Bioagent control faulted

Federal auditors spotted "significant management weaknesses" in the Centers for Disease Control and Prevention (CDC) system for regulating potential bioweapons, according to a letter sent just weeks before a new, expanded list of these dangerous agents is due to be released. The US General Accounting Office (GAO) found holes in CDC's methodology for registering laboratories that ship dangerous organisms and toxins, gaps significant enough to let the substances slip into the hands of terrorists.The Atlanta-based public health agency agrees with the GAO findings, which were reported in a November 22 letter to US Department of Health and Human Services (HHS) secretary Tommy Thompson. "We've taken some action on some of those criticisms," CDC spokesman David Daigle told The Scientist. The agency has temporarily moved the laboratory oversight function with its staff authorization of 19 people to its National Center for Infectious Diseases (NCID) division, an effort to increase the separation between the regulators and those they regulate.Contracts went out last summer to outside firms that would help the CDC watch over laboratories that have registered their possession of listed, and presumably dangerous, "select agents," Daigle said. The agency will get help with inspections and with maintaining its database, two of the areas GAO identified as problematic.But at least one major university has already had a run-in with a CDC inspection contractor, an encounter that failed to inspire confidence in the future of select agent enforcement.A Stanford University engineering researcher needed brief access to a toxin on the list, and registered the possession independently with the CDC. Unaccustomed to the process by which Stanford submits a blanket registration covering all its labs, the researcher's lab wound up on a list to be inspected by a contractor. Untangling a simple clerical matter was not easy, Lawrence Gibbs, Stanford associate vice provost for environmental health and safety told The Scientist."It took us eight months to attempt to rectify the situation," Gibbs said. "The contractor said they couldn't make the change and they were coming anyway, even though we informed them over and over there was nothing to inspect. A small vial of a toxin had been appropriately disposed of. They were still going to bring a couple of people out and expend all that resource."Stanford finally got through to the right people at CDC, he added. But the experience left officials at the university uneasy about the prospect of ever-more intense scrutiny in the future."One of the concerns we have with the use of untrained and unknowledgeable personnel is that they are going to follow a rote procedure and refuse to deviate from it, even when common sense or science calls for it," Gibbs said. CDC has been in charge of watching over shipments of listed dangerous "select agents" since 1997, under a system established to enforce a 1996 antiterrorism law. After a wave of anthrax attacks killed 5 people last fall, Congress passed new laws that expanded controls and threatened jail time for violators.About 250 laboratories across the country came under the jurisdiction of the 1996 law, which only regulates shipments. Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which applies to both possession and shipment of "select agents," thousands more labs may be subject to the stronger rules governing dangerous toxins and those who handle them. Lab safety managers are awaiting a revised list of these select agents, due out December 9. Depending on which organisms and toxins make the new list — and how they are listed — the universe of labs that CDC is expected to keep safe could expand significantly.CDC's role as enforcer is a job that is out of step with its usual role as a cheerleader for public health initiatives, Gibbs noted. "This is a change for the CDC from what used to be a collaborative agency focused on public health protection to one that is moving into an enforcement mode that is a change not only for the agency but for those who work with it."

Bioagent control faulted

Report finds weaknesses in CDC supervision of select agents in US labs.

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