AHETF Scenario Design and Field Study Protocol for Mixing and Loading of Pesticide Products in Water-Soluble Packaging

1. AHETF Scenario Design and Field Study Protocol for Mixing and Loading of Pesticide Products in Water-Soluble Packaging Jeff Evans Kelly Sherman Office of Pesticide Programs 1

2. AHETF Status Recap June 2008: HSRB reviewed the closed-cab airblast scenario Fall 2008: AHETF conducted 2 closed-cab airblast field studies October 2008: HSRB reviewed the remaining field study protocols for the closed-cab airblast scenario HSRB reviewed the scenario design document and field study protocols for the open-cab airblast scenario Summer 2009: AHETF plans to conduct several closed-cab and open-cab airblast field studies 2

3. What’s Familiar about this Proposal? • No change to AHETF Governing Document or most SOPs • Design objectives, sample size and rationale, and cluster configuration are all similar to other AHETF scenarios reviewed • Protocol procedures related to ethical conduct are similar, but all issues raised by EPA and HSRB have all been addressed

4. What’s Different about this Proposal? • Monitors Mixer-Loaders; crop is unimportant • Scenario covers mixing dry pesticides in water-soluble packets (WSPs) with water, and loading the solution into various types of equipment for application as liquid sprays • Liquid sprays may be applied to virtually all types of crops, using a wide range of application equipment, in all areas of the U.S. • New Format for AHETF – a single protocol covers all five proposed field study sites • 12 new or updated SOPs • One new surrogate – acephate

5. AHETF Scenario Design and Field Study Protocol for Mixing and Loading of Pesticide Products in Water-Soluble Packaging:Science AssessmentJeff EvansHealth Effects Division 5

6. Scenario Definition • Mixing/Loading soluble or wettable powder pesticides enclosed in water-soluble packets (WSP) • Scenario supports assessing WSP mixing/loading for many crops under 3 sub-scenarios: • Mixing of WSPs directly into the tank used for the pesticide application • Mixing of WSPs into a "pre-mix" tank at the same concentration to be applied to the crop • Mixing of WSPs into a tank as a concentrated solution/suspension that must be further diluted and transferred to the final application tank

7. EPA Position on Scenario Definition • We agree with the AHETF plan to informally diversify these general equipment types • Each of the three sub-scenarios must be monitored at least once within each cluster • Diversity will be achieved—randomly or purposively—by assigning mixer/loaders to Amount-active-ingredient-Handled (AaiH) strata within each cluster • The proposal for 25 subjects in 5 clusters of 5 subjects each is appropriate for this scenario

8. Regulatory Requirements for PPE • Minimum Personal Protective Equipment (PPE) permitted by the Worker Protection Standard for acephate and carbaryl when engineering controls are used is chemical-resistant gloves • Other attire includes: long sleeved shirt, long pants, shoes, socks • In case of emergency (e.g., bag rupture) other PPE: coveralls, chemical-resistant footwear, and respirators must be available

9. Inner Dosimeter Example

10. Water-Soluble Packets Packets containing dry flowable product

11. Packets may be placed directly into the sprayer tank

12. Packets may also be placed into a variety of holding tanks, either fully diluted for use or as a concentrated solution for later further dilution and transfer to a spray tank

13. Many kinds of tanks are used

14. Tanks may be indoors or outdoors

15. Portable mixing stations may also be set up

16. Lynn County, OR Russ Glover To accompany a variety of application scenarios

17. Proposed Surrogate Pesticides • EPA accepts the AHETF’s selection of acephate and carbaryl as surrogates • They are widely used and available in water soluble packets • They are used on a wide range of crops on farms of many sizes and types such that all AaiH strata can likely be filled in each cluster • They have reliable analytical methods, have been successfully used as surrogates in other AHETF studies, and are known to have the required stability under field study conditions

18. Margins of Exposure for Maximum AaiH

19. Proposed AaiH Strata • All exposure durations will be at least 4 hours • Each subject will mix/load at least 3 tanks of spray mixture • Five strata of AaiH in each cluster: • 5 to 17 pounds ai handled • 18 to 55 pounds ai handled • 56 to 182 pounds ai handled • 183 to 603 pounds ai handled • 604 to 2,000 pounds ai handled (limit use of acephate to 700 pound AaiH)

20. Proposed Clusters

21. Conclusions of Science Assessment • The Field and Laboratory QA/QC aspects are robust • The Scenario is well defined • This protocol has addressed the technical aspects of applicable exposure monitoring guidelines • Draft - EPA Series 875 Group A - Applicator Monitoring Test Guidelines • OECD Applicator Guidelines • Good Laboratory Practices (GLPs) (40CFR Part 160) • Limit AaiH of acephate to 700 pounds

22. AHETF Scenario Design and Field Study Protocol for Mixing and Loading of Pesticide Products in Water-Soluble Packaging:Ethics Assessment Kelly Sherman Human Research Ethics Reviewer Office of Pesticide Programs 22

23. Value to Society • Exposure data for workers who mix and load pesticides contained in water-soluble packets are needed to support EPA risk assessments • Studies conducted under this protocol will constitute the entire exposure data set for this scenario in the Agricultural Handler Exposure Database (AHED®) • Knowledge likely to be gained will be used to estimate dermal and inhalation exposure from use of a wide range of agricultural pesticides available in water-soluble packets 23

24. Recruiting and Consent • Equitable subject selection • Fully informed choice • Fully voluntary choice • Respect for subjects 24

25. Risks, Benefits, and Risk-Benefit Balance • Risks have been fully identified and effectively minimized • Residual risks to subjects will be low • Risks to subjects are reasonable in light of potential societal benefits 25

26. Independent Ethics Review • The Independent Investigational Review Board (IIRB) of Plantation FL: • Reviewed and approved the protocol and informed consent materials • Is independent of the sponsors and investigators • Is registered with OHRP • Is seeking accreditation from AAHRPP • IIRB’s “Human Research Protection Program Plan” was included among the LNX-002 materials 26

27. EPA Review • No deficiencies relative to 40 CFR 26, subparts K and L, or to FIFRA 12(a)(2)(P) • All issues identified in previous EPA and HSRB reviews have been satisfactorily addressed • 21/24 issues addressed in the Scenario Design and Field Study Protocol (dated 1/16/09) • 3 remaining issues addressed in the AHETF’s Response to EPA’s Science and Ethics Review (dated 5/12/09) 27

28. Representativeness • Concern: Are study participants representative of the target population of growers and commercial applicators? • Past AHETF efforts to address concern were unsuccessful • New AHETF Proposal: • Characterize eligible growers – both those willing and unwilling to participate • Ask experts with local knowledge to assess characteristics of willing and unwilling growers in terms of representativeness • EPA View: AHETF proposal is effective and ethically acceptable

29. Presentation of Individual Exposure Data • Concern: Workers who learn that their exposure is lower than average might become complacent or adopt riskier behavior • AHETF proposal: • Letter conveying the importance of diligence in the handling of pesticides, regardless of the worker’s individual exposure levels • Graphics depicting exposure distribution across body parts for the individual worker and the group average • EPA brochure describing safe practices for pesticide handlers • EPA View: AHETF proposal is effective and ethically acceptable

30. Localization of Spanish Translations • Concern: Spanish translations should reflect specific terminology and wording common to the study locale • AHETF proposal: • Modify documents as appropriate to meet local needs • Contact people in different regions of the country who provide pesticide safety training to Spanish-speaking agricultural workers • Ask reviewers to suggests changes in wording that would improve understanding in their geographic area • Ask reviewers to suggest translations for certain agricultural terms • EPA View: AHETF proposal is effective and ethically acceptable

31. Applicable Ethical Standards Proposal for third-party research involving intentional exposure of human subjects to a pesticide, with the intention of submitting the resulting data to EPA under the pesticide laws The primary ethical standards applicable to the conduct of this research are 40 CFR 26, Subparts K and L 31

32. Conclusions of Ethics Assessment • Protocol meets the applicable requirements of 40 CFR part 26, subparts K and L

33. Charge Questions If proposed field study protocol AHE120 is revised as suggested in EPA’s reviews and if the research is performed as described: 1. Is the research likely to generate scientifically reliable data, useful for assessing the exposure of handlers who mix and load soluble or wettable powder pesticides in water-soluble packaging? 2. Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L? 33