Synthetic Biology Oversight Called Inadequate

Regulatory oversight of synthetic biology in the U.S. needs to be modernized to ensure the responsible development of promising new technologies, a report from the Woodrow Wilson International Center for Scholars concludes. Although existing laws are broad enough to allow federal agencies to assess the potential risks and benefits of products derived from synthetic biology, the regulatory infrastructure is not well suited to address the regulatory needs, the report says. Synthetic biology involves the use of biological engineering techniques to create organisms with novel or enhanced functionalities. Jurisdiction for these products is split across EPA, FDA, and the Department of Agriculture. This structure creates problems because some synthetic biology products fall within the jurisdiction of multiple agencies and others are not covered by any of them. “Competing and sometimes conflicting jurisdictional issues confound, if not frustrate, prompt and effective government oversight of synthetic biology,” the report notes. The authors provide a few case studies to illustrate the problems. For more on regulation of synthetic biology, see page 26.