Enhancing Biosafety and Biosecurity in the United States

On August 18, 2014, we issued a memorandum titled “Enhancing Biosafety and Biosecurity in the United States,” urging all U.S. government departments and agencies that work with infectious agents to take immediate and long-term steps to enhance safety and security in research facilities to minimize the potential for biosafety and biosecurity incidents.

All federal departments and agencies that possess, use, or transfer human, animal, or plant infectious agents or toxins were urged to perform a Safety Stand-Down, to include an immediate sweep of their facilities to identify Biological Select Agents and Toxins (BSAT) and ensure proper registration, safe stewardship, and secure storage or disposal. During the Safety Stand-Down period, senior leaders were also urged to devote significant, dedicated time to review laboratory biosafety and biosecurity best practices and protocols, as well as to develop and implement plans for sustained inventory monitoring.

Federal departments and agencies embraced this effort. As part of their Safety Stand-Down activities, they conducted facility sweeps; carried out comprehensive safety, security, and inventory activities; and captured best practices and plans for strengthening national biosafety and biosecurity systems in the future. 

During the Safety Stand-Down period, 11 U.S. government departments and agencies conducted sweeps at more than 4,000 facilities across the nation and in U.S. facilities abroad, including more than 40 million samples. As a result of this comprehensive review, departments and agencies reported 27 instances in which identified BSAT were stored in areas not registered with the Federal Select Agent Program, adjudication for each instance, and final disposition for the material. In reviewing the findings, there was no indication of human exposure, including staff or the general public, to any of these agents or toxins. 

In our August 18 memorandum, we also urged non-governmental facilities that possess, use, or transfer human, animal, or plant infectious agents or toxins and receive funding from the federal government to voluntarily take part in the Safety Stand-Down. Federal government staff, as well as the professional societies representing the life-sciences community, engaged in extensive outreach to extramural laboratories. A number of entities responded and conducted independent inventory reviews during the Safety Stand-Down period. In all cases, the Federal Select Agent Program worked with these organizations to ensure that all identified BSAT was either destroyed on-site or transferred to an organization registered to possess BSAT. 

As a result of the Safety Stand-Down, departments and agencies are taking steps to improve inventory management practices and identifying excess biological agents and equipment for disposal. U.S. government facilities that have responsibilities for supporting scientific advances to combat infectious disease threats are employing biosafety and biosecurity best practices to ensure the health and safety of workers and the American public. Facilities are also identifying additional steps that can be taken to advance best practices in biosafety and biosecurity for storing, handling, and working with infectious agents, toxins, and other biological derived materials. Moving forward, the Administration stands ready to share the Safety Stand-Down as a best practice with non-federal partners and the international community. 

The Administration is committed to advancing national biosafety and biosecurity systems here at home and around the world as an integral component of the Global Health Security Agenda (GHSA). The Ebola epidemic has highlighted the importance of this effort. The Administration intends to achieve – domestically and with partners around the world – the measurable target established under the GHSA to advance national biosafety and biosecurity systems. 

Lisa Monaco is Assistant to the President for Homeland Security and Counterterrorism and Deputy National Security Advisor. Dr. John Holdren is Assistant to the President for Science and Technology and Director of the White House Office of Science and Technology Policy.