Biolab officials hoping to start research this year
Some groups suspicious of BU’s waiver request
by Kate Vander Wiede (From South End News), August 17, 2011
Boston University Medical Center is hoping they will soon be able to start research in the National Emerging Infectious Disease Laboratory (NEIDL) later this year, explained press contact Ellen Berlin.
“The laboratory has been built and it was completed in September 2008,” she said. “We’ve thought that rather than leave the building empty … that it made sense to put lower safety level labs to use now.”
For the last nine years, since the NEIDL’s (or Biolab’s) inception, many community members have opposed the facility, which is located on Albany St., for safety reasons.
Failed risk assessments and litigation concerning the kind of research that would be done in the Biolab have delayed its use. Though the university has been barred from doing any research while the National Institute for Health (NIH) oversees a risk assessment, university administrators are hoping to get a waiver from the Federal court so that they can proceed with low safety level research.
The Biolab was created in part to perform high-tier research. Much of the controversy surrounding the Biolab has centered on the university’s plan to do “biosafety level 4” (or BSL-4) research. Among other things, BSL-4 research is defined as research performed on or with “dangerous/exotic agents” that have a high “individual risk” of aerosol-transmitted laboratory infections that are “frequently fatal,” and which have “no vaccines or treatment,” a form on the Center for Disease Control website explains.
Opponents of the lab have argued that the South End, full of at-risk communities like the elderly and disabled, a large population and mass-transit systems, is no place for a lab that studies such agents. Proponents have argued that a place like Boston, with its strong scientific and medical community, is actually the perfect place to perform such research.
Neither has given in on their views, and this has led to a number of contentious community meetings and litigation.
The aim of getting a waiver is so BUMC is able to start BSL-2 research by the end of 2011. Berlin said BSL-2 research is done in hundreds of labs in Massachusetts. Though the waiver request will also ask for permission to do BSL-3 research, which Berlin said is done at 28 other laboratories in Massachusetts. Though they will ask for the waiver, Berlin said BU would not start BSL-3 research until the current risk assessment is done.
Opponents have had a deep distrust of BU since the initial risk assessment was found to be faulty, and that distrust was evident after BU’s announced they would try to get a waiver.
“We need to know much more about the waiver request, particularly with regard to BSL 3, in order to reach an opinion about its merits,” wrote Klare Allen, the leader of the Roxbury Safety Net & the STOP the BU-Bio-Terror Lab Coalition, in a press release, “but our immediate reaction is one of suspicion.”
She went on to ask several questions: “Is this an end run around the risk assessment review process? What kind of oversight will there be to ensure that research being conducted meets community standards? What kinds of emergency processes will be in place? How will the national security of the NEIDL facility be maintained?”
Allen added, “We will carefully review BU’s waiver request when it is made available to us.”
Berlin said that because the permitting process and final approval process for BSL-3 research is long, getting the waiver now would allow them to quickly get moving on research once the risk assessment is done.
“The process is a long process and we want to be able to start it,” Berlin said.
If the waiver is approved, BU would be allowed to gain permission to do research from their Institutional Biosafety Committee, the Office of Environmental Health and Safety, the Boston Public Health Commission and the Occupational Health Officer.
BU was chosen as the recipient of a grant to build the Biolab in 2003.
At the time, as a part of the permitting process, The Massachusetts Executive Office of Energy and Environmental Affairs (MEOEEA) “required BU to prepare a Final Environmental Impact Report (FEIR) to satisfy the requirements of the Massachusetts Environmental Policy Act (MEPA),” the Blue Ribbon Panel’s website reads. The NIH also completed a Final Environmental Impact Statement that concluded the Biolab posed “negligible risk” to the surrounding community.
A group of residents and community groups who oppose the Biolab objected to this conclusion, and filed lawsuits in state and federal court in 2005 and 2006, respectively. Around this time, the NIH began preparing a draft risk assessment for the federal court trial, focusing on the how the release of several BSL-4 agents would impact the community.
In July 2006, the federal court found the university’s FEIR did not consider any “worst case” scenarios in which contagions are accidentally or purposefully released from the Biolab. Furthermore, the court said the FEIR did not analyze whether this “worst case” scenario would be “less catastrophic” if the lab was located in a less densely populated area.
The judge voided the approval of the FEIR, leading the state’s office of Energy and Environmental Affairs to request that BU submit a supplemental FEIR (SFEIR) to address the shortcomings found during litigation. The MEOEEA also asked the National Research Council to review the draft supplemental risk assessment that the NIH had prepared for the federal trial. Following the NRC’s critical analysis of the risk assessment, which was described as too analytical, the NIH decided to create its first-ever Blue Ribbon Panel
Made up of independent experts on infectious diseases, public health and epidemiology, risk assessment, environmental justice, biodefense, and biosafety, the Panel it was charged with making sure the risk assessment was done properly.
During the current risk assessment process, which has taken more than three years so far, BU has not been allowed to do any kind of research in the labs. Though much of the community’s concern has revolved around BSL-4 research, facilities for which this research only takes up 16 percent of the building. This has meant the entire building has sat unused for years, with only training exercises taking place.
At the end of 2010, in response to NIH’s work so far, the NRC submitted another critical review of the risk assment.
“The committee reviewed the material … and concluded that it cannot endorse as scientifically and technically sound the illustrative analyses presented,” wrote John Ahearne, chair of the committee that reviewed the assessment.
Ahearne wrote that the NRC previously “strongly recommended” that qualitative analyses be used to answer three questions that were raised previously about the 13 agents that will be studied in the Biolab’s top safety-level lab: “What could go wrong? What are the probabilities? What are the consequences?”
Instead of using data and case studies to answer these questions, the contractor Tetra Tech, who was hired by NIH to lead the assessment, used the averaged opinion of eight experts, modeling possible risk situations based off those opinions.
This, the NRC report said, was “a tactical error.” The NRC found several other issues with the risk assessment as well, noting that “much work needs to be done before risks are adequately addressed.”
Since that report, the Blue Ribbon Panel has not held any community meeting. The Panel’s website reports there will be another community meeting in late 2011, where the next version of the risk assessment will be presented to the public.