EPA Risk Assessment Review Process

Process Steps

 1.

Introduction

 2.

Receipt and Administrative Preparation

 3.

Focus Meeting

 4.

Preliminary Report Preparation

 5.

Work-Plan Meeting

 6.

Risk\Benefit Analysis and Science Review

 7.

Mid-Course Meeting

 8.

Report Finalization and Integration of Findings

 9.

Final Reports Meeting

10.

Final Report:  Hazard\Risk

11.

Options Meeting

12.

Brief Division Directors

Science
Biosafety Science
Estimate Hazard
Estimate Exposure
Risk Assessment and Characterization
Risk Management
Protocols and Procedures
Examples
EPA Risk Assessment Review Process

Midcourse Meeting
Timeline:  Day 49

Reports (hazard, exposure and risk benefit) and general conclusions are discussed. Need for additional information or expertise considered.

Midcourse Meeting Content

The mid course meeting is an indepth presentation of hazard and exposure findings and tentative conclusions. Reports on the taxonomy of the microorganism, production (volume, procedures, etc), and general procedures (engineering) to produce the product are also presented. The result is a complete picture of the project. The information forms the basis for risk/benefit analysis, which begins indepth after the midcourse meeting. R/B input is not needed until after final reports from hazard, exposure and engineering are inhand and may affect the management decisions and selection of options


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Last Modified: November 14, 2000
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Bionomics International
12231 Parklawn Drive
Rockville, Md. 20852