A study looking into the safety of Boston University's newly built National Emerging Infectious Disease Laboratory has been delayed, which has in turn pushed back to at least the coming fall a court decision on the fate of the facility.
A court decision on the opening of the 192,000-square-foot, $198 million Biosafety Level 4 lab, entrenched in a long-running legal dispute, will be delayed until fall of 2010 at the earliest, and possibly later.
The study, which will be released for public comment, calls for the National Institutes of Health to perform supplemental risk analyses into the ability of the lab to contain 13 toxins to be studied there, and to ensure that it can be operated safely.
NEIDL is intended to perform basic and clinical research into infectious diseases, which in recent years have included West Nile virus, Ebola, avian flu, and HIV.
The supplemental risk analyses began last year but will take longer than the June 2009 timeframe projected late last year for completing a draft analysis report, NIH, BU, and Boston Medical Center Corp. stated in a legal filing submitted earlier this month to US District Court Judge Patti Saris.
"The NIH estimates that a draft of the supplemental risk analyses will be available for public comment during the winter of 2009-2010, followed by a final supplemental risk-analyses document that responds to all public comments made on the draft during the spring or summer of 2010, "the legal filing stated.
The corporation runs Boston Medical Center, a private, not-for-profit, 626-bed academic medical center that serves as the primary teaching affiliate for Boston University School of Medicine.
The supplemental draft risk assessment, conducted by Tetra Tech, is overseen by a panel convened in March 2008 by the NIH's Advisory Committee to the Director — four months after the National Research Council concluded that the NIH used flawed research methods in a draft supplemental environmental review.
That analysis concluded the NEIDL was safe, and did not make clear the reasoning behind those methods, or the findings derived from them [BRN, Dec. 3, 2007].
The 16-member panel, which will next meet May 5 at NIH's Bethesda, Md., headquarters, is chaired by Adel Mahmoud, professor in the Department of Molecular Biology and Woodrow Wilson School of Princeton University.
According to the Jan. 9 edition of the NIH Record, the panel "will oversee the [supplemental risk assessment] study and report [its] results in June 2009."
The outcome of the panel process "will be a rigorous and comprehensive evaluation that will consider the questions and concerns raised by the public, the National Research Council, and the Federal and State courts with respect to construction of the NEIDL," the panel said in a Q&A posted on its web site.
"Upon review of the panel’s comments and suggestions, the NIH may do any or all of the following: conduct additional risk assessments, as warranted; revise the current draft supplementary risk assessments report, as necessary; solicit public comment on any new reports that may be generated; and submit final reports to the relevant authorities," the panel said.
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The final supplemental risk assessment is supposed to incorporate comments from the NRC and from the public. The NIH, BU and the BMC proposed in the legal filing that Saris allow up to 45 days from when the final supplemental document is released and noticed in the Federal Register for filing of motions for summary judgment and/or permanent injunctive relief, followed by another 30 days for opposition memoranda.
"Based on the projected issuance of a final supplemental NEPA decision document, briefing should be completed in time for the court to hold a hearing in the fall of 2010," the NIH, BU, and the BMC wrote in the legal filing. They added that they "are cognizant of, and will observe, the limitations the Court has placed on the operations of the Boston-NBL pending the completion and review by the court of the supplemental NEPA analyses."
BU, citing the need for safety, has expressed support for the supplemental risk-assessment effort.
The delay has also pushed back BU's plan to temporarily use the lab as a venue to conduct training exercises for scientists as well as city, state, and federal officials interested in testing safety, health, and operational procedures.
"These exercises will provide the opportunity to test and revise the scientific standard operating procedures (SOPs); overlay emergency responses (internal and external) to simulated incidents; familiarize regulatory departments and agencies with laboratory operations; and, familiarize community residents with how research protocols will be conducted in the laboratories," BU said in its press release last August announcing the training.
"During the training exercises no research will be conducted and no research agents will be used in the building," BU added.
At the time of the announcement, BU anticipated launching the training exercises in February, but that timeframe has been pushed back to later this spring.
"We just slowed down the planning as the timing of the opening slowed. There is no rush to do it," BU spokeswoman Ellen Berlin told BRN on April 16.
BU would not say whether it could abide by an indefinite delay in the full use of NEIDL, or what, if any, consideration it has given to alternative uses if the process drags on past current projections for the draft and final risk assessments.
"We believe that this is an important process, and appropriate time should be spent on it," Berlin said.
The NEIDL, originally proposed in 2003, sits within a freestanding Albany Street building recently completed within BU’s BioSquare research park, where 582,000 square feet of space currently houses three buildings.
The lab has since been opposed by a coalition of critics consisting of neighbors, community activists, and researchers who contend that its BSL-4 facility would be unprepared to combat an accidental release of toxins outside its lab, and should instead minimize its risk to the community by operating in a less-densely populated neighborhood.
In 2006, the Boston-based Conservation Law Foundation and 10 residents living near the proposed lab site in the city's Roxbury and South End sections filed a series of lawsuits in federal and state courts to overturn city, state, and federal approvals for NEIDL.
Plaintiffs prevailed that year when Suffolk Superior Court Judge Ralph Gants vacated the state’s certification that the project’s original environmental report complied with Massachusetts law. Gants ordered a new environmental review with more information on the merits of a less-populated site for the lab as well as how well it could respond if a toxin escaped from the lab.
Following that decision, the NIH and BU agreed to prepare a draft supplemental review, address concerns raised in the federal case by submitting a risk-assessment report, and to appeal Gant’s ruling.
In the resulting “Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory,” BU concluded that the lab poses no increased risk of transmitting Ebola, monkeypox, Sabia virus, or Rift Valley fever in the South End site where it is being built, compared with two alternative locations where BU has operated programs, includjng Tyngsborough, Mass., and Peterborough, NH.
That report was eventually skewered by the National Research Council, which led to the current NIH study. Representing the residents in their court challenge to NEIDL is Peter Shelley of the CLF. A foundation spokeswoman at deadline had not responded to telephone messages from BRN.
The NEIDL is one of two National Biocontainment Laboratories — the other is at the University of Texas Medical Branch in Galveston — planned by the US National Institutes of Health to battle emerging infectious diseases in the years since the Sept. 11, 2001, terrorist attacks and a subsequent wave of anthrax attacks.
The NIH has also designated 13 regional biocontainment laboratories, all of them Biosafety Level 3. The closest one to NEIDL is 30 miles west of Boston in Grafton, Mass., where Tufts University on March 30 dedicated its $33.7 million New England Regional Biosafety Laboratory on the school’s North Grafton, Mass., campus [BRN, March 30].