The Struggle Against the Boston University BSL4 Biolab

Lawyers’ Committee for Civil Rights Under Law, July 19, 2010

For nearly a decade, the communities of Roxbury and the South End have struggled against the placement of a biodefense research laboratory in their neighborhoods. These predominantly low-income communities of color would be forced to house lethal pathogens such as the Ebola virus and SARS. To make matters worse, Boston University and the agencies responsible for the laboratory have failed to gain credibility within the eyes of the community because of their numerous failed attempts at assessing the risk their work poses to the community and surrounding neighborhoods, and their repeated failures to operate their existing laboratories in accordance with accepted procedures. Community residents filed Environmental Justice lawsuits at both state and federal levels to assert their rights. A judge ruled that to approve the laboratory based on Boston University’s first risk assessment would be an “arbitrary and capricious” decision. An independent scientific review found the project proponents’ second risk assessment to be not sound or credible.  The third and currently ongoing attempt at assessing risk has been outsourced to a private consultant and has consistently missed deadlines to date. Put simply, the people of Roxbury and the South End do not believe that the project proponents have the capabilities to harbor the world’s deadliest pathogens in the communities where their families work, worship, learn, and play.

Background: A High-Risk Biolab in Roxbury

In February 2002, the National Institute of Allergy and Infectious Diseases (“NIAID”), an institute within the National Institutes of Health (“NIH”), a federal agency, launched its Biodefense Research Agenda (“Agenda”). To achieve this agenda, NIAID developed a plan to select and fund multiple laboratories to expand research on the most high-risk disease organisms that could potentially become bioterrorism agents and also to assist in the event of a bioterrorism emergency. These laboratories vary in biocontainment precautions based on the type of biological agents present; the highest level of precaution is Biosafety Level 4 (“BSL4”).

In February 2003, Boston University (“BU”) submitted a proposal to NIAID to construct a facility known as the National Emerging Infectious Diseases Laboratory (“NEIDL” or “BU Biolab”) with a BSL4 laboratory that would be sited in the midst of the Boston University Medical Center. This laboratory would be built as part of the Agenda. NIAID approved the proposal for $128 million.

The census tract in which the BU Biolab is being sited and the adjoining census tract are comprised of very poor and predominantly minority populations, many of whom live in public and subsidized housing. A majority of these residents are African-American and Latino, with median annual household incomes ranging from $11,572 to $26,894. For instance, Cathedral Housing Development, comprised largely of African-American and Latino residents – many of whom are single mothers – is located two blocks from the project site.  Adjacent to the housing development is a grammar school whose pupils are minority and low-income children.

The poor health of many residents in the surrounding one-mile radius is a significant concern, given the added health risks that would come with siting a BSL4 in this neighborhood. African-American Bostonians are hospitalized at a 50% higher rate than white Bostonians, a definitive indicator of their overall poorer health. The majority of people living in the nine Roxbury block groups located around the BU Biolab are African-American.  They are, by reason of overall poorer health, more vulnerable to the stress of having a high risk facility within a mile radius of their homes and more vulnerable to the effects of a potential escape of pathogens from the facility. Further, many Roxbury residents use Boston Medical Center, a nearby facility, for their primary health services. As a result, their health access would be jeopardized by a Biolab-related transport accident, fire, release, or terrorist event.

This already overburdened community has been struggling against the BU Biolab for nearly a decade. In 2000, Safety Net, a resident empowerment group committed to healthy development, began organizing in housing developments throughout Roxbury. In March 2002, Safety Net learned of the BU Biolab from an anonymous phone call and were told to attend a community meeting already in progress. Safety Net attended this meeting, which otherwise consisted more than one hundred scientists. BU Associate Provost for Research Mark S. Kempler described the diseases BU would be bringing to the community: the plague, Ebola, anthrax, and others. Safety Net immediately began preparing opposition to the NEIDL. Klare Allen, a Roxbury environmental justice community organizer for Safety Net, recognized that placing such a facility in a community already plagued with a host of environmental injustices was a gross violation of environmental justice principles, and that those pre-existing conditions should be considered when siting such facilities.  In 2003, at the urging of Safety Net, City Councilors Chuck Turner, Maura Hennigan, and Charles Yancey filed an ordinance to ban BSL4 research in the city of Boston, thus raising a citywide effort to educate and inform residents. Safety Net then approached Alternatives for Community and Environment (“ACE”) in June 2003 for assistance in developing an environmental justice challenge against the laboratory. ACE connected residents with pro bono attorneys who filed lawsuits challenging both the initial siting decision and the subsequent risk assessments.

In an effort to build support for the ordinance banning BSL4 research in Boston, the Roxbury Safety Net expanded their outreach by holding forums at various locations throughout the city. A broader group, the STOP the BU Bio-Terror Laboratory Coalition (“Coalition”), commenced in July 2003. Duplicating Safety Net’s outreach methods, the Coalition grew from a citywide residents’ coalition to a Greater Boston coalition including: community residents; civil rights groups, such as the National Association for the Advancement of Colored People – Boston and National Branches, and the League of United Latin American Citizens – Boston Chapter; unions, such as the Service Employees International Union and the Massachusetts Nurses Association; scientists; peace and justice groups, such as Pax Christi, Women’s International League for Peace and Freedom, and United for Peace and Justice; and community leader groups, such as the Roxbury Neighborhood Council, Cathedral Residents’ Task Force, Orchard Gardens Resident Association, Fortes House Senior Housing, Haley House, Grant Manor Resident Task Force, and Greater Roxbury Workers’ Association. Further, Coalition members from five surrounding cities and towns (Arlington, Brookline, Cambridge, Newton and Somerville), led by Vicky Steinitz, have since succeeded in convincing their local councils to pass resolutions opposing in principle the construction of BSL4 labs in densely populated areas.

Throughout the last eight years, Safety Net and the Coalition have evolved into a national movement of residents from around the country who are using the Roxbury residents’ community organizing approaches and legal strategies to oppose their BU Biolab.

Inadequate Risk Assessments: the Community Calls BU’s Bluff

In November 2004, the Secretary of the Massachusetts Executive Office of Energy and Environmental Affairs (“EOEEA”) certified that the Final Environmental Impact Report (“FEIR”) prepared by NIH adequately and properly complied with the Massachusetts Environmental Policy Act (“MEPA”). The FEIR erroneously concluded that there was zero risk from the accidental release of inhalation anthrax, while using an unrealistically small number of spores, underestimating their lethality, and failing to account for the greater vulnerability of the elderly, those with HIV/AIDS, the malnourished, and the very young. One month later, in December 2004, the Boston Redevelopment Authority (“BRA”) approved the development plan and the FEIR. Several lawsuits resulted, brought by affected community members with the support of local advocacy organizations and law firms. First, a group of community residents filed suit in Suffolk Superior Court against the BRA and state agencies, asserting that the Secretary’s certification did not adequately comply with MEPA. Second, another group filed a civil action in United States District Court in Boston against NIH for its material violations of the National Environmental Policy Act (“NEPA”). Third, a civil rights complaint under Title VI was filed at the United States Health and Human Services Office for Civil Rights alleging that the proposed location of the NEIDL was discriminatory in that an accidental release would have a disparate impact on those neighboring residents of color whose health and environment were already disproportionately burdened. When the agency did not act upon the complaint, residents filed a lawsuit in federal court to order the Office for Civil Rights to begin investigating the complaint.

The Suffolk Superior Court judge in July 2006 ruled that the Secretary’s certification of the FEIR was “arbitrary and capricious” because it did not comply with MEPA requirements.  Accordingly, he ordered the preparation and review of a Supplemental Environmental Impact Report (“SEIR”) before the laboratory would be allowed to work with BSL4 pathogens. The judges in the other two lawsuits put their cases on administrative hold until the completion of the SEIR. BU appealed. However, the Massachusetts Supreme Judicial Court ultimately upheld the Superior Court judge’s ruling in December, 2007.  Orders in both the federal and the state court also prohibit BU from operating the Biolab without giving advance notice, so that the community can return to Court if necessary.

Meanwhile, in connection with the federal litigation, NIH released a Draft Supplemental Risk Assessment (“SRA”) in August 2007, concluding that the operation of the BU Biolab would not pose a risk to the Roxbury community or surrounding communities. Nonetheless, the EOEEA contracted with the National Research Council (“NRC”) of the National Academies of Science to conduct an independent peer review of the Draft SRA. The NRC concluded that the Draft SRA was not sound or credible, that the worst case scenarios had not been adequately identified, and that the information underlying the alternative site analysis was insufficient or inappropriate. The NRC report not only raised serious doubts about the credibility of the risk assessment process but also provided public confirmation of the validity of the arguments being made by the Coalition’s campaign.

In January 2008, BU and NIH estimated that a new SRA would be completed by April 30, 2009. In March 2008, NIH announced that a Blue Ribbon Panel would be formed to advise NIH in determining the scope of any additional environmental risk assessment that the agency would conduct. The Blue Ribbon Panel would also serve the purpose of advising NIH on best practices for engaging with, and incorporating public comment from the coalition of community groups opposing the laboratory. While the Blue Ribbon Panel has held public meetings in Boston on a number of occasions, opponents of the laboratory have not been convinced that their comments are being heard or given meaningful consideration. Indeed, despite the community’s protests, the most recent meeting was held at the Marriott Copley Hotel, well outside the affected community. In 2007, the Blue Ribbon Panel hosted a meeting in Hibernia Hall in the heart of Roxbury and received an overflow crowd. In order to prevent a repeat incident, the Blue Ribbon Panel decided to have their follow-up meeting elsewhere. While many opponents attended that meeting in the Marriot Copley and provided comments on a large number of aspects of the Biolab, many of the community residents who would be most affected were unable to attend due to the selected location. Furthermore, only three of the eleven Blue Ribbon Panel meetings have taken place in the Boston area. By siting the vast majority of meetings in Maryland, NIH demonstrates disinterest in fully engaging the community.

NIH hired an outside consultant in August 2008, Tetra Tech, Inc., to draft the SRA. The new completion date in the Scope of Work prepared by NIH for Tetra Tech was listed as June 30, 2010. Since that time, the completion date bas been pushed back even farther due to unexplained contract difficulties between NIH and Tetra Tech; the current completion date is set for December 31, 2010.

During this time, BU has completed construction of the Biolab, including the biodefense research facility. Administrative and maintenance staff are on-site, standard operating procedures are being developed, and some training activities are underway. However, no pathogens have been delivered to the laboratory and no research is taking place in the laboratory because the Superior Court order remains in effect, since the Secretary of the EOEEA has neither received nor certified an SEIR, despite waiting for four years for BU to file one. Until BU and NIH complete the SEIR and BU obtains certification from the Secretary of EOEEA, the facility cannot act upon the permits it needs to operate.

BU’s Past Misconduct: BU Cannot be Trusted

The past misconduct of BU demonstrates that it cannot be trusted to operate a BSL4 facility.  In its FEIR, BU represented that it had “thoroughly reviewed” the employee accident records from the last ten years at BSL2 and BSL3 facilities operated by BU and the BU Medical Center.  BU “confirmed that no laboratory-acquired infections from research work in BSL2 and BSL3 laboratories have occurred.” It emerged, however, in January 2005 that three BU scientists had in fact been exposed to tularemia in a BSL2 laboratory in 2004 and had become ill with fever, cough, and headache. BU did not report any of these exposures to the Massachusetts Department of Public Health in a timely fashion. In fact, the information only became public because of local news outlets. Consequently, the initial FEIR Certification, that a judge later vacated, was issued without the Secretary’s knowledge of these tularemia exposures and of BU’s failure to report them in a timely manner. Infections seem to be disconcertingly common at BU, as further evidenced by the recent infection in 2009 of a graduate student with Neisseria meningitidis, a bacterium that causes meningococcal meningitis. The student was working on vaccine research at the time. Further, smoldering medical waste left in a sterilizing machine caused a fire in BU’s BSL3 laboratory in March 2007. BU failed to follow Boston Public Health Commission regulations by not immediately notifying the Commission. The Commission only learned of the fire incidentally.

BU also has a poor track record on the issue of recombinant DNA (“rDNA”). When BU submitted its application to NIH in 2003 for the proposed NEIDL, the community expressed concern regarding the suitability of siting such a lab in Boston due to existing Boston Public Health Commission (“BPHC”) regulations banning the use of rDNA in BSL4 laboratories. This ban bars not only the creation of rDNA molecules, but also the subsequent product and all future replicants of that product. In July 2004, Dr. Mark Klempner, current Director of the NEIDL, wrote a memorandum describing work that he states would be allowed in a BSL4 laboratory under the BPHC regulation. Several scientists in the community examined Dr. Klempner’s suggested set of experiments and concluded that these experiments would in fact be in clear violation of the BPHC regulation. In 2006, the BPHC legal staff conducted a similar assessment of Dr. Klempner’s memorandum and came to the same conclusion as the other scientists – namely, that Dr. Klempner’s stated experiments would, in fact, be in violation of the BPHC regulation. To date, neither BU, NIH, nor the BPHC has addressed this issue.

In addition, BU has not been forthcoming in explaining which agents it will study. Grant applications have been marked confidential with significant portions blackened out, and BU has routinely removed information on its websites detailing the agents on which it will experiment.

Given their extreme lack of care, and seeming inability to prepare a legitimate risk assessment for this facility, BU and NIH have completely lost credibility with the communities that would be affected by the BU Biolab. Certification of NIH’s original FEIR was ruled “arbitrary and capricious.” Leading scientists characterized NIH’s second attempt as neither sound nor credible. With its third attempt, NIH is unable to meet even its own self-imposed deadlines and is having difficulty with the consultant to whom it has outsourced the project. Given this record of ineptitude and NIH’s continued commitment to placing a laboratory that will conduct research on the most dangerous pathogens known to exist, in the heart of a densely populated, low income urban, environmental justice community, the community simply has lost all trust.

Moving Ahead: The Community’s Alternative Vision

Though the community has grave concerns with BU’s current plans for the NEIDL, the community understands the importance of building infrastructure for cutting edge infectious-disease scientific research. As an already at-risk population, they strongly support research and would enthusiastically accept a number of alternative uses for the laboratory. As such, the community has worked with local scientists to develop a carefully crafted proposal for alternative uses for the laboratory space at BU. The community believes that, in addition to benefiting local neighborhoods, the scientific community will be better served by alternative uses. The research currently proposed for the BU Biolab is redundant because of the large number of laboratories already engaged in those areas. Further, as detailed in the attached proposal, the BU Biolab’s emerging disease research focus has minimal value compared to other infectious disease research. The BU Biolab would better serve public health, both locally and overall, if it focused its research on prevalent natural infectious diseases. The NIEDL would also be able to fulfill a vital role in developing counter-measures to bioterrorism agents by employing current “state of the art” vaccine development. The representatives of the community active in opposing the Biolab heartily support the accompanying proposal by numerous scientists for alternative uses of the laboratory that will serve the needs of Roxbury and the scientific community.

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