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TSCA Biotechnology Regulations
The regulation under which the TSCA Biotechnology Program functions is titled "Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act," promulgated in the Federal Register on April 11, 1997. EPA developed this rule under TSCA section 5, which authorizes the Agency to, among other things, review new chemicals before they are introduced into commerce. Under a 1986 intergovernmental policy statement, intergeneric microorganisms (microorganisms created to contain genetic material from organisms in more than one taxonomic genera) are considered new chemicals under TSCA section 5. EPA considers intergeneric microorganisms to be those formed from organisms in different genera or those formed with synthetic DNA not from the same genus. The biotechnology rule sets forth the manner in which the Agency will review and regulate the use of intergeneric microorganisms in commerce, or commercial research.
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 ten recipient microorganisms (40 CFR 725.420) that are eligible for exemptions from full chemical notification requirements under the Toxic Substances Control Act (TSCA). EPA will take comment on the proposal until November 5, 2012. Read the proposed rule.
Final Regulations and Policy
Related Documents
Fact Sheet for Biotechnology under TSCA or
PDF version of Fact Sheet for Biotechnology under TSCA (PDF) (2 pp, 17K, about PDF)Points to Consider When Submitting Information under the Final Biotechnology Rule (PDF) (71 pp, 1.3MB, about PDF)
Supplementary Documents (in support of the Final Rule)