# Presentation: 075175

## AHETF Protocol Reviews

**AHETF Protocol Reviews**

**June 2006**
**Human Studies Review Board Meeting**
_**Office of Pesticide Programs**_
_**Health Effects Division**_
- Jeff Dawson
- Jeff Evans

## Overview

***Perspective***
- Occupational Exposure Assessment Primer
- 5 AHETF Protocols For Review
- Results & Considerations From Science Reviews

## Perspective

- Limited exposure data
- Expensive (~$20,000 per person monitored)
- Early studies were quite varied and not used
- Need information on current practices & factors which impact exposures – AHETF formed
- A scenario-based, surrogate approach is used
- Many factors can impact exposures
- Systematic consideration of exposure patterns
- Cost effective, consensus building approach
- Data can be used to assess different chemicals with similar use/exposure patterns (surrogate exposure)

## Perspective

_**Goal For AHETF Process:**_
-   To develop data, in an ethical manner, that will allow the Agency to better predict the occupational exposures of pesticide handlers reflective of current agricultural practices and monitoring techniques.

## Perspective

- Iterative, multi-year process around AHETF that addresses:
- Research plan
- Monitoring protocols & supporting information/data
- Data analysis & use
- Joint process with Health Canada, California Department of Pesticide Regulation, AHETF members, and others

## AHETF Protocols

- To create a new and to supplement an existing database of surrogate unit exposure values to reflect contemporary  handler exposure scenarios for use in Agency risk assessments (e.g. ground boom equipment capable of treating 200+ acres per day)
- Address differing levels of personal protection for each scenario which is important for labeling purposes
- Assess sensitivity of exposure rates to various parameters (e.g., acres treated or pounds active ingredient handled)

## AHETF Protocols

## AHETF Protocols

## Overview

- Perspective
***Occupational Exposure Assessment Primer***
- 5 AHETF Protocols For Review
- Results & Considerations From Science Reviews

## Primer - Approach

- Multi-faceted approach for exposure analysis
***Scenario-based, surrogate exposure data based on passive dosimetry measurements****
- 2 basics – pesticide handlers & farm labor (e.g., harvesters)
- Approach used for bulk of Agency assessments
- Other inputs such as epidemiology & population-based monitoring are considered when available
- [* Focus today is on 5 protocols that will generate scenario-specific, pesticide handler exposure data]

## Exposure scenarios are defined by the job function (e.g., application) & factors including:
Equipment (e.g., groundboom, aircraft, etc.)
Physical nature of product (e.g., liquid, powder, etc.)
Packaging (e.g., open bottle, open bag, closed systems)
Vehicle type (e.g., tractor with no cab or a cab, etc.)
Clothing & protective gear worn (e.g., long pants, long-sleeved shirts, gloves, coveralls, respirator, etc.)
Key Factor: Handler exposures are proportional to amount of pesticide used, not identity of the pesticide ingredient (i.e., surrogate exposure)

- Equipment (e.g., groundboom, aircraft, etc.)
- Physical nature of product (e.g., liquid, powder, etc.)
- Packaging (e.g., open bottle, open bag, closed systems)
- Vehicle type (e.g., tractor with no cab or a cab, etc.)
- Clothing & protective gear worn (e.g., long pants, long-sleeved shirts, gloves, coveralls, respirator, etc.)
- Key Factor: Handler exposures are proportional to amount of pesticide used, not identity of the pesticide ingredient (i.e., surrogate exposure)

*Primer - Scenarios*

## Primer - Scenarios

*Primer - Scenarios*

## Primer - Scenarios

*Primer - Scenarios*

## Primer - Scenarios

*Primer - Scenarios*

## Primer - Scenarios

*Primer - Scenarios*

- Open cab airblast application to apples

## Primer - Scenarios

*Primer - Scenarios*

## Primer - Scenarios

*Primer - Scenarios*

## Primer - Scenarios

*Primer - Scenarios*

## Primer - Inputs

- Basic inputs for calculating scenario-based occupational handler exposures include:
- Application rate (e.g., lbs active ingredient/acre)
- Area treated in a day (e.g., acres)
***Unit exposure ***(i.e., how much gets on a person for each pound of active ingredient they handle)*

## Primer - Equations

- Daily Exposure =
- Acres/Day * Appl. Rate (lb ai/A) * ***Unit Expo. (mg/lb ai)***

- Margin of Exposure =  NOAEL/Daily Exposure

- Note:  *Unit exposure* estimates are to be obtained from proposed
- AHETF studies

## Primer – Guidelines

**EPA’s 40 CFR 26 Protection of Human Subjects****www.epa.gov/oppfead1/guidance/human-test.htm http://**
**U.S. Environmental Protection Agency, Occupational and Residential Exposure Test Guidelines, Series 875.1000 through 875.1600.  (revised, 1996)****http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/875_Occupational_and_Residential_Exposure_Test_Guidelines/Series/**
**U.S. Environmental Protection Agency, Working Draft - Occupational and Residential Exposure Test Guidelines, Series 875 Group-B, Postapplication Exposure Monitoring**** ****Test Guidelines Version 5.4 (1998)****http://www.epa.gov/scipoly/sap/1998/march/contents.htm **
**Good Laboratory Practices (40CFR160)**
**Test guidelines have been peer reviewed through FIFRA Scientific Advisory Panel process**

## Primer – Dermal

**Upper Leg**
**Lower leg**

**Front & Back Of Torso**

**Upper & Lower Arms**

- Note:  A handwashing technique is also used for that component of exposure.

## Primer - Handrinse

## Primer – Dermal

*Primer – Dermal*

- Facewipe Technique

## Primer - Inhalation

- Personal Sampling Pump & Collector Worn In Breathing Zone

- Personal Sampling Pump Calibrator

## Primer – Key Elements

- Pre-field Phase
- Field Phase
- Analytical
- Quality Assurance
- Quality Control

## Primer – Key Elements

- Pre-field Phase
- Protocol development
- Institutional review board assessments & documentation
- Site selection
**Worker recruitment**
- Analytical validation
- Preparation for field operations

## Primer – Key Elements

- Field Phase
- Calibration of analytical and application equipment
- Dosimeter preparation
- Generation of quality control samples
- Documentation of worker activities
- Dosimeter collection
- Sample storage & chain-of-custody
- Worker health & safety (e.g., health care access)
- Worker withdrawal from study

## Primer – Key Elements

- Analytical
- Methods development
- Determination of limits of quantification & detection
- Field sample analysis
- Methods performance & recovery evaluations
- Data analysis & summary
- Application of recovery correction factors

## Primer – Key Elements

- Quality Assurance
- Established by GLPs under regulation (40CFR160)
- Independent “Quality Assurance Units”
- Inspections of all key study phases
- Reporting back of issues to study management (e.g., protocol deviations)
- Identified issues included in final reports to Agency

## Primer – Key Elements

- Quality Control
- Application equipment calibration
- Sampling equipment calibration
- Analytical aspects
- Validation & performance
- Field Recovery
- Storage & transport
- Concurrent laboratory with field samples
- Chain of custody

## Overview

- Perspective
- Occupational Exposure Assessment Primer
***5 AHETF Protocols For Review***
- Results & Considerations From Science Reviews

## AHETF Protocols

| Scenarios | Unit Exposure Estimates (mg/lb ai) |  |
| --- | --- | --- |
|  | Long Pants & Long-Sleeved Shirts With Gloves
 | Long Pants & Long-Sleeved Shirts
With Engineering Control |
| Airblast
Application | X | X |
| Aerial Application | Not Tested | X |
| Mixing/Loading Liquids | X | X |
| Mixing/Loading Solids | X | Not Tested |

- X = proposed AHETF studies

## AHETF Protocols

- Background Package Includes:
- Multi-year monitoring program
- Established SOPs & analytical elements
- Washington Institutional Review Board documents
- Science reviews
- Ethics review
- 5 Different protocols under review
- AHE 34, 36, 37, 38, 42

## AHETF Protocols

- AHE 34
- Primary Objective:  Closed loading of a liquid pesticide product (e.g., suction probe)
- Secondary Objective:  Application with various equipment
- Proposed Amount Handled: 25 to 925 lb a.i. using 2 to 7 tankloads & containers 2.5 to 55 gallons in volume
- Test Chemical: Malathion 8EC (8 lb ai/gallon)
- Total Number Proposed Replicates: 13

## AHETF Protocols

- AHE 36
- Primary Objective:  Airblast application with closed or open cabs on trellis crops in the western states (e.g., grapes)
- Secondary Objective:  Open or closed mixing/loading with a liquid pesticide product
- Proposed Amount Handled: 15 to 70 lb a.i. using 50 to 200 gallons/acre & applying 0.5 to 2 lb a.i./acre
- Test Chemical: Malathion 8EC (8 lb ai/gallon)
- Total Number Proposed Replicates: 13

## AHETF Protocols

- AHE 37
- Primary Objective:  Airblast application with closed or open cabs on trellis crops in the eastern states (e.g., grapes)
- Secondary Objective:  Open mixing/loading with a wettable powder pesticide product
- Proposed Amount Handled: 10 to 30 lb a.i. using 50 to 100 gallons/acre & applying 0.5 to 1 lb a.i./acre
- Test Chemical: Diazinon 50WP (50% by weight)
- Total Number Proposed Replicates: 13

## AHETF Protocols

- AHE 38
- Primary Objective:  Airblast application with closed cabs on orchard crops in the eastern states (e.g., citrus)
- Secondary Objective:  Open mixing/loading with a liquid pesticide product
- Proposed Amount Handled: 15 to 80 lb a.i. using 100 to 300 gallons/acre & applying 3 to 5 lb a.i./acre
- Test Chemical: Carbaryl-SevinXLR (4 lb ai/gallon)
- Total Number Proposed Replicates: 8*
- [* possible mixer/loader replicates not specified]

## AHETF Protocols

- AHE 42
- Primary Objective:  Aerial application with closed cockpit aircraft on field crops in the western states (e.g., potatoes/onions)
- Secondary Objective:  Open or closed mixing/loading with a liquid pesticide product
- Proposed Amount Handled: 1200 to 2000 lb a.i. using 5 to 10 gallons/acre & applying 1 to 1.5 lb a.i./acre
- Test Chemical: Chlorothalonil 720F (6 lb ai/gallon)
- Total Number Proposed Replicates: 10

## Overview

- Perspective
- Occupational Exposure Assessment Primer
- 5 AHETF Protocols For Review
***Results & Considerations From Science Reviews***

## Science Review

- Summary
- Scientifically acceptable if properly conducted
- Will address current agricultural practices and equipment
- Standardized monitoring methods – historically, non-standard methods have confounded analyses
- Good quality control & quality assurance elements
- Institutional review board review & approval

## Science Review

- Issues & considerations
- Final acceptance and use of data will depend on scientific review of study conduct and results
- Agency analysis may apply factors to correct for various issues identified in review
- e.g., recovery losses or incomplete handwashing
- Results will be considered in overall research plan for AHETF
- [Note:  The Agency will also conduct separate ethics review of each study after its completion]

## AHETF Charge to the HSRB

## AHETF Charge to the HSRB

## AHETF Charge to the HSRB

## AHETF Charge to the HSRB

## AHETF Charge to the HSRB

## Questions ?