UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

PC Code: 016331

DP Barcode: 410075

December 4, 2014

MEMORANDUM

SUBJECT: Environmental Fate and Ecological Risk Assessment for the Section 3 New

Chemical Registration of the Pyrethroid Insecticide Momfluorothrin

TO:

FROM:

Through: Julie Chao, Risk Manager Reviewer

Kable Davis, Product Manager Team 25

Insecticide/Rodenticide Branch

Registration Division (7505P) 

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Ibrahim Abdel-Saheb, Ph.D., Environmental Scientist 

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Mark Corbin, Branch Chief 

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Monica Wait, Risk Assessment Process Leader <./' 

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The Environmental Fate and Effects Division (EFED) has completed the screening level

assessment of the environmental fate and ecological risks ofthe proposed new chemical

momfluorothrin (PC Code 016331 ). This assessment is for a national registration of aerosol

spray can products intended for residential spot and crack and crevice treatments, or wasp and

hornet nest treatments. The following are considered target pests: flying insects (e.g., flies, mosquitoes, and gnats), stinging insects (e.g., hornets, wasps, yellow jackets, and mud daubers), spiders, and crawling insects (e.g., roaches, ants, centipedes, scorpions, and sowbugs).

While ecotoxicity data gaps exisit, the environmental fate and ecotoxicity databases are sufficient for assessing the risk associated with the proposed aerosol spray can uses. Expansion- Page 2 of 62

-

of the proposed momfluorothrin use pattern to include broadcast applications (e.g., agricultural or mosquito adulticide uses) will require additional environmental fate and ecological effects data to support those uses.

Summary of Risk Conclusions

The results of this screening

- level assessment on the proposed momfluorothrin uses indicate low potential risk for non

- target aquatic animal s and terrestrial invertebrate s based on risk lev el of

concern exceedances

. A quatic risk predictions for fish and aquatic invertebrates are low under EFED’s standard exposure scenario due to the nature of the proposed uses and aerosol

formulations. While much smaller water bodies in close proximity to treated areas may have

increase d vulnerability due to the highly toxic nature of the product , the requisite exposure to reach risk levels of concern is unlikely considering that direct application to water is prohibited and runoff is mitigated by the label s’ restriction regarding applications near surface water ( i.e.

, the 25 foot buffer)

. Results of this screening

- level ecological risk assessment indicate that the proposed uses of momfluorothrin are unlikely to result in direct adverse effects to listed sp ecies of any taxon. Since direct effects are not predicted, indirect effects are not expected to result from the proposed uses of momfluorothrin.

For the drinking water assessment, EFED believes based on the use pattern (i.e. ready

- to

- use spray cans), while some outdoor exposure is possible, it is unlikely the use will yield aquatic exposures that will impact drinking water. For that reason, no quantitative drinking water assessment (DWA) has been conducted for these products and this use pattern. EFED believes that this evaluation is consistent with previous assessments for this particular outdoor use pattern for other pesticides. Should the registrant amend or add to this use pattern, EFED will reconsider the need for a DWA depending on the nature of t he changes (DP Barcode: 410074; 02/12/2014).

Uncertainties

Ecotoxicological data gaps exist for avian repro duction toxicity

, avian acute oral toxicity (passerine species), benthic invertebrate chronic toxicity, estuarine/marine acute and chronic

animal t oxicity, aquatic nonvascular plant toxicity, and terrestrial plant toxicity

. While ecotoxicity data gaps exisit, available ecological effects data are sufficient for assessing the risk associated with the proposed aerosol spray can use because the predicted exposure s are expected to be spatially restricted to small areas

.

Recommended Label Amendment s

Based on the available toxicity data, momfluorothrin product label s should state that

m omfluorothrin is toxic to fish, aquatic invertebrates and terrestrial invertebrates where applicable ( e.g. , labels for outdoor use ) ; however, some of the proposed labels do not include this language and each of the proposed momfluorothrin labels has a uniq ue Environmental Hazards

section. Each momfluorothrin product label registered for outdoor use should share a consistent

environmental hazard statement. The following generic environmental hazard statement s are suggested for placement on each momfluoroth rin product label being considered for outdoor use:- Page 3 of 62

-

“ To protect the environment, do not allow pesticide to enter 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 area.”

“This pesticide is toxic to fish and aquatic invertebrates.”

“Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated

areas”

“ This product is highly toxic to bees exposed to direct treatment on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds while bees are actively visiting the area

. ”

The following Environmental Hazard statements appear on the proposed product label s :

10308

- GA

 This product is toxic to fish, and to bees exposed to direct treatment. Do not apply this product while bees are actively visiting the treatment area. Do not apply directly to water.

MGK

- 29811 (For indoor residential use only)

 This pesticide is extremely toxic to fish and aquatic invertebrates. Do not apply directly

to or near w ater.

MGK

- 29831

 This pesticide is toxic to environmental organisms, including fish and invertebrates. Do not apply directly to or near water. Drift and run

- off may be hazardous to fish in water adjacent to treated areas.

MGK

- 29871

 This product is highly toxic to fish and other aquatic invertebrates. Do not apply directly

to water. Drift and runoff may be hazardous to aquatic organisms in water adjacent to

treated areas.

MGK

- 29872

 This pesticide is extremely toxic to aquatic organisms, including fish and aquatic invertebrates. Do not apply directly to water. Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas. Applying this product in calm weather when rain is not predicted for the next 24 hours will help to ensure th at wind or rain does no blow or wash pesticide off the treatment area. This product is highly toxic to bees exposed to direct treatment on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds while bees are act ively visiting the area.

The current Sumitomo S

- 1563 Flying and Crawling Insect Killer Spray (EPA Reg no. 10308

-- Page 4 of 62

-

GA) label prohibits use within 25 feet of saltwater. This use restriction should be modified to include freshwater areas because of its high toxicity to aquatic organisms and to be consistent with other pyrethroid product labels.

The MGK

- 29811 label states that it is intended for indoor residential use only. However, site use claims include outdoor areas. These discrepancies should be resol ved, but will not affect the ecological risk assessment conclusions since similar MGK products registered for outdoor use

were considered.

Label language should be consistent with the recommendations of EPA’s February 2013 guidance titled: “ Environmental Hazard and General Labeling for Pyrethroid and Synergized Pyrethrins No n

- Agricultural Outdoor Products,” available at: http://www.epa.gov/oppsrrd1/reevaluation/environmental

- hazard

- statment.html

Response to Comments

During the 30

- day public comment period on the Federal Register Notice announcing the receipt of the momfluorothrin registration application (78 FR 64937), t he Agency received two public comments regarding the evaluation of momfluorothrin for registration in the United States . One

commen t was from the California Stormwater Quality Association (CASQA)

, and the second

was from the San Francisco Bay Region al Water Quality Control Board (SFB RWQCB ). Both

comments are available in the docket at www.r egulations.gov , EPA

- HQ

- OPP

- 2013

- 0478,

comments

- 0002 and

- 0003. Parts of both comments were similar in requesting that EPA conduct a full evaluation of the potential for momfluorothrin products to cause adverse impacts in the

water column and sediment in u rban waters. Excerpts from the submitted comments and EPA’s responses are provided below.

CASQA and SFB RWQCB:

We request that U.S. EPA carefully evaluate all momfluorothrin product registration applications. Specifically, we request a full evaluation of the potential for momfluorothrin products to cause adverse impacts in the water column and sediment in urban waters. We request that U.S. EPA consider all urban application locations and evaluate potential pathways to receiving waters under conditions c onsistent with label instructions. The evaluation should include any stable degradates and the time required for the active ingredient and degradates to become non

- toxic. If momfluorothrin use consistent with label instructions can result in toxicity in re ceiving waters, further restrictions on use (such as modified label instructions or limitations on the types of retail products sold) must be evaluated. We encourage U.S. EPA to pay special attention to application types

— like control of insects around buil dings and preconstruction termiticide applications

— that are being addressed in U.S. EPA’s pyrethroids registration reviews, such as the bifenthrin review. We suggest that U.S. EPA’s workplan for reviewing this registration application and the data requirem ents for momfluorothrin registration be comparable to the workplans and data requirements for the pyrethroids undergoing registration review.- Page 5 of 62

-

EPA Response:

EPA appreciates the comments provided by the California Stormwater Quality Association and

the San Francisco Bay Regional Water Quality Control Board regarding the proposed registration of momfluorothrin.

EPA recognizes that pyrethroid insecticides have created issues with sediment toxicity, especially in urban areas, as a results of runoff from use s ites and discharge from sewage treatment plants. Data for Chironomus dilutus do indicate that momfluorothrin is toxic to benthic invertebrates (49

- day NOAEC for growth and reproduction is less than 13 micrograms per kilogram sediment , or 1.8 μg/L pore wat er ).

The proposed uses of momfluorothrin, which include only indoor and outdoor spray cans to kill flying insects, are unlikely to result in sufficient usage to contribute to sediment burdens of pyrethroids. None of the proposed uses is believed to res ult in a down

- the

- drain type exposure,

thus POTW effluent and biosolids issues are not believed to be of concern.

In the event that momfluorothrin is transported to a waterway, its exceptionally low partition coefficients (K oc = 1033 to 4344 L/kg o.c.) and log K ow (2.88) indicate that it is much less likely to partition to sediment than other pyrethroids currently on the market. Should momfluorothrin be transported to, and persist in sediment (which is considered unlikely), its effects would likely

be additive with those of other pyrethroids.

Momfluorothrin also degrades quickly, in comparison to other pyrethroids, by a number of processes, including alkaline hydrolysis, aqueous photolysis, and aerobic metabolism in soil and

water. Half

- lives are on t he order of a few days. Thus it is not persistent, like other pyrethroids, and is again less likely to contribute to chronic sediment toxicity. These fate properties also suggest that momfluorothrin would be degraded in a POTW.

SFB RWQCB

Consider cumu lative impacts

— Evaluate pesticide mixtures occurring in surface waters, such as mixtures with other pyrethroids, which commonly occur in surface waters. Mixtures could be a significant factor contributing to any potential toxic effects of momfluorothrin.

EPA Response :

A prospective (i.e., predictive) ecological risk assessment of pesticide mixtures would require a

substantial amount of information regarding the temporal and spatial extent of pesticide usage within a watershed, which is currently lacking. This informati on is needed to accurately predict (or screen) pesticide concentrations in a waterbody because different pesticides will be applied at different times and locations within any given watershed. In addition, a watershed

- based model

would also need to be dev eloped and reviewed for this particular application in order to capture the temporal and spatial dynamics of multiple pesticide uses and applications. Although a prospective cumulative ecological risk assessment methodology is subject to these and other

c hallenges related to exposure and effects assessment, the EPA believes that available- Page 6 of 62

-

monitoring data for pyrethroids do offer some potential to evaluate cumulative ecological risk in a retrospective manner. The Agency will consider monitoring data of pyr ethroid mixtures, such as concentrations in sediments, in the context of their potential to provide insight into ecological risks of pyrethroid mixtures to the extent that simplified assumptions regarding their combined toxicity (additivity) are scientific ally supported.

SFB RWQCB

Study effects on benthic biota

— Conduct sediment toxicity studies (with spiked sediment, rather than by adding momfluorothrin to the overlying water). Momfluorothrin is expected to deposit and persist in aquatic sediment.

EPA Response:

As discussed above, m omfluorothrin degrades quickly in comparison to other pyrethroids by a number of processes, including alkaline hydrolysis, aqueous photolysis, and aerobic metabolism

in soil and water. Half

- lives are on the order of a few days. Thus it is not persistent, like other pyrethroids, and is less likely to contribute to chronic sediment toxicity. Available chronic sediment toxicity testing with midge was conducted using spiked sediment.- Page 7 of 62

-



# Environmental Fate and Ecological Risk Assessment for the Registration of Momfluorothrin

M omfluorothrin 2,3,5,6

- tetrafluoro

- 4

- (methoxymethyl)benzyl (EZ)

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

- 3

- (2

-

cyanoprop

- 1

- enyl)

- 2,2

- dimethylcyclopropanecarboxylate CAS Registry Number : 609346

- 29

- 4
PC Code : 016331

Prepared by: Nathan Miller, Biologist

Ibrahim Abdel

- Saheb, Ph.D., Environmental Scientist

U. S. Environmental Protection Agency Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch IV 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington DC 20460 Reviewed by: Amy Blankinship

, Senior Biologist, ERB VI
William P. Eckel, Ph.D, Senior Science Advisor, ERB VI
Mark Corbin, Branch Chief, ERB VI

December 4 , 201 4- Page 8 of 62

-

Table of Contents

1. Executive Summary

................................ ................................ ................................ .............. 9

1.1. Nature of Chemical Stressor

................................ ................................ ................................ .................... 9

1.2. Potential Risks to Non

- target Organisms

................................ ................................ ............................... 9

1.3. Conclusions

- Exposure Characterization

................................ ................................ ............................ 10

1.4. Conclusions

- Effects Characterization

................................ ................................ ................................ . 10 2. Problem Formulation

................................ ................................ ................................ ......... 12

2.1. Nature of Regulatory Action

................................ ................................ ................................ .................. 12

2.2. Stressor Source and Distribution

................................ ................................ ................................ .......... 12

2.2.1. Nature of Chemical Stressor

................................ ................................ ................................ .............. 12

2.2.2. Overview of Pesticide Usage

................................ ................................ ................................ ............. 13

2.3. Receptors

................................ ................................ ................................ ................................ ................. 13

2.3.1. Aquatic and Terrestrial Effects

................................ ................................ ................................ .......... 13

2.3.2. Ecosystems Potentially at Risk

................................ ................................ ................................ .......... 14

2.4. Assessment Endpoints

................................ ................................ ................................ ............................ 14 2.5. Conceptual Model

................................ ................................ ................................ ................................ ... 14

2.5.1. Risk Hypotheses

................................ ................................ ................................ ................................ 14

2.5.2. Conceptual Diagram

................................ ................................ ................................ .......................... 15 2.6. Analysis Plan

................................ ................................ ................................ ................................ ........... 18

2. 6.1. Residues of Concern

................................ ................................ ................................ .......................... 18

2.6.2. Preliminary Identification of Data Gaps and Uncertainties

................................ ............................... 18

2.6.3. Evaluation of Multiple Active Ingredients and Mixtures

................................ ................................ .. 18

2.6.4. Measures of Exposure

................................ ................................ ................................ ....................... 18

2.6.5. Measures of Effect

................................ ................................ ................................ ............................. 19

2.6.6. Integration of Exposure and Effects

................................ ................................ ................................ .. 21 3. Analysis

................................ ................................ ................................ ............................. 22

3.1. Use Characterization

................................ ................................ ................................ .............................. 22

3.2. Exposure Characterization

................................ ................................ ................................ .................... 23

3.2.1. Environmental Fate and Transport Characterization

................................ ................................ ......... 23

3.2.2. Measures of Aquatic Exposure

................................ ................................ ................................ .......... 27

3.2.3. Measures of Terrestrial Exposure

................................ ................................ ................................ ...... 27

3.3. Ecological Effects Characterization

................................ ................................ ................................ ...... 28

3.3.1. Aquatic Toxicity Assessment

................................ ................................ ................................ ............ 28

3.3.2 Terrestrial Effects Characterization

................................ ................................ ................................ ... 31 4. Risk Characterization

................................ ................................ ................................ ......... 34

4.1. Risk Estimation

................................ ................................ ................................ ................................ ....... 34

4.2. Ris k Description

................................ ................................ ................................ ................................ ...... 34

4.2.1. Risk to Aquatic Organisms

................................ ................................ ................................ ................ 34

4.2.2. Risk to Terrestrial Organisms

................................ ................................ ................................ ............ 37

4.3. Uncertainties and Data Gaps

................................ ................................ ................................ ................. 40

4.3.2. Effects Uncertainties

................................ ................................ ................................ ......................... 40
5. Federally Threatened and Endangered (Listed) Species Concerns

............................... 41

5.1. Action Area

................................ ................................ ................................ ................................ ............. 41

5.2. Taxonomic Groups Potentially at Risk

................................ ................................ ................................ . 42
5.2.1. Probit Dose

- Response Analysis

................................ ................................ ................................ ...... 43
6. References

................................ ................................ ................................ ............................ 44

6.1. Submitted Environmental Fate and Transport Studies

................................ ................................ ..... 45

6.2. Submitted Ecotoxicity Studies

................................ ................................ ................................ .............. 47 Appendix A. Sumary of Environmental Fate Data for Momfluorot hrin

.............................. 51 Appendix B. Sumary of Ecological Effects Data for Momfluorothrin

................................ .. 54 Appendix C. Model Outputs

................................ ................................ ................................ ...... 59- Page 9 of 62

-

1. Executive Summary

1.1. Nature of Chemical Stressor

Sumitomo Chemical Company is seeking registration for the new chemical insecticide

M omfluorothrin ( 2,3,5,6

- tetrafluoro

- 4

- ( methoxymethyl)benzyl (EZ)

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

- 3

- (2

-
cyanoprop

- 1

- enyl)

- 2,2

- dimethylcyclopropanecarboxylate) ; CAS#: 609346

- 29

- 4 ; PC code:

016331 ). Momfluorothrin is new synthetic pyrethroid insecticide that is proposed for use to
control a wide range of insects and other arthropods.

Momfluorothrin , like other pyrethroids, is considered an axonic poison that prevents sodium channels in an organism’s neuronal membranes from closing, resulting in paralysis.

Momfluorothrin consists of 8 isomers, but is composed primarily of the RTZ (approximately 90%) and RTE isomers (approximately 10%). The minimum R isomer ratio is 0.98, the minimum Z isomer ratio is 0.90, and the minimum trans isomer ratio is 0.99 (Habig, 2012)

.

This assessment is for a national registration request for non

- agricultural, non

- food use control of the following target pests : flying insects (flies, mosquitoes, gnats), stinging insects (hornets, wasps, yellow jackets, mud daubers), spiders, and crawling insects (roaches, ants, centipedes, sowbugs

, and scorpions ). The proposed uses of momfluorothrin include indoor uses and limited outdoor uses. Indoor uses are proposed against several types of flying and crawling household
pests. Proposed outdoor uses include several types of stinging insects , flies , and crawling pests. Application method for both indoor and outdoor uses is only through the use of a hand

- held

aerosol can.

According to a risk assessment prepared by Cliff Habig of Compliance Services International (Habig, 2012), p roduct spray release rates for flying inse ct killers (FIKs) are generally approximately 1 g product/sec, while the product release rate for crawling insect killers (CIKs)

are typically approximately 3 g product/second. The second major type of product containing

momfluorothrin is the wasp and hornet killer (W+H), which contains momfluorothrin at a concentration of 0.05% w/w. This is also marketed in spray cans containing approximately 500 g

end

- use product. The release rate for W+H products is higher than those for FIKs or CIKs . W+H products generally release a jet spray of product at 20 g /second; this spray typically travels about 20 feet to its target, reducing the possibility of the applicator being stung. FIKs, CIKs, and W+ H
formulations will also contain either a second a ctive ingredient, such as phenothrin or cypermethrin; or a synergist, such as piperonyl butoxide ( PBO )

.

M ajor transformation products resulting from the environmental degradation of m omfluorothrin

are MFOA

- D and TFPA, Z

- CMCA and omega c

- CONH 2

- d

- t

- CRA , which degrades further to

CO 2

. No momfluor o thrin transformation products are considered in this risk assessment because they are not as toxic as the parent compound.

1.2. Potential Risks to Non

- target Organisms

Results of this screening

- level ecological risk assessment indicate that the proposed uses of- Page 10 of 62

-

momfluorothrin are unlikely to result in direct adverse effects to listed species of any taxon ( Table 1.1 ) , and a "no effect" determination is made

. Since direct effects are not predicted, indirect effects are not expected to result from the proposed uses of momfluorothrin.

Table 1.1. Potential Effects to Federally Listed Taxa Associated with Direct or Indirect Effects from the Proposed New Uses o f Momfluorothrin

.

Listed Taxon Direct Effects Indirect Effects

Terrestrial and semi

- aquatic plants

- monocots No No

Terrestrial and semi

- aquatic plants

- dicots No No

Birds No No

Terrestrial

- phase amphibians and reptiles No No

Mammals No No

Terrestrial invertebrates No No Aquatic nonvascular plants No No Aquatic vascular plants No No

Freshwater fish No No Aquatic

- phase amphibians No No

Freshwater crustaceans No No

Mollusks No No

Marine/estuarine fish No No

Marine/estuarine invertebrates No No

1.3. Conclusions

- Exposure Characterization

Momfluorothrin has low water solubility (approximately 0.9 mg/L at 20°C), low vapor pressure ( approximately 1.04 x 10

- 8 Torr at 2 5 °C), and a moderate log K ow (approximately 2. 88 ).

Momfluorothrin is non

- persistent in the environment. It is stable to hydrolysis at pH 4 and 7, but undergoes hydrolysis at pH 9, with half

- lives of approximately 12 days at 20°C and 7 days at

25°C. Momfluorothrin is susceptible to photolysis in water, wit h a half

- life of approximately 13 days under continuous illumination, which is equivalent to a half

- life of approximately 32 U.S. solar days (at 40°N latitude). Momfluorothrin undergoes rapid microbial degradation under aerobic conditions in soil, with ha lf

- lives less than 5 days, and in water

- sediment systems, with

half

- lives of less than 3 days. Momfluorothrin binds tightly to soil, with K oc s ranging from 1033

to 4344 for four different soils and one sediment.

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

- applied pesticides

. H owever, since the proposed momfluorothrin end

- use products are formulated as aerosol spray cans for localized uses and not for large scale broadcast applications and since the

momfluorothrin end

- use products do not have a maximum label rate, the exposure a ssessment for momfluorothrin is qualitative in nature.

1.4

. Conclusions

- Effects Characterization

For aer o sol spray applications of momfluorothrin

, no acute or chronic risks of concern are identified for aquatic animals on the basis of limited exposure

. Risk to aquatic vascular and- Page 11 of 62

-

nonvascular plants is not expected.

Acute and chronic risk to avian or mammalian species is not expected for aer o sol spray applications of momfluorothrin

. Risk to non

- target terrestrial invertebrates is considered low on the basis of limited exposure

.

While there is uncertain risk to terrestrial plants because of observed toxicity at one of the limit

doses tested , risk exceeding nontarget terrestrial plant levels of concern is not expected for the

pr oposed aerosol spray can use pattern

.- Page 12 of 62

-

2

. Problem Formulation

The purpose of problem formulation is to provide the foundation for the environmental fate and ecological risk assessment for the registration of the new chemical m omfluorothrin

, ( 2,3,5,6

- tetrafluoro

- 4

- ( methoxymethyl)benzyl (EZ)

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

- 3

- (2

- cyanoprop

- 1

- enyl)

- 2,2

- dimethylcyclopropanecarboxylate); CAS#: 609346

- 29

- 4 ; PC code: 016331 ). The problem

formulation sets the objectives for the risk assessment, establishes a risk hy pothesis and conceptual model depicting potential risk

, and provides a plan for analyzing the data and characterizing the risk associated with the proposed use of momfluorothrin ( USEPA, 1998 ).

2.1

. Nature of Regulatory Action

T he U.S

. Environmental Protection Agency (EPA or the Agency) is required under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to ensure that the newly proposed use of

m omfluorothrin as an insecticide does not have the potential to cause unreasonab le adverse

effects to the environment. In addition to non

- target animals and plants, potential effects to listed species ( i.e. , species on the Federal list of endangered and threatened wildlife and plants) and their designated critical habitat are also co nsidered under the Endangered Species Act (ESA)

in order to ensure that the registration of momfluorothrin is not likely to jeopardize the continued

existence of listed species or adversely modify their critical habitat. In order to meet the requirements of FIFRA and the ESA, this assessment follows EPA guidance on conducting ecological risk assessments ( USEPA, 1998 ) and Office of Pesticide Program’s Overview Document, which contains guidance for assessing pesticide risks to non

- target and listed organisms (USEPA, 2004)

.

The end result of the EPA pesticide registration process ( i.e. , the FIFRA regulatory action) is an approved ( or disapproved ) product label. The label is a legal document that stipulates how and where a given pesticide may be used. Produc t labels (also known as end

- use labels) describe the formulation type ( e.g. , liquid or granular), acceptable methods of application, approved use sites, and any restrictions on how applications may be conducted. Therefore, the use, or potential use,

descr ibed by the pesticide’s labels is considered “the action” being assessed. This assessment was prepared to support evaluation of the proposed new chemical registration of

m omfluorothrin.

2.2

. Stressor Source and Distribution

2.2. 1. Nature of Chemical Stressor

According to the technical registrant, Sumitomo Chemical Company

, momfluorothrin is a

knockdown pyrethroid insecticide (Habig, 2012)

. The pyrethroids (including momfluorothrin )

s hare a similar mode of action (MOA) , and are considered axonic poisons that affect both the peripheral and central nervous system. It is now well established that severe neurological symptoms of poisoning with pyrethroids in mammals and insects are the result of modification of sodium (Na + ) channel activity (cellular pores through which sodium ions are permitted to enter the axon to cause excitation) (Matsumura 1985).- Page 13 of 62

-

Five end

- use product formulations containing momfluorothrin were submitted with the new chemical package

. All proposed formulations are aerosol sprays intended for use in and around houses and buildings where the target pests may be found. The proposed uses for

momfluorothrin products fall under the indoor and residential /utility outdoor general use pattern
categ ories. All of the proposed formulations containing momfluorothrin have c oncentrations of

momfluorothrin in the range of 0.025% to 0.1% w/w. Product spray release rates for flying insect killers (FIKs ) are generally approximately 1 g product/sec, while the p roduct release rate for crawling insect killers ( CIKs) is typically approximately 3 g product/ second. The product release

rate for the wasp and hornet killer ( W+H ) product is 20 g product/second

.

2.2.2

. Overview of Pesticide Usage

Usage data are not available for momfluorothrin because it is a new active ingredient proposed

for use in the United States. M omfluorothrin is currently proposed exclusively for formulation

into hand

- held aerosol spray can s for residential /utility use by consumers.

2.3

. Receptors

2.3.1

. Aquatic and Terrestrial Effects

In ecological risk assessment, a receptor is a biological entity that is exposed to a stressor ( USEPA, 1998 ). Consistent with the process described in the Overview Document (USEP A

, 2004 ), this r isk assessment uses a surrogate species approach in its evaluation of

momfluorothrin . Toxic ity data generated using surrogate test species, which are intended to be representative of broad taxonomic groups, are used to infer potential ef fects on a variety of species (r eceptors) included under these broader taxonomic groupings. Table 2.1 provides the general taxonomic groups and surrogate species tested to evaluat e potential ecological effects of

momfluorothrin to broad classes of non

- target organ isms

. Within each of these taxonomic groups, a measure of effect is selected from among the available test data.

Table 2.1. Taxonomic Groups and Test Species Evaluated for Assessing Potential Ecological Effects of Momfluorothrin

.

Taxonomic Group Typical Species

Birds 1 Mallard duck ( Anas platyrhynchos ) Bobwhite quail ( Colinus virginianus )

Mammals Norway rat ( Ratus norvegicus )

In vertebrates Honey bee ( Apis mellifera L. )

Freshwater fish 2 Bluegill sunfish ( Lepomis macrochirus ) Rainbow trout ( Oncorhynchus mykiss ) Fathead minnow ( Pimephales promelas )

Freshwater invertebrates Water flea ( Daphnia magna ) Midge ( Chironomus riparius )

Estuarine/marine fish Sheepshead minnow ( Cyprinodon variegatus )

Estuarine/marine invertebrates Mysid ( Americamysis bahia ) Eastern oyster ( Crassostrea virginica ) Terrestrial plants 3 Monocots

– Crop species, such as corn ( Zea mays )

Dicots

– Crop Species, such as soybean ( Glycine max )- Page 14 of 62

-

Table 2.1. Taxonomic Groups and Test Species Evaluated for Assessing Potential Ecological Effects of Momfluorothrin

.

Taxonomic Group Typical Species Aquatic plants and algae 4 Duckweed ( Lemna gibba ) Freshwater Algae ( Pseudokirchneriell a subcapita ta )

1 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

2 Freshwater fish may be surrogates for aquatic

- phase amphibians.

3 Four species of two families of monocots, of which one is corn; six species of at least four dicot families, of which one is soybeans.

4 Four species of non

- vascular algae including a freshwater green algae, a cyanobacterium, a marine diatom, and a freshw ater diatom.

2.3. 2. Ecosystems Potentially at Risk

The ecosystems potentially at risk are often extensive in scope; therefore, it may not be possible to identify specific ecosystems during the development of a nation

- wide ecological risk assessment. However, in general terms, terrestrial ecosystems potentially at risk could include

the treated site and immediately adjacent areas th at may receive drift or runoff. For the proposed uses for momfluorothrin, a reas adjacent to the treated site could include gardens, residential landscaping, and property edges . Aquatic ecosystems potentially at risk include water bodies adjacent to or downstream from use site s, and might include impounded bodies such as ponds, lakes and reservoirs, or flowing waterways such as streams or rivers including all adjacent off

channel habitats that are permanently or intermittently connected to flowing waters . For uses in coastal areas, aquatic habitat also includes marine ecosystems, including estuaries, embayments,

and near

- shore environments such as tidal marshes

.

2.4

. Assessment Endpoints

Assessment endpoints represent the actual environmental value that is to be protected, defined by an ecological entity (species, community, or other entity) and its attribute or characteristics ( USEPA, 1998 ). For momflu orothrin , ecological entities of potential concern include the following: birds , amphibians, reptiles, mammals, freshwater fish and invertebrates, estuarine/marine fish and invertebrates, terrestrial plants, non

- target terrestrial invertebrates , and aquatic vascular and non

- vascular plants. The attributes for each of these entities may include growth, survival, and reproduction ( Table 2. 2 in Section 2.6. 4 ).

2.5 . Conceptual Model

For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological rece ptor. For an ecological pathway to be complete, it must have a source, a release mechanism, an environmental transport mechanism , and a feasible route of exposure.

The conceptual model is intended to provide a written description and visual representatio n of anticipated relationships between momfluorothrin

, potential routes of exposure, and the predicted effects for the assessment endpoint s

. The conceptual model consists of two major components: risk hypotheses and a conceptual diagram ( USEPA, 1998 ).

2.5. 1. Risk Hypotheses- Page 15 of 62

-

For momfluorothrin , the fol lowing generic ecological risk hypothes i s i s being employed for this screening

- level risk assessment:

Momfluorothrin , when used in accordance with registered labels, has the potential to

move off

- site via spray drift leading to exposure of nontarget plants and animals. Based on information on the environmental fate, mode of action, direct toxicity and potential indirect effects, EFED considers that the proposed uses of momfluorothrin ha ve the potential to cause reduce d survival, growth, and reproduction to non

- target terrestrial and aquatic animals and plants.

2.5.2

. C onceptual Diagram

The conceptual models for aquatic and terrestrial exposures are shown in F igure s 1 and 2

, respectively. For the currently registered uses, momfluorothrin is released into the air as suspended particles . For these uses, the active ingredient is initially present in the atmosphere in a volatile form but is expected to dissipate rapidly through a combination of degradation and dilution by the large volume of air into which it is released. Aquatic and ter restrial exposure occurs only after momfluorothrin has been deposited on land or water surfaces. In the conceptual models, d ashed lines denote exposure routes not assessed due to the low likelihood of

exposure

.- Page 16 of 62

-

Figure 1 . Conceptual model for momfluorothrin effects on aquatic organisms. 

## Stressor

Source

Receptors

Attribute Change Momfluorothrin applied as aerosol sprays

Drift

Aquatic animals

Invertebrates

Vertebrates

Individual organisms

Reduced survival Reduced growth Reduced reproduction 

### Food chain Reduction in algae and vascular plants

Reduction in prey

Modification of PCEs related to prey availability 

### Habitat integrity Reduction in primary productivity

Reduced cover Community change

Modification of PCEs related

to Habitat

habitat Surface water/

Sediment Runoff

Aquatic Animals

Invertebrates

Vertebrates 

## Exposure

Media

Uptake/gills

or integument

Ingestion Ingestion Atmospheric

transport

Wet/dry deposition Soil Leaching to

Groundwater

Uptake/gills
or integument

Aquatic Plants

Non

- vascular

Vascular 

### Uptake/cell,
roots, leaves Riparian plants

terrestrial exposure- Page 17 of 62

-

Figure 2 . Conceptual model for momfluorothrin effects on terrestrial organisms. 

## Stressor

Source

Attribute Change Momfluorothrin applied as aerosol sprays

Direct application 

### Drift

Terrestrial

vertebrates Terrestrial

Inverts



### Individual organisms

Reduced survival Reduced growth

Reduced reproduction Food chain

Reduction in prey and

food

Modification of PCEs related to prey availability Habitat integrity Reduction in primary productivity

Reduced cover Community change

Modification of PCEs related

to habitat Terrestrial plants grasses/forbs, fruit, seeds (trees, shrubs) 

### Runoff

Terrestrial

vertebrates 

## Exposure

Media & Receptors Soil

Ingestion Ingestion

Dermal uptake/Ingestion Atmospheric

transport

Root uptake/contact

Wet/dry deposition

Ingestion Leaching to

Groundwater 

### Irrigation

water- Page 18 of 62

-

2.6

. Analysis Plan

2.6.1

. Residues of Concern

No momfluorothrin transformation products are identified as residues of concern ; the exposure

assessment considers only the momfluorothrin parent compound

.

2.6.2. Preliminary Identification of Data Gaps and Uncertainties

T he submitted environmental fate and ecotoxicity data are sufficient to assess the risk associated with the aerosol spray can use ; however, any future submissions for new uses of momfluorothrin will prompt a re

- evaluation of the data n eeded for risk assessment

. Submitted momfluorothrin

environmental fate data are summarized in Appendix A

.

2.6. 3

. Evaluation of Multiple Active Ingredients and Mixtures

The Agency does not routinely include in its risk assessments an evaluation of mixtures of active ingredients, either those mixtures of multiple active ingredients in product formulations or those in the applicator’s tank. In the case of the product formulations of active ingredients (that is, a registered product containing more th an one active ingredient), each active ingredient is subject to an individual risk assessment for regulatory decision regarding the active ingredient on a particular use site. If effects data are available for a formulated product containing more than

one active ingredient, they may be used qualitatively or quantitatively in accordance with the Agency’s Overview Document and the Services’ Evaluation Memorandum (U.S. EPA 2004; U.S. FWS/NMFS 2004). T he re are four proposed end

- use product s for the new chemic al

momfluorothrin (for outdoor use); three products contain d

- phenothrin and one product contains

PBO

.

2.6. 4

. Measures of Exposure

Measures of exposure for pesticide risk assessments are typically based on aquatic and terrestrial

models that estimate environmental concentrations of pesticides using labeled application rates

and methods for broadcast

- applied pesticides

. However, since the proposed momfluorothrin

end

- use products are formulated as ae rosol spray cans for localized uses and not for large scale broadcast applications ( e.g. agricultural or mosquito adulticide use) and since the

momfluorothrin end

- use products do not have a maximum label rate, the exposure assessment for

momflourothrin is qualitative in nature.

For aquatic exposure estimates, i nstead of using approaches designed for broadcast applications

, for momflourothrin EFED estimates the amount of active ingredient that would have to reach a water body to result in risk to non

- targe t aquatic organisms and qualitatively discusses the likelihood that this might happen.

Terrestrial exposure estimates for avian and mammalian risk assessments were derived us ing the Terrestrial Residue EXposure model (T

- REX) (version 1.5

, 03 / 22 / 2012 ). The assumption of the- Page 19 of 62

-

model is that mammals and birds (surrogates for terrestrial

- phase amphibians and reptiles) may be exposed via their consumption of treated food items contaminated by direct spray or spray

drift as a result of application.

The S creening I mbibition P rogram (SIP v.1.0) and Screening Tool for Inhalation Risk (STIR v.1.0) were used to calculate upper bound estimate s of wildlife exposure via drinking water and inhalation, respectively, using momfluoro thrin’s solubility or vapor press ure, avian and mammalian toxicity endpoints.

The S creening I mbibition P rogram (SIP v.1.0, Released June 15, 2010) was used to calculate an upper bound estimate of exposure to wildlife via drinking water using momfluoro thrin’s aquatic solubility limit [ 0.933 mg/L ], the most sensitive acute avian toxicity endpoint (bobwhite quail

LD 50 >2,250 mg/kg

- bw; NOAEC < 241 mg a.i./kg

- diet), and the most sensitive acute and chronic mammalian toxicity endpoints for momfluorothrin (rat LD 50 >2,000 mg/kg

- bw, and

NOAEL = 200 mg a.i./kg

- bw, respectively). Drinking water exposure alone was determined not to be a potential pathway of concern for avian or mammalian species on an acute basis or mammalian species on chronic basis. Although not assessed due to a lack of data, drinking water is not expected to be an exposure route of concern for birds from chronic exposure to

momfluorothrin because acute drinking water exposure is not a potential pathway of toxicological concern . For a sample of the output generated by SIP v.1 .0, please see
APPENDIX C . Detailed information about the SIP v.1.0, as well as the tool, can be found on the
EPA’s website at http://www.epa.gov/pesticides/science/models _pg.htm#terrestrial

.

The S creening T ool for I nhalation R isk (STIR v.1.0, November 19, 2010) was used to calculate

an upper

- bound estimate of vapor

- phase exposure using momfluorothrin’s vapor pressure ( 1.04 x

10

- 8 mm Hg) and molecular weight ( 385.35 g/mol ) . STIR incorporates results from several toxicity studies including acute oral and inhalation rat toxicity endpoints obtained from the “six

pack” of core studies, which are a series of six guideline studies that are submitted to the Registration Division of the Office of Pesticide Programs for technical and formulated products of a pesticide [rat acute oral LD 50 >2,000 mg a.i./kg

- bw ( MRID 49020096 ) and acute inhalation

LC 50 = 1.03 mg/L (MRID 49020103), respectively], as well as the most sensitive acute oral avian toxicity endpoint (bobwhite quail LD 50 > 2,250 mg a.i./kg

- bw). Based on the results of the STIR model, inhalation exposure alone was determined not to be a potenti al pathway of concern for avian and mammalian species on an acute inhalation exposure basis ( see APPENDIX C for details).

2.6. 5

. Measures of Effect

Measures of effect are obtained from a suite of registrant

- submitted guideline studies that were condu cted with a limited number of surrogate test species ( Table 2.1 )

. No additional ecotoxicity

data on momfluorothrin were located, based on a July 2014 query of the open literature in the public ally available version of the ECOTOX database ( http://cfpub.epa.gov/ecotox/ ).

The acute measures of effect used in this baseline assessment are the LD 50 ( median Lethal Dose),

LC 50 ( median Lethal Concentration) or EC 50 ( median Effects Concentration). These are- Page 20 of 62

-

measures of acute toxicity which result in 50% of the respective effect in tested organisms. The endpoints for chronic mea sures of exposure are the no observed adverse effect concentration ( NOAEC ) and the no observed adverse effect level ( NOAEL ) . Toxicity studies were submitted

for freshwater fish and invertebrates, estuarine/marine fish and invertebrates, aquatic plants, birds, mammals

, bees , and other terrestrial invertebrates . The endpoints used for risk

characterization are derived from studies which underwent review and were classified as “acceptable” (conducted under guideline conditions and considered to be scientifically valid) or “supplemental” (conditions deviated from guidelines but the results are considered to be scientifically valid).

Table 2. 2 lists the measures of environmental exposure and ecological effects used to assess the potential risks of momfluorothrin to non

- target organisms. The methods used to assess the risk
are consistent with those outlined in the document “Overview of the Ecol ogical Risk Assessment

Process in the Office of Pesticide Programs” (USEPA, 2004).- Page 21 of 62

-

Table 2.2. Measures of Exposure and Measures of Effect Used in Assessing Potential Risks Associated with the Proposed Use s of Momfluorothrin

.

Assessment Endpoint Surrogat e Species and Measures of Ecological Effect 1 Measures of Exposure

Birds 2 Survival Lowest acute LD 50 (single oral dose test)

and LC 50 (subacute dietary test) Upper

- bound residues on

food items

Reproduction

and Growth Lowest NOAEC

(21

- week reproduction test)

Mammals Survival Lowest acute LD 50 (single oral dose test)

Reproduction

and Growth Lowest NOAEC

(2

- generation reproduction test)

Aquatic Animals ( F ish and

invertebrate s) 3 Survival Lowest tested LC 50 or EC 50 (acute toxicity test) Peak EEC s 4

Reproduction

and Growth Lowest NOAEC ( early life

- stage or full

life

- cycle test s ) 21

- day EECs for invertebrates

and 60

- day EECs for fish 4

Terrestrial plants 5 Survival and growth Lowest EC 25 (for non

- listed plants) and

corres ponding NOAEC (for listed

plants)
(endpoints derived for monocots and dicots from seedling emergence and vegetative vigor studies) Estimates of runoff and spray

drift to non

- target areas

Terrestrial invertebrates 6 Survival Lowest h oneybee LD 50 (acute contact toxicity , acute oral toxicity )

Lowest Earthworm LC 50 Maximum application rate for honeybees and estimates of

soil concentrations for

earthworms

Aquatic plants (vascular

and non

- vascular) Survival and growth Lowest EC 50 (for non

- listed plants) and

corresponding NOAEC or EC 05 (for

listed plants) Peak EEC s 4

1 The most sensitive species tested within taxonomic groups is used for screening

- level risk assessments.

2 Birds represent surrogates for terrestrial

- phase amphibians and reptiles.

3 Freshwater fish represent surrogates for aquatic

- phase amphibians

. 4 Aquatic EECs are based on modeling described in Section 3.2.2.1

. 5 Four species of two families of monocots

- one is corn, six species of at least four dicot families, of which one is soybeans.

6 Risk to terrestrial invertebrates from momfluorothrin use is not evaluated, rather the potential hazard to honey bees and earthworms (i.e. the available data) are qualitatively assessed.

2.6. 6

. Integration of Exposure and Effects

E xposure and toxicity data are integrated in order to evaluate the risks of adverse ecological

effects on non

- target species. S creening

- level risk assessment s f or broadcast

- applied pesticides

use the deterministic risk quotient (RQ) method to compare estimated exposure concentrations

with measured toxicity values. The RQ method involves dividing point estimates of

environmental concentrations by acute and chronic toxicity values. The resulting unitless RQs

are th en compared to the Agency’s L evels of C oncern (LOC ) (USEPA

, 2004) ( Table 2.3 ).

M omfluorothrin

, however, is not proposed for broadcast application, and t he nature of the proposed formulated end

- use products (aerosol spray cans) precludes confident identifi cation of an upper bound application rate . In this screening

- level risk assessment for momfluorothrin, exposures of risk concern are identified using the LOC and an effort is made to discuss the likelihood of the hypothetical exposures occurring.- Page 22 of 62

-

Table 2.3. Agency Risk Quotient (RQ) Metrics and Levels of Concern (LOC) Per Risk

Class.

RISK CLASS RISK DESCRIPTION RQ LOC

Aquatic Animals (fish and invertebrates)

Acute Potential for effects to non

- listed animals from acute

exposures Peak EEC 1 /LC 50 2 0.5

Acute

Restricted Use Potential for effects to animals from acute exposures

Risks may be mitigated through restricted use classification Peak EEC/LC 50 0.1

Acute Listed Species Listed species may be potentially affected by acute

exposures Peak EEC/LC 50 0.05

Chronic Potential for effects to non

- listed and listed animals from

chronic exposures 60

- day EEC/NOAEC (fish) 1 21

- day EEC/NOAEC (invertebrates)

Aquatic Plants

Non

- Listed Potential for effects to non

- listed plants from exposures Peak EEC 1 /LC 50 2 1

Listed Potential for effects to listed plants from exposures Peak EEC/NOAEC 1

Terrestrial Animals (mammals and birds)

Acute Potential for effects to non

- listed animals from acute

exposures EEC 3 /LC 50 (Dietary) 0.5 EEC/LD 50 (Dose)

Acute

Restricted Use Potential for effects to animals from acute exposures

Risks may be mitigated through restricted use classification EEC/LC 50 (Dietary) 0.2 EEC/LD 50 (Dose)

Acute Listed Species Listed species may be potentially affected by acute

exposures EEC/LC 50 (Dietary) 0.1 EEC/LD 50 (Dose)

Chronic Potential for effects to non

- listed and listed animals from

chronic exposures EEC/NOAEC 1

Terrestrial and Semi

- Aquatic Plants

Non

- Listed Potential for effects to non

- target, non

- listed plants from

exposures EEC 3 / EC 25 1

Listed Plant Potential for effects to non

- target, listed plants from

exposures EEC/ NOAEC 1 EEC/ EC 05

1 Aquatic EECs are based on modeling described in Section 3.2.2.1

. 2 LC 50 or EC 50

. 3 Terrestrial EECs are based on modeling described in Section 3.2.3 .1

.

3 . Analysis

3.1

. Use Characterization

Momfluorothrin is proposed for use strictly in the form of hand

- held aerosol spray can end use products for indoor and outdoor use . Proposed application methods for momfluorothrin include

s pot

, crack

- and

- crevice , and wasp and hornet nest treatments only

. There are no p roposed

m aximum application rates and no restrictions on retreatement intervals. Therefore, this assessment qualitatively evaluates potential exposure resulting from outdoor use by considering a variety of exposure scenarios

. Indoor uses of momfluorothrin products are not considered to- Page 23 of 62

-

contribute to ecological risk because the potential for outdoor exposure associated with these

uses is low.

Table 3.1. Proposed Momfluorothr in End

- use Product Labels

Label Product Weight Percent
Momfluorothrin (total grams

momfluorothrin a.i. ) Other Active

Ingredient (Percent a.i.) Notes

Sumitomo

10308

- GA 7.1 oz 0.1 (20 ) d

- phenothrin (0.20) No freshwater buffer use

restriction

MGK

- 29811 6

- 20 oz 0.0 25 ( 4

- 14) Cypermethrin (0.05) “ For indoor residential use only ”

MGK

- 29831 6

- 20 oz 0.05 ( 8.5

- 28) PBO (0.40) “Outdoor applications

limited to crack

- and

crevice or spot surface

treatments”

MGK

- 29871 6

- 20 oz 0.05 (8.5

- 28) d

- phenothrin (0.20) “Outdoor applications limited to spot or crack

and

- crevice and wasp and
hornet nest treatments... Spray [wasp and hornet nests] until can is empty”

MGK

- 29872 6

- 20 oz 0.05 (8.5

- 28) d

- phenothrin (0.20) Formulated for the utility industry ; “Spray [wasp and hornet nests] until can is empty”

3.2. Exposure Characterization

3.2.1. Environmental Fate and Transport Characterization

The general physical/chemical properties of m omfluorothrin are summarized in Table 3.2

. Environmental fate and transport properties of m omfluorothrin a re characterized in further detail in the following sections , and data specific to momfluorothrin are noted . The Agency’s understanding of these properties is limited by the available dataset. Data submitted using

m omfluorothrin is summariz ed in Appendix A

.

Table 3.2 Chemical Identifiers, Structure, General Physical and Chemical Properties of

Momfluorothrin.

Parameter Value Reference

PC code 016331

--

CAS No. 609346

- 29

- 4

--

Structure

--- Page 24 of 62

-

Parameter Value Reference

Chemical name (IUPAC) 2,3,5,6

- tetrafluoro

- 4

- (methoxymethyl)benzyl (EZ)

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

- 3

- (2

-

cyanoprop

- 1

- enyl)

- 2,2

- dimethylcyclopropanecarboxylate --

SMILES code C1(=C(C(=C(C(=C1F)COC(=O)C2C(C2C=C(C#N)C )(C)C)F)F)COC)F http://pubchem.n cbi.nlm.nih.gov/

edit2/index.html

Common name Momfluorothrin (research code: S

- 1563)

--

Chemical formula C 19 H 19 F 4 NO 3 -- Molecular weight 385.35 g/mol Leslie and Moseley (2010)

Water solubility (20oC, pH 7) 0.933 mg/L Leslie and Moseley (2010)

Vapor pressure (25oC) 1.04 x 10

- 8 Torr (mm Hg) Moseley (2011)

Henry's law constant 1.01 × 10

- 9 atm

. m 3 mole

- 1 Foster (2012)

Octanol

- water partitioning coefficient Log K OW (20oC, pH 7) 2.88 MRID #

49019924

49019925

Momfluorothrin has a high soil adsorption (K oc ≤ 4344 ), based on FAO Soil Mobility

c lassification and a tendency to partition to sediment in aquatic systems. The reported log octanol/water partition coefficient value ( 2.88 ) suggests that m omfluorothrin ha s the potential to bioaccumulate in aquatic organisms, assuming that chemical metabolism is negligible.

Momfluorothrin has a molecular weight of 385.3 g/mmol. With a vapor pressure of 1.04 x10

- 8 mm Hg and a limited solubility, the calculated Henry’s Law Cons tant for momfluorothrin is relativiely low ( 1.01 x10

- 9 atm

- m 3 /mol). Table 3.2 lists various important physicochemical

characteristics of the chemicals. A summary of the submitted environmental fate and transport

data is provided in Table 3.3

.

Laboratory studies have indicated that m omfluorothrin degrade s through a combination of biotic

and abiotic reactions and is slightly persistent in the environment. Under acidic and neutral conditions this compound is relatively stable to hydrolysis, but i t undergoes hydrolysis at pH 9,

with half

- lives of approximately 12 days at 20°C and 7 days at 25°C.

Momfluorothrin is susceptible to aqueous photo lysis with a half

- li f e of 32 days. Momfluorothrin

is shown to biodegrade in aerobic soils with half

- lives < 5 days, and under ae robic aquatic systems with half

- lives < 3 days

. Momfluorothrin is considered slighltly mobile in soils based on the FAO soil mobility classification (K oc as high as 4344 L/Kg) and its potential to leach into groundwater is low ( USEPA, 2006 ) . If released to water, m omfluorothrin will rapidly partition to the sediment compartment which acts as an environmental sink for this compound. In an acceptable aquatic metabolism study, m omfluorothrin appears to degrade rapidly w ith reported half

- life < 3 days

. Momfluorothrin has low potential to accumulate in fish (log k ow < 3)

. The steady

- state bioconcentration factors based on the measured [ 14 C] residue concentrations for the whole fish were 612 and 600 in the low and high concentration, respec tively . The depuration

half

- life for [ 14 C] residue was approximately 9.8 and 12 days in the low and high concentration- Page 25 of 62

-

levels, respectively.

Table 3.3 Environmental Fate Data Summary for Momfluorothrin plus Degradates Observed in Study

Property Value / Degradates observed Reference

Hydrolysis half

- life: pH 5

pH 7 pH 9 stable

stable

6.5

- 7.2 days at pH 9

. MFOA (96.2% AR in alc

- RTZ

, pH 9 at 50 °C ) and

Z

- CMCA (94.1 % AR in acid

- RTZ, pH 9 at 40 °C ). MRID
49019941

Aqueous photolysis half

- life

Dark

- corrected 40°N latitude 31.7 days MRID
49019943

Aerobic soil metabolism half

life Alc

- labeled RTZ 3.3 day

Acid

- labeled RTZ 2

– 4.2 day

Acid

- labeled RTE 1.4

- 4.9 day

14 CO 2 ranged from 37.0% AR to 51.4% AR at the end
of the incubation MRID
49019947

Aerobic aquatic metabolism
half

- life (total system) < 3 days

MFOA

- D (maximum of 72.9% of AR)

TFPA detected in both test systems (10.5% AR)

Z

- CMCA (83.7% of AR) Omega c

- CONH 2 - d

- t

- CRA (21% of AR)

E

- CMCA (64.3 % of AR) MRID
49019949

Adsorption coefficient

K
oc (L/Kg) 4344 (S ediment )
1087

– 1213 (Sandy loam) 1063 (loam) 1033 (Clay loam) MRID
48535669

Terrestrial Field Dissipation Study Waived for the proposed use pattern

--

Bioconcentration factor (BCF) (L/kg) Edible: 231

Nonedible: 1106

Whole fish: 600 MRID
48535624

Degradation products under various environmental conditions are shown in Figure 3. 1.- Page 26 of 62

-

Figure 3. 1. Nomeclature and Structures of Potential Degradation Products of Momfluorothrin- Page 27 of 62

- 3.2.2. Measures of Aquatic Exposure

3.2.2.1. Surface Water Exposure

No drinking water assessment was performed. EFED believes that based on the use pattern (i.e. ready

- to

- use spray cans), while some ou t door exposure is possible

, it is unlikely the use will yield aquatic exposures that will impact drinking water. For that reason, n o quantitative drinking water assessment ( D WA) has been conducted for these p r oducts and t h is use pattern. EFED
believes that this eva l uation is consistent w i th previous assessments for this particular outdoor

use pattern for other pestic ides. Should the registrant amend or add to this use pattern

, EFED will

reconsider the need for a D WA depending on the nature of t he change s ( DP Barcode: 410074; 02/12/2014).

P otential aquatic exposure to momfluorothrin is not quantified directly for the aerosol spray uses since the proposed use patterns are not comparable in scale to broadcast use patterns ( e.g. , agricul tural or public health applications) around which the current exposure models have been designed. Instead, EFED estimates the amount of active ingredient that would have to reach a water body to result in risk to non

- target organisms and qualitatively discusses the likelihood that this might happen. The proposed labels state that direct application to water is not allowed. Additionally, since this is a new chemical there is no monitoring data.

Exposure estimates were calculated a ssuming e ach can contains 500 g product and 0.1% a.i (EPA Registr a tion No_1 0308

- GA )

, and assuming simultaneous release to a pond with water volume of

20 x 10 6 L ( i.e.

, standard pond size used in PRZM

- EXAMS)

. Detailed information about the standard pond and PRZM and EXAMS models can be found on the EPA’s website at http://www.epa.gov/opp00001/science/models_pg.htm#aquatic

.

3.2. 3

. Measures of Terrestrial Exposure

3.2.3.1

. Terrestrial Wildlife

Terrestrial exposure estimates for avian and mammalian risk assessments were derived us ing the Terrestrial Residue EXposure model ( T

- REX ) (version 1.5

, 03 / 22 / 2012 ). The assumption of the

model is that mammals and birds (surrogates for terrestrial

- phase amphibians and reptiles) may be exposed via their consumption of treated food items contaminated by direct spray or spray drift as a result of application. Typically, exposure (via pesticide application rate) and t oxicity (via ecotoxicology test endpoints for birds and mammals) are integrated to determine risk quotients. However, since exposure resulting from the proposed momfluorothrin uses is not easily quantified, the equation was rearranged to compare the level s of risk concern to avian and mammalian ecotoxicology data so as to identify unacceptable acute and chronic environmental exposure threshold s

. The likelihood of exposures exceeding these thresholds following labeled use was qualitatively evaluated. Detai led information about the T

- REX model can be found on
the EPA’s website at : http://www.epa.gov/oppefed1/models/terrestrial/trex/t_rex_user_guide.htm#Section2_3- Page 28 of 62

- 3. 2

. 3.2. Terrestrial Plants

Terrestrial plant exposure is not considered quantitatively for the proposed momfluorothrin aerosol spray can formulations, but is qualitatively discussed in the Risk Description

.

3.3

. Ecological Effects Characterization

In screening

- level ecological risk assessments, effects characterization describes the types of effects a pesticide can have on aquatic and terrestrial organisms. This characterization is based on the registrant

- submitted toxicity data for birds, mammals, fish, aquatic and terrestrial invertebrates, and aquatic and terrestrial plants for momfluorothrin and a typical formulated end

use product ( e.g. , momfluorothrin co

- formulated with phenothrin , cypermethrin, or PBO ). B irds are used as surrogates for reptiles and terrestria l

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

- phase amphibians

.

In addition to the data submitted in support of registration, the public version of ECOTOX (ECOTOXicity) database was searched for additional toxicity data from the open literature. The ECOTOX database is a publicly

- available, quality

- assured, comprehensive tool for locating toxicity data from the open literature and is maintained by EPA Mid

- Continent Ecology

Division. More information on ECOTOX can be found at: http://www .epa.gov/ecotox

. Research papers are thoroughly screened using standard procedures before being accepted into ECOTOX thereby ensuring consi stent, high quality information. For momfluorothrin , no studies

were identified in ECOTOX as of July 2, 2014

.

Given that momfluorothrin is a new active ingredient with no previous registration in the U nited

States , it is assumed that no ecological incid ents exist for momfluorothrin

.

3.3. 1

. Aquatic Toxicity Assessment

The most sensitive acute and chronic effects measurement endpoints available for

momfluorothrin exposure to freshwater and estuarine/marine species are summarized in Table
3.1 3

. All acceptable and supplemental studies available for the registration of momfluorothrin

are described in Appendix B , and the tested material ( e.g

. , momfluorothrin technical, momfluorothrin plus phenothrin formulated product ) is specified

.

3.1 3 . Summary o f most sensitive endpoints from submitted aquatic toxicity studies for technical grade
momfluorothrin

.

Exposure
Scenario Species Exposure
Duration Toxicity

Reference
Value Effects Reference / Study
Classification Toxicity

Category

Freshwater Fish

Acute Rainbow

trout
( Oncorhynch 96 hours LC 50 = 1 .2 μg a.i./L Mortality MRID 49019959 Acceptable Very Highly

Toxic- Page 29 of 62

-

3.1 3 . Summary o f most sensitive endpoints from submitted aquatic toxicity studies for technical grade
momfluorothrin

.

Exposure
Scenario Species Exposure
Duration Toxicity

Reference

Value Effects Reference / Study
Classification Toxicity

Category

us mykiss )

Chronic Fathead

minnow

( Pimephales promelas ) 32 days NOAEC = 3.1 μg a.i./L

LOAEC = >3.1 μg ai/L No effects on

survival and growth MRID 49019963

Acceptable Not

Applicable

Freshwater Invertebrates

Acute Water flea

( Daphnia

magna ) 48 hours EC 50 = 7.8 μg a.i./L Mortality MRID 49019952 Acceptable Very Highly

Toxic

Chronic Water flea

( D

. magna ) 21 days NOAEC = 3.1 μg a.i./L

LOAEC = 9

. 3 μg ai/L Growth and

reproduction MRID 49019961

Acceptable Not

Applicable

Benthic Organisms

Chronic Midge

( Chironomus
dilutus ) 49 days NOAEC < 13 μ g a.i./kg sediment (1.8 μg a.i./L pore water)

LOAEC = 13 μ g a.i./kg sediment Mortality and

Growth MRID 49019968

Supplemental, for qualitative use only Not

Applicable

Estuarine/Marine Fish

Acute No data available

Chronic No data available

Estuarine/Marine Invertebrates

Acut e No data available

Chronic No data available

Aquatic Plants Duckweed ( Lemna gibba ) 7 days IC 50 > 2,500 μg a.i./L

NOAEC = 2,500 μg a.i./L No toxicity MRID

49019988 Supplemental Toxicity

categories are not specified for plants Green algae ( Pseudokirchneriella subcapitata ) 96 hours IC 50 : Could not

be determined

NOAEC: 370 μg a.i./L Potential

interference

from co

- solvent

confounds interpretation of

treatment

responses MRID

49019991 Supplemental , for qualitative use only Toxicity

categories are not specified for plants

3.3.1.1 Toxicity to Freshwater Fish- Page 30 of 62

-

The acute toxicity of technical grade momfluorothrin to freshwater fish was evaluated in several species, with 96

- hour LC 50 values ranging from 1

. 2 μg a.i./L in rainbow trout (MRID 49019959 )

to 7.6 μg a.i./L in fathead minnow (MRID 49019957 ). Based on these results, momfluorothrin is categorized as very highly toxic to freshwater fish on an acute basis.

A study assessing the acute toxicity of one momfluorothrin

- plus

- phenothrin formulation in

rainbo w trout was also submitted. The momfluorothrin

- plus

- phenothrin formulation contained

0.12% w/w momfluorothrin and 0.25% w/w phenothrin . The 96

- hour LC 50 value reported for this product is 2,700 μ g formulation/L ; 1.3 μg momfluorothrin /L or 6.6 μg phenothrin /L (MRID 49020222) , indicating that this formulated product of momfluorothrin is moderately toxic to

freshwater fish. This study also indicates that the acute toxicity of momfluorothrin to rainbow trout is not enhanced in the mixture compared to exposure to momfluorothrin alone.

An early life stage study with fathead minnow was submitted by the registrant to establish the chronic toxicity of technical grade momfluorothrin to freshwater fish (MRID 49019963 ).

Results of this 3 2

- day exposure study showed no significant effect s to embryo hatching success, the number of live normal larvae at hatch ( i.e ., larval survial), post hatch survival, total length, and dry weight at concentrations up to 3.1 μg a.i./L, yielding a 30

- day NOAEC value for survival

of 3.1 μg a.i./L.

3.3.1.2

. Toxicity to Freshwater Invertebrates

A vailable a cute toxicity studies of momfluorothrin to freshwater invertebrates include a 48

- hour daphnia test with technical grade momfluorothrin ( EC 50 of 7.8 μg a.i./L; MRID 49019952 ) and a

48

- hour daphnia test with formulated product containing a mixture of 0.12% momfluorothrin and

0.25% phenothrin active ingredients ( EC 50 of 19,000 μg formulation /L; MRID 49020220 )

. Comparison of the 48

- hour EC 50 values for momfluorothrin TGAI (7.8 μg a.i./L) and

momfluoro thrin formulation (16.5 μg a.i./L) indica tes that the formulated product tested has a similar order of toxicity to technical grade momfluorothrin

. Based on these results,

momfluorothrin can be categorized as very highly toxic on an acute basis.

Two c hronic toxicity studies with technical grade momfluorothrin were submitted for freshwater

invertebrates ; a 21

- day daphnia lifecycle toxicity study (MRID 49019961 ; acceptable ) , and a 49

- day midge lifecycle test in a water

- sediment system (MRID 49019968 ; sup plemental for qualitative use only )

. Dry weight, length, number of live offspring, time to first brood, and

successful birth rat e were all significantly affected endpoints at the highest concentration tested,

9.3 μg a.i./L , in the chronic daphnia study. T oxicity values for the sediment toxicity study are expressed in terms of time

- weighted average concentration s of momfluorothrin in se diment (μg a.i./kg)

. The sediment toxicity test with midge determined statistically significant effects to male development rate and combined male

- female development rate at concentrations as low as 13 μg a.i./kg sediment (1.8 μg a.i. /L pore water) , the lowest test concentration

. Since a d efinitive

NOA EC value is not available from the chronic midge study

, there is increased uncertainty surrounding the momfluorothrin toxicity threshold for this taxon

.

3.3.1.3. Toxicit y to Estuarine/Marine Fish and Invertebrates- Page 31 of 62

-

No acute or chronic estuarine/marine fish or estuarine/marine invertebrate toxicity studies were

submitted for momfluorothrin

.

3.3.1.4. Toxicity to Aquatic Plants

The 7

- day toxicity of technical grade momfluorothrin to aquatic vascular plants was evaluated

for Lemna gibba , with an IC 50 greater than 2,500 μg a.i./L (MRID 49019988; supplemental). The

96

- hour toxicity of technical grade momfluorothrin to aquatic non

- vascular plants was evaluated

for Pseudokirchneriella subcapitata

, although a n EC 50 could not be reliably determined because

of potential interference from the co

- solvent (MRID 49019991; supplemental for qualitative use only ).

3. 3.2 Terrestrial Effects Characterization

The most sensitive acute and chronic toxicity reference values available for momfluorothrin exposure to mammals, birds, and terrestrial invertebrates are summarized in Table 3.14

. All acceptable and supplemental studies available to support the registrati on of momfluorothrin are

described in Sections 3.3.2.1. through 3.3.2.4.

, and the tested material ( e.g. , momfluorothrin technical, momfluorothrin plus phenothrin formulated product) is specified for each study

.

Table 3.14 Summary of most sensitive endpoints from submitted terrestrial animal toxicity studies for technical grade momfluorothrin.
Species (common name) Taxa

Represented Exposure

Duration Effect Endpoint Reference/

Classification Acute

Toxicity

Classification

Laboratory

Rat ( Rattus norvegicus ) Mammals Acute (oral) Mortality LD 50 > 2,000 mg a.i./kg

- bw * MRID

49020096 Acceptable Practically

non

- toxic

Acute (inhalation) Mortality L C 50 > 1.03 mg/L * MRID

49020103 Acceptable Practically

non

- toxic

Chronic Decreased

F1 and F2

pup weight NOAEC = 200

mg a.i./kg diet

LOAEC = 500 mg a.i./kg diet MRID

49020018 Acceptable Not

Applicable

Bobwhite quail ( Colinus virginianus )

Birds,

terrestrial

phase amphibians, and reptiles Acute Mortality LD 50 >2

, 250 mg a.i./kg

- bw MRID

49019971 Acceptable Practically

non

- toxic

Zebra finch ( Poephila

guttata ) Acute Mortality LD 50 > 2

, 250 mg a.i./kg

- bw MRID

49019973 Supplemental Practically

non

- toxic

Mallard duck ( Anas platyrhynchos ) Acute Mortality LC 50 >5

, 620 mg a.i./kg diet MRID

49019977 Acceptable Practically

non

- toxic

Bobwhite quail ( Colinus virginianus ) Chronic Adult

female weight gain NOAEC < 241

mg a.i./kg diet

L OAEC = 241 mg a.i./kg diet MRID

49019979 Supplemental Not

Applicable- Page 32 of 62

-

Table 3.14 Summary of most sensitive endpoints from submitted terrestrial animal toxicity studies for technical grade momfluorothrin.
Species (common name) Taxa

Represented Exposure

Duration Effect Endpoint Reference/

Classification Acute

Toxicity

Classification

Honey bee ( Apis mellifera

L. ) Terrestrial

invertebrates Acute Moratlity Contact LD 50 = 0.2 μg a.i./bee MRID

49019985 Acceptable Highly toxic

Acute Mortality Oral

LD 50 = 5.08 μg

a.i./bee Not Applicable

*Testing was conducted with a 15% a.i. momfluorothrin formulated product , not TGAI

.

3.3.2.1. Toxicity to Mammals

Mammalian toxicity data submitted to the Office of Pesticide Programs ’ Health Effects Division (HED) are used to approximate toxicity to wild mammals. These studies are typically conducted with laboratory rats ( Rattus norvegicus ) or mice ( Mus musculus ). No studies evaluating toxicity to wild mammal species have been submitted to the Agency for momfluorothrin

.

The reported laboratory rat acute oral LD 50 value is >2,000 mg/kg

- bw for a momfluorothrin

formula tion (15.5% a

. i

. ) (MRID 49020096). Based on the reported laboratory rat oral LD 50 value, momfluorothrin is practically non

- toxic to small mammals

. Acute dermal (MRID 49020098) testing with rats also determined an LD 50 >2,000 mg/kg

- bw for momfluorothrin. An acute inhalation toxicity study with a momfluorothrin formulation (15.5% a.i.) (MRID 49020103) , while producing no mortalities, found clinical signs included tremor, tremor of tail, ataxic gait or urinary incontinence observed in females exposed to 1 .03 mg/L

.

In the available two

- generation rat reproduction study with technical momfluorothrin , the

NOAEL is 200 mg/kg diet based on decreased F1 and F2 pup body weight s (MRID 49020018).

In the submitted chronic rat dietary study with technical momfluorothrin (MRID 49020020)

, the systemic toxicity LOAEL is 1,500 mg/kg diet (82.6/103.1 mg/kg/day) based on decreases in bodyweight a nd bodyweight gain in females, among other tissue

- level effects , and the systemic toxicity NOAEL is 500 ppm (76/82 mg/k g/day).

3.3.2.2. Toxicity to Birds

The results of acute oral toxicity testing for momfluorothrin indicates that it is practically non

toxic to avian species on an acute oral basis. The acute oral LD 50 value for bobwhite quail ( Colinus virginianus ) is > 2250 mg a.i./kg

- bw and no clinical signs of toxicity were observed at any treatment level (MRID 49019971). Acute oral toxicity of momfluorothrin to a passerine species was evaluated with zebra finch ( Poephila guttata ). The study (MRID 49019973 ) is

classi fied as supplemental because of replacement of two birds in two treatments that regurgitated following dosing , but is considered suitable for quantitative use in risk assessment. Results of this study indicate that momfluorothrin is practically non

- toxic to passerine birds (LD 50 >2250 mg a.i./kg

- bw).

The results of the sub

- acute dietary toxicity studies available for momfluorothrin indicate that it- Page 33 of 62

-

can be categorized as practically non

- toxic to avian species on an acute dietary basis. The LC 50 for momfluo rothrin is greater than 5,620 mg a.i./kg

- diet for mallard duck ( Anas platyrhynchos ) (MRID 49019977) and bobwhite quail (MRID 49019975).

Two avian reproduction studies were received and reviewed for momfluorothrin

. In a reproduction study with mallard (M RID 49019981), a 37% reduction in the number of eggs laid in the highest treatment compared to the negative control resulted in a NOAEC of 483 mg a.s./kg

diet

. In a supplemental reproduction study with bobwhite (MRID 49019979), a dult female weight gain wa s significantly reduced compared to the control at the lowest test concentration

such that a no

- effect concentration could not be determined.

3.3.2.3. Toxicity to Terrestrial Invertebrates

The Agency guidelines for terrestrial invertebrate tests are for honey bees ( Apis mellifera ). The

acute contact LD 50 value for technical grade momfluorothrin is 0. 20 μg a.i./bee and the oral LD 50 value for technical grade momfluorothrin is 5.08 μg a.i./bee ( MRID 49019985 ). Based on the

acute contact LD 50 , momfluo rothrin is classified as ‘highly toxic’ to honey bees.

In addition, the Agency received a honey bee foliar residue toxicity study conducted under the Agency guideline (MRID 49020224 ). The test substance was a momfluorothrin formulated end

use product containing 0.1% momfluorothrin and 0.2% d

- phenothrin; the crop treated was

alfalfa. The RT 25 was determined to be less than three hours, al hough it is uncertain whether the 15 g a.i./ha ap plication rate is representative of exposure that would be expected to result from

momfluorothrin aerosol use as labeled.

A sub

- acute earthworm toxicity test (MRID 49019983) was also submitted and reviewed. T he

LC 50 following a 14

- day exposure was dete rmined 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.

3.3.2.4. Toxicity to Terrestrial Plants

The seedling emergence and vegetative vigor toxicity of momfluorothrin formulated product (0.1% a.i. momfluorothrin and 0.2% a.i. d

- phenothrin) to terrestrial p lants was evaluated for

monocot ( wheat

, Triticum aestivum ) and dicots ( cucumber

, Cucumis sativus ; cabbage

, Brassica
oleracea ; and tomato

, Lycopersicon esculentum ) in a dual

- concentration limit test

. Observations of phytotoxic response (percentage of necrotic area, effects on plant length, dry weight and germination) following exposure to formulated product of momfluorothrin (0.1% a.i.) applied at

the 50 0 g/10 m 2 rate were limited to monocot necrosis ; whereas exposure to the same formulated product applied at the 5000 g/10 m 2 rate resulted in observed phytotoxic response encompassing reduced germination, necrotic area, and height. The study (MRID 4902022 7 ) is classified supplemental because of the limited number of crop species tested and because it is uncertain

whether the selected application rates are representative of exposure that would be expected to

result from labeled momfluorothrin aerosol use

.- Page 34 of 62

-

4. Risk Characterization

4.1. Risk Estimation

Being a qualitative assessment

, th is analysis does not include standard risk estimation since the proposed formulated end

- use products (aerosol spray cans) preclude confident identification of an upper bound application rate. Instead, e xposures of risk concern are identified using the LOC and an effort is made to discuss the likelihood of the hypothetical exposures occurring. These comparisons of toxicity to exposure are included as part of t he risk descrip tion

.

4.2. Risk Description

The p roposed uses of momfluorothrin are unlikely to adversely affect fish (surrogate species for aquatic

- phase amphibians) a nd aquatic invertebrates on both an acute and chronic exposure

basis , and adverse effects to aquatic plants are not expected

. A quatic risk predictions for fish and aquatic invertebrates are low under EFED’s standard exposure scenario due to the nature of the proposed uses and aerosol form ulations. While much smaller water bodies in close prox imity to treated areas may have increase d vulnerability due to the highly toxic nature of the product , the requisite exposure to reach risk levels of concern is unlikely considering that direct application to water is prohibited and runoff is mitigated by the labels’ restriction regarding applications near surface water ( i.e. , the 25 foot buffer)

. Neither is spray drift expected to contribute to aquatic

exposure, considering the jet spray release feature of the aerosol products proposed for registration

. Adverse acute and chronic effects to birds (surrogate species for terrestrial

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

- target insects are likely to result from exposure, exposure s of adverse effect threshold magnitude are likely to be spatially and temporally limited ; thus risk to non

- target terrestrial invertebrates is unlikely

. Further , the number of indiv iduals that could be adversely affected during or after spot

or crack

- and

- crevice spray treatment are considered to be few in number such that direct adverse effects to colony survival are not expected. The magnitude of terrestrial and aquatic exposure s that can reasonably be expected to result from use of the momfluorothrin aerosol spray products

is the greatest uncertainty in this risk assessment.

4. 2 .1. Risk to Aquatic Organisms

S ince the proposed use patterns (aerosol spray uses ) are not comparab le in scale to broadcast use
patterns ( e.g.
, agricul tural or public health applications) around which the current EFED exposure models have been designed

, model estimated e xposure concentrations (EECs) for

momfluorothrin were not calculated

. Instead, EFED estimate d the amount of active ingredient

contained in the runoff from a 10 h ectare field that would have to reach a water body to result in

risk to non

- target organisms (referred to as EECs) and qualitatively discusses the likelihood that

this exposure s cenario might occur

. The aquatic exposure assessment is conservative in that compound fate properties ( e.g. degradation, sorption) are not considered during transport to and

occurrence with in the pond

.- Page 35 of 62

-

Assuming e ach can contains 500 g product and 0.1% a.i , if emptied in a pond with water volume

of 20 x 10 6 L:

Concentration from one can = 500 mg a

. i

. 20

, 000

, 000 L = 0

. 000025 mg a

. i

. / L

 2.5 cans will result in EECs exceeding the acute listed species LOC for fi sh.

 24 cans will result in EECs exceeding the acute non listed species LOC for fish.

 16 cans will result in EECs exceeding the acute listed species LOC for freshwater

invertebrates.

 It would take more than 150 cans to reach EECs exceeding the acute non listed species LOC

for freshwater invertebrates.

 It would take more than 100 cans before EECs exceed the chronic LOC for freshwater fish

and (pelagic) invertebrates.

 It would take more than 300 cans before EECs would exceed the listed species LOC for aquatic vascular and nonvascular plants.

For example , to calculate the acute listed fish EEC :

LOC ∗ LC 50 = EEC

0

. 05 ∗ 0

. 0012 mg a

. i

. / L = 0

. 00006 mg a.i./L

This risk assessment of momfluorothrin shows that aquatic systems are potentially at risk f rom acute and chronic toxic exposure to this chemical. Evaluation of this risk to aquatic organisms was approached by dividing the aquatic system into two general compartments, the water column

and the benthos.

The first compartment, the water column, w hich is defined as the aquatic area between surface and the benthos (approximately 6 inches above the bottom) represents an area where organisms

are free

- swimming and can feed and breed at the surface, mid water and/or on the benthos (sediment). Direct pes ticidal contact (e.g., gill lamella, ingestion, and integument) to these organisms is assumed to be from the surface water via drift and/or runoff. The toxicity assessment points are the acute LC 50 / EC 50 and chronic NOAEC that are generated through

standa rd water column toxicity tests.

The second aquatic compartment to be considered is the benthos, which is composed of sediments and an area 6 inches above the sediment (epibenthos). The benthos is composed of a diversity of aquatic invertebrates (e.g., in sect larvae, crustaceans, mollusks) and species of fish (e.g., catfish, loachs), as well as certain critical life stages of organisms that reside in the water column; the benthos is also the initial breeding strata and nursery area for several species of f ish, especially commercial species such as salmonids. The benthos can also be a source of food items for several species of fish that are actively feeding on the organisms in the sediment and/or capturing organisms that are emerging from this area.- Page 36 of 62

-

Aquat ic Animals: Water Column Exposure

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

- phase amphibians) and aquatic invertebrates on an acute exposure basis. Considering the hypothetical discharge of momfluorothrin formu lated product directly into the standard EFED 20 million liter

farm pond, acute listed species LOCs would be exceeded following release of more than two and 10 cans for freshwater fish and freshwater invertebrates, respectively. While this particular

expo sure scenario ( which would qualify as product misuse because of water buffer distance

restrictions on the proposed labels 1 ) is unlikely to be realized in the environment, it serves to illustrate how toxic this active ingredient is to freshwater fish and invertebrates even when diluted in a very large volume of water. With a lesser volume receiving water body ( e.g. , vernal

po ols, small ponds ) a corresponding ly lesser product volume would result in the same LOC exceedances, such that release of the contents of a single can could adversely affect aquatic organisms if exposure pathways were complete. However, exposure pathways a re not considered complete because runoff should be mitigated by the labels’ 25 foot buffer from

surface water and the limited spray drift associated with the jet spray products.

On a chronic basis, f

reshwater invertebrate growth and reproduction were found to be adversely

affected , but the exposure concentrations that would result in RQs exceeding the chronic LOCs

for freshwater fish and invertebrates are very high; it would take more than 100 cans in the EFED farm pond to reach that threshold

. Anothe r consideration is that the fathead minnow tested in the submitted chronic fish toxicity study was not the most acutely sensitive species tested. Employing an acute

- to

- chronic ratio (ACR) using available acute and chronic fathead minnow toxicity endpoints and acute toxicity endpoints for the rainbow trout, the chronic fish NOAEC changes from 3.1 μg/L to 0.5 μg/L, a reduction of more than 80%. Using the chronic toxicity endpoint determined via the ACR approach, the contents of 20 cans in EFED’s standard

fa rm pond would exceed the fish chronic LOC, though, with a lesser volume receiving water body ( e.g. , vernal pools, small pond s ) a corresponding ly lesser product volume would result in chronic LOC exceedances, such that release of the contents of a single ca n could adversely affect aquatic organisms if exposure pathways were complete

. However, exposure pathways are not considered complete because runoff should be mitigated by the labels’ 25 foot buffer from surface water and the limited spray drift associate d with the jet spray products.

No acute or chronic toxicity data for estuarine/marine animals were submitted , but considering

the 25 foot buffer and the anticipated degradation, metabolism, and dilution following release of the product

— prior to it reaching estuarine/marine habitat areas

— risk is considered unlikely

. Consideration must also be given to the fact that additional toxicity data would not be particularly helpful for refining the risk picture for a qualitative assessment such as this one.

Aquatic Animals: Sediment Exposure

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 un certainty, the magnitude of exposure that might reasonably be expected to result from use

1 The proposed label for EPA Registration No. 10308

- GA does not currently restrict application distance from

freshwater- Page 37 of 62

-

is undefined . Pyrethroids as a class tend to partition to sediments, and tend to be very highly

toxic to benthic invertebrates ; however, the Koc values for momfluoro thrin are much lower than Koc values for other pyrethroids

. P opulations of benthic aquatic invertebrates are unlikely to be adversely affected by labeled use of momfluorothrin aerosol spray products because of limited exposure potential. The likelihood of runoff is lessened by the labels’ 25 foot buffer from surface water and spray drift resulting from use of the proposed momfluorothrin jet spray products is expected to be minimal. C omplete exposure pathways for momfluorothrin and aquatic animals

are unli kely considering that runoff or spray drift would occur at least 25 feet away from aquatic receptors, a buffer zone where some combination of sorption, degradation, and/or metabolism would be expected to substantially reduce bioavailable concentrations

. A n y momfluorothrin entering the water body would be spatially limited and further, subject to dilution.

Aquatic Plants

Since it would take more than 300 cans being dumped directly into the modeled pond before EECs would exceed the listed species LOC for aquatic vascular and nonvascular plants, potential risk to aquatic plants from the proposed uses of momfluorothrin is considered to be low.

4. 2 .2. Ris k to Terrestrial Organisms

There is no maximum application rate currently included on the proposed momfluorothrin end

use product labels ; therefore, t errrestrial exposure s that would result in RQs exceeding the LOC

were back

- calculated from the LOC using available toxicity data (and only where definitive toxicity data were available).

4. 2 .2.1. Risk to Mammals

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 momfluorothin

- treated food items from spray dr ift or large quantities of dispersed product is unlikely . Acute risk to mammals is considered to be low.

The chronic mammalian dietary study determined a no

- effect value of 200 mg a.i./kg

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

, exposure would have to be greater than 200 ppm. Using

T

- REX, it was determined that the application rate would have to be greater than 0.8 lbs a.i./acre

to exceed the chronic level of concern on a dietary

- or dose

- basis ( Appendix C )

. An entire 7 ounce (2 01 g) aerosol spray can containing 0.1% a.i. momfluorothrin 2 , if uniformly distributed over a 200 square foot area 3 , 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 RQs

to exceed the chronic LOC. Therefore, chronic risk to mammals is likewise considered to be low.

2 The active ingredient percentage of the referenced product (EPA Reg. No. 10308

- GA) is the highest of all proposed momfluorothrin products. It is uncertain whether this label is the most conservative since the other proposed product labels have a weight r ange of 6 to 20 ounces.

3 The 200 ft 2 area is intended to illustrate EECs on a patio

- sized area; 200 ft 2 was not selected to represent avian or mammalian foraging area.- Page 38 of 62

- 4. 2 .2.2. Risk to Birds

O nly non

- definitive acute and sub

- acute t o xicity endpoints are available. Momfluorothrin is categorized as practi cally non

- toxic to mallard duck, bobwhite quail , and zebra finch on an acute
and subacute oral and dietary basis. Dietary e xposure to food items containing momfluorothin

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

- phase amphibians and reptiles) is expected to be

low.

Chronic avian reproduction testing with northern bobwhite found effec ts at all concentrations

tested. Since a definitive no

- eff ect concentration was not determined, it is not possible to define a threshold at which the exposure would not result in risk exceeding the level of concern

. However, since the upper bound T

- REX estimates for short grass would be approximately 21 ppm for the scenario involving uniform distribution of an entire can’s contents over a 200 square

foot area ( Appendix C ) , and 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 considering that pyrethroids as a class are not known to have chronic avian toxicity concerns

. Chronic risk to avian species is expected to be low.

4. 2 .2.3

. Risk to Terrestrial Invertebrates

M omfluorothrin exposure can be expe cted to result in acute toxicity to honey bees and is considered to be highly toxic on an acute contact (LD 50 = 0.2 ug a.i./bee) basis. Based on the application rate of 0.09 lb ai/A that was estimated from the application of the product to the 200

square foot area, acute contact risk to bees can be estimated using methodology described in

EPA’s g u idance for assessing pesticide risks to b ees (USEPA, 2014), where:

Dose/bee (ug a

. i

. /bee) = application rate (lb a

. i

. /A) * unit contact rate (ug a

. i

. /bee per lb a

. i

. /A)

Dose/bee = 0.09 lb a

. i

. /A * 2.7 ug a

. i

. /bee per lb a

. i

. /A = 0.243 ug a

. i

. /bee

A cute contact RQ = dose/bee / acute contact LD 50

A cute contact RQ = 0.243 ug a

. i

. /bee / 0.2 ug a

. i

. /bee = 1.2

Assuming that the 0.09 lb a

. i

. /A application rate is either a reasonable approximation or underestimate of exposure, t he honey bee acute contact RQ of 1.2 would e xceed the acute
contact LOC of 0.4. But the 0.09 lb a.i./A application rate likely overestimates exposure considering that the proposed momfluorothrin products are intented to control target insects where they are observed, rather than prophylactic treatment of area s having a sizable footprint, such as the hypothetical 200 square foot patio

. While e xposures potentially higher than 0.09 lb

a.i./A could occur on a much smaller target area following use of the proposed momfluorothrin products ( e.g. , the wasp and hornet nest killer products where labels instruct the user to “continue to spray into nest...until can is empty ”), the ex posure s are generally expected to be limited to footprint less than five or 10 square feet in area. Additionally

, v ery limited spray drift would be- Page 39 of 6 2

-

expected to result from the wasp and hornet killer products due to the nature of the product formulations ( i.e ., jet spray foam). As the size of the area of exposure concern decreases, the

likelihood of risk to non

- target terrestrial invertebrates also decreases. Considering the small exposure areas of concern within the developed land areas and that listed t errestrial invertebrate species’ habitat requirements greatly reduce the likelihood of co

- occurrence in the developed parcels where momfluorothrin products are projected to be used, risk to listed terrestrial invertebrates is unlikely.

Acute oral toxici ty testing with the honey bee determined an LD 50 of 5.08 ug a.i./bee. So, assuming the same 0.09 lb a.i./A application rate:

Exposure = 0

. 09 lb a

. i

.

A × 110 μ g

g × A

1 lb × 0

. 29 g day

= 2.87 μg/bee

Acute oral RQ = 2

. 87

5

. 08

= 0.57

Assuming that the 0.09 lb a.i./A application rate is either a reasonable approximation or underestimate of exposure, the honey bee acute oral RQ of 0.57 would e xceed the acute oral

LOC of 0.4. But the 0.09 lb a.i./A application rate likely overestimates e xposure, particularly on an oral basis, as the probability that listed terrestrial invertebrates would forage in the small treated area(s) is low, especially considering that the treated area ( s ) would unlikely co

- occur with suitable supporting range habita t for listed species

.

In addition to the honey bee acute oral and contact test data, the Agency received a honey bee foliar residue toxicity study which indicates that residual toxicity is not of concern for momfluorothrin applications less than or equal to 0.013 lb a.i./A ( ca. 8% of a single end

- use product can over an acre area)

. While available toxicity data indicate that adverse effects to

individual non

- target insect pollinators are likely to result from exposure

, exposure is likely to be spatially and temporally limited. Thus, the number of individuals that may be adversely affected during or after spot or crack

- and

- crevice spray treatment are considere d to be few in number such that direct adverse effects to colony survival are not expected. Conv ersely, u se of the proposed momfluorothrin end

- use products to target feral or wild bee hives, such as hives under the eaves of a residence, is an ecological risk concern.

Toxicity information for honey bees is used to develop precautionary label languag e where necessary. Based on the available data, precautionary label language for bees is necessary for

end

- use products with momfluorothrin. No two proposed momfluorothrin product labels share the same wording in the environmental hazards section; howeve r, each label should contain the following standard language:- Page 40 of 62

-

“ This product is highly toxic to bees exposed to direct treatment on blooming crops or weeds. Do not apply this product or allow it to drift to blooming crops or weeds while bees are actively visiting the area .”

Results of a subchronic study with earthworms yielded a 14

- day NOAEC of 15.6 mg a.i./kg soil for momfluorothrin applied to soil based on bodyweight loss. Based on the toxicity data available at this time, acute and chronic risk to non

- target terrestrial invertebrates is considered unlikely on account of the proposed momfluorothrin uses which have limit ed exposure potential.

4. 2 .2.4

. Risk to Non

- target Terrestrial Plants

The seedling emergence and vegetative vigor toxicity of momfluorothrin formulated product to terrestrial plants was evaluated for monocot (wheat, Triticum aestivum ) and dicots (cucumber,

Cucumis sativus ; cabbage, Brassica oleracea ; and tomato, Lycopersicon esculentum ) in a dual

concentration limit test

. Observ ations of phytotoxic response (percentage of necrotic area, effects on plant length, dry weight and germination) following exposure to a formulated product

of momfluorothrin (0.1% a.i.) applied at the 500 g/10 m 2 rate ( ca. 1 to 2.5 cans, depending on can size) were limited to monocot necrosis ; whereas exposure to the same formulated product applied at the 5000 g/10 m 2 rate ( ca. 10 to 25 cans, depending on can size) resulted in observed phytotoxic response encompassing reduc ed germination and height

, and increased necrotic area. The study (MRID 49020227) is classified supplemental because of the limited number of crop species tested and because it is uncertain whether the selected application rates are representative of expo sure that would be expected to result from labeled momfluorothrin aerosol use. The study is unsuitable for use in comparing potential exposure concentrations to toxicity values primarily because of the uncertain relevance of the selected application rates, but also because of the limited number of species tested and limited replication for the species tested.

Risk to terrestrial plants resulting from the proposed aerosol spray uses remain uncertain; however, 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

. Additional data regarding the tox icity of momfluorothrin to terrestrial plants would not likely impact the risk conclusions of this risk assessment; however, additional terrestrial plant toxicity testing would be needed to assess the risk to plants from any future broadcast use of

momfluo rothrin

.

4.3. Uncertainties and Data Gaps

4.3.2. Effects Uncertainties

The submitted chonic sediment toxicity study did not determine a NOAEC because of statistically significant increases in male development rate at the lowest concentration tested. Without a definitive NOAEC for sediment dwelling invertebrates, it is unknown how low a concentration in water or sediment pore water may elicit ad verse effects. A repeated study is not- Page 41 of 62

-

necessary for the purposes the of this risk assessment because of the proposed use pattern and predicted exposure which are presumed to be below the yet

- to

- be

- defined toxicologically

relevant threshold

.

The submit ted northern bobwhite avian reproduction study did not determine a NOAEC because of statistically significant growth effects at the lowest concentration tested. While the mallard avian reproduction study determined a definitive NOAEC, t he upland game bird reproduction study remains a data gap under the CFR requirements; however, a repeated upland game bird reproduction study is not necessary for the purposes the of this risk assessment because of the proposed use pattern and predicted exposure

.

Avian ac ute oral toxicity testing with a passerine did not determine a NOAEC because of regurgitation recorded at the lowest dose tested. Even if the birds that regurgitated the dose were counted as mortalities, the LD 50 would still be greater than the highest do se tested (2,250 mg/kg

bw). This study is considered suitable for quantitative use in this risk assessment

.

Terrestrial plant toxicity testing only looked at the response of four crop species in a two

concentration limit test design. These limit tests a re typically designed to encompass the response of 10 species. Additional uncertainty lies with the selected application rates of this study. While the upper limit dose ( ca. 10 or more cans released over a 10 m 2 area) is likely a

conservative estimate of exposure that may result from proposed use

, this dose did elicit adverse response in tested plant species.

A single aquatic nonvascular plant toxicity study is available to assess risk to this taxon. Typically four aquatic nonvascular plant studies are conducted to identify interspecies response variability

. It is uncertain whether the tested species is the most susceptible to momfluorothrin

mediated toxicological response of the standard suite of aquatic nonvascular plant surrogates ; additional aquatic nonvascular plant toxicity data will be needed to assess the risk associated with any expansion of use

.

No acute or chronic toxicity data for estuarine/marine animals were submitted. The waivers for these studies were approved because of the proposed us e pattern and associated EECs ; however, any future submissions for new uses of momfluorothrin will prompt a re

- evaluation of the data

needed for risk assessment

.

Although data on the acute toxicity of momfluorothrin is available for the daphnid, the amphi pod Hyalella azteca is known to be more acutely sensitive to pyrethroids, such as momfluorothrin

. Thus, the toxicity described in this assessment may underestimate hazard to aquatic

invertebrates.

5. Federally Threatened and Endangered (Listed) Species C o ncern s

5.1. Action Area

For listed species assessment purposes, the action area is considered to be the area affected- Page 42 of 62

-

directly or indirectly by the federal action and not merely the immediate area involved in the

action. At the initial screening

- level, the risk assessment considers broadly described taxonomic groups and conservatively assumes that listed species within those broad groups are located on or adjacent to the treated site and aquatic organisms are assumed to be lo cated in a surface water body adjacent to the treated site. The assessment also assumes that the listed species are located within an assumed area that has the relatively highest potential exposure to the pesticide, and that exposures are likely to decrea se with distance from the treatment area.

If the assumptions associated with the screening

- level action area result in risk quotients that are below the listed species LOCs, a "no effect" determination conclusion is made with respect to listed species in that taxa, and no further refinement of the action area is necessary. Furthermore, risk quotients below the listed species LOCs for a given taxonomic group indicate no concern for indirect effects upon listed species that depend upon the taxonomic grou p covered by the risk quotient as a resource. However, in situations where the screening assumptions lead to risk quotients in excess of the listed species LOCs for a given taxonomic group, a potential for a "may affect" conclusion exists and may be assoc iated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that depend upon that taxonomic group as a resource. In such cases, additional information on the biology of listed species , the locations of these species, and the locations of use sites could be considered to determine the extent to which screening assumptions regarding an action area apply to a particular listed organism. These subsequent refinement steps could consider ho w this information would affect the action area for a particular listed organism and may potentially include areas of exposure that are downwind and downstream of the pesticide use site.

5. 2

. Taxonomic Groups Potentially at Risk

The Level I screening assessment process for listed species uses the generic taxonomic group

based process to make inferences on direct effect concerns for listed species. The first iteration of reporting the results of the Le vel I screening is a listing of pesticide use sites and taxonomic groups for which RQ calculations reveal values that meet or exceed the listed species LOCs or other evidence suggests that adverse effects are likely or cannot be precluded (for more

informa tion see, USEPA, 2004).

The Agency acknowledges that pesticides have the potential to exert indirect effects upon listed organisms by, for example, perturbing forage or prey availability, altering the extent of nesting habitat, and creating gaps in the food web . In conducting a screen for indirect effects, direct effect LOCs for each taxonomic group are used to make inferences concerning the potential for indirect effects upon listed species that rely upon non

- listed organisms in these taxonomic groups as resources critical to their life cycle.

For the proposed aerosol spray can uses of momfluorothrin

, predicted environmental exposures

result in RQs less than the listed species LOCs and a “no effect” determination is made ( Table

5.1 )

.- Page 43 of 62

-

Table 5.1. Poten tial Effects to Federally Listed Taxa Associated with Direct or Indirect Effects from the Proposed Uses of Momfluorothrin

.

Listed Taxon Direct Effects Indirect Effects

Terrestrial and semi

- aquatic plants

- monocots No No

Terrestrial and semi

- aquatic plants

- dicots No No

Birds No No

Terrestrial

- phase amphibians and reptiles No No

Mammals No No

Terrestrial invertebrates No No Aquatic nonvascular plants No No Aquatic vascular plants No No

Freshwater fish No No Aquatic

- phase amphibians No No

Freshwater crustaceans No No

Mollusks No No

Marine/estuarine fish No No

Marine/estuarine invertebrates No No

5. 2 .1. Probit Dose

- Response Analysis

The Agency uses the probit dose

- response relationship as a tool for providing additional

information on the potential for acute direct effects to aquatic and terrestrial animals (USEPA, 2004) ; however, individual effect chance probabilities are of limited value to a qualitative risk

assessment and have been excluded

.- Page 44 of 62

-

6. References

Habig, C. 2012. S

- 1563: An Ecological Risk Assessment. Compliance Services International on behalf of Sumitomo Chemical Company, LTD. 40p.

Matsumura, F. 1985. Toxicology of Insecticides. 2nd ed . New York. Plenum Press. 147 p.

USEPA 1998. Guidelines for Ecological Risk A ssessment. EPA/630/R

- 95/002F. Published in 63 FR 26846; May 14, 1998. U.S. Environmental Protection Agency, Washington, DC. April, 1998.

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Enviro nmental Protection Agency. Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D.C. January 23, 2004. Online at: http://www.epa.gov/oppfead1/endanger/consultation/ecorisk

- overview.pdf

USEPA 2006. Standardized Soil Mobility Classification Guidance. U.S. Environmental Protection Agency, Office of Prevention, Pestici des and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division, Memorandum. Apr. 21,

2006.

USEPA. 2011. Water Models. U.S. Environmental Protection Agency, Pesticides: Science and Policy, Models and Databases. Last updated Aug. 8, 2011. Online at: http://www.epa.gov/oppefed1/models/w ater/

USEPA 2014 . Guidance for Assessing Pesticide Risks to Bees . U.S. Environmental Protection Agency, Office of Pesticide Programs, Environmental Fate and Effects Divisi on, June 19,

2014.

USFWS/NMFS. 2004. 50 CFR Part 402. Joint Counterpart Endan gered Species Act Section 7 Consultation Regulations; Final Rule. FR 47732

- 47762.

Urban, D.J. and N.J. Cook, 1986. Hazard Evaluation Division Standard Evaluation Procedure Ecological Risk Assessment. EPA 540/9

- 85

- 001. U.S. Environmental Protection Age ncy, Office of Pesticide Programs, Washington D.C.- Page 45 of 62

-

6.1. Submitted Environmental Fate and Transport Studies

Submitted Environmental Fate and Transport Studies

MRID

49019926 Leslie, S.; Moseley, R. (2010) S

- 1563: Development and Validation of an Analytical

Method, and Evaluation of the Water Solubility: Final Report. Project Number: RWP/0006, 1004649, 8226997. Unpublished study prepared by Covance Laboratories, Ltd. 58p.

49019927 Leslie, S.; Moseley, R. (2010) S

- 1563RTZ: Development and Validatio n of an

Analytical Method, and Evaluation of the Water Solubility: Final Report. Project Number: RWP/0007, 1004649, 8228972. Unpublished study prepared by Covance Laboratories, Ltd. 63p.

49019928 Leslie, S.; Moseley, R. (2010) S

- 1563RTE: Development and V alidation of an

Analytical Method, and Evaluation of the Water Solubility: Final Report. Project Number: RWP/0008, 1004649, 8228971. Unpublished study prepared by Covance Laboratories, Ltd. 63p.

49019924 Wright, D.; Moseley, R. (2011) S

- 1563RTZ: Determin ation of Octanol: Water

Partition Coefficient: Final Report. Project Number: RWP/0024, 1004649, 8226996. Unpublished study prepared by Covance Laboratories, Ltd. 69p.

49019925 Wright, D.; Moseley, R. (2011) S

- 1563RTE: Determination of Ocatanol: Water

Partition Coefficient: Final Report. Project Number: RWP/0025, 1004649, 8239094. Unpublished study prepared by Covance Laboratories, Ltd. 70p.



### 835.2120 Hydrolysis

MRID Citation Reference

49019941 Ponte, M. (2011) Hydrolysis of [(Carbon 14)]S

- 1563 in Buffered Aqueous

Solutions. Project Number: RWM/0012, 2055W, 2055W/001. Unpublished study prepared by PTRL West, Inc. 309p.



### 835.2240 Aqueous photolysis

MRID Citation Reference- Page 46 of 62

-

49019943 Ponte, M.; Ponte, V. (2012) Photodegradation of [(Carbon 14)]S

- 1563 in

Aqueous Solution Buffered at pH 4 by Artificial Light. Project Number: RWM/0014, 2056W. Unpublished study prepared by PTRL West, Inc. 241p.



### 835.4100 Aerobic soil metabolism

MRID Citation Reference

49019947 Ponte, M. (2012) Aerobic Soil Metabolism of [(Carbon 14)]S

- 1563 in Four

Soils. Project Number: RWM/0015, 2052W, 2052W/1. Unpublished study prepared by PTRL West, Inc. 555p.



### 835.4300 Aerobic aquatic metabolism

MRID Citation Reference

49019949 Ponte, M.; Mannella, L. (2011) [(Carbon 14)]S

- 1563: Degradation in Water

Sediment System under Aerobic Conditions. Project Number: RWM/0011, 2054W, 2054W/1. Unpublished study prepared by PTRL West, Inc. 385p.



### 850.1730 Fish BCF

MRID Citation Reference

49019966 Kang, S. (2012) Flow

- Through Biocencentration and Metabolism Study of

[(Carbon 14)]S

- 1563 with Bluegill sunfish (Lepomis macrochirus). Project Number: RWW/0025, 13048/6668. Unpublished study prepared by Smithers Viscient Laboratories. 238p.



### 835.1230 Sediment and soil ab sorption/desorption for parent and degradates

MRID Citation Reference

49019936 Ponte, M. (2012) Soil Adsorption/Desorption of [(Carbon 14)]S

- 1563 by the- Page 47 of 62

- Batch Equilibrium Method. Project Number: RWM/0016, 2059W, 2059W/1. Unpublished study prepared by PTRL West, Inc. 315p.



### 835.1240 Soil column leaching

MRID Citation Reference

49019939 Ponte, M. (2011) Estimation of the Adsorption Coefficient (Koc) of S

1563RTZ and S

- 1563RTE Using High Performance Liquid Chromatography. Project Number: RWM/0010, 2101W. Unpublished study prepared by PTRL West, Inc. 39p.



### 835.6100 Terrestrial field dissipation

MRID Citation Reference

49019951 Habig, C. (2012) S

- 1563: Waiver Request from Further

Testing: Terrestrial Field Dissipation. Project Number: RWM/0018, 650/02/112012/05. Unpublished study prepared by Compliance Services International. 16p.

Non Guideline Studies

49019945 Nishimura, H.; Suzuki, Y.; Fujisawa, T.; et al. (2011) Stability of S

- 1563 in Air

(Calculation by Atkinson's Method). Project Number: RWP/0033, STA2011A, EF/2011/040. Unpublished study prepared by Sumitomo Chemical Company. 8p.



### 6.2. Submitted Ecotoxicity Studies 850.1010 Aquatic invertebrate acute toxicity, test, freshwater daphnids

MRID Citation Reference

49019952 Fournier, A. (2011) S

- 1563

- Acute Toxicity to Water Fleas (Daphnia magna) Under

Flow

- Through Conditions. Project Number: RWW/0012, 13048/6657. Unpublished study prepared by Smithers Viscient Laboratories. 104p.

49020220 Fournier, A. (2012) S

- 1563/Sumith rin WBA (USA) Bulk Formulation

- Acute Toxicity to- Page 48 of 62

- Water Fleas (Daphnia magna) Under Static

- Renewal Conditions. Project Number: RWW/0033/OCR, 13048/6712. Unpublished study prepared by Smithers Viscient Laboratories. 205p.
850.1075 Fish acute toxicity test , freshwater and marine

MRID Citation Reference

49019954 Fournier, A. (2011) S

- 1563

- Acute Toxicity to Bluegill Sunfish (Lepomis macrochirus)

Under Flow

- Through Conditions. Project Number: RWW/0015, 13048/6654. Unpublished study prepared by Smithers Viscient Laboratories. 101p.

49019956 Habig, C. (2012) S

- 1563: Request for a Waiver from Acute Toxicity Testing with

Estuarine and Marine Organisms. Project Number: RWW/0028, 650/02/112012/01. Unpublished study prepared by Compliance Services International. 16p.

49019957 Fournier, A. (2011) S

- 1563

- Acute Toxicity to Fathead Minnow (Pimephales

promelas) Under Flow

- Through Conditions. Project Number: RWW/0014, 13048/6656. Unpublished study prepared by Smithers Viscient Laboratories. 105p.

4901 9959 Fournier, A. (2011) S

- 1563

- Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss)

Under Flow

- Through Conditions. Project Number: RWW/0013, 13048/6655. Unpublished study prepared by Smithers Viscient Laboratories. 108p.

49020222 Fournier, A. (2012) S

- 1563/Sumithrin WBA (USA) Bulk Formulation

- Acute Toxicity

(LC50) with Rainbow Trout (Oncorhynchus mykiss) Under Static

- Renewal Conditions. Project Number: RWW/0026/OCR, 13048/6713. Unpublished study prepared by Smithers Viscient Laboratories. 224p.

850. 1300 Daphnid chronic toxicity test

MRID Citation Reference

49019961 Fournier, A. (2012) S

- 1563

- Full Life Cycle Toxicity Test with Water Fleas (Daphnia

magna) Under Flow

- Through Conditions. Project Number: RWW/0024, 13048/6661. Unpublished study prepared by Smithers Viscient Laboratories. 210p.
850.1400 Fish early

- life stage toxicity test

MRID Citation Reference

49019963 York, D. (2012) S

- 1563

- Early Life

- Stage Toxicity Test with Fathead Minnow,

Pimephales promelas. Project Number: RWW/0021, 13048/6709. Unpublished study prepared by Smithers Viscient Laboratories. 183p.
850.2100 Avian acute oral toxicity test

MRID Citation Reference

49019971 Hubbard, P.; Beavers, J. (2010) S

- 1563: An Acute Oral Toxicity Study with the

Northern Bobwhite. Project Number: RWW/0002, 166/193. Unpublished study prepared by Wildlife International, Ltd. 69p.

49019973 Hubbard, P.; Beavers, J. (2010) S

- 1563: An Acute Oral Toxicity Study with the Zebra

Finch (Poephila guttata). Project Number: RWW/0007, 166/194. Unpublished study prepared by Wildlife International, Ltd. 68p.- Page 49 of 62

- 850.2200 Avian dietary toxicity test

MRID Citation Reference

49019975 Hubbard, P.; Martin, K.; Beavers, J. (2011) S

- 1563: A Dietary LC50 Study with the

Northern Bobwhite. Project Number: RWW/0011, 166/195. Unpublished study prepared by Wildlife International, Ltd. 86p.

49019977 Hubbard, P.; Martin, K.; Beavers, J. (2011) S

- 1563: A Dietary LC50 Study with the

Mallard. Project Number: RWW/0010, 166/196. Unpublished study prepared by Wildlife International, Ltd. 86p.
850.2300 Avian reproduction test

MRID Citation Reference

49019979 Temple, D.; Martin, K.; Beavers, J.; et al. (2012) S

- 1563: A Reproduction Study with

the Northern Bobwhite: Final Report. Project Number: RWW/0019, 166/200. Unpublished study prepared by Wildlife International, Ltd. 223p.

49019981 Temple, D.; Martin, K.; Beavers, J.; et al. (2012) S

- 1563: A Reproduction Study with

the Mallard: Final Report. Project Number: RWW/0020, 166/201. Unpublished st udy prepared by Wildlife International, Ltd. 221p.
850.3030 Honey bee toxicity of residues on foliage

MRID Citation Reference

49020224 Kling, A. (2012) X

- 6935

- 12: Residual Toxicity to the Honey Bee (Apis mellifera L.)

under Extended Laboratory Conditions When Applied as a Foliar Spray to Alfalfa Leaves. Project Number: RWW/0034/OCR, X/6935/12, S12/03547. Unpublished study prepared by Eurofins

- GAB GmbH. 134p.

850.4300 Terrestr ial plants field study

MRID Citation Reference

49020227 Saito, S. (2010) Phytotoxicity Study of S

- 1563 WBA (Wasp & Hornet Insecticide

Aerosol). Project Number: RWW/0005/OCR. Unpublished study prepared by Sumitomo Chemical Co. 19p.
850.4400 Aquatic plant toxicity test using Lemna spp.

MRID Citation Reference

49019988 Softcheck, K. (2012) S

- 1563

- 7

- Day Toxicity Test with Duckweed (Lemna gibba).

Project Number: RWW/0023, 13048/6708. Unpublished study prepared by Smithers Viscient Laboratories. 182p.
850.5400 Algal toxicity

MRID Citation Reference

49019991 Softcheck, K. (2011) S

- 1563

- 96

- Hour Toxicity Test with t h e Freshwater Green Alga,

Pseudokirchneriella subcapita. Project Number: RWW/0018, 13048/6663.- Page 50 of 62

- Unpublished study prepared by Smithers Viscient Laboratories. 153p.- Page 51 of 62

-



### Appendix A . Sumary of Environmental Fate Data for Momflu oro thrin

835.2120 Hydrolysis (MRID 49019941 )

Ponte, M. (2011) Hydrolysis of [(Carbon 14)]S

- 1563 in Buffered Aqueous Solutions. Project

N umber: RWM/0012, 2055W, 2055W/001. Unpublished study prepared by PTRL West, Inc. 309p.

The hydrolysis of [ 14 C]S

- 1563 was studied at pH 4, 7 and 9 incubated at temperatures between 25°C and 60°C. S

1563 was stable to hydrolysis in pH 4 buffers following a preliminary study conducted at 50°C for 5 days. Preliminary hydrolysis studies conducted with S

- 1563RTZ and S

- 1563RTE showed that there were insignificant differences in the hydrolysis rates and degradation pathways for the different isomers. No isomerisation was observed at any of the pH

tested.

In the definitive study

, the hydrolysis of S

- 1563RTZ in pH 7 buffer was conducted at three temperatures, 40, 50 and 60°C for up to 33 days. Similarly, the hydrolysis of S

- 1563RTZ in pH 9 buffer was conducted at three temperatures, 25, 40 and 50°C for up to 21 days. The rate of hydrol ysis of S

- 1563RTZ in pH 7 and pH 9 samples was dependent on temperature and pH.
The major degradates observed were MFOA (96.2% AR in alc

- RTZ

, pH 9 at 50 °C ) and Z

- CMCA (94.1 % AR in acid

RTZ, pH 9 at 40 °C ). The DT 50 at 25 °C were determined to be 381

- 726 days at pH 7 and to be 6.5

- 7.2 days at pH 9

.

835.2130 Aqueous Photolysis (MRID 49019943 ) Ponte, M.; Ponte, V. (2012) Photodegradation of [(Carbon 14)]S

- 1563 in Aqueous Solution Buffered at pH 4 by Artificial Light. Project Number: RWM/0014, 2056W. Unpubl ished study prepared by PTRL West, Inc. 241p.

A photolysis study was conducted with three radiolabels of S

- 1563 in sterile pH 4 buffered solution at 0.3 μg/mL using < 1% acetonitrile as co

- solvent. The average integrated intensity of the light source for the 300

- 400 nm and

300

- 800 nm ranges were 48.6 and 443 W/m 2 , respectively for 13 days. Using the irradiance at wavelengths of 300

- 800 nm during the irradiation period, 10.2 hours of exposure are equivalent to 1 day of natural sunlight (summer

40°N latitud e). Light exposed and dark control samples were maintained at a temperature of 25 ± 2°C. S

- 1563 degraded rapidly in pH 4 buffer solutions when exposed to artificial light and represented approximately 50% AR in the three sets following 13 days of exposure. Appropriate controls confirmed that it was stable to hydrolysis and there was no significant isomerization in darkness. The main degradates observed were CMCA and MFOA via cleavage of the ester linkage. CMCA represented 30.9

- 38.8% AR in the acid label set s with its trace amounts of isomers, and MFOA represented up to an average of 26.6% AR in the alcohol label set by the end of the study period. Isomerization

of S

- 1563RTZ or S

- 1563RTE to the other 7 isomers was observed throughout the study in light expose d samples, but none of the other isomers represented > 4.7% AR. The half

- life of S

- 1563 (sum of eight isomers) in light exposed samples was determined to be 31.7 U.S. solar days (25.9 OECD solar days) for the three sets tested. The photodegradation rates o f S

- 1563 including its photo

- isomerisation were almost the same in S

- 1563RTZ and S

1563RTE with their half

- lives of 17.6 U.S. solar days (14.5 OECD solar days). The quantum yield of S

- 1563 (sum of eight isomers) was determined as 0.0113. The quantum yield of S

- 1563 including its photoisomerization was estimated to be 0.0205, using the photodegradation rate constants for S

- 1563RTZ/S

- 1563RTE (mean 0.0943days

- 1 ).

835.4100 Aerobic soil metabolism (MRID 49019947 )

Ponte, M. (2012) Aerobic Soil Metabolism of [(C arbon 14)]S

- 1563 in Four Soils. Project- Page 52 of 62

-

Number: RWM/0015, 2052W, 2052W/1. Unpublished study prepared by PTRL West, Inc. 555p.

An aerobic soil metabolism study was conducted with three radiolabels : [acid

14 C]S

- 1563RTZ [cyclopropyl

- 1

- 14 C]S

1563RTZ (1 R

- trans

- Z isomer), [alc

14 C]S

- 1563RTZ [methoxybenzyl

- α

14 C]S

- 1563RTZ (1 R

- trans

- Z isomer), and [acid

14 C]S

- 1563RTE [cyclopropyl

- 1

- 14 C]S

- 1563RTE (1 R

- trans

- E isomer) on four agricultural soils

. For the route study, the three radiolabels were applied to individual samples of a Sharkey silt loam soil. For the rate studies, individual samples of HCB loam, APSL sandy loam and APCL clay loam soils were dosed with [acid

14 C]S

- 1563RTZ and [acid

14 C]S

- 1563RTE. The final dose rate for the study was a pproximately 2 μg/g. Samples were incubated at pF 2~2.5 in the dark at 20 °C for up to 122 days. The soil samples were continuously aerated throughout the incubation period. Traps for volatiles included an ethylene glycol trap to collect organic volatiles and 10% aqueo us NaOH traps to collect CO 2 . Soil samples were extracted three times with a neutral solvent (acetone/water, 9/1, v/v) followed by two acidic solvent extractions (acetone/0.5 M HCl, 5/1, v/v) and one acetone

extraction . S

- 1563 and degradates were quantified by reverse phase high performance liquid chromatography (HPLC)

of neutral and acidic soil extracts with co

- injection of a mixed solution of analytical reference standards.

Radiocarbon recoveries were calculated as a percent of applied radiocar bon (AR) and ranged from an a verage of 92.8

± 2.3% to an average of 96.1 ± 6.9% for the all sample sets.

Bound residues for selected samples in the acid

- RTZ and acid

- RTE sets were further characterized by humic acid/fulvic acid partition. Radiocarbon asso ciated with the fulvic acids ranged 1.5% AR to 11.3% AR for all sets,

while radiocarbon associated with the humic acids ranged from 4.9% AR to 11.8% AR for all sets. Radiocarbon remaining bound to the humins represented the biggest portion for all sample s ets and ranged from 15.3% AR to 39.0% AR for all samples tested.

835.1230 Batch Equilibrium, Adsorption/desorption (MRID 49019936)
Ponte, M. (2012) Soil Adsorption/Desorption of [(Carbon 14)]S

- 1563 by the Batch Equilibrium Method. Project Number: RWM/0016, 2059W, 2059W/1. Unpublished study prepared by PTRL West, Inc. 315p.

Adsorption and desorption of [ 14 C]S

- 1563RTZ was studied on four soils and one sediment using the batch equilibrium method (pH (CaCl 2 ) range 5.65 to 7.3, %OC 0.32

– 4.0)

. Isomeri sation was determined and showed that it was insignificant during the experiment. No significant difference in adsorption/desorption behaviour

between the RTZ and RTE isomer was observed in the preliminary studies and therefore the definitive study was

con ducted with the RTZ isomer only. Adsorption K ads (K f ) values ranged from 4.85 to 42.5. K OC values ranged from 1033 to 4344 (average = 1748, n=5). These K OC values show that S

- 1563RTZ has a low mobility.
Desorption K des values ranged from 9.03 to 53.5. The K OC values for desorption ranged from 1085 to 6219 (average = 2484, n=5), indicating that once adsorbed to the soil S

- 1563RTZ is not likely to be removed

. There was no evidence of any pH dependence.

835.4300 Aerobic Aquatic Metabolism (MRID 49019949)

Ponte, M.; Mannella, L. (2011) [(Carbon 14)]S

- 1563: Degradation in Water Sediment System under Aerobic Conditions. Project Number: RWM/0011, 2054W, 2054W/1. Unpublished study prepared by PTRL West, Inc. 385p.- Page 53 of 62

-

An aerobic aquatic metabolism study was cond ucted with three radiolabels of [ 14 C]S

- 1563 applied to two freshly collected sediment/water systems (Abbey and Swiss) per radiolabel. The radiolabels included [acid

14 C]S

- 1563RTZ [cyclopropyl

- 1

- 14 C]S

- 1563RTZ (1 R

- trans

- Z isomer), [alc

14 C]S

- 1563RTZ [methoxybenzyl

- α

14 C]S

- 1563RTZ (1 R

trans

- Z isomer), and [acid

14 C]S

- 1563RTE [cyclopropyl

- 1

- 14 C]S

- 1563RTE (1 R

- trans

- E isomer). Individual sediment/water samples were treated with [ 14 C]S

- 1563 with 7.7

- 8.4 μg per sample for both test systems and incubated

und er aerobic conditions at 20 ± 2 °C in the dark . All samples were then incubated for up to 105 days for [acid

14 C]S

1563RTZ and [acid

14 C]S

- 1563RTE samples and 146 days for [alc

14 C]S

- 1563RTZ samples. [ 14 C]S

- 1563 degraded rapidly in both test systems throug hout the study period and represented < 4% AR after 8 days of incubation. DT 50 and DT 90 values were calculated as < 3 days and < 10 days respectively. Likewise, the rate of dissipation of [ 14 C]S

1563 was rapid in the water layer representing < 3 days for D T 50 and < 9 days for DT 90

. The main degradates of [alc

14 C]S

- 1563RTZ were MFOA

- D (maximum of 72.9% of AR at day 100 in Abbey and 74.5% at day 15 in Swiss) and TFPA detected in both test systems (10.5% AR in Abbey at day 100 and 67.5% in Swiss at the end of incubation period) and MFOA detected in Abbey test syste m only >10% AR (35% at day 8). Other degradates observed during the incubation period were S

- 1563RTZ

- CONH 2

. The primary degradates of [acid

14 C]S

- 1563RTZ were Z

- CMCA (83.7% at day 8 in Abbey and 72% at day 8 in Swiss) followed by ωc

- CONH 2 - d

- t

- CRA and t

- COO H

- CA (max. averages of 21.0% AR (Swiss, day 100) and 10.3% AR (Abbey, day 58 )) . S

- 1563RTZ

- CONH 2 was observed at levels of 8%. E

- CMCA represented the main degradate of [acid

14 C]S

- 1563RTE, with maximum averages of 64.3 % AR at day 7 in Abbey and 59.8% AR at day 30 in Swiss, followed by two other important degradates, ωt

- CONH 2 - d

- t

- CRA and t

- COOH

- CA (max. average of 31.7% and 26.1% after 100 days in Swiss and 20.1% and 21.5% AR respectively at day 59 in Abbey). Other minor degradates

observed were S

- 1563RTE

- C ONH 2 and ωt

- COOH

- d

- t

- CRA.

No isomerisation was observed for S

- 1563RTZ and RTE

850.1730 Fish BCF (MRID 49019966)

Kang, S. (2012) Flow

- Through Biocencentration and Metabolism Study of [(Carbon 14)]S

1563 with Bluegill sunfish (Lepomis macrochirus). Project Number: RWW/0025, 13048/6668. Unpublished study prepared by Smithers Viscient Laboratories. 238p.

The bioconcentration potential of S

- 1563 to bluegill sunfish was evaluated using [Benzyl

14 C]S

- 1563 which consists of two geometrical isomers, S

- 1563RTE and S

- 1563RTZ. The study was conducted to measure the uptake and depuration of S

- 1563 and steady

- state bio concentration factor (BCF). Bluegill sunfish were exposed to [Benzyl

14 C]S

- 1563 using a flow

- through system, at concentrations of 0.1 and 0.3 μg a.s./L. Fish were exposed to the test concentrations for a total of 35 days. For the elimination of [ 14 C ] res idues (depuration), the test fish were placed in clean water for 28 days. The major findings of the study are as follows.

 A steady state was reached by exposure Day 35.

 S

- 1563 was stable in water; however, rapidly metabolized in fish and was not detected a fter exposure Day 1.

 The depuration half

- life for [ 14 C]residue s was approximately 9.8 and 12 days in the low and high concentration levels, respectively.

 The steady

- state bioconcentration factors based on the measured [ 14 C]residue concentrations for the w hol e fish were 612 and 600 in the low and high concentration fish, respectively

.- Page 54 of 62

-



### Appendix B . Sumary of Ecological Effects Data for Momflu oro thrin

Table 1. Summary of Submitted Aquatic Toxicity St udies f or Momfluorothrin

.

Exposure Scenario Species Exposure
Duration Toxicity Reference

Value Effects Reference / Study Classification /
Formulation Toxicity Category

Freshwater Fish

Acute Rainbow trout

( Oncorhynchus mykiss ) 96 hours LC 50 = 1.2 μg a.i./L Mortality MRID 49019959 Acceptable

TGAI Very Highly Toxic

Acute Rainbow trout

( O

. mykiss ) 96 hours LC 50 = 1 .3 μg a.i./L Mortality MRID 490 20222 Supplemental

F ormulated product (0.12 % a.i.) Very Highly Toxic

Acute Bluegill sunfish

( Lepomis
macrochirus ) 96 hours LC 50 = 3.0 μg a.i./L Mortality MRID 490199 54 Acceptable

TGAI Very Highly Toxic

Acute Fathead minnow

( Pimephales promelas ) 96 hours LC 50 = 7.6 μg a.i./L Mortality MRID 490199 57 Supplemental

TGAI Very Highly Toxic

Chronic Fathead minnow

( P

. promelas ) 32 days NOAEC = 3.1 μg a.i./L LOAEC = >3.1 μg ai/L No effects on survival and growth MRID 49019963

Acceptable

TGAI Not Applicable

Freshwater Invertebrates

Acute Water flea

( Daphnia magna ) 48 hours EC 50 = 7.8 μg a.i./L Mortality MRID 49019952 Acceptable

TGAI Very Highly Toxic- Page 55 of 62

- Table 1. Summary of Submitted Aquatic Toxicity St udies f or Momfluorothrin

.

Exposure Scenario Species Exposure
Duration Toxicity Reference

Value Effects Reference / Study Classification /
Formulation Toxicity Category

Acute Water flea

( D

. magna ) 48 hours EC 50 = 16.5 μg a.i./L Mortality MRID 490 20220 Supplemental Formulated product (0.12% a.i.) Very Highly Toxic

Chronic Water flea

( D

. magna ) 21 days NOAEC = 3.1 μg a.i./L

LOAEC = 9

. 3 μg ai/L Growth and reproduction MRID 49019961 Acceptable

TGAI Not Applicable

Benthic Organisms

Chronic Midge ( Chironomus

dilutus ) 49 days NOAEC < 13 μ g a.i./kg
sediment (1.8 μg a.i./L pore water)
LOAEC = 13 μ g a.i./kg
sediment Mortality and Growth MRID 49019968
Supplemental, for qualitative use only

TGAI Not Applicable

Aquatic Plants Duckweed ( Lemna gibba ) 7 days IC 50 > 2,500 μg a.i./L

NOAEC = 2,500 μg a.i./L No toxicity MRID 49019988 Supplemental

TGAI Toxicity categories

are not specified for plants

Green algae ( Pseudokirchneriella subcapitata ) 96 hours IC 50 : Could not be

determined NOAEC: 370 μg a.i./L Potential interference

from co

- solvent confounds interpretation of treatment responses MRID 49019991 Supplemental, for

qu alitative use only

TGAI Toxicity categories are not specified for plants

Note: No data available for estuarine/marine fish and invertebrates- Page 56 of 62

- Table 2. Summary of Submitted Terrestrial Toxicity Studies f or Momfluorothrin

.

Exposure Scenario Species Exposure
Duration Toxicity Reference

Value Effects Reference / Study Classification /
Formulation Toxicity Category

Birds

Acute Oral Dose Bobwhite quail ( Colinus virginianus ) 14 day

observation period LD 50 >2,250 mg a.i./kg

bw Mortality MRID 49019971 Acceptable

TGAI Practically non

toxic

Acute Oral Dose

Zebra finch

( Poephila guttata ) 14 day

observation period LD 50 > 2,250 mg a.i./kg

- bw Mortality MRID 490 19973 Supplemental

TGAI Practically non

toxic

Acute Dietary Bobwhite quail ( C

.

virginianus ) 5 day exposure, 3

day post

- exposure observation LC 50 >5,620 mg a.i./kg

diet Mortality MRID 490199 75 Acceptable

TGAI Practically non

toxic

Acute Dietary Mallard duck

( A. platyrhynchos ) 5 day exposure, 3

day post

- exposure observation LC 50 > 5,620 mg a.i./kg

diet Mortality MRID 490199 77 Supplemental

TGAI Practically non

toxic

Chronic Bobwhite quail ( C

.

virginianus ) 20 weeks NOAEC < 241 mg a.i./kg diet LOAEC = 241 mg a.i./kg diet Adult female weight gain MRID 49019979

Supplemental

TGAI Not Applicable

Chronic Mallard duck

( A. platyrhynchos ) 20 weeks NOAEC = 483 mg a.i./kg

- diet LOAEC = 992 mg a.i./kg

- diet Eggs laid MRID 49019981 Acceptable

TGAI Not Applicable

Mammals

Acute Oral Dose Laboratory Rat

( R attus norvegicus ) 14 day

observation period LD 50 > 2,000 mg a.i./kg

bw Mortality MRID 490 20096 Acceptable
15.5% a.i. Practically non

toxic- Page 57 of 62

- Table 2. Summary of Submitted Terrestrial Toxicity Studies f or Momfluorothrin

.

Exposure Scenario Species Exposure
Duration Toxicity Reference

Value Effects Reference / Study Classification /
Formulation Toxicity Category

Acute Inhalation Laboratory Rat

( R

. norvegicus ) 4 hours LC 50 > 1.03 mg/L Mortality MRID 490 20103 Acceptable
15.5% a.i. Practically non

toxic

Chronic Laboratory Rat

( R

. norvegicus ) 90 days NOAEC = 200 mg a.i./kg diet LOAEC = 500 mg a.i./kg diet Decreased F1 and F2 pup weight MRID 49020018

Acceptable

TGAI Not Applicable

Terrestrial invertebrates

Acute Honey bee

( Apis mellifera L. ) 48 hours Contact LD 50 = 0.2 μg

a.i./bee Mortality MRID 4901 9985
Acceptable

TGAI Highly toxic

Oral LD 50 = 5.08 μg

a.i./bee Mortality MRID 4901 9985
Acceptable

TGAI Not Applicable

3

– 24 hours RT 25 < 3 hours Mortality MRID 490 20224
Supplemental Formulated product (0.102% a.i.) Not Applicable- Page 58 of 62

- Table 2. Summary of Submitted Terrestrial Toxicity Studies f or Momfluorothrin

.

Exposure Scenario Species Exposure
Duration Toxicity Reference

Value Effects Reference / Study Classification /
Formulation Toxicity Category

Sub Acute Earthworm ( Eisenia

fetida ) 14 days LC 50 = 97.6 mg a.i./kg soil dry weight NOAEC = 15.6 mg a.i./kg soil dry weight LOAEC = 31.3 mg a.i./kg soil dry weight Body weight change MRID 49019983 Supplemental

TGAI Not Applicable

Terrestrial Plants Wheat ( Triticum aestivum )

, Cucumber ( Cucumis sativus ), Cabbage ( Brassica

oleracea ), and Tomato ( Lycopersicon
esculentum ) 21 days Not Applicable Plant length, dry weight, necrotic area, germination MRID 49020227 Supplemental Formulated product (0.1 % a.i.) Toxicity categories are not specified for plants- Page 59 of 62

-

Appendix C . Model Outputs

SIP Model Outputs

Table 1. Inputs

Parameter Value

Chemical name m omfluorothrin
Solubility (in water at 25 o C; mg/L) 0.933

Mammalian LD 50 (mg/kg

- bw) 2000 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

- bw) 10 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg

- bw) 2250 Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) 483 Bobwhite quail NOAEC (mg/kg

- diet) 241 NOAEC (mg/kg

- diet) for other bird species Body weight (g) of other avian species NOAEC (mg/kg

- diet) for 2nd other bird species Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 0.1605 0.1605 Adjusted toxicity value (mg/kg

- bw) 1538.3211 7.6916 Ratio of exposure to toxicity 0.0001 0.0209

Conclusion* Drinking water exposure alone is NOT a potential
concern for mammals Drinking water exposure alone is NOT a potential
concern for mammals- Page 60 of 62

-

Table 3. Avian Results

Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 0.7557 0.7557 Adjusted toxicity value (mg/kg

- bw) 1620.9664 23.9629 Ratio of exposure to acute toxicity 0.0005 0.0315

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 Model Outputs



## Input

Application and Chemical Information

Enter Chemical Name momfluorothrin

Enter Chemical Use aerosol spray Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 385.35 Enter Chemical Vapor Pressure (mmHg) 1.04E

- 08 Enter Application Rate (lb a.i./acre)

Toxicity Properties

Bird

Enter Lowest Bird Oral LD 50 (mg/kg bw) 2250 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178

Mammal

Enter Lowest Rat Oral LD 50 (mg/kg bw) 2000

Enter Lowest Rat Inhalation LC 50 (mg/L) 1.03 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35



## Output

Results Avian (0.020 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.16E

- 04

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 2.71E

- 05

Adjusted Inhalation LD 50 6.46E+00

Ratio of Vapor Dose to Adjusted Inhalation LD 50 4.20E

- 06 Exposure not Likely Significant- Page 61 of 62

-

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 0.00E+00 Ratio of Droplet Inhalation Dose to Adjusted Inhalation
LD 50 0.00E+00 Exposure not Likely Significant

Results Mammalian (0.015 kg )
Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 2.16E

- 04

Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 3.41E

- 05

Adjusted Inhalation LD 50 6.13E+01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 5.56E

- 07 Exposure not Likely Significant

Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 0.00E+00 Ratio of Droplet Inhalation Dose to Adjusted Inhalation
LD 50 0.00E+00 Exposure not Likely Significant

T

- REX Model Output for Mammalian Exposure

Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Momfluorothrin

Use Aerosol Spray

Formulation 0
Application Rate 0.9 lbs a.i./acre

Half

- life 35 days
Application Interval 0 days
Maximum # Apps./Year 1
Length of Simulation 1 year Variable application rates? no



## Dietary

- based EECs (ppm) Kenaga

Values

Short Grass 216.00

Tall Grass 99.00 Broadleaf plants 121.50 Fruits/pods/seeds 13.50
Arthropods 84.60



## Dose

- based EECs

(mg/kg

- bw) Avian Classes and Body Weights (grams)

small mid large

20 100 1000

Short Grass 246.00 140.28 62.81

Tall Grass 112.75 64.30 28.79 Broadleaf plants 138.38 78.91 35.33 Fruits/pods 15.38 8.77 3.93 Arthropods 96.35 54.94 24.60

Seeds 3.42 1.95 0.87- Page 62 of 62

- Table X. Upper Bound Kenaga, Chronic Mammalian Dose

- Based Risk Quotients

Size Class (grams) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf

Plants Fruits/Pods/Seeds Arthropods Granivore

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 21.98 20 5.94 9.37 94.39 4.29 115.84 5.27 12.87 0.59 80.66 3.67 2.86 0.13

35 17.78 142.33 8.00 65.24 3.67 80.06 4.50 8.90 0.50 55.75 3.13 1.98 0.11

1000 7.69 33.00 4.29 15.13 1.97 18.56 2.41 2.06 0.27 12.93 1.68 0.46 0.06

T

- REX Model output for avian exposure following dispersal of entire 7 oz can’s contents

onto a 200 ft 2 area.

Upper Bound Kenaga Residues For RQ Calculation

Chemical Name: Momfluorothrin

Use 0

Formulation 0
Application Rate 0.09 lbs a.i./acre

Half

- life 35 days
Application Interval 0 days
Maximum # Apps./Year 1
Length of Simulation 1 year Variable application rates? no



## Dietary

- based EECs (ppm) Kenaga

Values

Short Grass 21.60

Tall Grass 9.90 Broadleaf plants 12.15 Fruits/pods/seeds 1.35
Arthropods 8.46