Tiers of safety at the Biolab

by jeeg 10. November 2011 21:50

Ominously referred to as "The Needle", the 192,000 square-foot National Emerging Infectious Disease Laboratory (NEIDL) on the Boston University Medical Center (BUMC) campus stands inactive and empty, as it has since its completion in 2008. Research there cannot commence until a protracted risk assessment process satisfies regulators and the courts.

In the meantime, B.U. recently asked the state for a waiver that would allow some lower-level research to begin at the lab while the approval process for riskier research grinds on.

The lower-risk research, which falls under the biosafety level 2 (BSL-2) section, already takes place in many labs across the state, while the type of research largely responsible for holding up the lab’s approval, BSL-4, involves highly contagious and lethal viruses with no known vaccines or therapies.

On Tuesday evening, BU representatives met with members of the Blackstone/Franklin Square Neighborhood Association (BFSNA) to discuss the waiver request and address questions surrounding safety at the lab.

David Flynn, BUMC Associate Vice-President for Facilities Management, reviewed a three-tiered approach to safety at NEIDL.

Complex mechanical systems for air pressure, air filtration, electric power, water, and thermal supply comprise the first tier. Flynn described the constant monitoring and management of these systems. "We have an enormously sophisticated building management/building automation system...there are an infinite number of points that we are monitoring at all times," he said. Stressing the importance of redundancy in the building’s systems, Flynn described the lab’s massive rooftop generators, capable of powering the entire facility for up to 54 hours without refueling, and the multiple sources for municipal water and steam heat that serve the lab.

A second tier of safety control is at the administrative level; Flynn described protocols, based on international "best practices", that are in place for staff, both facilities workers and researchers. "There are a number of people in the NEIDL who spend a whole lot of their time making sure that these protocols are well documented, that they are accessible, and that they’re not done in a vacuum: that they’re actually shared amongst all the people that are in the building." Training in these protocols and standard procedures, Flynn said, is an essential part of the lab’s operation.

Thirdly, personal protective equipment -- specialized suits, masks, and other gear, comprises the front line of safety for researchers and other workers in high-risk areas of the lab.

What concerns people living nearby, however, is the chance that despite all of these precautions, somehow something could still go terribly wrong.

Neighborhood resident Fritz Klaetke pressed BU Senior Vice-President of Operations Gary Nicksa on NEIDL’s densely urban location, saying that he hoped those assessing the potential for an incident involving BSL-4 research at the lab "have experienced at five o’clock rush hour around here."

Klaetke further questioned B.U.’s reasons for seeking to do such high-level research at the facility, when the lab could conceivably instead conduct only BSL-2 experimentation. (Only 16% of space at NEIDL is set aside for BSL-4 work). In response, Nicksa replied that BSL-4 capability is part of NEIDL’s mandate from the federal government agency providing funding for the lab. Said Nicksa, "Our mission, our charge from NIAID (National Institute of Allergy and Infectious Diseases) in doing the type of research that we would like to do, was to be able to go all the way through the level-4 review."

According to NEIDL Associate Director Ronald Corely, when and if the lab does eventually attain approval to run BSL-4 testing, researchers will have to obtain permission from the Centers for Disease Control (CDC) for each separate virus, or so-called "select agent" they wish to study.

Scientists hoping to get their hands on BSL-4 bugs like the Ebola or Marburg viruses still have plenty of time to wait. The National Institutes of Health’s (NIH) Blue Ribbon Panel, a group of experts which has been overseeing a complete review of earlier public health risk assessments found inadequate by a federal court, is due to release its report, the final draft supplementary risk assessment, for public comment early in 2012. On November 2, the NIH panel met with another institution vetting risk at NEIDL, the private non-profit National Research Council (NRC), to discuss the draft assessment.

While the risk assessment process rolls on, BU hopes that their request for a waiver from the Massachusetts Executive Office of Energy and Environmental Affairs will be granted. The waiver would allow NEIDL to begin BSL-2 research, and to apply to the Boston Public Health Commission for permits to allow BSL-3 work (on pathogens that are highly contagious but somewhat less virulent than those at BSL-4.) Nicksa said that he expected an answer on the waiver within the next few weeks.

Asked by BFSNA member Jim Keeney what future community presentations BU may make in the future, Nicksa suggested that there were many possibilities. He requested feedback from BFSNA and other groups as to specific aspects of the lab that needed to be discussed further, and said, "It’s a very complex enterprise, and hopefully the more we come out and talk about it, then when the report (by the NIH Blue Ribbon Panel) comes out, it will be that much easier to understand."

 

Cornelius Howland, My South End 

 

 

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