Artificially Engineered Carcinogenesis as a Biosecurity Threat: A Policy Review and Call for Inclusion in National and International Governance Frameworks

Abstract

Rapid advances in gene editing, synthetic biology and related biotechnologies have significantly expanded the range of biological interventions available for medical research and clinical practice. These innovations have contributed to major improvements in disease diagnosis, treatment, and prognosis worldwide. However, the same technological capabilities that enable therapeutic progress also introduce novel biosecurity challenges. Existing biosecurity and biosafety frameworks have historically prioritized infectious agents and transmissible pathogens, with comparatively limited attention given to non-communicable biological threats. One emerging but underexplored concern is the potential for carcinogenesis to be intentionally or unintentionally induced through engineered biological interventions, including genome editing platforms such as CRISPR-Cas9 systems, viral vectors, and synthetic regulatory elements. This policy review critically examines scientific evidence, ethical analyses, and governance literature to identify plausible pathways through which advanced biotechnologies could contribute to oncogenic risk. The review further evaluates existing international and national policy discussions that call for expanded oversight of dual use research of concern and emerging biotechnologies, highlighting gaps in current regulatory and surveillance mechanisms. This paper calls for the explicit recognition of artificially engineered carcinogenesis as a potential biosecurity threat. It proposes targeted policy measures to strengthen governance, including risk assessment frameworks, enhanced ethical review processes, and integration of oncogenic risk considerations into biosecurity strategies. Incorporating these measures into national and international biosecurity frameworks is essential to ensure responsible innovation while safeguarding public health and global security.