**UNITED STA TES ENVIRONMENTA**  **L PROTECTION A GENCY**  **WA SHINGTON, D.C. 20460**  **OFFICE OF CHEMICAL SAFETY**  **AND POLLUTION PREVENTION**  **Date** : 20 - AUG - 2014 **Subject: Pyrimethanil**  **.** Occupational and Residential Exposure Assessment for a

Proposed Post - Harvest Use on Pomegranates. **PC Code:** 288201 **DP Barcode:** D 417166 **Decision No.:** 484376 **Registration No. :**  43813 - 32 **Petition No.:** 3F8213 **Regulatory Action:** Section 3 **Risk Assessment Type:** Occupational/Residential Exposure Assessment **Case No.:** 7059 T **XR No.:** NA **CAS No.:** 53112 - 28 - 0 **MRID No.:** NA **40 CFR:** §180.518 **From:** Jennifer R. Tyler, Chemist

Registration Action Branch (RAB1) /Health Effects Division ( HED; 7509P) **Through:** Kelly

L owe, Environmental Scientist Charles W. Smith III, Branch Chief RAB1/HED (7509P) and Cassi Walls, Ph.D., Senior Biologist Barry O’Keefe, Senior Biologist Exposure Science Advisory Committee (ExpoSAC) /HED **To:** Hope Johnson

Branch/Registration Division ( RD; 7505 P) **Introduction** RD has requested that HED conduct an e xposure and risk assessment for the post - harvest use of py ri methanil on pomegranates. It is HED policy to use the best available data to assess exposure. Several sources of generic data were used in this assessment as surrogate data in the absence of chemical - specific data, including the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) databas e; and the HED ExpoSAC Policy Guidance “Assessment of Occupational Exposure for Post - Harvest Commodity Pesticide Treatments . ” Some of these data are proprietary , and subject to the data protection provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). **Note:** This memorandum was reviewed by the Exposure Science Advisory Committee (ExpoSAC) on 17 - JUL - 2014 .Page 2 of 10 **Table of Contents** 1.0 Executive Summary ................................ ................................ ................................ ............. 3 2.0 Risk Assessment Conclusions and Recommendations ................................ ........................ 4 3.0 Hazard Characterization ................................ ................................ ................................ ....... 4 4. 0 Use Profile ................................ ................................ ................................ ........................... 5 5.0 Residential Exposure and Risk Estimates ................................ ................................ ............ 5 6.0 Occupational Exposure and Risk Estimates ................................ ................................ ........ 5 6.1 Occupational Handler Exposure/Risk Estimates ................................ .............................. 5 6.2 Occupational Post - application Exposure/Risk Estimates ................................ ................ 8 Appendix A. Summary

of Occupational and Residential Non - cancer Algorithms ..................... 10Page 3 of 10

**1.0 Executive Summary**  This document presents an occupational and residential exposure/risk assessment for the proposed post - harvest application of py rimethanil to pomegranates. There are currentl y no registered or proposed residential uses for p yrimethanil. Use Summary : P yrimethanil is currentl y registered as an anilinopy rimidine fungicide that inhibits the secretion of fungal enzy mes which are required during the infection process. The petition submitted by

the registrant includes adding pomegranates to the Penbotec ® 400 SC product label (EPA Reg. # 43813 - 32 ). This product is formulated as a soluble concentrate (SC) and is proposed at a maximum rate of 0.82 pounds (lb) active ingredient (ai)/100 gal via in - line dip/drench wash tanks. Applications can be made to the fruit on the same day as sold or consumed . Hazard and Dose Response Summary : HED identified short - and intermediate - term dermal and inhalation toxicological endpoints from a reproduction study in the rat. The no - observed - adverse effect - level (NOAEL) is 23.1 mg/kg bw/day based on decreased mean bo dy weights and body weight gains. A dermal absorption factor of 51% was used for the exposure assessment. N o inhalatio n absorption data are available; therefore, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure. The average adult body weight of 80 kg was used for estimating inhalation and dermal dose s . A margin of exposure (MOE) of 100 does not exceed the Agency ’s level of concern (LOC). Py rimethanil has been reclassified as "Not Li kely to be Carcinogenic at doses that do not pertubate thy roid hormone stimulation." Occupational Handler Exposure/ Risk : Based on the proposed use, i t is anticipated that there will be occupation al handler short - and intermediate - term dermal and inhalati on exposures . Chronic exposure is not expected for the proposed uses. Dermal and inhalation risk estimate s for occupational handlers are above the LOC (100) with label - required personal protective equipment ( PPE ) (i.e., long - sleeved shirt, long pants, shoes plus socks and chemical resistant gloves ) ; and, therefore, are not of concern. Occupational Post-

Application Exposure/

Risk : Based on the proposed use pattern, HED expects post - application dermal and inhalation exposure to workers while sorting and packing treated pomegranates , as well as indirect inhalation exposure for workers present in the warehouse, but not directly

involved in the treatment process. The short - and intermediate - term risk estimates are not of concern (i.e., MOEs ≥100) at baselin e ( i.e., t - shirt and no gloves and no respirator) for all post - ap plication exposure activities . Residential Exposure/Risk : Currently , there are no registered/proposed uses of py rimethanil that result in residential exposures. Therefore, a quantitative residential exposure assessment was not performed. Human Studies Review : 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 data, which include studie s from PHED 1.1; the AHETF database; and the ARTF database; are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant withPage 4 of 10

applicable ethics requirements. For certain studies, the ethics review may have i ncluded review by the Human Studies Review Board. Descriptions of data sources, as well as guidance on their use, can be found at the Agency website 1

. **2.0 Risk Assessment Conclusions and Recommendations**  There are no short - and intermediate - term occupational risk estimates of concern associated with the proposed new use of py rimethanil . There are no data gaps in the exposure database. **3 .0**  **Hazard Characterization**  Acute Toxicity : Table 3.0.1 provides a summary of the acute toxicity

of py rimethanil. Py rimethanil is of low acute toxicity by oral, dermal, and inhalation routes, a slight eye irritant, not irritating to the skin, and not a dermal sensitizer. **Table 3.0.1. Acut e Toxicity Profile**  **– Pyrim**  **ethanil .**  **Guideline No./Study Type MRID No.**  **Results Toxicity Category**  870.1100/Acute oral toxicity 43345002 LD 50 = 4149 mg/kg, M 5971 mg/kg, F III 870.1200/Acute dermal toxicity 43345003 LD 50 >5000 mg/kg IV 870.1300/Acute inhalation toxicity 43301604 LC 50 >1.98 mg/L III 870.2400/Primary eye irritation 43345004 slight eye irritant IV 870.2500/Primary dermal irritation 43345005 non irritant IV 870.2600/Dermal sensitization 43301605 not a sensitizer Toxicological PODs Used for Risk Assessment : Toxicological doses selected for use in this assessment are summarized in Table 3.0.2. HED identified short - and intermediate - term dermal and inhalation toxicological endpoints from a reproduction study in the rat. The NOAEL is 23.1 mg/kg bw/day

based on decreased mean body weights and body weight gains. A route - specific inhalation study

is not available for py

rimethanil. Howeve r , the HED HASPOC looked at all existing hazard and exposure data, and current use patterns for p yrimethanil, and used a weight of - evidence (WOE) approach to conclude that subchronic inhalation toxicity study is not required for p yrimethanil at this time (Memo , J. Van Alstine, 8 - FEB - 2013; TXR# 0056470 ). A dermal absorption factor of 51 % was used for the exposure assessment and is based on decreased mean body weights and body- weight gains . Since no inhalation absorption data are available, toxicity by the inhalation route is considered to be equivalent to the estimated toxicity by the oral route of exposure. The standard body weight for the general population (80 kg) was used for all exposure scenarios covered in this risk assessment since the endpoints selected were not developmental and/or fetal effects. An MOE of 100 do es not exceed the Agency ’s LOC. P yrimethanil has been reclassified as "Not Likel y to be Carcinogenic at doses that do not pertubate thyroid hormone stimulation."

1 http://www.epa.gov/pesticides/science/handler - exposure - data.html and http://www.epa.gov/pesticides/science/post - app - exposure - data.htmlPage 5 of 10

**Table 3.0.2 . Summary of**  **Toxicological Doses and Endpoints for Pyrim ethanil for Use in Occupational Human**  **- Health**  **Risk Assessments .**  **1 Exposure**  **Scenario Point of Departure**  **FQPA SF* and LOC** **for Risk Assessment Study and Toxicological Effects**  Short (1 - 30 days) and Intermediate (1 - 6 months) Term Dermal Oral NOAEL= 23.1 mg/kg/day (dermal absorption = 51 %) Occupational LOC for MOE = 100 Reproductive Toxicity - Rat LOAEL = 294 mg/kg/day based on decreased mean body weights and body- weight gains. Short (1 - 30 days) and Intermediate (1 - 6 months) Term Inhalation Oral NOAEL= 23.1 mg/kg/day (inhalation absorption = 100 %) Occupational LOC for MOE = 100 Reproductive Toxicity - Rat LOAEL = 294 mg/kg/day based on decreased mean body weights and body- weight gains. Cancer (oral, dermal, inhalati on) In accordance with the EPA’s Final Guidelines for Carcinogen Risk Assessment (March 2005), the CARC classified pyrimethanil as “ **Not Likely To Be Carcinogenic To Humans At Doses That Do Not Alter Rat Thyroid Hormone Homeostasis”**  (TXR#0056151, J. Rowland , 23/DEC/2012). 1. 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. FQPA SF = FQPA Safety Factor. MOE = margin of exposure. LOC = level of concern. **4 .0**  **Use Profile** Table 4.0.1 provides a summary of the proposed use p atterns. Penbotec ® 400SC is formulated as a SC, and is proposed at a maximum application rate of 32 fl oz formulation/100 gal water, water - wax , or wax - oil emulsion ( 0.82 lb ai/100 gal ; 0.1% ai in solution) via in - line dip/drench wash tanks to harvested pomegranates . A single post - harvest application is permitted. There is no post - treatment interval prior to human consumption. The product label requires applicator s and other handlers to wear PPE which con sists of long - sleeved shirt, long pants, shoes plus socks and chemical resistant gloves. **Table 4 .0.1. Summary of Proposed Directions for Use of Pyrimethanil.**  **Commodity Trade Name (EPA** 

**Reg. No.) Application** 

**Tim ing, Type,**  **Equipment Application** 

**Rate (lb**  **ai/100 gal) Ma** **xim um Seasonal** 

**Application Rate (lb ai/100 gal)**  **PHI 1** 

**(days) RTI**  **2 (days)**  **Min.**

**GPA 3**  Pomegranates Penbotec ® 400 SC

(43813 - 32) In - line

dip/drench 0.82 0.82 NA NA NA 1. PHI = preharvest interval. 2. RTI = retreatment interval. 3. GPA = gallons of water per acre. 4. NA = not applicable . **5 .0**  **Residential Exposure and Risk Estimates**  Currently , there are no registered/proposed uses of py rimethanil that result in residential exposures. Therefore, a quantitative residential exposure assess ment was not performed. **6 .0**  **Occupational Exposure and Risk Estimates**  **6 .1**  **Occupational Handler Exposure/Risk Estimates**  HED uses the term handlers to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related toPage 6 of 10

applications and exposures can vary depending on the specifics of each t ask. Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used b y a handler can cause exposure levels to differ in a manner specific to each application event. Based on the anticipated use patterns and current labeling, typ es of equipment and techniques that can potentially

be used, occupational handler exposure is expected from the proposed uses. The quantitative exposure/risk assessment developed for occupational handlers is based on the m ixing/loading liquids for automated s ys tem exposure scenario . A separate applicator assessment was not condu cted as the application of py rimethanil is mechanically automated for the in - line dip/drench wash tanks . A mixer/l oader assessment was performed and is considered to result in a conservative estimate of handler risk. Occupational Handler Exposure Data and Assumptions : A series of assumptions and exposure factors served as the basis for completing the occupational handler risk assessments. Each assumption and factor is detailed below on an individual basis. Application Rate : The application rate is the maximum rate identified on the proposed Penbotec ® 400SC label (See Section 4.0). Unit Exposures: It is the policy of HED to use the best available data to assess handler exposure. Sources of generic handler data, used as surrogate data in the absence of chemical - specific data, includ e PHED 1.1, the AHETF database , or other registrant - submitted occupational exp osure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The standard values recommended for use in predicting handler exposure that are used in this assessment, known as “unit exposure s”, are outlined in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table 2 ”, which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at the Agency website 3

. Amount Handled: Information on amount of fruit treated per day was taken from HED ExpoSAC Policy

/Guidance “ Assessment of Occupational Exposure for Post - Harvest Commodity Pesticide Treatments” (M. Crowley , 23 - MAR - 2012). Since the label specifies the application rate as a % solution and does not provide information on the amount of commodity to be treated, a default estimate of 25,000 gallons was used . Exposure Duration : HED classifies exposures from 1 to 30 day s as sh ort - term and exposures 30 day s to six months as intermediate - term. Exposure duration is determined by many things, including the exposed population, the use site, the pest pressure triggering the use of the pesticide, and the cultural practices surrounding that use site. For most agricultural uses, it is reasonable to believe that occupational handlers will not apply the same chemical every day for more than a one - month time frame; however, there may be a large agribusiness and/or commercial applicators who may appl y a product over a period of weeks (e.g., completing multiple applications for multiple clients within a region). For py rimethanil, based on the proposed use pattern , short - and intermediate - term exposures are expected. Inaddition, the 2 Available: http://www.epa.gov/opp00001/science/handler - exposure - table.pdf 3 Available: http://www.epa.gov/pesticides/science/handler - exposure - data.htmlPage 7 of 10

short - and intermediate - term PODs are the same; therefore, estimates for short - term durations are protective of longer- term exposure durations. Mitigation/Personal Protective Equipment: Estimates of dermal and inhalation exposure were calculated for various levels of PPE . Results are presented for “baseline,” defined as a single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no protective gloves, and no respirator, as well as baseline with various levels of PPE as necessary (e.g., gloves, respirator, etc). The py rimethanil product labels direct mixers, loaders, applicators and other handlers to wear long - sleeved shirt, long pants , shoes plus socks and chemical - resistant gloves. Occupational Handler Non - Cancer Exposure and Risk Estimate Equations : The algorithms used to estimate non - cancer exposure and dose for occupational handlers can be found in Appendix A . Combining Exposures/Risk Estimates : Dermal and inhalation risk estimates were combined in this assessment, since the toxicological effects for these exposure routes were similar. Dermal and inhalation risk estimates were combined using the following formula: Total MOE = Point of Departure (mg/kg/day) ÷ Combined dermal + inhalation dose (mg/kg/day) Summary of Occupational Handler Non - Cancer Exposure and Risk Estimates : Table 6.1.1 provides a summary

of the estimated exposures and risks to occupational pesticide handlers. An MOE ≥ 100 is adequate to protect occupational pesticide handlers from dermal and inhalation exposure . D ermal and inhalation risks for occupational handlers are above the L OC (100) with label - required PPE ( i.e., wear long - sleeved shirt, long pants, shoes plus socks and chemical re sistant gloves ) . **Table 6.1.1. Occupational Handler Non -**  **Cancer Exposure and Risk Estimates for Post -**  **harvest Use on Pomegranates** . **Exposure Scenario**  **Crop LOC**  **Dermal Unit**  **Exposure (μg/lb ai)**  **1 Inhalation** 

**Unit Exposure**  **(μg/lb ai) 1**  **Ma x.** 

**App. Rate**  **(lb ai/gal solution)**  **2 Am**  **ount**

**Handled Daily**  **(gal/day) 3**  **Dermal Inhalation**  **Total Mitigation**  **Level Mitigation** 

**Level Dose**  **(m g/k** **g/day) 4**  **MOE 5**  **Dose (m** **g/k g/day)**  **6 MOE**  **7 MOE**  **8** Mixer/Loader Open Mixing/ Loading Liquids for Automated System Pomegranates 100 Baseline: 220 PPE - G: 37.6 Baseline:

0.219 0.0082 25,000 Baseline: 0.289 PPE - G : 0.0494 Baseline:

80 PPE - G : 470 Baseline: 0.000565 Baseline :

41,000 Baseline:

80 PPE - G : 460 1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” ( May 2013 ); Level of mitigation: Baseline = Long sleeved shirt, long pants, shoes plus socks and no gloves (dermal); no respirator (inhalation). PPE - G = Long - sleeved shirt, long pants, shoes plus socks and chemical resistant gloves. 2 Based on registered or proposed label (Reg. No. 43813 - 32). 3 HED ExpoSAC Policy/Guidance “Assessment of Occupational Exposure for Post - Harvest Commodity Pesticide Treatments.” 4 Dermal Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/ μg) × Appli cation Rate (lb ai/gal) × Amount Handled (gal/day) × DAF ( 51 %) ÷ BW (80 kg). 5 Dermal MOE = Dermal NOAEL ( 23.1 mg/kg/day) ÷ Dermal Dose (mg/kg/day). 6 Inhalation Dose = I

nhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/ μg) × Application Rate (lb ai/gal) × Amount Handled (gal/day) ÷ BW (80 kg). 7 Inhalation MOE = I

nhalation NOAEL ( 23.1 mg/kg/day) ÷ I nhalation Dose (mg/kg/day). 8 Total MOE = NOAEL ( 23.1 mg/kg/day) ÷ Dermal Dose + I nhalation Dose.Page 8 of 10

**6 .**  **2 Occupational**  **Post -**  **application Exposure/** **Risk Estimates**  During automated treatments, dermal and inhalation exposure is anticipated for workers performing sorting and packing tasks. Since the workers experience exposure following the treatment, this is technically “post - application” exposure; however, unlike other post - application activities (e.g., harvesting, scouting, etc.), this treatment is not governed by the Worker Protection Standard (WPS) and p otential re - entry intervals (REIs). Additionally , for workers in the warehouse or packaging facility not directly

involved in the automated treatment process, there is potential for indirect inhalation exposure. Exposures for these various scenari os are assessed using HED ExpoSAC Policy /Guidance “ Assessment of Occupational Exposure for Post - Harvest Commodity Pesticide Treatments ” (M. Crowley , 23 - MAR - 2012). Occupational Post - application Exposure Data and Assumptions : A series of assumptions and exposure factors served as the basis for completing the occupational post - application risk assessments. Each assumption and factor is detailed below on an individual basis. Exposure Duration: HED classifies exposures from 1 to 30 day s as short - term and exposures 30 day s to six months as intermediate - term. For py rimethanil, based on the proposed use pattern, short - and intermediate - term exposures are expected. In addition, the short - and intermediate term PODs are the same; therefore, estimates for short - term durations are protective of longer term exposure durations. Application Rate: The application rate is the maximum rate identified on the proposed Penbotec ® 400SC label (See Section 4.0). Exposure Time : The average occupational workday is assumed to be 8 hours. Occupational Post - application Non - Cancer Exposure and Risk Estimate Equations : The algorithms used to estimate non - cancer exposure and dose for occupational post - application workers can be found in Appendix A . Combining Exposures/Risk Estimates : Dermal and inhalation risk estimates were combined in this assessment, since the toxicological effects for these exposure routes were similar. Dermal and inhalation risk estimates were combined using the following formula: Total MOE = Point of Departure (mg/kg/day) ÷ Combined dermal + inhalation dose (mg/kg/day) Occupational Post - application Non - Cancer Risk Estimates : The short - and intermediate - term risk estimates are not of concern (i.e., MOEs ≥100) at baseline ( i.e., t - shirt and no gloves and no respirator) for all post - application exposure activities. **Table 6.2.1. Occupational Post -**  **application Non -**  **Cancer Exposure and Risk Estimates for Pyrimethanil.**  **Crop/Site Activities**  **Ma x App.**  **Rate (%**  **ai in solution)**  **Dermal Inhalation**  **Combined**

**Unit Exposure**  **(μg/% ai)**  **1 Dose** 

**(m g/k** **g/day) 2**  **MOE 3**  **Unit Exposure**  **(μg/% ai)**  **1 Dose** 

**(m g/k** **g/day) 4**  **MOE 5**  **MOE 6** Page 9 of 10 **Mitigation Level**  **Mitigation Level**  Pomegranates Sorter 0.1 T - shirt/NG: 21,600 T - shirt/NG:

0.0139 1,700 NR 6,720 NR 0.0085 NR 2,700 T - shirt/NG and NR 1,000 Packer T - shirt/NG: 15,300 T - shirt/NG:

0.0098 2,400 NR 6,760 NR 0.0085 NR 2.700 T - shirt/NG and NR 1,300 1. Based on Table 2 in ExpoSAC Policy/Guidance “Assessment of Occupational Exposure for Post - Harvest Commodity Pesticide Treatments” (M. Crowley, 23 - MAR - 2012); Level of mitigation: T - shirt/NG = t - shirt and no gloves; NR = no respirator. 2. Dermal Dose = [Unit Exposure (μg/ % ai) * Application Rate (% ai in solution) * Adjustment Factor (0.001 μ g/mg)] ÷ Body W eight (80 kg). 3. Dermal MOE = Dermal POD (23.1 mg/kg/day)/Dermal Dose. 4. I nhalation Dose = [Unit E xposure (μg/% ai) * A pplication Rate (% ai in solution) * Adjustment F actor (0.001 μg/mg)] ÷ B ody W eight (80 kg). 5. I nhalation MOE = I

nhalation POD (23.1 mg/kg/day)/I nhalation Dose. 6. Total MOE = NOAEL (23.1 mg/kg/day) ÷ (Dermal Dose + I nhalation Dose). **Table 6.2.2. Occupational Post -**  **application Non -**  **Cancer Indirect Inhalation Exposure and Risk Estimates for**  **Pyrim ethanil.**  **Crop/Site Ma** **x App. Rate**

**(% ai in solution)**  **Inhalation Unit Exposure (μg/%**  **ai) 1**  **Inhalation Dose (m** **g/k g/day)**  **2 MOE**  **3 Mitigation Level**  Pomegranates 0.1 NR 307 NR 0.0004 NR 60,000 1. Based on Table 4 in ExpoSAC Policy/Guidance “Assessment of Occupational Exposure for Post - Harvest Commodity Pesticide Treatments” (M. Crowley, 23 - MAR - 2012); Level of mitigation: NR = no respirator. 2 . Inhalation Dose = [Unit E xposure (μg/% ai) * A pplication Rate (% ai in solution) * Adjustment Factor (0.001 μg/mg)] ÷ Body Weight (80 kg)]. 3 . Inhalation MOE = I

nhalation POD (23.1 mg/kg/day)/I nhalation Dose.Page 10 of 10

**Appendix A. Summary of Occupational and Residential**  **Non -**  **cancer Algorithms**  Occupational Non - cancer Handler Algorithms : P otential daily exposures for occupational handlers mixing and loading the pesticide formulation into large bin or vats to produce a dilute solution are calculated using the following formulas: Dose (mg) = [UE (mg/lb ai) * AaiH (lb ai) * AF] ÷ BW (kg) Where: UE = unit exposure (expressed as amount of exposure per amount of active ingredient handled)

AaiH = amount of active ingredient handled BW = body weight AF = absorption factor (route - specific) MOE : Non - cancer risk estimates for each application handler scenario are calculated using a MOE , which is a ratio of the toxicological endpoint to the daily dose of concern. The dail y dermal and inhalation dose received b y occupational handlers are compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational handlers for each exposure route. All MOE values are calculated using the following formula: MOE= POD ADD Where: MOE = m argin of e xposure: value used by HED to represent risk estimates (unitless),

POD = p oint of d eparture (mg/kg/day) , and ADD = average daily dose absorbed in a given scenario (mg ai/kg/day) . Occupational Non - cancer Post - application Algorithms : The methodology to calculate p otential daily exposures for occupational workers performing sorting, culling and packing tasks as well as to calculate potential indirect inhalation exposure as follows:

Dose (μg) = [UE (μg/% ai) * AR (% ai in solution) * AF] ÷ BW (kg) Where: UE = unit exposure (expressed as amount of exposure per % active ingredient in solution)

AR = application rate AF = absorption factor (route - specific) BW = body weight M OE : Non - cancer risk estimates for each post application scenario are calculated using a MOE , which is a ratio of the toxicological endpoint to the daily dose of concern. The daily dermal and inhalation dose are compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational handlers for each exposure route. All MOE values are calculated using the following formula: MOE= POD ADD Where: MOE = margin of exposure: value used by HED to represent risk estimates (unitless),

POD = point of departure (mg/kg/day), and ADD = average daily dose absorbed in a given scenario (mg ai/kg/ day).