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发表于 2025-1-16 22:11:15 | 显示全部楼层 |阅读模式
美国商务部发布新规:对特定生物技术实验室仪器实施出口管制
美国商务部工业和安全局(BIS)今日发布临时最终规则(IFR),针对某些实验室仪器实施出口管制。
限制:
高参数和光谱流式细胞仪与细胞分选仪
这一决定源于生物技术与人工智能、数据科学结合后的双重属性:这些技术既能造福人类,也可能被某些国家用于增强军事能力,从而对美国国家安全构成潜在威胁。新规要求出口商在自动出口系统中提交电子出口信息,并对这些仪器提出新的许可要求,但某些目的地可获得许可例外。该规则已即刻生效,公众可在60天内提交意见。BIS强调,这些管制措施旨在关注特定国家的同时,确保国际社会能继续合理使用这些仪器推进生物技术的发展,这也是美国政府为应对关键技术相关的国家安全和外交政策问题所采取的最新举措。

原文请见:

Washington, D.C. – Today, the Department of Commerce’s Bureau of Industry and Security (BIS) released an Interim Final Rule (IFR) implementing targeted export controls on certain laboratory instruments. The United States recognizes that ensuring the responsible use of biotechnology, particularly when combined with advances in artificial intelligence (AI) and data science, is essential to safeguard public health, agriculture and food production, and the environment. At the same time, the United States needs to address the benefits and risks of biotechnology given the potential that its use, particularly when coupled with AI and biological design tools, could strengthen the military capabilities of countries of concern and pose threats to U.S. national security.
华盛顿特区 –今天,美国商务部工业和安全局 (BIS) 发布了一项临时最终规则 (IFR),对某些实验室仪器实施有针对性的出口管制。美国认识到,确保负责任地使用生物技术,特别是与人工智能(AI)和数据科学的进步相结合时,对于保护公众健康、农业和食品生产以及环境至关重要。与此同时,美国需要解决生物技术的好处和风险,因为生物技术的使用,特别是与人工智能和生物设计工具相结合时,可能会加强受关注国家的军事能力,并对美国国家安全构成威胁。

“Throughout the Biden-Harris administration, BIS and its interagency partners have carefully assessed critical technologies, including those related to biotechnology, to determine if additional export controls are warranted,” said Under Secretary for Industry and Security Alan F. Estevez. “We have strategically crafted these controls to focus on countries of concern while preserving the global community’s ability to responsibly use these laboratory instruments to advance the significant beneficial uses of biotechnology.”  
“在整个拜登-哈里斯政府期间,BIS 及其跨部门合作伙伴仔细评估了关键技术,包括与生物技术相关的技术,以确定是否有必要实施额外的出口管制,”负责工业和安全的副部长 Alan F. Estevez 说。“我们战略性地制定了这些控制措施,以关注关注的国家/地区,同时保留国际社会负责任地使用这些实验室仪器来推进生物技术的重要有益用途的能力。”

As noted in Executive Order 14081, emerging biotechnology capabilities have inherently dual-use applications: they promise great improvements in human wellbeing but have the potential to be misused by malign actors. The instruments controlled by this IFR are highly suitable for generating large, detailed biological datasets, which can be analyzed to discover complex patterns governing the function of biological molecules, cells, and organisms. This information has a wide range of civil and commercial applications. However, evidence suggests that certain countries are actively pursuing a strategy to exploit these techniques for asymmetric military advantage.
正如第 14081 号行政命令所指出的,新兴的生物技术能力本质上具有双重用途:它们有望极大地改善人类福祉,但有可能被恶意行为者滥用。由该 IFR 控制的仪器非常适合生成大型、详细的生物数据集,可以对其进行分析以发现控制生物分子、细胞和生物体功能的复杂模式。此信息具有广泛的民用和商业应用。然而,有证据表明,某些国家正在积极寻求利用这些技术获得不对称军事优势的战略。

This IFR controls the following instruments:
本 IFR 控制以下工具:

High-parameter and spectral flow cytometers and cell sorters, which are used to simultaneously measure multiple features of individual cells or particles, allowing scientists to rapidly produce large, high-information biological datasets.
高参数和光谱流式细胞仪和细胞分选仪,用于同时测量单个细胞或颗粒的多个特征,使科学家能够快速生成大型、高信息量的生物数据集。
Certain liquid chromatography mass spectrometers (LC/MS) specially designed for proteomics, the study of all or a significant portion of proteins produced and/or modified by an organism to elucidate the interactions, function, composition, and structures of proteins and their cellular activities.
某些液相色谱质谱仪 (LC/MS) 专为蛋白质组学而设计,蛋白质组学研究生物体产生和/或修饰的所有或大部分蛋白质,以阐明蛋白质的相互作用、功能、组成和结构及其细胞活动。
While this IFR imposes new license requirements for these instruments, license exceptions will be available for certain destinations. Exporters will also be required to file Electronic Export Information in the Automated Export System for certain exports.
虽然该 IFR 对这些工具提出了新的许可证要求,但某些目的地将提供许可证例外。对于某些出口,出口商还需要在自动出口系统中提交电子出口信息。

This IFR, which takes immediate effect, is the latest step in the administration’s ongoing efforts to address national security and foreign policy concerns related to critical technologies. BIS invites public comments on this IFR, which must be submitted no later than 60 days after the rule’s publication in the Federal Register. Information on submitting comments can be found in the “addresses” portion of the rule’s preamble.
这项 IFR 立即生效,是政府为解决与关键技术相关的国家安全和外交政策问题而持续努力的最新一步。BIS 邀请公众就本 IFR 发表意见,该评论必须在规则在《联邦公报》上发布后 60 天内提交。有关提交评论的信息,请参阅规则序言的 “addresses” 部分。

The text of the IFR is available on the Federal Register’s website here.   
IFR 的文本可在 Federal Register 的网站上找到 这里.
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