The US Department of Homeland Security should not be put in charge of biodefence research.
The past few months have brought a rich harvest of high-level reports on US biosecurity, with a particular focus on the nearly 1,400 American labs known to be doing research on human, plant and animal pathogens risky enough to require special containment. The reports were largely inspired by the announcement from the US Federal Bureau of Investigation in August 2008 that Bruce Ivins, a senior researcher at the US Army Medical Research Institute of Infectious Diseases in Fort Detrick, Maryland, was considered to be the “sole culprit” in the deadly 2001 anthrax attacks. Several of the reports — two of them issued last week — recommend that a single agency be put in overall charge of what is now a fragmented oversight system involving at least a dozen agencies. Their laudable goal is to tighten the safeguards against biological threats, including any that might emanate from within the labs, without stifling research on countermeasures against any future attacks.
As always, however, the devil lies in the details. Witness the Weapons of Mass Destruction Prevention and Preparedness Act of 2009 (see page 577), a bill introduced in the Senate last month by the two top lawmakers on the Senate's Committee on Homeland Security, Joseph Lieberman (Independent, Connecticut) and Susan Collins (Republican, Maine). Perhaps not surprisingly given their committee's purview, Lieberman and Collins's bill would vest authority for regulation of the biodefence research complex in the Department of Homeland Security (DHS). But the DHS, a hotchpotch assembled from 22 existing agencies in 2003, combines a sprawling mandate with a paucity of biological expertise. It stands in stark contrast to the US Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, which has overseen labs working with a predetermined list of deadly human pathogens since 1997. (Animal and plant pathogens are handled by the US Department of Agriculture.) The Lieberman–Collins bill has accordingly alarmed scientists in this field, who say that their experience to date in executing contracts for the DHS has revealed a disturbing lack of expertise in its inspectors.
Opponents of the bill are also concerned by its designation of a new category of 'Tier I' agents for extra-tight regulation, including new levels of scrutiny to establish “personnel reliability”. Lieberman said last week that only about eight microbes would fit this category. But the bill allows the secretary of homeland security to move any human pathogen into Tier I at any time, without having to provide a reason in public. This contrasts with the checks and balances — including consultation with scientists and public comment and discussion — now required to add a microorganism to the list of those overseen by the CDC or the agriculture department.
The fear is that the new Tier I requirements, and the costs they imply, would discourage labs from working on such pathogens. There is also the possibility that individual scientists will decide to choose microorganisms — or fields — more congenial to personal privacy. Already, researchers who work with any of the current 82 agents on the CDC's list must submit to a Department of Justice background check that involves fingerprinting and access to personal financial and medical records. At a recent American Society of Virology meeting in Vancouver, Canada, informal talk was about research being driven into Canada or the European Union, and the risk to careers associated with listed-agent work if labs begin to walk away from its costs.
Lieberman and Collins undoubtedly have good intentions with this bill. But they would be well advised to consult more carefully with front-line researchers before finalizing legislation in which so much is at stake. They should particularly consider the long experience and expertise resident in the CDC before making such a dramatic shift of lab oversight to an untried department.