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Update on Residential Pesticide Exposure Assessment Standard Operating Procedures (SOPs). DoD Pest Management Workshop Naval Air Station, Jacksonville, FL February 11, 2010 Aaron Niman, LTJG (USPHS) Office of Pesticide Programs Environmental Protection Agency. Outline. Overview

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update on residential pesticide exposure assessment standard operating procedures sops

Update on Residential Pesticide Exposure Assessment Standard Operating Procedures (SOPs)

DoD Pest Management Workshop

Naval Air Station, Jacksonville, FL

February 11, 2010

Aaron Niman, LTJG (USPHS)

Office of Pesticide Programs

Environmental Protection Agency

outline
Outline
  • Overview
    • U.S. EPA’s Office of Pesticide Programs (OPP)
    • Registration Process
    • Exposure Assessment
  • Residential Exposure Assessment SOPs
    • Scope
    • Overview of Updates
  • Example
  • Future Directions

Health Effects Division

Office of Pesticide Programs

overview opp
Overview: OPP
  • Principal Business
    • Protect human health and the environment
    • Realize the value from pesticide availability
  • Responsible for ensuring the safety of pesticides by conducting multi-pathway and multi-chemical exposure and risk assessments
    • Food
    • Water
    • Residential
    • Occupational
    • Environment

Health Effects Division

Office of Pesticide Programs

overview registration process
Overview: Registration Process

Pesticide Registrant

EPA Chemical Review Manager

Scientific Review/ Risk Assessment

Evaluate Human Toxicity

Risk Management

Human Exposure

Assessment

Environmental Assessment

Health Effects Division

Office of Pesticide Programs

overview exposure assessment
Overview: Exposure Assessment

Exposure Assessment

  • Identify applications (Occupational, residential, agricultural)
  • Determine use patterns (Application Rate, use frequency and location , PPE, etc.)

Review Label

  • Identify potentially exposed population (adults, children, infants)
  • Determined exposure pathways (inhalation, dermal, ingestion)

Identify Exposure Pathways

  • Select appropriate assumptions and data inputs
  • Characterize data gaps/ uncertainty

Quantify Exposure

Health Effects Division

Office of Pesticide Programs

overview registration process1
Overview: Registration Process

Pesticide Registrant

EPA Chemical Review Manager

Scientific Review/ Risk Assessment

Evaluate Human Toxicity

Risk Management

Human Exposure Assessment

Environmental Assessment

Health Effects Division

Office of Pesticide Programs

residential exposure assessment sops
Residential Exposure Assessment SOPs

Residential SOPs:

  • Define most common residential exposure scenarios that are evaluated as part of OPP’s risk assessment process
  • Define exposure equations that are used to quantify exposure
  • Define the data sources and assumptions that are used quantify exposure
  • Characterize uncertainty associated with SOPs

Health Effects Division

Office of Pesticide Programs

residential sops purpose
Residential SOPs: Purpose
  • Provide OPP Risk Assessors with guidelines to assess residential pesticide exposure

Guidance on how to:

      • Assess exposure without chemical-specific data
      • Identify appropriate exposure pathways and routes of exposure
      • Identify appropriate population groups of concern
  • Ensure that OPP exposure assessments are transparent to external stakeholders
  • Identify data gaps where additional data/research could improve future exposure assessments

Health Effects Division

Office of Pesticide Programs

residential sops updates
Residential SOPs: Updates
  • Draft Updated Residential SOPs recently reviewed by EPA’s Scientific Advisory Panel (10/2009)
    • Available at www.regulations.gov. Search: “EPA-HQ-OPP-2009-0516”.
  • Incorporate latest scientific data/research
    • Peer-reviewed literature
    • Propriety data submitted as part of registration process
    • New exposure equations and models
    • More advanced assessment capabilities (e.g. probabilistic methods)
  • Incorporate exposure scenarios that were previously assessed but not formally documented
    • Misting systems
    • Repellents

Health Effects Division

Office of Pesticide Programs

residential sops updates1
Residential SOPs: Updates
  • Exposure Scenarios
    • Lawns & Turf
    • Indoor Environments
    • Gardens & Trees
    • Treated Pets

Health Effects Division

Office of Pesticide Programs

residential sops updates2
Residential SOPs: Updates
  • Exposure Scenarios
    • Outdoor Fogging/Misting Systems*
    • Impregnated Materials
    • Insect Repellents*
    • Paints/Wood Preservatives

* Not addressed in previous Residential SOP document.

Health Effects Division

Office of Pesticide Programs

residential sops updates3
Residential SOPs: Updates
  • Potentially Exposed Populations
    • Select age categories based on factors influencing exposure
    • Adults and Children (Teens, Youths, Toddlers, Infants)

http://www.btny.purdue.edu/Pubs/PPP/PPP-48.pdf

Health Effects Division

Office of Pesticide Programs

residential sops updates4
Residential SOPs: Updates
  • Routes of Exposure
    • Residential Handler (during application)
      • Dermal Contact
      • Inhalation
    • Residential Post-application
      • Dermal Contact
      • Inhalation
      • Non-Dietary Ingestion (i.e. child object-to-mouth and hand-to-mouth behavior)

Health Effects Division

Office of Pesticide Programs

residential sops updates5
Residential SOPs: Updates
  • Exposure Equations
    • Quantify potential exposure from specific routes and scenarios
      • Based on combination of monitoring/observational data and mechanistic models
    • Equation inputs based on best available data sources
      • Industry workgroups/ registrant studies
      • Peer-reviewed literature
      • EPA guidance documents

Health Effects Division

Office of Pesticide Programs

residential sops updates6
Residential SOPs: Updates
  • Example Equations

Dermal and Inhalation Handler Exposure

Exposure during the mixing/loading and application of pesticides. Examples include applications of granule applications to lawns using a push-type spreader and applications of liquids to gardens using a hand-held pump sprayer.

All residential handler scenarios

Exposure = UE * AaiH

Where:

UE = Unit Exposure (e.g., mg ai/lb ai)

AaiH = Amount active ingredient handled (e.g., lb ai)

Health Effects Division

Office of Pesticide Programs

residential sops updates7
Residential SOPs: Updates
  • Example Equations

Post-application Dermal Exposure

Dermal exposure following pesticide applications as a result of contacting treated surfaces (e.g., playing on lawns or carpets) or as a result of direct deposition (e.g., insect repellents).

Lawns/turf, gardens, trees, pets, and indoor surfaces

Exposure = TC * CR * ET

Where:

TC = Transfer Coefficient (e.g., cm2/hr)

CR = chemical residue available for surface-to-skin transfer (e.g., mg/cm2)

ET = exposure time (e.g., hr)

Health Effects Division

Office of Pesticide Programs

residential sops updates8
Residential SOPs: Updates
  • Example Equations

Post-application Inhalation Exposure

Inhalation exposure following indoor/outdoor space sprays or via chemical volatilization from surfaces. Examples include outdoor foggers, misting systems in yards or barns, indoor total release aerosols, candles/coils/torches/mats, and indoor surface spray volatilization.

Where:

IR = inhalation rate (e.g., m3/hr)

ET = exposure time (e.g., hrs)

C(t) = Concentration at time t

t = time (e.g., m3/hr)

Health Effects Division

Office of Pesticide Programs

residential exposure assessment example
Residential Exposure Assessment: Example
  • Review Label
    • Determine concentration of active ingredient
    • Determine product formulations
    • Identify application methods
    • Identify potential uses
    • Identify use restrictions

Review Label

Identify Exposure Pathways

Quantify Exposure

Health Effects Division

Office of Pesticide Programs

slide19

1. Product Formulation Information

    • Percent active ingredient
    • Formulation Type

2. Use Directions

3. Warning and Use Restrictions

http://www.purdue.edu/envirosoft/housewaste/src/readpest.htm

Health Effects Division

Office of Pesticide Programs

residential exposure assessment example1
Residential Exposure Assessment: Example
  • Identify Exposure Pathways
    • Link labeled uses to exposure scenarios
    • Consult Residential Exposure Assessment SOP guidelines on exposure scenarios
      • Exposure pathways
      • Duration of exposure
        • Acute
        • Short-term
        • Chronic
      • Potentially exposed age groups

Review Label

Identify Exposure Pathways

Quantify Exposure

Health Effects Division

Office of Pesticide Programs

slide21

1. Exposure Scenario

Granular Lawn Treatment

Residential Handler

Post-Application

2. Exposed Groups

Adults

Adults

Children

3. Exposure Routes

Inhalation

Dermal

Dermal

Dermal

Inhalation

Object-to-mouth

Hand-to-mouth

Inhalation

Health Effects Division

Office of Pesticide Programs

residential exposure assessment example2
Residential Exposure Assessment: Example
  • Quantify Exposure
    • Consult Residential Exposure Assessment SOP guidelines on exposure scenarios
      • Exposure equations
        • Residential Handler
        • Dermal
        • Inhalation
        • Ingestion
      • Assumptions and data inputs
        • Age-specific inputs
        • Scenario-specific inputs
      • Characterize Uncertainty

Review Label

Identify Exposure Pathways

Quantify Exposure

Health Effects Division

Office of Pesticide Programs

slide23

Post-application Dermal Exposure

Exposure = TC * CR * ET

Where:

TC = Transfer Coefficient (e.g., cm2/hr)

CR = chemical residue available for surface-to-skin transfer (e.g., mg/cm2)

ET = exposure time (e.g., hrs)

Health Effects Division

Office of Pesticide Programs

slide24

Object-to-mouth Exposure

Exposure = ((OR*(FM*SAO)) * (ET*N_Replen) *

(1- (1-SE)(Freq_O-to-M/N_Replen))

Where:

OR = object residue loading (e.g., mg ai/cm2)

FM = fraction of object mouthed

SAO = surface area of object (e.g., cm2)

ET = exposure time (e.g., hrs)

N_Replen = object loading replenishments (e.g., # / hr)

Freq_O-to-M = object-to-mouth contact frequency (e.g., # / hr)

SE = saliva extraction (fraction)

Health Effects Division

Office of Pesticide Programs

slide25

Hand-to-mouth Exposure

Exposure = ((HR*(FM*SAH)) * (ET*N_Replen) *

(1- (1-SE)(Freq_H-to-M/N_Replen))

Where:

HR = hand residue loading (e.g., mg ai/cm2)

FM = fraction of hand mouthed

SAH = surface area of hand (e.g., cm2)

ET = exposure time (e.g., hrs)

N_Replen = hand loading replenishments (e.g., # / hr)

Freq_H-to-M = hand-to-mouth contact frequency (e.g., # / hr)

SE = saliva extraction (fraction)

Health Effects Division

Office of Pesticide Programs

registration process
Registration Process

Pesticide Registrant

EPA Chemical Review Manager

Scientific Review/ Risk Assessment

Evaluate Human Toxicity

Risk Management

Human Exposure

Assessment

Environmental Assessment

Health Effects Division

Office of Pesticide Programs

future directions
Future Directions
  • Incorporating peer-review comments from Scientific Advisory Panel and other stakeholders
  • Continue to revise SOPs as new data and information becomes available
  • Particularly interested in testing protocols that can help standardize data reporting

Health Effects Division

Office of Pesticide Programs

resources
Resources
  • Residential SOP Scientific Advisory Panel Peer-Review, Background Materials, and Public Comments
    • Available at www.regulations.gov. Search: “EPA-HQ-OPP-2009-0516”.
  • Overview on Pesticide Registration Review Process
    • http://www.epa.gov/oppsrrd1/registration_review/reg_review_process.htm
  • Purdue Pesticide Programs Publications
    • Pesticides and the Label
      • http://www.btny.purdue.edu/Pubs/PPP/PPP-24/ppp24.html
    • Pesticides and Human Health Risk Assessment
      • http://www.btny.purdue.edu/Pubs/PPP/PPP-48.pdf

Health Effects Division

Office of Pesticide Programs

questions
Questions

Health Effects Division

Office of Pesticide Programs