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 genomes. As a result, new avenues for product development in many industries, including new food and nutritional products, vaccines and pharmaceuticals, and biofuels, are being opened.

With these advances in mind, the JCVI-led team examined how well APHIS, EPA, and FDA will be able to review the potential rapid increase of new plants and microbes developed using synthetic biology. They found areas of concern and offered options for oversight.

Regarding genetically engineered plants, the teams outlined the following options:

  • Maintain existing regulatory system and rely on a voluntary approach for those genetically engineered plants not subject to review.
  • Identify the most likely risks from newer plant biotechnology and apply existing laws that would best mitigate them.
  • Give APHIS additional authority to review and regulate genetically engineered plants.
  • Distribute rules under the Federal Insecticide, Fungicide and Rodenticide Act or the Toxic Substances Control Act (TSCA) for EPA to regulate engineered plants.

In looking at genetically engineered microbes, the JCRI-led group put forth the following options for consideration to help alleviate any regulatory delays or deficiencies for microbial products:

  • If and when needed, provide additional funding for EPA’s biotechnology program under TSCA and pursue efficiency measures to expedite reviews.
  • Amend TSCA to strengthen EPA’s ability to regulate engineered microbes.

“Synthetic biology offers great promise for a new and improved generation of genetically engineered microbes, plants, and animals,” said Robert Friedman, Ph.D., JCVI’s Vice President for Policy. “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.”

The full report can be downloaded here

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