CQ HOMELAND SECURITY
June 19, 2008 – 8:33 p.m.
Kennedy-Burr Bill Targets Potential Threats From Within Bio-Research Labs
By Matt Korade, CQ Staff
As the fear of biological attack spurs an expansion of high-security research labs, a new threat has emerged from a place receiving less attention — the labs themselves.
Sens. Edward M. Kennedy , D-Mass., chairman of the Health, Education, Labor and Pensions Committee, and Richard M. Burr , R.-N.C., who formerly headed the Bioterrorism and Public Health Preparedness Subcommittee, have introduced legislation (
The bill would reauthorize the “Select Agent Program”, which regulates and keeps track of research on dangerous pathogens in labs around the country; it also would improve oversight at the labs, setting incident reporting and safety standards and improving worker training.
In addition, the bill would update the list of regulated pathogens to include new, genetically engineered strains, and evaluate how the regulations affect the sharing of scientific research in the rapidly evolving field of biological science.
The bill is needed, its sponsors say, because a major expansion of high-containment labs is taking place across the United States; yet, according to a Government Accountability Office report in October 2007, no one can say just how many labs there are or where they are located.
The labs, which are classified according to the type of agents studied and the risks they pose to workers, the environment and the community, often contain the most dangerous infectious disease agents, such as Ebola, smallpox and avian influenza.
The labs’ rapid proliferation was a response to the shortage in research capacity highlighted after the anthrax attacks of 2001; the Bush administration and Congress subsequently increased funding for lab construction.
The concerns center on the highest-security labs. “Bio-safety-level-four” labs research lethal agents for which effective treatments aren’t available, such as Ebola, hemorrhagic fever and smallpox, and have stringent containment procedures and guidelines; their number has increased from five before the terrorist attacks of 2001 to 15 today, including at least one that’s in the planning stage, the GAO found.
The number of “bio-safety-level-three” labs, which research diseases that are dangerous but can be treated, is far higher but also harder to track.
According to the GAO, about 1,042 of these labs are registered with the Centers for Disease Control and prevention, and another 314 with the USDA — the two federal agencies responsible for regulating dangerous agents under the Select Agent Program (PL 107-188). About two-thirds of these labs are outside the federal sector.
Both kinds of labs have expanded across several sectors, including federal, state, academic, and private, and have a workforce of about 15,000, the Kennedy-Burr legislation says — a workforce that is expected to expand further as more labs are built.
In the case of “BSL-3” labs, owners often upgrade to that level when upgrading or building new facilities in anticipation of future work, the GAO said. Examples of agents studied at these labs include West Nile virus, tularemia and avian flu.
The federal sector for both kinds of labs consists of more than a dozen regulatory agencies, including those at the Health and Human Service Department, the Department of Defense and the Department of Homeland Security, as well as the departments of Commerce, Energy and the Interior.
Kennedy-Burr Bill Targets Potential Threats From Within Bio-Research Labs
Yet, according a survey of these agencies by the GAO, no single federal agency has responsibility for keeping track of all the labs and, thus, knows the risk they might pose, despite the higher risk posed by the newer labs.
Meanwhile, there are nearly 80 pathogens and toxins on the Select Agent Program registration list, more than a dozen of which occur naturally in the United States, the legislation says — and the number has the potential to keep growing as technology makes it easier to create new strains.
Unreported Incidents
Under the program’s regulations, all research institutions, government agencies, universities, manufacturers and others that possess, use, or transfer dangerous biological agents must register and provide information to the CDC and USDA on their research and safety procedures.
But reports from both the GAO and the Health and Human Services inspector general reveal that exposures and potential releases at these labs sometimes go unreported.
The GAO called attention to three recent examples: the failure to report exposures, including a worker’s contraction of brucellosis, and also missing vials at the Texas A&M University in 2006; a power outage at the CDC’s new level-four lab in Atlanta in 2007, which compromised the facility’s negative-pressure containment system; and an outbreak of foot-and-mouth disease, a highly contagious livestock illness, in farms near a lab at Pirbright in the United Kingdom, also in 2007.
The Health and Human Services inspector general report in January found in an audit of eight labs between 2003 and 2005 that some of the labs kept incomplete inventories of biological agents, allowed unapproved access or handling of those agents, and didn’t have complete safety plans.
But institutions can be reluctant to report such incidents out of the desire to avoid negative publicity and scrutiny from the granting agency, highlighting the need for improved reporting requirements and training of staff.
The Kennedy-Burr legislation offers a voluntary incident reporting system to identify protocols for improved safety and security.
“I think it’s fantastic,” said Gigi Kwik Gronvall, senior associate at the Center for Biosecurity of the University of Pittsburgh Medical Center, which has endorsed the bill.
“Right now the only way you learn if something can be improved is if something goes very wrong or if someone’s very proactive about it,” Gronvall said. “This is a way to call attention to potential problems, so other researchers can learn from them and hopefully make the labs safer and more productive.”
Another worthwhile provision, Gronvall said: the evaluation of how the regulations effect the sharing of scientific research. The bill would require an evaluation by the National Academy of Sciences to determine if the Select Agent Program regulations have hindered international scientific collaboration, The report would be due the executive branch and Congress within eight months of enactment.
To deal with the current and expected influx of additional laboratory workers as the labs expand, the bill also would provide minimum safety and training standards, provisions Burr said were necessary to guarantee the safety of laboratory workers and ensure the most efficient and effective procedures for regulating dangerous biological agents.
Kennedy-Burr Bill Targets Potential Threats From Within Bio-Research Labs
“In this time of exciting scientific advances,” Burr said, “we must make sure our laws and prevention programs reflect our current conditions.”
Matt Korade can be reached at mkorade@com.
POST A COMMENT
Oops! The following errors must be addressed: