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BAN LEVEL 4 RESEARCH

We/I, , are/am demanding that all Level 4 Research and Level 3 Category A Select Agent (bioweapons) research be banned in the NEIDL. Instead, the BSL3 laboratory should be restricted to research on natural infectious diseases that present a major public health threat. This call is based on our outrage at the continuing, serious flaws in the risk assessment process . Multiple risk assessments designed to demonstrate that the NEIDL will pose little to no risk to the community have been severely criticized by the courts and by the National Research Council. Ten years later, the risk assessment currently in process has not adequately addressed the problems raised with regards to earlier assessments. In fact, NIH hired contractors, TetraTech and Dr. Adi Gundlappali, to prepare their risk assessment who have no demonstrated experience with this type of research or of risk associated with it. The resulting risk assessment has many obvious omissions of historical data that would have shed negative light on the safety of these labs. The Tetra Tech risk assessment finds no situations where the risk is great enough to disallow research. The impression is that Tetra Tech sees its mission as supporting the opening of all activities in the NEIDL laboratory, no matter what. The current risk assessment fails to: 1. Address the vulnerabilities of the Environmental Justice community surrounding the lab and meet federal and state environmental justice policy standards The NEIDL is located in an area that is a designated Environmental Justice community. The surrounding population

includes a large number of low-income people of color, medically-vulnerable and medically- underserved, who would suffer disproportionate harm in the event of an outbreak from the NEIDL, and will draw no benefit from Level 4 research on exotic pathogens. It was precisely to prevent such blatant environmental racism that President Clinton issued his 1994 Executive Order, directing all federal agencies to provide minority populations and low-income populations the opportunity to comment on the development and design of research strategies. Similarly, the Environmental Justice Policy of the Massachusetts Executive Office of Energy and Environmental Affairs (EOEEA), executed in 2002, requires both enhanced analysis of environmental impacts and mitigation for this project, as well as increased public participation opportunities, because of the NEIDLs location in an environmental justice community. (http://www.mass.gov/eea/docs/eea/ej/ej-policy-english.pdf) Despite these federal and state requirements, the National Institutes of Health has teamed up with Boston University to deliberately mislead the residents, minimize the dangers and bypass community consultation. A prime example of the failure to consider fully the vulnerabilities of the surrounding population is raised by Anne Sheldon, public policy assistant at Rosies Place, a sanctuary for poor and homeless women. In her 5/1/12 comment letter to NIH, she decries the lack of an analysis of the projects impact on Bostons homeless population, noting that there are six shelters that our guests stay at within a 1-mile radius of the Bio-Square Research lab. Further, she points out that Due to homeless individuals transience and greater susceptibility to infectious diseases, their vulnerability is even high than the general low-income population. (See Mel Kings map for locations of the shelters and the many other sites that house at-risk groups within the 1mile radius.)

2. Acknowledge the widespread opposition in the community to this facility Community support is one of the criteria that must be demonstrated in any siting proposal. The residents of Roxbury, Dorchester and other surrounding communities have demonstrated their opposition repeatedly, including overflowing both Faneuil and Hibernia Halls in separate public hearings. At the most recent public hearing on the latest risk assessment, as reported by Global Biodefense, Residents

turned out in force at a NIH-sponsored public hearing on April 19 to comment on the Draft Supplementary Risk Assessment. Most comments were highly negative and charged that the assessment was biased, that the community did not have the capabilities in place to deal with a lab-related emergency and that it was foolish to conduct research on highly contagious and deadly pathogens in such a densely populated location. Within a mile of that area is the largest and busiest bus terminal in the state of Massachusetts, with about 30,000 riders who move through there every single day, said City Councilor Tito Jackson. It scares me beyond no end, and I went through the tour and the tour scared me even more http://globalbiodefense.com/2012/04/23/bsl-4-lab-in-bostonstill-facing-local-opposition/

Arlington, Brookline, Cambridge, Newton and Somerville have all passed resolutions opposing the location of BSL4 labs in densely populated urban areas. The residents of these communities, most of which are more affluent than Roxbury and the South End, would never allow such a lab to be placed in their towns. Cambridge does not permit BSL4 labs anywhere in the city because of their potential dangers. Boston residents deserve the same protection. Further, as Cambridges example shows, prohibiting BSL-4 labs does not discourage medical research or investment by the pharmaceutical industry.

3. Assess adequately the dangers of research with Levels 3 and 4 Category "A" select agents, in particular the potential for a pandemic outbreak Locating the lab in a densely-populated urban area places a vulnerable population at additional risk from accidental releases or intentional actions of malevolent actors. The latest risk assessment does not even once mention laboratory acquired infections, the major route for escape of pathogens from biocontainment laboratories. And the risk assessment downplays the danger that research on live SARS virus could cause a pandemic, even though its own data shows that SARS has the same pandemic-related features as the 1918 pandemic flu virus. As David Mundel has written in his comment letter to the Blue Ribbon Panel, the current draft does not provide any estimate of the total risk to the individuals in the surrounding communities, the risk that might result from

the entire range of possible events that could occur once the NEIDL becomes operational. The authors of this draft appear to be unaware that there is a need to add up the risks associated with even the limited selection of eventpathogen incidents included in the study. They then must estimate the share of the total risk that is accounted for by the limited set of event-pathogen incidents that were included in the analysis. 4. Assess the risks of malevolent acts by rogue scientists or terrorists The risk assessment also fails to look seriously at malevolent actions that could stem from the lab, this, despite the fact that Judge Gants ordered that such scenarios be included in the risk assessment. Tetra Tech states that there is no historical example of a pathogen taken from such a biodefense lab and used for malevolent actions. This ignores the anthrax attacks of 2001, where the FBI concluded that Dr. Bruce Ivins stole anthrax from the Ft. Detrick biodefense lab and mailed them to Capitol Hill and media outlets killing several people and causing billions of dollars in damage. This is just one of several gross omissions, which also include the 9000 samples of pathogens reported missing from Ft. Detrick, as well as the anthrax release from a biodefense lab in Sverdlovsk, Russia that killed approximately 70 people. The key finding of the May 2009 report of the Department of Defense Task Force Report on Safety and Security techniques in BSL-3 and BSL-4 labs (http://www.acq.osd.mil/dsb/reports/2009-05Bio_Safety.pdf) in handling of BSATs (Biologic Select Agents and Toxins) reinforces the idea that individual actions are the key danger in these labs. Any credible risk assessment cannot ignore this. Noted criminologist Prof. James Alan Fox identifies the impossibility of estimating the likelihood of malevolent acts as the fatal flaw in the risk assessment. In a blog post, he notes but the coverage of so-called malevolent acts is questionable, at best, having been grounded in unsupported assumptions concerning the likelihood of such misdeeds. While one may calculate the probabilities of certain calamities, the likelihood of a terrorist mission targeting the facility or of a disgruntled employee intent on sabotage is inestimable. No one

can say with any degree of certainty whether they will come,-- whether launching Level 4 research activities will be irresistibly attractive to intruders or insiders wishing to create havoc by releasing pathogens into a highly congested area. BU scientists may wish to experiment with dangerous biological agents, but they shouldnt experiment with the safety and well-being of the millions who live or work in the surrounding area. (boston.com's Crime and Punishment blog, April 24, 2012 5. Assess the ability of first responders to confront an accidental release The Massachusetts Nurses Association (MNA) has taken a position in strong opposition to the siting of the lab on the BMC campus (www.massnurses.org). Nurses have repeatedly emphasized their concerns about the lack of emergency preparedness plans in Boston and the Commonwealth which limits the ability of not only Roxbury but the city of Boston to recover from a major laboratory-generated crisis . MNA notes that its BMC nurses and other healthcare providers are not prepared to handle emergencies connected to a release of a Level 4 pathogen. Staff have not been trained to deal with such biological agents, the vast majority of which are used only in biowarfare. These are not viruses and bacteria that cause strep throat or bellyaches. These are deadly agents, most with no known cures. The lab work requires stripping, suiting up in individually fit-tested garments with selfcontained breathing apparatus, special boots and gloves which are seam-sealed with tape. Many people cannot wear the apparatus; fire departments often find workers become too claustrophobic to suit up. Once suited, wearing oven-mitt like gloves and goggles, it would be virtually impossible to actually provide care to patients. Moreover, by the time it is obvious that a plague or Ebola patient has arrived, it will be too late for doctors or nurses to attempt to suit up. The genie will be out of the bottle. Entire hospitals had to close during the SARS epidemic, and hospital staff were quarantined. Hospitals across the state have not been able to get their staff trained or their facilities equipped to meet the demands of an epidemic of massive proportions such as a breach of the BU biolab might cause.

BU has already had multiple accidents at its other laboratories where

staff have not been made aware of the dangerous exposures they faced. Boston firefighters were contaminated with radioactive isotopes, with injured firefighters brought into BMC for treatment without the emergency room staff being notified of the potential danger to them. http://www.radjournal.com/news/radiation/peblaze.htm. The cause of the 2004 tularemia infection of 3 BU researchers has never been determined. In a scathing report examining the exposure of three Boston University researchers to tularemia last year, Boston public health authorities yesterday called on BU to strengthen internal oversight of safety in medical school laboratories. See: http://www.boston.com/news/education/higher/articles/200 5/03/29/city_tells_bu_to_bolster safety_of_its_medical_labs/.

To this day, a decade after 9/11, there is no Massachusetts Emergency Preparedness plan. Hospital emergency rooms are flooded on a daily basis with patients awaiting care; psychiatric patients and the homeless live in emergency rooms for days at a time awaiting placement. The citys medical establishment is dealing with a lack of capacity and resources on a daily basis and the very last thing the city or state, known as being a medical mecca, needs is for another serious laboratory accident to cause an uncontainable life-threatening outbreak in the city.