Securing Synthetic Biology

​J. CRAIG VENTER, who in 2000 led the complete sequencing of the human genome, made news again in 2010 when his team of researchers manufactured bacteria DNA and used it to take control of a cell. Whether Venter created “synthetic life” is a matter of debate, but the project highlights the growing capabilities of synthetic biology.

As with any technology, synthetic biology promises great advances but threatens nefarious dual uses. In the past decade, scientists have mapped—and, in some cases, produced—the genomes for diseases, including polio and the flu strain that killed an estimated 50 million people in 1918.

In 2006, journalists with Great Britain’s Guardian newspaper researched the genome for the smallpox virus, devised strains with slight alterations that would render them inert, and ordered them from a gene sequencing firm by mail. They were manufactured and shipped to a post office box for around £40, about $65.

That exercise revealed a significant vulnerability and led to aggressive self-regulatory measures in the synthetic biology industry. It also spurred the formation of robust public-private partnerships among industry, academia, and law enforcement that continue to grow as technology both advances and becomes accessible outside the laboratory, Supervisory Special Agent Edward You of the FBI’s Weapons of Mass Destruction (WMD) Directorate, tells Security Management.

The International Association Synthetic Biology (IASB), a consortium of synthetic biology firms headquartered in Heidelberg, Germany, adopted the Code of Conduct for Best Practices in Gene Synthesis in 2009 to limit the risks posed by acquisition of DNA strands that could be used to construct dangerous pathogens, including dual-use substances. The Code of Conduct calls for members to assess the risk posed by each sequence manufactured, including vetting of sequencing data against sector databases and evaluation against national laws governing manufacture and distribution. Suspicious orders are referred to as “hits.”

Per the IASB policy, vendors must also vet potential buyers and the nature of the orders themselves. They are required to collect buyers’ personal data, including address, institution, telephone number, and e-mail address. Shipment to post office boxes and residential addresses is forbidden. Records of all substance screening “hits” as well as suspicious inquiries and any approved sales must be kept for eight years. IASB is also examining the possibility of a certification or labeling regime for the code, says organization spokesman Peer Stähler.

The Code of Conduct also calls for cooperation with designated government authorities, which in the United States means the FBI. You explains that an agent in each of the FBI’s 56 field offices is designated as a WMD coordinator and the point-of-contact for synthetic biology firms in that area. Firms coordinate with field offices to report and collaboratively vet suspicious orders.

In October of last year, the Department of Health and Human Services released voluntary federal guidelines for U.S. synthetic biology providers. The guidelines, which were similar to the IASB’s, formalized the FBI’s WMD coordinators as the official point-of-contact for U.S. providers who encounter suspicious orders. Internationally, however, there isn’t an equivalent process, and the FBI is currently working with international partners to create one, says You.

Despite the precautions, You emphasizes that there is no identified threat of terrorism related to synthetic biology. He says he knows of no cases in which suspicious order reports resulted in criminal investigations, but he notes that in one case, a foreign order raised concerns and export-regulation questions. The company contacted its local FBI WMD coordinator. That got FBI headquarters involved; the FBI then reached out to the Department of Commerce for the precise export regulations, which the agency then passed on to the company. “In this instance, the FBI acted solely as a resource for industry,” You says.

While the capability to manufacture sophisticated genetic strains remains within corporate laboratories and academia, the science has attracted interest among hobbyists, sometimes referred to as bio-hackers or gene hackers, who often work in their homes using commercially available equipment. The FBI has engaged the hobbyist community, You says, and is further reaching out to the next generation of researchers through the International Genetically Engineered Machine competition, (iGEM) an international synthetic biology competition for college undergraduates in which participants try to impart new properties and functions to organisms like yeast and bacteria.

In 2009, iGEM attracted more than 1,200 competitors from roughly 100 schools in 26 countries. The FBI attended, conducting a workshop on responsible research. This past November’s annual iGEM Jamboree, hosted by the Massachusetts Institute of Technology and sponsored by the FBI, prominently featured biosecurity issues.

You also stresses that the FBI hopes that communications go both ways. “The goal is to establish partnerships between law enforcement and the research community,” he says, “so that research communities can advise us on some of the ‘over the horizon’ security issues.”