The White House is asking federally funded labs studying infectious agents to take “immediate action” to inventory samples and review safety and security procedures in the wake of several high-profile accidents earlier this year.
The directive, a memo sent to federal agencies on 19 August but only posted online today, allays fears in the academic community that nongovernment microbiologists might be ordered to stop work for 24 hours and conduct an inventory. Although the memo from the Office of Science and Technology Policy (OSTP) uses the term “stand-down,” it says explicitly that the review should not disrupt ongoing work. And none of the steps are mandatory for extramural labs with federal funding.
The memo is a response to “three recent U.S. biosafety and biosecurity incidents” that have been widely publicized: the mistaken shipment of live anthrax samples by a biodefense lab at the Centers for Disease Control and Prevention (CDC) in Atlanta; the discovery of 60-year-old vials of smallpox on the National Institutes of Health (NIH) campus in suburban Maryland; and the accidental contamination at CDC of benign poultry flu samples with the deadly H5N1 bird flu. CDC has already announced sweeping changes to improve safety, and the OSTP memo aims to “maximize the positive effect of lessons learned” across the U.S. government.
Within 30 days, all federal labs that ship or work with animal or plant infectious agents or toxins are “urged to perform a ‘Safety Stand-Down.’ ” During that time, leaders will review practices and protocols and develop plans for “sustained inventory monitoring.” But “stand-down” apparently does not mean a work stoppage: The review may take several days so that research and clinical work “are not adversely affected.” Labs should also do an “immediate sweep” specifically for select agents—infectious agents and toxins that could potentially be used to cause harm—and make sure samples are registered or destroyed. (A source close to the matter says officials originally discussed a daylong pause to allow lab staff to focus on safety procedures, but decided the activities could be spread over a month so that research would not have to stop.)
Extramural labs that work with infectious agents are merely “encouraged to hold similar events.” In a notice yesterday, NIH suggested that its grantee institutions review their procedures and inventory specimens in September as part of a new “National Biosafety Stewardship Month.”
The American Society for Microbiology (ASM) is “supportive of efforts to ensure” biosafety, the group said in a comment to ScienceInsider. On 25 August, ASM asked its members to check what’s in their freezers. Thomas Inglesby, a biosecurity expert at the UPMC Center for Health Security in Baltimore, Maryland, calls the OSTP memo “a welcome development … the memo should prompt a lot of activity that can improve safety” at both government and extramural labs.
But molecular biologist Richard Ebright of Rutgers University in Piscataway, New Jersey, calls the memo “very thin gruel.” A longtime critic of biodefense labs, Ebright notes that most select agent work takes place at academic or other nonfederal labs. He says that the OSTP memo is unlikely to affect their activities because the actions are recommendations, not requirements.
The memo also outlines longer term plans to tighten oversight of pathogen research. An existing interagency committee will review gaps in biosecurity and biosafety procedures government-wide and “identify an approach to determine the appropriate number of high-containment U.S. laboratories” working with select agents. Another committee will conduct a broad public review of the impact that select agent regulations have had on research and security.
The call for a review of the number of high-containment labs “is a positive sign that OSTP has reversed its previous position and now agrees that a needs-assessment is desirable. But much depends on the details,” Ebright says.
The recent lab mishaps have heightened concerns about the risks of so-called gain-of-function experiments that modify dangerous influenza strains to spread more easily in mammals. The memo does not mention any plans to review these controversial experiments. But the source familiar with the OSTP memo says the federal government is looking at ways to address any questions they raise.