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As Panel Urges Gov't to Regulate Pathogen Gene Sequences, Genomic Industry Frets Over Innovation

NEW YORK (GenomeWeb News) — A federal government advisory board, eager to ensure that advances in synthetic genomics do not become components of bioterrorism, is recommending that the government regulate gene sequences of pathogens rather than simply regulating the pathogens themselves.
In its quarterly meeting in late October, the National Science Advisory Board for Biosecurity approved recommendations made by the Working Group on Synthetic Genomics, which said that it may no longer be enough to control organisms such as Ebola and Marburg viruses, and that it is now necessary for the government to start tracking DNA sequences and synthetic nucleic acids.
“What we’re dealing with in today’s technology is unlikely to represent what the technology will be like five to 10 years from now,” Claire Fraser-Liggett, president of the Institute for Genomic Research and a member of the working group, told GenomeWeb News this week. The job of the working group, she said, is “not just to focus on where we are today, but to make recommendations for five to 10 years from now.”
The possibility will soon be there “to construct a super-pathogen with very specific attributes,” Fraser-Liggett said.

“It’s almost a little surprising that [the government is] just now getting to this.”

According to the working group, the problem is that the existing rules for pathogens and toxins can not be applied to synthetic genomics. Specifically, the NSABB said that the risk of creating pathogens with genetic variations to sequences from existing organisms is not part of the government’s Select Agent Program, which the Centers for Disease Control and Prevention created in 2002 under the Patriot Act.
The problem with the existing SAR, Fraser-Liggett said, “is that we approach these issues at the level of specific organisms” rather than their genes.
But in synthetic genomics, she pointed out, organisms may be reorganized at the genetic level. She cited as an example hemorrhagic fever, in which “some of the sequences are being cut out [of the organism responsible for the illness] and pasted together, and other sequences from other organisms are being cut and pasted in, and each of these essentially represents a new organism.”
The working group’s central recommendation, she said, “is that current recommendations need to be re-examined … and needs to be looked at in terms of gene sequencing instead of applying to a specific organism.”
John Bishop, CEO of Cepheid, which makes genetic sensors for biosecurity applications, agreed that newly designed or spliced sequences could create security problems, but wonders why it took the government so long to identify this as a problem and take steps to mitigate it.

“We have to be careful we don’t end up handicapping scientists within the US, and not making ourselves any safer.”

“It’s almost a little surprising that they’re just now getting to this,” Bishop told GenomeWeb News this week. “As you get into genomic modification of organisms — and there have been many articles written in biothreat area about it — you have situations where organisms have been modified and genomes spliced together to create very dangerous organisms.”
Although Bishop said the issue may have been neglected for years, he thinks the NSABB proposals may do more harm than good. Genomics, he said, is a “major, worldwide phenomena. To try to regulate it would be difficult and probably not very effective.”
Urging Change
Current SAR rules outline who may have access to select agents and require background checks for access. They also regulate how the agents must be stored, handled, transported, and how records should be kept detailing their use, movement, and quantities.
The working group said it wants to make the genetics language in the SAR match that in Commerce Control List, which outlines various material regulated by the US Department of Commerce, and then try to create a flexible regulatory frame that allows future laws to expand as genomic technologies and applications evolve.
The working group also wants to create a way for regulators to know who has what DNA sequences and agents, what quantities they have, where they are located, and roughly what is being done with them.
Cepheid’s Bishop said he sees the potential for a lot of red tape that may hinder science. “One needs to be very careful when you start toward over-regulation,” he said, “because you’re regulating materials people are working with every day, and you slow down scientists by setting up a bureaucracy to review and approve everything.”
David Relman, a working group member and an associate professor of immunology and infectious disease at Stanford University, conceded that it is difficult to develop a framework for regulating gene sequences. He said the challenge “arises from lack of consensus among scientists regarding an appropriate approach and methods for identifying and defining select agents for screening sequences.”
For her part, Fraser-Liggett said trying not to constrain the research is a core concern of the working group. “We have to be careful we don’t end up handicapping scientists within the US, and not making ourselves any safer,” she said.
Bishop also said that while there may be cause for safety concerns, “we have systems in place already, regulations in place,” which, coupled with the incredibly hi-tech instrumentation and the super-sensitive materials, make genomic bio-terror a very difficult game for would-be terrorists to break into.
But the ability to obtain synthetic nucleic acids, Relman said, is one of the working group’s concerns. Fraser-Liggett added that “you can buy sequencers on e-Bay from former users.”
Now that the NSABB has approved the working group’s recommendations, what happens next is not yet known. Fraser-Liggett said the next step will probably be to construct another committee with a wider pool of knowledge and include researchers with more specific expertise to look at all of these issues in greater detail.
“This sounds like we’re passing the buck,” Fraser-Liggett said, “but we didn’t feel our committee had sufficient expertise.” She does hope they will eventually create an alternate framework to the current SAR which “gets away from saying ‘if an organism is known by this name, we regulate it.’”
Fraser-Liggett does not expect researchers will have to start checking in with the government on synthetic genomics right way. “It will take a while to sort all of this out,” she said.

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