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TSCA Biotechnology Regulations

New Chemical Safety Law Enacted

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updates the Toxic Substances Control Act. Learn more about the new law, find summary information and read frequently asked questions.

On other pages:

To find additional information on TSCA biotechnology publications, search the EPA archive. Search EPA Archive

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)

Regulations under Development

September 5, 2012 -- EPA is proposing to add two microorganisms (specific strains of the fungus Trichoderma reesei and specific subspecies of the bacterium Bacillus amyloliquefaciens) to the list of 10 recipient microorganisms (40 CFR 725.420) that are eligible for exemptions from full chemical notification requirements under the Toxic Substances Control Act (TSCA).

Read the proposed rule (PDF).(13 pp, 290 K, About PDF)

Final Regulations and Policy-Related Resources

The Final Regulations and Policy-Related Resources 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