---
title: "Biosecurity and National Security – The Biosecurity Handbook"
source: "https://biosecurityhandbook.com/foundations/biosecurity-national-security.html"
author: "Bryan Tegomoh, MD, MPH"
last_updated: "2026-11-04"
doi: "10.5281/zenodo.18252919"
license: CC BY 4.0
generated-by: handbook-markdown-export
---

# Biosecurity and National Security

A chemical release harms the people inside the plume and then disperses. A biological release can keep producing new cases after the attacker, the laboratory, or the spillover event has stopped acting, because the agent reproduces inside each person it infects and travels wherever that person travels. That difference, not lethality alone, is what makes biology a standing national security problem rather than a bounded emergency, and it is the reason the 2022 US National Biodefense Strategy opens by calling the management of biological risk a vital interest of the United States ([National Biodefense Strategy and Implementation Plan, October 2022](https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf)).

Learning Objectives

- Explain what national security means when the threat is biological rather than military.
- Distinguish the growth dynamics of biological events from the decaying hazard of chemical and radiological incidents, note where chemical, radiological, and nuclear consequences are also unbounded, and state what the difference implies for warning, attribution, and response.
- Summarize the historical record that policymakers reason from, including 1918, the 2001 anthrax letters, the Soviet Biopreparat program, and the measured costs of COVID-19.
- Describe the US biodefense architecture, its strategies, its principal agencies, and the direction of its budget.
- Describe the three international instruments that govern biological risk and their current status.
- Identify the open questions where analysts of good faith disagree.

Chapter Summary (TL;DR)

**The core argument:** Biological agents replicate. Chemical agents dilute and degrade and radioactive sources decay, so those hazards shrink from the moment of release even when their consequences travel far; a contagious biological event can expand after release through person-to-person transmission, incubation periods that hide the event from detection, and global travel that distributes cases before anyone knows there is an outbreak.

**What follows from that:** Warning must be epidemiological rather than perimeter-based, attribution is slower and sometimes impossible because an attack can look like a natural outbreak, the same equipment and knowledge serve medicine and misuse, and the natural, accidental, and deliberate pathways converge on the same defenses.

**What it costs:** WHO estimates 14.83 million excess deaths globally in 2020 and 2021, 2.74 times the 5.42 million COVID-19 deaths reported for the period ([Msemburi et al., *Nature*, 2023](https://pmc.ncbi.nlm.nih.gov/articles/PMC9812776/)). Cutler and Summers estimated the US cost of the pandemic at more than \$16 trillion, roughly 90% of annual US GDP, on assumptions set out in their 2020 analysis ([Cutler & Summers, *JAMA*, 2020](https://doi.org/10.1001/jama.2020.19759)).

**Where it sits in US policy:** The 2022 National Biodefense Strategy and National Security Memorandum-15 put coordination in the White House and cover natural, accidental, and deliberate events together. The National Security Commission on Emerging Biotechnology delivered 49 recommendations to Congress in April 2025 and asked for at least \$15 billion over five years ([CRS Insight IN12546, 17 April 2025](https://www.congress.gov/crs_external_products/IN/HTML/IN12546.html)).

**Where the money is going:** The Council on Strategic Risks, a think tank that advocates for biodefense investment, counts \$27.02 billion requested for biodefense across the federal government in the FY26 budget request, with HHS at \$19.44 billion, DoD at \$4.02 billion, and USDA at \$1.44 billion, each below FY25 enacted levels ([Council on Strategic Risks, December 2025](https://councilonstrategicrisks.org/2025/12/09/us-biodefense-budget-breakdown-fiscal-year-2026-update/)).

**Internationally:** The Biological Weapons Convention has no verification protocol. Amendments to the International Health Regulations entered into force on 19 September 2025. The WHO Pandemic Agreement was adopted in May 2025 but cannot open for signature until its pathogen access annex is adopted, and enters into force 30 days after the sixtieth ratification.

**Bottom line:** Biological risk belongs in national security planning because it is the only hazard in the CBRN set that can grow after release rather than decay, and because the defenses against a deliberate attack and against a natural pandemic are largely the same defenses. Chemical, radiological, and nuclear events are not confined to a radius either, and the comparison should be made on hazard growth rather than on geography.

## What National Security Means for Biology

National security describes the protection of a state’s population, territory, economy, and freedom of action against threats serious enough that ordinary civil systems cannot absorb them. Biology qualifies not because pathogens are uniquely lethal but because a biological event can exceed the capacity that a government holds in reserve for emergencies. The 2022 National Biodefense Strategy states this in its own terms: “Biological threats, whether naturally occurring, accidental, or deliberate in origin, are among the most serious threats facing the United States and the international community,” and it defines biodefense as “actions to counter biological threats, reduce biological risks, and prepare for, respond to, and recover from biological incidents, whether naturally occurring, accidental, or deliberate in origin and whether impacting human, animal, plant, or environmental health” ([National Biodefense Strategy and Implementation Plan, October 2022](https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf)).

Three features of that definition carry policy weight.

**Origin is not the organizing principle.** The strategy covers natural outbreaks, laboratory accidents, and deliberate attacks in one framework, on the reasoning that “a disease threat anywhere is a disease threat everywhere” and that “domestic action alone is insufficient to protect America’s health and security” ([National Biodefense Strategy and Implementation Plan, October 2022](https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf)). The United Kingdom’s 2023 strategy makes the same move, stating that biological threats “neither recognise nor respect political or geographic boundaries” and that, being naturally occurring and self-replicating, “they pose a unique threat to global security” ([UK Biological Security Strategy, 2023](https://www.gov.uk/government/publications/uk-biological-security-strategy/uk-biological-security-strategy-html)).

**Security is defined broadly.** The National Security Commission on Emerging Biotechnology, created by Congress in the FY22 National Defense Authorization Act, wrote that it understands national security “to encompass traditional defense issues as well as the broader considerations of economic resilience and competitiveness, health security, food security, and energy independence and security” ([NSCEB final report, About the Commission and Report, April 2025](https://www.biotech.senate.gov/final-report/chapters/about/)). That framing matters for readers who treat biology as a health portfolio rather than a security one.

**The threat is persistent rather than episodic.** The 2022 strategy lists persistence as its first assumption, noting that pathogens have emerged throughout history and that the risk grows as the world urbanizes, travel increases, and climate and habitats change, while nation-states and terrorist groups have found value in pursuing biological weapons ([National Biodefense Strategy and Implementation Plan, October 2022](https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf)).

## Why Biological Threats Differ from Chemical and Radiological Ones

Chemical, biological, radiological, and nuclear threats are grouped as CBRN for administrative convenience. The grouping obscures the property that drives biological risk.

### Spread versus bounded radius

A chemical agent or a radiological source harms what it reaches, and the quantity released sets an upper bound on the number of people the material itself can expose. The distinction that matters is not that chemical and radiological harm stops at a fence, because it does not, but that the hazard decays while a contagious biological hazard can grow. Chemical agents dilute and degrade, radioactive sources decay on a known half-life and can be found with a detector, and neither makes more of itself. A contagious pathogen multiplies in each person it infects, so the exposed population can keep growing after the release. Peer-reviewed security scholarship draws the line at replication: Koblentz defines pathogens as disease-causing microorganisms such as bacteria, rickettsiae, viruses, and fungi, and separates them from toxins, which are “nonliving molecules” that do not replicate in the body ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)).

Radiological and nuclear consequences are not confined to a radius either. In the Goiânia accident of September 1987 a caesium-137 teletherapy source was removed from an abandoned clinic in Brazil and broken open, and because the remnants were sold for scrap, shown to friends and relatives, and distributed as fragments, some 112,000 people were monitored, 249 were found contaminated internally or externally, four died, and the cleanup required demolishing seven residences ([IAEA, *The Radiological Accident in Goiânia*, 1988](https://www-pub.iaea.org/MTCD/publications/PDF/Pub815_web.pdf)). That is human movement spreading a hazard, the same mechanism that carries an epidemic, although the caesium did not multiply. The OTA comparison below puts a missile-delivered 1-megaton hydrogen bomb at 570,000 to 1.9 million deaths over an area of 190 square kilometers, far above the missile-delivered anthrax scenario in the same figure ([Office of Technology Assessment, 1993](https://digital.library.unt.edu/ark:/67531/metadc39715/m2/1/high_res_d/9341.pdf)). The biological claim worth defending is narrower: biological hazard is the only one of the four that can increase after release, through a process no one controls once it starts.

The US Office of Technology Assessment put numbers to the difference for Congress in 1993. Comparing single aircraft loads delivered as an aerosol line source, it estimated that 1,000 kg of sarin nerve agent would produce 300 to 8,000 deaths and 100 kg of anthrax spores 130,000 to 3 million deaths, across the three weather conditions it modeled, over a population density of 3,000 to 10,000 people per square kilometer ([Office of Technology Assessment, *Proliferation of Weapons of Mass Destruction: Assessing the Risks*, 1993](https://digital.library.unt.edu/ark:/67531/metadc39715/m2/1/high_res_d/9341.pdf)). Those figures assume “a highly efficient, line-source delivery of the killing agents” against unprotected populations, and OTA stated that under worse conditions the agents “might kill many fewer” ([Office of Technology Assessment, 1993](https://digital.library.unt.edu/ark:/67531/metadc39715/m2/1/high_res_d/9341.pdf)). Read as a planning scenario rather than a prediction, the comparison shows potency per unit of mass rather than spread: anthrax is not contagious, and these casualties come from the area the aerosol covers, not from transmission between people. A companion figure for missile delivery places 30 kg of anthrax at 30,000 to 100,000 deaths, a Hiroshima-size atomic bomb at 23,000 to 80,000, and a 1-megaton hydrogen bomb at 570,000 to 1.9 million, with the nuclear areas assumed to be air bursts producing little lethal fallout ([Office of Technology Assessment, 1993](https://digital.library.unt.edu/ark:/67531/metadc39715/m2/1/high_res_d/9341.pdf)).

The assumptions matter in the other direction too. The same OTA analysis judged that effective civil defense measures are considerably easier to take against chemical and biological weapons than against nuclear weapons when warning is available, and that the consequences of chemical and biological weapons are much less predictable than those of nuclear weapons because they depend on weather and protection ([Office of Technology Assessment, 1993](https://digital.library.unt.edu/ark:/67531/metadc39715/m2/1/high_res_d/9341.pdf)).

Contagion is not a property of every agent. The agents most studied for warfare have historically been infectious without being contagious, and a state contemplating a contagious agent faces the risk that the disease would spread back to the attacker ([Office of Technology Assessment, 1993](https://digital.library.unt.edu/ark:/67531/metadc39715/m2/1/high_res_d/9341.pdf)). A chapter that treats every pathogen as a potential pandemic overstates the deliberate threat, and a chapter that treats none of them that way understates it. The smallpox and plague agents that state programs did develop are contagious ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)).

The same growth applies to animals and crops, which is where biology’s economic reach is often largest. The UK government records that its 2001 foot and mouth disease outbreak cost the public sector £3 billion and the private sector a further £5 billion ([UK Biological Security Strategy, 2023](https://www.gov.uk/government/publications/uk-biological-security-strategy/uk-biological-security-strategy-html)), and the 2022 US strategy cites African swine fever and Ug99 stem rust alongside COVID-19 and Ebola as outbreaks showing that the government must be prepared to act swiftly ([National Biodefense Strategy and Implementation Plan, October 2022](https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf)). Agricultural outbreaks spread through animal movement and trade without any human case, so a biodefense posture built only around human disease misses part of the threat.

### Delay, travel, and the collapse of perimeter defense

Two measured features of respiratory infection explain why biological warning cannot work like radiation detection. First, symptoms lag exposure. An analysis of 181 confirmed COVID-19 cases with identifiable exposure and symptom-onset windows estimated a median incubation period of 5.1 days, with 97.5% of those who developed symptoms doing so within 11.5 days of infection ([Lauer et al., *Annals of Internal Medicine*, 2020](https://pmc.ncbi.nlm.nih.gov/articles/PMC7081172/)). Second, modern travel moves people faster than symptoms appear. As the outbreak emerged in January 2020, researchers used 2018 airline data to show that Bangkok, Hong Kong, Tokyo, and Taipei received the largest volumes of passengers from Wuhan, with 41,080, 23,707, 20,001, and 17,645 arrivals between January and March, respectively ([Bogoch et al., *Journal of Travel Medicine*, 2020](https://pmc.ncbi.nlm.nih.gov/articles/PMC7107534/)). A screening perimeter cannot stop what is already inside it and not yet symptomatic.

Military formations are not exempt. On the USS *Theodore Roosevelt*, a nuclear-powered aircraft carrier with a crew of 4,779, 1,271 crew members, 26.6% of the crew, tested positive for SARS-CoV-2, and more than 1,000 infections were identified within five weeks of the first laboratory-confirmed case ([Kasper et al., *New England Journal of Medicine*, 2020](https://pmc.ncbi.nlm.nih.gov/articles/PMC7675688/)). Among the 1,331 crew members with suspected or confirmed infection, 23 were hospitalized, 4 received intensive care, and 1 died, in a predominantly young crew, mean age 27, that met US Navy standards for sea duty ([Kasper et al., 2020](https://pmc.ncbi.nlm.nih.gov/articles/PMC7675688/)). The outbreak continued for at least six weeks after the ship docked in Guam on 27 March 2020 ([Kasper et al., 2020](https://pmc.ncbi.nlm.nih.gov/articles/PMC7675688/)). A pathogen that removes a capital ship from its station for weeks is a military problem whether or not anyone released it deliberately.

### Attribution

A missile has a launch point. An outbreak has an index case, and the first question about an index case is whether anyone caused it. OTA stated the problem in 1993: unlike nuclear and chemical weapons, the use of biological weapons might not be attributed to enemy attack, since outbreaks of disease can occur naturally ([Office of Technology Assessment, 1993](https://digital.library.unt.edu/ark:/67531/metadc39715/m2/1/high_res_d/9341.pdf)). Koblentz draws the strategic consequence: if a state or terrorist group believes it could attack anonymously and thereby escape retaliation, deterrence would be ineffective, and anonymous use raises the risk of catalytic war, a war between two states secretly initiated by a third party ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). The investigative mechanics of distinguishing natural from deliberate events are covered in [Attribution and Forensics](../governance/attribution-forensics.html), and the comparison with the chemical regime in [The Chemical Weapons Convention](../governance/chemical-weapons-convention.html).

### Dual use

Nuclear technology is dual-use too, through enrichment, reprocessing, and research reactors. The difference is that fissile material is scarce, countable, and subject to international accounting, which gives inspectors a chokepoint. Biological capability offers no equivalent. Koblentz identifies the dual-use nature of biotechnology as the core obstacle to verification, because the capabilities for research, development, production and testing of biological weapons are virtually identical to those used in defensive programs and legitimate civilian enterprises, and because advanced biotechnology removes the need for the large dedicated plants and filled munitions that would give inspectors a smoking gun ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). The oversight frameworks built around that problem are the subject of [Dual-Use Research of Concern](../frameworks/dual-use-research.html) and [DNA Synthesis Screening](../biotechnology/dna-synthesis-screening.html).

### One set of defenses for three kinds of event

Natural, accidental, and deliberate events differ in origin, in the law that applies, and in what deters them. They converge on the same response: detection, diagnosis, countermeasures, surge capacity, and trusted public communication. The 2022 strategy adopts that convergence as design, folding naturally occurring and accidental threats into biodefense on the grounds that doing so lets the government integrate and coordinate the enterprise and use biodefense assets efficiently ([National Biodefense Strategy and Implementation Plan, October 2022](https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf)). The three-category framework itself is set out in [The Biological Threat Landscape](../foundations/threat-landscape.html).

## What the Historical Record Shows

### 1918

The 1918 influenza pandemic infected an estimated one third of the world’s population, roughly 500 million people, with case-fatality rates above 2.5% compared with under 0.1% in other influenza pandemics and total deaths estimated at approximately 50 million and arguably as high as 100 million ([Taubenberger & Morens, *Emerging Infectious Diseases*, 2006](https://wwwnc.cdc.gov/eid/article/12/1/05-0979_article)). Nearly half of the influenza-related deaths were in adults aged 20 to 40, a pattern unique to that pandemic, and persons under 65 accounted for more than 99% of excess influenza-related deaths in 1918 and 1919 ([Taubenberger & Morens, 2006](https://wwwnc.cdc.gov/eid/article/12/1/05-0979_article)). A pathogen that kills working-age adults does damage to a state that mortality totals alone do not capture. Those totals are contested. A 2018 reassessment using the Human Mortality Database and British Indian records estimated roughly 17.4 million deaths worldwide and judged totals above 25 million unrealistic on the underlying mortality rates ([Spreeuwenberg et al., *American Journal of Epidemiology*, 2018](https://pmc.ncbi.nlm.nih.gov/articles/PMC7314216/)). Cite 1918 as a range whose low end is an order of magnitude below the familiar figure, not as a settled number. Taubenberger and Morens’ own forward-looking estimate is that a return of a virus equivalent in pathogenicity to that of 1918 “would likely kill \>100 million people worldwide” even with modern drugs, vaccines, and prevention knowledge ([Taubenberger & Morens, 2006](https://wwwnc.cdc.gov/eid/article/12/1/05-0979_article)).

### Amerithrax, 2001

Letters containing anthrax spores sent through the US mail in 2001 killed five Americans and sickened 17, in what the FBI calls the worst biological attack in US history, and the investigation became one of the largest and most complex in the history of law enforcement ([FBI, Amerithrax investigation](https://www.fbi.gov/history/famous-cases/amerithrax-or-anthrax-investigation)). The Justice Department, the FBI, and the US Postal Inspection Service formally concluded the investigation on 19 February 2010 and issued an Investigative Summary, after officials announced in August 2008 that charges were about to be brought against Dr. Bruce Ivins, who took his own life before they could be filed ([FBI, Amerithrax investigation](https://www.fbi.gov/history/famous-cases/amerithrax-or-anthrax-investigation)). A 2011 National Research Council review of the science the FBI used reached a narrower conclusion than the investigation did: “It is not possible to reach a definitive conclusion about the origins of the B. anthracis in the mailings based on the available scientific evidence alone,” and the genetic analyses were “consistent with” but did not demonstrate that the letter spores came from the flask the FBI identified ([National Research Council, 2011](https://nap.nationalacademies.org/read/13098/chapter/2)). Five deaths produced a national security response out of all proportion to the body count, and the case remains the clearest demonstration that scientific attribution of a biological event can fall short of what a prosecution needs.

### Biopreparat

The Soviet Union signed the Biological Weapons Convention and then expanded an offensive biological weapons program that at its peak was the world’s largest. [Biopreparat](https://nuke.fas.org/guide/russia/agency/bw.htm), established in 1973 a year after the Convention was signed, was its ostensibly civilian arm rather than the whole program; Defense Ministry bioweapons laboratories ran in parallel, with an additional 10,000 or so people working in them ([FAS, Biopreparat](https://nuke.fas.org/guide/russia/agency/bw.htm)). Koblentz records that Western intelligence lacked a clear understanding of it, quoting a 1970 US interagency report that “useful intelligence on actual production, weaponization and stockpiling remains nonexistent,” and notes that British and US intelligence doubled their estimates of the number of Soviet biological warfare facilities only after the 1989 defection of Vladimir Pasechnik ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). He also documents how secrecy defeated civilian control from the inside: a secret 1990 decree by Mikhail Gorbachev halting Biopreparat’s research, development, and testing carried a loophole, inserted by Biopreparat’s head, that allowed continued funding, and was withheld from institute directors, so its main effect was to conceal the program further from the Kremlin ([Koblentz, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). A treaty commitment is not a capability assessment. The program is treated in detail in [Case Studies](../governance/case-studies.html) and [The Biological Weapons Convention](../frameworks/bwc-governance.html).

### What COVID-19 cost

WHO estimated 14.83 million excess deaths globally for January 2020 to December 2021, with an uncertainty interval of 13.23 million to 16.58 million, which is 2.74 times the 5.42 million COVID-19 deaths reported to WHO for the period ([Msemburi et al., *Nature*, 2023](https://pmc.ncbi.nlm.nih.gov/articles/PMC9812776/)). The same analysis puts mean global per capita excess mortality at 0.06% in 2020 and 0.13% in 2021, above the influenza pandemics of 1957, 1968, and 2009, and far below the 1918 pandemic’s estimated 1.0% ([Msemburi et al., 2023](https://pmc.ncbi.nlm.nih.gov/articles/PMC9812776/)). Excess mortality is an estimate with wide uncertainty where all-cause mortality data are missing, and the authors caution that estimates for countries without such data must be interpreted with the greatest caution.

On the economic side, Cutler and Summers estimated the total US cost of the pandemic at more than \$16 trillion, roughly 90% of annual US GDP, combining \$7.6 trillion in lost output projected by the Congressional Budget Office with \$4.4 trillion for premature deaths, \$2.6 trillion for long-term health impairment, and \$1.6 trillion for mental health impairment ([Cutler & Summers, *JAMA*, 2020](https://doi.org/10.1001/jama.2020.19759)). The authors state the assumptions plainly: the figure rests on an optimistic assumption of substantial containment by the fall of 2021, a statistical life valued at \$7 million rather than the \$10 million often used in environmental and health policy, and a projection of 625,000 cumulative deaths through the following year ([Cutler & Summers, 2020](https://doi.org/10.1001/jama.2020.19759)). They note for comparison that the economic loss is more than twice the total monetary outlay for all the wars the US has fought since 9/11 ([Cutler & Summers, 2020](https://doi.org/10.1001/jama.2020.19759)). The mortality assumption was overtaken: CDC provisional data recorded 1,146,774 US deaths involving COVID-19 from January 2020 to September 2023, well above the 625,000 the estimate projected, so the mortality component of the \$16 trillion is low rather than high ([CDC NCHS, Provisional COVID-19 Deaths by Sex and Age](https://data.cdc.gov/NCHS/Provisional-COVID-19-Deaths-by-Sex-and-Age/9bhg-hcku)). The United Kingdom reported government spending of £321 billion on COVID-19 measures, with an estimated lifetime cost of £376 billion ([UK Biological Security Strategy, 2023](https://www.gov.uk/government/publications/uk-biological-security-strategy/uk-biological-security-strategy-html)). These are modeled totals built on contestable valuations of life and health, not accounting entries, and they should be cited as such.

## The US Architecture

### Strategy and statute

The governing document is the National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security, issued in October 2022 alongside National Security Memorandum-15, which updated the 2018 strategy and organized federal effort around five goals: risk awareness and detection, prevention, preparedness, rapid response, and recovery ([National Biodefense Strategy and Implementation Plan, October 2022](https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf)). Implementation progress was to be tracked through regular updates to the Global Health Security and Biodefense Directorate of the National Security Council as tasked in NSM-15 ([National Biodefense Strategy and Implementation Plan, October 2022](https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/10/National-Biodefense-Strategy-and-Implementation-Plan-Final.pdf)). That coordinating directorate was established by Executive Order 13987, which was rescinded on 20 January 2025, and KFF’s tracker of executive actions on global health notes that the elimination of the Directorate of Global Health Security and Biodefense and its Senior Director raises questions about which offices will fill the interagency coordination role ([KFF, Overview of President Trump’s Executive Actions on Global Health](https://www.kff.org/global-health-policy/overview-of-president-trumps-executive-actions-on-global-health/)). Readers should treat the 2022 strategy as the current published strategy while verifying which coordinating body is actually operating.

Statute sits underneath the strategy. 6 USC 104 requires the Secretaries of Defense, Health and Human Services, Homeland Security, and Agriculture to jointly develop a national biodefense strategy and implementation plan including a review and assessment of biodefense policies, practices, programs and initiatives, and to review and as appropriate revise the strategy biennially ([6 USC 104](https://www.govinfo.gov/content/pkg/USCODE-2023-title6/html/USCODE-2023-title6-chap1-sec104.htm)).

### Departments

Budget shares show where the mission actually sits. The Council on Strategic Risks, which tracks program-level biodefense spending and advocates for sustained investment, counts \$27.02 billion requested across the federal government for FY26, with the Department of Health and Human Services at \$19.44 billion, the Department of Defense at \$4.02 billion, and the Department of Agriculture at \$1.44 billion, each below FY25 enacted levels ([Council on Strategic Risks, December 2025](https://councilonstrategicrisks.org/2025/12/09/us-biodefense-budget-breakdown-fiscal-year-2026-update/)). DoD biodefense is 0.4% of a \$961.6 billion departmental request, and the Biological Threat Reduction Program under Cooperative Threat Reduction is requested at \$138.6 million against a \$235 million FY23 actual budget ([Council on Strategic Risks, December 2025](https://councilonstrategicrisks.org/2025/12/09/us-biodefense-budget-breakdown-fiscal-year-2026-update/)). The same analysis records that the Department of Homeland Security’s Countering Weapons of Mass Destruction Office is proposed for elimination with 286 positions and \$306 million transferred to other components, and that the Office of the Director of National Intelligence announced a reorganization in August 2025 that eliminated core functions of the National Counterproliferation and Biosecurity Center, which Congress had charged in the 2022 Intelligence Authorization Act with coordinating intelligence on biosecurity and foreign biological threats ([Council on Strategic Risks, December 2025](https://councilonstrategicrisks.org/2025/12/09/us-biodefense-budget-breakdown-fiscal-year-2026-update/)). This is an advocacy organization’s tally assembled from congressional budget justifications, and its own authors note that where biodefense-specific lines are unavailable the true figure is likely lower than reported.

The Department of Defense published its first Biodefense Posture Review in 2023 ([2023 Biodefense Posture Review](https://media.defense.gov/2023/Aug/17/2003282337/-1/-1/1/2023_BIODEFENSE_POSTURE_REVIEW.PDF)), and the Bipartisan Commission on Biodefense published its National Blueprint for Biodefense in 2024 with 36 recommendations and 185 action items ([National Blueprint for Biodefense, 2024](https://biodefensecommission.org/reports/the-national-blueprint-for-biodefense/)). The enterprise map and the congressional oversight landscape are described in [Policy Frameworks](../governance/policy-frameworks.html).

### NSCEB

Congress created the National Security Commission on Emerging Biotechnology in the FY22 National Defense Authorization Act to review emerging biotechnology’s impact on national security ([NSCEB final report, About the Commission and Report, April 2025](https://www.biotech.senate.gov/final-report/chapters/about/)). Its April 2025 final report contains 49 recommendations across six priority areas, recommends establishing a National Biotechnology Coordination Office within the Executive Office of the President, and asks Congress to invest a minimum of \$15 billion over five years in emerging biotechnology ([CRS Insight IN12546, 17 April 2025](https://www.congress.gov/crs_external_products/IN/HTML/IN12546.html)). The Commission cautions that China has made biotechnology a strategic priority for 20 years and that the United States must take swift action in the next three years or risk falling behind, “a setback from which we may never recover” ([CRS Insight IN12546, 17 April 2025](https://www.congress.gov/crs_external_products/IN/HTML/IN12546.html)). The Commission states that its report provides recommendations only within the scope of biotechnology, noting that biothreats exist without biotechnology and remain lethal and prevalent, and that the Bipartisan Commission on Biodefense and the DoD Biodefense Posture Review cover areas its report does not ([NSCEB final report, About the Commission and Report, April 2025](https://www.biotech.senate.gov/final-report/chapters/about/)). Competitiveness policy and biodefense policy overlap but are not the same portfolio, and conflating them is a common error in secondary coverage.

### What the intelligence community says

The Intelligence Community’s 2026 Annual Threat Assessment states that “the threats of nuclear proliferation and chemical and biological warfare capabilities continue to grow,” and assesses that China, North Korea, and Russia “probably maintain the knowledge and capability to produce and employ traditional biological pathogens and toxins,” and that they historically have pursued pathogens that cause highly infectious or contagious diseases, with North Korea assessed as continuing to pursue them ([ODNI, Annual Threat Assessment, March 2026](https://www.dni.gov/files/ODNI/documents/assessments/ATA-2026-Unclassified-Report.pdf)). On technology, it assesses that advances in dual-use biotechnology, including bioinformatics, synthetic biology, nanotechnology, and genomic editing, “could lead to novel biological threats or raise the potential for biological safety events resulting in the unintentional release of pathogens,” and that state programs pursuing novel industrial processes and bioenergy sources may also support the creation of antiagriculture, antimaterial, and antipersonnel agents ([ODNI, March 2026](https://www.dni.gov/files/ODNI/documents/assessments/ATA-2026-Unclassified-Report.pdf)). This is one government’s intelligence assessment presented without underlying evidence, written for a policy audience, and it should be read as the IC’s judgment rather than as independently verified fact. Koblentz’s survey of the historical record is the reason for that caution: threat assessments of foreign biological programs have produced both significant overestimates and significant underestimates, and the most important breakthroughs came from defectors rather than from analysis ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)).

## The International Layer

Three instruments carry the international load, and they fit together poorly.

**The Biological Weapons Convention** prohibits development, production, stockpiling, acquisition, and retention of biological weapons but contains no verification provisions, and negotiations on a protocol to strengthen it halted in 2001 after the United States declined to accept the draft ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). Koblentz records that even advocates of strengthening the Convention acknowledge that a verification regime sensitive to national security and commercial concerns will likely be unable to reliably detect violations ([Koblentz, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). The institutional history and the current state of play are covered in [The Biological Weapons Convention](../frameworks/bwc-governance.html).

**The International Health Regulations** bind 196 States Parties, including all 194 WHO Member States. Amendments adopted at the Seventy-seventh World Health Assembly entered into force on 19 September 2025, introducing a new level of global alert, a “pandemic emergency”, to trigger stronger international collaboration when a health risk escalates beyond a public health emergency of international concern, requiring governments to establish National IHR Authorities to coordinate implementation, and adding provisions on access to medical products and financing ([WHO, Amended International Health Regulations enter into force, 19 September 2025](https://www.who.int/news/item/19-09-2025-amended-international-health-regulations-enter-into-force)). For US readers the most consequential fact is that the United States is not participating: the 20 January 2025 executive order beginning US withdrawal from WHO directed the Secretary of State to cease negotiations on the Pandemic Agreement and the IHR amendments and stated that actions taken to effectuate them “will have no binding force on the United States” ([KFF, Overview of President Trump’s Executive Actions on Global Health](https://www.kff.org/global-health-policy/overview-of-president-trumps-executive-actions-on-global-health/)).

**The WHO Pandemic Agreement** was adopted by the Seventy-eighth World Health Assembly on 20 May 2025 under resolution WHA78.1 ([WHA78.1, 20 May 2025](https://apps.who.int/gb/ebwha/pdf_files/WHA78/A78_R1-en.pdf)). It is not yet law. The resolution notes that the Agreement opens for signature only after the Health Assembly adopts the annex described in Article 12, the Pathogen Access and Benefit-Sharing system, and Article 33 provides that the Agreement enters into force on the thirtieth day following deposit of the sixtieth instrument of ratification, acceptance, approval, formal confirmation, or accession ([WHA78.1, 20 May 2025](https://apps.who.int/gb/ebwha/pdf_files/WHA78/A78_R1-en.pdf)). As of 12 October 2026, when the UN General Assembly adopted a political declaration on pandemic prevention, preparedness and response, the PABS annex remained unfinished, and WHO stated that the outcome of the PABS negotiations will be considered at the World Health Assembly in May 2027 or earlier through a special session, with its adoption enabling the Agreement to enter into force ([WHO, 12 October 2026](https://www.who.int/news/item/12-10-2026-who-welcomes-adoption-of-united-nations-political-declaration-on-pandemic-prevention-preparedness-and-response)). The instrument most often described in public debate as the new pandemic treaty has no binding force, and will have none until sixty states ratify an agreement that cannot yet be signed. The negotiation history is in [Policy Frameworks](../governance/policy-frameworks.html).

## Where AI and Biotechnology Converge

The security argument above predates artificial intelligence and does not depend on it. What AI changes is who can act and how fast defenders must detect. The 2026 Annual Threat Assessment groups advances in bioinformatics, synthetic biology, nanotechnology and genomic editing as dual-use developments that “could lead to novel biological threats” ([ODNI, March 2026](https://www.dni.gov/files/ODNI/documents/assessments/ATA-2026-Unclassified-Report.pdf)), and NSCEB examined the convergence of AI and biotechnology, along with automation across the biotechnology research and development enterprise ([CRS Insight IN12546, 17 April 2025](https://www.congress.gov/crs_external_products/IN/HTML/IN12546.html)).

The handbook treats that convergence on its own evidence rather than by assertion. See [How AI Amplifies Biosecurity Risk](../ai-biosecurity/ai-risk-amplifier.html) for the uplift evidence and its limits, [AI and Pathogen Design](../ai-biosecurity/ai-pathogen-design.html) for the biological design tools, [Red-Teaming AI Systems](../ai-biosecurity/red-teaming.html) for how safeguards are measured, and [AI for Biosecurity Defense](../ai-biosecurity/ai-defense.html) for the defensive side. Nothing in the national security framing justifies treating speculative capability as demonstrated capability, and the evaluation literature is the place to check which is which.

## Open Questions and Dissent

**Does securitizing biology help or hurt?** Framing public health as national security attracts funding and senior attention. It also moves authority toward defense and intelligence institutions and can strain the scientific openness that detection depends on. Koblentz documents the mechanism from the other direction: the secrecy that surrounds biological weapons programs impedes verification, undermines deterrence, hinders civilian oversight, and complicates threat assessment, with examples from the Soviet Union and South Africa ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)).

**Do biological weapons deter?** The “poor man’s atomic bomb” description is widespread and Koblentz argues it is wrong, on the grounds that the availability of defenses places a premium on surprise, surprise requires strict secrecy, and credible deterrent threats would require revealing details of a capability that would then lose its effect ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). Other scholars, notably Susan Martin, have argued that biological weapons enable even small states to deter intervention by major powers; Koblentz engages that position directly and rejects it ([Koblentz, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)).

**Where should defensive investment go?** A deliberate attack and a natural pandemic share most defenses, but not all. Vaccination requires knowledge of the specific threat agent and time to vaccinate before an attack, and physical defenses such as filtered positive-pressure buildings are agent-agnostic but expensive ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). The FY26 request pattern, with medical countermeasures held roughly flat and public health preparedness and domestic health capacity requested 32% below FY24 actual levels, is one answer to that allocation question ([Council on Strategic Risks, December 2025](https://councilonstrategicrisks.org/2025/12/09/us-biodefense-budget-breakdown-fiscal-year-2026-update/)).

**How much weight should intelligence claims carry?** Assessments of foreign biological programs are statements of judgment by interested parties, and the record of overestimation and underestimation is long ([Koblentz, *International Security*, 2004](https://www.belfercenter.org/sites/default/files/pantheon_files/files/publication/koblentz.pdf)). Policy arguments that rest on a single government’s assessment, including the Annual Threat Assessment cited above, should say so.

**Is the international architecture adequate?** The Convention that bans biological weapons has no inspectorate, the regulations that govern outbreak reporting depend on states reporting against their own interests, and the agreement meant to close the access and benefit-sharing gap cannot enter into force until an unfinished annex is adopted and sixty states ratify ([WHA78.1, 20 May 2025](https://apps.who.int/gb/ebwha/pdf_files/WHA78/A78_R1-en.pdf); [WHO, 12 October 2026](https://www.who.int/news/item/12-10-2026-who-welcomes-adoption-of-united-nations-political-declaration-on-pandemic-prevention-preparedness-and-response)).

------------------------------------------------------------------------

*This chapter is part of [The Biosecurity Handbook](../index.html).*

The Biosecurity Handbook is free to read and cite, with no advertising. If this chapter informed your work, [you can support the handbook](../support.html).