The White House’s homeland security advisor, Thomas Bossert, recently told a group at the annual Aspen Security Forum, “We have not had as a country a comprehensive bio-defense strategy ever. It’s high time we had a bio-defense strategy.” This probably came as a surprise for most professional analysts who work on weapons of mass destruction (WMD) issues, since there have been three relatively recent biodefense strategies within the last fifteen years. The first was the Homeland Security Presidential Directive 10 (HSDP-10), “Biodefense for the 21st Century,” released by the Bush administration in 2005. This was, to say the least, a significant attempt to build a comprehensive biodefense strategy using assets from the new Department of Homeland Security, the Department of Health and Human Services, and the Department of Defense. This directive featured four pillars of a national biodefense program, each of which translated into several active programs within the three departments.
The second one was the National Strategy for Countering Biological Threats, also known as Presidential Policy Directive 2, released by the Obama administration in 2009. One might argue about how comprehensive this strategy was, but it attempted to direct government agencies involved in responding to either natural infectious diseases caused by Mother Nature or deliberate biological releases by bad actors along a common national-level approach. It addressed the concern by policymakers that a biological attack might not be distinguishable from a natural disease outbreak, limiting a quick government response.
There was also a National Strategy for Biosurveillance in 2012, which, while comprehensive, did not significantly change the way that the US government addressed biological threats. Mostly, the biosurveillance strategy caused a flurry of action by executive agencies to justify what their programs were currently doing. This is not to say that there wasn’t enough biosurveillance going on, just that nothing really significantly changed after the strategy was released.
Interestingly enough, this latest call for a national biodefense strategy came from Congress, articulated through the National Defense Authorization Act for Fiscal Year 2017. Under Title X (General Provisions), Subtitle G (Other Matters), Section 1086, Congress has tasked the secretaries of defense, health and human services, homeland security, and agriculture with “jointly develop[ing] a national biodefense strategy and associated implementation plan.” This strategy is to include a review and assessment of ongoing biodefense policies and programs. Why, then, has there been this directive to develop a new, comprehensive biodefense strategy?
It can be partly explained by current events involving the threat of biological organisms to the general public. Between 2004 and 2017, there have been numerous public health groups and officials clamoring about the need to invest more federal funding into medical countermeasures and networks to protect against pandemic outbreaks. These were largely fueled by the natural outbreaks of avian flu, swine flu, and influenza. It could be, with the turnover in the White House, Congress felt that now is the appropriate time to revisit the adequacy of biodefense measures. Recent events—an Ebola outbreak in West Africa (2014–2016), a Zika outbreak in South America (2015–2016), and revelations of the US Army’s mishandling of anthrax samples at Dugway Proving Ground (2015)—may have helped push this idea along.
There has also been the aggressive lobbying effort by two particular groups whose members include former political office-holders and pharmaceutical companies. In 2010, the chairs of the Congressional Commission on the Prevention of Weapons of Mass Destruction formed a nonprofit called the “WMD Terrorism Research Center.” Former Senators Bob Graham and Jim Talent gave the federal government an “F” for what they argued was a lack of efforts to improve the country’s response capabilities for bioterrorism incidents. This was not to say that the nation was unprepared to respond to a biological incident, but they felt that much more was needed and they didn’t see the necessary steps to improve capabilities. In 2009, prior to forming their research center, the two former senators had called for a new, focused US biodefense strategy, but that call fell on deaf ears.
The other group is the “Blue Ribbon Study Panel on Biodefense,” chaired by former Senator Joe Lieberman and former DHS Secretary Tom Ridge. Between 2014 and 2015, they hosted four public meetings (one for each pillar of the HSDP-10 biodefense strategy) to review the US biodefense efforts. After releasing a report identifying several steps required to address perceived weaknesses, the two chairs talked to congressional committees and other media outlets about their study. In December 2016, the group released an update that reviewed what actions the US government had taken with respect to their recommendations. Perhaps not surprisingly, the overwhelming majority of recommendations had not been acted upon.
These two groups are bipartisan in their membership, so political bias is probably not the issue. It’s a narrow and highly technical focus, and their main mantra is essentially, “The threat is REAL—the government is not doing enough.” No one’s arguing whether biological threats exist. But there are many public policy challenges that require resources, and there are higher priorities. Advocacy groups have a habit of overstating their concerns and creating a false state of urgency in the interests of galvanizing government action. Creating an agenda and gaining support for new legislation takes time, and perhaps this issue has finally matured.
But is a new national biodefense strategy the answer? A recent article on the “proliferation” of national strategies suggests that strategic guidance only adds to the confusion, allowing executive agencies to pick and choose what they want to implement. The real impact of budget decisions changes what was originally thought to be a rational strategy, complicated by disagreements by the working parties as to who is doing what during the implementation process. But the biodefense strategy has suffered from an even greater challenge—the lack of clear definitions and lines of authority.
Going back to Bossert’s statement at the Aspen Security Forum, he referenced the 2001 anthrax-filled letters, pandemic influenza outbreaks, genetic engineering research, and the Global Health Security Agenda. He didn’t reference the protection of US military forces against adversarial use of biological warfare agents. All of these fall under the area of “biodefense,” and there is no one agency that comprehensively addresses all of these threats. Because US government funding, authorities, and capabilities for biodefense reside in different agencies, it is very difficult to articulate objectives and responsibilities in one single strategy. There is no single point of authority to execute the strategy, and very often, no incentive to change given an inability to redirect resources or authorities.
The term “biodefense” used to be relegated to protection of US military forces against biological weapons, but today it covers everything that is a biological threat, and therefore, it covers nothing to any adequacy in terms of policy direction. We have biosafety, which includes steps taken to prevent the large-scale loss of biological organisms from laboratories. This is not to be confused with biosurety, which adds the element of personnel reliability and agent accountability to biosafety. There are biopreparedness activities intended to prepare for public health emergencies, and biosecurity measures focused on protecting individuals from exposure to harmful biological agents. These are very different programs with very different policy agendas.
Then there’s biosurveillance—a term that people would think means the gathering, interpretation, and communication of data on biological threats to people. But health officials actually have a much broader definition in mind. Biosurveillance includes all potential threats—chemical, radiological, biological, conventional—that might cause health threats to humans, to include animal diseases and plant health. The US military has a big stake in this area, and not merely because of the threat of biological weapons that might be used against deployed military and civilian personnel. Natural diseases and non-battle injuries used to cause the majority of casualties during military operations, and still require significant planning to prevent a loss of operational capability in overseas operations.
The Defense Department spends billions of dollars on force health protection, which includes health surveillance—in fact, there’s an Armed Forces Health Surveillance Branch under the Defense Health Agency that tracks injuries and illnesses across the globe. Don’t ask why the term “biosurveillance” is used in the same exact manner and discussions as “health surveillance” unless you really want to face the intricacies of bureaucratic talk and arcane agendas. There’s also the Centers for Disease Control’s Emergency Operation Center and the DHS National Biosurveillance Integration Center that support the flow of information on health and disease events across the nation and world. These federal agencies already work well with each other—obviously improvements in capability can always be made, but does that mean that a new biodefense strategy needs to push those improvements?
The US Army has the heaviest investment among the four armed branches of the military in terms of personnel and resources in chemical and biological defense programs and for biosecurity and biosafety programs. In fact, the Army is the DoD Executive Agent for all three areas. One of the Army’s challenges (and by extension, the Defense Department’s problem) is its inability to clearly delineate whether a chemical or biological hazard is a “weapon of mass destruction” or just an incidental threat. The DoD Chemical and Biological Defense Program is chartered to develop medical countermeasures for biological weapons, mostly through Army labs at Fort Detrick. There is a separate Army medical research and development program to develop countermeasures against natural infectious diseases. Definitions became an issue when the DoD Chemical and Biological Defense Program decided to fund medical programs for influenza flu outbreaks and monitoring public health data in South Korea over established requirements associated with chemical and biological defense for military forces.
The Department of Health and Human Services is supposed to be the lead government agent for addressing public health concerns, to include naturally occurring diseases. HHS also supports the development of medical countermeasures to respond to biological terrorism threats, an effort that is coordinated with the research undertaken by the Defense Department. In addition, HHS is the lead for the Global Health Security Agenda, but somehow this became a national security issue that became tied with countering WMD (further complicating the policy/strategy discussion). HHS had a charter to build three advanced development and manufacturing centers to ensure a supply of medical countermeasures for the federal response to chemical, biological, or radiological incidents, given concerns raised during the pandemic outbreaks between 2004 and 2009. These are highly sophisticated labs working under a “private-public” partnership with the US government. The DoD Chemical and Biological Defense Program liked that idea so much that it created its own advanced development and manufacturing medical facility in Florida, despite the obvious duplication of effort and infringement into HHS areas of interest.
I’ve made the argument previously that there cannot be one national biodefense strategy because there are at least three distinct policy areas that, while overlapping, are significantly different in execution of their policy objectives. There is a biodefense program that is threat-driven, designed to protect US military forces from adversaries using biological warfare agents against them. There is a biosafety program that is information-driven, with the aim of protecting US citizens and military personnel during peacetime from “all hazards” to include natural diseases and accidents resulting in exposure to biological organisms. There are global biosecurity efforts that are intelligence-driven for the purpose of arms control and anti-terrorism, designed to track and assess labs, people, and disease outbreaks across the globe. These three distinct efforts share information and technology, but require separate policy approaches to be successful.
I am not optimistic that the US government will consider a more diverse and complex policy process that articulates these differences. Having one national biodefense strategy offers a façade of simplicity and organization that three separate strategies will not. The medical community (military and non-military) will not argue against a single national biodefense strategy as long as it means more resources to put against more diseases. The public health advocates will continue to use the specter of biological terrorism as a way to get more resources for naturally occurring diseases—understandably, as naturally occurring diseases still kill hundreds of thousands more people than bioterrorism incidents do. But to use the generic term “biodefense” to describe all of these disparate activities is not good public policy, and it should not be trumpeted as progress against all biological threats.
The United States is better prepared for responding to biological threats than the critics suggest, but could benefit from clearer policy on how it prepares for and executes biodefense, biosafety, and biosecurity. The US military in particular needs to re-examine its own strategies and programs to ensure that the right capabilities are developed to support its forces in the field against all biological threats. The question is, will the policymakers have the willingness to unscramble all of these intertwined efforts and articulate a coherent strategy with actionable outcomes?
