Abstract
Under the Toxic Substances Control Act (TSCA), intergeneric microorganisms intended for commercial purposes are reviewed for their safety. TSCA-subject microorganisms include those in several use categories such as fermentation applications for specialty chemical production (detergent enzymes, etc), biofertilizers, ore mining, oil recovery, biomass conversion, and bioremediation. Such intergeneric microorganisms are subject to Premanufacture Notification (PMN) review prior to commercialization, and voluntary PMNs are requested if the microorganisms will be used in field tests to examine issues such as efficacy prior to full commercialization. In either case, the US Environmental Protection Agency’s (USEPA) Office of Pollution Prevention and Toxics (OPPT) reviews the PMN and legally-binding conditions on the microorganism’s production, and use are negotiated between the proponent and OPPT in order to address any risk concerns identified in the USEPA’s review. In the case of field tests proposed for Pseudomonas fluorescens Strain HK44 (pUTK21), the decision took the form of a Consent Order under Section 5(e) of TSCA.
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Sayre, P. (1997). Risk Assessment for a Recombinant Biosensor. In: Sayler, G.S., Sanseverino, J., Davis, K.L. (eds) Biotechnology in the Sustainable Environment. Environmental Science Research, vol 54. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-5395-3_25
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DOI: https://doi.org/10.1007/978-1-4615-5395-3_25
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