A mock federal inspection of a select agent lab.

A mock federal inspection of a select agent lab.

CDC

U.S. high-containment biosafety labs to get closer scrutiny

Spurred by several accidents at federal laboratories involving risky pathogens, the White House today announced a sweeping set of steps aimed at shoring up biosafety and biosecurity procedures. The plan includes public disclosure of lab accidents, a new system for reporting mishaps, and a review of the large number of high-containment labs in the country.

The incidents included inadvertent shipments of live anthrax samples at the Centers for Disease Control and Prevention (CDC) in Atlanta and the Department of Defense, and the discovery of old vials of live smallpox on the campus of the National Institutes of Health. Accidents at universities have also drawn scrutiny of federal oversight of labs that work with select agents, a list of risky viruses, bacteria, and toxins that could potentially be used to cause harm.

A review launched in August 2014 has resulted in a 3-page memo (plus 184 pages of attachments and related reports) sent today to federal agencies from the president’s science adviser, John Holdren, and Lisa Monaco, assistant to the president for homeland security and counterterrorism. It describes about 50 steps with timelines, ranging from beefed-up biosafety training to plans for an outside review of local labs’ protocols for inactivating select agents. Most steps are to be completed within the next year or two.

A critic of the select agent program, molecular biologist Richard Ebright of Rutgers University in Piscataway, New Jersey, says that several “substantive” and many other “minor” changes in the memo “will improve U.S. select-agent oversight.”

One change that some experts have long advocated is a system for lab workers to anonymously report incidents without fear of reprisals. Federal labs will be required to disclose to the public what agents they are studying and information on accidents, and nonfederal labs will be encouraged to do the same. The federal select agent program must also issue an annual report summarizing all accidents. (The program now publishes such summaries only every few years.)

The memo also calls for a federal assessment of “the appropriate number of high containment U.S. laboratories required” to handle select agents. Ebright and others say the rapid growth in the number of federally funded biodefense labs following the 2001 anthrax attacks has only increased the risks of an accidental or deliberate release of an agent. A review is “crucial” and “a decade-and-a-half overdue,” Ebright says. But unlike most other steps in the memo, this one does not come with a deadline for implementation.

Ebright is also disappointed that oversight of select agents will remain with the CDC and U.S. Department of Agriculture rather than an independent federal agency that does not perform select agent work.

One biosafety expert had only praise for the White House plan. “The memo really speaks to the efforts the U.S. government has taken to address the serious biosafety lapses that occurred at our nation’s laboratories,” says Amesh Adalja of the University of Pittsburgh Medical Center for Health Security in Baltimore, Maryland. “Research on select agents is a very vital national security need and public confidence in the safety of the research is needed for it to successfully continue.” The timelines in the memo, he adds, “mean that progress can be tracked and measured.”