UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHING T O N D

. C

., 20460

OFFICE OF CHEMICAL SAFETY A N D POLLUTIO N PREVEN TI ON



## PC Code: 129223 Chemical: Sedaxane DP Barcode: 405155; 407045



### March 21, 2013

MEMORANDUM

SUBJECT:

TO:

FROM:

THROUGH: 

### Ecological Risk Assessment for New Seed Treatment Uses of Sedaxane includ i ng Corn, Sorghum, Dried She ll ed Peas and Beans, Chickpeas, Lentils and Fava beans, Rapeseed subgroup and Potato Pieces. PC Code: 129223; DP Barcode: 405155,407045



### Heather Garvie, Reviewer Cynthia Giles-Parker, Chief Herbicide Branch Registration Division (7505P)

Amy Blankinship, Chemist 

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James Hetrick, Ph

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# Senior**L§~ st** **,...:_;~** t/.

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### Rochelle Bohaty, Ph.D., Chemist Environmental Risk Branch III Environmental Fate and Effects Division (7507P)

Dana Spatz, Branch

# Chie~ Rosanna Louie

- Juzwiak, RAPL

. Environmental Risk Branch: Environmental Fate and Effects Divis i on (7507P)

The registrant, Syngenta Crop Protection, Inc. is requesting to revise the Vibrance (EPA Reg. No.100-1374; 45.45% sedaxane) label to add the following proposed seed treatment uses: dried shelled peas and beans; chickpeas; lenti l s and fava beans; sorghum, rapeseed subgroup (including canola), corn, and potato.

I. Executive Summary



### The registrant, Syngenta Crop Protection, Inc. is requesting to revise the Vibrance (EPA Reg

. No

. 1 00-1374; 45.45% sedaxane) label to add the following proposed seed treatment uses: dried she ll ed peas and beans; chickpeas; lentils and fava beans; sorghum, rapeseed subgroup (including canola), corn and potato.

1



# '

### 2 The likelihood of acute and ch ronic risk to freshwater a nd estuarine/marine fish and invertebrates, freshwater amphibians, and aquati c plants from exposure to sedaxane from the proposed uses is anticipated to be low as the calculated RQ values for each taxa did not exceed the level of concern (LOC).

For birds/terrestrial-phase amphibians/reptiles, th ere were no mortalities in any of the available acute and subacute avian studies. No RQs were calculated; however, based on a comparison of the calculated EECs and the highest concentration te sted, acute risk to non- listed and listed birds (surrogates for terrestrial-phase amphibians and rep tiles) and mammals is anticipated to be low. Chronic avian RQs did not exceed the LOC. Fo r mammals, neither the acute or chronic RQs exceeded the LOC.

The terrestrial plant RQs did not exceed the LOC.

II. Analysis

A. Use Characterization

The proposed changes to Vibrance (EPA Reg. No . 100-1374) label is to add uses for seed treatment to dried shelled peas and beans; chickpeas; lentils and fava beans; sorghum, rapeseed subgroup (including canola) and corn. Treatment to potato pieces is also included on the proposed label.

Sedaxane is a pyrazole-carboxamide fungicide within the anilide f ungicide chemical class and is currently registered as a seed tr eatment. Sedaxane was recently re gistered in the United States as a seed treatment for small grain cereals (barle y, wheat, oats, rye and triticale), soybean and canola to protect against certain soil-borne and seed-borne diseas es. Target fungal pathogens for sedaxane include: Fusarium Spp. Pythium spp., Septoria , smut ( Ustilago tritici ), stink bunt ( Tilletia caries ), loose smut ( Ustilago nuda ), head smut ( Sphacelotheca reiliana ) and Rhizoctonia spp. In addition to the technical product, three end use products were registered. Two of the proposed end use products contain a combination of multiple pesticide active ingredients, including difenocon azole, mefenoxam and thiamethoxam. These uses are considered widespread.

According to the proposed label, sedaxane would be applied as a water-based slurry to seeds which are then planted accordi ng to planting practices employed for the respective crops to provide protection against certain seed-born and soil-born diseases. The label does not mention the use of a sticker agent and as such there may be an increased likelihood of creating dust from abraded seed coatings.

The application rates for each of the proposed uses (dried she lled peas and beans; chickpeas; lentils and fava beans; sorghum; rapeseed s ubgroup (including canola); corn; and potato) are provided in Table 1. For potato, th e proposed label is that a singl e application rate resulting in 0.1 lb a.i./A, using the maximum application rate of 0.08 fl oz. product/10 0 seed, can be applied once every other year. To achieve 0.1 lb a.i./A usi ng the labeled application rate to 100 lb seed, a

### 3 maximum seeding rate (lb seed/A) was calcula ted. Based on information provided by the registrant, the optimal size of a potato pi ece is 2.25 oz, with a maximum size of 2.5 oz. 1 

### . If using the calculated seeding rate (3,333 lb seed/A) a nd the optimal size, this equates to 23,701 potato pieces per acre. This should represent a high-end estimate of the number of potential potato pieces in an acre based on inform ation presented by the registrant.

Label considerations

On page ten of the proposed Vibrance TM 

### label (EPA Reg. No. 100-1374) for potato converting the use rate to pounds a.i. per 100 pounds seed (lb a.i./100 lb seed) results in slightly different values when using the two use rate methods proposed on the label. If calculating a “lb a.i./100 lb seed” use rate using the proposed label rate of 0.08 fl oz product/100 lb seed, then the resulting value is 0.0026875 lb a.i./100 lb seed. If the labele d use rate of 2.5 g a.i./100 kg seed is used to convert to pounds, then the valu e is 0.00250 lb a.i./100 lb seed. As the fluid ounce rate resulted in a high application rate, this rate was modeled. This slight difference in values also occurs in the other labeled uses as well which represents th e low end range of the la beled application rate.

1 Letter addressed to Ms. Heather Garvie, OPP, U.S. EPA from John Keeling of the National Potato Council. Dated January 29, 2013.4Table 1. Proposed Sedaxane Application RatesCropMaximumApplication Ratelb a.i./100 lb of seedMaximumSeeding Ratealb seed /AMaximum SingleApplication Ratelb a.i./A(kg a.i./ha)Maximum TotalApplication RateMaximum Numberof Applications MRI (days)
cMinimumPlanting Depthdin Inches (cropprofile state andyear)/ CommentsPer Yearlb a.i./APer CCblb a.i./APer Yearlb a.i./APer CCblb a.i./Acorn 0.04 33e0.013 (0.015)0.026 0.026 2 2 302 (Nebraska 2007;includes Kansas,North Dakota, andSouth Dakota)dried shelledpea and bean(subgroup 6C;except soybean)0.005 42f0.002(0.002) 0.004 0.004 2 2 302 (Colorado2003); 1-3(Kansas 2004);1.5 (Minnesota2001);rapeseed(subgroup 20Aincludingcanola)0.005 5 0.0003(0.0003) 0.006 0.006 2 2 30h1⁄4 (Kentucky2010)sorghum 0.005 9 0.0046(0.0052) 0.0092 0.0092 2 2 302 (Kansas 2000);2 (Oklahoma2009)potato 0.003 3333g0.1 (0.11) 0.1 0.1 1 1 NA3-4 (Florida2008); 2-4(Montana 2002);2-3 (Texas, 2009)a.The maximum seeding rate was developed based on data provided by BEAD—J. Becker; S. Ratnayake.Acres Planted per Day and Seeding Rates of Crops Grownin the United States,March 24, 2011.b.Reported as per crop cycle or per season on label(s).c.MRI – Minimum retreatment intervald.The minimum planting depth was taken from the USDA’s National Information System for the RegionalIPM Centers crop profiles. Brackets indicate which state’scrop profile the value was taken from.e.Sweet corn [59,739 seeds/A; 1,800 seeds/lb]f.Southern pea [139,392 seeds/A; 3,200 seeds/lb]g.Rate determined by calculating the necessary lb seed/A to achievean eventual maximum single application rate of 0.1 lb a.i./Ausing the proposed label maximumapplication rate of 0.003 lb a.i./100seed (0.08 fl oz product/100 lb seed)h.Except canola

### 5 B. Environmental Fate Summary

Environmental transformation of sedaxane follows two pathways (see D405391 and 407956 for more details). Laboratory data indi cate that in the environment seda xane is persistent (Table 2). Sedaxane is only susceptible to degradation via aerobic soil metabolism. Laboratory half-life values for aerobic soil metabolism are 296-400 (s oil) days based on single first order (SFO) kinetics; however, aerobic biodegradation of sedaxane in soil does not fo llow single first order kinetics (SFO). In general, sedaxane con centrations decrease over the first 100 days (approximate); however, after 100 days, sedaxane concentrations remain steady (approximately 50% of the applied radioactiv ity) through study termination ( ≥ 365 days). Additional kinetic analysis using Nth-Order Rate Model or Indeterminate Order Rate Equation ( 

### IORE) and Double First-Order in Parallel (DFOP) models resulted in representati ve half-lives >100 days (often >365 days). 2 

### Sedaxane photolysis studie s (laboratory half-life of 46 days for aqueous photolysis and 253 days for soil photolysis) 3 

### also suggest sedaxane is persistence in the environment. Hydrolysis, anaerobic soil and aquatic transformation, and aer obic aquatic metabolism are not expected to contribute to the di ssipation of sedaxane in the environment. Terrestrial field dissipation data (DT 50 

### value 114-132 days) suggest sedaxane will persist in the environment consistent with laboratory me tabolism and photolysis data.

Trans - and cis - isomers of sedaxane show comparable degradation rates in soil; however, only a few submitted studies distinguish the two isomers. There is one aerobic soil metabolism study that contains both data for sedaxane degradati on after direct soil application, as well as soil dissipation and transformation data following soil incorporation of sedaxane treated seeds. In addition, the registrant submitted several additional aerobic soil dissipation studies that explored the dissipation of sedaxane after planting of treated seeds. While seed treatment studies represent the intended use pattern and permit the identifi cation of potential enviro nmental transformation products, these studies do not pe rmit the calculation of an aer obic soil metabolism rate (or corresponding half-life values), as ot her dissipation mechanisms may occur [ i.e. , plant uptake in roots or shoots (shoots were analyzed in the submitted studies; however, the roots were analyzed as part of the soil matrix), or chemical sorption to seed coat] wh ich cannot be parsed out due to the study design. In addition, a large amount of unextracted residues further complicates the interpretation of the seed st udies. The amount of unextracted residues increases throughout the study. Despite these complications, these aerobic dissipation/degradation studies suggest that metabolism of sedaxane in soil is faster [laboratory half-life valu es of 88-181 days (seed)] in the presence of germinating seed. This is supported by known literature that describes the influence of plant roots and germinating seeds on mi crobial activity in th e rhizosphere.

2 “ Guidance for Evaluating and Calculating Degradation Kinetics in Environmental Media ” Health Canada, U.S. Environmental Protection Agency, December 2011
3 The photolysis half-lives were calculated based on th e assumption that the average daily solar radiation is approximately 75% of the maximum intensity over a 12 hour period. This was taken into account in the comparison of the artificial light source and that of natural summer sunlight, conducted by the study authors. Because solar intensity of natural summer sunlight is likely not 100% during a 12 hour period, and because the sedaxane is proposed as a seed treatment and likely incorporated in the soil, the reviewers did not adjust the half-life values to represent 100% soil radiation over the 12 hour period.

### 6 Table 2 . Chemical Properties and Environmental Fate Parameters of Sedaxane

Parameter Value Source/Classification (Comments) Selected Physical/Chemical Parameters

Molecular formula C 18 H 19 F 2 N 3 O Calculated using ChemDraw

Molecular weight 331.37 g/mol Calculated using ChemDraw

Vapor pressure 20  C 6.5 x 10 -8 Pa 1.3 x 10 -9 atm 25  C 1.7 x 10 -7 Pa 1.3 x 10 -9 mm Hg

4.9 x 10 -10 atm MRID 47473326

Aqueous solubility at 25  C pH 6.5 14 mg/L MRID 47473326

Henry’s Law Constant calculated based on 14 g/m 3
and 1.7 x 10 -7 Pa at 25  C pH 6.5 4.0 x 10 -6 Pa m 3 /mol 3.95 x 10 -11 atm-m 3 /mol MRID 47473326 Calculated

Log octanol-to-water partition coefficient (log K OW ) at 25°C pH 6.67 3.3 (K OW =2100) MRID 47473326

Dissociation constant (pKa) None (pH 1-12) MRID 47473326

Transformation Mechanisms 1,2
Hydrolysis half-life at 20  C and 50  C No substantial degradation (pH 4, 7, and 9) MRID 47473318/ Acceptable

Aqueous photolysis half-life at 25  C 46 days (identified parent only) MRID 47473319/ Upgradable (up to 20% of the extracted residues were not identified)

Soil photolysis half-life at 20  C 253 days (average value) 213 days (pyrazole-label) 292 days (phenyl-label) MRID 47473446/ Supplemental MRID 47473447/

Supplemental

Aerobic soil metabolism halflife at 20°C 71days (SFO DT50)

IORE DT50= 63 d; DT90= 400 d; tR IORE = 120 d (Gatrenacker loam) extracted parent from seed studies *observed: DT50= 62-84 days DT 90=not observed MRID 47473444/ Supplemental (high application rate; seed treatment)

71 days (SFO DT50) 3 IORE DT50= 44 d; DT90= 883 d; tR IORE = 266 d (Marsillargues silty clay) extracted parent from seed studies *observed: DT50= 27-49 days DT 90=not observed MRID 47473445/ Supplemental (high application rate; seed treatment)

### 7 Parameter Value Source/Classification (Comments) 54 days (SFO DT50) 3 SFO DT50= 64 d; DT90= 212 d; SFO tR = 64 d (Gartenacker loam) extracted parent from seed studies *observed: DT50= 27-81 days DT 90=123-365 78 days (SFO DT50) SFO DT50= 78 d; DT90= 258 d; SFO tR = 78 d (Paperlacker loamy sand) extracted parent from seed studies *observed: DT50= 27-81 days DT 90=not observed

95 (SFO DT50) IORE DT50= 83 d; DT90= 8504 d; tR IORE = 2560 d (18 acres sandy clay)

extracted parent from seed studies *observed: DT50= 81-123 days DT 90=not observed 87 days (SFO DT50) SFO DT50= 87 d; DT90= 288 d; SFO tR = 78 d Gartenacker loam) extracted parent from seed studies *observed: DT50= 31-50 days DT 90=237-365

MRID 47473448/ Supplemental [high application rate; high levels of unextracted residues; some studieswere conducted on treated seeds; halflife values are calculated well beyond the study termination (up to 365 days)] 78 days (SFO DT50) IORE DT50= 34 d; DT90= 3763 d; tR IORE = 1130 d (California sand) extracted parent from seed studies *observed: DT50= 31-81 days DT 90=not observed 133 days [average of 105 (SFO DT50; phenyl) and 160 (SFO DT50; pyrazole) days]

DFOP DT50= 49 d; DT90= 894 d; DFOP Slow t 1/2 = 373 d (North Dakota clay loam, pyrazole) extracted parent from seed studies *observed: DT50= 80-122 days DT 90=not observed

DFOP DT50= 42.4 d; DT90= 1094 d; DFOP Slow t 1/2 = 544 d (North Dakota clay loam, phenyl) extracted parent from seed studies *observed: DT50= 31-50 days DT 90=not observed

tR DFOP Slow t 1/2 = 459 d (average of both labels)

296 days (SFO DT50) DFOP DT50= 222 d; DT90= 3005 d; DFOP Slow t 1/2 = 1200 d (Gartenacker loam) extracted parent from soil studies *observed: DT50= 241-367 days DT 90=not observed

### 8 Parameter Value Source/Classification (Comments)

373 days (SFO DT50) 3 DFOP DT50= 423 d; DT90= 3376 d; DFOP Slow t 1/2 = 1270 d (California sand) extracted parent from soil studies *observed: DT50= 241->367 days DT 90=not observed

400 days [average of 422 (SFO DT50;phenyl) and 377 (SFO DT50;pyrazole) days]

DFOP DT50= 98 d; DT90= >>365 d; DFOP Slow t 1/2 = 1280 d (North Dakota clay loam, pyrazole) extracted parent from soil studies *observed: DT50= 80-122 days DT 90=not observed

DFOP DT50= 437 d; DT90= 2306 d; DFOP Slow t 1/2 = 805 d (North Dakota clay loam, phenyl) extracted parent from soil studies *observed: DT50= 241-367 days DT 90=not observed

tR DFOP Slow t 1/2 = 1043 d (average of both labels)

Aerobic aquatic metabolism half-life (20  C) 849 (river; SFO DT50) and 920 (pond; SFO DT50) days (whole system) MRID 47473468/ Supplemental [high application rate; >10% applied radioactivity present as unextracted residues; half-life values are calculated well beyond the study termination (360 days)]

Anaerobic soil metabolism half-life (20  C) 375 days **dissipation half-life of extracted parent from seed studies ** MRID 47473443/ Supplemental [high application rate; >10% applied radioactivity present as unextracted

residues; study was conducted on treated seeds; half-life values are calculated well beyond the study termination (123 days)]

Anaerobic aquatic metabolism half-life (20  C) 4693 (river; SFO DT50) and 1970 (pond; SFO DT50) days (whole system) MRID 47473468/ Supplemental [high application rate; >10% applied radioactivity present as unextracted residues; half-life values are calculated well beyond the study termination (360 days)] Mobility Range of Freundlich soil-water

partition coefficients (K F ); 1/n value; andFreundlich organic carbonnormalized coefficients (K FOC ) 6.7, 2.8, 16.3, 3.1, 2.0, and 12.9 L/kg-soil; 0.81, 0.85, 0.90, 0.92, 0.87, and 0.83; and 256.6, 268.5, 587.5, 584.9, 662.5, and 528.9 mL/g OC MRID 47473461/ Acceptable

### 9 Parameter Value Source/Classification (Comments) Field Dissipation

Terrestrial field dissipation half-life Washington loamy sand: 31 days North Dakota sandy loam: 95 days California sandy loam: 31 days ( seed studies ) MRID 47473453/ Supplemental Washington loamy sand (in furrow 1.5 g/ha): 119 days Washington loamy sand (in furrow 91 g/ha): 132 days ( soil studies ) France silt loam: 119 days Italy silty clay loam: 131 days ( seed studies ) MRID 47473454/ Supplemental

1. Reported half-life values used in this assessment we re calculated using the draft NAFTA degradation kinetics 2 ; Single First Order (SFO), Nth-Order Rate Model or Indeterminate Order Rate Equation Model (IORE), and Double First-Order in Parallel (DFOP); Representative ha lf-life to be used to calculate model input value for IORE (tR IORE ). Values reported in the new chemical assessment are shown in italic . At the time of the new chemical a ssessment half-life values provided were based on single first order (SFO) rates that may not have represented the “best” fit or representative kinetic model for degradation. Selected representa tive half-life values are shown in bold

. 2. Reported half-life values are for total extracted sedaxane residues [(SYN524464) or SYN508210 (trans-isomer of sedaxane) and SYN508211 (cis-isomer of sedaxane) combined]. 3. Value was incorrectly reported in new chemical assessment.



### As mentioned above, a large amount of unextracted residues were observe d in the soil studies (up to 42% of the applied radioa ctivity). At least twice as much unextracted radioactivity was observed in some of the seed treatment studies. It is unclear if these residues are non-extracted residues or bound residues, or in th e case of the seed stud ies, residues sorbed to the seed coat or taken up by the roots (only shoots were examined separately from the soil). The extraction method employed in these studies was not verified for soil aged sedaxane residues or the transformation products. Furthermore, the uses of different extraction systems (different solvents) were not explored in the submitted st udies. Therefore, it cannot be determined if another solvent system may have been better suited for these studies.

The application rates used in all the submitted aerobic metabolism (seed and soil) studies are much higher (>15X) than the maximum proposed s eed treatment application rates for barley, canola, oat, rye, soybean , triticale, and wheat. For some chemi cals, the application rate has been shown to alter the degradation rate. For example, high application rates ma y adversely impact the microbial activity within a soil decreasing metabolism and limiting the potential identification of transformation products. The microbial activity of the treated soils was also not reported in the submitted studies; therefore, it cannot be determ ined if the soil remained active throughout the study.

Sedaxane is moderately mobile (mean K F 

### of and mean 7.3 L/kg-soil; 1/n ranged from 0.81-0.92; mean K FOC 

### of 481 L/kg OC 

### ; n=6). The leaching potential of sedaxane through soil is correlated with the organic carbon fraction of the soil. Based on the K OW 

### (log K OW 

### = 3.3) for sedaxane, it is not expected to bioaccumulate in aquatic and terrestria l organisms. A fish bioconcentration study confirms that accumulation does not occur. Seda xane is nonvolatile and volatilization is not expected to be a route of dissipati on for sedaxane in the environment.

### 10 Under conditions conductive to de gradation (aerobic soil metabolism and photolysis), sedaxane has been shown to form five major transfor mation products, including carbon dioxide. Two of the major transformation products, CDCD668094 and CDCD668095, retain both the pyrazole and the phenyl ring moieties. Both of these tr ansformation products were observed in aquatic photolysis experiments conducted with natura l water. Two other products, CSCD465008 and CSAA798670, are pyrazole ring amide cleavage produc ts with and without the N-methyl group, respectively. Both of these transformation pr oducts were observed under aerobic soil conditions, while only CSAA798670 was observed in photode gradation studies. Several other minor degradation products were observed in th e degradation studies including: CSCC210616, CSCD728931 and CSCD667584. A number of other minor transformation products were not identified in the submitted studies.

C. Ecological Effects Summary

Based on the available data, sedaxane is highly toxic to freshwater fish ; moderately toxic to estuarine/marine fish and freshwater and estu arine/marine invertebrates; and practically nontoxic to birds, mammals, and terrestrial inverteb rates (contact) on an acute exposure basis (Table 3). Chronic exposure resulted in reduced post-hatch survival (100%) in freshwater fish (fathead minnows). Chronic exposure in freshwater invertebrates resulted in reduced offspring production (NOAEC = 0.75 mg a.i./L). Chroni c toxicity data are not available for estuarine/marine fish or estuarin e/marine invertebrates. Chronic exposure in birds resulted in no effects at the highest concentration tested, i.e ., 1,050 mg a.i./kg-diet. Chronic exposure resulted in reduced body weights, reduced weight ga in, and food consumption in mammals (NOAEL = 41 mg a.i./kg-bw).

For terrestrial plants, the EC 25 

### values were greater than the hi ghest application rate of 0.0956 lb a.i./acre in the seedling emergence study for both monocots and dicots. The most sensitive aquatic plant tested was the green algae P. subcapitata with an EC 50 

### value of 1.6 mg a.i./L based on reduced biomass and mean cell density.

Toxicity data for the degradate CSCD465008 were available for freshwater fish, aquatic invertebrates and freshwater alg ae as well as for mammals. Based on the data for the freshwater organisms, CSCD465008 appears to be less toxic than the parent as it is practically non-toxic to fish and invertebrates with LC 50 

### and EC 50 

### values of >97 and >91.8 mg a.i./L, respectively. The degradate’s EC 50 

### value for green algae was >92.5 mg a. i./L. The acute oral study for mammals (rat) resulted in a non-definitive value (LD 50 

### >2000 mg/kg bw) for the degradate. As the limit concentration for the degradate was lower than the LD 50 

### value for parent ( i.e ., 5000 mg/kg-bw), it is not possible to do a comparison of toxicity. As such, this assessment will focus on parent sedaxane.

### 11 Table 3. Summary of Specific Measurement Endpo ints for Animals and Plants Considered in this Assessment
TAXA MEASURE OF EFFECT Survival, growth and/

or reproduction of: Species Toxicity Endpoint

Freshwater Fish Acute

Cyprinus carpio Carp 96-hr LC 50 = 0.62 mg a.i./L NOAEC = 0.37 mg a.i./L; LOAEC = 0.73 mg a.i./L based on mortality and sub-lethal effects including surfacing, lethargy, loss of equilibrium, and lying on the bottom. Chronic

Cyprinus carpio Carp NOAEC = 0.11 mg a.i./L 1 Based on an acute-tochronic ratio (ACR=5.5) using fathead minnow acute and chronic endpoints and acute carp endpoint; LOAEC in the chronic fathead minnow study was based on reduction in post-hatch survival at the 469 μg a.i./L test concentration (100% mortality for this treatment group)

Freshwater Invertebrates Acute

Daphnia magna Water flea 48-hr EC 50 = 5.96 mg a.i./L NOAEC = 1.6 mg a.i./L (based on immobility); no other sublethal effects noted Chronic

Daphnia magna Water flea 21-d NOAEC = 0.75 mg a.i./L LOAEC (2.4 mg a.i./L) based on reduced offspring production (no offspring produced at this concentration).

Estuarine/Marine Fish Acute

Cyprinodon variegates

Sheepshead minnow 96-hr LC 50 = 4.2 mg a.i./L NOAEC = 0.67 mg a.i./L (based on lethargy, loss of equilibrium, and lying on the bottom). Chronic

Cyprinodon variegates

Sheepshead minnow NOAEC = 0.76 mg a.i./L 2 Estuarine/Marine chronic fish study not available; NOAEC based on an acute-to-chronic ratio (ACR=5.5) using fathead minnow acute and chronic endpoints and acute sheepshead endpoint Estuarine/Marine Acute

### 12 TAXA MEASURE OF EFFECT Survival, growth and/

or reproduction of: Species Toxicity Endpoint

Invertebrates Americamysis bahia Mysid shrimp 96-hr LC 50 = 1.5 mg a.i./L NOAEC = 1.2 mg a.i./L (based on surfacing and erratic swimming).
Crassostrea virginica Eastern oyster 96-hr EC 50 = 3.5 mg a.i./L NOAEC = 1.3 mg a.i./L (based on inhibition of shell growth). Chronic

Americamysis bahia Mysid shrimp NOAEC = 0.19 mg a.i./L 3 Estuarine/Marine chronic invert study not available; NOAEC based on an acute-to-chronic ratio (ACR=7.9) using Daphnia acute and chronic endpoints and acute mysid endpoint Aquatic Plants Vascular Plants
Lemna gibba

Duckweed 7-d EC 50 = 2.7 mg a.i./L Based on reduced dry weight. NOAEC = 1.2 mg a.i./L Based on reduced dry weight. Non-vascular Plants

Pseudokirchneriella subcapitata Algae 96-hr EC 50 = 1.6 mg a.i./L Based on reduced biomass and mean cell density 96-hr NOAEC = 0.99 mg a.i./L Based on reduced biomass, growth rate, yield, and cell density

Birds Acute
Colinus virginianus Northern bobwhite quail 14-d LD 50 >2,250 mg a.i./kg-bw No effects were noted in the study; NOAEL = 2,250 mg a.i./kg-bw

Serinus canaria Canary 14-d LD 50 >2,000 mg a.i./kg-bw NOAEL < 2,000 mg a.i./kg-bw based on reduced female body weight and sublethal effects including loss of coordination and lethargy Sub-acute

Colinus virginianus Northern bobwhite quail 5-d LC 50 >5,870 mg a.i./kgdiet NOAEC = 3,370 mg a.i./kg-diet based on reduced body weight gain (LOAEC = 5,870 mg a.i./kg-diet) (no mortality) Chronic Anas platyrhynchos Mallard duck 22-wk NOAEC = 1,050 mg a.i./kg-diet No effects were noted in the study

Mammals Acute Rattus Norvegicus Rat LD 50 = 5,000 mg a.i./kg-bw No effects were noted in the study Chronic

### 13 TAXA MEASURE OF EFFECT Survival, growth and/

or reproduction of: Species Toxicity Endpoint

Rattus Norvegicus Rat 2-gen NOAEL = 41 mg/kgbw (males) LOAEL (120 mg/kg-bw) based on decreased body weights, body weight gains, and food consumption

Terrestrial Invertebrates Acute Contact Apis mellifera

Honey Bee 48-hr LD 50 > 98.2 μg a.i./bee There was 17.5% mortality at the limit dose Acute Oral Apis mellifera

Honey Bee 48-hr LD 50 > 4.22 μg a.i./bee There was 12.5% mortality at the limit dose. Sub-acute

Eisenia fetida

Earthworm LC 50 > 1,000 mg a.i./kg dw soil Increased % weight loss at two highest concentrations (NOAEC = 250 mg a.i./kg dw soil); no mortality.

Terrestrial Plants Seedling Emergence

Monocots and dicots 21-d EC 25 >0.0956 lbs a.i./acre None

21-d NOAEC = 0.0956 lbs a.i./acre For corn and tomato there was 13 and 10% inhibition in dry weight, respectively, and 6 and 8% inhibition in mean shoot height, respectively.

1 This value is based on an acute-to-chronic ratio (ACR) using acute data from the carp and acute and chronic data from fathead minnow [acute carp LC 50 = 0.62 mg a.i./L; acute fathead minnow LC 50 = 0.91 mg a.i./L; chronic fathead minnow NOAEC = 0.165 mg a.i./L; fathead minnow ACR = 5.5 ( i.e ., 0.91/0.165 = 5.5); carp NOAEC = 0.11 (0.62/ x

= 5.5)].
2 This value is based on an acute-to-chronic ratio (ACR) using acute data from the sheepshead and acute and chronic data from fathead minnow [acute sheepshead minnow LC 50 = 4.2 mg a.i./L; acute fathead minnow LC 50 = 0.91 mg a.i./L; chronic fathead minnow NOAEC = 0.165 mg a.i./L; fathead minnow ACR = 5.5 ( i.e ., 0.91/0.165 = 5.5); sh eepshead NOAEC = 0.76 (4.2/ x= 5.5)].
3 This value is based on an acute-to-chr onic ratio (ACR) using acute data from th e mysid and acute and chronic data from daphnia [acute mysid LC 50 = 1.5 mg a.i./L; acute daphnia LC 50 = 5.96 mg a.i./L; chronic Daphnia NOAEC = 0.75 mg a.i./L; Daphnia ACR = 7.9 ( i.e ., 5.96/0.75 = 7.9); mysid NOAEC = 0.19 (1.5/ x

= 7.9)].



### D. Exposure Characterization

Aquatic Exposure from Sedaxane Use

Tier 1 surface water modeling for the proposed se daxane use rates on corn, dried shelled pea and beans, rapeseed and sorghum, and potato, were conducted using environmental fate data shown in Table 4 . Surface water modeling was conducted using GENEEC (version 2). The application rate, number, and interval for sedaxane use on dried shelled pea and beans, rapeseed and sorghum are shown in Table 5. Output files for GENEEC model simulations are shown in Appendix A.

### 14 Table 4. Input Parameters Used in GE NEEC Modeling to Estimate Sedaxane Concentrations Resulting From the Proposed Uses on Corn, Dried Shelled Pea and Beans, Rapeseed and Sorghum, and Potato

Input Parameter (Symbol; Unit) Value for Sedaxane Reference

Molecular Weight 331.37 g/mol Calculated using ChemDraw
Henry’s constant (25 o C) 3.95 x 10 -11 atm-m 3 /mol MRID 47473326 Calculated

Vapor Pressure 25  C 1.7 x 10 -7 Pa 1.3x10 -9 torr 20  C 6.5 x 10 -8 Pa 4.9x10 -10 torr 47473326

Solubility in Water (mg/L at 20 o C) 14 47473326

Hydrolysis Half-life (t 1/2 at pH 7) 0, stable 47473318 Aquatic Photolysis Half-life (days; t 1/2 at pH 7) 46 1 47473319 Aerobic Soil Metabolism [upper 90 th percentile confidence bound on the mean half-life value (t 1/2 ; days)] 410 47473448

Aerobic Aquatic Metabolism Half-life [water column; upper 90 th percentileconfidence bound on the mean halflife value (t 1/2 ; days)] 994 47473468

Anaerobic Aquatic Metabolism Halflife [benthic; upper 90 th percentileconfidence bound on the mean halflife value (t 1/2 ; days)] 7522 47473468

Average Soil Partition Coefficient (K oc ; mL/g) K foc = 481 mL/g 47473461 Gray shading indicates data that are not consid ered in GENEEC; however, the parameters are provided for completeness for possible Tier II modeling is required in the future. 1. Dark control-adjusted (rate of irradiated – rate of non-irradiated) as well as adjusted to a 12-hour/day photoperiod at 40 °N latitude. The artificial light source used in this experiment was determined to be equivalent to 0.9 days at 40 °N latitude.



### Table 5: Application Information for Sedaxan e Use on Corn, Dried Shelled Pea and Beans, Rapeseed and Sorghum, and Potato

Use Number of Applications/ Application Rate (lb a.i./A) Interval Between Applications (days)

corn a 2/0.013 30 or 138

sorghum 2/0.0046 30

dried shelled pea and bean 2/0.002 30

### 15 Use Number of Applications/ Application Rate (lb a.i./A) Interval Between Applications (days)

rapeseed 2/0.0003 30

Potato a 1/0.1 138

corn-wheat rotation b 1/0.013 and 1/0.008 138

a. Since the highest single application is for corn and it can be reapplied after crop failure it is the only scenario modeled, except for potato which was also modeled. b. Wheat is another registered crop for sexadane and may be rotated with corn



### Surface Water Modeling for Corn, Dried Shelled Pea and Beans, Rapeseed, and Sorghum Seeds and Potato Pieces

From the proposed sedaxane use on corn, dried shelled pea and beans, rapeseed and sorghum seeds and potato pieces, use on corn and potato are expected to result in the highest EECs. The estimated environmental concentrations (EECs) from use on corn are not expected to exceed 0.78 μg/L for the daily peak, 0.77 μg/L for the 21 day average, and 0.71 μg/L for the 60 day average. For potato, the EECs are 3.09 μg/L for the daily peak, 3.02 μg/L for the 21 day average, and 2.90 μg/L for the 60 day average. Sedaxane EECs from corn and potato use are shown in Table 6. Model inputs and outputs are presented in Appendix A.

Table 6. 

### Tier I GENEEC Estimated Environmental Co ncentrations of Sedaxane in Surface Water for Seed Treatment on Corn Seeds (the highest estimated EEC)

Crop Estimated Environmental Concentration Peak 21-Day Average 60-Day Average μg/L Corn 0.78 0.77 0.71 Potato 3.09 3.02 2.90



### Monitoring Data

No monitoring data is available at this time as sedaxane was only recently registered in the United States.

### 16 Terrestrial Exposure from Sedaxane Use on Co rn, Dried Shelled Pea and Beans, Rapeseed and Sorghum seeds

Exposure to terrestrial animal s was estimated using T-REX version 1.4.1 (potato) and 1.5.1(corn) (Table 7). The following tables provide the terr estrial EECs used in this assessment. For seed treatments, T-REX only models a single seed pl anting per year, therefor e, if an additional planting per year occurred as allowed by the la bel, this would underestimate the potential exposure to non-target organisms on a yearly basi s, except for potatoes. Based on the proposed label, application to potato piec es is to occur only every other year. As use on corn and potato are anticipated to prov ide the highest EECs, only these uses were modeled. T-REX v.1.5.1 does not allow for custom seeding rates (lb seed/A), bu t rather uses default va lues (default for potato is 5271 lb seed/A; custom seeding rate in this as sessment 3333 lb seed/A), th erefore, this version could not be used to model potatoes. Theref ore, T-REX v1.4.1 was used to model potatoes, however, this version only calcula tes RQ values for small birds a nd mammals. However, the RQ values for small birds and mammals are conservativ e for the other class si zes. Model inputs and outputs are presented in Appendix B.

Table 7. Terrestrial Avian and Ma mmalian Estimated Environmental Co ncentrations for Sedaxane from Use on Corn Seeds

Animal

Size Crop Maximum Application Rate Maximum Seed Application Rate Avian Nagy Dose Mammalian Nagy Dose Available AI

(lbs ai/A) (mg ai/kg seed) (mg ai/kgbw/day) (mg ai/kgbw/day) (mg ai ft-2)

Small corn, all or unspecified 0.013 1 359.23 90.92 76.11
0.13 1 Medium 51.84 52.60

Large 23.21 12.2

Small potato 0.1 30.00 7.59 6.36
1.04 Medium

-- 2

--

Large -- -- 1 Due to rounding and assumptions in product density, T-REX v1.5.1 calculates this rate as 0.012 lb a.i./A which slightly influences the max. seed app. rate and Nagy dose s. However, this slight di fference is not expected to significantly influence RQs or risk conclusions in this assessment.
2 T-REX v1.4.1 only calculates EECs for small birds and mammals, however, this w ill represent a conservative estimate for the other animal size classes.



### EECs for terrestrial plants inha biting dry and wetland areas are derived using TerrPlant (version 1.2.2, 12/26/2006). TerrPlant estimates potential exposure from a single application using default assumptions for runoff and spray drift (Table 8). While the potential for dust from abraded seeds during planting may occur, the amount of dust is not known and since it is a seed treatment conventional routes of spray drift are not expected, so only the runoff values will be used in this assessment. EECs are based upon solubility, applica tion rate and minimum incorporation depth. A complete description of the input parame ters and output is in Appendix C.

### 17 Table 8 

### . EECs on Plants from Run-off Following Label-Specified Applications of Sedaxane Using the TerrPlant Model (lbs a.i./A)

Crop Application Rate (lb a.i./acre) EEC – Runoff to Dry Areas (lb a.i./acre) EEC – Runoff to Semi-aquatic

Areas (lb a.i./acre) Corn 0.013 0.00013 0.0013 Potato 0.1 0.001 0.01

E. Risk Assessment Summary

Aquatic Species

1. Fish

Table 9 

### indicates that neither the acute nor chronic LOCs are exceeded for either freshwater fish or aquatic-phase amphibians or estuarine/marine fish with the highest estimated peak and 60-day average EEC values.

Table 9. Summarized Acute and Chronic Fish Risk Quotients for Sedaxane Use on Corn and Potato Seeds

Scenario Freshwater Fish/Aquatic-Phase Amphibians (Acute) 1,2,4 Freshwater Fish (Chronic) 1,2,4 Estuarine/Marine Fish (Acute) 1,3,4 Estuarine/ Marine Fish (Chronic) 1,3,4

Corn <0.01 <0.0 1 <0.01 <0.01

Potato <0.01 0.03 <0.01 <0.01

1 Corn: peak EEC 0.78 μg a.i. /L, 60-day average EEC 0.71 μg a.i./L. Potato: peak EEC 3.09 μg a.i./L, 60-day average EEC 2.90 μg a.i./L
2 Acute and chronic toxicity endpoints were 620 μg a.i./L (LC 50 ) and 110 μg a.i./L (NOA EC), respectively, for freshwater fish.
3 Acute and chronic toxicity endpo ints4200 were μg a.i./L (LC 50 ) and 760 (NOAEC), respectively, for estuarine/marine fish.
4 Risk Quotients are calculated using the following formulas: EEC/LC 50 for acute exposure and EEC/NOAEC for chronic exposure
5 Acute LOC for freshwater fish = 0.05 for endangered species, 0.1 for restricted use, and 0.5 for non-listed species



### 2. Aquatic Invertebrates

Table 10 indicates that neither the acute nor chronic levels of concern (LOC) are exceeded for freshwater invertebrates. For estuarine/marine invertebrates, the acute and chronic LOC is not exceeded.

### 18 Summarized Acute and Chronic Aquatic Invertebrate Risk Quotients for Sedaxane Use on Corn and Potato Seeds

Table 10. 

### Summarized Acute and Chronic Aquatic Invert ebrate Risk Quotient s for Sedaxane Use on Corn and Potato Seeds

Scenario Freshwater Inv. (Acute) 1,2.4 Freshwater Inv. (Chronic) 1,2,4 Estuarine/Marine Inv. (Acute) 1,3,4 Estuarine/Marine Inv. (Chronic) 1,3,4

Corn <0.01 <0.0 1 <0.01 <0.01

Potato <0.01 <0 .01 <0.01 <0.01

1 Corn: peak EEC 0.78 μg a.i./L, 21-d ay average EEC 0.77 μg a.i./L. Potato: peak EEC 3.09 μg a.i./L, 21- day average EEC 3.02 μg a.i./L
2 Acute and chronic toxicity endpo ints were 5960 μg a.i./L (LC 50 ) and 750 μg a.i./L (NOAEC), respectively, for freshwater invertebrates.
3 Acute and chronic toxicity endpo ints were 1500 μg a.i./L (LC 50 ) and 190 μg a.i./L (NOAEC), respectively, for estuarine/marine invertebrates.
4 Risk Quotients are calculated using the following formulas: EEC/LC 50 for acute exposure and EEC/NOAEC for chronic exposure
5 Acute LOC for freshwater and marine/estuarine invertebrates = 0.05 for endangered species, 0.1 for restricted use, and 0.5 for non-listed species



### 3. Aquatic Plants

Table 11 

### indicates that the LOCs for aquatic non-vasc ular and vascular plants are not exceeded for the proposed uses.

Table 11Aquatic Plant Risk Quotients for Sedaxane Use on Corn and Potato Seeds

Scenario Non-vascular Plants (Non-listed) Non-vascular Plants (Listed) Vascular Plants (Non-listed) Vascular Plants (Listed)

Corn RQ < 0.01 RQ <0.01 RQ < 0.01 RQ < 0.01

Potato RQ < 0.01 RQ < 0.01 RQ < 0.01 RQ < 0.01

1 Corn peak EEC 0.78 μg a.i./L. Potato: peak EEC 3.09 μg a.i./L
2 Endpoints are 1600 μg a.i./L (EC 50 ) and 990 μg a.i./L (NOAEC) for non-vascular plants and 2700 μg a.i./L (EC50) and 1200 μg a.i./L (NOAEC) for vascular plants .
3 Risk Quotients are calculated using the following formula: EEC/EC 50 4 LOC for aquatic plants = 1



### Terrestrial Species

4. Birds, Reptiles and Terrestrial-Phase Amphibians

There are no toxicity studies available for reptiles or terrestrial-phase amphibians. Therefore, birds are used as a surrogate. There were no mortalities in any of the available acute and

### 19 subacute avian studies. No RQs were calculate d; however, EECs were compared to the highest test dose to estimate how closely they appr oach or overlap the LOC. The highest dose/concentrations tested in the acute/subacute avian studie s were 2,250 mg a.i./kg bodyweight and 5,870 mg a.i./kg diet, respectively, both with bobwhite quail. Using comparisons between the terrestrial EECs estimate d from T-REX v. 1.4.1 or 1.5.1 ( Appendix B ) and the highest dose tested (adjusted for bodyweight of surrogate anim al size (20, 100, and 1000 g) in the acute oral study, the results show that for al l of the application rates, for the proposed uses, all of the EEC values are lower than one-half the highest dos e tested, which correlates to an LOC of 0.5 for non-listed birds. In evaluating risk to liste d birds, the EECs are not greater than 1/10 th 

### of the highest dose tested in the studies, which correlat ed to the acute listed LOC of 0.1, for small birds consuming corn seeds treated with sedaxane. In the acute oral study with canaries, there were sublethal effects observed at the limit dose of 2,000 mg a.i./kg-bw including reduced body weight, and loss of coordination and lethargy. When comparing th is limit dose to the EECs, the EECs are approximately 20 times lower than th e limit dose. Therefore, while there is uncertainty, the likelihood of adve rse effects from acute exposure is anticipated to be low.

Following chronic exposure, the chronic LOC for birds (LOC = 1) is not exceeded for birds (Table 12). Therefore, acut e and chronic risk to birds (s urrogates for terrestrial-phase amphibians and reptiles) is anticipated to be low.

Table 12. RQs for Avian and Mamma lian Species from Dietary Exposure to Sedaxane from Seed Treatments to Corn and Potato

Crop Risk Quotients† Avian (20 g) Mammalian (15 g) Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chronic corn, all or unspecified NA 1 NA 1 0.34 0.01 <0.01 0.84 Avian (100 g) Mammalian (35 g) Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chronic corn, all or unspecified NA 1 NA 1 0.34 0.01 <0.01 0.72 Avian (1000 g) Mammalian (1000 g) Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chronic corn, all or unspecified NA 1 NA 1 0.34 <0.01 <0.01 0.39 Avian (20 g) Mammalian (15 g) Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chronic
Potato 2 NA 1 NA 1 0.03 <0.01 0.01 0.07 3

1 RQs not calculated due to non-definitive endpoint (LD50 greater than highest concentration tested)
2 RQs not calculated for medium and large avian and mammalian class sizes due to model limitations in T-REX versions. However, RQs for small birds and mammals is conservative for other class sizes, and RQs for small animals do not exceed the LOC.
3 T-REX v1.4.1 calculates the chronic mammalian RQ us ing the chronic dietary NOA EC whereas T-REX v1.5.1 adjusts for body weight using the NOA EL, therefore this RQ was recalculated to account for body weight

Acute RQ #1 = (mg ai /kg-bw/day) / LD50 Acute RQ #2 = mg ai ft-2 /(LD50*bw)

### 20 Avian Chronic RQ = mg kg-1 seed / NOAEL Mammalian Chronic RQ = mg a.i./kg-bw/day / adjusted NOAEL



### 5. Mammals

Acute and chronic RQs did not exceed the LOC for mammals (Table 12).

6. Terrestrial invertebrates

The acute contact LD 50 

### for honey bees is >98.2 μg a.i./bee ; there was 17.5% mortality observed at this limit dose. Based on the acute contact t oxicity study to honeybees, se daxane is classified as practically non-toxic to honeybees. Toxicity in formation for beneficial insects in screeninglevel risk assessments is used to develop pre cautionary label language where necessary. Based on the available data, precautionary label language for bees is not necessary. However, the potential effects to larvae/pupae life stages of honeybees are unknown as the available data tested adult honeybees.

7. Terrestrial Plants

Terrestrial plants adjacent to the treatment area are considered in this assessment. The LOCs for risk to listed a nd non-listed terrestrial plants we re not exceeded for monocots or dicots (Table 13). However, there is some uncer tainty regarding the results for listed species. For corn and tomato there was 13 and 10% inhib ition in dry weight, resp ectively, and 6 and 8% inhibition in mean shoot height , respectively, in the available seedling emergence study at the limit concentration. For dry weight, the minimum significant difference that can be detected in the study, based on a power analysis, is approx imately 20% for corn and 44% for tomato. Therefore, there is uncertain ty regarding whether or not the true NOAEC is the limit concentration. The NOAEC or EC 05 

### is used to evaluate effects to listed terrestrial plants. Currently, the proposed single ap plication rate for seed trea tment for corn and potato is approximately 74X and 9.6X lower than the appl ication rate used in the study. Therefore, additional testing for corn and tomato is not ne eded at this time. However, if additional uses/rates are proposed, this wi ll be re-evaluated and it may be recommended that a Tier II seedling emergence study be conducted to better understand the potential effects to listed terrestrial plants.

Table 13. RQ values for plants in dry and semi-aquatic areas exposed to sedaxane fr om corn and potato seed use through runoff Plant Type Listed Status Dry Semi-Aquatic

Monocot listed <0.1 0.10

Dicot listed <0.1 0.10 *If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group.

### 21 8. Uncertainties

Exposure to dust from abraded se eds during planting may be a possi bility. If the assumption is that all of the sedaxane applied to the seeds is abraded and released as dust, then the maximum concentration that may be then deposited on dietary items is 0.013 lb a.i./A (calculated from the maximum seeding rate for corn). This application rate was used as the application rate for foliar application in T-REX and the EECs were compared to the limit concentration. For terrestrial invertebrates, the resulting ar thropod EEC was 1.9 mg/kg and the limit concentration was 767 μg a.i./g (converted to μg a.i./g based on the weight of one bee (0.128 g)), therefor e the EEC is 420 times lower than the limit dose. For birds and mammals consuming dietary items exposed to the dust, the application rate of 0.013 lb a.i./A was used as a folia r application, and all the resulting RQs were less than the LOC. For terrestrial pl ants, the application rate of 0.013 lb a.i./A is approximately at least 10X lower than the limit concentration used in the terrestrial plants toxicity testing. For aquatic organisms, the a ssumption was that all of the available sedaxane was available for entry into the aquatic environm ent therefore, the application rate of 0.013 lb a.i./A was used in deriving the RQs and no LOC exceedances were observed. Therefore, the likelihood for adverse effect from exposure to dust is anticipated to be low.

In the new chemical screening risk asse ssment for sedaxane (D386380), other effects uncertainties such as avian chronic and aquatic pl ant toxicity data as well as the observation of degradation products and their pot ential toxicity were discussed. However, those uncertainties are not anticipated to affect th e risk conclusions in this as sessment, except for possibly the chronic avian evaluation. The chronic repr oduction study with Northern bobwhite quail ( Colinus virginianus ) was classified as unacceptable (MRI D 47473475) because control mortality was 13% in the parental group, which is greater than the allowable 10%. Two females in the control died during the study with one found with head ca ught in caging; however, due to their deaths, their penmates were sacrificed which resulted in less than 90% overall survival at test termination (87%). Based on the study result s the reported NOAEC fo r the bobwhite quail (337 mg a.i./kg-diet) was lower than the mallard duck NOAEC used in this assessment (1050 mg a.i./kg-diet). As such, it appears that the bobw hite quail may be the more sensitive of the two tested species. If this NOAEC is used in th e RQ calculation for corn, then the RQ (1.19) would be slightly greater than the chr onic LOC of 1. The RQs for the othe r uses are less than the LOC. For corn, a reduction of 17% in the exposure rate would result in an RQ less than the LOC. In modeling exposure via treated seeds, the assumpti on is that there are enough seeds available for consumption to reach the LOC. Based on the in formation, it appears that the planting depth of corn is 2 inches, which may limit access to some seeds which should require the birds to glean a greater area to acquire enough seeds to reach the LOC. Based on the proposed label for corn, there is 0.1 mg a.i./seed and using a seeding rate of 33 lb seed/A that is 59,400 seeds/A which appears to be a high end estimate based on the BEAD memo. Using the application rate, the EEC is 400 mg a.i./kg seed which means that it would take 4,000 seeds to reach this EEC. A bird would need to glean every available seed in 2,900 sq. feet to consume enough a.i. to reach the EEC. As the seeds are anticipated to be buried, not all seeds should be available for gleaning. Additionally, the ability of the bird to consume 4,000 seeds in duration necessary to elicit a response may not be feasible. It is r ecognized that the energy requirements for birds in the lab are probably not the same as in the fiel d and the birds in the la b are fed a high nutrient

### 22 diet, therefore the toxic response in a bird in the field may be different than one in the lab. However, it seems that based on the necessary area and potentially available seeds, that the birds may not consume enough a.i. to reach the EEC. Therefore, an additional chronic study with bobwhite quail is not re quested at this time.

### 23 

## Appendix A GENEEC output

### 24 APPENDIX B T-REX v. 1.5.1 Corn

Chemical: Name of seed treatment formulation: Percent AI in formulation: 46% 0 8.33 Tested Body Weight (g) Avian LD50: 2000.00 26 1922.82 Small (20g) Avian repro. NOAEC: 1050.00 2447.85 Medium (100g) 3457.67 Large (1000g) Mammalian LD50: 5000.00 350 10989.15 Small (15g) Mammalian NOAEL: 820.00 8891.40 Medium (35g) 3845.80 Large (1000g)

Small (15g) 90.11 Medium (35g) 72.91 Large (1000g) 31.54

Crop Maximum Application Rate Maximum Seed Application Rate Avian Nagy Dose Mammalian Nagy Dose Available AI (lbs ai/A) (mg ai/kg seed) (mg ai/kg-bw/day) (mg ai/kg-bw/day) (mg ai ft-2) Small 90.92 76.11 Medium 51.84 52.60 Large 23.21 12.20

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chronic

corn, all or unspecified 0.05 0.003 0.34 0.01 0.00 0.84

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chronic

corn, all or unspecified 0.02 0.001 0.34 0.01 0.00 0.72

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chronic
corn, all or unspecified 0.01 0.00 0.34 0.00 0.00 0.39
† Acute RQ #1 = (mg ai /kg-bw/day) / LD50 Acute RQ #2 = mg ai ft-2 /(LD50*bw) Avian Chronic RQ = mg kg-1 seed / NOAEL Mammalian Chronic RQ = mg a.i./kg-bw/day / adjusted NOAEL Avian (1000 g) Mammalian (1000 g) Animal Size

corn, all or unspecified 0.012 359.23 0.12

Crop sedaxane vibrance Density of product (lbs/gal): Data inputs are in blue

Avian (100 g) Mammalian (35 g) Avian (20 g) Mammalian (15 g) Risk Quotients† Endpoints Adjusted LD50 Size class for adjusted LD50 Reported

Adjusted NOAEL for Mammals

### 25 Potato (potato not listed as a crop in T-REX 1.4.1, so inputs entered into barley row)

Chemical: Name of seed treatment formulation: Percent AI in formulation: 46% 0 8.33 Tested Body Weight (g) Avian LD50: 2000.00 26 1922.82 Avian repro. NOAEC: 1050.00

Mammalian LD50: 5000.00 350 10989.15 Mammalian NOAEC: 820.00

Crop Maximum Seeding Rate

(lbs/acre) Application Rate Application Rate (fl oz/cwt) (lbs. Ai/cwt) Barley 3333 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0.08 0.0030 beans 160 http://www.ext. nodak.edu/extpubs/plantsci/rowcrops/a1133-1.htm#Planting 0 0.0000 dried beans 160 http://www.ext. nodak.edu/extpubs/plantsci/rowcrops/a1133-1.htm#Planting 0 0.0000 lima beans (succulent) 100 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 snap beans 100 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000

Canola 5 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Corn 25 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Cotton 18 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Oats 87 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Onion 15 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 cowpeas/ blackeyed peas 50 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Pea 180 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 lupine 170 http://www.hort.pur due.edu/newcrop/afcm/lupine.html 0 0.0000 grain lupine 170 http://www.hort.pur due.edu/newcrop/afcm/lupine.html 0 0.0000 field peas 225 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Peanuts 135 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000

Rice 160 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Rye 109 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 Safflower 100 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Sorghum 8 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Soybeans 167 http://www.nsrl.uiuc. edu/aboutsoy/production02.html 0 0.0000 soybeans, edible 100 http://www.nsrl.uiuc. edu/aboutsoy/production02.html 0 0.0000

Sugar beets 8 http://www.agecon.ucdavis. edu/outreach/crop/Archives/SugarBeets.pdf 0 0.0000

Triticale 109 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0 0.0000 Wheat 156 http://www.ipmcenters.org/cropprofiles/CP_form.cfm 0

Crop Maximum Application Rate Maximum Seed Application

Rate Avian Nagy Dose Mammalian Nagy Dose Available AI (lbs ai/A) (mg ai/kg seed) (mg ai/kg-bw/day) ( mg ai/kg-bw/day ) (mg ai ft-2) Barley 0.1000 30.00 7.59 6.36 1.04 beans 0.00 0.00 0.00 0.00 0.00 dried beans 0.00 0.00 0.00 0.00 0.00 20 g Bird 5.061777181 lima beans (succulent) 0.00 0.00 0.00 0.00 0.00 15 g Mammal 3.178078065 snap beans 0.00 0.00 0.00 0.00 0.00 Endpoints Adjusted LD50 Reported

Nagy allometry
Food ingestion value g/day sedaxane

Reference Density of product (lbs/gal): Data inputs are in blue

Animal Questions? Comments? Click here

Acute (# 1) Acute (# 2) Chronic Acute (# 1) Acute (# 2) Chronic Barley 0.004 0.027 0.03 0.001 0.01 0.04 beans 0.00 0.00 0.00 0.00 0.00 0.00 dried beans 0.00 0.00 0.00 0.00 0.00 0.00 lima beans (succulent) 0.00 0.00 0.00 0.00 0.00 0.00 snap beans 0.00 0.00 0.00 0.00 0.00 0.00 Crop Avian (20 g) Mammalian (15 g) Risk Quotients†

### 26 APPENDIX C TERRPLANT v. 1.2.2 TerrPlant v. 1.2.2 Green values signify user inputs (Tables 1, 2 and 4). Input and output guidance is in popups indicated by red arrows.

Chemical Name PC code Use Application Method

Application Form Solubility in Water (ppm)

Input Parameter Symbol Value Units Application Rate A 0.013 lb a.i./A

Incorporation I 1 none Runoff Fraction R 0.02 none

Drift Fraction D 0 none

Equation EEC

(A/I)*R 0.00026 (A/I)*R*10 0.0026 A*D 0 ((A/I)*R)+(A*D) 0.00026 ((A/I)*R*10)+(A*D) 0.0026

Plant type EC 25 NOAEC EC 25 NOAEC

Monocot x 0.0956 x x

Dicot x 0.0956 x x

Plant Type Listed Status Dry Semi-Aquatic Spray Drift

Monocot non-listed #VALUE! #VALUE! #DIV/0! Monocot listed <0.1 <0.1 <0.1

Dicot non-listed #VALUE! #VALUE! #DIV/0! Dicot listed <0.1 <0.1 <0.1 Table 3. EECs for sedaxane. Units in lb a.i./A.

Runoff to dry areas Runoff to semi-aquatic areas Spray drift Total for dry areas

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group. Vegetative Vigor Seedling Emergence

Table 5. RQ values for plants in dry and semi-aquatic areas exposed to sedaxane through runoff and/or spray drift.* Table 4. Plant survival and growth data used for RQ derivation. Units are in lb a.i./A. Description

Total for semi-aquatic areas Table 1. Chemical Identity.
sedaxane

corn seeds

Table 2. Input parameters used to derive EECs. ground granule 14 129223

### 27 TerrPlant v. 1.2.2 Green values signify user inputs (Tables 1, 2 and 4). Input and output guidance is in popups indicated by red arrows.

Chemical Name PC code Use Application Method

Application Form Solubility in Water (ppm)

Input Parameter Symbol Value Units Application Rate A 0.1 lb a.i./A

Incorporation I 2 none Runoff Fraction R 0.02 none

Drift Fraction D 0 none

Equation EEC

(A/I)*R 0.001 (A/I)*R*10 0.01 A*D 0 ((A/I)*R)+(A*D) 0.001 ((A/I)*R*10)+(A*D) 0.01

Plant type EC 25 NOAEC EC 25 NOAEC

Monocot x 0.0956 x x

Dicot x 0.0956 x x

Plant Type Listed Status Dry Semi-Aquatic Spray Drift

Monocot non-listed #VALUE! #VALUE! #DIV/0! Monocot listed <0.1 0.10 <0.1

Dicot non-listed #VALUE! #VALUE! #DIV/0! Dicot listed <0.1 0.10 <0.1 Description

Total for semi-aquatic areas Table 1. Chemical Identity.
sedaxane

potato seeds

Table 2. Input parameters used to derive EECs. ground granule 14 129223

Table 3. EECs for sedaxane. Units in lb a.i./A.

Runoff to dry areas Runoff to semi-aquatic areas Spray drift Total for dry areas

*If RQ > 1.0, the LOC is exceeded, resulting in potential for risk to that plant group. Vegetative Vigor Seedling Emergence

Table 5. RQ values for plants in dry and semi-aquatic areas exposed to sedaxane through runoff and/or spray drift.* Table 4. Plant survival and growth data used for RQ derivation. Units are in lb a.i./A.