### Fluopy

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Page **1** of **87** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460 **OFFICE OF CHEMICA** **L SA FETY**  **AND POLLUTION PREVENTION**  

### MEMORANDUM **D ATE**  **:** December 22 , 201 5 **SUBJECT: Fluopyram:**  Human Health Risk Assessment for Proposed New Use s on Crop

Subgroup 1B, Subgroup 1C, Crop Group 2, Subgroup 3
- 07A, Subgroup 3
- 07B, Subgroup 4A, Subgroup 4B, Subgroup 5A, Subgroup 5B, Subgroup 6A, Subgroup 6B, Dried Beans , Soy bean, Subgroup 8
- 10A, Subgroup 8
- 10B, Subgroup 9A, Subgroup 9B, Subgroup 10
- 10, Group 11
- 10, Subgroup 12
- 12A, Subgroup 12
- 12B, Subgroup 12
- 12C, Subgroup 13
- 07A, Subgroup 13
- 07B, Subgroup 13
- 07F, Subgroup 13
- 07G, Crop Group 15 (except corn and Rice), Crop Group 16, Subgroup 19A, Dill See d, Subgroup 20A, Subgroup 20B, Subgroup 20C, Artichoke (Globe), Hops, and Sugarcane (Rotated). Amended Tolerance Requests for the Registered Uses due to Crop Group/Subgroup Expansion Requests
. Proposed New U se s on Turf Grass, Ornamentals, and Christmas Trees , and as a S eed Treatment to P eanuts. **PC Code:** 080302 **DP Barcode:** D 4 21926 **Decision No.:** 4 9 2321 **Registration No s**  **. :**  432
- RLGI; 432
- RLGT; 432
- RLGA; 432
- RLGL; 432
- RLGU; 264
- 1078; 264
- 1084; 264
- 1085; 264
- 1090; 264
- 1091 **Petition No .:**  4 F 8 284 **Regulatory Action:**  Section 3 Registration **Risk A**  **ss essment Typ**  **e :**  Single Chemical/Aggregate **Case No.:** NA **T XR No.:**  NA **CAS No.:** 658066
- 35
- 4 **MRID No.:** NA **40 CFR: §**  180. 661 

### FROM: Barry

O’Keefe, Senior Biologist/Risk Assessor Meheret Neguss i e , Chemist Whang Phang, Senior Toxicologist Risk Assessment Branch III Health Effects Division (7509P) **THROUGH:** Chris tine Olinger , Chief

Risk Assessment Branch III Health Effects Division (7509P) **TO:** Tamue Gibson , Risk Manager

Shaja Joy ner, Team Leader Fungicide Herbicide Branch Registration Division (7505P)

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Page **2** of **87** The registrant, Bayer CropScience , is requesting new uses of fluop yr am on artichoke (globe), Brassica (cole) leafy

vegetables, Brassica (cole) leafy vegetables head and stem subgroup, bulb vegetables, canola, carrot, cereal grains (except rice), citrus, corn (including field, sweet, popcorn, and field corn grown for seed) , cotton, cucurbit vegetables, fruiting vegetables, ginseng, grapes and other small vines fruits (except fuzzy kiwifruit), herbs and spices ( except black pepper), hops, leafy

vegetables, legume vegetables (including soy bean), peanut, pome fruits, potato and other root, tuberous and corm vegetables, small berries (caneberries and bushberries), stone fruit, strawberry

and other low growing berrie s, sugar beet, sunflower subgroup, tree nuts ; use as a seed treatment to peanuts ; turf grass (g olf c ourses, s od f arms, sports f

ields, residential, industrial, municipal, c ommercial, and other turf grass areas ), ornamentals ( in residential and c ommercial settings), and Christmas trees. The Registration Division (RD) of OPP has requested that the Health Effects Division (HED) evaluate the hazard and exposure data and conduct dietary , aggregate, occupational and residential exposure assessments, as needed , to estimate the risk to human health that will result from the proposed uses of fluopy ram . This memorandum serves as HED’s assessment of those exposure s. The toxicology

reevaluation was performed by Whang Phang , the drinking water assessment was cond ucted b y Mohammed Ruhman (EPA Environmental Fate and Effects Division (EFED)), the review of the residue chemistry data and the dietary

exposure assessment were conducted by Meheret Neguss i e , and the occupational and residential exposure assessment and aggregate human health risk assessment w ere conducted b y Barry O’Keefe.

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Page **3** of **87 TABLE OF CONTENTS**  **1.0 Executive Summary** 
................................ ................................ ................................ ........... 5 **2.0 HED Recommendations** 
................................ ................................ ................................ .... 9 **2.1 Da** **ta Deficiencies**
................................ ................................ ................................ ............ 9 **2.2 Tolerance Considerations** 
................................ ................................ .............................. 9 **2.2.1 Enforcement Analytical Method** 
................................ ................................ ............... 9 **2.2.2 International Harmonization** 
................................ ................................ ................... 10 **2.2.3 Recommended Tolerances** 
................................ ................................ ....................... 10 **2.2.4 Revisions to Petitioned**  **- For Tolerances** 
................................ ................................ .. 16 **2.3 Label Recommendations** 
................................ ................................ .............................. 17 **3.0 Introduction** 
................................ ................................ ................................ ...................... 18 **3.1 Chemical Identity** 
................................ ................................ ................................ ......... 19 **3.2 Physical/Chemical Characteristics** 
................................ ................................ ............. 19 **3.3 Pesticide Use Pattern** 
................................ ................................ ................................ .... 19 **3.4 Anticipated Exposure Pathways** 
................................ ................................ ................. 38 **3.5 Consideration of Environmental Justice** 
................................ ................................ .... 38 **4.0 Hazard Characterization and Dose**  **- Response Assessment** 
................................ .......... 38 **4.1 Toxicological Effects** 
................................ ................................ ................................ .... 39 **4.2 Safety Factor for Infants and Children (FQPA Safety Factor)** 
............................... 40 **4.2.1 Completeness of the Toxicology Database** 
................................ .............................. 40 **4.2.2 Evidence of Neurotoxicity** 
................................ ................................ ........................ 40 **4.2.3 Evidence of Sensitivity/Susceptibility in the Developing or Young**  **Animal**
........ 40 **4.2.4 Residual Uncertainty in the Exposure Database** 
................................ ................... 40 **4.3 Toxicity Endpoint and Point of Departure Selections** 
................................ .............. 41 **4.3.1 Do**  **se -**  **Response Assessment**
................................ ................................ ...................... 41 **4.3.2 Recommendation for Combining Routes of Exposures for Risk Assessment** 
..... 41 **4.3.3 Cancer Classification and Risk Assessment Recommendation** 
............................ 42 **4.3.4 Summary of Points of Departure and Toxicity Endpoints Used in Human Risk**  **Assessment**
................................ ................................ ................................ ............................... 42 **5.1 Residues of Concern Summary and Rationale** 
................................ .......................... 44 **5.2 Food Residue Profile** 
................................ ................................ ................................ .... 45 **5.3 Water Residue Profile** 
................................ ................................ ................................ .. 45 **5.4 Dietary Risk Assessment** 
................................ ................................ .............................. 46 **5.4.1 Description of Residue Data Used in Dietary Assessment** 
................................ .... 46 **5.4.2 Percent Crop Treated Used in Dietary Assessment** 
................................ .............. 46 **5.4.3 Acute Dietary Risk Assessment** 
................................ ................................ ............... 47 **5.4.4 Chronic Dietary Risk Assessment** 
................................ ................................ ........... 47 **5.4.5 Cancer Dietary Risk Assessment** 
................................ ................................ ............. 47 **5.4.6 Summary Table** 
................................ ................................ ................................ ......... 47 **6.0 Residential (Non**  **- Occupational) Exposure/Risk Characterization** 
............................. 48 **6.1 Residential Handler Exposure** 
................................ ................................ .................... 48 **6.2 Residential Post** **- application Exposure** 
................................ ................................ ....... 48 **6.3 Residential Risk Estimates for Use in Aggregate Assessment** 
................................ .. 49 **6.4 Residential Bystander Post**  **- application**  **Inhalation Exposure**
................................ . 50 **6.5 Non**  **- Occupational Spray Drift Exposure and Risk Estimates** 
................................ . 50

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Page **4** of **87 7.0**  **Aggregate Exposure/Risk Characterization**
................................ ................................ .. 51 **7.1 Acute Aggregate Risk** 
................................ ................................ ................................ ... 51 **7.2 Short** **- Term Aggregate Risk** 
................................ ................................ ........................ 51 **7.3 Chronic Aggregate Risk** 
................................ ................................ .............................. 51 **8. 0**  **Cumulative Exposure/Risk Characterization**
................................ ............................... 52 **9.0 Occupational Exposure/Risk Characterization** 
................................ ............................ 52 **9.1 Short** **- /Intermediate**  **- Term Handler Risk** 
................................ ................................ ... 52 **9.2 Short** **- /Intermediate**  **- Term Post** **- Application Risk** 
................................ .................... 53 **9.2.2 Inhalation Post** **- application Risk** 
................................ ................................ ............. 56 **10.0 References** 
................................ ................................ ................................ ......................... 58 **Appendix A. Toxicology Profile**
................................ ................................ ................................ 60 **A.1 Toxicology Data Requirements** 
................................ ................................ ................... 60 **A.2 Toxicity Profiles** 
................................ ................................ ................................ ............ 61 **Appendix B. Physical/Chemical Properties**
................................ ................................ ............. 72 **Appendix C. Review of Human Research**
................................ ................................ ................ 73 **Appendix D. Residential Handler and Post -**  **application Exposure and Risk Es timates** 
..... 74 **Appendix E. Occupational Handler and Post -**  **application Exposure/Risk Summary Tables**

................................ ................................ ................................ ................................ ....................... 76 **Appendix F. International Residue Limit Status Sheet**
................................ .......................... 84

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Page **5** of **87 1.**  **0 Executive Summary**  Fluopy ram, ( N
- [2
- [3
- chloro
- 5
- (trifluoromethyl)
- 2
-py ridinyl]ethyl]
- 2
- (trifluoromethyl )benzamide) is a broad
- spectrum systemic fungicide of the py ridinyl ethylbenzamide group. It acts by inhibiting succinate dehydrogenase in the cell respiration of fungi. The mechanism of toxicity in mammals is not clearl y defined
. Use Profile The registrant, Baye r CropScience (BCS) , is requesting numerous new uses on agricultural fie ld crops and crop groups be added to the Luna ® 

### Privilege label (4.16 lb ai/gal) [EPA Reg. No. 264
- 1078] that contains the sole active ingredient (ai) fluopy ram . Additionally , BCS is requesting to add numerous agricultural field crops and crop groups to th e following multi
- active ingredient labels: 1) Propulse TM 

### (1.67 lb ai/gal) [EPA Reg. No. 264
- 1084] which contains fluopy ram and prothioconazole; 2) Luna ® 

### Tranquility (1.04 lb ai/gal) [EPA Reg. No. 264
- 1085] which contains fluopy ram and py

rimethanil; 3) Lun a ® 

### Sensation (2.1 lb ai/gal) [EPA Reg. No. 264
- 1090] which contains fluopy

ram and trifloxystrobin; and 4 ) Luna® 

### Experience (1.67 lb ai/gal) [EPA Reg. No. 264
- 1091] which contains fluopy ram and tebuconazole. BCS has proposed to establish tolerances on th e vast majority of crops. Furthermore, BCS has requested tolerance amendments as a result of expanding uses from representative commodities to crop groups/subgroups, addition of new uses, and tolerance re
- assessment. The petitioner additionally

submitted data from field trials conducted in Europe with a variety of crops, which included data from studies conducted in greenhouses to support greenhouse uses in North America. Most proposed applications are at a seasonal rate of 0.445 lb a.i./acre with variou s pre harvest intervals (PHIs). BCS is proposing new use patterns: foliar; banded; soil/in
- furrow; and chemigation/drip irrigation treatments. Additionally, for registered potato (foliar), cotton (seed and soil/in
- furrow treatment) and so yb ean (seed treatment) new uses, a combination of seed/soil/in
- furrow and foliar treatments are requested. Additionally , new rotational crop data for sugarcane have been submitted to support a 14
- day plantback interval (PBI) in Region 3. The database is adequate to support the proposals. In additio n, BCS is requesting a new seed treatment use on peanut seeds to be added to the Luna ® 

### Privilege label (4.16 lb ai/gal) [EPA Reg. No. 264
- 1078]. BCS , is also requesting new non
- food uses of fluopy ram on several newl y proposed labels, including turf grass (golf courses, sod farms, sports fields, residential, industrial, municipal, commercial, and other turf grass areas), ornamentals (in residential and commercial landscapes, interiorscapes, field grown and container ornamentals, in nurseries, and greenhous es, lathhouses, shadehouses, containers and other enclosed structures), fruit and nut trees (including citrus, grapes, pome fruits, stone fruits, and tree nuts), ornamental sunflower, and Christmas trees. The proposed labels are as follows: 1) Fluopy ram 5 00 SC (4.16 lb ai/gal) [EPA File Sy mbol 432
- RLGI ] which contains fluopy ram; 2) FLU+TFS SC 500 (2.1 lb ai/gal) [EPA File Sy mbol 432
- RLGT] which contains fluopy ram and trifloxystrobin; 3) FLU+TFS SC 32.5 (0.104 lb ai/gal)

### Fluopy

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Page **6** of **87** [EPA File Sy

mbol 432
- RL GA] which contains fluopy ram and trifloxystrobin; 4) FLU+TFS SC 25 (0.104 lb ai/gal) [EPA File Sy mbol 432
- RL GL] which contains fluopy ram and trifloxystrobin; and 5) 13ESP715 3.3 SC (3.34 lb ai/gal) [EPA File S ymbol 432
- RLUG] which contains fluopy

ram. Most of the proposed labels require occupational handlers to wear the following personal protective equipment (PPE): long sleeved shirts, long pants, shoes, socks, and chemical resistant gloves. However, the FLU+TFS SC 32.5 and FLU+TFS SC 25 labels do not require the us e of gloves. Additionall y, the Luna ® 

### Privilege label requires water proof gloves for seed treatment activities and no gloves for baggers and bag sewers. On all registered and proposed labels the restricted entry interval (REI) is 12 hours. Fluopy ram is currentl y registered on a variety of agricultural food crops, including apple, cherry (sweet and tart), cotton, dried beans, peanut, potato, strawberry , sugar beets, tree nuts, watermelon, viniferous variety grapes, and for seed treatment to c otton and soy bean. There are no existing residential uses of fluop yram. Exposure Profile The proposed uses of fluopy ram would result in exposures from both food and drinking water
. There is a potential for short
- and intermediate
- term occupational dermal and inhalation exposure to fluopy ram during handling tasks (mixing, loading, and application) and during post
application activities. Long - term occupational exposure is not expected for the proposed use patterns associated with fluopy ram. There is a po tential for residential short
- term dermal and inhalation exposure to fluopy ram to adults during handling tasks. During residential post
application activities there is a potential for short
- term dermal exposure to adults, youths, and children and incident al oral exposure to children 1 to <2 years old. H azard Characterization The l iver was the target organ following fluopy ram exposure across specie s and exposure duration s . Treatment
- related thy roid effects were also observed at dose levels causing adverse liver perturbations in rats and mice. Decreased body weight w as a common clinical finding throughout the toxicology database. Liver tumors were observed in female rats and thy roid tumors were observed in male mice in chronic feeding studies ; however , a nongenotoxic mode of action was adequatel y demonstrated for the liver and thyroid tumors. Therefore, the Cancer Assessment Review Committee ( CARC ) classified fluopy ram as “Not Likely

to be Carcinogenic to Humans” at doses that do not induce cellular pro liferation in the liver or thy roid glands
. Fluopy ram is not genotoxic or mutagenic. HED recommends that the Food Quality Protection Act (FQPA) safety factor be reduced to 1x b ecause there are no residual uncertainties with regard to pre
- and postnatal su sceptibility, the toxicology

database is complete, and there is no evidence of neurotoxicity
. An acute dietary endpoint for the general population (including infants and children) was selected from the acute neurotoxicity study in rats based on decreased motor and locomotor

### Fluopy

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Page **7** of **87** activity (no observed adverse effect level (NOAEL = 50 mg/kg). Because this effect was reversible within 48 hours and attributed to generalized systemic toxicity , fluopy ram is not considered a neurotoxicant
. The chronic dietary endpoint was based primarily on liver and thy roid effects in the chronic toxicity /carcinogenicity

study in rats (NOAEL = 1.2 mg/kg/day)
. Short
- and intermediate
- term dermal endpoints were chosen from a derm al toxicity study in rats in which increased prothrombin time and altered cholesterol levels were seen at the limit dose (NOAEL = 300 mg/kg/day). Short
- and intermediate
- term inhalation and short
- term incidental oral endpoints were selected from the multi generation reproduction study in rats based on clinical chemistry

and kidney effects in the parental generation (NOAEL = 1 4. 5 mg/kg/day)
. Inhalation toxicity

is assumed to be equivalent to o ral toxicity
. The level of concern (LOC) for all exposures is an MOE of 100> Dietary Exposure (Food and Water) The residue chemistry

data and environmental fate data are adequate to assess human exposure. The assessments are based on reliable data and are not expected to underestimate exposure/risk. Acute Dietary : The estimated acute dietary exposure to fluopy

ram from food and drinking water is below HED’s level of concern (<100%) for all population subgroups. The acute dietary anal ys is is an unrefined conservative assessment that include s tolerance residue level s, the assumption of 100% crop treated, and processing factors (empirical and default)
. The acute e stimated drinking water concentration (EDWC) was incorporated directly into the dietary assessment ( 97. 6 μg/L) and was calculated b y PRZM
- GW (Pesticide Root Zone Model
- Ground Water) modeling. Combined dietary exposure from food and drinking water at the 95 th 

### percentile of exposure utilized 19 % of the acute population adjusted dose (aPAD) for the general US population, and 3 5 % of the aPAD for children 1
- 2 years , the population subgroup with the highest estimated acute dietary exposure to fluopyram. Chronic Dietary : The estimated chronic dietary exposure to fluopy

ram from food and drinking water is below HED’s level of concern (< 100%) for all population subgroups. The chronic dietary anal ys is is a refined assessment that includes average field trial residue levels, percent crop treated, and processing factors (empirical and default)
. The chronic EDWC was incorporated directl y into the dietary assessment ( 90. 5 μg/L) and was calculated by PRZM
- GW modeling. Chronic dietary exposure utilized 31 % of the chronic population adjusted dose (cPAD) for the general US population, and 8 1 % o f the cPAD for the most highl y exposed population subgroup ( children 1
- 2 years )
. Residential Exposure All residential handler risk estimates are not of concern to HED (all margins of exposure (MOEs ) ≥100), with MOEs ranging from 8,900 to 190,000 for dermal exposures and 260,000 for inhalation exposures
. For treated lawns and turf, all residential post
- application risk estimates are not of concern to HED (all MOEs ≥100), with dermal post
- application MOEs for all life stages ranging from 1,000 to 97,000 and incidental oral post
- application MOEs for children 1 to <2 ye ars old ranging from 2,400 to 1,100,000. For treated gardens, ornamental trees and shrubs, and fruit trees, the dermal

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Page **8** of **87** post - application MOEs for all life stages range from 2,100 to 33,000 and are not of concern to HED (MOEs ≥100). Aggregate Risk There is potential for short
- term, acute and chronic aggregate exposure to fluopy ram. The aggregate acute and chronic risk s are equivalent to the acute and chronic dietary risk s and are not of concern. The short
- term aggregate exposure results from dietary (which is considered background exposure) and residential (which is considered primary) exposure pathways. The short
- term aggregate MOE s for small children and for adults are both 1,500, and are therefore not of concern to HED (LOC <100). Occupational Exposure/Risk For occupational handlers for agricultural crops, turf, and Christmas trees, all short
- and intermediate
- term risk estimates resulted in margins of exposure (MOEs) ≥100, and therefore, do not exceed HED’s level of concern at any level of protection. For dermal exposures at baseline personal protective equipment (PPE), MOEs range from 410 to 1,500,000. For dermal exposures with gloves, MOEs range from 2,400 to 1,100,000. For inhalation exposures, MOEs range from 7,400 to 5,400,0 00. For the seed treatment use on peanut seeds, risk estimates for dermal and inhalation short
- term occupational handler exposures all resulted in MOEs ≥100, and therefore, do not exceed HED’s level of concern, with MOEs ranging from 1,400 to 9,200 for dermal exposures and from 1,700 to 17,000 for inhalation exposures. Short
- and intermediate
- term dermal post
- application exposures and risks to occupational workers were estimated using standard values established by HED, since no chemical
- specific data were submitted. For all occupational post
- application scenarios , the dermal MOEs, at day zero following application, do not exceed HED’s level of concern (MOEs ≥100), with dermal MOEs ranging from 270 to 23,000. Additionally, several post
- application wor ker scenarios involved with the mechanical harvesting of cotton were assessed. The dermal exposures to these harvesters of cotton resulted in risk estimate MOEs ranging from 3,100,000 to 17,000,000, which also do not exceed HED’s level of concern (MOEs ≥1 00). Based on the Agency's current practices, a quantitative occupational post
- application inhalation exposure assessment was not performed for fluop yram at this time. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post
application inhalation exposure assessment for fluopy ram . Restricted Entry Interval (REI) : The 12
- hour REI that appears on the proposed labels is adequate to protect for worker exposure
. Review of Human Research This risk assessment relies in part on data from studies in which adult human subjects were intentionally

exposed to a pesticide or other chemical. These studies (Appendix C ) have been determined to require a review of their ethical conduct, and one of th ese studies is also subject to review b y the Human Studies Review Board. All of the listed studies have received the appropriate review.

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Page **9** of **87** Environmental Justice Potential areas of environmental justice concerns, to the extent possible, were considered in t his human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low - Income Populations," http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf ). **2.0 HED**  **Recommendations** Pending submission of a revised Section B (see Section 2.3 , Lab el Recommendations), a revised Section F (see Section 2.2.3 , Recommended Tolerances), and an anal ytical reference standard (see Section 2.1 under Submittal of Analy tical Reference Standards), there are no issues that would preclude granting Section 3 registration for the requested uses of fluopy ram and establishing/amending tolerances for fluop yr am (both primary and inadvertent) on the requested crops. **2.1 Data Deficiencies**  Pending submission of an anal ytical reference standard, there are no data gaps that need to be fulfilled for the requested actions. OCSPP 860.1650 Submittal of Anal ytical Reference Standards An anal ytical reference standard for the AE C656948
-benzamide metabolite must be submitted. The registrant is required to submit a reasonable amount of the anal ytical reference standard for the benzamide. The reference standard should be sent to the Analy tical Chemistry

L ab, which is located at Fort Meade, Maryland, to the attention of either Theresa Cole or Thuy Nguye n at the following address: USEPA National Pesticide Standards Repository /Anal ytical Chemistry

Branch/OPP 701 Mapes Road Fort George G. Meade, MD 20755
- 5350 (Note that the mail will be returned if the extended zip code is not used.) **2.2 Tolerance Considerations**  **2.2.1 Enforcement Analytical Method**  The German multiresidue method DFG Method S 19, a gas chromatography with mas s selective detection (GC/MSD) method, is the method for the enforcement of tolerances for fluopy ram residues in/on crop commodities
. The method was previousl y validated using samples of orange (fruit), oil seed rape (seeds), wheat (grain), lettuce (head) and dry peas (seeds). For fluopy ram in these commodities , the limit of quantitation ( LOQ ) was 0.01 ppm, and the calculated limit of detection (LOD) was 0.003 ppm. The method was subjected to independent laboratory validation (ILV) using samples of cabbage (head), wheat (grain), orange (fruit) , and oil seed rape

### Fluopy

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Page **10** of **87** (seed) fortified with fluopy ram at 0.01 ppm and 0.10 ppm. The average recoveries were within acceptable limits (70
- 120%), and relative standard deviations (RSDs ) were <20%. A high performance liquid chromatography method with tandem mass spectrometry detection (HPL C/MS/MS), Method 01079, has been accepted for the enforcement of tolerances for residues of fluop yr am and its metabolite, AE C656948
-benzamide, in livestock commodities. The LOQ is 0 .01 ppm and the calculated LOD is 0.003 ppm for each anal yte in each matrix. The method was adequatel y validated using cattle milk, fat, muscle, liver, and kidney, and hen whole egg fortified with fluop yr am and AE C656948
-benzamide, each at 0.01 and 0.10 ppm. The method was subjected to ILV using samples of milk, eggs, beef muscle, and beef liver fortified with fluopy

ram and AE C656948
-benzamide, each at 0.01 and 0.10 ppm (D387587, L . Cheng, 09/23/2011). **2.2.2 International Harmonization**  The tolerance definitions are harmonized among the US, Canada, and Codex for all plant and livestock commodities. Harmonization with Codex is not possible because the recommended US tolerances are for crop groups/subgroups and are higher than the Codex maximum residue limits (MRL s) which are established mostly

on the representative crops of the crop group/subgroup, except pome fruits, peach subgroup and tree nuts. The US tolerance on subgroup 13
- 07F can be increased to 2.0 to harmonize with Canada and C odex (grape) MRL. There are Codex maximum residue levels MRL s established on berries (blackberry and raspberry 3 ppm), dry beans (0.07 ppm), broccoli and Brussels sprouts (0.3 ppm), head cabbage (0.15 ppm), cauliflower (0.09 ppm), carrot (0.4 ppm), cherry (0.7 ppm), cucumber (0.5 ppm), dried grapes (currants, raisins and sultanas 5 ppm), grapes (2 ppm), lettuce (head and leaf 15 ppm), leek (0.15 ppm), onion bulb (0.07 ppm), peach subgroup (1 ppm), peanut (0.3 ppm), plums (0.5 ppm), pome fruits (0.5 ppm), p otato (0.03 ppm), rapeseed (1 ppm), strawberry (0.4 ppm), sugar beet (0.04 ppm), tomato (0.4 ppm), and tree nuts (0.04 ppm). The established Canadian MRL s and the existing US tolerances are mostl y similar. Canada and the US have received similar petiti on s and the MRLs are harmonized for almost all proposed crops, except so ybean seed, crop subgroup 6C, crop subgroup 8
- 10A, crop subgroup 9B, crop group 15, herb subgroup 19A, and s ubgroup 20A (Refer to Appendix F ). Mainly , the differences are due to different use pattern s and polic ies
. The US and Codex/Canadian livestock MRL s are not harmonized due to different diet s and different proposed/established uses. **2.2.3 Recommended Tolerances**  HED has reviewed the available residue data and has determined the appropriate tolerance levels for residues of fluop yram to be established in/on the following commodities as indicated in Table 2.2. 3
. 1. The recommended tolerance expression is as stated in 40 CFR §180.661 (a), (b), and (d), and this expression agrees with the S. Knizner Memo of 05/27/2009.

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Page **11** of **87 Table**  **2 .2.3**  **.1. Tolerance Summary for Fluopyram**  **.** Commodity Proposed Tolerance (ppm) Recommended/

Harmonized Tolerance (ppm) Comments; Correct Commodity

Definition ARTICHOKE, GLOBE 4.00 4.0 Artichoke, globe Aspirated Grain Fractions 50.00 50 Grain, aspirated grain fractions PEANUT 0.20 0.20 Peanut HOPS, Dried Cone 60.00 60 Hop, dried cones SUGARCANE, cane 0.08 0.08 Sugarcane, cane Tolerances need to be expressed in terms of indirect or inadvertent residues of fluopyram. Use limited to Region 3. VEGETABLES ROOT, Except Sugar Beets 0.30 0.30 Vegetable, root, except sugar beet, subgroup 1B SUGARBEET, ROOTS 0.09 0.10 Sugarbeet, roots VEGETABLES TUBEROUS and CORM 0.10 0.10 Vegetable, tuberous and corm, subgroup 1C POTATO, Wet Peel 0.30 0.30 Potato, wet peel VEGETABLES, leaves of root and tuber 30.00 30 Vegetable, leaves of root and tuber, group 2 VEGETABLES, BULB, Onion, Bulb 0.30 0.40 Onion, bulb, subgroup 3

- 07A VEGETABLES, BULB, Onion, green 15.00 15 Onion, green, subgroup 3

- 07B VEGETABLES LEAFY, Lettuce, including radicchio 20 40 Leafy greens subgroup 4A VEGETABLES LEAFY, Spinach, including amaranth, chervil, chrysanthemum , corn salad, cress, dandelion, endive, orach and purslane 1 40.0

VEGETABLES LEAFY, Celery, including Chinese celery and S wiss chard 20.0 20 Leaf petioles subgroup 4B VEGETABLES, Head & Stem Brassica, 4.00 4.0 Brassica, head and stem, subgroup 5A VEGETABLES, Leafy Brassica Greens 50.00 50 Brassica, leafy greens, subgroup 5B SOYBEAN, seed 0.30 0.30 Soybean, seed VEGETABLES, Legume, Edible podded 4.00 4.0 Vegetable, legume, edible podded, subgroup 6A VEGETABLES, Legume, succulent shelled peas and beans 0.20 0.20 Pea and bean, succulent shelled, subgroup 6B

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Page **12** of **87 Table**  **2 .2.3**  **.1. Tolerance Summary for Fluopyram**  **.** Commodity Proposed Tolerance (ppm) Recommended/

Harmonized Tolerance (ppm) Comments; Correct Commodity

Definition VEGETABLES, Legume, Dried bean, except soybeans and dried peas 0.70 0.15 Bean, dry VEGETABLES, Fruiting, Tomato subgroup 1.0 1.0 Tomato subgroup 8

- 10A VEGETABLES, Fruiting, Pepper/eggplant subgroup 3.0 4.0 Pepper/eggplant subgroup 8

- 10B VEGETABLES, Cucurbit, Melon subgroup 0.90 1.0 Melon subgroup 9A To harmonize with Canada VEGETABLES, Cucurbit , Cucumber/Squash subgroup 0.60 0.60 Squash/cucumber subgroup 9B FRUIT, Citrus 0.90 1.0 Fruit, citrus, group 10

- 10 CITRUS Oil 8.0 8.0 Citrus, oil FRUIT, Pome 0.80 0.80 Fruit, pome, group 11

- 10 FRUIT, Stone, Cherry subgroup 2.00 2.0 Cherry subgroup 12

- 12A FRUIT, Stone, Peach subgroup 1.00 1.0 Peach subgroup 12

- 12B FRUIT, Stone, Plum subgroup 0.50 0.50 Plum subgroup 12

- 12C BERRIES AND SMALL FRUIT, Caneberry 5.00 5.0 Caneberry subgroup 13

- 07A BERRIES AND SMALL FRUIT, Bushberry 7.00 7.0 Bushberry subgroup 13

- 07B BERRIES AND SMALL FRUIT, Small fruit vine climbing, except fuzzy kiwi 1.50 2.0 Fruit, small v ine climbing, except fuzzy kiwifruit, subgroup 13

- 07F To harmonize with Codex/Canada RAISIN 4.00 3.0 Grape, raisin BERRIES AND SMALL FRUIT, Low

Growing Berry 2.00 2.0 Berry, low growing, except cranberry, subgroup 13

- 07G NUT, Tree 0.04 0.05 Nut, tree, group 14

- 12 To harmonize with Canada ALMOND, HULLS 10.00 10 Almond, hulls GRAIN, Cereal, except rice and sorghum, GRAIN 0.90 4.0 Grain, cereal, group 15, except corn and rice 0.02 Corn, field, grain

### Fluopy

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Page **13** of **87 Table**  **2 .2.3**  **.1. Tolerance Summary for Fluopyram**  **.** Commodity Proposed Tolerance (ppm) Recommended/

Harmonized Tolerance (ppm) Comments; Correct Commodity

Definition 0.02 Corn, pop, grain 0.01 Corn, sweet, kernel plus cob with

husks removed Wheat, milled by
-products 2.0 None Covered by the Crop group 15 tolerance GRAIN, Cereal, except rice, FORAGE, FODDER, HAY and STRAW, 20.00 20 Grain, cereal, forage, fodder and straw, group 16 HERBS AND SPICES and Spices, Herb Subgroup 70.00 40 Herb subgroup 19A HERBS, Dried 40.00 Dill seed, Including

– Caraway seed, celery seed, coriael seed, lovage seed, mustard seed and poppy seed 1 70 70 Dill, seed; caraway seed; celery seed; coriander, seed

; lovage seed; mustard seed; poppy seed OILSEEDS, RAPESEED (CANOLA) 0.7 5.0 Rapeseed subgroup 20A OILSEEDS, SUNFLOWER, SEED 0.70 0.70 Sunflower subgroup 20B OILSEEDS, COTTONSEED 0.80 0.80 Cottonseed subgroup 20C COTTON, Gin By
-products 30.00 30 Cotton, gin byproducts **Tolerances proposed for residues of fluopyram and its metabolite 2**  **- (trifluorom**  **ethyl)benzamide, expressed in parent equivalents:**  CATTLE MEAT, BY PRODUCTS 40.00 7.5 Cattle, meat byproducts CATTLE, FAT 4.00 0.70 Cattle, fat CATTLE, MEAT 4.00 0.80 Cattle, meat MILK, CATTLE 2.00 0.40 Milk CHICKEN MEAT, BYPRODUCTS 0.40 0.16 Poultry, meat byproducts CHICKEN, FAT 0.15 0.04 Poultry, fat CHICKEN, MEAT 0.10 0.04 Poultry, meat EGGS, CHICKEN 0.20 0.08 Egg HOG, BY PRODUCTS 0.40 0.20 Hog, meat byproducts HOG, FAT 0.04 0.20 Hog, fat HOG, MEAT 0.04 0.02 Hog, meat Horse MEAT, BY PRODUCTS 40.00 7.5 Horse, meat byproducts Horse, FAT 4.00 0.70 Horse, fat Horse, MEAT 4.00 0.80 Horse, meat Goat, BY PRODUCTS 40.00 7.5 Goat, meat byproducts

### Fluopy

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Page **14** of **87 Table**  **2 .2.3**  **.1. Tolerance Summary for Fluopyram**  **.** Commodity Proposed Tolerance (ppm) Recommended/

Harmonized Tolerance (ppm) Comments; Correct Commodity

Definition Goat, FAT 4.00 0.70 Goat, fat Goat, MEAT 4.00 0.80 Goat, meat Sheep, BY PRODUCTS 40.00 7.5 Sheep, meat byproducts Sheep, FAT 4.00 0.70 Sheep, fat Sheep, MEAT 4.00 0.80 Sheep, meat 1 As per HED SOP 2000.1 Crop Group/Subgroup Field Trial Data translation (9/12/2000 **Table 2.2.**  **3 .**  **2. Tolerance Summary for**  **Fluopyram .**  **Comm odity**  **Established**

**Tolerance (ppm)**  **Proposed**

**Tolerance (ppm)**  **HED**  

** Recommended** **Tolerance (ppm)**  **Comments**

**( correct commodity definition**  **)**
**40 CFR**  **§180.661 (1)** Almond, hull 8.0 10 10 Revoke existing tolerance upon establishing tolerances as indicated above
. Apple 0.30 Proposed as crop group 0.80 Revoke existing tolerance upon establishing tolerances as indicated above
. Apple, wet pomace 0.60 None None Revoke covered under recommended tolerance as crop group 11
. Bean, dry 0.09 Proposed as crop subgroup (0.7) 0.15 Revoke existing tolerance upon establishing tolerances as indicated above
. Beet, sugar, root 0.04 0.09 0.10 Revoke existing tolerance upon establishing tolerances as indicated above
. Cotton, gin byproducts 0.70 30.0 30 Revoke existing tolerance upon establishing tolerances as indicated above
. Cotton, undelinted seed 0.01 Proposed as crop group 0.80 Revoke existing tolerance upon establishing tolerances as indicated above
. Cherry 0.60 Proposed as crop subgroup 2.0 Revoke existing tolerance upon establishing tolerances as indicated above
. Grape, wine 2.0 Proposed as crop subgroup 2.0 Revoke existing tolerance upon establishing tolerances as indicated above
. Nut, tree, group 14 0.05 0.04 0.05 Revoke existing tolerance upon establishing tolerances as indicated above
. Peanut 0.09 0.20 0.20 Revoke existing tolerance upon establishing tolerances as indicated above
. Pistachio 0.05 Proposed 0.05 Revoke existing tolerance upon

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Page **15** of **87 Table**  **2.2. 3**  **. 2.**  **Tolerance Summary for Fluopyram**  **. Comm** **odity Established** 

**Tolerance (ppm)**  **Proposed**

**Tolerance (ppm)**  **HED**  

** Recommended** **Tolerance (ppm)**  **Comments**

**( correct commodity definition**  **)**
as crop group establishing tolerances as indicated above
. Potato 0.02 Proposed as crop subgroup 0.10 Revoke existing tolerance upon establishing tolerances as indicated above
. Potato, processed potato waste 0.08 None None Revoke covered under recommended tolerance as crop subgroup 1C
. Soy bean, seed 0.04 0.30 0.30 Revoke existing tolerance upon establishing tolerances as indicated above
. Straw berry 1.5 Proposed as crop subgroup 2.0 Revoke existing tolerance upon establishing tolerances as indicated above
. Watermelon 1.0 Proposed as crop subgroup 1.0 Revoke existing tolerance upon establishing tolerances as indicated above
. **40 CFR**  **§180.661 (2)** Cattle, fat 0.05 4.0 0.70 For all (except hog meat), higher tolerances than established were recommended. Revoke existing tolerances upon establishing tolerances as indicated. Cattle, meat 0.05 4.0 0.80 Cattle, meat byproducts 0.40 40 7.5 Egg 0.06 0.20 0.08 Goat, fat 0.11 4.0 0.70 Goat, meat 0.15 4.0 0.80 Goat, meat byproducts 1.1 40 7.5 Hog, fat 0.02 0.04 0.20 Hog, meat 0.02 0.04 0.02 Hog, meat byproducts 0.03 40 0.20 Horse, fat 0.11 4.0 0.70 Horse, meat 0.15 4.0 0.80 Horse, meat byproducts 1.1 40 7.5 Milk 0.06 2.0 0.40 Poultry, fat 0.03 0.15 0.04 Poultry, meat 0.03 0.10 0.04 Poultry, meat byproducts 0.10 0.40 0.16 Sheep, fat 0.11 4.0 0.70 Sheep, meat 0.15 4.0 0.80 Sheep, meat byproducts 1.1 40 7.5 **40 CFR**  **§180.661 (d) Indirect or inadvertent residues** Canola, seed 1.8 Revoke Revoke existing tolerance upon establishing tolerances under 40 CFR §180.661 (1) Grain, cereal, except rice, group 0.03

### Fluopy

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Page **16** of **87 Table**  **2.2. 3**  **. 2.**  **Tolerance Summary for Fluopyram**  **. Comm** **odity Established** 

**Tolerance (ppm)**  **Proposed**

**Tolerance (ppm)**  **HED**  

** Recommended** **Tolerance (ppm)**  **Comments**

**( correct commodity definition**  **)**
15 Grain, cereal, forage, fodder and straw , group 16 2.0 Soy bean, forage 0.80 Soy bean, hay 3.0 **Tolerance that Need to be Proposed 40CFR§180.661 (c) Regional Registration Indirect or inadvertent**  **residues** Sugarcane, cane None 0.08 0.08 Propose tolerance for Regional Registration (Region 3) 

### 2.2.4 **Revisions to Petitioned -**  **For Tolerances** The petitioned for tolerances differ from the recommended tolerances for sugar beet roots, onion bulbs, leafy

greens subgroup 4A, crop subgroup 6C, fruiting vegetables (8
- 10B), melon subgroup 9A, citrus, subgroup 13
- 07F, raisin, tree nuts, crop group 15, herb subgroup 19A, dill seed, and subgroup 20A. For onion bulbs, citrus, tree nuts, crop group 15, rapeseed subgroup 20A, the Organization for Economic Cooperation and Development (OECD) statistical calculation procedures applied to the field trial residue data provided a different value than the proposed v alues. For crop group 15 (sorghum) and rapeseed subgroup 20A (canola), the petitioner excluded a field trial as an outlier based on statistical tests. However, the trial s could not be excluded by the Agency since there were no abnormal field conditions. Inaddition, f or crop group 15, the minimum (sweet corn 0.01 ppm) and the maximum (wheat 0.72 ppm) residues differ b y more than 5x. Therefore, the tolerance level (0.09 ppm) is not appropriate to establish a crop group tolerance. The proposed tolerance expressions on leafy vegetables and leafy

petioles were not appropriate. The available data support a tolerance of 40 ppm for residues of fluopy ram in/on crop subgroup 4A and at 20 ppm on crop subgroup 4B. The petitioner has reques ted to establish tolerances on dill seed , including caraway seed, celery seed, coriander seed, fennel seed, lovage seed, mustard seed and poppy seed. The request to translate from dill seed to these commodities is accepted since the exposure s from these c ommodities are insignificant. However, separate tolerances, at 70 ppm, are needed for dill, seed; caraway

seed; celery

seed; coriander, seed ; lovage seed; mustard seed; and poppy seed
. For harmonization purposes, tolerances for sugar beet roots, melon su bgroup 9A, and subgroup 13
- 07F were slightly

increased and tolerances for tree nuts were slightly decreased. Separate tolerances were proposed for herbs and spices, subgroup 19A and dried herbs. Onl y

### Fluopy

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Page **17** of **87** one tolerance is possible for fresh and dried herbs; therefore, the higher value (40 ppm) is recommended. The proposed grape, raisin tolerance of 4.0 ppm is not supported by the data. A tolerance of 3.0 ppm needs to be proposed based on the HAFT (0.948 ppm) for grape and processing factor of 2.4. The proposed tolerance for sugarcane, cane (0.08 ppm) must be revised to be specified in terms of indirect or inadvertent residues of fluop yr am for regional registration. All proposed tolerances for livestock commodities are too high. The petitioner must prop ose tolerances as specified above in Table 2.2. 3
. 1. The proposed tolerances should be revised to reflect the correct commodity definitions as specified above in Table 2.2
. 3
. 1. **2.3 Label Recommendations**  Some of the proposed products for fluop yr am are intended for use b y residential applicators on home lawns or residential areas , but require certain clothing and/or PPE to be worn. Thus, standard assumptions for residential/consumer applicator specific assessments, such as wearing shorts and a t
- shirt without PPE like chemical
- resistant gloves or respirators, would represent non - compliance with currently registered products. If products containing fluopy ram are meant to be marketed towards and applied by residential handlers on residential turf, ornamentals, fruit trees, or gardens , HED recommends that the label requirements for clothing and/or PPE be reevaluated or separate consumer
- specific labels be developed. The proposed label for EPA Reg. No. 264
- 1078 must be revised as follows:  to modify

the proposed PHI s for dried bean seeds (crop subgroup 6C) and soy bean seed to 14 days;  to revise “Dried shelled pea and bean” to “Dried shelled bean” under legume vegetables (except soy

beans) listing;  to modify

“May be applied broadcast the day of harvest (fi eld and greenhouse uses) with “May be applied broadcast the day of harvest (field uses).  to add a separate entry for dill seed including (caraway seed, celery

seed, coriander seed, fennel seed, lovage seed, mustard seed and popp y seed) with the same use pattern as proposed under the “Herbs and dill seed” listing with a 14
- day PHI instead of a 3
- day PHI ;  to modify

“legume vegetables (including soy beans)” with “legume vegetables (except cowpeas and dried peas); soy beans) throughout the use directions of LUNA PRIVILEGE (labeled uses, rotational crops etc)  to modify

the rotational crop restrictions to replace the statement “Sugarcane and alfalfa may be planted after 14 days” with “Alfalfa may be planted after 14 days and sugarcane may be planted after 14 days in Region 3”  to remove “Do not graze or feed so yb ean forage and hay to livestock after treating with

### Fluopy

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Page **18** of **87** Luna Privilege” from the use directions of cotton seed treatment;  to modify

“herbs and spices (except black pepper)” to “herbs (fresh and dried); dill seed including (caraway

seed, celery

seed, coriander seed, fennel seed, lovage seed, mustard seed and popp y seed)” from the use directions of peanut seed treatment plant back restrictions. The product labels for EPA Reg. Nos. 264
- 1084 and 264
- 1085 must be am ended as follows:  to specify

that sugarcane may

be rotated 30
- days after application in Region 3.  to modify

“legume vegetables (including soy beans)” to “legume vegetables (except cowpeas and dried peas); soy beans) under rotational crops. The product label for EPA Reg. No. 264
- 1091 should be amended as follows:  to modify

“legume vegetables (including soy beans)” to “legume vegetables (except cowpeas and dried peas); soy beans) under rotational crops;  to specify

that sugarcane may

be rotated 120
- days after app lication in Region 3.  to delete the sentence “Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed within 14 days of application” “Under barley ; corn (sweet corn, field corn, field corn grown for seed, and popcorn); and wheat use directions. The PHI’s for these crops are not 14
- days. The product label for EPA Reg. No. 264
- 1090 must be amended as follows:  to correct the listed crops in the Brassica leafy vegetable crop subgroups: (head and stem subgroup): “Chinese cabbage (bok cho y) ” should be removed; and in the leafy greens subgroup, “Chinese Cabbage” should be revised to “Chinese cabbage (bok choy)”  to add a separate entry for dill seed including (caraway seed, celery

seed, coriander seed, fennel seed, lovage se ed, mustard seed and popp y seed) with the same use pattern as proposed under the “Herbs and dill seed” listing with a 14
- day PHI instead of a 3
- day PHI ;  to specify

that sugarcane may

be rotated 14
- days after application in Region 3. The product label for EPA Reg. No. 264
- 1167 must be amended as follows:  to modify

“legume vegetables (including soy beans)” with “legume vegetables (except cowpeas and dried peas); soy beans) under rotational crop restrictions listing  to modify

the rotational crop restrictions to replace the statement “Sugarcane and alfalfa may be planted after 14 days” with “Alfalfa may be planted after 14 days and sugarcane may be planted after 14 days in Region 3” **3.0 In**  **troduction** Fluopy ram (AE C656948) is a Group 7 fungicide with a broad spectrum of activity against numerous fungal diseases, including Ascomyc etes, leaf spots, molds, sc a b, Alternaria, Septoria, Moni linia, Botry

tis, Sclerotinia, and powdery mildews in a wide range of crops and plants. Fluopy ram represents is a py

ridyl ethylamide and its biochemical mode of action has been shown to rely on the inhibition of the enzy me succinate dehydrogenase (complex II) within the fungal mitochondrial respiratory chain, thus blocking electron transport.

### Fluopy

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Page **19** of **87 3.1**  **Chemical Identity Table**  **3.1. F**  **luopyram No**  **me nclature** 
. Chemical structure

Common name Fluopyram Com pany experimental name AE C656948 IUPAC name N
- [2
- [3
- c hloro
- 5
- (trifluoromethyl)
- 2
-pyridyl]ethyl]
- α,α,α - trifluoro
- o - toluamide CAS name N
- [2
- [3
- c hloro
- 5
- (trifluoromethyl)
- 2
-pyridinyl]ethyl]
- 2
- (trifluoromethyl)benzamide CAS registry number 658066
- 35
- 4 End
- use product (EP) 264
- 1 167 Fluopyram ST; 264
- 107 8 Luna® Privilege ; 264
- 1084 Propulse; 264
- 1085 Luna Tranquility; 264
- 1090 Luna Sensation; 264
- 1091 Luna Experience Chemical structure of AE C656948
-benzamide metabolite (included in the tolerance expression for livestock commodities) 2
- (T rifluoromethyl)
-benzamide 

### 3.2 **Physical/Chemical Characteristics** Fluopy ram is not a highly

lipophilic molecule (log KOW 

### = 3.3) and is not expected to pass the dermal barrier, pass through human milk , or bioaccumulate in significant quantity . Emp irical dermal absorption data estimate that less than 2% is absorbed dermally in humans and metabolism data in rats demonstrate rapid absorption with ~98% elimination with 72 hours of administration. Fluopy

ram is persistent in soil ( its half
- life is 4 64 days) with very little abiotic degradation
. Fluopy

ram , the major environmental residue and onl y compound modeled for drinking water exposure, is mobile , soluble , and stable in water
. A summary of the physical and chemical properties of fluopy ram are presented in Appendix B. **3.3 Pesticide Use Pattern**  Fluopy ram is currentl y registered on a variety of agricultural food crops, including apple, cherry (sweet and tart), cotton, dried beans, peanut, potato, strawberry , sugar beets, tree nuts, watermelon, viniferous variety grapes, and for seed treatment to cotton and soy bean. There are currentl y no existing residential uses of fluopy ram. The registrant, Baye r CropScience, is requesting the addition of new uses of fluopy ram on registered liquid formulation product labels, as follows: CF 3 N

H O N

Cl CF 3

CF 3 N H

2 O

### Fluopy

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Page **20** of **87** 1) The Luna ® 

### Privilege label (4.16 lb ai/gal) [EPA Reg. No. 264
- 1078] contains only the active ingredient fluop yr am. New uses are proposed on artichoke (globe), Brassica (cole) leafy

vegetables, bulb vegetables, canola, carrot, cereal grains (except rice), citrus, co tton, cucurbit vegetables, fruiting vegetables, ginseng, grapes and small vines fruits (except fuzzy

kiwifruit), herbs and spices (except black pepper), hops, leafy vegetables, legume vegetables (including so ybean), peanut, pome fruits, potato and other ro ot, tuberous and corm vegetables, small berries (caneberries and bushberries), stone fruit, strawberry

and other low growing berries (except cranberries), sugar beet, sunflower subgroup, and tree nuts. Additionally , the Luna Privilege label is also propos ed for use as a seed treatment to peanuts. 2) The Propulse TM 

### label (1.67 lb ai/gal) [EPA Reg. No. 264
- 1084] contains the active ingredients fluopy

ram and prothioconazole. New uses are proposed on barley , buckwheat, bushberry

subgroup, canola, corn, cramb e, cucurbit vegetables, field mustard, Indian rapeseed, low growing berries (except strawberries and cranberries), millet (pearl and proso), oats, rapeseed, rye, soy bean, triticale, and wheat (spring, durum, and winter). 3) The Luna ® 

### Tranquility label (1. 04 lb ai/gal) [EPA Reg. No. 264
- 1085] contains the active ingredients fluop yram and p yrimethanil. New uses are proposed on bulb vegetables, ginseng, lemons, pome fruit, tuberous and corm vegetables, small berries (caneberries and bushberries), stone fruit (except cherries), strawberries and other low
growing berries (except cranberries), and tomato. 4) The Luna ® 

### Sensation label (2.1 lb ai/gal) [EPA Reg. No. 264
- 1090] contains the active ingredients fluopy

ram and trifloxystrobin. New uses are proposed on artichoke (globe), Brassica (head and stem subgroup), Brassica (leafy greens subgroup), carrot, citrus, cucurbit vegetables, fruiting vegetables, ginseng, grapes and small vines fruits (except fuzzy kiwifruit), herbs and spices (except black pepper), hops, leafy vegetables (leafy greens subgroup), leafy

vegetables (leaf petioles subgroup), pome fruits, potato and other root, tuberous and corm vegetables, so ybean, stone fruit, strawberry and other low growing berries (except cranberries), and wheat. 5) The Luna ® 

### Experience label (1.67 lb ai/gal) [EPA Reg. No. 264
- 1091] contains the active ingredients fluop yram and tebuconazole. New uses are proposed on barley , bean (fresh and dry , except succulent shelled), bulb vegetable, corn (sweet corn, field corn, fiel d corn grown for seed, and popcorn), cotton, cucurbit vegetables, fruiting vegetables, grapes and small vines fruits (except fuzzy kiwifruit), hops, leafy Brassica greens, okra, pome fruits, soy

bean, stone fruit, sunflower, and wheat. Baye r CropScience, i s also requesting the registration of several new end
- use products containing the following new non
- food uses of fluopy ram: turf grass (golf courses, sod farms, sports fields, residential, industrial, municipal, commercial, and other turf grass areas), orn amentals (in residential and commercial landscapes, interiorscapes, field grown and container ornamentals, in nurseries, and greenhouses, lathhouses, shadehouses, containers and other enclosed structures), and Christmas trees. These new end
- use product la bels also include

### Fluopy

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Page **21** of **87** proposed uses on citrus, grapes and small vine fruits, pome fruits, stone fruits, sunflower, and tree nuts. All of these uses can be used b y occupational, as well as residential, handlers. The proposed end
- use product labels are as foll ows: 1) Fluopy ram 500 SC (4.16 lb ai/gal) [EPA File Sy mbol 432
- RL GI ] which contains the active ingredient fluopy ram; 2) FLU+TFS SC 500 (2.1 lb ai/gal) [EPA File S ymbol 432
- RLGT] which contains the active ingredients fluopy ram and trifloxystrobin; 3) FLU+TF S SC 32.5 (0.104 lb ai/gal) [EPA File S ymbol 432
- RLGA] which contains the active ingredients fluopy ram and trifloxystrobin; 4) FLU+TFS SC 25 (0.104 lb ai/gal) [EPA File S ymbol 432
- RLGL] which contains the active ingredients fluopy ram and trifloxystrobin; and 5) 13ESP715 3.3 SC (3.34 lb ai/gal) [EPA File S ymbol 432
- RLUG] which contains the active ingredient fluopy ram. The proposed labels require occupational handlers to wear the following attire and PPE: long sleeved shirts, long pants, shoes, socks, and chemical resistant gloves. However, the FLU+TFS SC 32.5 and FLU+TFS SC 25 labels do not require the use of gloves. Additionally , for seed treatment of peanuts, the Luna ® 

### Privilege label requires water proof gloves for seed treatment activities and no glo ves for baggers and bag sewers. On all registered and proposed labels the proposed REIfor new uses is 12 hours. The proposed uses and application rates are described in detail in Table 3.3 .1.

### Fluopy

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Page **22** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  **Agricultural Use Sites**
Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Artichok e (globe)**  0.104 to 0.222 (3.2 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 7 to 10 days. Luna Sensation (2.1 lb ai/gal) [264
- 1090] 0.0660 to 0.125 (4.0 to 7.6 fl oz/A)
Gr ound, aerial or chemigation Luna Sensation

(2.1 lb ai/gal) [264
- 1090] **Brassica Leafy Vegetables Head and Stem Subgroup:**  Broccoli, Chinese broccoli (Gai Lon), Brussels sprouts, Cabbage, Chinese cabbage (Napa), Chinese cabbage (Bok choy), Chinese mustard cabbage (Gai choy), Cauliflower, Cavalo broccolo, Kohlrabbi. I ncluding all cultivars and/or hybrids of these. 0.0660 to 0.125 (4.0 to 7.6 fl oz/A) NS 0.446 0 Retreatment interval of 7 to 10 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Brassica (cole) Leafy Vegetables**  : Broccoli, Broccoli raab (Rapini), Brussels sprouts, Cabbage, Cauliflower, Cavalo broccoli, Chinese broccoli (Gai Lon), Chinese cabbage (Bok choy), Chinese cabbage (Napa), Chinese mustard cabbage (Gai choy), Collards, Kale, Mizuna, Mustard greens, Mustard spinach, Rape greens, and Turnip greens. I ncluding all cultivars and/or hybrids of these. 0.104 to 0.222 (3.2 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 5 to 10 days.

Luna Sensation (2.1 lb ai/gal) [264
- 1090] **Brassica Leafy Vegetables Leafy Greens Subgroup**  : Broccoli raab (Rapini), Chinese cabbage, Collards, Kale, Mizuna, Mustard greens, Mustard spinach, Rape greens, and Turnip greens. I

ncluding all cultivars and/or hybrids of these. 0.0660 to 0.125 (4.0 to 7.6 fl oz/A) NS 0.446 0 Retreatment interval of 7 to 14 days. Luna Experience (1.67 lb ai/gal) [264
- 1091] **Leafy Brassica**  **Greens (Crop Subgroup 5B)** : Broccoli raab (rapini), Chinese cabbage (bok choy), Collards, Kale, Mizuma, Mustard greens, Mustard spinach, Rape greens, and

Turnip greens, 0.0783 to 0.112 (6.0 to 8.6 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Bulb Vegetables** : Chive fresh leaves, Chive fresh leaves (Chinese), Daylily bulb, Elegans hosta, Fritillaria (bulb and leaves), Garlic bulb, Garlib bulb (Great headed and Serpent), Kurrant, Leek, Leek (Lady’s and Wild), Lily bulb, Onion (Beltsville bunching, Bulb, Chinese bulb, Fresh, Green, Macrostem, Pearl, Potato bulb, Tree tops, and Welsh), Shallot (bulb and fresh leav es). I ncluding all cultivars and/or hybrids of these. 0.13 to 0.222 (4.0 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 5 to 7 days.

Luna Experience (1.67 lb ai/gal) [264
- 1091] **Bulb Vegetables** : Chive fresh leaves, Chive fresh leaves (Chinese), Daylily bulb, Elegans hosta, Fritillaria (bulb and leaves), Garlic bulb, Garlic bulb (Great headed and Serpent), Kurrant, Leek, Leek (Lady’s and Wild), Lily bulb, Onion 0.104 to 0.167 (8.0 to 12.8 fl oz/A) NS 0.446 7 Retreatment interval of 10 to 14 days.

### Fluopy

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Page **23** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  (Beltsville bunching, Bulb, Chinese bulb, Fresh, Green, Macrostem, Pearl, Potato bulb, Tree tops, and Welsh), Shallot

(bulb and fresh leaves). Luna Tranquility (1.04 lb ai/gal) [264
- 1085] **Bulb Vegetables**  : Dry Bulb Onion, Eschalots, Green Onion,

Garlic, Leeks, Japanese Bunching Onion, Scallions, Shallot,

and Spring Onion. 0.130 to 0.219 (16.0 to 27.0 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 14 days.
Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Canola subgroup** : Borage, Crambe, Cuphea, Echium, Flax seed, Gold of pleasure, Hare’ ear mustard, Lesquerella, Lunaria, Meadowfoam, Milkweed, Mustard seed, Oil radish, Poppy seed, Rapeseed, Sesame, and Sweet rocket. I nc luding cultivars, varieties, and/or hybrids of these. 0.222 (6.84 fl oz/A) NS 0.446 14 Retreatment interval of 12 to 14 days.
Gr ound, aerial or chemigation Propulse

(1.67 lb ai/gal) [264
- 1084] **Canola Rapeseed, Indian Rapeseed, Field Mustard, Crambe**  0.177 (13.6 fl oz/A) NS 0.446 36 Retreatment interval of 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Carrot** 0.156 to 0.222 (4.8 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 5 to 7 days. Tops or greens from this crop may be utilized for food or feed. Luna Sensation (2.1 lb ai/gal) [264
- 1090] 0.0660 to 0.125 (4.0 to 7.6 fl oz/A) 7 Retreatment interval of 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Cereal Grains (except Rice)** : Barley, Buckwheat, Corn (Sweet Corn, Field Corn, Field Corn Grown for Seed, and Popcorn), Millet, (Pearl and Proso), Oats, Rye, Sorghum, Sudan Grass, Teosinte, Triticale, and Wheat. 0.222 (6.84 fl oz/A) NS 0.446 14 Retreatment interval of 14 days. Do not allow livestock to graze treated area for 14 days and do harvest for food or feed within 14 days of application.

Gr ound, aerial or chemigation Propulse

(1.67 lb ai/gal) [264
- 1084] **Barley** 0.177 (13.6 fl oz/A) NS 0.446 32 Retreatment interval of 14 days.
Luna Experience (1.67 lb ai/gal) [264
- 1091] **Barley** 0.112 (8.6 fl oz/A) NS 0.446 30 Retreatment interval not specified. Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed within 14 days of application. Gr ound or aerial Propulse

(1.67 lb ai/gal) [264
- 1084] **Buck wheat, Millet (Pearl and Proso), Oats, Rye**  0.177 (13.6 fl oz/A) NS 0.446 30 Gr ound, aerial Propulse **Wheat** 0.177 NS 0.446 30 Retreatment interval of 14

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **24** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  or chemigation (1.67 lb ai/gal)

[264
- 1084] (13.6 fl oz/A) days.

Luna Sensation (2.1 lb ai/gal) [264
- 1090] **Wheat** 0.112 (6.84 fl oz/A) NS 0.446 35 Retreatment interval of 14 to 21 days. If two applications or 0.224 lb ai/A/yr are applied, do not allow livestock to graze within the treated area and do not harvest the treated crop for forage or hay. If one application or 0.112 lb ai/A/yr are applied, do not allow livestock to graze within the treated area within 30 days after application, and do not harvest the treated crop for forag e within 30 days after application or for hay within 45 days after application.
Luna Experience (1.67 lb ai/gal) [264
- 1091] **Wheat** 0.112 (8.6 fl oz/A) NS 0.446 30 Retreatment interval not specified. Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed for 14 days of application.
Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Forage, Fodder or Straw from Cereal Grains:** Barley,

Buckwheat, Corn (Sweet Corn, Field Corn, Field Corn Grown for Seed, and Popcorn), Millet, (Pearl and Proso), Oats, Rye, Sorghum, Sudan Grass, Teosinte, Triticale, and Wheat. 0.222 (6.84 fl oz/A) NS 0.446 14 Retreatment interval of 14 days. Do not allow livestock to graze treated area for 14 days and do harvest for food or feed within 14 days of application.
Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Citrus** : Australian desert lime, Australian finger
- lime, Brown River finger lime, Calamondin, Citron, Citrus hybrids, Grapefruit, Japanese summer grapefruit, Kumquat, Lemon, Li me, Mediterranean mandarin, Mount white lime, New Guinea wild lime, Orange (sour and sw eet), Pummelo, Russell River lime, Satsuma mandarin, Sweet lime, Tachibana orange, Tahiti lime, Tangelo, Tangerine 0.156 to 0.222 (4.8 to 6.84 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 21 days. Minimum 30 day interval between soil applications.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **25** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  (Mandarin), Tangor, Trifoliate orange, Uniq fruit, White sapote (Casimiroa spp.) and cultivars, varieties, and/or

hybrids of these. Luna Sensation (2.1 lb ai/gal) [264
- 1090] **Citrus** : Calamondin, Citrus Citron, Citrus hybrids ( Citrus spp., includes Chironja, Tangelo and Tangor), Grapefruit, Grapefruit, Kumquat, Lemon, Lime, Mandarin (Tangerine), Orange (Sweet and Sour), Pummelo, Tangelo, Satsuma Mandarin, White Sapote (Casimiroa spp.), and other cultivars

and/or hybrids of these. 0.12 5 (7.6 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 21 days. Fluopyram 500 SC (4.16 lb ai/gal) [264
- RLGI]
**Citrus** 0.156 to 0.221 lb ai/100 gal/A 4.8 to 6.8 fl oz/100 gal/A

NS 0.446 lb ai/A 13.7 fl oz/A

7 Retreatment interval of 7 to 21 days. Retreatment interval for nematode control is 30 days. FLU+TFS SC 500 (2.10 lb ai/gal) [264
- RLGT] 0.125 lb ai/100 gal/A 7.6 fl oz/100 gal/A 0.446 lb ai/A 27.3 fl oz/A FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.125 lb ai/100 gal/A 154 fl oz/100 gal/A 0.445 lb ai/A 548 fl oz/A 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.157 to 0.446 lb ai/100 gal/A 6.0 to 17.1 fl oz/100 gal/A 0.446 lb ai/A 17.1 fl oz/A Gr ound, aerial or chemigation Luna Tranquility

(1.04 lb ai/gal) [264
- 1085] **Lem on**  0.219 (27.0 fl oz/A) NS 0.446 7 Retreatment interval not specified. The use of adjuvants is prohibited.

Gr ound, aerial or chemigation Propulse

(1.67 lb ai/gal) [264
- 1084] **Corn (including Field Corn, Sweet Corn, Popcorn, and Field Corn grown for seed)**  0.177 (13.6 fl oz/A) NS 0.446 14 0 Retreatment interval of 7 to 14 days. For field corn, field corn grown for seed, and popcorn, do not apply within 14 days of harvest for grain or fodder. For sweet corn, do not apply within 14 days of harvest for fodder. Sweet corn ears and forage may be harvested the same day of application. Luna Experience (1.67 lb ai/gal) [264
- 1091] **Corn (Sweet Corn, Field Corn, Field Corn Grown for Seed, and Popcorn)**  0.167 (12.8 fl oz/A) NS 0.446 See Li mits Retreatment interval of 14

days. For field corn, field corn grown for seed, and popcorn, may be applied up to 21 days before harvest of forage, and 36

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **26** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  days before the harvest of grain or fodder. For sweet corn, may be applied within 7 days before harvest of ears or forage, and 49 days before the harvest of fodder. Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed within 14 days of application.
Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1 078] **Cotton Subgroup (20C): Includes cultivars, varieties and other hybrids of these.**  0.156 to 0.222 (4.8 to 6.84 fl oz/A) NS 0.446 30 Retreatment interval not specified. Luna Experience (1.67 lb ai/gal) [264
- 1091] **Cotton** 0.222 (17.0 fl oz/A) NS 0.446 30 Retreatment interval of 7 to 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Cucurbit Vegetables:** Chayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin (edible, includes Hyotan, Cucuzza, Hechima, Chinese okra), Momordica spp. (includes Balsam apple, Balsam pear, Bitter melon, Chinese cucumber), Muskmelon (hybrids and/or cultivars of Cucumis melo including True cantaloupe, Cantaloupe, Casaba, Crenshaw melon, Golden Pershaw melon, Honeydew melon, Honey balls, Mango melon, Persian melon, Pineapple melon, Santa Claus melon, Snake melon), Pumpkin, Squash (includes Summ er Squash types such as: Crookneck squash, Scallop squash, Straight neck squash, Vegetable marrow, Zucchini, and Winter squash types such as Acorn squash, Butternut squash, Calabaza, Hubbard squash, Spaghetti squash), and Watermelon (includes hybrids and/or varieties of Citrullus lanatus ). 0.104 to 0.222 (3.2 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 5 to 14 days; except for soil applications with minimum 5 day interval between soil applications.

Gr ound or chemigation Propulse

(1.67 lb ai/gal) [264
- 1084] **Cucurbit Vegetables:** Chayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin, Edible gourd (includes hyotan, cucuzza, hechima, Chinese okra), Momordica spp. (includes Balsam apple, Balsam pear, Bitter melon, Chinese cucumber), Muskmelon (includes cantaloupe), Pumpkin, Squash (summer and winter, includes Butternut squash, Calabaza, Hubbard squash, Acorn squash, Spaghetti squash), and Watermelon. 0.177 (13 .6 fl oz/A) NS 0.446 7 Retreatment interval of 5 to 10 days. Only 1 soil application allow; up to two foliar applications allowed. Gr ound, aerial Luna Sensation **Cucurbit Vegetables:** Chayote (fruit), Chinese waxgourd 0.0660 to 0.125 4 0.446 0 Retreatment interval of 7

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **27** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  or chemigation (2.1 lb ai/gal) [264
-

1090] (Chinese preserving melon), Citron melon, Cucumber, Gherkin (edible, includes Hyotan, Cucuzza, Hechima, Chinese okra), Momordica spp. (includes Balsam apple, Balsam pear, Bitter melon, Chinese cucumber), Muskmelon (hybrids and/or cultivars of Cucumis melo including True cantaloupe, Cantaloupe, Casaba, Crenshaw melon, Golden Pershaw melon, Honeydew melon, Honey balls, Mango melon, Persian melon, Pineapple melon, Santa Claus melon, Snake melon), Pumpkin, Squash (includes Summ er Squash types such as: Crookneck squash, Scallop squash, Straight neck squash, Vegetable marrow, Zucchini, and Winter squash types such as Acorn squash, Butternut squash, Calabaza, Hubbard squash, Spaghetti squash), and Watermelon (includes hybrids and/or varieties of Citrullus lanatus ). (4.0 to 7.6 fl oz/A) to 14 days; except for soil applications with minimum 7 day interval between soil applications.

Luna Experience (1.67 lb ai/gal) [264
- 1091] **Cucurbit Vegetables:** Chayote (fruit), Chinese waxgourd (Chinese preserving melon), Citron melon, Cucumber, Gherkin (edible, includes Hyotan, Cucuzza, Hechima, Chinese okra), Momordica spp. (includes Balsam apple, Balsam pear, Bitter melon, Chinese cucumber), Muskmelon (hybrids and/or cultivars of Cucumis melo including True cantaloupe, Cantaloupe, Casaba, Crenshaw melon, Golden Pershaw melon, Honeydew melon, Honey balls, Mango melon, Persian melon, Pineapple melon, Santa Claus melon, Snake melon), Pumpkin, Squash (includes Summer Squash types such as: Crookneck squash, Scallop squash, Straight neck squash, Vegetable marrow, Zucchini, and Winter squash types such as Acorn squash, Butternut squash, Calabaza, Hubbard squash, Spaghetti squash), and Watermelon (includes hybrids and/or varieties of Citrullus lanatus ). 0.0783 to 0.222 (6.0 to 17.0 fl oz/A) NS 0.446 7 Retreatment interval of 10 to 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Fruiting Vegetables:** African eggplant, Bush Tomato,

Cocona, Currant tomato, Eggplant, Garden huckleberry, Goji berry, Martynia, Naranjilla, Okra, Pea eggplant, Pepino, Pepper ( Capsicum spp., including Bell, Chili, Cooking, Pimento and Sweet), Roselle, Scarlet eggplant, Sunber ry, Tomatillo, Tomato, Tree tomato, and cultivars, varieties,

and/or hybrids of these. 0.117 to 0.222 (3.60 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 7 days.
Luna Sensation (2.1 lb ai/gal) [264
- 1090] **Fruiting Vegetables:** Eggplant, Groundcherry, Okra, Pepinos, Pepper ( Capsicum spp., including Bell, Chili, Cooking, Pimento and Sweet), Tomatillo, and Tomato. 0.0825 to 0.125 (5.0 to 7.6 fl oz/A) 5 0.446 3 Retreatment interval of 7 to 14 days. Luna Experience (1.67 lb ai/gal) [264
- 1091] **Fruiting Vegetables:** African eggplant, Bush Tomato,

Cocona, Currant tomato, Eggplant, Garden huckleberry, Goji berry, Martynia, Naranjilla, Pea eggplant, Pepino, Non Bell 0.0783 to 0.222 (6.0 to 17.0 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 14 days.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **28** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  Pepper, Roselle, Scarlet eggplant, Sunberry, Tomatillo, Tomato, Tree tomato, and cultivars, varieties, and/or hybrids of these. Gr ound, aerial or chemigation Luna Experience

(1.67 lb ai/gal) [264
- 1091] **Ok ra**  0.167 (12.8 fl oz/A) NS 0.446 3 Retreatment interval of 14 days.

Gr ound, aerial or chemigation Luna Tranquility

(1.04 lb ai/gal) [264
- 1085] **Tom ato**  0.0910 (11.2 fl oz/A NS 0.446 1 Retreatment interval of 7 to 14 days. For greenhouse uses apply only in well
- ventilated plastic tunnel houses or glass houses. Ventilate for at least 2 hours after application.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Ginseng** 0.222 (6.84 fl oz/A) NS 0.446 7 Retreatment interval of 5 to 7 days. Luna Sensation (2.1 lb ai/gal) [264
- 1090] 0.125 (7.6 fl oz/A) NS 0.446 7 Retreatment interval of 14 days. Luna Tranquility (1.04 lb ai/gal) [264
- 1085] 0.130 to 0.219 (16.0 to 27.0 fl oz/A) NS 0.446 30 Retreatment interval of 7 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Grapes and Small Vine Fruits (except fuzzy k iwifruit)**  : Amur River grape, Gooseberry, Grape, Kiwifruit, Hardy, Maypop, Schisandra berry, and cultivars, varieties, and/or

hybrids of these varieties. 0.104 to 0.222 (3.2 to 6.84 fl oz/A) NS 0.446 7 Retreatment interval of 12 to 21 days. Luna Sensation (2.1 lb ai/gal) [264
- 1090] 0.0660 to 0.125 (4.0 to 7.6 fl oz/A) 6 0.446 14 Retreatment interval of 12 to 21 days. Luna Experience (1.67 lb ai/gal) [264
- 1091] 0.0783 to 0.112 (6.0 to 8.6 fl oz/A) NS 0.446 14 Retreatment interval of 12 to 21 days. Luna Tranquility (1.04 lb ai/gal) [264
- 1085] 0.130 to 0.219 (16.0 to 27.0 fl oz/A) NS 0.446 7 Retreatment interval of 12 to 14 days.
Gr ound, Drench or Chemigation Fluopyram 500 SC

(4.16 lb ai/gal) [264
- RLGI] **Grapes and Small Vine Fruits** 0.104 to 0.221 lb ai/100 gal/A 3.2 to 6.8 fl oz/100 gal/A NS 0.446 lb ai/A 13.7 fl oz/A 7 Retreatment interval of 12 to 21 days. FLU+TFS SC 500 (2.10 lb ai/gal) [264
- RLGT] 0.0656 to 0.125 lb ai/100 gal/A 4.0 to 7.6 fl oz/100 gal/A 6 0.446 lb ai/A 27.3 fl oz/A 14 Retreatment interval of 12 to 21 days.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **29** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.0821 to 0.125 lb ai/100 gal/A 101 to 154 fl oz/100 gal/A 6 0.445 lb ai/A 548 fl oz/A 14 Retreatment interval of 12 to 21 days. 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.112 to 0.223 lb ai/100 gal/A 4.28 to 8.56 fl oz/100 gal/A NS 0.446 lb ai/A 17.1 fl oz/A 7 Retreatment interval of 12 to 21 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Herbs and Spices (except black pepper)**  : Allspice, Angelica, Anise (anise seed), Anise (star), Annatto, (seed), Balm (lemon balm), Basil (fresh and dried), Borage, Bumet, Camomile, Caper buds, Caraway, Caraway (black), Cardamom, Cassia (bark and buds), Catnip, Celery seed, Chervil (dried), Chin ese chive, Chive, Cinnamon, Clary, Clove (buds), Coriander (cilantro or Chinese parsley leaves), Cori an der seed (cilantro seed), Costmary, Cilantro (leaf and seed), Cumin, Curry leaf, Dill (seed), Dillweed, Fennel [common and Florence (seed)], Fenugreek, G rains of paradise, Horehound, Hyssop, Juniper berry, Lavender, Lemongrass, Lovage (leaf and seed), Mace, Marigold, Mustard (seed), Nasturtium, Nutmeg, Parsley (dried), Pennyroyal, Poppy (seed), Rosemary, Rue, Saffron, Sage, Savory (summer and winter), Sweet bay (bay leaf), Tansy, Tarragon, Thyme, Vanilla, Wintergreen, Woodruff, and

Wormwood. 0.13 to 0.222 (4.0 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 7 to 10 days.

Luna Sensation (2.1 lb ai/gal) [264
- 1090] 0.0660 to 0.125 (4.0 to 7.6 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 10 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078]

**Hops** 0.104 to 0.222 (3.2 to 6.84 fl oz/A) NS 0.446 7 Retreatment interval of 14 days.

NS Luna Sensation

(2.1 lb ai/gal) [264
- 1090] 0.0495 to 0.125 (3.0 to 7.6 fl oz/A) 4 0.446 14 Retreatment interval of 14 days. Do not replant areas within 30 days of the last application. Do not graze cover crops within the treated area. Do not harvest cover crops within the area treated for silage and hay. Do not apply using aerial application. Do not apply using low volume applicators. Do not apply through any type of irrigation system. Do not apply on hops in California.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **30** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations** 
Gr ound, aerial or chemigation Luna Experience

(1.67 lb ai/gal) [264
- 109 1] 0.104 to 0.222 (8.0 to 17.0 fl oz/A) NS 0.446 14 Retreatment interval of 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Leafy Vegetables (except Watercress)** : Amaranth (Leafy amaranth, Chinese spinach, Tampala), Arugula (Roquette), Cardoon, Celery, Celtuce, Chervil, Chinese celery, Chrysanthemum, (Edible
- leaved and Garland), Cilantro, Corn salad, Cress (Garden), Cress (Upland, Yellow rocket, Winter cress), Dandelion, Dock (Sorrel), Endive (Escarole), Florence fenn el (Sweet anise, Sweet fennel, Finocchio), Lettuce (Head and Leaf), Orach, Parsley, Purslane (Garden and Winter), Radicchio (Red Chicory), Rhubarb, Spinach [including New Zealand and vine (Malabar spinach, Indian spinach)], and

Swiss chard. 0.104 to 0.222 (3.2 to 6.84 fl oz/A) NS 0.446 0 3 Retreatment interval of 7 to 10 days. For lettuce greenhouse uses the PHI is 3 days.

Luna Sensation (2.1 lb ai/gal) [264
- 1090] **Leafy Greens Vegetables (except Watercress)** : Amaranth (Leafy amaranth, Chinese spinach, Tampala), Arugula (Roquette), Chervil, Chrysanthemum, (Edible
- leaved and Garland), Cilantro, Corn salad, Cress (Garden), Cress (Upland, Yellow rocket, Winter cress), Dandelion, Dock (Sorrel), Endive (Escarole), Lettuce (Head and Leaf), Orach, Parsley, Purslane (Garden and Winter), Radicchio (Red Chicory), Rhubarb, and Spinach [including New Zealand and

vine (Malabar spinach, I

ndian spinach)]. 0.125 (7.6 fl oz/A) NS 0.446 0 Retreatment interval of 14 days.

Gr oun d, aerial or chemigation Luna Sensation

(2.1 lb ai/gal) [264
- 1090] **Leafy Petiole Vegetables:** Cardon, Celery, Chinese celery, Florence fennel (including Sweet anise, Sweet fennel, Finocchio), Rhubarb, Swiss chard. 0.0660 to 0.0957 (4.0 to 5.8 fl oz/A) NS 0.446 7 Retreatment interval of 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Legume Vegetables (including Soybean)** : Edible Podded

Legume Vegetables: Bean ( Phaseolus spp.) (includes Runner Bean, Snap Bean, Wax Bean); Bean (Vigna spp.) (includes Asparagus Bean, Chinese Longbean, Moth Bean, Yardlong Bean); Jackbean; Pea (Pisum spp.) (includes Dwarf Pea, Edible
-pod Pea, Snow Pea, Sugar Snap Pea); Pigeon Pea; Soybean (immature seed); Sword Bean. Succulent Shelled Pea and Bean: Bean (Phaseolus spp.) (includes Lima Bean (green); Broad Bean (succulent); Bean (Vigna spp.) ( except Cowpea, Southpea); Pea (Pisum spp.) (includes English Pea, Garden Pea, Green Pea); Pigeon Pea. Dried Shelled Pea and Bean. Dried Cultivars of Bean (Lupinus spp.) (includes Grain Lupin, Sweet Lupin, White Lupin, White Sweet Lupin); (Phaseolus spp.) (includes Field Bean, Kidney Bean, Lime Bean Dry), Navy Bean, Pinto Bean; Tepary Bean; Bean (Vigna spp .) (includes Adzuki Bean, Blackeyed Pea, Catjang, 0.156 to 0.222 (4.8 to 6.84 fl oz/A) NS 0.446 0 Do not apply to cultivars that are to be grazed, cut for forage or hay, or used as livestock feed.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **31** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  Moth Bean, Mung Bean, Rice Bean, Southern Pea, Urd Bean; except Cowpea & Crowder Pea); Broad Bean (Dry); Chickpea; Guar; Lablab Bean; and Lentil.

Gr ound, aerial or chemigation Propulse

(1.67 lb ai/gal) [264
- 1084] **Dried Beans:** Bean ( Lupinus spp., includes Grain lupin, Sweet lupin, White lupin, and White sweet lupin), Bean ( Phaseolus spp., includes Field bean, Kidney bean, Lima bean, Navy bean, Pinto bean, and Tepary bean), Bean (Vigna spp., includes Adzuki bean, Blackeyed pea, Catjang, Crowd er pea, Moth bean, Mung bean, Rice bean, Southern pea, and Urd bean), Broad Bean (dry), Chickpea, Guar, Lablab Bean,

and Lentil. 0.134 to 0.177 (10.3 to 13.6 fl oz/A) NS 0.446 14 Retreatment interval of 7 to 14 days. Allow 7 days from the last application until cutting or swathing the crop for harvest. Do not feed hay or threshings or allow livestock to graze in treated areas.
Gr ound, aerial or chemigation Luna Experience

(1.67 lb ai/gal) [264
- 1091] **Beans (Fresh and Dry, except Succulent Shelled)** 0.104 to 0.167 (8.0 to 12.8 fl oz/A) NS 0.446 14 Retreatment interval of 10 to 14 days. Do not allow livestock to graze treated area for 14 days and do not harvest for food or feed within 14 days of application.

Gr ound, aerial or chemigation Propulse

(1.67 lb ai/gal) [264
- 1084]

**Soybean** 0.133 (10.2 fl oz/A) NS 0.446 21 Retreatment interval of 10 to 14 days. Do not allow livestock to graze soybean and do not harvest soybean hay for food or feed. Luna Sensation (2.1 lb ai/gal) [264
- 1090] 0.125 (7.6 fl oz/A) NS 0.446 21 Retreatment interval of 14 days. Do not allow livestock to graze soybean and do not harvest soybean hay for food or feed. Luna Experience (1.67 lb ai/gal) [264
- 1091] 0.112 (8.6 fl oz/A) NS 0.446 21 Retreatment interval of 10 to 14 days. Do not allow livestock to graze soybean and do not harvest soybean hay for food or feed.
Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Pom e Fruits**  : Apple, Azarole, Crabapple, Loquat, Mayh aw, Medlar, Pear, Pear (Asian), Quince, Quince (Chinese and Japanese), Tejocote, and cultivars, varieties, and/or hybrids of these. 0.078 to 0.222 (2.4 to 6.84 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 14 days. Luna Experience (1.67 lb ai/gal) [264
- 1091] 0.0652 to 0.130 (5.0 to 10.0 fl oz/A) NS 0.446 75 Retreatment interval of 7 to 14 days.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **32** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  Luna Sensation (2.1 lb ai/gal) [264
- 1090] **Pom e Fruits**  : Apple, Crabapple, Loquat, Mayhaw, Pear, Oriental Pear, Quince. 0.0660 to 0.0957 (4.0 to 5.8 fl oz/A) 4 0.446 14 Retreatment interval of 7 to 14 days. Luna Tranquility (1.04 lb ai/gal) [264
- 1085] 0.0975 to 0.130 (12.0 to 16.0 fl oz/A) NS 0.446 72 Retreatment interval of 7 to 10 days.

Gr ound, Drench or Chemigation Fluopyram 500 SC

(4.16 lb ai/gal) [264
- RLGI]

**Pom e Fruits**  0.0780 to 0.221 lb ai/100 gal/A 2.4 to 6.8 fl oz/100 gal/A NS 0.446 lb ai/A 13.7 fl oz/A 7 Retreatment interval of 7 to 14 days. FLU+TFS SC 500 (2.10 lb ai/gal) [264
- RLGT] 0.0656 to 0.0952 lb ai/100 gal/A 4.0 to 5.8 fl oz/100 gal/A 4 0.345 lb ai/A 21.0 fl oz/A 14 Retreatment interval of 7 to 14 days. FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.0650 to 0.0951 lb ai/100 gal/A 80 to117 fl oz/100 gal/A 4 0.345 lb ai/A 425 fl oz/A 14 Retreatment interval of 7 to 14 days. 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.0783 to 0.223 lb ai/100 gal/A 3.0 to 8.56 fl oz/100 gal/A NS 0.446 lb ai/A 17.1 fl oz/A 7 Retreatment interval of 7 to 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Potato and Other Root, Tuberous, and Corm Vegetables**  : Arracacha, Arrowroot, Artichoke (Chinese and Jerusalem), Beet (Garden), Burdock (Edible), Canna (Edible, Queensland arrowroot), Cassava (Bitter & Sweet), Celeriac (Celery root), Chayote (root), Chervil (Turnip
- rooted), Chickory, Chufa, Dasheen (Taro), Ginger, Horseradish, Leren, Parsley (Turnip
rooted), Parsnip, Potato, Radish, Oriental radish (Daikon), Rutabaga, Salsify (Black), Salsify (Oyster plant), Salsify (Spanish), Skirret, Sweet potato, Tanier (Cocoyam) , Turmeric, Turnip, Yam bean (Jicama, Manoic pea) and Yam (True). 0.13 to 0.222 (4.0 to 6.84 fl oz/A) NS 0.446 7 Retreatment interval of 5 to 7 days. The grazing of livestock in treated areas within 7 days of application is prohibited. Luna Sensation (2.1 lb ai/gal) [264
- 1090] 0.0825 to 0.0957 (5.0 to 5.8 fl oz/A) 4 0.446 7 Retreatment interval of 14 days.

Luna Tranquility (1.04 lb ai/gal) [264
- 1085] **Potato and Other Root, Tuberous, and Corm Vegetables** : Arracacha, Arrowroot, Artichoke (Chinese and Jerusalem), Canna (Edible), Cassava (Bitter & Sweet), Chayote (root), Chufa, Dasheen (Taro), Ginger, Leren, Potato, Sweet Potato, Tanier (Cocoyam), Turmeric, Yam bean, and Yam (True). 0.0650 to 0.0910 (8.0 to 11.2 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Sm all Berries (caneberries and bushberries):** 

**Black berry**  Rubus spp. (including Andean blackberry, Artic blackberry, Bingleberry, Black blackberry, Boysenberry, Brombeere, California blackberry, Chesterberry, Cherokee blackberry, Cheyenne blackberry, Common blackberry, Coryberry, Darrowberry, Dewberry, Dirksen thornle ss berry, Evergreen blackberry, Himalayaberry, Hullberry, Lavacaberry, Loganberry, Lowberry, Lucretiaberry, 0.156 to 0.222 (4.8 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 7 to 10 days.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **33** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  Mammoth blackberry, Marionberry, Mora, Mures deronce, Nectarberry, Northern dewberry, Olallieberry, Oregon evergreen berry, Phenomenalberry, Rangeberry, Ravenberry, Rossberry, Shawnee blackberry, Southern dewberry, Tayberry, Youngberry, Zarzamora, and cultivars, varieties,

and/or hybrids of these. **Raspberry** Rubus spp. (

Rubus occidentalis, Rubus strigosus, Rubus idaeus ) (including Bababery, Black raspb erry, Blackcap, Framboise, Frambueso, Himbeere, Keriberry, Mayberry, Purple raspberry, Red raspberry, Thimblberry, Tulameen, Wild raspberries, Yellow raspberry) and cultivars,

varieties, and/or hybrids of these. **Bushberry** (including Berry (Aronia), Blueber ry (Highbush and Lowbush), Currant (Buffalo), Guava (Chilean), Currant (Black and Red), Barberry (European), Elderberry, Gooseberry, Cranberry (Highbush), Honeysuckle, Huckleberry, Jostaberry, Juneberry, Currant (Native), Salal, Sea buckthorn, and cultivars, varieties, and/or hybrids of these.

Gr ound, aerial or chemigation Luna Tranquility

(1.04 lb ai/gal) [264
- 1085] **Sm all Berries (caneberries and bushberries):** 

**Black berry**  Rubus spp. (including Andean blackberry, Artic blackberry, Bingleberry, Black Satin berry, Boysenberry, Brombeere, California blackberry, Chesterberry, Cherokee blackberry, Cheyenne blackberry, Common blackberry, Coryberry, Darrowberry, Dewberry, Dirksen thornless berry, Evergreen blackberry, Himalayaberry, Hullberry, Lavacaberry, Loganberry, Lowberry, Lucretiaberry, Mammoth blackberry, Marionberry, Mora, Mures deronce, Nectarberry, Northern dewberry, Olallieberry, Oregon evergreen berry, Phenomenalberry, Rangeberry, Ravenberry, Rossberry, Shawnee blackberry, Southern dewberry, Tayberry, Youngberry, Zarzamora, and cultivars, varieties,

and/or hybrids of these. **Raspberry** Rubus spp. (

Rubus occidentalis, Rubus strigosus, Rubus idaeus ) (including Baba bery, Black raspberry, Blackcap, Framboise, Frambueso, Himbeere, Keriberry, Mayberry, Purple raspberry, Red raspberry, Thimblberry, Tulameen, Wild raspberries, Yellow raspberry) and cultivars,

varieties, and/or hybrids of these. **Bushberry** (including Berry (A ronia), Blueberry (Highbush and Lowbush), Currant (Buffalo), Guava (Chilean), Currant (Black and Red), Barberry (European), Elderberry, Gooseberry, Cranberry (Highbush), Honeysuckle, 0.111 to 0.219 (13.6 to 27.0 fl oz/A) NS 0.446 0 Retreatment interval of 7 to 14 days.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **34** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  Huckleberry, Jostaberry, Juneberry, Currant (Native), Salal, Sea buckth orn, and cultivars, varieties, and/or hybrids of these.
Gr ound or chemigation Propulse

(1.67 lb ai/gal) [264
- 1084] **Bushberry subgroup:**  Aronia berry, Blueberry (Highbush

and Lowbush), Chilean Guava, Currant (Black, Buffalo, and Red), Highbush Cranberry, Elderberry, European Barberry, Gooseberry, Edible Honeysuckle, Huckleberry, Jostaberry, Juneberry (Saskatoon berry), Ligonberry, Native Currant, Salal, Sea buckthorn, and cultivars, varieties, and/or hybrids of these. 0.177 (13.6 fl oz/A) NS 0.446 7 Retreatment interval of 7 to 10 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Stone Fruit:** Apricot, Apricot (Japanese), Capulin, Cherry (Black, Nanking, Canada, Sweet, Tart), Jujube (Chinese), Nectarine, Peach, Plum, Plum (American, Beach, Canada, Cherry, Chickasaw, Damson, Japanese, Klamath), Prune, Plumcot, Sloe, and cultivars, varieties, and/or hybrids of the se. 0.13 to 0.222 (4.0 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 5 to 7 days.
Luna Sensation (2.1 lb ai/gal) [264
- 1090] **Stone Fruit:** Apricot, Cherry (Sweet and Tart), Nectarine, Peach, Plum (including Chickasaw, Damson, Japanese), Plumcot, and Prune (Fresh and Dried). 0.0825 to 0.125 (5.0 to 7.6 fl oz/A) 4 0.446 1 Retreatment interval of 7 to 14 days. Luna Experience (1.67 lb ai/gal) [264
- 1091] **Stone Fruit:** Apricot, Cherry (Sweet, Tart), Nectarine, Peach,

Plum (all varieties including Chickasaw, Damson, Japanese, and Stanley), Plumcot, and Prune (fresh and dried). 0.0783 to 0.130 (6.0 to 10.0 fl oz/A NS 0.446 0 Retreatment interval of 5 to 7 days.
Luna Tranquility (1.04 lb ai/gal) [264
- 1085] **Stone Fruit:** Apricot, Nectarine, Peach, Plum (all varieties including Chickasaw, Damson, Japanese, and Stanley), Plumcot, and Prune (fresh and dried). 0.0975 to 0.219 (12.0 to 27.0 fl oz/A NS 0.446 2 Retreatment interval of 7 to 14 days. Do not make more than two applications of a group 9 fungicide within 30 days of harvest.

Gr ound, Drench or Chemigation Fluopyram 500 SC

(4.16 lb ai/gal) [264
- RLGI]
**Stone Fruits** 0.130 to 0.221 lb ai/100 gal/A 4.0 to 6.8 fl oz/100 gal/A NS 0.446 lb ai/A 13.7 fl oz/A 0 Retreatment interval of 5 to 7 days. FLU+TFS SC 500 (2.10 lb ai/gal) [264
- RLGT] 0.0820 to 0.125 lb ai/100 gal/A 5.0 to 7.6 fl oz/100 gal/A 4 0.251 lb ai/A 15.3 fl oz/A 1 Retreatment interval of 7 to 14 days. FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.0821 to 0.125 lb ai/100 gal/A 101 to 154 fl oz/100 gal/A 4 0.251 lb ai/A 309 fl oz/A 1 Retreatment interval of 7 to 14 days. 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.157 to 0.223 lb ai/100 gal/A 6.0 to 8.56 fl oz/100 gal/A NS 0.446 lb ai/A 17.1 fl oz/ 0 Retreatment interval of 5 to 7 days. Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) **Strawberry and Other Low -**  **Growing Berries (except Cranberries):**  Bearberry, Bilberry, Blueberry (Low
-bush), 0.104 to 0.222 (3.2 to 6.84 fl oz/A) NS 0.446 0 Retreatment interval of 7 days.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **35** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  [264
- 1078] Cloudberry, Ligonberry, Muntries, Partridgeberry, and Strawberry. Gr ound or chemigation Propulse

(1.67 lb ai/gal) [264
- 1084] **Low Growing Berry subgroup, except Strawberry and Cranberries:**  Bearberry, Bilberry, Cloudberry, Muntries, Partridgeberry, and cultivars, varieties, and/or hybrids of these. 0.134 (10.3 fl oz/A) NS 0.446 45 Retreatment interval of 7 to 10 days.

Gr ound, aerial or chemigation Luna Sensation

(2.1 lb ai/gal) [264
- 1090] **Strawberry and Other Low -**  **Growing Berries (except Cranberries):**  Bearberry, Bilberry, Blueberry (Low
-bush), Cloudberry, Ligonberry, Muntries, Partridgeberry, and

Strawberry. 0.0660 to 0.125 (4.0 to 7.6 fl oz/A) NS 0.446 0 Retreatment interval of 7 to 14 days. Luna Tranquility (1.04 lb ai/gal) [264
- 1085] **Strawberry and Other Low -**  **Growing Berries (except Cranberries):**  Bearberry, Bilberry, Blueberry (Low
-bush), Cloudberry, Ligonberry, Muntries, Partridgeberry, and

Strawberry. 0.130 to 0.219 (16.0 to 27.0 fl oz/A) NS 0.446 1 Retreatment interval of 7 to 14 days.

Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Sugar beet** 0.222 (6.84 fl oz/A) NS 0.446 7 Retreatment interval of 5 to 7 days. Propulse (1.67 lb ai/gal) [264
- 1084] 0.177 (13.6 fl oz/A) NS 0.446 7 Retreatment interval of 14 days. Luna Sensation (2.1 lb ai/gal) [264
- 1090] 0.0924 to 0.125 (5.6 to 7.6 fl oz/A) NS 0.446 21 Retreatment interval of 10 to 14 days. Tops or greens from this crop may be utilized for food or feed. Gr ound, aerial or chemigation Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Sunflower Subgroup:** Calendula, Castor oil plant, Chinese

tallowtree, Euphorbia, Evening primrose, Jojoa, Niger seed, Rose hib, Safflower, Stokes aster, Sunflower, Tallowwood, Tea oi l plant, Veronia, and cultivars, varieties and/or hybrids of these. 0.222 (6.84 fl oz/A) NS 0.446 14 Retreatment interval of 14 days.
Gr ound, aerial or chemigation Luna Experience

(1.67 lb ai/gal) [264
- 1091] **Sunflower** 0.117 to 0.167 (9.0 to 12.8 fl oz/A NS 0.446 50 Retreatment interval of 14 days. Gr ound, Drench or Chemigation Fluopyram 500 SC

(4.16 lb ai/gal) [264
- RLGI] **Sunflower** 0.221 lb ai/100 gal/A 6.8 fl oz/100 gal/A NS 0.446 lb ai/A 13.7 fl oz/A 14 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.223 lb ai/100 gal/A 8.56 fl oz/100 gal/A NS 0.446 lb ai/A 17.1 fl oz/ 14 Gr ound or Chemigation FLU+TFS SC 500

(2.10 lb ai/gal) [264
- RLGT] **Tree Nuts** 0.0820 to 0.125 lb ai/100 gal/A 5.0 to 7.6 fl oz/100 gal/A NS 0.251 lb ai/A 15.3 fl oz/A 60 Retreatment interval of 7 to 21 days.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **36** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.0821 to 0.125 lb ai/100 gal/A 101 to 154 fl oz/100 gal/A NS 0.251 lb ai/A 309 fl oz/A 60 **Seed Treatment** Seed treatment with commercial slurry mixture equipment only. Luna Privilege

(4.16 lb ai/gal) [264
- 1078] **Peanut** 0.049725 to 0.124475 lb ai/100 lb seed (1.53 to 3.83 fl oz per 100 lb of peanut seeds) 1 0.446 (from all uses) NA Do not use treated seed for food, feed, or oil purposes. **Non Agricultural Use Sites**

Gr ound or Chemigation Fluopyram 500 SC

(4.16 lb ai/gal) [264
- RLGI]

**Turf Grass** : Golf Courses, Sod Farms, Sports Fields, Industrial, Municipal, Commercial, and other Turf Grass areas. 0.0013 to 0.0101 lb ai/1000 ft2 (0.04 to 0.31 fl oz/1000 ft2 ) (0.0566 to 0.439 lb ai/A)

NS 0.3145 fl oz/1000 ft2 13.7 fl oz/A 0.446 lb ai/A

NA Retreatment interval of 7 to 28 days. FLU+TFS SC 500 (2.10 lb ai/gal) [264
- RLGT] 0.000820 to 0.00984 lb ai/1000 ft2 (0.05 to 0.6 fl oz/1000 ft 2 ) (0.0557 to 0.429 lb ai/A) 0.6267 fl oz/1000 ft2 27.3 fl oz/A 0.446 lb ai/A FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.00121 to 0.0102 lb ai/1000 ft2 (1.5 to 12.6 fl oz/1000 ft 2 ) (0.0531 to 0.446 lb ai/A) 12.6 fl oz/1000 ft2 549 fl oz/A 0.446 lb ai/A FLU+TFS SC 32.5 (0.104 lb ai/gal) [264
- RLGA] 0.00121 to 0.0102 lb ai/1000 ft2 (1.5 to 12.6 fl oz/1000 ft 2 ) (0.0531 to 0.446 lb ai/A) 12.6 fl oz/1000 ft2 549 fl oz/A 0.446 lb ai/A 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.0013 to 0.0102 lb ai/1000 ft2 (0.05 to 0.39 fl oz/1000 ft2 ) (0.0566 to 0.444 lb ai/A) 0.393 fl oz/1000 ft2 17.1 fl oz/A 0.446 lb ai/A

Gr ound Fluopyram 500 SC

(4.16 lb ai/gal) [264
- RLGI]
**Residential Turf Grass** 0.0013 to 0.00912 lb ai/1000 ft2 (0.04 to 0.28 fl oz/1000 ft2 ) (0.0566 to 0.396 lb ai/A)
NS 0.2847 fl oz/1000 ft2 12.4 fl oz/A 0.403 lb ai/A
NA Retreatment interval of 7 to 28 days. FLU+TFS SC 500 (2.10 lb ai/gal) [264
- RLGT] 0.000820 to 0.00919 lb ai/1000 ft2 (0.05 to 0.56 fl oz/1000 ft2 ) (0.0557 to 0.400 lb ai/A) 0.5647 fl ozi/1000 ft2 24.6 fl oz/A 0.404 lb ai/A FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.00121 to 0.00926 lb ai/1000 ft2 (1.5 to 11.4 fl oz/1000 ft 2 ) (0.0531 to 0.404 lb ai/A) 11.4 fl oz/1000 ft2 497 fl oz/A2 0.404 lb ai/A FLU+TFS SC 32.5 (0.104 lb ai/gal) 0.00121 to 0.00926 lb ai/1000 ft2 (1.5 to 11.4 fl oz/1000 ft 2 ) 11.4 fl oz/1000 ft2 497 fl oz/A

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **37** of **87 Table**  **3.3 .1. Summary of Proposed Directions for Use of Fluopyram**  **. Application**  **Tim ing, Type,**  **and Equip. Form** **ulation**

**[EPA Reg. No.] Crops**  **Application Rate (lb ai/A)**  **Max. No.**  **Applic. per**  **Season Max. Seasonal** 

**Applic. Rate (lb ai/A)**  **PHI**

**(days) Use Directions and** 

**Lim itations**  [264
- RLGA] (0.0531 to 0.404 lb ai/A) 0.404 lb ai/A 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.0013 to 0.009285 lb ai/1000 ft2 (0.05 to 0.3558 fl oz/1000 ft2 ) (0.0566 to 0.404 lb ai/A) 0.3558 fl oz/1000 ft2 15.5 fl oz/A 0.404 lb ai/A

Gr ound, Drench or Chemigation Fluopyram 500 SC

(4.16 lb ai/gal) [264
- RLGI] **Ornamentals:** in Residential and Commercial Landscapes, Interiorscapes, Field Grown and Container Ornamentals, in Nurseries, and Greenhouses, Lathhouses, Shadehouses, Containers and Other Enclosed Structures. 0.221 lb ai/100 gal/A 6.8 fl oz/100 gal/A

NS 13.7 fl oz/A 0. 446 lb ai/A

NA Retreatment interval of 7 to 21 days. FLU+TFS SC 500 (2.10 lb ai/gal) [264
- RLGT] 0.0164 to 0.131 lb ai/100 gal/A 1.0 to 8.0 fl oz/100 gal/A 27.3 fl oz/A 0.446 lb ai/A Retreatment interval of 7 to 28 days. FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.0163 to 0.130 lb ai/100 gal/A 20 to 160 fl oz/100 gal/A 0.445 lb ai/A 548 fl oz/A Retreatment interval of 7 to 28 days. 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.223 lb ai/100 gal/A 8.56 fl oz/100 gal/A 0.446 lb ai/A 17.1 fl oz/A Retreatment interval of 7 to 21 days.

Gr ound or Chemigation Fluopyram 500 SC

(4.16 lb ai/gal) [264
- RLGI]
**Christmas Trees** 0.221 lb ai/100 gal/A 6.8 fl oz/100 gal/A

NS 13.7 fl oz/A 0.446 lb ai/A

NA Retreatment interval of 7 to 21 days. FLU+TFS SC 500 (2.10 lb ai/gal) [264
- RLGT] 0.220 lb ai/100 gal/A 13.4 fl oz/100 gal/A 27.1 fl oz/A 0.445 lb ai/A FLU+TFS SC 25 (0.104 lb ai/gal) [264
- RLGL] 0.220 lb ai/100 gal/A 271 fl oz/100 gal/A NS 13ESP715 3.3 SC (3.34 lb ai/gal) [432
- RL UG] 0.223 lb ai/100 gal/A 8.56 fl oz/100 gal/A 0.446 lb ai/A 17.1 fl oz/A

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **38** of **87 3.4**  **Anticipated Exposure Pathways** Humans may

be exposed to fluopy

ram in food and drinking water, since fluopy ram may be applied directl y to growing crops and application may result in fluopyram reaching surface and ground water sources of drinking water. In an occupational setting, applic ators may be exposed by the dermal and inhalation routes while handling the pesticide prior to application, as well as during application. There is also a potential for post
- application dermal and inhalation exposure s for workers re
- entering treated field s . Additionally , there are proposed uses of fluopy ram on turf and ornamentals; and therefore, exposure in residential or non
- occupational settings is likely , and will result in short
- term dermal and inhalation exposure s fo r adult handl ers and dermal (for adults and small children) and incidental oral (for small children) exposures from post
application activities. **3.5 Consideration of Environmental Justice**  Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low - Income Populations," (htt p://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf
. As a part of every

pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well
- established procedures. In line with OPP policy, HED estimates risks to population s ubgroups from pesticide exposures that are based on patterns of that subgroup’s food and water consumption, and activities in and around the home that involve pesticide use in a residential setting. Extensive data on food consumption patterns are compiled by the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey , What We Eat in America, (NHANES/WWEIA) and are used in pesticide risk assessments for all registered food uses of a pesticide. These data are anal yz ed and categoriz ed by subgroups based on age and ethnic group. Additionally , OPP is able to assess dietary exposure to smaller, specialized subgroups and exposure assessments are performed when conditions or circumstances warrant. Whenever appropriate, non
- dietary

expos ures based on home use of pesticide products and associated risks for adult applicators and for toddlers, youths, and adults entering or playing on treated areas post - application are evaluated. Further considerations are currentl y in development as OPP ha s committed resources and expertise to the development of specialized software and models that consider exposure to b ys tanders and farm workers as well as lifestyl e and traditional dietary patterns among specific subgroups. **4.0 Hazard Characterization and**  **Dose -**  **Response Assessment** The last comprehensive risk assessment was completed in September, 201 4 (D414231, B. O’Keefe, 09 /2 2 /201 4 )
. The toxicology database is complete and the hazard characterization is unchanged from the last assessment. This assessment includes summaries of prior hazard characterization.

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **39** of **87 4.1**  **Toxicological Effects** L iver effects and d ecreased body weight were the most common and sensitive findings in the subchronic and chronic oral toxicity studies in rats, mice, and dogs. L iver effect s were characterized b y increased liver weight, hepatocellular hypertrophy, hepatocellular vacuolation, increased mitosis and hepatocellular necrosis
. In creased liver tumors were also observed in female rats in the carcinogenicity study . Liver effects in rodents were seen at lower dose levels (as low as 6 mg/kg) than those in the dogs. Thyroid effects were found at dose levels similar to those that produced liver effects in rodents ; effects consisted of follicular cell hy pertrophy, increased thy

roid weight and hy

perplasia . C hanges in thy roid hormon e level s (T 3 

### & T 4 

### ) and increased thy

roid stimulating hormone ( TSH ) were also seen in rats in a subchronic toxicity study
. In male mice, there was an increased incidence of thyroid adenomas. In the genotoxicity battery , fluop yram was shown to have no genotoxic potential. Fluopy ram is not a developmental toxicant, nor did it adversel y affect reproductive parameters. No evi dence of qualitative or quantitative susceptibility w as observed in these studies
. In an acute neurotoxicity

study , transient decreased motor activity was seen only

on the day

of treatment, but no other finding s demonstrating neurotoxicity w ere found. In addition, no neurotoxicity

was observed in the subchronic neurotoxicity study in the presence of other systemic adverse effects. Fluopy ram did not produce treatment
- related effects on the immune system. With oral dosing, fluopy

ram was rapidl y absorbed from the gastro - intestinal ( GI) tract of male and female rats ; the percentage absor bed was approximately 93% of the administered dose. The max imal plasma concentration was reached at 15 h ours in males and 11 h ours in females post dosing (5 mg/kg). The ab sorbed fluop yram was quickly distributed within the central compartments of the body (e.g. blood, liver, and kidney) and showed a distinctive preference towards the liver and to a small er extent to the kidneys. The elimination results showed that 53
- 65% o f administered radioactivity was eliminated via feces and 32
- 41 % was eliminated via the urine. Less than 0.07
- 0.09 % of the administered dose was expired
. After 168 h our s post dosing 91
- 99% of the administered radioactivity was eliminated via urine and feces. Residue anal ys is showed that the highest radioactivity level was found in the liver (0.4 to 1.0% of the administered radioactivity)
. Fluop yram was extensively metab olized and more than 29 metabolites were identified. Three major groups of metabolites were formed in the liver (fluopy ram - 7
- OH
- GA, 8
- OH
- GA and enol
- glucuronic acid) . Bioaccumulation was not observed. Fluopy ram plant metabolites, fluopy ram -py ridyl
- carbox yl ic acid and fluopy ram methyl
sulfoxide, demonstrated less acute toxic potential than the parent compound. Mutagenicity tests on these two metabolites were negative. A parallel approach was used to e stimate the dermal absorption factor in human skin by using a proportional relationship: rat in vivo /rat in vitro = human in vivo /human in vitro
. The dermal absorption values for human skin were calculated to be 0.2% for the neat formulation and 1.9% for the spray

dilution.

### Fluopy

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Page **40** of **87 4.2**  **Safety F**  **actor for Infants and Children (FQPA Safety Factor)** The FQPA safety factor can be reduced to 1x b ecause (1) the toxicology database is complete, (2) there is no evidence of neurotoxicity , (3) there is no evidence of increased susceptibility in the developing or young animals which were exposed during pre
- or post - natal periods, and (4) there are no residual uncertainties in the exposure database. **4.2.1 Completeness**  **o f**  **the Toxicology Database**  The toxic ology

database for fluop yram is complete, and the available studies are adequate to characterize potential pre
- and/or post
- natal risk s for infants and children , and includes acceptable developmental toxicity studies in the rat and rabbit, as well as acute and subchronic neurotoxicity

studies. HED waived the required subchronic inhalation study based on a weight of evidence approach (TXR 0056523, 01/20/2013.) **4.2.2 Evidence of N**  **eurotoxicity** The fluop yram toxicology database did not demonstrate evidence o f neurotoxicity . Although transient decreases in motor and locomotor activities in the acute neurotoxicity study were seen on the day

of treatment and limited use of hind
- limbs and reduced motor activity was seen in the rat chronic/carcinogenicity study , there were no other associated neurobehavioral or histopathology

changes found in other studies in the fluopy ram toxicity

database. The effects seen in the chronic/carcinogenicity study were in the presence of increased mortality and morbidity such as gen eral pallor and emaciated appearance. Therefore, the reduced motor activity and limited use of hind
- limbs seen in these two studies were judged to be the consequence of the s ys temic effects and not direct neurotoxicity
. **4.2.3 Evidence**  **o f Sensitivity/Su**  **sc eptibility in the Developing o**  **r Young Animal** The available developmental toxicity studies in rats and rabbits and the multi
- generation reproduction in rats demonstrate no evidence of increased susceptibility in the developing or yo ung animals which were e xposed during pre
- or post - natal periods. **4.2.4 Residual**  **Uncertainty in the Exposure Datab ase**  There are no residual uncertainties in the exposure database. The acute dietary exposure assessment was performed using conservative exposure inputs, including tolerance level residues for all crops , whereas the chronic dietary assessment included average field trial residue levels for all crops. Both acute and chronic dietary assessments assumed 100% crop treated and incorporated empirical or default processing factors. The dietary exposure assessment also assumed that all drinking water will contain fluopyram at the highest EDWC levels modeled by EFED for ground or surface water. Therefore, it can be concluded that the dietary exposure anal ys is does not underestimate risk from acute and chronic dietary exposure to fluopy

ram. While there is the potential for handler and post
- application residential exposure, the best data and approaches currently available were used in the fluopy ram residential assessment
. The

### Fluopy

ram Human Health Risk Assessment DP No. D421926

Page **41** of **87** Agency used the current conservative approaches for residential assessment, many of which include recent upgrades to the SOPs. The Agency believes that the calculated risks represent conservative estimates of exposure because maximum application rates are used to define residue levels upon which the calculations are based. Therefore, residential exposures are unlikely to be under estimated. **4.3 Toxicity Endpoint and Point of**  **D eparture Selections**  **4.3.1 Dose**  **- Response Assessment**  For fluop yr am, HED has selected the most sensitive and protective endpoints from the database to establish points of departure for the risk assessment (Table 4.5.4.1). For acute oral exposure, an acute neurotoxicity

study in rats has been used to select the dose (50 mg/kg) and endpoint for establishing the aRfD ( 0. 5 mg/kg/day) for the general population. The lowest observable adverse effect level ( LOAEL) of 100 mg/kg is based on decreased motor and locomotor activity in females , an effect attributable to general toxicity
. For chronic dietary exposure, a combined chronic/carcinogenicity s tudy in rats was used to select the dose (NOAEL=1.2 mg/kg/day) and endpoint for establishing the chronic reference dose ( cRfD ; 0.012 mg/kg/day)
. The toxicity endpoint was based on follicular cell hy pertrophy i n the thy

roid and increased liver weight with liver gross pathological and histopathological findings at 6.0 mg/kg/day . The point of departure derived from this study

is protective of the adverse thy roid effects observed in the mouse carcinogenicity

study seen at 105 mg/kg/day
. A 2
- generation reproduction study in rats was used to select the dose (NOAEL = 14.5 mg/kg/day) and endpoint for short
- term incidental oral exposure s . The LOAEL of 82. 8 mg/kg/day was based on c linical chemistry changes, increased kidney weight in parents, and decreased body weight with secondary

decreases in spleen and thy mus weights in the offspring
. This study was also chosen for short
- and intermediate
- term inhalation e xposure scenarios, assuming inhalation and oral absorption equivalency (100%). A 28
- day dermal toxicity

study was used to select the point of departure (NOAEL= 300 mg/kg/day) and endpoint ( ↑ prothrombin time and altered cholesterol levels ) for short
- and intermediate term dermal exposure. **4.3.2 Recommendation for Combining Routes of Exposures for Risk Assessment**  Since the inhalation point of departure is based on an oral study, oral exposures can be combined with inhalation exposures. Common toxicologic al effects w ere not observed at the LOAELs of studies selected for the assessment of short
- and intermediate
- term exposures by the dermal and inhalation routes ; prothrombin time and altered cholesterol levels were the dermal endpoint whereas the inhalation endpoint was based on kidney , spleen and thy mus effects accompanied b y clinical chemistry and body weight changes. Therefore, it is not appropriate to combine these routes of exposure for risk assessment.

### Fluopy

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Page **42** of **87 4.3.3**  **Cancer Classification and Risk Assessment Recommendation**  The CARC classified fluopy ram as “Not Likel y to be Carcinogenic to Humans” at doses that do not induce cellular proliferation in the liver or thyroid glands . This classification was base d on convincing evidence that non - genotoxi c mode s of action for liver tumors in rats and thyroid tumors in mice have been established and that the carcinogenic effects have been demonstrated as a result of a mode of action dependent on activation of the CAR /PXR receptors (CARC Report, May

8, 2014)
. The CARC has determined that quantification of risk is not required. There is sufficient data to ascertain the mode of action of fluopy ram. The chronic Reference Dose (RfD) is derived using the NOAEL of 1.2 mg/kg/day as the “point of departure” which is below the dose of 11 mg/kg/day

that caused cell proliferation in the liver (i.e., a key event in tumor formation) and the subsequent liver tumors at a higher dose (89 mg/kg/day). Additionally , there is no con cern for mutagenicity
. **4.3.4 Summary of P**  **oints of Departure and Toxicity Endpoints Used in Human Risk Assessment**  **Table 4 .**  **3 .**  **4. 1**  **. Summ**  **ary of Toxicological Doses and Endpoints for Fluopyram**  **for Use in Dietary and Non**   ** Occupational Hum** **an Health Risk Assessments .**  **Exposure/ Scenario**  **Point of**

**Departure Uncertainty/FQPA** 

**Safety Factors RfD, PAD,** 

**Level of Concern for**  **Risk Assessment**  **Study and Toxicological Effects**
Ac ute Dietary (General Population, including Infants and Children) NOAEL=

50 mg/kg/day UF A= 10 X

UF H=10 X FQPA SF=1 X Ac ute RfD =

0. 50 mg/kg/day aPAD = 0. 50 mg/kg/day Ac ute Neurotoxicity Study in Rats.

The LOAEL of 100 mg/kg in females is based on decreased motor and locomotor activity in females. The LOAEL in males wa s 125 mg/kg/day. Ac ute Dietary (Females 13
- 49 years of age) An endpoint attributable to a single dose exposure has not been identified for this subpopulation
.

Chronic Dietary (All Populations) NOAEL=

1.2 mg/kg/day UF A= 10 X

UF H=10 X FQPA SF=1 X Chronic RfD

= 0.0 12 mg/kg/day cPAD = 0.0 12 mg/kg/day Com

bined Chronic/Carcinogenicity in Rats The LOAEL of 6.0 mg/kg/day is based on follicular cell hypertrophy in the thyroid, and increased liver weight with gross pathological and histopathological findings. Incidental Oral Short
- Term (1
- 30 days) and Intermediate
Term (1
- 6 mo nths) NOAEL=

14.5 mg/kg/day UF A= 10 X

UF H=10 X FQPA SF=1 X Residential

LOC for MOE = 100 Reproduction study in rats

The LOAEL of 82.8 mg/kg/day is based clinical chemistry changes and increased kidney weight in parents, and decreased body weight and body weight gain with decreases in spleen and thymus weights in offspring
.

### Fluopy

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Page **43** of **87 Table 4**  **. 3**  **. 4.**  **1 .**  **Summ ary of Toxicological Doses and Endpoints for**  **Fluopyram for Use in Dietary and Non**  **** **Occupational Hum an Health Risk Assessments**  **. Exposure/**  **Scenario Point of** 

**Departure Uncertainty/FQPA** 

**Safety Factors RfD, PAD,** 

**Level of Concern for**  **Risk Assessment**  **Study and Toxicological Effects**
Dermal Short
Term (1
- 30 days) and Intermediate
Term (1
- 6 mo nths) NOAEL=

300 mg/kg/day UF A= 10 X

UF H=10 X FQPA SF=1 X Residential

LOC for MOE = 100 A 28
- day dermal study in rats The LOAEL of 1000 mg/kg/day is based on increased cholesterol (F), increased prothrombin time (M). Inhalation Short
- Term (1
- 30 days) and Intermediate
Term (1
- 6 mo nths) NOAEL=

1 4 .5 mg/kg/day UF A= 10 X

UF H=10 X FQPA SF=1 X Residential

LOC for MOE = 100 Reproduction study in rats

The LOAEL of 82.8 mg/kg/day is based clinical chemistry changes and increased kidney weight in parents, and decreased body weight and body weight gain with decreases in spleen and thymus weights in offspring
. Cancer (oral, dermal, inhalation) The CARC has classified fluopyram as “Not Likely to be Carcinogenic to Humans” at doses that

do not induce cellular proliferation in the liver or thyroid glands and determined that quantification of c ancer risk is not required. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose
- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. **Table 4. 3**  **. 4**  **.2 Summary of Toxicological Doses and Endpoints for**  **Fluopyram for Use in Occupational Hum**  **an Health Risk Assessments**  **. Exposure/**  **Scenario Point of** 

**Departure Uncertainty** 

**Factors Level of Concern** 

**for Risk Assessment**  **Study and Toxicological Effects** Dermal Short
Term (1
- 30 days) and Intermediate
Term (1
- 6 mo nths) NOAEL=

300 mg/kg/day UF A= 10 X

UF H=10 X Occupational

LOC for MOE = 100 A 28
- day dermal study in rats The LOAEL of 1000 mg/kg/day is based on increased cholesterol (F), increased prothrombin time (M). Inhalation Short
- Term

(1
- 30 days) and Intermediate
term (1
- 6 mo nths) NOAEL=

1 4 .5 mg/kg/day UF A=10 X

UF H=10 X Occupational

LOC for MOE = 100 A 2
- generation reproduction study in rats.

The LOAEL of 82.8 mg/kg/day is based clinical chemistry changes and increased kidney weight in parents, and decreased body weight and body weight gain with decreases in spleen and thymus weights in offspring Cancer (oral, dermal, inhalation) The CARC has classified fluopyram as “Not Likely to be Carcinogenic to Humans” at doses that

do not induce cellular proliferation in the liver or thyroid glands and has determined that quantification of cancer risk is not required. Point of Departure (POD) = A data point or an estimated point that is derived from observed dose
- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human

### Fluopy

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Page **44** of **87** exposures. NOAEL = no ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). MOE = margin of exposure. LOC = level of concern. N/A = not applicable. 

### 5.0 **Dietary Exposure and Risk Assessment 5.1**  **Residues of Concern Summary and Rationale** The nature of the residue in plants is adequatel y understood based on metabolism studies with grape, potato, bean, and red pepper (D387587, L. Cheng, 02/23/2011) and with wheat seed treatment (D420271, S. Funk, 05/20/2014). The nature of the residue in ro tational crops is adequatel y understood based on confined rotational crop studies with rotated Swiss chard, turnip, and wheat. The metabolic pathway of fluopy ram is similar in primary

and rotational crops, and mainly involves hydrox ylation of parent compound leading to AE C656948
- 7
- hydrox y and AE C656948
- 8
- hydroxy , conjugation of the hydrox yl ated parent compound, mainly with sugars, and cleavage of the molecule leading to AE C656948
- benzamide, AE C656948
-py ridyl
- acetic acid (AE C656948
- PAA), and AE C656948
-py ridyl
- carbox yl ic acid (AE C656948
- PCA). HED has determined that the residue of concern in plant commodities (primary and rotational crop) for tolerance enforcement is fluopy ram, and for risk assessment is fluopy ram in all crops except in legumes and oi lseed crops where AE C656948
-benzamide is also included. The nature of the residue in livestock is adequately understood based on metabolism studies with goats and hens (D387587, L . Cheng, 02/23/2011). Metabolism of fluopy ram in livestock mainly involve s hydrox yl ation of the parent compound to AE C656948
- 7
- hydrox y and AE C656948
- 8
- hydrox y, elimination of water from compounds hydroxyl ated in the ethylene bridge leading to AE C656948
- Z/E
- olefines, cleavage of the molecule leading to AE C656948
-benzamide and AE C656948
- PAA, and conjugation of the hydrox yl ated parent compound, mainly with glucuronic acid. For tolerance enforcement, HED has determined that the residues of concern are fluop yram and AE C656948
-benzamide. For risk assessment, the residues of co ncern in ruminants are fluopy ram and its metabolites AE C656948
-benzamide, AE C656948
- E
- olefine, AE C656948
- Z
olefine and AE C656948
- 7
- hydrox y, and in hens are fluop yr am and its metabolites AE C656948
- benzamide, AE C656948
- E
- olefine, and AE C656948
- Z
- olefine. A summary of m etabolites and degradates to be included in the risk a ssessment and tolerance e xpressions is presented in Table 5.1. **Table 5.1. Summary of Metabolites and Degradates to be included in the Risk Assessment and Tolerance Expressions.**  Matrix Risk Assessment Tolerance Expression
Plants Primary

Crop Fluopyram

(Fluopyram + benzamide for legumes and oil seed crops) Fluopyram Rotational Crop Fluopyram

(Fluopyram + benzamide for legumes and oil seed crops) Fluopyram Livestock Ruminant Fluopyram + benzamide + 7
- OH
- fluopyram + olefins (E, Z) Fluopyram + benzamide

### Fluopy

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Page **45** of **87 Table 5.1. Summary of Metabolites and Degradates to be included in the Risk**  **Assessment and Tolerance Expressions.** Matrix Risk Assessment Tolerance Expression Poultry Fluopyram + benzamide + olefins (E, Z) Fluopyram + benzamide Drinking Water Fluopyram Not Applicable 

### 5 **.2 Food**  **Residue Profile**  The crop field trials are adequate for tolerance assessment and for risk assessment. Residues were quantifiable in all cases except sweet corn. The previousl y reviewed cotton, peanut, and so ybean processing study showed no concentration of fluopy ram in oil and meal. The canola and sunflower processing studies showed that fluopy ram did not concentrate in meal or refined oil. The benzamide metabolite did not concentrate in meal or oil. Fluopy ram residues concentrate on apple wet pomace, corn bran, o range oil, potato wet peel, raisin, dried tomatoes, dried peaches, sugar beet (dried and refined sugar) , wheat bran and wheat germ. Existing storage stability

study data are adequate to support the intervals of frozen storage of all raw agricultural and processed commodities from the proposed uses. No corrections for degradation during storage are needed. The livestock diets were revised using the recommended crop field trial data. Exposures increased from 0.38 ppm for beef cattle, 1.2 ppm for dairy cattle, 0.083 ppm for poultry , and 0.082 ppm for swine to 3.58 ppm for beef cattle, 24.8 ppm for dairy cattle, 0.36 ppm for poultry , and 0.39 ppm for swine. **5.3 Water Residue Profile**  The drinking water residues used in the dietary risk assessment were provided by the EFED (D427985 M , A. Ruhman, 10/26/2015 )
. The residue of concern in drinking water for this single chemical risk assessment is fluopy ram, (Residues of Concern Knowledge
-base Subcommittee [ROCKS] , D367115, 07/16/2009). The EFED estimated surface water and ground water residues for fluopy

ram using the surface water concentration calculator (SWCC) and PRZM
- GW model, respectivel y. The EDWCs includes all new uses and currentl y registered uses. The drinking water models and their descriptions are available at the EPA internet site: http://www.epa.gov/oppefed1/models/water/
. For surface water EDWCs, the peak value is 50.6 ppb and the chronic (non
- cancer) value is 1 7 .3 ppb.

### Fluopy

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Page **46** of **87** For ground water, the highest acute ground water EDWC is 97.6 ppb of parent fluopy ram and the chronic value is 90.5 ppb of parent fluop yr am. Ground water EDWCs are used in the dietary assessment, since they

were higher than those for surface wate r. For the human health risk assessment, the highest relevant EDWCs are recommended. **Table 5.3 .**  **Estim ated Surface and Ground**  **W at**  **er Concentrations for Fluopyram .**  **Scenario Surface Water Conc., ppb**  **Ground Wa**  **ter Conc., ppb** Ac ute 

### 50.6 **97.6 a**  Chronic (non
- cancer) 

### 17.3 **90.5 a**  Chronic (cancer) 

### 11.0 NA

a Bold values were used in the dietary assessment. 

### 5.4 **Dietary Risk Assessment 5.4.1**  **Description of Residue Data Used in Dietary Assessment** The acute dietary

anal ys is i s an unrefined conservative assessment that included tolerance residue levels, the assumption of 100% crop treated , and processing factors (empirical and default) . The EDWC was incorporated directl y into the acute dietary assessment ( ground water EDWC of 97.6 ug/L) and was calculate d by PRZM
- GW modeling. The chronic dietary

analysis i s a refined assessment that included average residue level s, % crop treated, and processing factors (empirical and default)
. The EDWC from PRZM
- GW modeling was incorporated directly into the chronic dietary assessment ( ground water EDWC of 90.5 μg/L)
. **5.4.2 Percent Crop Treated Used in Dietary Assessment**  The acute dietary

exposure anal ys is assumed that 100% of the proposed crops were treated with fluopy ram. The Biological and Economic Analysis Division (BEAD) has provided updated percent crop treated data for new uses (PCTn) for fluop yram (DP# 427397, 0 9 /2 2/201 5) , which includes both average and maximum PCT values . In addition, the previous PCTn (2010 and 2011) were considered acceptable (DP# 370371 (2010); DP# 381225 (2011); DP# 387 227 (2011)
. The following average percent crop treated estimates were used in the chronic dietary risk assessment for the following crops that are currently registered/proposed for fluopy ram: potatoes 64%; sugar b eets 48%; celery 60%; head lettuce 67%; leaf lettuce 62%; spinach 43% (BEAD recommends using USDA/NASS spinach PCT values a s a prox y for Brassica leafy vegetables and leafy

vegetables) ; broccoli 24%; snap beans 44%; dry beans/peas 7%; soy

beans 17%; fresh tomatoes 64%; processed tomatoes 57%; cantaloupes 22%; cucumbers 41%; pumpkins 45%; squash 47%; watermelons 54%; oranges 39%; apples 40%; pears 43%; peaches 56%; grape wine 79% (used for grape, wine and sherry); strawberries 75%; almonds 33%; corn

### Fluopy

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Page **47** of **87** field 9%; corn, sweet 50%; wheat 17% (from spring wheat at 17% and winter wheat at 6% ) ; peanuts 67%; blueberries 54%; and blackberries 55%. **5.4.3 Acute Dietary Risk Assessment**  Estimated acute dietary

exposure to fluopy

ram from food and drinking water for all population subgroups is below 100% of the acute Population Adjusted Dose (aPAD). Combined dietary exposure from food and drinking water at the 95 th 

### percentile of exposure is estimated to be 0.096117 mg/kg/day

for the overall U.S. population, equivalent to 19% of the aPAD. The population subgroup with the highest estimated acute dietary exposure to fluopy

ram is children 1
- 2 years old , with an estimated exposure at the 95 th 

### percentile of 0.175170 mg/kg/day , equivalent to 3 5 % of the aPAD. HED is concerned wh en estimated dietary risk exceeds 100% of the aPAD (see Table 5.4.6). **5.4.4 Chronic Dietary Risk Assessment**  Estimated chronic dietary exposure from food and drinking for all population subgroups is below 100% of the chronic Population Adjusted Dose (cPAD). Combined dietary exposure from food and drinking water is estimated to be 0.003703 mg/kg/day for the general U.S. population, equivalent to 31 % of the cPAD. The population subgroup with the highest estimated chronic dietary exposure to fluopy

ram is children 1 to 2 years old , with an estimated exposure of 0.009733 mg/kg/day , equivalent to 8 1 % of the cPAD. HED is concerned when estimated dietary risk exceeds 100% of the cPAD (see Table 5.4.6). **5.4.5 Cancer Dietary Risk Assessment**  The CARC classified fluopy ram as “Not Likel y to be Carcinogenic to Humans”
. Therefore, a cancer dietary exposure analysis is not required. **5.4.6 Summary Table**  **Table 5.4.6. Summary of Dietary (Food & Drinking Water)**  **Exposure and Risk for Fluopyram**
**Population Subgroup Acute Dietary**  **(95th Percentile) Chronic Dietary**  **Dietary Exposure (m** **g/k g/day)**  **% aPAD Dietary Exposure**  **(m g/k** **g/day) % cPAD**  General U.S. Population 0.096117 19 0.003703 31 All Infants (< 1 year old) 0.137520 28 0.007331 61 **Children 1 -**  **2 years old 0.175170**  **35 0.009733**  **81** Children 3
- 5 years old 0.160828 32 0.006787 56 Children 6
- 12 years old 0.092779 19 0.004079 34 Youth 13
- 19 years old 0.073266 15 0.002617 22

### Fluopy

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Page **48** of **87 Table 5.4.6. Summary of Dietary**  **(Food & Drinking Water) Exposure and Risk for Fluopyram** 
**Population Subgroup Acute Dietary**  **(95th Percentile) Chronic Dietary**  **Dietary Exposure (m** **g/k g/day)**  **% aPAD Dietary Exposure**  **(m g/k** **g/day) % cPAD**  Adults 20
- 49 years old 0.088800 18 0.003324 28 Adults 50+ years old 0.091387 18 0.003315 28 Females 13
- 49 years old 0.092231 18 0.003256 27 **1** The population subgroup with the highest estimated acute and chronic dietary (food + drinking water) exposure and risk is indicated by bold text. 

### 6.0 **Residential (Non -**  **Occupational) Exposure/Risk Characterization** Based on the proposed product labels, several products are intended for use by homeowners, or by occupational handlers in residential settings. Therefore, non
- occupational/residential risk assessments have been completed. **6.1 Residential Handler Exposure**  The quantitative exposure/risk assessment developed for residential handlers is based on the re sidential handler scenarios of mixing, loading, and applying liquid formulations to gardens, ornamentals, fruit trees, and turf by manuall y pressurized handwand , hose
- end sprayers , backpack , or sprinkler cans
. Short
- term dermal and inhalation exposures were assessed for residential handlers. All residential handler risk estimates are not of concern to HED (all MOEs ≥100), with MOEs ranging from 8,900 to 190,000 for dermal exposures and 260,000 to 130,000 for inhalation exposures. Summaries of the short
- term risk estimates for residential handlers are included in Appendix D , Table D .1. **6.2 Residential Post** **- application Exposure**  There is the potential for post
- application exposure to fluopy ram for individu als exposed as a result of being in an environment that has been previously treated with fluop yr am. The quantitative exposure/risk assessment for residential post
- application exposures includes the following scenarios:

 Adults and children (1 to < 2 years old) dermal exposure to treated turf during high contact lawn activities,  Children (1 to < 2 years old) incidental oral exposure as a result of contacting treated turf,  Adults and youths (11 to <16 y r old) dermal exposure to treated turf during mowing and golfing activities,  Children (6 to < 11 years old) dermal exposure to treated turf during golfing activities, and  Adults and children (6 to < 11 years old) dermal exposure to treated gardens.

### Fluopy

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Page **49** of **87** Exposures are expected to be short
- term in duration. Short
- term dermal and incidental oral exposure and risk estimates have been assessed. The exposure assessment for dermal exposure to treated gardens is protective of exposure to treated ornamental and fruit trees. Turf Transferable Residue ( TTR ) data for Fluopyram Because turf transferable residue data were not available for fluop yr am, turf residues were estimated using default assumptions. A TTR study is not required for fluopyram at this time. Refer to Section 9.2. 1 of this document for a detailed rationale. Dislodgeable F

oliar R esidue (D

FR ) data for Fluopyram Because dislodgeable foliar residue data were not available for fluopy ram, foliar residues were estimated using default assumptions. A DFR study is not required for fluopy ram at this time. Refer to Section 9.2. 1 of this document for a detailed rationale. Combining Exposure and Risk Estimates HED combines risk values resulting from separate routes of exposure when it is likely they can occur simultaneousl y based on the use pattern and the behavior associated with the exposed population, and if the hazard associated with the points of departure is similar across routes. Since dermal and incidental oral exposure routes do not share a co mmon toxicological endpoint for fluop yram, risk estimates have not been combined for those routes. Summaries of the short
- term risk estimates for residential post - application exposures are included in Appendix D , Tables D .2 through D .4. Table s D .2 and D .3 summarize the residential post
- application exposure and risk estimates for exposures to treated lawns and turf. The proposed liquid formulations do not lead to post
application risk estimates of concern. Residential dermal post
- application MOEs for all life stages range from 1,000 to 97,000. Residential incidental oral post
- application MOEs for children 1 to <2 ye ars old range from 2,400 to 1,100,000. Table D .4 summarizes the residential post
- application exposure and risk estimates for exposures to treated gardens, ornamental trees and shrubs, and fruit trees. The proposed liquid formulations do not lead to post
- application risk estimates of concern (all MOEs ≥100). Residential dermal post
- application MOEs for all life stages range from 2,100 to 33 ,000. **6.3 Residential Risk Estimates for Use in Aggregate Assessment**  The most conservative residential handler or post - application risk estimates should be used in the aggregate risk assessment
. The residential exposures that are recommended for use in the aggregate assessment for fluopy ram are as follows:

 The recommended residential exposure for use in the adult aggregate assessment reflects dermal post
- application exposure to treated lawns from high contact activities.  The recommended residential exposure for use in the children (11 to <16 ye ars old) aggregate assessment reflects dermal post
- application exposure from golfing.  The recommended residential exposure for use in the children (6 to <11 years old)

### Fluopy

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Page **50** of **87** aggregate assessment reflected dermal post
- application exposure to treated gardens.  The recommended residential exposure for use in the children (1 to <2 years old) aggregate assessment reflects dermal post
- application exposure to treated lawns from high contact activities. The residential risk e stimates from these exposures are presented in Table 6.3.1. **Table 6**  **. 3**  **.1. Recommendations for the Residential Exposures for the Fluopyram Aggregate Assessment.**  **Lifestage Dose**  **(m g/k** **g/day) 4**  **MOE 5**  Adults [inhalation handler exposure from treating lawns by hose
- end sprayer] 0. 000056 260, 000 Child (1 to <2 years old) [incidental oral hand
- to - mouth post
- application exposure to treated lawns] 0. 00615 2 , 4 00 

### 6. **4 Residential Bystander**  **Post -**  **application Inhalation Exposure**  Volatilization of pesticides may be a source of post
- application inhalation exposure to individuals nearb y pesticide applications. The agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientifi c Advisory

Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 (http://www.regulations.gov/#!documentDetail;D=EPA
- HQ
- OPP
- 2009
- 0687
- 0037 ). The agency

has evaluated the SAP report and has developed a Volatilization Screening T ool and a subsequent Volatilization Screening Analysis (http://www.regulations.gov/#!docketDetail;D=EPA
- HQ
- OPP
- 2014
- 0219). During Registration Review, the Agency

will utilize this analysis to determine if data (i.e., flux studies, route
- specific inhalatio n toxicological studies) or further anal ys is is required for fluopy ram. In addition to this screen, the Agency has developed a preliminary bystander volatilization inhalation exposure assessment for fluop yram utilizing the currently available inhalation toxicity and air monitoring data. **6. 5**  **Non -**  **Occupational Spray Drift**  **Exposure and Risk Estimates** Spray drift is a potential source of exposure to those nearby pesticide applications. This is particularl y the case with aerial application, but, to a lesser extent, spray drift can also be a potential source of exposure from the ground application methods (e.g., groundboom and airblast) emplo yed for fluopyram **.** The agency has been working with the Spray Drift Task Force (a task force composed of various regis trants which was developed as a result of a Data Call
- In issued by EPA), EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the agency ’s Spray Drift website at http://www2.epa.gov/reducing
-pesticide
- drift for more information)
. The agency has also developed a policy

on how to appropriatel y consider spray drift as a potential source of exposure in risk a ssessments for pesticides. The potential for spray drift will be quantitatively evaluated for each pesticide during the Registration Review process which ensures that all uses for that pesticide will be considered concurrentl y. The approach is outlined in the revised (2012) Standard Operating Procedures For Residential Risk Assessment (SOPs)

- Residential Exposure

### Fluopy

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Page **51** of **87** Assessment Standard Operating Procedures Addenda 1: Consideration of Spray Drift. This document outlines the quantification of indirect non
- oc cupational exposure to drift. **7.0 Aggregate Exposure/Risk Characterization**  In accordance with the FQPA, HED must consider and aggregate (add) pesticide exposures and risks from three major sources: food, drinking water, and residential exposures. In an ag gregate assessment, exposures from relevant sources are added together and compared to quantitative estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated. When aggregating exposures and risks from various sources, HED consi ders both the route and duration of exposure. There is potential acute and chronic exposure via the diet (food and drinking water). Additionally , there are p roposed residential uses so short
- term residential exposures are likel y to occur ; and therefore, short
- term aggregate risks were assessed. **7.1 Acute Aggregate Risk**  The aggregate acute risk estimates include exposure to residues of fluop yram in food and drinking water, and does not include dermal, inhalation , or incidental oral exposure. As demonstrated under section 5.4.3, acute aggregate risks are not of concern. **7.2 Short** **- Term Aggregate Risk**  There is potential short
- term exposure to fluopy ram via dietary

(which is considered background exposure) and residential (which is considered primary) exposure pathways. For children 6 to <11 years old and youths 11 to <16 years old, these pathways lead to exposure via oral (background) as well as dermal (primary) routes. For adults, these pathways lead to exposure via oral (background) as well as dermal and inhalation (primary) routes. The most conservative scenarios were chosen for each. For a description of the residential exposure scenarios considered in the aggregate assessment, see Section 6.3. The short
- term aggregate MOE s for small children and for adults are both 1,500 , and are therefore not of concern to HED (see Table 7.2.1)
. **Table 7.2.1. Short** **- Term**  **Aggregate Risk Calculations**
**Lifest age**  **Residential Exposure Scenario NOAEL**  **mg/kg/day LOC**  **1 Max**  **Exposure 2**  **Residential**

**Exposure mg/kg/day**  **Average**

**Dietary Exposure**  **mg/kg/day Total** 

**Exposure mg/kg/day**  **Aggregate**

**MOE 2**  Child 1 to <2 yr I nc idental oral hand
- to - mo uth post
- application exposure to treated lawns 14.5 100 0.145 0.000056 0.009733 0.009789 1,500 Adult I nhalation handler exposure from treating lawns by hose
- end sprayer 14.5 100 0.145 0.00615 0.003324 0.009474 1,500 1 The Level of Concern MOE is 100. 2 Maximum Exposure (mg/kg/day) = NOAEL/LOC MOE 3 Aggregate MOE = [NOAEL ÷ ( Ave rage Dietary Exposure + Residential Exposure)] 

### 7.3 **Chronic Aggregate Risk** Chronic exposure from the residential pathway is not anticipated based on the current fluopy ram use pattern. The chronic aggregate risk (food and drinking water) is below HED’s LOC (i.e.,

### Fluopy

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Page **52** of **87** <100% cPAD for the general U.S. population and all population subgroups )
. See Section 5.4.4 for details. **8.0 Cumulative Exposure/Risk Characterization**  Unlike other pesticides for which EPA h as followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxici ty finding as to fluopy ram and any other substances and fluop yr am does not appear to produce a toxic metabolite produced b y other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that fluopy ram has a common mechanism of toxicity with other substances. For information regarding EPA’ s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by

EPA’s Office of Pesticide Programs concerning common mechanism determinations and pro cedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/. **9.0 Occupational Exposure/Risk Characterization**  This document presents an assessment of the proposed uses of fluop y ram on numerous agricultural field crops, turf grass, ornamentals, and Christmas trees, and seed treatment to peanuts. Refer to Table 3.3.1 for a detailed description of the proposed uses. Based on application rates and label information, only short
- and intermediate
- term exposures are expected for occupational handlers and post
- application workers. Long
- term exposure is not expected for the proposed use patterns. **9.1 Short** **- /Intermediate**  **- Term**  **Handler Risk** Based on the anticipated use patterns and propo sed labeling, types of equipment and techniques that can potentially

be used, occupational handler exposure is expected from the proposed uses. The quantitative dermal and inhalation exposure/risk assessment developed for occupational handlers is based on the following scenarios: 1) Mixing/loading liquids for aerial and chemigation application, 2) Mixing/loading liquids for groundboom application, 3) Mixing/loading liquids for airblast application, 4) Applying sprays via aerial equipment, 5) Applying sprays via groundboom equipment, 6) Applying sprays via airblast equipment, 7) Flagging for aerial sprays, 8) Mixing, loading, and applying liquids with manually pressurized handwand, 9) Mixing, loading, and applying liquids with mechanically
-pressurized handgun, and 10) Mixing, loading, and applying liquids with a backpack. The proposed labels require occupational handlers to wear the following attire and PPE: long sleeved shirts, long pants, shoes, socks, and chemical resistant gloves. However, the FLU+TFS SC 32.5 and FLU+TFS SC 25 labels do not require the use of gloves.

### Fluopy

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Page **53** of **87** For all exposure scenarios the risk estimates do not exceed HED’s LOC (i.e., MOEs ≥100) at baseline (i.e., long sleeved shirt, long pants, shoes plus socks, without gloves or a respirator). The MOEs ranged from 410 to 1,500,000 for dermal exposure at baseline, 2,400 to 1,100,000 for dermal exposure with the addition of gloves, and 7,400 to 30,000,000 for inhalation exposure. Refer to Appendix E , Table E
. 1 , for the summary of occupational handler risk estimates. The proposed seed treatment o f peanuts is on the Luna ® 

### Privilege label (4.16 lb ai/gal) [EPA Reg. No. 264
- 1078] , which requires water proof gloves for seed treatment activities and no gloves for baggers and bag sewers. For seed treatment use on peanut seeds, the quantitative exposure/risk assessment developed for occupational handlers is based on the following scenarios: 1) Mixing/loading liquids for commercial seed treatment; 2) Bagging treated seed; 3) Sewing bags; 4 ) Multiple activities; and 5) Planting treated seed. Risk estimates for dermal and inhalation short
- term occupational handler exposures all resulted in MOE s ≥100, and therefore, do not exceed HED’s level of concern, with MOEs ranging from 1, 4 0 0 to 9,200 f or dermal exposures and from 1,700 to 17 ,000 for inhalation exposures. Refer to Appendix E , Table E .2. **9.2 Short** **- /Intermediate**  **- Term**  **Post -**  **Application Risk**  HED uses the term post
- application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re
entry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, including activities related to crop production, such as scouting for pests or harvesting. Post
- application exposure levels vary over time and depend on such things as the ty pe of activity , the nature of the crop or target that was treated, the ty pe of pesticide application, and the chemical’s degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatl y reduce the potential for post
- application exposure. **9.2.1 Dermal**  **Post -**  **application Risk**  The post
- application dermal exposure and risk estimates as sociated with agricultural crops, Christmas trees, and nursery ornamentals are summarized in Appendix E , Table E .4
. For each crop or crop group the post
- application activities with the highest transfer coefficient and highest exposure contact are presente d. Short
- and intermediate
- term dermal post
- application exposures and risks to occupational workers were estimated using standard values established by HED since no chemical
- specific data were submitted. The transfer coefficients (TC) used for all post
a pplication activities were the TCs established b y the Science Advisory Council for Exposure Policy Number 3.1 (http://www.epa.gov/pesticides/science/exposac_policy3.pdf). This policy reflects adoption of all Agricultural Re
- Entry Task Force (ARTF) data. Use of the data in this policy requires compensation to the ARTF under FIFRA. The transfer coefficients (TCs) used in this assessment were taken from the Agency ’s revised Agricultural Transfer Coefficient SOP. Many of the TCs in this SOP are based on work of the ARTF. The occupational post
- application MOEs for all crops and crop groups and scenarios do not exceed HED’s level of concern (MOEs ≥100) on day

0 (i.e., 12 hours following application) with dermal MOEs ranging from 250 to

### Fluopy

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Page **54** of **87** 23,000. All other scen arios involving lesser contact activities would have higher MOEs and are also not of concern. For use on cotton, HED has also assessed the post
- application dermal exposure and risk estimates for workers involved in harvesting cotton bolls. Although most of cotton harvesting is done mechanicall y, there are still some activities, with the potential for exposure, that are associated with the harvesting of cotton. The anticipated post
- application activities and dermal transfer coefficients for these activiti es are presented in Appendix E , Table E
. 5
. The recommended transfer coefficients are derived from EPA’s Science Advisory Council for Exposure (ExpoSAC) Policy 3 (http://www.epa.gov/pesticides/science/exposac
-policy3
- march2013.pdf

). No chemical specific data are available for the amount of residue available on the cotton bolls; i.e., dislodgeable boll residue (DBR) data. Such data are available from a study with the active ingredient tribufos; i.e., MRID 42701601. **Note to RD: These data may be proprietary, and subject to the data protection provisions of FIFRA, and therefore, may**  **trigger a data compensation issue between registrants.** Since the proposed fluopy ram labels include a 30 day

pre - harvest interval, the best fit residue data used from MRID 42701601 was chosen from 30 days after harvest and then adjusted for the difference in application rates. All of the cotton harvesting activities resulted in MOEs ranging from 3,100,000 to 17,000,000, which do not exceed the LOC, and are therefore not of concern; see Appendix F, Table F.6
. For use on turf, the exposure/risk assessment for the proposed uses results in a post
- application occupational MOE of 9,000, which is above the dermal LOC (MOE ≥100); and therefore is not of concern; see Appendix E , Table E .7
. Dislodgeable Foliar Residues: There were no chemical
- specific dislodgeable foliar residue data to assess post
- application risks to workers while performing tas ks related to crops treated with fluop yr am . For agricultural crops, occupational post
- application exposures and risks were assessed using HED’s default assumptions that 25% of the initial application is available for transfer on day 0 (i.e., 12 hours after application) and that the residue dissipates at a rate of 10% per day
. In accordance with 40 CFR §158, DFR data are required for all occupational (e.g., crop, nursery , greenhouse use sites) or residential (e.g., ornamental and vegetable gardens, pick your own farms, retail tree farms) uses that could result in post
- application exposure to foliage. In the absence of chemical
- specific DFR data, EPA uses default values. The 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment includes an analysis of a number of DFR studies, which resulted in the selection of a revised default values for the fraction of the application rate available for transfer after a foliar application (F AR

### ). These values are based on an anal ys is of 19 DFR studies. Since that time, the Agricultural Re
- entry Task Force has submitted information (MRID 49299201) that corrects an application rate error made in the original submission of “ARF039

– Determination of Dermal and Inhalation Exposure to Reentry Workers During Chrysanthemum Pinching in a Greenhouse” (EPA MRID 45344501). As a result, the range of F AR 

### values was revised from 2%
- 89% to 2%
- 47%. In the data, a large range of transferability

is observed and this variability can potentiall y be attributable to many factors such as active ingredient; formulation; field conditions in the studies; weather conditions (e.g., humidity); or many other difficult to quantify factors. Although witnessed across multipl e

### Fluopy

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Page **55** of **87** chemicals, this range in F AR 

### values is not expected when considering DFR data for a single chemical. At this time, the ARTF submission did not alter the selection of 25% as the reasonable, high
- end default value. Because DFR data are not available for fluopy ram, EPA is using the default value of 25%. Although there may be a small degree of uncertainty in the use of the default DFR value for fluop yram (i.e., there is a small chance that the F AR 

### value may exceed the applicable default value ), it is likel y that the health
-protective aspects of EPA’s occupational post
- application assessment methodology will more than compensate for this potential uncertainty. For example, when assessing residential and occupational post application exposure to gardens and ornamentals, EPA assumes the following: exposures occur to zero - day

(i.e., day of application ) residues every day of the assessed exposure duration (i.e., EPA assumes that no dissipation or degradation occurs, it doesn’t rain, etc); individuals perform the same post - application activities performed in the transfer coefficient study day after day (e.g., weeding, harvesting, pruning, etc.); and individuals engage in these post
- application activities for a high
- end amount of time every day (represented by

data reflecting time spent gardening based on survey data). Given the conservatisms discussed above and the potential compounding nature of these conservatisms, EPA is able to rely upon the calculated exposure estimates with confidence that exposure is not being underestimated. Since the highest estimated residential and occupational post
- application exposures using default DFR values for fluop yram are minimal in comparison to the level of concern (i.e., the calculated MOE is greater than 2 times higher than the level of concern, residential MOE = 2,100 and occupational MOE = 250 compared to the LOC of 100); EPA is not imposing the 40 CFR §158 DFR data requirement at this time . In this instance, it is unlikely that chemical
- specific DFR data would be needed to further refine exposure assessments or would add appreciably to our overall understanding of the availability of dislodgeable foliar pesticide residues for fluopy ram. Turf Transferrable Residues A turf transferrable residue study has not been submitted for fluopy ram. Therefore, HED’s standard operating procedures and assumptions were used to determine an estimate of day zero fluopy ram residues on treated turf. In accordance with 40 CFR §158, TTR data are required for all occupational (e.g., sod farms, golf courses, parks, and recreational areas) or residential turf uses that could result in post
application exposure to turf. In the absence of chemical
- specific TTR data, EPA uses default values. The 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment includes an analysis of all TTR data, available at the time, which resulted in the selection of revised liquid and granular default values for the fraction of the application rate available for transfer after a turf application (F AR

### ). These values are based on an anal ys is of 59 TTR studies performed with the Modified California Roller Method (36 studies using liquids, 11 studies using wettable powders/water dispersible granules, and 12 studies using granules). The l iquid results (N=131) indicate a range of F AR 

### values from 0.0005% to 6.1% and the granular results (N=37) indicate a range of 0.00064% to 0.69%. In both the liquid and granular data, a large range of transferability is observed and this variability can po tentially

be attributable to many factors such as active ingredient; formulation; field conditions in the studies; weather

### Fluopy

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Page **56** of **87** conditions (e.g., humidity); or many other difficult to quantify factors. Although witnessed across multiple chemicals, this range in F AR 

### values is not expected when considering TTR data for a single chemical. HED selected 1% and 0.2% as high
- end default values for liquid and granular products, respectively . Because TTR data are not available for fluopy ram, EPA is using the default v alue of 1%. Although there may be a small degree of uncertainty in the use of the default TTR value for fluopy ram (i.e., there is a small chance that the F AR 

### value may exceed the applicable default value ), it is likely that the health
-protective aspects o f EPA’s residential and occupational post
- application turf assessment methodology will more than compensate for this potential uncertainty (i.e., the methodology is likely to overestimate exposure b y a factor greater than the factor than the highest measured F AR 

### values exceed the defaults ). For example, when assessing residential post
- application turf exposure, EPA assumes the following: exposures occur to zero - day

(i.e., day of application ) residues every day of the assessed exposure duration (i.e., EPA assumes that no dissipation or degradation occurs, it doesn’t rain, the grass is not mowed, etc.); individuals perform the same post
- application activities performed in the turf transfer coefficient study day after day (e.g., tumbling, playing on turf with toys, etc.); and individuals engage in these post
- application activities for a high
- end amount of time every day that is represented b y data reflecting time children spend outdoors and not specificall y engaged in activities on turf, when in actuality chi ldren do not spend all of their outdoor time on turf and high
- end levels of activity will not occur every

day
. Given the conservatisms discussed above and the potential compounding nature of these conservatisms, EPA is able to rely upon the calculated exp osure estimates with confidence that exposure is not being underestimated. Since the estimated residential turf post
- application exposure from high contact activities on lawns and the occupational post
- application activities on golf course turf using defa ult TTR values for fluop yr am are minimal in comparison to the level of concern (i.e., the calculated MOEs are greater than 10 times higher than the level of concern, residential MOE = 1,000 and occupational MOE = 9,000, compared to the LOC of 100); EPA is not imposing the 40 CFR §158 TTR data requirement at this time . In this instance, it is unlikely that chemical
- specific TTR data would be needed to further refine exposure assessments or would add appreciabl y to our general understanding of the availability of turf transferable pesticide residues. **Restricted Entry Interval :**  Since post
- application risks were not a concern on day 0 (12 hours following application), the REIis based on the acute toxicity of fluop yr am technical material. Fluopy ram is classified as T oxicity C ategory I II by the acute oral and dermal route s of exposure and Toxicity

Category IV for acute inhalation, eye irritation potential and skin irritation potential. Under the WPS for Agricultural Pesticides, active ingredients cl assified as acute toxicity categories III or IV for these routes are assigned a 12
- hour REI. Therefore, the 12
- hour REIthat appears on the proposed label s is adequate. **9.2.2 Inhalation**  **Post -**  **application Risk**  There are multiple potential sources of post
- application inhalation exposure to individuals performing post
- application activities in previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain

### Fluopy

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Page **57** of **87** pesticides. The agency

sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 (http ://www.epa.gov/scipoly /SAP/meetings/2009/120109meeting.html ). The agency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis (http://www.regulations.gov/#!docketDetail;D=EPA
- HQ
OPP
- 2014
- 0219 ). During Registration Review, the agency will utilize this anal ys is to determine if data (i.e., flux studies, route
- specific inhalation toxicological studi es) or further anal ys is is required for fluop yr am ]
. In addition, the Agency

is continuing to evaluate the available post
- application inhalation exposure data generated by the Agricultural Reentry Task Force. Given these two efforts, the Agency will continue to identify

the need for and, subsequently , the way to incorporate occupational post
- application inhalation exposure into the agency's risk assessments. Although a quantitative occupational post
- application inhalation exposure assessment was not perfo rmed, an inhalation exposure assessment was performed for occupational/commercial handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than post
- application exposure. Therefore, it is expected that these handler inhalation exposure estimates would be protective of most occupational post
- application inhalation exposure scenarios.”

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Page **58** of **87 10.0**  **References** O’ Keefe, B., 12/18 /201 5 , D 4 26622

. Fluop yram : Occupational and Residential Expo sure Assessment for New Uses on artichoke (globe), Brassica (cole) leafy vegetables, Brassica (cole) leafy vegetables head and stem subgroup, bulb vegetables, canola, carrot, cereal grains (except rice), citrus, corn (including field, sweet, popcorn, and field corn grown for seed) cotton, cucurbit vegetables, fruiting vegetables, ginseng, grapes and small vines fruits (except fuzzy kiwifruit), herbs and spices (except black pepper), hops, leafy vegetables, legume vegetables (including soy bean), peanut, pome fruits, potato and other root, tuberous and corm vegetables, small berries (caneberries and bushberries), stone fruit, strawberry and other low growing berries, sugar beet, sunflower subgroup, tree nuts ; use as a seed treatment to peanuts ; turf grass (g ol f c ourses, s od f arms, sports f

ields, r esidential, industrial, municipal, c ommercial, and other turf grass areas ), ornamentals ( in r esidential and c ommercial settings), and Christmas trees
. Cheng, L., 0 9 /23 /2011, D387587 and D 389081. Fluopy ram. Application for Section 3 Registration for Use on Apple, Banana (Import only), Dried Beans, Cherry , Grape (Wine Production only), Peanut, Pistachio, Potato, Sugar Beet, Strawberry , Tree Nuts Crop Group 14, Watermelon, and Rotational Crops Alfalfa, Canola, Cotton, Cereal Grains Crop (Except Rice) Group 15, and Forage, Fodder, and Straw of Cereal Grains Crop (Except Rice) Group 16. Summary of Anal ytical Chemistry

and Residue Data. Negussie, M., 11/10/2015 , D426 6 20. Fluop yram. Tolerances and Registration for Use on Crop Subgroup 1B, Subgroup 1C, Crop Group 2, Subgroup 3
- 07A, Subgroup 3
- 07B, Subgroup 4 A, Subgroup 4 B , Subgroup 5A, Subgroup 5B, Subgroup 6A, Subgroup 6B, Dry B ean , Subgroup 8
- 10A, Subgroup 8
- 10B, Subgroup 9A, Subgroup 9B, Subgroup 10
- 10, Group 11
- 10, Subgroup 12
- 12A, Subgroup 12
- 12B, Subgroup 12
- 12C, Subgroup 13
- 07 A, Subgroup 13
- 07B, Subgroup 13
- 07F, Subgroup 13
- 07G, Crop Group 15 (except corn and rice), C rop Group 16, Sub group 19A, Dill Seed , Subgroup 20A , Subgroup 20B, Subgroup 20C, Artichoke (Globe), Hops, Soy bean, and Sugarcane (Rotated). Amended Tolerance Requests for the Registered Uses due to Crop Group/Subgroup Expansion Requests, Additional Use Patterns, and Tolerance Re
Assessments. Summary

of Anal ytical Chemistry

and Residue Data. Negussie, M., 11/10/2015 , D 426621
. Fluop yram: Acute and Chronic Aggregate Dietary Exposure and Risk Assessments for Section 3 Registration for New Uses on Crop Subgroup 1B, Subgroup 1C, Crop Group 2, Subgroup 3
- 07A, Subgroup 3
- 07B, Subgroup 4 A, Subgroup 4 B , Subgroup 5A, Subgroup 5B, Subgroup 6A, Subgroup 6B, Dry Bean , Subgroup 8
- 10A, Subgroup 8
- 10B, Subgroup 9A, Subgroup 9B, Subgroup 10
- 10, Group 11
- 10, S ubgroup 12
- 12A, Subgroup 12
- 12B, Subgroup 12
- 12C, Subgroup 13
- 07 A, Subgroup 13
- 07B, Subgroup 13
- 07F, Subgroup 13
- 07G, Crop Group 15 (except corn and rice), Crop Group 16, Subgroup 19A, Dill Seed , Subgroup 20A, Subgroup 20B, Subgroup 20C, Artichoke (Globe) , Hops, Soy bean, and Sugarcane (Rotated). Amended Tolerance Requests for the Registered Uses due to Crop Group/Subgroup Expansion Requests, Additional Use Patterns, and Tolerance Re
- Assessments. Summary of Anal ytical Chemistry

and Residue Data.

### Fluopy

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Page **59** of **87** Ruhman, M. A., 10/26/20 15: Refinement of the Estimated Drinking Water Concentrations of Fluopy ram New Uses on Artichoke, Vegetables (Brassica, bulb, cucurbits, fruiting, leafy , legumes and root/tuberous/corm), Carrot, Cereal grains, Citrus, Cotton, Ginseng, Grapes , Small vines fruits, grasses (forage/feed/seed), Herbs, Hops, Soy bean, Oil seed group, Ornamentals, Peanut, Pome fruits, Potato, Small berries, Stone fruit, Strawberry and other low
- growing berries, Sugarbeet, Tree nuts and Turf for Use in Human Health Ri sk Assessment. Ruhman, M. A., 04/01/20 15: Estimated Drinking Water Concentrations of Fluopy ram New Uses on Artichoke, Vegetables (Brassica, bulb, cucurbits, fruiting, leafy , legumes and root/tuberous/corm), Carrot, Cereal grains, Citrus, Cotton, Ginseng, Grapes, Small vines fruits, grasses (forage/feed/seed), Herbs, Hops, So ybean, Oil seed group, Ornamentals, Peanut, Pome fruits, Potato, Small berries, Stone fruit, Strawberry and other low
- growing berries, Sugarbeet, Tree nuts and Turf for Use in Human Health Risk Assessment. Scollon, E., 7/16/2009, D367115. Fluopy ram. Report of the Residues of Concern Knowledgebase Subcommittee (ROCKS). Rowland, J., 05 /08 /20 14 , TXR0056961
. Fluopy ram : Report of the Cancer Assessment Review Committee
. Rury , K., 01/30/2013, TXR 0056523
. Fluopy ram : Summary

of Hazard and Science Policy Council (HASPOC) Meeting of November 29, 2012: Recommendations on the Waiver Request for the Subchronic Inhalation Study Data Requirement.

### Fluopy

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Page **60** of **87 A** **ppendix A**  **. Toxicology Profile**  **A.1 T**  **oxicology Data Requirements** The requirements (40 CFR 158.500 ) for food use for fluopy ram are in Table A. 1. Use of the new guideline numbers does not imply that the new (1998) guideline protocols were used. **Table A.1. Toxicology Data Requirements. Study**  **Technical Required**  **Satisfied** 870.1100 Acute Oral Toxicity
................................ ....................... 870.1200 Acute Dermal Toxicity
................................ .................. 870.1300 Acute Inhalation Toxicity
................................ .............. 870.2400 Primary Eye Irritation
................................ .................... 870.2500 Primary Dermal Irritation
................................ .............. 870.2600 Dermal Sensitization
................................ ...................... yes yes yes yes yes yes yes

yes yes yes yes yes 870.3100 Oral Subchronic (rodent)
................................ ............... 870.3150 Oral Subchronic (nonrodent)
................................ ......... 870.3200 21
- Day

Dermal
................................ .............................. 870.3250 90
- Day

Dermal
................................ .............................. 870.3465 90
- Day

Inhalation
................................ .......................... yes yes yes no yes yes

yes yes

- Waived a 870.3700a Developmental Toxicity (rodent)
................................ ... 870.3700b Developmental Toxicity (nonrodent)
............................. 870.3800 Reproduction
................................ ................................ . yes yes yes yes

yes yes 870.4100a Chronic Toxicity (rodent)
................................ .............. 870.4100b Chronic Toxicity (nonrodent)
................................ ........ 870.4200a Oncogenicity (rat)
................................ .......................... 870.4200b Oncogenicity (mouse)
................................ .................... 870.4300 Chronic/Oncogenicity
................................ .................... - yes

- yes yes -

yes

- yes yes 870.5100 Mutagenicity

—Gene Mutation
- bacterial
..................... 870.5300 Mutagenicity

—Gene Mutation
- mammalian
................ 870.5xxx Mutagenicity

— Structural Chromosomal Aberrations
... 870.5xxx Mutagenicity

—Other Genotoxic Effects
....................... yes yes yes yes yes

yes yes yes 870.6100a Acute Delayed Neurotoxicity (hen)
............................... 870.6100b 90
- Day

Neurotoxicity (hen)
................................ ........... 870.6200a Acute Neurotoxicity Screening Battery (rat)
................. 870.6200b 90
- Day

Neurotoxicity Screening Battery (rat)
............... 870.6300 Develop. Neurotoxicity
................................ ................. no no yes yes no -

- yes yes

- 870.7485 General Metabolism
................................ ...................... 870.7600 Dermal Penetration
................................ ........................ 870.7800 Immunotoxicity
................................ ............................. yes yes yes yes

yes yes a : (HASPOC, 1/30/2013; TXR 0056523) :

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Page **61** of **87 A.2**  **Toxicity Profile s**  **Table A.2.1 Acute Toxicity Profile**  **for Fluopyram**  **. Guideline**  **No. Study Type**  **MRID Results**  **Toxicity Category**  870.1100 Ac ute oral
- rat 47372430 No mortalities observed at 2000 mg/kg III 870.1200 Ac ute dermal
- rat 47372432 LD 50 > 2000 mg/kg III 870.1300 Ac ute inhalation
- rat 47372435 47372434 LC 50 at 4 hours > 5112 mg/m 3

LC 50 > 5.1 mg/L IV
870.2400 Ac ute eye irritation
- rabbit 47723701 Non
- irritating IV 870.2500 Ac ute dermal irritation
- rabbit 47372436 Non
- irritating IV 870.2600 Skin sensitization
- mo use 47372440 Non
- sensitizing Not Applicable


### Table A.2.2 **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** Non
- guideline 28
- day dietary rat

study (exploratory) 47372516; (2004)

Acceptable 50, 400, 3200 ppm (4., 31, & 254 mg/kg/day ♂ 4.6, 36, & 263 mg/kg/day ♀) NOAEL = 31 mg/kg/day LOAEL = 254 mg/kg/day based on  platelet count and prothrombin time (M),  cholesterol and triglycerides (M/F),  aspartate aminotransferase and alkaline phosphatase  liver weight with hepatocellular hypertrophy (M/F)  thyroid weight with follicular cell hypertrophy (M) Non
- guideline 28
- day rat study

(dietary) (preliminary) AE C657188 (PCA), a soil metabolite of AE C638206 47372521; (2003)

Acceptable 20; 200; 2,000, & 20,000 ppm (1.5; 15; 149; & 1,574 mg/kg/day for ♂ 1.6; 16; 162; & 1,581 mg/kg/day for ♀) NOAEL=1574 mg/kg (HDT) no compound related effects were seen.

870.3100 90
- day dietary rat

study 47372441; (2005)

Acceptable/guideline 0, 50, 200, 1000, 3200 ppm ♂: 3, 13, 61, & 204 mg/kg/day ♀: 4, 15, 70, & 230 mg/kg/day NOAEL = 13 mg/kg/day LOAEL = 61 mg/kg/day based on ↓ body weight & food consumption, hematology parameters affected. ↑ cholesterol conc & 
- glutamyltransferase activity. Slight ↑ in TSH, T3 & T4. ↑ liver, thyroid gland & kidney weights. Liver: centrilobular hypertrophy & periportal to midzonal hepatocellular macrovacuolation. Thyroid gland: follicular cell hypertrophy.

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Page **62** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** Non
- guideline 28
- day dietary study

in the mouse (preliminary) 47372517; (2004)

Acceptable 150; 1,000; 5,000 ppm ♂: 25, 162, & 747 mg/kg/day ♀: 31, 162, & 954 mg/kg/day NOAEL = 25 mg/kg/day LOAEL = 162 mg/kg/day based on ↓ body weight gain (M), ↑ ALT (M), ↑ liver weights, 27
- 49% (M/F) associated with: centrilobular hypertrophy, single cell and focal necrosis, hepatocellular eosinophilia and bile duct/oval cell hyperplasia (M/F). Adrenal gland: hypertrophy of zona fasciculata (F). 870.3100 90
- day dietary study

in the mouse 47372442; (2005)

Acceptable/guideline 30, 150, 1000 ppm ♂ : 5, 27, & 188 mg/kg/day ; ♀: 7, 32, & 216 mg/kg/day NOAEL = 27 mg/kg/day LOAEL = 188 mg/kg/day based on ↑ ALT & ↓ albumin conc. (M/F), ↓ cholesterol conc & ↑ alkaline phosphatase (M), ↑ liver weights, 34
- 45% (M/F), ↑ adrenal gland weights, 87
- 92% (M) Liver: centrilobular hypertrophy and focal necrosis (M/F) Adrenal gl and: ↓ ceroid pigment (M), ↑ cortical vacuolation (F). Non
- guideline 28
- day oral toxicity

study in dogs (gavage) 47372515; (2004)

Acceptable 30, 150, & 750 mg/kg/day NOAEL = 150 mg/kg/day LOAEL = 750 mg/kg/day based on ↓ erythrocyte count, hemoglobin, hematocrit (M), ↑ alkaline phosphatase (M/F), ↓ albumin conc. (M/F), ↑ 
- glutamyltransferase activity and triglyceride concentration (F). ↑ liver weights associated with hepatocellular hypertrophy (M/F). 870.3150 90
- day dietary

toxicity study in the dog 47372443; (2006 )

Acceptable/guideline 800; 5,000, & 20,000/10,000 ppm (at day 15, the high dose group dietary concentration was reduced due to lack of palatability) ♂: 29, 171, & 332 mg/kg/day ♀: 33, 184, & 337 mg/kg/day NOAEL = 29 mg/kg/day LOAEL = 171 mg/kg/day based on liver effects characterized by ↑ alkaline phosphatase , 
- glutamyltransferase activity, ALT & AST; ↓ albumin conc and bilirubin; ↑ liver weights associated with hepatocellular hypertrophy, intracytoplasmic eosinophilic droplet s and single cell necrosis. Both sexes were affected.

870.3200 28
- day dermal

toxicity study in the rat 47372444; (2007)

Acceptable/guideline 100; 300; & 1,000 mg/kg/day NOAEL = 300 m/kg/day LOAEL = 1,000 mg/kg/day based on ↑ cholesterol (F), ↑ prothrombin time (M)
. 870.3700 Developmental

toxicity in the rat 47372445; (2008, Report)

(Study conducted in 2006) Acceptable/guideline Maternal NOAEL = 30 mg/kg/day Maternal LOAEL = 150 mg/kg/day based on decreased body weight gains and food consumption, higher liver weights and diffused centrilobular hepatocellular hypertrophy. Developmental NOAEL= 150 mg/kg/day Developmental LOAEL = 450 mg/kg/day based Decreased fetal body weight (5%), increased incidence of two minor variations at both the visceral and skeletal evaluation.

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Page **63** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** 870.3700 Developmental

toxicity study in the rabbit 47372446; (2006)

Acceptable/guideline 10, 25, & 75 mg/kg bw/day (gavage, GD 6
- 28) Maternal NOAEL = 25 mg/kg/day Maternal LOAEL = 75 mg/kg/day based on reduced body weight gain and food consumption. Developmental NOAEL = 25 mg/kg/day Developmental LOAEL = 75 mg/kg/day based on d ecreased fetal body weight (
- 11%). Non
- guideline Dose range - finding

reproduction study in the rat 47372448; (2008) (Report)

Acceptable 30; 150; 750; & 1,500 ppm ♂: 2,10, 50, & 102 mg/kg/day ♀: 2, 12, 58, & 118 mg/kg/day. Parental NOAEL = 10 mg/kg/day Parental LOAEL = 50 mg/kg/day b ased on increased liver and kidney weights Offspring NOAEL = 118 mg/kg/day (HDT) Reproductive NOAEL = 118 mg/kg/day (HDT) No effect was seen in any of reproductive parameters examined. 870.3800 2
- Generation

reproduction study in the rat 47372447; (2008, Report)

Acceptable/guideline 40; 220; & 1, 200 ppm ♂: 3, 15, 83 mg/kg/day (premating) ♀: 3, 18, & 96 mg/kg/day (premating). Parental NOAEL = 15 mg/kg/day Parental LOAEL = 83 mg/kg/day based on increased creatinine, total protein, and albumin , and increase d kidney weight. Offspring NOAEL = 15 mg/kg/day Offspring LOAEL= 83 mg/kg/day based on d ecreased body weight (8%) with decreases in spleen and thymus weights
. Reproductive NOAEL = 96 mg/kg/day (HDT). No effect was seen in any of reproductive parameters e xamined. 870.4100 1
- ye ar toxicity study

in dogs (dietary) 47372449; (2007)

Acceptable/guideline 100; 400; & 2,000 ppm ♂: 3, 13, & 68 mg/kg/day ♀: 4, 14, & 66 mg/kg/day. NOAEL = 13 mg/kg/day LOAEL = 66 mg/kg/day based on ↓ body weight & food consumption (M/F), ↑ alkaline phosphatase (M/F), Liver: centrilobular hypertrophy.

870.4200 Carcinogenicity

study in the mouse 47372450; (2007)

Acceptable/guideline 30, 150, & 750 ppm ♂: 4, 21, & 105 mg/kg/day ♀: 5, 27, & 129 mg/kg/day. NOAEL = 4 mg/kg/day LOAEL = 21 mg/kg/day b a sed on follicular cell hyperplasia in the thyroid gland, centrilobular to panlobular hypertrophy and hepatocellular single cell degeneration /necrosis in the liver. Thyroid gland follicular cell adenomas in high dose males.

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Page **64** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** 870.4300 Chronic

/carcino genicity study in the rat 47372501; (2008)

Acceptable/guideline 30 , 150 & 750/375 ppm for ♂; 30 , 150 and 1,500 ppm for ♀. ♂: 1.2, 6.0, & 29 mg/kg/day ♀: 1.7, 8.6, & 89 mg/kg/day (Due to high mortality in 750 ppm males, this concentration was reduced to 375 ppm from week 85 onward) NOAEL = 1.2 mg/kg/day LOAEL = 6.0 mg/kg/day based on liver toxicity, nephropathy, and follicular cell hypertrophy in the thyroid gland. Liver cell tumors (carcinoma and adenoma) in high dose females.

870.5100 Ames test 47372502; (2006) Acceptable/guideline Doses: 16 to 5000 μg/plate +/
- metabolic activation Negative

870.5100 Ames test 47372503; (2008) Acceptable/guideline Doses: 5 to 1581 μg/plate 16 to 5000 μg/plate +/
- metabolic activation Negative

870.5300 In

- vitro

chromosome aberration (V79 cells). 47372505; (2005)

Acceptable/guideline Concentrations: 30, 60, 120, 180, & 240 μg/ml. Negative

870.5300 HPRT Test (V79

cells). 47372504; (2006)

Acceptable/guideline Concentrations: 4 to 256 μg/ml +/
- metabolic activation. Negative

870.5385 In

- vivo micro
nucleus test in male mice 47372506; (2005)

Acceptable/guideline Doses: 250, 500, & 1000 mg/kg. Negative

870.6200a Acute neurotoxicity

screening battery 47372507; (2007)

Acceptable/guideline Initial study 125; 500; and 2,000 mg/kg/day NOAEL = 125 for males ; <125 for females Based on ↓ motor and locomotor activity, clinical signs and ↓ body temperature LOAEL for male = 500 mg/kg/day based on ↓ motor and locomotor activity. Follow
- up study using only female rats 25, 50 and 100 mg/kg/day. NOAEL = 50 mg/kg/day LOAEL = 100 mg/kg/day based on ↓ motor and locomotor activity.

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Page **65** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** 870.6200b Subchronic

neurotoxicity screening battery 47372508; (2008, Report)

(The study was conducted in 2007) Acceptable/guideline 100; 500; & 2,500 ppm ♂: 7, 33, & 164 mg/kg/day ♀: 8, 41, & 197 mg/kg/day NOAEL = 33 mg/kg/day LOAEL = 164 m/kg/day based on a host of effects which included incre ases in cholesterol and triglyceride levels, decrease in glucose level, decreases in hemoglobin and hematocrit, and deceases in body weight and food consumption
. No evidence of neurotoxicity in either neurobehavioral parameter or histopathology. 870.7485 ADME study in rats 47372509; (2008) Acceptable/guideline 5 & 250 mg/kg (single dose by gavage )( 14 C on phenyl ring) 5 mg/kg (radiola

beled fluopyram) after 14 days pre
treatment With oral dosing, fluopyram was rapidly absorbed (93.2 % of administered radioactivity) from the GI tract of male and female rats. The max. plasma concentration was reached at 15 hrs in males and 11 hrs in females post dosing with 5 mg/kg. After 168 hrs post dosing 91
- 99 % of the administered radioactivity was eliminated via urine (32
- 41% of the administered dose) and feces (53
- 65% of the administered dose) . The ratio of renal and fecal elimination was comparable (45% via urine and 47% via feces). The organ which contained the highest radioactivity was the liver (0.4 to 1.0 % of the administered radioactivity. ) Considerable enterohepatic circulation was demonstrated by the results. Fluopyram was extensively metabolized and 29 metabolites were identified. It was proposed that three main metabolite groups were formed in the liver ( fluopyram
- 7
- OH
- GA, 8
- OH
- GA and enol
- GA) (GA=glucuronic acid). 870.7485 ADME in the rat 47372511; (2008) Acceptable/guideline Single oral dose, 5 mg/kg (gavage) ( 14 C in position s 2 & 6 of the pyridyl ring) With oral dosing, fluopyram was absorbed rapidly and efficiently eliminated from the body (>98% of the administered radioactivity was eliminated) after 72 hrs post dosing. No significant residues remained in the body. Considerable enterohepatic circulation occurred. Three main metabolite groups were formed in the liver (fluopyram
- 7
- OH
- GA, 8
- OH
- GA and enol
- GA) (GA= glucuronic acid). 870.7485 Distribution of total

radioactivity in male & female rats 47372513; (2008)

Acceptable/non
- guideline Single dose 14 C in the phenyl ring of fluopyram at 3 mg/kg. Distribution occurred in almost all organs with liver reaching the maximal concentration first, and most of the tissue reaching the peak concentration at approximately 24 hr post
- dosing. By 136 hr post dosing little of the radioactivity was present in most organs except nasal mucosa. 870.7485 Distribution of 14 C

labeled fluopyram. 47372512; (2008)

Acceptable/non
- guideline 3 mg/kg for ♂ & 4.5 mg/kg for ♀ (Single oral dose; 14 C on pyridyl ring of f luopyram. ) Fluopyram was readily absorbed from the GI tract and distributed among almost all organs. P eak level was reached at approximately 1 hr after dosing in most organs with liver having the higher concentration than other organs. From peak level s, a continuous but slow decline of radioactivity concentrations was observed for all organs. 870.7485 Metabolism in

organs and tissues in rats 47372509 ; (2008)

Acceptable/non
- guideline 5 mg/kg (Single oral dose; 14 C in the 2 & 6 p osition of the pyridyl ring of fluopyram). AE C656948 was extensively metabolized, and more than 20 metabolites were identified. The major metabolic transformation was oxidation and took place mainly at the ethylene bridge of the molecule. The major metabolites were AE C656948
- 7
-hydroxy and AE C656948
-pyridyl
- acetic acid.

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Page **66** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** 870.7600 In

- vitro dermal

absorption study with human and rat skin 47372514 (2007)

Acceptable 500 mg AE C656948 & 0.5 mg AE C656948 (spray dilution) Dermatomed skin membranes from human and rat were examined. The report stated that over a period of 24 hrs the potentially absorbable [ 14 C]

– AE C656948 was 1.8% and 12.4 % for human and rat skin, respectively. This results in approximately 6x difference between dermatomed human and rat skin. Rat skin being more permeable. In

- vivo dermal absorption 47567201 (2008)

Acceptable/guideline 0, 60 μg (spray dilution) and 60 mg (neat) The maximal dermal absorption rates for neat formulation and spray dilution we re 4.5% and 12.8% of the applied dose, respectively
. 870.7800 28
- Day

immunotoxicity study in rats 48239930; (2010)

Acceptable/guideline 0, 200, 600, 1800 ppm 0, 17.2, 53.6, 156.3 mg/kg/day. Immunotoxicity NOAEL for anti
- SRBC IgM response = 156.3 mg/kg/day (HDT).
**Mechanistic Studies** Non
- guideline 7
- Day mechanistic

study in female rats (dietary administration) 47372520; (2008)

Acceptable/non
- guideline 3,000 ppm (193 mg/kg/day). Feeding fluopyram at 193 mg/kg/day in the diet to female rats did not affect body weight, clinical signs or food or water consumption. Mean absolute and relative liver weights were increased (40 to 43%) relative to the controls. This increase was associated with enlarged and dark livers in 13/15 females. At histological examination, minimal to slight centrilobular to panlobular hepatocel lular hypertrophy was found in all treated animals. There was a 4x increase in mean BrdU labeling index in both the perilobular and centrilobular areas of the hepatic lobule in treated animals relative to the controls. A slight increase in total P
- 450 co ntent and in mean EROD activity, a moderate increase in mean PROD and BROD activities and a marked increase in mean UDPGT activity (all statistically different from the control group (p ≤0.01)) were seen. The report concluded that AE C656948 has the ability to induce moderately phenobarbital
- inducible hepatic enzymes (total cytochrome P
- 450, BROD and PROD and UDPGT) as well as liver hypertrophy and cell proliferation in the liver.

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Page **67** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** Non
- guideline 7
- Day mechanistic

study with Phenobarbital Reduction in activity in all treated animals & slight reduction in body weight gain. Mean absolute and relative liver weights were increased ( ≈ 22%) relative to the controls. Dark liver was found in 5/14 females and enlarged liver in 3/14 females. Minimal to slight centrilobular to panlobular hepatocellular hypertrophy was found in all treated animals. A 2x increase in mean BrdU labeling index in the perilobular and centrilobular areas in the treated animals. A moderate increase in total P
- 450 content and in mean PROD, BROD and UDPGT activities (all statistically different from the control group p ≤0.01). The report states that phenobarbital has the ability to induce hepatic enzymes like total cytochrome P
- 450, PROD, BROD and UDPGT activities as well as liv er hypertrophy and cell proliferation in the liver. Non
- guideline 14
- Day dietary

administration to the mice (hepatotoxicity and thyroid hormone investigations) 47372519; (2008

Acceptable/non
- guideline 2,000 ppm 308 and 314 mg/kg for 3 or 14 days, respectively. After 3 days of exposure, mean T3 level was not changed, whereas mean T4 level was decreased (
- 30%) while mean TSH level was increased (+18%) relative to the controls. Mean absolute and relative liver weights were increased by approximately 60%. Enlarged liver was found in all the treated animals. Diffuse centrilobular to panlobular hepatocellular hypertrophy and an increased number of mitoses were observed in all examined treated animals. In addition, hepatocellular single cell necrosis was observed in 1/5 treated animals. No significant microscopic change was observed in the thyroid gland. Total cytochrome P
- 450 content was markedly increased (+116%) by the treatment. EROD activities were marginally increased (+235%), whereas PROD and BROD activities were markedly increased (respectively +2890% and +8717%) relative to controls. No significant changes were observed in UDPGT. Non
- guideline Phenobarbital 14
-

day mechanistic study in the mouse (gavage) (hepato
toxicity and thyroid hormone investigations) 47372522; (2008)

Acceptable/non
- guideline 80 mg/kg for 3 or 14 days by gavage. The report stated that phenobarbital administration at a dose level of 80 mg/kg body weight/day in the mouse for 3 and 14 days induced significant liver changes including increases in hepatic total cytochrome P
- 450, PROD and BROD activities. Phenobarbital also induced a modification of the normal thyroid hormone balance (in particular by a decrease in T4 and/or T3 after 3 and/or 14 days of exposure together with a concomitant increase in TSH level after 14 days. ) Non
- guideline In
- vitro studies on

the potential interactions with thyroid peroxid a se catalyzed reactions 47372518; (2008)

Acceptable/non
- guideline 300 μM Fluopyram at 300 μM did not affect thyroid peroxidase ( TP O)
- catalyzed guaiacol oxidation and TP O
- catalyzed iodine formation. Therefore, the data show that fluopyram does not affect thyroid hormone synthesis at the level of TPO. Non
- guideline Mechanistic 3
- Day

toxicity study in the mouse by gavage (thyroid hormone investigations) 49005901 (2012)

Acceptable/non
- guideline 0, 100 or 300 mg/kg bw/day for 3 days
. There were no compound related effects on mortality or clinical signs. Plasma T4 levels were significantly decreased in treated animals at all time
- points with no obvious time
- related trends, Plasma TSH levels were comparable to controls.

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Page **68** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** Non
- guideline Mechanistic

Investigations in the Liver of Female Rats Following Dietary Administration for 28 days 49005902 (2012)

Acceptable/non
- guideline 0, 30, 75, 150, 600 or 1500 ppm (0, 2.2, 5.6, 11.3, 44.5, or 111.4 mg/kg bw/day) for 28 days. A one month recovery period in control and high dose animals assessed reversibility of effects. Phenobarbital was used as a positive control at 80 mg/kg bw/day. Ab solute and relative liver weights were increased at ≥ 44.5 mg/kg bw/day fluopyram and in the phenobarbital
- treated group. Following the recovery phase, liver weights were nearly identical among control, high dose fluopyram
- and phenobarbital
treated rats. Visibly enlarged livers were seen starting at 5.6 mg/kg bw/day with red foci and prominent lobulation being recorded at higher dose levels. Hepatocellular hypertrophy was observed starting at 44.5 mg/kg bw/day. After 28 days of treatment, mean liver cell proliferation was increased in the fluopyram treated groups starting at 5.6 mg/kg bw/day and in the phenobarbital group. Enzyme activity was increased in fluopyram
- and phenobarbital
- treated rats. These activity levels showed partial reversibility following recovery. Gene transcript expression was increased for both fluopyram
- and phenobarbital
- treated rats, though there were notable differences in expression between compounds. Partial reversibility was evident after a month without treatment. Non
- guideline 28
- Day Toxicity

Study for Proliferation Assessment in the male Mouse 49005904 (2012)

Acceptable/non
- guideline 0 or 750 ppm (0 or 127 mg/kg bw/day) for 28 days Phenobarbital (gavage) as positive control Enlarged and dark livers were present in treated mice. Phenobarbital
- treated mice also exhibited dark thyroids without microscopic correlates. The BrdU labeling index was increased in the fluopyram group, but not the phenobarbital group. Non
- guideline 28
- Day Toxicity

Study for Thyroid Cell Proliferation in the Mouse 49005905 (2013)

Acceptable/non
- guideline 0, 30, 75, 150, 600, 750 or 1500 ppm (0, 5, 13, 25, 99, 124 or 247 mg/kg bw/day) for 28 days. (28
- day recovery groups consisted of control and high dose animals) There were no compound related effects on mortality, clinical signs, body weight, food or water consumption, organ weights, or gross and histologic pathology. The proliferation index in the thyroid was increased starting at 25 mg/kg bw/day.

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Page **69** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** Non
- guideline 28
- Day Dietary

Study to Determine Potential Role of the Nuclear Pregnane X Receptor (P XR) and Constitutive Androstane Receptor ( C AR) on the Thyroid Changes Following the Administration of Fluopyram to Male Mice (C57BL/6J and P XR KO/C AR KO). 49005906 (2013)

Acceptable/non
- guideline 0, 750 or 1500 ppm (125 or 256 mg/kg bw/day for wild type and 130 or 247 mg/kg bw/day for knockout) for 28 days. There were no effects on mortality, clinical signs, body weight or food or water consumption. Liver weights were increased in all fluopyram- treated mice. Enlarged livers were observed in the wild type groups, but not in controls or knockout groups. In treated wild type mice, there was an increase in hepatocellular hypertrophy. There were no similar treatment
- related effects in the knockout mice. Thyroid cell proliferation was increased in wild type mice, while the knockout mice had a slight decrease in proliferation index that was likely incidental. Total cytochrome P
- 450 content was increased in treated wild type mice, but not in treated k nockout mice. PROD activity was greatly increased in treated wild type mice and slightly increased in treated knockout mice. BQ activity was increased in wild type mice while the knockout mice showed slight decreases. Thyroxine glucuronosyl transferase (T4
- GT) and bilirubin glucuronidation (BIL
- GT) activities were increased in treated wild type mice, but showed no change in treated knockout mice except for a slight decrease in T4
- GT activity at 247 mg/kg bw/day. There was a significant increase of Tsh beta transcript in the pituitary gland of treated wild type mice and a slight decrease in the same measure for high dose knockout mice. Non
- guideline Enzyme and DNA
Synthesis Induction in Cultured Human Hepatocytes, Main Study 49005907 (2013)

Acceptable/non
- guideline 0, 1, 3, 10, 30, 100 or 300 μM fluopyram or at 10, 100 or 1000 μM phenobarbital for 96 hours. Epidermal growth factor, at 25 ng/mL, was used as a positive control ATP concentration in the fluopyram groups indicated that cytotoxicity

begins around 100 μM fluopyram. Phenobarbital did not affect ATP levels. There was no effect on DNA synthesis with either fluopyram or phenobarbital. The positive control substance generated a large increase in DNA synthesis. There was no dose
- related increase in PROD activity with fluopyram treatment, though all dose levels up to cy totoxic levels showed an approximate 2
- fold increase over controls. The same general effect was seen with phenobarbital. There was a dose
- dependent increase in BROD activity following fluopyram treatment. Phenobarbital treatment also produced an increase at the high dose. There was a slight increase in BQ activity at low dose levels of fluopyram. Phenobarbital caused a dose
- related increase at the mid and high dose level.

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- guideline Enzyme and DNA
Synthesis Induction in Cultured Rat Hepatocytes, Main Study 49005908 (2013)

Acceptable/non
- guideline 0, 1, 3, 10, 30, 100 or 300 μM fluopyram or at 10, 100 or 1000 μM phenobarbital for 96 hours. The test vehicle was DMSO. Epidermal growth factor, at 25 ng/mL, was used as a positive contro l. ATP concentration in the fluopyram groups was comparable to controls until cytotoxic levels. Phenobarbital did not appear to have an effect on ATP levels. DNA synthesis was increased with f luopyram and phenobarbital. Cytotoxicity at 100 and 300 μM fluopyram impacted the results. The positive control substance generated a large increase in DNA synthesis. There was an increase in PROD, BROD and BQ activity following fluopyram and phenobarbital treatment until cytotoxic levels. Non
- guideline Mechanistic 3
- Day

Toxicity Study in the Mouse by Oral Gavage (Thyroid Hormone Investigations) **49005909 (2011)**

Acceptable/non
- guideline 0, 100 or 300 mg/kg bw/day for 3 days. Phenobarbital was used as a positive control at 80 mg/kg bw/day. There were no compound related effects on mortality, clinical signs, body weight or gross pathology. There were small decreases in body weight gains in all treated groups, though this effect lacked a dose
- response relationship in the fluopyram groups. Plasma T4 levels were significantly decreased in all fluopyram
- and phenobarbital
- treated mice, but plasma TSH levels were comparable to controls. There was an increase in Tsh beta transcript in the pituitary in all treate d groups
.

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Page **71** of **87 Table A.2.2**  **Subchronic, Chronic and Other Toxicity Profile for Fluopyram.**  **Guideline No. Study Type**  **MRID No. (year)/ Classification/Doses**  **Results** Non
- guideline Mechanistic 28
- Day

Toxicity Study in the Mouse by Dietary Administration (Hepatotoxicity and Thyroid Hormone Investigations) 49005911 (2012) (28
- day

dietary study) 49005903 (2013) (PROD and BQ assessment) Acceptable/non
- guideline 0, 30, 75, 150, 600 or 750 ppm (0, 5, 13, 25, 102 or 128 mg/kg bw/day) for 28 days. Phenobarbital was used as a positive control at 80 mg/kg bw/day. There were no treatment
- related clinical signs or mortalities in the fluopyram groups. The phenobarbital group showed reduced motor activity during the dosing phase and there were three deaths between days 2 and 7. There were no treatment
- related clinical signs in any group during the recovery phase. There was no effect on body weight related to fluopyram treatment. Decreased body weight and body weight gain were noted in phenobarbital
- treated mice during treatment followed by increased body weight gains compared to controls during the recovery phase. There was no effect on food consumption in the fluopyram
- treated groups. The phenobarbital group had a small reduction in food consumption during the first week of dosing. Plasma T4 levels were decreased in fluopyram
- and phenobarbital
- treated animals while plasma TSH levels were comparable amongst all groups. Foll owing the recovery phase, plasma hormone levels were comparable across groups. Absolute and relative liver weights were increased in both fluopyram
- treated mice starting at 25 mg/kg bw/day and the phenobarbital
- treated mice following the dosing phase. After the recovery phase, all groups had comparable liver weights. UDPGT enzymatic activity towards bilirubin was increased in all treated animals and reached statistical significance at 102 and 128 mg/kg bw/day of fluopyram. Similar results were noted fo r UDPGT activity towards thyroxine, though the dose
- response relationship was not strong at the high dose. Following the recovery phase, the UDPGT activities were roughly comparable to controls. PROD and BQ activities were increased in fluopyram
- and pheno barbital
- treated mice at 28 days. The activities of both PROD and BQ were statistically comparable to controls following the recovery period. There was an increase of Tsh beta transcript in the pituitary gland of fluopyram
- and phenobarbital
- treated animals following the dosing phase. After the recovery phase, the fluopyram
- treated mice had slightly elevated relative tsh b, but the phenobarbital
- treated mice were similar to controls.

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Page **72** of **87 Appendix**  **B .**  **Physical/Chemical Properties Table**  **B 1.**  **Physicochem ical Properties of Fluopyram**  **.** Parameter Value Reference Melting point 118 oC MRID 47372240 pH 6.6 (1% aqueous solution; pure substance) MRID 47372236 Density 1.53 MRID 47372242 Water solubility (20 °C) Distilled water (pH 6.7) = 16 mg/L pH 4 = 15 mg/L pH 7 = 16 mg/L pH 9 = 15 mg/L MRID 47372247
Solvent solubility (g/L at 20 °C) heptane 0.66 toluene 62.2 dichloromethane >250 methanol >250 acetone >250 ethyl acetate >250 dimethyl sulfoxide >250 MRID 47372248

Vapor pressure 1.2 x 10 - 6 Pa at 20 oC 3.1 x 10 - 6 Pa at 25 oC 2.9 x 10 - 4 Pa at 50 oC MRID 47372249 Dissociation constant (pKa) 0.5 (23 oC) MRID 47372243 Octanol/water partition coefficient Log(KOW) 3.3 MRID 47372245 UV/visible absorption spectrum Peak max at 270 nm MRID 47372237

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Page **73** of **87 Appendix**  **C .**  **Review of Human Research** The PHED Task Force, 1995. The Pesticide Handlers Exposure Database, Version 1.1. Electronic Database. Task Force Members: Health Canada, U.S. EPA, and the National Agricultural Chemicals Associations, released Feb ruary 1995. The Agricultural Handler Exposure Task Force (AHETF), 2011. The Occupational Handler Unit Exposure Surrogate Reference Table. U.S. EPA. Released June 21, 2011. Data from the Outdoor Residential Exposure Task Force (ORETF). HED Residential Standard Operating Procedures (2012).

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Page **74** of **87 Appendix**  **D . Residential Handler and Post** **- application Exposure and Risk Estimates**  **Table D**  **.1. Residential Handler Short -**  **term Exposure and Risk Estimates for Fluopyram**  **.**
**Use Site Equipment/** 

**Application Method Application**  **Rate 1**  **Area**

**Treated or**  **Am ount**  **Handled Daily**  **2 Exposure** 

**Route Unit** 

**Exposure (m** **g/lb ai) Daily Dose**  **3**

**(m g/k** **g/day) MOE**  **4**

Gardens / Trees Manually
- Pressurized

Handwand 0.00223 lb

ai/gal 5 gal Dermal 63 0.0088 34,000 Inhalation 0.018 0.0000025 5,800,000 Gardens / Trees Manually
- Pressurized

Handwand 0.000005119

lb ai/ft2 1200 ft2 Dermal 63 0.0048 62,000 Inhalation 0.018 0.0000014 10,000,000 Gardens / Trees Hose
- End Sprayer 0.00223 lb ai/gal 11 gal Dermal 58 0.018 17,000 Inhalation 0.0014 0.00000043 34,000,000 Gardens / Trees Hose
- End Sprayer 0.000005119 lb ai/ft2 1200 ft2 Dermal 58 0.0045 67,000 Inhalation 0.0014 0.00000011 130,000,000 Gardens / Trees Backpack 0.00223 lb ai/gal 5 gal Dermal 130 0.018 17,000 Inhalation 0.14 0.000020 740,000 Gardens / Trees Backpack 0.000005119 lb ai/ft2 1200 ft2 Dermal 130 0.010 30,000 Inhalation 0.14 0.000011 1,300,000 Gardens / Trees Sprinkler Can 0.00223 lb ai/gal 5 gal Dermal 58 0.0081 37,000 Inhalation 0.0014 0.00000020 74,000,000 Gardens / Trees Sprinkler Can 0.000005119 lb ai/ft2 1200 ft2 Dermal 58 0.0045 67,000 Inhalation 0.0014 0.00000011 130,000,000 Lawns / Turf Manually
- Pressurized

Handwand 0.00404 lb

ai/gal 5 gal Dermal 63 0.016 19,000 Inhalation 0.018 0.0000045 3,200,000 Lawns / Turf Hose
- End Sprayer 0.404 lb ai/A 0.5 A Dermal 13.4 0.034 8,900 Inhalation 0.022 0.000056 260,000 Lawns / Turf Backpack 0.00404 lb ai/gal 5 gal Dermal 130 0.033 9,100 Inhalation 0.14 0.000035 410,000 Lawns / Turf Sprinkler Can 0.000009285 lb ai / ft2 1000 ft2 Dermal 13.4 0.0016 190,000 Inhalation 0.022 0.0000026 5,700,000 1 Maximum Single Application Rate. 2 Units Treated taken from Science Advisory Council for Exposure, Standard Operating Procedure 9.1, Standard Values for Daily Acres Treated in Agriculture, Rev. 25 SEP 2001. 3 Daily Dose = Unit Exposure x Application Rate x Units Treated  Body Weight (80 kg). 4 Margin Of Exposure (MOE) = NOAEL (mg/kg/day)  Daily Dose (mg/kg/day); where the NOAEL = 300 mg/kg/day for dermal exposure & 14.5 mg/kg/day for inhalation exposure.

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Page **75** of **87 Table**  **D .2. Residential Post**  **- Application Dermal Short**  **- Term** **Exposure and Risk Estimates from Turf.**  **Scenario Application** 

**Rate (lb ai/A) TTR**  **1**

**(μg/cm 2**  **) Exposure** 

**Tim e (hr)**  **Population TC**  **(cm 2** **/hr) Daily Dose**  **2**

**(m g/k** **g/day) MOE**  **3** Golf Course Turf 0.446 0.0496 4 Adults 5,300 0.0131 23,000 Youths 11 to <16 yr old 4,400 0.0153 20,000 Children 6 to <11 yr old 2,900 0.0180 17,000 High Contact Activities 0.404 0.0449 1.5 Adults 180,000 0.152 2,000 Children 1 to <2 yr old 49,000 0.300 1,000 Mowing Turf 0.404 0.0449 1 Adults 5,500 0.00309 97,000 Youths 11 to <16 yr old 4,500 0.00355 85,000 1 TTR derived as follows: 0.446 lb ai/A x 4.54E+8 μg/lb x 2.47E
- 8 A/cm2 x 0.01 (fraction of transferable ai) = 0.0496 μg/cm2 or 0.404 lb ai/A x 4.54E+8 μg/lb x 2.47E
- 8 A/cm2 x 0.01 (fraction of transferable ai) = 0.0449 μg/cm2

. 2 Daily Dose = [TTR (μg/cm2 ) x (0.001 mg/μg) x Dermal Transfer Coefficient x Exposure Time] / [Body weight (80 kg for adults, 57 kg for youths 11 to <16 yr, 32 kg for children 6 to <11 yr, and 11 kg for children 1 to <2 yr old)]. 3 MOE = NOAEL/Daily Dose. Short
- Term NOAEL = 300 mg/kg/day. **Table D**  **.3 . Residential Post**  **- Application Incidental Oral Exposure**  **and Risk Estimates to 1 to <2 Year Olds**  **from Turf.**  **Scenario Application Rate**  **(lb ai/A) Daily Dose (m**  **g/kg/day) MOE**  Hand
- to - Mouth 0.404 0.00615 2,400 Object
- to - Mouth 0.404 0.000187 78,000 Soil Ingestion 0.404 0.000014 1,100,000 1 TTR derived as follows: 0.404 lb ai/A x 4.54E+8 μg/lb x 2.47E
- 8 A/cm2 x 0.01 (fraction of transferable ai) = 0.0449 μg/cm2

. 2 Based on HED’s 2012 Residential SOPs: Lawns/Turf (http://www.epa.gov/pesticides/science/residential
- exposure - sop.html). 3 MOE = NOAEL/Daily Dose. Short
- Term NOAEL = 14.5 mg/kg/day. **Table D**  **. 4**  **. Residential Post**  **- Application Dermal Short**  **- Term** **Exposure and Risk Estimates from Gardens, Ornam**  **entals and Fruit Trees. Scenario**  **Application**

**Rate (lb ai/A) DFR**  **1**

**(μg/cm 2**  **) Exposure** 

**Tim e (hr)**  **Population TC**  **(cm 2** **/hr) Daily Dose**  **2**

**(m g/k** **g/day) MOE**  **3** Gardens 0.223 0.625 2.2 Adults 8,400 0.143 2,100 1.1 Children 6 to <11 yr old 4,600 0.0980 3,100 Trees 0.223 0.625 1.0 Adults 1,700 0.0132 23,000 0.5 Children 6 to <11 yr old 930 0.0090 33,000 1 DFR derived as follows: 0.223 lb ai/A x 4.54E+8 μg/lb x 2.47E
- 8 A/cm2 x 0.25 (fraction of transferable ai) = 0.625 μg/cm2

. 2 Daily Dose = [DFR (μg/cm2 ) x (0.001 mg/μg) x Dermal Transfer Coefficient x Exposure Time] / [Body weight (80 kg for adults and 32 kg for children 6 to <11 yr)]. 3 MOE = NOAEL/Daily Dose. Short
- Term NOAEL = 300 mg/kg/day.

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Page **76** of **87 Appendix**  **E . Occupational**  **Handler and Post -**  **application Exposure/Risk Summary Tables** 
**Table E**  **.1 . Occupational Short** **- and Intermediate**  **- Term Dermal and Inhalation Exposures and Risk**  **Estimates For Fluopyram** Exposure Scenario Crop or Target Maximum Application Rate a (lb ai/A) Ar ea

Treated Daily b (A/day) Unit Exposure d Daily Exposure e (mg/kg/day) MOE f

Baseline Dermal c (mg/lb ai) PPE
- G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE
- G

Dermal Baseline

Inhalation Baseline

Dermal PPE
- G

Dermal Baseline

Inhalation **Mixer/Loader**

Mixing/Loading Li quid Concentrates for Aerial and Chemigation Applications Artichoke (globe); Brassica (cole)

Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Small Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low
- Growing Berries 0.22 2 350

0.22 0.0376 0.219 0.214 0.0365 2
. 13 E
- 4 1,400 8,200 68,000

Brassica Leafy Vegetables Head and

Stem Subgroup 0.125 350 0.120 0.0206 1
. 20 E
- 4 2,500 15,000 120,000 Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean) ; Potato; Sugar Beet; Sunflower

subgroup 0.22 2 1200 0.733 0.125 7
. 29 E
- 4 410 2,400 20,000 Nursery (ornamentals, vegetables, trees, container stock) 0.131 60 0.0216 0.00370 2
. 15 E
- 5 14,000 81,000 670,000 Sod 0.446 350 0.429 0.0734 4
. 28 E
- 4 700 4,100 34,000

Mixing/Loading Li quids Concentrates for Gr oundboom Applications Artichoke (globe); Brassica (cole)

Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Smal l Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low
- Growing Berries 0.222 80 0.22 0.0376 0.219 0.0489 0.00835 4
. 86 E
- 5 6,00 36,000 300,000

Brassica Leafy Vegetables Head and 0.125 80 0.0275 0.00470 2
. 7 4E
- 5 11,000 64,000 530,000

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Page **77** of **87 Table**  **E .1**  **. Occupational Short -**  **and Intermediate -**  **Term Dermal and Inhalation Exposures and Risk Estimates For Fluopyram**  Exposure Scenario Crop or Target Maximum Application Rate a (lb ai/A) Ar ea

Treated Daily b (A/day) Unit Exposure d Daily Exposure e (mg/kg/day) MOE f

Baseline Dermal c (mg/lb ai) PPE
- G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE
- G

Dermal Baseline

Inhalation Baseline

Dermal PPE
- G

Dermal Baseline

Inhalation Stem Subgroup Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean) ; Potato; Sugar Beet; Sunflower

subgroup 0.222 200 0.122 0.0209 1
. 22 E
- 4 2,500 14,000 120,000
Field Grown Ornamentals 0.131 40 0.0144 0.00246 1
. 44 E
- 5 21,000 120,000 1
. 0 E+6 Nursery (ornamentals, vegetables, trees, container stock) 0.131 60 0.0216 0.0037 2
. 15 E
- 5 14,000 81,000 670,000 Sod 0.446 80 0.0981 0.0168 9
. 76 E
- 5 3,100 18,000 150,000 Turf 0.446 40 0.0490 0.00839 4
. 89 E
- 5 6,100 36,000 300,000 Mixing/Loading Li quids Concentrates for Airblast Applications Nursery (ornamentals, vegetables, trees, container stock) 0. 131 2 0 0.22 0.0376 0.219 0.00720 0.00123 7
. 18 E
- 6 42,000 240,000 2
. 0 E+6 Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Pome Fruit; Stone Fruit; 0.222 40 0.0244 0.00418 2
. 43 E
- 5 12,000 72,000 600,000 **Applicator**

Applying Sprays via Aerial Equipment Artichoke (globe); Brassica (cole)

Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Smal l Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low
- Growing Berries 0.22 2 350

0.00 208 g No Data 0.0 049 g 0.00203 No Data 4
. 76 E
- 6 150,000 No Data 3
. 0 E+6

Brassica Leafy Vegetables Head and

Stem Subgroup 0.125 350 0.00114 No Data 2
. 68 E
- 6 260,000 No Data 5
. 4 E+6 Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean) ; Potato; Sugar Beet; Sunflower

subgroup 0.22 1200 0.00693 No Data 1
. 64 E
- 5 43,000 No Data 880,000 Nursery (ornamentals, vegetables, trees, container stock) 0.131 60 0.000204 No Data 4
. 81 E
- 7 1
. 5 E+6 No Data 3
. 0 E+7 Sod 0.446 350 0.00406 No Data 9.56E
- 6 74,000 No Data 1.5E+6 Applying Artichoke (globe); Brassica (cole) 0.222 80 0.0 786 0.01 61 0. 3 4 0.0175 0.00358 7.55E
- 5 17,000 84,000 190,000

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Page **78** of **87 Table**  **E .1**  **. Occupational Short -**  **and Intermediate -**  **Term Dermal and Inhalation Exposures and Risk Estimates For Fluopyram**  Exposure Scenario Crop or Target Maximum Application Rate a (lb ai/A) Ar ea

Treated Daily b (A/day) Unit Exposure d Daily Exposure e (mg/kg/day) MOE f

Baseline Dermal c (mg/lb ai) PPE
- G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE
- G

Dermal Baseline

Inhalation Baseline

Dermal PPE
- G

Dermal Baseline

Inhalation Sprays via Gr oundboom Equipment Leafy Vegetables; Bulb Vegetables;

Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Small Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low
- Growing Berries Brassica Leafy Vegetables Head and

Stem Subgroup 0.125 80 0.00983 0.00201 4.25E
- 5 31,000 150,000 340,000 Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton; Legume Vegetables (including Soybean) ; Potato; Sugar Beet; Sunflower

subgroup 0.222 200 0.0436 0.00894 1.89E
- 4 6,900 34,000 77,000
Field Grown Ornamentals 0.131 40 0.00515 0.00106 2.23E
- 5 58,000 280,000 650,000 Nursery (ornamentals, vegetables, trees, container stock) 0.131 60 0.00773 0.00159 3.34E
- 5 39,000 190,000 430,000 Sod 0.446 80 0.0175 0.00359 7.59E
- 5 17,000 84,000 190,000 Turf 0.446 40 0.0350 0.00718 1.51E
- 4 8,600 42,000 96,000 Applying Sprays via Airblast Equipment Nursery (ornamentals, vegetables,

trees, container stock) 0.22 2 2 0 1.77 1.59 4. 71 0.0580 0.0521 1.54E
- 4 5,200 5,800 94,000 Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Pome Fruit; Stone Fruit 0.131 40 0.196 0.176 5.23E
- 4 1,500 1,700 28,000 **Flagger**

Flagging for Aerial Sprays Applications Artichoke (globe); Brassica (cole)

Leafy Vegetables; Bulb Vegetables; Carrot; Citrus; Cucurbit Vegetables; Fruiting Vegetables; Ginseng; Grapes and Small Vine Fruits (except Fuzzy Kiwifruit); Herbs and Spices (except Black Pepper); Hops; Leafy Vegetables; Pome Fruit; Other Root, Tuberous and Corm Vegetables; Small Berries (Caneberries and Bushberries); Stone Fruit; Strawberry and Other Low
- Growing Berries 0.22 2 350 0.011 0.012 0.35 0.0107 0.0117 3.40E
- 4 28,000 26,000 43,000

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Page **79** of **87 Table**  **E .1**  **. Occupational Short -**  **and Intermediate -**  **Term Dermal and Inhalation Exposures and Risk Estimates For Fluopyram**  Exposure Scenario Crop or Target Maximum Application Rate a (lb ai/A) Ar ea

Treated Daily b (A/day) Unit Exposure d Daily Exposure e (mg/kg/day) MOE f

Baseline Dermal c (mg/lb ai) PPE
- G

Dermal c (mg/lb ai) Baseline

Inhalation c (μg/lb ai) Baseline

Dermal PPE
- G

Dermal Baseline

Inhalation Baseline

Dermal PPE
- G

Dermal Baseline

Inhalation Brassica Leafy Vegetables Head and

Stem Subgroup 0.125 350 0.00601 0.00656 1.91E
- 4 50,000 46,000 76,000 Canola Subgroup; Cereal grains; Forage, Fodder, or Straw from Cereal Grains; Cotton Legume Vegetables (including Soybean) ; Potato; Sugar Beet; Sunflower

subgroup 0.22 1200 0.0366 0.040 0.00117 8,200 7,500 12,000 Nursery (ornamentals, vegetables, trees, container stock) 0.131 60 0.00108 0.00118 3.44E
- 5 280,000 250,000 420,000 Sod 0.446 350 0.0215 0.0234 6.83E
- 4 14,000 13,000 21,000 **Mixer/Loader/Applicator** Mixing/Loading /Applying Li quid Concentrates with Manually Pressurized Handwand Gr eenhouse Ornamentals 0.00131 lb ai/gal 40 gal 100 0.43 30 0.0655 2.81E
- 4 1.96E
- 5 4,600 1.1E+6 740,000 Nursery (ornamentals, vegetables, trees, container stock) 0.00131 lb ai/gal 0.0655 2.81E
- 4 1.96E
- 5 4,600 1.1E+6 740,000 Christmas Trees 0.00223 lb ai/gal 0.112 4.80E
- 4 3.35E
- 5 2,700 630,000 430,000 Turf 0.0026 lb ai/gal 0.130 5.59E
- 4 3.90E
- 5 2,300 540,000 370,000 Mixing/Loading /Applying Li quid Concentrates with Mechanically
Pressurized Handgun Gr eenhouse Ornamentals 0.00131 lb ai/gal 1000

gal 3.5 2.5 120 0.0574 0.0410 0.00196 5,200 7,300 7,400 Nursery (ornamentals, vegetables, trees, container stock) 0.00131 lb ai/gal 1000

gal 1.3 0.39 3.9 0.0213 0.00639 6.39E
- 5 14,000 47,000 230,000 Christmas Trees 0.00223 lb ai/gal 1000

gal 0.0363 0.0109 1.09E
- 4 8,300 28,000 130,000 Pome Fruit; Stone Fruit 0.0222 lb ai/gal 1000

gal 0.361 0.108 0.00108 830 2,800 13,000 Golf Course; Turf 0.446 5 1.14 0.88 1.9 0.0318 0.0245 5.30E
- 5 9,400 12,000 270,000 Mixing/Loading /Applying Li quid Concentrates with a Backpack Nursery (ornamentals, vegetables,

trees, container stock) 0.00131 lb ai/gal 40 gal 13.2 11.2 140 0.00865 0.00734 1.98E
- 5 35,000 41,000 160,000 Christmas Trees 0.00223 lb ai/gal 0.0148 0.0125 1.56E
- 4 20,000 24,000 93,000 Pome Fruit; Stone Fruit 0.0222 lb ai/gal 8.26 8.26 2.58 0.0916 0.0916 2.86E
- 5 3,300 3,300 510,000 Turf 0.0026 lb ai/gal 0.0107 0.0107 3.35E
- 6 28,000 28,000 4.3E+6 a. Application Rates are based on proposed uses from the fluopyram labels. b. Science Advisory Council Policy No. 9.1. c. Baseline Dermal: Long
- sl eeve shirt, long pants, and no gloves. PPE
- G Dermal: Baseline plus chemical
- resistant gloves. Baseline Inhalation: no respirator.

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Page **80** of **87** d. Unit Exposures are based on “Occupational Pesticide Handler Unit Exposure Surrogate Table”. e. Daily Exposure (mg/kg/day) = Application Rate (lb ai/A) * Unit Exposure (mg/lb ai) *Area Treated or Amount Applied (acre/day) / 8 0 kg. f. MOE = NOAEL (mg/kg/day) / Daily Exposure (mg/kg/day); where dermal NOAEL = 300 mg/kg/day and inhalation NOAEL = 14.5 mg/kg/day. g. Engineering control unit exposure for applying sprays via aerial equipment = enc losed cockpit.

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Page **81** of **87 Table**  **E .2. Summary of**  **Short -**  **and Interm ediate**  **- Term Handler Exposures and Risk Estim**  **ates for Fluopyram** **Seed Treatment of Peanut Seed.** a Maximum Application Rate b lb ai/lb seed Amount of

Seed Treated or Planted Per Dayd lb seed/day Dermal

Unit Exposure c mg/lb Inhalation

Unit Exposure c mg/lb Dermal

Dose e mg/kg/day Inhalation

Dose f mg/kg/day Dermal

MOE f LOC = 100 Inhalation

MOE h LOC = 100 **Loader/Applicator** 0.001245 339,500 0.023 0.00034 0.1215 0.001796 2,500 8,100 **Sewer** 0.001245 339,500 0.0062 0.00023 0.03276 0.001215 9,200 12,000 **Bagger** 0.001245 339,500 0.0091 0.00016 0.04808 0.0008454 6,200 17,000 **Multiple Activities** 0.001245 339,500 0.042 0.0016 0.2219 0.008454 1,400 1,700 **Planters** 0.001245 18,260 0.25 0.0034 0.07104 0.0009662 4,200 15,000
a Seed treatment rate calculations are based on the following assumptions: Peanut: 460 seeds per lb; 228 lb of seed planted per acre, 80 acres planted per day. b Application Rate based on proposed label for fluopyram (Luna Privilege, EPA Reg. No. 264
- 1078). c Unit Exposures from HED Exposure Science Advisory Council Policy 14: Standard Operating Procedures for Seed Treatment (baseline inhalation = no respirator; dermal unit exposure includes PPE with gloves for loading/appli cator, multiple activities and planter scenarios). d HED default for lb seed treated/planted per day from HED Exposure Science Advisory Council I nterim Policy 15.1 and the BEAD m emo “Acres Planted Per Day and Seeding Rates of Crops Grown in the United States” (J. Becker, March 2011). e Daily Dermal Dose (mg/kg/day) = daily dermal unit exposure (mg/lb ai) × application rate (lb ai/lb seed) × amount planted (lb seed/day) ÷ body weight (80 kg adult). f Daily I nhalation Dose (mg/kg/day) = daily inhalation unit exposure (mg/lb ai) × application rate (lb ai/lb seed) × amount planted (lb seed/day) ÷ body weight (80 kg adult). g Dermal MOE = NOAEL (300 mg/kg/day for short
- and intermediate
- term exposure) ÷ Dermal Dose (mg/kg/day). Level of concern = 100. h Inh alation MOE = NOAEL (14.5 mg/kg/day for short
- and intermediate
- term exposure) ÷ I nhalation Dose (mg/kg/day). Level of concern = 100.

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Page **82** of **87 Table**  **E .3. Summary of Occupational Non**  **- Cancer Post** **- application Risks (Short** **- and Intermediate**  **- Term) with HED**  **Default Assumptions.** Crops or Crop Groups Application

Rate (lb ai/acre) Default DFR on 0

days (12 hr) after application a (μg/cm2 ) Work Activity &

Maximum Transfer Coefficient b (cm2/hr) Daily Dose c

(mg/kg/day) MOE d

(LOC = 100) Artichoke 0.222 0.622 1900 Irrigation (Hand Set) 0.118 2,500 Brassica Leafy Vegetables Head & Stem Subgroup 0.125 0.350 4200 Hand Harvesting, Hand Weeding, Scouting, Topping, Tying/Training 0.147 2,000 Brassica Leafy Vegetables 0.222 0.622 4200 Hand Weeding 0.261 1,100 Bulb Vegetables 0.222 0.622 4200 Hand Weeding 0.261 1,100 Canola Subgroup 0.222 0.622 1100 Scouting 0.0684 4,400 Carrot 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Sweet Corn 0.222 0.622 17,600 Hand Detasseling, Hand Harvesting 1.09 270 Cereal Grains 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Forage, Fodder or Straw from Cereal Grains 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Citrus 0.222 0.622 1400 Hand Harvesting 0.0871 3,400 Cotton 0.222 0.622 210 Scouting 0.0131 23,000 Cucurbits 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Fruiting Vegetables 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Okra 0.167 0.468 1900 I rrigation (Hand Set) 0.0889 3,400 Ginseng 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Small Vine Fruits 0.222 0.622 10,100 Hand Harvesting 0.628 480 Herbs & Spices 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Hops 0.222 0.622 19,300 Harvesting, Mechanically Assisted 1.20 250 Leafy Vegetables 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Legume Vegetables 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Soybean 0.222 0.622 1100 Scouting 0.0684 4,400 Pome Fruit 0.222 0.622 3600 Thinning Fruit 0.224 1,300 Root, Tuberous & Corm Vegetables 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Small Berries 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Stone Fruit 0.222 0.622 3600 Thinning Fruit 0.224 1,300 Low Growing Berries 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Sugar Beet 0.222 0.622 1100 Hand Harvesting 0.0684 4,400 Sunflower 0.222 0.622 1900 I rrigation (Hand Set) 0.118 2,500 Christmas Trees 0.223 0.625 1900 I rrigation (Hand Set) 0.119 2,500 Nursery Ornamentals 0.131 0.367 1900 I rrigation (Hand Set) 0.0697 4,300 a. Default DFR (μg/cm2 ) = application rate (lb ai/A) x (1
- daily dissipation rate) t x 4.54E+8 μg/lb x 24.7E
- 9 A/c m 2 x 25% DFR after initial treatment. b. Crops were assessed using the highest transfer coefficient (TC) available. c. Daily Dose = DFR x TC x (1 mg/1000 μg) x ET (8 hr/day) / body weight (80 kg) d. MOE = NOAEL (300 mg/kg/day) / Daily Dose (mg/kg/day)

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Page **83** of **87 Table**  **E .**  **5 . Anticipated Post**  **- Application Activities and Transfer Coefficients for Cotton Harvesters.**  **Crop Policy Crop** 

**Group Category Crop** 

**Height Foliage** 

**Density Transfer C**  **oefficients Activities** 

Cotton Field / row . crop,

low / medium High Min 900 g cotton boll/hr Mechanical Harvesting (Module Builder Operator) 2,400 g cotton boll/hr Mechanical Harvesting (Picker Operator and Raker) 5,050 g cotton boll/hr Mechanical Harvesting (Tramper)

**Table E**  **. 6. Occupational**  **Post -**  **application Exposure and Risk Estimates for Cotton Harvesting**  **Activities. Mechanical Harvesting Activity**  **Appl. Rate (lb ai/A)**  **DBR**

**(μg/g) 1**  **Transfer**

**Coefficient (g/hr)**  **2 Derm**  **al Dose 3** 

**(m g/kg/day)**  **Derm al** 

**MOE 4**  Module Builder Operator 0.222 0.000194 900 0.0000175 17,000,000 Picker Operator and Raker 2,400 0.0000466 6,400,000 Tram per 5,0500 0.0000981 3,100,000 1. Cotton Harvesting Dislodgeable Boll Residue (DBR) = (Best fit DBR at 30 days MRID# 42701601 (0.082 μg/50g = 0.00164 μg/g) x Application Rate (0.222 lb ai/A)) / Study Application Rate (1.875 lb ai/A) = 0.000194 μg/g 2. From Non
- Foliar Transfer Coefficient Table: http://epa.gov/pesticides/science/exposac
- policy
- 3
- march2013.pdf 3. Daily Dose (mg/kg/day) = [DBR x Transfer Coefficient x Conv. Factor (0.001 mg/μg) x 8 hr/day] / Body Weight (80 kg). 4: Short
- & Intermediate
- term Margin of Exposure (MOE) = Short
- term Dermal NOAEL (300 mg/kg/day) / Daily Dose (mg/kg/day).
**Table E**  **.7 . Exposure and Risk Assessment for Occupational Post**  **- Application Activities on Turf.**  **Application Rate (lb ai/A)**  **Dermal Transfer Coefficient**

**(cm 2** **/hr) & Activities 1**  **Post Application**  **Day (t) Turf** 

**Transferable Residue**  **(TTR) 2**  **(μg/cm 2**  **) Daily Dose**  **3**

**(m g/k** **g/day) Short** **- &** 

**Intermediate**

**- Term**  **Dermal MOE**  **4** 0.446 6,700 (Maintenance,

Transplanting/Planting, & Harvesting Sod) 0 0.05 0.0335 9,000
1 The transfer coefficient is the arithmetic mean value taken from MRID 46734001. It should be noted that a previous study on golf course maintenance (MRID 45530101) had been submitted, but had been determined to be unacceptable. Data from MRID 46734001 are believed to be more appropriate. 2 TTR derived as follows: 0.446 lb ai/A x 4.54E+8 μg/lb x 2.47E
- 8 A/cm2 x 0.01 (fraction of transferable ai) = 0.05 μg/cm2

. 3 Daily Dose = [TTR (μg/cm2 ) x (0.001 mg/μg) x Dermal Transfer Coefficient x Exposure Time (8 hr) ] / [Body Weight (80 kg)] = 0.0335 mg/kg/day. 4 MOE = LOAEL/Daily Dose. Short
- /Intermediate
- Term LOAEL = 300 mg/kg/day.

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Page **84** of **87 Appendix**  **F .**  **International Residue Limit Status Sheet** 

## Fluopyram (080302 ) International Residue Limits Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 

### Codex 3 40 CFR 180.661 (1) Plants: fluopyram (N
- [2
- [3
- chloro
- 5
- (trifluoromethyl)
- 2
-py

ridinyl]ethyl]
- 2
- (trifluoromethyl)benzamide) N
- [2
- [3
- chloro
- 5
- (trifluoromethyl)
- 2
- pyridinyl] ethyl]
- 2
- (trifluoromethyl)benzamide Plants: fluopyram


### Commodity 1 

### Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 2 

### Codex 3 Artichoke, globe 4.0 4 Grain, aspirated grain fractions 50 None Peanut 0.20 0.2 0.03 Hop, dried cones 60 60 Vegetable, root, except sugar beet, subgroup 1B 0.30 0.3 0.4 carrot Sugarbeet, roots 0.10 0.10 0.04 Vegetable, tuberous and corm, subgroup 1C 0.10 0.1 0.03 potato Potato, wet peel 0.30 None Vegetable, leaves of root and tuber, group 2 30 30 Onion, bulb, subgroup 3
- 07A 0.40 0.4 0.07 garlic, onion bulb Onion, green, subgroup 3
- 07B 15 15 50 fresh chive leaves 0.15 leek Leafy greens subgroup 4A 40 40 15 lettuce (head and leaf) Leaf petioles s ubgroup 4B 20 20 Brassica, head and stem, subgroup 5A 4.0 4 0.3 broccoli, Brussels sprout 0.15 cabbage (head) 0.09 cauliflower Brassica, leafy greens, subgroup 5B 50 50 Soy bean, seed 0.30 0.2 Vegetable, legume, edible podded, subgroup 6A 4.0 4 Pea and bean, succulent shelled, subgroup 6B 0.20 0.2 Bean, dry 0.15 0.7 crop subgroup 6C 0.07 beans, chick
-pea, lentil, lupin (all dry) Tomato subgroup 8
- 10A 1.0 0.5 0.4 tomato

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Page **85** of **87** Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 

### Codex 3 Pepper/eggplant subgroup 8
- 10B 4.0 4 0.5 peppers (proposed) 5 peppers chili, dried (proposed) Melon subgroup 9A 1.0 1 Squash/cucumber subgroup 9B 0.60 0.3 0.5 cucumber Fruit, citrus, group 10
- 10 1.0 1 Citrus, oil 8 8 Fruit, pome, group 11
- 10 0.80 0.8 0.5 Cherry subgroup 12
- 12A 2.0 2 0.7 cherries Peach subgroup 12
- 12B 1.0 1 1 Plum subgroup 12
- 12C 0.50 0.5 0.5 (including prunes) Caneberry subgroup 13
- 07A 5.0 5 3 blackberries, raspberries (red, black) Bushberry subgroup 13
- 07B 7.0 7 Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13
- 07F 2.0 2 2 grapes
Grape, rai sin 3.0 3 5 dried grapes (=currants, raisins and sultanas) Berry, low

growing, except cranberry, subgroup 13
- 07G 2.0 2 0.4 straw berry Nut, tree, group 14
- 12 0.05 0.05 0.04 Almond, hulls 10 10 Grain, cereal, group 15 except corn and rice 4.0 1.5 Corn, field grain 0.02 Corn, pop, grain 0.02 Corn, sweet, kernel plus cob with husks removed 0.01 Grain, cereal, forage, fodder and straw, except rice, group 16 20 20 Herb subgroup 19A 40 70
- fresh 400 dried Dill, seed (including caraway , seed; celery

, seed; coriander, seed

; lovage, seed; mustard

, seed; poppy

, seed 70 70 Rapeseed subgroup 20A 5.0 1.8 1 Sunflower subgroup 20B 0.70 0.7

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Page **86** of **87** Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 

### Codex 3 Cottonseed subgroup 20C 0.80 0.8 Cotton, gin by
-products 30 30 40 CFR 180.661 (2) Livestock: sum of fluopyram (N
- [2
- [3
- chloro
- 5
- (trifluoromethyl)
- 2
-py

ridinyl]ethyl]
- 2
- (trifluoromethyl)benzamide) and its benzamide metabolite [2
- (trifluoromethyl)
-benzamide], calculated as the stoichiometric equivalent of fluopyram Livestock: sum of fluopyram (N
- [2
- [3
- chloro
5
- (trifluoromethyl)
- 2
- pyridinyl]ethyl]
- 2
- (trifluoromethyl)benzamide ) and its benzamide metabolite [2
- (trifluoromethyl)
- benzamide], calculated as the stoichiometric equivalent of fluopyram Animal commodities: Sum of fluopyram and 2
- (trifluoromethyl)benzamid e, expressed as Fluopyram



### Commodity 1 

### Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 2 

### Codex 3 Cattle, fat 0.70 1.5 Cattle, meat 0.80 1.5 0.5 Meat (from mammals other than marine mammals) Cattle, meat byproducts 7.5 10 0.5 kidney 3 liver Egg 0.08 0.3 Hog, fat 0.20 Hog, meat 0.02 0.5 Meat (from mammals other than marine mammals) Hog, meat byproducts 0.20 0.06 0.5 kidney 3 liver Milk 0.40 2 0.3 Poultry, fat 0.04 0.05 Poultry, meat 0.04 0.2 Poultry, meat byproducts 0.16 0.15 0.7 Goat, fat 0.70 1.5 Goat, meat 0.80 1.5 0.5 Meat (from mammals other than marine mammals) Goat, meat byproducts 7.5 10 0.5 kidney 3 liver Horse, fat 0.70 1.5 Horse, meat 0.80 1.5 0.5 Meat (from mammals other than marine mammals) Horse, meat byproducts 7.5 10 Sheep, fat 0.70 1.5 Sheep, meat 0.80 1.5 0.5 Meat (from mammals other than marine mammals)

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Page **87** of **87** Summary of US and International Tolerances and Maximum Residue Limits Residue Definition : US Canada Mexico 2 

### Codex 3 Sheep, meat byproducts 7.5 10 0.5 kidney 3 liver 

### US Canada Mexic o 2 

### Codex 3 40CFR§180.661 (d) Indirect or inadvertent residues 

### Commodity 1 

### Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexic o 2 

### Codex 3 Sugarcane, cane 0.08 0.08 Com pleted: M. Negussie; 09/24/2015
1 Includes only commodities of interest for this action. Tolerance values should be the HED recommendations and not those proposed by the applicant.
2 Mexico adopts US tolerances and/or Codex MRLs for its export purposes. 3 * = absent at the limit of quantitation; Po = postharvest treatment, such as treatment of stored grains. PoP = processed postharvest treated commodity, such as processing of treated stored wheat. (fat) = to be measured on the fat portion of the sample. MRLs indicated as proposed have not been finalized by the CCPR and the CAC
.