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Filing a Biotechnology Submission

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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.

How to File a Biotechnology Submission with EPA

If you submit a biotechnology submission for a microorganism ("biotech submission") to EPA, you are required to use the electronic-PMN ("e-PMN") software as described in 40 CFR 725.25 (PDF) (4 pp, 152K). Refer to www.epa.gov/cdx, the CDX Registration Guide (PDF) (44 pp, 8.5MB), or the CDX Helpful Hints (PDF) (10 pp, 41K) for directions on how to register and submit notices via CDX.

There is no required form for biotech submissions in the e-PMN software but you must use the e-PMN software "header sheet." In the opening screen of the e-PMN program, choose to create a new project and then select "Biotechnology." You will be required to enter contact information into the Header Sheet regarding the submitting company and the technical contact. There are five biotechnology submission choices covered in this module: MCANs, TERAs, Tier I and Tier II exemptions, and Biotechnology TMEAs. After selecting a submission type, you can enter the submission information in a cover letter and as attachments. Refer to the Helpful Hints for Use of the eTSCA/e-PMN Submission Software (PDF) (16 pp, 54K) for more information on how to submit notices using the e-PMN software.

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). For information on the requirements for submitters, please refer to the Final Rule Fact Sheet or the biotechnology regulation.

EPA's Review Process

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.

Any amount of a live genetically modified microorganism subject to TSCA reporting requirements that is transported to or from a site is unlikely to be eligible for a Tier I exemption. Anyone intending to ship such a microorganism off-site will likely need to submit either a Tier II exemption notice or an MCAN. In order to qualify for a Tier I exemption, the regulations at 40 CFR 725.424 specify that the manufacturer must certify that they meet all of the physical containment and control technologies enumerated in 40 CFR 725.422 for "any facility in which the microorganism is to be used." It is unlikely that off-site transportation of live genetically modified microorganisms could be accomplished under the physical containment and control restrictions required to qualify for the Tier I exemption.

TSCA Biotech Notifications Received to Date

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.

 


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