Page 1 of 21 UNITED STATES E NVIRONMENTAL PRO TECTION AGENCY WASHINGTON D.C., 20460

Date: October 20, 2014 PC Code: 047201 DP Barcode: 419153

MEMORANDUM

Subject: Registration Review –Preliminary Ecological Risk Assessment and Endangered Species Effects Determination for Dipropyl isocinchomeronate (aka Morpel ® Repellent 326, formerly MGK ® Repellent 326)

To: Marianne Mannix, Chemical Review Manager Patricia Parrott, Branch Chief Risk Management and Implementation Branch III Pesticide Re-evaluation Division

From: Melanie Biscoe, Physical Scientist Katherine Stebbins, Biologist Environmental Risk Branch 3 Environmental Fate and Effects Division

Reviewed Melissa Panger, Ph.D., Senior Scientist By: Environmental Risk Branch 3 Environmental Fate and Effects Division

Through: Dana Spatz, Branch Chief Environmental Risk Branch 3 Environmental Fate and Effects Division Office of Pesticide Programs

The Environmental Fate and Effects Divisi on (EFED) has completed the preliminary ecological risk assessment and endangered species effects determination for the registration review of the insect repellant , dipropyl isocinchomeronate (formerly MGK ® Repellent 326 or MGK-326, her eafter referred to as Morpel ® ) (PC code 047201; CAS: 136-45-8). An evaluation of potential risk to aquatic and terrestrial organisms as a result of the use of Morpel ® is summarized below.Page 2 of 21 Morpel ® is an insect repellent used in huma n and domestic animal insect sprays (specifically for dogs, cats and horses), lotions, ready-to-use wipes, and a dog and cat dip. Morpel ® sprays are also used in indoor premises. Morpel ® is never used as the sole active ingredient; rather, it is used to br oaden the spectrum of repellency of other formulation components, such as DEET (N,N -diethyl-m-toluamide) (PC code 080301), to repel flies, gnats, and other flying and biting insects.

Because of Morpel ® ’s very low use diffused over a larg e treatment area, as well as the low probability of non-target organism exposure to Morpel ® , EFED presented an analysis of the preliminary “no effect” determination for the registered uses of Morpel ® to the OPP Science Policy Council/Risk Management Forum’s De Minimis Subgroup (DMS). The DMS concurred with the ‘no effect’ de termination and recommended that EFED prepare an abbreviated ecological risk assessment for Morpel ® to present the conclusion of no unreasonable adverse eff ects to non-listed species, and no reasonable expectation of effects to federally listed thre atened or endangered species ( De Minimis Subgroup Opinion on Morpel ® , May 14, 2014). This prelimin ary ecological risk assessment presents data and results comparable to those presented to the De Minimis Subgroup along with additional supporting information re lated to the active ingredient (a.i.).

The results of this assessment on currently registered Morpel ® uses indicate that there are no level of concern (LOC) exceedances to listed or non-listed fish or aquatic invertebrates, and no reasonable expectation of effects to birds, reptiles, amphibians, mammals and plants. The EPA makes a No E ffects (NE) determination for all Federallylisted species and a No Habitat Modification determination for all designated critical habitats for the currently registered uses of Morpel ®

. Conclusions regarding aquatic animals are based on lack of acute LOC exceedances in the risk estimation. RQs were not calculated fo r aquatic plants as toxicity data were not available; however, based on the large marg in of safety observed for other aquatic taxonomic groups and toxicity estimates from structure activity relationship modeling, direct risk to aquatic plan ts are not expected. In add ition, there are currently no known incidents involving Morpel ® and aquatic organisms.

Conclusions regarding terrestrial organisms a nd plants are based on th e low probability of exposure to non-target organisms. For exampl e, exposure in terrestr ial habitats is not expected as the products form ulated as lotions or impre gnated wipes would be applied directly to the skin/animal and spray products would likely be applied at distances of less than 10 inches from the intended applicati on sites (human skin/dog, cat, horse skin and hair). Thus, exposure to terr estrial organisms is not expe cted because they would not likely come in close contact with humans or domestic animals 1 ( i.e., the registered use sites). Even if a non-target organism was to come into contact with Morpel ® from overspray or through contaminated food items, the exposure levels would be expected to be low. Therefore, given its low toxicity prof ile (for terrestrial animals), effects to non-

1 Throughout this assessment, the term “domestic animals” is defined as dogs, cats, and horses because they are the specific use site on the label.Page 3 of 21 target organisms would not be anticipated to exceed concern levels even if exposure occurred.

Data are not available to asse ss the risk to non-target terrest rial invertebrates; however, given that Morpel ® is an insect repellent (that is also co-formulated with repellents and/or toxicants), the potential exposure is likely only due to chance ( e.g., flying through the 10 inch spray directed at the human/horse or landing on the human/ horse). Additionally, Morpel ® is expected to remain on the target ( i.e., it is not expected to volatilize) and the repelling action of the formulated active ingred ients is expected to reduce the magnitude and duration of exposures. Exposure to terrestrial plants is not expect ed; thus, there is no risk expected for plants.

1. PROBLEM FORMULATION

Conclusions from Previous Risk Assessments

EFED has not conducted any ecological risk assessments for Morpel ® . The Re-registration Eligibility Document (RED) for dipropyl isocinchomeronate, signed September 23, 2003, stated that:

The Agency did not conduct an environm ental risk assessm ent because MGK ® Repellent 326 is an “indoor residential” use pesticide and MGK ® Repellent 326 is not likely to result in exposures and risks to non-target organisms.

While Morpel ® was previously classified as an “i ndoor residential” pesticide because of the limited potential to reach aquatic and te rrestrial environments, this assessment will consider potential exposures that may o ccur from product applic ations outdoors, from people and domestic animals being outdoors subs equent to application, and from release of contaminated household wastew ater into the environment.

Nature of Chemical Stressor

Morpel ® is never used as the sole active ingredie nt (a.i.); rather, it is used to expand the spectrum of repellency/efficacy of other fo rmulation components (such as DEET and NOctyl bicycloheptene dicarboximide). The mode of action for repellency is unknown, however, in some cases it is used for im proving the repellency of DEET products by preventing evaporation 2

. Morpel ® repellent products are formulated as em ulsifiable/soluble concentrates, ready to use spray/pressurized liquids, and as impregnated materials (towelettes). Table 1 provides a summary of the types of re gistered products. For humans, Morpel ® may be applied via spray/aerosol mist and towelettes. For domestic animals, applications may be

2 Brassard, D., Haddad, S., Ranville, M. BEAD Chemical Profile (BCP) for Registration Review: Dipropyl isocinchomeronate (PC Code 047201). April 28, 2014.Page 4 of 21 made as a spray, wipe-on, or towelettes. Additionally, for dogs and cats, Morpel ® may be applied via a pet dip application. The ready-to-use products for human use are formulated at or below a concentration of 2.5% a.i. by weight. The dip products for cats and dogs are sold as a concentrate (1.94-4% a. i.) which is diluted prior to use. Other spray (ready-to-use and concentrated) and wipe-on products for domestic animals are formulated at or below a concentration of 2.5% a.i. by weight. There are currently 40 registered products for Morpel ®

.

Table 1 provides information on the 11 registrati ons that represent the range of Morpel ® end-use products. Three of these 11 produc ts were used to calculate EECs for Morpel ® because they were expected to result in the highest environmental exposures and are listed in bold in the table.

Table 1. Representative Uses for MORPEL

Product For Use On... EPA Reg. Number % Active Ingredient Formulation Type Product container size

Towelette horses 10088-97 1.76 Impregnated Materials Towelette

Dip dogs and cats 2382-89 4.0 Soluble Concentrate 1 gallon (concentrate)
Wipe-on horses 270-253 0.5 Ready-to-Use Solution Not specified

Spray mist dogs, cats, horses 270-300 1.0 Ready-to-Use Solution Not specified
Dilute, then
spray dogs, cats, horses 270-301 2.5 Emulsifiable Concentrate Not specified
Dilute, then
spray horses 270-326 2.5 Emulsifiable Concentrate Not specified

Spray dogs, cats, horses 270-343 0.5 Ready-to-Use Solution 16 fl. oz.

Ear lotion dogs, cats, horses 270-345 1.0 Ready-to-Use Solution Not specified
Dip dogs and cats 270-349 1.94 Soluble Concentrate Not specified Wipe-on/Spray mist horses 40322-2 1.17 Ready-to-Use Solution 32 fl. oz.

Spray Human and horse use 54287-13 2.5 Ready-to-Use Solution Not specified

Spray human use 7754-41 2.5 Ready to UseAerosol 12 oz. canPage 5 of 21 Exposure Characterization

The structure and physicochemical characteristics of Morpel ® are summarized in Table 2 . Based on its vapor pressure, Morpel ® is not expected to volatilize under field conditions. Because of its limited use pattern, the only environmental fate study required to be conducted for Morpel ® was hydrolysis. Morpel ® remains stable under acidic conditions, as no degradation was observed at pH 5 during the 30 days of the hydrolysis study. However, Morpel ® hydrolyzes in neutral (pH 7 ha lf-life=17 days) and alkaline environments (pH 9 half-life=14 hours) (MRID 43073601).

Table 2. MORPEL: Structure & Physicochemical Properties

Parameter Value

Structure

Molecular formula C 13 H 17 NO 4 Molecular weight 251.3 g/mol Water solubility 892 mg/L at 20 o C Vapor pressure 4.92 x 10 -7 mm Hg at 25°C Octanol-water partition coefficient (log P ow ) 3.567 Melting Point n/a – liquid at room temperature Boiling Point 150 o C Dissociation constant (K a ) 0.119 at 25°C

Residues of Concern

Based on the hydrolysis study (MRID 43073601), Morpel ® produces three degradates:

 5-propyl, 2,5-pyridine dicarboxylate (35% of the total applied, day 30, pH 7)

 2-propyl, 2,5-pyridine dicarboxylate (33.1% of the total applied, day 30, pH 7)

 2,5-pyridine dicarboxylate (95% of the total applied, day 14, pH 9 only)Page 6 of 21 Toxicity data for the transformation pr oducts have not been submitted, and this assessment assumes that the degradates are to be equal or less t oxic than the parent compound. In this assessment, exposures are estimated under the conservative assumption that Morpel ® does not degrade in the environment. This assumption addresses any potential concerns regarding exposure of non-target organisms to Morpel ® degradates in the environment.

Ecological Effects

The most sensitive endpoint for each taxon is used for risk estimation. For this assessment, evaluated taxa include freshw ater fish (surrogate for aquatic-phase amphibians), freshwater invertebrates, birds (surrogate for terrestrial-phase amphibians and reptiles), and mammals. Table 3 provides a summary of the taxonomic groups and the surrogate species tested to characteri ze the potential acute and chronic ecological effects of Morpel ® . In addition, the table provides a preliminary overview of the potential acute toxicity of Morpel ® by providing the acute t oxicity classifications.

Table 3. Test Species Evaluated for Asse ssing Potential Ecological Effects of MORPEL and the Associated Acut e Toxicity Classification.

Taxonomic

Group Study Type Tested Species Toxicity Endpoint Toxicity Classification Study MRID and Classification

Birds Acute Oral Bobwhite quail ( Colinus virginianus ) LD 50 =1560 mg/kg- bw Slope: 4.3 Slightly toxic 41882601 (Acceptable)

Avian Subacute (5-day dietary) Bobwhite quail ( Colinus virginianus ) LC 50 = 5,000 mg a.i./kg diet Practically nontoxic 41685502 (Acceptable)

Mallard duck ( Anas platyrhyncos ) LC 50 = >5,620 mg a.i./kg diet No mortalities. NOAEC=3160 mg a.i./kg diet based on reduced body weight gain at 5630 mg a.i./kg diet. Practically nontoxic 41685501 (Acceptable)

Mammals Acute (oral)

Laboratory rat ( Rattus norvegicus ) LD 50 =5120 mg a.i./kg (male and female) Practically nontoxic 00155068 (Acceptable) 3

Chronic (2 generation) NOAEL=65 mg a.i./kg/day Based on decreased pup body weight on lactation days 14- 21 at 250 mg a.i./kg/day -- 41547801 (Acceptable) 3Page 7 of 21 Taxonomic

Group Study Type Tested Species Toxicity Endpoint Toxicity Classification Study MRID and Classification

Freshwater fish 2 Acute Bluegill Sunfish ( Lepomis macrochirus ) LC 50 =0.44 mg a.i./L NOAEC= 0.17 mg a.i./L based on signs of toxicity at doses ≥ 0.32 mg a.i./L 42174501 (Acceptable) Highly toxic

Rainbow trout ( Oncorhynchus mykiss ) LC 50 =1.0 mg a.i./L Slope= 14 NOAEC= 0.68 mg a.i./L based on signs of toxicity and mortality at doses ≥ 1.5 mg a.i./L 41911401 (Acceptable) Highly toxic

Freshwater invertebrates Acute Daphnid ( Daphnia
magna ) EC 50 =18 mg a.i./L Slope =8 Slightly toxic 41525302 (Acceptable)

1 Birds are considered surrogates for terr estrial-phase amphibians and reptiles.

2 Freshwater fish are considered su rrogates for aquatic-phase amphibians.

3 Study classification made by Health Effects Division (HED).

For aquatic organisms, data are available for freshwater fish and i nvertebrates on an acute exposure basis. Morpel ® is classified as “highly toxic” to fish [Bluegill ( Lepomis macrochirus) LC 50 = 0.44 mg a.i./L] and “slightly toxic” to invertebrates [Daphnid ( Daphnia magna ) EC 50 =18 mg a.i./L). Toxicity data we re not available for evaluation of chronic exposure to fish and invertebrates. Additionally, data were not available for vascular and non-vascular aquatic plants. However, the ECOSAR (structure activity analysis) predicted toxicity values for green algae as well as the chronic toxicity values for fish and aquatic invertebrates were within the toxicity values from the submitted data for aquatic taxa, thus, in this analysis, the acute endpoints serve as a pr oxy in the absence of data. See Appendix B for ECOSAR output.

On an acute oral exposure basis, Morpel ® is classified as “slightly toxic” to birds [LD 50 = 1560 mg a.i./kg-bw] and based on dietary exposure, Morpel ® is classified as “practically non-toxic” [5-day dietary LD 50 value = 5,000 mg a.i./kg diet]. For mammals, Morpel ® is classified as “practically nontoxic” on an acute exposure basis [acute oral LD 50 = 5,120 mg a.i./kg-bw]. On a chronic expos ure basis, the reported NOAEL of 65 mg a.i./kg/day was based on a decrease in pup body weight at the 250 mg a.i./kg/day treatment level. Chronic data are not available for birds.

Morpel ® toxicity data are not available for bees, non-target insects, or terrestrial plants. In an attempt to gain a better understanding of the toxicity to terres trial invertebrates, several efficacy studies were reviewed (MRIDs: 47390700, 46580201, 46106200,Page 8 of 21 00067102, 00115944), however, the interpretation wa s complicated because the products tested were often co-formulated with other active ingredients and re pellency (rather than toxicity) was generally the focu s of the studies, thus, no further information was gained.

Open Literature

A query of the open literature via the Web of Science Database was conducted for “MGK326”,“dipropyl isocinchomeronate”, and “Morpe l”. No studies condu cted for ecological effects were reported.

Conceptual Model

For a pesticide to pose an ecological risk, it must reach ecological receptors (a biological entity) that is exposed to a stressor (USEPA, 1998a) in biologically significant concentrations. An exposure pathway is th e means by which a pesticide moves in the environment from a source to an ecological r eceptor. For an ecological pathway to be complete, it must have a source, a releas e mechanism, an environmental transport medium, a point of exposure for ecological r eceptors, and a feasible route of exposure.

Risk Hypotheses

For the Morpel ® national-level ecological risk assessment, the following ecological exposure and risk hypotheses are being employed:

1) Morpel ® , when used in accordance with current labels, can result in offsite movement of the compound via wash-off by treated individuals entering water bodies as well as fr om showering/bathing and pet dips leading to exposure of non-target aquatic plants and animals including federally-listed threatened and endangered species.

2) Based on the proposed use patterns and the sensitivity of non-target aquatic species, the proposed uses of Morpel ® have the potential to reduce survival, reproduction, and/or growth in aquatic animals and plants through off-site movement of the compound via wash-off by treated individuals entering water bodies as well as from showering/bathing and pet dips le ading to exposure of non-target aquatic plants and animals (including federally-listed threatened and endangered species).

3) Direct applications of Morpel ® to human skin and domestic animals are not expected to result in significan t exposure to non-target terrestrial plants and animals including fe derally-listed threatened and endangered species.

Wash-off from treated individua ls by swimming, bathing, and pet dips may result in the movement of Morpel ® into aquatic environments (water and sediment). Based on the usePage 9 of 21 characteristics, runoff, spray drift, leachi ng, and atmospheric depos ition are unlikely to result in aquatic or terrestrial exposures to non-target plants and organisms. For Morpel ®

, the potential exposure pathways include wash -off from skin when treated individuals enter water bodies ( e.g., for recreation), wash-off from treated humans or pets into household wastewater (and subsequent releas e into the environment), and inadvertent release of pet dip into household wastewater (and subs equently into the environment) during the dipping process.

Exposure in terrestrial habitats would be limited to huma n skin as well as domestic pet skin and hair. Products formulated as lotio ns or impregnated wipe s would be applied directly to the human skin. Many other product labels specify recommended spray distances of less than 10 inch es from the intended applica tion sites (human skin/horse skin and hair). Any movement away from the site of app lication represents potential exposure pathways for a broad range of bi ological receptors of concern (non-target terrestrial animals and plants), however, the amount of Morpel ® resulting from human or pet applications in the terrest rial environment (air, ground, dr inking water, plants, or nontreated animals) is considered negligible.

Analysis Plan

In order to address the ri sk hypothesis, the potential for adverse effects on the environment is estimated. The use, environm ental fate, and ecological effects of Morpel ® are characterized and integrated to assess the risks. This is accomplished using a risk quotient (ratio of exposure concentration to effects concentration) approach.

Measures of Exposure

Aquatic ecosystems potentially at risk from Morpel ® exposure include (1) water bodies entered by treated humans or horses, as well as any water bodi es adjacent to, or downstream from the water bod ies entered, and (2) water bod ies into which domestic wastewater is ultimately released.

Measures of aquatic exposure are typically based on models that predict estimated environmental concentrations (EECs) of Morpel ® such the Pesticide Root Zone Model/Variable Volume Water Mode l (PRZM/VVWM) and Surface Water Concentration Calculator (SWCC) Graphic Us er Interface (GUI). Because of the limited application methods (directly to human/domestic pet skin/hair), the typical models used for exposure estimation will not be used in this assessment. Additionally, because limited laboratory fate data are available for Morpel ® , this assessment assumes that Morpel ® does not degrade in the environment.

It is assumed that Morpel ® reaches surface water when treated humans or horses enter a water body and the applied Morpel ® is washed off, remaining in the water column. Water concentrations are estimated under the assump tion that 100% of the applied a.i. (from 10 or 100 treated adults or 10 hor ses) is diluted in the sta ndard farm pond on a single day. Additionally, water concentra tions are estimated under the assumption that 50 cans ofPage 10 of 21 product are diluted in the standa rd farm pond on a single day.

Given the small size of the modeled water body, 10 and 100 swimming adults and 10 horses represent low, moderate, and high aqua tic exposures, respectively. Application of the equivalent of 50 cans of product repres ents a highly unlikely, very conservative aquatic exposure scenario. The scenarios chosen are intended to evaluate the plausibility of exposure levels approaching those that ma y cause concern for aquatic organisms.

It is also assumed that Morpel ® reaches surface water through local wastewater systems when humans or pets bathe, or when ther e is inadvertent releas e of pet dip down the household drain. Water concentrations ar e estimated using th e Exposure and Fate Assessment Screening Tool’s (E-FAST v.2.0) Down-the-Drain module, which may be accessed at http://www.epa.gov/oppt/exposure/pubs/efast.htm . Additionally, water concentrations are estimated using a more conservative approach of diluting several gallons of pet dip concentrate or several ga llons of pet dip that is diluted per label instructions into a single 1–hectare wate r body. Applying several gallons of dip concentrate or dip solution to the farm pond re presents an extremely conservative screen for aquatic exposures.

Because of the application method and limited scope of use sites for Morpel ® , terrestrial ecosystems potentially at risk are limited to the area in which treatment occurred ( e.g., spray application to human or horse). For this assessmen t, exposure to non-target terrestrial organisms via cont act with humans/horses or th rough overspray is presumed negligible and will not be estimated.

Measures of Effect

Measures of effect are obtained from a suite of registrant-submitted guideline studies that were conducted with a limited numb er of surrogate test species ( Table 3) . Toxicity data generated using surrogate test species, whic h are intended to be re presentative of broad taxonomic groups, are used to infer potential effects on a variety of species (receptors) included under these broade r taxonomic groupings. Birds represent surrogates for terrestrial-phase amphibians and reptiles, a nd freshwater fish represent surrogates for aquatic-phase amphibians. No additional non- target ecotoxicity da ta are available on Morpel ®

. Integration of Exposure and Effects

Exposure and toxicity data ar e integrated in order to evaluate the risks of adverse ecological effects on non-target species. For the screeni ng-level risk assessment of Morpel ® , the deterministic risk quoti ent (RQ) method is used to assess risk to aquatic organisms by comparing the estimated expos ure concentrations with the measured toxicity values. The RQ method involves di viding point estimates of environmental concentrations by acute and chr onic toxicity values . The resulting unit less RQs are then compared to the Agency’s Levels of Concern (LOC) ( Table 4 ). These criteria are used to indicate when applications of Morpel ® , as directed on the proposed labels, have thePage 11 of 21 potential to cause adverse effects to listed and non-listed non-target organisms. The risk to terrestrial organisms is considered qua litatively given the limited potential for
exposure.

Table 4. Agency Acute Risk Quotient (RQ) Metrics and Levels of Concern (LOC) for Aquatic Animals (fish and invertebrates)

RISK CLASS RISK DESCRIPTION RQ LOC

Acute Potential for effects to non-listed animals from acute
exposures Peak EEC/LC 50 1 0.5

Acute Restricted Use Potential for effects to an imals from acute exposures Risks may be mitigated through restricted use classification Peak EEC/LC 50 1 0.1

Acute Listed Species Listed species may be potentially affected by acute
exposures Peak EEC/LC 50 1 0.05

1 LC 50 or EC 50
.

2. RISK CHARACTERIZATION

Risk Estimation

Four representative end-use products were se lected for estimating exposures. Bug Barrier II, (EPA Reg. No.7754-41, 2.5% a.i.) was selectedto represent the highest quantity of Morpel ® in a single sale container formulated for use on humans. B Free of Flies (EPA Reg. No. 40322-2, 1.17% a.i.) was selected to assess the exposure vi a applications to horses because it had an application ra te on a per animal basis. DEET PLUS® COMPOSITE SPRAY II INSECT REPELLEN T (EPA Reg. No. 54287-13, 2.5% a.i.) was selected to estimate the exposures from horse applications because it had the highest percent a.i. Finally, PYRE-SECT dip (EPA Reg. No. 2382-89, 4% a.i.) was selected to assess the pet dip applications because it had the highest percen t a.i. for the pet dip uses.

Personal Application , Reg. Number: 7754-41: This product represents the highest rate of application to humans. It is formulated as a ready to use pressurized liquid (2.5% a.i.) that is sold in 12 oz. cans. The other rea dy-to-use product (also 2.5% a.i.) specified for human use does not state the container size; th erefore, a 12 oz. can was assumed for this product as well.

In this preliminary assessment, we consider th ree scenarios. In the first two scenarios, 10 and 100 people have applied aerosol spray to themselves and then go swimming in the farm pond, whereby 100% of the applied a.i. is washed off into the farm pond. In the third scenario, 50 cans of product are dumped into the farm pond. These scenarios are consistent with those used to assess ecologi cal risk from personal applications of DEET products in the DEET Preliminary Risk Assessment (DP399065).

Table 5 includes the estimate of a.i. app lied to one human in one day, while Table 6 includes the estimated exposure c oncentrations in the farm po nd for the three scenarios.Page 12 of 21 Amongst the scenarios, the highest exposure co ncentration in the farm pond is estimated to be 0.0196 mg a.i./L and is based on the scenario where 50 cans of product are dumped into the farm pond.

Horse Application: For product “ B Free of Flies” (EPA Reg. No. 40322-2) , the directions state to apply up to 2 ounces per head per day using either a soft cl oth or a fine mist spray. This equates to 597 mg a.i./individual animal per day 3 . For the DEET PLUS® COMPOSITE SPRAY II INSECT REPELLENT (2.5 % a.i.-Reg# 54287-13), the exposure estimate for an individual horse is 537 mg a.i./individual animal per day ( Table 5 ).

In this preliminary assessment for horse applic ations, we consider a conservative scenario where 10 horses are sprayed or wiped with Morpel ® formulated products and subsequently swim in the farm pond. These scenarios are comparable to those used to assess ecological risk from horse applications of DEET products in the DEET Preliminary Risk Assessment (DP399065).

Table 5 includes the estimate of a.i. app lied to one horse in one day, while Table 6 includes the estimated exposur e concentrations resulting from 10 horses swimming in the farm pond after product application. For bot h of the products a ssessed, the exposure concentration in the farm pond is estimated to be 0.0003 mg a.i./L.

Table 5. Amount of MORPEL Applied to One Human or Horse in One DayRepellentAmount of a.i. inproduct(mg a.i./mg product)Formulation-SpecificApplication Ratea(mg product/cm2skin)Fraction of BodyExposedaSurface Area toBody WeightRatioa(cm2/kg)Exposure Timea(hr./day)ApplicationFrequencya(# applications/hr.)Exposure(mg a.i./kg-day)bIndividualExposure(mg a.i./individual/day)c

Human (aerosol
spray, Reg# 7754-41) 0.025 1.10 0.75 280 3.7 0.25 5.34 427

Horse (pump
spray Reg# 54287-13 ) 0.025 0.62 0.75 100 3.7 0.25 1.08 537

a For adult human applications, these va lues were determined using default values from HED's SOPs as of July 11, 2011. For horses, the surface area per body weight and body weight values are 100 cm 2 /kg and 500 kg, respectively, based on an online resource cited in the 2011 DEET Preliminary Risk Assessment.

b Exposure calculated by multiplying th e values in the preceding six columns (see Standard Operating Procedures for Residential Pesticid e Exposure Assessment at http://www.epa.gov/pesticides/s cience/residential-exposuresop.html for details).

c Individual exposure calculated by multiplying estimat ed body weight (80 kg for adult humans and 500 kg for horses) by exposure (mg a.i./kg-day) from the preceding column.

3 2 fl. oz. product /horse x 1 gal/128 fl. oz. x 7.2 lbs product/gal x 453590 mg/lb *1.17% a.i.=597mg a.i./horsePage 13 of 21 Table 6. Estimated Concentration of MORPEL in the Standard Farm Pond

End-use product Scenario Total mg a.i. applied Concentration in farm pond (mg a.i./L)

Human (aerosol spray, Reg#

7754-41) 10 adults 4,274 0.0002

100 adults 42,735 0.0021

50 cans product 393,875 a 0.0196

Horse ( pump spray Reg# 54287- 13 ) 10 horses 5,377 0.0003

Horse (wipe/spray, Reg# 40322-2) 10 horses 5970 0.0003

a 50 cans x12 oz. product/can x 29.5735ml/oz. x 0.8879 g product/ml x 1000 mg/g x 2.5% a.i.

Pet Dip Application , Reg. Number: 2382-89: This is a pet (dog and cat) dip product sold as a 1 gallon concentrate solution and has the hi ghest percent a.i. of all pet dip products. The directions state that a maximum of 1 fluid ounce of product should be added to 1 gallon of water prior to use. Additionally, the label establishes a minimum re-application interval of 7 days.

In this preliminary assessment, we consider a conservative “down- the-drain” scenario where aquatic exposure concentrations are es timated using E-FAST v.2.0. Conceptually, the E-FAST model assumes that in a given year the entire pro duction volume of a chemical ( i.e. , a pesticide) is parceled out on a da ily basis to the en tire U.S. population and converted to a mass releas e per capita and daily per capi ta release to a wastewater treatment facility ( i.e. , g/person/day). This mass is then diluted into the average daily volume of wastewater released per person to arrive at an es timated concentration of the chemical in wastewater prior to enteri ng a treatment facilit y. The chemical’s concentration in untreated wastewater is then reduced by the fraction removed during wastewater treatment processes before releas e into a river or stream where it undergoes dilution. The inputs used in this model are described in Table 7 , as well as the resulting 10 th percentile surface water exposure estima te, 0.0186 μg/L, which is four orders of magnitude lower than the most sensitive toxi cological endpoint for aquatic organisms. The complete inputs and outputs from th e E-FAST v.2.0 model is included in Appendix B

. In addition to the E-FAST modeling, we consid er an extremely conservative scenario in which 2 gallons of pet dip concentrate ar e dumped into the standard farm pond. This results in a concentration of 0.015 mg a.i./L in the farm pond. With re gard to the applied pet dip solution ( i.e. , 1 fluid ounce of concentrate d iluted into 1 gallon of water),Page 14 of 21 dumping 1,251 gallons of pet dip solution into the farm pond results in a concentration of 0.020 mg a.i./L. See Table 8 for estimated exposure concentrations calculated for pet dips using this screen.

Table 7. Pet Dip “Down-the-Drain” Exposure Estimates using E-FAST v.2.0

E-FAST v.2.0 Inputs Value Source 10 th Percentile Surface Water Exposure Estimate

Total Expected Wastewater Treatment Removal 14.72% EPISUITE v.4.1

0.0186 μg/L Production Volume 898 kg a.i. /year Registrant Data

Bio-Concentration Factor 105.3 L/kg wetweight EPISUITE v.4.1 Regression-Based Method of Calculation

Table 8. Pet Dip Screen: Exposure Estimates via Farm Pond Dilution

Scenario Liters of Concentrate or Solution

Applied Total mg a.i. applied Total liters in farm pond Concentration in farm pond

(mg a.i./L)

328 gallons solution 1,251 390,320 20,001,251 0.020

2 gallons
concentrate 8 304,640 20,000,008 0.015

Surface Water Concentrations of Morpel ® Based on Monitoring

Surface water and sediment monitoring data from NAWQA and Califor nia Department of Pesticide Regulation are not available for Morpel ®

. Potential Risk to Terrestrial Organisms

Exposure to non-target terrestrial organisms and plants is pres umed negligible due to the limited exposure potential (ter restrial plants and animals) and relatively low toxicity (terrestrial vertebrates), thus, the potential for risk is not estimated.

Potential Risk to Aquatic Organisms

The expected concentrations of Morpel ® in the aquatic environment are orders of magnitude lower than the available aquatic LC 50 and EC 50 s determined for Morpel ® ( Table 9 ), and, thus, the potential for risk to aquatic species is low.Page 15 of 21 Table 9. Aquatic exposure estimates and RQs for Morpel ®

End-use product % a.i. Total application EEC (mg a.i./L in pond) Acute Fish RQ(EndpointLC 50 =0.44 mg a.i./L) Acute Invertebrate RQ (Endpoint-EC 50 = 18 mg.a.i./L)

Bug Barrier II (EPA Reg. No.7754-41);

Aerosol Spray 2.5 10 adults 0.0002 0.0005 1.19 x 10 -5

100 adults 0.0021 0.0049 0.0001

50 cans 0.0196 0.0445 0.0011

B Free of Flies (EPA Reg. No. 40322-2); wipe-on/spray 1.17 10 treated horses 0.0003 0.0007 1.6 x10 -5

DEET PLUS® COMPOSITE SPRAY II INSECT REPELLENT (EPA Reg. No. 54287-13) 2.5 10 treated horses 0.0003 0.0007 1.6 x10 -5

PYRE-SECT dip (EPA Reg. No 2382- 89); dog and cat dip 4.0 898 kg a.i./yr 1.86 x 10 -5 (concentration released to a water body) 4.23 x 10 -5 1.03 x 10 -6

328 gallons

solution 0.020 0.04 0.001

2 gallons
concentrate 0.015 0.03 8 x 10 -4

No LOC exceedances Acute risk to non-listed species LOC for aquatic organisms is 0.5 Acute risk to listed species LOC for aquatic organisms is 0.05

Incident Database Review

A review of the following databases was completed in April (2014):

 Ecological Incident Information System (EIIS)

 OPP Aggregate Incident Reports database

 Avian Monitoring Information System (AIMS) http://www.abcbirds.org/abcprog rams/policy/toxins/aims/aims )

There were no reported incidents for Morpel ®

.Page 16 of 21 Risk Description

Aquatic Organisms

The results of risk estimation indica te that registered uses of Morpel ® will not result in LOC exceedances for acute risk to fish and invertebrates. Chronic RQs were not calculated; however, given the ECOSAR-estimat ed toxicity values were similar (within an order of magnitude) for the acute and chronic endpoints and that RQs were only approaching an exceedance in the most cons ervative and highly unlikely scenarios, chronic risk to fish and i nvertebrates is not expected.

RQs were not calculated for aquatic plants as toxicity data were not available. EFED presumed direct risks were lower than c oncern levels to aquatic plants given the ECOSAR-estimated toxicity and lack of exceed ances for other aquatic organisms. Also, there are no reported incidents for aquatic organisms or plants.

Terrestrial Organisms

Exposure in terrestrial habitats is not expected as the products formulated as lotions or impregnated wipes would be applied directly to the skin/animal and spray products would likely be applied at distances of less than 10 inches from the intended application sites (human skin/horse skin and hair). Thus, expos ure to terrestrial organisms is not expected because they would not likely come in close contact with humans or domestic animals ( i.e., the registered use sites). Even if a non-ta rget organism were to come into contact with Morpel ® from over-spray or through contamin ated food items the exposure levels would be expected to be low; therefore, given its low toxi city profile (for terrestrial animals), effects to non-target organisms w ould not be anticipated to exceed concern levels even if exposure occurred.

Data are not available to assess the risk to terrestrial invertebrate s; however, given that Morpel ® is an insect repellent (that is also co-formulated with other repellents), the potential exposure is lik ely only due to chance ( e.g., flying through the 10 inch spray directed at the human/horse or landing on th e human/horse). Additionally, the repelling action of the formulated active ingredient s will also reduce th e likelihood of such occurances. Exposure to terrestr ial plants is not expected, thus , there is no risk expected for plants.

Uncertainties and Data Gaps

Although only a hydrolysis study was required by and submitted to the EPA, additional fate data would not change the risk conc lusions in this assessment. The exposure modeling conducted assumed that Morpel ® is stable to all de gradation and dissipation
processes.Page 17 of 21 Few ecotoxicity studies have been submitted to the EPA. However, under the currently registered use patterns, EFED has conclude d (1) low likelihood of risk to aquatic organisms and (2) highly unlikely exposure to terrestrial organi sms. Unless the use patterns of Morpel ® change through proposed regist rations of new products, EFED considers the current ecotoxicity database to be sufficient.

3. ENDANGERED SPECIES ASSESSMENT

The results of this assessment on currently registered Morpel ® uses indicate that there are no level of concern (LOC) exceedances to listed or non-listed fish or aquatic invertebrates, and no reasonable expectation of effects to birds, reptiles, amphibians, mammals and plants. The EPA makes a No E ffects (NE) determination for all Federallylisted species and a No Habitat Modification determination for all designated critical habitats for the currently registered uses of Morpel ®

.Page 18 of 21 Appendix A: E-FAST v.2.0 Model Output

INITIAL REVIEW EXPOSURE REPORT

CHEMICAL ID: tmpcas

ENVIRONMENTAL RELEASES OF CHEM ICALS IN HOUSEHOLD PRODUCTS

SCENARIO #: 1 EXPOSE D POPULATION:Adult

WWT REMOVAL (%) PRODUCTION VOLUME

(kg/yr) HOUSEHOLD RELEASE

DAYS PRETREATMENT RELEASE (g/person/day) POSTTREATMENT

RELEASE (g/person/day) BODY WEIGHT (kg) BCF (L/kg)

14.72 898.00 365.00 8.46E-06 7.21E-06 71.80 105.30

10 th PERCENTILE DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Fish Ingestion

Results ASSUMPTIONS

ED (years) AT (years) DW IR (L/day) FISH IR (g/day)

Cancer

LADD pot 3.47E-08 mg/kg/day 1.56E-08 mg/kg/day 57.00 75.00 1.40 6.00

LADC pot 1.78E-06 mg/L 1.87E-04 mg/kg 57.00 75.00 NA NA

Acute

ADR pot

8.63E-07 mg/kg/day 1.95E-06 mg/kg/day NA 1 day 6.00 129.00Page 19 of 21 50 th PERCENTILE DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Fish Ingestion

Results ASSUMPTIONS

ED (years) AT (years) DW IR (L/day) FISH IR (g/day)

Cancer

LADD pot 2.04E-09 mg/kg/day 9.22E-10 mg/kg/day 57.00 75.00 1.40 6.00

LADC pot 1.05E-07 mg/L 1.10E-05 mg/kg 57.00 75.00 NA NA

Acute

ADR pot

3.92E-08 mg/kg/day 8.87E-08 mg/kg/day NA 1 day 6.00 129.00

50 th PERCENTILE AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10

STREAM DILUTION FACTOR 134.85 39.66 24.22 20.08

CONCENTRATION ( μ g/L) 1.38E-04 4.69E-04 7.68E-04 9.26E-04

10 th PERCENTILE AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10

STREAM DILUTION FACTOR 7.95 1.80 1.00 1.00

CONCENTRATION ( μ g/L) 2.34E-03 1.03E-02 1.86E-02 1.86E-02Page 20 of 21 Appendix B: ECOSAR Model Output

ECOSAR Version 1.11 Results Page

SMILES : c1(C(=O)(OCCC))ccc(C(=O)(OCCC))nc1 CHEM : CAS Num: ChemID1: MOL FOR: C13 H17 N1 O4 MOL WT : 251.28 Log Kow: 2.124 (EPISuite Kowwin v1.68 Estimate) Log Kow: (User Entered) Log Kow: 3.57 (PhysProp DB exp value - for comparison only) Melt Pt: (User Entered for Wat Sol estimate) Melt Pt: (deg C, PhysProp DB exp value for Wat Sol estimate) Wat Sol: 20.8 (mg/L, EPISuite WSKowwin v1.43 Estimate) Wat Sol: (User Entered) Wat Sol: (PhysProp DB exp value)

-------------------- ------------------ Values used to Generate ECOSAR Profile

--------------- ------------- ---------- Log Kow: 2.124 (EPISuite Kowwin v1.68 Estimate) Wat Sol: 20.8 (mg/L, EPISuite WSKowwin v1.43 Estimate)

-------------- ------------------ ---------------- Available Measured Data from ECOSAR Training Set No Data Available

ECOSAR v1.1 Class-specific Estimati ons--------------

--------------- --------- Esters Predicted ECOSAR Class Organism Duration End Pt mg/L (ppm)

========================= == ================== ======== ======

========== Esters : Fish 96-hr LC50 28.435 * Esters : Daphnid 48-hr LC50 58.329 * Esters : Green Algae 96-hr EC50 24.342 * Esters : Fish ChV 2.084 Esters : Daphnid ChV 38.485 * Esters : Green Algae ChV 6.49 Esters : Fish (SW) 96-hr LC50 42.929 * Esters : Mysid 96-hr LC50 39.721 * Esters : Fish (SW) ChV 6.293 Esters : Mysid (SW) ChV 2270.193 * Esters : Earthworm 14-day LC50 2988.053 *

========================= == ================== ======== ======

==========Page 21 of 21 Neutral Organic SAR : Fish 96-hr LC50 159.735 * (Baseline Toxicity) : Daphnid 48-hr LC50 91.743 * : Green Algae 96-hr EC50 71.653 * : Fish ChV 15.826 : Daphnid ChV 9.237 : Green Algae ChV 19.249

Note: * = asterisk designates: Chemical may not be soluble enough to measure this predicted e ffect. If the effect level exceeds the water solubility by 10X, typically no effects at saturation (NES) are reported.

------------------ ------------ Class Specific LogKow Cut-Offs

------------------ ------------ If the log Kow of the chemical is grea ter than the endpoint specific cut-offs presented below, then no effects at sa turation are expected for those endpoints.

Esters:

------ Maximum LogKow: 5.0 (Fish 96-hr LC50; Daphnid LC50, Mysid LC50) Maximum LogKow: 6.0 (Earthworm LC50) Maximum LogKow: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)

Baseline Toxicity SAR Limitations:

------------------ --------------- Maximum LogKow: 5.0 (Fish 96-hr LC50; Daphnid LC50) Maximum LogKow: 6.4 (Green Algae EC50) Maximum LogKow: 8.0 (ChV)