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  SEQ CHAPTER \h \r 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460



  SEQ CHAPTER \h \r 1 OFFICE OF

PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

June 18, 2008

MEMORANDUM

SUBJECT:	Transmission of additional materials for review by the Human
Studies Review Board for its June 2008 Meeting

TO:		Paul I. Lewis, Ph.D. 

		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 additional materials OPP is providing for
review by the Agency’s Human Studies Review Board (HSRB or Board) at
the meeting scheduled for June 24-25, 2008.  These materials consist of
reviews of the sampling strategy proposed in the protocols submitted by
the Agricultural Handlers Exposure Task Force (AHETF) describing
research to monitor exposure of subjects who apply an agricultural
pesticide using airblast equipment in closed cabs (“CCAB
protocols”). These reviews were prepared under a contract with EPA by
Dr. Louise Ryan, Harvard University, and Warren Strauss, Battelle
Memorial Institute (Battelle).  

Let me provide some background.  As you know, in previous meetings the
Board has raised issues concerning the sampling strategies being
proposed by the industry task forces that are planning to conduct
research to develop data on handler exposures to pesticides.  As a
consequence of these discussions, in late 2007 EPA contacted Dr. Louise
Ryan, Chair of the Department of Biostatistics at the Harvard University
School of Public Health, who agreed to help the Office of Pesticide
Programs (OPP) in its review of proposed handler exposure protocols. 
The Agency eventually arranged to obtain the services of Dr. Ryan
through a contract with Battelle.  Dr. Ryan collaborated with Warren
Strauss, a statistician at Battelle.  

In April OPP provided Ryan and Strauss with the CCAB protocol materials
submitted by the AHETF, as well as EPA’s reviews of the CCAB protocols
and information about the discussions among EPA, the Board, the industry
task forces, and Dr. Maiti.

In late May, Ryan and Strauss provided an initial review in which they
recommended that EPA should consider asking the AHETF to replace the
proposed purposive diversity sampling strategy with a stratified,
probability-based sampling strategy in order to strengthen the design. 
In OPP’s view, the Ryan and Strauss recommendations rested on mistaken
assumptions about the costs and technical feasibility of their suggested
alternative proposal. Accordingly, we discussed with them our
perceptions of the practical implications of their approach and, in a
written work assignment, asked them to consider certain questions and,
if appropriate, to revise or supplement their initial review.  On June
6, they provided a supplemental report.  The June 6 supplement contains
OPP’s questions as an attachment.

At the June meeting OPP intends to address the comments made by Ryan and
Strauss in our presentations to the HSRB on the CCAB protocols.  

I will separately transmit to you electronic files containing the
following Ryan and Strauss documents: 

1.  "Review of AHETF Sampling Design Documentation" by Warren Strauss
and Louise Ryan (May 22, 2008) (17 pages).  

2. “Supplemental Materials in Response to EPA Follow-up Questions”
by Warren Strauss and Louise Ryan (June 6, 2008) (4 pages). 

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