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November 11, 2014
Enhancing Oversight of Synthetic Biology under TSCA to Promote Sustainable Commercial Development

Article Featured in Industrial Biotechnology

Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®) and Of Counsel with the Biobased and Renewable Products Advocacy Group (BRAG®), Charles M. Auer of Charles Auer & Associates, LLC, and Oscar Hernandez, Ph.D. of Oscar Hernandez & Associates, LLC, have published "Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act" in the October 2014 issue of Industrial Biotechnology, the journal of biobased innovation to drive the global bioeconomy. In the article, the authors propose options and opportunities the U.S. Environmental Protection Agency (EPA), innovators in the area of synthetic biology, and the Toxic Substances Control Act (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:

Recognizing that comprehensive TSCA legislative reform is still likely years away, stakeholders may be more successful in optimizing TSCA's inherent flexibility as an adaptive governance tool to foster the sustainable commercial development of synthetic biology. The collaborative pursuit of several suggested options now could facilitate the continued thoughtful and prudent development of synthetic biology by increasing public awareness, fostering a better understanding of this important emerging technology, ensuring that the EPA possesses the understanding it needs to discharge its responsibilities, and working to build a stronger collaborative environment among stakeholders and the EPA.

The article concludes with a number of specific points for consideration based upon the authors' experience working with industry clients as well as their understanding of EPA's needs and expectations. They emphasize that "ecause synthetic biology applications achieving commercialization are concentrated in the biofuels and biobased chemicals production areas," it is critically important that professionals in these sectors "create opportunities to brief EPA scientists and regulators on innovations and technological developments."

Lynn L. Bergeson is Managing Partner of B&C, a law firm focusing on conventional, nano, and biobased chemical, pesticide, and other specialty chemical product approval and regulation, environmental, health, and safety law, chemical product litigation, and associated business issues. Ms. Bergeson is also Of Counsel with BRAG, a consortium providing a platform for organizations engaged in biobased chemistries to identify regulatory barriers for their unique products and to work collectively to address them.

Charles M. Auer is the President of Charles Auer & Associates, LLC, and is an affiliate with B&C. Mr. Auer retired in January 2009 as the Director of the EPA Office of Pollution Prevention and Toxics (OPPT) where he was responsible for chemical assessment and management issues under TSCA, pollution prevention, and Design for the Environment under the Pollution Prevention Act.

Oscar Hernandez, Ph.D., Oscar Hernandez & Associates, LLC, retired as Director of the Risk Assessment Division (RAD) in EPA's OPPT in April 2013 after a 28-year career at EPA that focused on chemical assessment and management issues under TSCA.

Related articles authored by B&C and BRAG professionals include "Promoting Renewable Chemicals," The Environmental Forum, January/February 2014; "The Regulation of Renewable Chemicals under the Toxic Substance Control Act (TSCA)," Environmental Quality Management, Fall 2013; and "Why BRAG Before You Go to Market? The Biobased and Renewable Products Advocacy Group (BRAG) Helps Companies Commercialize Their Products," Industrial Biotechnology, August 2013.


 
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