Biological hazards (biohazards) have long been recognized as a potential threat to the U.S. Department of Defense (DoD) and could originate from naturally occurring, accidental, and deliberate sources.1 The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic illustrated how a biological incident (bioincident) caused by an emerging infectious disease (EID) could impact the Joint Force. The risk of future pandemics from novel EIDs continues to increase due to multiple factors. In addition, while advancements in fields including biotechnology, nanotechnology, and artificial intelligence have the potential to revolutionize medicine, there is also the potential for misuse by adversaries.2  In response to this unprecedented biothreat environment, the U.S Government and the DoD have taken significant steps to assess and bolster biological defense (biodefense), that are outlined in the following documents:

  • The National Biodefense Strategy and Implementation Plan1
  • DoD Biodefense Posture Review (BPR)2
  • Army Biological Defense Strategy3

This guideline is designed to align with the objectives from the above documents. This CPG also aligns with DoD Medical Readiness Training policy DoD Instruction (DoDI) 1322.24, because it augments existing training material for triage, treatment, and management of patients exposed to biological agents.4  

This document is intended to be a general framework for military clinical personnel which consolidates and links to more detailed resources. Other referenced resources focus heavily on specific biothreats, and a vital goal of this guideline is to focus on augmenting clinical reasoning. An all-hazards clinical approach to biodefense would effectively capture all biothreats in an agnostic manner and would not require the traditional split into endemic and biowarfare agents. For that reason, this CPG is structured with the general all-hazards clinical approach with more detailed appendices for those interested in a particular area. Because Combatant Commands (CCMDs) greatly differ in climate, terrain, and resources, the JTS CPGs are not representative of a specific CCMD or contingency. Services, unit organizations, and other relevant stakeholders should tailor the concepts herein to unit missions, deployed settings, and unique situations. While doctrine is referenced in this document, this CPG is not DoD or Service doctrine and should not be misconstrued as such. This CPG will be updated as rapidly as possible as new threats emerge, or as new information on medical countermeasures (MCMs) are developed.  Figure 1 below serves as a quick guide to this CPG with hyperlinks to key topics, tables, and figures.

An all-hazards clinical approach to biodefense would effectively capture all biothreats in an agnostic manner and would not require the traditional split into endemic and biowarfare agents.
Figure 1. Guide to this CPG 

ESTABLISHING  KEY  DEFINITIONS

Definitions and terminology need to be emphasized, as there have been multiple terms in the biological space utilized over the years in DoD and medical culture. When most individuals think of biothreats, their thoughts tend to go to infectious diseases (IDs) such as anthrax, plague, and Ebola, or toxins such as botulinum or ricin, which are listed as “bioterrorism agents” or “biowarfare agents.” However, infectious diseases have been artificially separated into “endemic diseases” and “biological warfare agents” over time, for multiple reasons, within DoD and medical culture. This separation is not relevant to the clinician managing a patient, or patients presenting with various non-specific symptoms and signs when an all-hazards approach is needed. This CPG will utilize the definitions from the DoD BPR and the National Biodefense Strategy as a core, with supplementation from current U.S. doctrine, North Atlantic Treaty Organization (NATO) doctrine and other appropriate sources, when doctrinal definitions are not available. 

The following are key definitions to understand:

Biodefense:1,2  Actions to counter biological threats, reduce risks, and prepare for, respond to, and recover from bioincidents.

Biological Hazard (biohazard):1,2  A biological agent or biologically active substance, regardless of origin (e.g., naturally-occurring or bioengineered), that represents an actual or potential danger to humans, animals, plants, or the environment.Terms describing subtypes of potential biohazards:

  • Biological warfare (biowarfare) agent (BWA):5,6 A biological agent confirmed to have been modified, processed, or weaponized to be deliberately used to cause disease or death in humans, animals, plants, or material deterioration. Could include infectious diseases, toxins, or enabling and disruptive technologies.2
  • Emerging or re-emerging infectious diseases (EID):7,8 Infectious diseases whose incidence in humans has increased in the past two decades, or threatens to increase in the near future and include:
    • New infections resulting from changes or evolution of existing organisms.Examples: Emergence of SARS in 2003 and SARS CoV-2 in 2019.
    • Known infections spreading to new geographic areas or populations/Previously unrecognized infections appearing in areas undergoing ecologic transformation.Examples: 2022-2023 Mpox outbreak, Zika virus outbreak in 2015-2016, Nipah virus outbreak in Malaysia in 1998 (after deforestation and agricultural expansion).9
    • Infections reemerging as a result of antimicrobial resistance in known agents or with breakdowns in public health measures.Examples: Multidrug-resistant Neisseria gonorrhoeae, multi- and extensively drug-resistant tuberculosis.

Biological Incident (bioincident): 1,2

  • Any act of biological warfare or terrorism.

                 OR

  • A crime involving a biohazard.

                   OR

  • Any natural or accidental occurrence in which a biohazard harms the Total Force, consistent with the National Defense Strategy and the National Biodefense Strategy.

Biological threat (biothreat):1,2 An entity involved with, or a situation involving, a biohazard that can cause a bioincident.

Biological Select Agents and Toxins (BSAT):17 Biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products, which must meet specific handling or transportation requirements.Can be endemic, emerging or biowarfare agents.

Endemic diseases:10 The constant presence (with a certain frequency of circulation) of a disease or infectious agent within a given geographic area or population group; may also refer to an expected prevalence of a given disease within such area or group. Examples: Tropical IDs such as malaria and dengue, normal annual respiratory diseases.

High Consequence Infectious Disease (HCID):11,12,13 There is not a standardized definition for HCID amongst different sources at this time. However, per Joint Publications (JP) 4-02, an HCID is a disease that includes any confirmed or suspected infection with a pathogen that meets either of the following criteria:

  • A pathogen for which all forms of medical waste (including patient excreta, secreta, blood, tissue, tissue swabs, and specimens in transport media) are classified as category A infectious substances by the Department of Transportation.14

                OR

  • A pathogen with the potential to cause a high mortality rate among otherwise healthy people and:
    • At least some types of direct clinical specimens pose generalized risks to laboratory personnel.
    • Known risk of secondary airborne spread within health care settings or unknown mode of transmission.
    • No effective countermeasure exists.

Examples: Viral hemorrhagic fevers (Ebola, Lassa, others), Middle East respiratory syndrome (MERS), novel influenza viruses, Nipah virus, pneumonic plague, etc.11,13

Imported diseases:15 Infectious diseases originating in one geographically delineated ecosystem that are carried (by travel or immigration) to another geographically delineated ecosystem by an infected individual, animal, or disease vector.Example: Cholera in Haiti in 2010.

Medical intelligence:12 Produced by National Center for Medical Intelligence (NCMI) and consists of the collection, evaluation, and analysis of information concerning the health threats and medical capabilities of foreign countries and non-state actors that have immediate or potential impact on policies, plans, or operations.

Toxic Industrial Biologicals [TIBs]:16 Biological material that is manufactured, used, transported, or stored by industrial, medical, or commercial processes, which could pose an infectious or toxic threat.Example: Medical waste from a hospital or laboratory facility.

Toxin:6  The poisonous product of a living organism. A toxin can also be synthesized.