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Notifications under TSCA Section 5
If a person wishes to commercialize an intergeneric microorganism, or to introduce such microorganisms into the environment for research purposes, EPA's final biotechnology regulation under the Toxic Substances Control Act (TSCA) requires the submission of certain information to Office of Pollution Prevention and Toxic Substances (OPPT). Persons who wish to commercialize an intergeneric microorganism must submit a Microbial Commercial Activity Notice (MCAN) to EPA at least 90 days prior to commercialization. Persons who wish to introduce an intergeneric microorganism into the environment for commercial research and development purposes must submit a TSCA Experimental Release Application (TERA) to the Agency at least 60 days prior to initiation of the field test.
Upon receipt of the submission, OPPT scientists review the information provided to determine whether the intended activity may present an unreasonable risk to health or the environment. Decisions on what action to take for each submission are based upon these reviews. For more information on how to prepare a submission, please refer to Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (PDF) (71 pp, 1.3MB, about PDF). For information on the requirements for submitters, please refer to the Final Rule Fact Sheet, or the biotechnology regulation.
The Status Report below lists brief information about biotechnology submissions from FY 1987 through FY 1997. The Notifications Table lists only those submissions received under the biotechnology regulation, beginning in FY 1998. From this table, you can link to a brief summary of each submission and, in many cases, to a fact sheet on the decision reached by OPPT. The Items of Interest page contains fact sheets, actions or other items that do not fit into the Status Report or Notifications Table.