Original article from: Health Day posted on July 22, 2015. by Randy...
BU Questions Claims Behind Ordinance to Ban BSL-4 Research: City Council Hearing on April 16
Boston City Councillor Charles C. Yancey recently filed a proposed ordinance to prohibit Biosafety Level-4 (BSL-4) research in the City of Boston, based on the Councillor’s belief that conducting BSL-4 research is unsafe for the community.
Councillor Yancey’s proposed ordinance is unnecessary. An exhaustive study of the safety of the Boston University biosafety lab has been conducted and reviewed by outside experts. This analysis, titled the Final Supplementary Risk Assessment (FSRA), concluded that operating a BSL-4 lab in Boston’s South End would be safe. We would like to briefly summarize that safety assessment and also correct several errors and misstatements in the Preamble to Councillor Yancey’s proposed ordinance.
Regarding the safety of BU’s biosafety lab (which is called the National Emerging Infectious Diseases Laboratories, or NEIDL), an in-depth analysis has evaluated how conducting BSL-4 research in Boston’s South End might pose a risk to the local community. The study was sponsored by the National Institutes of Health, was conducted by an independent company that specializes in risk assessment, and was overseen and critiqued by two separate panels of independent scientific experts. The study took nearly four years to complete. It came to the conclusion that an event causing an infection of a community member might occur no more than once in 500 to 10,000 years. View a synopsis of the FSRA.
The panels of scientific experts concluded that this was “the most scientifically sound and rigorously conducted study that is possible at this point.” Chief United States District Judge Patti B. Saris also evaluated the risk assessment (FSRA). She concluded: “…the Court is satisfied that the FSRA adequately analyzes the risks associated with building the BioLab, including ‘worst case’ scenarios and suburban and rural alternatives. The NIH provides sufficient scientific support for its ultimate conclusions that the risks to the public are extremely low to not reasonably foreseeable, and the differences between the Boston location and the suburban and rural sites are not significant.”
Real-world experience with BSL-4 research labs confirms that they are safe. There are 10 BSL-4 facilities in operation in the United States. With over 100 years of cumulative operation and hundreds of thousands of man-hours of research, there has never been any laboratory-acquired infection or community infection by such organisms. That track record is also proof that you don’t need to ban something to make it safe. You need ongoing, stringent, and independent regulation to do that. The BSL-4 research in the NEIDL will be under the surveillance of the Boston Public Health Commission, the United States Centers for Disease Control and Prevention, and the National Institutes of Health.
A hearing to consider Councillor Yancey’s proposed ordinance is scheduled for April 16. Boston University looks forward to appearing at the hearing to share information about BSL-4 laboratories and to respond to any or all concerns the Council may have about such facilities operating in the city.
In advance of the hearing, however, we wish to set the record straight and correct a number of misstatements and falsehoods contained in the preamble to the Yancey Ordinance. We hope you’ll take a few minutes to read the following corrections, and if you have any questions, feel free to contact us through our community relations staff members Valeda Britton (firstname.lastname@example.org) or Chimel Idiokitas (email@example.com). Thank you for taking the time to read this.
An ordinance offered by Councillor Charles C. Yancey Regarding the Prohibition of Research Designated as Biosafety Level 4 (BSL 4)
Whereas: Boston University Medical Center has submitted a proposal to the U.S. National Institutes of Health for $1.6 billion in federal funding over the next two decades to build a bio-terrorism defense research facility on Albany Street in the South End of the City of Boston;
The fact is, Boston University has not submitted a $1.6 billion, 20-year funding request, nor would the NIH accept such a request if one were submitted. The lab was built at a cost of $192 million, 75% of which was provided by the NIH. Once the Level-4 lab is open, the University must annually apply for operating grants to partially fund the operation of the BSL-4 facility and compete for Principal Investigator–generated grants to conduct specific research within the facility.
It is disingenuous to label the facility as a bioterrorism facility; it is not. Simply put, it is a biocontainment facility that was built to carry out the mission of the NEIDL: to identify new ways to diagnose, treat, and cure emerging infectious diseases in a safe and secure manner.
Whereas: the proposed network of laboratories will be designated to function and research at Biosafety Level 4 (BSL 4), a level of security designed for research on the most dangerous and exotic categories of disease causing organisms; and
Whereas: disease-causing organisms used in BSL 4 laboratories include viruses such as Ebola, Marburg, Lassa, Machupo, Smallpox, and several other forms of viruses that cause Hemorrhagic Fever, some of which have no known cure;
The fact is, it is true that we will study BSL-4 organisms at the NEIDL, and the lab has been built to the highest possible level of security and safety as a result. However, we will not be conducting research on smallpox, which is the most highly contagious of the BSL-4 organisms. It is illegal to conduct smallpox research in the United States with the exception of the CDC lab in Atlanta, Georgia. Moreover, the preamble fails to mention that most of the other BSL-4 organisms, while potentially deadly if contracted, are transmitted only by contact, and are not known to be transmitted through the air. To “catch” these diseases, a person normally has to be exposed to the bodily fluids of a patient who is in a later stage of the disease. Given that fact, and the safeguards built into a BSL-4 laboratory, the public health risk is minimal. Indeed, the most extensive, up-to-date scientifically sound and rigorous modeling of the spread of BSL-4 agents can be found in the Final Supplementary Risk Assessment for the NEIDL. The Final Supplementary Risk Assessment for the NEIDL took nearly four years to complete, was independently reviewed by two highly esteemed independent scientific panels, and is the most extensive and scientifically sound analysis of risk ever done for a biological containment laboratory in the United States. It considered hundreds of possible scenarios that could potentially result in an exposure of a worker to a pathogen, or the release of a biological agent. This Risk Assessment demonstrated conclusively that BSL-4 laboratories—built with multiple backup redundancies for its operations systems—are extremely safe, both for the laboratory worker (who is at the greatest risk) and for the surrounding community.
Whereas: these disease-causing organisms may be used as agents in weapons of biological warfare and have been termed by President George W. Bush as Weapons of Mass Destruction (WMD);
The fact is, BSL-4 organisms are not weapons of mass destruction. They are naturally occurring diseases for which we propose to find cures. The NEIDL will neither “weaponize” these organisms nor will we conduct classified research on them. Indeed, it is illegal to develop weapons of mass destruction. While it is provocative to raise the specter of using a lab to work on WMD, it is also completely false insofar as the NEIDL is concerned.
Whereas: there are four Bio-safety Level 4 facilities in the United States: none of which are located in concentrated urban areas;
The fact is, there are 10 BSL-4 labs in the U.S., 5 of which are located in urban areas—Atlanta (2), Galveston (2), and San Antonio (1). Through over 100 years of collective operation and hundreds of thousands of man-hours of research, there has never been a release of a BSL-4 organism into the surrounding community, nor has any lab worker or member of the public been infected by such organisms. Moreover, urban locations for these facilities are seen as an advantage for public health and safety because of the proximity and access to highly skilled research workers and state-of-the-art medical facilities, as well as rigorously trained first responders.
Whereas: each of these facilities is under full military protection and control to prevent attack on the facility or the stealing of such agents, as occurred at the defense laboratory in Detrick, Maryland, where a scientist stole anthrax that he then mailed in September 2001;
The fact is, with the exception of Ft. Detrick, which happens to be located on a military installation, none of these facilities is under any military control whatsoever. In Boston, Boston University controls the facility and operates it under procedures established by our own research experts as well as the CDC, NIH, and the Boston Public Health Commission. Boston University protects the facility with its own specially trained public safety officers, and we conduct frequent, joint training exercises with police, fire fighters and EMTs from the City of Boston, and public safety officials from the Commonwealth of Massachusetts.
Whereas: analysis of modeling systems at the United States Army and the Federal Emergency Management Agency indicate a ten- to twenty-mile downwind dispersion radius in the case of an accidental or intentional release of biological agents contained at the Boston University facility;
The fact is, neither the Army nor FEMA has ever studied the BU facility or conducted a “dispersal” analysis. The independent studies which have been done concluded that BSL-4 organisms are not easily spread through air and downwind drafts, and that the likelihood that a member of the public might be infected as the result of a release is “vanishingly small.” These studies have been conducted by independent scientists from across the country and the results have been examined and accepted by the city, state, and the federal district court.
Whereas: there are at least four ways for the biological agents to be released:
- An accident during the transportation of the biological agents to the site;
- A breakdown in security as occurred in December 2002 at an infectious disease laboratory at Plum Island, New York, where a three-hour total power failure undermined the containment system of the biological agents;
- An infection of workers as occurred at the Center for Disease Control in Atlanta where two workers died in 2001 after being exposed to strains of meningitis bacteria that was the subject of their research; and
- An intentional release of the biological agents as occurred with the September 2001 release of the anthrax strain or through attack.
The fact is, these statements are false, misleading, or grossly overstated.
- The transportation of BSL-4 organisms is tightly controlled and BU has worked closely with city, state, and federal authorities to ensure that our transportation plan complies with all regulations. In fact, in response to public concern, Boston University has enhanced its transportation plans to exceed the standards of all other BSL-4 facilities. Moreover, in the event of an accident, BSL-4 organisms are unlikely to infect people nearby. The quantity of material shipped at any one time is minuscule, approximately the size of a thimble. The packaging creates an airtight seal around the organisms and provides several layers of shock absorption to prevent any break. Also, if a spill were to occur, the BSL-4 organism will not infect anyone unless it is somehow transmitted through a transfer of body fluids—a most unlikely scenario in the case of a transportation accident.
- Plum Island is an antiquated facility scheduled to be shuttered. The NEIDL is a new facility built to the highest possible standards of BSL-4 safety. Any comparison between the Plum Island facility and the NEIDL is deceptive.
- The CDC incident did not involve a BSL-4 laboratory, and the strain of meningitis in that case is commonly found in the upper airways of many healthy people.
- The September 2001 release involved anthrax that had been weaponized and made “air-borne.” We will not be “weaponizing” any organism at the NEIDL, anthrax or otherwise. It is illegal to do so. Instead, we’ll be looking for ways to cure diseases—and mitigate the effects of new infectious diseases that have the potential to cause worldwide pandemics—through the development of vaccines, diagnostics, and therapeutics to treat people who succumb to these agents.