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

Final Report: Hazard\Risk
Timeline:  Day 70

Presentation and discussion of Hazard\Risk findings

Cost estimates and findings from all review groups are presented and integrated in a final  assessment. A briefing paper is outlined, detailing the findings and the management options.

Description of Finalization Meetings; Input From Risk/Benefit Analysis

Final reports of hazard, risk, engineering, and benefits (maybe links to above) are discussed and integrated. 

 The risk/benefit analysis covers the market context (how it will be used, cost advantage, efficacy relative to other products, scope and safety), possible products for which the new product could substitute, and any benefits. In the PMN95 1601 example is it safer, more effective, or faster etc. However, PMN95 1601 is not for a commercial product: it is a test to determine if the idea is feasible. In this case, information is considered the benefit. The test is seen as advancing the science of bioremediation by providing information which could lead to safer, faster, or cheaper remediation procedures. Nevertheless, possible substitutions were considered as if a commercial product could develop from the test. These included new bioremediation methods and new monitoring methods. These findings will affect the selection of management options. Option discussion and report integration is completed during days 70-78.

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Last Modified: May 21, 2001
Bionomics International
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