Report details challenges faced by synthetic biological technologies
Researchers from the J. Craig Venter Institute (JCVI), the University of Virginia and EMBO developed the report with funding from the U.S. Department of Energy Office of Biological and Environmental Research and the Sloan Foundation. The authors concluded that while the agencies that oversee products derived from synthetic biology have the authority to address most environmental, health and safety concerns, there are some issues that could pose challenges to the regulators, Global Biodefense reports.
The researchers said the advent of newer plant engineering technologies outside the authority of some agencies and increased use of more complex engineered microbes could overwhelm regulators.
Synthetic biology, which is the newest generation of genetic engineering, allows for the construction and synthesis of whole genes and genomes for product development.
"Synthetic biology offers great promise for a new and improved generation of genetically engineered microbes, plants, and animals," Robert Friedman, the vice president for policy with JCVI, said, according to Global Biodefense. "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 researchers suggested options for improving the oversight of genetically engineered plants and microbes. They recommended that the Animal and Plant Health Inspection Service (APHIS) rely on a voluntary approach for genetically engineered plants not subject to review, apply existing laws to the most likely risks from new plant biotechnology and distribute rules under existing law to regulate engineered plants.
The authors also suggested that the U.S. provide additional funding to Environmental Protection Agency's (EPA) Biotechnology Program to pursue efficiency measures to expedite reviews of genetically engineered microbes and amend the Toxic Substances Control Act to strengthen the EPA's ability to regulate engineered microbes, Global Biodefense reports.