U.S. EPA: Occupational and Residential Exposure ORE Assessment

1. 1 U.S. EPA: Occupational and Residential Exposure (ORE) Assessment NCAEHA Spring 2010 Educational Conference Zaida Figueroa, M.S. U.S. EPA, Office of Pesticide Programs George Washington University, DrPH-EOH April 29, 2010

2. 2 Disclaimer Although this work is based on the U.S. EPA Office of Pesticide Programs initiatives, it may not necessarily reflect official Agency policy.

3. 3 Overview: Office of Pesticide Programs Principal Business Protect human health and the environment Ensure that society has access to pesticides and the associated benefits Responsible for ensuring the safety of pesticides by conducting multi-pathway and multi-chemical exposure and risk assessments: Food Water Residential Occupational Environmental Fate

4. 4 Constituents & Stakeholders Liaisons: You need to establish your constituents and stakeholders. In this particular example, for the Residential SOPs revision the players are:Liaisons: You need to establish your constituents and stakeholders. In this particular example, for the Residential SOPs revision the players are:

5. 5 Overview: Registration Process

6. 6 Overview: Registration Process

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9. 9 What is ORE? Risk assessment is the process of quantifying and characterizing the risk associated with hazardous substances, process, actions, or events

10. 10 What is ORE? Risk = Hazard / Exposure Risk - The likelihood of a specified adverse health effect Hazard � Identification/quantification of harmful effects after oral, dermal and/or inhalation exposure to a pesticide Exposure � Contact with a determined amount of pesticide or chemical agent

11. 11 What is ORE? ORE � Occupational and Residential Exposure Assessment Occupational Pesticide handlers and field workers (adults only) Handlers = workers mixing, loading applying pesticides Postapplication = workers conducting postapplication activities (e.g., tinning, scouting, hand harvesting) Residential Individuals potentially exposed to a pesticide in and around the home (adults and children) Handlers = homeowners mixing, loading applying pesticides (mostly RTU products) Postapplication = homeowners and children exposed to treated residential areas

12. 12 What is ORE? Exposure Routes Dermal � Adults and Children Inhalation � Adults and Children Incidental Oral (Hand-to-Mouth) � Children ORE does not consider food or drinking water source routes of exposure.

13. 13 What is ORE? Why is ORE important? To prevent worker and residential overexposures and potential adverse health effects. When all exposure scenarios are considered, workers often have the greatest dose potential Children are addressed specifically due to increased potential for risk from: Additional exposure route (incidental oral) Dose per body weight Increased susceptibility

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15. 15 Overview: Exposure Assessment

16. 16 Basic Concepts of ORE Assessment  1. Define the Exposure Scenario - Determine Application Method(s) - Determine Who is Exposed 2. Select Exposure Duration(s) (match with toxicity) 3. Quantify Exposure

17. 17 1. Define the Exposure Scenario Label = The legal document (all regulatory decisions delineated here). Crop(s) Treated Application Rate(s) Maximum for Acute and Short/Intermediate Term Restricted Entry Interval(s) (REIs) Handler Personal Protective Equipment (PPE)

18. 18 2. Select Exposure Duration(s)  (match with toxicity) Acute -1 day e.g., Fumigation Handlers Short Term - 1 to 30 days e.g., Private grower applying an early season herbicide Intermediate Term � 1 to 6 months e.g., Custom applicator applying an early season herbicide Long Term - > 6 months e.g., Greenhouse Workers

19. 19 3. Quantify Exposure Unit Exposure Concept (Determine Contact Factors) Unit Exposure Data and PHED/ORETF Handler � Unit Exposure Postapplication � Transfer Coefficient (TC) and Dislodgeable Foliar Residue (DFR) Handler/Postapplication Exposure and Dose Estimating Handler/Postapplication Risk Risk Characterization and Refinement Risk Mitigation Risk Management

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21. 21 Residential Exposure Topics Overview of Residential Exposure Residential Standard Operating Procedures (SOPs) General Aspects of Residential Handler and Post-Application Exposure Assessment Introducing individual SOP groups

22. 22 �Residential� Means Anything Non-Occupational

23. 23 Residential vs. Occupational Exposure Normal clothing worn Assumes short sleeves and shorts Handlers mix, load and apply Less pesticide used overall Smaller area treated Hand-held equipment

24. 24 Residential Exposure Information Sources Residential SOPs Labels Pesticide Handlers Exposure Database (PHED) Task Forces (e.g., ORETF, NDETF) Exposure Factors Handbook Chemical-specific studies

25. 25 Residential Exposure Assessment SOPs Defines most common residential exposure scenarios that are evaluated as part of OPP�s risk assessment process Defines exposure equations that are used to quantify exposure Defines the data sources and assumptions that are used quantify exposure Characterizes uncertainty associated with SOPs

26. 26 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 research would improve future exposure assessments

27. 27 Residential SOPs Time Line Food Quality Protection Act (FQPA) created in 1996 SOPs created in 1997 http://www.epa.gov/oscpmont/sap/1997/september/sopindex.htm Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Science Advisory Panel (SAP) in 1997 and 1999 Updated in 2001 (New Policies) New Update in Progress (2008-2010) Has been number of years since last update; looking for new data Historically SOPs have taken deterministic approach; moving towards probabilistic assessments How everything started? With the enactment of the Food Quality Protection Act (FQPA) of 1996, Congress presented EPA with the challenge of include strict safety standards, especially for infants and children, and complete aggregate exposures and reassess all the existing pesticide tolerances. The FQPA amended FIFRA and the Federal Food Drug, and Cosmetic Act (FFDCA) by fundamentally changing the way EPA regulates pesticides.How everything started? With the enactment of the Food Quality Protection Act (FQPA) of 1996, Congress presented EPA with the challenge of include strict safety standards, especially for infants and children, and complete aggregate exposures and reassess all the existing pesticide tolerances. The FQPA amended FIFRA and the Federal Food Drug, and Cosmetic Act (FFDCA) by fundamentally changing the way EPA regulates pesticides.

28. 28 Residential SOPs: Scope Assess residential exposure to non-biocide pesticides (e.g. insecticides, herbicides, fungicides) Routes of Exposure Residential Handler (during application) � Commercial Applicator and/or Homeowner Dermal Contact Inhalation Residential Post-application (Adults and children) Dermal Contact Inhalation Non-Dietary Ingestion (i.e. child object-to-mouth and hand-to-mouth behavior)

29. 29 Here are the scenarios covered by the Residential SOPs.Here are the scenarios covered by the Residential SOPs.

30. 30 Residential SOPs: Exposure Scenarios Lawns & Turf Indoor Environments Gardens & Trees Treated Pets

31. 31 Residential SOPs: Exposure Scenarios Outdoor Fogging/Misting Systems* Impregnated Materials Insect Repellents* Paints/Wood Preservatives

32. 32 Residential SOPs: Potentially Exposed Populations Select age categories based on factors influencing exposure Adults and Children (Teens, Youths, Toddlers, Infants)

33. 33 Why Update Residential SOPs? Current SOPs drafted in 1997 with subsequent amendments in 2001 Incorporate latest scientific findings Review of data and research Peer-reviewed literature Propriety data submitted as part of registration process New exposure equations and models Enable more advanced assessment capabilities (e.g. probabilistic methods) Incorporate exposure scenarios that are assessed but not formally documented Misting systems Repellents

34. 34 Residential Handler Exposure Routes of exposure � Dermal and Inhalation (adults only) Unit Exposures taken from various sources (e.g., PHED, ORETF, etc) Amount applied per day or the area treated will differ depending on the exposure scenario and formulation

35. 35 Residential Post-Application Exposure Exposure to pesticide residues that occurs after the pesticide treatment.

36. 36 Incidental Oral Scenarios for Children Hand-to-Mouth** Object to Mouth (includes grass) Soil Ingestion Episodic Product Ingestion ** Common to most residential postapplication scenarios.

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38. 38 Residential SOPs: Summary of Updates (1) Dermal Pathway Incorporation of additional exposure monitoring data Inhalation Pathway Incorporation of additional exposure monitoring data Incorporation of indoor air exchange rates and outdoor wind speed to estimate air concentrations Hand-to-Mouth Pathway Child-specific hand/object-to-mouth observational monitoring Revision to mechanics of hand/object residue loading model Potential incorporation of house dust ingestion methodology Dec 2009 SAP to Discuss Issues about Volatilization and Spray Drift Incorporate Environmental Justice (EJ) implications and considerations

39. 39 Point Estimates to Distributions Distributional analysis Test for distribution-type (e.g., lognormal) Shapiro-Wilk, Kolomogorov-Smirnoff, etc. Data combination / separation Test for differences between application exposures, gardening activities, etc. Mann-Whitney, t-test, ANOVA Residential SOPs: Summary of Updates (2)

40. 40 Scenario Additions/Innovations Horse Barns Misting Systems Candles, Coils, Torches & Mats Gardens and Trees - ingestion of fruit/vegetable following pesticide application (children only) Estimates for residue and amount consumed Application Intervals & Residue Dissipation Time-weighted average exposure Residential SOPs: Summary of Updates (3)

41. 41 Future Directions In process of incorporating peer-review comments from Scientific Advisory Panel Continue to revise SOPs as new data and information becomes available Particularly interested in testing protocols that can help standardize data reporting Move from deterministic to probabilistic risk assessments

42. 42 Resources Residential SOP Scientific Advisory Panel Peer-Review, Background Materials, and Public Comments Available at www.regulations.gov Search: �EPA-HQ-OPP-2009-0516�

43. 43 Acknowledgments U.S. EPA Residential SOP Workgroups Office of Pesticide Programs, Health Effects Division Office of Research & Development, National Exposure Research Laboratory National Capital Area Environmental Health Association (NCAEHA)

44. 44 Questions