Biosafety lapses prompt govt. review

Following a spate of safety lapses, universities are tightening oversight of research into potentially dangerous biological agents as Congress prepares to conduct a hearing into bioterror research programs, many of which were funded following the Sept. 11, 2001 attacks on the US.Problems at university labs in Texas and Wisconsin have raised concerns that research designed to protect the public's health may, ironically, increase the possibility of accidental, or deliberate, exposure to harmful biological agents."Unless there is perfect security there are risks that these pathogens could be released into the community, workers could be exposed to them, or that these pathogens could be stolen," said Barry S. Levy, adjunct professor of public health at Tufts University School of Medicine and coauthor of Terrorism and Public Health. A Balanced Approach to Strengthening Systems and Protecting People. The safety concerns prompted congressmen John D. Dingell (D-MI), Chairman of the House Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the House Subcommittee on Oversight and Investigations, to schedule an Oct. 4 hearing on safety level III and IV laboratories. The committee will seek testimony about the number of labs operating, employee training and the structure of government oversight over biodefense labs."It appears that there has been a surge in construction of biosafety labs over the past several years which have been financed, at least in part, with federal funds," said Dingell in a statement. "While the research conducted at these labs is certainly valuable, we must make sure that it does not pose a risk to the public health."In the most serious incident, several workers at Texas A&M were exposed to Brucella and Coxiella burnett in March, 2006. The university's director of research resigned on August 31, after the Centers for Disease Control and Prevention (CDC) halted the research until the university could prove it has corrected the problems.Last week, following an NIH inquiry into 13 laboratory incidents at the University of Texas at Austin, the university announced it would ramp up training, establish a rapid response team for laboratory incidents, add staff to its Institutional Biosafety Committee (IBS) and conduct a review of its research management structure and research data.Harold Davis, associate vice president for research at the University of Texas at Austin, noted the problems did not involve substances classified as hazardous by CDC guidelines. "We're trying to create a culture in which we can communicate and have better follow-up to make sure we can do the best we can when things happen," Davis told The Scientist , adding that the university has more than 1,000 labs. "We're human. Things will happen."The Sunshine Project, a biosafety and armament watchdog group based in Austin, reported incidents at two other University of Texas schools earlier this year. The incidents had been reported to the CDC as required and no infections occurred, although some workers received antibiotic treatment. The group also disclosed last week that researchers at the University of Wisconsin in Madison made and manipulated copies of the Ebola virus genome in a level III lab when the work should have been done at level IV. The inquiry identified similar concerns about research into Ebola and Lassa Virus DNA at Tulane University.Terry Devitt, spokesperson for the University of Wisconsin at Madison said the Ebola researchers were not attempting to skirt regulation. Indeed, he said, the problem came to light when the university itself sought to move work to a level II lab. The research has since moved to a collaborating laboratory in Canada.Tulane officials told The Scientist in an Email that researchers there are in full compliance with federal safety regulations and are not using any material that could replicate Ebola or Lassa viruses.The CDC has conducted biosafety risk assessments of more than 14,000 lab workers and has registered about 400 separate laboratory locations for inspection under the agency's 2003 rules governing potential bioterror hazards.Edward Hammon, director of the Sunshine Project's US office, said he believes many emerging safety problems stem from a fractured regulatory system that includes the CDC and NIH, but also the Department of Defense, the Occupational Safety and Health Administration and other agencies "We need to eliminate some of the conflicts and reduce some of the overlap and bring it together under a unified type of authority."David Ozonoff, a professor of environmental health at the Boston University School of Public Health who opposes construction of a much-debated level IV lab at his university, said the dangers of bioterror research already outweigh the chance it will protect public health. He also said he is concerned research into bioterror agents could become a signal to enemies, and allies, that the US is engaging in research into offensive bioterror weapons. As a result, he argues, the research could stimulate a dangerous global biological arms race.Ozonoff said researchers are now masking research into diseases like Ebola as defense projects, because in the post-Sept. 11 environment funding for such work is plentiful. He added that when research into disease shifts from the public health to the defense environment it becomes classified and unavailable to other scientists. "Classified research is automatically not public health. The minute it is classified it is no longer of scientific merit."Susan Warner mail@the-scientist.comLinks within this articleA. Katsnelson, "Texas universities bombing biosafety?" The Scientist , September 19, 2007. http://www.the-scientist.com/blog/display/53600/A. Katsnelson, "Biosafety concerns at U of Wisconsin Ebola lab," The Scientist , September 20, 2007. http://www.the-scientist.com/blog/display/53604B. Levy and V. Sidel, Terrorism and Public Health A Balanced Approach to Strengthening Systems and Protecting New York: Oxford University Press, 2007) http://www.oup.com/us/catalog/general/subject/Medicine/PublicHealth/?view=usa&ci=9780195158342
John D. Dingell http://www.house.gov/dingellBart Stupack http://www.house.gov/stupakNews Release: US House of Representatives' Committee on Energy and Commerce, August 9, 2007 http://energycommerce.house.gov/Press_110/110nr57.shtmlThe Sunshine Project http://www.sunshine-project.org/J. Dudley Miller, "NIH OKs embattled Boston biolab," The Scientist February 3, 2006. http://www.the-scientist.com/news/display/23076/

Biosafety lapses prompt govt. review

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