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Synthetic Gene Firms Get Ahead of Government on Security

NEW YORK (GenomeWeb News) – Synthetic biology companies and the US government appear to share many of the same ideas about measures that should be taken to keep potentially dangerous synthesized gene sequences out of the hands of bioterrorists.

A proposed guidance from the Department of Health and Human Services that outlines practices that companies in the gene synthesis business should follow is quite close to an effort started by some of the larger firms in the field to harmonize their practices, two members of the industry group told GenomeWeb Daily News in interviews last week.

John Mulligan, chairman and CSO of Blue Heron Biotechnology, and Damon Terrill, senior VP and General Counsel for Integrated DNA Technologies, said that the group of companies, the International Gene Synthesis Consortium, shares the concerns and most of the ideas proposed in a recent HHS guidance.

"The IGSC is relatively new, but each of these companies have been dealing with biosecurity for four to six years, and have had a series of interactions with the government," Terrill said of the consortium, which includes Blue Heron, IDT, Geneart, DNA2.0, and GenScript.

"Our strategy is to be proactive and to get people at the policy level thinking about the implications [of synthetic biology technologies] when they have lots of time… to think through what it's going to mean rather than trying to make decisions really fast," Mulligan explained, adding that he expects the field to develop at a fast pace and for synthetic biology tools to become more widely used and available.

"I see these federal guidelines as part of a multi-year process that we've been active and enthusiastic participants in," Mulligan added.

The fear is that someone could use synthetic genetic material to create a pathogen that would end up being used by bioterrorists.

Uncertainties about the various ways in which these technologies could be used, and who has access to them, have begun to make the US government uneasy.

"Compounding this uncertainty is the pace at which synthetic biology is evolving, the sheer amount of new information the field is producing, and the growing diversity and number of practitioners," according to a 2006 report from HHS' National Science Advisory Board for Biosecurity.

That report proposed that due to the biosecurity risks, synthetic biology should "be subject to institutional review and oversight," and that outreach and education strategies were needed to engage the relevant research communities.

The NSABB report also argued that government should keep up with advances in synthetic biology and their relevance to virulence and pathogens.

The new HHS guidance, called "Screening Frameworks Guidance for Synthetic Double-Stranded DNA Providers," currently is available for public comments.

It focuses on three major areas — screening potential customers, screening sequences, and follow-up screening practices to be used if any 'red flags' are raised — and makes a number of specific proposals about practices gene synthesis firms should consider adopting.

The report offers two main goals for providers: they should know who they are selling their products to, and they should know if the products they are selling pose any hazards to public health, agriculture, or security.

The report proposes a number of steps firms could take to ensure safety, such as following set protocols for taking orders and identifying any unusual characteristics about their customers. For example, companies would screen genetic sequences against a list of pathogens and toxins, and the government would need to be contacted with information in certain types of cases, among other guidelines.

The IGSC has developed five core practices that each of its member companies will use to promote security.

IDT's Terrill said that the HHS proposals and the IGSC harmonization efforts are "largely consistent" in their aims and "very similar" in the types of measures and practices they involve.

"The consortium began when GeneArt and DNA2.0 began working together to develop a screening database, but what grew out of that was a consortium of five companies that represent 80-plus percent of the gene synthesis industry," he explained.

What the IGSC has done is to establish five core practices that each company should follow to promote biosecurity practices:

• Every synthetic gene will be screened against a regulated database that the consortium will develop. The database also will be used to screen amino acid sequences

• Each potential customer for synthetic genes will be screened and must be cleared for delivery, in accordance with national guidelines

• Screening, customer, and order records will be kept for at least eight years

• IGSC companies will have the right to refuse any order and may notify authorities of problematic orders, and they may coordinate with intelligence and law enforcement agencies.

• The members will comply with all applicable laws and regulations related to the synthesis, possession, transport, and exporting and importing of gene synthesis products.

Terrill explained that the IGSC did not develop this list of self-regulations in order to "avoid formal regulations. Our goal isn't to preclude regulations but to try out one regulatory regime on a voluntary basis and see how well that works. I think there is a general feeling that over time it'll move into a more formal regulatory regime, and we're not opposed to that," he said.

One proposal in the HHS guidance that differs from the IGSC effort, Terrill said, is a specific rule that would have companies break up sequences into under 200 base-pair fragments.

"We think that what we're doing is equivalent, or even more stringent, but we'll certainly test this," he said.

The IGSC does not currently see its harmonization efforts or the HHS proposals, as they stand so far, as having any effect on costs to firms or their customers, Terrill and Mulligan said.

Currently, Terrill said, there is a "very low probability that synthetic genes could be used to commit an act of bioterrorism, but the events of September 2001 caused the government to focus on low-probability risks that nevertheless would be very high-impact were they to be realized."

"We want regulations that decrease the risks of dangers but that don't interfere with legitimate biomedical researchers," Mulligan explained.

"The key thing to remember in this whole area is that there aren't any magic bullets," he added. "There's no one solution that's going to remove the problem forever. This is a small sensible step that reduces the risk of one specific kind of problem … you should look at it as one of many steps that sensible people involved at all levels are taking to reduce risks."

Mulligan called it "a really positive sign that the government has focused sensibly on this problem, thought about it carefully over several years, and then come out with a reasonable set of proposals that … I think have been fairly well received."

The IGSC is just one group working on regulations for the synthetic biology industry. Last month, the Europe-based International Association of Synthetic Biology announced that it had finalized its code of conduct for gene synthesis, covering ethics, biosafety, and biosecurity aspects of gene synthesis. Members of that group include Entelechon, ATG:Biosynthetics, Biomax Informatics, Febit Synbio, and Sloning BioTechnology.