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Opponents of BU Biolab Seek Further Review After NRC Slams NIH Report as ‘Not Credible’

Opponents of a National Emerging Infectious Diseases Laboratory being constructed by Boston University said last week’s skewering of a federal draft supplemental environmental review of the project by an arm of the National Academy of Sciences warranted a re-examination that could scuttle the project altogether.
An 11-member committee of the National Research Council issued a Nov. 29 report contending that the National Institutes of Health used flawed research methods in its DSER and did not make clear the reasoning behind those methods, or the findings derived from them.
“The committee finds that the [NEIDL plan] is not sound and credible,” according to the 28-page report. “By this, the committee means that the conclusions reached in the report are not adequately supported by the analyses nor are they credible.”
The DSER “would have failed” if submitted for publication in a peer-reviewed scientific journal, declared a committee member and one of the NRC report’s authors
The DSER agreed with many of the arguments raised by independent opponents of the NEIDL, who took issue with the research methodology used to assess the environmental risks of the project, which aims to open next year a Biosafety Level 4 lab, the highest level of containment, in the university. [BioRegion News, Sept. 17].
Speaking with BioRegion News last week, three opponents of the NEIDL project said the research council’s report should prompt the NIH to launch new efforts to study the project’s environmental effects, along the lines suggested by the research council. They also urged Boston University to scale down the biosafety level of research set to be conducted at the lab.
“This demonstrates that the information that has been used up to now is not credible,” said Eloise Lawrence, staff attorney with the Boston-based Conservation Law Foundation, in an interview. “Therefore, it’s time for people to re-examine the initial decision to place a laboratory that would deal with many of the most dangerous materials in the world in a residential neighborhood.”
Years of Local Opposition
BU’s $178 million, 192,000-square-foot NEIDL would be within a freestanding building now under construction within BU’s BioSquare research park, where 582,000 square feet of space currently houses three buildings. 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 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 plans to open a $25.8 million BSL-3 lab in early 2009. Construction for the 37,950-square-foot facility began in September, five months after the town planning board sided with the school over opponents in approving the facility. [BioRegion News, May 7].
Back in Boston, BU has argued the project would yield such economic benefits as more than 1,300 construction jobs and an anticipated 660 permanent jobs. The university will pay the city of Boston $1.9 million in job training and housing linkage payments, and BU and the medical center have promised to maintain previously agreed payments to the city — a combined $3.2 million in annual in-lieu-of tax payments and a combined $3 million in taxes.
Over the next 20 years, BU has projected the lab would generate $2.9 billion in economic activity in Boston.
But a coalition of critics consisting of neighbors, community activists, and researchers has argued since the plan surfaced in 2003 that BU’s 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.
“We’re going to continue to say what we’ve said all along,” said Lawrence. “Because of its enormous significance to residents in the South End and all of Boston, the government needs to address what are the environmental impacts of the project, what are the risks, and then regulate for them.”
During the summer of 2006 Lawrence’s CLF and 10 residents living near the proposed lab site had filed a series of lawsuits in federal and state courts to overturn city, state, and federal approvals. The plaintiffs prevailed in July of 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.
Also in July, the NIH and BU’s resulting “Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory,” Boston University 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.
The NRC report recommended more study of another key argument of NEIDL opponents — that the project would undermine “environmental justice” by creating health risks that would fall disproportionately on residents of the nearby black neighborhoods of Roxbury and Dorchester if an infectious agent were inadvertently released from the lab.
Massachusetts Gov. Deval Patrick ’s office entered the fray. But after concluding that it lacked in-house expertise to weigh in on NEIDL, Patrick commissioned his Executive Office of Energy and Environmental Affairs to study the DSER.
The executive office will submit its comment on the DSER to the NIH, a spokesman for the agency, Robert Keough, told BioRegion News. “This won’t spur any additional state action,” Keough said.
BU spokeswoman Ellen Berlin said the NIH/BU review will be completed next year, “between now and spring.” The state’s energy and environmental affairs office will review the NIH/BU review at that time, Keough said.
That study should go beyond earlier environmental reviews by NIH and BU, which concluded that the lab would be safe, a critic of the NEIDL project told BioRegion News via e-mail.
“I think the [National Research Council] conclusion should give pause to government officials who, until now, have been either supporting the BU plan or taking no position,” Jeanne Guillemin, senior advisor for the Massachusetts Institute of Technology’s Security Studies Program, wrote to BRN last week on Nov. 29.
“At this point Boston University should be reconsidering its use of the Albany Street building — thinking, for example, of scaling it down to Level-2 research,” Guillermin added.
Echoing Guillermin is Lynn Klotz, a senior science fellow with the Center for Arms Control and Nonproliferation in Gloucester, Mass.
“My hope is that this NRC report will make Boston University think about scaling back to a state of-the-art BSL-2 facility, with perhaps a small BSL3 as backup for some specific experiments.  Perhaps BU would also consider emphasizing infectious diseases relevant to poor urban populations as well,” Klotz told BioRegion News via e-mail.
Klotz has faulted the NIH for choosing to study in the DSER the effects of infection from ebola, sabia, monkeypox, and Rift Valley fever, rather than more contagious diseases such as avian flu and SARS. He has also contended the NIH should have addressed factors where population density would add to risk, such as an aerosol release of avian flu and SARS within a densely populated community.

“Although the NIH did respond in writing to questions submitted by the [NRC] Committee, the Committee was unable to engage in a meaningful scientific discussion with the scientists contributing to the DSER.”

In its report, the NRC agreed with Klotz, saying the NIH “did not effectively examine highly infectious agents that would be of greater relevance to comparing the risks at the three sites. In this and other ways, the DSER did not provide a representative worst-case scenario.”
The research council also said the NIH erred in basing its assessments of the community risk from a toxin release on the infection of four hypothetical sufferers, one of whom brings on infection in his family and his daughter’s first grade classmates: “While such incidents are possible, there are other ways to initiate infection and disease, such as inadvertent laboratory release or malevolent action. These other modes of release can have far more serious consequences than those modeled in the DSER.”
The report also found that the DSER should have accounted for three factors deemed to pose a special risk to the neighborhoods near planned BSL-4 labs: the prevalence of asthma, poor nutrition, and immunosuppressive diseases like AIDS; public-health issues such as inadequate access to medical care and services; and the presence of insects, rodents, and other disease vectors.
As a result of the flaws, the DSER “would have failed” if submitted for publication in a peer-reviewed scientific journal, declared a committee member and one of the report’s authors, University of Pennsylvania epidemiologist Gary Smith.
“You have to make it clear to your intended audience what you did to the extent that they could at least begin to imagine that if they had the same facilities, they could repeat the work, It was not clear in many ways how the modeling was done, and that was a deficit,” Smith said during a conference call with reporters. “There were also too few discussions about why some elements were included in the model and why some elements were not included in the models.”
Smith said that because the research methodology was detailed enough to include specific ages, work locations, and travel times for the four hypothetical infection cases, “it seemed to the committee that there exists the opportunity to also examine differences in susceptibility between particular populations to these pathogens. And that was an opportunity that was missed by the modelers.”
One such difference that Smith cited involves monkey pox, which he said results in more severe illness, and a “slightly” higher possibility of death, in children than adults.
NIH Responds
Responding to the research council report, NIH issued a statement declaring in part that it “appreciates the thoughtful and rigorous scientific review of this draft document by the NRC Committee and will consider their comments along with all others received from the Boston community and elsewhere.”
The statement also cited NIH’s affirmation last year that the NEIDL project was safe, and said its DSER was not designed to answer concerns raised in the state case.
In its report, the committee said it was prevented by NIH from speaking directly to agency personnel carrying out the supplemental environmental review, though the NIH instead answered written questions posed by the committee. On Dec. 3, the National Academies — an umbrella group that includes the research council and the National Academy of Science — released a copy of the written responses, the same day the NIH posted the responses on its web site. Both actions followed requests by BioRegion News.
Asked by the committee why NIH did not study the effect of a “malevolent” release of toxins as sought by the state, NIH responded by noting the DSER was developed as part of the federal lawsuit, not the state’s, and that the state never formally asked the agency to study the issue. “The draft supplemental report was prepared to address concerns raised by the public involving the release of Biosafety Level-4 infectious agents into the community under complex scenarios. The Commonwealth of Massachusetts can provide comments to the NIH on the Draft Supplemental Report in the same manner as any member of the public, and the NIH will respond to all comments in the final version of the report.”
NIH also provided references in scientific journals for the modeling concepts used in the DSER, and sidestepped a question about what it considered a worst-case scenario, adding: “Since a definition was not provided in the Draft Supplemental Report, the panel's question does not fall within the scope of technical clarification that NIH can provide at this time. The NIH will respond to all comments, including questions, on the Draft Supplemental Report in the final version of the report.”
NIH’s decision to communicate only through the written responses drew criticism from the committee in its report. 
The “NIH legal counsel determined that the presenting NIH scientist and the scientists contracted to work on the DSER could not answer any questions from the Committee during the open meeting because of restrictions imposed by the NEPA process,” the report stated. “Although the NIH did respond in writing to questions submitted by the [NRC] Committee, the Committee was unable to engage in a meaningful scientific discussion with the scientists contributing to the DSER.”
In a statement, Boston University said that “we recognize that the National Research Council report states a number of concerns regarding the NIH methodology and analysis and [we] are confident that the NIH will address those issues in its final report.
“In the meantime, we stand ready to provide whatever information we can in order to respond to questions and concerns, and to document that the South End site is as safe as or safer than alternative locations.”
The statement did not categorize the arguments made by the research council committee, and Berlin said the university would not comment on them — or what it would do if the federal and state courts were to prevent BSL-4 approval and force BU to operate its lab at a lower biocontainment category. “We’re working toward and are confident that the lab will open as designed.”
Berlin said the research council committee’s report would have no effect on construction of the BSL-4 facility, set to open next year. She said the facility was “70 percent” complete — the same percentage BU told BioRegion News in September. Berlin said the university misspoke at the time and should have described construction back then as 50 percent complete.

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