Procedures Used in the US for Evaluation of Wood Protection Chemicals

1. Procedures Used in the US for Evaluation of Wood Protection Chemicals Frank Sanders, Director Antimicrobials Division Office of Pesticide Programs US Environmental Protection Agency

2. OPP’s Pesticide Risk Assessment Process - Overview • Science disciplines • Statutes: FIFRA & FFDCA • Part 158, Subpart W • Risk process: characterization, mitigation, benefits, management

3. OPP’s Pesticide Risk Assessment Process: Science Areas • Science disciplines • Toxicology • Human exposure • Product chemistry • Residue chemistry • Fate chemistry • Environmental exposure • Ecological effects

4. OPP’s Pesticide Risk Assessment Process: Statutes - FIFRA • FIFRA provides statutory framework for pesticide regulation • FIFRA gives EPA authority to require testing by registrants/applicants • FIFRA requires that pesticide will not cause “unreasonable adverse effects” on human health or environment

5. OPP’s Pesticide Risk Assessment Process–FIFRA Statutory Criteria • Unreasonable Adverse Effects - 2(bb): • “…(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or…”

6. OPP’s Pesticide Risk Assessment Process–FIFRA Statutory Criteria • Unreasonable Adverse Effects - 2(bb)…cont: • “…(2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act…”

7. OPP’s Pesticide Risk Assessment Process: Statutes – FFDCA Section 408 • Food uses: FFDCA sec. 408 applies and tolerance/exemption from tolerance is required for pesticide residues in food and/or animal feed • Pesticide residue: A combination of a pesticide and/or its metabolites, degradates, transformation products that remain on food/feed after the application of the pesticide

8. OPP’s Pesticide Risk Assessment Process–FFDCA Statutory Criteria • “Determination of Safety…the term ‘safe’, with respect to a tolerance…means…there is a reasonable certainty that no harm will result from aggregate exposure…including all anticipated dietary exposures and all other exposures for which there is reliable information.”

9. OPP’s Pesticide Risk Assessment Process–FFDCA Statutory Criteria • “EXPOSURE OF INFANTS AND CHILDREN…the Administrator…shall assess the risk…of such residues that have a common mechanism of toxicity; and…shall…ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue…”

10. OPP’s Pesticide Risk Assessment Process–Part 158, Subpart W • Part 158, Subpart W, intended to be concise presentation of what data are required for each pesticide use pattern • Linked to guidelines for test methods, series of documents titled “Pesticide Assessment Guidelines” • Guidelines set forth acceptable protocols, test conditions, and data reporting requirements to meet each data requirement in Part 158, Sub W

11. OPP’s Pesticide Risk Assessment Process–Part 158, Subpart W • Part 158, Subpart W, data allow OPP to: • Establish baseline on each Technical Grade Active Ingredient (TGAI) • Determine labeling and classification of products/use patterns • Enable Agency to complete risk characterizations: human dietary/non-dietary (occupational/residential) and environmental

12. OPP’s Pesticide Risk Assessment Process–Part 158, Subpart W, Use Categories • Agricultural premises and equipment • Food handling/storage establishments premises and equipment • Commercial, institutional and industrial premises and equipment • Residential and public access premises • Medical premises and equipment • Human drinking water

13. OPP’s Pesticide Risk Assessment Process–Part 158, Subpart W, Use Categories • Materials preservatives • Industrial processes and water systems • Antifouling coatings • Wood preservatives • Swimming pools • Aquatic areas • HVAC (highlighted because of high exposure concerns)

14. OPP’s Pesticide Risk Assessment Process–Risk Characterization • Hazard x Exposure = Risk • Risks based upon: • Toxicity (hazards) • Exposure…such as… • Uses • Application methods • Application locations (e.g., industrial, residential) • Duration: no. applications, persistence of residues • Pesticide chemical characteristics (e.g., volatility)

15. OPP’s Pesticide Risk Assessment Process–Risk Characterization • Determine who/what organisms are exposed: • Humans (e.g., applicators, homeowners, children, infants)? • Environmental (e.g., terrestrial, aquatic, endangered species)?

16. OPP’s Pesticide Risk Assessment Process–Risk Characterization (Humans) • Selection of hazard endpoint (mammals) • Route of exposure (inhalation vs dermal vs oral) • Duration of exposure (acute, short- or intermediate-term, or chronic) • Toxic effect (developmental, cholinesterase inhibition, liver toxicity, etc.) • Cancer effects: expressed as potency factor (Q1*) • Non-cancer effects: expressed as NOAEL (No-observable-adverse-effect level)

17. OPP’s Pesticide Risk Assessment Process–Risk Characterization (Humans) • Determination of Exposure Levels • Method of application • Duration and frequency of exposure • What clothing/equipment is being worn • Levels typically expressed in mg/kg/day • Application rate

18. OPP’s Pesticide Risk Assessment Process–Risk Characterization (Humans) • Cancer risks: • Generally expressed as probability • Any exposure level results in potential risk • One in million is our goal (1x10-6) • Residential versus occupational

19. OPP’s Pesticide Risk Assessment Process–Risk Characterization (Humans) • Non cancer risks – MOE approach • MOE = Margin Of Exposure • MOE = Hazard/Exposure • Hazard: typically use NOAEL • Exposure = daily amount of antimicrobial to which person is exposed • Goal: typically MOE > 100 (10 interspecies uncertainty factor and 10 intra-species uncertainty factor) • Believe larger MOE is better – greater distance between exposure and where adverse effects are observed

20. OPP’s Pesticide Risk Assessment Process–Risk Characterization (Environmental) • Similar approach as for humans: • Here MOE = RQ (Risk Quotient) • RQ = Exposure/Hazard • RQs compared to Levels of Concern (LOCs) • EEC = Estimated Environmental Concentration • LOCs established by OPP as criteria for determining potential environmental risk

21. OPP’s Pesticide Risk Assessment Process–Risk Characterization (Environmental) • RQ & LOC Examples: • Aquatic animals acute high risk • EEC/LC50 or EC50 > 0.5 (LOC) • Endangered aquatic animals acute risk • EEC/LC50 or EC50 > 0.05 (LOC) • Aquatic animals chronic risk • EEC/MATC or NOEC > 1 (LOC)

22. OPP’s Pesticide Risk Assessment Process–Risk Mitigation • For unacceptable or high risks (MOEs/RQs) • Undertake risk mitigation (refine risks) • Reduce application rates/frequency of application • Increased protective measures (e.g., protective clothing, engineering controls, etc) • Submit additional data (hazard, exposure) • Cancel/remove use

23. OPP’s Pesticide Risk Assessment Process–Risk Mitigation • For reregistration typically involves: • Interaction with registrants, public, stakeholders, users • Negotiation with registrants to refine risks to achieve risk mitigation • Public process with public having opportunity to respond • For registration OPP works with individual registrants

24. OPP’s Pesticide Risk Assessment Process–Schedules • Reregistration • Food uses – by August 2006 • Non-food uses by August 2008 • Registration • Ongoing • Registration Review • Starts in 2006 • Every 15 years

25. OPP’s Pesticide Risk Assessment Process–Benefits Analyses • What is the mandate for conducting benefits analyses? • What are elements of a benefits analysis? • Types of analyses and data sources • Characterizing real-world benefits • What does EPA analyze for specific types of worker risk mitigation?

26. OPP’s Pesticide Risk Assessment Process–Benefits Analyses • Interpretation of benefits: • For agricultural pesticides a benefits analysis will focus on the impacts on farmers, farm productivity, and consumer costs associated with farm productivity. (Federal Register, Vol. 41 – 1976)

27. OPP’s Pesticide Risk Assessment Process–Benefits Analyses • What may trigger a benefit analysis? • For risk of concern with very low usage: • Presume low benefits and verify through USDA and stakeholders • For risk of concern coupled with significant usage: • Conduct a benefit analysis to determine importance of use

28. OPP’s Pesticide Risk Assessment Process–Benefits Analyses • Elements of benefits analysis include: • 1. Development of information about pesticide use patterns • 2. Evaluation of alternative pesticides or pest control practices • 3. Analysis of impacts of risk management options • 4. Analysis of impacts of risk mitigation options

29. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (develop information about pesticide use patterns) • Determine real-world pesticide use patterns: • Crops/sites treated – and extent of use • Major pests controlled – and type of damage • States or regions with the most use • Timing – relative to cropping pattern • Method of application, frequency, formulation, rates, etc.

30. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (develop information about pesticide use patterns) • Information sources: • Usage data • USDA NASS Agricultural Chemicals Survey • California Pesticide Use Data • DOANE and other proprietary sources • USDA Crop Profiles • Other USDA documents • Agricultural Statistics • Census of Agriculture • Crop experts and/or pesticide users

31. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (evaluation of alternative pesticides or pest control practices) • Identify pesticide alternatives: • Major pests controlled • Surveys of pesticide users, published literature • States or regions with the most use • Timing • What else is used at the same time?

32. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (evaluation of alternative pesticides or pest control practices) • Evaluate alternatives: • Pest Spectrum: Does it control the same pests? • Method of application – is it feasible? • Timing – does it interfere with cropping system? • Frequency • Rates

33. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (evaluation of alternative pesticides or pest control practices) • Information sources: • Efficacy/comparative product performance data • State recommendations (extension publications) • Field experts

34. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (analysis of impacts of risk management options) • What are potential grower responses to use restrictions or absence of pesticide? • Identify alternate chemical or non-chemical control measures for each major pest • Evaluate whether users will implement proposed risk mitigation or substitute alternative pest control method

35. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (analysis of impacts of risk management options) • Estimate Changes in Crop Yield, Quality or Degree of Pest Control: • Yield loss estimates based on comparative performance analysis, expert opinion or best professional judgment • Also consider impacts on IPM, resistance management, crop production management practices, and secondary pest outbreaks

36. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (analysis of impacts of risk management options) • Estimate potential economic impacts: • Grower level impacts • Changes in control or production costs • Value of yield/quality losses • Relative impact to individual growers • Aggregate impacts • Market and consumer impacts

37. OPP’s Pesticide Risk Assessment Process–Benefits Analyses (analysis of impacts of risk mitigation options) • Additionally, evaluate risk mitigation options: • e.g., if reduce application rate: • What percentage of uses will be affected by a rate reduction? • What are efficacy and quality issues of reducing application rate? • What’s impact of using an alternative pesticide in lieu of reducing application rate?

38. OPP’s Pesticide Risk Assessment Process–Risk Management • Risk management decision based on: risk characterization(s), risk mitigation, regulatory considerations, and benefit analyses (when needed) • Risk managers and risk assessors are in continuous contact throughout the process • Benefit analyses do not always occur except as noted earlier • Generally, “weight-of-the-evidence” approach is used

39. OPP’s Pesticide Risk Assessment Process–Summary • Submission (registration) or decision to rereview (reregistration) • Submission and/or retrieval of pertinent exposure and hazard data/information • Review of exposure and hazard data/information • Exposure/risk characterizations • Risk mitigation/refinement • Benefits analysis • Risk management decision

40. OPP’s Pesticide Risk Assessment Process–Acknowledgements • Information for this presentation was obtained from various sources including: • Jack Housenger, Associate Director, Antimicrobials Division (AD) • Arnet (Skee) Jones, PhD, Branch Chief, Biological and Economic Analysis Division (BEAD) • Risk Assessment and Science Support Branch (RASSB) staff • BEAD staff