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根据特定病原体和毒素清单规定销毁微生物样本库。

Destruction of microbial collections in response to select agent and toxin list regulations.

作者信息

Casadevall Arturo, Imperiale Michael J

机构信息

Department of Medicine, Division of Infectious Diseases, Albert Einstein College of Medicine, Bronx, New York 10461, USA.

出版信息

Biosecur Bioterror. 2010 Jun;8(2):151-4. doi: 10.1089/bsp.2010.0012.

Abstract

In this study we have followed up on anecdotal and hearsay evidence that microbial collections were destroyed in the United States following the imposition of the regulations associated with the Select Agents and Toxins List, to validate or refute that information. Using a questionnaire, we documented 13 episodes of microbial collection destruction involving viral, bacterial, and fungal strains, which we believe is almost certainly an underestimate of the number of collections destroyed. In every case, the motivation for the destruction of the collection was a desire to avoid the perceived burdens of the regulatory environment associated with operating under the Select Agent Regulations. Some institutions that destroyed isolates considered, and in some cases tried, transferring their collections to registered institutions prior to collection destruction but desisted when confronted with transport regulations. Destruction of microbial collections represents a loss of strains and biological diversity available for biomedical research and future mechanistic, forensic, and epidemiologic investigations. Given the rapid evolution of microbial strains, the destruction of archival collections is a potentially irretrievable loss that was an unintended consequence of regulations to protect society against the nefarious use of biological agents. Furthermore, unregistered institutions continue to destroy newly acquired clinical isolates, thus preventing the establishment of new repository collections. We recommend that government agencies develop plans to ensure that microbial collections are preserved when considering future additions to microbial threat lists under which the possession of certain microbes is criminalized.

摘要

在本研究中,我们追踪了一些传闻和道听途说的证据,这些证据表明在美国实施与《特定病原体和毒素清单》相关的规定后,微生物样本被销毁,目的是验证或反驳这些信息。我们通过问卷调查记录了13起涉及病毒、细菌和真菌菌株的微生物样本销毁事件,我们认为这几乎肯定低估了被销毁样本的数量。在每一个案例中,销毁样本的动机都是为了避免在《特定病原体法规》下运营所带来的监管环境负担。一些销毁菌株的机构在销毁样本之前考虑过,并且在某些情况下尝试过,将其样本转移到注册机构,但在面对运输规定时放弃了。微生物样本的销毁意味着用于生物医学研究以及未来机制、法医和流行病学调查的菌株和生物多样性的损失。鉴于微生物菌株的快速进化,档案样本的销毁是一种潜在的无法挽回的损失,这是旨在保护社会免受生物制剂恶意使用的法规所带来的意外后果。此外,未注册机构继续销毁新获得的临床分离株,从而阻碍了新样本库的建立。我们建议政府机构制定计划,以确保在考虑未来增加微生物威胁清单(根据该清单,拥有某些微生物将被定为犯罪)时,微生物样本能够得到保存。

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