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Leveraging the Federal Select Agent Program to Oversee Nucleic Acids: Volume 2, Potential Benefits and Burdens, Recommendations, and Implementation Considerations

RAND | 2026-08-24 | health

Topics: AI, China, Cybersecurity, Europe, Indo-Pacific, Middle East, Nuclear, Russia, Trade, United States

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English Summary

The report argues that due to the democratization of biotechnology, existing Federal Select Agent Program (FSAP) authorities can be leveraged without new legislation to expand biosecurity oversight to cover synthetic genetic materials, including genes and fragments from non-select agents. This expansion is critical because modern advances increase the risk of dangerous pathogens being synthesized or modified using accessible nucleic acids. To achieve comprehensive biosecurity while protecting the U.S. bioeconomy, the authors recommend a phased, cautious implementation pathway that applies less stringent regulatory burdens than those currently used for viable select agent pathogens.

中文摘要

本報告提出,由於生物技術的民主化趨勢,現有的聯邦指定病原體計畫(FSAP)權限可無需制定新法規即可行使,將生物安全監管範圍擴展至涵蓋合成基因材料,包括源自非指定病原體的基因和片段。此項擴展至關重要,因為現代進步增加了利用易得核酸物質合成或改造危險病原體的風險。為在保護美國生物經濟的同時實現全面的生物安全,作者們建議採取分階段、審慎的實施路徑,其監管負擔應比目前針對活體指定病原體所使用的更為寬鬆。

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