By Corie Lok
Several gene-synthesis companies yesterday finalized a code of conduct that outlines how to screen orders for synthetic DNA that could be used for terrorist activities.
The code, which has been in the works from the International Association of Synthetic Biology (IASB) in Heidelberg, Germany, for a year and a half, reflects for the most part what has become common practice in gene-synthesis companies. Before filling orders, the firms compare the gene sequences with those from organisms on lists of pathogens, such as the US Centers for Disease Control and Prevention's select-agents list. Most companies then follow up 'hits' with human investigation of whether the match is valid and the purchaser is legitimate.
But how many companies will commit to this standard and whether this will end the conflict over how best to standardize these practices remains unclear.
Earlier this year, for example, two companies, DNA2.0 of Menlo Park, California, and Geneart of Regensburg, Germany, put forward their own code of conduct that includes only the automated screen (see 'Keeping genes out of terrorists' hands').
In Cambridge, Massachusetts, yesterday, representatives from a handful of US and European companies -- including Geneart but not DNA2.0 -- met to finalize the wording of the IASB code. The code states that hits from automated screens should be "assessed by a molecular biologist or similar subject matter expert". If the hit is deemed to be real and not a false positive, the order should be filled only when people have verified the legitimacy of the customer.
Some of the debate at the meeting centred on whether companies should try to determine the function of the requested genes, helping to clarify the level of risk. The standard leaves it open to companies to decide whether they would do this.
"Everyone's struggling with this issue," says Edward You of the FBI's Weapons of Mass Destruction Directorate. "It's not something you can solve in a meeting in a hotel conference room. If they ever come to a conclusion, that'd be great, because that makes my job easier and it makes it easier for the [gene-synthesis] companies to make the right judgement call."
"The next thing we will do is to reach out to everyone in the industry with this standard and invite them to join it," says Stephen Maurer, a lawyer and expert in public policy at the University of California, Berkeley, who helped to formulate the code. "And in the nature of standards wars, if enough people do that, the war will be over."
Markus Fischer of Entelechon in Regensburg, Germany, who was the chief architect of the IASB code, says that his company will sign up to the code. The other four companies that make up the IASB have pledged to adopt it as well.
But it's uncertain whether the rest of the industry will join them. The Synthetic Biology Industry Association in Irvine, California, is supportive of the new standard, but it is up to the individual companies whether they adopt it, says Joseph Kittle, chairman of the association.
Representatives from other companies were reticent at the meeting about their plans for selecting a standard. "We are evaluating this to see how this will fit with our processes," says Frank Notka, research and development manager at Geneart.
DNA2.0 declined to comment directly on the new standard, although the company did say that it valued "the efforts of organizations such as the IASB" to help forge biosecurity policy.
John Mulligan, chief scientific officer of Blue Heron Biotechnology in Bothell, Washington, says that his company is also assessing the code. Both Geneart and Blue Heron say that their current screening practices don't differ much from what's outlined in the IASB code.
"The issue of getting agreement between competing companies isn't a purely technical issue," says Mulligan. "It is hard to get competing companies to agree on anything. It doesn't surprise me that we aren't going to solve this today in this room, but we are moving towards a consistent solution. We might not all sign the same document, but it's going to come to the same thing."
US government officials at the meeting said they were pleased that the industry had taken the initiative to come up with its own standards. "Having a single code of conduct will help persuade other governments and companies to follow the same approach," says Robert Mikulak, director of chemical and biological weapons threat reduction at the US Department of State.
The US government will be releasing draft guidelines for voluntary synthetic DNA screening by the end of the year, says Mikulak. Although there are some differences in the details, the IASB code of conduct is similar to the forthcoming government guidelines, he adds.