City cuts back on plan to regulate biolabs

In the face of opposition from Harvard University, pharmaceutical giant Merck & Co., and the state biotechnology industry, Boston is scaling back its pioneering plan to regulate research on infectious organisms in laboratories within city limits.

The regulations, proposed last November by the Boston Public Health Commission, would have required a city permit to conduct research on any organisms that could be infectious, opening up to public scrutiny a significant amount of research done by hospitals, universities, and drug companies.

But since the draft regulations were first issued, biotechnology companies and scientists at medical labs in the city have been chafing at what they consider overly strict requirements that could expose the nature of their research to activists, competitors, and even terrorists.

In letters and public statements reviewed by the Globe, as well as in private meetings with city health officials, the Massachusetts Biotechnology Council , Harvard Medical School , the city's hospitals, and biotech companies have lobbied the Public Health Commission to let them keep their work confidential.

``Whether you're doing cutting-edge research or developing a new product, usually it's done under wraps until the final thing is ready," said Andrew Levin , chief executive of Immunetics Inc. , a small Boston company that makes kits to diagnose infectious diseases.

If the rules are adopted, Boston would become the first major city in the United States to monitor hazardous biological research inside hospitals, medical schools, and private companies.

They were drawn up in response to safety concerns about Boston University's plans to study some of the world's most dangerous organisms in a $178 million federally funded biosafety lab it is building in the South End. Neighbors' fears were stoked when a group of researchers at another BU lab became sick in 2004 after exposure to the bacteria tularemia. Until the university disclosed the accident, city officials had not known the researchers were working with the highly infectious agent.

The city's permit proposal requires researchers to submit a list of potentially dangerous viruses and bacteria in their labs, and to hold annual public meetings to detail their work.

In its original version, the regulations applied to all labs working with potentially infectious agents. After the draft regulations were released, medical researchers and the biotechnology industry immediately pushed back, saying monitoring of most low-level infectious agents would create a blizzard of paperwork for no appreciable public health benefit.

A revised version of the regulations, released in June, eliminates the permit requirement for most labs. It requires permits for the relatively small number of labs doing work at biosafety level 3 and 4, the two most secure ``containment levels" defined by the US Centers for Disease Control and Prevention. It would also require permits for a handful of lower-security labs working with weakened versions of dangerous agents such as anthrax. But permits would not be required for the other labs at biosafety level 2, which the city counts in the thousands and which handle infectious organisms not considered an immediate public hazard.

The rules are still under consideration by the health commission, which will forward a final recommendation to the city's board of health in the next two months.

Researchers and companies have also pressured the city on other issues, including a rule that would let the health commission seat a community member on each institution's internal biosafety committee. Community groups have also weighed in, asking the city to closely monitor research on extremely dangerous agents, or ban it entirely.

The debate over Boston's biosafety regulations highlights the tangle of rules and guidelines that govern research on infectious organisms.

Medical research on anthrax, influenza, and other disease agents has accelerated in recent years, fueled by concern over bioterrorism and pandemic disease. But to a large extent, the universities, hospitals, and companies that work with infectious agents have been expected to police themselves.

``There is no federal or state comprehensive oversight of health or safety in these labs," said Eugene Benson , a lawyer with Alternatives for Community and Environment , a group that is pushing for stricter public oversight. ``The way you make sure the work is being done with appropriate safeguards is not to hide it."

For anthrax, Ebola , and a short catalog of dangerous pathogens, the federal government demands strict secrecy and careful handling. The BU biosafety lab under construction in the South End will be one of only a handful in the country licensed to work with those agents in their most dangerous forms, and some university researchers have said that city disclosure requirement would force them to break federal confidentiality rules. The city health commission says its lawyers are working with federal officials, and that the final regulations will be compatible.

As Boston's Public Health Commission has wrestled with the regulations, it has found itself trying to balance the community's interest in being informed with researchers' concern for their own safety and confidentiality.

``If you assume that some stuff [in the labs] might be dangerous, you don't want to provide road maps of where certain things are," said Kevin Casey , a government affairs official at Harvard University.

Beyond the safety question, the biotechnology industry is also concerned that the rules could send a message that Boston isn't friendly to business. Thomas M. Finneran , president of the Massachusetts Biotechnology Council , calls the rules a ``worrisome development" that could discourage businesses from opening or expanding in Boston, especially if they are worried their trade secrets would be revealed in public meetings.

With just a handful of biotech companies, the city is a less significant player in the industry than neighboring Cambridge, but Boston Mayor Thomas M. Menino has tried to cultivate life sciences companies.

The best-known private research lab in Boston belongs to Merck, the multibillion dollar drug maker that employees 200 people in the Longwood Medical Area and is planning to expand to 500. Merck's arrival in 2004 was considered a major success for Menino.

Merck has not commented publicly on the proposed regulations but worked closely with the Massachusetts Biotechnology Council to develop the council's position. Company representatives have also attended several public health meetings, said John Auerbach , executive director of the Public Health Commission.

The regulations will not be enforceable until approved by the health commission's seven-member governing board, which Auerbach said could vote on the regulations within 60 days. He said he expects to propose further changes to the rules based on extensive comments from the biotech industry and the community .

Auerbach calls the debate of the past nine months a ``learning experience" that highlights an irony of public health: To protect the public from disease, researchers must have access to exactly the dangerous viruses that people worry about.

``We do think it is an appropriate role for the commission, to oversee safety in labs working with dangerous organisms," he said. At the same time, he said, ``we feel an obligation to the public to encourage an environment where you can develop an effective vaccine."

Stephen Heuser can be reached at sheuser@globe.com.