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DANIEL GOODENOUGH AND DAVID OZONOFF

BU's biolab and the law

IN RESPONSE to the laboratory outbreak of tularemia at Boston University Medical School in 2004, the Boston Public Health Commission has recently proposed an extensive set of laboratory regulations for the city. Questions can be raised as to whether these regulations are strong enough and whether they ensure sufficiently independent oversight, but the commission is to be commended for keeping in place longstanding regulations governing laboratories in Boston.

In 1994, the Boston Public Health Commission adopted regulations banning the use of recombinant DNA techniques -- genetic engineering in popular parlance -- within Biosafety Level-4 laboratories. These regulations were adopted out of health and safety concerns. Recombinant DNA research on pathogens is risky, since scientists cannot always predict what will result from their experiments in genetic engineering.

The risks are especially pronounced for recombinant DNA research performed in BSL-4 laboratories. Those laboratories are reserved for the most dangerous and most exotic pathogens, which can be transmitted through the air, are nearly always lethal, and for which no vaccines, no drugs, or other countermeasures exist. The disasters that could result if super versions of already lethal bugs were accidentally released in the city of Boston need no elaboration.

The anthrax mailings of 2001 highlight the additional possibility of deliberate release by a disturbed, disgruntled, or extremist laboratory worker. The mailings underscore the fact that threats may come from ''insiders" and can be difficult to prevent.

The 1994 ban on this dangerous research is relevant now as Boston University plans to build a BSL-4 laboratory in the South End. Given that recombinant DNA techniques are essential tools for research in modern biology, how can the facility conduct scientific work that does not violate the 1994 Public Health Commission ban?

Boston University has recognized this dilemma. In a July 2004 statement, Dr. Mark Klempner, associate provost for research at Boston University Medical School and the principal investigator at the BSL-4 facility, wrote: ''The regulation prohibits attempts to efficiently make fully virulent risk Level 4 organisms more virulent and more dangerous. It was not intended, in spirit or letter, to deter legitimate research." In short, he has declared that the recombinant DNA research to be performed in the Boston University lab will be ''legitimate research" and has asserted that, as ''legitimate research," it will be exempt from regulation.

Klempner's position is without basis. The wording of the 1994 Public Health Commission ban is concise and straightforward: recombinant DNA ''requiring containment defined by the [NIH] guidelines as 'BL4' [today known as BSL-4] shall not be permitted in the City of Boston."

The 1994 Public Health Commission ban draws no distinctions between legitimate and illegitimate research. It makes no judgments on the value of recombinant DNA research in BSL-4 labs. It simply outlaws such research within the city's limits in order to protect public health and safety in a densely populated urban area.

The existing ban on recombinant DNA research in a BSL-4 lab in Boston must be upheld. This same restriction is in place in Cambridge. We must not sacrifice public safety for researchers pushing their own agendas. We urge Mayor Thomas M. Menino and city councilors to follow the guidelines put in place by the Public Health Commission.

Daniel Goodenough is a professor of cell biology at Harvard Medical School. Dr. David Ozonoff is a professor of environmental health at Boston University School of Public Health. Also contributing to this piece were Richard H. Ebright, a professor of chemistry at Rutgers University, and Lynn Klotz, a senior science fellow at the Center for Arms Control and Nonproliferation.

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