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Federal Court Supports NIH Review of Biolab Safety Risks

BU’s NEIDL moves closer to full operation

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In an action that moves BU’s National Emerging Infectious Diseases Laboratories (NEIDL) closer to full operation, a federal court judge has ruled that a Final Supplementary Risk Assessment prepared by the National Institutes of Health (NIH) adequately analyzes the risks associated with research involving pathogens at Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4) and that such research can be done safely at the BU Medical Campus site.

That risk assessment, which examined a series of scenarios and potential consequences of procedural failures, including containment system failures and malevolent acts, had been challenged in court by a number of Boston residents and the Conservation Law Foundation. The groups claimed that the risk assessment prepared by the NIH was not adequate and that the NIH decision to approve it was arbitrary and capricious.

In a 76-page opinion, US District Court Chief Judge Patti Saris found that “the NIH provides sufficient scientific support for its ultimate conclusions that the risks to the public are extremely low to not reasonably foreseeable, and the differences between the Boston location and the suburban and rural sites are not significant. In light of the benefits of placing the biolab in an urban area like Boston, which provides opportunity for expert medical research collaboration, and the low risk of harm to the public, NIH’s decision is rational.”

John R. Murphy, NEIDL director ad interim and a School of Medicine professor of medicine and microbiology, says he is pleased that the federal court “went through each and every objection of the plaintiffs in a methodical way and found that they were not warranted.”

“The court is saying that it’s reasonable for the NIH to determine that research using these types of pathogens can be done safely at the NEIDL,” says Murphy. “This is one more step to the opening of the lab.”

Murphy says that one additional judicial hurdle, a similar lawsuit filed in state court, will be heard later this year.

The University has also asked the Boston Public Health Commission for required permits to operate the facility as a BSL-3, and will soon submit documents required for permission to operate as a BSL-4 lab.

Once the lab is open, all research will be subject to at least three systems of supervisions and safeguards. Those include approvals from the Centers for Disease Control, the Institutional Biosafety Committee, and the Boston Public Health Commission.

Construction of the $200 million NEIDL facility was completed in September 2008, but controversy and litigation have kept much of the building’s 192,000 square feet of laboratory space closed. In March, BU researchers moved into the NEIDL, at 620 Albany St., to work on tuberculosis research that has been approved for Biosafety Level 2 (BSL-2) laboratories.

3 Comments
Art Jahnke

Art Jahnke can be reached at jahnke@bu.edu.

3 Comments on Federal Court Supports NIH Review of Biolab Safety Risks

  • Scott Mohr on 10.01.2013 at 9:29 am

    Given the current suite of medical care issues — and the possibility of various forms of bioterrorism — this is truly wonderful news. Of course, eternal vigilance is the price of no catastrophes in a situation like that which faces the NEIDL as it gears up to commence research at levels 3 and 4, but the sheer effort required to obtain permission for full operation should prove motivating to maintain zero safety failures. Having served on a committee charged with approving grant proposals that involved some degree of hazard some years ago, I made a discovery that may be relevant. The committee (chaired by John Sandson, the then ex-dean of the Medical School) had as members both lower-level hospital staff and some South End residents as well as faculty and administrators from both campuses. I fully expected two characteristics from the community and lower-level staff members: (1) limited ability to understand the scientific issues in any detail, and (2) deep-seated, relatively inflexible hostility to projects dealing with serious health risks, particularly those that explored new territory where novel precautions might be required. To my (chagrined!) surprise the community members of the committee held their own on the understanding of key points relative to hazards, and they were more than rational and sophisticated about when, where and how the grants would need to be revised if they did not anticipate clear and adequate procedures to deal with as-yet-unknown types of risk. I describe this experience as an argument for a suggestion about the management of the NEIDL. Since I have not read all the many reports about it, this suggestion may already be superfluous, but if not, please consider it seriously. HAVE COMMUNITY REPRESENTATIVES AND LOWER-RANKED STAFF MEMBERS SERVE ON A SAFETY REVIEW PANEL THAT MEETS REGULARLY. They would see issues with fresh eyes and raise intelligent questions that the local community would wish to see examined. In an era of ever-spreading drug-resistant pathogens like SARS (that can travel around the globe in less than 24 hours) the NEIDL doesn’t need bad publicity and the possiblity of legal injunctions blocking research. It must continue to demonstrate unequivocally that it’s a good neighbor and runs a tight ship.

    • Kate on 10.01.2013 at 12:47 pm

      There is a committee like you describe already in place: http://www.bu.edu/neidl/community/clc/

      • Scott Mohr on 10.01.2013 at 4:15 pm

        Thanks for the information. I could not tell without a search whether or not that type of committee existed. Perhaps my comment will help focus some attention on it. I seriously believe it has a very crucial role to play, both to keep the University’s attention sharply focused on the safety/security issue AND to provide a two-way channel of communication with the community.

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