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Volume 31, Number 8—August 2025

Perspective

Preparedness and Response Considerations for High-Consequence Infectious Disease

Justin Chan, Corri B. LevineComments to Author , Jocelyn J. Herstein, Nicole Cloutier, Lauren Sauer, Aneesh K. Mehta, Jared Evans, and on behalf of the Basic and Translational State of the Science Working Group of the National Emerging Special Pathogens Training and Education Center’s Special Pathogens Research Network1
Author affiliation: New York University Grossman School of Medicine, New York, New York, USA (J. Chan); The University of Texas Medical Branch at Galveston, Galveston, Texas, USA (C.B. Levine, N. Cloutier); University of Nebraska Medical Center, Omaha, Nebraska, USA (J.J. Herstein, L. Sauer, J. Evans); Emory University School of Medicine, Atlanta, Georgia, USA (A.K. Mehta)

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Table

Summary of major classification systems of infectious agents

Term Select agents and toxins Category Biosafety level Risk group Special pathogens and HCIDs (proposed)
Regulating or guiding organization(s)
 CDC; USDA
 US DOT Hazardous Materials Regulations
 CDC; NIH
 NIH
 None
Levels of classification
 SAT or Tier 1 SAT
 A and B
 1–4
 1–4
 NA
Scope of pathogens (animal vs. human vs. plant)
 Pathogens and toxins posing a severe threat to animals, plants, and humans
 Pathogens capable of infecting animals and humans
 Pathogens capable of infecting animals and humans
 Pathogens capable of infecting or causing harm to humans
 Pathogens capable of infecting humans
Purpose of classification
 Provide regulations on possession, use, and transfer of pathogens and toxins that have potential to pose a severe threat to the public, animal or plant health. The regulations allow laboratories to conduct important research on these materials in a safe and secure fashion.
 Provide regulations on how to safely handle and transport infectious waste that may be capable of causing permanent disability or death in humans or animals upon exposure to the substance.
 Provide guidance on the safe handling and containment of infectious microorganisms and hazardous biologic material to protect lab workers, the environment, and public from exposure to infectious microorganisms stored and handled in laboratories.
 Describe relative hazard posed by infectious agents or toxins in the laboratory.
 Provide guidance on human pathogens that require specialized clinical and public health response to prevent transmission in healthcare facilities and in the community.
Criteria related to classification
 Pathogens and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products.
 Category A classifies an infectious substance as in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. Category B classifies an infectious substance as not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs.
 BSLs 1–4 are associated with specific guidance on how to prevent exposure to certain pathogens that could pose an infectious risk to persons working in a laboratory.
 RG 1–4 are classified based on seriousness or lethality of human disease, whether preventive or therapeutic interventions are available, and risk posed to persons and the community.
 Special pathogens cause HCIDs with high illness and death, have few available medical countermeasures, and can transmit from person to person.
List of pathogens (1) (2) (3) (4) There is no universal list. Examples that meet criteria include Ebola, Marburg, and Nipah viruses.

*BSL, Biosafety Level; CDC, Centers for Disease Control and Prevention; DOT, Department of Transportation; HCID, high-consequence infectious disease; NA, not applicable; NIH, National Institutes of Health; RG, risk group; SAT, select agents and toxins; USDA, US Department of Agriculture; WHO, World Health Organization.

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1Group members are listed at the end of this article.

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