Three policy analysts, two from the J. Craig Venter Institute (JCVI), the other from the University of Virginia, said the Bioeconomy Blueprint should address the challenge posed by new technologies such as synthetic biology considering the pace of technological change post the 1986 Coordinated Framework for the Regulation of Biotechnology. The three are investigators on a Department of Energy-funded study on the topic, with a full report expected in late 2012.
They envision another assessment of the Framework along the lines of reviews in 2001 by OSTP and the White House Council on Environmental Quality. “While there are strong arguments for maintaining the basic structure of the Framework, there will be a need to review regulatory authorities to meet the challenges of new technologies, including synthetic biology,” wrote Robert Friedman, Ph.D., JCVI’s director for California and leader of its policy group; JCVI policy analyst Sarah R. Carter, Ph.D.; and policy analyst Michael Rodemeyer from University of Virginia.
“Such a reassessment inevitably involves making difficult but extremely important judgments about striking the appropriate balance between regulation intended to prevent harm to public health and the environment and the desire to bring beneficial and safe products to market,” the three added.
Synthetic biology was among two biotechnology research priorities that Life Technologies president and COO Mark Stevenson urged the administration to identify; the other was genomics and public health. To advance synthetic biology, Stevenson suggested a cross-agency, coordinated research agenda in consultation with the private sector, with government supporting increased computational abilities; naming conventions aimed at forming a metagenomic catalogue of tools; identification and characterization of novel hosts and properties; and development, validation, and categorization of tools for scaled DNA construction and engineering.
As for genomics, Stevenson recommended two broad applications aimed at addressing the impact of microbes on human health and disease: Use of next-generation sequencing for food safety and epidemiological outbreaks and validation and standardization of instruments and methods.
Stevenson added that the Obama administration must also remove bioeconomy barriers by developing a regulatory pathway for next-gen sequencing, relying on manufacturers’ quality systems to keep nonconforming products from the market. It should also revise the draft FDA guidance concerning the labeling of in vitro diagnostic products marked research use only and investigational use only to address industry concerns that the proposed rules would, if adopted, disrupt the operations of clinical molecular labs.