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Policy specialists from the J. Craig Venter Institute (JCVI), the University of Virginia, and EMBO released a report that details the challenges faced by regulators with the increased use of more sophisticated synthetic biology techniques to engineer plants and microbes along with some options for dealing with these challenges.
The authors conclude that while the U.S. governmental agencies charged with overseeing products derived through synthetic biology have adequate legal jurisdiction to address most, but not all, environmental, health, and safety concerns, several key issues could challenge these agencies. These include the introduction of newer plant engineering technologies that are outside the authority of some agencies and the increased use of more complex engineered microbes that could overwhelm regulators both from a science and safety review and increasing cost perspective.
Since the 1980s three U.S. agencies are tasked with oversight of genetically engineered organisms—the Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the EPA, and the FDA. Over the last five years advances in the emerging synthetic biology field are enabling construction and synthesis of whole genes and...