As you may know from recent news reports, there have been lapses in safety practices at federal laboratories involving potentially lethal microbes such as avian flu (H5N1) and anthrax, including an incident involving discovery of 60-year old smallpox vials in an FDA laboratory building located on the National Institutes of Health (NIH) campus in Bethesda, MD. Such lapses, which undermine public confidence in biomedical research and could put people’s health at risk, remind us of the need for constant attention to biosafety standards.
Scientists can never become complacent in routine safety practices—one mistake could have serious repercussions. Consequently, we at NIH are taking remedial action and precautionary steps to improve our lab safety protocols and procedures, minimize the risk of recurrence, and increase timely reporting of potential problems.
We also want to remind all of the universities, hospitals, and other research organizations across the nation that receive NIH funding that they also need to have their houses in order.
Today, NIH issued a Guide Notice to reinforce the message that our grantees must meet all applicable federal, state, and local health and safety standards for research conduct. Just as with federal labs, grantee institutions are expected to run rigorous programs of biosafety oversight that include attention to safe lab practices, training, and appropriate policies and procedures. In fact, such steps are actually required in the terms and conditions of all NIH grant awards.
To raise awareness of these critical issues, NIH and other agencies within the Department of Health and Human Services (HHS) are initiating National Biosafety Stewardship Month—a time for federal labs engaged in biomedical research to focus special attention on safe practices. You may have seen information being reported and widely shared that refers to a 24-hour “stand down,” but given the complexity of carrying out the steps outlined below in large and complex biomedical research laboratories, we are proposing to accomplish this over a longer period. Specifically, during the month of September, our labs will do the following:
- Reexamine current policies and procedures for biosafety practices and oversight to see if they need to be modified to optimize their effectiveness;
- Conduct inventories of infectious agents in all labs to ensure that the institution has a record of which infectious agents are being used, along with documentation that those agents are properly stored;
- Reinforce biosafety training of researchers, lab support staff, and members of institutional biosafety committees, to include:
- Reexamining training materials and practices;
- Updating materials as appropriate; and
- Ascertaining the appropriate frequency of training.
We urge all of NIH’s grantee institutions to do the same at the local level. National Biosafety Stewardship Month provides scientists all around the country with an opportunity to reinforce existing practices; revisit existing guidelines and resources (for example, NIH’s guidelines for research involving recombinant or synthetic nucleic acid molecules); optimize further biosafety oversight; and strengthen partnerships to achieve our shared biosafety goals.
Institutional biosafety committees and biological safety officers will play crucial roles in such efforts, and NIH will be sending them a letter to encourage participation. While grantee organizations are not required to submit documented assurance of their compliance with or implementation of these regulations and guidelines, they should be able to provide such documentation upon request.
We hope the entire biomedical research enterprise will join us in promoting conscientious research practices and creating a culture that not only values—but that diligently practices—laboratory safety.
Note: Sally Rockey, Ph.D., is NIH’s Deputy Director for Extramural Research; Lawrence Tabak, D.D.S., Ph.D., is NIH’s Principal Deputy Director; Amy Patterson, M.D., is NIH’s Associate Director for Biosecurity and Biosafety Policy.
Ensuring Biosafety and Biosecurity in U.S. Laboratories, Lisa Monaco and Dr. John Holdren, Office of Science and Technology Policy Blog, 28 August 2014
Media Statement on Newly Discovered Smallpox Specimens, Centers for Disease Control and Prevention (CDC), 8 July 2014
Media Statement, CDC Lab Determines Possible Anthrax Exposures: Staff Provided Antibotics/Monitoring (CDC), 19 June 2014