                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, 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:  D417166
Decision No.:  484376
Registration No.:  43813-32
Petition No.:  3F8213
Regulatory Action:  Section 3
Risk Assessment Type: Occupational/Residential Exposure Assessment
Case No.: 7059
TXR 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 Lowe, 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; 7505P)
			
Introduction		

RD has requested that HED conduct an exposure and risk assessment for the post-harvest use of pyrimethanil 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) database; 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.
                               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	10

1.0	Executive Summary

This document presents an occupational and residential exposure/risk assessment for the proposed post-harvest application of pyrimethanil to pomegranates.  There are currently no registered or proposed residential uses for pyrimethanil. 

Use Summary:  Pyrimethanil is currently registered as an anilinopyrimidine fungicide that inhibits the secretion of fungal enzymes which are required during the infection process.  The petition submitted by the registrant includes adding pomegranates to the Penbotec[(R)] 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 body weights and body weight gains.  A dermal absorption factor of 51% was used for the exposure assessment.  No inhalation 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 doses.  A margin of exposure (MOE) of 100 does not exceed the Agency's level of concern (LOC).  Pyrimethanil has been reclassified as "Not Likely to be Carcinogenic at doses that do not pertubate thyroid hormone stimulation."

Occupational Handler Exposure/Risk:  Based on the proposed use, it is anticipated that there will be occupational handler short- and intermediate-term dermal and inhalation exposures.  Chronic exposure is not expected for the proposed uses.  Dermal and inhalation risk estimates 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 baseline (i.e., t-shirt and no gloves and no respirator) for all post-application exposure activities.

Residential Exposure/Risk:  Currently, there are no registered/proposed uses of pyrimethanil 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 studies 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 with applicable ethics requirements.  For certain studies, the ethics review may have included 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.  

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 pyrimethanil.  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 pyrimethanil.  Pyrimethanil 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.  Acute Toxicity Profile  -  Pyrimethanil.
                           Guideline No./Study Type
                                   MRID No.
                                    Results
                               Toxicity Category
                         870.1100/Acute oral toxicity
                                   43345002
                      LD50 = 4149 mg/kg, M 5971 mg/kg, F
                                      III
                        870.1200/Acute dermal toxicity
                                   43345003
                              LD50 >5000 mg/kg
                                      IV
                      870.1300/Acute inhalation toxicity
                                   43301604
                              LC50 >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 pyrimethanil.  However, the HED HASPOC looked at all existing hazard and exposure data, and current use patterns for pyrimethanil, and used a weight-of-evidence (WOE) approach to conclude that subchronic inhalation toxicity study is not required for pyrimethanil 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 does not exceed the Agency's LOC.  Pyrimethanil has been reclassified as "Not Likely to be Carcinogenic at doses that do not pertubate thyroid hormone stimulation."   
Table 3.0.2.  Summary of Toxicological Doses and Endpoints for Pyrimethanil 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, inhalation)
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 patterns.  Penbotec[(R)] 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 applicators and other handlers to wear PPE which consists 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 Timing, Type, Equipment
                               Application Rate
                                (lb ai/100 gal)
                       Maximum Seasonal Application Rate
                                (lb ai/100 gal)
                                    PHI[1]
                                    (days)
                                    RTI[2]
                                    (days)
                                  Min. GPA[3]
Pomegranates
                        Penbotec[(R)] 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 pyrimethanil that result in residential exposures.  Therefore, a quantitative residential exposure assessment 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 to applications and exposures can vary depending on the specifics of each task.  Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used by 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, types 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 mixing/loading liquids for automated system exposure scenario.  A separate applicator assessment was not conducted as the application of pyrimethanil is mechanically automated for the in-line dip/drench wash tanks.  A mixer/loader 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[(R)] 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, include PHED 1.1, the AHETF database, or other registrant-submitted occupational exposure 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 exposures", are outlined in the "Occupational Pesticide Handler Unit Exposure Surrogate Reference Table", 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. 

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 days as short-term and exposures 30 days 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 apply a product over a period of weeks (e.g., completing multiple applications for multiple clients within a region).  For pyrimethanil, 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.

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 pyrimethanil 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.  Dermal and inhalation risks for occupational handlers are above the LOC (100) with label-required PPE (i.e., wear long-sleeved shirt, long pants, shoes plus socks and chemical resistant 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]
                    Max. App. Rate (lb ai/gal solution)[2]
                       Amount Handled Daily (gal/day)[3]
                                    Dermal
                                  Inhalation
                                     Total
                                       
                                       
                                       
                               Mitigation Level
                               Mitigation Level
                                       
                                       
                              Dose (mg/kg/day)[4]
                                    MOE[5]
                              Dose (mg/kg/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) x Conversion Factor (0.001 mg/μg) x Application Rate (lb ai/gal) x Amount Handled (gal/day) x DAF (51%) / BW (80 kg).
5	Dermal MOE = Dermal NOAEL (23.1 mg/kg/day) / Dermal Dose (mg/kg/day).
6	Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) x Conversion Factor (0.001 mg/μg) x Application Rate (lb ai/gal) x Amount Handled (gal/day) / BW (80 kg).
7	Inhalation MOE = Inhalation NOAEL (23.1 mg/kg/day) / Inhalation Dose (mg/kg/day).
8	Total MOE = NOAEL (23.1 mg/kg/day) / Dermal Dose + Inhalation Dose.
  

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 potential 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 scenarios 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 days as short-term and exposures 30 days to six months as intermediate-term.  For pyrimethanil, 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[(R)] 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
                                 Max App. Rate
                              (% ai in solution)
                                    Dermal
                                  Inhalation
                                   Combined 
                                       
                                       
                                       
                          Unit Exposure (μg/% ai)[1]
                                     Dose
                                (mg/kg/day)[2]
                                    MOE[3]
                          Unit Exposure (μg/% ai)[1]
                                     Dose
                                (mg/kg/day)[4]
                                    MOE[5]
                                    MOE[6]
                                       
                                       
                                       
                               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 (ug/% ai) * Application Rate (% ai in solution) * Adjustment Factor (0.001 μg/mg)] / Body Weight (80 kg).
3.  Dermal MOE = Dermal POD (23.1 mg/kg/day)/Dermal Dose.
4.  Inhalation Dose = [Unit Exposure (ug/% ai) * Application Rate (% ai in solution) * Adjustment Factor (0.001 μg/mg)] / Body Weight (80 kg).
5.  Inhalation MOE = Inhalation POD (23.1 mg/kg/day)/Inhalation Dose.
6.  Total MOE = NOAEL (23.1 mg/kg/day) / (Dermal Dose + Inhalation Dose).

Table 6.2.2.  Occupational Post-application Non-Cancer Indirect Inhalation Exposure and Risk Estimates for Pyrimethanil.
                                   Crop/Site
                                 Max App. Rate
                              (% ai in solution)
                                  Inhalation
                                       
                                       
                          Unit Exposure (μg/% ai)[1]
                                Inhalation Dose
                                (mg/kg/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 Exposure (ug/% ai) * Application Rate (% ai in solution) * Adjustment Factor (0.001 μg/mg)] / Body Weight (80 kg)].
3.  Inhalation MOE = Inhalation POD (23.1 mg/kg/day)/Inhalation Dose.

Appendix A.  Summary of Occupational and Residential Non-cancer Algorithms

Occupational Non-cancer Handler Algorithms:  Potential 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 daily dermal and inhalation dose received by 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= PODADD

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).

Occupational Non-cancer Post-application Algorithms:  The methodology to calculate potential daily exposures for occupational workers performing sorting, culling and packing tasks as well as to calculate potential indirect inhalation exposure as follows: 

     Dose (ug) = [UE (ug/% 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

MOE:  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= PODADD

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).
