Boston Globe: Regulations readied for research labs

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Regulations readied for research labs

Safety plan calls for city permits and inspections

By , Globe Staff | November 15, 2005

Boston public health authorities will propose today 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 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 yesterday 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 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 the Massachusetts Institute of

Technology.

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 this afternoon.

University and hospital representatives contacted last night either had no

comment or said their institutions would defer making statements until the

rules had been formally presented.

Public health officials said last 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 , 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 , president of Safety Net, a group that monitors

developments affecting the lives of Roxbury residents.

But 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.

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 from 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 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.

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.

can be reached at stsmith@....

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