[DIYbio] Report on regulation of synbio in United States

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.