### Registration Decision for the New Active Ingredient Momfluorothrin

1 Executive Summary

The U.S. Environmental Protection Agency
, hereafter referred to as EPA
, is granting an unconditional registration under section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the new active ingredient, momfluorothrin, formulated as four

manu facturing

- use products and five end

- use product s

. Momfluorothrin belongs to the synthetic pyrethroid class of chemicals and is a broad spectrum insecticide effective against flying, crawling, and stinging insect s and other arthropod pests. The uses for this new chemical include in door and outdoor spot and crack

- and

- crevice treatments in residential and commercial settings
, including application to indoor perimeters and mattresses to control bed bugs

. T he five end

- use products are formulated , in comb ination with previously registered active ingredients, as read y

to

- use aerosols.

The dat abase submitted to support the assessment of human h ealth r isk is complete . T he proposed uses are non

- food uses and adequate exposure data are available to assess potential residential and occupational exposure

. T here are no risk estimate s of concern for human health.
Results from a screening

- level ecological risk a ssessment indicate low potential for risks to non

target organisms. While ecotoxicological uncertainties have been identified (e.g., avian reproduction toxicity, avian/passerine acute oral toxicity, benthic invertebrate chronic toxicity, estuarine/marine acute and chronic toxicity, aquatic nonvascular plant toxicity, terrestrial plant toxicity), the environmental fate and ecotoxicity databases are sufficient for assessing the risks associated with the proposed uses.
Momfluorothrin is considered practically non

- toxic to birds and mammals. Although

m omfluorothrin is classified as highly toxic to f ish, aquatic invertebrates, and terrestrial invertebrates, predicted exposures from ready

- to

- use aerosol formulations are based on label instructions that prohibit direct application to water. Furthermore, the use patterns involve spatially limited areas

. To mitigate potential exposure to smaller water bodies in close proximity to treated areas, outdoor applications are limited to spot and crack

- and

- crevice treatments, and product labels prohibit application within 25 feet of water. To reduce risk to insect pollinators, application is prohibited if bees are foraging in treatment areas

.

M omfluorothrin is efficacious against several pests of public health concern, including flies, mosquitoes, wasps, hornets, yellow jackets, roaches, ticks, bed bugs, scorpion s, centipedes , and certain species of ants and spiders

. Additionally , momfluorothrin has a l ow er ecological hazard profile relative to alternative registered products across several taxa

.

Page 2 of 20

### 2 Requested Action

On January 10, 2013
, EPA received an application to register products containing the new active ingredient , momfluorothrin, an insecticide for non

- food indoor and outdoor residential and commercial use

. Proposed Use Pattern: Indoor and outdoor spot and crack

- and

- crevice tr eatments in residential and commercial settings, including application to ind oor perimeters and mattresses

. Target Pests: F lying, crawling, and stinging insects and other arthropod pests, including: flies, mosquitoes, wasps, hornets, yellow jackets, roach es, ticks, bed bugs, centipedes, scorpions, and certain species of ants and spiders.
Applicant s : I2L Research USA Inc., 1330 Dillon Heights Ave., Baltimore, MD 21228

– 1199, on behalf of Sumitomo Chemical Company, LTD., 27

– 1, Shinkawa 2

- Chome, Chuo

- Ku, Toky o 104

– 8260, Japan; and McLaughlin Gormley King Co., 8810 Tenth Ave North, Minneapolis, MN 55427

- 4319.



### 3 Chemical Information

Chemical Name: Momfluorothrin, 2,3,5,6

- tetrafluoro

- 4

- (methoxymethyl)benzyl ( EZ )

- ( 1RS,3RS;1RS,3SR )

- 3

- (2

- cyanoprop

- 1

- enyl)

- 2,2

- dimethylcyclopropanecarboxylate

EPA PC Code: 016331

Chemical Abstracts Service (CAS) Number: 609346

- 29

- 4

IRAC M ode o f A ction Classification: Group 3A
, Sodium Channel Modulator

Mode of Action: Axonic poison ; k eep s sodium channels in the neuronal membranes open , leading to hyperexcitation and paralysis

.



### 4 Human Health Risk Assessment

Provided below is a summary of the human health effects and risk of momfluorothrin, as assessed in the document entitled, “ Momfluorothrin. Human Health Risk Assessment for a Proposed Use of the New Active Ingredient in Indoor Residential Settings and Outdoors in Commercial/Residential Settings

. ” The database is complete and the assessment resulted in no risk estimates of conce rn

. 

### 4.1 Hazard Characterization

Momfluorothrin has been evaluated for a variety of toxic effects in experimental toxicity studies. Neurotoxic effects ( i.e., tremors) consistent with Type I pyrethroids were o bserved following oral gavage. No neurotoxic effect s were observed throughout the database followi ng dietary or

Page 3 of 20dermal exposure. This is consistent with other pyrethroids, which are metabolized and excreted from the system relatively quickly following dietary exposure, in contrast to bolus/gavage dosing, w hich results in greater maximal plasma concentrat ions immediately following exposure

. Thus , an internal dose sufficient to disrupt the sodium channels is unlikely to be achieved via dietary exposure. F ollowing dietary administration, however, decreased bod y weight and liver toxicity in rats, mice, and dogs were observed, leading to tumor formation in male rats at high

dos es following chronic exposure. In addition, liver toxicity was also observed following 28

- da y inhalation exposure to rats. No treatment

- re lated neurotoxic effects were observed following inhalation exposure.
No increased pre

- or post

- natal susceptibility was observed following developmental toxicit y studies in rat s and rabbit s

. No signs of neurotoxicity were observed following post

- natal exposure to pups in a 2

- generati on reproductive toxicity study. Increased time to sexual maturation was observed in both high

- dose male and female rats in the 2

- generation reproductive toxicity study. The slight increases in sexual male maturation times w ere considered within normal biological variation (~1.3 days) and are consistent with signifi cantly decreased body weights. However, increased sexual maturation in females is considered treatment

- related as the effect was more pronounced (~3 days) and occurred in the absence of significant body

- weight decreases. This effect occurred in the presence of maternal toxicity including significantly decreased body weights and increased hepatocellular hypertrophy, and at a dose approximately 4

- fold hi gher than the point of departure (POD) selected for risk assessment.
Momfluorothrin did not result in any systemic toxicity following dermal exposure for 28 days up to the limit dose. Low systemic toxicity via the dermal route is most likely due to the low potential for derma l absorption through the skin. A dermal penetration study for momfluorothrin is available, and based on the available data a dermal

- absorption factor of 3.5% was considered appropriate for risk assessment. This is consistent with re sults from other pyrethroids which in general have a low dermal

- absorption value of 5% or less.
No evidence of immunotoxicity or genotoxicity w as identified in the database. Momfluorothrin is classified as “not likely to be carcinogenic to h umans at dose s that do not result in a mitogenic response

. ” This classification is based on an increased incidence of liver adenomas and carcinomas in both sexes of Wistar rat , as well as supporting mechanistic studies demonstrating a mitogenic mode of action based on induction of liver cytochrome p450, resulting in a proliferative (mitogenic) response and eventual tumor formation. Genotoxicity studies were negative. A linear quantification of cancer risk was not required and t he doses selected for risk assessment are p rotective of potential carcinogenic effects

. 4.1.1 Safety Factor
The Agency will apply a 3X safety factor based on p harmacokine tic considerations for infants and children < 6 years old. The 3X is based on an approximation of increased deltamethrin (the index chemical for pyrethroids) concentrations predicted in juvenile rats ( 10

- and 21

- day s old ) compared to 90

- day old adult rat s. The 3X is considered to be sufficiently prote ctive because 1) increased juvenile sensitivity is not expected at low environmental concentrations; 2) age

dependent physiol ogically

- based pharmacokinetic models predict a 3

- fold increase in juvenile brain tissue compared to adults; and 3) the pharmacokin etics of pyrethroids as a group are

Page 4 of 20sufficiently similar that significant deviations from the predicted 3

- fold increase in concentrations are not expected.

Furthermore, t he toxicology database for momfluorothrin is complete. T here are no residual uncertainties with regard to assessment of pre

- and post

- natal susceptibility. Acceptable developmental toxicity studies in rats and rabbits and an acceptable 2

- generation reproduction study in rats are available for momfluorothrin

.

In the developmental toxicity study, tremors were observed in dams. However, no effects were observed on the developing fetus. A slight delay in female sexual maturation and decreased pup body weights were observed in the 2

- generation study; however, this effect only occurred in the high

- dose group and in the presence of significant maternal toxicity. T he degree of concern for these effects in infants is low because the rat reproductive and offspring effects have clearly defined no observed

- and lowest observed

- adverse effects levels ( NOAELs and LOAELs ), and the POD selected for risk assessment is protective of these effects. N o neurotoxic effects were observed in pups or dams in the 2

- generation reproductive toxicity study

. After reviewing the extensi ve body of peer

- reviewed literature on pyrethroids, the Agency has no residual uncertainties regarding age

- related sensitivity for women of child

- bearing age as well as for all adult populations and children >6 years of age, based on the absence of pre

- nat al sensitivity observed in 76 guideline studies for 24 pyrethroids and the scientific literature. Additionally, no evidence of increased quantitative or qualitative susceptibility was seen in the pyrethroid scientific literature related to pharmacodynamic s.
Finally, t here are no residual uncertainties in the exposure database. The proposed uses are non

food uses, and adequate data are available to assess potential occupational and residential exposure s

. 4.1.2 Cumulative Effects

P yrethroids and pyrethrins s hare a common mechanism of toxicity; chemicals in this group interact similarly with voltage

- gated sodium channels
, ultimately leading to neurotoxicity. A cumulative risk a ssessment (CRA) for pyrethroids/ pyrethrins was completed in 2011. No cumulative risks of concern were identified

. Further information regarding EPA’s efforts to evaluate the risk of exposure to pyrethroids and pyrethrins is available at: http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids

- pyrethrins.html

. EPA has determined that, based on its chemical structure and the observation of neurobehavioral effects consistent with Type I pyrethroids, momfluorothrin shoul d be included in the common mechanism grouping for pyrethroids and pyrethrins. Thus, as part of the assessment for the proposed uses of momfluorothrin, EPA performed a quantitative exposure and risk assessment to determine if these uses will significantly contribute to or change the overall findings of the 2011 pyrethroid s/pyrethrins CRA.

The assessment utilized the momfluorothr in relative potency factor of 0.19 (as compared to deltamethrin, the index chemical for the pyrethroids )
, as well as the same exposure algorithms and inputs that were used in the CRA

. Adult indoor exposures and cumulative risks are currently

Page 5 of 20driven by the cypermet hrin indoor use pattern with a margin of exposure (MOE) of 3,900, which is lower than the momfluorothrin MOE of 81,000

. The cypermethrin indoor use pattern also drives the CRA for children’s indoor exposure and risk, with a combined (dermal and incidental oral) MOE of 720, which is lower than the momfluorothrin MOE of 15,000. Thus, the risk estimates for momfluorothrin do not exceed those previously considered in the pyrethroid s/pyrethrins CRA.

Based on the se findings, EPA has determined that the proposed uses of the new active ingredient, momfluorothrin will not contribute significantly to or change the overall findings of the 2011 pyrethroid s/pyrethrins cumulative risk assessment.

4.1.3 Toxicological Endpoints

Route

- specific toxicity studies were selected for assessment of short

- term incidental oral and short

- and intermediate

- term inhalation exposures (See Table 1)

. A der mal POD was not chosen because systemic toxicity was not seen in a 28

- day dermal toxicity stud y in rats up to the limit dose . As toxicological effects through the inhalation and oral routes of exposure are d ifferent
, these exposure routes were not combined in the assessment.

Table 1. Summary of Toxicological Doses and Endpoints for Momfluorothrin for Use in Human Health Risk Assessments Exposure/ Scenario Point of Departure Uncertainty/ Safety Factors RfD/PAD, Level of Concern Study and Toxicological Effects

Incidental Oral

Short

- Term (1

- 30 days) NOAEL = 25 mg/kg/day UF A = 10x UF H = 10x

SF = 3X Residential LOC for individuals < 6

years old = 300 Developmental Toxicity Study (rat)

. MRID: 49020016

. LOAEL = 75 mg/kg/day based on tremors observed in dams at the high

- dose. Dermal Short

- Term (1

- 30 days) and Intermediate

- Term (1

- 6 months) In a 28

- day dermal toxicity study in rats, no dermal toxicity was observed up to the limit dose (1,000 mg/kg/day) . No evidence of increased susceptibility was observed, and low dermal absorption value was reported. Therefore, no dermal assessment is recommended

. Inhalation Short

- Term (1

- 30 days) and Intermediate

- Term (1

- 6 months) NOAEL = 0.150 mg/L UF A = 3x UF H = 10x LOC for MOE = 30 28

- Day Inhalation toxicity (rat)

. MRID: 49020012 LOAEL = 0.300 mg/L based on increased liver weights, AST, and cholesterol.

Cancer (oral) Classification: Not likely to be carcinogenic to humans at doses that do not result in a mitogenic response, based on negative genotoxicity data and mechanistic data supporting a non

- linear mode of action (induction of cytochrome p450 with proliferative response) for liver tumors in male and female rats. Doses selected for risk assessment are protective of carcinogenicity.
Point of Departure (POD) = A data point or an estimated point derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environment ally relevant human exposures. NOAEL = no observed adv erse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from ani mals to humans (interspecies). UF H = potential variation in sensitivity among members of the hu man population (intraspecies). SF = Safety Factor. cPAD = chr onic population adjusted dose. RfD = reference dose. N/A = not applicable. HEC = human equivalent concentration. HED = human equivalent dose.
For the incidental oral assessments, EPA is establishing an overall LOC of 300. This LOC is ba sed on standard inter

- and intra

- species uncertainty factors of 10X, and an additional 3X safety factor based on pharmacokinetic considerations for infants and children <6 years old.

Page 6 of 20For inhalation assessments, EPA is establishing an overall LOC of 30. Th e standard interspecies extrapolation uncertainty factor can be reduced from 10X to 3X based on a human equivalent concentration calculation accounting for pharmacokinetic interspecies differences. The intraspecies uncertainty factor remains at 10X.



### 4.2 Exposu re and Risk Characterization

4.2.1 Dietary Exposure and Risk
Based on the proposed uses, exposure to momfluorothrin through food or drinking water is not expected; thus, a dietary risk assessment is not required.

4.2.2 Residential Exposure and Risk
Based on the proposed uses of momfluorothrin, EPA has determined that there is potential for

e xposure in residential settings. In assessing residential exposure and risk, EPA considered exposure to residential handlers (i.e., adult individuals involved in the pesticide application process), as well as potential post

- applicat ion exposure to residues for young children

. 4.2.2.1 Residential Handler Exposure and Risk:
The proposed uses of momfluorothrin in indoor and outdoor residential settings may resu lt in adult residential handler exposure. This type of e xposure is expected to be only short

- term in duration (i.e., 1 to 30 days)
, as intermediate

- or long

- term exposures are not likely based on the intermittent nature of application s by homeowners. Since no dermal hazard was identified for momfluorothrin in the toxicological database, only inhalation exposure was assessed . The resulting MOE of 440,000 is not of concern
, as EPA’s LOC for this route of exposure is an MOE of less than 30

. 4.2.2.2 Residential Post

- Application Exposure and Risk
The proposed uses of momfluorothrin in indoor residential settings may also result in post

application exposure, which is expected to be only short

- term in duration (i.e., 1 to 30 days). Incidental oral (hand

- to

- mouth and object

- to

- mouth ) exposures to residues deposited from indoor spot, crack

- and

- crevice, and bed bug treatments were assessed for children 1 to <2 and 3 to <6 years of age. T he resulting MOEs for all scenarios , ranging from 8,300 to 240,000, are not of

concern , as EPA’s le vel of concern (LOC) is an MOE of less than 30 0

. 4.2.3 Aggregate Exposure and Risk
Based on the proposed uses, exposure to momfluorothrin through food or drinking water is not expected; thus, a quantitative aggregate risk assessment is not required at this time.

4.2.4 Occupational Exposure and Risk
In assessing occupational exposure and risk, EPA assessed exposure to occupational handlers (i.e., adult individuals involved in professional pesticide applications). In consideration of the use patterns and baseline personal protective equipment used by professional applicators, exposures

Page 7 of 20are expected to be less than those quantitatively presented for residential scenarios , and no risks are expected

. 4.2.4.1 Occupational Handler Exposure and Risk

O ccupational handler exposure is expected to be short

- or intermediate

- term in duration (i.e., 1 to 30 days , or 1 to 6 months ). Since no dermal hazard was identified for momfluorothrin in the toxicological database, only inhalation exposure was assessed. The resulting MOE of 4,900 ,000 is not of concern, as EPA’s level of concern (LOC) is an MOE of less than 30.

4.2.4.2 Occupational Post

- Application Exposure and Risk
Although a specific re

- entry interval is not required on the product labels, post

- application exposure is not expected, and no risks of concern are expected from this scenario. Furthermore, no dermal hazard has been identified for momfluorothrin in the tox icological database.



### 5 Ecological Risk Assessment

Provided below is a summary of the environmental fate and ecological risks of momfluorothrin, as assessed in the document entitled, “ Environmental Fate and Ecological Risk Assessment for the Section 3 New Chemical Registration of the Pyrethroid Insecticide Momfluorothrin .”
Results from a screening

- level ecological risk a ssessment indicate low potential for risks to non

target organisms. While ecotoxicological uncertainties have been identified (e.g., avian reproduction toxicity, avian/passerine acute oral toxicity, benthic invertebrate chronic toxicity, estuarine/marine animal acute and chronic toxicity, aquatic nonvascular plant toxicity, terrestrial plant toxicity), the environmental fate and ecotoxicity databases are sufficient for assessing the risks associated with the proposed uses.
Momfluorothrin is considered practically non

- toxic to birds and mammals. Although

m omfluorothrin is classified as highly toxic to fish, aquatic invertebrates, and terrestr ial invertebrates, predicted exposures from ready

- to

- use aerosol formulations are expected to be spatially restricted to small areas. To mitigate potential exposure to smaller water bodies in close proximity to treated areas, outdoor applications are limited to spot and crack

- and

- crevice treatments, and product labels prohibit application within 25 feet of water. To reduce risk to insect pollinators, application is prohibited if bees are foraging in treatment areas

. 

### 5.1 Environmen tal Fate

Momfluorothrin degrades through a combination of biotic and abiotic reactions, and is slightly persistent in the environment. Under acidic and neutral conditions
, momfluorothrin is relatively stable to hydrolysis, but it undergoes hydrolysis at a pH of 9
, with half

- lives ranging from 7 to 12 days

. Momfluorothrin is susceptible to aqueous photolysis with a half

- life of 32 days. It biodegrade s in aerobic soils with half

- lives of < 5 days, and under aerobic aq uatic systems with half

- lives of < 3 days.

Page 8 of 20Momfluorothrin is considered sligh tly mobile in soils and its potential to leach into groundwater is low

. If released to water, momfluorothrin will rapidly partit i on to the sediment compartment. In an acceptable aquatic metabolism study, m omfluorothrin degrade d rapidly with a reported half

- life < 3 days. Momfluorothrin has a log octanol

- water partition coefficient ( log K ow ) of <3, and thus has low potential to accumulate in aquatic organisms such as fish

.



### 5.2 Ecological Exposure

Measures of exposure for pesticide ecological and environmental fate risk assessments are typically based on aquatic and terrestrial models that calculate estimate d environmental concentrations (EECs) using labeled application rates and methods for broadcast

- applied pesticides

. However, since the proposed momfluorothrin end

- use products are formulated as aerosol spray cans for localized uses, the exposure assessment for momfluorothrin is qualitative in nature.

5.2.1 Exposure to Aquatic Life
It is possible for aquatic organisms to be exposed to momfluorothrin via surface water contamination from pesticide drift and runoff. However, momfluorothrin is not expected to bioaccumulate in aquatic organisms. Furthermore, b ased on the proposed outdoor use patterns (i.e., spot and crack

- and

- crevice treatments) and proposed label prohibitions against application to or near water bodies, EPA believes that the potential for momfluorothrin to reach aquatic habitats and result in exposure to non

- target organisms is low.

5.2.2 Exposure to Terrestrial Wildlife, Plants, and Beneficial Invertebrates

It is possible that mammals and birds (surrogates for terrestrial

- phase amphibians and reptiles) may be exposed to momfluorothrin via consumption of treated items contaminate d by direct spray or spray dri ft as a result of application. P lants and non

- target invertebrates may also be exposed to momfluorothrin via pesticide drift and runoff

. However, b ased on the proposed outdoor use patterns (i.e., spot and crack

- and

- crevice tre atments) and proposed label language to reduce inadvertent drift and runoff , EPA believes that the potential for momfluorothrin to result in exposure to non

- target terrestrial organisms is low.



### 5.3 Ecological Effects

In screening

- level ecological risk assessments, effects characterization describes the types of effects a pesticide can have on aqua tic and terrestrial organisms. This characterization is based on toxicity data for birds, mammals, fish, aquatic and terrestrial invertebrates, and aquatic and terrestrial plants for technical grade momfluorothrin , as well as for a typical formulated end

- use product ( e.g., momfluorothrin co

- formulated with phenothrin ). B irds are used as surrogates for reptiles and terrestrial

- phase amphibians and freshwater fish are used as surrogates for aquatic

phase amphibians

.

Page 9 of 205.3.1 Aquatic Organisms

5.3.1.1 Freshwater Fish
Momfluorothrin is classified as very highly toxic to freshwater fish. The acute toxicity of technical grade momfluorothrin was evaluated in several species, with 96

- hour LC 50 values ranging from 1.2 μg a.i./L in rainbow trout to 7.6 μg a.i./L in fathead minnow

. A study assessing the acute toxicity of a formulation containing 0.12 % momfluorothrin and 0.25% phenothrin in rainbow trout yielded 96

- hour LC 50 values of 1.3 μg momfluorothrin/L and 6.6 μg phenothrin/L, indicating that the acute toxicity of momfluorothrin to rainbow trout is not enhanced in mixtures compared to momfluorothrin alone.

A 32

- day chronic toxicity st udy in fathead minnow showed no significant effects to embryo hatching success, the number of live normal larvae at hatch (i.e., larval survival ), post hatch survival, total length, and dry weight at concentrations up to 3.1 μg a.i./L, yielding a 30

- day NO AEC survival value of 3.1 μg a.i./L.

5.3.1.2 Freshwater Invertebrates
Momfluorothrin is classified as very highly toxic to freshwater invertebrates. The acute toxicity of momfluorothrin was evaluated in daphnia, with a 48

- hour EC 50 of 7.8 μg a.i./L . A 48

- hour da phnia test with a formulation containing 0 .12% momfluorothrin and 0.25% phenothrin yielded

an EC 50 of 16.5 μg a.i./L for momfluorothrin , indicating that the toxicity of momfluorothrin in mixtures is similar to momfluorothrin alone.

Two momfluorothrin chronic toxicity studies were submitted for freshwater invertebrates; a 21

- day da phnia lifecycle toxicity study , and a 49

- day midge lifecycle test in a water

- sediment system

. Dry weight, length, number of live offspring, time to first brood, and successful birth rate were all significantly affected endpoints at the highest concentration tested, (LOAEC = 9.3 μg a.i./L
, NOAEC = 3.1 μg a.i./L ) in the chronic daphnia study. The sediment toxicity test with midge determined statistically significant effects to ma le development rate and combined male

female development rate at concent rations as low as 13 μg a.i./kg

- sediment (1.8 μg a.i./L pore water), the lowest test concentration. As a definitive NOAEC value was not determined from the chronic midge study, there i s uncertainty surrounding the momfluorothrin toxicity threshold for this taxon.

5.3.1.3 Estuarine/Marine Fish and Invertebrates

A cute and chronic estuarine/marine fish or estuarine/marine invertebrate toxicity studies were waived for momfluorothrin. B ased on the proposed outdoor use patterns (i.e., spot and crack

and

- crevice treatments) and proposed label prohibitions against application to or near water bodies, EPA believes that the potential for momfluorothrin to reach estuarine/marine habitats is low.

5.3.1.4 Aquatic Plants

The 7

- day toxicity of momfluorothrin to aquatic vascular plants was evaluated for Lemna gibba
, with an IC 50 greater than 2,500 μg a.i./L. The 96

- hour toxicity of momfluorothrin to aquatic non

Page 10 of 20vascular plants was evaluated for Pseudokirchneriella su bcapitata , although an EC 50 could not be reliably determined because of potential interference from the co

- solvent. B ased on the proposed outdoor use patterns (i.e., spot and crack

- and

- crevice treatments) and proposed label prohibitions against application to or near water bodies, EPA believes that the potential for momfluorothrin to reach aquatic habitats is low.

5.3.2 Terrestrial Wildlife, Plants and Benef icial Invertebrates

5.3.2.1 Mammal s
Mammalian toxicity data conducted on laboratory rats were used to approximate toxicity to wild mammals. Based on the reported oral LD 50 value of >2,000 mg/kg

- bw for a 15.5% momfluorothrin formulation , momfluorothrin is considered practically non

- toxic to small mammals. Acute dermal testing with rats also yielded an LD 50 >2,000 mg/kg

- bw

. An acute inhalation toxicity study, while producing no mortalitie s, found clinical signs in female rats exposed to 1.03 mg/L, including tremor s , tremor s of tail, atax ic gait or urinary incontinence.

5.3.2.2 Birds
The results of acute oral and dietary toxicity testing for momfluorothrin indicate that it is practically non

- toxic to avian species , including passerine species

. In acute oral toxicity studies, the LD 50 value for bobwhite quail ( Colinus virginianus ) was >2250 mg a.i./kg

- bw
, and no clinical signs of toxicity were ob served at any treatment level

. Avian acute oral toxicity testing with zebra finch ( Poephila guttata ) did not yield a NOAEC due to regurgitation at the lowest dose tested. Even if the birds that regurgitated the dose were counted as mortalities, however, the LD 50 would still be greater than 2,250 mg/kg

- bw, the highes t dose tested. In sub

- acute dietary toxicity studies, the LC 50 for momfluorothrin was >5,620 mg a.i./kg

- diet for mallard duck ( Anas platyrhynchos ) and bobwhite quail.

5.3.2.3 Terrestrial Invertebrates
Momfluorothrin is classified as highly toxic to honey bees ( Apis mellifera ) , based on an acute contact LD 50 value of 0.20 μg a.i./bee and an oral LD 50 value or 5.08 μg a.i./bee. A honey bee foliar residue toxicity study for alfalfa treated with 0.1% momfluorothrin and 0.2% phenothrin yielded an RT 25 (residual time to 25% mortality) of less than three hours

.

In a su b

- a cute earthworm toxicity test , t he LC 50 following a 14

- day exposure was determined to be 97.6 mg a.i ./kg soil dry weight, and the 14

- day NOAEC was determined to be 15.6 mg a.i./kg soil dry weight based on body

- weight change.

5.3.2.4 Terrestrial Plants

T he t oxicity of momfluorothrin to seedling emergence and vegetative vigor in terrestrial plants was evaluated for monocot s and in a dual

- concentration limit test. Observations of phytotoxic response (percentage of necrotic area, effects on plant length, dry wei ght and germination) following exposure to a formulation containing 0.1% momfluorothrin and 0.2% phenothrin at rates of 500 g/10 m 2 were limited to monocot necrosis
, whereas exposure at rates of 5000 g/10

m 2 resulted in observed phytotoxic response encompa ssing reduced germinati on, necrotic area,

Page 11 of 20and height. Due to the observed toxicity at one of the limit doses tested, the limited number of crop species tested
, and because it is uncertain whether the selected application rates are representative of exposur e that would be expected to result from lab eled momfluorothrin aerosol use, there is uncertainty regarding the toxicity of momfluorothrin to terrestrial plants . H owever, since uniform coverage of foliar surfaces is not expected from the proposed uses, and since momfluorothrin is not a systemic compound, adverse phytotoxic response, if observed, is expected to be localized on individual plants and spatially limited in plant communities

. 

### 5.4 Ecological Risk

In its qualitative assessment, EPA identified risks of concern by estimating the amount of active ingredient (i.e., number of cans of formulated product) that would need to reach a water body to result in risk to non

- target organisms, and considering the likelihood of such hypothetical exposures occurring , based on the proposed use patterns and labeling

. C omparisons of toxicity to exposure are included as part of the risk description.

5.4.1 A quatic Organisms

EPA evaluated risk to aquatic systems by dividing system s into two general c ompartments: the water column (the aquatic area between surface and the benthos ), and the benthos (sediments and

an area extending approximately 6 inches above the sediment)

. Aquatic risk predictions for fish and aquatic invertebrates are low due to the nature of the proposed u ses and aerosol form. A dverse effects to aquatic plants are not expected.

5.4.1.1 Water Column
Momfluorothrin is very highly toxic to freshwater fish (surrogate species for aquatic

- phase amphibians) and aquatic invertebrates on an acute exposure basis

. Assuming a standard farm pond of 20 million liter s , acute listed species LOCs would be exceeded for freshwater fish and freshwater invertebrates following release of approximately 2 and 15 aerosol cans of product
, respectively. T his particular exposure sce nario would qualify as product misuse
, as direct application to or near water is prohibited
, and is thus unlikely to be realized in the environment

. On a chronic basis, freshwater invertebrate growth and reproduction were found to be adversely affected i n the toxicity studies , but the exposure concentrations that would result in RQs exceeding the chronic LOCs for freshwater fish and invertebrates are very high; it would take between 20

- 100 cans in the standard farm pond to reach that threshold.

No acute or chronic toxicity data for estuarine/marine organisms were submitted, but considering the proposed use patterns and anticipated dilution of the product prior to it reaching

e stuarine/marine habitat areas
, risk to estuarine/marine organisms is expected to be low

. 5.4.1.2 Benthos ( Sediment )

In the absence of a definitive no

- effect concentration for chronic testing with the midge, it is not possible to confidently identify the threshold of toxicological significance. Compounding the risk uncertainty, the magnit ude of exposure that might reasonably be expected to result from use is undefined. Pyrethroids as a class tend to partition to sediments, and tend to be very highly toxic

Page 12 of 20to benthic invertebrates; however, the Koc values for momfluorothrin are much lower t han Koc values for other pyrethroids. While populations of benthic aquatic invertebrates may be adversely affected by drift or runoff, EPA expects the extent of these impacts to be reduced by the spatially

- limited nature of the proposed application use pat terns, and the low amount of momfluorothrin in the proposed products.

5.4.1.3 Aquatic Plants

I t would take over 300 cans being applied/released directly into the modeled pond before EECs would exceed the listed species LOC for aquatic vascular and nonvascular plants. Thus, potential risk to aquatic plants from the proposed uses of momfluorothrin is considered to be low.

5.4.2 Terrestrial Organisms
Adverse acute and chronic effects to birds (surrogate species for terrestrial

- phase amphibians and reptiles) and mamma ls are not expected; neither are effects to terrestrial plants expected. While available toxicity data indicate that adverse effects to individual non

- target insects are likely to result from exposure, exposure is expected to be spatially and temporally li mited. Thus, direct adverse effects to terrestrial invertebrates are not expected.

5.4.2.1 Mammals

Acute risk to mammals is considered to be low. The available acute mammalian dose

- based toxicity study did not determine a median lethal dose

. Momfluorothrin is categorized as practically nontoxic to mammals on an acute basis
, and dietary exposure to momfluoroth r in

treated food items from spray drift or large quantities of dispersed product is unlikely

.
Chronic risk to mammals is also considered to be low. A chronic mammalian dietary study determined a NOAEL of 200 mg a.i./kg

- diet. In order to exceed the chronic LOC of 1 on a dietary

- or dose

- basis , the application rate would have to be greater than 0.8 lbs a.i./acre. An entire 7 ounce (201 g) aerosol spray c an containing 0.1% a.i. momfluorothrin, if uniformly distributed over a 200 square foot area, would equate to an application rate of 0.09 lb a.i./A. Considering the same size foraging area, approximately 9 cans of product would need to be applied for risk quotients (RQs) to exceed the chronic LOC.

5.4.2.2 Birds
Momfluorothrin is categorized as practically non

- toxic to mallard duck, bobwhite quail, and zebra finch on an acute and subacute oral and dietary basis. Dietary exposure to food items containing momfluorot h r in

- residues from spray drift or large quantities of dispersed product is unlikely, and acute risk to avian species (surrogate species for terrestrial

- phase amphibians and reptiles) is expected to be low.
Chronic risk to avian species is also expected to be low. Chronic avian reproduction testing with northern bobwhite quail found effect s at all concentrations tested. Since a NOAEC was not determined, it is not possible to define a threshold at which the ex posure would not result in risk exceeding the level of concern. However, since the upper bound estimates for short grass would be approximately 21 ppm for a scenario involving uniform distribution of an entire can’s

Page 13 of 20contents over a 200 square foot area, an d since 21 ppm is approximately an order of magnitude less than the lowest dose tested in the bobwhite avian reproduction study, there is a good margin of safety . Furthermore, pyrethroids as a class are not known to have chronic avian toxicity

concerns.
5.4.2.3 Terrestrial Invertebrates
While available toxicity data indicate that adverse effects to individual non

- target insects are likely to result from exposure, exposure is expected to be spatially and temporally limited. Thus,

a cute and chronic risk to non

- target terrestrial invertebrates is considered unlikely

. 5.4.2.4 Terrestrial Plants
Risk to terrestrial plants resulting from the proposed aeros ol spray uses remain uncertain. H owever, since uniform coverage of foliar surfaces is not expected from the proposed aerosol uses, and since momfluorothrin is not a systemic compound, adverse phytotoxic response, if observed, is expected to be localized on individual plants and spatially limited in plant communities. Additional data regarding the toxicity of momfluorothrin to terrestrial plants would not likely impact the risk conclusions of the Agency’s risk assessment; however, additional terrestrial plant toxicity testing would be neede d to assess the risk to plants from any future broadcast use of momfluorothrin.



### 5.5 Endangered Species Act Considerations

Results from EPA’s screening

- level ecological risk assessment indicate that the proposed uses of momfluorothrin are unlikely to result i n direct or indirect adverse effects to listed species of any taxon. Thus, a “no effect” determination is made.
The NAS report, available at http://www.nap.edu/catalog.php?record_id=18344
, outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that are compliant with the Endangered Species Act and the Federal Insecticide, Fungicide, and Rodenticide Act. In November, the EPA, along with the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (collectively, the Services), and the U.S. Department of Agriculture (USDA), released a summary of their joint Interim Approaches for assessing risks t o listed species from pesticides. The Interim Approaches were developed jointly by the Agencies in response to the NAS’s recommendations and reflect a common approach to risk assessment shared by the Agencies as a way of addressing scientific differences b etween EPA and the Services. The joint Interim Approaches were released prior to the stakeholder workshop held on November 15, 2013. EPA presented the joint Interim Approaches at the December 2013 PPDC ( Pesticide Program Dialogue Committee) and SFIREG (Sta te FIFRA Issues Research and Evaluation Group) meetings, allowing additional opportunities for stakeholders to comment on the Interim Approaches . As discussed at the November 2013 workshop, and consistent with the March 2013 stakeholder engagement process for FIFRA

- ESA consultations, the Agencies have invited comment on the Interim Approaches as preparations are made to apply these new approaches in the context of upcoming registration review decisions. The Agencies intend to jointly implement these approac hes as part of a phased iterative process that takes account of the input received and the lessons learned from the initial efforts to work with the Interim Approaches.

Page 14 of 20I t is important to understand that the development of the Interim Approaches does no t by its terms suggest that existing or recently developed risk assessments using the criteria articulated in OPP’s 2004 Overview document are necessarily “under

- protective.” The Interim Approaches are intended to identify interim thresholds for interagency review as the Agencies jointly work to implement the recommendations of the NAS on certain specific registration review action s. The Agencies have made no determination that these thresholds are necessary to prevent take and preclude likely jeopardy and, in any case, the Interim Approaches do not establish legally binding thresholds for consultation under the Services’ implement ing regulations. As EPA and the Services work through the initial actions that are being reviewed under the Interim Approaches, the Agencies will determine whether these thresholds should be modified before they are extended more broadly to additional regulatory actions. T he details of the joint Interim Approaches are contained in the white paper “Interim Approaches for National- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013, available at http://www.epa.gov/espp/2013/nas.html

.



### 6 Benefits and Alternatives

EPA r eceived and ev aluated product- specific performance data on t he pr oposed end- use formulations, and de termined tha t m omfluorothrin i s ef ficacious a gainst

s everal pe sts of publ ic health concern, including flies, mosquitoes, wasps, hornets
, yellow j ackets, roaches, ticks, bed bugs, scorpions, centipedes, and certain species of ants a nd spiders. P ublic he alth pests may

cause pa inful bi tes a nd stings, allergic r eactions, transmission of di sease ( e.g., West N ile vi rus, Lyme disease), and even death. The Agency considers products that control these pests to be beneficial to the public. Th e end -use products are cla ssified as a cute toxicity categ or ies III a n d IV for a ll routes of exposure and bear the “Caution” signal word.

C onsistent with its mode of action, momfluorothrin is toxic to fish, aquatic invertebrates, and terrestrial invertebrates. However
, across these taxa momfluorothrin has a comparable

— or in some cases, lower

— ecological hazard profile relative to alternative registered products with similar use patterns , including other synthetic pyrethroids (bifenthrin, permeth rin, tetramethrin), pyrethr ins, and the neonicotinoid imidacloprid (See Table 2)

.
C ompared to bifenthrin and permethrin, momfluorothrin is less toxic to fish, aquatic invertebrates, and terrestrial vertebrates. Compared to pyrethrins, it is less toxic to aquatic and terrestrial in vertebrates. Although momfluorothrin is more toxic to fish than imidacloprid, exposure to fish, as discussed above, is expected to be low based on the labeled use patterns and prohibitions against application near bodies of water. Toxicity to fish and terr estrial invertebrates is comparable with tetramethrin.

P age 15 of 20Table 2. Ecological Hazard Comparison of Momfluorothrin Alternatives

Momfluorothrin Bifenthrin Imidacloprid Permethrin Pyrethrin Tetramethrin

Acute Fish 1.2 μg a.i./L 0.15 μg a.i./L > 83,000 μg/L 0.79 μg a.i./L 5.1 μg a.i./L 3.7 μg a.i./L

Chronic Fish 3.1 μg a.i./L 0.04 μg a.i./L 1,200 μg/L 0.0515 μg a.i./L 1.9 μg a.i./L No data

Acute aquatic invertebrates 7.8 μg a.i./L 0.004 μg a.i./L 37 μg/L 0.018 μg a.i./L 0.14 μg a.i./L No data

Chronic aquatic invertebrates 1.8 μg a.i./L pore water 0.0013 μg a.i./L 0.6 μg/L 0.011 μg a.i./L 0.86 μg a.i./L No data

Terrestrial invertebrates Contact LD50 = 0.2 μg a.i./bee 0.015 μg/bee 0.078 μg/bee (contact) 0.024 μg a.i./bee (contact) 0.022 μg a.i./bee (contact) 0.155 μg/bee (contact)

Note: No toxicity data available for terrestrial plant hazard comparison

Considerably less toxic compared to momfluorothrin Toxicity comparable to momfluorothrin Considerably more toxic than momfluorothrin



### 7 Regulatory Decision

Under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Agency is un conditional ly regist er ing pesticide products containing the new active ingredient momfluorothrin for use in indoor and outdoor residential a nd commercial settings

. The products

are summarized below

.
10308

- GL ( SUMIFREEZETM Manufacturing Use Product)

• 15.7% momfluorothrin

• MUP
, for formulation into direct spray products for non

- food indoor and outdoor residential

use

10308

- GA (S

- 1563 Flying and Crawling Insect Killer Spray)

• 0.1% momfluorothrin, 0.2% d

- phenothrin

• Indoor and outdoor spot and crack and crevice applications

• Pests include: flies, mosquitoes, wasps, hornets, yellow jackets, ants, roaches, spiders

1021

- EANR (MGK 2981)

• 7% momfluorothrin, 14% cypermethrin

• MUP, for formulation into insecticide products for indoor and outdoor residential use

1021

- EANE (MGK 2983)

• 2.225% momfluorothrin, 17.800% PBO

• MUP, for formulation into products for indoor and outdoor residential use

Page 16 of 201021

- EANG (MGK 2987)

• 5% momfluorothrin, 20% d

- phenothrin

• MUP, for formulation into direct spray products

1021

- EANU (MGK 29811)

• 0.025% momfluorothrin, 0.05% cypermethrin

• Indoor residential use, spot, crack and crevice, bedframes, mattress and furniture tufts a nd

seams , livestock housing (non

- food)

• Pests include: ants, Asian lady beetles, bed bugs, spiders, boxelder bugs, ticks, carpet beetles, American cockroaches, crickets, fleas, scorpions, silverfish, sowbugs

1021

- EANL (MGK 29831)

• 0.05% momfluorothrin, 0.4% PBO

• Indoor and outdoor spot and crack and crevice applications

• Pests include: flies, mosquitoes, moths

1021

- EANA (MGK 2987 1 )

• 0.05% momfluorothrin, 0.2% d

- phenothrin

• Indoor and outdoor spot and crack and crevice applications

• Pests include: wasps, horn ets, yellow jackets, scorpions

1021

- EANT (MGK 2987 2 )

• 0.05% momfluorothrin, 0.2% d

- phenothrin

• Indoor and outdoor spot and crack and crevice applications

• Pests include: wasps, hornets, yellow jackets, scorpions



### 7.1 Public Comments

On October 30, 2013 , EPA published in the Federal Register a Notice of Receipt of an application to regist er momfluorothrin
, and opened a public comment period of 30 days. Two comments were received: one from the San Francisco Bay Regional Water Quality Control Board (SFB RWQCB) ; one from the California Stormwater Quality Associa tion (C A SQA). The comments were similar in requesting that EPA conduct a full evaluation of the potential for momfluorothrin products to cause adverse impacts in the water colum n and sediment in urban water s. EPA responded to the comments in the document, “ Proposed Registration of the New Active Ingredient Momfluorothrin,” available in the docket EPA

- HQ

- OPP

- 2013

- 0478.

On December 19, 2014, EPA announced the proposed decision to grant an unconditional registration for momfluorothrin, and held a public comment period for 30 days, closing on January 18, 2015 at 11:59pm. C omments were received from two interested parties : Sumitomo Chemical Company , and the Center for Biological Diversity

. The comments are available in the docket EPA

- HQ

- OPP

- 2013

- 0478

.

Page 17 of 20Sumitomo Chemical Company (SCC) Comments
SCC provided comments on EPA’s risk assessments for momfluorothrin . The comments on the human health risk assessment comprise editorial/typographical corrections; the comments on the environmental fate and ecological risk assessment pertain to data acceptability and editorial/typographical corrections. EPA appreciates th ese comments from SCC, and its response s are detailed in separate document s , available in the docket EPA

- HQ

- OPP

- 2013

- 0478

. Center for Biological Diversity (CBD) Comments

CBD provided comments on the endangered species consultation process for future use expansions and “other ingredients” in momfluorothrin pesticide formulations, and additionally proposed advisory language to address theoretical risks to threatened and endangered species that could result from product misuse

. EPA thanks CBD for these comm ents, and not es that CBD concurs with the “ no effect ” determination for the currently proposed uses of momfluorothrin

. Ex c erpts from CBD’s comments and EPA’s responses are provided below:

CBD:

...EPA must consult with the Services regarding the registratio n of any new end

- use and manufacturing

- use products, which are proposed by the registrant subsequent to the registration of Momfluorothrin, that “may affect” endangered species...

... the EPA must consider “other ingredients” within a pesticide end product wh ere those ingredients “may affect” listed species even if they are less toxic than the active ingredient being reviewed... EPA must consider the potential impacts of “other ingredients” as part of any future consultation process on Momfluorothrin product.

E PA Response:
EPA is currently focusing most of its resources for assessing impacts to listed species on its registration review program for currently registered pesticides. EPA will continue to work towards prioritizing its consultation activities with th e Services, and will evaluate the appropriate timing and scope of consultation on momfluorothrin in connection with those efforts. To the extent that EPA receives applications for new uses, or other new information indicating that momfluorothrin or other i ngredients may pose a greater risk to listed species than previously indicated, EPA will evaluate the terms of registration and determine whether additional use restrictions to protect listed species are necessary. In conducting its ecological risk assessm ents, EPA does review toxicity data conducted on ty pical end

- use formulations, which include “other ingredients

. ” Any internal or interagency review will continue to rely on the body of information used in the current ecological assessment.

CBD:

The Center recommends that the EPA develop educational, advisory language for all Momfluorothrin labels which notes that this pesticide active ingredient theoretically poses a risk to endangered species if it is misused, just as the EPA routinely includes generic

Page 18 of 20acvisory language to protect non

- listed species... The following advisory information, or something similar in message, should be required for all Momfluorothrin labels: “This product may be hazardous to endangered species, and is likely toxic to be toxic to endangered fish, endangered aquatic invertebrates, and endangered terrestrial invertebrates. Do not use this product in areas known to be occupied by endangered species or in the critical habitat of endangered species.”

EPA Response:

As noted ab ove, EPA has made and CBD has concurred with a “no effects” determination for the currently proposed uses of momfluorothrin

— in other words, the proposed uses are
un likely to overlap with the habitats of threatened and endangered species. Consequently
, EPA believes that the currently proposed label statements (discussed in section 7.4 below) adequately mitigate potential risks to non

- target species that may result from labeled product

use s

. As the proposed end

- use products are formulated as ready

- to

- use aero sols for indoor and limited outdoor use, EPA further believes that that the addition al labeling statements related to endangered species are unlikely to have practical value for residential and commercial end

- users of the products, who may not be aware of where endangered species and their critical habitats are located.

EPA will consider CBD’s proposed language along with other appropriate label statements to address risks to threatened and endangered species , should there be future expansions of the use patterns for momfluorothrin that result in an a “may affect” determination.



### 7.2 Regulatory Rationale

There are no human health risks of concern from the proposed uses of momfluorothrin in indoor and outdoor residential and commercial settings. Estimates of both residential and occupational handler and post

- application risk are well below EPA’s level of concern. Furthermore, as the proposed uses are non

- food uses
, limited in scope , there will be no exposure to momfluorothrin through food or drinking water.
Results from a screening

- level ecological risk a ssessment indicate low potential for risks to non

target organisms. Momfluorothrin is considered practically non

- toxic to birds and mammals. Although m omfluoro thrin is classified as highly toxic to fish, aquatic invertebrates, and terrestrial invertebrates, predicted exposures from ready

- to

- use aerosol formulations are expected to be spatially restricted to small areas. To mitigate potential exposure to smaller water bodies in close proximity to treated areas, outdoor applications are limited to spot and crack

- and

- crevice treatments, and product labels prohibit application within 25 feet of water. To reduce risk to pollinators, application is prohibited if bees a re foraging in treatment areas

. Momfluorothrin is efficacious against several pests of public health concern, including flies, mosquitoes, wasps, hornets, yellow jackets, roaches, ticks, bed bugs, scorpions, centipedes, and certain species of ants and spi ders. Public health pests may cause painful bites and stings, allergic reactions , transmission of disease (e.g., West Nile virus, Lyme disease), and even death. The Agency considers products that control these pests to be in the public’s interest.

Page 19 of 20

### 7.3 Data R equirements

There are no outs tanding data requirements at this time for momfluorothrin. Outdoor use expansions including broadcast applications would trigger additional data requirements.



### 7.4 Mitigation and Labeling Requirements

In order to mitigate potential risk s to fish, aquatic invertebrates, and terrestrial invertebrates , the applicant s have agreed to add the following labeling language , which is intended to reduce the area of potential exposure to momfluorothrin residues by reducing inadvertent off

- target exposure via drift and runoff:

• This pesticide is highly toxic to fish and aquatic invertebrates. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.

• To protect the environment, do not allow pesticide to en ter or run off into storm drains, drainage ditches, gutters or surface waters. Applying this product in calm weather when rain is not predicted for the next 24 hours will help to ensure that wind or rain does not blow or wash pesticide off the treatment ar ea.



### • This product is highly toxic to bees exposed to direct treatment on plants or weeds. Do not apply this product while bees are foraging

. Do not apply this product to plants that are flowering. Only apply after all flower petals have fallen off.

• All outdoor applications must be limited to crack

- and

- crevice or spot surface treatments only. All outdoor applications to impervious surfaces such as sidewalks, driveways, patios, porches and structural surfaces (such as windows, doors and eaves) are limited to spot and crack

- and

crevice applications only.

• Do not apply to directly to water. Do not apply within 25 feet of lakes, streams, ponds, estuaries, oceans or other waters.

Page 20 of 20