An official website of the United States government.

This is not the current EPA website. To navigate to the current EPA website, please go to This website is historical material reflecting the EPA website as it existed on January 19, 2021. This website is no longer updated and links to external websites and some internal pages may not work. More information »

TSCA Biotechnology Regulations

On other pages:

EPA’s New Chemicals Program conducts a premanufacture screening program for new microorganisms under section 5 of TSCA.  EPA considers intergeneric microorganisms to be those formed from organisms in different genera or those formed with synthetic DNA not from the same genus. In 1997, EPA published regulations that fully implement its premanufacture program for microorganisms under TSCA section 5.

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

In March 2020, EPA finalized a rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under TSCA. Manufacturers of new intergenetic Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens)  may now be eligible to undergo a streamlined review process under TSCA's new chemicals review program with reduced TSCA fees. Read the final rule. 

More information on TSCA biotechnology regulations and policies can be found on our Final Regulations and Policy-Related Resources page. This page includes links to these documents:

  • Microbial Products of Biotechnology: Summary of Regulations under TSCA
  • Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms
  • Final Risk Assessments in Support of the Final Regulation

To find additional information on TSCA biotechnology publications, search the EPA archive. SEARCH EPA ARCHIVE