Report on regulation of synbio in United States

[Jason Bobe]

FYI: a new report offers a detailed look and discussion around the adequacy of U.S. regulation of synbio products:

http://www.jcvi.org/cms/research/projects/synthetic-biology-and-the-us-biotechnology-regulatory-system/overview/

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The JCVI Policy Center Team, along with researchers at the University of Virginia and EMBO, examined how well the current U.S. regulatory system for products will handle the near-term introduction of organisms engineered using synthetic biology. In particular, the focus was on those organisms intended to be used or grown directly in the environment, outside of a contained facility.
The study concludes that the U.S. regulatory agen­cies have adequate legal authority to address most, but not all, potential environmental, health and safety con­cerns posed by these organisms. Such near-term products are likely to represent incremental changes rather than a marked departure from previous genetically engineered organisms. However, the study also identified two key challenges for the regulatory system, which are detailed in the report. First, USDA’s authority over genetically engineered plants depends on the use of an older engineering technique that is no longer necessary for many applications. The shift to synthetic biology and other newer genetic engineering techniques will leave many engineered plants without any premarket regulatory review. Second, the number and diversity of engineered microbes for commercial use will increase in the near future, challenging EPA’s resources, expertise, and perhaps authority to regulate them.

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Some consideration for DIY practitioners on page 41:

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"Many DIY biologists, including those working in community labs, such as Genspace in Brooklyn, NY (http://gens- pace.org/page/about), and BioCurious in the San Francisco Bay Area (http://biocurious.org/about/), explicitly pursue commercial applications for their engineered microbes, making much of the research in these settings subject to EPA oversight. Because these facilities practice and document basic biosafety procedures, their contained research is likely exempt from MCAN requirements based on safe-use exemptions. As would be the case for any other commercial endeavor, any environmental release of a microbe with commercial intent would require a TERA. A barrier to compliance for these groups, and particularly for DIY biologists practicing outside of a community lab, is knowledge of EPA procedures."

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Jason 

[Mega [Andreas Stuermer]]

As would be the case for any other commercial endeavor, any environmental release of a microbe with commercial intent would require a TERA?

 

I gotta dig in, that's interesting