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.