J. Craig Venter Institute and University of California San Diego Release New Report: "Policy and Regulatory Issues for Gene Drives in Insects," to Aid Scientists, Regulators and Others in Approaches to Safely Advance this Promising Area of Science

LA JOLLA, Calif., Aug. 2, 2016 /PRNewswire-USNewswire/ -- The J. Craig Venter Institute (JCVI) Policy Group and researchers at the University of California San Diego (UC San Diego), today released a new report titled, "Policy and Regulatory Issues for Gene Drives in Insects". The report outlines specific suggestions for researchers and research funders, United States regulators and policymakers, and international organizations, that could help advance this promising new scientific approach for combatting insect borne human disease and insect agricultural pests while ensuring environmental safety and societal issues are addressed.

University of California scientists have been at the forefront of developing gene editing technologies to quickly "drive" a desired trait throughout a population of insects. The hope is that the method could be used to engineer populations of insects in the wild, with the goal of reducing mosquito-borne diseases such as malaria or dengue fever, or controlling agricultural pests, such as those that transmit citrus greening disease. Many benefits are clear if these research efforts are successful, but several challenges must first be overcome.

In January 2016, Robert Friedman of JCVI's Policy Group and Ethan Bier, UC San Diego, convened a workshop that brought together leading researchers working to apply gene drive technologies to insects with federal regulators, ecologists, ethicists, and environmental policy analysts. Workshop participants were given the task to identify a path, if possible, to safely move gene drive insects from the laboratory to field trials, and if appropriate, to eventual deployment.

The participants identified and discussed the key challenges that scientists and decision makers will face as researchers develop gene drive insects intended for environmental release, and identified a series of "action items" to help address these challenges and hurdles.

Action items for the research community include a series of guidance documents about best practices to be followed at each stage of development, including updating existing guidance developed by professional societies to address previous generations of engineered insects.  Foremost among these is guidance to help product developers to engage and work with communities when pursuing field testing of these new approaches to control insect-borne disease and agricultural pests. Researchers and research funders alike were also encouraged to pursue new and varied gene drive designs so that products could be better tuned to the needs of specific applications.

Participants urged the relevant Federal agencies to update their guidance to product developers, and to clarify the relative roles of the Food and Drug Administration, U.S. Department of Agriculture, and Environmental Protection Agency for regulating genetically engineered insects. Participants also suggested that the U.S. Government establish a single office or point of contact to help guide developers to the appropriate Federal agency, as other countries have done. 

"The workshop offered a unique opportunity for dialogue between the developers of gene-drive insects and the regulatory and policy community," JCVI's Sarah Carter and Robert Friedman, authors of the report, said of the two-day meeting.  "The technology developers gained a better understanding of what they need to do to advance the technology from the laboratory and the policy community came away with a more nuanced view of the alternative designs that are possible." 

"A 'single door' that a researcher such as myself could use to better understand how to navigate the biotechnology system would be of enormous help to technology developers," said UC San Diego's Ethan Bier, who along with UC Irvine's Tony James, were the first to demonstrate how gene drives might be used to control malaria.

Although much of the research related to gene drive insects is and will take place in the U.S. and other developed countries, many of the products will have applications in the developing world. The workshop participants urged the World Health Organization (WHO) in particular to play the leading role to help developing countries build the regulatory capacity to oversee this next generation of engineered insects to help control devastating insect borne diseases. The WHO was also urged to update its guidance documents on field testing genetically engineered mosquitoes.

To download a copy of the report, go to http://www.jcvi.org/cms/research/groups/policy-center/.

Support for the workshop was provided by the Legler Benbough Foundation; UC San Diego, Office of the Chancellor; and the J. Craig Venter Institute.

About J. Craig Venter Institute
The JCVI is a not-for-profit research institute in Rockville, MD and La Jolla, 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 200 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 JCVI is a 501 (c)(3) organization. For additional information, please visit http://www.JCVI.org.

About UC San Diego
At the University of California San Diego, we constantly push boundaries and challenge expectations. Established in 1960, UC San Diego has been shaped by exceptional scholars who aren't afraid to take risks and redefine conventional wisdom. Today, as one of the top 15 research universities in the world, we are driving innovation and change to advance society, propel economic growth and make our world a better place. Learn more at www.ucsd.edu.

SOURCE J. Craig Venter Institute

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