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  1. Home
  2. Regulation of Biotechnology under TSCA and FIFRA

Filing a Biotechnology Submission under TSCA

On this page:

  • Overview
  • Learn how to file a biotechnology submission with EPA
  • EPA’s review process
  • Related information

On other pages:

  • TSCA biotechnology program overview
  • TSCA biotechnology regulations 
  • TSCA biotechnology notifications status 

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)

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:

  • Read the TSCA biotechnology regulation (PDF). (49 pp, 431 K, About PDF)
  • Guidance Documents for Filing a Biotechnology Submission under TSCA.
  • Read further TSCA biotechnology regulatory and policy-related resources.
  • Learn how to electronically submit the biotechnology submission.

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

  • TSCA biotech notifications, fiscal year 1998 to present

Regulation of Biotechnology under TSCA and FIFRA

  • Overview of Plant-Incorporated Protectants
  • Overview of Emerging Mosquito Control Technologies
  • Overview of GMO Foods and the Feed Your Mind Initiative
  • Overview of Biotechnology under TSCA
  • Introduction to Biotechnology Regulation for Pesticides
  • Regulation of Genetically Engineered Microorganisms Under FIFRA, FFDCA and TSCA
Contact Us About the Regulation of Biotechnology under TSCA and FIFRA
Contact Us to ask a question, provide feedback, or report a problem.
Last updated on September 25, 2024
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