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TSCA Biotechnology Regulations

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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