What should the US national biodefense strategy look like?

By Laura H. Kahn | November 8, 2017

Like many other countries, the United States faces a wide range of growing biosecurity threats, from pandemics to laboratory accidents to deliberate attacks by governments, militant groups, and even rogue individuals. Currently, a hodgepodge of federal agencies deals with these dangers, with no one person or entity effectively in charge of biosecurity. Back in 2004, a presidential directive assigned responsibility for coordinating operations against bioterror attacks to the Department of Homeland Security (DHS). In theory, this made sense, but in practice, it didn’t work out so well. In 2009, then-DHS Secretary Janet Napolitano took charge of the interagency response to the H1N1 influenza pandemic. The DHS had only limited success in coordinating interagency efforts, making last-minute changes to previously established plans and forcing the White House to take charge. In 2015, the Blue Ribbon Study Panel on Biodefense concluded that the United States still needed a single coordinated biodefense strategy.

Today, it looks like America may finally be getting one. In late 2016, Congress enacted the National Defense Authorization Act for fiscal year 2017, requiring four government agencies—the departments of Defense, Health and Human Services, Homeland Security, and Agriculture—to jointly develop a national biodefense strategy and implementation plan. As of September 2017 that effort was underway, overseen by the National Security Council. As a strategy takes shape, now is a good time to consider what a national biodefense strategy should look like, and what obstacles stand in the way.

What are the dangers? The Blue Ribbon Study Panel on Biodefense is a privately funded project—led by former Senators Joseph Lieberman and Tom Daschle, former Pennsylvania Governor Tom Ridge, and former Secretary of Health and Human Services Donna Shalala, among others—with the mission to assess the state of US biodefense efforts. Since its launch in 2014, it has issued several reports that give a good road map of what is needed for bio-defense and protecting the agricultural sector.

Biological threats are growing, according to the Panel’s initial 2015 report. The State Department assessed that five countries (China, Iran, North Korea, Russia, and Syria) have been failing to comply with the Biological Weapons Convention. Meanwhile, advances in science and technology, including the gene-editing technique CRISPR, enable would-be bioterrorists to develop novel biological threats with potentially catastrophic effects. Failing to predict these risks leaves the United States vulnerable.

The United States faces other biological threats too. Dangers introduced by wildlife can wreak havoc on livestock, ultimately affecting the food supply. The US agriculture industry is one of the largest sectors of the country’s economy, constituting about 5.5 percent of the gross domestic product. In October, the Blue Ribbon Study Panel issued a new report on the defense of animal agriculture. It found that a highly pathogenic strain of avian influenza, brought to the United States in December 2014 by migrating birds, cost the US economy a total of $3.3 billion, including the cost of slaughtering more than 50 million birds on 232 farms across 21 states. That outbreak occurred naturally. A bioterrorist attack designed to inflict as much damage as possible could be much more catastrophic.

The piecemeal nature of the American healthcare system also has national security implications, which have been exacerbated by the Trump administration’s efforts to undermine the Affordable Care Act. Having millions of people without access to healthcare while a deadly epidemic circulates through the population is akin to having only a few rooms of a house insured while a fire rages inside it.

What should be done? While the national biodefense strategy is bound to be broad in scope, a few strategies and approaches stand out as particularly important.

First, human-intelligence-based monitoring of rogue nations and militant groups that use bioweapons is critical. Nothing works better than eyes and ears on the ground. This highly dangerous work has to be done by intelligence professionals who place utmost trust in the US government to keep their work highly classified and provide protection in the event of discovery. The current administration does not appear to inspire that kind of confidence from the intelligence community.

Second, a national strategy must include a plan for disease surveillance of humans and animals, with a view to predicting the next naturally occurring epidemic. This kind of work is difficult, because there are so many viruses that could spill over from other mammals or birds into humans. Given limited resources, the government should be strategic regarding where it implements surveillance. Bats, rodents, and wild waterfowl are arguably the likeliest candidate species to harbor the next deadly pandemic pathogens.

Third, even the most secure laboratories are fallible, meaning that they pose risks stemming from accidents and lab-acquired infections. A US Army biodefense lab mistakenly shipped live anthrax to other labs for more than a decade. Centers for Disease Control (CDC) labs experienced a series of mishaps; in 2014, these accidents involved bird flu and anthrax. Since then, the CDC has made some progress on lab safety, but there is still no federal oversight for laboratory-acquired infections. (The CDC does do surveillance of infections, but not of those acquired in laboratories.) The National Institute for Occupational Safety and Health, while it tallies injuries and chemical exposures, likewise does not monitor laboratory-acquired infections. In other words, this is a problem that has fallen through the bureaucratic cracks and must be corrected.

Fourth, any national biodefense agenda should include plans to review the lab-oversight body known as the Federal Select Agent Program, subject of a new GAO report. At high-containment laboratories, scientists work on the extremely dangerous pathogens—such as Ebola and anthrax—known as “select agents.” Currently the Federal Select Agent Program, which is jointly managed by the Departments of Agriculture and Health and Human Services, oversees laboratories’ handling of these pathogens. But the GAO report found that the program has problems, including not being independent of all the labs it oversees, and consequently being vulnerable to conflicts of interest. The report also found that the program may not have formally assessed the risk level of some of its activities, and that it had gaps in its workforce and training. In short, there is room for improvement in the system meant to protect us from select agents.

Fifth, a national biodefense strategy should include the investigation of large-scale wildlife die-offs. Such events—like when thousands of crows died during a New York city West Nile virus outbreak in 1999—provide important clues that something in the environment is amiss. Investigations require the kind of expertise normally housed within the Environmental Protection Agency (EPA) and the US Fish and Wildlife Service (part of the Department of the Interior.)

Finally, a national biodefense strategy must recognize that human, animal, and environmental health are linked, and take a “One Health” approach to biological threats. A threat to one component in this triad threatens them all. For that reason, animal and environmental health must be taken just as seriously as human health—which requires devoting personnel and resources to monitoring them, which requires sufficient funding for entities like the EPA and the Fish and Wildlife Service.

Obstacles to good biodefense. Another new GAO report, this one called “Federal Efforts to Develop Biological Threat Awareness,” suggests that efforts to plan and implement a national biodefense strategy are on track. The report details the intelligence-gathering capabilities of the Departments of Defense and Homeland Security, and the global disease surveillance and research on biological agents that are being conducted by the Departments of Health and Human Services and Agriculture. However, other developments are not so reassuring.

Currently, according to the GAO report, each of five departments—the four mentioned above, as well as the EPA—conduct their own intelligence, laboratory work, and analysis on bioterrorism and biowarfare, including on agricultural threats and environmental contamination. They have interagency agreements and working groups that share information with each other, but they do not conduct threat analyses collaboratively. Gaps remain in shared efforts across the entire federal government’s biodefense enterprise. The agencies are also missing out on opportunities for sharing resources and lowering costs. The Department of the Interior, which is not mentioned at all in the GAO report, should also be a part of biodefense efforts, as it oversees wildlife health through the Fish and Wildlife Service.

Most distressingly, the current administration appears willfully ignorant of scientific issues, while at the same time disinclined to fund critical scientific efforts. The White House Office of Science and Technology Policy, which is intimately involved with biodefense issues, remains leaderless and understaffed. Meanwhile, Trump’s budget for fiscal year 2018 proposed significant cuts to the federal government’s biodefense efforts.

The cuts included eliminating funding for the National Biodefense and Countermeasures Center, which conducts threat characterization and analysis of potentially dangerous pathogens. Fortunately a bipartisan congressional amendment restored funding for the Center, but other biodefense efforts remain in peril. For instance, the proposed cuts could potentially jeopardize crucial disease surveillance work performed by the Laboratory Response Network. Established by a presidential directive and operational since 1999, the Network includes more than 150 state and local labs in public health, veterinary health, agriculture, food, and water testing, and provides extremely important surveillance against biological terrorism. It should remain a key part of the national biodefense strategy. Whether or not the Trump budget passes without further changes remains to be seen.

The National Security Council staff and leaders of the effort to draft a national biodefense strategy have an enormous opportunity to make a difference right now. The fact that we will soon have a coordinated strategy is a great reassurance. But planning mistakes or omissions could lead to grave dangers in the future. A comprehensive, One-Health-based strategy is essential for preparing for the next deadly biological threat.

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