EPA Risk Assessment Review Process

Process Steps




Receipt and Administrative Preparation


Focus Meeting


Preliminary Report Preparation


Work-Plan Meeting


Risk\Benefit Analysis and Science Review


Mid-Course Meeting


Report Finalization and Integration of Findings


Final Reports Meeting


Final Report:  Hazard\Risk


Options Meeting


Brief Division Directors

Biosafety Science
Estimate Hazard
Estimate Exposure
Risk Assessment and Characterization
Risk Management
Protocols and Procedures
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

[ Previous Step ]

[ Start ]

[ Next Step ]

Last Modified: May 21, 2001
Bionomics International
12231 Parklawn Drive
Rockville, Md. 20852