Page 1 of 5 Ha UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C., 20460

OFFICE OF
CHEMICAL SAFETY AND
POLLUTION PREVENTION

January 7, 2011

MEMORANDUM

SUBJECT: Materials for Review by the Human St udies Review Board for its January 2011 Meeting

TO: Jim Downing Designated Federal Official
Human Studies Review Board Office of Science Advisor (8105R)

FROM: William L. Jordan Senior Policy Adviser Office of Pesticide Programs (7501P)

This memorandum describes the materials EPA’s Office of Pesticide Programs is providing for review by the Human Studies Revi ew Board (HSRB or Board) at the meeting scheduled for January 26, 2011. At this meeting, EPA will ask the Board to address scientific and ethical issues surrounding thes e two topics, each of which is discussed further below:

1. A new scenario design and associated prot ocol from the Agricultural Handler Exposure Task Force (AHETF) describing proposed rese arch to monitor exposure of workers who perform open mixing/loading of pesticide end use products formulated as wettable powders (AHE80)

2. A report from the AHETF of completed rese arch monitoring the exposure of workers applying pesticide sprays to or chard and trellis crops with closed-cab airblast equipment (AHE55, 56, 57, 58, 59)Page 2 of 5 1. Proposed research on the exposure of wo rkers mixing and load ing pesticide end-use products formulated as wettable powders (AHE80)

In several previous meetings, the HSRB has considered the design and conduct of research to measure the levels of exposure re ceived by professionals who mix, load, or apply pesticides using various types of equipment. Both agricultural and antimicrobial pesticide
handler scenarios have been considered. At th is meeting, the Board will consider a proposal for research monitoring exposure of workers w ho perform open mixing and loading of end use pesticide products formulated as wettable powders. This proposal is generally similar to others the Board has seen before from the Agricultu ral Handler Exposure Task Force (AHETF).

Because the proposed research involves sc ripted exposure, it meets the regulatory definition of “research involving in tentional exposure of a human subject” and thus is covered by subparts K and L of EPA’s amended rule for the protection of human subjects of research. The rule at 40 CFR §26.1125 requires a s ponsor or investigator to s ubmit to EPA, before conducting a study involving intentional exposure of human subjects, the protocol and related materials describing the proposed human research. In addition, EPA’s regul ation at 40 CFR §26.1601 requires EPA to perform science and ethics revi ews of the submitted proposal and to seek HSRB review of the proposed research.

EPA has reviewed the scenario design and protocol for AHE80, and has concluded that the research is likely to gene rate scientifically sound, useful information and, with minor revisions, to meet the ap plicable provisions of the EPA regul ations in 40 CFR part 26, subparts K

and L.

EPA is providing for HSRB review the follo wing three document s concerning this research proposal:

a. AHE80 Protocol - Submission for HSRB Review in Jan 2011

b. Supplement 1 for AHE80

c. EPA Science and Ethics Review for AHE80

Charge Questions :

If the revised AHETF scenario and field st udy proposal AHE80 is revised as suggested in
EPA’s review and if the research is performed as described:

a. Is the research likely to generate scientif ically reliable data, us eful for assessing the exposure of handlers who perform open mi xing and loading of pesticide end use products formulated as wettable powders?

b. Is the research likely to meet the appli cable requirements of 40 CFR part 26, subparts

K and L?Page 3 of 5 2. Completed AHETF research on exposure of workers applying pesticide sprays using closed-cab airblast equipment.

In June and October 2008, the HSRB reviewed five protocols for research to measure the levels of dermal and inhalation exposure receive d by pesticide applicators who spray pesticides with closed cab airblast equipment. Followi ng favorable HSRB reviews and after revisions to address EPA, HSRB, and California DPR comments , this research was conducted in summer/fall 2008 and spring/summer 2009. The completed reports and monograph were submitted to EPA
in November 2010.

If the data for the Closed Cab Airblast A pplicator Scenario ar e accepted by EPA, the resulting data will be added to the Agri cultural Handler Exposure Database (AHED ® ). EPA intends to use these data generically to estim ate daily dermal and inhalation exposures of workers who treat agricultural crops with conven tional pesticides using closed-cab airblast equipment. If considered appropriate, data from this scenario addressing exposures from closed cab airblast pesticide applications will be combined with data from an appropriate mixing/loading scenario to estimate exposures of workers who both mix/load and apply.

Because this research involved scripted e xposure, it meets the regulatory definition of “research involving inten tional exposure of a human subject” and thus is covered by subparts K and L of EPA’s amended rule for the protection of human subjects of res earch. The rule at 40 CFR §26.1303 requires the submitter of reports of completed human research to document its ethical conduct. The rule at 40 CFR §26.1602(a) requires EPA to “review the material submitted under §26.1303 and other available, relevant info rmation, and [to] document its conclusions regarding the scientific and ethical conduct of the researc h.” The rule at 40 CFR §26.1602(b) further requires EPA to submit the data and EPA’ s review to the HSRB if it decides to rely on
the data.

EPA has reviewed the AHETF completed study reports, IIRB correspondence reports, and monograph, and has concluded that the res earch provides scientif ically sound, useful information, and was conducted in substantial co mpliance with the ethics requirements at 40 CFR part 26, subparts A through L.

EPA is providing for HSRB review the followi ng documents concerning these completed studies and monograph:

Background Documents (Submit ted to EPA by the AHETF)

File Name 1. AHE55 Final Cluster Report – November 2010 2. Final AHE55 IIRB Correspondence Report – November 2010 3. AHE56 Final Cluster Report – November 2010 4. Final AHE56 IIRB Correspondence Report – November 2010 5. AHE57 Final Cluster Report – November 2010 6. Final AHE57 IIRB Correspondence Report – November 2010Page 4 of 5 Background Documents (Submit ted to EPA by the AHETF)

6a. Supplement 1 for AHE57 7. AHE58 Final Cluster Report – November 2010 8. Final AHE58 IIRB Correspondence Report – November 2010 9. AHE59 Final Cluster Report – November 2010 10. Final AHE59 IIRB Correspondence Report – November 2010 11. CCAB Monograph Report - FINAL

EPA Science Reviews

File Name

1. EPA Science Review of AH ETF CCAB Completed Studies 2. EPA Science Review of AHETF CCAB Monograph

Supporting Files for Science Revi ew (Excel and SAS files)

File Name 1. AHE55 Calcs-Carbaryl-NO MEC-11-30-10_FINAL QA'd.xls

2. AHE55 Calcs-Malathion-NO MEC-11-30-10_FINAL QA'd.xls 3. AHE56 Calcs-Carbaryl-NO MEC-11-30-10_FINAL QA'd.xls

4. AHE56 Calcs-Malathion-NO MEC-11-30-10_FINAL QA'd.xls

5. AHE57 Calcs-chlorothalonil- No MEC-11-30-10_FINAL QA'd.xls

6. AHE58 TDE Calcs-Malathion-No MEC-11-22-10_FINAL QA'd.xls 7. AHE59 TDE Calcs-Carbaryl-No MEC-11-22-10_FINAL QA'd.xls

8. CCAB-scenario calcs-No MEC-to EPA on 11-22-10.xls

9. CCAB-scenario calcs-with MEC-to EPA on 11-22-10.xls 10. CCAB-QAd-Final - 11-8-10.csv 11. CCAB-with MEA-QA'd_FINAL 6- 10-10 - EPA vers 6-15-10.csv 12. Eval_CCAB.sas 13. Macro_GetEmpStats.sas 14. Macro_NormScores.sas 15. Macro_ObjEval_CCAB.sas
16. Macro_TestVCs_CCAB.sas

EPA Ethics Review

File Name 1. EPA Ethics Review of AHETF CCAB Completed StudiesPage 5 of 5 Additional Reference Files

File Name

1. EPA Science and Ethics Review s of CCAB Protocols – AHE55, AHE56

2. EPA Science and Ethics Reviews of CCAB Protocols – AHE57, AHE58, AHE59 3. HSRB Report covering CCA B Protocols – AHE55, AHE56 4. HSRB Report covering CCAB Protocols – AHE57, AHE58, AHE59 5. IIRB, Inc. Roster and Procedures

6. AHETF SOPs 7. AHETF Governing Document

Charge Questions :

a. Was the research reported in the Agricu ltural Handler Exposure Task Force (AHETF) completed monograph report and associated fi eld study reports faithful to the design and objectives of the protocol, SOPs, and governing documents?

b. Has the Agency adequately characterized, from a scientific perspective, the

limitations on these data that should be c onsidered when using the data in estimating exposure of those who apply conventional pesticides with closed cab airblast equipment?

c. Does available information support a determ ination that the studies were conducted in substantial compliance with subpa rts K and L of 40 CFR Part 26?