GAO Issues Warning on Biodefense Research

Congressional researchers have issued a warning that the increase in the number of laboratories handling dangerous pathogens for anti-terrorism and defense purposes may be causing more harm than good because of a lack of oversight.

Following the 2001 anthrax mail attacks, Congress allocated funds to increase biodefense research. (See ACT, September 2003. ) A preliminary report by the Government Accountability Office (GAO) released at an Oct. 4 hearing warns that the unintended consequence of this reaction to the threat of bioterrorism is that “these labs can be used by terrorists or people with malicious intent to acquire or develop harmful biological agents, posing a severe national security and public health threat.” The report notes that the intelligence community is particularly concerned.

Pathogens are categorized into four biosafety-level (BSL) classifications based on their lethality and contagiousness, as well as the availability of treatments or vaccines. Most pathogens that are considered bioterrorism threats are ranked BSL-3 or BSL-4 organisms, meaning they can only be worked on safely in a high-containment laboratory with at least the same BSL rating.

The GAO report warns that the U.S. government is unable to keep count of BSL-3 laboratories, making oversight impossible. These laboratories are equipped to handle contagious agents that can be transmitted through the air and cause potentially lethal infections. Even federally funded laboratories are difficult to track. The chief author of the report, Keith Rhodes, estimated before the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations that “the number is surely in the thousands.”

At present, there are 15 BSL-4 laboratories in the United States; most are run by federal agencies. Before the 2001 anthrax attacks, there were five. These labs deal with high-risk, life-threatening diseases for which no vaccine or cure is available. The GAO expressed alarm about this rapid expansion because new and inexperienced labs pose a greater risk.

At the hearing, Democrats, such as Rep. Diana DeGette (Colo.) suggested endowing a “single agency with authority over regulation of all these labs.” By contrast, Republican Michael Burgess (Tex.) registered his opposition to “bringing down the regulatory hammer.”

The subcommittee also plans to hold a hearing on the spread of these labs outside of the United States. Public information indicates that 23 BSL-4 labs exist abroad.

Recent violations and accidents at high-containment labs provided the impetus for the GAO report, which is expected to be released in final form in February 2008. Among these were the exposure of a worker to a pathogen at Texas A&M University that went unreported and a power outage at a new BSL-4 lab in Atlanta, as well as the release of the foot-and-mouth disease virus from a laboratory in the United Kingdom.

One day after the hearing, Lawrence Livermore National Laboratory announced that the University of California, which manages the lab’s facilities, had been fined $450,000 for two consecutive errors in shipping anthrax vials. These errors occurred in 2005, and one case involved the release of bacteria from the vials.

Another concern regarding the ballooning U.S. biodefense program has been that even though the Biological Weapons Convention permits defensive research, it is difficult for outsiders to judge whether a country is in fact adhering to the convention’s restrictions outlawing offensive weapons. Some worry that the United States risks undermining its attempts to limit other countries’ research with materials that could be useful for biological weapons development by coming close to this line.