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

Receipt and Administrative Preparation
TimeLine:  Day 0-5

Receipt and Log-in of Application

Receipt of an application (known as a PMN : Pre Manufacture Notice) begins the review process. The application is formally logged in and the 90 day review period is formally initiated. The docket established. This will be available to the public after completion of the review, although confidential business information will be deleted. The agency may share the application if it is deemed relevant to the mission of USDA or FDA.

Activity in Preparation For Review

The PMN is reviewed for completeness. Copies are made and distributed to appropriate groups. The technical manager, responsible for coordination of the review effort, is appointed. The calendar is established and dates for reports from reviewers and meetings scheduled; meeting dates will vary slightly, but the 90 day limit requires a tight scheduling of activities and close coordination of activities.

During this time period reviewers are developing preliminary understandings of the issues involved in the review for the focus meeting. No attempt at in depth analysis is made.

Additional Organizational Information

Reviewing Office

 The Office of Pollution Prevention and Toxics conducts the review and reports to the Assistant Administrator for prevention, pesticides, and toxic substances. The office consists of 8 branches, 4 of which are involved in the review process. Once the application is logged in, the 90 day “clock” begins. Only the applicant can suspend the clock.  Logging in of applications, examination for completeness and establishing and maintaining the overall calendar is the responsibility of the Information Management and Chemical Control branches. The  Chemical Control branch also determines whether the application is for a product subject to TSCA and whether there have been examinations of similar products.

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Last Modified: May 21, 2001
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