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October 27, 2015

Lynn L. Bergeson Quoted in BNA Daily Environment Report Article “Uncertain Regulatory Path Costs Biotech Companies”

Bergeson & Campbell, P.C.

Lynn L. Bergeson was quoted in the October 15, 2015, BNA Daily Environment Report article “Uncertain Regulatory Path Costs Biotech Companies” about the recent Wilson Center report “The DNA of the U.S. Regulatory System: Are We Getting it Right for Synthetic Biology?”:

Getting regulatory approval for products made with synthetic biology techniques is a daunting process, Lynn Bergeson, managing partner of Bergeson & Campbell P.C., and co-author of the report, said during the Woodrow Wilson Center’s forum.

“It’s not clear what door do you knock on first,” she said. The various offices in a particular agency may not realize “who all has a bite at the apple” within their own agency, let alone the federal government, Bergeson said.

The length of time it can take companies and federal agencies to figure out which statute or statutes will apply to a technology and which agencies have jurisdiction over it causes significant anxiety for a technology’s financial backers, she said.

“Uncertainty is expensive. Without a reliably defined regulatory assessment pathway, innovation is discouraged,” said the report, which provides case studies to illustrate problems companies have encountered bringing products to market.

“We wanted to make this very practical and granular,” Bergeson said, explaining the reasoning behind the authors’ selection of case studies. The specific products discussed in the report include:

  • a mosquito that has been genetically engineered to mix with “wild,” or natural mosquitoes and through breeding reduce the population of mosquitoes carrying yellow fever, dengue fever and other human diseases;
  • a hormone produced through genetically engineered e. coli that stimulates female insects to overproduce pheromones that, in turn, are used to trap male insects;
  • a genetically engineered microorganism that can help miners extract copper while reducing energy use and the release of toxic metals in mine tailings; and
  • a cosmetic ingredient generated through genetically engineered yeast to reduce the use of shark liver oil to obtain the same chemical, thereby protecting sharks that the U.S. Fish and Wildlife Service has listed as endangered or threatened.

The problems highlighted in the report as companies and regulatory agencies tried to figure out who and which law had oversight are not designed to point fingers, Bergeson said.

“We are sympathetic to inflexible statutory constructs that necessitate putting square pegs in round holes,” she said.

The problems highlighted in the report are, however, intended to spur all interested parties to bring concerns and opportunities to federal agencies’ attention as they update the coordinated biotech framework, she said.

Asked by an audience member whether occupational health concerns, such as whether the engineered mosquitoes could pose a blood borne pathogen risk to workers, were addressed in the report, Bergeson said no. “We simply didn’t focus on it here.”