UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM
PC Code: 129013
DP Barcode: D365379 December 15, 2009

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

TO: Joy Schnackenbeck, Chemical Review Manager Robert McNally, Risk Manager Special Review and Rere gistration Division (7509P)

FROM: Brian Kiernan, Biologist Cheryl Sutton, Ph.D., Environmental Scientist
Environmental Risk Branch 4
Environmental Fate a nd Effects Division (7507P)

REVIEWED
BY: Marietta Echeverria, Risk Assessment Process Leader Thomas Steeger, Ph.D., Senior Biologist
Environmental Risk Branch 4
Environmental Fate a nd Effects Division (7507P)

THROUGH: Elizabeth Behl, Chief
Environmental Risk Branch 4
Environmental Fate a nd Effects Division (7507P)

The Environmental Fate and Effects Divisi on (EFED) has completed the preliminary problem formulation (attached) for the ecologi cal 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 in formation 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 us ed during the completion of the ecological risk assessment in support of Registrati on Review. This document also recommends

Page 1 of 41studies that should be included in a generic data call-in (DCI) to address uncertainties surrounding the environmental fate and poten tial ecological eff ects of cyphenothrin.

Page 2 of 41

# 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)

P

repared by: Brian Kiernan, Biologist Cheryl Sutton, Ph.D., Environmental Scientist U. S. Environmental Protection Agency Office of Pesticide Programs

E nvironmental Fate and Effects Division

E nvironmental Risk Branch IV 1200 Pennsylvania Ave., NW

M

ail Code 7507P Washington, DC 20460 R eviewed by: Marietta Echeverria, Risk Assessment Process Leader Thomas Steeger, Ph.D., Senior Biologist Elizabeth Behl, Branch Chief

Page 3 of 41

## I. Purpose

The purpose of this problem formulation is to provide an understanding of the environmental fate and ecological effects of th e registered uses of cyphenothrin (PC Code 129013). Cyphenothrin is a pyrethroid este r insecticide used indoors (household/ domestic dwellings, storage areas, pet livi ng/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 su rface water contamination will be evaluated to account for the possibility of a treated an imal 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 cyphenothr in and for conducting environmental fate and ecological risk and endangere d species assessment s for its registered outdoor uses. Drinking water exposure will not be assessed si nce 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 ecologi cal risk associated with the regi stered 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 ( http://www.epa.gov/oppsrr d1/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 scient ific data and other f actors 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 policie s and practices change, all registered pesticides continue to meet the statutory standa rd of no unreasonable
adverse effects to human health and the enviro nment. Because change s in science, public policy and pesticide use practices will occu r over time, the Agency will periodically reevaluate pesticides to ensure that as change occurs, products in the marketplace can
continue to be used w ithout unreasonable risk.

As part of the implementation of the Regist ration Review program, pursuant to Section 3(g) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Agency is conducting an environmental fate and ecologi cal risk assessment to determine whether cyphenothrin continues to meet the FIFRA st andard for registration. This problem

Page 4 of 41formulation for the environmental fate and eco logical risk assessment chapter in support of Registration Review is intended for the in itial docket opening the public phase of the review process.



### B. Conclusions from Previous Risk Assessments

The Agency has not previously conducted an ecological risk asse ssment or a drinking water assessment for cyphenothr in since the chemical's us e 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 regi stered for use on horses in 2005 (Reg. No. 002517-0084) and dogs in 2006 (Reg. No. 002517-0080).

Page 5 of 41

## III. Stressor Source and Distribution

A. Mechanism of Action

Cyphenothrin, ( RS )- α -cyano-3-phenoxybenzyl (1 RS )- cis-trans -2,2-dimethyl-3-(2- methylprop-1-enyl)cyclopropanecarboxylate, be longs 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 rapi d paralysis that may be reversible and that may or may not lead to deat h), and some repe llent properties.

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



### B. Overview of Pesticide Usage

Currently, cyphenothrin is registered for spra y 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, an ts, flies, midges, yellow jackets (adult), small flying insects, cockroaches and other pests in domestic, public health and industrial situations. Available cyphenothrin use inform ation 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 pyret hroid, 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-gene ration pyrethroids) of synthetic pyrethroid compounds may photodegrade rapidly in sunlight (photolysis), with half-lives gene rally on the order of hours (Spurlock & Lee, 2008)

. Low water solubility (h ydrophobicity) 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 ha ve been submitted to EPA to support the registration of cyphenothrin. However, ava ilable nonguideline data defining the physical,

Page 6 of 41chemical, fate and transport characteristics associated with cyphenothrin are summarized
in Table 1 . These data were obtained from th e 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

K O W ; 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-lif e (days) No data
-- -- Aerobic aquatic metabolism half- life (days) No data
-- -- Anaerobic aquatic metabolism hal f-life (days) No data
-- -- Soil partition coefficients (K d ) No data
-- -- Organic-carbon normalized partition coefficients (K

oc ) (mL/g

oc ) 9,224 PPDB PPDB 6 July 2009 update

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

Page 7 of 41There are no data available on the bioc oncentration/bioaccumulation potential of cyphenothrin. The reported logarithm of th e octanol-water parti tion coefficient (Log

K ow ) for cyphenothrin is 6.29, which typica lly suggests a high potential for bioaccumulation. A preliminary analysis was conducted using the Agency’s PBT Profiler (http://www.epa.gov/pbt/to ols/toolbox.htm). This m odel, based on structuralactivity relationships, in dicates that cyphenothrin has proper ties 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 K
ow . The chrysanthemate moiety of first-generation pyrethroids is known to be sensitive to photodegradation (Spurlock and Lee 2008), an d 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 Do cument (USEPA 2004), the risk assessment for cyphenothrin will rely on a su rrogate species approach. Toxicological data generated from surrogate test species, wh ich are intended to be representative of broad taxonomic groups, are used to extrap olate to potential effects on a variety of species (receptors) included unde r these taxonomic groupings.

Acute and chronic toxicity da ta 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 terrestr ial receptors. This in cludes toxicity data on the technical grade active i ngredient, degradates, and wh en available, formulated products ( e.g . “Six-Pack” studies). Open literature studies are identified using EPA’s ECOTOXicology database (ECOTOX) (USEPA 2007 b ), 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 biot ic communities from loss of species that are sensitive to the chemical and from changes in structure and functiona l characteristics of
the affected communities.

Table 2 provides a summary of the taxonomic groups and the surrogate species tested to characterize the potential acu te and chronic ecological ef fects of cyphenothrin. In addition, the table provides a preliminary ove rview of the potential acute toxicity of cyphenothrin by providing the acute toxicity classifications.

Page 8 of 41

### A. Effects to Aquatic Organisms

Technical grade cyphenothrin is classified as very highly toxic to freshwater fish, aquatic-phase amphibians and freshwater aqua tic invertebrates on an acute exposure basis ( Table 2 ). No guideline studies on acute exposure to estuarine/marine organisms have been submitted. Effects of chronic expos ure to cyphenothrin on fish or aquatic invertebrates have not been submitted to suppor t risk assessment. No data on the effect of cyphenothrin on aquatic plan ts are available. In the absence of guideline toxicity studies or ECOTOX data for cyphenothrin, th e Agency will consider the potential for bridging data from similar pyrethroi ds 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 toxi city 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/r eevaluation/chemicals/ summary_ai_data_req. pdf ). The Agency will make use of all available reliable data in evaluating the potential risks associated with regist ered uses of cyphenothrin.



### B. Effects to Terrestrial Organisms

Cyphenothrin is categorized as practically nonto xic 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 informa tion 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 inse cts. No data are available with which to evaluate the toxicity of cyphenothrin to terrestrial plants. However, there several incidents of phytotoxicity associated withpermethrin (PC Code 109701), a similarlystructured pyrethroid, reporte d in the Environmental Incident Information System (EIIS)
database.

Page 9 of 41Table 2. Test Species Evaluated for A ssessing 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

Birds 1 Bobwhite quail ( Colinus virginianus ) LD 50 = NA
LC 50 >5,600 mg/kg diet -- 40983601 Practically
nontoxic

NOAEC = NA
LOAEC = NA ---

--- *

Mammals Laboratory rat ( Rattus norvegicus ) LD 50 =318 mg/kg 42436212 Moderately
toxic

NOAEC =NA
LOAEC =NA --

-- *

Insects Honey bee ( Apis mellifera L. ) NA
-- --

Terrestrial

plants 3 NA NA NA

Freshwater fish 2 Rainbow trout ( Oncorhynchus mykiss ) 96-hour LC 50 = 0.34 μg/L 41087502 Very highly
toxic

NOAEC = NA
LOAEC = NA --

-- *

Freshwater
invertebrates Water flea ( Daphnia magna ) 48-hour EC 50 = 0.43 μg/L 41087501 Very highly
toxic

NOAEC = NA
LOAEC =NA --

-- *

Estuarine/marine
fish NA NA NA

Estuarine/marine

invertebrates NA NA NA

Aquatic plants NA NA NA * Chronic Toxicity is not classified

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 monoc ots (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.

Page 10 of 41

### D. Ecological Incidents

A preliminary review of the Ecological Incident Information System (EIIS; 2007 a )) maintained by the Agency’s Office of Pes ticide Programs (OPP) i ndicates no incidents have been reported as of 07/22/2009. However, there are several incidents of phytotoxicity associated with permethrin (PC Code 109701), a si milarly-structured pyrethroid. Additionally, the lack of reported incidents canno t be construed as the lack of incidents. Since 1998, registrants are only re quired to submit detailed information to EPA on 'major' incidents (f or 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 mon itoring efforts due to lack of resources.

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

Reported pet incidents invol ving the use of cyphenothr in, from 10/2007-8/2009, include 71 mortalities, 73 major incidents, 2674 mode rate 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 incident s and 65% of minor incidents. These data are for cyphenothrin co-formulated with pyr iproxifen (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.



### E. Ecosystems Potentially at Risk

The ecosystems potentially at risk are often extensive in scope; therefore, it may not be possible to identify specific ecosystems dur ing 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 co rners and localized re sting 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 planting s, stream and pond edges.

Aquatic ecosystems potentially at risk incl ude 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 waterway s such as streams or rivers. In coastal areas, aquatic habitat also includes estuar ine areas. Wash-off from treated dogs and horses may result in surface water contamina tion, either through the animal’s immersion in the waterbody or as a result of wa shing pets that have been treated.

Page 11 of 41

## V. Assessment Endpoints

Assessment endpoints represent th e actual environmental value that is to be protected, defined by an ecological entity (species, comm unity, or other entity) and its attribute or characteristics (USEPA 1998). For cyphenothr in, the ecological en tities include the following: birds, reptiles, terrestrial-pha se amphibians, mammals, freshwater fish, freshwater aquatic-phase amphibians and in vertebrates, estuarine/marine fish and invertebrates, terrestria l plants, insects and aquatic plants. The attributes for each of these entities include growth, repr oduction, and survival.

Assessment endpoints for cyphenothrin, as well as all pesticides eval uated for ecological risk, include potential di rect 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 e ndpoint requires one or more “meas ures 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 eff ects 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 ris k, it must reach ecological receptors in biologically significant concen trations. 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 prov ides a written description and visual representation of the predicte d relationships between cyphe nothrin, potential routes of exposure, and the predicted effects for the assessment endpoint. Th e conceptual model consists of two major components: risk hypo thesis and a conceptual diagram (USEPA 1998).

Page 12 of 41

### A. Risk Hypothesis

A risk hypothesis describes the predicted relationship among the stressor, receptor exposure, and assessment endpoint response alo ng 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 (fro m pets), runoff, erosion of sedimentbound residues or spray drift leading to exposure of nontarget plants and animals. These potential exposure pathw ays may result in adverse effects upon the survival, growth, and/or reproduction of non-target terr estrial and aquatic organisms. These nontarget organisms ma y include Federally-listed threatened and endangered species.



### B. Conceptual Diagram

The known and/or estimated environmental fate properties of cyphenot hrin indicate that pet wash-off, runoff, erosion of sedime nt-bound residues and sp ray drift represent possible transport mechanisms of cyphenothrin to aquatic and terrestrial environments. Given the labeled outdoor uses of cyphenothr in (which generally limit applic ation to outside treatment of structures), and the dire ctions for squeeze-on spot treatments (which
state treated animals should not be washed immediately after treatment unless adverse reaction is observed), the like lihood and magnitude of resi due transport and receptor exposure is likely limited but remains uncer tain. 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 th e conceptual models below ( Figures 1, 2 and
3 ) and result in the movement of cyphenothr in into aquatic (water and sediment) and terrestrial (soil and foliage) habitats. The m ovement away from the site of application in turn represents exposure pathways for a broa d 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.

Page 13 of 41Figure 1. Conceptual model for potentia l risks of cyphenothrin to aquatic organisms. Dotted lines indicate exposure pathways that have a low likelihood of contributing to ecological risk. Cyphenothrin applied to external home surfaces

Spray drift

Fish/aquatic-phase amphibians Eggs

Larvae
Juveniles / Adults

Individual organisms
Reduced survival Reduced growth Reduced reproduction Food chain Reduction in algae Reduction in prey Habitat integrity Reduction in primary productivity
Reduced cover Community change Surface water/

Sediment Runoff

Aquatic Animals
Invertebrates
Vertebrates Uptake/gills or integument

Ingestion Ingestion Soil

Uptake/gills or integument

Aquatic Plants

N on-vascular
Vascular Uptake/cell, roots, leaves Riparian plant
terrestrial

exposure pathways see

Figure 2 Groundwater 

### Stressor

Source

Exposure
Media

Receptors

Attribute Change

Page 14 of 41

### Stressor

Source

Receptors

Attribute Change Cyphenothrin applied to external home surfaces

Spray drift

Birds / Terrestrialphase amphibians / reptiles /
mammals Terrestrial

insects

Individual organisms
Reduced survival Reduced growth Reduced reproduction Food chain Reduction in prey Habitat integrity Reduction in primary productivity
Reduced cover Community change Terrestrial/riparian plants grasses/forbs, fruit, seeds (trees, shrubs) Runoff

Mammals 

### Exposure
Media Soil

Ingestion Ingestion

Ingestion Ingestion Dermal uptake/Ingestion

Root uptake

Birds /

Am p hibians Ingestion

Figure 2. Conceptual model for potentia l risks of cyphenothrin to terrestrial organisms. Given the limited outdoor uses, no effort has been made to identify a single predominant route of terre strial exposure in this diagram.

Page 15 of 41Stressor Cyphenothrin Used as Spot Treatment (Washing or Immersion in Surface Water Body)
or “Down-the-drain’

Source/ Transport
Pathwa y s Wastewater
flow/surface waters

Source/ Exposure
Media Riparian/
Wetland Foliage/Soil Receiving Water Body/Treatment Facility/
Sediment

Exposure
Route Direct Contact/ Root Uptake Gill/ Integument

Uptake

Rece p tors

Attribute Changes Aquatic Invertebrates,
Vertebrates Wetland/ Riparian
Plants

Individual Plants Reduced survival, growth, or reproduction Individual
Vertebrates and
Invertebrates
Reduced survival or reproduction Aquatic
Plants Uptake/ Adsorption

Plant Population
Reduced population growth

Figure 3. Conceptual model for potent ial 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, e nvironmental fate, and ecological effects of cyphenothrin will be characterized and integrat ed to estimate risk. For screening-level assessments, this is accomplishe d using a risk quotie nt (ratio of exposur e concentration to effects concentration) approach. Although ri sk is often defined as the likelihood and magnitude of adverse ecologica l effects, the risk quotient approach does not provide a quantitative estimate of likeli hood and/or magnitude of an a dverse effect. However, as outlined in the Overview Document (USE PA 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 leve l of concern (discusse d below) or actual calculated risk quotient value.

Page 16 of 41This analysis plan will be revisited a nd may be revised depending upon the information submitted by the public in response to the ope ning 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 th e environmental fate of cyphenothrin or degradates that may form; fate data are be ing 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 re gistered for residen tial outdoor use, is formulated with the synerg ist N-octyl bicycloheptene dicarboximide, also known as MKG-264. According to the Registration Eligibility Decision (RED) for MKG-264 (http://www.epa.gov/pesticid es/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 cyphenothr in aerosol spray. However, the presence of a synergist may result in greater sensitivit y to the formulated product than is indicated by guideline studies on the technical product.

Evaluation of pesticide active ingredient mixt ures is beyond the scope of this assessment because of the myriad factors that cannot be quantified based on the available data.
Those factors include identif ication 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 characteristic s of the receiving waters ( e.g. organic matter present in sediment a nd suspended water). Evaluation of factors that could influence additive/synergistic effects is beyond the scope of the assessment. However, the Agency acknowledg es that not consider ing 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 fo rmulated 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 ba sed 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 an d public health uses). These models require environmental fate data as input. However, because the
outdoor uses assessed here are limited to small-scale, re sidential uses, exposure will be estimated to the best degree possible based on pot ential cyphenothrin use patterns, known

Page 17 of 41or estimated chemical properties ( e.g. , rapid photodegradation and hydrolytic stability), and toxicity. There are no m onitoring data for cyphenothrin.

For outdoor urban uses in general, it is assu med that runoff water from rain and/or lawn watering may move pesticide di rectly 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 de veloped for models used by O PP. Runoff in urban areas may be impacted by pesticides in runoff (water or sediment) or application to impermeable surfaces. Aquatic exposure m odeling will be conducted for the outdoor use of cyphenothrin (application to outdoor premis es, 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 resu lts from wash-off from spot-treatment of dogs or horses. Label language states that tr eated 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 r eaching surface waters, both from washing treated pets and from pets immersing in str eams, ponds or lakes. Possible evaluation of this type of exposure is laid out in detail in th e publically available Registration Review problem formulation for the pyret hroid 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 c onsidering that many spot treatments are designed to be absorbed by the pet, thereby providing extended prot ection. 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 wa ter column availability but increasing exposure to benthic invertebrates. In addition, there is the potential for microbial degradation within treatment fac ilities (from the Down-the-Drain assessment) that could further reduce cyphe nothrin concentrations prior to discharge. Environmental fate data for cyphenothrin are needed to better address these assumptions and
uncertainties.

For exposure to terrestrial organisms, spra y drift from outdoor applications may be intercepted by plant surfaces and forage it ems. The mass of cyphenothrin from a

Page 18 of 41conservative 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 th e application rate usi ng 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 be tter 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. Th e 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 chemi cal mixture toxicity da ta for aquatic life, terrestrial plants, and wildlife. ECOTOX wa s created and is maintained by the USEPA, Office of Research and Development, and th e National Health and Environmental Effects Research Laboratory's Mid-Con tinent Ecology Division (USEPA 2007 b ).

Where available, sublethal effects obser ved in both registrant-submitted and open
literature studies will be eval uated qualitatively. Such e ffects 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.

The assessment of risk for direct effects to non-target organism s 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 animal s in this screening-level assessment are the

LD 50 , LC 50 and EC 50 . LD stands for "Lethal Dose", and LD 50 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 LC 50 is the concentration of a chemical that is estimated to kill 50% of the test organisms. EC stands for “Effective Concentration” and
the EC 50 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. N OAEL stands for “No Observed-AdverseEffect-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. , “NoObserved-Adverse-Effect-Concentration”) is the highest test concentration at which none of the observed effects were statistically diffe rent from the control. For non-listed plants, only acute exposures are assessed ( i.e. , EC 25 for terrestrial plants and EC 50 for aquatic plants); for listed plants, either the NOAEC or EC 05 is used.

Page 19 of 41In the absence of data for either acute or chronic effects, cyphenothr in toxicity will be presumed. The absence of appropriate data will be especially problematic for the endangered species effects determinations a nd means of identifying mitigation that could potentially obviate such determinations.



### D. Integration of Exposure and Effects

Risk characterization is the in tegration of exposure and ecolo gical effects characterization to determine the potential eco logical risk from the use of cyphenothrin on porches,external home surfaces, and pets and the likelihood of direct and indirect effects to nontarget organisms in aquatic and terrestrial hab itats. The exposure and toxicity effects data are integrated in order to evaluate the ri sks of adverse ecological effects on non-target species. For the assessment of cyphenothrin risk s, the risk quotient (RQ) method will be used to compare exposure and measured toxi city values. In this approach, EECs are divided by acute and chronic to xicity values. The resulting RQs are then compared to the Agency’s levels of concern (L OCs) (USEPA 2004). These crit eria are used to indicate when cyphenothrin use, as directed on the labe l, have the potential to cause adverse direct or indirect effects to non-targ et organisms. As noted prev iously, where data are lacking on the toxicity of cyphenothr in, risk will be presumed.

The quantitative assessment of risk will pr imarily depend on the deterministic pointestimate based approach described in the risk assessment. An effort will be made to further qualitatively describe risk using probabi listic tools that the Ag ency has developed. These tools have been reviewed by FIFRA Sc ientific Advisory Panels and have been deemed as appropriate means of refining a ssessments 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 th reatened and/or endangered (listed) species from registered uses of cyphenothrin. Th is 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 asso ciated 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 exceedan ce 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 Do cument (USEPA 2004) c onsiders the results of the risk assessment proce ss to establish boundaries fo r that action area with the understanding that exposures below the Agency’s defined LOCs constitute a no-effect threshold. For the purposes of this assessmen t, attention will be focused on the footprint of the action ( i.e. , the area where cyphenothr in application occurs), plus all areas where offsite transport ( i.e. , wash-off, spray drift, runoff of sediment-bound residues (erosion),

Page 20 of 41etc .) 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 mo dification of its critic al 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 w hole 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 spatia lly 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. Ba sed 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 essentia lly nonexistent. To date, no environmental fate studies have been submitted for this compound. Based on 40 CFR Part 158, Subpart N (revised Ju ly 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 t hose compounds may be sensitive to photodegradation, additional data are require d for aqueous photolysis a nd are requested for soil photodegradation. Additionally, anaerobic so il metabolism data are recommended to more fully characterize the environmental fa te 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 cyphenothri n. The environmental fate data gaps are listed in Table 3

.

Page 21 of 41Table 3. Available environmental data fo r 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 expect ed to have a significant impact on the exposure assessment, particularly with regard to aquati c 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 discusse d previously, in the absence of data to the contrary, any identified major degradates will be presumed to be as toxic as the parent. More th orough rationales regarding the n eed 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 regard ing 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.

Page 22 of 41Data should also be submitted for acute effect s to estuarine and marine animals. These data are conditionally required for reside ntial outdoor pesticide uses. Because cyphenothrin is very highly toxic to aqua tic animals on an acute exposure basis, and because some pyrethroids exhibit greater toxi city 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 toxici ty of cyphenothrin to wildfowl, upland game species and to passerines due to the outdoor us e. Additionally, data are needed regarding the reproductive effects of chronic exposure of birds to cyphenot hrin. Data on the subacute dietary toxicity of cyphe nothrin 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 l east a Tier I phytotoxi city study for all pesticides with outdoor uses. Given the re ported 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 exp ected to occur. Although currently risk
assessments are not conducted for terrestrial i nvertebrates, 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 to xicity of cyphenothrin to the aquatic-phase of insects. These data are generally from a ggregate studies on pyrethroids in general and conducted on target species. Therefore, th e submission of guideline data for honey bees
is recommended.

Additionally, CFR 40 Part 158 states that if ’an ingredient othe r than the active ingredient is expected to enhance the toxi city 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.

Page 23 of 41Table 4. Available ecological effects da ta 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

Page 24 of 41Table 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 No 1

Required under CFR 40 Part
158

1 However, data on the formulated product should be
submitted

2 An acute to chronic ratio may
be used

3 Cyphenothrin from spottreatment 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

No 1 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 No 2

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 No 2

850.1735 Whole sediment:
acute freshwater

invertebrates No data * NA Yes 3

*Conditionally required for cyphenothrin

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

Guideline Description MRID Classificatio

n 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

Page 25 of 41

## VIII. References

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

Hoerger, F. and E. E. Kenaga, 1972. Pes ticide 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. Synt hetic pyrethroid use pa tterns, properties and environmental effects. In: Synthetic Py rethroids, Occurrence and Behavior in Aquatic Environments. J. Gan, F. Spur lock, 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. http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759

U.S. Environmental Protection Agency. 2000. Risk Characterization Handbook. Science Policy Council, U.S. Environm ental 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 Threat ened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D. C. January 23, 2004. 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 Asse ssments Conducted in the Environmental
Fate and Effects Division. Office of Pesticide Programs, Washington, D.C. January 24, 2005. http://www.epa.gov/oppefed1/ecorisk_ders/index.htm#framework

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

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

Page 26 of 41U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS). 1998. Endangered Species C onsultation 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 Wate r Quality Assessment (NAWQA) program. Accessed 8 January 2008. 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. Spurloc k, P. Hendley, D. Weston, editors ACS Symposium Series 991. pp 310-334.

Page 27 of 41Appendix 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,CH T,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). Hi stopathological 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).

Page 28 of 41Rani, 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)-alphaCyano-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). Eff ect of Pyrethroids on Pentobarbital-Induced Sleeping
Time in Relation to th e 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,PM R,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).

Page 29 of 41Acceptable to EcoTox but not OPP

Abe, Y., Senbo, S., Takada, Y., Kawada, H., and Ito, T. (1994). The Ef fectiveness 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 Cutwor m, Spodoptera litura Fabricius. J.Pestic.Sci.(Nippon Noyaku Gakkaishi) 9: 481-487.

EcoReference No.: 112900 Chemical of Concern: FPP,FN V,CYP,PMR,CHT,SMT,HCCH,FNT; Habitat : T; Effect Codes : MOR,PHY; Rejection Code : NO CONTROL(CHT,SM T,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, Blatte lla 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),T ARGET(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

Page 30 of 41Code : 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: Co mparison 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 Pyreth rum 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 Resist ance 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).

Page 31 of 41Lindsay, 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., O kuno, Y., and Yoshioka, H. (1983). New Pyrethroid Insecticides for Indoor Applications. In: J.Miyamoto and P.C.Ke arney (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 Rosi n-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 Evalua tion 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 Vari ous Microcapsule Sizes and Applied on Porous and Non-porous
Surfaces. Pest Manag.Sci. 65: 93-98.

Page 32 of 41EcoReference 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 Xenobio tics 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,DDV P,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 Re flex 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).

Page 33 of 41Appendix 2 Down-the-Drain Scenario for Pet Spot Treatments from the Etofenprox Registration Review Problem Formulation

Document available at ( http://www.epa.gov/oppsrr d1/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 b een treated with etofenprox as a preventative spot treatment. EECs are estimated using multiple conserva tive 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% et ofenprox, a specific gravity of 1.062, and a treatment volume of 2 ml, the amount of et ofenprox in one treatment is about 1.17 g. Based on the Down-the-Drain compone nt of the E-FAST model, the 50 th percentile per capita daily indoor water usage is 388 L pe r 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 ( μ g/L). However, this estimated c oncentration 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 th e estimated etofenprox calculation using this water usage es timate yields an EEC of 424 ppb.

In a typical 50,000 person municipality, the num ber of cats that must be washed on a given day to equal the endange red 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 municipa lity 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

Page 34 of 41untreated wastewater to exceed the listed species acute risk LOC.

As stated above, this approach incorporat es several conservative assumptions. The
assessment method assumes that 100% of the etofenprox applied to cats is removed during pet washing. This is a conservativ e assumption considering that many spot treatments are designed to be absorbed by th e 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 se diments or other solids thereby reducing availability. In addition, ther e is the potential for microbial degradation within treatment
facilities that would further reduce etofenprox concentrations . Environmental fate data for etofenprox is needed to better addr ess these assumptions and uncertainties.

Page 35 of 41Appendix 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 requi red 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 poten tial risks from cyphenothrin to aquatic invertebrates, freshwater fish and aquatic-pha se 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 th e scope of sublethal effects and potential chronic risks to freshwater aquatic wildli fe 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 d ecision or impact the Agency’s future decision-making? If future endangered species risk assessments are performed without th ese 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 wh ere 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 an d could result in use restrictions for cyphenothrin use that are unnecessarily severe.

Guideline Number: 850.1735 Study Title: Whole Sedimen t: Acute Freshwater Invertebrates Rationale for Requiring the Data

Acute toxicity to sediment-dwelling inverteb rates data are conditionally required under 40 CFR Part 158 (2008) data requirements for pestic ides with residential outdoor uses. Since cyphenothrin is expected to partition to se diments and may bioaccumulate in the aquatic food chain, these data are necessary to determ ine if cyphenothrin may adversely affect the survival, growth or reproduction of aquatic invertebrates and, indi rectly, higher trophiclevel organisms. Practical Utility of the Data
How will the data be used? These data are necessary to characterize the poten tial risks from cyphenothrin to aquatic

Page 36 of 41invertebrates, freshwater fish and aquatic-pha se amphibians (for which the fish serve as surrogates) and other higher trophic -level species. The available acute toxicity data indicate that cyphenothrin is very highl y 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 d ecision or impact the Agency’s future decision-making? If future endangered species risk assessments are performed without th ese 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 wh ere 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 an d 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 da ta requirements specify that av ian 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 av ian 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 cyphenothr in. 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 th ese data, the Agency would have to assume that cyphenothrin “may af fect” listed birds direc tly (and listed species from other taxa indirectly), and use of cyphenot hrin and its formulated products may need to be restricted in areas where listed species coul d 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

Page 37 of 41outdoor uses. The Part 158 data requirements specify that avian repr oduction 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 da ta for mallard ducks and bobwh ite quail will be used in the screening-level assessment to determine whet her there are effects on birds from chronic exposure to cyphenothrin. If reproductive toxi city 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 assessmen ts are performed wit hout these data, the Agency would have to assume that cyphenothr in “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 an d 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 pot ential 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 othe r beneficial insects wi ll be presumed. If endangered species risk assessments are perf ormed 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 restrict ed 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

Page 38 of 41Data regarding the toxicity of cyphenothrin to terrestrial plan ts have not been submitted to the Agency. These data are required under th e 40 CFR Part 158 (2008) data requirements for pesticides with outdoor uses. These da ta are necessary to determine whether the outdoor use of cyphenothrin could adve rsely affect terrestrial plants. Practical Utility of the Data
How will the data be used? These data will be used to determine the pot ential 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 w ill be assumed. Because plants are primary producers, providing the foundation of food sources for all animal spec ies and habitat for most, the lack of these data may require the Agency to presum e 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-targ et plants and indirect risk to all animal species from use of cyphenothrin. Therefor e, 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 an d 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 cyphe nothrin are required under 40 CFR Part 158, Subpart N (revised July 1, 2008) for labeling th at includes residentia l outdoor uses. The Agency has a limited understand ing 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 wi ll be used to help characterize and quantify the environmental fate of cyphenothrin a nd any potential degradates in aquatic environments. For quantitative exposure estimation, these data will be used in modeling estimated environmental concentrations (EEC s) of cyphenothrin for the aquatic exposure

assessment.

How could the data change the Agency’s d ecision, or impact the Agency’s future decision-making? In the absence of the requested data, cyphe nothrin will be assumed to be stable to hydrolysis. This assumption will constitute an uncertainty in the risk assessment. Additionally, the identity of a ny potential degradates that coul d be of toxic concern would
remain an unknown.

Page 39 of 41Guideline Number: 835.2240 Study Title: Photodegradation in Water Rationale for Requiring the Data Acceptable data on the photodegradation of cy phenothrin 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 c yphenothrin. Because cyphenothrin is known to be photolabile, it is required that the photoproducts be identif ied to fully characterize the environmental fate of this compound. Practical Utility of the Data
How will the data be used? Currently there are no photodegr adation 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 pot ential degradates in aquatic environments. For quantitative exposure estimation, these data will be used in modeling estimated environmental concentrations (EECs) of cyphenot hrin for the aquatic e xposure assessment.

How could the data change the Agency’s d ecision, or impact the Agency’s future decision-making? In the absence of the requested data, cyphe nothrin will be assumed to be stable to photodegradation. This assumption will constitute an uncertainty in the risk assessment. Additionally, the identity of a ny potential degradates that coul d 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 wi ll 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 cyphenot hrin for the aquatic e xposure assessment.

How could the data change the Agency’s d ecision or impact the Agency’s future decision-making? In the absence of the requested data, cyphe nothrin will be assumed to be stable to microbial metabolism in soil. This assumption will constitute an uncertainty in the risk

Page 40 of 41Page 41 of 41 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 adsorpti on/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 cyphe nothrin 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), th en adsorption/desorption data on the major degradate(s) should also be submitted.

How could the data change the Agency’s d ecision or impact the Agency’s future decision-making? In the absence of the requested data, the pot ential leaching behavior of cyphenothrin will be an unknown, and will constitute an uncertainty in the risk assessment.