RETHINKING U.S. BIOSECURITY STRATEGY FOR THE DECADE AHEAD

Annotated Bibliography

October 27-29, 2020

Center for Global Security Research LAWRENCE LIVERMORE NATIONAL LABORATORY

Annotated Bibliography

RETHINKING U.S. BIOSECURITY STRATEGY FOR THE DECADE AHEAD

Center for Global Security Research Livermore, California, October 27-29, 2020

Prepared By: Lauren J. Borja, Marigny Kirschke-Schwartz, Ryan Swan

Key Questions:

 What lessons should be drawn from the COVID 19 crisis for the future of U.S. biosecurity strategy?  What bio-related threats, risks, and dangers must be accounted for in the decade ahead?  How can the coherence of national and international responses be improved?

Panel Topics:

1. The Challenge of Anticipating Emerging Threats 2. The Challenge of Responding to an Emergent Threat 3. Biological Warfare 2030 4. Public Health Risks 2030 5. Balancing Pandemic Preparedness and Biodefense 6. Balancing Oversight and Execution

The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States government or Lawrence Livermore National Security, LLC, and shall not be used for advertising or product endorsement purposes.

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Panel 1: The Challenge of Anticipating Emerging Threats

 What methodologies and toolkits were used to characterize pandemic risk? Can they be improved? How?  What preparations are appropriate for Black Swan events?  Do we have adequate means to “connect the dots” between information source divided between public health and national security domains?

Cameron, Elizabeth; Nuzzo, Jennifer B.; Bell, Jessica A.; et al, “2019 Global Health Security Index: Building Collective Action and Accountability,” Nuclear Threat Initiative and Johns Hopkins, Bloomberg School of Public Health, Center for Health Security, October 2019, https://www.ghsindex.org/wp-content/uploads/2020/04/2019-Global-Health-Security-Index.pdf

The Global Health Security (GHS) Index serves as a comprehensive assessment and benchmarking of health security and related capabilities across the 195 states parties to the International Health Regulations. It notes an increasing risk of high consequence and globally catastrophic risks, magnified by a rapidly changing and interconnected world in which increasing political instability, urbanization, climate change, and rapid technology advances make it easier, cheaper and faster to create and engineer pathogens. The Index considers the broader context for biological risks, including a country’s geopolitical considerations, health system and whether it has tested its capacities to contain outbreaks.

Morse, Stephen S.; Mazet, Jonna A.K.; Woolhouse, Mark; et al. “Prediction and prevention of the next pandemic,” The Lancet, 2012, https://doi.org/10.1016/S0140-6736(12)61684-5

The authors review the research literature of zoonoses, or infectious diseases caused by pathogens that have jumped from animals to humans. The authors discuss a model for zoonotic events and describe characteristics of places where an event might occur. They assess the current state of public health research efforts toward developing the ability to better predict infectious pathogens that could crossover from animals to humans. The authors also call for increased collaboration across different public health entities to better predict or reduce the impact of emerging pathogens.

Schoch-Spana, Monica; Cicero, Anita; Adalja, Amesh; et al, “Global Catastrophic Biological Risks: Toward a Working Definition.” Health Security, 2017, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5576209/pdf/hs.2017.0038.pdf

The authors present their working definition of global catastrophic biological risks (GCBRs), which they see as a subset of global catastrophic risks. They enumerate some defining characteristics and elements of GCBRs and apply them to past and future biological risk scenarios. The authors conclude that while GCBRs represent a small portion of biological threats in the world and should not distract from work to prevent and respond to other vital disease priorities, GCBRs pose such extraordinary potential consequences for humanity that they deserve their own high-level attention, risk assessment, resources, and strategic planning. 2

U.S. Department of Health & Human Services, “National Influenza Vaccine Modernization Strategy (NIVMS) 2020-2030”, 2020. https://www.phe.gov/Preparedness/planning/nivms/Documents/nivms-2020-2030.pdf

As directed by Executive Order 12887, the National Influenza Vaccine Modernization Strategy outlines a vision for the U.S. influenza vaccine enterprise to become more responsive, flexible, resilient, scalable, and more effective at reducing the impact of seasonal and pandemic influenza viruses in line with three overarching strategic objectives: 1) strengthen and diversify influenza vaccine development, manufacturing, and supply chain; 2) promote innovative approaches and use of new technologies to detect, prevent, and respond to influenza; and 3) increase influenza vaccine access and coverage across all populations.

Panel 2: The Challenge of Responding to an Emergent Threat

 In the local and national level responses, what should and could have been done differently?  In the international responses, what could and should have been done differently?  In global perspective, who got it right? How did they do so?

Summary of remarks by Bentz, Julie, “Chapter 1: Capabilities for Effective Response to an International CBRN Event” in National Research Council’s An All-of-Government Approach to Increase Resilience for International Chemical, Biological, Radiological, Nuclear, and Explosive (CBRNE) Events: A Workshop Summary. 2014. https://doi.org/10.17226/18814

In her remarks, Bentz offers four suggestions for responding to an international chemical, biological, radiological, or nuclear (CBRN) event, informed by the 2011 nuclear disaster in Fukushima, Japan. She first suggests the development of improved inter-government coordination for low-probability, high-impact events, asserting that traditional mechanisms are insufficient when additional layers of government are added to the process. Second, she calls improving the mechanisms for sharing technical data. Third, she advocates for new definitions of metrics for success and consequence management. Finally, Bentz calls for the structuring of procedures for evacuating U.S. personnel and citizens from foreign territories hit by a CBRN event.

Currie, Chris P., “COVID-19 FEMA's Role in the Response and Related Challenges” Statement before the Subcommittee on Oversight, Management, and Accountability, and the Subcommittee on Emergency Preparedness, Response, and Recovery, Committee on Homeland Security, House of Representatives, July 2020, https://www.gao.gov/assets/710/708097.pdf

Currie’s testimony focuses on FEMA’s role in managing the COVID-19 pandemic. He discusses efforts to acquire and distribute critical medical supplies as well as what these and prior efforts suggest about potential challenges going forward for the ongoing COVID crisis and future nationally significant biological incidents. Based on FEMA’s work 3

between 2003 and 2020, he highlights key challenges. These include coordination between FEMA and federal and state agencies, medical supply acquisition and distribution, deployment of disaster workforces, after-action reporting, inter-agency planning, and assessment of capabilities.

Ghilarducci, Mark. “Reviewing Federal and State Pandemic Supply Preparedness and Response,” Testimony before the U.S. House of Representatives Committee on Homeland Security, Subcommittee on Oversight, Management, and Accountability, Subcommittee on Emergency Preparedness, Response, and Recovery, July 2020, https://homeland.house.gov/download/ghilarducci-testimony-oma-71420

Ghilarducci, the Director of California Governor’s Office of Emergency Services, testifies on the federal government’s procurement and distribution of personal protective equipment and testing supplies during the COVID-19 pandemic. First, he summarizes California’s response to several emerging state crises in the spring of 2020, noting interactions between the state and federal government during this time. He also summarizes efforts made by the state of California to develop its own response and address deficiencies in federal government support. He concludes with several recommendations for the U.S. government to improve its current and future pandemic response strategy.

Greenberg, Karen J. and Schwartz, Amanda E., “Report #1: COVID-19 Detection and Response” for Center on National Security at Fordham Law, August 2020, https://www.centeronnationalsecurity.org/s/Biosecurity-Report-1-Aug-10-2020.pdf

The authors of this report examine the experiences of six countries in confronting the COVID-19 pandemic: the United States, the United Kingdom, Germany, South Korea, New Zealand, and China. The authors discuss the successes and failures of these countries in countering COVID-19, compares their preparedness regimes and the in-time responses of each government to assess which governance-related factors are the most critical to success at the domestic level. They identify four necessary factors for countering the spread of the pandemic: 1) strong central leadership and inter-agency coordination; 2) adaptable pre-exiting pandemic strategy and implementation plan; 3) regard for societal and cultural factors; and 4) a strict lockdown and/or effective data-driven measures

National Research Council 2016 “Chapter 6: Building a framework for global health security” in The Neglected Dimension of Global Security: A Framework to Counter Infectious Diseases Crises, 2016. https://doi.org/10.17226/21891

In this chapter, the Council first recognizes the scale of risk posed by infectious diseases to human life and economic well-being, before contemplating a resilient and more protective framework. The Council calls for a large commitment of $4.5 billion annually from the global community to rectify deficiencies in local health systems, enhance global capabilities and coordination and accelerate research and development. The chapter enumerates some challenges with the financing of this initiative: 1) there is no robust assessment of the gaps in national core capacities for infectious disease prevention and

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detection; 2) much of the incremental spending on national health systems relates to capabilities and infrastructure that are also required to mount an effective response to other health issues; 3) some elements of the incremental spending proposed are necessarily subjective, with a large element of uncertainty in their determination; and 4) the cost of the WHO contingency and World Bank pandemic emergency financing depend on the financing structure, how often they are utilized and whether the funds are deployed as loans or grants.

Panel 3: Biological Warfare 2030

 What countries are violating the ban on biological weapons? With what known activities? What might technological developments make possible for them?  What are the prospects for bioterrorism? Biocrime?  Can biodefense keep up?

Berger, Kavita M.; DiEuliis, Diane; Meyer, Corey; and Rao, Venkat; “Roadmap for Biosecurity and Biodefense Policy in the United States,” 2018, https://wmdcenter.ndu.edu/Portals/97/Documents/Publications/1A%20Full%20Report.pdf?ver= 2018-06-27-110035-457

The authors survey efforts in the US government around biotechnology funding and policy, which are broadly divided into two efforts around biosecurity and biodefense. The authors find that there is a lack of assessment of both gaps in and implementation of US government biotechnology policies. To address these shortcoming, the authors develop a roadmap based on six cyclic actions and identify stakeholders in US government agency, biological research and health fields who might be responsible for contributing to or leading the suggested actions. Special attention is given to the role of the US Department of Defense.

Ben Ouagrham-Gormley, Sonia, “Dissuading Biological Weapons Proliferation,” Contemporary Security Policy, 2013, https://doi.org/10.1080/13523260.2013.842294

Ben Ouagrham-Gormley argues against current US biodefense policy, because it inflates the threat of bioweapons and is therefore more likely to persuade, rather than dissuade, the development of bioweapons. The author argues that biological agents, contrary to how they are presented in most biodefense narratives, are challenging to weaponize and that this process requires skills and knowledge beyond the acquisition of biotechnology alone. The author advises targeting knowledge rather than biotechnology materials to form a more dissuasive policy.

Bipartisan Commission on Biodefense. “A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts.” Oct 2015, https://biodefensecommission.org/reports/a-national-blueprint-for-biodefense/

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This report analyzes four components of biodefense: threat awareness; prevention and protection; surveillance and detection; and response and recovery. The authors identify places where the US government can improve its biodefense capability through thirty- three recommendations over the short-, middle-, and long-term time frames. Many of the gaps in US biodefense policy can be attributed to a lack of centralized leadership and, consequently, collaboration across different government agencies and stakeholders. The report calls for the Vice President to fill the role as leader for various US biodefense efforts.

Koblentz, Gregory D., “Regime Security: A New Theory for Understanding the Proliferation of Chemical and Biological Weapons,” Contemporary Security Policy, 2013, https://doi.org/10.1080/13523260.2013.842298

Koblentz argues that the discourse on chemical and biological weapons should be expanded beyond external security threats to also include internal or domestic security. Citing examples from history such as the Soviet Union’s use of toxins and Iraq’s use of chemical weapons against a Kurdish revolt, the author introduces a theory of regime security to the chemical and biological weapons scholarship. Policymakers would benefit by taking these motives into account when designing nonproliferation strategies for chemical and biological weapons. Koblentz also poses questions for further study.

National Academies of Science, Engineering and Medicine, “Summary” of Biodefense in the Age of Synthetic Biology, 2018, https://doi.org/10.17226/24890

In this report, the authors develop a framework for assessing the level of concern for emerging capabilities in synthetic biology. The potential threat due to weaponization of these capabilities is ranked based on relative concern. Furthermore, the authors list barriers, bottlenecks and potential developments that could be monitored to assess progress towards developing bioweapons using synthetic biology.

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Panel 4: Public Health Risks 2030

 Over the coming decade, are public health crises likely to become more or less frequent? Why?  Can public health responses reduce their expected impact?

DiMaio, Daniel; Enquist, Lynn W.; and Dermody, Terence S.; “A New Coronovirus Emerges, This Time Causing a Pandemic,” Annual Review of Virology, September 2020, https://doi.org/10.1146/annurev-vi-07-042020-100001

The authors place the then-emerging COVID-19 pandemic in the context of other pandemics from history and other recent widespread respiratory infections, such as severe acute respiratory syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Research efforts from these recent respiratory infections will provide groundwork for combating the current outbreak. The authors also list important lessons from the current pandemic.

Hoffman, Stephen J. and Silverberg, Sarah L., “Delays in Global Disease Outbreak Responses: Lessons from H1N1, Ebola, and Zika,” American Journal of Public Health, https://doi.org/10.2105/AJPH.2017.304245

The authors find that for recent pandemics—H1N1, Ebola, and Zika—delays in global responses are largely due to a lack of political mobilization by world health leaders and not initial detection of the disease. Faster global health mobilization could be observed due to disease novelty, greater ease of transmission, not spread during holiday seasons, and impact on U.S. citizens. Severity of the disease, number of countries affected, and the number of people at risk did not lead to a faster global health response.

Holmes, King K.; Bertozzi, Stefano; Bloom, Barry R.; et al, “Ch 1: Major Infectious Diseases: Key Messages from Disease Control Priorities, Third Edition”, 2017, https://www.ncbi.nlm.nih.gov/books/NBK525197/

While global health organizations have made progress towards reducing infectious disease deaths worldwide, several factors, such as cost barriers to healthcare access or antimicrobial resistance, impede the prevention and treatment of such diseases. The authors group interventions conceptually and logistically for different levels of public health providers. These recommendations are provided for HIV and other sexually transmitted infections, tuberculosis, malaria and other adult febrile illness, viral hepatitis, and neglected tropical diseases. The authors identify four main challenges toward progress against infectious diseases.

Kapiriri, Lydia and Ross, Alison, “The Politics of Disease Epidemics: A Comparative Analysis of the SARS, Zika and Ebola Outbreaks,” Global Social Welfare, 2020, https://doi.org/10.1007/s40609- 018-0123-y

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The authors analyze peer-reviewed medical, social, and political articles to assess narratives surrounding three recent pandemics within different socioeconomic, geographical, and cultural contexts. Their analysis compared the 2003 SARS outbreak in Toronto, Canada, the 2014 Ebola outbreak in Liberia, and the 2015 Zika outbreak in Brazil. The authors identified four themes in their literature search: socioeconomic distribution of the disease, decision-making in research and development, credibility of evidence that informs response pathways, and attribution of infectious disease responsibility. Despite the fact that poor and marginalized communities experience higher levels of vulnerability to pandemics, the authors found only a limited discussion of the role of social and economic inequality in the public health literature from an affected region.

Panel 5: Balancing Pandemic Preparedness and Biodefense

 How should that balance be struck?  How much preparedness is enough? Why?

Cross, Glen and Klotz, Lynn, “Twenty-first century perspectives on the Biological Weapon Convention: Continued relevance or toothless paper tiger,” Bulletin of Atomic Scientists, July 2020, https://doi.org/10.1080/00963402.2020.1778365

The COVID-19 pandemic has inspired new critiques of the Biological Weapons Convention and reassessments of the norm against the use of biological weapons. Drawing on the limited historical uses of biological weapons, Cross and Klotz propose that the BWC was successful in establishing a near-universal norm. The authors conclude that the COVID-19 pandemic underscores the futility of biological weapons, further strengthening the norm.

Ford, Christopher, “Biosecurity, Biological Weapons, Nonproliferation, and Their Future,” remarks at the US National Defense University, April 2019, https://www.state.gov/biosecurity- biological-weapons-nonproliferation-and-their-future/

In his remarks, Assistant Secretary of the Bureau of International Security and Nonproliferation summarizes the U.S. National Biodefense Strategy, emerging biosecurity threats and anticipated biosecurity threats. He names non-state and state actors who have or are currently pursuing biological weapons programs. Ford discusses the role of the Bureau of International Security and Nonproliferation in coordinating the U.S. government’s response to biological weapons. He talks about the role of plausible deniability in recent uses of chemical weapons, noting that this trend could also be seen in future biological weapon attacks.

Gerstein, Daniel M. “Assessing the US government response to the coronavirus,” Bulletin of the Atomic Scientists, July 2020, https://doi.org/10.1080/00963402.2020.1778356

In a critique of the U.S. government’s response to the COVID-19 pandemic, Gerstein identifies important shortcomings at the intersection of U.S. biodefense and public health. Noting the failure to follow emergency response doctrine, Gerstein argues that

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weak federal leadership, poor communication with the public, and shortfalls in critical resources contributed to the lack of preparedness in the U.S. coronavirus response.

Parker, Gerald W.; Blackburn, Christine Crudo; and Nastios, Andrew S., “The Growing Threat of Pandemics: Enhancing Domestic and International Biosecurity” A Snowcroft Institute of International Affairs White Paper, March 2017, https://bush.tamu.edu/wp- content/uploads/2020/07/The-Growing-Threat-of-Pandemics.pdf

This paper identifies nine priority areas to improve domestic and international biosecurity. The authors maintain that the current U.S. strategy for pandemic response is reactive rather than preventive and suggest organizational changes to improve long-term effectiveness. Notable recommendations call for stronger leadership and centralization between the U.S. organizations tasked with pandemic response, emergency funding authorities for the Department of Health and Human Services, and robust diagnostic capabilities.

The White House, “National Biodefense Strategy,” 2018, https://www.whitehouse.gov/wp- content/uploads/2018/09/National-Biodefense-Strategy.pdf

The National Biodefense Strategy, released by the Trump administration, presents the purpose, anticipated threats and consequences, risk management strategy, assumptions and proposed governance structure for countering biological threats in the U.S. government. Five goals, with objectives for accomplishing them, are discussed. These goals form a National Biodefense Strategy Implementation Plan.

Panel 6: Balancing Oversight and Execution

 What is the proper and necessary role of scientific expertise?  How much and what kind of oversight is necessary for effective policy execution?

DiEuliis, Dianne; Lutes, Charles D.; Giordano, James, “Biodata Risks and Synthetic Biology: A Critical Juncture,” Journal of Bioterrorism & Biodefense, 2018, https://doi.org/10.4172/2157- 2526.1000159

In this article, the authors argue that the digitization of biodata has created new risks concerning the overlap of biological and information security. The challenges inherent in formulating effective policy options for pathogen, manufacturing, and biodata privacy concerns demonstrate the need for discussion in international forums.

Franz, David, “The Dual Use Phenomenon: Crying out for Leadership”, St. Louis Journal of Health Law and Policy, (2013). https://scholarship.law.slu.edu/jhlp/vol7/iss1/4

In this comprehensive assessment of the development of U.S. biosafety principles, Franz asks whether increased regulation of biological laboratories has led to increased security. The changes made after 9/11 and the ‘Amerithrax’ attacks created new layers of 9

questionably effective biosafety regulations. Informed by a career on U.S. regulatory and verification committees, Franz argues that strong leadership and a culture of corporate responsibility can help mitigate the risks posed by dual-use research of concern and insider threats.

Lentzos, Filippa; Goodman, Michael S.; and Wilson, James M., “Health Security Intelligence: engaging across disciplines and sectors,” Health Security Intelligence, 2020 https://doi.org/10.1080/02684527.2020.1750166

This article evaluates how perceptions of health security threats have changed over time to include both deliberate and natural disease outbreaks. The authors assert that the expansion of the threat spectrum requires a multidisciplinary approach and suggest increased collaboration between non-security stakeholders, scholars, and state-based structures to improve health intelligence.

National Academies of Sciences, Engineering, and Medicine, “Summary” in Safeguarding the Bioeconomy, 2020, https://doi.org/10.17226/25525

This report defines, assesses, and identifies risks in the U.S. bioeconomy, or the economic activity related to research and innovation in U.S. biotechnology and life sciences. Several recommendations are offered to better understand, develop economic metrics for, and encourage federal leadership in the U.S. bioeconomy. The report also recommends engaging with international organizations to develop the global bioeconomy.

Weiss Evans, Sam; Beal, Jacob; Berger, Kavita; et al, “Embrace experimentation in biosecurity governance,” Science, 2020, https://doi.org/10.1126/science.aba2932

New approaches to governance in biosecurity are traditionally sporadic responses to policy failures or biological incidents. In this article, the authors frame biosecurity governance as an ongoing experiment that requires periodic reassessment and forward thinking. With an emphasis on sharing failures and increased collaboration between the public and private sector, the authors argue that biosecurity governance should move past a reactive approach and reevaluate existing biosecurity structures.

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Center for Global Security Research Lawrence Livermore National Laboratory P.O. Box 808, L-189 Livermore, California 94551 https://CGSR.llnl.gov

This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344. LLNL-TR-815198 1