巴西高隔离和最高隔离实验室生物安全和生物安保条例与美国和其他国家法律框架的比较:差距和机遇

IF 0.5 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Applied Biosafety Pub Date : 2023-09-13 DOI:10.1089/apb.2023.0005

André de Oliveira Mendonça, Kurt Allen Zuelke, Melissa M. Kahl-Mcdonagh, Claudio Mafra

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引用次数: 0

摘要

导言:尽管美国和其他国家已经实施了全面的立法、法规和政策，以支持高度和最高限度控制实验室的生物安全和生物安全，但巴西的立法存在明显的差距和不一致之处。目的:评估巴西在确保全国生物安全和生物安全监督以及对高隔离和最高隔离实验室进行治理方面的做法。方法:进行了系统的差距分析，将巴西的生物安全和生物安全立法、法规和政策与国际同行进行比较，特别侧重于对高密封和最高密封实验室的监督和治理。结果:我们发现巴西生物安全和生物安全立法、法规和政策存在相关差距。巴西高隔离和最高隔离实验室的治理和监管是分散的，遵守普遍接受的全球生物安全和生物安全合规标准的程度各不相同。这些发现不仅表明在治理方面存在局限性，而且表明在巴西应对与突发传染病有关的当前和未来挑战的准备方面存在局限性。加强巴西实验室生物安全和生物安保的法律框架是必要和紧迫的。审查在美国和其他国际框架中吸取的经验教训和适用的法规，有助于确定提高巴西盘点和管理其多样化生物控制实验室能力的能力的潜在领域，并确保这些宝贵资源符合国家需要和优先事项。结论:巴西政府有机会利用其他国家公布的立法和指导方针，修订和完善一套针对其高和最高遏制实验室的国家立法、法规和政策。

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Comparison of Brazilian High- and Maximum-Containment Laboratories Biosafety and Biosecurity Regulations to Legal Frameworks in the United States and Other Countries: Gaps and Opportunities

Introduction: Although the United States and other countries have implemented comprehensive legislation, regulations, and policies to support biosafety and biosecurity of high- and maximum-containment laboratories, Brazil's legislation has notable gaps and inconsistencies. Objective: To evaluate the Brazilian approach to ensuring nationwide biosafety and biosecurity oversight and governance of high- and maximum-containment laboratories. Methods: A systematic gap analysis was conducted to compare Brazilian biosafety and biosecurity legislation, regulations, and policies with their international counterparts, with a particular focus on the oversight and governance of high- and maximum-containment laboratories. Results: We found that Brazilian biosafety and biosecurity legislation, regulations, and policies have relevant gaps. Governance and regulatory oversight of Brazil's high- and maximum-containment laboratories are decentralized with variable levels of adherence to commonly accepted global biosafety and biosecurity compliance standards. These findings represent a limitation not only to governance but also to the preparedness to face current and future challenges related to emergent infectious diseases in Brazil. Enhancing the Brazilian legal framework on laboratory biosafety and biosecurity is necessary and urgent. Reviewing the lessons learned and regulations applied in the United States and other international frameworks helped identify potential areas for improving Brazil's ability to inventory and manage its diverse biocontainment laboratory capabilities and assure these valuable resources align with national needs and priorities. Conclusion: The Brazilian government has an opportunity to revise and improve upon a national set of legislation, regulations, and policies for its high- and maximum-containment laboratories, taking advantage of legislation and guidelines published by other countries.

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来源期刊

Applied Biosafety Environmental Science-Management, Monitoring, Policy and Law

CiteScore

2.50

自引率

13.30%

发文量

期刊介绍： Applied Biosafety (APB), sponsored by ABSA International, is a peer-reviewed, scientific journal committed to promoting global biosafety awareness and best practices to prevent occupational exposures and adverse environmental impacts related to biohazardous releases. APB provides a forum for exchanging sound biosafety and biosecurity initiatives by publishing original articles, review articles, letters to the editors, commentaries, and brief reviews. APB informs scientists, safety professionals, policymakers, engineers, architects, and governmental organizations. The journal is committed to publishing on topics significant in well-resourced countries as well as information relevant to underserved regions, engaging and cultivating the development of biosafety professionals globally.