1. 1 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

2. Health Effects Division Office of Pesticide Programs 2 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

3. Health Effects Division Office of Pesticide Programs 3 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

4. Health Effects Division Office of Pesticide Programs 4 Overview: Registration Process Risk Management Pesticide Registrant EPA Chemical Review Manager Scientific Review/ Risk Assessment Evaluate Human Toxicity Human Exposure Assessment Environmental Assessment Pesticide RegistrantEPA 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

5. Health Effects Division Office of Pesticide Programs 5 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

6. Health Effects Division Office of Pesticide Programs 6 Overview: Registration Process Risk Management Pesticide Registrant EPA Chemical Review Manager Scientific Review/ Risk Assessment Evaluate Human Toxicity Human Exposure Assessment Environmental Assessment Pesticide RegistrantEPA 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

7. Health Effects Division Office of Pesticide Programs 7 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

8. Health Effects Division Office of Pesticide Programs 8 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

9. Health Effects Division Office of Pesticide Programs 9 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

10. Health Effects Division Office of Pesticide Programs 10 Residential SOPs: Updates  Exposure Scenarios  Lawns & Turf  Indoor Environments  Gardens & Trees  Treated Pets

11. Health Effects Division Office of Pesticide Programs 11 Residential SOPs: Updates  Exposure Scenarios  Outdoor Fogging/Misting Systems*  Impregnated Materials  Insect Repellents*  Paints/Wood Preservatives * Not addressed in previous Residential SOP document.

12. Health Effects Division Office of Pesticide Programs 12 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

13. Health Effects Division Office of Pesticide Programs 13 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)

14. Health Effects Division Office of Pesticide Programs 14 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

15. Health Effects Division Office of Pesticide Programs 15 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)

16. Health Effects Division Office of Pesticide Programs 16 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., cm 2 /hr) CR = chemical residue available for surface-to-skin transfer (e.g., mg/cm 2 ) ET = exposure time (e.g., hr)

17. Health Effects Division Office of Pesticide Programs 17 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., m 3 /hr) ET = exposure time (e.g., hrs) C(t) = Concentration at time t t = time (e.g., m 3 /hr)

18. Health Effects Division Office of Pesticide Programs 18 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

19. Health Effects Division Office of Pesticide Programs 19 http://www.purdue.edu/envirosoft/housewaste/src/readpest.htm 1. Product Formulation Information Percent active ingredient Formulation Type 2. Use Directions 3. Warning and Use Restrictions

20. Health Effects Division Office of Pesticide Programs 20 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

21. Health Effects Division Office of Pesticide Programs 21 Residential HandlerPost-Application AdultsChildren Inhalation Dermal Object-to- mouth Hand-to- mouth 3. Exposure Routes 2. Exposed Groups 1. Exposure Scenario Inhalation Adults Dermal Inhalation Granular Lawn Treatment

22. Health Effects Division Office of Pesticide Programs 22 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

23. Health Effects Division Office of Pesticide Programs 23 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)

24. Health Effects Division Office of Pesticide Programs 24 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/cm 2 ) FM = fraction of object mouthed SAO = surface area of object (e.g., cm 2 ) 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)

25. Health Effects Division Office of Pesticide Programs 25 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/cm 2 ) FM = fraction of hand mouthed SAH = surface area of hand (e.g., cm 2 ) 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)

26. Health Effects Division Office of Pesticide Programs 26 Registration Process Risk Management Pesticide Registrant EPA Chemical Review Manager Scientific Review/ Risk Assessment Evaluate Human Toxicity Human Exposure Assessment Environmental Assessment Pesticide RegistrantEPA 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

27. Health Effects Division Office of Pesticide Programs 27 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

28. Health Effects Division Office of Pesticide Programs 28 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_proce ss.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

29. Health Effects Division Office of Pesticide Programs 29 Questions