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Proposal Would Raise Regulation of Biolabs

By Stephen Smith

Boston public health authorities will propose sweeping new safety regulations governing more than 1,000 research laboratories working with dangerous germs in universities, hospitals, and biotechnology companies across the city.

The proposed rules would for the first time require labs studying biological agents to receive safety permits from the city and would also break ground by mandating that neighborhood representatives sit on internal safety boards. Regular inspections of labs by internal reviewers and by a city inspector would also be ordered.

Facilities working with especially potent viruses and bacteria, including those that have been identified as potential tools for bioterrorists, would have to provide a list of those materials to city health authorities, as well as an explanation of the research. Until now, only the federal government had access to such sensitive information.

The proposal represents a significant expansion of lab regulation. Until now, city and state governments have usually become involved in research practices only if something went seriously wrong. Researchers must provide documentation of safety practices when they seek federal grants, but no special federal operating permits are necessary.

Boston health authorities said that after examining lab regulations in other cities, they concluded that their proposal would constitute the most stringent municipal regulation of biological research in the nation.

“This does seem to be an important time to guarantee that laboratories that are increasing in the city and around the country are operating at the optimal safety level,” said John Auerbach, executive director of the Boston Public Health Commission.

The proposed rules emerge 10 months after public disclosure that three Boston University scientists had fallen ill while working with tularemia, a lethal bacterium. City health authorities acknowledged Monday that the proposal is a direct response to the tularemia exposures, as well as long-festering concerns from neighbors about the development of a high-security lab at BU where scientists would be capable of working with some of the world’s deadliest germs.

“This will give us some standards to make sure these labs are being monitored,” Boston Mayor Thomas M. Menino said. “These regulations go a long way to show the city is serious about having biolabs in the city and about the safety of them.”

The proposal represents six months of work by an eight-member laboratory safety panel that was convened by public health authorities earlier this year after the tularemia exposures became public. The panel included laboratory safety specialists from Harvard University and MIT.

The regulations must be approved by the Boston Public Health Commission before they can take effect. The commission, along with research institutions, will get a first look at the proposal Tuesday afternoon.

University and hospital representatives contacted Monday night either had no comment or said their institutions would defer making statements until the rules had been formally presented.

Public health officials said Monday night it was unclear how much compliance with the proposed regulations would cost research institutions. The overwhelming majority of labs covered by the proposal are at the city’s research universities and hospitals.

Klare Allen, the leader of an organization that opposes BU’s planned high-security lab, characterized the proposed rules as “a great first step. It’s something that should have been in place a long time ago.”

“If they were being inspected all along, then the scientists wouldn’t be hurting themselves,” said Allen, president of Safety Net, a group that monitors developments affecting the lives of Roxbury residents.

But Allen said she doubted the regulations would allay concerns about the Biosafety Level 4 lab that BU wants to build on its South End medical campus. Scientists in that lab will research vaccines and treatments against deadly illnesses such as ebola, plague, and, potentially, avian influenza.

The city had previously regulated a select group of labs doing specialized research involving DNA transfers from one organism to another. The proposed rules greatly extend that oversight, Auerbach said.

Auerbach said fears that bird flu could ignite a global pandemic in humans had demonstrated the importance of studying such pathogens — as well as the dangers.

“We’ve come to understand as the Public Health Commission the importance of the work in high level laboratories,” Auerbach said.

The proposal focuses in detail on the operation of internal panels at research facilities known as institutional biosafety committees. Those boards are charged with making sure that scientists abide by safety procedures designed to protect them and the public.

But the rigor of those committees varies institution to institution. The proposal being presented to the Public Health Commission would attempt to establish greater uniformity.

“The proposed regulations strengthen and broaden the responsibilities of the laboratory institutional biosafety committees,” Auerbach said.

The safety panels, for example, would be required to report to high-level officials within universities and hospitals, a measure designed to give them real power. The boards would also be ordered to have annual meetings for the public, where research would be discussed, and they would be required to include at least one member of the public as a permanent member. The Public Health Commission would have to approve the public member nominated by the institution.

“There was a concern about the importance of having greater transparency,” Auerbach said. “And we really want to guarantee that there’s an independent, public voice and that the voice is from the areas surrounding the laboratories.”

Institutions would not receive a permit from the city to operate labs unless they were abiding by the rules on internal safety boards. Those permits, Auerbach said, would be good for three years.

As a further guarantee of increased oversight, the institutional biosafety committees would have to conduct inspections at least once a year at lower-security labs and at least twice a year at higher-level labs. Such internal reviews are already mandatory at many research institutions.

The city is also close to hiring its first laboratory safety officer, who would make periodic visits to research facilities to ensure that sure they’re operating safely. Violations of the new regulations could result in fines as high as $1,000 a day per violation.

When the tularemia exposures were made public in January, health authorities conceded that they did not have a process in place for monitoring labs working with the most dangerous germs. The proposed regulations aim to change that by requiring scientists to report the details of that kind of research.

Auerbach said the city will adopt measures to assure that information about sensitive research is “protected under the highest level of security.”

The proposed rules also include a shield of protection for whistleblowers who would want to provide information about troubling practices in labs.