Preventing the Misuse of Gene Synthesis: Fostering Industry Self-Regulation, Backed Up with Targeted Government Policies, Is the Best Way to Capture the Benefits and Reduce the Risks of Synthetic Genomics

Article excerpt

During the past decade, a global industry has emerged based on synthetic genomics: the use of automated machines to construct genes and other long strands of DNA by stringing together chemical building blocks called nucleotides in any desired sequence. Some 50 companies--concentrated primarily in the United States, Germany, and China--synthesize gene-length segments of double-stranded DNA to order. Scientists in government, university, and pharmaceutical laboratories worldwide use these products to study fundamental cellular processes and to develop new vaccines and medicines, among other beneficial applications. But synthetic genomics presents a dual-use dilemma in that outlaw states or terrorist groups could potentially exploit synthetic DNA for harmful purposes. Of the biotechnologies that entail dual-use risks, gene synthesis has elicited the greatest concern because of its maturity, availability, and potential consequences.

Already, the ability to synthesize long strands of DNA and stitch them together into a genome, the blueprint of an organism, has enabled scientists to recreate infectious viruses from scratch in the laboratory. This feat was accomplished for poliovirus in 2002, the Spanish influenza virus in 2005, and the SARS virus in 2008. Some analysts worry that it will soon become technically feasible to synthesize the smallpox virus, a deadly scourge that was eradicated from nature in the late 1970s and currently exists only in a few highly secure repositories.

It is critical, then, to devise effective governance measures for synthetic genomics that permit the beneficial use of this powerful technology while minimizing, if not eliminating, the risks. Some analysts contend that the best approach is to have governments impose top-down, legally binding controls. Yet formal government regulations have a number of drawbacks. Not only are regulations time-consuming and cumbersome to develop and promulgate, but they are static and hard to modify in response to rapid technological change.

A better approach is to adopt a form of "soft" governance based on voluntary guidelines or industry best practices. This type of self-regulation, involving suppliers and perhaps consumers of synthetic DNA, can be reinforced by government policies that encourage responsible behavior. Although biosecurity measures for the gene-synthesis industry are being implemented in the United States and elsewhere, these activities are not well coordinated, and continued efforts will be needed on a national and international basis to fashion an effective global regime.

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A movement begins

The science behind commercial DNA synthesis may be cutting-edge, but ordering a synthetic gene over the Internet is quite straightforward. A customer--say, a university research scientist--goes to a supplier's Website, enters the sequence of the desired gene, and provides payment information, such as a credit card number. The company then synthesizes the requested strand of DNA. After verifying that the genetic sequence is correct, the company inserts it into a loop of DNA (called an expression vector) that can be cloned in bacteria to produce a large number of copies. Finally, the order is shipped to the customer by express mail.

The worry, of course, centers on what the recipient will do with the synthetic gene. Early on, a few suppliers recognized the dual-use nature of their product and began to develop voluntary biosecurity measures to reduce the risk that criminals or terrorists could order dangerous DNA sequences over the Internet. Blue Heron Biotechnology, founded in 2001 in Bothell, Washington, was one of the first to implement such measures. Initially, the company relied exclusively on screening customers to verify their bona fides, but in the wake of 9/11 and the anthrax letter attacks, it deployed a second line of defense: screening DNA synthesis orders.

As part of this effort, Blue Heron agreed to serve as a test-bed for a software package called Blackwatch, developed at Craic Computing in Seattle. …