Document ID: EPA-HQ-OPP-2009-0842-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-17T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

	

MEMORANDUM

  PC Code: 129013

  DP Barcode:  D365379

						December 15, 2009

SUBJECT:	Registration Review –Preliminary Problem Formulation for
Ecological Risk and Environmental Fate, Endangered Species, and Drinking
Water Assessments for Cyphenothrin 

TO:		Joy Schnackenbeck, Chemical Review Manager

		Robert McNally, Risk Manager

		Special Review and Reregistration Division (7509P)

FROM:	Brian Kiernan, Biologist

Cheryl Sutton, Ph.D., Environmental Scientist

		Environmental Risk Branch 4

		Environmental Fate and Effects Division (7507P)

		

REVIEWED

BY:		Marietta Echeverria, Risk Assessment Process Leader

		Thomas Steeger, Ph.D., Senior Biologist

Environmental Risk Branch 4

		Environmental Fate and Effects Division (7507P)

		

THROUGH:	Elizabeth Behl, Chief

		Environmental Risk Branch 4

		Environmental Fate and Effects Division (7507P)

		

The Environmental Fate and Effects Division (EFED) has completed the
preliminary problem formulation (attached) for the ecological risk,
environmental fate, endangered species, and drinking water assessments
to be conducted as part of the Registration Review of the pyrethroid
ether insecticide, cyphenothrin (PC Code 129013; DP Barcode D365379). 
The problem formulation draws on information from both open literature
and studies submitted by the technical registrants in response to data
requirements.  This document is intended to provide an overview of what
is currently known regarding the environmental fate and ecological
effects associated with cyphenothrin (CAS 39515-40-7) and its degradates
and outlines uncertainties regarding attributes of the parent compound
and its transformation products.  It describes the preliminary
ecological risk hypothesis and the processes that will be used during
the completion of the ecological risk assessment in support of
Registration Review.  This document also recommends studies that should
be included in a generic data call-in (DCI) to address uncertainties
surrounding the environmental fate and potential ecological effects of
cyphenothrin.

  SEQ CHAPTER \h \r 1 

				

Problem Formulation for the 

Environmental Fate and Ecological Risk 

and Endangered Species Assessments in Support of the Registration Review
of Cyphenothrin

Cyphenothrin (CAS 39515-40-7)

Prepared by:

Brian Kiernan, Biologist

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

Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch IV

1200 Pennsylvania Ave., NW

Mail Code 7507P

Washington, DC 20460

Reviewed by:

Marietta Echeverria, Risk Assessment Process Leader

Thomas Steeger, Ph.D., Senior Biologist

Elizabeth Behl, Branch Chief

	

 I.  Purpose

The purpose of this problem formulation is to provide an understanding
of the environmental fate and ecological effects of the registered uses
of cyphenothrin (PC Code 129013).  Cyphenothrin is a pyrethroid ester
insecticide used indoors (household/ domestic dwellings, storage areas,
pet living/sleeping quarters, ships and boats, processing plants).  An
environmental fate and ecological risk assessment would not be required
for the indoor uses.  Because there is a squeeze-on spot treatment for
dogs and horses, the possibility of surface water contamination will be
evaluated to account for the possibility of a treated animal entering
into a surface water body or being washed following treatment.  There is
a single outdoor use (Reg. No. 1021-1765) for aerosol spray application
to external doorways, window cracks and corners under porches and
patios, for which an environmental risk assessment is necessary.  This
document will provide a plan for analyzing data relevant to cyphenothrin
and for conducting environmental fate and ecological risk and endangered
species assessments for its registered outdoor uses.  Drinking water
exposure will not be assessed since a dietary risk assessment is not
going to be conducted.  Additionally, this problem formulation is
intended to identify data gaps, uncertainties, and potential assumptions
used to address those uncertainties, relative to characterizing the
ecological risk associated with the registered uses of cyphenothrin.  

II.  Problem Formulation

	A.  Nature of Regulatory Action

The Food Quality Protection Act of 1996 mandated the EPA to implement a
new program for assessing the risks of pesticides, i.e., Registration
Review (  HYPERLINK "http://www.epa.gov/oppsrrd1/registration_review/" 
http://www.epa.gov/oppsrrd1/registration_review/ ). All pesticides
distributed or sold in the United States generally must be registered by
EPA.  The decision to register a pesticide is based on the consideration
of scientific data and other factors showing that it will not cause
unreasonable risks to human health, workers, or the environment when
used as directed on product labeling.  The Registration Review program
is intended to ensure that, as the capability to assess risk evolves and
as policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects to human
health and the environment.  Because changes in science, public policy
and pesticide use practices will occur over time, the Agency will
periodically reevaluate pesticides to ensure that as change occurs,
products in the marketplace can continue to be used without unreasonable
risk. 

As part of the implementation of the Registration Review program,
pursuant to Section 3(g) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA), the Agency is conducting an environmental fate
and ecological risk assessment to determine whether cyphenothrin
continues to meet the FIFRA standard for registration.  This problem
formulation for the environmental fate and ecological risk assessment
chapter in support of Registration Review is intended for the initial
docket opening the public phase of the review process. 

B.  Conclusions from Previous Risk Assessments

The Agency has not previously conducted an ecological risk assessment or
a drinking water assessment for cyphenothrin since the chemical's use
was considered limited to indoors.  The registrant, Sumitomo Chemical
America, Inc, submitted an application for a manufacturing use
registration for cyphenothrin in 1985 and an application for the first
end-use product in 1987.  Registration was granted in 1991 (Reg. No.
10308-10).  The first squeeze on spot treatment was registered for use
on horses in 2005 (Reg. No. 002517-0084) and dogs in 2006 (Reg. No.
002517-0080).

III. Stressor Source and Distribution

A.  Mechanism of Action

Cyphenothrin, (RS)-α-cyano-3-phenoxybenzyl
(1RS)-cis-trans-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxyl
ate, belongs to the pyrethroid ester class of insecticides.  Its mode of
action involves inhibition of nerve impulse transmission by affecting
sodium channels. It is a non-systemic insecticide which has contact and
stomach action, with rapid knockdown (causes rapid paralysis that may be
reversible and that may or may not lead to death), and some repellent
properties.

Like many pyrethroids, cyphenothrin is formulated with a synergist. 
While not present in the squeeze-on spot treatments, the spray and
indoor fogger formulations contain the synergist N-octyl bicycloheptene
dicarboximide, also known as MKG-264
(http://www.epa.gov/pesticides/reregistration/REDs/mgk_red.pdf). 
Cyphenothrin is also often formulated with other pyrethroid
insecticides.

B.  Overview of Pesticide Usage

Currently, cyphenothrin is registered for spray and indoor fogger for
insect control, and squeeze-on spot treatment for dogs and horses.  The
outdoor use is for spray coverage (aerosol spray cans) of cracks around
doors and windows, and localized resting areas (e.g., under eaves), dark
corners under porches and patios.  Products labels indicate control of
spiders, ticks, fleas, beetles, ants, flies, midges, yellow jackets
(adult), small flying insects, cockroaches and other pests in domestic,
public health and industrial situations.  Available cyphenothrin use
information was obtained from the active labels in the Pesticide Product
Label System (PPLS; http://www.epa.gov/pesticides/pestlabels/).  Active
registration numbers were obtained from the Label Usage Information
System (LUIS) report.

C.  Environmental Fate and Transport

Cyphenothrin, a Type II pyrethroid, is a chrysanthemate ester
"first-generation" photolabile pyrethroid, according to an analysis
conducted by the California Department of Pesticide Regulation CDPR;
Spurlock & Lee, 2008).  In general, it is recognized that this class
(i.e., first-generation pyrethroids) of synthetic pyrethroid compounds
may photodegrade rapidly in sunlight (photolysis), with half-lives
generally on the order of hours (Spurlock & Lee, 2008).  Low water
solubility (hydrophobicity) is one of the distinguishing characteristics
of pyrethroid pesticides, which influences partitioning to sediment and
dissolved organic matter, and the bioavailability of these compounds.  

No environmental fate guideline studies have been submitted to EPA to
support the registration of cyphenothrin.  However, available
nonguideline data defining the physical, chemical, fate and transport
characteristics associated with cyphenothrin are summarized in Table 1. 
 These data were obtained from the product chemistry data (USEPA, 1986)
submitted by the registrant, and have been supplemented by with
information from the Pesticide Properties DataBase (PPDB) and the
Material Safety Data Sheet (MSDS; 7/6/09 update) for cyphenothrin.  

Table 1.  General physico-chemical and environmental fate properties of
cyphenothrin (no environmental fate guideline data submitted in support
of registration).

Chemical/Fate Parameter	Value(s)	Source	Comments

Molecular weight (MW) (g/mol)	375.47	Pesticide Properties DataBase
(PPDB)	PPDB 6 July 2009 update

Vapor pressure (VP) (20(C)	1.16 x 10-4 Pa

8.7 x 10-7 mmHg	Product Chemistry	2/19/86 EPA memo

Water solubility  (mg/L; at 25(C)	1.0	Product Chemistry	Prod. Chem. data
reported a range of 0.1-1.0 ppm.  2/19/86 EPA memo

Henry’s Law Constant (20(C)	1.85 X 10-03 (dimensionless)	--	--

Octanol-to-water partition coefficient (log KOW; 20(C) 	6.29	Product
Chemistry	2/19/86 EPA memo

Hydrolysis half-lives  (25(C) (days)	stable	PPDB	PPDB 6 July 2009 update

Soil photolysis half-life 

(days)	No data	--	--

Aqueous photolysis half-life (days)	No data	--	--

Aerobic soil metabolism half-life (days)	No data	--	--

Aerobic aquatic metabolism half-life (days)	No data	--	--

Anaerobic aquatic metabolism half-life (days)	No data	--	--

Soil partition coefficients (Kd)	No data	--	--

Organic-carbon normalized partition coefficients (Koc) (mL/goc)	9,224
PPDB	PPDB 6 July 2009 update

Fish bioconcentration factors (BCF)	No data	--	--

There are no data available on the bioconcentration/bioaccumulation
potential of cyphenothrin.  The reported logarithm of the octanol-water
partition coefficient (Log Kow) for cyphenothrin is 6.29, which
typically suggests a high potential for bioaccumulation.  A preliminary
analysis was conducted using the Agency’s PBT Profiler
(http://www.epa.gov/pbt/tools/toolbox.htm).  This model, based on
structural-activity relationships, indicates that cyphenothrin has
properties consistent with persistent bioaccumulative and toxic
compounds.  Additionally, the Agency’s ASTER model (Assessment Tools
for the Evaluation of Risk; http://www.epa.gov/med/Prods_Pubs/aster.htm)
provides an estimated BCF for cyphenothrin of 73,128X.  Given the lack
of environmental fate data specific to cyphenothrin, this estimate is
based primarily on the compound's log Kow.  The chrysanthemate moiety of
first-generation pyrethroids is known to be sensitive to
photodegradation (Spurlock and Lee 2008), and pyrethroids in general are
known to partition to organic matter rapidly.  Further, the degree to
which currently registered uses may result in long-term exposure is not
clear.  The potential for cyphenothrin to persist in the environment and
bioaccumulate in the food chain will be explored further in the risk
assessment. 

IV.  Receptors

Consistent with the process described in the Overview Document (USEPA
2004), the risk assessment for cyphenothrin will rely on a surrogate
species approach.  T  SEQ CHAPTER \h \r 1 oxicological data generated
from surrogate test species, which are intended to be representative of
broad taxonomic groups, are used to extrapolate to potential effects on
a variety of species (receptors) included under these taxonomic
groupings.  

Acute and chronic toxicity data from studies submitted by pesticide
registrants along with the available open literature will be used to
evaluate the potential direct and indirect effects of cyphenothrin on
aquatic and terrestrial receptors.  This includes toxicity data on the
technical grade active ingredient, degradates, and when available,
formulated products (e.g. “Six-Pack” studies).  Open literature
studies are identified using EPA’s ECOTOXicology database (ECOTOX)
(USEPA 2007b), which employs a literature search engine for locating
chemical toxicity data for aquatic life, terrestrial plants, and
wildlife.  The evaluation of these sources of data may also provide
insight into the direct and indirect effects of cyphenothrin on biotic
communities from loss of species that are sensitive to the chemical and
from changes in structure and functional characteristics of the affected
communities.  

Table 2 provides a summary of the taxonomic groups and the surrogate
species tested to characterize the potential acute and chronic
ecological effects of cyphenothrin.  In addition, the table provides a
preliminary overview of the potential acute toxicity of cyphenothrin by
providing the acute toxicity classifications.

A.  Effects to Aquatic Organisms

Technical grade cyphenothrin is classified as very highly toxic to
freshwater fish, aquatic-phase amphibians and freshwater aquatic
invertebrates on an acute exposure basis (Table 2).  No guideline
studies on acute exposure to estuarine/marine organisms have been
submitted.  Effects of chronic exposure to cyphenothrin on fish or
aquatic invertebrates have not been submitted to support risk
assessment.  No data on the effect of cyphenothrin on aquatic plants are
available.  In the absence of guideline toxicity studies or ECOTOX data
for cyphenothrin, the Agency will consider the potential for bridging
data from similar pyrethroids if such data is available.

Some aquatic  invertebrate species have been found to have greater
sensitivity to pyrethroids than Daphnia magna, the species typically
used in guideline toxicity studies submitted to EPA (Werner and Moran
2008).  To support their evaluation of pyrethroids, CDPR has requested
acute and chronic sediment toxicity data for the amphipod Hyallela
azteca and the benthic invertebrate midge, Chironomus spp., to address
potential aquatic risks
(http://www.cdpr.ca.gov/docs/registration/reevaluation/chemicals/summary
_ai_data_req.pdf ).  The Agency will make use of all available reliable
data in evaluating the potential risks associated with registered uses
of cyphenothrin.

B.  Effects to Terrestrial Organisms

Cyphenothrin is categorized as practically nontoxic to birds,
terrestrial-phase amphibians, and reptiles on a subacute dietary
exposure basis (Table 2); however, no effects data from acute oral
exposure are available.  Also, no data are available to evaluate the
effect of chronic exposure on avian species or their surrogates.  Data
reviewed by the Health Effects Division (HED) show cyphenothrin to be
moderately toxic to mammals on an acute oral exposure basis.  Limited
information is available regarding the effects of chronic exposure to
mammals.  No data are available on the potential effect of cyphenothrin
exposure on honeybees although as an insecticide adverse effects should
be expected on beneficial as well as target insects.  No data are
available with which to evaluate the toxicity of cyphenothrin to
terrestrial plants.  However, there several incidents of phytotoxicity
associated with permethrin (PC Code 109701), a similarly-structured
pyrethroid, reported in the Environmental Incident Information System
(EIIS) database.

Table 2.  Test Species Evaluated for Assessing Potential Ecological
Effects of Cyphenothrin and the Associated Acute Toxicity
Classification. NA=data not available.

Taxonomic Group	Surrogate Species	Acute Toxicity

	Citation

MRID	Acute Toxicity Classification*

Chronic Toxicity

Birds1	  SEQ CHAPTER \h \r 1 Bobwhite quail (Colinus virginianus)	LD50 =
NA

LC50>5,600 mg/kg diet	--

40983601	Practically nontoxic

NOAEC = NA

LOAEC = NA	---

---

	*

  SEQ CHAPTER \h \r 1 Mammals	  SEQ CHAPTER \h \r 1 Laboratory rat
(Rattus norvegicus)	LD50 =318 mg/kg	42436212	Moderately toxic

NOAEC =NA

LOAEC =NA	--

--	

*

  SEQ CHAPTER \h \r 1 Insects	  SEQ CHAPTER \h \r 1 Honey bee (Apis
mellifera L.)	NA	--	--

  SEQ CHAPTER \h \r 1 Terrestrial plants3	 	NA	NA	NA

  SEQ CHAPTER \h \r 1 Freshwater fish2	Rainbow trout (Oncorhynchus
mykiss)	96-hour LC50 = 0.34 µg/L	41087502	Very highly toxic

NOAEC = NA

LOAEC = NA	--

--	*

  SEQ CHAPTER \h \r 1 Freshwater invertebrates	  SEQ CHAPTER \h \r 1
Water flea

(Daphnia magna)	48-hour EC50 = 0.43 µg/L	41087501	Very highly toxic

NOAEC = NA

LOAEC =NA	--

--	*

  SEQ CHAPTER \h \r 1 Estuarine/marine fish

NA	NA	NA

Estuarine/marine invertebrates

NA	NA	NA

  SEQ CHAPTER \h \r 1 Aquatic plants 

NA	NA	NA

* Chronic Toxicity is not classified

  SEQ CHAPTER \h \r 1 1 Birds represent surrogates for terrestrial-phase
amphibians and reptiles.

2 Freshwater fish may be surrogates for aquatic-phase amphibians.

3 Four species of two families of monocots (one is corn); six species of
at least four dicot families (one is soybeans).

C.  Degradate toxicity

There are currently no available data on the degradation of
cyphenothrin.  

D.  Ecological Incidents 

A preliminary review of the Ecological Incident Information System
(EIIS; 2007a)) maintained by the Agency’s Office of Pesticide Programs
(OPP) indicates no incidents have been reported as of 07/22/2009. 
However, there are several incidents of phytotoxicity associated with
permethrin (PC Code 109701), a similarly-structured pyrethroid. 
Additionally, the lack of reported incidents cannot be construed as the
lack of incidents.  Since 1998, registrants are only required to submit
detailed information to EPA on 'major' incidents (for example, affecting
>200 flocking birds).  Minor incidents are aggregated and are not
included in EIIS due to the lack of detail provided.  In addition, there
have been changes in state monitoring efforts due to lack of resources. 

A search on 8/15/09 of the Avian Incident Monitoring System (AIMS; 
http://www.abcbirds.org/abcprograms/policy/pesticides/aims/aims/index.cf
m) maintained by the American Bird Conservancy, did not reveal any
incidents involving cyphenothrin and birds.

Reported pet incidents involving the use of cyphenothrin, from
10/2007-8/2009, include 71 mortalities, 73 major incidents, 2674
moderate incidents and 13,373 minor incidents.  These numbers represent
incidents from all pet pesticide products, including shampoos. 
Cyphenothrin products account for 10% of the total reported pet
mortalities, 13% of all major incidents, 54% of all moderate incidents
and 65% of minor incidents.  These data are for cyphenothrin
co-formulated with pyriproxifen (CAS 95737-68-1), and it is unclear
whether one active or the other, or an emergent effect from the
formulation is responsible for these incidents.

 Ecosystems Potentially at Risk

The ecosystems potentially at risk are often extensive in scope;
therefore, it may not be possible to identify specific ecosystems during
the development of a nation-wide ecological risk assessment.  Outdoor
uses of cyphenothrin are labeled for outside surfaces of window and door
frames, as well as dark corners and localized resting areas such as
under eaves), porches, patios and garages.  However, in general terms,
terrestrial ecosystems potentially at risk could include areas
immediately adjacent to treated structures and areas that may receive
drift or runoff.  Areas adjacent to the aerosol can spray treated areas
could include lawns, ornamental plantings, stream and pond edges.  

Aquatic ecosystems potentially at risk include water bodies adjacent to,
or downstream from, the aerosol can spray treated areas and might
include impounded bodies such as ponds, lakes and reservoirs, or flowing
waterways such as streams or rivers.  In coastal areas, aquatic habitat
also includes estuarine areas.  Wash-off from treated dogs and horses
may result in surface water contamination, either through the animal’s
immersion in the waterbody or as a result of washing pets that have been
treated.

V.  Assessment Endpoints

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

Assessment endpoints for cyphenothrin, as well as all pesticides
evaluated for ecological risk, include potential direct toxic effects on
the survival, reproduction, and growth of the receptors, as well as
indirect effects, such as reduction of the prey base or modification of
habitat.  Each assessment endpoint requires one or more “measures of
ecological effect,” defined as changes in the attributes of an
assessment endpoint or changes in a surrogate entity or attribute in
response to exposure to a pesticide.  Specific measures of ecological
effect are generally evaluated based on acute and chronic toxicity
information from registrant-submitted guideline tests that are performed
on a limited number of organisms.  Additional ecological effects data
from the open literature will also be considered.  Currently available
ECOTOX references are presented in Appendix 1.

VI. Conceptual Model

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

The conceptual model for cyphenothrin provides a written description and
visual representation of the predicted relationships between
cyphenothrin, potential routes of exposure, and the predicted effects
for the assessment endpoint.  The conceptual model consists of two major
components: risk hypothesis and a conceptual diagram (USEPA 1998).

A.  Risk Hypothesis

A risk hypothesis describes the predicted relationship among the
stressor, receptor exposure, and assessment endpoint response along with
the rationale for their selection.  For cyphenothrin, the following
ecological risk hypothesis will be employed for the national-level
ecological risk assessment:

Cyphenothrin, when used as a squeeze-on spot treatment for dogs or
horses, or used on outdoor surfaces, in accordance with current labels,
may result in off-site movement of the compound via wash-off (from
pets), runoff, erosion of sediment-bound residues or spray drift leading
to exposure of nontarget plants and animals.  These potential exposure
pathways may result in adverse effects upon the survival, growth, and/or
reproduction of non-target terrestrial and aquatic organisms.  These
nontarget organisms may include Federally-listed threatened and
endangered species.

B.  Conceptual Diagram

The known and/or estimated environmental fate properties of cyphenothrin
indicate that pet wash-off, runoff, erosion of sediment-bound residues
and spray drift represent possible transport mechanisms of cyphenothrin
to aquatic and terrestrial environments.  Given the labeled outdoor uses
of cyphenothrin (which generally limit application to outside treatment
of structures), and the directions for squeeze-on spot treatments (which
state treated animals should not be washed immediately after treatment
unless adverse reaction is observed), the likelihood and magnitude of
residue transport and receptor exposure is likely limited but remains
uncertain.  Still, because there is an outdoor residential use and a pet
spot treatment use, exposure remains possible.  The transport mechanisms
(e.g. sources) are depicted in the conceptual models below (Figures 1, 2
and 3) and result in the movement of cyphenothrin into aquatic (water
and sediment) and terrestrial (soil and foliage) habitats.  The movement
away from the site of application in turn represents exposure pathways
for a broad range of biological receptors of concern and the potential
attribute changes, i.e., effects such as reduced survival, growth and
reproduction, in the receptors due to cyphenothrin exposure. 

 

Figure   SEQ Figure \* ARABIC  1 . Conceptual model for potential risks
of cyphenothrin to aquatic organisms.  Dotted lines indicate exposure
pathways that have a low likelihood of contributing to ecological risk.

 

 

Figure   SEQ Figure \* ARABIC  2 .  Conceptual model for potential risks
of cyphenothrin to terrestrial organisms.  Given the limited outdoor
uses, no effort has been made to identify a single predominant route of
terrestrial exposure in this diagram.

 

Figure 3.  Conceptual model for potential risks of cyphenothrin to
aquatic organisms a result of the spot treatment for pets.

VII.  Analysis Plan 

In order to address the risk hypothesis, the potential for adverse
effects on the environment will be estimated.  The use, environmental
fate, and ecological effects of cyphenothrin will be characterized and
integrated to estimate risk.  For screening-level assessments, 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 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 cyphenothrin may be estimated using a
probit dose-response slope and either the level of concern (discussed
below) or actual calculated risk quotient value.

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

A.  Stressors of Concern

The stressor of concern in the assessment will be the parent compound
(cyphenothrin).  There are no available guideline data on the
environmental fate of cyphenothrin or degradates that may form; fate
data are being requested.  If degradates of concern are identified, they
will be considered in the risk assessment.  Potentially toxic
contaminants resulting from the manufacturing process and present in the
formulated pesticide will also be considered.

The cyphenothrin aerosol spray, which is registered for residential
outdoor use, is formulated with the synergist N-octyl bicycloheptene
dicarboximide, also known as MKG-264.  According to the Registration
Eligibility Decision (RED) for MKG-264
(http://www.epa.gov/pesticides/reregistration/REDs/mgk_red.pdf), MKG-264
is moderately toxic to aquatic animals from acute exposure.  However,
the RED modeled exposure from agricultural uses of MKG-264, at higher
concentrations than are expected from the labeled outdoor use of the
cyphenothrin aerosol spray.  However, the presence of a synergist may
result in greater sensitivity to the formulated product than is
indicated by guideline studies on the technical product.

Evaluation of pesticide active ingredient mixtures is beyond the scope
of this assessment because of the myriad factors that cannot be
quantified based on the available data.  Those factors include
identification of other possible co-formulations and their
concentrations, differences in the pattern and duration of exposure
among contaminants, and the differential effects of other
physical/chemical characteristics of the receiving waters (e.g. organic
matter present in sediment and suspended water).  Evaluation of factors
that could influence additive/synergistic effects is beyond the scope of
the assessment.  However, the Agency acknowledges that not considering
mixtures could over- or under-estimate risks depending on the type of
interaction and factors discussed above.  The assessment will, however,
consider the toxicity of formulated products (including formulations
involving more than one active ingredient) and will determine whether
formulated products are more toxic than the technical grade active
ingredient data used for assessing both direct and indirect risks.

B.  Measures of Exposure 

Agency measures of exposure are typically based on terrestrial and
aquatic models that estimate environmental concentrations of the
chemical being assessed using labeled application rates and methods for
large-scale uses (e.g., agricultural and public health uses).  These
models require environmental fate data as input.  However, because the
outdoor uses assessed here are limited to small-scale, residential uses,
exposure will be estimated to the best degree possible based on
potential cyphenothrin use patterns, known or estimated chemical
properties (e.g.,  rapid photodegradation and hydrolytic stability), and
toxicity.  There are no monitoring data for cyphenothrin.

For outdoor urban uses in general, it is assumed that runoff water from
rain and/or lawn watering may move pesticide directly to surface water
or to storm sewers and then to surface water.  In general, outdoor urban
uses are comprised of multiple, relatively small, temporally and
spatially variable applications, and urban scenarios relevant to this
use pattern have not been fully developed for models used by OPP. 
Runoff in urban areas may be impacted by pesticides in runoff (water or
sediment) or application to impermeable surfaces.  Aquatic exposure
modeling will be conducted for the outdoor use of cyphenothrin
(application to outdoor premises, patios by aerosol can/general surface
spray) based on conservative assumptions.  The potential for
cyphenothrin to reach surface water from the outdoor spray use may be
minimal based on the label language, but the potential exists and will
be evaluated.  

A second possible route of aquatic exposure results from wash-off from
spot-treatment of dogs or horses.  Label language states that treated
animals should be washed or rinsed if sensitivity is indicated after
treatment.  Therefore, the assessment will consider the potential of
wash-off from treated pets reaching surface waters, both from washing
treated pets and from pets immersing in streams, ponds or lakes. 
Possible evaluation of this type of exposure is laid out in detail in
the publically available Registration Review problem formulation for the
pyrethroid etofenprox (PC Code 128965;
http://www.epa.gov/oppsrrd1/registration_review/etofenprox/index.htm),
where Estimated Environmental Concentrations (EEC) are estimated using
conservative assumptions and the USEPA OPPT Down-the-Drain component of
the E-FAST model (see Appendix 2).  

For ponds and other water bodies, 100% of the cyphenothrin mass from a
conservative estimate of a number of treated animals could be considered
as potentially entering the waterbody.  The EPA standard pond (2,000,000
L) may be used determine exposure.  This might be a conservative
assumption considering that many spot treatments are designed to be
absorbed by the pet, thereby providing extended protection. 
Furthermore, the assessment could assume that 100% of the mass washed
from a pet will remain in the water column.  Given the low solubility of
cyphenothrin, this would also be a conservative assumption.

Given that cyphenothrin is a pyrethroid, it is possible that
cyphenothrin will sorb to benthic aquatic sediments or other solids
thereby reducing water column availability but increasing exposure to
benthic invertebrates.  In addition, there is the potential for
microbial degradation within treatment facilities (from the
Down-the-Drain assessment) that could further reduce cyphenothrin
concentrations prior to discharge.  Environmental fate data for
cyphenothrin are needed to better address these assumptions and
uncertainties.

For exposure to terrestrial organisms, spray drift from outdoor
applications may be intercepted by plant surfaces and forage items.  The
mass of cyphenothrin from a conservative drift assumption could be used
as an application rate in the EFED terrestrial exposure T-REX (v.1.4.1)
model.  Exposure to terrestrial animals through consumption of treated
feed items is estimated from the application rate using a nomogram
derived from the work of Hoerger and Kenaga (1972) and Fletcher et al.
(1994).  Potential for risk to plants may be estimated by using the
TerrPlant model (v.1.2.2).  Environmental fate data for cyphenothrin are
needed to better address assumptions and uncertainties related to
persistence and mobility in terrestrial environments..

C.  Measures of Effect

Ecological effects data are used as measures of direct and indirect
effects to biological receptors.  Data may be obtained from
registrant-submitted guideline studies or from literature studies
identified by ECOTOX.  The ECOTOX database will be searched in order to
provide more ecological effects data to better characterize potential
biological receptor reaction to cyphenothrin exposure.  ECOTOX is a
source for locating single chemical toxicity data and potential chemical
mixture toxicity data for aquatic life, terrestrial plants, and
wildlife.  ECOTOX was created and is maintained by the USEPA, Office of
Research and Development, and the National Health and Environmental
Effects Research Laboratory's Mid-Continent Ecology Division (USEPA
2007b).

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

  SEQ CHAPTER \h \r 1 The assessment of risk for direct effects to
non-target organisms makes the assumption that toxicity of cyphenothrin
to birds is similar of that to terrestrial-phase amphibians and
reptiles.  The same assumption is made for fish and aquatic-phase
amphibians. 

The acute measures of effect used for animals in this screening-level
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.  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.  For non-listed plants, only acute exposures
are assessed (i.e., EC25 for terrestrial plants and EC50 for aquatic
plants); for listed plants, either the NOAEC or EC05 is used.  

In the absence of data for either acute or chronic effects, cyphenothrin
toxicity will be presumed.  The absence of appropriate data will be
especially problematic for the endangered species effects determinations
and means of identifying mitigation that could potentially obviate such
determinations.

D.  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 cyphenothrin on porches, external home surfaces, and pets 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 cyphenothrin
risks, the risk quotient (RQ) method will be used to compare exposure
and measured toxicity values.  In this approach, 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
are used to indicate when cyphenothrin use, as directed on the label,
have the potential to cause adverse direct or indirect effects to
non-target organisms.  As noted previously, where data are lacking on
the toxicity of cyphenothrin, risk will be presumed.

The quantitative assessment of risk will primarily depend on the
deterministic point-estimate based approach described in the risk
assessment.  An effort will be made to further qualitatively describe
risk using probabilistic tools that the Agency has developed.  These
tools have been reviewed by FIFRA Scientific Advisory Panels and have
been deemed as appropriate means of refining assessments where
deterministic approaches have identified risks.

E.  Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered
Species Act (ESA), EPA will evaluate risks to Federally-listed
threatened and/or endangered (listed) species from registered uses of
cyphenothrin.  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 registrations of cyphenothrin
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 cyphenothrin application
occurs), plus all areas where offsite transport (i.e., wash-off, spray
drift, runoff of sediment-bound residues (erosion), etc.) may result in
potential exposure that exceeds the Agency’s LOCs.  Specific measures
of ecological effect that define the action area for listed species
include any direct and indirect effects and/or potential modification of
its critical habitat, including reduction in survival, growth, and
reproduction as well as the full suite of sublethal effects available in
the effects literature.  Therefore, the action area extends to a point
where environmental exposures are below any measured lethal or sublethal
effect threshold for any biological entity at the whole organism, organ,
tissue, and cellular level of organization.  In situations where it is
not possible to determine the threshold for an observed effect, the
action area is not spatially limited and is assumed to be the entire
United States.   

F.  Drinking Water Assessment

A drinking water assessment will not be conducted to support future
human health dietary risk assessments of cyphenothrin.  Based upon the
limited nature of the registered outdoor uses of cyphenothrin, and the
fact that there are no tolerances on food commodities, EFED does not
expect this compound to adversely impact groundwater or surface water
for human dietary exposure.  The Health Effects Division (HED) is not
going to conduct a dietary risk assessment for cyphenothrin.

G.  Preliminary Identification of Data Gaps 

1.  Fate

The environmental fate database for cyphenothrin is essentially
nonexistent.  To date, no environmental fate studies have been submitted
for this compound.  Based on 40 CFR Part 158, Subpart N (revised July 1,
2008) for labeling that includes residential outdoor uses, the following
studies are required but have not been submitted: hydrolysis, aerobic
soil metabolism and leaching and adsorption/desorption.  Because
cyphenothrin is a first generation pyrethroid, and those compounds may
be sensitive to photodegradation, additional data are required for
aqueous photolysis and are requested for soil photodegradation.
Additionally, anaerobic soil metabolism data are recommended to more
fully characterize the environmental fate of cyphenothrin.  Although
required under Part 158, EFED does not believe terrestrial field
dissipation studies would be useful for the risk assessment based on the
current use patterns of cyphenothrin.  The environmental fate data gaps
are listed in Table 3.

Table 3.  Available environmental data for cyphenothrin and remaining
data gaps.

158

Guideline

(OPPTS)	Description	MRID/

Accession	Classification	Data Gap?	Comments

161-1

(835.2120)	Hydrolysis	No data	--	Yes	Required under CFR 40 Part 158.

162-1

(835.4100)	Aerobic Soil Metabolism	No data	--	Yes

	

163-1

(835.1230

835.1240)	Leaching and Adsorption/ Desorption	No data	--	Yes

	164-1

(835.6100)	Terrestrial Field Dissipation	No data	--	No	Required under
CFR 40 Part 158, but not believed necessary for currently registered
uses

161-2

(835.2240)	Photodegradation in Water	No data	--	Yes	Required to
characterize exposure, including identification of potentially toxic
photoproducts.

161-3

(835.2410)	Photodegradation on Soil	No data	--	Yes*	Recommended to
characterize exposure.

162-2

(835.4100)	Anaerobic Soil Metabolism	No data	--	Yes*	Recommended to
characterize exposure. 

*No data have been submitted for these guidelines.  While not required
for outdoor residential uses, these data are recommended because they
would be expected to have a significant impact on the exposure
assessment, particularly with regard to aquatic exposure from treated
animals entering ponds.

2.  Effects

The cyphenothrin ecological effects data for aquatic and terrestrial
organisms are very limited.  These data gaps are highlighted below
(Tables 4-6).  Additionally, no data have been provided on the toxicity
of cyphenothrin degradates; as discussed previously, in the absence of
data to the contrary, any identified major degradates will be presumed
to be as toxic as the parent.  More thorough rationales regarding the
need for data is included in Appendix 3.  Effects, and potential risks,
are assumed by the Agency unless data indicate otherwise.

Because of the outdoor uses (use on structures that could be located
near water and use on pets), data are needed regarding the potential
toxicity of fish and aquatic invertebrates from chronic exposure to
cyphenothrin.  Since cyphenothrin may be expected to partition to
sediments in aquatic systems, toxicity to sediment-dwelling
invertebrates is being requested.  

Data should also be submitted for acute effects to estuarine and marine
animals.  These data are conditionally required for residential outdoor
pesticide uses.  Because cyphenothrin is very highly toxic to aquatic
animals on an acute exposure basis, and because some pyrethroids exhibit
greater toxicity in saltwater (Werner and Moran 2008), these data should
be submitted in order to conduct a thorough risk assessment.  

Data are necessary regarding the acute toxicity of cyphenothrin to
wildfowl, upland game species and to passerines due to the outdoor use. 
Additionally, data are needed regarding the reproductive effects of
chronic exposure of birds to cyphenothrin.  Data on the subacute dietary
toxicity of cyphenothrin to birds are available.

Data are needed for assessment of potential cyphenothrin toxicity to
terrestrial plants.  Although phytotoxicity data on insecticides was not
previously required for insecticides, CFR 40 Part 158, October 2007
requires at least a Tier I phytotoxicity study for all pesticides with
outdoor uses.  Given the reported incidents of phytotoxicity for the
similarly-structured pyrethroid permethrin, at least the vegetative
vigor terrestrial plant  data should be submitted for cyphenothrin.

There are no data available on the toxicity of cyphenothrin to honey
bees, although as an insecticide, adverse effects could be expected to
occur.  Although currently risk assessments are not conducted for
terrestrial invertebrates, the data would be used to examine relative
impacts to adult bees as well as brood and inform label precautions, if
effects are demonstrated.  There are data in the open literature
identified by ECOTOX that could provide information regarding the
toxicity of cyphenothrin to the aquatic-phase of insects.  These data
are generally from aggregate studies on pyrethroids in general and
conducted on target species.  Therefore, the submission of guideline
data for honey bees is recommended.

Additionally, CFR 40 Part 158 states that if ’an ingredient other than
the active ingredient is expected to enhance the toxicity of the active
ingredient’, toxicity data are required on the end-use product for
aquatic organisms.  Since cyphenothrin is formulated with a synergist,
aquatic toxicity data should be submitted for the formulated product.  

Table 4.  Available ecological effects data for terrestrial animals
exposed to technical cyphenothrin and remaining data gaps.

158

Guideline

(OPPTS)	Description	MRID/

Accession	Classification	Data Gap?	Comments

71-1

(850.2100)	Avian oral toxicity	--	NA	Yes	

Required under CFR 40 Part 158

71-2

(850.2200)	Avian dietary toxicity 	40983601	Acceptable	No

	71-4

(850.2300)	Avian reproduction	--	NA	Yes

	141-1

(850.3020)	Honeybee acute contact toxicity	--	NA	Yes

	

Table 5.  Available ecological effects data for aquatic animals exposed
to technical cyphenothrin and remaining data gaps. (NA=not applicable)

Guideline	Description	MRID/ Accession	Classification	Data Gap?	Comments

72-1

(850.1075)	Freshwater fish – 

Acute toxicity 	42436240	Acceptable	No1	

Required under CFR 40 Part 158

1However, data on the formulated product should be submitted

2An acute to chronic ratio may be used

3Cyphenothrin from spot-treatment wash-off is expected to partition to
sediment in aquatic systems where it is assumed to remain stable

42436239	Acceptable

72-3

(850.1075)	Saltwater fish – 

Acute toxicity 	No data	NA	Yes

	72-2

(850.1010)	Freshwater invertebrates –

Acute toxicity	43977313	Supplemental	No1

	41087502	Supplemental

72-3

(850.1025)

(850.1035)	Saltwater invertebrates –

Acute toxicity 	No data	NA	Yes

	72-4

(850.1300)	Freshwater  invertebrate –

 life cycle test	No data	NA	Yes

	72-4

(850.1350)	Saltwater invertebrates – 

life cycle test	No data*	NA	No2

	72-4

(850.1400)	Freshwater fish – 

early life stage test	No Data	NA	Yes

	72-4

(850.1400)	Saltwater fish – 

early life stage test	No data*	NA	No2

	850.1735	Whole sediment: acute freshwater invertebrates	No data*	NA
Yes3

	*Conditionally required for cyphenothrin

Table 6.  Available ecological effects data for plants exposed to
cyphenothrin and remaining data gaps.

Guideline	Description	MRID	Classification	Data Gap?	Comments

122-1

(850.4100)	Terrestrial Plant toxicity: Tier I seedling emergence	No data
NA	No	

While all these studies are required under CFR 40 Part 158, for the
current label use pattern only the vegetative vigor data are deemed
necessary for risk assessment

122-1

(850.4150)	Terrestrial Plant toxicity: Tier I vegetative vigor	No data
NA	Yes

	123-2

(850.4400, 4500, 4550)	Aquatic Plant Growth: algae	No data	NA	No

	123-2

(850.4400)	Aquatic Plant Growth: vascular plants	No data	NA	No

	

VIII.  References 

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

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

Spurlock F. and Marshall Lee.  2008.  Synthetic pyrethroid use patterns,
properties and environmental effects.  In: Synthetic Pyrethroids,
Occurrence and Behavior in Aquatic Environments.  J. Gan, F. Spurlock,
P. Hendley, D. Weston, editors ACS Symposium Series 991.  pp 3-25.

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.  
HYPERLINK "http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759" 
http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759  

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.  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.   HYPERLINK
"http://www.epa.gov/espp/consultation/ecorisk-overview.pdf" 
http://www.epa.gov/espp/consultation/ecorisk-overview.pdf  

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.   HYPERLINK
"http://www.epa.gov/oppefed1/ecorisk_ders/index.htm#framework" 
http://www.epa.gov/oppefed1/ecorisk_ders/index.htm#framework  

U. S. Environmental Protection Agency.  2007a.  Ecological Incident
Information System.    HYPERLINK
"http://www.epa.gov/espp/consultation/ecorisk-overview.pdf" 
http://www.epa.gov/espp/consultation/ecorisk-overview.pdf  

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

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

U.S. Geological Survey. 2008. National Water Quality Assessment (NAWQA)
program. Accessed 8 January 2008.   HYPERLINK
"http://water.usgs.gov/nawqa/"  http://water.usgs.gov/nawqa/ .

Werner, I. and K. Moran. 2008.  Effects of Pyrethroid Insecticides on
Aquatic Organisms.  In: Synthetic Pyrethroids, Occurrence and Behavior
in Aquatic Environments.  J. Gan, F. Spurlock, P. Hendley, D. Weston,
editors ACS Symposium Series 991.  pp 310-334.

Appendix 1  Accepted ECOTOX Papers

Cyphenothrin

Papers that Were Accepted for ECOTOX

Acceptable to EcoTox and OPP

Brempong-Yeboah, C. Y., Saito, T., and Miyata, T. (1983). Injection
Toxicity of Some Pyrethroids in the Armyworm.  J.Pestic.Sci. 8 : 95-98.

EcoReference No.: 112413

Chemical of Concern: HCCH,PYN,PTR,FNT,FPP,FNV,CYP,PMR,CHT;  Habitat:  T;
 Effect Codes:  MOR; Rejection Code:  LITE EVAL
CODED(CHT,PMR),TARGET(CYP,FNV,FPP,FNT).

Brempong-Yeboah, C. Y., Saito, T., and Miyata, T. (1985). Topical and
Injection Toxicities of Some Pyrethroids in the Housefly, Musca
domestica L.  Jpn.J.Sanit.Zool. 36: 31-38.

EcoReference No.: 112648

Chemical of Concern: FNT,FNV,CYP,PMR,CHT,SMT,HCCH;  Habitat:  T;  Effect
Codes:  MOR,PHY; Rejection Code:  LITE EVAL
CODED(CHT),TARGET(FNT,FNV,CYP,PMR,SMT).

Erkmen, B., Caliskan, M., and Yerli, S. V. (2000). Histopathological
Effects of Cyphenothrin on the Gills of Lebistes reticulatus. 
Vet.Hum.Toxicol. 42: 5-7.

EcoReference No.: 110977

Chemical of Concern: CHT;  Habitat:  A;  Effect Codes:  MOR,CEL;
Rejection Code:  LITE EVAL CODED(CHT).

Halliday, W. R., Morgan, N. O., and Kirkpatrick, R. L. (1987).
Evaluation of Insecticides for Control of Stored-Product Pests in
Transport Vehicles.  J.Entomol.Sci. 22: 224-236.

EcoReference No.: 70501

Chemical of Concern:
SMT,TMT,MOM,BDC,BFT,ACP,CHT,FPP,CYP,PMR,FNV,DDT,CBL,RSM,PPB;  Habitat: 
T;  Effect Codes:  MOR; Rejection Code:  LITE EVAL CODED(CHT),OK(PMR),NO
MIXTURE(PPB,CBL),NO
ENDPOINT(TMT),TARGET(SMT,FNV,CYP,FVL,CYF,FPP,BFT,RSM,ACP,MOM).

Itoh, T., Shinjo, G., and Kurihara, T. (1986). Studies on Wide Mesh
Netting Impregnated with Insecticides Against Culex Mosquitoes. 
J.Am.Mosq.Control Assoc. 2: 503-506.

EcoReference No.: 91567

Chemical of Concern: FPP,FNT,SMT,FNV,PMR,PLL,CHT;  Habitat:  T;  Effect
Codes:  MOR; Rejection Code:  LIGHT EVAL
CODED(CHT),TARGET(FPP,FNT,SMT,FNV,PMR,PLL).

Mikhail, M. W., Al-Bursheed, K. M., and Allam, K. A. M. (2007).
Susceptibility of Culex pipiens Complex to Some Insecticides in Qatar. 
J.Egypt.Soc.Parasitol. 37: 893-902.

EcoReference No.: 110956

Chemical of Concern: EFX,CPY,CHT,PTP,CYF;  Habitat:  A;  Effect Codes: 
MOR; Rejection Code:  LITE EVAL CODED(CPY,CHT),OK(EFX,PTP,CYF).

Rani, P. U. and Osmani, Z. (1984). Studies on the Toxic, Repellent and
Attractant Properties of Certain Insecticides Towards the Housefly,
Musca domestica nebulo (L.).  Int.Pest Control 26: 72-74.

EcoReference No.: 112684

Chemical of Concern: CHT,DM,FNV;  Habitat:  T;  Effect Codes:  BEH,MOR;
Rejection Code:  LITE EVAL CODED(CHT),TARGET(DM).

Rani, P. U. and Osmani, Z. (1982). Toxicity and Repellency of Certain
Synthetic Pyrethroids Against Musca domestica (L), and Dysdercus
cingulatus (F).  Pesticides 16: 7-9.

EcoReference No.: 112687

Chemical of Concern: CHT,FNV,ATN;  Habitat:  T;  Effect Codes:  MOR,BEH;
Rejection Code:  LITE EVAL CODED(CHT),TARGET(FNV,ATN).

Segawa, T., Nomura, Y., Nishio, H., and Nakata, Y. (1983).
Pharmacological Activities of (RS)-alpha-Cyano-3-phenoxybenzyl
(1R)-cis,trans-chrysanthemate (S-2703 forte).  Oyo Yakuri 26: 613-625.

EcoReference No.: 112649

Chemical of Concern: CHT;  Habitat:  T;  Effect Codes:  BEH,PHY;
Rejection Code:  LITE EVAL CODED(CHT).

Shim, J. C., Lee, D. K., and Lee, K. W. (1997). Insecticide
Susceptibility of German Cockroaches (Blattaria:  Blattellidae) in
Seoul.  Korean J.Entomol. 27: 73-77.

EcoReference No.: 112850

Chemical of Concern:
BFT,DCTP,CPY,DM,DZ,PFF,ATN,CYP,PMR,EFX,FNTH,LCYT,FNT,TMT,CHT,PTR; 
Habitat:  T;  Effect Codes:  MOR; Rejection Code:  LITE EVAL
CODED(CHT),TARGET(EFX,PMR,TMT,CYP,ATN,PFF,DZ,DM,CPY,DCTP,BFT).

Tsuji, R., Isobe, N., and Kawasaki, H. (1996). Effect of Pyrethroids on
Pentobarbital-Induced Sleeping Time in Relation to the Chemical
Structure.  Toxicology 106: 131-137.

EcoReference No.: 70397

Chemical of Concern: PLL,ATN,FPP,SMT,FNV,CHT,PMR,CYP,RSM;  Habitat:  T; 
Effect Codes:  BEH; Rejection Code:  LITE EVAL
CODED(CHT,ATN,FPP,PLL,CYP,RSM,FNV,SMT,PMR,CHT),NO COC(TMT).

Weerasinghe, I. S., Kasai, S., and Shono, T.  (2001). Correlation of
Pyrethroid Structure and Resistance Level in Culex quinquefasciatus Say
from Saudi Arabia.  J.Pestic.Sci. 26: 158-161.

EcoReference No.: 66182

Chemical of Concern: TMT,RSM,SMT,PMR,FNV,CHT,CYP,CYF,ATN,EFX,BFT,DM; 
Habitat:  A;  Effect Codes:  MOR; Rejection Code:  LITE EVAL
CODED(CHT,CYF,BFT,DM),OK(TMT,RSM,SMT,PMR,FNV,CYP,EFX),TARGET(ATN).

Yameogo, L., Tapsoba, J. M., and Calamari, D. (1991). Laboratory
Toxicity of Potential Blackfly Larvicides on Some African Fish Species
in the Onchocerciasis Control Programme Area.  Ecotoxicol.Environ.Saf.
21: 248-256.

EcoReference No.: 3042

Chemical of Concern: PMR,CHT;  Habitat:  A;  Effect Codes:  MOR;
Rejection Code:  LITE EVAL CODED(PMR,CHT).

Acceptable to EcoTox but not OPP

Abe, Y., Senbo, S., Takada, Y., Kawada, H., and Ito, T. (1994). The
Effectiveness of Prallethrin Against Public Health Pests.  Brighton Crop
Prot.Conf.-Pests Dis. 3: 1023-1030.

EcoReference No.: 111802

Chemical of Concern: DM,CYP,LCYT,EFV,PMR,TMT,PLL,SMT,CHT,PPX,DDVP,PYN; 
Habitat:  T;  Effect Codes:  MOR; Rejection Code:  LITE EVAL
CODED(PLL),OK(SMT,TMT,PMR,DDVP,CYP,EFV),NO MIXTURE(CHT,PPX),NO
DURATION(DM).

Brempong-Yeboah, C. Y., Saito, T., and Miyata, T. (1984). The Selective
Toxicity of Some Synthetic Pyrethroids in the Armyworm, Pseudaletia
separata (Walker)  III.  Cuticle Permeabilities of Some Pyrethroids. 
Appl.Entomol.Zool. 19: 87-94.

EcoReference No.: 112566

Chemical of Concern: PMR,FNV,CHT;  Habitat:  T;  Effect Codes:  MOR,PHY;
Rejection Code:  NO ENDPOINT(PMR,CHT),TARGET(FNV).

Brempong-Yeboah, C. Y., Saito, T., and Miyata, T. (1984). Topical and
Injection Toxicities of Some Pyrethroids in the Tobacco Cutworm,
Spodoptera litura Fabricius.  J.Pestic.Sci.(Nippon Noyaku Gakkaishi) 9:
481-487.

EcoReference No.: 112900

Chemical of Concern: FPP,FNV,CYP,PMR,CHT,SMT,HCCH,FNT;  Habitat:  T; 
Effect Codes:  MOR,PHY; Rejection Code:  NO
CONTROL(CHT,SMT,PMR,CYP,FNV,FPP).

Brempong-Yeboah, C. Y., Saito, T., and Miyata, T. (1984). Topical and
Injection Toxicities of Some Pyrethroids to the German Cockroach,
Blattella germanica (Dictyoptera:  Blattellidae).  Appl.Entomol.Zool.
19: 348-355.

EcoReference No.: 112414

Chemical of Concern: HCCH,PYN,PTR,FNT,FPP,FNV,CYP,PMR,CHT;  Habitat:  T;
 Effect Codes:  MOR; Rejection Code:  NO
CONTROL(CHT,PMR),TARGET(CYP,FNV,FPP,FNT).

Brempong-Yeboah, C. Y., Saito, T., Miyata, T., and Tsubaki, Y. (1982).
Topical Toxicity of Some Pyrethroids.  J.Pestic.Sci. 7 : 47-51.

EcoReference No.: 72072

Chemical of Concern: CPY,PYN,HCCH,PMR,SMT,CHT,FPP,FNV,FNT;  Habitat:  T;
 Effect Codes:  MOR,PHY,BEH; Rejection Code:  NO
CONTROL(CPY,PYN,HCCH,PMR,SMT,CHT,FPP,FNV,FNT).

Clements, A. N. and May, T. E. (1977). The Actions of Pyrethroids Upon
the Peripheral Nervous System and Associated Organs in the Locust. 
Pestic.Sci. 8: 661-680.

EcoReference No.: 112851

Chemical of Concern: FNV,ATN,TMT,CHT,PYN;  Habitat:  T;  Effect Codes: 
MOR; Rejection Code:  NO CONTROL(FNV,ATN,TMT,CHT).

De Sousa, B., Schmid, W., Hefti, H., and Bellus, D. (1982). The
Biological Evaluation of Pyrethroids as Potential Mothproofing Agents. 
I.  Esters of 2-Substituted 3,3-Dimethylcyclopropane-1-Carboxylic Acids.
 J.Soc.Dyers Colour. 98: 79-84.

EcoReference No.: 112439

Chemical of Concern: CHT,DM,CYP,PMR,SMT;  Habitat:  T;  Effect Codes: 
MOR; Rejection Code:  NO CONTROL,NO ENDPOINT(CHT,DM,CYP,PMR,SMT).

Elliott, M., Farnham, A. W., Janes, N. F., and Khambay, B. P. S. (1982).
Insecticidal Activity of the Pyrethrins and Related Compounds.  Part
XII.  Alpha-Substituted-3-Phenoxybenzyl Esters.  Pestic.Sci. 13:
407-414.

EcoReference No.: 112686

Chemical of Concern: CHT;  Habitat:  T;  Effect Codes:  MOR; Rejection
Code:  NO ENDPOINT(CHT).

Elliott, M., Janes, N. F., Khambay, B. P. S., and Pulman, D. A. (1983).
Insecticidal Activity of the Pyrethrins and Related Compounds.  Part
XIII:  Comparison of the Effects of alpha-Substituents in Different
Esters.  Pestic.Sci. 14: 182-190 .

EcoReference No.: 112685

Chemical of Concern: CHT;  Habitat:  T;  Effect Codes:  MOR; Rejection
Code:  NO ENDPOINT(CHT).

Fuchs, M. E. A. (1988). Flushing Effects of Pyrethrum and Pyrethroid
Insecticides Against the German Cockroach (Blattella germanica L.). 
Pyrethrum Post 17: 3-7.

EcoReference No.: 112852

Chemical of Concern: CHT;  Habitat:  T;  Effect Codes:  BEH; Rejection
Code:  NO CONTROL,NO ENDPOINT(PPB,CYF,CYP,DM,CHT,TMT,PMR,RSM,SMT,TMT).

Hama, H. (1987). Development of Pyrethroid Resistance in the Diamondback
Moth, Plutella xylostella LINNE (Lepidoptera:  Yponomeutidae). 
Appl.Entomol.Zool. 22: 166-175.

EcoReference No.: 112647

Chemical of Concern:
FNV,PMR,RSM,CYP,CHT,SMT,FPP,TMT,FVL,MLN,PFF,MOM,CBL,PPB,DDT,PYN; 
Habitat:  T;  Effect Codes:  MOR; Rejection Code:  NO MIXTURE(PPB),NO
CONTROL(CHT,FNV,PMR,CYP,SMT,FPP,TMT,FVL,MLN,PFF,MOM,CBL),TARGET(EFV).

Joy, R. M., Lister, T., Ray, D. E., and Seville, M. P. (1990).
Characteristics of the Prolonged Inhibition Produced by a Range of
Pyrethroids in the Rat Hippocampus.  Toxicol.Appl.Pharmacol. 103:
528-538.

EcoReference No.: 92944

Chemical of Concern: DM,FNV,CHT;  Habitat:  T;  Effect Codes:  BEH,BCM;
Rejection Code:  NO ENDPOINT(FNV,DM,CHT).

Kaneko, H., Matsuo, M., and Miyamoto, J. (1984). Comparative Metabolism
of Stereoisomers of Cyphenothrin and Phenothrin Isomers in Rats. 
J.Pestic.Sci. 9: 237-247.

EcoReference No.: 91927

Chemical of Concern: SMT,CHT;  Habitat:  T;  Effect Codes:  ACC;
Rejection Code:  NO ENDPOINT,NO CONTROL(SMT,CHT).

Lee, C. Y., Yap, H. H., and Chong, N. L. (1996). Insecticide Toxicity on
the Adult German Cockroach, Blattella germanica (L.) (Dictyoptera:
Blattellidae).  Malays.J.Sci. 17A: 1-9.

EcoReference No.: 68667

Chemical of Concern: BCY,BDC,BFT,CPY,CYP,CHT,DM,EFX,FNT,LCYT,PMR,PPX; 
Habitat:  T;  Effect Codes:  MOR; Rejection Code:  NO
CONTROL(BCY,BDC,BFT,CPY,CYP,CHT,DM,EFX,FNT,LCYT,PMR,PPX).

Lindsay, S. W., Hossain, M. I., Bennett, S., and Curtis, C. F. (1991).
Preliminary Studies on the Insecticidal Activity and Wash-Fastness of
Twelve Pyrethroid Treatments Impregnated into Bednetting Assayed Against
Mosquitoes.  Pestic.Sci. 32: 397-411 .

EcoReference No.: 112688

Chemical of Concern: LCYT,CHT,PMR,CYF,CYP,SMT,FPP,FNV,DM;  Habitat:  T; 
Effect Codes:  MOR; Rejection Code:  NO
ENDPOINT(CHT,PMR,CYF,CYP,SMT,FPP,FNV,DM).

Lucas, J. R., Ayzeren, C., Bowron, M., and Invest, J. F. (1996). Water
Based Space Spray Technology the Fast Way to Control Flying Insects. 
Int.Pest Control 38: 111-113 .

EcoReference No.: 112857

Chemical of Concern: CHT,DM,TMT,LCYT,PPB;  Habitat:  T;  Effect Codes: 
MOR,POP; Rejection Code:  MIXTURE(TMT,PPB,CHT),NO ENDPOINT(DM).

Matsunaga, T., Yoshida, K., Shinjo, G., Tsuda, S., Okuno, Y., and
Yoshioka, H. (1983). New Pyrethroid Insecticides for Indoor
Applications.  In: J.Miyamoto and P.C.Kearney (Eds.), Proc.5th
Int.Congr., Pestic.Chem.: Hum.Welfare Environ., Vol.2 Natural Products,
Pergamon Press, New York 231-238.

EcoReference No.: 112287

Chemical of Concern: ATN,PPX,DDVP,FNT,PMR,DTATN,PYN;  Habitat:  T; 
Effect Codes:  MOR; Rejection Code:  NO
CONTROL(DTATN,PMR,FNT,DDVP,PPX,ATN).

Moustafa, M. and Metwally, M. M. (1992). New Rosin-Modified Varnish
Compositions of Effective Pest Control.  Pigm.Resin Technol. 21: 12-15.

EcoReference No.: 112453

Chemical of Concern: SMT,CHT,TMT;  Habitat:  T;  Effect Codes:  MOR;
Rejection Code:  NO MIXTURE(SMT,CHT,TMT).

Mulla, M. S., Darwazeh, H. A., and Ede, L. (1982). Evaluation of New
Pyrethroids Against Immature Mosquitoes and Their Effects on Nontarget
Organisms.  Mosq.News 42: 583-590.

EcoReference No.: 10971

Chemical of Concern: FPP,CYP,PYT,CHT;  Habitat:  A;  Effect Codes: 
MOR,POP; Rejection Code:  LITE EVAL CODED(CYP),OK(FPP,PYT),NO
CONTROL(CHT).

Nishimura, K., Kobayashi, T., and Fujita, T.  (1986). Symptomatic and
Neurophysiological Activities of New Synthetic Non-Ester Pyrethroids,
Ethofenprox, MTI-800, and Related Compounds.  Pestic.Biochem.Physiol.
25: 387-395.

EcoReference No.: 110147

Chemical of Concern: FNV,ATN,CHT;  Habitat:  AT;  Effect Codes:  PHY;
Rejection Code:  NO ENDPOINT,NO CONTROL(ATN,CHT,FNV).

Roberts, R. H., Stark, P. M., and Meisch, M. V. (1984). Aerosol
Evaluation of Selected Adulticides Against Colonized and Field Strains
of Mosquitoes.  Mosq.News 44: 528-533.

EcoReference No.: 112415

Chemical of Concern: HCCH,DDT,MLN,CHT;  Habitat:  T;  Effect Codes: 
MOR; Rejection Code:  NO CONTROL(MLN,CHT).

Stejskal, V., Aulicky, R., and Pekar, S. (2008). Brief Exposure of
Blattella germanica (Blattodea) to Insecticides Formulated in Various
Microcapsule Sizes and Applied on Porous and Non-porous Surfaces.  Pest
Manag.Sci. 65: 93-98.

EcoReference No.: 112517

Chemical of Concern: FNT,DZ,CPY,CHT;  Habitat:  T;  Effect Codes:  MOR;
Rejection Code:  NO CONTROL,NO ENDPOINT(CHT,CPY).

Tonkopii, V. (2006). Bioidentification of Xenobiotics in Water as a Part
of Pollution Control.  In: Proc.11th World Lakes Conf., Oct.31-Nov.4,
Nairobi, Kenya 2: 371-373.

EcoReference No.: 93004

Chemical of Concern:
CHT,RSM,ATN,DM,FNV,PCB,EN,DLD,AND,MLO,CBL,Cu,Co,Cd,Cr,As,Al,DDVP,DDT,HCC
H,HgCl2,PbN,CYP,PMR,SMT;  Habitat:  A;  Effect Codes:  MOR; Rejection
Code:  NO
CONTROL(CHT,RSM,ATN,DM,FNV,PCB,EN,DLD,AND,MLO,CBL,Cu,Co,Cd,Cr,As,Al,DDVP
,DDT,HCCH,HgCl2,PbN,CYP,PMR,SMT),NO
EFFECT(RSM,ATN,FNV,MLO,CBL,Cu,Cr,As).

Wright, C. D. P., Forshaw, P. J., and Ray, D. E. (1988). Classification
of the Actions of Ten Pyrethroid Insecticides in the Rat Using the
Trigeminal Reflex and Skeletal Muscle as Test Systems. 
Pestic.Biochem.Physiol. 30: 79-86.

EcoReference No.: 81428

Chemical of Concern: PYT,CYF,DM,EFV,CHT,CYH,FPP,RSM,FSF;  Habitat:  T; 
Effect Codes:  BEH,PHY; Rejection Code:  NO
CONTROL(PYT,CYF,DM,EFV,CHT,CYH,FPP,RSM,FSF).

Yap, H. H., Lee, Y. W., Zairi, J., Jahangir, K., and Adanan, C. R.
(2001). Indoor Thermal Fogging Application of Pesguard FG 161, a Mixture
of d-Tetramethrin and Cyphenothrin, Using Portable Sprayer Against
Vector Mosquitoes in the Tropical Environment.  J.Am.Mosq.Control Assoc.
17: 28-32.

EcoReference No.: 80753

Chemical of Concern: ATN,PPB,SMT,TMT,CHT;  Habitat:  A;  Effect Codes: 
MOR,PHY; Rejection Code:  NO CONTROL(ATN,PPB,SMT,TMT,CHT).



Appendix 2  Down-the-Drain Scenario for Pet Spot Treatments from the
Etofenprox Registration Review Problem Formulation

Document available at
(http://www.epa.gov/oppsrrd1/registration_review/etofenprox/index.htm)

Preliminary Assessment: Based on Spot Treatment for Pets

There is potential for discharge of etofenprox into surface water as a
result of washing pets (cats only) that have been treated with
etofenprox as a preventative spot treatment.  EECs are estimated using
multiple conservative assumptions and the USEPA OPPT Down-the-Drain
component of the E-FAST model.  

It assumes that there is no degradation of etofenprox as a result of
water flows through treatment works and that 100% of the applied
etofenprox is washed off the cat and is dissolved in the waste water.  

Given a spot treatment containing 55% etofenprox, a specific gravity of
1.062, and a treatment volume of 2 ml, the amount of etofenprox in one
treatment is about 1.17 g.  Based on the Down-the-Drain component of the
E-FAST model, the 50th percentile per capita daily indoor water usage is
388 L per person, or 1552 L per day for a family of four.  The
concentration of etofenprox in the waste stream given the above
conditions would be 753 ppb ((g/L).  However, this estimated
concentration would be diluted by the wastewater flows from other
households that do not have pets and/or are not using the etofenprox
formulated treatment and/or are not washing their pets on a given day. 
The American Water Works Association estimates that total per capita
wastewater production for municipalities is about 689 L/person/day.  A
recalculation of the estimated etofenprox calculation using this water
usage estimate yields an EEC of 424 ppb.  

In a typical 50,000 person municipality, the number of cats that must be
washed on a given day to equal the endangered species LOC for freshwater
invertebrates (0.57 µg/L X 0.05 = 0.0285 µg/L) and fish (2.7 µg/L X
0.05 = 0.135 µg/L) would be:

Aquatic Invertebrates:

	Number of cats = [(0.0285 g/L)(50,000 people)(689 L/person)]/1.2E+06
µg/dog)

		Number of cats = 0.84 

Fish	

	Number of cats = [(0.135 g/L)(50,000 people)(689 L/person)]/1.2E+06
µg/dog)

 		Number of cats = 3.98

This analysis indicates that in a municipality of 50,000 people, there
would be sufficient etofenprox in the untreated municipal wastewater
discharge from treatment facilities to exceed the listed species acute
risk LOC for invertebrates if one cat was washed.  For listed fish, four
cats would need to be washed for concentrations of etofenprox in the
untreated wastewater to exceed the listed species acute risk LOC. 

As stated above, this approach incorporates several conservative
assumptions.  The assessment method assumes that 100% of the etofenprox
applied to cats is removed during pet washing.  This is a conservative
assumption considering that many spot treatments are designed to be
absorbed by the pet thereby providing extended protection.  Furthermore,
this assessment assumes that 100% of the etofenprox washed from a pet
remains in the water column.  Given that etofenprox is similar to
pyrethroids, it is possible that etofenprox will sorb to sediments or
other solids thereby reducing availability.  In addition, there is the
potential for microbial degradation within treatment facilities that
would further reduce etofenprox concentrations.  Environmental fate data
for etofenprox is needed to better address these assumptions and
uncertainties.

Appendix 3.  Data Call-in Justification.

Guideline Number:  850.1300 & 1400

Study Title:   Aquatic Invertebrate Life Cycle (freshwater) and Fish
Early-Life-stage (freshwater)

Rationale for Requiring the Data

Chronic invertebrate life cycle and fish early life-stage data are
required under 40 CFR Part 158 (2008) data requirements for pesticides
with residential outdoor uses.  These data are necessary to determine if
chronic exposure to cyphenothrin may adversely affect the survival,
growth or reproduction of aquatic wildlife.

Practical Utility of the Data

How will the data be used?

These data are necessary to characterize the potential risks from
cyphenothrin to aquatic invertebrates, freshwater fish and aquatic-phase
amphibians (for which the fish serve as surrogates).  The available
acute toxicity data indicate that cyphenothrin is very highly toxic to
aquatic invertebrates and freshwater fish.  Chronic exposure data will
be used in the screening-level risk assessment to estimate the scope of
sublethal effects and potential chronic risks to freshwater aquatic
wildlife associated with the outdoor uses of cyphenothrin.   In the
absence of these data the Agency will presume effects to aquatic
wildlife from chronic exposure to cyphenothrin.

How could the data change the Agency’s decision or 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 cyphenothrin “may
affect” listed aquatic species directly (and listed species from other
taxa indirectly), and use of cyphenothrin and its formulated products
may need to be restricted in areas where listed species could be
exposed.  The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for cyphenothrin use
that are unnecessarily severe.

Guideline Number:  850.1735

Study Title:   Whole Sediment: Acute Freshwater Invertebrates

Rationale for Requiring the Data

Acute toxicity to sediment-dwelling invertebrates data are conditionally
required under 40 CFR Part 158 (2008) data requirements for pesticides
with residential outdoor uses.  Since cyphenothrin is expected to
partition to sediments and may bioaccumulate in the aquatic food chain,
these data are necessary to determine if cyphenothrin may adversely
affect the survival, growth or reproduction of aquatic invertebrates
and, indirectly, higher trophic-level organisms.

Practical Utility of the Data

How will the data be used?

These data are necessary to characterize the potential risks from
cyphenothrin to aquatic invertebrates, freshwater fish and aquatic-phase
amphibians (for which the fish serve as surrogates) and other higher
trophic-level species.  The available acute toxicity data indicate that
cyphenothrin is very highly toxic to aquatic invertebrates and
freshwater fish.   In the absence of these data the Agency will presume
effects to sediment-dwelling invertebrates.

How could the data change the Agency’s decision or 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 cyphenothrin “may
affect” listed aquatic species directly (and listed species from other
taxa indirectly), and use of cyphenothrin and its formulated products
may need to be restricted in areas where listed species could be
exposed.  The lack of these data will limit the flexibility the Agency
and registrants have in coming into compliance with the Endangered
Species Act and could result in use restrictions for cyphenothrin use
that are unnecessarily severe.

Guideline Number:  850.2100 

Study Title:  Avian Acute Oral Toxicity 

Rationale for Requiring the Data

Acceptable avian acute oral toxicity data have not been submitted for
exposure of birds to cyphenothrin; these data are required under the 40
CFR Part 158 (2008) for pesticides with outdoor uses.  The new Part 158
data requirements specify that avian acute oral toxicity data be
submitted for either mallard duck or bobwhite quail and a passerine
species.  These data are necessary to determine the inherent toxicity of
cyphenothrin to avian species independent of dietary exposure.

Practical Utility of the Data

How will the data be used?

Avian acute oral toxicity data will be used in the screening-level
assessment to determine whether there are differences in avian
species’ sensitivity to cyphenothrin.  If oral acute toxicity data are
not submitted, risk will be assumed for all avian species.

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 cyphenothrin “may
affect” listed birds directly (and listed species from other taxa
indirectly), and use of cyphenothrin and its formulated products may
need to be restricted in areas where listed species could be exposed. 
The lack of these data will limit the flexibility the Agency and
registrants have in coming into compliance with the Endangered Species
Act and could result in use restrictions for cyphenothrin use that are
unnecessarily severe.

Guideline Number:  850.2300 

Study Title:  Avian Reproduction

Rationale for Requiring the Data

Avian reproduction toxicity data have not been submitted for chronic
exposure of birds to cyphenothrin; these data are required under the 40
CFR Part 158 (2008) for pesticides with outdoor uses.  The Part 158 data
requirements specify that avian reproduction toxicity data be submitted
for both mallard duck and bobwhite quail.  These data are necessary to
determine the reproductive toxicity of cyphenothrin to avian species
from chronic exposure.

Practical Utility of the Data

How will the data be used?

Avian reproduction toxicity data for mallard ducks and bobwhite quail
will be used in the screening-level assessment to determine whether
there are effects on birds from chronic exposure to cyphenothrin.  If
reproductive toxicity data are not submitted, risk will be assumed for
all avian species.

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 cyphenothrin “may
affect” listed birds directly (and listed species from other taxa
indirectly), and use of cyphenothrin and its formulated products may
need to be restricted in areas where listed species could be exposed. 
The lack of these data will limit the flexibility the Agency and
registrants have in coming into compliance with the Endangered Species
Act and could result in use restrictions for cyphenothrin use that are
unnecessarily severe.

Guideline Number:  850.3020

Study Title:  Honeybee Acute Contact Toxicity

Rationale for Requiring the Data

Honeybee acute contact toxicity data have not been submitted for
cyphenothrin; these data are required under the 40 CFR Part 158 (2008)
for pesticides with outdoor uses.  These data are necessary to determine
the toxicity of cyphenothrin to honeybees.

Practical Utility of the Data

How will the data be used?

Acute contact toxicity data for honeybees will be used in the
screening-level assessment to determine whether there are potential
adverse effects to honeybees from the use of cyphenothrin.

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

Without these data, risk to honeybees and other beneficial insects will
be presumed.  If endangered species risk assessments are performed
without these data, the Agency would have to assume that cyphenothrin
“may affect” listed birds, and use of cyphenothrin and its
formulated products may need to be restricted in areas where listed
species could be exposed.  The lack of these data will limit the
flexibility the Agency and registrants have in coming into compliance
with the Endangered Species Act and could result in use restrictions for
cyphenothrin that are unnecessarily severe.

Guideline Number:  850.4150 

Study Title: Terrestrial Plant Toxicity-Vegetative Vigor 

Rationale for Requiring the Data

Data regarding the toxicity of cyphenothrin to terrestrial plants have
not been submitted to the Agency.  These data are required under the 40
CFR Part 158 (2008) data requirements for pesticides with outdoor uses. 
These data are necessary to determine whether the outdoor use of
cyphenothrin could adversely affect terrestrial plants.

Practical Utility of the Data

How will the data be used?

These data will be used to determine the potential for cyphenothrin to
affect non-target plant species in the terrestrial environment.  In the
absence of data specific for these plants, risk to terrestrial plants
will be assumed.  Because plants are primary producers, providing the
foundation of food sources for all animal species and habitat for most,
the lack of these data may require the Agency to presume indirect
affects to all species.

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

If endangered species risk assessments are performed without these data,
the Agency would have to presume direct risk to non-target plants and
indirect risk to all animal species from use of cyphenothrin. 
Therefore, use of cyphenothrin and its formulated products may need to
be restricted in areas where listed species could be exposed.  The lack
of these data will limit the flexibility the Agency and registrants have
in coming into compliance with the Endangered Species Act and could
result in use restrictions for cyphenothrin that are unnecessarily
severe.

Guideline Number:  835.2120

Study Title:   Hydrolysis

Rationale for Requiring the Data

Acceptable data on the hydrolysis of cyphenothrin are required under 40
CFR Part 158, Subpart N (revised July 1, 2008) for labeling that
includes residential outdoor uses.  The Agency has a limited
understanding of the environmental fate of cyphenothrin.  Neither
hydrolysis data nor a waiver request have been submitted to the Agency.

Practical Utility of the Data

How will the data be used?

Currently there are no hydrolysis studies that provide information on
the fate of cyphenothrin in water.  The submitted data will be used to
help characterize and quantify the environmental fate of cyphenothrin
and any potential degradates in aquatic environments.  For quantitative
exposure estimation, these data will be used in modeling estimated
environmental concentrations (EECs) of cyphenothrin for the aquatic
exposure assessment.  

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

In the absence of the requested data, cyphenothrin will be assumed to be
stable to hydrolysis.  This assumption will constitute an uncertainty in
the risk assessment.  Additionally, the identity of any potential
degradates that could be of toxic concern would remain an unknown.

Guideline Number:  835.2240

Study Title:   Photodegradation in Water

Rationale for Requiring the Data

Acceptable data on the photodegradation of cyphenothrin in water are
required under 40 CFR Part 158, Subpart N (revised July 1, 2008) for
labeling that includes aquatic uses.  Although a direct aquatic use is
not being assessed, there is a potential for direct aquatic exposure due
to the entry of treated animals into ponds.  The Agency has a limited
understanding of the environmental fate of cyphenothrin.  Because
cyphenothrin is known to be photolabile, it is required that the
photoproducts be identified to fully characterize the environmental fate
of this compound.  

Practical Utility of the Data

How will the data be used?

Currently there are no photodegradation in water studies that provide
information on the fate of cyphenothrin.  The submitted data will be
used to help characterize and quantify the environmental fate of
cyphenothrin and any potential degradates in aquatic environments.  For
quantitative exposure estimation, these data will be used in modeling
estimated environmental concentrations (EECs) of cyphenothrin for the
aquatic exposure assessment.  

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

In the absence of the requested data, cyphenothrin will be assumed to be
stable to photodegradation.  This assumption will constitute an
uncertainty in the risk assessment.  Additionally, the identity of any
potential degradates that could be of toxic concern would remain an
unknown.

Guideline Number:  835.4100

Study Title: Aerobic Soil Metabolism

Rationale for Requiring the Data

Acceptable data on the aerobic soil metabolism of cyphenothrin are
required under 40 CFR Part 158, Subpart N (revised July 1, 2008) for
labeling that includes residential outdoor uses.  The Agency has a
limited understanding of the environmental fate of cyphenothrin. 
Aerobic soil metabolism data have not been submitted to the Agency.  

Practical Utility of the Data

How will the data be used?  

Currently there are no aerobic soil metabolism studies that provide
information on the fate of cyphenothrin in soil.  The submitted data
will be used to help characterize and quantify the environmental fate of
cyphenothrin and any potential degradates in the environment.  For
quantitative exposure estimation, these data will be used in modeling
estimated environmental concentrations (EECs) of cyphenothrin for the
aquatic exposure assessment.  

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

In the absence of the requested data, cyphenothrin will be assumed to be
stable to microbial metabolism in soil.  This assumption will constitute
an uncertainty in the risk assessment. Additionally, the identity of any
potential degradates that could be of toxic concern would remain an
unknown. 

Guideline Number:  835.1230 and 835.1240

Study Title:  Leaching and adsorption/desorption

Rationale for Requiring the Data

Acceptable data on the leaching and adsorption/desorption of
cyphenothrin are required under 40 CFR Part 158, Subpart N (revised July
1, 2008) for labeling that includes residential outdoor uses.  The
Agency has a limited understanding of the environmental fate of
cyphenothrin.  Adsorption/desorption data have not been submitted to the
Agency.  

Practical Utility of the Data

How will the data be used?  

Currently there are no leaching and adsorption/desorption studies that
provide information on the potential leaching behavior of cyphenothrin
in soil.  The submitted data will be used to help characterize and the
environmental fate of cyphenothrin in the environment.  For quantitative
exposure estimation, these data will be used in modeling estimated
environmental concentrations (EECs) of cyphenothrin for the aquatic
exposure assessment. Adsorption/ desorption data using the batch
equilibrium method are preferred.  If the compound is found to rapidly
degrade to a major compound in soil, then soil column leaching methods
(aged and unaged) may be more appropriate.  If the compound rapidly
degrades in soil to a major degradate(s), then adsorption/desorption
data on the major degradate(s) should also be submitted.

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

In the absence of the requested data, the potential leaching behavior of
cyphenothrin will be an unknown, and will constitute an uncertainty in
the risk assessment.

Page   PAGE  1  of   NUMPAGES  41 

Uptake/ Adsorption

Aquatic Plants

Plant Population

Reduced population growth

Individual Vertebrates and Invertebrates Reduced survival or
reproduction

Individual Plants

Reduced survival, growth, or reproduction

Wetland/ Riparian

Plants

Aquatic Invertebrates,

Vertebrates

Attribute

Changes

Receptors

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 Integument Uptake

Direct Contact/

Root Uptake

Exposure

Route

Receiving Water Body/Treatment Facility/ Sediment

Riparian/

Wetland Foliage/Soil

Source/

Exposure

Media

Wastewater flow/surface waters

Source/

Transport

Pathways

Cyphenothrin Used as Spot Treatment (Washing or Immersion in Surface
Water Body)

or “Down-the-drain’

Ingestion

Ingestion

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Media

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Aquatic Plants

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Stressor

Source

Receptors

Attribute

Change

Cyphenothrin applied to external home surfaces

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