How Safe Are Our Bio-Labs?

On Thursday Congress held the first of a series of planned hearings on the recent — and some might say reckless — proliferation of high-security bio-laboratories in the U.S. The questions at hand: How many such labs, which handle virulent toxins and germs like anthrax, avian flu and SARS, are currently operating in the U.S.? And has the research they've conducted made us any safer today than we were six years ago, just after 9/11?

The answers range from "No" to "We don't know." "[Given] that there is so much that is unknown at the moment, I would have to say we are at greater risk," Keith Rhodes, chief technologist with the General Accountability Office (GAO), told Congress, "because, as the number [of bio-labs] increases, the risk increases. And it's not just the increase in material, it's the increase in laboratories that have less experience than others."

Hundreds, if not thousands, of new labs are now conducting high-risk biological experiments in the U.S., with at least 15,000 technicians working daily on the world's deadliest pathogens — the vast majority of them for the first time. Though FBI background checks are required for people who handle so-called select agents — a government-drawn list of 73 highly lethal pathogens, such as Ebola, ricin and monkeypox — the vetting focuses on security, not bio-safety competence. Yet most lab accidents are due to simple human error, says Dr. Gigi Gronvall, Senior Associate at the Center for Biosecurity at the University of Pittsburgh. Newbies to the lab are typically indoctrinated to safe lab habits through a mentor-apprentice process, but the recent, rapid expansion of bio-labs has stretched thin the pool of experienced lab workers.

The most dangerous research is done in the country's Level 3 and Level 4 labs. Since the anthrax letter attacks of 2001, which killed five people and infected another 17, the government has spent billions on bioterror and infectious-disease research, and on building the high-risk labs that house those experiments. But nobody knows exactly how many such labs exist today. A 2005 survey by the National Institute of Health, which funds much of the country's bio-defense studies, tallied 277 Level 3 labs in the U.S.; meanwhile, a Homeland Security and Health and Human Services report the same year found more than 600. The GAO's Rhodes told Congress, however, the number is "surely in the thousands." Level 4 labs, which handle the most dangerous pathogens — those for which there are no known therapeutics or vaccines, such as smallpox, Ebola and other hemorrhagic fevers — are fewer in number, partly because they're very expensive. Before 2001 the U.S. had five Level 4 labs; now there are 15 in operation or coming on line soon, including the planned $470 million National Bio and Agro-Defense Facility (NBAF), which will cover as much acreage as five Wal-Mart stores. On the short list of states in contention to host the NBAF is Mississippi, which has zero prior experience with such high-risk research. "While some expansion [of labs] may be justified," says Rhodes, "unwarranted expansion without adequate oversight is proliferation, not expansion."

Worse, there is no centralized regulatory body that oversees bio-labs or their work — 17 federal agencies are involved in biological research in some way, but no single agency is tasked with tracking and managing the risks. "Several agencies have a need to know the number and the location of these labs to support their missions," says Rhodes, but no agency actually has this information. The Centers for Disease Control and Prevention (CDC) has primary responsibility for monitoring the use of select agents — but according to critics, it's working with an outdated list. The last revision to the list occurred in 2005, with the addition of the re-created influenza virus that killed some 40 million people in 1918. Still missing from the register: SARS, Hantavirus and other deadly viruses, which, as a consequence, are subject to virtually no regulation at all.

Lack of oversight means lack of policing, which often leads to underreporting of potentially fatal accidents. Labs are required by law to report mishaps with select agents immediately to the CDC, but that doesn't always happen. Case in point: Last year, a bio-lab worker at Texas A&M University became infected with the deadly brucellosis virus. The university did not report the case and may never have admitted it if an industry gadfly, Edward Hammond of the Sunshine Project, had not persuaded a local district attorney to strong-arm the university into giving up its internal records. The CDC then dispatched investigators who uncovered a host of other violations, including unauthorized experiments, failure to report three other infections of Q fever, failure to have all technicians vetted by the FBI, and missing pathogens and infected animals. "Unfortunately, the CDC's August investigation revealed not only shortcomings on Texas A&M's part, but also shortcomings on the part of CDC's own oversight," said Bart Stupak, chairman of the House Oversight and Investigations Committee. "It turns out that the CDC had inspected the very same Texas A&M lab prior to the disclosure of these incidents and found only minor problems."

Responding to intense criticism, the CDC is looking into forming external peer review panels to re-examine select-agent regulations and lab-safety procedures. The agency may also modify reporting requirements — possibly allowing some measure of anonymity, for example, to minimize disincentives for revealing accidents. "This is a relatively young program [which] is providing much improved oversight, but clearly there is more than we can do," says Richard Besser, director for the CDC's Coordinating Office for Terrorism Preparedness and Emergency Response, who defends the recent lab expansion in the U.S., saying it will lead to better diagnostics and make next-generation vaccines accessible to more Americans.

But many experts disagree, calling into question the focus of biological research in the U.S. — on anthrax and plague instead of, say, drug-resistant tuberculosis or the hepatitis viruses — which may be doing the country a disservice. In a 2005 open letter, organized by Richard H. Ebright, a Rutgers University chemistry professor, 758 American microbiologists complained that NIH priorities favoring research of "high bio-defense significance but low public-heath significance" were misguided and jeopardized public health progress.