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Filing a Biotechnology Submission under TSCA

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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
  • 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 of Microbial Products of Biotechnology under the Toxic Substances Control Act (PDF).49 pp, 431 K, About PDF)

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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. View the sample header sheet, entitled “EPA Biotech Form.” 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.

Access the e-PMN software.

Here are further resources on preparing a biotech submission under TSCA:

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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.

Related Information

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