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 TSCA section 5. Prior to 1997, EPA operated its biotechnology program in accordance with the 1986 Policy Statement that was part of the Federal Coordinated Framework for Regulation of Biotechnology (PDF) (123 pp, 7.7MB, about PDF).
On this site, you will find:
TSCA Biotechnology Regulations including information on the microorganisms subject to EPA's rules, reporting requirements and exemptions.
Filing a Biotechnology Submission with EPA -- If you submit a biotechnology submission for a microorganism ("biotech submission") to EPA, you are required to use the electronic-PMN ("e-PMN") software as described in 40 CFR 725.25 (PDF) (4 pp, 152K). Learn more.
TSCA Biotechnology Notifications filed to date.
Other EPA Biotechnology Activities administered by EPA's Office of Chemical Safety and Pollution Prevention.