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Filing a Biotechnology Submission

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Overview

Section 5 of the Toxic Substances Control Act (TSCA) requires the submission of certain information to EPA if a person wishes to commercialize an intergeneric microorganism, or to introduce such microorganisms into the environment for research purposes. 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.

Read EPA's final biotechnology regulation Microbial Products of Biotechnology; Final Regulation under the Toxic Substances Control Act; Final Rule.

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Learn how to file a Biotechnology Submission with EPA

Note: There is no required format for biotech submissions in the e-PMN software.   In the “Forms” screen of the e-PMN program, choose to create a new form and then select "Biotechnology." You will be required to enter contact information regarding the submitting company and the technical contact. There are five biotechnology submission choices: MCANs, TERAs, Tier I and Tier II exemptions, and Biotechnology Test Market Exemption Applications (TMEAs). After selecting a submission type, you can enter the submission information in a cover letter and as attachments.

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. Anyone intending to ship such a microorganism off-site will likely need to submit either a Tier II exemption notice or an MCAN.

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.

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EPA's Review Process

Upon receipt of the submission, EPA 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.

Read more about the kinds of evaluations EPA makes as part of the new chemicals review process.

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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 those submissions received under the biotechnology regulation, and covers FY 1998 to present. 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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