Venter Institute-Led Policy Group Publishes Report on Challenges and Options for Oversight of Organisms Engineered Using Synthetic Biology Technologies

ROCKVILLE, Md. and SAN DIEGO, May 28, 2014 /PRNewswire/ -- Policy researchers from the J. Craig Venter Institute (JCVI), the University of Virginia, and EMBO today released a report detailing the challenges faced by regulators with the increased use of more sophisticated synthetic biology technologies to engineer plants and microbes and some options for dealing with these challenges.

The authors conclude that while the United States governmental agencies tasked with oversight of 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 including: the advent of newer plant engineering technologies that are outside the authority of some agencies, and increased use of more complex engineered microbes that could overwhelm regulators both from a science and safety review and increasing cost perspective.

Genetic engineering to make relatively minor manipulations of small numbers of genes in plants, microbes, and animals has been utilized in science and biotechnology to develop products since the 1980s. Three agencies are tasked with oversight of genetically engineered organisms—the US Department of Agriculture's Animal and Plant Health Inspection Service (APHIS), the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA). Through the years these agencies have successfully reviewed products for potential environmental, health and safety concerns, and have also issued regulations and industry guidelines.

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.

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 the following options for oversight. 

Genetically Engineered Plants
APHIS has reviewed engineered plants for the past 25 years. This authority is based on genetic engineering technology that uses plant pests or some component of plant pests. Synthetic biology is accelerating development and use of new genetically engineered plants that fall outside APHIS' purview and thus without regulatory review before potential use in the environment.  The authors outline the following options:

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

Genetically Engineered Microbes
Synthetic biology is enabling a larger number of increasingly more complex engineered microbes for commercial use, particularly those intended for use in the open environment. This influx may overwhelm the EPA's Biotechnology Program both from an expertise and funding perspective. The policy team outlined the following options for consideration to help alleviate any regulatory delays or deficiencies for microbial products:

1. If and when needed, provide additional funding for EPA's Biotechnology Program under TSCA and pursue efficiency measures to expedite reviews.
2. 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 report is funded by the United States Department of Energy Office of Biological and Environmental Research with additional support from the Sloan Foundation. Authors of the report are: Sarah R. Carter, Ph.D., JCVI; Michael Rodemeyer, J.D., University of Virginia, Michele S. Garfinkel, Ph.D., EMBO, Germany, Robert M. Friedman, Ph.D., JCVI. The full report can be downloaded here:   http://www.jcvi.org/cms/research/projects/synthetic-biology-and-the-us-biotechnology-regulatory-system/

About the J. Craig Venter Institute (JCVI)
The JCVI is a not-for-profit research institute in Rockville, MD and San Diego, CA dedicated to the advancement of the science of genomics; the understanding of its implications for society; and communication of those results to the scientific community, the public, and policymakers. Founded by J. Craig Venter, Ph.D., the JCVI is home to approximately 250 scientists and staff with expertise in human and evolutionary biology, genetics, bioinformatics/informatics, information technology, high-throughput DNA sequencing, genomic and environmental policy research, and public education in science and science policy. The legacy organizations of the JCVI are: The Institute for Genomic Research (TIGR), The Center for the Advancement of Genomics (TCAG), the Institute for Biological Energy Alternatives (IBEA), the Joint Technology Center (JTC), and the J. Craig Venter Science Foundation. The JCVI is a 501 (c)(3) organization. For additional information, please visit http://www.JCVI.org.

SOURCE J. Craig Venter Institute