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October 26, 2015
Inside EPA Quotes Lynn L. Bergeson in article “TSCA Reform Legislation Could Smooth Path For New Biotechnologies”

The October 26, 2015, Inside EPA article, “TSCA Reform Legislation Could Smooth Path For New Biotechnologies,” included comments made by Lynn L. Bergeson at an event hosted by the Wilson Center’s Synthetic Biology Project (synbio).

Pending legislation in Congress to reform the 40-year-old Toxic Substances Control Act (TSCA) could make it easier for EPA to assess the potential risks of new technologies, such as synthetic biology, and review requests to undertake field research or commercialize new products, an industry attorney says.

While the legislation does not “expressly address any of the issues” with biotechnology, nanotechnology or new technologies specifically, “any legislative recast of TSCA will help with new technologies,” Lynn Bergeson, of the law firm Bergeson & Campbell said during an Oct. 15 event at the Wilson Center on Synthetic Biology (synbio).

“The big picture is if TSCA were to be reformed, there are greater opportunities for EPA to obtain information and make risk findings and determine that . . . existing chemicals are not meeting an established safety standard,” Bergeson said. “Because TSCA reform is mature, we are very hopeful it will emerge soon . . . and in whatever form it will expand the agency’s authority to review, assess and procure information to make safety findings, which I think we can all get behind and support.”

Bergeson, however, indicated that while she hopes to see TSCA reform, she believes that the existing statutory structure can handle new technologies like nanotechnology and biotech, but the regulatory underpinnings need modernization.

Bergeson and her colleagues have outlined five of these “urgently needed” regulatory changes in a new report, “The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?” They released the report at the event.

Among the report’s recommendations are “Developing a long-range, governmentwide strategy to assure that, going forward, the regulation of synthetic biology encourages innovation while timely identifying and addressing risks through a science-based, transparent process that encourages public confidence.”

Additionally, the report recommends more funding for EPA and other federal agencies to train and keep abreast of the growing number of new technology applications they are reviewing, with the addition of new technology stewards in all offices to coordinate between the agencies and offices; creation of centers of technological excellence to keep up with developments; routine briefings for agency staffs from industry and academic innovators and creation of an ongoing education process for federal decision makers and the public about synbio.

[…]Bergeson, in discussing possible changes to TSCA that could aid regulation of new technologies, pointed to a 2014 report from the J. Craig Venter Institute as one that provides suggestions of improvements that could be made to TSCA to further improve the oversight of biotechnologies.[…]


 
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