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

RISK ASSESSMENT
IN
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
 UNDER
 TOXIC SUBSTANCES CONTROL ACT

The EPA Risk Assessment review process is guided by the provisions in Toxic Substances Control Act (TSCA).  TSCA requires that the review be completed in 90 days, that it be comprised of  a comprehensive evaluation of potential adverse effects that may affect human health or the environment and a consideration of the benefits involved. The Act also specifies management options, both for conducting the assessment and for establishing conditions under which a product may be produced and utilized.  The Agency has developed a procedure to meet these requirements. While many applications are received without prior agency contact, the agency encourages preapplication consultation. See EPA web site or contact Biotechnology Program Manager at 202-260-1857.

A review includes administrative activity (eg logging in, record keeping), specific scientific examination of relevant data and development of options for management, and results in a management decision. The review process is conducted within the Office of Pesticide Prevention and Toxics.

The following generalized description of the review procedure uses a bioremediation application (PMN 95-1601),  involving a recombinant microorganism as an example. A complete docket is available through the EPA, as are reports of all reviews.  The EPA Docket is located at:

        TSCA Information Center
        Waterside Mall
        401 M St. SW
        Washington,  D.C. 20460
        Hours: 12:00 P.M. - 4:00 P.M.  Monday-Friday

You must apply in person to read (or copy) a docket.

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