Gillum David R, Moritz Rebecca, Koblentz Gregory D
Research and Innovation, University of Nevada, Reno, NV, United States.
School for the Future of Innovation and Society, Arizona State University, Tempe, AZ, United States.
Front Bioeng Biotechnol. 2024 Oct 17;12:1474120. doi: 10.3389/fbioe.2024.1474120. eCollection 2024.
The rapid advancement of biological research and biotechnology requires a novel and robust regulatory agency to ensure uniform biosafety and biosecurity governance in the United States. The current fragmented regulatory landscape needs to be refocused to address the complexities of modern biological research, including risks associated with accidental, inadvertent, and deliberate biological incidents. An independent government agency, which we call the National Biosafety and Biosecurity Agency (NBBA), that is devoted to biosafety and biosecurity could effectively address these challenges. The NBBA would consolidate various regulatory functions, streamline processes, and enhance oversight. This oversight would encompass life sciences research in the United States, regardless of the source of funding or level of classification. The agency could also contribute to the bioeconomy by streamlining requirements to safeguard public health and the environment while fostering scientific and commercial progress. The proposed agency would govern high-risk biological pathogens, manage the Federal Select Agent Program, enforce policies related to dual use research of concern, pathogens with enhanced pandemic potential, and nucleic acid synthesis screening, administer regulations on the use and care of laboratory animals, as well as regulate other relevant biosafety and biosecurity activities. The goal would be to provide one-stop shopping for the biomedical research and biotechnology sectors subject to oversight by the Federal government. To ensure leadership in global biosafety and biosecurity, the agency's mission would include international collaboration, applied research, education, workforce development, and coordination with national security initiatives. Creating an agency like the NBBA will be politically challenging but presenting a comprehensive vision and engaging stakeholders early and frequently, and being transparent in the process, will be essential for garnering support. Creating a unified biosafety and biosecurity governance system in the United States will ensure the safe and secure advancement of biological research while sustaining innovation and maintaining international competitiveness.
生物学研究和生物技术的迅速发展需要一个新颖且强大的监管机构，以确保美国生物安全和生物安保治理的统一。当前分散的监管格局需要重新聚焦，以应对现代生物学研究的复杂性，包括与意外、无意和蓄意生物事件相关的风险。一个专门致力于生物安全和生物安保的独立政府机构，我们称之为国家生物安全和生物安保局（NBBA），能够有效应对这些挑战。NBBA将整合各种监管职能，简化流程并加强监督。这种监督将涵盖美国的生命科学研究，无论资金来源或保密级别如何。该机构还可以通过简化保障公众健康和环境的要求，同时促进科学和商业进步，为生物经济做出贡献。拟议中的机构将管理高风险生物病原体，管理联邦选择剂计划，执行与关注的两用研究、具有增强大流行潜力的病原体以及核酸合成筛查相关的政策，管理有关实验动物使用和护理的法规，以及监管其他相关的生物安全和生物安保活动。目标是为受联邦政府监督的生物医学研究和生物技术领域提供一站式服务。为确保在全球生物安全和生物安保方面的领先地位，该机构的使命将包括国际合作、应用研究、教育、劳动力发展以及与国家安全倡议的协调。创建像NBBA这样的机构在政治上具有挑战性，但提出全面愿景并尽早且频繁地吸引利益相关者参与，以及在过程中保持透明，对于获得支持至关重要。在美国建立一个统一的生物安全和生物安保治理体系将确保生物研究安全可靠地推进，同时维持创新并保持国际竞争力。
