The governance structures the world relies on to prevent biological research from being weaponized were built for a different era — one defined by state-sponsored anthrax programs and select-agent pathogens. A new proceedings publication from the National Academies of Sciences, Engineering, and Medicine warns that those frameworks are struggling to keep pace with a rapidly expanding biotechnology landscape in which synthetic DNA, multi-omics data, and AI-enabled biological design tools present dual-use risks that existing policies were never designed to assess.
The proceedings, published in 2026, summarize a four-part international workshop series convened between December 2024 and September 2025, engaging scientists, policymakers, and biosecurity experts from the United States, India, Mexico, Peru, and Argentina. The series focused on three case studies — human health multi-omics, crop improvement multi-omics, and DNA synthesis screening — to examine whether existing biosafety and biosecurity frameworks can adequately govern biotechnologies that do not involve pathogens or toxins but nonetheless carry significant potential for misuse.
The Dual-Use Gap Beyond Pathogens and Toxins
Current biosecurity frameworks — including those anchored in the Biological Weapons Convention, the Federal Select Agent Program, and U.S. dual-use research of concern policies — are oriented primarily around genetically modified organisms, pathogens, and toxins. Workshop participants and planning committee members repeatedly noted that emerging biotechnologies operate largely outside this regulatory perimeter. Research involving multi-omics analysis, synthetic biology, and AI-enabled biological modeling is increasingly capable of influencing human health, agriculture, and national security, yet is evaluated under criteria developed for a narrower threat landscape.
Kavita Berger of the National Academies observed during the workshop series that existing frameworks “are not necessarily reflecting the advances in the research,” and that the convergence of life sciences with disciplines such as computer science and artificial intelligence has expanded the possibilities of biological research into nearly every critical sector. The implication for public health and biodefense planners is significant: threat vectors no longer map neatly onto the regulatory categories that trigger oversight, review, or response.
DNA Synthesis: A Rapidly Evolving and Poorly Screened Risk Vector
The workshop devoted substantial attention to DNA synthesis as an immediate and actionable biosecurity concern. The cost of synthesizing DNA has fallen roughly 100-fold since 2000, enabling production of longer, more complex sequences by a far wider range of actors. Workshop participants noted that synthetic nucleic acids now figure centrally in CRISPR-based gene editing, PCR diagnostics, and vaccine development — but also that the same technologies could enable a well-resourced non-state actor to reconstruct dangerous pathogens or engineer existing ones to be more harmful.
The report described a biosecurity ecosystem that remains fragmented and inconsistent at the global level. Many small DNA synthesis providers are unaware that biosecurity screening is even an issue. AI-enabled biodesign tools further complicate the challenge, as they offer the potential to alter sequences of concern in ways that could evade detection while retaining dangerous function — a finding that, as one presenter noted, complicates efforts to develop best practices that can stand the test of time.
The EBRC has developed six categories of international best practices for nucleic acid synthesis screening, covering policy, sequence screening, customer screening, screening assessment, law enforcement reporting, and controls on benchtop synthesis equipment. Workshop participants emphasized that universal screening may be necessary to be truly effective — and that screening is only as useful as the global stakeholder network capable of adapting it as the risk landscape evolves.
Multi-Omics Data and the Security of Biological Information
The workshop series also examined multi-omics data — the integration of genomic, transcriptomic, proteomic, and metabolomic datasets — as an emerging biosecurity domain. Large-scale genomic databases, now operating in India, Latin America, and elsewhere, present risks of unauthorized access, data misuse, and exploitation for harmful purposes that existing data governance frameworks do not adequately address. Workshop participants noted that no frameworks governing data security in India currently define benefit assessment, and that international biosecurity documents focused on the bioeconomy largely omit dual-use risk considerations.
For public health practitioners and hospital preparedness planners, the multi-omics discussion carries a specific relevance: the same data infrastructure being built to enable precision medicine and personalized therapeutics could, if inadequately secured, expose population-level biological vulnerabilities to malicious actors.
Recommendations and the Path Forward
Workshop participants converged on several themes relevant to biodefense and public health preparedness. Proactive engagement by the scientific community was consistently emphasized: every time a new technology emerges without a corresponding risk framework, the response tends to be severe and restrictive, potentially halting beneficial research. Scientists were encouraged to engage policymakers directly, communicate real risks and real benefits clearly, and help build the regulatory environments in which responsible innovation can proceed.
International coordination was identified as essential. Nucleic acid synthesis screening standards developed by actors in the United States and Europe do not translate automatically to other national contexts — and without a global framework, gaps in screening coverage will persist regardless of what any single country requires. The IBBIS Global DNA Synthesis Screening Map was cited as one tool for identifying where those gaps currently exist.
Biological Threats in the Age of Emerging Biotechnology: Proceedings of a Workshop Series. National Academies Press, Spring 2026

