What Is Biosecurity?

The 2001 anthrax letters killed five people and exposed a critical weakness: the perpetrator was a government scientist with legitimate access to select agents. That insider threat sparked the most significant restructuring of U.S. biosecurity policy since the Biological Weapons Convention. Today, biosecurity has expanded far beyond laboratory security to encompass pandemic preparedness, AI-enabled biological threats, and synthetic biology governance across a global ecosystem of actors.

Learning Objectives
  • Distinguish biosecurity from biosafety and related concepts
  • Understand how biosecurity emerged as a distinct field
  • Identify key actors in the biosecurity ecosystem
  • Recognize the scope of modern biosecurity challenges

Core Definitions:

  • Biosafety: Protecting people and environment from biological agents through containment and safe laboratory practices (accidental harm prevention) (CDC BMBL)
  • Biosecurity: Protecting biological agents, materials, and information from theft, misuse, diversion, or intentional release (deliberate misuse prevention) (NTI, WHO)

Historical Evolution:

Biosecurity wasn’t always about AI and pandemics. The field evolved through distinct eras:

  • 1925-1972: Geneva Protocol prohibits use of biological weapons but allows production and stockpiling (BWC)
  • 1972-1975: Biological Weapons Convention (BWC) negotiated and enters into force, banning entire category of weapons
  • 1973-1992: Soviet Biopreparat program operates world’s largest offensive bioweapons program in BWC violation
  • 1995: Aum Shinrikyo attempts biological attacks in Japan (failed) but succeeds with chemical weapons
  • 2001: Anthrax letters kill 5, infect 22, fundamentally reshape U.S. biosecurity policy

Modern Biosecurity Ecosystem:

  • Government: CDC, BARDA, national health security agencies
  • International Organizations: WHO, FAO, BWC Implementation Support Unit
  • NGOs/Think Tanks: NTI, Johns Hopkins Center for Health Security, RAND
  • Academia: Research institutions, biosafety committees, institutional oversight
  • Industry: Biotechnology companies, DNA synthesis providers, pharmaceutical manufacturers

Key Assessment Tool:

Global Health Security Index (GHSI) benchmarks 195 countries across biosecurity and pandemic preparedness capacity. Developed by NTI and Johns Hopkins. Finding: No country fully prepared for pandemics as of 2019 and 2021 assessments.

Shared Responsibility Model: Effective biosecurity requires coordination across government, academia, industry, and civil society. No single sector can address biological risks alone.

Bottom Line: Biosecurity spans public health, national security, biotechnology governance, and international law. The field continuously expands as biological threats evolve from state bioweapons programs to AI-enabled information hazards.

Introduction

Working in pathogen genomics and surveillance during the COVID-19 pandemic might not seem like “biosecurity work.” Outbreak investigations. Running SARS-CoV-2 sequences. Helping state health departments interpret variant data. Supporting the Africa CDC with genomic surveillance infrastructure. Classic public health epidemiology.

But that work is central to biosecurity. Genomic surveillance detects threats early. Sequence data reveals pathogen origins and transmission chains. Surveillance infrastructure becomes the frontline defense against both natural outbreaks and deliberate releases. The distinction between public health practice and biosecurity often blurs in operational settings.

Biosecurity isn’t one thing. It’s laboratory safety protocols and international treaties. Select agent regulations and dual-use research oversight. Pandemic preparedness and bioweapons nonproliferation. This chapter unpacks those components. Definitions first. Then historical context showing how the field evolved. Finally, the current ecosystem of institutions and frameworks.

Defining Biosecurity vs. Biosafety

The Core Distinction

Biosafety and biosecurity address different threat models:

Biosafety protects people and the environment from biological agents through containment principles, technologies, and practices (CDC BMBL, WHO). The focus is preventing accidental exposure or release. Think: laboratory worker accidentally infects themselves with a BSL-3 pathogen. Or containment failure releasing agents into the environment.

Biosafety is well-established with widely accepted international guidance, largely derived from practical laboratory techniques and decades of operational experience.

Biosecurity protects biological agents, materials, and information from unauthorized access, theft, misuse, diversion, or deliberate release (NTI, WHO). The threat model is intentional harm. Think: insider threat stealing select agents from a laboratory. Or malicious actor accessing dual-use research to enhance pathogen transmissibility.

The WHO advanced the term “laboratory biosecurity” in 2006 to specifically address protection, control, and accountability of valuable biological materials within laboratories.

The Practical Summary

  • Biosafety: Protecting people from “bad bugs” (accidental harm)
  • Biosecurity: Protecting “bad bugs” from “bad people” (intentional harm)

Both are components of biorisk management, the integrated approach to identifying, assessing, controlling, and evaluating biological risks.

When They Overlap or Conflict

Most practices reinforce both biosafety and biosecurity. Restricted laboratory access prevents both accidental exposure and theft. Personnel training reduces both procedural errors and insider risk.

But sometimes they conflict. Clear labeling of dangerous pathogens improves biosafety but potentially decreases biosecurity. Balancing these tradeoffs requires institutional risk assessment.

Historical Context: How Biosecurity Emerged

Early Bioweapons Governance (1925-1972)

The 1925 Geneva Protocol prohibited the use of chemical and bacteriological weapons in warfare. Critical limitation: it didn’t prohibit development, production, or stockpiling. Many states ratified it with reservations, essentially making it a “no-first-use” agreement.

Post-World War II disarmament discussions continued but made limited progress until the UK initiative in 1968 proposed separating biological from chemical weapons, focusing first on a biological weapons ban.

The Biological Weapons Convention (1972-1975)

The United States unilaterally ended its offensive biological weapons program in 1969, creating diplomatic momentum. The USSR and USA tabled separate but identical drafts in August 1971.

The Biological Weapons Convention opened for signature April 10, 1972, in London, Moscow, and Washington, D.C. It entered into force March 26, 1975, after 22 states (including the three depositary governments) ratified it.

Historic significance: First multilateral disarmament treaty banning an entire category of weapons of mass destruction. As of 2025, 189 states are parties to the treaty.

Critical weakness: No verification mechanism. Compliance relies on national implementation and political will.

The Soviet Biopreparat Program (1973-1992)

While publicly supporting the BWC, the Soviet Union established Biopreparat in 1973, ostensibly a civilian pharmaceutical and biodefense organization but secretly the world’s largest offensive biological weapons program.

Scale: Dozens of research institutes, production plants, and testing facilities. Thousands of personnel across the Soviet Union.

Agents: Research and weaponization of anthrax, smallpox, plague, and other select agents.

Revelation: The program’s scope was largely revealed through defectors. Vladimir Pasechnik defected in 1989, providing initial details. Ken Alibek (Kanatzhan Alibekov) defected in 1992, offering extensive insider knowledge as former deputy director.

Biopreparat demonstrated that the BWC, without verification mechanisms, could be violated at massive scale for two decades while the international community remained largely unaware.

Aum Shinrikyo’s Failed Bioweapons (1990s)

Aum Shinrikyo, a Japanese cult, represents one of few documented cases of non-state actors extensively pursuing biological weapons. Despite significant financial resources, dedicated personnel, and scientific expertise, their biological program largely failed.

Attempts: Experimented with botulinum neurotoxin and Bacillus anthracis (anthrax). Multiple attempted deployments in Japan produced no reported injuries from biological agents.

Chemical “success”: In 1995, Aum Shinrikyo deployed sarin nerve gas in the Tokyo subway, killing 12 and injuring 5,000. This demonstrated the group’s willingness to cause mass casualties but also highlighted the practical difficulties of weaponizing biological agents compared to chemical weapons.

Key lesson: Even well-resourced, technically sophisticated actors face significant barriers to effective biological weapons deployment.

The 2001 Anthrax Letters: A Turning Point

In the weeks following September 11, 2001, letters containing Bacillus anthracis spores (Ames strain) were mailed to news media offices and U.S. Senators. Twenty-two people were infected. Five died.

Source: The investigation eventually implicated Dr. Bruce Ivins, a scientist at a U.S. government biodefense laboratory. The perpetrator had insider access to select agents.

Impact: The 2001 anthrax attacks served as a major turning point, sparking widespread concern and leading to significant restructuring of U.S. biosecurity measures. It demonstrated that biological threats could come from insiders with legitimate access, not just external adversaries.

Policy response: Prompted development of select agent regulations, enhanced laboratory security requirements, institutional biosafety committee oversight expansion, and significant funding for biodefense infrastructure.

The Modern Biosecurity Ecosystem

Government Actors

United States:

International:

  • WHO: Builds national biosafety and biosecurity capacity in member states through guidance documents, tools, technical assistance, and training. Laboratory biosafety and biosecurity included as core capacities under International Health Regulations (IHR 2005)
  • FAO: Addresses biosecurity in agricultural and veterinary contexts

Non-Governmental Organizations

Nuclear Threat Initiative (NTI):

  • NTI | bio program works to reduce catastrophic biological risks
  • Focus areas: strengthening biotechnology governance, preventing bioweapons development, advancing global health security, responding to high-consequence biological events
  • Key role in developing and supporting the Global Health Security Index

Johns Hopkins Center for Health Security:

  • Research institution at Bloomberg School of Public Health conducting biosecurity analysis and policy development
  • Partnership with NTI on Global Health Security Index

The Global Health Security Index (GHSI)

The GHSI is a comprehensive assessment and benchmarking tool evaluating health security and related capabilities across 195 countries.

Development: Partnership between NTI and Johns Hopkins Center for Health Security, initially with Economist Impact. Third edition developed with NTI, Brown University Pandemic Center, and Economist Impact.

Methodology: Measures countries across six categories, 37 indicators, and 171 questions using publicly available information.

Categories assessed:

  1. Prevention of pathogen emergence or release
  2. Detection and reporting of epidemics
  3. Rapid response capabilities
  4. Health system strength
  5. Adherence to international norms
  6. Risk environment

Key finding: The inaugural 2019 GHSI revealed no country was fully prepared for epidemics or pandemics. Subsequent editions continued to show dangerous unpreparedness globally.

Purpose: Inform leaders about foundational elements needed for outbreak preparedness, highlight gaps, and stimulate political will and investment.

Academia and Industry

Research institutions: Universities and research centers contribute through biosecurity research, training programs, and institutional biosafety committee oversight.

Biotechnology industry: Companies developing biological technologies, DNA synthesis providers, pharmaceutical manufacturers. Integral to both potential risks and solutions, necessitating engagement in governance.

Community stakeholders: Increasing recognition of “shared responsibility” (additional context) for biosecurity across governmental, industrial, scientific, and citizen sectors.

The Expanding Scope of Biosecurity

Historically, biosecurity focused on state bioweapons programs and laboratory security. The field now encompasses:

  • Pandemic preparedness: Natural outbreak detection and response capacity
  • Dual-use research oversight: Managing research with both beneficial and harmful applications
  • Synthetic biology governance: Democratization of DNA synthesis and gene editing
  • Information hazards: Publications and AI models revealing dangerous biological knowledge
  • Agricultural biosecurity: Protecting food systems from biological threats
  • Environmental biosecurity: Gene drives and ecological disruption risks

As biological technologies advance and become more accessible, biosecurity must continuously adapt. The threats that seemed theoretical a decade ago (AI-enabled pathogen design, benchtop DNA synthesis) are now operational realities requiring governance frameworks.

The One Health Approach

Modern biosecurity increasingly adopts a One Health framework, recognizing that human, animal, and environmental health are fundamentally interconnected. This integrative approach, formally endorsed by WHO, FAO, UNEP, and WOAH (World Organisation for Animal Health) in the Quadripartite One Health Joint Plan of Action, acknowledges that:

  • Most emerging infectious diseases are zoonotic: Approximately 60-75% of emerging infectious diseases originate from animals. SARS-CoV-2, Ebola, HIV, influenza, and Nipah virus all crossed species barriers.

  • Human-animal-environment interfaces are critical: Deforestation, agricultural expansion, wildlife trade, and climate change alter pathogen ecology and transmission dynamics. Biosecurity interventions must address these interfaces, not just laboratory settings.

  • Cross-sector collaboration is essential: Effective surveillance, outbreak response, and threat mitigation require coordination across human medicine, veterinary medicine, environmental science, and agricultural sectors.

The One Health framework shapes contemporary approaches to genomic surveillance (tracking pathogens across species), gain-of-function research governance (considering zoonotic spillover risks), and pandemic preparedness (understanding animal reservoirs). This integrative thinking appears throughout the handbook, particularly in chapters on surveillance (Outbreak Detection and Surveillance), emerging threats (The Biological Threat Landscape), and environmental biosecurity (Gene Drives and Environmental Biosecurity).

This chapter is part of The Biosecurity Handbook.