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July 31, 2015

Lynn L. Bergeson Quoted in BNA Daily Environment Report Article “Companies Invited to Help Develop Algae Guidance”

Bergeson & Campbell, P.C.

The July 31, 2015, Bloomberg BNA Daily Environment Report spoke with Lynn L. Bergeson regarding EPA’s plans to develop updated guidance for companies making chemicals with genetically engineered microorganisms under the Toxic Substances Control Act (TSCA).

“EPA’s posting of the synbio algae project is hugely important for the industrial biotechnology and synthetic biology communities,” Lynn  Bergeson, managing partner of Bergeson  & Campbell P.C., told Bloomberg BNA in an e-mail. Her law firm specializes in policies for emerging technologies used to make chemicals and pesticides.

”Bergeson said the significance of EPA’s announcement becomes clearer in the context of other relevant developments. First, on July 2, the Obama administration directed the EPA, the Food and Drug Administration and the Agriculture Department to update their Coordinated Framework for the Regulation of Biotechnology within the next 12 months(128 DEN A-3, 7/6/15).

This White House memo reflects the administration’s acknowledgement that the framework must be updated to reflect the explosion of new technologies addressed by the federal regulatory agencies and the lack, in some instances, of a coherent regulatory framework innovators and others can anticipate and follow in commercializing their products,  [Description: previous hit] Bergeson [Description: next hit]  said.

Complicating the picture, the EPA’s July 30 announcement said some biotech submitters have “little or no experience with new substance review,” which makes the agency’s s commitment to develop guidance all the more urgent, she said.

Second, EPA’s Points to Consider document plainly needs an update since its last revision almost two decades ago,  [Description: previous hit] Bergeson [Description: next hit]  said. “EPA’s acknowledgement, in writing, that this process is underway is significant.”

“For those of us assisting innovators with preparing MCANs and TERAs, we appreciate that the regulated community and academic research organizations have much to offer EPA with improving and updating the Points to Consider document,” she said.

“The sharp spike in MCAN submissions reflects the tremendous commercial activity in this area, and the need for more clarity, EPA staff, and EPA resources to manage the demand,” Bergeson said.

“Third, EPA’s stand-alone synbio algae project confirms what we have predicted, namely that most recent biotechnology submissions involve some aspect of synthetic biology and EPA expects many more down the road. The synbio project presumably will capture aspects unique to these applications and focus on algal technologies,” she said.

The upcoming meeting in September means there isn’t a lot of time to identify and prioritize issues in a way most helpful to assist the EPA’s much needed efforts, but the agency’s activities offer huge opportunities for innovators, Bergeson said.