Presidential Order Balances Security and Scientific Enterprise

Today the President signed an Executive Order that, when implemented by the relevant Departments and agencies, will help the United States achieve a crucial balance between two goals that are sometimes seen as being in conflict: Increasing the Nation’s defenses against the threat of biological weapons and reducing the hurdles that legitimate scientists face as they pursue research on potentially dangerous microbes.

This Executive Order is the product of an intensive collaboration that has been going on over the past year under the leadership of OSTP and the National Security Staff. It simplifies and harmonizes a number of earlier efforts to achieve the right balance between the risks and benefits of scientific research on some of the world’s most dangerous infectious agents and toxins. It recognizes that access to these materials and the rules for handling them need to be carefully regulated. But it also recognizes that the best way to prepare for an attack involving one of these agents—whether that attack is by an enemy or by Mother Nature—is to know as much as possible about these microbes and toxins in advance.

Today’s EO, calls for a number of actions, including creation of a new, tiered, risk-based classification of dangerous biological agents that more precisely defines the degree of research restriction appropriate for each, and better coordination among Federal Departments and agencies that oversee this important Federal research portfolio. It builds and improves upon crucial first steps taken by Congress, including the Antiterrorism and Effective Death Penalty Act of 1996, the USA PATRIOT Act of 2001, and the Bioterrorism Response Act of 2002, which created a framework of policies overseeing a class of dangerous biological entities collectively known as Biological Select Agents and Toxins (often simply referred to as “select agents”). This includes infectious agents such as bacteria and viruses—as well as an array of biologically-based poisons—that have the potential to pose a severe threat to public, animal, or plant health, or to animal or plant products including food. The idea behind these laws is to ensure that personnel handling these agents in research labs and other settings have the appropriate training and skills to handle them safely and securely, and that these agents are handled only in facilities designed to prevent their escape and equipped to ensure their proper disposal.

Over the years, however, this accumulation of legislation and regulation grew increasingly complicated and confusing. In addition to technical questions, there were cultural disconnects. After all, most work on select agents and toxins is unclassified and conducted in university settings that have a long history of openness, collaboration, and resource sharing. The situation for these scientists became even more complex as Federal Departments promulgated management guidance and policies regarding the security of select-agent facilities under their direct control or with whom they had contracts or grants. Some Departments initiated their own oversight and inspection processes independent of the overarching Federal program. Although these changes were well intended, a number of studies in the past 18 months, including a recent interagency review led by the Homeland Security Council, concluded that many of these changes in policies and practices had increased the complexity and raised the costs of compliance without demonstrably reducing the overall risk of theft or misuse.

One telling study, published last year, made very clear the toll this complexity is taking on scientists working in this important field. As part of a survey to assess how effectively select-agent regulations are achieving their goal of protecting public health and national security, Victoria Sutton from the Center for Law and Public Policy at Texas Tech University School of Law asked scientists how stressed they were about the possibility they might inadvertently violate one of the many regulations or rules relating to their work, which could harm their careers or trigger negative consequences for the field. Interestingly, while only 16% of the 198 surveyed scientists reported being moderately or highly stressed about the possibility of injury or death from their work with some of the world’s deadliest pathogens, nearly two-thirds of them said they were moderately to highly stressed about the possibility they might unwittingly break a rule!

Today’s Executive Order creates a new and more coordinated strategic framework that outlines specific roles, responsibilities, and actions to be taken by Departments and agencies to optimize national security—recognizing that such security requires an appropriate blend of research restrictions and freedoms. The Order also spells out deadlines by which time Federal entities must implement their new policies and practices. Among the strategic framework’s major components:

• Creation of both an Interagency Coordination Council and a Federal Experts Advisory Panel to, respectively, coordinate security policies and practices among Federal Departments and agencies that fund work on select agents and advise agency Directors on such topics as physical security and ways of ensuring the reliability of key personnel.
• Tiering and stratification of the select agent list to take better account of individual agents’ specific potential to cause mass casualties if deliberately misused, and issuance of new rules and guidances spelling out physical security and personnel reliability practices to be applied at each tier.
• Coordination of Federal oversight and inspections of facilities where work on select agents is underway.

The new Executive Order is a win, both for scientists who have been frustrated as they’ve sought to study these agents for the public good and for the American people who count on the Federal government to protect them from those who would use these agents to cause harm. As one of many people who spent many months working to get this balance right, I am very happy to see this final product come out over the President’s signature.

Peter Emanuel is Assistant Director for Chemical and Biological Countermeasures at the White House Office of Science and Technology Policy