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

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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

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Outline

• Overview
• U.S. EPAs Office of Pesticide Programs (OPP)
• Registration Process
• Exposure Assessment
• Residential Exposure Assessment SOPs
• Scope
• Overview of Updates
• Example
• Future Directions

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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

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Overview Registration Process
Pesticide Registrant
EPA Chemical Review Manager
Scientific Review/ Risk Assessment
Evaluate Human Toxicity
Risk Management
Human Exposure Assessment
Environmental Assessment
Pesticide Registrant EPA Chemical Review Manager Scientific Review/ Risk Assessment Risk Management
Submit product chemistry Submit Test Data Submit Labeling Information Use Directions Occupational Exposure Data Warnings Review Application Coordinate review Liaison with registrant Evaluate human toxicity Assess human exposure Occupational Residential Dietary Evaluate enviro. risk Characterize risk Consider risk assessment findings Evaluate label Review risk mitigation options and alternatives Risk management regarding registrant application
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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
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Overview Registration Process
Pesticide Registrant
EPA Chemical Review Manager
Scientific Review/ Risk Assessment
Evaluate Human Toxicity
Risk Management
Human Exposure Assessment
Environmental Assessment
Pesticide Registrant EPA Chemical Review Manager Scientific Review/ Risk Assessment Risk Management
Submit product chemistry Submit Test Data Submit Labeling Information Use Directions Occupational Data Warnings Review Application Coordinate review Liaison with registrant Evaluate human toxicity Assess human exposure Occupational Residential Dietary Evaluate enviro. risk Characterize risk Consider risk assessment findings Review risk mitigation options and alternatives Risk management regarding registrant application
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Residential Exposure Assessment SOPs

• Residential SOPs
• Define most common residential exposure scenarios
  that are evaluated as part of OPPs 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

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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

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Residential SOPs Updates

• Draft Updated Residential SOPs recently reviewed
  by EPAs 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

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Residential SOPs Updates

• Exposure Scenarios
• Lawns Turf
• Indoor Environments
• Gardens Trees
• Treated Pets

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Residential SOPs Updates

• Exposure Scenarios
• Outdoor Fogging/Misting Systems
• Impregnated Materials
• Insect Repellents
• Paints/Wood Preservatives

Not addressed in previous Residential SOP
document.
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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
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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)

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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

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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)
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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)
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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)
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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
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1. Product Formulation Information Percent active
ingredient Formulation Type
2. Use Directions
3. Warning and Use Restrictions
http//www.purdue.edu/envirosoft/housewaste/src/re
adpest.htm
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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
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1. Exposure Scenario
Granular Lawn Treatment
Residential Handler
Post-Application
2. Exposed Groups
Adults
Children
Adults
3. Exposure Routes
Inhalation
Dermal
Dermal
Dermal
Object-to-mouth
Inhalation
Hand-to-mouth
Inhalation
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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
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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)
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Object-to-mouth Exposure Exposure
((OR(FMSAO)) (ETN_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)
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Hand-to-mouth Exposure Exposure ((HR(FMSAH))
(ETN_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)
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Registration Process
Pesticide Registrant
EPA Chemical Review Manager
Scientific Review/ Risk Assessment
Evaluate Human Toxicity
Risk Management
Human Exposure Assessment
Environmental Assessment
Pesticide Registrant EPA Chemical Review Manager Scientific Review/ Risk Assessment Risk Management
Submit product chemistry Submit Test Data Submit Labeling Information Use Directions Occupational Data Warnings Review Application Coordinate review Liaison with registrant Evaluate human toxicity Assess human exposure Occupational Residential Dietary Evaluate enviro. risk Characterize risk Consider risk assessment findings Review risk mitigation options and alternatives Risk management regarding registrant application
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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

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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/re
  g_review_process.htm
• Purdue Pesticide Programs Publications
• Pesticides and the Label
• http//www.btny.purdue.edu/Pubs/PPP/PPP-24/ppp24.h
  tml
• Pesticides and Human Health Risk Assessment
• http//www.btny.purdue.edu/Pubs/PPP/PPP-48.pdf

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Questions