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Microbial Products of Biotechnology: Final Rule (62 FR 17910)
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. This rule was developed 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. 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.
Related Documents:
Final Rule Fact Sheet or
PDF version of Final Rule Fact Sheet (PDF) (2 pp, 17K, about PDF)Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act; Final Rule or
Microbial Products of Biotechnology; Final Regulation Under the Toxic Substances Control Act; Final Rule (PDF) (50 pp, 337K, 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)