Bioengineering involves manipulating biological systems, often using techniques like CRISPR, to modify organisms for various purposes, including disease prevention and agricultural enhancement (McKinsey). While bioengineering offers potential benefits, it also raises significant risks, such as unintended consequences on ecosystems and human health (World Economic Forum, Gates Cambridge).

The possibility of engineered pathogens causing biological events of high consequence—such as pandemics, panzootics (animal disease outbreaks), or epiphytotics (plant disease outbreaks)—raises serious public health and safety concerns (University of Maryland). Accidental releases from laboratories or intentional use as biological weapons by state or non-state actors could lead to widespread disease outbreaks with devastating impacts on populations and ecosystems (U.S. Department of Defense, Observer Research Foundation, World Health Organization). Regulatory frameworks and ethical considerations are critical in managing these risks, as the consequences of a biological event can be profound and far-reaching (Carnegie Endowment). However, the dual-use dilemma, where bioengineering research could be used for both beneficial and malicious purposes, makes governance of the scientific community more difficult (Defence Against Bioterrorism, Bulletin of the World Health Organization).

Resolution Criteria:

• Pandemic: The World Health Organization (WHO) declares a Public Health Emergency of International Concern (PHEIC) because of the outbreak of an infectious disease or describes a disease as a pandemic in official reports or statements.
• Panzootic: The World Organisation for Animal Health (WOAH), Food and Agriculture Organization (FAO), or World Health Organization declares a disease to be a panzootic or describes a disease as panzootic in official reports or statements.
• Epiphytotic: A new plant disease outbreak is announced by the International Society for Plant Pathology (ISPP), Food and Agriculture Organization (FAO), or International Plant Protection Convention (IPPC).

• World Health Organization (WHO): The WHO may mention human bioengineering activity in a declaration of a “Public Health Emergency of International Concern” (PHEIC). PHEIC declarations provide a short background on the nature of the viral outbreak and may discuss human causation if applicable.
• UN Secretary-General’s Mechanism for Investigation of Alleged Use of Chemical and Biological Weapons (UNSGM): The UNSGM is the organization responsible for carrying out investigations in response to allegations of the possible use of biological weapons in violation of the UN Biological Weapons Convention. They may confirm that a human engineered biological weapon was used.
• Center for Disease Control’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), or another relevant U.S. Health and Human Services or CDC body.
• European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA)
• White House Office of Pandemic Preparedness and Response Policy (OPPRP)
• World Medical Association
• Other groups: A public declaration from a group of credible subject-matter experts that an infectious disease outbreak is likely to have been caused through human bioengineering activities may be sufficient for resolution, provided that the RFI team (in consultation with our stakeholders and subject matter experts) determines that the group is credible and has sufficient expertise and investigational resources to make that judgment.