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Policy

Government Acts On Biosecurity

Policy: Federal guidelines on oversight of dual-use research emerge without fanfare

by William G. Schulz
April 9, 2012 | APPEARED IN VOLUME 90, ISSUE 15

[+]Enlarge
Credit: Chris Condayan/MicrobeWorld
Avian flu researcher Fouchier (right) addresses concerns about his work at a biosecurity conference last month in Washington, D.C., as NSABB members Paul Keim (center) and Michael Osterhelm listen.
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Credit: Chris Condayan/MicrobeWorld
Avian flu researcher Fouchier (right) addresses concerns about his work at a biosecurity conference last month in Washington, D.C., as NSABB members Paul Keim (center) and Michael Osterhelm listen.

A long-awaited federal policy on oversight of dual-use research in the life sciences was issued on March 29 on a somewhat obscure government website (oba.od.nih.gov). The policy comes in the midst of controversy over the conduct and publication of two recent H5N1 avian flu experiments.

The policy document was quickly followed by a statement from the National Science Advisory Board for Biosecurity (NSABB) citing that same policy for its new recommendation to publish—in a revised form—H5N1 avian flu research that involved key mutations of the virus. Previously, the federal biosecurity advisory board recommended that only heavily redacted forms of the research be published, citing dual-use and biosecurity concerns because the work adapted the virus to mammals and rendered it aerosol-transmissible (C&EN, Feb. 6, page 6).

“The data described in the revised manuscripts do not appear to provide information that would immediately enable misuse of the research in ways that would endanger public health or national security,” NSABB’s statement says.

The purpose of the new dual-use research policy “is to establish regular review of the United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern,” it states. The four-page document explains how the policy relates to existing government regulations; definitions it employs; scope of coverage, including lists of pathogens and experiments that will raise red flags; and department and agency responsibilities.

Questions including how the agency reviews are to be conducted and by whom, which specific government officials or advisers developed the policy, and what input those officials received from the scientific community have gone unanswered by federal officials. The NSABB statement was released after a two-day, closed-door meeting—meaning participants are not permitted to talk about their deliberations—on March 29 and 30.

“The new policy guidelines are a positive step, but I will monitor them as they are implemented,” Rep. F. James Sensenbrenner Jr. (R-Wis.) said in a March 30 statement. Previously, the vice chair of the House of Representatives Committee on Science, Space & Technology had questioned Office of Science & Technology Policy (OSTP) Director John P. Holdren about the lack of such a policy from the Obama Administration. A spokesman for Sensenbrenner says the congressman still awaits a formal response from Holdren.

The dual-use policy and NSABB documents are posted on a webpage belonging to the National Institutes of Health’s Office of Biotechnology Activities, which coordinates science policy on relevant biological research across several federal agencies and is also the home of NSABB. C&EN phone calls to NSABB, NIH, the Department of Health & Human Services, OSTP, and Sensenbrenner’s office concerning who issued the policy and is thus responsible for explaining details were passed around among that group. Finally, on April 3, a spokesperson for OSTP told C&EN only that “the policy was developed through an interagency process” and that it is effective immediately.

Science Editor-in-Chief Bruce Alberts released a statement referring to Ron A. M. Fouchier, one of the principal investigators of the H5N1 research. “We are pleased by the NSABB’s decision to recommend publication of a revised version of Dr. Fouchier’s article that presents the data, methods, and conclusions in an unredacted form,” Alberts said. He continued that a revised version of the manuscript would need to undergo further peer review and that he could not yet set a publication date.

At Nature, where another H5N1 research paper has been accepted and awaits publication, Editor-in-Chief Philip Campbell also expressed satisfaction with the new NSABB recommendation. “Subject to any outstanding regulatory or legal issues, we intend to proceed with publication as soon as possible,” he said.

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