The discovery of smallpox in a refrigerator at the US National Institutes of Health (NIH) in Bethesda, Maryland, on 9 July has apparently sparked some soul searching in the US government. On 27 August, the NIH designated September as National Biosafety Stewardship Month, encouraging researchers to take inventory of their freezers for potentially dangerous agents such as pathogens and toxins, and review their biosafety protocols. The White House Office of Science and Technology Policy (OSTP) did the same in a memo released to the public on 28 August, suggesting “a government-wide ‘safety stand-down,’” and “strongly urging” both federal agencies and independent labs to complete these steps within the month.
Although the OSTP does not have the regulatory power to enforce inspections, documents obtained exclusively by Nature show that some government agencies are already starting strict surveillance of their labs. In July, the NIH began scouring its own facilities for any misplaced hazards. Its rigorous strategy, obtained through public-records request, requires laboratories at all of its campuses — whether they work with infectious diseases or not — to survey their vials and boxes for potentially dangerous pathogens, venoms, toxins and other agents. The scientific directors of each NIH institute have until 30 September to submit affidavits confirming that this has been completed by the laboratories in their institutes.
The protocols for this comprehensive sweep describe steps that the laboratory directors must take “including, but not limited to: a) randomly choosing several containers in the inventoried repository and confirming that their contents are as expected; b) if feasible, visually inspecting the contents of a substantial number of containers in the repository to be sure they hold vials of the expected type.” Anything unlabelled must be thrown away, and labs are instructed to pay specific attention not only to pathogens, but also to other hazardous materials such as poisons, venoms and explosive materials.
For extremely large collections with more than 10 million vials, such as the tissue sample repositories managed by the National Cancer Institute (NCI), researchers will not need to evaluate every single sample. Instead, they can apply a statistical algorithm to determine how many are likely to be misidentified. The NCI’s algorithm, for instance, would require examining 10,000 out of 10 million samples and matching them to existing electronic records of the inventory, and then extrapolating the rate of mismatches to the entire sample collection.
Other government agencies that work with infectious diseases are also beginning laboratory sweeps. In testimony to Congress on 16 July, Thomas Frieden, director of the US Centers of Disease Control and Prevention (CDC) promised a sweeping inventory of all CDC labs at the wake of a pair of incidents in which scientists were exposed to anthrax, and accidentally shipped flu virus to another lab.
On 25 August, the US Department of Veterans Affairs (VA) sent out a memo to its staff announcing that it would be complying with a “government-wide safety stand-down” while the agency makes sure that none of its labs have unregistered dangerous biological agents or toxins and reviews its security practices. VA scientists have until 24 September to submit affidavits that they have complied with this order.
Carrie Wolinetz, the associate vice-president for federal relations at the Association of American Universities in Washington DC, says that a number of scientists were initially concerned about that the vaguely worded VA requirement meant that research would be suspended for an unspecified amount of time. She sent out a memo to universities on 26 August, clarifying that the OSTP would not be enforcing any mandates. “It’s saying just take a day to take a look through your freezer,” she says. “It’s a good opportunity to do some reflection on what’s in your lab without it being burdensome or regulatory.”
But the lack of regulatory power is what worries epidemiologist Marc Lipsitch of the Harvard School of Public Health in Boston, Massachusetts. “Overall the White House memo is encouraging as the first, small step in a comprehensive approach to biosafety and biosecurity, but it will have little effect unless many other changes are put in place, which remain unspecified at this time,” he wrote in an e-mail to Nature.
Lipsitch is particularly concerned about regulation of experiments that make pathogens such as influenza virus more dangerous, and incidents such as those at the CDC. “The three incidents with [dangerous pathogens] in federal labs that spurred this action are among hundreds that happen each year in US laboratories,” Lipsitch writes. “Given the magnitude of the response that these three incidents have provoked, it is unsupportable to keep secret the details of [these] incidents in general. The poorly justified ‘security’ reason for keeping such incidents secret cannot outweigh the need to understand and learn from them.”