# Environmental Fate and Ecological Risk Assessment for the

Registration of the New Chemical Fluensulfone

Fluensulfone

CAS : 318290-98 -1 PC Code: 050410

Prepared by: Donna Reed Judkins, Ph.D., Biologist James Lin, Ph.D., Environmental Engineer U.S. Environmental Protection Agency Office of Pesticide Programs

Environmental Fate and Effects Division

Environmental Risk Branch I I 1200 Pennsylvania Ave., NW

Mail Code 7507P Washington, DC 20460 Reviewed by:

Christine Seeible Hartless, Ph.D., Wildlife Biologist Greg Orrick, Environmental Scientist Jean Holmes, DVM, Risk Assessment Process Leader Brian Anderson, Branch Chief-Page 2 of 117- 

### Table of Contents

1. Executive Summary

................................ ............................................................................................................. 4

1.1. Nature of Chemical Stressor

................................ ....................................................................................... 4

1.2. Exposure Characterization

................................ .......................................................................................... 4

1.3. Effects Characterization

................................ ............................................................................................. 5 1.4. Potential Risks to Non-target Organisms

.................................................................................................... 6

1.5. Data Gaps and Uncertainties

................................ ...................................................................................... 7

2. Problem Formulation

................................ ................................................................................................................ 8

2.1. Nature of Regulatory Action

................................ ...................................................................................... 8

2.2. Stressor Source and Distribution

................................................................................................................ 8

2.2.1. Nature of the Chemical Stressor

.......................................................................................................... 8 2.3. Receptors

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

2.3.1. Aquatic and Terrestrial Effects

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

2.3.2. Ecosystems Potentially at Risk

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

2.4. Assessment Endpoints

................................ .............................................................................................. 10 2.5. Conceptual Model

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

2.5.1. Risk Hypotheses

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

2.5.2. Conceptual Diagram

................................ .......................................................................................... 11 2.6. Analysis Plan

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

2.6.1. Residues of Concern

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

2.6.2. Measures of Exposure

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

2.6. 3. Measures of Effect

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

2.6.4. Integration of Exposure and Effects

.................................................................................................. 14 3. Analysis

................................ ................................ .................................................................................................. 15

3.1. Use Characterization

................................ ................................................................................................ . 15

3.2. Exposure Characterization

................................ ........................................................................................ 15

3.2.1. Environmental Fate and Transport Characterization

................................ ......................................... 15 3.2.1.1. Transport and Mobility

................................ .................................................................................... 16 3.2.1.2. Degradation

................................ ..................................................................................................... 17

3.2.1.3. Field Studies

................................ .................................................................................................... 17 3.2.1.4. Environmental Degradates

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

3.2.2. Measures of Aquatic Exposure

.......................................................................................................... 20 3.2.2.1. Surface Water Exposure

................................ .................................................................................. 20 3.2.2.2. Spray Drift Only Exposure

.............................................................................................................. 24 3.2.2.3. Aquatic Bioaccumulation

................................................................................................................ 25

3.2.3. Measures of Terrestrial Exposure

...................................................................................................... 25

3.2.3.1. Terrestrial Wildlife

................................ .......................................................................................... 25

3.2.3.2. Sub-terrestrial Animals

................................ .................................................................................... 26

3.2.3.3. Terrestrial Plants

................................ .............................................................................................. 26

3.3. Ecological Effects Characterization

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

3.3.1. Aquatic Toxicity Characterization

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

3.3.1.1. Toxicity to Freshwater Fish

..................................................................................................... 29

3.3.1.2. Toxicity to Freshwater Invertebrates

....................................................................................... 31

3.3.1.3. Toxicity to Estuarine/Marine Fish

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

3.3.1.4. Toxicity to Estuarine/Marine Invertebrates

................................ ............................................. 35

3.3.1.5. Toxicity to Aquatic Plants

....................................................................................................... 36

3.3.2 Terrestrial Effects Characterization

................................................................................................... 39

3.3.2.1. Toxicity to Birds

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

3.3.2.2. Toxicity to Mammals

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

3.3.2.3. Toxicity to Terrestrial Invertebrates and Beneficial Insects

.................................................... 47

3.3.2.4. Toxicity to Terrestrial Plants

................................................................................................... 50-Page 3 of 117-

4. Risk Characterization

................................ ......................................................................................................... 54

4.1 Risk Estimation

................................ ........................................................................................................ 54

4.1.1. Aquatic Organisms

................................ ............................................................................................ 54

4.1.1.1. Aquatic Animals

................................ ...................................................................................... 54

4.1.1.2. Aquatic Plants

................................ .......................................................................................... 56

4.1.2. Terrestrial Organisms

................................ ........................................................................................ 57

4.1.2.1. Birds

................................ ......................................................................................................... 58

4.1.2.2. Mammals

................................ ................................................................................................ . 59

4.1.2.3. Terrestrial Invertebrates

........................................................................................................... 59

4.1.2.4. Terrestrial Plants

................................ ...................................................................................... 60

4.2. Risk Description

................................ ....................................................................................................... 60

4.2.1. Ris ks to Aquatic Organisms

.............................................................................................................. 61

4.2.1.1. Risks to Aquatic Animals

........................................................................................................ 61

4.2.1.2. Risks to Aquatic Plants

............................................................................................................ 61

4.2.2. Risks to Terrestrial Organisms

.......................................................................................................... 61 4.2.2.1. Birds, Terrestrial-Phase Amphibians and Reptiles

................................ ........................................... 61

4.2.2.2. Mammals

................................ .......................................................................................................... 62

4.2.2.3. Terrestrial Invertebrates

................................ .................................................................................... 63

4.2.2.4. Terrestrial Plants

................................ ............................................................................................... 64

5. Federally Threatened and Endangered (Listed) Species Concerns

................................ .................................... 64

5.1. Action Area

................................ .............................................................................................................. 65

5.2. Taxonomic Groups Potentially at Risk

..................................................................................................... 65

5.2.1. Probit Dose-Response Analysis

........................................................................................................ 67

5.2.2. Conclusions, Uncertainties and Potential Reduction Measures

......................................................... 68

5.2.3. Listed Species Occurrence Associated with Fluensulfone Use

......................................................... 70

6. References

................................ ................................ .......................................................................................... 71

6.1. Submitted Product Chemistry and Environmental Fate Studies

............................................................... 72

6.2. Submitted Ecotoxicity Studies

................................ .................................................................................. 74 Appendix A. Aquatic Model Input/Output Data.

........................................................................................................ 83 Appendix B. AGDRIFT v.2.01 Output.

................................ ...................................................................................... 87 Appendix C. T-REX and Terrplant Output for Fluensulfone.

.................................................................................... 97 Appendix D. Earthworm Fugacity Model

................................ ................................................................................ 100 Appendix E. TerrPlant Output

................................ .................................................................................................. 105 Appendix F. Fluensulfone Degradate Toxicity Summary.

....................................................................................... 106 Appendix G. Submitted Ecological Effects Studies for Fluensulfone and Remaining Data Gaps.

.......................... 111-Page 4 of 117-



# 1. Executive Summary

1.1. Nature of Chemical Stressor

Fluens ulfone ( i.e.

, 5-chloro -1,3 -thiazol-2 -yl 3,4,4-trifluorobut-3- en

- 1 -yl sulfone or 5- chloro-2-[(3,4,4-trifluoro -3 -buten-1 -yl)sulfonyl]thiazole; CAS: 318290- 98 -1 ), is a pyrazole nematicide used mainly to control root-knot ( Mel oidogyne spp.) and lesion nematodes ( Pratylenchu s spp.) on transplanted crops. The compound is moderately mobile in soil, and is

not e xpected to bioaccumulate in fish . Fluensulfone is proposed for use on transplanted crops

for c ucurbit vegetables - crop group 9 includes cucumbers, melons, (cantaloupes, watermelon, honeydew) squash; and fruiting vegetables - crop group 8 includes bell pepper, eggplant, groundcherry, hot pepper, pepino, pepper (except black), pimento, sweet pepper, tomatilo, and

tom atoes for processing.

One end-use formulation of fluensulfone is proposed for registration in the United States, Fluensulfone 480EC, an emulsifiable concentrate containing 40% fluensulfone active ingredient, (a .i.). The label-recommended single application rates for proposed U.S. registration are 1.75 to 3.5 lb a.i./A, with a minimum delay of seven days before transplanting. Only one application is

al lowed annually, with a maximum annual application rate of 3.5 lb a.i./A per year for all

propos ed crops. The proposed crops are cucurbit vegetables, which include cucumbers, melons, (c antaloupes, watermelon, honeydew) squash; and fruiting vegetables, which include bell

pepper , eggplant, groundcherry, hot pepper, pepino, pepper (except black), pimento, sweet pepper, tomatilo, and tomatoes for processing. No aerial applications are allowed. Applications can be broadcast incorporated, banded and incorporated, or applied by drip irrigation.

1.2. Exposure Characterization

Fluensulfone is not expected to volatilize from water or moist soil but may volatilize in dry fiel d conditions. It is moderately mobile in soil Fluensulfone does not undergo hydrolysis. Aqueous photol ysis is the fastest route of fluensulfone degradation (half-lives of 0.58 and 0.68 days). The compound persists in anaerobic soil with a long half-life of 397 days, compared with the half-life range of 8 to 15 days for aerobic soil. For aquatic systems, the aerobic metabolism half-life ranged from 39 to 42 days, and the anaerobic metabolism half-life ranged from 23 to 26 days. Terrestrial field dissipation study results are relatively consistent with those of the laboratory studies, showing that fluensulfone’s dissipation half-lives range from 7.4 to 10.8 days (laboratory aerobic soil metabolism study half-lives ranged from 8 to 15 days). Fluensulfone has an octanol-water partition coefficient (K OW 

### ) of 91.2, for this reason, the fish bioaccumulation study is not required.

Major identified environmental degradates of fluensulfone are thiazole sulfonic acid (TSA), methyl sulfone (MS), and butene sulfonic acid (BSA) in soils. In aquatic systems, the major degradates included MS, deschloro-fluensulfone, BSA, and butene sulfinic acid. Deschloro-fluensulfone, butene sulfinic acid, and deschloro thiazole sulfonic acid (a minor degradate) were only detected in an aquatic study. The chemical structures of these degradates are provided in Table 3.3 ).-Page 5 of 117-



### To model aquatic exposure, the total toxic residues (TTR) approach was used to combine the parent fluensulfone and the most toxic degradate, MS.

1.3. Effects Characterization

Fluensulfone is classified as moderately toxic to freshwater and estuarine/marine fish

, highly toxic to both freshwater and estuarine/marine invertebrates, and very highly toxic to molluscs on an acute exposure basis (based on reduced shell deposition). Mortality and sublethal effects were observed in most of the acute aquatic animal studies for fluensulfone.

The available acute toxicity data for the 480EC formulation, which contains 40 %

fluensul fone a.i., show that it is approximately 5- 12 times more toxic to fish, 58x more toxic to aquatic invertebrates, 2x more toxic to algae, 3-6x more toxic to earthworms, and 2x more toxic

to birds than the fluensulfone a.i. alone. All available aquatic toxicity data show that metabolites

of fluensulfone are less toxic to aquatic animals and plants than the parent fluensulfone, with the possi ble exception of MS, which may be of similar toxicity to the parent compound.

Fluens ulfone is classified as slightly toxic to avian species on an acute oral and

pra ctically non-toxic on a subacute dietary-exposure basis; however, treatment-related regurgitation was observed in canaries dosed with fluensulfone technical active ingredient (TGAI)

. The lowest no observed adverse effect (dietary) concentration ( NOAEC ) in an avian reproduction study ( 255 mg a.i./kg diet) was based on a growth inhibition in mallard ducks.

F luensulfon e is classified as low to moderately toxic to mammals on an acute oral exposure basis. A two

- generation reproduction study o f rats resulted in a no observed adverse effect level (NOAEL) of 16.2 mg a.i./kg

- bw/day (250 ppm) based on reduced parent and pup w eights, inhibited weight gain and feed consumption, increased liver and kidney weight s, histopathology changes in the liver and kidney and increased post

- natal pup loss.

Based on available data, fluensulfone is classified as practically non-toxic to the honeybee . Fluensulfone effects on terrestrial invertebrates tested included mortality, weight loss and reproduction impairment, with the 480EC formulation being about twice as toxic as the

TGAI to the honeybee (although the TGAI data was not definitive) and earthworm. Adverse effects are possible on terrestrial invertebrates, including pollinators and beneficial insects, from

exposur e to the formulated product in the use areas. Exposure is esp e cially expected forearthworms and other under-ground invertebrates due to the mandatory incorporation or dripirrigation into the soil. Other invertebrates may be exposed if present in patches between furrows where incorporation does not occur, or alongside in areas reached by spray drift.

Results of the Tier II seedling emergence and vegetative vigor studies with the 480E C

formulation show significant effects on onion, ryegrass, cabbage, soybean, wheat and radish.

The most sensitive monocots were on ion and wheat . The most sensitive dicots were cabbage and soybean.-Page 6 of 117-



### 1.4. Potential Risks to Non-target Organisms

According to this screening-level ecological risk assessment, the proposed use of

fluensulfone for nematode control on selected cucurbit and fruiting vegetable crops results in

LOC exceedances for birds, mammals, aquatic and terrestrial invertebrates, and aquatic plants.

Additi onally, passerine risk could not be fully assessed due to inadequate data; risk to this group is uncertain since they can be more sensitive than other test species.

Potential indirect effects may also occur, including, but not limited to, reduction in food

re sources, decrease in cover, change in water quality parameters, and loss of breeding/nesting habitat. Identified potential direct and indirect risks to listed species that may result from the proposed uses of fluensulfone are summarized in Tab le 1.1. In addition, it is possible that adverse effects to terrestrial invertebrates, including pollinators and beneficial insects, may

occur , based on exposure to the 480EC formulated products in and around the use areas of the

propos ed uses of fluensulfone.

Tab le 1.1. Potent ial Direct and Indirect Effects to Federally Listed Taxa from Proposed

Use of Fluensulfone to Control Nematodes on Cucurbit and Fruiting Vegetable Crops.

Listed Taxon Direct Effects Uses of Concern Indirect

Effects c Uses of Concern

Terrestrial and semi

- aquatic plants

- monocots No None No None

Terrestrial and semi

- aquatic plants

- dicots Yes All uses No None

Birds Yes All uses Yes 1,2 ,3 All uses

Terrestrial

- phase amphibians Yes All uses Yes 1,2 ,3 All uses Reptiles Yes All uses Yes 1,2 ,3 All uses

Mammals Yes All uses Yes 1,2 ,3 All uses

Terrestrial invertebrates Yes a All uses Yes 1 ,3 All uses Aquatic vascular and non

vascular plants Yes All uses No None

Freshwater fish No None Yes 2

, 4 All uses Aquatic

- phase amphibians No None Yes 2

, 4 All uses

Freshwater invertebrates No All uses Yes 2

, 4 All uses

Freshwater m ollusks Yes b All uses Yes 2

, 4 All uses

Marine/estuarine fish No None Yes 2

, 4 All uses

Marine/estuarine invertebrates No All uses Yes 2

, 4 All uses

Marine/estuarine m olluscs Yes b All uses Yes 2

, 4 All uses

Sediment

- dwelling organisms No None Yes 2

, 4 All uses

a The LOC exceedance was based on lines of evidence including application rate, toxicity data (both pollinators and beneficial insects), and the mode of action of fluensulfone.

b Based on exposure from spray drift.

c Potential indirect effects on a taxon attributable to:

1 Direct acute and chronic effects on birds and mammals.

2 Direct acute and chronic effects on aquatic invertebrates.

3 Direct effects to terrestrial plants (dicots).

4 Direct effects to aquatic plants.-Page 7 of 117-



### Potential measures identified that would reduce environmental exposure or toxicity

inc lude:

re -formulation of the end-use product to bring down the formulated product toxicity, label specifications for boom height and droplet size, and label specifications of a buffer zone.

For reduction of LOC exceedences based on exposure from spray drift, an estimated 3 to

49 fo ot buffer would be needed to remove the presumption of risk to aquatic organisms (see

Table 5.2 ). Specifying a low boom and larger droplet size is also a feasible way to reduce risk

and r educe the size of a protective buffer for aquatic organisms (also see Appendix B ):

3 foot buffer would protect aquatic plants 1 

### using high boom and fine droplets; no LOCs were exceeded with low boom and/or larger droplet sizes; 49 foot buffer would protect molluscs using high boom and fine droplets; 3 foot buffer if low boom used, and no buffer if coarse droplet size used.

For terrestrial organisms, concern levels are exceeded up to approximately 70 feet from the site of application.

1.5. Data Gaps and Uncertainties

Data gaps and uncertainties found in this assessment include:

data gap in toxicity to passerine bird species; the results of the available avian acute oral data are not adequate to assess risk to passerines and rough estimates may

under- or over-estimate the risk; potential for exposure of avian, reptilian, amphibious or mammalian consumers of

seeds and terrestrial invertebrates in the treatment area is evaluated but the amount of seeds and invertebrates entering the treatment area is an unknown and so the rough estimates may under- or over-estimate the risk to consumers; and degree of above-ground vs. under-ground exposure to terrestrial invertebrates entering the treatment area is an unknown and so the rough estimates may under- or

over -estimate the risk.

At the time of this assessment, some uncertainty was attributed to the degree of exposure to terrestrial organisms in and around the treatment area due to proposed label ambiguities on

aer ial application and time limit for incorporation. However, EFED understands that these label ambiguities will be corrected and, therefore, conducted this assessment assuming no aerial application and immediate incorporation with an important caveat that without these corrections,

thi s risk assessment will underestimate risks. For terrestrial exposure, the only areas assumed to

1 The listed-species LOC was exceeded for non-vascular aquatic plants. However, no aquatic non-vascular plants are presently listed as endangered or threatened species in the US.-Page 8 of 117-



### be exposed were areas receiving spray drift and between-furrow and peripheral areas where the

spr ayed area was wider than the incorporated area, and where puddles occur from drip irrigation.



# 2. Problem Formulation

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

fluensulfone. This problem formulation sets the objectives for the risk assessment, establishes a risk hypothesis and conceptual model depicting risk, and provides a plan for analyzing the data and characterizing the risk associated with the proposed uses of fluensulfone (U SEPA, 1998a).

2.1. Nature of Regulatory Action

This as sessment was prepared to support the new chemical registration of fluensulfone.

As a new fungicide being proposed for use in the United States, the U.S. Environmental Protection Agency (EPA or the Agency) is required under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to ensure that fluensulfone does not have the potential to cause

unre asonable 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) are also considered under the Endangered Species Act (ESA) in order to ensure that the registration of fluensulfone is not likely to jeopardize the continued existence of

such l isted 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

ass essments (USEPA, 1998a) and Office of Pesticide Program’s Overview Document, which

cont ains 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 product label. The label is a legal document that stipulates how and where a given pesticide may be used. Product labels (also known as end-use labels) describe the

for mulation 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, described by the pesticide’s labels is considered “the action” being assessed.

2.2. Stressor Source and Distribution

2.2. 1. Nature of the Chemical Stressor

Fluensulfone belongs to the fluoroalkenyle chemical class. It is a pyrazole nematicide used mainly to control root-knot ( Mel oidogyne spp.) and lesion nematodes ( Pratylenchus spp.) on transplanted crops. The mode of action of fluensulfone is distinct from that of

orga nophosphates, carbamates and avermectins. Fluensulfone has a pleiotropic expression of activity against nematodes, including weak inhibition of motility in adults, strong inhibition of motility in larvae, feeding inhibition and egg-laying, hatching and developmental inhibition.-Page 9 of 117-



### Inhibition of larval thrashing and feeding is irreversible after 24 hours of exposure and the cuticle does not appear to present a barrier to access.

Makhteshim Agan of North America, Inc. is applying to register fluensulfone in the United States as a technical grade active ingredient (TGAI) and in formulated end-use product, respectively. The end-use product currently proposed for registration in the United States is

fluensul fone 480 EC, which is to be for use on cucurbits and fruiting vegetables under outdoor conditions. The proposed use methods include broadcast, banded, and drip irrigation applications followed by either mechanical soil incorporation (broadcast, banded ) or delivery via water (drip irrigation) to a 6-inch depth at the maximum rate of 3.5 lb a.i./A. No aerial apploication is

allowed.

2.3. Receptors

2.3.1

. Aquatic and Terrestrial Effects

Table 2.1 provides examples of taxonomic groups and the surrogate species tested to

eval uate the potential ecological effects of pesticides to these non-target taxonomic groups.

W ithin each of these very broad taxonomic groups, a measure of effect from either acute or chronic exposure is selected from the available test data. Toxicological data generated from

sur rogate test species, which are intended to be representative of broad taxonomic groups, are used to extrapolate potential effects on a variety of species (receptors) included under these taxonomic groupings.

Table 2.1. Example Taxonomic Groups and Surrogate Test Species Evaluated for Assessing Potential Ecological Effects of Fluensulfone.

Taxonomic Group Example(s) of Surrogate Species

Birds , terrestrial

- phase amphibians, and reptiles 1 

### Mallard duck ( Anas platyrhynchos ) Bobwhite quail ( Colinus virginianus ) Zebra finch ( Poephila guttata )

Mammals Wistar rat ( Ratus norvegicus )

Insects Honey bee ( Apis mellifera L. )

Freshwater fish , and aquatic

- phase amphibitans 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 Monocots

– corn ( Zea mays ) 3



### Dicots

– soybean ( Glycine max ) Aquatic plants and algae D uckweed ( Lemna gibba )

Freshwater algae (

Pseudokirchneriella subcapita )

1 Birds are surrogates for terrestrial

- phase amphibians and reptiles.

2 Freshwater fish are surrogates for aquatic

- phase amphibians.

3 Four species of two families of monocots; six species of at least four dicot families.-Page 10 of 117- 

### 2.3. 2. Ecosystems Potentially at Risk

The ecosystems at risk are often extensive in scope; therefore, it may not be possible to identify specific ecosystems at the screening level. In general terms, terrestrial ecosystems potentially at risk could include the treated site and areas immediately adjacent to the treated site that may receive drift or runoff. These areas could include the site itself, other cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats,

and ot her uncultivated areas.

Aquatic ecosystems potentially at risk include water bodies adjacent to, or down stream from, the treated area and might include impounded water bodies (lentic environments) such as ponds, l akes and reservoirs, or flowing waterways (lotic environments) such as streams or rivers.

For use s in coastal areas, aquatic habitat also includes marine ecosystems, including estuaries.

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, 1998a). The ecological entities include the following: birds

, amphibians, reptiles, mammals, freshwater fish and invertebrates, estuarine/marine fish and

inve rtebrates, terrestrial plants, insects, and aquatic vascular and non-vascular plants. The attributes for each of these entities may include growth, survival, and reproduction. (S ee Table

2. 2 in Section 2.6.2 , the Analysis Plan, for further discussion).

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 receptor. For an ecological pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, and a feasible route of exposure.

The conceptual model is intended to provide a written description and visual

re presentation of the predicted relationships between fluensulfone, potential routes of exposure, and the predicted effects for the assessment endpoints. The conceptual model consists of two major components: risk hypotheses and a conceptual diagram (USEPA, 1998a ).

2.5.1. Risk Hypotheses

For fluensulfone, the following ecological risk hypothesis is being employed for this

baseline-level risk assessment:

Based on the application methods, mode of action, and the sensitivity of non-target aquatic and terrestrial species, the proposed agricultural uses of fl uensulfone have the-Page 11 of 117-



### potential to reduce survival, reproduction, and/or growth in terrestrial and aquatic animals and plants via both direct and indirect adverse effects.

2.5.2

. Conceptual Diagram

Fluensulfone is applied pre-p lanting of seedlings/immature plants by broadcast or banded application or drip irrigation. The product is mechanically incorporated into the soil to deliver the applied chemical into the root zone (6-8 inches below the soil surface) for pest control. Ecological receptors that may potentially be exposed to fluensulfone include terrestrial and semiaquatic wildlife ( i.e. , mammals, birds, terrestrial-phase amphibians, terrestrial invertebrates, and reptiles) and plants. In addition, aquatic receptors, ( i.e. , freshwater and estuarine/marine fish and invertebrates, aquatic-phase amphibians, and plants) may also be exposed as a result of potential movement of fluensulfone to aquatic environments via spray drift, runoff, and/or base flow from ground water leachate originating at the site of application (no direct applications to water bodies are proposed). The potential exposure pathways and effects of the proposed new registration of

fluensul fone are depicted in Figure 2.1

.

Figure 2.1. Conceptual Model Depicting Sources of Exposure, Receptors, and Potential

Ad verse Effects from the Proposed U se s of Fluensulfone. 1-Page 12 of 117-



### 2.6. Analysis Plan

2.6.1

. Residues of Concern

The identified degradates of fluensulfone from environmental fate studies include

thi azole sulfonic acid (TSA), methyl sulfone (MS), butene sulfonic acid (BSA), deschlorofluensulfone, butene sulfinic acid, d eschloro thiazole sulfonic acid, and carbon dioxide (chemical names and structures are provided in Table 3.3 ). Available toxicity data for the major organic degradates indicate that in general degradates are orders of magnitude less toxic than

fluensul fone to fish, aquatic invertebrates and algae. However, MS, the most toxic of the tested

re sidues, had a somewhat similar toxicity profile compared to that of the parent compound for rats (1.3x more toxic) and fish (approximately half as toxic), but for invertebrates, available data on the relative toxicity was somewhat varied and much closer for terrestrial (earthworm – the

LC 50 

### was non-definitive but possibly very close and the NOAEC based on weight was very similar, 1.9x more toxic) than aquatic (mysid – MS was 19x less toxic), though the types of tests

used we re quite different and not directly comparable (see Tables 3.42 and 3.45 and Appendix F, Tables F.1 and F.2 ). It was much less toxic to vertebrates and green algae (two orders of magnitude less toxic to green algae ( Appendix F, Table F.3 ). Giv en its persistence, MS was deemed a residue of concern; therefore, a total toxic residues (TTR) approach was used in this assessment by incorporating exposure to both parent and MS (USEPA, 2011) for aquatic

orga nisms but parent alone for terrestrial organisms. MS should not impact plants above the ground s ince it is formed during the degradation reactions in soil and water.

2.6.2. Measures of Exposure

EFED used standard available models to evaluate potential exposures to aquatic and terrestrial organisms as described at http://www.epa.gov/pesticides/science/models_db.htm

. Specifically, in this assessment, aquatic EECs were calculated with the Tier II aquatic exposure model PRZM/EXAMS (PE). AgDRIFT was used for assessing off-target spray drift impacts.

The terres trial measures of exposure for animals from concentrations on various dietary items

were estimated with T-REX on a square foot basis, rather than a broadcast basis due to the appl ication methods. With either drip irrigation or immediate incorporation, the only aboveground exposure apart from spray drift that is expected is to organisms residing (or blown in) between furrows. Exposure of naturally-occurring terrestrial and semi-aquatic (wetland) plant species, estimated using TerrPlant (v1.2.2), was assumed to encompass areas outside the immediate use site, with exposed areas expected to be patchy, as mentioned above.

2.6.3. Measures of Effect

Mea sures of effect we re obtained from a suite of registrant-submitted OCSPP guidelinecom pliant studies that were conducted with a limited number of surrogate test species ( Table

2.1

, also see Section 3 and Appendices F and G

, )

. No additional ecotoxicity data on

fluensul fone were located, based on a July 17, 201 3 query of the open literature in the ECOTOX database (USEPA, 2 0 1 2 b ).-Page 13 of 117-



### The acute measures of effect used in this baseline-level assessment are the LD 50 

### , LC 50 

### (median Lethal Dose or Concentration , respectively) or EC 50 

### (median Effects Concentration). These are measures of acute toxicity that result in 50% of the respective effect on testedorganisms. The endpoints used with sublethal effect measures, mainly from chronic or subchronic exposure s, are the NOAEC and the NOAEL (No-Observed Adverse Effect

Concentr ation or Level, respectively). 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 were 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 fro m 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 fluensulfone to non-target organisms. The methods used to asses s the risk are consistent with current policies.

Table 2.2. Measures of Exposure and Effect Used in Assessing Potential Risks Associated with the Proposed Uses of Fluensulfone.
Assessment Endpoint 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 ( Freshwater fish and

invert ebrate s and

estuarine/ marine

invert ebrate s) 3 

### Survival Lowest tested LC 50 

### or EC 50 

### (acute toxicity test with TGAI ) 4 

### Peak EEC s 5



### Survival Lowest tested LC 50 

### or EC 50



### (acute toxicity test using formulation) 4 

### Spray drift EECs 6



### 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 5



### Aquatic plants (vascular and non

vascular) Survival and growth Lowest EC 25 

### (for non

- listed plants)

and corresponding NOAEC or EC 05 

### (for listed plants) Peak EEC s 5

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

- level risk assessments.

2 Birds are surrogates for terrestrial

- phase amphibians and reptiles.

3 Freshwater fish are surrogates for aquatic

- phase amphibians

. 4 TGAI toxicity endpoints were used for runoff risk calculations and formulation toxicity for spraydrift risk

calculations due to the unknown differential in long range transport of endproduct constituents; EFED at this time lacks the capability to estimate long range transport of adjuvents.

5 Aquatic EECs are based on the modeling described in Section 3.2.2. 1

. 6 Spray drift EECs are based on the modeling described in Section 3.2.2.1-Page 14 of 117-



### 2.6.4. Integration of Exposure and Effects

The exposure and t oxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on non-target species. For the risk assessment of fluensulfone, the RQ (R isk Quotient) method is used to compare estimated exposure and measured toxicity values. The RQ method involves dividing EEC s (Estimated Environmental Concentrations) by acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s LOCs (Levels of

Concern ; USEPA, 2004) ( Table 2.3 ). These criteria are used to indicate when applications of fluensulfone, as directed on the label, have the potential to cause adverse effects to listed and

non -listed non-target organisms.

Tab le 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/LC 50 1 0.5

Acute

Restricted Use Potential for effects to animals from acute exposures

Risks may be reduc ed through restricted use classification Peak EEC/LC 50 1 0.1

Acute Listed Species Listed species may be potentially affected by acute

exposures Peak EEC/LC 50 1 0.05

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/LC 50 1 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 2 /LC 50 (Dietary) 0.5 EEC/LD 50 (Dose)

Acute

Restricted Use Potential for effects to animals from acute exposures

Risks may be reduc ed through restricted use classification EEC 2 /LC 50 (Dietary) 0.2 EEC/LD 50 (Dose)

Acute Listed Species Listed species may be potentially affected by acute

exposures EEC 2 /LC 50 (Dietary) 0.1 EEC/LD 50 (Dose)

Chronic Potential for effects to non

- listed and listed animals from

chronic exposures EEC 2 /NOAEC 1

1 LC 50 or EC 50

. 2 Based on upper bound Ken e ga values for foliar exposure.-Page 15 of 117-



# 3

. Analysis

3.1. Use Characterization

Fluens ulfone 480 EC is an emulsifiable concentrate containing 4 pounds of fluensulfone per gallon. No aerial applications are allowed. Applications can be broadcast incorporated, banded and incorporated, or applied by drip irrigation. Apply at a rate of 56.0 to 112 fl. oz. per acre, a minimum of seven days before transplanting. Do not apply more than one application, and no more that 112 fl. oz. of product per acre, per year. For optimal performance, all applications must be incorporated by water and/or mechanical means to a depth of 6 – 8 inches. The use summaries are presented in Table 3.1

.

Table 3.1. Proposed Use Patterns for fluensulfone End-use Products.

Application Timing, Type, and Equip. Formulation

[EPA Reg. No.] Max. Single

Application

Rate Max. No.

Application per Season Max. Seasonal

Application Rate (lb ai/A) PHI

(days) Use Direction and

Limitation ‡

Cucurbit Vegetables include cucumbers, melons, (cantaloupes, watermelon, honeydew) squash; and Fruiting Vegetables include bell pepper, eggplant, groun dcherry, hot pepper, pepino, pepper (except black), pimento, sweet pepper, tomatilo, and tomatoes for p rocessing

Pre

- Plant; Drip irrigation,

Band applicator,

Broadcast

spray Fluensulfone

480 EC (40% ai) (4.0 lb ai/gal) [EPA Reg. No.

11678

- XXX] 1.75

- 3.5 lb

ai/A (56

- 112 oz/A) 1 appl. /year 3.5 lb ai/A (112 oz/A) N/A Apply with a minimum of seven days before transplanting.

No aerial applications

allowed.



### 3.2. Exposure Characterization

3.2. 1. Environmental Fate and Transport Characterization

Fluensulfone is not expected to volatilize from water or moist soil but may volatilize in dry field conditions. It is moderately mobile in soil (K FOC 

### range of 154-275 L/kg OC 

### ). Fluensulfone does not undergo hydrolysis. Aqueous photolysis is the fastest route of fluensulfone degradation (half- li v es of 0.58 and 0.68 days). The compound persists in anaerobic soil with a long half-life of 397 days, comparing with the half-life range of 8 to 15 days for

aer obic soil. For aquatic systems, the aerobic metabolism half-life ranged from 39 to 42 days, and the anaerobic metabolism half-life ranged from 23 to 26 days. Terrestrial field dissipation study results are relatively consistent with those of the laboratory studies, showing that the chemical’s dissipation half-lives range from 7.4 to 10.8 days (laboratory aerobic soil metabolism study half-lives ranged from 8 to 15 days). Fluensulfone has an octanol-water partition coefficient (K OW 

### ) of 91.2 (log Kow = 1.96), for this reason, the fish bioaccumulation study wa s not required. Table 3.2 summarizes the submitted chemical and environmental fate data for

fluensulfone.-Page 16 of 117-



### Table 3.2. Chemical Properties and Environmental Fate Parameters of Fluensulfone.

Parameter Value Source

Selected Physical/Chemical Parameters

Molecular mass (molecular formula) 291.7 g/mol (C 7 H 5 NO 2 S 2 ClF 3 ) (Calculated)

Vapor pressure 2.3 x 10 - 4 torr (25 °C) MRID 48574709

Aqueous solubility (20 C) 545.3 mg/L MRID 48574715

Henry’s Law Constant (20°C, pH 7) 1.65 x10 - 7 atm

- m 3 /mol MRID 48574710

Log octanol

- to

- water partition coefficient (log K OW ) (20°C) 1.96 (Kow 91.2) MRID 48574717

Dissociation constant (pKa) No pKa (neutral form from pH 4 to 9) MRID 48574719

Persistence

Hydrolysis half

- life (50 C) No substantial degradation (pH 4, 7, and 9) MRID 48574718

Aqueous photolysis half

- life (25 C) t1⁄2 = 0.68, 0.58 days (dark

- control

- adjusted) MRID 48574849

Soil photolysis half

- life; dark

- control adjusted

half

- life (25 C) t1⁄2 = 38.5 days (dark

- control

- adjusted) MRID 48574825

Aerobic soil metabolism half

- life (20°C) t1⁄2 = 8.05, 11.9 days (SFO * ) 15, 9.53 days (IORE * ) MRID 48574823

Anaerobic soil metabolism half

- life (20 C) t1⁄2 = 397 days (SFO * ) MRID 48574824

Anaerobic aquatic metabolism half

- life (20 C) t1⁄2 = 25.5 days (SFO * )

23.4 days (IORE * ) MRID 48574840

Aerobic aquatic metabolism half

- life (20 C) t1⁄2 = 39, 42 days (IORE * ) MRID 48574839

Mobility

Freundlich soil

- water partition coefficients (K d ); Freundlich organic carbon

- normalized partition coefficients (K OC ) K d = 4.06, 1.54, 0.69, 0.87, and 2.47 (mL/g) ;
K OC = 203, 154, 172, 157 and 275 (mL/goc) MRID 48574833

Field Dissipation

Terrestrial field dissipation half

- life; maximum leaching depth of parent DT 50 = 10.1, 8.7, 10.8, 7.4 days

. One trace detection in 30

- 45 cm. MRID 48574832

Fish Bioconcentration

Fish bioconcentration factors (steady

- state) Study waived due to low log K OW N/A

* SFO = Single First Order; IORE = Indeterminate Order Rate Equation



### 3.2.1.1. Transport and Mobility

Fluensulfone is not expected to significantly volatilize from soil or water bodies based on its water solubility (545.3 mg/L at 20°C), vapor pressure (2.3 x 10 -4 

### torr at 25°C), and Henry’s Law Constant (1.65 x 10 - 7 

### atm-m 3 

### /mol).-Page 17 of 117-



### According to the FAO mobility classification, fluensulfone is “moderately mobile” in soil

with a mean adsorption Koc of 187 mL/goc (range from 154 to 275) and a mean desorption Koc

of 706 mL/goc (range from 511 to 1058). Both thiazole sulfonic acid (TSA) and butene sulfonic acid (BSA) are classified as “highly mobile” with a mean Koc of 7.8 mL/goc, and 6.1 mL/goc, respectively for TSA and BSA (chemical names and structures of degradates are in

Table 3.3 ). MS is classified as “mobile” with a mean Koc of 47.1 mL/goc. There is little

concern of fluensulfone bioconcentration due to its low Kow value of 91.

Fluensulfone may be sorbed to residues in or dissolved in runoff feeding surface water bodies. The compound may also reach surface water bodies via spray drift and transport of dissolved residues in base flow from shallow ground water.

3.2.1.2. Degradation

Fluensulfone does not undergo hydrolysis in water bodies over the range of pH 4 to 9. It degraded rapidly in an aqueous photolysis study with the dark-control-adjusted half-lives in the

buff er and natural water of 0.68 and 0.58 days, respectively. In a soil photolysis study, fluensulfone degraded moderately with a dark-control-adjusted half-life of 38.5 days at 30-40 o 

### N.

Fluens ulfone was degraded to three metabolites in an aerobic soil metabolism study: TSA, MS, and BSA. The representative half-lives following the NAFTA degradation kinetics guidance ranged from 8 to 1 5 days. In the anaerobic soil metabolism study, the major degradates were

TSA and BSA. During the 100-day anaerobic incubation period, fluensulfone degraded slowly, with a 397-day half-life. Fluensulfone degraded in aquatic systems with DT 50 

### values of 23-26 days under anaerobic conditions and DT 50 

### values of 39-42 days under aerobic conditions. The

m ajor degradates under anaerobic conditions included MS, deschloro-fluensulfone, BSA, and

butene sulfinic acid.

3.2.1.3. Field Studies

The dissipation of fluensulfone in the field was best described by double first order in parallel (DFOP) kinetics at the California and Florida fields, single first-order (SFO) kinetics at

the Texas field, and indeterminate order rate equation (IORE) kinetics for the Ontario field. The calculated dissipation rates for fluensulfone across all sites were in close agreement, with an

estimated DT 50 

### of 10.1, 8.7, 10.8, and 7.4 days at the California, Florida, Texas, and Ontario test sites, respectively. The maximum fluensulfone residues occurred in 0 -15 cm soil depth at all four sites shortly after the applications (0 – 3 DAA(days after application)) at levels of 2.118, 0.965, 0.969, and 1.036 mg/kg soil at the California, Florida, Texas, and Ontario test sites, respectively. These residues were either at trace levels or below the LOQ (0.01 mg/kg soil) at the end of the study. The fluensulfone residues were retained in the top 15 cm soil, with trace levels of 0.025 and 0.014 mg/kg soil detected in a single sample at 30 – 45 cm soil depth at the California and Florida sites on 28 DAA and 1 DAA, respectively. Three transformation products were analyzed for and observed (TSA, BSA, MS)

. The DT 50 

### values for TSA were determined to be 66.7 and 99.9 days for the California and Texas test sites, respectively by the SFO model. The DT 50 

### values for TSA could not be accurately determined for the Florida and Ontario test sites due to the smaller number-Page 18 of 117-



### of samples during the decline phase. Likewise, the DT 50 

### values for BSA were not determined. The maximum TSA residues occurred in the 0 -15 cm soil depth at all four sites at levels of 0.254, 0.116, 0.174 and 0.20 mg/kg soil for the California, Florida, Texas, and Ontario test sites on 14, 28, 14, and 28 DAA, respectively. The TSA residues in surface soil were below the LOQ (0.01 mg/kg soil) at three sites by the end of the study and the fourth site, Ontario, had an average residue just slightly higher than the LOQ (0.011 mg/kg soil). Low levels of TSA residues (0.016 – 0.036 mg/kg soil) were detected at depths up to 75 – 90 cm later in the study. The maximum MS residues all occurred in 0 -15 cm soil depth at the four sites at levels of 0.044 – 0.135 mg/kg soil on 28 – 120 DAA. No MS residues were detected below 30 cm soil depth at any of the four sites. The maximum BSA residues all occurred in 0 -15 cm soil depth at the four sites at levels of 0.031 – 0.199 mg/kg soil on 7 – 28 DAA. BSA residues were retained in the top 15 cm soil depth at the Florida and Ontario sites and were detected at low levels at 75 – 90 cm and 45 – 60 cm soil depths at the California and Texas sites, respectively.

3.2.1. 4

. Environmental Degradates

The maximum formation fractions and the molecular structures of major identified transformation products are presented in Table 3.3 . The transformation products have the potential to reach either surface water or ground water as they were either a major degradate in the aerobic soil or aerobic aquatic metabolism studies (except one degradate, MS). Three major degr adates (TSA, MS, and BSA) were also analyzed for and observed in the terrestrial field dissipation study. Three degradates, deschloro-fluensulfone, butene sulfinic acid, and deschloro thiazole sulfonic acid were only detected in aquatic metabolism studies.

Table 3.3. Fluensulfone and Its Major Identified Environmental Transformation Products.

Common, Code,

and Chemical

Names Chemical

Structure Study Type MRID Maximum % Apply (day) Final % Apply

(Study End)

Parent

Fluensulfone (MCW

- 2);

5

- Chloro

- 2

- [3,4,4

- trifluor

- 3

- butene

- 1

- yl)sulfonyl]

- thiazole, CAS

Number

318290

- 98

- 1 Aerobic soil

metabolism 48574823 97.56% (0 day) 2.17%

(120 day) Aerobic aquatic

meatbolism 48574839 98.3% (0 day) 14.2%

(141 day)

Anaerobic soil

metabolism 48574824 97.0% (0 day) 53.1%

(100 day) Anaerobic aquatic

metabolism 48574840 99.6% (0 day) 17.4%

(103 day) Soil photolysis 48574825 96.3% (0 day) 34.4%

(14 day) Field dissipation 48574832 86% (0 day) @ or < LOQ

(363 day) Major Transformation Products (> 10%)

Thiazole sulfonic acid (TSA; M

3625);

5

- chloro

- thiazole

2

- sulfonic acid Aerobic soil

metabolism 48574823 77% (50 day) 74%

(120 day) Aerobic aquatic

metabolism 48574839 20.4% (141 day) 20.4%

(141 day)

Anaerobic soil

metabolism 48574824 28.8% (7 day) 27.3%

(100 day) Anaerobic aquatic

metabolism 48574840 5.6% (29 day) 3.7%

(103 day)-Page 19 of 117-

Common, Code,

and Chemical

Names Chemical

Structure Study Type MRID Maximum % Apply (day) Final % Apply

(Study End)

Soil photolysis 48574825 8.6% (14 day) 8.6%

(14 day) Field dissipation 48574832 47% (14 day) 0.011 ppm

(363 day) Methyl Sulfone (MS; M

- 3626);

5

- chloro

- 2

- methyl sulfonyl thiazole Aerobic soil

metabolism 48574823 7.45% (28 day) 0%

(120 day) Aerobic aquatic

metabolism 48574839 0.9% (141 day) 0.9%

(141 day)

Anaerobic soil

metabolism 48574824 5.1% (100 day) 5.1%

(100 day) Anaerobic aquatic

metabolism 48574840 28.7% (29 day) 18.6%

(103 day) Field dissipation 48574832 20% (28 day) < LOQ

(363 day)

Butene Sulfonic Acid (BSA M

3627) 3,4,4

- trifluoro

but

- 3

- ene

- 1

- sulfonic acid Aerobic soil

metabolism 48574823 31% (90 day) 24%

(120 day) Aerobic aquatic

metabolism 48574839 20.8% (103 day) 20.6%

(141 day)

Anaerobic soil

metabolism 48574824 16.5% (100 day) 16.5%

(100 day) Anaerobic aquatic

metabolism 48574840 13.1% (103 day) 13.1%

(103 day) Field dissipation 48574832 29% (14 day) < LOQ

(363 day)

Deschloro

fluensulfone

2

- (3,4,4

- trifluoro

3

- buteny sulfonyl) thiazole Aerobic aquatic

metabolism 48574839 22.2% (103 day) 21.5%

(141 day) Anaerobic aquatic

metabolism 48574840 20.2% (103 day) 20.2%

(103 day)

Butene Sulfinic

Acid Anaerobic aquatic

metabolism 48574840 20.3% (103 day) 20.3%

(103 day)

Deschloro

Thiazole Sulfonic

Acid Aerobic aquatic

metabolism 48574839 15.2% (141 day) 15.2%

(141 day)

Carbon Dioxide Aerobic aquatic

metabolism 48574839 22.8% (141 day) 22.8%

(141 day)

Anaerobic aquatic

metabolism 48574840 13.5% (61 day) 11.4%

(103 day)

Soil photolysis 48574825 19.9% (14 day) 19.9%

(14 day)

Aqueous photolysis 48574849 4.4% (96 hour) 4.4%

(96 hour)

Anaerobic soil

metabolism 48574824 13.3% (45 day) 12.4%

(100 day)

Aerobic soil

metabolism 48574823 55.7% (50 day) 11.2%

(120 day)-Page 20 of 117-



### According to the FAO mobility classification, both TSA and BSA are classified as “highly mobile” with a mean Koc of 7.8 mL/goc, and 6.1 mL/goc, respectively for TSA and

BS A. MS is classified as “mobile” with a mean Koc of 47.1 mL/goc. In aerobic soil conditions,

TSA has an average DT 50 

### of 421 days and MS has an average DT 50 

### of 33 days based on Single First Order (SFO) kinetics. The available environmental fate parameters of these degradates are presented in Table 3.4

.

Table 3.4. Environmental Fate Parameters of Fluensulfone Transformation Products.

Parameter Test Compound Value Source

Persistence

Aerobic soil metabolism half

- life (20°C) TSA 228, 448, 560 day MRID 48574828

MS 34.2, 41.3, 44 day MRID 48574829

Mobility

Freundlich organic carbon

normalized coefficients (K OC ) TSA 7.1, 9.7, 8.0, 8.4, 5.8 m L/g OC MRID 48574834

BSA 3.5, 5.0, 5.3, 10.5 m L/g OC MRID 48574836

MS 31.3, 37.4, 52.2, 55.4, 59.1 m L/g OC MRID 48574834



### 3.2.2. Measures of Aquatic Exposure

Exposure in surface water from the proposed fluensulfone uses due to runoff, erosion, and spr ay drift were assessed with the Tier II screening model, PE. To consider the potential effects of the transformation products, the aquatic exposure will address (1) fluensulfone alone, (2) MS alone, and (3) the combined residues of fluensulfone plus MS

. Exposure for off-target spray drift was assessed with AgDRIFT. Only parent fluensulfone was considered for AgDRIFT.

3.2.2.1. Surface Water Exposure

PE (PRZM/EXAMS)

(1) Fluensulfone Alone

The model input parameters for PE based on the general chemical and environmental fate

data for fluensulfone alone are listed in Tab le 3.4.-Page 21 of 117-



### Table 3.4. PE Chemical Input Parameters for Fluensulfone Alone.

Input Parameter Value Comment Source (MRID)

Molecular Mass (g/mol) 291.7 Product chemistry data (Calculated)

Henry’s Law Constant (atm

- m 3 /mol) 1. 6 5 x 10 - 7 Product chemistry data 48574710

Solubility in Water (mg/L) 545.3 Represents the value at 20 o C 49574715

Organic Carbon Partition

Coefficient (K OC ) ( m L/g OC ) 192 Represents the mean K OC of five values (154, 157, 172, 203, and 275) 48574833

Aerobic Soil Metabolism

Half

- life (days) 11.98 Represents the upper 90% confidence bound on

the mean of four half

- lives (8.05, 9.53, 11.9, and 15) 48574823

Aerobic Aquatic Metabolism

Half

- life (days) 45.93 Represents the upper 90% confidence bound on

the mean of two half

- lives (39 and 42.4) 48574839

Anaerobic Aquatic

Metabolism Half

- life (days) 27.68 Represents the upper 90% confidence bound on

the mean of two half

- lives (23.4 and 25.5) 48574840

Hydrolysis Half

- life (days) 0 Represents hydrolysis stable 48574718

Aqueous Photolysis

Half

- life (days) 0.784 Represents the upper 90% confidence bound on

the mean of two dark

- control

- adjusted half

- lives (0.58 and 0.68) 48574849



### The model input parameters used in PE to simulate fluensulfone application and crop management practices are provided in Table 3.5

. To reflect the timing with a minimum of 7 days before transplanting, the application dates were selected before the emergence dates which

were Oct . 1 for FL cucumber scenario and Oct. 16 for STX vegetable scenario.

Table 3.5. PRZM Scenario and Input Parameters Describing the Maximum Proposed

Fluensulfone Use Patterns.

Use Scenario App lication

Date App. Rate

(lbs a.i./A) App.

per Year Depth,

cm CAM Input IPSCND Input Application Efficiency/ Spray Drift

Fruiting vegetables STX vegetable Aug. 1 3.5 1 15 4 1 0.9 9 /0.0 1

Cucurbits FL cucumber Sept. 1 3.5 1 15 4 1 0.99/0.01



### Aquatic EECs from PE for fluensulfone alone are presented in Table 3.6 (also see Appendix A ).

Table 3.6. PE 1- in -10 -year Aquatic EECs of Fluensulfone Alone

Use Scenario Peak (μg/L) 21

- day Mean (μg/L) 60

- day Mean

(μg/L)
Fruiting vegetables STX vegetable 9. 60 7. 20 4. 72

Cucurbits FL cucumber 1 4. 50 13. 01 9. 16

Sediment Pore Water for parent
Fruiting vegetables STX vegetable 1. 49 1.4 6 1. 28

Cucurbits FL cucumber 2. 87 2.8 0 2.5 1-Page 22 of 117-



### (2) Methyl Sulfone Alone

The model input parameters for PE based on the general chemical and environmental fate data for methyl sulfone alone are listed in Table 3.7. De gra dation rate assumptions were made

in the absence of data.

Table 3.7. PE Chemical Input Parameters for Methyl Sulfone Alone.

Input Parameter Value Comment Source (MRID)

Molecular Mass (g/mol) 197.7 Product chemistry data (Calculated)

Henry’s Law Constant (atm

- m 3 /mol) 6.57 x 10 - 10 EPI Suite

Solubility in Water (mg/L) 29920 EPI Suite

Organic Carbon Partition Coefficient (K OC ) ( m L/g OC ) 47.08 Represents the mean K OC of five values (31.3, 37.4, 52.2, 55.4, and 59.1) 48574834

Aerobic Soil Metabolism

Half

- life (days) 41.91 Represents the upper 90% confidence bound on

the mean of three half

- lives (41.3, 34.2, and 44) 48574823

A na erobic Soil Metabolism

Half

- life (days) 0 Assume stable Assumption in the

absence of data

Aerobic Aquatic Metabolism

Half

- life (days) 83.82 Twice of the aerobic soil metabolism half

- life

value Assumption in the

absence of data

Anaerobic Aquatic

Metabolism Half

- life (days) 0 Assume stable Assumption in the

absence of data

Hydrolysis Half

- life (days) 0 Assume stable Assumption in the

absence of data

Aqueous Photolysis

Half

- life (days) 0 Assume stable Assumption in the

absence of data



### The model input parameters used in PE to simulate methyl sulfone alone application and crop management practices for the degradate methyl sulfone alone are provided in Table 3.8

. Inputs are the same as for the parent compound, with two exceptions about application rate and

no spr ay drift.

Table 3.8. PRZM Scenario and Input Parameters Describing Methyl Sulfone.

Use Scenario App lication

Date App. Rate (lbs a.i./A) App.

per Year CAM Input Depth,

cm IPSCND Input Application Efficiency/ Spray Drift

Fruiting vegetables STX vegetable Aug. 1 0.18* 1 4 15 1 1. 0/0

Cucurbits FL cucumber Sept. 1 0.18 1 4 15 1 1.0/0
* 0.18 = 3.5 (application rate of fluensulfone) /291.7 (molecular weight of fluensulfone) * 197.7 (molecular weight of methyl sulfone) * 7.45% (max detection of methyl sulfone in the aerobic soil metabolism study)



### Aquatic EECs from PE for methyl sulfone alone are presented in Tab le 3.9-Page 23 of 117-



### Table 3.9. PE 1- in

- 10 -year Aquatic EECs of Methyl Sulfone Alone

Use Scenario Peak (μg/L) 21

- day Mean (μg/L) 60

- day Mean

(μg/L)
Fruiting vegetables STX vegetable 0.73 0.65 0.55

Cucurbits FL cucumber 1.07 1.02 0.93

Sediment Pore Water for MS
Fruiting vegetables STX vegetable 0.47 0.47 0.46

Cucurbits FL cucumber 0.81 0.80 0.79



### (3) Fluensulfone + Methyl Sulfone

The model input parameters for PE based on the general chemical and environmental fate data for fluensulfone plus methyl sulfone are listed in Table 3.10. Since the parent compound is expected to exist in a greater amount than MS, the chemical properties of the parent compound

w ere used.

Table 3.10. PE Chemical Input Parameters for Fluensulfone Plus Methyl Sulfone.

Input Parameter Value Comment Source (MRID)

Molecular Mass (g/mol) 291.7 Product chemistry data

– parent (Calculated)

Henry’s Law Constant (atm

- m 3 /mol) 1. 6 5 x 10 - 7 Product chemistry data

– parent 48574710

Solubility in Water (mg/L) 545.3 Represents the value at 20 o C

– parent 49574715

Organic Carbon Partition Coefficient (K OC ) ( m L/g OC ) 47.08 Represents the mean K OC of methyl sulfone based

on five values (31.3, 37.4, 52.2, 55.4, and 59.1) 48574833

Aerobic Soil Metabolism

Half

- life (days) 24.01 

### R epresents the upper 90% confidence bound on

the mean of five half

- lives (6.73, 8.68, 12.8, 20.2, and 39 days) for fluensulfone + methyl sulfone 48574823

A na erobic Soil Metabolism

Half

- life (days) 1 3 53 Single value for fluensulfone + methyl sulfone 48574824

Aerobic Aquatic Metabolism

Half

- life (days) 60.38 Represents the upper 90% confidence bound on

the mean of two half

- lives (52.12 and 56.17 ) 48574839

Anaerobic Aquatic

Metabolism Half

- life (days) 59.61 Represents the upper 90% confidence bound on

the mean of two half

- lives (48.4 and 53.9) 48574840

Hydrolysis Half

- life (days) 0 Represents hydrolysis stable 48574718

Aqueous Photolysis

Half

- life (days) 0.784 Represents the upper 90% confidence bound on

the mean of two dark

- control

- adjusted half

- lives (0.58 and 0.68) for fluensulfone 48574849



### The model input parameters used in PE to simulate fluensulfone plus methyl sulfone appl ication and crop management practices for fluensulfone plus methyl sulfone are the same as for fluensulfone alone, as provided in Table 3.11

.-Page 24 of 117-



### Table 3.11. PRZM Scenario and Input Parameters Describing the Maximum Proposed

Fluensulfone Use Patterns Based on Fluensulfone Plus Methyl Sulfone.

Use Scenario App lication

Date App. Rate (lbs a.i./A) App.

per Year CAM Input Depth,

cm IPSCND Input Application

Effici ency/ Spray Drift

Fruiting vegetables STX vegetable Aug. 1 3.5 1 4 15 1 0.9 9 /0.0 1

Cucurbits FL cucumber Sept. 1 3.5 1 4 15 1 0.99/0.01



### Aquatic EECs from PE for fluensulfone plus methyl sulfone are presented in Table 3.12

. Total residue EECs are about 1.21 to 1.5 9 times greater than parent-only EECs.

Table 3.12. PE 1

- in -10 -year Aquatic EECs of Fluensulfone Plus Methyl Sulfone

Use Scenario Peak (μg/L) 21

- day Mean (μg/L) 60

- day Mean

(μg/L)
Fruiting vegetables STX vegetable 15.2 3 12.20 8.69

Cucurbits FL cucumber 17. 60 1 4.80 10. 74

Sediment Pore Water for parent + MS
Fruiting vegetables STX vegetable 3.38 3.32 3.12

Cucurbits FL cucumber 7. 73 7. 09 6. 0 1



### 3.2.2. 2

. Spray Drift Only Exposure

AgDRIFT Tier 1 ground model was used to estimate off-target spray drift amount to the

sta ndard EPA defined pond ( Tab le 3.13 , also see Appendix B ).

Tab le 3.13. Edge-of-Field Concentration Estimates from Spray Drift using High vs. Low Boom and Finest to Coarsest Droplet Size.

Exposure Edge of Field Concentration

High Boom: Finest Droplets Low Boom: Finest Droplets High Boom: Fine

Med/Coarse Droplets Low Boom:

Fine

- Med/Coarse Droplets

Aquatic 12

. 1 μ g/L

, 0.216 lb/A 5

. 26 μ g/L

, 0.0938 lb/A 3

. 24 μ g/L

, 0.0577 lb/A 2

. 14 μ g/L

, 0.0381 lb/A

Terrestrial 0.0414 mg/cm 2

, 3.69 lb/A 0.0400 mg/cm 2

, 3.57 lb/A 0.0397 mg/cm 2

, 3.45 lb/A 0.0395 mg/cm 2

, 3.53 lb/A



### Assuming operation at high boom, with the drop size distribution of ASAS very fine to

fine at 90 th 

### percentile data, with the maximum application rate of 3.5 lb a.i./ac and no buffer

consi deration, the resulting initial average concentration is 12.1 μ 

### g/L ( Appendix B ). Further analysis using larger droplet size and lower boom height showed that aquatic exposure could be reduced to 2.1 ug a.i./L. However, reductions were not seen for terrestrial exposure; even with the largest droplet size and lowest boom, spray drift still produced exposure above the application rate of 3.5 lb a.i./A (3.53-3.69 lb a.i./A from spray drift).-Page 25 of 117- 

### 3.2.2. 3

. Aquatic Bioaccumulation

Evaluation was not triggered for potential bioaccumulation of fluensulfone residues in a

freshwater

aquatic food web and subsequent risks these residues pose to terrestrial organisms via consumption of contaminated aquatic prey ( i.e. , aquatic invertebrates and fish). This was due to

fluensulfone’s low Kow of 91.

3.2.3. Measures of Terrestrial Exposure

The application methods for the proposed fluensulfone uses include broadcast and band

inc orporation and drip irrigation, and are considered in the terrestrial exposure assessment.

3.2.3.1

. Terrestrial Wildlife

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals, emphasizing a dietary exposure route for uptake of pesticide active ingredients. Pesticide residues on food items are estimated based on the assumption that organisms are exposed topesticide residues in a given exposure use pattern. Birds are used as surrogates for terrestrialphase amphibians and reptiles.

The T-REX model (v. 1.5, March 22, 201 2 ) wa s used to calculate dietary and dose-based EECs of fluensulfone residues on food items via spray applications for mammals and birds. Input values for deriving EECs in T-REX are located in Table 3.22

.

Table 3.22. T-REX Input Parameters for Deri ving Terrestrial EECs for Fluensulfone Proposed Uses - Maximum single application rate 1



### Proposed Use (Application Method) Application Rate (lbs a.i./A) Number of Applications (Interval between applications)*
Nematode Control Crop Groups 8 and 9:

- broadcast incorporated [6

- 8 inches]

- banded and incorporated [6

- 8 inches] 3.5 1 (NA) Nematode Control Crop Groups 8 and 9:

- applied by drip irrigation

1 Half-life used was the default 35 days.



### Upper-bound Kenaga nomogram values we re used to derive EECs for fluensulfone

exposur es to terrestrial mammals and birds. Table 3.23 summarizes the dietary- and dose-based EECs, based on the maximum single application rate of fluensulfone for the proposed use (also

see Appendix C ). A 1-year time period is simulated. Consideration is given to different typesof feeding strategies for mammals, including herbivores, insectivores and granivores. For dosebased exposures, three weight classes of birds (20, 100, and 1000 g) and three weight classes of mammals (15, 35, and 1000 g) are considered. All proposed application methods include either ground incorporation or drip irrigation. Since the residue studies show that neither fluensulfone nor MS are systemic (Health Effects Division email communication) and application is to bare-Page 26 of 117-



### ground followed by incorporation, exposure to mammals, birds, reptiles and terrestrial-phase amphibians would not be expected to occur through consumption of these constituents.

There fore, exposure to animals feeding on plants, fruits or pods is not expected, and, thus, the data not discussed in the text. Arthropods and seeds, however, may be present during application or enter the treated area and be subsequently consumed, e.g., seeds may be wind-blown into the

ar ea and then consumed. Due to application methods designed to ensure that the applied

fluensul fone reaches plant roots, exposure is also estimated using TREX calculations of mg a.i./sq. ft. and risk estimates based on LD 50 

### /sq. ft (see Section 4.1.2 ). See Appendix C for TREX output.

Tab le 3.23. T-REX Calculated EECs of Fluensulfone Proposed Application Methods at Maximum Application Rate of 3.5 lbs a.i./A.

Proposed Application

Methods Food Type Dietary

Based (ppm) (mammals and birds) Dose Based

(mg/kg

- bw) (birds) Dose Based (mg/kg

- bw) (mammals)

All Size

Classes Small

(20 g) Medium

(100 g) Large

(1000 g) Small

(15 g) Medium

(35 g) Large (1000 g)

Nematode Control Crop Groups 8 and 9:

- broadcast or banded and incorporated

or

- applied by drip irrigation Arthropods 329.00 374.70 213.67 95.66 313.68 216.79 50.26

Seeds 52.50 13.29 7.58 3.39 11.12 7.69 1.78

Smaller Scale Exposure Estimate

– using TREX Estimates by Square Foot from Broadcast Application.

mg per sq. ft. 5.47

-- -- -- -- -- -- LD 50 /sq ft

-- 0.35 0.05 <0.01 0.25 0.13 0.01



### 3.2.3. 2

. Sub -terrestrial Animals

Fluensulfone exposure to terrestrial wildlife wa s also evaluated by estimating pesticide residues on sub-terrestrial food items in the treatment area. Exposure to fluensulfone was assumed to be limited since application is either incorporated or drip-irrigated. Therefore

terrestrial EECs and acute risks were estimated based on loadings of pesticide per unit area (ft 2 

### ) and chronic exposure and risk estimated based on direct ingestion of contaminated soil invertebrates. In addition, acute risks to terrestrial invertebrates exposed to fluensulfone applications we re estimated using the concentration of fluensulfone in earthworms and earthworm toxicity data, which is used as a surrogate for soil dwelling invertebrates and their consumption by the terrestrial vertebrates. The earthworm fugacity evaluation estimated the soil concentration at 1-15cm depth immediately after treatment to be 2.2 mg/kg-soil ( Appendix D ).

3.2.3 .3

. Terrestrial Plants

Fluensulfone exposure estimates from TerrPlant for terrestrial plants inhabiting dry and

wetl and treated areas, we re derived from combined exposure estimates of runoff and spray drift ( Tab le 3.24 , also see Appendix E ).-Page 27 of 117-



### Table 3.24. EECs for Fluensulfone on Terrestrial Plants from Terrplant.

Description EEC , lb a.i./A

Runoff to dry areas 0.029

Runoff to semi

- aquatic areas 0.29

Spray drift 0.035

Total for dry areas 0.064

Total for semi

- aquatic areas 0.33



### The spray drift EEC was 0.35 lb a.i./A (total estimate for fluensulfone a.i.). The total EEC

est imates for dry and semi-aquatic areas were 0.06 and 0.33 lb a.i./A, respectively. As described earlier, with immediate incorporation and drip irrigation for all applications, the exposure is expected to be patchy, mostly impacting plants between furrows and those exposed to spray drift.

3. 3

. Ecological Effects Characterization

Ecological effects characterization is based on registrant-submitted toxicity data for fluensulfone (also referred to as fluensulfone TGAI, or parent); its formulated product,

Fluens ulfone 480EC; and metabolites of fluensulfone: TSA, MS, BSA, deschloro-fluensulfone,

bute ne sulfinic acid and deschloro thiazole sulfonic acid. Appendix F lists these studies, the ir review classifications, and associated deficiencies. In addition, the publicly-available version of

the ECOTOX database was searched on July 17, 2013 to check for more ecological effects data (USEPA, 2012 b). The results of this query show ed that no additional ecotoxicity data we re available for fluensulfone or its degradates; therefore, all toxicity endpoints we re taken from registrant-submitted studies.

A description of available aquatic and terrestrial toxicity data for fluensulfone, its formulated products, and degradates is provided in Section 3.3.1 and 3.3.2, respectively. Given that fluensulfone is a new active ingredient with no previous registration in the U.S. or any other

count ry, no query of the Agency’s Office of Pesticide Programs Ecological Incident Information Syste m (EIIS) 2 

### incident database, Aggregate Incidents database 3 

### or American Bird Conservancy 4



### database w as completed

, and it is assumed that no ecological incidents exist for fluensulfone.

3.3. 1

. Aquatic Toxicity Characterization

A summary of the most sensitive aquatic toxicity data for fluensulfone, including its formulated product, Fluensulfone 480EC, based on a current Agency review of all submitted data, is provided in Table 3.25 and discussed further in Sections 3.3. 2 .1 through 3.3. 2

. 4

. It should be noted that none of the several endpoints for aquatic test species exceed the limit of fluensulfone’s solubility in water (545 mg/L, MRID 48574715). EFED has confidence in the

toxi city values that are being used to estimate risk quotients because the submitted studies did not have significant data quality issues and were considered reliable for use in risk assessment.

2 http://www.epa.gov/oppefed1/general/databasesdescription.htm

. 3 EPA Aggragate Incident Reports (version 1.1).

4 American Bird Conservency database, http://www.abcbirds.org/

.-Page 28 of 117-



### Table 3.25. Summary of the Most Sensitive Acute and Chronic Toxicity Data for Aquatic

Or ganisms Exposed to Fluensulfone, based on mean-measured concentrations.
Aquatic Animals

Most Sensitive

Test Species Test

Substance 1 Acute Toxicity Chronic Toxicity

96

- hr

LC 50 /EC 50 /IC 50

m g a.i./L 48

- hr EC 50

mg a.i./L MRID NOAEC/

LOAEC mg a.i./L (Endpoints) MRID

Bluegill ( Lepomis

macrochirus ) TGAI

480EC 13

2.5 -- 48574853

48574929 -- --

Sheepshead

Minnow ( Cyprinodon
variegates ) TGAI

480EC 28

5.9 -- 48574852

48574928 -- --

Fathead

Minnow ( Pimephales promelas ) TGAI

-- -- -- 0.63/1.6 (based on
post

- hatch

survival and small, weak,

discolored fish) 48574854

Daphnid ( Daphnia

magna ) TGAI

480EC -- 22

0.38 48574855

48574930 (TGAI only)

0.20 / 0.39 (based on dry weight and reproduction ) 48574856

Mysid ( Americamysis

bahia ) TGAI 1.0

-- 48574864 0.37 / 0.75 (based on growth) 48574857

Eastern oyster ( Crassostrea virginica ) TGAI

480EC 7.8

0.077 -- 48574865

48574933 -- --



### Aquatic Plants

Most Sensitive Test Species Test

Substance Endpoint, mg a.i./L Effect (MRID)

Nonvascular: Freshwater Alga ( Pseudokirchneriella subcapitata ) TGAI

96.5 %

480EC EC 50 : 0. 0 22 mg a.i./L

EC 05 : 0. 0 11 mg a.i./L (based on cell density)

EC 50 : 0.0 15 mg a.i./L

EC 05 = 0.0040 mg a.i./L (based on cell density) 48574 858

48574931

Vascular:

Duckweed (Lemna gibba) TGAI

96.5 % EC 50 : 2.7mg a.i./L (based on biomass yield)

NOAEC: 0.49 mg a.i./L (based on frond number, frond yield, frond growth rate, biomass, biomass yield and biomass growth rate) 48574863

1 For risk to aquatic organisms, TGAI toxicity estimates were used for runoff calculations and TEP toxicity for spraydrift calculations ( Section 2.6.3 ).-Page 29 of 117- 

### 3.3. 1 .1. Toxicity to Freshwater Fish

Fluensulfone TGAI

As shown in Tab le 3.26

, three freshwater fish acute toxicity studies using the TGAI (95.7 -96.5%) were submitted to evaluate the toxicity of fluensulfone to fish in support of the new

chem ical registration.

Table 3.26. Freshwater Fish Acute Toxicity to Fluensulfone TGAI.
Test Species/

Test Substance (Flow

- through/Static) %

a.i. 96

- hour LC 50 

### , mg a.i./L

(95% C.I.) Slope Toxicity

Category MRID Study

Classification

Bluegill ( L

. macrochirus )

Fluensulfone TGAI ; (Static) 95.7 13 (12

- 15 ) Slope = NA [ Endpoints Affected: mortality surfacing, lethargy and lying on

bottom of vessel ] Slightly

Toxic 48574853 Acceptable

Rainbow trout ( Oncorhynchus mykiss )

Fluensulfone TGAI ; (Static) 96.5 38 (27

- 53 ) Slope = NA [Endpoints Affected: mortality, lying on bottom and loss of equilibruim ] Slightly

Toxic 48574740 Acceptable

C ommon Carp ( Cyprinus carpio )

Fluensulfone TGAI ; (Static) 95.7 41 (25

- 50 ) Slope = NA [Endpoints Affected: mortality, lethargy, surfacing, lying on bottom and loss of equilibruim ] Slightly

Toxic 48574851 Acceptable

Slope = NA - Probit slope calculations were not available; binomial method was used as there were less than two concentrations with partial mortality



### All three submitted acute toxicity studies with freshwater fish were classified as acceptable.

Observe d sublethal effects included lethargy, surfacing, lying on the bottom of the test chamber and loss of equilibrium. The reported 96-hr LC 50 

### ranged from 13 to 41 mg a .i./L (MRIDs 48574740, 48574851 and 48574853). F luensulfone TGAI is classified as s lightly t oxic to
freshwater fish on an acute basis.

A freshwater fish chronic early life stage toxicity test with fathead minnows was submitted

u sing fluensulfone TGAI (96.5 % a.i.) ( Table 3. 27 ).-Page 30 of 117-



### Table 3.27. Freshwater Fish Chronic Toxicity to Fluensulfone TGAI.

Test Species (Flow

through/Static; Duration) % a.i. NOAEC/LOAEC mg a.i./L, mean

measured Effect MRID Study

Classification

Fathead minnow ( P

. promelas ) (Flow

- through; 33 days) 96.5 % NOAEC = 0.63

LOAEC = 1.6 Based on Survival (Post

hatch Larval) and Small,

Weak and Discolored Fish

. Other Endpoints Affected: clinical signs of toxicity, total length, wet weight, and dry weight 48574854 Acceptable



### A 3

- day fish early life -stage study was conducted with the fathead minnow under flowthr ough conditions. Post-hatch larval survival was significantly reduced in the 1.6 mg a.i./L

tr eatment group compared with control fish (MRID 48574854)

. Therefore, the NOAEC and

LOAEC values were 0.63 and 1.6 mg a .i./L , respectively. Observed sublethal effects were also

observed at all treatment s above 1.6 mg ai/L , with increasing frequency of observation with increasing concentration level. Clinical sig ns of toxicity included small, weak, and/or discolored fish; fish surfacing; erratic swimming; and cranial swelling and hemorrhage.

Formulated Product

Two additional freshwater fish acute static toxicity studies were submitted using the

for mulat ed

product, Fluensulfone 480EC ( Table 3.28 ).

Table 3.28. Freshwater Fish Acute Toxicity to the MCW2 480EC Formulation.

Test Species (Flow

- through/Static) %

a.i. 1 

### 96

- hour LC 50 

### mg a.i./L, mean

- measured concentration [mg 480EC/L] (95% C.I., mg a.i./L) Slope Toxicity

Category MRID Study

Classification

Rainbow trout ( O

. mykiss ) (Static) 45.2 3.2 [7.0 mg 480EC/L] (2.7

- 3.7) Slope = NA [Endpoints Affected: mortality and loss of equilibrium ] Moderately

Toxic 48574927 Acceptable

Bluegill ( L

. macrochirus ) (Static) 45.2 2.5 [5.5 mg 480EC/L] (2.1

- 2.9) Slope = NA [Endpoints Affected: mortality, loss of equilibrium and lethargy ] Moderately

Toxic 48574929 Acceptable

Slope = NA - Probit slope calculations were not available; the LC 50 and 95% confidence interval were determined using Spearman-Karber analysis in CETIS (v. 1.8.6). Neither the probit nor moving average method could be used as there were less than two test concentrations at which the percent mortality was between 0 and 100%.

1 Fluensulfone active ingredient

.-Page 31 of 117-



### The 480EC formulation was 5 -12x more toxic than parent (also see Appendix G

, Table

G. 4 .) with reported 96-hr LC 50 

### values of 3.2 and 2.5 mg a .i./L , respectively for the rainbow trout and bluegill (MRIDs 48574927 and 48574929). Observed sublethal effects included lethargy

and loss of equilibrium. Based on the formulated product toxicity, fluensulfone is classified as moderately toxic to freshwater f ish on an acute basis.

Degradates

Three acute freshwater fish toxicity studies using the metabolites TSA, MS and BSA

were s ubmitted and are summarized in Ap pendix F . Toxicity to the bluegill ranged from slightly toxic to practically non-toxic (96-hr LC 50 

### values of 35 to >122 mg degradate /L , 52 to

>187 m g a.i./L expressed in terms of parent toxicity by adjusting for molecular weights). Based on the results of these tests, all tested fluensulfone metabolites were found to be less toxic than

the parent TG AI , with the possible exception of MS. Toxicity of MS (LC 50 

### = 35 mg MS/L, 52 mg a.i./L expressed as parent, MRID 48574874) was similar to parent (LC 50 

### = 11.6 mg a.i./L, MRID 48574853). Therefore, TTR includes both parent and MS exposure.

3.3. 1 .2. Toxicity to Freshwater Invertebrates

Fluensulfone TGAI

Freshwater invertebrate acute toxicity data for the waterflea ( Daphnia magna ) are available for fluensulfone TGAI and are presented in Tab le 3.29

.

Table 3.29. Freshwater Invertebrate Acute Toxicity to Fluensulfone TGAI.

Test Species (Flow

- through/Static) % a.i. 48

- hour EC 50 

### , mg a.i./L (95% C.I.) Slope Toxicity

Category MRID Study

Classification

Waterflea ( D

. magna ) (Static) 95.7 22 (17

- 29) Slope = NA [Endpoints Affected: Immobility, lethargy and surface entrapment ] Slightly

Toxic 48574855 Acceptable

Slope = NA - Probit slope calculations were not available; the EC 50 value was determined using Spearman-Karber (CETIS ver. 1.8.7.2). The probit method was not used due to a low goodness of fit probability (<0.001). Due to the bimodality of the mortality/immobility data, statistics were checked without data from the lowest test concentration. The results did not differ substantially (EC 50 of 21, rather than 22 mg a.i./L), so the lack of a clear dose:response relationship at the lower three test concentrations did not affect the results substantially. The endpoint used was based on Spearman-Karber results using all the data.



### The 48-hr EC 50 

### for Daphnia exposure to fluensulfone TGAI was 22 mg a .i./L (MRID 48574855) , classifying fluensulfone TGAI as slightly toxic to freshwater invertebrates on an acute exposure basis. Sublethal effects included lethargy, and surface entrapment

.

A 21 -day full life-cycle toxicity test was submitted for aquatic freshwater invertebrates using fluensulfone TGAI (MRID 48574856

, Table 3.30 ).-Page 32 of 117-



### Table 3.30. Freshwater Invertebrate Chronic Toxicity to Fluensulfone TGAI.
Test Species (Flow

through/Static

renewal; Duration) %

a.i. NOAEC/LOAEC mg a.i./L ( mean

measured concentration) Effect MRID Study Classification

Waterflea ( D

. magna ) (Flow

- through; 21 days) 96.7 NOAEC = 0.20

LOAEC = 0. 39 Based on Dry weight

and Reproduction

. Endpoints affected:

number of neonates/reproductive day, length of surviving adults, dry weight of surviving

adults 48574856 Supplemental/Quantitative



### In the daphnid life-cycle test (MRID 48574856), living offspring per reproductive day

and dr y weight were significantly reduced (p<0.05) in the 0.39 mg a.i./L treatment group compared with control fish. Therefore, the NOAEC and LOAEC values were 0.20 and 0.39 mg

a .i./L , respectively.

One additional 10-day spiked sediment toxicity study was submitted by the registrant to

ass ess the potential effects of fluensulfone on the sediment-dwelling freshwater invertebrate

m idge ( Chironomus tentans, Table 3.31 ).

Table 3.31. Toxicity of Sediment-Dwelling Freshwater Invertebrates to Fluensulfone

TGAI.
Test Species (Flow

- through/Static; Duration) %

a.i. Endpoint

(Mean Measured Concentration) Effect MRID Study

Classification

Chironomid

Chironomus tentans (Spiked sediment; Flow

through ; 10 days) 95.7 Sediment:

L C 50 : >51 mg ai/kg NOAEC = 27 mg a.i./kg LOAEC = 51 mg a.i./kg

Pore Water :
L C 50 : >157 mg ai/kg TOC 1

NOAEC = 66 mg a.i./L

LOAEC = 157 mg a.i./L

Overlying Water : NOAEC/ LOAEC

- values could

not be determined* Based on

Survival 2 48574862 Supplemental (non

- guideline study)/Quantitative

for survival data only

*Overlying water concentrations were <LOQ (<0.500 mg ai/L) for all levels.

1 Total Organic Carbon.

2 Though growth was measured (as Ash-free Dry Wt.) these data are not useable due to solvent effects on growth.-Page 33 of 117-



### The flow-through study was submitted based on guideline 850.1735 for sediment-water chironomid toxicity testing using spiked sediment, with formulated sediment similarly to that

desc ribed in OECD Guideline 218 (2004), except using alpha-cellulose instead of peat moss. The study was classified as “Supplemental” because of a solvent effect on the growth parameter, and so those results were not reportable (MRID 48574862). Mortality data, however, were

deem ed quantitative; these data showed that the LC 50 

### was >51 mg a.i./kg sediment, and >157 mg a.i./kg TOC (total organic carbon, endpoint from pore water analysis). The NOAEC based on mortality was 27 mg a.i./kg sediment and 66 mg a.i./L of pore water. Measured concentrations in the sediment ranged from 4.0 to 51.1 mg a.i./kg (ppm) and in the pore water from 9.2 to 157 mg a.i./L (ppm); all over-lying water samples measured <0.500 mg a.i./L.

Formulated Product

Toxici ty data for daphnia from the 480EC formulation ar e presented in Table 3. 3 2

.

Table 3.32. Freshwater Invertebrate Acute Toxicity to the MCW2 480EC Formulation.

Test Sp ecies (Flow

- through/Static) % a.i.

1 

### 48

- hour EC 50 

### mg a.i./L, mean

- measured concentration [mg 480EC/L] (95% C.I., mg a.i./L) Slope Toxicity

Category MRID Study

Classification

Waterflea ( D

. magna ) (Static) 41.99 0.38 [0.83 mg 480EC/L] (0.29

- 0.50) Slope = 3.19 [Endpoints Affected: immobility and

lethargy ] Highly Toxic 48574930 Acceptable

1 Fluensulfone active ingredient

.



### The available acute data for the D. magna show it to be much more sensitive to the 480EC formulation than TGAI, the EC 50 

### was 0.38 mg a.i./L (MRID 48574930) for the formulation, compared to 22 mg a.i./L (MRID 48574855) for TGAI. According to these data, the formulation is 58x more toxic than the fluensulfone a.i. alone to aquatic invertebrates

cl assifiying it as highly toxic.

Degradates

Three acute mysid toxicity studies using the metabolites TSA, MS and BSA were

submitted and are summarized in Appendix F

. These studies will be used to estimate the relative toxicity of freshwater invertebrates as well as estuarine/marine invertebrates and are discussed in the estuarine/marine invertebrate section ( 3.3.1.4 ).-Page 34 of 117- 

### 3.3. 1 .3. Toxicity to Estuarine/Marine Fish

Fluensulfone TGAI

One estuarine/marine fish acute toxicity study with the TGAI was required to evaluate the toxicity of fluensulfone to fish in support of the new registration. Results from the submitted study are found in Table 3.33 below.

Table 3.33. Estuarine/Marine Fish Acute Toxicity to Fluensulfone TGAI.

Test Species (Static/Static

- renewal) %

a.i. 96

- hour LC 50 

### mg a.i./L, mean

- measured

concentration (95% C.I.) Slope Toxicity

Category MRID Study

Classification

Sheepshead Minnow ( C

. variegatus ) (Static) 95.7 28 (20

- 38) Slope = NA [Endpoints Affected: mortality, surfacing and lethargy ] Slightly

Toxic 48574852 Acceptable

Slope = NA - Probit slope calculations were not available; binomial method was used as there were less than two concentrations with partial mortality



### A submitted acute toxicity study with sheepshead is classified as acceptable (MRID 48574852). The sheepshead was less sensitive than bluegill (96-hr LC 50 

### = 28 mg a.i./L compared to 13 mg a.i./L, respectively) but more sensitive than rainbow trout or carp (LC 50 

### = 38 and 41, trout and carp, Table 3.26 ). Observed sublethal effects included lethargy and surfacing.

Chronic toxicity data for estuarine/marine fish are not available. It wa s not feasible to
derive an acute- to -chronic ratio (ACR) for estuarine/marine fish based from freshwater data

sinc e acute data was not available for the fathead minnow, the only species with chronic data.

Formulated Product

One additional sheepshead acute static toxicity study was submitted using the formulated produc t, Fluensulfone 480EC ( Table 3.34 ).

Table 3.34. Estuarine/Marine Fish Acute Toxicity to the MCW2 480EC Formulation.

Test Species (Static/Static

renewal) % a.i. 1 96

- hour LC 50, mg a.i./L, mean

- measured concentration [mg 480EC/L] (95% C.I., mg a.i./L) Slope Toxicity Categor

y MRID Study

Classificati

on

Sheepshead

Minnow ( C

. variegatus ) (Static) 45.2 5.9 [13 mg 480EC/L] (5.0

- 6.8) Slope = NA [Endpoints Affected: mortality, lethargy and

surfacing ] Moderate ly Toxic 485749

28 Acceptable

Slope = NA - Probit slope calculations were not available; the LC 50 and 95% confidence interval were determined using Spearman-Karber analysis in CETIS (v. 1.8.6). Neither the probit nor moving average methods could be used since there was only one concentration at which the percent mortality was between 0 and 100.

1 Fluensulfone active ingredient

.-Page 35 of 117-



### The 480EC formulation was 5x more toxic than the technical active ingredient (also see Appendix G

, Table G.5 .) with an 96 -hr LC 50 

### of 5.9 mg a .i./L for the sheepshead minnow (MRID 48574928). Observed sublethal effects included lethargy and surfacing. Based on the formulated product toxicity, fluensulfone is classified as moderately toxic to saltwater fish on an

acute basis.

3.3. 1

. 4

. Toxicity to Estuarine/Marine Invertebrates

Fluensulfone TGAI

Estuarine/ marine invertebrate acute toxicity data for fluensulfone TGAI is summarized in

Table 3.35

.

Table 3.35. Estuarine/Marine Invertebrates Acute Toxicity to Fluensulfone TGAI.

Test Species (Flow

- through/Static) %

a.i. 96

- hour LC/ I C 50 

### mg a.i./L, mean

- measured

concentration (95% C.I.) Slope Toxicity

Category MRID Study

Classification

Mysid ( A

. bahia ) (Static) 95.7 LC 50 = 1.0 (0.46

- 1.9) Slope = NA [Endpoints Affected: mortality, lethargy and erratic swimming ] Highly Toxic 48574864 Suppmemental 1
Quantitative

Eastern oyster ( C

. virginica ) (Flow

- through) 96.5 IC 50 = 7.8 (6.3

- 9.7) [Endpoints Affected: shell growth ] Moderately

Toxic 48574865 Acceptable

Slope = NA - The probit method did not yield statistically sound results. The LC 50 and 95% confidence interval were calculated using the binomial test via Toxanal statistical software.

1 The negative control had 15% mortality. OCSPP 850.1035 guideline specifies that a static test is not acceptable if more than 10% of the control organisms die during the study. However, in this case the two lowest treatments had no mortality or sublethal effects, so the weight of evidence indicates that the organisms were reasonably healthy.



### The 96-hr LC 50 

### for mysid shrimp ( Americamysis bahia ) was 1.0 mg a .i./L (MRID

48574864 ). Observed sublethal effects included lethargy and erratic swimming. The 96

- hr EC 50 

### for the Eastern oyster ( Crassostrea virginica ), based on mean shell deposition

, was 7.8 m g a .i./L (MRID 48574865 ). Fluensulfone TGAI was found to be moderately to highly tox ic to estuarine/marine invertebrates on an acute exposure basis

.

One chronic toxicity study was submitted with estuarine/marine invertebrates ( Tab le

3. 36 ).

Table 3.36. Estuarine/Marine Invertebrates Chronic Toxicity to Fluensulfone TGAI.
Test Species (Flow

through/Static

renewal; Duration) %

a.i. NOAEC/LOAEC mg a.i./L ( mean

- measured concentration) Effect MRID Study

Classification

Saltwater Mysid (

A

. 95.92 NOAEC = 0.37 Based on Growth (Total 48574857 Acceptable-Page 36 of 117-

Test Species (Flow

through/Static

renewal; Duration) %

a.i. NOAEC/LOAEC mg a.i./L ( mean

- measured concentration) Effect MRID Study

Classification

bahia ) (Flow

- through; 38 days) LOAEC = 0.75 Length of Males)

. [Other Endpoints Affected: juvenile survival, adult survival, and total length of surviving males]



### In the mysid life-cycle test (MRID 48574857), total length of males was significantly

reduced (p<0.05) at 0.75 mg a.i./L co mpared with control fish. Other effects observed included reduced juvenile and adult survival. Therefore, the NOAEC and LOAEC values were 0.37 and

0.75 mg a .i./L , respectively.

Degradates

Three acute mysid toxicity studies using the metabolites TSA, MS and BSA were

submitted and are summarized in Appendix F, Table F.4

. Toxicity to the mysid ranged from slightly toxic to practically non-toxic (96-hr LC 50 

### values of 19 to >123 mg degradate /L , 28 to

>180 m g a.i./L expressed in terms of parent toxicity by incorporating molecular weights). Based on the results of these tests, all tested fluensulfone metabolites were found to be less toxic than

the parent TGAI, with the possible exception of MS. Though MS had similar toxicity to parent for fish ( see Section 3.3.1.1 ) it was 19x less toxic to mysids (LC 50 

### = 19 mg MS/L, 28 mg a.i./L expressed in terms of parent toxicity, MRID 48574877 than parent (LC 50 

### = 1.0 mg a.i./L, MRID 48574864, (see Appendix F, Table F.1 ). Th e mysid comparison was somewhat inconsistent with terrestrial invertebrate data, which showed similar toxicity between MS and parent, based on earthworm data ( see Section 3.3.2.3 ). Therefore, using conservative assumptions, the residues of concern for aquatic organisms included both fluensulfone parent and MS.

3.3. 1 .5. Toxicity to Aquatic Plants

Acute aquatic plant toxicity studies were submitted for non-vascular and vascular plants using the fluensulfone TGAI, the 480EC Formulation , and 480EC Formulation formulations.

T h e results of these studies are summarized in Table 3. 36

.

Fluensulfone TGAI

Sub mitted aquatic plant toxicity data with fluensulfone TGAI included studies with five

al gal species and one vascular plant. Data were submitted for freshwater green algae ( Pseudoki rchneriella subcapitata and Desmodesmus subspicatus, formerly, Scenedesmus subspicatus ), freshwater blue-green (cyanobacteria) algae ( Anabaena flos-aquae ), freshwater diatom ( Navicula pellicosa ), marine diatom ( Skeletonema costatum ) and duckweed (

Lemna gibba ) ( Table 3.37 ).-Page 37 of 117-



### Table 3.37. Acute Toxicity of Aquatic Plants to Fluensulfone TGAI and the MCW2 480EC

Formulation.
Test Species (Test Substance;

Flow

- through/Static; Duration) %

a.i. 1 Endpoint

mg a.i./L, mean

- measured

concentration (95% C.I.) Effect MRID Study

Classification

Non

- vascular Plants: Freshwater Green Algae

Freshwater Algae

P

. subcapita (TGAI; Static; 96 hr) 96.5 96

- hr EC 50 = 0.022 (0.020

- 0.024 )

NOAEC = <0.0036

EC 05 = 0.011 (0.0084

- 0.013) Based on Cell Density

. Other Endpoint Affected: growth rate. 48574858 Acceptable

Freshwater Algae

P

. subcapita (TGAI; Static; 96 hr) 94.4 96

- hr EC 50 = 0.025 (0.021

- 0.030 )

NOAEC = 0.0089

EC 05 = 0.011 (0.0068

- 0.17) Based on Cell Density

. Other Endpoint Affected: growth rate and yield. 48575017 Acceptable

Freshwater green algae

P

. subcapitata ( 480EC Formulation ; Static; 96hr) 39.37 96

- hr EC 50 = 0.015 (0.011

- 0.021 )

NOAEC = 0.0034

EC 05 = 0.0040 (0.0019

- 0.0083) Based on Cell

Density

. Other Endpoints Affected: growth rate and yield. 48574931 Acceptable

Non

- vascular Plants: Freshwater Blue

- Green Algae, Freshwater Diatom, and Marine Diatom Freshwater Alga ( Desmodesmus subspicatus, formerly,

Scenedesmus subspicatus ) (TGAI ; Static, 96 hr) 94.4 96

- hr EC 50 = 0.026 (0.014

- 0.050 )

NOAEC = < 0.0018

EC 05 = 0.0013 (0.0003

- 0.0057) Based on Cell

Density

. Other Endpoints Affected: growth rate and yield. 48575019 Acceptable

Freshwater blue

green algae Anabaena flos

- aquae (TGAI; Static, 96 hr) 96.7 96

- hr EC 50 = 6.9 (2.9

- 17 )

NOAEC = 2.8

EC 05 = 0.60 (0.067

- 5.5) Based on Yield

. Other Endpoints Affected: growth rate

and c ell density. 48574859 Acceptable

Freshwater diatom Navicula pelliculosa (TGAI; Static, 96 hr) 96.7 96

- hr EC 50 = 13 (9.9

- 17 )

NOAEC = 7.4

EC 05 = 4.7 (2.6

- 8.2) Based on Cell Density

. Other Endpoints Affected: growth rate and yield. 48574860 Acceptable

Marine diatom

Skeletonema costatum (TGAI; Static, 96 hr) 96.7 96

- hr EC 50 = 2.6 (2.2

- 3.0 )

NOAEC = 1.2

EC 05 = 1.1 (0.83

- 1.5) Based on Cell Density

. Other Endpoints Affected: growth rate and yield. 48574861 Acceptable

Vascular Plants: Duckweed

Duckweed

L

. gibba (TGAI; Static

Renewal; 7 days) 96.5 7

- d EC 50 = 2.7 (1.7

- 4.3 )

NOAEC = 0.49

EC 05 = 0.13 (0.03

- 0.54) Based on Biomass

Yield

. Other Endpoints

Affected: f

rond number, frond yield, frond growth rate, biomass, biomass growth rate 48574863 Acceptable

1 Fluensulfone active ingredient

.-Page 38 of 117-



### Non-Vascular Aquatic Plants Results of acute non-vascular plant data show the following sensitivity rank for

fluensul fone TGAI of the species tested: freshwater green algae > marine diatom > freshwater blue-green algae > freshwater diatom ( Tab le 3.37 ). Two submitted studies were available for the freshwater green algae ( P

. subcapitata ), the most sensitive species tested; the 96-hr EC 50 

### and NOAEC values were 0.022 and <0.0036 (EC 05 

### = 0.011) mg a.i./L and 0.025 and 0.0089 mg a.i./L, respectively, based on cell density (MRIDs 48574858 and 48575017). The freshwater green algae (

D. subspicatus ) had 96-hr EC 50 

### and NOAEC values of 0.026 and <0.0018 mg a.i./L based on cell density (MRID 48574931), very similar sensitivity to P

. subcapitata . The marine diatom ( S.costatum ) had 96 -hr EC 50 

### and NOAEC values of 2.6 and 1.2 mg a.i./L based on

decr eased cell density (MRID 48574861 ). For the freshwater blue-green algae ( A. flos-aquae ) and the freshwater diatom ( N. pellicosa ) the 96-hr EC 50 

### and NOAEC values were 6.9 and 2.8 mg a.i./L and 13 and 7.4 mg a.i./L, respectively, based on yield and cell density (MRIDs 48574859

and 48574861).

Vascular Aquatic Plants The 7-day EC 50 

### and NOAEC values for duckweed were 2.4 and 0.49 mg a.i./L, respectively, based on biomass yield (MRID 48574863, Tab le 3.37 ).

Formulated Product

Non-Vascular Aquatic Plants One study was submitted for non -vascular plant (green algae P. subcapitata ) toxicity using the 480EC formulation. The formulation had similar toxicity to parent (1.6x more toxic)

with 96-hr EC 50 

### and NOAEC values of 0.015 and 0.0034 mg a.i./L for the formulation (MRID 48574931) compared to 0.022-0.025 and <0.0036-0.0089 mg a.i./L for TGAI (MRIDs 48574858 and 48575017, Table 3.37 ).

Vascular Aquatic Plants No vascular plant toxicity studies were submitted for the formulation.

Degrad ates

Four acute non-vascular plant studies were submitted for four of the metabolites of fluensulfone (TSA, MS, BSA and Deschloro-Fluensulfone); these data are summarized in Ap pendix F ( Table F.3 ). Based on the results of these tests, all four metabolites tested were

found to be greater than two orders of magnitude less acutely toxic to green algae than the parent compound. The EC 50 

### ranged from 2.5 to >4.4 mg/L (3.7 to >6.8 mg a.i./L expressed in terms of parent) for transformation products compared to 0.022 mg a.i./L for the parent compound. Therefore, parent-only exposure was used to calculate risk to aquatic plants.-Page 39 of 117-



### 3.3.2 Terrestrial Effects Characterization

A summary of the most sensitive terrestrial animal toxicity data for fluensulfone TGAI and its formulated products is provided in Table 3.38 and discussed further in Sec tions 3.3.2.1 through 3.3.2.3 . The available Tier II terrestrial plant toxicity data for fluensulfone TGAI are provided in Section 3.3.2.4

.

Table 3.38. Summary of the Most Sensitive Acute and Chronic Toxicity Data for Terrestrial Organisms Exposed to Fluensulfone.

Species/

Chemical Acute Toxicity Chronic Toxicity

48

- hr LD 50 mg a.i./bee (95% C.I.) (Toxicity Classification) 14

- day LD 50

mg a.i./kg

- bw (95% C.I.) (Toxicity Classification) 8

- day LC 50

mg a.i./kg

- diet (95% C.I.) (Toxicity Classification) MRID NOAEC/LOAEC (95% C.I.) mg a.i./kg

- diet (Endpoints) MRID

Northern bobwhite quail ( Colinus
virginianus ) NA 1510 ( Slightly Toxic) 1 -- 48574842

-- --

Mallard d uck ( Anas platyrhynchos )/ (TGAI) NA

-- >5760 (NA) (Practically

Non

- toxic) 1 48574845 255//511 (Based on male weight gain inhibition) 48574846

Wistar rat ( Ratus norvegicus ) / (TGAI) NA 671 (Low to

Moderate Toxicity) -- 48574745 Offspring and Parental NOAEL = 250 ppm (♂ 16.2 and ♀ 23.0 mg/kg

- bw/day)

Parental LOAEL = 1880 ppm (Based on weight, food consumption and histopathology). 2 48574769

Honey Bee ( Apis mellifera )/ (TGAI) 0.167

(0.141

- 0.210) (Practically Nontoxic) NA NA 48574879 NA NA

Honey Bee ( A

. mellifera )/ (Formulation: MCW2 480 EC) >0.200 (NA)

(Practically Nontoxic) NA NA 48574934 NA NA-Page 40 of 117-

Species/

Chemical Acute Toxicity Chronic Toxicity

48

- hr LD 50 mg a.i./bee (95% C.I.) (Toxicity Classification) 14

- day LD 50

mg a.i./kg

- bw (95% C.I.) (Toxicity Classification) 8

- day LC 50

mg a.i./kg

- diet (95% C.I.) (Toxicity Classification) MRID NOAEC/LOAEC (95% C.I.) mg a.i./kg

- diet (Endpoints) MRID



### Terrestrial Plant Endpoints , lb a.i./A

Most Sensitive Test Species 

### NOAEC EC 25 Effect 

### Tier II Seedling Emergence

- using 480EC Formulation (MRID 48574945 )

Monocots:

Onion ( Allium cepa ) 1.21 2.50 Reduced Height

Dicots: Soybean ( Glycine max ) 0.141 >3.77 Reduced Emergence and

Survival 

### Tier II Vegetative Vigor

- using 480EC Formulation (MRID 48574972)

Monocots:
Wheat ( Triticum aestivum ) 0.0415 >3.49 Reduced Height

Dicots: Cabbage ( Brassica oleracea ) 0.419 1. 31 Reduced Dry Weight NA - Not Applicable; -- No Data

1 Passerine studies were inconclusive, but indicate that the toxicity is possibly greater. NOAEL for regurgitation in the canary was <155 mg a.i./kg-bw (MRID 48574843).

2 Based on reduced pup weights and spleen weights and an increase in post-natal pup loss between days 0 and 4 in the F1 and F2 offspring; also adult reduced body weight, body weight gain, food consumption and increased liver and kidney weights and histopathology changes in the liver and kidney.



### 3.3.2.1. Toxicity to Birds

Fluensulfone TGAI

Avia n acute oral toxicity studies using fluensulfone TGAI. were submitted for bobwhite quail ( Colinus virginianus ) and the canary ( Serinus carania ). Avain acute dietary toxicity studies using TGAI were submitted for bobwhite ( C. virginianus ) , mallard ( Anas platyrhynchos )

and zebra finch ( Poephila guttata )

. Results of th e s e test s are presented in Table s 3. 39 and 3. 40

below.

Table 3.39. Avian Acute Oral Toxicity to Fluensulfone Technical.

Test Species %

a.i. 1 

### LD 50



### mg/kg

- bw (95% C.I.) Slope Toxicity

Category MRID Study

Classification

Northern bobwhite quail ( C

. virginianus ) (TGAI) 96.5 1510 (1220

- 1880) Slope = 8.035 Slightly Toxic 48574842 Acceptable-Page 41 of 117- 

### Test Species %

a.i. 1 

### LD 50



### mg/kg

- bw (95% C.I.) Slope Toxicity

Category MRID Study

Classification

Canary ( Serinus carania ) (TGAI) 96.5 LD 50 : Not

determined 2

NOAEL: <155 mg ai/kg

- bw

based on regurgitation ND 48574843 Supplemental Quantitative (for upper

bound of NOAEL) Regurgitation Request ed

Passerine Dietary Study

N D – Not determined.

1 Fluensulfone active ingredient

. 2 Due to regurgitation at all treatment levels, an accurate LD 50 (lethal dose) could not be determined. An EC 50 for regurgitation was estimated to be 540 mg a.i./kg

- bw (310

- 1340 mg a.i./kg

- bw; slope 1.7) for use in risk description.



### The bobwhite oral LD 50 

### for TGAI was 1510 mg/kg-bw (body weight) (MRID 48574842), classifying fluensulfone as slightly toxic to upland avian species on an acute oral exposure basis.

No tre atment related mortality was observed in 292, 486, or 810 mg ai/kg- bw treatment groups. The NOAEL was >1506 mg ai/kg-bw for mortality. Clinical signs of toxicity were observed in the 810, 1350, and 2250 treatment groups, including lethargy, ruffled appearance, depression, loss of coordination, prostrate posture and lower limb weakness. Gross necropsy in the 2250 mg

ai /kg treatment group showed thinness with loss of muscle mass and a slightly mottled liver,

enl arged gall bladder, and slightly distended ceca. The LD 50 

### was 1510 mg ai/kg-bw with 95% confidence interval of 1220 to 1880 mg ai/kg. The NOAEL based on mortality was 810 mg ai/kg-bw. The NOAEL based on male and female body weight gain was 810 mg ai/kg-bw. The NOAEL based on clinical signs of toxicity was 486 mg ai/kg-bw.

Due to r egurgitation in the canary study at all treatment levels, (20% at 155 mg ai/kg, 30% at 259 mg ai/kg, 40% at 432 mg ai/kg, 50% at 720 mg ai/kg, and 80% at 1200 mg ai/kg) no

usea ble endpoints for calculating risk were determined apart from the regurgitation NOAEL of <155 mg ai/kg-bw (MRID 48574843). However, an estimated EC 50 

### for regurgitation of 540 mg a.i./kg-bw (310-1340 mg a.i./kg-bw; slope 1.7) is useable for risk description. No treatment related mortality was observed in the 155, 259, 432, or 720 mg ai/kg treatment groups. Clinical

si gns of toxicity were observed in the 259, 720, and 1200 treatment groups and included slight ruffled appearances. Clinical signs observed for the 1200 mg ai/kg treatment group also included reduced reaction to external stimuli and lethargy. Regurgitation within an hour of being dosed was observed at all treatment levels. A passerine dietary study was subsequently requested.

Avian sub-acute dietary toxicity tests were required for upland game and waterfowl bird species, as well as passerines. Results of the three submitted tests are listed in Tab le 3.40 below.-Page 42 of 117-



### Table 3.40. Avian Subacute Dietary Toxicity to Fluensulfone TGAI.

Test Species %

a.i. 8

- Day LC 50 

### mg a.i./kg

- diet, mean

measured

concentration (95% C.I.) Slope Toxicity

Category MRID Study

Classification

Northern bobwhite quail ( C

. virginianus ) 96.5 >5930 (NA) Slope = NA Practically

Nontoxic 48574844 Acceptable

Mallard duck ( A

. platyrhynchos ) 96.5 > 5 76 0 (NA) Slope = NA Practically

Nontoxic 48574845 Acceptable

Zebra Finch ( Poephila guttata ) 97.56 LD 50 : Not determined 2 ND 49138701 Supplemental/ Qualitative NA – Confidence intervals and p robit slope calculations were not available; no effects were observed.

2 Due to regurgitation in the earlier passerine study (MRID 48574843) with the canary, this study was modified for a one day exposure to avoid starvation of test subjects

.



### The LC 50 

### values for the bobwhite quail and mallard duck are greater than the highest mean-measured treatment level of 5930 mg a.i./kg-diet (MRIDs 48574844 and 48574844) ; the refore, fluensulfone TGAI is classified as practically non-toxic to avian species on a subacute dietary exposure basis. In the bobwhite study, 10% mortality occurred at the 3390 mg ai/kg treatment group. Clinical signs of toxicity for the 3390 and 5930 mg ai/kg treatment groups included ruffled appearance, lethargy, and wing droop, loss of coordination. Statistically significant reductions in mean body weight gain were measured in the 1870 mg ai/kg treatment

group and above, as compared to the control, from days 0-5. Based on mean-measured concentrations, the LC 50 

### was >5930 mg/kg diet and the NOAEC based on feed consumption and exposure-period weight gain was 1060 mg ai/kg. The NOAEC based on clinical signs of toxicity was 1870 mg ai/kg. The NOAEC based on mortality and post-exposure weight gain was 5930 mg/kg diet.

In the mallard study, no test substance mortality was observed in the control group or any of the treatment groups throughout the 8-day test period. The 8-day acute dietary LC50 was >5760 mg/kg diet. Clinical signs of toxicity for the 3220 and 5760 mg ai/kg treatment groups

inc luded lethargy and loss of coordination. Statically significant reductions (p<0.05) in mean body weight gain were observed for the 1030, 1840, 3220, and 5760 mg ai/kg treatment groups from Days 0-5. Reductions in feed consumption were observed for the 5760 mg ai/kg treatment groups from Days 0-5 and Days 6-8. The LC 50 

### was >5760 mg/kg diet and the NOAEC was 571 mg/kg diet, based on reductions in exposure period weight gain. Fluensulfone is classified as

pra ctically non-toxic to upland game and waterfowl bird species.

To assess toxicity to passerine bird species, an acute dietary toxicity study of fluensulfone

TGAI was conducted using adult zebra finches ( Taeniopy gia guttata ) in a modified study (MRID

49138701 ) designed to reduce complications caused by regurgitation and feed avoidance in the

ear lier canary oral dosing study (MRID 48574843). Due to the likelihood of avoidance of or-Page 43 of 117-



### aversion to the treated diet, the standard five-day dietary exposure was shortened to 24-h. However, this study did not fulfill current EFED recommendations for a five-day dietary study with the same species that regurgitated in the oral test, or a new oral study with a different species. 5 

### The results from this study could not be quantifiably extrapolated to a 5-day exposure endpoint and therefore, may be used only qualitatively to describe risk (for more information see

footnote to Table G.1

, Appendix G ).

Two avian reproduction tests using the TGAI were submitted to establish the chronic

toxi city of fluensulfone to birds. Results from these studies are summarized in Tab le 3.41

below.

Table 3.41. Avi an Chronic Toxicity (over 20 weeks) to Fluensulfone TGAI.

Test Species %

a.i. NOAEC/LOAEC mg a.i./kg

- diet,

mean

- measured

concentrations Effect MRID Study

Classification

Northern bobwhite quail ( C

. virginianus ) 96.5 NOAEC = 1010

LOAEC = >1010 No Effect at Highest

Concentration Tested 48574847 Supplemental (small cages)/ Quantitative

Mallard duck ( A

. platyrhynchos ) 96.5 NOAEC = 255

LOAEC = 511 Based on Growth (Male

Weight Gain Inhibition)

. Other Endpoint Affected: eggshell thickness. 48574846 Acceptable



### For the bobwhite quail study a single mortality was observed in the 519 mg ai/kg

tr eatment group; the mortality was not considered related to the treatment (MRID 48574847). No

over t signs of toxicity were observed in any of the treatments. There were no statistically significant differences in feed consumption or in adult body weight gain and hatchling bodyweight at any treatment level. There were no statistically significant differences in any of the reproductive parameters measured in the 519 or 1010 mg ai/kg treatment groups. At the 256 mg ai/kg treatment group, there were slight but statistically significant (p<0.05) increases in the number of viable embryos and hatchlings as percentages of eggs set, but these were not considered to be adverse treatment-related effects. No statistically significant differences upon egg shell thickness were observed at any treatment level (p>0.05). The NOAEL for parental toxicity and reproduction endpoints was 1010 mg ai/kg diet. This study was deemed sound but suppl emental due to a small cage size, adding an element of uncertainty in the reproductive behavior due to overcrowding. The results are quantitatively useable, however, since control

per formance was adequate and the uncertainty is not likely to affect the risk conclusions.

In t he mallard study there were no treatment-related mortalities overt signs of toxicity or treatment-related effects on adult body weight or feed consumption during the study (MRID 48574846). There was a significant reduction (p<0.05) in the proportion of eggs not cracked to eggs laid at the 511 and 991 mg a.i./kg treatment levels. Additional adverse effects on egg

5 Internal Memo from Donald J. Brady, Director of Environmental Fate and Effects Division, dated April 9, 2012, “Guidance for Use When Regurgitation is Observed in Avian Acute Toxicity Studies with Passerine Species.”-Page 44 of 117-



### quality were noted for eggs shell thickness, as a slight (i.e., 5%) significant (p=0.010) reduction at the 991 mg ai/kg treatment level, relative to the negative control. Male weight gain was significantly reduced (p=0.029) at the 511 mg ai/kg treatment level, but not significantly reduced (p=0.122) at the 991 mg ai/kg level; however, using a weight of evidence approach, it was reasoned that both levels at which birds exhibited weight loss over the course of the study were affected by fluensulfone. Overall food consumption during Week 1 of the test, as well as

re ductions in reproductive performance including a delay in the onset of egg production (most noticeable during the first six weeks of egg-laying) and decrease in embryo viability at the 991 mg ai/kg t reatment level were noted though not significantly different from the control group (p> 0.05). Based on adverse effects on adult male weight gain at the 511 and 991 mg ai/kg

tr eatment levels, the NOAEC in this study was determined to be 255 mg ai/kg; this is supported by reduced egg quality.

Formulated Product

An avian acute oral toxicity study was submitted using 480EC formulation (Table 3.42 )

.

Table 3.42. Avian Acute Oral Toxicity to the MCW2 480EC Formulation.

Test Species % a.i. 1 

### LD 50 

### mg/kg

- bw (95% C.I.) Slope Toxicity

Category MRID Study

Classification

Northern bobwhite quail ( C

. virginianus ) 41.99 998 (791

- 1260) Slope = 6.08 (3.10

- 9.07) [Endpoints Affected: mortality and weight gain] Slightly Toxic 48574951 Acceptable

1 Fluensulfone active ingredient.



### The LD 50 

### value for the bobwhite quail exposed to the 480EC formulation was 998 mg a.i./kg-bw (MRID 48574951). Clinical signs of toxicity in higher treatment groups included depression, reduced reaction to external stimuli, loss of coordination, prostrate posture, ruffled appearance, lower limb weakness, and lethargy. Weight gain was significantly reduced in males in the 810 mg ai/kg-bw dosage group. Toxicity was slightly enhanced (1.5x) by exposure to the

for mulation (LD 50 

### of 998 compared with 1510 mg a.i./L-diet, MRIDs 48574951 and 48574842, for parent and 480EC studies, respectively).

3.3.2.2. Toxicity to Mammals

Five mammalian acute oral toxicity studies using the TGAI, 480EC formulation and three

m etabolites (TSA, MS and BSA) were submitted to establish the toxicity of fluensulfone to

m ammals. Results of these tests are presented in Table 3.43 below.-Page 45 of 117-



### Table 3.43. Mammalian Acute Oral Toxicity to Fluensulfone TGAI and Metabolites (TSA, MS and BSA).

Test Species (Test Substance) % a.i. LD 50 

### mg/kg

- bw Slope Toxicity

Category 1 

### MRID Study

Classification

Wistar rat ( R

. norvegicus ) (TGAI) 96.5 671 mg a.i./kg

- bw Slope = NA Low to

Moderate Toxicity 2 48574745 Acceptable (fully reliable)

Wistar rat ( R

. norvegicus ) (Thiazole sulfonic acid) 93.6 >2000 mg tsa/kg

- bw Slope = NA Low Toxicity 3 48574783 Acceptable (fully reliable)

Wistar rat ( R

. norvegicus ) ( Methyl sulfone ) 98.1 500 mg ms/kg

- bw (300

- 2000) Slope = NA Low to

Moderate Toxicity 4 48574787 Acceptable (fully reliable)

Wistar rat ( R

. norvegicus ) (Butene sulfonic acid) 99.5 >2000 mg bsa/kg

- bw Slope = NA Low Toxicity 3 48574792 Acceptable (fully reliable)

Wistar rat ( R

. norvegicus ) ( MCW

- 2 480 EC

formulation ) 473.6 g/L 5 >2000 mg 480EC/kg

bw (>947 mg a.i./kg

bw) 5
Slope = NA Low Toxicity 3 48574924 Acceptable (fully reliable)

1 Based on guidance within the OECD 423 test guideline for acute oral toxicity testing, the guideline allows the classification of the test substance into a series of toxicity classes that are defined by a fixed cut-off LD 50 value.

2 According to the acute toxicity classification criteria for PMRA, MCW-2 tech. (fluensulfone) is of moderate toxicity via the oral route and based on the EPA classification criteria falls under Category III for acute oral toxicity. Under OCS criteria for acute toxicity endpoints, the test material is considered to be of low acute oral toxicity.

3 Based on PMRA’s acute toxicity classification system, thiazole sulfonic acid, butene sulfonic acid and the 480EC formulation are considered to be of low acute toxicity via the oral route. Based on the EPA classification criteria, they fall under Category II I for acute oral toxicity. Under OCS criteria for acute toxicity endpoints, they are considered to be of low acute oral toxicity.

4 Based on PMRA’s acute toxicity classification system, methyl sulfone is considered to be of moderate toxicity via the oral route. Based on the EPA classification criteria, methyl sulfone falls under Category II for acute oral toxicity. Under OCS criteria for acute toxicity endpoints, methyl sulfone is considered to be of low to moderate acute oral toxicity.

5 The test material was formulated at a concentration of 20% (weight:weight); dosing was 10 mL/kg-bw. Therefore, 473.6 g a.i./L *0.2 *10ml/kg-bw * L/1000ml *1000 mg/g = 947.2 mg/kg-bw.



### The acute mammalian oral LD 50 

### was 671 mg a.i./kg -bw based on TGAI toxicity to the wistar rat (MRID 48574745). One metabolite, MS, was slightly more toxic (1.3x) than parent

with an LD 50 

### of 500 mg TS. /kg-bw (MRID 48574787), but the other two (TSA and BSA) had lower toxicity (>2000 mg/kg-bw, MRIDs 48574783 and 48574792). The 480EC formulation

was al so less toxic than parent with an LD 50 

### of >947 mg a.i./kg-bw (MRID 48574924).

T herefore, fluensulfone and its metabolites are classified as having low to moderate toxicity to

m ammals on an acute oral exposure basis. A 2-generation wistar rat reproduction study using the TGAI was submitted to establish the toxicity of fluensulfone to mammals over prolonged periods. Results from this test are listed

in Tab le 3. 44 below.-Page 46 of 117-



### Table 3.44. Mammalian Chronic Toxicity of Fluensulfone TGAI *

Test Species % a.i. NOAEL/

LOAEL (mg a.i./kg

- diet; ppm ) Effect MRID Study

Classificati

on

Wistar rat ( R

. norvegicus ) 96.67

-

96.78 Parental NOAEL = 250 ppm (♂16.2 and ♀23.0 mg/kg

- bw/day) Parental LOAEL = 1880 ppm (♂122.0 and ♀169.1 mg/kg

- bw/day)

Reproductive NOAEL = 1800 ppm (♂122.0 and ♀169.1 mg/kg

- bw/day) Reproductive LOAEL = >1880 ppm

Offspring NOAEL = 250 ppm (♂16.2 and ♀23.0 mg/kg

- bw/day ) Offspring LOAEL = 1880 ppm (♂122.0 and ♀169.1 mg/kg

- bw/day) Reduced body weight, body weight gain, food consumption and increased liver and kidney weights and histopathology changes in the liver and kidney.

Increase in post

- natal pup loss between days 0

- 4 in both P and F1 generations.

Reduced pup weights and spleen weights and an increase in post

- natal pup loss

betwee n days 0 and 4 in the F1 and F2 offspring. 48574769 Acceptable (fully reliable)

Wistar rat ( R. norvegicus ) 96.1

-

97.0 Maternal and Developmental

NOAELs were 48.6 mg/kg bw/day;

LOAELs were 292 mg/kg bw/day Fluensulfone was not teratogenic in rats. Based on decreased body weight gain and food consumption in dams and on lower body weight of female pups 48574771 Acceptable (fully reliable)



### * Bolded values will be used in risk calculations.



### The NOAEL for wistar rat reproduction was 250 ppm (overall study intake of 16.2 mg/kg bw/day in mal es and 23.0 mg/kg bw/day in females; premating intake of 18.3 mg/kg bw/day in males and 20.3 mg/kg bw/day in females) b ased on decreased body weight, body weight gain, food consumption and increased liver and kidney weights and histopathology changes in the

li ver and kidney as well as decreased pup weights and spleen weights and an increase in postnatal pup loss between days 0 and 4 in the F 1 

### and F 2 

### offspring (MRID 48574769) at 1880 ppm, the LOAEL. At 1880 ppm, cumulative premating body weight gain was reduced by 21% and 12% for P males and females, respectively. Body weight gain was also lower for P (8%) and F1 (10%) females during gestation. I ncreased kidney and liver weights were seen in the 1800 ppm

tre atment group animals of both generations and adrenal weights were r educed in the P females.

Relative (to body weight) testes and epididymides weights were incre ased in the 1800 ppm F1

males. The reproductive N OAEL in male s and female s was 1800 ppm ( overall study intake of

122 .0 mg/kg bw/day in males and 169.1 mg/kg bw/day in females ; premating intake of 137 mg/kg bw/day in males and 149 mg/kg bw/day in females ) based on an increase in post

- natal pup loss between days 0

- 4 in both P and F1 generations. The reproductive L OAEL was not
determined as no treatment

- related effects on reproductive performance were observed

.-Page 47 of 117- 

### 3.3.2.3. Toxicity to Terrestrial Invertebrates and Beneficial Insects Honey b ees

Acute contact toxicity data bees wa s required, and 48-hr acute contact toxicity studies using fluensulfone TGAI, and the 480EC formulation were submitted to establish the toxicity of

fluensulfone to young adult honey bees ( Apis mellifera ) . In addition, non

- guideline honeybee

acute oral and bumblebee drip irrigation toxicity studies were submitted for the 480EC

f ormulation ( Table 3. 45 )

.

Table 3.45. Honeybee Acute Toxicity to Fluensulfone TGAI and to the MCW2 480EC

Formulation.

Test Species/

Test Substance Exposure

Route %

a.i. 1 

### Endpoint

(95% C.I.) Slope Toxicity

Category MRID Study

Classification

Honeybee ( A

. mellifera ) (TGAI) Acute

contact 96.5 48

- hr LD 50 = 167 μg a.i./bee

(141

- 210 μg a.i./bee) Slope = 4.73 (2.80

- 6.66) [Endpoints Affected: mortality and moving and coordination problems] Practically

Nontoxic 48574879 Supplemental 2
Quantitative

Honeybee ( A

. mellifera ) (MCW

- 2 480 EC Formulation) Acute

contact 41.99 48

- hr LD 50 = >200 μg a.i./bee 3

(NA) Slope = NA [Endpoints Affected: n o

m ortality or b ehavioral

a bnormalities] Practically

Nontoxic

48574934 Supplemental 2
Quantitative

Acute oral 41.99 48

- hr LD 50 = 83.7 μg a.i./bee

(42.0

- 97.8 μg a.i./bee) Slope = 4.69 (3.25

- 6.14) [Endpoints Affected: n o be havioral a

bnormalities] Practically

Nontoxic Supplemental Quantitative

Bumble Bee ( Bombus sp.) (MCW

- 2 480 EC Formulation) Drip

Irrigation 40.4 NO AE L: 3.5 lb a.i./A

(3930 g a.i./hectare).

LOAEL: > 3.5 lb a.i./A (>3930 g a.i./hectare)

. [Endpoints Affected: n o

o bserved e ffects. ] -- 4 48574910 Supplemental/ Quantitative

Non

- Guideline 2

Slope = NA – Confidence intervals and probit slope calculations were not available; no endpoints were affected.

1 Fluensulfone active ingredient.

2 Some uncertainty exists due to a lack of confirmation that the test organisms were randomly assigned to treatments, although described catching method may have produced some randomization.

3 Mortality was 23% in the 200 ug a.i./bee treatment; no behavioral abnormalities were observed.

4 No effects seen at maximum label allowance.



### The 48-hr LD 50 

### was 167 μg a.i./bee from fluensulfone TGAI exposure (MRID 48574879). Mortality was 16.7% and 63.3%, respectively, for 100 and 200 g/bee treatments. Behavioral abnormalities, including moving and coordination problems, were observed for bees

treated at 100 and 200 g/bee after 4 hours. For all surviving bees no behavioral differences were observed compared to control bees, at the 24 and 48 hour assessments.-Page 48 of 117-



### The 480EC formulation was less toxic than parent to the honeybee on an acute contact exposure basis ( MRID 48574934, also see Appendix G

, Table G .5. )

. From both TGAI and 480EC studies, fluensulfone is classified as practically non

- toxic to bees.

Information from non-guideline acute oral bee data shows a 48-hr LD 50 

### of 83.7 μg a.i./bee (MRID 48574934); the non-guideline bumble-bee drip-irrigation study shows a NOAEL

of 3.5 lb a.i./A based on no observed effects at the concentration tested (MRID 48574910).

Other Terrestrial Invertebrates and Beneficial Insects

As shown in Table 3.46 , additional terrestrial invertebrate toxicity studies were submitted for earthworms ( Eisenia fetida ), the parasitic wasp ( Aphidius rhopalosiphi ), the predatory mite ( Typhlodromus pyri ), the predatory minute pirate bug ( Ori us laevigatus ), and the green lacewing ( Chrysoperla carnea ).

Table 3.46. Toxicity to Other Terrestrial Invertebrates and Beneficial Insects using

Fluensulf

one TGAI and the MCW2 480EC Formulation.
Test Species /

Test Substance Purity 1 

### Endpoint Effect MRID Study

Classification

Studies with Technical Active Ingredient :

Earthworm Eisenia fetida (TGAI) 96.5% a.i. 14

- day LC 50 = 148 (133

- 163) mg a.i./kg soil dw Slope = NA NOAEC = 48.3 mg a.i./kg

soil dw Morta lity/ Weight (NOAEC based on weight) 48574880 Supplemental (non

- guideline study)

Studies with Degradates:

Earthworm

E

. fetida (Degradate

– Thiazole Sulfonic Acid) 99.6% TS

Acid 14

- day LC 50 >300 mg TS Acid /kg soil dw Slope = NA NOAEC = 300 mg TS Acid /kg soil dw (nominal) No Effects 48574881 Supplemental (non

- guideline study)

Earthworm

E

. fetida (Degradate

– Butene Sulfonic Acid) 99.5% BS

Acid 14

- day LC 50 >300 mg BS Acid /kg soil dw Slope = NA NOAEC = 75.0 mg BS Acid /kg soil dw (nominal) Mortality / Weight (NOAEC based on weight) 48574882 Supplemental (non

- guideline study)

Earthworm

E

. fetida (Degradate

– Methyl Sulfone) 98.7% MS 14

- day LC 50 >50 mg MS /kg

soil dw Slope = NA NOAEC = 25.0 mg MS /kg soil dw (nominal) Weight 2 48574883 Supplemental (non

- guideline study)

Studies with Formulation:

Earthworm

E

. fetida (MCW

- 2 480 EC) 492.7 g

a.i./L 14

- day LC 50 = 57.4 (53.1

- 62.2) mg a.i./kg soil dw Slope = NA NOAEC = 10.5 mg a.i./kg

soil dw Mortality/ Weight (NOAEC based on weight) 48574939 Supplemental (non

- guideline study)

Earthworm

E

. fetida 492.7 g

a.i./L 56

- d EC 50 = 23.0 (22.0

- 24.0) mg a.i./kg soil dw Mortality and Reproduction: 48574940 Supplemental (non

- guideline-Page 49 of 117-



### Test Species /

Test Substance Purity 1 

### Endpoint Effect MRID Study

Classification (MCW

- 2 480 EC) NOAEC = 10.5 mg a.i./kg

soil dw Weight and

Number of

Juveniles study)

Parasitoid wasp Aphidius rholaposiphi (MCW

- 2 480 EC) 492.7 g

a.i./L 48

- hr LR 50 = 0.0145 lb

a.i./A (nominal) (16.2 g a.i./ha, 33.7 [27.4

- 39.2] ml

480 EC/ha )

NOAEL = > 0.0086 lb a.i./A (nominal) ( > 9.6 g a.i./ha, > 20 ml 480 EC/ha) Survival/

No Effects in Reproduction 48574936 Supplemental (non

- guideline study)

Predatory mite, Hypoaspis aculeifer (MCW

- 2 480 EC) 492.7 g

a.i./L The 14

- day EC 50 = 86.5 (79.5

- 93.7) mg a.i./kg soil dw (205.9 mg 480 EC/kg soil dw)

NOEC = 55.4 mg a.i./kg soil dw (132 mg 480 EC/kg soil dw) Reproduction:

Number of

progeny 48574937 Supplemental (non

- guideline study)

Predaceous mite Typhlodromus
pyri (MCW

- 2 480 EC) 492.7 g

a.i./L 7

- day LR 50 = 0.892 lb a.i./A

(nominal) (1000 g a.i. /ha, 2080 (1780

- 2310) ml 480 EC/ha)

14

- day ER 50 : >0.892 lb a.i./A (nominal) (>1000 g a.i./ha, >2080 ml 480 EC/ha) Mortality/ Reproduction 48574935 Supplemental (non

- guideline study)

Springtail,

Folsomia

candida (MCW

- 2 480 EC) 492.7 g

a.i./L 28

- day EC 50 = 20.9 (16.2

-

28.2) mg a.i./kg soil dw (49.8 [38.5

- 67.2] mg 480 EC/kg soil dw) NOEC = 15.5 mg a.i./kg soil dw (37 mg 480 EC/kg soil dw) Reproduction:

Number of

progeny 48574941 Supplemental (non

- guideline study)

Ground

- active

beetle

Aleochara

bilineata (MCW

- 2 480 EC) 492.7 g

a.i./L ER 50 = 6.8 mg a.i./kg soil dw

(13.8 μl 480 EC/kg soil dw

12.7

- 15.2 μl /kg soil) NOAEC = 1.49 mg a.i./kg soil dw (3.02 μl 480 EC/kg soil dw) Reproduction /

Parasitisation

success 48574938 Supplemental (non

- guideline study)

NA = Not available; dw = dry weight; LR 50 = median lethal rate.

1 Fluensulfone active ingredient unless otherwise specified.

2 Three worms out of ten died in the 25 mg/kg treatment; however, none died in the 50 mg/kg treatment. Therefore,

this was not assumed to be treatment related.



### Earthworms

The results of the 14-day earthworm acute soil exposure toxicity tests with fluensulfone TGAI, and the 480EC formulation, show 480EC to be about twice as toxic as parent (LC 50 

### = 47.4 and 148 mg a.i./kg soil dw (dry weight) (MRIDs 48574939 and 48574880). The NOAEC

based on w eight and mortality was 10.5 and 48.3 mg a.i./kg soil dw (respectively) for 480EC and-Page 50 of 117-



### TGAI. An earthworm reproduction and growth toxicity study with 480EC resulted in a 56-d

EC 50 

### of 23.0 mg a.i./kg soil dw and an NOAEC of 10.5 mg a.i./kg soil dw based on mortality and reproduction (weight and number of juveniles, MRID 48574940).

Earthworm acute toxicity studies using the metabolites TSA, BSA and MS show TSA

and BSA to be less toxic than parent (MRIDs 48574881 and 48574882), but show MS to possibly have similar toxicity to parent a.i. (14-d LC 50 

### >50 mg MS/kg soil dw, compared to 57.4- 148 mg a.i./kg soil dw, MRIDs 48574883, 48574939 and 48574880, also see Ap pendix F)

. The NOAECs from these studies based on mortality and weight are 25.0 mg MS/kg soil dw compared to 10.5-48.3 mg a.i./kg soil dw).

Benefic ial Insects

Effects on two sensitive species, the parasitic wasp, and the predatory mite, were studied using the emulsifiable concentrate 48 0EC Formulation ( 40 % fluensulfone a.i.). The LR 50 

### values (lethal rate to 50% of the test population) were equivalent to an application rate of 0.0145 lbs a.i./A for the parasitic wasp (MRID 48574936) , and 0.892 lbs a. i./A for the predatory mite (MRID 48574935 ). For the wasp, the NOAEL was 0.0086 lb a.i./A based on survival and reproductive performance and for the predatory mite. For the predatory mite ( T. pyri ) , the 7

- day

ER 50 

### based on mortality and reproduction was >0.892 lb a.i./A.

In addition, extended laboratory studies were completed on the predatory mite ( H.

acule ifer ), the green lacewing and the ground-active beetle to examine the effects of fluensulfone

on mortality and reproduction (fecundity and fertility) with the emulsifiable concentrate 480EC

formulation ( 40 % fluensulfone). The 14

- day reproduction study with the predatory mite produced an EC 50 

### of 86.5 mg a.i./kg soil dw and an NOAEC of 55.4 mg a.i./kg soil dw based on number of progeny (MRID 48574937). A 28

- day reproduction EC 50 

### for the springtale was 20.9 mg a.i./kg soil dw and the NOAEC was 15.5 mg a.i./kg soil dw based on number of progeny (MRID 48574941). In the ground

- active beetle reproduction study, the ER 50 

### was 6.8 mg a.i./kg soil dw and the NOAEC was 1.49 mg a.i./kg soil dw based on parasitisation success (MRID 48574938).

3.3.2.4. Toxicity to Terrestrial Plants

Two Tier I terrestrial non-target plant studies were submitted for the 480EC formulation to assess the toxicity of fluensulfone to terrestrial plants. The results of the non-target terrestrial pla nt studies are summarized in Tables 3. 47 and 3.48

.-Page 51 of 117-



### Table 3.47. Summary of Tier I Toxicity of Fluensulfone WCW2 480EC Formulation ( 41.99% a.i.) to Non-target Terrestrial Plants.

Test Species Seedling Emergence (MRID 48574944 ) Vegetative vigor (MRID 48574943 ) 1

Test level

lb a.i./A Endpoint(s) Affected Test level

lb a.i./A Endpoint(s) Affected

Monocots

Corn ( Zea mays ) 3.44 None 2.78 Dry weight (7% reduction)

Onion ( Allium cepa )

3.44 Survival (22% reduction)* Emergence (11% reduction) Dry weight (19% reduction) & Height (18% reduction)* 2.78 Dry weight (17% reduction) & Height (13% reduction)*

Ryegrass (

Lolium

perenne )

3.44 Survival (63% reduction)* Emergence (36% reduction)* Dry weight (83% reduction)* & Height (70% reduction)* 2.78 Dry weight (24% reduction)

Wheat ( Triticum

aestivum ) 3.44 Dry weight (28% reduction) & Height (9% reduction)* 2.78 None

Dicots Cabbage ( Brassica

oleracea ) 3.44 Survival (8% reduction) Emergence (5% reduction) & Dry weight (16% reduction) 2.78 Dry weight (70% reduction)* & Height (10% reduction)*

Lettuce ( Lactuca

sativa ) 3.44 Dry weight (33% reduction) 2.78 None

Radish ( Raphanus

sativus ) 3.44 None 2.78 Dry weight (34% reduction)* Soybean ( Glycine

max ) 3.44 Dry weight (6% reduction) & Height (5% reduction) 2.78 Dry weight (50% reduction)* & Height (15% reduction)* Sugarbeet (

Beta vulgaris) 3.44 Survival (8% reduction) Emergence (14% reduction) Dry weight (14% reduction) & Height (5% reduction) 2.78 Dry weight (12% reduction)

Tomato ( Lycopersicon

esculentum ) 3.44 None 2.78 Dry weight (11% reduction)

* These species exhibited statistically significant reductions at the limit concentration relative to the negative control; therefore, Tier II toxicity studies will be required for these species and the respective studies. Bold Endpoints = >25% effect, triggering Tier II data need.

1 Signs of phytotoxicity included: chlorosis, leaf curl, necrosis, and stem curl

. 2 Signs of phytotoxicity included: necrosis, chlorosis, leaf curl, and unshed seed coat

.



### Based on the results of the submitted Tier I seedling emergence toxicity test (MRID 48574944) , application of 480EC Formulation at the nominal maximum label rate of 3.5 lbs

a.i ./A (3920 g a.i./ha), (measured rate of 3.44 lbs a.i./A, 3860 g a.i./ha), resulted in the following adverse effects: 63% reduction in survival, 36% reduction in emergence, 83% reduction in dry weight and 70% reduction in height of ryegrass ( L olium perenne ), 28% reduction in dry weight (also a non

- significant 9% reduction in height) of wheat ( Triticum aestivum ), and 33 % reductio n in dry weight of l ettuce (

Lactuca sativa ). Onions ( Allium cepa ), cabbage (

Brassica oleracea ),-Page 52 of 117-



### soybeans ( Glycine max) and subargeets ( Beta vulgaris ) also had observed effects in survival, emergence, weight and height, though not statistically significant (as compared to controls) nor greater than 25%

. For other observed phytotoxic effects, onion effects were categorized as slight to moderate and ryegrass was the most affected, with severe phytotoxic effects.

Based on the results of the submitted Tier I vegetative vigor toxicity test (MRID 48574943) , application of 480EC Formulation at the nominal maximum label rate of 3.5 lbs a.i./A (3920 g a.i./ha), (measured rate of 2.78 lbs a.i./A, 3120 g a.i./ha), resulted in adverse effects on dry weight of cabbage, radish ( Raphan us sativus ) and soybean, with reductions of 70%, 34% and 50%, respectively. Cabbage and soybeans also showed some reduction in height (10% and 15%, respectively). Corn ( Zea mays ), onion, ryegrass and sugarbeet also had reduced weight and/or height, though not statistically significant (as compared to controls) nor greater

than 25%

.

Since greater than 25% inhibitory effects were measured in both seedling emergence and vegetative vigor, Tier II studies were required. Results are summarized in Table 3.48

.

Table 3.48. Summary of Tier II Toxicity of Fluensulfone WCW2 480EC Formulation (41.99% a.i.) to Non-target Terrestrial Plants, lbs a.i./A (g a.i./ha).
Study Species Most sensitive parameter NOAEC EC 25 

### Seedling Emergence (MRID 48574945 )

Monocots

Corn ( Z. mays ) None 4.04 (4530) >4.04 (>4530)

Onion ( A. cepa ) Height 1.21 (1360) 2.50 (2800) Ryegrass (

L. perenne ) Height 1.21 (1360) 3.21 (3600)

Wheat ( T. aestivum ) None 4.04 (4530) >4.04 (>4530)



### Dicots Cabbage ( B. oleracea ) None 4.04 (4530) >4.04 (>4530)

Lettuce ( L. sativa ) None 3.77 (4230) >3.77 (>4230)

Radish ( R. sativus ) Survival 1.22 (1370) >3.77 (>4230) Soybean ( G. max ) Emergence & survival 0.141 (158) >3.77 (>4230) Sugarbeet (

B. vulgaris) None 3.77 (4230) >3.77 (>4230)

Tomato ( L. esculentum ) None 3.87 (4340) >3.87 (>4340) 

### Vegetative Vigor (MRID 48574972 )

Monocots

Corn ( Z. mays ) None 3.49 (3910) >3.49 (3910)

Onion ( A. cepa ) Height 1.11 (1250) >3.49 (3910) Ryegrass (

L. perenne ) None 3.49 (3910) >3.49 (3910)

Wheat ( T. aestivum ) Height 0.0415 (46.5) >3.49 (3910)



### Dicots
Cabbage (

B. oleracea ) Dry Weight 0.419 (470) 1.31 (1470)

Lettuce ( L. sativa ) Dry Weight 1.19 (1340) >3.66 (4100)

Radish ( R. sativus ) Dry Weight 0.396 (444) 3.02 (3390) Soybean ( G. max ) Dry Weight 0.419 (470) 1.15 (1290) Sugarbeet (

B. vulgaris) None 3.66 (4110) >3.66 (4100)

Tomato ( L. esculentum ) Dry Weight 1.11 (1250) >3.49 (3910) Bold Endpoints were the most sensitive and used for risk calculations.-Page 53 of 117-



### In the Tier II seedling emergence study (MRID 48574945), the most sensitive monocot

spec ies was onion, based on height, with NOAEC and EC 25 

### values of 1.21 and 2.50 lb a.i./A, respectively. Height was significantly affected in ryegrass, as well, along with emergence and survival. Dry weight was also significantly affected in the onion. The most sensitive dicot was soybea n, based on emergence and survival, with NOAEC and EC 25 

### values of 0.141 and >3.77 lb a.i./A, respectively. Survival was significantly affected in the radish. For radish, the %

inhi bition in seedling emergence compared to control ranged from -6 to 38%. An EC 25 

### of 5.92

lbs a.i./A was calculated

for radish; however this estimation was extrapolated beyond the range of concentrations tested and should be interpreted with caution..

Phytotoxic effects included necrosis, chlorosis, leaf curl, and stem curl. Instances of these effects were scattered and did not follow a dose response relationship. There were slight effects for corn, onion, tomato, sugarbeet, lettuce, soybean, and radish, though for lettuce there was a slightly higher level of phytotoxicity expressed in the control as compared to the treatment groups. Wheat and cabbage had ratings lower than those categorized as slight effects. Ryegrass experienced moderate phytotoxic effects.

In the Tier II vegetative vigor study the most sensitive monocot was wheat with an

NOAE C an d EC 25 

### of 0.0415 and >3.49 lb a.i./A, respectively (46.5 and >3910 g a.i./ha), based on height (MRID 48574972). The most sensitive dicot was cabbage with an NOAEC and EC 25 

### 0.419 and 1.31 lb a.i./A, respectively (470 and 1470 g a.i./ha) based on dry weight. Plant height

was si gnificantly affected in onion, wheat and soybean. Dry weight was significantly affected in onion, cabbage, lettuce, soybean, tomato and radish. There was no effect on survival for any species.

Signs of toxicity included adventitious growth, chlorosis, leaf curl, necrosis, plant death, stem curl and wilt. Based on the phytotoxicity rating used by the study author, ryegrass experienced little to no effects; corn, onion, wheat, tomato, sugarbeet, and lettuce experienced slight effects; and cabbage, soybean, and radish experienced moderate effects.

The study was classified as supplemental due to damage to control radishes and soybeans. In radishes, control damage included necrosis, wilt and plant death; therefore, some uncertainty is acknowledged. However, since plant sensitivities tend to run in plant families and since cabbage data is available (same plant family as the radish) an assumption can be made that

the radish would exhibit similar sensitivity and, therefore, this is not likely to impact the risk

ass essment conclusions. Necrotic effects were also seen in soybean controls, though less severe (but possibly more widespread). The soybean data are still useable, but the control necrosis adds to the uncertainty of the soybean results. Soybean wa s the most sensitive dicot (as well as overall) based on dry weight, though the results for the radish and cabbage (where only 1 plant of 30 suffered necrosis in the controls) are closely similar. Thus the impact of rejecting the soybean part of the test would seem to have limited impact on the final endpoint for vegetative vigor. The cabbage data, with almost identical endpoints were used, being deemed slightly more reliable; the impact on the risk picture from chosing cabbage or radish as the most sensitive dicot was insignificant. It is also noted that in the related Tier I Vegetative Vigor study (MRID-Page 54 of 117-



### 48574943), no necrosis was noted in the controls for either radish or soybean (also true for

cabba ge). It is also noted that again cabbage, radish and soybean were the most sensitive plants, the only species where reductions of >25% relative to the control were noted. There therefore seems to have been some unique problems with the radish and soybean controls in the Tier II study, but even if both results were rejected the final endpoint based on the cabbage results are very similar and unlikely to be a significant issue in the terrestrial plant risk assessment. Therefore, no new data are needed at this time.



# 4. Risk Characterization

4.1 Risk Estimation

Toxicity data and exposure estimates are used to evaluate the potential for adverse ecological effects on non-target species. As discussed previously, this baseline-level assessment

of fluensulfone relies on the deterministic RQ method to provide a metric of potential risks. The RQ provides a comparison of exposure estimates to toxicity endpoints ( i.e. , the estimated exposure concentrations are divided by acute and chronic toxicity values). The resulting RQs are compared to the Agency’s LOCs, as shown in Table 2.3

. LOCs are used by the Agency to indicate when the use of a pesticide, as directed by the label, has the potential to cause adverse effects to non-target organisms.

4.1.1. Aquatic Organisms

The highest baseline-level aquatic EECs were used to derive RQs. These exposure estimates were based on the proposed uses of fluensulfone to control nematodes on Crop Groups

8 (fruiting vegetables) and 9 (cucurbits) using PRZM/EXAMS ( Ap pendix A ). Peak EECs are used to represent acu te exposure to fish, aquatic invertebrates, and aquatic plants, and the highest

21 -day and 60-day average EECs represent chronic exposure to aquatic invertebrates and fish, respectively. In addition, to evaluate the acute risk to non-target aquatic organisms resulting

fro m exposure to the 480EC formulation via spray drift, EECs were calculated using AgDRIFT ( Table 3.13 and Appendix B ).

4.1.1.1. Aquatic Animals

Table 4.1 lists RQs calculated for aquatic animals exposed to fluensulfone, based on the highest PE -calculated EECs listed in Table 3.12

, for Crop Groups 8 and 9. These EECs are based on the TTR exposure from both fluensulfone and the degradate of concern, MS ( Ap pendix

A ).

The acute RQs based on the highest TTR EECs (parent + MS degradate) for the proposed

use pa tterns of fluensulfone for Crop Groups 8 and 9 were all <0.01. No fish or aquatic invertebrate taxon had an RQ above the Agency’s acute risk LOC (0.05) for listed species, based

on fluensul fone TGAI toxicity.-Page 55 of 117-



### Table 4.1. Aquatic Animal RQs (Risk Quotients) for Exposure to Fluensulfone TTR (TGAI plus MS ) Resulting from Runoff and Drift from Proposed Uses on Transplanted Crop Groups 8 and 9.

Taxa Surface Water EEC μg/L Endpoint

Used μg a.i./L (MRID) RQ values

Fruiting Veg. Cucurbits Based on Fruiting Vegetable (Group 8) Based on Cucurbit (Group 9)

Acute Exposure

Freshwater Fish Peak/ 15.2 Peak/ 17.6 LC 50 = 130 00 1 <0.01 <0.01

Estuarine/Marine Fish Peak/ 15.2 Peak/ 17.6 LC 50 = 280 00 2 <0.01 <0.01

Freshwater Invertebrates Peak/ 15.2 Peak/ 17.6 EC 50 = 220 0 3 <0.01 <0.01

Estuarine/Marine

Invertebrates Peak/ 15.2 Peak/ 17.6 EC 50 = 7800 4 <0.01 <0.01

Chronic Exposure

Freshwater Fish 60

- d/ 8.7 60

- d/ 10.7 NOAEC =

630 5 0.01 0.01

Estuarine/Marine Fish 60

- d/ 8.7 60

- d/ 10.7 0.01 0.01

Freshwater Invertebrates 21

- d/ 12.2 21

- d/ 14.8 NOAEC =

200 6 0.06 0.0 7

Estuarine/Marine

Invertebrates 21

- d/ 12.2 21

- d/ 14.8 NOAEC =

370 7 0. 03 0. 04

Sediment

- Dwelling Organisms Peak/ 3.4 Peak/ 7. 7 10

- d NOAEC

= 66000 8 <0.01 < 0.01

21

- d/ 3.3 21

- d/ 7. 1 <0.01 <0.01

Bolded and shaded values indicate RQs that exceed the Agency’s acute risk LOC (0.05 - listed species; or 0.5 - non-listed species) or chronic risk LOC (1.0). Asterisk (*) indicates that only the listed species LOC was exceeded.

1 Based on bluegill mortality (MRID 48574853).

2 Based on sheepshead mortality (MRID 48574852).

3 Based on daphnid mortality and lethargy (MRID 48574855).

4 Based on oyster shell-growth inhibition (MRID 48574865).

5 Based on fathead minnow NOAEC = 630 (48574854) – used for both freshwater and saltwater calculations.

6 Based on daphnid NOAEC = 200 (MRID 48574856).

7 Based on mysid NOAEC = 370 (MRID 48574857).

8 Based on chironomid 10-day survival NOAEC

, using pore water concentration (MRID 48574862).



### As shown in Tab le 4.1 , chronic RQ values for aquatic taxa (including sediment-dwelling organsims) were less than the Agency’s chronic LOC (1.0) based on TTR exposure.

Furt her characterization of the available fish and aquatic invertebrate acute and chronic toxicity data for the fluensulfone formulated products is also provided as part of the risk description in

Sect ion 4.2.1.1

.-Page 56 of 117-



### Table 4.2 lists the RQs that were calculated to characterize the risk potential relating to

non -target aquatic organisms exposed to the 480EC formulation via spray drift. RQs were based

on the spray drift EECs that were calculated using AgDRIFT ( Table 3.13 and Appendix B ).

Table 4.2. Aquati c Organism RQs for Exposure (via Spray Drift) to the MCW2 480EC

Formulation.

Taxa Study Type Spray

Drift

EEC 1


### μg/L Formulation

Endpoint Used μg a.i./L RQ values * 1 

### Buffer

Distance

Needed to

Remove Presumption of Risk, 2 

### ft

Freshwater Fish : Bluegill Acute

12.1 LC 50 = 2500 3 <0.01 0

Estuarine/Marine Fish : Sheepshead Acute LC 50 = 5900 4 <0.01 0

Freshwater Invertebrates: Daphnid Acute EC 50 = 380 5 0.03 0

Estuarine/Marine Invertebrates: Oyster Shell Deposition Acute EC 50 = 77 6 0

. 1 6 * 49

Non

- Vascular Aquatic Plants : Listed Species 7 NOAEC = 3.4 7 3.56 62

Bolded and shaded values indicate RQs that exceed the acute risk LOC (0.05 - listed animal species; 0.5 - nonlisted animal species; 1.0 for aquatic plants) or chronic risk LOC (1.0). Asterisk (*) indicates that only the listed species LOC was exceeded. N/A = Not Applicable.

1 Based on the highest calculated spray drift EEC value using AgDRIFT for application by high boom and very fine to fine droplet size - us ing the maximum proposed single agriculture application rate of 3.5 lbs a.i./A.

2 Removal of presumption of risk is defined by the endpoint times the acute LOC for listed species (0.05).

3 MRID 48574929.

4 MRID 48574928.

5 MRID 48574930.

6 Based on oyster shell-growth inhibition (MRID 48574933).

8 No non-vascular aquatic plant species are currently listed in the US.

7 Based on P. subcapitata cell density and yield (MRID 48574931 ).



### Due to the higher toxicity of the formulated product and the use of these data as the basis for calculating risk from spray drift, the risk calculations were greater than for runoff. The RQfor estuarine/marine invertebrates exceeds the listed species LOC (0.05). The RQ for nonvasc ular aquatic plants exceeds the LOC (1.0) based on the listed species RQ estimate. An

estimate buffer of 49 f

ee t is estimated for removal of the presumption of risk to estuarine/marine

inve rtebrates, but the risk is readily reduced by specifying either a low boom and 3 foot buffer or use of coarse droplet size (Appendix B).

4.1.1.2. Aquatic Plants

Table 4.3 summarizes RQ values and LOC exceedences for aquatic and terrestrial plants based on exposure to TTR (parent plus MS) and parent alone.-Page 57 of 117-



### Table 4.3. Aquatic Plant RQs for Exposure to Fluensulfo ne at maximum proposed application rate of 3.5 lb a.i./A for nematode control in Crop Groups 8 and 9.

Taxa Surface Water

EEC

μg a.i. /L Endpoint

Used μg a.i./L RQ values

Fruiting Veg. Cucurbits Based on Fruiting Vegetable (Group 8) Based on

Cucurbit (Group 9)

Aquatic vascular plants 1 Non

Listed Peak/ 9. 6 Peak/ 14 .5 EC 50 = 2700 <0.01 <0.01

Listed NOAEC = 490 0.020 0.03 0

Aquatic non

vascular plants 2 Non

Listed Peak/ 9. 6 Peak/ 14 .5 IC 50 = 22 0.4 36 0. 659

Listed IC 05 = 11 0.8 72 1.3 18

Bolded and shaded values indicate RQs that exceed the LOC (1.0) for listed and/or non-listed aquatic plants.

1 Based on L. gibba biomass yield (MRID 48574863).

2 Based on P. subcapitata cell density (MRID 48574858 ).



### RQ values for listed non-vascular plants based on fluensulfone exposure exceed the Agency’s listed species LOC for non-vascular plants from the proposed use on Crop Group 9 only ( Table 4.3 ). A 3 -foot buffer or specification of low boom or coarse droplet size readily reduces this risk ( Appendix B ).

4.1.2. Terrestrial Organisms

Table 4. 4 through 4. 6 summarize RQs and LOCs for av ia n (also surrogate for reptiles and terrestrial-phase amphibians) and mammalian exposure to fluensulfone based on residue on food as estimated using TREX and on spray-drift residue as estimated using AGDRIFT, as well as the distance from the application site to which risk no longer exceeds concern levels.

Tab le 4.4. Avian RQs for Acute Exposure to Fluensulfone at maximum proposed applicat ion rate of 3.5 lb a.i./A for nematode control in Crop Groups 8 and 9.

Avian Dose

- based Acute RQs

Type of Food 20 g bird 100 g bird 1000 g bird
Arthropods 2.84 1.27 0.40 *

Seeds 0.45 * 0.20 * 0.06

Grains 0.10 * 0.05 0.01

Mammalian Dose

- based RQs

Type of Food 15 g mammal 35 g mammal 1000 g mammal

Acute Chronic Acute Chronic Acute Chronic Arthropods 0.21 * 7.80 0.18 * 6.66 0.10 * 1 3.57

Seeds 0.03 1.24 0.03 1.06 0.02 0.57

Grains <0.01 0.28 <0.01 0.24 <0.01 0.13

Avian and Mammalian Dietary

- based RQs-Page 58 of 117-

Type of Food EECs (ppm) Kenaga Values Avian Mammalian

Acute RQs Chronic

RQs 3 Acute RQs 3 Chronic RQs

S eeds 5 3 <0.01 2 0.21 0.21

Arthropods 329 <0.06 2 1.29 1.32

Bolded and shaded values indicate RQs that exceed the Agency’s acute risk LOC (0. 1

- listed sp ecies; or 0.5

- non

listed species) or chronic risk LOC (1.0) . Asterisk (*) indicates that only the listed species LOC was exceeded.

1 Please note that an RQ matching the LOC is considered to exceed the LOC.

2 Definitive sub

- acute dietary toxicity data were unavailable due to low toxicity and so RQ calculations are presented

as less than ( < ) values

– these are not definitive RQs but constitute an upper bounding of the true RQs.



### Table 4.5. Terrestrial RQs for Exposure (via Spray Drift) to the MCW2 480EC

Formulation.

Taxa RQ and Spray Drift Fraction of Applied to

Remove Presumptin of Risk 1 

### Distance From Application

Site From Which LOCs are no Longer Exceeded

, 2 

### ft

Acute Chronic Acute Chronic RQ 3 

### Fraction RQ 3 

### Fraction

Both Birds and Mammals Consuming the Following Items:

Arthropods NA

– N/A 4,5 1.29

- 1.32 0.775

- 0.758 NA

– N/A 3.3

Bolded and shaded values indicate RQs that exceed the acute risk LOC (0.1 - listed species; or 0.5 - non-listed species).

As terisk (*) indicates that only the listed species LOC was exceeded. NA = Information Not Available; N/A = Not Applicable.

1 Target is LOC/RQ.

2 Defined as the endpoint times the acute LOC for listed species (0.05).

3 RQs from TREX were based on dietary toxicity data presented in Table 3.28 : mallard LC 50 (MRID 48574845 ), Mallard NOAEC (MRID 48574846) and rat NOAEL (MRID 48574769).

4 The bird acute dietary toxicity endpoint was non-definitive; however this was due to low toxicity; therefore acute dietary toxicity is potentially exceeded for birds eating short grass due to applied safety factors.

5 For Acute Dietary RQs, bird RQs were below the LOC with the exception of short grass consumers; dietary acute toxicity

information for mammals was not available.



### Table 4.6. Characterization of Minimum Foraging Area Needed to Allow for Ingestion of

Sufficient Mass of a.i. to Achieve LOC Exceedance

Mammalian Assessment 1

Foraging area (square feet) needed to achieve LOC exceedance assuming 100% feeding efficiency 2.28 Foraging area (square feet) needed to achieve LOC exceedance assuming 50% feeding efficiency 4.55 Foraging area (square feet) needed to achieve LOC exceedance assuming 10% feeding efficiency 22.75

1 

### Avian assessment was unavailable due to lack of chronic dose-based data.

4.1.2.1. Birds

As shown in Table 4.4

, acute LOCs based on dose-based toxicity estimates are exceeded for non-listed small and medium birds feeding on arthropods. Listed species LOCs are also exceeded for small granivores, small and medium seed eaters and large birds feeding on-Page 59 of 117-



### arthropods. Chronic LOCs are exceeded based on dietary toxicity for birds feeding on

ar thropods. The chronic LOC is also exceed for birds consuming arthropods (RQ of 1.3) from spray drift exposure for a distance of up to 3 -72 feet from an application site ( Tab le 4.5 ; also see Appendix B ). Specifying low boom and/or coarse droplets reduces the spatial extent of the LOC exceedances to 7-10 feet from an application site for medium and small birds feeding on

ar thropods.

An estimated EC 50 

### for regurgitation of 540 mg a.i./kg-bw (310-1340 mg a.i./kg-bw; slope 1.7) generated from the canary study (Table 3.39) was deemed useable for risk description. The EEC’s generated by TREX (Table 3.23) show that birds in the study area may be exposed to fluensulfone levels between 96 and 375 mg a.i./kg-bw on arthropod food items and between 3 and 13 mg a.i./kg-bw on seeds. According to this screening, the exposure levels are less than the

EC 50 

### for regurgitation, but some are above levels known to cause regurgitation (NOAEC of <155 mg a.i./kg- bw ). None of the EECs can be discounted as possibly producing regurgitation, since the NOAEC is not definitive. Therefore, arthropods and seeds in the study area may produce regurgitation which may lead to adverse effects. Since this exposure is expected to be patchy rather than widespread (assuming no aerial spray and immediate incorporation), this may not be a problem on a population scale; however, the extent of the effect is unknown.

4.1.2.2. Mammals

Similar to birds, acute LOCs based on dose-based toxicity estimates are exceeded for listed small, medium and large mammals feeding on arthropods. Chronic LOCs are exceeded based on both dose-based and dietary toxicity for mammals feeding on arthropods ( Table 4.4 ). The chronic LOC is also exceed for mammals consuming arthropods (RQ of 1.3) up to an

est imated 3.3 feet from the application site ( Table 4.5 ). A further breakdown of distances

ass ociated with LOC exceedances is found in Appendix B. TREX calculations show that only a

sm all foraging area is needed (2-23 sq. ft., depending on feeding efficiency) for a mammal to consume enough fluensulfone to exceed the LOC ( Table 4.6 ).

4.1.2. 3

. Terrestrial Invertebrates

Fluensulfone is classified as practically non-toxic to honey bees on an acute contact and oral exposure basis, based on available data for the TGAI and the 480EC formulation. Using the arthropod EEC of 329 mg ai/kg-diet (from TREX calculations above) and a bee weight estimate

of 0. 12 8g, a risk quotient can be estimated at 0.25 which exceeds the endangered species LOC (0.05) . Additional characterization of the potential effects of fluensulfone on terrestrial invertebrates, and beneficial insects, including consideration of non-guideline laboratory studies

with non-target arthropods, is provided as part of the risk description in Section 4.2.2.2

. Additionally, Appendix B presents a breakdown of distances from application sites associated with LOC exceedances for listed terrestrial invertebrates; risk extends up to 3 feet with low

boo m and coarse droplets to 16 feet with high boom and fine droplets.-Page 60 of 117- 

### 4.1.2. 4

. Terrestrial Plants

RQ values for listed semi-aquatic dicots exceed the Agency’s LOC of 1.0 based on fluensulfone exposure from the proposed use (RQ of 2.3). No other LOCs were exceeded for terrestrial plants ( Table 4.7 ).

Table 4.7. Terrestrial Plant RQs for Exposure to Fluensulfone at maximum proposed applicat ion rate of 3.5 lb a.i./A for nematode control in Crop Groups 8 and 9.

Taxa EEC a



### lb a.i. / A Endpoint Used

Seedling Emergence/ Vegetative Vigor

lb a.i./ A RQ values *

Dry Semi

Aquatic Spray

Drift Dry Semi

Aquatic Spray

Drift

Fluensulfone Alone



### Monocots Non

- Listed

0.064 0.327 0.035 EC 25 = 2.50 1 / >3.49 2 <0.1 0.13 <0.1

Listed NOAEC = 1.21 1 /0.0415 2 <0.1 0.27 <0.1



### Dicots Non

- Listed EC 25 = > 3. 77 3 / 1. 31 4 <0.1 <0.1 <0.1

Listed NOAEC = 0.141 3 /0.419 4 0.46 2.32 <0.1

* RQs that exceed the LOC (1.0) for listed or non-listed terrestrial plants are bolded and shaded.

1 Based on onion height (MRID 48574 945 ).

2 Based on wheat height (MRID 485749 72 ).

3 Based on soybean emergence and survival (MRID 485749 45 ).

4 Based on cabbage dry weight (MRID 48574972 ).



### 4.2. Risk Description

Fluensulfone is characterized as in termediate volatilie under field conditions and

moderat ely mobile in soil. Fluensulfone does not undergo hydrolysis. Aqueous photolysis is the

fastes t route of fluensulfone degradation (half-life of 0.58 and 0.68 days). It is quite mobile and

per sists in anaerobic soil. For aerobic aquatic systems, the half-life is slightly longer (39 to 42 days) than in anaerobic systems (23 to 26 days). Terrestrial field dissipation half-lives are less than aquatic (7.4 to 10.8 days) and fluensulfone is not expected to bioaccumulate.

Based on the effects assessment, fluensulfone is classified as moderately toxic to fish (a lso surrogate for aquatic-phase amphibians) and highly toxic to aquatic invertebrates, on an acute basis, based on toxicity of the 480EC formulation. Fluensulfone TGAI alone is only slightly toxic to fish and freshwater invertebrates, though highly toxic to mysids and moderately toxic to oysters. Chronic exposure of aquatic organisms to fluensulfone resulted in reduced

sur vival and growth (weight and length) and an observed sign of toxicity, such as small, weak and discolored fish. Fluensulfone is practically non-toxic to birds based on dietary data, and ranges from slightly to moderately toxic to birds based on oral dosing data. Fluensulfone has

low to m oderate toxicity to rats. Fluensulfone is practically non-toxic to bees (the 480EC

for mulation being less toxic than TGAI to this taxon).

The results of this baseline-level risk assessment indicate that the proposed use of fluensulfone for nematode control on Crop Groups 8 and 9 has the potential for direct adverse-Page 61 of 117-



### acute effects on listed birds, mammals, terrestrial invertebrates, aquatic invertebrates (except sediment-dwellers) and aquatic and semi-aquatic plants. All proposed uses of fluensulfone result in potential direct adverse chronic effects on listed and non-listed mammals. Based on the results of the baseline-level assessment, the risk hypothesis [ ...the proposed fluensulfone uses have the potential to reduce survival, reproduction, and/or growth in terrestrial and aquatic organisms ] is supported. These results are based on all application rates for the proposed

fluensulfone use on both crop groups. Although direct adverse effects to fish and sedimentdwelling organisms from fluensulfone use are not expected, indirect effects to these taxa are possible, given the effects on aquatic invertebrates and non-vascular aquatic plants, which could

indi rectly impact the aquatic organisms that feed on these species.

4.2. 1

. Risks to Aquatic Organisms

4.2.1. 1. Risks to Aquatic Animals

Acute RQs for fish and freshwater invertebrates did not exceed the Agency’s listed species LOC (0.05) for the proposed use to control nematodes on Crop Groups 8 and 9. Additionally ( Table 5.2) , the probability for acute direct effects ( i.e. , mortality) to individual

listed fish at the highest derived RQ value is likely very low , ~>1 in 8.86E+18. The probability for acute direct effects to individual listed freshwater invertebrates at the highest derived RQ

value is 1 in 1.69E+06. Marine invertebrates were the only taxa that had an RQ above the Agency’s acute risk to listed species LOC of 0.05 (RQ = 0.16 from spray drift). The probability

for acut e direct effects to individual listed estuarine/marine invertebrates ranges was low (~1 in 4.18E+08) for mysids exposed at the listed species LOC.

For chr onic risk, the Agency’s chronic LOC (1.0) was not exceeded for freshwater invertebrates based on TTR exposure

4.2.1. 2. Risks to Aquatic Plants

List ed non-vascular aquatic plants were determined to be at risk if exposure occurs. However, no non-vascular aquatic plant species are currently listed in the US.

4.2.2. Risks to Terrestrial Organisms

4.2.2.1. Birds, Terrestrial-Phase Amphibians and Reptiles

Acute LOCs based on dose-based toxicity estimates were exceeded for non-listed small and medium birds feeding on arthropods. Listed species LOCs were also exceeded for small granivores, and large birds feeding on arthropods. Chronic LOCs are exceeded based on dietary toxicity for birds feeding on arthropods. The chronic LOC is also exceed for birds consuming arthropods (RQ of 1.3) from spray drift exposure; an estimated 3.3 feet is needed to remove the-Page 62 of 117-



### presumption of risk. T 

### he probability for acute direct effects to individual listed birds (also reptiles and terrestrial-phase amphibians) at the highest derived RQ value range from 1 in 1 to 1


### in 1.05E+17

.

As previ ously discussed in Section 3.3.2.1 , avian acute oral data are now required for passerine species, as well as either waterfowl or upland game species. Two passerine studies

were s ubmitted, one with the canary and one with the zebra finch. Due to regurgitation in the canary study at all treatment levels, no useable endpoints were determined apart from a nondefinitive regurgitation NOAEL. A single mortality was observed, but not thought to be treatment related. A passerine dietary study was subsequently requested. In response, a zebra

finch diet ary study was submitted. This study was designed to reduce complications caused by regurgitation and feed avoidance in the earlier canary oral dosing study. Due to the likelihood of avoidance of or aversion to the treated diet, the standard five-day dietary exposure was shortened

to 24-h . Study authors cited preliminary method work suggesting that in five–day exposures

sta rvation threshold existed between 1.2 and 2.3 g/day food consumption per bird. Data were not available to confirm the starvation feeding level. By reducing exposure to 24-h in this study, however, even birds that ate less than 1.0 grams had good (90 %) survival. With such a short exposure, the resulting endpoint calculations were not useable for risk assessment without substantiating the starvation level or the trend over more than one day (i.e., birds feeding above the starvation rate on the first day might reduce feed consumption subsequently, thus possibly underestimating effects). A significant reduction in feed consumption was measured, but, again the results could not be quantifiably extrapolated to a 5-day exposure endpoint and therefore, the

re sults may be used only qualitatively to describe risk. As described above ( Section 4.1.2.1 ), arthropods and seeds in the study area may induce regurgitation and/or food avoidance which may lead to lower food intake. Since this exposure is expected to be patchy, rather than widespread (assuming no aerial spray and immediate incorporation), this may not be a problem on a population scale; however, the extent of the effect is unknown.

An earthworm fugacity evaluation was conducted to further analyze risks to birds, reptiles and terrestrial-phase amphibians through consumption of terrestrial invertebrates inhabiting the treated sites or indirect consumption through consuming other vertebrates that have consumed tainted invertebrates from the treatment sites (see Appendix D ). These calculations showed that food-borne uptake exposure does not produce LOC exceedences.

4.2.2. 2

. Mammals

Similar to birds, acute LOCs based on dose-based toxicity estimates were exceeded forlisted small, medium and large mammals feeding on arthropods. Chronic RQs based on dosebased toxicity were exceeded for all sizes of mammals feeding on arthropods. Chronic LOCs were exceeded based on dietary toxicity for mammals feeding on arthropods. The chronic LOC

is also exceed ed for mammals consuming arthropods from spray drift exposure. T 

### he probability

for acute direct effects to individual listed mammals at the highest derived RQ value range from

1 in 1 to 1 

### in 1.05E+17 . An estimated 3.3 f oot buffer is needed to remove the presumption of-Page 63 of 117-



### risk. Therefore, labeling language that would preclude spraying within 5 feet of a known feeding ground for listed mammals that consume seeds or arthropods is suggested.

An earthworm fugacity evaluation was conducted to further analyze risks to mammals through consumption of terrestrial invertebrates inhabiting the treated sites or indirect consumption through consuming other vertebrates that have consumed tainted invertebrates from the treatment sites (see Appendix D ). These calculations showed that food-borne uptake exposure does not produce LOC exceedences.

4.2.2.3. Terrestrial Invertebrates

Honeybees Fluensulfone is classified as practically non-toxic to honey bees on an acute contact and

ora l exposure basis, based on available data for the TGAI and the 480EC formulation. T 

### he probability for acute direct effects to individual listed invertebrates at the highest derived RQ

value was 1 in 1.

Earthworms

T he mandatory soil incorporation for two of the proposed application methods likely increases fluensulfone exposure to the earthworm. A very rough comparison of exposure from TREX dietary EECs show fluensulfone to be in various parts of the environment in concentrations from about 50-850 ppm. With acute toxicity to the earthworm occurring at roughly 50-150 ppm and chronic around 10 -50 ppm, this line of reasoning indicates potential for toxicity to earthworms from the proposed use. Additionally, the target taxon, nematodes, has a somewhat similar life history to that of the annelids.

An earthworm fugacity evaluation was conducted to further analyze risks to terrestrial invertebrates inhabiting the treated sites (see Appendix D ). These calculations indicated that exposure through incorporation or drip-irrigation from 1-15 cm down into the soil does not exceed Agency LOC for listed invertebrates (0.05).

Conclusions from TREX and fugacity evaluations were not consistent. The major uncertainty seems to be the concentrations within the soil to which earthworms are exposed. TREX calculations represent exposure at the top of the soil column and the fugacity model within the soil column to a depth of 15cm. The fugacity model likely better estimates exposure to earthworms, and the TREX model exposure to above ground invertebrates.

Beneficial insects

If the TREX estimate of the EEC for arthropods (52 ppm) is compared to the toxicity endpoints for beneficial insects, reproduction was impaired in the predatory mite, green lacewing and ground-active beetle at soil concentrations of about 10-100 ppm. The acute endpoints for the

pre datory mite and parasitic wasp were expressed as lbs a.i./A and ranged from 0.0145 to 0.892 lb a.i./A. With the application rate of 3.5 lb a.i./A exceeding these endpoints by roughly 4 to 200x, cle arly, above-ground beneficial insects in the treatment area are at risk.-Page 64 of 117- 

### 4.2.2.4

. Terrestrial Plants

Terrestrial plants inhabiting dry areas were not determined to be at any significant risk

from the proposed use of fluensulfone to control nematodes on Crop Groups 8 and 9. Semiaquat ic dicots were determined to be at risk if exposure occurs. However, since spray-drift exposure does not pose a significant risk, exposure is unlikely unless by either aerial application or failure to incorporate soon enough to prevent runoff. Therefore, label statements preventing aerial application and ensuring immediate incorporation would likely reduce this risk.



# 5 . Federally Threatened and Endangered (Listed) Species

Concerns

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, and/or the United States Fish and Wildlife Service (USFWS, 2011 )

for li sted wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated critical habitat. Each federal agency is required under the Act to ensure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat. To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species" (50 C.F.R. § 402.02).

To facilitate compliance with the requirements of the Endangered Species Act (subsection (a)(2)), the Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly appreciably reduce the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species (USEPA, 2004). After the Agency’s screening level risk assessment is conducted, if any of the Agency’s listed species LOCs are exceeded for either direct or indirect effects, an analysis is conducted to determine if any listed

or c andidate species may co-occur in the area of the proposed pesticide use or areas downstream

or downwind that could be contaminated from drift or runoff/erosion. If listed or candidate species may be present in the proposed action area, further biological assessment is undertaken. The extent to which listed species may be at risk is considered, which then determines the need for the development of a more comprehensive consultation package, as required by the Endangered Species Act.

The federal action addressed herein is the proposed new registration of fluensulfone on

agr icultural and non-agricultural use sites. Given that fluensulfone can be used on both Crop Groups 8 and 9, it is expected that its use could occur nationwide.-Page 65 of 117-



### 5.1. Action Area

For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by fluensulfone use and not merely the immediate area where

fluensul fone is applied. At the initial screening-level, the risk assessment considers broadly

desc ribed taxonomic groups and conservatively assumes that listed species within those broad groups are co-located with the pesticide treatment area. This means that listed terrestrial plants and wildlife are assumed to be located on or adjacent to the treated site and listed aquatic organisms are assumed to be located in a surface water body adjacent to the treated site. The assessment also assumes that the listed species are located within an assumed area, which has the relatively highest potential exposure to the pesticide, and that exposures are likely to decrease

with distance from the treatment area. Section 3.1 of this risk assessment presents the proposed pesticide use sites that are used to establish initial co-location of species with treatment areas.

5.2

. Taxonomic Groups Potentially at Risk

If the assumptions associated with the screening-level action area result in RQs 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, RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect effects on listed species that depend upon the taxonomic group for which the RQ was calculated. However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential for a "may affect" conclusion exists and may be associated 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 are considered to determine the extent to which screening assumptions regarding an action area apply to a particular listed organism. These subsequent refinement steps will consider how this information would impact the action area for a particular listed organism and potentially include areas of exposure that are downwind and downstream of the pesticide use site.

Assess ment endpoints, exposure pathways, and the conceptual models addressing proposed new fluensulfone uses, and the associated exposure and effects analyses conducted for

the fluensulfone screening-level risk assessment are in Se ctions 2 to 3 . The assessment endpoints used in the screening-level risk assessment include those defined operationally as reduced survival and reproductive impairment for both aquatic and terrestrial animal species and survival, reproduction, and growth of aquatic and terrestrial plant species from both direct acute and chronic exposures. These assessment endpoints are intended to address the standard set forth in the Endangered Species Act requiring federal agencies to ensure that any action they authorize does not appreciably reduce the likelihood of both the survival and recovery of a listed

spec ies in the wild by reducing the reproduction, numbers, or distribution of the species. Risk estimates (RQs) which, integrating exposure and effects, are calculated for broad based taxonomic groups in the screening-level risk assessment presented in Section 4.-Page 66 of 117-



### Both acute listed species and chronic risk LOCs are considered in the screening-level risk assessment to identify direct and indirect effects to taxa of listed species. This section identifies direct effect concerns, by taxa, that are triggered by exceeding endangered LOCs in the screening-level risk assessment, with an evaluation of the potential probability of individual effects for exposures that may occur at the established endangered species LOC. Data on exposure and effects collected under field and laboratory conditions are evaluated to make determinations on the predictive utility of the direct effect screening assessment findings to listed species. Additionally, the results of the screen for indirect effects to listed species, using direct

eff ect acute and chronic LOCs for each taxonomic group, is presented and evaluated. Identified potential direct and indirect risks to listed species that may result from the proposed uses of

fluensulfone are summarized in Tab le 5 .1.

Table 5.1. Potential Direct and Indirect Effects to Federally Listed Taxa from Proposed

Use of Fl uensulfone to Control Nematodes on Crop Groups 8 and 9.

Listed Taxon Direct

Effects Uses of Concern Indirect

Effects c Uses of Concern

Terrestrial and semi

aquatic plants

- monocots No None No None

Terrestrial and semi

aquatic plants

- dicots Yes All uses No None

Birds Yes All uses Yes 1,2 ,3 All uses

Terrestrial

- phase amphibians Yes All uses Yes 1,2 ,3 All uses

Reptiles Yes All uses Yes 1,2 ,3 All uses

Mammals Yes All uses Yes 1,2 ,3 All uses

Terrestrial invertebrates Yes a All uses Yes 1 ,3 All uses Aquatic vascular and

non

- vascular plants Yes All uses No None

Freshwater fish No None Yes 2

, 4 All uses Aquatic

- phase amphibians No None Yes 2

, 4 All uses

Freshwater

invertebrates No All uses Yes 2

, 4 All uses

Freshwater m ollusks Yes b All uses Yes 2

, 4 All uses

Marine/estuarine fish No None Yes 2

, 4 All uses

Marine/estuarine

invertebrates No All uses Yes 2

, 4 All uses

Marine/estuarine

m olluscs Yes b All uses Yes 2

, 4 All uses

Sediment

- dwelling organisms No None Yes 2

, 4 All uses

a The LOC exceedance was based on lines of evidence including application rate, toxicity data (both pollinators and beneficial insects), and the mode of action of fluensulfone.

b .Based on exposure from spray drift.

c Potential indirect effects on a taxon attributable to:

1 Direct acute and chronic effects on birds and mammals.

2 Direct acute and chronic effects on aquatic invertebrates.

3 Direct effects to terrestrial plants (dicots).

4 Direct effects to aquatic plants.-Page 67 of 117-



### 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 individual listed species and aquatic animals that may indirectly affect the listed species of concern (USEPA, 2004). As part of this evaluation, the acute RQ for listed species is presented in terms of the chance of an individual event ( i.e. , mortality or immobilization) should exposure at the EEC actually occur for a species with sensitivity to fluensulfone on par with the acute toxicity endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses the slope of the dose-response relationship available from the toxicity study used to establish the acute toxicity measures of effect for each taxonomic group that is relevant to this assessment. The individual effects probability associated with the acute RQ is based on the mean estimate of the slope and an assumption of a probit dose-response relationship. In addition to a single effects probability estimate based on the mean, upper and lower estimates of the effects probability are also provided to account for variance in the slope, if available. Based on the available acute toxicity for fluensulfone, a summary of the probit dose- re sponse analysis is provided in Table 6 .2 . If no dose response information is available to estimate a slope for this analysis, a default slope assumption of 4.5 (with lower and upper bounds of 2 to 9) (Urban and Cook, 1986) is used.

Individual effect probabilities are calculated based on an Excel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) developed by the U.S. EPA, OPP, Environmental Fate and Effects Division (June 22, 2004). The model allows for such calculations by entering the mean slope estimate (and the 95% confidence bounds of that estimate) as the slope parameter for the spreadsheet. The desired threshold for the probability of an individual effect is entered as the listed species LOC. In addition, the probability of an individual effect is also derived based

on the calculated acute RQ, if available.

Table 5.2. Summary of Fluensulfone Probit Dose Response Analysis for Listed Species (Based on the Proposed Use on Crop Groups 8 and 9)

Taxa (study type) Acute Effect

Slope (95% C.I.) 1 Associated RQs Chance of Individual

Effect at Listed Species LOC (95% C.I.) 1 Chance of Individual

Effect at Derived Acute RQ (95% C.I.)

Bird (oral dose) Bobwhite LD 50 = 998 (791

- 1260) Slope: 6.08 (3.10

- 9.07)

48574951 Weight Gain

Inhibition

Mallard NOAEC =

255

48574846 7.25

- 0.40

3.29

- 1.29 1 in 1.66E+09

(1 in 1.03E+03 to 1 in 1.68E+19) 1 1 in 1.00 (1 in 1.00 to 1 in 1.00)

to
1 in 1.05E+17 (1 in 1.36E+05 to 1 in 2.60E+36)

Bird (dietary) 2 Bobwhite LC 50 >5930

mg a.i./kg

- diet

48574844 >0.15 1 in 2.94E+05 (1 in 4.40E+01 to 1 in 8.86E+18) >1 in 9.56E+03

(>1 in 2.01E+01 to >1 in 1.65E+13) Mammal (oral Rat LD 50 671 mg 0.54

- 0.10 1 in 2.94E+05 1 in 8.75

- 2.94E+05-Page 68 of 117-

Taxa (study type) Acute Effect

Slope (95% C.I.) 1 Associated RQs Chance of Individual

Effect at Listed Species LOC (95% C.I.) 1 Chance of Individual

Effect at Derived Acute RQ (95% C.I.) dose) a.i./kg

- bw

48574745 (1 in 4.40E+01 to 1 in 8.86E+18)

H oneybee 48

- hr LD 50 = 167 μg

a.i./bee (766 mg ai/kg

bw) (141

- 210 μg a.i./bee,

647

- 963 mg ai/kg

- bw) Slope = 4.73 (2.80

- 6.66)

48574879 Arthropod

EEC = 329 mg ai/kg

diet bee=0.218g; Est RQ:0.43 (0.34

- 0.51) 1 in 8.91E+05

(1 in 3.91E+02 to 1 in 7.30E+10) 1 in 1.00 (1 in 1.00 to 1 in 1.00)

Freshwater fish (acute) Bluegill LC 50 2.5 mg

a.i./L 1

48574929 <0.01 (no

exc) 1 in 4.18E+08

(1 in 2.16E+02 to 1 in 1.75E+31) < 1 in 8.86E+18

Freshwater

invertebrates (acute) Immobilization and

sublethal effects Slope Daphnia magna 0.38 [ Slope = 3.19

95% C.I.: 2.18

- 4.19

48574930 0.026

- 0.030

(not exceed)

1 in 6.02E+04 (1 in

4.38E+02 to 1 in 4.00E+07) 1 in 4.68E+06 to 1 in

1.69E+06

Estuarine/marine fish (acute) SheepsheadLC 50 5.9 mg a.i./L 1
Use Default Slope

48574928 <0.01 (no

exc) 1 in 4.18E+08

(1 in 2.16E+02 to 1 in 1.75E+31) >1 in 8.86E+18

Estuarine/marine

invertebrates (acute) Mysid Mortality

LC 50 = 0.24 mg a.i./L 1

48574932 Mysid

1 in 4.18E+08 (1 in 2.16E+02 to 1 in 1.75E+31) --

1 The chance of individual effect at the listed species was calculated using the default slope of 4.5 (2 – 9) (unless another slope is listed), and the threshold of 0.05 (the listed species LOC).

2 Does not include the passerine data due to inadequacy.



### As shown in Table 5 .2

, the probability for acute direct effects ( i.e. , mortality) to individual listed fish at the highest derived RQ value is very low

, <1 in 8.86E+18. The probability for acute direct effects (i.e., mortality) to individual listed estuarine/marine

invertebrates is 1 in 4.18E+08 for the mysids exposed at the listed species LOC. The probability for acute direct effects ( i.e. , mortality) to individual listed freshwater invertebrates at the highest derived RQ value is 1 in 1.69E+06. T 

### he probability for acute direct effects to individual listed birds, mammals and bees at the highest derived RQ value range from 1 in 1 to 1 in 1.05E+17

.

5.2.2. Conclusions, Uncertainties and Potential Reduction Measures

Accordi ng to this screening-level ecological risk assessment, the proposed use of fluensulfone for nematode control on Crop Groups 8 and 9 result ed in LOC exceedances for:-Page 69 of 117-



### acute exposure of listed estuarine/marine invertebrates from runoff plus spraydrift, acute and chronic exposure of aquatic invertebrates and algae from runoff and spray drift; acute exposure of small and medium birds feeding on arthropods and contaminated

dri nking water; chronic exposure of birds and mammals consuming arthropods; acute exposure of listed small, medium and large mammals feeding on arthropods and contaminated drinking water ; exposure of beneficial insects and other terrestrial invertebrates; and exposure of listed aquatic non-vascular plants and semi-aquatic dicots.

Additionally: passerine risk could not be fully assessed due to inadequate data; risk to this group is uncertain since they can be more sensitive than other test species.

Potential indirect effects may also occur, including, but are not limited to, reduction in

food resources, decrease in cover, change in water quality parameters, and loss of breeding/nesting habitat. Identified potential direct and indirect risks to listed species that may result from the proposed uses of fluensulfone are summarized in Tab le 5 .1

. In addition, it is possible that adverse effects to terrestrial invertebrates, including pollinators and beneficial

inse cts, may occur, based on exposure to the 480EC formulated products in and around the use

areas of the proposed uses of fluensulfone.

Potential measures identified that would reduce environmental exposure or toxicity

inc lude:

re -formulation of the end-use product to bring down the formulated product toxicity, label specifications of low boom height and/or coarse droplet size and label specifications of buffer zones.

For reduction of LOC exceedences based on exposure from spray drift, an estimated 3 to

49 fo ot buffer would be needed to remove the presumption of risk to aquatic organisms (see

Table 5.2 ). Specifying a low boom and larger droplet size is also a feasible way to reduce risk and reduce the size of a protective buffer for aquatic organisms (also see Ap pendix B ):

3 foot buffer would protect aquatic plants 6 

### using high boom and fine droplets; no LOCs

were e xceeded with low boom and/or larger droplet sizes;

49 foot buffer would protect molluscs using high boom and fine droplets; 3 foot buffer if low boom used, and no buffer if coarse droplet size used.

6 The listed-species LOC was exceeded for non-vascular aquatic plants. However, no aquatic non-vascular plants are presently listed as endangered or threatened species in the US.-Page 70 of 117-



### 5. 2

. 3

. Listed Species Occurrence Associated with Fluensulfone Use

The goal of the co-location analysis is determine whether sites of pesticide use are geographically associated with known locations of listed species [following the convention of the Services, the word ‘species’ in this assessment may apply to a ‘species’, ‘subspecies’, or an Evolutionary Significant Unit (ESU)]. At the screening level, this analysis is accomplished using the LOCATES database (version 2.2.1). The database uses location information for listed species at the county level and compares it to agricultural census data (from 2007) for crop production at the same county level of resolution. The product is a listing of Federally-listed species that are located in counties known to produce the crops upon which the pesticide will be

used.

The results of this baseline-level risk assessment indicate that the proposed uses of fluensulfone have the potential for direct adverse acute effects on listed and non-listed freshwater fish (a surrogate for aquatic-phase amphibians); acute effects on listed freshwater invertebrates, estuarine/marine fish and invertebrates; chronic effects to freshwater fish and estuarine/marine invertebrates; acute effects on listed estuarine/marine fish and invertebrates (via spray drift from 480EC Formulation formulated product); and chronic effects on listed and non-listed mammals

base d on all proposed use patterns. Due to effects seen at the single application rate for both terrestrial monocot and dicot plant species in the seedling emergence and vegetative vigor toxicity tests, risk to terrestrial plants and animals with obligate relationships with plants are assumed. Although direct adverse effects to birds, terrestrial-phase amphibians, and reptiles, from fluensulfone use are not expected, indirect effects to these taxa are possible, given the

chr onic effects on mammals could indirectly impact terrestrial organisms that feed on these species. Therefore, all listed species occurring nationwide may potentially be affected by the proposed new registration of fluensulfone. Because there is a potential for indirect effects to all listed taxa and all proposed uses of fluensulfone may occur anywhere in the United States or its territories, state and county-level summaries from LOCATES are not provided. However, based on the U.S. Fish and Wildlife Services Endangered Species Program there are a total of 71 mammalian, 83 avian, 22 amphibian, 34 reptilian, 23 crustacean, 81 bivalve, 44 gastropod, 12 arachnid, 63 insect, 714 dicot, 28 fern, 3 conifers/cycads, 2 coral and 2 lichen listed species in

the United States that may be directly or indirectly affected by the proposed new uses of fluensulfone ( h ttp://www.fws.gov/endangered/species/us-species.html ). Listed fish species that may be indirectly affected were not tallied and the list was not culled for only birds and mammals in the feeding groups that are likely to be exposed (i.e., those feeding on arthropods in the treated area and/or seeds or grains that drift into the treated area).

This preliminary analysis indicates that there is a potential for fluensulfone use to overlap

with l isted species.-Page 71 of 117-



# 6. References

Burns, L.A. 2004. Exposure Analysis Modeling System (EXAMS): User Manual and System Documentation. Revision G. EPA/600/R-00/081. National Exposure Research Laboratory, Office of Research and Development, U.S. Environmental Protection Agency, Research Triangle Park, NC. May, 2004.

Carousel, R.F., J.C. Imhoff, P.R. Hummel, J.M. Cheplick, A.S. Donigian, Jr., L.A. Suarez. Undated. PRZM-3, A Model for Predicting Pesticide and Nitrogen Fate in the Crop Root

and Unsaturat ed Soil Zones: Users Manual for Release 3.12.2. National Exposure Research Laboratory, Office of Research and Development, U.S. Environmental Protection Agency, Athens, GA; AQUA TERRA Consultants, Mountain View, CA; Waterborne Environmental, Inc., Leesburg, VA.

OECD Guideline 218, 2004. Test No. 218: Sediment-Water Chironomid Toxicity Using Spiked

Sedim ent

, Nov. 23

, 2004

. ISBN : 9789264070264. DOI :10.1787/9789264070264-en.http://www.oecdilibrary.org/docserver/download/9723501e.pdf?expires=1376322642&id= id&accname=guest&checksum=1A966B95D35F05C6E5296FBF4C091AFC

.

U. S. Environmental Protection Agency (USEPA). 1998a. Guidelines for Ecological Risk Assessment. EPA/630/R-95/002F. Published in 63 FR 26846; May 14, 1998. U.S.

Environm ental Protection Agency, Washington, DC. April, 1998.

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental 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. 2011 a

. Holman, E. Fluensulfone; Report of the Residues of Concern Knowledgebase Subcommittee (ROCKS). DP Barcode 388751. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs, Health Effects Division. Internal memorandum. Jul. 22, 2011.

USEPA. 2011 b . 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/water/

USEPA. 2012 a . Terrestrial Models. U.S. Environmental Protection Agency, Pesticides: Science and Policy, Models and Databases. Last updated March 22, 2012. Online at: http://www.epa.gov/oppefed1/models/terrestrial/#trex

.

USEPA. 2012 b

. ECOTOXicology Database System Version 4.0. U.S. Environmental Protection-Page 72 of 117-



### Agency, Office of Research and Development National Health and Environmental Effects

Resear ch Laboratory Mid-Continent Ecology Division (MED) Duluth, Minnesota. Last updated July 17, 2013. Online at: http://cfpub.epa.gov/ecotox/index.html

.

USEPA. 2013. Lin, J. Drinking Water Exposure Assessment for Proposed New Registration for uses on Cucurbits and Fruiting Vegetables. DP Barcode: 411774. U.S. Environmental Protection Agency, Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs, Ecological Fate and Effects Division. Internal memorandum. August 1, 2013

.

US FWS, U.S. Fish and Wildlife Services (2011). Endangered Species Program, U.S. Listed Species. Last updated September 1, 2011. Online at: http://www.fws.gov/endangered/species/us-species.html

.

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 Agency,

Office of Pesti cide Programs, Washington D.C.

Willis, G.H., and L.L. McDowell. 1987. Pesticide Persistence on Foliage in Reviews of Environmental Contamination and Toxicology. 100: 23 -73.

6.1. Submitted Product Chemistry and Environmental Fate Studies

MRID Citation MRID 48574709. Weissenfield, M. 2008d. MCW-2: Determination of the vapour pressure. Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works Ltd, Harlan L aboratories Study C00382, R

- 23313

MRID 48574710. Weissenfield, M. 2009. MCW-2: Henry’s Law constant – Expert statement. Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works Ltd, Harlan Laboratories Study C00516, R

- 23313A

MRID 48574715. Weissenfield, M. 2008a. MCW-2: Determination of water solubility. Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works Ltd,

Harlan Lab oratories Study C00415, R

- 23316

MRID 48574717. Weissenfield, M. 2008b. MCW-2: Determination of the partition coefficient (n -octanol / water). Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works Ltd, Harlan Laboratories Study C00426, R-23318

MRID 48574719. Weissenfield, M. 2008c. MCW-2: Calculation of dissociation constant. Harlan Laboratories Ltd, Zelgliweg 1, 4452 Itingen, Switzerland. Makhteshim Chemical Works Ltd, Harlan Laboratories Study C00527, R

- 23 321-Page 73 of 117-



### MRID 48574823. Moser F. 2011. Fluensulfone: Aerobic Degradation in Soils. Smithers Viscient AG Seestrasse 21, Postfach CH-9326 Horn, Switzerland. Makhteshim Chemical Works, Smithers Viscient AG Study 1026.014.760, R-27436,

MRID 48574824. Schick, M. 2011a. Anaerobic Soil Metabolism of [ 14 

### C]MCW-2. PTRL West, Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL West Report Number 1860W-1. Sponsor Study Code: R-23370

MRID 48574825. Ponte, M. 2012. Photodegradation of [ 14 

### C] MCW-2 in/on Soil by Artificial Light. PTRL West, Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL West Report Number 1856W 1, R-23320

MRID 48574823. Moser F. 2011. Fluensulfone: Aerobic Degradation in Soil. Smithers Viscient AG Seestrasse 21, Postfach CH-9326 Horn, Switzerland. Makhteshim Chemical Works, Smithers Viscient AG Study 1026.014.760, R-27436,

MRID 48574828. Brands, Ir. C. 2011a. Determination of the aerobic degradation rate of TSA in three soils. NOTOX B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. Makhteshim Chemical Works, Ltd. Notox Project 496681, R-28470

MRID 48574829. Brands, Ir. C. 2011b. Determination of the aerobic degradation rate of MS in three soils. NOTOX B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. Makhteshim Chemical Works, Ltd. Notox Project 496894, R-28472

MRID 48574824. Schick, M. 2011a. Anaerobic Soil Metabolism of [ 14 

### C]MCW-2. PTRL West, Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL West Report Number 1860W-1. Sponsor Study Code: R-23370

MRID 48574832. N ewcombe, A.C., Negley, T. And Everich, R. 2012. Dissipation of MCW-2 (Fluensulfone) in Soil under Bare Soil Conditions at Multiple Sites Across North America. ARCADIS, 3382 Capital Circle NE. Tallahassee, FL 32308. Makhteshim Chemical Works, Ltd. ARCADIS Rep No., R

- 23393.

MRID 48574833. LaMar J. and Quistad G.B. 2011a. Soil Adsorption/Desorption of [ 1 4 

### C]Fluensulfone (MCW

- 2) by the Batch Equilibrium Method. PTRL West, Inc., 625

- B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL West Report

Number 1844W

- 1, R

- 23337.

MRID 48575039. LaMar J. and Quistad G.B. 2011b. Soil Adsorption/Desorption of [ 14 

### C]Fluensulfone (MCW

- 2) by the Batch Equilibrium Method. PTRL West, Inc., 625

- B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL West Report No.

2081W: R23333-Page 74 of 117-



### MRID 48574834. Brands, Ir. C. 2011c. Adsorption/Desorption of TSA on five soils. NOTOX

B.V ., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. Makhteshim Chemical Works, Ltd. NOTOX Project 496682, R-28473

MRID 48574835. Brands, Ir. C. 2011d. Adsorption/Desorption of MS on five soils. NOTOX B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. Makhteshim Chemical Works, Ltd. NOTOX Project 496850, R-28475

MRID 48574836. Brands, Ir. C. 2011e. Adsorption/Desorption of BSA on five soils. NOTOX B.V., Hambakenwetering 7, 5231 DD 's-Hertogenbosch, The Netherlands. Makhteshim Chemical Works, Ltd. NOTOX Project 496851, R-28474

MRID 48574718. Shepler K. 2010. Hydrolysis of [ 14 

### C ]MCW-2 (Fluensulfone) at pH 4, 7 and 9. PTRL West, Inc. 625-B Alfred Nobel Drive Hercules, CA 94547. Makhteshim Chemical Works, Ltd. PTRL West Report No. 1843-001, R-23319

MRID 48574840. Quistad G. B and Bronner B. 2011. Anaerobic Aquatic Metabolism of [ 14 

### C]MCW-2. PTRL West, Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works. PTRL West Report Number 1855W-1, R-23381

MRID 48574839. Hiler T. and. Duncan T. M. 2011. Aerobic Aquatic Metabolism of [ 14 

### C] MCW-2. PTRL West, Inc., 625-B Alfred Nobel Drive, Hercules, CA 94547. Makhteshim Chemical Works. PTRL West Report Number 1857W-1, R-23380

MRID 48575016. Feil, N . 2011. Ready biodegradability of MCW-2 in a closed bottle test. Institute für Biologische Analytic und Consulting IBACON GmbH. Arheilger Weg 17, 64380 Rossdorf, Germany. Makhteshim Chemical Works, Ltd. Report No. 63711161. R-23406.

MRID 48574849. Schick M, 2011. Photodegr adation of [ 14 

### C]MCW

- 2 in Sterilized pH 7 Buffer and Natural Water by Artificial Sunlight. PTRL West, Inc. 625

- B Alfred Nobel Drive Hercules,

CA 94547. Makhteshim Chemical Wo rks, Ltd. Report No.: Report no. 1843W

- 001, R

- 23322

6.2. Submitted Ecotoxicity Studies

MRID Citation MRID 48574842 Hubbard, P.M., Beavers, J.B. MCW-2 Technical: An acute oral toxicity study with the Northern Bobwhite Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234-104. R-23384

MRID 48574843 H ubbard, P.M.; Beavers, J.B. MCW2 Technical: An acute oral toxicity study with the canary ( serinus canaria ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234-110. R-23437-Page 75 of 117-



### MRID 48574844 Hubbard, P.M., Martin, K.H., Beavers, J.B. MCW-2 Technical: A dietary LC50 study with the Northern Bobwhite Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife

Int ernational Ltd Project No. 234-102. R-23387

MRID 48574845 H ubbard, P.M.; Martin, K.H.; Beavers, J.B. MCW-2 Technical: A dietary LC50 study with the Mallard. Wildlife International, LTD, 8598 Commerce Drive, Easton,

Mar yland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234-103. R-23388

MRID 48574846 Tem

ple, D.L.; Martin, K.H.; Beavers, J.B.; Jaber, M. MCW-2 Technical: A reproduction study with the Mallard. Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife

Int ernational Ltd Project No. 234-115. R-23439

MRID 48 574847 Temple, D.L.; Martin, K.H.; Beavers, J.B.; Jaber, M. MCW-2 Technical: A reproduction study with the Northern Bobwhite. Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234-114. R-23438

MRID 48574850 Gallagher, S.P. MCW-2 Technical: A 96-Hour static acute toxicity test with the rainbow trout ( Oncorhynchus mykiss ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America. Wildlife

Int ernational Ltd Project No. 234A-104. R-23440.

MRID 48574851 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour static acute toxicity test with Common Carp (Cyprinus carpio). Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of

North A merica Wildlife International Ltd Project No. 234A-116. R-23374.

MRID 48574852 G allagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour static acute toxicity test with Sheepshead Minnow ( Cyprinodon variegatus ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-105. R-23390

MRID 48574853 G allagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour static acute toxicity test with Bluegill ( Lepomis macrochirus ). Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North

Am erica Wildlife International Ltd Project No. 234A-103. R-23391

MRID 48574854 G allagher, S. P. MCW-2 Technical: An early life-stage toxicity test with Fathead Minnow (Pimephales promelas) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife

Int ernational Ltd Project No. 234A-118. R-23392-Page 76 of 117-



### MRID 48574855 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW2 Technical: Results of a

48 -hour static acute toxicity test with Daphnia magna Definitive Trial 2 (Definitive test results

not a udited by Quality Assurance). Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-102A. R-23409

MRID 48574856 Gallagher, S.P.; Minderhout, T.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A flow-through Life-cycle toxicity test with the cladoceran ( Daphnia magna ).

W ildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822

-8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-117. R23394

MRID 48574857 Claude, M.B.; Kendall, T.Z.; Krueger, H.O. MCW2 technical: A flowthrough life-cycle toxicity test with the saltwater mysid ( Americamysis bahia ). Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-120. R-23447

MRID 48574858 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour toxicity test with the freshwater alga. ( Pseudokirchneriella subcapitata ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-109. R-23441

MRID 48574859 Porch, J.R.; Kendal l, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour

toxi city test with the freshwater alga. ( Anabaena flos-aquae ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North

Am erica Wildlife International Ltd Project No. 234A-121. R-23460

MRID 48574860 Porch, J.R.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour

toxi city test with the freshwater diatom ( Navicula pelliculosa ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North

Am erica Wildlife International Ltd Project No. 234A-122. R-23445

MRID 48574861 Porch, J.R.; Kendal l, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour

toxi city test with the marine diatom ( Skeletonema costatum ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North

Am erica Wildlife International Ltd Project No. 234A-123. R-23446

MRID 48574862 Tho mas, S.T.; Kendall, T.Z.; Krueger, H.O. MCW2 Technical: a 10-day survival and growth sediment toxicity test with Chironomus tentans using spiked sediment Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822

-8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-119. R23413.-Page 77 of 117-



### MRID 48574863 Gallagher, S.P. MCW-2 Technical: A 7-day static-renewal toxicity test with Duckweed (Lemna gibba G3) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-108. R-23443.

MRID 48574864 G allagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 Technical: A 96-hour static acute toxicity test with Saltwater Mysid (Americamysis bahia). Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-106. R-23405

MRID 48574865 G allagher, S.P. MCW-2 Technical: A 96-hour shell deposition test with the Eastern oyster (Crassostrea virginica) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-107. R-23408.

MRID 48574866 G allagher, S.P.; Kendall, T.Z.; Krueger, H.O. Thiazole sulfonic acid: a 96- hour static acute toxicity test with the bluegill. ( Lepomis macrochirus ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-137. R-27469

M RID 48574868 Jacobs, A.M.; Porch, J.R.; Kendall, T.Z.; Krueger, H.O. Thiazole sulfonic acid: A 96-hour toxicity test with the freshwater alga ( Pseudokirchneriella subcapitata ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-132. R-27470

MRID 48574869 G allagher, S.P.; Kendall, T.Z.; Krueger, H.O. Thiazole sulfonic acid: a 96- hour static acute toxicity test with the saltwater mysid ( Americamysis bahia ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-138. R-27468

MRID 48574870 G allagher, S.P.; Kendall, T.Z.; Krueger, H.O. Butene sulfonic acid: a 96-hour static acute toxicity test with the bluegill. ( Lepomis macrochirus ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-136. R-23493

MRID 48574872 Butene sulfonic acid: A 96-hour toxicity test with the freshwater alga ( Pseudokirchneriella subcapitata ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project

No. 234A -126. R-23494

MRID 48574873 G allagher, S.P.; Kendall, T.Z.; Krueger, H.O. Butene sulfonic acid: a 96-hour static acute toxicity test with the saltwater mysid ( Americamysis bahia ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-125. R-23492-Page 78 of 117-



### MRID 48574874 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. Methyl sulfone: A 96-hour static acute toxicity test with the bluegill. ( Lepomis macrochirus ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-139. R-27464

MRID 485748 76 Porch, J.R.; Kendall, T.Z.; Krueger, H.O. Thiazole methyl sulfone: A 96-hour toxicity test with the freshwater alga ( Pseudokirchneriella subcapitata ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-135. R-27465

MRID 48574877 G allagher, S.P.; Kendall, T.Z.; Krueger, H.O. Methyl sulfone: A 96-hour static acute toxicity test with the saltwater mysid ( Americamysis bahia ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-140. R-27463

MRID 48574878 Jacob s, A.M.; Porch, J.R.; Kendall, T.Z.; Krueger, H.O. Deschlorofluensulfone: A 96-hour toxicity test with the freshwater alga ( Pseudokirchneriella subcapitata ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-134. R-27472

MRID 48574879 Zenker , K. Acute toxicity of MCW-2 TECH to the honeybee Apis mellifera L. Under laboratory conditions. Makhteshim Agan of North America BioChem agrar, Labor für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. BioChem Project No: 09 10 48 011 B, R-23398

MRID 48574880 Friedrich, S. Acute toxicit y of MCW-2 technical to the earthworm Eisenia fetida in artificial soil with 5% peat. Makhteshim Agan of North America BioChem agrar, Labor für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany.

BioChe m Project No: 09 10 48 030 S, R-23401.

MRID 48574881 Sinderm ann, A.B.; Porch, J.R.; Krueger, H.O. Thiazole sulfonic acid: an acute toxicity study with the earthworm in an artificial soil substrate Makhteshim Agan of North America Wildlife International, Ltd., 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-

410 -822-8600. Wildlife International Ltd. Project No: 234-122. R-27471

MRID 48574882 Sinderm ann, A.B.; Porch, J.R.; Krueger, H.O. Butene sulfonic acid: an acute toxicity study with the earthworm in an artificial soil substrate Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-

410 -822-8600. Wildlife International Ltd Project No. 234-121. R-23495

MRID 48574883 Sinderm ann, A.B.; Porch, J.R.; Krueger, H.O. Methyl sulfone: An acute toxicity study with the earthworm in an artificial soil substrate Makhteshim Agan of North America Wildlife International, Ltd., 8598 Commerce Drive, Easton, Maryland 21601 Wildlife-Page 79 of 117-



### International Ltd. Project No: 234-123. R-27466

MRID 48574910 G rande, A. Determination of the non target effects on the bumble bees Bombus sp. [Hymenoptera: Aphidae] following a single application of MCW-2 EC (by drip irrigation before seedlings transplanting) or following two applications of Nemacur 240 CS (by drip irrigation before and after seedlings transplanting) on tomato – one trial in southern Europe (Italy) - 2010 Makhteshim Agan of North America SAGEA Centro di Saggio s.r.l., Via S.

Sudari o, 13-12050 Castagnito d’Alba (CN), Italy SAGEA Project No.: 3446610, R-29571

MRID 48574927 Gallagher, S.P. MCW-2 480 EC: A 96-hour static acute toxicity test with Rainbow Trout ( Oncorhynchus mykiss ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North America Wildlife

Int ernational Ltd Project No. 234A-112. R-23363

MRID 48574928 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 480 EC: A 96 -hour static acute toxicity test with Sheepshead Minnow ( Cyprinodon variegatus ) Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Wildlife International Ltd Project No. 234A-113. R-23364 GLP, not publi shed.

MRID 48574929 Gallagher, S.P. MCW-2 480 EC: A 96-hour static acute toxicity test with the Bluegill ( Lepomis macrochirus). Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Wildlife International Ltd Project No. 234A-111. R-23368. GLP, not published.

MRID 48574930 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O MCW-2 480 EC: A 48-hour

sta tic acute toxicity test with the cladoceran ( Daphnia magna ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Makhteshim Agan of North

Am erica Wildlife International Ltd Project No. 234A-110. R-23367

MRID 48574931 Jacobs, A.M., Porch, J.R.,Kendall,T.Z., Krueger, H.O. Fluensulfone 480EC: A 96-hour toxicity test with the freshwater alga ( Pseudokirchneriella subcapitata ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600.Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-133C. R23499

MRID 48574932 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 480 EC: A 96-hour

sta tic acute toxicity test with Saltwater Mysid ( Americamysis bahia ) Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-

410 -822-8600. Wildlife International Ltd Project No. 234A-114A. R-23365.

MRID 48574933 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. MCW-2 480 EC: A 96-hour

shel l deposition test with the Eastern oyster ( Crassostrea virginica ) Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1--Page 80 of 117-



### 410 -822-8600. Wildlife International Ltd Project No. 234A-115. R-23378.

MRID 48574934 Zenker, K. Acute toxicity of MCW-2 480 EC to the honeybee Apis mellifera L. Under laboratory conditions. Makhteshim Agan of North America BioChem agrar, Labor für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. BioChem Project No: 09 10 48 010 B, R-23371.

MRID 48574935 Fallow field, L. A rate-response laboratory bioassay to determine the effects of fresh residues of MCW-2 480 EC on the predatory mite, Typholodromus pyri (Acari: Phytoseiidae) Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture Road, Chilworth Science Park, Southampton SO16 7NP Study No. MAK-09-1, R-23399

MRID 48574936 Stevens, J. A rate-response extended laboratory bioassay to determine the effects of fresh residues of MCW-2 480 EC on the parasitic wasp, Aphidus rhopalosophi (Hymenoptera, Braconidae) Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture Road, Chilworth Science Park, Southampton SO16 7NP Study No. MAK-09-2, R-23400

MRID 48574937 Vinall, S. A rate-response laboratory bioassay to determine the effects of fresh residues of MCW-2 480 EC on predatory mite, Hypoaspis aculeifer (Acari, Laelapidae) Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture Road, Chilworth Science Park, Southampton SO16 7NP Study No. MAK- 09 -3, R-23359

MRID 48574938 Spincer, D. A rate-response extended laboratory bioassay to determine the

eff ects of fresh residues of MCW-2 480 EC on the ground-active beetle, Aleochara bilineata (Coleoptera; Staphylinidae) Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture Road, Chilworth Science Park, Southampton SO16 7NP Study No. MAK-09-5, R-23361

MRID 48574939 Friedrich, S. Acute toxicity of MCW-2 480 EC to the earthworm Eisenia fetida in artificial soil with 5% peat. Makhteshim Agan of North America BioChem agrar, Labor

für biol ogische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. BioChem Project No: 09 10 48 032 S, R-23377

MRID 48574940 Friedrich, S. Sublethal toxicity of MCW-2 480 EC to the earthworm Eisenia fetida in artificial soil with 5% peat. Makhteshim Agan of North America BioChem agrar, Labor für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. BioChem Project No: 09 10 48 031 S, R-23402

MRID 48574941 V inall, S. A rate-response laboratory bioassay to determine the effects of fresh residues of MCW-2 480 EC on springtail, Folsomia candida (Collembola, Isotomidae Makhteshim Agan of North America Mambo-Tox Ltd., 2 Venture Road, Chilworth Science Park, Southampton SO16 7NP Study No. MAK- 09 -4, R-23360

MRID 48574942 Schulz, L. MC W-2 480EC. Effects on the activity of soil microflora (Nitrogen and carbon transformation tests) Makhteshim Agan of North America BioChem agrar,-Page 81 of 117-



### Labor für biologische und chemishe Analytic Gmbh, Kupferstrasse 6, 04827 Gerichshain, Germany. BioChem Project No: 09 10 48 017 C/N, R-23403

MRID 48574943 Porch, J.R.; Kruege r, H.O.; Kendall, T.Z. MCW-2 480 EC: A toxicity test to determine the effects of the test substance on vegetative vigour of ten species of plants Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Wildlife International Ltd Project No. 234-109.

R -23436

MRID 48574944 Porch, J.R.; Martin, K.H.; Krueger, H.O. MCW-2 480 EC: A toxicity test to determine the effects of the test substance on seedling emergence of ten species of plants. Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Wildlife International Ltd Project No. 234-108.

R -23435

MRID 48574945 Porch, J.R.; Krueger, H.O.; Kendall, T.Z. MCW-2 480 EC: A toxicity test to determine the effects of the test substance on seedling emergence of ten species of plants. Makhteshim Agan of North America Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822-8600. Wildlife International Ltd Project No. 234-116.

R -23448

MRID 48574951 Hubbard, P.M.; Beavers, J.B. MCW-2 480 EC: An acute oral toxicity study with the Northern Bobwhite Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234-107. R-23450

MRID 48574957 Qingli Ma, Polakoff, B and Schocken, M. Fluensulfone (MCW-2): US Ecologi cal Risk Assessments, Exponent, Inc. 1150 Connecticut Avenue, NW, Suite 1100, Washington, D.C. 20036 Makhteshim Chemical Works Report WD01184.002 EWC 100.

MRID 48574958 Qingli Ma, Polakoff, B and Schocken, M. Fluensulfone (MCW-2): Ecologi cal Risk Assessments for Canada, Qingli Ma, Polakoff, B and Schocken, M, Exponent, Inc. 1150 Connecticut Avenue, NW, Suite 1100, Washington, D.C. 20036 Makhteshim Chemical Works Report WD01184.002 EWC 110.

MRID 48575017 Porch, J.R.; Kendall, T.Z.; Krueger, H.O. Fluensulfone TGAI: A 96-hour toxicity test with the freshwater alga ( Pseudokirchneriella subcapitata ) W ildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-131. R-23496

MRID 48575019 Jacob s,A., Proch, R., Kendall, T., Kreueger, H. Fluensulfone TGAI: A 96- hour toxicity test with the freshwater alga ( Scenedesmus subspicatus ) Wildlife International, LTD, 8598 Commerce Drive, Easton, Maryland 21601 USA, 1-410-822 -8600. Makhteshim Agan of North America Wildlife International Ltd Project No. 234A-130. R-23497.-Page 82 of 117--Page 83 of 117-



## Appendix A. Aquatic Model Input/Output Data.

Example Input/Output Data for Individual Simulations

PE5 (PRZM-EXAMS) Output File for Parent (surface water)

stored as FlFLCUn.out

Chemical: Fluensulfone PRZM environment: FLcucumberSTD.txt modified Tueday, 26 August 2008 at 06:16:38 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06:14:08 Metfile: w12844.dvf modified Tueday, 26 August 2008 at 06:14:22 Water segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 2.681 2.54 2.13 1 .653 1.336 0.3633

1962 3.827 3.714 3.079 2.296 1.914 0.5746

1963 4.638 4.409 3.816 2.891 2.321 0.7152

1964 7.321 7.081 6.175 4.723 3.791 1.116

1965 1.964 1.862 1.604 1.317 1.082 0.4198

1966 20.29 19.56 17.69 12.21 9.593 2.626

1967 3.791 3.609 3.03 2.433 1. 988 0.8398

1968 7.791 7.402 6.674 4.929 3.939 1.145

1969 5.082 4.928 4.457 3.248 2.613 0.8587

1970 5.223 4.989 4.238 2.933 2.419 0.7659

1971 5.064 4.812 4.134 2.989 2.384 0.7346

1972 4.624 4.373 3.5 2.395 1.901 0.5745

1973 6.763 6.414 5.695 4.077 3.199 0.9119

1974 7.268 6.884 5.657 3.927 3.122 0.9274

1975 5.759 5.468 4.568 3.226 2.65 0.8194

1976 8.706 8.368 6.944 5.088 4.075 1.212

1977 43.74 42.28 35.43 24.04 18.82 5.208

1978 7.901 7.512 6.186 4.239 3.347 1.479

1979 14.75 14.34 13.36 9.428 7.401 2.09

198 0 12.28 11.81 9.866 6.764 5.289 1.649

1981 8.778 8.347 7.232 4.986 3.96 1.245

1982 3.358 3.197 2.692 2.035 1.613 0.5675

1983 3.582 3.396 2.788 2.368 1.916 0.5695

1984 4.314 4.142 3.806 2.954 2.38 0.7106

1985 5.292 5.06 4.302 3.36 2.678 0.7986

1986 7.862 7.434 5.965 3.951 3.082 0.9044

1987 5.62 5.329 4.479 3.375 2.732 0.82

1988 2.012 1.899 1.609 1.249 1.018 0.3676

1989 3.876 3.695 3.169 2.502 1.993 0.57

1990 6.314 5.98 5.247 4.016 3.204 0.9228

Sorted results

Prob. Peak 96 hr 21 Day 60 Day 90 Day Yearly

0.03 2258064516129 43.74 42.28 35.43 24.04 18.82 5.208

0.0645161290322581 20.29 19.56 17.69 12.21 9.593 2.626

0.0967741935483871 14.75 14.34 13.36 9.428 7.401 2.09

0.129032258064516 12.28 11.81 9.866 6.764 5.289 1.649

0.161290322580645 8.778 8.368 7.232 5.088 4.075 1.479

0.193548387096774 8.706 8.347 6.944 4.986 3.96 1.245

0.225806451612903 7.901 7.512 6.674 4.929 3.939 1.212

0.258064516129032 7.862 7.434 6.186 4.723 3.791 1.145

0.290322580645161 7.791 7.402 6.175 4.239 3.347 1.116

0.32258064516129 7.321 7.081 5.965 4.077 3.204 0.9274

0.354838709677419 7.268 6.884 5.695 4.016 3.199 0.9228

0.387096774193548 6.763 6.414 5.657 3.951 3.122 0.9119-Page 84 of 117-

0.419354838709677 6.314 5.98 5.247 3.927 3.082 0.9044

0.451612903225806 5.759 5.468 4.568 3.375 2.732 0.8587

0.4838709677 41936 5.62 5.329 4.479 3.36 2.678 0.8398

0.516129032258065 5.292 5.06 4.457 3.248 2.65 0.82

0.548387096774194 5.223 4.989 4.302 3.226 2.613 0.8194

0.580645161290323 5.082 4.928 4.238 2.989 2.419 0.7986

0.612903225806452 5.064 4.812 4.134 2.954 2.384 0.7659

0.645161290322581 4.638 4.409 3.816 2.933 2.38 0.7346

0.67741935483871 4.624 4.373 3.806 2.891 2.321 0.7152

0.709677419354839 4.314 4.142 3.5 2.502 1.993 0.7106

0.741935483870968 3.876 3.714 3.169 2.433 1.988 0.5746

0.774193548387097 3.827 3.695 3.079 2.3 95 1.916 0.5745

0.806451612903226 3.791 3.609 3.03 2.368 1.914 0.57

0.838709677419355 3.582 3.396 2.788 2.296 1.901 0.5695

0.870967741935484 3.358 3.197 2.692 2.035 1.613 0.5675

0.903225806451613 2.681 2.54 2.13 1.653 1.336 0.4198

0.935483870967742 2.012 1 .899 1.609 1.317 1.082 0.3676

0.967741935483871 1.964 1.862 1.604 1.249 1.018 0.3633

0.1 14.503 14.087 13.0106 9.1616 7.1898 2.0459 Average of yearly averages: 1.08353666666667

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run: Output File: FlFLCUn

Metfile: w12844.dvf

PRZM scenario: FLcucumberSTD.txt

EXAMS environment file: pond298.exv

Chemical Name: Fluensulfone Description Variable Name Value Units Comments Molecular weight mwt 291.7 g/mol
Henry's Law Const. henry 1.65e

- 7 atm

- m ^3/mol

Vapor Pressure vapr torr Solubility sol 545.3 mg/L

Kd Kd mg/L

Koc Koc 192 mg/L
Photolysis half-life kdp 0.784 days Half-life Aerobic Aquatic Metabolism kbacw 45.93 days Halfife Anaerobic Aquatic Metabolism kbacs 27.68 days Halfife

Aerobic Soil Met abolism asm 11.98 days Halfife Hydrolysis: pH 7 0 days Half

- life

Method: CAM 4 integer See PRZM manual Incorporation Depth: DEPI 15 cm Application Rate: TAPP 3.92 kg/ha
Application Efficiency: APPEFF 0.99 fraction Spray Drift DRFT 0.01 fraction of applicat ion rate applied to pond Application Date Date 01

- 09 dd/mm or dd/mmm or dd-mm or dd

- mmm
Record 17: FILTRA

IPSCND 1

UPTKF

Record 18: PLVKRT

PLDKRT

FEXTRC 0.5
Flag for Index Res. Run IR EPA Pond
Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)



### PE 5 (PRZM-EXAMS) Output File for Parent (sediment pore water)

stored as FlFLCUnben.out

Chemical: Fluensulfone-Page 85 of 117-

PRZM environment: FLcucumberSTD.txt modified Tueday, 26 August 2008 at 06:16:38 EXAMS environment: pond298.exv modified Tueday, 26 August 2008 at 06:14:08

Metfile: w12844.dvf modified Tueday, 26 August 2008 at 06:14:22 Benthic segment concentrations (ppb)

Year Peak 96 hr 21 Day 60 Day 90 Day Yearly

1961 0.5137 0.5133 0.5055 0.461 0.4153 0.1203

1962 0.7458 0.7453 0.73 3 0.6783 0.6258 0.2159

1963 0.901 0.9005 0.887 0.8128 0.7395 0.2878

1964 1.486 1.486 1.463 1.336 1.203 0.4184

1965 0.6226 0.6082 0.5494 0.4286 0.3529 0.2025

1966 3.7 3.698 3.648 3.318 3.007 0.9186

1967 1.573 1.528 1.352 1.043 0.8625 0.4431

1968 1.516 1.515 1.494 1.38 1.268 0.4405

1969 1.018 1.018 1.001 0.9104 0.8326 0.371

1970 0.9477 0.947 0.9312 0.8591 0.7891 0.3141

1971 0.9223 0.9216 0.9066 0.8198 0.7344 0.291

1972 0.7283 0.7277 0.7147 0.6392 0.568 0.2139

1973 1.231 1.23 1.212 1.095 0.9743 0.3273

1974 1.197 1.196 1.178 1.078 0.9738 0.3518

1975 1.063 1.062 1.045 0.9545 0.8645 0.3198

1976 1.626 1.625 1.601 1.464 1.328 0.4687

1977 7.331 7.327 7.236 6.624 5.936 1.864

1978 2.825 2.764 2.516 2.03 1.712 0.8198

1979 2.879 2.877 2.832 2.566 2.297 0.7495

1980 2.053 2.051 2.023 1.827 1.638 0.6838

1981 1.57 1.569 1.543 1.408 1.286 0.5156

1982 0.7486 0.729 0.6511 0.5441 0.4866 0.2567

1983 0.7249 0.7244 0.7132 0.6531 0.5973 0.2164

1984 0.9371 0.9364 0.9211 0.8359 0.7537 0.2748

1985 1.039 1.038 1.018 0.9056 0.8023 0.2985

1986 1.194 1.193 1.174 1.05 0.9189 0.3335

1987 1.072 1.071 1.055 0.9597 0.8619 0.3124

1988 0.4566 0.4452 0.3993 0.3285 0.3021 0.1674

1989 0.7504 0.7499 0.7388 0.6728 0.6059 0.2044

1990 1.226 1.225 1.202 1.08 0.9663 0.3263

Sorted results

Prob. Peak 96 hr 2 1 Day 60 Day 90 Day Yearly

0.032258064516129 7.331 7.327 7.236 6.624 5.936 1.864

0.0645161290322581 3.7 3.698 3.648 3.318 3.007 0.9186

0.0967741935483871 2.879 2.877 2.832 2.566 2.297 0.8198

0.129032258064516 2.825 2.764 2.516 2.03 1.712 0.7495

0.161290322 580645 2.053 2.051 2.023 1.827 1.638 0.6838

0.193548387096774 1.626 1.625 1.601 1.464 1.328 0.5156

0.225806451612903 1.573 1.569 1.543 1.408 1.286 0.4687

0.258064516129032 1.57 1.528 1.494 1.38 1.268 0.4431

0.290322580645161 1.516 1.515 1.463 1.336 1.203 0.4405

0.32258064516129 1.486 1.486 1.352 1.095 0.9743 0.4184

0.354838709677419 1.231 1.23 1.212 1.08 0.9738 0.371

0.387096774193548 1.226 1.225 1.202 1.078 0.9663 0.3518

0.419354838709677 1.197 1.196 1.178 1.05 0.9189 0.3335

0.451612903225806 1.194 1.193 1.174 1.043 0.8645 0.3273

0.483870967741936 1.072 1.071 1.055 0.9597 0.8625 0.3263

0.516129032258065 1.063 1.062 1.045 0.9545 0.8619 0.3198

0.548387096774194 1.039 1.038 1.018 0.9104 0.8326 0.3141

0.580645161290323 1.018 1.018 1.001 0.9056 0.8023 0.3124

0. 612903225806452 0.9477 0.947 0.9312 0.8591 0.7891 0.2985

0.645161290322581 0.9371 0.9364 0.9211 0.8359 0.7537 0.291

0.67741935483871 0.9223 0.9216 0.9066 0.8198 0.7395 0.2878-Page 86 of 117-

0.709677419354839 0.901 0.9005 0.887 0.8128 0.7344 0.2748

0.741935483870968 0.7504 0.7499 0.7388 0.6783 0.6258 0.2567

0.774193548387097 0.7486 0.7453 0.733 0.6728 0.6059 0.2164

0.806451612903226 0.7458 0.729 0.7147 0.6531 0.5973 0.2159

0.838709677419355 0.7283 0.7277 0.7132 0.6392 0.568 0.2139

0.870967741935484 0.7249 0.7244 0.6511 0.5 441 0.4866 0.2044

0.903225806451613 0.6226 0.6082 0.5494 0.461 0.4153 0.2025

0.935483870967742 0.5137 0.5133 0.5055 0.4286 0.3529 0.1674

0.967741935483871 0.4566 0.4452 0.3993 0.3285 0.3021 0.1203

0.1 2.8736 2.8657 2.8004 2.5124 2.2385 0.81277 Average of yearly averages: 0.42426

Inputs generated by pe5.pl - Novemeber 2006

Data used for this run: Output File: FlFLCUn

Metfile: w12844.dvf

PRZM scenario: FLcucumberSTD.txt

EXAMS environment file: pond298.exv

Chemical Name: Fluensulfone Description Variable Name Value Units Comments Molecular weight mwt 291.7 g/mol
Henry's Law Const. henry 1.65e

- 7 atm

- m^3/mol

Vapor Pressure vapr torr Solubility sol 545.3 mg/L

Kd Kd mg/L

Koc Koc 192 mg/L
Photolysis half-life kdp 0.784 days Half-life Aerobic Aquatic Metabolism kbacw 45.93 days Halfife Anaerobic Aquatic Metabolism kbacs 27.68 days Halfife

Aerobic Soil Metabolism asm 11.98 days Halfife Hydrolysis: pH 7 0 days Half

- life

Method: CAM 4 integer See PRZM manual Incorporation Depth: DEPI 15 cm Application Rate: TAPP 3.92 kg/ha
Application Efficiency: APPEFF 0.99 fraction Spray Drift DRFT 0.01 fraction of application rate applied to pond Application Date Date 01

- 09 dd/mm or dd/mmm or dd-mm or dd

- mmm
Record 17: FILTRA

IPSCND 1

UPTKF

Record 18: PLVKRT

PLDKRT

FEXTRC 0.5
Flag for Index Res. Run IR EPA Pond
Flag for runoff calc. RUNOFF none none, monthly or total(average of entire run)-Page 87 of 117-



## Appendix B. AGDRIFT v.2.01 Output. Aquatic:

High Boom, Smallest Droplets

Fraction of Applied at Edge of Field. Distance Needed to Remove Presumption of Risk – as defined by endpoint divided by LOC (0.05 for Listed Animals; 1.0 for plants): For listed molluscs: For listed invertebrates: For Aquatic Plants:

Oy ster estimate (77000*0.05 = 3850). Mysid estimate ( 1 000000*0.05 = 50000 ). Algae estimate ( 1 1 000 *1 ).-Page 88 of 117-



### Buffer Needed using Daphnid Chronic Toxicity Data:



## Low Boo m: Smallest Droplets

Buffer Needed Based on Oyster Acute: Buffer Needed Based on Daphnid Chronic:-Page 89 of 117-



## High Boom: Large st

Droplets

Distance needed to remove Presumption of Risk: Oysters:-Page 90 of 117-



## Low Boom: Largest Droplets

Summary of AgDrift Calculations and Buffer Needed to Reduce the Presumption of Risk to

Below the LOC (0.05) for Listed Aquatic Species

Taxon and Type of Toxicity Data

Used as Basis Concentration

Estimate to

Remove Presumption of

Risk for Listed Species, as defined by the High Boom: Finest

Droplets Low Boom: Finest

Droplets High Boom: Fine

Med/Coarse Droplets Low Boom:

Fine

- Med/Coarse Droplets

Edge of

Field

Conc. Buffer

Needed,

ft Edge of

Field

Conc. Buffer

Needed,

ft Edge of

Field

Conc. Buffer

Needed,

ft Edge of

Field

Conc. Buffer Needed,

ft-Page 91 of 117- En dpoint*LOC Aquatic

Invertebrates: Oyster Acute

Data Mysid Acute

Data Daphnid

Chronic 77000 * 0.05 =

3850 ppt 12100

ppt,
0.216

lb/A 49

5260

ppt,
0.0938

lb/A 3

3240

ppt,
0.0577

lb/A 0

2140

ppt,
0.0381

lb/A 1000000 * 0.05

= 50000 ppt 0

96000 ppt (*1) 0

Aquatic Plants: Algal EC 05 11000 ppt (*1) 3 0

ppt = parts per trillion. Note: Calculated EECs (edge of field concentrations) based on parent compound a.i. but assuming equal toxicity with MS, calculations represent both.



## Terrestrial:

High Boom: Smallest Droplets

Low Boom: Smallest Droplets-Page 92 of 117-



## High Boom: Largest Droplets

Low Boom: Largest Droplets-Page 93 of 117-

Exposure to Terrestrial Animals From Varying Boom Heights and Droplet Sizes.

Taxon and Type of Toxicity Data

Used as Basis Concentration Estimate

to Remove Presumption

of Risk for Listed Species, as defined by the Endpoint*LOC High Boom:

Finest Droplets

HB/FD Low Boom: Finest

Droplets

LB/FD High Boom: Fine

Med/Coarse Droplets

HB/CD Low Boom:

Fine

- Med/Coarse Droplets

LB/CD

Birds:

Acute

Chronic 1510 mg/kg

- bw *0.1 =

151.0 mg/kg

- bw >5760 mg/kg

- diet *0.1 = >576.0 mg/kg

- diet

0.0414 mg/cm 2

, 3.69 lb/A 0.0400 mg/cm 2

,

3.57 lb/A 0.0397 mg/cm 2

,

3. 54 lb/A 0.0395 mg/cm 2

, 3.53 lb/A 255 mg/kg

- diet *0.1 = 25.5 mg/kg

- diet

Mammals:

Acute

Chronic 671 mg/kg

- bw *0.1

– 67.1

mg/kg

- bw 16.2 mg/kg

- bw *0.1=1.62 mg/kg

- bw 250 ppm *0.1=25 ppm

Bees 1 0.167 mg/bee ( 0.139

mg/cm 2 ) *0.05 = 0.00695 mg/ c m 2 0.0414 mg/cm 2 0.0400 mg/cm 2 0.0397 mg/cm 2 0.0395 mg/cm 2

Note: Calculated EECs (edge of field concentrations) based on parent compound a.i.; bird and mammal toxicity data based on most conservative, including consumers of grasses and other plants because even with incorporation and drip irrigation application, spray drift is one exposure route that may result in such exposure.

1 Assumed average honeybee to be approximately 90 to 140 mm 2 calculated from information from Smithsonian

website: http://www.issg.org/database/species/ecology.asp?si=325&fr=1&sts=sss . Used honeybee worker body length of 19 mm and ratio of body length to width of 3.0x (from average ratio of two bees measured in photos): 19mm * 6.3mm (19/3.0) = 119.7 mm 2 or 1.20 cm 2

. 2 EEC in mg/bee * bee/1.20 cm 2 (conversion) = EEC in mg/ cm 2

-- Example: 0.167 mg/bee * bee/1.20 cm 2 = 0.139 mg/cm 2

.



### HB/FD:-Page 94 of 117-



### LB/CD:-Page 95 of 117-

Distance Needed to Reduce the Presumption of Risk to Below the LOC (0.1) for Listed Species For Feeding Groups with LOC Exceedances Using Avian Dose

- Based Toxicity Data.

Size, g Avian Consumers of Fruits/Pods/Seeds Avian Consumers of Arthropods

EEC

, mg/kg

- bw RQ Allowable

Fraction Feet to

Fraction

HB/FD

LB/CD 1 EEC

,

mg/kg

bw RQ Allowable

Fraction Feet to

fraction

HB/FD

LB/CD 1

20 59. 8 0.45 22% 13

3 37 5 2.84 3.5% 72

10

100 34.1 0.20

-- -- 21 4 1.27 7.9% 33

7
Distance Needed to Reduce the Presumption of Risk to Below the LOC (1) for Feeding Groups with LOC Exceedances Using Chronic Avian Dietary

- Based Toxicity Data.

All Size Classes 52.5 0.21

-- -- 329 1.29 78% 3

3 Size class not used for dietary risk quotients

1 HB/FD = High Boom/Fine Droplets ; LB/CD = . Low Boom/Coarse Droplets.

Distance Needed to Reduce the Presumption of Risk to Below the LOC (0.1) for Listed Species For Feeding Groups with LOC Exceedances Using Acute Mammalian Dose

- Based Toxicity Data.

Size Class (grams) EECs and RQs

Consumers of Arthropods

EEC RQ Allowable Fraction Feet to Fraction

HB/FD

LB/CD 1

15 314 0.21 48% 7

3

35 217 0.18 56% 7

3

1 HB/FD = High Boom/Fine Droplets; LB/CD = .Low Boom/Coarse Droplets.



### Terrestrial Invertebrates:

HB/FD:

LB/CD:-Page 96 of 117-

Buffer Needed to Reduce the Presumption of Risk to Below the LOC (0. 05 ) for Listed Terrestrial

Invertebrates.

Taxon and Type of Toxicity Data

Used as Basis Concentration

Estimate to

Remove Presumption of

Risk for Listed Species, as defined by the Endpoint*LOC Edge of Field

EEC, mg/cm 2

HB/FD

LB/CD 1 Estimate d RQ 1 Allowable Fraction Buffer Needed,

Feet to Fraction

HB/FD

LB/CD

Honeybee 0.139 mg/cm 2 *0.05

= 0.00695 mg/ c m 2 0.0414

0.0395 0.298

0.284 17%

18% 16

3 RQ estimate is EEC/Endpoint, in this case, edge- of -field EEC ÷ honeybee LC 50 expressed as mg/cm 2 of honeybee surface (see table above for calculations)

. . Allowable fraction is fraction of EEC to achieve concentration below listed spp. LOC (0.05). Bolded and shaded mean exceed Agency listed species LOC (0.05).-Page 97 of 117-



## Appendix C. T-REX and Terrplant Output for Fluensulfone. 

# TREX MODEL INPUTS Assumed broadcast and 85% incorporation These values will be used in the calculation of exposure estimates for foliar, granular, liquid and/or seed applications of pesticides.



### Chemical Identity and Application Information

Chemical Name: Fluensulfone

Seed Treatment? (Check if yes) FALSE

Use: Transplanted Crops

- Groups 8 and 9

Product name and form: 480EC (40% but all calcs in a.i.)

% A.I. (leading zero must be entered

for formulations <1% a.i.): 100.00%

Application Rate (lb ai/acre) 

### 3.5

Half

- life (days): 

### 35

Application Interval (days):

Number of Applications: 

### 1

Are you assessing applications with

variable rates or intervals? 

### no

Summary of Risk Quotient Calculations Based on Upper Bound Kenaga EECs

Table X. Upper Bound Kenaga, Acute Avian Dose

- Based Risk Quotients

Size Class (grams) Adjusted

LD50 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

20 131.88 956.68 7.25 438.48 3.32 538.13 4.08 59.79 0.45 374.70 2.84 13.29 0.10

100 167.89 545.54 3.25 250.04 1.49 306.86 1.83 34.10 0.20 213.67 1.27 7.58 0.05

1000 237.16 244.24 1.03 111.95 0.47 137.39 0.58 15.27 0.06 95.66 0.40 3.39 0.01

Table X. Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients

LC50 EECs and RQs-Page 98 of 117- Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

576 0 840.00 0.15 385.00 0.07 472.50 0.08 52.50 0.01 329.00 0.06

Size class not used for dietary risk quotients

Table X. Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients

NOAEC (ppm) EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

255 8 40.00 3.29 385.00 1.51 472.50 1.85 52.50 0.21 329.00 1.29

Size class not used for dietary risk quotients

Table X. Upper Bound Kenaga, Acute Mammalian Dose

- Based Risk Quotients

Size Class (grams) Adjusted

LD50 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 1474.74 800.88 0.54 367.07 0.25 450.49 0.31 50.05 0.03 313.676 0.2127 11.123 0.0075

35 1193.23 553.51 0.46 253.69 0.21 311.35 0.26 34.59 0.03 216.792 0.1817 7.6877 0.0064

1000 516.11 128.33 0.25 58.82 0.11 72.19 0.14 8.02 0.02 50.2641 0.0974 1.7824 0.0035

Table X. Upper Bound Kenaga, Acute Mammalian Dietary Based Risk Quotients

LC50 (ppm) EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

0 8 40.00 #DIV/0! 385.00 #DIV/0! 472.50 #DIV/0! 52.50 ##### 329.00 #DIV/0!

Size class not used for dietary risk quotients-Page 99 of 117- Table X. Upper Bound Kenaga, Chronic Mammalian Dietary Based Risk Quotients

NOAEC (ppm) EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds/Large

Insects Arthropods

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

250 8 40.00 3.36 385.00 1.54 472.50 1.89 52.50 0.21 329.00 1.32

Size class not used for dietary risk quotients

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 40.22 800.88 19.91 367.07 9.13 450.49 11.20 50.05 1.24 313.68 7.80 11.12 0.28

35 32.54 553.51 17.01 253.69 7.80 311.35 9.57 34.59 1.06 216.79 6.66 7.69 0.24

1000 14.08 128.33 9.12 58.82 4.18 72.19 5.13 8.02 0.57 50.26 3.57 1.78 0.13-Page 100 of 117-



## Appendix D. Earthworm Fugacity Model

Terrestrial Chronic Exposure Estimates for Birds and Mammals Exposed to Incorporated

or Drip Irrigated Applications of Fluensulfone

Terres trial Acute Exposure Estimates for Earthworms Exposed to Incorporated or Drip Irrigated Applications of Fluensulfone

Fluensulfone exposure to terrestrial wildlife from non-granular applications wa s evaluated by estimating pesticide residues on food items that enter the treatment area, including insects and seeds. For the purposes of this assessment, terrestrial wildlife is assumed to include birds, which are also used as a surrogate for reptiles and terrestrial-phase amphibians, and mammals. Since

exposur e to fluensulfone through these types of applications is likely to be limited since it is either incorporated or drip-irrigated (assuming no aerial application and immediate incorporation, e.g., within 24 hours) terrestrial EECs and acute risks were also derived based on an estimation of loadings of pesticide per unit area (ft 2 

### ) for a more refined assessment. The following chronic exposure estimation and risk characterization for terrestrial wildlife considers the exposure route of direct ingestion of soil invertebrates that have ingested granules of soil. In

addi tion, acute risks to terrestrial invertebrates exposed to applications of fluensulfone are estimated using the concentration of fluensulfone in earthworms and earthworm toxicity data, which is used as a surrogate for terrestrial invertebrates and their consumption by the terrestrial

ver tebrates.

Direct Ingestion of Soil Invertebrates

An estimation of fluensulfone concentrations potentially accumulated in the tissues of earthworms was calculated using a fugacity-based (equilibrium partitioning) approach based on the work of Trapp and McFarlane (1995) and Mackay and Paterson (1981). Earthworms dwelling within the soil are exposed to contaminants in both soil pore water and via the ingestion of soil (Belfroid et al . 1994). The concentration of fluensulfone in earthworms was calculated as a combination of uptake from soil pore water and gastrointestinal absorption from ingested soil:

C earthworm 

### = [(C soil 

### )(Z earthworm 

### /Z soil 

### ]+[(C soil water 

### )(Z earthworm 

### /Z water 

### )]

where: C soil 

### is the concentration of chemical in bulk soil (note: a chemical concentration averaged over a 1-15 cm soil depth was used to reflect a concentration across the earthworm occupied area of soil, MRID

48574832 , using the California soil type concentration of 2.118 mg/kg soil, because it had the greatest concentration of the four soils tested.)

Z earthworm 

### is the fugacity capacity of chemical in earthworms = (lipid)(K

ow 

### )(ρ earthworm 

### )/H

Z soil 

### is the fugacity capacity of chemical in soil = (K d 

### )(ρ soil 

### )/H

Z water 

### is the fugacity capacity of chemical in water = 1/H

C soil water 

### is the concentration of chemical in soil water = C soil 

### /K bw 

### K

bw 

### is the bulk soil

- to -water partitioning coefficient = (ρ soil 

### )(K d 

### )+θ+(ε-θ)(K

aw 

### )-Page 101 of 117- 

### K
aw 

### is the air- to -water partitioning coefficient = H/RT H = Henry’s Constant specific to fluensulfone (1.65E-7) R = universal gas constant, 8.31 Joules-m 3 

### /mole- o 

### K T = temperature o 

### K, assumed to be 298 o 

### K

K d 

### = soil partitioning coefficient for fluensulfone (mean value of 1.93, used in PRZM/EXAMS calculations, MRID 48574833)

ρ soil 

### = bulk density of soil, assumed to be 1.3 g/cm 3



### θ = volumetric fraction of the soil, assumed to be 0.30 ε = volumetric total porosity of the soil, assumed to be 0.50 lipid = fraction of lipid in organism 0.01 (Cobb et al . 1995)

K
ow 

### = the octonal to water partitioning coefficient for fluensulfone (91.2, MRID 48574717)

ρ earthworm 

### = the density of the organism, assumed to be 1 g/cm 3



### Table E-1 summarizes the estimated immediate post-treatment soil concentrations of

fluensul fone, assuming 1 cm averaging depth, a soil density of 1.3 g/cm 3 

### , and the granular application rate of fluensulfone (3.5 lb a.i./acre, nematode treatment to Crop Groups 8 and 9).

Table G

- 1 Estimated Soil Concentration for Fluensulfone (Immediately Post

treament)

Application Rate (lb a.i./acre) Soil Concentration (mg/kg

- soil) at 1

- 15 cm depth

3.5 2.118



### Table G-2 summarizes the model inputs and exposure estimates ( i.e., earthworm concentrations in ppm) for insectivorous birds (used as a surrogate for reptiles terrestrial-phase amphibians thatconsume invertebrates) and mammals based on the fluensulfone application incorporated or dripir rigated (3.5 lb a.i./acre).

Table G

- 2 Model Input Parameters and Dietary Exposure Estimates for Avian and Mammalian Receptors (for Soil Concentrations Immediately Post

- treatment)

Parameter Application Rate: 3.5 lb a.i./acre

C soil (mg/kg @ 1

- 15 cm depth) 2.118

C earthworm (mg/kg) 1.46

K d (L/kg) 1.93

Z water (1/H or moles/Pa

- m 3 ) 6.06E+06

Z soil ((K d )(ρ soil )/H) 1.52E+07

Z earthworm ((lipid)(K

ow )(ρ earthworm )/H) 5.53E+06

ρ soil (g/cm 3 ) 1.3

ρ earthworm (g/cm 3 ) 1
θ (unitless) 0.3
ε (unitless) 0.5

K

aw (H/RT) 5.92E

- 06

K bw ((ρ soil )(K d )+θ+(ε

- θ)(K

aw )) 2.804-Page 102 of 117-



### Risk Characterization for Terrestrial Wildlife

Chronic risks for birds and mammals that consume terrestrial invertebrates as the majority of their diet were estimated based on comparison of the concentration of fluensulfone in earthworm tissue (C earthworm 

### ) with chronic toxicity values for birds and mammals. Although earthworms are likely to be present in the top six inches of soil, a 1-15 cm soil depth was used because

fluensul fone is incorporated or drip-irrigated into the soil and soil concentration estimation is immediately post-treatment. It is important to note that this estimation of risk assumes that 100% of the diet is comprised of terrestrial soil invertebrates. In addition, the model assumes that no

metabolism or elimination of the chemical has occurred.

Direct Effects: Insectivorous Mammals, Birds, Reptiles or Terrestrial-Phase Amphibians

Chronic risks for insectivorous mammals were estimated by comparing the C earthworm 

### in ppm to the mammalian chronic NOAEC for fluensulfone (250 mg/kg-diet , based on growth effects, food consumption and histopathology, 48574769). Estimated earthworm residues for insectivorous mammalian receptors (1.46 mg/kg) are less than the mammalian chronic endpoint for

fluensul fone applications at the rate of 3.5 lb a.i./acre. Therefore, the chronic RQ value (<0.01 ) mammals associated with ingestion of terrestrial invertebrates ( i.e., earthworms) that have

bioaccumulated fluensulfone do es not exceed the chronic LOC.

Chronic risks for insectivorous birds (also surrogate for reptiles and terrestrial-phase amphibians) were estimated by comparing the C earthworm 

### in ppm to the avian chronic NOAEC for fluensulfone (255 mg/kg-diet, based on mallard growth effects, 48574846). Estimated earthworm residues for

inse ctivorous avian receptors (1.46 mg/kg) are less than the avian chronic endpoint for

fluensul fone applications at the rate of 3.5 lb a.i./acre. Therefore, the chronic RQ value (<0.01 )

birds associated with ingestion of terrestrial invertebrates ( i.e., earthworms) that have

bioaccumulated fluensulfone do es not exceed the chronic LOC.

However, it is unclear whether other routes of fluensulfone exposure ( i.e., direct consumption of fluensulfone, ingestion of fluensulfone that adheres to soil invertebrates, partitioning of dissolved fluensulfone to on-site sources of wildlife drinking water, and dermal exposure to soil and on

site puddles) or combined routes of exposure would result in chronic risk concerns for mammals, birds, reptiles and terrestrial-phase amphibians.

Indirect Effects: Consumption of Insectivorous Mammals, Birds, Reptiles or Terrestrial-Phase Amphibians

Chronic risks for insectivorous animals were estimated by considering both dietary-based and dose-based exposures and effects. In the dietary method, risks were estimated by comparing the

C earthworm 

### to the mammalian and avian chronic NOAEC for fluensulfone ( 25 0 and 25 5 ppm, respectively, MRIDs 48574 769 and 48574 846 ). In the dose-based method, the residue concentration in earthworms was converted to a daily oral dose based on the fraction of body weight consumed as estimated through mammalian and avian allometric relationships. The dose-Page 103 of 117-



### was then compared to the NOAEL (for rats, 16.2 mg/kg-bw/day, based on male rat weight,

MRID 48574769 , for mallards, 31.2 mg/kg-bw/day, based on male bird weight, MRID 48574846) for bird and mammalian receptors.

Based on the dietary method and the fluensulfone granular application rate of 3.5 lb a.i./acre, the chronic RQ value (<0.01) does not exceed the chronic LOC for insectivorous mammals because the earthworm residue concentration (1.46 mg/kg) is less than the NOAECs (250 and 255 mg a.i./kg-diet, mammal and bird). The earthworm residue concentration, derived based on the dose

m ethod, is first converted to a daily dose by multiplying the dietary C earthworm 

### by the percentage body weight consumed, e.g. for the small mammals (15 g), this is 95% body weight (this is also used as a default value for small birds). In addition, the NOAEL value (16.2 and 32.2 mg/kgbw/day, mammal and bird, respectively) is adjusted to account for the size of the mammals according to the following equation:

Adjusted NOAEL = NOAEL (TW/AW) (0.25)



### where:

TW = body weight of tested animal (350 g rat); and AW = body weight of assessed animal (15 g).

As shown in Table G-3 , the estimated chronic dose for insectivorous mammals and birds, based

on the 3.5 lb a.i./acre application rate and adjusted NOAELs for small mammals and birds does

not exceed the chronic LOC (1.0) with respective RQ values of 0.04 and 0.02. The results of the assessment indicate that, when growth and reproduction effect risks for mammals and birds are

assessed on the basis of daily ingested dietary dose, the accumulation of fluensulfone in terrestrial invertebrates does not represent, by itself, a biologically significant pathway for

exposur e. Other size classes were not assessed since the smallest size classes come the highest rates of food and this screening showed that the risk was biologically significant.

Table G

- 3 Dose

- based Chronic RQ Values for Insectivorous Mammals and Birds at an Application Rate of 3.5 lb a.i./A.

Taxon Body Weight (g) Dose

- adjusted EEC

w (mg/kg) a Adjusted NOAEL

(mg/kg

- bw/day) b Chronic RQ c

Mammals 15 1.39 35.6 0.039

Birds 20 1.39 85.9 0.016

a Dose

- adjusted EEC

w = Dietary EEC

w (ppm) * (%BW consumed/100).

b Adjusted NOAEL = NOAEL(TW/AW) 0.25 ; weight of rats used in calculations was a FDA standard 350g, for mallards, weight data was derived from the study

.

c Chronic RQ = Dose

- adjusted EEC

w /Adjusted NOAEL.

Bolded and Shaded if e xceeds chronic risk level of concern (RQ ≥ 1.0) ; no exceedences were found

.



### Indirect Effects: Earthworms

Acute risks for earthworms (used as a surrogate for terrestrial invertebrates for quantifying risk) exposed to incorporated and drip-irrigation applications of fluensulfone (also serving as food for-Page 104 of 117-



### some mammals, birds, reptiles and terrestrial-phase amphibians) were estimated based on comparison of the concentration of fluensulfone in earthworm tissue (C earthworm 

### ) with the LC 50 

### for earthworms. The estimated earthworm residue (1.46 mg/kg) divided by the LC 50 

### = 148 mg a.i./kg-dry soil results in an acute RQ value of <0.01, which does not exceed the acute LOC ( Table G- 4)

.

Table G

- 4 Acute RQ Estimation for Terrestrial Invertebrates

Application Rate C earthworm (mg/kg @ 1

- 15 cm depth) LC 50 1
(mg a.i./kg

- dry soil) Acute RQ

3.5 lb a.i./acre 1.46 148 <0.01

1 Estimation based on earthworm 14

- d LC 50 (MRID 48574880 ).

* Does not exceed acute LOC (RQ ≥ 0.05).



### Uncertainties

There are a number of uncertainties associated with the fugacity model used to estimate fluensulfone concentrations in earthworm tissue and subsequent risks to insectivorous terrestrial wildlife. It may be possible to further refine this assessment with additional information that

addr esses the following uncertainties:

The fugacity-based model assumes equilibrium partitioning between bulk soil and soil pore water. In addition, the model assumes a fixed value for soil density, earthworm density, temperature, pore space, organic carbon, and the lipid content of the earthworm. Resulting concentrations of fluensulfone in earthworm tissue may be either underestimated or overestimated depending on the soil type, temperature, and size/lipid content of the earthworm at the time of exposure. This assessment considers only one route of exposure ( i.e., ingestion of terrestrial invertebrates that have bioaccumulated fluensulfone from granules in the soil) for insectivorous birds and mammals. In addition, it is assumed that 100% of the diet is comprised of terrestrial soil invertebrates. Given species-specific feeding habits and dietary requirements, this assumption may overestimate risk associated with ingestion of soil invertebrates that have accumulated fluensulfone. Other potential routes of exposure including direct ingestion of fluensulfone, ingestion of fluensulfone adhering to soil invertebrates, partitioning of dissolved fluensulfone to sources of wildlife drinking water, and dermal exposure of granules released to surrounding soil and puddles or combined routes of exposure were not considered.

References

Belfroid, A., M. Sikkenk, W. Seinen, K.V. Gestel, J. Hermens. 1994. The toxicokinetic behavior of chlorobenzenes in earthworm ( Eisenia andrei ) experiments in soil. Environ. Toxicol. Chem.

13:93-99.

Mackay, D. and S. Paterson. 1981. Calculating fugacity. Environ. Sci. Technol. 15: 1006-1014.

Trapp, S. and J.C. McFar lane (eds.). 1995. Plant Contamination Modeling and Simulation of Organic Chemical Processes. Lewis Publishers. Boca Raton, Florida.-Page 105 of 117-



## Appendix E. TerrPlant Output

Table 1. Chemical Identity.

Chemical Name Fluensulfone 1

PC code 50410

Use Nematode Treatment Trans Crops Groups 8 and 9
Application Method Broadcast and Incorp
Application Form Spray Solubility in Water (ppm) 545

Table 2. Input parameters used to derive EECs.

Input Parameter Symbol Value Units

Application Rate A 3.5 y Incorporation I 6 none
Runoff Fraction R 0.05 none

Drift Fraction D 0.01 none

Table 3. EECs for Fluensulfone. Units in y.

Description Equation EEC

Runoff to dry areas (A/I)*R 0.029166667

Runoff to semi

- aquatic areas (A/I)*R*10 0.291666667 Spray drift A*D 0.035 Total for dry areas ((A/I)*R)+(A*D) 0.064166667

Total for semi

- aquatic areas ((A/I)*R*10)+(A*D) 0.326666667

Table 4. Plant survival and growth data used for RQ derivation. Units are in y.

Seedling Emergence Vegetative Vigor
Plant type EC 25 NOAEC EC 25 NOAEC

Monocot 2.5 1.21 >3.49 1 0.0415

Dicot >3.77 1 0.141 1.31 0.419

1 Non

- Definitive Endpoint

- Used.as lower

- bound of risk estimate.

Table 5. RQ values for plants in dry and semi

- aquatic areas exposed to Fluensulfone through runoff and/or spray drift.*

Plant Type Listed Status Dry Semi

- Aquatic Spray Drift

Monocot non

- listed <0.1 0.13 <0.1

Monocot listed <0.1 0.27 <0.1

Dicot non

- listed <0.1 <0.1 <0.1

Dicot listed 0.46 2.32 <0.1
Assume exposure based on both parent + MS; if run based on MS solubility, results are the same. Therefore, EECs represent both fractions. *If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.-Page 106 of 117-



## Appendix F. Fluensulfone Degradate Toxicity Summary.

Comparative Ecotoxicity of Transformation Products

No ecotoxicity concerns were found for the major transformation products: TSA, MS, BSA, deschloro-fluensulfone, butene sulfinic acid and deschloro thiazole sulfonic acid. Studies are

avai lable for TSA, MS and BSA regarding toxicity to aquatic animals and plants and for d es

chl oro-fluensulfone toxicity to aquatic plants. Tables E-1 to E-3 display available aquatic ecotoxicity study data and QSAR estimates for transformation products compared to the parent compound.

Table F-1. Available Aquatic Invertebrate Transformation-Product Toxicity Data Compared w ith Parent.

Test

Substance Acute Endpoint, 96

- h LC/EC 50 (95% C.I.), mg/L 1 Chronic Endpoint, NOAEC or EC 05 , mg/L 1

Available Acute Laboratory Stud y

Data QSAR (EPIWEB 4.1) Estimate [Based on Neutral Organics and Neutral Organic

Acid ] 2 Available Chronic

Laboratory Study

Data QSAR (EPIWEB 4.1)

Estimate

– Chronic

Value Daphnid ( Daphnia

magna ) Mysid

( Americamysis

bahia )

Parent

Technical

Grade Active Ingredient 22 ( 15

- 2 5)

[MRID 48574864] 1.0 (0.46

- 1.9)

[MRID 48574864] Daphnid

- 118 Mysid

- 197* Daphnid : 0.20 (dry wt. and offspring/repro. day ) [MRID 48574856 ] Mysid : 0.37 (male length) [MRID 4857485 7 ] Daphnid

- 13.8 Mysid

- 16.7

TSA

-- 3 >123 (NA) [MRID 48574869] Daphnid

- 6.46e+005

Mysid

- 2.37e+007* -- Daphnid

- 42 900 Mysid

- 5.81e+006*

MS

-- 19 (16

- 22) [MRID 48574877] Daphnid

- 2490 Mysid

- 206 00 -- Daphnid

- 217 Mysid

- 303 0

BSA

-- >114 (NA) [MRID 48574873] Daphnid

- 2.38e+005

Mysid

- 5.66e+006* -- Daphnid

- 171 00 Mysid

- 1.2e+006*

Deschloro

Fluensulfone -- -- Daphnid

- 836 Mysid

– 372 0 * -- Daphnid

- 82 Mysid

- 442

Butene

Sulfinic Acid -- -- Daphnid

- 219 00 Mysid

– 5.21e+005* -- Daphnid

- 15 80 Mysid

- 1.1e+005

Deschloro

Thiazole

Sulfonic Acid -- -- Daphnid

1.79e+006* Mysid

- 1.14e+008* -- Daphnid

- 1.07e+005 Mysid

- 3.4e+007*

TSA - thiazole sulfonic acid; MS - methyl sulfone; BSA - butene sulfonic acid.

1 Parent results are in mg a.i./L; TSA results are in mg TSA/L; MS results are in mg MS/L; and BSA results are in mg BSA/L.

2 For deschloro-fluensulfone, since Ecosar does not assess charged particles, used smiles O=S(=O)(CCC(F)=C(F)F)c1nccs1

3

-- No Data; NA – information not available; * = asterisk designates: Chemical may not be soluble enough to measure this effect.-Page 107 of 117-



### Table F-2. Available Fish Transformation-Product Toxicity Data Compared with Parent.

Test Substance Acute Endpoint, 96

- h LC/EC 50 (95% C.I.), mg/L 1 Chronic Endpoint, NOAEC or EC 05 , mg/L 1

Available Acute Laboratory

Stud y Data QSAR (EPIWEB 4.1) Estimate [Based on Neutral Organics and Neutral Organic

Acid] 2 Available Chronic

Laboratory Study

Data QSAR (EPIWEB

4.1) Estimate

– Chronic Value Bluegill ( Lepomis

macrochirus ) Sheepshea

d Minnow ( Cyprinodo

n variegatus )

Parent Technical

Grade Active Ingredient

MCW2 Technical 11.6 ( 9.0

- 15.4 )

[MRID 48574853] 28 ( 20

- 38 ) [MRID

48574852 ] FW

– 20 7 *

SW

– 286* Fathead Minnow

( Pimephales promelas )

0.63 (post

- hatch survival and signs of toxicity) FW

- 21. 7

SW

- 31. 3

TSA >121 (NA)

[MRID 48574866] -- 3 FW

– 1.93e+006 *

SW

– 3.5e+006 * -- F W

- 1.59e+005

SW

- 371 00

MS 35 ( 28

- 44 )

[MRID 48574874] -- FW

– 57 60

SW

– 917 0 -- F W

- 53 2

SW

- 299

BSA >122 (NA)

[MRID 4 8574870] -- FW

– 6.6e+005 *

SW

– 1.15e+006 * -- F W

- 562 00

SW

- 16 700

Deschloro

Fluensulfone -- -- FW

– 17 40

SW

– 262 0 -- F W

- 169

SW

- 13 7

Butene Sulfinic

Acid -- -- FW

– 607 00

SW

– 1.06e+005 -- F W

– 51 7

SW

- 1560

Deschloro

Thiazole Sulfonic

Acid -- -- FW

– 5.88e+006 *

SW

– 1.12e+007 * -- F W

- 4.64e+005

SW

- 782 00

TSA - thiazole sulfonic acid; MS - methyl sulfone; BSA - butene sulfonic acid.

1 Parent results are in mg a.i./L; TSA results are in mg TSA/L; MS results are in mg MS/L; and BSA results are in mg BSA/L.

2 For deschloro-fluensulfone, since Ecosar does not assess charged particles, used smiles O=S(=O)(CCC(F)=C(F)F)c1nccs1

3

-- No Data; NA – information not available; * = asterisk designates: Chemical may not be soluble enough to measure this effect.

Table F-3. Available Aquatic Plant Transformation-Product Toxicity Data Compared with Parent Using the Green Alga (

Pseudokirchneriella subcapitata)

.

Test Substance EC 50 (95% C.I.),

lb a.i./A 1 ,2

[ R eference] EC 05 (95% C.I.) and NOAEC, mg a.i./L 1,3

[ R eference] QSAR (EPIWEB 4.1) Estimate [Based on Neutral Organics and Neutral Organic

Acid] 4

Parent Technical Grade Active Ingredient

MCW2 Technical 0.022 ( 0.020

- 0.024 ) [MRID 48574858] Cell Density : EC 05 : 0.011 ( 0.0068

- 0.0 17)

NOAEC: 0.00 89 [MRID 48575017] 96

- hr EC50 57.5

ChV 22.2

TSA >4.4 (NA) 5
[MRID 48574868] Growth Rate (Yield) : EC 05 : 0.090 (NA)

NOAEC: 4.4 [MRID 48574868] 96

- hr EC50 664 00

ChV 141 00

MS 2.5 ( 1.7

- 3.7 ) [MRID 48574876] Cell Density : EC 05 : 1.1 (0 .47

- 2.6 )

NOAEC: 1.3 [MRID 48574876] 96

- hr EC50 543

ChV 15 4

BSA >4.4 (NA) [MRID 48574872] Cell Density, Growth Rate and Yield : EC 05 : >4.4 (NA), NOAEC: 4.4 [MRID 48574872] 96

- hr EC50 305 00

C hV 70 60

Deschloro

- Fluensulfone >4.5 ( NA ) [MRID 48574878] Cell Density, Growth Rate and Yield : EC 05 : 0.036 ( 3.7x10

- 4

- 3.5 )

NOAEC: 0.43 [MRID 48574878] 96

- hr EC50 249

ChV 79.7-Page 108 of 117-

Butene Sulfinic Acid

-- -- 96

- hr EC50 28 10

C hV 648

Deschloro Thiazole

Sulfonic Acid -- -- 96

- hr EC50

1.39e+005

ChV 2660 0 TSA - thiazole sulfonic acid; MS - methyl sulfone; BSA - butene sulfonic acid.

1 Parent results are in lb a.i./A; TSA results are in lb TSA/A; MS results are in lb MS/A; BSA results are in lb BSA/A; and

Deschloro-fluensulfone results are in lb Deschloro-fluensulfone/A.

2 For plants this is the endpoint of fifty percent effect used to assess risk to non-listed species.

3 For plants this is the no-observed effect endpoint or five percent effect endpoint used to assess risk to listed species.

4 For deschloro-fluensulfone, since Ecosar does not assess charged particles, used smiles O=S(=O)(CCC(F)=C(F)F)c1nccs1

5

-- No Data; NA – information not available; ChV = Chronic Value – QSAR chronic endpoint estimate.



### Laboratory studies showed that for aquatic invertebrates, all transformation products were greater than two orders of magnitude less acutely toxic to mysids than the parent compound ( Table F-1 ). The 96-h LC 50 

### ranged from 19 to >123 mg/L for transformation products compared to 1.0 mg a.i./L for the parent compound. For freshwater fish, all transformation products were less acutely toxic by at least half to the bluegill than the parent compound ( Tab le F-2 ). The 96-h

LC 50 

### ranged from 35 to >122 mg/L for transformation products compared to 12 mg a.i./L for the parent compound. For aquatic plants, all transformation products were greater than two orders of magnitude less acutely toxic to green algae than the parent compound ( Table F-3 ). The EC 50 

### ranged from 2.5 to 13 mg/L for transformation products compared to 0.022 mg a.i./L for the parent compound.

Toxicity estimates using EPISuite 4.1 were also run to fill data gaps for transformation products that did not have available toxicity data ( Tables F-1 to F-3 ). These estimates showed all transformation products to be less toxic than parent. However, a comparison of available toxicity data with the estimates showed that EPISuite was not populated with sufficient data on compounds similar to these to be a good predictor of toxicity for these compounds – making these estimates unreliable. Most estimates were one to two orders of magnitude (or more) less sensitive than measured endpoints. Uncertainty exists for the ecological impact of the transformation products without toxicity data. This analysis did not suggest that any of the major degradates were likely to be more toxic than the parent compound, but did not offer any quantifiable certainty that they are not.

Aquatic Organisms Toxicity Comparisons of Fluensulfone TGAI and its Metabolites

Acute a quatic toxicity data (fish, aquatic invertebrates, and algal studies) are available for three degradates of fluensulfone and algal data only available for a fourth.

Table F.4 . Comparison of Degradate and Parent Compound Toxicity*

Test Material Test Species LC/EC 50 Toxicity Value (mg/L) Molecular

weight (g/mol) Degradate toxicity

(mg/L) expressed in terms of the parent compound 1

Fluensulfone Parent

5

- Chloro

- 2

- [3,4,4

- trifluor

- 3

- butene

- 1

- yl)sulfonyl]

- thiazole Mysid ( Americamysis

bahia ) 1.0 [MRID 48574864]

291.7 

### --
Bluegill ( Lepomis

macrochirus ) 11.6 [MRID 48574853] 

### -- Green algae ( Pseudokirchneriella 0.022 [MRID 48574858] 

### ---Page 109 of 117-

Test Material Test Species LC/EC 50 Toxicity Value (mg/L) Molecular

weight (g/mol) Degradate toxicity

(mg/L) expressed in terms of the parent compound 1
subcapitata)

TSA ( Thiazole Sulfonic Acid)

5

- chloro

- thiazole

- 2

- sulfonic

acid Mysid ( A. bahia ) >123

[MRID 48574869]

199.5 >180

Bluegill ( L.

macrochirus ) >121 [MRID 48574866] >177

Green algae ( P. subcapitata) >4.4 [MRID 48574868] >6.43

MS ( Methyl Sulfone)

5

- chloro

- 2

- methyl sulfonyl

thiazole Mysid ( A. bahia ) 19

[MRID 48574877

197.7 28.0

Bluegill ( L.

macrochirus ) 35 [MRID 48574874] 51.6

Green algae ( P. subcapitata) 2.5 [MRID 48574876] 3.69

BSA ( Butene Sulfonic Acid) 3,4,4

- trifluoro

- but

- 3

- ene

- 1

- sulfonic acid Mysid ( A. bahia ) >114

[MRID 48574873]

190 >175

Bluegill ( L.

macrochirus ) >122 [MRID 4 8574870] >187

Green algae ( P. subcapitata) >4.4 [MRID 48574872] >6.76

Deschloro

- Fluensulfone

2

- (3,4,4

- trifluoro

- 3

- buteny sulfonyl) thiazole Green algae ( P. subcapitata) >4.5 [MRID 48574878] 257 >5.11

1 [(MW parent/MW degradate) * (toxicity endpoint degradate (mg/L))] = LC/EC 50 of degradate as parent, mg a.i./L.

* Bold values indicates potentially equal degradate toxicity when compared to the parent, fluensulfone TGAI

.



### Degradates were less toxic than parent, with the possible exception of MS, which had somewhat similar toxicity to parent when tested on the mysid and bluegill. Based on toxicity

expr essed as parent (see Table F.4 ), the mysid LC 50 

### was 28 and 1 mg a.i./L for MS and parent, respectively. The bluegill LC 50 

### was 52 and 12 mg a.i./L, for MS and parent, respectively. The only a vailable plant data was with green algae and this showed MS to be about 2 orders of magnitude less toxic than parent (EC 50 

### of 3.7 and 0.022 mg a.i./L for MS and parent, respectively).

Table F.5. Comparison of Toxicity of 480EC Formulation to the Fluensulfone Technical

Acti ve Ingredient.

Taxa (Study) Test Species Test Substance (Flow

through/Static) Endpoint (95% C.I.) ( m g a.i./L, mean

measured) Toxicity

Enhancement

of

Formulation MRID

Freshwater

Fish Acute Rainbow trout ( O.

mykiss ) TGAI Static LC 50 = 38 (27

- 53 ) 11.9x 48574740

480EC Static LC 50 = 3.2 (2.7

- 3.7) 48574927 Bluegill ( L.

macrochirus ) TGAI Static LC 50 = 13 (12

- 15 ) 5.2x 48574853

480EC Static LC 50 = 2.5 (2.1

- 2.9) 48574929-Page 110 of 117-

Estuarine/

Marine

Fish Acute Sheepshead

Minnow ( C. variegatus ) TGAI Static LC 50 = 28 (20

- 38) 4.7x 48574852

480EC Static LC 50 = 5.9 (5.0

- 6.8) 48574928

Daphnid

Acute Waterflea

( D. magna ) TGAI Static EC 50 = 22 (17

- 29) 58x 48574855

480EC Static EC 50 = 0.38 (0.29

- 0.50) 48574930

Avain

Acute Northern

bobwhite quail ( C. virginianus ) TGAI Oral Dose LD 50 = 1510 (1220

- 1880)
1.5x 48574842

480EC Oral Dose LD 50 = 998 (791

- 1260) 48574951

Rat Acute Wistar rat

(R.norvegicus ) TGAI Dietary

Dose LD 50 = 671 mg a.i./kg

- bw

Less Toxic 48574745

480EC Dietary

Dose LD 50 = >947 mg a.i./kg

bw 48574924

Bee

Contact

Acute Honey Bee

( A. mellifera ) TGAI Contact LD 50 0.167 (0.141

- 0.210)

mg a.i./bee

LD 50 >0.200 mg a.i./bee Less Toxic 48574879

480EC Contact 48574934

Earthworm

Acute Earthworm

(E. fetida) TGAI Soil LC 50 = 148 mg a.i./kg soil

dw 2.6x 48574880

480EC Soil LC 50 = 57.4 mg a.i./kg soil

dw 48574939

Algal

Acute Green algae

(P. subcapitata) TGAI Static EC 50 = 0.022 (0.020

- 0.024 )

EC 50 = 0.025 (0.021

- 0.030 ) 1.6x 48574858

48575017

480EC Static EC 50 = 0.015 (0.011

- 0.021 ) 48574931



### The available acute toxicity data for the 480EC formulation, which contains 40% fluensulfone a.i., show that it is approximately 5-12 times more toxic to fish, 58x more toxic to aquatic invertebrates, 2x more toxic to algae, 3x more toxic to earthworms, and 2x more toxic to birds than the fluensulfone a.i. alone,; however, the formulation was less toxic to rats and honeybees than the a.i. alone.-Page 111 of 117-



## Appendix G. Submitted Ecological Effects Studies for Fluensulfone and Remaining Data Gaps.

Fluensulfone Global EPs: Active substance; Emulsifiable Concentrate Formulation 480 EC.

Primary Reviewer: Donna R. Judkins, US EPA

Date: January 10, 2013

Secondary Reviewers: (PMRA and APVMA) Derek Francois, PMRA

Date: March 20, 2013 Jack Holland, APVMA

Date: June 10, 2013

Please Note: The study reviews were written in both US EPA DER (Data Evaluation Report) and standard global monograph formats. The US EPA contractor initially used the DER format to write the study reviews and due to time constraints, US EPA and PMRA decided to use those reviews rather than taking the time to re-write them. Later, however, APVMA joined the review and used the monograph format for their review. All major comments were addressed and reviewers agreed that either format was useable depending on the preference, rather than spend time merging the documents. No reporting table was constructed because no major issues came

about

-- PMRA stated that no reporting table would be needed since there were no issues of

contention between US EPA and PMRA in t he DE Rs 7 

### and APVMA suggested that given the lack of major issues, they proceed with the summaries from the monograph and the US EPA/PMRA proceed with the DERs. 8



### Beneficials Fluensulfone Global EPs: Active substance; Emulsifiable Concentrate Formulation

480 EC.

P rimary Reviewer: Derek François, PMRA, Canada

Date: April 30

, 201 2

Secondary Reviewers : (APVMA, PMRA, and US EPA) Donna R. Judkins, US EPA

Date: August 13, 201 3

7 Per February 21, 2013 email note from Derek Francois to Donna Judkins.

8 Per July 18, 1013 email from Kahli Weir (APVMA) to Donna Judkins (US EPA) and Derek Francous (APVMA).-Page 112 of 117-



### Table G.1. Submitted Ecological Effects Studies for Fluensulfone and Identification of

Ad ditional Data Needs (Beige Shading Indicates Formulated Product Toxicity).

OCSPP

Guideline Data

Requirement Submitted

Studies ( MRID ) Study Issues Review Classification Sufficient

for Risk

Assessment? Current

Additional

Data Need

850.1010 Daphnid

Acute Toxicity 48574855 N/A Acceptable Yes No

850.1010 Daphnid

Acute Toxicity with

Formulated

Product 48574930 N/A Acceptable Yes No

850.1035 Mysid Acute

Toxicity
48574864 Negative control had 15% mortality;

however two lowest

treatments had no mortality. Suppmemental Quantitative Yes No

850.1035 Mysid Acute

Toxicity with

Formulated

Product 48574932 N/A Acceptable Yes No

850.1025 Oyster Acute

Toxicity 48574865 N/A Acceptable Yes No

850.1025 Oyster Acute

Toxicity with

Formulated

Product 48574933 N/A Acceptable Yes No

850.1075

Fish Acute

Toxicity 48574740 N/A Acceptable Yes No

850.1075 48574851 N/A Acceptable Yes No

850.1075 48574852 N/A Acceptable Yes No

850.1075 48574853 N/A Acceptable Yes No

850.1075 Fish Acute

Toxicity with

Formulated

Product 48574927 N/A Acceptable Yes No

850.1075 48574928 N/A Acceptable Yes No

850.1075 48574929 N/A Acceptable Yes No

850.1300 Life

- Cycle

Toxicity Daphnid 48574856 – no NOAEC for

repro duction or dry

w eight

. Supplemental Quantitative Yes No

850.1350 Life

- Cycle

Toxicity Mysid 48574857 N/A Acceptable Yes No

850.1400 Fish Early

Life

- Stage Toxicity 48574854 N/A Acceptable Yes No

850.1735 Sediment

Acute Toxicity 48574862 – quantitative for

survival data only. Supplemental Quantitative Yes No

850.4400 Aquatic Plant

Toxicity 48574863 N/A Acceptable Yes No-Page 113 of 117-

OCSPP

Guideline Data

Requirement Submitted

Studies ( MRID ) Study Issues Review Classification Sufficient

for Risk

Assessment? Current

Additional

Data Need

using Lemna

850.5400

Algal

Toxicity 48574858 N/A Acceptable Yes No

850.5400 48575017 N/A Acceptable Yes No

850.5400 48575019 N/A Acceptable Yes No

850.5400 48574859 N/A Acceptable Yes No

850.5400 48574860 N/A Acceptable Yes No

850.5400 48574861 N/A Acceptable Yes No

850.5400 Algal

Toxicity with

Formulated

Product 48574931 N/A Acceptable Yes No

850.2100 Avian Acute

Toxicity 48574842 N/A Acceptable Yes No

850.2100 48574843 Regurgitation

-

r equest ed p asserine

d ietary s tudy Supplemental Qualitative No Yes 1

850.2100 Avian Acute

Toxicity with

Formulated

Product 48574951 N/A Acceptable Yes No

850.2200 Avian Sub

acute Dietary Toxicity 48574844 N/A Acceptable Yes No

850.2200 48574845 N/A Acceptable Yes No

850.2200

Modified Not Assigned Only one day

exposure and five days recovery; need longer exposure for feeding birds. Supplemental Qualitative No Yes

850.2300 Avian

Reproduction 48574847 Small cages. Supplemental Quantitative Yes No

850.2300 48574846 N/A Acceptable Yes No

850.3020

& Non

Guideline
OECD

213 Honeybee

Acute

Contact Toxicity 48574879 N/A Supplemental Quantitative Yes No

850.3020

& Non

Guideline Honeybee

Acute

Contact Toxicity with

Formulated

Product 48574934 N/A Supplemental Quantitative Yes No

Non

Guideline Bumble Bee

Drip Irrigation Study 48574910 N/A Supplemental Quantitative Yes No

850.4100 Terrestrial

Plant 48574944 – no definitive endpoints Supplemental Quantitative No

-

Incomplete No-Page 114 of 117-

OCSPP

Guideline Data

Requirement Submitted

Studies ( MRID ) Study Issues Review Classification Sufficient

for Risk

Assessment? Current

Additional

Data Need

Toxicity (Seedling Emergence) Toxicity with

Formulated

Product

850.4150 Terrestrial

Plant Toxicity (Vegetative Vigor) Toxicity with

Formulated

Product 48574943 – no definitive endpoints for four plants ; r equest ed Tier

II data for radish, soybean, cabbage

and onion Supplemental Quantitative No

-

Incomplete No

850.4225 Tier II

Seedling Emergence 48574945 N/A Acceptable Yes No

850.4150 Tier II

Vegetative Vigor 48574972 Did not get a definitive endpoint for all plants, but did

for the most sensitive; no further

data needed. Supplemental Quantitative Yes No

NA None;

Beneficial

Insects

- Effects on the Parasitic Wasp

with

Formulated

Product 48574936 N/A Supplemental (non

guideline studies) Yes No

NA None;

Beneficial

Insects

- Effects on the Predatory Mite

with

Formulated

Product 48574937 N/A Supplemental (non

guideline studies) Yes No

NA None;

Beneficial

Insects

- Effects on the

Predceous

Mite

with

Formulated

Product 48574935 N/A Supplemental (non

guideline studies) Yes No-Page 115 of 117-

OCSPP

Guideline Data

Requirement Submitted

Studies ( MRID ) Study Issues Review Classification Sufficient

for Risk

Assessment? Current

Additional

Data Need

NA None;

Beneficial

Insects

- Effects on the

Ground

- active

Beetle with

Formulated

Product 48574938 N/A Supplemental (non

guideline studies) Yes No

NA None;

Beneficial

Insects

- Effects on the Springtail with

Formulated

Product 48574941 N/A Supplemental (non

guideline studies) Yes No

NA

OECD

207 None; Acute

Toxicity to

Earthworms

- with TGAI

- with

Formulated

Product 48574880 N/A

Supplemental (non

guideline studies) Yes No

48574939 N/A

NA None;

Subchronic

Earthworm Toxicity with

Formulated

Product 48574940 N/A Supplemental (non

guideline studies) Yes No

1 To assess toxicity to passerine bird species, an acute dietary toxicity study of fluensulfone TGAI was conducted using adult zebra finches ( Taeniopygia guttata ) in a modified study (MRID NEED A NUMBER) designed to reduce complications caused by regurgitation and feed avoidance in the earlier canary oral dosing study (MRID 48574843). Due to the likelihood of avoidance of or aversion to the treated diet, the standard five-day dietary exposure was shortened to 24-h. Study authors cited preliminary method work suggesting that in five–day exposures starvation threshold existed between 1.2 and 2.3 g/day food consumption per bird. Data were not available to confirm the starvation feeding level. By reducing exposure to 24-h in this study, however, even birds that ate less than 1.0 grams had good (90 %) survival. However, the resulting endpoint calculations were deemed not useable for risk assessment without substantiating the starvation level or the trend over more than one day (i.e., birds feeding above the starvation rate on the first day might reduce feed consumption subsequently, thus possibly missing some effects). A significant reduction in feed consumption was measured at 1590 mg a.i./kg-diet; such a reduction is likely to affect growth and reproduction, but the degree of environmental significance was not fully quantifiable. Clinical signs of toxicity were also observed in the two highest treatment groups (5070 and 8890 mg a.i./kg-diet), including ruffled appearance and loss of coordination. Necropsy results showed pale kidneys and liver and enlarged kidneys at the end of the test for birds exposed to treatments of 1590 mg a.i./kg-diet and above. Statistically significant reductions in feed consumption and mean body weight were observed in all except the lowest treatment group, 891 mg ai/kg-diet, during exposure Days 0-1. The results could not be quantifiably extrapolated to a 5-day exposure endpoint and therefore, the results may be used only qualitatively to describe risk.-Page 116 of 117-



### Table G.2. Submitted Ecological Effects Studies for Degradates of Fluensulfone and

Identi fication of Additional Data Needs.

OCSPP

Guideline Data

Requirement Submitted

Studies ( MRID ) Study Issues Review

Classification Sufficient

for Risk

Assessment? Current

Additional

Data Need

850.1035

Mysid Acute

Toxicity 48574869 N/A Acceptable Yes No

850.1035 48574873 N/A Acceptable Yes No

850.1035 48574877 N/A Acceptable Yes No

850.1075

Fish Acute

Toxicity 48574866 N/A Acceptable Yes No

850.1075 48574870 N/A Acceptable Yes No

850.1075 48574874 N/A Acceptable Yes No

850.5400

Algal Toxicity

Test 48574868 EC 50 non

- definitive. Supplemental Quantitative Yes

Partially No, not at

this time.

850.5400 48574872 EC 50 non

- definitive. Supplemental Quantitative Yes

Partially No, not at

this time.

850.5400 48574876 N/A Acceptable Yes No

850.5400 48574878 N/A Supplemental Quantitative Yes

Partially No, not at

this time.

NA

OECD 207 None; Acute

Toxicity to

Earthworms with 48574881 N/A Supplemental (non

- guideline studies) Yes No 48574882 N/A

48574883 N/A

NA None;

Subchronic

Earthworm Toxicity with

Formulated

Product 48574940 N/A Supplemental (non

- guideline studies) Yes No