UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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:
You must apply in person to read (or copy) a docket.