atmospheric transport for bifenthrin is relatively low and that this
source of the chemical is of low importance, compared to spray drift,
runoff and/ or direct contact after application.

Figure 6.1a.  Aquatic conceptual model depicting stressors, exposure
pathways, and potential effects to aquatic organisms from the use of
bifenthrin on agricultural and certain non-agricultural sites

1 Includes flow across vegetation and vegetated drainage systems (e.g.,
swales) and flow across impervious surfaces and through impervious
(piped) storm drains.

2 Immobilization is considered equivalent to mortality in toxicity tests
for aquatic invertebrates.

Dotted lines indicate exposure pathways that have a low likelihood of
contributing to ecological risk.

Figure 6.1b.  Terrestrial conceptual model depicting stressors,
exposure pathways, and potential effects to terrestrial organisms from
the use of bifenthrin on agricultural and certain non-agricultural sites

  SHAPE  \* MERGEFORMAT

Dotted lines indicate exposure pathways that have a low likelihood of
contributing to ecological risk.

The conceptual model for potential risks of bifenthrin to aquatic
organisms for various indoor uses of the chemical that could potentially
end up in a domestic wastewater “drain” is depicted in Fig. 6.2.
The stressor is the chemical of concern, bifenthrin.  It is noted that
the transport pathway is wastewater flow, the exposure media is the
treatment facility that discharges into a surface water body of water
(where it may undergo dilution), and the exposure point or route,
receptor and attribute changes for aquatic organisms are similar to the
conceptual model for agricultural applications.

Figure 6.2.  Conceptual model for potential risks of bifenthrin to
aquatic organisms for various indoor uses of the chemical that could
potentially end up in the “drain”

7.        Analysis Plan

 tc \l2 "E.        Analysis Plan

In order to address the risk hypothesis, the potential for adverse
effects on the environment is estimated.  Usage, environmental fate and
transport, and ecological effects of bifenthrin are characterized and
integrated to assess the risks.  This is accomplished using a risk
quotient (ratio of exposure concentration to effects concentration)
approach.  Although risk is often defined as the likelihood and
magnitude of adverse ecological effects, the risk quotient-based
approach does not provide a quantitative estimate of likelihood and/ or
magnitude of an adverse effect.  However, as outlined in the Overview
Document (USEPA 2004), the likelihood of effects to individual organisms
from particular uses of a chemical is estimated using the probit
dose-response slope and either the level of concern (discussed below) or
the actual calculated risk quotient value.

This analysis plan will be revisited and may be revised depending on 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 focus of this assessment is on the parent material, bifenthrin.
However, the Agency will review open literature to identify degradate(s)
of potential toxicological concern (e.g. 4’-OH-bifenthrin was observed
in certain laboratory studies, and in terrestrial field dissipation
studies).

Toxicity data for environmental mixtures of bifenthrin with other
pesticides (those mixtures occurring in the environment following
application), if available, may be presented as part of the ecological
risk assessment.  Bifenthrin may be applied in tank mixtures with other
products approved for use on registered crops.  It is expected that the
toxic effect of bifenthrin, 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 bifenthrin 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.  A discussion of
implications of the available pesticide mixture effects data on the
confidence of risk assessment conclusions will be addressed in the risk
description of the final ecological assessment.

7.2.	Measures of Exposure

In order to estimate risks of bifenthrin exposures in aquatic and
terrestrial environments, all exposure modeling and resulting risk
conclusions will be made based on maximum application rates for the
current use patterns.  Available monitoring data will also be considered
when describing potential environmental exposure to non-target
organisms.

Measures of exposure are based on aquatic and terrestrial models that
predict estimated environmental concentrations of bifenthrin using
maximum labeled application rates and methods, as well as any mitigation
measures specifically indicated on the label.  The models used to
predict aquatic EECs are the Pesticide Root Zone Model coupled with the
Exposure Analysis Model System (PRZM/EXAMS).  Also, to estimate exposure
related to releases of bifenthrin from domestic wastewater treatment
plants, the Exposure and Fate Assessment Screening Tool’s (E-FAST2)
down-the-drain module will be used.  The model used to predict
terrestrial exposure is T-REX.  The model used to derive EECs relevant
to terrestrial and wetland plants is TerrPlant.  The potential for
bioaccumulation for the chemical is assessed using the KABAM model, as
well the results from bioconcentration in fish studies (the
bioconcentration factors).  These models are parameterized using
relevant reviewed registrant-submitted environmental fate and transport
data, including information on biotransformation rates by aquatic biota.

PRZM (v.3.12.2, May 2005) and EXAMS (v.<IP_ADDRESS>, April 2005) are
screening simulation models coupled with the input shell PE5.pl (August,
2007) to generate daily exposures and 1-in-10 year EECs of bifenthrin,
that may occur from spray drift and runoff to surface water bodies
adjacent to application sites.   PRZM simulates pesticide application,
movement and transformation on an agricultural field and the resultant
pesticide loadings to a receiving water body via runoff, erosion and
spray drift.  The EXAMS model simulates the fate of the pesticide and
resulting concentrations in the water body.  The standard scenario used
for ecological pesticide assessments assumes application to a 10-hectare
agricultural field that drains into an adjacent 1-hectare water body
that is 2 meters deep (20,000 m3 volume) with no outlet.  PRZM/ EXAMS is
used to estimate screening-level exposure of aquatic organisms to
bifenthrin and/ or its transformation products, should they be of
concern.  The measure of exposure for aquatic species is the 1-in-10
year return peak or rolling mean concentration.  The 1-in-10 year peak
is used for estimating acute exposures of direct effects to aquatic
organisms. The 1-in-10-year 60-day mean is used for assessing chronic
exposure to fish and aquatic-phase amphibians. The 1-in-10-year 21-day
mean is used for assessing aquatic invertebrate chronic exposure.

Given the aquatic toxicity of bifenthrin and its likelihood to occur in
sediment, the Agency will also consider the potential exposures
resulting from benthic/ sediment concentrations (EECs).  Pore water
concentrations are commonly used to predict toxicity of non-ionic
substances in sediments and characterize exposure to organisms that
spend time in or near sediments (Di Toro et al. 1991; US EPA 2002).
PRZM/ EXAMS estimates 1-in-10-year peak and 21-day mean EECs for pore
water.

At the present time, EFED considers the use of the impervious scenario
(a PRZM modeling scenario) as the most suitable available modeling
approach for impervious runoff.  The PRZM impervious scenario may be
used in the tier 2 coupled aquatic models PRZM/EXAMS along with a
residential or other appropriate scenario such as rights-of-way (ROW) to
obtain EECs.  The conceptual model for the residential scenario
integrates simultaneous modeling of the individual use scenario with an
impervious scenario.  This approach assumes that no watershed is
completely covered by either the ¼ acre lot (the basis for the
residential scenario) or undeveloped land (the basis for the ROW
scenario) for residential and ROW use patterns; therefore, differential
amounts of runoff will occur within the watershed.  The impervious
scenario was developed to represent the paved areas within a watershed
not including roads, parking lots, sidewalks, and buildings outside the
¼ acre lot (the ¼ acre lot scenario accounts for impervious surfaces
such as buildings within the represented area).  By modeling a separate
scenario for impervious surfaces, it is also possible to estimate that
amount of exposure that could occur when the pesticide is oversprayed
onto this surface.  Using two scenarios in tandem requires
post-processing of the modeled output in order to derive a weighted EEC
that represents the contribution of both the pervious (i.e., residential
and ROW scenarios) and the impervious surfaces.  A Microsoft Excel
spreadsheet has been developed that allows for the weighting and
aggregation of exposure from both scenarios.  The daily time series from
each model run should be copied from the times series file (NAME_TS.out)
generated from the PRZM graphical user interface (PE5.pl) into the
spreadsheet provided.  The time series data are then weighted based on
percentage of impervious surface, the percentage of the pervious surface
treated, and an adjusted time series is created.  Rolling averages for
the relevant durations of exposure (e.g., 21 day and 60 day averages)
are calculated, and the relevant one-in-ten year return EEC is generated
from these distributions.

For the purposes of risk assessment it will be assumed that 1% of the
application rate could reach the impervious surfaces surrounding each
residential lot.  This amount of overspray is not based on empirical
data (no publicized studies on this occurrence have been found in the
open literature); however, the assumption is consistent with the
standard assumption of 1% spray drift with ground applications in
ecological risk assessments.  In general, incorporation of impervious
surfaces into the exposure assessment results in increasing runoff
volume in the watershed, which tends to reduce overall pesticide
exposure assuming 1% overspray to the impervious surface.  Alternative
assumptions for percent impervious surfaces, percentage of use site
treated, and percentage of overspray may be considered in order to
characterize the assumptions of the ecological risks assessment in the
context of the individual exposure assessment and risk conclusions.  For
example, previously tested assumptions used in the endangered species
assessments may be considered for characterization (i.e., 10% and 30%
impervious surfaces, 10% lot treated, and 0% and 10% overspray) unless
other relevant values can be determined (i.e., modeling may be completed
for the impervious surface with 0% and 10% overspray to provide lower
and upper bound values).  The results of these alternate modeling
exercises may be discussed in the assessment.

In addition, the impervious surface scenario can be used for other
purposes, such as use sites for which no other scenario exists and the
use is assumed to be represented by an impervious surface.

The Division acknowledges that washoff from impervious surfaces could be
sources of pyrethroids.  Nonetheless, at the present time, the EFED does
not anticipate requiring washoff studies.  These previously described,
and other subsequently published studies will be taken into
consideration at the time of the final environmental risk assessment.
Furthermore, EFED will consider a pathway identification study being
proposed by the Pyrethroids Working Group (PWG), which will be conducted
per CDPR requirements and of which a draft protocol dated 9/17/2010 was
received.

The Agency has limited use and usage information relevant to urban
exposures and residential uses of pyrethroids, including bifenthrin.
The Agency intends to use available non-agricultural use and usage data,
such as the Kline database, the California Department of Pesticide
Regulation’s (CDPR) Pesticide Use Reporting Data and Pest Control
Operator’s usage survey, and the Residential Joint Venture Task Force
homeowner survey data (2003), to make certain reasonable assumptions
regarding various applications and information related to
urban/residential use.  Due to the limited data available, exposure to
the environment and uncertainties will be characterized.  Detailed
information on non-agricultural use and usage of pyrethroid products,
specifically bifenthrin, would be useful in order to reduce those
uncertainties for the final environmental risk assessment for
bifenthrin.

To estimate exposure related to releases of bifenthrin to domestic
wastewater treatment, the Agency will rely on the Office of Pollution
Prevention and Toxics (OPPT) model, Exposure and Fate Assessment
Screening Tool (E-FAST, version 2.0, 2007, or EFAST2). From this model,
the Agency used the “Down-the-Drain” module, which is designed for
releases to domestic wastewater treatment. It is suitable for all the
sources of bifenthrin that could potentially be exposed through a
“down-the-drain” scenario. The model provides screening level
estimate concentrations of chemicals in surface water that may result
from household uses and the disposal of consumer products into
wastewater using a few simple input parameters (production volume and
fraction of the chemical removed during wastewater treatment).  The
exposure model available to the Division for wastewater exposures is for
indoor uses only (i.e., “down-the-drain”).  The Agency does not
contemplate to consider exposures due to combined sewer system overflow
at this time.  The non-crop outdoor uses described by the combination of
the impervious and residential or ROW PRZM scenarios run in tandem, as
described above, presumably provide high end estimated exposure
environmental concentrations (EECs).  They describe applications to
pervious and impervious surfaces and the direct exposure to the EXAMS
modeling pond; thus, they are more conservative than exposures due to
combined sewer overflows.

The Agency is actively evaluating the extent to which ecological risk
from bifenthrin via land application of biosolids should be addressed in
its forthcoming environmental fate and ecological risk assessment, and
by extension, any additional data that may be required.  As part of this
evaluation, OPP is working closely with the Office of Water which
regulates land application of biosolids under the Clean Water Act.

The Agency has also been made aware of the presence of bifenthrin in
compost [email communication from D. Alder, of the California Department
of Pesticide Regulation (CDPR), to Jacqueline Guerry on 01/12/2010].
Compost containing turf from golf courses or urban residences that may
be used by organic growers has been found to contain detectable levels
of bifenthrin.  According to the communication, “CDPR has requested a
scoping document from CalRecycle to document further define the problem
that includes:

1.	The percentage of green waste being received by composters from golf
courses and urban residences.

2.	Documented concentrations of bifenthrin in green waste as reported by
composters, organic-certifying organizations, and/or the California
Department of Food and Agriculture.

3.	Identification of its significant adverse effects.”

The Agency will continue to work with the CDPR, and be aware of this
issue.  This issue is just developing.  Should it be required, the issue
will be discussed either qualitatively or quantitatively in the risk
assessment.

Exposure estimates for terrestrial animals assumed to be in the target
area are derived using the T-REX model (version 1.3.1, 12/07/2006).
This spreadsheet-based model calculates the residues on avian and
mammalian food items along with the dissipation rate of a chemical
applied to foliar surfaces (for single or multiple applications) in
order to estimate acute and reproductive risk quotients.  T-REX
calculates EECs and risk quotients based on both the upper bound and
mean residue concentrations as presented by Hoerger and Kenaga (1972)
and modified by Fletcher et al. (1994). These concentrations are
determined using nomograms that relate application rate of a pesticide
to residues remaining on dietary items of terrestrial organisms.  For
pesticides such as bifenthrin, which can be applied as a dust, this
includes the amount of pesticide per square foot, used in LD50 per
square foot risk assessment calculations.

  SEQ CHAPTER \h \r 1 EECs for terrestrial plants inhabiting dry and
wetland areas are derived using TerrPlant (version 1.2.2, 12/26/2006).
This model uses estimates of pesticides in runoff and in spray drift
(assumed to be 0% for granulars) to calculate EECs.  EECs are based upon
solubility, application rate and minimum incorporation depth.

As indicated in Table 3.1 and its associated text in Section 3,
bifenthrin appears to have a potential to bioaccumulate in aquatic
organisms and biomagnify in terrestrial organisms.  The potential for
bioaccumulation of bifenthrin will also be examined in the risk
assessment.  The bioconcentration factors ranged from 2110 (edible) to
8720 (non-edible) and depuration rate is slow (43-53% of the residues
still remaining in the fish after 42 days of depuration, Acc. No.
264642, MRID 163094, 163095).  Bioaccumulation will be assessed using
the results from bioaccumulation in fish studies, as well as the KABAM
model (KOW (based) Aquatic BioAccumulation Model, version 1.0, 2009),
adjusting for biotransformation rates.  KABAM is used to estimate
potential bioaccumulation of hydrophobic organic pesticides in
freshwater aquatic ecosystems and risks to mammals and birds consuming
aquatic organisms which have bioaccumulated these pesticides.

7.3.	Measures of Effect

Ecological effects data are used as measures of direct and indirect
effects to biological receptors.  Data are typically 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 (freshwater and saltwater), 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.

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 NOAEC.  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.

Information on the potential effects of bifenthrin on non-target animals
is also collected from the Ecological Incident Information System
(EIIS).  The EIIS is a database containing adverse effect (typically
mortality) reports on non-target organisms where such effects have been
associated with the use of pesticides.  Information on incidents
involving avian species is also provided through the Avian Monitoring
Information System (AIMS), which is maintained by the American Bird
Conservancy.

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.

In absence of data on terrestrial-phase amphibians and reptiles, t  SEQ
CHAPTER \h \r 1 he assessment of risk from direct effects to non-target
organisms makes the assumption that the toxicity of bifenthrin to birds
is similar to terrestrial-phase amphibians and reptiles.  The same
assumption is made for fish and aquatic-phase amphibians in the absence
of aquatic-phase amphibian data.

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 pesticides and the likelihood of direct and indirect effects
to non-target organisms in aquatic and terrestrial habitats.  The
exposure and toxicity effects data are integrated in order to evaluate
the risks of adverse ecological effects on non-target species.  For the
assessment of risks, the risk quotient (RQ) method is used to compare
exposure and measured toxicity values.  EECs are divided by acute and
chronic toxicity values.  The resulting RQs are then compared to the
Agency’s Levels of Concern (LOCs) (USEPA 2004).  These criteria will
be used to indicate when bifenthrin’s uses, as directed on the label,
have the potential to cause adverse direct or indirect effects to
non-target organisms.  In addition, incident data from the EIIS will be
considered as part of the risk characterization.

7.5.	Deterministic and Probabilistic Assessment Methods

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

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
bifenthrin.  This 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 bifenthrin
is based on an action area.  The action area is considered to be the
area directly or indirectly affected by the federal action, as indicated
by the exceedance of Agency Levels of Concern (LOCs) used to evaluate
direct or indirect effects.  The Agency’s approach to defining the
action area under the provisions of the Overview Document (USEPA 2004)
considers the results of the risk assessment process to establish
boundaries for that action area with the understanding that exposures
below the Agency’s defined LOCs constitute a no-effect threshold.
For the purposes of this assessment, attention will be focused on the
footprint of the action (i.e., the area where bifenthrin application
occurs), plus all areas where offsite transport may result in potential
exposure that exceeds the Agency’s LOCs.  Specific measures of
ecological effect that define the action area for listed species include
any direct and indirect effects and/ or potential modification of its
critical habitat, including reduction in survival, growth, and
reproduction as well as the full suite of sub-lethal effects available
in the effects literature.  Therefore, the action area extends to a
point where environmental exposures are below any measured lethal or
sub-lethal effect threshold for any biological entity at the whole
organism, organ, tissue, and/ or cellular level of organization.  In
situations where it is not possible to determine the threshold for an
observed effect, the action area is not spatially limited and is assumed
to be the entire United States.

Probit Analysis

Analysis of raw data from the aquatic acute toxicity studies for
bifenthrin estimate slopes of 3.5 (95% C.I. 2.08 and 4.99) for
freshwater fish, 1.69 (95% C.I. 1.35 and 2.03) for freshwater
invertebrates, and a 4.5 default slope for estuarine/marine fish and for
estuarine/marine invertebrates. Based on these slopes, the corresponding
estimate chance of individual mortality following bifenthrin exposure is
1 in 3.79 x 105 for freshwater fish, 1 in 7.17 x 101 for freshwater
invertebrates, and 1 in 4.18 x 108 for estuarine/marine fish and
invertebrates.

To explore possible bounds to such estimates, the upper and lower values
for the mean slope estimate can be used to calculate upper and lower
estimates of the effects probability associated with the listed species
LOC. These values are 1 in 2.94 x 102 to 1 in 2.36x1010 for freshwater
fish and 1 in 2.53 x 101 to 1 in 2.42 x 102 for freshwater
invertebrates.

Currently, EFED does not assess risk to non-target insects.  Results of
acceptable studies are used for recommending appropriate label
precautions.  Based on the results of a single study in honey bees (LD50
of 0.015 μg a.i./bee), bifenthrin is classified as highly toxic on an
acute contact basis. This study suggests that the acute toxicity to
non-target beneficial endangered insects may also be of concern should
exposure actually occur.

  SEQ CHAPTER \h \r 1 Toxicity data are not available for terrestrial
and semi-aquatic plants; thus, risks associated with bifenthrin exposure
to terrestrial plants cannot be assessed.  Furthermore, a review of
bifenthrin’s mode of action (neural toxin) suggests that direct
toxicity to plants should not be an issue of concern.  However, these
studies are required under the new guidelines.

7.7.	Drinking Water Assessment

A drinking water assessment will be conducted to support future human
health risk assessments of bifenthrin should it be required. The
drinking water assessment will incorporate model estimates of bifenthrin
in surface and ground waters.  Concentrations in surface waters will be
estimated using FQPA Index Reservoir Screening Tool (FIRST, v.1.1.1,
12/18/07) (or subsequently using PRZM/ EXAMS, with the Index Reservoir -
see description above, if refinements are required).  Ground water
estimates of concentrations will be estimated using the Screening
Concentration in Ground Water (SCI-GROW) model (v.2.3, July 2003).  The
drinking water assessment will also include a summary of available
surface and ground water monitoring data.

7.8.	Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine
Disruptor Screening Program (EDSP) to determine whether certain
substances (including pesticide active and other ingredients) may have
an effect in humans or wildlife similar to an effect produced by a
“naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.”  The EDSP employs a two-tiered approach
to making the statutorily required determinations. Tier 1 consists of a
battery of 11 screening assays to identify the potential of a chemical
substance to interact with the estrogen, androgen, and or thyroid (E, A,
or T) hormonal systems. Chemicals that go through Tier 1 screening and
are found to have the potential to interact with E, A, or T hormonal
systems will proceed to the next stage of the EDSP where EPA will
determine which, if any, of the Tier 2 tests are necessary based on the
available data. Tier 2 testing is designed to identify any adverse
endocrine related effects caused by the substance, and establish a
dose-response relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data
call-ins for the first group of 67 chemicals, which contains 58
pesticide active ingredients and 9 inert ingredients.  This list of
chemicals was selected based on the potential for human exposure through
pathways such as food and water, residential activity, and certain
post-application agricultural scenarios.  This list should not be
construed as a list of known or likely endocrine disruptors.

Bifenthrin is among the group of 58 pesticide active ingredients on the
initial list to be screened under the EDSP. The Agency will review the
EDSP Tier 1 data and any “other scientifically relevant information”
submitted in response to test orders.  Based on this review the Agency
will determine the need for additional testing.  For further information
on the status of the EDSP, the policies and procedures, the list of 67
chemicals, the test guidelines and the Tier 1 screening battery, please
refer to the following website:    HYPERLINK "http://www.epa.gov/endo/"
http://www.epa.gov/endo/  .

7.9.	Preliminary Identification of Data Gaps

The California Department of Pesticide Regulation (CDPR) placed
bifenthrin and other synthetic pyrethroids into reevaluation in 2006.
Certain data requirements were imposed to those pyrethroids.  EPA is
already in communication with CDPR and their data should also be
submitted to the Agency.  More information on the CDPR reevaluation
program for pyrethroids at   HYPERLINK
"http://www.cdpr.ca.gov/docs/registration/reevaluation/chemicals/pyrethr
oids.htm"
http://www.cdpr.ca.gov/docs/registration/reevaluation/chemicals/pyrethro
ids.htm  .

7.9.1.	Fate

After evaluation of the available data for bifenthrin, the following are
the data gaps for registration review:

835.2120 Hydrolysis – The available study was performed in the
presence of high levels of cosolvent acetonitrile (around 7%; maximum
allowed 1% v/v) and at high concentrations (0.5 and 5.2 ppm vs. the
solubility of bifenthrin is 0.014 ppb; thus the test was performed at
>35,000X the solubility limit of bifenthrin).  There was evidence of
precipitation during the test.  According to the authors, bifenthrin was
stable to hydrolysis at a pH range of 5 to 9.  It is unknown if the
presence of the cosolvent, or the extremely high concentrations could
have affected or confounded the study results. According to the OPPTS
835.2120 guideline, “In case a higher concentration of solvents is
considered (e.g., in the case of poorly soluble test substances), this
could only be allowed when it can be shown that the solvent has no
effect on the hydrolysis of the test substances.”  The registrant
should address the Agency’s concern, or a new study is required.

835.2240 Aqueous Photolysis – The available study was performed in the
presence of high levels of cosolvent acetonitrile (around 30%).  Also,
the samples were not buffered and the studies were performed at above
the solubility limit (at 1 ppm vs. the solubility of 0.014 ppb).  The
study indicates that bifenthrin was stable to aqueous photolysis in
natural sunlight.  It is unknown if the presence of the cosolvent could
have affected the study results.  In the same study, using artificial
light, bifenthrin degraded with a reported half-life of 11.9 days and in
sensitized (acetone) solution it was 0.31 days.  There is a high level
of uncertainty with respect to the levels of photolysis.  A new study is
required.  The EFED may waive the requirement of a cosolvent
concentration of ≤1% by volume provided that the registrant submits
the following:

The UV/Vis spectrum for bifenthrin in buffered solution (preferred at pH
5): this will allow the Agency to determine bifenthrin’s potential for
aqueous photolysis.

Information confirming that efforts have been made to improve the
analytical methods for the parent and possible transformation products.

Evidence that acetonitrile (or the cosolvent chosen) does not sensitize
bifenthrin, causing the rate of photolysis to increase.

Proof that the lowest feasible concentration of the cosolvent was used.

835.4100 Aerobic Soil Metabolism – A study performed in one soil
should be submitted.  At this time the Agency has studies performed in
three soils; however, the studies lasted 120 days for the alcohol label
and 180 days for the cyclopropyl label.  According to test OPPTS
Guideline 835.4100 & 835.4200, studies are required in a total of four
soils.  The registrant should monitor the volatiles, which were not
monitored in the previous studies, and there is uncertainty about their
relevance.

835.4200 Anaerobic Soil Metabolism – The available study was performed
with only one soil and for a period of roughly 2 months of anaerobic
incubation.  Anaerobic studies with one soil type are generally
sufficient for the evaluation of transformation pathways. Rates of
transformation should be determined in at least three additional soils
(from Fate, Transport and Transformation Test Guidelines – OPPTS
Guideline 835.4100 & 835.4200).  The study indicates that after the soil
was flooded (converted to anaerobic), the metabolism was very low.  Data
performed for a longer period of time will help the Agency to determine
rates of transformation and presence of possible metabolites.  The
registrant should monitor closely the volatiles, for which there is
uncertainty about their relevance.

835.4300 Aerobic Aquatic Metabolism – No study has been submitted.
The study is required.  The registrant should monitor the volatiles, for
which there is uncertainty about their relevance.

835.4400 Anaerobic Aquatic Metabolism – No study has been submitted.
The study is required.  The registrant should monitor the volatiles, for
which there is uncertainty about their relevance.

 ≥ 100,000; FAO Mobility Classification).  A new study is required.

Environmental Chemistry Methods (ECMs), and Independent Laboratory
Validations (ILVs), for Soil, Water and Sediment.  ECMs associated with
the Terrestrial Field Dissipation study (Field dissipation §158.1300;
OPPTS guidelines 835.6100, 835.6200, and 835.6300), along with
successful confirmatory method trials (validation) by an independent
laboratory (i.e. ILVs), are required.  If there is risk concern for a
given taxon, ECMs should be available for the environmental media in
which organisms of the taxon reside.  These ECMs should have limits of
quantization for the residues of concern that are lower than the
relevant toxicological levels of concern.  Previous reviews on
bifenthrin indicate that there is high concern for acute and chronic
aquatic toxicity.  Certain scenarios may have triggered acute and
chronic levels of concern for freshwater and/ or estuarine/ marine
aquatic invertebrates and/ or for fish.  In addition, the latter risk
assessments conducted on bifenthrin, indicated risk concerns for
organisms living in the benthos.  Therefore, ECMs for water and sediment
are required in addition to the ECM for soil.  The ECMs should include
parent and those residues found in the laboratory studies that exceeded
10% of the applied.  Based on the available data at this time, the
following appear to be the residues of concern for each media, but this
could change, based upon the results of the other environmental fate
studies.

Soil, Water and Sediment – parent only:

The registrant is encouraged to submit state-of-the-art environmental
chemistry methods; further, multi-residue methods (MRMs) for soil, water
and sediment are preferred, if applicable.  The registrant submitted one
method for soil (MRID 41673103, LOQ and LOD unknown, published in the
Agency’s ECM website) is available, that could quantify bifenthrin and
its metabolite 4’-hydroxy-bifenthrin (4’-OH-bifenthrin) in soil; the
standard solutions were at 0.1 ng/µL and the fortified soil control
samples had 0.05 – 0.1 ppm of each analyte.  These levels of
quantization may not be appropriate.  Also, the studies MRID 47053001
and 47053002 will be evaluated for its suitability.  A full description
of the method validation procedures performed by an independent
laboratory should also be submitted.  It should include the following
information (Corbin et al. 2006): (a) Recovery level(s) of the test
compound(s) from the soil, water and sediment (substrates) at various
relevant fortification level(s) using the residue analytical
methodology; (b) a validated method sensitivity level; (c) results of
the study and statistical test applied, including a stepwise
presentation of the procedure for calculating percent recovery from the
raw data; (d) all the data/ information necessary to independently
verify the results; (e) summary of the results; and, (f) discussion and
conclusions of the results.

Other data needs:

Leachability from Treated Wood – A study was required in a previous
review document (D290992, 03/09/05) and two studies were submitted
(MRIDs 47454101 and 47454102).  One study was conducted based on the
American Wood Preservers Association Standard Method of Determining the
Leachability of Wood Preservatives (E11-97) and the other was conducted
according to an OECD proposed guideline Estimation of Emissions from
Preservative – Treated Wood to the Environment (currently assigned
guideline number 313).  These studies are currently in review.  This
data requirement is considered unfulfilled until the studies are
reviewed and deemed acceptable.

POTW Effluent Monitoring – Request any existing or ongoing POTW
effluent monitoring data for the pyrethroids be submitted to the Agency.

POTW Treatability Study – The Agency has recently requested and
provided comments on a protocol developed by the Pyrethroid Working
Group (PWG) for a bench scale study of waste water treatment, to assess
the percentage removed in the biosolids by the treatment, the amount
that would degrade during treatment, and the amount that would remain in
the waste water.   These data would be used to inform removal
percentages by waste water treatment, which is an input to the Exposure
and Fate Assessment Screening Tool’s (E-FAST) down-the-drain module.
The Office of Pesticide Programs will continue to confer with the Office
of Water with the goal of refining our down-the-drain assessment for
registration review.  It is the responsibility of the registrant to
ensure that bifenthrin is included in the study completed by the PWG or
conduct a similar study on their own (following submission of a protocol
for review).

The Agency received comments from stakeholders with concerns regarding
the value of a POTW Treatability Study and its representativeness of
numerous treatment plant designs.  EFED recognizes that such differences
in plant design and operation may affect removal efficiencies, which is
why it is proposing to require a POTW treatability study for bifenthrin,
to support its EFAST2 down-the-drain modeling.  EFED is currently
working with the registrant on the design of this study to best meet the
Agency’s environmental risk assessment needs.  Part of the design of
this study will need to address factors that the commenters present
(i.e., the effect of differences in POTW design and operation on removal
efficiencies) to the extent practicable.  This may involve differences
in experimental conditions and/ or the use of POTW simulation models to
address these concerns.  The ability to extrapolate the bench scale
results to results from available POTW monitoring data will also be
evaluated.  The forthcoming environmental risk assessment would address
the uncertainty involved in the interpretation and extrapolation of
results from the POTW treatability study to the national scale.

The Agency is actively evaluating the extent to which ecological risk
from bifenthrin via land application of biosolids should be addressed in
its forthcoming environmental fate and ecological risk assessment, and
by extension, any additional data that may be required.  As part of this
evaluation, OPP is working closely with the Office of Water which
regulates land application of biosolids under the Clean Water Act.

EFED is unaware of any studies that suggest inhibition of POTW treatment
processes is a significant risk due to documented pyrethroid exposures.
Furthermore, EFED considers effects on POTW treatment processes to be
beyond the scope of its environmental risk assessments.

Table 7.1 lists the status of the environmental fate data requirements
for bifenthrin.

Table 7.1. Summary of Environmental Fate Data Requirements for
Bifenthrin  SEQ CHAPTER \h \r 1

Study Identification

Use

Pattern1	Does EPA Have

Data To Satisfy

This Requirement?	Bibliographic Citation	Must Additional Data Be
Submitted Under FIFRA 3(c)(2)(B)?

§158.1300 ENVIRONMENTAL FATE

Degradation Studies-Lab:

835.2120  Hydrolysis	1,2	Yes	251728 (132539)	Yes2

835.2240  Photodegradation in Water	1,2	Yes

264642 (163084)	Yes2

835.2410  Photodegradation on Soil	1,2	Yes

ACC: 264642 or MRID 163085	No

835.2370  Photodegradation in Air	1,2	No	Not Available	Reserved3

Metabolism Studies-Lab:

835.4100  Aerobic Soil	1,2	Yes

073174, 073225, 141502, 251278, 251728, 254401, 254411, 532540	Yes4

835.4200  Anaerobic Soil	1,2	Yes

Acc. No. 264642 or MRID 163088	Yes

835.4400  Anaerobic Aquatic	1,2	No	Not Available	Yes

835.4300  Aerobic Aquatic	1,2	No	Not Available	Yes

Mobility Studies:

835.1230  Leaching – Adsorption/ Desorption	1,2	Yes

251728, 254411	Yes

835.1410  Volatility (Lab)	1,2	Yes

41220601	No

835.8100  Volatility (Field)	1,2	No	Not Available	Reserved3

Dissipation Studies-Field:

835.6100  Terrestrial Field Dissipation	1,2	Yes

264642, 42339203, 42339201, 42334167, 41673103, 41676101, 41671302	No

835.6200  Aquatic Field Dissipation	1,2	Yes	40981803, 40981805,
40981808, 40981812, 40981814, 40981815, 40981816, 40981817, 40981818,
40981819	No

835.6300   Forestry Dissipation	1,2	No	Not Applicable	N/A

Ground Water Monitoring Studies:

835.7100  Ground Water Monitoring	1,2	No	NA	Reserved

§158.1100  SPRAY DRIFT

201-1  Droplet Size Spectrum	1,2	No	Not Available	No5

202-1  Drift Field Evaluation	1,2	No	Not Available	No5

Other Studies:

Environmental Chemistry Methods (ECMs) and Independent Laboratory
Validations (ILVs)	1,2	Partially	41673103,

47053001, 47053002	Reserved6

Leachability from Treated Wood	1.2	Yes	47454101, 47454102	Reserved6

1.  Use Patterns: 1=Terrestrial/Food; 2=Terrestrial/Feed.

2.  The studies were conducted in the presence of acetonitrile and other
problems were observed.  New studies are required.

3.  Reserved pending evaluation of the results of the volatiles from all
the laboratory metabolism studies.

4.  One study is required, conducted in one soil; the registrant should
monitor the volatiles in this study, since this was not done in any of
the available studies and there is uncertainty as to their relevance.

5.  Data requirement covered by submission of the Spray Drift Task
Force.

6.  Reserved pending evaluation of two available studies.

7.9.2	Effects

For registration review, the following studies are being requested to
fulfill any data gaps:

Bifenthrin is part of the Endocrine Disruptor Screening Program; certain
data has been required for the chemical under the program (DCI on
11/19/09; 90-day response by 02/27/10).  Please, refer to the website:
HYPERLINK "http://www.epa.gov/endo/"  http://www.epa.gov/endo/ .

Study Title:  Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine
Disruptor Screening Program (EDSP) to determine whether certain
substances (including pesticide active and other ingredients) may have
an effect in humans or wildlife similar to an effect produced by a
“naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.”  The EDSP employs a two-tiered approach
to making the statutorily required determinations. Tier 1 consists of a
battery of 11 screening assays to identify the potential of a chemical
substance to interact with the estrogen, androgen, and or thyroid (E, A,
or T) hormonal systems. Chemicals that go through Tier 1 screening and
are found to have the potential to interact with E, A, or T hormonal
systems will proceed to the next stage of the EDSP where EPA will
determine which, if any, of the Tier 2 tests are necessary based on the
available data. Tier 2 testing is designed to identify any adverse
endocrine related effects caused by the substance, and establish a
dose-response relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data
call-ins for the first group of 67 chemicals, which contains 58
pesticide active ingredients and 9 inert ingredients.  This list of
chemicals was selected based on the potential for human exposure through
pathways such as food and water, residential activity, and certain
post-application agricultural scenarios.  This list should not be
construed as a list of known or likely endocrine disruptors.

Bifenthrin is among the group of 58 pesticide active ingredients on the
initial list to be screened under the EDSP. The Agency will review the
EDSP Tier 1 data and any “other scientifically relevant information”
submitted in response to test orders.  Based on this review the Agency
will determine the need for additional testing.  For further information
on the status of the EDSP, the policies and procedures, the list of 67
chemicals, the test guidelines and the Tier 1 screening battery, please
visit our website:    HYPERLINK "http://www.epa.gov/endo/"
http://www.epa.gov/endo/  .

Guideline Number: 850-2100

Study Title:  Passerine Acute Avian Oral

Although an acute avian oral study was received for both the Mallard
duck and Bobwhite quail, the Agency updated its data requirements in 40
CFR Part 158 (October 26, 2007) to include an acute oral toxicity study
for both a passerine species and either a waterfowl or an upland game
species.  Prior to starting toxicity testing, a protocol will need to be
provided for review. Many passerine species utilize agricultural fields,
forests, residential areas and surrounding areas, and, therefore, have
the potential to be exposed to pesticides used in agricultural, forest,
and residential settings. It is likely that, for most pesticide use
patterns, passerines are more likely to be exposed to pesticides than
upland game species and waterfowl. Passerines are smaller in size and
generally have faster metabolisms than the waterfowl and upland game
bird species traditionally used in avian toxicity tests which could
impact their sensitivity to chemicals.

Guideline Number: 850-1400

Study Title: Fish Early Life Stage (Saltwater)

No acceptable chronic studies for bifenthrin have been submitted for
marine fish . The acute toxicity of bifenthrin to estuarine/marine fish
and environmental fate properties indicate the potential for chronic
exposure and effects to animals in this taxon, per 40 CFR Part 158 data
requirements (October 26, 2007). For example, the acute LC50 for
freshwater fish (0.15 μg ai/L) is well below the 1.0 mg/L criterion
specified in 40 CFR Part 158 for conditionally requiring this study.
Furthermore, the persistence of bifenthrin in water is expected to
substantially exceed the 4-d half life criterion.  Without this study,
the Agency would have to presume chronic risk to listed and non-listed
estuarine/marine fish, but would not be able to quantify the risk.

Guideline Number: 850-1500

Study Title: Fish Full Life Cycle

The need for a full life cycle chronic toxicity test of bifenthrin to
fish is indicated based on its aquatic toxicity and environmental fate
properties per 40 CFR Part 158 data requirements (October 26, 2007).
Specifically, a fish full life cycle study may be conditionally required
when the end use product is expected transported to water from its
intended use site, and if any of the following apply:

1. The EEC is > 0.1 the NOEC from the fish ELS or invertebrate LC test,
or

2. Studies of other organisms indicate reproductive physiology in fish
may be affected.

For bifenthrin, 60-d EECs in surface water range from 0.017 to 0.10
µg/L based on a recent assessment of new uses on mayhew, soybean and
other crops (D336608; Meléndez and Federoff, 2007).  These EECs clearly
exceed 0.004 µg/L, which is one tenth of the fathead minnow ELS NOAEC
(i.e., 0.004 = 0.1 * 0.04 µg/L MRID 40791301) and the freshwater
invertebrate LC NOAEC (0.0013 µg/L; MRID 41156501).  Furthermore,
adverse effects were observed on Daphnia magna reproduction at 0.003
ug/L, which may indicate that similar reproductive effects are likely to
occur in fish.

Although a fish full life cycle study was previously submitted to the
Agency and classified as supplemental (MRID 40791301), a recent review
of this study revealed that it is unacceptable based on numerous
deficiencies identified in the study, such as low control survival and
an inadequate number of replicates (D381123; October 14, 2010).
Therefore, a new fish full life cycle study is required.  Should the
registrant choose to conduct the study on an estuarine/marine fish, then
the additional requirement for an ELS study with estuarine/marine fish
could be satisfied with just one study.

Guideline Number: 850-1350

Study Title: Aquatic Invertebrate Life Cycle (Estuarine/marine)

The need for a life cycle chronic toxicity of bifenthrin to
estuarine/marine invertebrates is indicated based on its aquatic
toxicity and environmental fate properties per 40 CFR Part 158 data
requirements (October 26, 2007).   The preferred test species is
Americamysis bahia. Specifically, bifenthrin is intended for use such
that its presence in estuarine/marine environment in significant
concentrations is expected.  In addition, the acute LC/EC50 for
bifenthrin (e.g., 1.6 µg/L for Daphnia magna, is substantially lower
than the 40 Part 158 trigger value of 1 mg/L.  Previous risk assessments
have indicated that the aquatic EECs are > 0.01 of the acute LC/EC50
values for bifenthrin, which is another condition for triggering an
estuarine/marine invertebrate life cycle study.  Finally, it is noted
that the acute toxicity of estuarine/marine invertebrates (LC50 of 0.004
µg/L) is nearly three orders of magnitude lower than that for
freshwater invertebrates (EC50 of 1.6 µg/L).  This comparison suggests
that estuarine/marine invertebrates may be particularly sensitive to
bifenthrin.  Information on the chronic toxicity of bifenthrin to
estuarine/marine invertebrates is therefore needed.

Non-Guideline Study

Study Title:  Whole sediment: chronic invertebrates freshwater and
marine

For bifenthrin, available information indicates that benthic organisms
may be exposed via run-off or spray drift applications used in
agricultural, forest, and residential settings. Specifically, the peak
sediment porewater EECs predicted for bifenthrin (0.006 – 0.014 ppb,
for a variety of crops) exceed 0.1 of the acute LC/EC50 (0.004 ppb for
M. bahia), which satisfies one of the criteria for requiring chronic
whole sediment toxicity testing under 40 CFR Part 158.  Further, the
expected half-life of bifenthrin in sediment (observed to be relatively
stable in anaerobic soil metabolism study, and 251-498 days for
anaerobic aquatic metabolism, Gan et al. 2005) is substantially greater
than 40 CFR Part 158 criterion of 10 days.  The third set of trigger
criteria for requiring chronic testing (Kd > 50, or log KOW > 3 or KOC >
1000) is also met for bifenthrin (e.g., Kd values are 992-5430, log KOW
is 6.4, and KOC values are 131,000-275,000).  Finally, the potential for
persistent exposure from bifenthrin in sediment is also indicated by
open literature studies on pyrethroids (Weston et al. 2005, Amweg et al.
2006 and Ding et al. 2010).

As noted previously, acute and chronic sediment toxicity tests for
freshwater or marine invertebrates have been submitted (MRIDs 465915-02
& -01, respectively) in response to a previous SAP on pyrethroid
sediment toxicity testing.  However, the 28-d chronic whole sediment
toxicity test with L. plumulosus did not include measurement of
reproductive endpoints. and does not satisfy the chronic whole sediment
testing requirements for estuarine/marine invertebrates.

For sediment, studies involving pyrethroids, tests on Hyalella azteca,
Chironomus dilutus, and Leptocheirus plumulosus are requested.  Although
both are freshwater species, Hyalella and Chironomus differ
substantially in their ecological niche (i.e., epibenthic vs. infaunal
species).  Furthermore, Hyalella and Chironomus differ significantly in
their physiology and life history, with Chironomus being the only
sediment test species undergoing metamorphosis and emergence from an
aquatic to a terrestrial life stage.  There is also evidence suggesting
Hyalella is among the more sensitive invertebrates to some pyrethroids
based on water column tests (Anderson et al. 2006, Maund et al., 2002).
Bifenthrin has the potential to enter estuarine/marine water bodies
based on current usuage patterns that include coastal areas. Therefore,
testing is required for Leptocheirus plumulosus, an estuarine/marine
sediment-dwelling invertebrate species.

The Agency has received a chronic whole sediment toxicity test with L.
plumulosus for bifenthrin (MRID 465915-01). This study is currently
under review.  However, it is noted that the 28-d test with L.
plumulosus only included survival and growth endpoints (with no
reproduction data were provided).  Therefore, this test will not satisfy
the Agency’s chronic whole sediment toxicity test requirement for
estuarine/marine invertebrates due to the lack of data on reproduction.

Guideline Numbers: (OPPTS 850.1010)

Study Title: Aquatic Invertebrate Acute Toxicity (Hyalella azteca)

Available information indicates that the freshwater amphipod, Hyalella
azteca, is substantially more sensitive to pyrethroids than Daphnia
magna, the commonly tested freshwater invertebrate (e.g., Anderson et
al. 2006; Maund et al., 2002).  Information on the acute toxicity of
bifenthrin to H. azteca was not identified in this problem formulation.
Therefore, in order to ensure that risk to sensitive aquatic
invertebrates are appropriately quantified, additional acute toxicity
testing of H. azteca is needed (water column exposure, not
sediment-spiked).

Guideline Numbers: (OPPTS 850.1035)

Study Title:  TEP Toxicity testing with Aquatic Organisms

Testing on Typical end-use products (TEP)

According to the Part 158 data requirements, testing on the typical
end-use product may be required for aquatic toxicity tests when any of
the following conditions exist:

	1.  The end-use product will be introduced directly into the aquatic
environment.

2.  The maximum expected environmental concentration or estimated
environmental concentration in the aquatic environment is greater than
or equal to one-half the LC50 or EC50 of the TGAI.

3.  An ingredient in the end-use formulation other than the active
ingredient is expected to enhance the toxicity of the active ingredient
or cause toxicity to aquatic organisms.

Previous assessments indicated that the expected environmental
concentrations of bifenthrin in aquatic environments were based on the
solubility limit in water (0.014 ppb). In freshwater and
estuarine/marine tests conducted with bifenthrin technical, the most
toxic 96-hour LC50s were 0.15 ug/L for rainbow trout, 1.6 ug/L for
Daphnia, 17.5 µg/L for sheepshead minnow and 0.004 µg/L for mysid
shrimp. Therefore, bifenthrin fulfills the second requirement for TEP
testing for estuarine/marine invertebrate species only.

A Typical End-Use Product is defined in the Pesticide Assessment
Guidelines Subdivision J Hazard Evaluation:  Nontarget plants on Part
120-2(1) on Page 18 as “a pesticide product that is representative of
a major formulation category (e.g., emulsifiable concentrate, granular
product, wettable powder) and pesticide group (e.g., herbicide,
fungicide, insecticide etc.) and contains the active ingredient of the
applicant’s product.” (Holst and Ellwanger, 1982)

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

“The Agency seeks to avoid imposing a burden of duplicative testing on
applicants for registration.  Therefore, where 40 CFR Part 158 specifies
that the test substance should be a representative end-use product,
testing may be performed using the formulation in question (end-use
product being registered) or similar, yet representative, end-use
product.  It is not necessary to repeat the test using other similar
products.” (Holst and Ellwanger, 1982).

When TEP data are requested, data should be submitted for the different
formulations, e.g., wettable powder, emulsifiable concentrate, granular,
along with a rationale as to why the TEP is representative of other
similar end-use products. Acute aquatic toxicity studies conducted with
the Typical End-Use Product (TEP) may be used to assess effects as a
result of exposure to spray drift only and reflect potential effects
from a brief exposure to the formulation. Therefore, appropriate TEPs
should be selected from formulations that are registered for
agricultural uses, not residential.

Guideline Numbers: 850.4150 and 850.4250

Study Title: Vegetative vigor and Seedling emergence, Tier I/II

No acceptable toxicity data are currently available to assess the risk
of bifenthrin to non-target terrestrial plants. Since bifenthrin has
residential outdoor uses, vegetative vigor and seedling emergence
studies are required.  These phytotoxicity data are needed to evaluate
the level of pesticide exposure to non-target terrestrial and aquatic
plants and to assess the impact of pesticides on endangered and
threatened plants.

Guideline Number: 850.4400

Study Title: Aquatic Vascular Plant Growth-Lemna spp. Tier I/II

No acceptable studies for bifenthrin have been submitted for vascular
aquatic plants. The Agency has finalized its update to the data
requirements in 40 CFR Part 158.  In these updated data requirements,
which were promulgated on October 26, 2007, vascular plant testing is
required for pesticides such as bifenthrin with outdoor uses.

Guideline Number:  850.5400

Study Title:  Algal toxicity test, Tier I/II

No toxicity data are currently available to assess the risk of
bifenthrin to aquatic nonvascular plants. Since bifenthrin has
residential outdoor uses, Tier I/II aquatic nonvascular plant studies
are required.  These phytotoxicity data are needed to evaluate the level
of pesticide exposure to non-target aquatic plants and to assess the
impact of pesticides on endangered and threatened plants.

Table 7.2 lists the status of the ecological effects data requirements
for bifenthrin.

Table 7.2. Ecological Effects Data Requirements for Bifenthrin

Data Requirement

Use

Pattern1	Does EPA Have

Data To Satisfy

This Requirement?

(Yes, No, or Partially)

Bibliographic

Citation	Must Additional

Data Be Submitted

Under FIFRA 3(c)(2)(B)?

§158.490 TERRESTRIAL ORGANISMS

71-1(a)   Acute Avian Oral, Quail/Duck 	1,2	Partially	ACC251727
Fletcher/1984	Yes1

71-2(a)   Acute Avian Diet, Quail              	1,2	Yes	ACC251727
Fletcher/1984	No

71-2(b)   Acute Avian Diet, Duck              	1,2	Yes	ACC251727
Fletcher/1984	No

71-3       Wild Mammal Toxicity               	1,2	N/A

71-4(a)   Avian Reproduction Quail	1,2	Yes	ACC264644

Huntington/1987	No

71-4(b)   Avian Reproduction Duck          	1,2	Yes	ACC264644

Huntington/1987	No

§158.630  AQUATIC ORGANISMS TESTING

72-1(a)   Acute Fish Toxicity Bluegill         	1,2	Yes	ACC 251727

Hoberg 1983	No

72-1(b)   Acute Fish Toxicity (TEP)	1,2	No	N/A	No*

72-1(c)   Acute Fish Toxicity Rainbow  Trout          	1,2	Yes	ACC
251727

Hoberg 1983	No

72-2(a)   Acute Aquatic Invertebrate           	1,2	Yes	41156501	No

72-2(b)   Acute Aquatic Invertebrate   (TEP)         	1,2	No	N/A	No*

72-3(a)   Acute Est/Mar Toxicity Fish         	1,2	Yes	264646

Battelle 1987	No

72-3(b)   Acute Est/Mar Toxicity Mollusk    	1,2	Yes	40383501	No

72-3(c)   Acute Est/Mar Toxicity Shrimp    	1,2	Yes	264647

Battelle 1987	No

72-3(d)   Acute Est/Mar Toxicity Fish (TEP)	 	1,2	No	N/A	No*

72-3(e)   Acute Est/Mar Toxicity Mollusk  (TEP)  	1,2	No	N/A	No*

72-3(f)   Acute Est/Mar Toxicity Shrimp  (TEP)  	1,2	No	N/A	Yes

72-4(a)   Early Life Stage Fish                  	1,2	No (Saltwater)	N/A
Yes

72-4(b)   Life Cycle Aquatic Invertebrate (freshwater) 	1,2	Yes	41156501
No

850.1350  Life Cycle Aquatic Invertebrate (saltwater)	1,2	No	N/A	Yes

72-5   Life Cycle Freshwater Fish         	1,2	No	40791301	Yes3

72-6   Aquatic Organism Accumulation	1,2	N/A

72-7(1)   Simulated Aquatic Field Study	1,2	N/A

72-7(b)   Actual Aquatic Field Study	1,2	N/A

850.1730  Bioaccumulation in Fish	1,2	Yes	264642 ( 163094, 163095)	No

850.1950  Accumulation in Aquatic Non-target Organisms	1,2	Yes	42529902
Study currently in review

850.1010  Aquatic Invertebrate Acute Toxicity (Hyalella azteca)	1, 2	No
NA	Yes

850.1735 Whole sediment:  acute freshwater invertebrates (C. dilutus)	1,
2	Yes	46591502	Study currently in review

850.1740 Whole sediment:  acute marine invertebrates	1, 2	No	NA	No2

Whole sediment:  chronic invertebrates freshwater (H. azteca)	1, 2	No	NA
Yes

Whole sediment:  chronic invertebrates freshwater (C. dilutus)	1, 2	No
NA	Yes

Whole sediment:  chronic invertebrates marine (L. plumulosus)	1, 2	Yes
46591501	Yes

§158.540 PLANT PROTECTION

122-1(a) Seed Germ, Seedling Emergence TEP	1,2	No	NA	Yes

122-2     Aquatic Plant Growth	1,2	No	NA	Yes

122-1(b)  Vegetative Vigor TEP	1,2	No	NA	Yes

123-1(a) Seed Germ./Seedling Emerg.	1,2	No	NA	No4

123-1(b) Vegetative Vigor	1,2	No	NA	No4

123-2     Aquatic Plant Growth	1,2	No	NA	No5

§158.490 NONTARGET INSECT TESTING

141-1     Honey Bee Acute Contact           	1,2	Yes	VAOTAL01

Atkins 1981	No

141-2     Honey Bee Residue on Foliage   	1,2	Yes<PHONE_NUMBER>	No

141-5     Field Test for Pollinators	1,2	NA

1 Data are required for one passerine species and either on waterfowl or
one upland game bird species. At this time, only acute oral tests for a
game bird species and a waterfowl have been submitted.

2 This data requirement was previously listed as “held in reserve”.
Based on the requirements listed in 40 CFR Part 158, the persistent
half-life of bifenthrin meets the criteria for chronic whole sediment
tests, not acute. Therefore, only chronic sediment tests are requested
at this time.

3 This study is classified as invalid based on current review. Previous
studies listed the study as supplemental. Should the registrant choose
to conduct the study on an estuarine/marine fish, then the additional
requirement for an ELS study with estuarine/marine fish could be
satisfied with just one study.

4 Required if a tested terrestrial species exhibits a 25 percent or
greater detrimental effect in the Tier I study.

5 Required if a tested aquatic species exhibits a 50 percent or greater
detrimental effect in a Tier I study.

* Does not trigger submission of TEP data:

According to the Part 158 data requirements, testing on the typical
end-use product may be required for aquatic toxicity tests when any of
the following conditions exist:

	1.  The end-use product will be introduced directly into the aquatic
environment.

2.  The maximum expected environmental concentration or estimated
environmental concentration in the aquatic environment is greater than
or equal to one-half the LC50 or EC50 of the TGAI.

3.  An ingredient in the end-use formulation other than the active
ingredient is expected to enhance the toxicity of the active ingredient
or cause toxicity to aquatic organisms.

Previous assessments indicated that the expected environmental
concentrations of bifenthrin in aquatic environments were based on the
solubility limit in water (0.014 ppb). In freshwater and
estuarine/marine tests conducted with Bifenthrin technical, the most
toxic 96-hour LC50s were 0.15 ug/L for Rainbow trout, 1.6 ug/L for
Daphnia, 17.5 µg/L for sheepshead minnow and 0.004 µg/L for Mysid
shrimp. Therefore, Bifenthrin fulfills the second requirement for TEP
testing for estuarine/marine invertebrate species only.

8.	References

Amweg, E.L., D.P.Weston, and N.M. Ureda. 2005. Use and Toxicity of
Pyrethroid Pesticides in the Central Valley, California, USA.
Environmental Toxicology and Chemistry, Vol. 24, No. 4, pp. 966–972

Amweg, E.L. D.P. Weston, J. You and M.J. Lydy.  2006.  Pyrethroid
Insecticides and Sediment Toxicity in Urban Creeks from California and
Tennessee.  Environ. Sci. Technol., 2006, 40 (5), pp 1700–1706.

Amweg, E.L., D.P. Weston, C.S. Johnson, J. You and M.L. Lydy (2006)
Effect of Piperonyl Butoxide on Permethrin Toxicity in the Amphipod
Hyalella azteca.  Environ. Tox. Chem. 25 (7): 1817-1825.

Amweg, E.L. and D.P. Weston. 2007. Whole-Sediment Toxicity
Identification Evaluation Tools for Pyrethroid Insecticides: I.
Piperonyl Butoxide Addition. Environ. Toxicol. & Chem., Vol. 26, No. 11,
pp. 2389–2396, 2007

Anderson BS, Phillips BM, Hunt JW, Connor V, Richard N, and RS
Tjeerdema. 2006. Identifying primary stressors impacting
macroinvertebrates in the Salinas River (California, USA):  Relative
effects of pesticides and suspended particles. Environ. Pollution., 141,
pp 402 – 408.

Armitage, J.M., & Gobas, F.A.P.C. 2007. A terrestrial food-chain
bioaccumulation model for POPs. Environmental Science and Technology,
41, 4019-4025.

Barile, F.A. 2004. Clinical Toxicology:  Principles and Mechanisms. Boca
Raton, FL:

CRC Press.

Budd, R, S. Bondarenko, D. Haver, J. Kabashima, and J. Gan.  2007.
Occurrence and Bioavailability of Pyrethroids in a Mixed Land Use
Watershed.  J. Environ. Qual. 36: 1006–1012 (2007).

California Air Resources Board.  2001.  Report for the Application and
Ambient Air Monitoring for Propargite and Bifenthrin in Fresno and Kings
Counties.  Bifenthrin Project No. C99-033 (Ambient) and C99-033a
(Application); Propargite Project No. C99-032 (Ambient) and C99-032a
(Application).  Report dated 8/8/01.  California Environmental
Protection Agency.

Clark, J.M and F. Matsumura. 1987.  The action of two classes of
pyrethroids on the inhibition of brain Na-Ca and Ca + Mg ATP
hydrolyzing activities of the American cockroach, Comp. Biochem.
Physiol. C. 86 (1987) (1), pp. 135–145.

Corbin, M, W. Eckel, M. Ruhman, D. Spatz, N. Thurman, R. Gangaraju, T.
Kuchnicki, R. Mathew, and I. Nicholson.  2006.  NAFTA Guidance Document
for Conducting Terrestrial Field Dissipation Studies.  Available at url:
  HYPERLINK
"http://www.epa.gov/oppefed1/ecorisk_ders/terrestrial_field_dissipation.
htm"
http://www.epa.gov/oppefed1/ecorisk_ders/terrestrial_field_dissipation.h
tm  (accessed 03/11/10).

Dai, P-L, Q Wang, J-H Sun, F Liu, X Wang, Y-Y Wu and T Zhou. 2010.
Effects of sublethal concentrations of Bifenthrin and Deltamethrin on
fecundity, growth, and development of the honeybee (apis mellifera
ligustica). Environ. Toxicol. Chem. 29:644–649.

Delgado-Moreno, L, L. W u and J. Gan. 2010. Effect of Dissolved Organic
Carbon

on Sorption of Pyrethroids to Sediments. Environ. Sci. Technol. In
press.

Di Toro, DM, CS Zarba, DJ Hansen, WJ Berry, RC Swartz, CE Cowan, SP
Pavlou, HE Allen, NA Thomas and PR Paquin. 1991.  Technical basis for
establishing sediment quality criteria for nonionic organic chemicals
using equilibrium partitioning. Environ. Toxicol. Chem. 10:1541-1583.

Ding, Y., A.D. Harwood, H.M. Foslund, and M.J. Lydy.  2010.
Distribution and Toxicity of Sediment-Associated Pesticides in Urban and
Agricultural Waterways from Illinois, USA.  Environmental Toxicology and
Chemistry, Vol. 29, No. 1, pp. 149–157, 2010.

Federoff, N.E. and J.L. Meléndez.  2008.  EFED New Use Registration for
Bifenthrin to be used on Bushberry Subgroup 13-B and Leaf Petiole
Subgroup 4-B. Also Includes a Review of Submitted 6A2 Data (I017659).
Memorandum to G. LaRocca and B. Alexander dated 1/29/08.  DP Barcodes
D341634, D341635, D341636 and D341637.  Environmental Fate and Effects
Division, OPP, OPPTS, USEPA.

Food and Agriculture Organization of the United Nations.  FAO PESTICIDE
DISPOSAL SERIES 8.  Assessing Soil Contamination: A Reference Manual.
Appendix 2. Parameters of pesticides that influence processes in the
soil.  Editorial Group, FAO Information Division: Rome, 2000.
HYPERLINK "http://www.fao.org/DOCREP/003/X2570E/X2570E00.htm"
http://www.fao.org/DOCREP/003/X2570E/X2570E00.htm

Gan, J., S.J. Lee, W.P. Liu, D.L. Haver, and J.N. Kabashima. 2005.
Distribution and Persistence of Pyrethroids in Runoff Sediments.  J.
Environ. Qual. 34:836–841 (2005).

Gobas, F.A.P.C., B.C. Kelly and J.A. Arnot. 2003. Quantitative structure
activity relationships for predicting the bioaccumulation of POPs in
terrestrial food webs.  QSAR Comb. Sci. 22:329-336.

Greenberg, L., M.K. Rust, J.H. Klotz, D. Haver, J.N. Kabashima, S.
Bondarenko and J. Gan.  2010.  Impact of ant control technologies on
insecticide runoff and efficacy.  Pest Manag Sci 2010; 66: 980–987

Hintzen, E.P., M.J. Lydy, and J.B. Belden. 2009. Occurrence and
potential toxicity of pyrethroids and other insecticides in bed
sediments of urban streams in central Texas. Environ Pollut
157:110–116.

Hodgson, E., & Smart, R. C. (Eds.).  2001.  Introduction to Biochemical
Toxicology

(Third ed.). New York: Wiley-Interscience.

Holmes, RW, BS Anderson, JW Hunt, DB Crane, A Mekebri and V Connor.
2008. “Statewide Investigation of the Role of Pyrethroid Pesticides in
Sediment Toxicity in California’s Urban Waterways.” Environ. Sci.
Technol. 2008, 42, 7003–7009.

Jiang, W., J. Gan and D. Haver.  In press.  Sorption and Desorption of
Pyrethroid Insecticide Permethrin on Concrete.  Environ. Sci. & Technol.
 (In press).  Accepted for publication November 22, 2010.

Jiang, W., K. Lin, D. Haver, S. Qin, G. Ayre, F. Spurlock, and J. Gan.
2010.  Wash-off Potential of Urban Use Insecticides on Concrete
Surfaces.  Environ. Tox. Chem. 29(6), pp. 1203–1208, 2010.

Jorgenson, B., and T. Young.  2010.  Formulation Effects and the
Off-Target Transport of Pyrethroid Insecticides from Urban Hard
Surfaces.  Environ. Sci. Technol. 2010, 44, 4951–4957.

Laskowski, D.A., 2002. Physical and chemical properties of pyrethroids.
Rev. Environ. Contam. Toxicol. 2002; 174:49-170.

LeBlanc, L. & B. Perkins. 2009. Pyrethroid Analysis for Maine Board of
Pesticide Control.  University of Maine Food and Chemical Safety
Laboratory, Orono Maine.  An e:mail communication from G. Fish to R.
Gebken, dated 11/02/09 and forwarded to EFED on 11/19/09.  Original
communication from L. LeBlanc to G. Fish and H. Jennings, dated
05/25/09.

Maund, S.J., M.J. Hamer, M.C.G. Lane, E. Farrelly, J.H. Rapley, U.M.
Goggin, and W.E. Gentle.  2001. Partitioning, Bioavailability, and
Toxicity of the Pyrethroid Insecticide Cypermethrin in Sediments.
Environmental Toxicology and Chemistry, 21 (1):9-15.

Matsumura, F. 1985. Toxicology of insects. 2nd ed. Plenum New York.

Meléndez, J.L. and N.E. Federoff.  2005.  EFED Chapter for the New Use
of Bifenthrin (BISTAR® WT) as a Wood Preservative.  Memorandum to S.
Stanton and G. LaRocca dated 3/9/05.  DP Barcode D290992.  Environmental
Fate and Effects Division, OPP, OPPTS, USEPA.

Meléndez, J.L. and N.E. Federoff.  2007.  EFED Science Chapter for the
Section 3 and IR-4 New Uses of Bifenthrin on Mayhew, Vegetable Roots,
Except Sugar Beets, Peanut, Soybean, and Fruiting Vegetables Subgroup B.
 Memorandum to S. Brothers, A. Balexand and G. LaRocca dated 9/27/07.
DP Barcodes D336608, D336609 and D336610.  Environmental Fate and
Effects Division, OPP, OPPTS, USEPA.

Rexrode, M. and J.L. Meléndez.  2003.  EFED’s rationale for choosing
Cypermethrin, Esfenvalerate, Bifenthrin, and Cyfluthrin for sediment
testing as discussed with the Pyrethroid Working Group (PWG).
Memorandum to M. Johnson & G. LaRocca dated 12/22/03.  Environmental
Fate and Effects Division, OPP, OPPTS, USEPA.

Rexrode, M. and J.L. Meléndez.  2006.  Tolerance Petition for the Use
of Bifenthrin on Leafy Brassica Greens, Peas and Beans (dry), Tobacco,
Cilantro, Okra and Tuberous and Corm Vegetables.   SEQ CHAPTER \h \r 1
Incremental Ecological Effects Risk Assessment Due to the New Uses.
Memorandum to S. Brothers, S. Jackson, B. Alexander, D. Rosenblatt and
G. LaRocca dated 2/21/06.  DP Barcodes D310879, D310881, D313300,
D313728, D313741, D322221 and D322222.  Environmental Fate and Effects
Division, OPP, OPPTS, USEPA.

Stout II, D.M., K Bradham, P.P. Egeghy, P. Jones, C.W. Croghan, P.A.
Ashley, E. Pinzer, W. Friedman, M.C. Brinkman, M.G. Nishioka and D.C.
Cox.  2009.  American Healthy Homes Survey: A National Study of
Residential Pesticides Measured from Floor Wipes.  Environ. Sci.
Technol., 2009, 43, 4294–4300.

Trimble, A.J, D.P. Weston, J.B. Belden, and M.J. Lydy.  2009.
Identification and Evaluation of Pyrethroid Insecticide Mixtures in
Urban Sediments.  Environ Toxicol & Chem 26 (8) pp. 1687–1695  (from
ET&C paper in press).

U.S. Environmental Protection Agency.  1998.  Guidelines for Ecological
Risk Assessment.  Risk Assessment Forum, Office of Research and
Development,  Washington, D.C.  EPA/630/R-95/002F.  April 1998.

U.S. Environmental Protection Agency. 1999. FIFRA Scientific Advisory
Panel Meeting, February 23, 1999 held at the Holiday Inn Hotel,
Arlington, VA. SAP Report No. 99-03A. March 25, 1999. Office of
Pesticide Programs. Available at url:   HYPERLINK
"http://www.epa.gov/scipoly/sap/meetings/1999/022399_mtg.htm#materials"
http://www.epa.gov/scipoly/sap/meetings/1999/022399_mtg.htm#materials
(Accessed December 15, 2009)

U.S. Environmental Protection Agency.  2000.  Risk Characterization
Handbook.  Science Policy Council, U.S. Environmental Protection Agency,
Washington, D.C.  20460.  EPA 100-B-00-002.  December 2000.

U.S. Environmental Protection Agency. 2002. Technical Basis for the
derivation of Equilibrium Partitioning Sediment Guidelines (ESGs) for
the Protection of Benthic Organisms: Nonionic Organics [Draft].  EPA
Document No. 822R02041. October 2002.

U.S. Environmental Protection Agency.  2004.  Overview of the Ecological
Risk Assessment Process in the Office of Pesticide Programs, U.S.
Environmental Protection Agency.  Endangered and Threatened Species
Effects Determinations.  Office of Prevention, Pesticides and Toxic
Substances, Office of Pesticide Programs, Washington, D.C.  January 23,
2004.

U.S. Environmental Protection Agency.  2005.  Generic Format and
Guidance for the Level I Screening Ecological Risk Assessments Conducted
in the Environmental Fate and Effects Division.  Office of Pesticide
Programs, Washington, D.C.  January 24, 2005.

U.S. Environmental Protection Agency. 2008. OPPTS 835.6100 Terrestrial
Field Dissipation. EPA 712-C-08-020. October 2008. Office of Prevention,
Pesticides, and Toxic Substances.  United States Environmental
Protection Agency. Available at   HYPERLINK
"http://www.epa.gov/opptsfrs/publications/835_6100.pdf"
http://www.epa.gov/opptsfrs/publications/835_6100.pdf  (Accessed
December 16, 2009).

U.S. Environmental Protection Agency. 2009.  A Set of Scientific Issues
Being Considered by the EPA Regarding: Evaluation of the Common
Mechanism of Action of Pyrethroid Pesticides.  SAP Minutes No. 2009-07.
FIFRA SAP Meeting held 6/16/09 in Arlington, VA.  Meeting Minutes dated
9/9/09.

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.

Weston, D.P., J. You and M.J. Lydy. 2004.  Distribution and Toxicity of
Sediment-Associated Pesticides in Agriculture-Dominated Water Bodies of
California’s Central Valley.  Environ. Sci. Technol. 2004, 38,
2752-2759.

Weston, D.P., R.W. Holmes, J. You and M.J. Lydy.  2005.  Aquatic
Toxicity Due to Residential Use of Pyrethroid Insecticides.  Environ.
Sci. Technol., 2005, 39 (24), pp 9778–9784.

Weston, D.P. Amweg, E.L., Mekebri, A., Ogle, R.S. and M.J. Lydy. (2006).
Aquatic effects of aerial spraying for mosquito control over an urban
area. Environ. Science Technol. 40(18): 5817-22.

Weston, D.  2007. Impacts of Pyrethroid Pesticides on Water Quality from
Urban and Agricultural Sectors.  Conference Proceedings;  California
Plant and Soil Conference: Opportunities for California Agriculture.
California Chapter of the American Society of Agronomy, pp. 35-37.

Weston, D.P., J. You, A.D. Harwood and M.J. Lydy. 2009a. Whole Sediment
Toxicity Identification Evaluation Tools for Pyrethroid Insecticides:
III. Temperature Manipulation.  Environ. Tox. & Chem., Vol. 28, No. 1,
pp. 173–180, 2009

Weston, D.P., R.W. Holmes, and M.J. Lydy.  2009b.  Residential runoff as
a source of pyrethroid pesticides to urban creeks.  Environmental
Pollution 157 (2009) 287–294

Weston, D.P. and M.J. Lydy.  2010.  Urban and Agricultural Sources of
Pyrethroid Insecticides to the Sacramento-San Joaquin Delta of
California.  Environ. Sci. Technol. 2010, 44, 1833–1840.

9.	Fate and Eco-Toxicity Bibliography

161-1       Hydrolysis

132518	FMC Corp. (1983) FMC 54800 Insecticide. (Compilation; unpublished
study received Nov 3, 1983 under 279-EX-101; CDL:251725-A)

132539	Herbst, R.; Kikta, E. (1983) Hydrolysis of FMC 54800: P-0701.
(Un- published study received Nov 3, 1983 under 279-EX-101; submitted by
FMC Corp., Philadelphia, PA; CDL:251728-A)

152860	FMC Corp. (1984) Chemistry: Environmental Fate [of FMC 54800].
Un- published study. 10 p.

161-2       Photodegradation-water

163084	Wu, J. (1986) Photodegradation of FMC 54800 in Aqueous Solution:
Rept. No. P-1349. Unpublished study prepared by FMC Corp., Agricultural
Chemical Group. 33 p.

161-3       Photodegradation-soil

163085	Wu, J. (1986) Photodegradation of FMC 54800 in/on Soil: Rept. No.
P-1351. Unpublished study prepared by FMC Corp., Agricultural Chemical
Group. 38 p.

162-1       Aerobic soil metabolism

132540	Bixler, T.; Gross, E.; Willow, E.; et al. (1983) FMC 54800
Aerobic Soil Degradation: P-0712. (Unpublished study received Nov 3,
1983 under 279-EX-101; submitted by FMC Corp., Philadelphia, PA;
CDL:251728-B)

141202	Reynolds, J. (1984) Aerobic Soil Metabolism of FMC 54800 - Fate
of Acid Cyclopropyl ring)-[Carbon 14] FMC 54800 and Metabolite
Characterization: P-0872. Unpublished study prepared by FMC Corp. 22 p.

152266	Reynolds, J. (1984) Aerobic Soil Metabolism of FMC 54800 - Fate
of Alcohol (Phenyl)-[Carbon-14] FMC 54800 in a Sandy Loam Soil after 21
Days. Unpublished study prepared by FMC Corp. 17 p.

152860	FMC Corp. (1984) Chemistry: Environmental Fate [of FMC 54800].
Un- published study. 10 p.

162-2       Anaerobic soil metabolism

163088	Reynolds, J. (1986) Metabolism of Acid (Cyclopropyl Ring)-[carbon
14] and Alcohol(Phenyl Ring-[carbon 14] FMC 54800 in Soil under
Anaerobic Conditions: Rept. No. P-1338. Unpublished study pre- pared by
FMC Corp., Agricultural Chemical Group. 26 p.

163-1       Leach/adsorp/desorption

132541	Kinne, L.; Froelich, L. (1983) Soil Mobility of FMC 54800:
P-0721. (Unpublished study received Nov 3, 1983 under 279-EX-101; sub-
mitted by FMC Corp., Philadelphia, PA; CDL:251728-C)

141203	Froelich, L. (1984) Soil Adsorption/Desorption Characteristics of
FMC 54800: P-0797. Unpublished study prepared by FMC Corp. 19 p.

163089	Kinne, L. (1984) Mobility of FMC 54800 Aged Soil Residues: Rept.
No. P-1029; Study No. S-182-84-19. Unpublished study prepared by FMC
Corp., Agricultural Chemical Group. 21 p.

163-2       Volatility - lab

163090	Ferraro, C.; Zuccarello, W. (1986) FMC 54800 Laboratory
Volatility Study: The Volatility of Active Ingredient in Capture 2.0 EC
Insecticide/Miticide from Soil under Varying Conditions of Temp-
erature, Soil Moisture and Air Flow Rate: Rept. No. P-1463. Unpublished
study prepared by FMC Corp., Agricultural Chemical Group. 24 p.

163223	Hu, H. (1983) Vapor Pressure of FMC 54800: Rept. No. CGP-83-1;
Pr. No. G182.305. Unpublished study prepared by FMC Corp., Center
Technical Dept. 17 p.

41220601	Bowman, B. (1989) Laboratory Volatility from Soil of FMC 54800:
Proj. ID PC 0119. Unpublished study prepared by Analytical Bio-
Chemistry Laboratories. 40 p.

164-1       Terrestrial field dissipation

163091	Stearns, J. (1984) Dissipation of Residues of FMC 54800 in Soils
Treated with Capture 2.0 EC: Rept. No. RAN-0141. Unpublished study
prepared by FMC Corp., Agricultural Chemical Group. 25 p.

41673101	Hicks, S. (1990) Bifenthrin Field Dissipation Study .: Lab Pro-
ject Number: 182E4188E1: 882037-1: PC-0147. Unpublished study prepared
by Siemer & Associates, Inc. 383 p.

41673102	Culligan, J. (1990) Terrestrial Field Dissipation: Magnitude of
the Residue of Bifenthrin and 4'-Hydroxy-Bifenthrin in Soil: Lab Project
Number: 182E4188E1-1. Unpublished study prepared by FMC Corp. 91 p.

41673103	Stenzel, J. (1990) Interim Report of the Terrestrial Field
Dissipation of Bifenthrin and 4'-Hydroxy-Bifenthrin in/on Bare Soil: Lab
Project Number: 182E4189R1. Unpublished study prepared by FMC Corp. 118
p.

42339201	Stenzel, J.; Culligan, J. (1991) Final Report of the 1989 Study
of the Terrestrial Field Dissipation of Bifenthrin in/on Bare Soil in
Champaign, Il: Lab Project Number: P-2639: 182E4189R1. Unpublished study
prepared by FMC Corp. 117 p.

42339203	Culligan, J. (1991) Terrestrial Field Dissipation--Bifenthrin
and 4'-Hydroxy-Bifenthrin in Soil: Lab Project Number: 18234188E1-1.
Unpublished study prepared by FMC Corp. 114 p.

165-4       Bioaccumulation in fish

163094	Surprenant, D. (1985) Accumulation and Elimination of [Carbon
14]- Residues by Bluegill (Lepomis macrochirus) Exposed to [Carbon
14]-FMC 54800: Rept. #BW-85-4-1765; Bionomics Study #282.1184. 6108.140.
Unpublished study prepared by Springborn Bionomics, Inc. 46 p.

163095	Tullman, R. (1986) Analysis of [Carbon 14]-FMC 54800 Residues in
Bluegill Sunfish and Water: Rept. No. P-1342. Unpublished study prepared
by FMC Corp., Agricultural Chemical Group. 37 p.

165-5       Bioaccum-aquatic non-target

42529902	Surprenant, D. (1988) Bioavailability, Accumulation and Aquatic
Toxicity of carbon 14|-FMC 54800 Residues Incorporated into Soil: Lab
Project Number: BW-85-12-1894: 282-0185-6109-000. Unpublished study
prepared by Springborn Bionomics Inc. 87 p.

NON Guideline Section Selections

46535601	Cheplick, J. (2005) National Runoff, Erosion, and Leaching
Assessment with the Pesticide Root Zone Model (PRZM): Pyrethroid.
Project Number: WEI/794/05. Unpublished study prepared by Waterborne
Environmental, Inc. (WEI). 14 p.

46535602	Cheplick, J. (2005) Direct Observation Based Method to Assign
Topographic Factor (LS) to Areas of Concern with Quantified Statistical
Confidence: (Pyrethroid). Project Number: WEI/794/05. Unpublished study
prepared by Waterborne Environmental, Inc. (WEI). 12 p.

46535603	Holmes, C. (2005) Proposed Methodology to Redistribute Doane
Pesticide Use Data Based on NASS 2002 Census of Agriculture Data:
(Pyrethroid). Project Number: WEI/794/05. Unpublished study prepared by
Waterborne Environmental, Inc. (WEI). 14 p.

46535604	Ritter, A. (2005) Approach for the Monte Carlo Assessment (Task
I) of the Sensitivity Analysis of Synthetic Pyrethroid Sediment Exposure
Assessments to Drift and Runoff Entry Routes. Project Number:
WEI/794/05. Unpublished study prepared by Waterborne Environmental, Inc.
(WEI). 49 p.

47454101	Chen, A. (2007) Determination of Bifenthrin Residues Leaching
from Wood Treated with Bistar WT Insecticide. Project Number:
182WAT07PS01, P/3932. Unpublished study prepared by FMC Corp. 36 p.

47454102	Enriquez, M. (2006) Determination of Bifenthrin Leaching From
Wood Treated with 3% Bifenthrin ME (Wood Preservative Formulation).
Project Number: A/25/05/05. Unpublished study prepared by Battelle
Europe. 52 p.

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

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

47647801	Hanzas, J.; Stone, C.; Toth, B.; et al. (2008) Bifenthrin and
Beta-Cyfluthrin: Quantification of Pyrethroid Runoff Losses from Treated
Turfgrass Under Over-Irrigation Conditions and Simulated Rainfall: Final
Report. Project Number: 082018, SEI001. Unpublished study prepared by
Stone Environmental, Inc., CRG Marine Laboraties, Inc. and Agvise
Laboratories. 280 p.

163080	Martin, F. (1985) Storage Stability of Bifenthrin in/on Various
Crops and Soils: Rept. No. P-1268. Unpublished study prepared by FMC
Corp., Agricultural Chemical Group. 23 p.

163081	Martin. F. (1986) Storage Stability of Bifenthrin in/on Various
Crops and Soils: Rept. No. P-1459. Unpublished study prepared by FMC
Corp., Agricultural Chemical Group. 26 p.

71-1       Avian Single Dose Oral Toxicity

132532	Fletcher, D. (1983) Report to ...: Acute Oral Toxicity Study with
FMC 54800 Technical in Bobwhite Quail: BLAL No. 83 QD 30; FMC #A83-963.
(Unpublished study received Nov 3, 1983 under 279- EX-101; prepared by
Bio-Life Assoc., Ltd., submitted by FMC Corp., Philadelphia, PA;
CDL:251727-A)

132534	Fletcher, D. (1983) Report to ...: Acute Oral Toxicity Study with
FMC 54800 Technical in Mallard Ducks: BLAL No. 83 DD 23; FMC #A83-964.
(Unpublished study received Nov 3, 1983 under 279-EX- 101; submitted by
FMC Corp., Philadelphia, PA; CDL:251727-C)

71-2       Avian Dietary Toxicity

132533	Fletcher, D. (1983) Report to ...: 8-Day Dietary LC50 Study with
FMC 54800 Technical in Bobwhite Quail: BLAL No. 83 QC 34; FMC No.
A83-965. (Unpublished study received Nov 3, 1983 under 279-EX-101;
prepared by Bio-Life Assoc., Ltd., submitted by FMC Corp., Philadelphia,
PA; CDL:251727-B)

132535	Fletcher, D. (1983) Report to ...: 8-Day Dietary LC50 Study with
FMC 54800 Technical in Mallard Ducklings: BLAL No. 83 DC 34; FMC No.
A83-966. (Unpublished study received Nov 3, 1983 under 279-EX-101;
submitted by FMC Corp., Philadelphia, PA; CDL: 251727-D)

71-4       Avian Reproduction

163097	Roberts, N.; Phillips, C.; Anderson, A.; et al. (1986) The
Effects of Dietary Inclusion of FMC 54800 on Reproduction in the Bob-
white Quail: Rept. No. FCC 57A/851423. Unpublished study pre- pared by
Huntingdon Research Centre Ltd. 337 p.

163098	Roberts, N.; Phillips, C.; MacDonald, I. (1986) The Tissue
Residues of FMC 54800 in the Bobwhite Quail following a Reproduction
Study: Rept. No. FCC 57(b)/851567. Unpublished study prepared by
Huntingdon Research Centre Ltd. 54 p.

163099	Roberts, N.; Phillips, C.; Anderson, A.; et al. (1986) The Effect
of Dietary Inclusion of FMC 54800 on Reproduction in the Mallard Duck:
Rept. No. FCC 58A/851430. Unpublished study prepared by Huntingdon
Research Centre Ltd. 239 p.

163100	Roberts, N.; Phillips, C.; MacDonald, I. (1986) The Tissue
Residues of FMC 54800 in the Mallard Duck following a Reproduction
Study. Rept. No. FCC 58(b)/851316. Unpublished study prepared by
Huntingdon Research Centre Ltd. 51 p.

40266301	Roberts, N.; Phillips, C.; Anderson, A.; et al (1987) The
Effects of Dietary Inclusion of FMC 54800 on Reproduction in the Bob-
white Quail (Revised): Lab Proj. ID FCC 57A/851423 and FCC 57(b) 851567.
Unpublished study revised by Huntington Research Cent- re, Ltd. 368 p.

72-1       Acute Toxicity to Freshwater Fish

132536	LeBlanc, G.; Hoberg, J. (1983) Acute Toxicity of FMC-54800
Technical to Bluegill ...: Bionomics Report #BW-83-8-1445; FMC Study No.
A83-987. (Unpublished study received Nov 3, 1983 under 279-EX-101;
prepared by EG & G, Bionomics, submitted by FMC Corp., Philadelphia, PA;
CDL:251727-F)

163156	Hoberg, J. (1983) Acute Toxicity of FMC-54800 Technical to
Rainbow Trout (Salmo gairdneri): FMC Study No. A83-967. Unpublished
study prepared by EG&G Bionomics. 21 p.

72-2       Acute Toxicity to Freshwater Invertebrates

132537	LeBlanc, G.; Surprenant, D. (1983) Acute Toxicity of FMC 54800
Technical to Daphnia magna: Bionomics Report #BW-83-8-1444; FMC Study
#A83-986. (Unpublished study received Nov 3, 1983 under 279-EX-101;
prepared by EG & G, Bionomics, submitted by FMC Corp., Philadelphia, PA;
CDL:251727-G)

163139	Hoberg, J.; Noll, M.; Henzel, S.; et al. (1985) [Carbon 14] -
FMC- 54800: D. magna: 21-Day Chronic (Flow-through): Study # 282-
0484-6102-130. Unpublished raw data prepared by Springborn Bionomics,
Inc. 97 p.

72-3       Acute Toxicity to Estuarine/Marine Organisms

163101	Barrows, M. (1986) Acute Toxicity of FMC 54800 to Sheepshead
Minnow (Cyprinodon variegatus): Final Report. Unpublished FMC study no.
A85-1874 prepared by Battelle, New England Marine Research Lab. 304 p.

163102	Barrows, M. (1986) Acute Toxicity of FMC 54800 to Mysid Shrimp
(Mysidopsis bahia): Final Report: Unpublished FMC Study No. A85- 1875
prepared by Battelle, New England Marine Res. Lab. 443 p.

163103	Ward, G. (1986) Acute Toxicity of FMC 54800 Tech. on Shell Growth
of the Eastern Oyster (Crassostrea virginica): Revised Toxicity Rept.:
ESE No. 85-322-0950-2130. Unpublished study prepared by Environmental
Science and Engineering, Inc. 80 p.

40266501	Ward, G. (1987) Acute Effect of FMC 54800 Technical on New
Shell Growth of the Eastern Oyster (Crassostrea virginica): Study No.
A86-2203; Lab Project ID: 85-322-0960-2130. Unpublished study prepared
by Environmental Science and Engineering, Inc. 37 p.

40383501	Ward, G. (1987) Acute Toxicity of FMC 54800 Technical to
Embryos and Larvae of the Eastern Oyster (Crassostrea virginica):
Laboratory Project ID ESE No. 87-318-0200-2130: FMC Corporation Study
No. A87-2264. Unpublished study prepared by Environmental Science and
Engineering, Inc. 71 p.

72-4       Fish Early Life Stage/Aquatic Invertebrate Life Cycle
Study

40275401	Hoberg, J.; Nicholson, R.; Grandy, K.; et al. (1985) The
Chronic Toxicity of [Carbon 14]-FMC-54800 Daphnia magna under Flow-
through Conditions: Laboratory ID: 282-0484-6102-130. Unpub- lished
study prepared by Springborn Bionomics, Inc. 35 p.

40569402	Drenner, R.; Hoagland, K.; Smith, J.; et al. (1988)
Experimental Microcosm Study of the Effects of Sediment-Bound Bifenthrin
on Gizzard Shad and Plankton: FMC Study No. A87-2414. Unpublished study
prepared by Texas Christian University. 197 p.

41156501	Burgess, D. (1989) Chronic Toxicity of Carbon 14|-FMC 54800 to
Daphnia magna under Flow-through Test Conditions: ABC Final Report No.
36980. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 244 p.

41640501	Ward, T.; Boeri, R. (1990) Life Cycle Toxicity of Bifenthrin
FMC 54800 to the Mysid, Mysidopsis bahia: Lab Project Number: 9080/ FMC.
Unpublished study prepared by Resource Analysts, Inc., EnviroSystems
Div. 49 p.

42338801	Boeri, R.; Ward, T. (1991) Life Cycle Toxicity of Bifenthrin
(FMC 54800) to the Mysid, Mysidopsis bahia: Lab Project Number:
A90-3318. Unpublished study prepared by Resource Analysts, Inc.,
EnviroSystem Div. 48 p.

72-5       Life cycle fish

40791301	McAllister, W. (1988) Full Life Cycle Toxicity of Carbon
14|-FMC 54800 to Fathead Minnow (Pimephales promelas) in a Flow-through
System: ABC Final Report No. 34843. Unpublished study prepared by
Analytical Bio-Chemistry Laboratories, Inc. 1922 p.

41032101	Palmieri, M. (1989) FMC Response to Ecological Effects Branch
Review Classification of the "Full Life Cycle Toxicity of Carbon14|-FMC
54800 to Fathead Minnow (Pimephales Promelas) in a Flow-through System".
Unpublished study. 17 p.

72-7       Simulated or Actual Field Testing

40981802	Akkari, K. (1985) Bifenthrin Pond Study - Analytical
Methodology, Storage Stability, and Pre-Test 1 Data: Proj. ID SG
182-85-10; P-1217. Unpublished study prepared by FMC Corp. 101 p.

40981803	Alvarez, M. (1988) Bifenthrin (FMC 54800) Aquatic (Pond) Study
- Drift Card Analysis: Proj. ID 182AF8760; P-1918. Unpublished study
prepared by FMC Corp. 61 p.

40981805	Akkari, K. (1988) Bifenthrin Pond Study - Magnitude of the
Residue of Bifenthrin in Pond Water: Proj. ID 182E55E01; P-1937.
Unpublished study prepared by FMC Corp. 65 p.

40981807	Akkari, K. (1988) Bifenthrin Pond Study - Storage Stability of
Bifenthrin in Field Fortified Samples: Proj. ID 182E55E01; P-1949.
Unpublished study prepared by FMC Corp. 72 p.

40981808	Akkari, K. (1988) Bifenthrin Pond Study - Magnitude of the
Residue of Bifenthrin in Pond Sediment: Proj. ID 182E55E01; P-1955.
Unpublished study prepared by FMC Corp. 70 p.

40981812	Ridler, J. (1988) Bifenthrin Pond Study - Magnitude of The
Residue of Bifenthrin in Biological Samples: Proj. ID 182E55E01; P-1976.
Unpublished study prepared by FMC Corp. 85 p.

40981813	Ridler, J. (1988) Analytical Method for the Determination of
Bifenthrin in Biological Samples: Project ID: 182E55E01. Unpublished
study prepared by FMC Corp. 46 p.

40981814	Akkari, K. (1988) Bifenthrin Pond Study--Magnitude of the
Residue of Bifenthrin in Sediment Bucket: Project ID: 182E55E01. Unpu-
blished study prepared by FMC Corp. 60 p.

40981815	Liu, D. (1988) Bifenthrin (FMC 54800) Aquatic (Pond)
Study--Aircraft Tank Mixture Analysis: Project ID: AF860038. Unpublished
study prepared by FMC Corp. 19 p.

40981816	ui, D. (1988) Bifenthrin Pond Study: Analytical Method for the
Determination of Bifenthrin in Aircraft Tank Mixture: Project ID:
AF860038. Unpublished study prepared by FMC Corp. 9 p.

40981817	Akkari, K. (1988) Bifenthrin Pond Study--Magnitude of the
Residue of Bifenthrin in Bioassay Water: Project ID: 182E55E01. Unpu-
blished study prepared by FMC Corp. 97 p.

40981818	Akkari, K. (1988) Bifenthrin Pond Study--Magnitude of the
Residue of Bifenthrin in Run-Off Water and Sediment: Project ID:
182E55E01. Unpublished study prepared by FMC Corp. 60 p.

40981819	Akkari, K. (1988) Bifenthrin Pond Study--Magnitude of the
Residue of Bifenthrin in Field Soil: Project ID: 182E55E01; 182E55E763.
Unpublished study prepared by FMC Corp. 72 p.

40981820	Akkari, K.; Javick, R. (1988) Bifenthrin Pond Study: Analytical
Method for the Determination of Bifenthrin in Soil: Project IDs:
182AF8763; 182E55E01. Unpublished study prepared by FMC Corp. 46 p.

40981821	Giddings, J. (1988) FMC 54800 Aquatic Effects Field Study:
Phase I Baseline Ecological Survey of Hagan's Pond Orrville, Alabama:
Project ID:Report BW-86-7-2082; Study No. 282-6110-000. Unpublished
study prepared by Springborn Life Sciences, Inc. 600 p.

40981822	Sherman, J. (1989) Bifenthrin Pond Study: Ecological Effects
During Treatment and Post-Treatment Follow-up Studies of Hagan's Pond,
Orville, Alabama: Project ID: A84-1285-02; FMC/54800. Unpu- blished
study prepared by The Academy of Natural Sciences of Philadelphia. 1037
p.

81-1       Acute oral toxicity in rats

132519	Norvell, M.; Freeman, C. (1983) Acute Oral Toxicity of FMC 54800
Technical in Rats: Study #A83-859. (Unpublished study received Nov 3,
1983 under 279-EX-101; submitted by FMC Corp., Philadel- phia, PA;
CDL:251726-A)

132527	DeProspo, J.; Freeman, C. (1983) Acute Oral Toxicity of 54800,
2EC in Rats: Study #A83-1027. (Unpublished study received Nov 3, 1983
under 279-EX-101; submitted by FMC Corp., Philadelphia, PA;
CDL:251726-I)

141187	Freeman, C. (1984) Acute Oral Toxicity of FMC 54800 10 WP in
Rats: Study Number A84-1268. Unpublished study prepared by FMC Toxi-
cology Laboratory. 54 p.

155285	Freeman, C. (1983) Acute Oral Toxicity of FMC 54800, 100 g/l EC
in Rats: Study Number A83-1054. Unpublished study prepared by FMC Corp.
61 p.

40383605	Freeman, C. (1987) Acute Oral Toxicity Study in Rats: FMC
102032 Tech.: Study No. A87-2314. Unpublished study prepared by FMC
Corp. 15 p.

40637602	Gabriel, D. (1987) 1.0% Talstar, Aerosol Concentrate,: Acute
Oral Toxicity, Single Level - Rats: Proj. No. 87-5835A. Unpub- lished
study prepared by Biosearch Inc. 9 p.

41150202	Gabriel, D. (1989) PT 1800DS, Aerosol Concentrate, Form
#62-002: WRL Project #35-014: Acute Oral Toxicity, Single Level - Rats:
Biosearch Project No. 89-6589A. Unpublished study prepared by Biosearch
Inc. 8 p.

41413602	DeProspo, J. (1984) FMC 54800 80 G/L Flowable: Acute Oral
Toxicity in Rats: Study No. A84-1247. Unpublished study prepared by FMC
Toxicology Laboratory. 51 p.

41539002	Freeman, C. (1987) Acute Oral Toxicity Study in Rats: Capture 2
EC: Lab Project Number: A87-2410. Unpublished study prepared by FMC
Toxicology Laboratory. 26 p.

41744301	Freeman, C. (1990) Acute Oral Toxicity Study in Rats: FMC 54800
1 EC: Lab Project Number: A90-3234. Unpublished study prepared by FMC
Corp. 25 p.

41968506	Freeman, C. (1990) Acute Oral Toxicity Study in Rats: FMC 78161
Technical: Lab Project Number: A90-3173. Unpublished study pre- pared by
FMC Corp. 24 p.

41968513	Freeman, C. (1990) Acute Oral Toxicity Study in Rats: FMC 78162
Technical: Lab Project Number: A90-3172. Unpublished study pre- pared by
FMC Corp. 24 p.

42023302	Freeman, C. (1991) Bifenthrin 5% Tablet Blend: Acute Oral
Toxicity Study in Rats: Lab Project Number: A91-3412. Unpublished study
prepared by FMC Corp. 27 p.

42094202	Freeman, C. (1990) Bifenthrin 0.2% Granules: Acute Oral
Toxicity Study in Rats: Lab Project Number: A90-3157. Unpublished study
prepared by FMC Corp. Toxicology Lab. 14 p.

42231802	Freeman, C. (1991) Acute Oral Toxicity Study in Rats: Lab
Project Number: A91-3473. Unpublished study prepared by FMC Corp. 22 p.

42376102	Gabriel, D. (1992) Acute Oral Toxicity, LD50--Rats: PT 1810
Concentrate Less Propellant|: Lab Project Number: 91-7460A: 35-43.
Unpublished study prepared by Biosearch Inc. 18 p.

43758101	Freeman, C. (1994) FMC 54800 0.3% ME: Acute Oral Toxicity Study
in Rats: Revised Report: Lab Project Number: A90-3300. Unpublished study
prepared by FMC Corp. 20 p.

43758402	Freeman, C. (1995) FMC 54800 13% MUP: Acute Oral Toxicity Study
in Rats: Lab Project Numbers: A94-4124: ATM-0214: 307. Unpublished study
prepared by FMC Corp. 44 p.

43780502	Freeman, C. (1995) FMC 54800 0.2G: Acute Oral Toxicity Study in
Rats: Lab Project Number: A95/4138. Unpublished study prepared by FMC
Corp. 38 p.

43782102	Freeman, C. (1995) FMC 54800 0.2% G (Fertilizer): Acute Oral
Toxicity Study in Rats: Lab Project Numbers: A95-4148: ATM-0229.
Unpublished study prepared by FMC Corp. 37 p.

44368201	Freeman, C. (1997) Acute Oral Toxicity Study in Rats: FMC 54800
2EC: Lab Project Number: A96-4546: 26. Unpublished study prepared by FMC
Corp. 65 p.

44418201	Hoffman, G. (1996) Acute Oral Toxicity Study with PT-1820
Talstar T.R. in Rats: Lab Project Number: 95-1316. Unpublished study
prepared by Huntingdon Life Sciences. 39 p.

44657101	Freeman, C. (1998) Acute Oral Toxicity Study in Rats: FMC 54800
IF: Lab Project Number: A97-4772. Unpublished study prepared by FMC
Corporation. 43 p.

44869002	Freeman, C. (1998) FMC 54800 2.4% ME: Acute Oral Toxicity Study
in Rats: Lab Project Number: A38-4879. Unpublished study prepared by FMC
Corporation. 31 p.

45353602	Freeman, C.; Scubelek, S. (2001) Acute Oral Toxicity Study in
Rats: Bifenthrin 1.15 G: Lab Project Number: A20000-5290. Unpublished
study prepared by FMC Corporation. 21 p. {OPPTS 870.1100}

45364902	Allen, D. (1995) Semafor 20 FS: Acute Oral Toxicity Test in the
Rat: Lab Project Number: 240/125: A2001-5348. Unpublished study prepared
by Safepharm Labs., Ltd. 34 p.

45654404	Tiwari, V. (2002) Acute Oral Toxicity Study of Bifenthrin
Technical in Rats: Final Report: Lab Project Number: 3415. Unpublished
study prepared by Jai Research Foundation. 33 p.

45730302	Kuhn, J. (2002) Acute Oral Toxicity Study in Rats:
Bifenthrin/Spinosad 240 g/l SC: Final Report: Lab Project Number:
A2002-5548: 7025-02. Unpublished study prepared by Stillmeadow, Inc. 22
p. {OPPTS 870.1100}

46425301	H.R. Mclane, Inc. (2004) Restricted Use Product: Control XX-X-X
Turf Fertilizer with 0.069% Bifenthrin Insecticide. Project Number:
EPA/CSI/BIFENR69/PC1. Unpublished study. 7 p.

46431902	Wright, J. (2004) Talstar 2% MB Insecticide Acute Toxicology
Waiver Request. Project Number: 04/PRA/104. Unpublished study prepared
by Product & Regulatory Associates, L.L.C. 14 p.

46778504	Wright, J. (2006) NUP Granule Insecticide: Acute Toxicity
Waiver Request. Project Number: 06/PRA/119. Unpublished study prepared
by Product & Regulatory Associates, LLC. 11 p.

46795910	Wright, J. (2006) NUP Fertilizer Insecticide: Acute Toxicology
Waiver Request. Project Number: 06/PRA/121. Unpublished study prepared
by Product & Regulatory Associates, LLC. 10 p.

123-2           Aquatic plant growth

45020014	Hoagland, K.; Drenner, R.; Smith, J. et al. (1992) Freshwater
Community Responses to Mixtures of Agricultural Pesticides: Effects of
Atrazine and Bifenthrin. Environmental Toxicology and Chemistry
12:627-637.

850.1790       Chironomid Sediment Toxicity Test

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

141-1 	Bee/Non-target Insect Toxicity

163096	FMC Corp. (1986) Hazard Evaluation: Wildlife & Aquatic Organisms:
Bifenthrin Tech. Insecticide/Miticide. Unpublished compilation. 60 p.

163104	FMC Corp. (1986) Nontarget Insects [Toxicity of Residues on
Foliage]: Bifenthrin Tech. Unpublished compilation. 45 p.

44396503	Giddings, J. (1997) Aquatic Mesocosm and Field Studies with
Cotton Pyrethroids: Observed Effects and Their Ecological Significance:
Lab Project Number: 97-6-7014: 13656.0497.6100.900. Unpublished study
prepared by Springborn Labs., Inc. 102 p.

Appendix A.   PRD data request justification tables

The following proposed Data Call-in tables include rationales for
requiring the data requested in this problem formulation, explanations
of the utility of the data, and explanations for how the data might
impact risk assessment, following the format provided by PRD.

Guideline Number: 835.2120

Study Title:  Hydrolysis

Guideline Number: 835.2240

Study Title:  Aqueous Photolysis

Rationale for Requiring the Data

According to 40 CFR Part 158, Subpart N (Environmental Fate) §158.1300
(Environmental fate data requirements table), these data are required
for all terrestrial use patterns.

The available hydrolysis study was performed in the presence of high
levels of the cosolvent acetonitrile (around 7%) and at high
concentrations (0.5 and 5.2 ppm vs. the solubility of bifenthrin, which
is 0.014 ppb).  There was evidence of precipitation.  It is unknown if
the presence of the cosolvent or the high concentration of the test
substance could have affected the study results.

The available aqueous photolysis study was also performed in the
presence of high levels of cosolvent acetonitrile (around 30%).  Also,
the samples were not buffered and the studies were performed at above
the solubility limit (at 1 ppm vs. the solubility of 0.014 ppb).  The
study indicates that bifenthrin was stable to aqueous photolysis in
natural sunlight.  It is unknown if the presence of the cosolvent could
have affected the study results.  In the same study, using artificial
light, bifenthrin degraded with a reported half-life of 11.9 days and in
sensitized (acetone) solution it was 0.31 days.  There is a high level
of uncertainty with respect to the levels of photolysis (rate of
reaction), and the possible transformation products.

Practical Utility of the Data

How will the data be used?

Bifenthrin is a synthetic pyrethroid with high toxicity towards aquatic
organisms, including those living in the benthos.  Knowledge of its
persistence in aquatic environments is important.  The results of this
study will be used in the environmental fate assessment, and later on,
in the ecological risk characterization.

In addition, the data will be used to derive the rate of reaction input
parameters to be used in the aquatic models GENEEC2, PRZM/ EXAMS and
FIRST.  The results from these models are used to determine exposure
concentrations in aquatic systems, for ecological risk estimation and to
determine surface drinking waters concentrations, in drinking water
exposure assessments.

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

Without these data, the Agency would have to make certain conservative
assumptions (e.g. assume that bifenthrin is stable to these processes in
the aquatic models).  These conservative assumptions could lead to
higher predicted concentrations (EECs), according to the models, and
consequently, higher risk quotients.  Also, there would be a higher
degree of uncertainty in the environmental fate assessment.  Knowledge
of these dissipation pathways in detail is essential to perform a better
and accurate environmental fate assessment and risk assessment.

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 bifenthrin that may be
unnecessary.

Guideline Number: 835.4100

Study Title:  Aerobic Soil Metabolism

Guideline Number: 835.4200

Study Title:  Anaerobic Soil Metabolism

Rationale for Requiring the Data

According to 40 CFR Part 158, Subpart N (Environmental Fate) §158.1300
(Environmental fate data requirements table), these data are required
for all terrestrial use patterns.

For aerobic soil metabolism, there are studies available with three
soils.  A study performed in one additional soil should be submitted.
According to OPPTS Guideline 835.4100 & 835.4200, studies are required
in a total of four soils.  The registrant should monitor the volatiles,
which were not monitored in the previous studies, and there is
uncertainty about their relevance

The available anaerobic soil metabolism study was performed with only
one soil and for a period of roughly 2 months of anaerobic incubation.
Anaerobic studies with one soil type are generally sufficient for the
evaluation of transformation pathways.  Rates of transformation should
be determined in at least three additional soils.  Data performed for a
longer period of time will help the Agency to determine rates of
transformation and presence of possible metabolites.  The volatiles
should be monitored, since there is uncertainty about their relevance.

Practical Utility of the Data

How will the data be used?

Bifenthrin is a synthetic pyrethroid with high toxicity towards aquatic
organisms, including those living in the benthos.  Knowledge of its
persistence in terrestrial and aquatic environments is important.  The
results of this study will be used in the environmental fate assessment,
and later on, in the ecological risk characterization.

In addition, the data will be used to derive the rate of reaction input
parameter to be used in the aquatic models GENEEC2, PRZM/ EXAMS and
FIRST.  The results from these models are used to determine exposure
concentrations, for ecological risk estimation, and to determine surface
drinking water concentrations, for drinking water exposure assessments.

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

Without these data, the Agency would have to make certain conservative
assumptions (e.g. use a two times the aerobic soil metabolism half-life
input for the aerobic aquatic metabolism or two times the anaerobic soil
metabolism half-life for the anaerobic aquatic metabolism in the aquatic
models).  These conservative assumptions could lead to higher predicted
concentrations (EECs), according to the models, and consequently, higher
risk quotients.  Also, there would be a higher degree of uncertainty in
the environmental fate assessment.  Knowledge of these dissipation
pathways in detail is essential to perform a better and accurate
environmental fate assessment and risk assessment.

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 bifenthrin that may be
unnecessary.

Guideline Number: 835.4300

Study Title:  Aerobic Aquatic Metabolism

Guideline Number: 835.4400

Study Title:  Anaerobic Aquatic Metabolism

Rationale for Requiring the Data

According to 40 CFR Part 158, Subpart N (Environmental Fate) §158.1300
(Environmental fate data requirements table), these data are required
for all terrestrial use patterns.

There are no aerobic or anaerobic aquatic metabolism studies available
for review.

Practical Utility of the Data

How will the data be used?

Bifenthrin is a synthetic pyrethroid with high toxicity towards aquatic
organisms, including those living in the benthos.  Knowledge of its
persistence in soil and aquatic environments is important.  The results
of this study will be used in the environmental fate assessment, and
later on, in the ecological risk characterization.

In addition, the data will be used to derive the rate of reaction input
parameter to be used in the aquatic models GENEEC2, PRZM/ EXAMS and
FIRST.  The results from these models are used for ecological risk
estimation and in drinking water exposure assessments.

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

Without these data, the Agency would have to make certain conservative
assumptions (e.g. use two times the aerobic soil metabolism half-life
input for the aerobic aquatic metabolism or two times the anaerobic soil
metabolism half-life for the anaerobic aquatic metabolism in the aquatic
models).  These conservative assumptions could lead to higher predicted
concentrations (EECs), according to the models, and consequently, higher
risk quotients.  Also, there would be a higher degree of uncertainty in
the environmental fate assessment.  Knowledge of these dissipation
pathways in detail is essential to perform a better and accurate
environmental fate assessment and risk assessment.

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 bifenthrin that may be
unnecessary.

Guideline Number: 835.1230

Study Title:  Mobility – Adsorption/ Desorption

Rationale for Requiring the Data

According to 40 CFR Part 158, Subpart N (Environmental Fate) §158.1300
(Environmental fate data requirements table), this data is required for
all terrestrial use patterns.

The available study was performed at a single concentration and no
Freundlich correlations are available.  Also, the solutions contained
acetonitrile as cosolvent (2%) this could have affected the results.
The study indicated that bifenthrin is immobile in the soils tested (KOC
≥ 100,000; FAO Mobility Classification).  The mobility of this
chemical may be greatly under or overestimated and is uncertain.

Practical Utility of the Data

How will the data be used?

Bifenthrin is a synthetic pyrethroid with high toxicity towards aquatic
organisms, including those living in the benthos.  Knowledge of its
mobility in soil environments and its organic carbon normalized
adsorption coefficient is important.  The results of this study will be
used in the environmental fate assessment, and later on, in the
ecological risk characterization.

In addition, the data will be used to derive the mobility input
parameter to be used in the aquatic models GENEEC2, PRZM/ EXAMS, FIRST
and SCI-GROW.  The results from these models are used for ecological
risk estimation and in drinking water exposure assessments.

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

Without these data, the Agency would have to make certain uncertain
assumptions (e.g. use the adsorption constants derived at the highest
concentration only for the mobility input parameter in the aquatic
models).  These uncertain assumptions could lead to higher predicted
concentrations (EECs), according to the models, and consequently, higher
risk quotients.  The KOC input parameter has a major effect in the
determination of the EECs for benthic organisms.  Also, there would be a
higher degree of uncertainty in the environmental fate assessment.
Knowledge of the mobility of this chemical in detail is essential to
perform a better and accurate environmental fate and risk assessment.

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 this chemical that may be
unnecessary.

Guideline Number: None

Study Title:   Environmental Chemistry Methods (ECM) and Independent
Laboratory Validation (ILV) for Soil, Water and Sediment

Rationale for Requiring the Data

According to the data requirements in 40 CFR Part 158, ECMs are
currently required along with successful confirmatory method trials
(validation) by an independent laboratory (i.e. ILVs).  In addition to
the method for soil, at this time, methods are required for water and
sediment.  Acceptable ECMs for the residues of concern (parent and its
transformation products, if applicable) should have levels of
quantization that are adequate to address risk concerns or that are at
levels below the toxicological endpoints for the relevant aquatic
organisms.  The results of previous assessments indicate that there is
risk for freshwater and estuarine/ marine fish, invertebrates and
benthic organisms.  Therefore, ECMs for water and sediment are required
in addition to the ECM for soil.  The ECMs should include parent and
those residues found in the laboratory studies that exceed 10% of the
applied. The registrant is encouraged to submit state-of-the-art
environmental chemistry methods; further, multi-residue methods (MRMs)
for soil, water and sediment are preferred, if applicable.

Practical Utility of the Data

How will the data be used?

The data will be used to verify the suitability of the methods.
Subsequently the methods could be used by states or other enforcement
agencies, departments or entities, to monitor concentrations of the
residues of concern.  Validated analytical methods in environmental
media (a.k.a., ECMs) are useful for conducting and evaluating submitted
environmental fate and toxicity field and monitoring studies and for
addressing potential risks to the environment posed by the use and/or
accidental release of pesticides.

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

If monitoring of the chemical is required or performed, the Agency could
be able to determine if the chemical is present in the environment at
concentrations that are threatening to wildlife (or to humans, in the
case of drinking waters), according to the levels of concern (LOCs).  If
that is the case, measures to prevent these concentrations to occur
could be taken.  The data could also be used by enforcement entities
like the states or government agencies or departments.  Without these
data, the potential for the determination of residues of bifenthrin and
transformation products (if applicable) in soil, water and sediment is
restricted.  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
bifenthrin which may otherwise be avoided, or which are unnecessarily
severe.

Guideline Number: None

Study Title: POTW Effluent Monitoring and POTW Treatability Study

Rationale for Requiring the Data

POTW Effluent Monitoring – Request any existing or ongoing POTW
effluent monitoring data for the pyrethroids be submitted to the Agency.

POTW Treatability Study – The Agency has recently requested and
provided comments on a protocol developed by the Pyrethroid Working
Group (PWG) for a bench scale study of waste water treatment, to assess
the percentage removed in the biosolids by the treatment, the amount
that would degrade during treatment, and the amount that would remain in
the waste water.   These data would be used to inform removal
percentages by waste water treatment, which is an input to the Exposure
and Fate Assessment Screening Tool’s (E-FAST) down-the-drain module.
The Office of Pesticide Programs will continue to confer with the Office
of Water with the goal of refining our down-the-drain assessment for
registration review. It is the responsibility of the registrant to
ensure that bifenthrin is included in the study completed by the PWG or
conduct a similar study on their own (following submission of a protocol
for review).

Practical Utility of the Data

How will the data be used?

These data would be used to inform removal percentages by waste water
treatment, which is an input to the Exposure and Fate Assessment
Screening Tool’s (E-FAST) down-the-drain module.

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

Without these data, the Agency will have to make assumptions regarding
the level of removal of bifenthrin (e.g., results of modeling from the
EPIWEB v.4.0 may be used).  Since the assumptions are likely to be crude
and conservative.  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
bifenthrin which may otherwise be avoided, or which are unnecessarily
severe.

Guideline Number: 850-2100

Study Title:  Passerine Acute Avian Oral

Rationale for Requiring the Data

Although an acute avian oral study was received for both the Mallard
duck and the Bobwhite quail, the Agency updated its data requirements in
40 CFR Part 158 (October 26, 2007) to include an acute oral toxicity
study for both a passerine species and either a waterfowl or an upland
game species.  Prior to starting toxicity testing, a protocol will need
to be provided for review.

Many passerine species utilize agricultural fields, forests, residential
areas and surrounding areas, and, therefore, have the potential to be
exposed to pesticides used in agricultural, forest, and residential
settings

It is likely that, for most pesticide use patterns, passerines are more
likely to be exposed to pesticides than upland game species and
waterfowl

Passerines are smaller and have faster metabolisms than the waterfowl
and upland game bird species traditionally used in avian toxicity tests
which could impact their sensitivity to chemicals.

Practical Utility of the Data

How will the data be used?

Data from passerine toxicity studies will be used to estimate potential
risks to birds associated with uses of bifenthrin.  The data will reduce
uncertainties associated with the current risk assessment for passerine
species and will improve our understanding of the potential effects of
bifenthrin.

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

Because birds significantly contribute to overall environmental quality,
a solid understanding of the potential risks to birds, including
passerine species, is essential for sound environmental management.
Without acceptable data for bifenthrin, the Agency cannot determine the
levels of bifenthrin that result in effects to passerine species.  If
the data indicates that registered usage may pose a risk of adverse
effects to non-target birds above the Agency Level of Concern, the
Agency may explore decision options to mitigate this risk.  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 bifenthrin which may otherwise be avoided, or
which are unnecessarily severe.

Guideline Number:  850.1035

Study Title: Mysid Acute Toxicity (saltwater, Bifenthrin TEP only)

Rationale for Requiring the Data

Bifenthrin has the potential to enter estuarine/marine water bodies
based on current usage patterns that include coastal areas and the
expected environmental concentrations in aquatic environments reported
in previous Bifenthrin assessments. Bifenthrin technical is very highly
toxic to estuarine/marine invertebrates on an acute basis, but no
information has been submitted for the Bifenthrin TEP. A new study is
required based on the absence of acceptable data to satisfy the
guidelines for acute estuarine/marine fish and invertebrate studies with
the typical end-use product.

According to the Part 158 data requirements, testing on the typical
end-use product may be required for aquatic toxicity tests when any of
the following conditions exist:

	1.  The end-use product will be introduced directly into the aquatic
environment.

2.  The maximum expected environmental concentration or estimated
environmental concentration in the aquatic environment is greater than
or equal to one-half the LC50 or EC50 of the TGAI.

3.  An ingredient in the end-use formulation other than the active
ingredient is expected to enhance the toxicity of the active ingredient
or cause toxicity to aquatic organisms.

Previous assessments indicated that the expected environmental
concentrations of bifenthrin in aquatic environments were based on the
solubility limit in water (0.014 ppb). In freshwater and
estuarine/marine tests conducted with Bifenthrin technical, the most
toxic 96-hour LC50s were 0.15 µg/L for rainbow trout, 1.6 µg/L for
Daphnia, 17.5 µg/L for sheepshead minnow and 0.004 µg/L for Mysid
shrimp. Therefore, bifenthrin fulfills the second requirement for TEP
testing for estuarine/marine invertebrate species only.

Practical Utility of the Data

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

To address potential risks, the Agency imposed mitigation, as an interim
measure, which included reduced use rates and application restrictions.

How will the data be used?

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

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

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

Guideline Number:  850.1400

μg a.i./L) is below the 1.0 mg/L criterion specified in 40 CFR Part 158
for conditionally requiring this study.  Furthermore, the persistence of
bifenthrin in water is expected to substantially exceed the 4-d half
life criterion specified in 40 CFR Part 158.

Practical Utility of the Data

How will the data be used?

The estuarine/ marine fish early life stage study would allow the Agency
to analyze chronic effects, including effects on reproductive success
and growth, to saltwater species.  The effects data would be used to
determine the likelihood that the chronic risks can potentially impact
aquatic communities, either by direct effects on fish or by indirect
effects by reducing their food sources.  By refining the assessment, the
Agency would be able to determine whether the mitigation imposed as part
of the registration review process was appropriate due to toxicity
concerns with bifenthrin.

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

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

Guideline Number:  850.1500

Study Title:  Fish Full Life Cycle

Rationale for Requiring the Data

The full life cycle chronic toxicity of bifenthrin to fish is indicated
based on its aquatic toxicity and environmental fate properties per 40
CFR Part 158 data requirements (October 26, 2007). Specifically, a fish
full life cycle study may be conditionally required when the end use
product is expected transported to water from its intended use site, and
if any of the following apply:

1. The EEC is > 0.1 the NOEC from the fish ELS or invertebrate LC test,
or

2. Studies of other organisms indicate reproductive physiology in fish
may be affected.

For bifenthrin, 60-d EECs in surface water range from 0.017 to 0.10
µg/L based on a recent assessment of new uses on mayhew, soybean and
other crops (D336608; Meléndez and Federoff, 2007).  These EECs clearly
exceed 0.004 µg/L, which is one tenth of the fathead minnow ELS NOAEC
(i.e., 0.004 = 0.1 * 0.04 µg/L MRID 40791301) and the freshwater
invertebrate LC NOAEC (0.0013 µg/L; MRID 41156501).  Furthermore,
adverse effects were observed on Daphnia magna reproduction at 0.003
ug/L, which may indicate that similar reproductive effects are likely to
occur in fish.

Although a fish full life cycle study was previously submitted to the
Agency and classified as supplemental (MRID 40791301), a recent review
of this study revealed that it is unacceptable based on numerous
deficiencies identified in the study, such as low control survival and
an inadequate number of replicates (D381123; October 14, 2010).