The safety of early applications of synthetic biology may be adequately addressed by the existing regulatory framework for biotechnology, but, according to a report authored by Michael Rodemeyer of the University of Virginia, further advances in this emerging field are likely to create new challenges for government oversight. Synthetic biology promises major advances in areas such as biofuels, specialty chemicals, agriculture, and drug products.

In the report, Rodemeyer examines the benefits and drawbacks of using the existing U.S. regulatory framework for biotechnology to cover the new products and processes enabled by synthetic biology. Rodemeyer conjectures that initial synthetic biology products will be relatively simple modifications of current technology, and can be addressed by existing biotechnology regulations with only modest revisions.

However, as the technology develops, regulatory agencies will face challenges in assessing potential risks and the adequacy of controls, especially if complex synthetic microorganisms are released into the environment. Today’s risk assessment practices and laws are simply not designed to handle 21st century technological services.

Before synthetic biology matures, congress and policymakers should consider how to rationalize and modernize the regulation of new converging technologies, instead of attempting to shoehorn each new area of technological development into laws previously written for a different set of issues and potential risks.

In my opinion, policymakers, industry, and other key stakeholders should start a discussion now on the basic question of whether existing regulations will work with advanced synthetic biology, and if not, what changes may be needed to ensure safe development and application of the science.

For Rodemeyer’s report and more information about synthetic biology, please visit http://www.synbioproject.org

View a previously written post by Mouli Cohen about biotechnology