By George Miller
A government report has resorted to Cold War language and imagery: High-Containment Biosafety Laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States. The term “proliferation” reeks of the arms race of a generation past, and has added oomph from its use in describing rapid growth and production in cell processes.
Beyond its title, the report invites Cold War comparisons in its out-of-our-hands explanation for why such facilities are difficult to count: “We found that the total number depended upon how you ask the question. Most often data were available on the number of facilities or sites that contained a BSL-3 or BSL-4 lab. The precise number of independent rooms within those facilities qualifying as BSL-3 or BSL-4 is not generally specified…. Experts also told us that counting the number of labs is problematic because the definition of the term ‘lab’ varies.”
The report, authored by Keith Rhodes, chief technologist in the U.S. Government Accountability Office, as testimony for hearings conducted in early October by the Congressional energy and commerce committee, is having its intended effect: “Do we really need 12 laboratories that operate at the very highest level of security? Is there a good reason for creating these labs, or have we simply begun an arms race against ourselves?” asked committee chair Rep. John Dingell (D-Mich.) in a statement after the hearing.
The hearings are a result of Congress approving large amounts of biotech research funding for terrorism and pandemic preparedness following the 9/11 and anthrax mailing attacks of 2001 and the SARS outbreak of 2003, and then in after-the-horse-escapes fashion realizing that some kind of oversight of the work is required.
In fact, oversight has existed for years. The National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), acknowledges its responsibility for the facilities that house the substantial amount of research that it funds. “Support for infrastructure…is essential if we are to fulfill our biodefense research agenda,” said Hugh Auchincloss, M.D., principal deputy director, in testimony. He cited recent advances—including leading-edge smallpox, anthrax, and Ebola virus vaccines—that required the use of such high-containment facilities.
Auchincloss said that NIAID works closely with each grant recipient to ensure that new labs are designed and constructed to the highest standards. NIAID staff architects and engineers work with contract construction quality management groups having additional expertise. “These teams make certain that the finished projects will meet the regulations of the Centers for Disease Control and Prevention (CDC) and the Department of Agriculture’s Animal and Plant Health Inspection Service for facilities that conduct research on select agents.”
Auchincloss added that NIH is committed to ensuring that the research conducted within the facilities is performed safely. “The most widely used guidance on the safe conduct of this research is the Biosafety in Microbiological and Biomedical Laboratories Manual (BMBL), which is now in its fifth edition and available online.”
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In 2002, NIAID determined that the BSL-3 or BSL-4 research space available was inadequate for its academic scientists conducting extramural research. Auchincloss said that the Institute estimated the new BSL-3 and BSL-4 facilities that would be required, and that Congress responded quickly with the necessary resources.
The National Institutes of Health is now implementing a construction program that will complete 14 new BSL-3 facilities and four new BSL-4 facilities within the next few years, said Auchincloss. “During this process, the NIH or its funded institutions have participated in literally hundreds of public forums on the nature and safety of the new facilities, and have submitted reports to Congress annually, along with periodic updates on our strategic plans. In addition, NIH leadership has discussed the infrastructure expansion with Congress on many occasions,” he said.
The public forums, reports, and discussions are all helping to raise issues that need to be addressed concerning germ containment and safety protocols in the post-Project Bioshield era.
Just ask the people who live adjacent to a BSL-4 facility being constructed at the Boston University Medical Campus. A neighborhood group has opposed the facility at most steps along the way [see “Transparency is Key to Neighborhood Acceptance of Biosafety Labs,” CleanRooms magazine, July 2007, p. 8] and is currently aligned with the Conservation Law Foundation in efforts to slow or halt facility construction.
The group maintains an issues-based web site that in early November carried a news article, “Mishandling of Germs on Rise at US Labs,” by Larry Margasak of the Associated Press, as its lead story. Margasak reviewed reports submitted to federal regulators and concluded that “American laboratories handling the world’s deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing as more labs do the work.”
And if that weren’t enough to put the neighbors on high alert, a centerpiece of the GAO testimony provided detail of just how easily such mishandling can occur even by lab workers with the best intentions.
At Texas A&M University, according to the testimony, a lab worker was unknowingly infected with the Brucella bacterium after being enlisted to help operate an aerosolization chamber in a BSL-3 lab. The worker was the director of a BSL-2 lab and experienced in handling the infectious agent Mycobacterium tuberculosis. In testimony, Rhodes postulated that her M. tuberculosis experience might have provided a false sense of security:
“Typical routes of infection differ between M[.] tuberculosis and Brucella and normal procedure, including gowning and respiratory equipment, vary between the two agents. For example, the lab worker wore protective glasses, but they were not tight fitting. This was adequate when working with M[.] tuberculosis, but not with Brucella.”
The investigation concluded that the lab worker contracted Brucella through her eyes. More than six weeks passed before she fell ill, and only after symptoms persisted did she consult with an infectious disease specialist, leading her to recall the Brucella work. Although she got quite sick, she eventually resumed her normal activities while infected.
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“Such misdiagnosis is not uncommon with infectious diseases, as the initial symptoms often appear flu-like and brucellosis is not generally endemic in the population,” said Rhodes.
He adds that there are risks in working alternately in BSL-2 and BSL-3 labs, with their different levels of procedures and practices. “The fear is that lab workers may develop a routine with BSL-2 procedures that might be difficult to consciously break when working with the more dangerous agents and activities requiring BSL-3 containment.”
Rhodes’s warning provides yet another red flag to the neighbors of the BU Medical Campus, many of whom still recall the 2004 incident at a BSL-2 facility there that resulted in the infection of three researchers with tularemia. The infections stemmed from a violation of safety procedures and most likely have done much to solidify neighbors’ resolve against the BSL-4 facility. As this issue went to press, both BU officials and neighbors were awaiting results of an environmental impact study by the National Research Council, commissioned by the State of Massachusetts, which is to include a worst-case scenario assessment. Results were due at the end of November.
Editor’s note: See CleanRooms’ January 2008 issue for a follow-up on the National Research Council’s findings and their anticipated impact on the management of biosafety facilities.