1 update on residential pesticide exposure assessment standard operating procedures (sops) dod pest...

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

DoD Pest Management WorkshopNaval Air Station, Jacksonville, FLFebruary 11, 2010

Aaron Niman, LTJG (USPHS)Office of Pesticide ProgramsEnvironmental Protection Agency

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Health Effects DivisionOffice of Pesticide Programs 22

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


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


Overview: Registration Process

Risk Management

Pesticide Registrant EPA Chemical Review Manager

Scientific Review/ Risk Assessment

Evaluate Human Toxicity

Human Exposure Assessment

Environmental Assessment



Risk Management

Submit product chemistrySubmit Test DataSubmit Labeling InformationUse DirectionsOccupational Exposure DataWarnings

Review ApplicationCoordinate reviewLiaison with registrant

Evaluate human toxicityAssess human exposureOccupationalResidentialDietaryEvaluate enviro. riskCharacterize risk

Consider risk assessment findingsEvaluate labelReview risk mitigation options and alternativesRisk management regarding registrant application


Overview: Exposure Assessment

Exposure Assessment

Review Label

Identify Exposure Pathways

Quantify Exposure

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

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

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


Overview: Registration Process

Risk Management








Risk Management

Submit product chemistrySubmit Test DataSubmit Labeling InformationUse DirectionsOccupational DataWarnings



Consider risk assessment findingsReview risk mitigation options and alternativesRisk management regarding registrant application


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


Residential SOPs: Purpose

1. 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

2. Ensure that OPP exposure assessments are transparent to external stakeholders

3. Identify data gaps where additional data/research could improve future exposure assessments


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


Residential SOPs: Updates

Exposure Scenarios Lawns & Turf

Indoor Environments

Gardens & Trees

Treated Pets



Exposure Scenarios Outdoor Fogging/Misting Systems*

Impregnated Materials

Insect Repellents*

Paints/Wood Preservatives

* Not addressed in previous Residential SOP document.



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


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)



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



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)



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)


Residential SOPs: Updates Example EquationsPost-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 tt = time (e.g., m3/hr)

dttC(t)IRExposure

ET

'


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


Quantify Exposure


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

1. Product Formulation InformationPercent active ingredientFormulation Type

2. Use Directions

3. Warning and Use Restrictions



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


Quantify Exposure


Residential Handler Post-Application

Adults Children

Inhalation

Dermal

Dermal

Object-to-mouth

Hand-to-mouth

3. Exposure Routes

2. Exposed Groups

1. Exposure Scenario

Inhalation

Adults

Dermal

Inhalation

Granular Lawn Treatment



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


Quantify Exposure


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)


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 mouthedSAO = 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)


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 mouthedSAH = 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)


Registration Process

Risk Management








Risk Management

Submit product chemistrySubmit Test DataSubmit Labeling InformationUse DirectionsOccupational DataWarnings



Consider risk assessment findingsReview risk mitigation options and alternativesRisk management regarding registrant application


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


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


Questions

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