In the wake of several high-profile laboratory safety incidents involving smallpox, anthrax, and dangerous flu strains, the U.S. government is planning to ask federally funded laboratories to pause all work involving “high-consequence” pathogens for 24 hours in order to inventory stocks, according to groups that represent research universities. (Update, 27 August: This is partly incorrect, a source familiar with the matter informed ScienceInsider after this story had been posted; click here for an update.)
“Essentially, what the government will request is a short term on the order of 24 hours suspension of research involving high-consequence pathogens in order to allow institutional lab personnel to take stock of what pathogens they have stored in freezers, cold rooms, etc.,” reads a memo distributed to universities today and signed by Carol Blum of the Council on Governmental Relations (COGR) in Washington, D.C.
Also, the National Institutes of Health (NIH) announced today that September will be “National Biosafety Stewardship Month.”
The stand-down directive is expected to come soon from the White House’s Office of Science and Technology Policy (OSTP), the memo states, and be delivered to labs through funding agencies. The exact language of the OSTP memo is not yet known. Several agencies, including the Department of Veteran Affairs, appear to have already begun the process.
In what appears to be a related move, NIH issued a notice urging institutions to take heed of the recent biosafety incidents. “Recent reports of lapses in biosafety practices involving Federal laboratories have served to remind us of the importance of constant vigilance over our implementation of biosafety standards,” the notice states. It says that in September, NIH and other federal agencies will observe National Biosafety Stewardship Month. Their labs will inventory their collections of infectious agents and toxins and review biosafety protocols and training procedures. NIH’s grantee institutions “are encouraged” to do the same.
NIH's notice comes in the wake of a Monday statement from the American Society for Microbiology (ASM), which represents many researchers working with dangerous pathogens, which called on its members to conduct a similar inventory.
Ron Atlas, a past president of ASM, said in a statement: "The community wants to act responsibly and looks forward to the public release of the [OSTP] memo to clear up any uncertainties. But even before the official release of the OSTP memo the ASM has recommended that its members take prudent steps to know which cultures they possess and where they are located. It is also incumbent on the community to review their biosafety procedures and to ensure that all laboratories have a culture of biosafety compliance that is critical for protecting laboratory workers and the broader public."
Here is the full text of today’s COGR memo:
There has been a lot of speculation about a government-wide biosafety stand down following the Department of Veterans Affairs sending notices to its own research institutions on the topic. Our colleagues at the Association of American Universities (AAU) discussed the subject with senior Administration officials on Tuesday, August 26, and received permission to provide additional information to clarify the issue under consideration by the Federal government for the research community. Please note: the following Q&A is not an official communications from the government but based on notes from the discussion with AAU staff.
*What is the stand-down*? Essentially, what the government will request is a short term on the order of 24 hours suspension of research involving high-consequence pathogens in order to allow institutional lab personnel to take stock of what pathogens they have stored in freezers, cold rooms, etc. This is prompted by some recent, high profile biohazard stories, such as the discovery of smallpox in cold storage at NIH. This would apply to research conducted by and funded by federal research agencies. With the focus on high-consequence pathogens the impact, nonetheless, should be focused on a known group of labs.
*Where does this directive come from*? The directive would come from the Office of Science and Technology Policy (OSTP), through the research agencies, via a memorandum. OSTP had anticipated issuing the memorandum last week but that action is delayed to allow for additional consultation with the Federal agencies. OSTP anticipates the memo will be released soon, at which point labs and institutions may be contacted by multiple agencies about the stand-down. In light of the likely multiple calls for a stand-down, we encourage institutions to coordinate the activity on campus to avoid miscommunications.
*Does this only apply to Select Agents*? No, because all institutions using Select Agents and Toxins should already be keeping track of those pathogens. Ideally, the federal agencies would ask institutions to take stock of all pathogens stored in laboratories. However, they are giving latitude to the scientific community to identify which pathogens, in particular, labs and institutions should be inventoried.
*How is this enforceable*? *What are the consequences for non-compliance*? In short, its not enforceable and there are no consequences for non-compliance. This request is deliberately more about best practices in lab management than it is about imposing new regulations on the community. As of now, the government cannot force any individual or institution to go through this process. Instead, the government is seeking voluntary compliance in a timely manner consistent with the proper management of pathogens. In that vein, the American Society of Microbiology is calling on its members to go through a similar inventory exercise: https://www.asm.org/index.php/publicpolicy-2/statements-testimony/99-policy/policy/93059-freezer-8-14.
Institutions should consider revisiting policies and procedures for closing out labs when investigators transfer to other institutions, retire or change research focus. Often, pathogens are left behind for the use of post-doctoral fellows and graduates to complete work in progress. With the departure of fellows and students, pathogens languish forgotten or ignored in freezers and cold rooms. The Federal government hopes that a systematic stand-down and thorough inventory will allow institutions to identify orphaned pathogens and conduct orderly disposals of the materials. The discovery of small pox on the NIH campus was just such an event materials used by long-departed investigators and stored for a future use that never evolved.
*Will this result in new policy/regulations*? That is not currently the governments intent. It is good to keep in mind that opportunities for additional biosafety/biosecurity regulations are always a possibility, as we are still expecting the next iteration of the dual use research of concern (DURC) policy which will be an institutional policy as a companion to the US Government policy for agencies already in effect and the Select Agent regulations are periodically updated. For the moment, however, this stand-down remains the sum total of government actions.
When the official memo is released, or if we or AAU receive any additional information, we will keep the membership informed.
With reporting by Jocelyn Kaiser.
*Update, 27 August, 3:18 p.m.: This article was updated to include a comment from Ron Atlas and to clarify the source of today's memo.
*Update, 27 August, 4:58 p.m.: This article has been updated to include information on an NIH announcement.