by GMU biodefense graduate student Justin Hurt
On August 21st, 2018, the National Academies presented a “Luncheon Series” discussion on recent research conducted by a Department of Defense sponsored group to assess the state of national biodefense and biosecurity efforts. Titled “A Roadmap for Biosecurity and Biodefense Policy in the United States,” the discussion centered on a research study conducted over the past year that sought to define the linkages and differences between the various biodefense and biosecurity-related policies, regulations, legislation, and agreements, how they affected stakeholders in affiliated institutions and organizations, and where gaps may exist that require further analysis.
Moderated by Katherine Bowman of the National Academies, two of the main contributors to the study, Diane DiEuliis of National Defense University’s Center for the Study of Weapons of Mass Destruction (WMD) and Kavita Berger of Gryphon Scientific, discussed their research process and findings with a large group of academic, non-profit, and governmental associates during the monthly National Academies lunchtime discussion series. The impetus for the study was largely founded in the recent increase in interest regarding biodefense and biotechnology advancements and risks over the past two years. This included heightened international engagements, changes in the biotechnology landscape and the advent of new uses for biological science, all of which have contributed not only to potentially life-enhancing and prosperous outcomes for mankind, but also increased anxieties about the potential for illicit and dangerous uses of such technology.
The researchers used a systems-based approach to looking at biosecurity policy in the United States, and considered factors like changes in the structure of organizations with policy responsibility, such as the Department of Homeland Security’s Science and Technology Directorate, the advent of the Congressional Biodefense Caucus, and the development of the forthcoming national health security policy and biodefense strategy. Using these, a review of pertinent regulation, and other factors, they built a basic understanding of all of the prior and existing biodefense policies, discovering that many were reactionary in nature. From this they developed key questions and a roadmap to address such questions as, “How can we implement a national biodefense policy with the most relevant emerging technologies, while addressing the real and tangible associated risks?”
The research approach was three-pronged: first, the team did a policy analysis, followed by an evaluation metrics analytical framework, and finally an opportunity cost analysis. The policy analysis used policy mapping, an overview of policy implementation and a case study of the recent horsepox virus laboratory synthesis as part of the methodology, determining that policies tended to be clustered in groups either by concentration in biodefense, or prevention of technology and threat development, or biosecurity, primarily those efforts designed to proscribe illicit use, transfer, or acquisition of material. For evaluation metrics analysis, the team conducted a review of scholarly literature, and the policy and program metrics already in use. Finally, for opportunity cost analysis, the research group did three case studies, using the recent addition of SARS coronavirus to the select agents list, removal of restricted pathogens from some institutional programs, and efforts in the regulation of dual-use technologies. The team recognized that Presidential Policy Directives 2 and 10, which both have biodefense/biosecurity implications, were insufficient alone. However, when coupled along with other available information and regulatory policies, could address much of the requirement to address biological threats as they pertain to the emergency management phases of situational awareness, prevention, preparedness, response, and recovery.
Using their collected data and policy analysis, the research team created a large relational database, including relevant legislation and determined how well policy, guidance, international agreements, and regulation applied appropriately to what they were intended to address. The two groupings, biodefense and biosecurity, provided an interesting map of the linkages between the various policies and also demonstrated some unexpected outliers. Then the policy items were grouped according to the stakeholders that were deemed responsible for implementing each of the policy objective activities (such as those in government, the public health community, research, etc.). Some stakeholder linkages were easy to identify, especially those that were explicit in the policy. Others, such as the stakeholder responsible for developing biodefense forensics (implicitly an organization like the FBI), were not readily apparent and more open to interpretation.
The study sought to understand the observed consequences from the historical implementation of policy and the various case studies and identified that there was a threshold at which individual entities or institutions seemed to choose not to conduct activities requiring compliance with certain policies, such as those concerning research with select agents. Although this threshold might be different based on the type and size of a particular organization, there was nonetheless a hesitation from many institutions to undertake certain activities due to perceived cost benefit concerns. As a result, the research group was able to come to some important conclusions. First, there was a recognition that there were some significant tradeoffs as a result of the effect of high direct costs to an entity, such as an impact on funding, the ability to participate in drug or vaccine development, a lack of training and education opportunity, etc. Some institutions found workarounds, like developing partnerships to help with costs, using visiting scholars for research at cleared laboratories, dividing the burden of compliance with policies amongst senior staff, and utilizing contract researchers. Second, the study determined that developing, analyzing, and implementing policy in a systematic way with defined expectations enables a more thorough understanding of costs, tradeoffs, and feasibility of implementation. The researchers also felt that a more comprehensive, inclusive biodefense strategy would benefit the entire biodefense/biosecurity enterprise. They also intoned that a forum to share voluntary actions taken by institutions could promote a deeper understanding of the risks and benefits of conducting research with certain materials. Finally, they also identified a few barriers that prevent policies from being fully, effectively implemented.
Some of the limitations that became apparent included the scope and relevance of various policies, many of which are too “list-based,” or designed simply as an obligatory compliance checklist, rather than being descriptive or encouraging compliance culturally. Many policies could also be described as short-sighted, only applying to government funded projects and missing oversight of non-government funded institutions or programs. The lack of consistency in implementation of biodefense and biosecurity policy across agencies also poses challenges, especially where more than one oversight agency might share jurisdiction (such as OSHA for worker safety and USDA for food safety). Finally, the lack of stakeholder engagement can pose problems, when an entity may not even be aware that a policy applies, is required, or that there are resources available to assist with compliance.
To close, the group discussed the overall policy considerations and gaps that may need to be addressed in moving forward with research, regulation, and legislation. The gap in policy regarding forensics and biological attribution was discussed, as well as the need for better integration of data generation and sharing from biosurveillance and early warning programs. They encourage efforts to enhance identification and analysis of capabilities and risks posed by the advancement and adoption of emerging biotechnologies, the development of assistance programs for stakeholders to implement policy and improve compliance in non-punitive ways, and increase the consistency of funding for non-proliferation activities and the implementation of regulation. Much of this can be encouraged through continued study of the biodefense and biosecurity enterprise and its relevant policies, and by continuing relevant assessments of policy implementation over time. One key take-away as the discussion closed was the concept of treating the biological research enterprise as a critical infrastructure sector, much like it is for the chemical or nuclear industry, which might better place focus on the fiscal and regulatory needs of the industry and its associated risks.