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March 1998 - Request for Evaluation of the Background Document

Request for Evaluation of the Background Document for the
March 24-25, 1998
FIFRA Scientific Advisory Panel Meeting Session
"Suggested Probabilistic Risk Assessment Methodology for
Evaluating Pesticides with a Common Mechanism of Toxicity:
Organophosphate Case Study"

OPP is requesting the review of the subject paper by the Scientific Advisory Panel (SAP). Since passage of the Food Quality Protection Act (FQPA) in August, 1996, OPP has worked to develop the science policy and tools to permit full implementation of the revised risk assessment policies required. In the process, OPP has evaluated a number of proposed approaches presented by the regulated industry and the public at large. Broad-based input has been sought through dialog with the regulated community, public interest groups, grower groups and the public at large. Specifically, OPP has entered into a cooperative agreement with the International Life Sciences Institute (ILSI) Exit EPA Disclaimerto develop white papers on scientific issues surrounding Common Mechanism of Toxicity and Aggregate Exposure Assessment. These papers have explored the many factors involved in conducting risk assessments as required by FQPA. ILSI has then provided a followup mechanism for seeking public comment on these issues by conducting workshops to discuss their findings. The results of this process are providing OPP with insights into the risk assessment process that are helpful in our final policy development.

Proposed methodologies have been provided in a variety of forms, including sample assessments from the regulated community and other interested parties. The attached document is an example of such a proposed methodology. OPP has evaluated the approaches for statistical validity, comformity with existing risk assessment policy, use of data, modifying factors, approaches to interweaving dietary and nondietary exposure data, and many other considerations. These examples have been informative and educational for OPP staff as they have developed increasing sophistication in considering risk assessment issues much greater complexity than previously encountered. Examples of completed assessements have provided valuable incite into the implications of differing assumptions in conducting risk assessments.

OPP wishes to continue to seek new ideas and develop our thinking on science policy issues through the venue of SAP evaluation of the attached sample methodology. OPP requests that the SAP focus on the methodology used in the example attached rather than the outcome of the sample assessment per se. In particular, OPP is seeking comment on what aspects of data use and process may be appropriate for inclusion in our continuing policy development process. Questions are provided to focus the Panel's attention on those areas of particular interest to OPP.

Scientific Advisory Panel (SAP) March 1998 Meeting

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