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November 7, 2014

Article Explores TSCA Application To Synthetic Biology


The October 2014 issue of Industrial Biotechnology features the article Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act (TSCA), written by Lynn L. Bergeson, Of Counsel with the Biobased and Renewable Products Advocacy Group (BRAG®), Charles M. Auer, former Director of the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT), and Oscar Hernandez, former Director of the Risk Assessment Division (RAD) of EPA OPPT.

Synthetic Biology is delivering on its promise as an emerging scientific field providing society with effective new sustainable products in diverse areas including renewable energy, contamination remediation, and medical applications, among others. As is the case with any rapidly evolving technology, the pace of technological innovation challenges regulators' ability to identify and address adequately the substantial uncertainties they confront when discharging their legal obligations under controlling laws to ensure human and environmental safety. This article provides a brief description of Synthetic Biology, discusses the current domestic regulatory framework that governs the regulation of products of Synthetic Biology, and focuses narrowly on options and opportunities EPA, innovators in the area of Synthetic Biology, and the TSCA-regulated community at large may wish to consider to enhance TSCA's core adaptive capacity to identify and address potential health and environmental risk implications posed by the commercialization of products of Synthetic Biology.