### 1 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON

, D.C. 20460

Date: February 26, 2015 PC Code: 124002 MEMORANDUM DP Barcode: D422123

SUBJECT: Registration Review: Preliminary Problem Formulation for Environmental Fate, Ecological Risk, Endangered Species, a nd Drinking Water Exposure Assessments for Novaluron

FROM: Ryan Mroz, Biologist He Zhong, Ph.D., Biologist Environmental Risk Branch I Environmental Fate and Effects Division (7507P)

THROUGH: Sujatha Sankula, Ph.D., Branch Chief Environmental Risk Branch I Environmental Fate a nd Effects Division (7507P)

TO: Meg Hathaway, Chemical Review Manager Tom Myers, Team Leader Kevin Costello, Branch Chief Risk Management and Implementation Branch II Pesticide Re-Evalua tion Division (7508P)

### 2 

# Table	of Contents

1. Executive Summary ............................................................................................................. ... 3 2. Introduction .................................................................................................................. ........... 3 3. Use Characterization .......................................................................................................... ..... 5 4. Conclusions from Previous Risk Assessments ....................................................................... 6

a. Ecological Risk Assessment .................................................................................................. 6 b. Drinking Water Exposure Assessments ................................................................................. 7

c. Clean Water Act Programs .................................................................................................... 7 5. Environmental Fate and Transport.......................................................................................... 7

a. Transformation Products ...................................................................................................... 10 6. Receptors...................................................................................................................... ......... 11

a. Effects to Aquatic Organisms .............................................................................................. 11 b. Effects to Terrestrial Organisms .......................................................................................... 16

c. Degradates .................................................................................................................... ........ 19 d. Ecological Incidents .......................................................................................................... ... 21 7. Exposure Pathways of Concern ............................................................................................ 21 8. Analysis Plan ................................................................................................................. ....... 22

a. Stressors of Concern .......................................................................................................... .. 22 b. Measures of Exposure .......................................................................................................... 23

c. Measures of Effect ............................................................................................................ ... 23 9. Endangered Species Assessments ......................................................................................... 23 10. Endocrine Disruptor Sc reening Program .............................................................................. 23 11. Preliminary Identificati on of Data Gaps ............................................................................... 24

a. Environmental Fate ............................................................................................................ .. 24 b. Ecological Effects ............................................................................................................ .... 25 12. References .................................................................................................................... ...... 36 Appendix 1. Novaluron Uses and Application Rates ................................................................ 46 Appendix 2. Previous Actions for Uses of Novaluron .............................................................. 50 Appendix 3. Structures of Nova luron and its Degradates .......................................................... 55 Appendix 4. Major Degradates Chlorophenyl Urea and Chloroaniline .................................... 56 Appendix 5. Screening Level Models to Evalua te Potential Importance of Drinking Water and Inhalation Exposure Pathways .................................................................................................. .. 58

### 3 

# 1. Executive Summary

The Environmental Fate and Effects Division (EFE D) has completed the problem formulation for the ecological risk, environmental fate, endangere d species, and drinking water assessments to be conducted as part of the registration review of novaluron (PC Code 124002). The problem formulation describes the methods planned to be used during the completion of the drinking water and ecological risk assessments in support of regi stration review and provi des an overview of the environmental fate, ecological eff ects, and potential risks associat ed with the use of novaluron as well as uncertainties unique to th e risk assessment of novaluron. Th is document also identifies additional studies that would be beneficial to conducting an ecol ogical risk assessment. Major findings include:

The following environmental fate data gaps were identified:

 850.6100- ECM/ILV (soil and water) for pa rent and two metabolites (TGAI) The following ecotoxicity data gaps and un certainties were identified for the parent novaluron (see Section 11b for details):

 850.1400 - Saltwater fish early-life stage

 850.1740 - Whole sediment – chronic freshw ater invertebrates – TGAI with Leptocheirus plumulosus

 Non-guideline - Whole sediment – chronic freshwater invertebrates – TGAI with Hyalella azteca

 850.4100 - Seedling Emergence and Seedling Growth

 850.4150 - Vegetative Vigor850.4500/850.4550 - Non- vascular plant toxicity – Study with both a freshwater diat om, and estuarine/marine diatom

 Non-guideline - Honeybee larval chronic toxicity (including acute endpoints) The following ecotoxicity data gaps and uncer tainties were identified for the degradates chlorphenyl urea and chloroaniline (see Section 11b for details):

 850.1075 - Freshwater fish acute toxicity – Chlorphenyl urea

 850.1300 - Freshwater invertebrate li fe cycle - Chloroaniline

 850.1350 - Saltwater invertebrates life cycle - Chlorphenyl urea and chloroaniline

 850.1400 - Freshwater fish early-life stage – Chlorophenyl urea

 850.4400 - Aquatic plant Toxicity Test using Lemna spp. – Chlorophenyl urea

 850.4500/850.4550 - Non-vascular plant toxicity – Chlorphenyl urea (freshwater diatom, and estuarine/marine diatom) and Chloraniline (algae) Many of the labels for non-agricultural uses did not provide info rmation on the maximum number of applications allowe d per year, the maximum annual ra te (in terms of lbs ai/A), or the minimum re-application interval. If th e labels are not clarif ied, assumptions will be made based on the missing interval(s) for these uses as outlined in Appendix 1.



# 2. Introduction Novaluron is a non-systemic insecticide insect gr owth regulator (IGR) in the benzoylphenyl urea family of chemicals. Novaluron inhibits ch itin biosynthesis and cuticle formation in molting/developing insects and leads to abnormal endocuticular deposition, abortive molting, and adverse effects on insect growth and development. Novaluron has no effect on adult insects which have completed all successive molts. Novaluron acts primarily by ingestion, but also has some

### 4 contact activity. Novaluron is a chiral co mpound containing a racemic mixture of two enantiomers (R,S).

Novaluron is formulated as an emulsifiable conc entrate, suspension concentrate, flowable, water dispersible granule, bait cartridge, pellet, granule, and ready to use solution depending on the use. Applications are made manually (b ait, spot/crack crevice, spot- on, cattle and poultry operations), aerially (broadcast), by ground (broadcast, band, dire ct spray, chemigation, and spot treatment), and directly to water (granule for mosquito contro l). Some pellets/tablets are applied directly to standing water that is disconnected from natural water ways (bird baths, swimming pool covers, boat covers, etc.) for mosquito control. The ma ximum single application rate for non-agricultural uses is 0.872 lb ai/A (14.83 lb ai/A yearly) as a dry scattering treatment for beetles in poultry operations, while the maximum agriculture use is a single application of 0.32 lb ai/A for pome fruits, excluding pears (0.97 lb ai/A yearly). (Appendix 1).

Novaluron has a variety of both agricultural crops and non-agricultural crop uses. Agricultural crop uses include: alfalfa, apples , blueberries, cabbage, cauliflower, cotton, dry beans/peas, pears, peppers, potatoes, strawberries, and tomatoes. Non- agricultural uses include ornamental shrubs and bushes, turf as well as residential use for co ntrol of crickets and mosquitoes in small water bodies. According to the Biological and Economic s Analysis Division (BEAD), application to cotton at an average rate of 20,000 lbs per year is the highest use followed by apples at 9,000 lbs per year on average (USEPA 2014a). Table 2.1 shows the agricultural uses in terms of average annual application (data from 2004 through 2012).

Table 2.1. Average Annual Novaluron Agricu ltural Uses (data from 2004 through 2012).

Percent Crop Treated

Crop Average Lbs. ai Average Maximum

1 Alfalfa <500 <1 <2.5 2 Apples 9,000 10 20 3 Blueberries <500 <1 <2.5 4 Cabbage <500 5 15 5 Cauliflower <500 <2.5 5 6 Cotton 20,000 <2.5 10 7 Dry Beans/Peas <500 <1 <2.5 8 Pears 3,000 15 25 9 Peppers <500 <2.5 <2.5 10 Potatoes 1,000 <2.5 5 11 Strawberries 3,000 35 55 12 Tomatoes <500 <2.5 <2.5



### In addition to novaluron-only products, novaluron is also formulated with other insecticides including: pyriproxyfen (also an insect growth regulator) and bife nthrin (a pyrethroid insecticide (Appendix 2).

### 5 EFED evaluated the most recent ecological risk assessments fo r novaluron in association with updated toxicity, exposure, and usage information to determine if sufficient data are available and if further updates are needed to support registra tion review. The most recent risk assessment is from 2013 for the use of novaluron as spot and perimeter treatments in animal husbandry or residential scenarios and included: outdoor flea c ontrol, outdoor cockroac h perimeter treatment, outdoor control of litter beetles in chicken houses , outdoor control of ants, outdoor control of flying insect pests 

### , indoor control of litter beetles in chicken houses

, cattle and horse operations (flies ), and poultry operations (beetles) 

### (D409223 and D412299). In addition, EFED considered the latest Agency science policies and risk assessment me thodologies. The structure of novaluron and its degradates, as well as the chemical names and other identifiers, can be found in the chemical identity table attached to this document (Appendix 3).



# 3. Use Characterization

Novaluron is a non-systemic benzoylphenyl urea in sect growth regulator (IGR) used to control insects belonging to the orders Co leoptera, Diptera, Hemiptera, and Lepidoptera via inhibition of cuticle formation. It is registered for use on a variety of row crops, vegetables, tree crops, ornamentals, turf, and animal husbandry practices (see Appendix 1 for a full list). There is one active technical registration for nova luron, which is formulated into 17 active registered end-use products as emulsifiable concentr ate, suspension concentrate, flow able, water dispersible granule, bait cartridge, pellet, granule, and ready to use solution. The chemical profile produced by BEAD, located on Regulations.gov in the registrati on review docket for n ovaluron, lists the use patterns of maximum exposures for the current uses of novaluron. EFED will use application scenarios that result in maximu m exposure scenarios for a given use for the risk assessment. Failure of the label to specify the maximum singl e application rate, the application interval, the annual maximum rate (lb ai/A/year), and appl ication method may result in conservative assumptions.

For novaluron, several label issues were identified. Appendix 1 has more details on missing information and assumptions which may be made based on missing information:

 Seasonal, rather than yearly application info rmation is provided for many of the uses on registration numbers 499- 557, 53883-306, 53883-344, 66222-217, 66222-231, 66222- 232). The number of applications and the ma ximum application rate should be reported on an annual basis. In the absence of yearly information, multiple seasons or crop cycles may be assumed for some crops when perfor ming the risk assessment, based on input from the Biological and Economic s Analysis Division (BEAD).

 Several uses for insect control did not pr ovide a clear maximum annual rate or retreatment interval between applications. Assumptions will be made on the maximum yearly rate based on how long the label languag e states insects are controlled for and how many reapplications at those in tervals would fit into a year.

 Registrations 53883-306, 53883-344, and 53883-355 do not list the number of applications per year. The number will be ca lculated based on the minimum re-treatment interval.

### 6  Several registrations are gra nular formulations. Informa tion on the size of the granule and the amount of novaluron contained within the granule is needed for the risk
assessment.


# 4. Conclusions from Previous Risk Assessments

a. Ecological Risk Assessment The Agency has conducted multiple ecological risk assessments on novaluron that serve as a basis for this problem formulation. The most recent comprehensive risk assessment was completed on August 14, 2013 (USEPA, 2013b; D409223 and 412299) for the following uses: Outdoor flea control, outdoor cockroach peri meter treatment, outdoor control of litter beetles in chicken houses , outdoor control of ants, outdoor control of flying insect pests 

### , indoor control of litter beetles in chicken houses

, cattle and horse operations (flies), and poultry operations (beetles) 

### . Data used in that assessment indicated that novaluron’s degrad ates, chlorophenyl urea and chloroaniline, are more toxic to both freshwater fi sh and aquatic non-vascular plan ts than the parent novaluron . It is uncertain if chlorophenyl urea or chloraniline is more toxic, so the previous assessment assumed the degradates had equal toxicity when compared to the other. 

### Potential direct risk concerns from that assessment were identified for the taxa below:

 Birds (chronic and dietary [Bioc oncentration Factor (BCF) based])

 Terrestrial invertebrates (presumed)

 Terrestrial and semi-aquatic plants (presumed from lack of data)

 Benthic invertebrates (acute and chronic)

 Estuarine/marine fish (chronic assumed from lack of data)

 Aquatic vascular plants (not pr ecluded for degradates only)

Data gaps from the 2013 assessment were identified for novaluron below:

 850.4100 - Seedling Emergence

 850.4150 - Vegetative Vigor

 Non-guideline Honeybee Larval Toxicity Test

 850.1400 - Estuarine/Marine Fish Life-Cycle

In addition, co-formulations with additional insec ticides could pose additional risks/stress, either additive or synergistic, to bot h larval and adult honeybees. For example, novaluron is coformulated with both pyriproxyfen and bifenthrin. Pyriproxyfen, also an IGR, and could adversely affect larval honeybees/non-target insects and bifenthrin has been identified as highly toxic (LD 50 

### of 0.015 mg a.i./bee) to adult honeybees. A Reregistration Elig ibility Decision (RED) was not completed for novaluron. Table 4.1 below identifies risk concerns and issues from all previous assessments of novaluron.

Table 4.1. Summary of Risk Concerns and Issues Identified for Novaluron in Previous Assessments

Birds Mammals Terr. Plants Terr. Inverts Fish BCF Aquatic Inverts Aquatic Plants Groundwater Contamination Persistence Degradates of Concern
Yes 1 Yes 1 Yes 2 Yes 2 Yes 2 Yes Yes Yes 3 Yes Yes Yes 4

“Yes” = Risk concerns or issues were identified or presumed from lack of data in previous assessments;

### 7 1 = Chronic

2 = Presumed due to lack of data. Fi sh encompasses estuarine/marine only

3 = Not precluded (for degradates only)

4 = Two degradates of concern chlorphenyl urea and chloroaniline exist for novaluron. For aquatic uses these degradates were modeled separately from the parent novaluron in previous ecological risk assessments.



## b. Drinking Water Exposure Assessments The most recent drinking water assessment fo r novaluron was conducted to support the IR-4 petition for the proposed new uses on various ag ricultural crops and re sidential ornamentals (USEPA 2014b; D418740). In this assessmen t, EFED recommended the surface water upper bound the estimated drinking water concentrations (EDWC) for novaluron, chlorophenyl urea and chloroaniline from the pr evious assessments (USEPA 2013a, D412441; USEPA 2009b; D363989+). The surface water upper bound EDWCs are listed in Table 4.2.

Table 4.2

. The Upper Bound EDWCs for Novaluron, Chlorophenyl Urea and Chloroaniline

Acute ( μ g/L) Non-cancer Chronic ( μ g/L) Cancer Chronic ( μ g/L)
Novaluron (PA Apples) 3* 0.76 0.62

Chlorophenyl Urea (Poultry litter use) 8.77 6.01 3.21

Chloroaniline (Poultry litter use) 12.59 10.05 6.05

* Novaluron solubility limit



### In addition, EFED recommended the estimated concen trations of novaluron and two degradates in ground water sources with the peak EDWCs not to exceed 8.72 x 10 -2 

### μ g/L
, 0.43 μ g/L and 84.2
μ g/L for novaluron, chlorophenyl urea, a nd chloroaniline, respectively.



## c. Clean Water Act Programs Novaluron is not identified as a cause of impair ment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 1 

### . No Total Maximum Daily Load (TMDL) criteria have been developed for novaluron. Aquatic benchmarks have been established for novaluron and are available at http://www.epa.gov/ oppefed1/ecorisk_ders/a quatic_life_benchmar k.htm. Any data submitted or otherwise located as part of the re gistration review process may be used to update aquatic life benchmarks if applicable.



# 5. Environmental Fate and Transport

Novaluron is a chiral compound containing a race mic mixture of two enantiomers (R,S). The available environmental fate and ecological effect s data on novaluron represents only the racemic mixture. Based on submitted environmental fate data and reported physical-chemical properties novaluron is not mobile and stable to hydrolysis and photolysis ( Table 5.1 ).

Novaluron has low vapor pressure (1.2 x 10 -7 

### mm Hg), low water solubility (3 ppb), and high soil adsorption coefficient (K oc 

### = 6,680 - 11,813). The low water solubility plus high soil adsorption

1 http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/

### 8 coefficient indicates novaluron's strong adsorption to soil and its limited ability to leach into groundwater. Novaluron is stable to hydrolysis (T 1/2 

### = 101 days), soil photolysis (T 1/2 

### = 257 days), and aqueous photolysis (T 1/2 

### = 187 days). The extrapolated degradation half-lives (DT 50 

### ) are well beyond the duration of study periods (hydrolysis 30 days and photolysis 15 days).

Novaluron degradation in soil and water is co ntrolled by microbial-mediated processes. Soil degradation half-lives range from 7-32 days to form chlorophenyl urea (275-352I) and chloroaniline (275-309I) (MRIDs: 44961009 and 44961010). Aqueous degradation half-lives range 10-51 days (MRIDs: 45638205, 45638206 and 45789203). Laboratory and field studies indicate runoff of entrained sediments is th e most likely dissipation pathway for off-site movement of novaluron. During surface runoff conditions, novaluron may reach water bodies bound to soil particles and will like ly partition into sediments once in surface water. In a field dissipation study conducted in Nort h America, novaluron residues were not detected above 0.09 ppm (Nova Scotia) in the 15-30 cm soil depth an d above 0.06ppm (Ontario) in the 30-45 cm soil depths (MRID 45789204). Novaluron (RIMON® SU PRA 10EC ) was not detected above the LOQ (10 ppb) at any sampling inte rval or in any replicate sample in the 10-20 cm soil depth when applied to bare soil in Spain and Germa ny (MRID 45638403). In a microcosm study, novaluron exhibited water column DT 90 

### values ranging from 12 to 20 da ys for three different test concentrations ( i.e. , 5, 15, and 50 g ai/ha treatment level and the main degradate, chlorophenyl urea (275-352I) was found in th e water column (MRID 45785801).

Novaluron (log Kow = 5.26) appears to accumulate in edible and non-edible fish tissues. In a standard bioconcentration study using the bluegill sunfish, the highest bioconcentration factor (BCF) in whole fish was 14,431x. The half-life for cl earance of residues in the bluegill was 3.9 to 7.3 days for whole fish (MRID 45638215).

Table 5.1. Environmental Fate and Transport Properties of Novaluron

Parameters Value and Unit Reference

PC Code 124002 CAS Number 116714-46-6 Toxnet Chemical (CAS) Name 3-Chloro-4-[I, 1,2- trifluoro-2- (trifluoromethoxy)ethoxy]p

henyl] -amino]carbonyl]- 2,6- difluorobenzamide IUPAC Name RS)-1-[3-Chloro-4 (1,1,2- trifluoromethoxyethoxy)ph enyl]-3-(2,6- difluorobenzoy1) urea Molecular Formula C 17 H 9 ClF 8 N 2 O 4 Product Chemistry, MRID 44961006

Molecular Weight 492.7 Product Chemistry, MRID 44961006

### 9 Parameters Value and Unit Reference

Molecular Structure MRID 45638206

Smiles Fc1cccc(F)c1C(=O)NC(=O )Nc2cc(Cl)c(OC(F)(F)C(F) OC(F)(F)F)cc2 EPI Suite 4.1

Solubility (at 25 o C) 3 μg/L Product Chemistry, MRID 44961006

Vapor Pressure 1.2 x 10 -7 mm Hg Product Chemistry, MRID 44961006

Henry’s Constant at 25 o C 2 x10 -5 atm•m 3 /mol Product Chemistry, MRID 44961006

Log Kow 5.26 EPI Suite 4.1

Soil Partition Coefficient (K d ) 133, 247, 184, and 95 ml/g MRID 44961012

Soil Partition Coefficient (K oc ) 10271, 6650, 9658 and 11813 ml/g MRID 44961012

Aerobic Soil Metabolism T 1/2 Degradates: chlorophenyl urea (maximum of 26.6%@7 days) chloroaniline (maximum of 8.5%@120 days) 11.8 days, 14.5 days, 13.7days and 7 days MRIDs: 44961009 and 44961010

Anaerobic Soil Metabolism T 1/2 Degradates: chlorophenyl urea (maximum of 13.7%@59 days) chlorophenyl aniline (maximum of 5.8%@181 days) 2,6-difluorobenzoic acid (maximum of 48.3%@59 days) 2,6-difluorobenzamide (maximum of 2.5%@181days) 65.8 days, 53.7 days, 42.2 days and 44.7 days MRID 45638205

Aqueous Photolysis (pH 5) T 1/2 Degradates: 187 days MRID 45638203

Photodegradation on Soil 257 days MRID 45638204

Hydrolysis T 1/2 (pH7) stable MRID 44961008 Aerobic Aquatic Metabolism 15.7 days, 23.7 days, 9.72 MRID 45638206

### 10 Parameters Value and Unit Reference

Half-life chlorophenyl urea (maximum of 21.7%@14 days) chlorophenyl aniline (maximum of 4.4%@30 days) 2,6-difluorobenzoic acid (maximum of 0.8%@30 days) 2,6-difluorobenzamide (maximum of 1.4%@30days) days and 9.06 days

Anaerobic Aquatic Metabolism Half-life chlorophenyl urea (maximum of 32.3%@267 days) chlorophenyl aniline (maximum of 49.2%@363 days)
2,6-difluorobenzoic acid (maximum of 93.9%@363 days)
2,6-difluorobenzamide (maximum of 1.7%@91days) 50.6 and <91 days MRIDs: 45638207 and 45789203

Terrestrial field dissipation (US, Canada, Spain, and Germany) 20 - 178 days MRID 45638403

Bioaccumulation in fish BCF = 14,431 MRID 45638215



## a. Transformation Products Novaluron degrades to form chlorophenyl urea and 2,6-difluorobenzoic acid. Hydrolysis of degradation products leads to the formation of chloroaniline from chlorophenyl urea and 2,6 difluorobenzamide from 2,6-difluorobenzoic acid. The major degradates of chlorophenyl urea (275-352I) and chloroani line (275-309I) are metabolites of concerns for ecological risk assessment and were also identified by the H ealth Effects Division (HED) to be of human drinking water concern (USEPA 200 4a, MARC). The chloroaniline moiety may be characterized as a semi-volatile compound base on the vapor pressure (3.49 x 10 -3 

### mm Hg) and is thought to be associated with the most pronounced toxico logical effects of nova luron to mammals.

Chlorophenyl urea occurred in aerob ic soil metabolism at the maximum of 26.6% of the applied parent at 7 days post-treatment. Chlorophenyl urea appears to have low to slight mobility in soil (K oc 

### values range from 1,950 to 2,563) (FAO 2000). Chloroaniline occurred at a maximum of 8.5% of applied in the aerobic soil metabolism study at 120 days post treatment, the last sampling interval (MRID 44961009). Additionall y, it is expected that chloro aniline is formed from the further degradation of the major degradate, chlorophenyl urea (275-352I) (MRIDs: 45638205 and 45789203). In the anaerobic aquatic metabolism study, at the last sampling interval, i.e., 363 days post treatment, a maximum of 32% of the applied occurred in th e soil and 49.8% in the total

### 11 system. A summary of fate and transport proper ties of these two major degradates can found in Appendix 4

. 

# 6. Receptors

Table 6.1 and 6.2 provide a summary of the aquatic and terrestrial taxonomic groups, respectively, and the available endpoints for the most sensitive surrogate species tested to characterize the potential acu te and chronic ecological effects of novaluron. The Agency does not routinely include an evaluation of mixtures of activ e ingredients (either those mixtures of multiple active ingredients in product formulations or those in the applicator’s tank) in its risk assessments. Each active ingredient is subject to an individual risk assessment for a regulatory decision regarding the active ingredient on a particular use site (USEPA 2004b). However, 

### novaluron is also formulated with pyriproxyfen (also an IGR) for insect control in animal husbandry practices a nd bifenthrin (a pyrethroid) for use on cotton. The most recent assessment (D409223) qualit atively discusses the incorporation of this pyriproxyfen mixture data and a qualitative di scussion of implications of the available pesticide mixture effects data regardin g the confidence of risk assessment conclusions will be addressed as part of the uncertainty anal ysis for the bifenthrin formulation. EFED will consider open literature, currently available models and other lines-of-evidence ( e.g. , monitoring data), as available to address the potential for cumulative effects of formulations in the risk description of the ecological assessment for novaluron.

Additionally, although EFED does not normally assess indoor uses, there are some uses, e.g. manure spread in poultry operations, which presen t a potential complete environmental exposure pathway and require special analyses. Specifically, it is expected that the indoor poultry house treatments will result in outdoor exposures to non-target organisms when the poultry litter is removed during sanitization. Similarly, the hay and manure that are cleaned from horse barns represent a complete exposure pathway.

I 

### n general, novaluron is highly to xic to aquatic invertebrates, es pecially benthic invertebrates, which is unsurprising given its mode of action of affecting molting juvenile insects. It generally only affects vertebrates (birds and mammals) on a chronic basis. Honeybee data suggest novaluron is practically non-toxic to adult honeybees on both an oral and contact basis; however, as adult bees do not molt once they reach matu rity and novaluron’s m ode of action targets molting insects, the effect on molting juveniles and larvae is still uncertain.



## a. Effects to Aquatic Organisms

Table 6.1. Summary of the Most Sensitive E ndpoints from Aquatic Toxicity Studies for Novaluron

Taxonomic Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

Freshwater fish 1 Acute Bluegill sunfish

( Lepomis macrochirus ) LC 50 > 0.96 mg ai/L NOAEC = 0.96 mg ai/L

No effects --^ 45499005

Supplemental

### 12 Taxonomic Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

Acute Rainbow trout

( Oncorhynchus mykiss ) LC 50 > 0.98 mg ai/L NOAEC = 0.98 mg ai/L

No effects --^ 45499004

Supplemental

Acute

(formulation 9.1% ai) Rainbow trout

( Oncorhnychus mykiss ) LC 50 = 5.68 mg ai/L NOAEC = 0.49 mg ai/L LOAEC = 1.00 mg ai/L

Sublethal effects: hyperventilation, loss of coordination, coughing, darkened pigmentation, reduced opercular
movement Slightly toxic 45638314

Acceptable

Sub-chronic Rainbow trout

( Oncorhynchus mykiss ) 28-day LC 50 > 0.00616 mg ai/L 28-day LOAEC > 0.00616 mg ai/L 28-day NOAEC = 0.00616 mg ai/L

No effects -- 45638216

Supplemental

Sub-chronic

(formulation 9.2% ai) Rainbow trout

( Oncorhynchus mykiss ) 28-day survival LC 50 = 0.657 mg ai/L NOAEC = 0.310 mg ai/L LOAEC = 0.640 mg ai/L

Toxic effects NOAEC = 0.111 mg ai/L LOAEC = 0.310 mg ai/L

28-day wet weight and length NOAEC = 0.640 mg ai/L LOAEC = 0.640 mg ai/L

Effects: lethargy, reduced response -- 45638406

Supplemental

### 13 Taxonomic Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

to food, loss of coordination Estuarine/marine fish Acute Sheepshead minnow

( Cyprinodon variegatus ) LC 50 > 0.002 mg ai/L NOAEC = 0.002 mg ai/L

No effects --^ 45638210

Supplemental

Freshwater invertebrates Acute

(formulation 9.1% ai) Waterflea

( Daphnia magna ) EC 50 = 0.39 μg ai/L NOAEC = 0.11 μg ai/L

No sub-lethal effects Very highly toxic 45638413

Acceptable

Chronic Waterflea

( Daphnia magna ) NOAEC = 0.0299 μg ai/L LOAEC = 0.0628 μg ai/L

Based on parental survival, length, and offspring production) -- 46581401

Acceptable

Estuarine/marine invertebrates Acute Eastern oyster

( Crassostrea virginica ) EC 50 = 1.5 μg ai/L NOAEC = 0.28 μg ai/L

No sub-lethal effects Very highly toxic 45638208

Acceptable

Acute Mysid shrimp

( Americamysis bahia ) LC 50 = 0.13 μg ai/L NOAEC = 0.087 μg ai/L

Sub-lethal effects: lethargy, erratic swimming Very highly toxic 45638209

Acceptable

Chronic Mysid shrimp

( Americamysis bahia ) Survival (28 days) LC 50 = 0.103 μg ai/L NOAEC = 0.06 μg ai/L

Reproduction (number of young/female/day) LOAEC > 0.12 μg ai/L NOAEC = 0.12 μg ai/L

Male Length -- 45638212

Supplemental

### 14 Taxonomic Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

LOAEC = 0.06 μg ai/L NOAEC = 0.026 μg ai/L

Female Length LOAEC > 0.12 μg ai/L NOAEC = 0.12 μg ai/L

Male and Female Dry Weight LOAEC > 0.12 μg ai/L NOAEC = 0.12 μg ai/L Benthic invertebrates Sub-acute Midge

( Chironomus tentans ) Sediment Concentrations: 28-day LC 50 = 24
μ g ai/kg 28-day EC 50 = 34
μ g ai/kg 28-day NOAEC = 15 μ g ai/kg 28-day LOAEC = 30 μ g ai/kg

Pore Water Concentrations: 28-day LC 50 = 0.21 μ g ai/L 28-day EC 50 = 0.30 μ g ai/L 28-day NOAEC = 0.13 μ g ai/L 28-day LOAEC = 0.26 μ g ai/L

Most sensitive endpoints: survival and emergence ratio -- 47621902

Supplemental

Benthic invertebrates Aquatic plants and algae Sub-acute Midge

( Chironomus tentans ) Mean-measured sediment concentrations:

Survival: EC 50 >20 μg ai/kg 95% C.I.: N/A NOAEC = 9.2 μg ai/kg Very highly toxic 48690101

Supplemental

### 15 Taxonomic Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

LOAEC = 20 μg ai/kg

Growth (AFDW): EC 50 = 13 μg ai/kg 95% C.I. = 12 to 14 μg /kg NOAEC = 4.7 μg ai/kg LOAEC = 9.2 μg ai/kg

Mean-measured pore water concentrations:

Survival: EC 50 >2.29 μg ai/L 95% C.I.: N/A NOAEC = 1.38 μg ai/L LOAEC = 2.29 μg ai/L

Growth (AFDW): EC 50 = 1.7 μg ai/L 95% C.I.: 1.6 to 1.8 μg /kg NOAEC = 0.574 μg ai/L LOAEC = 1.38 μg ai/LNonvascular Green algae

( Pseudokircherniella subcapitata ) Cell Density, Growth Rate, and Biomass EC 50 > 9.68 mg ai/L

NOAEC = 9.68 mg ai/L

No effects -- 45638221

Supplemental

Aquatic plants Vascular Duckweed

( Lemna gibba ) Number of fronds and plant biomass EC 50 > 0.075 mg ai/L

NOAEC = 0.075 mg ai/L -- 45638223

Acceptable

### 16 Taxonomic Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

No effects --^Toxicity classification not given based on no effects seen for only one concentration tested and a non-definitive endpoint. -- Toxicity classification not applicable

1 Freshwater fish are surrogates for aquatic-phase amphibians.



## b. Effects to Terrestrial Organisms

Table 6.2. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for Novaluron
Taxonomic

Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

Birds Acute oral Zebra finch

( Taeniopygia guttata ) LD 50 > 2250 mg ai/kg-bw NOAEC = 2250 mg ai/kg-bw

No effects Practically nontoxic 48690102

Acceptable

Acute oral Bobwhite quail

( Colinus virginianus ) LD 50 > 2000 mg ai/kg-bw NOAEC = 2000 mg ai/kg-bw

No effects Practically nontoxic 45476801

Acceptable

Acute oral Mallard duck

( Anas platyrhynchos) LD 50 > 2000 mg ai/kg-bw NOAEC = 2000 mg ai/kg-bw

No effects Practically nontoxic 45499001

Supplemental

Acute dietary Bobwhite quail

( Colinus virginianus ) LC 50 > 5200 mg ai/kg-diet NOAEC = 2610 mg ai/kg-diet

NOAEC based on mortality; no other effects. Practically nontoxic 45499002

Acceptable

Acute dietary Mallard duck

( Anas platyrhynchos) LC 50 > 5310 mg ai/kg-diet NOAEC = 5310 mg ai/kg-diet

No effects Practically nontoxic 45499003

Acceptable

### 17 Taxonomic

Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

Chronic reproduction Bobwhite quail

( Colinus virginianus ) NOAEC = 301 mg ai/kgdietLOAEC = 1013 mg ai/kgdiet

Based on reductions in number of eggs laid and set, viable embryos, live embryos, number of hatchlings, and hatching survival -- 45638218

Acceptable

Chronic reproduction Mallard duck

( Anas platyrhynchos) NOAEC = 9.8 mg ai/kgdietLOAEC = 30 mg ai/kgdiet

Based on reductions in number of viable embryos, ratio of viable embryos to eggs set, and live embryos -- 45638219

Acceptable

Mammals Acute oral Laboratory rat

(Rattus norvegicus) LD 50 > 5000 mg ai/kg-bw

No effects Practically nontoxic 44961001

Acceptable

Chronic Reproduction Laboratory rat

(Rattus norvegicus) NOAEC = 1000 mg ai/kg-dietLOAEC = 4000 mg ai/kgdiet

Based on decreased sperm counts in male F 1 generation -- 45651505

Acceptable

Terrestrial insects Acute
contact Honeybee

( Apis mellifera ) LD 50 > 100 μg ai/bee NOAEC = 100 μg ai/bee

No effects Practically nontoxic 45638220

Acceptable

Acute oral Honeybee

( Apis mellifera ) LD 50 > 100 μg ai/bee NOAEC = 100 μg ai/bee

No effects Practically nontoxic 45638220

Supplemental

Acute oral (formulation 9.1% ai) Honeybee

( Apis mellifera ) LD 50 > 200 μg ai/bee NOAEC = 200 μg ai/bee

No effects Practically nontoxic 45638408

Acceptable

### 18 Taxonomic

Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

Field-testing for pollinators Honeybee

( Apis mellifera ) LC 50 = Not determined

Adverse effects observed on brood development in egg, young, and old larval stages in the 3.3 ml formulation/L treatment
group. -- 45638407

Supplemental

Field-testing for pollinators Honeybee

( Apis mellifera ) LC 50 = Not determined

Adverse effects observed on brood development in egg, young, and old larval stages in the 225 g ai/ha treatment group. -- 45638409

Supplemental

Terrestrial invertebrates Sub-chronic Earthworm

( Eisenia foetida ) LC 50 > 1000 mg ai/kg-soil NOAEC = 1000 mg ai/kg-soil

No effects -- 45638224

Supplemental

Terrestrial plants Vegetative vigor Monocot Onion ( Allium
cep a), corn ( Zea
mays ), ryegrass ( Lolium perenne ), wheat ( Triticum aestivum )

Dicot Oilseed rape ( Brassica napus ), cabbage ( Brassica oleracea ), soybean ( Glycine max ), lettuce ( Lactuca sativa ), tomato ( Lycopersicum esculentum ), bean ( Phaseolus vulgaris ) Monocot (all) EC 25 > 0.896 lb ai/A NOAEC = 0.896 lb ai/A

Dicot (bean) EC 25 > 0.896 lb ai/A NOAEC < 0.896 lb ai/A

Based on 14% reduction in dry weight of bean. Phytotoxic effects in all species included chlorosis, necrosis, leaf wilt -- 48690103

Acceptable

### 19 Taxonomic

Group Study Type Surrogate Species Toxicity Value Acute Toxicity Classification Source and Classification

Seedling
emergence Monocot Onion ( Allium
cep a), corn ( Zea
mays ), ryegrass ( Lolium perenne ), wheat ( Triticum aestivum )

Dicot Oilseed rape ( Brassica napus ), cabbage ( Brassica oleracea ), soybean ( Glycine max ), lettuce ( Lactuca sativa ), tomato ( Lycopersicum esculentum ), bean ( Phaseolus vulgaris ) Monocot (all) EC 25 > 0.972 lb ai/A NOAEC = 0.972 lb ai/A

Dicot (bean) EC 25 > 0.972 lb ai/A NOAEC < 0.972 lb ai/A

Based on reduction in dry weight of bean. Phytotoxic effects in all species included chlorosis, necrosis, leaf wilt -- 48690104

Under Review*

*This study is still under review. Results suggest a non-defi nitive (less than) NOAEC for di cots (bean) tested at the application rate of 0.972 lb ai/A.



## c. Degradates

Table 6.3 provides aquatic taxa toxicity informat ion for one major degradate of novaluron: chlorophenyl urea. Toxicity data are not avai lable for the other major degradate of concern, chloroaniline. The degradate 2,6-difluorobenzoic acid is consid ered minor and will not be considered further because it has lost the chloro analine toxic moiety and much less toxic than novaluron and its major degradates. Given the similarity in chemical structure between chloroaniline and chlorophenyl urea, it is assumed that the former will be more similar in its toxicity to chlorophenyl urea than to the parent, novaluron. ECOSAR methods wi ll be used to predict aquatic toxicity for the degradates, when data are not available, based on their structural similarity to chemicals for which aquatic toxic ity data are known (ECOSA R predictive software is available publically th ough the Epi SuiteTM program 2 

### ). While no toxicity data exist for chloroaniline, toxicity data for the degradate chlorophenyl urea suggest it is more toxic to freshwater fish, and algae than novaluron. Sub-chronic studies on earthworms suggest the chlorophenyl urea is more toxic to terrestrial invertebra tes (earthworms) than parent novaluron. The toxicity of these degradates has previously been assumed to be equal and was previously modeled separately from the parent in a residu e summation of total toxic residues (TTR) for both degradates. Since degradate data indicates chlorp henyl urea may be more toxic to some aquatic organisms than the parent novalu ron, moving forward the toxic e quivalency (TEQ) approach will be used assess the parent (novaluron) and degradat es (chlorphenyl urea and chloroaniline). An

1 http://www.epa.gov/oppt/exposure/pubs/episuite.htm

### 20 RQ calculated using the TEQ approach represen ts risk from combined exposure to parent novaluron and degradates chlorp henyl urea and chloroaniline.

Table 6.3. Summary of the Most Sensitive Endpo ints from Aquatic Toxicity Studies for Novaluron Degradate Chlorphenyl Urea
Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in terms of the degradate) Acute Toxicity Classification Source and Classification

Freshwater invertebrates Acute

Metabolite chlorophenyl urea 275- 352 I (96.2%) Waterflea

( Daphnia magna ) EC 50 = 1910 μg ai/L NOAEC = 690 μg ai/L

No sub-lethal effects Moderately toxic 45499007

Supplemental

Freshwater fish Acute

Metabolite chlorophenyl urea 275- 352 I (96.2%) Rainbow trout

( Oncorhynchus mykiss ) LC 50 = 0.530 mg ai/L NOAEC (sub-lethal effects) = 0.144 mg ai/L

Sub-lethal effects: darkened eye orbits, hyperventilation, loss of coordination, nervous behavior, lethargy, darkened Highly toxic 45499006

Acceptable

Aquatic plants and algae Metabolite chlorophenyl urea 275- 352 I (96.2%) Non-vascular plant Green algae

( Pseudokircherniella subcapitata ) Cell Density EC 50 = 0.33 mg ai/L NOAEC = 0.105 mg ai/L

Growth Rate EC 50 > 0.890 mg ai/L NOAEC = 0.105 mg ai/L

Biomass EC 50 = 0.32 mg ai/L NOAEC = 0.105 mg ai/L -- 45638222

Supplemental

Terrestrial invertebrates Sub-chronic chlorophenyl urea (99.3%) Earthworm

( Eisenia foetida ) LC50 = 447 mg ai/kg-soilNOAEC = 171 mg ai/kgsoilLOAEC = 309 mg ai/kgsoil

Mortality and reduction in body weight -- 45638225

Supplemental



### ECOSAR run estimates for chlorphenyl urea and chlo raniline are presented in table 6.4 below. To verify the reliability of the ECOSAR predictions, 

### the results are compared to known novaluron and chlorphenyl urea toxicity endpoints. As prev iously mentioned, no toxici ty data are available for chloroaniline so only the ECOSAR estimate is included. The results suggest that ECOSAR generally under-estimates toxicity. Consequently, degradate data are necessary to properly evaluate the risks of this chemical.

### 21 Table 6.4. ECOSAR Estimates for Chlorphenyl U rea and Chloraniline compared to known toxicity endpoints

Toxicity Novaluron (effects studies) Novaluron (ECOSAR

estimate) Chlorophenyl urea (effects studies) Chlorophenyl urea (ECOSAR estimate) Chloroaniline (ECOSAR estimate)
Concentration ( μ

g ai/L)

Acute freshwater fish LC 50 > 960 LC 50 = 919 LC 50 = 530 LC 50 = 14355 LC 50 = 4790

Acute freshwater invertebrate LC 50 = 4.31 LC 50 = 9.0 LC 50 = 1910 LC 50 = 4021 LC 50 = 2146

Non-vascular aquatic plant EC 50 > 9680 EC 50 = 37.0 EC 50 = 320 EC 50 = 184 EC 50 = 1649



## d. Ecological Incidents

The ecological incident information system (EIIS ) is an Office of Pesticide Programs database that houses ecological incidents that have been reported to the Agency. When available, EIIS includes the date and location of an incident, ty pe and magnitude of effects observed in various species, use(s) of pesticides known or suspected of contributing to the incident, and results of any chemical residue analysis or other analyses conducted during incident investigation. EIIS incidents are categorized according to the certaint y that the incident resulted from pesticide exposure. The Avian Incident Monitoring System (AIMS) is a database administered by the American Bird Conservancy that contains publi cly available data on reported avian incidents involving pesticides. Incident s listed in this database may also be in the EIIS.

Searches of the Ecological Incident Information System (EIIS v. 2.1.1), Avian Incident Monitoring System (AIMS), and the aggregate Inci dent Data System were performed on 12/4/14. No ecological incidents were reported in any of the databases for novaluron or its degradates. Although incident reporting is requi red under FIFRA Section 6(a)(2), the absence of reports in EIIS does not indicate that the chemical has no effects on wildlife; rather, it is possible that incidents have gone unreported.



# 7. Exposure Pathways of Concern

The environmental fate properties and use patterns of novaluron indicate that direct spray, spray drift, leaching to ground water, and runoff represent potential tran sport mechanisms to aquatic and terrestrial organisms. Dri nking water and inhalation exposure pathways were screened using the SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods and were found to be exposure pathwa ys of low concern (no LOC exceedances are expected) (Appendix 5) . SIP and STIR are de scribed in detail at: http://www.epa.gov/oppefed1/m odels/terrestrial/index.htm.

### 22 

# 8. Analysis Plan

a. Stressors of Concern
i. Ecological Risk Assessment The stressors of ecological concern for terrestr ial organisms are novaluron and its degradates. Novaluron regulates insect growth by interf ering with the molting process. Consequently, endpoints based on effects to adults or non-molting j uveniles do not accurately reflect the toxicity of the compound for molting organisms. Toxicity e ndpoints derived from chronic studies will be used to more appropriately assess the risks of this type of chemical because the endpoints capture a molting stage; critical to evaluating effects of an insect growth regulator. No observed adverse effects concentrations (NOAECs) fr om the chronic guideline tests wi ll be used to evaluate both acute and chronic risk for terrestria l invertebrates. Acute toxicity da ta will still be used to assess acute risk concerns for birds and mammals. Wh ile adult honeybees have not displayed much sensitivity to novaluron, larval studies are not available and will be nece ssary to proceed with assessing risk to bees. Additionally, terrestrial invertebrates (earthworms) have also displayed a greater sensitivity to the degradate chlo rophenyl urea than th e parent novaluron.

The stressors of concern for aquatic organi sms are novaluron and its major degradates chlorophenyl urea and chloroaniline. As with the terrestrial assessment, endpoints based on effects to adults or non-molting juveniles do no t accurately reflect the toxicity of the compound for molting organisms. Toxicity endpoints derived from chronic studies, in addition to acute studies, will be used to more appr opriately assess the risks of this type of chemical because they endpoints capture a molting stage; cri tical to evaluating effects of an insect growth regulator. No observed adverse effects concentr ations (NOAECs) from the chroni c guideline tests will be used with acute endpoints to assess risk for aquatic invertebrates. Risk concerns for aquatic fish and aquatic plants will be also assessed with acute and chronic endpoints. In addition, available toxicity data shows that aquatic plants, freshwat er invertebrates and fres hwater fish have some sensitivity to the degradate chlo rophenyl urea. No data are av ailable for chloroaniline. Both degradates will be considered stressors of concern for the risk assessment of aquatic organisms ( i.e. aquatic plants, aquatic invert ebrates, and fish) and modele d using the toxic equivalency (TEQ) approach to assess both the parent and degradates when data are available. For chloroaniline, without toxicity da ta ECOSAR estimates of toxicity endpoints will be used in this approach.

ii. Drinking Water

If a new drinking water assessment is needed, it will include the parent novaluron and degradates chlorophenyl urea (275-352I) and chloroaniline (275-309I) based on the MARC memorandum of the HED (USEPA 2004c, D278044). The assessment will be performed based on EFED’s current guidance using appropriate surf ace and groundwater models. Desc riptions of all executable versions of current models for drinking wa ter exposure can be obtained from URL link: http://www.epa.gov/oppef ed1/models/water/.

### 23 

## b. Measures of Exposure

EFED will use the latest standard available models to evaluate potential exposures to aquatic and terrestrial organisms as described at http: //www.epa.gov/pesticides/science/models_db.htm. The parent novaluron only will be asse ssed for terrestrial exposures i ndependently and where data are available a TEQ approach will be used for the parent and degradates chlorophenyl urea (275- 352I)/chloroaniline (275-309I) for aquatic exposures.

i. Available Monitoring Data

The Agency is aware of monitoring conducted by federal and state agencies such as U.S. Geological Survey (USGS) National Water Qu ality Assessment (NAWQA) Data Warehouse and California Environmental Data Exchange Networ k (CEDEN). This exposure data will be considered in the assessment to the extent th at data on novaluron and/ or its degradates are available.



## c. Measures of Effect

Toxicity data presented in Section 6 of this pr oblem formulation will be used to calculate risk quotients. Any additional information submitted by th e registrant or found in the open literature prior to conducting the risk assessment will also be considered. The open literature studies are identified using EPA’s ECOTOXicology database (ECOTOX), which employs a literature search engine for locating chemical toxic ity 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 speci es that are sensitive to the chemicals and from changes in structure and functional charac teristics of the affected communities.



# 9. Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally listed, thr eatened, and/or endangered (listed) species from registered uses of pesticides in registration re view. The process for evaluating potential risks to listed species is further described at http://www.epa.gov/oppfead1/enda nger/litstatus/riskasses.htm

.



# 10. Endocrine Disrupto r Screening Program

Novaluron was not included in the first gr oup of 67 chemicals nor the second group of 109 chemicals that will or have been issued an or der to conduct Tier 1 Endocrine Disruptor Screening Program (EDSP) testing. For additi onal information the EDSP program, visit http://www.epa.gov/endo/.

### 24 

# 11. Preliminary Identification of Data Gaps

a. Environmental Fate
Table 11.1 identifies environmental fate studies by MRID that offer data for each guideline requirement, as well as study classi fications and whether or not furt her data are needed to support the risk assessment. There are no environmental fa te studies available for either major degradates of novaluron ( i.e. , chlorophenyl urea and chlo roaniline). Since EFED is using the TEQ approach to assess risk to aquatic organisms ( i.e. , plants, fish and aquatic inve rtebrates) in the Registration Review ecological risk assessment, environmental fate input parameter data for chlorophenyl urea and chloroaniline would facilitate the modeling of EECs. In the absence of data, EFED will assume these degradates are stable and use QS AR modeling (EPISuite ver. 4.0) to estimate the physical and chemical properties needed for mode ling inputs. Additional environmental fate and physicochemical properties of major degradates can reduce the uncerta inties in the aquatic exposure assessment.

Table 11.1. Submitted Environmental Fate Data for Novaluron

OCSPP Guideline Data Requirement Source MRID Classification Are data needed to conduct

risk assessment? Justification and A ssumptions EPA Will Make in the Absence of Data

835.2120 Hydrolysis 4496 1008 Acceptable No ---
835.2240 Aqueous Photolysis 45638203 Supplemental No ---

835.2410 Soil Photolysis 4 5638204 Acceptable No ---

835.4100 Aerobic Soil Metabolism 44961009 44961010 Acceptable Supplemental No ---

835.4200 Anaerobic Soil Metabolism 45638205 Supplemental No ---

835.4300 Aerobic Aquatic Metabolism 45638206 Supplemental No

---

835.4400 Anaerobic Aquatic Metabolism 45638207 45789203 Partially Acceptable 1 No ---

835.1230 835.1240 Adsorption/ Desorption and Leaching 44961011 44961012 45638201 45638202 Supplemental No ---

835.6100 164-1 Terrestrial Field Dissipation 45638403 45638404 45789204 Supplemental Acceptable Acceptable No ---

850.6100 ECM/ILV (soil and water) --- --- Yes ECM/ILV (soil and water) for parent and metabolites: chlorophenyl urea (275-352I) and chloroaniline (275-309I)

### 25 OCSPP Guideline Data Requirement Source MRID Classification Are data needed to conduct

risk assessment? Justification and A ssumptions EPA Will Make in the Absence of Data

850.1730

165-4 Fish bioconcentration 45638215 45785802 Supplemental No ---

NonGuideline

Study Biological effects on fresh water aquatic ecosystems - microcosm study 45785801 Supplemental No ---

1 The portion of this study, conducted with [chlorophenyl-U- 14C]-labeled novaluron, is classified acceptable



## b. Ecological Effects

Table 11.2 and Table 11.3 identify ecological effects studies by MRID that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed to support risk assessment. Rationale for the ad ditional data requested is presented below the tables. No chronic data are available for estuarine/mari ne fish and the acute estuarine/marine fish toxicity endpoint was non-definiti ve (greater than). Two acute st udies with TGAIs for freshwater fish and one for estuarine/marine fish all pr oduced non-definitive endpoints with no effects. Without a definitive acute toxicity value the chronic toxicity cannot be estimated and it remains unclear if chronic risks are possible for estuarin e/marine fish or which group (freshwater or estuarine/marine fish) is more sensitive to novaluron. A definitive acute toxicity value using TGAI for freshwater fish using the rainbow trout would make it pos sible to calculate a conservative chronic endpoint estimate for estuar ine/marine fish by comparing the freshwater definitive endpoints to the estuarine/marine endpoints. Terrestrial plant toxici ty endpoints used to evaluate risks to listed and non-listed species we re non-definitive for dicots. While both Tier I seedling emergence and vegeta tive vigor tests, yielded LC 50 

### endpoints greater than the highest concentration tested, effects were observed in dicots (statistically significant 14% reduction in dry weight with some signs of phytotoxicity that appeared to be treatment-related 

### ) in both the vegetative vigor, and the seedling emergence (under review at the Agency). Additional data or a study to establish a NOAEC for dicots is requir ed to assess risk to plants.

### 26 Table 11.2. Aquatic Ecological Effects Data for Novaluron and Remaining Data Gaps

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? Justification and Assumptions EPA will

Make in Absence of Data

850.1010 Freshwater invertebrate acute toxicity 45638413 (water flea) Acceptable No No acceptable TGAI 1 studies exist for freshwater invertebrates. A definitive endpoint only exists for MRID 45638314 using a formulation. Chronic toxicity tests whose duration covers a molting stage better characterize the risk from this type of chemical due to the mode of action as in IGR. Acute risks will be evaluated using chronic toxicity endpoints and may be further characterized using the available TEP 2 data.

850.1025 850.1035 Saltwater invertebrate acute toxicity 45638208 (mollusk) Acceptable No --

45638209 (mysid) Acceptable

850.1075 Freshwater fish acute toxicity 45638314 (rainbow trout) Acceptable No No acceptable TGAI 1 studies exist for freshwater fish. A definitive endpoint only exists for a study using the rainbow trout and a formulation (MRID45638314). The nondefinitive endpoints from the two listed studies are greater than the parent solubility limit and will be used to characterize risk based on a comparison with the definitive TEP 2 study endpoint. 45499005 (bluegill sunfish) Supplemental

45499004 (rainbow trout)

850.1075 Saltwater fish acute toxicity 45638210 Supplemental No

850.1300 Freshwater invertebrate life cycle 46581401 (daphnid) Acceptable No

### 27 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? Justification and Assumptions EPA will

Make in Absence of Data
850.1350 Saltwater invertebrates life cycle 45638212 (mysid) Supplemental No The supplemental study is considered scientifically sound for use in the risk
assessment.
850.1400 Freshwater fish early-life stage (None) N/A No There is no 60 day chronic study using TGAI 1 for freshwater fish. Chronic risks to fish will be estimated using a non-guideline 28 day sub-chronic study (MRID 45638216). The 28 day study did not exhibit any effects, and is considered less conservative than the 60 day endpoint.

### 28 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? Justification and Assumptions EPA will

Make in Absence of Data
850.1400 Saltwater fish early-life stage (None) N/A Yes No chronic data are available for estuarine/marine fish. It is uncertain if estuarine/marine fish are more or less sensitive than freshwater fish to novaluron (the estuarine/marine and freshwater fish acutevalues were nondefinitive. In the absence of estuarine marine data, an acute freshwater fish test (TGAI 1 ) with the rainbow trout yielding a definitive endpoint would allow EFED to calculate a conservative chronic endpoint using an acute to chronic ration (ACR). Risks cannot be precluded without an endpoint to characterize risk. 850.1500 Fish life cycle (None) N/A No --

850.1735 Whole sediment – sub-chronic freshwater invertebrates 47621901 (midge) Supplemental No The supplemental study is considered scientifically sound for use in the risk
assessment Non-guideline Whole sediment – chronic freshwater invertebrates 48690102 (midge) Supplemental Yes Current testing for sediments requires additional species. Available data only addresses a single species. A TGAI 1 test with Hyalella azteca for potential differential sensitivity among sediment organisms is required . A protocol should be submitted in advance of conducting the study.

### 29 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? Justification and Assumptions EPA will

Make in Absence of Data
850.1740 Whole sediment – chronic freshwater invertebrates None N/A Yes An estuarine/marine organism is required for sediment testing . A 28 day TGAI 1 test with additional Leptocheirus plumulosus should be performed to evaluate the potential differential sensitivity among sediment organisms. A protocol should be submitted in advance of conducting the study. 850.4400 Aquatic vascular plant toxicity test using Lemna spp. 45638223 Acceptable No --

850.4500 Non-vascular plant toxicity 45638221 (green algae) Supplemental Ye s Three species, a freshwater algae, freshwater diatom, and estuarine/marine diatom are required. Only data for green algae are available. Data to evaluate the relative sensitivities of vascular plant species are required for risk assessment. 850.4550 Non-vascular plant toxicity Cyanobacteria Freshwater diatom Estuarine/marine diatom N/A Yes

1 TGAI = technical grade active ingredient

2 TEP = typical end-use product



### Table 11.3 Terrestrial Ecological Effects Data for Novaluron and Remaining Data Gaps

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Justification and Assumptions EPA will Make in Absence of Data

850.2100 Avian oral toxicity 45476801 (bobwhite) Acceptable No --

45499001 (mallard) Supplemental

48690102 (zebra finch) Acceptable

850.2200 Avian dietary toxicity 45499002 (bobwhite) Acceptable No --

### 30 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Justification and Assumptions EPA will Make in Absence of Data

45499003 (mallard) Acceptable

850.2300 Avian reproduction 45638218 (bobwhite) Acceptable No --

45638219 (mallard) Acceptable

Non-guideline Avian inhalation (None) N/A No --

850.3020 Honeybee adult acute
contact toxicity 45638220 Acceptable No --

Non-guideline (OECD 213) Honeybee adult acute oral toxicity 45638220 Supplemental No The supplemental study is considered scientifically sound for use in the risk
assessment Non-guideline 4 Honeybee adult chronic toxicity (including
acute endpoints) (none) N/A No Due to the mode of action affecting molting juvenile insects, adults are not expected to be sensitive to novaluron.

Non-guideline 4 Honeybee larval chronic toxicity (including
acute endpoints) (none) N/A Yes A chronic larval test should be performed with novaluron (TGAI 1 ). In the absence of data, risks will be presumed to larval honeybees based on the expected increased toxicity to larvae versus adults. Non-guideline Residues in pollen and
nectar (none) N/A Yes Additional studies may be necessary if risk concerns are identified for juvenile bees at the tier I level. Pollen/nectar residue data may be required to refine the risk assessment to bees. A protocol should be submitted in advance of conducting the study

. 850.3040 45638407 Supplemental Yes

### 31 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Justification and Assumptions EPA will Make in Absence of Data

Field testing for pollinators 45638409 Supplemental Additional semi-field or field studies may be necessary if risk concerns are identified for juvenile bees at the tier I level. Pollen/nectar residue data may be required to refine the risk assessment to bees. A protocol should be submitted in advance of conducting the study. 850.4100 Seedling Emergence and Seedling Growth 48690103 Under review 1 Yes This study is under review and a final determination has not been made.Results indicate a nondefinitive NOAEC for dicots (bean). Without a definitive NOAEC risks for listed plants cannot be precluded. 850.4150 Vegetative Vigor 48690103 Acceptable Yes A NOAEC was not established for dicots (bean). Without a definitive NOAEC risks for listed plants cannot be precluded.

1 TGAI = technical grade active ingredient

2 TEP = typical end-use product

3 The study is currently under review and a final determination has not yet been made.



### Effects data and data gaps for the degradates are listed below in table 11.4. Since some chlorphenyl urea data indi cate the degradate is more toxic than the parent to some aquatic taxa, aquatic guideline studies are requested below. Toxicity data are not available for the chloroaniline degradate; however, given the similarity in chemical structure between chloroaniline and chlorophenyl urea, it is assumed that the former will be more similar in its toxicity to chlorophenyl urea than to the parent, novaluron. Se lect studies are requested for this degradate (chloroaniline) to help establish if e qual toxicity can be assumed, or if chloroaniline may actually be more toxic than the chlorophenyl urea. Additional data may be required pending results of the requested data ba sed on the toxicity results.

### 32 Table 11.4. Ecological Effects Data for Degrad ates Chlorphenyl Urea/Chloroaniline and Remaining Data Gaps

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct

risk assessment? Justification and Assumptions EPA will Make in Absence of Data - Some Example texts are include

850.1010 Freshwater invertebrate acute toxicity 45638413 (Chlorphenyl urea) Supplemental No Comparisons to the parent study will be characterized based on the available data. The degradate study was done with a TGAI 1 while the acceptable parent study is with a formulation (TEP 2 ).

850.1025 850.1035 850.1045 850.1055 Saltwater invertebrate acute toxicity None (N/A) Yes No data are available for the chloroaniline or chlorphenyl urea. A study is requested to establish the toxicity of chlorphenyl urea to invertebrates, a group sensitive to the parent.

850.1075 Freshwater fish acute toxicity 45499006 (Chlorophenyl urea) Acceptable Yes No data are available for the chloroaniline degradate. The chloroaniline degradate is expected to be equivalent or more toxic than the chlorophenyl urea degradate, based on similarity in chemical structure . A study with the chloroaniline degradate would reduce the uncertainty surrounding the ac tual toxicity of this degradate.

850.1075 Saltwater fish acute toxicity None (N/A) No Additional data is not requested at this time but may be requested at a later date pending results of the requested toxicity studies.

850.1300 Freshwater invertebrate life cycle None (N/A) Yes Given that aquatic invertebrates are a group sensitive to the parent novaluron a toxicity study for both degradates would establish a reference point between novaluron and its degradates for this stage

.

### 33 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct

risk assessment? Justification and Assumptions EPA will Make in Absence of Data - Some Example texts are include

850.1350 Saltwater invertebrates life cycle None (N/A) Yes Given that aquatic invertebrates are a group sensitive to the parent novaluron, a toxicity study for chlorophenyl urea would reduce uncertainty of the actual degradate toxicity to estuarine/marine invertebrates.

850.1400 Freshwater fish early-life stage None (N/A) Yes Chlorphenyl urea was considered very highly toxic to the rainbow trout on an acute basis. A chronic study with chlorophenyl urea would reduce uncertainty and make comparisons to see if these fish are more sensitive to the degradate than the parent on a chronic basis

. 850.1400 Saltwater fish early-life stage None (N/A) No Additional data is not requested at this time but may be requested at a later date pending results of the requested toxicity studies. 850.1500 Fish life cycle None (N/A) No Additional data is not requested at this time but may be requested at a later date pending results of the requested toxicity studies. 850.4400 Aquatic plant Toxicity Test using Lemna
spp. None (N/A) Yes No toxicity data on the degradates are available for aquatic vascularplants. Because aquatic nonvascular plants were more sensitive to chlorphenyl urea than the parent novaluron additional data with chlorophenyl urea for vascular plants would help clear up uncertainty regarding the toxicity of this degradate to these plants.

### 34 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct

risk assessment? Justification and Assumptions EPA will Make in Absence of Data - Some Example texts are include

850.4500 Algal toxicity 45638222 (Chlorphenyl urea) Supplemental (algae) Yes No data are available for any additional species or the chloroaniline degradate. The chloroaniline degradate is expected to be equivalent or more toxic than the chlorophenyl urea degradate, based on similarity in chemical structure. Chlorphenyl urea data indicate that it is more toxic to green algae than novaluron. A green algal study with chloroaniline and another species of freshwater or saltwater diatom on chlorphenyl urea would establish the comparison of relative sensitives of this taxa. 850.4550 Cyanobacteria None (N/A) No Additional data is not requested at this time but may be requested at a later date pending results of the requested toxicity studies.

1 TGAI = technical grade active ingredient

2 TEP = typical end-use product



### Additional justification for non-guideline data requests:

Study Title: Tier 1- Larval Hone ybee Acute and Chronic Oral Exposure Rationale for Requiring the Data Developing bee brood (i.e., larvae and pupae) can be exposed to pesticides through residues brought back to the colony by worker bees fora ging in areas where th e pesticide has been applied. While larvae are typically fed roya l or brood jelly during th eir early stages of development, worker bee (females) and drone (males) larvae are also fed pollen/honey (bee bread) directly by in-hive nurse bees. EPA guidance (USEPA 2014c) on assessing the risk of pesticides to bees identifies a suite of laboratory-based studies intended that serve as the foundation for screening chemical for potential ac ute and chronic effects to larval bees. Practical Utility of the Data How will the data be used? The 21-day larval toxicity study 1 

### under development by OECD provides both acute and chronic toxicity data on devel oping bee brood and will yield a me dian lethal dose (LD50) for assessing acute toxicity during the early part of the study as well as a 21-day no-observed adverse effect level (NOAEL) and lowest- observed adverse effect level (LOAEL) for assessing chronic effects. Alternatively, regist rants may submit a separate acute (single dose) larval toxicity study following OECD Guideline 237 2 

### as well as the 21-day repeat dose chronic toxicity study to address both acute and chronic larval endpoints. Effects on survival

### 35 and development (adult bee emergence) from rep eat exposures to the active ingredient will be used in estimating chronic risk to individual brood. A protocol for the 21-day larval toxicity test should be submitted to the Agency for review before commencing the study and should include provisions for measuring the concentrat ion of novaluron in the actual diet of the honeybee.

How could the data impact the Agency’s future decision-making? Effects on survival and development from repeat exposures to the active ingredient will be used in estimating acute and chronic risk to individual brood. Risk estimates based on these data will be considered along with other line s of evidence to determ ine whether higher-tier studies are needed at the whole colony level.

[1] Draft guidance for the 21-day larval toxicity study is available
at: http://www.oecd.org/env/ehs/te sting/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf [2] OECD Guideline 237 is available at: http://www.oecdilibrary.org/docserver/download/9713171e .pdf?expires=1407449911&id=id&accname=guest &checksum=E67BEDEB01DB12D815E858CB45A 989FB



### Study Title: Tier II Semi-Field Testing with Honeybee Colonies Rationale for Requiring the Data Bees can be exposed to pesticides through multip le pathways including contact with sprays and dusts and through ingestion of residues in fo od/water (e.g., pollen/nectar and water used to maintain colony temperature). Worker bees foraging on flowers for pollen and nectar can be exposed to residues in pollen and nectar either through direct contamination of these matrices by foliar sprays and/or dusts. Residues can in turn be brought back to bee colonies where in-hive bees including young adult and de veloping brood (i.e., eggs, larvae and pupae) may be exposed. EPA guidance on assessing the risk of pesticides to bees identifies a tiered process where the initial screen is based on a suite of acute and chr onic laboratory studies individual adult bees and larvae. If screen ing-level assessment indi cates potential chronic risks to individual bees, then higher-tier, semi-field testi ng studies may be required to examine potential effects at the colony level. Novaluron is an insect growth regulator that is applied to a variety of crops that rely on insect pollination. Residues on these crops can provide a route of exposure to foraging pollinators. Practical Utility of the Data How will the data be used? If acute tests with larval bees indicate that the novaluron is toxi c to juvenile bees on an acute contact exposure basis and further effects are obs erved in chronic tests to individual bees, or acute and chronic test on honeybee larva, tier II studies such as the semi-field tests are needed (and may be requested) to determine whet her whole colonies can be affected.

If tests indicate that novaluron is toxic to juvenile bees on an acute or chronic exposure basis and further effects are observed in chronic tests to i ndividual bees, or ac ute and chronic test on honeybee larva, tier II studies such as the se mi-field tests may be needed to determine whether whole colonies can be affected. Pollen/n ectar residue data may be required to refine the risk assessment to bees

### 36 How could the data impact the Agency’s future decision-making? Risk estimates based on these data will be cons idered along with other lines of evidence to determine whether higher-tier studi es are needed at the whole-co lony level to more precisely characterize the effects of real-world application.

Study Title: Whole sediment: Chronic invert ebrates freshwater invertebrates – TGAI wit h Hyalella azteca Rationale for Requiring the Data Chronic sediment toxicity tests for the freshwater inve rtebrate midge ( Chironomus riparius and Chironomus tentans ) have been submitted to satisfy the Agency’s updated data requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007); however, an additional epibenthic species is required. Based on the cu rrent use patterns, benthic organisms may be exposed to run-off or spray drift from novalur on uses. Novaluron, an in sect growth regulator which can be persistent, affects molting inverteb rates, and available studies with the infaunal midge indicate it is highly toxi c to benthic invertebrates. An additional chronic sediment test encompassing a molting period is reque sted on a freshwater amphipod (e.g., Hyalella azteca ) to establish sensitivity differences between the two species. Both freshwater species, Hyalella and Chironomus differ substantially in their ecological niche (i.e., epibenthic vs. infaunal species), life hist ory and phylogeny.

Practical Utility of the Data How will the data be used? Data from sediment toxicity studies will be used to estimate potential risks to benthic organisms associated with uses of novaluron. Th e data will reduce uncer tainties associated with the current risk assessmen t for benthic species and will improve our understanding of the potential effects of novalu ron on aquatic ecosystems.

How could the data impact the Agency’s future decision-making? Available data indicates that registered novalu ron uses pose a risk ofadverse effects to nontarget benthic organisms above the Agency Leve l of Concern. With data for the additional species, the Agency may explore other decision opti ons to mitigate this risk. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in use restrictions for novaluron which may otherwise be avoided, or whic h are unnecessarily severe.



# 12. References

FAO. 2000. Appendix 2. Parameters of pesticides that influence processe s in the soil. In FAO Information Division Editorial Group (Ed.), Pesticide Disposal Series 8. Assessing Soil Contamination. A Reference Manual. Rome: Food & Agriculture Organization of the United Nations (FAO). Available at http://www.fao.org/DOCREP/003/X2570E/X2570E06.htm (Accessed Nov 14, 2014).

### 37 USEPA. 2004a. Novaluron Estimated Drinking Water Concentration for Use in the Human Health Drinking Water Risk Assessment. D285477 and D285479. 20pp.

USEPA. 2004b. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs. Office of Prevention, Pesticides, and Toxic Substances. Office of Pesticide Programs. Washington, D.C. January 23, 2004.



### USEPA. 2004c. Novaluron. Report of the Me tabolism Assessment Review Committee (MARC). D297646. 44pp.

USEPA. 2007. Novaluron and Novaluron Degrad ates (Chlorophenyl urea and Chloroaniline) Drinking Water Assessment in Support of New Use Registration Action for Tomato, Sugarcane, and Increase in Applicatio n Rate to Brassica. D345672, D340579, D340581, and D340583. 3pp.

USEPA. 2009a. Novaluron and Novaluron Degrad ates (Chlorophenyl urea and Chloroaniline) Drinking Water Assessment in Support of Ne w Use Registration Action for Stone Fruit, Bushberries, Brassica Leafy Greens, and Turnip Greens. D357061. 17pp.

USEPA. 2009. Novaluron and Novaluron Degrad ates (Chlorophenyl urea and Chloroaniline) Drinking Water Assessment in Support of New Use Registration Action for Sorghum, Fruiting Vegetables (Group 8, D364309), Cucu rbit Vegetables (Group 9), Low-growing Berry Subgroup (13-07G), Snap and Dry Bean, and Swiss Chard. D363989 and D364309. 4pp.

USEPA. 2010. Tier II Dri nking Water Exposure Assessment for Novaluron and Novaluron Degradates (Chlorophenyl urea and Chloro aniline) in Support of the New Use Registration on Sweet Corn. D378389. 17pp.

USEPA. 2011. Tier II Dri nking Water Exposure Assessment for Novaluron and Novaluron Degradates Chlorophenyl Urea and Chloroani line to Control Germ an, Asian, and Brown Banded Cockroaches and Crickets in Resident ial Areas and Control Mosquito Larvae in Small Water Bodies. D387737, D387738 and sub-bean D388519 (parent bean D385667). 3pp.

USEPA. 2012. Drinking Water Assessment in S upport of the New Use of Novaluron in Peanuts and Soybeans. D402324. 23pp.

USEPA. 2013a. Drinking Water Assessment in Support of the New Indoor and Outdoor nonfood Use of Novaluron for Pest Control. D412441. 28pp.

USEPA. 2013b. Ecological Risk Assessment for the Proposed New Uses of Novaluron on Indoor and Outdoor Control of Fleas, Roaches , Litter Beetles, Ants , and Flying Insect Pests; and Flies, Beetles, and Other Insect Pests in Cattle, Poultry, and Horse Operations. Environmental Fate and Eff ects Division, Office of Pesticide Programs, United States Environmental Protection Agency.

### 38 USEPA. 2014a. Novaluron screening level usag e analysis. Biological and Economic Analysis Division, Office of Pesticide Programs, Unite d States Environmental Protection Agency.

USEPA. 2014b. Drinking Water Assessment in Support of IR-4 New and Revised Uses of Novaluron (RIMON ® 

### 0.83 EC) on Avocado; Beans, Berries (Low-Growing), Bushberries, Carrot; Cotton, Cucurbit Vegeta bles, Fruiting Vegetables, Head and Stem Brassica, Leafy Brassica Greens, Orname ntals (Container Grown Ornamentals in Greenhouses, Shadehouses, Outdoor Nurseries), P eanuts, Pears, Pome Fruits, Potatoes / Sweet Potatoes, Sorghum, Soybeans, Stonefr uits, Sweet Corn, Sugarcane, Swiss Chard, and Turnip Greens. D418740. 3pp

USEPA. 2014c. Guidance for Assessing Pesticide Risks to Bees. Environmental Fate and Effects Division, Office of Pesticide Program s, United States Environmental Protection Agency.

Fate Bibliography

MRID Citation Reference

44961006 Comb, A.L. (1997). Rimon (Pure) : Determination of the PhysicoChemical Properties. Report No: MAK418/970332. Unpublished study prepared by Makhteshim Chemical Works, Ltd. Huntingdon Life Sciences, Ltd. 106 p.
44961008 Lahav, H. (1998) (Carbon-14)-Rim on: Hydrolysis Under Laboratory Conditions: Lab Project Numb er: 445/973392: R-9703. Unpublished study prepared by Makhteshim Chemical Works, Ltd. Huntingdon Life Sciences, Ltd. 123 p.
45638203 Shaw, D. (1998) (Carbon-14)-"Rim on": Photolytic Degradation in Water: Lab Project Number : MAK/443: R-9705: MAK 443/973390. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 112 p.
45638204 Shaw, D. (1998) (Carbon-14)-"Rimon": Photodegradation on Soil: Lab Project Number: MAK 444/973391: R-9704: MAK/444. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 89 p.
44961009 Aikens, P. (1999) (Carbon-14 )-Rimon: Aerobic Soil Rate of Degradation: Lab Project Number: R-10030: MAK483/984569: SSHQ/164/98. Unpublished study prepared by Makhteshim Chemical Works, Ltd. and Huntingdon Life Sciences, Ltd. 102 p.
44961010 Aikens, P. (1998) (Carbon-14)-Rim on: Aerobic Soil Metabolism (Pilot Study): Lab Project Number : MAK 446: R-9415: MAK446/974308. Unpublished study prepared by Makhte shim Chemical Works, Ltd. and Huntingdon Life Sciences, Ltd. 88 p.

### 39 45638207 Shepler, K.; Schick, M. (2002) Anaerobic Aquatic Metabolism of (Carbon-14)-Novaluron: Lab Proj ect Number: 1028W-1: 1028W. Unpublished study prepared by PTRL West, Inc. 174 p.
45789203 Shepler, K.; Schick, M. (2002) Anaerobic Aquatic Metabolism of Carbon 14 Novaluron: Lab Projec t Number: 1028W-2: 1028W: UCC 2002-024. Unpublished study prepared by PTRL West, Inc. 203 p.
45638205 Shaw, D. (1999) (Carbon-14)-"Ri mon": Anaerobic Soil Metabolism: Lab Project Number: M AK/497: MAK 497/982727: R-10231. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 111 p.
45638206 Aikens, P. (1999) (Carbon-14)-"Rim on": Degradability and Fate in theWater/Sediment System: Lab Project Number: MAK 484/984634: R10031: MAK/484. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 160 p. {OPPTS 835.4300}
44961011 Shaw, D. (1998) (Carbon-14)-Rimon: Soil Column Leaching: Lab Project Number: MAK/472: R-10005: MAK472/974399. Unpublished study prepared by Makhteshim Chemical Works, Ltd. and Huntingdon Life Sciences, Ltd. 87 p.
44961012 Aikens, P. (1997) (Carbon-14)-Rimon: Adsorption/Desorption on Soil: Lab Project Number: R- 9667: MAK424: MAK424/973308. Unpublished study prepared by Makhte shim Chemical Works, Ltd. and Huntingdon Life Sciences, Ltd. 68 p.
45638201 Aikens, P. (1999) (Carbon-14)- 275-352 I: Adsorption/Desorption on Soil: Lab Project Number: MAK/528/992496: R-10639: MAK/528. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 119 p.
45638202 Shaw, D. (1999) (Carbon-14)-"Rim on": Aged Residue Soil Column Leaching: Lab Project Number: MAK 496/982726: R-10232. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 96 p.
45638403 Wilson, A. (2001) Novaluron: Terr estrial Field Dissipation Study with "Rimon" 10EC Applied to Bare Soil in Spain and Germany, 1999: Lab Project Number: MAK/547/004242: MAK/547: R-10971. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 175 p.
45638404 Willard, T. (2002) Terrestrial Field Soil Dissipation of Novaluron: Interim Study Report: Lab Project Number: AA010702: R-13885: 990W. Unpublished study prepared by American Agricultural Services, Inc. and PTRL West, Inc. 676 p.
45789204 Willard, T. (2002) Terrestrial Fi eld Study Dissipation of Novaluron: Final Study Report: Lab Projec t Number: AA010702: R-13885: 2001- 099. Unpublished study prepared by Am erican Agricultural Services, Inc. and PTRL West, Inc. 678 p.
45785801 Jenkins, W. (2002) Novaluron (Rimon 10EC): Assessment of its Potential Biological Effects on Fres hwater Aquatic Ecosystems Based

### 40 on its Application to Outdoor Mi crocosms: Lab Project Number: MAK/531: R-10698. Unpublished study prepared by Huntingdon Life Sciences Ltd. 625 p. {OPPTS 850.1950}
45638215 Jenkins, C.A. 2000. 14c "RIMON: Bioconcentration in bluegill sunfish. Unpublished study performed by Hu ntingdon Life Sciences Ltd., Suffolk, England; sponsored and submitted by-Makhteshim Chemical Works, Ltd., Beer-Sheva, Israel. Stud y No.: R-9414. Final report issued May 3, 2000.
45785802 Jenkins, C.A. 2000, 14C Novaluron: Depuration in rainbow trout following exposure to the test s ubstance for 24 hours. Unpublished study performed by Huntingdon Life Sciences Ltd., Cambridgeshire, England; sponsored and submitted by Makhteshim Chemical Works Ltd., Beer-Sheva, Israel. Study No.: PC- 14841. Experimental start date March 20, 2002, and completion date August 1, 2002 (p. 9). Final report issued September 12, 2002.

Ecological Effects Bibliography

MRID Citation Reference

45476801 Rodgers, M. (1998) "Rimon" Technical Acute Oral Toxicity (LD50) to Bobwhite Quail: Lab Project Number: MAK410/972113. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 54 p. {OPPTS 850.2100}
45499001 Hakin, B.; Norman, A.; Anderson, A. ; et al. (1989) The Acute Oral Toxicity (LD50) of GR 572 Tec hnical to the Mallard Duck: Lab Project Number: AGR 68/89647. Unpublished study prepared by Huntingdon Research Centre Ltd. 44 p. {OPPTS 850.2100}
48690102 Hubbard, P.; Beavers, J. (2011) Novaluron TGAI: An Acute Oral Toxicity Study with the Zebra Fi nch (Poephila gruttata). Project Number: 234/118, R/28269. Unpublishe d study prepared by Wildlife International, Ltd. 34p.
45499002 Hakin, B.; Norman, A.; Anderson, A.; et al. (1989) The Dietary Toxicity (LD50) of GR 572 Techni cal to the Bobwhite Quail: Lab Project Number: AGR 69/89126. Unpublished study prepared by Huntingdon Research Centre Ltd. 46 p. {OPPTS 850.2200}
45499003 Hakin, B.; Norman, A.; Anderson, A.; et al. (1988) The Dietary Toxicity (LD50) of GR 572 Tec hnical to the Mallard Duck: Lab Project Number: AGR 67/89125. Unpublished study prepared by Huntingdon Research Centre Ltd. 45 p. {OPPTS 850.2200}

### 41 45638218 Rodgers, M. (1999) "Rimon" Tec hnical: Reproduction in Bobwhite Quail: Lab Project Number: MAK411/972997: R-9417: MAK/411. Unpublished study prepared by Huntingdon Life Sciences Ltd. 291 p.
45638219 Rodgers, M. (2001) "Rimon" Tec hnical: Reproducti on in Mallard Duck: Lab Project Number: MAK412/973000: R-9418: MAK 412. Unpublished study prepared by Huntingdon Life Sciences Ltd. 243 p.
45499004 Douglas, M.; Bell, G.; Macdonald, I. ; et al. (1989) The Acute Toxicity of GR 572 Technical to Rainbow Trout (Salmo gairdneri): Lab Project Number: AGR 63(C)/891282. Unpub lished study prepared by Huntingdon Research Centre Ltd. 19 p. {OPPTS 850.1075}
45499005 Douglas, M.; Sewell, I.; Macdonal d, I.; et al. (1989) The Acute Toxicity of GR 572 Technical to Bluegill Sunfish (Lepomis macrochirus): Lab Project Number: AGR 63(D)/89960. Unpublished study prepared by Huntingdon Resear ch Centre Ltd. 20 p. {OPPTS 850.1075}
45499006 Jenkins, C. (1999) 275-352 I Acute Toxicity to Rainbow Trout (GR 572 Technical): Lab Project Number: MAK525/992450. Unpublished study prepared by Huntingdon Life Sciences Ltd. 43 p. {OPPTS 850.1075}
45638314 Jenkins, C. (1998) "Rimon" 10 EC: Acute Toxicity to Rainbow Trout: Final Report: Lab Project Nu mber: MAK/462/982146: MAK/462: R9912. Unpublished study prepared by Huntingdon Life Sciences Ltd. 46 p. 45638406 Jenkins, C. (2000) "Rimon" 10EC: Prolonged Toxicity to Rainbow Trout Under Flow Through Conditio ns 28-Day Study: Final Report: Lab Project Number: M AK/537/993312: MAK/537: R-10933. Unpublished study prepared by Huntingdon Life Sciences Ltd. 49 p.
45638216 Jenkins, C. (1998) "Rimon" T echnical: Prolonged Toxicity to Rainbow Trout Under Flow-Through Conditions, 28-Day Study: Final Report: Lab Project Number: MAK/441: MAK441/974266: R-9840. Unpublished study prepared by Huntingdon Life Sciences Ltd. 44 p
45476802 Jenkins, C. (1997) "Rimon" Tec hnical: Acute Oral Toxicity to Daphnia magna: Final Report: La b Project Number: MAK/404: MAK404/970470. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 46 p. {OPPTS 850.1010}
45499007 Jenkins, C. (1999) 275-352 I Acute Toxicity to Daphnia magna (GR 572 Technical): Lab Project Number: MAK526/992451. Unpublished study prepared by Huntingdon Life Sciences Ltd. 40 p. {OPPTS 850.1010}
45638413 Jenkins, C. (1999) "Rimon" 10 EC: Acute Toxicity to Daphnia magna: Final Report: Lab Project Nu mber: MAK/463/983514: R-9913: MAK

### 42 463. Unpublished study prepared by H untingdon Life Sciences Ltd. 45
p. 45638208 Cafarella, M. (2002) Novaluron--Acu te Toxicity to Eastern Oyster (Crassostrea virginica) Under Fl ow-Through Conditions: Lab Project Number: 11742.6141: R-14139: 011901/FI FRA/OPPTS/FT-OYSTER. Unpublished study prepared by Spri ngborn Laboratories, Inc. 67 p. {OPPTS 850.1025}
45638210 Machado, M. (2002) Novaluron--Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Flow-Through Conditions: Lab Project Number: 11742.6140: R-14138: 020499/FIFRA/OPPTS/FT-SHM. U npublished study prepared by Springborn Laboratories, Inc. 59 p. {OPPTS 850.1075}
46086203 Albuquerque, R. (2003) Rimon 10 EC : Mysid Acute Toxicity Test. Project Number: MAK/783, MAK/783/032052. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 58 p.
45638209 Machado, M. (2002) Novaluron--Acute Toxicity to Mysids (Americamysis bahia) Under Flow-Through Conditions: Lab Project Number: 11742.6142: R-14136: 011901/FI FRA/OPPTS/FT-MYSIDS. Unpublished study prepared by Spri ngborn Laboratories, Inc. 63 p. {OPPTS 850.1035}
45638211 Jenkins, C. (1998) (Carbon-14)-"Rimon": Daphnia magna Reproduction Test: Final Report: Lab Project Number: MAK/405: MAK405/974265. Unpublished study prepared by Huntingdon Life Sciences Ltd. 59 p.
45638212 Lima, W. (2002) Novaluron--Life-Cy cle Toxicity Test with Mysids (Americamysis bahia): Lab Project Number: 11742.6143: R-14140. Unpublished study prepared by Sprin gborn Laboratories, Inc. 80 p.
45638213 Barrett, K. (2001) (Carbon-14)-"R imon" Technical: Fish Early Life Stage Toxicity Test for Fathead Minnow (Pimephales promelas): Lab Project Number: MAK507: MAK507/994379: R-10281. Unpublished study prepared by Huntingdon Life Sciences Limited. 63 p. {OPPTS 850.1400}
46581401 Jenkins, C. (1998) (Carbon 14)-"Rimon": Daphnia magna Reproduction Test: Final Repor t. Project Number: MAK/405, MAK405/974265, R/9341. Unpublished study prepared by Huntingdon Life Sciences Ltd. 59 p.

45785805 Caunter, J.; Williams, T. (2002) N ovaluron Technical: Determination of Effects on the Life Cycle of the Fathead minnow (Pimephales promelas): Lab Project Numb er: AJ0047A. Unpublished study prepared by Brixham Envir onmental Laboratory. 65 p.

### 43 45638214 Caunter, J.; Williams, T. (2000) Nova luron: Determination of Effects on the Reproduction of Fathead Min now (Pimephales promelas): Lab Project Number: BL6993/B: AH0411A: MAK630/012118. Unpublished study prepared by Brixham Environmental Laboratory. 90 p. 45638215 Jenkins, C. (2000) (Carbon-14)-"Rim on": Bioconcentration in Bluegill Sunfish: Final Report: Lab Project Number: MAK498/985004: R9414: MAK/498. Unpublished study pr epared by Huntingdon Life Sciences Ltd. 173 p.
45638405 Jenkins, C. (2001) "Rimon" 10EC: An Assessment of the Bioconcentration of "Rimon" in Rainbow Trout in a Mescosm: Final Report: Lab Project Number: MAK/575/003707: R-11307: MAK/575. Unpublished study prepared by Huntingdon Life Sciences Ltd. 109 p. {OPPTS 850.1730}
45785802 Jenkins, W. (2002) (Carbon 14) N ovaluron: Depuration in Rainbow Trout Following Exposure to the Test Substance for 24 Hours: Final Report: Lab Project Number: R- 14841: MAK/775. Unpublished study prepared by Huntingdon Life Sc iences Ltd. 65 p. {OPPTS 850.1730}
45785803 Todd, M. (2002) Novaluron: De termination of Residues in the Carcass, Muscle and Viscera of Fathead Minnow (Pimephalespromelas) Following Exposure for 315 Days: Lab Project Number: R14842: MAK 777/023873. Unpublished study prepared by Huntingdon Life Sciences Ltd. 41 p. {OPPTS 850.1730, 860.1400}
45638216 Jenkins, C. (1998) "Rimon" T echnical: Prolonged Toxicity to Rainbow Trout Under Flow-Through Conditions, 28-Day Study: Final Report: Lab Project Number: MAK/441: MAK441/974266: R-9840. Unpublished study prepared by Huntingdon Life Sciences Ltd. 44 p.
45785801 Jenkins, W. R., et, al. 2002. "Nova luron ("Rimon" 10EC): Assessment of its Potential Biological Effect s on Freshwater Aquatic Ecosystems Basedon its Applications to Outdoor Microcosms.
45638221 Jenkins, C. (1998) "Rimon" Technical: Algal Growth Inhibition Assay: Final Report: Lab Project Number: MAK/449: MAK449/974268: R-9842. Unpublished study prepared by Huntingdon Life Sciences Ltd. 45 p.
45638222 Jenkins, C. (1999) 275-352 I: Alga l Growth Inhibition Assay: Lab Project Number: MAK527: R-10637: MAK527/992452. Unpublished study prepared by Huntingdon Life Sciences Ltd. 44 p.
45638223 Jenkins, C. (2001) "Rimon": Higher Plant (Lemna) Growth Inhibition Test: Lab Project Number: MAK610/003705: R-11755: MAK610. Unpublished study prepared by Huntingdon Life Sciences Ltd. 64 p.

### 44 45638411 Jenkins, C. (1998) "Rimon" 10 EC: Algal Growth Inhibition Assay: Final Report: Lab Project Number: MAK/464/98147: R-9914: MAK/464. Unpublished study prepared by Huntingdon Life Sciences Ltd. 45 p.
45638220 Gray, A. (1997) "Rimon" Technical: Acute Toxicity to Honey Bees (Apis mellifera): Lab Project Number: MAK433/973447: R-9801: MAK/433. Unpublished study prepared by Huntingdon Life Sciences Ltd. 37 p.
45638407 Gray, A. (1998) "Rimon" 10EC: Eval uation of the Effects of Insect Growth-Regulating Insecticides on Honey Bee (Apis mellifera) Colony Brood Development: Lab Project Number: MAK 435/973449: MAK 435: R-9799. Unpublished study prepared by Huntingdon Life Sciences Ltd. 181 p.
45638408 Gray, A. (1998) "Rimon" 10EC: Acut e Toxicity to Honey Bees (Apismellifera): Lab Project Number: MAK 434/973448: MAK 434: R9800. Unpublished study prepared by Huntingdon Life Sciences Ltd. 37 p. 45638407 Gray, A. (1998) "Rimon" 10EC: Eval uation of the Effects of Insect Growth-Regulating Insecticides on Honey Bee (Apis mellifera) Colony Brood Development: Lab Project Number: MAK 435/973449: MAK 435: R-9799. Unpublished study prepared by Huntingdon Life Sciences Ltd. 181 p.
45638409 Barrett, K. (2001) Novaluron: To Assess the Effect of "Rimon" 10EC to Honeybee Brood when Used in Commercial Citrus Groves: Lab Project Number: MAK 542/993030: R-10990: MAK 542. Unpublished study prepared by Huntingdon Life Sciences Ltd. 295 p. {OPPTS 850.3040}
47737801 Walsh, D. (2009) Pollinator Pesticid e Safety Trials 2007: Flonicamid. Project Number: IB/2009/PH/002/ 01. Unpublished study prepared by Washington State University. 19 p.
45638410 Sharples, A. (2001) Novaluron: Ev aluation of the Effects of "Rimon" 10 EC on Populations of Non-Target Arthropods in Citrus Groves: Lab Project Number: M AK 543: MAK543/003923: R-10991. Unpublished study prepared by Huntingdon Life Sciences Ltd. 409 p.
48194901 Scott-Dupree, C.; Conroy, L.; Harris, C. (2009) Impact of Currently Used or Potentially Useful Insecticides for Canola Agroecosystems on Bombus impatiens (Hymenoptera: Apidae), Megachile rotundata (Hymentoptera: Megachilidae), a nd Osmia lignaria (Hymenoptera: Megachilidae). Journal of Ec onomic Entomology 102(1): 177-182.
48690104 Sindermann, A.; Porch, J.; Krueger, H.; et al. (2011) Novaluron TEP: A Tier 1 Toxicity Test to Determine the Effects of the Test Substance on Seedling Emergence of Ten Speci es of Plants. Project Number:

### 45 234/119, R/28251. Unpublished stu dy prepared by Wildlife International, Ltd. 84p.

46581402 Bell, G. (2000) (Carbon 14) "Rimon " to Assess the Toxicity to the Sediment Dwelling Phase of the Mi dge Chironomus riparius. Project Number: MAK/508, MAK/508/992185, R/10339. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 85 p.

47621902 Krueger, H.; Thomas, S.; Kendall, T. ; et al. (2008) C14-Novaluron: A Prolonged Sediment Toxicity Test with Chironomus riparius Using Spiked Sediment: (Rimon 0.83 EC). Project Number: 234A/101, R/20568, 234/073/108/CHI/SED. Unpublished study prepared by Wildlife International, Ltd. 74 p.

45638224 Rodgers, M. 1998) "Rimon" Technical Acute Toxicity (LC50) to the Earthworm (Eisenia foetida): Lab Project Number: MAK 413/972973: R-9458: MAK 413. Unpublished study prepared by Huntingdon Life Sciences Ltd. 30 p.

45638225 Rodgers, M. (2001) Chlorophenyl Urea Acute Toxicity (LC50) to the Earthworm (Eisenia foetida): Lab Project Number: MAK 619/003779: R-11872: MAK/619. Unpublished study prepared by Huntingdon Life Sciences Ltd. 33 p.

46185801 Kane, T. (2004) (Carbon 14) - "R imon": Residues in Laying Hens. Project Number: MAK/810/0331178, R/15767, MAK/810. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 135 p.

45638217 Carter, J.N. Rimon Technical E ffects on Soil Non-target Microorganisms - also contract draft available

### 46 

## Appendix 1. Novaluron Uses and Application Rates

Use Maximum Single Application Rate lb ai Maximum Number of Applications per
year (minimum application interval in days unless specified) Maximum Yearly Application Rate in lbs of ai Method of Application

Outdoor flea control 0.035 17* (21) 0.60 Liquid spray spot treatment Outdoor cockroach perimeter
treatment 0.07 2* (6 months) 0.14 Liquid spray perimeter
treatment

Indoor control of litter beetles in chicken houses 0.002 1 app of treated manure/year 0.002 Liquid spray

Outdoor control of litter beetles in chicken houses 0.035 8** (46) 0.28 Liquid spray perimeter
treatment

Outdoor control of
ants 0.07 26* (14) 1.82 Liquid spray perimeter
treatment Outdoor control of flying insect pests 0.023 26* (14) 0.60 Liquid spray spot treatment

Flies in cattle and horse operations 0.436 17* (21) 7.41 Granular spot
treatment

Beetles in poultry operations 0.872 17* (21) 14.82 Granular broadcast

Beetles in poultry operations 0.232 1 app of treated manure/year 0.232 Spread manure as fertilizer

Flies in horse operations 0.024 1 app of treated manure/year 0.024 Spread manure as fertilizer

Outdoor crickets, outdoor cockroaches 0.91 NS (180)*** NS Ground application

### 47 Mosquitos in small water bodies 0.0003 a NS (90)  NS Manual

Mosquitos in small water bodies 0.0004 b NS (90)** ** NS Manual

Termites 0.00137 60 day inspection NS assume inspection every

2 months for .00822 Bait station

Bean,LowGrowing Berries 0.077 3 (7) 0.23 Ground Application, Aerial application

Potatoes / Sweet Potatoes, Head and Stem Brassica 0.08 2 (7) 0.16 Ground Application, Aerial application, Chemigation

Cucurbit Vegetables 0.08 3 (14) 0.23 Ground Application, Aerial application, Chemigation

Carrot 0.08 3 (7) 0.24 Ground Application, Aerial application, Chemigation

### 48 Fruiting Vegetables, Peanuts, Grain Sorghum, Leafy Brassica Greens, Swiss Chard, Strawberry, Turnip Greens 0.08 3 (7) 0.23 Ground Application, Aerial application, Chemigation

Soybeans 0.08 3 (10) 0.23 Ground Application, Aerial application, Chemigation

Sugarcane 0.08 5 (14) 0.39 Ground Application, Aerial application, Chemigation

Sweet Corn 0.08 5 (7) 0.39 Ground Application, Aerial application, Chemigation

Cotton 0.09 3 (7) 0.27 Ground Application, Aerial application, Chemigation

Cotton (premix with Bifenthrin) 0.062 5 (corn borer/thrips 7 days all other pests 14 days) 0.27 Ground Application, Aerial application, Chemigation

Avocado 0.13 3 (14) 0.38 Ground Application, Aerial application

Ornamentals 0.17 2 (30) 0.34 Ground Application

Bushberries 0.193 3 (10) 0.58 Ground Application, Aerial

### 49 application, Chemigation Group 11-10 Pear 0.21 3 (10) 0.62 Orchard Spray

Group 11-10 Pome 0.323 3 (10) 0.97 Orchard Spray

Stone Fruit 0.323 3 (7) 0.97 Ground Application, Aerial application, Chemigation

Apple, pear 0.33 4 (10) 0.96 Ground Application,

Airblast

Apples 0.26 1 0.26 Ground Application,

Airblast
Alfalfa, seed (spring when pets first appear) 0.078 4 (7) 0.31 Ground Application, Aerial application, Chemigation

Alfalfa, seed(spring prebloom) 0.078 4 (7) 0.16 Ground Application, Aerial application, Chemigation

Tomatoes (greenhouse) 0.078 2(7) whiteflies/thrips 3(7) other pests 0.46 Ground Application *Assumed, based on the minimum re-application interval. **Assumed, based on typical number of chicken growth cycles per year (USEPA 2012a, D403654) ***Assumed based on label claim controls pests for 180 days ****Not specified (NS) a calculated based on 1 pellet containing 0.24 mg/ai per pellet. Label lists a maximum rate of 500g of pellets in 330 gallons of water b calculated based on 1 control rod containing 21.6 mg/ai per rod. Label lists a maximum rate of 8 control rods in 200 gallons of water

### 50 

## Appendix 2. Previous Acti ons for Uses of Novaluron Crop Single Application Rate (lb ai/A) Number of Annual Applications (Application Interval in Days) Action/DP Barcode/Date Risk Conclusions

Ornamentals and Greenhouse 0.17 2 (30) Section 3 New Chemical Registration D318619 No risk concerns exist for acute or chronic direct effects to listed or non-listed fish in freshwater or estuarine/marine environments. However, greatest risk from novaluron use is to invertebrates in both media. No acute effects are expected on birds, mammals, and plants. Chronic effects are possible on birds and mammals. Adverse impacts are possible on developing insects due to the novaluron’s mode of action, which is targeted against chitin development and cuticle formation of insect larvae. Pome fruit Cotton Potato 0.32 0.09 0.08 3 (10 – 14) 3 (7 – 14) 3 (10 – 14) Tier II DWA D285477 and D285479 2/11/04 Section 3 New Use Registration DP285477, 285479, 287624, 297230 6/14/04 Head and Stem Brassica 0.04 – 0.08 3 (up to 0.16 lb ai/A) (7 – 14) Section 3 New Use Registration DP321545 2/2/06 No risk concerns exist for acute or chronic direct effects to listed or non-listed fish in freshwater or estuarine/marine environments. However, greatest risk from novaluron use is to invertebrates in both media. No acute effects are expected on birds, mammals, and plants. Chronic effects are possible on birds and mammals. Adverse impacts are possible on developing insects due to the novaluron’s mode of action, which is targeted against chitin development and cuticle formation of insect larvae. Sugarcane 0.08 5 (10 – 14) Section 18 Emergency Use Exemption DP329703 6/27/06 Head and Stem Brassica Tomato Sugarcane 0.08 0.08 0.08 (ground and aerial) 3 3 5 (7 – 10) DWA DP340579, 340581, 340583, 345672 12/13/07 Section 3 New Use Registration for tomato and sugarcane and increase in maximum use rates for brassica vegetables

### 51 Crop Single Application Rate (lb ai/A) Number of Annual Applications (Application Interval in Days) Action/DP Barcode/Date Risk Conclusions

DP340579, 340581, 340583, 345672 2/5/2008 Strawberry 0.08 (ground) 3 (7 – 10) Section 18 Emergency Use Exemption in Florida D357484 10/30/2008 Stone Fruit Bushberry 0.32 0.20 3 (7-14) 3 (10-14) DWA D357061 3/10/09 Section3 New Use Registration D358376 04/14/2009 Brassica Leafy Greens Turnip Greens 0.08 3 (7-14)

Strawberry 0.078 3 (7-10) Section 18 Emergency Use Exemption in California D364391 06/02/2009 Novaluron use on strawberry has the potential to cause adverse acute and chronicimpacts to both listed and nonlisted freshwater and estuarine/marine invertebrates. No acute adverse effects expected for fish, birds, or mammals. No chronic adverse effects expected for fish or mammals. Chronic risk expected to birds. Novaluron is not expected to cause adverse effects to terrestrial aquatic plants. Adverse impacts are possible on developing insects. Sorghum Fruiting Veg. Curcurbit Veg. Low Growing Berry Subgroup Snap and Dry Bean Swiss Chard 0.078 3 (7-14) DWA D363989 and D364309 7/16/09 Section3 New Use Registration D364309 & D364313 11/27/2009 Novaluron use has the potential to cause adverse acute and chronic impacts to both listed and non-listed freshwater and estuarine/marine invertebrates. No acute adverse effects expected for fish, birds, or mammals. No chronic adverse effects expected for fish or mammals. Chronic risk expected to birds. Risk to terrestrial plants is assumed. Sweet Corn 0.078 5 (7) Tier II DWA D378389 9/29/2010

### 52 Crop Single Application Rate (lb ai/A) Number of Annual Applications (Application Interval in Days) Action/DP Barcode/Date Risk Conclusions

Section3 New Use Registration D378620 11/18/2010 Novaluron use has the potential to cause adverse acute and chronic impacts to both listed and non-listed freshwater and estuarine/marine invertebrates. No acute adverse effects expected for fish, birds, or mammals. No chronic adverse effects expected for fish; chronic risk expected for birds and mammals. Risk to aquatic plants not expected; risk to terrestrial plants presumed due to lack of data. Crickets in residential areas and mosquito larvae in small water bodies 0.32 3 Tier II DWA D387737, D387738, D388519, and D385667 4/25/2011 0.91 3 μ g ai/L (limit of solubility) 1 Section3 New Use Registration D385667, D387408, D387407, and 389832 Novaluron has the potential to cause chronic adverse effects to birds, chronic adverse effects to mammals, adverse effects to terrestrial invertebrates, and adverse effects to aquatic invertebrates. Peanuts and soybean 0.078 3 (7) peanuts (10) soybean DWA D402324 8/27/12 Section 3 New Use Registration D401844 Risk to birds, terrestrial plants, terrestrial invertebrates, and aquatic invertebrates/mollusks

Outdoor Flea Control 0.035 17 (21) DWA D412441 8/7/13

Section 3 New Use Registration D409223, and D412299 8/14/13 The proposed new uses of novaluron may present risk to the following groups: Birds, reptiles, and land-phase amphibians (chronic), terrestrial plants, terrestrial invertebrates (contact and oral), estuarine/marine fish (chronic), benthic invertebrates (acute and chronic), aquatic vascular plants ( degradates only)

Outdoor Cockroach 0.07 2 (180) Outdoor Chicken Houses 0.035 8 (45)

### 53 Crop Single Application Rate (lb ai/A) Number of Annual Applications (Application Interval in Days) Action/DP Barcode/Date Risk Conclusions

Indoor Chicken Litter to Field 0.002 1

Outdoor Ants 0.07 26 (14) Outdoor Flying Insect Pest 0.023 26 (14)

Flies in Cattle Operation 0.436 17 (21)

Poultry Operation 0.872 17 (21)

Poultry Manure to Field 0.232 1

Horse Barns 0.436 17 (21) Horse Manure to Field 0.024 1

Avocado 0.13 3 (14) IR-4 New/revised

uses D419642 11/21/14 DW assessment D418740 9/2/14 Novaluron use has the potential to cause adverse acute and chronic impacts to both listed and non-listed freshwater and estuarine/marine invertebrates. Chronic risk expected to birds. Chronic risk to estuarine/marine fish and risk to terrestrial plants is assumed No acute adverse effects expected for fish, birds, or mammals. No chronic adverse effects expected for fish or mammals. Bean, Low-Growing Berries 0.077 3 (7)

Bushberries 0.193 3 (10) Carrot, Fruiting Vegetables, Leafy Brassica Greens, Peanuts, Grain Sorghum, Strawberry, Swiss Chard, Turnip Greens 0.08 3 (7)

Cotton 0.09 3 (7) Cucurbit Vegetables 0.08 3 (14) Head and Stem Brassica, Potatoes / Sweet Potatoes 0.08 2 (7)

### 54 Crop Single Application Rate (lb ai/A) Number of Annual Applications (Application Interval in Days) Action/DP Barcode/Date Risk Conclusions

Ornamentals 0.17 2 (30) Group 11-10 Pear 0.21 3 (10) Group 11-10 Pome 0.323 3 (10) Soybeans 0.08 3 (10) Stone Fruit 0.323 3 (7) Sugarcane 0.08 5 (14) Sweet Corn 0.08 5 (7)

### 55 

## Appendix 3. Structures of Novaluron and its Degradates

Chemical Name Structure

Novaluron

3-Chloro-4-[I, 1,2-trifluoro-2- (trifluoromethoxy)ethoxy]phenyl] - amino]carbonyl]-2,6- difluorobenzamide

275-352I

1-[3-chloro-4-(1,1,2-trifluoro-2- trifluoromethoxyethoxy)phenyl urea

275-309I

3-chloro-4-(1,1,2-trifluoro-2- trifluoromethoxyethoxy)aniline

275-158I, DFBA

2,6-difluorobenzoic acid

275-157I

2,6-difluorobenzamide

275-143I

4-Amino-2-chlorophenol

### 56 

## Appendix 4. Major Degradates Ch lorophenyl Urea and Chloroaniline

A4-1. Fate and transport properties for degradate chlorophenyl urea (275-352I or 1- [3-Chloro-4-(1,1,2-trifluoro-2-tr ifluoromethoxyethoxy)phenyl]urea

Parameters Value and Unit Reference

Molecular Formula C 10 H 7 ClO 3 F 6 N 2 MRID 45638201

Molecular Weight 352.5 MRID 45638201

Molecular Structure MRID 45638206

Smiles NC(=O)Nc2cc(Cl)c(OC(F)(F)C (F)OC(F)(F)F)cc2 EPI Suite 4.1

Solubility in water at 20 o C 33 ppm MRID 45638201

Vapor Pressure 1.03 x 10 -5 mm Hg EPI Suite 4.1

Henry’s Constant at 25 o C 8.5x10 -12 atm•m 3 /mol EPI Suite 4.1

Soil Partition Coefficient (K oc ) 1 2277 (average of 4 Koc value) MRID 45638201 Sandy loam 1950 Sandy loam 2088 Loamy sand 2563 Clay loam 2505

Soil Adsorption Kd 1 40.2 (average of 4 Kd value) MRID 45638201 Sandy loam 35.1 Sandy loam 16.7 Loamy sand 61.5 Clay loam 47.6

Aerobic Soil Metabolism T 1/2 1 47.1 days MRID 44961009 Sandy clay loam 46.5 days Clay loam 45.9 days

Aerobic aquatic metabolism half-life 1 184.36 days MRID 45638206 Bury Pond water-clay loam 108.5 days Meadow water-loamy sand 35.5 days

Aqueous Photolysis T 1/2 stable No data

1 Guidance for Selecting Input Parameters in Modeling the Environmental Fate an d Transport of Pesticides; Oct. 22, 2009

### 57 A4-2. Fate and transport properties for degradate chloroaniline (275-309I or 3- chloro-4-(1,1,2-trifluoro-2-tr ifluoromethoxyethoxy)aniline)

Parameters Input Value and Unit Source of Info/Reference

Molecular Formula C 9 H 6 ClO 2 F 6 N EPI Suite 4.1

Molecular Weight 309.6 EPI Suite 4.1
Molecular Structure MRID 45638206

Smiles NC1=CC=C(C(=C1)Cl)OC(F)( F)C(F)OC(F)(F)F EPI Suite 4.1

Vapor Pressure 3.49 x 10 -3 mm Hg EPI Suite 4.1

Henry’s Constant at 25 o C 8.04x10 -8 atm•m 3 /mol EPI Suite 4.1

Solubility in water at 25 o C 13.87 ppm EPI Suite 4.1

Soil Partition Coefficient (K oc ) 918.8 EPI Suite 4.1

Aerobic Soil Metabolism T 1/2 180 EPI Suite 4.1

Aerobic aquatic metabolism half -life 360 days EPI Suite 4.1 Anaerobic Aquatic Metabolism Hal f-life 1,620 days EPI Suite 4.1

Hydrolysis T 1/2 (pH7) stable No data

Aqueous Photolysis T 1/2 stable No data

### 58 

## Appendix 5. Screening Level Models to Evaluate Potential Importance of Drinking Water and I nhalation Exposure Pathways

SIP (Screening Imbibition Program, v1.0) was used to calculate an upper bound estimate of novaluron exposure via drinking water us ing solubility (0.003 mg/L), the most sensitive acute and chronic avian to xicity endpoints (bobwhite quail, LD 50 

### > 2000 mg ai/kg-bw; bobwhite quail and mallard duck NOAEC = 301 and 9.8 mg ai/kg-diet respectively) and the most sensitive acute a nd chronic mammalian toxicity endpoints (rat LD 50 

### >5000 mg ai/kg-bw and NOAEL = 50 mg ai/kg-bw). The model indicated that there are no acute or chronic concerns to birds and mammals through the drinking water exposure pathway (Tables XX and XX).

Table A5.1. SIP Mammalian Results for Novaluron Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 0.0005 0.0005 Adjusted toxicity value (mg/kg-bw) 3845.8028 38.4580 Ratio of exposure to toxicity 0.0000 0.0000

Conclusion* Drinking water exposure alone is NOT a potential

concern for mammals Drinking water exposure alone is NOT a potential

concern for mammals

Table A5.2. SIP Avian Results for Novaluron
Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 0.0024 0.0024 Adjusted toxicity value (mg/kg-bw) 17800.0000 0.4862 Ratio of exposure to acute toxicity 0.0000 0.0050

Conclusion* Drinking water exposure alone is NOT a potential concern for birds Drinking water exposure alone is NOT a potential concern for birds

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non-target animals.



### STIR (Screening Tool for Inhalation Risk, v1.0) was used to calculate an upper bound estimate of novaluron exposure via inhalati on using molecular weight (492.7 g/mole), vapor pressure (1.20 x 10 -7 

### mmHg), high end application ra tes (ground: 0.91 lb ai/A; aerial: 0.33 lb ai/A), most sensitive acute avian toxicity endpoint (bobwhite quale, LD 50 

### > 2000 mg ai/kg-bw), and most sensitive acut e oral and inhalation mammalian toxicity endpoints (rat, LD 50 

### = >5000. mg ai/kg-bw and 4-hr LC 50 

### > 2.04 mg ai/L, respectively). The results indicated that inhalation alone is not a potential pathway of concern for birds or mammals.

### 59 Table A5.3. STIR Avian (0.020 kg) Results for Novaluron
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 3.18E-03

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 4.00E-04 Adjusted Inhalation LD 50 4.55E+00 Ratio of Vapor Dose to Adjusted Inhalation LD 50 8.79E-05 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 9.62E-02(g) 3.17E-02(a)

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 2.11E-02(g) 6.97E-03(a) Exposure not Likely Significant

Table A5.4. STIR Mammalian (0.15 kg) Results for Novaluron
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 3.18E-03 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 5.03E-04 Adjusted Inhalation LD 50 1.21E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 4.14E-06 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 1.21E-01(g) 3.98E-02(a) Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 9.95E-04(g) 3.28E-02(a) Exposure not Likely Significant