Overview of Biotechnology under TSCA

Under the Toxic Substances Control Act (TSCA), EPA regulates the use of intergeneric microorganisms in commerce or commercial research. EPA considers intergeneric microorganisms to be those formed from organisms in different genera (genera is the plural of genus, which is a level in a taxonomic classification system based on the relatedness of organisms) or those microorganisms formed with synthetic DNA not from the same genus.

EPA believes that intergeneric microorganisms have a sufficiently high likelihood of expressing new traits or new combinations of traits to be termed "new" and warrant EPA review. The Office of Pollution Prevention and Toxics (OPPT) Biotechnology Program conducts a screening program for new microorganisms under section 5 of TSCA. In 1997, EPA published regulations that fully implement its premanufacture program for microorganisms under the OPPT New Chemicals Review Program.

In this site, you will find:

• TSCA Biotechnology Regulations
• Filing a Biotechnology Submission 
• Notifications Reviewed under Amended TSCA
• TSCA Biotechnology Notifications Status, FY 1998 to June 22, 2016

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