(Image via Shutterstock)
(Image via Shutterstock)

The synthetic biology product floodgates are opening, and U.S. environmental, health, and safety regulators are at risk of drowning.
That’s the general sentiment expressed in a report released this week by policy researchers at the J. Craig Venter Institute, the University of Virginia, and EMBO in Heidelberg. They detail how the increased use of more sophisticated synthetic biology technologies to engineer plants and microbes will present major challenges to government agencies including EPA, FDA, and USDA’s Animal and Plant Health Inspection Service that have oversight of syn-bio-derived products.
The report, Synthetic Biology and the U.S. Biotech Regulatory System: Challenges and Options, suggests that newer plant engineering technologies for products including bioenergy crops and biofuel-producing algae, for use in or grown directly in the environment could be outside the authority of some agencies.
Meanwhile, a report in the New York Times points out that synthetic biology-based ingredients are increasingly showing up in consumer products ranging from cosmetics to flavorings to scents. Environmental groups and consumer activists have already begun to “call for labeling that would disclose whether synthetic biology was used to make product ingredients,” the Times reports.
Increased use of more complex engineered microbes, could overwhelm regulators’ capabilities in terms of science, safety, and cost. The authors of the Venter Institute report write:

“Over the last five years breakthroughs and advances in the new field of synthetic biology—the newest generation of genetic engineering—are enabling construction and synthesis of whole genes and genomes opening even more new avenues for product development in many industries including new food and nutritional products, vaccines and pharmaceuticals, and biofuels.”


For instance, they explain, USDA’s authority to regulate genetically engineered plants is based on technology that uses plant pests or some component of plant pests. But because plants engineered with new synthetic biology technologies don’t fall into that category, they could be released into the environment without regulatory review.
Microbes are also being engineered for commercial use in the open environment with synthetic biology. The authors suggest, “This influx may overwhelm the EPA’s Biotechnology Program both from an expertise and funding perspective.”
Report author Robert Friedman of the Venter Institute said in a statement, “Synthetic biology offers great promise for a new and improved generation of genetically engineered microbes, plants, and animals. To achieve this promise, the public must be assured that the U.S. regulatory agencies are able to review these products as effectively as they have over the past two decades. Our report identifies several issues and options for policymakers to update the current U.S, regulatory system for biotechnology.”
Our first-ever Techonomy Bio event on June 17th in Mountain View, Calif., will explore the impact of synthetic biology, GMOs, and more.