### 2 

# Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments in Support of the

Registration Review of Acibenzolar

- S

- methyl

CAS: 135158

- 54

- 2 PC Code: 061402

Environmental Fate and Effects Division Prepared by: Michael Lowit, Ph.D., Ecologist Steve Wente , Ph.D., Biologist U.S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division Environmental Risk Branch I 1200 Pennsylvania Ave., NW Mail Code 7507P Washington, DC 20460 Reviewed by: Faruque Kahn , Ph.D., Senior Fate Scientist Robin Sternberg , Ph.D., Wildlife Biologist 

# N N S S CH 3 

# O

### 3 Table of Contents

1. Purpose

................................ ................................ ................................ ................................ ........ 4 2. Problem Formulation

................................ ................................ ................................ .................. 4 2.1. Natur e of Regulatory Action

................................ ................................ ................................ 4 2.2. Previous Assessments

................................ ................................ ................................ .......... 4 2.2.1. E cological Risk Assessments

................................ ................................ ........................ 4 2.2.2. Drinking Water Exposure Assessments

................................ ................................ ........ 4 3. Stressor Source and Distribution

................................ ................................ ................................ 5 3.1. Mechanism of Action

................................ ................................ ................................ .......... 5 3.2. Ove rview of Pesticide Use and Usage

................................ ................................ ................ 5 3.3. Physical, Chemical, and Environmental Fate Properties of Acibenzolar

- S

- methyl and Its Degra dates

................................ ................................ ................................ ................................ ... 7 3.4. Clean Water Act

................................ ................................ ................................ .................. 9 4. Receptors

................................ ................................ ................................ ................................ .... 9 4.1. Effects to Aquatic Organisms

................................ ................................ ........................... 10 4.2. Effects to Terrestrial Organisms

................................ ................................ ....................... 13 4.3. Incident Databases Review

................................ ................................ ............................... 15 5. Exposure Pathways of Concern

................................ ................................ ............................... 16 6. Analysis Plan

................................ ................................ ................................ ........................... 16 6.1. Stressors of Concern

................................ ................................ ................................ .......... 17 6.2. Measures of Exposure

................................ ................................ ................................ ........ 17 6.3. Measures of Effect

................................ ................................ ................................ ............. 18 6.4. Integration of Exposure and Effects

................................ ................................ .................. 18 6.5. Endangered Species Assessments

................................ ................................ ...................... 18 6.6. Endocrine Disruptor Screening

................................ ................................ .......................... 19 6.7. Drinking Water Assessment

................................ ................................ .............................. 19 6.8. Preliminary Ide ntification of Data Gaps

................................ ................................ ............ 19 6.8.1. Environmental Fate Data

................................ ................................ ............................ 19 6.8.2. Ecological Effects Data

................................ ................................ ............................... 21 7. References

................................ ................................ ................................ ................................ 24 APPENDIX A. Submitted Environmental Fate and Effects Studies

................................ ........... 25 APPENDIX B. SIP v.1.0 Inputs and Outputs

................................ ................................ .............. 29 APPENDIX C. STIR v.1.0 Inputs and Outputs

................................ ................................ ........... 30 APPENDIX D. Chemical Names, Structures, and Maximum Reported Degradate Production in Environmenta l Fate Studies

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

### 4 1. Purpose The purpose of this problem formulation is to provide an understanding of what is known about the environmental fate, ecological e ffects, and currently registered uses of a cibenzolar

- S

- methyl ( also known as acibenzolar and CGA

- 245704 ). This document provides a plan for analyzing data relevant to acibenzolar

- S

- methyl and for conducting environmental fate, ecological risk, endangered species, and drinking water exposure assessments for its registered uses. Additionally, this problem formulation identifies data gaps, uncertainties, and potential assumptions used to add ress those uncertainties relative to characterizing the potential ecological risk associated with the registered uses of acibenzolar

- S

- methyl

.
2. Problem Formulation

2.1. Nature of Regulatory Action As part of the implementation of the new Registration Rev iew program 1 

### pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Agency is beginning its evaluation of acibenzolar

- S

- methyl to determine whether it continues to meet the FIFRA standard for registration. This pr oblem formulation in support of the registration review of acibenzolar

- S

- methyl will be posted in the initial docket which will be open to the public phase of the review process.

2.2. Previous Assessments

2.2.1. Ecological Risk Assessments

Acibenzolar

- S

- me thyl was first registered in the US in 2000 as a fungicide for use on a variety of food crops. Previous Section 3 assessments for acibenzolar

- S

- methyl concluded no risk concern to any taxonomic groups ( DP258689, DP317996, DP 351609, DP371759, and DP386929) 2 

### except chronic risk to mammals from sunflower seed use (DP398630)

. 2.2.2. Drinking Water Exposure Assessments The most recent drinking water assessment (DWA) in support of human health risk assessment was conducted to support the registration of acibenzo lar

- S

- methyl for use on the low growing berry subgroup 13

- 07G (DP 386365)

. The maximum drinking water exposure estimates are for

use on cucu rbits: (1) acibenzolar

- S

- methyl concentrations are 0.72 μg/L (1

- in

- 10

- year peak), 0.16 μg/L (1

- in

- 10

- year annual me an), and 0.11 μg/L (30

- year mean) for surface water and 1.25 x 10 - 5 

### μg/L for ground water and (2) CGA

- 210007 concentrations are 20.02 μg/L (1

- in

- 10

- year peak), 19.11 μg/L (1

- in

- 10

- year annual mean), and 16.64 μg/L (30

- year mean) for surface water and 8.12 x 10 - 2 

### μg/L for ground water.

1 http://www.epa.gov/oppsrrd1/registration_review/
2 DP258689 (3/00; leafy vegetable, cole crop, tomato, tobacco) , DP317996 (7/06; cole crop, tomato

, fruiting vegetable, lettuce, spinach, tobacco), DP 351609 (2/09; cucurbit, dry onion bulb) , DP371759 (8/10; turf, cotton seed) , and DP386929 (5/11; low growing berry subgroup 13

- 07G)

### 5 3. Stressor Source and Distribution

3.1. Mechanism of Action

Acibenzolar is a fungicide in the benzothiadiazole class t h at work s systemically by increasing enzymes in the plant, which then can degrade fungal and bacterial cell walls. The physiological process induced by acibenzolar

- S

- methyl treatment is achieved by the triggering of systemic activated resistance (SAR) within plants. This natural resistance can be induced biologically whenever a plant is attac k ed by l ow levels of pathogen inoculum.

3.2. Overview of Pesticide Use and Usage

Acibenzolar

- S

- methyl u ses and application rates are based on the most recent label data report (Label Use Information System report; LUIS, 7 / 11 / 2013 ) provided by the Biological and Economic Analysis Division (BEAD). Maximum application rates, minimum application intervals, and application methods are indicated in Table 1 . The registration review risk assessment will be based on current label information at the time of assessment as provided by BEAD.

To reduce uncertai nty in the risk assessment, EFED is request ing that the registrant provide additional label information where necessary on the minimum application interval (commercial/industrial lawns and ornamental lawns/turf)

. Additionally, EFED requests clarification on the maximum number of application s for transplant production uses

. EFED does not anticipate that using seasonal rates (as stated on current labels) instead of an annual maxi mum application rate would substantially affect the acibenzolar

- S

- methyl risk
assessment because both acibenzolar

- S

- methyl and CGA

- 210007 (major degradate of concern ) have short degradation half

- lives (aerobic soil metabolism t 1/2 

### of 0.22 days for acibenzo lar

- S

methyl and 16.5 days for CGA

- 210007) relative to the duration of a crop season ( i.e. , there will be little build up of acibenzolar

- S

- meth yl or CGA

- 210007 across seasons). However, i n the absence of labeled annual maximum application rates (or maximu m number of crop seasons/year), EFED will assume multiple crop seasons for applicable crops and make conservative assumptions about the number of seasons based on best available information.

Acibenzolar

- S

- methyl was primarily used on spinach crops in terms amount of product applied (1000 lb ai) and percent crop treated (35% on average) from 2004

- 2011 according to the Screening Level Usage Analysis prov id ed by BEAD (12/6/2012). Acibenzolar

- S

- methyl was applied ≤ 5% (on average) to all other crops.

### 6 Table 1 . Maximum Rates for Registered Uses of Acibenzolar

- S

- m ethyl

Use Method of Application Maximum Single Application Rate (lb ai/A) Maximum Number of Applications

(Assumed) Minimum Application

Interval ( D ays) Seasonal Maximum Application Rate (lb ai/A)

Cole Crops Aerial
Ground Chemigation 1 0.031 3 4 7 0.125

Commercial / Industr ial Lawns Ground 0.02 3 4 NS (2) NS 0.05 3

Cotton Seed Treatment 1.98 x 10 - 10
lb/seed NS NS 0.0002

Cucurbit Vegetables Band Treatment
Aerial
Ground
Ch emigation

– (d rip i rrigation) 0.0625 NS (4) 7 0.25

Fruiting Vegetables Band Treatment
Aerial
Ground Chemigation 1 0.0234 8 7 0.1875

Golf Course Turf Ground 0.023 4 NS (6) 14 0.1487

Lettuce Band Treatment
Aerial
Ground Chemigation 1 0.0313 4 7 0.125

Onion Band Treatment
Aerial
Ground Chemigation 1 0.0313 NS (4) 7 0.125

Ornamental Lawns and Turf Ground 0.023 4 NS (2) NS 0.053

Ornamental Sod Farm (Turf) Ground 0.023 4 NS (1) NS 0.026

### 7 Use Method of Application Maximum Single Application Rate (lb ai/A) Maximum Number of Applications

(Assumed) Minimum Application

Interval ( D ays) Seasonal Maximum Application Rate (lb ai/A)

Pepper (including chili type) Band Treatment
Aerial
Ground Chemigation 1 0.0234 8 7 0.1875

Soil/media
T reatment (drip feed at seeding

– transplant production) 1.1 x 10 - 7 lb/cell NS (1) NS NS

Small Fruits Band Treatment
Aerial
Ground 0.0234 NS (8) 7 0.1875

Spinach Band Treatment
Aerial
Ground Chemigation 1 0.0234 3 7 0.0703

Sunflower Seed Treatment 6.0 x 10 - 8 lb/seed NS NS 0.005

Tobacco Aerial
Ground Directed Spray 0.0156 3 10 0.0469

Foliar Treatment (pre

- transplant) 6.3 x 10 - 7 lb/plant NS (1) NS NS

Tomato Band Treatment
Aerial
Ground Chemigation 1 0.0234 8 7 0.1875

Soil/media
T reatment (drip feed at seeding

– transplant production) 1.1 x 10 - 7 lb/cell NS (1) NS N S

NS

– not stated on the label
1 D rip irrigation and overhea d sprinkler irrigation

.



### 3.3. Physical, Chemical, and Environmental Fate Properties of Acibenzolar

- S

m ethyl and Its Degradat es

Registrant

- submitted studies ( Table 2 ) indicate that acibenzolar

- S

- methyl neither readily moves to surface water nor leaches to ground water due to its poor water solubility (7.7mg/L) and short degradation half

- life in aerobic soil (t 1/2 

### = 0.22 days), aerobic aquatic metabolism (t 1/2 

### = 0.63

### 8 days), and aqueous photolysis (t 1/2 

### = 0.025 days) studies. A cibenzolar is unlikely to volatilize given its Henry’s l aw c onstant of 1.26 × 10 - 7 

### atm m 3 

### mole - 1 

### and vapor pressure of 3.5 × 10 - 6 

### mm Hg @ 25  ̊ C

. A bioaccumulation study of bluegill sunfish ( Lepomis macrochirus ) under flow

through test conditions indicated mean bioconcentration factors (BCFs) of 48 in fillet, 199 in viscera, and 118 in whole fish samples.

The primary pathway of acibenzolar

- S

- methyl degradation in aerobic soil involves cleavage of the thioester to form a carboxylic acid derivative, 1,2,3

- b enzothiadiazole

- 7

- carboxylic acid (CGA

- 210007). In non

- sterile aerobic soil, CGA

- 210007 reached 62.5% of the applied acibenzol ar

- S

- methyl in 6 hrs and peaked on day 3 at 99%. For sterile soil, CGA

- 210007 reached 35.3% in 6 hrs and a maximum of 60.2% by day 7. In the aqueous photolysis study, acibenzolar

- S

- methyl rapidly degraded into several unknown compounds (at 25  ̊ C in steril e aqueous sodium acetate buffer solution (pH 5)). The pseudo first order half

- life was 0.025 days. After 30 days, the major degradates of aqueous photolysis were CO 2 

### (33.4% formation), A8 (25%), and A9 (19%). In the dark environment, CGA

- 210007 accumula ted at a rate inversely proportional to the decline of acibenzolar

- S

- methyl , reaching 8.4% (maximum) of the applied acibenzolar

- S

- methyl in 30 days. Compared to acibenzolar

- S

- methyl , CGA

- 210007 is a relatively stable compound with a longer residue half

- li fe in aerobic soil (t 1/2 

### = 16.5 days) and higher water solubility (225 mg/L); thus, it is more readily available for lateral and vertical downward movement to surface and groundwater. Consequently, CGA

- 210007 exhibits greater exposure potential following application. Studies submitted by the registrant are listed in Appendix A

. Appendix D provides the structures of acibenzolar

- S

- methyl and its degradates as well as the maximum reported degradate production in the submitted environmental fate studies.

Ta ble 2

. Environmental Fate and Transport Properties of Acibenzolar

- S

- m ethyl and CGA

- 210007 (Major Degradation Product) Parameter Value Reference
Acibenzolar

- S

- methyl

Chemical Name 1,2,3 benzothiadiazole

- 7

- carbothioic acid, S

methyl ester MRID 47833601

Molecular Formula C 8 H 6 N 2 OS 2 MRID 47833601 Molecular Weight 210.3 g/mol MRID 47833601 SMILES Code c1ccc2N=NSc2c1C(=O)SC EPI Suite (v 3.20) Melting Point 132.9 o C MRID 45434102_CA Vapor pressure (25°C) 3.5 × 10 - 6 mm Hg @ 25 o C MRID 47833602 Henry’s Law Constant 1.26 × 10 - 7 atm m 3 mole - 1 Calculated Solubility (pH 6, 20 o C) 7.7 mg/L MRID 47833602

Hydrolysis (t 1/2 ) pH 5, 1,387 days pH 7, 161.7 days pH 9, 0.81 days MRID 44014252

Aqueous Photolysis (t 1/2 ) 0.025 days at pH 7 MRID 44537034 Soil Photolysis (t 1/2 ) 1.0 days MRID 44537035

Aerobic Soil Metabolism (t 1/2 ) 0.22 days MRID 44014253 MRID 44537036 Aerobic Aquatic Metabolism (t 1/2 ) 0.63 days MRID 44537038 Anaerobic Soil Metabolism (t 1/2 ) N/A No data Anaerobic Aquatic Metabolism (t 1/2 ) 3.98 days MRID 44537037
K oc (median) 1893 ml/g MRID 44537041

### 9 Parameter Value Reference
CGA

- 210007 (Major degradate) Chemical Name 1,2,3

- b enzothiadiazole

- 7

- carboxylic acid MRID 44537042 Molecular formula C 7 H 4 N 2 O 2 S 1 EPI Suite (v 3.20) Molecular weight 180.2 g/mol EPI Suite (v 3.20) SMILES Code n1nc2cccc(C(=O)O)c2s1 EPI Suite (v 3.20) Vapor pressure (20/25°C) 2.73 × 10 - 7 torr EPI Suite (v 3.20) Henry’s Law Constant 3.42 × 10 - 11 atm m 3 mole - 1 EPI Suite (v 3.20) Solubility (20 o C) 225 mg/L MRID 44537042 K oc 138 ml/g (mean) MRID 44537042 Hydrolysis Assumed stable MRID 44014252 Aqueous Photolysis (t 1/2 ) Assumed stable No data Aerobic Aquatic Metabolism (t 1/2 ) 746 days MRID 44537038 Aerobic Soil Metabolism (t 1/2 ) 16.5 days MRID 44014253 Anaerobic Aquatic Metabolism (t 1/2 ) Assumed stable No data
N/A = not a vail able



### 3.4. Clean Water Act

Acibenzolar

- S

- methyl is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 3 

### . In addition, no Total Maximum Daily Loads (TMDL) have been developed 4 

### . The Impaired Waters and Total Maximum Daily Loads website can be consulted for more information 5 

### . The Agency invites submission of water quality data for acibenzolar

- S

- methyl . To the extent possible, data should conform to the quality standar ds in the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process 6 

### , in order to ensure they can be used quantitatively or qualitatively in pesticide risk
assessments.
4. Receptors Consistent with the process described in the Overview Document (USEPA, 2004), the risk assessment for acibenzolar

- S

- methyl relies on a surrogate species approach. Toxicological data generated from surrogate test species, w hich are intended to be representative of broad taxonomic groups, are used to extrapolate the potential effects on a variety of species (receptors) included under these taxonomic groupings.

A cute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature will be used to evaluate the potential direct and indirect effects of acibenzolar

- S

- methyl to aquatic and terrestrial receptors. This includes toxicity on the technical grade active ingredient, degradates, and when available, formulated products ( e.g. , “Six

- Pack” studies). Open literature studies will be identified through EPA’s ECOTOXicology (ECOTOX) database 7 

### , which employs a literature search engine for lo ca ting chemical toxicity data.

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885
4 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES
5 htt p://www.epa.gov/owow/tmdl/
6 http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1

- sop.pdf
7 http://cfpub.epa.gov/ecotox/

### 10 A summary of data representing non

- target organisms exposed to acibenzolar

- S

- methyl in aquatic and terrestrial habitats is provided in Sections 4.1 and 4.2

. Four additional studies (one 850.2100 and three 850.5400) were recen tly received and are in review (see section 6.82 ). A summary of ecological incidents associated with acibenzolar

- S

- methyl is provided in Section 4.3

. Studies submitted by the registrant are listed in Appendix A

. The ECOTOX database will be searched when the risk assessment for acibenzolar

- S

- methyl is prepared. At that time, EFED will review the endpoints from open literature studies that are more sensitive than those from available guideline studies.

4.1. Effects to Aquatic Organisms

Table 3 . Summary of Toxicity of Acibenzolar

- S

- m ethyl (TGAI) to Aquatic Organisms Species Exposure Scenario % AI Toxicity MRID Study Classification/ Acute Toxicity Category Rainbow t rout ( Oncorhynchus mykiss ) 96

- hr, flow

through 98 LC 50 

### = 0.88 (0.68

- 0.95) mg ai/L 1



### NOAEC = 0.43 mg ai/L

LOAEC = 0.68 mg ai/L based on lethargy, erratic swimming , and surfacing

. Discoloration and lying on the bottom were observed at the highest test concentration. 44537013 Acceptable/ Highly toxic

Early

- life stage, flow

through 98 NOAEC = 0.026 mg ai/L LOAEC = 0.054 mg ai/L based on reduced growth (wet and dry weight). 44537019 Acceptable/ Not applicable

Bluegill sunfish ( Lepomis macrochirus ) 96

- hr, flow

through 98 LC 50 

### = 1.6 (1.4

- 1.9) mg ai/L 1


### NOAEC = 0.90 mg ai/L LOAEC = 1.3 mg ai/L based on mortality, lethargy, and surfacing. Discoloration, erratic swimming, and lying on the bottom were observed at the highest test concentration. 44537011 Acceptable/ Moderately toxic

### 11 Species Exposure Scenario % AI Toxicity MRID Study Classification/ Acute Toxicity Category Water flea ( Daphnia
magna ) 48

- hr, flow

through 98 EC 50 

### = 2.9 (2.5

- 3.5) mg ai/L 1


### NOAEC = 0.82 mg ai/L LOAEC = 1.4 mg ai/L based on mortality and lethargy. 2 

### 44537014 Acceptable/ Moderately toxic

Life

- cycle, flow

- through 98 NOAEC = 0.048 mg ai/L LOAEC = 0.087 mg ai/L based on reduced length and dry weight. 44537020 Acceptable/ Not applicable

Sheepshead minnow ( Cyprinodon variegates ) 96

- hr, flow

through 98 LC 50 

### = 1. 6 7 (1.1

- 2.1) mg ai/L 1


### NOAEC = 1.1 mg ai/L LOAEC = 2.1 mg ai/L based on mortality, lethargy, surfacing, and lying on the bottom. 44537016 Acceptable/ Moderately toxic

Eastern oyster ( Crassostrea virginica ) 96

- hr, flow

through 98 EC 50 

### = 0.59 (0.47

- 0.75) mg ai/L 1


### NOAEC = 0.19 mg ai/L LOAEC = 0.34 mg ai/L based on reduced shell growth. 44537017 Acceptable/ Highly toxic

Saltwater mysid ( Americamysis bahia ) 96

- hr, flow

through 98 LC 50 

### = 0.88 (0.74

- 1.04) mg ai/L 1


### NOAEC = 0.37 mg ai/L LOAEC = 0.61 mg ai/L based on mortality and erratic swimming. Lethargy was observed at higher test concentrations. 44537018 Acceptable/ Highly toxic

Green a lga e ( Selenastrum capricornutum ) 96

- hr, initial measured concentration 98 EC 50 

### = 3.3 (2.9

- 3.9) mg ai/L 1


### NOAEC = 1.3 mg ai/L

LOAEC = 2 .6 mg ai/L based on reduced cell density

. 44537030 Acceptable/ Not applicable

1 

### Range is 95% confidence interval
2 

### Some Daphnids were observed floating throughout the test in all test concentrations and the solvent control.

### 12 Table 4 . Summary of Toxicity of CGA

- 210007 to Aquatic Organisms Species Exposure Scenario % AI Toxicity MRID Classification/ Category Rainbow t rout ( Oncorhynchus mykiss ) 96

- hr, static 97 LC 50 

### > 92 mg total ai/L 2


### NOAEC ≥ 92 mg total ai/L

No mortality or sub

lethal effects observed. 44537012 Supplemental/ Not applicable

Water flea ( Daphnia
magna ) 48

- hr, static 97 EC 50 

### = 59.9 (44.9

- 91) mg ai/L 1



### NOAEC = 1 0 .3 mg ai/L

LOAEC = 18 .6 mg ai/L based on mortality

. No sub

- lethal effects observed. 44537015 Supplemental/ Slightly toxic

Green a lga e ( Selenastrum capricornutum ) 72

- hr, mean measured concentration 97 EC 50 

### = 80.1 ( 55

. 7

- 9 7.5 ) mg ai/L 1



### NOAEC = 57.7 mg ai/L

LOAEC = 97.5 mg ai/L based on reduced cell density

. 44537031 Supplemental/ Not applicable

1 

### Range is 95% confidence interval
2 

### Previous risk assessments reported in error that the toxicity was > 100 mg ai/L. Toxicity is reported as “total ai” because precipitate was observed in the test chamber throughout the test and samples were not filtered or centrifuged prior to analysis

. 

### Toxicity of CGA

- 210007 to rainbow trout may be underestimated because precipitate was observed in the test chamber and samples were not filtered or centrifuged prior to analysis. Centrifugation or filtration is required to determine t he amount of CGA

- 210007 that was freely dissolved and bioavailable. However, the available study prov ides enough evidence to reasonably conclude that CGA

- 210007 is likely less toxic than acibenzolar

- S

- methyl to rainbow
trout . The LC 50 

### from the CGA

- 210007 stud y is at least two orders of magnitude higher ( i.e. , less toxic) than the acute LC 50 

### s from the ava ilable acibenzolar

- S

- methyl fish studies; this means that CGA

- 210007 is less toxic than acibenzolar

- S

- methyl as long as > 1 % of the C GA

- 210007 was in solution ( i.e
., dissolved). This is reasonable given that the test concentration was well below the
repor ted solubility limit of CGA

- 210007 (225 mg/L at 20°C). Repeat testing is unlikely to demonstrate that CGA

- 210007 is more toxic than acibenzolar

- S

- methyl.

Available data for the major degradation product, CGA

- 210007, shows that it is less toxic than acibenzolar

- S

- methyl for certain taxonomic groups

. Given the limited toxicity data on CGA

210007, Ecological Structure Activity Relationship (ECOSAR) methods were used to predict the aquatic toxicity of CGA

- 210007 based on stru ctural similarity to chemicals for which aquatic toxicity data are known. ECOSAR predictive software is available publically though the Epi

### 13 SuiteTM program 8 

### . Confidence in the ECOSAR estimates was low because they were more than an order of magnitude grea ter, that is, less toxic, than experimentally derived toxicity values. However, relative comparison of ECOSAR estimates of acibenzolar and CGA

- 210007 suggests that CGA

- 210007 is not more toxic than acibenzolar

- S

- methyl to fish and invertebrates on an
acut e or chronic basis.

4.2. Effects to Terrestrial Organisms

Table 5

. Summary of Toxicity of Acibenzolar

- S

- m ethyl (TGAI) to Terrestrial Organisms Species Exposure Scenario % AI Toxicity MRID Study Classification/ Acute Toxicity Category Bobwhite quail ( Colinus virginianus ) Single oral dose, birds observed for 14 days 97.9 LD 50 

### > 2000 mg/kg

- bw

No effects observed 44537005 Acceptable/ Practically non

- toxic

8 days (5 days treatment and 3 days observation) 97.9 LC 50 

### > 5000 mg/kg

- diet

No effects observed 44537006 Acceptable/ Practically non

- toxic

22 weeks 97.9 NOAEC = 600 mg/kg

diet

LOAEC = 1000 mg/kg

- diet based on reduced 14

- day

- old survivor weights and reduced percentage of 14

- day

- old hatchling survivors. 44537009 Acceptable/ Not applicable

Mallard duck ( Anas platyrhynchos ) Single oral dose, birds observed for 14 days 97.9 LD 50 

### > 2000 mg/kg

- bw

No effects observed 44537004 Acceptable/ Practically non

- toxic

8 days (5 days treatment and 3 days observation) 97.9 LC 50 

### > 5000 mg/kg

- diet

NOAEC = 2450 mg/kg

- diet

LOAEC = 5000 mg/kg

- diet based on reduced body weight gain 44537008 Acceptable/ Practically non

- toxic

23 weeks 97.9 NOAEC ≥ 1000 mg/kg

- diet

LOAEC = N o effects observed. 44537010 Acceptable/ Not applicable

8 http://www.epa.go v/oppt/exposure/pubs/episuite.htm

### 14 Species Exposure Scenario % AI Toxicity MRID Study Classification/ Acute Toxicity Category Laboratory Rat Single oral dose, rats observed for 14 days 98 LD 50 

### > 5000 mg/kg

- bw 44014214 Acceptable/ Practically non

- toxic

2

- generation reproduction study 97.9 NOAEC = 200 mg/kg

diet

LOAEC = 2000 mg/kg

- diet based on parental toxicity ( increased weights and hemosiderosis of the spleen) and developmental toxicity (reduced pup body weight gains and lower pup body weights during lactation). 44014241 Acceptable/ Not applicable

Honey bee ( Apis mellifera ) 48 hours, contact and oral 97.9 Contact LD 50 

### > 100 μg/bee

Oral LD 50 

### > 100 μg/bee 44537033 Acceptable (contact test), Supplemental (oral test)/ Practically non

- toxic

### 15 Table 6 . Summary of Toxicity of Acibenzolar

- S

- m ethyl (Formulations) to Terrestrial Organisms Species Exposure Scenario % AI Toxicity MRID Classification/ Category Terrestrial Plants Tier 1, seedling
emergence, 0.094 lb ai/A of CGA

245704 50 WG 51.2 Monocots EC 25 

### > 0.094 lb ai/A

NO A EC < 0.094 lb ai/A for wheat based on dry weight inhibition

Dicots EC 25 

### > 0.094 lb ai/A

NO A EC < 0.094 lb ai/A for tomato based on shoot height inhibition 44537028 Supplemental / Not applicable

Tier 1, vegetative vigor, 0.094 lb ai/A of CGA

- 245704 50 WG 51.2 Monocots EC 25 

### > 0.094 lb ai/A

NO A EC = 0.094 lb ai/A

Dicots EC 25 

### > 0.094 lb ai/A

NO A EC = 0.094 lb ai/A 44537029 Acceptable/ Not applicable



### 4.3. Incident Databases Review Reviews were conducted of the Ecological Incident Information System (EIIS, version 2.1.1) 9



### , the Agency’s Aggregated Incidents Reports database, and the Avian Incident Monitoring System (AIMS) 10 

### on Augu st 2, 2013. Incidents involving acibenzolar

- S

- methyl were reported in the EIIS database only. Syngenta submitted four incident reports on head lettuce damaged throughout California due to direct application of acibenzolar

- S

- methyl ( Table 7 ). The legality of use for these incidents is “registered use”. The certainty index for these incidents is possible.

The total number of actual incidents associated with the use of acibenzolar

- S

- methyl may be higher than what is reported to the Agency. Incidents may go unreported since effects may not be immediately apparent or readily attributed to the use of a chemical. As such, the absence of incident reports cannot be construed as the absence of incidents.

9 http://www.epa.gov/espp/consultation/ecorisk

- overview.pdf
10 http://www.abcbirds.org/abcprograms/policy/toxins/aims/aims/index.cfm

### 16 Table 7 . Acibenzolar

- S

- m ethyl Incid ent Data from the EIIS Database

Incident ID Date Legality Certainty State (City) Generic Species and (Total Magnitude) Comments

I014597

- 006 3/23/2003 Registered

use Possible CA (Monterey) Lettuce, head (77 acres) Blockade (Actigard 50WG) caused chlorosis (yellowing).

I014597

- 007 3/27/2003 Registered

use Possible CA (Monterey) Lettuce, head (77 acres) Blockade (Actigard 50WG) caused discoloration/bleaching.

I014597

- 008 6/9/2003 Registered

use Possible CA (Santa Cruz) Lettuce, head (108 acres) Blockade (Actigard 50WG) caused chlorosis (yellowing).



### 5. Exposure Pathways of Concern The use patterns and environmental fate properties of a cibenzolar

- S

- methyl indicate that exposure to non

- target aquatic and terrestrial organisms may occur from direct spray and off site
movement via spray drift and runoff

. Screening Imbibition Program

The Screenin g Imbibition Program (SIP v.1.0 ) 11 

### was used to calculate an upper bound estimate of bird and mammal exposure to acibenzolar

- S

- methyl in drinking water. Drinking water exposure alone was determined not to be a potential acute or chronic concern for birds or mammals. Screening of CGA

- 210007 risk will be performed if toxicity data become available. Appendix B provides model results.

Screening Tool for Inhalation Risk

The Screening Tool for Inhalation Risk ( STIR v.1.0 ) 10 

### was used to provide an upper bound estimate of exposure of birds and mammals to pesticides through inhalation of spray drift or vapor. The screening suggests that acibenzolar

- S

- methyl exposure is not likely significant enough for an inhalation risk concern. Appendix C provides model results.

6. Analysis Plan In order to address the risk hypothesis, the potential for adverse effects on the environment is estimated. The use, environmental fate, and ecological effects of acibenzolar

- S

- methyl will be character ized and integrated to assess risk. This will be accomplished using a risk quotient ( RQ; ratio of exposure concentration to effects concentration) approach. Although risk is often defined as the likelihood and magnitude of adverse ecological effects, the risk quotient

- based approach does not provide a quantitative estimate of likelihood or magnitude of an adverse effect. However, as outlined in the Overview Document (USEPA, 2004), the likelihood of effects to individual organisms from particular uses of acibenzolar

- S

- methyl will be estimated

11 http://www.epa.gov/oppefed1/models/terrestrial

### 17 using the probit dose

- response slope and either the level of concern or actual calculated risk quotient value.

This analysis plan will be revisited and may be revised depending upon a full review of the data availabl e in the open literature and the information submitted by the public in response to the opening of the Registration Review docket.

6.1. Stressors of Concern

Ecological Risk Assessment

Acibenzolar

- S

- methyl and CGA

- 210007 will be considered the stressors of concern in the ecological risk assessment

. CGA

- 210007 is a concern given the rapid degradation of acibenzolar

- S

- methyl ( e.g. , t 1/2 

### = 0.025 days in the available aqueous photolysis study), the substantial formation of CGA

- 210007 ( e.g. , formation up to 99% in the available aerobic soil metabolism study), and lack of a complete toxicity dataset. Risk from acibenzolar

- S

- methyl and CGA

- 21007 will be assessed separately when toxicity data is available for both compounds. For
assessment en dpoints without CGA

- 210007 toxicity data, CGA

- 210007 toxicity will be assumed equal to that of acibenzolar

- S

- methyl (given that available information does not indicate greater toxicity of CGA

- 210007 ) and a total toxic residue (TTR) modeling approach will b e used to calculate EECs based on acibenzolar

- S

- methyl plus CGA

- 210007 residues.

CGA

- 210007 toxicity to birds and mammals 12 

### is unknown and will be assumed equal to that of acibenzolar

- S

- methyl in the absence of data. However, there is no basis at this tim e for characterizing a level of confidence in the assumption that CGA

- 210007 is not more toxic than acibenzolar

- S

- methyl to birds and mammals

. Drinking Water Assessment

Acibenzolar

- S

- methyl and CGA

- 210007 will be considered the stressors of concern i n the drinking water assessment consi stent with past DWAs and the conclusions of the Metabolism Assessment Review Committee (MARC) decision memo (11/29/99).

6.2. Measures of Exposure

Acibenzolar

- S

- methyl and CGA

- 210007 concentrations in aquatic and terrestrial environments will be modeled using the maximum labeled application rates, the maximum number of applications, the minimum application intervals, and application methods that have the greatest potential for off

- sit e transport.

12 A rat acute oral LD 50 > 2000 mg/kg is reported in the IUPAC footprint database ( http://sitem.herts.ac.uk/aeru/iupac/688.htm ). This data has not bee n reviewed by the Agency and the toxicity endpoint is presented at face value. This data does not support or reject the assumption that CGA

- 210007 is not more toxic than acibenzolar

- S

- methyl.

### 18 Aquatic Exposure

T ier II models PRZM ( P esticide R oot Z one M odel, v3.12.3; June, 2006) and EXAMS ( EX posure A nalysis M odeling S ystem, version 2.98.04.06, April 2005) in the PE5 shell 13 

### will be used to model estimate d environmental concentrati ons (EECs) of acibenzolar

- S

- methyl and CGA

210007 in surface waters.

Terrestrial Exposure

There is potential for exposure to non

- target organisms through consumption of contaminated food items ( e.g. , treated insects or vegetation), direct applic ation, runoff, or spray drift.

T

- REX (v 1.5) 14 

### will be used to estimate avian and mammal exposure to acibenzolar

- S

- methyl and CGA

- 210007 . For input into T

- REX, the default foliar dissipation half

- life of 35 days will be used in the absence of acceptable foliar d issipation rate data.

TerrPlant (v 1.2 .2) 1 3 

### will be used to calculate EECs for characterizing exposure to terres trial and semi

- aquatic plants.

6 .3. Measures of Effect Toxicity effects data will be used as measures of direct and indirect effects to biolog ical receptors (USEPA, 2004). As discussed previously, data will be obtained from registrant

submitted studies and from literature studies identified in ECOTOX.

Quantitative assessment of risks will be based on study endpoints that can be directly linked to the Agency’s assessment endpoints of impaired survival, growth, and reproduction. Sub

- lethal effects ( e.g. , lethargy and changes in coloration) will be evaluated qualitatively. Available incident data will be used to further characterize risk.

6.4. Integration of Exposure and Effects The exposure and effects data will be integrated in order to evaluate potential adverse ecological effects on non

- target species. The risk quotient method will be used to compare exposure and measured toxicity values. EECs will be divided by acute and chronic toxicity values. The resulting RQs will be compared to the Agency’s Levels of Concern (LOC) (USEPA, 2004).

6.5. Endangered Species Assessments Consistent with the Agency’s responsibility under the Endangered Spe cies Act (ESA), the Agency will evaluate risks to Federally

- listed threatened and endangered (listed) species from registered uses of acibenzolar

- S

- methyl . This assessment will be conducted i n accordance with the Overview Document (USEPA, 2004), provision s of the ESA, and the Services’ Endangered Species Consultation Handbook (USFWS and NMFS, 1998).

13 http://www.epa.gov/oppefed1/models/water
14 http://www.epa.gov /oppefed1/models/terrestrial

### 19 6.6. Endocrine Disruptor Screening As required by Federal Food, Drug and Cosmetic Act (FFDCA) section 408(p), acibenzolar

- S

methyl is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP) 15



### . Acibenzolar

- S

- methyl is not in the first or second group of pesticide active ingredients to be screened under the EDSP.

6.7. Drinking Water Assessment

A DWA will be conducted for acibenzolar

- S

- methyl , if requested by the Health Effects Division (HED)

. Concentrations of the residue in surface waters will be estimated using the Tier II PRZM/EXAMS model and in ground water by the Tier I SCI

- GROW model and Tier II PRZM

GW model 16



### . 6.8. Preliminary Identification of Data Gaps Available studies submitted to fulfill environmental fate and ecological effects guideline requirements, as well as outstanding data gaps for acibenzolar

- S

- methyl are defined in Sections 6.8.1 and 6.8.2 , respect ively. Studies are i dentified that offer data for each guideline requirement, as well as study classifications and whether or not further data are needed in order to support the risk assessment.

6.8.1. Environmental Fate Data Environmental fate data gap s for acibenzolar

- S

- methyl and CGA

- 210007 are indicated in the table below ( Table 8 )

. EFED recommends requesting the following studies :

• Environmental chemistry method ( acibenzolar

- S

- methyl and CGA

- 210007 in water )

• Independent laboratory method ( acibenzolar

- S

- methyl and CGA

- 210007 in water )

Fulfilling the environmental chemistry methods (ECM) and independent laboratory validation (ILV) studies for water sampling is important for monito ring and enforcement purposes.

Anaerobic Soil Metabolism

The anaerobic soil metabolism study remains a data gap, but not one that EFED recommends being fulfilled at this time

. T he anaerobic soil metabolism study would not likely provide information that would greatly change the A gency’s understanding of the enviro nmental risks of acibenzolar

- S

- methyl because sufficient information on the anaerobic metabolism of acibenzolar

- S

- methyl can be obtained from the anaer obic aquatic metabolism study.

15 http://www.epa.gov/endo/
16 http://www.epa.gov/oppefed1/models/water

### 20 T able 8 . Environmental Fate Data and Data Gaps for Acibenzolar

- S

- m ethyl and CGA

210007

Guideline Description MRID Classification Data Gap? Comments

835.2120 Hydrolysis 44014252 A cceptable No 1 Not recommended at this time (see text above).

2 To be determined. Study was recently received and is in review. 835.2240 Photodegradation in
Water 44537034 A cceptable No

835.2410 Soil Photolysis 44537035 S upplemental No

835.2370 Photodegradation in Air N ot R equired No

835.4100 Aerobic Soil Metabolism 44014253 44537036 S upplemental No

835.4200 Anaerobic Soil Metabolism - - Yes 1

835.4300 Aerobic Aquatic Metabolism 44537037 A cceptable No

835.4400 Anaerobic Aquatic Metabolism 44537038 S upplemental No

835.1230 835.1240 Leaching Adsorption/Desorption : Acibenzolar 4 4014254 44537040 44537041 S upplemental A cceptable A cceptable No

CGA

- 210007 44537042 A cceptable No

835.1410 Laboratory Volatility N ot R equired No

835.8100 Field Volatility N ot R equired No

835.6100 Terrestrial Field Dissipation 44537046 44537047 A cceptable No

850.6100 Acibenzolar

– soil ECM
ILV 44537044 44537045 A cceptable No

CGA

- 210007

– soil ECM
ILV 44537048 44537043 In R eview Yes 2

Acibenzolar

– water ECM
ILV - - Yes

CGA

- 210007

– water ECM
ILV - - Yes

850.1730 Accumulation in Fish 44537049 A cceptable No

### 21 6.8 .2. Ecological Effects Data

D ata gaps for acibenzolar

- S

- methyl remain ( Tables 9 , 10 , and 11 ). After review, some studies have been reclassified and no longer meet a given data requirement.

EFED recommends requesting the following studies to refine the risk assessment :

• Terrestrial plant toxicity (TEP; Tier II seedling emergence; wheat and tomato)

• Aquatic vascular plant toxicity (acibenzolar

- S

- methyl; TGAI)

• Avian reproduction (CGA

- 210007; bobwhite quail )

• Larval honeybee acute oral toxicity (acibenzolar

- S

- m ethyl; TGAI)

CGA

- 210007

EFED does not recommend requesting additional aquatic toxicity data for CGA

- 210007 at this time given that available data indicate that it is not more toxic than acibenzolar

- S

- methyl. However, for endpoints without CGA

- 210007 tox icity data , a total toxic residue (TTR) approach will be used and CGA

- 210007 toxicity will be assumed equal to that of acibenzolar

- S

- methyl.

Past risk assessments have not identified a risk concern for birds based on the assumption that CGA

- 210007 and aci benzolar

- S

- methyl are similar in toxicity. Chronic exposure is more likely from CGA

- 210007 given that fate data suggests quick degradation of acibenzolar

- S

- methyl by several pathways. Therefore, there is some uncertainty in the risk conclusions given tha t there would be a risk concern if the degradate is slightly more toxic than acibenzolar

- S

- methyl . For instance, recent risk assessments stated that there would be a chronic risk concern if CGA

210007 is about 2

- 15X more toxic than acibenzolar

- S

- methyl wh ich caused effects to birds in one of the available reproduction studies. On the other hand, chemical structures suggest that CGA

- 210007 is more likely than acibenzolar

- S

- methyl to be excreted in urine. Given the uncertainty, EFED recommends requesting o ne study on chronic toxicity of CGA

- 210007 to birds. CGA

- 210007 data from one study would reduce uncertainty described above and would be used to confirm the assumption that CGA

- 210007 is not more toxic than acibenzolar

- S

methyl. If CGA

- 210007 is more to xic tha n acibenzolar

- S

- methyl, then additional testing may be recommended. A study with bobwhite quail is recommended instead of mallard duck primarily because it was the species showing greater sensitivity in the available chronic studies with acibenzol ar

- S

- methyl. In this case, an acute dose or dietary study with CGA

- 210007 cannot be used to address the uncertainty; it cannot be used to extrapolate to the available chronic data because the available acute studies with acibenzolar

- S

- methyl showed no mor tality which is the basis for comparison. In the absence of data, CGA

- 210007 toxicity will be assumed equal to that of acibenzolar

- S

- methyl and uncertainty in the risk conclusions will be characterized in terms of how much more toxic CGA

- 210007 would need to be compared to acibenzolar

- S

- methyl to trigger a risk concern.

Whole Sediment Acute Toxicity (Freshwater and Marine Invertebrates)

Acute whole sediment studies are a data gap for acibenzolar

- S

- methyl; however, EFED does not recommended requesting data at this time. To have a risk concern, acibenzolar

- S

- methyl would need to be at least three orders of magnitude more toxic to benthic i nvertebrates than to water

### 22 column invertebrates 17 

### . There was not a n acute risk concern for aquatic invertebrates in previous risk assessments; a conclusion that is unlikely to change with submission of additional data. There is not a data gap for CGA

- 2100 07 because it is more mobile than acibenzolar

- S

- methyl and is less likely to accumulate in sediments. Nonetheless, it is worth noting that CGA

- 210007 would need to be at least two orders of magnitude more toxic to benthic invertebrates (compared
to water column invertebrates) for there to be a risk concern 1 7. 

### Studies could be recommended in the future if exposure levels increase ( e.g. , higher labeled rates) or other information suggests that there may be concern for benthic invertebrates.

Table 9 . Ecolo gical Effects Data (TGAI) for Aquatic Organisms Exposed to Acibenzolar

- S

m ethyl and Data Gaps

Guideline Description MRID Classification Data Gap? Comments

850.1075 Acute freshwater fish toxicity (cold water species) 44537013 Acceptable No 1 Toxicity may be estimated using
an acute

- to

- chronic ratio using available daphnid and mysid data.

2 Toxicity may be estimated using
an acute

- to

- chronic ratio using available rainbow trout and sheepshead minnow data.

3 Studies are not recommended at this time as additional data are unlikely to change risk conclusions (see text above).

4 To be determined. Study was recently received and is in review.

5 Solvent effects were observed and the NOAEC is non

- definitive. In the absence of data, toxicity from analogous chemicals may be considered; however, no analogs have been identified at this time. Risk to vascular aquatic plants will be assumed in the abs ence of data. Acute freshwater fish toxicity (warm water species) 44537011 Acceptable No

Acute estuarine/ marine fish toxicity 44537016 Acceptable No

850.1010 Acute toxicity to freshwater invertebrates 44537014 Acceptable No

850.1025 Acute estuarine/ marine mollusk toxicity 44537017 Acceptable No

850.1035 Acute estuarine/ marine invertebrate toxicity 44537018 Acceptable No

850.1300 Freshwater invertebrate life cycle 44537020 Acceptable No

850.1350 Saltwater invertebrate life cycle - - Yes 1

850.1400 Freshwater fish early life stage 44537019 Acceptable No

Saltwater fish early life stage - - Yes 2

850.1735 Whole sediment acute toxicity, freshwater invertebrates - - Yes 3

17 Based on preliminary benthic pore water EECs from aerial use on cucurbits (the Section 3 use with the highest reported EECs in past risk assessments). Aci benzolar

- S

- methyl peak EEC = 0.008 μg/L. CGA

- 210007 peak EEC = 5.25 μg/L

.

### 23 Guideline Description MRID Classification Data Gap? Comments

850.1740 Whole sediment acute toxicity, marine

invertebrates - - Yes 3

850.5400 A Aquatic plant growth (freshwater green alga) 44537030 Acceptable No

Aquatic plant growth (freshwater diatom) 49111303

- Yes 4

Aquatic plant growth

(saltwater diatom) 49111302

- Yes 4

Aquatic plant growth (Cyanobacteria) 49111304

- Yes 4

850.4400 Aquatic plant growth (vascular plants) 44537032 Invalid Yes 5

A As of July 2012 the new guideline numbers are 850.4500 (Algal toxicity) and 850.4550 (Cyanobacteria toxicity )



### T able 1 0 . Ecological Effects Data (TGAI) for Terrestrial Animals Exposed to Acibenzolar

S

- m ethyl and Data Gaps

Guideline Description MRID Classification Data Gap? Comments

850.2100 Avian acute oral toxicity (upland game or waterfowl species) 44537004 44537005 Acceptable Acceptable No 1 To be determined. Study was recently received and is in review.

2 Data requirement fulfilled for acibenzolar

- S

- methyl. Data gap for CGA

- 210007 (see text above)

3 The “White Paper in Support of the Proposed Risk Assessment Process for Bees” A as submitted to
t he FIFRA Scientific Advisory Panel proposes a screening

- level risk assessment process that includes acute contact and oral toxicity tests with adult bees and an acute oral toxicity test with larval bees. Therefore, EFED recommends requesting a larval hone y bee acute oral toxicity test. The study protocol should be submitted to the Agency for review prior to the initiation of the study. Avian acute oral toxicity (passerine species) 49111301 In Review Yes 1

850.2200 Avian dietary toxicity (upland game species) 44537006 Acceptable No

Avian dietary toxicity

(waterfowl species) 44537008 Acceptable No

850.2300 Avian reproduction (upland game species) 44537009 Acceptable No 2

Avian reproduction (waterfowl species) 44537010 Acceptable No

850.3020 Honeybee acute
contact and oral toxicity 44537033 Acceptable (oral study is Supplemental) No

Non

guideline Larval honeybee acute oral toxicity - - Yes 3

A www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2012

- 0543

- 0004

### 24 T able 1 1 . Ecological Effects Data (TEP) for Plants Exposed to Acibenzolar

- S

- m ethyl and Data Gaps

Guideline Description MRID Classification Data Gap? Comments

850.4100

or 850.4225 A Terrestrial plant toxicity (Tier I or Tier II seedling emergence) 44537028 Supplemental Yes 1 1 Tier II testing is triggered for wheat and tomato based on statistically significant effects observed in the Tier I test. EFED prefers that Tier II testing be conducted with the same formulation used in the Tier I test. In the absence of data, toxicity from analogous chemicals may be considered; however, no analogs have been identified at this time. Risk to plants will be assumed in the absence of data. 850.4150

or 850.4250 B Terrestrial plant toxicity (Tier I or Tier

II vegetative vigor) 44537029 Acceptable No

A As of July 2012 the Final Guideline 850.4100 contains both Tier I and Tier II test guidance.
B As of July 2012 the Final Guideline 850.4150 contains both Tier I and Tier II test guidance.



### 7. References

USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington DC. January 23, 2004.

USFWS and NMFS. 1998. Endangered Species Consultation Handbook: Procedures for Conducting Consultation and Conference Activities Under Section 7 of the Endangered Species Act. Final Draft. March 1998.

### 25 

## APPENDIX A. Submitted Environmental Fate and Effects Stud ies

Environmental Fate Studies

MRID Citation

44014252 Adam, D. (1994) Hydrolysis of CGA

- 245704 Under Laboratory Conditions: Lab Project Number: 17/93: 93DA01: PR 17/93. Unpublished study prepared by Ciba

- Geigy Ltd. 82 p.

44014253 Adam, D. (1994) Degradation of CGA

- 245704 in Soil Under Aerobic, Aerobic/Anaerobic, and Sterile/Aerobic Conditions at 20 (degrees) C: Lab Project Number: PR 48/94: 93DA02. Unpublished study prepared by Ciba

- Geigy Ltd. 72 p.

44014254 Keller, A. (1995) Ads orption/Desorption of CGA

- 245704 in Various Soil Types: Lab Project Number: 94AK04. Unpublished study prepared by Ciba

- Geigy Ltd. 80 p.

44537034 Spare, W. (1998) Aqueous Photolysis of (carbon

- 14)

- CGA

- 245704: Lab Project Number: 12228: 112

- 96. Unpublished study prepared by Agrisearch Inc. 729 p.

44537035 Spare, W. (1997) Photodegradation of (Phenyl

- U

- (carbon

- 14))CGA

- 245704 on Soil Under Artificial Sunlight: Lab Project Number: 12229: 111

- 96. Unpublished study prepared by Agrisearch Inc. 555 p.

44537036 Adam, D. (1994) Degradation of CGA

- 245704 in Soil Under Aerobic, Aerobic/Anaerobic and Sterile/Aerobic Conditions at 20(degree centigrade): Amendments to Final Report (MRID #44014253): Lab Project Number: 93DA02: 568

- 93: PR

- 48/94. Unpublished study prepar ed by Novartis Crop Protection AG. 6 p.

44537037 Schwartz, B. (1998) Anaerobic Aquatic Metabolism of (U

- Phenyl

- (carbon

- 14)CGA

- 245704: Lab Project Number: ABR

- 97122: 219

- 96. Unpublished study prepared by Novartis Crop Protection, Inc. 243 p.

44537038 Adam, D. (1995) Degradation and Metabolism of (carbon

- 14)

- CGA

- 245704 in Aerobic Aquatic Systems: Lab Project Number: 94DA01: 487

- 94. Unpublished study prepared by Novartis Crop Protection AG. 82 p.

44537039 Erhardt

- Zabik, S.; Wolt, J. (1996) Design and i nterpretation of herbicide anaerobic aquatic metabolism studies: CGA

- 245704. Weed Technology 10:191

- 201.

44537040 Spare, W. (1997) Laboratory Column Leaching Characteristics of Aged (Phenyl

- U

- (carbon

14)CGA

- 245704 in Six Soil Types: Lab Project Number: 1 2239: 45

- 97. Unpublished study prepared by Agrisearch, Inc. 468 p.

44537041 Spare, W. (1997) Adsorption/Desorption of (carbon

- 14)

- CGA

- 245704 by the Batch Equilibrium Method on Representative Agricultural Soils: Lab Project Number: 12226: 107

- 96. Unpublish ed study prepared by Agrisearch, Inc. 364 p.

44537042 Spare, W. (1996) Adsorption/Desorption of (carbon

- 14)

- CGA

- 210007 by the Batch Equilibrium Method on Representative Agricultural Soils: Lab Project Number: 12227: 108

- 96. Unpublished study prepared by Agrisearch, Inc. 359 p.

### 26 44537044 Formica, G. (1993) Determination of Residues of Parent Compound by High Performance Liquid Chromatography (HPLC): CGA

- 245704: Lab Project Number: 218

- 98: REM 172.04. Unpublished study prepared by Novartis Crop Protection AG. 18 p.

44537046 Jacobson, B.; Balu, K.; Manuli, P. (1998) Terrestrial Field Dissipation of CGA

- 245704

- 50WG with Tomatoes and Bare Soil in California: Lab Project Number: 121

- 96: 242.18: 01

- 9604. Unpublished study prepared by Waterborne Environmental, Inc. Minnesota Valley Testing Labor atory, Inc. 386
p.

44537047 Jacobson, B.; Balu, K.; Manuli, P. (1998) Terrestrial Field Dissipation of CGA

- 245704

- 50WG on Bare Soil in North Carolina: Lab Project Number: 303

- 97: 242. 33: 01

- 9706. Unpublished study prepared by Waterborne Environmental, I nc. and Minnesota Valley Testing Laboratory, Inc. 301 p.

44537048 Formica, G. (1995) Determination of the Metabolite CGA 210007 by High Performance Liquid Chromatography (HPLC): Lab Project Number: REM 172.08: 219

- 98. Unpublished study prepared by Novart is Crop Protection AG. 20 p.

44537049 Clark, A. (1998) Uptake, Depuration, and Bioconcentration of (carbon

- 14)

- CGA

- 245704 in Bluegill Sunfish (Lepomis macrochirus) Under Flow

- Through Test Conditions: Lab Project Number: ABR

- 97035: 277

- 96: 43459. Unp ublished study prepared by Novartis Crop Protection, Inc. 199 p.

44537063 Hayworth, C. (1998) (Carbon 14)

- CGA

- 245704: Uptake and Distribution of Residues in Field Grown Confined Rotational Crops: Lab Project Number: ABR

- 98002: 248

- 96: 436001. Unpublished study prepared by Novartis Crop Protection, Inc. 150 p. {OPPTS 860.1850}



### Effects Studies

MRID Citation
44014207 Johnson, A. (1993) CGA 245704: Acute Oral Toxicity (LD50) to the Mallard Duck: Lab Project Number: CBG 625/931492: 573

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 41 p.

44014208 Johnson, A. (1993) CGA 245704: Acute Oral Toxicity (LD50) to the Bobwhite Quail: Lab Project Number: CBG 624/931489: 572

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 42 p.

44014209 Johnson, A. (1993) CGA 245704: Subacute Dietary Toxicity (LC50) to the Bobwhite Quail: Lab Project Number: CBG 622/931451: 570

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 39 p.

44014210 Johnson, A. (1993) CGA 245704: Subacute Dietary Toxicity (LC50) to the Mallard Duck: Lab Project Number: CBG 623/931450: 571

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 39 p.

44014211 Roberts, C.; Swigert, J. (1996) CGA

- 245704: A 96

- Hour Flow

- Through Acute Toxicity Test with the Bluegill (Lepomis macrochirus): (Final Report): Lab Project Number: 108A

- 176: 148

- 96. Unpublished study prepared by Wildlife International Ltd. 46 p.

44014212 Roberts, C.; Swigert, J. (1996) CGA

- 245704: A 96

- Hour Flow

- Through Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): (Final Report): Lab Project Number: 108A

- 177: 147

- 96. Unpublished study prepared by Wildlife International Ltd. 46 p.

### 27 44014213 Roberts, C.; Swigert, J. (1996) CGA

- 245704: A 48

- Hour Flow

- Thr ough Acute Toxicity Test with the Cladoceran (Daphnia magna): (Final Report): Lab Project Number: 108A

- 175: 149

- 96. Unpublished study prepared by Wildlife International Ltd. 46 p.

44014251 Petto, R. (1994) Laboratory Testing for the Toxicity of CGA 24570 4 to Honey Bees, Apis mellifera L: Lab Project Number: 417003: 574

- 93. Unpublished study prepared by RCC Umweltchemie GmbH & Co. 23 p.

44537004 Johnson, A. (1993) CGA

- 245704: Acute Oral Toxicity (LD50) to the Mallard Duck: Lab Project Number: CBG 625/931 492: 573

- 93: CBG 625. Unpublished study prepared by Huntingdon Research Centre Ltd. 43 p.

44537005 Johnson, A. (1993) Acute Oral Toxicity (LD50) to the Bobwhite Quail with CGA

- 245704: Lab Project Number: CBG 624/931489: 572

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 42 p.

44537006 Johnson, A. (1993) Subacute Dietary Toxicity (LC50) to the Bobwhite Quail with CGA

- 245704: Lab Project Number: CBG 622/931451: 570

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 39 p.

44537008 Johnson, A. (1993) Subacute Dietary Toxicity (LC50) to the Mallard Duck with CGA

- 245704: Lab Project Number: CBG 623/931450: 571

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 39 p.

44537009 Redgrave, V. (1995) Bobwhit e Quail Dietary Reproduction and Tolerance Studies with CGA

245704: Lab Project Number: CBG 621/942676: 595

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 268 p.

44537010 Redgrave, V. (1995) Mallard Duck Dietary Reproduction and Toleran ce Studies with CGA

245704: Lab Project Number: CBG 620/942943: 596

- 93. Unpublished study prepared by Huntingdon Research Centre Ltd. 205 p.

44537011 Roberts, C.; Swigert, J. (1996) CGA

- 245704: A 96

- Hour Flow

- Through Acute Toxicity Test with the Bluegill (Lepomis macrochirus): Lab Project Number: 108A

- 176: 148

- 96. Unpublished study prepared by Wildlife International Ltd. 46 p.

44537012 Rufli, H. (1995) Acute Toxicity Test of CGA

- 210007 Technical (Metabolite of CGA

- 245704) to Rainbow Trout (Oncorhynchus my kiss) in the Static System: Lab Project Number: 943649: 789

- 95. Unpublished study prepared by Ciba

- Geigy Ltd. 28 p.

44537013 Roberts, C.; Swigert, J. (1996) CGA

- 245704: A 96

- Hour Flow

- Through Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss ): Lab Project Number: 108A

- 177: 147

- 96. Unpublished study prepared by Wildlife International Ltd. 46 p.

44537014 Roberts, C.; Swigert, J. (1996) CGA

- 245704: A 48

- Hour Flow

- Through Acute Toxicity Test with the Cladoceran (Daphnia magna): Lab Project Numbe r: 108A

- 175: 149

- 96. Unpublished study prepared by Wildlife International Ltd. 46 p.

44537015 Grade, R. (1994) Report on the Acute Toxicity Test of CGA

- 210007 Technical (Metabolite of CGA

- 245704) on Daphnia (Daphnia magna Straus 1820): Lab Project Number: 943555: 511

- 94. Unpublished study prepared by Ciba

- Geigy Ltd. 27 p.

### 28 44537016 Roberts, C.; Swigert, J. (1996) CGA

- 245704: A 96

- Hour Flow

- Through Acute Toxicity Test with the Sheepshead Minnow (Cyprinodon variegatus): Lab Project Number: 108A

- 178: 152

- 96. Unpublished study prepared by Wildlife International Ltd. 47 p.

44537017 Roberts, C.; Swigert , J. (1996) CGA

- 245704: A 96

- Hour Shell Deposition Test with the Eastern Oyster (Crassostrea virginica): Lab Project Number: 108A

- 180: 151

- 96. Unpublished study prepared by Wildlife International Ltd. 47 p.

44537018 Roberts, C.; Swigert, J. (1996) CGA

- 24 5704: A 96

- Hour Flow

- Through Acute Toxicity Test with the Saltwater Mysid (Mysidopsis bahia): Lab Project Number: 108A

- 179: 150

- 96. Unpublished study prepared by Wildlife International Ltd. 46 p.

44537019 Graves, W.; Mank, M.; Swigert, J. (1997) CGA

- 2457 04: An Early Life

- Stage Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Lab Project Number: 108A

- 186: 154

- 96. Unpublished study prepared by Wildlife International Ltd. 83 p.

44537020 Graves, W.; Mank, M.; Swigert, J. (1996) CGA

- 245704: A Flow

- Through Life

- Cycle Toxicity Test with the Cladoceran (Daphnia magna): Lab Project Number: 108A

- 187: 153

- 96. Unpublished study prepared by Wildlife International Ltd. 64 p.

44537028 Porch, J.; Krueger, H. (1998) CGA

- 245704 50 WG: A Tier I Toxicity Tes t to Determine the Effects of the Test Substance on Seedling Emergence of Ten Species of Plants: Lab Project Number: 108

- 388: 757

- 97.

44537029 Krueger, H.; Porch, J.; Springer, T. (1997) CGA

- 245704 50 WG: A Toxicity Test to Determine the Effects of the Te st Substance on Vegetative Vigor of Ten Species of Plants: Lab Project Number: 108

- 389: 308

- 97. Unpublished study prepared by Wildlife International, Ltd. 132 p. {OPPTS 850.4150}

44537030 Hughes, J.; Alexander, M.; Conder, L. (1997) Effect of CGA

- 245704 o n the Growth and Reproduction of Selenastrum capricornutum: Lab Project Number: 21

- 01

- 1: 367

- 96. Unpublished study prepared by Carolina Ecotox, Inc. 73 p.

44537031 Grade, R. (1995) Report on the Growth Inhibition Test of CGA

- 210007 Technical (Metabolite of CGA

- 245704) to Green Algae (Selenastrum capricornutum): Lab Project Number: 943650: 790

- 95. Unpublished study prepared by Ciba

- Geigy Ltd. 27 p.

44537032 Hughes, J.; Alexander, M.; Conder, L. (1997) Effect of CGA

- 245704 on the Growth and Reproduction o f Lemna gibba: Lab Project Number: 21

- 01

- 2: 368

- 96. Unpublished study prepared by Carolina Ecotox, Inc. 93 p.

44537033 Petto, R. (1994) Laboratory Testing for Toxicity (Acute Contact and Oral LD50) of CGA

- 245704 to Honey Bees, Apis mellifera L: Lab Proje ct Number: 417003: 574

- 93. Unpublished study prepared by RCC Umweltchemie GMBH & Co. 23 p.

### 29 

## APPENDIX B. SIP v.1.0 Inputs and Outputs

Table 1. Inputs Parameter Value Chemical name Acibenzolar Solubility (in water at 25 o C; mg/L) 7.7

Mammalian LD 50 (mg/kg

- bw) 5000 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg

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

Avian LD 50 (mg/kg

- bw) 2000 Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg

- diet) 1000 Bobwhite quail NOAEC (mg/kg

- diet) 600 NOAEC (mg/kg

- diet) for other bird species 0 Body weight (g) of other avian species 0 NOAEC (mg/kg

- diet) for 2nd other bird species 0 Body weight (g) of 2nd other avian species 0

Table 2. Mammalian Results Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 1.3244 1.3244 Adjusted toxicity value (mg/kg

- bw) 3845.8028 7.6916 Ratio of exposure to toxicity 0.0003 0.1722

Conclusion* Drinking water exposure alone is NOT a potential

concern for mammals Drinking water exposure alone is NOT a potential

concern for mammals

Table 3. Avian Results Parameter Acute Chronic Upper bound exposure (mg/kg

- bw) 6.2370 6.2370 Adjusted toxicity value (mg/kg

- bw) 1440.8590 49.6126 Ratio of exposure to acute toxicity 0.0043 0.1257

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

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

- target animals.

### 30 

## APPENDIX C. STIR v.1.0 Inputs and Outputs

Input Application and Chemical Information
Enter Chemical Name Acibenzolar Enter Chemical Use Outdoor Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air Enter Chemical Molecular Weight (g/mole) 210.3 Enter Chemical Vapor Pressure (mmHg) 3.50E

- 06 Enter Application Rate (lb a.i./acre) 0.0625

Toxicity Properties
**Bird** Enter Lowest Bird Oral LD 50 (mg/kg bw) 2000 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178 **Mammal**
Enter Lowest Rat Oral LD 50 (mg/kg bw) 5000 Enter Lowest Rat Inhalation LC 50 (mg/L) 5.02 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35



### Output Results Avian (0.020 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 3.96E

- 02 Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 4.98E

- 03

Adjusted Inhalation LD 50 1.12E+0 1

Ratio of Vapor Dose to Adjusted Inhalation LD 50 4.45E

- 04 Exposure not Likely Significant Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 6.00E

- 03

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 5.36E

- 04 Exposure not Likely Significant

Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 3.96E

- 02 Maximum 1

- hour Vapor Inhalation Dose (mg/kg) 6.26E

- 03

Adjusted Inhalation LD 50 2.99E+0 2

Ratio of Vapor Dose to Adjusted Inhalation LD 50 2.09E

- 05 Exposure not Likely Significant Maximum Post

- treatment Spray Inhalation Dose (mg/kg) 7.55E

- 03

Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 2.53E

- 05 Exposure not Likely Significant

### 31 

## APPENDIX D . Chemical Names, Structures, and Maximum Reported Degradate Production in Environmental Fate Studies

Table D

- 1 . Chemical Names and Structures of Acibenzolar and its Degradates

Chemical Name Structure

Acibenzolar ( CGA

- 245704 )

IUPAC name: S

- methyl benzo[1,2,3]thiadiazole

- 7

- carbothioate

CAS name: S

- methyl 1,2,3

- benzothiadiazole

- 7

- carbothioate

CGA

- 176315

IUPAC Name: Benzo[1,2,3Jthiadiazole

- 7

- carboxylic acid, methyl ester

CGA

- 21 0007

CAS name: benzo[1,2,3]thiadiazole

- 7

- carboxylic acid

CGA

- 206485

IUPAC name: Benzo[1,2,3]thiadiazole

CGA

- 307970

CAS name: Thianthrene 

### N N S S CH 3 

### O



### N N S O CH 3 

### O

N N S OH 

### O

N N S



### S S

### 32 Chemical Name Structure

CGA

- 323060

CGA

- 324041

CGA

- 337304

IUPAC Name: 1 ,1

- Dioxo

- 3

- oxy

- 1H

- 1 λ 6

- benzo [1,2,3]thiadiazole

- 7

- carboxylic acid

CGA

- 379019

A5 

### N N S OH 

### O

OH



### N N S OH 

### O

HO



### N N S OH 

### O

O O

O



### S OH 

### O

O



### O

O S O O

O C C

O SO 2 

### NH 2

### 33 Chemical Name Structure

A7

A8

A14 (Dimer)



### Table D

- 2

. Maximum Reported Amounts of Acibenzolar Degradation Products

. Degradate Maximum % of Applied ( ppm in Field Studies) Study Type MRID CGA

- 176315 Laboratory studies
Irradiated non

- sterile @ 25  ̊ C 8.2% (15 d) Control non

- sterile @ 25  ̊ C 4.9% (0.25 d) Irradiated sterile @ 25  ̊ C 7.3% (15 d) Control sterile @ 25  ̊ C 3.9% (14 d) Soil Photolysis 44537035

Water Fraction @ 25  ̊ C 2.3% (7 d) Sediment Fraction @ 25  ̊ C 2% (7 d) Total System @ 25  ̊ C 2.49% (7 d) Anaerobic Aquatic Metabolism 44537037

MS Loam aged 2.3 h @ 25  ̊ C 3.1% (treated layer) GA sandy loam aged 53.5 h @ 25  ̊ C 0.8% (treated layer) NC sandy clay loam aged 1 h @ 25  ̊ C 0.2% (treated layer) Switzerland loam aged 2.7 min. @ 25  ̊ C 0% (N.A.) MD loamy sand aged 2.2 h @ 25  ̊ C 1.1% (treated layer) CA sandy loam aged 19.5 h @ 25  ̊ C 0.6% (treated layer) Aged Soil Column Leaching 44537040

<DL (uptake day 28 fillet from 16ppb treatment) <DL (uptake day 28 viscera from 16ppb treatment) 0.02ppm (uptake day 28 fillet from 156ppb treatment) 0.03ppm (uptake day 28 viscera from 156ppb treatment) Bioaccumulation in Fish 44537049

CGA

- 210007 Laboratory studies pH 1.17 @ 24  ̊ C 44.84% (23 d) pH 1.17 @ 50  ̊ C 58.01% (23 d) pH 1.33 @ 70  ̊ C 96.27% (30 d) pH 5.12 @ 24  ̊ C 4.52% (30 d) pH 5.23 @ 50  ̊ C 42.92% (30 d) Abiotic Hydrolysis 44014252 

### OH

O C C S O

O NH 2



### C C C S O

O NH 2 

### O

O
C SO 2 

### NH 2 

### C HO 2 

### C

H



### N N
S

S

O N
N S S O

### 34 Degradate Maximum % of Applied ( ppm in Field Studies) Study Type MRID pH 5.39 @ 70  ̊ C 108.32% (28 d) pH 7.17 @ 24  ̊ C 35.38% (30 d) pH 7.30 @ 50  ̊ C 93.97% (30 d) pH 7.30 @ 70  ̊ C 78.32% (0.31 d) pH 9.15 @ 24.2  ̊ C 41.27% (0.26 d) pH 9.02 @ 50  ̊ C 87.68% (0.087 d) pH 9.16 @ 70  ̊ C 104.2% (0.031 d) pH 13 @ 24  ̊ C 101.61% (0.01 d) Irradiated pH 5 @ 25  ̊ C 0.9% (3 d) Control pH 5 @ 25  ̊ C 8.4% (30 d) Aqueous Photolysis 44537034

Irradiated non

- sterile @ 25  ̊ C 65.4% (5 d) Control non

- sterile @ 25  ̊ C 107% (14 d) Irradiated sterile @ 25  ̊ C 25.7% (15 d) Control sterile @ 25  ̊ C 52.1% (30 d) Soil Photolysis 44537035

MS Loam @ 25  ̊ C 85.5% (3 d) GA sandy loam @ 25  ̊ C 58.4% (8 d) NC sandy clay loam @ 25  ̊ C 92.7% (1 d) Switzerland loam @ 25  ̊ C 91.1% (1 d) MD loamy sand @ 25  ̊ C 89.1% (1 d) CA sandy loam @ 25  ̊ C 71.5% (3 d) Aerobic Soil Metabolism 44537040

Aerobic non

- sterile @ 20  ̊ C 82.57% (1 d) Anaerobic non

- sterile @ 20  ̊ C Little change Aerobic sterile @ 20  ̊ C 8.74% (90 d) Aerobic/anaerobic Soil Metabolism 44014253

Water Fraction @ 25  ̊ C 70.87% (272 d) Sediment Fraction @ 25  ̊ C 23.88% (14 d) Total System @ 25  ̊ C 92.65% (360 d) Anaerobic Aquatic Metabolism 44537037

River Water @ 20  ̊ C 75.1% (3 d) River Sediment @ 20  ̊ C 35.26% (59 d) River Total System @ 20  ̊ C 95.74% (7 d) Pond Water @ 20  ̊ C 68.53% (3 d) Pond Sediment @ 20  ̊ C 38.18% (59 d) Pond Total System @ 20  ̊ C 93.39% (7 d) Aerobic Aquatic Metabolism 44537038

MS Loam aged 2.3 h @ 25  ̊ C 26.8% (leachate) GA sandy loam aged 53.5 h @ 25  ̊ C 16.8% (treated layer) NC sandy clay loam aged 1 h @ 25  ̊ C 77.4% (leachate) Switzerland loam aged 2.7 min. @ 25  ̊ C 82.6% (leachate) MD loamy sand aged 2.2 h @ 25  ̊ C 47.7% (leachate) CA sandy loam aged 19.5 h @ 25  ̊ C 19.1% (treated layer) Aged Soil Column Leaching 44537040

0.04ppm (uptake day 28 fillet from 16ppb treatment) 0.31ppm (uptake day 28 viscera from 16ppb treatment) 0.61ppm (uptake day 28 fillet from 156ppb treatment) 3.25ppm (uptake day 28 viscera from 156ppb treatment) Bioaccumulation in Fish 44537049

Terrestrial field dissipation studies Bare ground sandy clay loam soil

– 0.099ppm (5 d after last

treatment) Tomato in sandy clay loam soil

– 0.081ppm (5 d after last

treatment) Terrestrial field dissipation 44537046

Bare ground sandy loam soil

– 0.042ppm (6 h after last treatment) Terrestrial field dissipation 44537047

CGA

- 206485 Laboratory studies

### 35 Degradate Maximum % of Applied ( ppm in Field Studies) Study Type MRID Irradiated non

- sterile @ 25  ̊ C Not detected Control non

- sterile @ 25  ̊ C Not detected Irradiated sterile @ 25  ̊ C 1.8% (7 d) Control sterile @ 25  ̊ C 1.5% (30 d) Soil Photolysis 44537035

CGA

- 307970 Laboratory studies Irradiated pH 5 @ 25  ̊ C 0.9% (3 d) Control pH 5 @ 25  ̊ C 1.2% (30 d) Aqueous Photolysis 44537034

Irradiated non

- sterile @ 25  ̊ C 3.6% (3.5 d) Control non

- sterile @ 25  ̊ C 0.8% (0.25 d) Irradiated sterile @ 25  ̊ C 4.5% (0.5 d) Control sterile @ 25  ̊ C Not detected Soil Photolysis 44537035

CA sandy loam @ 25  ̊ C 0.6% (0 d

– impurity) Aerobic Soil Metabolism 44537040
MS Loam aged 2.3 h @ 25  ̊ C 0.6% (treated layer) GA sandy loam aged 53.5 h @ 25  ̊ C 0.5% (treated layer) NC sandy clay loam aged 1 h @ 25  ̊ C 0.2% (treated layer) Switzerland loam aged 2.7 min. @ 25  ̊ C 0.2% (treated layer) MD loamy sand aged 2.2 h @ 25  ̊ C 0.3% (treated layer) CA sandy loam aged 19.5 h @ 25  ̊ C 0.4% (treated layer) Aged Soil Column Leaching 44537040

CGA

323060/324041 Laboratory studies
Irradiated non

- sterile @ 25  ̊ C 0.9% (10 d) Control non

- sterile @ 25  ̊ C Not detected Irradiated sterile @ 25  ̊ C 1.7% (7 d) Control sterile @ 25  ̊ C Not detected Soil Photolysis 44537035

CGA

- 323060 Alone Laboratory studies
Water Fraction @ 25  ̊ C Not detected Sediment Fraction @ 25  ̊ C 0.34% (360 d) Total System @ 25  ̊ C 0.34% (360 d) Anaerobic Aquatic Metabolism 44537037

CGA

- 324041 Alone Laboratory studies
Water Fraction @ 25  ̊ C Not detected Sediment Fraction @ 25  ̊ C 0.24% (62 d) Total System @ 25  ̊ C 0.24% (62 d) Anaerobic Aquatic Metabolism 44537037

CGA

- 337304 Laboratory studies Irradiated pH 5 @ 25  ̊ C 1.0% (3 d) Control pH 5 @ 25  ̊ C 1.1% (10 d) Aqueous Photolysis 44537034

CGA

- 379019 Laboratory studies
Water Fraction @ 25  ̊ C 1.35 % (360 d) Sediment Fraction @ 25  ̊ C 0.6% (187 d) Total System @ 25  ̊ C 1.56% (130 d) Anaerobic Aquatic Metabolism 44537037

A5 Laboratory studies Irradiated pH 5 @ 25  ̊ C 6.6% (0.083 d) Control pH 5 @ 25  ̊ C Not detected Aqueous Photolysis 44537034

A7 Laboratory studies Irradiated pH 5 @ 25  ̊ C 38.5% (0.17 d) Control pH 5 @ 25  ̊ C Not detected Aqueous Photolysis 44537034

A8 Laboratory studies Irradiated pH 5 @ 25  ̊ C 42.2% (0.5 d) Control pH 5 @ 25  ̊ C Not detected Aqueous Photolysis 44537034

A14 Laboratory studies

### 36 Degradate Maximum % of Applied ( ppm in Field Studies) Study Type MRID Irradiated pH 5 @ 25  ̊ C 9.3% (0.041 d) Control pH 5 @ 25  ̊ C Not detected Aqueous Photolysis 44537034

Non

extractable Residues Laboratory studies
Irradiated non

- sterile @ 25  ̊ C 11.9% (7 d) Control non

- sterile @ 25  ̊ C 4.5% (0.25 d) Irradiated sterile @ 25  ̊ C 9.9% (0.25 d) Control sterile @ 25  ̊ C 3.3% (0.25 d) Soil Photolysis 44537035

Aerobic non

- sterile @ 20  ̊ C 59.75% (90 d) Anaerobic non

- sterile @ 20  ̊ C Little change Aerobic sterile @ 20  ̊ C 7.92% (90 d) Aerobic/anaerobic Soil Metabolism 44014253

Total System @ 25  ̊ C 11.81% (130 d) Anaerobic Aquatic Metabolism 44537037
River System @ 20  ̊ C 26.39% (363 d) Pond System @ 20  ̊ C 36.19% (350 d) Aerobic Aquatic Metabolism 44537038

MS Loam @ 25  ̊ C 10.5% (1 d) GA sandy loam @ 25  ̊ C 6.8% (8 d) NC sandy clay loam @ 25  ̊ C 8.9% (3 d) Switzerland loam @ 25  ̊ C 11.6% (3 d) MD loamy sand @ 25  ̊ C 6.1% (6 h) CA sandy loam @ 25  ̊ C 6.3% (3 d) Aerobic Soil Metabolism 44537040

MS Loam aged 2.3 h @ 25  ̊ C 3.3% (treated layer) GA sandy loam aged 53.5 h @ 25  ̊ C 6.7% (treated layer) NC sandy clay loam aged 1 h @ 25  ̊ C 4.3% (treated layer) Switzerland loam aged 2.7 min. @ 25  ̊ C 3.7% (treated layer) MD loamy sand aged 2.2 h @ 25  ̊ C 1.9% (treated layer) CA sandy loam aged 19.5 h @ 25  ̊ C 8.1% (treated layer) Aged Soil Column Leaching 44537040

Carbon Dioxide Laboratory studies Irradiated pH 5 @ 25  ̊ C 34.2% (15 d) Control pH 5 @ 25  ̊ C Analysis not performed Aqueous Photolysis 44537034

Irradiated non

- sterile @ 25  ̊ C 3.1% (10 d) Control non

- sterile @ 25  ̊ C 3.2% (20 d) Irradiated sterile @ 25  ̊ C Not detected Control sterile @ 25  ̊ C Not detected Soil Photolysis 44537035

Aerobic non

- sterile @ 20  ̊ C 39.37% (360 d) Anaerobic non

- sterile @ 20  ̊ C Little change Aerobic sterile @ 20  ̊ C 3.95% (28 d) Aerobic/anaerobic Soil Metabolism 44014253

Total System @ 25  ̊ C 1.36% (130 d) Anaerobic Aquatic Metabolism 44537037
River System @ 20  ̊ C 9.5% (363 d) Pond System @ 20  ̊ C 9.6% (350 d) Aerobic Aquatic Metabolism 44537038

MS Loam @ 25  ̊ C 1.0% (3 d) GA sandy loam @ 25  ̊ C 1.2% (8 d) NC sandy clay loam @ 25  ̊ C 1.0% (3 d) Switzerland loam @ 25  ̊ C 1.7% (3 d) MD loamy sand @ 25  ̊ C 1.5% (3 d) CA sandy loam @ 25  ̊ C 1.0% (3 d) Aerobic Soil Metabolism 44537040



### m in. = m inutes; d = days; h = hours.