Sharkey Curtis Matthew, Lekveishvili Mariam, de la Rosa Tricia, Danskin Katheen
Strategy Division, Office of Strategy, Policy, and Requirements, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, Washington, District of Columbia, USA.
Thriving Environments, San Diego, California, USA.
Appl Biosaf. 2024 Jun 20;29(2):63-70. doi: 10.1089/apb.2023.0036. eCollection 2024 Jun.
In response to continuous advancements in synthetic biotechnologies and in the availability of synthetic nucleic acids to the biological research community since the publication of the 2010 HHS synthetic double-stranded DNA (dsDNA) screening framework, the U.S. government undertook a comprehensive and stakeholder-driven review and revision process. This culminated in the publication of a new screening framework for synthetic nucleic acids in October 2023, followed by an Executive Order directing departments and agencies of the U.S. government to take certain measures in support of implementing the screening framework. This review provides an overview of the process by which stakeholder comments were considered and by which the 2023 screening framework was drafted. A summary of expected impacts on the life sciences research community is also provided.
Comments were solicited from synthetic biology stakeholders through the publication of two Notices, in 2020 and 2022. The 2020 Notice elicited 15 unique responses totaling 220 pages, and the 2022 Notice elicited 26 unique responses totaling 79 pages. These were considered by a deliberative interagency group, resulting in a revised screening framework in 2023.
The adoption of the 2023 screening framework, and related provisions in the Executive Order that followed, will impact researchers and biosafety officers across the U.S. bioeconomy. For instance, this screening framework is no longer limited in its recommendations to providers of synthetic dsDNA containing sequences unique to regulated pathogens or toxins, but now includes recommendations to all entities involved in the sale, use, and transfer of all forms of synthetic nucleic acids encoding genetic sequences that contribute to pathogenicity or toxicity-whether from regulated agents or not. Biosafety professionals are emerging as a critical resource for establishing and fostering a culture of biosecurity surrounding synthetic nucleic acids containing these high consequence genetic sequences.
The work presented is significant because the scope of the 2010 screening framework has been expanded to include roles and responsibilities for new entities across the life sciences research landscape. This will likely impact biosafety professionals, who may be well positioned in their institutions to coordinate these new responsibilities.
自2010年美国卫生与公众服务部（HHS）发布合成双链DNA（dsDNA）筛查框架以来，随着合成生物技术的不断进步以及合成核酸在生物研究领域的可得性增加，美国政府开展了一次全面且由利益相关者推动的审查和修订过程。这一过程最终在2023年10月发布了新的合成核酸筛查框架，随后发布了一项行政命令，指示美国政府各部门和机构采取某些措施以支持实施该筛查框架。本综述概述了考虑利益相关者意见以及起草2023年筛查框架的过程。同时还提供了对生命科学研究界预期影响的总结。
通过在2020年和2022年发布两份公告，向合成生物学利益相关者征求意见。2020年的公告收到了15份独特的回复，共计220页，2022年的公告收到了26份独特的回复，共计79页。一个跨部门审议小组对这些回复进行了审议，最终在2023年形成了修订后的筛查框架。
2023年筛查框架的采用以及随后行政命令中的相关规定，将对美国生物经济领域的研究人员和生物安全官员产生影响。例如，该筛查框架的建议不再局限于提供含有受管制病原体或毒素独特序列的合成dsDNA的供应商，现在还包括对所有参与销售、使用和转让所有形式编码有助于致病性或毒性遗传序列的合成核酸的实体的建议——无论这些序列是否来自受管制的病原体。生物安全专业人员正成为建立和培育围绕含有这些高风险遗传序列的合成核酸的生物安全文化的关键资源。
所开展的工作具有重要意义，因为2010年筛查框架的范围已扩大，涵盖了生命科学研究领域新实体的角色和责任。这可能会影响生物安全专业人员，他们在各自机构中可能处于协调这些新责任的有利位置。
