Eager to avoid the controversy associated with the development of a biodefense lab in neighboring Boston, as well as to plug what it considers a loophole in current law, the Cambridge, Mass., Public Health Department is working to legally bar the creation of new Biosafety Level 4 laboratories that carry out research on the deadliest pathogens.
The department would also require labs that deal with less-deadly pathogens — BSL-3 and even some BSL-2 labs — to apply to the city for annual permits.
The proposal defines such agents as "any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae or protozoa) or infectious substance, or any naturally occurring, bioengineered or synthesized component of any such microorganism or infectious substance" that meets two criteria:
• They must be classified as a Risk Group 3 through 4 Agent by the National Institutes of Health Guidelines; and
• They must require containment in either a BSL-3 or BSL-4 lab, as determined by an "institutional biosafety" committee, the final arbiter of the regulation and accompanying implementation guidelines.
Such permits are already required by Cambridge of BSL-4 labs that handle recombinant DNA, under the 1977 Cambridge Recombinant DNA Technology Ordinance. Since 1977, work with recombinant DNA has come to encompass most of the activity carried out by life-sciences companies and research institutes. As a result, those establishments have had three decades since the original law to develop much safer sets of manufacturing, processing, and research protocols, according to Sam Lipson, director of environmental health for the Cambridge public health department.
Describing what he considers a loophole in that ordinance — the first of its kind nationwide — Lipson said "the oversight of not choosing to have authority over high risk, non-recombinant work was just that: an oversight. Back in the '70s, people were more concerned about the novel nature, the exotic, unusual, and unpredictable nature of recombinant technology. They were less focused on the existing risk that biological work might pose."
Lipson said his department now aims "to see that what was seen as a legal loophole was not going to be utilized in the future. Because it regulates only recombinant work — and this was true in Boston as well — there was the possibility of an institution or company proposing a BSL-4 lab that was not going to involve recombinant work. This closes off that option."
There has been no request to build a BSL-4 lab in Cambridge since the ordinance was enacted, he added.
Lipson spoke on Wednesday, several weeks after the public health department held a hearing on a new set of regulations governing biolabs that handle biological agents.
The proposed Cambridge Biosafety Regulation would bar the development of new BSL-4 labs in Cambridge by stressing the city's current absence of such facilities, and would establish new rules governing how biological agents should be handled by BSL-3 and some BSL-2 labs.
The city is seeking comment on the proposal, which can be sent to Lipson here or via mail at Cambridge Public Health Department, Ground Level, Cambridge, MA 02139. The comment deadline is July 31, 5 p.m. EST.
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After that date, the Cambridge Public Health Commission will vote on whether to make the regs official. By then, the regs will have an effective date, which Lipson said will be "some time in late August or early September."
Of the 70 labs that operate under permits obtained from the city, five are BSL-3 labs — of which two are operating under that standard, and the rest are either not in use or are essentially enhanced BSL-2 labs, since labs with a given classification can operate at a lower standard that allows for research on less-dangerous pathogens.
The third, to be operated by Novartis, is about to come online as a fully commissioned BSL laboratory, Lipson said.
Cambridge requires permits for each facility that has labs, but does not insist on separate permits for each lab.
Those five labs, and any others that want to handle biological agents, would have to apply for permits to be issued by the city's commissioner of health and hospitals, following approval by the CBC. The regulation would not affect most BSL-2 labs or any labs rated BSL-1; both types combined account for most of the 65 labs regulated by Cambridge's public health department.
The new lab law would retain the city's current fee schedule, which requires:
• Facilities with fewer than 10,000 square feet of biological lab space, plus waste storage, to pay $250 per year;
• Labs with between 10,000 and 40,000 square feet of biological lab space, plus waste storage to pay $500 annually; and
• Labs with more than 40,000 square feet to pay $1,000 per square foot.
Lipson said the city currently inspects new labs, especially BSL-3 labs, at different intervals of their constructions: when operators design at least 25 percent of their space, as they are about to start construction, and as they prepare to commission their new labs or soon afterward.
Operators must also present to the IBC documents detailing their plans, including a summary and protocols of work taking place in their labs.
"Sometimes it's more useful to go in after they've fully set it up and just as they begin work. Then they can't hide behind the notion, 'Oh well, we weren't quite ready, and we didn't put this or that up, but we intended to before we started," Lipson said.
BSL-1 and -2 labs see less scrutiny, with Lipson saying they "don't need to be reviewed by us before they're built out. Many of them already exist. Many companies are moving from one lab space to another." However, operators of those labs do need to come to Lipson before they begin regulated work in the labs, he added.
The city is finishing an updated version of its policies and procedures governing details for carrying out its lab regulations. Lab operators must file reports with the city annually, and must undergo site visits from the city in advance of changes to their labs. However, BSL-1 and -2 labs could in many cases skip the requirement of making a presentation to the IBC if their changes are deemed minor — meaning no new protocols are being adopted — and if they come within three years of the initial permit.
The proposed law balances its stricter oversight by not extending to BSL-1 and traditional BSL-2 labs, Lipson added.
While Lipson is the sole enforcer of the proposed new law, he said his department is kept up to date on changes to existing labs through regular communication with the city fire department.
One resident who has sparred with city officials over their reviews of several lab projects has contended that the current proposed policy leaves too much potential for harm to public health if a pathogen escapes from a lab.
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"It's ridiculous to think Sam Lipson can regulate and monitor the sheer number of labs down here," Marie Ellen Saccoccio, a fourth-generation resident of the city's East Cambridge neighborhood with a law practice based in the city, told BRN Tuesday. "I think having a one-man show is a mistake. There's no way in the world any person — even if we got a Nobel Laureate — they couldn't do this job."
Lipson told BRN the criticism is baseless, and that the city's oversight of labs is strong enough to prevent harm to city residents.
Saccoccio was among city residents that tried, but failed, to stop the Cambridge City Council earlier this year from approving zoning changes sought by life-sci space developer Alexandria Real Estate Equities in connection with a $1 billion, 1.8 million-square-foot laboratory-residential campus it wants to build on 15.7 acres within East Cambridge [BRN, Feb. 17]. Opponents of that project, and a since-withdrawn proposal by local developer Beal Cos. [BRN, April 17], said the projects were too dense for the surrounding neighborhood, and would create a net reduction in residents' quality of life.
The lab projects drew the attention of numerous residents and the City Council, which in turn "compelled them to pay more attention to the overall management of laboratory-management regulations in Cambridge," Lipson said. "It created an atmosphere of interest and concern."
Cambridge officials have found support for the change in regs from the Massachusetts Biotechnology Council, a trade group representing more than 600 life-sci companies, academic institutions, and others across the Bay State.
"Cambridge is strong in biotechnology because there are strong regulations in place," Stephen Mulloney, the biotech council's director of policy and public affairs, told the Cambridge City Council in testimony during a special meeting Dec. 1. "If our safety measures were so inadequate or cavalier that the persons at greatest direct risk — the scientists at the bench — were in a position to be harmed in any way, then the biotechnology industry as we know it would cease to exist. There would be no companies, no researchers, no quest for cures, no benefits for the city."
Mulloney told BRN this week that his group will work to ensure that the new measure will not spark a dramatic jump in permit fees.
"We're pretty pleased with the draft regulations. We think they're reasonable. It's something our companies believe we can live with and can work with," Mulloney said in an interview. "A lot of people see the proposed regulations as just a natural and logical extension of the existing framework."
Because the city's lab regs are the oldest in the nation, Mulloney added, "companies are used to being overseen by the city. Their view is that this is not any great change from what they've been used to."
The public health department began its review after members of the city's Cambridge Biosafety Committee expressed concerns that current law might touch off a replay in the city of the citizen opposition and legal wrangling that has surrounded Boston University's construction of its $198 million, 192,000-square-foot National Emerging Infectious Diseases Laboratory, or NEIDL, near the Boston University Medical Campus in Boston’s South End.
"The fact that the NEIDL was built with great controversy, it was perceived to have had a very poor public process, and raised the profile of this issue in both cities. I would say it created the political will to go ahead and make the changes that had been something we had considered for some time, but just didn’t have a compelling momentum to do," Lipson said.
While NEIDL has been completed, it is used solely for training programs due to a long-running legal dispute between BU and residents living near the biolab, who have sued BU seeking additional environmental review of the project. The opening of NEIDL has been delayed until at least the fall of 2010, and possibly later, as the National Institutes of Health performs supplemental risk analyses into the lab's ability to operate safely in general, and specifically in its ability to contain 13 toxins to be studied there [BRN, April 17].
"The court is awaiting the completion of the additional risk-assessment studies that are expected to be available from NIH for public comment at year’s end," BU spokeswoman Ellen Berlin told BRN on Wednesday.
On June 24, BU announced that a set of simulated safety and training exercises set to last six to eight months will begin later this summer or in the early fall. The university stressed that no research was being conducted, and no research agents were being used at any time during the exercises.
“While the legal and regulatory issues on the use of the facility for biosafety research continue, we will use this time to train and familiarize research and safety personnel with the NEIDL," Mark Klempner, NEIDL's principal investigator, said in BU's announcement. "We will reenact a research project and all its processes and ensure that our standard operating procedures are appropriate and that our researchers and our community will be appropriately protected.”