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Report: Regulatory Authority Exists to Oversee Synthetic Biology, but Challenges Remain

NEW YORK (GenomeWeb) – The US government has the fundamental regulatory authorities it needs to oversee the rapidly growing field of synthetic biology, but some types of plant and microbial engineering pose challenges that will require policy responses, though not necessarily new regulations, according to a new federally funded report.

The three authors from the J. Craig Venter Institute, the University of Virginia, and the European Molecular Biology Organization pointed out in the report that the US Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency have already overseen genetically engineered organisms for years.

Ever since the first recombinant DNA-based products began hitting the market in the 1980s, these agencies have been reviewing genetically engineered products for environmental, health, and safety concerns, and have issued regulations and industry guidelines.

But the field has been growing swiftly with the emergence of synthetic biology. As GenomeWeb Daily News reported last year, the number of synthetic biology firms tripled between 2009 and 2013.

The types of tools available are also changing. It is now possible to construct and synthesize whole genes and genomes, which could lead to many new applications, such as vaccines, pharmaceuticals, food and nutritional products, and others, the authors noted. Still, they found that US agencies have the legal jurisdiction they require to address many of these products.

However, certain plant engineering technologies and the advancing complexity of microbial engineering pose certain problems, the authors stated, noting two key challenges. Some new plant technologies lie outside of the authority of these agencies, and the increased use of complex microbes could overwhelm regulators unprepared for the scientific and safety issues they present and may be expensive to oversee. The authors didn't propose that new regulations will necessarily be required, but they suggested a few policy options that regulators may consider, such as expanding authorities that are already in place.

The USDA's Animal and Plant Health Inspection Service (APHIS) has reviewed genetically engineered technology that uses plant pests, but now synthetic biology is generating plants that fall outside APHIS' purview, they wrote.

There are four possible courses the government could pursue here, according to the authors: maintain the current regulatory structure and use a voluntary system for the plants that are not subject to review; identify the most likely risks from these plants and apply any existing laws that might mitigate them; have Congress give APHIS additional authority to review and regulate genetically engineered plants; or use rules under either the Federal Insecticide, Fungicide, and Rodenticide Act or the Toxic Substances Control Act (TSCA), which would enable the EPA to regulate genetically engineered plants.

There also is a concern that the expected influx of genetically engineered microbes, particularly those used in the environment, could overwhelm the capabilities of the EPA's Biotechnology Program, in terms of funding and expertise, to keep pace. The authors suggested that the Biotechnology Program could receive increased funding to expedite its reviews, or that the TSCA could be amended to strengthen the agency's ability to regulate engineered microbes.

"Synthetic biology offers great promise for a new and improved generation of genetically engineered microbes, plants, and animals," JCVI Vice President for Policy Robert Friedman said in a statement. "To achieve this promise, the public must be assured that the US regulatory agencies are able to review these products as effectively as they have over the past two decades."

The report, "Synthetic Biology and the US Biotechnology Regulatory System: Challenges and Options," was funded by the US Department of Energy's Office of Biological and Environmental Research, along with support from the Alfred P. Sloan Foundation.

Like the US, the European Union and its member nations want to assess how well equipped they are to oversee synthetic biology technologies.

A recent Synthetic Biology ERA-NET (ERASynBio) project report advised that the current European regulatory framework is likely to be challenged by synthetic biology. That report highlighted the do-it-yourself biology area as one particular field in which researchers work outside of normal, regulated research environments as a unique challenge. The ERASynBio report's authors urged that any regulations in this and other new synthetic biology fields should provide for safety and security without stifling innovation or without over-regulation.