J. Craig Venter Institute Policy Group Releases New Report: “DNA Synthesis and Biosecurity: Lessons Learned and Options for the Future”

(LA JOLLA, CA)—October 29, 2015—The J. Craig Venter Institute (JCVI) policy group today released a new report titled, “DNA Synthesis and Biosecurity: Lessons Learned and Options for the Future,” which reviews how well the Department of Health and Human Services guidance for synthetic biology providers has worked since it was issued in 2010.

Synthetic biology promises great scientific advances, but it also has the potential to pose unique biosecurity threats. It now is easier than ever to synthesize very long pieces of DNA from chemicals, potentially enabling a bioterrorist to build a toxin gene or an entire pathogenic virus. To guard against this possibility, the Department of Health and Human Services released its “Screening Framework Guidance for Providers of Synthetic Double-stranded DNA” in 2010, which called on providers of double-stranded DNA (dsDNA) to screen both customers and the DNA sequences ordered by those customers for potential biosecurity concerns.

The JCVI report, authored by Sarah R. Carter and Robert M. Friedman, addresses how well the Guidance has worked during its first five years and seeks to understand if changes to the Guidance are needed to keep pace with anticipated developments in the field of DNA synthesis over the next five years. In preparing this report, Carter and Friedman had numerous conversations with industry representatives, stakeholders, and policy makers, which culminated in a workshop held on April 28, 2015, in Washington, D.C.

The JCVI team concludes that the Guidance has been reasonably successful in its first five years with a large majority of the industry in voluntary compliance. In particular, the International Gene Synthesis Consortium (IGSC), which represents approximately 80% of the dsDNA synthesis industry, has outlined rigorous screening measures that are followed by its seven member companies. Many, but not all, other companies and non-profit dsDNA providers also follow the Guidance. Companies report that the administrative burden for voluntary compliance with the Guidance is substantial; we estimate, based on reports from the IGSC, that sequence screening and follow-up on pathogenic and potentially pathogenic sequences accounts for 1.5–3% of total costs. As the price of DNA synthesis continues to go down, this percentage is likely to increase.

According to Carter and Friedman, “Over the next five years, it will become more expensive for companies to adhere to the Guidance and thus, in our view, more challenging for U.S. policy makers to maintain a high level of biosecurity screening. Declining costs for dsDNA synthesis and competition from international dsDNA providers (that might not practice biosecurity screening) will make following the Guidance increasingly burdensome for U.S. companies. Furthermore, decentralized methods of obtaining dsDNA that are not addressed by the current Guidance may become more common. Commercially available chemical kits have simplified the assembly of gene-length dsDNA from short, single-stranded DNA (“oligos”). Also, the recent introduction of benchtop DNA synthesizers capable of making dsDNA may shift some fraction of the market to in-house assembly.”

The team identified two options that policy makers could pursue to strengthen the Guidance over the next five years:

1. Require federal grantees and contractors to purchase dsDNA only from companies that comply with the Guidance.
2. Provide a curated database of “sequences of concern” for dsDNA providers to use for screening.

Friedman and Carter also recommend consideration of ways in which the Guidance could be expanded to address oligos and benchtop synthesizers capable of making dsDNA.

To download a copy of the report, go to http://www.weizhongli-lab.org/policy-center​.

The report was funded by a grant from the Alfred P. Sloan Foundation http://www.sloan.org/.  

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.weizhongli-lab.org.

JCVI Media contact: Heather Kowalski, [email protected]
JCVI Policy group contact: Sarah Carter, [email protected]