The National Biodefense Strategy and Implementation Plan released by the White House on Tuesday outlines steps intended to better detect biothreats, prevent the spread of outbreaks and improve lab security, stop bioterror attacks, prepare for the impacts of bioincidents, and rapidly respond and recover from biological events with a focus on helping critical infrastructure and the supply chain withstand impacts.
President Biden also signed National Security Memorandum-15 to implement the strategy and coordinate biodefense across federal agencies under oversight from the National Security Advisor. Departments will also be required to prioritize biodefense in their budgets and exercise bioincident response, and the memorandum also directs the intelligence community to track evolving biothreats.
“The risk of another pandemic as bad or worse than COVID is a real threat,” a senior administration official told reporters in advance of the strategy’s release. “Some modelers predict that that could happen within the next 25 years, if not sooner.”
Biological threats, whether they are naturally occurring, accidental, or deliberate in origin, “are among the most serious threats facing the United States and the international community,” the strategy says. “Advances in life sciences and biotechnology promise better and faster cures, economic advances, a cleaner environment, and improved quality of life, but they also bring new security risks that must be managed. In this rapidly changing landscape, the United States must be prepared to manage the risks posed by natural outbreaks of disease, accidents with high-consequence pathogens, or adversaries who wish to do harm with biological agents.”
“Multiple nations have pursued clandestine biological weapons programs, and a number of terrorist groups have sought to acquire biological weapons,” the report notes. “In addition, advances in biotechnology, including synthetic biology, are making it easier to develop and use biological agents as weapons. In many countries around the world, pathogens are stored in laboratories that lack appropriate biosecurity measures and could be diverted by actors who wish to do harm. Further, thousands of clinical samples generated during an epidemic can pose a biosecurity vulnerability if handled without appropriate security considerations, potentially facilitating access to materials and information that could be used in the development of a biological weapon.”
The new strategy is an update to the National Biodefense Strategy issued by the White House in September 2018. In February 2020, the Government Accountability Office assessed that “challenges with planning to manage change, limited guidance and methods for analyzing capabilities, and lack of clarity about decision-making processes, roles, and responsibilities” imperiled successful implementation of the plan to protect the country from biothreats.
The 2018 National Biodefense Strategy, a multiagency effort overseen by the Department of Health and Human Services, was issued with the goal of “a more efficient, coordinated, and accountable biodefense enterprise” established by setting up “a process to assess our capabilities and to prioritize biodefense resources and actions across the government.” The strategy built on “lessons learned from past biological incidents to develop a more resilient and effective biodefense enterprise” including the 2001 anthrax attacks, the 2009 influenza pandemic, the 2014 Ebola epidemic, and the Zika epidemic.
The updated strategy incorporates lessons learned from the COVID-19 pandemic, in which “every individual, community, and nation has experienced firsthand the health, social, and economic crises biological incidents can cause and the severe impact they can have on lives and livelihoods.”
“The COVID-19 response has illuminated both longstanding and newly discovered limitations in local, national, and international biodefense capabilities. It has also resulted in the unparalleled mobilization of citizens, nations, and diverse sectors, and galvanized innovation to address a global biological threat,” the strategy states. “The pandemic has demonstrated the urgent need for sustained investment and coordination across the U.S. Government, private and nonprofit sectors, SLTT entities, our international partners and organizations, and our communities to assess, prevent, prepare for, respond to, and recover from future biological incidents.”
The mission of the federal government during a biological incident — in coordination with state, local, tribal, and territorial governments along with international partners, the private sector, and academia — is “to save lives; reduce human and animal suffering; protect property and the environment; control the spread of disease; support community efforts to overcome the physical, emotional, environmental, and economic impact of the incident; and determine the cause and source of the incident.”
In furtherance of the central aim of managing biological risk, the strategy recognizes that “biological threats are persistent,” originate from multiple sources, “do not respect borders” as seen with the COVID-19 pandemic and other outbreaks, can have “severe impact” on critical infrastructure and supply chains, and must be confronted with whole-of-government and whole-of-society engagement.
The National Biodefense Strategy is built on five goals and related objectives with the intent of strengthening the biodefense enterprise. The first is to “enable risk awareness and detection to inform decision-making across the biodefense enterprise,” building “risk awareness at the strategic level through analyses and coordinated research efforts to characterize naturally occurring, accidental, and deliberate biological risks; and at the operational level through One Health surveillance and detection activities to detect and identify biological threats and anticipate biological incidents.”
The objectives in the first goal are to “ensure decision-making is informed by intelligence, forecasting, and risk assessment” and “ensure that domestic and global biothreat detection, biosurveillance, and information systems are coordinated, integrated, and capable of enabling timely bioincident prevention, detection, reporting, assessment, response, and recovery.”
The second goal is to “ensure biodefense enterprise capabilities to prevent bioincidents,” including preventing the spread of naturally occurring infectious diseases, minimizing the risk of laboratory accidents “both domestically and globally,” and strengthening biosecurity “to prevent both state and non-state actors from obtaining or using biological material, equipment, and expertise for nefarious purposes, consistent with the U.S. Government’s approach to countering weapons of mass destruction.”
“Implementing Goal 2 will ensure we have the capabilities necessary to disrupt plots, degrade technical capabilities, and deter support for state and non-state actors seeking to use biological weapons,” the strategy states. “This goal also recognizes the dual-use nature of the life sciences and biotechnology, in which the same science and technology base that improves health, promotes innovation, and protects the environment can also be misused for harmful purposes. Domestically and internationally, the United States seeks to prevent the misuse of science and technology while promoting and enhancing its legitimate use and innovation.”
Objectives to meet this goal are to “promote measures to prevent or reduce the spread of infectious diseases; strengthen global health security capacities internationally to prevent local bioincidents from becoming epidemics; deter, detect, degrade, disrupt, deny, or otherwise prevent nation-state and non-state actors’ attempts to pursue, acquire, or use biological weapons, related materials, or their means of delivery; strengthen biosafety and biosecurity practices and oversight to prevent bioincidents and reduce biological risks associated with life sciences research and development and advances in biotechnology.”
The National Biodefense Strategy’s third goal is to “ensure biodefense enterprise preparedness to reduce the impacts of bioincidents,” including “maintaining a vibrant national science and technology base to support biodefense; promoting a strong domestic and international public, veterinary, and plant health infrastructure; developing, updating, and exercising response and recovery capabilities; establishing risk communications; developing and effectively distributing and dispensing countermeasures; and collaborating across the country and internationally to support biodefense.”
The third goal’s objectives are to “promote a vibrant, safe, and secure domestic and international science and technology base, including in biotechnology and biomanufacturing, to support biodefense; ensure a strong public, veterinary, and plant health infrastructure; develop, exercise, and update prevention, response, and recovery plans and capabilities, including efforts to secure critical supply chains; develop, exercise, and update risk communication plans and promote consistent, plain language messaging to inform key audiences, expedite desired response actions, and address public uncertainty and fear; enhance preparedness to save lives through development, testing, evaluation, manufacturing, regulatory approval, distribution, and administration of countermeasures; enhance preparedness to limit the spread of disease through community mitigation measures; enhance preparedness to support decontamination, waste management, environmental controls, and other methods of suppressing pathogens during a biological event; strengthen preparedness to operate and collaborate across the United States, including the U.S. territories; strengthen international preparedness to support international response and recovery capabilities.”
The fourth goal is to “rapidly respond to limit the impacts of bioincidents” through “information sharing and networking; evidence-driven, coordinated response operations and investigations; effective public messaging; and research.” The stated objectives to reach this goal are to “compile and share biothreat, bioincident, and response information to enable appropriate decision-making and response operations across all levels of government and with nongovernmental, private sector, and international entities, as appropriate; conduct evidence-driven federal response operations and activities and implement a federal research agenda in coordination with relevant nongovernmental, private sector, and international partners where appropriate to contain, control, and rapidly mitigate impacts of biothreats or bioincidents; conduct operations and investigations, and use all available tools to hold perpetrators accountable; execute risk-informed, accurate, timely, and actionable science-driven risk communications and community engagement.”
The fifth and final goal of the strategy is to “facilitate recovery to restore the community, the economy, and the environment after a bioincident” with the intent to “minimize cascading effects.” Objectives aligned with this goal are to “promote restoration of critical infrastructure capability and capacity to enable the resumption of vital U.S. activities; ensure coordination of recovery activities across all levels of government and with nongovernmental, private sector, and international entities, as appropriate, to enable effective and efficient recovery operations; provide recovery support and conduct long-term mitigation actions to promote resilience; reduce the cascading effects of international biological incidents on the global economy, health, and security.”
One senior administration official emphasized before the release of the strategy that COVID-19 taught that “we need to be able to move much faster to counter pandemic threats, and we also need to be prepared for completely unknown threats — so not just the things we know, but the things we don’t know.”
“Currently, there are 26 families of viruses that are known to infect humans, many of which we are far less prepared for than coronaviruses,” the official added.
