Regulating Select Agent Chimeras: Defining the Problem(s) Through the Lens of SARS-CoV-1/SARS-CoV-2 Chimeric Viruses.

IF 2.1 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Health Security Pub Date : 2023-09-01 Epub Date: 2023-09-13 DOI:10.1089/hs.2023.0008
Elizabeth W Wells, Michael T Parker
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Abstract

In late 2021, the US Centers for Disease Control and Prevention (CDC) posted an interim final rule (86 FR 64075) to the federal register regulating the possession, use, and transfer of SARS-CoV-1/SARS-CoV-2 chimeric viruses. In doing so, the CDC provided the reasoning that viral chimeras combining the transmissibility of SARS-CoV-2 with the pathogenicity and lethality of SARS-CoV-1 pose a significant risk to public health and should thus be placed on the select agents and toxins list. However, 86 FR 64075 lacked clarity in its definitions and scope, some of which the CDC addressed in response to public comments in the final rule, 88 FR 13322, in early 2023. To evaluate these regulatory actions, we reviewed the existing select agent regulations to understand the landscape of chimeric virus regulation. Based on our findings, we first present clear definitions for the terms "chimeric virus," "viral chimera," and "virulence factor" and provide a list of SARS-CoV-1 virulence factors in an effort to aid researchers and federal rulemaking for these agents moving forward. We then provide suggestions for a combination of similarity and functional characteristic cutoffs that the government could use to enable researchers to distinguish between regulated and nonregulated chimeras. Finally, we discuss current select agent regulations and their overlaps with 86 FR 64075 and 88 FR 13322 and make suggestions for how to address chimera concerns within and/or without these regulations. Collectively, we believe that our findings fill important gaps in current federal regulations and provide forward-looking philosophical and practical analysis that can guide future decisionmaking.

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调节选择因子嵌合体:从严重急性呼吸系统综合征冠状病毒1/严重急性呼吸综合征冠状病毒2型嵌合体病毒的角度界定问题。
2021年末,美国疾病控制与预防中心(CDC)向联邦登记册发布了一项临时最终规则(86 FR 64075),对严重急性呼吸系统综合征冠状病毒1/严重急性呼吸综合征冠状病毒2型嵌合病毒的拥有、使用和转移进行了监管。在这样做的过程中,美国疾病控制与预防中心提出了这样的理由,即将严重急性呼吸系统综合征冠状病毒2型的传播性与严重急性呼吸综合征冠状病毒1型的致病性和致死性相结合的病毒嵌合体对公众健康构成了重大风险,因此应将其列入选定的病原体和毒素名单。然而,86 FR 64075在定义和范围上缺乏明确性,其中一些定义和范围是美国疾病控制与预防中心在2023年初的最终规则88 FR 13322中回应公众意见时解决的。为了评估这些调控作用,我们回顾了现有的选择因子调控,以了解嵌合病毒调控的前景。基于我们的发现,我们首先对“嵌合病毒”、“病毒嵌合体”和“毒力因子”等术语提出了明确的定义,并提供了严重急性呼吸系统综合征冠状病毒1型毒力因子的列表,以帮助研究人员和联邦规则制定这些制剂。然后,我们提出了相似性和功能特征临界值的组合建议,政府可以利用这些建议使研究人员能够区分受调控和非受调控的嵌合体。最后,我们讨论了当前的选择代理法规及其与86 FR 64075和88 FR 13322的重叠,并就如何在这些法规内和/或不在这些法规下解决嵌合体问题提出了建议。总的来说,我们相信我们的发现填补了当前联邦法规中的重要空白,并提供了前瞻性的哲学和实践分析,可以指导未来的决策。
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来源期刊
Health Security
Health Security PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
4.80
自引率
6.10%
发文量
70
期刊介绍: Health Security is a peer-reviewed journal providing research and essential guidance for the protection of people’s health before and after epidemics or disasters and for ensuring that communities are resilient to major challenges. The Journal explores the issues posed by disease outbreaks and epidemics; natural disasters; biological, chemical, and nuclear accidents or deliberate threats; foodborne outbreaks; and other health emergencies. It offers important insight into how to develop the systems needed to meet these challenges. Taking an interdisciplinary approach, Health Security covers research, innovations, methods, challenges, and ethical and legal dilemmas facing scientific, military, and health organizations. The Journal is a key resource for practitioners in these fields, policymakers, scientific experts, and government officials.
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