State health officials are weighing new safeguards for research laboratories and biotechnology companies that handle potentially deadly infectious pathogens, but whether they will impose any remains uncertain because they don't know how big a threat there is.
A state panel's report exploring what are known as biocontainment labs found that there is no single federal or state government body that inspects or tracks the facilities to ensure they properly protect the public from the dangerous substances, though many labs are regulated by the Centers for Disease Control or agencies that provide research grants. The state Biocontainment Laboratories Oversight Workgroup report was released this month.
It's not clear how large that regulatory gap might be. Scientists and health officials don't know how many facilities work with agents that could cause serious or lethal diseases, or where they are located, despite efforts to survey labs across the state. That could lead state health officials to consider requiring the labs to register their work as they assess any public health risk.
The investigation seeks to address concerns that the pathogens could spread to the public, either through an accidental infection of lab workers or an intentional release by a lab insider. Such incidents have occurred a handful of times in recent history, according to the report, most notably with the 2001 anthrax attacks on two U.S. Senate offices that were traced to labs at Fort Detrick in Frederick County.
Representatives for higher education research and biotech startups say the risk may not be worth the regulatory burden it would place on them. But, they acknowledge, that depends how large the risk is determined to be, and community advocates say more should be done to evaluate it.
"Communities have a right to know when potentially dangerous activities are going on," said Beth Willis, a member of the state work group and chairwoman of Frederick's Containment Lab Community Advisory Committee, which oversees such safety issues around Fort Detrick. "They have a right to know how safely such labs are being operated."
The concern is over labs that conduct research using bacteria, parasites and viruses that cause illnesses including West Nile virus, SARS, rabies and yellow fever, deemed "biosafety level three" by the CDC, and pathogens like smallpox and the Ebola virus, considered "biosafety level four," the highest hazard level.
Safeguards for biosafety level three research includes proper ventilation of labs, restricted access while work is in progress, and filtration and/or outdoor release of exhaust from the labs.
The most dangerous of those pathogens fall on a list of federally regulated "select agents," including Ebola, SARS, ricin, eastern equine encephalitis and anthrax, and trigger CDC oversight. Research using other, less dangerous pathogens is often subject to oversight by the National Institutes of Health or other research funding agencies.
But the work group, called together by a state law passed last year, questioned whether there might be other labs out there working with dangerous substances that regulators don't know about. The group surveyed about 1,000 labs across the state but only heard back from about 150 of them, though 90 percent of those said they had no plans to do work that would be classified as biosafety level three in the next two years.
The report laid out several options for the state, including requiring permits or registration for research of biosafety level three or greater, but makes no official recommendations. The state Department of Health and Mental Hygiene has not taken a position on the options, but could make a policy recommendation after receiving input on the report from the public, said Jennifer Newman Barnhart, deputy director of administrative support services for the department's laboratories administration division.
Some say more action isn't necessary, given the regulations already in place for the most dangerous agents and for most academic research.
"If we continue to overburden these researchers, research can't be done," said Melissa Morland, biosafety officer for the University of Maryland, Baltimore and a member of the state workgroup.
Because of existing regulations, including two levels of background checks, it takes three to six months to get lab workers approved to work with hazardous pathogens. Adding more regulatory hurdles could add a paperwork burden that her staff can't afford to absorb, Morland said.
As for biotechnology companies, most are doing work through federal small business grants or other government resources, said Judy Britz, executive director of the Maryland Biotechnology Center and another workgroup member.
Any added layers of regulation would need to be "meaningful" to be effective, but might not be worthwhile if only applied to a small number of labs lacking oversight, she said.
"Does it really improve the safety of the community in some way?" Britz said. "It's hard to quantify that and it would come at significant cost."
But Willis, the Frederick group leader, said the risk still could be worth at least gathering more information.
"You don't want regulation for the sake of regulation unless it actually serves the public good," she said. "So somewhere in the public good somebody decided we should regulate tattoo parlors and we do, but we do not regulate these labs."
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