Boston to regulate research

The City of Boston will likely soon approve plans to regulate research in all Biosafety Level 3 and 4 labs inside city limits, according to a senior Boston public health official. The comprehensive and controversial draft regulations are seen as a response to concerns about the safety of past and future biological research at Boston University. If they are adopted in the next two months as expected, Boston will become the first major city in the U.S. to monitor research in universities, hospitals and private labs, according to the city's public health chief, John Auerbach. The proposed regulations would require that all BSL-3 and BSL-4 labs, plus BSL-2 labs working with attenuated strains of high-risk viruses, apply for operating permits. The federal government defines BSL-4 labs as those that work with incurable diseases and BSL-3 labs as those working with agents that may cause serious illness and possible death. Under Boston's proposed regulations, city officials would set training standards and would regularly inspect those labs, with no prior notice needed. In addition, institutional biosafety committees mandated for all labs would be required to include two community representatives, one approved by the city, and to meet at least twice a year, once in public. Classified research and research to create bioweapons would be banned, and whistleblowers would be protected from retaliation. Violators could be fined $1,000 per day and lose their permits. Several affected institutions are actively opposing all or part of the proposed regulations, including the Massachusetts Biotechnology Council, pharma giant Merck and Co. and Harvard University. Many opponents have complained that the regulations would force them to publicize intellectual property that competitors, activists and even terrorists might use to their own advantage. In a July letter to Auerbach, the MBC warned that the regs "would severely limit, not support, the growth of biopharma in Boston."Richard Ebright, a Rutgers University professor, doesn't buy the confidentiality complaint. Universities and corporations already routinely review planned and in-progress research "without issues involving breach of confidentiality," he told The Scientist.Edward Hammond, who has analyzed the minutes of IBC meetings nationwide for the Sunshine Project, a bioweapons monitoring group, agrees. "The overwhelming proportion of the business of biosafety does not involve security-sensitive information," he said, and the "tiny fraction" that does can be withheld without anyone objecting.Many community activists believe that Boston's recent history proves the regulations are needed. BU has been a lightning rod for criticism ever since the National Institute of Allergy and Infectious Diseases awarded the university about $128 million in 2003 to build a seven-story, combined BSL-2, -3 and -4 lab in one of Boston's poorest neighborhoods, the Roxbury-South End area. In April 2004, 146 Massachusetts professors sent a letter to the mayor and BU's trustees saying that the neighborhood was too congested to allow research on incurable BSL-4 diseases like Ebola virus. Two days later, BU ran full-page newspaper ads listing 330 scientists supporting the lab.Community opposition to the lab increased in January 2005, when news broke that three BU researchers had infected themselves with tularemia and that BU didn't inform the Boston Public Health Commission until six months after the first two infections. Eugene Benson, staff attorney for Alternatives in Community and Environment, a Roxbury activist group that opposed the BU lab, said the new regulations will fill a critical gap "because there is no comprehensive federal or Massachusetts regulatory program for BSL-3 and -4 laboratories." Ebright also noted the dearth of meaningful federal regulation. "There are no - zero -binding federal regulations on biosafety," he said, just unenforced guidelines that apply only to laboratories that work with select agents or perform rDNA research with National Institutes of Health funding. Mandatory regulations that do exist for select agents concern biosecurity, he said, not biosafety. Kristin Golden, director of policy and planning for the BPHC, told The Scientist that the proposed regulations are currently being revised in response to feedback, but that she expects the commission will approve them in the next 60 days. John Dudley Miller jmiller@the-scientist.comCorrection: When originally posted, this story incorrectly stated that the City of Boston would appoint community representatives to biosafety committees, rather than simply approve the appointments. In addition, the story did not make clear that there are mandatory federal regulations about working with select agents, just none about biosafety. The Scientist regrets the errors. Links within this article Boston Public Health Commission, "Biological laboratory regulations," June 14, 2006. http://www.bphc.org/board/pdfs/labdraft061306.pdfThe Sunshine Project http://sunshine-project.org/"NIAID funds construction of biosafety facilities," NIAID press release, September 30, 2003. www2.niaid.nih.gov/Newsroom/Releases/nblscorrect21.htmJ.D. Miller, "Sparks fly on Boston lab plan," The Scientist, May 5, 2004. http://www.the-scientist.com/article/display/22154/Boston Public Health Commission, "Report on pneumonic tularemia in three Boston University researchers," March 28, 2005. http://www.bphc.org/reports/pdfs/report_202.pdfEugene Benson, Staff Attorney, Alternatives for Community and Environments http://www.ace-ej.org/staffandboard#EB

Boston to regulate research

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