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.
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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
Page 3 of 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®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 
Page 4 of 10

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 website1. 

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 weightof-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." 

 

1

http://www.epa.gov/pesticides/science/handler-exposure-data.html and 

http://www.epa.gov/pesticides/science/post-app-exposure-data.html
Page 5 of 10

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®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)

PHI1

(days)

RTI2

(days)

Min. 

GPA3

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 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 
Page 6 of 10

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®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 Table2”, 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 website3.

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 

 

2 Available: http://www.epa.gov/opp00001/science/handler-exposure-table.pdf

3 Available: http://www.epa.gov/pesticides/science/handler-exposure-data.html
Page 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 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 MOE5 Dose (mg/kg/day)6 MOE7 MOE8

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 = Longsleeved 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) × Application 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 = Inhalation 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 = 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.

 
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 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 intermediateterm PODs are the same; therefore, estimates for short-term durations are protective of longerterm 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

Max App. 

Rate

(% ai in 

solution)

Dermal Inhalation Combined 

Unit 

Exposure 

(μg/% ai)1

Dose

(mg/kg/day)2 MOE3

Unit 

Exposure 

(μg/% ai)1

Dose

(mg/kg/day)4 MOE5 MOE6
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 μg/mg)] ÷ Body Weight (80 kg).

3. Dermal MOE = Dermal POD (23.1 mg/kg/day)/Dermal Dose.

4. Inhalation Dose = [Unit Exposure (μg/% 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 MOE3

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 (μg/% 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.
Page 10 of 10

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= 

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).

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 (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

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= 

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).