2 

## REGISTRATION REVIEW

PROBLEM FORMULATION

Noviflumuron

CAS Number 121451

- 02

- 3

US EPA PC CODE 118204

Prepared by: Ed Odenkirchen, Ph.D., Senior Science Advisor Christopher M. Koper, M.S., Chemist
Environmental Risk Branch 1

Reviewed by: Meghan Radtke, Ph.D., Acting RAPL Stephen Wente, Ph.D., Biologist
Environmental Risk Branch 1 U.S. Environmental Protection Agency Office of Pesticide Programs
Environmental Fate and Effects Division

Environmental Risk Branch I 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 204603



### 1 Executive Summary

The Environmental Fate and Effects Division (EFED) has completed the preliminary problem formulation for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the registration review of novif lumuron . The problem formulation describes the methods planned to be used during the completion of drinking water and ecological risk assessments in support of R egistration R eview and provides an overview of the environmental fate, ecological effects, and potential risks associated with the use of noviflumuron as well as uncertainties unique to risk assessment of noviflumuron

. This document also identifies additional studies that would be beneficial to the conduct of an ecological risk assessment.

Majo r findings include the following data needs described below:

 Acute oral toxicity in a passerine bird : The exposure concept for this risk assessment places insectivorous birds as a non

- target receptor via consumption of termites feeding on
bait. The most likely insectivorous birds to be exposed would be passerines.

 Avian reproduction studies for an upland game bird and a waterfowl species . These data are essential for evaluating the potential for noviflumuron to affect the fitness of avian species thr ough impacts to reproduction. The use of noviflumuron in bait boxes will likely involve long

- term placement of treated baits. This is likely to result in residues being incorporated into insect biomass (termites) over considerable periods of time. This Problem Formulation has established that termites, contaminated with noviflumuron constitute a complete exposure pathway to ground feeding insectivorous terrestrial
vertebrates

. Without these data, the risk assessment will consider reproduction data in oth er insect growth regulator compounds (e

. g. , d ata from hexaflumuron (D405911) with a similar use patter n returned chronic risk quotients threefold higher than the A gency established chronic risk level of concern )

, or more structurally and mechanistically distant compounds

.

A maj or uncertainty is that m any of the current labels for noviflumuron products do not specify the amount of product present in each bait station. In addition, labels do not specify the maximum
number of bait stations that can be present on a designated area of land. Therefore, as the labels are now, application rates of noviflumuron applied to a unit area (i.e., lbs a.i./A) cannot be
determined

. In addition, h oles can be drilled for gel use (via applicator syringe) to locations o f active galleries but there is no mention of how many holes can be drilled per unit area and mass per area cannot be determined. Assumptions and limitations are provided in Section 1 4

.



### 2 Introduction

Noviflumuron is a benzoylphenylurea insecticide/termit icide. Benzoylphenylurea molecules inhibit chitin synthesis, but the precise target enzyme for noviflumuron is not known for certain.

T he mechanism of toxicity is tied closely with a specific life stage of an insect

– physical m olting

– thus , its speed of action is relatively slow compared to other insecticides. However, it is this slow4

activity that provides a favorable response to control social insects that tend to exhibit avoidance behaviors when exposed to sick or dead members of the population, such a s termites.

Noviflumuron was originally registered for use in the United States in September 1990, as a conventional pesticide. It is used in conjunction with a monitoring system to control outbreaks of termites, subterranean termites, and cockroaches af ter a problem has been identified.



### 3 Use Characterization

Currently, noviflumuron is registered for use in above

- and below

- ground termite bait systems.
There are 7 active end

- use products con taining noviflumuron.

Noviflumuron is present at 0.5% (i.e. , 0.5 grams in 100 grams of bait product) in a bait matrix housed in a rigid plastic structural housing with small access windows opened by the user to allow for termite access. Bait stations are mounted to solid surfaces such as trees, decks, fences, bui lding surfaces, and crawl spaces in locations where termites are actively foraging. These bait stations are not designed to attract termites and do not contain an attractant . Many of the current labels for noviflumuron products do not specify the amount o f product present in each bait station. In addition, labels do not specify the maximum number of bait stations that can be present on a designated area of land. Therefore, as the labels are now, application rates of noviflumuron applied to a unit area (i.e ., lbs a.i./A) cannot be determined.

Noviflumuron is applied as a gel (via applicator syringe) to locations of active galleries or mud
tubes on buildings by injecting the material into cracks or by drilling small holes into areas of active galleries. The se holes are then sealed after application. 0.5 to 2 grams of gel bait (0.0025 to 0.01g ai) are applied per treatment site. Noviflumuron may be reapplied as needed to gain localized
control or to treat new active sites.



### 4 Conclusions from Previous Risk Asse ssments

4.1 Ecological Risk Assessments

The Agency conducted two previous ecological risk assessment s for noviflumuron:

 Section 3 request for use of noviflumuron in a gel bait formulation to control cockroaches
and foraging subterranean termites ( 2005; DP Barcode : D307981)

 Section 3 request for use of noviflumuron in a bait formulation to control termites ( 2003;
DP Barcode s: D285883, D288937)

The conclusions shared by these assessment s were:

 Environmental exposures are expected to be low when used as dir ected on the proposed
label.

 The greatest concern for potential risks is associated with environmental exposures to mammals feeding on exposed bait.

 Potential risks to birds and representative taxa is less than that of mammals ; h owever, these
risk s may be underestimated because the contribution to a bird ’ s diet from the ingestion of contaminated prey was not included in the risk estimation.5

4.2 Drinking Water Exposure Assessments

Noviflumuron is applied in above

- and below

- ground bait stations. Given this ap plication method, it has historically been viewed as a “closed system” with minimal likelihood of environmental exposure. Therefore, there is no previous drinking water exposure assessment for this chemical.

Drinking water exposures are likely to be low and would not likely exceed the known water solubility of 194 μg/L. In addition, based on the high affinity of this compound to sorb to sediments and organic materials, removal in physical drinking water treatment processes (flocculation/coagulation follow ed by sedimentation and/or filtration) is likely, but not quantifiable. Groundwater concentrations are expected to be low, including in areas of high sand content based on high sorption coefficients.

4.3 Clean Water Act Programs

Noviflumuron is not identifi ed as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. No Total Maximum Daily Load (TMDL) criteria have been developed for noviflumuron . Any data submitted or ot herwise located as part of the Regi stration R eview process may be used to update aquatic life benchmarks

, if applicable.



### 5 Environmental Fate and Transport

In soil, t he primary route of dissipation for noviflumuron is aerobic metabolism. Noviflumuron is stable to hydrolysis at neutral to acidic pHs, but degrades with a half

- life of 19 days in alkaline pHs. Given the methods of application (e.g., above

- and below

- ground bait stations), the material will not be subject to photodegradation when used as proposed. Since there was a poor correlation between Kd and percent organic carbon, Kd values were utilized to describe mobility of
noviflumuron. K d values ranging from 859

- 7,828 in four U.S. soils and 1,475

- 3,425 in four U .K.
soils indicate that nov iflumuron is immobile . Noviflumuron's low solubility in water, high
octanol

- water partition c oefficient, and im mobility in soil indicate that it will not dissolve in any moisture that may enter the bait stations . In the event t hat some noviflumuron was leache d from
the bait stations , it should bind readily to the soil. Additionally, cur rent labels carry the
environmental hazard statement “ This product is highly toxic to aquatic invertebrates and possibly to fish. Do not allow t he bait or its noviflumuron contents to be washed into a body of water containing aquatic life, such as a pond or stream ” which should reduce, if not eliminate, the chances for noviflumuron to migrate to surface and ground water. Considering noviflumuron’ s properties and registered uses

, aquatic exposure is not expected

.

Although the mobility of noviflumuron’s degradates has not been adequately determined, it appears that degradates, which are produced under environmental conditions , are not highly
mobi le. Due to the lack of anaerobic fate data, noviflumuron’s persistence in anaerobic environments has not adequately been determined. In addition, noviflumuron’s low vapor pressure and application methods suggest that volatilization of the active ingredie nt should not occur.6

A selection of environmental fate and transp ort properties of noviflumuron is summarized in Table
5

- 1

.

Table 5

- 1

. Chemical Properties and Environmental Fate Parameters of Noviflumuron

Parameter Value Source/MRID #

Common name Noviflumuron

Product Chemistry CAS number 121451

- 02

- 3

Chemical name (RS)

- 1

- [3,5

- Dichloro

- 2

- fluoro

- 4

- (1,1,2,3,3,3 hexafluoropropoxy)phenyl]

- 3

- (2,6

- difluorobenzoyl)urea Chemical Class/Category Benoylphenylurea Insecticide Empirical formula C 1 7 H 7 Cl 2 F 9 N 2 O 3

Structure

Molecular Mass 529.15 g/mole Water Solubility 0.194 mg/L at 25  C Vapor pressure (25  C) 5.39 x 10

- 12 mm Hg Henry’s Law Constant 1.9 x 10

- 11 atm m 3 /mol Calculated 1
Octanol/water partition coefficient (K
ow ) 87,096 (log Kow = 4.94 ) Product Chemistry

Dissociation Constant (pKa)

-- M olecule does not contain reversibly
ionizable functional

groups

Hydrolysis (t 1/2 at 25  C) pH 5 = stable pH 7 = stable pH 9 = 19 da ys 45232421 (A)

Aerobic Soil Metabolism (t 1/2 ) 231 days (silt loam

– benzoyl label )
251 days (loam

– benzoyl label )

263 days ( silty clay loam

– benzoyl label )
344 days (silt loam

– aniline label )

202 days loam

– aniline label )
399 days (silty clay loam

– aniline label ) 45516708 (A)

Soil Partition Coefficient (K d ) (mL/g) Kd values 1,614

– 1,994 (IN loam)
859

– 1,437 (IN sand) 4,013

– 7,828 (ND loam) 3,008

– 3,755 (ND clay) 1,475

– 3,115 (UK silt loam) 3,151

– 2,897 (UK silty clay loam) 2,137

– 3,275 (UK sand) 2,545

– 3,425 (UK sandy clay loam) 45516709 (A)

1 = Henry’s Law (atm

- m 3 /mole) = (VAPR/760)/(SOL/MWT), where VAPR is vapor pressure in torr, MWT is molecular weight in g/mol, and SOL is the solubility in water in mg/L. A = Acceptable data7

5.1 Transformation Products

Two major o rganic degradates of noviflumuron (XDE

- 007) formed under relevant environmental
conditions : the urea and amine related forms of noviflumuron, described as XDE

- 007 urea (45.8% formed during hydrolysis; MRID 45232421) and XDE

- 007 amine (11.8% formed during hydrolysis; MRID 45232421 and 13.9% formed during aerobic soil metabolism; MRID 45515708)

. Two other major degradates, XDE

- 007 amide (28%) and XDE

- 007 DFBA (59%)

, formed during a noviflumuron hydrolysis study conducted at 50oC. Although this temperature is

out side of typical environmental conditions, t heir formation was significant and they are common degradates of a similar chemical

, hexaflumu ron (PC 118202)

, so they were a dded as additional information. Significant mineralization occurred during an aerobic soil metabolism study (45.7%

CO 2 evolution; MRID 45515708). In addition, maximum unextracted residues were detected at 26.9% by study ter mination (365 days) during an aerobic soil metabolism study (MRID 45515708). Table 5

- 2 summarizes the transf ormation products of noviflumuron and their
maximum amounts formed.

No environmental fate studies conducted with noviflumuron degradates have been submitted. Therefore, the behavior of these degradates is not well understood. V apor pressures , Henry’s

Law constants

, octanol

- water partition coefficients, water solubility , and Koc values were
estimated using EPISuite (see Table 5.3 ) for comparison to the parent noviflumuron. Degradates

XDE

- 007 amide and XDE

- 007 DFBA l appear to be more water soluble and mobile than the
parent compound whereas XDE

- 007 urea and XDE

- 007 amine show similar properties (low water solubility, high Kow and Koc values) to the parent. In addition, the degradate structures show that they retain the majority of the parent structure.8

Table 5

- 2 .Noviflumuron and Its Major Environmental Degradates

Code Name/ Synonym Chemical Name Chemical Structure Study Type MRID Maximum Formation (% Applied)

Noviflumuron (XDE

- 007) CAS Name:

(RS)

- 1

- [3,5

- Dichloro

- 2

- fluoro

- 4

- (1,1,2,3,3,3 hexafluoropropoxy)phenyl]

- 3

- (2,6

- difluorobenzoyl)urea

Molecular Weight: 529.15 g/mol

Chemical Formula:
C 17 H 7 Cl 2 F 9 N 2 O 3

SMILES: Clc1c(c(c([H])c(c1OC([C@]([H])(C (F)(F)F)F)(F)F)Cl)N([H])C(N([H])C (c2c(c([H])c([H])c([H])c2F)F)=O)= O)F Parent structure shown for reference

XDE

- 007

Urea Molecular Weight: 389.06 g/mol

Chemical Formula:
C 10 H 5 Cl 2 F 7 N 2 O 2

SMILES: Clc1c(c(c([H])c(c1OC([C@]([H])(C (F)(F)F)F)(F)F)Cl)N([H])C(N)=O)F Hydrolysis pH 9 at 25oC, 33 days 45232421 45.8 (33 days)

Hydrolysis pH 9 at 50 oC, 1 day 45232421 30 .8 ( 1 day ; 50oC )

XDE

- 007
Amine Molecular Weight: 346.03 g/mol

Chemical Formula:
C 9 H 4 Cl 2 F 7 NO

SMILES: Clc1c(c(c([H])c(c1OC([C@]([H])(C (F)(F)F)F)(F)F)Cl)N)F Hydrolysis pH 9 at 25oC, 33 days 45232421 11.8 (28 days)

Aerobic Soil Metabolism 45515708 13.9 (365 days)9

Code Name/ Synonym Chemical Name Chemical Structure Study Type MRID Maximum Formation (% Applied)

XDE

- 007
Amide Molecular Weight: 157 g/mol

Chemical Formula: C 7 H 5 F 2 NO

SMILES: NC(=O)c1c(F)cccc1F Hydrolysis pH 9 at 50oC , 1 day 45232421 28.0 (1 day ; 50oC )

XDE

- 007 2,6

- difluorobenzoic acid (DFBA) Molecular Weight: 158.11 g/mol

Chemical Formula:
C 7 H 4 F 2 O 2

SMILES: OC(=O)c1c(F)cccc1F Hydrolysis pH 9 at 50oC , 1 day 45232421 59

. 3 (1 day ; 50oC )

CO 2 Carbon Dioxide O=C=O Aerobic Soil Metabolism 45515708 45.7 (365 days)

Unextractable
Residues Aerobic Soil Metabolism 45515708 26.9 (365 days)

Note: The amide and DFBA degradates formed only in a hydrolysis study conducted at 50oC for 1 day. Their formation was significant and they are common degradates of hexaflumuron (PC 118202) so they were added for additional information. The values were italicized for clarity.10

Table 5

- 3. Fate Parameters f or Noviflumuron Degradates, Estimated Using EPISuite v. 4. 10

Chemical/Fate parameter Noviflumuron

(XDE

- 007) XDE

- 007

Urea XDE

- 007

Amine XDE

- 007

Amide 2,6

- Difluorobenzoic acid

(DFBA)

Molecular Weight (g/mol) 529 389 346 157 158

Vapor Pressure (torr) 5.39 x 10

- 12 6.71 x 10

- 6 2.36 x 10

- 3 2.86 x 10

- 4 1.76 x 10

- 3

Octanol

- water Partition Coefficient (Log K OW ) 4.94 4.57 4.94 0.25 1.59

Water Solubility (mg/L; at 25 °C) 0.194 .450 .398 43,140 3,063

Henry's Law Constant (atm

- m 3 mol

- 1 ) 1.9 x 10

- 11 7.63 x 10

- 6 2.70 x 10

- 3 1.37 x 10

- 9 1.20 x 10

- 7

Leaching/Mobility

K oc (L/kg) 30,670

- 43,560* 2999

- 5597* 4919

- 10,600* 7

– 46* 11

– 44*

*Range of 2 values, EpiSuite estimates11



### 6 Receptors

The content s in above ground portions of noviflumuron bait boxes are considered to be inaccessible to wildlife save for one exposure pathway. The exposure pathway considered to be complete for terrestrial invertebrate and vertebrate predators of termites feed ing on noviflumuron materials within enclosed bait boxes, thus, this problem formulation only presents effects
information relative to t he se taxonomic groups. While data submissions for fish, aquatic invertebrates, and aquatic and terrestrial plants have been made for noviflumuron , these taxonomic groups are not expected to be exposed to the chemical and so will not receive quantitative
assessment of risk. Table 6

- 1 provide s a summary of toxicity endpoints used to characterize the potential acute and chronic ecological effects of noviflum u ron to taxonomic groups to be

cons idered in the risk assessment.12

Table 6

- 1 . Summary of the Endpoints from Terrestrial Toxicity Studies for Noviflumuron

Taxon Study Type

TGAI/TEP (% a.i.) Species Toxicity Value, Effects, & Acute Toxicity Classification (If Applicable) Source & Study
Classification

Birds (surrogate for reptiles and
terrestrial

phase amphibians) Acute oral: single dose,

14

- day observation

TGAI ( 98.6 ) Bobwhite quail (Colinus virginianus) LD 50 > 2 000 mg a.i./kg

- bw (nom)

NOAEL: 2000 mg a.i./kg

- bw (nom) ( n o signs of toxicity )

Practically non

- toxic MRID 45232406 Acceptable

Acute oral Passerine species No data NA

Sub

- acute dietary: 5

- day exposure; 3

- day post

exposure observation

TGAI (91.5) Bobwhite quail (Colinus virginianus) LC 50 4100 mg a.i./kg

- diet (nom) 95% C.I.: 3200

- 5000 mg a.i./kg

- diet NOAEC = 320 mg a.i./kg

- diet (nom) LOAEC = 580 mg a.i./kg

- diet (nom) (NOAEC based on reduction in body weight gain)

Practically non

- toxic MRID 45516722 Acceptable

Sub

- acute dietary: 5

- day exposure; 3

- day post

exposure observation

TGAI ( 98.4 ) Mallard duck (Anas platyrhynchos ) LC 50 > 5300 mg a.i./kg

- diet (nom)

NOAEC = <320 mg a.i./kg

- diet (nom)

LOAEC = 320 mg a.i./kg

- diet (nom) (no mortality; NOAEC based o n reduction in body weight gain)

Practically non

- toxic MRID 45516721 Acceptable

Reproduction (chronic) Bobwhite quail (Colinus virginianus) No data NA

Reproduction (chronic) Mallard duck (Anas platyrhynchos ) No data NA

Mammals Acute oral TGAI 95.6% Rat LD 50 >5000 mg a.i./kg

- bw (nom) NOEC 5000 mg a.i./kg

- bw (nom) MRID 45232409 Acceptable

1

- Gen Reproduction
TGAI 95.6% Rat NOAEC>1000 mg a.i.,/kg

- bw 9nom) MRID 45232419 Acceptable

Terrestrial
invertebrates Acute contact: single

dose, 48

- hour observation Honey bee ( Apis mellifera ) No data NA13

Taxon Study Type

TGAI/TEP (% a.i.) Species Toxicity Value, Effects, & Acute Toxicity Classification (If Applicable) Source & Study
Classification

Acute dietary (oral) Honey bee ( Apis mellifera ) No data NA

Larval honey bee ( Apis mellifera ) No data NA

NA = not applicable ; nom = nominal14

6.1 Ecological Incidents

A preliminary review on June 12, 2014 , of the Ecological Incident Information System (EIIS, version 2.1), the IDS aggregated incident database, which are maintained by the Agency’s Office of Pesticide Programs, and th e Avian Monitoring Information System (AIMS), which is maintained by the American Bird Conservancy, indicates no reported ecological incidents
associated with the use of noviflumuron

.



### 7 Exposure Pathways of Concern

Considering the fate parameters for novi flumuron and the method of application ( i.e., bait stations), the only perceived means of noviflumuron moving into the environment ( e.g., soil and surface water) would be via termites eating the bait and then transporting it away from the bait
station. Onc e in the termite, novi flumuron could be transferred to termite predators.

Termite colonies provide a concentrated and protein

- rich food source and are a viable prey item (Wood and Sands, 1978). These attributes are consistent with foraging theory (Carrol l and Janzen, 1973; Oster and Wilson, 1978) that utilization of termites as a food source would minimize foraging costs

, optimize yield

, and result in a net gain in predator energy. Termite colonies are relatively sessile (confined within the bounds of t he nest substrate) and stable through time. A stable food source can be efficiently exploited by reducing travel distances and travel time (Hçlldobler and Lumsden, 1980; McIver, 1991; Davidson, 1997). Termite colonies are also highly clumped, thus allowin g efficient prey discovery and retrieval (Traniello, 1983; Pasteels et al., 1987).

There are likely three scenarios for termite predatory behavior. The first is consumption of termites while concentrated in the nest area itself, which may be reserved f or only a few larger vertebrate species that are able to excavate such areas. The second is consumption of foraging worker termites incidentally while ground foraging, which may be an exposure route for a variety of ground foraging birds, reptiles, amphibi ans, and small mammals. The third s cenario is predat ion on the alates (mating cast of termites that are capable of flight) by a variety of terrestrial vertebrate predators feeding on ground and aerial swarms of alates. However, for noviflumuron, with its mode of action focusing on disruption of metamorphosis, it is unlikely that alates will be present

.

Based on the K ow and K oa of this chemical, it has the potential to bioaccumulate in termite predators. Therefore, future ecological risk assessments of no vi flumuron will involve assessing exposures of terrestrial animals to novi flumuron through consumption of contaminated termites. This can be accomplished by estimating the mass of novi flumuron per termite and deriving dietary

based and dose

- based exposure concentrations for terrestrial animals through consumption of
contaminated termites.

Empirical data may also be used to represent the mass of noviflum u ron per termite. For example, an available study for the chemical he xaflum u ron measuring the uptake rat e of 0.5% 14 C labeled hexaflumuron in termites reported a steady state concentration of 320 ng (radioactive15

material)/termite (MRID 45516725). In this study, steady state was reached after 9

- 12 days. A representative termite body weight, such as 3 mg (Zhou et al . 2008), can be used to translate the measured pesticide mass per termite to a concentration basis of 107 mg hexaflumuron/kg termite.
This value can then be used to derive dose

- based EECs for terrestrial animals potentially consuming termites using allometric equations intended to estimate food intake rates for mammals and birds (USEPA 1993).



### 8 Analysis Plan

8.1 Stressors of Concern

8.1.1 Ecological Risk Assessment

The risk assessment will address noviflu m uron parent. While degradates are apparent in environmental fate testing, the conditions they represent (pesticide in water, pesticide mixed in soil, pesticide exposed to direct sunlight) are not expected to be encountered for a pesticide placed
in bait boxes

. Consequently degradates are not expected to be present at points of non

- target organism exposure.

8.1.2 Drinking Water Exposure Assessment

Based on the application methods ( e.g., above

- and below

- ground bait and gel stations) and the fate properties ( e.g ., log K ow = 4.94, K d range 859 to 7,828 mL/g) of noviflumuron, the potential for noviflumuron to migrate to the soil and to further migrate to surface water and/or ground water
sources is considered minimal.

8.2 Measures of Exposure

EFED will not use standard available models t o evaluate potential exposures to aquatic and terrestrial organisms as described at http://www.epa.gov/pesticides/science/models_db.htm . As described earlier, bait box placements preclude a concern for aquatic organism exposure and the exposure pathway of potential concern is one in which exposed termites constitute a vector
between bait box

- placed pesticide and vertebrate and invertebrate predators of termites. The risk
assessment will es timate exposure by allocating bait box pesticide content to termit es and
then treat termite residues as a diet

- available residue to pre dators of the termi tes.

8.2.1 Available Monitoring Data

The Agency is aware of monitoring conducted by federal and state agen cies

, and this route of exposure will be considered in the assessment to the extent that data on noviflumuron are available.

8.3 Measures of Effect

Toxicity data presented in Section 6 of this problem formulation will be used to calculate risk quotients. Any additional information submitted by the registrant or found in the open literature16

prior to conduct ing the risk assessment will also be considered. The open literature studies are identified using EPA’s ECOTOXicology database ( ECOTOX) 1 , which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The evaluation of both sources of data can also provide insight into the direct and indirect effects of pesticides on biotic communities from loss of species that are sensitive to the chemicals and from changes in structure and functional characteristics of the affected communities.



### 9 Endangered Species Assessments

Consist ent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally

- listed threatened and/or endangered (listed) species from registered
uses of pesticides in registration review . The process for evaluat ing potential risks to listed species
is further described at http://www.epa.gov/oppfead1/endanger/litstatus/riskasses.htm

.



### 10 Endocrine Disruptors Screening Program

Noviflumuron was not included in the chemicals issued an order to conduct Tier 1 EDSP testing. For additional information the EDSP program, visit http://www.epa.gov/endo/

.



### 11 Preliminary Identification of Data Gaps

11.1 Environment al Fate

Table 11

- 1 identifies environmental fate studies by MRID that offer data for each guideline requirement

, study classifications

, and whether or not further data are needed to support the risk

assessment.

Table 11

- 1. Submitted Environmental Fate Data for Noviflumuron

Guideline Description MRID Classification Data Gap? Comments

835.2120 Hydrolysis 45232421 Acceptable No

--

835.2240 Aqueous Photolysis NA Not a pplicable No A

835.4100 Aerobic soil metabolism 45516708 Acceptable No

--

835.4200 Anaerobic soil metabolism NA Not a pplicable No B

835.4300 Aerobic Aquatic Metabolism NA Not applicable No A

835.4400 Anaerobic Aquatic Metabolism NA Not applicable No A

835.1230
835.1240 Leaching and adsorption/

desorption 45516709 Acceptable No

--

835.6100 Terrestrial Field Dissipation NA Not applicable No C

850.1730 Bioaccumulation in Fish NA Not applicable No D

1 http://cfpub.epa.gov/17

Guideline Description MRID Classification Data Gap? Comments

A = When used as proposed, the material is contained inside a bait or gel station and should not be exposed to aqueous
environments. B = Although anaerobic soil metabolism data would help characterize degradation in anaerobic soil environments (as this chem ical can be used in un derground bait stations), the data are not used as a modeling input parameter
and value added is limited. C = No Field Applications (bait stations only)

. D = Although the log K ow of noviflumuron (4.94) is greater than 3, this is not considered a data gap, as the potential exposure to fish is negligible.

11.2 Ecological Effects

Table 11

- 2 identif

ies ecological effects studies by MRID that offer data for each guideline requirement, study classifications

, and whether or not further data are needed to support the risk

assessment for noviflumuron as labeled for use

. It should be noted that this list only includes data gaps relative to the conduct of a risk assessment that quantitatively addresses risks only for the complete exposure pathways that involve terrestrial organisms.

Data gaps of note include:

 Acute oral toxicity in a passerine bird : The exposure concept for this risk assessment places insectivorous birds as a non

- target receptor via consumption of termites feeding on bait. The most likely insectivorous birds to be exposed would be passerines.

 Avian reproduction studies for an upland game bird and a waterfowl species . These data are essential for evaluating the potential for noviflumu ron to affect the fitness of avian species through impacts to reproduction. The use of noviflumuron in bait boxes will likely involve long

- term placement of treated baits. This is likely to result in residues being in corporated into insect biomass ( termites) ov er considerable periods of time. Without these data, the risk assessment will consider reproduction data in other insect growth regulator compounds . Avian reproduction data are available for
hexaflumuron

, an insect growth regulator that is almost identic al in structure to
noviflumuron. Risk quotients generated using these data would exceed the chronic level
of concern

.

Data Gaps Relative to Listed Species

Listed terrestrial vertebrate predator risks from exposure to noviflumuron through consumption
of termites has resulted in the recommendation for avian reproduction data to fill an important gap in the effects data set. In addition

, there are no available effects data to address noviflumuron risk to listed invertebrate predators that may exploit termites as a food source. However, the following would suggest that such exposure pathways are not reasonably expected

to occur.

The list of terrestrial invertebrates extracted (Appendix A) from US Fish and Wildlife listings o f threatened and endangered species reveals many species that are subterranean cave dwellers
and /or non

- predator s . These species can be eliminated from concern as they are not reasonabl y expected to have a complete exposure pathway to noviflumuron via the consumption of termites

. Similarly

, there are a variety of emergent aquatic invertebrate predators (e

. g. damsel and dragonfly species) whose main food source as adult s is flying insects. These organisms are not18

reasonably expected to be exposed to noviflumuron in worker termites because they are ground dwelling. Consumption of nov iflumuron tainted flying termite al ates also is not expected because
noviflumuron would h ave prevented the metamorphos is of immature alates to the adult stage in
noviflumuron treated termite ne sts

.

The process to this point leaves a list of five predatory beetles and one spider , which, if noviflumuron treated termites were present in their habitat, could be potentially at risk from exposure via termite worker predation. A consideration of habitat requirements for these species was made referencing US Fish and Wildlife documents:

Ohlone tiger beetle Cicindela ohlone ; The habitat of the Ohlo ne tiger beetle includes coastal terraces with remnant stands of open native grassland. Soils at these level or nearly level sites are shallow, poorly drained, pale clay or sandy clay soils over bedrock
of Santa Cruz mudstone. http://ecos.fws.gov/docs/recovery_plan/980928a.pdf

Delta green ground beetle Elaphrus viridis : T he habitat is wetland areas

. http://ecos.fws.gov /docs/five_year_review/doc2384.pdf

Northeastern beach tiger beetle Cicindela dorsalis dorsalis : T he habitat is beach are a s

. http://ecos.fws.gov/docs/recovery_plan/940929b.pdf

Puritan tiger beetle Cicindela puritana : The habitat is beaches and corresponding bluf f
faces

, and the riparian areas of rivers. http://ecos.fws.gov/docs/recovery_plan/930929a.pdf

Salt Creek tige r beetle Cicindela nevadica lincolniana : T he habitat is very specific and occurs in saline wetlands on exposed saline mud flats or along mud banks of streams and seeps that contain salt deposits and are sparsely vegetated

. http://ecos.fws.gov/docs/recovery_plan/Salt%20Creek%20Tiger%20Beetle%20recovery %20outline_02

- 20

- 2009.pdf

S pruce

- fir moss spider Microhexura montivaga : The habitat is associated with moderately thick and humid, but well

- drained, moss and liverwort mats growing in
sheltered spots on surfaces of rock outcrops and boulders in mature high

- elevation forests dominated by Fraser fir (

Abies fraseri ) http://www.gpo.gov/fdsys/pkg/FR

- 2000

- 10

- 06/pdf/00

- 25671.pdf#page=1

The habitat requirements for each of the five beetle species are not consistent with the expected areas immediate to the periphery of buildings where soil conditions supporting active termite colonies would necessitate noviflumuron bait placement. Therefor e, it is not reasonable to expect a complete noviflumuron exposure pathway via consumption of treated termites.

In conclusion data requirement for avian reproduction will be important for evaluating risks to listed birds and herps but the requirements for honeybees are not necessary for evaluating effects
to listed terrestrial invertebrates.19

Table 11

- 2 . Submitted Terrestrial Ecological Effects Data for Noviflumuron

OCSPP
Guideline Data

Requirement Source

MRID Classification Data gap? Are Data Needed

to Conduct the
Risk
Assessment? Justification and Assumptions

EPA Will Make in the Absence
of Data

850.2100 Avian oral

toxicity 45232406

(upland game) Acceptable No No

--

No data (passerine) NA Yes Yes Acute oral toxicity data for a passerine species are required
under the new 40 CFR Part 158. A study has not been submitted for this data requirement.

A guideline

- compliant passerine acute oral toxicity test is needed. Acute oral toxicity data are only available for one avian species ( i.e. , bobwhite quail). Passerine birds may utilize metabolic pathways that are different from larger birds and therefore be more
sensitive to noviflumuron. Furthermore, passerines exhibit behavioral responses to pest icide dosing that are potential indicators of reduced fitness in the field ( e.g. , regurgitation of contaminated diet) even when direct biochemically

mediated lethal toxicity is not
apparent.

In the absence of these data, passerine toxicity data for

surr ogate pesticides

– starting with data for closely related insect growth regulators pesticides and proceeding to data for less related pesticides

– may be used to characterize the acute toxicity of noviflumuron to passerine species.

850.2200 Avian dietary

toxicity 45516722

(upland game) Acceptable No No

--

435516721 (waterfowl) Acceptable

850.2300 Avian

reproduction 42495601

(upland game) NA Yes Yes Avian Reproduction toxicity data are required under the new 40 CFR Part 158. A study has not
been submitted for this data requirement. In the absence of these data, reproduction data for
surrogate pesticides (e.g, 42661001 (waterfowl) NA20

OCSPP
Guideline Data

Requirement Source

MRID Classification Data gap? Are Data Needed

to Conduct the
Risk
Assessment? Justification and Assumptions

EPA Will Make in the Absence
of Data

hexaflumuron)

– starting with data for closely related inse ct growth regulators pesticides and proceeding to data for less related pesticides

– may be used to
characterize the reproduction toxicity of noviflumuron to avian species

850.3020 Honey bee

adult acute

contact toxicity No data NA Yes No Acute contact with this pesticide is not expected for insect predators
of termites.

Non

guideline Honey bee

adult acute oral toxicity No data NA Yes No H oneybees per se are not expected to be exposed

. An analysis of the Federally listed threatened and endangered terrestrial invertebrates
indicates that there is no reasonable complete exposure pathway to these organisms as
well. Non

guideline Honey bee

adult chronic oral toxicity No data NA Yes No

Non

guideline Larval honey

bee acute oral toxicity No data NA Y es No

NA = not applicable21



### 12 References

Carroll C.R. and Janzen D.H. 1973. Ecology of foraging by ants. Annu.Rev. Entomol. 4: 231

– 257

Davidson D.W. 1997. Foraging ecology and community organization in desert seed

- eating ants. Ecology 58: 725

– 737

Hçlldobler B. and Lumsden C.J. 1980. Territorial strategies in ants. Science 210: 732

– 739

McIver J.D. 1991. Dispersed central place foraging in Australian meat ants. Insect. Soc. 38: 129

– 137

Oster G.F. and Wilson E.O. 1978. Caste and Ecology in the Social Insects. Princeton University Press, Princeton, New Jersey. 252 pp

Pasteels J.M., Deneubourg J.

- L. and Goss S. 1987. Self

- organization mechanisms in ant societies. (I) Trail recruitment to newly discovered food sources. In: From Individual to
Collective Behavior in Social Insects (J.M. Pasteels and J.

- L. Deneubourg, Eds). Birkh_user, Basel, pp 43

– 61

Traniello J.F.A. 1983. Social organization and foraging success in Lasius neoniger (Hymenoptera: Formicidae) : Behavioral and ecologicalaspects of recruitment communication. Oecologia 59: 94

– 100

USEPA 2003. Section 3 Request for Use of Noviflumuron (PC Code: 118204) in a Bait Formulation to Control Termites. Data Package Barcode: 285883, 288937. Environmental Fate and Effects Division, Office of Pesticide Programs, United States Environmental Protection Agency.

USEPA. 1993. Wildlife Exposure factors handbook. EPA/600/R

- 93/187. Office of Research and Development. United States Environmental Protection Agency.

USEPA. 2005. Section 3 New Use Request for Use of Noviflumuron in a Gel Bait Formulation to Control Cockroaches and Foraging Subterranean Termites. Data Package Barcode: 307981. Environmental Fate and Effects Division, Office of Pesticide Programs, United States Environmental Protection Agency.

Wood T.G. and Sands W.A. 1978. The role of termites in ecosystems. In: Production Ecology of Ants and Termites (M.V. Brian, Ed), Cambridge University Press, U.K., pp 245

– 292

Zhou, X., Wheeler, M.M. Wheeler , F.M

. Oi , and M.E. Scharf. 2008. RNA interference in the termite Reticulitermes flavipes through ingestion of double

- stranded RNA. Insect Biochemistry and Molecular Biology, 38 (8): 805

- 815.22



### 13 Bibliography:

Environmental Fate Studies

45232421 Cook, W. (1999) Hydrolysis of XDE

- 007 at pH 5, 7, and 9 at 25 (degrees

centigrade) and 50 (degrees centigrade): Lab Project Number: 990050. Unpublished study prepared by The Dow Chemical Company. 53 p.

45516708 Byrne, S. (2001) Aerobic Soil Degradation o f 14C

- XDE

- 007: Lab Project

Number: 990042. Unpublished study prepared by Dow AgroSciences LLC. 66 p

45232422 Balcer, S. (1999) Probe Aerobic Soil Metabolism Study XR

- 007: Lab Project

Number: GH

- C 4897. Unpublished study prepared by Dow AgroSciences LLC.

3 8 p.

45516709 Byrne, S. (2001) Batch Equilibrium Adsorption and Desorption of 14C

- XDE

- 007

in Eight Soils: Lab Project Number: 000418. Unpublished study prepared by Dow AgroSciences LLC. 88 p.

Ecological Effects Studies

45232406 Kaczor, M.; Miller, V. (2000) XDE

- 007: 14

- Day Avian Acute Oral Toxicity Test

with Northern Bobwhite (Colinus virginianus): Lab Project Number: 030008: 000028. Unpublished study prepared by EBA, Inc. 40 p.

45516721 Miller, V. (2001) XDE

- 007

-- Dietary Toxicity Test with the Mallard Duck (Anas

platyrhynchos): Lab Project Number: 12550.4103: 010009. Unpublished study prepared by Springborn Laboratories, Inc. 96 p.

45516722 Miller, V. (2001) XDE

- 007

-- Dietary Toxicity Te st with the Northern Bobwhite

Quail (Colinus virginianus): Lab Project Number: 010010: 12550.4102. Unpublished study prepared by Springborn Laboratories, Inc. 102 p.23



### 14 Labels Summary Table

Use Product Name Reg. No. Method of Application Maximum

Application Rate (ai g/application site or bait tube)

Termites subgroup;
subterranean
termites Recruit IV 62719

- 453 Bait tube (in

ground, above ground, in existing structure) 2 tubes / site

Termites subgroup;
subterranean
termites Recruit IV AG 62719

- 454 Bait tube (in

ground, above ground, in existing structure) 2 tubes/ site

Termites subgroup;
subterranean
termites Recruit HD

AG 62719

- 652 Bait tube (in

ground, above ground, in existing structure) 2 tubes/ site

Termites subgroup;
subterranean
termites Recruit HD 62719

- 608 Bait tube (in

ground, above ground, in existing structure) 2 tubes/ site

Termites subgroup;
subterranean
termites Recruit HD2 62719

- 608 Bait tube (in

ground, above ground, in existing structure) 2 tubes / site

Termites subgroup;
subterranean
termites GF

- 1252 62719

- 520 Crack and crevice gel applicator 1 app at 0.01g/ site

Cockroaches GF

- 1252 62719

- 520 Crack and crevice gel applicator 1 app at 0.025g/ site

Cockroaches GF

- 1252 62719

- 520 Gel applicator in
bait tube 1 app 0.025g/ station

Insecticide Noviflumuron

Technical 62719

- 452 N/A N/A (Technical Use) Insect growth regulator XDE

- 007 50%

Concentrate 62719

- 478 N/A N/A (Manufacturing Use)24

Assumptions/Limitations:
i) All end use formulations based on an “as needed” use basis. Applications during initial discovery of infestation may be more frequent than the monitoring recommended, and are re

- applied as necessary when bait is depleted by animals. Min application interval not specified. ii) Rate not specified on G F

- 1252 (EPA Reg. No. 62719

- 520) label for crack and crevice gel applicator on cockroaches, rate assumed based on amount for bait station. iii) Tubes are placed around affected area not to exceed 20 feet apart. Minimum distance between bait tubes
not stated for Recruit IV, Recruit IV AG, Recruit HD AG, Recruit HD, and Recruit HD2 labels. iv) Application rates in grams of active ingredient per bait tube not clear for Recruit IV, Recruit IV AG, Recruit HD AG, Recruit HD, and Recruit HD2 labels. N/A: Not Applicable.25 Appendix A Federally L isted Terrestrial Invertebrate Species E valuated

Inverted
Common Name Scientific Name Listing Status Potential for complete

exposure pathway Rational e

Harvestman, Bee
Creek Cave Texella reddelli E No Subterranean

Harvestman,
Bone Cave Texella reyesi E No Subterranean

Pseudoscorpion,
Tooth Cave Tartarocreagris

texana E No Subterranean

Spider, Tooth

Cave Leptoneta

myopica E No Subterranean

Beetle, Coffin
Cave mold Batrisodes

texanus E No Subterranean

Beetle,
Kretschmarr
Cave mold Texamaurops

reddelli E No Subterranean

Beetle, Tooth Cave ground Rhadine

persephone E No Subterranean

Beetle, Comal Springs dryopid Styg oparnus

comalensis E No Aquatic

Beetle, Comal Springs riffle Heterelmis

comalensis E No Aquatic

Harvestman, Cokendolpher

Cave Texella

cokendolpheri E No Subterranean

Meshweaver,
Braken Bat Cave Cicurina venii E No Subterranean

Meshweaver,

Government Canyon Bat
Cave Cicurina vespera E No Subterranean

Meshweaver,
Madla's Cave Cicurina madla E No Subterranean

Meshweaver,
Robber Baron

Cave Cicurina baronia E No Subterranean

Spider,

Government Canyon Bat
Cave Neoleptoneta

microps E No Subterranean

Beetle, Helotes
mold Batrisodes

venyivi E N o Subterranean

Ground beetle, Rhadine exilis E No Subterranean26

[unnamed]
Ground beetle, [unnamed] Rhadine infernalis E No Subterranean

Butterfly,
mission blue Icaricia icarioides

missionensis E No Herbivore

Butterfly, San
Bruno elfin Callophrys mossii

bayensis E No Herbivore

Butterfly, Schaus
swallowtail Heraclides

aristodemus

ponceanus E No Herbivore

Damselfly,
blackline
Hawaiian Megalagrion

nigrohamatum nigrolineatum E No Aerial feeder

Damselfly,
crimson
Hawaiian Megalagrion

leptodemas E N o Aerial feeder

Damselfly,
oceanic
Hawaiian Megalagrion

oceanicum E No Aerial feeder

Damselfly, flying earwig
Hawaiian Megalagrion

nesiotes E No Aerial feeder

Damselfly,
Pacific Hawaiian Megalagrion

pacificum E No Aerial feeder

Pomace fly, [unnamed] Drosophila aglaia E No Herbivore

Pomace fly, [unnamed] Drosophila

differens E No Herbivore

Pomace fly, [unnamed] Drosophila

hemipeza E No Herbivore

Pomace fly, [unnamed] Drosophila

heteroneura E No Herbivore

Pomace fly, [unnamed] Drosophila

montgomeryi E No Herbivore

Pomace fly, [unnamed] Drosophi la mulli T No Herbivore

Pomace fly, [unnamed] Drosophila

musaphilia E No Herbivore

Pomace fly, [unnamed] Drosophila

neoclavisetae E No Herbivore

Pomace fly, [unnamed] Drosophil a obatai E No Herbivore

Pomace fly, [unnamed] Drosophila

ochrobasis E No Herbivore

Pomace fly, [unnamed] Drosophila

substenoptera E No Herbivore27

Pomace fly, [unnamed] Drosophil a

tarphytrichia E No Herbivore

Grasshopper, Zayante band

- winged Trimerotropis

infantilis E No Herbivore

Tiger beetle,
Ohlone Cicindela ohlone E No Habitat not
consistent with
use site Spider, Kauai cave wolf or pe'e pe'e maka 'ole Adelocosa anops E No Subterranean

Spider, spruce

- fir moss Microhexura

montivaga E No Habitat not
consistent with
use site Beetle,
American burying Nicrophorus

americanus E No Carrion feeder

Beetle, delta green ground Elaphrus viridis T No Habitat not
consistent with
use site Beetle, Hungerford's crawling water Brychius

hungerfordi E No Aquatic

Beetle, valley elderberry longhorn Desmocerus

californicus dimorphus T No Herbivore

Butterfly, bay checkerspot Euphydryas

editha bayensis T No Herbivore

Butterfly,
Behren's silverspot Speyeria zerene

behrensii E No Herbivore

Butterfly, callippe silverspot Speyeria callippe

callippe E No Herbivore

Butterfly, El Segundo blue Euphilotes

battoides allyni E No Herbivore

Butterfly,
Fender's blue Icaricia icarioides

fenderi E No Herbivore

Butterfly, Karner
blue Lycae ides melissa

samuelis E No Herbivore

Butterfly, Lange's
metalmark Apodemia mormo

langei E No Herbivore

Butterfly, lotis
blue Lycaeides

argyrognomon lotis E No Herbivore28

Butterfly, Miami
Blue Cycla rgus

(=Hemiargus)
thomasi
bethunebakeri E No Herbivore

Butterfly, Mitchell's satyr Neonympha

mitchellii
mitchellii E No Herbivore

Butterfly, Mount
Charleston blue Plebejus shasta

charlestonensis E No Herbivore

Butterfly, Myrtle's silverspot Speyeria zerene

myrtleae E No Herbivore

Butterfly, Oregon silverspot Sp eyeria zerene

hippolyta T No Herbivore

Butterfly, Palos
Verdes blue Glaucopsyche

lygdamus palosverdesensis E No Herbivore

Butterfly, Quino checkerspot Euphydryas

editha quino (=E. e. wrighti) E No Herbivore

Butterfly, Saint Francis' satyr Neonympha

mitchellii
francisci E No Herbivore

Butterfly,
Smith's blue Euphilotes

enoptes smithi E No Herbivore

Butterfly, Uncompahgre fritillary Boloria

acrocnema E No Herbivore

Checkerspot, Taylor's (=whulge) Euphydryas

editha taylori E No Herbivore

Dragonfly,
Hine's emerald Somatochlora

hineana E No Aerial feeder

Fly, Delhi Sands
flower

- loving Rhaphiomidas

terminatus
abdominalis E No Herbivore

Fly, Hawaiian picture

- wing Drosophila

digressa E No Herbivore

Fly, Hawaiian picture

- wing Drosophila sharpi E No Herbivore

June Beetle, Caseys Dinacoma caseyi E No Herbivore

Moth,
Blackburn's sphinx Manduca

blackburni E No Herbivore29

Moth, Kern primrose sphinx Euproserpinus

euterpe T No Herbivore

Naucorid, Ash
Meadows Ambrysus

amargosus T No Herbivore

Skipper, Carson wandering Pseudocop aeodes

eunus obscurus E No Herbivore

Skipper, Laguna
Mountains Pyrgus ruralis

lagunae E No Herbivore

Skipper, Pawnee

montane Hesperia

leonardus

montana T No Herbivore

Tiger beetle,
Northeastern
beach Cicindela dorsalis

dorsalis T No Habitat not
consistent with
use site Tiger beetle,
Puritan Cicindela puritana T No Habitat not
consistent with
use site Tiger beetle, Salt
Creek Cicindela

nevadica
lincolniana E No Habitat not
consistent with
use site June Beetle, Caseys Dinacoma caseyi E No Herbivore

Butterfly, cassius
blue Leptotes cassius

theonus SAT No Herbivore

Butterfly,
ceraunus blue Hemiargus

ceraunus antibubastus SAT No Herbivore

Butterfly,
nickerbean blue Cyclargus ammon SAT No Herbivore