) potential for groundwater
contamination when the allethrins are used on low organic matter soils
or on neutral or acidic sandy soils over shallow aquifers.

4.  Receptors

Consistent with the process described in the Overview Document (USEPA
2004), the risk assessment for the allethrins 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 the potential effects on
a variety of species (receptors) included under these taxonomic
groupings.  In the absence of conclusive evidence suggesting otherwise
(see APPENDIX A), it is assumed all of the allethrin stereoisomers have
similar toxicities.  Therefore, the ecological and environmental fate
data for the allethrins are bridged (i.e., used interchangeably) for
this assessment.  The most sensitive endpoints from the available
toxicity data, considering all of the allethrins, will be used to assess
risk.

Acute and chronic toxicity data from studies submitted by pesticide
registrants along with the available open literature are used to help
evaluate the potential direct and indirect effects of allethrins 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,
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 the allethrins on biotic communities from loss of
species that are sensitive to the chemicals and from changes in
structure and functional characteristics of the affected communities.  A
preliminary review of open literature data from ECOTOX (from a search
done in August 2009) on the allethrins was conducted as part of this
Problem Formulation to help identify data gaps.  A more complete review
of the data from ECOTOX will be conducted for evaluation for possible
quantitative and/or qualitative inclusion in this risk assessment.

A summary of the most sensitive data representing non-target organisms
exposed to allethrins in aquatic and terrestrial habitats is provided in
Sections 4.1 and 4.2, respectively.  A summary of ecological incidents
associated with the allethrins and a description of ecosystems
potentially at risk are provided in Sections 4.3 and 4.4, respectively.
Additional information on toxicity data for the allethrins can be found
in APPENDIX A.

4.1.  Effects to Aquatic Organisms

  SEQ CHAPTER \h \r 1 The allethrins are considered very highly toxic to
freshwater fish (LC50 = 7.9 ppb; esbiol; MRID 40098001) and freshwater
invertebrates (LC50 = 2.1 ppb; allethrin; MRID 40098001) on an acute
exposure basis (Table 4.1).  No chronic exposure data for freshwater
animals (vertebrate or invertebrate) are available for the allethrins
and no acute or chronic exposure data are available for any
estuarine/marine fish or invertebrate.  Toxicity data are also lacking
for vascular and non-vascular aquatic plants.    SEQ CHAPTER \h \r 1

TABLE 4.1.    SEQ CHAPTER \h \r 1 Summary of Submitted Toxicity Studies
for Aquatic Organisms Exposed to Allethrins.

SPECIES	CHEM./

(PC CODE)	END-POINT	DUR-ATION (hrs)	CONC. MEAN (ppb)	EXPO-SURE TYPE1
CATEGORY	MRID #

  SEQ CHAPTER \h \r 1 Freshwater Fish

Perca flavescens

Yellow Perch	Esbiol/ 004004	LC50	96	7.9

(6.5 – 9.4)	S	Supplemental	400980012

Oncorhynchus kisutch

Coho Salmon	Bioallethrin/

004003	LC50	96	9.4

(7.91 –11.2)	F	Supplemental	122546

Oncorhynchus mykiss

 Rainbow Trout	Bioallethrin/

004003	LC50	96	9.7

(8.0 – 11.6)	F	Supplemental	40098001

Ictalurus punctatus

Channel Catfish	Esbiol/

004004	LC50	96	14.6

(10.1 –21.0)	F	Supplemental	40098001

Salvelinus namaycush

Lake Trout	Bioallethrin/

004003	LC50	96	17.3

(14.9 –20.0)	S	Supplemental	40098001

  SEQ CHAPTER \h \r 1 Lepomis macrochirus

Bluegill Sunfish	Bioallethrin/

004003	LC50	96	22.5

(20.5 –24.7)	F	Supplemental	40098001

  SEQ CHAPTER \h \r 1 Pimephales promelas

Fathead Minnow	Bioallethrin/

004003	LC50	96	48.0

(34.9 –66.0)	F	Supplemental	40098001

Freshwater Invertebrates

Pteronarcys californica

Stonefly	Allethrin/

004001	LC50	96	2.1

(1.5 – 2.9)	S	Supplemental	400980012

Gammarus fasciatus

Scud	Allethrin/

004001	LC50	96	8

(5.0 – 12.0)	S	Supplemental	40098001

Daphnia pulex

Water Flea	Esbiothrin/

004007	EC50	48	8.9

(7.5 – 11)	S	Acceptable	43235801

Simocephalus serrulatus

Water Flea	Allethrin/

004001	EC50	48	56

(40.0 -78.0)	S	Supplemental	40098001

1 Exposure type refers to the conditions under which the study was
conducted; ‘S’ refers to static conditions, and ‘F’ refers to
flow-through conditions.

2 Following EFED guidance, the raw data from this study were reviewed
and the data were found to be supplemental.

Bolded endpoints represent the most sensitive endpoint for each taxon.

4.2.  Effects to Terrestrial Organisms

  SEQ CHAPTER \h \r 1 The allethrins are considered practically
non-toxic to birds on an acute oral exposure basis [LD50 = 2030 mg/kg-bw
(bobwhite quail); bioallethrin; MRID: 123339] and on a subacute dietary
exposure basis [LC50 >5,620 mg/kg-diet (mallard duck); pynamin forte;
MRID: 27548] (Table 4.2).  No chronic toxicity data on birds are
available for the allethrins.

  SEQ CHAPTER \h \r 1 The allethrins are considered moderately toxic to
mammals on an acute oral exposure basis [LD50 = 378 mg/kg-bw (laboratory
rat); esbiothrin; MRID: 00151449] (Table 4.2).  To explore the potential
increased toxicity of allethrins after acute exposure when mixed with
the synergist piperonyl butoxide, the available acute rat oral toxicity
formulated product data in the OPP Integrative Hazard Assessment
Database (IHAD) were reviewed.  IHAD contains data submitted to OPP by
the registrants on the toxicity of formulated products to mammals.
Based on review of the available data, no increase in toxicity to
mammals from allethrins mixed with piperonyl butoxide, compared to
allethrin alone, could be determined (i.e., most LD50’s were higher
than the highest concentration tested) (see APPENDIX D).

In a 2-generation reproduction study (MRID 41246801) pynamin forte (PC
Code: 004005) was administered to laboratory rats at various dietary
concentrations.  There was no effect upon reproductive indices.  The
parental NOAEL = 200 ppm (13 mg/kg-bw in males and 15 mg/kg-bw in
females) and the parental LOAEL = 2000 ppm (130 mg/kg-bw in males and
145 mg/kg-bw in females) based on reductions in body weights, body
weight gains, increases in absolute and relative liver weights, and
hepatocellular hypertrophy.  The offspring NOAEL is 200 ppm (15
mg/kg-bw) and the LOAEL for offspring toxicity is 2,000 ppm (145
mg/kg-bw) based on reductions in pup body weights of the F2 generation.

The allethrins are considered moderately toxic to adult honey bees (Apis
mellifera) on an acute contact exposure basis [LD50 = 3.4 µg/bee;
allethrin; MRID: 162751] (Table 4.2).  Based on oral exposure,   SEQ
CHAPTER \h \r 1 a study of honey bees indicated toxic effects (LD50)
when adults were fed concentrations of 9.1 µg/bee (allethrin; MRID:
162751).  Sub-lethal effects include paralysis (‘knockdown’) at
concentrations as low as 7.7 ppb (EC50 measured 1 hr after exposure) for
adult mosquitoes (Culex spp.), an intended target species, exposed to
esbiothrin for 10 seconds in a wind tunnel (ECOTOX number: 69764).

TABLE 4.2:   SEQ CHAPTER \h \r 1 Summary of Submitted Toxicity Studies
for Terrestrial Organisms Exposed to Allethrins.

SPECIES	CHEM./

(PC CODE)	END-POINT	DUR-ATION (Days)	CONC. MEAN 	EXPO-SURE TYPE	CATEGORY
MRID #

Birds

Colinus virginianus

Bobwhite Quail	Bioallethrin/

004003	LD50	14	2030

mg/kg-bw

(1504 – 2738)	N/A	Acceptable	123339

Anas platyrhynchos

Mallard Duck	Pynamin Forte/

004005	LC50	8	>5,620 mg/kg-diet	N/A	Acceptable	27548

Mammals

Rattus norvegicus Laboratory Rat	Esbiothrin/ 004007	LD50	14	378 mg/kg-bw
N/A	Acceptable	00151449

Rattus norvegicus Laboratory Rat	Pynamin Forte/

004005	NOAEL	2 generation	13 mg/kg-bw	N/A	Acceptable	41246801

Terrestrial Invertebrates

Apis mellifera

Honey Bee	Allethrin/

004001	LD50	1

	3.4 µg/bee	Contact	Supplemental	162751

Terrestrial Plants

  SEQ CHAPTER \h \r 1 No guideline data were submitted to evaluate the
risk of allethrin exposure to non-target terrestrial plants.    SEQ
CHAPTER \h \r 1 Although in previous risk assessments risk to plants
from allethrin use was not expected because of the allethrins’ neural
toxic mode of action and the results of efficacy studies provided by the
registrant, 13 ‘minor’ plant incidents involving terrestrial plants
have since been identified (see Section 4.3).

4.3.  Incident Databases Review

Preliminary reviews of the Ecological Incident Information System (EIIS,
version 2.1), the Aggregate Incident Reports database, and the Avian
Incident Monitoring System (AIMS) for all of the allethrins were
conducted on October 14, 2009.  There are currently no reported
incidents involving allethrins listed in the AIMS databases.    SEQ
CHAPTER \h \r 1 The EIIS database identified a total of one ecological
incident involving an allethrin (allethrin; PC Code: 004001) (Incident
no.: I012970-013).  The allethrin involved in the incident (i.e.,
allethrin, PC Code 004001) is no longer registered (i.e., all of its
uses have been cancelled).  The incident occurred on a fish farm in
Ventura County, CA, in Dec. 2000, and it involved the death of 13,000
rainbow trout.  The reported cause of the incident was an act of
sabotage (i.e., it was the result of intentional misuse).  The certainty
index was reported as “highly probable” and it was reported that,
“(t)here seemed to be no doubt about the cause of the fish kill,”
although no tissue or water samples were reported.

In addition to the incident recorded in EIIS, 13 additional incidents
have been reported to the Agency in aggregated incident reports (all
terrestrial plant incidents involving d-trans allethrin; PC Code:
004003) (see APPENDIX E).  Pesticide registrants report certain types of
incidents to the Agency as aggregate counts of incidents occurring per
product per quarter.  Ecological incidents reported in aggregate reports
include those categorized as ‘minor fish and wildlife’ (W-B),
‘minor plant’ (P-B), and ‘other non-target’ (ONT) incidents.
‘Other non-target’ incidents include reports of adverse effects to
insects and other terrestrial invertebrates.  For the allethrins,
registrants have reported for 13 minor terrestrial plant incidents that
occurred from 1995 until 2005.  In the absence of additional information
on these aggregated incidents they will be assumed to be representative
of registered uses of the allethrins and described in the risk
assessment.  Because the number of documented incidents in the available
incident databases is believed to be a very small fraction of total
ecological incidents (i.e., mortality) caused by pesticides for a
variety of reasons, absence of reports does not necessarily provide
evidence of an absence of incidents given the nature of the incident
reporting.

4.4.  Ecosystems Potentially at Risk

The ecosystems 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.  Although risks to
terrestrial ecosystems are presumed to be low based on the limited
potential for exposure, in general terms, terrestrial ecosystems
potentially at risk could include the treated site and immediately
adjacent areas that may receive drift or runoff.

Although risks to aquatic ecosystems are presumed to be low based on the
limited potential for exposure, aquatic ecosystems potentially at risk
include water bodies adjacent to, or down stream from, the treated site
and could 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.

5.  Assessment Endpoints

Assessment endpoints represent the actual environmental value that is to
be protected, defined by an ecological entity (species, community, or
other entity) and its attribute or characteristics (USEPA 1998).  For
the allethrins, the ecological entities may include the following:
birds, mammals, terrestrial-phase amphibians, reptiles, freshwater fish
and invertebrates, aquatic-phase amphibians, estuarine/marine fish and
invertebrates, terrestrial plants, terrestrial invertebrates, and
aquatic plants.  The attributes for each of these entities include
growth, reproduction, and survival.

6.  Conceptual Model

For a pesticide to pose an ecological risk, it must reach ecological
receptors in biologically significant concentrations.  An exposure
pathway is the means by which a pesticide moves in the environment from
a source to an ecological receptor.  For an ecological pathway to be
complete, it must have a source, a release mechanism, an environmental
transport medium, a point of exposure for ecological receptors, and a
feasible route of exposure.  The conceptual model for the allethrins
provides a written description and visual representation of the
predicted relationships between allethrins, 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 (USEPA 1998).

  SEQ CHAPTER \h \r 1 The conceptual model used to depict the potential
ecological risk associated with the allethrins is fairly generic and
assumes that as broad spectrum, nonsystemic insecticides and acaricides,
the allethrins are capable of affecting terrestrial and aquatic animals
provided environmental concentrations are sufficiently elevated as a
result of proposed label uses.  Additionally, based on a preliminary
risk screening and past assessments indicating that (as a pyrethroid)
the allethrins are highly toxic to aquatic organisms and some
terrestrial taxa (i.e., terrestrial invertebrates), the hypothesis for
the risks of allethrins to non-target organisms (depicted in Figures 6.1
and 6.2) focuses on aquatic and terrestrial environments.  Therefore,
potential exposure as a result of direct applications, spray drift, and
runoff will be considered.

6.1.  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 the allethrins, the following
ecological risk hypothesis is being employed for this ecological risk
assessment:

Based on mode of action and the sensitivity of non-target aquatic and
terrestrial species, the outdoor, residential uses of allethrins [i.e.,
wasp and hornet aerosols; yard and patio foggers; flying insect killer
aerosols; mosquito repellants (mats and coils)] have the potential to
reduce survival, reproduction, and/or growth in terrestrial and aquatic
non-target animals through spray drift and/or runoff.  These non-target
organisms include Federally-listed threatened and endangered species as
well as non-listed species.

	6.2.  Conceptual Diagram

  SEQ CHAPTER \h \r 1 Application methods for the outdoor uses of the
allethrins involve aerosol cans, foggers, mosquito coils and mats,
trigger sprayers, foams, and bait stations.  Ecological receptors that
may potentially be exposed to allethrins include terrestrial and
semi-aquatic wildlife (i.e., mammals, birds, amphibians, terrestrial
invertebrates, and reptiles).  In addition, aquatic receptors (e.g.,
freshwater and estuarine/marine fish and invertebrates, and amphibians)
may also be exposed as a result of potential movement of allethrins via
spray drift and/or runoff from the site of application to aquatic
environments.  The assessment following the process depicted in Figures
6.1 and 6.2 forms the basis for identifying potential endpoints,
stressors, and ecological effects associated with allethrin use.

FIGURE 6.1.  Conceptual Model for Potential Allethrin Effects on Aquatic
Organisms.  Dotted Lines Indicate Exposure Pathways that Have a Low
Likelihood of Contributing to Ecological Risk.

FIGURE 6.2.  Conceptual Model for Potential Allethrin Effects on
Terrestrial Organisms.

7.  Analysis Plan

Most of the standard methods used by the Agency for assessing
environmental risk are established for large-scale uses such as
applications to agricultural fields or public health uses.  Because the
allethrin uses considered here are limited to spot treatments (e.g.,
spraying a wasp hive), area treatments (e.g., burning coils or mats or
using a fogger in a camp site or residential backyard), and ornamental
applications against crawling and flying insects (e.g., spraying hedges
with an aerosol can), a standard risk assessment using RQs compared to
LOCs is not applicable for these kinds of uses.  In this assessment,
standard EECs cannot be directly calculated (without major assumptions)
using the tools that OPP typically relies on.  The difficulty in
calculating standard EECs is due to a multitude of factors including
non-standard use rates (e.g., “20 seconds/1000 cu ft”, “spray 6-8
seconds into nest hole”, “spray as needed”, or “spray until wet)
and estimations of the magnitude of use in a given area (e.g., a
neighborhood or campsite) at a given time.  The approach used in this
risk assessment is to use available tools and information to help
characterize the potential for risk instead of the more typical approach
of comparing RQs to LOCs (see the examples below).

Information regarding exposure includes the following factors: 1) small
amounts are used outdoors at one time, 2) most outdoor uses are limited
to spot treatments, and 3) methods of application (i.e., spray cans,
coils, foggers) are not feasible for treating large spatial areas.
Additionally, based on submitted data, there is a tendency for
allethrins to sorb to surface soils, particularly in soils that are not
low in organic matter.  Furthermore, synthetic pyrethroids as a class
tend to photodegrade fairly quickly, and, as an early-generation
pyrethroid, allethrin is one of the least persistent pyrethroids.

Although there are uncertainties regarding the extent of use in
residential settings, the cumulative exposure from spot treatments is
not likely to be substantial.  This is especially true considering
national usage of allethrins outdoor generally totals less than 10,000
pounds active ingredient per year.

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

	7.1.  Stressors of Concern

The allethrins, which include bioallethrin, esbiothrin, esbiol, and
pynamin forte, are the active ingredients in the allethrin end-use
products that are considered in this problem formulation.  They are
typically combined with other pyrethroids that have residual activity
(e.g., permethrin, tralomethrin, resmethrin, deltamethrin, sumithrin,
esfenvalerate) or with insecticide synergists (e.g., piperonyl butoxide,
MGK-264) which can increase the toxicity of the allethrins.  Where data
indicate that specific formulated products are more toxic than the
technical grade active ingredient, the potential risks associated with
these specific products will be characterized and will be used to
represent the overall risks associated with allethrin.

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
(USEPA 2004; USFWS/NMFS 2004).

Available toxicity data for environmental mixtures of allethrins with
other pesticides will be presented as part of the ecological risk
assessment.  It is expected that the toxic effect of the allethrins, 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 allethrin 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.

	7.2.  Measures of Exposure

  SEQ CHAPTER \h \r 1 Agency measures of exposure are typically based on
terrestrial and aquatic models that estimate environmental
concentrations of the chemical being assessed using labeled application
rates and methods for large-scale uses (e.g., agricultural and public
health uses).  However, because the uses assessed here are limited to
small-scale, residential uses, quantitative exposure analyses will be
conducted only for illustrative purposes to help characterize the
potential for risks to non-target species.

The allethrins have both indoor and outdoor residential (urban) uses.
For aquatic exposure, it will be assumed for outdoor urban uses in
general (applications to home lawns, gardens, parks, etc.) that runoff
water from rain and/or lawn watering may transport pesticide to storm
sewers and then directly to surface water.  In general, outdoor urban
uses are comprised of multiple, relatively small, temporally and
spatially variable applications; urban scenarios relevant to this use
pattern have not been developed for models used by EFED.  While runoff
in urban areas may be impacted by pesticides in runoff (water or
sediment) or inadvertent application to impermeable surfaces (driveways,
sidewalks or road surfaces adjacent to lawns), aquatic exposure modeling
will not be conducted due to the use pattern and the low overall volume
of usage.  Instead, for illustrative purposes, aquatic exposure will be
estimated based on dilution of the a.i. in the standard farm pond.

For example, based on a pond volume of 20 million liters and a total of
0.884 g of allethrin (a.i.) [the amount of a.i. in a typical can of
wasp/ant spray (e.g., Rainbow Wasp and Ant Spray; EPA Reg. No.:
13283-13)], and assuming no degradation or sorption, the resulting
concentration in the pond would be 0.0442 ppb.  In order to achieve an
exposure concentration equal to the toxic endpoints of concern for
freshwater invertebrates (LC50 = 2.1 ppb) and freshwater fish (LC50 =
7.9 ppb), it would require the direct spraying of approximately 48 and
179 cans into the pond, respectively.  To exceed the acute endangered
species LOC of 0.05 for aquatic animals would require the simultaneous
release into a standard farm pond of 2.4 cans (for freshwater
invertebrates) and 9 cans (for freshwater fish).

For terrestrial exposures,   SEQ CHAPTER \h \r 1 the application methods
for the allethrins include aerosol cans, foggers, mosquito coils, mats,
trigger sprayers, foams, and bait stations.  Therefore, there is a
potential for terrestrial exposure to non-target organisms through
direct application or spray drift.  EEC values used for terrestrial
exposure are typically derived from the Kenaga nomograph (  SEQ CHAPTER
\h \r 1 Hoerger and Kenaga, 1972), as modified by Fletcher et al.
(1994), using the T-REX model (version 1.4.1, 10/09/2008); however, the
allethrins do not have agricultural uses and cannot be modeled using the
standard terrestrial model generated for agricultural crops or turf.
Also, EFED does not currently have standard models for small-scale
outdoor urban uses.  Furthermore, the potential for the allethrins to
reach non-target terrestrial animals at levels approaching effect
concentrations is considered minimal based on the supported uses
(inclusive of use type, formulations, and application type and rates).
Therefore, terrestrial exposure modeling will not be used to directly
calculate standard risk quotients for the allethrins; instead, T-REX
will be used to help characterize expected exposure to terrestrial
animals.  Similarly, if plant data become available, TerrPlant (version
1.2.2, 12/26/2006) will be used to help characterize expected exposure
to terrestrial and semi-aquatic plants.

For example, the following type of analyses will be conducted.  Again,
considering a typical wasp/ant spray [e.g., Rainbow Wasp and Ant Spray
(EPA Reg. No.: 13283-13)].  At the highest calculated use rate (0.00032
lbs/ft2), the equivalent rate per acre is 13.76 lbs a.i./acre.  However,
this ‘application rate’ would be limited to the area treated as part
of the ‘spot treatment’ and would not apply to an actual acre.  To
reach the 13.76 lbs a.i./acre rate on an entire acre would require 7,242
cans of product.

Using the13.8 lb a.i./acre rate, several of the calculated avian RQs
using T-REX are higher than the acute risk and/or the acute endangered
species LOCs (RQs range from 2.58 for a 20g bird that eats short grass
to 0.02 for a 1,000g bird that eats fruits and pods) using upper bound
Kenaga values.  Again, however, these exposure estimates would be
limited to the area treated and not to an entire acre.  In fact, for any
of the avian RQs to reach the acute risk LOC of 0.5 requires an
application rate of 2.7 lb a.i./acre (requiring 1,421 cans for an entire
acre) using upper bound Kenaga values, and the only ‘weight/food
category’ that exceeds this LOC at this application rate is a 20g bird
that eats short grass.  Additionally, for any of the avian RQs to reach
the acute endangered species LOC of 0.1, using upper bound Kenaga
values, requires an application rate of 0.5 lb a.i./acre (requiring 263
cans for an entire acre), and, again, the only avian ‘weight/food
category’ that exceeds this LOC at this application rate is a 20g bird
that eats short grass.

Furthermore, an adult bobwhite quail weighing 206.4 g (MRID 123339)
would have to be gavaged with almost half a can of wasp spray [160 g
(5.6 ounces) of product], more than 75% of its body weight, to reach the
LD50 concentration of 2030 mg a.i./kg-bw.  For most birds, if their
entire daily diet was made up solely of the wasp spray, their allethrin
exposure levels would not reach the avian LD50 value; the exception is
for 20 g birds [20 g birds eat 22.8 g diet/day = 2,964 mg a.i./kg-bw;
100 g bird eats 64.9 g diet/day = 1687 mg a.i./kg b-w; 1000 g bird eats
291 g diet/day = 757 mg a.i./kg b-w].

	7.3.  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 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 the allethrins on non-target
animals is also collected from the Ecological Incident Information
System (EIIS; USEPA 2009).  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.  Incidents
reported in the aggregate incident reports and the Avian Incident
Monitoring System (AIMS) will also be searched.  AIMS is a database
administered by the American Bird Conservancy (it was partially funded
by the EPA).  It contains publicly available data on reported avian
incidents involving pesticides
(http://www.abcbirds.org/abcprograms/policy/pesticides/aims/aims/index.c
fm).

Where available, sub-lethal 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,
though, are limited to those endpoints that can be directly linked to
the Agency’s assessment endpoints of impaired survival, growth and
reproduction.    SEQ CHAPTER \h \r 1 The assessment of risk for direct
effects to non-target organisms makes the assumption that toxicity of
allethrins to birds is similar to terrestrial-phase amphibians and
reptiles.  The same assumption is made for fish and aquatic-phase
amphibians.

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.

	7.4.  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 the allethrins 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.
Typically 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 (LOC) (USEPA 2004).  These criteria are typically used
to indicate when a chemical’s use, as directed on the labels, has the
potential to cause adverse direct or indirect effects to non-target
organisms.  However, because the uses assessed here are limited to
small-scale, residential uses, exposure will not be quantitatively
estimated, but instead will be presented qualitatively based on
potential allethrin use patterns, fate properties, and toxicity.
Limited quantitative exposure analysis will be conducted for
illustrative purposes in further characterizing potential risks (see the
examples above).  In addition, incident data from EIIS, aggregate
incident reports, and AIMS will be considered as part of the risk
characterization.

	7.5.   Uncertainties

An anticipated uncertainty in the assessment relates to estimating the
environmental exposures that will result from the use of the allethrins.
 Standard EECs will not be calculated because use rates typically
reported for agricultural chemicals (i.e., lb a.i./acre) are not
applicable for allethrin end use products, and, in most cases, maximum
application rates cannot be calculated based on the label.  Even if
standard application rates were available, it is not feasible to
estimate exposure, given the use types (e.g., foggers, wasp nest sprays,
etc.), or the magnitude of use in a given area (e.g., a neighborhood or
campsite) at a given time, without excessive assumptions.  Also, the
allethrins do not have agricultural uses and cannot be modeled using the
standard Agency scenarios generated for agricultural crops or turf.

Although this assessment focuses on esbiol, esbiothrin, bioallethrin,
and pynamin forte, data from all of the allethrin compounds (including
allethrin) will be bridged.  This data bridging will be conducted since
the allethrin compounds are structurally nearly identical except in the
ratios and amounts of the two major isomers (d-trans chrysanthemic acid
ester of d-allethrolone and d-trans chrysanthemic acid ester of
l-allethrolone). The registrant has reported that the d-trans d- isomer
is more insecticidally active than the other main allethrin isomers;
however, no side-by-side comparisons of the main isomers are available.
Additionally, no information is available regarding the toxicity of
d-trans (relative to the other allethrin isomers) to non-insect taxa.
Because of these uncertainties and the fact that the available toxicity
data for different taxa are mixed as to whether the allethrins with the
higher percentages of d-trans are more toxic than allethrins with lower
percentages, it will be assumed in this assessment that all of the
allethrins are equipotent in the absence of conclusive evidence
suggesting otherwise.  Additionally, to more fully characterize the
environmental fate and transport of the allethrins, some of the data for
the structurally similar but naturally occurring compound pyrethrin 1
will be considered in addition to the submitted data for the allethrins.
 Using surrogate data in the absence of direct data on the active
ingredient being assessed will decrease confidence in the assessment.

Many end-use products that contain an allethrin also contain other
residual pyrethroids or insecticide synergists, such as piperonyl
butoxide.  Piperonyl butoxide is known to increase the sensitivity of
aquatic and terrestrial taxa to pyrethroids (Adams, 1998; Casida and
Quistad, 1995; Federle and Collins, 1976), however, the magnitude of its
synergistic effects when mixed with allethrins is not known.

Additionally, the allethrins can cause paralysis in animals at lower
concentrations than those resulting in mortality, and such paralysis
could lead to death not directly related to the toxicity of the compound
(e.g., via predation).  Therefore, the acute endpoints used in the
assessment which do not account for such sub-lethal effects (i.e., LC50
or LD50) may not be conservative in this respect.

A variety of terrestrial and aquatic organisms are more sensitive to
pyrethroids at lower temperatures (i.e., pyrethoids have negative
temperature coefficients of toxicity) (e.g., Cremlyn 1978; Hill 1985;
Li, et al. 2006); however, the magnitude of the effects of temperature
on allethrin toxicity is not known at this time.

7.6	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
the allethrins.  The assessment will be conducted in accordance with the
Overview Document (USEPA 2004), provisions of the ESA, and the
Services’ Endangered Species Consultation Handbook (USFWS/NMFS 1998).

The assessment of effects associated with the registration of the
allethrins will be 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.  In the case of a
nationwide risk assessment conducted under Registration Review, if any
risks are identified for listed species, the action area will encompass
the entire U.S. and its territories.  The purpose of defining the action
area as the entire U.S. and its territories is to ensure that the
initial area of consideration encompasses all areas where the pesticide
may be used now and in the future, including the potential for off-site
transport via spray drift and downstream dilution.  Additionally, the
concept of a nationwide action area takes into account the potential for
direct and indirect effects and any potential modification to critical
habitat based on ecological effect measures associated with reduction in
survival, growth, and reproduction, as well as the full suite of
sublethal effects available in the effects literature.

7.7.  Drinking Water Assessment

Because of the relatively limited use of the compound as an
aerosol/fogger spot treatment in residential settings, there is a low
likelihood of the compound contaminating human drinking water sources,
so a drinking water assessment will not be conducted to support a human
dietary risk assessment for the allethrins.

7.8.  Preliminary Identification of Data Gaps

		7.8.1.  Fate

There are no outstanding environmental fate data gaps for the
allethrins, assuming the validity of the Agency’s approach to bridging
data among different compounds in this group.  A summary of the
available data is presented in Table 7.1.  While terrestrial field
dissipation and aquatic metabolism studies are normally required for all
terrestrial uses, based on the current labeled uses which are mainly
indoor and limited-scale outdoor uses, these are not considered data
gaps at this time.  This determination of data gaps is based on OPP’s
expectation that the uses will not expand beyond the limited
spot-treatments in residential settings.  However, if the use were to
expand, the data needs would also.

TABLE 7.1.  Summary of Environmental Fate Data Requirement Table for
the Allethrins and Remaining Data Gaps.

	No	These data are not required under 40 CFR for indoor or
residential outdoor uses.

835.4300	Aerobic aquatic metabolism	No Data		No	These data are not
required under 40 CFR for indoor or residential outdoor uses.

835.4400	Anaerobic aquatic metabolism	No Data		No	These data are not
required under 40 CFR for indoor or residential outdoor uses.

835.1230

835.1240	Adsorption/ desorption and leaching	41900401	Acceptable 	No
Study on d-trans allethrin.

835.1410	Laboratory volatility	No Data		No	These data are not
required under 40 CFR for indoor or residential outdoor uses.

835.6100	Terrestrial field dissipation	No Data		No	These data are not
needed for this assessment based on the limited scale of the labeled
outdoor uses.

	Analytical method in soil	No Data	

835.6200	Analytical method in water	No Data		No	These data are not
needed for this assessment based on the limited scale of the labeled
outdoor uses.

850.1730	Fish bioconcentration	No Data		No	These data are not
required under 40 CFR for indoor or residential outdoor uses.

7.8.2.  Effects Data for the Allethrins

Although submissions have been made to provide data on the effects of
the allethrins to aquatic and terrestrial organisms, data gaps still
exist (Tables 7.2-7.4).  No allethrin toxicity data are available for
estuarine/marine animals.  Data are also lacking on chronic toxicity for
all taxa except mammals (i.e., birds, reptiles, amphibians, fish,
aquatic invertebrates, or terrestrial invertebrates).  Furthermore, no
guideline studies have been submitted to evaluate the effects of
allethrin exposure on plants.  These data gaps are discussed below.
This determination of data gaps is based on OPP’s expectation that the
uses will not expand beyond the limited spot-treatments in residential
settings.  However, if the use were to expand, the data needs would
likely also.

TABLE 7.2.  Summary of Available Ecological Effects Data for
Terrestrial Animals Exposed to Allethrins and Remaining Data Gaps.

Guideline	Description	Chemical (PC Code)	MRID/

Accession	Classification	Data Gap?	Comments

850.2100	Avian oral toxicity	Bioallehtrin (004003)	123339	Acceptable
Yes*	* These data are required under 40 CFR Part 158 but are not
available for any allethrin.  However, because the potential for the
allethrins to reach non-target terrestrial animals at levels approaching
effect concentrations is considered minimal based on previous
assessments and the supported uses; EFED does not recommend requesting
these data at this time.  However, if the uses for allethrins expand,
both the environmental fate and ecological effect data requirements
would likely expand as well.

** These data are required under 40 CFR Part 158 but are not available
for any allethrin.  Therefore, this is identified as a data gap.  Since
there is no precautionary honey bee language on allethrin product
labels, EFED recommends requesting a honey bee toxicity of residues on
foliage study.

850.2200	Avian dietary toxicity 	Pynamin forte (004005)	27548	Acceptable
No

	850.2300	Avian reproduction	None	None	Not applicable	Yes*

	850.3020	Honeybee acute contact toxicity	Allethrin (004001)	162751
Supplemental	No

	850.3030	Honey bee toxicity of residues on foliage	None	None	Not
applicable	Yes**

TABLE 7.3.  Summary of Available Ecological Effects Data for Aquatic
Animals Exposed to the Allethrins and Remaining Data Gaps.

Guideline	Description	Chemical (PC Code)	MRID/ Accession	Classification
Data Gap?	comments

850.1075	Freshwater fish –

Acute toxicity 	Esbiol (004004)	40098001	Supplemental	No	* These data
are required under 40 CFR Part 158 but are not available for any
allethrin.  However, because the potential for the allethrins to reach
non-target aquatic animals at levels approaching effect concentrations
is considered minimal based on previous assessments and the supported
uses; EFED does not recommend requesting these data at this time.

However, if the uses for allethrins expand, both the environmental fate
and ecological effect data requirements would likely expand as well.

850.1075	Saltwater fish –

Acute toxicity 	None	None	Not applicable	Yes*

	850.1010	Freshwater invertebrates –

Acute toxicity	Allethrin (004001)	40098001	Supplemental	No

	850.1025

850.1035	Saltwater invertebrates –

Acute toxicity 	None	None	Not applicable	Yes*

	850.1300	Freshwater  invertebrate –

 life cycle test	None	None	Not applicable	Yes*

	850.1350	Saltwater invertebrates –

life cycle test	None	None	Not applicable	Yes*

	850.1400	Freshwater fish –

early life stage test	None	None	Not applicable	Yes*

	850.1400	Saltwater fish –

early life stage test	None	None	Not applicable	Yes*

TABLE 7.4.  Available Ecological Effects Data for Plants Exposed to the
Allethrins and Remaining Data Gaps.

Guideline	Description	MRID	Classification	Data Gap?	comments

850.4100	Terrestrial Plant toxicity: Tier I seedling emergence	None	Not
applicable	No	* For terrestrial plants, Tier II vegetative vigor and
seedling emergence studies are required when potential concerns are
triggered.  Due to the 13 incidents identified in the Agency’s
aggregated incident reports (all terrestrial plant incidents involving
d-trans allethrin; PC Code: 004003), EFED recommends requesting Tier II
terrestrial plant studies using d-trans allethrin.

** For aquatic plants, toxicity studies are required for vascular and
non-vascular plants; currently such data are not available for any
allethrin.  Because the potential for the allethrins to reach non-target
aquatic environments at levels approaching effect concentrations [even
for known sensitive taxa (e.g., aquatic invertebrates)] is considered
minimal based on previous assessments and the supported uses, EFED does
not recommend requesting these data at this time.

850.4225	Terrestrial Plant toxicity: Tier II seedling emergence	None	Not
applicable	Yes*

	850.4150	Terrestrial Plant toxicity: Tier I vegetative vigor	None	Not
applicable	No

	850.4250	Terrestrial Plant toxicity: Tier II vegetative vigor	None	Not
applicable	Yes*

	850.5400	Aquatic Plant Growth: algae	None	Not applicable	Yes**

	850.4400	Aquatic Plant Growth: vascular plants	None	Not applicable
Yes**

Avian Acute Oral and Reproduction Toxicity

Acceptable acute avian oral toxicity data were submitted for exposures
of bobwhite quail to bioallethrin (PC code 004003); however, data are
not available for passerines, which are required under the new 40 CFR
Part 158 (Oct. 26, 2007) data requirements for conventional pesticides
(72 FR 60934; USEPA, 2007).  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.  Additionally, avian
reproduction data are required under the pesticide data requirements.
However, because the potential for the allethrins to reach non-target
terrestrial animals at levels approaching effect concentrations is
considered minimal based on previous assessments and the supported uses;
EFED does not recommend requesting the acute or chronic avian toxicity
data at this time.

Honey Bee Toxicity of Residues on Foliage

Under the 40 CFR Part 158 (July 1, 2009) data on honey bee toxicity of
residues on foliage are required (OPPTS 850.3030) when the acute honey
bee contact LD50 <11 µg/bee and the use pattern(s) indicate(s) that
honey bees may be exposed to the pesticide.  The acute contact LD50 for
methiocarb is 3.4 µg a.i./bee (allethrin, MRID 162751).  Therefore,
this is identified as a data gap.  Since there is no precautionary honey
bee language on allethrin product labels (at least on a subset of labels
reviewed for such language), EFED recommends requesting a honey bee
toxicity of residues on foliage study.  EFED will assume risks to
terrestrial invertebrates if honey bee toxicity of residues on foliage
data are not submitted.

Aquatic Animal Acute and Chronic Toxicity Studies

Acceptable acute toxicity data were submitted for allethrins and
freshwater fish and invertebrates.  Chronic data are not available for
freshwater animals and no toxicity data (acute or chronic) are available
for estuarine/marine animals.  These data are required under 40 CFR Part
158 (Oct. 26, 2007) data requirements for conventional pesticides (72 FR
60934; USEPA 2007).  However, because the potential for the allethrins
to reach non-target aquatic animals at levels approaching effect
concentrations is considered minimal based on previous assessments and
the supported uses; EFED does not recommend requesting the acute or
chronic toxicity data for aquatic animals at this time.

Terrestrial Plant and Aquatic Plant Studies

Aquatic (both vascular and non-vascular species) and terrestrial plant
toxicity studies and associated risk analysis of plants are required for
registration of pesticides with outdoor uses (CFR Part 158).  For
terrestrial plants, Tier II studies (OPPTS Guidelines 850.4225 and
850.4250) are required when potential concerns are triggered (i.e., when
there is some indication that there may be significant toxicity to
plants).  Thirteen allethrin incidents involving plants have been
reported to the Agency in aggregated incident reports (all terrestrial
plant incidents involving d-trans allethrin; PC Code: 004003; occurring
from 1995 to 2005) (see APPENDIX F).  Therefore, the requirement for
Tier II plant studies (vegetative vigor and seedling emergence) for the
allethrins is triggered by these incidents.  Based of the chemical’s
mode of action, allethrin is not expected to affect plants, however,
there is uncertainty regarding this due to the reported plant incidents.
 Unless additional information on these aggregated incidents becomes
available, they will be assumed to be representative of registered uses
of the allethrins in the risk assessment.  If toxicity data for
terrestrial plants are not submitted for allethrins, EFED will assume
risk for terrestrial plants.

Additionally, toxicity data for vascular and non-vascular aquatic plants
(Tier I, OPPTS Guideline 850.4400 and 850.5400) are not currently
available for any allethrin.  However, because the potential for the
allethrins to reach non-target aquatic environments at levels
approaching effect concentrations [even for known sensitive taxa (e.g.,
aquatic invertebrates)] is considered minimal based on previous
assessments and the supported uses, EFED does not recommend requesting
these data at this time.

8.  References

2004-2005 Water and Sediment Quality Monitoring Data Summary for Chollas
Creek, Final Report. (2006).  Response to Monitoring in Chollas Creek,
Investigation Order No. R9-2004-0277.  Proposition 13, PRISM Grant
Agreement No. 04-17-559-0.  San Diego Region Integrated

	Pest Management (IPM) Education and Outreach Project.

ATSDR (2003).  Toxicological Profile for Pyrethrins and Pyrethroids.
United States Department of Health and Human Services, Public Health
Service, Agency for Toxic Substances and Disease Registry. Atlanta, GA.
September 2003.

Adams, M. (1998).  The use of piperonyl butoxide in grain protection.
In Piperonyl Butoxide.  Edited by D. Glynne Jones.  Academic Press; San
Diego, CA. Pp. 261 – 282.

Agency for Toxic Substances and Disease Registry (ATSDR). (2003).
Toxicological Profile for Pyrethrins and Pyrethroids.  Atlanta, GA; US
Department of Health and Human Services.  Public Health Service.

Casida, J.E., and G. B. Quistad (1995).  Pyrethrum Flowers: Production,
Chemistry, Toxicology, and Uses. Oxford Univ. Press; New York.  Pp. 356.

Cremlyn, R.  (1978). Pesticides: Preparation and Mode of Action, John
Wiley and Sons, Chichester, UK.

Dureja P., J.E. Casida, and L.O. Ruzo (1984).  Dinitroanilines as
photostabilizers for pyrethroids.  J Agric Food Chem, 32: 246-50.

Federle, P. F., and W. J. Collins (1976). Insecticide toxicity to three
insects from Ohio ponds. Ohio J. Sci., 76: 19-24.

Fletcher, J.S., J.E. Nellessen, and T.G. Pfleeger  (1994).  Literature
review and evaluation of the EPA food-chain (Kenaga) nomogram, an
instrument for estimating pesticide residues on plants.  Environ. Tox.
Chem. 13:1383-1391.

Franke C., G. Studinger, G. Berger, S. Bohling, U. Bruckman, D.
Cohors-Fresenborg, and U. Johncke (1994). The assessment of
bioaccumulation. Chemosphere 29: 1501-14.

Goring, C.A.I., D.A. Laskowki, J.H. Hamaker, and R.W. Meikle (1975).
Principles of pesticide degradation in soil.  In Environmental Dynamics
of Pesticides, R. Haque and V.H. Freed, eds.  Plenum Press; New York.
Pp. 135-172

Hazardous Substances DataBank (  HYPERLINK "http://toxnet.nlm.nih.gov"
http://toxnet.nlm.nih.gov  ) (2006).  Entries for allethrin, resmethrin
and cypermethrin.

Hill, I.R. (1985).  Effects on non-target organisms in terrestrial and
aquatic environments. In: J.P. Leahey, Editor, The Pyrethroid
Insecticides, Taylor and Francis, London, UK.

  SEQ CHAPTER \h \r 1 Hoerger, F. and E. E. Kenaga  (1972).  Pesticide
Residues on Plants: Correlation of Representative Data as a Basis for
Estimation of their Magnitude in the Environment.  In F. Coulston and F.
Korte, eds., Environmental Quality and Safety: Chemistry, Toxicology,
and Technology, Georg Thieme Publ., Stuttgart, West Germany, pp. 9-28.

Li, Haiping, Tao Feng, Pei Liang, Xueyan Shi, Xiwu Gao and Hui Jiang
(2006).  Effect of temperature on toxicity of pyrethroids and
endosulfan, activity of mitochondrial Na+–K+-ATPase and
Ca2+–Mg2+-ATPase in Chilo suppressalis (Walker) (Lepidoptera:
Pyralidae).  Pesticide Biochemistry and Physiology, 86(3): 151-156.

Mayer, D., and C. Johansen (1990). Pollinator Protection: A Bee &
Pesticide Handbook. Wicwas Press; Cheshire, Conn. Pp. 161.

  SEQ CHAPTER \h \r 1 USEPA (1986).  Bioallethrin Registration Standard:
Selection of Isomers To Be Included in the Standard.  From Pamela Hurley
(HED) to Richard King (RD) through Edwin Budd (HED), Robert Zendzian
(HED) and William Burman (HED).  TXR # - 0052388.

USEPA (1987).  Bioallethrin, Toxicology Chapter of the Registration
Standard.  From Pamela Hurley (HED) to Richard King (RD) through Robert
Zendziah (HED) and William Burnam (HED).

	Record No.: 005862.

USEPA (1988).  Guidance for the Reregistration of Pesticide Products
Containing Allethrin Stereoisomers as the Active Ingredient.  EPA
540/RS-88/063.  Office of Pesticide Programs, United States
Environmental Protection Agency, Washington, DC. March 24, 1988.

  SEQ CHAPTER \h \r 1 USEPA (1997).  Allethrin Stereoisomers: AgrEvo
Environmental Health (AEH) Rebuttal of Agency requirements Concerning
the Test Substance for Plant Metabolism Studies.  From William O. Smith
(HED) to Paula Deschamp (HED).  DP Barcode - 222638.

USEPA (1998).  Guidelines for Ecological Risk Assessment.  Risk
Assessment Forum, Office of Research and Development,  Washington, D.C.
EPA/630/R-95/002F.  April 1998.   HYPERLINK
"http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759"
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759

USEPA (2002).  Guidance for Selecting Input Parameters in Modeling the
Environmental Fate and Transport of Pesticides, Version II.  US
Environmental Protection Agency, Washington DC.  Online at:
http://www.epa.gov/oppefed1/models water/input_guidance2_28_02.htm.

USEPA (2004).  Overview of the Ecological Risk Assessment Process in the
Office of Pesticide Programs.  U.S. Environmental Protection Agency,
Office of Prevention, Pesticides and Toxic Substances, Office of
Pesticide Programs, Washington DC.  January 23, 2004.

USEPA (2006).  Standardized Soil Mobility Classification Guidance.  U.S.
Environmental Protection Agency, Office of Prevention, Pesticides and
Toxic Substances, Office of Pesticide Programs, Environmental Fate and
Effects Division, Memorandum.  April 21, 2006.

USEPA (2007a).  Response to Comments (Phase 3) and Revised Environmental
Fate and Ecological Risk Assessment in Support of the Reregistration of
the Allethrins.  Office of Pesticide Programs, United States
Environmental Protection Agency, Washington, DC. April 4, 2007.

USEPA (2007b).  Reregistration Eligibility Decision for Allethrins.
Office of Pesticide Programs, United States Environmental Protection
Agency, Washington, DC. June 29, 2007.

USEPA (2007c).  Ecological Incident Information System.   HYPERLINK
"http://www.epa.gov/espp/consultation/ecorisk-overview.pdf"
http://www.epa.gov/espp/consultation/ecorisk-overview.pdf

USEPA (2007d).  40 CFR Part 158.  Pesticides; Data Requirements for
Conventional Chemicals: Final Rule. 72 FR 60934.  October 26, 2007.

USEPA (2007e).  ECOTOXicology Database.  Office of Research and
Development National Health and Environmental Effects Research
Laboratory’s (NHEERL’s) Mid-Continent Ecology Division (MED).
HYPERLINK "http://cfpub.epa.gov/ecotox/"  http://cfpub.epa.gov/ecotox/ .

USEPA (2009).  Reregistration Eligibility Decision for Allethrins
(Revised May 2009).  Office of Pesticide Programs, United States
Environmental Protection Agency, Washington, DC..

U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries
Service (NMFS) (1998).  Endangered Species Consultation Handbook:
Procedures for Conducting Consultation and Conference Activities Under
Section 7 of the Endangered Species Act.  Final Draft.  March 1998.

U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries
Service (NMFS) (2004).  Services’ Evaluation Memorandum on the
USEPA’s (2004) Overview Document.

Worthing, C. R. (ed.) (1979).  Pesticide Manual. 6th ed. British Crop
Protection Council, l979; Worcestershire, England. Pp.7.

SUBMITTED ENVIRONMENTAL FATE STUDIES:

MRID:

MRID 41504401

Estigoy, L., K. Shepler, and L.O. Ruzo.  1990.  Hydrolysis of
[alc-14C]-d-trans-allethrin at pH 5, 7 and 9.  PTRL Report No. 196W-1.
Unpublished study performed by Pharmacology and Toxicology Research
Laboratory-West, Richmond, CA, and submitted by Sumitomo Chemical
Company, Ltd., Osaka, Japan.

MRID 41504402

Chari, S., K. Shepler, and L.O. Ruzo.  1990.  Sunlight photodegradation
of [alc-14C]-d-trans-allethrin in a buffered aqueous solution at pH 5.
PTRL Report No. 197W-1.  Unpublished study performed by Pharmacology and
Toxicology Research Laboratory, Richmond, CA, and submitted by Sumitomo
Chemical Company, Ltd., Osaka, Japan.

MRID 41900401

Dykes, J.  1990.  Soil/sediment adsorption-desorption with
14C-allethrin.  ABC Final Report No. 38539.  Unpublished study performed
by Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO, and
submitted by Roussel Bio Corporation, Lincoln Park, NJ, for Sumitomo
Chemical Company, Ltd., Osaka, Japan.

MRID 42336501

Schmidt, J.M.  1992a.  Aerobic soil metabolism study of
[Acid-14C]-d-trans-Allethrin.  Project No. 38484.  Unpublished study
performed by ABC Laboratories, Inc., Columbia, MO, and submitted by
Sumitomo Chemical Company, Ltd., Osaka, Japan.

MRID 42336502

Schmidt, J.M.  1992b.  Aerobic soil metabolism study of
[Alc-14C]-d-trans-Allethrin.  Project No. 38484.  Unpublished study
performed by ABC Laboratories, Inc., Columbia, MO, and submitted by
Sumitomo Chemical Company, Ltd., Osaka, Japan.

SUBMITTED EFFECTS STUDIES:

MRID:

MRID: 27546

Raltech Scientific Services, Incorporated (1979). Aquatic Inverte- brate
Toxicity Study--Daphnia: RT No. 8084240. (Unpublished study received Dec
13, 1979 under 1021-1422; submitted by McLaughlin, Gormley, King Co.,
Minneapolis, Minn.; CDL:241520-B).

MRID: 27548

Beavers, J.B.; Fink, R.; Brown, R. (1978). Final Report: Eight-Day
Dietary LC50--Mallard Duck: Project No. 163-104. (Unpublished study
received Dec 13, 1979 under 1021-1422; prepared by Wild- life
International, Ltd. in cooperation with Washington College, submitted by
McLaughlin, Gormley, King Co., Minneapolis, Minn.; CDL:241520-D).

MRID: 31368

Rausina, G. (1974). Report to McLaughlin Gormley King Company: Four- Day
Static Fish Toxicity Studies with X-2840-74 in Rainbow Trout and
Bluegills: IBT No. 621-05281. (Unpublished study received Dec 17, 1975
under 1021-88; prepared by Industrial Bio-Test Lab- oratories, Inc.,
submitted by McLaughlin, Gormley, King Co., Minneapolis, Minn.;
CDL:221996-M).

MRID: 31369

Fletcher, D. (1974). Report to McLaughlin Gormley King Company: 8- Day
Dietary LCI50^ Study with X-2840-74 in Mallard Ducklings: IBT No.
651-05280. (Unpublished study received Dec 17, 1975 un- der 1021-88;
prepared by Industrial Bio-Test Laboratories, Inc., submitted by
McLaughlin, Gormley, King Co., Minneapolis, Minn.; CDL:221996-N).

MRID: 47080

Fletcher, D. (1973). Report to McLaughlin Gormley King Company: 8-Day
Dietary LCI50^ Study with S-Bioallethrin in Bobwhite Quail: IBT No.
651-02851. (Unpublished study received Apr 11, 1973 under unknown amdin.
no.; prepared by Industrial Bio-Test Laboratories, Inc., submitted by
McLaughlin, Gormley, King Co., Minneapolis, Minn.; CDL:133033-A).

MRID: 49254

Atkins, E.L., Jr.; Anderson, L.D. (1967). Toxicity of Pesticides and
Other Agricultural Chemicals to Honey Bees: Laboratory Studies. By Univ.
of California--Riverside, Dept. of Entomology. River- side, Calif.: UC,
Agricultural Extension Service. (M-16; sub- mitter report no. 22259,
also~In~unpublished submission received Mar 22, 1976 under 3125-71;
submitted by Mobay Chemical Corp, Kansas City, Mo.; CDL:224114-K).

MRID: 55509

Fletcher, D. (1974). Report to Mc Laughlin Gormley King Company: 8-Day
Dietary LCI50^ Study with X-2840-74 in Mallard Ducklings: IBT No.
651-05280. (Unpublished study received Dec 17, 1975 under 1021-88;
prepared by Industrial Bio-Test Laboratories, Inc., submitted by
McLaughlin, Gormley, King Co., Minneapolis, Minn.; CDL:221996-N).

MRID: 122546

Mauck, W.; Olson, L.; Marking, L. (1976). Toxicity of natural pyrethrins
and five pyrethroids to fish. Archives of Environ- mental Contamination
and Toxicology 4:18-29. (Also In unpub- lished submission received Feb
11, 1977 under 1021-24; submitted by McLaughlin Gormley King Co.,
Minneapolis, MN; CDL:228070-A).

MRID: 123339

Fink, R.; Beavers, J.; Grimes, J.; et al. (1978). Acute Oral LD50:
Bobwhite Quail: D-Trans Allethrin, Technical: Project No. 163- 106.
Final rept. (Unpublished study received Feb 8, 1979 under 1021-1217;
prepared by Wildlife International, Ltd., submitted by McLaughlin
Gormley King Co., Minneapolis, MN; CDL:238863-A).

MRID: 162751

Stevenson, J. (1968) Laboratory studies on the acute contact and oral
toxicities of insecticides to honeybees. Ann. appl. Biol. 61:467-472.

MRID: 40098001

Mayer, F.L., and M.R. Ellersieck (1986). Manual of Acute Toxicity:
Interpretation and Data Base for 410 Chemicals and 66 Species of
Freshwater Animals. United States Department of the Interior, U.S. Fish
and Wildlife Service, Resource Publication 160.

MRID: 151449

Glomot, R. (1979). Esbiothrin: Acute Oral Toxicity Study in the Rat:
Ref. RU-EBT-79828/A and Ref. 79.828. Unpublished study prepared by
Roussel Uclaf. 27 p.

MRID: 41246801

Hoberman, A. (1989). Reproductive Effects of Pynamin Forte Administered
Orally in Feed to Crl:COBS CD (SD)BR Rats for Two Genera- tions: Argus
Research Laboratories Protocol 1119-002. Unpub- lished study prepared by
Argus Research Laboratories, Inc. 1203 p.

APPENDIX A:  Toxicity Data for the Allethrins:

TABLE 1.  Submitted Toxicity Data for Allethrins:  Aquatic Organisms:

SPECIES	CHEM./

(PC CODE)	END-POINT	DUR-ATION (hrs)	CONC. MEAN (ppb)	EXPO-SURE TYPE
CATEGORY	MRID #

Freshwater Fish

Salmo gairdneri

Rainbow Trout	Allethrin/

004001	LC50	96	19.0	Static (S)	Supplemental1	40098001

	Bioallethrin/

004003	LC50	96	13.9

(11.8 – 17.9)	S	Supplemental	40098001

LC50	96	17.5

(13.1 – 23.4)	S	Supplemental	40098001

LC50	96	9.7

(8.0 – 11.6)	Flow-through (F)	Supplemental	40098001

LC50	96	--	S	Invalid2	31368

Oncorhynchus mykiss

Steelhead Trout	Bioallethrin/

004003	LC50	96	17.5

(13.1 – 23.4)	S	Supplemental	122546

LC50	96	9.7

(8.0 – 11.6)	F	Supplemental	122546

Oncorhynchus kisutch

Coho Salmon	Bioallethrin/

004003	LC50	96	22.2

(20.6 – 23.9)	S	Supplemental	40098001

LC50	96	2.6*

(1.8 – 3.5)	F	Supplemental	40098001

LC50	96	22.2

(20.6 – 23.9)	S	Supplemental	122546

LC50	96	9.4

(7.91 – 11.2)	F	Supplemental	122546

Salvelinus namaycush

Lake Trout	Bioallethrin/

004003	LC50	96	17.3

(14.9 – 20.0)	S	Supplemental	40098001

LC50	96	16.0*

(14.3 – 17.8)	F	Supplemental	40098001

Esox lucius

Northern Pike	Bioallethrin/

004003	LC50	96	3.3*

(3.0 – 3.6)	F	Supplemental	40098001

  SEQ CHAPTER \h \r 1 Lepomis macrochirus

Bluegill Sunfish	Allethrin/

004001	LC50	96	56.0	S	Supplemental	40098001

	Bioallethrin/

004003	LC50	96	47.0

(39.8 – 55.5)	S	Supplemental	40098001

LC50	96	47.0

(40.0 – 55.2)	S	Supplemental	40098001

LC50	96	35.0

(31.4 – 39.0)	S	Supplemental	40098001

LC50	96	56.0

(47.3 – 66.3)	S	Supplemental	40098001

LC50	96	56

(44.5 – 70.5)	S	Supplemental	40098001

LC50	96	60.0

(52.1 – 69.1)	S	Supplemental	40098001

LC50	96	49.0

(42.7 – 56.2)	S	Supplemental	40098001

LC50	96	49.0

(42.7 – 56.2)	S	Supplemental	40098001

LC50	96	42.5

(33.4 – 54.1)	S	Supplemental	40098001

LC50	96	22.5

(20.5 – 24.7)	F	Supplemental	40098001

LC50	96	40.0

(36.0 – 44.4)	7 day degra	Supplemental	40098001

LC50	96	34.3

(30.8 – 38.2)	7 day degra	Supplemental	40098001

LC50	96	74.0

(64.5 – 85.9)	7 day degra	Supplemental	40098001

LC50	96	--	S	Invalid2	31368

	Esbiol/

004004	LC50	96	23.6

(18.8 – 29.6)	S	Supplemental	40098001

LC50	96	27.6

(24.5 – 31.1)	S	Supplemental	40098001

LC50	96	39.0

(33.5 – 45.4)	S	Supplemental	40098001

LC50	96	30.0

(25.4 – 35.4)	S	Supplemental	40098001

LC50	96	36.0

(32.2 – 40.3)	S	Supplemental	40098001

LC50	96	>25	S	Supplemental	40098001

LC50	96	>25	S	Supplemental	40098001

LC50	96	33.8

(30.4 – 37.6)	7 day degra	Supplemental	40098001

LC50	96	44.3

(38.2 – 51.3)	7 day degra	Supplemental	40098001

LC50	96	53.8

(42.9 – 67.4)	7 day degra	Supplemental	40098001

  SEQ CHAPTER \h \r 1 Pimephales promelas

Fathead Minnow	Bioallethrin/

004003	LC50	96	48.0

(34.9 – 66.0)	F	Supplemental	40098001

LC50	96	69.0

(53.8 – 88.4)	F	Supplemental	40098001

	Esbiol/

004004	LC50	96	80.0

(65.9 – 97.1)	S	Supplemental	40098001

LC50	96	53.0

(35.8 – 78.3)	F	Supplemental	40098001

LC50	96	80.0

(65.9 – 97.1)	S	Supplemental	122546

Catostomus commersoni

White Sucker	Bioallethrin/

004003	LC50	96	12.4*

(10.5 – 14.6)	F	Supplemental	40098001

Ictalurus punctatus

Channel Catfish	Bioallethrin/

004003	LC50	96	>30.0	S	Supplemental	40098001

LC50	96	27.0

(22.4 – 32.6)	F	Supplemental	40098001

LC50	96	>30.1	S	Supplemental	122546

LC50	96	27.0

(22.4 – 32.6)	F	Supplemental	122546

	Esbiol/

004004	LC50	96	14.6

(10.1 – 21.0)	F	Supplemental	40098001

LC50	96	14.6

(10.1 – 21.1)	F	Supplemental	122546

Perca flavescens

Yellow Perch	Bioallethrin/

004003	LC50	96	9.9*

(9.17 – 10.7)	F	Supplemental	40098001

LC50	96	9.9*

(9.17 – 10.7)	F	Supplemental	122546

	Esbiol/

004004	LC50	96	7.8

(6.5 – 9.4)	S	Supplemental	40098001

LC50	96	7.8

(6.5 – 9.3)	S	Supplemental	122546

Micropterus dolomieui

Smallmouth Bass	Bioallethrin/

004003	LC50	96	7.7*

(5.8 – 10.2)	F	Supplemental	40098001

Micropterus salmoides

Largemouth Bass	Bioallethrin/

004003	LC50	96	>12*	F	Supplemental	40098001

Freshwater Invertebrates

Daphnia pulex

Waterflea	Allethrin/

004001	EC50	48	21.0

(19.0 -35.0)	S	Supplemental	40098001

	Bioallethrin/

004003	LC50	96	33

(10.0 – 70.0)	S	Invalid3	27546

	Esbiothrin/

004007	EC50	48	8.9

(7.5 – 11)	S	Acceptable	43235801

Simocephalus serrulatus

Waterflea	Allethrin/

004001	EC50	48	56

(40.0 -78.0)	S	Supplemental	40098001

Gammarus fasciatus

Scud	Allethrin/

004001	LC50	96	84

(5.0 – 12.0)	S	Supplemental	40098001

Pteronarcys californica

Stonefly	Allethrin/

004001	LC50	96	2.15

(1.5 – 2.9)	S	Supplemental	40098001

* Refers to data from fingerlings

1 Although results from Mayer and Ellersieck (1986) (MRID: 40098001)
have traditionally been considered ‘core’ or ‘acceptable’ by
EFED, EFED is currently re-evaluating the data from these studies to
determine if they meet current guideline requirements.  Until this is
completed, data from this volume will be considered ‘supplemental’.

2 These studies are deemed ‘invalid’ because they were performed by
Industrial BIO-TEST Laboratories, Inc., prior to 1976 when it was
determined that the laboratory falsified test results.

3 This study is invalid because: more than 10% of the controls died
during testing; the temperature during the study varied more than 1o C
(range: 17 – 21o C); information regarding pH, DO, and the actual
concentration of the chemical in test treatments was not provided; the
amount of a.i. in the technical was not provided.

- Italicized data are assumed to be duplicates (i.e., they are also
reported in Mayer and Ellersieck 1986, MRID 40098001)

4 In the Allethrin data table in Mayer and Ellersieck (1986), the 96-hr
LC50 for Gammarus fasciatus is listed as 11 µg/L with a 95% CI of 8.0 -
15.0 µg/L.  However, based on the original data source (Sanders, 1972;
ECOTOX ref.: 887), this is the LC50 for pyrethrum (and not allethrin).
The LC50 for allethrin should be 8 µg/L with a 95% CI of 5 - 12 µg/L.

5 In the Allethrin data table in Mayer and Ellersieck (1986), the 96-hr
LC50 for Pteronarcys californica is listed as 5.6 µg/L with a 95% CI of
4.9 – 6.4 µg/L.  However, based on the original data source (Sanders
and Cope, 1968; ECOTOX ref.: 889), this is the 48-hr LC50.  The 96-hr
LC50 for allethrin should be 2.1 µg/L with a 95% CI of 1.5 – 2.9
µg/L.

TABLE 2.  Submitted Toxicity Data for Allethrins:  Terrestrial
Organisms:

SPECIES	CHEM./

(PC CODE)	END-POINT	DUR-ATION (days)	CONC. MEAN 	EXPO-SURE TYPE	CATEGORY
MRID #

Birds

Colinus virginianus

Bobwhite Quail	Esbiol/ 004004	LC50	8	>5,000 mg/kg-diet	N/A	Invalid1
47080

	Bioallethrin/

004003	LD50	14	2030

mg/kg-bw

(1504 – 2738)	N/A	Acceptable	123339

Anas platyrhynchos

Mallard Duck	Bioallethrin/

004003	LC50	8	>5,000 mg/kg-diet	N/A	Invalid1	55509

LC50	8	>5,000 mg/kg-diet	N/A	Invalid1	31369

	Pynamin Forte/

004005	LC50	8	>5,620 mg/kg-diet	N/A	Acceptable	27548

Mammals

Laboratory rat	Esbiothrin/ 004007	LD50	14	378 mg/kg-bw	N/A	Acceptable
00151449

Laboratory rat	Pynamin Forte/

004005	NOAEL	2 generation	13 mg/kg-bw	N/A	Acceptable	41246801

Terrestrial Invertebrates

Apis mellifera

Honey Bee	Allethrin/

004001	LD50	1

(24 hr)	3.4 µg/bee	Contact	Supplemental	162751

LD50	1

(24 hr)	4.6 µg/bee	Oral	Invalid2	162751

LD50	1

(24 hr)	9.1 µg/bee	Oral	Supplemental	162751

LD50	2

(48 hr)	> 10 µg/bee	Contact	Supplemental	49254

1 These studies are deemed ‘invalid’ because they were performed by
Industrial BIO-TEST Laboratories, Inc., prior to 1976 when it was
determined that the laboratory falsified test results.

2 The results from several studies are reported; the data from 1965 are
classified as invalid because of   SEQ CHAPTER \h \r 1 the high rate of
control mortality noted in that year.

APPENDIX B:  Summary of the Allethrin Products Considered for
Registration Review (Based on Data Obtained from the Available LUIS
Reports):

TABLE 1.  Partial Listing of d-trans-Allethrin (004003) Products.

EPA Reg.No	%AI	Product Name

001021-01594	0.06	EVERCIDE RESIDUAL PRESSURIZED SPRAY 2523

001021-01607	0.054	EVERCIDE RESIDUAL PRESSURIZED SPRAY

001021-01697	0.045	EVERCIDE ROACH & ANT SPRAY 2622

001475-00159	0.25	WILLERT MOSQUITO COILS

073049-00085	0.15	SBP-1382/BIOALLETHRIN AQUEOUS PRESSURIZED SPRAY

073049-00102	0.15	SBP-1382/BIOALLETHRIN AQUEOUS PRESSURIZED SPRAY (PD
6.5)

073049-00135	0.1	SBP-1382/ESBIOTHRIN/P.B.O INSECTICIDE AQ. PRESS SPRAY
0.20% + 0.10% +

073049-00157	0.1	CYPERMETHRIN/FSBIOTHRIN/PIPERONYL BUTOXIDE
0.05%/0.1%/0.4% APS

073049-00191	0.25	FORD'S PERMICIDE CRACK & CREVICE SPRAY

073049-00362	0.15	ESBIOTHRIN MOSQUITO REPELLENT COILS

073049-00363	4.2	DERRINGER MOSQUITO MATS

TABLE 2.  Listing of Bioallethrin (004004) Products.

EPA Reg.No	%AI	Product Name

000004-00461	0.05	BONIDE CRAWLING INSECT KILLER

000432-00769	1.25	ALLEVIATE PLUS INSECTICIDE

000432-00841	0.15	DS 215 PROFESSEIONAL INSECTICIDE

000432-00848	0.15	DS 215 PROFESSEIONAL INSECTICIDE

000432-00871	20	ESBIOL 2000 INSECTICIDE

000498-00192	0.05	CHAMPION SPRAYON FLYING & CRAWLING INSECT KILLER
FORUMLA II

000499-00490	0.52	PRESCRIPTION TREATMENT BRAND TC ES CONTACT INSECTICIDE

000499-00495	0.067	TC-233

000499-00499	0.135	WHITMIRE MICRO-GEN TC-236

000769-00780	0.326	AFC ESBIOL 35

001270-00255	0.1	ZEP FLUSH 'N KILL DM

002724-00609	0.319	FARNAM REPEL-X PLUS

002724-00649	0.178	FARNAM-WIPE PLUS FLY PROTECTANT

002724-00680	0.05	SPI DELTAMETHRIN AEROSOL INSECTICIDE

006218-00043	0.35	ESBIOL FOGGING CONCENTRATE 2289

008848-00072	0.05	BLACK JACK DS 205 INSECT KILLER

009444-00126	0.135	PURGE CB S-312 INSECTICIDE

009688-00255	0.05	CHEMSICO WASP & HORNET KILLER DS

009688-00256	0.05	CHEMSICO AEROSOL INSECTICIDE DS

013283-00029	0.05	MULTI-BUG II

028293-00332	0.15	MULTI-BUG II

028293-00334	0.1	MULTI-BUG II

028293-00336	0.05	MULTI-BUG II

073049-00092	0.125	YOUR SBP-1382 BIOALLETHRIN .20% .125% AQUEOUS PRES
SPRAY FOR H&G

073049-00177	0.05	ZEP FLUSH 'N KILL DM

073049-00178	0.15	ZEP FLUSH 'N KILL DM

073049-00180	0.3	ZEP FLUSH 'N KILL DM

073049-00183	0.1	ZEP FLUSH 'N KILL DM

073049-00389	0.1	DSP 515 INSECTICIDE

073049-00390	0.05	CHEMSICO WASP & HORNET KILLER DS

073049-00459	0.05	ULTRA TEC DS YARD AND PATIO SPRAY

TABLE 3.  Listing of d-cis/trans Allethrin (004005) Products.

EPA Reg.No	%AI	Product Name

000121-00098	21.97	CUTTER INSECT REPELLENT EL

000498-00170	0.135	SPRAYPAK WASP & HORNET KILLER; FORMULA 2

003095-00026	0.25	PIC MOSQUITO COIL P.F.25

004822-00162	0.5	RAID PROFESSIONAL STRENGTH FLYING INSECT KILLER II

004822-00173	0.48	RAID PROFESSIONAL STRENGTH FLYING INSECT KILLER
FORMULA 4

004822-00181	0.239	RAID HOUSE + GARDEN BUG KILLER FORMULA 8

004822-00274	4.5	RAID FORMULA 274 INSECT KILLER

004822-00277	4.5	RAID FORMULA 277 INSECT KILLER

004822-00283	0.239	RAID HOUSE AND GARDEN BUG KILLER

004822-00284	0.143	RAID FORMULA 5 FLYING INSECT KILLER

004822-00286	0.143	RAID FORMULA 6 FLYING INSECT KILLER

004822-00287	0.143	RAID FLYING INSECT KILLER FORMULA 8

004822-00303	0.09	RAID FLYING INSECT KILLER FORMULA 9

004822-00319	0.095	RAID FLYING INSECT KILLER 12

004822-00327	0.095	RAID FLYING INSECT KILLER.

004822-00437	21.97	OFF! REPELLENT DH

004822-00469	21.97	REPELLENT LMO

004822-00513	0.1	RAID FLK FORMULA H1A

004822-00551	0.143	Raid Yard Guard Pld

005178-00005	0.25	KILMOS PF MOSQUITO REPELLENT COILS

005178-00010	0.25	KILMOS PF MOSQUITO REPELLENT STICKS

008112-00001	0.24	LION-TIGER MOSQUITO COILS

008842-00003	5.39	VAPE MAT

008842-00008	0.3	FUMAKILLA MOSQUITO COILS

010308-00014	5.8	VAPE MAT

010308-00015	6.85	PYAMIN FORTE 60 MOSQUITO MAT

010308-00016	23.75	VAPE MAT

010308-00017	0.31	PYNAMIN FORTE MOSQUITO COIL

022950-00014	0.25	COBRA PF MOSQUITO REPELLENT COILS

043917-00007	21.97	SPIRA AREA MOSQUITO REPELLENT

063376-00002	0.3	FAMILY MOSQUITO REPELLANT COILS

064537-00001	0.28	COCKSEC MOSQUITO COIL

071910-00002	21.97	THEMACELL MOSQUITO REPELLENT

071910-00003	21.97	THERMACELL MOSQUITO REPELLENT WITH EARTH SCENT

071910-00004	21.97	THERMACELL MOSQUITO REPELLENT CANDLE LANTERN

082539-00002	0.61	KAYARI AROMATIC MOSQUITO COILS

084538-00003	0.34	KAYARI AROMATIC MOSQUITO COILS

TABLE 4.  Listing of Esbiothrin (004007) Products.

Reg.No	%AI	Product Name

000270-00353	1	FASTACT 2 LONG-ACTING FLEA AND TICK DIP

009444-00126	0.3	PURGE CB S-312 INSECTICIDE

043917-00008	0.15	SPIRA PUNKS MOSQUITO COILS II (FORMULA 2)

APPENDIX C:  Chemical Structures of Allethrins.

Chemical Structure of Allethrin and of the Allethrin Isomers

d-trans chrysanthemic acid of d-allethrolone (most insecticidally active
isomer)

d-trans chrysanthemic acid of l-allethrolone

l-trans chrysanthemic acid of d-allethrolone

l-trans chrysanthemic acid of l-allethrolone

d-cis chrysanthemic acid of d-allethrolone

d-cis chrysanthemic acid of l-allethrolone

l-cis chrysanthemic acid of d-allethrolone

l-cis chrysanthemic acid of l-allethrolone

APPENDIX D:  Rat Acute Oral Toxicity Data for Formulated Products
Containing Allethrins: Based on Data from the OPP Integrative Hazard
Assessment Database (IHAD).

The following table includes 6-pack rat oral studies on allethrin
formulations from studies that were deemed acceptable by HED reviewer:

PRODUCT NAME/

REGISTRATION NO.	ACTIVE INGREDIENTS (PERCENT OF FORMULATED PRODUCT)	RAT
LD50	MRID

RAID WASP & HORNET KILLER AD/ 04822-00451 and SPIN OUT SPRAY/
67690-00028	- Chlorpyrifos (0.25%)

- d-Trans-Allethrin (0.20%)	>5,000 mg/kg	439144-07

4822-LRG RAID FIK FORMULA H1A/ 04822-00513 and RAID FLK FORMULA H1A/
04822-00513	- Permethrin (0.10%)

- Tetramethrin (0.35%)

- d-cis/trans allethrin (0.10%)	>5,000 mg/kg	44817404

D-PHENOTHRIN 2% INSECTICIDE AEROSOL/ 39398-00001 and NS 4/1 WB/
39398-00010	- Sumithrin (1.00%)

- By-products of sumithrin (0.08%)

- Pynamin forte (1.00%)

- By-products of allethrin (0.07%)

- Tetramethrin (1.00%)

- By-products of tetramethrin (0.05%)

- Repellent ( 3.00%)	>16 ml/kg	00054529

TC 96/ 00499-00412	-   SEQ CHAPTER \h \r 1 Pyrethrins (1.00%)

- d-trans allethrin (1.00%)

- Piperonyl butoxide (4.00%)

- n-Octyl bicycloheptene dicarboximide (4.33%)	4,890 mg/kg	430124-02

MULTICIDE FOGGING FORMULA 2170/ 01021-01402 and RAOG/ EVERCIDE®
Residual Pump Spray 2641/ 01021-01693	- Neo-pynamin (0.14%)

- Sumithrin (0.23%)

- MGK-264 (2.00%)

- Piperonyl butoxide (2.00%)

- d-trans allethrin (0.23%)	2,100 mg/kg	00111991

HARTZ 2 IN 1 FLEA KILLER FOR DOGS WITH ALLETHRIN/ 02596-00097 and HARTZ
2 IN 1 FLEA & TICK KILLER FOR CATS WITH ALLETHRIN/ 2596-00098	- d-trans
Allethrin (0.05%)

- 3-phenoxybenzyl-2,2dimethyl- 392-methylprop-l-enyl (0.05%)

- cylopropanecarboxylate N-octyl bicycloheptane dicarboximide
        (0.19%)	>5,000 mg/kg	41657302

BENGAL INDOOR FOGGER 92/<PHONE_NUMBER>6	- 3-phenoxybenzyl-(1RS, 3RS;1RS,
3SR)-2,2-dimethyl-3- (2-methylprop-l-enyl) cyclopropanecarboxylate
(2.00%)

- d-trans allethrin (1.50%)

- Piperonyl butoxide (0.40%)	> 5000 mg/kg	425098-03

  SEQ CHAPTER \h \r 1 Chemsico Aerosol Spray A/ 09688-00112	-   SEQ
CHAPTER \h \r 1 Permethrin (0.20%)						0.20

- d-trans Allethrin (0.05%)					0.05

-  n-alkyl (60% C14,  30% C16,   5% C12 , 5% C 18) dimethyl benzyl
ammonimum chlorides (40%) and n-alkyl (50% C12,   30% C1417% C16, 3%
C18) dimethyl ethylbenzyl ammonium chlorides (40%) (0.20%)	  SEQ CHAPTER
\h \r 1 >5050 mg/kg	  SEQ CHAPTER \h \r 1 43748404

CHEMSICO WASP & HORNET KILLER T/ 09688-00117	-   SEQ CHAPTER \h \r 1
Tralomethrin (0.01%)

- d-trans Allethrin (0.05%)	  SEQ CHAPTER \h \r 1 >5050 mg/kg	  SEQ
CHAPTER \h \r 1 440420-03

CHEMSICO AEROSOL INSECTICIDE LD/ 09688-00230	-   SEQ CHAPTER \h \r 1
d-trans Allethrin (0.05%)					0.05

- Lambda-Cyhalothrin (0.01%)	  SEQ CHAPTER \h \r 1 > 5000 mg/kg	  SEQ
CHAPTER \h \r 1 46466204.

DURSBAN WB05 III/ 62719-00197	-   SEQ CHAPTER \h \r 1 Chlorpyrifos
(0.49%)

- MGK-264 (0.17%)

- Piperonyl butoxide (0.10%)

- d-trans allethrin (0.05%)	> 5000 mg/kg	  SEQ CHAPTER \h \r 1 43994303

BENGAL WATER-BASED WASP & HORNET KILLER/ 68543-00011	-   SEQ CHAPTER \h
\r 1 Permethrin (0.10%)

- Piperonyl butoxide (0.40%)

- d-trans-Allethrin (0.05%)	> 5000 mg/kg	  SEQ CHAPTER \h \r 1 43338903

MULTICIDE SUMITHRIN 90% CONCENTRATE/ 01021-01383; MULTICIDE FOGGING
FORMULA 2170/ 01021-01402; BLACK FLAG PROFESSIONAL POWER HOUSE & GARDEN
INSECT KILLER-FORMULA "D”/ 69421-00013; and BLACK FLAG TRIPLE ACTIVE
BUG KILLER/ 69421-00014	- Neo-pynamin (1.00%)

- Sumithrin (1.67%)

- MGK-264 (15.0%)

- Piperonyl butoxide (15.0%)

- d-trans allethrin (1.67%)	2,100 mg/kg	00111991

BLACK FLAG ANT & ROACH KILLER FORMULA F/ 69421-00080	- d-trans allethrin
(0.09%)

- Permethrin (0.24%)

- Piperonyl butoxide (0.59%)	  SEQ CHAPTER \h \r 1 > 5000 mg/kg	  SEQ
CHAPTER \h \r 1 426966-06

SBP-1382/BIOALLETHRIN AQUEOUS PRESSURIZED SPRAY/ 73049-00085	-   SEQ
CHAPTER \h \r 1 Resmethrin (0.20%)

- d-trans-Allethrin (0.15%)	  SEQ CHAPTER \h \r 1 >5050 mg/kg	43261101

D-TRANS INTERMEDIATE 1808/ 01021-01026	- d-trans Allethrin (0.2%)

- Piperonyl butoxide (1.00%)

- Methoxychlor (1.00%)

- 2-Hydroxyethyl-n-octyl sulfide (0.95%)

- Petroleum distillate (5.99%)	11.3 ml/kg	00073659

BIORAM 7.5% - 12.5% INSECTICIDE CONCENTRATE/ 73049-00120	-   SEQ CHAPTER
\h \r 1 d-trans-Allenthrin (12.5%)

- Permethrin (7.50%)	  SEQ CHAPTER \h \r 1 4866 mg/kg	43260901

BIORAM 0.15% + 0.25% INSECTICIDE AQUEOUS PRESSURIZED SPRAY/ 73049-00121
- d-trans-Allenthrin (0.15%)

- Permethrin (0.25%)	> 5 ml/kg	242582 (ACC. No.)

SBP-1382/ ESBIOTHRIN/ PIPERONYL BUTOXIDE INSECT. CONC. 5%-10%-40% FORM
I/ 73049-00137 and DS 205 INSECTICIDE/ 73049-00177	-   SEQ CHAPTER \h \r
1 Piperonyl butoxide (40.0%)

- S-Bioallethrin (10.0%)

- Resmethrin (05.0%)	  SEQ CHAPTER \h \r 1 2132 mg/kg	43261001

BUG STOMPER 4-3/ 74621-00002	-   SEQ CHAPTER \h \r 1 Resmethrin (4.00%)

- d-trans allethrin (3.00%)	>   SEQ CHAPTER \h \r 1 5000 mg/kg	45267201

AMERICARE PET POUR-ON/ 04691-RLI	-   SEQ CHAPTER \h \r 1 Fenoxycarb
(5.00%)

- N-Octyl bicycloheptene Dicarboximide                      (4.00%)

- Piperonyl butoxide (2.00%)

- S-Bioallethrin (0.80%)

- Permethrin, mixed cis,trans (0.80%)	  SEQ CHAPTER \h \r 1 > 5010 mg/kg
43658203

DS 530 INSECTICIDE/ 73049-00180 and ULTRATEC KD AC/ 73049-00184	-   SEQ
CHAPTER \h \r 1 S-Bioallethrin (0.15%)

- Deltamethrin (0.02%)

	  SEQ CHAPTER \h \r 1 > 5050 mg/kg	44445904

DSP 0.25 - 2.5 - 25 AC/ 73049-00210	-   SEQ CHAPTER \h \r 1 Piperonyl
butoxide (25.0%)						25.00

- S-Bioallethrin (2.50%)							  2.50

- Deltamethrin (0.25%)	  SEQ CHAPTER \h \r 1 >5000   mg/kg	45034504

DS 0.572 - 2.86 OB AC/ 73049-00354	-   SEQ CHAPTER \h \r 1 S-
Bioallethrin (2.86%)

- Deltamethrin (0.57%)	  SEQ CHAPTER \h \r 1 5000 mg/kg	45066104

DS  105-OB Insecticide/ 73049-00390	-   SEQ CHAPTER \h \r 1 Deltamethrin
(0.01%)					0.01

- S-Bioallethrin (0.05%)	  SEQ CHAPTER \h \r 1 > 5000 mg/kg	45065705

DSP  515 Insecticide/ 73049-GIO	-   SEQ CHAPTER \h \r 1 Deltamethrin
(0.01%)					0.005

- S-Bioallethrin (0.10%)					0.100

- Piperonyl Butoxide (0.50%)	  SEQ CHAPTER \h \r 1 > 5000 mg/kg	45034604

RAID FORMULA 5 FLYING INSECT KILLER/ 04822-00284	-   SEQ CHAPTER \h \r 1
D-cis/trans allethrin (0.14%)

- 3-phenoxybenzyl d-cis and trans 2,2-dimethyl  3- (2-methylpropenyl
cyclopropanecarboxylate (0.14%)

- Piperonyl Butoxide (0.50%)	> 5000 mg/kg	43751905

PYNAMIN FORTE MOSQUITO COIL/ 10308-00017	- d-cis, trans allethrin
(0.26%)

- Other isomers (0.01%)	> 5000 mg/kg	00141405

APPENDIX E:  Aggregate Ecological Incident Reports for Allethrins.

APPENDIX F:  Data Call-In Tables.

The Environmental Fate and Effects Division (EFED) has completed a Data
Call-In (DCI) table for the allethrins ecological effects data gaps
identified in registration review. There are no environmental fate
studies with outstanding data gaps requiring a Data Call-In (DCI).  The
attached DCI tables, which include the guideline number and study title
for required data, also provide a rationale for requiring the data, an
explanation of how the data will be used, and a brief description of how
the data could impact the Agency’s future decision-making.

Effects Data:

Guideline Number:  850.3030

Study Title:  Honey Bee Toxicity of Residues on Foliage

Rationale for Requiring the Data

Under the 40 CFR Part 158 (July 1, 2009) data on honey bee toxicity of
residues on foliage are required (OPPTS 850.3030) when the acute honey
bee contact LD50 <11 µg/bee and the use pattern(s) indicate(s) that
honey bees may be exposed to the pesticide.  The acute contact LD50 for
methiocarb is 3.4 µg a.i./bee (allethrin, MRID 162751).  Therefore,
this is identified as a data gap.  Since there is no precautionary honey
bee language on allethrin product labels (at least on a subset of labels
reviewed for such language), EFED recommends requesting a honey bee
toxicity of residues on foliage study.  EFED will assume risks to
terrestrial invertebrates if honey bee toxicity of residues on foliage
data are not submitted.

Practical Utility of the Data

How will the data be used?

Honey bee toxicity of residues on foliage data will be used to reduce
uncertainties associated with assessing risks to honey bees from
allethrin exposure.  In the absence of such data, risks to honey bees
will be presumed in the risk assessment conducted for Registration
Review.

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 presume that allethrins “may
affect” listed terrestrial invertebrates directly (and listed species
from other taxa indirectly), and use of allethrins and their formulated
products may need to be restricted in areas where listed 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 allethrin use that
are unnecessarily severe.

Guideline Numbers:  850.4225 and 850.4250

Study Title:  Terrestrial Plant Toxicity Tests (Tier II)

Rationale for Requiring the Data

Terrestrial plant toxicity studies and associated risk analysis of
plants are required for registration of pesticides with outdoor uses
(CFR Part 158).  For terrestrial plants, Tier II studies (OPPTS
Guidelines 850.4225 and 850.4250) are required when potential concerns
are triggered (i.e., when there is some indication that there may be
significant toxicity to plants).  Thirteen allethrin incidents involving
plants have been reported to the Agency in aggregated incident reports
(all terrestrial plant incidents involving d-trans allethrin; PC Code:
004003; occurring from 1995 to 2005).  Therefore, the requirement for
Tier II plant studies (vegetative vigor and seedling emergence) for the
allethrins is triggered.  Unless additional information on these
aggregated incidents become available, they will be assumed to be
representative of registered uses of the allethrins in the risk
assessment.  If toxicity data for terrestrial plants are not submitted
for allethrins, EFED will assume risk for terrestrial plants in the risk
assessment.

Practical Utility of the Data

How will the data be used?

Tier II vegetative vigor and seedling emergence data for terrestrial
plants will be used to determine the potential for allethrins to affect
non-target plant species in the terrestrial environment.  In the absence
of data specific for these plants, risk to terrestrial plants will be
assumed.

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

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 PAGE

- PAGE   2  of   NUMPAGES  56 -

- PAGE   1  of   NUMPAGES  56 -

Ingestion

Birds / Amphibians

Wet/dry deposition